id|nct_id|outcome_type|title|description|time_frame|population|anticipated_posting_month_year|units|units_analyzed|dispersion_type|param_type
633629|NCT03231371|Secondary|Gadolinium Enhancement by Cardiac MRI|Categorical measure - yes or no; number of participants with gadolinium enhancement|Baseline MRI only|Only 9 participants had MRI data available. Remaining subjects (of 21) did not undergo MRI performed within study time frame.||Participants|||Count of Participants
633630|NCT03231371|Primary|Coronary Flow Reserve (CFR)|Ratio of peak to baseline coronary flow velocity (CFV)|Baseline testing (acute only), 3 minutes of adenosine infusion|Remaining subjects (of the 21 who completed) had unusable signal data.||ratio: peak to baseline CFV||Standard Deviation|Mean
633631|NCT03163134|Secondary|Number of Participants With Postoperative Complications|Determine the rate of any postoperative complications related to Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), Meningitis and Respiratory infections in EEA patients who received lumbar drain placement and EEA patients who did not receive lumbar drain placement.|1 year|||Participants|||Count of Participants
633632|NCT03163134|Primary|Number of Participants With Cerebrospinal Fluid (CSF) Leak|Determine the rate of CSF leak in endoscopic endonasal approach (EEA) patients who received lumbar drain placement and EEA patients who did not receive lumbar drain placement.|1month|||Participants|||Count of Participants
633633|NCT03159143|Secondary|Overall Survival|The overall survival will be calculated as the number of months from the date of first treatment until death or the cut-off date.|Up to 4 years|Patients received at least one cycle of docetaxel and oxaliplatin and were assessed for toxic effects.||months||95% Confidence Interval|Median
633634|NCT03159143|Secondary|Disease Control Rate (DCR)|Percentage of patients who achieved complete response, partial response and stable disease. DCR will be calculated from the first day of the first cycle to the date of metastatic or primary tumor relapse, or last contact date, or date of death (if death comes before disease progression), or data cut-off.|Up to 4 years|Patients who received at least one cycle of docetaxel and oxaliplatin and were assessed for toxic effects||percentage of participants||95% Confidence Interval|Median
633635|NCT03159143|Secondary|Time to Progression (TTP)|Time to progression (TTP) will be calculated as number of months from the date of first treatment to the date of disease progression or the date of death (disease-related causes) or the cut-off date.|Up to 4 years|Patients received at least one cycle of docetaxel and oxaliplatin and were assessed for toxic effects.||months||95% Confidence Interval|Median
633636|NCT03159143|Primary|Response Rate|Percentage of patients who experienced a greater than or equal to a 30% reduction in measurable disease, as per the RECIST criteria.|Up to 4 years|Patients who received between 1 and 6 cycles of oxaliplatin with docetaxel.||percentage of participants||95% Confidence Interval|Number
633637|NCT03157232|Primary|Sub-Range Performance Equivalence of Rainbow DCI and R1-25 Sensors by ARMS Calculation|Sub-range performance equivalence was determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter sensor to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square (Arms) error value.In order to obtain the Arms value, the blood sample hemoglobin value is subtracted from the pulse oximeter hemoglobin value for a number of samples, the average of this difference is computed as the bias. The standard deviation of these differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value.|1-5 hours per subject|||g/dL|||Number
633638|NCT03134326|Primary|Sub-Range Performance Equivalence of R2-25 and R1-25 Sensors by ARMS Calculation|Sub-range performance equivalence was determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter sensor to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square (Arms) error value. In order to obtain the Arms value, the blood sample hemoglobin value is subtracted from the pulse oximeter hemoglobin value for a number of samples, the average of this difference is computed as the bias. The standard deviation of these differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value.|1-5 hours|||g/dL|||Number
633639|NCT03134313|Primary|Accuracy of SpHb on R1-25 by Arms Calculation|Accuracy will be determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square (Arms) error value. In order to obtain the Arms value, the blood sample hemoglobin value is subtracted from the pulse oximeter hemoglobin value for a number of samples, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value.|1-5 hours per subject|||g/dL|||Number
633640|NCT03125031|Primary|Accuracy of Noninvasive Sensors by Arms Calculation|Accuracy will be determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square (Arms) error value. The accuracy results from both sensors will be assessed for equivalence|1-5 hours|||g/dL|data points||Number
633641|NCT03125018|Primary|Accuracy of Sensor by Arms Calculation|Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter to that obtained from a blood sample and calculating the arithmetic root mean square error (Arms) value. In order to obtain the Arms value, the blood oxygen saturation measurement is subtracted from the pulse oximeter oxygen saturation measurement for a number of samples, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value.|1-5 hours|||% of oxygen saturated hemoglobin|data points||Number
633642|NCT03125005|Primary|Accuracy of Sensor by Arms Calculation|Accuracy willl be determined by comparing the noninvasive blood methemoglobin measurement (expressed as a percentage of total hemoglobin) of the pulse oximeter to that obtained from a blood sample and calculating the arithmetic root mean square(Arms) error value.|5 hours|||Percentage of total hemoglobin|||Number
633643|NCT03124979|Primary|Accuracy of Sensor by Arms Calculation|Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter to that obtained from a blood sample and calculating the arithmetic root mean square(Arms) error value. In order to obtain the Arms value, the blood oxygen saturation measurement is subtracted from the pulse oximeter oxygen saturation measurement for a number of samples, the average of this difference is computed as the bias. The standard deviation of these differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value.|1-5 hours|||% of oxygen saturated hemoglobin|data points||Number
639120|NCT02406937|Secondary|Eczema Duration||Throughout the study period (84 days)|||Days||Standard Deviation|Mean
633644|NCT03124966|Primary|Accuracy of Sensor by Arms Calculation|Accuracy will be determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square(Arms) error value.|1-3 hours|||g/dL|||Number
633645|NCT03124927|Primary|Accuracy of Sensor by Arms Calculation|Accuracy will be determined by comparing the noninvasive blood methemoglobin measurement of the pulse oximeter to that obtained from a blood sample and calculating the arithmetic root mean square (Arms) error value.|5 hours|||percentage|||Number
633646|NCT03124901|Primary|Accuracy of Sensor|Accuracy willl be determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square(Arms) error value.|Up to 24 hours|||g/dL|||Number
633647|NCT03124836|Primary|Accuracy of Methemoglobin Measurement by Arms Calculation|Accuracy willl be determined by comparing the noninvasive blood methemoglobin measurement (expressed as a percentage of total hemoglobin) of the pulse oximeter to that obtained from a blood sample and calculating the arithmetic root mean square(Arms) error value.In order to obtain the Arms value, the blood sample methemoglobin value is subtracted from the pulse oximeter methemoglobin value for a number of samples, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value.|1-5 hours|||percentage of total hemoglobin|||Number
633648|NCT03124823|Primary|Accuracy of Sensor by Arms Calculation|Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter to that obtained from a blood sample and calculating the arithmetic root mean square(Arms) error value. In order to obtain the Arms value, the blood oxygen saturation measurement is subtracted from the pulse oximeter oxygen saturation measurement for a number of samples, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value.|1-5 hours|||% of oxygen saturated hemoglobin|data points||Number
633649|NCT03124797|Primary|Accuracy of Sensor by Arms Calculation|Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter to that obtained from a blood sample and calculating the arithmetic root mean square(Arms) error value. In order to obtain the Arms value, the blood oxygen saturation measurement is subtracted from the pulse oximeter oxygen saturation measurement for a number of samples, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value.|1-5 hours|||% of oxygen saturated hemoglobin|data points||Number
633650|NCT03124771|Primary|Accuracy of Sensor by Arms Calculation|Accuracy willl be determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square(Arms) error value.|1-5 hours|||g/dL|data points||Number
633651|NCT03124758|Primary|Accuracy of Sensor by Arms Calculation|Accuracy will be determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square(Arms) error value.|1-5 hours|||g/dL|data points||Number
633652|NCT03124693|Primary|Accuracy of Sensor by Arms Calculation|Accuracy will be determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square (Arms) error value.|Up to 24 hours|||g/dL|||Number
633653|NCT03119831|Other Pre-specified|Total Bacterial Counts (TBC)|Levels of bacterial counts, expressed in total bacterial DNA mass (ng) and total number of bacteria. TBC was evaluated by real-time Polymerase Chain Reaction (PCR).|Plaque samples were collected at the 14th postsurgical day.|The inconsistency between the overall number of participants analyzed and the numbers provided in the rows in the participant flow module is due to the fact that there were no microbiological data from three patients in Group B and from another three participants in Group C, because their pooled plaque samples were destroyed during processing.||log10 of copy numbers of bacterial DNA||Inter-Quartile Range|Median
633654|NCT03119831|Secondary|Plaque Area Index (PA%)|Assessment of the accumulation of dental plaque at buccal tooth surfaces between baseline (immediately before surgery), 7 and 14 days postoperatively. PA% referred at the percentage of the total buccal surface area of the included teeth covered by dental plaque. PA% values range between 0-100%|PA% was recorded at the 7th and 14th postoperative day|||percentage of buccal surface area||Inter-Quartile Range|Median
633655|NCT03119831|Secondary|Plaque Index (PI)|"PI measurements range between 0-3:
0 = No plaque
= A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface.
= Moderate accumulation of soft deposits on the tooth and gingival margin which can be seen with the naked eye.
= Abundance of soft matter on the tooth and gingival margin."|PI was recorded 14 days postoperatively|||units on a scale||Inter-Quartile Range|Median
633656|NCT03119831|Primary|Assessment of Periodontal Soft Tissue Healing Progress Between Baseline (Immediately After Surgery), 7 and 14 Days Postoperatively (Evaluated by Early Wound Healing Index - EHI)|"EHI measurements range between 1-5:
= Complete flap closure–no fibrin line in interproximal area.
= Complete flap closure–fibrin line in interproximal area.
= Complete flap closure–fibrin clot in the interproximal area.
= Incomplete flap closure–partial necrosis of interproximal tissue.
= Incomplete flap closure–complete necrosis of the interproximal tissue."|Early Wound Healing Index was recorded at the 7th and 14th postsurgical day|||units on a scale||Inter-Quartile Range|Median
633657|NCT03115853|Secondary|Difference in Mean Plasma Peak Aldosterone Levels||baseline to 18 weeks|data was lost and results are unknown|||||
633658|NCT03115853|Secondary|Difference in Mean Changes in Plasma Renin Activity.||baseline to 18 weeks||||||
633659|NCT03115853|Secondary|Difference in Mean Plasma Aldosterone Levels||baseline to 18 weeks||||||
633660|NCT03115853|Primary|Difference in Mean Plasma PAI-1 Level||baseline to 18 weeks|data was lost and results are unknown|||||
633661|NCT03115853|Primary|Difference in Peak Plasma PAI-1 Level||baseline to 18 weeks|data was lost and results are unknown|||||
633662|NCT03106870|Secondary|Number of Participants With Neonates Who Were Hypoglycemic|Neonatal hypoglycemia defined as a plasma glucose level of less than 30 mg/dL in the first 24 hours after delivery|24 hours after delivery|||Participants|||Count of Participants
633663|NCT03106870|Secondary|Number of Participants With a Macrosomic Baby|Fetal macrosomia has been defined birth weight greater than 4500 gm|24 hours after delivery|||Participants|||Count of Participants
633664|NCT03106870|Primary|Number of Participants With Glycemic Control Over Period From 20 Weeks to 36 Weeks Gestation|"Fasting and two-hours postprandial blood glucose every 48 hours, till reaching the target blood glucose concentrations:
60 - 95 mg/dl and < 120 mg/dl (for fasting and two-hour postprandial status, respectively) If patient reached blood glucose concentrations, she considered as controlled Diabetes Mellitus If patient did not reach blood glucose concentrations, she considered as uncontrolled Diabetes Mellitus"|from 20 weeks to 36 weeks gestation|||Participants|||Count of Participants
633665|NCT03106337|Primary|Shear-Wave Elastography (SWE) Values in kiloPascals (kPa)|Elastography provides a quantitative score of thyroid nodule stiffness that is expected to correlate with the biological nature of the nodule. Mean SWE values, in three planes: traverse plane, sagittal plane and transverse plane with nodule in the center, of all benign lesions were compared with mean SWE values of all malignant lesions on histopathology obtained post surgery.|Baseline (Day 0)|All enrolled participants.||kPa||Standard Deviation|Mean
633666|NCT03091751|Primary|Mean Difference of Mean Residence Time (MRT): BeneFIX Compared to AlphaNine|BeneFIX pharmacokinetic parameter of mean residence time (MRT 0-inf) was assessed and compared to the AlphaNine pharmacokinetic parameter (PK2 Study).|Baseline (prior to the infusion), and at 15 and 30 minutes, 1, 3, 6, 9, 24, 48, 72, and 74 hours following a single dose infusion of BeneFIX administered following a 7 to 15 day wash-out period.|Thirteen subjects with 2 prior pharmacokinetic assessments with AlphaNine (PK1, PK2) had a third PK assessment with BeneFIX (PK3). Nine subjects had PK3 analysis with BeneFIX as part of a previous study. In total, 22 subjects treated with BeneFIX (PK3) were analyzed jointly and compared to 25 subjects treated with AlphaNine (PK2).||hours||Standard Deviation|Mean
633667|NCT03091751|Primary|Mean Difference of Clearance: BeneFIX Compared to AlphaNine|BeneFIX pharmacokinetic parameter of clearance was assessed and compared to the AlphaNine pharmacokinetic parameter (PK2 Study).|Baseline (prior to the infusion), and at 15 and 30 minutes, 1, 3, 6, 9, 24, 48, 72, and 74 hours following a single dose infusion of BeneFIX administered following a 7 to 15 day wash-out period.|Thirteen subjects with 2 prior pharmacokinetic assessments with AlphaNine (PK1, PK2) had a third PK assessment with BeneFIX (PK3). Nine subjects had PK3 analysis with BeneFIX as part of a previous study. In total, 22 subjects treated with BeneFIX (PK3) were analyzed jointly and compared to 25 subjects treated with AlphaNine (PK2).||mL/min x kg||Standard Deviation|Mean
633668|NCT03091751|Primary|Mean Difference of Terminal Half-Life: BeneFIX Compared to AlphaNine|BeneFIX pharmacokinetic parameter of terminal half-life was assessed and compared to the AlphaNine pharmacokinetic parameter (PK2 Study).|Baseline (prior to the infusion), and at 15 and 30 minutes, 1, 3, 6, 9, 24, 48, 72, and 74 hours following a single dose infusion of BeneFIX administered following a 7 to 15 day wash-out period.|Thirteen subjects with 2 prior pharmacokinetic assessments with AlphaNine (PK1, PK2) had a third PK assessment with BeneFIX (PK3). Nine subjects had PK3 analysis with BeneFIX as part of a previous study. In total, 22 subjects treated with BeneFIX (PK3) were analyzed jointly and compared to 25 subjects treated with AlphaNine (PK2).||hours||Standard Deviation|Mean
633669|NCT03091751|Primary|Mean Difference of In Vivo Recovery: BeneFIX Compared to AlphaNine|BeneFIX pharmacokinetic parameter of in vivo recovery was assessed and compared to the AlphaNine pharmacokinetic parameter (PK2 Study).|Baseline (prior to the infusion), and at 15 and 30 minutes, 1, 3, 6, 9, 24, 48, 72, and 74 hours following a single dose infusion of BeneFIX administered following a 7 to 15 day wash-out period.|Thirteen subjects with 2 prior pharmacokinetic assessments with AlphaNine (PK1, PK2) had a third PK assessment with BeneFIX (PK3). Nine subjects had PK3 analysis with BeneFIX as part of a previous study. In total, 22 subjects treated with BeneFIX (PK3) were analyzed jointly and compared to 25 subjects treated with AlphaNine (PK2).||kg/dL||Standard Deviation|Mean
633670|NCT03091751|Primary|Mean Difference of Area Under the Curve (AUC): BeneFIX Compared to AlphaNine|BeneFIX pharmacokinetic parameter of area under the curve (AUC 0-inf) was assessed and compared to the AlphaNine pharmacokinetic parameter (PK2 study).|Baseline (prior to the infusion), and at 15 and 30 minutes, 1, 3, 6, 9, 24, 48, 72, and 74 hours following a single dose infusion of BeneFIX administered following a 7 to 15 day wash-out period.|Thirteen subjects with 2 prior pharmacokinetic assessments with AlphaNine (PK1, PK2) had a third PK assessment with BeneFIX (PK3). Nine subjects had PK3 analysis with BeneFIX as part of a previous study. In total, 22 subjects treated with BeneFIX (PK3) were analyzed jointly and compared to 25 subjects treated with AlphaNine (PK2).||IU x hour/dL||Standard Deviation|Mean
633680|NCT03070730|Secondary|Change in Physical Functioning-OI From Baseline|Measures of follow up testing will be the scores on the physical functioning subscale of the Orthostatic Intolerance Questionnaire.|1 week after first intervention||||||
633681|NCT03070730|Secondary|Change in Physical Functioning-EuroQOL From Baseline|Measures of follow up testing will be the scores on the physical functioning subscale of the EuroQOL.|1 week after third intervention||||||
633682|NCT03070730|Secondary|Change in Physical Functioning-EuroQOL From Baseline|Measures of follow up testing will be the scores on the physical functioning subscale of the EuroQOL.|1 week after second intervention||||||
633683|NCT03070730|Secondary|Change in Physical Functioning-EuroQOL From Baseline|Measures of follow up testing will be the scores on the physical functioning subscale of the EuroQOL.|1 week after first intervention||||||
651371|NCT02029755|Secondary|Rescue Analgesic Use||postoperative 1, 6, 12, 24, 36, 48 hour||||||
633675|NCT03072719|Secondary|Change From Baseline in Tactile (Yeaple) Pain Threshold on Post First Brushing (After 5 Minutes), Day 3 and Day 14|Tactile threshold was assessed by examiner using a constant pressure probe (Yeaple probe) which allowed application of a known force to the dentin surface from 10 g to an upper threshold of 80g in increments of 10 g. The tactile threshold is the maximum pressure applied at which participant do not report any pain or discomfort. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth.|Baseline, post first brushing (after 5 minutes), Day 3 and Day 14|Analysis for this outcome was conducted on ITT population which included all randomized participants who had at least one post baseline assessment of efficacy. n is the number of participants evaluated at specific time points for treatment arms respectively.||gram (g)||Standard Deviation|Mean
633676|NCT03072719|Secondary|Change From Baseline in Schiff Sensitivity Score on Post First Brushing (After 5 Minutes) and Day 3|Schiff sensitivity score was assessed by examiner as participant’s response to an evaporative (air) stimulus after the stimulation of each individual tooth. Response of participant was scored using Schiff sensitivity scale range of 0-3; 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicate improvement in sensitivity.|Baseline, post first brushing (after 5 minutes) and Day 3|Analysis for this outcome was conducted on ITT population which included all randomized participants who had at least one post baseline assessment of efficacy. n is the number of participants evaluated at specific time points for treatment arms respectively.||score on a scale||Standard Deviation|Mean
633677|NCT03072719|Primary|Change From Baseline in Schiff Sensitivity Score on Day 14|Schiff sensitivity score was assessed by examiner as participant’s response to an evaporative (air) stimulus after the stimulation of each individual tooth. Response of participant was scored using Schiff sensitivity scale range of 0-3; 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicates improvement in sensitivity.|Baseline, Day 14|Analysis for this outcome was conducted on intent-to-treat (ITT) population which included all randomized participants who had at least one post baseline assessment of efficacy. n is the number of participants evaluated at specific time point for treatment arms respectively.||score on a scale||Standard Deviation|Mean
633678|NCT03070730|Secondary|Change in Physical Functioning-OI From Baseline|Measures of follow up testing will be the scores on the physical functioning subscale of the Orthostatic Intolerance Questionnaire.|1 week after third intervention||||||
633679|NCT03070730|Secondary|Change in Physical Functioning-OI From Baseline|Measures of follow up testing will be the scores on the physical functioning subscale of the Orthostatic Intolerance Questionnaire.|1 week after second intervention||||||
678516|NCT01596842|Secondary|Change of Fetuin-A Levels||12 weeks||||||
633684|NCT03070730|Secondary|Change in Physical Functioning-FSS From Baseline|Measures of follow up testing will be the scores on the physical functioning subscale of the Fatigue Severity Scale.|1 week after third intervention||||||
633685|NCT03070730|Secondary|Change in Physical Functioning-FSS From Baseline|Measures of follow up testing will be the scores on the physical functioning subscale of the Fatigue Severity Scale.|1 week after second intervention||||||
633686|NCT03070730|Secondary|Change in Physical Functioning-FSS From Baseline|Measures of follow up testing will be the scores on the physical functioning subscale of the Fatigue Severity Scale.|1 week after first intervention||||||
633687|NCT03070730|Secondary|Change in Physical Functioning-MFI From Baseline|Measures of follow up testing will be the scores on the physical functioning subscale of the Multidimensional Fatigue Inventory (MFI).|1 week after third intervention||||||
633688|NCT03070730|Secondary|Change in Physical Functioning-MFI From Baseline|Measures of follow up testing will be the scores on the physical functioning subscale of the Multidimensional Fatigue Inventory (MFI).|1 week after second intervention||||||
633689|NCT03070730|Secondary|Change in Physical Functioning-MFI From Baseline|Measures of follow up testing will be the scores on the physical functioning subscale of the Multidimensional Fatigue Inventory (MFI).|1 week after first intervention||||||
633690|NCT03070730|Secondary|Change in Physical Functioning-CIS From Baseline|Measures of follow up testing will be the scores on the physical functioning subscale of the Checklist Individual Strength (CIS).|1 week after third intervention||||||
633691|NCT03070730|Secondary|Change in Physical Functioning-CIS From Baseline|Measures of follow up testing will be the scores on the physical functioning subscale of the Checklist Individual Strength (CIS).|1 week after second intervention||||||
633692|NCT03070730|Secondary|Change in Physical Functioning-CIS From Baseline|Measures of follow up testing will be the scores on the physical functioning subscale of the Checklist Individual Strength (CIS).|1 week after first intervention||||||
633693|NCT03070730|Secondary|Change in Physical Functioning- HADS From Baseline|Measures of follow up testing will be the scores on the physical functioning subscale of the Hospital Anxiety and Depression Scales.|1 week after third intervention||||||
633694|NCT03070730|Secondary|Change in Physical Functioning- HADS From Baseline|Measures of follow up testing will be the scores on the physical functioning subscale of the Hospital Anxiety and Depression Scales.|1 week after second intervention||||||
633695|NCT03070730|Secondary|Change in Physical Functioning- HADS From Baseline|Measures of follow up testing will be the scores on the physical functioning subscale of the Hospital Anxiety and Depression Scales.|1 week after first intervention||||||
633696|NCT03070730|Secondary|Change in Physical Functioning- 7 Item Patient Global Impression of Change From Baseline|"Measures of follow up testing will be the scores on the physical functioning subscale of the 7 item patient global impression of change with items anchored by :very much better to very much worse."|1 week after third intervention||||||
633697|NCT03070730|Secondary|Change in Physical Functioning- 7 Item Patient Global Impression of Change From Baseline|"Measures of follow up testing will be the scores on the physical functioning subscale of the 7 item patient global impression of change with items anchored by :very much better to very much worse."|1 week after second intervention||||||
633698|NCT03070730|Secondary|Change in Physical Functioning- 7 Item Patient Global Impression of Change From Baseline|"Measures of follow up testing will be the scores on the physical functioning subscale of the 7 item patient global impression of change with items anchored by :very much better to very much worse."|1 week after first intervention||||||
633699|NCT03070730|Secondary|Change in Physical Functioning-SF-36 Q From Baseline|Measures of follow up testing will be the scores on the physical functioning subscale of the SF-36 questionnaire.|1 week after third intervention||||||
633700|NCT03070730|Secondary|Change in Physical Functioning-SF-36 Q From Baseline|Measures of follow up testing will be the scores on the physical functioning subscale of the SF-36 questionnaire.|1 week after second intervention||||||
633701|NCT03070730|Secondary|Change in Physical Functioning-SF-36 Q From Baseline|Measures of follow up testing will be the scores on the physical functioning subscale of the SF-36 questionnaire.|1 week after first intervention||||||
633702|NCT03070730|Secondary|Change in Muscle Sympathetic Nerve Activity From Baseline||1 week after third intervention||||||
633703|NCT03070730|Secondary|Change in Muscle Sympathetic Nerve Activity From Baseline||1 week after second intervention||||||
633704|NCT03070730|Secondary|Change in Muscle Sympathetic Nerve Activity From Baseline||1 week after first intervention||||||
633705|NCT03070730|Secondary|Change in Vascular Resistance From Baseline||1 week after third intervention||||||
633706|NCT03070730|Secondary|Change in Vascular Resistance From Baseline||1 week after second intervention||||||
633707|NCT03070730|Secondary|Change in Vascular Resistance From Baseline||1 week after first intervention||||||
633708|NCT03070730|Secondary|Change in Heart Rate From Baseline||1 week after third intervention||||||
633709|NCT03070730|Secondary|Change in Heart Rate From Baseline||1 week after second intervention||||||
633710|NCT03070730|Secondary|Change in Heart Rate From Baseline||1 week after first intervention||||||
633711|NCT03070730|Secondary|Change in Blood Pressure From Baseline||1 week after third intervention||||||
633712|NCT03070730|Secondary|Change in Blood Pressure From Baseline||1 week after second intervention||||||
633713|NCT03070730|Secondary|Change in Blood Pressure From Baseline||1 week after first intervention||||||
633714|NCT03070730|Primary|Change in Fatigue Score on the Chalder Fatigue Questionnaire From Baseline|A 14 item self-report questionnaire. Subjects respond on a continuum of 1 to 4 questions evaluating fatigue intensity while distinguishing physical from mental fatigue.|2 weeks after second intervention||||||
633715|NCT03070730|Primary|Change in Fatigue Score on the Chalder Fatigue Questionnaire From Baseline|A 14 item self-report questionnaire. Subjects respond on a continuum of 1 to 4 questions evaluating fatigue intensity while distinguishing physical from mental fatigue.|2 weeks after first intervention||||||
633716|NCT03070730|Primary|Change in Fatigue Score on the Chalder Fatigue Questionnaire From Baseline|A 14 item self-report questionnaire. Subjects respond on a continuum of 1 to 4 questions evaluating fatigue intensity while distinguishing physical from mental fatigue.|up to 3 days after randomization||||||
633756|NCT03023553|Primary|Number of Participants From Each Arm Who Received Influenza Vaccine||Day 0 to 28|||Participants|||Count of Participants
633717|NCT03070730|Primary|Change Maximal Postural Tachycardia During Tilt|Maximal postural tachycardia is the maximum heart rate during a 20-min tilt table test.|2 weeks after second intervention||||||
633718|NCT03070730|Primary|Change Maximal Postural Tachycardia During Tilt|Maximal postural tachycardia is the maximum heart rate during a 20-min tilt table test.|2 weeks after first intervention||||||
633719|NCT03070730|Primary|Change in Maximal Postural Tachycardia During Tilt|Maximal postural tachycardia is the maximum heart rate during a 20-min tilt table test.|Up to 3 days after randomization||||||
633720|NCT03065933|Primary|Score on a Mania Rating Scale|Mania rating scale to be performed each day of this 3 day study.|3 days|No data was collected on the 5 participants, except for region of enrollment, before the study terminated.|||||
633721|NCT03061513|Secondary|Cerebral Redox Markers|Change from baseline in lactate levels at 8 weeks as determined by Magnetic Resonance Spectroscopy|at baseline and 8 weeks|||Ratio||Standard Deviation|Mean
633722|NCT03061513|Primary|Number of Adverse Events|The incidence and severity of adverse events in Parkinson disease patients taking 600mg ubiquinol or placebo daily over a 6 month period.|at 24 weeks|ITT||Number of Adverse Events|||Number
633723|NCT03055221|Primary|Effect of Long-term Remodulin Therapy on the NYHA Functional Classification|The NYHA functional classification ranges from I (subject's disease does not affect daily activities) to IV (subject's disease causes severe impairment).|The NYHA functional classification was assessed at each subject's last visit, which occurred up to approximately 9 years after first visit|Data presented include all subjects who underwent an NYHA functional classification assessment at their final visit. Not all subjects underwent an NYHA assessement at their final visit.||Functional Class||Standard Deviation|Mean
633724|NCT03055221|Primary|Effect of Long-term Remodulin Therapy on the 6-Minute Walk Distance (6MWD)|The intent of the 6-Minute Walk Test (6MWT) is to evaluate exercise capacity associated with carrying out activities of daily living.|The 6MWD was assessed at each subject's last visit, which occurred up to approximately 9 years after first visit|Data are presented for subjects who completed the 6MWT at their final visit. Not all subjects completed a 6MWT at their final visit.||Meters||Standard Deviation|Mean
633726|NCT03048383|Secondary|Adverse Events|We hypothesized that common minor events such as bruising and swelling at injection sites would occur equally for all treatment arms, but that no major adverse treatment effects would occur for any of the treatment arms. Major events are recorded here.|Up to 4 weeks post-treatment. Recorded at pre-treatment, 1 week, 2 weeks, and at 4 weeks.|||Adverse Events|||Number
633727|NCT03048383|Primary|Change in Synkinesis Assessment Questionnaire (SAQ) Scores|"The previously validated instrument, Synkinesis Assessment Questionnaire (SAQ), was administered in order to evaluate patient-perceived severity of synkinesis. This instrument was used for each of the three treatment arms and change in scores from baseline were compared at each time point between arms.
SAQ scores are calculated as the sum of scores for 9 questions, which each is scored from 1 to 5, divided by 45 and multiplied by 100. The total score therefore can range from 20 to 100. Lower SAQ scores represent less severe facial synkinesis, and higher scores more severe. We report here the mean total SAQ score each group. For additional information on the SAQ for facial synkinesis see Mehta et al. published in Laryngoscope in May 2007 (PMID: 17473697)."|Up to 4 weeks post-treatment. Recorded at pre-treatment, 1 week, 2 weeks, and at 4 weeks.|The Synkinesis Assessment Questionnaire (SAQ) was used to assess severity of facial synkinesis for each group. Total SAQ scores can range from 20 to 100. Lower SAQ scores represent less severe facial synkinesis, and higher scores more severe.||units on a scale||Standard Deviation|Mean
633728|NCT03048006|Secondary|Image Quality|"Image quality was evaluated with a 5-step scale from excellent to very poor (excellent/very good; good; moderate; poor and very poor)"|During MRI procedure|Image quality was missing for 108 patients.||Participants|||Count of Participants
633729|NCT03048006|Secondary|Diagnostic Value|"Diagnostic value was evaluated by answering yes or no to the following question Were you able to make a diagnosis based on the test results ?"|During MRI procedure|Diagnostic value was missing for 77 patients.||Participants|||Count of Participants
633730|NCT03048006|Primary|Frequency of Adverse Events|The frequency of adverse events (serious and non-serious) that occurred following injection of Dotarem was recorded.|From the beginning of the MRI procedure to 30–60 min after|||adverse events|||Number
633731|NCT03047447|Secondary|Ketones (Blood)|Ketones (blood) were measured at week 0 and week 3, 6 and 10 for the experimental ketogenic group, the control standard American diet group with no exercise, and the control standard American diet with 3-5 days of exercise per week (120-150 minutes/week). The change over time was calculated for ketones (blood) at week 10 minus ketones (blood) at week 0.|10-weeks|||mmol/L||95% Confidence Interval|Mean
633732|NCT03047447|Secondary|Body Fat Mass (Pounds of Body Fat)|BFM (body fat mass) was measured at week 0 and week 3, 6 and 10 for the experimental ketogenic group, the control standard American diet group with no exercise, and the control standard American diet with 3-5 days of exercise per week (120-150 minutes/week). The change over time was calculated for BFM at week 10 minus BFM at week 0.|10-weeks|||pounds||95% Confidence Interval|Mean
633733|NCT03047447|Secondary|BMI (Body Mass Index)|BMI (body mass index) was measured at week 0 and week 3, 6 and 10 for the experimental ketogenic group, the control standard American diet group with no exercise, and the control standard American diet group with 3-5 days of exercise per week (120-150 minutes/week). The change over time was calculated for BMI at week 10 minus BMI at week 0.|10-weeks|||kg/m^2||95% Confidence Interval|Mean
633734|NCT03047447|Secondary|Weight|Weight was measured at week 0 and week 3, 6 and 10 for the experimental ketogenic group, the control standard American diet group with no exercise, and the control standard American diet group with 3-5 days of exercise per week (120-150 minutes/week). The change over time was calculated for weight at week 10 minus weight at week 0.|10-weeks|||pounds||95% Confidence Interval|Mean
633735|NCT03047447|Primary|Hemoglobin A1c|Hemoglobin A1c (HgA1c) was measured at week 0 and week 3, 6 and 10 for the experimental ketogenic group, the control standard American diet group with no exercise, and the control standard American diet group with 3-5 days of exercise per week (120-150 minutes/week). The change over time was calculated for HgA1c at week 10 minus the HgA1c value at week 0.|Week 0 - Week 10|||% of hemoglobin||95% Confidence Interval|Mean
633736|NCT03043534|Secondary|Mechanics of Shaving|"A total of the Patient’s Global Assessment of mechanics of shaving based on following scale:
How easy is it to… (please rank each phrase from 1 to 4; 1 = very easy, 2 = easy, 3 = difficult, 4 = very difficult)
A) get a smooth shave after shaving? __________
B) shave stubborn hairs? __________
C) shave against the grain with little irritation? __________
D) shave with the grain with little irritation? __________
E) glide comfortably over your skin with the razor blade?
For each subject, the total score could range from 5 -20, with lower numbers indicating better shave mechanics"|6 weeks|||units on a scale||Standard Deviation|Mean
633737|NCT03043534|Primary|Patient Global Severity|"Patient’s Global Severity Assessment (Degree of Itching, Burning and Stinging) based on the following scale:
Please indicate how much immediate post shave itching/burning/stinging you are experiencing at this time on a scale of 1 to 5 (circle one):
= No itching/burning/stinging at all
= Mild or minimal itching/burning/stinging
= Moderate itching/burning/stinging
= Severe itching/burning/stinging
= Very severe (maximum itching/burning/stinging)"|6 weeks|||units on a scale||Standard Deviation|Mean
633738|NCT03041298|Primary|Frequency of Adverse Drug Reactions|The frequency of adverse drug reactions (serious and non-serious) that occurred following injection of Dotarem was recorded. Adverse drug reactions are adverse events related to the product administered.|From the beginning of the MR mammography procedure to 30-60 min after|||Adverse drug reactions|||Number
633739|NCT03041298|Primary|Cytology Test Results (Percentage of Patients Per Cytology Test Result)|Diagnoses were made according to the cytology test results. Percentage of patients per cytology test result was calculated. Multiple diagnoses were possible for the same patient.|During MRI procedure|A cytology test was performed in 232 patients.||Participants|||Count of Participants
633740|NCT03041298|Primary|Diagnostic Results (Percentage of Patients Per Diagnosis)|Diagnoses were made with MR images. Percentage of patients per diagnosis was calculated. Multiple diagnoses were possible for the same patient.|During MRI procedure|Diagnosis was achieved in 1523 patients but results were missing for 4 patients.||Participants|||Count of Participants
633741|NCT03041298|Primary|Ability to Make a Diagnosis|"Ability to make a diagnosis was evaluated by answering yes or no to the question Did the examination permit a diagnosis ?"|During MRI procedure|Ability to make a diagnosis was missing for 2 patients.||Participants|||Count of Participants
633742|NCT03041298|Primary|Image Quality|"Image quality was evaluated on a 5-point scale: excellent; good; moderate; poor and very poor."|During MRI procedure|Image quality was missing for 16 patients.||Participants|||Count of Participants
633743|NCT03039179|Secondary|"Pain (Score on the Numeric Rating Scale)"|"Pain Score on the Numeric Rating Scale > 3. The scale had values from 0 to 10 where zero represented no pain and 10 the worst possible pain. More than 3 means pain."|up to the first 3 days post intervention|||Participants|||Count of Participants
633744|NCT03039179|Primary|Heel Pressure Sores (Numbers of Participants With Heel Pressure Sores)|Numbers of Participants With Heel Pressure Sores of all grade Detected According to the Classification of the Scale of the National Pressure Ulcer Advisory Panel -N.P.U.A.P.: Grade 1: Non-blanchable erythema of intact skin. Discoloration of the skin, warmth, oedema, induration or hardness may also be used as indicators, particularly in individuals with darker skin. Grade 2: Partial thickness skin loss involving epidermis, dermis, or both. The ulcer is superficial and presents clinically as an abrasion or blister. Grade 3: Full thickness skin loss involving damage to or necrosis of subcutaneous tissue that may extend down to, but not through, underlying fascia. Grade 4: Extensive destruction, tissue necrosis, or damage to muscle, bone, or supporting structures with or without full thickness skin loss.|every day until discharge (expected average of 3 days)|||Participants|||Count of Participants
633745|NCT03037541|Secondary|Number of Participants With 75% Clearance|The secondary endpoint is number of participants that receive 75 % clearance of|24 weeks|||Participants|||Count of Participants
633746|NCT03037541|Primary|Number Participants With 100% Clearance|The primary endpoint is number of participants that receive 100% clearance of AK lesions from treatment initiation to end of treatment|24 weeks|||Participants|||Count of Participants
633747|NCT03035955|Primary|Demodex Count|number of demodex at Baseline and Week 4. Only Week 4 reported|Week 4|||number of demodex|||Number
633748|NCT03028987|Secondary|Number of Participants With Related Adverse Events|Number of individual twins who experienced related adverse events through the course of the study.|Day 0 to 28 post-immunization|||Participants|||Count of Participants
633749|NCT03028987|Primary|Number of Participants Who Received Influenza Vaccine|Number of individual twins who received either LAIV or IIV4 as dictated by their group assignment|Day 0|||Participants|||Count of Participants
633750|NCT03026803|Primary|Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Up to 2 years|||percentage of participants|||Number
633751|NCT03023709|Primary|Number of Participants With Related Adverse Events||Day 0 to 14 post-immunization|||Participants|||Count of Participants
633752|NCT03023709|Primary|Number of Participants Who Received Influenza Vaccine||Day 0|Study halted after Pilot Phase||Participants|||Count of Participants
633753|NCT03023683|Secondary|Number of Participants With Related Adverse Events||Day 0 to 28 post-immunization|||Participants|||Count of Participants
633754|NCT03023683|Primary|Number of Participants From Each Arm Who Received Influenza Vaccine||Day 0 to 28|||Participants|||Count of Participants
633755|NCT03023553|Secondary|Number of Participants With Related Adverse Events||Day 0 to 28 post-immunization|||Participants|||Count of Participants
651372|NCT02029755|Secondary|Nausea and Vomiting Categorical Score||postoperative 1, 6, 24, 48 hour||||||
633757|NCT03023488|Secondary|Post-Operative Characteristics - Complications|"The number of patients that had a complication in the first 1 month after the operation according to the Clavien Dindo Grading system (0-5).
Clavien Dindo Grading ranges from 0 (mildest) to 5 (most severe). 0. No complications
Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions. Allowed therapeutic regimens are drugs as antiemetics, antipyretics, analgesics, diuretics, electrolytes and physiotherapy. This grade also includes wound infections opened at the bedside
Complications requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included
Complications requiring surgical, endoscopic or radiological intervention
Life-threatening complications (including CNS complications) requiring IC/ICU management
Death"|The data will be recorded within 1 month after each procedure.|||Participants|||Count of Participants
633758|NCT03023488|Secondary|Operative Characteristics - Intraoperative Complications|The number of patients that has experienced any kind of intraoperative complications during the flexible ureteroscopy operation.|1 hour after the operation|||participants|||Number
633759|NCT03023488|Secondary|Operative Characteristics - Irrigation Pressure|The pressure that is applied to the irrigation solution which is circulated through the ureteroscope that is used to expand the renal cavities during a flexible ureteroscopy operation. the data will be collected in cmH2O. This pressure value is a constant value and it doesn't change throughout the length of the procedure.|1 hour after the operation|||cmH2O||Full Range|Median
633760|NCT03023488|Secondary|Duration of the Flexible Ureteroscopy Operation|the data about the duration of the operation that will be performed for each patient and the data will be recorded in minutes.|10 minutes after the operation|||min||Standard Deviation|Mean
633761|NCT03023488|Secondary|Technical Details - Name of Flexible Ureteroscope|Each ureteroscope has unique characteristics. So, every ureteroscope that will be used, will be recorded with its name. E.g. Storz Flex-X2, Olympus V1, Wolf Cobra|1 hour after the operation|||participants|||Number
633762|NCT03023488|Secondary|Technical Details - Size of Ureteral Access Sheath|The size of access sheaths will be given in French measurement. E.g. 10/12 Fr|1 hour after the operation|||participants|||Number
633763|NCT03023488|Primary|Pulsatility Index (PI) Calculation by Renal Doppler Ultrasound (US) Examination Evaluating the Effects of Flexible Ureteroscopy (F-URS) on Renal Blood Flow by Demonstrating the Change Between the Pre-operative and Post-operative Parameters.|"Doppler US will be performed at two times: 2 days prior to surgery and within the first 24 hours following F-URS to show the change between the pre-operative and post-operative periods. Doppler examination includes renal arteries and arcuate arteries. For each patient, the following parameters are measured: peak systolic velocities (PSV) and end diastolic velocities (EDV), resistive index (RI) and pulsatility index (PI) of the arteries. The unit for PSV and EDV is cm/sec. RI and PI doesn't have a unit, they are quantitative measures calculated from PSV and EDV.
Pulsatility index is calculated as the difference between PSV and EDV, divided by the mean velocity [(PSV – EDV) / ((PSV + EDV) / 2)].
Pulsatility index is used to discriminate between renal and pre-renal causes of acute kidney injury which can alter the therapeutic options in the clinical setting."|The doppler examination will be performed 2 days before surgery and the change will be assessed within 1 day of the operation. So, the initial evaluation will be performed and change of values will be assessed 72 hours after the initial evaluation|||unitless||Full Range|Median
633764|NCT03023488|Primary|Resistive Index (RI) Calculation by Renal Doppler Ultrasound (US) Examination Evaluating the Effects of Flexible Ureteroscopy (F-URS) on Renal Blood Flow by Demonstrating the Change Between the Pre-operative and Post-operative Parameters.|"Doppler US will be performed at two times: 2 days prior to surgery and within the first 24 hours following F-URS to show the change between the pre-operative and post-operative periods. Doppler examination includes renal arteries and arcuate arteries. For each patient, the following parameters are measured: peak systolic velocities (PSV) and end diastolic velocities (EDV), resistive index (RI) and pulsatility index (PI) of the arteries. The unit for PSV and EDV is cm/sec. RI and PI doesn't have a unit, they are quantitative measures calculated from PSV and EDV.
Resistive index is calculated as the difference between PSV and EDV, divided by PSV [(PSV – EDV) / (PSV)].
An increased resistive index can be considered as a marker of intrarenal arterial stiffness and is associated with worsening of renal function and tubulointersitial damage."|The doppler examination will be performed 2 days before surgery and the change will be assessed within 1 day of the operation. So, the initial evaluation will be performed and change of values will be assessed 72 hours after the initial evaluation|||unitless||Full Range|Median
633765|NCT03023488|Primary|End Diastolic Velocities (EDV) Measurement by Renal Doppler Ultrasound (US) Examination Evaluating the Effects of Flexible Ureteroscopy (F-URS) on Renal Blood Flow by Demonstrating the Change Between the Pre-operative and Post-operative Parameters.|"Doppler US will be performed at two times: 2 days prior to surgery and within the first 24 hours following F-URS to show the change between the pre-operative and post-operative periods. Doppler examination includes renal arteries and arcuate arteries. For each patient, the following parameters are measured: peak systolic velocities (PSV) and end diastolic velocities (EDV), resistive index (RI) and pulsatility index (PI) of the arteries. The unit for PSV and EDV is cm/sec. RI and PI doesn't have a unit, they are quantitative measures calculated from PSV and EDV.
EDV is the velocity in the renal and arcuate arteries at the end of the diastolic phase of each heart pulse."|The doppler examination will be performed 2 days before surgery and the change will be assessed within 1 day of the operation. So, the initial evaluation will be performed and change of values will be assessed 72 hours after the initial evaluation|||cm/s||Full Range|Median
633796|NCT03019783|Primary|Change in Flow-mediated, Endothelium-dependent Vasodilation|The investigators will evaluate flow-mediated, brachial artery vasodilation (percentage increase in diameter in response to a 5 minute ischemic challenge) at study entry and then after 28 days, with the change between the two measurements being the primary endpoint.|4 weeks|||percentage vasodilation||Standard Deviation|Mean
633817|NCT02977572|Secondary|Acute Renal Failure|Development of acute renal failure measured as increase of level of creatinine|Acute Renal Failure during intensive care unit stay (at discharge from intensive care unit)|||Participants|||Count of Participants
633818|NCT02977572|Secondary|Ventilator Acquired Pneumonia|Pulmonary infections (%) during stay at intensive care unit|Pulmonary infection at intensive care unit diagnosed until 72 hours after removal of ventilation|||Participants|||Count of Participants
639447|NCT02393950|Secondary|Dexterity and Reaction Times|Selected battery of psychomotor tests|Pre-dose and at 1 and 6h post dose at each dose level||||||
633766|NCT03023488|Primary|Peak Systolic Velocities (PSV) Measurement by Renal Doppler Ultrasound (US) Examination Evaluating the Effects of Flexible Ureteroscopy (F-URS) on Renal Blood Flow by Demonstrating the Change Between the Pre-operative and Post-operative Parameters.|"Doppler US will be performed at two times: 2 days prior to surgery and within the first 24 hours following F-URS to show the change between the pre-operative and post-operative periods. Doppler examination includes renal arteries and arcuate arteries. For each patient, the following parameters are measured: peak systolic velocities (PSV) and end diastolic velocities (EDV), resistive index (RI) and pulsatility index (PI) of the arteries. The unit for PSV and EDV is cm/sec. RI and PI doesn't have a unit, they are quantitative measures calculated from PSV and EDV.
PSV is the maximum velocity in the renal and arcuate arteries in the systolic phase of each heart pulse."|The doppler examination will be performed 2 days before surgery and the change will be assessed within 1 day of the operation. So, the initial evaluation will be performed and change of values will be assessed 72 hours after the initial evaluation|||cm/s||Full Range|Median
633767|NCT03023176|Secondary|Number of Participants With Related Adverse Events||Day 0 to 32 post-immunization|||Participants|||Count of Participants
633768|NCT03023176|Primary|Number of Participants Who Received Influenza Vaccine||Day 0 to 32|||Participants|||Count of Participants
633769|NCT03023137|Secondary|Neonates With Hypoglycemia|Hypoglycemia was defined as any blood glucose concentration ≤ 40 mg/dL.|One, two and fours hours after birth|A total of 153 babies were born alive in group W&D and 91 in the control group.||babies|||Number
633770|NCT03023137|Secondary|Appropriate-for-gestational Age Babies||End of pregnancy|A total of 153 babies were born alive in group W&D and 91 in the control group.||babies|||Number
633771|NCT03023137|Secondary|Babies Born at Term||End of pregnancy|A total of 153 babies were born alive in group W&D and 91 in the control group.||babies|||Number
633772|NCT03023137|Secondary|Live-born Children||End of pregnancy|A total of 153 babies were born alive in group W&D and 91 in the control group.||babies|||Number
633773|NCT03023137|Secondary|Second and Third-trimester Losses||28 weeks of gestation and end of gestation|Since we excluded multiple gestations, there were 174 single pregnancies in group W&D and 162 in the control group.||fetuses|||Number
633774|NCT03023137|Secondary|First-trimester Losses||14 weeks of gestation|Since we excluded multiple gestations, there were 174 single pregnancies in group W&D and 162 in the control group.||embryos|||Number
633775|NCT03023137|Secondary|Excessive Weight Gain|Weight gain >13 kg for underweight, normal weight or overweight mothers and > 9 kg for obese mothers|End of term pregnancies|A total of 148 pregnancies in group W&D and 57 pregnancies in the control group reached term.||mothers|||Number
633776|NCT03023137|Secondary|Mothers Who Used Heparin for Nephrotic Range Proteinuria or Placental Insufficiency||End of pregnancy|||mothers|||Number
633777|NCT03023137|Secondary|Preeclampsia||Pregnancies reaching 20 weeks' gestation|A total of 154 pregnancies reached 20 weeks in group W&D and 98 in the control group.||mothers|||Number
633778|NCT03023137|Secondary|Gestational Diabetes Mellitus||Pregnancies reaching 24 weeks' gestation|A total of 154 pregnancies in group W&D and 98 pregnancies in the control group reached 24 weeks of gestation.||mothers|||Number
633779|NCT03023137|Primary|Take-home Baby Rate||End of pregnancy|Since we excluded multiple gestations, there were 174 single pregnancies in group W&D and 162 in the control group.||babies|||Number
633780|NCT03022435|Secondary|Number of Participants With Related Adverse Events||Day 0 to 28 post-immunization|||Participants|||Count of Participants
633781|NCT03022435|Primary|Number of Participants Who Received Influenza Vaccine||Day 0|||Participants|||Count of Participants
633782|NCT03022422|Secondary|Number of Individual Twins With Related Adverse Events||Day 0 to 28 post-immunization|||Participants|||Count of Participants
633783|NCT03022422|Primary|Number of Individual Twins Who Received Influenza Vaccine||Day 0|||Participants|||Count of Participants
633784|NCT03022396|Secondary|Number of Individual Twins With Related Adverse Events||Day 0 to 28 post-immunization|||Participants|||Count of Participants
633785|NCT03022396|Primary|Number of Individual Twins Who Received Influenza Vaccine|All numbers reported are the number of participants, not the number of twin pairs. Each member of a twin was counted individually as a participant.|Day 0 to 28|All numbers reported are the number of participants, not the number of twin pairs. Each member of a twin was counted individually as a participant.||Participants|||Count of Participants
633786|NCT03020537|Secondary|Number of Participants With Related Adverse Events||Day 0 to 28 post-immunization|||Participants|||Count of Participants
633787|NCT03020537|Primary|Number of Participants Who Received Influenza Vaccine||Day 0 to 28|||Participants|||Count of Participants
633788|NCT03020498|Other Pre-specified|Investigate the Effects of Different Influenza Vaccines, Including Live Attenuated Vaccine (LAIV) and Inactivated Vaccine Delivered by Different Routes (Intranasal and IM), on B-cell Responses.||Day 0 to 28||||||
633789|NCT03020498|Secondary|Number of Participants With Related Adverse Events||Day 0 to 28 post-immunization|||Participants|||Count of Participants
633790|NCT03020498|Primary|Number of Participants Who Received Influenza Vaccine||Day 0 to 28|||Participants|||Count of Participants
633791|NCT03020472|Other Pre-specified|PBMC Samples Will be Tested by Flow Cytometry to Determine the Percentage of Influenza-specific Antibody Cells That Are CD27+CD38+CD19+ Plasmablasts and by ELISPOT.||Day 0 to Day 28||||||
633792|NCT03020472|Other Pre-specified|Post- Immunization B- Cell Response|Identify peak of the post-immunization B-cell responses following vaccination with live, attenuated influenza vaccine (LAIV)|5-13 days post immunization|Due to the low enrollment, the study was terminated and analysis was not performed.|||||
633793|NCT03020472|Secondary|Number of Participants With Related Adverse Events||Day 0 to Day 28|||Participants|||Count of Participants
633794|NCT03020472|Primary|Number of Participants Who Received Influenza Vaccine||Day 0 to Day 28|||Participants|||Count of Participants
633795|NCT03019783|Secondary|Change in Plasma Total Antioxidant Capacity|The investigators will evaluate plasma total antioxidant capacity at study entry and then after 28 days, with the change between the two measurements being the secondary endpoint.|4 weeks|||micromolar||Standard Deviation|Mean
633816|NCT02977572|Secondary|Length of Stay at Intensive Care Unit|Length of stay of the patient at Intensive Care Unit|Length of stay (days) at Intensive Care Unit at discharge from intensive care unit.|||days||Inter-Quartile Range|Median
651373|NCT02029755|Secondary|Sedation Scale||postoperative 1, 6, 24, 48 hour||||||
633797|NCT03002454|Primary|Number of Participants Analyzed for Diagnostic Efficacy of Technetium (99mTc) Medronate Injection Prepared With 99mTc Derived From Neutron-activation Produced 99Mo Imaging Sensitivity Versus 99mTc Derived From Fission-produced 99Mo Imaging Sensitivity.|All enrolled patients were re-imaged 3 to 28 days post a standard of care fission derived 99Mo bone scan using neutron-activation produced 99Mo as the investigational product. Per protocol dosage, time factors, injection site and imaging camera were matched. Resulting image sets (fission and neutron-activation) were analyzed visually for concordant biodistribution.|60 days|Each participant (4) acted as their own control to reduce variance. Paired image sets were analyzed visually for concordant biodistribution between the 99mTc Medronate Injection prepared with 99mTc derived from Neutron-activation produced 99Mo versus 99mTc Medronate Injection derived from Fission-produced 99Mo referenced as the baseline standard.||Participants|||Count of Participants
633798|NCT03001674|Primary|Impact of Intra-aortic Balloon Pump Activation on Left Ventricular Stroke Work.|We will be measuring left ventricular stroke work using a conductance catheter before and immediately after activation of an intra-aortic balloon pump (IABP). Left ventricular stroke work is quantified as the product of left ventricular pressure and volume. Conductance catheters are the primary method available for clinical measurement of left ventricular volume and pressure.|24 hours|||mmHg-mL||Standard Deviation|Mean
633799|NCT03001258|Primary|Screening Accuracy|The outcome was considered as accurate and coded as “1” if the screening result agreed with the gold standard. That is, if the screening result is positive for presbyopia and the refractionist also reported it as positive or the screening result is negative and the refractionist also reported as negative.|The study duration was for 5 months, however, data was collected by organizing the eye camps over 2 weeks period|||percentage of cases||95% Confidence Interval|Number
633800|NCT03000088|Primary|Time to Intubation||10 minutes around intubation|||seconds||Standard Deviation|Mean
633801|NCT02997904|Secondary|Total Number of Lice Removed, Total Number of Eggs Removed|Total number of lice removed after one hour of combing and total number of eggs removed after one hour of combing, analyzed separately|1 hour|Intent To Treat; including all subjects enrolled||Number of Lice or Number of Eggs||Standard Deviation|Mean
633802|NCT02997904|Primary|The Total Number of Lice + Eggs Removed From the Head After One Hour of Combing|A superiority analysis comparing the total number of lice + eggs removed from the head after one hour of combing with the Resultz Kit versus the control. The Resultz Kit was considered a success if the Resultz Kit was superior to the control.|1 hour|Intent To Treat; including all subjects who were enrolled in the study.||number of lice and eggs removed||Standard Deviation|Mean
633803|NCT02990910|Secondary|Median Survival Time of CHEOPS> 6 in the Two Groups.|Pain was assessed and recorded through the East Ontario children's hospital pain score (CHEOPS).When the CHEOPS>6,We thought it is painful. Comparing the median survival time (the time corresponding to pain percentage of 50% in two groups)of CHEOPS＞6 in two groups.|Time from entering the PACU until the patient leaves,approx 1 hour.|||minute||95% Confidence Interval|Median
633804|NCT02990910|Primary|Number of Participants With Respiratory Adverse Events in PACU(Postanesthesia Care Unit).|The main observation indexes was the incidence of respiratory adverse events in PACU, the ratio was the number of children who occurred respiratory adverse events to the total number of children. Respiratory adverse events were defined as an intervention requiring a nurse to maintain the SPO2 ≥95%.|Time from entering the PACU until the patient leaves,approx 1 hour.|||Participants|||Count of Participants
633805|NCT02988219|Secondary|The Prevention of Cardiac Arrhythmias Occurence by Epidural Anesthesia Added to General Anesthesia Evaluated by a Number and Type of Arrhythmias Observed|The investigator evaluates the incidence of cardiac arrhythmias depending on anesthesia method by observing the number and type of arrhythmias and whether additional interventions were needed to treat them|60 months|arrhythmias analysed: bradycardia, pause > 2s, supraventricular extrasystoles, ventricular extrasystoles; corrected QT interval (QTc)||Participants|||Count of Participants
633806|NCT02988219|Primary|Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Period|"The investigator evaluates the incidence of cardiac arrhythmias, the type of arrhythmias and whether additional interventions were needed to treat them
Arrhythmias observed:
tachycardia >100 bpm bradycardia < 50 bpm pause (P-P interval > 2 seconds) ventricular extrasystoles (VE) > 1000/ 24 hours supraventricular extrasystoles (SVE) >200/24 hours"|60 months|||Participants|||Count of Participants
633807|NCT02987374|Other Pre-specified|Proteomic Analysis of Antibody CDR3 Regions at 10 Different Time Points Before and After Immunization.|Proteomic analysis: Identification, production, and characterization of Influenza A specific antibodies and their CDRH3 amino-acid sequences.|Day -5 to 180 post-immunization||||||
633808|NCT02987374|Secondary|Number of Participants With Related Adverse Events||Day 0 to 180 post-immunization|Number of participants with related adverse events up to 180 days post immunization||Participants|||Count of Participants
633809|NCT02987374|Primary|Number of Participants Who Received Influenza Vaccine||Day 0 to 180 post-immunization|10 participants received the 2011-2012 Fluzone IIV3 vaccine||Participants|||Count of Participants
633810|NCT02986282|Secondary|Difference Between ABI Measured Before and After Electrical Cardioversion Using Doppler Method.|3 ABI measurements using doppler method were performed per participant and the Mean value was considered for each participant, and then a Median value was calculated across participants|Through the study period|||ratio||Inter-Quartile Range|Median
633811|NCT02986282|Primary|Difference Between ABI (Ankle - Brachial Index) Before Electrical Cardioversion Using Two Methods (Doppler and Oscillometric).|3 ABI measurements using both methods (doppler and oscillometric) were performed per participant and the Mean value was considered for each participant, and then a Median value was calculated across participants.|Through the study|||ratio||Inter-Quartile Range|Median
633812|NCT02977572|Secondary|Hospital Mortality|Mortality during hospital stay (including at Intensive care mortality)|Mortality (%) at Hospital at discharge from hospital|||Participants|||Count of Participants
633813|NCT02977572|Secondary|28th Day Mortality|Mortility of patients within of the first 28 days after randomization (either at intensive car unit or at hospital)|Mortality within 28 days of randomization|||Participants|||Count of Participants
633814|NCT02977572|Secondary|Intensive Care Unit Mortality|Mortality (%) at Intensive Care Unit|Mortality (%) at Intensive Care Unit at discharge from intensive care unit|||Participants|||Count of Participants
633815|NCT02977572|Secondary|Length of Hospital Stay|All the time (days) the patient stays at the hospital|Length of stay (days) at hospital at discharge from hospital|||days||Inter-Quartile Range|Median
633819|NCT02977572|Secondary|Duration of the Ventilation|Period of ventilation (either noninvasive ventilation or continouos positive airway pressure) while the patient suffers from acute respiratory failure secondary to cardiopulmonary edema|Time (hours) from start of ventilation until the removal of both devices because of improve or failure|||hours||Inter-Quartile Range|Median
633820|NCT02977572|Primary|Need for an Endotracheal Intubation Within Seven Days After Onset of Cardiopulmonary Edema at the Intensive Care Unit||Whitin seven days after onset of cardiopulmonary edema at the Intensive Care Unit|||Participants|||Count of Participants
633821|NCT02974543|Primary|Change in Tinnitus Loudness as Assessed by TinnTester|Change in Tinnitus matching loudness score (mean of weekly assessments for 4 weeks) from baseline tinnitus matching loudness score, for treatment and sham groups. Subjects are guided through a self-directed computerized assessment software that estimates how loud (in decibels) they perceive their tinnitus to be (TinnTester). This measure was performed at baseline, as well as time points following active, washout, or sham periods.|4 weeks on treatment (or sham)|First 3 columns represent the data from same 10 subjects at different time points who participated in the first arm (received active treatment before sham treatment). The last 3 columns represent data from the other 10 subjects at the same timepoints who participated in the 2nd arm (received sham treatment before active treatment).||dB||Standard Deviation|Mean
633822|NCT02974543|Primary|Change in TFI (Tinnitus Functional Index) After Treatment or Sham Compared to Baseline|Change in TFI score (mean of weekly assessments for 4 weeks) from baseline for treatment and sham groups. TFI is a clinical questionnaire that assesses tinnitus impact on a subject's quality of life. It uses a scale of 0 - 100 where 0 means no negative impact on quality of life from tinnitus and 100 is devastating impact It will be administered weekly through out the study.|Four weeks on treatment (or sham)|First 3 columns represent the data from same 10 subjects at different time points who participated in the first arm (received active treatment before sham treatment). The last 3 columns represent data from the other 10 subjects at the same timepoints who participated in the 2nd arm (received sham treatment before active treatment).||units on a scale||Standard Deviation|Mean
633823|NCT02971670|Secondary|Boosterability of BioMed rTSST-1 Variant Vaccine|ELISA IgG against rTSST-1. Boosterability was defined as an increase in TSST-1 Ab titer as compared to antibody titers after second vaccination.|through 6 months after third immunization|Out of 23 Subjects responding, 8 subjects were not interested to continue; 15 subjects were included as PP population.||Participants|||Count of Participants
633824|NCT02971670|Primary|Persistence of TSST-1 Antibodies|ELISA IgG against rTSST-1. Persistence of antibody was defined as a >/= 4-fold increase in TSST-1 Ab titer as compared to pre-vaccination values.|6-15 months after last immunization of Phase I|||Participants|||Count of Participants
633825|NCT02971670|Primary|Number of Participants With Adverse Events as a Measure of Safety|Clinical observation and clinical laboratory values|through 6 months|Out of 23 Subjects responding, 8 subjects were not interested to continue; 15 subjects were included as PP population.||participants|||Number
633826|NCT02964767|Secondary|Comparing CD4+ T Cell Count in HIV-Tb. and HIV Cases.|CD4 cell counts of HIV patients and HIV/co infection patients would be analysed by student T test, and p value would be estimated.|12 months|||cells/µL||Standard Deviation|Mean
633827|NCT02964767|Primary|Prevalence of HIV/Tb. co Infections Among Patients of HIV Enrolled at ART Center.|% Prevalence of HIV/Tb. co infections= no.of HIV/Tb. co infection (48)/total no. of enrolled patients of HIV including HIV/Tb. co infections (219) x 100, i.e. 21.9%|12 months|||participants|||Number
633828|NCT02961244|Secondary|Maintaining Normothermia Rate|"Within the surgery day, from patient bed through the operating room to PACU or ICU or back to patient bed.
With these results our intervention group's maintaining normothermia rates were higher respectively. ( p=0.001) For each patients around 11 temperature measurement had been made according to the operation time . If any measurement of any patients was <36 ºC , that patient accepted as hypothermic. (Failure to maintain normothermia)"|Surgery day|Patients and their results assessed on the basis of intention to treat per protocole.||Participants|||Count of Participants
633829|NCT02961244|Primary|Surgical Site Infection Rate|"Within the postoperative 30 days, if there is purulent exudate or nonpurulent but culture was pozitive, we accepted them as Surgical Site Infection (SSI) diagnosed.
All patients were made enough incision wide to explore their entire abdomen defined as Major Abdominal Surgery .
With this results between two groups intervention group had lesser rates of SSI respectively( (p=0.045 Mann Whitney U, n<30), (p=0.044 chi-square )"|Postoperative 30 days|Patients and their results assessed on the basis of intention to treat per protocole.||Participants|||Count of Participants
633830|NCT02959840|Secondary|Overall Anesthetic Care Satisfaction|Patients are asked their overall anesthetic care satisfaction (0 = Not Satisfied, 10 = Extremely Satisfied). Data are expressed as number of parturients who gave a score of 8 or higher.|During the surgical procedure|||Participants|||Count of Participants
633831|NCT02959840|Secondary|Satisfaction of Anti-emetic Treatment|Patients are asked their anti-emetic treatment satisfaction (0 = Not Satisfied, 10 = Extremely Satisfied). Data are expressed as number of parturients who gave a score of 8 or higher.|During the surgical procedure|||Participants|||Count of Participants
633832|NCT02959840|Secondary|Vomiting During Stage IV (the Rest of the Time Until Arrival at PACU)|The investigators will perform objective assessments of whether or not the patients have vomited during stage IV. The investigators will then analyze if there is a statistically significant difference between the number of patients that vomit in each group.|During the surgical procedure|||Participants|||Count of Participants
633833|NCT02959840|Secondary|Vomiting During Stage III (After Replacement of the Uterus and to the Next 15 Minutes)|The investigators will perform objective assessments of whether or not the patients have vomited during stage III. The investigators will then analyze if there is a statistically significant difference between the number of patients that vomit in each group.|During the surgical procedure|||Participants|||Count of Participants
633834|NCT02959840|Secondary|Vomiting During Stage II (After Eversion of the Uterus and Until Replacement of the Uterus)|The investigators will perform objective assessments of whether or not the patients have vomited during stage II. The investigators will then analyze if there is a statistically significant difference between the number of patients that vomit in each group.|During the surgical procedure|||Participants|||Count of Participants
634457|NCT02750267|Secondary|Distribution of Sensor and Meter Glucose Values (Median/Interquartile Range)|All subjects have CGM and handheld glucose meter output analyzed and compared between time on closed-loop system and time on usual care period.|72 hours||||||
633835|NCT02959840|Secondary|Vomiting During Stage I (After the Administration of CSE and Until Eversion of the Uterus)|The investigators will perform objective assessments of whether or not the patients have vomited during stage I. The investigators will then analyze if there is a statistically significant difference between the number of patients that vomit in each group.|During the surgical procedure|||Participants|||Count of Participants
633836|NCT02959840|Secondary|Nausea During Stage IV (the Rest of the Time Until Arrival at PACU)|Patients offer their subjective assessments of the level of nausea on a scale of 0-10 (0 = no nausea, 10 = worst nausea ever experienced) during stage IV. The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea in each group at this point. Patients that report nausea (1 or more on our scale) will be recorded as that they have experienced nausea.|During the surgical procedure|||Participants|||Count of Participants
633837|NCT02959840|Secondary|Nausea During Stage III (After Replacement of the Uterus and to the Next 15 Minutes)|Patients offer their subjective assessments of the level of nausea on a scale of 0-10 (0 = no nausea, 10 = worst nausea ever experienced) during stage III. The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea in each group at this point. Patients that report nausea (1 or more on our scale) will be recorded as that they have experienced nausea.|During the surgical procedure|||Participants|||Count of Participants
633838|NCT02959840|Secondary|Nausea During Stage II (After Eversion of the Uterus and Until Replacement of the Uterus)|Patients offer their subjective assessments of the level of nausea on a scale of 0-10 (0 = no nausea, 10 = worst nausea ever experienced) during stage II. The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea in each group at this point. Patients that report nausea (1 or more on our scale) will be recorded as that they have experienced nausea.|During the surgical procedure|||Participants|||Count of Participants
633839|NCT02959840|Secondary|Nausea During Stage I (After the Administration of CSE and Until Eversion of the Uterus)|Patients offer their subjective assessments of the level of nausea on a scale of 0-10 (0 = no nausea, 10 = worst nausea ever experienced) during stage I. The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea in each group at this point. Patients that report nausea (1 or more on our scale) will be recorded as that they have experienced nausea.|During the surgical procedure|||Participants|||Count of Participants
633840|NCT02959840|Primary|Vomiting|The investigators will perform objective assessments of whether or not the patients have vomited during the procedure. The investigators will then analyze if there is a statistically significant difference between the number of patients that vomit in each group.|During the surgical procedure|||Participants|||Count of Participants
633841|NCT02959840|Primary|Nausea|The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea at any point during the surgical procedure in each group.|During the surgical procedure|||Participants|||Count of Participants
633842|NCT02958995|Primary|Hazard Ratio for Risk of 10 Common Cancers Associated With Diabetes|The association between diabetes and risk of each of the 10 most common cancers was assessed by calculating hazard ratio using Cox proportional hazards regression models with control for available potential confounders: age, gender and calendar years. Cox regression techniques was used to examine the association between DM status and cancer risk with adjustment for potential confounding variables in the survey respondent cohort.|15 years|Analysis population included participants from KPNC registry (with or without diabetes) and had completed the MHS in the epidemiology study.||Ratio||95% Confidence Interval|Number
633843|NCT02958995|Primary|Age and Sex-Standardized Incidence Rates for the 10 Most Common Cancers Stratified by Diabetes Status|Age and gender adjusted incidence rates, stratified by diabetes status, was calculated using the direct method (2000 US Census as standard), with further stratification on calendar year. Cancer incidence rates were calculated with attention to the proper allocation of at-risk person-time. The association between diabetes and risk of each of the 10 most common cancers was assessed using Cox proportional hazards regression models with control for available potential confounders: age, gender. Similarly, Cox regression technique was used to examine the association between diabetes status and cancer risk among survey responders with adjustment for additional potential confounding variable.|15 years|Analysis population included participants from KPNC registry (with or without diabetes) and had completed the MHS in the epidemiology study.||Incidence per 100,000 person-years||95% Confidence Interval|Number
633844|NCT02958956|Secondary|Number of 10 Most Common Cancer Cases By Dose of Pioglitazone|The 10 most common cancer cases included: prostate, female breast, lung/bronchus, endometrial, colon, non-Hodgkin lymphoma, pancreas, kidney/renal pelvis, rectal, and melanoma associated with dose of pioglitazone. The various doses include 1-9000 mg, 9001-25000 mg, 25001-50000 mg and >=50001 mg.|15 years 5 months|Analysis population included T2DM participants who were identified from the KPNC Diabetes Registry in the study 1.The unexposed arm was not planned to be analyzed for this outcome measure.||Cases|||Number
633845|NCT02958956|Secondary|Hazard Ratio of the 10 Most Common Cancers Associated With Cumulative Dose of Pioglitazone|The hazard ratio of the 10 most common cancers: prostate, female breast, lung/bronchus, endometrial, colon, non-Hodgkin lymphoma, pancreas, kidney/renal pelvis, rectal, and melanoma associated with dose of pioglitazone. The various doses include 1-9000 mg, 9001-25000 mg, 25001-50000 milligram (mg) and greater than or equal to (>=) 50001 mg. Cox proportional hazards regression modeling was used to provide point and interval estimates of the dose. In all regression analyses, these measures of exposure to pioglitazone were treated as time-dependent covariates and time since entry into the cohort was the time scale.|15 years 5 months|Analysis population included T2DM participants who were identified from the KPNC Diabetes Registry in the study 1.||Ratio||95% Confidence Interval|Number
633846|NCT02958956|Secondary|Number of 10 Most Common Cancer Cases by Duration of Pioglitazone|The 10 most common cancer cases included: prostate, female breast, lung/bronchus, endometrial, colon, non-Hodgkin lymphoma, pancreas, kidney/renal pelvis, rectal, and melanoma associated with duration of pioglitazone. The duration of pioglitazone was categorized as <12 months, 12-23 months, 24-35 months, 36-59 months, 60+ months.|15 years 5 months|Analysis population included T2DM participants who were identified from the KPNC Diabetes Registry in the study 1. The unexposed arm was not planned to be analyzed for this outcome measure.||Cases|||Number
636586|NCT02540850|Secondary|NPV (the Negative Predictive Value of mSEPT9 Assay in the Population)|the ratio of true negative in all negative cases|1 year|||percentage of true negs in all neg cases|||Number
633847|NCT02958956|Secondary|Hazard Ratio of the 10 Most Common Cancers Associated With Duration of Pioglitazone|The hazard ratio of the 10 most common cancers: prostate, female breast, lung/bronchus, endometrial, colon, non-Hodgkin lymphoma, pancreas, kidney/renal pelvis, rectal, and melanoma associated with duration of pioglitazone. The duration of pioglitazone was categorized as <12 months, 12-23 months, 24-35 months, 36-59 months, 60+ months. Cox proportional hazards regression modeling was used to provide point and interval estimates of the cumulative duration. In all regression analyses, these measures of exposure to pioglitazone were treated as time-dependent covariates and time since entry into the cohort was the time scale.|15 years 5 months|Analysis population included T2DM participants who were identified from the KPNC Diabetes Registry in the study 1.||Ratio||95% Confidence Interval|Number
633848|NCT02958956|Secondary|Number of 10 Most Common Cancers Cases by Time Since First Use of Pioglitazone|Number of 10 most common cancer cases: prostate, female breast, lung/bronchus, endometrial, colon, non-Hodgkin lymphoma, pancreas, kidney/renal pelvis, rectal, and melanoma associated with time since first use of pioglitazone. Time since initiation of pioglitazone was categorized as <12 months ago, 12-23 months ago, 24-35 months ago, 36-47 months ago, 48-83 months ago and 84+ months ago.|15 years 5 months|Analysis population included T2DM participants who were identified from the KPNC Diabetes Registry in the study 1. The unexposed arm was not planned to be analyzed for this outcome measure.||Cases|||Number
633849|NCT02958956|Secondary|Hazard Ratio of the 10 Most Common Cancers Associated With Time Since First Use of Pioglitazone|The hazard ratio of the 10 most common cancers: prostate, female breast, lung/bronchus, endometrial, colon, non-Hodgkin lymphoma, pancreas, kidney/renal pelvis, rectal, and melanoma associated with time since first use of pioglitazone. The various times since initiation include <12 months ago, 12-23 months ago, 24-35 months ago, 36-47 months ago, 48-83 months ago and 84+ months ago. Cox proportional hazards regression modeling was used to provide point and interval estimates of the time since first use. In all regression analyses, these measures of exposure to pioglitazone were treated as time-dependent covariates and time since entry into the cohort was the time scale.|15 years 5 months|Analysis population included T2DM participants who were identified from the KPNC Diabetes Registry in the study 1.||Ratio||95% Confidence Interval|Number
633850|NCT02958956|Primary|Number of 10 Most Common Cancers Associated Cases|Number of 10 most common cancer cases are reported in this measure: prostate, female breast, lung/bronchus, endometrial, colon, non-Hodgkin lymphoma, pancreas, kidney/renal pelvis, rectal, and melanoma.|15 years 5 months|Analysis population included T2DM participants who were identified from the KPNC Diabetes Registry in the study 1.||Cases|||Number
633851|NCT02958956|Primary|Hazard Ratio of the 10 Most Common Cancers Associated With Ever Use of Pioglitazone|The hazard ratio of the 10 most common cancers: prostate, female breast, lung/bronchus, endometrial, colon, non-Hodgkin lymphoma, pancreas, kidney/renal pelvis, rectal, and melanoma associated with ever use of pioglitazone. Cox proportional hazards regression modeling was used to provide point and interval estimates of the relative hazard of the 10 most common cancers associated with ever use of pioglitazone. In all regression analyses, these measures of exposure to pioglitazone were treated as time-dependent covariates and time since entry into the cohort was the time scale.|15 years 5 months|Analysis population included T2DM participants who were identified from the KPNC Diabetes Registry in the study 1.||Ratio||95% Confidence Interval|Number
633852|NCT02958345|Secondary|GPELISA, VZV Glycoprotein Enzyme-Linked Immunosorbent Assay (Aka Varicella Zoster Antibody Titre)|Change in pre and post vaccination Varicella Zoster Virus|Day 1 and 6 weeks|Data was not available for analysis due to laboratory processing error.|||||
633853|NCT02958345|Primary|ELISPOT, Interferon-G Enzyme-Linked Immunospot Assay|Change in vitro cell-mediated immune response to varicella virus before and after vaccination in subjects receiving Zostavax™ versus those receiving placebo.|Day 1 and 6 weeks|Data was not available for analysis due to laboratory processing error.|||||
633854|NCT02951767|Secondary|Percentage of Participants Positive for Anti-therapeutic Antibodies (ATA) to Atezolizumab||Day 1 of all cycles (Cycle length = 21 days) and at treatment discontinuation (data cutoff date 04 July 2016, up to maximum length of follow-up of 23.52 months)|Cohort 1 Safety Evaluable Population. Here, number of participants analyzed = participants for whom ATA samples were available.||percentage of participants|||Number
633855|NCT02951767|Secondary|Minimum Serum Concentration (Cmin) of Atezolizumab||Pre-dose (0 hours) on Day 1 of Cycles 1, 2, 3, 4, 8 (Cycle length = 21 days)|Cohort 1 PK evaluable population. Here, number of participants analyzed = participants who were evaluable for this outcome. “n” = participants who were evaluable at specified timepoint.||mcg/mL||Standard Deviation|Mean
633856|NCT02951767|Secondary|Maximum Serum Concentration (Cmax) of Atezolizumab||Pre-dose (0 hours) and 30 minutes post-dose on Day 1 of Cycle 1 (Cycle length = 21 days)|Cohort 1 pharmacokinetic (PK) evaluable population was defined as participants who received any dose of atezolizumab treatment and had PK data at timepoints that were sufficient to determine PK parameters. Here, number of participants analyzed = participants who were evaluable for this outcome.||microgram(s)/milliliter (mcg/mL)||Standard Deviation|Mean
633857|NCT02951767|Secondary|Percentage of Participants Alive at 1-year||1-year|Cohort 1 ITT population.||percentage of participants||95% Confidence Interval|Number
633858|NCT02951767|Secondary|Overall Survival (OS)|OS was defined as the time from start of treatment to the time of death from any cause on study.|Baseline until death (data cutoff date 04 July 2016, up to maximum length of follow-up of 23.52 months)|Cohort 1 ITT population.||months||95% Confidence Interval|Median
633859|NCT02951767|Secondary|Percentage of Participants Who Died|The percentage of participants who died from any cause was reported.|Baseline until death (data cutoff date 04 July 2016, up to maximum length of follow-up of 23.52 months)|Cohort 1 ITT population.||percentage of participants|||Number
633886|NCT02919657|Primary|Weekly Blood Draws to Measure Blood Protein Levels|"Each week the 20 participants will have blood drawn to measure their blood protein levels.
Each participant was required to give blood weekly to determine the blood protein levels. The results show the average over each six week period of testing for each row. Each participant was examined to see if they achieved the average range as set fourth by the dieticians of greater than 6.1 and less than 8.7 within a 10% variable as acceptable.
10 Participants will be given Genepro Gen2 for the first six weeks of the study and whey protein for the final 6.
10 Participants will be given when protein for the first six weeks of the study and Genepro Gen2 for the final 6.
These measurements will read in g/dl"|6 weeks per intervention|||grams per deciliter||Standard Deviation|Mean
639955|NCT02368314|Secondary|Frequency of Heparin Induced Thrombocytopenia||During the treatment period (14 days)||||||
633860|NCT02951767|Secondary|Percentage of Participants With a Confirmed Objective Response of CR or PR as Assessed by the Investigator According RECIST v1.1|Tumor response was assessed by the investigator according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. The percentage of participants with a confirmed objective response of CR or PR was reported. The exact 95% CI was calculated using the Clopper-Pearson method.|Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 23.52 months)|Cohort 1 objective response-evaluable population.||percentage of participants||95% Confidence Interval|Number
633861|NCT02951767|Secondary|PFS as Assessed by the Investigator According to RECIST v1.1|PFS was defined as the time from start of treatment to the first event of death or PD. Tumor response was assessed by the investigator according to RECIST v1.1. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.|Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 23.52 months)|Cohort 1 ITT population.||months||95% Confidence Interval|Median
633862|NCT02951767|Secondary|Percentage of Participants With Death or Disease Progression as Assessed by the Investigator According to RECIST v1.1|Tumor response was assessed by the investigator according to RECIST v1.1. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The percentage of participants who died or experienced PD was reported.|Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 23.52 months)|Cohort 1 ITT population.||percentage of participants|||Number
633863|NCT02951767|Secondary|Progression-Free Survival (PFS) as Assessed by the IRF According to RECIST v1.1|PFS was defined as the time from start of treatment to the first event of death or PD. Tumor response was assessed by the IRF according to RECIST v1.1. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.|Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 23.52 months)|Cohort 1 ITT population.||months||95% Confidence Interval|Median
633864|NCT02951767|Secondary|Percentage of Participants With Death or Disease Progression as Assessed by the IRF According to RECIST v1.1|Tumor response was assessed by the IRF according to RECIST v1.1. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.|Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 23.52 months)|Cohort 1 ITT population.||percentage of participants|||Number
633865|NCT02951767|Secondary|DOR as Assessed by the Investigator According to RECIST v1.1|DOR was defined as the time from the initial occurrence of documented CR or PR (whichever occurred first) until documented disease progression or death due to any cause on study, whichever occurred first. Tumor response was assessed by the investigator according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and no new measurable or unmeasurable lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to Baseline sum LD.|Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 23.52 months)|Cohort 1 objective response-evaluable population. Here, number of participants analyzed = participants who were evaluable for this outcome.||months||Full Range|Median
633866|NCT02951767|Secondary|Duration of Response (DOR) as Assessed by the IRF According to RECIST v1.1|DOR was defined as the time from the initial occurrence of documented CR or PR (whichever occurred first) until documented disease progression or death due to any cause on study, whichever occurred first. Tumor response was assessed by the IRF according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR.|Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 23.52 months)|Cohort 1 objective response-evaluable population. Here, number of participants analyzed = participants who were evaluable for this outcome.||months||Full Range|Median
633887|NCT02912650|Other Pre-specified|Participant's Global Evaluation of Study Medication|Participant global evaluation of study medication was performed at the 12-hour time point or immediately before taking the rescue medication. It was scored on a 6-point categorical scale where 0= Very poor, 1= Poor, 2= Fair, 3= Good, 4= Very Good and 5= Excellent.|0 to 12 hours post-dose|FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.||units on a scale||Standard Deviation|Mean
633968|NCT02856880|Primary|Area Under the Curve for Glycolysis (AUCgly(0-90)) of Test Zinc-IPMP and Non-SLS Negative Control|AUCgly(0-90) of Test zinc-IPMP and non-SLS negative control was calculated using trapezoidal method.|Baseline up to 90 minutes (min)|The Per Protocol (PP) population defined as those participants in the intent to treat (ITT) population who had at least one assessment of efficacy considered unaffected by protocol violation.||plaque incubation pH*min||Standard Error|Least Squares Mean
633867|NCT02951767|Primary|Percentage of Participants With a Confirmed Objective Response of Complete Response (CR) or Partial Response (PR) as Assessed by the Independent Review Facility (IRF) According to RECIST v1.1|Tumor response was assessed by the IRF according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeters (mm). PR was defined as greater than or equal to (≥) 30 percent (%) decrease in sum of longest diameter (LD) of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. The percentage of participants with a confirmed objective response of CR or PR was reported. The exact 95% confidence interval (CI) was calculated using the Clopper-Pearson method.|Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 23.52 months)|Cohort 1 objective response-evaluable population included intent-to-treat (ITT) participants who had measurable disease per RECIST v1.1 at baseline. Cohort 1 ITT population included all participants from Cohort 1 who received any amount of study drug.||percentage of participants||95% Confidence Interval|Number
633868|NCT02949141|Primary|Diagnosis of Pneumonia|Sensitivity and specificity of ultrasound compared to chest x-ray for the diagnosis of pneumonia using Chest CT as the gold standard for diagnosis.|9 months|62||Participants|||Count of Participants
633869|NCT02947984|Secondary|Local Failure Rate|The number of participants with local failure. Local failure is defined as radiologic progression seen on follow-up scans showing tumor margin(s) extending in any direction at least five mm beyond that seen on baseline scans.|15 Years|Failure rates are shown by dose group in the overall study population and by treatment indication subgroups.||participants|||Number
633870|NCT02947984|Secondary|Late Toxicities|The number of participants that experienced the specified late toxicities (any grade) as assessed by Radiation Therapy Oncology Group Late Effects Scale.|5 Years|||participants|||Number
633871|NCT02947984|Secondary|Acute Toxicities|The number of participants that experienced the specified acute toxicities (any grade) as assessed by Radiation Therapy Oncology Acute Morbidity Scoring Criteria. Acute toxicities were assessed from the start of treatment through day 90 of treatment.|90 Days|||participants|||Number
633872|NCT02947984|Primary|Progression Free Survival|The number of participants surviving at the given time point. Progression free survival (PFS) is measured from the starting date of radiation therapy and analyzed by intention to treat. PFS is measured until the earlier, date of death or development of radiologic progression, and is otherwise censored at the last follow-up for progression-free patients still alive.|5, 10, 15 years|Progression free survival in the entire cohort and by radiation indication sub-groups||percentage of participants surviving||95% Confidence Interval|Number
633873|NCT02941640|Secondary|Hospital Stay|Length of hospitalization|30 days|||days||Standard Deviation|Median
633874|NCT02941640|Secondary|Time of Application|Time of application of endoloop, stapler, Hem-o-lok and DS clip measured from introducing of instruments to cutting the base of appendix|120 min|||seconds||Standard Deviation|Mean
633875|NCT02941640|Secondary|Operative Time|Time of operative procedure|120 min.|||minutes||Standard Deviation|Mean
633876|NCT02941640|Secondary|Postoperative Complications|Complications that appear after operative procedure|30 days|||Participants|||Count of Participants
633877|NCT02941640|Secondary|Intra-perative Complications|Complications that appear during operative procedure|120 min.|||Participants|||Count of Participants
633878|NCT02941640|Primary|Overall Morbidity|Overall morbidity following the securing of the base of the appendix, defined as any adverse event occurring from the time of securing the base of the appendix until the 30th day.|30 days|||Participants|||Count of Participants
633879|NCT02937506|Primary|Patient Satisfaction|Satisfaction assessed using self-developed questionnaire.|Patient satisfaction was assessed the day of the procedure.|Same as enrolled.||Participants|||Count of Participants
633880|NCT02934347|Secondary|The Time Between the Beginning of Laryngoscopy and Detection of Carbon Dioxide on the End-tidal Carbon Dioxide Monitor|The time between the beginning of laryngoscopy and detection of carbon dioxide on the end-tidal carbon dioxide monitor after the successful placement of the tracheal tube was recorded|Once at intubation|Adult patients who required intubation as part of their routine anaesthesia||seconds||Inter-Quartile Range|Median
633881|NCT02934347|Secondary|The Use of Ancillary Equipment|The use of ancillary equipment (e.g. bougie, alternative laryngoscope blades) and manoeuvres (e.g. laryngeal manipulation) were recorded but applied at the intubating anaesthetist’s discretion|Once at intubation|Adult patients who required intubation as part of their routine anaesthesia||participants|||Number
633882|NCT02934347|Secondary|The Number of Attempts at Both Laryngoscopy and Tracheal Intubation|The number of attempts at both laryngoscopy and tracheal intubation were recorded|Once at intubation|Adult patients who required intubation as part of their routine anaesthesia||participants|||Number
633883|NCT02934347|Primary|The Best Glottic View Obtained During Laryngoscopy|"The best glottic view obtained during laryngoscopy was assessed using the Cormack and Lehane classification by the anaesthetist performing the laryngoscopy.
The Cormack and Lehane classifies glottic views as follows: Grade 1: Most of the glottis is visible, Grade 2: At best almost half of the glottis is seen, at worst only the posterior tip of the arytenoids is seen., Grade 3: Only the epiglottis is visible, Grade 4: No laryngeal structures are visible."|The view of the glottis was measured once while the patient was being intubated|Adult patients who required intubation as part of their routine anaesthesia||participants|||Number
633884|NCT02920749|Secondary|Costs of Anaesthesia|total cost of drugs (midazolam, propofol 1%, sevoflurane, atracurium, diclofenac, nalbuphin and antidotes) and disposable cost in euros|1 hour|||euros|total cost of anaesthesia|Standard Deviation|Mean
633885|NCT02920749|Primary|Drug Consumption|drugs of sevoflurane or total intravenous anaesthesia without or with BIS and TOF monitoring : fentanyl, sevoflurane, propofol 1%, atracurium in milligrams|at induction one dose and during anaesthesia mg/1 hour|||mg||Standard Deviation|Mean
633991|NCT02849678|Secondary|Time to First Flatus/Defecation|During the hospitalization following surgery until discharge. Hospital length of stay ranged from 3 - 22 days following surgery.|During the inpatient hospitalization (Hospital length of stay ranged from 3 - 22 days following surgery)||||||
639956|NCT02368314|Secondary|Frequency of All Bleedings||During the treatment period (14 days)||||||
633888|NCT02912650|Other Pre-specified|Cumulative Percentage of Participants With Meaningful Relief|"Percentage of participants with meaningful relief was reported. Participants evaluated time to meaningful relief by stopping a second stopwatch labeled meaningful relief at the moment they first began to experience meaningful relief. Stopwatch was active up to 12 hours after dosing or until stopped by participant, or participant became treatment failure prior to depressing the second stopwatch. Treatment failure was defined as participant taking rescue medication, or discontinuing due to lack of efficacy."|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose|FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.||percentage of participants|||Number
633889|NCT02912650|Other Pre-specified|Cumulative Percentage of Participants With Confirmed First Perceptible Relief|Percentage of participants with confirmed first perceptible relief was reported. Participants evaluated the time to first perceptible relief (confirmed by meaningful relief) by stopping the first stopwatch labelled 'first perceptible relief' at the moment they first began to experience any pain relief, if the participant also achieved meaningful relief by the end of the study. Stopwatch was active up to 12 hours after dosing or until stopped by the participant, or until the participant dropped out due to treatment failure prior to depressing the first stopwatch or until the time of withdrawal (discontinuation). Treatment failure was defined as participant taking rescue medication, or discontinuing due to lack of efficacy.|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose|FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.||percentage of participants|||Number
633890|NCT02912650|Other Pre-specified|Cumulative Percentage of Participants With Treatment Failure|Treatment failure was defined as taking the rescue medication or discontinuation of the participants from the study due to lack of efficacy, whichever came first. Participants were censored at 12 hours or at their final assessment time, whichever came first. Percentage of participants who had treatment failure were reported.|1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose|FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.||percentage of participants|||Number
633891|NCT02912650|Other Pre-specified|Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference Scores on 4-Point Categorical Scale (SPRID4) Over 2, 6, 8, 12 and 6 to 8 Hours Post-dose|SPRID4: Time-weighted sum of PRR and PID based on 4 point categorical pain severity rating scale (PRID) with score range: -2(worst score) to 14 (best score) for SPRID 0-2, -6 (worst score) to 42 (best score) for SPRID 0-6, -8 (worst score) to 56 (best score) for SPRID 0-8, -12 (worst score) to 84 (best score) for SPRID 0-12 and -3 (worst score) to 21 (best score) for SPRID 6-8 hours. PRID: sum of PID and PRR at post-dose time point with score range: -1 (worst score) to 7 (best score). PID calculated by subtracting pain intensity score at post-dose time points (score range: 0 [none] to 3 [severe]) from baseline pain intensity scores (score range: 2 =moderate pain to 3 = severe pain; as participants with baseline score of at least moderate were included). PID total possible score range: -1 (worst score) to 3(best score). PRR assessed on 5-point categorical scale with range: 0 =no relief to 4 =complete relief.|0 to 2 hours, 0 to 6 hours, 0 to 8 hours, 0 to 12, 6 to 8 hours post-dose|FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.||units on a scale||Standard Deviation|Mean
633892|NCT02912650|Other Pre-specified|Time-weighted Sum of Pain Relief Rating (TOTPAR) From 0 to 2 Hours, 0 to 6 Hours and 0 to 12 Hours Post Dose|TOTPAR: Time-weighted sum of PRR scores over 2, 6 and 12 hours. TOTPAR total score range: 0 (worst score) to 8 (best score) for TOTPAR 0-2, 0 (worst score) to 24 (best score) for TOTPAR 0-6, 0 (worst score) to 32 (best score) for TOTPAR 0-8, 0 (worst score) to 48 (best score) for TOTPAR 0-12. PRR was assessed on a 5-point categorical pain relief rating scale which ranges from 0 =no relief to 4 =complete relief.|0 to 2 hours, 0 to 6 hours, 0 to 12 hours post-dose|FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.||units on a scale||Standard Deviation|Mean
633893|NCT02912650|Other Pre-specified|Time-weighted Sum of Pain Intensity Difference Scores on 4-Point Categorical Scale (SPID4) From 0 to 2 Hours, 0 to 6 Hours, 0 to 8 Hours, 0 to 12 Hours and 6 to 8 Hours Post-dose|Pain intensity was assessed on a 4-point categorical pain severity rating scale. SPID4: Time-weighted sum of PID over post-dose time points. SPID4 score range was -2 (worst score) to 6 (best score) for SPID 0-2, -6 (worst score) to 18 (best score) for SPID 0-6, -8 (worst score) to 24 (best score) for SPID 0-8, -12 (worst score) to 36 (best score) for SPID 0-12 and -3 (worst score) to 9 (best score) for SPID 6-8. PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 [none] to 3 [severe]) from the baseline pain intensity scores (score range: 2 =moderate pain to 3 = severe pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID: -1 (worst score) to 3 (best score).|0 to 2 hours, 0 to 6 hours, 0 to 8 hours, 0 to 12, 6 to 8 hours post-dose|FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.||units on a scale||Standard Deviation|Mean
633894|NCT02912650|Other Pre-specified|Time-weighted Sum of Pain Intensity Difference Scores on 11-Point Numerical Scale (SPID11) From 0 to 2 Hours, 0 to 6 Hours and 0 to 12 Hours Post-dose|Pain intensity was assessed on an 11-point numerical pain severity rating scale. SPID11: Time-weighted sum of PID scores over 12 hours. SPID11 score range was -10 (worst score) to 20 (best score) for SPID 0-2, -30 (worst score) to 60 (best score) for SPID 0-6, -60 (worst score) to 120 (best score) for SPID 0-12. PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 =no pain to 10 =worst possible pain) from the baseline pain intensity scores (score range: 5 =moderate pain to 10 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID: -5 (worst) to 10 (best).|0 to 2 hours, 0 to 6 hours, 0 to 12 hours post-dose|FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.||units on a scale||Standard Deviation|Mean
633921|NCT02886338|Primary|to Assess the Commpleteness of of Capsule Endoscopy|To evaluate the completeness of capsule endoscopic examination, visualization of the mucosa of esophagus, stomach and duodenum was analyzed separately during and after the capule endoscopic examination by real time image and capsule video images. We estimated the percentage of mucosa that could be clearly examined with a 5-point assessment scale (0%, 25%, 50%, 75% and 100% of the visibility of the mucosa of esophagus, stomach, and duodenum)|The outcome measure was performed within 2 weeks after examination|Subjectives had completed the magnetic capsule examination||percentage of mucosa visibility||Full Range|Mean
633895|NCT02912650|Other Pre-specified|Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4)|PRID4: sum of PID and PRR at each post-dose time points up to 12 hours. Score range for PRID: -1(worst score) to 7(best score). PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 [no pain] to 3 [worst possible pain]) from the baseline pain intensity scores (score range: 2 =moderate pain to 3 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID4: -1 (worst score) to 3 (best score). PRR was assessed on a 5-point categorical pain relief rating scale which ranges from 0 =no relief to 4 =complete relief.|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose|FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.||units on a scale||Standard Deviation|Mean
633896|NCT02912650|Other Pre-specified|Pain Intensity Difference on 4-Point Categorical Scale (PID4)|PID4: baseline pain severity score minus pain severity score at a given time point. Pain intensity was assessed on a 4-point categorical pain severity rating scale. PID4 was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 [no pain] to 3 [worst possible pain]) from the baseline pain intensity scores (score range: 2 =moderate pain to 3 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID4: -1 (worst score) to 3 (best score).|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose|FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.||units on a scale||Standard Deviation|Mean
633897|NCT02912650|Other Pre-specified|Pain Intensity Difference on 11-Point Numerical Scale (PID11)|PID11: baseline pain severity score minus pain severity score at a given time point. Pain intensity was assessed on an 11-point numerical pain severity rating scale. PID11 was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 =no pain to 10 =worst possible pain) from the baseline pain intensity scores (score range: 5 =moderate pain to 10 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID11: -5 (worst score) to 10 (best score).|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose|FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.||units on a scale||Standard Deviation|Mean
633898|NCT02912650|Other Pre-specified|Pain Relief Rating (PRR) Score|"Participants answered a question: “how much relief do you have from your starting pain? on a 5-point categorical pain relief rating scale. Scale ranges from 0= no relief to 4= complete relief."|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose|FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.||units on a scale||Standard Deviation|Mean
633899|NCT02912650|Other Pre-specified|Time to Confirmed Onset of First Perceptible Relief|Participants evaluated the time to first perceptible relief (confirmed by meaningful relief) by stopping the first stopwatch labeled 'first perceptible relief' at the moment they first began to experience any pain relief, if the participant also achieved meaningful relief by the end of the study. Stopwatch was active up to 12 hours after dosing or until stopped by the participant, or until the participant dropped out due to treatment failure prior to depressing the first stopwatch or until the time of withdrawal (discontinuation). Treatment failure was defined as participant taking rescue medication, or discontinuing due to lack of efficacy.|0 to 12 hours post-dose|"FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment. Here, number of participants analyzed signifies those participants who had the event (first perceptiblre relief)."||minutes||95% Confidence Interval|Median
633900|NCT02912650|Secondary|Time to Onset of Meaningful Pain Relief|"Participants evaluated time to meaningful relief by stopping a second stopwatch labelled as meaningful relief at the moment they first began to experience meaningful relief. Stopwatch was active up to 12 hours after dosing or until stopped by participant, or participant became treatment failure prior to depressing the second stopwatch. Treatment failure was defined as participant taking rescue medication, or discontinuing due to lack of efficacy."|0 to 12 hours post-dose|"FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment. Here, number of participants analyzed signifies those participants who had the event (meaningful pain relief)."||minutes||95% Confidence Interval|Median
633901|NCT02912650|Secondary|Cumulative Percentage of Participants With Treatment Failure at 6 and 8 Hours|Treatment failure was defined as taking the rescue medication or discontinuation of the participants from the study due to lack of efficacy, whichever came first. Participants were censored at 12 hours or at their final assessment time, whichever came first. Percentage of participants who had treatment failure were reported.|6 hours, 8 hours post-dose|FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.||percentage of participants|||Number
633902|NCT02912650|Secondary|Time to Treatment Failure|Time to treatment failure was defined as the time interval from the study drug administration up to the first documentation of treatment failure. Treatment failure was defined as taking the rescue medication or discontinuation of the participants from the study due to lack of efficacy, whichever came first. Participants were censored at 12 hours or at their final assessment time, whichever came first.|0 to 12 hours post-dose|FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.||minutes||95% Confidence Interval|Median
633903|NCT02912650|Secondary|Time-weighted Sum of Pain Relief Rating (TOTPAR) From 0 to 8 Hours and 6 to 8 Hours Post-dose|TOTPAR: Time-weighted sum of Pain Relief Rating (PRR) scores over 0 to 8 and 6 to 8 hours. TOTPAR total score range: 0 (worst score) to 32 (best score) for TOTPAR 0-8 and 0 (worst score) to 12 (best score) for TOTPAR 6-8 hours. PRR was assessed on a 5-point categorical pain relief rating scale which ranges from 0 =no relief to 4 =complete relief.|0 to 8 hours, 6 to 8 hours post-dose|FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.||units on a scale||Standard Deviation|Mean
633922|NCT02884427|Secondary|Difference of Maximum Grip Strength for Females|The difference in maximum grip strength for females is that value in kilograms obtained between the best score of the first three gripping attempts made before the intervention compared to the best result obtained from the three attempts after the intervention considering only the women of each group. Maximum force difference will express the force changes before and after the participants are exposed to one of the treatments.|Baseline and 1 hours later (1 session of treatment), assessed as up to 1 month.|||Kilograms (Kg)||Standard Deviation|Mean
633904|NCT02912650|Secondary|Time-weighted Sum of Pain Intensity Difference Scores on 11-Point Numerical Scale From 6 to 8 Hours Post-dose (SPID11 [6-8])|Pain intensity was assessed on an 11-point numerical pain severity rating scale. SPID11 (6-8): Time-weighted sum of PID scores over 6 to 8 hours. SPID11 score range was -15 (worst score) to 30 (best score) for SPID 6-8. PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 =no pain to 10 =worst possible pain) from the baseline pain intensity scores (score range: 5 =moderate pain to 10 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID: -5 (worst score) to 10 (best score).|6 to 8 hours post-dose|FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.||units on a scale||Standard Deviation|Mean
633905|NCT02912650|Primary|Time-weighted Sum of Pain Intensity Difference Scores on 11-Point Numerical Scale From 0 to 8 Hours Post-dose (SPID11 [0-8])|Pain intensity was assessed on an 11-point numerical pain severity rating scale. SPID11 (0-8): Time-weighted sum of pain intensity difference (PID) scores over 8 hours. SPID11 score range was -40 (worst score) to 80 (best score) for SPID 0-8. PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 =no pain to 10 =worst possible pain) from the baseline pain intensity scores (score range: 5 =moderate pain to 10 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID: -5 (worst score) to 10 (best score).|0 to 8 hours post-dose|FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.||units on a scale||Standard Deviation|Mean
633906|NCT02910362|Primary|Determine Comparative IOP Stability Between Abbott and Alcon Phacoemulsification Equipment.||intraoperative|||mmHg|eyes|Standard Deviation|Mean
633907|NCT02903238|Secondary|Overall Brain Neocortical Gray Matter Volume||2 weeks|Data were not collected and the Outcome will never be analyzed|||||
633908|NCT02903238|Secondary|WOMAC Pain Index|Osteoarthritis (OA) specific pain and quality of life index (the Western Ontario and McMaster Universities Osteoarthritis Index WOMAC). The WOMAC score is from 0 to 96 where 0 represent no pain and quality of life impairment due to OA and 96 represent the worst pain and quality of life impairment due to OA. The outcome is reported as the percent change from baseline to end of treatment (2 weeks).|2 weeks|||Percent Change in WOMAC score||Standard Deviation|Mean
633909|NCT02903238|Primary|Brain Regional Gray Matter Density|"Gray matter density (GMD) of the prefrontal cortex region identified as placebo biomarker. Placebo responders/non-responders were identified based on the VAS score. A minimum of 20% decrease in VAS score was needed to be qualified as responders.
GMD is a value between 0 and 1 representing the intensity of every brain voxels. The GMD of the prefrontal cortex region represent the average GMD of every voxels in this region."|2 weeks|||Gray Matter Density: 0 to 1||Standard Deviation|Mean
633910|NCT02895347|Primary|Amount of Time to Achieve Proficiency|time, measured in minutes, it took each participant in the intervention group to achieve surgical proficiency on the robotic simulator.|assessed after the orientation and prior to the three week date for the final suturing assessment|||minutes||Full Range|Mean
633911|NCT02895347|Primary|Amount Time to Suture|time, measured in minutes, it took each participant to perform the suturing activity|Three weeks after orientation|||minutes||Standard Deviation|Mean
633912|NCT02895347|Primary|Global Evaluative Assessment of Robotic Skills (GEARS) Scale|GEARS is a validated assessment tool for grading overall technical proficiency for robotic surgery. The overall proficiency score is a composite score of five different measures: depth perception, bimanual dexterity, efficiency, force sensitivity, and robotic control. Each of these subscale scores are graded 1-5, with 1 being poor and 5 being excellent. The total score is the summation of the scores from each of the five subscales and ranges from 5 to 25.|Three weeks after orientation|||units on a scale||Standard Deviation|Mean
633913|NCT02891863|Primary|Conversion Efficacy of Low Energy VT Therapies|Effectiveness of LEVER Acute Study System low energy therapies to convert MVTs will be collected and tracked as an aggregate success rate (%) on a per-attempt basis for each therapy tested.|Acute - eg within 5 seconds of test therapy delivery|6 of 9 subjects had at least one inducible VT, a total of 14 attempts to convert VT with multiple pulses were delivered and none converted the VT in any subject.||percentage of VF conversion success|Attempts at VF Conversion||Number
633914|NCT02891863|Primary|System and Procedure Related Adverse Events|All system and procedure-related adverse events through 7 days (-1/+3 days) post-procedure will be collected and tracked.|7 days post-procedure|||participants|||Number
633915|NCT02889289|Other Pre-specified|Time in Therapeutic Heart Rate Range (TTR)|TTR is the amount of time the Veteran spends within a target heart range of moderate to vigorous exercise prescribed as greater than 40% heart rate reserve.|(Intervention) 2 times per week for 8 weeks|||Minutes||Standard Deviation|Mean
633916|NCT02889289|Other Pre-specified|Total Activity Time (TAT)|TAT is a measure of the total time that the Veteran will be participating in mini-game challenges during the 60 minute intervention session.|(Intervention) 2 times per week for 8 weeks|||Minutes||Standard Deviation|Mean
633917|NCT02889289|Secondary|Heart Rate at Beginning of Mini-game|Heart rated recorded using heart monitor and chest strap at the beginning of each mini-game.|(Intervention) 2 times per week for 8 weeks|||Heart beats per minute||Standard Deviation|Mean
633918|NCT02889289|Secondary|Heart Rate at End of Mini-game|Heart rated recorded using heart monitor and chest strap at the end of each mini-game.|(Intervention) 2 times per week for 8 weeks|||Heart beats per minute||Standard Deviation|Mean
633919|NCT02889289|Secondary|Limits of Stability (LOS) - Directional Control|The LOS is performed on the NeuroCom Balance Manager. The LOS test is a goal-directed weight shifting task. The LOS-directional control measures the accuracy of an individual's movement of center of gravity during the task compared to a straight line. This is reported as a percentage without units.|(Baseline) Weeks 1,2,3,4,6,13,14; (Intervention) Weeks 1, 3, 4, 6, 8; (Retention) Weeks 1, 2, 3, 4, 5|||percentage of accuracy||Standard Deviation|Median
633920|NCT02889289|Primary|Dynamic Gait Index (DGI)|The DGI is a common clinical measure used to evaluate dynamic balance and coordination during a person’s daily activities. This test was developed by Shumway-Cook and features 8-items which assess a person’s ability to walk while turning their head, changing speed, and navigating obstacles. The DGI is scored from 0 to 24 where higher scores indicate higher dynamic balance function.|Changes from (Baseline) Weeks 1,2,3,4,6,13,14 to (Intervention) Weeks 1, 3, 4, 6, 8 and to (Retention) Weeks 1, 2, 3, 4, 5|||units on a scale||Standard Deviation|Median
633923|NCT02884427|Secondary|Difference of Maximum Grip Strength for Males|The difference in maximum grip strength for males is that value in kilograms obtained between the best score of the first three gripping attempts made before the intervention compared to the best result obtained from the three attempts after the intervention considering only the men of each group. Maximum force difference will express the force changes before and after the participants are exposed to one of the treatments.|Baseline and 1 hours later (1 session of treatment), assessed as up to 1 month.|||Kilograms (Kg)||Inter-Quartile Range|Median
633924|NCT02884427|Primary|Difference of Maximum Grip Strength|The difference in maximum grip strength is that value in kilograms obtained between the best score of the first three gripping attempts made before the intervention compared to the best result obtained from the three attempts after the intervention. The maximum force difference will express the force changes before and after the participants are exposed to one of the treatments.|Baseline and 1 hours later (1 session of treatment), assessed as up to 1 month.|||Kilograms (Kg)||Standard Deviation|Mean
633925|NCT02882152|Secondary|Postoperative Bleeding|Postoperative bleeding volume (ml)|baseline (discharge of post-anesthesia care unit-PACU), 24hs, 48hs, 72 hours|||mL||Standard Deviation|Mean
633926|NCT02882152|Primary|Analgesic Efficacy|Pain with verbal numeric rating scale (VNRS). VNRS has 11 points, from zero to 10 (zero= no pain, 1-3 = mild pain, 4-5 = moderate pain, 7-9 = severe pain, 10 = unbearable pain).|baseline (zero hour: discharge of post-anesthesia care unit-PACU), 24hs, 48hs, 72 hours|||units on a scale||Standard Deviation|Mean
633927|NCT02881658|Secondary|Changes of Musculoskeletal-related Traits Via Measuring Centre of Pressure Excursion Index for Left and Right Foot at Baseline and Week 3|centre of pressure excursion index = CPEI|From baseline to week 3|||Percentage of Change||Inter-Quartile Range|Median
633928|NCT02881658|Secondary|Changes of Musculoskeletal-related Traits Via Measuring 6 Metres Gait Speed at Baseline and Week 3||From baseline to week 3|||percentage of change||Inter-Quartile Range|Median
633929|NCT02881658|Secondary|Changes of Musculoskeletal-related Traits Via Measuring Peak Expiratory Flow Rate at Baseline and Week 3||From baseline to week 3|||percentage of change||Inter-Quartile Range|Median
633930|NCT02881658|Secondary|Changes of Musculoskeletal-related Traits Via Measuring Bio-Impedance at Baseline and Week 3||From baseline to week 3|||percentage of change||Inter-Quartile Range|Median
633931|NCT02881658|Secondary|Changes of Musculoskeletal-related Traits Via Measuring Hand Grip Strength at Baseline and Week 3||From baseline to week 3|||percentage of change||Inter-Quartile Range|Median
633932|NCT02881658|Secondary|Changes of Cardiometabolic Risk Factors Via Measuring Body Temperature at Baseline and Week 3||From baseline to week 3|||percentage of body temperature change||Inter-Quartile Range|Median
633933|NCT02881658|Secondary|Changes of Cardiometabolic Risk Factors Via Measuring Blood Pressure at Baseline and Week 3||From baseline to week 3|||percentage of change||Inter-Quartile Range|Median
633934|NCT02881658|Secondary|Changes of Cardiometabolic Risk Factors Via Measuring Anthropometry at Baseline and Week 3||From baseline to week 3|||percentage of change||Inter-Quartile Range|Median
633935|NCT02881658|Secondary|Changes of Fasting Blood Glucose Via Blood Test at Baseline and Week 3||From baseline to week 3|||percentage of change||Inter-Quartile Range|Median
633936|NCT02881658|Secondary|Change of Serum Creatinine Via Blood Test at Baseline and Week 3||From baseline to week 3|||percentage of change||Inter-Quartile Range|Median
633937|NCT02881658|Secondary|Change of Triglycerides (TAG) Via Blood Test at Baseline and Week 3||From baseline to week 3|||percentage of change||Inter-Quartile Range|Median
633938|NCT02881658|Secondary|Change of Total Cholesterol Via Blood Test at Baseline and Week 3||From baseline to week 3|||percentage of change||Inter-Quartile Range|Median
633939|NCT02881658|Secondary|Change of High-density Lipoprotein Cholesterol (HDL-C) Via Blood Test at Baseline and Week 3||From baseline to week 3|||percentage of change||Inter-Quartile Range|Median
633940|NCT02881658|Secondary|Change of Low Density Lipoprotein Cholesterol (LDL-C) Via Blood Test at Baseline and Week 3||From baseline to week 3|||percentage of change||Inter-Quartile Range|Median
633941|NCT02881658|Primary|Mean of Serum Low-density Lipoprotein Cholesterol (LDL-C) Via Blood Test at Baseline and Week 3||From baseline to week 3|All 201 subjects were included in the population, but certain blood test result on LDL-C were not available, thus difference in the overall number of participants analyzed and the actual number of participants included to present the mean value.||mmol/L||Standard Deviation|Mean
633942|NCT02873429|Secondary|Clinical Global Impression of Change (CGI)|Patient's rating of current symptom level compared to baseline assessment using a five-point bipolar scale: Much better(2), Somewhat better(1), No change(0), Somewhat worse(-1), Much worse(-2)|6-8 weeks|||participants|||Number
633943|NCT02873429|Primary|PROMIS Pain Interference|"Computerized adaptive test measuring interference of pain in everyday functioning using five-point Likert-type scales with two types or response options (i.e., not at all=1, a little bit=2, somewhat=3, quite a bit=4, very much=5, and never=1, rarely=2, sometimes=3, often=4, always=5). Scores on the items are summed to create a raw score. The raw score is converted to a T-score metric in which 50 is the mean of the relevant reference population and 10 is the standard deviation (SD) of that population.(see http://www.healthmeasures.net for details of CAT administration and scoring)."|6-8 weeks|||T-score metric||Standard Deviation|Mean
633944|NCT02873429|Primary|PROMIS Pain Intensity|PROMIS Pain Intensity is a three item scale measuring the severity of pain at its worst (past week), average (past week), and current level using a five-point Likert-type scale (i.e., no pain=1, mild=2, moderate=3, severe=4, very severe=5). Scores on the 3 items are summed to create a raw score, which can range from 3 to 15. The raw score is converted to a T-score metric in which 50 is the mean of the relevant reference population and 10 is the standard deviation (SD) of that population.(see http://www.healthmeasures.net/promis-scoring-manuals for details ).|6-8 weeks|||T-score metric||Standard Deviation|Mean
633945|NCT02867150|Primary|Fat Reduction in Treatment Zone as Measured in Inches Lost|Circumferential measurement of thighs, hips and waist before and after treatment.|Single 32-minute treatment session|||inch||Full Range|Mean
633946|NCT02863198|Secondary|Pregnancy Rate Between the Study and the Control Group|detection of serum pregnancy tests for both groups( study and the control group)|3 weeks|||participants|||Number
633992|NCT02849678|Secondary|Time to First Ambulation(Walking Greater Than 15 Feet)|During the hospitalization following surgery until discharge. Hospital length of stay ranged from 3 - 22 days following surgery.|During the inpatient hospitalization (Hospital length of stay ranged from 3 - 22 days following surgery)||||||
633947|NCT02863198|Primary|Spiral Artery Doppler Resistance Indices in All Patients|Spiral artery Doppler resistance indices between study and control groups on the day of human chorionic gonadotropin administration.it is an indicator of resistance of Spiral artery to perfusion . In ultrasonography,it can be calculated from the peak systolic velocity and end diastolic velocity of blood flow and is calculated with the following formula: (peak systolic velocity – end diastolic velocity)/peak systolic velocity.lower values are better than higher values.|one week|||index||Standard Deviation|Mean
633948|NCT02863198|Primary|Spiral Artery Pulsatility Indices in All Patients|Spiral artery Doppler pulsatility indices between study and control groups on the day of human chorionic gonadotropin administration.Pulsatility index is a measure of the variability of blood velocity in a vessel, and was calculated as the difference between the peak systolic and end diastolic velocities divided by the mean velocity during the cardiac cycle. Higher values are indicative of increased vascular resistance|one week|||index||Standard Deviation|Mean
633949|NCT02863198|Primary|Appearance of Sub Endometrial Blood Flow in All Patients|Appearance of sub endometrial blood flow between patients of study and control groups on the day of human chorionic gonadotropin administration. subendometrial blood flow distribution pattern was determined by demonstrating pulsatile color signals in the sub endometrial area.The number of patients demonstrating subendometrial blood flow distribution pattern are collected .|one week|||participants|||Number
633950|NCT02863198|Primary|Measurement of Uterine Artery Resistance Index|measurement of uterine artery resistance index at day of human chorionic gonadotropin administration.it is an indicator of resistance of uterine artery to perfusion . In ultrasonography, it can be calculated from the peak systolic velocity and end diastolic velocity of blood flow and is calculated with the following formula: (peak systolic velocity – end diastolic velocity)/peak systolic velocity.lower values are better than higher values.|one week|||index||Standard Deviation|Mean
633951|NCT02863198|Primary|Measurement of Uterine Artery Pulsatility Index|measurement of uterine artery pulsatility index at day of human chorionic gonadotropin administration.Pulsatility index is a measure of the variability of blood velocity in a vessel, and was calculated as the difference between the peak systolic and end diastolic velocities divided by the mean velocity during the cardiac cycle. Higher values are indicative of increased vascular resistance.|one week|||index||Standard Deviation|Mean
633952|NCT02862600|Secondary|Change From Baseline in the Six-minute Walk Test at the End of Period 1|At the conclusion of 8 weeks of perhexiline treatment, 6MWD was measured and compared to 6MWD measured at baseline.|end of Period 1 (Week 8)|||meters||Standard Deviation|Mean
633953|NCT02862600|Secondary|Change From Baseline in the Six-minute Walk Test at the End of Period 2|At the conclusion of 16 weeks of perhexiline treatment, 6MWD was measured and compared to 6MWD measured at baseline.|end of Period 2 (Week 16)|||meters||Standard Deviation|Mean
633954|NCT02862600|Secondary|Change From Baseline of VO2MAX at End of Period 1|At the conclusion of 8 weeks of perhexiline treatment, MVO2 was measured using CPEX and compared to MVO2 measured at baseline.|end of Period 1 (Week 8)|||ml/kg/min||Standard Deviation|Mean
633955|NCT02862600|Primary|Change From Baseline of VO2MAX at 16 Weeks|At the conclusion of 16 weeks of perhexiline treatment, MVO2 was measured using CPEX and compared to MVO2 measured at baseline.|end of Period 2 (Week 16)|||ml/kg/min||Standard Deviation|Mean
633956|NCT02862106|Secondary|Change From Baseline by Vsit for HBeAg Titer.|Measuring the change in value of each visit viewpoints HBeAg titers decreased compared with baseline values|week95,108,120,144|intend to treat population||IU/ML||Standard Deviation|Mean
633957|NCT02862106|Secondary|Percentage of Participants Who Achieved HBV DNA Levels <29300 IU/mL or HBV DNA Load Decrease Equal or Greater Than 2 Log Scales;||week95,108,120,144|intent to treat population||percentage of participants|||Number
633958|NCT02862106|Secondary|Change From Baseline by Visit for Serum HBV DNA||week95,108,120,144|intention to treat population||log_10 IU/mL||Standard Deviation|Mean
633959|NCT02862106|Secondary|The Proportion of Patients With HBV DNA Levels Undetectable or Below the Detection Limit||week95,108,120,144|intention to treat population||percentage of participants|||Number
633960|NCT02862106|Secondary|The Proportion of Patients With Both Negative HBsAg and HBsAb.||week95,108,120,144|intent-to-treat population||percentage of participants|||Number
633961|NCT02862106|Secondary|The Proportion of Patients About HBsAg / Anti-HBs Seroconversion at Week 95,108,120,144||week95,108,120,144|intention to treat population||percentage of participants|||Number
633962|NCT02862106|Secondary|The Proportion of Patients With Both Negative HBeAg and HBeAb.||week95,108,120,144|intention to treat population||percentage of paricipants|||Number
633963|NCT02862106|Secondary|The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at week95,108,120,144||week95,108,120,144|Intention to treat population||percentage of paricipant|||Number
633964|NCT02862106|Primary|The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at the End of the Follow-up Period|"Primary endpoint data were summarised under End of Study,using the last available post-baseline observation(Last Observation Carried Forward,LOCF)"|Endpoint (LOCF), up to 144 weeks|Intent-to-treat population||percentage of participants|||Number
633965|NCT02856880|Secondary|AUClive:Dead(0-90) for Test Zinc-IPMP, Test Zinc Non-IPMP, Positive Control, Non-SLS Negative Control and SLS Negative Control|AUClive:dead(0-90) for test zinc-IPMP, test zinc non-IPMP, positive control, non-SLS negative control and SLS negative control was calculated using trapezoidal method.|Baseline up to 90 min|PP population defined as those participants in the ITT population who had at least one assessment of efficacy considered unaffected by protocol violation.||live:dead stain ratio*min||Standard Error|Least Squares Mean
633966|NCT02856880|Secondary|AUCregrowth(0-90) for Test Zinc-IPMP, Test Zinc Non-IPMP, Positive Control, Non-SLS Negative Control and SLS Negative Control|AUCregrowth(0-90) for test zinc-IPMP, test zinc non-IPMP, positive control, non-SLS negative control and SLS negative control was calculated using trapezoidal method.|Baseline up to 90 min|PP population defined as those participants in the ITT population who had at least one assessment of efficacy considered unaffected by protocol violation.||regrowth ratio*min||Standard Error|Least Squares Mean
633967|NCT02856880|Secondary|AUCgly(0-90) for Test Zinc-IPMP, Test Zinc Non-IPMP, Positive Control, Non-SLS Negative Control and SLS Negative Control|AUCgly(0-90) for test zinc-IPMP, test zinc non-IPMP, positive control, non-SLS negative control and SLS negative control was calculated using trapezoidal method.|Baseline up to 90 min|PP population defined as those participants in the ITT population who had at least one assessment of efficacy considered unaffected by protocol violation.||plaque incubation pH*min||Standard Error|Least Squares Mean
633969|NCT02855411|Secondary|Number of Participants With Abnormalities in Physical Examination|A full physical examination includes head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. The brief physical examination is focused on general appearance, the respiratory and cardiovascular systems, as well as towards participant reported symptoms.|Screening up to Week 12 or early termination|Study was terminated before participants were treated and no data was collected for the endpoints.|||||
633970|NCT02855411|Secondary|Number of Participants With Abnormalities in Neurological Examination|The extended neurological examination includes observation for cerebellar (intention) tremor and for non-cerebellar tremors (eg, resting or positional), finger nose, heel shin, Romberg, tandem walking, positional and gaze-evoked nystagmus, reflexes, muscle strength, cranial nerves, sensory function of upper and lower extremities. The brief neurological examination includes an assessment of motor and sensory function, cranial nerves, reflexes, non-cerebellar tremor (eg, resting or positional) and cerebellar function. The assessment of cerebellar function is complemented by the Scale for the Assessment and Rating of Ataxia (SARA), a clinical scale based on a semi-quantitative assessment of cerebellar ataxia on an impairment level.|Screening up to Week 12 or early termination|Study was terminated before participants were treated and no data was collected for the endpoints.|||||
633971|NCT02855411|Secondary|Number of Participants With Potentially Clinically Significant Vital Signs Findings|Vital signs criteria of potential clinical concern: 1) systolic blood pressure <90 millimeters of mercury (mm Hg); 2) change from baseline of systolic blood pressure >=30 mm Hg; 3) diastolic blood pressure <50 mm Hg; 4) change from baseline of diastolic blood pressure >=20 mm Hg; 5) supine pulse rate <40 or >120 beats per minute (bpm); 6) standing pulse rate <40 or >140 bpm.|Screening up to Week 12 or early termination|Study was terminated before participants were treated and no data was collected for the endpoints.|||||
633972|NCT02855411|Secondary|Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings|ECG criteria of potential clinical concern: 1) QRS interval (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization): greater than or equal to (>=) 140 milliseconds (msec), >=50% increase from baseline; 2) PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization): >=300 msec, >=25% increase when baseline is greater than (>) 200 msec or >=50% increase when baseline is less than or equal to (<=) 200 msec; 3) QTcF interval (time from ECG Q wave to the end of the T wave corresponding to electrical systole corrected using Fridericia’s formula): absolute value of 450 to less than (<) 480 msec, 480 to <500 msec, >=500 msec; an increase from baseline of 30 to <60 msec or >=60 msec.|Screening up to Week 12 or early termination|Study was terminated before participants were treated and no data was collected for the endpoints.|||||
633973|NCT02855411|Secondary|Number of Participants With Laboratory Test Abnormalities|Number of participants with laboratory test abnormalities without regard to baseline abnormality is assessed. Laboratory test parameters include hematology, clinical chemistry, urinalysis, follicle stimulating hormone, urine drug screen, and pregnancy test.|Screening up to Week 12 or early termination|Study was terminated before participants were treated and no data was collected for the endpoints.|||||
633974|NCT02855411|Secondary|Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. AEs comprised both SAEs and non-SAEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. All AEs (serious and non-serious) occurring following start of treatment or increasing in severity in any period were to be considered as a treatment emergent AE.|For AEs, the time frame was from taking first dose through and including last visit (28 days after the last dose), up to 113 days. For SAEs, the time frame was from the time that the participant provided informed consent to last visit, up to 143 days.|Study was terminated before participants were treated. No AE data was collected and there were no SAEs reported during the screening phase.|||||
633975|NCT02855411|Secondary|CGI-I (Clinical Global Impression–Improvement) at Week 12|The CGI-I consists of a single 7 point rating score total improvement, regardless of whether or not the change is due entirely to drug treatment. Raters select 1 response based on the following question, “Compared to your patient’s condition at the beginning of treatment, how much has your patient changed?” Scores are: 1=Very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; or 7=Very much worse. For the CGI-I, the participant’s condition at the Day 1 (baseline) visit is the criterion for judging improvement at subsequent visits.|Week 12|Study was terminated before participants were treated and no data was collected for the endpoints.|||||
633976|NCT02855411|Secondary|Change From Baseline in the CGI‑S (Clinical Global Impression–Severity) to Week 12|The CGI­-S consists of a single 7 point rating score of illness severity. Raters select 1 response based on the following question, “Considering your total clinical experience with this particular population, how mentally ill is your patient at this time?” Scores are: 1=Normal, not ill at all; 2=Borderline mentally ill; 3=Mildly ill; 4=Moderately ill; 5=Markedly ill; 6=Severely ill; or 7=Among the most severely ill participants.|Baseline, Week 2, Week 6, Week 12|Study was terminated before participants were treated and no data was collected for the endpoints.|||||
633977|NCT02855411|Secondary|Change From Baseline in the SCI‑PANSS Positive, Negative and General Psychopathology Subscales to Week 12|The SCI-­PANSS includes 3 scales and 30 items: 7 items that make up the Positive Scale; 7 items that make up the Negative Scale; and 16 items that make up the General Psychopathology Scale. The Subscale scores are the sum of corresponding individual items.|Baseline, Week 2, Week 6, Week 12|Study was terminated before participants were treated and no data was collected for the endpoints.|||||
633978|NCT02855411|Secondary|Change From Baseline in the SCI‑PANSS (Structured Clinical Interview Positive and Negative Symptoms Scale) Total to Week 12|The SCI-PANSS includes 3 scales and 30 items: 7 items that make up the Positive Scale; 7 items that make up the Negative Scale; and 16 items that make up the General Psychopathology Scale. The sum of the 30 items is defined as the total score.|Baseline, Week 2, Week 6, Week 12|Study was terminated before participants were treated and no data was collected for the endpoints.|||||
637136|NCT02506309|Primary|Percentage of Participants With Negative Cough Stress Test (CST)|Negative cough stress test one year after incontinence surgery.|one year|||percentage of participants|||Number
633979|NCT02855411|Secondary|Change From Baseline in Each of the 6 Individual MCCB Domain Scores (Excluding MCCB Working Memory) to Week 12|The MCCB is a cognitive battery to assess 7 domains recommended by the MATRICS initiative (ie, working memory, verbal learning, speed of processing, attention/vigilance, visual learning, social cognition, reasoning and problem solving). The MCCB yields scores for individual tests that assess specific cognitive domains as well as a composite score. Scores for the individual tests and the overall composite score for all tests are calculated according to the developers’ recommended scoring algorithms.|Baseline, Week 2, Week 6, Week 12|Study was terminated before participants were treated and no data was collected for the endpoints.|||||
633980|NCT02855411|Secondary|Change From Baseline in MCCB Overall Composite (Including All 7 Domains) to Week 12|The MCCB is a cognitive battery to assess 7 domains recommended by the MATRICS initiative (ie, working memory, verbal learning, speed of processing, attention/vigilance, visual learning, social cognition, reasoning and problem solving). The MCCB yields scores for individual tests that assess specific cognitive domains as well as a composite score. Scores for the individual tests and the overall composite score for all tests are calculated according to the developers’ recommended scoring algorithms.|Baseline, Week 2, Week 6, Week 12|Study was terminated before participants were treated and no data was collected for the endpoints.|||||
633981|NCT02855411|Secondary|Change From Baseline in the MCCB Neurocognitive Composite (Excluding Social Cognition Domain) to Week 12|The MCCB is a cognitive battery to assess 7 domains recommended by the MATRICS initiative (ie, working memory, verbal learning, speed of processing, attention/vigilance, visual learning, social cognition, reasoning and problem solving). The MCCB yields scores for individual tests that assess specific cognitive domains as well as a composite score. Scores for the individual tests and the overall composite score for all tests are calculated according to the developers’ recommended scoring algorithms. The MCCB neurocognitive score contains all of the tests and domains of the MCCB composite score with the exception of social cognition.|Baseline, Week 2, Week 6, Week 12|Study was terminated before participants were treated and no data was collected for the endpoints.|||||
633982|NCT02855411|Secondary|Number of Participants With Categorical Results on the Columbia-Suicide Severity Rating Scale (C-SSRS)|"C-SSRS responses are mapped to the Columbia Classification Algorithm of Suicide Assessment (C-CASA). C-SSRS assesses whether participant experienced following: completed suicide (Category 1); suicide attempt (Category 2) (response of “Yes” on “actual attempt”); preparatory acts toward imminent suicidal behavior (Category 3) (“Yes” on “aborted attempt”, or “interrupted attempt”, or “preparatory acts or behavior”); suicidal ideation (Category 4) (“Yes” on “wish to be dead”, or “non-specific active suicidal thoughts”, or “active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent”); self-injurious behavior, no suicidal intent (Category 7) (“Yes” on “has participant engaged in non-suicidal self-injurious behavior”). Number of participants with Yes response for above mentioned categories was to be assessed."|Baseline, followed by weekly (Weeks 1 throughout 12), and 28 days after last dose|Study was terminated before participants were treated and no data was collected for the endpoints.|||||
633983|NCT02855411|Secondary|Scale for the Assessment and Rating of Ataxia (SARA)|SARA is a clinical scale that is based on a semi­-quantitative assessment of cerebellar ataxia on an impairment level and complements the brief neurological examination. The SARA has 8 items that are related to gait, stance, sitting, speech, finger-chase test, nose-finger test, fast alternating movements and heel-shin test.|Baseline, Week 2, Week 6, Week 12|Study was terminated before participants were treated and no data was collected for the endpoints.|||||
633984|NCT02855411|Primary|Change From Baseline in the UPSA‑VIM (University of California, San Diego [UCSD] Performance Based Skills Assessment – Validation of Intermediate Measures) to Week 12|The UPSA-VIM is a functional capacity measure of 5 general skills that were previously identified as essential to functioning in the community: general organization, finance, social/communications, transportation, and household chores. The UCSD Performance Based Skills Assessment involves role play tasks that are administered as simulations of events that the person might encounter in the community.|Baseline, Week 6, Week 12|Study was terminated before participants were treated and no data was collected for the endpoints.|||||
633985|NCT02855411|Primary|Change From Baseline in the MCCB (MATRICS Consensus Cognitive Battery) Working Memory Domain to Week 12|The MCCB is a cognitive battery to assess 7 domains recommended by the MATRICS initiative (ie, working memory, verbal learning, speed of processing, attention/vigilance, visual learning, social cognition, reasoning and problem solving). The MCCB yields scores for individual tests that assess specific cognitive domains as well as a composite score. Scores for the individual tests and the overall composite score for all tests are calculated according to the developers’ recommended scoring algorithms.|Baseline, Week 2, Week 6, Week 12|Study was terminated before participants were treated and no data was collected for the endpoints.|||||
633986|NCT02850159|Primary|Change of Freezing of Gait Questionnaire (FOG-Q)|Change of a self-assessment scale for evaluating participant freezing of gait (FOG) symptoms after non-invasive brain stimulation (NIBS) for 5 consecutive days ((freezing of gait questionnaire (FOG-Q) after NIBS) - (FOG-Q before NIBS) Minimum score: -5 Maximum score: 0 Lower values represent a better outcome.|Assessed at T0, pre-NIBS at day 1 and T1, immediately after NIBS at day 5|||score||Standard Deviation|Mean
633987|NCT02849678|Secondary|Number of Nerve Block Boluses Will Also be Recorded Daily.|During the hospitalization following surgery until discontinuation of the block or discharge. Hospital length of stay ranged from 3 - 22 days following surgery.|During the inpatient hospitalization (Hospital length of stay ranged from 3 - 22 days following surgery)||||||
633988|NCT02849678|Secondary|Postoperative Opioid Requirements (Milligrams of Dilaudid or Equivalent)|During the hospitalization following surgery until discharge. Hospital length of stay ranged from 3 - 22 days following surgery.|During the inpatient hospitalization (Hospital length of stay ranged from 3 - 22 days following surgery)||||||
633989|NCT02849678|Secondary|Any Complication Including But Not Limited to Pneumonia, Atelectasis, Hypotension, Motor Weakness, Etc.|During the hospitalization following surgery until discharge.|During the inpatient hospitalization (Hospital length of stay ranged from 3 - 22 days following surgery)||||||
633990|NCT02849678|Secondary|Hospital Length of Stay.|During the hospitalization following surgery until discharge. Hospital length of stay ranged from 3 - 22 days following surgery.|During the inpatient hospitalization (Hospital length of stay ranged from 3 - 22 days following surgery)||||||
639957|NCT02368314|Secondary|Frequency of Other “Small” Bleedings||During the treatment period (14 days)||||||
633993|NCT02849678|Primary|11-point Verbal Numerical Rating Scale (NRS) Pain Assessment|The primary outcome of the study is the NRS score for pain at rest at 24 hours. The NRS Pain Assessment requires patients to select a number between 0 - 10 where 0 is no pain and 10 is the worst imaginable pain. Patients pick one whole number on this scale to describe their pain.|24 hours from the end of surgery|Patients undergoing elective laparoscopic bowel surgery with bilateral thoracic paravertebral continuous nerve blocks.||Scores on a scale||Full Range|Median
634003|NCT02847169|Primary|Rotational Recovery in Degrees After 60 Seconds|Rotational recovery measured in degrees after 60 seconds for habitual toric lens assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and at 1 week by slit lamp.|Baseline and 1 week|||degrees||Standard Deviation|Mean
634004|NCT02847169|Primary|Lens Orientation in Primary Position of Gaze|Lens rotation for habitual toric lens assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week with slit lamp by measuring within 10 degrees of the axis mark on the lens relative to the desired 6' o'clock position while the subject looked straight ahead.|Baseline and 1 week|||percentage of participants|||Number
634005|NCT02847169|Primary|Corneal Coverage|Corneal coverage for habitual lenses assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week. (yes=full corneal coverage or no=not full coverage)|Baseline and 1 week|||participants|||Number
634006|NCT02847169|Primary|Overall Stability|Overall lens stability for habitual lenses assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week. Scale 0-4, 0=very poor stability, 4=excellent stability.|Baseline and 1 week|||units on a scale||Standard Deviation|Mean
657565|NCT01920282|Other Pre-specified|Oxidized LDL Concentration||12 weeks||||||
634007|NCT02847169|Primary|Post-blink Movement|Post-blink movement for habitual lenses assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week. Scale 0-4, 0=insufficient, 1=minimal, but acceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement.|Baseline and 1 week|||units on a scale||Standard Deviation|Mean
634008|NCT02847169|Primary|Lens Centration|Lens centration for habitual lenses assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week. (Centered - optimal, decentered slightly, or substantially decentered).|Baseline and 1 week|||percentage of participants|||Number
634009|NCT02847169|Primary|Overall Fit Acceptance|Investigator's preference for lens fit acceptance for habitual lenses assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week. Scale 0-4, 0=should not be worn, 1=borderline but unacceptable, 2= minimally acceptable, early review, 3=not perfect but OK to dispense, 4=perfect|Baseline and 1 week|||units on a scale||Standard Deviation|Mean
634010|NCT02844998|Primary|Intravaginal Ejaculatory Latency Time|Duration determined by the sexual partner with stopwatch method, and <1 minute was considered as PE. (minimum/maximum scores were not possible)|Baseline and 30 Days|||seconds||Standard Deviation|Mean
634011|NCT02844998|Primary|Premature Ejaculation Diagnostic Tool (Total Score)|Premature Ejaculation Diagnostic Tool (PEDT) includes five items; control, frequency, minimal stimulation, distress, and interpersonal difficulty. In this classification tool, equal to or less than scores 8 indicates no PE, scores 9 and 10 indicate possible PE, and scores equal or higher than 11 indicates PE. Total score is between 2 and 22.|Baseline and 30 Days|||scores on a scale||Standard Deviation|Mean
634012|NCT02840916|Secondary|Body Fat Percentage (BFP)|The BFP was assessed by an evaluator who was blinded to the intervention details from the beginning through study completion, up to 3 weeks.|up to 3 weeks|||% of body weight||Standard Deviation|Mean
634013|NCT02840916|Secondary|Waist-to-buttock Ratio (WBR)|The WBR was assessed by an evaluator who was blinded to the intervention details from the beginning through study completion, up to 3 weeks.|up to 3 weeks|||ratio||Standard Deviation|Mean
634014|NCT02840916|Primary|Body Mass Index (BMI)|The BMI was assessed by an evaluator who was blinded to the intervention details from the beginning through study completion, up to 3 weeks, and 3 months after study completion.|up to 3 weeks, 3 months after study completion|||kg/m^2||Standard Deviation|Mean
634015|NCT02839772|Secondary|Amharic Dermatology Life Quality Index (DLQI)|The Amharic version of the DLQI has been validated for use in Ethiopia where Amharic is the official working language. The index is divided into 4 sections covering leisure, work and school, personal relationships and treatment. The maximum score of 30 indicates a high impact on quality of life. The lowest score zero. A reduction in the number indicates an improvement in quality of life. Participants were verbally questioned by the clinic nurse or social worker as most participants were illiterate.|Change from baseline following 3 months of intervention|3 month post intervention data missing from one male participant in the control group.||units on a scale||Standard Deviation|Mean
634016|NCT02839772|Secondary|Change in Largest Foot Circumference|Measured by clinic nurse in centimetres with a disposable tape measure at the point of largest circumference on the foot|Change from baseline following 3 months of intervention|3 month post intervention data missing from one male participant in the control group.One left leg in the control group and one right and one left leg in the experimental group was not affected by podoconiosis so they were not included in the study.||Centimetres|Foot circumference|Standard Deviation|Mean
634017|NCT02839772|Secondary|Change in Largest Lower Leg Circumference|Measured by clinic nurse in centimetres with a disposable tape measure at the point of largest circumference on the foot.|Change from baseline following 3 months of intervention|3 month post intervention data missing from one male participant in the control group.One left leg in the control group and one right and one left leg in the experimental group was not affected by podoconiosis so they were not included in the study.||Centimetres|Legs|Standard Deviation|Mean
634018|NCT02839772|Secondary|Correlation Between Number of Work Days Lost Due to Adenolymphangitis and Number of Wounds|Statistical calculation of the correlation between the number of work days lost in the previous month due to leg pain (adenolymphangitis) and the number of wounds present on the lower leg/foot. Wounds on the lower legs/feet may produce a bad odour.|From baseline monthly for 3 months|3 month post intervention data missing from one male participant in the control group. One leg in the control group and two legs in experimental group were not affected by podoconiosis.Data were pre-specified to be collected and analysed for all participants in a single group.||Spearman's correlation coefficient|||Number
634019|NCT02839772|Secondary|Change in Number of Work Days Lost in Previous Month Due to Adenolymphangitis (ADL)|Verbal questioning of participants by clinic nurse or social worker as to number of work days lost due to severe leg pain (adenolymphangitis). Questioning was used as most participants were illiterate.|Change from baseline following 3 months of intervention|3 month post intervention data missing from one male participant in the control group.One leg in the control group and two legs in experimental group were not affected by podoconiosis.Data were pre-specified to be analysed for all participants as a single group.||Number of work days lost.|||Number
634020|NCT02839772|Secondary|Number of Wounds on Lower Legs/Feet of Participants.|"Observation and count of number of wounds (all breaches of the stratum corneum including areas of fungal infection) on lower legs/feet by clinic nurse.
Breaches in the skin and areas of fungal infection are more likely to occur in those with an impaired skin barrier function.A reduction in the number of wounds indicates an improvement in SBF."|Change from baseline following 3 months of intervention|3 month post intervention data missing from one male participant in the control group. One leg in the control group and two legs in experimental group were not affected by podoconiosis. Data was pre-specified to be analysed for all participants as a single group.||Wounds|Feet/legs||Number
634021|NCT02839772|Secondary|Total Number of All Participants With the Presence of a Bad Odour Emanating From Their Lower Limbs.|Change in the presence of bad odour emanating from wounds on participant's lower legs/feet as determined by clinic nurse. Bad odour results in social stigma and impacts of quality of life.|Change from baseline following 3 months of intervention|3 month post intervention data missing from one male participant in the control group. One leg in the control group and two legs in experimental group were not affected by podoconiosis. Data were pre-specified to be collected and analysed for all participants in a single group.||Participants|||Number
636587|NCT02540850|Secondary|PPV (the Positive Predictive Value of mSEPT9 Assay in the Population)|the ratio of true positive in all positive cases|1 year|||percentage of true pos in all pos cases|||Number
634022|NCT02839772|Secondary|Total Number of Trophic Skin Changes (Mossy Changes) All Participants at Baseline and 4th Visit|Total number of observed trophic changes (mossy eruptions on the skin of the lower legs/feet characteristic of podoconiosis) in all participants by clinic nurse at baseline and at 4th visit. Trophic changes were either present or not present.|Change from baseline following 3 months of intervention|3 month post intervention data missing from one male participant in the control group.One leg in the control group and two legs in experimental group were not affected by podoconiosis. Data were pre-specified to be collected and analysed for all participants in a single group.||Trophic skin changes|||Number
634023|NCT02839772|Secondary|Stage of Podoconiosis in Each Leg of All Participants at Baseline and 4th Visit|Podoconiosis Staging System (1-5) used with 5 the most severe stage. This staging system was specifically designed for those with podoconiosis. Legs with stages 1, 2 or 3 were categorised with mild/moderate disease and those with stages 4,5 with severe disease.|Change from baseline following 3 months of intervention|3 month post intervention data missing from one male participant in the control group. One leg in the control group and two legs in experimental group were not affected by podoconiosis. Data were pre-specified to be collected and analysed for all participants as a single group.||Legs/feet|Legs||Number
634024|NCT02839772|Primary|Change in Stratum Corneum Hydration at Top of Feet|Stratum corneum hydration measured at a specific point on the middle top of the foot with a MoistureMeter (non-invasive probe).This measures skin capacitance in arbitrary units. It is generally recommended that differences or percentage changes are reported rather than absolute values. Increases in stratum corneum hydration indicate a positive effect on skin barrier function.|Change from baseline following 3 months of intervention|3 month post intervention data missing from one male participant in the control group. One left foot in the control group and one left and one right foot in the experimental group were not affected by podoconiosis so they were not included in the study.||Arbitrary units|Feet|Standard Deviation|Mean
634025|NCT02839772|Primary|Change in Stratum Corneum Hydration at Base of Outer Lower Leg|Stratum corneum hydration was measured at the base of the outer lower leg 8 cms above the external malleolus. It was measured with a MoistureMeter (non-invasive probe).This measures skin capacitance in arbitrary units. It is generally recommended that differences or percentage changes are reported rather than absolute values. Increases in stratum corneum hydration indicate a positive effect on skin barrier function.|Change from baseline following 3 months of intervention|3 month data missing from one male participant in control group.One left leg in the control group and one right and one left leg in the experimental group were not affected by podoconiosis so they were not included in the study.||Arbitrary units|Legs|Standard Deviation|Mean
634026|NCT02839772|Primary|Change in Stratum Corneum Hydration (SCH) at Mid-point Outer Lower Leg.|SCH was measured mid-way between the measurement site at the top of the outer leg and the site at the base of the outer lower leg. It was measured with a MoistureMeter (non-invasive probe).This measures skin capacitance in arbitrary units. It is generally recommended that differences or percentage changes are reported rather than absolute values. Increases in stratum corneum hydration indicate a positive effect on skin barrier function.|Change from baseline following 3 months of intervention|3 month post intervention data missing from one male participant in the control group.One left leg in the control group and one right and one left leg in the experimental group were not affected by podoconiosis so they were not included in the study.||Arbitrary units|Legs|Standard Deviation|Mean
634027|NCT02839772|Primary|Change in Stratum Corneum Hydration (SCH) at the Top of Outer Lower Legs|Stratum corneum hydration was measured at a specific point at top of outer lower leg (8cms below the head of the fibula) with a MoistureMeter (non-invasive probe).This measures skin capacitance in arbitrary units. It is generally recommended that differences or percentage changes are reported rather than absolute values. Increases in stratum corneum hydration indicate a positive effect on skin barrier function.|Change from baseline following 3 months of intervention|3 month post intervention data missing from one male participant in control group.One left leg in the control group and one right and one left leg in the experimental group was not affected by podoconiosis so they were not included in the study.||Arbitrary units|Legs|Standard Deviation|Mean
634028|NCT02839772|Primary|Change in TEWL at Top of Feet|"Trans-epidermal water loss (TEWL) was measured with a Vapometer (non- invasive probe) at a specific point on the top of the foot. A reduction in TEWL indicates a positive effect on skin barrier function.It is generally recommended that differences or percentage changes are reported rather than absolute values.
TEWL is the water lost through the skin under non-sweating conditions. It is the major indicator of healthy skin. A reduction in TEWL indicates a positive effect on skin barrier function. It is generally recommended that differences or percentage changes are reported rather than absolute values."|Change from baseline following 3 months of intervention|3 month post intervention data missing from one male participant in control group. One left foot leg in the control group and one right and one left foot in the experimental group was not affected by podoconiosis so they were not included in the study.||g/m2/h|Feet|Standard Deviation|Mean
634029|NCT02839772|Primary|Change in TEWL at Base of Outer Lower Legs|"Trans-epidermal water loss (TEWL) was measured with a Vapometer (non- invasive probe) at a specific point on the outer lower leg 8cms above the external malleolus. A reduction in TEWL indicates a positive effect on skin barrier function.It is generally recommended that differences or percentage changes are reported rather than absolute values.
TEWL is the water lost through the skin under non-sweating conditions. It is the major indicator of healthy skin. A reduction in TEWL indicates a positive effect on skin barrier function. It is generally recommended that differences or percentage changes are reported rather than absolute values."|Change from baseline following 3 months of intervention|3 month post-intervention data was missing from one male participant in control group.One left leg in the control group and one right and one left leg in the experimental group was not affected by podoconiosis so they were not included in the study.||g/m2/h|Legs|Standard Deviation|Mean
634042|NCT02826421|Secondary|Mean Corneal Incision Size After IOL Implantation (UltraSert and Monarch III D)|Post-IOL implantation corneal incision size was measured directly after IOL implantation and reported in millimeters (mm). Minimizing enlargement of incision size during cataract surgery results in less postoperative inflammation, less surgically-induced astigmatism, and more rapid visual and wound rehabilitation. This endpoint was prespecified for the UltraSert preloaded delivery system and the Monarch III D delivery system. Only one eye (study eye) contributed to the analysis.|Day 0, operative day|Full Analysis Set||mm||Standard Error|Mean
637574|NCT02480712|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 12 weeks|Safety Analysis Set||percentage of participants|||Number
634030|NCT02839772|Primary|Change in TEWL at Mid-point Outer Lower Legs|Trans-epidermal water loss (TEWL) was measured with a Vapometer (non- invasive probe) at a specific point on the outer lower leg. This was mid-way between the measurement site at the top of the outer leg and the site at the base of the outer lower leg. TEWL is the water lost through the skin under non-sweating conditions. It is the major indicator of healthy skin. A reduction in TEWL indicates a positive effect on skin barrier function. It is generally recommended that differences or percentage changes are reported rather than absolute values.|Change from baseline following 3 months of intervention|3 month post intervention data missing from one male participant in the control group. One left leg in the control group and one right and one left leg in the experimental group was not affected by podoconiosis so they were not included in the study.||g/m2/h|Legs|Standard Deviation|Mean
634031|NCT02839772|Primary|Change in TEWL at Top of Outer Lower Legs|Trans-epidermal water loss (TEWL) was measured with a Vapometer (non-invasive probe) on the outer lower leg 8 cms below the head of the fibula. TEWL is the water lost through the skin under non-sweating conditions. It is the major indicator of healthy skin. A reduction in TEWL indicates a positive effect on skin barrier function. It is generally recommended that differences or percentage changes are reported rather than absolute values.|Change from baseline following 3 months of intervention|3 month post intervention data was missing from one male participant in the control group. One left leg in the control group and one right and one left leg in the experimental group was not affected by podoconiosis so they were not included in the study.||g/m2/h|Legs|Standard Deviation|Mean
634032|NCT02834624|Secondary|Change in Number of Tracheal Macrophages|measurement of lipid peroxidation in tracheal aspirate samples and cytology of tracheal aspirates.in tracheal aspirate|baseline, 48 hours|||white cells/high-powered field||Standard Deviation|Mean
634033|NCT02834624|Secondary|Presence of Pulmonary Hemorrhage|Significant and Persistent Blood present in the trachea during endotracheal tube suctioning.|intraoperative|This data is unavailable from the research department as it was not collected.|||||
634034|NCT02834624|Primary|Change From Baseline in Blood C-reactive (CRP) Protein|Difference between measurement of CRP at baseline and 48 hours after administration of surfactant|baseline, 48 hours|||mg/dL||Standard Deviation|Mean
634035|NCT02832375|Secondary|Change From Baseline in Tactile Threshold Immediately After Single Use and on Day 3|Tactile threshold was assessed by examiner using a constant pressure probe (Yeaple probe) which allowed application of a known force to the dentin surface from 10 g to an upper threshold of 80g in increments of 10 g. The tactile threshold is the maximum pressure applied at which participant do not report any pain or discomfort. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth.|Baseline, after single use (after 5 minutes) and on Day 3|Analysis for this outcome was conducted on ITT population, defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n=number of participants evaluated at specific time points for each treatment arms respectively.||g||Standard Deviation|Mean
634036|NCT02832375|Secondary|Change From Baseline in Schiff Sensitivity Score After Single Use|Schiff sensitivity score was assessed by examiner as participant’s response to an evaporative (air) stimulus after the stimulation of each individual tooth. Response of participant was scored using Schiff sensitivity scale range of 0-3; 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicates improvement in sensitivity.|Baseline, after single use (after 5 minutes)|Analysis for this outcome was conducted on ITT population, defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. Number of participants analyzed is the ITT Population evaluated post treatment single usage for each treatment arms.||score on a scale||Standard Deviation|Mean
634037|NCT02832375|Primary|Change From Baseline in Schiff Sensitivity Score on Day 3|Schiff sensitivity score was assessed by examiner as participant’s response to an evaporative (air) stimulus after the stimulation of each individual tooth. Response of participant was scored using Schiff sensitivity scale range of 0-3; 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicates improvement in sensitivity.|Baseline, Day 3|Analysis for this outcome was conducted on ITT population, defined as all participants who were randomized, received study treatment at least once & provided at least one post-baseline (post treatment) assessment of efficacy. Number of participants analyzed is number of participants from ITT population evaluated on Day 3.||score on a scale||Standard Deviation|Mean
634038|NCT02829775|Secondary|Number of Participants With Overall Tumor Response|Tumor response was assessed every 6 months using hematological evaluation or any other appropriate diagnostic techniques, as per standard of care practice. The complete response (CR) and partial response (PR) status were recorded from case report form.|Baseline until disease progression, withdrawal or death, whichever occurred earlier (assessed every 6 months up to approximately 3 years)|All participants who were recruited in the study.||participants|||Number
634039|NCT02829775|Primary|Number of Participants With Serious Adverse Events (SAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship to the study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; Initial or prolonged inpatient hospitalization; Life-threatening experience (immediate risk of dying); Persistent or significant disability or incapacity; and congenital anomaly.|Baseline up to approximately 3 years|All participants who were recruited in the study.||participants|||Number
634040|NCT02829463|Primary|Infrapatellar Fat Pad Volume in MRI||collect the data within 24 hours after the subjects did the MRI|||mm^3||Standard Deviation|Mean
634041|NCT02828137|Primary|Index of Microcirculatory Resistance|IMR in low NLR group : 21.94 ± 12.87 IMR in intermediate NLR group : 23.22 ± 12.73 IMR in high NLR group : 32.95 ± 20.60|3 months|||IMR||Standard Deviation|Mean
634043|NCT02826421|Primary|Mean Corneal Incision Size After IOL Implantation (UltraSert, iTec, and iSert)|Post-IOL implantation corneal incision size was measured directly after IOL implantation and reported in millimeters (mm). Minimizing enlargement of incision size during cataract surgery results in less postoperative inflammation, less surgically-induced astigmatism, and more rapid visual and wound rehabilitation. This endpoint was prespecified for the UltraSert, iTec, and iSert preloaded delivery systems. Only one eye (study eye) contributed to the analysis.|Day 0, operative day|Full Analysis Set||mm||Standard Error|Mean
634044|NCT02823080|Other Pre-specified|Resolution of Gastrointestinal Manifestations Determined Prior to Start of Therapy|-severity grades of gastrointestinal manifestations determined at Day -0,Day -3 and Day -6.|0-6 days|||GI manifestations|||Number
634045|NCT02823080|Secondary|Daily Total Leucocytic Count|TLC(x 1ooo cells/ml)|0 -8days.|||1000 cells/ml||Standard Deviation|Mean
634046|NCT02823080|Secondary|Ultrasound Detected Severity Grades of Ascites From Days 0-8|-US detected severity grades of ascites determined at Day -0, Day -3 and Day -8.|0-8 days|||US detected ascitis|||Number
634047|NCT02823080|Secondary|Daily Hematocrits Value|Blood samples were obtained under complete aseptic condition for determination of hematocrits value (Ht%)|0-8 days.|||percentge||Standard Deviation|Mean
634048|NCT02823080|Secondary|Daily Numerical Pain Visual Analogue Scale Score|-All patients were clinically evaluated for the presence of abdominal pain and if present was graduated using a numerical pain visual analogue scale (VAS) with 0 means no pain and 10 means severe intolerable pain .|8 days.|||units on a scale||Standard Deviation|Mean
634049|NCT02823080|Primary|Daily Maximal Ovarian Diameter|MOD (maximal ovarian diameter in mm) were evaluated daily.|8 days|||mm||Standard Deviation|Mean
634050|NCT02823080|Primary|Daily Serum E2 Levels|Serum E2 levels (Serum E2 level in picograms/ml) were evaluated daily.|8 days|||picograms/ml||Standard Deviation|Mean
634051|NCT02822885|Primary|Endometrial Thickness According to Histological Diagnosis|Endometrial Thickness was assessed by measuring the trilaminar halo of the Endometrial Thickness by trans vaginal sonography|2 weeks|"All patients(N=70) were subdivided according to histological diagnosis to A-Benign lesion (N=60)
Endometrial polyp(N=17)
Hyperplasia(N=28)
Non-specific(N=15) B-Malignant lesion(N=10)"||millimeter||Standard Deviation|Mean
634052|NCT02822885|Primary|Uterine Artery Pulsatility Index According to Histological Diagnosis|Pulsatility index is a measure of the variability of blood velocity in a vessel, and was calculated as the difference between the peak systolic and end diastolic velocities divided by the mean velocity during the cardiac cycle. Higher values are indicative of increased vascular resistance|2 weeks|"All patients(N=70) were subdivided according to histological diagnosis to A-Benign lesion (N=60)
Endometrial polyp(N=17)
Hyperplasia(N=28)
Non-specific(N=15) B-Malignant lesion(N=10)"||index||Standard Deviation|Mean
634053|NCT02822885|Primary|Uterine Artery Resistive Index According to Histological Diagnosis|The primary outcome measures is uterine artery resistive index (RI) .In ultrasonography,it can be calculated from the peak systolic velocity and end diastolic velocity of blood flow and is calculated with the following formula: (peak systolic velocity – end diastolic velocity)/peak systolic velocity.lower values are better than higher values.|two weeks|"All patients(N=70) were subdivided according to histological diagnosis to A-Benign lesion (N=60)
Endometrial polyp(N=17)
Hyperplasia(N=28)
Non-specific(N=15) B-Malignant lesion(N=10)"||index||Standard Deviation|Mean
634054|NCT02822885|Primary|Resistive Indices (PI) of Spiral Artery According to Histological Diagnosis|The primary outcome measure is spiral artery resistive index (RI) .In ultrasonography,it can be calculated from the peak systolic velocity and end diastolic velocity of blood flow and is calculated with the following formula: (peak systolic velocity – end diastolic velocity)/peak systolic velocity.lower values are better than higher values.|two weeks|"All patients(N=70) were subdivided according to histological diagnosis to A-Benign lesion (N=60)
Endometrial polyp(N=17)
Hyperplasia(N=28)
Non-specific(N=15) B-Malignant lesion(N=10)"||index||Standard Deviation|Mean
634055|NCT02822885|Primary|Pulsatility Indices (PI) of Spiral Artery According to Histological Diagnosis|Pulsatility index is a measure of the variability of blood velocity in a vessel, and was calculated as the difference between the peak systolic and end diastolic velocities divided by the mean velocity during the cardiac cycle. Higher values are indicative of increased vascular resistance|two weeks|"All patients(N=70) were subdivided according to histological diagnosis to A-Benign lesion (N=60)
Endometrial polyp(N=17)
Hyperplasia(N=28)
Non-specific(N=15) B-Malignant lesion(N=10)"||index||Standard Deviation|Mean
634056|NCT02822287|Secondary|Local Oral Tolerability|Local oral tolerability was assessed by performing oropharyngeal examination as follows: Results of oropharyngeal examination (Normal and abnormal); If abnormal, any signs of lesion on oral mucosa or irritation of oral mucosa.|Day 1 (at screening and end of study)|The Safety Population was defined as all treated subjects, i.e., all subjects who received any dose of study drug. The Safety Population was the primary population for both the primary and secondary endpoint analyses and the safety analysis.||Participants|||Number
634057|NCT02822287|Secondary|Number of Participants With Overall Opinion of Oral Solution|Overall opinion of oral solution was measured by scale: 4 = Excellent; 3 = Good; 2 = Fair; 1 = Poor; 0 = Unacceptable.|1 hour post-dose|The Safety Population was defined as all treated subjects, i.e., all subjects who received any dose of study drug. The Safety Population was the primary population for both the primary and secondary endpoint analyses and the safety analysis.||Number of Participants|||Number
634058|NCT02822287|Secondary|Number of Participants With Overall Opinion of Warming Sensation|Overall opinion of warming sensation was measured by scale: 9= Like extremely; 8= Like very much; 7= Like moderately; 6= Like slightly; 5= Neither like nor dislike; 4= Dislike slightly; 3= Dislike moderately; 2= Dislike very much; 1= Dislike extremely|10 minutes post-dose|The Safety Population was defined as all treated subjects, i.e., all subjects who received any dose of study drug. The Safety Population was the primary population for both the primary and secondary endpoint analyses and the safety analysis.||Number of Participants|||Number
634059|NCT02822287|Secondary|Number of Participants With Acceptability of Warming Sensation|Acceptability of strength of warming sensation was measured by a scale: 5= Much too strong; 4=Too strong (too warming); 3= Just about right (pleasant warming); 2= Too weak (not warming enough); 1= Much too weak|10 minutes post-dose|The Safety Population was defined as all treated subjects, i.e., all subjects who received any dose of study drug. The Safety Population was the primary population for both the primary and secondary endpoint analyses and the safety analysis.||Number of Participants|||Number
639958|NCT02368314|Secondary|Frequency of Clinically Significant Bleedings||During the treatment period (14 days)||||||
634060|NCT02822287|Primary|Warming Sensation Intensity at Pre-Dose and 60 Sec (Seconds) Post-Dose|Warming Sensation Intensity was measured on 100 mm visual analogue scale (VAS), marked as “no warming sensation” on the left hand side (= 0 mm) and “strongest possible warming sensation” at the right hand side (=100 mm) at pre-dose.|Pre-dose and 60 sec post-dose|The Safety Population was defined as all treated subjects, i.e., all subjects who received any dose of study drug. The Safety Population was the primary population for both the primary and secondary endpoint analyses and the safety analysis.||Millimeters (mm)||Standard Deviation|Mean
634061|NCT02822287|Primary|Duration of Warming Sensation|Duration of action of warming sensation was measured by two stop watches started when the participants took the oral solution. First watch was stopped at the start of warming sensation and the second watch was stopped at the end. If onset of warming sensation occurred within 10 minutes of dosing but had not ended by the end of 10 minutes following dosing, then the duration was censored at 10 minutes minus the time to onset|10 minutes post-dose|The safety Population was defined as all treated subjects, i.e., all subjects who received any dose of study drug. The Safety Population was the primary population for both the primary and secondary endpoint and safety analysis. Of the 57 subjects in the Safety Population, 53 reported an onset of a warming sensation within10 minutes after dosing.||Minutes||Full Range|Median
634062|NCT02822287|Primary|Onset of Warming Sensation|Onset and duration of action of warming sensation was measured by two stop watches started when the participants took the oral solution. First watch was stopped at the start of warming sensation and the second watch was stopped at the end. If onset had not occurred by 10 minutes then time to onset was censored at 10 minutes. 53 of the 57 participants had onset within 10 minutes after dosing.|10 minutes post-dose|The Safety Population was defined as all treated subjects, i.e., all subjects who received any dose of study drug. The Safety Population was the primary population for both the primary and secondary endpoint analyses and the safety analysis.||Minutes||Full Range|Median
634063|NCT02821403|Secondary|Self-assessment of Lens Performance Through Questionnaire|"After each monthly wearing period (visits 3-5), the participants’ lens performance, night vision quality and sleep quality (total 13 questions) were assessed subjectively using a questionnaire (scoring from 1 [very unsatisfactory] to 5 [very satisfactory]).
At the end of the study, the participants were asked to choose their preferred lens type among the three pairs of lenses based on their subjective feeling of the best lens type (i.e., either clear lens, yellow tinted lens or blue-filtering coated lens).
To make it clear and simple, here we only present the data on the participants choice of their preferred lens type (i.e., simply choosing the best lens among clear lens, yellow tinted lens or blue-filtering coated lens)."|Every 1-month interval from the date of randomization, up to 3 months|||Participants|||Count of Participants
634064|NCT02821403|Primary|Color Vision as Assessed by the Farnsworth Munsell 100 Hue Test|"The Farnsworth Munsell 100 hue test (X-Rite, USA) was used to evaluate colour vision. Each of the four trays consisted of 21 movable caps. Participants were asked to sort the randomly arranged caps following the hue order from the first to the last fixed caps. The total error score was calculated, as documented in the instruction manual, to quantify the accuracy of color discrimination.
There are no defined endpoints to the total error score range.
A lower score indicates improved color discrimination ability."|Every 1-month interval from the date of randomization, up to 3 months|||units on a scale||Standard Error|Mean
634065|NCT02821403|Primary|Contrast Sensitivity as Assessed by Mars Contrast Sensitivity Chart|"Contrast sensitivity was measured using the Mars contrast sensitivity letter chart (Mars Perceptrix, Chappaqua, NY). One out of three charts differing in the letter combinations was selected randomly in order to avoid memorization of the charts. The chart was placed at 50 cm with each letter subtended 2° visual angle. We followed the recording procedures as specified by the manufacturer: participants were instructed to read the letters from high to low contrasts and the test ended when two consecutive errors were made. The contrast sensitivity was scored as the log contrast sensitivity of the last correct letter minus 0.04 log unit for every prior error. The test was administered under normal (room illumination, 400 lux) and glare conditions. A brightness acuity tester set at its medium light intensity level (100 foot lamberts) simulated the glaring condition.
A higher mean indicates improved contrast sensitivity."|Every 1-month interval from the date of randomization, up to 3 months|||log contrast sensitivity score||Standard Error|Mean
634066|NCT02818244|Primary|Primary Outcome Measure: Heart Rate Monitor Accuracy Compared to ECG Expressed as Correlation Coefficient.|The primary outcome measure is the accuracy of each heart rate monitor compared to ECG. This will be expressed by the correlation coefficient and will also be depicted by Bland-Altman plots.|24 minutes|||Concordance Correlation Coefficient wECG||95% Confidence Interval|Mean
634067|NCT02817763|Secondary|Modified Root Coverage Esthetic Score (MRES)|The MRES evaluated six variables: gingival margin (GM): 0 or 3 points; marginal tissue contour (MTC): 0 or 1 point; soft tissue texture (STT): 0 or 1 point; mucogingival junction alignment (MGJ): 0 or 1 point; gingival color (GC): 0 or 1 point; restoration/cervical lesion color (R/CLC): 0 points = color of restoration or uncovered cervical lesion does not match with tooth’s color; 3 points = good color integration. Thus, 10 points was a perfect score.|6 months|||units on a scale|photographs|Standard Deviation|Mean
634068|NCT02817763|Primary|Percentage of Defect Coverage|Percentage mean (%) of root surface covered by the surgical treatment, measured through a periodontal probe.|6 months|||percentage of root coverage|Gingival recessions|Standard Deviation|Mean
634069|NCT02815735|Primary|Comfort During the Day|Comfort during the day for comfilcon A and lotrafilcon B lenses assessed via via SMS (short message service) text message at days 3,12, and 26 at hours 8:00 am, 12:00 pm, 4:00 pm, and 8:00 pm. Scale 0-10, 0=painful, 10=can't feel the lenses.|Days 3, 12, 26|Missing data from one participant.||units on a scale||Standard Deviation|Mean
634070|NCT02815735|Primary|Comfort|Comfort (insertion, end of the day, and overall) for habitual lenses assessed at baseline and comfilcon A and lotrafilcon B lenses assessed at 2 weeks and 4 weeks. Scale 0-10, 0=painful, 10=can't feel the lenses.|Baseline, 2 weeks, 4 weeks|||units on a scale||Standard Deviation|Mean
634109|NCT02809833|Primary|Change in VAS Score of Participant-Assessed Disease Activity From Baseline to Week 12|Participant-assessed disease activity was scored on a 100-mm VAS, where the distance from 0 mm represented the participant's self evaluation of disease activity. Higher scores corresponded to increased disease activity (0 mm = no disease activity and 100 mm = maximum disease activity). The change from Baseline to Week 12 was reported, where negative changes indicated a decrease in participant-assessed disease activity.|Baseline to Week 12|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||mm||Standard Deviation|Mean
634071|NCT02814279|Secondary|Root Coverage Esthetic Score|The Root Coverage Esthetic Scale (RES; Cairo et al. 2009) was performed by two blinded and independent examiners (CFA and IFM) at the 6-month post-operative assessment. This score evaluates five variables: level of the gingival margin, marginal tissue contour, soft tissue texture, mucogingival junction alignment, and gingival color. Because complete root coverage was the primary treatment goal, and the other variables were considered secondary, the value assigned for root coverage was 60% of the total score, whereas 40% was assigned to the other four variables. With regard to assessment of the final position of the gingival margin, 3 points were given for partial root coverage, and 6 points were given for complete root coverage; 0 points were assigned when the final position of the gingival margin was equal or apical to the previous recession. One point was assigned for each of the other four variables. Thus, 10 points was a perfect score.|6 months|||units on a scale|photographs|Standard Deviation|Mean
634072|NCT02814279|Primary|Percentage of Defect Coverage|Percentage mean (%) of root surface covered by the surgical treatment, measured through a periodontal probe.|6 months|||percentage of root coverage|Gingival recessions|Standard Deviation|Mean
634073|NCT02814227|Secondary|Negative Predictive Value (NPV)|NPV of Zansors' device to detect apnea events compared to gold-standard polysomnography over an 8-hour period of sleep at 30-second intervals|8 hours|||negative predictive value|||Number
634074|NCT02814227|Secondary|Positive Predictive Value (PPV)|PPV of Zansors' device to detect apnea events compared to gold-standard polysomnography over an 8-hour period of sleep at 30-second intervals|8 hours|||positive predictive value|||Number
634075|NCT02814227|Secondary|Sensitivity|Sensitivity of Zansors' device to detect apnea events compared to gold-standard polysomnography over an 8-hour period of sleep at 30-second intervals|8 hours|||percentage of true positives|||Number
634076|NCT02814227|Primary|Specificity|Specificity of Zansors' device to detect apnea events compared to gold-standard polysomnography over an 8-hour period of sleep at 30-second intervals|8 hours|||percentage of true negatives|||Number
634077|NCT02813070|Primary|Blinded Visual Assessment of Positron Emission Tomography (PET) Imaging and Clinical Diagnosis by Japanese Readers|The performance of Flutemetanol F 18 injection in participants was determined by evaluation of the level of association between the blinded visual assessment of a participant's brain image and the participant’s clinical diagnosis by 5 Japanese readers, who classified each participant's images as either normal or abnormal (raised) Flutemetanol F 18 uptake.|Up to 90 minutes after IMP administration|Efficacy population consisted of all participants who had evaluable images following Flutemetamol F 18 injection and evaluable anatomic MRI images. As prospectively planned in the protocol, only participants enrolled with a clinical diagnosis of HV or pAD were included in the analysis of the primary endpoint.||Participants|||Count of Participants
634078|NCT02813070|Primary|Blinded Visual Assessment of Positron Emission Tomography (PET) Imaging and Clinical Diagnosis by Non-Japanese Readers|The performance of Flutemetanol F 18 injection in participants was determined by evaluation of the level of association between the blinded visual assessment of a participant’s brain image and the participant’s clinical diagnosis by 5 non-Japanese readers, who classified each participant’s images as either normal or abnormal (raised) Flutemetanol F 18 uptake.|Up to 90 minutes after investigational medicinal product (IMP) administration|Efficacy population consisted of all participants who had evaluable images following Flutemetamol F 18 injection and evaluable anatomic MRI images. As prospectively planned in the protocol, only participants enrolled with a clinical diagnosis of HV or pAD were included in the analysis of the primary endpoint.||Participants|||Count of Participants
634079|NCT02809911|Primary|Lower Extremity - Pain Sensitivity to Various Experimentally Induced Pain Stimuli|Response data by induced pain stimuli after the initial treatment with the study device in the upper extremity. The stimuli / test was determined to either favor sham or favor Provant Therapy. This included a total of 20 stimuli/tests (comparing pre-treatment to post initial treatment results) as follows: Cuff Pain Threshold (greater decrease favored), Cuff Pain Tolerance (smaller increase favored), Cuff Pressure Threshold (greater decrease favored), Pressure Tolerance (greater increase favored), Mechanical Pain Threshold (greater decrease favored), Biothesiomety (greater decrease favored) on the forearm, palm, thumb, index finger, middle finger, ring finger and pinky finger, Heat Tolerance (greater decrease favored), Cold Tolerance (greater decrease favored), Pain (greater increase favored), Time to Pain (greater increase favored), Pain Tolerance Grip Strength (greater increase favored) and Final Pain (greater decrease favored). .|4 weeks|Includes subjects in the Initial Treatment Group (Those subjects treated with either Provant or Sham at the Enrollment Visit)||Number of tests favoring arm/group|||Number
634080|NCT02809911|Primary|Upper Extremity - Pain Sensitivity to Various Experimentally Induced Pain Stimuli|Response data by induced pain stimuli after the initial treatment with the study device in the upper extremity. The stimuli / test was determined to either favor sham or favor Provant Therapy. This included a total of 20 stimuli/tests (comparing pre-treatment to post initial treatment results) as follows: Cuff Pain Threshold (greater decrease favored), Cuff Pain Tolerance (smaller increase favored), Cuff Pressure Threshold (greater decrease favored), Pressure Tolerance (greater increase favored), Mechanical Pain Threshold (greater decrease favored), Biothesiomety (greater decrease favored) on the forearm, palm, thumb, index finger, middle finger, ring finger and pinky finger, Heat Tolerance (greater decrease favored), Cold Tolerance (greater decrease favored), Pain (greater increase favored), Time to Pain (greater increase favored), Pain Tolerance Grip Strength (greater increase favored) and Final Pain (greater decrease favored).|4 weeks|Due to an error in the randomization for this study, results are based upon data only for the Initial Treatment population (those subjects treated with either active or sham at the Enrollment Visit). Data from the cross-over was not included since the majority of subjects were not crossed-over to the other treatment.||Number of tests favoring arm/group|||Number
634089|NCT02809833|Primary|Percentage of Participants With Remission According to DAS28 at Week 12|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. Remission was defined as a DAS28 score <2.6 at Week 12.|Week 12|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||percentage of participants|||Number
675776|NCT01635439|Primary|Induction to Delivery Interval||24 hours|||hours||Standard Deviation|Mean
634081|NCT02809833|Secondary|Percentage of Participants With AEs Considered Causally Related to Tocilizumab|"An AE was defined as any unfavorable and unintended sign, symptom, or disease associated with the use of tocilizumab. Worsened pre-existing conditions and laboratory or clinical tests that resulted in change or discontinuation of treatment were reported as AEs. The percentage of participants with treatment-related AEs (also known as adverse drug reactions) was reported as a separate endpoint and included both serious and non-serious AEs. Those AEs with a causal relationship reported as definite, probably, possible, or unlikely were considered to be related to tocilizumab. If the causal relationship was reported as unrelated, the AE was considered not related to tocilizumab treatment. Terms were reported verbatim as coded using Medical Dictionary for Regulatory Activities (MedDRA) Version 12.0. The most common treatment-related AEs were reported, using those from the 10 highest incidence rate levels."|Baseline to end of treatment (up to 12 months)|All Enrolled Population||percentage of participants|||Number
634082|NCT02809833|Primary|Percentage of Participants With MCII According to DAS28 at Week 52|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. MCII was defined as DAS28 reduction of ≥1.2 points from Baseline to Week 52.|Baseline to Week 52|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||percentage of participants|||Number
634083|NCT02809833|Primary|Percentage of Participants With MCII According to DAS28 at Week 36|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. MCII was defined as DAS28 reduction of ≥1.2 points from Baseline to Week 36.|Baseline to Week 36|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||percentage of participants|||Number
634084|NCT02809833|Primary|Percentage of Participants With MCII According to DAS28 at Week 24|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. MCII was defined as DAS28 reduction of ≥1.2 points from Baseline to Week 24.|Baseline to Week 24|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||percentage of participants|||Number
634085|NCT02809833|Primary|Percentage of Participants With Minimum Clinically Important Improvement (MCII) According to DAS28 at Week 12|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. MCII was defined as DAS28 reduction of ≥1.2 points from Baseline to Week 12.|Baseline to Week 12|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||percentage of participants|||Number
634086|NCT02809833|Primary|Percentage of Participants With Remission According to DAS28 at Week 52|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. Remission was defined as a DAS28 score <2.6 at Week 52.|Week 52|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||percentage of participants|||Number
634087|NCT02809833|Primary|Percentage of Participants With Remission According to DAS28 at Week 36|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. Remission was defined as a DAS28 score <2.6 at Week 36.|Week 36|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||percentage of participants|||Number
634088|NCT02809833|Primary|Percentage of Participants With Remission According to DAS28 at Week 24|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. Remission was defined as a DAS28 score <2.6 at Week 24.|Week 24|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||percentage of participants|||Number
634110|NCT02809833|Primary|VAS Score of Participant-Assessed Disease Activity at Baseline|Participant-assessed disease activity was scored on a 100-mm VAS, where the distance from 0 mm represented the participant's self evaluation of disease activity. Higher scores corresponded to increased disease activity (0 mm = no disease activity and 100 mm = maximum disease activity). The VAS score at Baseline was reported.|Baseline|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||mm||Standard Deviation|Mean
634090|NCT02809833|Primary|Percentage of Participants With Remission According to DAS28 at Baseline|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. Remission was defined as a DAS28 score <2.6 at Baseline.|Baseline|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||percentage of participants|||Number
634091|NCT02809833|Primary|Percentage of Participants With LDAS According to DAS28 at Week 52|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. LDAS was defined as a DAS28 score ≤3.2 at Week 52.|Week 52|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||percentage of participants|||Number
634092|NCT02809833|Primary|Percentage of Participants With LDAS According to DAS28 at Week 36|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. LDAS was defined as a DAS28 score ≤3.2 at Week 36.|Week 36|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||percentage of participants|||Number
634093|NCT02809833|Primary|Percentage of Participants With LDAS According to DAS28 at Week 24|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. LDAS was defined as a DAS28 score ≤3.2 at Week 24.|Week 24|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||percentage of participants|||Number
634094|NCT02809833|Primary|Percentage of Participants With LDAS According to DAS28 at Week 12|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. LDAS was defined as a DAS28 score ≤3.2 at Week 12.|Week 12|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||percentage of participants|||Number
634095|NCT02809833|Primary|Percentage of Participants With Low Disease Activity Score (LDAS) According to DAS28 at Baseline|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. LDAS was defined as a DAS28 score ≤3.2 at Baseline.|Baseline|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||percentage of participants|||Number
634096|NCT02809833|Primary|Percentage of Participants With EULAR Response at Week 52|"Response was determined using EULAR criteria based upon DAS28 absolute scores at the Week 52 visit and the DAS28 change from Baseline to Week 52. Participants with a score ≤3.2 and reduction of >1.2 points were assessed as having a Good response. Participants with a score >3.2 with reduction of >1.2 points, or a score ≤5.1 with reduction of >0.6 to ≤1.2 points, were assessed as having a Moderate response. Participants with a score >5.1 with reduction of >0.6 to ≤1.2 points, or any score with reduction ≤0.6 points, were assessed as non-responders with response recorded as No Improvement."|Baseline to Week 52|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||percentage of participants|||Number
634097|NCT02809833|Primary|Percentage of Participants With EULAR Response at Week 36|"Response was determined using EULAR criteria based upon DAS28 absolute scores at the Week 36 visit and the DAS28 change from Baseline to Week 36. Participants with a score ≤3.2 and reduction of >1.2 points were assessed as having a Good response. Participants with a score >3.2 with reduction of >1.2 points, or a score ≤5.1 with reduction of >0.6 to ≤1.2 points, were assessed as having a Moderate response. Participants with a score >5.1 with reduction of >0.6 to ≤1.2 points, or any score with reduction ≤0.6 points, were assessed as non-responders with response recorded as No Improvement."|Baseline to Week 36|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||percentage of participants|||Number
634098|NCT02809833|Primary|Percentage of Participants With EULAR Response at Week 24|"Response was determined using EULAR criteria based upon DAS28 absolute scores at the Week 24 visit and the DAS28 change from Baseline to Week 24. Participants with a score ≤3.2 and reduction of >1.2 points were assessed as having a Good response. Participants with a score >3.2 with reduction of >1.2 points, or a score ≤5.1 with reduction of >0.6 to ≤1.2 points, were assessed as having a Moderate response. Participants with a score >5.1 with reduction of >0.6 to ≤1.2 points, or any score with reduction ≤0.6 points, were assessed as non-responders with response recorded as No Improvement."|Baseline to Week 24|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||percentage of participants|||Number
634099|NCT02809833|Primary|Percentage of Participants With EULAR Response at Week 12|"Response was determined using EULAR criteria based upon DAS28 absolute scores at the Week 12 visit and the DAS28 change from Baseline to Week 12. Participants with a score ≤3.2 and reduction of >1.2 points were assessed as having a Good response. Participants with a score >3.2 with reduction of >1.2 points, or a score ≤5.1 with reduction of >0.6 to ≤1.2 points, were assessed as having a Moderate response. Participants with a score >5.1 with reduction of >0.6 to ≤1.2 points, or any score with reduction ≤0.6 points, were assessed as non-responders with response recorded as No Improvement."|Baseline to Week 12|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||percentage of participants|||Number
634100|NCT02809833|Primary|Percentage of Participants With European League Against Rheumatism (EULAR) Response at Week 4|"Response was determined using EULAR criteria based upon DAS28 absolute scores at the Week 4 visit and the DAS28 change from Baseline to Week 4. Participants with a score less than or equal to (≤) 3.2 and reduction of >1.2 points were assessed as having a Good response. Participants with a score >3.2 with reduction of >1.2 points, or a score ≤5.1 with reduction of >0.6 to ≤1.2 points, were assessed as having a Moderate response. Participants with a score >5.1 with reduction of >0.6 to ≤1.2 points, or any score with reduction ≤0.6 points, were assessed as non-responders with response recorded as No Improvement."|Baseline to Week 4|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||percentage of participants|||Number
634101|NCT02809833|Primary|Change in VAS Score of Physician-Assessed Disease Activity From Baseline to Week 52|Physician-assessed disease activity was scored on a 100-mm VAS, where the distance from 0 mm represented the physician's evaluation of disease activity. Higher scores corresponded to increased disease activity (0 mm = no disease activity and 100 mm = maximum disease activity). The change from Baseline to Week 52 was reported, where negative changes indicated a decrease in physician-assessed disease activity.|Baseline to Week 52|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||mm||Standard Deviation|Mean
634102|NCT02809833|Primary|Change in VAS Score of Physician-Assessed Disease Activity From Baseline to Week 36|Physician-assessed disease activity was scored on a 100-mm VAS, where the distance from 0 mm represented the physician's evaluation of disease activity. Higher scores corresponded to increased disease activity (0 mm = no disease activity and 100 mm = maximum disease activity). The change from Baseline to Week 36 was reported, where negative changes indicated a decrease in physician-assessed disease activity.|Baseline to Week 36|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||mm||Standard Deviation|Mean
634103|NCT02809833|Primary|Change in VAS Score of Physician-Assessed Disease Activity From Baseline to Week 24|Physician-assessed disease activity was scored on a 100-mm VAS, where the distance from 0 mm represented the physician's evaluation of disease activity. Higher scores corresponded to increased disease activity (0 mm = no disease activity and 100 mm = maximum disease activity). The change from Baseline to Week 24 was reported, where negative changes indicated a decrease in physician-assessed disease activity.|Baseline to Week 24|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||mm||Standard Deviation|Mean
634104|NCT02809833|Primary|Change in VAS Score of Physician-Assessed Disease Activity From Baseline to Week 12|Physician-assessed disease activity was scored on a 100-mm VAS, where the distance from 0 mm represented the physician's evaluation of disease activity. Higher scores corresponded to increased disease activity (0 mm = no disease activity and 100 mm = maximum disease activity). The change from Baseline to Week 12 was reported, where negative changes indicated a decrease in physician-assessed disease activity.|Baseline to Week 12|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||mm||Standard Deviation|Mean
634105|NCT02809833|Primary|VAS Score of Physician-Assessed Disease Activity at Baseline|Physician-assessed disease activity was scored on a 100-mm VAS, where the distance from 0 mm represented the physician's evaluation of disease activity. Higher scores corresponded to increased disease activity (0 mm = no disease activity and 100 mm = maximum disease activity). The VAS score at Baseline was reported.|Baseline|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||mm||Standard Deviation|Mean
634106|NCT02809833|Primary|Change in VAS Score of Participant-Assessed Disease Activity From Baseline to Week 52|Participant-assessed disease activity was scored on a 100-mm VAS, where the distance from 0 mm represented the participant's self evaluation of disease activity. Higher scores corresponded to increased disease activity (0 mm = no disease activity and 100 mm = maximum disease activity). The change from Baseline to Week 52 was reported, where negative changes indicated a decrease in participant-assessed disease activity.|Baseline to Week 52|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||mm||Standard Deviation|Mean
634107|NCT02809833|Primary|Change in VAS Score of Participant-Assessed Disease Activity From Baseline to Week 36|Participant-assessed disease activity was scored on a 100-mm VAS, where the distance from 0 mm represented the participant's self evaluation of disease activity. Higher scores corresponded to increased disease activity (0 mm = no disease activity and 100 mm = maximum disease activity). The change from Baseline to Week 36 was reported, where negative changes indicated a decrease in participant-assessed disease activity.|Baseline to Week 36|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||mm||Standard Deviation|Mean
634108|NCT02809833|Primary|Change in VAS Score of Participant-Assessed Disease Activity From Baseline to Week 24|Participant-assessed disease activity was scored on a 100-mm VAS, where the distance from 0 mm represented the participant's self evaluation of disease activity. Higher scores corresponded to increased disease activity (0 mm = no disease activity and 100 mm = maximum disease activity). The change from Baseline to Week 24 was reported, where negative changes indicated a decrease in participant-assessed disease activity.|Baseline to Week 24|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||mm||Standard Deviation|Mean
637746|NCT02472886|Secondary|HCV RNA Change From Day 1||Up to 12 weeks|Participants in Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
634111|NCT02809833|Primary|Change in SJC From Baseline to Week 52|A total of 28 joints were assessed for swollenness. The number of swollen joints could range from 0 to 28, where higher values represented more swollen joints. The change from Baseline to Week 52 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 52|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||swollen joints||Standard Deviation|Mean
634112|NCT02809833|Primary|Change in SJC From Baseline to Week 36|A total of 28 joints were assessed for swollenness. The number of swollen joints could range from 0 to 28, where higher values represented more swollen joints. The change from Baseline to Week 36 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 36|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||swollen joints||Standard Deviation|Mean
634113|NCT02809833|Primary|Change in SJC From Baseline to Week 24|A total of 28 joints were assessed for swollenness. The number of swollen joints could range from 0 to 28, where higher values represented more swollen joints. The change from Baseline to Week 24 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 24|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||swollen joints||Standard Deviation|Mean
634114|NCT02809833|Primary|Change in SJC From Baseline to Week 12|A total of 28 joints were assessed for swollenness. The number of swollen joints could range from 0 to 28, where higher values represented more swollen joints. The change from Baseline to Week 12 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 12|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||swollen joints||Standard Deviation|Mean
634115|NCT02809833|Primary|SJC at Baseline|A total of 28 joints were assessed for swollenness. The number of swollen joints at Baseline was reported and could range from 0 to 28, where higher values represented more swollen joints.|Baseline|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||swollen joints||Standard Deviation|Mean
634116|NCT02809833|Primary|Change in TJC From Baseline to Week 52|A total of 28 joints were assessed for tenderness. The number of tender joints could range from 0 to 28, where higher values represented more tender joints. The change from Baseline to Week 52 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 52|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||tender joints||Standard Deviation|Mean
634117|NCT02809833|Primary|Change in TJC From Baseline to Week 36|A total of 28 joints were assessed for tenderness. The number of tender joints could range from 0 to 28, where higher values represented more tender joints. The change from Baseline to Week 36 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 36|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||tender joints||Standard Deviation|Mean
634118|NCT02809833|Primary|Change in TJC From Baseline to Week 24|A total of 28 joints were assessed for tenderness. The number of tender joints could range from 0 to 28, where higher values represented more tender joints. The change from Baseline to Week 24 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 24|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||tender joints||Standard Deviation|Mean
634119|NCT02809833|Primary|Change in TJC From Baseline to Week 12|A total of 28 joints were assessed for tenderness. The number of tender joints could range from 0 to 28, where higher values represented more tender joints. The change from Baseline to Week 12 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 12|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||tender joints||Standard Deviation|Mean
634120|NCT02809833|Primary|TJC at Baseline|A total of 28 joints were assessed for tenderness. The number of tender joints at Baseline was reported and could range from 0 to 28, where higher values represented more tender joints.|Baseline|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||tender joints||Standard Deviation|Mean
634121|NCT02809833|Primary|Change in DAS28 From Baseline to Week 52|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 52 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 52|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||units on a scale||Standard Deviation|Mean
634122|NCT02809833|Primary|Change in DAS28 From Baseline to Week 48|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 48 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 48|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||units on a scale||Standard Deviation|Mean
634205|NCT02799069|Secondary|Change From Baseline in Total Lesion Area 3-4 Weeks After the First Photodynamic Therapy (PDT)|Percentage of change from baseline in the lesion area of all treated lesions per subject (summation of sizes of all treated lesions) assessed at 3-4 weeks after the first PDT.|3-4 weeks after the first PDT|ITT||percentage of change from baseline||Standard Deviation|Mean
639959|NCT02368314|Secondary|Frequency of Clinically Significant “Small” Bleedings||During the treatment period (14 days)||||||
634123|NCT02809833|Primary|Change in DAS28 From Baseline to Week 44|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 44 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 44|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||units on a scale||Standard Deviation|Mean
634124|NCT02809833|Primary|Change in DAS28 From Baseline to Week 40|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 40 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 40|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||units on a scale||Standard Deviation|Mean
634125|NCT02809833|Primary|Change in DAS28 From Baseline to Week 36|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 36 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 36|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||units on a scale||Standard Deviation|Mean
634126|NCT02809833|Primary|Change in DAS28 From Baseline to Week 32|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 32 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 32|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||units on a scale||Standard Deviation|Mean
634127|NCT02809833|Primary|Change in DAS28 From Baseline to Week 28|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 28 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 28|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||units on a scale||Standard Deviation|Mean
634128|NCT02809833|Primary|Change in DAS28 From Baseline to Week 24|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 24 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 24|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||units on a scale||Standard Deviation|Mean
634129|NCT02809833|Primary|Change in DAS28 From Baseline to Week 20|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 20 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 20|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||units on a scale||Standard Deviation|Mean
634130|NCT02809833|Primary|Change in DAS28 From Baseline to Week 16|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 16 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 16|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||units on a scale||Standard Deviation|Mean
634206|NCT02799069|Secondary|Complete Lesion Response Rates 12 Weeks After Last Photodynamic Therapy (PDT) Illuminated With Narrow Spectrum Devices Only|"Completely cleared individual lesions 12 weeks after last PDT comprising of individual cleared lesions 12 weeks after the first or second PDT. A second PDT was applied in case individual lesion showed no or partial response 12 weeks after the first PDT.
Lesions were illuminated during photodynamic therapy with narrow spectrum devices only (~630 nm)."|up to 12 weeks after the last PDT, up to 24 weeks after first treatment|ITT||percentage of lesions|lesions treated with narrow spectrum|95% Confidence Interval|Number
634131|NCT02809833|Primary|Change in DAS28 From Baseline to Week 12|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 12 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 12|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||units on a scale||Standard Deviation|Mean
634132|NCT02809833|Primary|Change in DAS28 From Baseline to Week 8|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 8 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 8|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||units on a scale||Standard Deviation|Mean
634133|NCT02809833|Primary|Change in DAS28 From Baseline to Week 4|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 4 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 4|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||units on a scale||Standard Deviation|Mean
634134|NCT02809833|Primary|28-Joint Disease Activity Score (DAS28) at Baseline|The DAS28 was derived from assessments of erythrocyte sedimentation rate (ESR), tender joint count (TJC), swollen joint count (SJC), and general health according to 100-millimeter (mm) Visual Analog Scale (VAS). DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in millimeters per hour (mm/h). DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The score at Baseline was reported.|Baseline|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||units on a scale||Standard Deviation|Mean
634135|NCT02809833|Primary|Percentage of Participants With Tocilizumab Dose Adjustments by Reason|"The percentage of participants with any tocilizumab dose adjustment during the study was reported among all reasons given for tocilizumab dose adjustments, as provided in the CRF. The sum of all reasons may add up to >100 percent (%) because more than one reason could be given for each dose change. In the table presented, Other Reasons refers to any reason other than those specified in categories. Similarly, Other Laboratory Change refers to a change in any laboratory parameter other than those specified in categories."|Baseline to end of treatment (up to 12 months)|"All Enrolled Population. The Number of Participants Analyzed reflects the number of participants who had at least one tocilizumab dose adjustment during the study."||percentage of participants|||Number
634136|NCT02809833|Primary|Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 52|"SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values >1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values >3 to 5 × ULN, ANC of 0.5 to 1 × 10^9 cells/L, or platelet count of 50 to 100 × 10^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values >5 × ULN, ANC <0.5 × 10^9 cells/L, or platelet count <50 × 10^3 cells/μL. The percentage of participants from each laboratory value category with (Yes) or without (No) tocilizumab dose adjustment or interruption was reported at Week 52."|Week 52|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who had available data for both the specific laboratory parameter and for the possible dose change at the corresponding visit (n) is shown in the table."||percentage of participants|||Number
634137|NCT02809833|Primary|Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 48|"SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values >1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values >3 to 5 × ULN, ANC of 0.5 to 1 × 10^9 cells/L, or platelet count of 50 to 100 × 10^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values >5 × ULN, ANC <0.5 × 10^9 cells/L, or platelet count <50 × 10^3 cells/μL. The percentage of participants from each laboratory value category with (Yes) or without (No) tocilizumab dose adjustment or interruption was reported at Week 48."|Week 48|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who had available data for both the specific laboratory parameter and for the possible dose change at the corresponding visit (n) is shown in the table."||percentage of participants|||Number
634162|NCT02806505|Secondary|Percentage of Participants With Virological Response (Non-detectable Hepatitis C Virus-ribonucleic Acid [HCV RNA]) at End of Treatment (EOT)|Virological response at the end of study treatment was defined as the percentage of participants with undetectable HCV RNA. This response rate at end of treatment was calculated as the number of participants with undetectable HCV RNA divided by the number of participants of the respective participant population.|EOT (Week 48)|The ITT analysis population included all the randomized participants who received at least one dose of study treatment.||percentage of participants||95% Confidence Interval|Number
639960|NCT02368314|Secondary|Frequency of “Big” Bleedings||During the treatment period (14 days)||||||
634138|NCT02809833|Primary|Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 44|"SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values >1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values >3 to 5 × ULN, ANC of 0.5 to 1 × 10^9 cells/L, or platelet count of 50 to 100 × 10^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values >5 × ULN, ANC <0.5 × 10^9 cells/L, or platelet count <50 × 10^3 cells/μL. The percentage of participants from each laboratory value category with (Yes) or without (No) tocilizumab dose adjustment or interruption was reported at Week 44."|Week 44|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who had available data for both the specific laboratory parameter and for the possible dose change at the corresponding visit (n) is shown in the table."||percentage of participants|||Number
634139|NCT02809833|Primary|Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 40|"SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values >1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values >3 to 5 × ULN, ANC of 0.5 to 1 × 10^9 cells/L, or platelet count of 50 to 100 × 10^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values >5 × ULN, ANC <0.5 × 10^9 cells/L, or platelet count <50 × 10^3 cells/μL. The percentage of participants from each laboratory value category with (Yes) or without (No) tocilizumab dose adjustment or interruption was reported at Week 40."|Week 40|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who had available data for both the specific laboratory parameter and for the possible dose change at the corresponding visit (n) is shown in the table."||percentage of participants|||Number
634140|NCT02809833|Primary|Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 36|"SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values >1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values >3 to 5 × ULN, ANC of 0.5 to 1 × 10^9 cells/L, or platelet count of 50 to 100 × 10^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values >5 × ULN, ANC <0.5 × 10^9 cells/L, or platelet count <50 × 10^3 cells/μL. The percentage of participants from each laboratory value category with (Yes) or without (No) tocilizumab dose adjustment or interruption was reported at Week 36."|Week 36|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who had available data for both the specific laboratory parameter and for the possible dose change at the corresponding visit (n) is shown in the table."||percentage of participants|||Number
634141|NCT02809833|Primary|Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 32|"SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values >1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values >3 to 5 × ULN, ANC of 0.5 to 1 × 10^9 cells/L, or platelet count of 50 to 100 × 10^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values >5 × ULN, ANC <0.5 × 10^9 cells/L, or platelet count <50 × 10^3 cells/μL. The percentage of participants from each laboratory value category with (Yes) or without (No) tocilizumab dose adjustment or interruption was reported at Week 32."|Week 32|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who had available data for both the specific laboratory parameter and for the possible dose change at the corresponding visit (n) is shown in the table."||percentage of participants|||Number
634142|NCT02809833|Primary|Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 28|"SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values >1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values >3 to 5 × ULN, ANC of 0.5 to 1 × 10^9 cells/L, or platelet count of 50 to 100 × 10^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values >5 × ULN, ANC <0.5 × 10^9 cells/L, or platelet count <50 × 10^3 cells/μL. The percentage of participants from each laboratory value category with (Yes) or without (No) tocilizumab dose adjustment or interruption was reported at Week 28."|Week 28|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who had available data for both the specific laboratory parameter and for the possible dose change at the corresponding visit (n) is shown in the table."||percentage of participants|||Number
634143|NCT02809833|Primary|Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 24|"SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values >1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values >3 to 5 × ULN, ANC of 0.5 to 1 × 10^9 cells/L, or platelet count of 50 to 100 × 10^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values >5 × ULN, ANC <0.5 × 10^9 cells/L, or platelet count <50 × 10^3 cells/μL. The percentage of participants from each laboratory value category with (Yes) or without (No) tocilizumab dose adjustment or interruption was reported at Week 24."|Week 24|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who had available data for both the specific laboratory parameter and for the possible dose change at the corresponding visit (n) is shown in the table."||percentage of participants|||Number
637747|NCT02472886|Secondary|Percentage of Participants With HCV RNA < LLOQ on Treatment||Up to 12 weeks|Full Analysis Set||percentage of participants||95% Confidence Interval|Number
634144|NCT02809833|Primary|Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 20|"SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values >1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values >3 to 5 × ULN, ANC of 0.5 to 1 × 10^9 cells/L, or platelet count of 50 to 100 × 10^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values >5 × ULN, ANC <0.5 × 10^9 cells/L, or platelet count <50 × 10^3 cells/μL. The percentage of participants from each laboratory value category with (Yes) or without (No) tocilizumab dose adjustment or interruption was reported at Week 20."|Week 20|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who had available data for both the specific laboratory parameter and for the possible dose change at the corresponding visit (n) is shown in the table."||percentage of participants|||Number
634145|NCT02809833|Primary|Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 16|"SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values >1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values >3 to 5 × ULN, ANC of 0.5 to 1 × 10^9 cells/L, or platelet count of 50 to 100 × 10^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values >5 × ULN, ANC <0.5 × 10^9 cells/L, or platelet count <50 × 10^3 cells/μL. The percentage of participants from each laboratory value category with (Yes) or without (No) tocilizumab dose adjustment or interruption was reported at Week 16."|Week 16|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who had available data for both the specific laboratory parameter and for the possible dose change at the corresponding visit (n) is shown in the table."||percentage of participants|||Number
634146|NCT02809833|Primary|Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 12|"SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values >1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values >3 to 5 × ULN, ANC of 0.5 to 1 × 10^9 cells/L, or platelet count of 50 to 100 × 10^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values >5 × ULN, ANC <0.5 × 10^9 cells/L, or platelet count <50 × 10^3 cells/μL. The percentage of participants from each laboratory value category with (Yes) or without (No) tocilizumab dose adjustment or interruption was reported at Week 12."|Week 12|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who had available data for both the specific laboratory parameter and for the possible dose change at the corresponding visit (n) is shown in the table."||percentage of participants|||Number
634147|NCT02809833|Primary|Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 8|"SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values >1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values >3 to 5 × ULN, ANC of 0.5 to 1 × 10^9 cells/L, or platelet count of 50 to 100 × 10^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values >5 × ULN, ANC <0.5 × 10^9 cells/L, or platelet count <50 × 10^3 cells/μL. The percentage of participants from each laboratory value category with (Yes) or without (No) tocilizumab dose adjustment or interruption was reported at Week 8."|Week 8|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who had available data for both the specific laboratory parameter and for the possible dose change at the corresponding visit (n) is shown in the table."||percentage of participants|||Number
634148|NCT02809833|Primary|Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 4|"SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values greater than (>) 1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values >3 to 5 × ULN, ANC of 0.5 to 1 × 10^9 cells/L, or platelet count of 50 to 100 × 10^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values >5 × ULN, ANC less than (<) 0.5 × 10^9 cells/L, or platelet count <50 × 10^3 cells/μL. The percentage of participants from each laboratory value category with (Yes) or without (No) tocilizumab dose adjustment or interruption was reported at Week 4."|Week 4|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who had available data for both the specific laboratory parameter and for the possible dose change at the corresponding visit (n) is shown in the table."||percentage of participants|||Number
634149|NCT02809833|Primary|Percentage of Participants With Categorized Laboratory Data Available at Week 52|SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and low platelet count to guide dose decisions. Laboratory values for ALAT and ASAT were to be categorized in reference to the institution-specific ULN. Laboratory values for ANC and platelet count were to be categorized in reference to a normal range outlined in the SmPC. This range was 0.5 to 1 × 10^9 cells/L for ANC and 50 to 100 × 10^3 cells/μL for platelet count. The percentage of participants with ≥1 documented/evaluable laboratory value at Week 52 was reported, along with the percentage of participants with categorized laboratory data available for each individual parameter.|Week 52|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||percentage of participants|||Number
634179|NCT02799082|Secondary|Local Skin Reactions|Local skin reactions observed immediately after illumination by the investigator were documented using different categories (erythema, edema, induration, vesicles, erosion, ulceration, scaling/flanking, scabbing/crusting,weeping/exudates).|during and after PDT [3h - 4 h]|Safety Population, Overall reactions after first and/or second PDT||Participants|||Count of Participants
634150|NCT02809833|Primary|Percentage of Participants With Categorized Laboratory Data Available at Week 24|SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and low platelet count to guide dose decisions. Laboratory values for ALAT and ASAT were to be categorized in reference to the institution-specific ULN. Laboratory values for ANC and platelet count were to be categorized in reference to a normal range outlined in the SmPC. This range was 0.5 to 1 × 10^9 cells/L for ANC and 50 to 100 × 10^3 cells/μL for platelet count. The percentage of participants with ≥1 documented/evaluable laboratory value at Week 24 was reported, along with the percentage of participants with categorized laboratory data available for each individual parameter.|Week 24|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||percentage of participants|||Number
634151|NCT02809833|Primary|Percentage of Participants With Categorized Laboratory Data Available at Baseline|SmPC recommendations were specified in the collection of routine laboratory samples for alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT), absolute neutrophil count (ANC), and low platelet count to guide dose decisions. Laboratory values for ALAT and ASAT were to be categorized in reference to the institution-specific upper limit of normal (ULN). Laboratory values for ANC and platelet count were to be categorized in reference to a normal range outlined in the SmPC. This range was 0.5 to 1 × 10^9 cells per liter (cells/L) for ANC and 50 to 100 × 10^3 cells per microliter (cells/μL) for platelet count. The percentage of participants with greater than or equal to (≥) 1 documented/evaluable laboratory value at Baseline was reported, along with the percentage of participants with categorized laboratory data available for each individual parameter.|Baseline|All Enrolled Population.||percentage of participants|||Number
634152|NCT02808130|Primary|Total Antioxidant Capacity Levels in Gingival Crevicular Fluid as a Marker of Antioxidant Status|Contrary to oxidant mediators, TAOC provides an extensive overview of the antioxidant status of the individuals and how well these antioxidants are able to protect host cells during periods of oxidative stress. Due to the potential synergistic effects of different antioxidant molecules, the measurement of TAOC can provide a more accurate and extensive assessment of antioxidant status rather than the separate measurement of individual antioxidant molecules|8-10 am on the day following periodontal status assessment.|||pg/ml||Standard Error|Mean
634153|NCT02808130|Primary|Protein Carbonyl Level in Gingival Crevicular Fluid as a Marker of Protein Oxidation|Protein carbonylation is another nonenzymatic oxidative post-translational modification and assesed by protein carbonyl tissue content that is often used as a biomarker of oxidative stress.|8-10 am on the day following periodontal status assessment.|||pg/ml||Standard Error|Mean
634154|NCT02808130|Primary|Gingival Crevicular Fluid Level of Malondialdehyde (MDA) as a Marker of Lipid Oxidation.|Malondialdehyde levels in gingival crevicular fluid as measured an oxidative stress marker in lipid. Malondialdehyde (MDA) is the most specific and the most often used molecule in the measurement of biological lipid oxidation|8-10 am on the day following periodontal status assessment.|||pg/ml||Standard Error|Mean
634155|NCT02806544|Secondary|Breast Conserving Therapy|"The rate of breast conservation surgery (as opposed to mastectomy) after 4 months of neoadjuvant tamoxifen therapy in patients who were deemed to be responders to neoadjuvant tamoxifen (Ki67 < or = 10% after 4-6 weeks on neoadjuvant tamoxifen therapy)."|4-6 months|This outcome measure was analyzed in patients who were treated with 4 months of neoadjuvant tamoxifen||participants|||Number
634156|NCT02806544|Secondary|Pathologic Complete Response|Pathologic complete response was defined as no residual tumor at the primary site or the axillary lymph nodes at the time of surgery.|4-6 months|This Outcome Measure was only assessed among patients who had undergone surgery.||participants|||Number
634157|NCT02806544|Secondary|Overall Clinical Response Rate|Clinical response rate was assessed by palpation after 4 months of tamoxifen. Complete response was defined as no palpable primary tumor on clinical examination and lymph nodes < 10 mm. Partial response was defined as at least 30% decrease in the sum of the diameters compared to baseline sum of diameters. The overall clinical response was the sum of the complete clinical response and partial clinical response.|4-6 months|This Outcome Measure was only assessed among patients undergoing surgery and is a unique outcome measure.||participants|||Number
634158|NCT02806544|Secondary|Ki67 Suppression Rate at 4-6 Weeks in Patients Who Underwent an On-treatment Biopsy|Result is the number of participants who had Ki67 suppression (< or = 10%) after 4-6 weeks of neoadjuvant tamoxifen out of patients who underwent an on-treatment biopsy.|4-6 weeks|32 of the 35 patients underwent an on-treatment biopsy; 3 patients did not follow-up and were not included in the number of participants analyzed for this measure.||participants|||Number
634159|NCT02806544|Secondary|Number of Participants With Definitive Surgery in Responders to Neoadjuvant Tamoxifen|"Rate of definitive surgery after 4 months of neoadjuvant tamoxifen therapy in patients who were deemed to be responders to neoadjuvant tamoxifen (Ki67 < or = 10% after 4-6 weeks on neoadjuvant tamoxifen therapy)"|4-6 months|||participants|||Number
634160|NCT02806544|Primary|Number of Participants Who Were Successfully Accrued in the Study, as a Measure of Feasibility|Feasibility is defined as the ability to recruit the stated number of patients and fifty percent of participants completing the trial. Completing the trial is defined as reaching surgery if they are a responder to tamoxifen or obtaining the six week biopsy specimen if they are a non-responder.|4-6 months|The number of patients analyzed was the accrual goal for number of participants and the outcome measure was the actual number of participants accrued. The outcome measure time frame is the maximum time each participant would be on study.||participants|||Number
634161|NCT02806505|Secondary|Percentage of Participants With Virological Response (at Least a 2-log 10 Decrease in HCV RNA as Compared With Baseline or Unquantifiable [Less Than {<} 600 International Unit/Milliliter {IU/mL}] or Undetectable HCV RNA [< 50 IU/mL]) at Week 12 and 24|Virological response at Weeks 12 and 24 was computed as the percentage of participants with at least a 2-log 10 decrease in HCV RNA at Weeks 12 and 24 as compared with baseline or with an unquantifiable (< 600 IU/mL) or an undetectable HCV RNA test result (< 50 IU/mL) at Week 12 and at Week 24, calculated as the number of participants meeting this criterion divided by the number of participants of the respective participant population.|Weeks 12 and 24|The ITT analysis population included all the randomized participants who received at least one dose of study treatment.||percentage of participants||95% Confidence Interval|Number
634294|NCT02777125|Secondary|Number of Participants Requiring Repeat Visits|Defined as a repeat visit to the Emergency Department for a complaint related to their wheezing, within 7 days of initial enrollment in the study.|Within 7 days of initial presentation|||Participants|||Count of Participants
634163|NCT02806505|Primary|Percentage of Participants With Sustained Virological Response (SVR) at 24 Weeks After End of Treatment|SVR was defined as the percentage of patients with undetectable HCV RNA. SVR rate was calculated as the number of participants with an undetectable HCV RNA divided by the number of participants of the respective participant population. The last single HCV RNA less than (<) 50 international units per millilitre (IU/mL) measured >=140 days after treatment end (i.e., >= 20 weeks after treatment end) was used to determine SVR. Participants without measurements in this time window were considered to be nonresponders.|24 weeks after end of treatment (Week 72)|The ITT analysis population included all the randomized participants who received at least one dose of study treatment.||percentage of participants||95% Confidence Interval|Number
634164|NCT02805907|Secondary|Quality of Life Measured With Mini-AQLQ (Asthma Quality of Life Questionnaire)|Mini-AQLQ (Asthma Quality of Life Questionnaire): The response options for each item are placed on an equidistant 7-point scale, where 1 = maximum limitation and 7 = no limitation. The questionnaire Global score, which is the mean for all 15 items that make up the scale, and a score for each dimension, which is the average of the corresponding items for that dimension.|6 months|||units on a scale||Standard Deviation|Mean
634165|NCT02805907|Secondary|Dose Inhaled Corticosteroids as the Scale of the Spanish Guide for Asthma Management (GEMA 4.0)|"Dose inhaled corticosteroids as the scale of the Spanish guide for asthma management (GEMA 4.0): Depends on the type of steroids:
Beclomethasone dipropionate (Low dose: 200-500 mcg/day, Half dose: 501-1000 mcg/day, High dose: 1001-2000 mcg/day), Beclomethasone extrafine (Low dose: 100-200 mcg/day, Half dose: 201-400 mcg/day, High dose: > 400 mcg/day), Budesonide (Low dose: 200-400 mcg/day, Half dose: 401-800 mcg/day, High dose: 801-1600 mcg/day), Ciclesonide (Low dose: 80-160 mcg/day, Half dose: 161-320 mcg/day, High dose: 321-1280 mcg/day), Fluticasone furoate (Half dose: 92 mcg/day, High dose: 184 mcg/day), Fluticasone propionate (Low dose: 100-250 mcg/day, Half dose: 251-500 mcg/day, High dose: 501-1000 mcg/day), Mometasone furoate (Low dose: 100-200 mcg/day, Half dose: 201-400 mcg/day, High dose: 401-800 mcg/day),"|6 months|||Participants|||Count of Participants
634166|NCT02805907|Secondary|Number of Asthma Exacerbations|Number of asthma exacerbations during the study period|6 months|||Asthma exacerbations||Standard Deviation|Mean
634167|NCT02805907|Primary|Asthma Control Measured With Asthma Control Test (ACT)|Asthma Control Test (ACT): Interpretation of the ACT questionnaire: Score less than or equal to 15 points: poor control; Between 16 and 19 points: partially controlled; Greater or equal to 20 points: good control.|6 months|||units on a scale||Standard Deviation|Mean
634168|NCT02802592|Secondary|Change in Quality of Life as Assessed by Short Form-36 Quality of Life Survey||assessed at 1-week, 1-month, and 3-months from date of surgery||||||
634169|NCT02802592|Secondary|Overall Hospitalization Cost||up to one year from date of surgery|This study was terminated prematurely due to a loss of funding. There is no data available for this outcome measure as any data collected was not unblinded to the study team nor was it analyzed.|||||
634170|NCT02802592|Secondary|Length of Stay (# of Total Days Hospitalized)||up to one year from date of surgery|This study was terminated prematurely due to a loss of funding. There is no data available for this outcome measure as any data collected was not unblinded to the study team nor was it analyzed.|||||
634171|NCT02802592|Primary|Total Number of Packed Red Blood Cells Transfused During the Intraoperative and Immediate Postoperative Period||Start of surgery to 96 hours post op|This study was terminated prematurely due to a loss of funding. There is no data available for this outcome measure as any data collected was not unblinded to the study team nor was it analyzed.|||||
634172|NCT02801396|Primary|Percentage of Eyes With Acceptable Cosmetic Lens Fit|Cosmetic lens fitting is assessed for each subject eye in the primary gaze position without a slit lamp. Cosmetic lens fit is a binary response and is reported as acceptable or unacceptable. The Percentage of subject eyes with acceptable cosmetic lens fitting is reported.|30 Minutes Post Insertion|Subjects that completed all study visits without a major protocol deviation.||Percentage of eyes|Eyes||Number
634173|NCT02801396|Primary|Percentage of Eyes With Acceptable Mechanical Lens Fit|Mechanical lens fit will be assessed for each subject and eye using a slit lamp. Lens fit is a binary response and 'Yes' = Acceptable Fit and 'No' = Unacceptable Fit. Lens fit is assessed using Lens centration, limbal exposure, primary gaze movement, up-gaze movement, edge lift, lens tightness. Unacceptable fit will be declared if there is any of the following present: limbal exposure, edge lift, excessive movement in primary or up-gaze or insufficient movement in primary gaze and up-gaze. The Percentage of subject eyes with acceptable lens fit will be reported.|30 Minutes Post Insertion|Subjects that completed all study visits without a major protocol deviation.||Percentage of eyes|Eyes||Number
634174|NCT02801396|Primary|Visual Performance (LogMar)|Distance time controlled Visual Performance (LogMAR) was assessed for each subject eye under bright-illumination high-contrast lighting conditions at 4m using an ETDRS chart. The average visual performance (LogMAR) was reported for each study lens.|30 Minutes Post Insertion|Subjects that completed all study visits without a major protocol deviation.||LogMAR|Eyes|Standard Deviation|Mean
634175|NCT02801396|Primary|CLUE Handling|CLUE Handling is assessed using the Contact Lens User Experience (CLUE™) Questionnaire. CLUE™ is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact lens-wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable / positive response. 97% of the scores fall within 0 and 120 (mean +/- 3XSD).|30 Minutes Post Insertion|Subjects that completed all study visits without a major protocol deviation.||Units on a scale||Standard Deviation|Mean
634177|NCT02799082|Secondary|Related Adverse Events /AEs)|Related treatment-emerged-adverse events (TEAEs) until 12 weeks after the last PDT (>=5%) TEAEs were reported from the day of the 1st PDT until the end-of-study (clinical part), i.e. 12 weeks after the last PDT (until 12 weeks after the 1st PDT or up to 24 weeks in case a 2nd PDT was applied).|up to 24 weeks after the 1st PDT|safety population||Participants|||Count of Participants
634178|NCT02799082|Secondary|Discomfort During and After PDT|Local discomfort experienced by the patient after illumination were documented in three categories: itching, burning, pain.|during and after PDT [3h - 4 h]|Safety Population (Overall reactions after first and/or second PDT)||Participants|||Count of Participants
634180|NCT02799082|Secondary|Overall Cosmetic Outcome 12 Weeks After the Last PDT|Overall Cosmetic Outcome (CO) 12 weeks after PDT (12 weeks after 1st PDT or 12 weeks after 2nd PDT). The cosmetic outcome at the end-of-study visit was calculated on the basis of skin quality assessment: skin surface, hyperpigmentation, hypopigmentation, mottled/irregular pigmentation, degree of scarring, and atrophy. The CO was rated as very good if the sum score of the previously mentioned ratings (all ratings for each sign added up) has improved by at least 2 points as compared to baseline; the CO was rated as good if the sum score at a given visit has improved by at least 1 point as compared to baseline; the cosmetic outcome is rated as satisfactory if the sum score at a given visit is identical to the one at baseline; the cosmetic outcome is rated as unsatisfactory if the sum score at a given visit has worsened by 1 point compared to baseline, the cosmetic outcome is rated as impaired if the sum score at a given visit has worsened by at least 2 points compared to baseline.|12 weeks after the last PDT, up to 24 weeks|FAS||Participants|||Count of Participants
634181|NCT02799082|Secondary|Subjects With Partial Clearance 12 Weeks After the Last PDT|Percentage of subjects with clearance of at least 75% of lesions 12 weeks after the last PDT (12 weeks after the 1st PDT or 12 weeks after the 2nd PDT in case of retreatment).|12 weeks after the last PDT, up to 24 weeks|FAS||percentage of patients||95% Confidence Interval|Number
634182|NCT02799082|Secondary|Subjects With Complete Clearance 12 Weeks After the First PDT|AK clearance rate, defined as the number of subjects with complete remission of all AK lesions assessed at 12 weeks after the first PDT|12 weeks after the first PDT|FAS||percentage of patients||95% Confidence Interval|Number
634183|NCT02799082|Secondary|Change in Total Lesion Area 12 Weeks After the Last PDT (Treated Area Scalp)|"Change in mean total lesion area within the target treatment area per subject 12 weeks after the last PDT compared to baseline (12 weeks after the 1st PDT or 12 weeks after the 2nd PDT in case of retreatment). The outcome measure describes the mean difference between total lesion size at baseline and 12 weeks after the last PDT. Negative values indicate a reduction in the total lesion area size compared to baseline.
Subgroup Analysis for patients with lesions located in the scalp only."|12 weeks after the last PDT, up to 24 weeks|FAS||mm²||Standard Deviation|Mean
634184|NCT02799082|Secondary|Change in Total Lesion Area 12 Weeks After the Last PDT (Treated Area Face)|"Change in mean total lesion area within the target treatment area per subject 12 weeks after the last PDT compared to baseline (12 weeks after the 1st PDT or 12 weeks after the 2nd PDT in case of retreatment). The outcome measure describes the mean difference between total lesion size at baseline and 12 weeks after the last PDT. Negative values indicate a reduction in the total lesion area size compared to baseline.
Subgroup Analysis for patients with lesions located in the face only."|12 weeks after the last PDT, up to 24 weeks|FAS||mm²||Standard Deviation|Mean
634185|NCT02799082|Secondary|Change in Total Lesion Size 12 Weeks After the Last PDT|"Change in the mean total lesion area 12 weeks per subject after the last PDT compared to baseline (12 weeks after the 1st PDT or 12 weeks after the 2nd PDT in case of retreatment).
The outcome measure describes the mean difference between total lesion size at baseline and 12 weeks after the last PDT. Negative values indicate a reduction in the total lesion area size compared to baseline."|12 weeks after the last PDT, up to 24 weeks|FAS (Overall)||mm²||Standard Deviation|Mean
634186|NCT02799082|Secondary|Percentage of AK Lesions Showing Complete Remission Treated With Narrow Spectrum Lamp 12 Weeks After the Last PDT|"Percentage of individual lesions completely cleared and with no adherent scaling plaques of AK that were visible any longer 12 weeks after the last PDT (12 weeks after the 1st PDT or 12 weeks after the 2nd PDT in case of retreatment).
for subgroup analysis: patients treated with narrow spectrum lamp only."|12 weeks after the last PDT, up to 24 weeks|FAS, subgroup: lesions treated with narrow spectrum lamp only||percentage of lesions|lesions -PDT with narrow spectrum lamp|95% Confidence Interval|Number
634187|NCT02799082|Secondary|Percentage of AK Lesions Showing Complete Remission 12 Weeks After the Last PDT|Percentage of individual lesions completely cleared and with no adherent scaling plaques of AK that were visible any longer 12 weeks after the last PDT (12 weeks after the 1st PDT or 12 weeks after the 2nd PDT in case of retreatment); Overall population|12 weeks after the last PDT, up to 24 weeks|FAS (Overall)||percentage of lesions|individual lesions|95% Confidence Interval|Number
634188|NCT02799082|Primary|Total Patient Clearance Rate Treated With Narrow Spectrum Lamp 12 Weeks After the Last Photodynamic Therapy (PDT)|"AK clearance rate, defined as the percentage of subjects with complete remission of all AK lesions in the target area(s) assessed 12 weeks after the last PDT (12 weeks after the 1st PDT or 12 weeks after the 2nd PDT in case of retreatment).
Analysis was for the subgroup: treated by narrow spectrum lamps only [n=13 (vehicle), n= 28 (BF-200 ALA)]"|12 weeks after the last PDT, up to 24 weeks|PPP; subgroup analysis for patients only treated with narrow spectrum lamps||percentage of patients||95% Confidence Interval|Number
634189|NCT02799082|Primary|Total Patient Clearance Rate Treated With Narrow Spectrum Lamp 12 Weeks After the Last Photodynamic Therapy (PDT)|"AK clearance rate, defined as the percentage of subjects with complete remission of all AK lesions in the target area(s) assessed 12 weeks after the last PDT (12 weeks after the 1st PDT or 12 weeks after the 2nd PDT in case of retreatment).
Analysis was for the subgroup: treated by narrow spectrum lamps only [n=15 (vehicle), n= 31 (BF-200 ALA)]"|12 weeks after the last PDT, up to 24 weeks|FAS; subgroup analysis for patients only treated with narrow spectrum lamps||percentage of participants||95% Confidence Interval|Number
634190|NCT02799082|Primary|Total Patient Clearance Rate 12 Weeks After the Last Photodynamic Therapy (PDT)|AK clearance rate, defined as the percentage of subjects with complete remission of all AK lesions in the target area(s) assessed 12 weeks after the last PDT (12 weeks after the 1st PDT or 12 weeks after the 2nd PDT in case of retreatment).|12 weeks after the last PDT, up to 24 weeks|per protocol population (PPP), (Overall)||percentage of participants||95% Confidence Interval|Number
634191|NCT02799082|Primary|Total Patient Clearance Rate 12 Weeks After the Last Photodynamic Therapy (PDT)|AK clearance rate, defined as the percentage of subjects with complete remission of all AK lesions in the target area(s) assessed 12 weeks after the last PDT (12 weeks after the 1st PDT or 12 weeks after the 2nd PDT in case of retreatment).|12 weeks after the last photodynamic therapy (PDT), up to 24 weeks|Full analysis set (FAS), Overall||percentage of participants||95% Confidence Interval|Number
634204|NCT02799069|Secondary|Change From Baseline in Total Lesion Area 12 Weeks After the First Photodynamic Therapy (PDT)|the change from baseline in the lesion area of all treated lesions per subject (summation of sizes of all treated lesions) assessed 12 weeks after the first PDT.|12 weeks after the first PDT|ITT||percentage of change from baseline||Standard Deviation|Mean
634192|NCT02799069|Secondary|Adverse Reactions|"Adverse reactions are Treatment-Emergent Adverse Events considered at least possibly related to the treatment with the randomized investigational medicinal products; Adverse reactions are shown with a frequency cut off of >=5%.
TEAEs are considered from subjects who received only one PDT or subjects who received 2 PDTs (initial Treatment (PDT-1) and retreatment (PDT-2) due to remaining lesions 12 weeks after first photodynamic therapy.
The safety set consists of all patients treated at least once with investigational product. Treatment with investigational product consists of application of study drug followed by illumination. This excludes one patient from the safety set; for this patient the investigational product was applied on the skin but it was not illuminated. Patients are treated according to actual treatment."|up to 12 weeks after the last PDT, up to 24 weeks after first treatment|safety population||Participants|||Count of Participants
634193|NCT02799069|Secondary|Local Discomfort - Pain During Second Photodynamic Therapy (PDT-2) for Retreated Subjects|"Pain (11-point numeric rating scale) by PDT Session; Overall (If both areas have been treated, maximum intensity over both areas is used for analysis.) Patients assessed the pain experienced during PDT using an 11-point numeric rating pain scale (NRPS) ranging from 0 (no pain at all) to 10 (worst possible pain). This score reflects the patient's maximum pain during PDT.
Only applicable for subjects who received a retreatment (PDT-2) due to remaining lesions 12 weeks after the first treatment (PDT-1) (subjects with data)"|during PDT treatment [3 h - 4 h ]|Safety Population||units on a scale||Standard Deviation|Mean
634194|NCT02799069|Secondary|Local Discomfort - Pain During First Photodynamic Therapy (PDT-1)|Pain (11-point numeric rating scale) by PDT Session; Overall (If both areas have been treated, maximum intensity over both areas is used for analysis.) Patients assessed the pain experienced during PDT using an 11-point numeric rating pain scale (NRPS) ranging from 0 (no pain at all) to 10 (worst possible pain). This score reflects the patient's maximum pain during PDT. This outcome measure shows pain score after the first PDT.|during PDT treatment [3 h - 4 h ]|Safety Population||units on a scale||Standard Deviation|Mean
634195|NCT02799069|Secondary|Local Discomfort During Second Photodynamic Therapy (PDT-2) for Retreated Subjects|Local discomfort reported by the patients during Illumination phase of retreatment (PDT-2); only applicable for subjects who received a retreatment (PDT-2) due to remaining lesions 12 weeks after the first treatment (PDT-1) (subjects with data)|during PDT treatment [3 h - 4 h ]|Safety Population - retreated subjects only||percentage of patients|||Number
634196|NCT02799069|Secondary|Local Discomfort During First Photodynamic Therapy (PDT-1)|Local discomfort reported by the patients during Illumination of first PDT (PDT1)|during PDT treatment [3 h - 4 h ]|Safety Population||percentage of patients|||Number
634197|NCT02799069|Secondary|Local Skin Reactions During Second Photodynamic Therapy (PDT-2) for Retreated Subjects|Local skin reactions in the treatment area as assessed by the investigator during PDT-2; only applicable for subjects who were retreated with a second PDT due to remaining lesions 12 weeks after the first PDT (subjects with data).|during PDT treatment [3 h - 4 h ]|Safety Population - retreated subjects only||percentage of patients|||Number
634198|NCT02799069|Secondary|Local Skin Reactions During First Photodynamic Therapy (PDT-1)|Local skin reactions in the treatment area as assessed by the investigator during the first PDT (PDT-1)|during PDT treatment [3 h - 4 h ]|Safety Population||percentage of patients|||Number
634199|NCT02799069|Secondary|Overall Cosmetic Outcome of the Treated Skin 12 Weeks After Last Photodynamic Therapy (PDT) Compared to Baseline|The cosmetic outcome 12 weeks after the last PDT (12 weeks after 1st PDT for subjects who are completely cleared at this time point, 12 weeks after 2nd PDT for subjects retreated due to remaining lesions 12 weeks after 1st PDT) will be calculated on the basis of the skin quality assessment (skin surface, hyperpigmentation, hypopigmentation, mottled or irregular pigmentation, degree of scarring, and atrophy) upon visual examination (scale: 0= none, 1= mild, 2= moderate, 3=severe). The cosmetic outcome is rated as very good if the sum score of the previously mentioned ratings (all ratings for each sign added up) has improved by at least 2 points as compared to baseline; as good if the sum score has improved by at least 1 point as compared to baseline; as satisfactory if the sum score is identical to the one at baseline; as unsatisfactory if the sum score has worsened by 1 point compared to baseline and as impaired if the sum score has worsened by at least 2 points compared to baseline.|12 weeks after the last PDT, up to 24 weeks after first treatment|ITT||percentage of patients||95% Confidence Interval|Number
634200|NCT02799069|Secondary|Change From Baseline in Total Lesion Area 12 Weeks After Last Photodynamic Therapy (PDT)|the change from baseline in the lesion area of all treated lesions per subject (summation of sizes of all treated lesions) assessed at 12 weeks after last PDT, combining the changes from baseline in total lesion area at 12 weeks after the first PDT and at 12 weeks after the second PDT (a second PDT was applied to subjects with non- or partially responding lesions 12 weeks after the first PDT).|12 weeks after the last PDT, up to 24 weeks after the first treatment|ITT||percentage of change from baseline||Standard Deviation|Mean
634201|NCT02799069|Secondary|Change From Baseline in Total Lesion Area 3-4 Weeks After Last Photodynamic Therapy (PDT)|the change from baseline in the lesion area of all treated lesions per subject (summation of sizes of all treated lesions) assessed at 3-4 weeks after last PDT, combining the changes from baseline in total lesion area of subjects 3-4 weeks after first PDT and second PDT (a second PDT was applied for subjects who showed non- or partially responding lesions 12 weeks after the first PDT).|3-4 weeks after the last PDT, up to 16 weeks after the first treatment|ITT||percentage of change from baseline||Standard Deviation|Mean
634202|NCT02799069|Secondary|Change From Baseline in Total Lesion Area 12 Weeks After Second Photodynamic Therapy (PDT)|the change from baseline in the lesion area of all treated lesions per subject (summation of sizes of all treated lesions) assessed 12 weeks after the second PDT. A second PDT was applied in case of non- or partially responding lesions 12 weeks after first PDT.|12 weeks after the second PDT, 24 after first treatment|ITT||percentage of change from baseline||Standard Deviation|Mean
634203|NCT02799069|Secondary|Change From Baseline in Total Lesion Area 3-4 Weeks After the Second Photodynamic Therapy (PDT)|the change from baseline in the lesion area of all treated lesions per subject (summation of sizes of all treated lesions) assessed 3-4 weeks after the second PDT. A second PDT was applied in case of non or partially responding lesions 12 weeks after first PDT.|3-4 weeks after the second PDT, 15-16 weeks after first treatment|ITT||percentage of change from baseline||Standard Deviation|Mean
634295|NCT02777125|Secondary|Number of Patients Requiring Ondansetron Dosing|Defined as a patient needing ondansetron for symptomatic relief of their nausea after initiating therapy in the Emergency Department.|6 hours|||Participants|||Count of Participants
634207|NCT02799069|Secondary|Complete Lesion Response Rate 12 Weeks After Last Photodynamic Therapy (PDT)|Completely cleared individual lesions 12 weeks after last PDT comprising of completely cleared individual lesions 12 weeks after the first or second PDT (a second PDT was applied in case individual lesions show no or partial response 12 weeks after first PDT).|12 weeks after the last PDT, up to 24 weeks after first treatment|ITT||percentage of lesions|num,ber of individual lesions|95% Confidence Interval|Number
634208|NCT02799069|Secondary|Complete Lesion Response Rate 3-4 Weeks After Last Photodynamic Therapy (PDT)|Completely cleared individual lesions defined at 3-4 weeks after the last PDT comprising of completely cleared individual lesions 3-4 weeks after the first and after the second PDT (a second PDT was applied in case lesions show no or partial response 12 weeks after the first PDT).|3-4 weeks after the last PDT, up to 16 weeks after first treatment|ITT||percentage of lesions|number of individual lesions|95% Confidence Interval|Number
634209|NCT02799069|Secondary|Complete Lesion Response Rate 12 Weeks After Second PDT|Completely cleared individual lesions as defined at 12 weeks after second PDT. A second PDT was applied in case the individual lesion showed no or partial response 12 weeks after first PDT.|12 weeks after the second PDT, 24 weeks after first treatment|ITT||percentage of lesions|number of individual lesions|95% Confidence Interval|Number
634210|NCT02799069|Secondary|Complete Lesion Response Rate 3-4 Weeks After the Second Photodynamic Therapy (PDT)|Completely cleared individual lesions as defined at 3-4 weeks after the second PDT. A second PDT was applied in case the individual lesion showed no or partial response12 weeks after first PDT.|3-4 weeks after the second PDT, 15-16 weeks after first treatment|ITT||percentage of lesions|number of individiual lesions|95% Confidence Interval|Number
634211|NCT02799069|Secondary|Complete Lesion Response Rate 12 Weeks After First Photodynamic Therapy (PDT)|Completely cleared individual lesions as defined at 12 weeks after the first photodynamic therapy (PDT).|12 weeks after the first PDT|ITT||percentage of lesions|number of individual lesions|95% Confidence Interval|Number
634212|NCT02799069|Secondary|Complete Lesion Response Rate 3-4 Weeks After First Photodynamic Therapy (PDT)|Completely cleared individual lesions as defined at 3-4 weeks after first photodynamic therapy (PDT)|3-4 weeks after the first PDT|ITT||percentage of lesions|number of individual lesions|95% Confidence Interval|Number
634213|NCT02799069|Secondary|Percentage of Participants With Partial Response at 12 Weeks After Last Photodynamic Therapy (PDT)|"A partial responder was defined as a subject in whom at least 75% of the treated lesions were cleared (lesions showing complete remission). This outcome measure considers partial responders at 12 weeks after last PDT.
The outcome measure combined partial responders with at least 75% of lesions cleared at 12 weeks after the first PDT and after the second PDT (a second PDT was applied in case of partial- or non-responding lesions 12 weeks after the first PDT) ."|12 weeks after the last PDT, up to 24 weeks after first treatment|ITT||percentage of patients||95% Confidence Interval|Number
634214|NCT02799069|Secondary|Percentage of Participants With Partial Response at 3-4 Weeks After Last Photodynamic Therapy (PDT)|"A partial responder was defined as a subject in whom at least 75% of the treated lesions were cleared (lesions showing complete remission). This outcome measure considers partial responders at 3-4 weeks after last PDT.
The outcome measure combined partial responders with at least 75% of lesions cleared at 3-4 weeks after the first PDT or after the second PDT (a second PDT was applied in case of partial- or non-responding lesions 12 weeks after the first PDT)."|3-4 weeks after the last PDT, up to 16 weeks after the first treatment|ITT||percentage of patients||95% Confidence Interval|Number
634215|NCT02799069|Secondary|Percentage of Participants With Partial Response at 12 Weeks After the Second Photodynamic Therapy (PDT)|"A partial responder was defined as a subject in whom at least 75% of the treated lesions were cleared (lesions showing complete remission). This outcome measure considers partial responders at 12 weeks after the second PDT.
A second PDT was applied in case of partial- or non-responding lesions 12 weeks after the first PDT."|12 weeks after the second PDT, 24 weeks after first treatment|ITT||percentage of patients||95% Confidence Interval|Number
634216|NCT02799069|Secondary|Percentage of Participants With Partial Response at 3-4 Weeks After the Second Photodynamic Therapy (PDT)|"A partial responder was defined as a subject in whom at least 75% of the treated lesions were cleared (lesions showing complete remission). This outcome measure considers partial responders at 3-4 weeks after the second PDT.
A second PDT was applied in case of partial- or non-responding lesions 12 weeks after the first PDT."|3-4 weeks after the second PDT, 15-16 weeks after first treatment|ITT||percentage of patients||95% Confidence Interval|Number
634217|NCT02799069|Secondary|Percentage of Participants With Partial Response at 12 Weeks After the First Photodynamic Therapy (PDT)|A partial responder was defined as a subject in whom at least 75% of the treated lesions were cleared (lesions showing complete remission). This outcome measure considers partial responders at 12 weeks after the first PDT.|12 weeks after the first PDT|ITT||percentage of patients||95% Confidence Interval|Number
634218|NCT02799069|Secondary|Percentage of Participants With Partial Response at 3-4 Weeks After First Photodynamic Therapy (PDT)|A partial responder was defined as a subject in whom at least 75% of the treated lesions were cleared (lesions showing complete remission). This outcome measure considers partial responders at 3-4 weeks after the first PDT.|3-4 weeks after the first PDT|ITT||percentage of patients||95% Confidence Interval|Number
634219|NCT02799069|Secondary|Percentage of Participants With Complete Response 3-4 Weeks After Last Photodynamic Therapy (PDT)|A complete responder at week 3-4 after treatment was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission). This outcome measure considered patients who were completely cleared at 3-4 weeks after the last PDT which included complete responders 3-4 weeks after the first and complete responders 3-4 weeks after the second PDT ( a second PDT was applied in case of remaining lesions 12 weeks after the first PDT).|3-4 weeks after the last PDT, up to 16 weeks after the first treatment|ITT||percentage of patients||95% Confidence Interval|Number
634220|NCT02799069|Secondary|Percentage of Participants With Complete Response 12 Weeks After Second Photodynamic Therapy (PDT)|A complete responder was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission) at 12 weeks after the second PDT. A second PDT was applied in case partial- or non-responding lesions remained 12 weeks after the first PDT.|12 weeks after the second PDT, 24 weeks after first treatment|ITT||percentage of patients||95% Confidence Interval|Number
634458|NCT02750267|Secondary|Distribution of Sensor and Meter Glucose Values (Minimum)|All subjects have CGM and handheld glucose meter output analyzed and compared between time on closed-loop system and time on usual care period.|72 hours||||||
634221|NCT02799069|Secondary|Percentage of Participants With Complete Response 3-4 Weeks After the Second Photodynamic Therapy (PDT)|A complete responder was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission) at 3-4 weeks after the second PDT. A second PDT was applied in case partial- or non-responding lesions remained 12 weeks after the first PDT.|3-4 weeks after the second PDT, 15-16 weeks after first treatment|ITT||percentage of patients||95% Confidence Interval|Number
634222|NCT02799069|Secondary|Percentage of Participants With Complete Response 12 Weeks After First Photodynamic Therapy (PDT)|A complete responder was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission) at 12 weeks after the first PDT.|12 weeks after the first PDT|ITT||percentage of patients||95% Confidence Interval|Number
634223|NCT02799069|Secondary|Percentage of Participants With Complete Response 3-4 Weeks After First Photodynamic Therapy (PDT)|A complete responder was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission) at 3-4 weeks after the first PDT.|3-4 weeks after the first PDT|ITT||percentage of patients||95% Confidence Interval|Number
634224|NCT02799069|Primary|Percentage of Participants With Complete Response 12 Weeks After the Last Photodynamic Therapy (PDT) Illuminated With Narrow Spectrum Devices Only|"Subgroup analysis of patients treated with a narrow spectrum device for PDT Illumination (~630 nm).
An overall complete responder was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission) 12 weeks after the last PDT.
The outcome measure considered complete responders who were completely cleared 12 weeks after the first PDT and responders who were completely cleared 12 weeks after the second PDT if a re-treatment was necessary (in case of partial- or non-responding lesions 12 weeks after the first PDT)"|12 weeks after the last PDT, up to 24 weeks after the first treatment|ITT||percentage of patients||95% Confidence Interval|Number
634225|NCT02799069|Primary|Percentage of Participants With Complete Response 12 Weeks After the Last Photodynamic Therapy (PDT), PP|"An overall complete responder was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission) 12 weeks after the last PDT.
The outcome measure considered complete responders who were completely cleared 12 weeks after the first PDT and responders who were completely cleared 12 weeks after the second PDT if a re-treatment was necessary (in case of partial- or non-responding lesions 12 weeks after the first PDT)"|12 weeks after the last PDT, up to 24 weeks after the first treatment|per protocol set (PP)||percentage of patients||95% Confidence Interval|Number
634226|NCT02799069|Primary|Percentage of Participants With Complete Response 12 Weeks After the Last Photodynamic Therapy (PDT), ITT|"An overall complete responder was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission) 12 weeks after the last PDT.
The outcome measure considered complete responders who were completely cleared 12 weeks after the first PDT and responders who were completely cleared 12 weeks after the second PDT if a re-treatment was necessary (in case of partial- or non-responding lesions 12 weeks after the first PDT)"|12 weeks after the last PDT, up to 24 weeks after the first treatment|Intent-to-treat (ITT)||percentage of patients||95% Confidence Interval|Number
634227|NCT02796092|Secondary|Need for Re-embolization|Scheduled re-embolization due to incomplete occlusion|12 months|||participants|||Number
634228|NCT02796092|Secondary|Complications|Toral number of events related to the procedure in the follow-up (1 year)|12 months|||events|||Number
634229|NCT02796092|Secondary|Complications|Total number of events during the procedure|intraoperative|||minor events|||Number
634230|NCT02796092|Secondary|Procedure Radiation Dose (AK)|AK, total air kerma of the intervention (in mGy), recorded by fluoroscopy equipment|Intraoperative|||mGy||Standard Deviation|Mean
634231|NCT02796092|Secondary|Procedure Radiation Dose (DAP)|DAP, dose area product of the intervention, (in mGy*cm^2), recorded by fluoroscopy equipment|Intraoperative|||mGy*cm^2||Standard Deviation|Mean
634232|NCT02796092|Secondary|Fluoroscopy Time|Total fluoroscopy time, recorded by the equipment (in minutes)|Intraoperative|||minutes||Standard Deviation|Mean
634233|NCT02796092|Secondary|Total Intervention Duration|Total time length of the procedure, from puncture to compression (in minutes)|Intraoperative|||minutes||Standard Deviation|Mean
634234|NCT02796092|Secondary|Cost of Treatment|Cost of the differential devices used in each treatment procedure, assuming the same cost for the rest of the procedure, other material and hospital stay.|Intraoperative|||US Dollars||Standard Deviation|Mean
634235|NCT02796092|Secondary|Number of Devices Used|Number of coils and number of vascular plugs used in each procedure|intraoperative|||devices||Standard Deviation|Mean
634236|NCT02796092|Secondary|Satisfaction With the Procedure|"Overall satisfaction with the procedure via telephone survey (scaled from 0 to 9).
Patients answered just one question. Are you satisfied with the procedure? Being 0 = Completely unsatisfied, I regret having undergone a embolization procedure 9=Totally satisfied with the procedure, everything was perfect, I would recommend it to anyone with the same problem."|12 months|||units on a scale||Standard Deviation|Mean
634237|NCT02796092|Secondary|Improvement of Dysmenorrhea|Disappearance or improvement of dysmenorrhea assessed by direct questioning before the procedure and 12 months after the procedure (YES/NO)|12 months|Population presenting pre-treatment dysmenorrhea||participants|||Number
634238|NCT02796092|Secondary|Improvement of Urinary Urgency|Disappearance or improvement of urinary urgency assessed by direct questioning before the procedure and 12 months after the procedure (YES/NO)|12 months|Population presenting pre-treatment urinary urgency||participants|||Number
634239|NCT02796092|Secondary|Improvement of Dyspareunia|Disappearance or improvement of dyspareunia assessed by direct questioning before the procedure and 12 months after the procedure (YES/NO)|12 months|Population presenting pre-treatment dyspareunia||participants|||Number
634240|NCT02796092|Primary|Change in Pain Scale|"Reduction of 4 points or more between subjective pain assessed by VAS prior to procedure (-4, -5,- 6, -7,-8,-9).
VAS= visual analogue scale: it is a subjective pain scale, scored from 1 to 10 (1 no pain; 10 worst pain possible)"|12 months|Population presenting pre-treatment pain (more than 1 in VAS)||participants|||Number
634241|NCT02792049|Secondary|Number of Participants Who Preferred the Modified Bag Valve Mask (BVM)|Each subject provides a binary response as to whether he/she overall prefers using the modified BVM instead of the conventional BVM.|Within 10 minutes of study completion|||participants|||Number
634459|NCT02750267|Secondary|Distribution of Sensor and Meter Glucose Values (Maximum)|All subjects have CGM and handheld glucose meter output analyzed and compared between time on closed-loop system and time on usual care period.|72 hours||||||
634242|NCT02792049|Secondary|Modified Bag Valve Mask (BVM) Willingness to Use in Emergency Situation|Subject reported willingness to use the modified BVM in a real life emergency situation as measured on a Likert scale ranging 1 (not at all willing to use) to 5 (very willing to use).|Within 10 minutes of study completion|||Units on a scale||Inter-Quartile Range|Median
634243|NCT02792049|Secondary|Modified Bag Valve Mask (BVM) Better Seal Formation|Subjects response using a Likert scale (1-5) regarding their perceptions of whether the modified BVM forms a better seal compared to a standard BVM: 1 (much worse seal formation) to 5 (much better seal formation).|Within 10 minutes of study completion|||Units on a scale||Inter-Quartile Range|Median
634244|NCT02792049|Secondary|Modified Bag Valve Mask (BVM) Ease of Use|Likert scale measuring subject's perceived ease of use of the modified BVM device from not at all easy to use (1) to very easy to use (5).|Within 10 minutes of study completion|||Units on a scale||Inter-Quartile Range|Median
634245|NCT02792049|Primary|Mean Received Tidal Volume|Each participant was asked to provide BVM ventilation using the assigned devices at a rate of 10 breaths per minute for 3 minutes for a total of 30 breaths. Tidal volume of each delivered breath was recorded in milliliters|3 minutes|||milliliters||Standard Deviation|Mean
634246|NCT02791659|Primary|Effective Radiation Dose|The effective radiation which represents equivalent dose to eye lens of each personnel were compared between 2 groups.|Immediate after procedure|||mSv||Inter-Quartile Range|Median
634247|NCT02791269|Secondary|Number of Participants With HBeAg Seroconversion|HBeAg seroconversion for HBeAg positive participants was defined as the loss of HBeAg (a negative result for HBeAg) and the presence of anti-HBe (a positive result for anti-HBe).|Week 48 (end of treatment) and Week 72 (end of follow-up)|"ITT population. Only HBeAg positive participants was planned to be reported. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified participants with evaluable data for a specified time point."||participants|||Number
634248|NCT02791269|Secondary|Number of Participants With Normalization of Alanine Aminotransferase (ALT) Level|ALT is an enzyme found mainly in liver and is measured to check if the liver is damaged or diseased. In case of liver damage or disease, the liver releases ALT into the blood stream and the ALT level increases. Normal ALT level = less than upper limit of normal (40 units per liter).|Week 48 (end of treatment) and Week 72 (end of follow-up)|"ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified participants with evaluable data for a specified time point."||participants|||Number
634249|NCT02791269|Secondary|Number of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion|HBsAg seroconversion was defined as the absence of HBsAg (a negative result for HBsAg) and the presence of anti-HBs (a positive result for anti-HBs). Both HBeAg positive and negative participants were HBsAg positive at baseline and absence of HBsAg (seroconversion) was analyzed.|Week 48 (end of treatment) and Week 72 (end of follow-up)|"ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified participants with evaluable data for a specified time point."||participants|||Number
634250|NCT02791269|Secondary|Number of Participants With HBV-DNA <400 Copies/mL|HBV-DNA was assessed in plasma samples using quantitative Roche PCR or Taqman tests.|Week 48 (end of treatment) and Week 72 (end of follow-up)|"ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified participants with evaluable data for a specified time point."||participants|||Number
634251|NCT02791269|Primary|Number of Participants With HBV-DNA <20,000 Copies/mL|HBV-DNA was assessed in plasma samples using quantitative Roche PCR or Taqman tests.|End of 24-weeks follow-up (Week 72)|"ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome."||participants|||Number
634252|NCT02791269|Primary|Number of HBeAg Positive Participants With Hepatitis B Virus-deoxy Ribonucleic Acid (HBV-DNA) Less Than (<) 100,000 Copies Per Milliliter (Copies/mL)|HBV-DNA was assessed in plasma samples using quantitative Roche polymerase chain reaction (PCR) or Taqman tests.|End of 24-weeks follow-up (Week 72)|"Intent-to-treat (ITT) population included all participants who received at least one dose of study medication and had one subsequent post baseline assessment. Here, number of participants analyzed signified those participants who were evaluable for this outcome."||participants|||Number
634253|NCT02790281|Primary|Exploratory: Levels of C-reactive Protein (CRP)|Blood sample was taken for analysis of levels of CRP.|At Day 1|All eligible subjects with CRP >5 mg/L||mg/L||Full Range|Median
634254|NCT02790281|Primary|Exploratory: Levels of IL-6|Blood sample was taken for analysis of levels of IL-6.|At Day 1|All eligible subjects with CRP >5 mg/L||pg/mL||Full Range|Median
634255|NCT02790281|Primary|Exploratory: Levels of IL-6/sIL-6R Complex|Blood sample was taken for analysis of levels of IL-6/sIL6-R complex.|At Day 1|All eligible subjects with CRP >5 mg/L.||pg/mL||Full Range|Median
634256|NCT02788357|Secondary|Transcranial Magnetic Stimulation||Score change after 10 days of intervention compared to baseline; Score change after 1-month after the intervention compared to baseline|This data is not available at this time, as a relocation occurred during the project. Data collected at the previous institution used different software and stored the data in a different format than is currently used. Therefore, reconciliation of this data is being attempted at this time.|||||
634257|NCT02788357|Secondary|Change in Wolf Motor Function Test (WMFT)|Score at post-intervention minus baseline, score at 1-month follow-up minus baseline. Each task is scored as amount of time taken to complete a task, which may range from just over 0 to 120 seconds. If the subject is unable to complete the task within 120 seconds, a score of 121 seconds is given. The scores from the 15 individual tasks are averaged, then the log is taken, resulting in the overall score. Therefore, the larger the score, the longer required to perform the tasks. Negative changes in score indicate that a subject, on average, was able to complete the tasks faster at post-intervention or at 1-month follow-up than at baseline.|baseline, post-intervention, 1-month follow-up|3 subjects in the Atomoxetine group were lost to follow-up.||log(seconds)||95% Confidence Interval|Mean
634258|NCT02788357|Secondary|Change in Action Arm Research Test (ARAT)|Score at post-intervention minus baseline, score at 1-month follow-up minus baseline. The score is calculated by summing the scores for 19 individual tasks. The possible scores range from 0 to 57, with higher scores indicating better performance.|baseline, post-intervention, 1-month follow-up|3 subjects in the Atomoxetine group were lost to follow-up.||units on a scale||95% Confidence Interval|Mean
639961|NCT02368314|Secondary|Frequency of “Big” and Clinically Significant “Small” Bleedings||During the treatment period (14 days)||||||
634259|NCT02788357|Primary|Change in Fugl Meyer Assessment|Score after intervention minus baseline score, score at 1-month follow-up minus baseline score. The possible scores range from 0 to 66, with 66 indicating the best performance.|baseline, post-intervention, 1-month follow-up|3 subjects in Atomoxetine group were lost to follow-up.||units on a scale||95% Confidence Interval|Mean
634260|NCT02788097|Primary|Biochemical Pregnancy|>30IU/L of serum βhCG on day 14 of cycle|1 year|||percentage of participants|||Number
634264|NCT02786004|Secondary|Number of Subjects Experiencing a Device Related Adverse Events, Serious Adverse Event, Unanticipated Device Effect and Device Defects by Overall Occurrence.|Overall clinical image quality was assessed as acceptable for 100% of the NextGen FFDM and DBT image sets evaluated in this study, and there were no AEs, SAEs, or UADEs reported in this study.|Through study completion, approximately 3 months||06/2017||||
634265|NCT02786004|Primary|Image Quality Assessment by MQSA Qualified Radiologist to Access Sufficiently Acceptable Image Quality for Use in Clinical Mammography.|Overall clinical image quality was assessed as acceptable for 100% of the NextGen FFDM and DBT image sets evaluated in this study.|At enrollment completion approximately 3 months post initiation|||Participants|||Count of Participants
634266|NCT02784925|Primary|Subcutaneous Fat in Steatosis Patients||up to 6 months|fatty liver patients||cm^3||95% Confidence Interval|Mean
634267|NCT02780622|Secondary|Percentage of Participants With Adverse Events|An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Up to Day 26|All enrolled participants.||percentage of participants|||Number
634268|NCT02780622|Secondary|Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to 12 Hours (AUC0-12h) for R- and S- Warfarin|R- and S-warfarin are two molecular versions of warfarin with slightly different structures. The reported concentrations were normalized by dividing the AUC values (hours multiplied by nanograms, per milliliter) by the individual average dose (milligrams).|Pre-dose; 1, 2, 4, 8, 12, 24 hours post-dose on Day 5|All enrolled participants.||h*ng/mL/mg||Standard Deviation|Mean
634269|NCT02780622|Secondary|Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to 12 Hours (AUC0-12h) for Oseltamivir and Oseltamivir Carboxylate||Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post-dose on Day 1 and 5; 18 and 24 hours post-dose on Day 5|All enrolled participants.||h*ng/mL||Standard Deviation|Mean
634270|NCT02780622|Secondary|Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to 24 Hours (AUC0-24h) for R- and S- Warfarin|R- and S-warfarin are two molecular versions of warfarin with slightly different structures. The reported concentrations were normalized by dividing the AUC values (hours multiplied by nanograms, per milliliter) by the individual average dose (milligrams).|Pre-dose; 1, 2, 4, 8, 12, 24 hours post-dose on Day 5|All enrolled participants.||h*ng/mL/mg||Standard Deviation|Mean
634271|NCT02780622|Secondary|Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to 24 Hours (AUC0-24h) for Oseltamivir and Oseltamivir Carboxylate||Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18 and 24 hours post-dose on Day 5|All enrolled participants.||h*ng/mL||Standard Deviation|Mean
634272|NCT02780622|Secondary|Maximum Plasma Concentration (Cmax) for R- and S- Warfarin|R- and S-warfarin are two molecular versions of warfarin with slightly different structures. The reported concentrations were normalized by dividing the Cmax values (nanograms per milliliter) by the individual average dose (milligrams).|Pre-dose; 1, 2, 4, 8, 12, 24 hours post-dose on Day 5|All enrolled participants.||Nanogram/milliliter/milligram (ng/mL/mg)||Standard Deviation|Mean
634273|NCT02780622|Secondary|Maximum Plasma Concentration (Cmax) for Oseltamivir and Oseltamivir Carboxylate||Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post-dose on Day 1 and 5; 18 and 24 hours post-dose on Day 5|All enrolled participants.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
634274|NCT02780622|Secondary|Oral Plasma Clearance (CL/F) for R- and S- Warfarin||Pre-dose; 1, 2, 4, 8, 12, 24 hours post-dose on Day 5|All enrolled participants.||liters per hour (L/h)||Standard Deviation|Mean
634275|NCT02780622|Secondary|Oral Plasma Clearance (CL/F) for Oseltamivir||Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post-dose on Day 1 and 5; 18 and 24 hours post-dose on Day 5|All enrolled participants.||liters per hour (L/h)||Standard Deviation|Mean
634276|NCT02780622|Secondary|Terminal Half-life (t½) for R- and S- Warfarin||Pre-dose; 1, 2, 4, 8, 12, 24 hours post-dose on Day 5|All enrolled participants.||hours||Standard Deviation|Mean
634277|NCT02780622|Secondary|Terminal Half-life (t½) for Oseltamivir and Oseltamivir Carboxylate|Oseltamivir carboxylate is an active metabolite of oseltamivir.|Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post-dose on Day 1 and 5; 18 and 24 hours post-dose on Day 5|All enrolled participants.||hours||Standard Deviation|Mean
634278|NCT02780622|Secondary|Time to Maximum Plasma Concentration (Tmax) for R- and S- Warfarin||Pre-dose; 1, 2, 4, 8, 12, 24 hours post-dose on Day 5|All enrolled participants.||hours||Full Range|Median
634279|NCT02780622|Secondary|Time to Maximum Plasma Concentration (Tmax) for Oseltamivir and Oseltamivir Carboxylate|Oseltamivir carboxylate is an active metabolite of oseltamivir.|Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post-dose on Day 1 and 5; 18 and 24 hours post-dose on Day 5|All enrolled participants.||hours||Full Range|Median
634280|NCT02780622|Primary|Change From Baseline in Plasma Concentration of Vitamin K1|Vitamin K1 is required by proteins involved in blood clotting. Food interaction with warfarin can lead to decreases in Vitamin K1 in plasma. An increase in vitamin K1 signifies enhancement of warfarin's anticoagulant effect.|Pre-dose on Day 1 and 24 hours post-dose on Day 5|All enrolled participants.||nanogram per liter (ng/L)||Full Range|Mean
634281|NCT02780622|Primary|Time to Reach Maximum Change From Baseline in Factor VII Activity (Tmax)|Factor VIIa is a protein that causes blood to clot. A decrease in factor VIIa activity signifies enhancement of warfarin's anticoagulant effect.|Pre-dose on Day 1, 24 hours (Day 2), 48 hours (Day 3), 72 hours (Day 4), and 96 hours (Day 5)|All enrolled participants with available data.||hours||Full Range|Median
634282|NCT02780622|Primary|Change From Baseline in Maximum Observed Effect (Emax) in Factor VII Activity|Factor VIIa is a protein that causes blood to clot. A decrease in factor VIIa activity signifies enhancement of warfarin's anticoagulant effect. kIU/L = 1000 * international units per liter.|Pre-dose on Day 1, 24 hours (Day 2), 48 hours (Day 3), 72 hours (Day 4), and 96 hours (Day 5)|All enrolled participants with available data.||kIU/L||Full Range|Mean
634283|NCT02780622|Primary|Area Under the Plasma Effect-time Curve Over 96 Hours (AUEC[0-96 h]) for Factor VII Activity|Factor VIIa is a protein that causes blood to clot, and low levels in the blood can cause excessive or prolonged bleeding after an injury or surgery. The net AUEC(0-96 h) was calculated using the linear trapezoidal rule; this was the area under the effect-time curve and above the baseline minus the area above the curve and below the baseline during the 5-day period. A decrease in factor VIIa activity signifies enhancement of warfarin's anticoagulant effect. kIU/L = 1000 * international units per liter.|Pre-dose on Day 1, 24 hours (Day 2), 48 hours (Day 3), 72 hours (Day 4), and 96 hours (Day 5)|All enrolled participants with available data.||hours*kIU/L||Full Range|Mean
634284|NCT02780622|Primary|Time to Reach Maximum Change From Baseline in International Normalized Ratio (INR) (Tmax)|INR is calculated based on results of a prothrombin time (PT) test (which measures how long it takes blood to clot) and is used to monitor individuals who are being treated with the blood-thinning medication (anticoagulant) warfarin. An increase in INR signifies enhancement of warfarin's anticoagulant effect.|Pre-dose on Day 1, 24 hours (Day 2), 48 hours (Day 3), 72 hours (Day 4), and 96 hours (Day 5)|All enrolled participants.||hours||Full Range|Median
634285|NCT02780622|Primary|Change From Baseline in Maximum Observed Effect (Emax) of International Normalized Ratio (INR)|INR is calculated based on results of a prothrombin time (PT) test (which measures how long it takes blood to clot) and is used to monitor individuals who are being treated with the blood-thinning medication (anticoagulant) warfarin. An increase in INR signifies enhancement of warfarin’s anticoagulant effect.|Pre-dose on Day 1, 24 hours (Day 2), 48 hours (Day 3), 72 hours (Day 4), and 96 hours (Day 5)|All enrolled participants.||ratio||Full Range|Mean
634286|NCT02780622|Primary|Area Under the Plasma Effect-time Curve Over 96 Hours (AUEC[0-96 h]) for International Normalized Ratio (INR)|INR is calculated based on results of a prothrombin time (PT) test (which measures how long it takes blood to clot) and is used to monitor individuals who are being treated with the blood-thinning medication (anticoagulant) warfarin. The net AUEC(0-96 h) was calculated using the linear trapezoidal rule; this was the area under the effect-time curve and above the baseline minus the area above the curve and below the baseline during the 5-day period. An increase in INR signifies enhancement of warfarin’s anticoagulant effect.|Pre-dose on Day 1, 24 hours (Day 2), 48 hours (Day 3), 72 hours (Day 4), and 96 hours (Day 5)|All enrolled participants.||hours*ratio||Full Range|Mean
634287|NCT02777268|Secondary|Number of Participants With Treatment-related Adverse Events (TEAEs) as Assessed by Medical Dictionary for Regulatory Activities (MedDRA) Dictionary, Version 16.0.|To assess the safety and tolerability of Infacort® throughout the study. For a full list of TEAEs per arm, please refer to the Adverse Events section.|1 day|||TEAEs|||Number
634288|NCT02777268|Secondary|Area Under the Curve (AUC0-t) of Infacort at Doses of 0.5, 2, 5 and 10 mg|To determine the dose proportionality for Infacort® at doses of 0.5 mg, 2 mg, 5 mg and 10 mg.|1 day|||H*nmol/L||Geometric Coefficient of Variation|Geometric Mean
634289|NCT02777268|Secondary|Time to Maximum Plasma Concentration (Tmax) of Infacort at Doses of 0.5, 2, 5 and 10 mg|To determine the dose proportionality for Infacort® at doses of 0.5 mg, 2 mg, 5 mg and 10 mg.|-1h, -0.5h, 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 6.5h, 7h, 7.5h, 8h, 9h, 10h, 11h, 12h|||Hours||Standard Deviation|Median
634290|NCT02777268|Secondary|Maximum Plasma Concentration (Cmax) of Infacort at Doses of 0.5, 2, 5 and 10 mg|To determine the dose proportionality for Infacort® at doses of 0.5 mg, 2 mg, 5 mg and 10 mg.|-1h, -0.5h, 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 6.5h, 7h, 7.5h, 8h, 9h, 10h, 11h, 12h|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
634291|NCT02777268|Primary|Area Under the Curve (AUC0-t) of Infacort vs Hydrocortisone|To compare the AUC0-t of Infacort® versus immediate-release hydrocortisone in a single dose of 10 mg. AUC0-t represents the total exposure to drug over time, hence the reporting of a single value below.|-1h, -0.5h, 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 6.5h, 7h, 7.5h, 8h, 9h, 10h, 11h, 12h|Two subjects were excluded from the Infacort 10mg analysis population due to inadequate endogenous cortisol suppression prior to dosing.||hr*nmol/L||Geometric Coefficient of Variation|Geometric Mean
634292|NCT02777268|Primary|Time to Reach the Maximum Plasma Concentration (Tmax) of Infacort vs Hydrocortisone|To compare the Tmax of Infacort® versus immediate-release hydrocortisone in a single dose of 10 mg.|-1h, -0.5h, 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 6.5h, 7h, 7.5h, 8h, 9h, 10h, 11h, 12h|Two subjects were excluded from the Infacort 10mg analysis population due to inadequate endogenous cortisol suppression prior to dosing.||Hour||Standard Deviation|Median
634293|NCT02777268|Primary|Maximum Plasma Concentration (Cmax) of Infacort vs Hydrocortisone|To compare the Cmax of Infacort® versus immediate-release hydrocortisone in a single dose of 10 mg.|-1h, -0.5h, 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 6.5h, 7h, 7.5h, 8h, 9h, 10h, 11h, 12h|Two subjects were excluded from the Infacort 10mg analysis population due to inadequate endogenous cortisol suppression prior to dosing.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
638747|NCT02429258|Secondary|Change in the 24-hour Mean Ampitude of Glucose Excursions (MAGE) From Baseline to Week 4||Baseline to Week 4|||mg/dL||Standard Error|Least Squares Mean
634296|NCT02777125|Secondary|Number of Patients With Tachycardia After Treatment|Defined as anytime after initiation of therapy when the patient's heart rate exceeded age adjusted normal sinus rhythm heart rates for their age. Not uncommonly, patient's experience tachycardia as an unintended side effect of receiving albuterol. Tachycardia can result in a patient requiring further observation in the Emergency department and therefore increasing Emergency Department length of stay. We want to determine if indeed tachycardia is unavoidable, or if its presence suggests that patients are receiving too much albuterol or if albuterol is being given by the wrong appliance.|6 hours|||Participants|||Count of Participants
634297|NCT02777125|Secondary|Emergency Department Length of Stay|Emergency department length of stay is defined as the point of time when the patient checked into the Emergency Department to the time of final disposition.|6 hours|||minutes||Standard Deviation|Mean
634298|NCT02777125|Primary|Number of Participant's Admitted to the Hospital for Further Treatment|Patient disposition is measured as subjects requiring further treatment and being admitted to hospital. We record the number of patients in each cohort that required admission to the hospital after being evaluated and treated in the Emergency Department.|6 hours|||Participants admitted to the Hospital|||Number
634299|NCT02774278|Secondary|Percentage of Participants With Clinical Benefit (CR, PR, or Stable Disease [SD] for at Least 12 Weeks After Study Entry) Using RECIST|Clinical benefit was defined as either a CR, PR, or SD prior to failure (disease progression, death from any cause, or a second malignancy). CR: complete disappearance on magnetic response imaging of all enhancing tumor and mass effect on a stable or decreasing dose of dexamethasone (or only receiving adrenal replacement doses) accompanied by a stable or improving neurologic examination that was maintained for at least 12 weeks. PR: greater than or equal to 50% reduction in tumor size by bi-dimensional measurement on a stable or decreasing dose of dexamethasone accompanied by a stable or improving neurologic examination that was maintained for at least 12 weeks. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference smallest sum of longest dimensions since treatment started associated to non-progressive disease response for non-target lesions. PD: unequivocal progression of existing non-target lesions.|Baseline until disease progression, unacceptable toxicity or death, evaluated up to 4 years|Analysis population included all enrolled participants.||percentage of participants||95% Confidence Interval|Number
634300|NCT02774278|Secondary|Percentage of Participants With Overall Response of Complete Response (CR) or Partial Response (PR) Using Response Evaluation Criteria in Solid Tumors (RECIST)|Tumor response was defined as either a CR or a PR prior to failure (disease progression, death from any cause, or a second malignancy). CR was defined as the complete disappearance on magnetic response imaging of all enhancing tumor and mass effect on a stable or decreasing dose of dexamethasone (or only receiving adrenal replacement doses) accompanied by a stable or improving neurologic examination that was maintained for at least 12 weeks. PR was defined as a greater than or equal to 50 percent (%) reduction in tumor size by bi-dimensional measurement on a stable or decreasing dose of dexamethasone accompanied by a stable or improving neurologic examination that was maintained for at least 12 weeks.|Baseline until disease progression, unacceptable toxicity or death, evaluated up to 4 years|Analysis population included all enrolled participants.||percentage of participants||95% Confidence Interval|Number
634301|NCT02774278|Primary|Number of KRAS Mutation Participants Who Achieved Clinical Benefit|Affymetrix gene expression profiles were primarily analyzed to identify differentially expressed genes between the participants who derived clinical benefit status and those who did not. Analysis was performed using a multivariate linear model (with clinical benefit status, histology, ethnicity, sex, RNA integrity number (RIN), smoking status and stage as predictors), and a False Discovery Rate criteria of below 0.3 as cut-off. Number of participants with KRAS gene mutation and who achieved clinical benefit status was reported. Clinical benefit is defined in the Outcome Measure 5.|Baseline until disease progression, unacceptable toxicity or death, evaluated up to 4 years|PAS participants who had KRAS mutation at baseline were included in this analysis.||participants|||Number
634302|NCT02774278|Primary|Number of Epidermal Growth Factor Receptor (EGFR) Mutation Participants Who Achieved Clinical Benefit|Affymetrix gene expression profiles were primarily analyzed to identify differentially expressed genes between the participants who derived clinical benefit status and those who did not. Analysis was performed using a multivariate linear model (with clinical benefit status, histology, ethnicity, sex, RNA integrity number (RIN), smoking status and stage as predictors), and a False Discovery Rate criteria of below 0.3 as cut-off. Number of participants with EGFR mutation (L858R/ exon 19 deletion) and who achieved clinical benefit status was reported. Clinical benefit is defined in the Outcome Measure 5.|Baseline until disease progression, unacceptable toxicity or death, evaluated up to 4 years|PAS participants who had EGFR mutation at baseline were included in this analysis.||participants|||Number
634303|NCT02774278|Primary|Number of Differentially Expressed Genes Associated With Clinical Benefit|Affymetrix gene expression profiles were primarily analyzed to identify differentially expressed genes between the participants who derived clinical benefit status and those who did not. Analysis was performed using a multivariate linear model (with clinical benefit status, histology, ethnicity, sex, RNA integrity number (RIN), smoking status and stage as predictors), and a False Discovery Rate criteria of below 0.3 as cut-off. Clinical benefit is defined in the Outcome Measure 5.|Baseline until disease progression, unacceptable toxicity or death, evaluated up to 4 years|Primary analysis set (PAS) included all participants who provided evaluable tissue samples and were included in the primary Affymetrix efficacy analysis.||genes|||Number
634304|NCT02773758|Secondary|Change From Baseline in Tactile Threshold at Day 7 and Day 14|A tactile stimulus was administered using a constant pressure probe (Yeaple Probe). Response to this stimulus was evaluated as tactile threshold. The constant pressure probe allowed the examiner to vary the force applied to the dentine surface from 10 g to an upper threshold of 80 g in increments of 10 g. The tactile threshold is the maximum pressure applied without the participant's reporting pain or discomfort. The greater the tactile threshold, the less sensitive the tooth.|Baseline, Day 7 and Day 14|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received at least one dose of the study treatment and provided at least one post-baseline assessment of efficacy.||gram (g)||Standard Deviation|Mean
634326|NCT02767765|Secondary|Time to Response|Time to response was defined as the time between the start of treatment and the increase in hemoglobin level >1 g/dL compared to baseline hemoglobin level. Time to response was estimated using Kaplan Meier method.|Baseline up to Week 4|ITT analysis population||days||95% Confidence Interval|Median
634305|NCT02773758|Secondary|Change From Baseline in Schiff Sensitivity Score at Day 7|Schiff Sensitivity Score is an examiner based index, was scored immediately following administration of the evaporative air stimulus by directing a maximum one second application of air from a dental air syringe to the exposed dentine surface from a distance of approximately 1 cm. The examiner indicated the participant’s response to the evaporative air stimulus, after the stimulation of each individual tooth, using the Schiff sensitivity scale as follows: 0= participant does not respond to air stimulation; 1= participant responds to air stimulus but does not request discontinuation of stimulus; 2= participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.|Baseline, Day 7|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received at least one dose of the study treatment and provided at least one post-baseline assessment of efficacy.||score on a scale||Standard Deviation|Mean
634306|NCT02773758|Primary|Change From Baseline in Schiff Sensitivity Score at Day 14|Schiff Sensitivity Score is an examiner based index, was scored immediately following administration of the evaporative air stimulus by directing a maximum one second application of air from a dental air syringe to the exposed dentine surface from a distance of approximately 1 cm. The examiner indicated the participant’s response to the evaporative air stimulus, after the stimulation of each individual tooth, using the Schiff sensitivity scale as follows: 0= participant does not respond to air stimulation; 1= participant responds to air stimulus but does not request discontinuation of stimulus; 2= participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.|Baseline, Day 14|Analysis for this outcome was conducted on Intent-to-treat (ITT) population which included all participants who were randomized, received at least one dose of the study treatment and provided at least one post-baseline assessment of efficacy.||score on a scale||Standard Deviation|Mean
634307|NCT02772666|Primary|Number of Participants With Detected Relative Afferent Pupillary Defect (RAPD)|"The instrument illuminated the eyes alternatively and took images and recorded pupillary reflex to this light stimulation.
All of 44 patients were examined with two methods, SFT and O Glass. SFT method: The well known manual method to diagnose RAPD. O glass method:The device consists of camera and light sources.The red light was on and off for a 5 second interval. Then the white light was on for right eye and 3 seconds later the system captured an image. After 0.5 second the right light was off and the left light turned on, 3 seconds later the image was captured. The images were processed and analyzed using computerized software."|up to 6 months|||participants|||Number
634308|NCT02770625|Other Pre-specified|Assessment of AEs, Vital Signs, Physical Examination, and Electrocardiogram (ECG)||Screening to Visit14 (Week 26)||||||
634309|NCT02770625|Secondary|Change in Bone Mineral Density||from baseline to Week 24|||g/cm^2||Standard Deviation|Mean
634310|NCT02770625|Secondary|Skeletal Status Improvement|The number of participant who have the skeletal status diagnosed as Osteosclerosis|from baseline to Week 24|||Participants|||Count of Participants
634311|NCT02770625|Secondary|Acid Phosphatase (ACP) Level (U/L)||from baseline to Week 24|||U/L||Standard Deviation|Mean
634312|NCT02770625|Secondary|Chemokine Ligand (CCL-18) Level [ng/mL]||from baseline to Week 24|||ng/mL||Standard Deviation|Mean
634313|NCT02770625|Secondary|Chitotriosidase Level (Nmol/mL/hr)||from baseline to Week 24|||nmol/mL/hr||Standard Deviation|Mean
634314|NCT02770625|Secondary|Angiotensin-converting Enzyme Level||from baseline to Week 24|||U/L||Standard Deviation|Mean
634315|NCT02770625|Secondary|Liver Volume||from baseline to Week 24|||Milliliters||Standard Deviation|Mean
634316|NCT02770625|Secondary|Spleen Volume||from baseline to Week 24|||Milliliters||Standard Deviation|Mean
634317|NCT02770625|Secondary|Platelet Counts [10^3 Platelets/uL]||from baseline to Week 24|||10^3 platelets/uL||Standard Deviation|Mean
634318|NCT02770625|Primary|The Difference in Hemoglobin Concentration [g/dL]||from baseline to Week 24|||g/dL||Standard Deviation|Mean
634319|NCT02767843|Secondary|Complete Response|snoring for < 5% of total sleep tim|one night||||||
634320|NCT02767843|Primary|Adverse Events|all adverse events|one night|All four participants were analyzed for adverse events. No participants could be analyzed for efficacy outcomes because of technical difficulties with the measurement instruments.||Participants|||Count of Participants
634321|NCT02767843|Primary|Response|snoring decreased by <50% from baseline|one night|Technical problems with the measurement instruments meant that no analyzable data were collected.|||||
634322|NCT02767765|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Anemia (FACT-An) Questionnaire Score at Week 4|FACT-An comprises of 4 subscales of 27-item (FACT-General scale [FACT-G]): physical well-being, social/family well-being, emotion well-being, functional well-being, and an additional concerns anemia subscale. All questions are rated on a scale from 0 to 4, where higher scores indicate more impact on quality of life. The physical well-being subscale consists of 7 questions with score range from 0-28; social/family well-being subscale consists of 7 questions with score range from 0-28; emotion well-being subscale consists of 6 questions with score range from 0-24; functional well-being subscale consists of 7 questions with score range from 0-28; anemia subscale consist of 20 questions with score range from 0-80. Total FACT-An score ranges from 0-188.|Baseline, Week 4|"All enrolled participants who completed the questionnaire at baseline were included in the analysis. Here, n represents number of participants evaluable for the specified category."||units on a scale||Standard Deviation|Mean
634323|NCT02767765|Secondary|Percentage of Participants Who Required Transfusion||Baseline, Week 2, Week 4|ITT analysis population||percentage of participants|||Number
634324|NCT02767765|Secondary|Percentage of Participants With No Response to Treatment After 4 Weeks of Study Treatment|"No Response to treatment after 4 weeks was defined as meeting any of the following criteria: <1 g/dL increase in hemoglobin level or hemoglobin level <8.5 g/dL or need of transfusion. If a participant had an increase in hemoglobin level of >1 g/dL but required transfusion then the participant is considered as Non- Responder."|Week 4|ITT analysis population||percentage of participants|||Number
634325|NCT02767765|Secondary|Percentage of Participants With Response to Treatment After 2 Weeks of Study Treatment|Response to treatment after 2 weeks of treatment was defined as presence of any of the following criteria: reticulocytes >40000 per microliter or >25% increase in soluble transferrin receptor or >0.5 g/dL increase in hemoglobin level.|Week 2|ITT analysis population||percentage of participants|||Number
634327|NCT02767765|Primary|Percentage of Participants With Response to Treatment|Response to treatment was defined as an increase of greater than (>) 1 gram per deciliter (g/dL) in hemoglobin level (irrespective of the need of transfusion) from Baseline value at Week 4.|Week 4|The intent-to-treat (ITT) analysis population included all enrolled participants who received study medication for at least 2 weeks.||percentage of participants|||Number
634328|NCT02766400|Primary|Differences in Independence With Activities of Daily Living (Functional Independence Measure) Between Groups Over Time|"Differences between groups in mean independence scores (computed from Functional Independence Measure total scores) over time.
The Functional Independence Measure contains 18 items with a total score ranging from 18-126 is obtained (18=complete dependence/total assistance with basic self-care and mobility activities; 126=complete independence with basic self-care and mobility activities). Total scores were calculated for each participant at baseline, discharge, month 3, month 6, and month 12, and mean total scores for each group were calculated at each time point. Differences in mean scores were examined between groups over time with mixed model analyses."|Baseline, rehab discharge, month 3, month 6, month 12|||units on a scale||Standard Error|Mean
634329|NCT02766244|Primary|Perfusion of Burned Area|Perfusion as measured by ICG Fluorescence|5 days|||% perfusion compared to normal skin|||Number
634330|NCT02765269|Secondary|Karnofsky Performance Score Evaluation|"The Karnofsky performance score runs from 100 to 0, where 100 is perfect health and 0 is death. Higher values represent better outcomes.The investigators will compare average score between trial group and control group."|2 weeks|||scores on a scale||Standard Deviation|Mean
634331|NCT02765269|Secondary|Users' Satisfaction (Questionnaire)|Patients will be asked to complete a questionnaire after patients use it for 2 weeks.|2 weeks|||participants|||Number
634332|NCT02765269|Secondary|Pain Management|"Numerical rating scale allows a person to describe the intensity of his/her pain as a number usually ranging from 0 to 10, where 0 means no pain and 10 means pain as bad as it could be. Higher values means worse outcomes. The investigators will compare average pain score assessed by numerical rating scale at the end of the trial period."|2 weeks|||scores on a scale||Standard Deviation|Mean
634333|NCT02765269|Primary|Feasibility of Mobile Application Assessed by Observing the Number of Daily Pain Assessments Recorded Among Patients|The primary objective is to demonstrate that this mobile application is feasible by observing the numbers of daily pain assessment among patients.|2 weeks|||pain assessments per day||Standard Deviation|Mean
634334|NCT02763189|Secondary|Performance Score|The performance score is obtained form the performance Score Sheet that includes 15 actions, 1 point is given for each completed action. The minimum score is 0, the maximum score is 15. Higher scores relate to better performance.|immediately after the procedure|||units on a scale||Full Range|Mean
634335|NCT02763189|Primary|Apnea Time|Apnea time was measured in seconds from the time the ventilator was disconnected from the original endotracheal tube to the time the ventilator was connected to the new endotracheal tube immediately after procedure.|immediately after the procedure|||seconds||Full Range|Mean
634336|NCT02761733|Primary|Communication Satisfaction Questionnaire|Communication satisfaction was measured utilizing a modified version of a 19-item measure of communication patterns between physicians and their clients (Campbell et al., 2007). Thirteen items focusing on the client’s satisfaction with communication with their provider and their engagement in treatment were measured on a 7-point scale (strongly agree, agree, agree somewhat, undecided, disagree somewhat, disagree, strongly disagree). Example items included “My provider checks to be sure that I understand everything” or “My provider involves me in decisions as much as I want.” Total average scores range from 1 to 7 with higher scores indicating better communication satisfaction. Analyses will examine change in Satisfaction Questionnaire scores from pre- to post-intervention.|Change in scores on the Communication Satisfaction Questionnaire from Baseline to 24 month follow-up|Several factors influenced variability in the number of participants analyzed across time points. First, patients may have responded to some items but opted out of others because of questionnaire length or comprehension considerations. Second, some patients were available at baseline but were unavailable at subsequent time points, or vice versa.||units on a scale||Standard Deviation|Mean
634337|NCT02761733|Primary|Working Alliance Inventory|The Working Alliance Inventory measures the perception of therapeutic alliance in a clinical dyad during the process of developing a relationship required for effective psychotherapy. The current study utilized the client version of the Working Alliance Inventory included 7 items measured on a 7-point scale (never, rarely, occasionally, sometimes, often, very often, always). Example items included “I am confident in my provider’s ability to help me” and “My provider and I trust one another.” The Working Alliance Inventory total average score ranges from 1 to 7, with high scores indicating a more positive outcome. Analyses will examine change in patient-reported Working Alliance Inventory scores from pre- to post-intervention.|Change in scores on the Working Alliance Inventory from Baseline to 24 month follow-up|Several factors influenced variability in the number of participants analyzed across time points. First, patients may have responded to some items but opted out of others because of questionnaire length or comprehension considerations. Second, some patients were available at baseline but were unavailable at subsequent time points, or vice versa.||units on a scale||Standard Deviation|Mean
634338|NCT02761733|Primary|Shared Decision Making Questionnaire|A 6-item modified version of the Shared Decision Making Questionnaire (SDM-Q-9) 46 was utilized to assess client reports about the degree to which their provider involved them in understanding and making a treatment decision. Examples items included “My provider discussed the advantages and disadvantages of options and strategies” or “My provider helped me understand all the information” measured on a 6-point scale (completely disagree, strongly disagree, somewhat disagree, somewhat agree, strongly agree, and completely agree). The total average score ranges from 1 to 6 with higher scores indicating a better outcome of greater shared decision making. Analyses will examine change in Shared Decision Making Questionnaire scores from pre- to post-intervention.|Change in scores on the Shared Decision Making Questionnaire from Baseline to 24 month follow-up|Several factors influenced variability in the number of participants analyzed across time points. First, patients may have responded to some items but opted out of others because of questionnaire length or comprehension considerations. Second, some patients were available at baseline but were unavailable at subsequent time points, or vice versa.||units on a scale||Standard Deviation|Mean
634379|NCT02756637|Primary|Overall Survival|Number of participants who survived at 26 years are reported.|26 years|||participants|||Number
678517|NCT01596842|Secondary|Change of Intact Parathyroid Hormone||12 weeks||||||
634339|NCT02761733|Primary|Outcome Rating Scale (ORS)|The Outcome Rating Scale (ORS) was utilized as a repeated measure of general therapy outcomes and quality of life changes during the course of therapy. The Outcome Rating Scale includes a visual analog scale (a horizontal line on which the participants marks how well they are doing within the last week from low to high) that records four questions about general well-being, personal well-being, close relationships, and work/school/friend relationships. Physical marks for each of four domains on the visual analog scale are measured by research team members with a ruler and converted to a score from 1 to 100. The four items are then averaged for an overall therapy outcome score. The total averaged ORS score ranges from 1 to 100, with higher scores indicating a better outcome. Analyses will examine treatment progress via change in ORS scores from pre- to post-intervention.|Change in scores on the Outcome Rating Scale from Baseline to 24 month follow-up|Several factors influenced variability in the number of participants analyzed across time points. First, patients may have responded to some items but opted out of others because of questionnaire length or comprehension considerations. Second, some patients were available at baseline but were unavailable at subsequent time points, or vice versa.||units on a scale||Standard Deviation|Mean
634340|NCT02761733|Primary|Short Form Health Survey-12 (SF-12) Mental Symptoms|The mental health subscale (MCS-12; Mental Component Summary) of the SF-12 (Health Survey Short Form-12) was utilized in the current study to assess mental aspects of health and well-being48. The measure includes twelve questions asking about overall health, limitations from health conditions, physical health, emotional well-being and daily activities, and feelings over the past four weeks, utilizing variable Likert scale response choice options. The physical health subscale of the SF-12 was utilized as a key client functioning outcome in the current study. The aggregate MCS subscale score of the SF-12 is calculated utilizing norm-based scoring with a weighted sum (Ware, Kosinski, & Keller, 1995). MCS scores in the present study ranged from 9.6 to 72.0, with higher values indicating better physical health.|Change in scores on the SF-12 from Baseline to 24 month follow-up Description: The Health Survey Short Form-12 (SF-12) includes 12 items that assess for physical and mental aspects of health and well-being.|Several factors influenced variability in the number of participants analyzed across time points. First, patients may have responded to some items but opted out of others because of questionnaire length or comprehension considerations. Second, some patients were available at baseline but were unavailable at subsequent time points, or vice versa.||units on a scale||Standard Deviation|Mean
634341|NCT02761733|Primary|Short Form Health Survey-12 (SF-12), Physical Symptoms Subscale|The physical health subscale (PCS-12; Physical Component Summary) of the SF-12 (Health Survey Short Form-12) was utilized in the current study to assess physical aspects of health and well-being48. The measure includes twelve questions asking about overall health, limitations from health conditions, physical health, emotional well-being and daily activities, and feelings over the past four weeks, utilizing variable Likert scale response choice options. The aggregate PCS subscale score of the SF-12 is calculated utilizing norm-based scoring with a weighted sum (Ware, Kosinski, & Keller, 1995). PCS scores in the present study ranged from 13.2 to 65.6, with higher values indicating better physical health.|Change in scores on the SF-12 from Baseline to 24 month follow-up|Several factors influenced variability in the number of participants analyzed across time points. First, patients may have responded to some items but opted out of others because of questionnaire length or comprehension considerations. Second, some patients were available at baseline but were unavailable at subsequent time points, or vice versa.||units on a scale||Standard Deviation|Mean
634342|NCT02761629|Secondary|Percentage of Participants With Alanine Aminotransferase (ALT) Level Categories|ALT levels were classified as: Normal Limit (NL) (as per laboratory standard), >1-2 Upper Normal Limit (ULN), >2-5 ULN, >5-10 ULN, and >10 ULN. Percentage of participants in each of these ALT level categories was reported. Data for this outcome measure was to be reported up to 24 weeks after end of treatment visit (Week 72 for 'Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks' arm and Week 96 for 'Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks' arm).|For “Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks” arm: Weeks 4, 12, 24, 48, and 72; for “Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks” arm: Weeks 4, 12, 24, 48, 72, and 96|Safety analysis population: all randomized participants who receive >/=1 dose of any study medication and had >/=1 post-baseline safety assessment. Number of participants analyzed= overall participants who were evaluable for this outcome at any time-point and “n” = participants who were evaluable at specified time-point; for each arm, respectively.||percentage of participants|||Number
634343|NCT02761629|Secondary|Change From Baseline in CD4/CD8 Ratio at Weeks 4, 12, 24, 48, 72, and 96|Data for this outcome measure was to be reported up to 24 weeks after end of treatment visit (Week 72 for 'Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks' arm and Week 96 for 'Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks' arm).|For “Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks” arm: Baseline, Weeks 4, 12, 24, 48, and 72; for “Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks” arm: Baseline, Weeks 4, 12, 24, 48, 72, and 96|"ITT analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome and n = participants who were evaluable at specified time-point; for each arm, respectively."||Ratio||Standard Deviation|Mean
634344|NCT02761629|Secondary|Change From Baseline in Cluster of Differentiation (CD) 4 (CD4) Cell Counts at Weeks 4, 12, 24, 48, 72, and 96|Data for this outcome measure was to be reported up to 24 weeks after end of treatment visit (Week 72 for 'Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks' arm and Week 96 for 'Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks' arm).|For “Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks” arm: Baseline, Weeks 4, 12, 24, 48, and 72; for “Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks” arm: Baseline, Weeks 4, 12, 24, 48, 72, and 96|"ITT analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome and n = participants who were evaluable at specified time-point; for each arm, respectively."||Cells per cubic millimeter (cells/mm^3)||Standard Deviation|Mean
634345|NCT02761629|Secondary|Serum Human Immunodeficiency Virus (HIV) RNA Levels|HIV RNA levels were measured using Roche AMPLICOR MONITOR HIV-1 Test (limit of detection: 400 HIV-1 RNA copies/mL). Data for this outcome measure was to be reported up to 24 weeks after end of treatment visit (Week 72 for 'Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks' arm and Week 96 for 'Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks' arm).|For “Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks” arm: Weeks 4, 12, 24, 48, and 72; for “Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks” arm: Weeks 4, 12, 24, 48, 72, and 96|"ITT analysis population. Here, number of participants analyzed = participants with detectable HIV RNA levels and n = participants with detectable HIV RNA levels at specified time-point; for each arm, respectively."||Log10 copies per milliliter||Standard Deviation|Mean
639962|NCT02368314|Secondary|Frequency of Venous Thromboembolism (PATE and/or DTV)||During the treatment period (14 days) and follow-up period (till 60-th day)||||||
634346|NCT02761629|Secondary|Percentage of Participants Without SVR Among Participants With Undetectable HCV RNA at the End of Treatment|SVR was defined as having undetectable HCV RNA levels 24 weeks after completion of study treatment. HCV RNA levels were measured using Roche COBAS AMPLICOR HCV Test (limit of detection: 50 IU/mL). Percentage of participants without SVR among participants with undetectable HCV RNA at the end of treatment was reported (end of treatment = Week 48 for “Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks” arm and Week 72 for “Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks” arm).|24 weeks after completion of study treatment (up to Week 72 for “Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks” arm and up to Week 96 for “Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks” arm)|ITT analysis population. Here, number of participants analyzed signifies participants with undetectable HCV RNA at the end of treatment.||percentage of participants|||Number
634347|NCT02761629|Secondary|Percentage of Participants With Undetectable HCV RNA 12 Weeks After the Last Dose of Peg-IFN-Alpha-2A|HCV RNA levels were measured using Roche COBAS AMPLICOR HCV Test (limit of detection: 50 IU/mL). Participants with detectable HCV RNA or without measurement at the end of 12 weeks after the last dose of Peg-IFN-Alpha-2A were considered as non-responders.|12 weeks after the last dose of Peg-IFN-Alpha-2A (up to Week 60 for “Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks” arm and up to Week 84 for “Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks” arm)|ITT analysis population||percentage of participants||95% Confidence Interval|Number
634348|NCT02761629|Secondary|Percentage of Participants With Undetectable HCV RNA|HCV RNA levels were measured using Roche COBAS AMPLICOR HCV Test (limit of detection: 50 IU/mL). Data for this outcome measure was to be reported up to end of treatment visit (Week 48 for ‘Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks’ arm and Week 72 for ‘Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks’ arm).|For “Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks” arm: Weeks 4, 12, 24, and 48; for “Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks” arm: Weeks 4, 12, 24, 48, and 72|"ITT analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome and n = participants who were evaluable for this outcome at specified time-point; for each arm, respectively."||percentage of participants||95% Confidence Interval|Number
634349|NCT02761629|Primary|Percentage of Participants With Sustained Virologic Response (SVR)|SVR was defined as having un-detectable hepatitis C virus (HCV) ribonucleic acid (RNA) levels 24 weeks after completion of study treatment. HCV RNA levels were measured using Roche COBAS AMPLICOR HCV Test (limit of detection: 50 International Units per milliliter [IU/mL]). Participants with detectable HCV RNA or without measurement at the end of the 24 week after completion of study treatment were considered as non-responders.|24 weeks after completion of study treatment (up to Week 72 for “Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks” arm and up to Week 96 for “Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks” arm)|Intent-to-treat (ITT) analysis population||percentage of participants||95% Confidence Interval|Number
634350|NCT02760810|Secondary|Tear Film PH|Tear Film PH was measured using a 1mm Microglass electrode (Thermo Scientific Orion 9810BN) placed gently in lower temporal tear meniscus of non-Schirmer eye without simulating reflex tearing.|1-Week Follow-up|Subjects that completed all study visits without a major protocol deviation.||PH value||Standard Deviation|Mean
634351|NCT02760810|Secondary|Tear Film Osmolarity|Tear film osmolarity was measured in each subject eye using the TearLab Osmolarity system. The instrument was placed gently into the lower lid temporal tear minuscus without simulating reflex tearing.|1-Week Follow-up|Subjects that completed all study visits without a major protocol deviation.||mOsm/L|Eyes|Standard Deviation|Mean
634352|NCT02760810|Primary|Tear Film Osmolarity|Tear film osmolarity was measured in each subject eye using the TearLab Osmolarity system. The instrument was placed gently into the lower lid temporal tear minuscus without simulating reflex tearing|2-Week Follow-up|Subjects that completed all study visits without a major protocol deviation.||mOsm/L|Eyes|Standard Deviation|Mean
634353|NCT02760654|Secondary|Change in PROMIS Pain Interference 4a Scores at 8 Weeks|The PROMIS Pain Interference 4a is scored on a scale of 41.6 to 75.6, with a score of 41.6 meaning little or no interference with daily activities due to pain severity, and a score of 75.6 meaning a high degree of interference with daily activities due to pain severity.|Baseline to 8 weeks|Only 19 in the people in the online self-management group and 23 in the Control group of the 23 and 24 that completed the study actually completed the information for this measure. Thus only 19 and 23 respectively are analyzed.||units on a scale||Standard Deviation|Mean
634354|NCT02760654|Secondary|Change in European Organization of Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy Scale Scores at 8 Weeks|The European Organization of Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy contains three subscales: Sensory, Motor, and Autonomic. Each subscale is scored on a scale of 0 - 100, with a score of 0 representing no neuropathy symptoms and functional impairment due to neuropathy, and a score of 100 represents severe neuropathy symptoms and functional impairment due to neuropathy. Only the Sensory and Motor subscales were used in this current study.|Baseline to 8 weeks|Only 19 in the people in the online self-management group and 23 in the Control group of the 23 and 24 that completed the study actually completed the information for this measure. Thus only 19 and 23 respectively are analyzed.||units on a scale||Standard Deviation|Mean
634355|NCT02760654|Secondary|Adapted Acceptability E-Scale|The Adapted Acceptability E- Scale contains 7 items that are scored on a 1 - 5 scale, with a score of 1 representing low ratings of acceptability and satisfaction with the online self management program, and a score of 5 representing high ratings of acceptability and satisfaction with the online self management program. This measure was only administered to individuals participating in the online self management program.|8 week|Only 19 in the people in the online self-management group of the 23 that completed the study actually completed the information for this measure. Thus only 19 are analyzed. No participants in the control group were administered this measure because the questions pertained to the acceptability and satisfaction of the online self management program.||units on a scale||Standard Deviation|Mean
634356|NCT02760654|Secondary|Change in 0 - 10 Average Pain Intensity Numerical Rating Scale Scores at 8 Weeks|The 0 - 10 Average Pain Intensity Numerical Rating Scale was scored on a scale of 0 - 10, with a score of 0 meaning no pain, and a score of 10 meaning worst pain imaginable.|Baseline to 8 weeks|Only 19 in the people in the online self-management group and 23 in the Control group of the 23 and 24 that completed the study actually completed the information for this measure. Thus only 19 and 23 respectively are analyzed.||units on a scale||Standard Deviation|Mean
634380|NCT02756624|Primary|Number of Treatment Related Adverse Events|Adverse events will be measured through study completion|up to 12 weeks|Intent to Treat (ITT)||adverse events|||Number
634357|NCT02760654|Secondary|Patient Global Impression of Change|The Patient Global Impression of Change is scored on a scale of 1 - 7, with a score of 1 representing that the patient was very much worse following the trial, and a score of 7 representing that the patient was very much improved following the course of the trial.|8 week|Only 19 in the people in the online self-management group and 22 in the Control group of the 23 and 24 that completed the study actually completed the information for this measure. Thus only 19 and 22 respectively are analyzed.||Participants|||Count of Participants
634358|NCT02760654|Secondary|Change in PROMIS Short Form Sleep-Related Impairment 8a Scores at 8 Weeks|The PROMIS Short Form Sleep-Related Impairment 8a is scored on a scale of 30.0 to 80.1 with a score of 30.0 meaning no sleep-related impairment and a score of 80.1 meaning a high degree of impairment in daily activities due to poor sleep.|Baseline to 8 weeks|Only 19 in the people in the online self-management group and 23 in the Control group of the 23 and 24 that completed the study actually completed the information for this measure. Thus only 19 and 23 respectively are analyzed.||units on a scale||Standard Deviation|Mean
634359|NCT02760654|Secondary|Change in PROMIS Short Form Fatigue 4a Scores at 8 Weeks|The PROMIS Short Form Fatigue 4a is scored on a scale of 33.7 to 75.8, with a score of 33.7 meaning no fatigue and a score of 75.8 meaning high fatigue.|Baseline to 8 weeks|Only 19 in the people in the online self-management group and 23 in the Control group of the 23 and 24 that completed the study actually completed the information for this measure. Thus only 19 and 23 respectively are analyzed.||units on a scale||Standard Deviation|Mean
634360|NCT02760654|Secondary|PROMIS Short Form Anxiety 4a|The PROMIS Short Form Anxiety 4a is scored on a scale of 40.3 - 81.6, with a score of 40.3 meaning no anxiety and a score of 81.6 meaning high anxiety.|Baseline to 8 weeks|Only 19 in the people in the online self-management group and 23 in the Control group of the 23 and 24 that completed the study actually completed the information for this measure. Thus only 19 and 23 respectively are analyzed.||units on a scale||Standard Deviation|Mean
634361|NCT02760654|Secondary|Change in PROMIS Short Form Emotional Distress - Depression 4a Scores at 8 Weeks|The PROMIS short form emotional distress depression 4a Scores are measured on a scale whose lowest possible score is 41.0 and highest is 79.4 where 41 is no emotional distress and 79.4 is extreme distress.|Baseline to 8 weeks|Only 19 in the people in the online self-management group and 23 in the Control group of the 23 and 24 that completed the study actually completed the information for this measure. Thus only 19 and 23 respectively are analyzed.||units on a scale||Standard Deviation|Mean
634362|NCT02760654|Primary|Change in 0 - 10 Numerical Rating Scale of Worst Pain Intensity Scores at 8 Weeks|Pain is measured on the numerical rating scale of 0 - 10 where 0 is no pain and 10 is worst imaginable pain.|Baseline to 8 weeks|Only 19 people in each arm out of the 23 and 24 that completed the study actually completed the information for this measure. Thus only 19 are analyzed.||units on a scale||Standard Deviation|Mean
634363|NCT02759692|Secondary|Individual Patient Reported Outcomes (Items 15-17)|"Individual patient reported outcomes questions were used to assess patient-experience attributes of soft contact lenses (e.g. comfort and vision). Items were assessed at the 7-Day follow-up using a 5-point scale of either (1) Strongly Disagree, Disagree, Neither Agree nor Disagree, Agree, Strongly Agree or (2) Poor, Fair, Good, Very Well, Excellent. Subject's responses for each item were dichotomoized into top-two-box (T2B) response where T2B=1 if a subject responded positively to the question which is dependent on the response set) and T2B=0 otherwise. The percentage of T2B for each item and lens was reported. The following items were asked: ([] indicate the question was abbreviated due to space). 15.Clarity of vision during daily activities 16.Clarity of vision in dim or low lighting conditions 17. Clarity of visions when driving at night."|7-Day Follow-up|Subjects that completed all study visits without a major protocol deviation.||Percentage of Responses|Observations||Number
634364|NCT02759692|Secondary|Individual Patient Reported Outcomes (Items 11-14)|"Individual patient reported outcomes questions were used to assess patient-experience attributes of soft contact lenses (e.g. comfort and vision). Items were assessed at the 7-Day follow-up using a 5-point scale of either (1) Strongly Disagree, Disagree, Neither Agree nor Disagree, Agree, Strongly Agree or (2) Poor, Fair, Good, Very Well, Excellent. Subject's responses for each item were dichotomoized into top-two-box (T2B) response where T2B=1 if a subject responded positively to the question which is dependent on the response set) and T2B=0 otherwise. The percentage of T2B for each item and lens was reported. The following items were asked: ([] indicate the question was abbreviated due to space). 11.I was very satisfied with my distance vision when i first put these lenses in my eyes. 12.I was very satisfied by the clarity of my vision at the end of the day 13.I was satisfied with the quality of my vision at night 14.With these lenses, I felt very confident to drive at night"|7-Day Follow-up|Subjects that completed all study visits without a major protocol deviation.||Percentage of Responses|Observations||Number
634365|NCT02759692|Secondary|Individual Patient Reported Outcomes (Items 6-10)|"Individual patient reported outcomes questions were used to assess patient-experience attributes of soft contact lenses (e.g. comfort and vision). Items were assessed at the 7-Day follow-up using a 5-point scale of either (1) Strongly Disagree, Disagree, Neither Agree nor Disagree, Agree, Strongly Agree or (2) Poor, Fair, Good, Very Well, Excellent. Subject's responses for each item were dichotomoized into top-two-box (T2B) response where T2B=1 if a subject responded positively to the question which is dependent on the response set) and T2B=0 otherwise. The percentage of T2B for each item and lens was reported. The following items were asked: ([] indicate the question was abbreviated due to space)6. Comfort at the end of the day 7. They remained comfortable from the moment I put them in until the moment I took them out 8.Comfort from activity to activity 9. Comfort across different environments 10.Comfort while working on a computer"|7-Day Follow-up|Subjects that completed all study visits without a major protocol deviation.||Percentage of Responses|Observations||Number
634381|NCT02756624|Primary|Tolerability of AC 170 0.24% at Visit 3 (Day 22)|Tolerability was assessed upon instillation of study medication, at 1 minute and 2 minutes post study medication instillation. Drop comfort was assessed using a 0-to 10 scale where 0=very comfortable and 10=very uncomfortable.|Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation|Intent to Treat (ITT)||units on a scale||Standard Deviation|Mean
634382|NCT02756624|Primary|Tolerability of AC 170 0.24% at Visit 2 (Day 8)|Tolerability was assessed upon instillation of study medication, at 1 minute and 2 minutes post study medication instillation. Drop comfort was assessed using a 0-to 10 scale where 0=very comfortable and 10=very uncomfortable.|Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation|Intent to Treat (ITT)||units on a scale||Standard Deviation|Mean
634366|NCT02759692|Secondary|Individual Patient Reported Outcomes (Items 1-5)|"Individual patient reported outcomes questions were used to assess patient-experience attributes of soft contact lenses (e.g. comfort and vision). Items were assessed at the 7-Day follow-up using a 5-point scale of either (1) Strongly Disagree, Disagree, Neither Agree nor Disagree, Agree, Strongly Agree or (2) Poor, Fair, Good, Very Well, Excellent. Subject's responses for each item were dichotomoized into top-two-box (T2B) response where T2B=1 if a subject responded positively to the question which is dependent on the response set) and T2B=0 otherwise. The percentage of T2B for each item and lens was reported. The following items were asked: ([] indicate the question was abbreviated due to space)1.These Lenses Were Very Comfortable At The End Of The Day 2.The Comfort of these lenses decreased throughout the day 3. The lenses were very comfortable from the time I got up to the time I went to bed 4. Overall Comfort 5. Comfort throughout the Day"|7-Day Follow-up|Subjects that completed all study visits without a major protocol deviation.||Percentage of Responses|Observations||Number
634367|NCT02759692|Primary|Overall Quality of Vision|Overall quality of vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. Please note this was a 2 treatment by 3 period study design. Therefore, some subjects were randomized to receive one of the study lenses twice, hence the number of observations were summarized per lens type. For the senofilcon A lens 132+136+132=400 (Observations- 1 per subject per period) from period 1, 2 and 3 respectively. For the stenfilcon A lens 136+132+136=404 (observations) from period 1, 2 and 3 respectively.|7-Day Follow-up|Subjects that completed all study visits without a major protocol deviation.||Units on a Scale|Observations|Standard Deviation|Mean
634368|NCT02759692|Primary|Overall Comfort|Overall comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. Please note this was a 2 treatment by 3 period study design. Therefore, some subjects were randomized to receive one of the study lenses twice, hence the number of observations were summarized per lens type. For the senofilcon A lens 132+136+132=400 (Observations- 1 per subject per period) from period 1, 2 and 3 respectively. For the stenfilcon A lens 136+132+136=404 (observations) from period 1, 2 and 3 respectively.|7-Day Follow-up|Subjects that completed all study visits without a major protocol deviation.||Units on a Scale|Observations|Standard Deviation|Mean
634369|NCT02759471|Primary|Lens Preference/Acceptability|Investigators preference/acceptability for comfilcon A sphere and comfilcon A asphere lenses. (Choices: strongly prefer study lenses, slightly prefer study lenses, slightly prefer habitual lenses, strongly prefer habitual lenses).|baseline, 2 weeks, 1 month|||participants|||Number
634370|NCT02759471|Primary|Lens Fit - Post-blink Movement|Lens fit evaluation of post-blink movement for comfilcon A sphere and comfilcon A asphere lens. (Scale 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).|baseline, 2 weeks, 1 month|One participants data for both the 2 week and 1 month visit was not included due to participant protocol deviation.||units on a scale||Standard Deviation|Mean
634371|NCT02759471|Primary|Lens Fit - Corneal Coverage|Lens fit evaluation of corneal coverage for comfilcon A sphere and comfilcon A asphere lens. ('yes' - full coverage, or 'no' - incomplete corneal coverage).|baseline, 2 weeks, 1 month|One participants data for both the 2 week and 1 month visit was not included due to participant protocol deviation.||participants|||Number
634372|NCT02759471|Primary|Lens Fit - Centration|Lens fit evaluation of centration for comfilcon A sphere and comfilcon A asphere lens. (Scale: optimum, decentration acceptable and decentration unacceptable).|baseline, 2 weeks, 1 month|One participants data for both the 2 week and 1 month visit was not included due to participant protocol deviation.||participants|||Number
634373|NCT02758210|Secondary|Number of Participants Reporting Clinical Symptoms While Using a Tablet|Participants were asked to report any clinical symptoms that they experienced when using the tablet.|During use of Tablet|||Participants|||Count of Participants
634374|NCT02758210|Secondary|Number of Participants Reporting Clinical Symptoms While Using a Smart Phone|Participants were asked to report any clinical symptoms that they experienced when using the smart phone.|During use of Smart Phone|||Participants|||Count of Participants
634375|NCT02758210|Primary|Device Response While Using a Tablet, Assessed by Ventricular Pacing|Ventricular pacing before and during use of a tablet was monitored to assess if there's inhibition of ventricular pacing due to electromagnetic field exposure. The initial programmed pacing settings of the MICRA device are compared to any changes during the tablet usage. The assessment of this outcome measure takes an average of 5 minutes.|Before use of Tablet, During use of Tablet|||millivolts (mV)||Standard Deviation|Mean
634376|NCT02758210|Primary|Number of Participants Experiencing Inhibition of Ventricular Pacing While Using a Smart Phone|Ventricular pacing before and during use of a smart phone was monitored to assess the presence of inhibition of ventricular pacing due to electromagnetic field exposure. The programmed pacing of the MICRA device is specific for each participant. The individualized, initial programmed pacing settings of the MICRA device are compared to any changes during the smart phone usage.|During use of Smart Phone|||Participants|||Count of Participants
634377|NCT02758210|Primary|Number of Participants Experiencing Asynchronous Pacing While Using a Tablet|Cardiac pacing before and during use of a tablet were monitored to assess if there is asynchronous pacing due to electromagnetic field exposure. The initial programmed pacing settings of the MICRA device are compared to any changes during the tablet usage.|Before use of Tablet, During use of Tablet|||Participants|||Count of Participants
634378|NCT02758210|Primary|Device Response Assessed by Asynchronous Pacing When Using a Smart Phone|Cardiac pacing before and during use of a smart phone was monitored to assess asynchronous pacing due to electromagnetic field exposure. The initial programmed pacing settings of the MICRA device are compared to any changes during the smart phone usage. This assessment lasts for a duration of 5 minutes, on average.|Before use of Smart Phone, During use of Smart Phone|||ohms||Standard Deviation|Mean
634383|NCT02756624|Primary|Tolerability of AC 170 0.24% at Visit 1 (Day 1)|Tolerability was assessed upon instillation of study medication, at 1 minute and 2 minutes post study medication instillation. Drop comfort was assessed using a 0-to 10 scale where 0=very comfortable and 10=very uncomfortable.|Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation|Intent to Treat (ITT)||units on a scale||Standard Deviation|Mean
634384|NCT02756351|Secondary|Any Adverse Events Such as Skin Reactions, Allergic Reactions, Abrasions, Shears or Wounds Due to Contact or Pressure of the Device on the Nose of Subjects Occurring During the Study.||18 hours|||Adverse Events|||Number
634385|NCT02756351|Primary|Mean Difference in Bacterial Colonization of the Nasal Prong After 18 Hours of Device Usage When Comparing the CytaCoat Nasal Prong to the Reference Device.||18 hours|||fold change in log value||Standard Deviation|Mean
634386|NCT02755805|Secondary|Differences in Apathy Symptoms Between Groups Over Time|"Difference in mean Apathy Evaluation Scale total scores were examined between groups over time using repeated measures fixed effects models.
The Apathy Evaluation Scale measures lack of motivation or interest in goal-directed activities. The scale has 18 items yielding a total score of 18 (indicating absence of apathy) to 72 (indicating severe apathy). Total scores were generated for each participant at each time, and mean scores were computed for each group at each time point."|Baseline, 3 months, 6 months|||units on a scale||Standard Error|Mean
634387|NCT02755805|Secondary|Difference in Executive Function - Cognitive Flexibility, CWI (Color Word Interference Switching Scale)|"Difference between groups in mean scaled scores (Color Word Interference Switching Scale) over time using mixed effects models.
The Cognitive Flexibility Scale raw scores were converted to norm-referenced scaled scores adjusted for age and education. These scores are aligned with a population mean of 10, and standard deviation of 3. Higher scores indicate better executive function. Scaled scores were generated at baseline, month 3, and month 6 for each participant, and mean scaled scores were computed for each group at each time point."|Baseline, 3 months, 6 months|||units on a scale||Standard Error|Mean
634388|NCT02755805|Secondary|Difference in Executive Function- Inhibition, CWI (Color Word Interference Inhibition Scale)|"Difference mean scaled scores (Color Word Interference Inhibition Scale) between groups over time using mixed effects models.
The Color Word Interference Inhibition Scale raw scores are converted to norm-referenced scaled scores adjusted for age and education. These scores are aligned with a population mean of 10, and standard deviation of 3. Higher scores indicate better executive function. Scaled scores were generated at baseline, month 3, and month 6 for each participant, and mean scaled scores were computed for each group at each time point."|Baseline, 3 months, 6 months|||units on a scale||Standard Error|Mean
634389|NCT02755805|Primary|Difference in Independence With Activities of Daily Living (Functional Independence Measure) Between Groups Over Time|"Difference between groups in mean scores (computed from Functional Independence Measure total scores) over time were examined with mixed effects models.
The Functional Independence Measure contains 18 items with a total score ranging from 18-126 is obtained (18=complete dependence/total assistance with basic self-care and mobility activities; 126=complete independence with basic self-care and mobility activities). Total scores were calculated at baseline, rehabilitation discharge, month 3, and month 6 for each participant, and mean total scores were calculated fro each group at each time point."|Baseline, rehabilitation discharge, month 3, month 6|||units on a scale||Standard Error|Mean
634390|NCT02755090|Primary|Satisfaction With Anesthesia (Iowa Satisfaction With Anesthesia Scale [ISAS])|The Iowa Satisfaction with Anesthesia Scale (ISAS) was given to women following a surgical abortion. The ISAS score is the mean of 11 responses to questions regarding satisfaction with anesthesia and has a score range of -3 (disagree strongly) to 3 (agree strongly).|Assessed 30 minutes after procedure completion.|||units on a scale||Standard Deviation|Mean
634391|NCT02755090|Primary|Visual Analog Scale (VAS) Score for Maximum Procedural Pain|To compare women’s maximum procedural pain measured on a visual analog scale (VAS) during a surgical abortion between 12 weeks 0 days to 16 weeks 0 days gestational age between women randomized to nitrous oxide versus intravenous sedation. A score of 0 represents no pain and a score of 100 represents pain as bad as it could be.|Assessed immediately following completion of the procedure (as defined as removal of the speculum)|||units on a scale||Full Range|Mean
634392|NCT02753699|Secondary|Percentage of Participants With Normal Alanine-aminotransferase (ALT) Values at Week 48.|Note that the 24-week period between end of feeder study (SVR24) and first visit in this follow-up study is not counted in the 48 weeks, so this timepoint corresponds to 96 weeks (=24+24+48) after the last dose of alisporivir.|at Week 48|Full analysis set. In the categories, n is the number of subjects in FAS in the appropriate study group with normal ALT at visit; for Overall - at all available visits.||percentage of participants|||Number
634393|NCT02753699|Primary|Percentage of Participants Maintaining Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Load Below the Level of Quantification (LOQ) Through Week 48||up to 120 Weeks|Full analysis set (FAS), defined as all participants who enrolled into this study and had at least one HCV RNA assessment, unless excluded due to protocol deviations.||percentage of participants|||Number
634394|NCT02753413|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From vaccination (Day 0) up to study end (Day 30)|The analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with study vaccine administration documented.||Participants|||Count of Participants
634395|NCT02753413|Primary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset out-side the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During a 30-day follow-up period (from Day 0 to Day 29) after vaccination|The analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with study vaccine administration documented.||Participants|||Count of Participants
634452|NCT02750267|Secondary|Hyperglycemia Area Under the Curve >250 mg/dL|All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.|72 hours||||||
634453|NCT02750267|Secondary|Hyperglycemia Area Under the Curve >180|All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.|72 hours||||||
634396|NCT02753413|Primary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms were fatigue, temperature (defined as oral temperature equal to or above [≥] 37.5 degrees Celsius [°C] for oral, axillary or tympanic route), gastrointestinal symptoms (gastro) including nausea, vomiting, diarrhoea and/or abdominal pain; and headache. Any = occurrence of the symptom regardless of intensity grade and relationship to the vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.|During a 7-day follow-up period (from Day 0 to Day 6) after vaccination|The analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with study vaccine administration documented.||Participants|||Count of Participants
634397|NCT02753413|Primary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimetres (mm) of injection site. All solicited local symptoms are considered as related to the vaccination.|During a 7-day follow-up period (from Day 0 to Day 6) after vaccination|The analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with study vaccine administration documented.||Participants|||Count of Participants
634398|NCT02753413|Primary|Number of Subjects With Haematology Change From Baseline by Maximum Grade|Assessed laboratory parameter changed from baseline was haemoglobin (Hgb). FDA grading for Hgb (change from baseline) was not applicable a baseline.|From Day 7 up to Day 30|The analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with study vaccine administration documented.||Participants|||Count of Participants
634399|NCT02753413|Primary|Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading|Among haematological parameters tested were NEU, PLT, decreased WBC and increased WBC/I, graded by FDA toxicity grading for haematology parameters. Assessed grades were unknown, grade 0 [G0], grade 1 [G1] (mild), grade 2 [G2] (moderate), grade 3 [G3] (severe) and grade 4 [G4] (potentially life threatening), as compared to baseline at Day 0.|From Day 7 up to Day 30|The analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with study vaccine administration documented.||Participants|||Count of Participants
634400|NCT02753413|Primary|Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading|Among haematological parameters tested were EOS, decreased Hgb and LYM graded by FDA toxicity grading for haematology parameters. Assessed grades were unknown, grade 0 [G0], grade 1 [G1] (mild), grade 2 [G2] (moderate), grade 3 [G3] (severe) and grade 4 [G4] (potentially life threatening), as compared to baseline at Day 0.|From Day 7 up to Day 30|The analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with study vaccine administration documented||Participants|||Count of Participants
634401|NCT02753413|Primary|Number of Subjects With Abnormal Biochemical Laboratory Parameter Values by Maximum Grading|Among biochemical parameters tested were ALT, AST and CRE, graded by FDA toxicity grading for biochemistry parameters. Assessed grades were unknown, grade 0 [G0], grade 1 [G1] (mild), grade 2 [G2] (moderate), grade 3 [G3] (severe) and grade 4 [G4] (potentially life threatening), as compared to baseline at Day 0.|From Day 7 up to Day 30|The analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with study vaccine administration documented.||Participants|||Count of Participants
634402|NCT02753413|Primary|Number of Subjects With Abnormal Haematological Laboratory Values.|Among analysed haematological parameters were eosinophils [EOS], haemoglobin [Hgb], leukocytes (white blood cells) [WBC], lymphocytes [LYM], neutrophils [NEU] and platelets [PLT]. Haematological value ranges assessed were below, within or above, as compared to baseline at Day 0. This outcome presents values for LYM, NEU and PLT.|At Day 30|The analysis was performed on the Total Vaccinated Cohort (TVC) which included all subjects with study vaccine administration documented.||Participants|||Count of Participants
634403|NCT02753413|Primary|Number of Subjects With Abnormal Haematological Laboratory Values.|Among analysed haematological parameters were eosinophils [EOS], haemoglobin [Hgb], leukocytes (white blood cells) [WBC], lymphocytes [LYM], neutrophils [NEU] and platelets [PLT]. Haematological value ranges assessed were below, within or above, as compared to baseline at Day 0. This outcome presents values for LYM, NEU and PLT|At Day 7|The analysis was performed on the Total Vaccinated Cohort (TVC) which included all subjects with study vaccine administration documented.||Participants|||Count of Participants
634404|NCT02753413|Primary|Number of Subjects With Abnormal Haematological Laboratory Values.|Among analysed haematological parameters were eosinophils [EOS], haemoglobin [Hgb], leukocytes (white blood cells) [WBC], lymphocytes [LYM], neutrophils [NEU] and platelets [PLT]. Haematological value ranges assessed were below, within or above, as compared to baseline at Day 0. This outcome presents values for EOS, Hgb and WBC.|At Day 30|The analysis was performed on the Total Vaccinated Cohort (TVC) which included all subjects with study vaccine administration documented.||Participants|||Count of Participants
634405|NCT02753413|Primary|Number of Subjects With Abnormal Haematological Laboratory Values.|Among analysed haematological parameters were eosinophils [EOS], haemoglobin [Hgb], leukocytes (white blood cells) [WBC], lymphocytes [LYM], neutrophils [NEU] and platelets [PLT]. Haematological value ranges assessed were below, within or above, as compared to baseline at Day 0. This outcome presents values for EOS, Hgb and WBC.|At Day 7|The analysis was performed on the Total Vaccinated Cohort (TVC) which included all subjects with study vaccine administration documented.||Participants|||Count of Participants
634406|NCT02753413|Primary|Number of Subjects With Abnormal Biochemical Laboratory Values.|Among analysed biochemical parameters were alanine aminotransferase [ALT], aspartate aminotransferase [AST] and creatinine [CRE]. Biochemical value ranges assessed were below, within or above, as compared to baseline at Day 0.|At Day 30|The analysis was performed on the Total Vaccinated Cohort (TVC) which included all subjects with study vaccine administration documented.||Participants|||Count of Participants
634407|NCT02753413|Primary|Number of Subjects With Abnormal Biochemical Laboratory Values.|Among analysed biochemical parameters were alanine aminotransferase [ALT], aspartate aminotransferase [AST] and creatinine [CRE]. Biochemical value ranges assessed were below, within or above, as compared to baseline at Day 0.|At Day 7|The analysis was performed on the Total Vaccinated Cohort (TVC) which included all subjects with study vaccine administration documented.||Participants|||Count of Participants
634454|NCT02750267|Secondary|Hypoglycemia Area Under the Curve <70 mg/dL|All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.|72 hours||||||
634408|NCT02753075|Secondary|Change From Baseline in VRS of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse) at Week 8|Participants rated the intensity of their response to the evaporative (air) stimulus using a 10 point VRS. The Participants were asked to rate their pain on a scale of 1 (“No Pain”) to 10 (“Intense Pain”). A reduction in the score is indicative of an improvement in sensitivity.|Baseline, Week 8|ITT population included all participants who are randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.||score on a scale||Standard Deviation|Mean
634409|NCT02753075|Secondary|Change From Baseline in Visual Rating Scale (VRS) of Two Experimental Oral Rinses 1, 2 and a Placebo Oral Rinse at Week 4|Participants rated the intensity of their response to the evaporative (air) stimulus using a 10 point VRS. The Participants were asked to rate their pain on a scale of 1 (No Pain) to 10 (intense Pain). A reduction in the score is indicative of an improvement in sensitivity.|Baseline, Week 4|ITT population included all participants who are randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.||score on a scale||Standard Deviation|Mean
634410|NCT02753075|Secondary|Change From Baseline in Tactile Threshold (g) of Two Experimental Oral Rinses 1, 2 and a Placebo Oral Rinse at Week 8|The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force has reached. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g. However, in situations where participants did not give a ‘yes’ response at force of 80g, the tactile threshold was recorded as >80g. For analysis purposes values recorded as >80g were treated as 90g values.|Baseline, Week 8|ITT population included all participants who are randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.||g||Full Range|Median
634411|NCT02753075|Secondary|Change From Baseline in Tactile Threshold (Gram [g]) of Two Experimental Oral Rinses 1, 2 and a Placebo Oral Rinse at Week 4|The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force has reached. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g. However, in situations where participants did not give a ‘yes’ response at force of 80g, the tactile threshold was recorded as >80g. For analysis purposes values recorded as >80g were treated as 90g values.|Baseline, Week 4|ITT population included all participants who are randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.||g||Full Range|Median
634412|NCT02753075|Secondary|Change From Baseline in Schiff Sensitivity Score of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse at Week 4|The examiner assessed the participant's response to an evaporative air stimulus for each selected two teeth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicate improvement in sensitivity.|Baseline, Week 4|ITT population included all participants who are randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.||score on a scale||Standard Deviation|Mean
634413|NCT02753075|Secondary|Change From Baseline in Schiff Sensitivity Score of Two Experimental Oral Rinses 1 and 2 at Week 8|The examiner assessed the participant's response to an evaporative air stimulus for each selected two teeth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicate improvement in sensitivity.|Baseline, Week 8|ITT population included all participants who are randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.||score on a scale||Standard Deviation|Mean
634414|NCT02753075|Primary|Change From Baseline in Schiff Sensitivity Score of Experimental Oral Rinses 1 and 2 Against a Placebo Oral Rinse at Week 8|The examiner assessed the participant's response to an evaporative air stimulus for each selected two teeth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicate improvement in sensitivity.|Baseline, Week 8|Intent-to-treat (ITT) population included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.||score on a scale||Standard Deviation|Mean
634415|NCT02752802|Secondary|Assessment of Incidence of Serious Adverse Device Effect for Subjects Treated With the DyeVert System During the Procedure.|To assess the incidence of Serious Adverse Device Effect for subjects treated with the DyeVert System during the procedure for treatment subjects only.|All data will be collected on the day of the procedure, over an average of 12 hours.|Only treatments subjects were analyzed for this endpoint.||Number of Events|||Number
634416|NCT02752802|Secondary|Assessment of the Quality of Angiographic Images Between Groups|To assess the adequacy of the image quality. The proportion of images in which contrast opacification is deemed sufficient to evaluate the desired anatomical structures adequately will be compared between the DyeVert and control groups.|AlAll data will be collected on the day of the procedure, over an average of 12 hours.|||Images|Images||Count of Units
634455|NCT02750267|Secondary|Hypoglycemia Area Under the Curve <60|All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.|72 hours||||||
634417|NCT02752802|Primary|Evaluate the Total Volume of CM Used Comparing the DyeVert Group to the Control Group.|DyeVert is intended to reduce the total amount of contrast media (CM) administered during procedures requiring the injection of contrast media. Clinical evidence has demonstrated that CM can be toxic to the kidneys, leading to contrast induced nephropathy (CIN)|All data will be collected on the day of the procedure, over an average of 12 hours.|||ml||Standard Deviation|Mean
634418|NCT02751450|Secondary|Change From Baseline in Tactile Threshold on Day 3|The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gives two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g.|Baseline to Day 3|Analysis for this outcome was performed on intent-to-treat (ITT) population, defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment.||g||Standard Deviation|Mean
634419|NCT02751450|Secondary|Change From Baseline in Tactile Threshold Post First Treatment by Direct Application|The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gives two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g.|Baseline to 60 seconds post first treatment|Analysis for this outcome was performed on intent-to-treat (ITT) population, defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment.||g||Standard Deviation|Mean
634420|NCT02751450|Secondary|Change From Baseline in Schiff Sensitivity Score Post First Treatment by Direct Application|The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale which was scored as follows - 0: Participant does not respond to air stimulation; 1: Participant responded to air stimulus but does not request discontinuation of stimulus; 2: Participant responded to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus. A reduction in Schiff Sensitivity score was indicative of an improvement in sensitivity.|Baseline to 60 seconds post first treatment|Analysis for this outcome was performed on intent-to-treat (ITT) population, defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment.||Score on a Scale||Standard Deviation|Mean
634421|NCT02751450|Primary|Change From Baseline in Schiff Sensitivity Score on Day 3|The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale which was scored as follows - 0: Participant does not respond to air stimulation; 1: Participant responded to air stimulus but does not request discontinuation of stimulus; 2: Participant responded to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus. A reduction in Schiff Sensitivity score was indicative of an improvement in sensitivity.|Baseline to Day 3|Analysis for this outcome was performed on intent-to-treat (ITT) population, defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment.||Score on a scale||Standard Deviation|Mean
634456|NCT02750267|Secondary|Mean BG (as Measured by CGM)|All subjects have CGM and handheld glucose meter output analyzed and compared between time on closed-loop system and time on usual care period.|68 hours|||mg/dL||Standard Deviation|Mean
639121|NCT02406937|Secondary|Fecal Bacterium Concentration|bifidobacterium, lactobacillus, clostridium perfringens|Baseline, Day 21|||log (colony forming units)||Standard Deviation|Mean
634427|NCT02750813|Secondary|Ex Vivo Critical Coefficient of Friction (CCOF) at Day 14|The ex vivo CCOF (ratio of the force of friction between two bodies and the force pressing them together) was measured by the incline plane technique after 16 hours of lens wear. Worn lenses were collected and analyzed for a subset of subjects (all subjects from one site only) who attended the Day 14 visit (Visit 2 and Visit 3) after 16 hours of lens wear. Only lens worn on the right eye (OD) was measured in each subject per each lens brand. CCOF values for contact lenses range from near zero to approximately 0.10 using the inclined plane method. A lower CCOF indicates higher contact lens lubricity.|Day 14, each product|Full Analysis Set. Number Analyzed is the number of eyes with non-missing responses, including only subjects from one site.||unitless|Eyes|Standard Deviation|Mean
634428|NCT02750813|Primary|Percentage of Lenses Graded as 0 or 1 for Lens Centration at Day 14|"Lens centration, was assessed by the investigator for each eye individually and rated on a 5-point scale: 0=centered/optimal, 1=slight decentration, 2=mild decentration, 3=moderate decentration, 4=severe decentration. The combined percentage of lenses assessed as centered or slight decentration is reported. Lenses from both eyes contributed to the percentage."|Day 14, each product|Full Analysis Set. Number Analyzed is the number of eyes with non-missing response.||percentage of lenses|Eyes||Number
634429|NCT02750709|Secondary|Apparent Terminal Half-life (t1/2)||0, 0.25, 0.50, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 hours|All subjects for whom the primary PK parameters Cmax and AUC(0-120) could be calculated for at least 2 treatment periods (where one of the treatment periods is the Reference product), and who had no major protocol deviations thought to impact on the analysis of the PK data were included in the statistical PK analysis for the study.||hr||Geometric Coefficient of Variation|Geometric Mean
634430|NCT02750709|Secondary|Terminal Elimination Rate Constant (λz)||0, 0.25, 0.50, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 hours|All subjects for whom the primary PK parameters Cmax and AUC(0-120) could be calculated for at least 2 treatment periods (where one of the treatment periods is the Reference product), and who had no major protocol deviations thought to impact on the analysis of the PK data were included in the statistical PK analysis for the study.||1/hr||Geometric Coefficient of Variation|Geometric Mean
634431|NCT02750709|Secondary|Time to Maximum Observed Plasma Concentration (Tmax)||0, 0.25, 0.50, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 hours|All subjects for whom the primary PK parameters Cmax and AUC(0-120) could be calculated for at least 2 treatment periods (where one of the treatment periods is the Reference product), and who had no major protocol deviations thought to impact on the analysis of the PK data were included in the statistical PK analysis for the study.||hr||Full Range|Median
634432|NCT02750709|Secondary|Area Under the Plasma Concentration Versus Time Curve, With Extrapolation to Infinity (AUC(0-∞)||0, 0.25, 0.50, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 hours|All subjects for whom the primary PK parameters Cmax and AUC(0-120) could be calculated for at least 2 treatment periods (where one of the treatment periods is the Reference product), and who had no major protocol deviations thought to impact on the analysis of the PK data were included in the statistical PK analysis for the study.||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
634433|NCT02750709|Secondary|Area Under the Plasma Concentration Versus Time Curve, From Time Zero to 72 Hours Post-dose (AUC(0-72))||0, 0.25, 0.50, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours post-dose|All subjects for whom the primary PK parameters Cmax and AUC(0-120) could be calculated for at least 2 treatment periods (where one of the treatment periods is the Reference product), and who had no major protocol deviations thought to impact on the analysis of the PK data were included in the statistical PK analysis for the study.||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
634434|NCT02750709|Primary|Area Under the Plasma Concentration Versus Time Curve, From Time Zero to 120 Hours Post-dose (AUC(0-120))||0, 0.25, 0.50, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 hours|All subjects for whom the primary PK parameters Cmax and AUC(0-120) could be calculated for at least 2 treatment periods (where one of the treatment periods is the Reference product), and who had no major protocol deviations thought to impact on the analysis of the PK data were included in the statistical PK analysis for the study.||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
634435|NCT02750709|Primary|Maximum Observed Plasma Concentration (Cmax)||0, 0.25, 0.50, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 hours|All subjects for whom the primary PK parameters Cmax and AUC(0-120) could be calculated for at least 2 treatment periods (where one of the treatment periods is the Reference product), and who had no major protocol deviations thought to impact on the analysis of the PK data were included in the statistical PK analysis for the study.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
639122|NCT02406937|Secondary|Fecal Laboratory Detection for sIgA||Baseline, Day 84|||ug/ml||Standard Deviation|Mean
634436|NCT02750345|Secondary|Apparent Terminal Elimination Half-life (t1/2)||0 - 120 hours post-dose|All subjects for whom the primary pk parameters Cmax and AUC (0-120) could be calculated for at least 2 treatment periods (where one of which must be the reference product), and who had no major protocol deviations thought to impact on the analysis of pk data were included in the statistical pk analysis for the study.||hr||Geometric Coefficient of Variation|Geometric Mean
634437|NCT02750345|Secondary|Terminal Elimination Rate Constant (λz)||0 - 120 hours post-dose|All subjects for whom the primary pk parameters Cmax and AUC (0-120) could be calculated for at least 2 treatment periods (where one of which must be the reference product), and who had no major protocol deviations thought to impact on the analysis of pk data were included in the statistical pk analysis for the study||1/hr||Geometric Coefficient of Variation|Geometric Mean
634438|NCT02750345|Secondary|Time to Maximum Observed Plasma Concentration (Tmax)||0 - 120 hours post-dose|All subjects for whom the primary pk parameters Cmax and AUC (0-120) could be calculated for at least 2 treatment periods (where one of which must be the reference product), and who had no major protocol deviations thought to impact on the analysis of pk data were included in the statistical analysis for the study.||hr||Full Range|Median
634439|NCT02750345|Secondary|Area Under the Plasma Concentration Versus Time Curve, With Extrapolation to Infinity (AUC(0-∞))||0 - 120 hours post-dose|All subjects for whom the primary pk parameters Cmax and AUC (0-120) could be calculated for at least 2 treatment periods (where one of which is the reference product), and who had no major protocol deviations thought to impact on the analysis of pk data were included in the statistical pk analysis for the study||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
634440|NCT02750345|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC(0-72))||0 - 72 hours post-dose|All subjects for whom the primary pk parameters Cmax and AUC (0-120) could be calculated for at least 2 treatment periods (where one of the treatment periods must be the reference product), and who had no major protocol deviations thought to impact on the analysis of the pk data were included in the statistical pk analysis for the study.||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
634441|NCT02750345|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC(0-120))||0 - 120 hours post-dose|All subjects for whom the primary Pk parameters Cmax and AUC (0-120) could be calculated for at least 2 treatment periods (where one of the treatment includes the reference product), and who had no major protocol deviations thought to impact the analysis of the pk data were included for the statistical pk analysis for the study.||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
634442|NCT02750345|Primary|Maximum Observed Plasma Concentration (Cmax)||0 - 120 hours post-dose|All subjects for whom the primary pk parameters Cmax and AUC (0-120) could be calculated for at least two treatment periods (where one of which is the reference product), and who had no major protocol deviations thought to impact on the analysis of pk data were included in the statistical pk analysis for the study.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
634443|NCT02750332|Secondary|Apparent Terminal Elimination Half-life (t1/2)||0 - 120 hours post-dose|All subjects for whom the primary PK parameters Cmax and AUC(0-120) could be calculated for at least 2 treatment periods (where one of the treatment periods is the Reference product), and who had no major protocol deviations thought to impact on the analysis of the PK data were included in the statistical PK analysis for the study.||hr||Geometric Coefficient of Variation|Geometric Mean
634444|NCT02750332|Secondary|Terminal Elimination Rate Constant (λz)||0 - 120 hours post-dose|All subjects for whom the primary PK parameters Cmax and AUC(0-120) could be calculated for at least 2 treatment periods (where one of the treatment periods is the Reference product), and who had no major protocol deviations thought to impact on the analysis of the PK data were included in the statistical PK analysis for the study.||1/hr||Geometric Coefficient of Variation|Geometric Mean
634445|NCT02750332|Secondary|Time to Maximum Observed Plasma Concentration (Tmax)||0 - 120 hours post-dose|All subjects for whom the primary PK parameters Cmax and AUC(0-120) could be calculated for at least 2 treatment periods (where one of the treatment periods is the Reference product), and who had no major protocol deviations thought to impact on the analysis of the PK data were included in the statistical PK analysis for the study.||hr||Full Range|Median
634446|NCT02750332|Secondary|Area Under the Plasma Concentration Versus Time Curve, With Extrapolation to Infinity (AUC(0-∞))||0 - 120 hours post-dose|All subjects for whom the primary PK parameters Cmax and AUC(0-120) could be calculated for at least 2 treatment periods (where one of the treatment periods is the Reference product), and who had no major protocol deviations thought to impact on the analysis of the PK data were included in the statistical PK analysis for the study.||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
634447|NCT02750332|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC(0-72))||0 - 72 hours post-dose|All subjects for whom the primary PK parameters Cmax and AUC(0-120) could be calculated for at least 2 treatment periods (where one of the treatment periods is the Reference product), and who had no major protocol deviations thought to impact on the analysis of the PK data were included in the statistical PK analysis for the study.||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
634448|NCT02750332|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC(0-120))||0 - 120 hours post-dose|All subjects for whom the primary PK parameters Cmax and AUC(0-120) could be calculated for at least 2 treatment periods (where one of the treatment periods is the Reference product), and who had no major protocol deviations thought to impact on the analysis of the PK data were included in the statistical PK analysis for the study.||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
634449|NCT02750332|Primary|Maximum Observed Plasma Concentration (Cmax)||0 - 120 hours post-dose|All subjects for whom the primary PK parameters Cmax and AUC(0-120) could be calculated for at least 2 treatment periods (where one of the treatment periods is the Reference product), and who had no major protocol deviations thought to impact on the analysis of the PK data were included in the statistical PK analysis for the study.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
634450|NCT02750267|Secondary|End of Night Blood Glucose|All subjects have blood glucose evaluated upon rising (approximately 7 am) and compared between time on closed-loop system and time on usual care period.|72 hours||||||
634451|NCT02750267|Secondary|Incidence of Hypoglycemia Per Subject, Defined by Handheld Meter Glucose <70 mg/dL|All subjects have hypoglycemia monitored by meter analysis and compared between time on closed-loop system and time on usual care period.|68 hours|||events per subject, glucometer <70mg/dL||Standard Deviation|Mean
639123|NCT02406937|Secondary|Number of Participants With Eczema||Throughout the study period (84 days)|||participants|||Number
634460|NCT02750267|Secondary|Distribution of Sensor and Meter Glucose Values (Maximum, Minimum, Median, Interquartile Range, Mean, Standard Deviation)|All subjects have CGM and handheld glucose meter output analyzed and compared between time on closed-loop system and time on usual care period.|72 hours||||||
634461|NCT02750267|Secondary|Percent of Time Sensor Glucose Readings Are >400 mg/dL|All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.|72 hours||||||
634462|NCT02750267|Secondary|Percent of Time Sensor Glucose Readings Are >250 mg/dL|All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.|68 hours|||percentage of time above 250 mg/dL||Standard Deviation|Mean
634463|NCT02750267|Secondary|Percent of Time Sensor Glucose Readings Are >180 mg/dL|All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.|68 hours|||percentage of time above 180 mg/dL||Standard Deviation|Mean
634464|NCT02750267|Secondary|Percent of Time Sensor Glucose Readings Are >150 mg/dL|All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.|72 hours||||||
634465|NCT02750267|Secondary|Percent of Time Sensor Glucose Readings Are <70 mg/dL|All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.|68 hours|||percentage of time below 70 mg/dL||Standard Deviation|Mean
634466|NCT02750267|Primary|Percent of Sensor Glucose Readings Between 70-180 mg/dL|All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.|68 hours|||percentage of time in range||Standard Deviation|Mean
634467|NCT02748213|Secondary|Duration of Response (DOR) According to RECIST|Tumor response was assessed by RECIST during the study. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels. PR was defined as ≥30% decrease in sum LD of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. DOR was defined as the time from first assessment of CR or PR until the first occurrence of documented PD, death, or withdrawal. The median DOR was reported and expressed in months.|Tumor assessments at Baseline, then every 6 weeks until Cycle 8 (cycle length of 21 days), then every 12 weeks until progressive disease and/or one year after enrollment; thereafter according to routine clinical practice (up to 66 months overall)|"FAS Population. The Number of Participants Analyzed reflects the number of participants with a best overall response of CR or PR who provided evaluable data for the analysis."||months||Full Range|Median
634468|NCT02748213|Secondary|Overall Survival (OS)|OS was defined as the time from start of treatment to date of death for any reason. Participants who were alive at the time of analysis were censored at the latest date of last tumor assessment, last drug intake, or last follow-up information. The median duration of OS and corresponding 95% CI were estimated by Kaplan-Meier analysis and expressed in months.|Continuously during treatment (up to 66 months) and at any time after treatment discontinuation until 18 months after last participant enrolled (up to 66 months overall)|FAS Population.||months||95% Confidence Interval|Median
634469|NCT02748213|Secondary|Percentage of Participants Who Died|The percentage of participants who died from any cause was reported.|Continuously during treatment (up to 66 months) and at any time after treatment discontinuation until 18 months after last participant enrolled (up to 66 months overall)|FAS Population.||percentage of participants|||Number
634470|NCT02748213|Secondary|Progression-Free Survival (PFS) According to RECIST|Tumor response was assessed by RECIST during the study. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-treatment sum LD, or the appearance of new lesions. PFS was defined as the time from start of treatment to the first event of death or PD. Participants without event at the time of analysis were censored at the latest date of last tumor assessment or last date in drug log. The median duration of PFS and corresponding 95% CI were estimated by Kaplan-Meier analysis and expressed in months.|Tumor assessments at Baseline, then every 6 weeks until Cycle 8 (cycle length of 21 days), then every 12 weeks until progressive disease and/or one year after enrollment; thereafter according to routine clinical practice (up to 66 months overall)|FAS Population.||months||95% Confidence Interval|Median
634471|NCT02748213|Secondary|Percentage of Participants With Death or Disease Progression According to RECIST|Tumor response was assessed by RECIST during the study. Disease progression or progressive disease (PD) was defined as ≥20% increase in sum LD in reference to the smallest on-treatment sum LD, or the appearance of new lesions. The percentage of participants who died or experienced PD was reported.|Tumor assessments at Baseline, then every 6 weeks until Cycle 8 (cycle length of 21 days), then every 12 weeks until progressive disease and/or one year after enrollment; thereafter according to routine clinical practice (up to 66 months overall)|FAS Population.||percentage of participants|||Number
634472|NCT02748213|Primary|Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST)|Tumor response was assessed by RECIST during the study. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels. PR was defined as greater than or equal to (≥) 30 percent (%) decrease in sum of longest diameter (LD) of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. The percentage of participants with a best overall response for CR or PR was reported. The exact 95% confidence interval (CI) for one-sample binomial was determined using the Pearson-Clopper method.|Tumor assessments at Baseline, then every 6 weeks until Cycle 8 (cycle length of 21 days), then every 12 weeks until progressive disease and/or one year after enrollment; thereafter according to routine clinical practice (up to 66 months overall)|Full Analysis Set (FAS) Population.||percentage of participants||95% Confidence Interval|Number
634473|NCT02746679|Secondary|The Scores of General Health Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)|The 36-item Short-Form Health Survey (SF-36) is a commonly used generic questionnaire that includes 36 items clustered into eight dimensions (bodily pain, general health, mental health, physical functioning,role-emotional, role-physical, social functioning, and vitality). The item scores for each dimension are coded, summed and transformed to a scale from 0(worst possible health status) to 100 (best possible health status). Each raw scale score is linearly transformed to t scores. The transformed scores range from 0 to 100; higher scores indicate a better health-related QoL.|Baseline and 8 weeks|||units on a scale(t scores)||Standard Deviation|Mean
639124|NCT02406937|Secondary|Body Length|Body length|Baseline, Day 28, Day 56, Day 84|||cm||Standard Deviation|Mean
634474|NCT02746679|Secondary|The Scores of Bodily Pain Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)|The 36-item Short-Form Health Survey (SF-36) is a commonly used generic questionnaire that includes 36 items clustered into eight dimensions (bodily pain, general health, mental health, physical functioning,role-emotional, role-physical, social functioning, and vitality). The item scores for each dimension are coded, summed and transformed to a scale from 0(worst possible health status) to 100 (best possible health status). Each raw scale score is linearly transformed to t scores. The transformed scores range from 0 to 100; higher scores indicate a better health-related QoL.|Baseline and 8 weeks|||units on a scale(t scores)||Standard Deviation|Mean
634475|NCT02746679|Secondary|The Scores of Social Functioning Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)|The 36-item Short-Form Health Survey (SF-36) is a commonly used generic questionnaire that includes 36 items clustered into eight dimensions (bodily pain, general health, mental health, physical functioning,role-emotional, role-physical, social functioning, and vitality). The item scores for each dimension are coded, summed and transformed to a scale from 0(worst possible health status) to 100 (best possible health status). Each raw scale score is linearly transformed to t scores. The transformed scores range from 0 to 100; higher scores indicate a better health-related QoL.|Baseline and 8 weeks|||units on a scale(t scores)||Standard Deviation|Mean
634476|NCT02746679|Secondary|The Scores of Mental Health Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)|The 36-item Short-Form Health Survey (SF-36) is a commonly used generic questionnaire that includes 36 items clustered into eight dimensions (bodily pain, general health, mental health, physical functioning,role-emotional, role-physical, social functioning, and vitality). The item scores for each dimension are coded, summed and transformed to a scale from 0(worst possible health status) to 100 (best possible health status). Each raw scale score is linearly transformed to t scores. The transformed scores range from 0 to 100; higher scores indicate a better health-related QoL.|Baseline and 8 weeks|||units on a scale(t scores)||Standard Deviation|Mean
634477|NCT02746679|Secondary|The Scores of Vitality Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)|The 36-item Short-Form Health Survey (SF-36) is a commonly used generic questionnaire that includes 36 items clustered into eight dimensions (bodily pain, general health, mental health, physical functioning,role-emotional, role-physical, social functioning, and vitality). The item scores for each dimension are coded, summed and transformed to a scale from 0(worst possible health status) to 100 (best possible health status). Each raw scale score is linearly transformed to t scores. The transformed scores range from 0 to 100; higher scores indicate a better health-related QoL.|Baseline and 8 weeks|||units on a scale(t scores)||Standard Deviation|Mean
634478|NCT02746679|Secondary|The Scores of Role-emotional Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)|The 36-item Short-Form Health Survey (SF-36) is a commonly used generic questionnaire that includes 36 items clustered into eight dimensions (bodily pain, general health, mental health, physical functioning,role-emotional, role-physical, social functioning, and vitality). The item scores for each dimension are coded, summed and transformed to a scale from 0(worst possible health status) to 100 (best possible health status). Each raw scale score is linearly transformed to t scores. The transformed scores range from 0 to 100; higher scores indicate a better health-related QoL.|Baseline and 8 weeks|||units on a scale(t scores)||Standard Deviation|Mean
634479|NCT02746679|Secondary|The Scores of Role-physical Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)|The 36-item Short-Form Health Survey (SF-36) is a commonly used generic questionnaire that includes 36 items clustered into eight dimensions (bodily pain, general health, mental health, physical functioning,role-emotional, role-physical, social functioning, and vitality). The item scores for each dimension are coded, summed and transformed to a scale from 0(worst possible health status) to 100 (best possible health status). Each raw scale score is linearly transformed to t scores. The transformed scores range from 0 to 100; higher scores indicate a better health-related QoL.|Baseline and 8 weeks|||units on a scale(t scores)||Standard Deviation|Mean
634480|NCT02746679|Secondary|The Scores of Physical Function Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)|The 36-item Short-Form Health Survey (SF-36) is a commonly used generic questionnaire that includes 36 items clustered into eight dimensions (bodily pain, general health, mental health, physical functioning,role-emotional, role-physical, social functioning, and vitality). The item scores for each dimension are coded, summed and transformed to a scale from 0(worst possible health status) to 100 (best possible health status). Each raw scale score is linearly transformed to t scores. The transformed scores range from 0 to 100; higher scores indicate a better health-related QoL.|Baseline and 8 weeks|||units on a scale(t scores)||Standard Deviation|Mean
634481|NCT02746679|Secondary|The Zung Self-Rating Depression Scale Scores Before and After the Intervention|The full name of the scale called Zung Self-Rating Depression Scale.The ZSDS includes 10 positively worded items and 10 negatively worded items that assess symptoms of depression. Item responses are ranked from 1 to 4, and higher scores correspond to more frequent symptoms. For each item,patients give a score according to whether the item has occurred: 1 = never/very rarely; 2 = once in a while/some of the time/occasionally; 3 = relatively often/very often/often; 4 = most of the time/always. Each items points accumulated as raw scores,the lowest raw score is 20 points, the highest raw score is 80 points. The raw scores multiply by 1.25, taking the integer part as the standard scores.The ZSDS standard scores were used to define four categories of depression severity: within normal range or no significant psychopathology (below 51points); presence of minimal to mild depression (51-60points); presence of moderate to marked depression (61-70points).|Baseline and 8 weeks|||units on a scale(raw scores)||Standard Deviation|Mean
634482|NCT02746679|Secondary|Numbers of Participants With Reformation of Intrauterine Adhesions Were Counted by the Follow-up Hysteroscopy Was Performed in the Third Month After the Surgery||3 months|||participants|||Number
634483|NCT02746679|Secondary|Menstruation Was Evaluated With Visual Analogue Scale (VAS) in Which the Menstruation Was Assessed by the Patients Themselves With 0 as Amenorrhea and 100 as Normal Menstruation||3 months|||units on a scale||Standard Deviation|Mean
634484|NCT02746679|Secondary|Endometrial Thickness Were Measured by Ultrasound in the Middle of Menstruation in All Patients.||3 months|||mm||Standard Deviation|Mean
634629|NCT02721277|Other Pre-specified|Numbers of Blood Infection Obtained From a Central Venous Catheter|A review of the subject's medical record will determine the location from which positive blood cultures were obtained.|6 months|Study was terminated due to insufficient enrollment|||||
634485|NCT02746679|Primary|The Zung Self-Rating Anxiety Scale Scores Before and After the Intervention|The full name of the scale called Zung Self-Rating Anxiety Scale.The ZSAS contains 20 questions. Each question is scored on a scale of 1-4 (never, some of the time, relatively often, most of the time). Fifteen questions involve the assessment of increasing anxiety levels, and five questions involve decreasing anxiety levels.Each items points accumulated as raw scores,the lowest raw score is 20 points, the highest raw score is 80 points. The raw scores multiply by 1.25, taking the integer part as the standard scores.The ZSAS standard scores were used to define four categories of anxiety severity: within normal rangeor no significant psychopathology (25-49points);presence of mild to moderate anxiety levels (50-59points); severe anxiety levels (60-69points); and presence of extreme depression (70-100points).|Baseline and 8 weeks|||units on a scale(raw scores)||Standard Deviation|Mean
634486|NCT02746406|Primary|Usability Factors; Simple, Doable, and is Comparable to the Ruler-based Manometry Method Using a Questionnaire and Patient Diary.|Each participant could score between 0 and 39 and the total score range for group is 0 to 195. All questionnaires and patient diary questions were summed across the board for patients to derive a total score for the Arm/Group|Through study completion, an average of 4 days|||participants|||Number
634487|NCT02746107|Other Pre-specified|Number of Participants Who Prescribed Oral Anticoagulants (OAC) According to the CHA2D2s-VASC Risk Score|The proportion of OAC prescription for the range 1-5 of CHA2D2s-VASC scores. CHA2D2S-VASC risk score ranges from 1-5, with higher scores indicating a greater risk of stroke.|5 min|||participants|||Number
634488|NCT02746107|Other Pre-specified|Number of Participants Who Prescribed Oral Anticoagulants (OAC) According to the Target of Prescription (Patient vs. Physician Himself)|the participant physicians were randomized to prescribe to virtual patients or to imagine that the risk seen in the diagram was that of themselves|5 min|||participants|||Number
634489|NCT02746107|Other Pre-specified|Number of Participants Who Prescribed Oral Anticoagulants (OAC) According to the Timeframe for Risk Presentation (1 vs 5 Years)|the proportion of physicians deciding to prescribe OAC after seeing risk estimation on 1 vs 5 years|5 minutes|||participants|||Number
634490|NCT02746107|Primary|Number of Participants Who Prescribed Oral Anticoagulants (OAC) According to the Number of Decision Aid Diagrams|after regarding the risk diagram, the physician will decide to prescribe/take or not the treatment|after seeing the decision aid (5 min)|||participants|||Number
634491|NCT02745626|Secondary|Amount of Root Resorption Observed for Maxillary Second Premolar = Length of Root at T0-Length of Root at T2 (in mm)|Root resorption was analyzed by comparing the root length before (T0) treatment and after 18 months of treatment( T2)|T0-T2: 18 months of treatment|||millimeter (mm)||Standard Deviation|Mean
634492|NCT02745626|Secondary|Amount of Root Resorption Observed for Maxillary Lateral Incisor = Length of Root at T0-Length of Root at T2 (in mm)|Root resorption was analyzed by comparing the root length before (T0) treatment and after 18 months of treatment( T2). Therefore the data values indicate the difference in the root length ( in mm).|T0-T2: 18 months of treatment|||millimeter (mm)||Standard Deviation|Mean
634493|NCT02745626|Secondary|S.Mutans Count|To calculate the bacterial counts from the diluted plates back to baseline undiluted values, the measurement obtained from the diluted plate was multiplied by 10n (n = number of the serial dilution)|T0: Before treatment; T1: 9 months of treatment; T2: 18 months of treatment|||CFU/ml||Standard Deviation|Mean
634494|NCT02745626|Secondary|Total Bacterial Count|To calculate the bacterial counts from the diluted plates back to baseline undiluted values, the measurement obtained from the diluted plate was multiplied by 10n (n = number of the serial dilution).|T0: Before treatment; T1: 9 months of treatment; T2: 18 months of treatment|||CFU/ml||Standard Deviation|Mean
634495|NCT02745626|Secondary|Bleeding Index|"An evaluation of the amount of inflammation.
The following scores were used:
0 no bleeding
singular bleeding point
several bleeding points or a thin bleeding line along the marginal gingiva
bleeding in the entire interdental gingival triangle immediately after probing
profuse bleeding during probing, bleeding extending over the marginal gingiva eventually with development of blood drops"|T0: Before treatment; T1: 9 months of treatment; T2: 18 months of treatment|||Bleeding index (BI)||Standard Deviation|Mean
634496|NCT02745626|Secondary|Gingival Index|"An evaluation of the gingival architecture . The following scores were used :
0 Physiologic gingiva
Mild inflammation (slight color change and little change in texture)
Moderate inflammation (moderate glazing, redness, edema and hypertrophy, bleeding on probing)
Severe inflammation (marked redness and hypertrophy, ulceration. tendency to bleed spontaneously)"|T0: Before treatment; T1: 9 months of treatment; T2: 18 months of treatment|||Gingival Index (GI)||Standard Deviation|Mean
634497|NCT02745626|Primary|Plaque Index|"A measure of the plaque levels on the desired tooth surface. The following scores were used:
0 no plaque/debris on inspection and probing
thin film of plaque only visible after probing
ribbon-like layer of plaque covering the sulcus & gingival crown areas but not filling interdental space
thick layer of plaque already visible at inspection and filling interdental space"|T0: Before treatment; T1: 9 months of treatment; T2: 18 months of treatment|||Plaque Index (PI)||Standard Deviation|Mean
634498|NCT02743936|Secondary|Patient Discomfort (Verbal Numerical Rating Scale)|Discomfort scored on a 0-10 verbal numerical rating scale (0 = no discomfort, 10 = most discomfort imaginable)|After study completion (approximately 2 minutes after study start)|||Scores on verbal numerical rating scale||Inter-Quartile Range|Median
634499|NCT02743936|Primary|Face Mask Leak Measured in Liters Per Minute by the Noninvasive Positive Pressure Ventilation Machine|Face mask leak as measured in liters per minute by the noninvasive positive pressure ventilation machine|2 minutes after mask placement|||Liters per minute||Inter-Quartile Range|Median
634500|NCT02743780|Secondary|Part 3: Observed Concentration at 12 Hours Following Drug Administration [C12 (ng/mL)]|Based on plasma samples collected at pre-determined nominal time points, dependent on observed concentrations. Approximately 2 mL of venous blood was collected at each time point. C12 is reported as mass/volume.|Up to Day 8|PK Analysis Set. Number Analyzed is the number of subjects with data at visit.||ng/mL||Standard Deviation|Mean
634501|NCT02743780|Secondary|Part 2: Accumulation Ratio (Racc)|Accumulation Ratio was derived using Cmax on Day 7 versus Cmax on Day 1. Approximately 2 mL of venous blood was collected at each time point.|Day 7|PK Analysis Set. Number Analyzed is the number of subjects with data at visit.||ng/mL||Standard Deviation|Mean
634630|NCT02721277|Other Pre-specified|Numbers of Blood Infection Obtained From a Venipuncture|A review of the subject's medical record will determine the location from which positive blood cultures were obtained.|6 months|Study was terminated due to insufficient enrollment|||||
634502|NCT02743780|Secondary|Part 2: Area Under the Concentration-time Curve From 0 to the End of the Dosing Interval Tau [AUCtau (ng*h/mL)]|Based on plasma samples collected at pre-determined nominal time points, dependent on observed concentrations. Approximately 2 mL of venous blood was collected at each time point. AUCtau is reported as mass*time/volume.|Up to Day 7|PK Analysis Set. Number Analyzed is the number of subjects with data at visit.||ng*h/mL||Standard Deviation|Mean
634503|NCT02743780|Secondary|Part 2: Time to Reach Maximum Concentration [Tmax (h)]|Based on plasma samples collected at pre-determined nominal time points, dependent on observed concentrations. Approximately 2 mL of venous blood was collected at each time point.|Up to Day 7|PK Analysis Set. Number Analyzed is the number of subjects with data at visit.||hours||Full Range|Median
634504|NCT02743780|Secondary|Part 2: Maximum Observed Concentration [Cmax (ng/mL)]|Based on plasma samples collected at pre-determined nominal time points, dependent on observed concentrations. Approximately 2 mL of venous blood was collected at each time point. Cmax is reported as mass/volume.|Up to Day 7|PK Analysis Set. Number Analyzed is the number of subjects with data at visit.||ng/mL||Standard Deviation|Mean
634505|NCT02743780|Secondary|Part 1: Terminal Elimination Half-life [t1/2 (h)]|Based on plasma samples collected at pre-determined nominal time points, dependent on observed concentrations. Approximately 2 mL of venous blood was to be collected at each time point.|Pre-dose to 120 hours post-dose|Due to the low exposure and the limit of LLOQ (0.05 ng/mL), none of the observed individual profiles could generate valid t1/2.|||||
634506|NCT02743780|Secondary|Part 1: Area Under the Concentration-time Curve From 0 to Infinity [AUCinf (ng*h/mL)]|Based on plasma samples collected at pre-determined nominal time points, dependent on observed concentrations. Approximately 2 mL of venous blood was to be collected at each time point.|Pre-dose to 120 hours post-dose|Due to the low exposure and the limit of LLOQ (0.05 ng/mL), none of the observed individual profiles could generate valid AUCinf.|||||
634507|NCT02743780|Secondary|Part 1: Area Under the Plasma Concentration-time Curve From Time Zero to 120 Hours Post Dose [AUC0-120 (ng*h/mL)]|Based on plasma samples collected at pre-determined nominal time points, dependent on observed concentrations. Approximately 2 mL of venous blood was to be collected at each time point.|Pre-dose to 120 hours post-dose|Due to the low exposure and the limit of the lower limit of quantitation (LLOQ) (0.05 ng/mL), none of the observed individual profiles could generate valid AUC0-120.|||||
634508|NCT02743780|Secondary|Part 1: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUClast (ng*h/mL)]|Based on plasma samples collected at pre-determined nominal time points, dependent on observed concentrations. Approximately 2 mL of venous blood was collected at each time point. AUClast is reported as mass*time/volume.|Pre-dose, .5, 2, 4, 6, 12, 24, 48, 72, 96, 120 hours post-dose, and Day 7 post-dose|PK Analysis Set. Number Analyzed is the number of subjects with data at visit.||ng*h/mL||Standard Deviation|Mean
634509|NCT02743780|Secondary|Part 1: Time to Reach Maximum Concentration [Tmax (h)]|Based on plasma samples collected at pre-determined nominal time points, dependent on observed concentrations. Approximately 2 mL of venous blood was collected at each time point.|Pre-dose, .5, 2, 4, 6, 12, 24, 48, 72, 96, 120 hours post-dose, and Day 7 post-dose|PK Analysis Set. Number Analyzed is the number of subjects with data at visit.||hours||Full Range|Median
634510|NCT02743780|Secondary|Part 1: Maximum Observed Concentration [Cmax (ng/mL)]|Based on plasma samples collected at pre-determined nominal time points, dependent on observed concentrations. Approximately 2 mL of venous blood was collected at each time point. Cmax is reported as mass/volume.|Pre-dose, .5, 2, 4, 6, 12, 24, 48, 72, 96, 120 hours post-dose, and Day 7 post-dose|This analysis population includes all subjects who received IP, had at least 1 plasma sample following exposure to non-placebo IP and had no known specimen collection or analytical deviations which would affect the integrity of the data (Pharmacokinetic (PK) Analysis Set). Number Analyzed is the number of subjects with data at visit.||ng/mL||Standard Deviation|Mean
634511|NCT02743780|Secondary|Part 3: Change From Baseline in IOP at 36 Hours and 48 Hours Post Day 7 Administration|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. Baseline IOP was the average of IOP measurements obtained at the 2 eligibility visits. Change from baseline was calculated by taking the change at each time point from baseline to Day 8 and averaging the available changes. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. Only one eye (study eye) contributed to the analysis.|Baseline, up to Day 9|Full Analysis Set||mmHg||Standard Deviation|Mean
634512|NCT02743780|Primary|Part 3: Change in IOP From Baseline to Day 8 at 8 AM, 10 AM, Noon, 4 PM, and 8 PM|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. Baseline IOP was the average of IOP measurements obtained at the 2 eligibility visits. Change from baseline was calculated by taking the change at each time point from baseline to Day 8. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. Only one eye (study eye) contributed to the analysis.|Baseline, Day 8|Full Analysis Set||mmHg||Standard Error|Least Squares Mean
634513|NCT02743780|Primary|Part 3: Change in Diurnal IOP (Averaged Over 8 AM, 10 AM, Noon, 4 PM, and 8 PM) From Baseline to Day 8|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. Diurnal IOP was defined as the average of the five time points measured (8 AM, 10 AM, noon, 4 PM, and 8 PM). Baseline diurnal IOP was the average of IOP measurements obtained at the 2 eligibility visits. Change from baseline was calculated by taking the change at each time point from baseline to Day 8 and averaging the available changes. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. Only one eye (study eye) contributed to the analysis.|Baseline, Day 8|Full Analysis Set||mmHg||Standard Error|Least Squares Mean
634514|NCT02743702|Primary|Change From Baseline Vital Capacity at One Year.|Change from Baseline vital capacity at one year evaluated by spirometer.|At baseline and at 1 year|||percentage of Change of vital capacity||Inter-Quartile Range|Median
634515|NCT02743117|Secondary|Percentage of Participants Who Require Antipyretic and/or Analgesic Medication|Percentage of participants who require antipyretic and/or analgesic medication were reported.|Baseline (Day 1) up to Day 8 and Day 15|The ITT population included all participants that were randomized and treated with investigational product.||Percentage of participants|||Number
634549|NCT02736721|Primary|Number of Participants With Molecular Response (MR)|MR was assessed using breakpoint cluster region - Abelson (BCR-ABL) proto-oncogene transcript levels measured by RT-PCR from peripheral blood. Number of participants with BCR-ABL/ABL ratio less than or equal to 10 (%) was reported.|Up to approximately 7 years|Analysis population included all enrolled participants.||participants|||Number
634516|NCT02743117|Secondary|Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) and New Onset Chronic Diseases (NOCDs)|An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent SAEs were serious events between administration of study drug and up to 181 days after the dose that are absent before treatment or that worsen relative to pretreatment state. An NOCD is a newly diagnosed medical condition that is of a chronic, ongoing nature and is assessed by the investigator as medically significant. Results were given for TESAEs and NOCDs reported up to 29 days and 181 days after vaccination.|Baseline (Day 1) up to Day 29 and Day 181|The ITT population included all participants that were randomized and treated with investigational product.||Participants|||Number
634517|NCT02743117|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs were events between administration of study drug and up to 15 days after vaccination that are absent before treatment or that worsened relative to pre-treatment state. Results were given for AEs reported up to 8 days and 15 days after vaccination.|Baseline (Day 1) up to Day 8 and Day 15|The ITT population included all participants that were randomized and treated with investigational product.||Participants|||Number
634518|NCT02743117|Secondary|Percentage of Participants With Solicited Symptoms|Solicited symptoms are predefined symptoms or events specifically inquired about and assessed daily after vaccine administration up to 15 days after vaccination. The solicited symptoms include fever greater than (>) 100.0 degrees F (37.8 degrees Celsius), runny nose, sore throat, cough, vomiting, muscle aches, chills, decreased activity and headache. Results were reported for all solicited symptoms except fever >=101 degrees F (reported as primary outcome) up to 8 days after vaccination and all solicited symptoms up to 15 days after vaccination.|Baseline (Day 1) up to Day 8 and Day 15|The ITT population included all participants that were randomized and treated with investigational product.||Percentage of participants|||Number
634519|NCT02743117|Primary|Percentage of Participants With Fever Greater Than or Equal to (>=) 101 Degrees Fahrenheit (F)|Percentage of participants with fever defined as oral temperature >=101 degrees F were reported.|Baseline (Day 1) up to Day 8|The intent-to-treat (ITT) population included all participants that were randomized and treated with investigational product.||Percentage of participants|||Number
634520|NCT02742987|Secondary|Number of Patients With Platelet Reactivity >256 P2Y12 Reaction Units||4 weeks||||||
634521|NCT02742987|Secondary|Platelet Reactivity|Platelet reactivity assessed with the VerifyNow P2Y12 Assay|4 weeks||||||
634522|NCT02742987|Secondary|Endothelium-independent Dilation of the Brachial Artery|Percent dilation of the brachial artery, as assessed with vascular ultrasound, from baseline to post-administration of 0.5 mg sublingual nitroglycerin|4 weeks||||||
634523|NCT02742987|Secondary|Number of Patients With Flow-mediated Dilation of the Brachial Artery <7%||4 weeks||||||
634524|NCT02742987|Primary|Flow-mediated Dilation of the Brachial Artery|Percent dilation of the brachial artery, as assessed with vascular ultrasound, from baseline to post-occlusion|4 weeks|||FMD (%)||Standard Deviation|Mean
634525|NCT02739698|Primary|The Grouped Miller and Payne (MP) System for Pathological Response: G1 (Minimal Changes and < 30% Cells Tumour Reduction That Includes MP G1-G2), G3 (Microscopic Foci, Cells Tumour Reduction up to >90% That Includes MP G3-G4) and G5 (no Residual Tumour)|Histopathology scoring system to assess response, previous and post intraperitoneal intraoperative chemotherapy. Compare cancer cellularity of the biopsy (before treatment) with the other biopsy (after treatment).|The biopsies were taken before and after the treatment (intraperitoneal intraoperative chemotherapy for 60 minutes) and then they were analysed by two blinded pathologists.|||percentage of complete pathological resp|||Number
634526|NCT02739594|Secondary|Percent Change From Baseline in CrCl|CrCl was calculated from blood samples using the Cockcroft-Gault formula, and was also measured by urinalysis. The percent change in CrCl was calculated as [Week 44 or 92 CrCl minus Baseline CrCl] divided by Baseline CrCl, multiplied by 100. For the Week 44 analysis, the last available value on/before Week 44 was used in the calculation. For the Week 92 analysis, the last available value on/before Week 92 was used in the calculation.|Baseline and Weeks 44, 92|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who provided data within the specified timeframe for each analysis (n) is shown in the table."||percent change||Standard Deviation|Mean
634527|NCT02739594|Secondary|Percentage of Participants With Elevation of Serum Creatinine (SCr) From Baseline|Elevation in SCr was defined as an increase greater than (>) 0.5 milligrams per deciliter (mg/dL) for participants with Baseline SCr less than (<) 1.4 mg/dL, or an increase >1.0 mg/dL for participants with Baseline SCr greater than or equal to (≥) 1.4 mg/dL. For the Week 44 analysis, the last available value on/before Week 44 was used. For the Week 92 analysis, the last available value on/before Week 92 was used. The percentage of participants with elevation of SCr at Weeks 44 and 92 was reported.|Baseline and Weeks 44, 92|ITT Population.||percentage of participants||95% Confidence Interval|Number
634528|NCT02739594|Secondary|Percent Change From Baseline in Gamma-Glutamyltransferase (GGT)|The percent change in GGT was calculated as [Week 44 or 92 GGT minus Baseline GGT] divided by Baseline GGT, multiplied by 100. For the Week 44 analysis, the last available value on/before Week 44 was used in the calculation. For the Week 92 analysis, the last available value on/before Week 92 was used in the calculation.|Baseline and Weeks 44, 92|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||percent change||Full Range|Median
634529|NCT02739594|Secondary|Percent Change From Baseline in Alpha (A) 1-Microglobulin|The percent change in A1-microglobulin was calculated as [Week 44 or 92 A1-microglobulin minus Baseline A1-microglobulin] divided by Baseline A1-microglobulin, multiplied by 100. For the Week 44 analysis, the last available value on/before Week 44 was used in the calculation. For the Week 92 analysis, the last available value on/before Week 92 was used in the calculation.|Baseline and Weeks 44, 92|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||percent change||Full Range|Median
639125|NCT02406937|Secondary|Fecal Concentration of Short Chain Fatty Acid|fecal concentration of acetate, propionate and butyrate acid|Baseline, Day 21|||mg/g||Standard Deviation|Mean
634530|NCT02739594|Secondary|Percent Change From Baseline in N-Acetyl-Beta-D-Glucosaminidase (B-NAG)|The percent change in B-NAG was calculated as [Week 44 or 92 B-NAG minus Baseline B-NAG] divided by Baseline B-NAG, multiplied by 100. For the Week 44 analysis, the last available value on/before Week 44 was used in the calculation. For the Week 92 analysis, the last available value on/before Week 92 was used in the calculation.|Baseline and Weeks 44, 92|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||percent change||Full Range|Median
634531|NCT02739594|Secondary|Number of Zoledronate Dose Reductions for Each Participant|The number of zoledronate dose reductions was averaged across all participants, including those participants who did not have any dose reductions during the study.|From Baseline to end of study (up to Week 96)|ITT Population; only the Zoledronate arm was included.||dose reductions||Standard Deviation|Mean
634532|NCT02739594|Secondary|Percentage of Participants With Zoledronate Dose Reduction|The percentage of participants with at least 1 zoledronate dose reduction during the study was reported.|From Baseline to end of study (up to Week 96)|ITT Population; only the Zoledronate arm was included.||percentage of participants||95% Confidence Interval|Number
634533|NCT02739594|Secondary|Number of Events of Osteonecrosis of Jaw for Each Participant|The number of events of osteonecrosis of jaw was averaged across all participants, including those participants who did not experience the event during the study.|From Baseline to end of study (up to Week 96)|ITT Population.||events of osteonecrosis of jaw||Standard Deviation|Mean
634534|NCT02739594|Secondary|Percentage of Participants With Osteonecrosis of Jaw|The percentage of participants with at least 1 event of osteonecrosis of jaw during the study was reported.|From Baseline to end of study (up to Week 96)|ITT Population.||percentage of participants||95% Confidence Interval|Number
634535|NCT02739594|Secondary|Number of SREs for Each Participant|SREs were defined according to the Bondronat SmPC to include radiotherapy to bone for treatment of fractures/impending fractures, surgery to bone for treatment of fractures, vertebral fractures, and non-vertebral fractures. The number of SREs was averaged across all participants, including those participants who did not experience SREs during the study.|From Baseline to end of study (up to Week 96)|ITT Population.||SREs||Standard Deviation|Mean
634536|NCT02739594|Secondary|Time to First SRE|SREs were defined according to the Bondronat SmPC to include radiotherapy to bone for treatment of fractures/impending fractures, surgery to bone for treatment of fractures, vertebral fractures, and non-vertebral fractures. Time to first SRE was defined as the time from first dose of study drug to the time of SRE during the study. The median time to first SRE was estimated by Kaplan-Meier analysis and expressed in days.|From Baseline to end of study (up to Week 96)|ITT Population.||days||Full Range|Median
634537|NCT02739594|Secondary|Percentage of Participants With Skeletal-Related Events (SREs)|SREs were defined according to the Bondronat Summary of Product Characteristics (SmPC) to include radiotherapy to bone for treatment of fractures/impending fractures, surgery to bone for treatment of fractures, vertebral fractures, and non-vertebral fractures. The percentage of participants with at least 1 SRE during the study was reported.|From Baseline to end of study (up to Week 96)|ITT Population.||percentage of participants||95% Confidence Interval|Number
634538|NCT02739594|Primary|Percentage of Participants With Deterioration in Renal Function According to Reduction in CrCl From Baseline to Week 92|CrCl was calculated from blood samples using the Cockcroft-Gault formula. Relevant deterioration in renal function was defined as CrCl reduction of 30% from Baseline or an absolute value ≤30 mL/min at Week 92. The last available value on/before Week 92 was used in the calculation. The percentage of participants with deterioration in renal function at Week 92 was reported.|Baseline, Week 92|ITT Population.||percentage of participants||95% Confidence Interval|Number
634539|NCT02739594|Primary|Percentage of Participants With Deterioration in Renal Function According to Reduction in Creatinine Clearance (CrCl) From Baseline to Week 44|CrCl was calculated from blood samples using the Cockcroft-Gault formula. Relevant deterioration in renal function was defined as CrCl reduction of 30 percent (%) from Baseline or an absolute value less than or equal to (≤) 30 milliliters per minute (mL/min) at Week 44. The last available value on/before Week 44 was used in the calculation. The percentage of participants with deterioration in renal function at Week 44 was reported.|Baseline, Week 44|Intent-to-Treat (ITT) Population.||percentage of participants||95% Confidence Interval|Number
634540|NCT02737852|Primary|Number of Subjects With Observed Edema Based on the 5 Point Scoring Scale|Number of subjects with observed local edema by obstetrician/gynecologist examination as graded on 5 point clinical scale: 0 = normal appearance no edema, 0.5 = slight edema, 1 = mild edema, 2 = moderate edema 3 = severe edema|2 weeks|||Participants|||Count of Participants
634541|NCT02737852|Primary|Number of Subjects With Observed Local Erythema Based on the 5 Point Scoring Scale|Number of subjects with observed local erythema by obstetrician/gynecologist examination as graded on 5 point clinical scale: 0 = normal appearance no irritation, 0.5 = slight, irregular erythema, 1 = mild erythema, 2 = moderate erythema 3 = severe erythema|2 weeks|||Participants|||Count of Participants
634542|NCT02737631|Primary|Number of Patients That Showed Edema Based on the 5 Point Scoring Scale||8 weeks|||Participants|||Count of Participants
634543|NCT02737631|Primary|Number of Patients That Showed Erythema Based on the 5 Point Scoring Scale||8 weeks|||Participants|||Count of Participants
634544|NCT02737618|Primary|Number of Subjects That Showed Edema Based on the 5 Point Scoring Scale||14 days|||Participants|||Count of Participants
634545|NCT02737618|Primary|Number of Subjects That Showed Erythema Based on 5 Point Scoring Scale||14 days|||Participants|||Count of Participants
634546|NCT02737592|Primary|Number of Subjects With Observed Edema Based on the 5 Point Scoring Scale|Number of subjects with observed local edema by OB/GYN examination as graded on 5 point clinical scale: 0 = normal appearance no edema, 0.5 = slight edema, 1 = mild edema, 2 = moderate edema 3 = severe edema|2 weeks|||Participants|||Count of Participants
634547|NCT02737592|Primary|Number of Subjects With Observed Local Erythema Based on 5 Point Scale|Number of subjects with observed local erythema by OB/GYN examination as graded on 5 point clinical scale: 0 = normal appearance no irritation, 0.5 = slight, irregular erythema, 1 = mild erythema, 2 = moderate erythema 3 = severe erythema|2 weeks|||Participants|||Count of Participants
634548|NCT02736721|Primary|Time to Loss of Previous MR|Time to loss of previous MR was defined as the interval between the first day of treatment in the study and the first day of loss of previous MR. MR was assessed using BCR-ABL transcript levels measured by RT-PCR from peripheral blood.|Up to approximately 7 years|Analysis population included all enrolled participants.||years||95% Confidence Interval|Median
634550|NCT02736721|Primary|Time to Loss of Previous CyR|Time to loss of previous CyR was defined as the interval between the first day of treatment in the study and the first day of loss of previous CyR. CyR is based on the prevalence of Ph+ bone marrow cells in metaphase. Major CyR was categorized as either CCyR or PCyR. CCyR was achieved when there was absence of detectable Ph+ bone marrow cells and PCyR was achieved when 1 to 34% of bone marrow cells were Ph+.|Up to approximately 7 years|Analysis population included all enrolled participants.||years||95% Confidence Interval|Median
634551|NCT02736721|Primary|Number of Participants With Major Cytogenetic Response (CyR)|CyR was based on the prevalence of Philadelphia chromosome-positive (Ph+) bone marrow cells in metaphase determined from reverse transcriptase polymerase chain reaction (RT-PCR). Major cytogenetic response was categorized as either complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). CCyR was achieved when there was absence of detectable Ph+ bone marrow cells and PCyR was achieved when 1 to 34 percent (%) of bone marrow cells were Ph+.|Up to approximately 7 years|Analysis population included all enrolled participants.||participants|||Number
634552|NCT02736721|Primary|Time to Loss of Previous Hematologic Response|Time to loss of previous hematologic response was defined as the interval between the first day of treatment in the study and the first day of loss of previous hematologic response during elapsed time of study. Hematologic response was considered to be achieved if participants met all of the following criteria: normalization of white blood cells count to <10*10^9/L with normal differentiation, normalization of platelet count at <450*10^9/L, and disappearance of all signs and symptoms of the disease. This response had to be confirmed at least 4 weeks after the first measure and beyond that.|Up to approximately 7 years|Analysis population included all enrolled participants.||months||95% Confidence Interval|Median
634553|NCT02736721|Primary|Number of Participants With Complete Hematologic Response|Hematologic response was considered to be achieved if participants met all of the following criteria: normalization of white blood cells count to less than (<) 10*10^9 per liter (/L) with normal differentiation, normalization of platelet count at <450*10^9/L, and disappearance of all signs and symptoms of the disease. This response had to be confirmed at least 4 weeks after the first measure and beyond that.|Up to approximately 7 years|Analysis population included all enrolled participants.||participants|||Number
634554|NCT02735200|Primary|Level of Serum 25 OHD Level Pre-treatment and Post Treatment|Patients had analysis of serum 25 OHD level pre and post treatment, to check if treatment with Topical Vitamin D made any difference.|baseline and 5 months|||ng/mL||Standard Deviation|Mean
634555|NCT02734355|Secondary|Exercise Tolerance|six-minute walk distance in meters|7 days|||m||Standard Deviation|Mean
634556|NCT02734355|Secondary|Quality of Life|The average of eight scores of 36-Item Short Form Health Survey (SF-36). In every case all of eight scores (which ranges from 0 to 100) was summarized, then the sum was divided by 8. Thus the outcome also ranges from 0 (worse outcome) to 100 (better outcome).|7 days|||units on a scale||Standard Deviation|Mean
634557|NCT02734355|Primary|Pulmonary Circulation Pressure Load|Right ventricular systolic pressure (RVSP, mm Hg).|7 days|||mm Hg||Standard Deviation|Mean
634558|NCT02734355|Primary|Left Atrial Pressure Load|Mean left atrial pressure (MLAP, mm Hg).|7 days|||mm Hg||Standard Deviation|Mean
634559|NCT02734355|Primary|Left Atrial Dimensions|Left atrial antero-posterior diameter (LAD, cm)|7 days|||cm||Standard Deviation|Mean
634560|NCT02734355|Primary|Left Atrial Contractility|Left atrial active emptying fraction (LAAEF, %)|7 days|||percentage of LA maximum volume||Standard Deviation|Mean
634561|NCT02734355|Primary|Retrograde Flow in Pulmonary Veins|Velocity time integral of right superior pulmonary vein flow during left atrial systole (VTI Ar, cm)|7 days|||cm||Standard Deviation|Mean
634562|NCT02734355|Primary|Pulmonary Vein Flow Emptying|S/D ratio of right superior pulmonary vein flow|7 days|||ratio||Standard Deviation|Mean
634563|NCT02734355|Primary|Isovolumic Relaxation|Left ventricular isovolumic relaxation time (IVRT, ms).|7 days|||ms||Standard Deviation|Mean
634564|NCT02734355|Primary|Diastolic Function|E/A ratio of transmitral flow|7 days|||ratio||Standard Deviation|Mean
634565|NCT02734355|Primary|Left Atrial Reservoir Function|Velocity time integral of transmitral flow (VTITMF, cm) during the whole diastole.|7 days|||cm||Standard Deviation|Mean
634566|NCT02734355|Primary|Active Emptying of Left Atrium|Velocity time integral of transmitral flow during atrial contraction (VTI A, cm).|7 days|||cm||Standard Deviation|Mean
634567|NCT02734355|Primary|Passive Emptying of Left Atrium|Velocity time integral of transmitral flow during left ventricle early filling phase (VTI E, cm).|7 days|||cm||Standard Deviation|Mean
634568|NCT02734212|Secondary|Social Self-Efficacy|The Social Self-Efficacy subscale of Sherer’s Self-Efficacy Scale was used to measure participant’s beliefs or expectations about their abilities with regards to social interactions/relationships. A total score is calculated by summing the responses on the items (range= 5-30). Higher score indicate greater social self-efficacy.|Baseline and Post Treatment (~3 1/2 months)|Number analyzed in the rows differ from overall because 5 participants in the ESS-P and 10 in the eTAU did not complete the post-treatment assessment||units on a scale||Standard Deviation|Mean
634569|NCT02734212|Secondary|General Self-Efficacy|The General Self-Efficacy subscale of Sherer’s Self-Efficacy Scale was used to measure participant’s general beliefs or expectations about their abilities. A total score is calculated by summing the responses on the items (range= 17-85). Higher score indicate greater general self-efficacy.|Baseline and Post Treatment (~3 1/2 months)|Number analyzed in the rows differ from overall because 5 participants in the ESS-P and 10 in the eTAU did not complete the post-treatment assessment||units on a scale||Standard Deviation|Mean
634570|NCT02734212|Primary|Internalized Stigma of Mental Illness Inventory (Internalized Stigma)|The Internalized Stigma of Mental Illness Inventory was used to measure of internalized or self-stigma. A total score is calculated by taking an average of the responses on the items (range=1 to 4). Higher total scores indicate greater internalized stigma.|Basline and Post Treatment (~3 1/2 months)|Number analyzed in the rows differ from overall because 5 participants in the ESS-P and 10 in the eTAU did not complete the post-treatment assessment||units on a scale||Standard Deviation|Mean
634571|NCT02734056|Primary|Anxiety|The questions will be scored and a composite score will be determined. The scale is the numeric rating score, from 0-10, where 0 represents no anxiety and 10 represents the worst anxiety. Unit of measure is score on a scale.|1 hour|||NRS||Standard Deviation|Mean
639448|NCT02393950|Secondary|Sedation Scores on a Visual Analogue Scale (VAS)|Assessment of sedation by subject|Pre-dose and at 1, 6 and 10.5h post dose at each dose level||||||
634572|NCT02732639|Secondary|Percentage of Participants With Positive Hepatitis B Surface Antibody (HBsAb) at Weeks 48 and 72|Samples were collected and analyzed for HBsAb. Positive HBsAb levels are defined as levels above the level of detection of the assay and reflect the presence of antibodies produced against HBsAg.|At Weeks 48 and 72|ITT analysis population included all participants, who received at least one dose of the study medication and had a subsequent post baseline assessment.||percentage of participants||95% Confidence Interval|Number
634573|NCT02732639|Secondary|Percentage of Participants With HBsAg Seronegative at Weeks 48 and 72|Samples were collected and analyzed for HBsAg. Seronegative HBsAg is defined as below the level of detection of the assay.|At Weeks 48 and 72|ITT analysis population included all participants, who received at least one dose of the study medication and had a subsequent post baseline assessment.||percentage of participants||95% Confidence Interval|Number
634574|NCT02732639|Secondary|Number of Participants With Positive Hepatitis B Surface Antigen (HBsAg) Levels|Samples were collected and analyzed for HBsAg. Positive HBsAg levels are defined as levels above the level of detection of the assay.|At Screening and at Weeks 48 and 72|Intention-to-treat (ITT) analysis population included all participants, who received at least one dose of the study medication and had a subsequent post baseline assessment.||participants|||Number
634575|NCT02732639|Secondary|Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Below 1*10^5 Copies/Milliliter (mL) at Weeks 48 and 72|Samples were collected and analyzed for HBV DNA levels. Reported here is the percentage of participants with HBV DNA levels below 1*10^5 copies/mL.|At Weeks 48 and 72|ITT analysis population included all participants, who received at least one dose of the study medication and had a subsequent post baseline assessment.||percentage of participants||95% Confidence Interval|Number
634576|NCT02732639|Secondary|Percentage of Participants With Negative HDV RNA at Week 48|Samples were collected and analyzed for HDV RNA levels. Negative HDV RNA is defined as below the level of detection of the assay.|At Week 48|ITT analysis population included all participants, who received at least one dose of the study medication and had a subsequent post baseline assessment.||percentage of participants||95% Confidence Interval|Number
634577|NCT02732639|Secondary|Percentage of Participants With Normal ALT at Week 48|Samples were collected and analyzed for ALT levels. A normal ALT is a value within the normal range of the assay.|At Week 48|ITT analysis population included all participants, who received at least one dose of the study medication and had a subsequent post baseline assessment.||percentage of participants||95% Confidence Interval|Number
634578|NCT02732639|Primary|Percentage of Participants With Negative Hepatitis D Virus Ribonucleic Acid (HDV RNA) at Week 72|Samples were collected and analyzed for HDV RNA levels. Negative HDV RNA is defined as below the level of detection of the assay.|At Week 72|Intention-to-treat (ITT) analysis population included all participants, who received at least one dose of the study medication and had a subsequent post baseline assessment.||percentage of participants||95% Confidence Interval|Number
634579|NCT02732639|Primary|Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Week 72|Samples were collected and analyzed for ALT. A normal ALT is a value within the normal range of the assay.|At Week 72|Intention-to-treat (ITT) analysis population included all participants, who received at least one dose of the study medication and had a subsequent post baseline assessment.||percentage of participants||95% Confidence Interval|Number
634580|NCT02732561|Primary|Anxiety|Hamilton Anxiety Rating Scale. The Hamilton Anxiety Rating Scale (HAM-A) is a psychological questionnaire used by clinicians to rate the severity of a patient's anxiety (Hamilton, 1959; McDowell, Newell & & McDowell, 2006). The scale consists of 14 items designed to assess the severity of a patient’s anxiety. Each of the 14 items contains a number of symptoms, and each group of symptoms is rated on a scale of zero to four, with four being the most severe (with a total score range of 0–56). All of these scores are used to compute an overarching score that indicates a person’s anxiety severity (Vaccarino, 2008). A score of 17 or less indicates mild anxiety severity. A score from 18 to 24 indicates mild to moderate anxiety severity. Lastly, a score of 25 to 30 indicates a moderate to severe anxiety severity. Higher values represent a worse outcome.|4 weeks|includes only matched pairs||units on a scale||Full Range|Median
634581|NCT02732561|Primary|Depressive Symptoms|Hamilton Depression Rating Scale. The Hamilton Rating Scale for Depression is a multiple item questionnaire used to provide an indication of depression and as a guide to evaluate recovery (Hedlund, 1979). The questionnaire is designed for adults and is used to rate the severity of their depression by probing mood, feelings of guilt, suicide ideation, insomnia, agitation or retardation, anxiety, weight loss, and somatic symptoms. A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression, and are usually required for entry into a clinical trial. Assessment time is estimated at 20 minutes (Hamilton, 1960). Higher values represent a worse outcome. The HAM-D form lists 21 items, the scoring is based on the first 17.Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2, with a total score range of 0–50.|4 weeks|Only includes matched pairs||units on a scale||Full Range|Median
634582|NCT02732327|Primary|Percentage of Patients With Favorable Clinical Response at End of Inpatient Intravenous Therapy (EOIV)|Favorable clinical response is defined as resolution of all acute signs and symptoms of the primary infection or improvement to such an extent that no additional antibacterial therapy is required as assessed by the investigator. Due to study termination and limited enrollment, outcome measures were not analyzed.|Up to Day 14||||||
634583|NCT02732210|Secondary|Percentage of Participants Satisfying Medication-taking Behavior at 24 Months|Percentage of participants satisfying medication-taking behavior defined as the participant received all 4 Prolia® injections and the length of time between any 2 consecutive Prolia® injections did not exceed 6 months with a grace period of ± 4 weeks.|24 months|Full analysis set||percentage of participants||95% Confidence Interval|Number
634584|NCT02732210|Secondary|Percentage of Participants Satisfying Medication-taking Behavior at 12 Months|Percentage of participants satisfying medication-taking behavior defined as, following the first Prolia® injection, the participant received a second Prolia® injection and the length of time between the first and the second Prolia® injection did not exceed 6 months with a grace period of ± 4 weeks.|12 months|Full analysis set||percentage of participants||95% Confidence Interval|Number
634585|NCT02732210|Secondary|Number of Prolia® Injections Received|The number of injections that a participant received over 24 months (including the baseline injection) regardless of when the injection was received.|24 months|Full analysis set||prolia injections||Inter-Quartile Range|Median
634586|NCT02732210|Secondary|Time to Non-persistence|For non-persistent participants, time to non-persistence was calculated as the time between the date of the first injection and the date of last injection received during the period where the participant was still classified as persistent plus 6 months (183 days).|24 months|Full analysis set with non-persistence at 24 months||months||Inter-Quartile Range|Median
634587|NCT02732210|Primary|Percentage of Participants With Persistence With Prolia® at 24 Months|A participant was considered persistent with Prolia® at 24 months if they received at least 4 Prolia® injections and the length of time between any 2 consecutive Prolia® injections does not exceed 6 months plus 8 weeks (239 days).|24 months|Full analysis set||percentage of participants||95% Confidence Interval|Number
634588|NCT02732210|Primary|Percentage of Participants With Persistence With Prolia® at 12 Ponths|A participant was considered persistent with Prolia® at 12 months if they received at least 2 Prolia® injections no more than 6 months plus 8 weeks (239 days) apart.|12 months|Full Analysis Set (all enrolled participants)||percentage of participants||95% Confidence Interval|Number
634589|NCT02731833|Secondary|Change From Baseline in Tactile Threshold Post First Treatment by Direct Application|The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gives two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth.|Baseline to 60 seconds post first treatment|Analysis for this outcome was performed on ITT population, defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment.||g||Standard Deviation|Mean
634590|NCT02731833|Secondary|Change From Baseline in Schiff Sensitivity Score Post First Treatment by Direct Application|The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale which was scored as follows - 0: Participant does not respond to air stimulation; 1: Participant responded to air stimulus but does not request discontinuation of stimulus; 2: Participant responded to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus. A reduction in Schiff Sensitivity score was indicative of an improvement in sensitivity.|Baseline to 60 seconds post first treatment|Analysis for this outcome was performed on ITT population, defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment.||Score on a scale||Standard Deviation|Mean
634591|NCT02731833|Secondary|Change From Baseline in Tactile Threshold on Day 3|The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gives two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth.|Baseline to Day 3|Analysis for this outcome was performed on ITT population, defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment.||g||Standard Deviation|Mean
634592|NCT02731833|Primary|Change From Baseline in Schiff Sensitivity Score on Day 3|The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale which was scored as follows - 0: Participant does not respond to air stimulation; 1: Participant responded to air stimulus but does not request discontinuation of stimulus; 2: Participant responded to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus. A reduction in Schiff Sensitivity score was indicative of an improvement in sensitivity.|Baseline to Day 3|Analysis for this outcome was performed on intent-to-treat (ITT) population, defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment.||Score on a scale||Standard Deviation|Mean
634593|NCT02731313|Secondary|Weighted Kappa Coefficient Between Immunohistochemistry (IHC) 4B5 and Silver in Situ Hybridization (SISH) Techniques for HER-2 Testing in Centralized Laboratories|Positive HER-2 status was defined as either immunohistochemistry (IHC) score of 3+ or IHC score 2+/in situ hybridization (ISH) score +, as per the trastuzumab Summary of Product Characteristics (SPC). The HER-2 status in tumor specimens was determined using IHC 4B5 and silver ISH (SISH) in centralized laboratories. The weighted kappa coefficient was used to evaluate the true concordance between the HER-2 status determined by IHC 4B5 and SISH. The weighted kappa coefficient value was interpreted according to the Landis and Koch classification as follows: a) less than (<) 0: less than chance agreement, b) 0.01-0.20: slight agreement, c) 0.21-0.40: fair agreement, d) 0.41-0.60: moderate agreement, e) 0.61-0.80: substantial agreement, and f) 0.81-0.99: almost perfect agreement.|At enrollment|The specimens' population is defined as all specimens for which at least one IHC and/or ISH test was done in the centralized laboratory, without any reasons for exclusion. Here, ‘n’ is number of specimens with available data for this outcome measure.||weighted kappa coefficient|Participants|95% Confidence Interval|Number
634626|NCT02721641|Primary|Number of Participants Withdrawn From Study Because of LVEF Dysfunction|LVEF dysfunction was defined as low LVEF measured on two consecutive assessments, with the second assessment performed after 3 weeks of study medication being withheld. Low LVEF included values less than or equal to 39% or values between 40% and 45% (inclusive) with a decrease of 10 or more percentage points from Baseline.|From date of enrollment until death or premature withdrawal (maximum 7.4 years of follow-up)|All enrolled participants with available LVEF data were included in the analysis.||Participants|||Count of Participants
638748|NCT02429258|Primary|Change in 24-hour Mean Weighted Glucose (MWG) From Baseline to End of Treatment (Week 4) Using the Continuous Glucose Monitoring (CGM) System||Baseline to Week 4|||mg/dL||Standard Error|Least Squares Mean
634594|NCT02731313|Secondary|Cancer Characteristics: Percentage of Participants With Samples in Each of the Tumor-Node-Metastasis (TNM) Stages|The TNM stage system includes information about the size of the primary tumor (T), whether the cancer has spread to nearby lymph nodes (N) and whether the cancer has metastasized to other parts of the body (M). In the T classification TX indicates that the main tumor cannot be measured, T1, T2, T3 and T4 refer to the size and/or extent of the main tumor. The higher the number after the T, the larger the tumor or the more it has grown into nearby tissues. In the N classification NX indicates that the cancer in nearby lymph nodes cannot be measured, N0 indicates that there is no cancer in nearby lymph nodes, N1, N2 and N3 refer to the number and location of lymph nodes that contain cancer. The higher the number after the N, the more lymph nodes that contain cancer. In the M classification MX indicates that the metastasis cannot be measured, M0 indicates that the cancer has not spread to other parts of the body and M1 indicates that the cancer has spread to other parts of the body.|At enrollment|The participants’ sub-population being all participants from the specimen population, which is defined as all specimens for which at least one IHC and/or ISH test was done in the centralized laboratory, without any reasons for exclusion. Here, ‘n’ is number of participants with available data for this outcome measure.||percentage of participants|||Number
634595|NCT02731313|Secondary|Cancer Characteristics: Percentage of Participants With Samples in Each of the Histologic Type Lauren's Classifications, Including Diffuse Type, Intestinal and Mixed|The Lauren classification is based on examination of histologic specimens under the microscope and divides adenocarcinoma of the stomach into 3 types: 1) Diffuse type: tumor cells are poorly differentiated, behave aggressively and tend to scatter throughout the stomach (rather than form glands). This type metastasizes to other parts of the body much quicker than intestinal type tumors, 2) Intestinal type: tumor cells are well differentiated, grow slowly and tend to form glands, 3) Mixed type: this type is made up of both intestinal and diffuse types.|At enrollment|The participants’ sub-population being all participants from the specimen population, which is defined as all specimens for which at least one IHC and/or ISH test was done in the centralized laboratory, without any reasons for exclusion. Here, ‘n’ is number of participants with available data for this outcome measure.||percentage of participants|||Number
634596|NCT02731313|Secondary|Cancer Characteristics: Percentage of Participants With Initial Location of Adenocarcinoma in Stomach Versus Esogastric Location||At enrollment|The participants’ sub-population being all participants from the specimen population, which is defined as all specimens for which at least one IHC and/or ISH test was done in the centralized laboratory, without any reasons for exclusion. Here, ‘n’ is number of participants with available data for this outcome measure.||percentage of participants|||Number
634597|NCT02731313|Primary|Simple Kappa Coefficient of Human Epidermal Growth Factor Receptor 2 (HER-2) Status Between Local and Centralized Laboratory Assessments|Positive HER-2 status was defined as either immunohistochemistry (IHC) score of 3+ or IHC score 2+/in situ hybridization (ISH) score +, as per the trastuzumab Summary of Product Characteristics (SPC). The HER-2 status in tumor specimens was determined using the pathologist’s choice of IHC and ISH techniques in local laboratories, and using IHC 4B5 and silver ISH (SISH) in centralized laboratories. The kappa coefficient was used to evaluate the true concordance between the HER-2 status determined by local and centralized laboratories. The kappa coefficient value was interpreted according to the Landis and Koch classification as follows: a) less than (<) 0: less than chance agreement, b) 0.01-0.20: slight agreement, c) 0.21-0.40: fair agreement, d) 0.41-0.60: moderate agreement, e) 0.61-0.80: substantial agreement, and f) 0.81-0.99: almost perfect agreement.|At enrollment|The specimens’ population is defined as all specimens for which at least one IHC and/or ISH test was done in the centralized laboratory, without any reasons for exclusion.||kappa coefficient|Participants|95% Confidence Interval|Number
634598|NCT02731300|Secondary|Number of Epileptic Discharge After Treatment by tDCS||Baseline, 4 Weeks|||epileptic discharges/30 mins||Standard Deviation|Mean
634599|NCT02731300|Primary|Number of Seizure After Treatment by tDCS||Baseline, 4 Weeks|||seizures||Standard Deviation|Mean
634600|NCT02731131|Secondary|Number of Participants With Negative HDV RNA at End of Treatment|Negative HDV RNA was defined as HDV RNA not detected by PCR. The number of participants with negative HDV RNA at the end of treatment (Week 48) was reported.|Week 48|ITT Population.||participants|||Number
634601|NCT02731131|Secondary|Number of Participants With Negative HDV RNA at 48 Weeks After End of Treatment|Negative HDV RNA was defined as HDV RNA not detected by PCR. The number of participants with negative HDV RNA at 48 weeks after end of treatment (Week 96) was reported.|Week 96|ITT Population.||participants|||Number
634602|NCT02731131|Secondary|Number of Participants With ALT Normalization at End of Treatment|Normalized ALT was defined as ALT value above the ULN at Baseline with a decrease in ALT value to at/below the ULN at the end of treatment (Week 48). The number of participants with ALT normalization at Week 48 was reported.|Week 48|ITT Population.||participants|||Number
634603|NCT02731131|Secondary|Number of Participants With ALT Normalization at 48 Weeks After End of Treatment|Normalized ALT was defined as ALT value above the ULN at Baseline with a decrease in ALT value to at/below the ULN at 48 weeks after end of treatment (Week 96). The number of participants with ALT normalization at Week 96 was reported.|Week 96|ITT Population.||participants|||Number
634604|NCT02731131|Secondary|Number of Participants With ALT Normalization Plus Negative HDV RNA at End of Treatment|Normalized ALT was defined as ALT value above the ULN at Baseline with a decrease in ALT value to at/below the ULN at the end of treatment (Week 48). Negative HDV RNA was defined as HDV RNA not detected by PCR. The number of participants with ALT normalization and negative HDV RNA at Week 48 was reported.|Week 48|ITT Population.||participants|||Number
634605|NCT02731131|Primary|Number of Participants With Alanine Aminotransferase (ALT) Normalization Plus Negative Hepatitis D Virus (HDV) Ribonucleic Acid (RNA) at 48 Weeks After End of Treatment|Normalized ALT was defined as ALT value above the upper limit of normal (ULN) at Baseline with a decrease in ALT value to at/below the ULN at 48 weeks after end of treatment (Week 96). Negative HDV RNA was defined as HDV RNA not detected by polymerase chain reaction (PCR). The number of participants with ALT normalization and negative HDV RNA at Week 96 was reported.|Week 96|ITT Population.||participants|||Number
634609|NCT02730260|Primary|Smoking Abstinence for 7 Days at Last Contact|By self report, the participant has smoked no cigarettes in the past 7 days on the date of last post-intervention assessment, which occurs 6 to 12 months after enrollment.|6-12 months|These are participants who were successfully contacted at 6 or 12 months following enrollment. Other participants are counted as continuing smokers.||participants|||Number
634610|NCT02726971|Secondary|Participants With Improvement of Menstrual Pattern at Third-look Hysteroscopy|The menstrual pattern is clarified as four types which includes amenorrhea, scant spotting, light period, normal period. The menstrual pattern of every participant was recored and compared with herself (before and 3 months after surgery). The number showed below is patients whose menstrual pattern had improved after surgery and estrogen therapy.|3 months after surgery|||participants|||Number
634611|NCT02726971|Secondary|the AFS Score at Third-look Hysteroscopy|The AFS score is based on the American Fertility Society (AFS) Classification of Intra-uterine adhesions( 1988 version)The total range of AFS score is from 0 to 12, and the higher the score is, the worse the outcome is.|2 months after surgery|||units on a scale||Standard Deviation|Mean
634612|NCT02726971|Primary|the AFS Score at Second-look Hysteroscopy|The AFS score is based on the American Fertility Society (AFS) Classification of Intra-uterine adhesions( 1988 version)The total range of AFS score is from 0 to 12, and the higher the score is, the worse the outcome is.|1 months after the surgery|||units on a scale||Standard Deviation|Median
634613|NCT02726178|Secondary|The Modifications in HRV (the Mean Cardiac Cycle Length, the Square Root of the Mean Squared Differences of Successive RR Intervals and the Magnitude of Global HRV),That Can Predict the Occurrence of CRE in Preterm Infants After Immunization.|The secondary objective was to identify predictive factors of occurrence of CRE in preterm infants after immunization through the analysis of their HRV; the mean cardiac cycle length, the square root of the mean squared differences of successive RR intervals and the magnitude of global HRV. Two annotated polysomnographies were performed for all patients with an AURA PSG GRASS ambulatory and wireless system. Each polysomnography had a duration of 2.5 hours: the first was conducted on enrolment (the day before immunization), and the second was conducted 18 to 24 hours after immunization : we compared the data of polysomnographies after to those before immunization.|polysomnographies data 18 to 24 hours after minus baseline plysomnographies (24 hours before immunization)||07/2017||||
634614|NCT02726178|Primary|The Change in the Number of CRE (Extracted From Printed Monitoring Tracings Compared to Noted Nurses’ Surveillance) Following the First Dose of Pentavalent Vaccine in Preterm Infants Born < 32 Weeks Gestation After Administration of Ibuprofen.|Immunization with the pentavalent vaccine Diphtheria-Tetanus-Acellular pertussis-Inactivated poliomyelitis-Haemophilus influenzae type b (DTPa-IPV-Hib) at two months of age is known to be associated with cardio-respiratory events (CRE), in 11 to 47% of preterm infants.It is considered that the immature brainstem respiratory control of preterms make them more vulnerable to the inflammatory reaction caused by immunization. We hypothesized that post-immunization CRE are correlated with inflammatory reaction. The primary objective was to examine the impact of endogenous PG inhibition on the occurrence of CRE following the first dose of pentavalent vaccine in preterm infants born < 32 weeks gestation. Total CRE was expressed as the average number of events (desaturation + apneas + bradycardia) / 24 hours. Δ Total CRE / patient / 24 hours was defined as the difference between the average number of events / 24 hours observed before vs. after immunization for each patient.|the mean of CRE occured in the 48h after immunization minus the base line CRE : mesured 24h before immunization|||events/patient/24hours||Standard Deviation|Mean
634615|NCT02726022|Primary|Change From Baseline in SF-36 MCS at 24 Weeks After EOT|SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from mental health, role emotional, social functioning, and vitality domains were averaged to calculate MCS. Total score range for MCS was 0-100 (100=highest level of mental functioning).|Baseline, 24 weeks after EOT (up to 72 weeks)|Analysis population included all enrolled participants. Number of participants analyzed = participants with evaluable data. Participants evaluable for Gender = 56; participants evaluable for Drug Addiction = 56. Same participants could be evaluated under Gender and Drug Addiction.||units on a scale||Standard Deviation|Mean
634616|NCT02726022|Primary|Change From Baseline in SF-36 Mental Component Summary (MCS) at EOT|SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from mental health, role emotional, social functioning, and vitality domains were averaged to calculate MCS. Total score range for MCS was 0-100 (100=highest level of mental functioning).|Baseline, EOT (up to 48 weeks)|Analysis population included all enrolled participants. Number of participants analyzed = participants with evaluable data. Participants evaluable for Gender = 76; participants evaluable for Drug Addiction = 75. Same participants could be evaluated under Gender and Drug Addiction.||units on a scale||Standard Deviation|Mean
634627|NCT02721641|Primary|Number of Participants With Drop in Left Ventricular Ejection Fraction (LVEF) Below 45 Percent (%)||From date of enrollment until disease progression, death, or premature withdrawal; assessed per investigator discretion (maximum 7.4 years of follow-up)|All enrolled participants with available LVEF data were included in the analysis.||Participants|||Count of Participants
634617|NCT02726022|Primary|Change From Baseline in SF-36 PCS at 24 Weeks After EOT|SF-36 is a standardized survey evaluating 8 aspects of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from physical function, role physical, bodily pain, and general health domains were averaged to calculate PCS. Total score range for PCS was 0-100 (100=highest level of physical functioning).|Baseline, 24 weeks after EOT (up to 72 weeks)|Analysis population included all enrolled participants. Number of participants analyzed = participants with evaluable data. Participants evaluable for Gender = 56; participants evaluable for Drug Addiction = 56. Same participants could be evaluated under Gender and Drug Addiction.||units on a scale||Standard Deviation|Mean
634618|NCT02726022|Primary|Change From Baseline in SF-36 Physical Component Summary (PCS) at EOT|SF-36 is a standardized survey evaluating 8 aspects of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from physical function, role physical, bodily pain, and general health domains were averaged to calculate PCS. Total score range for PCS was 0-100 (100=highest level of physical functioning).|Baseline, EOT (up to 48 weeks)|Analysis population included all enrolled participants. Number of participants analyzed = participants with evaluable data. Participants evaluable for Gender = 76; participants evaluable for Drug Addiction = 75. Same participants could be evaluated under Gender and Drug Addiction.||units on a scale||Standard Deviation|Mean
634619|NCT02726022|Primary|Change From Baseline in SF-36 General Health Domain at 24 Weeks After EOT|SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for general health domain was an average of the individual question scores of this domain, which are scaled 0-100 (100=highest level of functioning). Data was reported by status of gender (male and female) and drug addiction (yes and no).|Baseline, 24 weeks after EOT (up to 72 weeks)|Analysis population included all enrolled participants. Number of participants analyzed = participants with evaluable data. Participants evaluable for Gender = 56; participants evaluable for Drug Addiction = 56. Same participants could be evaluated under Gender and Drug Addiction.||units on a scale||Standard Deviation|Mean
634620|NCT02726022|Primary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Domain at End of Treatment (EOT)|SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for general health domain was an average of the individual question scores of this domain, which are scaled 0-100 (100=highest level of functioning). Data was reported by status of gender (male and female) and drug addiction (yes and no).|Baseline, EOT (up to 48 weeks)|Analysis population included all enrolled participants. Number of participants analyzed = participants with evaluable data. Participants evaluable for Gender = 76; participants evaluable for Drug Addiction = 75. Same participants could be evaluated under Gender and Drug Addiction.||units on a scale||Standard Deviation|Mean
634621|NCT02725788|Primary|Dressing Wear Time|Dressing wear time is the time from dressing application to removal, i.e. catheter no longer needed or catheter-related complication occurs (remove dressing and catheter) OR excessive dressing lift requiring dressing replacement.|Dressing wear time was assessed daily and 8 month dressing wear data are presented|All subjects randomized except three subjects who either failed to have a study dressing applied or whom could not have the primary endpoint ascertained.||Days||Full Range|Median
634622|NCT02724449|Primary|Number of Participants With Change in Incontinence Associated Dermatitis Score|"Patients who were experiencing Incontinence Associated Dermatitis (IAD) from exposure to urine, stool or a combination of both urine & stool received an application of the barrier film every 72 hours. A skin assessment tool designed for IAD was used to document each patient's IAD score over time. The area scored was divided into 6 zones, l & r buttocks, L & right thighs, perianal & gluteal cleft. The % area within each zone with denudement was X by 9, redness was X by 3 and healthy skin X 1. The total score range of the 6 zones was 0-3654 with 3654 being worst case scenario.
Improvement of IAD Score - At baseline (enrollment) the six zones were evaluated for % of denudement, redness, pink and healthy skin assessed. At the end of subject's participation, assessment were completed again to determine final score & change for improvement was measured by reduction in IAD score No improvement of IAD score - No change in score Progression of IAD score - Increase in IAD score"|Baseline and end of treatment (up to 3 weeks)|||participants|||Number
634623|NCT02723188|Secondary|Self-reported Fear Rankings|"Participants marked how fearful they are of stimuli used in the task on a single 10-point scale (1=not afraid, 10=extremely afraid). Higher scores therefore reflect greater fear and are worse in the context of treatment for anxiety disorders.
Scores were collected in response to presentation of the CS+ (the stimulus conditioned to be associated with an aversive outcome) and the CS- (the stimulus not conditioned to be associated with any outcome)."|During three-day experimental task|||units on a scale||Standard Deviation|Mean
634624|NCT02723188|Primary|Galvanic Skin Response (GSR)|"GSR was measured throughout the task using 2 standard electrodes on the fingers. Measurement units were in micro-Siemens; scores were square-root-transformed (a common method in GSR studies). A higher level of GSR in response to stimuli is taken to reflect greater physiological fear response, and thus worse in the context of the relevance of the study conditions to the treatment of anxiety disorders.
Scores were collected in response to presentation of the CS+ (the stimulus conditioned to be associated with an aversive outcome) and the CS- (the stimulus not conditioned to be associated with any outcome)."|During three-day experimental task|||micro-Siemens||Standard Deviation|Mean
634625|NCT02722564|Primary|Change in Breath Alcohol Content Between the Estimated Level and the Actual Level as Measured by an Alco Sensor IV Device|The change was measured both when participants' breath alcohol content was ascending to 0.1 and descending to 0.08.|1 day|The number analyzed for ascending BrAC readings and descending BrAC readings||percent blood alcohol content|BrAC readings|Standard Deviation|Median
634628|NCT02721641|Primary|On-Study Duration of Trial Treatment||From date of enrollment until death or premature withdrawal (maximum 7.4 years of follow-up)|Analysis was performed on all enrolled participants.||days||Full Range|Median
639652|NCT02387554|Secondary|AUCinf|AUCinf(Area under the curve to infinity)|0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr||||||
634631|NCT02721277|Other Pre-specified|Number of Blood Infections|A review of the subject's medical record will determine the presence of bacterial, viral, or fungi colony-forming units (CFU) in the blood.|6 months|Study was terminated due to insufficient enrollment|||||
634632|NCT02721277|Other Pre-specified|Number of Days With Central Venous Catheter||6 months|Study was terminated due to insufficient enrollment|||||
634633|NCT02721277|Other Pre-specified|Number of Days on Oxygen Via Nasal Cannula|Length of therapy with nasal cannula|6 months|Study was terminated due to insufficient enrollment|||||
634634|NCT02721277|Other Pre-specified|Number of Days on Oxygen Via Continuous Positive Airway Pressure|Length of therapy with nasal continuous positive airway pressure|6 months|Study was terminated due to insufficient enrollment|||||
634635|NCT02721277|Other Pre-specified|Number of Days on Mechanical Ventilation Via Endotracheal Tube|Length of therapy with mechanical ventilation|6 months|Study was terminated due to insufficient enrollment|||||
634636|NCT02721277|Secondary|Triglyceride|Laboratory value that evaluates liver function and metabolism of fat|6 months|Study was terminated due to insufficient enrollment|||||
634637|NCT02721277|Secondary|Alkaline Phosphatase|Laboratory value that evaluates liver function|6 months|Study was terminated due to insufficient enrollment|||||
634638|NCT02721277|Secondary|Serum Glucose|Laboratory values that evaluates glucose in the blood|6 months|Study was terminated due to insufficient enrollment|||||
634639|NCT02721277|Secondary|Total Bilirubin|Laboratory value that evaluates liver function|6 months|Study was terminated due to insufficient enrollment|||||
634640|NCT02721277|Secondary|Alanine Aminotransferase|Laboratory value that evaluates liver function|6 months|Study was terminated due to insufficient enrollment|||||
634641|NCT02721277|Secondary|Aspartate Aminotransferase|Laboratory value that evaluates liver function|6 months|Study was terminated due to insufficient enrollment|||||
634642|NCT02721277|Secondary|Albumin|Laboratory value that evaluates liver function|6 months|Study was terminated due to insufficient enrollment|||||
634643|NCT02721277|Secondary|Total Protein|Laboratory value that evaluates liver function|6 months|Study was terminated due to insufficient enrollment|||||
634644|NCT02721277|Secondary|Carbon Dioxide Total|Laboratory value that determines acid-base balance|6 months|Study was terminated due to insufficient enrollment|||||
634645|NCT02721277|Secondary|Number of Participants With Adverse Events Related to Treatment|Laboratory values will be used to determine adverse events.|6 months|Study was terminated due to insufficient enrollment|||||
634646|NCT02721277|Secondary|Number of Subjects Receiving Breast Milk Diet|Enteral administration of breast milk will be noted|6 months|Study was terminated due to insufficient enrollment|||||
634647|NCT02721277|Secondary|Number of Subjects Receiving Formula Diet|Enteral administration of formula will be noted|6 months|Study was terminated due to insufficient enrollment|||||
634648|NCT02721277|Secondary|Length of IV Nutritional Therapy||6 months|Study was terminated due to insufficient enrollment|||||
634649|NCT02721277|Secondary|Number of Concomitant Medications Received||6 months|Study was terminated due to insufficient enrollment|||||
634650|NCT02721277|Secondary|Number of Subjects Requiring Surgery||6 months|Study was terminated due to insufficient enrollment|||||
634651|NCT02721277|Secondary|Measurement of Length for Growth Increase|Growth increase will be measured by length of participants.|6 months|Study was terminated due to insufficient enrollment|||||
634652|NCT02721277|Secondary|Measurement of Weight for Growth Increase|Growth increase will be measured by weight of participants.|6 months|Study was terminated due to insufficient enrollment|||||
634653|NCT02721277|Secondary|Measurement of Head Circumference for Growth Increase|Growth increase will be measured by head circumference of participants.|6 months|Study was terminated due to insufficient enrollment|||||
634654|NCT02721277|Primary|Inflammation of the Liver Between the Groups|Inflammation of the liver will be evaluated by comparing direct bilirubin values between the two groups.|6 months|Study was terminated due to insufficient enrollment|||||
634655|NCT02720952|Secondary|Incidence of Serious Adverse Events (SAEs) and Adverse Events (AE)|"SAEs and AEs reported over the study period.
N.B., Data will not be entered in this section as this is described within the Adverse Events section."|7-10 days||||||
634656|NCT02720952|Secondary|Subject Assessment of Taste of the Product|"Palatability of the investigational product as determined by parent/carer responses to the following questions:
Question 1: My child found swallowing easy. Question 2: My child showed a positive reaction after Infacort was given. Question 3: I would be happy to give my child Infacort in the future. Question 4: Overall, I would prefer Infacort for my child over the usual hydrocortisone medication."|1 minute|||Participants|||Count of Participants
634657|NCT02720952|Secondary|Serum Cortisol Concentration up to 6 Hours|Serum cortisol concentration 240 minutes after intake of study drug as determined by the central laboratory|240 minutes|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
634658|NCT02720952|Primary|Serum Cortisol Concentration up to 240 Minutes|The primary endpoint will be the maximum levels of serum cortisol concentration up to 240 minutes after intake of study drug as determined by the central laboratory.|240 minutes|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
634659|NCT02717754|Secondary|Minimum Plasma Concentration (Cmin) of RO0640802|Collection of the 12-hour post-dose sample took place prior to administration of the second daily dose of drug. RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.|12-hour post dose on Day 1, 5 and predose on Day 2, 3, 4, 5|PK analysis population. Only participants who received oseltamivir were analyzed.||ng/mL||Standard Deviation|Mean
634660|NCT02717754|Secondary|Clearance (CL) of Oseltamivir and RO0640802|CL is a quantitative measure of the rate at which a drug substance is removed from the body. RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.|Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1 and Day 5|PK analysis population. Only participants who received oseltamivir were analyzed.||Liters/hour||Standard Deviation|Mean
634661|NCT02717754|Secondary|Volume of Distribution (Vd) of Oseltamivir and RO0640802|Vd is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.|Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1 and Day 5|PK analysis population. Only participants who received oseltamivir were analyzed.||Liter||Standard Deviation|Mean
634662|NCT02717754|Secondary|Half-Life (t1/2) of Oseltamivir and RO0640802|t1/2 is the time measured for the plasma concentration to decrease by one half. RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.|Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1 and Day 5|PK analysis population. Only participants who received oseltamivir were analyzed.||hour||Standard Deviation|Mean
634663|NCT02717754|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Oseltamivir and RO0640802|Tmax is time of observed maximum plasma concentration. RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.|Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1 and Day 5|PK analysis population. Only participants who received oseltamivir were analyzed.||hour||Standard Deviation|Mean
634664|NCT02717754|Secondary|Cmax of Oseltamivir and RO0640802|Cmax is the maximum observed plasma concentration. RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.|Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1|PK analysis population. Only participants who received oseltamivir were analyzed.||ng/mL||Standard Deviation|Mean
634665|NCT02717754|Secondary|Area Under the Plasma Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUC0-last) of Oseltamivir and RO0640802|AUC is a measure of the plasma concentration of the drug over time. RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.|Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1 and Day 5|PK analysis population. Only participants who received oseltamivir were analyzed.||ng*hour/mL||Standard Deviation|Mean
634666|NCT02717754|Secondary|Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of Oseltamivir and RO0640802|AUC is a measure of the plasma concentration of the drug over time. RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.|Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1|PK analysis population. Only participants who received oseltamivir were analyzed.||ng*hour/mL||Standard Deviation|Mean
634667|NCT02717754|Primary|Maximum Plasma Concentration (Cmax) of Oseltamivir and RO0640802 at Steady State|Cmax is the maximum observed plasma concentration, presented in nanogram per milliliter (ng/mL). RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.|Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 5|PK analysis population. Only participants who received oseltamivir were analyzed.||ng/mL||Standard Deviation|Mean
634668|NCT02717754|Primary|Area Under the Plasma Concentration-Time Curve From Time 0 to 12 Hour (AUC0-12h) of Oseltamivir and RO0640802 at Steady State|AUC is a measure of the plasma concentration of the drug over time. AUC is presented in nanogram times (*) hour per milliliter (ng*hour/mL). RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.|Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 5|Pharmacokinetic (PK) analysis population included all participants who were dosed correctly. Only participants who received oseltamivir were analyzed.||ng*hour/mL||Standard Deviation|Mean
634669|NCT02716779|Secondary|Time to Maximum Concentration (Tmax) of GPT|Tmax was obtained directly from the concentration-time data.|From Day 0 at 0 hour (hr), 12 hr, 24 hr, 36 hr, 48 hr, 60 hr and 72 hr, Day 42 at 0 hr, 12 hr, 24 hr and 36 hr and at each visit up to Day 126.|All evaluable participants of the ITT population, who were documented for a total of 126 days of the treatment period.||days||95% Confidence Interval|Median
634670|NCT02716779|Secondary|Maximum Concentration (Cmax) of GPT|Cmax was obtained directly from the concentration-time data.|From Day 0 at 0 hour (hr), 12 hr, 24 hr, 36 hr, 48 hr, 60 hr and 72 hr, Day 42 at 0 hr, 12 hr, 24 hr and 36 hr and at each visit up to Day 126.|All evaluable participants of the ITT population, who were documented for a total of 126 days of the treatment period.||U/L||95% Confidence Interval|Median
634671|NCT02716779|Secondary|Area Under the Concentration-Time Curve (AUC) of Glutamate-Pyruvate Transaminase (GPT)||From Day 0 at 0 hour (hr), 12 hr, 24 hr, 36 hr, 48 hr, 60 hr and 72 hr, Day 42 at 0 hr, 12 hr, 24 hr and 36 hr and at each visit up to Day 126.|All evaluable participants of the ITT population, who were documented for a total of 126 days of the treatment period.||(Units/liter)*day ([U/L]*d)||95% Confidence Interval|Median
634672|NCT02716779|Secondary|Time to Maximum Concentration (Tmax) of PEG-IFN|Tmax was obtained directly from the concentration-time data. Evaluation of PEG-IFN arm after day 0. Evaluation of ribavirin and placebo arms after day 42.|From Day 0 at 0 hour (hr), 24 hr, 48 hr and 72 hr, Day 42 at 0 hr and 24 hr and at approximately every other visit up to Day 126|All evaluable participants of the ITT population, who were documented for a total of 126 days of the treatment period.||weeks||95% Confidence Interval|Median
634673|NCT02716779|Secondary|Maximum Concentration (Cmax) of PEG-IFN|Cmax was obtained directly from the concentration-time data. Evaluation of PEG-IFN arm after day 0. Evaluation of ribavirin and placebo arms after day 42.|From Day 0 at 0 hour (hr), 24 hr, 48 hr and 72 hr, Day 42 at 0 hr and 24 hr and at approximately every other visit up to Day 126|All evaluable participants of the ITT population, who were documented for a total of 126 days of the treatment period.||ng/ml||95% Confidence Interval|Median
634674|NCT02716779|Secondary|Area Under the Concentration-Time Curve (AUC) of PEG-IFN|Evaluation of PEG-IFN arm after Day 0. Evaluation of ribavirin and placebo arms after Day 42.|From Day 0 at 0 hour (hr), 24 hr, 48 hr and 72 hr, Day 42 at 0 hr and 24 hr and at approximately every other visit up to Day 126|All evaluable participants of the ITT population, who were documented for a total of 126 days of the treatment period.||(nanogram/milliliter)*day ([ng/ml]*d)||95% Confidence Interval|Median
634675|NCT02716779|Secondary|Time to Maximum Concentration (Tmax) of Ribavirin|Tmax was obtained directly from the concentration-time data. Evaluation of ribavirin arm after day 0. Evaluation of placebo and PEG-IFN arms after day 42.|From Day 0 at 0 hour (hr), 12 hr, 24 hr, 36 hr, 48 hr, 60 hr and 72 hr, Day 42 at 0 hr, 12 hr, 24 hr and 36 hr and at each visit up to Day 126.|All evaluable participants of the ITT population, who were documented for a total of 126 days of the treatment period.||weeks||95% Confidence Interval|Median
634676|NCT02716779|Secondary|Maximum Concentration (Cmax) of Ribavirin|Cmax was obtained directly from the concentration-time data. Evaluation of ribavirin arm after day 0. Evaluation of placebo and PEG-IFN arms after day 42.|From Day 0 at 0 hour (hr), 12 hr, 24 hr, 36 hr, 48 hr, 60 hr and 72 hr, Day 42 at 0 hr, 12 hr, 24 hr and 36 hr and at each visit up to Day 126.|All evaluable participants of the ITT population, who were documented for a total of 126 days of the treatment period.||mcg/ml||95% Confidence Interval|Median
634688|NCT02712333|Secondary|Pulse Pressure|To eliminate possible error, blood pressure for each participant were conducted by the same working staff using the same instrument. Average levels were calculated by treatments (intervention or control).|at the end of each 9-day intervention|||mmHg||Standard Deviation|Mean
634677|NCT02716779|Secondary|Area Under the Concentration-Time Curve (AUC) of Ribavirin|Evaluation of ribavirin arm after Day 0. Evaluation of placebo and PEG-IFN arms after Day 42.|From Day 0 at 0 hour (hr), 12 hr, 24 hr, 36 hr, 48 hr, 60 hr and 72 hr, Day 42 at 0 hr, 12 hr, 24 hr and 36 hr and at each visit up to Day 126.|All evaluable participants of the ITT population, who were documented for a total of 126 days of the treatment period.||(microgram/milliliter)*day ([mcg/ml]*d)||95% Confidence Interval|Median
634678|NCT02716779|Secondary|Percentage of Participants With Treatment Response|HCV-RNA level was measured at each visit by a central laboratory. Treatment response was estimated applying the following definitions of response/non-response: 1) Adequate first phase decline: HCV RNA decline ≥ 0.5 log10 International Units/milliliter (IU/mL) from time 0 to 48 hours of PEG-IFN treatment (PEG-IFN arm: day 0 – day 2; placebo and ribavirin arm: day 42-day 44), 2) Rapid virologic response: HCV RNA < 15 IU/mL (=detection limit) on day 70, 3) Complete early virologic response: HCV RNA < 15 IU/mL on day 126, 4) Partial early virologic response (log decrease): HCV RNA decrease ≥ 2 log10 IU/mL from day 0 to day 126, 5) Partial early virologic response (cut off): HCV RNA <30000 IU/mL on day 126, 6) Non-response: HCV RNA decrease <2 log10 IU/mL from day 0 to day 126, 7) Null-response: HCV RNA decrease <1 log10 IU/mL from day 0 to day 28 and from day 0 to day 70 for PEG-IFN arm and placebo / ribavirin arm, respectively.|Up to Day 126|All evaluable participants of the Intent-to-Treat (ITT) population, who were documented for a total of 126 days of the treatment period.||percentage of participants|||Number
634679|NCT02716779|Secondary|Score in Quality of Life Assessed Using Short Form-36 (SF-36) Health Questionnaire|SF-36 is a psychometric scale to quantify health conditions. This psychometric scale has 8 dimensions of the subjective health status and consists of 36 individual items that have a varying number of related item scores (ranging from “yes/no” up to a 6-point scale). At first the raw scores were determined by summation over all items and weighted accordingly. Afterwards the raw scores were transformed to ranges of 0-100 with 100 being the highest level of health and compared to published reference scales. The following eight dimensions of subjective health conditions were considered: physical functioning index, role physical index, pain, general health perception, vitality, social functioning index, role emotional index and mental health index. The SF36 questionnaire had to be answered by the patients at screening before monotherapy, after monotherapy and at the end of the study (=end of combination therapy).|At screening (Days -56 to -1), at end of monotherapy (Week 6) and at end of combination therapy (Week 18)|Intent-to-treat (ITT) population includes all randomized participants who received at least one dose of study drug. Here, 'n' is the number of evaluable participants.||units on a scale||Standard Deviation|Mean
634680|NCT02716779|Primary|Log Likelihood Median Values of Hepatitis C-Virus (HCV) Kinetic Models for Quantitative HCV Ribonucleic Acid (RNA) Measurement With Various Assumptions of Ribavirin Mechanism of Action|To investigate possible action mechanisms, three different models were fitted to viruskinetic data and evaluated using related log-likelihood function values. These models were designed assuming individual effects with respect to infectiousness (model 1), virus production (model 2) or degradation of infected cells rate (model 3). The following viruskinetic parameters were fitted in each model: initial viral load, loss rate of infected cells (delta), effectivity of interferon with respect to a pharmacokinetic-pharmacodynamic model. A lower log likelihood function value indicates a lesser fit for the model.|Up to Day 126|Per Protocol (PP) population: participants with 6 weeks of monotherapy and at least 4 weeks combination therapy as well as three quantitative HCV-RNA measurements (baseline, period 1, period 2), no major protocol violations, no treatment interruption and no dose reduction below 80% of the planned medication within the first 10 therapy weeks.||log likelihood function value||95% Confidence Interval|Median
634681|NCT02716298|Primary|Surface Deposits|Surface deposits for fanfilcon A and lotrafilcon B lens. (Scale 0-4, 0.25 steps, 0=excellent, 4=severely reduced)|Baseline, 1 month|One participant excluded from analysis at 1 month.||units on a scale||Standard Deviation|Mean
634682|NCT02716298|Primary|Lens Wettability|Lens wettability for fanfilcon A and lotrafilcon B lens. (Scale 0-4, 0.25 steps, 0=excellent, 4=severely reduced)|Baseline, 1 month|One participant excluded from analysis at 1 month.||units on a scale||Standard Deviation|Mean
634683|NCT02716298|Primary|Subjective Preference|"Subjective ratings on preference for fanfilcon A and lotrafilcon B lens. (Strongly prefer fanfilcon A, slightly prefer fanfilcon A, no preference, slightly prefer lotrafilcon B, strongly prefer lotrafilcon B).
Subject preference in terms of comfort, dryness, clear vision, Lens Handling, digital devices, all day natural comfort, All day comfort, same comfort at the end of the day (EOD), comfortable after the end of 4 weeks, Same comfort at 4 weeks as initial, comfortable in dry environments, help focus effortlessly while using digital devices, help with end of day (EOD) dryness, help eyes feel less tired at EOD (including computer or digital device use), offering clear vision during driving."|1 month|||percentage of participants|||Number
634684|NCT02716298|Primary|Subjective Comfort|Subjective ratings on comfort at insertion (at baseline), comfort when lenses are first put in, comfort during the day's wear, and comfort prior to lens removal (1 month) for fanfilcon A and lotrafilcon B lens. (Scale 0-10, 10=Can't feel the lenses, 0=Painful).|Baseline, 1 month|||units on a scale||Standard Deviation|Median
634685|NCT02713594|Secondary|Cost-effectiveness|This analysis will quantify the costs of treatment for Control and Incentive conditions with regard to attaining 6-month abstinence. Project costs were allocated to three categories: 1) Service costs, including billed staff time for counseling and testing, as well as all incidentals connected with services; 2) Incentives and distribution costs; and 3) Service-related administrative costs, including promotion/marketing and staff time for administering the intervention. Costs of planning the project, grant administration, and research within the project are not included in the analysis.The outcome is the cost per quit in each treatment group. Cost per quit in each group was calculated by: 1) computing the grand total of costs for all participants in a given group; and 2) dividing the grand total for a given group by the number of successful quitters. As such, the cost per quit is a single value with no measure of dispersion.|Measured 6 months after enrollment|||U.S. Dollars|||Number
634686|NCT02713594|Secondary|Engagement in Treatment|This analysis will compare number of calls completed|Measured 6 months after enrollment at follow-up assessment|||Participants|||Count of Participants
634687|NCT02713594|Primary|Abstinence From Smoking|The primary outcome data will be the biochemically confirmed abstinence using urine (measured cotinine) or exhaled (breath) carbon monoxide (CO).|Measured 6 months after enrollment at follow-up assessment|||Participants|||Count of Participants
639653|NCT02387554|Primary|Cmax|Cmax(maxium concentration)|0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr||||||
634689|NCT02712333|Secondary|Diastolic Blood Pressure|To eliminate possible error, blood pressure for each participant were conducted by the same working staff using the same instrument. Average levels were calculated by treatments (intervention or control).|at the end of each 9-day intervention|||mmHg||Standard Deviation|Mean
634690|NCT02712333|Secondary|Systolic Blood Pressure|To eliminate possible error, blood pressure for each participant were conducted by the same working staff using the same instrument. Average levels were calculated by treatments (intervention or control).|at the end of each 9-day intervention period|||mmHg||Standard Deviation|Mean
634691|NCT02712333|Primary|Changes of Serum Norepinephrine Concentration|"Use metabolomic methods to screen and quantify all the serum metabolites, and calculate changes in main metabolites in sham purification compared to real purification.
Relative intensity was calculated by dividing the peak intensity of cortisol with the peak intensity of internal standard (2-chloro-D-phenylalanine methanol solution, 0.014mg/mL)"|at the end of each 9-day intervention|||relative intensity||Standard Deviation|Mean
634692|NCT02712333|Primary|Changes of Serum Epinephrine Concentrations|"Use metabolomic methods to screen and quantify all the serum metabolites, and calculate changes in main metabolites in sham purification compared to real purification.
Relative intensity was calculated by dividing the peak intensity of epinephrine with the peak intensity of internal standard (2-chloro-D-phenylalanine methanol solution, 0.014mg/mL)"|at the end of each 9-day intervention|||relative intensity||Standard Error|Mean
634693|NCT02712333|Primary|Changes of Serum Cortisone Concentration|"Use metabolomic methods to screen and quantify all the serum metabolites, and calculate changes in main metabolites in sham purification compared to real purification.
Relative intensity was calculated by dividing the peak intensity of cortisone with the peak intensity of internal standard (2-chloro-D-phenylalanine methanol solution, 0.014mg/mL)"|at the end of each 9-day intervention period|||relative intensity||Standard Error|Mean
634694|NCT02712333|Primary|Changes of Serum Cortisol Levels|"Using metabolomic methods to screen and quantify all the serum metabolites, and calculate changes in main metabolites in sham purification compared to real purification.
Relative intensity was calculated by dividing the peak intensity of cortisol with the peak intensity of internal standard (2-chloro-D-phenylalanine methanol solution, 0.014mg/mL)"|at the end of each 9-day intervention period|||relative intensity||Standard Deviation|Mean
634695|NCT02712099|Secondary|Abnormal Placental Lacunae by 3D Tomographic Ultrasound Imaging (TUI)|3D tomographic ultrasound imaging (TUI) of placenta previa with its lower edge covering the scar of previous cesarean section the examiner can simultaneously display, on the monitor or on a hard copy, up to 24 preselected parallel cuts from a volume. The slices can be generated either along the initial or any other reconstructed plane of the region of interest (ROI) in intervals of 0.5 - to 5 mm segments. Slice thickness will be adjusted as necessary for each individual case. The most informative image among the multiple images will be displayed with the use of CrossXBeam, a postprocessing tool that allows one to enhance tissue and border differentiation, leading to sharper depiction of the tissue margins|28 -36 weeks of gestation|||participants|||Number
634696|NCT02712099|Secondary|Crowded Vessels Over Peripheral Sub-placental Zone by 3D Tomographic Ultrasound Imaging (TUI)|the examiner can simultaneously display, on the monitor or on a hard copy, up to 24 preselected parallel cuts from a volume. The slices can be generated either along the initial or any other reconstructed plane of the region of interest (ROI) in intervals of 0.5 - to 5 mm segments. Slice thickness will be adjusted as necessary for each individual case. The most informative image among the multiple images will be displayed with the use of CrossXBeam, a postprocessing tool that allows one to enhance tissue and border differentiation, leading to sharper depiction of the tissue margins|28 -36 weeks of gestation|||participants|||Number
634697|NCT02712099|Secondary|Abnormal Placental Lacunae by Power Doppler Ultrasonography|Power Doppler ultrasonography criteria by Abnormal placental lacunae in placenta previa with its lower edge covering the scar of previous cesarean section|28 -36 weeks of gestation|||participants|||Number
634698|NCT02712099|Secondary|Crowded Vessels Over Peripheral Sub-placental Zone by Power Doppler Ultrasonography|Power Doppler ultrasonography criteria of Crowded vessels over peripheral sub-placental zone of in placenta previa with its lower edge covering the scar of previous cesarean section|28 -36 weeks of gestation|||participants|||Number
634699|NCT02712099|Primary|Abnormal Placental Lacunae by 2D Grayscale Ultrasonography|2D grayscale ultrasonography criteria of placenta accreta by Abnormal placental lacunae in placenta previa with its lower edge covering the scar of previous cesarean section|28 -36 weeks of gestation|||participants|||Number
634700|NCT02712099|Primary|Loss of the Retro Placental Sonolucent Zone by 2D Grayscale Ultrasonography|2D grayscale ultrasonography criteria of placenta accreta by Loss of the retro placental sonolucent zone in placenta previa with its lower edge covering the scar of previous cesarean section|28 -36 weeks of gestation|||participants|||Number
634701|NCT02710630|Secondary|AUC0-infinity (Area Under the Concentration-time Curve of Total Dabigatran in Plasma Over the Time Interval From 0 Extrapolated to Infinity) (if Applicable)|This outcome measure presents area under the concentration-time curve of total Dabigatran in plasma over the time interval from 0 extrapolated to infinity)(if applicable).|1:00 [hour (h): minute] before drug administration and 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h, 48:00h after drug administration.|"The PharmacoKinetic (PK) parameter analysis Set (PKS): Included all subjects of the treated set who provided at least one primary or secondary PK parameter.
PK Set 2 (PKS2): Included all subjects in the PKS who had evaluable PK variable of the reference treatment and at least one of the 5 test treatments.
PKS2 was used for statistical analyses."||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
634702|NCT02710630|Secondary|Cmax (Maximum Plasma Concentration of Total Dabigatran)|This outcome measure presents maximum concentration of analyte in plasma (Cmax).|1:00 [hour (h): minute] before drug administration and 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h, 48:00h after drug administration.|"The PharmacoKinetic (PK) parameter analysis Set (PKS): Included all subjects of the treated set who provided at least one primary or secondary PK parameter.
PK Set 2 (PKS2): Included all subjects in the PKS who had evaluable PK variable of the reference treatment and at least one of the 5 test treatments.
PKS2 was used for statistical analyses."||ng/mL||Geometric Coefficient of Variation|Geometric Mean
634729|NCT02708212|Secondary|Overall Duration of BDE Examinations|The overall duration of both EGD and colonoscopy examinations was recorded and compared.|On the day of bidirectional endoscopy|||minutes||Standard Deviation|Mean
641022|NCT02324660|Primary|COPD Diagnosis|COPD diagnosis confirmed by spirometry|2 months after inclusion|||participants|||Number
634703|NCT02710630|Secondary|AUC0-tz (Area Under the Concentration-time Curve of Total Dabigatran in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point)|This outcome measure presents area under the concentration-time curve of total Dabigatran in plasma over the time interval from 0 to the time of the last quantifiable data point.|1:00 [hour (h): minute] before drug administration and 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h, 48:00h after drug administration.|"The PharmacoKinetic (PK) parameter analysis Set (PKS): Included all subjects of the treated set who provided at least one primary or secondary PK parameter.
PK Set 2 (PKS2): Included all subjects in the PKS who had evaluable PK variable of the reference treatment and at least one of the 5 test treatments.
PKS2 was used for statistical analyses."||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
634704|NCT02710630|Secondary|AUC0-infinity (Area Under the Concentration-time Curve of Free Dabigatran in Plasma Over the Time Interval From 0 Extrapolated to Infinity) (if Applicable)|This outcome measure presents area under the concentration-time curve of free Dabigatran in plasma over the time interval from 0 extrapolated to infinity)(if applicable).|1:00 [hour (h): minute] before drug administration and 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h, 48:00h after drug administration.|"The PharmacoKinetic (PK) parameter analysis Set (PKS): Included all subjects of the treated set who provided at least one primary or secondary PK parameter.
PK Set 2 (PKS2): Included all subjects in the PKS who had evaluable PK variable of the reference treatment and at least one of the 5 test treatments.
PKS2 was used for statistical analyses."||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
634705|NCT02710630|Primary|Cmax (Maximum Concentration of Free Dabigatran)|This outcome measure presents maximum concentration of analyte in plasma (Cmax).|1:00 [hour (h): minute] before drug administration and 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h, 48:00h after drug administration.|The PharmacoKinetic (PK) parameter analysis Set (PKS): This analysis set included all subjects of the treated set who provided at least one primary or secondary PK parameter. Thus, a subject was included in the PKS, even if the subject contributed only one PK parameter value for one period to the statistical assessment.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
634706|NCT02710630|Primary|AUC0-tz (Area Under the Concentration-time Curve of Free Dabigatran in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point)|This outcome measure presents area under the concentration-time curve of free Dabigatran in plasma over the time interval from 0 to the time of the last quantifiable data point.|1:00 [hour (h): minute] before drug administration and 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h, 48:00h after drug administration.|The PharmacoKinetic (PK) parameter analysis Set (PKS): This analysis set included all subjects of the treated set who provided at least one primary or secondary PK parameter. Thus, a subject was included in the PKS, even if the subject contributed only one PK parameter value for one period to the statistical assessment.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
634707|NCT02710292|Primary|Percentage of Subjects With Investigator-rated Lens Centration of “Optimal” After 10 Days of Wear|Lens centration was assessed by the investigator on a 5-point scale, where 0=Optimal and 4=Severe decentration (with corneal exposure). Both eyes contributed to the analysis.|Day 10, each product|This analysis population includes all subjects who used the study device and in whom data after the use of the study device were available (Full Analysis Set).||percentage of subjects|||Number
634708|NCT02709577|Secondary|Absolute Weight Change||24 weeks or 52 weeks|||kg||Standard Deviation|Mean
634709|NCT02709577|Primary|Change in HbA1c Values From Baseline Measurement|"Cohort A: Assessment of improvement in the glycemic control defined as a change in HbA1c values from baseline.
Cohort B. Assessment of improvement in glycemic control defined as a change in HbA1c values of at least 0.5% from baseline."|Baseline to 24 weeks or 52 weeks|||percentage of HbA1c||Standard Deviation|Mean
634710|NCT02709096|Primary|Logarithmic Change in Colony Counts of Facial Propionibacterium Acnes|P. Acnes cultures will be collected using the modified Kligman Method at each study visit. After plating, the samples will be cultured for 7 days and then evaluated.|Cultures will be evaluated at Baseline, Week 1, Week 2, Week 4 and Week 6. Values reported at week 4 compared to baseline.|Per protocol population included all subjects with evaluable data and no major protocol violations.||log change in colony forming units||Standard Deviation|Mean
634711|NCT02708524|Secondary|Overall Opinion Individual Item|Overall Opinion was assessed using a questionnaire item at Post Fit, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are on a 5 likert scale (Excellent, Very Good, Good, Fair and Poor). Only the percentage of participants that reported Excellent or Very good (Top-Two-Box) was reported here.|Up to 1 month Follow-up|Subjects that completed all study visits without a major protocol deviation.||percentage of participants|||Number
634712|NCT02708524|Secondary|Overall Quality of Vision Individual Item|Overall Quality of Vision was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are on a 5 likert scale (Excellent, Very Good, Good, Fair and Poor). Only the number of participants that reported Excellent or Very good (Top-Two-Box) was reported here.|Up to 1 month Follow-up|Subjects that completed all study visits without a major protocol deviation.||percentage of participants|||Number
634713|NCT02708524|Secondary|Subjective Overall Quality of Vision Composite Score|Subjective Overall Quality of Vision was evaluated using the Contact Lens User Experience Comfort scores (CLUE). CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. CLUE was collect at Baseline, Post Lens Fit 1-, 2-, 3- and 4- week follow-ups.|Up to 1 month Follow-up|Subjects that completed all study visits without a major protocol deviation.||units on a scale||Standard Deviation|Mean
634714|NCT02708524|Primary|Making Your Eyes Feel Moist Throughout the Day Individual Item|Making your eyes feel moist throughout the day was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are on a 5 likert scale (Excellent, Very Good, Good, Fair and Poor). Only the percentage of participants that reported Excellent or Very good (Top-Two-Box) was reported here.|Up to 1 month Follow-up|Subjects that completed all study visits without a major protocol deviation.||percentage of participants|||Number
639126|NCT02406937|Secondary|Crying Time|Questionnaire recorded by parents. Average crying time per day during the measurement week.|Baseline, Week 4, Week 8, Week 12|||minutes/day||Standard Deviation|Mean
634715|NCT02708524|Primary|Frequency of Experiencing Dryness Individual Item|Frequency of Experiencing Dryness was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are scaled as (Always, Frequently, Occasionally, Rarely, Never or Don't Know). Only the number of participants that reported Rarely or Never (Top-Two-Box) was reported here.|1 month Follow-up|Subjects that completed all study visits without a major protocol deviation.||percentage of participants|||Number
634716|NCT02708524|Primary|Frequency of Lens Awareness Individual Item|Frequency of Lens Awareness was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are scaled as (Always, Frequently, Occasionally, Rarely, Never or Don't Know). Only the number of participants that reported Rarely or Never (Top-Two-Box) was reported here.|1 month Follow-up|Subjects that completed all study visits without a major protocol deviation.||percentage of participants|||Number
634717|NCT02708524|Primary|Comfort Each and Everyday Individual Item|Comfort each and everyday was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are on a 5 likert scale (Excellent, Very Good, Good, Fair and Poor). Only the percentage of participants that reported Excellent or Very good (Top-Two-Box) was reported here.|1 month Follow-up|Subjects that completed all study visits without a major protocol deviation.||percentage of participants|||Number
634718|NCT02708524|Primary|Comfort at the End of the Day Individual Item|Comfort at the End of the Day was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are on a 5 like-rt scale (Excellent, Very Good, Good, Fair and Poor). Only the percentage of participants that reported Excellent or Very good (Top-Two-Box) was reported here.|1 month Follow-up|Subjects that completed all study visits without a major protocol deviation.||percentage of participants|||Number
634719|NCT02708524|Primary|Overall Comfort Individual Item|Overall Comfort was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Responses are on a 5 likert scale (Excellent, Very Good, Good, Fair and Poor). Only the percentage of participants that reported Excellent or Very good (Top-Two-Box) was reported here.|1 month follow-up|Subjects that completed all study visits without a major protocol deviation.||percentage of participants|||Number
634720|NCT02708524|Primary|Subjective Overall Comfort Composite Score|Subjective Overall Comfort was evaluated using the Contact Lens User Experience Comfort scores (CLUE). CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.Range is 0 to 120. CLUE was collect at Baseline, Post Lens Fit 1-, 2-, 3- and 4- week follow-ups.|Up to 1 month Follow-up|All subjects that completed all study visits without a major protocol deviation.||average clue score||Standard Deviation|Mean
634721|NCT02708355|Primary|Change From Baseline at Day 14 in Percentage of Time Over 24-­Hour Period With Intra Gastric pH Greater Than (>)4|Percentage of time was calculated over the 24 hour period during which intra gastric pH >4 was observed. Relief of 24 hour heartburn was defined as a daily diary response of “0” to the question “Over the last 24 hours (yesterday and last night), what was the severity of your most intense episode of heartburn?” on at least 6 of the participant’s last 7 consecutive days [Days 8 – 14] of treatment allowing for one day with a maximum severity of “2”.The response was noted by participants in the diary for last 7 consecutive days [Day 8 – 14] on a 3 point scale ranged from 0 to 2 where 0= complete relief and 2= maximum severity. Higher score indicated worse condition/more severity. In this outcome, change from baseline at Day 14 in percentage of time over the 24 hour period during which intra gastric pH >4 was observed, was reported.|Baseline, Day 14|Per protocol analysis set included all randomized participants who provided valid data for Day -1 PH monitoring, take at least one dose of randomized study medication, complete the 14 day treatment phase, undergo and provide valid data for Day 14 pH monitoring and complete at least 5 days of diary entries in each of Days -7 to -1 and Days 8 to 14.||percentage of time||Standard Deviation|Mean
634722|NCT02708355|Primary|Number of Participants With Relief of 24 Hour Heartburn and Without Relief of 24 Hour Heartburn|Relief of 24 hour heartburn was defined as a daily diary response of “0” to the question “Over the last 24 hours (yesterday and last night), what was the severity of your most intense episode of heartburn?” on at least 6 of the participant’s last 7 consecutive days [Days 8 – 14] of treatment allowing for one day with a maximum severity of “2”.The response was noted by participants in the diary for last 7 consecutive days [Day 8 – 14] on a 3 point scale ranged from 0 to 2 where 0= complete relief and 2= maximum severity. Higher score indicated worse condition/more severity. In this outcome measure, participants with relief of 24 hour heartburn and participants without relief of 24 hour heartburn were reported.|Day 8 up to Day 14|Per protocol analysis set included all randomized participants who provided valid data for Day -1 PH monitoring, take at least one dose of randomized study medication, complete the 14 day treatment phase, undergo and provide valid data for Day 14 pH monitoring and complete at least 5 days of diary entries in each of Days -7 to -1 and Days 8 to 14.||participants|||Number
634723|NCT02708277|Secondary|Number of Participants With Reformation of Intrauterine Adhesions in Loop-shaped Intrauterine Device Group and Intrauterine Balloon Group||Within the first 3 months after surgery|||participants|||Number
634724|NCT02708277|Secondary|Endometrial Thickness of All Participants in the Mid Menstrual Measured by Color Doppler Ultrasound||Within the first 3 months after surgery|||mm||Standard Deviation|Mean
634725|NCT02708277|Secondary|Menstruation Pattern(Improvement or No Significant Change) of All Participants|Comparing with preoperative and postoperative menstrual duration, numbers of sanitary napkin using and wet area ratio of sanitary napkin to judgment whether menstrual quantity is improvement in patients|Within the first 3 months after surgery|||participants|||Number
634726|NCT02708277|Primary|Number of Participants With Pregnancy in Loop-shaped Intrauterine Device Group and Intrauterine Balloon Group||three years|||participants|||Number
634727|NCT02708238|Secondary|Number of Responders|Number of responders defined as the number of patients who experienced a decrease in the daily average crying time of 50% from baseline|28 days of treatment|||number of responders|||Number
634728|NCT02708238|Primary|Median Daily Crying Time at the End of the Treatment|Median daily crying at the end of treatment (day 28).|28 days of treatment|||minutes||Full Range|Median
639174|NCT02404649|Secondary|To Assess Implant Survival||2 years||||||
639175|NCT02404649|Secondary|Evaluate Crestal Bone Levels||2 years||||||
634730|NCT02708212|Primary|Sedative Doses of Midazolam|During bidirectional endoscopy, the total doses of midazolam were recorded and compared between the two study groups.|On the day of bidirectional endoscopy procedures|||mg/kg||Standard Deviation|Mean
634731|NCT02708212|Primary|Sedative Doses of Fentanyl|During bidirectional endoscopy, the total doses of fentanyl were recorded and compared between the two study groups.|On the day of endoscopic procedures.|||mcg/kg||Standard Deviation|Mean
634732|NCT02707640|Primary|Percentage of Participants With Treatment-Emergent Adverse Events That Led to Dose Reduction or Temporary Discontinuation of Study Treatment||Until 28 days from last dose of study treatment (Week 28)|mITT population included who received at least 1 dose of double-blind study medication (NAC or placebo).||percentage of participants|||Number
634733|NCT02707640|Primary|Percentage of Participants With Treatment-Emergent Deaths of All Causes||Until 28 days from last dose of study treatment (Week 28)|mITT population included who received at least 1 dose of double-blind study medication (NAC or placebo).||percentage of participants|||Number
634734|NCT02707640|Primary|Percentage of Participants With Treatment-Emergent Adverse Events Resulting in Permanent Discontinuation of Study Treatment||Until 28 days from last dose of study treatment (Week 28)|mITT population included who received at least 1 dose of double-blind study medication (NAC or placebo).||percentage of participants|||Number
634735|NCT02707640|Primary|Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs)|A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, is life threatening, requires hospitalization or prolongation of hospitalization, or results in disability/incapacity, or congenital anomaly/birth defect.|Until 28 days from last dose of study treatment (Week 28)|mITT population included who received at least 1 dose of double-blind study medication (NAC or placebo).||percentage of participants|||Number
634736|NCT02707640|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)|An adverse event (AE) is defined as any untoward medical occurrence in a participant who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment.|Until 28 days from last dose of study treatment (Week 28)|mITT Population included participants who received at least 1 dose of double-blind study medication (NAC or placebo).||percentage of participants|||Number
634737|NCT02707640|Primary|Percentage of Participants With Early Treatment Discontinuations|Percentage of participants with early treatment discontinuations in N-Acetylcysteine and placebo cohorts during the 24-week treatment period.|From baseline up to 24 weeks|mITT population included participants who received at least 1 dose of double-blind study medication (NAC or placebo).||percentage of participants|||Number
634738|NCT02707640|Primary|Percentage of Participants With Dose Reductions|Percentage of participants with dose reductions in N-Acetylcysteine and placebo cohorts during the 24-week treatment period.|From baseline up to 24 weeks|mITT population included participants who received at least 1 dose of double-blind study medication (NAC or placebo).||percentage of participants|||Number
634739|NCT02707172|Primary|Amount of Diethylhexyl Phthalate Removed From Hand|Water rinse were performed immediately after hand-washing, and the concentration of diethylhexyl phthalate in the soiled water is measured.|immediately right after hand-washing|Each participant underwent two sets of experiments, one with placebo and one with intervention. 14 participants received placebo first and were crossed-over to received intervention. The other 14 participants received intervention first and were crossed-over to received placebo.||percentage of DEHP removed||Standard Deviation|Mean
634785|NCT02701296|Secondary|Plantar Flexion in the Tibial Nerve Distribution|Blinded nurse assessment on a 3-point scale 0= normal (No Motor Block), 1= weak (Partial Motor Block), 2 = absent (Complete Motor Block)|Upon emergence from anesthesia in the PACU|||Participants|||Count of Participants
639176|NCT02404649|Secondary|Level of Bone Maturation||2 years||||||
634745|NCT02705807|Secondary|Change From Baseline in Cardiac Output (CO)|Cardiac output is the volume of blood pumped by the heart per minute. The Baseline values are those collected within 0.5 hr prior to the first dose of the new diluent formulation (‘Visit 2 - Baseline’). Change from Baseline is defined as the difference between the post-dose visit value and the Baseline value.|Baseline and up to Week 4|ITT population||liter/minute||Standard Deviation|Mean
634746|NCT02705807|Secondary|Change From Baseline in Pulmonary Vascular Resist (PVR)|The Baseline values are those collected within 0.5 hr prior to the first dose of the new diluent formulation (‘Visit 2 - Baseline’). Change from Baseline is defined as the difference between the post-dose visit value and the Baseline value.|Baseline and up to Week 4|ITT population||millimeter mercury/liter/minute||Standard Deviation|Mean
634747|NCT02705807|Secondary|Change From Baseline in Mean Pulmonary Arterial Pressure (mPAP) and Mean Right Atrial Pressure (mRAP)|mPAP and mRAP are hemodynamic parameters. The Baseline values are those collected within 0.5 hr prior to the first dose of the new diluent formulation (‘Visit 2 - Baseline’). Change from Baseline is defined as the difference between the post-dose visit value and the Baseline value.|Baseline and up to Week 4|ITT Population||mmHg||Standard Deviation|Mean
634748|NCT02705807|Secondary|Number of Participants With Change of WHO Functional Class From Previous Visit|WHO Functional Classification of physical activity limitations: I (no limitation) and IV (unable to carry out any physical activity without symptoms). The change from baseline in WHO class was classified as Improved (decrease in functional class), No Change (functional class stayed the same), and Deteriorated (functional class increased). The change from baseline in WHO functional class at Week 4 has been presented in the table. The Baseline values are those collected within 0.5 hr prior to the first dose of the new diluent formulation (‘Visit 2 - Baseline’)|Up to Week 4|ITT population||Participants|||Number
634749|NCT02705807|Secondary|Number of Participants in Each World Health Organization (WHO) Functional Class|The WHO functional classes of PAH range from Class I (without limitation in physical activity) to Class IV (inability to perform a physical activity without any symptoms).|Baseline and Week 4|ITT population||Participants|||Number
634750|NCT02705807|Secondary|Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT Pro BNP)|Blood samples were collected at Baseline, 24 hours after the first dose of thermostable formulation of FLOLAN, and Week 4 for measurement of NT pro BNP. The Baseline values are those collected within 0.5 hr prior to the first dose of the new diluent formulation (‘Visit 2 - Baseline’). Change from Baseline is defined as the difference between the post-dose visit value and the Baseline value.|Baseline and up to Week 4|ITT population||nanogram/liter||Standard Deviation|Mean
634751|NCT02705807|Secondary|Number of Participants With the Reason for the Change Dose of the Thermostable Formulation of FLOLAN|All reasons for FLOLAN dose adjustments after the switch were listed.|Up to Week 4|ITT Population||Participants|||Number
634752|NCT02705807|Secondary|Number of Events to Adjust Dose of FLOLAN Based on the Change From Baseline to 3 Hours in Mean Pulmonary Artery Pressure (mPAP)|To assess the frequency of dose adjustment requirements based on the changes from baseline in mPAP up to 3 hours after dosing.The Baseline values are those collected within 0.5 hr prior to the first dose of the new diluent formulation (‘Visit 2 - Baseline’). Participants who gave consent to undergo right heart catheterisation (RHC) over 24-hour and at week 4 were assessed. Change from Baseline is defined as the difference between the post-dose visit value and the Baseline value.|Up to Week 4|ITT population||Number of events|||Number
634753|NCT02705807|Primary|Absolute Values of Oxygen Saturation|Oxygen saturation was measured by pulse oximetry at Baseline (BL), 1 hr, 3 hr, 24 hr, Week 4 (W4). The Baseline values are those collected within 0.5 hr prior to the first dose of the new diluent formulation (‘Visit 2 - Baseline’).|Baseline and up to Week 4|ITT population||Percentage||Standard Deviation|Mean
634754|NCT02705807|Primary|Change From Baseline in Body Weight|Body weight was measured at Baseline (BL) and Week 4 (W4). The Baseline values are those collected within 0.5 hr prior to the first dose of the new diluent formulation (‘Visit 2 - Baseline’). Change from Baseline is defined as the difference between the post-dose visit value and the Baseline value. Participants with body weight outside and within the clinical concern reference range (<50kg) has been presented.|Baseline and Week 4|ITT population||Participants|||Number
634755|NCT02705807|Primary|Change From Baseline in Heart Rate|Heart rate was measured at Baseline, 1 hr, 3 hr, 24 hr, Week 4 (W4). The Baseline values are those collected within 0.5 hr prior to the first dose of the new diluent formulation (‘Visit 2 - Baseline’). Change from Baseline is defined as the difference between the post-dose visit value and the Baseline value.|Baseline and up to Week 4|ITT population||Beats per minute (bpm)||Standard Deviation|Mean
634756|NCT02705807|Primary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|SBP and DBP were measured at Baseline, 1 hr, 3 hr, 24 hr, Week 4 (W4). The Baseline values are those collected within 0.5 hr prior to the first dose of the new diluent formulation (‘Visit 2 - Baseline’). Change from Baseline is defined as the difference between the post-dose visit value and the Baseline value.|Baseline, 1 hour, 3 hour, 24 hour and Week 4|ITT population||Millimeters of mercury (mmHg)||Standard Deviation|Mean
634757|NCT02705807|Primary|Number of Participants With the Indicated Electrocardiogram (ECG) Findings|A safety 12-lead ECG was performed at Baseline (BL), 24 hr after switching to the new Flolan diluent and Week 4 (W4). Any abnormal clinically significant (CS) and not clinically significant (NCS) findings were reported. ECG abnormaility with respect to CS and NCS findings were judged by the investigator. The Baseline values are those collected within 0.5 hr prior to the first dose of the new diluent formulation (‘Visit 2 - Baseline’)|Baseline, 24 hour and Week 4|ITT population||Participants|||Number
634758|NCT02705807|Primary|Number of Participants With the Indicated Urinalysis Findings|Urine protein, urine glucose, and occult blood were assessed at Baseline (BL) and Week 4 (W4). Dipstick test was performed for routine urinalysis. Abnormal values such as trace, 1+, 2+, 3+ and positive have been reported. The Baseline values are those collected within 0.5 hr prior to the first dose of the new diluent formulation (‘Visit 2 - Baseline’).|Baseline and Week 4|ITT population||Participants|||Number
678518|NCT01596842|Secondary|Changes of Calcium Levels||4 weeks, 8 weeks and 12 weeks||||||
634759|NCT02705807|Primary|Absolute Values of Thyroid Stimulating Hormone at Baseline and Week 4|Blood samples were collected for measurement of Thyroid Stimulating Hormone (TSH) at Baseline (BL) and Week 4 (W4). The Baseline values are those collected within 0.5 hr prior to the first dose of the new diluent formulation (‘Visit 2 - Baseline’)|Baseline and Week 4|ITT population||milliunits per litre (mU/L)||Standard Deviation|Mean
634760|NCT02705807|Primary|Absolute Values of Free Triiodothyronine and Free Thyroxine at Baseline and Week 4|Blood samples were collected for measurement of Free Triiodothyronine (FT3) and Free Thyroxine (FT4) at Baseline (BL) and Week 4 (W4). The Baseline values are those collected within 0.5 hr prior to the first dose of the new diluent formulation (‘Visit 2 - Baseline’)|Baseline and Week 4|ITT population||picomoles per litre (pmol/L)||Standard Deviation|Mean
634761|NCT02705807|Primary|Absolute Values of Urea/Blood Urea Nitrogen, Glucose, Chloride, Sodium, Potassium, Magnesium, Phosphorus (Inorganic), and Calcium at Baseline and Week 4|Blood samples were collected for measurement of urea/Blood Urea Nitrogen (Urea/BUN), glucose, chloride, sodium, potassium, magnesium, phosphorus, inorganic, and calcium at Baseline (BL) and Week 4 (W4). The Baseline values are those collected within 0.5 hr prior to the first dose of the new diluent formulation (‘Visit 2 - Baseline’)|Baseline and Week 4|ITT population||Millimoles per litre (mmol/L)||Standard Deviation|Mean
634762|NCT02705807|Primary|Absolute Values of Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Gamma Glutamyltransferase, Lactate Dehydrogenase and Creatine Kinase at Baseline and Week 4|Blood samples were collected for measurement of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), Gamma Glutamyltransferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase (CK) at Baseline (BL) and Week 4 (W4). The Baseline values are those collected within 0.5 hr prior to the first dose of the new diluent formulation (‘Visit 2 - Baseline’)|Baseline and Week 4|ITT population||International units per liter (IU/L)||Standard Deviation|Mean
634763|NCT02705807|Primary|Absolute Values of Total and Direct Bilirubin, Creatinine, and Uric Acid at Baseline and Week 4|Blood samples were collected for measurement of total and direct bilirubin, creatinine (CRT), and uric acid (UA) at Baseline (BL) and Week 4 (W4). The Baseline values are those collected within 0.5 hr prior to the first dose of the new diluent formulation (‘Visit 2 - Baseline’)|Baseline and Week 4|ITT population||Micromoles per liter||Standard Deviation|Mean
634764|NCT02705807|Primary|Absolute Values of Albumin and Total Protein at Baseline and Week 4|Blood samples were collected for measurement of albumin and total protein at Baseline (BL) and Week 4 (W4). The Baseline values are those collected within 0.5 hr prior to the first dose of the new diluent formulation (‘Visit 2 - Baseline’)|Baseline and Week 4|ITT population||G/L||Standard Deviation|Mean
634765|NCT02705807|Primary|Absolute Values of Red Blood Cell Count at Baseline and Week 4|Blood samples were collected for measurement of red blood cells at Baseline (BL) and Week 4 (W4). The Baseline values are those collected within 0.5 hr prior to the first dose of the new diluent formulation (‘Visit 2 - Baseline’)|Baseline and Week 4|ITT population||terabinary/liter (Ti/L))||Standard Deviation|Mean
634766|NCT02705807|Primary|Absolute Values of Platelet Count and White Blood Cell Count at Baseline and Week 4|Blood samples were collected for measurement of platelets and white blood cells (WBC) at Baseline (BL) and Week 4 (W4). The Baseline values are those collected within 0.5 hr prior to the first dose of the new diluent formulation (‘Visit 2 - Baseline’)|Baseline and Week 4|ITT population||Giga/Liter (GI/L)||Standard Deviation|Mean
634767|NCT02705807|Primary|Absolute Values of Hematocrit at Baseline and Week 4|Blood samples were collected for measurement of hematocrit values at Baseline (BL) and Week 4 (W4). The Baseline values are those collected within 0.5 hr prior to the first dose of the new diluent formulation (‘Visit 2 - Baseline’)|Baseline and Week 4|ITT population||Liter (L)||Standard Deviation|Mean
634768|NCT02705807|Primary|Absolute Values of Hemoglobin at Baseline and Week 4|Blood samples were collected for measurement of hemoglobin values at Baseline (BL) and Week 4 (W4). The Baseline values are those collected within 0.5 hr prior to the first dose of the new diluent formulation (‘Visit 2 - Baseline’)|Baseline and Week 4|ITT population||Gram/Liter (G/L)||Standard Deviation|Mean
634769|NCT02705807|Primary|Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in Blood at Baseline and Week 4|Blood samples were collected for the measurement of percentage of basophils, eosinophils, lymphocytes, monocytes, and total neutrophils in blood at Baseline (BL) and Week 4 (W4). The Baseline values are those collected within 0.5 hour (hr) prior to the first dose of the new diluent formulation (‘Visit 2 - Baseline’)|Baseline and Week 4|ITT population||Percentage||Standard Deviation|Mean
634770|NCT02705807|Primary|Number of Participants With Mild, Moderate or Severe AEs|Intensity for an AE and SAE is categorized as mild if an event is easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities; moderate if an event is sufficiently discomforting to interfere with normal everyday activities; severe if that prevents normal everyday activities.|Up to Week 4|ITT population||Participants|||Number
634771|NCT02705807|Primary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, important medical events which may require medical or surgical interventions. Intention-to-Treat (ITT) population: comprised of all participants who have received at least one dose of the thermostable formulation of FLOLAN.|Up to Week 4|ITT population||Participants|||Number
634786|NCT02701296|Secondary|Opioid Consumption|Amount and type of opioid used for the first 24 hours post surgery|24 hours post surgery|Mean consumption of Hydromorphone(mg) post-op day 1||mg||Standard Deviation|Mean
634787|NCT02701296|Primary|Pain Intensity|Pain Intensity is self-reported on a 10-point scale (0=no pain to 10= worst possible) in PACU and every 6 hours for 48 hours post surgery|48 hours post surgery|||mean pain score||Standard Deviation|Mean
634788|NCT02701270|Secondary|Assessment of IAUC (Incremental Area Under the Curve) in Blood Insulin Response||0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 minutes post dose|Participants from whom full set of blood insulin measurements were available.||min*mmol/L||Standard Deviation|Mean
639805|NCT02371759|Primary|Electrocardiogram at 10 Minutes|ECG 5 minutes after local anesthesia injection, 10 minutes after baseline measurement|10th minute|||Participants|||Count of Participants
634772|NCT02705716|Secondary|Change From Baseline in Tactile Threshold on Day 7 and 14|Tactile threshold was assessed by examiner using a constant pressure probe (Yeaple probe) which allowed application of a known force to the dentin surface from 10 g to an upper threshold of 80g in increments of 10 g. The tactile threshold is the maximum pressure applied at which participant do not report any pain or discomfort. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth.|Baseline, Day 7 and Day 14|Analysis for this outcome was conducted on ITT population, defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n=number of participants evaluated at specific time points for each treatment arms respectively.||g||Standard Deviation|Mean
634773|NCT02705716|Secondary|Change From Baseline in Schiff Sensitivity Score on Day 7|Schiff sensitivity score was assessed by examiner as participant’s response to an evaporative (air) stimulus after the stimulation of each individual tooth. Response of participant was scored using Schiff sensitivity scale range of 0-3; 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicates improvement in sensitivity.|Baseline, Day 7|Analysis for this outcome was conducted on ITT population, defined as all participants who were randomized, received study treatment at least once & provided at least one post-baseline (post treatment) assessment of efficacy. Number of participants analyzed is number of participants from ITT population evaluated on Day 7.||score on a scale||Standard Deviation|Mean
634774|NCT02705716|Primary|Change From Baseline in Schiff Sensitivity Score on Day 14|Schiff sensitivity score was assessed by examiner as participant’s response to an evaporative (air) stimulus after the stimulation of each individual tooth. Response of participant was scored using Schiff sensitivity scale range of 0-3; 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicates improvement in sensitivity.|Baseline, Day 14|Analysis for this outcome was conducted on ITT population, defined as all participants who were randomized, received study treatment at least once & provided at least one post-baseline (post treatment) assessment of efficacy. Number of participants analyzed is number of participants from ITT population evaluated on Day 14.||score on a scale||Standard Deviation|Mean
634775|NCT02705365|Secondary|Tobacco Treatment Use|Percentage of patients, comparing intervention and control groups, who during the 1-year study period had referral to Massachusetts Quitline, smoking cessation medication prescribed, or referral to in-person counseling.|Up to 1 year|||Participants|||Count of Participants
634776|NCT02705365|Secondary|Time to Follow-up of Abnormal Results|Mean time to follow-up of abnormal results, comparing intervention and control groups.|Up to 1 year||||||
634777|NCT02705365|Secondary|Chest CT Completion - Subgroup Analyses|Percentage of patients in intervention vs. control groups who had at least one lung CT screening stratified by language spoken, race, age (<> 65 years) and practice site. (subgroup analysis)|Up to 1 year||||||
634778|NCT02705365|Secondary|As-Treated - Chest CT Completion|Percentage of patients who had at least one chest CT (according to billing and EMR data) during the 1-year study period, comparing patients contacted by patient navigator in the intervention group (“as treated” analysis) vs. all patients in control group.|Up to one year||||||
634779|NCT02705365|Primary|Chest CT Completion|Percentage of patients assigned to the intervention and control groups who had at least one chest CT (according to billing and EMR data) during the 1-year study period.|Up to 1 year|||Participants|||Count of Participants
634780|NCT02701556|Primary|The Primary Safety Endpoint Was Statistical Non-inferiority With Respect to the Proportion of Eyes With Any Slit Lamp Findings Greater Than Grade 2 at Any Visit Between the Test and Control Solutions.|A non-inferiority upper bound of 0.05 (5%) was used to assess the difference (Test – Control) in proportions of slit lamp outcomes. Graded slit lamp findings for each eye were graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding).|3 months|||Participants|||Count of Participants
634781|NCT02701387|Primary|Implant Stability Quotient (ISQ) Value as a Measure of Implant Stability in Bone|"Implant Stability Quotient (ISQ) is a scale from 1 to 100, to quantify implant stability in bone (higher values mean higher stability). ISQ numerical values are generated by applying resonance frequency analysis (RFA) or sound waves through a specialized peg attached to the implant. Data were combined to reduce the number of intervals for analysis purposes. Data from intervals were combined as follows:
Tr0 = T0 (baseline) Tr1 = Average of follow-up week 1 (T1) and follow-up week 2 (T2) Tr2 = Average of follow-up week 3 (T3) and follow-up week 4 (T4) Tr3 = Average of follow-up week 5 (T5) and follow-up week 6 (T6) Tr4 = Average of follow-up week 7 (T7) and follow-up week 8 (T8)"|Baseline (T0) and weekly thereafter for 8 weeks (T1-T8)|Seven participants, each missing at least two posterior teeth in the same arch, were enrolled, resulting in 10 matched pairs for analysis. Outcome was assessed per implant, not per individual participant;||units on a scale|implants|Standard Deviation|Mean
634782|NCT02701296|Secondary|Sensation in the Peroneal Nerve Distribution|Self reported on a 3-point scale; 0=normal (No Sensory Block), 1= absent cold perception but touch sensation in tact (Partial Sensory Block), 2= absence of touch sensation (Complete Sensory Block)|Upon emergence from anesthesia in the PACU|||Participants|||Count of Participants
634783|NCT02701296|Secondary|Dorsiflexion in the Peroneal Nerve Distribution|Blinded nurse assessment on a 3-point scale 0= normal (No Motor Block), 1= weak (Partial Motor Block), 2 = absent (Complete Motor Block)|Upon emergence from anesthesia in the PACU|||Participants|||Count of Participants
634784|NCT02701296|Secondary|Cold Sensation in the Tibial Nerve Distribution|Self reported on a 3-point scale; 0=normal (No Sensory Block), 1= absent cold perception but touch sensation in tact (Partial Sensory Block), 2= absence of touch sensation (Complete Sensory Block)|Upon emergence from anesthesia in the PACU|||Participants|||Count of Participants
635099|NCT02662387|Secondary|Time Between Admission to Pediatric ICU to Discharge From Pediatric ICU|Actual length of stay in pediatric ICU from admission to discharge|From subject enrollment to hospital discharge, not >170 hr|||hours||Full Range|Median
634789|NCT02701270|Primary|Assessment of IAUC (Incremental Area Under the Curve) in Blood Glucose Response||0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 minutes post dose|Participants from whom full set of blood glucose measurements were available.||min*mmol/L||Standard Deviation|Mean
634790|NCT02699892|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Good Response|Clinical response was assessed according to EULAR categorical DAS28 response criteria, which defined clinically meaningful improvement at Weeks 24, 48, and 72. EULAR response was based on change from baseline (CFB) in DAS28 score and on actual DAS28 score, at Weeks 24, 48, and 72. DAS28 score: participant’s disease activity calculated using TJC28, SJC28, PGH [VAS: 0=no disease activity to 100=maximum disease activity] and ESR. DAS28 was calculated by following formula: (0.56*√TJC)+(0.28*√SJC)+(0.70*ln ESR)+(0.014*PGH). Total possible score = 0-10, higher scores represented higher disease activity. EULAR Good response: DAS28</=3.2; reduction of DAS28 >1.2.|Baseline, Weeks 24, 48 and 72|"ITT Population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified those participants who were evaluable for a specified time point."||Percentage of participants|||Number
634791|NCT02699892|Primary|Percentage of Participants Achieving Reduction From Baseline in Disease Activity Score Based on 28 Joints Count (DAS28) of More Than 1.2 Units After 24 Weeks of First Rituximab Infusion|DAS28 score is a measure of participant’s disease activity calculated using tender joint count [28 joints] (TJC28), swollen joint count [28 joints] (SJC28), participant’s global assessment of disease activity (PGH) [visual analog scale (VAS): 0=no disease activity to 100=maximum disease activity] and erythrocyte sedimentation rate (ESR). DAS28 was calculated according to following formula: [0.56 multiplied by (*) square root (√) of TJC] plus (+) [0.28*√SJC]+[0.70*the natural logarithm (ln) ESR]+[0.014*PGH]. Total possible score of 0 to approximately 10, where higher scores represented higher disease activity. Scores below 2.6 indicated clinical remission, score of less than or equals to (</=) 3.2 indicated low disease activity, score of greater than (>) 3.2 to </=5.1 indicated moderate disease activity, scores above 5.1 indicated high or severe disease.|Baseline, 24 weeks after first rituximab infusion (Week 24)|"ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome."||Percentage of participants|||Number
634792|NCT02699684|Secondary|Change From Insertion in Minimum Protected Area (MPA)|MPA (the minimum area of the contact lens surface (expressed in %) protected by the tear film between two natural blinks) was assessed by the Investigator during the interblink period using the Tearscope® lighting system. Higher values indicate a more stable tear film in front of the lens. This Outcome Measure was pre-specified for AOHG only. Both eyes contributed to the analysis.|Hour 0 (Lens Insertion) to Hour 12 on Day 1|Full Analysis Set. Number Analyzed is the number of eyes with non-missing response.||percentage of contact lens surface area|Eyes|Standard Deviation|Mean
634793|NCT02699684|Secondary|Mean Ex Vivo Total Cholesterol Uptake After 30 Days of Wear|The contact lens was removed from the eye. Cholesterol deposits were extracted and measured in micrograms (μg) per lens. Lower deposits indicate increased lens performance. Only one eye (right eye) contributed to the analysis.|Day 30, each product|Full Analysis Set. Only the right (OD) lenses were collected from a subset of subjects.||μg||Standard Deviation|Mean
634794|NCT02699684|Primary|Percentage of Subjects Satisfying the “no Re-fit” Criteria in Both Eyes|Overall lens fit was graded by the Investigator on a 5-point scale: -2 (unacceptably tight); -1 (acceptably tight); 0 (optimal fit); +1 (acceptable loose); +2 (unacceptable loose). 'No re-fit' criteria was satisfied if an acceptable or optimal overall lens fit, that was also within one grade of the habitual lens fit value, was achieved.|Day 30, each product|Full Analysis Set. Number Analyzed is the number of subjects with non-missing response.||percentage of subjects|||Number
634795|NCT02699593|Primary|Visual Acuity (LogMAR)|Distance Visual Acuity (LogMAR) was assessed using an ETDRS chart at the 2-week follow-up for each subject and eye for 2 conditions, Bright low contrast and Dim high contrast. The average visual acuity (LogMAR) for each condition and lens was reported.|2-week Follow-up|Subjects that completed all study visits without a major protocol deviation.||LogMAR|Eyes|Standard Deviation|Mean
634796|NCT02699593|Primary|Contact Lens Wearing Time|Contact lens wearing time was collected for each subject at the 2-week follow-up evaluation. The average contact lens wearing time in hours was reported for each lens.|2-week follow-up|Subjects that completed all study visits without a major protocol deviation.||Hours||Standard Deviation|Mean
634797|NCT02698566|Primary|Percentage of PFS Usage Errors on Essential Tasks|Usage error was defined as user action or lack of user action while using the medical device that led to a different result than intended by the manufacturer or expected by the user. Essential tasks were those that were required in order to complete the use process for effective use of the product.|Day 1|Three HCP's referred to as 'participants' performed tasks on 35 enrolled patients by giving single PFS ITV injection to each patient. The percentages are calculated out of the total 35 PFS ITV injections administered.||percentage of usage errors|ITV injections||Number
634798|NCT02698566|Primary|Percentage of PFS Usage Errors on Safety Critical Tasks|Usage error was defined as user action or lack of user action while using the medical device that led to a different result than intended by the manufacturer or expected by the user. Safety critical tasks where those in which use error could have a reasonably foreseeable potential for clinical impact or harm.|Day 1|Three HCP's referred to as 'participants' performed tasks on 35 enrolled patients by giving single PFS ITV injection to each patient. The percentages are calculated out of the total 35 PFS ITV injections administered.||percentage of usage errors|ITV injections||Number
634799|NCT02698566|Primary|Percentage of Successful Task Completions|Product use tasks included sequence of steps starting from opening the carton, removing contents from carton to disposing of used PFS and needle. Tasks were considered to be successfully completed if the correct results were achieved without a use error, even if the instructions for use (IFU) were not followed exactly (example: not removing the needle cap prior to adjusting a dose). Usage error was defined as user action or lack of user action while using the medical device that led to a different result than intended by the manufacturer or expected by the user. The ability of HCPs to follow the IFU to prepare and administer a ranibizumab PFS ITV injection dose to patients was evaluated by successful task completion.|Day 1|Three HCPs referred to as 'participants' performed tasks on 35 enrolled patients by giving single PFS ITV injection to each patient. The percentages are calculated out of the total 35 PFS ITV injections administered.||percentage of tasks|ITV injections||Number
634800|NCT02698423|Secondary|Proportion of Women With a Positive HPV Self-test Who Underwent All the Recommended Follow-up Clinical Investigations.|Assess the compliance with further follow-up among HPV-positive women.|Up to 5 years||||||
634801|NCT02698423|Primary|Number of Participants Who Performed HPV Self-testing Compared to the Number of Participants Who Responded to the Invitation to Come to the Hospital for Pap Testing|Compare participation to cervical cancer screening for home-based HPV self-testing versus clinic-based Pap testing.|Up to 5 years|||Participants|||Count of Participants
634802|NCT02697890|Secondary|Keratinized Tissue Width (mm)|Assessed clinically by caliper/periodontal probe and radiographically by CBCT scans.|4 months after surgical procedure|||mm||Standard Deviation|Mean
634803|NCT02697890|Secondary|Changes in Soft Tissues|Clinical measurements will be recorded using the prefabricated stent and its horizontal and vertical reference holes along with a caliper.|4 months after surgical procedure|||mm||Standard Deviation|Mean
634804|NCT02697890|Secondary|Changes in Hard Tissues|Clinical measurements will be recorded using the prefabricated stent and its horizontal and vertical reference holes along with a caliper.|4 months after surgical procedure|||mm||Standard Deviation|Mean
634805|NCT02697890|Primary|Changes in Alveolar Bone (mm)|Width of Alveolar Bone at 4, 7, and 10mm heights apical to the CEJ buccally and lingually. Mean of overall buccal and lingual/palatal height (reference hole to buccal and lingual bone top).Assessed clinically by caliper/periodontal probe and radiographically by CBCT scans|4 months after surgical procedure|||mm||Standard Deviation|Mean
634810|NCT02695446|Secondary|Skin/Dermal Levels of Minocycline||Measured at 2 weeks in half the subjects, 4 week biopsies not performed per early stopping rules|||ng/ml||Full Range|Mean
634811|NCT02695446|Primary|Plasma Minocycline Level||Assessed at week 2 and week 4; reported at week 4|||ng/ml||Standard Deviation|Mean
634812|NCT02695290|Secondary|Time to First Dose Reduction of Afatinib Caused by Adverse Events (AEs)|Time to first dose reduction of afatinib caused by Adverse Events (AEs) defined as time from the date of the first administration of afatinib to the first dose reduction of afatinib caused by AEs.|Up to 98 days|All data collected from the single patient who received study medication. As none of the AEs led to the dose reduction hence time to first dose reduction is not applicable.|||||
634813|NCT02695290|Secondary|Percentage of Patients With Occurrence of CTCAE Grade 3 or Higher Diarrhoea, Rash/Acne+, Stomatitis+ and Paronychia+ (+ Represents Grouped Term)|Percentage of patients with occurrence of Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or higher diarrhoea, rash/acne+, stomatitis+ and paronychia+ (+ represents grouped term).|Up to 98 days|Patients who receive at least one dose of afatinib will be included in the treated set.All data collected from the single patient who received study medication. All data collected from the single patient who received study medication.||Percentage of Participants|||Number
634814|NCT02695290|Primary|Percentage of Patients With Occurrence of Adverse Events (AEs) Leading to Dose Reduction of Afatinib|Percentage of patients with occurrence of Adverse Events (AEs) leading to dose reduction of afatinib.|Up to 98 days|Patients who receive at least one dose of afatinib will be included in the treated set.All data collected from the single patient who received study medication.||Pecentage of Participants||95% Confidence Interval|Number
634843|NCT02691507|Secondary|Participant Questionnaire 7 Days After Treatment – Degree of Sleep|"Questions were answered seven days after treatment by the participant. The question is Thinking about how well you slept when using this product, would you say your sleep was?"|7 days after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
635616|NCT02614222|Secondary|Clinician Rating of the Device|Clinician rates the device on a scale of 1-10. This also includes a questionnaire.|Immediately following intervention (within 2 hours)|Data for this outcome measure was not collected|||||
634815|NCT02694718|Secondary|Number of Participants With Any Adverse Events and Serious Adverse Events|An adverse event (AE) is defined as any untoward medical occurrence in participants or clinical investigation participants administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.|Up to Week 16|Safety population included all the participants who received at least one dose of any of the study treatments and who had a baseline assessment.||Participants|||Number
634816|NCT02694718|Secondary|Percentage of Participants With Pathological Incomplete Tumor Response|Pathological incomplete tumor response was defined as grade 1 or 2 in the histological grading of regression according to Dworak grading of regression. Pathological incomplete tumor response rate, Grade 1: dominant tumor mass with obvious fibrosis and/or vasculopathy; Grade 2: dominantly fibrotic changes with few tumor cells or groups (easy to find) were assessed.|Up to Week 16|ITT population included all participants, who received at least one dose of study medication.||Percentage of participants||95% Confidence Interval|Number
634817|NCT02694718|Secondary|Percentage of Participants With Downstaging of Primary Tumor and/or Lymph Nodes|Downstaging of primary tumor (T) and/or lymph nodes (N) was defined as decrease by 1 point in T-value and/or N-value (comparing at screening and after treatment). It was assessed by colonoscopy, pathology, endosonography of rectum, chest X-ray, abdominopelvic Computed Tomography and Magnetic Resonance Imaging. Staging for tumor are: TX (primary tumor cannot be assessed), T0 (no evidence of primary tumor), Tis (carcinoma in situ), T1 (tumor invades submucosa), T2 (tumor invades muscularis propria), T3 (tumor invades through muscularis propria into subserosa/into non-peritonealized pericolic/perirectal tissues, T4 (tumor directly invades other organs or structures). Staging for lymph nodes are: NX (regional lymph nodes cannot be assessed), N0 (no regional lymph node metastasis), N1 (metastasis in 1 to 3 regional lymph nodes), N2 (metastasis in 4 or more regional lymph nodes).|From screening to Week 16|ITT population included all participants, who received at least one dose of study drug.||Percentage of participants|||Number
634818|NCT02694718|Secondary|Percentage of Participants With Resection (R0) in Participants With T4 Rectal Cancer|R0 resection was defined as complete resection of the tumor with adequate tumor-free margins and regional lymph node extirpation as confirmed by pathology after pre-operative chemotherapy plus capecitabine + oxaliplatin therapy.|Up to Week 16|The ITT consists of all included participants, who received at least one dose of study drug. Five participants from ITT population with T4 rectal cancer underwent surgery.||Percentage of participants|||Number
634819|NCT02694718|Secondary|Number of Participants With Marked Laboratory Abnormalities|Number of participants with marked laboratory abnormalities is reported.|Up to Week 16|Safety population included all the participants who received at least one dose of any of the study treatments and who had a baseline assessment.||Participants|||Number
634820|NCT02694718|Secondary|Percentage of Participants With Sphincter-preservation|Percentage of participants with sphincter-preservation is reported.|Up to Week 16|ITT population included all participants, who received at least one dose of study drug. Two participants from the ITT population did not undergo surgery (one died, one withdrew consent).||Percentage of participants|||Number
634821|NCT02694718|Primary|Percentage of Participants With Pathological Complete Tumor Response|Pathological complete tumor response was defined as grade 3 or 4 in the histological grading of regression according to Dworak classification. Grade 0 is no regression; Grade 1 is dominant tumor mass with obvious fibrosis and/or vasculopathy; Grade 2 is dominantly fibrotic changes with few tumor cells or groups; Grade 3 is defined as very few (difficult to find microscopically) tumor cells in fibrotic tissue with or without mucous substance; Grade 4 is defined as no tumor cells, only fibrotic mass (total regression or response).|Up to Week 16|The intent to treat (ITT) population included all participants, who received at least one dose of study drug.||Percentage of participants||95% Confidence Interval|Number
634822|NCT02694536|Secondary|Progression-Free Survival (PFS) According to RECIST|Tumor assessments were performed using RECIST. PFS was defined as the time from treatment start to the time of death or disease progression. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to smallest sum of LD on study. PFS was estimated by Kaplan-Meier methodology and expressed in months.|Up to approximately 40 months (assessed at Baseline, every 8 weeks during treatment, and end of study)|"Safety Population. The Number of Participants Analyzed reflects the number of participants who contributed to the endpoint."||months||95% Confidence Interval|Median
634823|NCT02694536|Secondary|Percentage of Participants With Death or Disease Progression According to Response Evaluation Criteria in Solid Tumors (RECIST)|Tumor assessments were performed using RECIST. Disease progression was defined as greater than or equal to (≥) 20 percent (%) increase in sum of longest diameters (LD) of target lesions in reference to smallest sum of LD on study. The percentage of participants who died or demonstrated disease progression was reported to the nearest integer.|Up to approximately 40 months (assessed at Baseline, every 8 weeks during treatment, and end of study)|"Safety Population. The Number of Participants Analyzed reflects the number of participants who contributed to the endpoint."||percentage of participants|||Number
634824|NCT02694536|Secondary|Overall Survival (OS)|OS was defined as the time from start of treatment to time of death from any cause. Participants who had not died at the time of final analysis were censored at the date of last contact. OS was estimated by Kaplan-Meier methodology and expressed in months.|Up to approximately 40 months (assessed continuously through end of study)|"Safety Population. The Number of Participants Analyzed reflects the number of participants who contributed to the endpoint."||months||95% Confidence Interval|Median
634825|NCT02694536|Secondary|Percentage of Participants Who Died|The percentage of participants who died from any cause was reported to the nearest integer.|Up to approximately 40 months (assessed continuously through end of study)|"Safety Population. The Number of Participants Analyzed reflects the number of participants who contributed to the endpoint."||percentage of participants|||Number
634844|NCT02691507|Secondary|Participant Questionnaire 7 Days After Treatment - Skin on Waking|"Questions were answered seven days after treatment by the participant. The question is Thinking about your experience when using this product, how would you describe your skin upon awakening?"|Seven days after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
639806|NCT02371759|Primary|Baseline Electrocardiogram||baseline, 0 minutes|||Participants|||Count of Participants
634826|NCT02694536|Secondary|European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Item Scores|"The QLQ-C30 is a 30-item questionnaire that assesses physical (Questions 1-5), role (Questions 6-7), emotional (Questions 21-24), cognitive (Questions 20 and 25), and social (Questions 26-27) functional domains as well as global health status (Questions 29-30) and several symptoms including fatigue (Questions 10, 12, and 18), pain (Questions 9 and 19), nausea/vomiting (Questions 14-15), dyspnea (Question 8), appetite loss (Question 13), insomnia (Question 11), constipation/diarrhea (Questions 16-17), and financial difficulties (Question 28). Questions 1 to 28 were assessed on a 4-point scale from 1 (no/not at all) to 4 (very much) where higher scores represented worse symptoms. Questions 29 and 30 were assessed on a 7-point scale from 1 (very poor) to 7 (excellent) where higher scores represented better functioning. Item scores over the study period were averaged among all participants across all visits for which data were available."|Up to approximately 40 months (assessed at Baseline, every 4 weeks during treatment, and end of study)|"Safety Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of responses for each questionnaire item combined across all assessments (n) is shown in the table."||units on a scale||Standard Deviation|Mean
634827|NCT02694536|Primary|Percentage of Participants With Adverse Events (AEs)|An AE was defined as any untoward medical occurrence and which did not necessarily have a causal relationship with treatment. The percentage of participants who experienced at least 1 AE was reported.|Up to approximately 40 months (assessed continuously during treatment)|Safety Population||percentage of participants|||Number
634828|NCT02694315|Primary|Bishop Score Prior to Induction of Labor|"median Bishop score assessed by digital vaginal examination as follows:
Cervical dilatation in centimeters will be given a score of zero if closed, a score of 1 if 1-2 cm dilated, a score of 2 if 3-4 cm dilated and a score of 3 if 5 cm or more dilataion.
Effacement of the cervix will be given a score of zero if 0-30%, a score of 1 if 40-50%, a score of 2 if 60-70% and a score of 3 if 80% or more.
Station of fetal head will be given a score of zero if -3, a score of 1 if -2, a score of 2 if -1 to zero and a score of 3 if 1 or more.
Consistency of the cervix will be given a score of zero if firm, a score of 1 if medium and a score of 2 if soft.
Position of the cervix will be given a score of zero if posterior, a score of 1 if mid position and a score of 2 if anterior. So, a total score (sum of all scores) of zero at a minimum to 10 at a maximum can be estimated.
Note that a score more than 10 means patient is in labor not needing induction of labor."|72 hours|||units on a scale||Inter-Quartile Range|Median
634829|NCT02694315|Primary|Cervical Length Prior to Labor Induction|median cervical length measured by transvaginal ultrasound in centimetres|24 hours|||centimetres||Inter-Quartile Range|Median
634830|NCT02694198|Primary|Relation of Cervicovaginal Fetal Fibronectin Level to Duration of Induction of Abortion|Difference between women who expulsed the fetus within 24 hours and women who expulsed the fetus in more than 24 hours as regarding cervicovaginal fetal fibronectin level (ng/ml)|72 hours|||nanogram per milliliter||Standard Deviation|Mean
634831|NCT02694198|Primary|Cervicovaginal Fetal Fibronectin Level|mean cervicovaginal fetal fibronectin level in women undergoing midtrimesteric induction of abortion|72 hours|Depending on Francesco et al., 2005 who found that Fetal fibronectin test positive in 19 among 270 (7.0%) women undergoing mid-trimester abortion. Assuming α=0.05 and confidence interval (CI)= 10.0% and by using PASS 11th release the minimal sample size is 120. With a possible 10% drop out of cases, the enrolled cases would be 135 cases.||nanogram per milliliter||Standard Deviation|Mean
634832|NCT02693704|Primary|Listener's Subjective Preference|Listeners compare two audiovisual stimuli (diotic and spatialized) and Indicate their preference between binaural diotic (no spatialization), spatialized stimuli, or no preference. Results are given as the percentage of participant for the 3 possible answers in each group.|1 day of the experiment|||Percentage of participants|||Number
634833|NCT02693704|Primary|Speaker's Localization|"Localization error (in number of spatial sectors)
For each group: average localization error over all subjects in the group. It is the difference between the actual spatial sector and the one reported by the listeners. There were 5 spatial sectors, and 9 possible locations. For instance: if the stimuli is played in sector 4, and the listener perceives it in 2, then the localization error is |4-2| = 2. The goal is to compare the localization error in 3 conditions: 1/ with no hearing aids (reference of natural localization) and no spatialization 2/ with hearing aids and standard fittings and no spatialization, and 3/ with spatialization applied."|1 day of the experiment|||Localization error (# spatial sectors)||Standard Deviation|Mean
634834|NCT02693704|Primary|Speech Intelligibility|Speech recognition score (%) For each group: average of the SRS over all subjects in the group. The SRS correspond to the number of understood words in a sequence of sentences (French HINT database) mixed with several level of masking noise (speech-shaped noise). Some are played diotically, the other are spatialized in various directions. The goal is to ensure that the spatialization processing does not degrade the understanding of the speech.|1 day of the experiment|||Percentage of understood word||Standard Deviation|Mean
634835|NCT02692859|Secondary|the Anti-PRP Geometric Mean Fold Increase (GMFI)||28 days after full course of vaccination||||||
634836|NCT02692859|Secondary|the Anti-PRP Geometric Mean Concentrations (GMCs)||28 days after full course of vaccination||||||
634837|NCT02692859|Secondary|Proportion of Vaccinees With Anti-polyribosylribitol Phosphate (PRP) Concentrations ≥0.15μg/ml||28 days after full course of vaccination||||||
634838|NCT02692859|Secondary|Incidence of Serious Adverse Event (SAE) During the Whole Study Period||0-84 days for children aged 3-5 months, 0-56 days for children aged 6-11 months and 0-28 days for children aged 1-5 y||||||
634839|NCT02692859|Secondary|Incidence of Unsolicited Adverse Reactions||0-28 days after each dose||||||
634840|NCT02692859|Primary|Proportion of Vaccinees With Anti-polyribosylribitol Phosphate (PRP) Concentrations ≥1.0μg/ml||28 days after full course of vaccination||12/2017||||
634841|NCT02692859|Primary|Number of Participants With Solicited Adverse Reactions|Number of Participants with Solicited Adverse Reactions|0-7 days after each dose|A total of participants in aged 3-5 months,6-11months and 1-5years||Count of Participants|||Number
634842|NCT02691507|Secondary|Participant Questionnaire 7 Days After Treatment - Degree of Comfortableness Showing Skin|"Questions were answered seven days after treatment by the participant. The question is Thinking about how comfortable you felt showing your skin while using this product, would you say that you were"|Seven days after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
634845|NCT02691507|Secondary|Participant Questionnaire 7 Days After Treatment - Degree of Distraction by Itchy Eczema Skin|"Questions were answered seven days after treatment by the participant. The question is Thinking about your experience while using this product, please describe your degree of being distracted by your itchy, eczema skin. Would you say you were"|Seven days after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
634846|NCT02691507|Secondary|Participant Questionnaire 7 Days After Treatment - Skin Feels Smooth|"Questions were answered seven days after treatment by the participant. The question is This product leaves my skin feeling smooth"|Seven days after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
634847|NCT02691507|Secondary|Participant Questionnaire 7 Days After Treatment - Slept Better|"Questions were answered seven days after treatment by the participant. The question is I slept better due to less itching or skin discomfort"|Seven days after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
634848|NCT02691507|Secondary|Participant Questionnaire 7 Days After Treatment - Moisturized All Day|"Questions were answered seven days after treatment by the participant. The question is This product leaves my skin feeling moisturized all day"|Seven days after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
634849|NCT02691507|Secondary|Participant Questionnaire 7 Days After Treatment - Skin Feels Soft|"Questions were answered seven days after treatment by the participant. The question is This product makes my skin feel soft"|Seven days after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
634850|NCT02691507|Secondary|Participant Questionnaire 7 Days After Treatment - Product Does Not Rub Off on Sheets|"Questions were answered seven days after treatment by the participant. The question is This product does not rub off on sheets"|Seven days after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
634851|NCT02691507|Secondary|Participant Questionnaire 7 Days After Treatment - Skin Feels Touchable|"Questions were answered seven days after treatment by the participant. The question is This product makes my skin feel touchable"|Seven days after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
634852|NCT02691507|Secondary|Participant Questionnaire 7 Days After Treatment - Skin Feels Moisturized|"Questions were answered seven days after treatment by the participant. The question is This product leaves my skin feeling moisturized"|Seven days after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
634853|NCT02691507|Secondary|Participant Questionnaire 7 Days After Treatment - Shield for Skin|"Questions were answered seven days after treatment by the participant. The question is This product feels like a shield for my skin"|Seven days after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
634854|NCT02691507|Secondary|Participant Questionnaire 7 Days After Treatment - Long Lasting Moisture|"Questions were answered seven days after treatment by the participant. The question is This product provides long lasting moisture to my skin"|Seven days after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
634855|NCT02691507|Secondary|Participant Questionnaire 7 Days After Treatment - Comfortable Showing Skin|"Questions were answered seven days after treatment by the participant. The question is I feel comfortable showing my skin"|Seven days after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
634856|NCT02691507|Secondary|Participant Questionnaire 7 Days After Treatment - Calmer Skin on Waking|"Questions were answered seven days after treatment by the participant. The question is I wake up to calmer skin"|Seven days after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
634857|NCT02691507|Secondary|Participant Questionnaire 7 Days After Treatment - Distracted by Itchy Skin|"Questions were answered seven days after treatment by the participant. The question is I'm less distracted by my itchy skin"|Seven days after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
634858|NCT02691507|Secondary|Participant Questionnaire 7 Days After Treatment - Skin Feels Calm|"Questions were answered seven days after treatment by the participant. The question is This product calms my skin"|Seven days after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
634859|NCT02691507|Secondary|Participant Questionnaire 6 Hours After Treatment - Degree of Comfortableness Showing Skin|"Questions were answered six hours after treatment by the participant. The question is Thinking about how comfortable you felt showing your skin after using this product, would you say that you were"|Six hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
634860|NCT02691507|Secondary|Participant Questionnaire 6 Hours After Treatment - Degree of Distraction by Itchy Eczema Skin|"Questions were answered six hours after treatment by the participant. The question is Thinking about your experience after using this product, please describe your degree of being distracted by your itchy, eczema skin. Would you say you were"|Six hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
634861|NCT02691507|Secondary|Participant Questionnaire 6 Hours After Treatment - Skin Feels Smooth|"Questions were answered six hours after treatment by the participant. The question is This product leaves my skin feeling smooth"|Six hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
634862|NCT02691507|Secondary|Participant Questionnaire 6 Hours After Treatment - Skin Feels Soft|"Questions were answered six hours after treatment by the participant. The question is This product makes my skin feel soft"|Six hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
634863|NCT02691507|Secondary|Participant Questionnaire 6 Hours After Treatment - Skin Feels Touchable|"Questions were answered six hours after treatment by the participant. The question is This product makes my skin feel touchable"|Six hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
634864|NCT02691507|Secondary|Participant Questionnaire 6 Hours After Treatment - Skin Feels Moisturized|"Questions were answered six hours after treatment by the participant. The question is This product leaves my skin feeling moisturized"|Six hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
634865|NCT02691507|Secondary|Participant Questionnaire 6 Hours After Treatment - Shield for Skin|"Questions were answered six hours after treatment by the participant. The question is This product feels like a shield for my skin"|Six hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
634866|NCT02691507|Secondary|Participant Questionnaire 6 Hours After Treatment - Comfortable Showing Skin|"Questions were answered six hours after treatment by the participant. The question is I feel comfortable showing my skin"|Six hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
634867|NCT02691507|Secondary|Participant Questionnaire 6 Hours After Treatment - Distracted by Itchy Skin|"Questions were answered six hours after treatment by the participant. The question is I'm less distracted by my itchy skin"|Six hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
634868|NCT02691507|Secondary|Participant Questionnaire 6 Hours After Treatment - Calms Skin|"Questions were answered six hours after treatment by the participant. The question is This product calms my skin"|Six hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
634869|NCT02691507|Secondary|Participant Questionnaire 6 Hours After Treatment - Long Lasting Moisture|"Questions were answered six hours after treatment by the participant. The question is This product provides long lasting moisture"|Six hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
634870|NCT02691507|Secondary|Participant Questionnaire 5 Hours After Treatment - Skin Feeling Soft|"Questions were answered five hours after treatment by the participant. The question is This product leaves my skin feeling soft"|Five hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
634871|NCT02691507|Secondary|Participant Questionnaire 5 Hours After Treatment - Long Lasting Moisture|"Questions were answered five hours after treatment by the participant. The question is This product provides long lasting moisture"|Five hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
634872|NCT02691507|Secondary|Participant Questionnaire 4 Hours After Treatment - Skin Feeling Soft|"Questions were answered four hours after treatment by the participant. The question is This product leaves my skin feeling soft"|Four hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
634873|NCT02691507|Secondary|Participant Questionnaire 4 Hours After Treatment - Long Lasting Moisture|"Questions were answered four hours after treatment by the participant. The question is This product provides long lasting moisture"|Four hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
634874|NCT02691507|Secondary|Participant Questionnaire Immediately After Treatment - Product Does Not Sting|"Questions were answered immediately after treatment by the participant. The question is This product does not sting when applied"|0 Days - Immediately after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
634875|NCT02691507|Secondary|Participant Questionnaire Immediately After Treatment - Moisturized Skin|"Questions were answered immediately after treatment by the participant. The question is This product leaves my skin feeling immediately moisturized"|0 Days - Immediately after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
634876|NCT02691507|Secondary|Participant Questionnaire Immediately After Treatment - Calm Skin|"Questions were answered immediately after treatment by the participant. The question is This product calms my skin"|0 Days - Immediately after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
634877|NCT02691507|Secondary|Participant Questionnaire Immediately After Treatment - Product Fast Absorbing|"Questions were answered immediately after treatment by the participant. The question is This product is fast absorbing"|0 Days - Immediately after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
634878|NCT02691507|Secondary|Participant Questionnaire on Day 0 Pre-treatment – Comfortable Showing Skin Over Past 2 Days|"Questions were answered before treatment by the participant. The question is Thinking about how comfortable you felt showing your skin during the last two days, would you say that you were"|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
634879|NCT02691507|Secondary|Participant Questionnaire on Day 0 Pre-treatment – Sleep During Past 2 Days|"Questions were answered before treatment by the participant. The question is Thinking about how well you slept during the past two days, would you say your sleep was?"|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
634880|NCT02691507|Secondary|Participant Questionnaire on Day 0 Pre-treatment – Skin Upon Waking Over Past 2 Days|"Questions were answered before treatment by the participant. The question is Thinking about your experience over the past two days, how would you describe your skin upon awakening?"|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
678519|NCT01596842|Secondary|Hemoglobin Levels at 12 Weeks||12 weeks|||g/dL||Standard Deviation|Mean
634881|NCT02691507|Secondary|Participant Questionnaire on Day 0 Pre-treatment – Distracted by Itchy Eczema Skin Over Past 2 Days|"Questions were answered before treatment by the participant. The question is Thinking about your experience over the past two days, please describe your degree of being distracted by your itchy, eczema skin. Would you say you were"|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
634882|NCT02691507|Secondary|Participant Questionnaire on Day 0 Pre-treatment – Soft Skin|"Questions were answered before treatment by the participant. The question is My skin feels soft"|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
634883|NCT02691507|Secondary|Participant Questionnaire on Day 0 Pre-treatment – Touchable Skin|"Questions were answered before treatment by the participant. The question is My skin feels touchable"|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
634884|NCT02691507|Secondary|Participant Questionnaire on Day 0 Pre-treatment – Moisturized Skin|"Questions were answered before treatment by the participant. The question is My skin feels moisturized"|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
634885|NCT02691507|Secondary|Participant Questionnaire on Day 0 Pre-treatment – Comfortable Showing Skin|"Questions were answered before treatment by the participant. The question is I feel comfortable showing my skin"|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
634886|NCT02691507|Secondary|Participant Questionnaire on Day 0 Pre-treatment – Smooth Skin|"Questions were answered before treatment by the participant. The question is My skin feels smooth"|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
634887|NCT02691507|Secondary|Participant Questionnaire on Day 0 Pre-treatment – Calmer Skin|"Questions were answered before treatment by the participant. The question is I wake up to calmer skin"|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
634888|NCT02691507|Secondary|Participant Questionnaire on Day 0 Pre-treatment – Distracted by Itchy Skin|"Questions were answered before treatment by the participant. The question is I'm less distracted by my itchy skin"|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
634889|NCT02691507|Secondary|Change From Baseline in Mean Corneometer Measurement 7 Days After Treatment|Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.|Baseline to seven days after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||arbitrary units||Standard Deviation|Mean
634890|NCT02691507|Secondary|Change From Baseline in Mean Corneometer Measurement 6 Hours After Treatment|Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.|Baseline to six hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||arbitrary units||Standard Deviation|Mean
634891|NCT02691507|Secondary|Change From Baseline in Mean Corneometer Measurement 5 Hours After Treatment|Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.|Baseline to five hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||arbitrary units||Standard Deviation|Mean
634892|NCT02691507|Secondary|Change From Baseline in Mean Corneometer Measurement 4 Hours After Treatment|Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.|Baseline to four hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||arbitrary units||Standard Deviation|Mean
634893|NCT02691507|Secondary|Change From Baseline in Mean Corneometer Measurement 3 Hours After Treatment|Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.|Baseline to three hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||arbitrary units||Standard Deviation|Mean
634894|NCT02691507|Secondary|Change From Baseline in Mean Corneometer Measurement 2 Hours After Treatment|Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.|Baseline to two hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||arbitrary units||Standard Deviation|Mean
634895|NCT02691507|Secondary|Change From Baseline in Mean Corneometer Measurement 1 Hour After Treatment|Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.|Baseline to one hour after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||arbitrary units||Standard Deviation|Mean
634940|NCT02684942|Other Pre-specified|Ovoids Size|Size of ovoids that a pair part of brachytherapy applicator insert in vagina trough cervix.|after complete applicator insertion.|Each patient was treated with 4 fractions of brachytherapy.||Centimeter|fraction|Full Range|Median
634896|NCT02691507|Secondary|Change From Baseline in Mean Corneometer Measurement Immediately Following Treatment|Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.|Baseline to Immediately following treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||arbitrary units||Standard Deviation|Mean
634897|NCT02691507|Primary|Change From Baseline in the Itch Assessment Score 7 Days After Treatment|The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.|Baseline to seven days after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||units on a scale||Standard Deviation|Mean
634898|NCT02691507|Primary|Change From Baseline in the Itch Assessment Score 6 Hours After Treatment|The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.|Baseline to six hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||units on a scale||Standard Deviation|Mean
634899|NCT02691507|Primary|Change From Baseline in the Itch Assessment Score 5 Hours After Treatment|The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.|Baseline to five hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||units on a scale||Standard Deviation|Mean
634900|NCT02691507|Primary|Change From Baseline in the Itch Assessment Score 4 Hours After Treatment|The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.|Baseline to four hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||units on a scale||Standard Deviation|Mean
634901|NCT02691507|Primary|Change From Baseline in the Itch Assessment Score 3 Hours After Treatment|The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.|Baseline to three hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||units on a scale||Standard Deviation|Mean
634902|NCT02691507|Primary|Change From Baseline in the Itch Assessment Score 2 Hours After Treatment|The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.|Baseline to two hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||units on a scale||Standard Deviation|Mean
634903|NCT02691507|Primary|Change From Baseline in the Itch Assessment Score 1 Hour After Treatment|The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.|Baseline to one hour after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||units on a scale||Standard Deviation|Mean
634904|NCT02691507|Primary|Change From Baseline in the Itch Assessment Score Immediately Following Treatment|The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.|Baseline to immediately following treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||units on a scale||Standard Deviation|Mean
634905|NCT02691416|Secondary|Montreal Cognitive Assessment (MoCA)|A questionnaires is used to assess the cognitive function of patients in clinical,the total range was 0-30,and 27-30 were considered as normal value,<27 were considered as recognitive dysfunction.|before induction,1,3,7days post surgery|||units on a scale||Standard Deviation|Mean
634906|NCT02691416|Secondary|Mini Mental State Examination (MMSE)|A questionnaires is used to assess the cognitive function of patients in clinical,the total range was 0-30,and 27-30 were considered as normal value,<27 were considered as recognitive dysfunction.|before induction,1,3,7days post surgery|||units on a scale||Standard Deviation|Mean
634907|NCT02691416|Primary|Evidences of Clinically Definite Oxidative Stress: Nucleoplasmic Bridges|Evidences of clinically definite oxidative stress: nucleoplasmic bridges confirmed by Cytokinesis-block Micronucleus Test|before induction,clamping removal ,operation ending,1,3,7days post surgery|||number of nucleoplasmic bridges/1000 BN||Standard Deviation|Mean
634908|NCT02691416|Primary|Evidences of Clinically Definite Oxidative Stress: Nuclear Buds|Evidences of clinically definite oxidative stress:nuclear buds Confirmed by Cytokinesis-block Micronucleus Test|before induction,clamping removal ,operation ending,1,3,7days post surgery|||number of nuclear buds/1000 BN cells||Standard Deviation|Mean
634909|NCT02691416|Primary|Evidences of Clinically Definite Oxidative Stress Confirmed by High Performance Liquid Chromatography|Evidences of clinically definite oxidative stress :α- tocopherol,γ- tocopherol which was used to assess the antioxidant defense.|before induction,after clamping removal ,operation ending ,1,3,7days post surgery|||ug/ml||Standard Deviation|Mean
634910|NCT02691416|Primary|Evidences of Clinically Definite Oxidative Stress:Micronuclei|Evidences of clinically definite oxidative stress:micronuclei confirmed by Cytokinesis-block Micronucleus Test|before induction,clamping removal ,operation ending,1,3,7days post surgery|||number of micronuclei/1000 BN cells||Standard Deviation|Mean
634911|NCT02691416|Primary|Evidences of Clinically Definite Oxidative Stress Confirmed by ELISA|Evidences of clinically definite oxidative stress:8-isoprostane,as a reliable biomarkers of lipid peroxidation|before induction, after clamping removal,operation ending,1,3,7days post surgery|||pg/ml||Standard Deviation|Mean
634912|NCT02691416|Primary|Evidences of Clinically Definite Oxidative Stress Confirmed by ELISA Kit|Evidences of clinically definite oxidative stress :Superoxide dismutase activity, Hydroxyl radical|before induction,after clamping removal ,operation ending ,1,3,7days post surgery|||U/ml||Standard Deviation|Mean
634913|NCT02691143|Secondary|Change in Numeric Pain Rating Scale (NPRS)|Subjects rate their pain on the Numeric Pain Rating Scale (NPRS), a scale from 0-10, 0 being none and 10 being the worst imaginable.|3 Testing sessions: (T1) Baseline, (T2) Immediate Post, and (T3) 24-48hours|||units on a scale||Full Range|Mean
635025|NCT02670473|Secondary|Overall Comfort|Subjective rating of overall comfort for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-10, 0=could feel, 10=cannot feel.|Baseline, 1 week, 2 weeks, and 4 weeks|||units on a scale||Standard Deviation|Mean
634914|NCT02691143|Primary|Change in Cervical Range of Motion|Six cervical ranges of motion values will be recorded utilizing the Acumar DataCapture hand-held dual inclinometer. Range of motion will be measured at maximum (max) degrees and average degrees of 6 trials and will include: flexion (F), extension (E), left side-bending (LSB), right side-bending (RSB), left rotation (LR), and right rotation (RR).|3 Testing sessions: (T1) Baseline, (T2) Immediate Post, and (T3) 24-48hours|||degrees||Full Range|Mean
634915|NCT02690727|Secondary|Pharmacokinetic Parameters|Peak Plasma Concentration (Cmax)|up to 24 hours post-dose.|Subjects who provided evaluable data for both treatments||nanogram per millilitre (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
634916|NCT02690727|Secondary|Number of Participants With Treatment-related AE|Adverse events as Adverse Events as Assessed by CTCAE v4.0|7 days||||||
634917|NCT02690727|Primary|Pharmacokinetic Parameters (Area Under the Plasma Concentration Versus Time Curve (AUC))|Pharmacokinetic parameters (Area under the plasma concentration versus time curve (AUC)) AUC0-T of RP6530 in fed and fast state.|up to 24 hours post-dose.|subjects who provided evaluable data for both treatments (Fasting and fed conditions)||nanogram*hour per millilitre (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
634918|NCT02689804|Secondary|Time to Maximum Concentration of Serum UPA|(Tmax) calculated in women with normal and obese BMI|Up to 24 hours|||h||Standard Deviation|Mean
634919|NCT02689804|Secondary|Time to Maximum Concentration of Serum LNG|(Tmax) calculated in women with normal and obese BMI|Up to 24 hours|||h||Standard Deviation|Mean
634920|NCT02689804|Secondary|Maximum Concentration of Serum UPA|(Cmax) calculated in women with normal and obese BMI|Up to 24 hours|||ng/mL||Inter-Quartile Range|Mean
634921|NCT02689804|Secondary|Maximum Concentration of Serum LNG|(Cmax) calculated in women with normal and obese BMI|Up to 24 hours|||ng/mL||Inter-Quartile Range|Mean
634922|NCT02689804|Secondary|Clearance of Serum UPA|(Cl) calculated in women with normal and obese BMI|Up to 24 hours|||L/h||Inter-Quartile Range|Mean
634923|NCT02689804|Secondary|Clearance of Serum LNG|(Cl) calculated in women with normal and obese BMI|Up to 24 hours|||L/h||Inter-Quartile Range|Mean
634924|NCT02689804|Secondary|Elimination Half-life of Serum UPA|(t1/2) calculated in women with normal and obese BMI|Up to 24 hours|Cross-over study: 16 normal-BMI and 16 obese-BMI enrolled and each participant received both drugs in random order.||h||Inter-Quartile Range|Mean
634925|NCT02689804|Secondary|Elimination Half-life of Serum LNG|(t1/2) calculated in women with normal and obese BMI|Up to 24 hours|Cross-over study: 16 normal-BMI and 16 obese-BMI enrolled and each participant received both drugs in random order.||h||Inter-Quartile Range|Mean
634926|NCT02689804|Primary|Area Under the Curve From Time 0 to 24 Hours of Serum UPA Concentration|UPA-EC PK parameter (AUC 0-24 h) in women with normal and obese BMI women.|Up to 24 hours|Cross-over study: 16 normal-BMI and 16 obese-BMI enrolled and each participant received both drugs in random order.||ng*h/mL||Inter-Quartile Range|Mean
634927|NCT02689804|Primary|Area Under the Curve From Time 0 to 24 Hours of Serum LNG Concentration|LNG-EC PK parameter (AUC 0-24 h) in women with normal and obese BMI women.|Up to 24 hours|Cross-over study: 16 normal-BMI and 16 obese-BMI enrolled and each participant received both drugs in random order.||ng*h/mL||Inter-Quartile Range|Mean
634928|NCT02687217|Secondary|Number of Patients Requiring Additional Treatment|Requirement of antipyretics; increased dose/ duration of antibiotic usage other than standard protocol; need for change to higher antibiotics; requirement of drainage procedures for pus/ wound infections; requirement for additional dressing sessions|14 days|||participants|||Number
634929|NCT02687217|Secondary|Number of Patients Requiring Additional Investigations|Sonography; Pus culture; blood culture; Total Leucocyte Count.|14 days|||participants|||Number
634930|NCT02687217|Primary|ASEPSIS Score|"ASEPSIS score- Additional treatment; Serous discharge; Erythema; Purulent exudate; Separation of deep tissues; Isolation of bacteria; and Stay. A daily score of 20 or more considered evidence of infection.
Category of infection:
Total score of 0–10 satisfactory healing; 11–20 disturbance of healing; 21–30 minor wound infection; 31–40 moderate wound infection; > 40 severe wound infection."|14 days|||participants|||Number
634931|NCT02687126|Other Pre-specified|Cross Sectional Area of Internal Jugular Vein|Correlation of cross sectional area of internal jugular vein with number of attempts, time taken for successful cannulation and complication rate|up to 1 hour before intervention|||Pearson's correlation Coefficient|||Number
634932|NCT02687126|Secondary|Number of Patients With Complications|Arterial puncture, Hemothorax, Pneumothorax, Local site hematoma|up to 24 hours after intervention|||Participants|||Count of Participants
634933|NCT02687126|Secondary|Time to Successful Cannulation|Time from skin prick to blood aspiration via the catheter immediately following the guide-wire removal|up to 1 hour after intervention|||Seconds||Standard Deviation|Mean
634934|NCT02687126|Primary|Number of Attempts for Successful Central Venous Cannulation|An attempt will be considered when complete withdrawal of the puncturing needle out of skin surface will occur|up to 24 hours after intervention|||Attempts||Standard Deviation|Mean
634937|NCT02684942|Other Pre-specified|Fentanyl Dose|Sum of fentanyl dose when finish each fraction of brachytherapy|after complete treatment.|Participants received 4 fraction of brachytherapy. Thus all 160 fractions separated to two group of drug and analysis data in each group.||ug.|fraction|Standard Deviation|Mean
634938|NCT02684942|Other Pre-specified|Meperidine Dose|Sum of meperidine dose when finish each fraction of brachytherapy|after complete treatment.|Participants received 4 fraction of brachytherapy. Thus all 160 fractions separated to two group of drug and analysis data in each group.||mg.|fraction|Standard Deviation|Mean
634939|NCT02684942|Other Pre-specified|Tumor Size|Size of tumor at cervix measured by the doctor before insert applicator.|Before insert applicator in each fraction of brachytherapy.|Participants received 4 fraction of brachytherapy. Thus all 160 fractions separated to two group of drug and analysis data in each group.||CM.|fraction|Standard Deviation|Mean
639807|NCT02371759|Primary|Ceart Rate at 35 Minutes|Heart rate 30 minutes after local anesthesia injection, 35 minutes after baseline measurement|35th minute|||beats per minute||Standard Deviation|Mean
634941|NCT02684942|Secondary|Quality of Life|Perceived Quality of life (EQ-5D) was assessed before the first brachytherpy and immediately after completion of each of the 4 brachytherapy fractions. The EQ-5D have 5 dimensions: mobility, self-care, usual activities, topics each content 3 responses: no problems, some problems, extreme problems.|From date of the first fraction of brachytherapy until date of the last fraction of brachytherapy,once a week for 4 weeks|Pain score in each fraction.||participants|fraction||Number
634942|NCT02684942|Primary|Pain Score|Perceived pain score according to standard 10-cm visual analog scales (VAS) was assessed before injection of medicine for every 15 minutes up to 120 minutes.The minimum and maximum scores were 0, 10. Score 0 means no pain, 1-3 mild pain, 4-6 moderate pain, 7-9 severe pain and 10 worst pain.|From date of the first fraction until date of the last fraction of brachytherapy, once a week for four weeks|||units on a scale|fraction|Standard Deviation|Mean
634943|NCT02684630|Primary|Donor Postprocedure Platelet Count Following Donation of Double Platelet Product|The primary endpoint for this study was the participant’s postprocedure platelet count after completing a double platelet collection. A procedure was considered a success if the participant’s postprocedure platelet count was ≥ 100,000 platelets/μL.|The blood draw to determine post procedure platelet count will occur ≥ 15 minutes after the end of apheresis|The Full Analysis Set (FAS) included all participants that completed the study and did not meet any of the protocol exclusion criteria. A participant could only have 1 product included in the FAS. The FAS was used to examine the primary and secondary endpoints.||Participants|||Count of Participants
634944|NCT02684630|Primary|Donor Postprocedure Platelet Count Following Donation of Single Platelet Product|The primary endpoint for this study was the postprocedure participant platelet count for participants who have completed a single or double platelet collection. A procedure was a success if the participant’s postprocedure platelet count was ≥ 100,000 platelets/μL. A procedure was a failure if the participant’s postprocedure platelet count was < 100,000 platelets/μL.|The blood draw to determine postprocedure platelet count will occur ≥ 15 minutes after the end of apheresis|The Full Analysis Set (FAS) included all participants that completed the study and did not meet any of the protocol exclusion criteria. A participant could only have 1 product included in the FAS. The FAS was used to examine the primary and secondary endpoints.||Participants|||Count of Participants
634945|NCT02684604|Primary|Quantitative Helicobacter Pylori IgG Assay in Serum|calculation of quantitative Helicobacter pylori IgG assay in serum|24 hours|||arbitrary unit per millilitre||Inter-Quartile Range|Median
634946|NCT02684396|Secondary|AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-648||Multiple time-points (up to 72 hours) post-dose|PK Analysis Set included all enrolled participants who had at least 1 measureable plasma concentration.||ng*hr/mL||Standard Deviation|Mean
634947|NCT02684396|Secondary|AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-648||Multiple time-points (up to 72 hours) post-dose|PK Analysis Set included all enrolled participants who had at least 1 measureable plasma concentration.||ng*hr/mL||Standard Deviation|Mean
634948|NCT02684396|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-648||Multiple time-points (up to 72 hours) post-dose|PK Analysis Set included all enrolled participants who had at least 1 measureable plasma concentration.||hours||Full Range|Median
634949|NCT02684396|Secondary|Cmax: Maximum Observed Plasma Concentration for TAK-648||Multiple time-points (up to 72 hours) post-dose|PK Analysis Set included all enrolled participants who had at least 1 measureable plasma concentration.||ng/mL||Standard Deviation|Mean
634950|NCT02684396|Primary|Percentage of Participants With at Least One Occurrence of Severe Hypoglycemia Post-dose|Severe hypoglycemia is defined as an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.|Day 1 to Day 4|Safety Analysis Set included all enrolled participants who received study drug.||percentage of participants|||Number
634951|NCT02684396|Primary|Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Signs Measurements at Least Once Post-dose|Vital signs will include body temperature (oral), sitting blood pressure (after the participant has rested for at least 5 minutes), respiration rate and pulse (bpm).|Day 1 to Day 4|Safety Analysis Set included all enrolled participants who received study drug.||percentage of participants|||Number
634952|NCT02684396|Primary|Percentage of Participants Who Meet the Markedly Abnormal Criteria, for Safety Laboratory Tests at Least Once Post-dose|The percentage of participants with any markedly abnormal standard safety laboratory values (chemistry, hematology and urinalysis) collected throughout study.|Day 1 to Day 4|Safety Analysis Set included all enrolled participants who received study drug.||percentage of participants|||Number
634953|NCT02684396|Primary|Percentage of Participants Who Have at Least One Treatment-Emergent Adverse Event (TEAE)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|Day 1 to Day 14|Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.||percentage of participants|||Number
634954|NCT02683954|Primary|Serum Nesfatin 1|"Venous samples for measurement of nesfatin-1 were taken by venipuncture from patients during the laparoscopy procedure immediately after initial evaluation and before any intervention.The blood samples were centrifuged immediately after their collection at 5000 rpm for 10 min and serum samples were stored at -20 °C until analysis. Nesfatin-1 was measured by Enzyme-Linked Immuno Sorbent Assay ELISA technique using commercially available kits (Boster Biological Technology Human Nesfatin-1 ELISA kits, Catalog number EK1138, USA) in the Central Labs of Ain Shams University Hospitals."|24 hours|In the endometriosis group, two patients were stage I, one was stage II, 12 were stage III and 15 were stage IV according to the revised ASRM scoring system. In the control group, 13 had polycystic varies, 11 had variable pelvic peritoneal adhesions, 4 had tubal block , one had unilateral ovarian cyst and one patient had atrophic ovaries.||picogram/millilitre||Inter-Quartile Range|Median
634955|NCT02682498|Secondary|Post-operative Complications|Examining the post-operative complication in comparison of standard knee injection post-operatively.|Up to 1 month|The vast majority of the patients had been discharged by 72 hours post-op, making this outcome low-powered and not useful. Because of this we used the 48 hour pain measurement.||complications|||Number
635617|NCT02614222|Primary|Time Needed to Correctly Identify the Neural Structure(s) and Induce the Peripheral Nerve Block||Immediately after intervention (within 2 hours)|||Minutes||Standard Deviation|Mean
634956|NCT02682498|Secondary|Average Daily Patient Pain Score|Examining the average daily patient pain score in comparison of standard knee injection post-operatively. The measure is the Visual-Analog-Scale (VAS) for subjective pain reporting. The minimum 0 (no pain) and the maximum is 10 (worst pain imagineable). There is only one measure in the scale (i.e. there are no subscales). Lower scores on the VAS scale equate to less pain and are therefore desirable.|Up to 48 hours|The vast majority of the patients had been discharged by 72 hours post-op, making this outcome low-powered and not useful. Because of this we used the 48 hour pain measurement.||Visual Analog Scale Rating||Inter-Quartile Range|Mean
634957|NCT02682498|Secondary|Average Daily Opioid Use During Admission|Opioid use will be monitored daily from the time of admission in comparison of standard knee injection post-operatively.|Up to 48 hours|The vast majority of the patients had been discharged by 72 hours post-op, making this outcome low-powered and not useful. Because of this we used the 48 hour pain measurement.||Total Morphine Equivalents||Inter-Quartile Range|Mean
634958|NCT02682498|Secondary|Recovery Room Opioid Use|Post anesthesia care unit (recovery room) opioid use in total mg morphine IV equivalent in comparison of standard knee injection post-operatively.|Up to 48 hours|The vast majority of the patients had been discharged by 72 hours post-op, making this outcome low-powered and not useful. Because of this we used the 48 hour pain measurement.||Total morphine equivalents||Inter-Quartile Range|Median
634959|NCT02682498|Primary|48 Hour Post-surgical Opioid Use|A comparison of group means between the control group and study group with regards to 48 hour opioid use.|48 hours|||morphine equivalents||Standard Deviation|Mean
634960|NCT02681458|Primary|The Prevalence of Superficial and Cutaneous Fungal Infections Among Drug and Non-Drug Users||up to two months|||participants|||Number
634961|NCT02679976|Primary|Intermediate Binocular LogMAR Visual Acuity|intermediate Binocular LogMAR Visual Acuity was measured at 67cm for Low luminance ( 2.5 CD/M^2 ), Medium luminance ( 50 CD/M^2 ) and High luminance ( 250 CD/M^2 )|4 Hr. Post Fitting|The analysis population includes all subjects that completed the study without a major protocol deviation.||-10*LogMAR||Standard Deviation|Mean
634962|NCT02679976|Primary|Near Binocular LogMAR Visual Acuity|Near Binocular LogMAR Visual Acuity was measured at 40cm for Low luminance ( 2.5 CD/M^2 ), Medium luminance ( 50 CD/M^2 ) and High luminance ( 250 CD/M^2 )|4 Hr. Post Fitting|The analysis population includes all subjects that completed the study without a major protocol deviation.||-10*LogMAR||Standard Deviation|Mean
634963|NCT02679976|Primary|Distance Binocular LogMAR Visual Acuity|Distance Binocular LogMAR Visual Acuity was measured at 4m for Low luminance ( 2.5 CD/M^2 ), Medium luminance ( 50 CD/M^2 ) and High luminance ( 250 CD/M^2 )|4 Hr. Post Fitting|The analysis population includes all subjects that completed the study without a major protocol deviation.||-10*LogMAR||Standard Deviation|Mean
634964|NCT02679469|Primary|Measure the Terminal-phase Elimination Half-life (T1/2)||pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose|||hours||Full Range|Median
634965|NCT02679469|Primary|Measure the Area Under the Concentration-time Curve From Time Zero to the Last Observable Concentration at Time t(AUCt)||pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose|||ng･h/mL||Standard Deviation|Mean
634966|NCT02679469|Primary|‎Measure the Maximum (Peak) Plasma Concentration of the Drug (Cmax)||pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose|||ng/mL||Standard Deviation|Mean
634967|NCT02678923|Secondary|Participants With Regression Of Coronary Atherosclerosis As Measured By A PAV Change <0|The number of participants with regression of coronary atherosclerosis is presented. For this Outcome Measure, the regression of coronary atherosclerosis is defined as a change in PAV from Baseline to Day 36 of less than zero.|Baseline through Day 36|mITT population included all participants who were screened, enrolled, randomized, received at least one infusion of study drug, and who had an evaluable Baseline and Follow-up IVUS assessment.||Participants|||Count of Participants
634968|NCT02678923|Secondary|Participants With Regression Of Coronary Atherosclerosis As Measured By A PAV Change Greater Than 2 Standard Deviations Of Test-Retest Measurement Variability|The number of participants with regression of coronary atherosclerosis is presented. For this Outcome Measure, the regression of coronary atherosclerosis is defined as a reduction in PAV from Baseline to Day 36 of greater than 2 standard deviations of the test-retest variability.|Baseline through Day 36|mITT population included all participants who were screened, enrolled, randomized, received at least one infusion of study drug, and who had an evaluable Baseline and Follow-up IVUS assessment.||participants|||Number
634969|NCT02678923|Secondary|Change From Baseline In TAV For The 10 Millimeters (mm) Subsegment With The Greatest Disease Burden At Day 36|Change in TAV from Baseline to Day 36 post-randomization of the most diseased 10-mm subsegment, as determined by IVUS. The change is calculated by subtracting the value at Baseline from the value at Day 36, with positive numbers to represent increases and negative numbers to represent decreases. Change in TAV was analyzed using an analysis of covariance (ANCOVA) model that included Baseline TAV for the most diseased 10-mm subsegment as a covariate and treatment group as factor. LS mean was adjusted for stratification factors of country and prior statin use.|Baseline, Day 36|mITT population included all participants who were screened, enrolled, randomized, received at least one infusion of study drug, and who had an evaluable Baseline and Follow-up IVUS assessment.||mm^3||Standard Error|Least Squares Mean
634970|NCT02678923|Secondary|Change From Baseline In Total Atheroma Volume (TAV) At Day 36|Change from Baseline to Day 36 post-randomization in normalized TAV in a targeted (imaged) coronary artery for all anatomically comparable slices, as determined by IVUS. The change is calculated by subtracting the value at Baseline from the value at Day 36, with positive numbers to represent increases and negative numbers to represent decreases. Change in TAV was analyzed using an analysis of covariance (ANCOVA) model that included Baseline TAV as a covariate and treatment group as factor. LS mean was adjusted for stratification factors of country and prior statin use.|Baseline, Day 36|mITT population included all participants who were screened, enrolled, randomized, received at least one infusion of study drug, and who had an evaluable Baseline and Follow-up IVUS assessment.||cubic millimeter (mm^3)||Standard Error|Least Squares Mean
635026|NCT02670473|Primary|Overall Fit Acceptance|Overall fit acceptance for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-4, 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimum acceptable, early review, 3=Not perfect but okay to dispense, 4=Perfect.|Baseline, 1 week, 2 weeks, and 4 weeks|||percentage of eyes|||Number
639808|NCT02371759|Primary|Heart Rate at 20 Minutes|Heart rate 15 minutes after local anesthesia injection, 20 minutes after baseline measurement|20th minute|||beats per minute||Standard Deviation|Mean
634971|NCT02678923|Primary|Change From Baseline In Percent Atheroma Volume (PAV) At Day 36|Change from Baseline to Day 36 post-randomization in PAV in a targeted (imaged) coronary artery for all anatomically comparable slices, as determined by IVUS. The change is calculated by subtracting the value at Baseline from the value at Day 36, with positive numbers to represent increases and negative numbers to represent decreases. Change in PAV was analyzed using an analysis of covariance (ANCOVA) model that included Baseline PAV as a covariate and treatment group as factor. Least Squares (LS) mean was adjusted for stratification factors of country and prior statin use.|Baseline, Day 36|mITT population included all participants who were screened, enrolled, randomized, received at least one infusion of study drug, and who had an evaluable Baseline and Follow-up IVUS assessment.||change in percent||Standard Error|Least Squares Mean
634972|NCT02678676|Secondary|Incidences With Malignancies|Percentage of participants with incidences of at least 1 malignancy was reported. All malignancies included adrenal, biliary, bladder, brain, breast, cervix, colon/rectal, gastric, hematological, hepatic, lung, mesothelioma, metastases, oesophageal, oropharyngeal, ovarian/uterine, pancreas, prostate, renal, skin and others.|Up to Year 10|The observational study population consisted of participants who enrolled in this study after completing the final visit of PROactive study (NCT00174993).||percentage of participants|||Number
634973|NCT02678676|Primary|Percentage of Participants With First Occurrence of Macro-vascular Event or Death|The composite macro-vascular event or death included all-cause mortality, non-fatal myocardial infarction, cardiac intervention, stroke, major leg amputation (above the ankle), bypass surgery or revascularization in the leg. The percentage of participants in the observational study population having first occurrence of macro-vascular event or death during the 10-year observational study period was analyzed. The data were analyzed using the Cox regression with respect to time to the first occurrence of macro-vascular event or death.|Up to Year 10|The observational study population consisted of participants who enrolled in this study after completing the final visit of PROactive study (NCT00174993).||percentage of participants|||Number
634974|NCT02678039|Secondary|Postoperative Pain Intensity Measured by Numeric Scale|Assessment of pain intensity by verbal report of patient on a digital scale of 0 (no pain) to 10 (worst pain).|3 months after surgery during follow up office visit with surgeon|Insufficient data were collected for this analysis|||||
634975|NCT02678039|Secondary|Postoperative Pain Intensity Measured by Numeric Scale|Assessment of pain intensity by verbal report of patient on a digital scale of 0 (no pain) to 10 (worst pain).|Measured at 48 hours after surgery|||milligrams||Standard Deviation|Mean
634976|NCT02678039|Secondary|Postoperative Pain Intensity Measured by Numeric Scale|Assessment of pain intensity by verbal report of patient on a digital scale of 0 (no pain) to 10 (worst pain).|Measured at 24 hours after surgery|||units on a scale of 0 to 10||Standard Deviation|Mean
634977|NCT02678039|Secondary|Incidence of Epidural Catheter Failure|Percent of epidural catheters that were correctly placed (percentage of catheters).|24 hours after surgery|||percentage of catheters|||Number
634978|NCT02678039|Primary|Intravenous Pain Medication|Outcome measure is mg of morphine equivalent used in first 24 hours after surgery: Postoperative pain medication use during the first 24 postoperative hours will be calculated by converting medication to an equivalent amount of morphine. This is an indirect measure of postoperative pain.|24 hours after surgery|||milligrams||Standard Deviation|Mean
634979|NCT02677779|Secondary|Bleeding: Proportion of Patients With Bleeding Necessitating Haemostasis|proportion of patients with bleeding necessitating haemostasis|during procedure|ITT analysis: patients with no detectable bacterial load at baseline were included.||participants|||Number
634980|NCT02677779|Secondary|Granulation: Percent of Ulcer Area Covered by Granulation.|Percent change of ulcer area covered by granulation from baseline to immediately after the end of procedure.|Baseline and immediately after procedure|ITT analysis: patients with no detectable bacterial load at baseline were included.||Percent change from baseline||Inter-Quartile Range|Median
634981|NCT02677779|Secondary|Fibrin: Percent of Ulcer Area Covered by Fibrin|Percent change of ulcer area covered by fibrin from baseline to immediately after the end of procedure|Baseline and immediately after the end of procedure|||Percent change from baseline||Inter-Quartile Range|Median
634982|NCT02677779|Secondary|Pain: Scores of Brief Pain Inventory|Scores of Brief Pain Inventory. Scale ranges: from 0 to 10. 0 = No pain; 10= Pain as bad as you can imagine.|During procedure.|ITT analysis: patients with no detectable bacterial load at baseline were included.||cm for a VAS scale.||Inter-Quartile Range|Median
634983|NCT02677779|Primary|Bacterial Load|Percent change in bacterial colonies from baseline.|Percent change in bacterial colonies from baseline. Variation from baseline and immediately after the end of procedure.|Per-protocol analysis: patients with no detectable bacterial load at baseline were excluded.||Percent change from baseline||Inter-Quartile Range|Median
634984|NCT02677493|Secondary|Geometric Mean Ratio as Measured by HI Antibody Titer Before (Day 0) and on Day 28 After Vaccination of the Investigational Product.||Day 28||||||
634985|NCT02677493|Secondary|Geometric Mean Titer as Measured by HI Antibody Titer Before (Day 0) and on Day 28 After Vaccination of the Investigational Product.||Day 28||||||
634986|NCT02677493|Secondary|Difference in Seroconversion Rate||Day 28||||||
634987|NCT02677493|Secondary|Geometric Mean Titer as Measured by HI Antibody Titer on Day 28 After Vaccination of the Investigational Product (GMTcomparator/GMTtest Vaccine).||Day 28||||||
634988|NCT02677493|Secondary|Rate of Healthy Adults Aged ≥19 ~ <65 Years and ≥65 Years With Seroprotection, Respectively.||Day 28||07/2017||||
634989|NCT02677493|Secondary|Rate of Healthy Adults Aged ≥19 ~ <65 Years and ≥65 Years With Seroconversion, Respectively.|Seroconversion is defined as follows. (Case 1) A pre-vaccination (Day 0) HI antibody titer < 1:10 and a post-vaccination (Day 28) HI antibody titer ≥ 1: 40. or (Case 2) a pre-vaccination (Day 0) HI antibody titer ≥ 1:10 and a minimum four-fold rise in post-vaccination (Day 28) HI antibody titer.|Day 28||07/2017||||
634990|NCT02677493|Primary|Rate of Healthy Adults Aged ≥19 Years With Seroprotection|Seroprotection: A post-vaccination (Day 28) HI antibody titer ≥ 1:40.|Day 28|The immunogenicity data obtained from the study subjects were analyzed primarily in the Per Protocol Set that was consists of subjects who had at least one dose of the investigational product and from whom post-treatment primary efficacy endpoint data, and have completed the study up to Visit 3 without a major protocol violation.||percentage of subjects||95% Confidence Interval|Number
639809|NCT02371759|Primary|Heart Rate at 15 Minutes|Heart rate 10 minutes after local anesthesia injection, 15 minutes after baseline measurement|15th minute|||beats per minute||Standard Deviation|Mean
634991|NCT02677493|Primary|Rate of Healthy Adults Aged ≥19 Years With Seroconversion|Seroconversion is defined as follows. (Case 1) A pre-vaccination (Day 0) HI antibody titer < 1:10 and a post-vaccination (Day 28) HI antibody titer ≥ 1: 40. or (Case 2) a pre-vaccination (Day 0) HI antibody titer ≥ 1:10 and a minimum four-fold rise in post-vaccination (Day 28) HI antibody titer.|Day 28|The immunogenicity data obtained from the study subjects were analyzed primarily in the Per Protocol Set that was consists of subjects who had at least one dose of the investigational product and from whom post-treatment primary efficacy endpoint data, and have completed the study up to Visit 3 without a major protocol violation.||percentage of subjects||95% Confidence Interval|Number
634992|NCT02675907|Secondary|Patient Global Assessment (PGA) of Pain Control at Hour 48|PGA of pain control was evaluated at Hour 24 and Hour 48 with subject reported degree of pain control over the preceding interval according to a 5 point scale (0-4) with categories of 0-poor, 1-fair, 2-good, 3-very good, or 4-excellent.|48 Hours|||Participants|||Count of Participants
634993|NCT02675907|Secondary|Patient Global Assessment (PGA) of Pain Control at Hour 24|PGA of pain control was evaluated at Hour 24 and Hour 48 with subject reported degree of pain control over the preceding interval according to a 5 point scale (0-4) with categories of 0-poor, 1-fair, 2-good, 3-very good, or 4-excellent.|24 Hours|||Participants|||Count of Participants
634994|NCT02675907|Secondary|Subjects With ≥ 50% Improvement in Pain From Baseline to Hour 24|Percent improvement in pain is the cumulative pain intensity percent reduction from baseline over the defined interval (6 or 24 hours), calculated as SPID for the defined interval (SPID6 or SPID24) divided by the baseline pain intensity (BaselinePI) extrapolated across that interval. Example: % Improvement through Hour 24 = 100 * SPID24 / (BaselinePI * 24 * 60), and SPID24 < 0 as an indication for improvement.|24 Hours|ITT Population||Participants|||Count of Participants
634995|NCT02675907|Secondary|Subjects With ≥ 50% Improvement in Pain From Baseline to Hour 6|Percent improvement in pain is the cumulative pain intensity percent reduction from baseline over the defined interval (6 or 24 hours), calculated as SPID for the defined interval (SPID6 or SPID24) divided by the baseline pain intensity (BaselinePI) extrapolated across that interval. Example: % Improvement through Hour 6 = 100 * SPID6 / (BaselinePI * 6 * 60), and SPID6 < 0 as an indication for improvement.|6 Hours|ITT Population||Participants|||Count of Participants
634996|NCT02675907|Secondary|Subjects With ≥ 30% Improvement in Pain From Baseline to Hour 24|Percent improvement in pain is the cumulative pain intensity percent reduction from baseline over the defined interval (6 or 24 hours), calculated as SPID for the defined interval (SPID6 or SPID24) divided by the baseline pain intensity (BaselinePI) extrapolated across that interval. Example: % Improvement through Hour 24 = 100 * SPID24 / (BaselinePI * 24 * 60), and SPID24 < 0 as an indication for improvement.|24 Hours|ITT Population||Participants|||Count of Participants
634997|NCT02675907|Secondary|Subjects With ≥ 30% Improvement in Pain From Baseline to Hour 6|Percent improvement in pain is the cumulative pain intensity percent reduction from baseline over the defined interval (6 or 24 hours), calculated as SPID for the defined interval (SPID6 or SPID24) divided by the baseline pain intensity (BaselinePI) extrapolated across that interval. Example: % Improvement through Hour 6 = 100 * SPID6 / (BaselinePI * 6 * 60), and SPID6 < 0 as an indication for improvement.|6 Hours|ITT Population||Participants|||Count of Participants
634998|NCT02675907|Secondary|Time to Meaningful Pain Relief (TTMPR)|Time to perceptible and meaningful pain relief was measured using the double stopwatch method. For each randomized subject, two stopwatches were started immediately after administration of the first study dose (Hour 0). The subject was to stop the first watch when they first perceived pain relief to occur (time to perceptible relief). Once the first watch was stopped, the second stopwatch was given to the subject with the instructions to stop the watch when they first experienced meaningful pain relief (time to meaningful relief).|12 Hours|ITT Population||hours||95% Confidence Interval|Median
634999|NCT02675907|Secondary|Time to Perceptible Pain Relief (TTPPR)|Time to perceptible and meaningful pain relief was measured using the double stopwatch method. For each randomized subject, two stopwatches were started immediately after administration of the first study dose (Hour 0). The subject was to stop the first watch when they first perceived pain relief to occur (time to perceptible relief). Once the first watch was stopped, the second stopwatch was given to the subject with the instructions to stop the watch when they first experienced meaningful pain relief (time to meaningful relief).|12 Hours|ITT Population||hours||95% Confidence Interval|Median
635000|NCT02675907|Secondary|Number of Doses of Rescue Analgesia Utilized Per Subject|Rescue analgesia (oral oxycodone 5 mg) was available to subjects with inadequately controlled pain upon request.|48 Hours|ITT Population||doses of rescue analgesia||Standard Error|Least Squares Mean
635001|NCT02675907|Secondary|Number of Subjects Utilizing Rescue Analgesia|Rescue analgesia (oral oxycodone 5 mg) was available to subjects with inadequately controlled pain upon request.|48 Hours|ITT Population||Participants|||Count of Participants
635002|NCT02675907|Secondary|Time to First Dose of Rescue Analgesia|Rescue analgesia (oral oxycodone 5 mg) was available to subjects with inadequately controlled pain upon request. Time to first rescue was calculated as the elapsed time from administration of Dose 1 to the administration of the first dose of rescue analgesia.|48 Hours|ITT Population||hours||95% Confidence Interval|Median
635003|NCT02675907|Secondary|Summed Pain Intensity Difference (SPID) at Other Intervals|Pain intensity was recorded using a Numeric Pain Rating Scale (Range 0-10) where 0 equates to no pain (better), and 10 equates to the worst pain imaginable (worse). Pain intensity scores were to be recorded at the following time points: 0.25, 0.5, 0.75, 1, and 2 hours post Dose 1. Thereafter pain assessments were to be recorded every 2 hours until 48 hours post Dose 1. Pain intensity differences from baseline at each time point were calculated and a time weighted summed pain intensity difference (SPID) was then calculated. Time weighted SPID calculations were computed by multiplying a weight factor to each score prior to summation. The weight factor at each time point was the time elapsed since the previous observation. A smaller SPID value (i.e. more negative) was better.|48 Hours|ITT Population||units on a scale||Standard Error|Least Squares Mean
635027|NCT02670473|Primary|Lens Tightness on Push-up|Lens fit evaluation of tightness on push-up test for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale: 0%-100%, 0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement.|Baseline, 1 week, 2 weeks, and 4 weeks|||mean of lens tightness||Standard Deviation|Mean
639810|NCT02371759|Primary|Heart Rate at 10 Minutes|Heart rate 5 minutes after local anesthesia injection, 10 minutes after baseline measurement|10th minute|||beats per minute||Standard Deviation|Mean
635004|NCT02675907|Primary|Summed Pain Intensity Difference Over the First 48 Hours (SPID48)|Pain intensity was recorded using a Numeric Pain Rating Scale (Range 0-10) where 0 equates to no pain (better), and 10 equates to the worst pain imaginable (worse). Pain intensity scores were to be recorded at the following time points: 0.25, 0.5, 0.75, 1, and 2 hours post Dose 1. Thereafter pain assessments were to be recorded every 2 hours until 48 hours post Dose 1. Pain intensity differences from baseline at each time point were calculated and a time weighted summed pain intensity difference (SPID) was then calculated. Time weighted SPID calculations were computed by multiplying a weight factor to each score prior to summation. The weight factor at each time point was the time elapsed since the previous observation. A smaller SPID value (i.e. more negative) was better.|48 Hours|Intent-to-Treat (ITT) population||units on a scale||Standard Error|Least Squares Mean
635006|NCT02675543|Primary|Vitreous Prostaglandin E2 Levels||intraoperarive|||pg/mL||Standard Deviation|Mean
635007|NCT02674334|Secondary|Change in Mini Mental State Exam (MMSE) > 2 or a Score of 23 up to Two Weeks After Surgery Minus Baseline Value|Change in total score of the MMSE measurement taken at baseline before surgery compared to the follow up measurement taken up to two weeks after surgery. Total range is zero to 30 with higher values indicating a better outcome. Indicator of cognitive decline measured by a change in Mini Mental State Exam (MMSE) > 2 or a score of 23 for two time points; up to two weeks after surgery minus the baseline value.|baseline and up to two weeks|Participants who underwent elective shoulder surgery in the beach chair position at West Virginia University Medicine Hospital.||scores on a scale|participants|Standard Error|Mean
635008|NCT02674334|Primary|Percentage of Participants With 20+% Cerebral Desaturation Events|Cerebral desaturation event defined as a 20% or greater decrease from baseline Mean Arterial Pressure, while undergoing elective ambulatory surgery in the beach chair position|one day|Participants undergoing elective shoulder surgery in the beach chair position at West Virginia University Medicine Hospital.||Participants|||Count of Participants
635009|NCT02673944|Primary|Accurate Vesical PRessure|To validate that the Peritron+ digital readings are identical to the urodynamic readings (+/- 3 cm H2O) in the sitting position.|During a routine urodynamic study (1 hr approx)|||cm H2O||Standard Deviation|Mean
635010|NCT02672514|Primary|Acute Kidney Injury||within the first 30 days (plus or minus 3 days) after surgery|||participants|||Number
635011|NCT02670811|Secondary|Triglycerides Measurements|Triglycerides measurements in baseline and after 8 weeks of treatment (intake period).|Baseline and 8th week|||mg/dL||Standard Deviation|Mean
635012|NCT02670811|Secondary|High Density Lipoproteins|High density lipoproteins measurements in baseline and after 8 weeks of treatment (intake period).|Baseline and 8th week|||mg/dL||Standard Deviation|Mean
635013|NCT02670811|Secondary|Low Density Lipoproteins Measurements|Low density lipoproteins measurements in baseline and after 8 weeks of treatment (intake period).|Baseline and 8th week|||mg/dL||Standard Deviation|Mean
635014|NCT02670811|Secondary|Total Cholesterol Measurements|Total cholesterol in baseline and after 8 weeks of treatment (Intake period).|Baseline and 8th week|||mg/dL||Standard Deviation|Mean
635015|NCT02670811|Secondary|Diastolic Blood Pressure Measurements|From randomization (baseline), eight weeks of intervention and two weeks post-treatment.|Baseline to 10 weeks|||mmHg||Standard Deviation|Mean
635016|NCT02670811|Primary|Systolic Blood Pressure Measurements|From randomization (baseline), eight weeks of intervention and two weeks after intervention was over.|Baseline to 10 weeks|||mmHg||Standard Deviation|Mean
635017|NCT02670473|Secondary|Corneal Staining|Corneal staining for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-4, 0.5 steps 0=normal, 4=severe.|Baseline, 1 week, 2 weeks, and 4 weeks|||percentage of eyes|||Number
635018|NCT02670473|Secondary|Conjunctival Staining|Conjunctival staining for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. (Scale 0-4, 0.5 steps 0=normal, 4=severe).|Baseline, 1 week, 2 weeks, and 4 weeks|||percentage of eyes|||Number
635019|NCT02670473|Secondary|Wearing Times|Average wearing time and comfortable wearing times for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks measured by hours.|Baseline, 1 week, 2 weeks, and 4 weeks|||hours||Standard Deviation|Mean
635020|NCT02670473|Secondary|Lens Preference Overall|Subject's overall preference for one of two contact lenses. Forced choice: enfilcon A habitual lens (control) or fanfilcon A lens (test).|1 week, 2 weeks, and 4 weeks|One participant withdrew from the study after week 1.||percentage of subjects|||Number
635021|NCT02670473|Secondary|Overall Satisfaction|Subjective rating of overall satisfaction for enfilcon A habitual lens (control) at baseline and fanfilcon A lens (test) at 1 week, 2 weeks, and 4 weeks. Scale 1-4, 1=completely satisfied, 2=somewhat satisfied, 3=somewhat dissatisfied, 4=completely dissatisfied.|Baseline, 1 week, 2 weeks, and 4 weeks|One participant withdrew from the study after week 1.||percentage of subjects|||Number
635022|NCT02670473|Secondary|Overall Vision Satisfaction|Subjective rating of overall vision satisfaction for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-10, 0=very dissatisfied, 10=very satisfied.|Baseline, 1 week, 2 weeks, and 4 weeks|||units on a scale||Standard Deviation|Mean
635023|NCT02670473|Secondary|Handling|Subjective rating of handling for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-10, 0=very difficult to handle, 10=very easy to handle.|Baseline, 1 week, 2 weeks, and 4 weeks|||units on a scale||Standard Deviation|Mean
635024|NCT02670473|Secondary|Dryness Overall|Subjective rating of overall dryness for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-10, 0=very dry, 10=no dryness.|Baseline, 1 week, 2 weeks, and 4 weeks|||units on a scale||Standard Deviation|Mean
635053|NCT02664987|Secondary|Sleep Disturbance Within Last 7 Days Assessed Using Questionnaire Answered by Patient|"Patients answered yes or no to the following question:
Have you had trouble sleeping due to your cancer pain within the last 7 days?"|Past 7 days up to Day 1|||percentage of patients|||Number
635028|NCT02670473|Primary|Lens Fit - Post-blink Movement|Lens fit evaluation of post-blink movement for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-5 Likert scale, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement.|Baseline, 1 week, 2 weeks, and 4 weeks|||percentage of eyes|||Number
635029|NCT02670473|Primary|Lens Fit - Centration|Lens fit evaluation of centration for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale: optimum, decentration acceptable, decentration unacceptable.|Baseline, 1 week, 2 weeks, and 4 weeks|||percentage of eyes|||Number
635030|NCT02669095|Primary|Overall Comfort|Clue comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. CLUE Comfort was assessed at 1-, 2-, 3 and 4- week Follow-up evaluations. The average CLUE comfort score for each lens was reported for each visit.|Up to 4 Week Follow-up|Subjects that completed all study visits without a major protocol deviation.||Units on a scale||Standard Deviation|Mean
635031|NCT02669095|Primary|Acceptable Lens Fitting|Lens fit was assessed and recorded for each subject and eye at post lens fitting, 1-, 2-, 3- and 4- week follow-up evaluations. Lens fit was a binary response acceptable and unacceptable lens fit. The proportion of eyes with acceptable lens fitting at post lens fit and across all four follow-ups was combined and reported.|Up to 4 Week Follow-up|Subjects that completed all study visits without a major protocol deviation.||Proportion of eyes|Subject Eyes||Number
635032|NCT02669043|Primary|Hamilton Depression Rating Scale (HDRS, HAM-D)|Continuous score of depression symptoms. The higher the score, the more severe the depression. HAMD scores range from 0 to 81.|48 hours|Patients who completed the study. Outcome measure was at 48 hours.||units on a scale||Full Range|Mean
635036|NCT02667704|Secondary|Area Under the Concentration-time Curve of Nintedanib in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity)|Area under the concentration-time curve of Nintedanib in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity). PK plasma samples were taken at: 1 hour (h) before drug administration and 30 minutes, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h, 144h, 144.5h, 145h, 145.5h, 146h, 146.5h, 147h, 148h, 149h, 150h, 152h, 154h, 156h, 168h, 180h, 192h, 216h after drug administration. Two different visits; Visit 2 (R): -1 to 72 h, Visit 3 (T) 144 to 216 h. AUC0-infinity was calculated for each visit separately.|Up to 216 hours. The details are mentioned in description.|Pharmacokinetic parameter analysis set (PKS): all subjects in the treated set who provided at least one primary or secondary pharmacokinetic (PK) parameter not flagged for exclusion due to a protocol violation relevant to the evaluation of PK or due to PK non-evaluability.||ng*h / mL||Geometric Coefficient of Variation|Geometric Mean
635037|NCT02667704|Primary|Maximum Measured Concentration of Nintedanib in Plasma (Cmax)|Maximum measured concentration of Nintedanib in plasma (Cmax). PK plasma samples were taken at: 1 hour (h) before drug administration and 30 minutes, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h, 144h, 144.5h, 145h, 145.5h, 146h, 146.5h, 147h, 148h, 149h, 150h, 152h, 154h, 156h, 168h, 180h, 192h, 216h after drug administration. Two different visits; Visit 2 (R): -1 to 72 h, Visit 3 (T) 144 to 216 h. Cmax was determined for each visit separately.|Up to 216 hours. The details are mentioned in description.|Pharmacokinetic parameter analysis set (PKS): all subjects in the treated set who provided at least one primary or secondary pharmacokinetic (PK) parameter not flagged for exclusion due to a protocol violation relevant to the evaluation of PK or due to PK non-evaluability.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
635054|NCT02664987|Primary|Intensity of Pain Currently and Over Past 24 Hours as Measured by NRS Scores Indicated by Patient|"Patients indicated their pain intensity using a numerical rating scale (NRS) ranging from 0 (no pain) to 10 (worst possible pain).
Their current pain intensity and pain in the last 24 hours were indicated on separate scales. A higher score indicates higher pain intensity."|Past 1 day up to Day 1|||units on a scale||Standard Deviation|Mean
682909|NCT01536067|Secondary|Frequency of Complete Remission (CR)||Every 28 days||||||
635038|NCT02667704|Primary|Area Under the Concentration-time Curve of Nintedanib in Plasma Over the Time Interval From 0 to the Last Quantifiable Concentration (AUC0-tz)|Area under the concentration-time curve of Nintedanib in plasma over the time interval from 0 to the last quantifiable concentration (AUC0-tz). PK plasma samples were taken at: 1 hour (h) before drug administration (approximate time for predose sample) and 30 minutes, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h, 144h, 144.5h, 145h, 145.5h, 146h, 146.5h, 147h, 148h, 149h, 150h, 152h, 154h, 156h, 168h, 180h, 192h, 216h after drug administration. Two different visits; Visit 2 (R): -1 to 72 h, Visit 3 (T) 144 to 216 h. AUC0-tz was calculated for each visit separately.|Up to 216 hours. The details are mentioned in description.|Pharmacokinetic parameter analysis set (PKS): all subjects in the treated set who provided at least one primary or secondary pharmacokinetic (PK) parameter not flagged for exclusion due to a protocol violation relevant to the evaluation of PK or due to PK non-evaluability.||nanogram (ng)*hour (h) /millilitre (mL)||Geometric Coefficient of Variation|Geometric Mean
635039|NCT02666560|Secondary|Time Spent in Single Support as Measured by the Gaitrite Walk-way System.|The Gaitrite is a portable gait analysis walk-way system that enables the temprospatial measures of gait to be recorded. This was record in percentage of time spent in double support (%).|Data was collected at a single time point for each condition. Conditions occurred within a two week time period.|||percentage of time||Standard Deviation|Mean
635040|NCT02666560|Secondary|Time Spent in Double Support as Measured by the Gaitrite Walk-way System.|The Gaitrite is a portable gait analysis walk-way system that enables the temprospatial measures of gait to be recorded. This was record in percentage of time spent in double support (%).|Data was collected at a single time point for each condition. Conditions occurred within a two week time period.|||percentage of time||Standard Deviation|Mean
635041|NCT02666560|Secondary|Cadence as Measured by the Gaitrite Walk-way System.|The Gaitrite is a portable gait analysis walk-way system that enables the temprospatial measures of gait to be recorded. The temprospatial measure of cadence was recorded in steps per minute.|Data was collected at a single time point for each condition. Conditions occurred within a two week time period.|||steps per minute||Standard Deviation|Mean
635042|NCT02666560|Secondary|Step Time as Measured by the Gaitrite Walk-way System.|The Gaitrite is a portable gait analysis walk-way system that enables the temprospatial measures of gait to be recorded. The temprospatial measure of step time was recorded in seconds.|Data was collected at a single time point for each condition. Conditions occurred within a two week time period.|||seconds||Standard Deviation|Mean
635043|NCT02666560|Secondary|Velocity as Measured by the Gaitrite Walk-way System.|The Gaitrite is a portable gait analysis walk-way system that enables the temprospatial measures of gait to be recorded. The temprospatial measure of velocity was recorded in cm's per second.|Data was collected at a single time point for each condition. Conditions occurred within a two week time period.|||cm/s||Standard Deviation|Mean
635044|NCT02666560|Primary|Step Length as Measured by the Gaitrite Walk-way System.|The Gaitrite is a portable gait analysis walk-way system that enables the temprospatial measures of gait to be recorded. The temprospatial measure of length was recorded in centimetres.|Data was collected at a single time point for each condition. Conditions occurred within a two week time period.|||cm||Standard Deviation|Mean
635045|NCT02666222|Secondary|Improvement in Quality of Life as Reflected by Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire|"APHAB results were obtained from baseline aided condition through Year 5 of follow up. The APHAB responses are in terms of percent of time an individual experiences problems, on a scale of 0-100%; lower scores indicate fewer problems.Compared scores with Esteem to scores in baseline aided condition, calculated as APHAB Global score at baseline minus APHAB Global score at Year 5, giving a difference in benefit score. The Global Score is the mean of the scores (% of problems) for Ease of Communication (EC), Reverberation (RV), and Background Noise (BN) subscales of the APHAB. A positive difference in benefit score indicates more benefit with Esteem."|Baseline through Year 5 of Follow Up|5 Year Follow-up||difference score in units on a scale||Full Range|Mean
635046|NCT02666222|Primary|Bone Conduction Stability|ENDPOINT #5: Difference between Baseline and 5 Year Pure-Tone Average (PTA; average of 500, 1000, 2000 Hz thresholds); calculated as PTA at Year 5 minus PTA at baseline. Smaller magnitude dB difference indicates better outcome.|Baseline through 5 Year Follow-Up|Difference between Baseline and 5 Year PTA (average of 500, 1000, 2000 Hz thresholds)||dB||Standard Error|Mean
635047|NCT02666222|Primary|Incidence of Serious Adverse Device Events (SADEs) and Device Failures and Replacements at Each Follow-up.|ENDPOINT #3: The analysis of the incidence of SADEs and device failures and replacements at each follow-up.|SADEs, PAS phase through Year 5 of Follow Up|Cumulative through 5-Year Follow-up||participants|||Number
635048|NCT02666222|Primary|Change From Baseline (Pre-implant Aided Condition) at Year 5 in Word Recognition Score (WRS) at 50 dB HL|ENDPOINT #2: WRS at Year 5 minus WRS at baseline. Positive difference (in % correct) indicates better outcome.|Baseline through Year 5 of Follow Up|5 Year Follow-up Visit||percentage of correct responses||Standard Error|Mean
635049|NCT02666222|Primary|Change From Baseline (Pre-implant Aided Condition) at Year 5 in Speech Reception Threshold (SRT)|ENDPOINT #1: SRT at baseline minus SRT at Year 5. Positive difference (i.e. lower value of SRT with the Esteem) indicates better outcome.|Baseline through Year 5 of Follow Up|5 Year Follow-up||dB||Standard Error|Mean
635050|NCT02665260|Secondary|Number of Subjects Who Experienced an Adverse Event|Number of subjects who experienced an adverse event as assessed by patient-reported outcomes questionnaire at each visit|33 weeks|||Participants|||Count of Participants
635051|NCT02665260|Primary|Number of Subjects Who Achieve Complete Clearance at 6 Weeks|Assess number of subjects who achieve a lesion count of zero at 6 weeks (end of open-label phase)|6 weeks|||Participants|||Count of Participants
635052|NCT02664987|Secondary|Patient's Performance Status as Measured by Investigator's Rating on ECOG PS Scale|"The Eastern Cooperative Oncology Group Performance Status (ECOG PS) scale ranges from 0 to 4:
0- Fully active, able to carry on all pre-disease performance without restriction
Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work
Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours
Capable of only limited self-care, confined to bed or chair more than 50% of waking hours
Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair
A higher score indicates greater functional impairment."|Day 1|||percentage of patients|||Number
639811|NCT02371759|Primary|Baseline Values of Heart Rate||baseline, 0 minutes|||beats per minute||Standard Deviation|Mean
635055|NCT02664987|Primary|Quality of Life as Measured Using EQ-5D-3L Questionnaire Answered by Patient|EQ-5D-3L summary indices were calculated using the algorithm developed based on the valuation of EQ-5D-3L health states from an adult Thai population (Tongsiri & Cairns, 2011). Applying the Thai algorithm, EQ-5D-3L summary indices range from -0.45 to 0.80, with an EQ-5D-3L summary index of 0.80 indicating the best overall health-related quality of life.|Day 1|||units on a scale||Standard Deviation|Mean
635056|NCT02664987|Primary|Satisfaction With Patient's Pain Control as Measured by 5-point Scale Answered by Patients and Investigators|"The scale used to measure a patient's satisfaction with pain control ranges from 1 to 5:
Very satisfied
Satisfied
Acceptable
Dissatisfied
Very dissatisfied
Patients and Investigators will each indicate their opinion on separate scales."|Day 1|||percentage of patients|||Number
635057|NCT02664987|Primary|Prescription Pattern of Analgesics (Opioid or Non-opioid)|At Visit 1 (Day 1) which was the only visit in the study, data was collected on whether each patient was receiving only opioid, only non-opioid or both opioid and non-opioid analgesic treatments for pain control.|Day 1|||percentage of patients||95% Confidence Interval|Number
635058|NCT02664610|Secondary|Mean Change in Diastolic Blood Pressure||Baseline to 6 months|||mmHg||Standard Deviation|Mean
635059|NCT02664610|Primary|Mean Change in Systolic Blood Pressure||Baseline to 6 months|||mmHg||Standard Deviation|Mean
635060|NCT02664532|Secondary|Total Laryngoscopy Duration in Seconds|The duration of intubation was defined as the time taken from placement of the laryngoscope in the mouth to the time taken to remove the laryngoscope from the mouth following intubation.|180 seconds|||Seconds||Standard Deviation|Mean
635061|NCT02664532|Secondary|Number of Intubation Attempts|An intubation attempt is defined as “intubation activities occurring during a single continuous laryngoscopy maneuver”. Thus, even if several attempts were made to place an endotracheal tube during the course of a single laryngoscopy, this would be counted as a single intubation attempt.|180 seconds|||participants|||Number
635062|NCT02664532|Secondary|Cormack Lehane Grading|Grade 1 Full view of glottis Grade 2 Only posterior commissure visible Grade 3 Only epiglottis visible Grade 4 No glottis structure visible|60 seconds|||participants|||Number
635063|NCT02664532|Primary|Ease of Intubation or Degree of Difficulty With Intubation|Degree of difficulty with intubation Grade 1 Intubation easy Grade 2 Intubation requiring an increased anterior lifting force/optimal external laryngeal manipulation (OELM)/assistance to pull the right corner of the mouth upwards to augment space Grade 3 Intubation requiring more than one attempt or bougie guided intubation Grade 4 failure to intubate with the assigned laryngoscope|60 seconds|||participants|||Number
635064|NCT02664311|Secondary|Fluoroscopy Time|Fluoro time as recorded by RNs from Xray machine|Immediate post-procedure|||minutes||Standard Deviation|Mean
635065|NCT02664311|Secondary|Freedom From AF||1 year|||Participants|||Count of Participants
635066|NCT02664311|Primary|Isolation Time|Comparison of Time (in Minutes) From Obtaining Access to Left Atrium Via Transseptal Catheterization to Demonstrated Isolation of All Pulmonary Veins - hypothesis is that with Jet ventilation there will be a shorter time to pulmonary vein isolation in comparison to conventional ventilation|Immediate post procedure|||minutes||Standard Deviation|Mean
635067|NCT02663453|Secondary|Assessment of Aspartate Aminotransferase (AST)|blood samples were obtained before enrollment, week 1, 2 and 3 (U/L) after parenteral nutrition administration|3 month|||U/L||Standard Deviation|Mean
635068|NCT02663453|Secondary|Assessment of Alanine Aminotransferase (ALT)|blood samples were obtained before enrollment, week 1, 2 and 3 (U/L) after parenteral nutrition administration|3 month|||U/L||Standard Deviation|Mean
635069|NCT02663453|Secondary|Assessment of Gamma Glutamyltranspeptidase (GGT)|blood samples were obtained before enrollment, week 1, 2 and 3 (U/L) after parenteral nutrition administration|3 month|||U/L||Standard Deviation|Mean
635070|NCT02663453|Secondary|Head Circumference Gain|in-hospital head circumference gain at birth until discharge (cm/week)|up to 24 weeks|||cm/week||Standard Deviation|Mean
635071|NCT02663453|Secondary|Height Gain|in-hospital height gain at birth until discharge (cm/week)|up to 24 weeks|||cm/week||Standard Deviation|Mean
635072|NCT02663453|Secondary|Weight Gain|in-hospital weight gain at birth until discharge (gram/day)|up to 24 weeks|||gram/day||Standard Deviation|Mean
635073|NCT02663453|Secondary|Incidence of Extrauterine Growth Restriction (EUGR)|weight that is less than the tenth percentile for corrected gestational age by the time of discharge|up to 24 weeks|||Participants|||Count of Participants
635074|NCT02663453|Secondary|Neonatal Morbidities|retinopathy of prematurity, bronchopulmonary dysplasia|4 months|||Participants|||Count of Participants
635075|NCT02663453|Primary|Incidence of Neonatal Cholestasis|direct bilirubin level of more than 2 mg/dL|3 months|||Participants|||Count of Participants
635076|NCT02663232|Secondary|Percentage of Participants With Adequate Quality/Quantity of Tumor Sample||Day 1|All participants enrolled in the study were included in the analysis.||percentage of participants|||Number
635077|NCT02663232|Secondary|Percentage Participants Categorized by the Percentage of Tumor Cells Referred to the Technique|The samples were classified based on the percentage of tumor cells referred to the technique as follows: <60 percent (%), 60-80%, >80% and Unknown.|Day 1|All participants enrolled in the study were included in the analysis.||percentage of participants|||Number
635078|NCT02663232|Secondary|Percentage of Participants Categorized by Method of BRAF Mutation Testing (Cobas® 4800 BRAF V600 Mutation Test or Others)||Day 1|All participants enrolled in the study were included in the analysis.||percentage of participants|||Number
635079|NCT02663232|Secondary|Percentage of Participants Categorized by Method of DNA Extraction (Cobas® BRAF V600 Mutation Test or Others)||Day 1|All participants enrolled in the study were included in the analysis.||percentage of participants|||Number
635080|NCT02663232|Secondary|Percentage of Participants With Vascular Invasion|Vascular invasion is defined as the appearance of cancer cells in the lymphatic and blood streams.|Day 1|All participants enrolled in the study were included in the analysis.||percentage of participants|||Number
635081|NCT02663232|Secondary|Percentage of Participants With Regression|Regression in melanoma is the replacement of tumor tissue with fibrosis, degenerated melanoma cells, lymphocytic proliferation, and telangiectasia formation.|Day 1|All participants enrolled in the study were included in the analysis.||percentage of participants|||Number
635082|NCT02663232|Secondary|Percentage of Participants With Ulceration||Day 1|All participants enrolled in the study were included in the analysis||percentage of participants|||Number
635083|NCT02663232|Secondary|Percentage of Participants Categorized by Breslow Thickness|Breslow thickness is defined as the total vertical height of the melanoma, from the very top (called the granular layer) to the area of deepest penetration in the skin. An instrument called an ocular micrometer is used to measure the thickness of the excised (removed) tumor. In general, the higher the Breslow thickness, the worse the prognosis. The classifications were lesser than or equal to (≤) 1.0 millimeters (mm), 1.01 - 2.0 mm, 2.01 - 4.0 mm, greater than (>) 4.0 mm and Unknown.|Day 1|All participants enrolled in the study were included in the analysis.||percentage of participants|||Number
635084|NCT02663232|Secondary|Percentage of Participants Categorized by Method of Fixation (Buffered Formalin or Others)||Day 1|All participants enrolled in the study were included in the analysis.||percentage of participants|||Number
635085|NCT02663232|Secondary|Percentage of Participants Categorized by Tumor Sample Type (Paraffin-embedded Tissue Blocks, Paraffin Block Slides, Cytology Slides, or Other)||Day 1|All participants enrolled in the study were included in the analysis.||percentage of participants|||Number
635086|NCT02663232|Secondary|Percentage of Participants Categorized by Tumor Sample Source (Primary Tumor or Metastatic Sites)||Day 1|All participants enrolled in the study were included in the analysis.||percentage of participants|||Number
635087|NCT02663232|Secondary|Median Time Since Diagnosis of Melanoma|Median time from the diagnosis of primary melanoma to advanced disease was determined in years.|Day 1|All participants enrolled in the study were included in the analysis except for one participant with missing data.||years||Full Range|Median
635088|NCT02663232|Secondary|Percentage of Participants Categorized By LDH Level|Normal LDH levels range from 140 units per liter (U/L) to 280 U/L.|Day 1|All participants enrolled in the study were included in the analysis.||percentage of participants|||Number
635089|NCT02663232|Secondary|Percentage of Participants Categorized by Primary Tumor Location|Primary tumor location included limbs (upper and lower extremities), trunk, head/neck, mucosa, uveal, acral, other (other than these specified locations), unknown (exact location unknown), and not available.|Day 1|All participants enrolled in the study were included in the analysis.||percentage of participants|||Number
635090|NCT02663232|Secondary|Percentage of Participants With Sun Exposure|Data were obtained to classify the population with sun exposure as those with low, intermittent or chronic exposure. For the sub-analysis of low, intermittent and chronic exposure, percentages were calculated based on the population with any sun exposure.|Day 1|All participants enrolled in the study were included in the analysis.||percentage of participants|||Number
635091|NCT02663232|Secondary|Percentage of Participants With Family History of Melanoma||Day 1|All participants enrolled in the study were included in the analysis.||percentage of participants|||Number
635092|NCT02663232|Secondary|Percentage of Participants Categorized by Melanoma Stage|Melanoma stages were categorized (according to American Joint Committee on Cancer [AJCC]) as IIIc (advanced stage of melanoma), M1a (metastases to skin, subcutaneous, or distant lymph nodes, normal lactate dehydrogenase (LDH) level, M1b (lung metastases, normal LDH) and M1c (metastases to all other visceral sites and normal LDH or distant metastases to any site combined with an elevated serum LDH level). Of these Stage IIIc was used as the referral category for comparisons.|Day 1|All participants enrolled in the study were included in the analysis.||percentage of participants|||Number
635093|NCT02663232|Primary|Percentage of Participants With V600 BRAF Mutation Status|Presence or absence of mutations in the V600 BRAF oncogene was determined in all eligible participants. Data collection and management of BRAF mutation testing was carried out using the Biomarker point® online platform. The platform was used as an electronic case report form (e-CRF) for collecting information in electronic format via a website. Percentage of participants with BRAF mutation status (mutated BRAF, wild type, not available) were reported.|Day 1|All enrolled participants were included in the analysis.||percentage of participants||95% Confidence Interval|Number
635094|NCT02662608|Primary|Number of Participants With Disease Progression|Tumor response for measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) to establish disease progression. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|6 weeks|||Participants|||Count of Participants
635095|NCT02662556|Secondary|Percentage of Healthcare Professionals Who Responded to the Global Assessments as “Excellent” or “Good”|"Healthcare professionals were asked “Overall, how would you rate the method of pain control? Poor (1) Fair (2) Good (3) Excellent (4)"|12 hours or until patients' termination from study|||percentage of healthcare professionals||95% Confidence Interval|Number
635096|NCT02662556|Secondary|Percentage of Patients Who Responded to the Global Assessments as “Excellent” or “Good”|"Patients were asked “Overall, how would you rate the method of pain control? Poor (1), Fair (2), Good (3), or Excellent (4)"|12 hours or at patients' termination from study|135 patients completed the scale||percentage of subjects||95% Confidence Interval|Number
635097|NCT02662556|Secondary|Time-weighted Summed Pain Intensity Difference (SPID) Over the First Hour (SPID1).|The pain intensity difference (PID) at each evaluation time point after the dose of study drug is the difference in pain intensity at the specific evaluation time point and baseline pain intensity [PID(evaluation time after the first dose) = PI(baseline) – PI(evaluation time after the first dose)]. A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and throughout the 1 hour period. The time-weighted SPID1 is the time-weighted summed PID over the 1-hour study period. The scores ranged from -6.67 to 6.77. A negative score indicates an increase in pain intensity and a higher score indicates a greater decrease in pain intensity.|1 hours|||units on a scale||Standard Error|Mean
635098|NCT02662556|Primary|Time-weighted Summed Pain Intensity Difference (SPID) Over the 12-hour Study Period (SPID12).|The pain intensity difference (PID) at each evaluation time point after the dose of study drug is the difference in pain intensity at the specific evaluation time point and baseline pain intensity [PID(evaluation time after the first dose) = PI(baseline) – PI(evaluation time after the first dose)]. A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and throughout the 12 hour period. The time-weighted SPID12 is the time-weighted summed PID over the 12-hour study period. The scores ranged from -13.75 to 100.5. A negative score indicates an increase in pain intensity and a higher score indicates a greater decrease in pain intensity.|12-hours|||units on a scale||Standard Error|Mean
639812|NCT02371759|Primary|Diastolic Blood Pressure at 35 Minutes|Diastolic blood pressure values 30 minutes after local anesthesia injection|35th minute|||milimeters of Hg||Standard Deviation|Mean
635100|NCT02662387|Primary|Change of Respiratory Status Using the Modified Bronchiolitis Severity Score, in Children Using External Nasal Dilators as an Adjuvant to High Flow Nasal Cannula Oxygen Therapy Compared to Those Receiving High Flow Nasal Cannula Therapy Alone|Change of respiratory status using the Modified Bronchiolitis Severity Score in children using External Nasal Dilators as an adjuvant to High Flow Nasal Cannula oxygen therapy compared to those receiving High Flow Nasal Cannula therapy alone - shows that there is change in respiratory parameters, with positive number reflecting increases, and negative numbers reflecting decreases in number Modified Bronchiolitis Severity Score is measured by combining the individual score for five respiratory parameters (respiratory rate, breath sounds, work of breathing, oxygen saturation, mental status); score for each parameter ranges from 0-3; final score of each parameter is measured by adding them up; and so MBSS score ranges from 0-15; higher the score, worse the clinical status)|Change from baseline to time of hospital discharge, no greater than 1 month|||number/score||Full Range|Mean
635101|NCT02658461|Secondary|Total Participant Time Per Episode of Care Spent in the Chair for Administration of Trastuzumab|The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. Start and stop 'chair' times were recorded to determine the total time spent in the treatment chair during a single episode of care. The average time spent in the chair per episode was calculated and expressed in minutes.|Data collection up to 1 year|Total Sample||minutes|Participants|Standard Deviation|Mean
635102|NCT02658461|Secondary|Total Participant Time Per Episode of Care Spent in the Care Unit for Administration of Trastuzumab|The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. Arrival and discharge times were recorded to determine the total time spent in the care unit during a single episode of care. The average time spent in the care unit per episode was calculated and expressed in minutes.|Data collection up to 1 year|Total Sample||minutes|Participants|Standard Deviation|Mean
635103|NCT02658461|Secondary|Number of Consumable Medical Supplies Used Per Episode of Care in the Preparation of Trastuzumab IV Infusion|The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. Consumable medical supplies used in the preparation of trastuzumab IV infusion were counted during a single episode of care. The average number of each type of consumable used per episode was calculated.|Data collection up to 1 year|Consumables Sample for Trastuzumab IV Infusion; number (n) of observations per item are shown.||consumables|Participants|Standard Deviation|Mean
635104|NCT02658461|Secondary|Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab IV Infusion|The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. Consumable medical supplies used in the administration of trastuzumab IV infusion were counted during a single episode of care. The average number of each type of consumable used per episode was calculated.|Data collection up to 1 year|Consumables Sample for Trastuzumab IV Infusion: All observations of an episode of care with trastuzumab IV infusion that utilized any of the recorded consumable supplies; number (n) of observations per item are shown.||consumables|Participants|Standard Deviation|Mean
635105|NCT02658461|Secondary|Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab SC Injection|The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. Consumable medical supplies used in the administration of trastuzumab SC injection were counted during a single episode of care. The average number of each type of consumable used per episode was calculated.|Data collection up to 1 year|Consumables Sample for Trastuzumab SC Injection: All observations of an episode of care with trastuzumab SC injection that utilized any of the recorded consumable supplies; number (n) of observations per item are shown.||consumables|Participants|Standard Deviation|Mean
635106|NCT02658461|Secondary|Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab Single-Use Injection Device|The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. Consumable medical supplies used in the administration of trastuzumab single-use injection device were counted during a single episode of care. The average number of each type of consumable used per episode was calculated.|Data collection up to 1 year|Consumables Sample for Trastuzumab Single-Use Injection Device: All observations of an episode of care with trastuzumab single-use injection device that utilized any of the recorded consumable supplies; number (n) of observations per item are shown.||consumables|Participants|Standard Deviation|Mean
635107|NCT02658461|Secondary|Total HCP Time Required Per Episode of Care in the Preparation of Trastuzumab IV Infusion|The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time spent on each pre-specified task in the preparation of trastuzumab IV infusion was recorded during each episode of care. Total HCP time was determined by adding together the time spent on all tasks. The average total HCP time per episode was calculated and expressed in minutes.|Data collection up to 1 year|Total Sample||minutes|Participants|Standard Deviation|Mean
635108|NCT02658461|Secondary|Total HCP Time Required Per Episode of Care in the Administration of Trastuzumab IV Infusion|The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time spent on each pre-specified task in the administration of trastuzumab IV infusion was recorded during each episode of care. Total HCP time was determined by adding together the time spent on all tasks. The average total HCP time per episode was calculated and expressed in minutes.|Data collection up to 1 year|Total Sample||minutes|Participants|Standard Deviation|Mean
635109|NCT02658461|Secondary|Total HCP Time Required Per Episode of Care in the Administration of Trastuzumab SC Injection|The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time spent on each pre-specified task in the administration of trastuzumab SC injection was recorded during each episode of care. Total HCP time was determined by adding together the time spent on all tasks. The average total HCP time per episode was calculated and expressed in minutes.|Data collection up to 1 year|Total Sample||minutes|Participants|Standard Deviation|Mean
635110|NCT02658461|Secondary|Total HCP Time Required Per Episode of Care in the Administration of Trastuzumab Single-Use Injection Device|The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time spent on each pre-specified task in the administration of trastuzumab single-use injection device was recorded during each episode of care. Total HCP time was determined by adding together the time spent on all tasks. The average total HCP time per episode was calculated and expressed in minutes.|Data collection up to 1 year|Total Sample||minutes|Participants|Standard Deviation|Mean
635111|NCT02658461|Secondary|Task-Specific HCP Time Required Per Episode of Care in the Preparation of Trastuzumab IV Infusion|The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time spent on each pre-specified task in the preparation of trastuzumab IV infusion was recorded during each episode of care. The average task-specific HCP time per episode was calculated and expressed in minutes.|Data collection up to 1 year|Total Sample; number (n) of observations per task are shown.||minutes|Participants|Standard Deviation|Mean
635112|NCT02658461|Secondary|Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab IV Infusion|The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time spent on each pre-specified task in the administration of trastuzumab IV infusion was recorded during each episode of care. The average task-specific HCP time per episode was calculated and expressed in minutes.|Data collection up to 1 year|Total Sample; number (n) of observations per task are shown.||minutes|Participants|Standard Deviation|Mean
635113|NCT02658461|Secondary|Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab SC Injection|The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time spent on each pre-specified task in the administration of trastuzumab SC injection was recorded during each episode of care. The average task-specific HCP time per episode was calculated and expressed in minutes.|Data collection up to 1 year|Total Sample; number (n) of observations per task are shown.||minutes|Participants|Standard Deviation|Mean
635114|NCT02658461|Secondary|Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab Single-Use Injection Device|The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time spent on each pre-specified task in the administration of trastuzumab single-use injection device was recorded during each episode of care. The average task-specific HCP time per episode was calculated and expressed in minutes.|Data collection up to 1 year|Total Sample; number (n) of observations per task are shown.||minutes|Participants|Standard Deviation|Mean
635115|NCT02658461|Secondary|Monetary Cost of Health Care Resources Used Per Episode of Care in Preparation and Administration of Trastuzumab IV Infusion|The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time was estimated using hourly salary data from NHS reference costs. Consumable supplies were costed using hospital pharmacy data and online sources. Analysis was limited to only those items with an individual cost of £0.05 or more. Monetary cost of health care resources was determined by adding the costs of consumable supplies and HCP time spent in the preparation and administration of trastuzumab IV infusion during a single episode of care. The average monetary cost per episode was calculated and expressed in pounds.|Data collection up to 1 year|Total Sample||pounds|Participants|Standard Deviation|Mean
635116|NCT02658461|Primary|Monetary Cost of Health Care Resources Used Per Episode of Care in Administration of Trastuzumab SC Injection|The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time was estimated using hourly salary data from NHS reference costs. Consumable supplies were costed using hospital pharmacy data and online sources. Analysis was limited to only those items with an individual cost of £0.05 or more. Monetary cost of health care resources was determined by adding the costs of consumable supplies and HCP time spent in the administration of trastuzumab SC injection during a single episode of care. The average monetary cost per episode was calculated and expressed in pounds.|Data collection up to 1 year|Total Sample||pounds|Participants|Standard Deviation|Mean
635117|NCT02658461|Primary|Monetary Cost of Health Care Resources Used Per Episode of Care in Administration of Trastuzumab Single-Use Injection Device|The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time was estimated using hourly salary data from National Health Service (NHS) reference costs. Consumable supplies were costed using hospital pharmacy data and online sources. Analysis was limited to only those items with an individual cost of £0.05 or more. Monetary cost of health care resources was determined by adding the costs of consumable supplies and HCP time spent in the administration of trastuzumab single-use injection device during a single episode of care. The average monetary cost per episode was calculated and expressed in pounds.|Data collection up to 1 year|Total Sample: All observations of an episode of care for the given treatment route.||pounds|Participants|Standard Deviation|Mean
635118|NCT02657629|Primary|Weight Gain in Grams Per Day||Daily until hospital discharge (up to maximum of 3 months of age)|||grams/day||Standard Deviation|Mean
635119|NCT02657538|Secondary|Lesion Activity|active lesions: 1; inactive lesions: 0|One year|The data were not collected and the Outcome will never be analyzed because of the study population. The participants are all low risk in the analysis of caries, with low amount of gingivitis and good oral hygiene what means that no progression/ change in caries activity will be detectable in any patient. So it doesn't make sense to analyze it.|||||
635120|NCT02657538|Primary|Caries Extension According to Diagnocam Codes 0-4 (Intra- and Interrater-Reliability, Sensitivity and Specificity)|"The geometrical shape of caries lesions is displayed with the near infrared transillumination method. These shapes are classified as: code 0: no lesion visible; code 1: first visible signs in enamel; code 2: established, clear visible signs in enamel; code 3: clear visible in enamel and punctual contact with dentine; code 4: clearly visible and broad contact with dentine
Intra- and Interrater-Reliability: Reliability indicates the overall consistency of a measurement. To have a high reliability means in this case, that the diagnostic-tool produces similar results under consistent conditions. The interrater-Reability assesses the degree of agreement between two different raters in their diagnostics on a specific test while the intrarater-Reliability assesses the degree of agreement of a single rater who did a diagnostic-test twice under the same testing conditions.
Sensitivity and Specificity: Statistics are not done yet but will be updated when we calculated them"|One year|||weighted Kappa|Participants|95% Confidence Interval|Mean
635121|NCT02656485|Secondary|Efficacy|Absolute Change from Baseline in Total Number of Lesions|Baseline and 4 weeks|All efficacy and safety data were analyzed using the ITT/Safety population.||Lesions||Standard Deviation|Mean
635122|NCT02656485|Primary|Safety (Number of Participants With Treatment Related Adverse Events)|Number of participants with treatment related adverse events as assessed by physical examination, vital signs, clinical laboratory values, local skin responses|4 weeks|The safety analysis set included all subjects in the ITT/Safety population.||Participants|||Count of Participants
639813|NCT02371759|Primary|Diastolic Blood Pressure at 20 Minutes|Diastolic blood pressure values 15 minutes after local anesthesia injection|20th minute|||milimeters of Hg||Standard Deviation|Mean
635123|NCT02656160|Secondary|Change in EMG GG for cmH2O Change in Epiglottic Pressure. (GG%Max/cmH2O)|Effect of dalfampridine on genioglossus muscle responsiveness to increased epiglottic pressure swings during sleep in healthy controls during NREM sleep. The variation of EMG GG is expressed here as % of maximal activation.|1 night|||%max/cmH2O||Inter-Quartile Range|Median
635124|NCT02656160|Primary|Genioglossus Activity During Sleep Expressed as %Wakefulness Value (Before Drug/Placebo Administration).|The EMG GG was quantified in arbitrary units derived from signal processing of the raw signal and as a percentage of wakefulness (%wake) for between-nights comparison of baseline sleep EMG GG activity. EMG GG analysis was performed on a breath-by-breath basis to identify a maximum value and a minimum value during inspiration and expiration, respectively (EMG GG peak and tonic). The difference between peak and tonic values was used to estimate respiratory related phasic activity. Wakefulness EMG GG values were obtained from a minimum of 10 epochs (30 s each) with the subject lying in the lateral position. Criteria for breath selection during wakefulness were (1) stable breathing (constant epiglottic pressure swings) and (2) absence of movement artifacts (i.e., swallowing, speech, yawns).|1 night|||percentage of wakefulness value||Inter-Quartile Range|Median
635125|NCT02653560|Primary|24-hour Average Systolic Blood Pressure|Systolic blood pressure was measured through an ambulatory blood pressure monitoring device worn by each participant for 24 hours after completing each treatment phase. This devise measures blood pressure intermittently throughout the day and night and provides the average of all readings.|4 weeks|||mmHg||Standard Deviation|Mean
635126|NCT02653495|Secondary|Antibody Response D90|Measured by hemagglutination inhibition assay|90 days after vaccination compare to day 28|Data were not collected.|||||
635127|NCT02653495|Secondary|Gene Expression Profiling D90|Analyze by RNA-seq|90 days post-vaccination compare to baseline (gene expression screening visit #1 and study visit #1 D0 of vaccination)|Data were not collected.|||||
635128|NCT02653495|Secondary|Gene Expression Profiling D28|Analyze by RNA-seq|28 days post-vaccination compare to baseline (gene expression screening visit #1 and study visit #1 D0 of vaccination)|Data were not collected.|||||
635129|NCT02653495|Secondary|Gene Expression Profiling D1|Analyze by RNA-seq|1 day post-vaccination compare to baseline (gene expression screening visit #1 and study visit #1 D0 of vaccination)|Data were not collected.|||||
635130|NCT02653495|Primary|Antibody Response D28|Measured by hemagglutination inhibition assay|28 days after vaccination compare to baseline (screening visit 1) pre-vaccination|Data were not collected|||||
635131|NCT02652221|Primary|Agreement in Measured Liver Stiffness Between ARFI and MRE|The investigators are seeking to define agreement between ARFI and MRE liver stiffness measurements obtained in the same patients on the same day to determine if the modalities can be used interchangeably for measurement of liver stiffness and prediction of significant liver fibrosis|Within 24 hours|||Correlation Coefficient (rho)|||Number
635132|NCT02652221|Primary|Agreement in Measured Liver Stiffness Between ARFI and MRE|The investigators are seeking to define agreement between ARFI and MRE liver stiffness measurements obtained in the same patients on the same day to determine if the modalities can be used interchangeably for measurement of liver stiffness and prediction of significant liver fibrosis|Within 24 hours|||kPa|||Number
635133|NCT02652208|Secondary|Satisfaction With the Intervention|"Number of respondents who rated the material as very good or excellent."|Within 1 week after reviewing the decision aid|All participants who completed and returned a survey within the 6 month study period.||Participants|||Count of Participants
635134|NCT02652208|Secondary|Treatment Leaning (Percentage of Patients Who Have a Clear Treatment Preference)|To determine the percentage of patients who have a clear treatment preference for their stable chest discomfort.|Within 1 week after reviewing the decision aid|Only participants who indicated they currently had symptoms were asked to complete the item||Participants|||Count of Participants
635135|NCT02652208|Primary|Total Knowledge Score|Six multiple choice knowledge items covered important facts patients should know about chest pain or discomfort and treatments. A total knowledge score (0-6) was created by summing the total number of correct responses. A missing knowledge response was marked as incorrect. Any survey with more than three missing knowledge responses did not get a total knowledge score. A higher score indicates higher knowledge on the topic. Both decision aids provided information for answering all knowledge items. Higher knowledge scores are better.|Within 1 week after reviewing the decision aid|All participants who completed and returned a survey within the 6 month study period.||knowledge score||Standard Deviation|Mean
635136|NCT02651922|Secondary|Tolerability Assess Using a 5 Point Scale|Assessment of tolerability using a 5 point scale (very good, good, satisfactory, bad, very bad)|Evaluation of Tolerability on visit 3 (appr. 12 weeks after baseline)|||participants|||Number
635137|NCT02651922|Secondary|Change of EQ-5D VAS Scores (Pre - Post)|VAS values (Quality of Life) range from 0 (very poor) to 100 (best possible state).|Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)|||participants|||Number
635138|NCT02651922|Secondary|Change in EQ-5D (Health Questionnaire) Scores (Pre - Post)|EQ-5D™ is a standardised instrument for use as a measure of health Outcome The EQ-5D assesses five aspects of QoL: mobility, self-care, usual activity, pain/discomfort and anxiety/depression. An EQ-5D profile score of 0 points represents the worst QoL (death), while 1 point stands for full health. Data analysis was performed according to the EuroQol manual. The EQ-VAS ranges from 0 (worst QoL) to 100 (best QoL).|Change from Baseline (before treatment) to last visit (end of observation- approx. 12 weeks after baseline)|||participants|||Number
635139|NCT02651922|Secondary|Change of RS-13 (Resilience Questionnaire) (Pre - Post)|RS-13 is a 13 items self Report questionnaire measure the resilience, which applies a reliance scale ranging from 13 (lowest stress resistance) to 91 (highest stress resistance).|Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)|||participants|||Number
635140|NCT02651922|Secondary|Change of BDEPQ (Benzodiazepine Dependence Questionnaire)|"The Benzodiazepine Dependence Questionnaire (BDEPQ) is a 30 item self report questionnaire designed to measure dependence on benzodiazepine tranquilisers, sedatives and hypnotics. Items cover all aspects of the dependence syndrome with the exception of withdrawal symptoms. Each item is rated on a four point likert scale referring to experiences in the last month.
BDEPQ score ranges from 0 (no dependence) to 85 (most severe dependence)."|Change from visit 2 (approx. 4 weeks after baseline) to last visit (end of observation- approx. 12 weeks after baseline)|"For patient with less than 75% items answered the BDEPQ-Score was not calculated.
For only 132 patients Score was calculated."||participants|||Number
635141|NCT02651922|Secondary|Change of Symptom Palpation (Pre - Post)|Symptom was assessed in a Likert scale ranging from 0 “no symptoms at all” to 10 “very severe symptoms”|Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)|"If a symptom was rated 0, it was considered nonexistent. For any other rating (1 to 10) the symptom was considered existent.
Only 130 patients showed this symptom."||participants|||Number
635142|NCT02651922|Secondary|Change of Symptom Trembling (Pre - Post)|Symptom was assessed in a Likert scale ranging from 0 “no symptoms at all” to 10 “very severe symptoms”|Change from Baseline (before treatment; week 0) to last visit (end of observation - approx. 12 weeks after baseline)|"If a symptom was rated 0, it was considered nonexistent. For any other rating (1 to 10) the symptom was considered existent.
Only 108 patients showed this symptom."||participants|||Number
635143|NCT02651922|Secondary|Change of Symptom Nausea (Pre - Post)|Symptom was assessed in a Likert scale ranging from 0 “no symptoms at all” to 10 “very severe symptoms”|Change from Baseline (before treatment; week 0) to last visit (end of observation-approx. 12 weeks after baseline)|"If a symptom was rated 0, it was considered nonexistent. For any other rating (1 to 10) the symptom was considered existent.
Only 92 patients showed this symptom."||participants|||Number
635144|NCT02651922|Secondary|Change of Symptom Transpiration (Pre - Post)|Symptom was assessed in a Likert scale ranging from 0 “no symptoms at all” to 10 “very severe symptoms”|Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline )|"If a symptom was rated 0, it was considered nonexistent. For any other rating (1 to 10) the symptom was considered existent.
Only 121 patients showed this symptom."||participants|||Number
635145|NCT02651922|Secondary|Change of Symptom Lack of Concentration (Pre - Post)|Symptom was assessed in a Likert scale ranging from 0 “no symptoms at all” to 10 “very severe symptoms”|Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)|"If a symptom was rated 0, it was considered nonexistent. For any other rating (1 to 10) the symptom was considered existent.
Only 142 patients showed this symptom."||participants|||Number
635146|NCT02651922|Secondary|Change of Symptom Fear (Pre - Post)|Symptom was assessed in a Likert scale ranging from 0 “no symptoms at all” to 10 “very severe symptoms”|Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)|"If a symptom was rated 0, it was considered nonexistent. For any other rating (1 to 10) the symptom was considered existent.
Only 133 patients showed this symptom."||participants|||Number
635147|NCT02651922|Secondary|Change of Symptom Exhaustion (Pre - Post)|Symptom was assessed in a Likert scale ranging from 0 “no symptoms at all” to 10 “very severe symptoms”|Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)|"If a symptom was rated 0, it was considered nonexistent. For any other rating (1 to 10) the symptom was considered existent.
Only 145 patients showed this symptom."||participants|||Number
635148|NCT02651922|Secondary|Change of Symptom Sleep Disturbance (Pre - Post)|Symptom was assessed in a Likert scale ranging from 0 “no symptoms at all” to 10 “very severe symptoms”|Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)|"If a symptom was rated 0, it was considered nonexistent. For any other rating (1 to 10) the symptom was considered existent.
Only 146 patients showed this symptom."||participants|||Number
635149|NCT02651922|Primary|Change of Symptom Inner Restlessness (Pre - Post)|Symptom was assessed in a Likert scale ranging from 0 “no symptoms at all” to 10 “very severe symptoms”|Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)|"If a symptom was rated 0, it was considered nonexistent. For any other rating (1 to 10) the symptom was considered existent.
Only 146 patients showed this symptom."||participants|||Number
635150|NCT02651467|Secondary|Change From Baseline in Visual Rating Scale (VRS) at Week 4 and 8|Participants rated the intensity of their response to the evaporative (air) stimulus using a 10 point VRS. The subjects were asked to rate their pain on a scale of 1 (“No Pain”) to 10 (“Intense Pain”).|Baseline, Week 4 and 8|"Intent-to-treat (ITT) population (N=218), defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.
Note: Baseline population only includes those subjects who have a corresponding post-baseline assessment."||Score on a scale||Standard Deviation|Mean
635151|NCT02651467|Secondary|Change From Baseline in Tactile Threshold at Week 4 and 8|Pressure was administered using a constant pressure probe (Yeaple Probe). The constant pressure probe allows the examiner to vary the force applied to the dentine surface from 10 g to an upper threshold of 80g in increments of 10 g. The tactile threshold is the maximum pressure applied without the participant reporting pain or discomfort. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold. The greater the tactile threshold, the less sensitive the tooth.|Baseline, Week 4 and 8|"Intent-to-treat (ITT) population (N=218), defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.
Note: Baseline population only includes those subjects who have a corresponding post-baseline assessment."||grams||Standard Deviation|Mean
635152|NCT02651467|Secondary|Change From Baseline in Schiff Sensitivity Score at Week 4|Schiff sensitivity score was assessed as participant’s response to an evaporative (air) stimulus after the stimulation of each individual tooth, using scale range of 0-3; 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of syimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3=Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.|Baseline and Week 4|Intent-to-treat (ITT) population (N=218), defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.||Score on scale||Standard Deviation|Mean
635207|NCT02644356|Secondary|Perceived Course Relevance: Potential of Course to Contribute to Improved Patient Care|"Investigator-generated scale of perceived importance and relevance of course content: To what degree do you think this course could potentially contribute to improved patient care? Likert scale ranges from 1 (not at all) to 4 (extremely)."|30 day follow-up|There was missing data for one subject for this item.||units on a scale||Standard Deviation|Mean
639814|NCT02371759|Primary|Diastolic Blood Pressure at 15 Minutes|Diastolic blood pressure values 10 minutes after local anesthesia injection|15th minute|||milimeters of Hg||Standard Deviation|Mean
635153|NCT02651467|Secondary|Change From Baseline in Schiff Sensitivity Score at Week 8 (Treatment 1 vs. Treatment 2)|Schiff sensitivity score was assessed by participant’s response to an evaporative (air) stimulus after the stimulation of each individual tooth, response of participant was scored using Schiff sensitivity scale range of 0-3; 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.|Baseline and Week 8|Intent-to-treat (ITT) population (N=218), defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy. Data shown for Treatment 1& 2 only for this endpoint. Baseline data only includes those participants who have a corresponding post-baseline assessment.||Score on a scale||Standard Deviation|Mean
635154|NCT02651467|Primary|Change From Baseline in Schiff Sensitivity Score at Week 8 (Treatment 1 and 2 Versus [vs.] Placebo)|Schiff sensitivity score was assessed by participant’s response to an evaporative (air) stimulus after the stimulation of each individual tooth, response of participant was scored using Schiff sensitivity scale range of 0-3; 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.|Baseline and Week 8|Intent-to-treat (ITT) population (N=218), defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy. This analysis was conducted on ITT population. Baseline data only includes those participants who have a corresponding post-baseline assessment.||Score on scale||Standard Deviation|Mean
635155|NCT02650440|Secondary|Berg Scale|Berg Scale is a functional scale of equilibrium performance, based on 14 common everyday items that evaluate the static and dynamic balance. The maximum scale score is 56 and each scale item has five alternatives ranging from 0 to 4 points. A score below 45 is considered a fall risk. This study comparede the change in the balance control applied scale after intervention as compared to baseline.|Baseline and 6 weeks|||units on a scale||Standard Error|Mean
635156|NCT02650440|Secondary|Lower Limbs Fugl-Meyer|"The Fugl Meyer Scale is a cumulative numerical scoring system that is assessed by an individual: range of motion, pain, tenderness, upper and lower extremity motor function and balance, plus coordination and speed of movement, with total 226 points. A three-point ordinal scale is applied to each item: 0 - can not be performed, 1-performed partially and 2-performed completely. For this study it was only an evaluation of motor function of the extremity of lower limbs with a total score of 0 to 34 points. The lower score indicates greater motor impairment.
This study compared the change in motor function of lower limbs applied scale after intervention as compared to baseline"|Baseline and 6 weeks|||units on a scale||Standard Error|Mean
635157|NCT02650440|Secondary|Ten-meters Walking Test (10MWT)|Change in the time of the gait applied test after intervention as compared to baseline|Baseline and 6 weeks|||seconds||Standard Error|Mean
635158|NCT02650440|Secondary|Time Up and Go (TUG)|This test assesses the level of mobility of the individual to measure the time spent to get up from a chair, walk a distance of 3 meters, turn around and return. This study compared the change in the time of the gait applied test after intervention as compared to baseline.|Baseline and 6 weeks|||seconds||Standard Error|Mean
635159|NCT02650440|Secondary|Six-minute Walking Test (6MWT)|Change in distance of the gait applied test after intervention as compared to baseline|Baseline and 6 weeks|||meters||Standard Error|Mean
635160|NCT02650440|Primary|Functional Ambulation Scale (FAC)|"The Functional Ambulation Scale (FAC) assesses an individual's independence during gait and follows a six-level scale: 0 - Patient can not walk or ask for help from two or more people; 1 - Patient requires continuous support from a person who assists with weight and balance; 2 - Patient needs continuous or intermittent support from a person to help with balance and coordination; 3 - Patient required for a person without physical contact; 4 - Patient can walk independently on the floor, but requires help on stairs and ramps; 5 - Patient can walk independently.
This study compared the gait independence by the FAC between the two Arms, after intervention as compared to baseline."|Baseline and 6 weeks|||units on a scale||Inter-Quartile Range|Median
635161|NCT02650219|Secondary|Number of Patients With : Antinuclear and/or Anti-SSa and/or Anti-SSb and/or Anti-RNP and/or Anti-DNA and/or Anti-Sm and/or Anticardiolipid and/or Anti β2Gp1 and/or Antiganglioside Autoantibodies (Genetics Analyses From Blood Samples)|data available from biological analyses (blood samples)|baseline|antinuclear autoantibodies||participants|||Number
635162|NCT02650219|Secondary|Number of Patients With : Photosensitivity and/or Raynaud Phenomenon and/or Sicca Syndrome and/or Arthralgia and/or Arthritis and/or Thrombosis (Medical History and Questionnaire)|Features usually associated with auto immune disease- data available from medical record of the patients|Baseline||||||
635163|NCT02650219|Secondary|Number of Patients With : Splenectomy and/or Bone Events and/or Pulmonary Hypertension and/or Specific Treatment and Non-specific (Medical History,Physiological Parameters and Questionnaire)|data available from medical record of the patients|Baseline|splenectomy testing||participants|||Number
635164|NCT02650219|Primary|Number of Patients With GD Diagnosis Confirmed by : Enzyme Testing of acidβ-glucosidase Activity Activity <15% in Blood Leucocytes Completed When Necsssary by GB1 Mutation Analyses (Analyses From Samples)|"acidβ-glucosidase enzyme testing : a lower than 15% of mean normal activity is considered to be diagnostic.
Decreased enzyme levels will often be confirmed by genetic testing. Numerous different mutations occur; GB1 mutation analyses is sometimes necessary to confirm the diagnosis."|baseline|||participant|||Number
635179|NCT02649634|Secondary|Blood Pressure at End of the Behavioural Weight Loss Program, Week 12|A measure of systolic and diastolic blood pressure was taken in a standardized manner according to the Canadian Hypertension Education Program Guidelines (Hemmelgarn et al., 2006). Three different readings of blood pressure were taken at each time point (baseline and end of behavioural weight loss program), and the average of the three readings was taken as the measure of blood pressure for each time point.|Mean blood pressure at the end of the behavioural weight loss program (week 12)|The participant numbers above represent the number of people that were analyzed on this specific outcome measure, which varies outcome to outcome, and does not necessarily match the number of participants that completed interviews at various stages as listed in the Participant Flow Module.||mmHg||Standard Error|Mean
635165|NCT02649634|Secondary|Confidence for Change Ratings After the Second Motivational Interviewing or Attention Control Interview, Week 12|"Self-report ratings of confidence for change after the second motivational interview or attention control interview, on 11-point visual analogue scales (Miller & Rollnick, 2002). For the visual analogue scales, participants were asked to rate how confident they feel about succeeding with losing weight on a scale from 0 “not confident” to 10 was “very confident”. Thus lower scores reflect lower levels of confidence for change, and higher scores reflect higher levels of confidence for change. Their raw score from 0 to 10 on this measure was taken as their Confidence for Change rating score."|Confidence for change ratings measured immediately after the second MI or attention control interview (week 12)|The participant numbers above represent the number of people that were analyzed on this specific outcome measure, which varies outcome to outcome, and does not necessarily match the number of participants that completed interviews at various stages as listed in the Participant Flow Module.||scores on a scale||Standard Deviation|Mean
635166|NCT02649634|Secondary|Readiness for Change Ratings After the Second Motivational Interviewing or Attention Control Interview, Week 12|"Self-report ratings of readiness for change after the second motivational interview or attention control interview, on 11-point visual analogue scales (Miller & Rollnick, 2002). For the visual analogue scales, participants were asked to rate how ready they are to lose weight on a scale from 0 “not ready” to 10 was “very ready”. Thus lower scores reflect lower levels of readiness for change, and higher scores reflect higher levels of readiness for change. Their raw score from 0 to 10 on this measure was taken as their Readiness for Change rating score."|Readiness for change ratings measured immediately after the second MI or attention control interview (week 12)|The participant numbers above represent the number of people that were analyzed on this specific outcome measure, which varies outcome to outcome, and does not necessarily match the number of participants that completed interviews at various stages as listed in the Participant Flow Module.||scores on a scale||Standard Deviation|Mean
635167|NCT02649634|Secondary|Importance for Change Ratings After the Second Motivational Interview or Attention Control Interview, Week 12|"Self-report ratings of importance of change after the second motivational interview or attention control interview, on 11-point visual analogue scales (Miller & Rollnick, 2002). For the visual analogue scales, participants were asked to rate how important it is for them personally to lose weight on a scale from 0 “not important” to 10 was “very important”. Thus lower scores reflect lower levels of importance for change, and higher scores reflect higher levels of importance for change. Their raw score from 0 to 10 on this measure was taken as their Importance for Change rating score."|Importance of change ratings measured immediately after the second MI or attention control interview (week 12)|The participant numbers above represent the number of people that were analyzed on this specific outcome measure, which varies outcome to outcome, and does not necessarily match the number of participants that completed interviews at various stages as listed in the Participant Flow Module.||scores on a scale||Standard Deviation|Mean
635168|NCT02649634|Secondary|Confidence for Change Ratings After the First Motivational Interview or Attention Control Interview, Week 1- 2|"Self-report ratings of confidence for change after the first motivational interview or attention control interview, on 11-point visual analogue scales (Miller & Rollnick, 2002). For the visual analogue scales, participants were asked to rate how confident they feel about succeeding with losing weight on a scale from 0 “not confident” to 10 was “very confident”. Thus lower scores reflect lower levels of confidence for change, and higher scores reflect higher levels of confidence for change. Their raw score from 0 to 10 on this measure was taken as their Confidence for Change rating score."|Confidence for change ratings measured immediately after the first MI or attention control interview (week 1- 2)|||scores on a scale||Standard Deviation|Mean
635169|NCT02649634|Secondary|Readiness for Change Ratings After the First Motivational Interview or Attention Control Interview, Week 1 -2|"Self-report ratings of readiness for change after the first motivational interview or attention control interview, on 11-point visual analogue scales (Miller & Rollnick, 2002). For the visual analogue scales, participants were asked to rate how ready they are to lose weight on a scale from 0 “not ready” to 10 was “very ready”. Thus lower scores reflect lower levels of readiness for change, and higher scores reflect higher levels of readiness for change. Their raw score from 0 to 10 on this measure was taken as their Readiness for Change rating score."|Readiness for change ratings measured immediately after the first MI or attention control interview (week 1- 2)|||scores on a scale||Standard Deviation|Mean
635170|NCT02649634|Secondary|Importance of Change Ratings After the First Motivational Interview or Attention Control Interview, Week 1 - 2|"Self-report ratings of importance of change after the first motivational interview or attention control interview, on 11-point visual analogue scales (Miller & Rollnick, 2002). For the visual analogue scales, participants were asked to rate how important it is for them personally to lose weight on a scale from 0 “not important” to 10 was “very important”. Thus lower scores reflect lower levels of importance for change, and higher scores reflect higher levels of importance for change. Their raw score from 0 to 10 on this measure was taken as their Importance for Change rating score."|Importance of change ratings measured immediately after the first MI or attention control interview (week 1- 2)|||scores on a scale||Standard Deviation|Mean
635171|NCT02649634|Secondary|Self-efficacy for Engaging in Physical Activity After the Second Motivational Interviewing or Attention Control Interview, Week 12|Self-efficacy for engaging in physical activity was measured by the Exercise Self-Efficacy questionnaire (ESE; Nigg & Riebe, 2002). Participants rate their confidence that they could exercise on a 5-point Likert scale for six barriers to exercise (e.g., bad weather, stress, availability of equipment). Consists of a global score as well as four subscales: Eating Concern, Restraint, Shape Concern, and Weight Concern. The global score is obtained by summing the subscale scores and then dividing this sum by the number of subscales (i.e. four). Range is 0 - 6. Higher scores are indicative of greater eating disorder symptomatology (i.e., worse outcome).|Mean self-efficacy for engaging in physical activity measured immediately after the second MI or attention control interview (week 12)|The participant numbers above represent the number of people that were analyzed on this specific outcome measure, which varies outcome to outcome, and does not necessarily match the number of participants that completed interviews at various stages as listed in the Participant Flow Module.||ESE score||Standard Deviation|Mean
635232|NCT02643004|Secondary|Lens Surface - Wettability|Lens wettability for senofilcon A and stenfilcon A is assessed at 1 week. Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe|1 week|A protocol deviation occurred for 2 participants and therefore resulted in incomplete data sets.||percentage of subjects|||Number
635172|NCT02649634|Secondary|Self-efficacy Related to Eating Patterns After the Second Motivational Interviewing or Attention Control Interview, Week 12|Self-efficacy related to eating patterns was measured by the Weight Efficacy Life-Style Questionnaire (WEL; Clark, Abrams, Niaura, Eaton, & Rossi, 1991). This self-report questionnaire yields five subscale scores, which rate self-efficacy for controlling eating in different situations/dimensions: negative emotions, availability, social pressure, physical discomfort, and positive activities. A global/total score (which ranges from 0 - 180) is obtained by summing the scores of each of the five subscales. Higher scores are indicative of greater self-efficacy (i.e., higher scores = better outcome).|Mean self-efficacy related to eating patterns measured immediately after the second MI or attention control interview (week 12)|The participant numbers above represent the number of people that were analyzed on this specific outcome measure, which varies outcome to outcome, and does not necessarily match the number of participants that completed interviews at various stages as listed in the Participant Flow Module.||Global score on WEL||Standard Deviation|Mean
635173|NCT02649634|Secondary|Self-efficacy for Engaging in Physical Activity After the First Motivational Interviewing or Attention Control Interview, Week 1- 2|Self-efficacy for engaging in physical activity was measured by the Exercise Self-Efficacy questionnaire (ESE; Nigg & Riebe, 2002). Participants rate their confidence that they could exercise on a 5-point Likert scale for six barriers to exercise (e.g., bad weather, stress, availability of equipment). Consists of a global score as well as four subscales: Eating Concern, Restraint, Shape Concern, and Weight Concern. The global score is obtained by summing the subscale scores and then dividing this sum by the number of subscales (i.e. four). Range is 0 - 6. Higher scores are indicative of greater eating disorder symptomatology (i.e., worse outcome).|Mean self-efficacy for engaging in physical activity measured immediately after the first MI or attention control interview (week 1 - 2)|||ESE score||Standard Deviation|Mean
635174|NCT02649634|Secondary|Self-efficacy Related to Eating Patterns After the First Motivational Interviewing or Attention Control Interview, Week 1 - 2|Self-efficacy related to eating patterns was measured by the Weight Efficacy Life-Style Questionnaire (WEL; Clark, Abrams, Niaura, Eaton, & Rossi, 1991). This self-report questionnaire yields five subscale scores, which rate self-efficacy for controlling eating in different situations/dimensions: negative emotions, availability, social pressure, physical discomfort, and positive activities. A global/total score (which ranges from 0 - 180) is obtained by summing the scores of each of the five subscales. Higher scores are indicative of greater self-efficacy (i.e., higher scores = better outcome).|Mean self-efficacy related to eating patterns measured immediately after the first MI or attention control interview (week 1 to 2)|||Global score on WEL||Standard Deviation|Mean
635175|NCT02649634|Secondary|Eating Disorder Symptomology at 6 Month Follow up|Eating disorder symptomology was measured using the Eating Disorder Examination-Questionnaire (EDE-Q; Fairburn & Beglin, 1994). This self-report questionnaire assesses the presence and degree of specific psychopathology associated with eating disorders over the previous 28 days. Consists of a global score as well as four subscales: Eating Concern, Restraint, Shape Concern, and Weight Concern. The global score is obtained by summing the subscale scores and then dividing this sum by the number of subscales (i.e. four). Range is 0 - 6. Higher scores are indicative of greater eating disorder symptomatology (i.e., worse outcome).|Mean eating disorder symptomology as measured by the global EDE-Q score, 6 months after the end of the behavioural weight loss program|The participant numbers above represent the number of people that were analyzed on this specific outcome measure, which varies outcome to outcome, and does not necessarily match the number of participants that completed interviews at various stages as listed in the Participant Flow Module.||Global EDE-Q score||Standard Error|Mean
635176|NCT02649634|Secondary|Eating Disorder Symptomology at 1 Month Follow up|Eating disorder symptomology was measured using the Eating Disorder Examination-Questionnaire (EDE-Q; Fairburn & Beglin, 1994). This self-report questionnaire assesses the presence and degree of specific psychopathology associated with eating disorders over the previous 28 days. Consists of a global score as well as four subscales: Eating Concern, Restraint, Shape Concern, and Weight Concern. The global score is obtained by summing the subscale scores and then dividing this sum by the number of subscales (i.e. four). Range is 0 - 6. Higher scores are indicative of greater eating disorder symptomatology (i.e., worse outcome).|Mean eating disorder symptomology as measured by the global EDE-Q score, 1 month after the end of the behavioural weight loss program|The participant numbers above represent the number of people that were analyzed on this specific outcome measure, which varies outcome to outcome, and does not necessarily match the number of participants that completed interviews at various stages as listed in the Participant Flow Module.||Global EDE-Q score||Standard Error|Mean
635177|NCT02649634|Secondary|Eating Disorder Symptomology at End of the Behavioural Weight Loss Program, Week 12|Eating disorder symptomology was measured using the Eating Disorder Examination-Questionnaire (EDE-Q; Fairburn & Beglin, 1994). This self-report questionnaire assesses the presence and degree of specific psychopathology associated with eating disorders over the previous 28 days. Consists of a global score as well as four subscales: Eating Concern, Restraint, Shape Concern, and Weight Concern. The global score is obtained by summing the subscale scores and then dividing this sum by the number of subscales (i.e. four). Range is 0 - 6. Higher scores are indicative of greater eating disorder symptomatology (i.e., worse outcome).|Mean eating disorder symptomology as measured by the global EDE-Q score, at the end of the behavioural weight loss program (week 12)|The participant numbers above represent the number of people that were analyzed on this specific outcome measure, which varies outcome to outcome, and does not necessarily match the number of participants that completed interviews at various stages as listed in the Participant Flow Module.||Global EDE-Q score||Standard Error|Mean
635178|NCT02649634|Secondary|Blood Pressure at 6 Month Follow up|A measure of systolic and diastolic blood pressure was taken in a standardized manner according to the Canadian Hypertension Education Program Guidelines (Hemmelgarn et al., 2006). Three different readings of blood pressure were taken at each time point (baseline and 6 month follow up), and the average of the three readings was taken as the measure of blood pressure for each time point.|Mean blood pressure 6 months after the end of the behavioural weight loss program|The participant numbers above represent the number of people that were analyzed on this specific outcome measure, which varies outcome to outcome, and does not necessarily match the number of participants that completed interviews at various stages as listed in the Participant Flow Module.||mmHg||Standard Error|Mean
635233|NCT02643004|Secondary|Lens Surface - Wettability|Lens wettability for senofilcon A and stenfilcon A is assessed at baseline. Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe|Baseline|||percentage of subjects|||Number
635180|NCT02649634|Secondary|Dietary Behaviour at 6 Month Follow up|Dietary behaviour was measured by the Fat-related Dietary Habits Questionnaire (DHQ; Kristal, Shattuck, & Henry, 1990). This self-report questionnaire assesses dietary behaviours and high-fat eating patterns and consists of an overall summary score and five subscale scores assessing different dimensions of fat-related dietary habits. The DHQ consists of an overall summary score and five subscale scores assessing different dimensions of fat-related dietary habits. The overall summary score is the mean of all non-missing subscales scores. Responses are scored on a 4-point scale (usually, often, sometimes, rarely/never). Range of overall summary score is 1 - 4. Higher scores correspond to higher fat intakes (i.e., higher scores = worse outcome).|Mean dietary behaviour score as measured by the overall DHQ score, 6 months after the end of the behavioural weight loss program|The participant numbers above represent the number of people that were analyzed on this specific outcome measure, which varies outcome to outcome, and does not necessarily match the number of participants that completed interviews at various stages as listed in the Participant Flow Module.||Overall score on DHQ||Standard Error|Mean
635181|NCT02649634|Secondary|Dietary Behaviour at 1 Month Follow up|Dietary behaviour was measured by the Fat-related Dietary Habits Questionnaire (DHQ; Kristal, Shattuck, & Henry, 1990). This self-report questionnaire assesses dietary behaviours and high-fat eating patterns and consists of an overall summary score and five subscale scores assessing different dimensions of fat-related dietary habits. The DHQ consists of an overall summary score and five subscale scores assessing different dimensions of fat-related dietary habits. The overall summary score is the mean of all non-missing subscales scores. Responses are scored on a 4-point scale (usually, often, sometimes, rarely/never). Range of overall summary score is 1 - 4. Higher scores correspond to higher fat intakes (i.e., higher scores = worse outcome).|Mean dietary behaviour score as measured by the overall DHQ score, 1 month after the end of the behavioural weight loss program|The participant numbers above represent the number of people that were analyzed on this specific outcome measure, which varies outcome to outcome, and does not necessarily match the number of participants that completed interviews at various stages as listed in the Participant Flow Module.||Overall score on DHQ||Standard Error|Mean
635182|NCT02649634|Secondary|Dietary Behaviour at End of the Behavioural Weight Loss Program, Week 12|Dietary behaviour was measured by the Fat-related Dietary Habits Questionnaire (DHQ; Kristal, Shattuck, & Henry, 1990). This self-report questionnaire assesses dietary behaviours and high-fat eating patterns and consists of an overall summary score and five subscale scores assessing different dimensions of fat-related dietary habits. The DHQ consists of an overall summary score and five subscale scores assessing different dimensions of fat-related dietary habits. The overall summary score is the mean of all non-missing subscales scores. Responses are scored on a 4-point scale (usually, often, sometimes, rarely/never). Range of overall summary score is 1 - 4. Higher scores correspond to higher fat intakes (i.e., higher scores = worse outcome).|Mean dietary behaviour score as measured by the overall DHQ score, at the end of the behavioural weight loss program (week 12)|The participant numbers above represent the number of people that were analyzed on this specific outcome measure, which varies outcome to outcome, and does not necessarily match the number of participants that completed interviews at various stages as listed in the Participant Flow Module.||overall score on DHQ||Standard Error|Mean
635183|NCT02649634|Secondary|Physical Activity at 6 Month Follow up|Physical activity was measured by the Paffenbarger questionnaire (PPAQ; Paffenbarger, Wing, & Hyde, 1978). This self-report questionnaire assesses amount of activity performed during a typical week, and consists of three components: (1) stair climbing, (2) walking, and (3) sports and recreation. Participants were asked to report the frequency and duration of physical activity in the past week. Participants report the frequency and duration of physical activity in the past week. Scoring yields energy expenditure from physical activity per week (kcal/kg/week). Higher scores translate into greater energy expenditure per week (i.e.,better outcome). Range is 0 - no theoretical maximum. Highest observed score in our study was 10902 kcal/kg/week.|Mean physical activity as measured by the PPAQ, 6 months after the end of the behavioural weight loss program|The participant numbers above represent the number of people that were analyzed on this specific outcome measure, which varies outcome to outcome, and does not necessarily match the number of participants that completed interviews at various stages as listed in the Participant Flow Module.||kilocalories per week||Standard Error|Mean
635184|NCT02649634|Secondary|Physical Activity at 1 Month Follow up|Physical activity was measured by the Paffenbarger questionnaire (PPAQ; Paffenbarger, Wing, & Hyde, 1978). This self-report questionnaire assesses amount of activity performed during a typical week, and consists of three components: (1) stair climbing, (2) walking, and (3) sports and recreation. Participants were asked to report the frequency and duration of physical activity in the past week. Participants report the frequency and duration of physical activity in the past week. Scoring yields energy expenditure from physical activity per week (kcal/kg/week). Higher scores translate into greater energy expenditure per week (i.e.,better outcome). Range is 0 - no theoretical maximum. Highest observed score in our study was 10902 kcal/kg/week.|Mean physical activity as measured by the PPAQ, 1 month after the end of the behavioural weight loss program|The participant numbers above represent the number of people that were analyzed on this specific outcome measure, which varies outcome to outcome, and does not necessarily match the number of participants that completed interviews at various stages as listed in the Participant Flow Module.||kilocalories per week||Standard Error|Mean
635185|NCT02649634|Secondary|Physical Activity at End of the Behavioural Weight Loss Program, Week 12|Physical activity was measured by the Paffenbarger questionnaire (PPAQ; Paffenbarger, Wing, & Hyde, 1978). This self-report questionnaire assesses amount of activity performed during a typical week, and consists of three components: (1) stair climbing, (2) walking, and (3) sports and recreation. Participants were asked to report the frequency and duration of physical activity in the past week. Participants report the frequency and duration of physical activity in the past week. Scoring yields energy expenditure from physical activity per week (kcal/kg/week). Higher scores translate into greater energy expenditure per week (i.e.,better outcome). Range is 0 - no theoretical maximum. Highest observed score in our study was 10902 kcal/kg/week.|Mean physical activity as measured by the PPAQ, at the end of the behavioural weight loss program (week 12)|The participant numbers above represent the number of people that were analyzed on this specific outcome measure, which varies outcome to outcome, and does not necessarily match the number of participants that completed interviews at various stages as listed in the Participant Flow Module.||kilocalories per week||Standard Error|Mean
639815|NCT02371759|Primary|Diastolic Blood Pressure at 10 Minutes|Diastolic blood pressure values 5 minutes after local anesthesia injection|10th minute|||milimeters of Hg||Standard Deviation|Mean
635186|NCT02649634|Secondary|BMI at 6 Month Follow up|A digital scale (Tanita BWB-800S), which assessed weight to the nearest 0.1 kg, was used to assess weight for the 6 month follow up assessment, and the height measured at the beginning of the behavioural weight loss program was used to calculate BMI. BMI was calculated as weight in Kilograms divided by height in meter squared.|Mean BMI 6 months after the end of the behavioural weight loss program|The participant numbers above represent the number of people that were analyzed on this specific outcome measure, which varies outcome to outcome, and does not necessarily match the number of participants that completed interviews at various stages as listed in the Participant Flow Module.||kg/m2||Standard Error|Mean
635187|NCT02649634|Secondary|BMI at End of Behavioural Weight Loss Program, Week 12|Weight was measured to the nearest 0.1 kg using a balance beam scale, height was measured to the nearest 0.1 cm using a stadiometer at the beginning of the behavioural weight loss program. BMI was calculated as weight in Kilograms divided by height in meters squared.|Mean BMI at the end of the behavioural weight loss program (week 12)|The participant numbers above represent the number of people that were analyzed on this specific outcome measure, which varies outcome to outcome, and does not necessarily match the number of participants that completed interviews at various stages as listed in the Participant Flow Module.||kg/m2||Standard Error|Mean
635188|NCT02649634|Secondary|Adherence|The mean number of missed behavioural weight loss sessions (out of 24 sessions)|Assessed once at the end of the behavioural weight loss program (week 12)|||number of group sessions||Standard Deviation|Mean
635189|NCT02649634|Secondary|Weight at 6 Month Follow up|a digital scale (Tanita BWB-800S), which assessed weight to the nearest 0.1 kg, was used for the 6 month follow-up assessment|Mean weight 6 months after the end of the behavioural weight loss program|The participant numbers above represent the number of people that were analyzed on this specific outcome measure, which varies outcome to outcome, and does not necessarily match the number of participants that completed interviews at various stages as listed in the Participant Flow Module.||kilograms||Standard Error|Mean
635190|NCT02649634|Primary|Weight at End of Behavioural Weight Loss Program, 12 Weeks|Weight was measured to the nearest 0.1 kg using a balance beam scale|Mean weight recorded at the end of the behavioural weight loss program (week 12)|The participant numbers above represent the number of people that were analyzed on this specific outcome measure, which varies outcome to outcome, and does not necessarily match the number of participants that completed interviews at various stages as listed in the Participant Flow Module.||kilograms||Standard Error|Mean
635191|NCT02648438|Secondary|Area Under Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC)|For oral and inhalation administrations: pre-dose (0 hour) and post-dose at 15, 30 and 45 minutes and 1.0, 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 36.0, 48.0, 72.0 and 96.0 hours following the administration of the investigational product AZD7594. For IV administration: pre-dose (0 hour) and post-dose at 5, 10, 15 (end of infusion), 30, 45, 60 and 90 minutes and 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 48.0, 72.0 and 96.0 hours following the start of the IV infusion of the investigational product AZD7594|0-96 hours|The PK analysis set will consist of all subjects in the safety analysis set for whom at least 1 PK parameters can be calculated for at least 1 treatment period and who have no major protocol deviations thought to impact on the analysis of the PK data.||(h*pmol/L)||Geometric Coefficient of Variation|Geometric Mean
635192|NCT02648438|Secondary|Oral Bioavailability After Inhaled Treatment (F Oral)|For oral and inhalation administrations: pre-dose (0 hour) and post-dose at 15, 30 and 45 minutes and 1.0, 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 36.0, 48.0, 72.0 and 96.0 hours following the administration of the investigational product AZD7594. For IV administration: pre-dose (0 hour) and post-dose at 5, 10, 15 (end of infusion), 30, 45, 60 and 90 minutes and 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 48.0, 72.0 and 96.0 hours following the start of the IV infusion of the investigational product AZD7594|0-96 hours|The PK analysis set will consist of all subjects in the safety analysis set for whom at least 1 PK parameters can be calculated for at least 1 treatment period and who have no major protocol deviations thought to impact on the analysis of the PK data.||Percentage||Geometric Coefficient of Variation|Geometric Mean
635193|NCT02648438|Secondary|Absolute Systemic Bioavailability After Inhalation (F Inhalation, Total)|For oral and inhalation administrations: pre-dose (0 hour) and post-dose at 15, 30 and 45 minutes and 1.0, 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 36.0, 48.0, 72.0 and 96.0 hours following the administration of the investigational product AZD7594. For IV administration: pre-dose (0 hour) and post-dose at 5, 10, 15 (end of infusion), 30, 45, 60 and 90 minutes and 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 48.0, 72.0 and 96.0 hours following the start of the IV infusion of the investigational product AZD7594|0-96 hours|The PK analysis set will consist of all subjects in the safety analysis set for whom at least 1 PK parameters can be calculated for at least 1 treatment period and who have no major protocol deviations thought to impact on the analysis of the PK data.||Percentage||Geometric Coefficient of Variation|Geometric Mean
635194|NCT02648438|Secondary|Area Under the Plasma Concentration-curve From Time Zero to Time of Last Quantifiable Concentration (AUC0-t)|For oral and inhalation administrations: pre-dose (0 hour) and post-dose at 15, 30 and 45 minutes and 1.0, 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 36.0, 48.0, 72.0 and 96.0 hours following the administration of the investigational product AZD7594. For IV administration: pre-dose (0 hour) and post-dose at 5, 10, 15 (end of infusion), 30, 45, 60 and 90 minutes and 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 48.0, 72.0 and 96.0 hours following the start of the IV infusion of the investigational product AZD7594|0-96 hours|The PK analysis set will consist of all subjects in the safety analysis set for whom at least 1 PK parameters can be calculated for at least 1 treatment period and who have no major protocol deviations thought to impact on the analysis of the PK data.||(h*pmol/L)||Geometric Coefficient of Variation|Geometric Mean
635195|NCT02648438|Secondary|Observed Maximum Plasma Concentration (Cmax)|For oral and inhalation administrations: pre-dose (0 hour) and post-dose at 15, 30 and 45 minutes and 1.0, 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 36.0, 48.0, 72.0 and 96.0 hours following the administration of the investigational product AZD7594. For IV administration: pre-dose (0 hour) and post-dose at 5, 10, 15 (end of infusion), 30, 45, 60 and 90 minutes and 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 48.0, 72.0 and 96.0 hours following the start of the IV infusion of the investigational product AZD7594|0-96 hours|The PK analysis set will consist of all subjects in the safety analysis set for whom at least 1 PK parameters can be calculated for at least 1 treatment period and who have no major protocol deviations thought to impact on the analysis of the PK data.||pmol/L||Geometric Coefficient of Variation|Geometric Mean
639816|NCT02371759|Primary|Baseline Diastolic Blood Pressure||baseline, 0 minutes|||milimeters of Hg||Standard Deviation|Mean
635196|NCT02648438|Secondary|PK of AZD7594 Following Oral Administration by Assessment of the Absolute Systemic Bioavailability After Oral Administration (Fpo)|For oral and inhalation administrations: pre-dose (0 hour) and post-dose at 15, 30 and 45 minutes and 1.0, 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 36.0, 48.0, 72.0 and 96.0 hours following the administration of the investigational product AZD7594. For IV administration: pre-dose (0 hour) and post-dose at 5, 10, 15 (end of infusion), 30, 45, 60 and 90 minutes and 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 48.0, 72.0 and 96.0 hours following the start of the IV infusion of the investigational product AZD7594|0-96 hours|The PK analysis set will consist of all subjects in the safety analysis set for whom at least 1 PK parameters can be calculated for at least 1 treatment period and who have no major protocol deviations thought to impact on the analysis of the PK data.||Percentage||Geometric Coefficient of Variation|Geometric Mean
635197|NCT02648438|Primary|Pharmacokinetics (PK) of AZD7594 Delivered by Monodose Inhaler and Multiple-dose DPI or pMDI in Terms of Pulmonary Bioavailability After Inhalation (Fpulmonary)|For oral and inhalation administrations: pre-dose (0 hour) and post-dose at 15, 30 and 45 minutes and 1.0, 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 36.0, 48.0, 72.0 and 96.0 hours following the administration of the investigational product AZD7594. For IV administration: pre-dose (0 hour) and post-dose at 5, 10, 15 (end of infusion), 30, 45, 60 and 90 minutes and 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 48.0, 72.0 and 96.0 hours following the start of the IV infusion of the investigational product AZD7594|0-96 hours|The PK analysis set will consist of all subjects in the safety analysis set for whom at least 1 PK parameters can be calculated for at least 1 treatment period and who have no major protocol deviations thought to impact on the analysis of the PK data.||Percentage||Geometric Coefficient of Variation|Geometric Mean
635198|NCT02648022|Secondary|Percentage of Participants That Completed Planned Duration of Treatment Using a Cutoff of 80%|Patients were considered to have completed treatment if they a) were prescribed and received the full course of antiviral treatment recommended by their HCV physician, and b) had at least one medical record note stating they had completed treatment.|up to 24 weeks|||percentage of participants|||Number
635199|NCT02648022|Secondary|Percentage of Participants With Treatment Initiation and Completion|The main secondary outcomes for the study include rates of Interferon-based treatment initiation and completion. Treatment data from the HCV clinics were reviewed for each patient at each site. Participants who a) filled at least one prescription for Interferon and ribavirin, and b) had at least one treatment-related physician visit with a medical record note stating they began taking the medications were deemed to have initiated antiviral treatment. Patients were considered to have completed treatment if they a) were prescribed and received the full course of antiviral treatment recommended by their HCV physician, and b) had at least one medical record note stating they had completed treatment.|up to 24 weeks|||percentage of Particpants|||Number
635200|NCT02648022|Primary|Sustained Viral Response (SVR)|The primary outcome for the study was the proportion of patients that achieve an SVR. Patient adherence to completing the prescribed therapy and SVR were both tracked with medical records. Viral load at 4, 12-and 24-weeks during treatment initiation have been shown to predict final SVR. Final SVR data consists of viral tests conducted at 6 months after the termination of therapy.|up to 24 weeks|||percentage of Participants|||Number
635201|NCT02646449|Primary|Level of Depressive Symptoms|Level of depressive symptoms, as indicated by the score on the Beck Depression Inventory. The Beck Depression Inventory II scoring range is as follows: 0-13 minimal depressive symptoms, 14-19 mild depressive symptoms, 20-28 moderate depressive symptoms and 29-63 severe depressive symptoms.|12 Weeks|||units on a scale||Standard Deviation|Mean
635202|NCT02646449|Primary|Drinks Per Drinking Day|Level of drinking, as indicated by the number of drinks per day as recorded on the Timeline Follow-Back calendar.|12 Weeks|||Drinks per drinking day||Standard Deviation|Mean
635203|NCT02645760|Secondary|Change From Baseline in Repositioning Error on Repositioning Test at Week 7|This test was performed by measuring how accurately the participant during sitting that could reposition the lumbar spine into the former lumbar position, after change position in the sagittal plane. The procedure use a laser pointer adjusted to be level, was positioned to have the mark line directly on 0 cm. After having actively moved around, in maximum flexion-extension and return to neutral position, the laser line on the tape-measure, the deviation from the 0 point was measured in centimeter. change = (baseline score - week 7 score)|baseline and week 7|Analysis of covariance (ANCOVA) was performed to compare differences between groups for outcome measures. To estimate the adjusted mean differences and the 95% confidence intervals for each outcome measure of each group||centimeter||Standard Deviation|Mean
635204|NCT02645760|Secondary|Change From Baseline in Back Range of Motion (Flexion) on Modified-modified Schober’s Test at Week 7|Modified-modified Schober’s test used a tape measure held directly over the spine between points 15 cm above the posterior superior iliac spine (PSIS) with the participant in the neutral standing position on the foot print. The participant was asked to stand with knees locked and bend forward (lumbar flexion) as far as possible without pain; the increase in distance between the marks gave an estimate of lumbar ROM. change =(baseline score - week 7 score)|baseline and week 7|Analysis of covariance (ANCOVA) was performed to compare differences between groups for outcome measures. To estimate the adjusted mean differences and the 95% confidence intervals for each outcome measure of each group||centimeter||Standard Deviation|Mean
635205|NCT02645760|Secondary|Change From Baseline in Functional Disability on Roland-Morris Disability Questionnaire at Week 7|This outcome was assessed by the Roland-Morris disability questionnaire (RMDQ) Thai version that is designed to assess self-rated physical disability caused by LBP. This questionnaire has 24 items. The participant put a tick on the statement when it applies to him that specific day. The scores range from 0 (no disability) to 24 (maximum disability). change = (baseline score - week 7 score|baseline and week 7|Analysis of covariance (ANCOVA) was performed to compare differences between groups for outcome measures. To estimate the adjusted mean differences and the 95% confidence intervals for each outcome measure of each group||units on a scale||Standard Deviation|Mean
635206|NCT02645760|Primary|Change From Baseline in Pain on 11- Point Numerical Rating Scale at Week 7|The 11 point numerical rating scale (11-NRS) is a method to measure pain intensity. The zero represents no pain while 10 represent the worst imaginable pain.The patient is asked to cross or circle a score that the best represents the pain intensity. Change = (week 7 score - baseline score)|baseline an week 7|Analysis of covariance (ANCOVA) was performed to compare differences between groups for outcome measures. To estimate the adjusted mean differences and the 95% confidence intervals for each outcome measure of each group.||units on a scale||Standard Deviation|Mean
635208|NCT02644356|Secondary|Perceived Course Relevance: Increasing Knowledge of Non-pharmacological Approaches|"Investigator-generated scale of perceived importance and relevance of course content: How relevant is the content of this course for increasing palliative care providers' knowledge of non-pharmacological approaches? Likert scale ranges from 1 (not at all) to 4 (extremely)."|30 day follow-up|There was missing data for one subject for this item.||units on a scale||Standard Deviation|Mean
635209|NCT02644356|Secondary|Perceived Course Relevance: Importance of Knowledge About Non-pharmacological Approaches|"Investigator-generated scale of perceived importance and relevance of course content: How important is it for palliative care providers to know about non-pharmacological approaches to symptom management? Likert scale ranges from 1 (not at all) to 4 (extremely)."|30 day follow-up|There was missing data for one subject for this item.||units on a scale||Standard Deviation|Mean
635210|NCT02644356|Secondary|Change in Ratings of Confidence in Explaining the Modality From Baseline to 30 Days|Investigator-generated scale of confidence in communicating about the modality to patients, families and colleagues in PC contexts. Likert-scaled items ranging from 0-10, with 0 as lowest and 10 as highest.|Baseline, 30 days|There was missing data for one subject for this item.||units on a scale||Standard Deviation|Mean
635211|NCT02644356|Secondary|Change in Ratings of Confidence in Making Evidence-based Recommendations for the Modality in PC Planning From Baseline to 30 Days|Investigator-generated scale of confidence in making evidence-based recommendations about the modality. Likert-scaled items ranging from 0-10, with 0 as lowest and 10 as highest.|Baseline, 30 days|There was missing data for one subject for this item.||units on a scale||Standard Deviation|Mean
635212|NCT02644356|Secondary|Change in Ratings of Confidence in Understanding a Modality's Safety Considerations in PC From Baseline to 30 Days|Investigator-generated scale of confidence in understanding modality safety considerations. Likert-scaled items ranging from 0-10, with 0 as lowest and 10 as highest.|Baseline, 30 days|There was missing data for one subject for this item.||units on a scale||Standard Deviation|Mean
635213|NCT02644356|Primary|Change in Test Scores on Knowledge of Course Content From Baseline to 30 Days|Investigator-generated test of change in knowledge about theory, mechanisms of action, delivery, indications for use, evidence of efficacy; total of 45 multiple choice questions covering three modalities: acupuncture, massage, and music interventions. Range of total possible correct responses was from 0-45, with subscores as follows: range for acupuncture, 0-15; massage, 0-16; music interventions, 0-14. Total score is the sum of the combined subscores.|Baseline, 30 days|Disciplines: Nursing, 22; physician, 11; social work, 13; chaplaincy, 4; administrators, 4; counseling/psychology, 2 (some reported more than one discipline).||units on a scale||Standard Deviation|Mean
635214|NCT02643251|Secondary|Mean Daily Worst Pain Intensity Numeric Pain Rating Scale Scores|The Numeric Pain Rating Scale is a single reading that measures the patients interpretation of their pain on a scale from 0, no pain to 10, worst pain imaginable. The change from baseline can range from -10 to 10. The change from Baseline (worse score from Day -14 to Day -8) to End-of-Treatment (worse score during Days 78 to 84 [±3 days]) in the Numeric Pain Rating Scale score assessing the “worse pain in the past 24 hours in the painful areas of the feet” from Days 78 to 84 compared to the 7 days at the Baseline Phase (Days -14 to -8). For the primary efficacy endpoint, the mean change in pain intensity from Baseline to Week 12 was analyzed using an analysis of covariance (ANCOVA) model with the Baseline pain intensity score serving as a covariate. The statistical model also included treatment, site, site by treatment interaction, and strata. If the site by treatment interaction term was not significant at the 0.1 level, then it was excluded from the model.|The change from Baseline (worse over Day -14 to Day -8) to End-of-Treatment (worse over Days 78 to 84 [±3 days])|||units on a scale||Standard Deviation|Mean
635215|NCT02643251|Primary|Change From Baseline to Day 84 (Week 12) in Numeric Pain Rating Scale Score|The Numeric Pain Rating Scale is a single reading that measures the patients interpretation of their pain on a scale from 0, no pain to 10, worst pain imaginable. The change from baseline can range from -10 to 10. The change from Baseline (averaged over Day -14 to Day -8) to End-of-Treatment (averaged over Days 78 to 84 [±3 days]) in the Numeric Pain Rating Scale score assessing the “average pain in the past 24 hours in the painful areas of the feet” averaged over Days 78 to 84 compared to the 7 days at the Baseline Phase (Days -14 to -8). For the primary efficacy endpoint, the mean change in pain intensity from Baseline to Week 12 was analyzed using an analysis of covariance (ANCOVA) model with the Baseline pain intensity score serving as a covariate. The statistical model also included treatment, site, site by treatment interaction, and strata. If the site by treatment interaction term was not significant at the 0.1 level, then it was excluded from the model.|The change from Baseline (averaged over Day -14 to Day -8) to End-of-Treatment (averaged over Days 78 to 84 [±3 days])|||units on a scale||Standard Deviation|Mean
635216|NCT02645123|Primary|Change in the 3 Dimensional Gait Characteristics (Kinetic and Kinematic) (Motion Analysis Optoelectronic Gait Analysis System Along With 2 Kistler Force Platforms)|The data was recorded using relevant software (Cortex, Calcium Solver, Skeleton Builder, DV Reference, Sky Scripting, KinTools RT). Κinetic and kinematic data were assessed and analysed at 3 different gait cycle time moments defined by the gait cycle and the amount of ground reaction force (GRF) during both left and right foot contact: moment 1 (T1) was at maximum GRF during heel strike, moment 2 (T2) at minimum GRF during mid stance, and moment 3 (T3) at maximum GRF during acceleration before toe off (http://www.oandplibrary.org/popup.asp?frmItemId=2A1E740F-13FD-4A68-B8A3-83A407795B5F&frmType=image&frmId=1). From these, we extrapolated the quotient (between R and L kinetic and kinematic data) values. A value of 1 would mean absolute symmetry between left and right side (Seliktar and Mizrahi, 1986). the participants walked for 10 times and the mean values of the best 3 measurements were used for analysis.|before the beginning and after the end of 5 weeks for each patient|all participants were chronic low back pain patients with a variable degree of vertebral disc degeneration defined by the modified Pfirrmann scale||quotient: degrees/degrees=no unit||Standard Deviation|Mean
635217|NCT02645123|Primary|Change in the Roland-Morris Disability Questionnaire|"The Roland-Morris Disability Questionnaire is designed to assess self-rated physical disability caused by low back pain. The Roland-Morris Disability Questionnaire is most sensitive for patients with mild to moderate disability due to acute, sub-acute or chronic low back pain.
For patients with severe disability the Oswestry disability questionnaire is recommended. in this case, we used the 24 question version in which 0 means no disability and 24 means total disability."|before the beginning, after the end of 5 weeks for each patient and 6 months after the last treatment session for each patient|||units on a scale||Standard Deviation|Mean
635218|NCT02645123|Primary|Change in the Oswestry Low Back Pain Disability Index|this is a self rated questionnaire that is expressed in a percentage with 0% meaning no disability and 100% meaning total disability. The minimum detectable change is reported to be 10% points|before the beginning, after the end of 5 weeks for each patient and 6 months after the last treatment session for each patient|||units on a scale||Standard Deviation|Mean
635219|NCT02645123|Primary|Change in the Numerical Pain Rating Scale|this scale expresses the self rated pain levels in a 0 to 10 range with 0 meaning no pain and 10 the worst imaginable pain.|before the beginning, after the end of 5 weeks and 6 months after the last treatment session for each patient|||units on a scale||Standard Deviation|Mean
635220|NCT02644109|Primary|Serum LDL Cholesterol||1 month|||mg/dl||Standard Deviation|Mean
635221|NCT02644096|Primary|Change in Physical Dimensions in Health Status of Elderly Patients From 4 Weeks Pre Operatively to 9 Months Post Operatively After THR. Health Status is Measured by the Questionnaire Short-form 36 (SF-36).|"The health status was assessed by Short-Form 36 (SF-36) which is a self-administered generic questionnaire that has been shown to be reliable and valid for measuring functioning, well-being and general health status. The instrument measures the eight health dimensions listed in figure 3. Reflecting the impact of both dysfunctions and general health perception the questionnaire measures: physical function (PF), role physical (RF), bodily pain (BP), social function (SF) role emotional (RE), general health (GH), vitality (VT) and mental health (MH). The questions related to each dimension are scored on a scale from 0 (worst score) to 100 (best score).
All patients who had been consecutively admitted for THR were mailed an introduction letter together with a questionnaire containing a number and a prepaid return envelope. In the questionnaire they were asked to give demographic data and assess their health status"|Four weeks preoperatively and nine moths after discharge.|Patients who have completed the study and contributed with answers on the SF-36 questionnaire.||Scores on SF-36 questionnaires||95% Confidence Interval|Mean
635222|NCT02643615|Secondary|Safety of Using SightSaver Visual Stimulator During Spine Prone Surgeries Under Balanced General Anesthesia Versus TIVA|Number of participants experiencing adverse events related to the study procedures during prone surgery and 24 hours after surgery under balanced general anesthesia versus TIVA|From start of surgery up to 24 hours after surgery|||Participants|||Count of Participants
635223|NCT02643615|Secondary|The Difference in VEP Changes in Amplitude Among Both Groups|The difference in VEP changes in amplitude with a single and double stimuli using the SightSaver visual stimulator under balanced general anesthesia versus TIVA.|every 30 minutes during the entire procedure for up to 6 hours|||milliseconds (ms)||95% Confidence Interval|Mean
635224|NCT02643615|Secondary|The Difference in VEP Changes in Amplitude Among Both Groups|VEP waveforms were evaluated using either present baseline - reproducible positive-negative-positive complex of substantial amplitude (≥2 µV) that appeared 100-200 ms after pulse stimulus onset; marginal Baseline – low amplitude (<2 µV) reproducible P100 waveform; or absent baseline – no repeatable response present. Any activity of <0.5 µV was not considered a response. Best derivation for each particular patient was used for monitoring electroretinogram (ERG) recording and confirming the stimulation.|Every 30 minutes during surgery for up to 6 hours|||micorvolts (µV)||95% Confidence Interval|Median
635225|NCT02643615|Primary|Efficacy in Detecting Subtle Intraoperative VEP Changes Using SightSaver Visual Stimulator During Spine Prone Surgeries Under Balanced General Anesthesia Versus TIVA.|Number of Participants with Subtle Intraoperative VEP Changes Observed Using SightSaver Visual Stimulator During Spine Prone Surgeries Under Balanced General Anesthesia Versus TIVA|VEP waveforms recorded every 30 minutes during the entire procedure for up to 6 hours.|||Participants|||Count of Participants
635226|NCT02643225|Primary|The Number of Participants Who Were Diagnosed With Fetal Macrosomia (Birth Weight)|The neonates will be weighed and fetal macrosomia will be diagnosed if fetal weight is 4 kg or more.|at birth|The patients will be divided into two groups, 40 pregnant women as case group with gestational diabetes mellitus and 40 non diabetic pregnant women as control group after being approved by the local hospital ethics and research committee.||participants|||Number
635227|NCT02643225|Secondary|Interventricular Septum Thickness|The interventricular septum thickness will be measured by ultrasound examination|36-37 weeks of gestation|The patients will be divided into two groups, 40 pregnant women as case group with gestational diabetes mellitus and 40 non diabetic pregnant women as control group after being approved by the local hospital ethics and research committee.||mm||Standard Deviation|Mean
635228|NCT02643225|Secondary|Prediction of Fetal Macrosomia by Measuring HbA1C in Participants|Venous blood samples will be taken from participants in clinical pathology department Ain Shams University, to measure the level of HbA1c using immunoassay technique.|36-37 weeks of gestation|The patients will be divided into two groups, 40 pregnant women as case group with gestational diabetes mellitus and 40 non diabetic pregnant women as control group after being approved by the local hospital ethics and research committee||percentage of glycosolated hemoglobin||Standard Deviation|Mean
635229|NCT02643225|Secondary|Umbilical Cordcross-sectional Area|the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device.|36-37 weeks of gestation|The patients will be divided into two groups, 40 pregnant women as case group with gestational diabetes mellitus and 40 non diabetic pregnant women as control group after being approved by the local hospital ethics and research committee||cm^2||Standard Deviation|Mean
635230|NCT02643199|Secondary|Number of Satisfactory Fetal Echocardiography Views by Five-Dimensional Ultrasound|"Fetal Echocardiography by Five-Dimensional Ultrasound measurement was done to examine fetal heart in both sagittal Views and transverse views:
Four chamber view
Five chamber view
Left outflow tract
Right outflow tract
3 vessels and Trachea View
Abdomen/Stomach
Ductal arch
aortic arch
Bicaval view then we count howmuch views of nine views were satisfactory"|20 - 36 weeks of gestation|||Number of satisfactory views||Standard Deviation|Mean
635231|NCT02643199|Primary|Number of Satisfactory Fetal Echocardiography Views by Two-Dimensional Ultrasound|"Fetal Echocardiography by Two-Dimensional Ultrasound measurement was done to examine fetal heart in both sagittal Views and transverse views:
Four chamber view
Five chamber view
Left outflow tract
Right outflow tract
3 vessels and Trachea View
Abdomen/Stomach
Ductal arch
aortic arch
Bicaval view then we count howmuch views of nine views were satisfactory"|20 - 36 weeks of gestation|||Number of satisfactory views||Standard Deviation|Mean
639817|NCT02371759|Primary|Systolic Blood Pressure at 35 Minutes|Systolic blood pressure values 30 minutes after local anesthesia injection|35th minute|||milimeters of Hg||Standard Deviation|Mean
635234|NCT02643004|Secondary|Lens Surface - Debris|Lens debris for senofilcon A and stenfilcon A is assessed at 1 week. Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe|1 week|A protocol deviation occurred for 2 participants and therefore resulted in incomplete data sets.||percentage of subjects|||Number
635235|NCT02643004|Secondary|Lens Surface - Debris|Lens debris for senofilcon A and stenfilcon A is assessed at baseline. Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe|Baseline|||percentage of subjects|||Number
635236|NCT02643004|Secondary|Lens Surface - Deposition|Lens surface for senofilcon A and stenfilcon A is assessed at 1 week. Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe|1 week|A protocol deviation occurred for 2 participants and therefore resulted in incomplete data sets.||percentage of subjects|||Number
635237|NCT02643004|Secondary|Lens Surface - Deposition|Lens surface for senofilcon A and stenfilcon A is assessed at baseline. Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe|Baseline|||percentage of subjects|||Number
635238|NCT02643004|Secondary|Visual Acuity|Measurement of visual acuity (VA) for senofilcon A and stenfilcon A assessed at baseline and 1 week using logMAR VA chart.|Baseline and 1 week|Protocol deviations occurred and therefore resulted in incomplete data sets.||LogMAR||Standard Deviation|Mean
635239|NCT02643004|Secondary|Lens Movement|Lens movement assessed for stenfilcon A and senofilcon A at 1 week using the following evaluations: extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive.|1 Week|A protocol deviation occurred for 2 participants and therefore resulted in incomplete data sets.||percentage of subjects|||Number
635240|NCT02643004|Secondary|Lens Movement|Lens movement assessed for stenfilcon A and senofilcon A at baseline using the following evaluations: extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive.|Baseline|||percentage of subjects|||Number
635241|NCT02643004|Secondary|Vertical Centration|Lens fit, vertical centration, will be assessed for senofilcon A and stenfilcon A at 1 week for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal|1 Week|A protocol deviation occurred for 2 participants and therefore resulted in incomplete data sets.||percentage of subjects|||Number
635242|NCT02643004|Secondary|Vertical Centration|Lens fit, vertical centration, will be assessed for senofilcon A and stenfilcon A at baseline for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal|Baseline|||percentage of subjects|||Number
635243|NCT02643004|Secondary|Horizontal Centration|Lens fit, horizontal centration, will be assessed for senofilcon A and stenfilcon A at 1 week for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal|1 Week|A protocol deviation occurred for 2 participants and therefore resulted in incomplete data sets.||percentage of subjects|||Number
635244|NCT02643004|Secondary|Horizontal Centration|Lens fit, horizontal centration will be assessed for senofilcon A and stenfilcon A at baseline for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal|Baseline|||percentage of subjects|||Number
635245|NCT02643004|Primary|Vision|Subjective responses for vision will be evaluated for each pair using questionnaire. Scale 0-100, 0=unacceptable, lens cannot be worn, 100=excellent.|Baseline and 1 week|A protocol deviation occurred for 1 participant and therefore resulted in incomplete data sets.||units on a scale||Standard Deviation|Mean
635246|NCT02643004|Primary|Dryness|Subjective responses for dryness will be evaluated for each pair using questionnaire. Scale 0-100, 0=extremely poor, high levels of dryness, 100=excellent, no dryness.|1 week|A protocol deviation occurred for 1 participant and therefore resulted in incomplete data sets.||units on a scale||Standard Deviation|Mean
635247|NCT02643004|Primary|Comfort|Subjective responses for comfort will be evaluated for each pair using questionnaire. Scale 0-100, 0=causes pain, cannot be tolerated, 100=excellent, cannot be felt.|Baseline and 1 week|A protocol deviation occurred for 1 participant and therefore resulted in incomplete data sets.||units on a scale||Standard Deviation|Mean
635248|NCT02643004|Primary|Overall Subjective Score of Lenses|Subjective responses will be evaluated for each pair using questionnaire. Scale 0-100, 0=extremely poor, 100=excellent.|Baseline and 1 week|A protocol deviation occurred for 1 participant and therefore resulted in incomplete data sets.||units on a scale||Standard Deviation|Mean
635249|NCT02643004|Primary|Ocular Physiology|Ocular physiology assessment of senofilcon A and stenfilcon A lenses by biomicroscopy for the following: corneal staining, conjunctival hyperaemia, limbal hyperaemia, and conjunctival staining. Scale 0-4, 0.25 steps, 0=normal, 4=severe.|Baseline and 1 week|Protocol deviations occurred for 2 participants and therefore resulted in incomplete data sets.||units on a scale||Standard Deviation|Mean
635250|NCT02642575|Secondary|The Volume-based Diameter (dV) of the Follicle by Five-Dimensional Ultrasound|"All women would be receiving ovarian stimulation using clomiphene citrate (clomid 50 mg) once daily for 5 days starting from 2nd day of the cycle then they will be scanned at 10th day by the same physician using Five Dimensional Ultrasound was done.
Five Dimensional Ultrasound automatically identifies hypoechogenic follicles within the captured ovarian volume and generates a set of measurements for each follicle including the volume-based diameter (dV) of the follicle.
The volume calculation is based on the voxel count within the identified follicle. It therefore represents a true measure of follicular volume."|10th day of the menstrual cycle|67 women were recruited from the Fetal Care Unit who fulfilled the inclusion criteria. Verbal consent was obtained from participants who were included into the study.||mm^3||Standard Deviation|Mean
635251|NCT02642575|Secondary|The Mean Follicular Diameter by Five-Dimensional Ultrasound|"All women would be receiving ovarian stimulation using clomiphene citrate (clomid 50 mg) once daily for 5 days starting from 2nd day of the cycle then they will be scanned at 10th day by the same physician using Five Dimensional Ultrasound was done.
Five Dimensional Ultrasound automatically identifies hypoechogenic follicles within the captured ovarian volume and generates a set of measurements for each follicle. These measurements include the largest diameters in three orthogonal planes, the mean follicular diameter (MFD)"|10th day of the menstrual cycle|67 women were recruited from the Fetal Care Unit who fulfilled the inclusion criteria. Verbal consent was obtained from participants who were included into the study.||mm||Standard Deviation|Mean
635365|NCT02634788|Secondary|Total Use of Rescue Medication Over 0 to 24 Hours and 0 to 48 Hours|Total use of rescue medication is defined as the number of times a participant took rescue medication.|Over 24 and 48 hours after Time 0 (first dose of study drug)|All randomized participants from the ITT Population who used rescue medication during the specified time intervals.||number of uses||Standard Deviation|Mean
635252|NCT02642575|Primary|The Mean Follicular Diameter by Two-Dimensional Ultrasound|"All women would be receiving ovarian stimulation using clomiphene citrate (clomid 50 mg) once daily for 5 days starting from 2nd day of the cycle then they will be scanned at 10th day by the same physician using Two Dimensional Ultrasound was done.
Each follicle was assessed by measuring the maximal diameters on three orthogonal planes.
The mean of three diameters was calculated."|10th day of the menstrual cycle|67 women were recruited from the Fetal Care Unit who fulfilled the inclusion criteria. Verbal consent was obtained from participants who were included into the study.||mm||Standard Deviation|Mean
635253|NCT02642536|Secondary|Assessing PTSD Symptom Severity|PTSD symptom severity will be measured by the PCL-M at baseline and post treatment (16 weeks) minimum-maximum total score range (17-85) Higher value represents greater PTSD symptom severity An overall score was obtained from 4 subscales.|baseline|||units on a scale||Standard Deviation|Mean
635254|NCT02642536|Secondary|Assessing Anxiety Symptom Severity|Anxiety symptom severity will be measured by the GAD-7 at baseline and post treatment (16 weeks) minimum-maximum total score range (0-21) Higher value represents greater anxiety symptom severity An overall score was obtained from the 7-item measure.|baseline|||units on a scale||Standard Deviation|Mean
635255|NCT02642536|Secondary|Assessing Depression Symptom Severity|Changes in depression symptom severity will be measured at baseline and post treatment (16 weeks) minimum-maximum total score range (0-24) Higher value represents greater depressive symptom severity An overall score was obtained from the 8-item measure.|baseline|||units on a scale||Standard Deviation|Mean
635256|NCT02642536|Secondary|Assessing PTSD Symptom Severity|PTSD symptom severity will be measured by the PCL-M at baseline and post treatment (16 weeks) minimum-maximum total score range (17-85) Higher value represents greater PTSD symptom severity An overall score was obtained from 4 subscales.|16 weeks|||units on a scale||Standard Deviation|Mean
635257|NCT02642536|Secondary|Assessing Anxiety Symptom Severity|Anxiety symptom severity will be measured by the GAD-7 at baseline and post treatment (16 weeks) minimum-maximum total score range (0-21) Higher value represents greater anxiety symptom severity An overall score was obtained from the 7-item measure.|16 weeks|||units on a scale||Standard Deviation|Mean
635258|NCT02642536|Secondary|Assessing Depression Symptom Severity|Changes in depression symptom severity will be measured at baseline and post treatment (16 weeks) minimum-maximum total score range (0-24) Higher value represents greater depressive symptom severity An overall score was obtained from the 8-item measure.|16 weeks|frequency analysis||units on a scale||Standard Deviation|Mean
635259|NCT02642536|Primary|Self Efficacy for Practicing Good Dietary Habits|Self-efficacy for practicing healthy dietary habits during difficult times will be assessed at baseline and post treatment (16 weeks) minimum-maximum total score range (20-100) Higher value represents greater sense of self-efficacy for healthy eating during difficult times The score was obtained from 3 subscales|16 weeks|||units on a scale||Standard Deviation|Mean
635260|NCT02642536|Primary|Self Efficacy for Practicing Good Dietary Habits|Self-efficacy for practicing healthy dietary habits during difficult times will be assessed at baseline and post treatment (16 weeks) minimum-maximum total score range (20-100) Higher value represents greater sense of self-efficacy for healthy eating during difficult times The score was obtained from 3 subscales|baseline|||units on a scale||Standard Deviation|Mean
635261|NCT02642536|Primary|Number of Days Engaged in Vigorous Activity|Initial assessment of vigor and time spent on physical activity minimum-maximum total score range (0-32) Higher value represents more days spent performing vigorous physical activity The score was obtained from a single item|baseline|||days spent performing vigorous activity||Standard Deviation|Mean
635262|NCT02642536|Primary|Number of Days Engaged in Vigorous Activity|changes in vigor and time spent on physical activity practice will be measured by the MOVE! 11 assessment at post treatment (16 weeks) minimum-maximum total score range (0-48) Higher value represents more days spent performing vigorous activity|16 weeks|||days spent performing vigorous activity||Standard Deviation|Mean
635263|NCT02642536|Primary|MOVE! Attendance|Number of MOVE! sessions attended minimum-maximum total score range (2-12) Higher value represents more sessions attended The score was obtained from a single item|16 weeks|||number of sessions||Standard Deviation|Mean
635267|NCT02641912|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were events on administration of investigational product from screening (Day 1) to 5 days after last administration of the product on Day 8. Number of participants with TEAEs were reported.|up to 13 days|Analysis for this outcome was conducted on safety population which included all participants who were randomized and received at least one dose of study treatment during the study.||Number of participants|||Number
639818|NCT02371759|Primary|Systolic Blood Pressure at 20 Minutes|Systolic blood pressure values 15 minutes after local anesthesia injection|20th minute|||milimeters of Hg||Standard Deviation|Mean
635268|NCT02641912|Secondary|Mean Response to Post-Product Use Sensory Questionnaire (PPUSQ) on Day 1, Day 3, Day 8|Participants answered 4 questions on PPUSQ as follows: Q1:Which of the following statements best describes how much you liked the product overall?(rated on scale of 1-6, 1=Did not like it at all; 2=Did not like it that much; 3=Like it slightly; 4=Like it somewhat; 5=Like it very much; 6=Like it extremely), Q2:How pleasant would you say the flavor of the product was?(rated on scale of 1-5, 1=Not pleasant at all; 2=Slightly pleasant; 3=Moderately pleasant; 4=Very pleasant; 5=Extremely pleasant), Q3:How gentle would you say the product was?(rated on a scale of 1-7, 1=Not gentle at all; 2=Barely gentle; 3=Slightly gentle; 4=Moderately gentle; 5=Very gentle; 6=Extremely gentle; 7=The most gentle product imaginable), Q4:How fresh would you say your mouth felt after using the product?(rated on a scale of 1-5; 1=Not at all fresh; 2=Not very fresh; 3=Somewhat fresh; 4=Very fresh; 5=Extremely fresh) & response to these questions was reported. Scale score was averaged to calculate the response|Day 1, Day 3, Day 8|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy.||score on a scale||Standard Error|Least Squares Mean
635269|NCT02641912|Secondary|Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8|Number Participants were reported who answered following questions with respect to how much they agree or disagree with following statements over the last week & how much they agreed that symptoms were manageable (M). Q40:It’s a big issue for me; Q41:My dry mouth makes me feel different to other people; Q42:My mouth is deteriorating, Dry mouth can also affect your quality of life. Q43:Dry mouth is part of my life nowadays; Q44:Dry mouth is a quality of life issue; Q45:My dry mouth stops me enjoying things; Q46:How would you rate your oral health overall?, and Think back over last week about things you have done to relieve your symptoms. How much do you agree or disagree that those things have made following symptoms more manageable? M1:Uncomfortable; M2:Bad taste; M3:Loss of Taste; M4:Lips sticking to roof of mouth; M5:Tongue sticking to roof of mouth; M6: Throat dry; M7:No moisture; M8:Devoid of any wetness M9:Mouth feels tight ?|Prior to treatment on Day 8|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy.||Number of participants|||Number
635270|NCT02641912|Secondary|Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8|Number of participants were reported who answered following questions, these questions are about how you have coped with your dry mouth over last week. Please tell us whether you agree or disagree with each of the statements. Q28:I have to drink a lot of water; Q29:I need to carry water with me everywhere I go; Q30:I worry about where I can go to toilet; Q31:I have to drink something with food; Q32:I have to clean my teeth more than most people; Q33:I choose moist foods when I can; Q34:I need sauces to help me eat; Q35:I avoid certain foods or drinks, There are other things that help some people with dry mouth. Please tell us how often over last week, that you have done these things. Q36:I have chewed gum; Q37:I have chewed my food for longer; Q38:I have sucked sweets or mints or pastilles; Q39:I have breathed through my nose rather than my mouth.|Prior to treatment on Day 8|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy.||Number of participants|||Number
635271|NCT02641912|Secondary|Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8|Number of participants were reported who answered following questions, how often during last week has a dry mouth affected these aspects of your life? Q16:My dry mouth interrupts my sleep; Q17:My dry mouth makes it difficult for me to speak; Q18:My dry mouth interferes with me being intimate with those close to me; Q19:My dry mouth means it takes me longer to eat meals, Having a dry mouth can affect people’s moods and emotions. Please tell us how much you agree or disagree that your dry mouth has given you these moods over the last week Q20:Irritable; Q21:Worried; Q22:Frustrated; Q23:Always on my mind; Q24:It gets me down, and How much do you agree or disagree that your dry mouth has affected your time with other people over last week? Q25:Drinking or going to the toilet interrupts my conversations; Q26:I have difficulty using the telephone Q27:I feel different because of the things I have to do to look after my mouth.|Prior to treatment on Day 8|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy.||Number of participants|||Number
635272|NCT02641912|Secondary|Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8|Number of participants were reported who answered following questions, Q1:Thinking back during last week, how often has your dry mouth been a problem?; Having a dry mouth affects people in different ways. Please tell us how much you agree or disagree whether your dry mouth has affected you in these ways in last week Q2:Rawness or soreness? Q3:Uncomfortable? Q4:Bad taste? Q5:Loss of taste? Q6:Lips sticking to teeth? Q7:Tongue sticking to roof of mouth? Q8:Throat dry? Q9:No moisture? Q10:Mouth feels tight? Dry mouth stops some people doing things. How much do you agree or disagree that it has been difficult for you to do following things in last week? Q11:Eating dry foods? Q12:Eating sticky foods? Q13:Eating hard or scratchy foods such as crisps, biscuits or nuts?, and How much do you recognize yourself in following statements, based on last week? Q14:Swallowing has been difficult for me this last week? Q15:Drinking so much means that I go to the toilet more than other people?|Prior to treatment on Day 8|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy.||Number of participants|||Number
635279|NCT02641912|Secondary|Mean Response to PPAQ4 Prior to Treatment on Day 3|Participants answered to the 9 questions in PPAQ4. Q1= Providing relief all night; Q2= Reducing the number of times you wake up from dry mouth; Q3= Feeling less parched when you wake up; Q4= Having a long lasting dry mouth relief; Q5= Having a long lasting lubricating effect; Q6= Having a long lasting moisturizing effect; Q7= Having an overall dry mouth relief; Q8= Having an overall lubrication effect; Q9= Having an overall moisturizing effect. These questions were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|Prior to treatment on Day 3|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.||score on a scale||Standard Deviation|Mean
635273|NCT02641912|Secondary|Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1|Number Participants were reported who answered following questions with respect to how much they agree or disagree with following statements over the last week & how much they agreed that symptoms were manageable (M). Q40:It’s a big issue for me; Q41:My dry mouth makes me feel different to other people; Q42:My mouth is deteriorating, Dry mouth can also affect your quality of life; Q43:Dry mouth is part of my life nowadays; Q44:Dry mouth is a quality of life issue; Q45:My dry mouth stops me enjoying things; Q46:How would you rate your oral health overall?, and Think back over last week about things you have done to relieve your symptoms. How much do you agree or disagree that those things have made following symptoms more manageable? M1: Uncomfortable; M2: Bad taste; M3:Loss of Taste; M4: Lips sticking to roof of mouth; M5: Tongue sticking to roof of mouth; M6: Throat dry; M7: No moisture M8:Devoid of any wetness M9:Mouth feels tight ?|Prior to treatment on Day 1|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy.||Number of participants|||Number
635274|NCT02641912|Secondary|Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1|Number of participants were reported who answered following questions, these questions were about how participants had coped with their dry mouth over the last week with respect to agree or disagree with each of the following questions. Q28:I have to drink a lot of water; Q29:I need to carry water with me everywhere I go; Q30:I worry about where I can go to the toilet; Q31:I have to drink something with food; Q32:I have to clean my teeth more than most people; Q33:I choose moist foods when I can; Q34:I need sauces to help me eat; Q35:I avoid certain foods or drinks, and There are other things that help some people with dry mouth. Please tell us how often over the last week, that you have done these things. Q36:I have chewed gum; Q37:I have chewed my food for longer; Q38:I have sucked sweets or mints or pastilles; Q39:I have breathed through my nose rather than my mouth.|Prior to treatment on Day 1|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy.||Number of participants|||Number
635275|NCT02641912|Secondary|Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1|Number of Participants were reported who answered following questions, how often during last week has a dry mouth affected these aspects of your life? Q16:My dry mouth interrupts my sleep; Q17:My dry mouth makes it difficult for me to speak; Q18:My dry mouth interferes with me being intimate with those close to me; Q19:My dry mouth means it takes me longer to eat meals, Having a dry mouth can affect people’s moods & emotions. Please tell us how much you agree or disagree that your dry mouth has given you these moods over last week; Q20:Irritable; Q21:Worried; Q22:Frustrated; Q23:Always on my mind; Q24:It gets me down, How much do you agree or disagree that your dry mouth has affected your time with other people over the last week?; Q25:Drinking or going to the toilet interrupts my conversations; Q26:I have difficulty using the telephone; Q27:I feel different because of the things I have to do to look after my mouth.|Prior to treatment on Day 1|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy.||Number of participants|||Number
635276|NCT02641912|Secondary|Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1|Number of Participants were reported who answered following questions, Q1:Thinking back during last week, how often has your dry mouth been a problem? Having a dry mouth affects people in different ways. Please tell us how much you agree or disagree whether your dry mouth has affected you in these ways in last week Q2:Rawness or soreness? Q3:Uncomfortable? Q4:Bad taste? Q5:Loss of taste? Q6:Lips sticking to teeth? Q7:Tongue sticking to roof of mouth? Q8:Throat dry? Q9:No moisture? Q10:Mouth feels tight? Dry mouth stops some people doing things. How much do you agree or disagree that it has been difficult for you to do following things in last week? Q11:Eating dry foods? Q12:Eating sticky foods? Q13:Eating hard or scratchy foods such as crisps, biscuits or nuts?, How much do you recognize yourself in following statements, based on the last week? Q14:Swallowing has been difficult for me this last week? Q15:Drinking so much means that I go to the toilet more than other people?|Prior to treatment on Day 1|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy.||Number of participants|||Number
635277|NCT02641912|Secondary|Mean Response to SAoP QoL 2 Prior to Treatment on Day 8|Participants answered to the 6 questions in SAoP QoL 2 as follows: Q1= Looking back over the last 7 days, has your dry mouth caused discomfort?; Q2= Looking back over the last 7 days, has your dry mouth made it uncomfortable to speak?; Q3= Looking back over the last 7 days, has your dry mouth interrupted your sleep?; Q4= Looking back over the last 7 days, has your dry mouth affected your social interactions?; Q5= Looking back over the last 7 days, has your dry mouth caused you to avoid certain foods?; Q6= Looking back over the last 7 days, has your dry mouth interfered with your daily activities? These questions were rated on scale as follows: 0 = not at all; 1 = a little; 2 = somewhat; 3 = quite a bit; 4 = very much. Scale score was averaged to calculate the response.|prior to treatment on Day 8|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy.||score on a scale||Standard Deviation|Mean
635278|NCT02641912|Secondary|Mean Response to Subjective Assessment of Patient’s Quality of Life (SAoP QoL1) Prior to Treatment on Day 1|Participants answered to the 6 questions in SAoP QoL as follows: Q1= Does your dry mouth cause discomfort?; Q2= Does your dry mouth make it uncomfortable to speak?; Q3= Does your dry mouth interrupt your sleep?; Q4= Does your dry mouth affect your social interactions?; Q5= Does your dry mouth cause you to avoid certain foods?; Q6= Does your dry mouth interfere with your daily activities? These questions were rated on a scale as follows: 0 = not at all; 1 = a little; 2 = somewhat; 3 = quite a bit; 4 = very much. Scale score was averaged to calculate the response.|Prior to treatment on Day 1|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy.||score on a scale||Standard Deviation|Mean
636588|NCT02540850|Secondary|Specificity (Specificity of mSEPT9 Assay in Non-CRC Diseases and NED (no Evidence of Diseases))|the ratio of negative cases in all non-CRC or NED cases|1 year|||percentage of true negs in non-CRC group|||Number
635280|NCT02641912|Secondary|Mean Response to PPAQ3 at 240 Mins Post Treatment on Day 3|Participants answered to the 14 questions in PPAQ3. Q1= Relieving the discomfort of dry mouth; Q2= Feeling comfortable in the mouth; Q3= Soothing your mouth; Q4= Allowing you to speak without difficulty; Q5= Effectively moistens your mouth; Q6= Effectively lubricates your mouth; Q7= Helping to freshen your breath; Q8= Protecting your mouth from drying out; Q9= Providing whole mouth comfort; Q10= Helping you to swallow without difficulty; Q11= Helping mouth feel normal; Q12= Having a long lasting dry mouth relief; Q13= Having a long lasting lubricating effect; Q14= Having a long lasting moisturizing effect. These questions were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|240 mins post treatment on Day 3|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.||score on a scale||Standard Deviation|Mean
635281|NCT02641912|Secondary|Mean Response to PPAQ3 at 120 Mins Post Treatment on Day 3|Participants answered to the 14 questions in PPAQ3 as follows: Q1= Relieving the discomfort of dry mouth; Q2= Feeling comfortable in the mouth; Q3= Soothing your mouth; Q4= Allowing you to speak without difficulty; Q5= Effectively moistens your mouth; Q6= Effectively lubricates your mouth; Q7= Helping to freshen your breath; Q8= Protecting your mouth from drying out; Q9= Providing whole mouth comfort; Q10= Helping you to swallow without difficulty; Q11= Helping mouth feel normal; Q12= Having a long lasting dry mouth relief; Q13= Having a long lasting lubricating effect; Q14= Having a long lasting moisturizing effect. These questions were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|120 mins post treatment on Day 3|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.||score on a scale||Standard Deviation|Mean
635282|NCT02641912|Secondary|Mean Response to PPAQ3 at 60 Mins Post Treatment on Day 3|Participants answered the 14 questions of PPAQ3 as follows: Q1= Relieving the discomfort of dry mouth; Q2= Feeling comfortable in the mouth; Q3= Soothing your mouth; Q4= Allowing you to speak without difficulty; Q5= Effectively moistens your mouth; Q6= Effectively lubricates your mouth; Q7= Helping to freshen your breath; Q8= Protecting your mouth from drying out; Q9= Providing whole mouth comfort; Q10= Helping you to swallow without difficulty; Q11= Helping mouth feel normal; Q12= Having a long lasting dry mouth relief; Q13= Having a long lasting lubricating effect; Q14= Having a long lasting moisturizing effect. These questions were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|60 mins. post treatment on Day 3|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.||score on a scale||Standard Deviation|Mean
635283|NCT02641912|Secondary|Mean Response to PPAQ2 at 30 Mins Post Treatment on Day 3|Participants answered to the 11 questions in PPAQ2 as follows: Q1= Relieving the discomfort of dry mouth; Q2= Feeling comfortable in the mouth; Q3= Soothing your mouth; Q4= Allowing you to speak without difficulty; Q5= Effectively moistens your mouth; Q6= Effectively lubricates your mouth; Q7= Helping to freshen your breath; Q8= Protecting your mouth from drying out; Q9= Providing whole mouth comfort; Q10= Helping you to swallow without difficulty; Q11= Helping mouth feel normal. These questions were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|30 mins post treatment on Day 3|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.||score on a scale||Standard Deviation|Mean
635284|NCT02641912|Secondary|Mean Response to PPAQ1 at 5 Mins Post Treatment on Day 3|Participants answered to the 3 questions in PPAQ1 as follows: Q1= Having a immediate dry mouth relief; Q2= Having a immediate lubricating effect; Q3= Having a immediate moisturizing effect. These questions were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|5 mins post treatment on Day 3|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.||score on a scale||Standard Deviation|Mean
635285|NCT02641912|Secondary|Mean Response to PPAQ3 at 240 Mins Post Treatment on Day 1|Participants answered to the 14 questions in PPAQ3 as follows: Q1= Relieving the discomfort of dry mouth; Q2= Feeling comfortable in the mouth; Q3= Soothing your mouth; Q4= Allowing you to speak without difficulty; Q5= Effectively moistens your mouth; Q6= Effectively lubricates your mouth; Q7= Helping to freshen your breath; Q8= Protecting your mouth from drying out; Q9= Providing whole mouth comfort; Q10= Helping you to swallow without difficulty; Q11= Helping mouth feel normal; Q12= Having a long lasting dry mouth relief; Q13= Having a long lasting lubricating effect; Q14= Having a long lasting moisturizing effect. These questions were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|240 mins post treatment on Day 1|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.||score on a scale||Standard Deviation|Mean
635366|NCT02634788|Secondary|Time to First Use of Rescue Medication for Pain|Time to first use of rescue medication is the time from Time 0 (time of administration of the first dose of study drug) to the first use of rescue medication. If rescue medication was not taken the time was censored at the time of the last pain assessment.|From Time 0 to time of first use of rescue medication (up to 280 minutes)|All randomized participants from the ITT Population.||minutes||95% Confidence Interval|Median
639963|NCT02368314|Secondary|Frequency of Death From Other Causes||During the treatment period (14 days) and follow-up period (till 60-th day)||||||
635286|NCT02641912|Secondary|Mean Response to PPAQ3 at 120 Mins Post Treatment on Day 1|Participants answered to the 14 questions in PPAQ3. Q1= Relieving the discomfort of dry mouth; Q2= Feeling comfortable in the mouth; Q3= Soothing your mouth; Q4= Allowing you to speak without difficulty; Q5= Effectively moistens your mouth; Q6= Effectively lubricates your mouth; Q7= Helping to freshen your breath; Q8= Protecting your mouth from drying out; Q9= Providing whole mouth comfort; Q10= Helping you to swallow without difficulty; Q11= Helping mouth feel normal; Q12= Having a long lasting dry mouth relief; Q13= Having a long lasting lubricating effect; Q14= Having a long lasting moisturizing effect. These questions were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|120 mins post treatment on Day 1|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.||score on a scale||Standard Deviation|Mean
635287|NCT02641912|Secondary|Mean Response to PPAQ3 at 60 Mins Post Treatment on Day 1|Participants answered to the 14 questions in PPAQ3. Q1= Relieving the discomfort of dry mouth; Q2= Feeling comfortable in the mouth; Q3= Soothing your mouth; Q4= Allowing you to speak without difficulty; Q5= Effectively moistens your mouth; Q6= Effectively lubricates your mouth; Q7= Helping to freshen your breath; Q8= Protecting your mouth from drying out; Q9= Providing whole mouth comfort; Q10= Helping you to swallow without difficulty; Q11= Helping mouth feel normal; Q12= Having a long lasting dry mouth relief; Q13= Having a long lasting lubricating effect; Q14= Having a long lasting moisturizing effect. These questions were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|60 mins post treatment on Day 1|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.||score on a scale||Standard Deviation|Mean
635288|NCT02641912|Secondary|Mean Response to PPAQ2 at 30 Mins Post Treatment on Day 1|Participants answered to the 11 question in PPAQ2. Q1= Relieving the discomfort of dry mouth; Q2= Feeling comfortable in the mouth; Q3= Soothing your mouth; Q4= Allowing you to speak without difficulty; Q5= Effectively moistens your mouth; Q6= Effectively lubricates your mouth; Q7= Helping to freshen your breath; Q8= Protecting your mouth from drying out; Q9= Providing whole mouth comfort; Q10= Helping you to swallow without difficulty; Q11= Helping mouth feel normal. These questions were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|30 mins post treatment on Day 1|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.||score on a scale||Standard Deviation|Mean
635289|NCT02641912|Secondary|Mean Response to PPAQ1 at 5 Mins Post Treatment on Day 1|Participants answered to the 3 question in PPAQ1. Q1= Having a immediate dry mouth relief; Q2= Having a immediate lubricating effect; Q3= Having a immediate moisturizing effect. These questions were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|5 mins post treatment on Day 1|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.||score on a scale||Standard Deviation|Mean
635290|NCT02641912|Secondary|Mean Response to Product Performance And Attributes Questionnaire 4(PPAQ4) Prior to Treatment on Day 8|Participants answered the 9 questions of PPAQ4. Q1= Providing relief all night; Q2= Reducing the number of times you wake up from dry mouth; Q3= Feeling less parched when you wake up; Q4= Having a long lasting dry mouth relief; Q5= Having a long lasting lubricating effect; Q6= Having a long lasting moisturizing effect; Q7= Having an overall dry mouth relief; Q8= Having an overall lubrication effect; Q9= Having an overall moisturizing effect. These question were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|prior to treatment on Day 8|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.||score on a scale||Standard Deviation|Mean
635291|NCT02641912|Secondary|Mean Response to Questions (Q) Number 2 to 14 (Q2 to Q14) From PPAQ3 at 240 Mins. Post Treatment on Day 8|Participants answered Q2- Q14 from PPAQ3. Q2= Feeling comfortable in the mouth; Q3= Soothing your mouth; Q4= Allowing you to speak without difficulty; Q5= Effectively moistens your mouth; Q6= Effectively lubricates your mouth; Q7= Helping to freshen your breath; Q8= Protecting your mouth from drying out; Q9= Providing whole mouth comfort; Q10= Helping you to swallow without difficulty; Q11= Helping mouth feel normal; Q12= Having a long lasting dry mouth relief; Q13= Having a long lasting lubricating effect; Q14= Having a long lasting moisturizing effect. These question were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|240 mins. post treatment on Day 8|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.||score on a scale||Standard Deviation|Mean
635307|NCT02641379|Secondary|Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 1)|Liver fibrosis stage was scored using the METAVIR system (Grade 0 to 4). Grade 0 indicates no fibrosis, Grade 1 indicates stellate enlargement of portal tract but without septa formation, Grade 2 indicates enlargement of portal tract with rare septa formation, Grade 3 indicates numerous septa without cirrhosis and grade 4 indicates cirrhosis. The number of participants with fibrosis grades ranging from 0 to 4 at Baseline is presented.|Baseline (Day 1)|The safety population included all participants who received at least on dose of (either) study drug and had at least one post-baseline safety assessment.||Number of participants|||Number
635292|NCT02641912|Secondary|Mean Response to Question (Q) Number 2 to 14 (Q2-Q14) From PPAQ3 at 120 Mins. Post Treatment on Day 8|Participants answered Q2- Q14 from PPAQ3. Q2= Feeling comfortable in the mouth; Q3= Soothing your mouth; Q4= Allowing you to speak without difficulty; Q5= Effectively moistens your mouth; Q6= Effectively lubricates your mouth; Q7= Helping to freshen your breath; Q8= Protecting your mouth from drying out; Q9= Providing whole mouth comfort; Q10= Helping you to swallow without difficulty; Q11= Helping mouth feel normal; Q12= Having a long lasting dry mouth relief; Q13= Having a long lasting lubricating effect; Q14= Having a long lasting moisturizing effect. These question were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|120 mins. post treatment on Day 8|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.||score on a scale||Standard Deviation|Mean
635293|NCT02641912|Secondary|Mean Response to Question (Q) Number 2 to 14 (Q2-Q14) From PPAQ3 at 60 Mins. Post Treatment on Day 8|Participants answered Q2- Q14 from PPAQ3. Q2= Feeling comfortable in the mouth; Q3= Soothing your mouth; Q4= Allowing you to speak without difficulty; Q5= Effectively moistens your mouth; Q6= Effectively lubricates your mouth; Q7= Helping to freshen your breath; Q8= Protecting your mouth from drying out; Q9= Providing whole mouth comfort; Q10= Helping you to swallow without difficulty; Q11= Helping mouth feel normal; Q12= Having a long lasting dry mouth relief; Q13= Having a long lasting lubricating effect; Q14= Having a long lasting moisturizing effect. These question were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|60 mins. post treatment on Day 8|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.||score on a scale||Standard Deviation|Mean
635294|NCT02641912|Secondary|Mean Response to Question(Q) Number 2 to 11 (Q2 to Q11) From PPAQ2 at 30 Mins Post Treatment on Day 8|Participants answered questions, Q2-Q11 in PPAQ2. Q2=Feeling comfortable in the mouth; Q3=Soothing your mouth; Q4= Allowing you to speak without difficulty; Q5= Effectively moistens your mouth; Q6= Effectively lubricates your mouth; Q7= Helping to freshen your breath; Q8= Protecting your mouth from drying out; Q=9 Providing whole mouth comfort; Q10= Helping you to swallow without difficulty; Q11= Helping mouth feel normal. These questions were rated on a scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|30 mins post treatment on Day 8|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.||score on a scale||Standard Deviation|Mean
635295|NCT02641912|Secondary|Mean Response to Product Performance And Attributes Questionnaire1(PPAQ1) at 5 Mins Post Treatment on Day 8|Participants answered 3 questions in PPAQ1. Q1= Having a immediate dry mouth relief; Q2= Having a immediate lubricating effect; Q3= Having a immediate moisturizing effect. These questions were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|5 mins post treatment on Day 8|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.||score on a scale||Standard Deviation|Mean
635296|NCT02641912|Secondary|Mean Response to the Question 1 ‘Relieving the Discomfort of Dry Mouth’ in PPAQ3 at 60 and 240 Mins Post Treatment on Day 8|Participants answered to the question 1 ‘Relieving the discomfort of dry mouth’ in PPAQ3 and rated this question on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|60 and 240 mins post treatment on Day 8|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.||score on a scale||Standard Deviation|Mean
635297|NCT02641912|Secondary|Mean Response to the Question 1 ‘Relieving the Discomfort of Dry Mouth’ in Product Performance And Attributes Questionnaire 2 (PPAQ2) at 30 Mins Post Treatment on Day 8|Participants answered to the question 1 ‘Relieving the discomfort of dry mouth’ in PPAQ2 and rated this question on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|30 mins post treatment on Day 8|ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. Number of participants analyzed for this outcome is the part of ITT population for specific question at specific time point.||score on a scale||Standard Deviation|Mean
635298|NCT02641912|Primary|Mean Response to the Question 1 ‘Relieving the Discomfort of Dry Mouth’ in Product Performance and Attributes Questionnaire 3 (PPAQ3) at 120 Minutes(Mins) Post Treatment on Day 8|Participants answered question 1 ‘Relieving the discomfort of dry mouth’ in PPAQ3 and rated this question on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|120 mins post treatment on Day 8|Intent-to-treat (ITT) population which included all participants who were randomized, received study treatment at least once & provided at least one post-baseline (post treatment) assessment of efficacy. Number of participants analyzed for this outcome is the part of ITT population for specific question at specific time point.||score on a scale||Standard Deviation|Mean
635339|NCT02638493|Primary|Semen Clearance (CL) of Tenofovir|Samples will be analyzed for drug concentrations at the following time points post dose: 3, 6, 9, 12, 18 and 24 hours, and used to estimate clearance from semen from a 300mg dose of tenofovir.|Samples collected at 3, 6, 9, 12, 18 and 24 hours post-dose|||L/hr||Inter-Quartile Range|Median
636589|NCT02540850|Secondary|Sensitivity (Sensitivity of mSEPT9 Assay in Detecting Colorectal Cancer)|the ratio of positive cases in all CRC cases|1 year|||Percentage of positives in disease group|||Number
635299|NCT02641379|Secondary|Number of Participants With Adverse Events and Serious Adverse Events (Part 2)|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.|Up to Week 96|The safety population included all participants who received at least on dose of (either) study drug and had at least one post-baseline safety assessment.||Number of participants|||Number
635300|NCT02641379|Secondary|Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 2)|Liver fibrosis stage was based upon biopsy and scored using the METAVIR system (Grade 0 to 4). Grade 0 indicates no fibrosis, Grade 1 indicates stellate enlargement of portal tract but without septa formation, Grade 2 indicates enlargement of portal tract with rare septa formation, Grade 3 indicates numerous septa without cirrhosis and grade 4 indicates cirrhosis. The number of participants with fibrosis grades ranging from 0 to 4 at Baseline (Day 1) is presented.|Baseline (Day 1)|The ITT population included all participants randomized and allocated to receive treatments.||Number of participants|||Number
635301|NCT02641379|Secondary|Mean Fatigue Severity Scale Scores for Groups A1, B1 and C Over Time (Part 2)|The FSS is an instrument consisting of 10 self-administered questions. The FSS items were scored by calculating the average response to all answered items (including the 9 questions and the fatigue symptoms). Each of the 9 questions had answers within a score range of 1-7. A score of 1 for any question indicates less fatigue in everyday life and a score of 7 indicates a higher likelihood of fatigue in everyday life. The mean FSS scores are presented at Baseline (Day 1), Week 24, Week 48 and Week 72 (for Groups A1, B1 and C) and at Week 96 (for Groups B1 and C).|Baseline (Day 1), Week 24, Week 48 and Week 72, and Week 96|The ITT population included all participants randomized and allocated to receive treatments. Here, 'n' = the number of participants analyzed for a given time point.||scores on a scale||Standard Deviation|Mean
635302|NCT02641379|Secondary|Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2)|The SF-36 is a quality of life instrument consisting of a 36-item questionnaire. The SF-36 items were scored and transformed according to the SF-36 Health Survey Manual & Interpretation Guide. Summary scores for SF-36 dimensions (physical functioning, role functioning, bodily pain, general health, vitality, social functioning, mental health, health transition) as well as physical and mental summary measures were compiled after imputation of mean scores for missing items if more than 50% of dimension-related items were available. Scores for health transition ranged from 0 (worst) to 5 (best). Scores for all other dimensions ranged from 0 (worst) to 100 (best). The mean SF-36 scores were presented at Baseline (Day 1), Week 24, Week 48, Week 72 (for Groups A1, B1 and C) and at Week 96 (for Groups B1 and C). Lower score indicate worsening.|Baseline (Day 1), Week 24, Week 48, Week 72, and Week 96|The ITT population included all participants randomized and allocated to receive treatments. Here, 'n' = the number of participants analyzed at a given time point.||scores on a scale||Standard Deviation|Mean
635303|NCT02641379|Secondary|Percentage of Participants Achieving Sustained Virological Response in Groups C and D by Genotype at the End of Follow-up (Part 2)|The SVR was defined as the percentage of participants in each group with non-detectable HCV RNA result at 24 weeks post completion of the treatment period (HCV RNA < 15 IU/ml at Week 48 of Group D and at Week 96 of Group C). Participants without a HCV RNA results at this time point were considered as non-responders. The end of follow-up was defined as Week 96 for Group C and Week 48 for Group D.|Up to Week 96|The ITT population included all participants randomized and allocated to receive treatments.||Percentage of participants||95% Confidence Interval|Number
635304|NCT02641379|Secondary|Percentage of Participants With Virological Response Rates in Group A1, B1, C and D at the End of the Treatment Period (Part 2)|ETR virological response rate at the end of treatment period was defined as the percentage of participants in each group with non-detectable HCV RNA at completion of the treatment period (HCV RNA quantitative PCR result < 15 IU/ml at Week 24 for Group D, at Week 48 for Group A1, at Week 72 for Groups B1 and C). Participants without a HCV RNA PCR (missing values) at this time point were considered as non-responders in this calculation. The end of treatment period was defined as Week 48 for Group A1, Week 72 for Groups B1 and C1, and Week 24 for Group D.|Up to Week 72|The ITT population included all participants randomized and allocated to receive treatments.||Percentage of participants||95% Confidence Interval|Number
635305|NCT02641379|Secondary|Percentage of Participants With Relapse Rates in Groups A1 and B1 at the End of Follow-up (Part 2)|Virological relapse rate was defined as percentage of participants with non-detectable HCV RNA (< 15 IU/ml) at the EoT and detectable HCV RNA (≥ 15 IU/ml) at the end of FU. The end of treatment was defined as Week 48 in Group A1 and Week 72 in Group B1 and the end of follow-up was defined as Week 72 in Group A1 and Week 96 in Group B1.|Up to Week 96|The ITT population included all participants randomized and allocated to receive treatments.||Percentage of participants||95% Confidence Interval|Number
635306|NCT02641379|Secondary|Number of Participants With Adverse Events and Serious Adverse Events (Part 1)|An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.|Up to Week 96|The safety population included all participants who received at least on dose of (either) study drug and had at least one post-baseline safety assessment.||Number of participants|||Number
635340|NCT02638129|Secondary|Time From Treatment Period Randomization to the Occurrence of Cardiovascular Death||Day 1 to the occurrence of cardiovascular death (up to 6 years)|The trial was prematurely terminated. Due to the short trial duration and as a result of very limited participant follow-up, insufficient data was collected (or did not exist) to allow for a statistical analysis as described in the protocol. The necessary and sufficient data to conduct the primary and secondary analyses was not available.|||||
645343|NCT02181127|Secondary|Average BG as Determined From the Measurements Taken Before Meals and Before Bedtime||2 weeks||||||
635308|NCT02641379|Secondary|Mean Fatigue Severity Scale Scores for Groups A and B Over Time (Part 1)|The Fatigue Severity Scale (FSS) is an instrument consisting of 10 self-administered questions. The FSS items were scored by calculating the average response to all answered items (including the 9 questions and the fatigue symptoms). Each of the 9 questions had answers within a score range of 1-7. A score of 1 for any question indicates less fatigue in everyday life and a score of 7 indicates a higher likelihood of fatigue in everyday life. The mean FSS scores are presented at Baseline (Day 1), Week 24, Week 48 and Week 72 (for Groups A and B) and at Week 96 (for Group B).|Baseline (Day 1), Week 24, Week 48 and Week 72, and Week 96|The ITT population included all participants randomized and allocated to receive treatments. Here, 'n' = the number of participants analyzed at a given time point.||scores on a scale||Standard Deviation|Mean
635309|NCT02641379|Secondary|Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1)|The Short Form-36 (SF-36) is a quality of life instrument consisting of a 36-item questionnaire. The SF-36 items were scored and transformed according to the SF-36 Health Survey Manual and Interpretation Guide. Summary scores for SF-36 dimensions (physical functioning, role functioning, bodily pain, general health, vitality, social functioning, mental health, health transition) as well as physical and mental summary measures were compiled after imputation of mean scores for missing items if more than 50% of dimension-related items were available. Scores for health transition ranged from 0 (worst) to 5 (best). Scores for all other dimensions ranged from 0 (worst) to 100 (best). The mean SF-36 scores are presented at Baseline (Day 1), Week 24, Week 48, Week 72 (for Groups A and B) and at Week 96 (for Group B). Lower score indicate worsening.|Baseline (Day 1), Week 24, Week 48, Week 72, and Week 96|The ITT population included all participants randomized and allocated to receive treatments. Here, 'n' = the number of participants analyzed at a given time point.||scores on a scale||Standard Deviation|Mean
635310|NCT02641379|Secondary|Percentage of Participants Achieving Sustained Virological Response in Groups A, B, C, and D at the End of Follow-up (Part 1)|The SVR was defined as the percentage of participants in each group with a non-detectable HCV RNA result at 24 weeks post-completion of the treatment period (HCV RNA < 15 IU/ml at Week 48 of Group D, at Week 72 of Group A, and at Week 96 of Groups B and C). Participants without a HCV RNA PCR at this time point were considered as non-responders in this calculation. The end of follow-up was defined as Week 72 for Group A, Week 96 for Groups B and C, and Week 48 for Group D.|Up to Week 96|The ITT population included all participants randomized and allocated to receive treatments.||Percentage of participants||95% Confidence Interval|Number
635311|NCT02641379|Secondary|Percentage of Participants With Virological Response Rate in Groups A, B, C, and D at the End of Treatment Period (Part 1)|End of treatment response (ETR) rate was defined as the percentage of participants in each group with non-detectable HCV RNA at completion of the treatment period (HCV negative at Week 24 of Group D, Week 48 of Group A and at Week 72 of Groups B and C). Participants without a HCV RNA results at this time point were considered as non-responders. End of the treatment period was defined as Week 48 for Group A, Week 72 for Groups B and C, and Week 24 for Group D.|Up to Week 72|The ITT population included all participants randomized and allocated to receive treatments.||Percentage of participants||95% Confidence Interval|Number
635312|NCT02641379|Primary|Percentage of Participants Achieving Sustained Virological Response in Groups A1, B1, and E by Genotype at the End of Follow-up (Part 2)|The Sustained Virological Response (SVR) was defined as the percentage of participants in each group with non-detectable HCV RNA result at 24 weeks post completion of the treatment period (HCV RNA < 15 IU/ml at Week 72 of Groups A1 and E, and at Week 96 of Group B1). Participants without a HCV RNA results at this time point were considered as non-responders. The end of follow-up was defined as Week 72 for Groups A1 and E, and Week 96 for Group B1. The SVR for treatment Groups A1 + B1 and E, stratified for genotype (Genotype I and Genotype IV) is presented.|Up to Week 96|The ITT population included all participants randomized and allocated to receive treatments. Here, 'n' = the number of participants analyzed according to genotype.||Percentage of participants||95% Confidence Interval|Number
635313|NCT02641379|Primary|Percentage of Participants With Relapse Rate in Groups A and B by Genotype at the End of Follow-up (Part 1)|Relapse rate (RR) was defined as the percentage of participants with non-detectable HCV RNA (< 100 copies/ml) at the end of treatment and detectable HCV RNA at the end of follow-up. End of treatment was defined as Week 48 for Group A and Week 72 for Group B, respectively. The end of follow-up was defined as Week 72 for Group A and Week 96 for Group B, respectively. Relapse rate for treatment Groups A and B, stratified for genotype (Genotype I and Genotype IV) and Week 4 response (< 600 units/milliliter [U/ml] and >= 600 U/ml) is presented.|Up to Week 96|The ITT population included all participants randomized and allocated to receive treatments. Here, 'n' = number of participants analyzed according to genotype and Week 4 response.||Percentage of participants||95% Confidence Interval|Number
635314|NCT02641249|Secondary|Change in the Total Number of Bradycardia Episodes (<100 Beats Per Minute (Bpm), at Least 5 Seconds Long) During Intervention and Without the Intervention|The total number of bradycardia episodes to <100 bpm lasting >5 seconds/episode will be compared during periods of vibration (intervention) to periods of no vibrations (no intervention).|12 hours of intervention/12 hours of no intervention|Premature neonates (29 +/- 2.5 weeks gestational age at birth), with a diagnosis of apnea of prematurity||bradycardias||Standard Error|Mean
635315|NCT02641249|Secondary|Change in the Total Number of Intermittent Hypoxic Episodes to <90% Lasting >5 Seconds/Episode During the Intervention and Without Intervention|The total number of intermittent hypoxic episodes to <90% (pulse oximetry) lasting >5 seconds/episode will be compared during periods of vibration (intervention) to periods of no vibrations (no intervention).|12 hours of intervention/12 hours of no intervention|Premature neonates (29 +/- 2.5 weeks gestational age at birth), with a diagnosis of apnea of prematurity||IH events||Standard Error|Mean
635316|NCT02641249|Primary|Change in Total Number of Episodes of Apnea/Breathing Pauses During Intervention and Without Intervention|The total number of apneas/breathing pauses will be compared during periods of vibration (intervention) to periods of no vibrations (no intervention).|12 hours of intervention/12 hours of no intervention|Premature neonates (29 +/- 2.5 weeks gestational age at birth), with a diagnosis of apnea of prematurity||breathing pauses||Standard Error|Mean
635322|NCT02640157|Secondary|Percentage of Participants With Post-treatment Relapse|Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment, excluding reinfection.|From the end of treatment through 12 weeks after the last dose of study drug|All participants who received at least 1 dose of study drug, completed treatment, and had HCV RNA <LLOQ at the final treatment visit||percentage of participants||95% Confidence Interval|Number
635323|NCT02640157|Secondary|Percentage of Participants With On-treatment Virologic Failure|On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.|Treatment weeks 1, 2, 4, 8 (end of treatment for Arm C), and 12 (end of treatment for Arms A and B) or premature discontinuation from treatment|All participants who received at least 1 dose of study drug (ITT population)||percentage of participants||95% Confidence Interval|Number
635324|NCT02640157|Secondary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12): Superiority of Arm A to Arm B|SVR12 was defined as plasma HCV RNA level <LLOQ 12 weeks after the last dose of study drug. Per statistical analysis plan to adjust for multiplicity among the primary and first secondary hypothesis tests, the test for superiority of Arm A to Arm B was not conducted.|12 weeks after the last actual dose of study drug|All participants who received at least 1 dose of study drug (ITT population); participants with missing data after backwards imputation were imputed as nonresponders.||percentage of participants||95% Confidence Interval|Number
635325|NCT02640157|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12): Noninferiority of Arm C to Arm A|SVR12 was defined as plasma HCV RNA level <LLOQ 12 weeks after the last dose of study drug. If the first primary efficacy objective (noninferiority of Arm A to Arm B) was achieved, then the second primary efficacy objective, noninferiority in the percentage of participants achieving SVR12 of the 8-week regimen (Arm C) to the 12-week regimen (Arm A) was to be tested. Noninferiority was defined as: a) the lower bound of the 95% CI for the difference was above the noninferiority margin of –6% and the lower bound of the 95% CI for the SVR12 rate within Arm C was greater than 92%, OR b) the lower bound of the 95% CI for the difference was below the noninferiority margin of –6% and the lower bound of the 97.5% CI for the SVR12 rate within Arm C was greater than 92%, OR c) the lower bound of the 97.5% CI for the difference was above the noninferiority margin of –6% and the lower bound of the 95% CI for the SVR12 rate within Arm C was below 92%.|12 weeks after the last actual dose of study drug|All participants who received at least 1 dose of study drug (ITT population); participants with missing data after backwards imputation were imputed as nonresponders.||percentage of participants||95% Confidence Interval|Number
635341|NCT02638129|Secondary|Time From Treatment Period Randomization to the Occurrence of All-Cause Death||Day 1 to the occurrence of all-cause death (up to 6 years)|The trial was prematurely terminated. Due to the short trial duration and as a result of very limited participant follow-up, insufficient data was collected (or did not exist) to allow for a statistical analysis as described in the protocol. The necessary and sufficient data to conduct the primary and secondary analyses was not available.|||||
635367|NCT02634788|Secondary|Percentage of Participants Using Rescue Medication for Pain|The percentage of participants who needed to take an alternate medication for pain relief during the treatment period.|From Time 0 (first dose of study drug) up to 48 hours|All randomized participants from the ITT Population.||percentage of participants|||Number
635326|NCT02640157|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12): Noninferiority of Arm A to Arm B|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ] 12 weeks after the last dose of study drug. The primary efficacy endpoint was noninferiority in the percentage of participants achieving SVR12 of the 12-week regimen (Arm A) to the standard of care (Arm B: 12 weeks of treatment with sofosbuvir [SOF] + daclatasvir [DCV]), defined as: a) the lower bound of the 95% confidence interval (CI) for the difference was above the non-inferiority margin of –6% and the lower bound of the 95% CI for the SVR12 rate within Arm A was greater than 92%; OR b) the lower bound of the 95% CI for the difference was below the non-inferiority margin of –6% and the lower bound of the 97.5% CI for the SVR12 rate within Arm A was greater than 92%; OR c) the lower bound of the 97.5% CI for the difference was above the non-inferiority margin of –6% and the lower bound of the 95% CI for the SVR12 rate within Arm A was below 92%.|12 weeks after the last actual dose of study drug|Intent-to-treat population: all participants who received at least 1 dose of study drug; participants with missing data after backwards imputation were counted as nonresponders.||percentage of participants||95% Confidence Interval|Number
635327|NCT02639052|Secondary|Change in Heat Pain Relief by VAS Pain Intensity Reporting After 1 Week, 1 Month, and 3 Months After Treatment|A secondary endpoint is to see if Botox has a relieving effect on heat pain using a pain visual analog scale (VAS) intensity scale as an outcome measure. The pain VAS intensity scale ranges from a minimum of 0 (no pain - best) to a maximum of 10 (maximum pain - worst). Participants will rate pain intensity after pain is induced with a heat thermode.|Baseline, 1 week, 1 month, 3 months|||units on a scale||Standard Deviation|Mean
635328|NCT02639052|Primary|Itch by VAS Itch Intensity at 3 Months (Visit 4)|The primary endpoint is to test the antipruritic effect of Botox using an itch visual analog scale (VAS) intensity scale as an outcome measure. The itch VAS intensity scale ranges from a minimum of 0 (no itch - best) to a maximum of 10 (maximum itch - worst). Participants will rate itch intensity after itch is induced with cowhage.|3 Months from Baseline|||units on a scale||Standard Deviation|Mean
635329|NCT02639052|Primary|Itch by VAS Itch Intensity at 1 Month (Visit 3)|The primary endpoint is to test the antipruritic effect of Botox using an itch visual analog scale (VAS) intensity scale as an outcome measure. The itch VAS intensity scale ranges from a minimum of 0 (no itch - best) to a maximum of 10 (maximum itch - worst). Participants will rate itch intensity after itch is induced with cowhage.|1 Month from Baseline|||units on a scale||Standard Deviation|Mean
635330|NCT02639052|Primary|Itch by VAS Itch Intensity at 1 Week (Visit 2)|The primary endpoint is to test the antipruritic effect of Botox using an itch visual analog scale (VAS) intensity scale as an outcome measure. The itch VAS intensity scale ranges from a minimum of 0 (no itch - best) to a maximum of 10 (maximum itch - worst). Participants will rate itch intensity after itch is induced with cowhage.|1 week from Baseline|||units on a scale||Standard Deviation|Mean
635331|NCT02639052|Primary|Itch by VAS Itch Intensity at Baseline (Visit 1)|The primary endpoint is to test the antipruritic effect of Botox using an itch visual analog scale (VAS) intensity scale as an outcome measure. The itch VAS intensity scale ranges from a minimum of 0 (no itch - best) to a maximum of 10 (maximum itch - worst). Participants will rate itch intensity after itch is induced with cowhage.|Baseline (Visit 1)|||units on a scale||Standard Deviation|Mean
635332|NCT02638493|Secondary|Emtricitabine Triphosphate (FTCtp)/Deoxyadenosine Triphosphate (dCTP) Ratio in Seminal Mononuclear Cells|dCTP concentrations in seminal mononuclear cells will be measured and compared to emtricitabine triphosphate concentrations, using a ratio, and summarized descriptively for each subject, as well as across subjects. As the six seminal cell samples collected per man were pooled for analysis due to low cell recovery, a single ratio value per participant was calculated and summarized by study arm.|Average concentration in a 24 hour dosing interval|||FTCtp:dCTP ratio||Inter-Quartile Range|Median
635333|NCT02638493|Secondary|Tenofovir Diphosphate (TFVdp)/Deoxyadenosine Triphosphate (dATP) Ratio in Seminal Mononuclear Cells|dATP concentrations in seminal mononuclear cells will be measured and compared to tenofovir diphosphate concentrations, using a ratio, and summarized descriptively for each subject, as well as across subjects. As the six seminal cell samples collected per man were pooled for analysis due to low cell recovery, a single ratio value per participant was calculated and summarized by study arm.|Average concentration in a 24 hour dosing interval|||TFVdp:dATP ratio||Inter-Quartile Range|Median
635334|NCT02638493|Primary|Peripheral Blood Mononuclear Cell (PBMC) Clearance (CL) of Emtricitabine Triphosphate|Samples will be analyzed for drug concentration at the following time points post dose: 3, 6, 9, 12, 18 and 24 hours, and used to estimate the clearance of emtricitabine triphosphate, an intracellular metabolite of emtricitabine, from peripheral blood mononuclear cells, following a 200mg dose of emtricitabine.|Samples collected at 3, 6, 9, 12, 18 and 24 hours post-dose|||fmol/10 E6 cells||Inter-Quartile Range|Median
635335|NCT02638493|Primary|Peripheral Blood Mononuclear Cell (PBMC) Clearance (CL) of Tenofovir Diphosphate|Samples will be analyzed for drug concentration at the following time points post dose: 3, 6, 9, 12, 18 and 24 hours, and used to estimate the clearance of tenofovir diphosphate, an intracellular metabolite of tenofovir, from peripheral blood mononuclear cells, following a 300mg dose of tenofovir.|Samples collected at 3, 6, 9, 12, 18 and 24 hours post-dose|||fmol/10 E6 cells||Inter-Quartile Range|Median
635336|NCT02638493|Primary|Semen Clearance (CL) of Emtricitabine Triphosphate|Samples will be analyzed for drug concentration at the following time points post dose: 3, 6, 9, 12, 18 and 24 hours, and used to estimate the clearance of emtricitabine triphosphate, an intracellular metabolite of emtricitabine, from seminal mononuclear cells, following a 200mg dose of emtricitabine.|Samples collected at 3, 6, 9, 12, 18 and 24 hours post-dose|Semen (SMC) Steady State Concentrations (Css,ave) of Emtricitabine Triphosphate||fmol/10 E6 cells||Inter-Quartile Range|Median
635337|NCT02638493|Primary|Semen Clearance (CL) of Tenofovir Diphosphate|Samples will be analyzed for drug concentration at the following time points post dose: 3, 6, 9, 12, 18 and 24 hours, and used to estimate the clearance of tenofovir diphosphate, an intracellular metabolite of tenofovir, from seminal mononuclear cells, following a 300mg dose of tenofovir.|Samples collected at 3, 6, 9, 12, 18 and 24 hours post-dose|||fmol/10x6 cells||Inter-Quartile Range|Median
635338|NCT02638493|Primary|Semen Clearance (CL) of Emtricitabine|Samples will be analyzed for drug concentration at the following time points post dose: 3, 6, 9, 12, 18 and 24 hours, and used to estimate clearance from semen from a 200mg dose of emtricitabine.|Samples collected at 3, 6, 9, 12, 18 and 24 hours post-dose|||L/hr||Inter-Quartile Range|Median
635342|NCT02638129|Secondary|Time From Treatment Period Randomization to the First Confirmed Occurrence of Extended Major Adverse Cardiovascular Events (MACE)|Extended MACE defined as cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and unstable angina requiring hospitalization.|Day 1 to first confirmed occurrence of extended MACE (up to 6 years)|The trial was prematurely terminated. Due to the short trial duration and as a result of very limited participant follow-up, insufficient data was collected (or did not exist) to allow for a statistical analysis as described in the protocol. The necessary and sufficient data to conduct the primary and secondary analyses was not available.|||||
635343|NCT02638129|Primary|Time From Treatment Period Randomization to the First Confirmed Occurrence of Major Adverse Cardiovascular Events (MACE)|MACE are defined as cardiovascular death, nonfatal myocardial infarction and nonfatal stroke.|Day 1 to first confirmed occurrence of MACE (up to 6 years)|The trial was prematurely terminated. Due to the short trial duration and as a result of very limited participant follow-up, insufficient data was collected (or did not exist) to allow for a statistical analysis as described in the protocol. The necessary and sufficient data to conduct the primary and secondary analyses was not available.|||||
635344|NCT02638051|Secondary|Quality of Life (QoL)|"Karnofsky Performance Score Improvement Rate (KPS IR)
Improvement: increase of KPS for ≥10% after treatment.
Worsening: reduction of KPS for ≥10% after treatment.
NC: change of KPS for <10%."|8 weeks after start of treatment (4 weeks on completion of treatment)|||percentage of participants|||Number
635345|NCT02638051|Secondary|Adverse Events Rate (AER)|Common Terminology Criteria for Adverse Events (CTCAE) (v4.03: June 14, 2010) U.S.DEPARTMENT OF HEALTH AND HUMAN SERVICES, National Institutes of Health, National Cancer Institute.|During 4 weeks of treatment course and 4 weeks after treatment|||participants|||Number
635346|NCT02638051|Primary|Objective Response Rate (ORR)|"Objective Response Rate (ORR) = Complete Remission (CR) + Partial Remission (PR)
WHO criteria of therapeutic effect evaluation at malignant ascites:
Complete Remission (CR): complete absorption of ascites with no obvious regeneration for more than 1 month.
Partial Remission (PR): more than 50% reduction of ascites, with obvious relief of abdominal distention, with maintenance of less than moderate volume of ascites under ultrasound detection for more than 1 month.
No Change (NC): less than 50% reduction of ascites, or no obvious reduction of ascites under ultrasound detection, or even increase of ascites, with obvious abdominal distention."|8 weeks after start of treatment (4 weeks on completion of treatment)|||percentage of participants|||Number
635347|NCT02637063|Secondary|Self-reported Self-efficacy for Lifestyle Behaviors|Five items assessed participants’ confidence to engage in JNC-recommended healthy behaviors using a 5-item response option (1=not at all confident (min), 5=very confident (max)). Mean score is reported, with higher scores indicating higher self-efficacy. The scale showed good reliability (alpha=.79).|Baseline, 12 weeks, 24 weeks|||units on a Likert-type scale||Standard Deviation|Mean
635348|NCT02637063|Secondary|Self-reported Lifestyle Change Preparation Behaviors|Participants were asked to self-report on days in the past two weeks in which they engaged in specific behaviors to prepare for or support healthy eating and physical activity (i.e., “preparation behaviors”). The scale comprised 15 items (e.g., thought about what you might do to try to lose weight) assessed on a 5-point scale (1=none (min), 5=12-14 days (max)). Mean score is reported, with higher scores indicating more frequent preparation behaviors. The scale showed good reliability (alpha=.91).|Baseline, 12 weeks, 24 weeks|||units on a Likert scale||Standard Deviation|Mean
635349|NCT02637063|Primary|Heart-unhealthy Dietary Intake (Self-reported Number of Fat Servings, Red Meat Servings, Dairy Fat Servings)|Participants were asked about their diet during the past month, using DASH-diet related items adapted from several validated food frequency questionnaires. Participants reported on servings consumed (e.g., never, 1-3 times last month, up to 5 or more times a day) of the following foods: fruits, vegetables, dairy, fats and meat. Number of servings was computed for heart-unhealthy foods (red, processed and high-fat prepared meats).|Baseline, 12 weeks, 24 weeks|||Servings||Standard Deviation|Mean
635350|NCT02637063|Primary|Heart-healthy Dietary Intake (Number of Fruit/Vegetable Servings, White Meat Servings, Low-fat Dairy Servings)|Participants were asked about their diet during the past month, using DASH-diet related items adapted from several validated food frequency questionnaires. Participants reported on servings consumed (e.g., never, 1-3 times last month, up to 5 or more times a day) of the following foods: fruits, vegetables, dairy, fats and meat. Number of servings was computed for heart-healthy foods (fruits, vegetables and lean meats).|Baseline, 12 weeks, 24 weeks|||Servings||Standard Deviation|Mean
635351|NCT02637063|Primary|Body Weight|Body weight measurements were taken by participants using a validated, WIFI-enabled weight scale manufactured by BlipCare and provided to study subjects prior to the baseline assessment. Measurements were automatically uploaded over a WIFI connection to the BlipHub app and study outcomes database. Participants were instructed to take weight measurements at the same time of day each time, preferably first thing in the morning after using the bathroom and before eating or drinking. The weight measurement taken on the date and time closest to the completion date and time of each individual’s online survey for that assessment point was analyzed. If no measurements were available within two weeks on either side of that date, weight measurements were considered missing for that assessment period.|Baseline, 12 weeks, 24 weeks|||Pounds||Standard Deviation|Mean
635352|NCT02637063|Primary|Diastolic Blood Pressure|Blood pressure measurements were taken by participants using a validated, WIFI-enabled blood pressure cuff manufactured by BlipCare and provided to study subjects prior to the baseline assessment. Measurements were automatically uploaded over a WIFI connection to the BlipHub app and study outcomes database. Participants followed a standardized measurement protocol based on the American Heart Association protocol for home blood pressure measurement, involving three consecutive measurements, taken one minute apart after a five-minute seated resting period. Measurements were not observed.|Baseline, 12 weeks, 24 weeks|||mm Hg||Standard Deviation|Mean
635353|NCT02637063|Primary|Systolic Blood Pressure|Blood pressure measurements were taken by participants using a validated, WIFI-enabled blood pressure cuff manufactured by BlipCare and provided to study subjects prior to the baseline assessment. Measurements were automatically uploaded over a WIFI connection to the BlipHub app and study outcomes database. Participants followed a standardized measurement protocol based on the American Heart Association protocol for home blood pressure measurement, involving three consecutive measurements, taken one minute apart after a five-minute seated resting period. Measurements were not observed.|Baseline, 12 weeks, 24 weeks|||mm Hg||Standard Deviation|Mean
645344|NCT02181127|Secondary|Number of Hypoglycemic Events as Determined From BG Measurements||2 weeks||||||
635354|NCT02636907|Secondary|The Proportion of Patients With Drug-related Adverse Events Per Investigator Assessment|A treatment-related TEAE was defined as any TEAE assessed by the investigator as related to the trial medication. Data is reported for the autoinjector assessment period. TEAEs were defined as AEs that started or worsened on or after the first dose of trial medication during the treatment period and prior to the last date of trial medication during treatment period + 10 weeks (70 days) inclusive. The autoinjector assessment period started on the first autoinjector administration date (Day 1 visit) and ended on Day 50 visit date (included). If a TEAE occurred in the 10 weeks after the last autoinjector administration but prior to the first injection during the extension phase, it was to be accounted for in the autoinjector assessment period.|Up to 17 weeks.|Safety Analysis Set (SAF): The SAF contained all patients in the all subjects enrolled set (ENR) who received at least 1 dose of trial drug or attempted to inject it as indicated by the questionnaire on self-injection with autoinjector.||Percentage of participants|||Number
635355|NCT02636907|Secondary|The Proportion of Patients With Local Injection Site Reactions|"Qualified trial site personnel contacted the patient 48 hours after each self-injection during the autoinjector assessment period to collect all Adverse Events (AEs), including injection-site reactions. Data is reported as Treatment-Emergent AEs (TEAEs), defined as AEs that started or worsened on or after the first dose of trial medication during the treatment period and prior to the last date of trial medication during treatment period + 10 weeks (70 days) inclusive. The autoinjector assessment period started on the first autoinjector administration date (Day 1 visit) and ended on Day 50 visit date (included). If a TEAE occurred in the 10 weeks after the last autoinjector administration but prior to the first injection during the extension phase, it was to be accounted for in the autoinjector assessment period.
Percentage of subjects calculated relative to the total number of subjects in the analysis set."|Up to 17 weeks.|Safety Analysis Set (SAF): The SAF contained all patients in the all subjects enrolled set (ENR) who received at least 1 dose of trial drug or attempted to inject it as indicated by the questionnaire on self-injection with autoinjector.||Percentage of participants|||Number
635356|NCT02636907|Secondary|Frequency of Any Autoinjector Handling Events|"An autoinjector handling event included any one of the following events which prevented the patient from successfully self-injecting the full content of the autoinjector and which occurred after the training self-injection up to the EoT Visit: removing the cap of the autoinjector (3a); pressing the injection button of the autoinjector (3b); or holding the autoinjector down against the skin until the injection is completed (3c).
Percentage of injections was calculated relative to the total number of injections (both unsuccessful and successful)."|Day 50.|Safety Analysis Set (SAF): The SAF contained all patients in the all subjects enrolled set (ENR) who received at least 1 dose of trial drug or attempted to inject it as indicated by the questionnaire on self-injection with autoinjector.||Percentage of injections|||Number
635357|NCT02636907|Primary|Autoinjector Assessment Period: Percentage of Successful Self-injections as Reported in the Questionnaires Completed by Both the Trial Site Personnel and the Patient Analysing All Self-injections|"All self-injections occurring after the training self-injection up to the End of Trial (EoT) visit were analyzed. Successful self-injections were based on the response to Question 2 on the questionnaire, which queried whether the full content of the autoinjector was injected into the body. An injection was considered successful when both the patient and the qualified trial site personnel responded yes to the Question 2 on their respective questionnaires. If they responded no to Question 2, patients and trial site personnel were instructed to also answer Question 3, which asked what prevented the patient for injecting the full contents of the autoinjector.
Percentage of injections calculated relative to the total number of first injections."|Day 50.|Safety Analysis Set (SAF): The SAF contained all patients in the all subjects enrolled set (ENR) who received at least 1 dose of trial drug or attempted to inject it as indicated by the questionnaire on self-injection with autoinjector.||Percentage of injections||95% Confidence Interval|Number
635358|NCT02636595|Secondary|Percentage of Participants With Post-treatment Relapse|Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment, excluding reinfection.|From the end of treatment through 12 weeks after the last dose of study drug|All participants who received at least 1 dose of study drug, completed treatment, and had HCV RNA <LLOQ at the final treatment visit.||percentage of participants||95% Confidence Interval|Number
635359|NCT02636595|Secondary|Percentage of Participants With On-treatment Virologic Failure|On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.|Treatment weeks 1, 2, 4, 8, and 12 (end of treatment) or premature discontinuation from treatment|All participants who received at least 1 dose of study drug (ITT population).||percentage of participants||95% Confidence Interval|Number
635360|NCT02636595|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of study drug|Intent-to-treat (ITT) population: all participants who received at least 1 dose of study drug; participants with missing data after backwards imputation were imputed as nonresponders.||percentage of participants||95% Confidence Interval|Number
635361|NCT02635828|Secondary|Incidence of Subjects Significant QTc Changes in the EKG|The incidence of significant QTc prolongation was measured by comparing baseline EKG, 24 hours and 120 hours after surgery|24 and 120 hours/discharge after end of surgery|||participants|||Number
635362|NCT02635828|Primary|PONV Incidence|The incidence of PONV|24 hours after end of surgery|Incidence of PONV||participants|||Number
635363|NCT02635425|Primary|Number of Participants of Severe Ovarian Hyperstimulation Syndrome||2 weeks|||participants|||Number
635364|NCT02634788|Secondary|Participant's Global Evaluation of Study Drug|Global evaluation of study drug was completed at the end of treatment (Day 3) or before early termination if a participant discontinued early. Participants were asked to provide an overall rating of their study medication in controlling pain on a 5-point NRS, where 0=poor, 1=fair, 2=good, 3=very good, and 4=excellent. The percentage of participants with scores in each pain relief category are reported.|End of treatment (Day 3) or early termination|All randomized participants from the ITT Population.||percentage of participants|||Number
645345|NCT02181127|Secondary|MARD vs. All BG Measurements||2 weeks||||||
635368|NCT02634788|Secondary|Time to Meaningful Pain Relief|Time to meaningful pain relief was evaluated using the 2 stopwatch method and is defined as the time when the participant stops the second stopwatch. If it was not stopped time was censored at the time that the second stopwatch was stopped or the time of the second dose or the time that rescue medication was used whichever came first.|From Time 0 (first dose of study drug) to time of meaningful pain relief (up to 227 minutes)|All randomized participants from the ITT Population.||minutes||95% Confidence Interval|Median
635369|NCT02634788|Secondary|Time to First Perceptible Pain Relief|Time to first perceptible pain relief was evaluated using the 2 stopwatch method and is defined as the time when the participant stops the first stopwatch. If it was not stopped time was censored at the time that the second stopwatch was stopped or the time of the second dose or the time that rescue medication was used whichever came first.|From Time 0 (first dose of study drug) to time of first perceptible pain relief (up to 83 minutes)|All randomized participants from the ITT Population.||minutes||95% Confidence Interval|Median
635370|NCT02634788|Secondary|Time to Peak Pain Relief|Time to peak pain relief is the time to the highest value of pain relief experienced during the study. Pain relief was assessed by the participant using a 5-point NRS (0=no relief, 1=a little, 2=some, 3=a lot, 4=complete relief). If no pain relief was observed, then the time was censored at the time of the last pain assessment.|From Time 0 (first dose of study drug) to time of peak pain relief (up to 1437 minutes)|All randomized participants from the ITT Population||minutes||95% Confidence Interval|Median
635371|NCT02634788|Secondary|Percentage of Participants With Peak Scores in Each Pain Relief Category|Peak pain relief is the highest value of pain relief experienced during the study. Pain relief was assessed by the participant using a 5-point NRS (0=no relief, 1=a little, 2=some, 3=a lot, 4=complete relief). The percentage of participants with peak scores in each pain relief category are reported.|From Time 0 (first dose of study drug) up to 48 hours|All randomized participants from the ITT Population||percentage of participants|||Number
635372|NCT02634788|Secondary|Percentage of Participants With Scores in Each Pain Relief Category at 4, 8, 24 and 48 Hours After Time 0|Pain relief was assessed by the participant using a 5-point NRS (0=no relief, 1=a little, 2=some, 3=a lot, 4=complete relief). The percentage of participants with scores in each pain relief category are reported. Missing values were imputed.|4, 8, 24 and 48 hours after Time 0 (first dose of study drug)|All randomized participants from the ITT Population||percentage of participants|||Number
635373|NCT02634788|Secondary|Time to Onset of Analgesia|Time to onset of analgesia was measured as time to first perceptible pain relief confirmed by meaningful pain relief using the 2-stopwatch method. The study staff started 2 stopwatches as soon as the first dose of study drug was administered. Each participant was instructed to stop the first stopwatch when he or she experienced any perceptible pain relief and the second stopwatch when he or she experienced pain relief that was meaningful to them. If the second stopwatch was not stopped, time was censored at the time of the second dose of study drug or the use of rescue medication, whichever came first. If both stopwatches were not stopped time was censored at the time of the second dose of study drug or the use of rescue medication whichever came first. Time to onset of analgesia was defined as the time when the first stopwatch was stopped given that the second stopwatch is stopped.|From Time 0 (first dose of study drug) to time of confirmed meaningful pain relief (up to 64 minutes)|All randomized participants from the ITT Population.||minutes||95% Confidence Interval|Median
635374|NCT02634788|Secondary|Total Pain Relief (TOTPAR) Over 4, 8, 24 and 48 Hours After Time 0|TOTPAR was assessed by the participant using a 5-point NRS (0=no relief, 1=a little, 2=some, 3=a lot, 4=complete relief). TOTPAR scores were collected at Baseline (prior to study drug) and at multiple time points up to 48 hours after Time 0 (first dose of study drug). The TOTPAR scores are the sum of the pain relief at each time point multiplied by the duration in hours since the previous time point. Larger positive numbers indicate more pain relief (maximum=4 at each time point) and smaller positive numbers indicate less pain relief (minimum=0 at each time point). The overall minimum is 0 for each variable and the overall maximum is 4 times the number of hours specified for the variable: TOTPAR-4=(0 to 16), TOTPAR-8=(0 to 32), TOTPAR-24=(0 to 96) and TOTPAR-48=(0 to 192). TOTPAR-4, TOTPAR-8, TOTPAR-24 and TOTPAR-48 were analyzed using an ANCOVA model with factors for treatment, site and baseline pain intensity.|4, 8, 24 and 48 hours after Time 0|All randomized participants from the ITT Population with data available at each timepoint.||units on a scale||Standard Error|Least Squares Mean
635375|NCT02634788|Secondary|NRS SPID Over 4 Hours (SPID-4), 8 Hours (SPID-8) and 24 Hours (SPID-24) After Time 0|Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug) and at multiple time points up to 48 hours after Time 0 (administration of first dose of study drug). Pain intensity difference is calculated by subtracting the pain intensity at each time point from the pain intensity at Time 0. The SPID scores are the sum of the differences at each time point multiplied by the duration in hours since the previous time point. Positive numbers indicate a reduction in pain [max=10 at each time point] and negative numbers indicate an increase in pain [min=-10 at each time point]. The overall min and max are -10 and 10 times the number of hours specified: SPID-4=(-40 to 40), SPID-8=(-80 to 80) and SPID-24=(-240 to 240). The NRS SPID-4, 8 and 24 were analyzed using an ANCOVA model which included treatment and site as main effects and Baseline pain intensity as the covariate.|Baseline and 0 to 4, 0 to 8 and 0 to 24 hours after Time 0|All randomized participants from the Intent-to-Treat (ITT) Population who did not have missing SPID values.||units on a scale||Standard Deviation|Least Squares Mean
635376|NCT02634788|Secondary|NRS Mean Pain Intensity Score at 4, 8, 24 and 48 Hours After Time 0|Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug administration) and at multiple time points up to 48 hours after Time 0 (time of administration of the first dose of study drug). A lower value indicates improvement in pain.|4, 8, 24 and 48 hours after Time 0|All randomized participants from the ITT Population with data available at each timepoint.||units on a scale||Standard Deviation|Mean
635387|NCT02634073|Secondary|Change From Baseline in Hematocrit|Blood samples were collected at Day -1, Day 3 of every treatment period and at follow-up. Change from Baseline for hematocrit was calculated as the post-dose visit value minus the value at Baseline, at Day 3 and Follow-up. Baseline value used in the analysis was the latest pre-dose values on Day 1 of each treatment/period. Day -1 presented the Baseline absolute values; Day 3 and Follow-Up presented the changes from Baseline.|Baseline and up to 5 weeks|Safety Population||Fraction of 1||Standard Deviation|Mean
635377|NCT02634788|Secondary|NRS Mean Pain Intensity Difference (PID) at 4, 8, 24 and 48 Hours After Time 0|Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug administration) and at multiple time points up to 48 hours after Time 0 (time of administration of the first dose of study drug). NRS PID is defined as the difference in pain at each scheduled timepoint relative to Baseline (PID=pain intensity at baseline – pain intensity at time point). A higher value of NRS PID score indicates a higher decrease in pain from Baseline.|Baseline and 4, 8, 24 and 48 hours after Time 0|All randomized participants from the ITT Population with data available at each timepoint.||units on a scale||Standard Deviation|Mean
635378|NCT02634788|Primary|Numeric Rating Scale (NRS) Summed Pain Intensity Difference (SPID) Over 0 to 48 Hours After Time 0 (NRS SPID-48)|Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug) and at multiple time points up to 48 hours after Time 0 (administration of first dose of study drug). Pain intensity difference is calculated by subtracting the pain intensity at each time point from the pain intensity at Time 0. The SPID scores are the sum of the differences at each time point multiplied by the duration in hours since the previous time point. Positive numbers indicate a reduction in pain [maximum(max)=10 at each time point], and negative numbers indicate an increase in pain [minimum(min)=-10 at each time point]. The overall min and max are -10 and 10 times the number of hours specified; SPID-48 range is -480 to 480. The NRS SPID-48 was analyzed using an analysis of covariance (ANCOVA) model, which included treatment and site as main effects and Baseline pain intensity as the covariate.|Baseline and 0 to 48 hours after Time 0|All randomized participants from the Intent-to-Treat (ITT) Population who did not have missing SPID-48 values. Missing SPID-48 data were not imputed.||units on a scale||Standard Error|Least Squares Mean
635379|NCT02634073|Secondary|Change From Baseline in Albumin|Blood samples were collected at Day -1, Day 3 of every treatment period and at follow-up. Change from Baseline for albumin was calculated as the post-dose Visit Value minus the value at Baseline, at Day 3 and Follow-up. Baseline value used in the analysis was the latest pre-dose values on Day 1 of each treatment/Period. Day -1 presented the Baseline absolute values; Day 3 and Follow-Up presented the changes from Baseline.|Baseline and up to 5 weeks|Safety Population||G//L||Standard Deviation|Mean
635380|NCT02634073|Secondary|Change From Baseline in Creatinine, Total Bilirubin and Direct Bilirubin|Blood samples were collected at Day -1, Day 3 of every treatment period and at follow-up. Change from Baseline for creatinine and direct bilirubin were calculated as the post-dose visit value minus the value at Baseline, at Day 3 and Follow-up. Baseline value used in the analysis was the latest pre-dose values on Day 1 of each treatment/period. Change from Baseline in total bilirubine was not assessed. Day -1 presented the Baseline absolute values; Day 3 and Follow-Up presented the changes from Baseline.|Baseline and up to 5 weeks|Safety Population||micromole (umol)/L||Standard Deviation|Mean
635381|NCT02634073|Secondary|Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphates|Blood samples were collected at Day -1, Day 3 of every treatment period and at follow-up. Change from Baseline for AST, ALT and alkaline phosphatase were calculated as the post-dose visit value minus the value at Baseline, at Day 3 and Follow-up. Baseline value used in the analysis was the latest pre-dose values on Day 1 of each treatment/period. Day -1 presented the Baseline absolute values; Day 3 and Follow-Up presented the changes from Baseline.|Baseline and up to 5 weeks|Safety Population||Unit (U)/L||Standard Deviation|Mean
635382|NCT02634073|Secondary|Change From Baseline in Blood Urea Nitrogen (BUN), Sodium, Potassium, Glucose, Calcium|Blood samples were collected at Day -1, Day 3 of every treatment period and at follow-up. Change from Baseline for BUN, sodium, potassium, glucose, calcium were calculated as the post-dose visit value minus the value at Baseline, at Day 3 and Follow-up. Baseline value used in the analysis was the latest pre-dose values on Day 1 of each treatment/period. Day -1 presented the Baseline absolute values; Day 3 and Follow-Up presented the changes from Baseline.|Baseline and up to 5 weeks|Safety Population||millimole (mmol)/L||Standard Deviation|Mean
635383|NCT02634073|Secondary|Change From Baseline in Platelets, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils|Blood samples were collected at Day -1, Day 3 of every treatment period and at follow-up. Change from Baseline for platelets, neutrophils, lymphocytes, monocytes, eosinophils, basophils were calculated as the post-dose visit value minus the value at Baseline, at Day 3 and Follow-up. Baseline value used in the analysis was the latest pre-dose values on Day 1 of each treatment/period. Day -1 presented the Baseline absolute values; Day 3 and Follow-Up presented the changes from Baseline.|Baseline and up to 5 weeks|Safety Population||10^9 cells/L||Standard Deviation|Mean
635384|NCT02634073|Secondary|Change From Baseline in Mean Corpuscular Volume (MCV)|Blood samples were collected at Day -1, Day 3 of every treatment period and at follow-up. Change from Baseline for MCV was calculated as the post-dose visit value minus the value at Baseline, at Day 3 and Follow-up. Baseline value used in the analysis was the latest pre-dose values on Day 1 of each treatment/period. Day -1 presented the Baseline absolute values; Day 3 and Follow-Up presented the changes from Baseline.|Baseline and up to 5 weeks|Safety Population||Femtoliter||Standard Deviation|Mean
635385|NCT02634073|Secondary|Change From Baseline in Mean Corpuscular Hemoglobin (MCH)|Blood samples were collected at Day -1, Day 3 of every treatment period and at follow-up. Change from Baseline for MCH was calculated as the post-dose visit value minus the value at Baseline, at Day 3 and Follow-up. Baseline value used in the analysis was the latest pre-dose values on Day 1 of each treatment/period. Day -1 presented the Baseline absolute values; Day 3 and Follow-Up presented the changes from Baseline.|Baseline and up to 5 weeks|Safety Population||Picogram||Standard Deviation|Mean
635386|NCT02634073|Secondary|Change From Baseline in Hemoglobin|Blood samples were collected at Day -1, Day 3 of every treatment period and at follow-up. Change from Baseline for hemoglobin was calculated as the post-dose visit value minus the value at Baseline, at Day 3 and Follow-up. Baseline value used in the analysis was the latest pre-dose values on Day 1 of each treatment/period. Day -1 presented the Baseline absolute values; Day 3 and Follow-Up presented the changes from Baseline.|Baseline and up to 5 weeks|Safety Population||G/L||Standard Deviation|Mean
635415|NCT02630563|Secondary|Time to Maximum Plasma Concentration for Mycophenolic Acid and Mycophenolic Acid Glucuronide|Tmax is the amount of time after dosing to when the maximum concentration of MPA and MPAG was achieved.|Pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 4.0, 8.0, and 12.0 hours post oral dosing for participants > 24 months, and at pre-dose, 0.75, 2.0, 4.0 and 12.0 hours post oral dosing for participants < 24 months|The PK population was used for the analysis.||hour||Full Range|Median
635388|NCT02634073|Secondary|Change From Baseline in Erythrocytes|Blood samples were collected at Day -1, Day 3 of every treatment period and at follow-up. Change from Baseline for erythrocytes was calculated as the post-dose visit value minus the value at Baseline, at Day 3 and Follow-up. Baseline value used in the analysis was the latest pre-dose values on Day 1 of each treatment/Period. Day -1 presented the Baseline absolute values; Day 3 and Follow-Up presented the changes from Baseline.|Baseline and up to 5 weeks|Safety Population||10^12 cells/L||Standard Deviation|Mean
635389|NCT02634073|Secondary|Number of Participants With Treatment Emergent Laboratory Abnormality Grade|Division of Acquired immune deficiency syndrome (DAIDS) Table AE grades 1, 2, 3, and 4 of laboratory abnormalities were applied and grade were summarized by treatment and day and were listed by participant, treatment, day, and actual date and time. Treatment emergent grades are defined as any new toxicity grades or the worsened grades compared to Baseline grade. Treatment emergent lab abnormality Grade 1 for aspartate aminotransferase and sodium at follow-up visit are summarized.|Up to Week 5|Safety Population||Participants|||Number
635390|NCT02634073|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Change from Baseline for DBP and SBP was calculated as the post-dose visit value minus the value at Baseline, at Day 3 and Follow-up. Baseline value used in the analysis was the latest pre-dose values on Day 1 of each treatment/period.|Baseline and up to 5 weeks|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).||millimeter of mercury (mmHg)||Standard Deviation|Mean
635391|NCT02634073|Secondary|Change From Baseline in Body Temperature|Change from Baseline for body temperature was calculated as the post-dose visit value minus the value at Baseline, at Day 3 and Follow-up. Baseline value used in the analysis was the latest pre-dose values on Day 1 of each treatment/period.|Baseline and up to 5 weeks|Safety Population||Degree centigrade||Standard Deviation|Mean
635392|NCT02634073|Secondary|Change From Baseline in Pulse Rate|Change from Baseline for pulse rate was calculated as the post-dose visit value minus the value at Baseline, at Day 3 and Follow-up. Baseline value used in the analysis was the latest pre-dose values on Day 1 of each treatment/period.|Baseline and up to 5 weeks|Safety Population.Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).||Beats/min||Standard Deviation|Mean
635393|NCT02634073|Secondary|Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAE)|An AE is any untoward medical occurrence, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect or event that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition.|Up to 5 Weeks|Safety Population: defined as all participants who enrolled into the study and received at least one dose of study drug.||Participants|||Number
635394|NCT02634073|Primary|Time to Observed Maximum Lamivudine Plasma Concentration (Tmax), Time of Last Measurable Plasma Concentration (Tlast) and Absorption Lag Time in Plasma (Tlag)|Serial blood sample were collected at Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post-dose in each treatment period.|Day 1 to Day 3 in each treatment period|||Hr||Full Range|Median
635395|NCT02634073|Primary|Plasma Lamivudine Apparent Oral Clearance (CL/F)|Serial blood sample were collected at Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post-dose in each treatment period. ANOVA, considering treatment and period as fixed effects and participant as random effect, was performed using Mixed Linear Models procedure to compare the plasma lamivudine CL/F|Day 1 to Day 3 in each treatment period|PK Summary Population||Liter (L)/hr||Geometric Coefficient of Variation|Geometric Mean
635396|NCT02634073|Primary|Lamivudine Elimination Half-life in Plasma (t1/2)|Serial blood sample were collected at Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post-dose in each treatment period. ANOVA, considering treatment and period as fixed effects and participant as random effect, was performed using Mixed Linear Models procedure to compare the plasma lamivudine t1/2.|Day 1 to Day 3 in each treatment period|PK Summary Population||Hour (Hr)||Geometric Coefficient of Variation|Geometric Mean
635397|NCT02634073|Primary|Plasma Lamivudine Maximum Observed Concentration (Cmax), Concentration at 24 Hour (h) Post-dose (C24) and Last Measurable Concentration (Ct)|Serial blood sample were collected at Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post-dose in each treatment period. Time of the last measurable concentration (t) was 48 hours for all participants and all treatments. ANOVA, considering treatment and period as fixed effects and participant as random effect, was performed using Mixed Linear Models procedure to compare the plasma lamivudine PK parameters.|Day 1 to Day 3 in each treatment period|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
635398|NCT02634073|Primary|Plasma Lamivudine Area Under the Plasma Concentration Time Curve (AUC) From Time Zero to the Last Quantifiable Time Point (AUC[0-t]), AUC From Time Zero Extrapolated to Infinity (AUC[0-inf]) and AUC From Time Zero to 24 Hours (AUC[0-24])|Serial blood sample were collected at Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post-dose in each treatment period. AUC was determined using the trapezoidal rule. Analysis of variance (ANOVA), considering treatment and period as fixed effects and participant as random effect, was performed using Mixed Linear Models procedure to compare the plasma lamivudine Pharmacokinetic (PK) parameters.|Day 1 to Day 3 in each treatment period|PK Summary Population: defined as participants who had valid lamivudine PK parameter estimates from both reference and test treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).||hour (h)*microgram (mcg)/milliliter (mL)||Geometric Coefficient of Variation|Geometric Mean
635399|NCT02633787|Primary|Geometric Mean Titers of Meningococcal Antibodies Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination|Anti-meningococcal antibody titers for serogroups A, C, Y, and W-135 were measured using a serum bactericidal assay with human complement.|Pre-booster, 28 Days and 4 years post-booster vaccination|Anti-meningococcal antibody titers were assessed in the Per-Protocol Analysis Set.||Titers (1/dilution)||95% Confidence Interval|Geometric Mean
635475|NCT02627144|Primary|Overall Survival (OS) Time|OS time is defined as time between start of therapy and date of death. Kaplan-Meier estimate was used for evaluation.|Baseline until progression or intolerable toxicity or death, whichever occurred first, assessed up to 6 years|FAS||months||95% Confidence Interval|Median
635400|NCT02633787|Primary|Percentage of Participants With Meningococcal Antibody Titers ≥ 1:8 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination|Anti-meningococcal antibody titers for serogroups A, C, Y, and W-135 were measured using a serum bactericidal assay with human complement.|Pre-booster vaccination, 28 days and 4 years post-booster vaccination|Anti-meningococcal antibody titers were assessed in the Per-Protocol Analysis Set.||Percentage of participants|||Number
635401|NCT02633787|Primary|Percentage of Participants With Meningococcal Antibody Titers ≥ 1:4 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination.|Anti-meningococcal antibody titers for serogroups A, C, Y, and W-135 were measured using a serum bactericidal assay with human complement.|Pre-booster vaccination, 28 days, and 4 years post-booster vaccination|Anti-meningococcal antibody titers were assessed in the Per-Protocol Analysis Set.||Percentage of participants|||Number
635402|NCT02633215|Secondary|Change in Wolf Motor Function Test (WMFT)|Score at post-intervention minus baseline, score at 1-month follow-up minus baseline. Each task is scored as amount of time taken to complete a task, which may range from just over 0 to 120 seconds. If the subject is unable to complete the task within 120 seconds, a score of 121 seconds is given. The scores from the 15 individual tasks are averaged, then the log is taken, resulting in the overall score. Therefore, the larger the score, the longer required to perform the tasks. Negative changes in score indicate that a subject, on average, was able to complete the tasks faster at post-intervention or at 1-month follow-up than at baseline.|baseline, post-intervention, 1-month follow-up|||log(seconds)||Standard Error|Mean
635403|NCT02633215|Secondary|Change in Action Arm Research Test (ARAT)|Score at post-intervention minus baseline, score at 1-month follow-up minus baseline. The possible scores range from 0 to 57, with higher scores indicating better performance.|baseline, post-intervention, 1-month follow-up|||units on a scale||Standard Error|Mean
635404|NCT02633215|Primary|Change in Fugl Meyer Assessment Motor Score|Score after intervention minus baseline score, score at 1-month follow-up minus baseline score. The possible scores range from 0 to 66, with 66 indicating the best performance.|baseline, post-intervention, 1-month follow-up|||units on a scale||Standard Error|Mean
635405|NCT02632812|Secondary|Number of Adverse Events||60 days|||adverse events|||Number
635406|NCT02632812|Primary|Prostaglandin Level (PGE2 Quantification)|Tissue prostaglandin concentration quantified by enzyme-linked immunosorbent assay (ELISA) using Cayman Chemical Monoclonal Prostaglandin E2 EIA Kit (item number 514010)|8 days|||pg/mL (mean tissue PGE2 concentration)||95% Confidence Interval|Mean
635407|NCT02632812|Primary|Presence of H. Pylori by Biopsy|Giemsa stain was used to diagnose H. pylori (positive = presence of H. pylori)|8 days|||participants|||Number
635408|NCT02632812|Primary|Intragastric pH||8 days|Intragastric PH measurement was not performed and for this reason it will not be available.|||||
635409|NCT02632812|Primary|Histopathological Score|"Histopathologic grade score developed for microscopic injury evaluation 0 = Normal gastric mucosa or mild chronic inflammation
= Chronic gastritis without activity
= Chronic gastritis with activity on antrum
= Chronic gastritis with activity on the body
= Chronic gastritis with activity on antrum and on the body"|8 days|||Histopathologic grade score||Full Range|Median
635410|NCT02632812|Primary|Endoscopic Score - Modified Lanza Score|"Modified Lanza score according to gastroduodenal mucosal injury:
0 = No hemorrhage or erosion observed
= One or two hemorrhages or erosions observed in one gastric area
= Three to five hemorrhages or erosions observed in one gastric area
= Hemorrhages or erosions observed in two gastric areas, six or more hemorrhages or erosions observed in one gastric area, with the total number not exceeding ten in the entire stomach
= Hemorrhages or erosions observed in three or more gastric areas; eleven or more hemorrhages or erosions observed widely in the entire stomach
= Ulcer"|8 days|||Modified Lanza score||Full Range|Median
635411|NCT02632812|Primary|Endoscopic Score - Cryer Score|"Cryer score according to gastroduodenal mucosal injury:
0 = Normal or erythema
= Any amount of submucosal hemorrhage or edema without erosions
= 1 erosion +- submucosal hemorrhage or edema
= 2-4 erosions +- submucosal hemorrhage or edema
= 5 or more erosions and/or a single ulcer +- submucosal hemorrhage or edema
= Multiple ulcers +- submucosal hemorrhage or edema - Ulcer"|8 days|All recruited volunteers completed the trial.||Cryer score||Full Range|Median
635412|NCT02630563|Secondary|Plasma Concentration of Mycophenolic Acid and Its Metabolite Mycophenolic Acid Glucuronide at Each Time Point|Mycophenolic Acid Glucuronide (MPAG) is an active metabolite of Mycophenolic Acid (MPA).|Pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 4.0, 8.0, and 12.0 hours post oral dosing for participants greater than (>) 24 months, and at pre-dose, 0.75, 2.0, 4.0 and 12.0 hours post oral dosing for participants less than (<) 24 months|The PK population included all randomized and replaced participants adherent to the PK section of the protocol.||mcg/mL||Standard Deviation|Mean
635413|NCT02630563|Primary|Area Under the Plasma Concentration-Time Curve From 0 to 12 Hours of Mycophenolic Acid Normalized for Dose And for Body Surface Area|The area under the plasma concentration-time curve from time zero to twelve hours (AUC [0-12h]) is area under the plasma concentration-time curve from time zero through 12 hours. AUC (0-12) hours was computed using the linear trapezoidal rule. For the calculations of AUC (0-12h), concentrations below the limit of quantification were assigned a value of zero if they occurred at the beginning of a profile. When such values appeared at the end of a profile they were assigned as missing data. AUC0-12h was normalized to 600 milligram per square meter (mg/m^2) and 1.5 gram. AUC was reported in microgram hour per milliliter (mcg*h/mL).|Pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 4.0, 8.0, and 12.0 hours post oral dosing for participants greater than (>) 24 months, and at pre-dose, 0.75, 2.0, 4.0 and 12.0 hours post oral dosing for participants less than (<) 24 months|The pharmacokinetic (PK) population included all randomized and replaced participants adherent to the PK section of the protocol.||mcg*h/mL||Standard Deviation|Mean
635414|NCT02630563|Secondary|Number of Participants With Adverse Events and Serious Adverse Events|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event.|Up to Day 32|The safety population included all participants who were enrolled in the trial||participants|||Number
636590|NCT02540850|Primary|Ct Value (Ct Values From PCR Reaction)|the number of PCR cycles where the amplification signal starts to be observed|1 year|||Ct||95% Confidence Interval|Mean
635416|NCT02630563|Secondary|Maximum Plasma Concentration for Mycophenolic Acid and Mycophenolic Acid Glucuronide|The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration. Cmax was obtained directly from the measured plasma concentration-time curves.|Pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 4.0, 8.0, and 12.0 hours post oral dosing for participants > 24 months, and at pre-dose, 0.75, 2.0, 4.0 and 12.0 hours post oral dosing for participants < 24 months|The PK population was used for the analysis.||mcg/mL||Standard Deviation|Mean
635417|NCT02630563|Secondary|Area Under the Plasma Concentration Time Curve From 0-12 Hours for Mycophenolic Acid and Mycophenolic Acid Glucuronide Phenolic Glucuronide of Mycophenolic Acid|The area under the plasma concentration-time curve from time zero to twelve hours (AUC [0-12h]) is area under the plasma concentration-time curve from time zero through 12 hours. AUC (0-12) hours was computed using the linear trapezoidal rule. For the calculations of AUC (0-12h), concentrations below the limit of quantification were assigned a value of zero if they occurred at the beginning of a profile. When such values appeared at the end of a profile they were assigned as missing data. AUC was reported in microgram hour per milliliter (mcg*h/mL).|Pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 4.0, 8.0, and 12.0 hours post oral dosing for participants greater than (>) 24 months, and at pre-dose, 0.75, 2.0, 4.0 and 12.0 hours post oral dosing for participants less than (<) 24 months|The PK population included all randomized and replaced participants adherent to the PK section of the protocol||mcg*h/mL||Standard Deviation|Mean
635418|NCT02629354|Secondary|AUC0-INF of Ibuprofen|This outcome measure presents the area under the plasma concentration of ibuprofen versus time curve, with extrapolation to infinity (AUC0-INF).|Within 2 hours prior to dosing and at 5, 10,15, 30 and 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose|PK population||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
635419|NCT02629354|Secondary|AUC0-INF of R-ibuprofen|This outcome measure presents the area under the plasma concentration of R-ibuprofen versus time curve, with extrapolation to infinity (AUC0-INF).|Within 2 hours prior to dosing and at 5, 10,15, 30 and 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose|PK population||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
635420|NCT02629354|Primary|AUC0-t of Ibuprofen|This outcome measure presents the area under the plasma concentration of ibuprofen versus time curve, from time zero to t, where t is the time of the last quantifiable concentration (AUC0-t).|Within 2 hours prior to dosing and at 5, 10,15, 30 and 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose|PK population||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
635421|NCT02629354|Primary|AUC0-t of R-ibuprofen|This outcome measure presents the area under the plasma concentration of R-ibuprofen versus time curve, from time zero to t, where t is the time of the last quantifiable concentration (AUC0-t).|Within 2 hours prior to dosing and at 5, 10,15, 30 and 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose|PK population||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
635422|NCT02629354|Secondary|Area Under the Plasma Concentration of S-ibuprofen Versus Time Curve, With Extrapolation to Infinity (AUC0-INF)|This outcome measure presents the area under the plasma concentration of S-ibuprofen versus time curve, with extrapolation to infinity (AUC0-INF).|Within 2 hours prior to dosing and at 5, 10,15, 30 and 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose|PK population||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
635423|NCT02629354|Primary|Area Under the Plasma Concentration of S-ibuprofen Versus Time Curve, From Time Zero to t (AUC0-t)|This outcome measure presents the area under the plasma concentration of S-ibuprofen versus time curve, from time zero to t, where t is the time of the last quantifiable concentration (AUC0-t).|Within 2 hours prior to dosing and at 5, 10,15, 30 and 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose|PK population||hour (h)*ng/mL||Geometric Coefficient of Variation|Geometric Mean
635424|NCT02629354|Primary|Cmax of Ibuprofen|This outcome measure presents the Cmax of ibuprofen in plasma obtained directly from the concentration-time data.|Within 2 hours prior to dosing and at 5, 10,15, 30 and 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose|PK population||ng/mL||Geometric Coefficient of Variation|Geometric Mean
635425|NCT02629354|Primary|Cmax of R-ibuprofen|This outcome measure presents the Cmax of R-ibuprofen in plasma obtained directly from the concentration-time data.|Within 2 hours prior to dosing and at 5, 10,15, 30 and 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose|PK population||ng/mL||Geometric Coefficient of Variation|Geometric Mean
635426|NCT02629354|Primary|Maximum Observed Plasma Concentration (Cmax) of S-ibuprofen|This outcome measure presents the maximum observed concentration (Cmax) of S-ibuprofen in plasma obtained directly from the concentration-time data.|Within 2 hours prior to dosing and at 5, 10,15, 30 and 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose|Pharmacokinetic (PK) population: all subjects who completed the PK sampling in both periods and with no major protocol deviations considered to impact on the analysis of the PK data were included.||nanogram (ng)/ millilitre (mL)||Geometric Coefficient of Variation|Geometric Mean
635427|NCT02628938|Secondary|Self-assessment of Mouth Odor After 7 Days of Use|"Participants were asked to score their own halitosis on a continuous 10-cm visual analogue scale that is marked as no odor on the 0-cm end, and as extremely foul odor on the 10-cm end"|After 7 days of first use|||units on a scale||Standard Deviation|Mean
635428|NCT02628938|Secondary|Volatile Sulfur Compound Scores After the First Use of the Prescribed Method by 15 Minutes (Masking Effect), and After 7 Days of Use (Therapeutic Effect)|Scores using breath checker device (Tanita FitScan HC-212SF Breath Checker) were recorded (0=no odor, 1=slight odor, 2=moderate odor, 3=heavy odor, 4=strong odor, 5=intense odor).|After the first use of the prescribed method by 15 minutes, and after 7 days of use|||units on a scale||Standard Deviation|Mean
635440|NCT02628236|Secondary|OOZING/VESICULATION/CRUSTING|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|24 hours after PDT|||Participants|||Count of Participants
636610|NCT02540434|Secondary|Incidence of Zero Transfusions|Number of patients who receive no allogeneic blood transfusions following study product administration and first 24 hours after procedure end.|24 hours||||||
635429|NCT02628938|Primary|Organoleptic Scores After the First Use of the Prescribed Method by 15 Minutes (Masking Effect), and After 7 Days of Use (Therapeutic Effect).|"The Organoleptic scores were obtained by a calibrated judge who first tested her ability to detect and distinguish odors even at low concentrations using the Smell Identification Test (Sensonics Inc., Haddon Heights, NJ, USA).
To obtain the score, the patient was asked to close her mouth for approximately 3 minutes while breathing only from the nose. Then he/she was asked to release air from the mouth slowly. The judge kept a distance of about 10 cm between her nose and the patient's mouth to determine the score based on the intensity of the odor.
The intensity ratings of 0 to 5 score was used where Score 0 stands for No odor present, score 1 stands barely noticeable odor, score 2 stands slight but clearly noticeable odor, score 3 stands moderate odor, score 4 stands strong offensive odor and a Score 5 stands extremely foul odor."|After the first use of the prescribed method by 15 minutes, and after 7 days of use|||units on a scale||Standard Deviation|Mean
635430|NCT02628418|Secondary|The Costs Involved in Using Gloreha in the Rehabilitation|Costs were calculated in terms of the time required by healthcare personnel, using the average cost per hour of a physiotherapist per total number of rehabilitation treatments per patient. The equivalent cost of the device for the period of patient treatment was calculated incorporating depreciation, considering the estimated residual value of the device with depreciation rate of 20%.. Indirect costs were not considered because these were common to both groups.|Through study completion, from admission to discharge in the Rehabilitation Centre, over a period of about 6 weeks.|||Euros/patient|||Number
635431|NCT02628418|Secondary|Efficacy in Improving Arm Function Abilities Measured by the Change From Baseline in Quick-DASH Questionnaire at End of Inpatient Rehabilitation.|"The Arm disability was assessed of the study with the Quick version of the Disabilities of the Arm, Shoulder, and Hand (Quick-DASH) questionnaire.
The Quick-DASH is a 19-item ordinal scale with a 5-level rating of items from 1 (no difficulty) to 5 (unable to do).
Quick-Dash can be divided into an 11-item (abilities and symptoms) and an 8-item optional work module and sports/performing arts module. In the 11-item sub-scale, the subject defines the ability to perform some actions (8 items) and the intensity of some symptoms (3 items), referring to the previous week. The total score range is from 19 (no disability) to 95 (full disability)."|Baseline and end of the study after 30 sessions, an average of 6 weeks|||units on a scale||95% Confidence Interval|Mean
635432|NCT02628418|Secondary|Efficacy in Improving Arm Function Abilities Measured by the Change From Baseline in Pinch Test at End of Inpatient Rehabilitation.|The Pinch test is a measure of hand strength. Each patient, at baseline and at the end of the study, repeated the test 3 times and the mean value was normalized for body mass index (BMI).|Baseline and end of the study after 30 sessions, an average of 6 weeks|||kg / (kg / m ^ 2||95% Confidence Interval|Mean
635433|NCT02628418|Secondary|Efficacy in Improving Arm Function Abilities Measured by the Change From Baseline in Grip Test at End of Inpatient Rehabilitation.|The Grip test is a measure of hand strength. Each patient, at baseline and at the end of the study, repeated the test 3 times and the mean value was normalized for body mass index (BMI).|Baseline and end of the study after 30 sessions, an average of 6 weeks|||kg / (kg / m ^ 2)||95% Confidence Interval|Mean
635434|NCT02628418|Secondary|The Feasibility of This New Neuromotor Rehabilitation Device (Gloreha)|The feasibility of the device was assessed in terms of the level of operator difficulty for the physiotherapist in managing the device, assessed by visual analogue scale (VAS) (0 extremely simple - 10 extremely difficult). This outcome was measured only in the Gloreha Group in which patients were treated with device.|Baseline and end of the study after 30 sessions, an average of 6 weeks|||units on a scale||Standard Deviation|Mean
635435|NCT02628418|Primary|Efficacy in Improving Arm Function Abilities Measured by the Change From Baseline in Nine Hole Peg Test at End of Inpatient Rehabilitation.|Nine Hole Peg Test (NHPT), a measure of coordination and mono-manual dexterity. It consists in collecting 9 pegs and inserting them into holes in a wooden base within a 50-sec time limit. The score is the average number of pegs inserted/tests performed.|Baseline and end of the study after 30 sessions, an average of 6 weeks|||pegs/sec||95% Confidence Interval|Mean
635436|NCT02628418|Primary|Efficacy in Improving Arm Function Abilities Measured by the Change From Baseline in Motricity Index at End of Inpatient Rehabilitation|"Motricity Index, a measure of the motor function of the paretic upper limb. Motricity Index used to measure the ability to activate a muscle group to move a body segment through a range of motion and resist external force. The upper extremity motricity index includes: 1. pinch grasp, 2. elbow flexion, and 3. shoulder abduction.
The total upper extremity score involved adding one to the sum of the three actions.
The score of each action ranges from 0 (no ability) to 33 (maximal ability) with a maximum possible score=100."|Baseline and end of the study after 30 sessions, an average of 6 weeks|||units on a scale||95% Confidence Interval|Mean
635437|NCT02628418|Primary|Side Effects Using Gloreha Device|The feasibility of the device was assessed in terms of side effects (the physiotherapist was required to report any adverse events occurring during the study in regard to the use of Gloreha);|Through study completion. The specific hand intervention consisted of a total of 30 sessions, lasting 40 min/day, for 5 days/week , from admission to discharge in the Rehabilitation Centre, over a period of about 6 weeks.|||side effects|||Number
635438|NCT02628418|Primary|Number of Patients Who Completed the Hand Rehabilitation Program||Through study completion. The specific hand interventionn consisted of a total of 30 sessions, lasting 40 min/day, for 5 days/week , from admission to discharge in the Rehabilitation Centre, over a period of about 6 weeks.|||participants|||Number
635439|NCT02628236|Secondary|OOZING/VESICULATION/CRUSTING|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|Week 4|||Participants|||Count of Participants
635457|NCT02628236|Secondary|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Baseline|||Participants|||Count of Participants
635441|NCT02628236|Secondary|OOZING/VESICULATION/CRUSTING|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|Baseline|||Participants|||Count of Participants
635442|NCT02628236|Secondary|Scaling and Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Week 4|||Participants|||Count of Participants
635443|NCT02628236|Secondary|Scaling and Dryness at Visit 4|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|24 hours after PDT|||Participants|||Count of Participants
635444|NCT02628236|Secondary|Scaling and Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Baseline|||Participants|||Count of Participants
635445|NCT02628236|Secondary|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|Week 4|||Participants|||Count of Participants
635446|NCT02628236|Secondary|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|24 hours after PDT|||Participants|||Count of Participants
635447|NCT02628236|Secondary|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|5 Minutes after photodynamic therapy|||Participants|||Count of Participants
635448|NCT02628236|Secondary|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|Intraprocedure|||Participants|||Count of Participants
635449|NCT02628236|Secondary|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|Baseline|||Participants|||Count of Participants
635450|NCT02628236|Secondary|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Week 4|||Participants|||Count of Participants
635451|NCT02628236|Secondary|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|24 hours after PDT|||Participants|||Count of Participants
635452|NCT02628236|Secondary|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|5 Minutes after PDT|||Participants|||Count of Participants
635453|NCT02628236|Secondary|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Baseline|||Participants|||Count of Participants
635454|NCT02628236|Secondary|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Week 4|||Participants|||Count of Participants
635455|NCT02628236|Secondary|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|24 hours after PDT|||Participants|||Count of Participants
635456|NCT02628236|Secondary|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|5 Minutes after PDT|||Participants|||Count of Participants
635458|NCT02628236|Secondary|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|Week 4|||Participants|||Count of Participants
635459|NCT02628236|Secondary|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|24 hours after PDT|||Participants|||Count of Participants
635460|NCT02628236|Secondary|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|Baseline|||Participants|||Count of Participants
635461|NCT02628236|Secondary|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Week 4|||Participants|||Count of Participants
635462|NCT02628236|Secondary|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|24 hours after PDT|||Participants|||Count of Participants
635463|NCT02628236|Secondary|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Baseline|||Participants|||Count of Participants
635464|NCT02628236|Primary|AUCt/AUCBL for PpIX|The ratio of AUCt to AUCBL for PpIX|0, 15, 30 minutes, and 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours post-dose|||ratio||95% Confidence Interval|Geometric Mean
635465|NCT02628236|Primary|AUCt for PpIX|The area under the observed plasma concentration time-curve from time 0 to the last quantifiable plasma concentration.|0, 15, 30 minutes, and 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours post-dose|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
635466|NCT02628236|Primary|AUCBL for PpIX|The area under the concentration time-curve assuming the baseline observed plasma concentration existed from time 0 to tlast.|0, 15, 30 minutes, and 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours post-dose|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
635467|NCT02628236|Primary|Time at Which Cmax is Attained (Tmax) for PpIX|Time of the maximum baseline corrected plasma concentration for PpIX measured at at 15 and 30 minutes, 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours following study medication application.If a maximum value occurred at more than one timepoint Tmax is defined as the first timepoint with this value.|2 days|One subject had tmax that could not be determined.||hours||Full Range|Median
635468|NCT02628236|Primary|Maximum Baseline Corrected Plasma Concentration (Cmax) for PpIX|Maximum baseline corrected plasma concentration (Cmax) for PpIX over the 48 hour sampling time period. Blood samples were taken before ALA application and at 15 and 30 minutes, 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours following study medication application.|2 days|For 50% of the subjects, more than 50% of the PpIX plasma concentrations following topical application of ALA HCI were less than the predose plasma concentration. Therefore, negative values were set to 0 to evaluate median baseline corrected plasma concentration.||ng/mL||Full Range|Median
635469|NCT02628236|Primary|The Terminal Exponential Half-life (T1/2,z) for ALA|The terminal slope was calculated by linear least squares regression of the log plasma concentration-time data. The terminal exponential half-life (T1/2,z) will be calculated as 0.693 divided by the absolute value of slope.|2 days|T1/2,z could not be determined in 11 subjects||hours||Geometric Coefficient of Variation|Geometric Mean
635470|NCT02628236|Primary|AUCt|AUCt is the area under the baseline corrected plasma concentration-time profile up to the last quantifiable/non-negative plasma concentration|0, 15, 30 minutes, and 1, 2, 4, 8, 12, 16, 24 hours post-dose|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
635471|NCT02628236|Primary|Time at Which Cmax is Attained (Tmax) for ALA|Time of the maximum baseline corrected plasma concentration for ALA measured at at 15 and 30 minutes, 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours following study medication application.If a maximum value occurred at more than one timepoint Tmax is defined as the first timepoint with this value.|2 days|||hours||Full Range|Median
635472|NCT02628236|Primary|Maximum Baseline Corrected Plasma Concentration (Cmax) for ALA|Maximum baseline corrected plasma concentration (Cmax) for ALA over the 24 hour sampling time period. Blood samples were taken before ALA application and at 15 and 30 minutes, 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours following study medication application.|2 days|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
635473|NCT02628106|Primary|the Change of Tissue Content of Deoxyhemoglobin Assessed by BOLD-MRI|the R2* value at the time after 14days of lipo-PGE1 intravenously minus the value at the baseline，R2* is a measure of the tissue content of deoxyhemoglobin. Which is inversely proportional to oxygen content in tissue|baseline and after 14days of lipo-PGE1 intravenously|A random sample, west China hospital, in accord with a standard 21 people,age > 18 years||1/ms||Standard Deviation|Mean
635474|NCT02627144|Primary|Cumulative Dose of Immunotherapy (Interferon Alpha-2a) in Daily Routine||Up to 52 weeks|FAS. Data were not analyzed for this outcome measure as therapy doses and pattern were not recorded numerically.|||||
639964|NCT02368314|Secondary|Frequency of Venous Thromboembolism Death||During the treatment period (14 days) and follow-up period (till 60-th day)||||||
635476|NCT02627144|Primary|Progression-free Survival (PFS) Time|PFS time is defined as time between start of therapy and progression or death. Kaplan-Meier estimate was used for evaluation. PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions.|Baseline until progression or intolerable toxicity or death, whichever occurred first, assessed up to 6 years|FAS||months||95% Confidence Interval|Median
635477|NCT02627144|Primary|Percentage of Participants With Disease Control|Disease control was defined as having achieved CR, PR, and/or SD during the course of the observation. CR: disappearance of all target lesions and all pathological lymph nodes below 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions.|Baseline until progression or intolerable toxicity, whichever occurred first, assessed up to 6 years|FAS. ‘Number of participants analyzed’ indicate participants who were evaluable for this measure.||percentage of participants|||Number
635478|NCT02627144|Primary|Percentage of Participants With Best Overall Tumor Response|Tumor response was assessed as one of the following: Complete response (CR): disappearance of all target lesions and all pathological lymph nodes below 10 millimeter (mm). Partial response (PR): At least a 30 percent (%) decrease in the sum of diameters of target lesions. Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions.|Baseline until progression or intolerable toxicity, whichever occurred first, assessed up to 6 years|Full analysis set (FAS) included all participants who received at least one dose of study medication and have at least one post dose efficacy assessment, following the intention-to-treat principle. 'Number of participants analyzed' indicate participants with non-missing tumor response data.||percentage of participants|||Number
635479|NCT02627001|Primary|Received Minute Volume (Liters) as Measured by Wright Respirometer|An Impact 731 Ventilator will be attached to a mask. Subjects will hold a mask seal on a cadaver for 100 seconds. The Impact 731 Ventilator will then deliver standardized tidal volumes of 750 cc (delivered tidal volume) 10 times at six second intervals. A Wright respirometer will then measure received tidal volume for each of these 10 breaths.|1 Minute|||Liters||Inter-Quartile Range|Median
635480|NCT02625844|Primary|Average Observed Health Care Personnel Time for Anemia Management With Erythropoiesis Stimulating Agents (ESAs)|Health care personnel time (hours/year) includes preparation, distribution and administration of Erythropoiesis Stimulating Agents (ESAs)|Up to 3 months|||hours/year|||Number
635481|NCT02625298|Secondary|Presence of Clinical Symptoms|Clinical examination will be used to assess the presence of spontaneous or provoked pain, discomfort during chewing, numbness or tenderness to percussion and/or palpation, altered tooth mobility, tooth crown discoloration or abscess and/or sinus tract.|baseline|||participants|||Number
635482|NCT02625298|Primary|Changes Between Initial and Post Treatment Dimensions of Periapical Lesions|Changes in the dimensions of periapical lesions will be performed according to the analysis of initial and post treatment radiographs (baseline, 3, 6, 12, and 24-months subsequent to obturation) after being photographed using a digital camera Kodak EasyShare Max (Z990) with millimetre measurer in order to obtain interpretation of sizes of periapical lesions during conversion of pixels in mm2 by digital data processing in Adobe Photoshop CS software. Sucessful radiographic assessment will include decrease in size of the periapical lesion at the recall time of 24 months.|baseline, 3, 6, 12 and 24 months|||square millimeters|tooth|Standard Deviation|Mean
635483|NCT02625233|Primary|Visual Acuity (logMAR)|The visual acuity (LogMAR) was collected at the initial visit, 4 month, 5 month and 6 month follow-up evaluations. This study is a continuation of a previous study therefore data from the initial visit was included in reporting. The average Visual Acuity (logMAR) across the 4 study visits and at each individual visit was reported for each lens.|Up to 6 Month Follow-up|Subjects that completed all study visits.||LogMAR|Subject Eyes|Standard Deviation|Mean
635484|NCT02625233|Primary|Proportion of Eyes Grade 3 or Higher SLF|Slit lamp findings were graded using a FDA Grade Scale, 0 = None, 1 = Slight, 2 = Moderate, 3 = Significant, 4 = Advanced. Measurements were taken in each subject eye at the initial visit, 4 month, 5 month and 6 month follow-up evaluations. This study is a continuation of a previous study therefore data from the initial visit was included in reporting. The proportion of subject eyes with SLF grade 3 or higher was reported for each lens.|Up to 6 Month Follow-up|Subjects that were dispensed a study lens.||Proporiton of Subject Eyes|Subject Eyes||Number
635485|NCT02625220|Primary|Proportion of Subject Eyes With Acceptable Lens Fit|Acceptability of contact lens fit was assessed via slit lamp and was reported as a binary response as Acceptable or Unacceptable. The proportion of eyes with acceptable fit was reported.|15 Minute Post Insertion|The analysis population consists of subjects that completed all study visits without a major protocol deviation (per-protocol). One subject was excluded from the analysis population due to a major protocol deviation.||proportion of Subject Eyes|Subject Eyes||Number
635486|NCT02625220|Primary|Proportion of Subjects Eyes With Lens Stability With Blink Within 5 Degrees|Lens stability with blink was measured using a slit lamp. The rotational stability of the lens during a series of normal (unforced) blinks was measured for both eyes. The data was dichotomized as ‘response=1’ if the lens stability was less than or equal to 5 degrees or ‘response=0’ otherwise. The proportion of eyes with rotational stability of 5 degrees or lower was reported.|15 Minutes Post Insertion|The analysis population consists of subjects that completed all study visits without a major protocol deviation (per-protocol). One subject was excluded from the analysis population due to a major protocol deviation.||proportion of Subject Eyes|Subject Eyes||Number
635487|NCT02625220|Primary|The Proportion of Eyes With Absolute Rotation Less Than or Equal to 10 Degrees|Absolute rotation was measured using a slit lamp. Absolute rotation measured at 15-minute post insertion was categorized into a binary outcome as ‘response=1’ if the absolute rotation is less than or equal to 10 degrees or ‘response=0’ otherwise. The proportion of eyes with absolute rotation less than or equal to 10 degrees was reported.|15 Minutes Post Insertion|The analysis population consists of subjects that completed all study visits without a major protocol deviation (per-protocol). One subject was excluded from the analysis population due to a major protocol deviation.||proportion of Subject Eyes|Subject Eyes||Number
635488|NCT02625220|Primary|Proportion of Eyes With Monocular Visual Acuity Better Than 20/40|Monocular visual acuity was assessed using distance Snellen visual acuity. Visual Acuity data was dichotomized such that 'response=1' if a subjects has 20/40 or better and 'response=0' if subject has worse than 20/40. The proportion of eyes with 20/40 or better was reported.|7 day follow-up|The analysis population consists of subjects that completed all study visits without a major protocol deviation (per-protocol). One subject was excluded from the analysis population due to a major protocol deviation.||proportion of Subject Eyes|Subject Eyes||Number
635489|NCT02625207|Secondary|Part 2: Number of Participants With Laboratory Abnormalities|Criteria: Hemoglobin; hematocrit; red blood cell count: <0.8*LLN, mean corpuscular volume; mean corpuscular hemoglobin concentration; mean platelet volume: <0.9*LLN or >1.1*ULN, platelet: <0.5*LLN or >1.75*ULN, white blood cells <0.6*LLN or >1.5*ULN, lymphocyte; neutrophil: <0.8*LLN or >1.2*ULN, basophil; eosinophil; monocyte: >1.2*ULN, bilirubin (total, direct, indirect) >1.5*ULN, aspartate aminotransferase; alanine aminotransferase; alkaline phosphatase: >3.0*ULN, total protein; albumin: <0.8*LLN or >1.2*ULN; creatinine: >1.3*ULN, uric acid >1.2*ULN, sodium<0.95*LLN or >1.05*ULN, potassium; chloride; calcium; bicarbonate:<0.9*LLN or >1.1*ULN, glucose <0.6*LLN or >1.5*ULN, urine specific gravity <1.003, urine pH <4.5 or >8, urine glucose or ketones (qualitative) >=1, urine protein; urine blood/hemoglobin >=1, urobilinogen; bilirubin; nitrite; leukocyte esterase >=1.|Baseline up to Day 11|Safety analysis set included all participants who received at least 1 dose of study drug. Data for Part 2 was planned to be analyzed only in Cohorts 1 and 3, as pre specified in protocol.||participants|||Number
635490|NCT02625207|Secondary|Part 1: Number of Participants With Laboratory Abnormalities|Criteria: Hemoglobin; hematocrit; red blood cell count: <0.8*lower limit of normal, (LLN), mean corpuscular volume; mean corpuscular hemoglobin concentration; mean platelet volume:<0.9*LLN or >1.1* upper limit of normal (ULN), platelet: <0.5*LLN or >1.75*ULN, white blood cells <0.6*LLN or >1.5*ULN, lymphocyte; neutrophil: <0.8*LLN or >1.2*ULN, basophil; eosinophil; monocyte:>1.2*ULN, bilirubin (total, direct, indirect) >1.5*ULN, aspartate aminotransferase; alanine aminotransferase; alkaline phosphatase:>3.0*ULN, total protein; albumin:<0.8*LLN or >1.2*ULN; creatinine: >1.3*ULN, uric acid>1.2*ULN, sodium<0.95*LLN or >1.05*ULN, potassium; chloride; calcium; bicarbonate:<0.9*LLN or >1.1*ULN, glucose <0.6*LLN or >1.5*ULN, urine specific gravity <1.003, urine pH <4.5 or >8, urine glucose or ketones (qualitative) >=1, urine protein; urine blood/hemoglobin >=1, urobilinogen; bilirubin; nitrite; leukocyte esterase >=1.|Baseline up to Day 6|Safety analysis set included all participants who received at least 1 dose of study drug.||participants|||Number
635491|NCT02625207|Secondary|Part 2: Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities|Criteria for ECG abnormalities: Maximum PR interval of >=300 msec, maximum QRS interval >=140 msec, maximum QTCF interval (Fridericia’s correction) of 450 to <480 msec, 480 to <500 msec and >=500 msec, maximum increase of >=25 percent for baseline values of >200 msec and >=50 percent for baseline values of <=200 msec for PR interval, maximum increase from baseline of >=50 percent for QRS interval, maximum increase from baseline of >=30 msec to <60 msec and maximum increase from baseline of >60 msec in QTCF interval (Fridericia’s Correction).|Baseline up to Day 11|Safety analysis set included all participants who received at least 1 dose of study drug. Data for Part 2 was planned to be analyzed only in Cohorts 1 and 3, as pre specified in protocol.||participants|||Number
635492|NCT02625207|Secondary|Part 1: Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities|Criteria for ECG abnormalities: Maximum PR interval of >=300 milliseconds (msec), maximum QRS interval >=140 msec, maximum QTCF interval (Fridericia’s correction) of 450 to <480 msec, 480 to <500 msec and >=500 msec, maximum increase of >=25 percent for baseline values of >200 msec and >=50 percent for baseline values of less than or equal to (<=) 200 msec for PR interval, maximum increase from baseline of >=50 percent for QRS interval, maximum increase from baseline of >=30 msec to <60 msec and maximum increase from baseline of >60 msec in QTCF interval (Fridericia’s Correction).|Baseline up to Day 6|Safety analysis set included all participants who received at least 1 dose of study drug.||participants|||Number
635493|NCT02625207|Secondary|Part 2: Number of Participants With Clinically Significant Vital Sign Abnormalities|Criteria for clinically significant vital sign abnormalities included supine/sitting pulse rate of <40 bpm or >120 bpm, standing pulse rate of <40 bpm or >140 bpm, supine SBP and standing SBP of <90 mm Hg, >=30 mm Hg, supine DBP and standing DBP of <50 mm Hg, >=20 mm Hg.|Baseline up to Day 11|Safety analysis set included all participants who received at least 1 dose of study drug. Data for Part 2 was planned to be analyzed only in Cohorts 1 and 3, as pre specified in protocol.||participants|||Number
635494|NCT02625207|Secondary|Part 1: Number of Participants With Clinically Significant Vital Sign Abnormalities|Criteria for clinically significant vital sign abnormalities included supine/sitting pulse rate of less than (<) 40 beats per minute (bpm) or greater than (>)120 bpm, standing pulse rate of <40 bpm or >140 bpm, supine systolic blood pressure (SBP) and standing SBP of <90 millimeter of mercury (mm Hg), greater than or equal to (>=) 30 mm Hg, supine diastolic blood pressure (DBP) and standing DBP of <50 mm Hg, >=20 mm Hg.|Baseline up to Day 6|Safety analysis set included all participants who received at least 1 dose of study drug.||participants|||Number
635495|NCT02625207|Secondary|Part 2: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 11 days that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to end of study (up to 11 days)|Safety analysis set included all participants who received at least 1 dose of study drug. Data for Part 2 was planned to be analyzed only in Cohorts 1 and 3, as pre specified in protocol.||participants|||Number
635510|NCT02625207|Primary|Part 1: Metabolite to Parent Ratio for Area Under the Concentration-Time Curve From Time 0 to 12 Hours for Maraviroc and Its Metabolites (MRAUC12)|MRAUC12 is the ratio of AUC12 of maraviroc to AUC12 of maraviroc's metabolites. Metabolites of Maraviroc included PF-6857639, PF-6857640, PF-06927572 and PF-06927573. AUC12 is the area under the plasma concentration-time profile from time 0 to 12 hours post-dose.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 9, 12 hours post-dose on Day 5|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of primary interest.||ratio||Geometric Coefficient of Variation|Geometric Mean
635496|NCT02625207|Secondary|Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 6 days that were absent before treatment or that worsened relative to pre-treatment state.|Baseline up to end of study (up to 6 days)|Safety analysis set included all participants who received at least 1 dose of study drug.||participants|||Number
635497|NCT02625207|Secondary|Part 1: Plasma Concentration of Metabolites of Maraviroc at 12 Hour Post-dose|Metabolites of maraviroc included PF-6857639, PF-6857640, PF-06927572 and PF-06927573.|12 hour post-dose on Day 5|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of primary interest.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
635498|NCT02625207|Secondary|Part 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Metabolites of Maraviroc|Metabolites of maraviroc included PF-6857639, PF-6857640, PF-06927572 and PF-06927573.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 9, 12 hours post-dose on Day 5|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of primary interest.||hour||Full Range|Median
635499|NCT02625207|Secondary|Part 1: Maximum Observed Plasma Concentration (Cmax) of Metabolites of Maraviroc|Metabolites of maraviroc included PF-6857639, PF-6857640, PF-06927572 and PF-06927573.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 9, 12 hours post-dose on Day 5|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of primary interest.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
635500|NCT02625207|Secondary|Part 1: Average Plasma Concentration (Cav) of Metabolites of Maraviroc|Cavg is the average plasma concentration of metabolites of maraviroc during the 0 to 12 hour time period. It was calculated as area under the plasma concentration-time curve from 0 to 12 hours (AUC [0-12]) divided by 12. Metabolites of maraviroc included PF-6857639, PF-6857640, PF-06927572 and PF-06927573.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 9, 12 hours post-dose on Day 5|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of primary interest.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
635501|NCT02625207|Secondary|Part 1: Area Under The Plasma Concentration-Time Curve From Time 0 to 12 Hours (AUC [0-12]) of Metabolites of Maraviroc|AUC (0-12) is the area under the plasma concentration versus time curve from time zero (pre-dose) to 12 hours post-dose. Metabolites of maraviroc included PF-6857639, PF-6857640, PF-06927572 and PF-06927573.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 9, 12 hours post-dose on Day 5|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of primary interest.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
635502|NCT02625207|Secondary|Part 2: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Maraviroc||Pre-dose, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours post-dose on Day 10|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of primary interest. Data for Part 2 was planned to be analyzed only in Cohorts 1 and 3, as pre specified in protocol.||hour||Full Range|Median
635503|NCT02625207|Secondary|Part 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Maraviroc||Pre-dose, 0.5, 1, 2, 3, 4, 6, 9, 12 hours post-dose on Day 5|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of primary interest.||hour||Full Range|Median
635504|NCT02625207|Secondary|Part 2: Plasma Concentration of Maraviroc at 24 Hours Post-dose||24 hours post-dose on Day 10|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of primary interest. Data for Part 2 was planned to be analyzed only in Cohorts 1 and 3, as pre specified in protocol.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
635505|NCT02625207|Secondary|Part 1: Plasma Concentration of Maraviroc at 12 Hours Post-dose||12 hours post-dose on Day 5|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of primary interest.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
635506|NCT02625207|Secondary|Part 2: Maximum Observed Plasma Concentration (Cmax) of Maraviroc||Pre-dose, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours post-dose on Day 10|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of primary interest. Data for Part 2 was planned to be analyzed only in Cohorts 1 and 3, as pre specified in protocol.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
635507|NCT02625207|Secondary|Part 1: Maximum Observed Plasma Concentration (Cmax) of Maraviroc||Pre-dose, 0.5, 1, 2, 3, 4, 6, 9, 12 hours post-dose on Day 5|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of primary interest.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
635508|NCT02625207|Secondary|Part 2: Average Plasma Concentration (Cavg) of Maraviroc|Cavg is the average plasma concentration of maraviroc during the 0 to 24 hour time period. It was calculated as area under the plasma concentration-time curve from 0 to 24 hours (AUC [0-24]) divided by 24.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours post-dose on Day 10|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of primary interest. Data for Part 2 was planned to be analyzed only in Cohorts 1 and 3, as pre specified in protocol.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
635509|NCT02625207|Secondary|Part 1: Average Plasma Concentration (Cavg) of Maraviroc|Cavg is the average plasma concentration of maraviroc during the 0 to 12 hour time period. It was calculated as area under the plasma concentration-time curve from 0 to 12 hours (AUC [0-12]) divided by 12.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 9, 12 hours post-dose on Day 5|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of primary interest.||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
635511|NCT02625207|Primary|Part 2: Area Under The Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC [0-24]) of Maraviroc|AUC (0-24) is the area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours post-dose on Day 10|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of primary interest. Data for Part 2 was planned to be analyzed only in Cohorts 1 and 3, as pre specified in protocol.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
635512|NCT02625207|Primary|Part 1: Area Under The Plasma Concentration-Time Curve From Time 0 to 12 Hours (AUC [0-12]) of Maraviroc|AUC (0-12) is the area under the plasma concentration versus time curve from time zero (pre-dose) to 12 hours post-dose.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 9, 12 hours post-dose on Day 5|Pharmacokinetic (PK) parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of primary interest.||nanogram*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
635513|NCT02624791|Secondary|Operational Composite Score|Z-score composite of operational testing outcomes|1 day laboratory study|||Z score||Standard Deviation|Mean
635514|NCT02624791|Primary|Tactical Composite Score|Z-score composite of tactical testing outcomes|1 day laboratory study|||Z score||Standard Deviation|Mean
635515|NCT02622568|Primary|Size of Verrucae (Warts)|Diameter of verrucae (warts) at week 12|12 weeks|Only participants completing study are included in analysis.||millimeters||Standard Deviation|Mean
635516|NCT02621034|Primary|Comparison of Post-operative Pain Between the Three Groups at the 72-hour Interval||72 hours|||units on a scale||Standard Deviation|Mean
635517|NCT02621034|Primary|Comparison of Post-operative Pain in the Reciproc and Oneshape Groups Through Out the Intervals||72 hours|||units on a scale||Standard Deviation|Mean
635518|NCT02621034|Primary|Post-operative Pain on the Visual Anlogue Scale (VAS) at the 6-hour Post-operative Interval|The pain VAS is a continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually 10 centimeters (100 mm) in length, For pain intensity, the scale is most commonly anchored by “no pain” (score of 0) and “pain as bad as it could be” or “worst imaginable pain” (score of 10).|6 hours|||units on a scale||Standard Deviation|Mean
635519|NCT02619812|Primary|Stool Consistency|"The subjects rated their stool consistency using the Bristol Stool Scale. The Bristol Stool Scale is a medical aid designed to classify the form of human feces into seven categories or types. Types 1 and 2 indicate constipation with 3 and 4 being the ideal stools especially the latter, as they are the easiest to defecate, and 5-7 tending towards diarrhea."|30 days|Data were not collected.|||||
635520|NCT02619812|Primary|Stool Frequency|Stool frequency was self reported in a daily bowel pattern diary for 30 days.|30 days|Data were not collected.|||||
635521|NCT02619799|Secondary|Perioperative Side Effects|through out the intraoperative period and initial 12 hours postoperatively parturients were assessed for PONV,sedation,respiratory depression hypotension ,bradycardia and shivering.|through out the intraoperative period and first 12 postoperative hours.|||participants|||Number
635522|NCT02619799|Secondary|Duration of Motor Blockade|assessed with modified bromage scale.|every 5 minute intervals for initial 30 min , then every 30 minute intervals for first 6-8 hrs after completion of surgery.|||time in minutes||Standard Deviation|Mean
635523|NCT02619799|Secondary|Onset of Motor Blockade|assessed with modified bromage scale.|every 5 minute intervals for initial 30 min , then every 30 minute intervals for first 6-8 hrs after completion of surgery.|||time in minutes||Standard Deviation|Mean
635524|NCT02619799|Secondary|Duration of Sensory Blockade|the duration of sensory blockade was assessed with pinprick .|every 2- 3 minutes for initial 20 minutes ,then every 30 min intervals for first 6 -8 hrs after completion of surgery..|||time in minutes||Standard Deviation|Mean
635525|NCT02619799|Secondary|Onset of Sensory Blockade|the onset time of sensory blockade was assessed with pinprick .|every 2- 3 minutes for initial 20 minutes ,then every 30 min intervals for first 6 -8 hrs after completion of surgery..|||time in minutes||Standard Deviation|Mean
635526|NCT02619799|Primary|Duration of Postoperative Analgesia|pain is assessed using visual analogue scale every hour after completion of surgery until first 12 postoperative hours.|first 12 hours after completion of surgery.|||time in minutes||Standard Deviation|Mean
635527|NCT02619591|Primary|Pneumothorax (Positive or Negative)|The presence of a pneumothorax at the time of the ultrasound|up to 20 minutes|||participants|||Number
635528|NCT02618772|Other Pre-specified|Guardian/Parent's Prediction is Respect to Intervention Drug|This is a measure how how many times the parent/guardian was correct in predicting whether the patient received intranasal saline or intranasal midazolam as the intervention drug.|Day 1: parent asked immediately after procedure complete|||Times correct|||Number
635529|NCT02618772|Other Pre-specified|Physician's Prediction is Respect to Intervention Drug|This is a measure how how many times the physician was correct in predicting whether the patient received intranasal saline or intranasal midazolam as the intervention drug.|Day 1: physician asked immediately after procedure finished|||Times correct|||Number
635530|NCT02618772|Other Pre-specified|Length of Procedure (Mins)|This is a measure of the length of the procedure (suturing) in minutes.|Day 1|||minutes||Standard Deviation|Mean
635531|NCT02618772|Other Pre-specified|Time That the Participant Remained in Hospital After Procedure (Mins)|Length of stay in the emergency department, measured from the end of the procedure to the time of discharge.|Day 1: at discharge from emergency department (i.e. same day)|||minutes||Standard Deviation|Mean
635532|NCT02618772|Secondary|Per-Protocol: Faces Pain Scale-Revised/ FLACC Scale|"Faces Pain Scale: Validated self-report tool of pain for participants less than 5 years old. It is a scale that allows one to score the sensation of pain from zero to ten. The scale shows a visuals (faces) for each levels 0, 2, 4, 6, 8 and 10 of the scale. For example, 0 is represented by a face visual that expresses no hurt.
FLACC Scale: Tool to assess pain in children unable to use Faces Pain Scale-revised. The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess individuals that are unable to communicate their pain. The scale is scored in a range of 0–10 (0 represents no pain)."|Day 1: immediately after intervention|This is for the per-protocol analysis and thus, includes all participants who fulfill the protocol in the terms of eligibility, all interventions, and outcome assessment.||units on a scale||Standard Deviation|Mean
635550|NCT02617784|Secondary|CL/F of Metabolite Oseltamivir Carboxylate in CAPD Participants|Plasma samples up to 48 hours post-dose during the first (Days 1 to 6) and second (Days 36 to 43) dose analyses were used to calculate apparent clearance adjusted for oral bioavailability. The CL/F with each dose was averaged among all participants and expressed in L/h.|Blood samples 0, 1, 2, 4, 8, 12, 24, 48 hours from D1 and D36 dose|PK Analysis Population.||L/h||Standard Deviation|Mean
635533|NCT02618772|Secondary|Intention to Treat (ITT): Faces Pain Scale-Revised/ FLACC Scale|"Faces Pain Scale: Validated self-report tool of pain for participants less than 5 years old. It is a scale that allows one to score the sensation of pain from zero to ten. The scale shows a visuals (faces) for each levels 0, 2, 4, 6, 8 and 10 of the scale. For example, 0 is represented by a face visual that expresses no hurt.
FLACC Scale: Tool to assess pain in children unable to use Faces Pain Scale-revised. The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess individuals that are unable to communicate their pain. The scale is scored in a range of 0–10 (0 represents no pain)."|Day 1: immediately after intervention|This is for the Intention to Treat analysis and thus, includes all participants that received the study intervention i.e., intranasal saline or intranasal midazolam.||units on a scale||Standard Deviation|Mean
635534|NCT02618772|Secondary|Per-Protocol: Dartmouth Operative Conditions Scale|A tool to measure the effectiveness and safety of pediatric sedation, regardless of technique used for decreasing anxiety or pain during a procedure. The scale asks the physician to rate patient states (pain/stress, movement, consciousness & sedation side effects) based on observed behaviors (each observed behavior is given a score). The scores are then added together to give a score where -3 to 5 where the lower number is indicative of less anxiety/pain.|Day 1: Immediately after suturing (prior to patient discharge from the ER, i.e. same day)|This is for the per-protocol analysis and thus, includes all participants who fulfill the protocol in the terms of eligibility, all interventions, and outcome assessment.||units on a scale||Standard Deviation|Mean
635535|NCT02618772|Secondary|Intention to Treat (ITT): Dartmouth Operative Conditions Scale|A tool to measure the effectiveness and safety of pediatric sedation, regardless of technique used for decreasing anxiety or pain during a procedure. The scale asks the physician to rate patient states (pain/stress, movement, consciousness & sedation side effects) based on observed behaviors (each observed behavior is given a score). The scores are then added together to give a score where -3 to 5 where the lower number is indicative of less anxiety/pain.|Day 1: Immediately after suturing (prior to patient discharge from the ER, i.e. same day)|This is for the Intention to Treat analysis and thus, includes all participants that received the study intervention i.e., intranasal saline or intranasal midazolam.||units on a scale||Standard Deviation|Mean
635536|NCT02618772|Secondary|Per-Protocol: State Trait Anxiety Inventory (STAI)|"Validated measurement of anxiety, to be used to test parental/guardian anxiety at two time points. These time points are before intervention and immediately after suturing (prior to patient discharge from the ER, i.e. same day). The STAI contains 10 items for assessing trait anxiety and 10 for state anxiety. All items are rated on a standard scale (Not at all, Somewhat, Moderately so, Very much so) with a range of 20 to 80 where higher scores indicate greater anxiety and lower scores indicate lower levels of anxiety."|Before intervention and immediately after suturing (prior to patient discharge from the ER, i.e. same day)|This is for the per-protocol analysis and thus, includes all participants who fulfill the protocol in the terms of eligibility, all interventions, and outcome assessment.||units on a scale||Standard Deviation|Mean
635537|NCT02618772|Secondary|Intention to Treat (ITT): State Trait Anxiety Inventory (STAI)|"Validated measurement of anxiety, to be used to test parental/guardian anxiety at two time points. These time points are before intervention and immediately after suturing (prior to patient discharge from the ER, i.e. same day). The STAI contains 10 items for assessing trait anxiety and 10 for state anxiety. All items are rated on a standard scale (Not at all, Somewhat, Moderately so, Very much so) with a range of 20 to 80 where higher scores indicate greater anxiety and lower scores indicate lower levels of anxiety."|Day 1: Before intervention and immediately after suturing (prior to patient discharge from the ER, i.e. same day)|This is for the Intention to Treat analysis and thus, includes all participants that received the study intervention i.e., intranasal saline or intranasal midazolam.||units on a scale||Standard Deviation|Mean
635538|NCT02618772|Secondary|Per-Protocol: Modified Yale Preoperative Anxiety Score (mYPAS)|"Measurement of patient anxiety used to test effect of anxiolytic pre-medication.The mYPAS consists of 5 items (activity, vocalizations, emotional expressivity, state of apparent arousal, and use of parents). Each item has Likert scale whereby participant's behavior is rated from 1 to 4 (Note: Vocalizations is the only item rated from 1 to 6), with higher numbers indicating the highest severity within that item. Each participant was given a mYPAS score for the suturing by two independent raters. These raters watched a digital recording of the participant undergoing suturing and from this digital recording used the mYPAS scale to assign a measurement of the participant's anxiety.
The mYPAS scale is rated as follows: Final scores = (Activity/4 + Vocal/6 + Emotional/4 + Arousal/4 + Parents/4) X 20. Scores range from 23 to 100 where a lower score is indicative of a lower level of anxiety and a higher is indicative of a higher level of anxiety."|Day 1: Baseline, Intervention & Lidocaine|This is for the per-protocol analysis and thus, includes all participants who fulfill the protocol in the terms of eligibility, all interventions, and outcome assessment.||units on a scale||Standard Deviation|Mean
635539|NCT02618772|Secondary|Intention to Treat (ITT): Modified Yale Preoperative Anxiety Score (mYPAS)|"Measurement of patient anxiety used to test effect of anxiolytic pre-medication.The mYPAS consists of 5 items (activity, vocalizations, emotional expressivity, state of apparent arousal, and use of parents). Each item has Likert scale whereby participant's behavior is rated from 1 to 4 (Note: Vocalizations is the only item rated from 1 to 6), with higher numbers indicating the highest severity within that item. Each participant was given a mYPAS score for the suturing by two independent raters. These raters watched a digital recording of the participant undergoing suturing and from this digital recording used the mYPAS scale to assign a measurement of the participant's anxiety.
The mYPAS scale is rated as follows: Final scores = (Activity/4 + Vocal/6 + Emotional/4 + Arousal/4 + Parents/4) X 20. Scores range from 23 to 100 where a lower score is indicative of a lower level of anxiety and a higher is indicative of a higher level of anxiety."|Day 1: During Baseline, Intervention & Lidocaine|This is for the Intention to Treat analysis and thus, includes all participants that received the study intervention i.e., intranasal saline or intranasal midazolam.||units on a scale||Standard Deviation|Mean
635551|NCT02617784|Secondary|CL/F of Oseltamivir in CAPD Participants|Plasma samples up to 12 hours post-dose during the first (Days 1 to 6) and second (Days 36 to 43) dose analyses were used to calculate apparent clearance adjusted for oral bioavailability. The CL/F with each dose was averaged among all participants and expressed in L/h.|Blood samples 0, 1, 2, 4, 8, 12 hours from D1 and D36 dose|PK Analysis Population.||L/h||Standard Deviation|Mean
639819|NCT02371759|Primary|Systolic Blood Pressure at 15 Minutes|Systolic blood pressure values 10 minutes after local anesthesia injection|15th minute|||milimeters of Hg||Standard Deviation|Mean
635540|NCT02618772|Primary|Per-Protocol: Modified Yale Preoperative Anxiety Score (mYPAS)|"Measurement of patient anxiety used to test effect of anxiolytic pre-medication.The mYPAS consists of 5 items (activity, vocalizations, emotional expressivity, state of apparent arousal, and use of parents). Each item has Likert scale whereby participant's behavior is rated from 1 to 4 (Note: Vocalizations is the only item rated from 1 to 6), with higher numbers indicating the highest severity within that item. Each participant was given a mYPAS score for the suturing by two independent raters. These raters watched a digital recording of the participant undergoing suturing and from this digital recording used the mYPAS scale to assign a measurement of the participant's anxiety.
The mYPAS scale is rated as follows: Final scores = (Activity/4 + Vocal/6 + Emotional/4 + Arousal/4 + Parents/4) X 20. Scores range from 23 to 100 where a lower score is indicative of a lower level of anxiety and a higher is indicative of a higher level of anxiety."|Day 1: During suturing|This is for the per-protocol analysis and thus, includes all participants who fulfill the protocol in the terms of eligibility, all interventions, and outcome assessment.||units on a scale||Standard Deviation|Mean
635541|NCT02618772|Primary|Intention to Treat (ITT): Modified Yale Preoperative Anxiety Score (mYPAS)|"Measurement of patient anxiety used to test effect of anxiolytic pre-medication.The mYPAS consists of 5 items (activity, vocalizations, emotional expressivity, state of apparent arousal, and use of parents). Each item has Likert scale whereby participant's behavior is rated from 1 to 4 (Note: Vocalizations is the only item rated from 1 to 6), with higher numbers indicating the highest severity within that item. Each participant was given a mYPAS score for the suturing by two independent raters. These raters watched a digital recording of the participant undergoing suturing and from this digital recording used the mYPAS scale to assign a measurement of the participant's anxiety.
The mYPAS scale is rated as follows: Final scores = (Activity/4 + Vocal/6 + Emotional/4 + Arousal/4 + Parents/4) X 20. Scores range from 23 to 100 where a lower score is indicative of a lower level of anxiety and a higher is indicative of a higher level of anxiety."|Day 1: During suturing|This is for the Intention to Treat analysis and thus, includes all participants that received the study intervention i.e., intranasal saline or intranasal midazolam.||units on a scale||Standard Deviation|Mean
635542|NCT02617888|Primary|Number of Excess Double-strand DNA Break Foci Per Cell in Peripheral Blood Samples Post-imaging|The amount of excess DNA double-strand break foci per cell after cardiac computed tomographic angiography (CCTA) in female patients with and without breast shields, minus the amount of foci prior to CCTA. In addition, changes in DNA double-strand breaks from baseline following cardiac testing in the observational arm is being assessed in an observational manner.|Change from baseline double strand DNA breaks at 30 minutes post-imaging|Female patients 18 years or older who were clinically referred to undergo coronary CT angiography between August 2012 and July 2014 at Walter Reed National Military Medical Center (Bethesda, Maryland) were eligible for enrollment.||gamma-H2AX foci in blood lymphocytes||Standard Deviation|Mean
635543|NCT02617784|Secondary|Percentage of Oseltamivir Dose Eliminated by Dialysis as Metabolite Oseltamivir Carboxylate in CAPD Participants|Dialysate samples up to 48 hours post-dose during the first dose analysis (Days 1 to 6) were used to calculate dialysis elimination, computed as [amount of metabolite in dialysate divided by the oral oseltamivir dose] multiplied by 100. The value was averaged among all participants and expressed as a percent of the oseltamivir dose administered.|Dialysate samples 0 to 48 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).||percentage of oseltamivir dose||Standard Deviation|Mean
635544|NCT02617784|Secondary|Percentage of Oseltamivir Dose Eliminated by Dialysis as Unchanged Drug in CAPD Participants|Dialysate samples up to 48 hours post-dose during the first dose analysis (Days 1 to 6) were used to calculate dialysis elimination, computed as [amount of drug in dialysate divided by the oral oseltamivir dose] multiplied by 100. The value was averaged among all participants and expressed as a percent of the oseltamivir dose administered.|Dialysate samples 0 to 48 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).||percentage of oseltamivir dose||Standard Deviation|Mean
635545|NCT02617784|Secondary|Percentage of Oseltamivir Dose Renally Excreted as Metabolite Oseltamivir Carboxylate in CAPD Participants|Urine samples up to 48 hours post-dose during the first dose analysis (Days 1 to 6) were used to calculate renal excretion, computed as [amount of metabolite in urine divided by the oral oseltamivir dose] multiplied by 100. The value was averaged among all participants and expressed as a percent of the oseltamivir dose administered.|Urine samples 0 to 48 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).||percentage of oseltamivir dose||Standard Deviation|Mean
635546|NCT02617784|Secondary|Percentage of Oseltamivir Dose Renally Excreted as Unchanged Drug in CAPD Participants|Urine samples up to 48 hours post-dose during the first dose analysis (Days 1 to 6) were used to calculate renal excretion, computed as [amount of drug in urine divided by the oral oseltamivir dose] multiplied by 100. The value was averaged among all participants and expressed as a percent of the oseltamivir dose administered.|Urine samples 0 to 48 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).||percentage of oseltamivir dose||Standard Deviation|Mean
635547|NCT02617784|Secondary|CLd of Metabolite Oseltamivir Carboxylate in CAPD Participants|Plasma samples up to 120 hours and dialysate samples up to 48 hours post-dose during the first dose analysis (Days 1 to 6) were used to calculate CLd, computed as [amount of metabolite recovered in dialysate divided by the AUC over the dialysis interval]. The CLd was averaged among all participants and expressed in L/h.|Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 dose; dialysate samples 0 to 48 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).||L/h||Standard Deviation|Mean
635548|NCT02617784|Secondary|CLr of Metabolite Oseltamivir Carboxylate in CAPD Participants|Plasma and urine samples up to 48 hours post-dose during the first dose analysis (Days 1 to 6) were used to calculate CLr, computed as [amount of metabolite excreted divided by the AUC48]. The CLr was averaged among all participants and expressed in L/h.|Blood samples 0, 1, 2, 4, 8, 12, 24, 48 hours from D1 dose; urine samples 0 to 48 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).||L/h||Standard Deviation|Mean
635549|NCT02617784|Secondary|CLr of Oseltamivir in CAPD Participants|Plasma and urine samples up to 12 hours post-dose during the first dose analysis (Days 1 to 6) were used to calculate CLr, computed as [amount of drug excreted divided by the AUC12]. The CLr was averaged among all participants and expressed in L/h.|Blood samples 0, 1, 2, 4, 8, 12 hours from D1 dose; urine samples 0 to 12 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).||L/h||Standard Deviation|Mean
636611|NCT02540434|Secondary|Fibrinogen Repletion|Fibrinogen repletion as measured by ROTEM FIBTEM >10mm after study product administration|Procedure length, the average for participants is approximately 6 hours||||||
635552|NCT02617784|Secondary|Terminal Elimination Half-Life of Metabolite Oseltamivir Carboxylate in CAPD Participants|Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6) and up to 168 hours post-dose during the second dose analysis (Days 36 to 43). Urine and dialysate samples were also obtained up to 48 hours post-dose during the first dose analysis. The time required for the concentration to decrease by one-half was recorded and averaged among all participants and expressed in hours.|Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 and D36 dose AND at 168 hours from D36 dose; urine samples 0 to 48 hours from D1 dose; dialysate samples 0 to 48 hours from D1 dose|PK Analysis Population.||hours||Standard Deviation|Mean
635553|NCT02617784|Secondary|Elimination Rate Constant of Metabolite Oseltamivir Carboxylate in CAPD Participants|Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6) and up to 168 hours post-dose during the second dose analysis (Days 36 to 43). Urine and dialysate samples were also obtained up to 48 hours post-dose during the first dose analysis. The elimination rate constant was calculated as [natural log (ln)(2) divided by the half-life] and expressed as inverse hours (1/h).|Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 and D36 dose AND at 168 hours from D36 dose; urine samples 0 to 48 hours from D1 dose; dialysate samples 0 to 48 hours from D1 dose|PK Analysis Population.||1/h||Standard Deviation|Mean
635554|NCT02617784|Secondary|Tmax of Metabolite Oseltamivir Carboxylate in CAPD Participants|Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6) and up to 168 hours post-dose during the second dose analysis (Days 36 to 43), and the observed time of maximum concentration was recorded. The Tmax following each dose was averaged among all participants and expressed in hours.|Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 and D36 dose AND at 168 hours from D36 dose|PK Analysis Population.||hours||Standard Deviation|Mean
635555|NCT02617784|Secondary|Tmax of Oseltamivir in CAPD Participants|Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6) and up to 168 hours post-dose during the second dose analysis (Days 36 to 43), and the observed time of maximum concentration was recorded. The Tmax following each dose was averaged among all participants and expressed in hours.|Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 and D36 dose AND at 168 hours from D36 dose|PK Analysis Population.||hours||Standard Deviation|Mean
635556|NCT02617784|Secondary|Plasma Concentration of Metabolite Oseltamivir Carboxylate by Timepoint in CAPD Participants|Plasma samples were obtained up to 120 post-dose during the first dose analysis (Days 1 to 6) and up to 168 hours post-dose during the second dose analysis (Days 36 to 43). The concentration at each collection time was recorded and averaged among all participants and expressed in ng/mL.|Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 and D36 dose AND at 168 hours from D36 dose|PK Analysis Population.||ng/mL||Standard Deviation|Mean
635557|NCT02617784|Secondary|Plasma Concentration of Oseltamivir by Timepoint in CAPD Participants|Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6) and up to 168 hours post-dose during the second dose analysis (Days 36 to 43). The concentration at each collection time was recorded and averaged among all participants and expressed in ng/mL.|Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 and D36 dose AND at 168 hours from D36 dose|PK Analysis Population.||ng/mL||Standard Deviation|Mean
635558|NCT02617784|Secondary|Plasma Concentration of Metabolite Oseltamivir Carboxylate in Arterial and Venous Blood by Timepoint in HD Participants|Dialyzer samples were obtained up to 5 hours from the start of dialysis on Days 3 and 40 (corresponding to HD sessions 2 and 18). Arterial concentrations were estimated using the inflow to the dialyzer, and venous concentrations were estimated using the outflow from the dialyzer. The concentration at each collection time was recorded and averaged among all participants and expressed in ng/mL.|Dialyzer samples 1, 2, 4, 5 hours from start of dialysis on Days 3 and 40|PK Analysis Population.||ng/mL||Standard Deviation|Mean
635559|NCT02617784|Secondary|Percentage of Oseltamivir Dose Excreted as Metabolite Oseltamivir Carboxylate in HD Participants|Urine samples up to 42 hours post-dose during the first dose analysis (Days 1 to 5) were used to calculate metabolite excretion, computed as [amount of metabolite excreted divided by the oral oseltamivir dose] multiplied by 100. The value was averaged among all participants and expressed as a percent of the oseltamivir dose administered.|Urine samples 0 to 42 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).||percentage of osteltamivir dose||Standard Deviation|Mean
635560|NCT02617784|Secondary|Percentage of Oseltamivir Dose Excreted as Unchanged Drug in HD Participants|Urine samples up to 42 hours post-dose during the first dose analysis (Days 1 to 5) were used to calculate drug excretion, computed as [amount of drug excreted divided by the oral oseltamivir dose] multiplied by 100. The value was averaged among all participants and expressed as a percent of the oseltamivir dose administered.|Urine samples 0 to 42 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).||percentage of oseltamivir dose||Standard Deviation|Mean
635561|NCT02617784|Secondary|Dialysis Clearance (CLd) of Metabolite Oseltamivir Carboxylate in HD Participants|Plasma samples up to 90 hours post-dose during the first (Days 1 to 5) and second (Days 38 to 43) dose analyses, in addition to dialyzer samples obtained on Days 3 and 40, were used to calculate CLd, computed as [amount of metabolite recovered in dialysate divided by the AUC over the dialysis interval]. The CLd with each dose was averaged among all participants and expressed in L/h.|Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from from D1 and D38 dose; dialyzer samples 1, 2, 4, 5 hours from start of dialysis on Days 3 and 40|PK Analysis Population; n = number of participants included in the specific dose analysis.||L/h||Standard Deviation|Mean
635562|NCT02617784|Secondary|CLr of Metabolite Oseltamivir Carboxylate in HD Participants|Plasma and urine samples up to 42 hours post-dose during the first dose analysis (Days 1 to 5) were used to calculate CLr, computed as [amount of metabolite excreted divided by the AUC42]. The CLr was averaged among all participants and expressed in L/h.|Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42 hours from D1 dose; urine samples 0 to 42 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).||L/h||Standard Deviation|Mean
635563|NCT02617784|Secondary|Renal Clearance (CLr) of Oseltamivir in HD Participants|Plasma and urine samples up to 12 hours post-dose during the first dose analysis (Days 1 to 5) were used to calculate CLr, computed as [amount of drug excreted divided by the AUC12]. The CLr was averaged among all participants and expressed in L/h.|Blood samples 0, 1, 2, 4, 8, 12 hours from D1 dose; urine samples 0 to 12 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).||L/h||Standard Deviation|Mean
639965|NCT02368314|Secondary|Frequency of Symptomatic Nonlethal PATE||During the treatment period (14 days) and follow-up period (till 60-th day)||||||
635564|NCT02617784|Secondary|CL/F of Metabolite Oseltamivir Carboxylate in HD Participants|Plasma samples up to 42 hours post-dose during the first (Days 1 to 5) and second (Days 38 to 43) dose analyses were used to calculate apparent clearance adjusted for oral bioavailability. The CL/F with each dose was averaged among all participants and expressed in L/h.|Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42 hours from D1 and D38 dose|PK Analysis Population; n = number of participants included in the specific dose analysis.||L/h||Standard Deviation|Mean
635565|NCT02617784|Secondary|Oral Plasma Clearance (CL/F) of Oseltamivir in HD Participants|Plasma samples up to 12 hours post-dose during the first (Days 1 to 5) and second (Days 38 to 43) dose analyses were used to calculate apparent clearance adjusted for oral bioavailability. The CL/F with each dose was averaged among all participants and expressed in liters per hour (L/h).|Blood samples 0, 1, 2, 4, 8, 12 hours from D1 and D38 dose|PK Analysis Population; n = number of participants included in the specific dose analysis.||L/h||Standard Deviation|Mean
635566|NCT02617784|Secondary|Tmax of Metabolite Oseltamivir Carboxylate in HD Participants|Plasma samples were obtained up to 90 hours post-dose during the first (Days 1 to 5) and second (Days 38 to 43) dose analyses, and the observed time of maximum concentration was recorded. The Tmax following each dose was averaged among all participants and expressed in hours.|Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D1 and D38 dose|PK Analysis Population; n = number of participants included in the specific dose analysis.||hours||Standard Deviation|Mean
635567|NCT02617784|Secondary|Time to Maximum Plasma Concentration (Tmax) of Oseltamivir in HD Participants|Plasma samples were obtained up to 90 hours post-dose during the first (Days 1 to 5) and second (Days 38 to 43) dose analyses, and the observed time of maximum concentration was recorded. The Tmax following each dose was averaged among all participants and expressed in hours.|Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D1 and D38 dose|PK Analysis Population; n = number of participants included in the specific dose analysis.||hours||Standard Deviation|Mean
635568|NCT02617784|Secondary|Plasma Concentration of Metabolite Oseltamivir Carboxylate by Timepoint in HD Participants|Plasma samples were obtained up to 90 hours post-dose during the first dose analysis (Days 1 to 5) and up to 114 hours post-dose during the second dose analysis (Days 38 to 43). The concentration at each collection time was recorded and averaged among all participants and expressed in ng/mL.|Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49 hours from D1 and D38 dose AND at 90 hours from D1 dose AND at 114 hours from D38 dose|PK Analysis Population; n = number of participants included at specified timepoints in the analysis.||ng/mL||Standard Deviation|Mean
635569|NCT02617784|Secondary|Plasma Concentration of Oseltamivir by Timepoint in HD Participants|Plasma samples were obtained up to 90 hours post-dose during the first dose analysis (Days 1 to 5) and up to 114 hours post-dose during the second dose analysis (Days 38 to 43). The concentration at each collection time was recorded and averaged among all participants and expressed in ng/mL.|Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49 hours from D1 and D38 dose AND at 90 hours from D1 dose AND at 114 hours from D38 dose|PK Analysis Population; number (n) equals (=) number of participants included at specified timepoints in the analysis.||ng/mL||Standard Deviation|Mean
635570|NCT02617784|Primary|AUC of Metabolite Oseltamivir Carboxylate in CAPD Participants During Days 36 to 43|Plasma samples were obtained up to 168 hours post-dose during the second dose analysis (Days 36 to 43), and the AUC48 and AUClast were determined. Values were averaged among all participants and expressed in ng*h/mL.|Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168 hours from D36 dose|PK Analysis Population (Second Dose Subpopulation).||ng*h/mL||Standard Deviation|Mean
635571|NCT02617784|Primary|AUC of Metabolite Oseltamivir Carboxylate in CAPD Participants During Days 1 to 6|Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6), and the AUC was determined from 0 to 48 hours (AUC48) and up to the last measurable concentration (AUClast). Values were averaged among all participants and expressed in ng*h/mL.|Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).||ng*h/mL||Standard Deviation|Mean
635572|NCT02617784|Primary|AUC of Oseltamivir in CAPD Participants During Days 36 to 43|Plasma samples were obtained up to 168 hours post-dose during the second dose analysis (Days 36 to 43), and the AUC12 and AUClast were determined. Values were averaged among all participants and expressed in ng*h/mL.|Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168 hours from D36 dose|PK Analysis Population (Second Dose Subpopulation).||ng*h/mL||Standard Deviation|Mean
635573|NCT02617784|Primary|AUC of Oseltamivir in CAPD Participants During Days 1 to 6|Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6), and the AUC12 and AUClast were determined. Values were averaged among all participants and expressed in ng*h/mL.|Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).||ng*h/mL||Standard Deviation|Mean
635574|NCT02617784|Primary|Cmax of Metabolite Oseltamivir Carboxylate in CAPD Participants During Days 36 to 43|Plasma samples were obtained up to 168 hours post-dose during the second dose analysis (Days 36 to 43), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in ng/mL.|Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168 hours from D36 dose|PK Analysis Population (Second Dose Subpopulation).||ng/mL||Standard Deviation|Mean
635575|NCT02617784|Primary|Cmax of Metabolite Oseltamivir Carboxylate in CAPD Participants During Days 1 to 6|Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in ng/mL.|Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).||ng/mL||Standard Deviation|Mean
635576|NCT02617784|Primary|Cmax of Oseltamivir in CAPD Participants During Days 36 to 43|Plasma samples were obtained up to 168 hours post-dose during the second dose analysis (Days 36 to 43), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in ng/mL.|Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168 hours from Day 36 (D36) dose|PK Analysis Population (Second Dose Subpopulation).||ng/mL||Standard Deviation|Mean
635577|NCT02617784|Primary|Cmax of Oseltamivir in CAPD Participants During Days 1 to 6|Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in ng/mL.|Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).||ng/mL||Standard Deviation|Mean
648518|NCT02101008|Secondary|Progression Free Survival||Every 56 days - for up to two years|||days||Standard Deviation|Mean
635578|NCT02617784|Primary|AUC of Metabolite Oseltamivir Carboxylate in HD Participants During Days 38 to 43|Plasma samples were obtained up to 90 hours post-dose during the second dose analysis (Days 38 to 43), and the AUC42 and AUClast were determined. Values were averaged among all participants and expressed in ng*h/mL.|Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D38 dose|PK Analysis Population (Second Dose Subpopulation).||ng*h/mL||Standard Deviation|Mean
635579|NCT02617784|Primary|AUC of Metabolite Oseltamivir Carboxylate in HD Participants During Days 1 to 5|Plasma samples were obtained up to 90 hours post-dose during the first dose analysis (Days 1 to 5), and the AUC was determined from 0 to 42 hours (AUC42) and up to the last measurable concentration (AUClast). Values were averaged among all participants and expressed in ng*h/mL.|Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).||ng*h/mL||Standard Deviation|Mean
635580|NCT02617784|Primary|AUC of Oseltamivir in HD Participants During Days 38 to 43|Plasma samples were obtained up to 90 hours post-dose during the second dose analysis (Days 38 to 43), and the AUC12 and AUClast were determined. Values were averaged among all participants and expressed in ng*h/mL.|Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D38 dose|PK Analysis Population (Second Dose Subpopulation).||ng*h/mL||Standard Deviation|Mean
635581|NCT02617784|Primary|Area Under the Concentration-Time Curve (AUC) of Oseltamivir in HD Participants During Days 1 to 5|Plasma samples were obtained up to 90 hours post-dose during the first dose analysis (Days 1 to 5), and the AUC was determined from 0 to 12 hours (AUC12) and up to the last measurable concentration (AUClast). Values were averaged among all participants and expressed in nanograms by hours per milliliter (ng*h/mL).|Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).||ng*h/mL||Standard Deviation|Mean
635582|NCT02617784|Primary|Cmax of Metabolite Oseltamivir Carboxylate in HD Participants During Days 38 to 43|Plasma samples were obtained up to 90 hours post-dose during the second dose analysis (Days 38 to 43), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in ng/mL.|Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D38 dose|PK Analysis Population (Second Dose Subpopulation).||ng/mL||Standard Deviation|Mean
635583|NCT02617784|Primary|Cmax of Metabolite Oseltamivir Carboxylate in HD Participants During Days 1 to 5|Plasma samples were obtained up to 90 hours post-dose during the first dose analysis (Days 1 to 5), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in ng/mL.|Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).||ng/mL||Standard Deviation|Mean
635584|NCT02617784|Primary|Cmax of Oseltamivir in HD Participants During Days 38 to 43|Plasma samples were obtained up to 90 hours post-dose during the second dose analysis (Days 38 to 43), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in ng/mL.|Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from Day 38 (D38) dose|PK Analysis Population (Second Dose Subpopulation): All participants who completed treatment and provided evaluable data during the second dose assessment period.||ng/mL||Standard Deviation|Mean
635585|NCT02617784|Primary|Maximum Plasma Concentration (Cmax) of Oseltamivir in HD Participants During Days 1 to 5|Plasma samples were obtained up to 90 hours post-dose during the first dose analysis (Days 1 to 5), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in nanograms per milliliter (ng/mL).|Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from Day 1 (D1) dose|Pharmacokinetic (PK) Analysis Population (First Dose Subpopulation): All participants who completed treatment and provided evaluable data during the first dose assessment period.||ng/mL||Standard Deviation|Mean
635586|NCT02616523|Other Pre-specified|Complication|complications such as obstipation in the postoperative period|up to two weeks||||||
635587|NCT02616523|Secondary|Neuropathic Pain (Pain Questionnaire) dn4|Pain questionnaire dn4 will be send to participants after two months of surgery to evaluate the neuropathic pain. There are minimum 0 points and maximum 10 points. If the score is 4 or higher then the pain is likely to be neuropathic pain.|two months after the surgery|||units on a scale||Standard Deviation|Mean
635588|NCT02616523|Secondary|Consumption of Piritramide|consumption of piritramide (mg) in the recovery room|one hour after the operation|||mg||Standard Deviation|Mean
635589|NCT02616523|Primary|Consumption of Fentanyl|consumption of fentanyl (mg) during the procedure|time of the operation|||mg||Standard Deviation|Mean
635590|NCT02615717|Secondary|Beck Anxiety Inventory (BAI)|Self-report measure of 20 symptoms of anxiety Range: 0-60 all items summed Higher score indicates higher severity|within three days|||units on a scale||Standard Deviation|Mean
635591|NCT02615717|Secondary|Patient Health Questionnaire (PHQ-9)|Self-report measure of 9 symptoms related to depression Range: 0-27, all items summed Higher score indicates higher severity|within three days|||units on a scale||Standard Deviation|Mean
635592|NCT02615717|Secondary|PTSD Checklist (PCL-5)|Self-report of PTSD symptom severity Scale range: 0-80 Total score utilized, all items summed. Higher score indicates higher severity.|within three days|||units on a scale||Standard Deviation|Mean
635593|NCT02615717|Primary|Clinician-Administered PTSD Scale (CAPS-5)|Assesses symptoms and severity of Posttraumatic Stress Disorder Range: 0-80; total score utilized. Higher values indicate higher severity Subscales are summed to create a total score; subscales made up of different facets of PTSD.|within three days|||units on a scale||Standard Deviation|Mean
635594|NCT02614924|Secondary|Intubation Time||up to 10 minutes|||seconds||Inter-Quartile Range|Median
635595|NCT02614924|Primary|Total Time Taken to Complete the Procedure of Awake Intubation||up to 20 minutes|||seconds||Inter-Quartile Range|Median
635596|NCT02614586|Secondary|Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)||Part 2: Day 1 of Intervention Period 1 up to Day 21|Part 2 was not initiated because it was not possible to calculate an ICC due to the magnitude of the intrasubject variability in relation to the intersubject variability.|||||
635613|NCT02614222|Secondary|Patient Satisfaction Recorded on Post-op Day 1 Using Questionnaire|Patient satisfaction will be recorded in the hospital or via phone on post-op day 1, on a 10-point scale (10 being most satisfied), using a questionnaire.|Post-op day 1|This data was not collected for 5 (out of 27) participants.||Units on a Scale||Standard Deviation|Mean
635614|NCT02614222|Secondary|Number of Times Needle Needs Repositioning||Immediately following intervention (within 2 hours)|Data for this outcome measure was not collected.|||||
635597|NCT02614586|Primary|Change From Baseline in P50 Ratio S2/S1 at Central (Cz) Electrode Following Administration of TAK-058|Participants were planned to check for P50 gating ratio. Stimulus signal of 90 decibel pulses of 0.1 millisecond (msec) was to be generated and recorded the event-related potential waveforms. 32 pairs of auditory clicks were to be presented every 10 seconds, with a 500 msec interclick interval. S1 is defined as the conditioning P50 wave with the most positive peak between 30 and 90 msec after the conditioning stimulus. S2 is defined as the test P50 wave with the positive peak after the test stimulus that was closest in latency to the conditioning P50. Amplitude is the difference between the positive peak and the preceding negative trough for both waves. The data from the vertex (Cz site) was to be collected and the P50 gating ratio (S2/S1) was to be calculated as the ratio of the test P50 amplitude to the conditioning P50 amplitude.|Part 2: Day 1 pre-dose and at multiple time points (up to 2 hours) post-dose in each period.|Part 2 was not initiated because it was not possible to calculate an ICC due to the magnitude of the intrasubject variability in relation to the intersubject variability.|||||
635598|NCT02614469|Secondary|Safety Assessment: Adverse Events|Number of participants with adverse events after study drug administration|Up to 10 days after first study drug administration at Day 1 of Period 1|||participants|||Number
635599|NCT02614469|Secondary|Safety Assessment (Vital Signs)|Number of participants with clinically significant findings in vital signs by investigator after study drug administration.|Up to 10 days after first study drug administration at Day 1 of Period 1|||participants|||Number
635600|NCT02614469|Primary|Baseline Corrected T1/2: Baseline Corrected Apparent Terminal Half-life|Correction for individual endogenous urate levels was done by subtracting the individual mean endogenous baseline concentration prior to dosing from each post-dose concentration in the profile. The two samples collected at -12 h and 0 h (pre-dose) before the meal were used to measure the mean endogenous baseline concentrations in each dosing period (periods 1 and 2).|-12 to 0 hr pre-dose and 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 hrs post-dose|Baseline Corrected T 1/2 values for 2 subjects were not able to be calculated based on the serum concentration-time curve of these subjects.||hr||Standard Deviation|Mean
635601|NCT02614469|Primary|Baseline Corrected Tmax: Baseline Corrected Time of Maximum Serum Concentration|Correction for individual endogenous urate levels was done by subtracting the individual mean endogenous baseline concentration prior to dosing from each post-dose concentration in the profile. The two samples collected at -12 h and 0 h (pre-dose) before the meal were used to measure the mean endogenous baseline concentrations in each dosing period (periods 1 and 2).|-12 to 0 h pre-dose and 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, and 48 hrs post-dose|||hr||Full Range|Median
635602|NCT02614469|Primary|Baseline Corrected AUC (0-inf): Baseline Corrected Area Under the Serum Concentration-time Curve From Time 0 to Infinity|Correction for individual endogenous urate levels was done by subtracting the individual mean endogenous baseline concentration prior to dosing from each post-dose concentration in the profile. The two samples collected at -12 h and 0 h (pre-dose) before the meal were used to measure the mean endogenous baseline concentrations in each dosing period (periods 1 and 2).|-12 to 0 hr pre-dose and 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, and 48 hrs post-dose|Baseline Corrected AUC (0-inf) values of 2 subjects were not able to be calculated based on the serum concentration-time curve of these subjects.||mg*hr/dL||Standard Deviation|Mean
635603|NCT02614469|Primary|Baseline Corrected AUC (0-t): Baseline Corrected Area Under the Serum Concentration-time Curve From Time 0 to Time t (Time of Last Quantifiable Serum Concentration)|Correction for individual endogenous urate levels was done by subtracting the individual mean endogenous baseline concentration prior to dosing from each post-dose concentration in the profile. The two samples collected at -12 h and 0 h (pre-dose) before the meal were used to measure the mean endogenous baseline concentrations in each dosing period (periods 1 and 2). Negative concentrations were set to zero.|-12 to 0 hr pre-dose and 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 hrs post-dose|||mg*hr/dL||Standard Deviation|Mean
635604|NCT02614469|Primary|Baseline Corrected Cmax: Baseline Corrected Maximum Serum Concentration|Correction for individual endogenous urate levels was done by subtracting the individual mean endogenous baseline concentration prior to dosing from each post-dose concentration in the profile. The two samples collected at -12 h and 0 h (pre-dose) before the meal were used to measure the mean endogenous baseline concentrations in each dosing period (periods 1 and 2). Negative concentrations were set to zero.|-12 to 0 hr pre-dose and 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 hrs post-dose|||mg/dL||Standard Deviation|Mean
635605|NCT02614469|Primary|T1/2: Apparent Terminal Half-life||-12 to 0 pre-dose and 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 hrs post-dose|T 1/2 of 1 subject was not able to be calculated based on the serum concentration-time curve of the subject.||hr||Standard Deviation|Mean
635606|NCT02614469|Primary|Tmax: Time of Maximum Serum Concentration||-12 to 0 hr pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 hrs post-dose|||hr||Full Range|Median
635607|NCT02614469|Primary|AUC (0-inf): Area Under the Serum Concentration-time Curve From Time 0 to Infinity||-12 to 0 hr pre-dose and 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 hrs post-dose|AUC (0-inf) of 1 subject was not able to be calculated based on the serum concentration-time curve of the subject.||mg*hr/dL||Standard Deviation|Mean
635608|NCT02614469|Primary|AUC (0-t): Area Under the Serum Concentration-time Curve From Time 0 to Time t (Time of Last Quantifiable Plasma Concentration)||-12 to 0 hr pre-dose and 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 hrs post-dose|||mg*hr/dL||Standard Deviation|Mean
635609|NCT02614469|Primary|Cmax: Maximum Observed Serum Urate Concentration||-12 to 0 hrs pre-dose and 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hrs post-dose|||mg/dL||Standard Deviation|Mean
635610|NCT02614222|Secondary|Undesired Muscle Weakness Measured Subjectively|Number of participants that report undesired muscle weakness. Undesired muscle weakness will be measured subjectively - whether patient unable to ambulate and/or requiring the use of an immobilizer.|During hospital stay (maximum 3 days)|This data was not collected for 6 (out of 27) participants.||Participants|||Count of Participants
635611|NCT02614222|Secondary|Incidence of Postoperative Nausea and Vomiting|Number of participants that reported postoperative nausea and vomiting|During hospital stay (maximum 3 days)|This data was not collected for 4 (out of 27) participants.||Participants|||Count of Participants
635612|NCT02614222|Secondary|Number of Patients That Needed Rescue Opioids||During hospital stay (maximum 3 days)|This data was not collected for 4 (out of 27) patients||Participants|||Count of Participants
635615|NCT02614222|Secondary|Number of Attempts|Number of instrument pricks before target is reached|Immediately following intervention (within 2 hours)|This data was not collected for 3 (out of 27) participants.||Attempts||Standard Deviation|Mean
635618|NCT02613910|Secondary|Titer of Human Anti-human Antibody|Blood samples for HAHA titer analysis were planned to be collected at Baseline (Week 0) and at Week 12, 24, 36, 48 and at Follow-up visit (Week 60); and at individualized Follow-up visit at Week 72. Due to the termination of this study, analysis of this information was not performed.|Up to Week 72|Safety Population. Due to the termination of this study, 0 participants were analyzed.|||||
635619|NCT02613910|Secondary|Number of Participants With Positive Human Anti-human Antibody (HAHA) Immune Response|Blood samples for HAHA titer analysis were planned to be collected at Baseline (Week 0) and at Week 12, 24, 36, 48 and at Follow-up visit (Week 60); and at individualized Follow-up visit at Week 72. Due to the termination of this study, analysis of this information was not performed.|Up to Week 72|Safety Population. Due to the termination of this study, 0 participants were analyzed.|||||
635620|NCT02613910|Secondary|Cumulative Dose of Corticosteroids|Cumulative dose of corticosteroids was calculated to evaluate steroid exposure and reductions in steroid dose while maintaining disease control. Due to the termination of this study, analysis of this information was not performed.|Up to Week 60|Safety Population. Due to the termination of this study, 0 participants were analyzed.|||||
635621|NCT02613910|Secondary|Number of Days a Participant is Off Steroid Therapy by Week 60|Number of days, a participant did not require steroid therapy was observed and summarized. Due to the termination of this study, analysis of this information was not performed.|Up to Week 60|Safety Population. Due to the termination of this study, 0 participants were analyzed.|||||
635622|NCT02613910|Secondary|Number of Days Minimal Steroid Therapy is Maintained by Week 60|Minimal steroid therapy is an oral prednisone/prednisolone dose of <= 10 mg/day. Due to the termination of this study, analysis of this information was not performed.|Up to Week 60|Safety Population. Due to the termination of this study, 0 participants were analyzed.|||||
635623|NCT02613910|Secondary|Time to Initial Flare/Relapse After Completing the Ofatumumab SC Treatment Course During the Individualized Follow-up Period|It is the time from Baseline to the time of appearance of >=3 new lesions within 1 month that do not heal spontaneously within 1 week, or to the time when there is an extension of lesions that were present at the Baseline visit. Due to the termination of this study, analysis of this information was not performed.|Up to Week 156|Safety Population. Due to the termination of this study, 0 participants were analyzed.|||||
635624|NCT02613910|Secondary|Time to Initial Flare/Relapse After Completing the Ofatumumab SC Treatment Course|It is the time from Baseline to the time of appearance of >=3 new lesions within 1 month that do not heal spontaneously within 1 week, or to the time when there is an extension of lesions that were present at the Baseline visit. Due to the termination of this study, analysis of this information was not performed.|Up to Week 60|Safety Population. Due to the termination of this study, 0 participants were analyzed.|||||
635625|NCT02613910|Secondary|Number of Participants Who do Not Flare/Relapse on Minimal Steroid Therapy|It was planned to assess as participants who achieved remission on minimal steroid therapy and did not subsequently have a flare/relapse of disease by Week 60. Due to the termination of this study, analysis of this information was not performed.|Up to Week 60|Safety Population. Due to the termination of this study, 0 participants were analyzed.|||||
635626|NCT02613910|Secondary|Number of Participants Who do Not Flare/Relapse|It was planned to assess participants with out an appearance of >= 3 new lesions within 1 month that do not heal spontaneously within 1 week, or an extension (worsening) of lesions that were present at the Baseline visit. Due to the termination of this study, analysis of this information was not performed.|Up to Week 60|Safety Population. Due to the termination of this study, 0 participants were analyzed.|||||
635627|NCT02613910|Secondary|Time to Initial Flare/Relapse by Week 60|Time to initial flare/relapse is time from Baseline to the time of appearance of >= 3 new lesions within 1 month that do not heal spontaneously within 1 week, or to the time when there is an extension of lesions that were present at the Baseline visit. The appearance of 1 or 2 new lesions was not to be considered a flare/relapse. Due to the termination of this study, analysis of this information was not performed.|Up to Week 60|Safety Population. Due to the termination of this study, 0 participants were analyzed.|||||
635628|NCT02613910|Secondary|Duration of Remission After Completing the Ofatumumab SC Treatment Course|Duration of remission after completing the ofatumumab SC treatment course was to be assessed during the individualized Follow-up period for participants who were in remission on minimal steroid therapy by Week 60. Due to the termination of this study, analysis of this information was not performed.|Up to Week 156|Safety Population. Due to the termination of this study, 0 participants were analyzed.|||||
635629|NCT02613910|Secondary|Time to Remission on Minimal Steroid Therapy|Time to remission on minimal steroid therapy is the time from Baseline to the time the participant initially tapered his/her oral prednisone/prednisolone dose to <=10 mg/day and maintained <=10 mg/day of oral prednisone/prednisolone with no new or non-healing (established) lesions for >=8 weeks by Week 60. Due to the termination of this study, analysis of this information was not performed.|Up to Week 60|Safety Population. Due to the termination of this study, 0 participants were analyzed.|||||
635630|NCT02613910|Secondary|Number of Participants Achieving Remission on Minimal Steroid Therapy|Remission is defined as absence of new or non-healing (established) lesions for >=8 weeks and minimal steroid therapy is defined as an oral prednisone/prednisolone dose of <=10 mg/day. Due to the termination of this study, analysis of this information was not performed.|Up to Week 60|Safety Population. Due to the termination of this study, 0 participants were analyzed.|||||
635631|NCT02613910|Secondary|Number of Participants Achieving Remission While Off Steroid Therapy by Week 60|Remission is the absence of new or non-healing (established) lesions for >=8 weeks. Due to the termination of this study, analysis of this information was not performed.|Up to Week 60|Safety Population. Due to the termination of this study, 0 participants were analyzed.|||||
635632|NCT02613910|Secondary|Time to Remission Off Steroid Therapy by Week 60|Remission is the absence of new or non-healing (established) lesions for >=8 weeks. Due to the termination of this study, analysis of this information was not performed.|Up to Week 60|Safety Population. Due to the termination of this study, 0 participants were analyzed.|||||
635633|NCT02613910|Secondary|Number of Participants Achieving Sustained Remission on Minimal Steroid Therapy by Week 60|Sustained remission on minimal steroid therapy is the time from Baseline (Week 0) to the time the participant initially tapered his/her oral prednisone/prednisolone dose to <=10 mg/day and maintained <=10 mg/day of oral prednisone/prednisolone with no new or non-healing (established) lesions for >=8 weeks and maintained that status until Week 60. Due to the termination of this study, analysis of this information was not performed.|Up to Week 60|Safety Population. Due to the termination of this study, 0 participants were analyzed.|||||
635634|NCT02613910|Secondary|Duration of Remission on Minimal Steroid Therapy|Duration of remission on minimal steroid therapy is the total time (sum) of all periods of remission while on minimal steroid therapy (oral prednisone/prednisolone dose <=10 mg/day) up to Week 60. Due to the termination of this study, analysis of this information was not performed.|Up to Week 60|Safety Population. Due to the termination of this study, 0 participants were analyzed.|||||
635635|NCT02613910|Secondary|Time to Sustained Remission on Minimal Steroid Therapy|Time to sustained remission on minimal steroid therapy is the time from Baseline (Week 0) to the time the participant initially tapered his/her oral prednisone/prednisolone dose to <=10 mg/day and maintained <=10 mg/day of oral prednisone/prednisolone with no new or non-healing (established) lesions for >= 8 weeks and maintained that status until Week 60. Due to the termination of this study, analysis of this information was not performed.|Up to Week 60|Safety Population. Due to the termination of this study, 0 participants were analyzed.|||||
635636|NCT02613910|Primary|Change From Baseline in Immunoglobulin (Ig) A, IgM, and IgG Levels|Blood samples for IgA, IgM, and IgG analysis were planned to be collected at Baseline (Week 0) and at Week 12, 24, 36, 48 and at Follow-up visit (Week 60); and at individualized Follow-up visits at Week 72, 84, 96, 108, 120, 132, 144 and 156. Baseline was to be considered as the value obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline value from the individual post-randomization values. Due to the termination of this study, analysis of this information was not performed.|Up to Week 156|Safety Population. Due to the termination of this study, 0 participants were analyzed.|||||
635637|NCT02613910|Primary|Number of Participants With Laboratory Results of Potential Clinical Concern|Blood samples were planned to be collected at Baseline (Week 0) and at Week 8, 20, 28, 36, 44, 52 and at Follow-up visit (Week 60); and at individualized Follow-up visits at Week 72, 84, 96, 108, 120, 132, 144 and 156 for evaluation of clinical chemistry parameters; and at Baseline (Week 0) and at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56 and at Follow-up visit (Week 60); and at individualized Follow-up visits at Week 72, 84, 96, 108, 120, 132, 144 and 156 for evaluation of hematology parameters. No laboratory values of potential clinical concern were identified for this one participant.|Up to Week 156|Safety Population.||Participants|||Number
635638|NCT02613910|Primary|Change From Baseline in Specific Gravity of Urine|Urine samples were planned to be collected at Baseline (Week 0) and at Week 8, 20, 28, 36, 44, 52 and at Follow-up visit (Week 60) for evaluation of urine specific gravity. Baseline was to be considered as the measurement obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline from the individual post-randomization measurements. Due to the termination of this study, analysis of this information was not performed.|Up to Week 60|Safety Population. Due to the termination of this study, 0 participants were analyzed.|||||
635639|NCT02613910|Primary|Change From Baseline in Urine Power of Hydrogen (pH) at the Indicated Time Points|Urine samples were plannedto be collected at Baseline (Week 0) and at Week 8, 20, 28, 36, 44, 52 and at Follow-up visit (Week 60) for evaluation of pH. Baseline was to be considered as the measurement obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline from the individual post-randomization measurements. Due to the termination of this study, analysis of this information was not performed.|Up to Week 60|Safety Population. Due to the termination of this study, 0 participants were analyzed.|||||
635640|NCT02613910|Primary|Number of Participants With Change in Urinalysis Results|Urine samples were planned to be collected at Baseline (Week 0) and at Week 8, 20, 28, 36, 44, 52 and at Follow-up visit (Week 60) for evaluation of appearance, protein, glucose, leukocyte esterase, ketones, hemoglobin, microalbumin, creatinine, microalbumin:creatinine ratio and microscopy which included RBC/high powered field, WBC/ hight powered field, epithelial cells, trichomonas, bacteria, yeast, crystals, ammonium urates, mucous threads, amorphous sediment and casts. Baseline was to be considered as the measurement obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline from the individual post-randomization measurements. Due to the termination of this study, analysis of this information was not performed.|Up to Week 60|Safety Population. Due to the termination of this study, 0 participants were analyzed.|||||
635641|NCT02613910|Primary|Change From Baseline in Creatinine Clearance (Calculated) at the Indicated Time Points|Blood samples were plannedto be collected at Baseline (Week 0) and at Week 8, 20, 28, 36, 44, 52 and at Follow-up visit (Week 60); and at individualized Follow-up visits at Week 72, 84, 96, 108, 120, 132, 144 and 156. Baseline was to be considered as the value obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline value from the individual post-randomization values. Due to the termination of this study, analysis of this information was not performed.|Up to Week 156|Safety Population. Due to the termination of this study, 0 participants were analyzed.|||||
635642|NCT02613910|Primary|Change From Baseline in Sodium, Potassium, Chloride, Calcium, Glucose, Bicarbonate and Blood Urea Nitrogen at the Indicated Time Points|Blood samples were planned to be collected at Baseline (Week 0) and at Week 8, 20, 28, 36, 44, 52 and at Follow-up visit (Week 60); and at individualized Follow-up visits at Week 72, 84, 96, 108, 120, 132, 144 and 156. Baseline was to be considered as the value obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline value from the individual post-randomization values. Due to the termination of this study, analysis of this information was not performed.|Up to Week 156|Safety Population. Due to the termination of this study, 0 participants were analyzed.|||||
635643|NCT02613910|Primary|Change From Baseline in Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase and Gamma Glutamyl Transferase at the Indicated Time Points|Blood samples were planned to be collected at Baseline (Week 0) and at Week 8, 20, 28, 36, 44, 52 and at Follow-up visit (Week 60); and at individualized Follow-up visits at Week 72, 84, 96, 108, 120, 132, 144 and 156. Baseline was to be considered as the value obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline value from the individual post-randomization values. Due to the termination of this study, analysis of this information was not performed.|Up to Week 156|Safety Population. Due to the termination of this study, 0 participants were analyzed.|||||
635644|NCT02613910|Primary|Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points|Blood samples were planned to be collected at Baseline (Week 0) and at Week 8, 20, 28, 36, 44, 52 and at Follow-up visit (Week 60); and at individualized Follow-up visits at Week 72, 84, 96, 108, 120, 132, 144 and 156. Baseline was to be considered as the value obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline value from the individual post-randomization values. Due to the termination of this study, analysis of this information was not performed.|Up to Week 156|Safety Population. Due to the termination of this study, 0 participants were analyzed.|||||
635645|NCT02613910|Primary|Change From Baseline in Total Protein and Albumin at the Indicated Time Points|Blood samples were planned to be collected at Baseline (Week 0) and at Week 8, 20, 28, 36, 44, 52 and at Follow-up visit (Week 60); and at individualized Follow-up visits at Week 72, 84, 96, 108, 120, 132, 144 and 156. Baseline was to be considered as the value obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline value from the individual post-randomization values. Due to the termination of this study, analysis of this information was not performed.|Up to Week 156|Safety Population. Due to the termination of this study, 0 participants were analyzed.|||||
635646|NCT02613910|Primary|Change From Baseline in Red Blood Cell (RBC) Count and Nucleated RBCs at the Indicated Time Points|Blood samples were planned to be collected at Baseline (Week 0) and at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56 and at Follow-up visit (Week 60); and at individualized Follow-up visits at Week 72, 84, 96, 108, 120, 132, 144 and 156. Baseline was to be considered as the value obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline value from the individual post-randomization values. Due to the termination of this study, analysis of this information was not performed.|Up to Week 156|Safety Population. Due to the termination of this study, 0 participants were analyzed.|||||
635647|NCT02613910|Primary|Change From Baseline in CD4: CD8 Ratio at the Indicated Time Points|Blood samples were planned to be collected at Baseline (Week 0) and at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56 and at Follow-up visit (Week 60); and at individualized Follow-up visits at Week 72, 84, 96, 108, 120, 132, 144 and 156. Baseline was to be considered as the value obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline value from the individual post-randomization values. Due to the termination of this study, analysis of this information was not performed.|Up to Week 156|Safety Population. Due to the termination of this study, 0 participants were analyzed.|||||
635648|NCT02613910|Primary|Change From Baseline in White Blood Cell (WBC) Count, Neutrophil, Lymphocyte, Basophil, Eosinophil, Monocyte, Platelet Count, Bands, Cluster of Differentiation (CD)19+ B-lymphocyte Counts, CD3, CD4 and CD8 at the Indicated Time Points|Blood samples were planned to be collected at Baseline (Week 0) and at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56 and at Follow-up visit (Week 60); and at individualized Follow-up visits at Week 72, 84, 96, 108, 120, 132, 144 and 156. Baseline was to be considered as the value obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline value from the individual post-randomization values. Due to the termination of this study, analysis of this information was not performed.|Up to Week 156|Safety Population. Due to the termination of this study, 0 participants were analyzed.|||||
635649|NCT02613910|Primary|Change From Baseline in Hematocrit at the Indicated Time Points|Blood samples were planned to be collected at Baseline (Week 0) and at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56 and at Follow-up visit (Week 60); and at individualized Follow-up visits at Week 72, 84, 96, 108, 120, 132, 144 and 156. Baseline was to be considered as the value obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline value from the individual post-randomization values. Due to the termination of this study, analysis of this information was not performed.|Up to Week 156|Safety Population. Due to the termination of this study, 0 participants were analyzed.|||||
635650|NCT02613910|Primary|Change From Baseline in Hemoglobin at the Indicated Time Points|Blood samples were planned to be collected at Baseline (Week 0) and at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56 and at Follow-up visit (Week 60); and at individualized Follow-up visits at Week 72, 84, 96, 108, 120, 132, 144 and 156. Baseline was to be considered as the value obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline value from the individual post-randomization values. Due to the termination of this study, analysis of this information was not performed.|Up to Week 156|Safety Population. Due to the termination of this study, 0 participants were analyzed.|||||
635651|NCT02613910|Primary|Number of Participants With Clinically-significant Electrocardiogram (ECG) Abnormalities|12-lead ECG was planned to be taken on Baseline (Week 0) and at Follow-up visit (Week 60). No clinically significant ECG abnormalities were noted for the one participant.|Up to Week 60|Safety Population||Participants|||Number
635652|NCT02613910|Primary|Number of Participants With Vital Signs of Clinical Concern|Participants with vitals signs of clinical concern were planned to be summarized. No vital signs of clinical concerns were present for the one participant.|Up to Week 60|Safety Population.||Participants|||Number
635653|NCT02613910|Primary|Change From Baseline in Body Temperature at the Indicated Time Points|Body temperature was planned to be taken at pre-dose and 4 hour post-dose on Week 4; pre-dose and 1 hour post-dose from Week 6 to Week 56; and at Follow-up visit (Week 60). Baseline was to be considered as the measurement obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline value from the individual post-randomization values. Due to termination of study, analysis of this information was not performed.|Baseline (Week 0) and up to Week 60|Safety Population.|||||
635654|NCT02613910|Primary|Change From Baseline in Heart Rate at the Indicated Time Points|Heart rate was to be taken at pre-dose and 4 hour post-dose on Week 4; pre-dose and 1 hour post-dose from Week 6 to Week 56; and at Follow-up visit (Week 60). Measurements were to be obtained in the sitting position and at the time of the blood pressure measurement. Baseline was to be considered as the measurement obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline value from the individual post-randomization values. Due to the termination of this study, analysis of this information was not performed|Baseline (Week 0) and up to Week 60|Safety Population.|||||
641030|NCT02322892|Secondary|Length of Stay|Duration of intensive care unit stay|Until hospital discharge, limit 60 days|||days||Inter-Quartile Range|Median
635655|NCT02613910|Primary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points|SBP and DBP were to be taken at pre-dose and 4 hour post-dose on Week 4; pre-dose and 1 hour post-dose from Week 6 to Week 56; and at Follow-up visit (Week 60). Measurements were to be obtained after at least 5 minutes of rest. Baseline was to be considered as the measurement obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline value from the individual post-randomization values. Due to the termination of this study, analysis of this information was not performed.|Baseline (Week 0) and up to Week 60|Safety Population|||||
635656|NCT02613910|Primary|Number of Participants With Injection Site Reactions|Number of participants with injection site reactions were planned to be summarized. No cases of injection site reaction were reported for the one participant.|Up to Week 60|Safety Population||Participants|||Number
635657|NCT02613910|Primary|Number of Participants With Post-injection Systemic Reactions|All serious post-injection systemic reactions were planned to be monitored closely throughout the study and number of participants with post-injection systemic reactions was to be summarized. No cases of post-injection systemic reactions were reported for the one participant.|Up to Week 60|Safety Population||Participants|||Number
635658|NCT02613910|Primary|Number of Participants With Infections|All infections were planned to be monitored closely throughout the study and participants with infections were to be summarized. No cases of infection were reported for the one participant.|Up to Week 60|Safety Population||Participants|||Number
635659|NCT02613910|Primary|Number of Participants Withdrawn Due to Treatment-related AEs|Participants withdrawn due to treatment related AEs were to be summarized. One participant was enrolled into the study and was withdrawn early due to study termination. The participant was not withdrawn due to treatment-related AEs.|Up to Week 60|Safety Population.||Participants|||Number
635660|NCT02613910|Primary|Number of Participants With Serious Adverse Events (SAEs) and AEs of Special Interest (AESI)|Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention, events associated with liver injury and impaired liver function were to be categorized as SAE. AEs of special interest included any opportunistic infections, serious post injection systemic reactions, progressive multifocal leukoencephalopathy (PML), hepatitis B virus infection or reactivation, severe mucocutaneous reactions (e.g., toxic epidermal necrolysis and stevens-johnson syndrome), cytopenias and cardiovascular events. Participants with SAEs and AESI were to be summarized. No serious adverse events (SAEs) or adverse events of special interest (AESI) reported.|Up to Week 156|Safety Population. One participant was enrolled into the study and was withdrawn early due to study termination. No SAEs or AESIs were reported for this participant.||Participants|||Number
635661|NCT02613910|Primary|Number of Participants With Adverse Events Related to Ofatumumab SC|Participants with AEs related to ofatumumab were to be summarized. No adverse events related to ofatumumab were reported for the one participant enrolled.|Up to Week 60|Safety Population. No adverse events related to ofatumumab were reported for the one participant enrolled.||Participants|||Number
635662|NCT02613910|Primary|Number of Participants With Severe Adverse Events|Severity is a category utilized for rating the intensity of an adverse event. Participants with severe AEs were to be summarized. No serious adverse events (SAEs) were reported for the one participant enrolled.|Up to Week 60|Safety Population. No safety events were reported for the one participant enrolled.||Participants|||Number
635663|NCT02613910|Primary|Number of Participants With Adverse Events(AEs) and AEs Leading to Permanent Discontinuation of Ofatumumab SC (AELD)|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants with AEs and those with AEs leading to permanent discontinuation of ofatumumab SC (AELD) were to be summarized. Safety Population consists of all participants enrolled in the study. No safety events were reported for the one participant enrolled.|Up to Week 60|Safety Population. No safety events were reported for the one participant enrolled.||Participants|||Number
635664|NCT02612077|Secondary|Quality of Life - Global Health Status|Participants rated their quality of life (global health status) on the European Organization for Research and Treatment of Cancer 30-item Core Quality of Life Questionnaire (EORTC QLQ C-30), with total scores ranging from 0 (worst) to 100 (best).|Baseline, 6 and 12 months|Participants in the efficacy analysis set who filled out the questionnaire at inclusion||units on a scale||Inter-Quartile Range|Median
635665|NCT02612077|Secondary|Overall Survival|Overall Survival (OS) was defined as the time between the treatment start (date of the first infusion of bevacizumab) and death from any cause. Kaplan Meier estimates of median overall survival were calculated for the metastatic lines of treatment, with a median follow-up of 18, 15 and 13 months, respectively.|Up to 36 months|Efficacy analysis set receiving bevacizumab at inclusion||Months||95% Confidence Interval|Median
635666|NCT02612077|Primary|Progression-free Survival|Kaplan Meier estimates of median progression-free survival according to the metastatic line of treatment, for a median follow-up of 18, 15 and 13 months, respectively|within 36 months|Efficacy analysis set receiving bevacizumab at inclusion||Months||95% Confidence Interval|Median
635667|NCT02612064|Secondary|Change From Baseline in Tactile Threshold Post First Treatment by Direct Application and on Day 3|The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gives two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g.|Baseline, 60 seconds post first treatment, Day 3|Analysis for this outcome was performed on ITT population, defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment.||g||Standard Deviation|Mean
635744|NCT02604589|Primary|Narcotic Use|Quantity of systemic narcotic used (hydromorphone hydrochloride, Dilaudid) averaged per day over the length of hospital stay, in mg/24 hours.|3 days or hospital length of stay, if less than 3 days|One subject withdrawn in Bupivicaine 0.5% (HIGH DOSE) group||mg/24 hours over days 1-3||Standard Deviation|Mean
635668|NCT02612064|Secondary|Change From Baseline in Schiff Sensitivity Score Post First Treatment by Direct Application|The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale which was scored as follows 0: Participant does not respond to air stimulation; 1: Participant responded to air stimulus but does not request discontinuation of stimulus; 2: Participant responded to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus. A reduction in Schiff Sensitivity score was indicative of an improvement in sensitivity.|Baseline to 60 seconds post first treatment|Analysis for this outcome was performed on ITT population, defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment.||score on a scale||Standard Deviation|Mean
635669|NCT02612064|Primary|Change From Baseline in Schiff Sensitivity Score on Day 3|The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale which was scored as follows - 0: Participant does not respond to air stimulation; 1: Participant responded to air stimulus but does not request discontinuation of stimulus; 2: Participant responded to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus. A reduction in Schiff Sensitivity score was indicative of an improvement in sensitivity.|Baseline to 3 days|Analysis for this outcome was performed on ITT population, defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment.||Score on a scale||Standard Deviation|Mean
635670|NCT02611765|Primary|Treatment Success Defined as a Decrease in Rapid Plasma Reagin (RPR) Titer of >= 2 Dilutions (4-fold)|Number of participants who achieve treatment success. Loss to follow-up was assumed to be a failure.|12 months|||participants|||Number
635671|NCT02611154|Secondary|Testosterone Level in Blood as Measured for Safety|Testosterone level in blood to ensure safety levels of testosterone prior to (Day 0) and after the first two weeks of drug administration (Day 19). Steroid levels below the normal range were considered safe to continue study participation.|Day 0 and Day 19|||ng/mL||Full Range|Mean
635672|NCT02611154|Secondary|Number of Participants With Suspicious Steroid Profile in Urine Samples at Baseline|"Participants were asked to provide 3 urine samples at Day 1, Day 3, Day 5 to measure their baseline urinary steroid marker levels. To accommodate participant schedules, all baseline samples were collected within a two week timeframe. This outcome is measuring if any participants baseline urine samples resulted in a suspicious steroid profile. For this study, suspicious is defined as any urine sample resulting in testosterone steroid detection above 200ng/mL."|Day 1, Day 3, Day 5|||Participants|||Count of Participants
635673|NCT02611154|Primary|Steroid Levels in Urine Steroid Profile|"Participants were instructed to follow this dosing pattern:
Begin taking Intranasal Testosterone at Day 1 for 5 consecutive days (Days 1-5), then to take 2 days off (Day 6 and 7) Urine sample at Day 6 Begin taking Intranasal Testosterone at Day 8 for 5 consecutive days (Days 8-12), then to take 3 days off (Day 13, Day 14, Day 15) Urine sample at Day 13 Begin taking Intranasal Testosterone at Day 16 for 5 consecutive days (Days 16-20), then to take 2 days off (Day 21 and 22) Urine sample at Day 21 Begin taking Intranasal Testosterone at Day 23 for 5 consecutive days (Days 23-27 ), then to take 2 days off (Day 28 and 29) Urine sample at Day 28
The first day of the dosing pattern is considered Day 1 and the last day of the pattern is considered Day 29.
Samples 4-8 were analyzed between 0 and 24hours post-dose Sample 9 was analyzed 48 hours post-dose Sample 10 was analyzed 72 hours post-dose Sample 11 was analyzed one week post-dose"|4 weeks of dosing for each participant|||ng/mL||Standard Deviation|Mean
635701|NCT02609841|Secondary|Incidence of Cardiac Arrhythmias|Incidence of serious cardiac arrhythmias in patients during the observational period. Serious arrhythmias defined as ventricular tachycardia or > 5 sec pause.|12 days|Patients who received all 6 hemodialysis treatments and wore Body Guardian Device, a non-invasive wearable remote cardiac rhythm monitoring system||% of patients|||Number
635702|NCT02609841|Secondary|Incidence of Pre-dialysis Hyperkalemia (HK) After the Long Inter-dialytic Period (LIDP) in Patients on ≥3K Dialysate.|Incidence of pre-dialysis hyperkalemia (HK) in patients after the long inter-dialytic period (LIDP) in patients on ≥3K dialysate. Hyperkalemia defined as serum potassium (S-K) >5.0 mEq/L.|12 days|Per protocol population||% of patients|||Number
635703|NCT02609841|Primary|Incidence of Pre-dialysis HK After the LIDP in <3K Dialysate Patients|Incidence of pre-dialysis hyperkalemia (HK) in patients after the long inter-dialytic period (LIDP) in patients on <3K dialysate. Hyperkalemia defined as serum potassium (S-K) >5.0 mEq/L.|12 Days|Per Protocol Population: all enrolled subjects who receive 6 dialysis treatments within the 12-day study period||Percent of participants|||Number
639820|NCT02371759|Primary|Systolic Blood Pressure at 10 Minutes|Systolic blood pressure values 5 minutes after local anesthesia injection|10th minute|||milimeters of Hg||Standard Deviation|Mean
639821|NCT02371759|Primary|Baseline Systolic Blood Pressure||Baseline, 0 minutes|||milimeters of Hg||Standard Deviation|Mean
635719|NCT02609178|Primary|△DT Value|"Disocclusion time (DT) is defined as the time from maximum intercuspation to complete disocclusion during lateral movement. DT related tooth contacts with muscle activity. Abnormities in DT would result in change of muscle activity, thus facilitate the occurrence of temporomandibular joint disorders.
In the study, the DT value of each crown would be assessed before try-in (baseline) and immediately after try-in using T-scan (FGP, AVR, CON). Try-in procedure would be finished by the same clinician.
△DT was calculated for minimizing individual difference among participants. The equation for △DT was: △DT(FGP/ AVR/ CON)= DT (FGP/ AVR/ CON)-DT(baseline)"|2 weeks(plus or minus 7 days) after tooth preparation|Including participants who tried in all of the three differently designed artificial crowns.||seconds||Standard Deviation|Mean
635720|NCT02609178|Secondary|Likert's Scale|"The questionaire was designed to evaluate participants' feeling towards the occlusal interference. It would be given to the subject after immediately try-in the crowns. In the questionaire:
Score 0 = No interference (feel comfortable while biting on the artificial crown) Score 1 = Moderate interference(could feel the artificial crown is higher when biting on the artificial crown, but when firmly clenched, the upper teeth could bite on the lower ones) Score 2 = High interference(the artificial teeth is higher that the upper teeth couldn't bite on all the lower teeth when firmly clenched)"|2 weeks(plus or minus 7 days) after tooth preparation|Including participants who tried in all of the three differently designed artificial crowns.||participants|||Number
635721|NCT02609178|Secondary|Occlusal Adjusting Time for Crowns|Try-in procedure would be finished by the same clinician. The occlusal adjusting time would be counted using a timer and recorded.|2 weeks(plus or minus 7 days) after tooth preparation|Including participants who tried in all of the three differently designed artificial crowns.||minutes||Standard Deviation|Mean
635722|NCT02609178|Primary|△OT Value|"Occlusion time (OT) is defined as the time from the first contact of occluding teeth to maximum intercuspation. OT is directly related with patients’ occlusal contact pattern; and some have considered it as a capable description of occlusion.
In the study, the OT value of each crown would be assessed before try-in (baseline) and immediately after try-in using T-scan (FGP, AVR, CON). Try-in procedure would be finished by the same clinician.
△OT was calculated for minimizing individual difference among participants. The equation for △OT was:△OT(FGP/ AVR/ CON)= OT (FGP/ AVR/ CON)-OT(baseline)"|2 weeks(plus or minus 7 days) after tooth preparation|Including participants who tried in all of the three differently designed artificial crowns.||seconds||Standard Deviation|Mean
635723|NCT02608489|Secondary|Number of Participants Who Stop Using the Eye Drops Due to Drug-related Discomfort|Drug-related discomfort is defined as having started after eye drop instillation and lasting several minutes, occurring every time during instillation at any time up to 12 weeks into the follow-up period. Patients that had any adverse events or wanted to stop using the eye drops were excluded from the study, but these patients were included in the safety evaluation.|12 weeks|Overall, 1 of 31 patients (3.22%), a 64-year-old man who underwent bilateral sequential same-day cataract surgery, stopped using the study eye drops owing to severe irritation in the D group.||participants|||Number
635724|NCT02608489|Secondary|Grades of Anterior Chamber Cells.|"Anterior chamber inflammation was examined with a slit-lamp clinically, and divided into six grades using the Standardization of Uveitis Nomenclature (SUN) working group grading scheme.
grade 0 : <1 cell in field, grade 0.5 : 1-5 cells in field, grade 1 : 6-15 cells in field, grade 2 : 16-25 cells in field grade 3 : 26-50 cells in field, grade 4 : >50 cells in field Field size is a 1 mm X 1 mm slit beam"|12 weeks|||grade|Participants|Standard Deviation|Mean
635725|NCT02608489|Primary|Lissamine Green (LG) Conjunctival Staining That is Related to Dry Eye Severity|"Ocular surface damage was assessed by the National Eye Institute (NEI) workshop grading system, and conjunctival LG staining were evaluated. Instillation of 1% lissamine green in both eyes. After 1 or 2 full blinks, the intensity of staining of both medial and lateral bulbar conjunctiva was cored. According to the National Eye Institute (NEI) workshop grading system, the conjunctiva was divided into six sections. The minimum staining score was 0 and the maximum staining score was 18 points (up to 3 points for each section).
0 : best score (no conjunctival damage) 18 : worst score (severe conjunctival damages)"|12 weeks|||Scores on a scale|Participants|Standard Deviation|Mean
635726|NCT02608489|Primary|Corneal Fluorescein Staining That is Related to Dry Eye Severity.|"Ocular surface damage was assessed by the National Eye Institute (NEI) workshop grading system, and corneal fluorescein staining was evaluated. Instillation of fluorescein in both eyes. After 1 or 2 full blinks, the intensity of staining of both cornea was scored. According to the National Eye Institute (NEI) workshop grading system, the cornea was divided into five sections. The minimum staining score was 0 and the maximum staining score was 15 points (up to 3 points for each section).
0 : best score (no corneal damage) 15 : worst score (severe corneal damages)"|12 weeks|||scores|Participants|Standard Deviation|Mean
635727|NCT02608489|Primary|Tear Break-up Time (TBUT) That is Related to Dry Eye Severity.|TBUT was assessed by instillation of a drop of 2% sterile fluorescein into the conjunctival sac and recording the interval between the last complete blink and the first appearance of a dry spot or disruption of the tear film.|12 weeks|||seconds|Participants|Standard Deviation|Mean
635728|NCT02608489|Primary|Changes in HOAs After Blinking That is Related to Dry Eye Severity.|Corneal HOAs and serial measurement of ocular total HOAs were evaluated using a KR-1W wavefront analyzer (Topcon Medical System, Inc., Tokyo, Japan). Serial measurement of total ocular HOAs was measured every second for 10 s after complete blinking in continuous measurement mode. The difference between the fifth and first HOA was used to evaluate the tear film instability.|12 weeks|||microns|Participants|Standard Deviation|Mean
635729|NCT02608489|Primary|Schirmer I Test Without Anesthesia That is Related to Dry Eye Severity.|Schirmer paper strips were placed into the temporal one third of the lower conjunctival sac for 5 min and the wetness on the strips was measured.|12 weeks|||mm|Participants|Standard Deviation|Mean
635730|NCT02608489|Primary|an Ocular Surface Disease Index (OSDI) Questionnaire That is Related to Dry Eye Severity.|The OSDI questionnaire consists of 12 questions that evaluate subjective symptoms related to dry eye and vision The score ranges were between 0 and 100 scores and the higher scores represent a worse outcome.|12 weeks|||scores on a scale|Participants|Standard Deviation|Mean
635745|NCT02604550|Secondary|"Percent of Patients Rating Their Satisfaction as Excellent or Good"|Patient satisfaction will be reported on a scale of excellent, good, satisfactory, or poor, two weeks following surgery.|2 Weeks Post-Surgery|This analysis includes participants who completed the study and used a smartphone application to record study outcome measures following surgery.||percentage of participants|||Number
635731|NCT02606838|Secondary|Percent of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding the Styx Lancing Device|Staff obtained responses from persons with Diabetes using short questionnaires to provide feedback on instructions for use and the basic operation of the Styx Lancing Device. Subjects could respond 'Strongly Agree' or 'Agree' or are 'Neutral' or 'Disagree' or 'Strongly Disagree'. The percent of subjects who provided responses that were 'Strongly Agree' or 'Agree' or 'Neutral' about each statement was calculated.|1 hour|||percentage of participants|||Number
635732|NCT02606838|Secondary|Number of Subjects With Numeric Meter Results When Users Obtain Alternate Site (AST) Palm Blood Using the Styx Lancing Device ( 30 Gauge Lancets)|Untrained subjects with Diabetes operated the Styx Lancing Device with 30 Gauge lancets to obtain AST palm capillary blood. Study Staff tested the capillary blood using Contour NEXT Blood Glucose Meters (BGMs) and recorded the results. Meter results could be numeric, non-numeric (ie, error messages), or not obtained at all. The number of subjects with numeric BGMS results was determined.|1 hour|117 (119-2) Subject results were analyzed. Two subject results were not evaluable because staff deviated from protocol by interfering with subjects' operation of the device.||participants|||Number
635733|NCT02606838|Secondary|Number of Subjects With Numeric Meter Results When Users Obtain Fingerstick Capillary Blood Using the Styx Lancing Device ( 30 Gauge Lancets)|Untrained subjects with Diabetes operated the Styx Lancing Device with 30 Gauge lancets to obtain fingerstick capillary blood. Study Staff tested the capillary blood using Contour NEXT Blood Glucose Meters (BGMs) and recorded the results. Meter results could be numeric, non-numeric (ie, error messages), or not obtained at all. The number of subjects with numeric BGMS results was determined.|1 hour|||participants|||Number
635734|NCT02606838|Secondary|Number of Subjects With Numeric Meter Results When Users Obtain Alternate Site (AST) Palm Blood Using the Styx Lancing Device ( 28 Gauge Lancets)|Untrained subjects with Diabetes operated the Styx Lancing Device with 28 Gauge lancets to obtain AST palm capillary blood. Study Staff tested the capillary blood using Contour NEXT Blood Glucose Meters (BGMs) and recorded the results. Meter results could be numeric, non-numeric (ie, error messages), or not obtained at all. The number of subjects with numeric BGMS results was determined.|1 hour|118 (119-1) Subject results were analyzed. One subject result was not evaluable because staff deviated from protocol by interfering with subject operation of the device.||participants|||Number
635735|NCT02606838|Primary|Number of Subjects With Numeric Meter Results When Users Obtain Fingerstick Capillary Blood Using the Styx Lancing Device ( 28 Gauge Lancets)|Untrained subjects with Diabetes operated the Styx Lancing Device with 28 Gauge lancets to obtain fingerstick capillary blood. Study Staff tested the capillary blood using Contour NEXT Blood Glucose Meters (BGMs) and recorded the results. Meter results could be numeric, non-numeric (ie, error messages), or not obtained at all. The number of subjects with numeric BGMS results was determined.|1 hour|||participants|||Number
635736|NCT02606734|Primary|Volume (Percentage) of Contrast Media (CM) Diverted (Saved) in a Total Procedure|The subject is exited from the study once they are discharged.|1 Day|||percent of contrast media saved||Standard Deviation|Mean
635737|NCT02605928|Primary|True Positive Detection of Synovial Fluid Marked in Case Report Form|Measurement device indicates with a sound and visual feedback when needle is in contact with synovial fluid. Physician verifies the location with ultrasound imaging, aspiration of synovial fluid and/or lack of resistance in glucocorticoid injection. Even if the device does not detect the synovial fluid, physician performs the injection when needed. Physician marks to the case report form whether the device provided detections during the puncture and were the detections true or false detections.|During intra-articular injection|||percentage of injected joints|Injected joints|95% Confidence Interval|Number
635738|NCT02604589|Secondary|Surgical Intensive Care Unit (SICU) Length of Stay|Integer days of admission to the surgical intensive care unit. For patients not requiring admission to surgical intensive care, patient is not analyzed. Usual range is 3-5 days.|from admission to Surgical Intensive Care unit to discharge from Surgical Intensive Care Unit|Only patients analyzed who had surgical intensive care unit admission.||days||Standard Deviation|Mean
635739|NCT02604589|Secondary|Hospital Length of Stay|Integer days of inpatient admission in the hospital stay that included randomization.|from randomization to discharge, usually within the range of 5-15 days|One subject withdrawn in Bupivicaine 0.5% (HIGH DOSE) group. This leaves only one subject to analyze, so standard deviation =0||days||Standard Deviation|Mean
635740|NCT02604589|Secondary|Mortality|All cause death, death associated with infusion catheter, within 30 days from date of randomization. This outcome will be scored as yes/no and cause of death will be collected.|30 days|One subject withdrawn in Bupivicaine 0.5% (HIGH DOSE) group||Participants|||Count of Participants
635741|NCT02604589|Secondary|Morbidity|Collection of complications observed at any point during the hospital admission that included randomization, including pneumothorax, hemothorax, acute respiratory distress syndrome, pneumonia, empyema, need for tracheostomy, need for mechanical ventilation, length of time on mechanical ventilation, and an assessment of the degree of association of each event with the catheter insertion procedure or with underlying trauma. Each of these outcomes will be scored as yes/no.|3 days or hospital length of stay, whichever is longer|One subject withdrawn in Bupivicaine 0.5% (HIGH DOSE) group||number of complications|||Number
635742|NCT02604589|Secondary|Time to Improvement in Pain Intensity|Determine the impact of catheter-infused medications on self-reported pain intensity reported as a change from baseline (admission) at 24, 48, 72 hours and at 3 days post catheter placement or at discharge (or PCA placement in comparator group) on a 0-10 point Likert scale, with 0=no pain, and 10= the worst pain ever. Response will be defined as time to a decrease of at least two points on the scale.|3 days or hospital length of stay, if less than 3 days|One subject withdrawn in Bupivicaine 0.5% (HIGH DOSE) group. Only one subject remains to be analyzed in that group so standard deviation = 0||days||Standard Deviation|Mean
635743|NCT02604589|Secondary|Time to Improvement in Pulmonary Function|Determine the impact of catheter-infused medications on maximal inspiratory lung volume measured by incentive spirometer (IS) as a change from baseline at 24, 48, 72 hours and at 3 days post catheter placement or at discharge (or PCA placement in comparator group). Endpoint will be the time to improvement of vital capacity to greater than 1.4 liters (or 15 mL/kg).|3 days or hospital length of stay, if less than 3 days|One subject withdrawn in Bupivicaine 0.5% (HIGH DOSE) group. This leaves only one member to analyze; therefore standard deviation = 0.||days||Standard Deviation|Mean
641282|NCT02314546|Primary|Time From Administration to Discharge||Minutes from administration to discharge|||minutes||Standard Deviation|Mean
635746|NCT02604550|Secondary|Time to Straight Less Raise|The amount of time (in hours) it takes for participants to have the ability to perform a straight leg raise post-surgery.|Post-Surgery (up to 6 days)|This analysis includes participants who completed the study and used a smartphone application to record when they were able to perform a straight leg raise following surgery.||hours||Standard Deviation|Mean
635747|NCT02604550|Secondary|Patient-Reported Itching|Total occurrences of patient-reported itching post-surgery.|Post-Surgery (up to 6 days)|This analysis includes participants who completed the study and used a smartphone application for 6 days post-operatively to record every time they experienced itching.||occurrence of itching|||Number
635748|NCT02604550|Secondary|Patient-Reported Sedation|Total occurrences of patient-reported feelings of sedation post-surgery.|Post-Surgery (up to 6 days)|This analysis includes participants who completed the study and used a smartphone application for 6 days post-operatively to record every time they experienced feelings of sedation.||occurrence of sedation|||Number
635749|NCT02604550|Secondary|Patient-Reported Constipation|Total occurrences of patient-reported constipation post-surgery.|Post-Surgery (up to 6 days)|This analysis includes participants completing the study and who used a smartphone application for 6 days post-operatively to record every time they experienced constipation.||occurrence of constipation|||Number
635750|NCT02604550|Secondary|Patient-Reported Vomiting|Total occurrences of patient-reported vomiting post-surgery.|Post-Surgery (up to 6 days)|This analysis includes participants who completed the study and used a smartphone application for 6 days post-operatively to record every time they experienced vomiting.||occurrence of vomiting|||Number
635751|NCT02604550|Secondary|Patient-Reported Nausea|Total occurrences of patient-reported nausea post-surgery.|Post-Surgery (up to 6 days)|This analysis includes participants completing the study who used a smartphone application for 6 days post-operatively to record every time they experienced nausea.||occurrence of nausea|||Number
635752|NCT02604550|Secondary|Total Hours of Sleep|The total hours of sleep first postoperative night, between 0 to 12 hours.|First Postoperative Night (up to 12 hours)|This analysis includes participants who completed the study and used a smartphone application to record their number of hours of sleep during the night following their surgery.||hours||Standard Deviation|Mean
635753|NCT02604550|Secondary|Number of Percocet Tablets Consumed|Participants recorded the total number of Percocet 7.5/325 (acetaminophen and oxycodone) tablets they took every day, in order to assess post-surgical use of opioids between the study arms,|Post surgery, Day 0 to Day 6|This analysis includes participants who completed the study and used a smartphone application to record the number of Percocet tablets taken for 6 days post-surgery.||count of tablets||Standard Deviation|Mean
635754|NCT02604550|Primary|Pain Score|Pain scores range from 0 (no pain at all) to 10 (worst imaginable pain). Pain level was reported at the time of discharge from the surgery recovery room, the evening of the day of surgery, and then three times per day for six days post-surgery. During the six days after surgery, the morning assessment asked about typical knee pain levels overnight, the afternoon assessment asked about knee pain levels since the morning entry, and the evening assessment asked about knee pain levels since the afternoon entry.|Post-surgery (day of surgery to 6 days post-surgery)|This analysis includes participants who completed the study and used a smartphone application to record pain level for 6 days post-surgery.||units on a scale||Standard Deviation|Mean
635755|NCT02604407|Secondary|Clinical Global Impression of Improvement (CGI-I) Score at Visit 6 (Week 4)|CGI scales permit a global evaluation of the participant’s severity and improvement over time. CGI-I was performed to rate the severity of a participant's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).|Visit 6 (Week 4)|Full-analysis set (FAS) consisted of all participants in the safety set who had at least 1 postdose baseline primary efficacy assessment (ADHD-RS with prompt total score) on treatment with number of participants evaluable for this outcome.||Units on a scale||Standard Deviation|Mean
635756|NCT02604407|Primary|Change From Baseline in the Adult Attention-deficit/Hyperactivity Disorder Rating Scale-4 (ADHD-RS) With Prompts Total Score at Visit 6 (Week 4)|The ADHD-RS was developed to measure the behaviors of children with Attention deficit hyperactivity disorder (ADHD). The adult ADHD-RS with prompts consists of 18 items designated to reflect current symptomatology of ADHD based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria. Each item is scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms), with the total score for the rating scale ranging from 0 to 54. Higher score = more severe symptoms.The scale is subdivided into 2 subscales of 9 symptoms each: hyperactivity/impulsivity and inattentiveness. Adult prompts are included with the ADHD-RS to create a semistructured measurement that allows the clinician to probe the extent, frequency, breadth, severity, and consequences of these symptoms to ascertain impairment in an adult population.|Baseline, Visit 6 (Week 4)|Full Analysis Set (FAS) consisted of all participants in the safety set who had at least 1 post dose baseline primary efficacy assessment (ADHD-RS with prompt total score) on treatment.||Units on a scale||Standard Deviation|Mean
635757|NCT02604264|Primary|The Number of Positive Blood Cultures (PBCs) Per 100 Patient-months||Up to 12 months|||PBC per 100-patient months||95% Confidence Interval|Mean
635758|NCT02604017|Secondary|Percentage of Participants With Post-treatment Relapse in Mono-infected HCV GT1, DAA-Naïve Participants|Post-treatment relapse was defined as confirmed HCV RNA ≥LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels <LLOQ at the end of treatment, excluding reinfection.|From the end of treatment through 12 weeks after the last dose of study drug|All participants in the ITT population who were mono-infected HCV GT1, DAA-naïve, received at least 1 dose of study drug, completed treatment, and had HCV RNA <LLOQ at the final treatment visit.||percentage of participants||95% Confidence Interval|Number
635759|NCT02604017|Secondary|Percentage of Participants With Post-treatment Relapse|Post-treatment relapse was defined as confirmed HCV RNA ≥LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels <LLOQ at the end of treatment, excluding reinfection.|From the end of treatment through 12 weeks after the last dose of study drug|All participants who received at least 1 dose of study drug, completed treatment, and had HCV RNA <LLOQ at the final treatment visit.||percentage of participants||95% Confidence Interval|Number
635799|NCT02597543|Secondary|Hospitalization for Cardiac Related Causes|Hospitalization for cardiac related causes after enrollment. Time frame after enrollment (date of cardiac MRI) was 10 months|10 months after enrollment (from date of cardiac MRI)|||Participants|||Count of Participants
635760|NCT02604017|Secondary|Percentage of Participants With On-treatment Virologic Failure in Mono-infected HCV GT1, DAA-Naïve Participants|On-treatment virologic failure was defined as confirmed increase of >1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥100 IU/mL after HCV RNA <LLOQ during treatment, or HCV RNA ≥LLOQ at end of treatment with at least 6 weeks of treatment.|Treatment Weeks 1, 2, 4, 8 (end of treatment for 8-week treatment arm), and 12 (end of treatment for 12-week treatment arm) or premature discontinuation from treatment|All participants in the ITT population who were mono-infected HCV GT1, DAA-naïve.||percentage of participants||95% Confidence Interval|Number
635761|NCT02604017|Secondary|Percentage of Participants With On-treatment Virologic Failure|On-treatment virologic failure was defined as confirmed increase of >1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥100 IU/mL after HCV RNA <LLOQ during treatment, or HCV RNA ≥LLOQ at end of treatment with at least 6 weeks of treatment.|Treatment Weeks 1, 2, 4, 8 (end of treatment for 8-week treatment arm), and 12 (end of treatment for 12-week treatment arm) or premature discontinuation from treatment|All participants who received at least 1 dose of study drug (ITT population).||percentage of particpants||95% Confidence Interval|Number
635762|NCT02604017|Secondary|Percentage of Participants With SVR12 in HCV GT1-infected, Prior Sofosbuvir (SOF) Treatment-Experienced Participants|SVR12 was defined as plasma HCV RNA level <LLOQ 12 weeks after the last dose of study drug.|12 weeks after last actual dose of study drug|All participants in the ITT population who were HCV GT1-infected, prior SOF-treatment experienced; participants with missing data after backwards imputation were imputed as nonresponders.||percentage of participants||95% Confidence Interval|Number
635763|NCT02604017|Secondary|Percentage of Participants With SVR12 in Co-infected HCV GT1/Human Immunodeficiency Virus Type 1 (HIV-1) Participants|SVR12 was defined as plasma HCV RNA level <LLOQ 12 weeks after the last dose of study drug.|12 weeks after last actual dose of study drug|All participants in the ITT population who were co-infected HCV GT1/HIV-1; participants with missing data after backwards imputation were imputed as nonresponders.||percentage of participants||95% Confidence Interval|Number
635764|NCT02604017|Secondary|Percentage of Participants With SVR12|SVR12 was defined as plasma HCV RNA level <LLOQ 12 weeks after the last dose of study drug.|12 weeks after last actual dose of study drug|All participants in the ITT population; participants with missing data after backwards imputation were imputed as nonresponders.||percentage of participants||95% Confidence Interval|Number
635765|NCT02604017|Secondary|Percentage of Participants With SVR12 in Mono-infected HCV GT1 Participants|SVR12 was defined as plasma HCV RNA level <LLOQ 12 weeks after the last dose of study drug.|12 weeks after last actual dose of study drug|All participants in the ITT population who were mono-infected HCV GT1; participants with missing data after backwards imputation were imputed as nonresponders.||percentage of participants||95% Confidence Interval|Number
635766|NCT02604017|Primary|Percentage of Participants With SVR12: Noninferiority of 8-Week Treatment Arm to 12-Week Treatment Arm in Mono-infected HCV GT1, DAA-Naïve Participants|SVR12 was defined as plasma HCV RNA level <LLOQ 12 weeks after the last dose of study drug. The primary efficacy endpoint was noninferiority of the percentage of mono-infected HCV GT1, DAA-naïve participants who achieved SVR12 in the 8-week treatment arm compared with the 12-week treatment arm.|12 weeks after the last actual dose of study drug|All participants in the ITT population who were mono-infected HCV GT1, DAA-naïve; participants with missing data after backwards imputation were imputed as nonresponders.||percentage of participants||95% Confidence Interval|Number
635767|NCT02604017|Primary|Percentage of Participants With SVR12: Noninferiority of 8-Week Arm to 12-Week Arm in Mono-infected HCV GT1, DAA-Naïve Participants, Excluding Those Who Discontinued/Experienced Virologic Failure by Week 8 or Had No HCV RNA Value at Week 12 or Later|SVR12 was defined as plasma HCV RNA level <LLOQ 12 weeks after the last dose of study drug. The primary efficacy endpoint was noninferiority of the percentage of mono-infected HCV GT1, DAA-naïve participants (excluding those who discontinued/experienced virologic failure by Week 8 or had no HCV RNA value at Week 12 or later) who achieved SVR12 in the 8-week treatment arm compared with the 12-week treatment arm.|12 weeks after last actual dose of study drug|All participants in the ITT population who were mono-infected HCV GT1 DAA-naïve (excluding those who discontinued/experienced virologic failure by Week 8 or had no HCV RNA value at Week 12 or later); participants with missing data after backwards imputation were imputed as nonresponders.||percentage of participants||95% Confidence Interval|Number
635768|NCT02604017|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Mono-infected Hepatitis C Virus Genotype 1 (HCV GT1), Direct-acting Antiviral Agent (DAA) Naïve Participants in the 12-Week Treatment Arm|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug. The primary efficacy endpoint was noninferiority of the percentage of participants who achieved SVR12 in the 12-week treatment group compared with the historical control rate for HCV GT1 subjects who are treatment-naïve or treated with pegylated-interferon alfa-2a or alfa-2b and ribavirin (pegIFN/RBV).|12 weeks after the last actual dose of study drug|All participants in the ITT population who were mono-infected HCV GT1, DAA-naïve; participants with missing data after backwards imputation were imputed as nonresponders.||percentage of participants|||Number
635769|NCT02603666|Primary|Elastographic Value in kPa Measured by Fibroscan|Elastographic values given in kPa by Fibroscan. All patients undergo elastographic measurement of the liver and ultrasound of the liver. The grade of fibrosis is to be established by setting the cut-off for cystic fibrosis patients.|Within 28 days in connection with their annual evaluation at a single point of time|||kPa||95% Confidence Interval|Mean
635778|NCT02598934|Secondary|Percent Change From Baseline to Month 6 in Serum Bone-Specific Alkaline Phosphatase (BSAP)|Serum BSAP is a measure of bone resorption and is measured as ng/mL. Percent change from baseline to Month 6 was calculated using Month 6 value minus baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group).|Baseline, Month 6|ITT population observed cases: all participants of ITT population with available data for this outcome measure.||percent change||Standard Deviation|Mean
635800|NCT02597543|Secondary|Myocardial Ischemia/Infarction|Myocardial ischemia or infarct occurring from time of enrollment (when cardiac MRI performed) over subsequent 10 month period.|10 months after enrollment (when cardiac MRI was performed)|||Participants|||Count of Participants
649361|NCT02082912|Secondary|Change in Depressive Symptoms||Baseline and at end of 3 weeks of treatment||||||
635770|NCT02602223|Primary|Amount of Preservation of Alveolar Ridge Dimensions Following Ridge Preservation Procedures i.e., Vertical Ridge Height Change in Millimeters as Assessed Through Analysis of CBCT Scans.|Radiographic stent with a radiopaque reference plane (RRP) will be used to obtain pre-extraction CBCT scans. Approximately 3.5(±0.5)-months post extractions, a second CBCT will be taken. Radiographic Analyses will be done using radiographic image analysis software by a calibrated examiner. Initial relative crest iRC will be determined as described above from the initial CBCT. In the second CBCT, vertical distance from the iRC from initial CBCT will be used to recreate the iRC. New relative crest will be determined for each of the three planes (nRC) as above. The difference between iRC and nRC indicates change in vertical dimension at each plane (RΔVD) i.e., iRC - nRC = (RΔVD). Positive (RΔVD) values indicate relative loss of crestal bone height and negative (RΔVD) values indicate relative gain of crestal bone height.|3-4 months|Change in vertical dimension at each plane (RΔVD) i.e., iRC - nRC = (RΔVD). Positive (RΔVD) values indicate relative loss of crestal bone height and negative (RΔVD) values indicate relative gain of crestal bone height.||millimeters||Standard Deviation|Mean
635771|NCT02602223|Primary|Amount of Preservation of Alveolar Ridge Dimensions Following Ridge Preservation Procedures i.e., Horizontal Ridge Width Height Change in Millimeters as Assessed Through Analysis of CBCT Scans.|Radiographic stent with radiopaque reference plane (RRP) will be used to obtain pre-extraction CBCT scans. Approximately 3-months post extractions, a second CBCT will be taken. Radiographic Analyses will be done using radiographic image analysis software by a calibrated examiner. The initial relative crest (iRC) reference point will be determined. The buccal and lingual crests at the central plane of site will be marked and distances from this crest to RRP will be measured in mm. The average distance of the buccal crest height and the lingual crest height will be calculated and that value will be used to determine the iRC for that site. Initial Bucco-lingual (iRBL) measurements will be recorded at 1 mm, 3 mm and 7 mm from iRC in all five planes. The final bucco-lingual (fRBL) measurements will be recorded on the second CBCT, using the same method as described before and using the iRC reference. Differences between iRBL and the fRBL reflect change in horizontal ridge width (RΔHD).|3-4 months|Change in horizontal ridge width (RΔHD).||millimeters||Standard Deviation|Mean
635772|NCT02602223|Primary|Post Operative Pain|A visual Analog score (VAS) pain scale form (scale of 1 to 10) will be provided with instructions to record pain levels on both surgical sites every day for 2-weeks post-surgery. VAS score of 10 indicates highest level of pain and 0 indicates no pain. Subjects will also asked to log any pain medications taken in that 2-week period. Subjects will be seen at 1&2 weeks for post-operative evaluation and VAS forms will be collected. Data will be reported as Average VAS score.|0-2 weeks|VAS score at 24 hours post operative||Units on a scale of 10||Standard Deviation|Mean
635773|NCT02602223|Primary|Evaluation of Preservation of Ridge Quality Through Histological Analysis for Microarchitectural Parameters Expressed as Percentages.|Approximately 3.5(±0.5)-months post extractions, a 2.5x10mm core of bone will be removed from the center of the residual ridge using a 2.5mm inner-diameter trephine bur. Cores will be immediately placed into 10%-formalin. Cores will be process and embedded in polymethylmethacrylate and sectioned to 5μm thickness and sections will be stained with Goldener’s Trichrome. With the Goldener’s trichrome, mineralized bone appears as green or blue regions, osteoid appears orange–red, nuclei appears blue-grey and graft remnants appear grey. Additional differentiation between graft and new bone will be achieved by morphologically assessing each sample individually. A slide scanner will be used to image the sample (20x magnification), and a software program will be used for the histomorphometric analysis, to quantify the amount of total mineralized bone, new bone / osteoid, soft tissue, and residual graft remnants in percentages .|3-4 months|New bone/osteoid Percentages||Percentage of New bone||Standard Deviation|Mean
635774|NCT02602223|Primary|Evaluation of Preservation of Ridge Quality Through Microtomographic Analysis for Microarchitectural Parameters Expressed as Percentages.|Approximately 3-months post extractions, a 2.5x10mm core of bone will be removed from the center of the residual ridge using a 2.5mm inner-diameter trephine bur. Cores will be immediately placed into 10%-formalin. A high-resolution microtomographic scanner will be used and images will be scanned at a voxel size of 8µm3. Moist bone cores will be wrapped in paraffin and scanned in air. Cores will be rotated in 0.7 degree increments with 450milli second time exposition. A 0.5m aluminum filter will be used to remove image noise. After scanning, 3D microstructural image data will be reconstructed using software. Structural indices will be calculated using a software. The micro-architectural variables; bone volume density (BV/TV), and bone surface density (BS/BV); will be quantified and reported as percentages.|3-4 month|The micro-architectural variable; bone volume density (BV/TV),was quantified and is reported as percentages.||Percentage of BV/TV||Standard Deviation|Mean
635775|NCT02602223|Primary|Amount of Preservation of Alveolar Ridge Dimensions i.e..,Clinical Horizontal Ridge Width Change in Millimeter as Result of Ridge Preservation Procedures|A radiographic stent will be fabricated with reproducible access holes ≈5 mm apical to the mid-facial and mid-lingual gingival margin of the teeth to be extracted. On day of surgery, a calibrated examiner masked to treatment allocation, will record initial clinical bucco-lingual (iCBL) ridge measurements in millimeters (mm), through the access holes in the stent, using calipers. Approximately 3.5(±0.5)-months post extractions, the calibrated examiner masked to treatment allocation, will record the final clinical bucco-lingual (fCBL) ridge measurements in mm using the calipers as described earlier. The difference between fCBL and iCBL will be calculated as change in clinical horizontal ridge width dimensions in mm (cΔHD).|3-4 months|change in clinical horizontal ridge width dimensions in mm - cΔHD||millimeters|Participants|Standard Deviation|Mean
635777|NCT02598934|Secondary|"Percentage of Participants Who Were Very Confident or Confident to Items on the Boniva Confidence Scale (BCS) at Month 6"|The BCS is designed to measure the participant's confidence level that Boniva (ibandronate) therapy is effective in treating osteoporosis and reducing the risk of fracture. Response options ranged on a 5-point scale from ‘Not At All Confident’ to ‘Very Confident.’ A Boniva confidence responder was defined as a participant who reported a response of 'confident' or 'very confident' on the 2 items in BCS. (1) ibandronate was effective in treating osteoporosis and (2) ibandronate reduces the risk of breaking a bone.|Month 6|ITT population||percentage of participants|||Number
639966|NCT02368314|Secondary|Frequency of Distal DVT|Frequency of distal DVT (symptomatic or asymptomatic)|During the treatment period (14 days) and follow-up period (till 60-th day)||||||
635779|NCT02598934|Secondary|Percent Change From Baseline to Month 6 in Serum Osteocalcin|Serum osteocalcin is a measure of bone resorption and is measured as ng/mL. Percent change from baseline to Month 6 was calculated using Month 6 value minus baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group).|Baseline, Month 6|ITT population observed cases: all participants of ITT population with available data for this outcome measure.||percent change||Standard Deviation|Mean
635780|NCT02598934|Secondary|Percent Change From Baseline to Month 6 in Serum Procollagen Type 1 N-terminal Propeptide (P1NP)|Serum P1NP is a measure of bone resorption and is measured as ng/mL. Percent change from baseline to Month 6 was calculated using Month 6 value minus Baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group).|Baseline, Month 6|ITT population observed cases: all participants of ITT population with available data for this outcome measure.||percent change||Standard Deviation|Mean
635781|NCT02598934|Secondary|Percent Change From Baseline to Month 6 in Urine N-terminal Telopeptide of Type 1 Collagen (NTX)|Urine NTX is a measure of bone resorption and is measured as millimoles bone collagen equivalents per millimoles creatinine. Percent change from baseline to Month 6 was calculated using Month 6 value minus baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group).|Baseline, Month 6|ITT population observed cases: all participants of ITT population with available data for this outcome measure.||percent change||Standard Deviation|Mean
635782|NCT02598934|Primary|Percent Change From Baseline to Month 6 in Serum C-terminal Telopeptide of Type 1 Collagen (CTX)|Serum CTX is a measure of bone resorption and is measured as nanograms per milliliter (ng/mL). Percent change from Baseline to Month 6 was calculated using Month 6 value minus baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group).|Baseline, Month 6|ITT population observed cases: all participants of ITT population with available data for this outcome measure.||percent change||Standard Deviation|Mean
635783|NCT02598622|Primary|Grade of Neurotoxicity Will be Captured by an Adaptation of the Total Peripheral Neuropathy Score.||Days 1 - 21|Only 2 out of 8 participants were able to complete protocol related therapy and therefore no data were collected for analysis.|||||
635784|NCT02598128|Other Pre-specified|Ease of Use of RELiZORB (Per-Protocol Population)|Effect of enteral nutrition on select activities of daily living. Patients judged the size of breakfast after overnight enteral tube feeding with the following choices: No breakfast; Small breakfast; Normal breakfast; Big breakfast; Other.|Period C: Single assessment on Day 19 or 20|Per Protocol Population.||Participants|||Count of Participants
635785|NCT02598128|Primary|Long Chain Polyunsaturated Fatty Acid Plasma Concentration (Intent to Treat Population)|AUC analysis of plasma fatty acid concentration for DHA + EPA baseline adjusted over 24-hours|Day 1 first intervention and Day 9 second intervention.|||ug*h/mL||Standard Deviation|Mean
635786|NCT02598128|Primary|Number of Patients With Adverse Events and Unanticipated Adverse Device Effects|1) Frequency and severity of adverse events; 2) Patients with at least one unanticipated adverse device effects (UADE)|27 days|Safety Population||Participants|||Count of Participants
635787|NCT02597907|Primary|The Incidence of Postoperative Nausea and Vomiting|The incidence of postoperative nausea and vomiting during 24 hours postoperatively|24 hours|||Participants|||Count of Participants
635788|NCT02597855|Secondary|Best Corrected Visual Acuity|Best corrected visual acuity assessed at baseline, 3 months, and 6 months|baseline, 3 months, and 6 monthsc|Participants who were finished 6 months follow up period.||LogMAR||Standard Deviation|Mean
635789|NCT02597855|Primary|Regression Rate of Polyp on Indocyanine Green Angiography|Indocyanine green angiography performed initially and at 3 months were used to determine the polyp regression. The definition of complete polyp regression is that the polyps at initial visit disappeared at 3 months on indocyanine green angiography. The partial regression means the polyps remain, but the size decreased >30%.|3 months|Participants who were finished 6 months follow up period.||participants|||Number
635790|NCT02597582|Secondary|Postoperative Injected Analgesic Amount|The amount of injected form analgesic used (Meperidine 50 mg/ampule)|2 weeks|||Ampule||Standard Deviation|Mean
635791|NCT02597582|Secondary|Postoperative Oral Analgesic Consumption|The amount of analgesic consumption via oral ingestion after operation|2 weeks|||capsules||Standard Deviation|Mean
635792|NCT02597582|Secondary|Postoperative Subjective Pain Status|Visual analogue scale of subjective pain status after operation|2 weeks|Pain visual analogue scale (VAS) (no pain: 0, intolerable pain: 10)||units on a scale||Standard Deviation|Mean
635793|NCT02597582|Secondary|Postoperative Drainage Amount|The amount of drainage from closed system drainage tube|2 weeks|||ml||Standard Deviation|Mean
635794|NCT02597582|Secondary|Intraoperative Blood Loss|Intraoperative blood loss was estimated by the sum of the volume in the suction bottle and the increased weight of wet gauzes containing blood after neck dissection.|1 day|||ml||Standard Deviation|Mean
635795|NCT02597582|Primary|Opreation Duration|The duration from incision of cervial skin till the completion of lymph node dissection|1 day|||minutes||Standard Deviation|Mean
635796|NCT02597543|Secondary|Mean Segmental T1 Values of the Left Ventricle|T1 values are obtained at the time of the cardiac MRI and indicate the amount of myocardial edema. This was a one time measurement. Outcome measure time frame indicates when T1 values of the left ventricle were obtained in relation to heart-transplantation.|Range of 1 to 12 years after heart transplantation for subjects and an average of 4 years after heart-transplantation.|||Percentage of myocardium||Standard Deviation|Mean
635797|NCT02597543|Secondary|Late Gadolinium Enhancement|Late gadolinium enhancement demonstrates myocardial scar by cardiac MRI. This is measured the day of the cardiac MRI scan and is a one time measurement. Time frame is measurement of late gadolinium enhancement from date of heart-transplantation.|Range of 1 to 12 years after heart transplantation for subjects and an average of 4 years after heart-transplantation.|||percentage of myocardium||Standard Deviation|Mean
635798|NCT02597543|Secondary|Re-transplantation|Re-transplantation of the heart after enrollment (date of cardiac MRI). Measured 10 months after enrollment.|10 months after enrollment (from date of cardiac MRI)|||Participants|||Count of Participants
635812|NCT02596945|Secondary|Percentage of Participants With Hemoglobin Values in the Range of 11-13 g/dL During the Evaluation Period of Visit 7 (Month 7) to Visit 9 (Month 9)||Month 7 to Month 9|MES population.||percentage of participants|||Number
635801|NCT02597543|Primary|Myocardial Perfusion Reserve|Myocardial perfusion reserve calculates the increase in myocardial perfusion after stress in comparison to rest. Outcome measure time frame specifies when the myocardial perfusion reserve was obtained in relation to date of heart-transplant for each patient. This was a one time measurement made after heart-transplantation.|Range of 1 to 12 years after heart transplantation for subjects and an average of 4 years after heart-transplantation.|||arbitrary units||Standard Deviation|Mean
635802|NCT02596958|Secondary|Overall Survival|Overall survival was defined as the time (months) between the start of therapy and the date of death.|Up to 74 months|Analysis population was defined as all participants included in the observational study, regardless of whether they finished it. Here 'number of participants analyzed' = participants assessed for this outcome measure.||months||Standard Deviation|Mean
635803|NCT02596958|Secondary|Percentage of Participants Who Died||Up to 74 months|Analysis population was defined as all participants included in the observational study, regardless of whether they finished it. Here, number of participants analyzed = participants with non-missing tumor response data.||percentage of participants|||Number
635804|NCT02596958|Secondary|Progression Free Survival (PFS)|PFS was defined as the time (months) between the start of therapy and progression (unequivocal progression of existing non­target lesions) or death. Progression: at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started. PFS was estimated using Kaplan-Meier method.|Up to 74 months|Analysis population was defined as all participants included in the observational study, regardless of whether they finished it. Here, number of participants analyzed = participants with non-missing tumor response data.||months||95% Confidence Interval|Median
635805|NCT02596958|Secondary|Percentage of Participants With Disease Control|Disease control was defined as having achieved CR (commonly defined as disappearance of all target lesions, all non-target lesions, and no new lesion), PR (commonly defined as at least a 30% decrease in the sum of the LD of target lesions, no progression in non-target lesion, and no new lesion), or SD (commonly defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, in addition to no new target lesions) during the course of observation which were assessed as per investigator discretion. PD: commonly defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started and NE.|Up to 74 months|Analysis population was defined as all participants included in the observational study, regardless of whether they finished it. Here, number of participants analyzed = participants with non-missing tumor response data.||percentage of participants|||Number
635806|NCT02596958|Secondary|Percentage of Participants With Eastern Cooperative Group(ECOG) Performance Status Grades|ECOG Performance Status measured on-therapy (time between first dose and last dose date with a 30-day lag) assessed participant's performance status on 5 point scale: 0 is equal to (=) fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (greater than [>] 50% of waking hours [hrs]), capable of all self care, unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair >50% of waking hrs; 4=completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=dead.|Up to 74 months|Analysis population was defined as all participants included in the observational study, regardless of whether they finished it. Here, number of participants analyzed = participants with non-missing tumor response data.||percentage of participants|||Number
635807|NCT02596958|Secondary|Percentage of Participants With Best Tumor Response Over Time|Best tumor response (assessed as per clinical routine of the individual center) was categorized according to the following criteria at the investigator discretion: complete response (CR: commonly defined as disappearance of all target lesions, all non-target lesions, and no new lesion), partial response (PR: commonly defined as at least a 30 percent [%] decrease in the sum of the longest diameter [LD] of target lesions, no progression in non-target lesion, and no new lesion), stable disease (SD: commonly defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [PD], in addition to no new target lesions). PD: commonly defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started and not evaluable (NE).|Up to 74 months|Analysis population was defined as all participants included in the observational study, regardless of whether they finished it. Here, number of participants analyzed = participants with non-missing tumor response data.||percentage of participants|||Number
635808|NCT02596958|Secondary|Number of Cycles of Systemic Therapy|Number of cycles of systemic therapy was the mean number of cycles received by participants in combination therapy with Avastin and chemotherapy and with Avastin monotherapy (maintenance).|Up to 74 months|Analysis population was defined as all participants included in the observational study, regardless of whether they finished it.||cycles||Standard Deviation|Mean
635809|NCT02596958|Secondary|Percentage of Participants Who Withdrew or Modified Treatment|Percentage of participants who withdrew treatment or experienced at least 1 dose deviation in relation to the planned Avastin therapy were reported.|Up to 74 months|Analysis population was defined as all participants included in the observational study, regardless of whether they finished it.||percentage of participants|||Number
635810|NCT02596958|Primary|Percentage of Participants With Adverse Drug Reactions (ADRs), Toxicities, Avastin-Related ADRs, and Serious ADRs|ADRs were defined as any response to a drug which was noxious and unintended, and which occurred at dose normally used related to the pharmacological properties. Serious ADRs were defined as any untoward medical occurrence or effect that at any dose resulted in death or life-threatening conditions or required hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, congenital anomaly or birth defect or medically important condition. Toxicity was defined as an adverse event that had an attribution (the relationship to investigational agent) of possible, probable or definite. Avastin-related ADRs (an adverse event with a possible relationship or a relationship to the treatment with AVASTIN) were due to Avastin. ADRs includes serious as well as non-serious ADRs.|Up to 74 months|Analysis population was defined as all participants included in the observational study, regardless of whether they finished it or not.||percentage of participants|||Number
635811|NCT02596945|Secondary|Average Duration in Days Mircera Was Administered at a Stable Dose||Up to 9 months|MES population.||days||Standard Deviation|Mean
639967|NCT02368314|Secondary|Frequency of Proximal DVT|Frequency of proximal DVT (symptomatic or asymptomatic)|During the treatment period (14 days) and follow-up period (till 60-th day)||||||
635813|NCT02596945|Primary|Percentage of Participants With Hemoglobin Values in the Range of 11-12 Grams Per Deciliter (g/dL) During the Evaluation Period of Visit 7 (Month 7) to Visit 9 (Month 9)||Month 7 to Month 9|Modified Efficacy Set (MES) population (All participants who received at least 1 dose of study drug and for whom at least 2 hemoglobin measurements were available during the evaluation period (Month 7 to Month 9).||percentage of participants|||Number
635814|NCT02596620|Primary|Percentage of Participants With Successful Eradication of H. Pylori|Successful eradication of H. pylori is defined as (1) negative results of both rapid urease test and histology, or (2) a negative result of urea breath test at 4 weeks.|Negative results of H.pylori 4 weeks after eradication|||percentage of eradication||95% Confidence Interval|Number
635815|NCT02596451|Primary|Absolute Change in the Total WOMAC (Western Ontario and McMaster Universities Arthritis Index) Pain Subscale Score for the Target Knee|The total WOMAC Pain Subscale score was determined by summing the individual scores from each of the five questions using a 5-point Likert scale (i.e., ‘none’=0; ‘mild’=1, ‘moderate’=2; ‘severe’=3; ‘extreme’=4) comprising the WOMAC Pain Subscale Rating for the Target Knee.|Baseline and week 4|||units on a scale||Standard Deviation|Mean
635816|NCT02595502|Primary|Overall Comfort|Overall comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. Please note this was a 2 treatment by 3 period study design. Therefore, some subjects were randomized to receive one of the study lenses twice, hence the number of observations were summarized per lens type. For the senofilcon A lens 134+138+134=406 (Observations- 1 per subject per period, however 1 observation was not recorded) from period 1, 2 and 3 respectively. For the delefilcon A lens 138+134+138=410 from period 1, 2 and 3 respectively.|1 Week|The analysis population consists of subjects that completed the study without a major protocol deviation.||units on a scale|Number of Observations|Standard Deviation|Mean
635817|NCT02595450|Secondary|Overall Survival (OS) Time|Time from the start of study treatment to date of death due to any cause. Kaplan-Meier estimates were used for calculating OS.|Up to 6 years|As per the study design, no follow up data was collected and documentation ended with end of erlotinib therapy. Due to less events, median OS was not reached.||months||Full Range|Median
635818|NCT02595450|Primary|Percentage of Participants With Best Overall Response|Percentage of participants with best overall response of complete remission (CR), partial remission (PR), stable disease (SD), or progressive disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) were reported. Per RECIST Version 1.1: CR was defined as complete disappearance of all target lesions and non-target disease. All nodes, both target and non-target, must decrease to normal (short axis less than [<] 10 millimeter [mm]). No new lesions. PR was defined as greater than or equal to (>=) 30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. PD was defined as at least 20% increase in the sum of diameters of target lesions, or unequivocal progression of existing non-target lesions. SD was defined as not qualifying for CR, PR, PD.|Up to 6 years|Analysis population included participants who received at least 2 documented treatment cycles. Missing data was not reported.||percentage of participants|||Number
635819|NCT02595450|Primary|Progression-free Survival (PFS) Time|Time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first. Progression was defined as at least 20 percent (%) increase in the sum of diameters of target lesions, or unequivocal progression of existing non-target lesions. Kaplan-Meier estimates were used for calculating PFS.|Up to 6 years|Analysis population included participants who received at least 2 documented treatment cycles.||months||95% Confidence Interval|Median
635820|NCT02594826|Secondary|Knowledge About Cervical Cancer|"Women's knowledge will be measured using a true/false scale. Responses will be combined to form a knowledge score.
Analysis of secondary outcome data is ongoing."|12 months||10/2017||||
635821|NCT02594826|Primary|Number of Women Who Receive a Pap Smear Test|Number of women who receive a Pap smear test in each group|12 months|||participants|||Number
635822|NCT02592655|Primary|Investigator Limb Occlusion Assessment|Duplex and color flow ultrasound are used to assess distal blood flow at the popliteal artery for 1 sustained minute following the application of each tourniquet intervention to the middle upper thigh. If no flow is observed for 1 sustained minute then it is considered a successful occlusion. This assessment was made by the investigator and ultrasonographer applying the intervention.|For 1 sustained minute after application of each tourniquet intervention.|||Participants|||Count of Participants
635823|NCT02592655|Primary|Radiologist Limb Occlusion Assessment|"Duplex and color flow ultrasound are used to assess distal blood flow at the popliteal artery for 1 sustained minute following the application of a each tourniquet intervention to the middle upper thigh. If no flow is observed for 1 sustained minute then it is considered successful occlusion. A still image is then saved for later evaluation by the blinded outcome assessor.
The 5 cm tape was discontinued after the 4th participant because the tape was considered to unacceptably narrow after stretching and this was considered a mechanical failure even if occlusion was observed. Therefore the 5 cm tape data was not evaluated by the radiologist."|For 1 sustained minute after application of each tourniquet intervention.|"One ultrasound image from one of the participants of the pneumatic tourniquet (ATS) group failed to capture anatomy and was therefore not included in the analysis.
One ultrasound image from one of the participants of the windlass tourniquet (SOFTT-W) group failed to capture anatomy and was therefore not included in the analysis."||Participants|||Count of Participants
635824|NCT02591537|Secondary|Scar Quality Analysis; Colorimeter|Scar quality was to be assessed for each study participant using a colorimeter at day 42. A colorimeter was to be used to measure the extent of erythema, and melanin content, of the skin. Unfortunately, the data for this study endpoint were not collected properly, and despite our best efforts, there is no way to resolve this issue. Thus, no data can be reported for this study outcome.|Day 42|Data were not collected.|||||
635948|NCT02581475|Secondary|Withdrawal Time in the Proximal Colon Among 2 Group.||During routine screening and surveillance colonoscopy, for up to 1 hour, withdrawal time was recorded. About 1 month after this study, mean withdrawal time was calculated.|||minute||Standard Deviation|Mean
635825|NCT02591537|Secondary|Scar Quality Analysis; Elastometer|Scar quality was to be assessed for each study participant using an elastometer at day 42. An elastometer is used to assess scar elasticity. Unfortunately, the data for this study endpoint were not collected properly, and despite our best efforts, there is no way to resolve this issue. Thus, no data can be reported for this study outcome.|Day 42|Data were not collected.|||||
635826|NCT02591537|Secondary|Scar Quality Analysis; Visual Analogue Scale|Scar quality of each study participant was assessed by using the Visual Analogue Scale (VAS) at day 42. The VAS is an 11-point scale that ranges from 0 (normal skin) to 10 (worst possible scar). The values on the scale indicate the observer's global impression of the scar (lower numbers are better than higher numbers).|Day 42|Each participant was assigned to both study groups (acted as her own control), as four wounds on one side of each participant were treated with OxyGenesys dressing, and four wounds on the opposite side of each participant were treated with the Tegaderm control dressing. One participant did not report for her day 42 measurement.||units on a scale|wounds|Standard Deviation|Mean
635827|NCT02591537|Secondary|Scar Quality Analysis; Modified Vancouver Scar Scale (MVS)|Scar quality will be assessed and analyzed between the two groups using the Modified Vancouver Scar Scale at day 42. The MVS assessment is the tool that the Investigator will use to evaluate scar pliability (0 points = normal, 1 = supple, 2 = yielding, 3 = firm, 4 = adherent), height (0 = normal, 1 = 1-2 mm, 2 = 3-4 mm, 3 = 5-6 mm, 4 = > 6 mm), vascularity (0 = normal, 1 = pink, 2 = red, 3 = purple), and pigmentation (0 = normal, 1 = slight, 2 = moderately, 3 = severely). An average score for each participant was calculated by combining scores from each subscale. Average participant scores in each study group were combined to produce a grand mean and standard deviation for each group (reported below).|Day 42|Each participant was assigned to both study groups (acted as her own control), as four wounds on one side of each participant were treated with OxyGenesys dressing, and four wounds on the opposite side of each participant were treated with the Tegaderm control dressing. One participant did not report for her day 42 measurement.||units on a scale|wounds|Standard Deviation|Mean
635828|NCT02591537|Secondary|Biopsy & Histology of Wounds.|Biopsies will be taken from all wounds at day 28. Analysis of tissue samples will specifically evaluate differences and rates of collagen deposition, angiogenesis and re-epithelialization between the two study arms.|Day 28|Each participant was assigned to both study groups (acted as her own control). Samples were collected, but not analyzed because the comparative broad healing endpoints did not provide compelling evidence for tissue processing. No data are presented because the Outcome Measure has zero total participants analyzed.|||wound biopsies||
635829|NCT02591537|Secondary|Pain on Test Versus Control Side Using a Wong-Baker Scale.|Subjects will report pain level on each side of their abdomen at day 14. The Wong-Baker scale is: 0 points = no hurt, 2 = hurts little bit, 4 = hurts little more, 6 = hurts even more, 8 = hurts whole lot, 10 = hurts worst. A grand mean and standard deviation (reported below) were determined by combining participant scores.The identical group mean and standard deviation values reported below are correct.|Day 14|Each participant was assigned to both study groups (acted as her own control), as four wounds on one side of each participant were treated with OxyGenesys dressing, and four wounds on the opposite side of each participant were treated with the Tegaderm control dressing. Five participants did not report their day 14 measurements.||units on a scale|wounds|Standard Deviation|Mean
635830|NCT02591537|Secondary|Wound Degree of Epithelialization Percent Change by Digital Photography at Each Time Point Post Wounding.|Wound degree of epithelialization percent change by digital photography at day 14.|Day 14|Each participant was assigned to both study groups (acted as her own control), as four wounds on one side of each participant were treated with OxyGenesys dressing, and four wounds on the opposite side of each participant were treated with the Tegaderm control dressing.||percentage of epithelialization|wounds|Standard Deviation|Mean
635831|NCT02591537|Primary|Healing in Days.|Wound healing will be defined as 90% re-epithelialization. Mean time to healing will be compared between the OxyGenesys treated sites and the control treated sites.|14 days|Each participant was assigned to both study groups (acted as her own control), as four wounds on one side of each participant were treated with OxyGenesys dressing, and four wounds on the opposite side of each participant were treated with the Tegaderm control dressing.||days|wounds|Standard Deviation|Mean
635832|NCT02591238|Primary|Smoke-induced Vascular Injury and Melatonin's Effect in This Process Assessed by the Concentration of LDL-C.||Three months.|Bellow concentration data of LDL-C was after treatment with oral melatonin 2 weeks.||mmol/L||Standard Deviation|Mean
635833|NCT02591238|Primary|Smoke-induced Vascular Injury and Melatonin's Effect in This Process Assessed by the Concentration of TG.||Three months.|Bellow concentration data of TG was after treatment with oral melatonin 2 weeks.||mmol/L||Standard Deviation|Mean
635834|NCT02591238|Primary|Smoke-induced Vascular Injury and Melatonin's Effect in This Process Assessed by the Concentration of TC.||Three months.|Bellow concentration data of TC was after treatment with oral melatonin 2 weeks.||mmol/L||Standard Deviation|Mean
635835|NCT02591238|Primary|Smoke-induced Vascular Injury and Melatonin's Effect in This Process Assessed by the Concentration of FFA.||Three months.|Below concentration data of FFA was after treatment with oral melatonin 2 weeks.||umol/L||Standard Deviation|Mean
635836|NCT02591238|Primary|Smoke-induced Vascular Injury and Melatonin's Effect in This Process Assessed by the Concentration of Glu.||Three months.|Bellow concentration data of Glu was after treatment with oral melatonin 2 weeks.||mmol/L||Standard Deviation|Mean
635837|NCT02591238|Primary|Smoke-induced Vascular Injury and Melatonin's Effect in This Process Assessed by the Concentration of Fbg.||Three months|Bellow concentration data of Fbg was after treatment with oral melatonin 2 weeks.||g/L||Standard Deviation|Mean
635838|NCT02591056|Primary|Change in Combined Circumference Measurements|Combined circumference measurement is calculated as the sum of the measurements for the individual body areas of the hips, waist and upper abdomen. Change in combined circumference measurements is calculated as the difference in measurements from baseline to after completion of the 6-week procedure administration period. A negative (-) change indicates a reduction in combined circumference measurement across the evaluation period and is positive for study success. A positive (+) change indicates an increase in combined circumference measurements across the evaluation period and is negative for study success. A mean change for the study subject group of -3.0 inches or more in combined circumference measurements will be considered a clinically meaningful and statistically significant positive change indicative of study success.|Baseline and 6 Weeks|||inches||Standard Deviation|Mean
635839|NCT02590588|Secondary|Quality of Life|Evaluate quality of life according to Functional Assessment of Cancer Therapy Lymphoma Subscale (FACT-Lym) assessment tool|3 months|'There was only one patient enrolled and he did not remain on study long enough for his first protocol-specified quality of life assessment|||||
635840|NCT02590588|Secondary|Evaluate Safety and Tolerability of Agent|Number of Participants With Treatment-Related Adverse Events as Assessed by Common Toxicity Criteria for Adverse Effects (CTCAE) v4.0|3 months|There was only one patient enrolled and he did experience treatment-related adverse events.||Participants|||Count of Participants
635841|NCT02590588|Secondary|Organ Response|Number of patients with organ response using standard AL amyloidosis criteria.|3 months|Number of patients with organ response using standard AL amyloidosis criteria.|||||
635842|NCT02590588|Secondary|Progression Free Survival|Evaluate time to progression|1 year|The evaluation of progression-free survival requires that a patient responds, and then progresses. There was only one patient enrolled and he did not remain on study long enough for his first 3 month response evaluation.|||||
635843|NCT02590588|Primary|Overall Response|Evaluate hematologic response according to standard criteria|3 months|Number of participants with hematologic response is zero. There was only one patient enrolled and he did not remain on study long enough for his first 3 month response evaluation.|||||
635844|NCT02590562|Secondary|Participant's Pain Assessment|Participants scored the intensity of pain produced by RA on 10 cm VAS from 0 = no pain to 10 = extreme pain.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.||cm||Standard Deviation|Mean
635845|NCT02590562|Secondary|Participant’s Fatigue Assessment|Participants scored the fatigue on 10 cm VAS from 0 = no fatigue to 10 = very fatigue.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.||cm||Standard Deviation|Mean
635846|NCT02590562|Secondary|Health Assessment Questionnaire-Disability Index (HAQ-DI) Score|The HAQ consists of 20 questions in 8 categories (dressing and grooming, rising, eating, walking, reach, grip, hygiene, and carrying out daily activities). Each question has 4 response options, ranging from “no difficulty” to “unable to do”, corresponding to scores from 0 to 3. HAQ total score = sum of each of the 20 items' scores, with a summary score ranging from 0 to 60, where higher score indicates greater disability.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.||units on a scale||Standard Deviation|Mean
635847|NCT02590562|Secondary|Patient’s Global Assessment (PtGA) of Disease Activity|PtGA of disease activity was measured on a 0 to 10 cm VAS, with 0 cm = very well controlled and 10 cm = very poorly controlled.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.||cm||Standard Deviation|Mean
635848|NCT02590562|Secondary|Physician’s Global Assessment (PGA) of Disease Activity|PGA of disease activity was measured on a 0 to 10 centimeter (cm) VAS, with 0 cm = no disease activity and 10 cm = extreme disease activity.|Day 1 (enrollment visit)|Overall Population||cm||Standard Deviation|Mean
635849|NCT02590562|Secondary|DAS28 by Biological Agent as Monotherapy or Combination With csDMARDs|Biological agent monotherapy meant participants using a biological agent without concomitant csDMARDs. DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) or CRP (mg/dL), and PtGA of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using following formulas: DAS28-ESR = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014*PtGA of disease activity; DAS28-CRP = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(10*CRP+1) + 0.014*PtGA. DAS28-ESR was adopted to calculate DAS28 if effective ESR data was available; otherwise DAS28-CRP was adopted to calculate DAS28. Total score range: 0-10, higher score=more disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.||units on a scale||Standard Deviation|Mean
635850|NCT02590562|Secondary|DAS28 by Duration of Treatment of Biological Agent|DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) or CRP (mg/dL), and PtGA of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using following formulas: DAS28-ESR = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014*PtGA of disease activity; DAS28-CRP = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(10*CRP+1) + 0.014*PtGA of disease activity. DAS28-ESR was adopted to calculate DAS28 if effective ESR data was available; otherwise DAS28-CRP was adopted to calculate DAS28. Total score range: 0-10, higher score=more disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure in respective arms.||units on a scale||Standard Deviation|Mean
635851|NCT02590562|Secondary|Number of Participants With Duration of Treatment of Biological Agent|Number of participants with duration of treatment of biological agent <3 months, >= 3 to <6 months, >= 6 to <12 months, and >= 12 months.|Day 1 (enrollment visit)|Overall Population||participants|||Number
635852|NCT02590562|Secondary|Number of Participants Experiencing High Disease Activity to Clinical Remission Using the SDAI|The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; 0 = no disease activity and 10 = worst disease activity, and CRP (mg/dL). SDAI total score = 0-86. SDAI <=3.3 indicates clinical remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high (or severe) disease activity.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.||participants|||Number
635853|NCT02590562|Secondary|Simplified Disease Activity Index (SDAI)|The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; 0 = no disease activity and 10 = worst disease activity, and CRP (mg/dL). SDAI total score = 0-86. SDAI <=3.3 indicates clinical remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high (or severe) disease activity.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.||units on a scale||Standard Deviation|Mean
636612|NCT02540434|Secondary|24-hour Blood Transfusion Total|Number of units of RBC, Platelets, cryoprecipitate, FFP, or other blood products administered to subjects receiving study product within the first 24 hours after procedure end|24 hours||||||
635854|NCT02590562|Secondary|Number of Participants Experiencing High Disease Activity to Clinical Remission Using the CDAI|The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; 0 = no disease activity and 10 = worst disease activity. CDAI total score = 0-76. CDAI <= 2.8 indicates clinical remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high (or severe) disease activity.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.||participants|||Number
635855|NCT02590562|Secondary|Clinical Disease Activity Index (CDAI) Scores|The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and Physician’s Global Assessment (PGA) assessed on 0-10 centimeter (cm) VAS; 0 = no disease activity and 10 = worst disease activity. CDAI total score = 0-76. CDAI <= 2.8 indicates clinical remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high (or severe) disease activity.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.||units on a scale||Standard Deviation|Mean
635856|NCT02590562|Secondary|Number of Participants Experiencing High Disease Activity to Clinical Remission Using the DAS28|DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) or CRP (mg/dL), and PtGA of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using following formulas: DAS28-ESR = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014*PtGA of disease activity; DAS28-CRP = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(10*CRP+1) + 0.014*PtGA of disease activity. DAS28-ESR was adopted to calculate DAS28 if effective ESR data was available; otherwise DAS28-CRP was adopted to calculate DAS28. Total score range: 0-10, higher score=more disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.||participants|||Number
635857|NCT02590562|Secondary|Disease Activity Score Based on 28-Joint Count (DAS28)|DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) or CRP (mg/dL), and Patient’s Global Assessment (PtGA) of disease activity (measured on a 0 to 100 mm Visual Analogue Scale [VAS] where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using following formulas: DAS28-ESR = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*PtGA of disease activity; DAS28-CRP = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(10*CRP+1) + 0.014*PtGA of disease activity. DAS28-ESR was adopted to calculate DAS28 if effective ESR data was available; otherwise DAS28-CRP was adopted to calculate DAS28. Total score range: 0-10, higher score=more disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.||units on a scale||Standard Deviation|Mean
635858|NCT02590562|Secondary|Tender Joint Count (TJC)|Number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form, no tenderness = 0, tenderness = 1; total was calculated by adding all the joints for a maximum score of 28.|Day 1 (enrollment visit)|Overall Population||tender joint count||Standard Deviation|Mean
635859|NCT02590562|Secondary|Swollen Joint Count (SJC)|Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form, no swelling = 0, swelling =1; total was calculated by adding all the joints for a maximum score of 28.|Day 1 (enrollment visit)|Overall Population||swollen joint count||Standard Deviation|Mean
635860|NCT02590562|Secondary|Number of Participants With Abnormal Total Cholesterol Values|Normal range for total cholesterol is <5.2 mmol/L.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.||participants|||Number
635861|NCT02590562|Secondary|Total Cholesterol Values|Normal range for total cholesterol is <5.2 mmol/L.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.||mmol/L||Standard Deviation|Mean
635862|NCT02590562|Secondary|Number of Participants With Abnormal Triglyceride Values|Normal range for triglyceride is <1.7 mmol/L.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.||participants|||Number
635863|NCT02590562|Secondary|Triglyceride Values|Normal range for triglyceride is <1.7 millimoles per liter (mmol/L).|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.||mmol/L||Standard Deviation|Mean
635864|NCT02590562|Secondary|Number of Participants With Positive Rheumatoid Factor (RF)|RF is the auto antibody directed against immunoglobulin G (IgG) and its concentration is observed in human serum or plasma. Central lab was not used in this study; the definitions of positive RF followed participating hospitals’ standardized criteria. CRF collected data as “positive” or “negative” directly.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.||participants|||Number
635865|NCT02590562|Secondary|Number of Participants With Positive Anti-cyclic Citrullinated Peptide (ACCP) Antibody|ACCP antibodies are important markers of bone erosion in RA. Central lab was not used in this study; the definitions of positive ACCP followed participating hospitals’ standardized criteria. CRF collected data as “positive” or “negative” directly.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.||participants|||Number
635866|NCT02590562|Secondary|Number of Participants With Anemia|Anemia was defined as an adult male with hemoglobin value <120 g/L or an adult female with hemoglobin value <110 g/L.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.||participants|||Number
635867|NCT02590562|Secondary|Hemoglobin Values|Hemoglobin levels were measured in gram per liter (g/L). Anemia was defined as an adult male with hemoglobin value <120 g/L or an adult female with hemoglobin value <110 g/L.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.||g/L||Standard Deviation|Mean
637214|NCT02500368|Secondary|Corneal Staining (Extent)|"Corneal staining extent, grade as % of each zone:
C - Central, N - Nasal, T - Temporal, S - Superior, I - Interior"|Baseline and 1 week|||percentage of cornea||Standard Deviation|Mean
635868|NCT02590562|Secondary|Number of Participants With Abnormal ESR Values|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. A higher rate is consistent with inflammation. Central lab was not used in this study; the definitions of abnormal ESR followed participating hospitals’ standardized criteria. CRF collected data as directly “normal” or “abnormal”.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.||participants|||Number
635869|NCT02590562|Secondary|Erythrocyte Sedimentation Rate (ESR) Values|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. A higher rate is consistent with inflammation.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.||mm/hr||Standard Deviation|Mean
635870|NCT02590562|Secondary|Number of Participants With Abnormal CRP Values|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Central lab was not used in this study; the definitions of abnormal CRP followed participating hospitals’ standardized criteria. Case report form (CRF) collected data as directly “normal” or “abnormal”.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.||participants|||Number
635871|NCT02590562|Secondary|C-Reactive Protein (CRP) Values|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.||mg/L||Standard Deviation|Mean
635872|NCT02590562|Secondary|Number of Participants With Concurrent Interstitial Lung Disease Using Methotrexate||Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.||participants|||Number
635873|NCT02590562|Secondary|Number of Participants With Concurrent RA Extra-articular Symptoms|Number of participants with concurrent RA extra-articular symptoms including RA subcutaneous nodule, RA vasculitis, interstitial pneumonia, Felty’s syndrome, and other symptoms were presented. One participant could have more than one concurrent RA extra-articular symptoms.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.||participants|||Number
635874|NCT02590562|Secondary|Number of Participants With RA Duration|Number of participants with RA duration of <= 6 months, >6 months and <= 3 years, >3 years and <= 10 years, and 10 years.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.||participants|||Number
635875|NCT02590562|Secondary|RA Duration Since Diagnosis|RA duration = (the date of participants signing the informed consent form - date of RA diagnosis + 1) /365.25|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.||years||Standard Deviation|Mean
635876|NCT02590562|Secondary|Number of RA Related Operations|RA related operations also included prosthesis.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.||RA related operations||Standard Deviation|Mean
635877|NCT02590562|Secondary|Height||Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.||centimeters (cm)||Standard Deviation|Mean
635878|NCT02590562|Secondary|Weight||Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.||kilograms||Standard Deviation|Mean
635879|NCT02590562|Secondary|Number Participants With Past Medical History of Concurrent Chronic Disease, Tuberculosis, Hepatitis, and Imaging Manifestations of Joint Damage||Day 1 (enrollment visit)|Overall Population||participants|||Number
635880|NCT02590562|Primary|Average Daily Dose of Each Previously Concomitant NSAIDs|One participant could have received multiple concomitant NSAIDs treatment.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. n = participants with available data for specified category.||mg/day||Standard Deviation|Mean
635881|NCT02590562|Primary|Average Daily Dose of Each Currently Concomitant NSAIDs|One participant could have received multiple concomitant NSAIDs treatment.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. n = participants with available data for specified category.||mg/day||Standard Deviation|Mean
635882|NCT02590562|Primary|Average Duration of Treatment With Each Concomitant csDMARD|One participant could have received multiple concomitant csDMARDs treatment.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. n = participants with available data for specified category.||weeks||Standard Deviation|Mean
635883|NCT02590562|Primary|Average Weekly Dose of Each Concomitant csDMARD|One participant could have received multiple concomitant csDMARDs treatment.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. n = participants with available data for specified category.||mg/week||Standard Deviation|Mean
635884|NCT02590562|Primary|Number of Participants Using One, Two, or Three (or More) Concomitant csDMARDs|Number of participants using one concomitant csDMARD, two concomitant csDMARDs (methotrexate + hydroxychloroquine [HCQ], methotrexate + salazosulfapyridine [SASP], methotrexate+ leflunomide, SASP + HCQ, and other combinations), or three (or more) concomitant csDMARDs (methotrexate + SASP + HCQ, and other combinations) are presented.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.||participants|||Number
635885|NCT02590562|Primary|Average Duration of Treatment With Each Concomitant External Medicine||Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. n = participants with available data for specified category.||weeks||Standard Deviation|Mean
635928|NCT02584686|Secondary|SHIM Score Before Treatment|Assessment of the Sexual Health Inventory for men (SHIM) questionnaire before treatment for both groups. It is a questionnaire that helps asses if the patient has erectile dysfunction (ED) and assesses its degree. Results range from 1 to 25. A score of 1-7 denotes Severe ED, 8-11 Moderate ED, 12-16, Mild to Moderate ED, 17-21 Mild ED, 22-25 No ED.|Baseline|||units on the SHIM scale||Standard Deviation|Mean
635886|NCT02590562|Primary|Average Weekly Dose of Each Concomitant Glucocorticoid|Average weekly dose of each concomitant glucocorticoid (prednisone acetate, oral; betamethasone [BMZ] dipropionate and betamethasone sodium phosphate, intra-articular (IA) injection; and methylprednisolone, intravenous drip infusion, oral) is presented.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. n = participants with specified concomitant glucocorticoid treatment.||mg/week||Standard Deviation|Mean
635887|NCT02590562|Primary|Number of Participants With Reasons for Switching Types of Biological Agent Who Used a Different Biological Agent in the Past|Participants who used a different biological agent in the past and switched are shown by reason for switching. One participant could have switched types of biological agent due to multiple reasons.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.||participants|||Number
635888|NCT02590562|Primary|Number of Participants With Previous Use of the Same Biological Agent|Participants who used the same biological agent in the past and were using that same biological agent at the time of study enrollment.|Day 1 (enrollment visit)|Overall Population||participants|||Number
635889|NCT02590562|Primary|Average Duration of Treatment for Each Biological Agent|Average duration of treatment of each biological agent (adalimumab, tocilizumab, etanercept, or infliximab) is presented.|Day 1 (enrollment visit)|Overall Population. n = participants with specified treatment of biological agent.||weeks||Standard Deviation|Mean
635890|NCT02590562|Primary|Average Weekly Dose of Treatment for Each Biological Agent|Average weekly dose of treatment of each biological agent (adalimumab, tocilizumab, etanercept, or infliximab) is presented.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. n = participants with specified treatment of biological agent.||milligrams (mg) per week||Standard Deviation|Mean
635891|NCT02590562|Primary|Number of Participants Receiving a Biological Agent as Monotherapy by Types of Biological Agents|Number of participants who received a biological agent as monotherapy is presented by biological agent (adalimumab, tocilizumab, etanercept, and infliximab).|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.||participants|||Number
635892|NCT02590562|Primary|Number of Participants Receiving a Biological Agent Concomitant With Other Drugs|Number of participants receiving treatment of a biological agent concomitant with the following drugs: glucocorticoid, NSAIDs, other external medicine, or concomitant glucocorticoid and concomitant NSAIDs. The same participant could use 2 or 3 of concomitant glucocorticoid, NSAIDs and other external medicine.|Day 1 (enrollment visit)|Overall Population||participants|||Number
635893|NCT02590562|Primary|Number of Participants Receiving Biological Agent as Monotherapy or in Combination With Conventional Synthesis Disease-modifying Anti-rheumatic Drugs (csDMARDs) Therapy|Biological agent monotherapy meant participants using a biological agent without concomitant csDMARDs. Biological agent monotherapy included biological agent only, biological agent + glucocorticoid, biological agent + non-steroidal anti-inflammatory drugs [NSAIDs], and biological agent + glucocorticoid + NSAIDs.|Day 1 (enrollment visit)|Overall Population||participants|||Number
635894|NCT02588872|Secondary|Biologic Testing of Synovial Fluid Via ELISA Assays|ELISA analysis will be performed for the following biological markers: IL-1β, IL-1ra, IL-6, IL-8, TNFα|Primary outcome will be change from pre-treatment to 6-month post treatment.|IL-1B||units on a scale||Standard Error|Mean
635895|NCT02588872|Secondary|Lysholm Knee Score|This is a scale from 1-100, 100 being high function and 1 being very poor function that will be assessed via paper questionnaire at the delineated time intervals. The Primary outcome assessed will be at an average of 1-year post treatment.|This will be assessed as a change from pre-treatment visit to 1 year post treatment.|||units on a scale||Standard Error|Mean
635896|NCT02588872|Secondary|Western Ontario and McMaster Universities Arthritis Index|This is a scale from 1-100, 100 being high function and 1 being very poor function that will be assessed via paper questionnaire at the delineated time intervals. The Primary outcome assessed will be at an average of 1-year post treatment.|This will be assessed as a change from pre-treatment visit to 1 year post treatment. 6-weeks post-treatment, 6-months post treatment, and finally at 1-year post treatment will be documented for the purpose of trending data.|||units on a scale||Standard Error|Mean
635897|NCT02588872|Secondary|Visual Analogue Scale (VAS)|This is a scale from 1-100, 100 being the worst pain imaginable and 1 being no pain at all that will be assessed via paper questionnaire at the delineated time intervals. The Primary outcome assessed will be at an average of 1-year post treatment.|This will be assessed as a change from pre-treatment visit to 1 year post treatment.|||units on a scale||Standard Error|Mean
635898|NCT02588872|Primary|International Knee Documentation Committee Score (IKDC|This is a scale from 1-100, 100 being high function and 1 being very poor function that will be assessed via paper questionnaire at the delineated time intervals. The Primary outcome assessed will be at an average of 1-year post treatment.|This will be assessed as a change from pre-treatment visit to 1 year post treatment.|9 HA patients and 3 PRP from the original cohort were lost to follow up which is why 50 HA and 49 PRP patients were included in final analysis.||units on a scale||Standard Error|Mean
635899|NCT02588599|Secondary|Change in Millimeters (mm) of Clear Nail Bed|Millimeter (mm) of clear nail from the base of the toenail was determined from digital photographs of the toenail using a computer program. Change in mm of clear nail bed was calculated as the difference in mm of clear nail bed from baseline measurement to the measurement at 6 months after the end of the procedure administration phase. An increase in mm of clear nail between the two measurement points indicates that the toenail has improved and is positive for study success. A decrease in mm of clear nail between the two measurement points indicates that the toenail has worsened and is negative for study success.|Baseline and 6 Months|Each participant in this study had only one great toenail treated.||millimeters|Participants|Standard Deviation|Mean
635900|NCT02588599|Primary|Percent (%) of Toenails Attaining 3 Millimeters (mm) or More of Clear Nail Growth|Individual toenail success criteria was defined as 3 millimeter (mm) or more of clear nail growth at 6 months post-procedure administration as evaluated relative to baseline. Overall study success criteria was defined as an 60% or more of treated toenails meeting the individual success criteria.|6 Months|Each participant had only one great toenail treated in this study.||Percent of Toenails|Participants||Number
635901|NCT02587819|Post-Hoc|Change in Lesion Size.|BCC lesion area was measured at Baseline and after 28 days treatment. Percantage change in lesion area was caculated.|28 days|Final area of lesion was not recorded for one subject.||percentage change in tumour area||Standard Error|Mean
635902|NCT02587819|Primary|Pharmacokinetics - Measure Subject Antibody Response to the Active Pharmaceutical Ingredient Using an Indirect Fluorescent Immuno Assay.|The active ingredient of BSCT is sheep IgG which may causes an immunogenic response if it enters the systemic circulation. To monitor this response patient blood samples collected at Screening, Visit 2 (Baseline), Visit 6 (EOT), and at Visit 8 (EOS) was tested for anti-sheep IgG antibodies (indicative of immune response against API).|8 weeks|Anti sheep IgG antibody titres were measured from 21 subjects at screening and baseline, 20 subjects at Visit 6 (Day 29 EOT) and 19 subjects at Visit 8 (Day 57 follow up). The percentage of patients with detectable anti sheep antibodies is reported.||percentage of subjects|||Number
635903|NCT02587819|Primary|Pharmacokinetics - Measure Serum Concentration of Total Sheep IgG Using an ELISA.|To determine PK, blood levels of sheep IgG were measured in samples collected at Visit 2 (Baseline), Visit 5, predose at Visit 6 (EOT), and then at 1 h, 2 h, and 4 h after the last dose of study medication.|28 days|At all timepoints, the serum concentration of sheep IgG was too low to be quantified in most of the subjects. One subject had measurable sheep IgG at 1 hr post dose at Visit 6 (EOT) and 3 other subjects had measurable sheep IgG at predose timepoints. In outcome measure below NA represents readings less than lower limit of quantification.||ng/ml||Full Range|Median
635904|NCT02587819|Primary|Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)|Adverse events and any changes in physical examinations will be monitored, as described in the Code of Federal Regulations (CFR) Title 21 Part 312. In particular local cutaneous irritation including erythema, peeling, dryness, itching, and burning/ stinging that first occur during the study or represent a worsening from Baseline will be recorded as AEs.|8 weeks|All (21 of 21) subjects returned for safety and tolerability assessments at days 3, 8, 15 and 29 post-Baseline. 20 of 21 patients returned for final safety assessments was at 57 days post-Baseline.||participants|||Number
635905|NCT02587234|Secondary|Change in Action Research Arm Test (ARAT)|"Values given are score at post-intervention minus score at baseline, score at 1-month follow-up minus score at baseline.
The ARAT's is a 19 item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement).
Performance on each item is rated on a 4-point ordinal scale ranging from:
3: Performs test normally 2: Completes test, but takes abnormally long or has great difficulty
1: Performs test partially 0: Can perform no part of test The maximum score on the ARTS is 57 points (possible range 0 to 57)."|baseline, post-intervention, 1-month follow-up|Two subjects from the Sham PNS group were lost to follow-up.||units on a scale||95% Confidence Interval|Mean
635906|NCT02587234|Secondary|Change in Fugl Meyer Assessment Motor Score|Score at post-intervention minus score at baseline, score at 1-month follow-up minus score at baseline. The scores can range from 0 to 66, with higher scores indicating better performance. The scores are calculated by summing the scores to the 33 individual tasks.|baseline, post-intervention, 1-month follow-up|Two subjects from the Sham PNS group were lost to follow-up.||units on a scale||95% Confidence Interval|Mean
635907|NCT02587234|Primary|Change in Wolf Motor Function Test (WMFT), Timed Portion|Score at post-intervention minus score at baseline, score at 1-month follow-up minus score at baseline|baseline, post-intervention, 1-month follow-up|Two subjects in the Sham PNS group were lost to follow-up.||log(seconds)||95% Confidence Interval|Mean
635908|NCT02587117|Secondary|Burning Sensation or Pain by Using NRS (Numerical Rating Scale)|Standard self-response Numerical Rating Scale (NRS) of 0 (no oral discomfort) to 10 (worst imaginable oral discomfort) to represent the intensity of burning sensation or pain or discomfort. The mean of NRS burning sensation score was calculated after eight weeks of treatment and considered as 8th week NRS burning sensation score.|8 weeks minus baseline|||Scores on a scale||Standard Deviation|Mean
635909|NCT02587117|Primary|Change in Severity of Lesions(Degree of Reticular, Erythematous and Ulceration) by Using Piboonniyom REU Severity Score|Reticular: score 0= no white striations; score 1= white striations. Erythematous: score 0= no lesion; score 1= lesion <1 cm2; score 2: lesion 1-3 cm2; score 3= lesion >3 cm2. Ulceration: score 0= no lesion; score 1= lesion <1 cm2; score 2= lesion 1-3 cm2; score 3= lesion >3 cm2. Total weighted score was derived by sum total scores of each lesion and multiplication with weighted score 1.5 & 2.0 in total erythematous and total ulceration scores as ΣR + ΣE × 1.5 + ΣU × 2.0.Total weighted score was dependent on the number of lesions of each participant which was not the same across participants. Higher value of the total score represent worse outcome & zero value represent no lesion.|8 weeks minus baseline|||Scores on a scale||Standard Deviation|Mean
635947|NCT02581475|Secondary|Duration of the Total Colonoscopy Among 2 Group.||During routine screening and surveillance colonoscopy, for up to 1 hour, the duration of colonoscopy was recorded. About 1 month after this study, mean duration of the colonoscopy was calculated.|||minute||Standard Deviation|Mean
635913|NCT02586493|Secondary|The Percentage of Participants Who Demonstrated Correct Use of the ELLIPTA Inhaler at the End of the Study.|Participants’ ability to correctly use the ELLIPTA inhaler was assessed at Visit 1 and Visit 2 using the Correct Use Checklist by an ELLIPTA trained health care professional. The percentage was reported overall for the single treatment group along with a 95% CI for the percentage calculated using the exact binomial distribution.|Day 30|mITT Population||Percentage of Participants||95% Confidence Interval|Number
635914|NCT02586493|Secondary|The Percentage of Participants Who Rated the Ability to Tell How Many Doses Were Remaining in the ELLIPTA Inhaler as Easy or Very Easy at the End of the Study.|Participants rated how easy it was to determine how many doses were left in the ELLIPTA inhaler, using a four-point Likert scale (1-very easy, 2-easy, 3-difficult, 4-very difficult). “Easy to use” was defined as the combination of an “easy” or “very easy” rating choice. The percentage was reported overall for the single treatment group along with a 95% CI for the percentage calculated using the exact binomial distribution.|Day 30|mITT Population||Percentage of Participants||95% Confidence Interval|Number
635915|NCT02586493|Primary|Percentage of Participants With COPD Who Rate the Use of the ELLIPTA Inhaler as Easy or Very Easy, Among Those Who Demonstrate Correct Use of the Inhaler at the End of the Study.|Participants rated how easy it was to use the ELLIPTA inhaler, using a four-point Likert scale (1-very easy, 2-easy, 3-difficult, 4-very difficult). “Easy to use” was defined as the combination of an “easy” or “very easy” rating choice. The percentage was reported overall for the single treatment group along with a 95% confidence interval (CI) for the percentage calculated using the exact binomial distribution. The percentage is based off the number of participants analyzed i.e the number of subjects in the MITT population (subjects who received a dose of study medication and were randomised).|Day 30|Modified Intent-to-Treat (mITT) Population: all participants who were screened and received at least one dose of study treatment (placebo) and were randomised to receive the ELLIPTA inhaler ease of use questionnaire version A or B at Visit 2. Only participants with data available at the analysis time point were analyzed.||Percentage||95% Confidence Interval|Number
635916|NCT02585999|Secondary|NGMN Levels Over 12 Weeks of Continuous Patch Use|Liquid chromatography-tandem triple quadrupole mass spectrometry was utilized to assess NGMN|12 weeks|Analysis was performed on all samples. Thus samples for 28 participants were analyzed, including the one participant who began the study but withdrew early [lost to follow up]. The first blood draw occurred at the end of the first patch week; there was no baseline draw prior to patch use.||ng/ml||Standard Deviation|Mean
635917|NCT02585999|Primary|Change in Serum EE2 Levels Over 12 Weeks of Continuous Contraceptive Patch Use|Liquid chromatography-tandem triple quadrupole mass spectrometry was utilized to assess EE2|Total of 18 blood draws - once at the end of each patch week and two times during weeks four, eight and twelve (with the additional blood draw occurring mid-week); and blood draws performed for three continuous days after the final patch was removed|Analysis was performed on all samples. Thus samples for 28 participants were analyzed, including the one participant who began the study but withdrew early [lost to follow up]. The first blood draw occurred at the end of the first patch week; there was no baseline draw prior to patch use.||pg/ml||Standard Deviation|Mean
635918|NCT02585895|Secondary|Percent Change From Baseline in Total Cholesterol/High-density Lipoprotein Cholesterol Ratio||Baseline and Week 4|Randomized participants with non-missing data||percent change||Standard Error|Least Squares Mean
635919|NCT02585895|Secondary|Percent Change From Baseline in Non-high-density Lipoprotein-Cholesterol||Baseline and Week 4|Randomized participants with non-missing data||percent change||Standard Error|Least Squares Mean
635920|NCT02585895|Secondary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol||Baseline and week 4|Randomized participants with non-missing data||percent change||Standard Error|Least Squares Mean
635921|NCT02585895|Primary|Percentage of Participants With Apheresis Avoidance at the End of Randomized Therapy|"Avoidance of apheresis at end of randomized therapy was defined as no apheresis at week 5 and week 6. Aperesis at weeks 5 or 6 was based on LDL-C level at week 4:
participants with LDL-C ≥ 100 mg/dL at week 4 received apheresis at week 5 (participants who received apheresis QW before study entry) or week 6 (participants who received apheresis Q2W prior to study entry). If LDL-C was < 100 mg/dL at week 4, no apheresis was performed at week 5 or week 6, irrespective of assigned treatment group.
Participants who ended the study prior to week 6 were considered as not achieving apheresis avoidance."|Week 5 and week 6|All randomized participants||percentage of participants||95% Confidence Interval|Number
635922|NCT02584686|Secondary|SEP-Q3 Question After Treatment|"Number of patients answering Yes to the Sexual Encounter Profile question 3 (SEP-Q3: Did your erection last long enough for you to have successful intercourse?) after treatment.
This analysis compares the number of patients who were able to maintain their erection long enough to complete sexual intercourse after treatment in the (BTX) A group versus the Saline group."|1 month|||participants|||Number
635923|NCT02584686|Secondary|SEP-Q3 Question Before Treatment|"Number of patients answering Yes to the Sexual Encounter Profile question 3 (SEP-Q3: Did your erection last long enough for you to have successful intercourse?) before treatment."|Baseline|||participants|||Number
635924|NCT02584686|Secondary|SEP-Q2 Question After Treatment|"Number of patients answering Yes to the Sexual Encounter Profile question 2 (SEP-Q2: Were you able to insert your penis into your partner's vagina?) after treatment.
This analysis compares the number of patients who were able to perform vaginal intromission (insert the penis into the partner’s vagina) after treatment in the (BTX) A group versus the Saline group."|1 month|||participants|||Number
635925|NCT02584686|Secondary|SEP-Q2 Question Before Treatment|"Number of patients answering Yes to the Sexual Encounter Profile question 2 (SEP-Q2: Were you able to insert your penis into your partner's vagina?)"|Baseline|||participants|||Number
635926|NCT02584686|Secondary|Global Assessment Question (GAQ)|"Assessment of the effect of treatment by asking Has the treatment you have been taking improved your erectile function?. The number answering Yes in both the treatment and control groups are calculated."|1 month|||participants|||Number
635927|NCT02584686|Secondary|SHIM Score After Treatment|Assessment of the Sexual Health Inventory for men (SHIM) questionnaire before treatment for both groups. It is a questionnaire that helps asses if the patient has erectile dysfunction (ED) and assesses its degree. Results range from 1 to 25. A score of 1-7 denotes Severe ED, 8-11 Moderate ED, 12-16, Mild to Moderate ED, 17-21 Mild ED, 22-25 No ED.|1 month|||units on SHIM scale||Standard Deviation|Mean
637215|NCT02500368|Secondary|Corneal Dehydration Staining|Corneal Staining: Dehydration Staining: Yes/No|1 week|||participants|||Number
635929|NCT02584686|Secondary|EHS After Treatment|"Clinical assessment of the Erection hardness score (EHS) in both groups after ICI after 2 weeks.
The Erection Hardness Score (EHS) is designed to measure the rigidity of erection. It ranges from 0 (no erection) to 4 (Fully rigid and hard erection).
0 – Penis does not enlarge.
– Penis is larger, but not hard.
– Penis is hard, but not hard enough for penetration.
– Penis is hard enough for penetration, but not completely hard.
– Penis is completely hard and fully rigid. The average score is reported for each group."|2 weeks|||units on EHS scale||Standard Deviation|Mean
635930|NCT02584686|Secondary|EHS Before Treatment|"Clinical assessment of the Erection hardness score (EHS) in both groups after ICI at baseline.
The Erection Hardness Score (EHS) is designed to measure the rigidity of erection. It ranges from 0 (no erection) to 4 (Fully rigid and hard erection).
0 – Penis does not enlarge.
– Penis is larger, but not hard.
– Penis is hard, but not hard enough for penetration.
– Penis is hard enough for penetration, but not completely hard.
– Penis is completely hard and fully rigid. The average score is reported for each group."|Baseline|||units on EHS scale||Standard Deviation|Mean
635931|NCT02584686|Primary|Cavernosal Artery Mean PSV After Treatment|Cavernosal artery mean peak systolic velocity (PSV) after treatment, on color Doppler examination, in the patient and control groups.|2 weeks|||cm/s||Standard Deviation|Mean
635932|NCT02584686|Primary|Cavernosal Artery Mean PSV Before Treatment|Baseline mean Peak systolic velocity (PSV) in the Cavernosal arteries, on color Doppler examination, in the patient and control groups, before treatment.|Baseline|||cm/s||Standard Deviation|Mean
635933|NCT02584673|Secondary|Number of Times Needle Needs Repositioning||Immediately following intervention (within 2 hours)|This data was not collected|||||
635934|NCT02584673|Secondary|Number of Attempts|Number of instrument pricks before target is reached|Immediately following intervention (within 2 hours)|This data was not collected|||||
635935|NCT02584673|Secondary|Clinician Rating of the Device||Immediately following intervention (within 2 hours)|This data was not collected|||||
635936|NCT02584673|Primary|Time Needed to Correctly Insert the Arterial or Midline Catheter.||Immediately following intervention (within 2 hours)|||Seconds||Standard Deviation|Mean
635937|NCT02582983|Primary|Number of Participants With Premature Withdrawal Due to Adverse Events||Up to 96 weeks|The analysis population was defined as the number of participants who enrolled in the study and received at least one dose of study drug.||participants|||Number
635938|NCT02582983|Primary|Number of Participants With Serious Adverse Events (SAEs)|"A serious adverse event is any untoward medical occurrence that at any dose: results in death, or is life-threatening, or requires inpatient hospitalization or prolongation of existing hospitalization, or results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. The term life-threatening in the definition of serious refers to an event in which the patient was at risk of death at the time of the event, not an event which hypothetically might have caused death if it were more severe."|Up to 28 days after permanent discontinuation of study treatment (approximately 100 weeks)|The analysis population was defined as the number of participants who enrolled in the study and received at least one dose of study drug.||participants|||Number
635939|NCT02582970|Secondary|Mean Direct Medical Cost for Cancer Related Medical Care Utilization|Direct medical cost included cost of out-patient consultation and cost of hospitalization.|Baseline up to approximately 3 years|ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Number Analyzed = participants who were evaluable for specified categories of this outcome measure.||Thousands in New Taiwan Dollar||Standard Deviation|Mean
635940|NCT02582970|Secondary|Number of Participants With Best Overall Response|The best overall response was defined as the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Progressive disease (PD): at least a 20% increase in the disease measurement, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions, or evidence of clinical progression and unequivocal progression of existing non-TL. Complete response (CR): disappearance of all TL and non-TL. If immunocytology was available, no disease was to be detected by that methodology. Partial response (PR): at least a 30% decrease in the disease measurement, taking as reference the disease measurement done to confirm measurable disease at study entry. Stable disease (SD): neither sufficient shrinkage to qualify for PR or increase to qualify for PD.|Baseline up to approximately 3 years|ITT population.||participants|||Number
635941|NCT02582970|Secondary|Progression-Free Survival Time|Progression-free survival was defined as the duration from the date of starting first-line therapy to the date of documented disease progression or death from any cause. Disease progression was defined as at least a 20% increase in the disease measurement, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions, or evidence of clinical progression and unequivocal progression of existing non-TL. Progression-free survival was estimated using Kaplan-Meier analysis.|Baseline up to approximately 3 years|ITT population.||months||95% Confidence Interval|Median
635942|NCT02582970|Secondary|Percentage of Participants With Disease Progression or Death|Disease progression was defined as at least a 20% increase in the disease measurement, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions, or evidence of clinical progression and unequivocal progression of existing non-target lesions (TL).|Baseline up to approximately 3 years|ITT population.||percentage of participants|||Number
635943|NCT02582970|Secondary|Duration of Survival|Duration of survival was defined as the time period from the start of first line therapy to death. Duration of survival was estimated using Kaplan-Meier analysis.|Baseline up to approximately 3 years|ITT population.||months||95% Confidence Interval|Median
635944|NCT02582970|Secondary|Percentage of Participants Who Died||Baseline up to approximately 3 years|ITT population.||percentage of participants|||Number
635945|NCT02582970|Primary|Percentage of Participants With Adverse Events|An adverse event was any untoward medical occurrence attributed to study drug in a participant who received study drug.|Baseline up to approximately 3 years|ITT population.||percentage of participants|||Number
635946|NCT02581475|Secondary|Adenomas Per Patient in the Proximal Colon Among 2 Group.||During routine screening and surveillance colonoscopy, for up toafter 1 hour, the number of adenomas was recorded. About 1 month after this study, mean number of adenomas in proximal colon was calculated.|||adenomas per patient||Standard Deviation|Mean
635949|NCT02581475|Primary|Difference of Adenoma Detection Rate in the Proximal Colon Among 2 Group.|Adenoma detection rate in the proximal colon was the proportion of participants wiht more than one adenomas in proximal colon.|During routine screening and surveillance colonoscopy, for up to 1 hour, number of adenomas was recorded. About 1 month after this study, adenoma detetion rates were calculated.|||proportion of participants||95% Confidence Interval|Number
635950|NCT02581410|Secondary|Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Results past Month 3 will be later added once they become available.|From 30 days post last vaccination (Month 3) until study end at Month 14||08/2018||||
635951|NCT02581410|Secondary|Number of Subjects With Any and Related Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Results past Month 3 will be later added once they become available.|From 30 days post last vaccination (Month 3) until study end at Month 14||08/2018||||
635952|NCT02581410|Secondary|Frequencies of gE-specific CD4+ T-cells|gE-specific CD4+ T-cells, expressing at least two activation markers (from among interferon gamma [IFN-γ], interleukin-2 [IL-2], tumour necrosis factor alpha [TNF-α] and CD40L), as determined by in vitro ICS. Results past Month 3 will be later added once they become available.|At Months 0, 1, 3 and 14.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.||CD4+ T-cells/million T-cells||Standard Deviation|Mean
635953|NCT02581410|Secondary|Anti-gE Ab Concentrations|Varicella Zoster Virus.(VZV) gE Ab.Immunoglobulin G (IgG) was determined by ELISA assay. Concentrations are presented as geometric mean concentrations (GMCs), expressed in milliinternational units per millilitre (mIU/mL). Results past Month 3 will be later added once they become available.|At Months 0, 1, 3 and 14.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.||mIU/mL||95% Confidence Interval|Geometric Mean
635954|NCT02581410|Primary|Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology|From first vaccination (Month 0) up to 30 days post last vaccination (Month 3)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered.||Participants|||Count of Participants
635955|NCT02581410|Primary|Number of Subjects With Any and Related Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From first vaccination (Month 0) up to 30 days post last vaccination (Month 3)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered.||Participants|||Count of Participants
635956|NCT02581410|Primary|Number of Subjects With Unsolicited Symptoms (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|Within 30 days (Days 0-29) after each dose.|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered.||Participants|||Count of Participants
635957|NCT02581410|Primary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)] . Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|Within 7 days (Days 0-6) after each dose.|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered.||Participants|||Count of Participants
635958|NCT02581410|Primary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Relationship analysis was not performed.|Within 7 days (Days 0-6) after each dose.|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered.||Participants|||Count of Participants
635959|NCT02581410|Primary|Anti-glycoprotein E (Anti-gE) Antibody (Ab) Concentrations|Varicella Zoster Virus (VZV) gE Ab.Immunoglobulin G (IgG) was determined by ELISA assay. Concentrations are presented as geometric mean concentrations (GMCs), expressed in milliinternational units per millilitre (mIU/mL). Geometric mean antibody concentrations were adjusted for group-matching variable.|At month 3|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.||mIU/mL||95% Confidence Interval|Geometric Mean
635960|NCT02580799|Primary|Kappa Coefficient as a Measure of Agreement Between Abroad and Trial Sites (A, B, C, D and E) Concerning the IHC Test of Breast Tissue Samples|Inter-laboratory variation between the sites was assessed using Kappa test, K values to be interpreted as follows: a) <0: less than chance agreement, b) 0.01-0.20: slight agreement, c) 0.21-0.40: fair agreement, d) 0.41-0.60: moderate agreement, e) 0.61-0.80: substantial agreement, and f) 0.81-0.99: almost perfect agreement.|Up to 70 days|FAS population.||kappa coefficient|||Number
637216|NCT02500368|Secondary|Limbal Hyperemia|Limbal hyperemia assessed using scale 0-4, 0.5 steps, 0=No hyperemia, 4=Severe hyperemia.|Baseline and 1 week|||units on a scale||Standard Deviation|Mean
635961|NCT02580799|Primary|Percentage of Participants With IHC Evaluation Between Abroad and Trial Sites (A, B, C, D and E)|IHC is a staining process performed on fresh/frozen breast cancer tissue. IHC is used to show whether or not the cancer cells have HER2 and/or hormone receptors on their surface. The IHC test gives a score of 0 to 3+ that measures the amount of HER2 receptor protein on the surface of cells in a breast cancer tissue sample. Score 0: cells free from immune staining, score 1 (+): is concluded in the case of stains not completely membranous and which do not surround the membranes regardless of quantity in the cells, or weak stains surrounding the entire membrane in less than 10% of the cells. Score 2 (++): is concluded in the presence of a moderate staining surrounding the cytoplasmic membrane in at least 10%, or strong membranous staining in less than 30% of the invasive carcinoma cells. Score 3 (+++): is concluded where IHC yields strong staining surrounding the entire cytoplasmic membrane in at least 30% of the invasive carcinoma cells.|Up to 70 days|"FAS population. n included the number of participants evaluable for the specified category."||percentage of participants|||Number
635962|NCT02580799|Primary|Kappa Coefficient as a Measure of Agreement Between Sites C, D and E Concerning the IHC Test of Breast Tissue Samples|Inter-laboratory variation between the sites was assessed using Kappa test, K values to be interpreted as follows: a) <0: less than chance agreement, b) 0.01-0.20: slight agreement, c) 0.21-0.40: fair agreement, d) 0.41-0.60: moderate agreement, e) 0.61-0.80: substantial agreement, and f) 0.81-0.99: almost perfect agreement.|Up to 70 days|FAS population. Here “number of participants analyzed” included evaluable for the outcome measure.||kappa coefficient|||Number
635963|NCT02580799|Primary|Percentage of Participants With IHC Evaluation Between Site C and Others (Sites D and E)|IHC is a staining process performed on fresh/frozen breast cancer tissue. IHC is used to show whether or not the cancer cells have HER2 and/or hormone receptors on their surface. The IHC test gives a score of 0 to 3+ that measures the amount of HER2 receptor protein on the surface of cells in a breast cancer tissue sample. Score 0: cells free from immune staining, score 1 (+): is concluded in the case of stains not completely membranous and which do not surround the membranes regardless of quantity in the cells, or weak stains surrounding the entire membrane in less than 10% of the cells. Score 2 (++): is concluded in the presence of a moderate staining surrounding the cytoplasmic membrane in at least 10%, or strong membranous staining in less than 30% of the invasive carcinoma cells. Score 3 (+++): is concluded where IHC yields strong staining surrounding the entire cytoplasmic membrane in at least 30% of the invasive carcinoma cells.|Up to 70 days|"FAS population. Here “number of participants analyzed” included evaluable for the outcome measure and n included the number of participants evaluable for the specified category."||percentage of participants|||Number
635964|NCT02580799|Secondary|Percentage of Participants With Different IHC Results|"The IHC test gives a score of 0 to 3+ that measures the amount of HER2 receptor protein on the surface of cells in a breast cancer tissue sample. If the score is 0 to 1+, it’s called “HER2 negative.” If the score is 2+, it's called borderline. A score of 3+ is called “HER2 positive.” Score 0: cells free from immune staining, score 1 (+): is concluded in the case of stains not completely membranous and which do not surround the membranes regardless of quantity in the cells, or weak stains surrounding the entire membrane in less than 10% of the cells. Score 2 (++): is concluded in the presence of a moderate staining surrounding the cytoplasmic membrane in at least 10%, or strong membranous staining in less than 30% of the invasive carcinoma cells. Score 3 (+++): is concluded where IHC yields strong staining surrounding the entire cytoplasmic membrane in at least 30% of the invasive carcinoma cells."|Up to 70 days|FAS population.||percentage of participants|Participants||Number
635965|NCT02580799|Secondary|Percentage of Participants With HER2 Test Form Based on Primary Antibody|The primary antibodies included; Biocabe EP 10454, Cerb B2 (SP3 clone), Her2 Neu (SP3) Cell marque, Neomarkers (thermo) cerb B2-Ab-17 and Thermo SP3.|Up to 70 days|FAS population.||percentage of participants|Participants||Number
635966|NCT02580799|Secondary|Percentage of Participants With HER2 Test Form Based on Antigen Retrieval|Fixation of tissue samples cross-link proteins and masks antigenic sites; antigen retrieval process was performed before IHC staining in order to reverse the masking of antigenic sites. Antigen retrieval process was performed in this study using the following solutions: 1 hour Cell Conditioning 1 (CC1), 30 minutes (min) CC1 mild, 64 min CC1, CC1 Ethylenediaminetetraacetic acid (EDTA) standard, and Cell Conditioning 2 (CC2) 30 min.|Up to 70 days|FAS population.||percentage of participants|Participants||Number
635967|NCT02580799|Secondary|Percentage of Participants With HER2 Test Form Based on Different Automated Slide Stainers|Different slide stainers like Ventana, Ventana Benchmark 4XT, Ventana Benchmark Ultra and Ventana Benchmark XT were used to report HER2 test results on data registration forms (120 forms from trial sites [24 from each site] and 30 from the reference site).|Up to 70 days|FAS population.||percentage of participants|Participants||Number
635968|NCT02580799|Secondary|Percentage of Participants With HER2 Test Form Based on Country|Reference site was considered as Abroad and the tests were performed in a laboratory in Amsterdam, Netherlands. A total of 150 data registration forms (120 forms from trial sites [24 from each site] and 30 from the reference site) were collected.|Up to 70 days|FAS population.||percentage of participants|Participants||Number
635969|NCT02580799|Secondary|Percentage of Participants With Specified Density of Hormone Receptors|The specific density of hormone receptors was examined by the amount of uptake of estrogen and progesterone hormones when analyzed using IHC staining procedure. Score 0: cells free from immune staining, score 1 (+): is concluded in the case of stains not completely membranous and which do not surround the membranes regardless of quantity in the cells, or weak stains surrounding the entire membrane in less than 10% of the cells. Score 2 (++): is concluded in the presence of a moderate staining surrounding the cytoplasmic membrane in at least 10%, or strong membranous staining in less than 30% of the invasive carcinoma cells. Score 3 (+++): is concluded where IHC yields strong staining surrounding the entire cytoplasmic membrane in at least 30% of the invasive carcinoma cells.|Up to 70 days|FAS population. Here “number of participants analyzed” included evaluable for the outcome measure.||percentage of participants|||Number
635970|NCT02580799|Secondary|Percentage of Participants With Different Hormone Receptors|Presence of hormone receptors was examined by the amount of uptake of estrogen and progesterone hormones when analyzed using IHC staining procedure.|Up to 70 days|FAS population. Here “number of participants analyzed” included evaluable for the outcome measure.||percentage of participants|||Number
636099|NCT02570425|Secondary|Preference of Device Questionnaire 4 Weeks After Baseline Visit Assessed by PASAPQ Part II Q15 Score|Device preference for either Spiromax or Turbohaler device 4 weeks after baseline visit assessed by PASAPQ Part II Q15 score|4 weeks|||percent of participants|||Number
635971|NCT02580799|Secondary|Percentage of Participants With Pathological Grade|Modified Bloom-Richardson Grade scoring system was used which considers the amount of glandular/tubular differentiation, nuclear features and the mitotic activity of tumor cells. Tubular, Nuclear and Mitosis scoring pattern was discussed in outcome 11, each score was added to give a final total score ranging from 3-9. Tumors with 3, 4 or 5 points are classified as being of low malignancy or Grade I, those with 6 or 7 points of intermediate malignancy or Grade II, and those with 8 or 9 points of high malignancy or Grade III.|Up to 70 days|FAS population.||percentage of participants|||Number
635972|NCT02580799|Secondary|Percentage of Participants With Pathological Score|Modified Bloom-Richardson Grade scoring system was used which considers the amount of glandular/tubular differentiation, nuclear features and the mitotic activity of tumor cells. Tubular score (TS) 1: >75 percent (%) of tumor area forming tubular structures, TS 2: 10% to 75% of tumor area forming tubular structures, TS 3: <10% of tumor area forming tubular structures. Nuclear score (NS) 1: nuclei small with little increase in size in comparison with normal breast epithelial cells, regular outlines, uniform nuclear chromatin, little variation in size, NS 2: cells larger than normal with open vesicular nuclei, visible nucleoli, and moderate variability in both size and shape, NS 3: Vesicular nuclei, often with prominent nucleoli, exhibiting marked variation in size and shape, occasionally with very large and bizarre forms. Mitosis score (MS) 1: ≤7 mitoses per 10 high power fields, MS 2: 8-14 mitoses per 10 high power fields and MS 3: ≥15 mitoses per 10 high power fields.|Up to 70 days|FAS population.||percentage of participants|||Number
635973|NCT02580799|Secondary|Percentage of Participants With Initial Tumor Node Metastasis (TNM) Stage According to Council Decision|TNM system is based on size of primary tumor (T), amount of spread to lymph nodes (N) and presence of metastasis (M). T1: tumor ≤20 millimeters (mm), T2: tumor >20 mm to ≤50 mm, T3: >50 mm and TX: tumor cannot be assessed. N0: no lymph node metastasis, N1: metastasis to ipsilateral level I, II axillary lymph nodes, N2: N1 metastasis that is clinically fixed/matted or in clinically detected ipsilateral internal mammary nodes, N3: metastases in ipsilateral infraclavicular lymph nodes, with/without level I, II axillary node involvement, or in clinically detected ipsilateral internal mammary lymph nodes and clinically evident level I, II axillary lymph node metastasis; or metastasis in ipsilateral supraclavicular lymph nodes, NX: Regional lymph nodes cannot be assessed. M0: no clinical/radiographic evidence of distant metastasis, M1: distant detectable metastases as determined by clinical and radiographic means and/or histologically proven >0.2 mm, and MX: metastases cannot be assessed.|Up to 70 days|"FAS population. Here “number of participants analyzed” included evaluable for the outcome measure and n included the number of participants evaluable for the specified category."||percentage of participants|||Number
635974|NCT02580799|Secondary|Percentage of Participants With Diagnosis of Primary Tumor|Primary tumor diagnosis was classified into invasive ductal carcinoma, invasive ductal carcinoma + integrin linked kinase (ILK) antibody and mixed (invasive ductal + lobular) and reported.|Up to 70 days|FAS population.||percentage of participants|||Number
635975|NCT02580799|Primary|Kappa Coefficient as a Measure of Agreement Between Site B and Others (Sites C, D and E) Concerning the IHC Test of Breast Tissue Samples|Inter-laboratory variation between the sites was assessed using Kappa test, K values to be interpreted as follows: a) <0: less than chance agreement, b) 0.01-0.20: slight agreement, c) 0.21-0.40: fair agreement, d) 0.41-0.60: moderate agreement, e) 0.61-0.80: substantial agreement, and f) 0.81-0.99: almost perfect agreement.|Up to 70 days|FAS population. Here “number of participants analyzed” included evaluable for the outcome measure.||kappa coefficient|||Number
635976|NCT02580799|Primary|Percentage of Participants With IHC Evaluation Between Sites B and Others (Sites C, D and E)|IHC is a staining process performed on fresh/frozen breast cancer tissue. IHC is used to show whether or not the cancer cells have HER2 and/or hormone receptors on their surface. The IHC test gives a score of 0 to 3+ that measures the amount of HER2 receptor protein on the surface of cells in a breast cancer tissue sample. Score 0: cells free from immune staining, score 1 (+): is concluded in the case of stains not completely membranous and which do not surround the membranes regardless of quantity in the cells, or weak stains surrounding the entire membrane in less than 10% of the cells. Score 2 (++): is concluded in the presence of a moderate staining surrounding the cytoplasmic membrane in at least 10%, or strong membranous staining in less than 30% of the invasive carcinoma cells. Score 3 (+++): is concluded where IHC yields strong staining surrounding the entire cytoplasmic membrane in at least 30% of the invasive carcinoma cells.|Up to 70 days|"FAS population. Here “number of participants analyzed” included evaluable for the outcome measure and n included the number of participants evaluable for the specified category."||percentage of participants|||Number
635977|NCT02580799|Primary|Kappa Coefficient (K) as a Measure of Agreement Between Site A and Others (Sites B, C, D and E) Concerning the IHC Test of Breast Tissue Samples|Inter-laboratory variation between the sites was assessed using Kappa test, K values were interpreted as follows: a) less than (<) 0: less than chance agreement, b) 0.01-0.20: slight agreement, c) 0.21-0.40: fair agreement, d) 0.41-0.60: moderate agreement, e) 0.61-0.80: substantial agreement, and f) 0.81-0.99: almost perfect agreement.|Up to 70 days|FAS population. Here “number of participants analyzed” included evaluable for the outcome measure.||kappa coefficient|||Number
635978|NCT02580799|Primary|Percentage of Participants With Immunohistochemical (IHC) Evaluation Between Site A and Others (Sites B, C, D and E)|IHC is a staining process performed on fresh/frozen breast cancer tissue. IHC is used to show whether or not the cancer cells have Human Epidermal Growth Receptor (HER2) and/or hormone receptors on their surface. The IHC test gives a score of 0 to 3+ that measures the amount of HER2 receptor protein on the surface of cells in a breast cancer tissue sample. Score 0: cells free from immune staining, score 1 (+): is concluded in the case of stains not completely membranous and which do not surround the membranes regardless of quantity in the cells, or weak stains surrounding the entire membrane in less than 10% of the cells. Score 2 (++): is concluded in the presence of a moderate staining surrounding the cytoplasmic membrane in at least 10%, or strong membranous staining in less than 30% of the invasive carcinoma cells. Score 3 (+++): is concluded where IHC yields strong staining surrounding the entire cytoplasmic membrane in at least 30% of the invasive carcinoma cells.|Up to 70 days|"FAS population. Here “number of participants analyzed” included evaluable for the outcome measure and n included the number of participants evaluable for the specified category."||percentage of participants|||Number
636100|NCT02570425|Secondary|Preference of Participant Device Questionnaire Assessed by PASAPQ Part II Q15 Score|Device preference for either Spiromax or Turbohaler device at baseline assessed by PASAPQ Part II Q15 score|0 weeks (Visit 1)|||percent of participants|||Number
635979|NCT02580357|Other Pre-specified|Tissue Thickness|Through four fixed points marked 5 and 7 mm from the gingival margin in the operated region, tissue thickness of palatine masticatory mucosa. One stent was made to standardize the points to be measured. The stent was positioned, and with a periodontal probe and the points were marked. Then the stent was removed and measurements were taken. For this, an endodontic spacer with a rubber cursor was put on the marked points for it to reach the palatine bone plate. Then the cursor was taken to the tissue carefully to not pressuring it. The distance between the spacer tip and the cursor was measured using a digital pachymeter and measured in millimeters (mm).|Before the procedure and 3 months after the procedure||||||
635980|NCT02580357|Secondary|Postoperative Discomfort|"After air jet application, patients were requested to score postoperative discomfort through on a visual analogue scale (VAS) of 10 centimeters, in which 0 meant no pain and 10 meant extreme pain. After this, a postoperative discomfort average for all groups was obtained."|7, 14, 45, and 60 days after surgical procedure|||units on a scale||Standard Deviation|Mean
635981|NCT02580357|Primary|Change in the Remaining Wound Area (RWA)|For this, standardized photographs were taken (brightness, distance and angle). A scale was used as a reference to measure this area. These photographs were exported to image software ( Image J - NIH, Bethesda, USA) and remaining wound area was measured in square millimeters (mm²).|7,14, 45 and 60 post operative days|||Square millimeters|Photographs|Standard Deviation|Mean
635982|NCT02580318|Primary|Percent Alcohol Concentration Measured by Breathalyzer||20 minutes|number of participants that completed breath alcohol content are reported.||percent Breathalyzed alcohol content||Standard Deviation|Mean
635983|NCT02580240|Secondary|All Cause Mortality|Death from any cause at 90 days after the onset of septic shock|90 days|||Participants|||Count of Participants
635984|NCT02580240|Primary|28-day Mortality|Death from any cause at 28 days after the onset of septic shock|28 days|||Participants|||Count of Participants
635985|NCT02578992|Secondary|Visual Analog Scale of Sore Throat|"All patients were asked to rate the degree of sore throat, using a visual analogue scale after anesthesia emergence in the post-anesthesia care unit.
Scale range: 0-10. 0 is considered to be a better outcome while 10 is a worse outcome."|after anesthesia emergence 30 minutest, at post-anesthesia care unit|||units on a scale||Full Range|Mean
635986|NCT02578992|Secondary|Mean Arterial Pressure|compare the mean arterial pressure between two groups.|before and after intubation, up to 5 minutes|||mmHg||Standard Deviation|Mean
635987|NCT02578992|Secondary|Modified Cormack–Lehane Grade|"The laryngeal view was graded by the observer with modified Cormack-Lehane grade after epiglottis was identified on the video monitor.
Scale range (1, 2, 3, 4). Grade 1 is considered to be a better outcome while grade 4 is considered to be a worse outcome."|during intubation, after epiglottis was identified on the video monitor|||units on a scale||Full Range|Mean
635988|NCT02578992|Primary|Intubation Time|the interval from the intubating stylet touched the mouth to capnogram shown, with all attempts, and was recorded by an independent observer with a stop watch.|from the intubating stylet touched the mouth to the capnogram shown, up to 30 seconds, and the sum of all attempts|||seconds||Inter-Quartile Range|Median
635989|NCT02578316|Secondary|Objective Tumor Response|A response of complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD) was assigned by the investigator as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. CR was defined as disappearance of all target lesions. Any pathological lymph node had to be reduced in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter. PD was defined as a 20% or greater increase in the sum of the longest diameter of measured lesions, taking as reference the smallest sum longest diameter recorded since treatment start or the appearance of one or more new lesions. CR or PR was confirmed no less than 4 weeks after first observation of the response. For SD, measurements must have met the SD criteria at least once after study entry at a minimum interval of 6 weeks. SD is defined as lasting at least 5 weeks.|Baseline to first date of documented CR, PR, SD, or PD, assessed up to 1 year|The Response Evaluable Population is the group of participants who received at least a partial dose of study treatment who had measureable disease per RECIST at baseline.||Percentage of participants|||Number
635990|NCT02578316|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Safety was assessed by monitoring and recording all AEs including all Common Terminology Criteria for Adverse Events (CTCAE) grades (for both increasing and decreasing severity) and SAEs; regular monitoring of hematology, blood chemistry, and urine values; results of physical examinations, regular measurement of vital sign measurements, and 12-lead electrocardiogram (ECG), as detailed in the Schedule of Visits and Procedures. The relationship of AEs to treatment was based on investigator judgment. Details of AEs and SAEs are provided in the reported adverse event section.|Date of first dose of study treatment till 30 days after the last dose, assessed up to 1 year|The Safety Analysis Set was the group of participants who received at least one partial dose of study drug and had at least one postdose safety assessment.||Percentage of participants|||Number
635991|NCT02578316|Primary|Percentage Recovery of 14^C- Lenvatinib Related Material in the Feces|Fecal samples were collected at specific time points, then analyzed for the amount of 14^C- lenvatinib related material. The percentage of the 14^C- lenvatinib dose excreted in feces (Aefeces%) was calculated from time of dosing to the last quantifiable measurement. If radioactivity levels were still present at the end of the Study Phase, sampling continued until each sample contained less than 1% of the total radioactive dose. Percentage recovery of 14^C- lenvatinib related material in the feces was summarized as the Geometric Mean (CV%) percent cumulative for all participants and expressed as percent of 14^C- lenvatinib.|Day 1 to Day 8|PK Analysis Set||Percentage of 14^C-lenvatinib||Geometric Coefficient of Variation|Geometric Mean
635992|NCT02578316|Primary|Percentage Recovery of 14^C- Lenvatinib Related Material in the Urine|Urine samples were collected at specific time points, then analyzed for the amount of 14^C- lenvatinib related material. The total radioactive dose of 14^C-lenvatinib excreted in urine (Aeurine%) was calculated from the time of dosing to the last quantifiable measurement. If radioactivity levels were still present at the end of the Study Phase, sampling continued until each sample contained less than 1% of the total radioactive dose. Percentage recovery of 14^C- lenvatinib related material in the urine was summarized as the Geometric Mean (CV%) percent cumulative for all participants and expressed as percent of 14^C- lenvatinib.|Pre-dose, post-dose at 0-6, 6-12, 12-18, 18-24, 24-30, 30-36, 36-42, 42-48, 48-72, 72-96, 96-120, 120-144, and 144-168 hours|PK Analysis Set||Percentage of 14^C-lenvatinib||Geometric Coefficient of Variation|Geometric Mean
635993|NCT02578316|Primary|Renal Clearance of Lenvatinib (CLr)|CLr was determined based on the interval amount and cumulative amount of the analyte excreted in the urine divided by its corresponding AUC over the same collection interval. Aeurine(0-t)/AUC(0-t), where t is the last measurable concentration, was calculated for lenvatinib only and was summarized as the Geometric Mean (CV%) for all participants and expressed in L/hr.|Pre-dose, post-dose at 0-6, 6-12, 12-18, 18-24, 24-30, 30-36, 36-42, 42-48, 48-72, 72-96, 96-120, 120-144, and 144-168 hours|PK Analysis Set||L/hour||Geometric Coefficient of Variation|Geometric Mean
635994|NCT02578316|Primary|Apparent Terminal Volume of Distribution in the Terminal Phase of Lenvatinib (Vz/F)|Blood samples were drawn at specific time points then analyzed for the amount of 14^C-lenvatinib and non-radiolabeled lenvatinib in the plasma. Vz/F for lenvatinib only was calculated as Dose/[(λz)·(AUC(0-inf))] and was summarized as the Geometric Mean (CV%) for all participants and expressed in liters (L).|Day 1 (pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, 8 and 12 hours), Day 2 (24 hours), Day 3 (48 hours), Day 4 (72 hours), Day 5 (96 hours), Day 6 (120 hours), Day 7 (144 hours) and Day 8 (168 hours)|PK Analysis Set||L||Geometric Coefficient of Variation|Geometric Mean
635995|NCT02578316|Primary|Apparent Clearance (CL/F) of Lenvatinib From Plasma|Blood samples were drawn at specific time points then analyzed for the amount of 14^C-lenvatinib and non-radiolabeled lenvatinib in the plasma. The CL/F for parent lenvatinib only was calculated as Dose/[AUC(0-inf)] and was summarized as the Geometric Mean (CV%) for all participants and expressed in L/hr.|Day 1 (pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, 8 and 12 hours), Day 2 (24 hours), Day 3 (48 hours), Day 4 (72 hours), Day 5 (96 hours), Day 6 (120 hours), Day 7 (144 hours) and Day 8 (168 hours)|PK Analysis Set||L/hour||Geometric Coefficient of Variation|Geometric Mean
635996|NCT02578316|Primary|Percentage of Area Under the Plasma Concentration Curve Extrapolated to Infinity (%AUC(Extra))|Blood samples were drawn at specific time points then analyzed for the amount of 14^C-lenvatinib and non-radiolabeled lenvatinib in the plasma. %AUC(extra) was calculated as [(AUC(0-inf) - AUC(0-t)/AUC(0-inf) ]*100 and was summarized as the Geometric Mean (CV%) for all participants and expressed in (ng·hr/mL).|Day 1 (pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, 8 and 12 hours), Day 2 (24 hours), Day 3 (48 hours), Day 4 (72 hours), Day 5 (96 hours), Day 6 (120 hours), Day 7 (144 hours) and Day 8 (168 hours)|PK Analysis Set||Percent lenvatinib||Geometric Coefficient of Variation|Geometric Mean
635997|NCT02578316|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC(0-inf))|Blood samples were drawn at specific time points then analyzed for the amount of 14^C-lenvatinib and non-radiolabeled lenvatinib in the plasma. The AUC(0-inf) was calculated as AUC(0-t) + Ct/λz where Ct is the last measurable concentration and was summarized as the Geometric Mean (CV%) for all participants and expressed in ng·hr/mL.|Day 1 (pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, 8 and 12 hours), Day 2 (24 hours), Day 3 (48 hours), Day 4 (72 hours), Day 5 (96 hours), Day 6 (120 hours), Day 7 (144 hours) and Day 8 (168 hours)|PK Analysis Set||ng·hr/mL||Geometric Coefficient of Variation|Geometric Mean
635998|NCT02578316|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to Time t (AUC(0-t))|Blood samples were drawn at specific time points then analyzed for the amount of 14^C-lenvatinib and non-radiolabeled lenvatinib in the plasma. The AUC(0-t) was calculated by the combination of linear/log (from Tmax) trapezoidal rule where 't' is the time of last quantifiable plasma concentration following dosing. AUC(0-t) was summarized as the Geometric Mean (CV%) for all participants and expressed in nanograms·hour/milliliter (ng·hr/mL).|Day 1 (pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, 8 and 12 hours), Day 2 (24 hours), Day 3 (48 hours), Day 4 (72 hours), Day 5 (96 hours), Day 6 (120 hours), Day 7 (144 hours) and Day 8 (168 hours)|PK Analysis Set||ng·hr/mL||Geometric Coefficient of Variation|Geometric Mean
635999|NCT02578316|Primary|Terminal Exponential Half-life (t1/2) of Radiolabeled 14^C-Lenvatinib and Non-Radiolabeled Lenvatinib in Plasma|Blood samples were drawn at specific time points then analyzed for the amount of 14^C-lenvatinib and non-radiolabeled lenvatinib in the plasma. The terminal phase t1/2 is the time required to divide the plasma concentration of study drug by two after reaching pseudo-equilibrium, and not the time required to eliminate half of the administered dose of study drug. The t1/2 during the apparent terminal disposition phase was calculated at 0.693/λz and was summarized as the Geometric Mean (CV%) for all participants and expressed as hours.|Day 1 (pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, 8 and 12 hours), Day 2 (24 hours), Day 3 (48 hours), Day 4 (72 hours), Day 5 (96 hours), Day 6 (120 hours), Day 7 (144 hours) and Day 8 (168 hours)|PK Analysis Set||Hours||Geometric Coefficient of Variation|Geometric Mean
636000|NCT02578316|Primary|Terminal Phase Rate Constant (λz) of Radiolabeled 14^C-Lenvatinib and Non-Radiolabeled Lenvatinib in Plasma|Blood samples were drawn at specific time points then analyzed for the amount of 14^C-lenvatinib and non-radiolabeled lenvatinib in the plasma. The terminal phase rate constant represents the rate at which study drug was eliminated from the body and was determined by log-linear regression of the plasma concentrations against time in the terminal phase and was summarized as the Geometric Mean (CV%) for all participants and expressed as 1/hours.|Day 1 (pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, 8 and 12 hours), Day 2 (24 hours), Day 3 (48 hours), Day 4 (72 hours), Day 5 (96 hours), Day 6 (120 hours), Day 7 (144 hours) and Day 8 (168 hours)|PK Analysis Set||1/hour||Geometric Coefficient of Variation|Geometric Mean
636001|NCT02578316|Primary|Time of Maximum Plasma Concentration (Tmax) of Radiolabeled 14^C-Lenvatinib and Non-Radiolabeled Lenvatinib|Blood samples were drawn at specific time points then analyzed for the amount of 14^C-lenvatinib and non-radiolabeled lenvatinib in the plasma. Individual blood/plasma concentration-time data were analyzed using 'non-compartmental' analysis. Tmax was determined from visual inspection of the individual blood/plasma concentration-time profile and was summarized as the Geometric Mean (CV%) for all participants and expressed as hours.|Day 1 (pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, 8 and 12 hours), Day 2 (24 hours), Day 3 (48 hours), Day 4 (72 hours), Day 5 (96 hours), Day 6 (120 hours), Day 7 (144 hours) and Day 8 (168 hours)|PK Analysis Set||Hours||Geometric Coefficient of Variation|Geometric Mean
636028|NCT02576639|Secondary|Summary of Plasma PK Parameter: Tlag|Tlag = time delay between drug administration and first observed concentration above the lower limit of quantification (LOQ) in plasma . Blood samples were collected to assess Tlag.|Days 1 and 91|The PK analysis set was used for the analysis. For a given time point, only those participants from the PK analysis set, who had PK data and had no protocol deviations with relevant impact on PK data, were analyzed for that time point.||hour||Full Range|Median
636101|NCT02570425|Secondary|Type of Participant Handling Errors Recalled by Expert Assessors 8 Weeks After Baseline Visit by All Participants||8 weeks|||errors|||Number
636002|NCT02578316|Primary|Maximum Plasma Concentration (Cmax) of Radiolabeled 14^C-Lenvatinib and Non-Radiolabeled Lenvatinib|Blood samples were drawn at specific time points then analyzed for the amount of 14^C-lenvatinib and non-radiolabeled lenvatinib in the plasma. Individual blood/plasma concentration-time data were analyzed using 'non-compartmental' analysis. Cmax was determined from visual inspection of the individual blood/plasma concentration-time profile and was summarized as the Geometric Mean and percent coefficient of variation for the Geometric Mean (CV%) for all participants and expressed as nanograms/milliliter (ng/mL).|Day 1 (pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, 8 and 12 hours), Day 2 (24 hours), Day 3 (48 hours), Day 4 (72 hours), Day 5 (96 hours), Day 6 (120 hours), Day 7 (144 hours) and Day 8 (168 hours)|The Pharmacokinetic (PK) Analysis Set is the group of participants who received the Study Phase dose of 14^C-lenvatinib and have any evaluable post 14^C- lenvatinib dose plasma and/or blood concentration data.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
636003|NCT02578199|Secondary|Body Weight in Pounds|Body weight in pounds measured 6 months after starting treatment (3 month follow-up after active treatment ends).|6 months|||pounds||Standard Deviation|Mean
636004|NCT02578199|Primary|Body Weight in Pounds|Body weight in pounds measured 3 months after starting treatment.|3 months|27 participants completed treatment, 28 participants completed the post treatment assessment (i.e., one participant who dropped from treatment completed the post treatment assessment).||pounds||Standard Deviation|Mean
636005|NCT02578186|Primary|Mean Latency to Persistent Sleep|Per Protocol population based on subjects who completed treatment crossover|4 weeks|Subjects with evaluable data for mean latency to persistent sleep for both treatment periods were included in the efficacy analysis provided they meet the other defined Per Protocol criteria. All data for each treatment and endpoint were averaged for all days in which the study medication was taken in a given treatment period.||minutes||Standard Error|Mean
636006|NCT02577510|Secondary|Pain With Procedure|visual analogue scale- 0-10 - 0 is equal to no pain, while 10 is equal to maximum pain|less than 30 minutes|||units on a scale|sides|Standard Deviation|Mean
636007|NCT02577510|Secondary|Needle Pass|how often needle changes angle to make target|less than 30 minutes|||attempts|sides|Standard Deviation|Mean
636008|NCT02577510|Secondary|Success Rate|percentage of patients with successful block|less than 30 minutes|||Participants|||Count of Participants
636009|NCT02577510|Primary|Anesthesia Related Time|The main outcome will be the total anesthesia-related time, defined as the sum of performance and onset times|less than 30 minutes|||seconds|sides|Standard Deviation|Mean
636010|NCT02577445|Other Pre-specified|Collect Clinical Characteristics and Symptoms of Patients With Central Sleep Apnea|Characterstics and symptoms of patients screened for sleep disordered breathing were not collected and analyzed.|screening||||||
636011|NCT02577445|Secondary|Incidence of All Cause Mortality and Hospitalizations up to 2 Years After Diagnosis of Central Sleep Apnea|Collect site reported safety data on all patients diagnosed with central sleep apnea and not treated with the remede system|Up to 2 years (collected until 6M FU)|No conclusion can be drawn on all-cause mortality and all-cause hospitalization rates for this group of patients;only 3 subjects diagnosed with CSA (not implanted) reached the 6M FU at the time of study termination. No deaths and/or hospitalizations had been reported in this subject group at the time of study termination.No 12M data is available.||Participants|||Count of Participants
636012|NCT02577445|Secondary|Change in Reverse Remodelling Response as Assessed by Echo Compared to Baseline|Evaluate reverse remodeling response in patients with reduced ejection fraction at baseline|12 months post implant|No data available; no patient had completed a 12 months echo prior to the premature study stop|||||
636013|NCT02577445|Secondary|Impact on Quality of Life Compared to Baseline|Evaluate impact on Quality of Life by using a general questionnaire, a sleep-specific questionnaire and a questionnaire specific for heart failure patients|Up to 5 years post-implant|No data available on Quality of Life questionnaires; no patient completed the questionnaires at baseline AND at the 12M/24M follow-up at the time of premature study stop.|||||
636014|NCT02577445|Secondary|Change in Apnea-hypopnea Index as Assessed by Polygraphy Compared to Baseline|Evaluate changes in sleep study results at 12 months compared to baseline|12 months post-implant|A complete dataset is only available for 1 patient and due to confidentiality reasons for this 1 patient we prefer not to present this data.|||||
636015|NCT02577445|Primary|Incidence of All Cause Mortality, SAEs, Stimulation Complaints, Device and/or Cardiovascular Related Events From Implant up to 5 Years.|"Collect short and long term clinical data on safety of the remede system implanted in daily practice.
This outcome measure was intended to be collected up to 5 years, but at time of early study termination the data were only monitored until 24 months for 1 patient."|From implant up to 5 years (collected until 24 month FU)|Viewing the limited amount of data at early study termination, the data should be interpreted with caution.||Participants|||Count of Participants
636016|NCT02577315|Secondary|Area Under the Concentration-time Curve of the Metformin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity)|Area under the concentration-time curve of the Metformin in plasma over the time interval from 0 extrapolated to infinity (AUC 0-infinity observed). Geometric means (gMeans) represent adjusted gMeans and geometric coefficient of variation (gCV) reflects the intra-individual gCV (%) from the mixed model analysis.|PK plasma samples were taken at: 2 hours (h) before drug administration and 20 minutes, 40 minutes, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration.|Pharmacokinetic analysis set (PKS): all subjects from the TS who provided at least 1 primary or secondary Pharmacokinetic (PK) endpoint value that was judged as PK evaluable and was not affected by protocol violations relevant to the statistical evaluation. Thus, subject was included, even if he/she contributed only 1 PK value for one period.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
636029|NCT02576639|Secondary|Summary of Plasma PK Parameter: Tmax|Tmax = the time to reach the maximum concentration after drug administration. Blood samples were collected to assess Tmax.|Days 1 and 91|The PK analysis set was used for the analysis. For a given time point, only those participants from the PK analysis set, who had PK data and had no protocol deviations with relevant impact on PK data, were analyzed for that time point.||hour||Full Range|Median
636102|NCT02570425|Secondary|Type of Participant Handling Errors by Expert Assessors 4 Weeks After Baseline Visit by All Participants||4 weeks|||errors|||Number
636103|NCT02570425|Secondary|Type of Participant Handling Errors Recalled by Expert Assessors at Baseline Visit by All Participants||0 weeks (Visit 1)|||errors|||Number
636017|NCT02577315|Secondary|Area Under the Concentration-time Curve of the Empagliflozin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity)|Area under the concentration-time curve of the Empagliflozin in plasma over the time interval from 0 extrapolated to infinity (AUC 0-infinity observed). Geometric means (gMeans) represent adjusted gMeans and geometric coefficient of variation (gCV) reflects the intra-individual gCV (%) from the mixed model analysis.|PK plasma samples were taken at: 2 hours (h) before drug administration and 20 minutes, 40 minutes, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration.|Pharmacokinetic analysis set (PKS): all subjects from the TS who provided at least 1 primary or secondary Pharmacokinetic (PK) endpoint value that was judged as PK evaluable and was not affected by protocol violations relevant to the statistical evaluation. Thus, subject was included, even if he/she contributed only 1 PK value for one period.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
636018|NCT02577315|Primary|Maximum Measured Concentration of the Metformin in Plasma (Cmax)|Maximum measured concentration of the Metformin in plasma (Cmax). Geometric means (gMeans) represent adjusted gMeans and geometric coefficient of variation (gCV) reflects the intra-individual gCV (%) from the mixed model analysis.|PK plasma samples were taken at: 2 hours (h) before drug administration and 20 minutes, 40 minutes, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration.|Pharmacokinetic analysis set (PKS): all subjects from the TS who provided at least 1 primary or secondary Pharmacokinetic (PK) endpoint value that was judged as PK evaluable and was not affected by protocol violations relevant to the statistical evaluation. Thus, subject was included, even if he/she contributed only 1 PK value for one period.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
636019|NCT02577315|Primary|Maximum Measured Concentration of the Empagliflozin in Plasma (Cmax)|Maximum measured concentration of the Empagliflozin in plasma (Cmax). Geometric means (gMeans) represent adjusted gMeans and geometric coefficient of variation (gCV) reflects the intra-individual gCV (%) from the mixed model analysis.|PK plasma samples were taken at: 2 hours (h) before drug administration and 20 minutes, 40 minutes, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration.|Pharmacokinetic analysis set (PKS): all subjects from the TS who provided at least 1 primary or secondary Pharmacokinetic (PK) endpoint value that was judged as PK evaluable and was not affected by protocol violations relevant to the statistical evaluation. Thus, subject was included, even if he/she contributed only 1 PK value for one period.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
636020|NCT02577315|Primary|Area Under the Concentration-time Curve of the Metformin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)|Area under the concentration-time curve of the Metformin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). Geometric means (gMeans) represent adjusted gMeans and geometric coefficient of variation (gCV) reflects the intra-individual gCV (%) from the mixed model analysis.|PK plasma samples were taken at: 2 hours (h) before drug administration and 20 minutes, 40 minutes, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration.|Pharmacokinetic analysis set (PKS): all subjects from the TS who provided at least 1 primary or secondary Pharmacokinetic (PK) endpoint value that was judged as PK evaluable and was not affected by protocol violations relevant to the statistical evaluation. Thus, subject was included, even if he/she contributed only 1 PK value for one period.||nanogram (ng)*h /millilitre (mL)||Geometric Coefficient of Variation|Geometric Mean
636021|NCT02577315|Primary|Area Under the Concentration-time Curve of the Empagliflozin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)|Area under the concentration-time curve of the Empagliflozin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). Geometric means (gMeans) represent adjusted gMeans and geometric coefficient of variation (gCV) reflects the intra-individual gCV (%) from the mixed model analysis.|PK plasma samples were taken at: 2 hours (h) before drug administration and 20 minutes, 40 minutes, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration.|Pharmacokinetic analysis set (PKS): all subjects from treated set (TS) who provided at least 1 primary or secondary Pharmacokinetic (PK) endpoint value that was judged as PK evaluable and was not affected by protocol violations relevant to the statistical evaluation. Subject was included, even if he/she contributed only 1 PK value for one period.||nanomol (nmol)* hours (h) / Litre (L)||Geometric Coefficient of Variation|Geometric Mean
636022|NCT02576639|Secondary|Apparent Volume of Distribution (Vz/F)||Day 91|This PK parameter was not analyzed because data was not collected.|||||
636023|NCT02576639|Secondary|Area-under-plasma Concentration Time Curve up to Infinity (AUCinf)|CNP520 concentrations in plasma|Day 91|This PK parameter was not analyzed because data was not collected.|||||
636024|NCT02576639|Secondary|Summary of CSF PK Concentrations|CSF samples were collected by lumbar puncture for assessment.|Days 1, 14, 28, 42, 56, 70 and 91|The PK analysis set was used for the analysis. For a given time point, only those participants from the PK analysis set, who had PK data and had no protocol deviations with relevant impact on PK data, were analyzed for that time point.||ng/mL||Standard Deviation|Mean
636025|NCT02576639|Secondary|Summary of Plasma PK Parameter: Racc|Racc = the accumulation ratio . Blood samples were collected to assess Racc.|Day 91|The PK analysis set was used for the analysis. Only those participants from the PK analysis set, who had PK data and had no protocol deviations with relevant impact on PK data, were analyzed.||ratio||Standard Deviation|Mean
636026|NCT02576639|Secondary|Summary of PK Parameter: CLss/F|CLss/F = the apparent systemic clearance from plasma observed during a dosing interval at steady state following extravascular administration. Blood samples were collected to assess CLss/F.|Day 91|The PK analysis set was used for the analysis. Only those participants from the PK analysis set, who had PK data and had no protocol deviations with relevant impact on PK data, were analyzed.||mL/h||Standard Deviation|Mean
636027|NCT02576639|Secondary|Summary of Plasma PK Parameter: T1/2|T1/2 = the terminal elimination half-life. Blood samples were collected to assess T/12.|Day 91|The PK analysis set was used for the analysis. Only those participants from the PK analysis set, who had PK data and had no protocol deviations with relevant impact on PK data, were analyzed.||hour||Standard Deviation|Mean
636104|NCT02570425|Secondary|Number of Assessor-observed Errors Recalled 8 Weeks After Baseline Visit by All Participants|Quantity of errors made at each level recalled by expert assessors at 8 weeks after baseline visit by all participants|8 weeks|||errors|||Number
637217|NCT02500368|Secondary|Bulbar Hyperemia|Bulbar hyperemia assessed using scale 0-4, 0.5 steps, 0=No hyperemia, 4=Severe hyperemia.|Baseline and 1 week|||units on a scale||Standard Deviation|Mean
636030|NCT02576639|Secondary|Summary of Plasma PK Parameter: AUCtau|AUCtau = the area under the plasma concentration-time curve from zero to the end of the dosing interval tau. Blood samples were collected to assess AUCtau.|Days 1 and 91|The PK analysis set was used for the analysis. For a given time point, only those participants from the PK analysis set, who had PK data and had no protocol deviations with relevant impact on PK data, were analyzed for that time point.||h*ng/mL||Standard Deviation|Mean
636031|NCT02576639|Secondary|Summary of Plasma PK Parameter: Cmax|Cmax = the observed maximum plasma concentration following drug administration. Blood samples were collected to assess Cmax. The PK analysis set was used for the analysis.|Days 1, 91|The PK analysis set was used for the analysis. For a given time point, only those participants from the PK analysis set, who had PK data and had no protocol deviations with relevant impact on PK data, were analyzed for that time point.||ng/mL||Standard Deviation|Mean
636032|NCT02576639|Secondary|Change From Baseline of Amyloid Beta (Aβ) 1-38 , Aβ 1-40 and Aβ 1-42 Cerebrospinal Fluid (CSF) Concentrations|CSF samples were collected by lumbar puncture for assessment.|Day 92|The pharmacodynamics (PD) analysis set was analyzed. The PD set included only randomized participants who had available PD data and no protocol deviations with relevant impact on PD data.||Percentage change||Standard Deviation|Mean
636033|NCT02576639|Primary|Number of Subjects With Non-serious and Serious Adverse Events (AEs) and Deaths|Safety monitoring was conducted throughout the study.|13 weeks|The safety analysis set, which included participants who received at least 1 dose of study drug (CNP520 or placebo), was analyzed.||Participants|||Number
636034|NCT02576535|Post-Hoc|Number of Participants Experiencing Seizures||10 years|||participants|||Number
636035|NCT02576535|Primary|Number of Participants With Complete Occlusion of AVM on Serial MRI Confirmed With Angiography||10 years|||participants|||Number
636036|NCT02576535|Primary|Number of Participants Experiencing Hemorrhage From the Arteriovenous Malformation (AVM)||10 years|||participants|||Number
636037|NCT02576535|Primary|Number of Participants With Presence of New Neurological Symptoms Without Evidence of MRI Abnormalities||10 years|||participants|||Number
636038|NCT02576535|Primary|Number of Participants With Presence of T2 Weighted Changes on Serial MRI Exam Associated With New Neurological Symptoms||10 years|||participants|||Number
636039|NCT02576535|Secondary|Number of Participants With Presence of T2 Weighted Changes on Serial MRI Exam Not Associated With Neurological Symptoms||10 years|||participants|||Number
636040|NCT02576249|Secondary|Tegner Activity Level Scale|"The Tegner activity level scale is a scale that aims to provide a standardized method of grading work and sporting activities. The Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The patient is asked to select the level of participation that best describes their current level of activity and that before injury.
A score of 0 represents sick leave or disability pension because of knee problems, whereas a score of 10 corresponds to participation in national and international elite competitive sports. A score >6 can only be achieved if the person participates in recreational or competitive sport."|baseline (pre-injection), 2 weeks, 3 months|||units on a scale||Standard Deviation|Mean
636041|NCT02576249|Secondary|Pain Scale Score|Pain was measured by a Visual Analog Scale (VAS) marked from 0 (no pain) to 10 (unbearable pain) at rest and with activity. It was collected at baseline (pre-injection), immediately post-injection on the day of surgery, and at 2 weeks and 3 months.|Pre-injection, immediately post-injection, 2 weeks, 3 months|||units on a scale||Standard Deviation|Mean
636042|NCT02576249|Primary|The Knee Osteoarthritis Outcome Score (KOOS) Pain Subscale|The KOOS holds 42 items in five separately scored subscales: Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0–100 scale, with zero representing extreme knee problems and 100 representing no knee problems.|3 months after the injection|||units on a scale||Standard Deviation|Mean
636043|NCT02576145|Secondary|Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes|Up to Month 12|All patient population: All participants who were enrolled in the study and received at least 1 vaccine dose were included in this population.||participants|||Number
636044|NCT02576145|Secondary|Number of Participants With a Positive Delayed Type Hypersensitivity (DTH) Response After KLH Immunization|DTH skin reactions were assessed 48 hours after each KLH immunization given on Day 1 and on Day 29. A positive response was defined as an induration >=5 mm.|Day 1 and Day 29|All patient population: All participants who were enrolled in the study and received at least 1 vaccine dose were included in this population.||participants|||Number
636045|NCT02576145|Secondary|Number of KLH Antibody Nonresponders Who Underwent Rechallenge and Mounted a KLH Antibody Response|Nonresponders (participants who failed to mount antibody responses to KLH) were rechallenged with KLH 6 months after Day 29 (Day 196). For nonresponders, positive antibody response to KLH was defined as at least a 2-fold increase in antibody concentration at any time point up to Day 252 compared with baseline where baseline was assigned a value of 1 if it was below the limit of quantification. All humoral responses were assessed by enzyme-linked immunosorbent assay (ELISA).|Up to Day 252|All patient population: All participants who were enrolled in the study and received at least 2 vaccine doses were included in this population. Only participants who were KLH Antibody nonresponders were evaluated.||participants|||Number
636046|NCT02576145|Secondary|Percentage of Participants With Positive Antibody Response to KLH Immunization at Month 6|Positive antibody response was defined as at least a 2-fold increase in antibody concentration on Month 6 compared with baseline where baseline was assigned a value of 1 if it was below the limit of quantification. All humoral responses were assessed by enzyme-linked immunosorbent assay (ELISA). Due to the small number of participants enrolled in the study, percentage of participants with positive antibody response to KLH immunization at Month 6 was not reported.|Month 6||||||
636047|NCT02576145|Secondary|Mean Percent Expression of HLA-DR+, CD45RO+ and CD45RA+|Blood samples were obtained for flow activated cell sorter (FACS) analyses of HLA-DR+, CD45RO+ and CD45RA+ on Days 1, 29, and 57. These cells are present on white blood cells and are used as markers to associate cells with immune functions.|Days 1, 29 and 57|All patient population: All participants who were enrolled in the study and received at least 1 vaccine dose were included in this population.Only participants with data available at a particular time point were analyzed.||Percent expression||Standard Deviation|Mean
636048|NCT02576145|Secondary|Mean Percent Expression of CD3, CD4, and CD8|Blood samples were obtained for flow activated cell sorter (FACS) analyses of T cell subsets (CD3, CD4, and CD8) on Days 1, 22, 29, 43, and 57. These cells are present on white blood cells and are used as markers to associate cells with immune functions.|Days 1, 22, 29, 43 and 57|All patient population: All participants who were enrolled in the study and received at least 1 vaccine dose were included in this population. Only participants with data available at a particular time point were analyzed.||Percent expression||Standard Deviation|Mean
636049|NCT02576145|Secondary|Mean Percent Expression of 2A3/CD25+ Antibody|CD25 is an antigen that is present on a subset of peripheral blood lymphocytes. The expression of CD25+ on T cell was investigated using antibody 2A3. Blood samples were drawn for evaluation of CD25+ at screening and on Days 29, 57, and 168.|Screening, Day 29, Day 57 and Day 168|All patient population: All participants who were enrolled in the study and received at least 1 vaccine dose were included in this population. Only participants with data available at a particular time point were analyzed.||Percent expression||Standard Deviation|Mean
636050|NCT02576145|Secondary|Geometric Mean Antibody Concentrations for KLH (IgM and IgG) and TT (IgG)|Due to the small number of participants enrolled in the study, geometric means at Baseline and on Days 22, 29, 43 and 57 were not reported.|Screening, Day 22, Day 29, Day 43 and Day 57||||||
636051|NCT02576145|Secondary|Number of Tetanus Cellular Nonresponders Who Were Rechallenged and Mounted a Cellular Tetanus Response|Nonresponders (participants who mount humoral responses but no cellular responses to tetanus vaccination) were rechallenged with TT 6 months after Day 29 (Day 196). For nonresponders, positive cellular response to TT was defined as an increase in the BrdU percent total net of at least 1.5-fold compared with baseline, where baseline was assigned a value of 0.5 if <=0, at any time point up to Day 252. All cellular responses were assessed by BrdU proliferation assay.|up to Day 252|All patient population: All participants who were enrolled in the study and received at least 2 vaccine doses were included in this population. Only participants who were tetanus cellular nonresponders were evaluated.||participants|||Number
636052|NCT02576145|Secondary|Number of KLH Cellular Nonresponders Who Were Rechallenged and Mounted a Cellular Response to KLH Immunization|Nonresponders (participants who failed to mount cellular responses to KLH) were rechallenged with KLH 6 months after Day 29 (Day 196). For nonresponders, positive cellular response to KLH was defined as an increase in the 5-bromo-2-deoxyuridine (BrdU) percent total net of at least 1.5-fold compared with baseline, where baseline was assigned a value of 0.5 if <=0, on at least one time point up to Day 252. All cellular responses were assessed by BrdU proliferation assay.|Up to Day 252|All patient population: All participants who were enrolled in the study and received at least 2 vaccine doses were included in this population. Only participants who were KLH cellular nonresponders were evaluated.||participants|||Number
636053|NCT02576145|Secondary|Number of Participants Who Developed a Positive Antibody Response to KLH and Positive Cellular Responses to Both KLH and TT Immunizations|Positive antibody response was defined as at least a 2-fold increase in antibody concentration on either Day 43 or Day 57 compared with baseline where baseline was assigned a value of 1 if it was below the limit of quantification. Positive cellular response was defined as an increase in the 5-bromo-2-deoxyuridine (BrdU) percent total net of at least 1.5-fold compared with baseline, where baseline was assigned a value of 0.5 if <=0, on at least one time point on Days 22, 29, 43 or 57. All humoral responses were assessed by ELISA and all cellular responses were assessed by BrdU proliferation assay.|Baseline, Day 22, Day 29, Day 43 and Day 57|All patient population: All participants who were enrolled in the study and received at least 1 vaccine dose were included in this population.||participants|||Number
636054|NCT02576145|Secondary|Number of Participants Who Developed a Positive Cellular Response to Tetanus Toxoid (TT)|Positive cellular response was defined as an increase in the BrdU percent total net of at least 1.5-fold compared with baseline, where baseline was assigned a value of 0.5 if <=0, on at least one time point on days 22, 29, 43 or 57. All cellular responses were assessed by BrdU proliferation assay.|Baseline, Day 22, Day 29, Day 43 and Day 57|All patient population: All participants who were enrolled in the study and received at least 1 vaccine dose were included in this population.||participants|||Number
636055|NCT02576145|Secondary|Number of Participants Who Developed a Positive Humoral Response to Tetanus Toxoid (TT)|Humoral response to TT was defined as >=1.5 fold increase in antibody concentration from baseline in participants with protective anti-TT IgG level >=0.1 IU/mL. All humoral responses were assessed by ELISA.|Baseline, Day 22, Day 29, Day 43 and Day 57|All patient population: All participants who were enrolled in the study and received at least 1 vaccine dose were included in this population.||participants|||Number
636056|NCT02576145|Secondary|Number of Participants Who Developed Both a Positive Antibody Response and a Positive Cellular Response to KLH Immunization|Positive antibody response was defined as at least a 2-fold increase in antibody concentration on either Day 43 or Day 57 compared with baseline where baseline was assigned a value of 1 if it was below the limit of quantification. Positive cellular response was defined as an increase in the 5-bromo-2-deoxyuridine (BrdU) percent total net of at least 1.5-fold compared with baseline, where baseline was assigned a value of 0.5 if <=0, on at least one time point on Days 22, 29, 43 or 57. All humoral responses were assessed by ELISA and all cellular responses were assessed by BrdU proliferation assay.|Baseline, Day 22, Day 29, Day 43 and Day 57|All patient population: All participants who were enrolled in the study and received at least 1 vaccine dose were included in this population.||participants|||Number
636057|NCT02576145|Secondary|Number of Participants Who Developed a Positive Cellular Response to KLH Immunization|Positive cellular response was defined as an increase in the 5-bromo-2-deoxyuridine (BrdU) percent total net of at least 1.5-fold compared with baseline, where baseline was assigned a value of 0.5 if <=0, on at least one time point on Days 22, 29, 43 or 57. All cellular responses were assessed by BrdU proliferation assay.|Baseline, Day 22, Day 29, Day 43, and Day 57|All patient population: All participants who were enrolled in the study and received at least 1 vaccine dose were included in this population.||participants|||Number
636058|NCT02576145|Primary|Number of Participants Who Developed a Positive Antibody Response (IgG) to Keyhole Limpet Hemocyanin (KLH) Immunization|Positive antibody response was defined as at least a 2-fold increase in antibody concentration on either Day 43 or Day 57 compared with baseline where baseline was assigned a value of 1 if it was below the limit of quantification. All humoral responses were assessed by enzyme-linked immunosorbent assay (ELISA).|Baseline and Day 43 or Day 57|All patient population: All participants who were enrolled in the study and received at least 2 vaccine doses and had Day 43 and 57 assessments were included in this population.||participants|||Number
636059|NCT02576041|Secondary|Time to Reaction Evaluated During the F1 Simulator|During the test, at different times, the patient will be requested (by led enlighten on the dashboard) to execute actions on the steering-wheel. The delay in executing the requested actions will be registered.|7±3 days of active treatment|Adult outpatient of eighter sex affected by Allergic Rhinitis (seasonal or perennial) and/or chronic urticaria (induced or not induced) able to perform a preliminary driving test on F1-high speed simulator without experiencing sign or symptoms of intolerance towards the drive simulation (e.g. nausea, vomiting or dizziness).||msec||Standard Deviation|Mean
636060|NCT02576041|Secondary|Maintenance of Constant Speed Evaluated During the F1 Simulator|Different speed were maintained as requested by the simulator. Variations during the test were recorded. The mean deviation from the requested speed was registered.|7±3 days of active treatment|The study included adult outpatient of either sex,affected by Allergic Rhinitis (seasonal or perennial) and/or Chronic Urticaria (induced or not induced),able to perform a preliminary driving test on F1-high speed simulator without experiencing signs or symptoms of intolerance towards the drive simulation (e.g. nausea, vomiting or dizziness, etc).||Km/h||Standard Deviation|Mean
636061|NCT02576041|Primary|Standard Deviation Lateral Position (SDLP) Evaluated During the F1 Simulator Test|SDLP (mainly assessing attention capacities). This is a measure of weaving and quality in keeping the requested path. The vehicle position was constantly monitored. The deviation from central position was registered.|7+3 days of active treatment|The study included adult outpatient of either sex affected by allergic rhinitis (seasonal or perennial) and/or chronic urticaria (induced or not induced) able to perform a preliminary driving test on F1-high speed simulator without experiencing sign or symptoms of intolerance towards the drive simulation (e.g. nausea, vomiting or dizziness).||meters||Standard Deviation|Mean
636062|NCT02575911|Secondary|Prediction Error Between Target Versus Achieved Refraction at One and Three Months Post-op|Prediction error was summarized as a percentage of eyes within 0.5 D and 1.0 D of target at one and three months postoperative|Month 1, Month 3 postoperative|This analysis population includes the number of eyes treated with surgery and data available at the specified time point.||percentage of eyes|Eyes||Number
636063|NCT02575911|Secondary|Manifest Refraction Spherical Equivalent (MRSE)|The participant was manually refracted to his/her best correction using a phoropter and standard Snellen eye charts. Each eye contributed separately to the analysis.|Baseline, Month 1, Month 3 postoperative|This analysis population includes number of eyes in specified category.||diopter|Eyes|Standard Deviation|Mean
636064|NCT02575911|Secondary|Best Corrected Distance Visual Acuity (BCDVA) by Visit|BCDVA (measurement with the participant's best spectacle correction) was assessed at a distance of 6 meters or 20 feet using a standard Snellen eye chart, both monocularly and binocularly, and reported categorically as a percentage of eyes analyzed.|Baseline, Month 1, Month 3 postoperative|This analysis population includes total number of eyes in specified category at visit.||percentage of eyes|Eyes||Number
636065|NCT02575911|Secondary|Uncorrected Distance Visual Acuity (UCDVA) at Month 1 and Month 3 Postoperative|UCDVA (measurement of uncorrected (without spectacles or other visual corrective devices) distance visual acuity) was assessed at a distance of 6 meters or 20 feet using a standard Snellen eye chart, both monocularly and binocularly, and reported categorically as a percentage of eyes analyzed.|Month 1, Month 3 postoperative|This analysis population includes the number of eyes treated with surgery and data available.||percentage of eyes|Eyes||Number
636066|NCT02575911|Secondary|Opaque Bubble Layer (OBL) at Day 0, Operative Day|Opaque bubble layer was assessed by the investigator during the surgery on a scale from 0 to 5 where 0 = No OBL and 5 = 100% OBL in the stromal bed area. Each eye contributed separately to the analysis.|Day 0, operative day|Safety Analysis Set||units on a scale|Eyes|Standard Deviation|Mean
636067|NCT02575911|Secondary|Stromal Bed Quality at Day 0, Operative Day|Stromal bed quality was assessed by the investigator on a roughness scale from 0 to 5 where 0 = Very rough surface and 5 = Very smooth surface. Each eye contributed separately to the analysis.|Day 0, operative day|Safety Analysis Set||units on a scale|Eyes|Standard Deviation|Mean
636068|NCT02575911|Secondary|Ease of Flap Dissection at Day 0, Operative Day|Ease of flap dissection (ease of lifting the flap during surgery) was assessed on a scale from 0 to 5 where 0 = Unable to lift flap and 5 = Able to lift flap without any resistance using blunt instrument. Each eye contributed separately to the analysis.|Day 0, operative day|Safety Analysis Set||units on a scale|Eyes|Standard Deviation|Mean
636069|NCT02575911|Secondary|Flap Thickness Precision Within the Central Zone at Month 1 and Month 3 Postoperative|Flap thickness was assessed by OCT and averaged from 3 separate scans. Flap thickness precision (variability of the achieved flap thickness) was defined as the standard deviation of the flap thickness measurement. Each eye contributed separately to the analysis.|Month 1, Month 3 postoperative|This analysis population includes the number of eyes treated with surgery and data available.||micrometers|Eyes|Standard Deviation|Mean
636070|NCT02575911|Secondary|Flap Thickness Accuracy Within the Central Zone at Month 1 Postoperative|Flap thickness was assessed by OCT and averaged from 3 separate scans. Flap thickness accuracy was defined as the mean difference between the achieved and desired (desired subtracted from achieved) flap thickness. A positive number represents a postoperative flap thickness that is thicker than the expected flap thickness and vice versa for a negative number. Each eye contributed separately to the analysis.|Month 1 postoperative|This analysis population includes the number of eyes treated with surgery and data available.||micrometers|Eyes|Standard Deviation|Mean
636082|NCT02572609|Primary|AUC0-t|Area under the plasma concentration-time curve, calculated by the trapezoidal methods from time 0 to time t, where t is the time for the last concentration experimentally determined above the Limit of Quantification (LOQ).|0:00h (hours), 0:15h, 0:30h, 0:45h, 1:00h, 1:15h, 1:30h, 1:45h, 2:00h, 2:20h, 2:40, 3:00, 3:30h, 4:00h, 5:00h, 6:00h, 8:00h, 12:00h, 16:00h, 24:00h, 36:00h and 48:00h|PK set||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
649362|NCT02082912|Secondary|Change in Stroke Impact Scale Score||Baseline and at end of 3 weeks of treatment||||||
636071|NCT02575911|Primary|Flap Thickness Accuracy Within the Central Zone at Month 3 Postoperative|Flap thickness was assessed by optical coherence tomography (OCT) and averaged from 3 separate scans. Flap thickness accuracy was defined as the mean difference between the achieved and desired (desired subtracted from achieved) flap thickness. A positive number represents a postoperative flap thickness that is thicker than the expected flap thickness and vice versa for a negative number. Each eye contributed separately to the analysis.|Month 3 postoperative|This analysis population includes the number of eyes treated with surgery and data available.||micrometers|Eyes|Standard Deviation|Mean
636072|NCT02574845|Secondary|Area Under the Curve of Rosuvastatin From 0 Extrapolated to Infinity (AUC0-∞)|This outcome measure presents area under the concentration-time curve of rosuvastatin in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).|Blood sampling within 3 hours (h) prior to the study drug administration, at the time of administration (0:00) and 30 minutes, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11h, 12h, 24h, 34h, and 48h thereafter.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
636073|NCT02574845|Primary|Maximum Concentration of Rosuvastatin (Cmax)|This outcome measure presents the maximum measured concentration of rosuvastatin in plasma (Cmax).|Blood sampling within 3 hours (h) prior to the study drug administration, at the time of administration (0:00) and 30 minutes, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11h, 12h, 24h, 34h, and 48h thereafter.|PKS||nmol/L||Geometric Coefficient of Variation|Geometric Mean
636074|NCT02574845|Primary|Area Under the Curve of Rosuvastatin From 0 to the Last Quantifiable Data Point (AUC0-tz)|This outcome measure presents the area under the concentration-time curve of rosuvastatin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz).|Blood sampling within 3 hours (h) prior to the study drug administration, at the time of administration (0:00) and 30 minutes, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11h, 12h, 24h, 34h, and 48h thereafter.|The pharmacokinetic (PK) parameter set (PKS) includes all randomised subjects who took at least one dose of study medication and provided at least one primary or secondary PK parameter that was not excluded from analysis due to non-evaluability or protocol violation relevant for the evaluation of the pharmacokinetics.||nanomol (nmol) * hour (h) / Litre (L)||Geometric Coefficient of Variation|Geometric Mean
636075|NCT02574260|Secondary|Number of Participants Alive at the Time of Study Discontinuation or Completion||At end of study, median duration of treatment was 267 days|||participants|||Number
636076|NCT02574260|Secondary|Number of Participants With an Objective Response|"Objective response is defined as participants with an overall best response of complete response or partial response. The objective response to treatment was assessed by computed tomography (CT) scanning or other clinical measurement using modified Response Evaluation Criteria In Solid Tumors (RECIST).
Responses must have been confirmed two visits not less than 4 weeks apart.
Tumor burden for a visit was calculated as the sum of the longest diameters of all tumors identified and measured up to that visit. Tumor response at each visit was derived from tumor burden, as follows:
Complete response (CR): zero tumor burden
Partial response (PR): a 30% or greater decrease in tumor burden
Progressive disease (PD): a 20% or greater increase in tumor burden
Stable disease (SD): none of the above (a < 30% decrease and < 20% increase in tumor burden)"|Every 12 weeks from the start of therapy in this extension protocol, or 12 weeks from the last assessment in the 002/03 protocol (whichever date is later) through 30 days after administration of the last dose; median duration of treatment was 267 days.|||participants|||Number
636077|NCT02574260|Primary|Number of Participants With Adverse Events|"The severity of an adverse event (AE) was graded according to Common Toxicity Criteria for Adverse Events (CTCAE) Version 3 (1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death).
Serious adverse events include death, life-threatening events, events requiring or prolonging hospitalization, result in persistent or significant disability/incapacity, or a congenital anomaly/birth defect, or otherwise important medical events that may jeopardise the patient or require intervention to prevent one of the above outcomes."|From the first dose of talimogene laherparepvec in Study 002-03-E and within 30 days of the last dose; median duration of treatment was 267 days.|||participants|||Number
636078|NCT02573870|Primary|Change From Baseline in 0 to 4 Hours Post-dose Weighted Mean Heart Rate at Day 42, Derived From Electrocardiograms (ECGs)|ECG measurements were taken in supine position after obtaining vital signs. Weighted mean was derived by calculating the area under the curve (AUC), and then dividing by the relevant time interval. Baseline was the pre-dose measurement on Day 1. Change from Baseline in 0 to 4 hours post-dose weighted mean heart rate was measured on Days 1, 28 and 42 and was analyzed using a mixed models repeated measures (MMRM) model. Intent-To-Treat (ITT) Population: all randomized participants who received at least one dose of study medication.|Baseline and Day 42|ITT Population||Beats per minute (bpm)||Standard Error|Least Squares Mean
636079|NCT02572752|Secondary|AUC0-inf|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf). The unadjusted geometric mean (gMean) and geometric coefficient variation (gCV) was calculated for Test treatment (T), Reference 1 treatment (R1) and Reference 2 treatment (R2) separately.|-1:00 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 4:30h, 5:00h, 5:30h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration.|PKS||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
636080|NCT02572752|Primary|Cmax|Maximum measured concentration of the analyte in plasma (Cmax). The unadjusted geometric mean (gMean) and geometric coefficient variation (gCV) was calculated for Test treatment (T), Reference 1 treatment (R1) and Reference 2 treatment (R2) separately.|-1:00 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 4:30h, 5:00h, 5:30h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration.|PKS||ng/mL||Geometric Coefficient of Variation|Geometric Mean
636081|NCT02572752|Primary|AUC0-tz|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). The unadjusted geometric mean (gMean) and geometric coefficient variation (gCV) was calculated for Test treatment (T), Reference treatment 1 (R1) and Reference treatment 2 (R2) separately.|-1:00 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 4:30h, 5:00h, 5:30h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration.|Pharmacokinetic Set (PKS) : This analysis set included all treated subjects who provided at least 1 observation for at least 1 primary endpoint, and who had no important protocol violations impacting statistical evaluation of PK endpoints.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
636083|NCT02572609|Primary|Cmax|Maximum plasma concentration achieved|0:00h (hours), 0:15h, 0:30h, 0:45h, 1:00h, 1:15h, 1:30h, 1:45h, 2:00h, 2:20h, 2:40, 3:00, 3:30h, 4:00h, 5:00h, 6:00h, 8:00h, 12:00h, 16:00h, 24:00h, 36:00h and 48:00h|The pharmacokinetic set (PK Set): 36 subjects provided 1 evaluable value of reference product and 1 evaluable value of test product for the primary PK endpoints (Cmax and AUC0-t) without important protocol violations with respect to the statistical evaluation of PK endpoints.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
636084|NCT02572427|Secondary|Knowledge Concerning Intubation of Neonates|Score on cognitive test on intubation of neonates.Scores ranged on scale from 0 to 21 , with higher score indicating greater knowledge (better outcome).|30 minutes|||scores on a scale||Standard Deviation|Mean
636085|NCT02572427|Primary|Skill in Intubating Neonatal Manikin|Time in seconds needed to intubate neonatal manikin Skill test on neonatal resuscitation in simulation lab|Up to two minutes|||seconds||Standard Deviation|Mean
636086|NCT02571634|Secondary|Sedation Level Assessed by POSS Tool|At baseline, 15 minutes post medication receipt, 30 minutes , 45 minutes and at discharge a Pasero-Opioid Sedation Scale Score was obtained. This scale is to measure alertness and amount of sedation. POSS was the abbreviated term used for this scale. The guidelines for that scale include: S= sleeping easily aroused 1= alert and awake; 2= slightly drowsy easily aroused; 3= frequently drowsy, drifts off to sleep during conversation; 4= somnolent, minimal or no response|Baseline, 15 min, 30 min, 45 min, discharge|||POSS sedation scores||Standard Error|Mean
636087|NCT02571634|Secondary|Adverse Events|Volunteers are monitored closely with vs, and sedation levels and any adverse issues will be recorded.|24 hours|All 23 subjects were monitored with blood pressure, heart rate, oxygen saturation and sedation scores to determine any adverse events.||number of adverse events|||Number
636088|NCT02571634|Secondary|Patient Satisfaction Using a Likert Satisfaction Survey|At 24 hour after the procedure a call was made asking the volunteer to provide a number on a scale to describe their satisfaction with their pain control and their overall satisfaction. A 5 point likert scale was used 1 = very satisfied, 2 satisfied, 3 neither satisfied nor dis-satisfied, 4 not satisfied and 5 very unsatisfied.|24 hours|Subjects were asked about pain control satisfaction and overall satisfaction using a 5 point likert scale. 1 = very satisfied, 2= satisfied, 3= neither satisfied nor dis-satisfied, 4= not satisfied and 5 = very unsatisfied||Units on scale||Standard Deviation|Mean
636089|NCT02571634|Secondary|Pain Score Differences Using the DVPRS (Defense and Veterans Pain Rating Scale) Tool.|DVPRS pain scores will be recorded baseline and at 15 minutes post dosing, 30 minutes, 45 minutes and discharge. The DVPRS is a pain scale utilizing color coding descriptive terms and faces to describe pain levels from 0 meaning no pain and 10 the most excruciating pain ever.|Baseline, 15 min, 30 min, 45 min, and discharge|||pain score||Standard Error|Mean
636090|NCT02571634|Primary|Safety and Tolerability as Measured by the Number of Adverse Events|Adverse events will be recorded by a yes or no as to their occurence|24 hours|||adverse events|||Number
636091|NCT02571153|Secondary|Percentage of Participants With Tramadol Consumption|Percentage of Participants with Tramadol during the ward stay|24 hours|Patients aged 18 to 65 years old, with an ASA physical status I or II, who would be scheduled to undergo laparoscopic cholecystectomy.||percentage of participants|||Number
636092|NCT02571153|Secondary|The Severity of Postoperative Pain|"The severity of postoperative pain was rated the higher score of pain (NRS) during the hospital ward stay.
Pain was evaluated using a 0-10 numeric pain rating scale (NRS), where zero meant no pain and 10 the worst imaginable pain."|24 hours|Patients aged 18 to 65 years old, with an ASA physical status I or II, who would be scheduled to undergo laparoscopic cholecystectomy.||units on a scale||80% Confidence Interval|Mean
636093|NCT02571153|Secondary|Morphine Consumption (mg) at PACU|Morphine consumption (mg) at PACU (about 90 to 120 minutes)|During the stay at postanesthesia recovery room (about 90 to 120 minutes)|Patients aged 18 to 65 years old, with an ASA physical status I or II, who would be scheduled to undergo laparoscopic cholecystectomy.||mg||80% Confidence Interval|Mean
636094|NCT02571153|Secondary|Occurrence of Pain at PACU Using a 0-10 Numeric Pain Rating Scale|Occurrence of pain at the PACU. Average Pain will be calculated. The pain score will be evaluated using a 0-10 numeric pain rating scale, where zero mean no pain and 10 the worst imaginable pain.|90 minutes postanesthesia at recovery room|Patients aged 18 to 65 years old, with an ASA physical status I or II, who would be scheduled to undergo laparoscopic cholecystectomy.||units on a scale||80% Confidence Interval|Mean
636095|NCT02571153|Secondary|Occurrence of Postoperative, Nausea and Vomiting|Percentage of participants with postoperative nausea and vomiting at the PACU and during the hospital ward stay|24 hours|Patients aged 18 to 65 years old, with an ASA physical status I or II, who would be scheduled to undergo laparoscopic cholecystectomy.||percentage of participants|||Number
636096|NCT02571153|Secondary|Length of PACU Stay|Length of stay at postanesthesia recovery room|During the stay at postanesthesia recovery room (about 90 to 120 minutes)|Patients aged 18 to 65 years old, with an ASA physical status I or II, who would be scheduled to undergo laparoscopic cholecystectomy.||minutes||80% Confidence Interval|Mean
636097|NCT02571153|Primary|Quality of Postoperative Recovery Assessed by QoR-40 Questionnaire 24 Hours After Surgery|Quality of postoperative functional recovery assessed by the questionnaire QoR40 The quality of postoperative functional recovery was assessed by the QoR-40 questionnaire, which assesses five dimensions of recovery (physical comfort – 12 items; emotional state – 7 items; physical independence – 5 items; physiological support - 7 items; and pain – 7 items). Each item was rated on a five-point Likert scale: none of the time, some of the time, usually, most of the time, and all the time. The total score on the QoR-40 ranges from 40 (poorest quality of recovery) to 200 (best quality of recovery). The QoR-40 was administered by a blind investigator 24 hours after surgery.|24 hours|Total of 152 patients were first assessed for eligibility in this study; however, 17 were excluded because they refused participation, or met any of the exclusion criteria. Thus, 135 participants were randomly allocated to the study groups. Later, 6 participants in group S, 8 in group K2, and 2 in group K4 were excluded due to protocol deviations.||units on a scale||80% Confidence Interval|Mean
636098|NCT02570425|Secondary|Preference of Device Questionnaire 8 Weeks After Baseline Visit Assessed by PASAPQ Part II Q15 Score|Device preference for either Spiromax or Turbohaler device 8 weeks after baseline visit assessed by PASAPQ Part II Q15 score|8 weeks|||percent of participants|||Number
637245|NCT02499575|Primary|Opioid Use as Measured by Questionnaire|Compare time to first opioid use over 72 hours between groups|Daily through the third day (72 hours) post-surgery|||hours|||Number
636105|NCT02570425|Secondary|Number of Assessor-observed Errors Recalled at 4 Weeks After Baseline Visit by All Participants|Quantity of errors made at each level recalled by expert assessors at 4 weeks after baseline visit by all participants|4 weeks|||errors|||Number
636106|NCT02570425|Secondary|Number of Assessor-observed Errors Recalled During Baseline Visit by All Participants|Quantity of errors made at each level recalled during baseline visit by all participants using an expert assessor|0 weeks (Visit 1)|||errors|||Number
636107|NCT02570425|Secondary|The Number of Levels Out of a 6 Level Training Process Required by Each Patient on Achieving Device Mastery as Assessed by Expert Assessor|Number of levels required to achieve device mastery out of a 6 level training processrequired by each patient at each visit as assessed by expert assessor|4 weeks|||levels||Standard Deviation|Mean
636108|NCT02570425|Secondary|Number of Participants Achieving Device Mastery in Levels 1-6 After 8 Weeks From Baseline Visit as Assessed by Expert Assessor|Number of participants achieving mastery at each level in the 6 level training process after 8 weeks from baseline visit as assessed by expert assessor|8 weeks|||participants|||Number
636109|NCT02570425|Secondary|Number of Participants Achieving Device Masteryin Levels 1-6 After 4 Weeks From Baseline Visit as Assessed by Expert Assessor|Number of participants achieving mastery at each level in the 6 level training process after 4 weeks from baseline visit as assessed by expert assessor|0 weeks (Visit 1)|||participants|||Number
636110|NCT02570425|Secondary|Number of Participants Achieving Device Mastery at Levels 1-6 as Assessed by Expert Assessor|Number of participants achieving mastery at each level in the 6 level training process at baseline visit as assessed by expert assessor|0 weeks (Visit 1)|||participants|||Number
636111|NCT02570425|Secondary|Percentage of Participants Achieving Device Mastery at the End of Level 2 Out of a 6 Level Training Process at Week 8 as Assessed by Expert Assessor|Examined for both at the end of level 2 (out of 6 level training process). This will be compared using McNemar’s test of equality of paired proportions with a 0.050 two- sided significance level. A Conditional Logistic Regression Model was used to quantify the difference between the two inhalers by calculating the odds ratio for achieving mastery for Spiromax® (with Turbohaler® as the reference device) along with a 95% confidence interval for quantifying the precision of the odds ratio estimate.|8 weeks|||percent of participants|||Number
636112|NCT02570425|Secondary|Percentage of Participants Achieving Device Mastery at the End of Level 1 Out of a 6 Level Training Process at Week 8 as Assessed by Expert Assessor|Examined for both at the end of level 1 (out of 6 level training process). This will be compared using McNemar’s test of equality of paired proportions with a 0.050 two- sided significance level. A Conditional Logistic Regression Model was used to quantify the difference between the two inhalers by calculating the odds ratio for achieving mastery for Spiromax® (with Turbohaler® as the reference device) along with a 95% confidence interval for quantifying the precision of the odds ratio estimate.|8 weeks|||percent of participants|||Number
636113|NCT02570425|Secondary|Percentage of Participants Achieving Device Mastery at the End of Level 2 Out of a 6 Level Training Process at Week 4 as Assessed by Expert Assessor|Examined at the end of level 2 (out of 6 level training process). This will be compared using McNemar’s test of equality of paired proportions with a 0.050 two- sided significance level. A Conditional Logistic Regression Model was used to quantify the difference between the two inhalers by calculating the odds ratio for achieving mastery for Spiromax® (with Turbohaler® as the reference device) along with a 95% confidence interval for quantifying the precision of the odds ratio estimate.|4 weeks|||percent of participants|||Number
636114|NCT02570425|Secondary|Percentage of Participants Achieving Device Mastery at the End of Level 1 Out of a 6 Level Training Process at Week 4 as Assessed by Expert Assessor|Examined at the end of level 1 (out of 6 level training process). This will be compared using McNemar’s test of equality of paired proportions with a 0.050 two- sided significance level. A Conditional Logistic Regression Model was used to quantify the difference between the two inhalers by calculating the odds ratio for achieving mastery for Spiromax® (with Turbohaler® as the reference device) along with a 95% confidence interval for quantifying the precision of the odds ratio estimate.|4 weeks|||percent of participants|||Number
636115|NCT02570425|Secondary|Percentage of Participants Achieving Device Mastery at the End of Level 2 Out of a 6 Level Training Process as Assessed by Expert Assessor|Examined for both at the end of level 2 (out of 6 level training process). This will be compared using McNemar’s test of equality of paired proportions with a 0.050 two- sided significance level. A Conditional Logistic Regression Model was used to quantify the difference between the two inhalers by calculating the odds ratio for achieving mastery for Spiromax® (with Turbohaler® as the reference device) along with a 95% confidence interval for quantifying the precision of the odds ratio estimate.|0 weeks (Visit 1)|||percent of participants|||Number
636116|NCT02570425|Secondary|Percentage of Participants Achieving Device Mastery at the End of Level 1 Out of a 6 Level Training Process as Assessed by Expert Assessor|Examined for both at the end of level 1 (out of 6 level training process). This will be compared using McNemar’s test of equality of paired proportions with a 0.050 two- sided significance level. A Conditional Logistic Regression Model was used to quantify the difference between the two inhalers by calculating the odds ratio for achieving mastery for Spiromax® (with Turbohaler® as the reference device) along with a 95% confidence interval for quantifying the precision of the odds ratio estimate.|0 weeks (Visit 1)|||percent of participants|||Number
636117|NCT02570425|Primary|Percentage of Participants Maintaining Correct Inhaler Technique for Spiromax Compared With Turbohaler 4 Weeks After Training as Assessed by Expert Assessor|"Examine if recall of device mastery is superior for the SPIROMAX inhaler as compared to the TURBOHALER after training to device mastery on both devices.
The proportion of subjects achieving mastery of inhaler technique between the two inhaler devices was compared using McNemar’s test of equality of paired proportions with a 0.050 two- sided significance level. A Conditional Logistic Regression Model was used to quantify the difference between the two inhalers by calculating the odds ratio for achieving mastery for Spiromax® (with Turbohaler® as the reference device) along with a 95% confidence interval for quantifying the precision of the odds ratio estimate."|4 weeks|||percent of participants|||Number
636130|NCT02570022|Primary|Pain Levels|Patients recorded pain levels every four hours using Visual analog scales for four days post operatively. Average daily pain was calculated for each patient. Range of the visual analog scale was 0-10, where 0 indicated a lower amount of pain and 10 indicated higher amount of pain.|four days postoperatively|||units on a scale||Standard Deviation|Mean
652299|NCT02010684|Secondary|Change From Baseline in Blood Pressure at 6 Months||Baseline and 6 months|||mm Hg||Standard Deviation|Mean
636118|NCT02570295|Other Pre-specified|Daily Distance Covered on Foot|Daily distance covered on foot was measured using two accelerometers and one heart rate sensor. Data from weeks 2-9 of the basic military were combined and a single value (mean) was calculated for each group.|Weeks 2 - 9 of the basic military training|The overall number of participants analyzed is smaller than the corresponding number in the participant flow module, because only an exemplary sample of 40 participants per group were chosen to wear the sensors due to financial reasons.||km per day||Standard Deviation|Mean
636119|NCT02570295|Other Pre-specified|Daily Energy Expenditure|Daily energy expenditure was measured using two accelerometers and one heart rate sensor. Data from weeks 2-9 of the basic military were combined and a single value (mean) was calculated for each group.|Weeks 2 - 9 of the basic military training|The overall number of participants analyzed is smaller than the corresponding number in the participant flow module, because only an exemplary sample of 40 participants per group were chosen to wear the sensors due to financial reasons.||Megajoule per day||Standard Deviation|Mean
636120|NCT02570295|Other Pre-specified|Questionnaire About Sport Lessons|Duration of each sport session was registered in a questionnaire by the military personnel. The minimum would be 0 minutes of sport per week, for the maximum the scale is open-ended. Data of sport lessons during the whole basic military are combined and presented as a mean value for each group.|During the whole basic military training (18 weeks)|||minutes of sport per week||Standard Deviation|Mean
636121|NCT02570295|Secondary|Attrition Rate|Withdrawals from the military service are reported by the training school's secretariat|During the whole basic military training (18 weeks)|||participants|||Number
636122|NCT02570295|Secondary|Questionnaire About Health and Physical Activities||Week 1 of the basic military training and 3 months after finishing the basic military training|The overall number of participants analyzed is smaller than the corresponding number in the participant flow module, because only participants who completed the questionnaire at both time points were included in the analysis.||Minutes of physical activity per week||Standard Deviation|Mean
636123|NCT02570295|Secondary|Military Performance According to Military Marks|Military marks are given by superior Army personnel. The total score ranges from 1 (insufficient) to 5 (excellent). In total, three marks are given during the whole basic military training (after 7, 11 and 16 weeks). Data from those three time points are combined in a single value (mean).|During the basic military training (18 weeks)|The overall number of participants analyzed is smaller than the corresponding number in the participant flow module, because only participants from whom military marks were available for the whole basic military training were included in the analysis.||units on a scale 1-5||Standard Deviation|Mean
636124|NCT02570295|Secondary|Psychological Questionnaires|2 questionaires concerning resilience were used: The Resilience Scale 11 (Schumacher, Leppert, Gunzelmann, Strauss & Brähler, 2005) and the Brief Resilience Scale (Smith, Dalen, Wiggings, Tooley, Christopher & Bernard, 2008). A mean was calculated for each time point. The total score ranges from 1 (worst result) to 7 (best result).|Weeks 2, 10 and 16 of the basic military training|The overall number of participants analyzed is smaller than the corresponding number in the participant flow module, because only participants who the psychological questionnaires at all three time points were included in the analysis.||units on a scale 1-7||Standard Deviation|Mean
636125|NCT02570295|Secondary|Physical Fitness Measured With the Swiss Physical Fitness Test Battery (SPFTB)|"Physical Fitness is measured with the Swiss physical fitness test battery (SPFTB).
The SPFTB contains a progressive endurance run, a trunk muscle strength test, a standing long jump, a seated shot put, and a one-leg standing test. From the results of those performance tests (0 to 25 points each), a total fitness score is calculated (sum of all points). The minimum total score (worst result) is 0 points, the maximum total score (best result) is 125 points. A detailed description of the SPFTB can be found in the publication of Wyss, Marti, Rossi, Kohler and Mäder (2007)."|Weeks 2, 10 and 16 of the basic military training|The overall number of participants analyzed is smaller than the corresponding number in the participant flow module, because only participants who completed all three fitness tests were included in the analysis.||units on a scale from 0 to 125||Standard Deviation|Mean
636126|NCT02570295|Primary|Number of Participants With Injuries|All injuries which are registered in the patient's medical record are collected and classified. A classification system which takes into account anatomical site, circumstances of the accident, and severity of the injury is used.|During the basic military training (18 weeks)|The overall number of participants analyzed is smaller than the corresponding numbers in the participant flow module, because only participants who finished the whole 18-weeks basic military training were included in the analysis.||participants with injuries|||Number
636127|NCT02570165|Secondary|Change From Baseline in Trough FEV1 at Day 42|Trough FEV1 at Day 42 is the mean volume of air that can be forced out in one second after taking a deep breath at the approximately 23 Hrs and 24 Hrs assessments after the last administration of study drug. Batefenterol dose for each individual was compared with placebo or UMEC/VI. Change from Baseline was calculated as trough FEV1 on Day 42 minus baseline, where Baseline is defined as the average of Day1 pre-dose FEV1 measured at -30 minutes and 0 minutes. The Maximum Likelihood Estimation (MLE) method of dose response modeling with Emax modeling without Bayesian priors was used. Participants with FEV1 values available at Baseline and Day 42 after 24 hrs after the last administration of study drug were analyzed.|Baseline and Day 42|ITT Population||mL||Standard Error|Mean
636128|NCT02570165|Primary|Change From Baseline in Weighted Mean FEV1 Over 0 to 6 Hours Post-dose at Day 42|FEV1 is defined as the volume of air that can be forced out in one second after taking a deep breath. Weighted-mean change from Baseline was the weighted-mean FEV1 on Day 42 minus Baseline where Baseline is defined as the average of Day1 pre-dose FEV1 measured at -30 minutes and 0 minutes. The 0-6 hour (Hr.) serial FEV1 was collected at Day 1 (Visit 2) and Day 42 (Visit 6). The weighted-mean was derived by calculating the area under the curve (AUC) of FEV1 over the 6 hour period, and then dividing it by the 6-hour time interval. Batefenterol dose for each individual was compared with placebo or UMEC/VI. The change from Baseline in FEV1 was statistically analyzed using Bayesian Emax modeling of the dose response curve. Intent-to-Treat (ITT) Population comprised of all participants randomized to treatment and who received at least one dose of study medication. Participants with FEV1 values available at Baseline and Day 42 were analyzed.|Baseline and Day 42|ITT Population.||Milliliters (mL)||Standard Error|Mean
636129|NCT02570022|Secondary|Morphine Equivalents|Patients recorded opioid intake for four days postoperatively. Patients average daily morphine consumption was determined by averaging total patients daily morphine consumption by the number of patients.|four days postoperatively|||mg of morphine equivalent||Standard Deviation|Mean
636131|NCT02569996|Secondary|Disease-free Survival (DFS)|Disease free survival (DFS) being defined as time from first documented complete response to induction treatment to relapse or progression or death from the follicular lymphoma. Mean DFS was estimated by the Kaplan-Meier estimation and provided with their 95% confidence interval.|From first documented complete response to induction treatment to relapse or progression or death, whichever occurs first, assessed up to 5 years|ITT population: All participants who received at least one maintenance rituximab infusion were included in the analysis. Subset of the ITT population was used since not the entire ITT population provided appropriate data for analysis.||months||95% Confidence Interval|Mean
636132|NCT02569996|Secondary|Duration of Response (DR)|Duration of Response (DR) defined as time from first documented response to induction treatment to relapse or progression or death from the follicular lymphoma. Mean DR was estimated by the Kaplan-Meier estimation and provided with their 95% confidence interval.|From first documented response to induction treatment to relapse or progression or death, assessed up to 5 years|ITT population: All participants who received at least one maintenance rituximab infusion were included in the analysis. Subset of the ITT population was used since not the entire ITT population provided appropriate data for analysis||months||95% Confidence Interval|Mean
636133|NCT02569996|Secondary|Time to Next Anti-lymphoma Treatment (TTNLT)|Time to next anti-lymphoma treatment (TTNLT) defined as time from baseline to institution of a new antilymphoma regimen (including chemo-, radio- or immunotherapies). Mean TTNLT was estimated by the Kaplan-Meier estimation and provided with their 95% confidence interval.|From baseline (Week 0) to institution of a new antilymphoma regimen, assessed up to 5 years|ITT population: All participants who received at least one maintenance rituximab infusion were included in the analysis.||months||95% Confidence Interval|Mean
636134|NCT02569996|Secondary|Time to Progression (TTP)|Time to progression (TTP) defined as time from baseline to disease progression or relapse, death from the follicular lymphoma or institution of a new regimen because of the follicular lymphoma. Mean TTP was estimated by the Kaplan-Meier estimation and provided with their 95% confidence interval. ITT population was used for this analysis.|From baseline (Week 0) to disease progression, relapse, death from the follicular lymphoma or institution of a new regimen, whichever occurs first, assessed up to 5 years|ITT population: All participants who received at least one maintenance rituximab infusion were included in the analysis.||months||95% Confidence Interval|Mean
636135|NCT02569996|Secondary|Overall Survival (OS)|Overall survival, defined as the time between baseline (Week 0) and the date of death irrespective of the cause of death. Mean OS was estimated by the Kaplan-Meier estimation and provided with their 95% confidence interval. ITT population was used for this analysis.|From randomization until death, assessed up to 5 years|ITT population: All participants who received at least one maintenance rituximab infusion were included in the analysis.||months||95% Confidence Interval|Mean
636136|NCT02569996|Secondary|Number of Participants With Adverse Events (AEs)|An adverse event (AE) was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. A serious adverse event (SAE) was defined as any untoward medical occurrence that is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect, requires intervention to prevent permanent impairment or damage, or results in death|Up to 27 months|Safety population: All participants who received at least one dose of study medication and had safety data after the first dose of study drug.||participants|||Number
636137|NCT02569996|Primary|Event-free Survival|Event-free survival (EFS) was defined as the time from baseline (Week 0) to the time to progression, relapse, death from any cause, or institution of a new treatment, whichever occurs first. Mean EFS was estimated by the Kaplan-Meier estimation and provided with their 95% confidence interval. ITT population (patients who received at least one maintenance MabThera infusion) was used for this analysis.|From randomization to the time to progression, relapse, death from any cause, or institution of a new treatment, whichever occurs first, assessed up to 5 years|ITT population: All participants who received at least one maintenance rituximab infusion were included in the analysis.||months||95% Confidence Interval|Mean
636138|NCT02569658|Secondary|Number of Participants With Stroke|Must be diagnosed via CT scan or MRI|30 days post-operative|||Participants|||Count of Participants
636139|NCT02569658|Secondary|Number of Participants With Pulmonary Embolism|Must be diagnosed via CT chest or V/Q lung scan|30 days post-operative|||Participants|||Count of Participants
636140|NCT02569658|Secondary|Number of Participants With Deep Vein Thrombosis|Must be diagnosed via ultrasound duplex|30 days post-operative|||Participants|||Count of Participants
636141|NCT02569658|Secondary|Number of Patients Transfused|Patients who received a post-op transfusion of pack red blood cells|Average of 3 days post-operatively|||Participants|||Count of Participants
636142|NCT02569658|Secondary|Number of Units Transfused|Units of pack red blood cells that the patients recieved|Average of 3 days post-operatively|||Units of PRBCs|||Number
636143|NCT02569658|Primary|Post-operative Blood Loss|Equated based on the patient's predicted blood volume and change in hemoglobin from the pre-operative level to the lowest post-operative level.|Average of 3 days post-operatively|||mL||Standard Deviation|Mean
636144|NCT02568852|Secondary|Thrombin Time(TT)|measures of the extrinsic and intrinsic pathway of coagulation|Post-operative 24th hours|All patients have gall bladder disease who are between 18-80 years old.||seconds||Standard Deviation|Mean
636145|NCT02568852|Secondary|Thrombin Time(TT)|measures of the extrinsic and intrinsic pathway of coagulation|Post-operative 1st hour|All patients have gall bladder disease who are between 18-80 years old.||seconds||Standard Deviation|Mean
636146|NCT02568852|Secondary|Thrombin Time(TT)|measures of the extrinsic and intrinsic pathway of coagulation|pre-operative|All patients have gall bladder disease who are between 18-80 years old.||seconds||Standard Deviation|Mean
636147|NCT02568852|Secondary|aPTT(Activated Partial Thromboplastin Time)|measures of the intrinsic pathway of coagulation|Post-operative 24th hours|All patients have gall bladder disease who are between 18-80 years old.||seconds||Standard Deviation|Mean
636148|NCT02568852|Secondary|aPTT(Activated Partial Thromboplastin Time)|measures of the intrinsic pathway of coagulation|Post-operative 1st hour|All patients have gall bladder disease who are between 18-80 years old.||seconds||Standard Deviation|Mean
636149|NCT02568852|Secondary|aPTT(Activated Partial Thromboplastin Time)|measures of the intrinsic pathway of coagulation|pre-operative|All patients have gall bladder disease who are between 18-80 years old.||seconds||Standard Deviation|Mean
636150|NCT02568852|Secondary|D-Dimer|A fibrin degradation product (or FDP) present in the blood after a blood clot is degraded by fibrinolysis|Post-operative 24th hours|All patients have gall bladder disease who are between 18-80 years old.||mg/L||Standard Deviation|Mean
636151|NCT02568852|Secondary|D-Dimer|A fibrin degradation product (or FDP) present in the blood after a blood clot is degraded by fibrinolysis|Post-operative 1st hour|All patients have gall bladder disease who are between 18-80 years old.||mg/L||Standard Deviation|Mean
636152|NCT02568852|Secondary|D-Dimer|A fibrin degradation product (or FDP) present in the blood after a blood clot is degraded by fibrinolysis|pre-operative|All patients have gall bladder disease who are between 18-80 years old.||mg/L||Standard Deviation|Mean
636153|NCT02568852|Secondary|PT(Prothrombin Time)|measures of the extrinsic pathway of coagulation|Post-operative 24th hours|All patients have gall bladder disease who are between 18-80 years old.||seconds||Standard Deviation|Mean
636154|NCT02568852|Secondary|PT(Prothrombin Time)|measures of the extrinsic pathway of coagulation|Post-operative 1st hour|||seconds||Standard Deviation|Mean
636155|NCT02568852|Secondary|PT(Prothrombin Time)|measures of the extrinsic pathway of coagulation|pre-operative|All patients have gall bladder disease who are between 18-80 years old.||seconds||Standard Deviation|Mean
636156|NCT02568852|Secondary|Fibrinogen Level|A soluble plasma glycoprotein, that is converted by thrombin into fibrin during blood clot formation|Post-operative 24th hour|All patients have gall bladder disease who are between 18-80 years old.||mg/dL||Full Range|Median
636157|NCT02568852|Secondary|Fibrinogen Level|A soluble plasma glycoprotein, that is converted by thrombin into fibrin during blood clot formation|Post-operative 1 st hour|All patients have gall bladder disease who are between 18-80 years old.||mg/dL||Full Range|Mean
636158|NCT02568852|Secondary|Fibrinogen Level|A soluble plasma glycoprotein, that is converted by thrombin into fibrin during blood clot formation|pre-operative|All patients have gall bladder disease who are between 18-80 years old.||mg/dL||Full Range|Mean
636159|NCT02568852|Primary|Duration of Operation|group1 and group 2(Duration of Operation)|up to 2 hours|All patients have gall bladder disease who are between 18-80 years old.||minutes||Full Range|Mean
636160|NCT02568384|Other Pre-specified|Average Change in Total Daily Insulin Dose From Study Start to End of Study|Subjects' self-reported Total Daily Insulin Doses at visit 1 were compared with their self-reported Total Daily Insulin Doses at Visit 2 (end of study).|3 weeks|||insulin units||Full Range|Mean
636161|NCT02568384|Other Pre-specified|Average Change in Subject Body Weight From Study Start to End of Study|Subject Body Weight results at visit 1 were compared with Body Weight results at Visit 2 (end of study).|3 weeks|||pounds||Full Range|Mean
636162|NCT02568384|Other Pre-specified|Average Change in Subject Fructosamine From Study Start to End of Study|Laboratory reports were used to compare Fructosamine results from subjects at visit 1 with Fructosamine results at Visit 2 (end of study).|3 weeks|Change in umol/L||umol/L||Full Range|Mean
636163|NCT02568384|Other Pre-specified|HbA1c% From Study Start to End of Study|Laboratory reports were used to compare HbA1c results from subjects at visit 1 with HbA1c results at Visit 2 (end of study).|3 weeks|Change in %HbA1c.||%HbA1c||Full Range|Mean
636164|NCT02568384|Secondary|Percent of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neither Agree Nor Disagree' With Questionnaire Statements Regarding Clarity and Utility of User Instructions For Onyx Glucose Meter and App System|Staff obtained responses from persons with diabetes using short questionnaires to provide feedback on the clarity and utility of user instructions for the Onyx Glucose Meter and App System. Subjects could respond '1Strongly Agree' or '2Agree' or '3Neither Agree nor Disagree' or '4Disagree' or '5Strongly Disagree' or ‘6No Opinion’.|3 weeks|While 43 subjects completed the questionnaire, responses with 'No opinion' were not counted in the total used to calculate percent of responses for each statement.||percentage of responses <or = 3|||Number
636165|NCT02568384|Secondary|Percent of Responses From Persons With Diabetes That Rated Ease of Use For Onyx Glucose Meter and App System as Either Very Simple or Simple or Neither Simple Nor Difficult|Staff obtained responses from persons with diabetes using short questionnaires to provide feedback on the basic operation of the Onyx Glucose Meter and App System. Subjects could respond '1Very Simple' or '2Simple' or '3Neither Simple nor Difficult' or '4Difficult' or '5Very Difficult' or ‘6No Opinion’.|3 weeks|While 43 subjects completed the questionnaire, responses with 'No opinion' were not counted in the total used to calculate percent of responses for each statement.||Percentage of Responses|||Number
636166|NCT02568384|Primary|Percent of Responses From Persons Who Performed Each “Software Operations” Task and Rated Each Statement as Strongly Agree, Agree, or Neither Agree Nor Disagree.|"For “software operations” tasks, subjects rated statements about software operations tasks as 1Strongly Agree, 2Agree, 3Neither Agree nor Disagree, 4Disagree, 5Strongly Disagree, or 6No opinion. Software operations tasks included:
Obtain a synced blood glucose reading
Initiation and use of insulin bolus calculator
Access and interpret glucose displays such as expanded graph (modal day) and sequential views."|3 weeks|While 43 subjects completed the questionnaire, responses with 'No opinion' were not counted in the total used to calculate percent of responses for each statement.||Percent of Responses|||Number
636167|NCT02568345|Primary|Sugammadex ED90|"Complete reversal of neuromuscular blockade occured when the patient had a TOF T4/T1 ≥ 0.9 within eight minutes of sugammadex infusion.
The sequencial design method of up-and-down was applied to determine the minimum effective dose in 90% of patients (ED90). An effective dose is one that achieves complete reversal of neuromuscular blockade that is defined as a measure of TOF equal or higher than 0.9, or a relationship between T4 an T1 measure ≥ 0.9, within eight minutes of sugammadex infusion."|8 minutes|||mg/kg||99% Confidence Interval|Number
636168|NCT02568254|Primary|Overall Comfort|Clue comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.|2- Week Follow-up|Subjects that completed all study visits without a major protocol deviation.||Units on a scale||Standard Deviation|Mean
636190|NCT02567188|Primary|Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 6 After Inclusion||Month 6|All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.||percentage of participants|||Number
636169|NCT02567188|Secondary|Percentage of Participants Who Required Renal Replacement Therapy|Renal replacement therapy was defined as hemodialysis and peritoneal dialysis.|Months 3, 6, 9, and 12|All enrolled participants. Here, number of participants analyzed= participants evaluable for this outcome measure and n= participants evaluable for specified time points.||percentage of participants|||Number
636170|NCT02567188|Secondary|Percentage of Participants Who Required Blood Transfusion||Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12|All enrolled participants. Here, number of participants analyzed= participants evaluable for this outcome measure and n= participants evaluable for specified time points.||percentage of participants|||Number
636171|NCT02567188|Secondary|Number of Participants With Different Medication Treatment|Number of participants who were receiving different treatments (antihypertensive, immunosuppressive, iron supplements, and others) before and/or after baseline were reported. Same participant could be reported in more than one category.|Pre-baseline (Month -6) to Month 12|All enrolled participants. Here, number of participants analyzed= participants evaluable for this outcome measure.||participants|||Number
636172|NCT02567188|Secondary|Percentage of Participants With Changes in AntihypertensiveTreatment|Percentage of participants who had any change in their antihypertensive medication at a specified visit were reported.|Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12|All enrolled participants. Here, number of participants analyzed = participants evaluable for this outcome measure and n= participants evaluable for specified time points.||percentage of participants|||Number
636173|NCT02567188|Secondary|Percentage of Participants With Changes in Immunosuppressive Treatment|Percentage of participants who had any change in their immunosuppressive medication at a specified visit were reported.|Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12|All enrolled participants. Here, number of participants analyzed = participants evaluable for this outcome measure and n= participants evaluable for specified time points.||percentage of participants|||Number
636174|NCT02567188|Primary|Percentage of Participants With Hb Fluctuation From Baseline to Month 12|Hb fluctuation was defined as change in Hb value >15 gm/L between 2 visits.|Baseline to Month 12|All enrolled participants. Here, number of participants analyzed= participants with at least 2 non-missing Hb assessments between baseline and Month 12.||percentage of participants|||Number
636175|NCT02567188|Primary|Percentage of Participants With Hb Fluctuation From Pre-Baseline (Month -6) to Baseline|Hb fluctuation was defined as change in Hb value >15 gm/L between 2 visits.|Pre-baseline (Month -6) to Baseline|All enrolled participants. Here, number of participants analyzed= participants with at least 2 non-missing Hb assessments between pre-baseline (Month -6) and baseline.||percentage of participants|||Number
636176|NCT02567188|Primary|Mean Hb Value at Month 12 After Inclusion||Month 12|All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.||gm/L||Standard Deviation|Mean
636177|NCT02567188|Primary|Mean Hb Value at Month 9 After Inclusion||Month 9|All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.||gm/L||Standard Deviation|Mean
636178|NCT02567188|Primary|Mean Hb Value at Month 6 After Inclusion||Month 6|All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.||gm/L||Standard Deviation|Mean
636179|NCT02567188|Primary|Mean Hb Value at Month 3 After Inclusion||Month 3|All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.||gm/L||Standard Deviation|Mean
636180|NCT02567188|Primary|Mean Hb Value at Baseline||Baseline|All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.||gm/L||Standard Deviation|Mean
636181|NCT02567188|Primary|Mean Hb Value at Month 3 Before Inclusion||Pre-baseline (Month -3)|All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.||gm/L||Standard Deviation|Mean
636182|NCT02567188|Secondary|Percentage of Participants With Changes in Iron Supplement|Percentage of participants who had any change in their iron supplement medication at a specified visit were reported.|Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12|All enrolled participants. Here, number of participants analyzed= participants evaluable for this outcome measure and n= participants evaluable for specified time points.||percentage of participants|||Number
636183|NCT02567188|Secondary|Correlation of Hb Levels With Levels of Inflammation||Baseline to 12 months|The units usage at and between study centres did change during the study and therefore no descriptive statistics could be performed on the laboratory variables.|||||
636184|NCT02567188|Secondary|Correlation of Hb Levels With Underlying Disease||Baseline to 12 months|The units usage at and between study centres did change during the study and therefore no descriptive statistics could be performed on the laboratory variables.|||||
636185|NCT02567188|Secondary|Percentage of Participants With Number of MIRCERA Dose Changes||Baseline to Month 12|All enrolled participants. Here, number of participants analyzed= participants with available data for this outcome measure.||percentage of participants|||Number
636186|NCT02567188|Secondary|Percentage of Participants With Change in MIRCERA Treatment|Change in MIRCERA treatment included changes in dose, frequency, and route of administration.|Months 3, 6, 9, and 12|All enrolled participants. Here, number of participants analyzed= participants evaluable for this outcome measure. n = number of participants evaluable at the specified time frame.||percentage of participants|||Number
636187|NCT02567188|Primary|Mean Hb Value at Month 6 Before Inclusion||Pre-baseline (Month -6)|All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.||gm/L||Standard Deviation|Mean
636188|NCT02567188|Primary|Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 12 After Inclusion||Month 12|All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.||percentage of participants|||Number
636189|NCT02567188|Primary|Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 9 After Inclusion||Month 9|All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.||percentage of participants|||Number
636191|NCT02567188|Primary|Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 3 After Inclusion||Month 3|All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.||percentage of participants|||Number
636192|NCT02567188|Primary|Percentage of Participants Reaching a Hb Value of >100 and < 120 gm/L at Baseline||Baseline|All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.||percentage of participants|||Number
636193|NCT02567188|Primary|Percentage of Participants Reaching a Hb Value of >100 and < 120 gm/L at Month 3 Before Inclusion||Pre-baseline (Month -3)|All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.||percentage of participants|||Number
636194|NCT02567188|Primary|Percentage of Participants Reaching a Hemoglobin (Hb) Value of Greater Than (>) 100 and Less Than (<) 120 Grams Per Liter (gm/L) at Month 6 Before Inclusion||Pre-baseline (Month -6)|All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.||percentage of participants|||Number
636195|NCT02565628|Secondary|Area Under Curve From Time Zero to 24 Hours (AUC24) of PF-06669571 on Day 7|AUC24 of PF-06669571 refers to the area under the curve from time zero to 24 hours post dose on Day 7. AUC24 was determined by using linear/log trapezoidal method|0, 1, 3, 5, 8, 12 and 24 hours post-dose on Day 7|The PF-06669571 PK parameter analysis set was used for this analysis, and it was defined as all subjects randomized and treated who have at least 1 of the PK parameters of interest measured.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
636196|NCT02565628|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06669571 on Day 1 and Day 7|Tmax of PF-06669571 was observed directly from data on Day 1 and Day 7, as time of first occurrence.|0, 1, 3, 5, 8 and 12 hours post-dose on both Day 1 and Day 7|The PF-06669571 PK concentration analysis set was used for this analysis, and it was defined as all subjects randomized and treated who have at least 1 measureable concentration of interest.||hr||Full Range|Mean
636197|NCT02565628|Secondary|Area Under Curve From Time Zero to 12 Hours (AUC12) of PF-06669571 on Day 1 and Day 7|AUC12 of PF-06669571 refers to the area under the curve from time zero to 12 hours post dose on Day 1 and Day 7. AUC12 was determined by using linear/log trapezoidal method.|0, 1, 3, 5, 8 and 12 hours post-dose on both Day 1 and Day 7|The PF-06669571 PK parameter analysis set was used for this analysis, and it was defined as all subjects randomized and treated who have at least 1 of the PK parameters of interest measured.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
636198|NCT02565628|Secondary|Maximum Observed Plasma Concentration (Cmax) of PF-06669571 on Day 1 and Day 7|Cmax of PF-06669671 was observed directly from data on Day 1 and Day 7|0, 1, 3, 5, 8 and 12 hours post-dose on both Day 1 and Day 7|The PF-06669571 pharmacokinetics(PK) concentration analysis set was used for this analysis, and it was defined as all subjects randomized and treated who have at least 1 measureable concentration of interest.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
636199|NCT02565628|Primary|Number of Participants With Laboratory Abnormalities That Met Categorical Criteria for Concern (Without Regard to Baseline Abnormality)|Number of participants with a laboratory abnormality meeting specified criteria. The laboratory test included: hematology (hemoglobin, hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet count, white blood cell count, absolute total neutrophils, absolute eosinophils, absolute basophils, absolute monocytes, and absolute lymphocytes),liver function(total bilirubin, direct bilirubin, aspartate, aspartate aminotransferase, alanine, alanine aminotransferase, alkaline phosphatase, total protein, and albumin), renal function (blood urea nitrogen, creatinine, and uric acid), electrolytes (sodium, potassium, chloride, calcium, and venous bicarbonate), clinical chemistry(glucose) ,and urinalysis (pH, qualitative glucose, qualitative protein, qualitative blood, qualitative ketones, qualitative bilirubin, nitrites, leukocyte esterase, urine urobilinogen, urine leukocyte, esterase and microscopy).|Screening, Days 1, 4, and 7, and follow-up visit|All enrolled participants who started treatment.||participants|||Number
636200|NCT02565628|Primary|Primary: Number of Participants With Electrocardiogram (ECG) That Met Categorical Criteria for Concern(Increase From Baseline)|Number of participants with ECG(standard 12-lead) meeting the following criteria was reported: Criterion A: maximum PR interval increase from baseline percentage change (PctChg)>=25/50%; Criterion B: maximum QRs complex increase from baseline PctChg >=50%; Criterion C: maximum QTcF interval increase from baseline 30<=change<60 msec; Criterion D: maximum QTcF interval increase from baseline change >=60 msec.|Screening, Days 1, 7, and 8, and follow-up visit|All enrolled participants who started treatment||participants|||Number
636201|NCT02565628|Primary|Number of Participants With Electrocardiogram (ECG) That Met Categorical Criteria for Concern (Absolute Value)|The number of participants with ECG absolute values meeting the following criteria was reported: Criterion A: maximum PR interval (time from the beginning of P wave to the start of QRS complex, corresponding to the end of atrial depolarization and onset of ventricular depolarization) >=300 msec; Criterion B: maximum QRs complex(time from Q wave to the end of S wave, corresponding to ventricle depolarization) >=140 msec; Criterion C: maximum QTcF interval (time from the beginning of Q wave to the end of T wave corresponding to electrical systole, corrected for heart rate using Fridericia’s formula) 450-<480 msec; Criterion D: maximum QTcF interval 480-<500 msec; Criterion E: maximum QTcF interval (Fridericia’s correction) >=500 msec|Screening, Days 1, 7, and 8, and follow-up visit|All enrolled participants who started treatment||participants|||Number
636202|NCT02565628|Primary|Number of Participants With Supine and Standing Vital Sign Abnormalities (Decrease From Baseline)|The number of participants with vital signs data of maximum decrease from baseline meeting the following criteria was reported: Criterion A: maximum decrease from baseline in supine systolic BP (SBP) >=30 mmHg; Criterion B: maximum decrease from baseline in standing SBP >=30 mmHg; Criterion C: maximum decrease from baseline in supine diastolic BP(DBP) >=20 mmHg; Criterion D: maximum decrease from baseline in standing diastolic BP(DBP) >=20 mmHg|Screening, Days -1, 1, 7 and 8, and follow-up visit|All enrolled participants who started treatment||participants|||Number
636217|NCT02565381|Secondary|Smoking Abstinence at End of Study|Point-prevalence smoking abstinence, defined as an exhaled carbon monoxide level <8ppm, at the 14th (final) study visit.|8 weeks|||Participants|||Count of Participants
639968|NCT02368314|Secondary|Frequency of DTV|Frequency of DTV (proximal and/or distal; symptomatic or asymptomatic)|During the treatment period (14 days) and follow-up period (till 60-th day)||||||
636203|NCT02565628|Primary|Number of Participants With Supine and Standing Vital Sign Abnormalities of Potential Clinical Concern (Increase From Baseline)|The number of participants with vital signs data of maximum increase from baseline meeting the following criteria was reported: Criterion A: maximum increase from baseline in supine systolic BP (SBP) >=30 millimeters of mercury (mmHg); Criterion B maximum increase from baseline in standing SBP >=30 mmHg; Criterion C: maximum increase from baseline in supine diastolic BP(DBP) >=20 mmHg; Criterion D: maximum increase from baseline in standing diastolic BP(DBP) >=20 mmHg|Screening, Days -1, 1, 7 and 8, and follow-up visit|All enrolled participants who started treatment||participants|||Number
636204|NCT02565628|Primary|Number of Participants With Supine and Standing Vital Sign Abnormalities of Potential Clinical Concern (Absolute Values)|Number of participants with supine and standing vital signs data of absolute values meeting criteria of potential clinical concern. Absolute values were analyzed for supine/standing systolic blood pressure (SBP), supine/standing diastolic blood pressure (DBP), and supine/standing pulse rate. Number of participants with vital signs data meeting the following criteria was reported: (1) absolute supine SBP <90 millimeters of mercury (mmHg); (2) absolute standing SBP <90 mmHg; (3)absolute supine DBP<50mmHg; (4)absolute standing DBP<50mmHg (5) absolute supine pulse rate <40 beats per minute (bpm); (6) absolute supine pulse rate >120 bpm;(7) absolute standing pulse rate <40 bpm; (8) absolute standing pulse rate >140 bpm.|Screening, Days -1, 1, 7 and 8, and follow-up visit|All enrolled participants who started treatment||participants|||Number
636205|NCT02565628|Primary|Number of Participants With Treatment Emergent Adverse Events (All Causalities)|An adverse event (AE) was any untoward medical occurrence in a clinical investigation subject administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage.|Day 1 to 28 calendar days after the last dose of investigational product|All enrolled participants who started treatment||participants|||Number
636206|NCT02565628|Primary|Number of Participants With New Onset and Worsening of Post-Baseline Suicidality.|Number of participants with new onset and worsening of post-baseline suicidality was reported|Day 8 or follow-up visit (Day 7 - 14 after last dose of PF-06669571)|All enrolled participants who started treatment||participants|||Number
636207|NCT02565628|Primary|Number of Participants in Each Columbia Classification Algorithm of Suicide Assessment (C-CASA) Category by Study Visit on Day -2, Day 8 or Early Withdrawal, and Early Withdrawal/Follow-Up Visit|"The number of participants in each C-CASA category was mapped from Columbia-Suicide Severity Rating Scale (C-SSRS) data. C-SSRS assessed whether participant experienced following: completed suicide (1), suicide attempt (2) (response of Yes on actual attempt), preparatory acts toward imminent suicidal behavior (3) (Yes on preparatory acts or behavior), suicidal ideation (4) (Yes on wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act or some intent to act, with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7) (Yes on Has subject engaged in non-suicidal self-injurious behavior)."|Day -2, Day 8, and follow-up visit (Day 7 - 14 after last dose of PF-06669571)|All enrolled participants who started treatment.||participants|||Number
636208|NCT02565628|Primary|Maximum Percent Change From Baseline in Movement Disorder Society-Sponsor Revision of the Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part III at Day 7.|The total MDS-UPDRS score is the most common method of evaluating the severity of Parkinson’s disease across behaviors, activities of daily living, motor abilities, and other complications of Parkinson’s disease. The MDS-UPDRS focuses primarily on measuring impairments associated with Parkinson’s disease, with subsections organized according to motor and non-motor aspects of the disease. Part III assesses the motor signs of Parkinson’s disease. Higher total scores indicate more severe motor signs of Parkinson’s disease. Negative changes from baseline indicate improvement. MDS-UPDRS Part III total motor score is comprised of 33 sub-scores based on 18 items, several with right, left or other body distribution scores. Each question is anchored with five responses that are linked to commonly accepted clinical terms: 0 = normal, 1 = slight, 2 = mild, 3 = moderate and 4 = severe.|Day 7|All enrolled participants who started treatment.||Percentage||Standard Error|Least Squares Mean
636209|NCT02565381|Other Pre-specified|Use of Text Messaging Program|Text messaging group only: number who enrolled in SmokefreeTXT, number who replied to query texts sent by SmokefreeTXT.|8 weeks|||Participants|||Count of Participants
636210|NCT02565381|Other Pre-specified|Mobile Phone Retention|Percentage of participants who still have their mobile phone at the end of the study.|8 weeks|||Participants|||Count of Participants
636211|NCT02565381|Other Pre-specified|Recruitment Time|Total time to recruit, enroll, and randomize 75 study participants.|Until target number of participants is reached; anticipate ~6 months|||months|||Number
636212|NCT02565381|Secondary|Nicotine Patch Use|Days of nicotine replacement therapy use in past week, repeatedly measured at the 8 assessment visits occurring on Fridays.|8 weeks|Participants with missing data at a given time point were excluded from calculation of mean past-week patch use at that time point.||Days||Standard Deviation|Mean
636213|NCT02565381|Secondary|Counseling Visit Attendance|Percentage of 8 counseling visits attended.|8 weeks|||percentage of visits||Standard Deviation|Mean
636214|NCT02565381|Secondary|Study Visit Attendance|Percentage of 14 assessment visits attended.|8 weeks|||percentage of visits||Standard Deviation|Mean
636215|NCT02565381|Secondary|Change in Behavioral Health|Past-month drug use severity (score range 0-1), past-month alcohol use severity (score range 0-1), and past-month psychiatric severity (0-1) were each assessed with the Addiction Severity Index (ASI) – 5th Edition, at baseline and at the 10th and 14th study visits. For each ASI measure, higher scores represent greater drug, alcohol, or psychiatric severity. Changes in ASI scores between baseline and 4 or 8 weeks can range from -1 to +1. When interpreting changes in scores, negative values indicate decreases in scores from baseline to 4 or 8 weeks, and positive values indicate increases in scores from baseline to 4 or 8 weeks.|4 weeks and 8 weeks|Participants with missing data at a particular time point are excluded from calculation of mean change in ASI scores at that time point.||units on a scale||Standard Deviation|Mean
636216|NCT02565381|Secondary|Change in Cigarette Consumption|Changes in the average number of cigarettes per day relative to baseline, defined by self-report and repeatedly assessed at the 8 assessment visits occurring on Fridays.|Once per week for 8 weeks|Participants with missing data at a given time point are excluded from calculation of mean changes in cigarette consumption for that time point.||Cigarettes per day||Standard Deviation|Mean
643765|NCT02229513|Secondary|Use of Uterotonic Medications||During surgery and in the PACU (approximately 3 total hours)|||participants|||Number
636218|NCT02565381|Secondary|Percentage of Visits Abstinent of Smoking|Percentage of 14 assessment visits at which a participant is abstinent of smoking, defined as an exhaled carbon monoxide level <8ppm.|8 weeks|Participants with missing data at a given time point were assumed non-abstinent at that time point.||percentage of visits||Standard Deviation|Mean
636219|NCT02565381|Primary|Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks|The primary outcome is a repeated-measures assessment of smoking abstinence, defined as an exhaled carbon monoxide <8ppm and assessed 14 times over the 8-week study period (3 times/week for the first 2 weeks, 2 times/week for the next 2 weeks, and once every week for the last 4 weeks)|Point-in-time abstinence assessed in a repeated fashion 14 times over the 8-week study period|Participants with missing data at a given time point were assumed non-abstinent at that time point.||Participants|||Count of Participants
636220|NCT02563834|Secondary|Myocardial Perfusion Rate|PET measure of total myocardial perfusion (blood flow)|4 Hours|||ml/min/100g||Standard Error|Mean
636221|NCT02563834|Secondary|Myocardial Oxidation Rate|PET measure of total oxidation rate|4 Hours|||ml/min/100g||Standard Error|Mean
636222|NCT02563834|Primary|Myocardial Fatty Acid Uptake Rate|PET measure of fatty acid uptake rate|4 Hours|||umol/min/100g||Standard Error|Mean
636223|NCT02563093|Secondary|Geometric Mean Titer Ratios of Influenza Antibodies Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine|Anti-influenza antibodies were measured using an hemagglutination inhibition assay.|21 days post-vaccination|Anti-influenza antibodies were assessed in the Per-protocol Analysis Set.||Titer ratio||95% Confidence Interval|Geometric Mean
636224|NCT02563093|Secondary|Number of Participants Achieving Seroconversion Following Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine|Anti-influenza antibodies were measured using an hemagglutination inhibition assay. Seroconversion was defined as either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a ≥ 4-fold increase in titer post-vaccination.|21 days post-vaccination|Anti-influenza antibodies were assessed in the Per-protocol Analysis Set.||Participants|||Number
636225|NCT02563093|Secondary|Number of Participants Achieving Seroprotection Pre and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine|Anti-influenza antibodies were measured using an hemagglutination inhibition assay. Seroprotection was defined as the number of participants with a titer ≥ 40 (1/dilution) at pre-vaccination and 21 days post-vaccination.|Day 0 (Pre-vaccination) and 21 days post-vaccination|Anti-influenza antibodies were assessed in the Per-protocol Analysis Set.||Participants|||Number
636226|NCT02563093|Secondary|Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine|Anti-influenza antibodies were measured using an hemagglutination inhibition assay.|Day 0 (pre-vaccination) and 21 days post-vaccination|Anti-influenza antibodies were assessed in the Per-protocol Analysis Set.||Titers (1/dilutions)||95% Confidence Interval|Geometric Mean
636227|NCT02563093|Primary|Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine|"Solicited injection-site reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering. Grade 3 solicited injection-site reactions: Pain, Significant; prevents daily activity. Erythema, Swelling, Induration, and Ecchymosis >100 mm. Grade 3 solicited systemic reactions: Fever, ≥ 39.0°C or ≥ 102.1°F; Headache, Malaise, Myalgia, and Shivering, Significant; prevents daily activity.
A participant (18 to < 65 Years) who was randomly assigned to receive Fluzone Intradermal Quadrivalent vaccine received Fluzone Quadrivalent vaccine instead; this participant was excluded from the Per-protocol analysis Set and was included in the Fluzone Quadrivalent vaccine Group in the Safety Analysis Set and the assigned group in the Full Analysis Set."|Day 0 up to Day 7 post-vaccination|The vaccine safety outcomes were assessed in the Safety Analysis Set. A participant (18 to < 65 Years) who was assigned to receive Fluzone Intradermal Quadrivalent vaccine received Fluzone Quadrivalent vaccine instead; this participant was included in the Fluzone Quadrivalent vaccine (18 to < 65 Years) group in the Safety Analysis Set.||Participants|||Number
636228|NCT02561572|Secondary|Pain Score||24 h postop|Unable to collect data on wards after PACU discharge.|||||
636229|NCT02561572|Secondary|Pain Score in the Postanaesthetic Care Unit (PACU)|The number of patients experiencing moderate/severe pain in PACU.|Immediately postop|||Participants|||Count of Participants
636230|NCT02561572|Secondary|Incidence of Postoperative Nausea and Vomiting (PONV)||24 h postop|Unable to collect data on wards after discharge from PACU|||||
636231|NCT02561572|Secondary|Incidence of Postoperative Nausea and Vomiting (PONV) in the Postanaesthetic Care Unit (PACU)||Within 30 minutes of surgery|||Participants|||Count of Participants
636232|NCT02561572|Secondary|Amsterdam Preoperative Anxiety and Information Scale Scores|The Amsterdam Pre-operative Anxiety and Information Scale has four questions relating to anxiety (APAISa, Table 2) and has been shown to correlate well with the full version of the State-Trait Anxiety Inventory. The scores from the anxiety elements of the questionnaire are added together giving a possible of total score of 4 (low anxiety) to 20 (high anxiety).|30 minutes after intervention|||units on a scale||Inter-Quartile Range|Median
636233|NCT02561572|Primary|State-Trait Anxiety Inventory Score|Patients completed the six item short form of the State-Trait Anxiety Inventory (STAI-S6) in order to assess baseline anxiety levels prior to any intervention. The STAI-S6 is a standardised short form of the 40-item Spielberger State-Trait Anxiety Inventory that has three anxiety-present and three anxiety-absent questions (Table 1). Scores from the STAI-S6 are prorated up to allow comparison with the full version of the questionnaire, with scores ranging from 20 (low anxiety) to 80 (high anxiety). The STAI-S6 has been shown to correlate well with the full version, [12] but is much quicker for participants to complete.|30 minutes after intervention|||units on a scale||Inter-Quartile Range|Median
636234|NCT02559622|Secondary|Change From Baseline in Leptin at Week 4, 12, 24 and 52|Leptin, a soluble biomarker of impaired lipid metabolism was determined in fasting blood samples to evaluate the effect of secukinumab on systemic inflammation.|Baseline, Week 4, 12, 24 and 52|"The analysis was performed in FAS population. Here, Number analyzed signifies participants evaluable for Leptin of impaired lipid metabolism at week 4, 12, 24 and 52 for each arm, respectively"||ng/mL (nanogram per milliliter)||95% Confidence Interval|Mean
636235|NCT02559622|Secondary|Change From Baseline in Adiponectin at Week 4, 12, 24 and 52|Adiponectin, a soluble biomarker of impaired lipid metabolism was determined in fasting blood samples to evaluate the effect of secukinumab on systemic inflammation.|Baseline, Week 4, 12, 24 and 52|"The analysis was performed in FAS population. Here, Number analyzed signifies participants evaluable for Adiponectin of impaired lipid metabolism at week 4, 12, 24 and 52 for each arm, respectively."||ug/mL||95% Confidence Interval|Mean
636236|NCT02559622|Secondary|Change From Baseline in Triglycerides, Total Cholesterol, Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), Apolipoprotein A-1 (ApoA-1) and Apolipoprotein B (ApoB) at Week 4, 12, 24 and 52|Triglycerides, Total cholesterol, Low density lipoprotein (LDL), High density lipoprotein (HDL), Apolipoprotein A-1 (ApoA-1) and Apolipoprotein B (ApoB), soluble biomarkers of impaired lipid metabolism were determined in fasting blood samples to evaluate the effect of secukinumab on impaired lipid metabolism.|Baseline, Week 4, 12, 24 and 52|"The analysis was performed in FAS population. Here, Number analyzed signifies participants evaluable for Triglycerides, Total cholesterol, LDL, HDL, ApoA-1 and ApoB of impaired lipid metabolism at week 4, 12, 24 and 52 for each arm, respectively."||mg/dL||95% Confidence Interval|Mean
636237|NCT02559622|Secondary|Change From Baseline in Sex Hormone-binding Globulin (SHBG) at Week 4, 12, 24 and 52|Sex hormone-binding globulin (SHBG), a soluble biomarker of Dysglycemia was determined in fasting blood samples to evaluate the effect of secukinumab on Dysglycemia.|Baseline, Week 4, 12, 24 and 52|"The analysis was performed in FAS population. Here, Number analyzed signifies participants evaluable for SHBG of Dysglycemia at week 4, 12, 24 and 52 for each arm, respectively."||nanomole per Liter (nmol/L)||95% Confidence Interval|Mean
636238|NCT02559622|Secondary|Change From Baseline in Hemoglobin A1c (Glycated Hemoglobin) at Week 4, 12, 24 and 52|Hemoglobin A1c (glycated hemoglobin), a soluble biomarker of Dysglycemia was determined in fasting blood samples to evaluate the effect of secukinumab on Dysglycemia.|Baseline, Week 4, 12, 24 and 52|"The analysis was performed in FAS population. Here, Number analyzed signifies participants evaluable for Hemoglobin A1c of Dysglycemia at week 4, 12, 24 and 52 for each arm, respectively."||millimole per mole of Haemoglobin||95% Confidence Interval|Mean
636239|NCT02559622|Secondary|Change From Baseline in Homeostatic Model Assessment (HOMA) Insulin Resistance at Week 4, 12, 24 and 52|HOMA insulin resistance, a soluble biomarker of Dysglycemia was determined in fasting blood samples to evaluate the effect of secukinumab on Dysglycemia.|Baseline, Week 4, 12, 24 and 52|"The analysis was performed in FAS population. Here, Number analyzed signifies participants evaluable for HOMA insulin resistance of Dysglycemia at week 4, 12, 24 and 52 for each arm, respectively."||Insulin Resistance Index||95% Confidence Interval|Mean
636240|NCT02559622|Secondary|Change From Baseline in Homeostatic Model Assessment (HOMA) Beta-cell Function at Week 4, 12, 24 and 52|Homeostatic Model Assessment (HOMA) beta-cell function, a soluble biomarker of Dysglycemia was determined in fasting blood samples to evaluate the effect of secukinumab on Dysglycemia.|Baseline, Week 4, 12, 24 and 52|"The analysis was performed in FAS population. Here, Number analyzed signifies participants evaluable for HOMA beta-cell function of Dysglycemia at week 4, 12, 24 and 52 for each arm, respectively."||Percentage||95% Confidence Interval|Mean
636241|NCT02559622|Secondary|Change From Baseline in Fasting Insulin at Week 4, 12, 24 and 52|Fasting Insulin, a soluble biomarker of Dysglycemia was determined in fasting blood samples to evaluate the effect of secukinumab on Dysglycemia.|Baseline, Week 4, 12, 24 and 52|"The analysis was performed in FAS population. Here, Number analyzed signifies participants evaluable for Fasting Insulin of Dysglycemia at week 4, 12, 24 and 52 for each arm, respectively."||micro units per millilitre (uU/mL)||95% Confidence Interval|Mean
636242|NCT02559622|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 4, 12, 24 and 52|Fasting plasma glucose (FPG), a soluble biomarker of Dysglycemia was determined in fasting blood samples to evaluate the effect of secukinumab on systemic inflammation.|Baseline, Week 4, 12, 24 and 52|"The analysis was performed in FAS population. Here, Number analyzed signifies participants evaluable for FPG at week 4, 12, 24 and 52 for each arm, respectively."||mg/dL||95% Confidence Interval|Mean
636243|NCT02559622|Secondary|Change From Baseline in Chemokine (C-c Motif) Ligand 5 (CCL5), Monocyte Chemoattractant Protein 1 (MCP-1) and Macrophage Inflammatory Proteins (MIP) 1 Alpha and 1 Beta at Week 4, 12, 24 and 52|Chemokine (c-c motif) ligand 5 (CCL5), Monocyte chemoattractant protein 1 (MCP-1) and Macrophage inflammatory proteins (MIP) 1 alpha (1A) and 1 beta (1B), soluble biomarkers of systemic inflammation were determined in fasting blood samples to evaluate the effect of secukinumab on systemic inflammation.|Baseline, Week 4, 12, 24 and 52|"The analysis was performed in FAS population. Here, Number analyzed signifies participants evaluable for CCL5, MCP-1, MIP-1A and MIP-1B at week 4, 12, 24 and 52 for each arm, respectively."||picograms per milliliter (pg/mL)||95% Confidence Interval|Mean
636244|NCT02559622|Secondary|Change From Baseline in S-100 Protein B (Total) at Week 4, 12, 24 and 52|S100 calcium-binding protein B (S100B-protein), a soluble biomarker of systemic inflammation was determined in fasting blood samples to evaluate the effect of secukinumab on systemic inflammation.|Baseline, Week 4, 12, 24 and 52|"The analysis was performed in FAS population. Here, Number analyzed signifies participants evaluable for S100B-protein at week 4, 12, 24 and 52 for each arm, respectively."||Microgram per Liter (ug/L)||95% Confidence Interval|Mean
636245|NCT02559622|Secondary|Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Week 4, 12, 24 and 52|High sensitivity C-reactive protein (hsCRP), a soluble biomarker of systemic inflammation was determined in fasting blood samples to evaluate the effect of secukinumab on systemic inflammation.|Baseline, Week 4, 12, 24 and 52|"The analysis was performed in FAS population. Here, Number analyzed signifies participants evaluable for hsCRP at week 4, 12, 24 and 52 for each arm, respectively."||Milligrams per deciliter (mg/dL)||95% Confidence Interval|Mean
636246|NCT02559622|Secondary|Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 52|Magnetic resonance imaging (MRI) was used to evaluate vessel wall morphometry to determine plaque burden. As a measure of plaque burden, average wall area was computed by subtracting vessel lumen area from total vessel area. Exploratory 3.0 Tesla MRI technique was applied to assess structure and function of the carotid and the aorta. A 2D axial dark blood T1, T2, proton density weighted spin echo based images and time of flight images were acquired from the bilateral carotid arteries as well as the descending aorta.|Baseline, Week 52|"The analysis was performed in FAS population. Here, Number analyzed signifies participants evaluable for MRI sub-study at week 52 for each arm, respectively. MRI was applied in a sub-study population of 33 participants."||mm^2||95% Confidence Interval|Mean
636247|NCT02559622|Secondary|Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 12|Magnetic resonance imaging (MRI) was used to evaluate vessel wall morphometry to determine plaque burden. As a measure of plaque burden, average wall area was computed by subtracting vessel lumen area from total vessel area. Exploratory 3.0 Tesla MRI technique was applied to assess structure and function of the carotid and the aorta. A 2D axial dark blood T1, T2, proton density weighted spin echo based images and time of flight images were acquired from the bilateral carotid arteries as well as the descending aorta.|Baseline, Week 12|"The analysis was performed in FAS population. Here, Number analyzed signifies participants evaluable for MRI sub-study at week 12 for each arm, respectively. MRI was applied in a sub-study population of 33 participants."||millimeter square (mm^2)||95% Confidence Interval|Mean
636248|NCT02559622|Secondary|Change From Baseline in Pulse Wave Velocity (PWV) at Week 4, 12, 24 and 52|Regional arterial pulse wave velocity (PWV) was directly related to arterial stiffness and was defined as the time it takes for the blood pressure wave to travel from a proximal site to a distal site (relative to the heart) divided by the distance (PWV = ∆distance/∆time [m/s]). The foot of the arterial pulse wave was being recorded by using the SphygmoCor XCEL device. XCEL simultaneously measures the pressure waveform at the femoral site (using a partially inflated custom blood pressure cuff) and the carotid site (using hand-held applanation tonometry). The foot-to-foot time between the two pressure waveforms was the time interval used in the PWV calculation.|Baseline, Week 4, 12, 24 and 52|"The analysis was performed in FAS population. Here, n signifies the sum of participants for all repeated measurements during calculation of mean, evaluable for pulse wave velocity (PWV) at Week 4, 12, 24 and 52 for each arm, respectively."||meters per second (m/s)||95% Confidence Interval|Mean
636249|NCT02559622|Secondary|Change From Baseline in Aortic Augmentation Index at Heart Rate of 75 (AIx-75) at Week 4, 12, 24 and 52|Pulse wave analysis was performed on the central aortic pressure waveform as derived by SphygmoCor XCEL from the brachial pressure waveform recorded in a partially-inflated blood pressure cuff around the upper arm. The waveform derivation employs a validated generalized transfer function to convert a brachial waveform to a central waveform and has been shown to produce measurement results corresponding to measurements using intra-arterial pressure catheters. The augmentation index is derived from the waveform by determining the percentage of the central pulse pressure during systole due to wave reflection. AIx was heart-rate corrected to calculate the AIx at a heart rate of 75 bpm, i.e. AIx-75.|Baseline, Week 4, 12, 24 and 52|"The analysis was performed in FAS population. Here, Number analyzed signifies participants evaluable for pulse wave analysis at weeks 4, 12, 24 and 52 for each arm, respectively."||Percentage change in Alx-75||95% Confidence Interval|Mean
636250|NCT02559622|Secondary|Change From Baseline in Flow Mediated Dilation (FMD) at Week 4, 12, 24 and 52|FMD is non-invasive method evaluated by Doppler Ultrasound test, to assess endothelial function. FMD was calculated as the percent maximal deviation from the baseline arterial diameter (D):FMD = 100*[(D maximum – D baseline) / D baseline]. Here, arterial diameter (brachial artery) was measured at rest (1 minute), during inflation of the distal cuff to 100 mmHg for 4.5 minutes and for 4.5 minutes following deflation. A positive change in FMD constitutes an improvement in endothelial function.|Baseline, Week 4, 12, 24 and 52|"The analysis was performed in FAS population. Here, Number analyzed signifies participants evaluable for FMD at weeks 4, 12, 24 and 52 for each arm, respectively."||Percentage change in FMD||95% Confidence Interval|Mean
636251|NCT02559622|Primary|Flow Mediated Dilation (FMD) at Week 12 Followed by Secukinumab 300 mg vs Pooled Placebo Treatment|Flow Mediated Dilation (FMD) is non-invasive method evaluated by Doppler Ultrasound test, to assess endothelial function. FMD was calculated as the percent maximal deviation from the baseline arterial diameter (D):FMD = 100*[(D maximum – D baseline) / D baseline]. Here, arterial diameter (brachial artery) was measured at rest (1 minute), during inflation of the distal cuff to 100 millimeter of mercury (mmHg) for 4.5 minutes and for 4.5 minutes following deflation.|Week 12|"The analysis was performed in Full analysis set (FAS) population, defined as all participants from the randomized set who received at least one dose of study drug. Here, Number analyzed signifies participants evaluable for FMD at Week 12 for each arm, respectively."||Percentage maximal increase in diameter||Standard Deviation|Mean
636252|NCT02559414|Secondary|Endothelial Function as Measured by Its Change From Baseline to Follow-up in Activation Following the Co-culture of Platelets With Human Endothelial Cells, and the Extraction of mRNA From Human Endothelial Cells by Polymerase Chain Reaction.|Secondary objectives will compare the effect of each antiplatelet therapy drug on biomarkers related to endothelial function.|14 Days||||||
636253|NCT02559414|Secondary|Immune Activity as Measured by the Change in Biomarkers From Baseline to Follow-up Identified Via Flow Cytometry and Hematological Analysis.|Secondary objectives will compare the effect of each antiplatelet therapy drug on biomarkers related to immune activity|14 Days||||||
636254|NCT02559414|Secondary|Inflammation as Measured by the Change in Biomarker From Baseline to Follow-up Identified Via Hematological Analysis.|Secondary objectives will compare the effect of each antiplatelet therapy drug on biomarkers related to inflammation|14 Days||||||
636255|NCT02559414|Secondary|Percentage Platelet Aggregation in PRP After Stimulation With ADP 5μM for 5 Min||14 Days|||%aggregation||Standard Error|Mean
636256|NCT02559414|Primary|Percentage Platelet Aggregation in PRP After Stimulation With Arachidonic Acid 1600 μM for 5 Min|The primary objective of these analyses will be to compare the effects of aspirin versus control and clopidogrel versus control for the outcome of platelet activity. Aspirin is expected to decrease arachidonic acid-induced platelet aggregation by 50% versus control. Clopidogrel is expected to decrease ADP-induced platelet aggregation by 50% versus control.|14 Days|||%aggregation||Standard Error|Mean
636257|NCT02557698|Secondary|Skin Surface pH at the Left Midvolar Forearm|Skin surface pH was measured using the Skin-pH-Meter PH905 (Courage+Khazaka, Cologne, Germany) according to international guidelines (Parra et al. 2003). The pH on the skin surface may differ from the pH of the stratum corneum. Means of triple measurements/images per skin area.|Day 28 +/- 3|||non-dimensional||Standard Deviation|Mean
636258|NCT02557698|Secondary|Skin Surface pH at the Left Midvolar Forearm|Skin surface pH was measured using the Skin-pH-Meter PH905 (Courage+Khazaka, Cologne, Germany) according to international guidelines (Parra et al. 2003). The pH on the skin surface may differ from the pH of the stratum corneum. Means of triple measurements/images per skin area.|Day 14 +/- 2|||non-dimensional||Standard Deviation|Mean
637708|NCT02475031|Secondary|Nausea Scores at 48 Hours|Post-operative nausea scores will be recorded at 48 hours. Range of nausea score is 0-3. 0= None, 1=Mild, 2=Moderate, 3=Severe.|up to 48 hours|||units on a scale||Standard Error|Mean
636259|NCT02557698|Secondary|Skin Surface Mean Roughness (Rz) in µm at the Left Midvolar Forearm|Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany) device. It consists of a UV light camera and measures the skin surface profiles. The parameter Rz was calculated. Rz=mean roughness of five equally spaced sampling lenghts.|Day 28 +/- 3|||µm||Standard Deviation|Mean
636260|NCT02557698|Secondary|Skin Surface Mean Roughness (Rz) in µm at the Left Midvolar Forearm|Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany) device. It consists of a UV light camera and measures the skin surface profiles. The parameter Rz was calculated. Rz=mean roughness of five equally spaced sampling lenghts.|Day 14 +/- 2|||µm||Standard Deviation|Mean
636261|NCT02557698|Secondary|Skin Surface Mean Roughness (Ra) in µm at the Left Midvolar Forearm|Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Ra=mean roughness|Day 28 +/- 3|||µm||Standard Deviation|Mean
636262|NCT02557698|Secondary|Skin Surface Mean Roughness (Ra) in µm at the Left Midvolar Forearm|Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Ra=mean roughness|Day 14 +/- 2|||µm||Standard Deviation|Mean
636263|NCT02557698|Secondary|Stratum Corneum Hydration (SCH) in Arbitrary Units at the Left Midvolar Forearm|"SCH was measured using the Corneometer (Courage+Khazaka, Cologne, Germany) according to international guidelines which measured the hydratation level of the stratum corneum as electrical capacitance (Berardesca et al. 1997). The higher the values, the higher the SCH. Per investigational site three replicate measurements were carried out.
Visit 3 (day 28)"|Day 28 +/- 3|||Arbitrary Units||Standard Deviation|Mean
636264|NCT02557698|Secondary|Stratum Corneum Hydration (SCH) in Arbitrary Units at the Left Midvolar Forearm|"SCH was measured using the Corneometer (Courage+Khazaka, Cologne, Germany) according to international guidelines which measured the hydratation level of the stratum corneum as electrical capacitance (Berardesca et al. 1997). The higher the values, the higher the SCH. Per investigational site three replicate measurements were carried out.
Visit 2 (day 14)"|Day 14 +/- 2|||Arbitrary Units||Standard Deviation|Mean
636265|NCT02557698|Secondary|Overall Dry Skin (ODS) Score at the Trunk|"The Overall Dry Skin score is a standardized instrument to clinically assess the presence or severity of skin dryness using a five point rating scale according to Serup1995, Kang et al. 2014 on both arms, lower legs and trunk.
(0=Absent, 1=Faint scaling, faint roughness and dull appearance, 2=Small scales in combination with a few larger scales, slight roughness and whitish appearance, 3=Small and larger scales uniformly distributed, definite roughness, possibly slight redness and possibly a few superficial cracks, 4=Dominated by large scales, advanced roughness, redness present, eczematous changes and cracks) Visit 3 (day 28) - end of study visit"|Day 28 +/- 3|ODS score 0-4||Participants|||Count of Participants
636266|NCT02557698|Secondary|Overall Dry Skin (ODS) Score at the Trunk|"The Overall Dry Skin score is a standardized instrument to clinically assess the presence or severity of skin dryness using a five point rating scale according to Serup1995, Kang et al. 2014 on both arms, lower legs and trunk.
(0=Absent, 1=Faint scaling, faint roughness and dull appearance, 2=Small scales in combination with a few larger scales, slight roughness and whitish appearance, 3=Small and larger scales uniformly distributed, definite roughness, possibly slight redness and possibly a few superficial cracks, 4=Dominated by large scales, advanced roughness, redness present, eczematous changes and cracks) Visit 2 (day 14)"|Day 14 +/- 2|ODS score 0-4||Participants|||Count of Participants
636267|NCT02557698|Secondary|Overall Dry Skin (ODS) Score at the Right Lower Leg|"The Overall Dry Skin score is a standardized instrument to clinically assess the presence or severity of skin dryness using a five point rating scale according to Serup1995, Kang et al. 2014 on both arms, lower legs and trunk.
(0=Absent, 1=Faint scaling, faint roughness and dull appearance, 2=Small scales in combination with a few larger scales, slight roughness and whitish appearance, 3=Small and larger scales uniformly distributed, definite roughness, possibly slight redness and possibly a few superficial cracks, 4=Dominated by large scales, advanced roughness, redness present, eczematous changes and cracks) Visit 3 (day 28)"|Day 28 +/- 3|ODS score 0-4||Participants|||Count of Participants
636268|NCT02557698|Secondary|Overall Dry Skin (ODS) Score at the Right Lower Leg|"The Overall Dry Skin score is a standardized instrument to clinically assess the presence or severity of skin dryness using a five point rating scale according to Serup1995, Kang et al. 2014 on both arms, lower legs and trunk.
(0=Absent, 1=Faint scaling, faint roughness and dull appearance, 2=Small scales in combination with a few larger scales, slight roughness and whitish appearance, 3=Small and larger scales uniformly distributed, definite roughness, possibly slight redness and possibly a few superficial cracks, 4=Dominated by large scales, advanced roughness, redness present, eczematous changes and cracks) Visit 2 (day 14) - intermediate visit"|Day 14 +/- 2|ODS score 0-4||Participants|||Count of Participants
636269|NCT02557698|Secondary|Overall Dry Skin (ODS) Score at the Left Lower Leg|"The Overall Dry Skin score is a standardized instrument to clinically assess the presence or severity of skin dryness using a five point rating scale according to Serup1995, Kang et al. 2014 on both arms, lower legs and trunk.
(0=Absent, 1=Faint scaling, faint roughness and dull appearance, 2=Small scales in combination with a few larger scales, slight roughness and whitish appearance, 3=Small and larger scales uniformly distributed, definite roughness, possibly slight redness and possibly a few superficial cracks, 4=Dominated by large scales, advanced roughness, redness present, eczematous changes and cracks) Visit 3 (day 28) - end of study visit"|Day 28 +/- 3|ODS score 0-4||Participants|||Count of Participants
636270|NCT02557698|Secondary|Overall Dry Skin (ODS) Score at the Left Lower Leg|"The Overall Dry Skin score is a standardized instrument to clinically assess the presence or severity of skin dryness using a five point rating scale according to Serup1995, Kang et al. 2014 on both arms, lower legs and trunk.
(0=Absent, 1=Faint scaling, faint roughness and dull appearance, 2=Small scales in combination with a few larger scales, slight roughness and whitish appearance, 3=Small and larger scales uniformly distributed, definite roughness, possibly slight redness and possibly a few superficial cracks, 4=Dominated by large scales, advanced roughness, redness present, eczematous changes and cracks) Visit 2 (day 14) - intermediate visit"|Day 14 +/- 2|ODS score 0-4||Participants|||Count of Participants
636322|NCT02555722|Primary|Bulbar Hyperemia - Enfilcon A Lens (Control)|Bulbar hyperemia is assessed for enfilcon A lens (control). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3|||percentage of eyes|Eyes||Number
643766|NCT02229513|Secondary|Change in Pre- vs Post-operative Hematocrit||48 hours post operative period|||percent||Standard Deviation|Mean
636271|NCT02557698|Secondary|Overall Dry Skin (ODS) Score at the Right Arm|"The Overall Dry Skin score is a standardized instrument to clinically assess the presence or severity of skin dryness using a five point rating scale according to Serup1995, Kang et al. 2014 on both arms, lower legs and trunk.
(0=Absent, 1=Faint scaling, faint roughness and dull appearance, 2=Small scales in combination with a few larger scales, slight roughness and whitish appearance, 3=Small and larger scales uniformly distributed, definite roughness, possibly slight redness and possibly a few superficial cracks, 4=Dominated by large scales, advanced roughness, redness present, eczematous changes and cracks) Visit 3 (day 28)"|Day 28 +/- 3|ODS score 0-4||Participants|||Count of Participants
636272|NCT02557698|Secondary|Overall Dry Skin (ODS) Score at the Right Arm|"The Overall Dry Skin score is a standardized instrument to clinically assess the presence or severity of skin dryness using a five point rating scale according to Serup1995, Kang et al. 2014 on both arms, lower legs and trunk.
(0=Absent, 1=Faint scaling, faint roughness and dull appearance, 2=Small scales in combination with a few larger scales, slight roughness and whitish appearance, 3=Small and larger scales uniformly distributed, definite roughness, possibly slight redness and possibly a few superficial cracks, 4=Dominated by large scales, advanced roughness, redness present, eczematous changes and cracks) Visit 2 (day14)"|Day 14 +/- 2|ODS score 0-4||Participants|||Count of Participants
636273|NCT02557698|Secondary|Overall Dry Skin (ODS) Score at the Left Arm|"The Overall Dry Skin score is a standardized instrument to clinically assess the presence or severity of skin dryness by the investigator using a five point rating scale according to Serup1995, Kang et al. 2014 on both arms, lower legs and trunk.
(0=Absent, 1=Faint scaling, faint roughness and dull appearance, 2=Small scales in combination with a few larger scales, slight roughness and whitish appearance, 3=Small and larger scales uniformly distributed, definite roughness, possibly slight redness and possibly a few superficial cracks, 4=Dominated by large scales, advanced roughness, redness present, eczematous changes and cracks)"|Day 28 +/- 3|||Participants|||Count of Participants
636274|NCT02557698|Secondary|Overall Dry Skin (ODS) Score at the Left Arm|"The Overall Dry Skin score is a standardized instrument to clinically assess the presence or severity of skin dryness using a five point rating scale according to Serup1995, Kang et al. 2014 on both arms, lower legs and trunk.
(0=Absent, 1=Faint scaling, faint roughness and dull appearance, 2=Small scales in combination with a few larger scales, slight roughness and whitish appearance, 3=Small and larger scales uniformly distributed, definite roughness, possibly slight redness and possibly a few superficial cracks, 4=Dominated by large scales, advanced roughness, redness present, eczematous changes and cracks) Visit 2 (day14) - intermediate visit"|Day 14 +/- 2|ODS score 0-4||Participants|||Count of Participants
636275|NCT02557698|Secondary|Skin Surface pH at the Right Lateral Lower Leg|Skin surface pH was measured using the Skin-pH-Meter PH905 (Courage+Khazaka, Cologne, Germany) according to international guidelines (Parra et al. 2003). The pH of the skin surface may differ from the pH of the stratum corneum. Means of triple measurements/images per skin area.|Day 28 +/- 3|||non-dimensional||Standard Deviation|Mean
636276|NCT02557698|Secondary|Skin Surface pH at the Right Lateral Lower Leg|Skin surface pH was measured using the Skin-pH-Meter PH905 (Courage+Khazaka, Cologne, Germany) according to international guidelines (Parra et al. 2003). The pH of the skin surface may differ from the pH of the stratum corneum. Means of triple measurements/images per skin area.|Day 14 +/- 2|||non-dimensional||Standard Deviation|Mean
636277|NCT02557698|Secondary|Skin Surface Mean Roughness (Rz) in µm at the Right Lateral Lower Leg|Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany) device. It consists of a UV light camera and measures the skin surface profiles. The parameter Rz was calculated. Rz=mean roughness of five equally spaced sampling lenghts.|Day 28 +/- 3|||µm||Standard Deviation|Mean
636278|NCT02557698|Secondary|Skin Surface Mean Roughness (Rz) in µm at the Right Lateral Lower Leg|Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany) device. It consists of a UV light camera and measures the skin surface profiles. The parameter Rz was calculated. Rz=mean roughness of five equally spaced sampling lenghts.|Day 14 +/- 2|||µm||Standard Deviation|Mean
636279|NCT02557698|Secondary|Skin Surface Mean Roughness (Ra) in µm at the Right Lateral Lower Leg|Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Ra=mean roughness|Day 28 +/- 3|||µm||Standard Deviation|Mean
636280|NCT02557698|Secondary|Skin Surface Mean Roughness (Ra) in µm at the Right Lateral Lower Leg|Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Ra=mean roughness|Day 14 +/- 2|||µm||Standard Deviation|Mean
636281|NCT02557698|Secondary|Stratum Corneum Hydration (SCH) in Arbitrary Units at the Right Lateral Lower Leg|"SCH was measured using the Corneometer (Courage+Khazaka, Cologne, Germany) according to international guidelines which measured the hydratation level of the stratum corneum as electrical capacitance (Berardesca et al. 1997). The higher the values, the higher is SCH. Per investigational site three replicate measurements were carried out.
Visit 3 (day 28)"|Day 28 +/- 3|||Arbitrary Units||Standard Deviation|Mean
636282|NCT02557698|Secondary|Stratum Corneum Hydration (SCH) in Arbitrary Units at the Right Lateral Lower Leg|"SCH was measured using the Corneometer (Courage+Khazaka, Cologne, Germany) according to international guidelines which measured the hydratation level of the stratum corneum as electrical capacitance (Berardesca et al. 1997). The higher the values, the higher the SCH. Per investigational site three replicate measurements were carried out.
Visit 2 (day 14)"|Day 14 +/- 2|||Arbitrary Units||Standard Deviation|Mean
636283|NCT02557698|Secondary|Transepidermal Water Loss (TEWL) in g/m2/h at the Right Lateral Lower Leg|"TEWL was measured using the Tewameter TM300 (Courage+Khazaka, Cologne, Germany) according to international guidelines (Rogiers 2001). This open chamber intrument measured water evaporation from the skin by temperature and humidity sensors inside the cylinder. Means of triple measurements per skin area in g/m2/h at the right lateral lower leg.
Visit 3 (day 28)"|Day 28 +/- 3|||g/m2/h||Standard Deviation|Mean
636284|NCT02557698|Secondary|Transepidermal Water Loss (TEWL) in g/m2/h at the Right Lateral Lower Leg|"TEWL was measured using the Tewameter TM300 (Courage+Khazaka, Cologne, Germany) according to international guidelines (Rogiers 2001). This open chamber intrument measured water evaporation from the skin by temperature and humidity sensors inside the cylinder. Means of triple measurements per skin area in g/m2/h at the right lateral lower leg.
Visit 2 (day14)"|Day 14 +/- 2|||g/m2/h||Standard Deviation|Mean
640370|NCT02354924|Secondary|Slit Lamp Findings|Any slit lamp finding > Grade 2; Measured on a scale of 0-4 with 0=no findings and 4=severe findings|3 month|||eye|eye||Count of Units
636285|NCT02557698|Secondary|Transepidermal Water Loss (TEWL) in g/m2/h at the Left Mid Volar Forearm|"TEWL was measured using the Tewameter TM300 (Courage+Khazaka, Cologne, Germany) according to international guidelines (Rogiers 2001). This open chamber intrument measured water evaporation from the skin by temperature and humidity sensors inside the cylinder. Means of triple measurements per skin area in g/m2/h on the left midvolar forearm.
Visit 2 (day14) - intermediate visit"|Day 14 +/- 2|||g/m2/h||Standard Deviation|Mean
636286|NCT02557698|Primary|Transepidermal Water Loss (TEWL) in g/m2/h at the Left Mid Volar Forearm|"TEWL was measured using the Tewameter TM300 (Courage+Khazaka, Cologne, Germany) according to international guidelines (Rogiers 2001). This open chamber intrument measured water evaporation from the skin by temperature and humidity sensors inside the cylinder. Means of triple measurements per skin area in g/m2/h on the left midvolar forearm.
Visit 3 (day 28) - end of study visit"|Day 28 +/- 3|Male or female gender, aged between 6 months and 85 years||g/m2/h||Standard Deviation|Mean
636287|NCT02557646|Secondary|Percentage of Participants With Viral Relapse or Breakthrough According to Dose Reduction of Ribavirin|Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. In participants with virological response, positive HCV titers measured during 24-week follow-up was interpreted as viral relapse, and positive HCV titers measured during the treatment period was interpreted as viral breakthrough. Percentage of participants with no relapse/breakthrough (none), with relapse, and with breakthrough in each dose-reduction group (none, dose reduction within 12 weeks, dose reduction after 12 weeks, dose reduction not specified) is presented.|Up to 24 weeks after EOT (maximum up to 96 weeks)|ITT Population showing virological response. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure.||percentage of participants|||Number
636288|NCT02557646|Secondary|Percentage of Participants With Viral Relapse or Breakthrough According to Body Weight-normalized Dose of Ribavirin|Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. In participants with virological response, positive HCV titers measured during 24-week follow-up was interpreted as viral relapse, and positive HCV titers measured during the treatment period was interpreted as viral breakthrough. Percentage of participants with no relapse/breakthrough (none), with relapse, and with breakthrough in each body weight-normalized dose group (<5mg/kg/day, 5-10 mg/kg/day, 10-15 mg/kg/day, 15-20 mg/kg/day, and >20 mg/kg/day) is presented.|Up to 24 weeks after EOT (maximum up to 96 weeks)|ITT Population showing virological response. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure.||percentage of participants|||Number
636289|NCT02557646|Secondary|Percentage of Participants With Viral Relapse or Breakthrough According to Starting Dose of Ribavirin|Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. In participants with virological response, positive HCV titers measured during 24-week follow-up was interpreted as viral relapse, and positive HCV titers measured during the treatment period was interpreted as viral breakthrough. Percentage of participants with no relapse/breakthrough (none), with relapse, and with breakthrough in each dose group (600 mg, 800 mg, 1000 mg, 1200 mg, and 1400 mg) is presented.|Week 4, 12, 24, at EOT Visit, 24 weeks after EOT (maximum up to 96 weeks)|ITT Population showing virological response. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure.||percentage of participants|||Number
636290|NCT02557646|Secondary|Percentage of Participants With Viral Relapse or Breakthrough According to Cumulative Dose of Ribavirin|Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. In participants with virological response, positive HCV titers measured during 24-week follow-up was interpreted as viral relapse, and positive HCV titers measured during the treatment period was interpreted as viral breakthrough. Percentage of participants with viral relapse or breakthrough in each cumulative dose group is presented. Cumulative dose was calculated as: (administered dose divided by planned dose) multiplied by 100. Percentage of participants with no relapse/breakthrough (none), with relapse, and with breakthrough in each cumulative dose group (<60%, 60-69%, 70-79%, 80-89%, and >90%) is reported.|Up to 24 weeks after EOT (maximum up to 96 weeks)|ITT Population showing virological response. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure.||percentage of participants|||Number
636291|NCT02557646|Secondary|Percentage of Participants With Viral Relapse or Breakthrough|Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. In participants with virological response, positive HCV titers measured during 24-week follow-up was interpreted as viral relapse, and positive HCV titers measured during the treatment period was interpreted as viral breakthrough. Percentage of participants with no relapse/breakthrough (none), with relapse, and with breakthrough is reported.|Up to 24 weeks after EOT (maximum up to 96 weeks)|ITT Population showing virological response. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure.||percentage of participants|||Number
636292|NCT02557646|Secondary|Percentage of Participants With SVR According to IL-28B Polymorphism|Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24 and at EOT were interpreted as virological response, and negative HCV titers measured at the end of the 24-week follow-up period were interpreted as SVR. Percentage of participants achieving SVR for each IL-28B allele (CC allele, CT allele, TT allele) is presented.|24 weeks after EOT (maximum up to 96 Weeks)|ITT Population. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category.||percentage of participants|||Number
636323|NCT02555722|Primary|Bulbar Hyperemia - Fanfilcon A Lens (Test)|Bulbar hyperemia is assessed for fanfilcon A lens (test). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3|||percentage of eyes|Eyes||Number
640371|NCT02354924|Primary|Visual Acuity|Visual acuity correctable to snellen 20/25 or better|3 months|||eye|eye||Count of Units
636293|NCT02557646|Secondary|Percentage of Participants With Virologic Response According to Interleukin-28B (IL-28B) Polymorphism|Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24 and at EOT were interpreted as virological response. Percentage of participants achieving virological response for each IL-28B allele (CC allele, CT allele, TT allele) is presented.|Up to EOT (maximum up to 72 weeks)|ITT Population. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category.||percentage of participants|||Number
636294|NCT02557646|Secondary|Percentage of Participants With SVR According to Dose Reduction of Ribavirin|Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24 and at EOT were interpreted as virological response, and negative HCV titers measured at the end of the 24-week follow-up period were interpreted as SVR. Percentage of participants achieving SVR in each dose-reduction group (none, dose reduction within 12 weeks, dose reduction after 12 weeks, dose reduction not specified) is presented.|24 weeks after EOT (maximum up to 96 weeks)|ITT Population. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category.||percentage of participants|||Number
636295|NCT02557646|Secondary|Percentage of Participants With Virologic Response According to Dose Reduction of Ribavirin|Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24, and at EOT were interpreted as virological response. Percentage of participants achieving virological response in each dose-reduction group (none, dose reduction within 12 weeks, dose reduction after 12 weeks, dose reduction not specified) is presented.|Up to EOT (maximum up to 72 weeks)|ITT Population.||percentage of participants|||Number
636296|NCT02557646|Secondary|Percentage of Participants With SVR According to Body Weight-normalized Dose of Ribavirin|Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24, and at EOT were interpreted as virological response, and negative HCV titers measured at the end of the 24-week follow-up period were interpreted as SVR. Percentage of participants achieving SVR in each body weight-normalized dose group is presented.|24 weeks after EOT (maximum up to 96 weeks)|ITT Population. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category.||percentage of participants|||Number
636297|NCT02557646|Secondary|Percentage of Participants With Virologic Response According to Body Weight-normalized Dose of Ribavirin|Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24, and at EOT were interpreted as virological response. Percentage of participants achieving virological response in each body weight-normalized (measured in milligram per kilogram per day [mg/kg/day]) dose group is presented.|Up to EOT (maximum up to 72 weeks)|ITT Population. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category.||percentage of participants|||Number
636298|NCT02557646|Secondary|Percentage of Participants With SVR According to Starting Dose of Ribavirin|Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24, and at EOT were interpreted as virological response, and negative HCV titers measured at the end of the 24-week follow-up period were interpreted as SVR. Percentage of participants achieving SVR in each dose group is presented.|24 weeks after EOT (maximum up to 96 weeks)|ITT Population. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category.||percentage of participants|||Number
636299|NCT02557646|Secondary|Percentage of Participants With Virologic Response According to Starting Dose of Ribavirin|Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24 and at EOT were interpreted as virological response. Percentage of participants achieving virological response in each dose group is presented.|Up to EOT (maximum up to 72 weeks)|ITT Population. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category.||percentage of participants|||Number
636300|NCT02557646|Secondary|Percentage of Participants With Virologic Response|Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24 and at EOT were interpreted as virological response.|Week 4, 12, 24 and at EOT (maximum up to 72 weeks)|ITT Population.||percentage of participants|||Number
636301|NCT02557646|Primary|Percentage of Participants Achieving Sustained Virological Response (SVR) According to Cumulative Dose of Ribavirin|Determination of hepatitis C virus (HCV) titers was performed using COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C, at Weeks 4, 12 and 24 of the treatment period (and, optionally, at the end of treatment [EOT] visit), and at the end of the 24-week follow-up period. Negative HCV titers measured at Weeks 4, 12, 24, and at EOT were interpreted as virological response, and negative HCV titers measured at the end of the 24-week follow-up period were interpreted as SVR. Percentage of participants achieving SVR in each cumulative dose group is presented. Cumulative dose was calculated as: (administered dose divided by planned dose) multiplied by 100.|24 weeks after EOT (maximum up to 96 Weeks)|ITT Population. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category.||percentage of participants|||Number
636302|NCT02557555|Primary|Survey to Determine Utility and Effect of Educational Materials|In order to assess the educational value of the pamphlet provided to parturients we evaluated all the questions pertaining education. There is no nominal value reported in units as all the data is merely described as the percentage of patients responding to educational questions. For example, 93% of patients (91/98) responded Yes to the question -Do you think the pamphlet you received did a better job explaining your options for control of labor pain than what you answered in the previous question <patient research>?|expected average of no later than 48 hours following delivery|The answers from 100 female patients, ages 18-45 admitted to the L&D who answered our survey were analyzed to gage the educational value of our labor analgesia informational pamphlet.||percentage of patients responding|||Number
636303|NCT02556307|Secondary|Treatment Duration (in Weeks) With Peginterferon Alfa-2a and Ribavirin||Up to 99.6 Weeks|All treated participants were included.||weeks||Standard Deviation|Mean
636304|NCT02556307|Secondary|Hemoglobin Values||Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks)|"Number of participants analyzed=treated participants with data available for hemoglobin. Here, n specifies number of participants with data available for specified category."||gram per liter||Standard Deviation|Mean
636305|NCT02556307|Secondary|Leukocyte Values||Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks)|"Number of participants analyzed=treated participants with data available for leukocyte value. Here, n specifies number of participants with data available for specified category."||billion cells per liter||Standard Deviation|Mean
636306|NCT02556307|Secondary|Thrombocyte Values||Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks)|"Number of participants analyzed=treated participants with data available for thrombocyte value. Here, n specifies number of participants with data available for specified category."||billion cells per liter||Standard Deviation|Mean
636307|NCT02556307|Secondary|HCV RNA Values||Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks)|"Number of participants analyzed=treated participants with data available for HCV RNA. Here, n specifies number of participants with data available for specified category."||IU/mL||Standard Deviation|Mean
636308|NCT02556307|Secondary|Percentage of Participants With Undetectable HCV RNA|Undetectable HCV RNA=a single last HCV RNA <20 IU/mL|Weeks 4, 12 and at end of treatment (up to 99.6 weeks)|All treated participants were included in the analysis.||percentage of participants|||Number
636309|NCT02556307|Primary|Percentage of Participants Achieving Sustained Virological Response (SVR) According to Genotype and Previous Treatment|SVR was defined as participants with undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) at 24 weeks after completion of treatment. Undetectable HCV RNA was defined as a single last HCV RNA less than (<) 20 international units per milliliter (IU/mL). SVR was evaluated based on HCV genotype (G1, G2, G3 and G4), participant's interleukin 28B genotype (CC, CT and TT), and previous treatment (treatment naive or previous treatment).|6 months after the last study drug administration (up to 123.6 weeks)|All treated participants were included in the analysis. Here, 'n' specifies the number of participants included in the analysis as per the specified category (genotype or previous treatment).||percentage of participants|||Number
636310|NCT02555722|Secondary|Ease of Insertion and Removal - Enfilcon A Lens (Control)|Ease of Insertion and removal was assessed. Scale 0-100 (0=excellent, no problems with lens insertion/removal; 100=unmanageable, lenses impossible to handle)|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3|||units on a scale|Eyes|Standard Deviation|Mean
636311|NCT02555722|Secondary|Ease of Insertion and Removal - Fanfilcon A Lens (Test)|Ease of Insertion and removal was assessed. Scale 0-100 (0=excellent, no problems with lens insertion/removal; 100=unmanageable, lenses impossible to handle)|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3|||units on a scale|Eyes|Standard Deviation|Mean
636312|NCT02555722|Secondary|Overall Vision Quality - Enfilcon A Lens (Control)|Overall vision quality and night vision quality is assessed at the specific time points. Scale 0-100 (0=excellent, cannot notice any visual loss; 100=unacceptable, lens cannot be worn)|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3|||units on a scale|Eyes|Standard Deviation|Mean
636313|NCT02555722|Secondary|Overall Vision Quality - Fanfilcon A Lens (Test)|Overall vision quality and night vision quality is assessed at the specific time points. Scale 0-100 (0=excellent, cannot notice any visual loss; 100=unacceptable, lens cannot be worn)|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3|||units on a scale|Eyes|Standard Deviation|Mean
636314|NCT02555722|Secondary|Comfort - Enfilcon A Lens (Control)|Enfilcon A lens (control) are assessed regarding comfort for the following: comfort upon insertion, comfort during the day, end of the day comfort, overall comfort, and comfort at visit. Scale 0-100 (0=excellent, cannot be felt; 100=causes pain, lens cannot be tolerated)|Baseline, 1 week, 2 weeks, 1 month, 2 months, 3 months follow-up|||units on a scale|Eyes|Standard Deviation|Mean
636315|NCT02555722|Secondary|Comfort - Fanfilcon A Lens (Test)|Fanfilcon A lens (test) are assessed regarding comfort for the following: comfort upon insertion, comfort during the day, end of the day comfort, overall comfort, and comfort at visit. Scale 0-100 (0=excellent, cannot be felt; 100=causes pain, lens cannot be tolerated)|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3|||units on a scale|Eyes|Standard Deviation|Mean
636316|NCT02555722|Primary|Average Wearing Time - Enfilcon A Lens (Control)|Average lens wearing time for enfilcon A lens (control) measured in hours.|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3|||hours||Standard Deviation|Mean
636317|NCT02555722|Primary|Average Wearing Time - Fanfilcon A Lens (Test)|Average lens wearing time for fanfilcon A lens (test) measured in hours.|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3|||hours||Standard Deviation|Mean
636318|NCT02555722|Primary|Visual Acuity - Enfilcon A Lens (Control)|Visual acuity is assessed for enfilcon A lens (control) using Snellen chart.|Week 1, Week 2, Month 1, Month 2, Month 3|||eyes|Eyes||Number
636319|NCT02555722|Primary|Visual Acuity - Fanfilcon A Lens (Test)|Visual acuity is assessed for fanfilcon A lens (test) using Snellen chart.|Week 1, Week 2, Month 1, Month 2, Month 3|||eyes|Eyes||Number
636320|NCT02555722|Primary|Palpebral Conjunctiva - Enfilcon A Lens (Control)|Palpebral conjunctiva is assessed for enfilcon A lens (control). Grading scale: absent/present|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3|||percentage of eyes|Eyes||Number
636321|NCT02555722|Primary|Palpebral Conjunctiva - Fanfilcon A Lens (Test)|Palpebral conjunctiva is assessed for fanfilcon A lens (test). Grading scale: Absent/present|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3|||percentage of eyes|Eyes||Number
636324|NCT02555722|Primary|Limbal Hyperemia - Enfilcon A Lens (Control)|Limbal hyperemia is assessed for enfilcon A lens (control). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3|||percentage of eyes|Eyes||Number
636325|NCT02555722|Primary|Limbal Hyperemia - Fanfilcon A Lens (Test)|Limbal hyperemia is assessed for fanfilcon A lens (test). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3|||percentage of eyes|Eyes||Number
636326|NCT02555722|Primary|Corneal Staining - Enfilcon A Lens (Control)|Corneal staining with fluorescein is assessed for enfilcon A lens (control). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe; Grading regions: S - Superior, T - Temporal, C - Central, N - Nasal, I - Inferior;|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3|||percentage of eyes|Eyes||Number
636327|NCT02555722|Primary|Corneal Staining - Fanfilcon A Lens (Test)|Corneal staining with fluorescein is assessed for fanfilcon A lens (test). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe; Grading regions: S - Superior, T - Temporal, C - Central, N - Nasal, I - Inferior;|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3|||percentage of eyes|Eyes||Number
636328|NCT02555722|Primary|Corneal Vascularization - Enfilcon A Lens (Control)|Corneal vascularization is assessed for enfilcon A lens (control). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3|||percentage of eyes|Eyes||Number
636329|NCT02555722|Primary|Corneal Vascularization - Fanfilcon A Lens (Test)|Corneal vascularization is assessed for fanfilcon A lens (test). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3|||percentage of eyes|Eyes||Number
636330|NCT02555722|Primary|Corneal Infiltrates - Enfilcon A Lens (Control)|Corneal infiltrates is assessed for enfilcon A lens (control). Grading scale: absent/present|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3|||percentage of eyes|Eyes||Number
636331|NCT02555722|Primary|Corneal Infiltrates - Fanfilcon A Lens (Test)|Corneal infiltrates is assessed for fanfilcon A lens (test). Grading scale: Absent/present|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3|||percentage of eyes|Eyes||Number
636332|NCT02555722|Primary|Stromal Edema - Enfilcon A Lens (Control)|Stromal edema is assessed for enfilcon A lens (control). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3|||percentage of eyes|Eyes||Number
636333|NCT02555722|Primary|Stromal Edema - Fanfilcon A Lens (Test)|Stromal edema is assessed for fanfilcon A lens (test). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3|||percentage of eyes|Eyes||Number
636334|NCT02555722|Primary|Epithelial Edema - Enfilcon A Lens (Control)|Epithelial edema is assessed for enfilcon A lens (control). Grading scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3|||percentage of eyes|Eyes||Number
636335|NCT02555722|Primary|Epithelial Edema - Fanfilcon A Lens (Test)|Epithelial edema is assessed for fanfilcon A lens (test). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3|||percentage of eyes|Eyes||Number
636336|NCT02555618|Secondary|Percentage of Participants With Abnormal Safety Laboratory Tests at Least Once Post Dose Reported as AEs|The percentage of participants with any abnormal standard safety laboratory values (Chemistry, Hematology and Urinalysis) collected throughout the study reported as AEs.|22 Days|Safety Analysis Set included all participants who received vaccination with study vaccine.||percentage of participants|||Number
636337|NCT02555618|Secondary|Percentage of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)|Adverse events are defined as unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product, regardless of relationship to the medicinal product. TEAE is defined as an adverse event with an onset that occurs after receiving study drug.|22 days|Safety Analysis Set included all participants who received vaccination with study vaccine.||percentage of participants|||Number
636338|NCT02555618|Secondary|Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs)|Participants recorded solicited injection site and systemic adverse events in a Subject Diary. Solicited Locals AEs were: Injection Site Pain, Injection Site Redness, Injection Site Swelling, Injection Site Induration and Injection Site Ecchymosis. Solicited Systemic AEs were: Pyrexia, Malaise, Chills, Fatigue, Headache, Sweaty, Myalgia, Arthralgia, Nausea and Vomiting.|22 Days|Safety Analysis Set included all participants who received vaccination with study vaccine.||percentage of participants|||Number
636339|NCT02555618|Secondary|Geometric Mean Fold Increase in SRH Antibody Titer (Vero-Derived Antigen)|Geometric mean fold increase in SRH antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination, as compared with Baseline.|Baseline and Day 22|FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.||fold increase||95% Confidence Interval|Geometric Mean
636340|NCT02555618|Secondary|Seroprotection Rate of SRH Antibody Titer (Vero-Derived Antigen)|Seroprotection rate, defined as the percentage of participants with SRH antibody titer ≥25 mm^2, was measured by SRH antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference.|Days 1 and 22|FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.||percentage of participants||95% Confidence Interval|Number
636341|NCT02555618|Secondary|GMT of SRH Antibody Titer (Vero-Derived Antigen)|GMT of SRH antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference.|Days 1 and 22|FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.||titer||95% Confidence Interval|Geometric Mean
636342|NCT02555618|Secondary|Seroconversion Rate of SRH Antibody Titer (Vero-Derived Antigen)|Seroconversion rate, defined as the percentage of participants with a Baseline SRH antibody titer of >4 mm^2 achieving a minimal 50% increase, or a Baseline SRH antibody titer of ≤4 mm^2 achieving a SRH antibody titer of ≥25 mm^2, was measured by SRH antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination.|Baseline and Day 22|FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.||percentage of participants||95% Confidence Interval|Number
636343|NCT02555618|Secondary|Geometric Mean Fold Increase in HI Antibody Titer (Vero-Derived Antigen)|Geometric mean fold increase in HI antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination, as compared with Baseline.|Baseline and Day 22|FAS included all participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.||fold increase||95% Confidence Interval|Geometric Mean
636344|NCT02555618|Secondary|Seroprotection Rate of HI Antibody Titer (Vero-Derived Antigen)|Seroprotection rate, defined as the percentage of participants with HI antibody titer ≥40, was measured by HI antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference.|Days 1 and 22|FAS included all participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.||percentage of participants||95% Confidence Interval|Number
636345|NCT02555618|Secondary|GMT of HI Antibody Titer (Vero-Derived Antigen)|GMT of HI antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference.|Days 1 and 22|FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.||titer||95% Confidence Interval|Geometric Mean
636346|NCT02555618|Secondary|Seroconversion Rate of HI Antibody Titer (Vero-Derived Antigen)|Seroconversion rate, defined as the percentage of participants with a Baseline HI antibody titer of ≥10 achieving a minimal 4-fold increase, or a Baseline HI antibody titer of <10 achieving a HI antibody titer of ≥40, was measured by HI antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination.|Baseline and Day 22|FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.||percentage of participants||95% Confidence Interval|Number
636347|NCT02555618|Secondary|Geometric Mean Fold Increase in SRH Antibody Titer (Egg-Derived Antigen)|Geometric mean fold increase in SRH antibody titer (egg-derived antigen) for each of the three strains, 21 days after vaccination, as compared with Baseline.|Baseline and Day 22|FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.||fold increase||95% Confidence Interval|Geometric Mean
636348|NCT02555618|Secondary|Seroprotection Rate of SRH Antibody Titer (Egg-Derived Antigen)|Seroprotection rate, defined as the percentage of participants with SRH antibody titer ≥25 mm^2, was measured by SRH antibody titer (egg-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference.|Days 1 and 22|FAS included all participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.||percentage of participants||95% Confidence Interval|Number
636349|NCT02555618|Secondary|GMT of SRH Antibody Titer (Egg-Derived Antigen)|GMT of SRH antibody titer (egg-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference.|Days 1 and 22|FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.||mm^2||95% Confidence Interval|Geometric Mean
636350|NCT02555618|Secondary|Seroconversion Rate of Single Radial Hemolysis (SRH) Antibody Titer (Egg-Derived Antigen)|Seroconversion rate, defined as the percentage of participants with a Baseline SRH antibody titer of >4 mm^2 achieving a minimal 50% increase, or a Baseline SRH antibody titer of ≤4 mm^2 achieving a SRH antibody titer of ≥25 mm^2, as measured by single radial hemolysis (SRH) antibody titer (egg-derived antigen) for each of the three strains, 21 days after vaccination.|Baseline and Day 22|FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.||percentage of participants||95% Confidence Interval|Number
636351|NCT02555618|Secondary|Geometric Mean Fold Increase in HI Antibody Titer (Egg-Derived Antigen)|Geometric mean fold increase in HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination, as compared with Baseline.|Baseline and Day 22|FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.||fold increase||95% Confidence Interval|Geometric Mean
636352|NCT02555618|Secondary|Seroprotection Rate of HI Antibody Titer (Egg-Derived Antigen)|Seroprotection rate, defined as the percentage of participants with HI antibody titer of ≥40, was measured by HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination. Day 1 data is reported for reference.|Days 1 and 22|FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.||percentage of participants||95% Confidence Interval|Number
636353|NCT02555618|Primary|Geometric Mean Titer (GMT) of HI Antibody Titer (Egg-Derived Antigen)|Geometric mean titer (GMT) of HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination. Day 1 data is reported for reference.|Days 1 and 22|FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.||titer||95% Confidence Interval|Geometric Mean
636354|NCT02555618|Primary|Seroconversion Rate of Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen)|"Seroconversion rate was measured by hemagglutination inhibition (HI) antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination.
Seroconversion rate was defined as the percentage of participants achieving a minimal 4-fold increase from the Baseline HI antibody titer in participants with a Baseline titer ≥10, or achieving an HI antibody titer of ≥40 in participants with a Baseline titer <10."|Baseline and Day 22|Full Analysis Set (FAS) included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.||percentage of participants||95% Confidence Interval|Number
636355|NCT02555228|Secondary|Adverse Events in Each Group Which May or May Not be Related to Simethicone Solution||Participants will be followed from ingestion of the premedication to the time of discharge from the endoscopy center, an estimated duration. of 3 hours|||number of events|||Number
636356|NCT02555228|Secondary|Volume of Additional Manual Flushes Required During Endoscopy in Mls|The volume of additional water (in mls) flushed during the gastroscopy in order to remove obscuring foam or bubbles.|This will be calculated during the diagnostic gastroscopy, an expected duration of 10 minutes.|||mls||Standard Deviation|Mean
636357|NCT02555228|Secondary|Mucosal Visibility Score Per Area as Determined by Mc Nally Score:|"Area E: esophagus
Area D: duodenum
Area A: antrum and angularis
Area B: body and fundus
Mc Nally score per area:
Score of 1: no bubbles Score of 2: minimal-occasional bubbles; must actively look for them Score of 3: moderate-obviously present Score of 4: severe-so many bubbles that vision is obscured"|This will be calculated during the diagnostic gastroscopy, an expected duration of 10 minutes.|||units on a scale||Standard Deviation|Mean
636358|NCT02555228|Primary|Total Cumulative Mucosal Visibility Score|"Total cumulative mucosal visibility score (TMVS) of all areas during the gastroscopy as determined by Mc Nally score:
Score of 1: no bubbles Score of 2: minimal-occasional bubbles; must actively look for them Score of 3: moderate-obviously present Score of 4: severe-so many bubbles that vision is obscured
Total areas covered:
(E) esophagus (D) duodenum (A) Antrum and angularis (B) body and fundus"|This will be calculated during the diagnostic gastroscopy, an expected duration of 10 minutes.|||units||Standard Deviation|Mean
636359|NCT02554981|Secondary|Change From Baseline in the Ocular Discomfort Scale Post Wilkins Test in the Worst Eye|Participants assessed ocular discomfort post Wilkins Rate of Reading Test using the Ora Calibra™ 5-point scale where 0=no discomfort to 4=constant discomfort. A positive number change from Baseline indicates a worsening and a negative number change from Baseline indicates an improvement.|Baseline, Month 6|"Participant from the ITT population, all enrolled participants who received at least one dose of study drug, with data available for analysis. n in the category is the number of participants with data available at the given time-point."||score on a scale||Standard Deviation|Mean
636360|NCT02554981|Secondary|Change From Baseline in Reading on the OSDI©|The OSDI© consists of 12 questions measuring the presence of ocular symptoms. The Reading question was assessed using a 5-point scale (0=none of the time to 4=all of the time). Higher OSDI© scores are associated with greater severity. A negative number change from Baseline indicates improvement and a positive number change from Baseline indicates worsening.|Baseline, Month 6|"ITT population included all enrolled participants who received at least one dose of study drug. n in the category is the number of participants with data available at the given time-point."||score on a scale||Standard Deviation|Mean
636361|NCT02554981|Secondary|Change From Baseline in Poor Vision on the OSDI©|The OSDI© consists of 12 questions measuring the presence of ocular symptoms. The Poor Vision question was assessed using a 5-point scale (0=none of the time to 4=all of the time). Higher OSDI© scores are associated with greater severity. A negative number change from Baseline indicates improvement and a positive number change from Baseline indicates worsening.|Baseline, Month 6|"ITT population included all enrolled participants who received at least one dose of study drug. n in the category is the number of participants with data available at the given time-point."||score on a scale||Standard Deviation|Mean
636362|NCT02554981|Secondary|Change From Baseline in Blurred Vision on the OSDI©|The OSDI© consists of 12 questions measuring the presence of ocular symptoms. The Blurred Vision question was assessed using a 5-point scale (0=none of the time to 4=all of the time). Higher OSDI© scores are associated with greater severity. A negative number change from Baseline indicates improvement and a positive number change from Baseline indicates worsening.|Baseline, Month 6|"ITT population included all enrolled participants who received at least one dose of study drug. n in the category is the number of participants with data available at the given time-point."||score on a scale||Standard Deviation|Mean
636363|NCT02554981|Secondary|Change From Baseline in Watching Television (TV) on the OSDI©|The OSDI© consists of 12 questions measuring the presence of ocular symptoms. The Watching TV question was assessed using a 5-point scale (0=none of the time to 4=all of the time). Higher OSDI© scores are associated with greater severity. A negative number change from Baseline indicates improvement and a positive number change from Baseline indicates worsening.|Baseline, Month 6|"Participants from the ITT population, all enrolled participants who received at least one dose of study drug with data available for analysis. n in the category is the number of participants with data available at the given time-point."||score on a scale||Standard Deviation|Mean
636364|NCT02554981|Secondary|Change From Baseline in Working With a Computer or Bank Machine on the OSDI©|The OSDI© consists of 12 questions measuring the presence of ocular symptoms. The Working with a Computer or Bank Machine question was assessed using a 5-point scale (0=none of the time to 4=all of the time). Higher OSDI© scores are associated with greater severity. A negative number change from Baseline indicates improvement and a positive number change from Baseline indicates worsening.|Baseline, Month 6|"Participants from the ITT population, all enrolled participants who received at least one dose of study drug with data available for analysis. n in the category is the number of participants with data available at the given time-point."||score on a scale||Standard Deviation|Mean
636365|NCT02554981|Secondary|Change From Baseline in Driving at Night on the OSDI©|The OSDI© consists of 12 questions measuring the presence of ocular symptoms. The Driving at Night question was assessed using a 5-point scale (0=none of the time to 4=all of the time). Higher OSDI© scores are associated with greater severity. A negative number change from Baseline indicates improvement and a positive number change from Baseline indicates worsening.|Baseline, Month 6|"Participants from the ITT population, all enrolled participants who received at least one dose of study drug with data available for analysis. n in the category is the number of participants with data available at the given time-point."||score on a scale||Standard Deviation|Mean
636366|NCT02554981|Secondary|Change From Baseline in OSDI© Total Score|The OSDI© questionnaire consists of 12 questions measuring the presence of ocular symptoms. Each of the 12 questions was assessed using a 5-point scale (where 0=none of the time and 4=all of the time). The score is converted to a 0 to 100 point score where 0 is no symptoms and 100 is most symptoms. A negative change from Baseline indicates improvement.|Baseline, Month 6|"ITT population included all enrolled participants who received at least one dose of study drug. n in the category is the number of participants with data available at the given time-point."||score on a scale||Standard Deviation|Mean
657718|NCT01916681|Secondary|Mode of Delivery|Cesarean Delivery|Start of induction to delivery|||participants|||Number
636367|NCT02554981|Secondary|Change From Baseline in Interblink Interval (IBI) in the Worst Eye|A device was used to assess IBI. The IBI measures the time in seconds between blinks in the worse eye. A positive number change from baseline indicates a worsening (more frequent blinks) and a negative number change from baseline (less frequent blinks) indicates an improvement.|Baseline, Month 6|"ITT population included all enrolled participants who received at least 1 dose of study drug. n in the category is the number of participants with data available at the given time-point."||seconds||Standard Deviation|Mean
636368|NCT02554981|Secondary|Change From Baseline in Ocular Protection Index (OPI) 2.0 in the Worse Eye|A device was used to assess OPI 2.0. This technology measures blink and tear film break-up area. These values demonstrate the average area of tear deficiency/corneal exposure. The worse eye is defined as the worse eye at Baseline. A negative value indicates an improvement in corneal protection.|Baseline, Month 6|"Participants from the ITT population, all enrolled participants who received at least one dose of study drug with data available for analysis. n in the category is the number of participants with data available at the given time-point."||percent of area||Standard Deviation|Mean
636369|NCT02554981|Secondary|Change From Baseline in Tear Film Break Up Time (TFBUT) in the Worse Eye|TFBUT is defined as the time required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. The worse eye is defined as the Worse Eye at Baseline. A positive number change from Baseline indicates improvement and a negative number change from Baseline indicates a worsening.|Baseline, Month 6|"ITT population included all enrolled participants who received at least one dose of study drug. n in the category is the number of participants with data available at the given time-point."||seconds||Standard Deviation|Mean
636370|NCT02554981|Primary|Change From Baseline in Reading Rate|Reading speed was assessed as the number of words read correctly calculated as words/minute. A positive change from Baseline indicates an improvement (more words read correctly/minute) and a negative change from Baseline indicates a worsening (less words read correctly/minute).|Baseline, Month 6|"ITT population was defined as all enrolled participants who received at least one dose of study drug. n in the category is the number of participants with data available at the given time-point."||correct words/minute||Standard Deviation|Mean
636371|NCT02554981|Primary|Change From Baseline in Time to Read Passage|The time to read passage (selected portion of text ) in seconds was assessed. A negative change from Baseline indicates an improvement (less time to read the passage).|Baseline, Month 6|"ITT population was defined as all enrolled participants who received at least one dose of study drug. n in the category is the number of participants with data available at the given time-point."||seconds||Standard Deviation|Mean
636372|NCT02554981|Primary|Change From Baseline in Words Read Incorrectly|The numbers of words read incorrectly are counted. A positive change from Baseline indicates a worsening (more words read incorrectly) and a negative change from Baseline indicates an improvement.|Baseline, Month 6|"ITT population was defined as all enrolled participants who received at least one dose of study drug. n in the category is the number of participants with data available at the given time-point."||incorrect words||Standard Deviation|Mean
636373|NCT02554981|Primary|Change From Baseline in Font Size|The minimum font (letter) size read correctly was assessed. Smaller font size (less points) indicates better ability. A negative change from Baseline indicates an improvement and a positive change from Baseline indicates a worsening.|Baseline, Month 6|"ITT population was defined as all enrolled participants who received at least one dose of study drug. n in the category is the number of participants with data available at the given time-point."||points||Standard Deviation|Mean
636374|NCT02554981|Primary|Change From Baseline in the Central Region Staining Score With Lissamine Green in the Worse Eye|Staining with lissamine green in the central region of the eye was measured in the worse eye using the Ora Calibra™ (Scale 1.0) 5-point scale where 0= none (best), no staining to 4=severe staining (worst). The worse eye is defined as the worst eye at Baseline. A negative change from Baseline represents a decrease in staining (improvement).|Baseline, Month 6|"ITT population included all enrolled participants who received at least one dose of the study drug. n in the category is the number of participants with data available at the given time-point."||score on a scale||Standard Deviation|Mean
636375|NCT02554981|Primary|Change From Baseline in the Total Conjunctival Staining Score With Lissamine Green in the Worse Eye|Total conjunctival staining with lissamine green was measured in the worse eye using the Ora Calibra™ (Scale 1.0) 5-point scale where 0= none (best), no staining to 4=severe staining (worst). The sum of the total includes 2 regions of the conjunctiva, resulting in a maximum possible score of 8 (severe staining score of 4 in both regions). The worse eye is defined as the worst eye at Baseline. A negative change from Baseline represents a decrease in staining (improvement).|Baseline, Month 6|"ITT population included all enrolled participants who received at least one dose of the study drug. n in the category is the number of participants with data available at the given time-point."||score on a scale||Standard Deviation|Mean
636376|NCT02554981|Primary|Change From Baseline in the Total Corneal Staining Score With Lissamine Green in the Worse Eye|Total corneal staining with lissamine green was measured in the worse eye using the Ora Calibra™ (Scale 1.0) 5-point scale where 0= none (best), no staining to 4=severe staining (worst). The sum of the total includes 3 regions of the cornea, resulting in a maximum possible score of 12 (severe staining score of 4 in all three regions). The worse eye is defined as the worst eye at Baseline. A negative change from Baseline represents a decrease in staining (improvement).|Baseline, Month 6|"ITT population included all enrolled participants who received at least one dose of the study drug. n in the category is the number of participants with data available at the given time-point."||score on a scale||Standard Deviation|Mean
636377|NCT02554981|Primary|Change From Baseline in the Central Region Staining Score With Fluorescein in the Worse Eye|Staining with fluorescein in the central region of the eye was measured in the worse eye using the Ora Calibra™ (Scale 1.0) 5-point scale where 0= none (best), no staining to 4=severe staining (worst). The worse eye is defined as the worst eye at Baseline. A negative change from Baseline represents a decrease in staining (improvement).|Baseline, Month 6|"ITT population included all enrolled participants who received at least one dose of the study drug. n in the category is the number of participants with data available at the given time-point."||score on a scale||Standard Deviation|Mean
636403|NCT02553512|Primary|Frequency of Medication-taking (% Taking Adherence)|Percent timing adherence is determined by the number of ingestion sensors detected by the wearable monitor, divided by the total number of ingestion sensors prescribed, for the 2 week-time frame.|2 weeks|||percentage of taking adherence||Full Range|Median
636378|NCT02554981|Primary|Change From Baseline in the Total Conjunctival Staining Score With Fluorescein in the Worse Eye|Total conjunctival staining with fluorescein was measured in the worse eye using the Ora Calibra™ (Scale 1.0) 5-point scale where 0= none (best), no staining to 4=severe staining (worst). The sum of the total includes 2 regions of the conjunctiva, resulting in a maximum possible score of 8 (severe staining score of 4 in both regions). The worse eye is defined as the worst eye at Baseline. A negative change from Baseline represents a decrease in staining (improvement).|Baseline, Month 6|"ITT population included all enrolled participants who received at least one dose of the study drug. n in the category is the number of participants with data available at the given time-point."||score on a scale||Standard Deviation|Mean
636379|NCT02554981|Primary|Change From Baseline in the Total Corneal Staining Score With Fluorescein in the Worse Eye|Total corneal staining with fluorescein was measured in the worse eye using the Ora Calibra™ (Scale 1.0) 5-point scale where 0= none (best), no staining to 4=severe staining (worst). The sum of the total includes 3 regions of the cornea, resulting in a maximum possible score of 12 (severe staining score of 4 in all three regions). The worse eye is defined as the worst eye at Baseline. A negative change from Baseline represents a decrease in staining (improvement).|Baseline, Month 6|"ITT population included all enrolled participants who received at least one dose of the study drug. n in the category is the number of participants with data available at the given time-point."||score on a scale||Standard Deviation|Mean
636380|NCT02554877|Secondary|Changes From Baseline in Body Weight at Weeks 2, 4, 8, and 12.|The body weight change from baseline (defined as the mean of Day 14 and Day 1 pre-dose) at Weeks 2,4,8 and 12. n represented the available number of participants for analysis at post-baseline days.|Baseline, Weeks 2, 4, 8 and 12|All participants randomized and who received at least 1 dose of randomized treatment, participants were assigned to the randomized treatment regardless of what treatment was received. n represented the available number of participants for analysis at post-baseline days.||kg||Standard Deviation|Mean
636381|NCT02554877|Secondary|Percent Changes From Baseline for Non‑High Density Lipoprotein (HDL) Cholesterol at Weeks 2, 4, 8 and 12|Non-HDL-C percent change from baseline (defined as the mean of Day 14 and Day 1 pre-dose) on Weeks 2,4,8 and 12. n represented the available number of participants for analysis at post-baseline days.|Baseline, Weeks 2, 4, 8 and 12|All participants randomized and who received at least 1 dose of randomized treatment, participants were assigned to the randomized treatment regardless of what treatment was received. n represented the available number of participants for analysis at post-baseline days.||% (percent change)||Standard Deviation|Mean
636382|NCT02554877|Secondary|Percent Changes From Baseline for High Density Lipoprotein‑Cholesterol (HDL‑C) at Weeks 2, 4, 8 and 12|High density lipoprotein-cholesterol (HDL-C) percent change from baseline (defined as the mean of Day 14 and Day 1 pre-dose) at Weeks 2,4,8 and 12. n represented the available number of participants for analysis at post-baseline days.|Baseline, Weeks 2, 4, 8 and 12|All participants randomized and who received at least 1 dose of randomized treatment, participants were assigned to the randomized treatment regardless of what treatment was received. n represented the available number of participants for analysis at post-baseline days.||% (percent change)||Standard Deviation|Mean
636383|NCT02554877|Secondary|Percent Changes From Baseline for Total Cholesterol at Weeks 2, 4, 8 and 12|Total cholesterol percent change from baseline (defined as the mean of Day 14 and Day 1 pre-dose) on Weeks 2,4,8 and 12. n represented the available number of participants for analysis at post-baseline days.|Baseline, Weeks 2, 4, 8 and 12|All participants randomized and who received at least 1 dose of randomized treatment, participants were assigned to the randomized treatment regardless of what treatment was received. n represented the available number of participants for analysis at post-baseline days.||% (percent change)||Standard Deviation|Mean
636384|NCT02554877|Secondary|Percent Changes From Baseline for Triglycerides at Weeks 2, 4, 8 and 12|Triglycerides percent change from baseline (defined as the mean of Day 14 and Day 1 pre-dose) at Weeks 2,4,8 and 12. n represented the available number of participants for analysis at post-baseline days. Triglycerides MMRM was not appropriate as the data were very skewed and not normally distributed, therefore per SAP non-parametric analysis were reported, presenting medians and CIs for medians, instead. If the data had many outliers even after the log transformation the following non parametric analysis was presented instead of the MMRM. An outlier was defined as any data point falling outside of 3.5 x standard deviations the median.|Baseline, Weeks 2, 4, 8 and 12|All participants randomized and who received at least 1 dose of randomized treatment, participants were assigned to the randomized treatment regardless of what treatment was received. n represented the available number of participants for analysis at post-baseline days.||% (percent change)||Full Range|Median
636385|NCT02554877|Secondary|Percent Changes From Baseline for Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Weeks 2, 4, 8 and 12|Fasting low density lipoprotein-cholesterol (LDL-C) percent change from baseline (defined as the mean of Day 14 and Day 1 pre-dose) at Weeks 2,4,8 and 12. n represented the available number of participants for analysis at post-baseline days.|Baseline, Weeks 2, 4, 8 and 12|All participants randomized and who received at least 1 dose of randomized treatment, participants were assigned to the randomized treatment regardless of what treatment was received. n represented the available number of participants for analysis at post-baseline days.||% (percent change)||Standard Deviation|Mean
636386|NCT02554877|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Hypoglycemic Adverse Events (HAEs).|An adverse event (AE) was any untoward medical occurrence in a participant administered a study drug; the event need not necessarily have a causal relationship with the treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reasons: death; life threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. An HAE was identified by characteristic symptoms or blood glucose levels. Any events occurring following start of treatment (defined as blinded therapy, including single blind placebo administration on Day 14) or increasing in severity were counted as treatment emergent AE.|Baseline up to Day 119|The safety analysis set was used, which defined as all participants who received at least 1 dose of study drug.||participants|||Number
636402|NCT02553512|Primary|Pattern of Medication-taking (% Scheduling Adherence)|Percent scheduling adherence is determined by the number of ingestion sensors detected within a ± 2-hour time window around the prescribed dosing period, divided by the number of ingestion sensors detected by the wearable sensor during that dosing period, over the 2-week time frame.|2 weeks|||percentage of scheduling adherence||Full Range|Median
636387|NCT02554877|Secondary|Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria|Vital signs included seated supine systolic and diastolic blood pressure (BP) and pulse rate. Vital signs criteria of potential clinical concern were 1), BP: systolic (SBP) greater than or equal to (>=) 30 millimeters of mercury (mm Hg) change from baseline, systolic less than (<) 90 mm Hg; diastolic BP (DBP) >=20 mm Hg change from baseline, diastolic <50 mm Hg; 2), pulse rate <40 or greater than (>) 120 beats per minute (bpm).|Baseline up to Day 98|The safety analysis set was used, which defined as all participants who received at least 1 dose of study drug.||participants|||Number
636388|NCT02554877|Secondary|Number of Participants With Change From Baseline and Absolute Values in 12-lead Electrocardiograms (ECGs) Meeting Categorical Summarization Criteria|ECG criteria of potential clinical concern were 1), time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization (QRS interval): >=140 milliseconds (msec); >=50% increase from baseline; 2), the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization (PR interval): >=300 msec; >=25 percent (%) increase when baseline >200 msec; or increase >=50% when baseline less than or equal to (<=)200 msec; 3), time from ECG Q wave to the end of the T wave corresponding to electrical systole corrected for heart rate using Fridericia’s formula (QTcF interval): absolute value >=450 - <480 msec, >=480-<500 msec, >=500 msec; increase from baseline >=30 - <60, >=60 msec.|Baseline up to Day 98|The safety analysis set was used, which defined as all participants who received at least 1 dose of study drug.||participants|||Number
636389|NCT02554877|Secondary|Number of Participants With Laboratory Test Abnormalities|The total number of participants with laboratory test abnormalities (without regard to baseline abnormality) was assessed. Clinical laboratory tests included hematology, chemistry, urinalysis, and some other tests.|Baseline up to 98 days|The safety analysis set was used, which defined as all participants who received at least 1 dose of study drug.||participants|||Number
636390|NCT02554877|Secondary|Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c) <7% as Well as <6.5% at Week 12.|HbA1c was a form of hemoglobin which was measured primarily to identify the average plasma glucose concentration over prolonged periods of time.|Week 12|All participants randomized and who received at least 1 dose of randomized treatment, participants were assigned to the randomized treatment regardless of what treatment was received.||% (percentage of participants)||95% Confidence Interval|Number
636391|NCT02554877|Secondary|Change From Baseline in Fasting Plasma Glucose at Weeks 2, 4, 8, and 12|Fasting plasma glucose response changed from baseline at Weeks 2,4,8 and 12. Baseline was defined as the average of the measurements obtained during Day 14 visit window and Day 1 pre-dose measurement. n represented the available number of participants for analysis at post-baseline days.|Baseline, Weeks 2,4,8 and 12|All participants randomized and who had received at least 1 dose of randomized treatment. n represented the available number of participants for analysis at post-baseline days.||mg/dL||Standard Deviation|Mean
636392|NCT02554877|Secondary|Change From Baseline in HbA1c (%) at Weeks 2, 4, and 8|HbA1c was a form of hemoglobin which was measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Baseline was defined as the last pre-dose measurement prior to first double blind dosing for the study. n represented the available number of participants for analysis at post-baseline days.|Baseline, Weeks 2, 4, 8|All participants randomized and who received at least 1 dose of randomized treatment, participants were assigned to the randomized treatment regardless of what treatment was received.n represented the available number of participants for analysis at post-baseline days.||percentage of HbA1c||Standard Deviation|Mean
636393|NCT02554877|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) (%) at Week 12 as Compared to Placebo|HbA1c was a form of hemoglobin which was measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Baseline was defined as the last pre-dose measurement prior to first double blind dosing for the study.|Baseline, Week 12|All participants randomized and who received at least 1 dose of randomized treatment, participants were assigned to the randomized treatment regardless of what treatment was received.||percentage of HbA1c||Standard Deviation|Mean
636394|NCT02553629|Secondary|Mean Arterial Blood Pressure|"Mean arterial pressure (MAP in mmHg) will be monitored at 10 minute intervals for 2 hours in the post anesthesia care unit.
The data will be averaged per subject and the mean of the mean values are reported."|2 hours postoperative|||millimeters of mercury||Standard Deviation|Mean
636395|NCT02553629|Secondary|Respiration|"Respiration will be measured by counting the respiratory rate at 10 min interval for 2 hours in the post anesthesia care unit. The breaths per min (unit 1/min) will be logged.
The data were averaged per subject and the mean of the mean data are reported."|2 hours postoperative|||breaths per minute||Standard Deviation|Mean
636396|NCT02553629|Secondary|Pain|pain will be scored using numeric rating scale (0-10, with 0 = no pain and 10 = most pain imaginable), at 10 minute intervals at the post anesthesia care unit, but only the mean value will be used in the analysis and reported.|postoperative, for up to 2 hours|||units on a scale||Standard Deviation|Mean
636397|NCT02553629|Secondary|Extubation|The investigators will assess the time from the injection of the reversal agent until the time to removal of the endotracheal tune (extubation).|intraoperative|||minutes||Inter-Quartile Range|Mean
636398|NCT02553629|Primary|Surgical Rating|"During a procedure, the surgical condition will be scored by one surgeon using a 5-point surgical rating. This will be done at 10 min intervals from the start of surgery until the end of surgery scale. The rating scale is a 5-point ordinal scale ranging from 1 = poor condition to 5 = optimal surgical conditions. The mean difference in ratings between procedures under deep neuromuscular block and those during moderate neuromuscular block will be evaluated.
The rating scale will be averaged for each subject and the mean values will be reported."|intraoperative|||units on a scale||Standard Deviation|Mean
636399|NCT02553512|Secondary|Blood Pressure Management After Use of Digital Health Offering|Summary of provider actions following review of final report with patient (dose or medication change, adherence counseling, referral to a hypertension specialist)|4 weeks|||Participants|||Count of Participants
636400|NCT02553512|Secondary|Change in Systolic and Diastolic Blood Pressure After Use of Digital Health Offering|Decrease in systolic and diastolic blood pressure (measured in mm Hg) after 2 weeks when compared to baseline|2 weeks|||mm Hg||95% Confidence Interval|Mean
636401|NCT02553512|Secondary|Proportion of Patients Capable of Achieving Blood Pressure Control on Existing Treatment|Percentage of participants|2 weeks|||percentage of participants|||Number
636404|NCT02553421|Primary|Notification Rate of ivWatch Device|The notification rate is defined as the number of ivWatch device infiltration notifications issued in a certain amount of time, typically reported in units of notifications per day. The notification rate is the number of notifications per day, excluding cases with clinician confirmed infiltrations. This metric is measured using the subjects in the alarming group since the number of notifications could potentially depend on how quickly nurses reset the device.|Participants will be followed for the duration of intravenous therapy, an expected duration of up to 1 week|The number of participated in the Alarming group that did not have an infiltration diagnosed by a clinician.||Notifications per day||95% Confidence Interval|Number
636405|NCT02553421|Primary|Infiltration Sensitivity|The infiltration sensitivity is defined as the percentage of the clinician-confirmed infiltrations that are detected by the ivWatch device before the clinician’s diagnosis. This metric is measured and reported separately for non-alarming and alarming groups, since an infiltration notification by the ivWatch device could bias the clinician’s diagnosis.|Participants will be followed for the duration of intravenous therapy, an expected duration of up to 1 week|||percentage of infiltrations detected||95% Confidence Interval|Number
636406|NCT02553421|Primary|Time Infiltration Detected by Nurse|The difference in time to detection between the clinician and the ivWatch device is measured from the non-alarming group. This measurement reveals how much earlier the infiltration could have been detected by the ivWatch device compared to the clinician assessments. This metric is measured using the patients in the non-alarming group since an infiltration notification by the ivWatch device could bias the clinician’s diagnosis.|Participants will be followed for the duration of intravenous therapy, an expected duration of up to 1 week|||hours||95% Confidence Interval|Mean
636407|NCT02552810|Secondary|Percentage of Patients With Bleeding on Probing|Presence of bleeding within 10 seconds after probing. Measured as Yes or Not.|At 5 years.|||percentage of participants|||Number
636408|NCT02552810|Secondary|Percentage of Patients With Plaque Index|Modified Plaque Index (mPI) was evaluated as the amount of plaque at the cervical part of the implant-supported crown, scored by running a probe along the implant-supported crown surface. Measured as Yes or Not.|At 5 years.|||percentage of participants|||Number
636409|NCT02552810|Secondary|Esthetic Parameters Measured as the Changes in Mesial and Distal Papilla Height (PH) and Buccal Peri-implant Mucosa Changes at the Zenith (REC), Expressed in mm.|"A customized millimeter tubular support (stent) was placed temporarily around each dental implant. For each site, mesial and distal soft tissue dimensions (papilla height, PH), and buccal peri-implant mucosa dimension at the zenith (REC) were measured, and reported in millimeters. Two measurements were recorded. The first at definitive crown delivery (baseline), and the second at the 5 years follow-up examination. Changes in PH and REC were reported in millimeters as the difference between values recorded at the 5-year follow-up and the baseline.
The full procedure was published in:
Canullo L, Iurlaro G, Iannello G. Double-blind randomized controlled trial study on post-extraction immediately restored implants using the switching platform concept: soft tissue response. Preliminary report. Clinical Oral Implants Research [Internet]. 2009 Apr;20(4):414–20."|At 5 years.|||mm||Standard Deviation|Mean
636410|NCT02552810|Secondary|Peri-implant Marginal Bone Level Changes (Express in mm).|At the time of loading with the provisional crown (T0), periapical standardized digital or analogical radiographs were taken in order to control the perfect adaptation of the abutment on the implant and control peri-implant bone level. The customized film holder was made using an hard silicone on the bite of film holders (Rinn XCP; Dentsply Rinn, Elgin, IL, USA) and the parallel technique was used. Radiographs were also taken at 12 (T1), 24 (T2), 48 (T4), and 60 months (T5) after the final restoration delivery, to evaluate marginal bone level changes.|At 5 years.|||mm||Standard Deviation|Mean
636411|NCT02552810|Secondary|Any Biological or Technical Complications.|Complications: any biological (pain, swelling, suppuration, etc) and/or mechanical complications (fracture of the framework and/or the veneering material, screw loosening, etc) were considered.|During all the follow-up (5 years)|||participants|||Number
636412|NCT02552810|Primary|Success Rate of the Implants and Prostheses (Participants).|"An implant was considered a failure if it presented any mobility, assessed by tapping or rocking the implant head with the metallic handles of two instruments, and/or any signs of radiolucency, progressive marginal bone loss or infection, and any mechanical complications (e.g. implant fracture) rendering the implant unusable, though still mechanically stable in the bone. This was evaluated on an intraoral radiograph taken with a paralleling technique strictly perpendicular to the implant-bone interface. The implant stability was assessed at initial loading and following 3 years of application, with the prostheses removed.
A prosthesis was considered a failure if it needed to be replaced by an alternative prosthesis."|During all the follow-up (5 years)|||percentage of participants|||Number
636413|NCT02552303|Secondary|Number of Subjects Who Dropped Out|"Drop-out rates will be calculated by the number of protocol weeks the subject completed before withdrawing from the study. Drop out rates for subjects taking active v. placebo study medication were compared.
Withdrawal indicates subjects who were either lost-to-follow-up (LTFU), chose to withdraw (self-withdrawn), were withdrawn by the study's PI (withdrawn by the investigator)."|up to 8 weeks of active study|||Participants|||Count of Participants
636414|NCT02552303|Primary|The Change in Sleep Continuity From Baseline to Follow-up, as Measured by the Insomnia Severity Index (ISI).|"This outcome measure is based on changes in sleep continuity, as assessed by the Insomnia Severity Index (ISI), which is administered once at baseline and once at follow-up. The ISI (Morin, 1993) was used to assess perceived sleep difficulties or current insomnia symptom severity (i.e., past two weeks). The ISI is a 7-item, self-report instrument with good reliability and validity, and positively correlated with clinician-rated insomnia diagnoses (Bastien, Vallières, & Morin, 2001). Total scores on the full 7-item scale range from 0 – 28 with higher values representing greater sleep continuity disturbance or insomnia severity.
The four different treatment groups will be compared for differences."|ISI is measured once at baseline and once at follow-up (8-10 weeks apart)|||units on a scale (ISI)||Standard Deviation|Mean
636415|NCT02551887|Secondary|Second Dose HPV Vaccine Uptake|The rate of second dose of HPV vaccine uptake, is recorded as the number of patients who receive the second dose of HPV vaccine.|Nine Months|Number in the control condition who were eligible for 2 doses of vaccine.||Participants|||Number
636416|NCT02551887|Primary|First Dose HPV Vaccine Uptake|The outcome of primary interest, HPV vaccine uptake, is recorded as the number of patients who receive the first dose of HPV vaccine.|Nine Months|Number of patients that received the first dose of HPV vaccine.||Participants|||Number
636419|NCT02550288|Primary|Percentage of Participants Who Have Elevations in CK ≥10xULN and Drug-Related Muscle Symptoms|Participants had CK levels assessed throughout the 12 week treatment period. Participants who had any CK level that was ≥10 x ULN and had associated muscle symptoms present within +/- 7 days that were reported as at least possibly-related to study drug were recorded. The CK ULNs for males and females were 287 IU/L and 163 IU/L, respectively.|up to 12 weeks|All randomized participants who received at least 1 dose of actual study treatment.||Percentage of Participants|||Number
636420|NCT02550288|Primary|Percentage of Participants Who Have Elevations in CK ≥10xULN With Muscle Symptoms|Participants had CK levels assessed throughout the 12 week treatment period. Participants who had any CK level that was ≥10 x ULN and had associated muscle symptoms present within +/- 7 days were recorded. The CK ULNs for males and females were 287 IU/L and 163 IU/L, respectively.|up to 12 weeks|All randomized participants who received at least 1 dose of actual study treatment.||Percentage of Participants|||Number
636421|NCT02550288|Primary|Percentage of Participants Who Have Elevations in Creatine Kinase (CK) ≥10xULN|Participants had creatine phosphokinase (CK) levels assessed throughout the 12 week treatment period. Participants who had any CK level that was ≥10 x ULN were recorded. The CK ULNs for males and females were 287 IU/L and 163 IU/L, respectively.|up to 12 weeks|All randomized participants who received at least 1 dose of actual study treatment.||Percentage of Participants|||Number
636422|NCT02550288|Primary|Percentage of Participants With Potential Hy's Law Condition|Percentage of Participants with Potential Hy's Law Condition (defined as serum ALT or serum AST elevations >3xULN, with serum alkaline phosphatase <2xULN and total bilirubin (TBL) ≥2xULN) was summarized. The ALT and AST ULNs were 40 U/L. The ULN for alkaline phosphatase was 359 IU/L and the ULN for total bilirubin was 1.2 mg/dL.|up to 12 weeks|All randomized participants who received at least 1 dose of actual study treatment.||Percentage of Participants|||Number
636423|NCT02550288|Primary|Percentage of Participants Who Have Consecutive Elevations in ALT and/or AST ≥10 Times ULN|Participants had ALT and AST levels assessed throughout the 12 week treatment period. Participants who had 2 consecutive assessments of ALT and/or AST that were 10x ULN or greater were recorded. The ALT and AST ULNs were 40 U/L.|up to 12 weeks|All randomized participants who received at least 1 dose of actual study treatment.||Percentage of Participants|||Number
636424|NCT02550288|Primary|Percentage of Participants Who Experience Consecutive Elevations in AST ≥10 Times ULN|Participants had AST levels assessed throughout the 12 week treatment period. Participants who had 2 consecutive assessments of AST that were 10x ULN or greater were recorded. The AST ULN was 40 U/L.|up to 12 weeks|All randomized participants who received at least 1 dose of actual study treatment.||Percentage of Participants|||Number
636425|NCT02550288|Primary|Percentage of Participants Who Experience Consecutive Elevations in ALT ≥10 Times ULN|Participants had ALT levels assessed throughout the 12 week treatment period. Participants who had an assessment of ALT that was 10x ULN or greater were recorded. The ALT ULN was 40 U/L.|up to 12 weeks|All randomized participants who received at least 1 dose of actual study treatment.||Percentage of Participants|||Number
636426|NCT02550288|Primary|Percentage of Participants Who Have Consecutive Elevations in ALT and/or AST ≥5 Times ULN|Participants had ALT and AST levels assessed throughout the 12 week treatment period. Participants who had 2 consecutive assessments of ALT and/or AST that were 5 x ULN or greater were recorded. The ALT and AST ULNs were 40 U/L.|up to 12 weeks|All randomized participants who received at least 1 dose of actual study treatment.||Percentage of Participants|||Number
636427|NCT02550288|Primary|Percentage of Participants Who Experience Consecutive Elevations in AST ≥5 Times ULN|Participants had AST levels assessed throughout the 12 week treatment period. Participants who had an assessment of AST that was 5x ULN or greater were recorded. AST ULN was 40 U/L.|up to 12 weeks|All randomized participants who received at least 1 dose of actual study treatment.||Percentage of Participants|||Number
636428|NCT02550288|Primary|Percentage of Participants Who Experience Consecutive Elevations in ALT ≥5 Times ULN|Participants had ALT levels assessed throughout the 12 week treatment period. Participants who had an assessment of ALT that was 5x ULN or greater were recorded. The ALT ULN was 40 U/L.|up to 12 weeks|All randomized participants who received at least 1 dose of actual study treatment.||Percentage of Participants|||Number
636429|NCT02550288|Primary|Percentage of Participants Who Experience Consecutive Elevations in ALT and/or AST ≥3 Times ULN|Participants had ALT and AST levels assessed throughout the 12 week treatment period. Participants who had 2 consecutive assessments of ALT and/or AST that were 3 x ULN or greater were recorded. The ALT and AST ULNs were 40 U/L.|up to 12 weeks|All randomized participants who received at least 1 dose of actual study treatment.||Percentage of Participants|||Number
636430|NCT02550288|Primary|Percentage of Participants Who Experience Consecutive Elevations in Aspartate Aminotransferase (AST) ≥3 Times ULN|Participants had AST levels assessed throughout the 12 week treatment period. Participants who had 2 consecutive assessments of AST that were 3 x ULN or greater were recorded. The AST ULN was 40 U/L.|up to 12 weeks|All randomized participants who received at least 1 dose of actual study treatment.||Percentage of Participants|||Number
637766|NCT02472522|Other Pre-specified|Duration of Sensory Loss at T10 Level|The duration of sensory loss (from the subarachnoid block) at T10 level was assessed by pin-prick test by a sterile needle in minutes.|24 hours|||minutes||Standard Deviation|Mean
636431|NCT02550288|Primary|Percentage of Participants Who Experience Consecutive Elevations in Alanine Aminotransferase (ALT) ≥3 Times Upper Limit of Normal (ULN)|Participants had ALT levels assessed throughout the 12 week treatment period. Participants who had 2 consecutive assessments of ALT that were 3 x ULN or greater were recorded. The ALT ULN was 40 U/L.|up to 12 weeks|All randomized participants who received at least 1 dose of actual study treatment.||Percentage of Participants|||Number
636432|NCT02550288|Primary|Percentage of Participants Who Experience 1 or More Hepatitis-related AEs|Hepatitis-related AEs included Cholestasis, Cytolytic Hepatitis, Hepatic Cyst, Hepatic Failure, Hepatic Lesion, Hepatic Necrosis, Hepatitis, Hepatitis Cholestatic, Hepatitis Fulminant, Hepatitis Infectious, Hepatocellular Injury, Hepatomegaly, Jaundice, Jaundice Cholestatic.|up to 14 weeks|All randomized participants who received at least 1 dose of actual study treatment.||Percentage of Participants|||Number
636433|NCT02550288|Primary|Percentage of Participants Who Experience 1 or More Allergic Reaction or Rash AEs|Allergic Reaction or Rash AEs included Allergy to Arthropod Sting, Anaphylactoid Reaction, Anaphylactic Reaction, Anaphylatic Shock, Anaphylactoid Shock, Angioedema, Conjunctivitis Allergic, Contrast Media Reaction, Dermatitis, Dermatitis Allergic, Dermatitis Atopic, Dermatitis Bullous, Dermatitis Contact, Dermatitis Psoriasiform, Drug Hypersensitivity, Eczema, Eosinophila, Erythema, Eye Allergy, Face Oedema, Hypersensitivity, Mechanical Urticaria, Palmar Erythema, Periorbital Oedema, Photodermatosis, Photosensitivity Allergic reaction, Photosensitivity Reaction, Pigmentation Disorder, Pruritus, Pruritus Generalised, Rash, Rash Erythematous, Rash Follicular, Rash Generalised, Rash Maculo-Papular, Rash Papulosquamous, Rash Pruritic, Rash Pustular, Rash Vesicular, Rhinitis, Rhinitis Allergic, Rosacea, Skin Exfoliation, Skin Disorder, Skin Hyperpigmentation, Skin Lesion, Skin Mass, Skin Ulcer, Subcutaneous Nodule, Swelling Face, Systemic Lupus Erythematosus Rash, Urticaria.|up to 14 weeks|All randomized participants who received at least 1 dose of actual study treatment.||Percentage of Participants|||Number
636434|NCT02550288|Primary|Percentage of Participants Who Experience 1 or More Gallbladder-related AEs|Gallbladder-related AEs included Bile Duct Obstruction, Bile Duct Stone, Bile Duct Stenosis, Biliary Colic, Cholangitis, Cholecystectomy, Cholecystitis, Cholelithiasis, Gallbladder Disorder, Gallbladder Perforation, Hepatic Pain, and Hydrocholecystis.|up to 14 weeks|All randomized participants who received at least 1 dose of actual study treatment.||Percentage of Participants|||Number
636435|NCT02550288|Primary|Percentage of Participants Who Experience 1 or More Gastrointestinal-related Adverse Events (AEs)|Gastrointestinal-related AEs included all preferred terms within system organ class of Gastrointestinal Disorders except Chapped Lips and Toothache.|up to 14 weeks|All randomized participants who received at least 1 dose of actual study treatment.||Percentage of Participants|||Number
636436|NCT02550288|Primary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12|Participants had LDL-C levels assessed at baseline and after 12 weeks of study drug administration. The change from baseline was calculated.|Baseline and Week 12|All participants who received at least 1 dose of study treatment, and had a baseline observation or at least 1 post-baseline observation. One participant who received misallocated study medication during placebo run-in period was excluded from the main population for the analysis of efficacy data.||Percentage Change||95% Confidence Interval|Least Squares Mean
636437|NCT02550197|Primary|Percentage of Participants Reporting Solicited Injection-Site or Systemic Reaction After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route|Solicited Injection-site reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering. Grade 3: Pain, Significant; prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis, >100 mm. Grade 3 Solicited Systemic reactions: Fever, ≥ 39.0˚C; Headache, Malaise, Myalgia, and Shivering, Significant; prevents daily activity.|Day 0 up Day 7 post-vaccination|Solicited injection-site and systemic reactions were analyzed in the Safety Analysis Set.||Percentage of Participants|||Number
636438|NCT02550197|Primary|Percentage of Participants Reporting Solicited Reactions Listed in The Former Committee for Medicinal Products for Human Use Note for Guidance Within 3 Days After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route|The solicited reactions evaluated were Injection-site Induration (≥50 mm for at least 4 consecutive days), Injection-site Ecchymosis (injection site bruising), Pyrexia (recorded temperature >38.0˚C for at least 1 day), Malaise, and Shivering (rigors).|Day 0 up Day 3 post-vaccination|Solicited reactions were analyzed in the Safety Analysis Set.||Percentage of Participants|||Number
636439|NCT02550197|Primary|Geometric Mean Titer Ratios of Influenza Virus Antibodies After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route|Immunogenicity was evaluated using the hemagglutination inhibition (HAI) technique.|Day 0 (pre-vaccination) and Day 21 post-vaccination|Geometric mean titer ratios of influenza antibodies were assessed in the Immunogenicity Analysis Set.||Titer ratio||95% Confidence Interval|Geometric Mean
636440|NCT02550197|Primary|Percentage of Participants Achieving Seroconversion or Significant Increase Against Influenza Antigens After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route|Immunogenicity was evaluated using the hemagglutination inhibition (HAI) technique. Seroconversion was defined as titers < 10 (1/dil) on Day 0 and post-injection titer ≥ 40 (1/dil) on Day 21, and Significant increase was defined as titers ≥ 10 (1/dil) on Day 0 and ≥ 4-fold increase of post-injection titer on Day 21.|Day 21 post-vaccination|Immunogenicity was assessed in the Immunogenicity Analysis Set.||Percentage of Participants|||Number
636441|NCT02550197|Primary|Percentage of Participants With Influenza Antibodies Titers < 10 (1/Dil) Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route|Immunogenicity was evaluated using the hemagglutination inhibition (HAI) technique.|Day 0 (pre-vaccination) and Day 21 post-vaccination|Immunogenicity was assessed in the Immunogenicity Analysis Set.||Percentage of Participants|||Number
636442|NCT02550197|Primary|Percentage of Participants Achieving Seroprotection Against Influenza Antigens Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route|Immunogenicity was evaluated using the hemagglutination inhibition (HAI) technique. Seroprotection was defined as titers ≥ 40 (1/dil) on Day 0 and Day 21.|Day 0 (pre-vaccination) and Day 21 post-vaccination|Seroprotection was assessed in the Immunogenicity Analysis Set.||Percentage of Participants|||Number
637138|NCT02506257|Other Pre-specified|Ocular Surface Disease Index-OSDI|Change from baseline OSDI at D 14. Score range was betwwen 0-100. An increase of OSDI values with treatment represent a negative outcome.|Baseline and Day 14|||scores on a scale||Standard Deviation|Mean
636443|NCT02550197|Primary|Geometric Mean Titers of Influenza Antibodies Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route|Immunogenicity was evaluated using the hemagglutination inhibition (HAI) technique.|Day 0 (pre-vaccination) and Day 21 post-vaccination|Geometric mean titers of influenza antibodies were assessed in the Immunogenicity Analysis Set.||Titers (1/dilution)||95% Confidence Interval|Geometric Mean
636444|NCT02550132|Primary|Vertebral Displacement of the Eighth Thoracic Vertebra|Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter|During the 300N spinal manipulation procedure, assessed up to 2 seconds following thrust onset|||cm||Standard Error|Mean
636445|NCT02550132|Primary|Vertebral Displacement of the Seventh Thoracic Vertebra|Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter|During the 300N spinal manipulation procedure, assessed up to 2 seconds following thrust onset|||cm||Standard Error|Mean
636446|NCT02550132|Primary|Vertebral Displacement of the Sixth Thoracic Vertebra|Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter|During the 300N spinal manipulation procedure, assessed up to 2 seconds following thrust onset|||cm||Standard Error|Mean
636447|NCT02550132|Primary|Vertebral Displacement of the Eighth Thoracic Vertebra|Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter|During the 250N spinal manipulation procedure, assessed up to 2 seconds following thrust onset|||cm||Standard Error|Mean
636448|NCT02550132|Primary|Vertebral Displacement of the Seventh Thoracic Vertebra|Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter|During the 250N spinal manipulation procedure, assessed up to 2 seconds following thrust onset|||cm||Standard Error|Mean
636449|NCT02550132|Primary|Vertebral Displacement of the Sixth Thoracic Vertebra|Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter|During the 250N spinal manipulation procedure, assessed up to 2 seconds following thrust onset|||cm||Standard Error|Mean
636450|NCT02550132|Primary|Vertebral Displacement of the Eighth Thoracic Vertebra|Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter|During the 200N spinal manipulation procedure, assessed up to 2 seconds following thrust onset|||cm||Standard Error|Mean
636451|NCT02550132|Primary|Vertebral Displacement of the Seventh Thoracic Vertebra|Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter|During the 200N spinal manipulation procedure, assessed up to 2 seconds following thrust onset|||cm||Standard Error|Mean
636452|NCT02550132|Primary|Vertebral Displacement of the Sixth Thoracic Vertebra|Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter|During the 200N spinal manipulation procedure, assessed up to 2 seconds following thrust onset|||cm||Standard Error|Mean
636453|NCT02550132|Primary|Vertebral Displacement of the Eighth Thoracic Vertebra|Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter|During the 150N spinal manipulation procedure, assessed up to 2 seconds following thrust onset|||cm||Standard Error|Mean
636454|NCT02550132|Primary|Vertebral Displacement of the Seventh Thoracic Vertebra|Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter|During the 150N spinal manipulation procedure, assessed up to 2 seconds following thrust onset|||cm||Standard Error|Mean
636455|NCT02550132|Primary|Vertebral Displacement of the Sixth Thoracic Vertebra|Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter|During the 150N spinal manipulation procedure, assessed up to 2 seconds following thrust onset|||cm||Standard Error|Mean
636456|NCT02550132|Primary|Right T8 Normalized Root Mean Square (RMS) Value|Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.|During the 300N spinal manipulation procedure, assessed up to 2 seconds following thrust onset|||ratio||Standard Error|Mean
636457|NCT02550132|Primary|Right T6 Normalized Root Mean Square (RMS) Value|Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.|During the 300N spinal manipulation procedure, assessed up to 2 seconds following thrust onset|||ratio||Standard Error|Mean
636458|NCT02550132|Primary|Left T8 Normalized Root Mean Square (RMS) Value|Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.|During the 300N spinal manipulation procedure, assessed up to 2 seconds following thrust onset|||ratio||Standard Error|Mean
636459|NCT02550132|Primary|Left T6 Normalized Root Mean Square (RMS) Value|Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.|During the 300N spinal manipulation procedure, assessed up to 2 seconds following thrust onset|||ratio||Standard Error|Mean
636460|NCT02550132|Primary|Right T8 Normalized Root Mean Square (RMS) Value|Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.|During the 250N spinal manipulation procedure, assessed up to 2 seconds following thrust onset|||ratio||Standard Error|Mean
636461|NCT02550132|Primary|Right T6 Normalized Root Mean Square (RMS) Value|Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.|During the 250N spinal manipulation procedure, assessed up to 2 seconds following thrust onset|||ratio||Standard Error|Mean
636462|NCT02550132|Primary|Left T8 Normalized Root Mean Square (RMS) Value|Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.|During the 250N spinal manipulation procedure, assessed up to 2 seconds following thrust onset|||ratio||Standard Error|Mean
636463|NCT02550132|Primary|Left T6 Normalized Root Mean Square (RMS) Value|Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.|During the 250N spinal manipulation procedure, assessed up to 2 seconds following thrust onset|||ratio||Standard Error|Mean
636464|NCT02550132|Primary|Right T8 Normalized Root Mean Square (RMS) Value|Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.|During the 200N spinal manipulation procedure, assessed up to 2 seconds following thrust onset|||ratio||Standard Error|Mean
636465|NCT02550132|Primary|Right T6 Normalized Root Mean Square (RMS) Value|Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.|During the 200N spinal manipulation procedure, assessed up to 2 seconds following thrust onset|||ratio||Standard Error|Mean
636466|NCT02550132|Primary|Left T8 Normalized Root Mean Square (RMS) Value|Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.|During the 200N spinal manipulation procedure, assessed up to 2 seconds following thrust onset|||ratio||Standard Error|Mean
636467|NCT02550132|Primary|Left T6 Normalized Root Mean Square (RMS) Value|Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.|During the 200N spinal manipulation procedure, assessed up to 2 seconds following thrust onset|||ratio||Standard Error|Mean
636468|NCT02550132|Primary|Right T8 Normalized Root Mean Square (RMS) Value|Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.|During the 150N spinal manipulation procedure, assessed up to 2 seconds following thrust onset|||ratio||Standard Error|Mean
636469|NCT02550132|Primary|Right T6 Normalized Root Mean Square (RMS) Value|Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.|During the 150N spinal manipulation procedure, assessed up to 2 seconds following thrust onset|||ratio||Standard Error|Mean
636470|NCT02550132|Primary|Left T8 Normalized Root Mean Square (RMS) Value|Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.|During the 150N spinal manipulation procedure, assessed up to 2 seconds following thrust onset|||ratio||Standard Error|Mean
636471|NCT02550132|Primary|Left T6 Normalized Root Mean Square (RMS) Value|Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.|During the 150N spinal manipulation procedure, assessed up to 2 seconds following thrust onset|||ratio||Standard Error|Mean
636472|NCT02549027|Secondary|Change From Baseline in CRT Following Single Doses of MK-6096 and Placebo|"CRT assessment used in this study is a two-choice, computer-controlled test in which the participant responds to stimulus words presented on the screen of a laptop computer. During the test either the word NO or the word YES is presented on the screen and the participant is instructed to press the corresponding button as quickly as possible. There are 50 trials for which each stimulus word is chosen randomly with equal probability and there is a varying inter-stimulus interval. The mean reaction time of accurate responses is determined. The assessment is performed pre-dose and at 10 hours post dose. The outcome measure is change from baseline to post dose in reaction time."|Pre-dose and 10 hours post dose, within each treatment period|Per-Protocol. Note: Data included are those obtained from subjects during MK-6096 dose in Period 5 and during administration of placebo in any period. 1 subject took placebo within Periods 1-4 and also in Period 5. Data for both administrations of placebo are included (i.e., for placebo, analysis includes 21 observations from 20 subjects)||milliseconds||95% Confidence Interval|Mean
636473|NCT02549027|Secondary|Change From Baseline in Choice Reaction Time (CRT) Following Single Doses of MK-1064 and Placebo|"CRT assessment used in this study is a two-choice, computer-controlled test in which the participant responds to stimulus words presented on the screen of a laptop computer. During the test either the word NO or the word YES is presented on the screen and the participant is instructed to press the corresponding button as quickly as possible. There are 50 trials for which each stimulus word is chosen randomly with equal probability and there is a varying inter-stimulus interval. The mean reaction time of accurate responses is determined. The assessment is performed pre-dose and at 10 hours post dose. The outcome measure is change from baseline to post dose in reaction time."|Pre-dose and 10 hours post dose, within each treatment period|Per-Protocol. Note: Data included are those obtained from subjects during administration of MK-1064 doses in Period 1-4 and during administration of placebo in Period 1-4||milliseconds||95% Confidence Interval|Mean
636474|NCT02549027|Secondary|WASO Following Single Doses of MK-6096 and Placebo|WASO is measured during overnight sleep laboratory (PSG) assessment and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning.|1 to 9 hours post dose, within each treatment period|Per-Protocol. Note: Data included are those obtained from subjects during MK-6096 dose in Period 5 and during administration of placebo in any period. 1 subject took placebo within Periods 1-4 and also in Period 5. Data for both administrations of placebo are included (i.e., for placebo, analysis includes 21 observations from 20 subjects)||minutes||95% Confidence Interval|Geometric Mean
636475|NCT02549027|Secondary|Wake Time After Sleep Onset (WASO) Following Single Doses of MK-1064 and Placebo|WASO is measured during overnight sleep laboratory (PSG) assessment and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning.|1 to 9 hours post dose, within each treatment period|Per-Protocol. Note: Data included are those obtained from subjects during administration of MK-1064 doses in Period 1-4 and during administration of placebo in Period 1-4||minutes||95% Confidence Interval|Geometric Mean
636476|NCT02549027|Primary|Number of Participants Who Discontinued Study Due to an AE|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE.|Up to 14 days after the last dose of study drug (Up to approximately 42 days)|All Participants as Treated – all participants who received at least one dose of study drug.||participants|||Number
636477|NCT02549027|Primary|Number of Participants With Adverse Events (AEs)|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE.|Up to 14 days after the last dose of study drug (Up to approximately 42 days)|All Participants as Treated – all participants who received at least one dose of study drug.||participants|||Number
636478|NCT02549027|Primary|LPS Following Single Doses of MK-6096 and Placebo|LPS is measured during overnight sleep laboratory (PSG) assessment and is defined as the duration of time from the beginning of PSG assessment to the first interval of 10 consecutive minutes of sleep.|1 to 9 hours post dose, within each treatment period|Per-Protocol. Note: Data included are those obtained from subjects during MK-6096 dose in Period 5 and during administration of placebo in any period. 1 subject took placebo within Periods 1-4 and also in Period 5. Data for both administrations of placebo are included (i.e., for placebo, analysis includes 21 observations from 20 subjects)||minutes||95% Confidence Interval|Geometric Mean
636479|NCT02549027|Primary|Latency to Persistent Sleep (LPS) Following Single Doses of MK-1064 and Placebo|LPS is measured during overnight sleep laboratory (polysomnography [PSG]) assessment and is defined as the duration of time from the beginning of PSG assessment to the first interval of 10 consecutive minutes of sleep.|1 to 9 hours post dose, within each treatment period|Per-Protocol. Note: Data included are those obtained from subjects during administration of MK-1064 doses in Period 1-4 and during administration of placebo in Period 1-4||minutes||95% Confidence Interval|Geometric Mean
636480|NCT02549014|Secondary|Apparent Terminal Half-life (t1/2) Following Single Doses of MK-1064|t1/2 is the elimination half-life of study drug. t1/2 is the time it takes for half of the study drug (MK-1064) in the blood plama to dissipate.|Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24 and 48 hours post dose (all Periods); 72 hours post dose (Periods 3 and 4 only)|All participants who received ≥1 dose of MK-1064.||hr||Standard Deviation|Geometric Mean
636481|NCT02549014|Secondary|Time to Cmax (Tmax) Following Single Doses of MK-1064|Tmax is the amount of time to reach maximum (peak) plasma drug concentration following drug administration.|Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24 and 48 hours post dose (all Periods); 72 hours post dose (Periods 3 and 4 only)|All participants who received ≥1 dose of MK-1064.||hr||Full Range|Median
636482|NCT02549014|Secondary|Maximum Observed Plasma Concentration (Cmax) Following Single Doses of MK-1064|Cmax is the maximum (peak) concentration of study drug (MK-1064) observed in blood plasma.|Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24 and 48 hours post dose (all Periods); 72 hours post dose (Periods 3 and 4 only)|All participants who received ≥1 dose of MK-1064.||µmol/L||Standard Deviation|Geometric Mean
636483|NCT02549014|Secondary|Area Under the Plasma Drug Concentration-time Curve From Time Zero to Last Measurable Concentration (AUC0-last) Following Single Doses of MK-1064|AUC0-last is the area under the plasma concentration-time curve from time zero to time of last measurable concentration. It is is a measure of the amount of study drug (MK-1064) in the blood plasma from pre-dose until the last measurable concentration of study drug could be determined.|Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24 and 48 hours post dose (all Periods); 72 hours post-dose (Periods 3 and 4 only)|All participants who received ≥1 dose of MK-1064.||µmol*hr/L||Standard Deviation|Geometric Mean
636484|NCT02549014|Primary|Average Plasma Concentration From Time Zero to 4 Hours (Area Under the Plasma Drug Concentration-time Curve From Time Zero to 4 Hours [AUC0-4hr]) Following Single Doses of MK-1064|AUC0-4hr is the area under the plasma concentration-time curve from time 0 to 4 hours post-dose. This is a measure of the average amount of study drug (MK-1064) in the blood plasma over a period of 4 hours after the dose.|Pre-dose and 0.5, 1, 2, 3 and 4 hours post-dose|All participants who received ≥1 dose of MK-1064.||µmol*hr/L||Standard Deviation|Geometric Mean
636485|NCT02549014|Primary|Number of Participants Who Discontinued Study Due to an AE|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study drug, whether or not considered related to the use of study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of study drug, is also an AE.|Up to 14 days after the last dose of study drug (Up to approximately 60 days)|All participants who received ≥1 dose of study drug.||Participants|||Number
636486|NCT02549014|Primary|Number of Participants Who Experienced One or More Adverse Events (AEs)|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study drug, whether or not considered related to the use of study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of study drug, is also an AE.|Up to 14 days after the last dose of study drug (Up to approximately 60 days)|All participants who received ≥1 dose of study drug.||Participants|||Number
636487|NCT02548156|Secondary|Concentrations of Fluoride and Calcium Ions in the Initial Expectorate, De-ionised Water Rinse Post Brushing Expectorate, and 60 Minutes Post Brushing Following Administration of Orange Juice or De-ionised Water Rinse|Concentration of fluoride and calcium ions in the initial expectorate, de-ionized water rinse post brushing expectorate, and 60 minutes post brushing following administration of orange juice or de-ionised water rinse|up to 60 minutes|The Per Protocol (PP) population was a subset of the ITT population (All randomized participants who had received study treatment and have at least one post-baseline efficacy measurement). n= number of participants analyzed for this outcome.||ppm||Standard Deviation|Mean
636488|NCT02548156|Secondary|Concentrations of Fluoride and Calcium Ions in Saliva Following Administration of the Orange Juice or De-ionised Water Rinse|Concentration of fluoride and calcium ions in saliva following a rinse with either de ionised water or OJ 60 minutes after a single brushing with a fluoride dentifrice|60 minutes|The Per Protocol (PP) population was a subset of the ITT population (All randomized participants who had received study treatment and have at least one post-baseline efficacy measurement). n= number of participants analyzed for this outcome.||ppm||Standard Error|Least Squares Mean
636489|NCT02548156|Secondary|Concentrations of Fluoride and Calcium Ions in Saliva Post Brushing Prior to Administration of Orange Juice or De-ionised Water Rinse|Concentration of fluoride and calcium ions in saliva at baseline, 1, 5, 10, 15, 30 and 60 minutes (for calcium only) after a single brushing with a fluoride dentifrice|up to 60 minutes|The Per Protocol (PP) population was a subset of the ITT population (All randomized participants who had received study treatment and have at least one post-baseline efficacy measurement). n= number of participants analyzed for this outcome.||ppm||Standard Error|Mean
636517|NCT02547454|Primary|Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 10-12|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|At Months 10-12|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.||Percentage of participants|||Number
636490|NCT02548156|Primary|Concentrations of Fluoride Ions in Saliva 60 Minutes Post Brushing Prior to Administration of the Orange Juice or De-ionised Water Rinse|Concentration of fluoride ions in saliva at 60 minutes after a single brushing with a fluoride dentifrice prior to rinsing with either de-ionised (DI) water or orange juice (OJ). Descriptive data is presented as least square (LS) mean and standard error (SE). SE for Fluoride is the SE of the raw mean.|60 minutes|The Per Protocol (PP) population was a subset of the ITT population (All randomized participants who had received study treatment and have at least one post-baseline efficacy measurement). n= number of participants analyzed for this outcome.||parts per million(ppm)||Standard Error|Least Squares Mean
636491|NCT02547714|Secondary|Percentage of Participants Achieving DLQI 0 or 1|"The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral warts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). Not relevant is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment."|Week 16|The full analysis set, which included all participants who received at least one dose of study drug, was analyzed.||Percentage of participants|||Number
636492|NCT02547714|Secondary|Mean Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score|"The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral warts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). Not relevant is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative mean percentage change from baseline indicates improvement."|Week 16|The full analysis set was considered for the analysis. Only participants who had both baseline and week 16 values were included in the analysis. The full analysis set included all participants who received at least one dose of study drug.||Percent change||Standard Deviation|Mean
636493|NCT02547714|Secondary|Percentage of Participants Achieving PASI 90 and Investigator’s Global Assessment (IGA) of 0 or 1 Response|"PASI is a combined assessment of a lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). The body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for a final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area * area score weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).
PASI 90 was defined as participants achieving >= 90% improvement from baseline. The IGA scale is static, i.e. it referred exclusively to the participant's disease at the time of assessment and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe."|Week 16|The full analysis set, which included all participants who received at least one dose of study drug, was analyzed.||Percentage of participants|||Number
636494|NCT02547714|Secondary|Percentage of Participants Achieving PASI 50 or PASI 75|"PASI is a combined assessment of a lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). The body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for a final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area * area score weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).
PASI 50 and PASI 75 were defined as participants achieving >= 50% or >= 75% improvement from baseline, respectively."|Week 4|The full analysis set, which included all participants who received at least one dose of study drug, was analyzed.||Percentage of participants|||Number
636495|NCT02547714|Secondary|Mean Percent Change From Baseline in PASI Score|PASI is a combined assessment of a lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). The body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for a final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area * area score weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). A negative change from baseline indicates improvement.|Week 4|The full analysis set, which included all participants who received at least one dose of study drug, was analyzed.||Percent change||Standard Deviation|Mean
636496|NCT02547714|Primary|Percentage of Participants Who Achieved ≥ 75% Psoriasis Area and Severity Index (PASI 75)|PASI is a combined assessment of a lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). The body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for a final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area * area score weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). PASI 75 was defined as participants achieving >= 75% improvement from baseline.|Week 16|The full analysis set, which included all participants who received at least one dose of study drug, was analyzed.||Percentage of participants|||Number
636497|NCT02547454|Secondary|Percentage of Participants With Iron Replacement|Iron replacement was given to the participants either in oral iron replacement or intravenous replacement or both.|Up to 36 Months|Analysis population included all enrolled participants.||Percentage of participants|||Number
636498|NCT02547454|Secondary|Percentage of Participants With Dose 0|Percentage of participants who did not use methoxy polyethylene glycol-epoetin beta (Dose 0) at atleast one visit during study period.|Up to 36 Months|Analysis population included all enrolled participants.||Percentage of participants|||Number
636584|NCT02540850|Secondary|Consistency (the Overall Ratio of True Positive and True Negative)|The overall consistency ratio of true positive and true negative, i.e. (true positive+true negative)/total number of cases|1 year|||percentage of true pos&negs in all cases|||Number
636499|NCT02547454|Secondary|Number of Dose Adaptations|Total number of changes (increase or decrease) in daily methoxy polyethylene glycol-epoetin beta doses. The reasons for dose-adaptations included: inflammation or infection; kidney function decline; over-response; iron deficiency; insufficient response; adverse effect; start of maintenance dose; kidney function improvement; re-introduction of treatment; and others (other reasons than specified).|Up to 36 Months|Analysis population included all enrolled participants.||Events|||Number
636500|NCT02547454|Secondary|Median Dose of Methoxy Polyethylene Glycol-Epoetin Beta|Median monthly dose of methoxy polyethylene glycol-epoetin beta administered in the study up to 36 months.|Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21 and After 21 Months up to 36 Months|Analysis population included all enrolled participants. Here, n signifies participants with available data at specified time-point.||microgram||Full Range|Median
636501|NCT02547454|Secondary|Average Dose of Methoxy Polyethylene Glycol-Epoetin Beta|Average dose of methoxy polyethylene glycol-epoetin beta administered at Baseline|Baseline|Analysis population included all enrolled participants.||microgram||Standard Deviation|Mean
636502|NCT02547454|Secondary|Median Time in Which Hb Value Was Maintained Within Target Range of 100-130 g/L||Up to 36 Months|Analysis population included all enrolled participants.||Months||Full Range|Median
636503|NCT02547454|Secondary|Median Time in Which Hb Value Was Maintained Within Target Range of 110-120 g/L||Up to 36 Months|Analysis population included all enrolled participants.||Months||Full Range|Median
636504|NCT02547454|Primary|Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) After 21 Months up to 36 Months|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|After 21 Months up to 36 Months|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.||Percentage of participants|||Number
636505|NCT02547454|Primary|Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 19-21|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|At Months 19-21|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.||Percentage of participants|||Number
636506|NCT02547454|Primary|Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 16-18|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|At Months 16-18|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.||Percentage of participants|||Number
636507|NCT02547454|Primary|Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 13-15|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|At Months 13-15|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.||Percentage of participants|||Number
636508|NCT02547454|Primary|Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 10-12|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|At Months 10-12|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.||Percentage of participants|||Number
636509|NCT02547454|Primary|Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 7-9|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|At Months 7-9|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.||Percentage of participants|||Number
636510|NCT02547454|Primary|Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 4-6|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|At Months 4-6|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.||Percentage of participants|||Number
636511|NCT02547454|Primary|Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 1-3|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|At Months 1-3|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.||Percentage of participants|||Number
636512|NCT02547454|Primary|Percentage of Participants With Hemoglobin (Hb) Value Within the Target Range (100 to 130 g/L) at Baseline|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|At Baseline|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.||Percentage of participants|||Number
636513|NCT02547454|Primary|Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) After 21 Months up to 36 Months|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|After 21 Months up to 36 Months|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.||Percentage of participants|||Number
636514|NCT02547454|Primary|Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 19-21|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|At Months 19-21|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.||Percentage of participants|||Number
636515|NCT02547454|Primary|Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 16-18|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|At Months 16-18|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.||Percentage of participants|||Number
636516|NCT02547454|Primary|Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 13-15|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|At Months 13-15|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.||Percentage of participants|||Number
657719|NCT01916681|Primary|Severe RDS||enrollment through neonatal discharge|||participants|||Number
636518|NCT02547454|Primary|Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 7-9|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|At Months 7-9|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.||Percentage of participants|||Number
636519|NCT02547454|Primary|Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 4-6|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|At Months 4-6|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.||Percentage of participants|||Number
636520|NCT02547454|Primary|Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 1-3|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|At Months 1-3|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.||Percentage of participants|||Number
636521|NCT02547454|Primary|Percentage of Participants With Hemoglobin (Hb) Value Within the Target Range (110 to 120 Grams Per Liter [g/L]) at Baseline|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|Baseline|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.||Percentage of participants|||Number
636522|NCT02547064|Secondary|Airway Injury|Larynx injury is assessed.|Intraoperative intubation|||Participants|||Count of Participants
636523|NCT02547064|Secondary|Heart Rate|Heart rates are measured before and 2 min after intubation.|Intraoperative intubation|||beats per minute||Standard Deviation|Mean
636524|NCT02547064|Secondary|Mean Blood Pressure|Mean blood pressure is measured before and 2 min after intubation.|Intraoperative intubation|||mmHg||Standard Deviation|Mean
636525|NCT02547064|Secondary|Postoperative Sore Throat Measured Using Visual Analogue Scale|Postoperative sore throat will be measured using visual analogue scale (0:no pain, 100: worst pain imaginable)|at 1, 24 hr postoperatively|||units on a scale||Standard Deviation|Mean
636526|NCT02547064|Secondary|Thyromental Distance|The thyromental distance was measured.|Intraoperative anesthetic induction|||mm||Standard Deviation|Mean
636527|NCT02547064|Secondary|Mallampati Grade|The Mallapati grade was assessed as I/II/III/IV (I: Soft palate, uvula, fauces, pillars visible, II: Soft palate, uvula, fauces visible, III: Soft palate, base of uvula visible, IV: Only hard palate visible). Grade I was considered better outcomes.|Intraoperative anesthetic induction|||Participants|||Count of Participants
636528|NCT02547064|Secondary|Cormack-Lehan Grade|The grade of Cormack-Lehan was assessed as I/II/III/IV (I: Full view of glottis, II: Partial view of glottis, III: Only epiglottis seen, none of glottis seen, IV: Neither glottis nor epiglottis seen). Grade I was considered better outcomes.|Intraoperative intubation|||Participants|||Count of Participants
636529|NCT02547064|Secondary|Number of Participants for Whom External Laryngeal Manipulation Was Necessary|External laryngeal manipulation is defined as the compression of neck for the facilitation of laryngeal view. Number of participants for whom external laryngeal manipulation was necessary will be measured.|Intraoperative intubation|||Participants|||Count of Participants
636530|NCT02547064|Secondary|Difficulty of Intubation Measured Using Visual Analogue Scale|Difficulty of intubation will be measured using visual analogue scale (0:easiest, 100:most difficult).|Intraoperative intubation|||units on a scale||Standard Deviation|Mean
636531|NCT02547064|Secondary|Success Rate of Intubation|The number of patients in which the intubation was successful at the first time.|Intraoperative intubation|||Participants|||Count of Participants
636532|NCT02547064|Primary|Time to Intubation|Time from the insertion of the Glidescope blade to the measurement of end tidal CO2 (>30 mmHg)|Intraoperative intubation|||sec||Standard Deviation|Mean
636533|NCT02545543|Secondary|Immunogenicity Endpoint: Geometric Mean Fold Increase (GMFI)|"The humoral immune response was assessed for Seqirus QIV & comparator QIV. Serum HI titers against the 4 influenza vaccine strains was used to calculate:
- Geometric mean fold increase (GMFI): geometric mean fold titer rise from Day 1 to Exit Visit"|28 days after last vaccination.|The Per-Protocol Population comprised all subjects in the Evaluable Population who did not have any protocol deviations that were medically assessed as potentially impacting on immunogenicity results.||Fold Change Titer (GMFI)||95% Confidence Interval|Geometric Mean
636534|NCT02545543|Secondary|Immunogenicity Endpoint: Seroprotection Rate|"The humoral immune response was assessed for Seqirus QIV & comparator QIV. Serum HI titers against the 4 influenza vaccine strains was used to calculate:
- The % of subjects with a titer ≥40 (seroprotection rates) at Day 1 and at Exit Visit"|28 days after last vaccination.|The Per-Protocol Population comprised all subjects in the Evaluable Population who did not have any protocol deviations that were medically assessed as potentially impacting on immunogenicity results||percentage of participants||95% Confidence Interval|Number
636535|NCT02545543|Secondary|Immunogenicity Endpoint: Seroconversion Rate (SCR)|"The humoral immune response was assessed for Seqirus QIV & comparator QIV. Serum HI titers against the 4 influenza vaccine strains was used to calculate:
- SCRs: % of subjects with either a prevaccination HI titer < 1:10 and a postvaccination HI titer ≥ 1:40 or a prevaccination titer ≥ 1:10 and a ≥ 4-fold increase in postvaccination titer"|28 days after last vaccination.|The Per-Protocol Population comprised all subjects in the Evaluable Population who did not have any protocol deviations that were medically assessed as potentially impacting on immunogenicity results.||percentage of participants||95% Confidence Interval|Number
636536|NCT02545543|Secondary|Immunogenicity Endpoint: GMTs - Geometric Mean of HI Titers Prevaccination (Day 1) and Postvaccination (Study Exit Visit)|"The humoral immune response was assessed for Seqirus QIV & comparator QIV. Serum HI titers against the 4 influenza vaccine strains was used to calculate:
- Geometric mean of HI titers prevaccination & postvaccination"|28 days after last vaccination.|The Per-Protocol Population comprised all subjects in the Evaluable Population who did not have any protocol deviations that were medically assessed as potentially impacting on immunogenicity results||Titer||95% Confidence Interval|Geometric Mean
636537|NCT02545543|Secondary|Safety Endpoint: The Frequency of Serious Adverse Events (SAEs).|Frequency of serious adverse events (SAEs) for 180 days after the last vaccination dose.|180 days after the last vaccination dose.|The Overall Safety Population comprises all subjects in the FAS who received at least one dose or partial dose of Study Vaccine and provided any evaluable follow-up safety data||participants|||Number
636538|NCT02545543|Secondary|Safety Endpoint: The Frequency and Severity of Unsolicited Adverse Events (AEs).|Frequency and severity of unsolicited AEs for at least 28 days (ie, day of vaccination and 27 subsequent days) after each vaccination dose|28 days after each vaccination.|The Overall Safety Population comprises all subjects in the FAS who received at least one dose or partial dose of Study Vaccine and provided any evaluable follow-up safety data.||participants|||Number
636539|NCT02545543|Secondary|Safety Endpoint: The Frequency of Cellulitis-like Reaction.|Frequency of cellulitis-like reaction for at least 28 days after each vaccination dose|28 days after each vaccination.|The Solicited Safety Population comprises all subjects in the FAS who received at least one dose or partial dose of Study Vaccine and provided any evaluable data on solicited events.||participants|||Number
636540|NCT02545543|Secondary|Safety Endpoint: The Frequency and Severity of Solicited Systemic Adverse Events (AEs).|Frequency and severity of solicited systemic adverse events (AEs) for 7 days (ie, day of vaccination and 6 subsequent days) after each vaccination dose|7 days after each vaccination.|The Solicited Safety Population comprised all subjects in the FAS who received at least one dose or partial dose of Study Vaccine and provided any evaluable data on solicited events.||participants|||Number
636541|NCT02545543|Secondary|Safety Endpoint: The Frequency and Severity of Solicited Local Adverse Reactions.|Frequency and severity of solicited local adverse reactions (AEs) for 7 days (ie, day of vaccination and 6 subsequent days) after each vaccination dose|7 days after each vaccination.|The Solicited Safety Population comprises all subjects in the FAS who received at least one dose or partial dose of Study Vaccine and provided any evaluable data on solicited events.||participants|||Number
636542|NCT02545543|Primary|The Difference in Seroconversion Rate (SCR) for Each Virus Strain.|Noninferiority of Seqirus QIV compared to Comparator QIV was assessed by the eight co-primary endpoints of HI geometric mean titer (GMT) and seroconversion rate (SCR) for each viral strain. The rate of SCR is defined as the percentage of subjects with either a prevaccination HI titer < 1:10 and a postvaccination HI titer ≥ 1:40, or a prevaccination HI titer ≥ 1:10 and a ≥ 4-fold increase in postvaccination HI titer. For the SCR comparison, the difference between the SCR for each virus strain will be determined.|28 days after last vaccination.|The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.||percentage of participants||95% Confidence Interval|Number
636543|NCT02545543|Primary|The Geometric Mean Titer (GMT) Ratio of Each Virus Strain.|Noninferiority of Seqirus QIV compared to comparator QIV was assessed by the eight co-primary endpoints of hemagglutination inhibition (HI) antibody geometric mean titer (GMT) and seroconversion rate (SCR) for each viral strain included in the vaccines. The GMT ratio is defined as the geometric mean of the postvaccination HI titer for the US-licensed comparator QIV over the geometric mean of the postvaccination HI titer for Seqirus QIV.|28 days after last vaccination.|The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.||Ratio||95% Confidence Interval|Geometric Mean
636544|NCT02545322|Secondary|Volumetric Changes|"Percent changes in the volume of the Planning Target Volume (PTV). The Planning Target Volume is a volume, consisting of the clinical target volume and additional safety margins, that should receive a certain radiation dose. The volumetric changes of the PTV throughout the course of Radiation therapy are evaluated. A significant change in the volume of the PTV (measured in ccm) might be an indicator for possible undesireable dosimetric alterations."|week 5|||percent||Standard Deviation|Mean
636545|NCT02545322|Primary|Planning Target Volume (PTV) Coverage Parameter D98%|"Dose coverage of the planning target volume: Number of participants with a decrease in the planning target volume (PTV) coverage (D98%) above 5%. The Parameter D98% denotes the minimum dose to 98% of the volume according to the ICRU (International Commission on Radiation Units & Measurements) Report No. 62. It is a widely accepted classification index for dose coverage.
The Planing Target Volume is a volume, consisting of the clinical target volume and additional safety margins, that should receive a certain radiation dose."|week 5|||participants|||Number
636546|NCT02543918|Primary|Percentage of Participants With an Immune Response to Tetanus and Pneumococcal Vaccinations|"Responder to tetanus vaccine defined as a post-vaccination anti-tetanus antibody concentration of >=1.0 (International Unit (IU) and a >=1.5-fold increase (50% increase) from baseline if the pre-vaccination concentration is <=1.0 at baseline OR a >=2.5-fold increase (150% increase) from baseline if the pre-vaccination concentration is > 1.0 IU at baseline.
Responder to the pneumococcal vaccine is defined as a >=2-fold increase (100% increase) from baseline in anti-pneumococcal antibody concentrations against >50% of the 23 serotypes."|Week 6|All randomized participants who completed the study.||percentage of participants|||Number
636547|NCT02543437|Secondary|Wear Rate(%)|Retrospective comparison of the wear amount over time between X3 liner and Crossfire insert.|1 year, 2 years, 3 years and 5 years after surgery||||||
636548|NCT02543437|Primary|Lift Off Distance in Dislocation Maneuver(mm)|Measure and compare the lift off distance in dislocation maneuver using femoral head trials of 36mm- and 28mm-diameter during intraoperative confirmation.|Intraoperative|participants with available data : 100 hips in 100 participants.||mm|Participants|Standard Deviation|Mean
636549|NCT02543437|Primary|Range of Motion(ROM) (Degree)|Measure and compare the ROM using femoral head trials of 36mm- and 28mm-diameter during intraoperative confirmation.|Intraoperative|Comparison between 28mm liner and 36mm line. Participants with available data : 119 hips in 117 participants.||Degree|Participants|Standard Deviation|Mean
636550|NCT02542943|Secondary|Change From Baseline in VRS of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse) at Week 8|Participants rated the intensity of their response to the evaporative (air) stimulus using a 10 point VRS. The Participants were asked to rate their pain on a scale of 1 (“No Pain”) to 10 (“Intense Pain”). A reduction in the score is indicative of an improvement in sensitivity.|Baseline, Week 8|ITT population included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.||score on a scale||Standard Deviation|Mean
636585|NCT02540850|Secondary|Positivity Rate (The Ratio of Positive mSEPT9 Results in the Population)|the ratio of positive cases in all cases|1 year|||percentage of positives in each group|||Number
637787|NCT02471612|Secondary|Need for Post Operative Inotropic Support|Number of patients needing post-operative inotropic support|30 days|||participants|||Number
636551|NCT02542943|Secondary|Change From Baseline in Visual Rating Scale (VRS) of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse) at Week 4|Participants rated the intensity of their response to the evaporative (air) stimulus using a 10 point VRS. The Participants were asked to rate their pain on a scale of 1 (“No Pain”) to 10 (“Intense Pain”). A reduction in the score is indicative of an improvement in sensitivity.|Baseline, Week 4|ITT population included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.||score on a scale||Standard Deviation|Mean
636552|NCT02542943|Secondary|Change From Baseline in Tactile Threshold (g) of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse at Week 8|The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force has reached. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g. However, in situations where participants did not give a ‘yes’ response at force of 80g, the tactile threshold was recorded as >80g. For analysis purposes values recorded as >80g were treated as 90g values.|Baseline, Week 8|ITT population included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.||g||Full Range|Median
636553|NCT02542943|Secondary|Change From Baseline in Tactile Threshold (Gram [g]) of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse at Week 4|The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force has reached. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g. However, in situations where participants did not give a ‘yes’ response at force of 80g, the tactile threshold was recorded as >80g. For analysis purposes values recorded as >80g were treated as 90g values.|Baseline, Week 4|ITT population included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.||g||Full Range|Median
636554|NCT02542943|Secondary|Change From Baseline in Schiff Sensitivity Score of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse at Week 4|The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicate improvement in sensitivity.|Baseline, Week 4|ITT population included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.||score on a scale||Standard Deviation|Mean
636555|NCT02542943|Secondary|Change From Baseline in Schiff Sensitivity Score of Two Experimental Oral Rinses 1 and 2 at Week 8|The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicate improvement in sensitivity.|Baseline, Week 8|ITT population included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.||score on a scale||Standard Deviation|Mean
636556|NCT02542943|Primary|Change From Baseline in Schiff Sensitivity Score of Experimental Oral Rinses 1 and 2 Against a Placebo Oral Rinse at Week 8|The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicate improvement in sensitivity.|Baseline, Week 8|Intent-to-treat (ITT) population included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.||score on a scale||Standard Deviation|Mean
636557|NCT02542761|Secondary|Patient Satisfaction as Measured by the Prosthesis Evaluation Questionnaire (PEQ)|The PEQ is a self-administered questionnaire composed of nine scales computed from forty-two items (ambulation, appearance, frustration, perceived response, residual limb health, social burden, sounds, utility, well being). Each question uses a visual analog scale format, scored as a continuous numerical variable measured as the distance in millimeters from the left endpoint of the measured from the left (0-100). The 0 side of the scale is very negative (terrible) and the 100 side of the scale is very positive (excellent). Each scale is reported separately, with a higher score indicating more satisfaction with the prosthesis itself or quality of life.|After approximate 4 week acclimation period|Some participants did not complete some of the scales in the questionnaire.||units on a scale||Standard Deviation|Mean
636558|NCT02542761|Secondary|Time of Peak Knee Flexion During Swing|A gait cycle is the period of time for one stride, that is, the time from one event (usually initial foot contact) to the next occurrence of the same event with the same foot. For each leg, the gait cycle can be divided into a stance phase and a swing phase. This variable is expressed as a percentage of the gait cycle.|After approximate 4 week acclimation period|||percentage of gait cycle||Standard Deviation|Mean
636559|NCT02542761|Secondary|Peak Knee Flexion During Swing|A gait cycle is the period of time for one stride, that is, the time from one event (usually initial foot contact) to the next occurrence of the same event with the same foot. For each leg, the gait cycle can be divided into a stance phase and a swing phase. This variable is measuring the angle of knee flexion during the swing phase.|After approximate 4 week acclimation period|||degrees||Standard Deviation|Mean
636560|NCT02542761|Secondary|Peak Ankle Power Generation|Joint power (P) is the “dot product” of the moment (M) at the joint and the angular velocity (w) of the distal segment with respect to the proximal segment (i.e., P = M · w). Depending on the direction of the moment and the direction of the angular velocity, the power can be positive or negative. If the signs for the moment and angular velocity are both positive or both negative, the power is positive. If the signs for the moment and angular velocity are different, the power is negative. The unit of measurement for this variable is W/kg = watts/kilogram.|After approximate 4 week acclimation period|||W/kg||Standard Deviation|Mean
636561|NCT02542761|Secondary|Peak Ankle Plantar Flexor Moment During Stance|Peak ankle plantar flexor moment means the peak force of the movement of the foot in which the foot or toes flex downward toward the sole. The unit of measurement for this variable is Nm/kg = 1 nanometer / (kilogram unit).|After approximate 4 week acclimation period|||Nm/kg||Standard Deviation|Mean
636562|NCT02542761|Primary|Peak Ankle Dorsiflexion During Stance|The peak ankle dorsiflexion is the peak ankle backward flexion or bending when walking.|After approximate 4 week acclimation period|||degrees||Standard Deviation|Mean
636563|NCT02542280|Primary|Clinical Pregnancy Rate|Ultrasound detection of an intrauterine positive fetal heart pulsations|six weeks|||participants|||Number
636564|NCT02542280|Primary|Chemical Pregnancy Rate|Human chorionic gonadotrophin (b-hcg) detection in serum two weeks after intrauterine insemination.|two weeks after intrauterine insemination|||participants|||Number
636583|NCT02541864|Primary|Number of Participants in Which H. Pylori Was Eradicated|Repeated endoscopy with rapid urease test, histological examination and culture or urea breath tests are conducted to assess H. pylori status.|at the 6th week after the end of anti- H. pylori therapy|Intention to treat||participants|||Number
636591|NCT02540772|Secondary|Number of Errors in Source Attribution|"After the recall of the material, patients were also asked to remember which modality corresponded to each recall (i.e., seen, heard or imagined), and who had presented the material during the learning session (i.e., the therapist or themselves).
Scores ranged from 0 (if all answers were non-responses) to unlimited number (depending on number of confabulations produced by patients).
The values in the table represent the mean of errors in source attribution for each group (Neuropsychological treatment or No treatment) in the 3 sessions at each baseline (pre- and post-treatment)."|Measures were recorded during 3 sessions administered in 1 week before (pre-baseline) and during 3 sessions after the treatment (post-baseline). In the control group, pre and post baselines were also recorded but without any treatment between them|Minimum number for comparison of means calculated with G*Power software (see Analysis Population Description of the first outcome measure data, i.e., confabulations).||Errors in source attribution||Standard Deviation|Mean
636592|NCT02540772|Primary|Number of Non-responses|"Scores ranged from 0 (no non-responses) to 72 (12 stimuli remembered twice in each session: firstly, in a immediate recall after learning, and secondly, in a delayed recall after 10 minutes).
The values in the table represent the mean of non-responses for each group (Neuropsychological treatment or No treatment) in the 3 sessions at each baseline (pre- and post-treatment)."|Measures were recorded during 3 sessions administered in 1 week before (pre-baseline) and during 3 sessions after the treatment (post-baseline). In the control group, pre and post baselines were also recorded but without any treatment between them|Minimum number for comparison of means calculated with G*Power software (see Analysis Population Description of the first outcome measure data, i.e., confabulations).||Non-responses||Standard Deviation|Mean
636593|NCT02540772|Primary|Number of Correct Responses|"Scores ranged from 0 (no correct answers) to 72 (12 stimuli remembered twice in each session: firstly, in a immediate recall after learning, and secondly, in a delayed recall after 10 minutes).
The values in the table represent the mean of correct responses for each group (Neuropsychological treatment or No treatment) in the 3 sessions at each baseline (pre- and post-treatment)."|Measures were recorded during 3 sessions administered in 1 week before (pre-baseline) and during 3 sessions after the treatment (post-baseline). In the control group, pre and post baselines were also recorded but without any treatment between them|Minimum number for comparison of means calculated with G*Power software (see Analysis Population Description of previous outcome measure data, i.e., confabulations).||Correct responses||Standard Deviation|Mean
636594|NCT02540772|Primary|Number of Confabulations|"The confabulations recorded were 1) guessed answers, 2) confusions in time and space, 3) a mixture of two or more stimuli presented, and 4) devised or bizarre responses.
Scores ranged from 0 (no confabulations) to unlimited number of them (because devised or bizarre responses were recorded) and consisted of the sum of all the confabulations produced during the baseline. The values in the table represent the mean of confabulations for each group (Neuropsychological treatment or No treatment) in the 3 sessions at each baseline (pre- and post-treatment)."|Measures were recorded during 3 sessions administered in 1 week before (pre-baseline) and during 3 sessions after the treatment (post-baseline). In the control group, pre and post baselines were also recorded but without any treatment between them|We used preliminary data from the first 5 patients using the G*Power software to calculate the sample size. From them, to detect differences through a Student t-test considering the significance level is 5%, the sample size was estimated in 7 subjects per group with an alpha of 0.95. We expanded to 10 to ensure greater power.||Confabulations||Standard Deviation|Mean
636595|NCT02540447|Secondary|3 Months Mortality|mortality within first 3 post-operative months|3 Months|||participants|||Number
636596|NCT02540447|Secondary|Post-operative Infectious Complications||30 days|||participants|||Number
636597|NCT02540447|Secondary|Ischemia Reperfusion Injury|incidence of ischemia reperfusion injury in the transplanted graft|7 days|||participants|||Number
636598|NCT02540447|Secondary|Biliary Complications (Participants)|Participants who developed biliary complications in three months period (Participant)|3 months|||participants|||Number
636599|NCT02540447|Primary|Lowest 5 Minutes Post-reperfusion Mean Arterial Blood Pressure|The lowest of three recorded mean arterial pressure readings at 1,3 and 5 minutes after portal declamping|5 minutes post-reperfusion|||mmHg||Standard Deviation|Mean
636600|NCT02540434|Secondary|Time to Product Administration|Time from request to administration of study product|Procedure length, the average for participants is approximately 6 hours||||||
636601|NCT02540434|Secondary|Correlation of Laboratory and ROTEM Data|Correlation of fibrinogen, von Willebrand Factor (vWF), and factor VIII levels measured in traditional lab with intraoperative ROTEM parameters|Procedure length, the average for participants is approximately 6 hours||||||
636602|NCT02540434|Secondary|Mortality Rate|Rate of hospital death during initial hospital admission.|Length of Hospital Stay, the average for participants is approximately 7 days||||||
636603|NCT02540434|Secondary|Incidence of Re-exploration|Incidence of subjects requiring a return to the OR for re-exploration.|Length of Hospital Stay, the average for participants is approximately 7 days||||||
636604|NCT02540434|Secondary|Blood Loss|Quantity of intraoperative and postoperative blood loss as recorded in the anesthesia record and in chest tube outputs (blood drainage volume)|Length of Hospital Stay, the average for participants is approximately 7 days,||||||
636605|NCT02540434|Secondary|Infection and Respiratory Failure|Incidence of any infection or respiratory failure from procedure end to hospital discharge.|Length of Hospital Stay, the average for participants is approximately 7 days||||||
636606|NCT02540434|Secondary|Thrombosis and Transfusion Reactions|Incidence of intraoperative or postoperative (during hospital admission only) thrombosis (symptomatic only) and transfusion reactions from procedure to hospital discharge.|Length of Hospital Stay, the average for participants is approximately 7 days||||||
636607|NCT02540434|Secondary|Hospital Length of Stay|Number of days subject spends in the hospital from procedure end to hospital discharge|Length of Hospital Stay, the average for participants is approximately 7 days||||||
636608|NCT02540434|Secondary|CTICU Length of Stay|Number of days subject spends in cardiothoracic intensive care unit from procedure end to hospital discharge|Length of Hospital Stay, the average for participants is approximately 7 days||||||
636609|NCT02540434|Secondary|Correction of Microvascular Bleeding|Difference in surgeon’s assessment of microvascular bleeding from approximately 15 minutes before to approximately 15 minutes after administration of study medication|~30 min intraoperatively||||||
666307|NCT01759368|Secondary|Death|Death from any cause|From baseline until the end of the study at six months|||participants|||Number
636613|NCT02540434|Primary|Intraoperative Blood Transfusion Total|The combined number of allogeneic blood products (platelets + Fresh Frozen Plasma (FFP) + RBCs) administered to subjects intraoperatively after study intervention.|Procedure length, the average for participants is approximately 6 hours|Only 1 subject out of total enrolled were randomized. This one subject was randomized to cryoprecipitate arm. Due to this only 1 subject being randomized and the study being terminated before completion, no data analysis was done to assess the primary outcome. Therefore there is no measurable data for the mean and SD in either arm.|||||
636978|NCT02515994|Secondary|Symptoms|"Ocular symptoms, problems and complaints were assessed by a questionnaire at each visit 1-, 2-, 3-, 4-, 8- and 12- week follow-ups. The number of events where subjects that responded 'yes' to the item Experienced Eye Symptoms or Problems? were reported."|Up to 3 month Follow-up|All subjects that were dispensed a study lens.||Eyes|Participants||Number
636628|NCT02540265|Secondary|Number of Subjects With Use of Rescue Medication (Oral Opioids)||48 hours|mITT analysis set||Participants|||Count of Participants
636629|NCT02540265|Secondary|Summed Pain Intensity Difference (SPID) at Other Intervals|Pain intensity was recorded using a Numeric Pain Rating Scale (Range 0-10) where 0 equates to no pain (better), and 10 equates to the worst pain imaginable (worse). Pain intensity scores were to be recorded at the following time points: 0.25, 0.5, 0.75, 1, 2, 4, and 6 hours post Dose 1. Thereafter pain assessments were to be recorded every 2 hours until 48 hours post Dose 1. Pain intensity differences from baseline at each time point were calculated and a time weighted summed pain intensity difference (SPID) was then calculated. Time weighted SPID calculations were computed by multiplying a weight factor to each score prior to summation. The weight factor at each time point was the time elapsed since the previous observation. A smaller SPID was better.|48 Hours|mITT analysis set||units on a scale||Standard Error|Least Squares Mean
636630|NCT02540265|Secondary|Summed Pain Intensity Difference Over the First 48 Hours (SPID48)|Pain intensity was recorded using a Numeric Pain Rating Scale (Range 0-10) where 0 equates to no pain (better), and 10 equates to the worst pain imaginable (worse). Pain intensity scores were to be recorded at the following time points: 0.25, 0.5, 0.75, 1, 2, 4, and 6 hours post Dose 1. Thereafter pain assessments were to be recorded every 2 hours until 48 hours post Dose 1. Pain intensity differences from baseline at each time point were calculated and a time weighted summed pain intensity difference (SPID) was then calculated. Time weighted SPID calculations were computed by multiplying a weight factor to each score prior to summation. The weight factor at each time point was the time elapsed since the previous observation. A smaller SPID was better.|48 Hours|mITT analysis set||units on a scale||Standard Error|Least Squares Mean
636631|NCT02540265|Secondary|Effect Size of N1539 Doses Using the Summed Pain Intensity Difference Over the First 48 Hours (SPID48)|Effect size was estimated based on SPID48 derived using 2-hour windowed last observation carried forward (W2LOCF) method and an analysis of covariance (ANCOVA) model that included treatment and baseline PI score.|48 Hours|All subjects treated with ≥1 dose of study medication and who had baseline PI and at least one post baseline PI (mITT analysis set; efficacy analysis set)||units on a scale||Standard Error|Least Squares Mean
636632|NCT02540265|Primary|Number of Subjects With Adverse Events|Number of subjects reporting treatment emergent adverse events|Through Day 30 Follow-up|All subjects treated with ≥1 dose of study medication (Safety analysis set)||Participants|||Count of Participants
636633|NCT02540213|Primary|Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment|Participant satisfaction with treatment was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Participant pre-post comparison of satisfaction rating was done by considering the difference of baseline rating (satisfaction rating for previous ESA) and rating at respective visit (satisfaction rating for MIRCERA). Thus, possible results were -2, -1, 0, 1, and 2, with positive values indicating a greater satisfaction with MIRCERA than with the previous ESA (acceptance and preference of MIRCERA over previous ESA). Percentage of participants with each possible result category (-2, -1, 0, 1, 2) is reported at each visit.|Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9|Participant Satisfaction Set. Here, n = participants evaluable for specified timeframe.||percentage of participants|||Number
636634|NCT02540213|Primary|Mean Monthly Administrations of MIRCERA||9 months|Efficiency Set included all participants who had at least one MIRCERA application, without any major protocol violation and had prescription and application data available for 2 months before start of MIRCERA and first 2 months of study. Here N = participants who were evaluable for this outcome measure.||MIRCERA administrations per month||Standard Deviation|Mean
636635|NCT02540213|Primary|Number of MIRCERA Dose Adaptations||9 months|Participant Satisfaction Set. Here N = participants who were evaluable for this outcome measure.||dose adaptations||Standard Deviation|Mean
636636|NCT02540213|Primary|Average Monthly Dose of MIRCERA||9 months|Participant Satisfaction Set. Here N = participants who were evaluable for this outcome measure.||grams||Standard Deviation|Mean
636637|NCT02540213|Primary|Percentage of Participants Who Continued Treatment After End of Study||End of observation period (Month 9)|Participant Satisfaction Set. Here N = participants who were evaluable for this outcome measure.||percentage of participants|||Number
636638|NCT02540213|Primary|Percentage of Participants Who Reported Easement of Therapy With MIRCERA||9 months|Participant Satisfaction Set.||percentage of participants|||Number
636639|NCT02540213|Primary|Change From Baseline in Pain Sensation Using Visual Analogue Scale|Pain sensation was reported by participants using a visual scale ranging from 0 (no pain) to 10 (strong pain). Pain sensation at baseline referred to pain sensation regarding previous ESA. Change of pain sensation = pain sensation regarding previous ESA (baseline)’ minus ‘pain sensation regarding MIRCERA (Month 1-9). Positive numbers indicate less pain sensation during MIRCERA application.|Baseline, Months 1-9|Participant Satisfaction Set. Here N = participants who were evaluable for this outcome measure and n = participants evaluable for specified timeframe.||units on a scale||Standard Deviation|Mean
636640|NCT02540213|Secondary|Change From Baseline in Hemoglobin (Hb) Concentration||Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9|Secondary endpoint set included all participants who had at least one MIRCERA application, without any major protocol violation and had at least 6 months documentation and minimum 2 of the 3 visits non-missing Hb and dosing data from Month 7 to 9 visits. N=participants evaluable for this outcome and n=participants evaluable for specified timeframe.||g/dL||Standard Deviation|Mean
637040|NCT02512393|Primary|Punctate Mechanical Pain Sensitivity|Quantitative Sensory Testing (QST) by using punctate mechanical pain delivered by a calibrated nylon monofilament.|baseline|||kilopascal (kPa)||Standard Deviation|Mean
636641|NCT02540213|Primary|Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 9|Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters.|Month 9|Participant Satisfaction Set. Here N = participants who were evaluable for this outcome measure.||percentage of participants|||Number
636642|NCT02540213|Primary|Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 8|Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters.|Month 8|Participant Satisfaction Set. Here N = participants who were evaluable for this outcome measure.||percentage of participants|||Number
636643|NCT02540213|Primary|Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 7|Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters.|Month 7|Participant Satisfaction Set. Here N = participants who were evaluable for this outcome measure.||percentage of participants|||Number
636644|NCT02540213|Primary|Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 6|Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters.|Month 6|Participant Satisfaction Set. Here N = participants who were evaluable for this outcome measure.||percentage of participants|||Number
636645|NCT02540213|Primary|Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 5|Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters.|Month 5|Participant Satisfaction Set. Here N = participants who were evaluable for this outcome measure.||percentage of participants|||Number
636646|NCT02540213|Primary|Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 4|Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters.|Month 4|Participant Satisfaction Set. Here N = participants who were available for this outcome measure.||percentage of participants|||Number
636647|NCT02540213|Primary|Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 3|Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters.|Month 3|Participant Satisfaction Set. Here N = participants who were evaluable for this outcome measure.||percentage of participants|||Number
636648|NCT02540213|Primary|Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 2|Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters.|Month 2|Participant Satisfaction Set. Here number of participants analyzed (N) = participants who were evaluable for this outcome measure.||percentage of participants|||Number
636649|NCT02540213|Primary|Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 1|Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters.|Month 1|Participant Satisfaction Set.||percentage of participants|||Number
636650|NCT02540213|Primary|Percentage of Participants Satisfied With Previous Erythropoiesis Stimulating Agent (ESA) Treatment|Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non- satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) with previous ESA treatment was reported. For participants who had multiple previous ESA treatments, the latest applied ESA before start of Mircera therapy was considered.|Baseline|Participant Satisfaction Set included all participants who had at least one MIRCERA application, without any major protocol violation and had satisfaction rating documented for previous ESA and MIRCERA.||percentage of participants|||Number
636651|NCT02539992|Secondary|Assessment of Better Performance of TKR Using a Kinematic Aligned ShapeMatch Cutting Guide by Functional Evaluation With Knee Society Score (KSS).|"The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, Range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as excellent, good, fair, or poor, a higher value represents a better outcome."|1 year follow-up|Due to early study termination, there was limited data available for analysis and therefore insufficient power to provide robust, meaningful results for our primary or secondary analysis.||units on a scale||Standard Deviation|Mean
636652|NCT02539992|Secondary|Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36).|The SF-36 Health Survey is a 36-item patient completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.|1 year follow-up|Due to early study termination, there was limited data available for analysis and therefore insufficient power to provide robust, meaningful results for our primary or secondary analysis.||units on a scale||Standard Deviation|Mean
636653|NCT02539992|Secondary|Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D).|"The EQ-5D index has an upper bound equal to 1 that indicates full health (indicated by no problem in all domains), whereas 0 represents death. Negative values are allowed, and the lower bound varies depending on country-specific value set used. UK time Trade Off (UKTTO) indicates the patient status compared to the normal state of the UK population."|1 year follow-up|Due to early study termination, there was limited data available for analysis and therefore insufficient power to provide robust, meaningful results for our primary or secondary analysis.||units on a scale||Standard Deviation|Mean
636654|NCT02539992|Secondary|Investigation of Clinical Performance and Patient Outcome With the Forgotten Joint Score (FJS) Patient Questionnaire.|The FJS consists of 12 questions and focuses on the patients’ awareness of their joint replacement during a range of day to day and recreational activities. The score has a range of 0-100. High scores indicate good outcome, i.e., a high degree of being able to forget about the affected joint in daily life.|1 year follow-up|Due to early study termination, there was limited data available for analysis and therefore insufficient power to provide robust, meaningful results for our primary or secondary analysis.||units on a scale||Standard Deviation|Mean
636655|NCT02539992|Secondary|Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire.|KOOS consists of 5 subscales: Pain, other symptoms, function in daily living , function in sport and recreation and knee related quality of life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms).|1 year follow-up|Due to early study termination, there was limited data available for analysis and therefore insufficient power to provide robust, meaningful results for our primary or secondary analysis.||units on a scale||Standard Deviation|Mean
636656|NCT02539992|Secondary|Investigation of Clinical Performance and Patient Outcome With the Get-up and go Test|"Get-up-and-go test uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.
One source suggests that scores of ten seconds or less indicate normal mobility, 11 – 20 seconds are within normal limits for frail elderly and disabled patients, and greater than 20 seconds means the person needs assistance outside and indicates further examination and intervention. A score of 30 seconds or more suggests that the person may be prone to falls."|1 year|Due to early study termination, there was limited data available for analysis and therefore insufficient power to provide robust, meaningful results for our primary or secondary analysis.||seconds||Standard Deviation|Mean
636657|NCT02539992|Primary|Assessment of Better Functional Performance of Total Knee Replacement (TKR) Using a Kinematic Aligned ShapeMatch Cutting Guide by Means of Fluoroscopy.|To demonstrate by means of fluoroscopy that TKR's performed using a kinematic aligned ShapeMatch Cutting Guide provides better short term kinematic and functional performance compared to those TKR's performed with ShapeMatch cutting guides modified to provide neutral overall limb alignment or with conventional instrumentation intended to achieve neutral overall limb alignment.|6 months|Early study termination resulted in limited availability of data for analysis to provide robust, meaningful results. Therefore the fluoroscopic data sets of the Neutral Overall Limb Alignment and Conventional Limb Alignment groups were combined and compared with the Kinematic Alignment group.||Degrees||Standard Deviation|Mean
636658|NCT02539134|Secondary|AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to Over the Dosing Interval for TAK-935||Day 14: Pre-dose and at multiple time points (up to 24 hours for Cohorts 1, 2, 4, and 5; up to 12 hours for Cohort 3) post-dose|The PK set included all participants in the safety set who had at least 1 measurable plasma or urine concentration. No data was reported for Cohorts 3 and 4 since dosing was discontinued after Day 10.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
636659|NCT02539134|Secondary|AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-935||Day 1: Pre-dose and at multiple time points (up to 24 hours for Cohorts 1, 2, 4, and 5; up to 12 hours for Cohort 3) post-dose|The PK set where Day 1 assessment for AUC∞ was available. The PK set included all participants in the safety set who had at least 1 measurable plasma or urine concentration.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
636660|NCT02539134|Secondary|AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-935||Day 1 and Day 14: Pre-dose and at multiple time points (up to 24 hours for Cohorts 1, 2, 4, and 5; up to 12 hours for Cohort 3) post-dose|The PK set included all participants in the safety set who had at least 1 measurable plasma or urine concentration.||nanogram*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
636661|NCT02539134|Secondary|Cmax: Maximum Observed Plasma Concentration for TAK-935||Day 1 and Day 14: Pre-dose and at multiple time points (up to 24 hours for Cohorts 1, 2, 4, and 5; up to 12 hours for Cohort 3) post-dose|The pharmacokinetic (PK) set included all participants in the safety set who had at least 1 measurable plasma or urine concentration.||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
636662|NCT02539134|Primary|Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Safety 12-lead Electrocardiogram (ECG) Parameters at Least Once Post Dose||Baseline up to Day 15|The safety analysis set included all participants who were enrolled and received study drug.||percentage of participants|||Number
636663|NCT02539134|Primary|Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose||Baseline up to Day 15|The safety analysis set included all participants who were enrolled and received study drug.||percentage of participants|||Number
636664|NCT02539134|Primary|Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose||Baseline up to Day 15|The safety analysis set included all participants who were enrolled and received study drug.||percentage of participants|||Number
636665|NCT02539134|Primary|Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE)||Day 1 up to Day 28|The safety analysis set included all participants who were enrolled and received study drug.||percentage of participants|||Number
636666|NCT02539108|Secondary|Geometric Mean Titer Ratios of Influenza Virus Antibodies Following Vaccination With the 2015-2016 Formulation of Fluzone® Quadrivalent Influenza Vaccine|Anti-influenza antibodies were measured using an hemagglutination inhibition assay. Geometric mean of titer ratio is the geometric mean of the individual post-vaccination/pre-vaccination titer ratios|Day 0 (pre-vaccination) and 28 days post-last vaccination|Anti-influenza antibody titers were assessed in the Per-protocol Analysis Set.||Titer ratio||95% Confidence Interval|Geometric Mean
636667|NCT02539108|Secondary|Number of Participants Who Achieved Seroconversion Following Vaccination With the 2015-2016 Formulation of Fluzone® Quadrivalent Influenza Vaccine|Anti-influenza antibodies were measured using an hemagglutination inhibition (HAI) assay. Seroconversion was defined as either a pre-vaccination HAI titer < 1:10 and a post-final vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-final vaccination titer.|28 days post-last vaccination|Anti-influenza antibody titers were assessed in the Per-Protocol Analysis Set.||Participants|||Number
636668|NCT02539108|Secondary|Number of Participants Who Achieved Seroprotection to Influenza Virus Antigens Pre- and Post-Vaccination With the 2015-2016 Formulation of Fluzone® Quadrivalent Influenza Vaccine|Anti-influenza antibodies were measured using an hemagglutination inhibition assay. Seroprotection was defined as a pre-vaccination or post-vaccination influenza antibody titer of ≥ 1:40 (1/dilutions).|Day 0 (pre-vaccination) and 28 days post-last vaccination|Anti-influenza antibody titers were assessed in the Per-Protocol Analysis Set.||Participants|||Number
636669|NCT02539108|Secondary|Geometric Mean Titers of Influenza Virus Antibodies Following Vaccination With the 2015-2016 Formulation of Fluzone® Quadrivalent Influenza Vaccine|Anti-influenza antibodies were measured using an hemagglutination inhibition assay.|Day 0 (pre-vaccination) and 28 days post-last vaccination|Anti-influenza antibody titers were assessed in the Per-protocol Analysis Set.||Titers (1/dilutions)||95% Confidence Interval|Geometric Mean
636670|NCT02539108|Primary|Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2015-2016 Formulation of Fluzone® Quadrivalent Influenza Vaccine.|"Solicited injection-site reactions for 6 to < 36 months: Tenderness, Erythema, and Swelling. For 3 to < 9 years: Pain, Erythema, and Swelling. Solicited systemic reactions for 6 to < 36 months: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability. For 3 to < 9 years: Fever (Temperature), Headache, Malaise, and Myalgia.
Grade 3 for 6 to < 36 months: Tenderness, Cries when injected limb is moved; Erythema and Swelling, ≥ 50 mm; Vomiting, 6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, > 3 hours; Drowsiness, sleeping most of the time or difficult to wake up; Appetite lost, Refuses ≥ 3 feeds/meals or refuses most feeds/meals; and Irritability, Inconsolable.
Grade 3 for 3 to < 9 years: Pain, Incapacitating; Erythema and Swelling, ≥ 50 mm; Fever, ≥ 39.0°C; Headache, Malaise, and Myalgia, prevents daily activity."|Day 0 up to Day 7 post any vaccination|Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set.||Participants|||Number
636671|NCT02537522|Primary|Correlation Between Subjective CLUE Comfort and Corneal Diameter|Assessment The Contact Lens User Evaluation (CLUE)™ questionnaire is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20) with a range of 0-120, where higher scores indicate a more favorable/positive response (Wirth, RJ Et al. August 2016). Corneal diameter (horizontal visible iris diameter [HVID]) was collected at baseline for both eyes using a slit lamp reticle, measuring to the nearest 0.05 mm.The maximum (or minimum) measurements of HVID between the two eyes of each subject were used for correlation analyses between subjective CLUE comfort score and corneal diameter.|3-day follow-up|Subjects that completed all study visits without a major protocol deviation.||Pearson Correlation|||Number
636672|NCT02537522|Primary|Correlation Between Subjective CLUE Comfort and Keratometry|CLUE- The Contact Lens User Evaluation (CLUE)™ questionnaire is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20) with a range of 0-120, where higher scores indicate a more favorable/positive response (Wirth, RJ. Et al. August 2016). Keratometry measurements of major keratometric meridians (diopter [DK]) and their location (degrees) was collected at baseline for both eyes. The correlation between CLUE comfort and maximum Keratometry measurements of the two eyes within each subject and the correlation between CLUE comfort and the minimum Keratometry measurements of the two eyes within each subject were reported.|3-day follow-up|Subjects that completed all study visits without a major protocol deviation.||Pearson Correlation|||Number
636673|NCT02538107|Primary|Average Duration in Months Mircera Was Administered at Current Dose After the Previous Dose Adjustment||Up to 50 months|Efficacy analysis set. Participants with non-missing values were included.||months||Standard Deviation|Mean
636674|NCT02538107|Primary|Percentage of Participants With a Hemoglobin Value of 10-13 g/dL From Visit 7 (Month 7) to Visit 15 (Month 15)||From Month 7 to Month 15|Efficacy analysis set. Participants who were evaluable at the specified time frame were included.||percentage of participants|||Number
636675|NCT02538107|Secondary|Hemoglobin Level Based on the Glomerular Filtration Rate (GFR)|GFR is described as the flow rate of filtered fluid through the kidney and was determined using the Cockcroft-Gault formula to calculate the creatinine clearance. For males, creatinine clearance [milliliters per minute (mL/min)] = [(140 minus age) multiplied by (*) (body weight in kilogram [kg]) divided by [72 * serum creatinine milligrams per deciliter (mg/dL)]. For females, creatinine clearance (mL/min) = 0.85 * [(140 minus age) * (body weight in kg)] divided by [72 * serum creatinine (mg/dL)]. Participants were classified based on the GFR in to two groups; GFR less than (<) 30 mL/min and in the range of 30-60 mL/min and hemoglobin levels at different visits were presented.|Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15 and Entire study (Month 1 to Month 15)|Efficacy analysis set. Participants who were evaluable for the specified group were included and n = number of participants who were evaluable at a particular visit.||g/dL||Standard Deviation|Mean
636676|NCT02538107|Secondary|Hemoglobin Level Based on the Acute Bleeding Episode(s) During the Study|Participants were classified in to two groups based on the presence of acute bleeding episodes during the study; presence or absence of bleeding episodes.|Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15 and Entire study (Month 1 to Month 15)|Efficacy analysis set. Participants who were evaluable for the specified group were included and n = number of participants who were evaluable at a particular visit.||g/dL||Standard Deviation|Mean
636677|NCT02538107|Secondary|Hemoglobin Level Based on the Etiology of Chronic Kidney Disease|Participants were classified based on the etiology of chronic kidney disease. The different etiological reasons included diabetic vasculopathy, hypertensive nephrosclerosis, glomerulonephritis, polycystic kidney, chronic pyelonephritis, other reasons and origin unknown. Hemoglobin levels in participants who had etiology of chronic kidney disease as 'glomerulonephritis' or 'other reasons' were presented as these were the majority of the etiological reasons for chronic kidney disease.|Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15 and Entire study (Month 1 to Month 15)|Efficacy analysis set. Participants who were evaluable for the specified group were included and n = number of participants who were evaluable at a particular visit.||g/dL||Standard Deviation|Mean
636678|NCT02538107|Secondary|Hemoglobin Level Based on the Presence of Inflammatory Diseases|Participants were classified based on the presence of other inflammatory diseases at baseline in to two groups; participants with presence of inflammatory diseases and participants with absence of inflammatory diseases.|Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15 and Entire study (Month 1 to Month 15)|Efficacy analysis set. n = number of participants who were evaluable at a particular visit.||g/dL||Standard Deviation|Mean
636679|NCT02538107|Secondary|Hemoglobin Level Based on the Type of Kidney Transplantation Performed|Participants were classified based on the type of kidney transplantation they underwent before entering in to the study in to two groups; participants who received living donation and participants who received cadaveric donation.|Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15 and Entire study (Month 1 to Month 15)|Efficacy analysis set. n = number of participants who were evaluable at a particular visit.||g/dL||Standard Deviation|Mean
636680|NCT02538107|Primary|Percentage of Participants With a Hemoglobin Value of 10-13 g/dL From Visit 7 (Month 7) to Visit 12 (Month 12)||From Month 7 to Month 12|Efficacy analysis set. Participants who were evaluable at the specified time frame were included.||percentage of participants|||Number
636681|NCT02538107|Primary|Percentage of Participants With a Hemoglobin Value of 11-13 g/dL From Visit 7 (Month 7) to Visit 15 (Month 15)||From Month 7 to Month 15|Efficacy analysis set. Participants who were evaluable at the specified time frame were included.||percentage of participants|||Number
636682|NCT02538107|Primary|Percentage of Participants With a Hemoglobin Value of 11-13 g/dL From Visit 7 (Month 7) to Visit 12 (Month 12)||From Month 7 to Month 12|Efficacy analysis set. Participants who were evaluable at the specified time frame were included.||percentage of participants|||Number
636683|NCT02538107|Primary|Percentage of Participants With a Hemoglobin Value of 11-13 g/dL From Visit 7 (Month 7) to Visit 9 (Month 9)||From Month 7 to Month 9|Efficacy analysis set.||percentage of participants|||Number
636684|NCT02538107|Primary|Percentage of Participants With a Hemoglobin Value of 11-12 Grams Per Deciliter (g/dL) From Visit 7 (Month 7) to Visit 9 (Month 9)||From Month 7 to Month 9|Efficacy analysis set (Included participants who reported no pregnancy during the study period and had dosing and hemoglobin data available during 1 of the 3 visits [Visits 7-9]).||percentage of participants|||Number
636685|NCT02537730|Secondary|Stinging and Burning Sensation|Subjective ratings of stinging and burning sensation for Bioclean MPS VII / comfilcon A combination and Aosept Clearcare / comfilcon A combination. Scale 0-10, 0=difficult to wear, 10=no sensation at all.|Baseline|||units on a scale||Standard Deviation|Mean
636686|NCT02537730|Secondary|Dryness|Subjective ratings of dryness for Bioclean MPS VII / comfilcon A combination and Aosept Clearcare / comfilcon A combination were assessed at 1 week: after insertion, after 4 hours of wear, after 8 hours of wear, before removal, and after all day wear. Scale 0-10, 0=very bad/poor, 10=very good/excellent.|1 week|||units on a scale||Standard Deviation|Mean
636687|NCT02537730|Secondary|Comfort|Subjective ratings of comfort scores for Bioclean MPS VII / comfilcon A combination and Aosept Clearcare / comfilcon A combination were assessed at 1 week: after insertion, after 4 hours of wear, after 8 hours of wear, before removal, and after all day wear. Scale 0-10, 0=very bad/poor, 10=very good/excellent.|1 week|||units on a scale||Standard Deviation|Mean
636688|NCT02537730|Primary|Ocular Health - Corneal Staining|Corneal staining for Bioclean MPS (Multi-Purpose Solution) VII / comfilcon A combination and Aosept Clearcare / comfilcon A combination assessed by slit lamp. Grade 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe.|1 week|||Eyes|Participants||Number
636689|NCT02536781|Secondary|VAS Scores Range From 0 (no Pain) to 10 (Severe Pain)||Days 0 and 7 after treatment|||units on a scale||Standard Deviation|Mean
636690|NCT02536781|Primary|Wound Size (mm^2) Reduction|Comparing between the active and placebo about the wound size reduction from day 0 to day 7 after treatment|Days 0 and 7 after treatment|||mm^2||Standard Deviation|Mean
636691|NCT02536664|Secondary|Percentage of Participants With Initiation of New Therapy|Percentage of participants for whom new therapy was initiated at the end of maintenance therapy was reported.|2 years|Included participants who were considered for the efficacy analysis after 2 years of Rituximab maintenance therapy.||percentage of participants|||Number
636692|NCT02536664|Secondary|Percentage of Participants With Best Overall Response|The percentage of participants was presented with respect to the best overall response (CR, PR, SD). CR is defined as the disappearance of all target and non-target lesions and normalization of tumor marker level; PR is defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter; SD for target lesions is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started and SD for non-target lesions defined as persistence of 1 or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.|2 years|Included participants who were considered for the efficacy analysis after 2 years of Rituximab maintenance therapy.||percentage of participants||95% Confidence Interval|Number
636693|NCT02536664|Secondary|Percentage of Participants With Response (Complete Response [CR], Partial Response [PR], Stable Disease [SD] or Progressive Disease [PD] at the End of Maintenance Therapy|CR is defined as the disappearance of all target and non-target lesions and normalization of tumor marker level; PR is defined as at least a 30 percentage (%) decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter; SD for target lesions is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started and SD for non-target lesions defined as persistence of 1 or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. PD is defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and non-target lesions) or the unequivocal progression of existing non-target lesions.|2 years|Included participants who were considered for the efficacy analysis after 2 years of Rituximab maintenance therapy.||percentage of participants|||Number
637041|NCT02512393|Primary|Pressure Pain Threshold|Quantitative Sensory Testing (QST) by using pressure pain delivered by a hand-held algometer.|day 5|||kilopascal (kPa)||Standard Deviation|Mean
666638|NCT01754194|Secondary|Health Resource Utilization - Recovery Time From Surgery||12 months|||Days||Standard Deviation|Mean
636694|NCT02536664|Secondary|Median Overall Survival (OS) Time|Survival was the interval of time from date of first dose of study medication to date of death at any time. Participants who had not died were censored at the date of last contact when they were known to be alive. OS was assessed using Kaplan-Meier estimate.|2 years|Included participants who were considered for the efficacy analysis after 2 years of Rituximab maintenance therapy.||months||95% Confidence Interval|Median
636695|NCT02536664|Secondary|Percentage of Participants Who Were Alive|Death for any reason was regarded as an event. Percentage of participants who were alive after 2 years of maintenance therapy with Rituximab was reported.|2 years|Included participants who were considered for the efficacy analysis after 2 years of Rituximab maintenance therapy.||percentage of participants||95% Confidence Interval|Number
636696|NCT02536664|Secondary|Median Progression Free Survival (PFS) Time|PFS was defined as the time from the date of the first cycle to the first occurrence of progression of tumor or death from any reason (whichever occurred first). If progression or death was not observed during the study, progression-free survival time was censored by the last documented tumor assessment during the maintenance therapy (latest at the end of study after two years). Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and non-target lesions) or the unequivocal progression of existing non-target lesions. PFS was assessed using Kaplan-Meier estimate.|2 years|Included participants who were considered for the efficacy analysis after 2 years of Rituximab maintenance therapy.||months||95% Confidence Interval|Median
636697|NCT02536664|Primary|Percentage of Participants Who Were Alive and Free From Progressive Disease|Progressive Disease is defined as at least a 20 percent (%) increase in the sum of the longest diameter of target lesions, taking) as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and non-target lesions) or the unequivocal progression of existing non-target lesions.|2 years|Included participants who were considered for the efficacy analysis after 2 years of Rituximab maintenance therapy.||percentage of participants||95% Confidence Interval|Number
636698|NCT02536313|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure is defined as:
On-treatment virologic failure:
Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)
Virologic relapse:
Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 24|Full Analysis Set||percentage of participants|||Number
636699|NCT02536313|Secondary|HCV RNA Change From Baseline/Day 1 Through Week 12||Weeks 1, 2, 4, 8, and 12|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
636700|NCT02536313|Secondary|Percentage of Participants With HCV RNA < LLOQ on Treatment||Weeks 1, 2, 4, 8 and 12|Full Analysis Set||percentage of participants||95% Confidence Interval|Number
636701|NCT02536313|Secondary|Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR 24 are defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set||percentage of participants||95% Confidence Interval|Number
636702|NCT02536313|Primary|Percentage of Participants Who Permanently Discontinued SOF/VEL/VOX Due to an Adverse Event||Up to 12 weeks|Safety Analysis Set: participants who took at least 1 dose of study drug||percentage of participants|||Number
636703|NCT02536313|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Cessation of Treatment (SVR12)|SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: all randomized/enrolled participants who took at least 1 dose of study drug.||percentage of particpants||95% Confidence Interval|Number
636704|NCT02535741|Secondary|Investigation of Clinical Performance and Patient Outcome With the Western Ontario McMaster Osteoarthritis Index (WOMAC) Patient Questionnaire|The WOMAC collects information specific to osteoarthritis outcomes. The questionnaire uses a visual analog scale for pain, measuring factors of general pain, stiffness, and physical findings. Pain is scored from 0 to 100 for each set of factors, with 0 indicating no pain and 100 indicating extreme pain. Total WOMAC scores range from 0 to 300. Lower values represent better outcomes.|Pre-operative, 3 months, 1, 2, 3, 4 and 5 years follow-up||||||
636705|NCT02535741|Secondary|Investigation of Clinical Performance and Patient Outcome With the Short Form 12 (SF-12) Patient Questionnaire|The SF-12 Health Survey is a 12-item patient completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.|Pre-operative, 3 months, 1, 2, 3, 4 and 5 years follow-up||||||
636706|NCT02535741|Secondary|Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS)|"The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, Range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as excellent, good, fair, or poor, a higher value represents a better outcome."|Pre-operative, 3 months, 1, 2, 3, 4 and 5 years follow-up||||||
636707|NCT02535741|Secondary|Investigation of Patient Outcome With Radiographic Analysis|Plain radiographs will be obtained for assessment of fixation of the device.|Pre-operative, 3 months, 1, 2 and 5 years follow-up||||||
636708|NCT02535741|Primary|Comparison of the Active Range of Motion (ROM) Values Between Triathlon CR and Active ROM Values of Scorpio CR From the Literature|Comparison of the active ROM values for patients receiving the Triathlon CR Total Knee System with historical active ROM values of the Scorpio CR Total Knee System, a control group by literature review at 2 years post Total Knee Arthroplasty. See Chaudhary R, et al 2008 JBJS included for historical control data.|2 years follow-up|134 cases at 2 years follow-up of the Triathlon CR study have been compared to 40 cases from a historical Scorpio CR study.||degree||Standard Deviation|Mean
637042|NCT02512393|Primary|Pressure Pain Threshold|Quantitative Sensory Testing (QST) by using pressure pain delivered by a hand-held algometer.|baseline|||kilopascal (kPa)||Standard Deviation|Mean
637043|NCT02512393|Primary|Heat Pain Tolerance|Quantitative Sensory Testing (QST) by using heat pain delivered by using thermal probe on the skin.|day 5|||Celsius||Standard Deviation|Mean
636709|NCT02535026|Primary|Percentage of Participants With Breast Cancer Phenotypes Among Different Hispanic Countries|Breast cancer phenotypes were classified in to a) Luminal A: tissue samples that were ER+ and/or PR+, HER2-, and either histologic grade 1 or 2; b) Luminal B: tissue samples that were ER+ and/or PR+ and HER2+ or ER+ and/or PR+ and HER2- and histologic grade 3; c) HER2 enriched: tissue samples that were ER-, PR-, and HER2+; d) Triple negative: tissue samples that were negative for ER, PR, and HER2.|Baseline up to 30 months|Included all breast cancer tissue samples for which the phenotype was identified.||percentage of participants|Number of Tissue samples||Number
636710|NCT02535026|Primary|Percentage of Participants With Different Phenotypes of Breast Cancer Based on HER2 Status|Breast cancer phenotypes were classified in to a) Luminal A: tissue samples that were ER+ and/or PR+, HER2-, and either histologic grade 1 or 2; b) Luminal B: tissue samples that were ER+ and/or PR+ and HER2+ or ER+ and/or PR+ and HER2- and histologic grade 3; c) HER2 enriched: tissue samples that were ER-, PR-, and HER2+; d) Triple negative: tissue samples that were negative for ER, PR, and HER2.|Baseline up to 30 months|Included all breast cancer tissue samples for which the phenotype was identified.||percentage of participants|Tissue samples||Number
636711|NCT02535026|Primary|Percentage of Participants With Different Phenotypes of Breast Cancer Based on PR Status|Breast cancer phenotypes were classified in to a) Luminal A: tissue samples that were ER+ and/or PR+, HER2-, and either histologic grade 1 or 2; b) Luminal B: tissue samples that were ER+ and/or PR+ and HER2+ or ER+ and/or PR+ and HER2- and histologic grade 3; c) HER2 enriched: tissue samples that were ER-, PR-, and HER2+; d) Triple negative: tissue samples that were negative for ER, PR, and HER2.|Baseline up to 30 months|Included all breast cancer tissue samples for which the phenotype was identified.||percentage of participants|Tissue samples||Number
636712|NCT02535026|Primary|Percentage of Participants With Different Phenotypes of Breast Cancer Based on ER Status|Breast cancer phenotypes were classified in to a) Luminal A: tissue samples that were ER+ and/or PR+, HER2-, and either histologic grade 1 or 2; b) Luminal B: tissue samples that were ER+ and/or PR+ and HER2+ or ER+ and/or PR+ and HER2- and histologic grade 3; c) HER2 enriched: tissue samples that were ER-, PR-, and HER2+; d) Triple negative: tissue samples that were negative for ER, PR, and HER2.|Baseline up to 30 months|Included all breast cancer tissue samples for which the phenotype was identified.||percentage of participants|Tissue samples||Number
636713|NCT02535026|Primary|Percentage of Participants With Different Phenotypes of Breast Cancer Based on Lymphovascular Invasion|Breast cancer phenotypes were classified in to a) Luminal A: tissue samples that were ER+ and/or PR+, HER2-, and either histologic grade 1 or 2; b) Luminal B: tissue samples that were ER+ and/or PR+ and HER2+ or ER+ and/or PR+ and HER2- and histologic grade 3; c) HER2 enriched: tissue samples that were ER-, PR-, and HER2+; d) Triple negative: tissue samples that were negative for ER, PR, and HER2. Lymphovascular invasion is entering of breast cancer cells in to the lymph or vascular/blood channels.|Baseline up to 30 months|Included breast cancer tissue samples of all participants who were evaluable for this outcome measure.||percentage of participants|Tissue samples||Number
636714|NCT02535026|Primary|Percentage of Participants With Different Phenotypes of Breast Cancer Based on Nuclear Grades|Breast cancer phenotypes were classified in to a) Luminal A: tissue samples that were ER+ and/or PR+, HER2-, and either histologic grade 1 or 2; b) Luminal B: tissue samples that were ER+ and/or PR+ and HER2+ or ER+ and/or PR+ and HER2- and histologic grade 3; c) HER2 enriched: tissue samples that were ER-, PR-, and HER2+; d) Triple negative: tissue samples that were negative for ER, PR, and HER2. Nuclear pleomorphism was observed and graded accordingly. Grade 1: Nuclei small with little increase in size in comparison with normal breast epithelial cells, regular outlines, uniform nuclear chromatin, little variation in size; Grade 2: Cells larger than normal with open vesicular nuclei, visible nucleoli, and moderate variability in both size and shape; Grade 3: Vesicular nuclei, often with prominent nucleoli, exhibiting marked variation in size and shape, occasionally with very large and bizarre forms.|Baseline up to 30 months|Included all breast cancer tissue samples for which the phenotype was identified.||percentage of participants|Tissue samples||Number
636715|NCT02535026|Primary|Percentage of Participants With Different Phenotypes of Breast Cancer Across Different Age Groups|Breast cancer phenotypes were classified in to a) Luminal A: tissue samples that were ER+ and/or PR+, HER2-, and either histologic grade 1 or 2; b) Luminal B: tissue samples that were ER+ and/or PR+ and HER2+ or ER+ and/or PR+ and HER2- and histologic grade 3; c) HER2 enriched: tissue samples that were ER-, PR-, and HER2+; d) Triple negative: tissue samples that were negative for ER, PR, and HER2. Participants were categorized in to following age groups: a) <40 years, b) 40-49 years, c) 50-59 years, d) 60-69 years, e) ≥70 years.|Baseline up to 30 months|Included all breast cancer tissue samples for which the phenotype was identified.||percentage of participants|Tissue samples||Number
636716|NCT02535026|Primary|Percentage of Participants With HER2 Status (Positive or Negative) Based on Lymphovascular Invasion|Lymphovascular invasion is entering of breast cancer cells in to the lymph or blood/vascular channels.|Baseline up to 30 months|Included breast cancer tissue samples of all participants who were evaluable for this outcome measure.||percentage of participants|Tissue samples||Number
636717|NCT02535026|Primary|Percentage of Participants With HER2 Status (Positive or Negative) Based on Nuclear Grades|Nuclear pleomorphism was observed and graded accordingly. Grade 1: Nuclei small with little increase in size in comparison with normal breast epithelial cells, regular outlines, uniform nuclear chromatin, little variation in size; Grade 2: Cells larger than normal with open vesicular nuclei, visible nucleoli, and moderate variability in both size and shape; Grade 3: Vesicular nuclei, often with prominent nucleoli, exhibiting marked variation in size and shape, occasionally with very large and bizarre forms.|Baseline up to 30 months|Included breast cancer tissue samples of all participants who were evaluable for this outcome measure.||percentage of participants|Tissue samples||Number
636718|NCT02535026|Primary|Percentage of Participants With HER2 Status (Positive or Negative) Across Different Age Groups|Participants were categorized in to following age groups: a) <40 years, b) 40-49 years, c) 50-59 years, d) 60-69 years, e) ≥70 years.|Baseline up to 30 months|Included breast cancer tissue samples of all participants who were evaluable for this outcome measure.||percentage of participants|Tissue samples||Number
636719|NCT02535026|Primary|Percentage of Participants With PR Status (Positive or Negative) Based on Lymphovascular Invasion|Lymphovascular invasion is entering of breast cancer cells in to the lymph or vascular/blood channels.|Baseline up to 30 months|Included breast cancer tissue samples of all participants who were evaluable for this outcome measure.||percentage of participants|Tissue samples||Number
637788|NCT02471612|Secondary|Need for Postoperative Ventilator Support|Number of patients needing post-operative ventilatory support|30 days|||participants|||Number
636720|NCT02535026|Primary|Percentage of Participants With PR Status (Positive or Negative) Based on Nuclear Grades|Nuclear pleomorphism was observed and graded accordingly. Grade 1: Nuclei small with little increase in size in comparison with normal breast epithelial cells, regular outlines, uniform nuclear chromatin, little variation in size; Grade 2: Cells larger than normal with open vesicular nuclei, visible nucleoli, and moderate variability in both size and shape; Grade 3: Vesicular nuclei, often with prominent nucleoli, exhibiting marked variation in size and shape, occasionally with very large and bizarre forms.|Baseline up to 30 months|Included breast cancer tissue samples from all participants who were willing to participate in the study.||percentage of participants|Tissue samples||Number
636721|NCT02535026|Primary|Percentage of Participants With PR Status (Positive or Negative) Across Different Age Groups|Participants were categorized in to following age groups: a) <40 years, b) 40-49 years, c) 50-59 years, d) 60-69 years, e) ≥70 years.|Baseline up to 30 months|Included breast cancer tissue samples from all participants who were willing to participate in the study.||percentage of participants|Tissue samples||Number
636722|NCT02535026|Primary|Percentage of Participants With ER Status (Positive or Negative) Based on Lymphovascular Invasion|Lymphovascular invasion is entering of breast cancer cells in to the lymph or vascular/blood channels.|Baseline up to 30 months|Included breast cancer tissue samples of all participants who were evaluable for this outcome measure.||percentage of participants|Tissue samples||Number
636723|NCT02535026|Primary|Percentage of Participants With ER Status (Positive or Negative) Based on Nuclear Grades|Nuclear pleomorphism was observed and graded accordingly. Grade 1: Nuclei small with little increase in size in comparison with normal breast epithelial cells, regular outlines, uniform nuclear chromatin, little variation in size; Grade 2: Cells larger than normal with open vesicular nuclei, visible nucleoli, and moderate variability in both size and shape; Grade 3: Vesicular nuclei, often with prominent nucleoli, exhibiting marked variation in size and shape, occasionally with very large and bizarre forms.|Baseline up to 30 months|Included breast cancer tissue samples from all participants who were willing to participate in the study.||percentage of participants|Tissue samples||Number
636724|NCT02535026|Primary|Percentage of Participants With ER Status (Positive or Negative) Across Different Age Groups|Participants were categorized in to following age groups: a) less than (<) 40 years, b) 40-49 years, c) 50-59 years, d) 60-69 years, e) greater than or equal to (≥) 70 years.|Baseline up to 30 months|Included breast cancer tissue samples from all participants who were willing to participate in the study.||percentage of participants|Tissue samples||Number
636725|NCT02535026|Primary|Percentage of Participants With Histological Sub-types of Breast Cancer|Histological subtypes of breast cancer included ductal carcinoma, lobular carcinoma, mucinous carcinoma, mixed carcinoma, metaplastic carcinoma, and others.|Baseline up to 30 months|Included breast cancer tissue samples from all participants who were willing to participate in the study.||percentage of participants|Tissue samples||Number
636726|NCT02535026|Primary|Percentage of Participants With Different Phenotypes of Breast Cancer|Breast cancer phenotypes were classified in to a) Luminal A: tissue samples that were estrogen receptor (ER) + and/or progesterone receptor (PR) +, HER2-, and either histologic grade 1 or 2; b) Luminal B: tissue samples that were ER+ and/or PR+ and HER2+ or ER+ and/or PR+ and HER2- and histologic grade 3; c) HER2 enriched: tissue samples that were ER-, PR-, and HER2+; d) Triple negative: tissue samples that were negative for ER, PR, and HER2. Histological grading was done by Nottingham Histologic Score system based on three factors, a) the amount of gland formation (differentiation), b) the nuclear features (pleomorphism) and c) the mitotic activity. Each of these features is scored from 1-3, and then each score is added to give a final total score ranging from 3-9. The final total score is used to determine the grade in the following way: i) Grade 1 tumors have a score of 3-5, ii) Grade 2 tumors have a score of 6-7, and iii) Grade 3 tumors have a score of 8-9.|Baseline up to 30 months|Included all breast cancer tissue samples for which the phenotype could be identified.||percentage of participants|Tissue samples||Number
636727|NCT02535026|Primary|Percentage of Participants With Human Epidermal Growth Factor Receptor 2 (HER2) Status in Breast Cancer Specimens Using Immunohistochemistry (IHC) and Silver In-Situ Hybridization (SISH) Procedures|"HER2 status of the collected tissue samples was determined based on the results obtained from IHC test and SISH procedure. The IHC test gives a score of 0 to 3 positive (+) that measures the amount of HER2 receptor protein on the surface of cells in a breast cancer tissue sample. If the score is 0 to 1+, it’s called “HER2 negative (-).” If the score is 2+, it's called borderline. A score of 3+ is called “HER2 positive.” Tissue samples which had the IHC score of 2+ (borderline) were re-tested using SISH procedure for confirmation of the HER2 status. Tissue samples with SISH test results + were considered as HER2+. Tissue samples for which HER2 status was not determined were considered as HER2 equivocal."|Baseline up to 30 months|Included breast cancer tissue samples from all participants who were willing to participate in the study.||percentage of participants|Tissue samples||Number
636728|NCT02534324|Secondary|Systolic Blood Pressure at Follow-up|Systolic blood pressure at follow-up measured by physicians that were non-investigators and unaware of the study.|3 to 7 days|||mmHg||Standard Deviation|Mean
636729|NCT02534324|Secondary|Number of Participants Who Had Major Hypertensive-related Events After Discharge From the Emergency Department|Participants who had major hypertensive-related events defined by those who had one or more of the followings: acute chest pain, heart failure, acute coronary syndromes, acute aortic syndromes, retinal/vitreous hemorrhage, hypertensive retinopathy, seizure, acute cerebrovascular diseases, hypertensive encephalopathy, which occurred within 7 days after discharge from emergency department.|7 days|||participants|||Number
636730|NCT02534324|Primary|Number of Participants Who Died Within 7 Days After Discharge From the Emergency Department|Number of participants who died from hypertension-related events within 7 days after discharge from the emergency department.|7 days|||participants|||Number
636731|NCT02534129|Primary|Radiation Dermatitis as Determined by Radiation Therapy Oncology Group (RTOG) Acute Radiation Morbidity Scoring Criteria|A blinded observer will quantify degree of dermatitis assigning each half of the radiation field a score from 0 to 4. 0 represents no dermatitis and 4 is severe dermatitis using the RTOG scoring criteria.|8 weeks|All patients were analyzed by blinded observor||units on a scale||Full Range|Median
637044|NCT02512393|Primary|Heat Pain Tolerance|Quantitative Sensory Testing (QST) by using heat pain delivered by using thermal probe on the skin.|baseline|||Celsius||Standard Deviation|Mean
637045|NCT02512393|Primary|Heat Pain Threshold|Quantitative Sensory Testing (QST) by using heat pain delivered by using thermal probe on the skin.|day 5|||Celsius||Standard Deviation|Mean
636732|NCT02533466|Secondary|Change From Baseline in Buffering Capacity 7 Hours Post Dietary Acid Challenge|Saliva was collected and stored at 0 - 20°C. A Saliva-check Buffer Kit was used to determine the buffer capacity. The colourimetric assay yielded a coloured pattern on a paper diagnostic using a 0-12 scale where 0-5 was deemed to be very low, 6-9 was deemed low and 10-12 was deemed normal-high.|Baseline, 7 hours post dietary acid challenge|The PP population was defined as those subjects in the ITT population who have at least one assessment of efficacy considered unaffected by protocol violation. Assessments of efficacy considered affected by protocol violation was excluded from PP analyses. The primary population was the PP population.||scores on a scale||Standard Deviation|Mean
636733|NCT02533466|Secondary|Change From Baseline in Buffering Capacity at 30 Mins Post Dietary Acid Challenge|Saliva was collected and stored at 0 - 20°C. A Saliva-check Buffer Kit was used to determine the buffer capacity. The colourimetric assay yielded a coloured pattern on a paper diagnostic using a 0-12 scale where 0-5 was deemed to be very low, 6-9 was deemed low and 10-12 was deemed normal-high.|Baseline, 30 mins post dietary acid challenge|The PP population was defined as those subjects in the ITT population who have at least one assessment of efficacy considered unaffected by protocol violation. Assessments of efficacy considered affected by protocol violation was excluded from PP analyses. The primary population was the PP population.||scores on a scale||Standard Deviation|Mean
636734|NCT02533466|Secondary|Change From Baseline of pH Measurement 7 Hours Post Dietary Acid Challenge|Saliva stored at 0 - 20°C was used for determining pH|Baseline, 7 hours post dietary acid challenge|The PP population was defined as those subjects in the ITT population who have at least one assessment of efficacy considered unaffected by protocol violation. Assessments of efficacy considered affected by protocol violation was excluded from PP analyses. The primary population was the PP population||pH units||Standard Deviation|Mean
636735|NCT02533466|Secondary|Change From Baseline of pH Measurement at 30 Mins Post Dietary Acid Challenge|Saliva stored at 0 - 20°C was used for determining pH|Baseline, 30 mins post dietary acid challenge|The PP population was defined as those subjects in the ITT population who have at least one assessment of efficacy considered unaffected by protocol violation. Assessments of efficacy considered affected by protocol violation was excluded from PP analyses. The primary population was the PP population||pH units||Standard Deviation|Mean
636736|NCT02533466|Secondary|Change From Baseline of Salivary Calcium Concentration 7 Hours Post Dietary Acid Challenge|Saliva stored at 0 - 20°C was used for determining calcium concentration|Baseline, 7 hours post dietary acid challenge|The PP population was defined as those subjects in the ITT population who have at least one assessment of efficacy considered unaffected by protocol violation. Assessments of efficacy considered affected by protocol violation was excluded from PP analyses. The primary population was the PP population.||ppm||Standard Deviation|Mean
636737|NCT02533466|Secondary|Change From Baseline of Salivary Calcium Concentration at 30 Mins Post Dietary Acid Challenge|Saliva stored at 0 - 20°C was used for determining calcium concentration|Baseline, 30 mins post dietary acid challenge|The PP population was defined as those subjects in the ITT population who have at least one assessment of efficacy considered unaffected by protocol violation. Assessments of efficacy considered affected by protocol violation was excluded from PP analyses. The primary population was the PP population.||ppm||Standard Deviation|Mean
636738|NCT02533466|Secondary|Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 7 Hours Post Acid Challenge|"The impressions of the tooth surface were analysed using scanning electron microscopy (SEM) to investigate changes in the enamel surface topography to determine degree of early stage enamel erosion. Interrogation of the tooth surface via impressions using SEM followed by visual image analysis was used to investigate the enamel surface topography.
The Images were graded as follows:
- No signs of surface erosive wear (no evidence of the “lock and key” structure)
- Early signs of erosive surface changes
- Mild signs of erosive surface changes (early signs of the “lock and key” structure).
- Moderate signs of erosive surface changes
- Severe signs of erosive surface changes (“lock and key” structure and enamel “pits”) X - Not evaluable"|Baseline, 7 hours post acid challenge|The PP population was defined as those subjects in the ITT population who have at least one assessment of efficacy considered unaffected by protocol violation. Assessments of efficacy considered affected by protocol violation were excluded from PP analyses. The primary population was the PP population.||Scores on grading scale||Full Range|Median
636739|NCT02533466|Secondary|Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 4 Hours Post Acid Challenge|"The impressions of the tooth surface were analysed using scanning electron microscopy (SEM) to investigate changes in the enamel surface topography to determine degree of early stage enamel erosion. Interrogation of the tooth surface via impressions using SEM followed by visual image analysis was used to investigate the enamel surface topography.
The Images were graded as follows:
- No signs of surface erosive wear (no evidence of the “lock and key” structure)
- Early signs of erosive surface changes
- Mild signs of erosive surface changes (early signs of the “lock and key” structure).
- Moderate signs of erosive surface changes
- Severe signs of erosive surface changes (“lock and key” structure and enamel “pits”) X - Not evaluable"|Baseline, 4 hours post acid challenge|The PP population was defined as those subjects in the ITT population who have at least one assessment of efficacy considered unaffected by protocol violation. Assessments of efficacy considered affected by protocol violation were excluded from PP analyses. The primary population was the PP population.||Scores on grading scale||Full Range|Median
636740|NCT02533466|Secondary|Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 2 Hours Post Acid Challenge.|"The impressions of the tooth surface were analysed using scanning electron microscopy (SEM) to investigate changes in the enamel surface topography to determine degree of early stage enamel erosion. Interrogation of the tooth surface via impressions using SEM followed by visual image analysis was used to investigate the enamel surface topography.
The Images were graded as follows:
- No signs of surface erosive wear (no evidence of the “lock and key” structure)
- Early signs of erosive surface changes
- Mild signs of erosive surface changes (early signs of the “lock and key” structure).
- Moderate signs of erosive surface changes
- Severe signs of erosive surface changes (“lock and key” structure and enamel “pits”) X - Not evaluable"|Baseline, 2 hours post acid challenge|The PP population was defined as those subjects in the ITT population who have at least one assessment of efficacy considered unaffected by protocol violation. Assessments of efficacy considered affected by protocol violation were excluded from PP analyses. The primary population was the PP population.||Scores on grading scale||Full Range|Median
666639|NCT01754194|Secondary|Health Resource Utilization - Durantion of Sugery||12 Months|||Minutes||Standard Deviation|Mean
636741|NCT02533466|Primary|Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Immediately Following an Acid Challenge|"The impressions of the tooth surface were analysed using scanning electron microscopy (SEM) to investigate changes in the enamel surface topography to determine degree of early stage enamel erosion. Interrogation of the tooth surface via impressions using SEM followed by visual image analysis was used to investigate the enamel surface topography.
The Images were graded as follows:
- No signs of surface erosive wear (no evidence of the “lock and key” structure)
- Early signs of erosive surface changes
- Mild signs of erosive surface changes (early signs of the “lock and key” structure).
- Moderate signs of erosive surface changes
- Severe signs of erosive surface changes (“lock and key” structure and enamel “pits”) X - Not evaluable"|Baseline, 30 minutes post dietary acid challenge|The Per Protocol (PP) population was defined as those subjects in the ITT (intent to treat) population who have at least one assessment of efficacy considered unaffected by protocol violation. Assessments of efficacy considered affected by protocol violation were excluded from PP analyses. The primary population was the PP population.||Scores on grading scale||Full Range|Median
636742|NCT02533401|Primary|Percentage of Participants With Complete Response (CR), Nodular Partial Response (nPR), or Partial Response (PR)|Treatment response was monitored throughout the study and assessed using standardized criteria. CR was defined as hemoglobin ≥11 grams per deciliter (g/dL), lymphocytes less than (<) 4000 cells per cubic millimeter (cells/mm^3), neutrophils greater than (>) 1500 cells/mm^3, platelets >100,000 cells/mm^3, bone marrow (BM) biopsy with <30% lymphocytes with no lymphocytic infiltrates, no evidence of lymphoid nodules on physical exam, and performance status of 0. PR was defined as >50% decrease in size of enlarged lymph nodes, hepatomegaly, and splenomegaly, with peripheral counts meeting the same criteria as CR or ≥50% improvement from pre-treatment values. Participants with lymphoid nodules on BM biopsy who otherwise met CR criteria were considered nPR. The percentage of participants with each level of best overall response was calculated.|Up to 4 years (assessed every 3 months during 6-month treatment period, every 2 months during 6-month safety follow-up, then every 3 months during 3-year safety follow-up)|All Participants Enrolled.||percentage of participants|||Number
636743|NCT02533401|Primary|Overall Survival (OS)|Participants were followed for survival throughout the study. OS was defined as the time from study inclusion until death from any cause and was estimated using Kaplan-Meier analysis|Up to 5 years (from Baseline until death)|All Participants Enrolled.||months||95% Confidence Interval|Mean
636744|NCT02533401|Primary|Percentage of Participants Who Died|Participants were followed for survival throughout the study. The percentage of participants who died of any cause during the study was calculated.|Up to 5 years (from Baseline until death)|All Participants Enrolled.||percentage of participants|||Number
636745|NCT02533401|Primary|Progression-Free Survival (PFS)|Treatment response was monitored throughout the study and assessed using standardized criteria. Disease progression was defined as the occurrence of at least one of the following: ≥50% increase in the longest diameter of at least two enlarged lymph nodes, increase in spleen and/or liver size by at least 2 cm from Baseline as determined by measurement below the costal margin, or ≥50% increase in the number of circulating lymphocytes. PFS was defined as the time from study inclusion until first event of disease progression or death and was estimated using Kaplan-Meier analysis.|Up to 5 years (from Baseline until disease progression or death, whichever occurred first)|All Participants Enrolled.||months||95% Confidence Interval|Mean
636746|NCT02533401|Primary|Percentage of Participants With Death or Disease Progression|Treatment response was monitored throughout the study and assessed using standardized criteria. Disease progression was defined as the occurrence of at least one of the following: greater than or equal to (≥) 50 percent (%) increase in the longest diameter of at least two enlarged lymph nodes, increase in spleen and/or liver size by at least 2 centimeters (cm) from Baseline as determined by measurement below the costal margin, or ≥50% increase in the number of circulating lymphocytes. The percentage of participants with death or documented disease progression at any time during the study was calculated.|Up to 5 years (from Baseline until disease progression or death, whichever occurred first)|All Participants Enrolled.||percentage of participants|||Number
636747|NCT02533258|Secondary|Number of Participants Discontinued Due to Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|From initiation of axitinib treatment up to end of the study (up to 40 months)|Safety population included all the enrolled participants who received at least one dose of the axitinib. Here 'number of participants analyzed' signifies participants evaluable for this outcome measure.||partcicipants|||Number
636748|NCT02533258|Secondary|Number of Participants With Treatment-Related Adverse Events (AEs)|A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug.|From initiation of axitinib treatment up to end of the study (up to 40 months)|Safety population included all the enrolled participants who received at least one dose of the axitinib. Here 'number of participants analyzed' signifies participants evaluable for this outcome measure.||participants|||Number
636749|NCT02533258|Secondary|Number of Participants With Adverse Events (AEs) by Severity|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severity of the AEs was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Grade 1= mild; Grade 2= moderate; Grade 3= severe; Grade 4= life-threatening or disabling; Grade 5= death related to AE.|From initiation of axitinib treatment up to end of the study (up to 40 months)|Safety population included all the enrolled participants who received at least one dose of the axitinib. Here 'number of participants analyzed' signifies participants evaluable for this outcome measure.||participants|||Number
636750|NCT02533258|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life­ threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment-emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-­serious events.|From initiation of axitinib treatment up to end of the study (up to 40 months)|Safety population included all the enrolled participants who received at least one dose of the axitinib.||participants|||Number
636751|NCT02533258|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time duration in months from start of study treatment to the first documentation of PD or to death due to any cause, whichever occured first. PD was assessed by RECIST version 1.1. and defined as >=20% increase in the sum of the diameters of the target lesions taking as a reference the smallest sum on study (this included the baseline sum if that was the smallest on study) or unequivocal progression in non-target lesions or the appearance of 1 or more new lesions. Progression free survival based on investigators' judgment on medical records was calculated.|From initiation of axitinib treatment until PD or death from any cause (up to 40 months)|Efficacy population included all the participants who were enrolled in the study.||months||95% Confidence Interval|Median
636752|NCT02533258|Secondary|Duration of Response|Duration of response was defined as time from first documentation of objective tumor response (CR or PR), that was subsequently confirmed, to the first documentation of PD or to death due to any cause, whichever occurred first as per RECIST version 1.1. CR was defined as disappearance of all target, non-target lesions and all lymph nodes decreased to non-pathological in size (<10 mm short axis). PR was defined as at least 30% decrease in sum of diameters of target lesions taking as reference the baseline sum, without progression of non-target lesions, no appearance of new lesions. PD was defined as >=20% increase in sum of diameters of the target lesions taking as a reference smallest sum on study (this included the baseline sum if that was the smallest on study) or unequivocal progression in non-target lesions or appearance of 1 or more new lesions.|From initiation of axitinib treatment until PD or death from any cause (up to 40 months)|Efficacy population included all the participants who were enrolled in the study. Here 'number of participants analyzed' signifies participants who achieved a confirmed CR or PR.||months||95% Confidence Interval|Median
636753|NCT02533258|Secondary|Objective Response Rate (ORR)|ORR was defined as percentage of participants with confirmed complete response (CR) or partial response (PR) according to response evaluation criteria in solid tumors (RECIST) version 1.1. CR was defined as disappearance of all target, non-target lesions and all lymph nodes decreased to non-pathological in size (less than [<]10 millimeter [mm] short axis). PR was defined as at least 30 percent (%) decrease in sum of diameters of target lesions taking as reference the baseline sum, without progression of non-target lesions, no appearance of new lesions. Progression of disease (PD) was defined as greater than equal to (>=) 20% increase in sum of diameters of the target lesions taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study) or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. Response evaluation was based on investigators' judgment.|From initiation of axitinib treatment until PD or death from any cause (up to 40 months)|Efficacy population included all the participants who were enrolled in the study.||percentage of participants|||Number
636754|NCT02533258|Primary|Mean Daily Dose of Axitinib||From initiation of axitinib treatment up to the end of the study (up to 40 months)|Efficacy population included all the participants who were enrolled in the study.||milligram||Standard Deviation|Mean
636755|NCT02533258|Primary|Duration of Axitinib Treatment||From initiation of axitinib treatment up to the end of the study (up to 40 months)|Efficacy population included all the participants who were enrolled in the study.||months||95% Confidence Interval|Median
636756|NCT02532998|Secondary|Pharmacodynamics of AZD9977 by Assessment of Total Urine Volume Excreted Cumulatively and During Each of the Urine Collection Intervals|"Pharmacodynamics of AZD9977 by assessment of total urine volume excreted cumulatively and during each of the urine collection intervals.
Pharmacodynamics of AZD9977 after single dosing of AZD9977 with fludrocortisone and/or eplerenone"|From 8 hours before dosing until 24 hours after dosing|The PD analysis set will consist of all participants in the SAF with at least one evaluable sum of the logarithm of the sodium/potassium ratio from two hours up to eight hours post dose, and who have no major protocol deviations thought to impact on the analysis of the PD data.||mL||Standard Deviation|Mean
636757|NCT02532998|Secondary|Pharmacodynamics of AZD9977 Assessed Per Urine Production for Each Urine Collection Time Interval.|"Pharmacodynamics of AZD9977 assessed per urine production for each urine collection time interval.
Pharmacodynamics of AZD9977 after single dosing of AZD9977 with fludrocortisone and/or eplerenone."|From 8 hours before dosing until 24 hours after dosing|The PD analysis set consisted of all participants in the SAF with at least one evaluable sum of the logarithm of the sodium/potassium ratio from two hours up to eight hours post dose, and who had no major protocol deviations thought to impact on the analysis of the PD data.||mL||Standard Deviation|Mean
636758|NCT02532998|Secondary|Pharmacodynamics of AZD9977 by Assessment of Total Potassium Excreted Cumulatively and During Each of the Urine Collection Intervals|"Pharmacodynamics of AZD9977 by assessment of total potassium excreted cumulatively and during each of the urine collection intervals.
Pharmacodynamics of AZD9977 after single dosing of AZD9977 with fludrocortisone in comparison to AZD9977 placebo."|From 0 to 24 hours after dosing|The PD analysis set will consist of all participants in the SAF with at least one evaluable sum of the logarithm of the sodium/potassium ratio from two hours up to eight hours post dose, and who have no major protocol deviations thought to impact on the analysis of the PD data.||mmol||Standard Deviation|Mean
636759|NCT02532998|Secondary|Pharmacodynamics of AZD9977 Assessed Per Fractional Potassium Excretion in Urine for Each Urine Collection Time Interval.|"Pharmacodynamics of AZD9977 assessed per fractional potassium excretion in urine for each urine collection time interval.
Pharmacodynamics of AZD9977 after single dosing of AZD9977 with fludrocortisone and/or eplerenone"|From 0 to 8 hours post dosing|The PD analysis set consisted of all participants in the SAF with at least one evaluable sum of the logarithm of the sodium/potassium ratio from two hours up to eight hours post dose, and who had no major protocol deviations thought to impact on the analysis of the PD data.||% value||Standard Deviation|Mean
636760|NCT02532998|Secondary|Pharmacodynamics of AZD9977 Assessed Per Total Sodium Excreted Cumulatively and During Each of the Urine Collection Intervals.|"Pharmacodynamics of AZD9977 by assessment of total sodium excreted cumulatively and during each of the urine collection intervals.
Pharmacodynamics of AZD9977 after single dosing of AZD9977 with fludrocortisone and/or eplerenone."|From 0 to 24 hours after dosing|The PD analysis set consisted of all participants in the SAF with at least one evaluable sum of the logarithm of the sodium/potassium ratio from two hours up to eight hours post dose, and who had no major protocol deviations thought to impact on the analysis of the PD data.||mmol||Standard Deviation|Mean
637046|NCT02512393|Primary|Heat Pain Threshold|Quantitative Sensory Testing (QST) by using heat pain delivered by using thermal probe on the skin.|baseline|||Celsius||Standard Deviation|Mean
636761|NCT02532998|Secondary|Pharmacodynamics of AZD9977 Assessed by Estimating the Fractional Sodium Excretion in Urine for Each Urine Collection Time Interval.|"Pharmacodynamics of AZD9977 by assessment of fractional sodium excretion in urine for each urine collection time interval.
Pharmacodynamics of AZD9977 after single dosing of AZD9977 with fludrocortisone and/or eplerenone."|From 0 to 8 hours after dosing|The PD analysis set consisted of all participants in the SAF with at least one evaluable sum of the logarithm of the sodium/potassium ratio from two hours up to eight hours post dose, and who had no major protocol deviations thought to impact on the analysis of the PD data.||% value||Standard Deviation|Mean
636762|NCT02532998|Secondary|Number of Participants With Clinically Significant Safety Laboratory Tests Values.|Clinically significant safety laboratory test values included hematology, clinical chemistry, urinalysis and urine chemistry, including urine creatinine and uric acid measurements. Viral serology and urine drugs of abuse, alcohol and cotinine were assessed for eligibility. If deterioration in laboratory value was associated with clinical symptoms and/or signs, the symptom or sign were reported as an adverse event and the associated laboratory result was considered as additional information. Laboratory results were listed and summarized according to change from baseline and repeat/unscheduled measurements. Any out of range laboratory results were flagged in the individual listings.|From screening to post-study visit, up to 10 weeks|The SAF included all participants who received at least one dose of any of the administered products (fludrocortisone, eplerenone or AZD9977/matching placebo) and for whom any safety data post-fludrocortisone dose were available.||Participants|||Number
636763|NCT02532998|Secondary|Number of Participants With Clinically Significant Physical Examination Values.|"Number of participants with clinically significant physical examination values.
The complete physical examinations included an assessment of the general appearance, respiratory, cardiovascular, abdomen, skin, head, and neck (including ears, eyes, nose, mouth and throat), lymph nodes, thyroid, musculoskeletal and neurological systems. The brief physical examinations included an assessment of the general appearance, skin, abdomen, cardiovascular and respiratory systems. The results of the physical examination were listed by body system for each subject. Body weight was listed by participant and time-point. Any new or aggravated clinically relevant abnormal medical finding at a physical examination as compared with the baseline assessment were reported as an adverse event (AE)."|From screening to post-study visit, up to 10 weeks|The SAF included all participants who received at least one dose of any of the administered products (fludrocortisone, eplerenone or AZD9977/matching placebo) and for whom any safety data post-fludrocortisone dose were available.||Participants|||Number
636764|NCT02532998|Secondary|Number of Participants With Clinically Significant Electrocardiogram.|"Clinically significant electrocardiogram values were recorded for all participants in the study.
A 12-lead ECG was obtained after each subject had rested in the supine position for at least 10 minutes and was performed in accordance with the Schedule of Assessments of study protocol.
The investigator judged the overall interpretation as normal or abnormal. If abnormal, it would have been decided as to whether or not the abnormality was clinically significant and the reason for the abnormality would have been recorded. The investigator could add extra 12-lead resting ECG safety assessments if there were any abnormal findings of if the investigator considered it was necessary for any other safety reason. These assessments would have been entered as an unscheduled assessment."|From screening to post-study visit, up to 10 weeks|The SAF included all participants who received at least one dose of any of the administered products (fludrocortisone, eplerenone or AZD9977/matching placebo) and for whom any safety data post-fludrocortisone dose were available.||Participants|||Number
636765|NCT02532998|Secondary|Number of Participants With Clinically Significant Pulse Rate.|"Clinically significant pulse rate (if available) was recorded for all participants in the study.
The pulse was obtained after each subject had rested in the supine position for at least 5 minutes and was performed in accordance with the Schedule of Assessments of study protocol.
Abnormal findings in pulse rate, after 10 minutes resting in the supine position, was defined as following:
• Pulse < 45 or > 85 beats per minute (bpm)"|From screening to post-study visit, up to 10 weeks|The SAF included all subjects who received at least one dose of any of the administered products (fludrocortisone, eplerenone or AZD9977/matching placebo) and for whom any safety data post-fludrocortisone dose were available.||Participants|||Number
636766|NCT02532998|Secondary|Number of Participants With Clinically Significant Blood Pressure Values.|"Clinically significant blood pressure values (if available) were recorded for all participants.
The systolic blood pressure (mmHg) and diastolic BP (mmHg) was obtained after each subject had rested in the supine position for at least 5 minutes and was performed in accordance with the Schedule of Assessments of study protocol.
Abnormal findings in blood pressure after 10 minutes resting in the supine position was defined as following:
Systolic blood pressure (SBP) < 90 mmHg or ≥ 140 mmHg
Diastolic blood pressure (DBP) < 50 mmHg or ≥ 90 mmHg."|From screening to post-study visit, up to 10 weeks|The safety analysis set (SAF) included all participants who received at least one dose of any of the administered products (fludrocortisone, eplerenone or AZD9977/matching placebo) and for whom any safety data post-fludrocortisone dose were available.||Participants|||Number
636767|NCT02532998|Secondary|Pharmacodynamics of AZD9977 Assessed Per Sodium/Potassium Ratio in Urine in AZD9977 Treatment With Placebo Versus Treatment With AZD9977.|"The sum over the urine collection intervals of the logarithm of the urinary sodium/potassium ratio from two hours to eight hours post-dose.
NOTE: Note: Data are presented as the sum of the difference between ln(Na+) and ln(K+) over the collected intervals 2-4, 4-6 and 6-8 hours."|From 2 hours post dose to 8 hours post dose|The pharmacodynamic (PD) analysis set consisted of all participants in the safety analysis set (SAF) with at least one evaluable sum of the logarithm of the sodium/potassium ratio from two hours up to eight hours post dose, and who had no major protocol deviations thought to impact on the analysis of the PD data.||sodium/potassium ratio||Standard Deviation|Mean
636768|NCT02532998|Secondary|Area Under Plasma Concentration-time Curve From Zero Extrapolated to Infinity (AUC) of Eplerenone.|Pre IMP dose and post IMP dose at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24 hours|From 2 hours post dose to 8 hours post dose|The eplerenone PK analysis set consisted of all participants who received at least one dose of eplerenone for whom at least one of the primary PK parameters was evaluable and who had no major protocol deviations thought to impact on the analysis of the eplerenone PK data.||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
637047|NCT02512393|Primary|Short Physical Performance Battery (SPPB)|This is a group of measures that combines the results of the gait speed, chair stand, and balance tests. The score ranges from 0 (worst performance) to 12 (best performance).|day 5|||units on a scale||Standard Deviation|Mean
636769|NCT02532998|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to t Hours After Dosing (AUC(0-t)) of Eplerenone.|Pre IMP dose and post IMP dose at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24 hours|From 2 hours post dose to 8 hours post dose|The eplerenone PK analysis set consisted of all participants who received at least one dose of eplerenone for whom at least one of the primary PK parameters was evaluable and who had no major protocol deviations thought to impact on the analysis of the eplerenone PK data.||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
636770|NCT02532998|Secondary|Observed Maximum Concentration (Cmax) of Eplerenone.|Pre IMP dose and post IMP dose at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24 hours|From 2 hours post dose to 8 hours post dose|The eplerenone PK analysis set consisted of all participants who received at least one dose of eplerenone for whom at least one of the primary PK parameters was evaluable and who had no major protocol deviations thought to impact on the analysis of the eplerenone PK data.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
636771|NCT02532998|Secondary|Time to Reach Maximum Concentration (Tmax) of Eplerenone.|Pre IMP dose and post IMP dose at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24 hours|From 2 hours post dose to 8 hours post dose|The eplerenone PK analysis set consisted of all participants who received at least one dose of eplerenone for whom at least one of the primary PK parameters was evaluable and who had no major protocol deviations thought to impact on the analysis of the eplerenone PK data.||h||Full Range|Median
636772|NCT02532998|Secondary|Terminal Half-life (t½λz) of Eplerenone.|Pre IMP dose and post IMP dose at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24 hours|From 2 hours post dose to 8 hours post dose|The eplerenone PK analysis set consisted of all participants who received at least one dose of eplerenone for whom at least one of the primary PK parameters was evaluable and who had no major protocol deviations thought to impact on the analysis of the eplerenone PK data.||h||Standard Deviation|Mean
636773|NCT02532998|Secondary|Apparent Clearance (CL/F) of Eplerenone.|Pre IMP dose and post IMP dose at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24 hours|From 2 hours post dose to 8 hours post dose|The eplerenone PK analysis set consisted of all participants who received at least one dose of eplerenone for whom at least one of the primary PK parameters was evaluable and who had no major protocol deviations thought to impact on the analysis of the eplerenone PK data.||L/h||Geometric Coefficient of Variation|Geometric Mean
636774|NCT02532998|Secondary|Apparent Volume of Distribution at Terminal Phase (Vz/F) of Eplerenone.|Pre IMP dose and post IMP dose at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24 hours|From 2 hours post dose to 8 hours post dose|The eplerenone PK analysis set consisted of all participants who received at least one dose of eplerenone for whom at least one of the primary PK parameters was evaluable and who had no major protocol deviations thought to impact on the analysis of the eplerenone PK data.||L||Geometric Coefficient of Variation|Geometric Mean
636775|NCT02532998|Secondary|Apparent Volume of Distribution at Terminal Phase (Vz/F) of AZD9977.|Pre IMP dose and post IMP dose at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24 hours|From 2 hours post dose to 8 hours post dose|The AZD9977 PK analysis set consisted of all participants who received at least one dose of AZD9977 for whom at least one of the primary PK parameters was evaluable and who had no major protocol deviations thought to impact on the analysis of the AZD9977 PK data.||L||Geometric Coefficient of Variation|Geometric Mean
636776|NCT02532998|Secondary|Apparent Clearance (CL/F) of AZD9977.|Pre IMP dose and post IMP dose at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24 hours|From 2 hours post dose to 8 hours post dose|The AZD9977 PK analysis set consisted of all participants who received at least one dose of AZD9977 for whom at least one of the primary PK parameters was evaluable and who had no major protocol deviations thought to impact on the analysis of the AZD9977 PK data.||L/h||Geometric Coefficient of Variation|Geometric Mean
636777|NCT02532998|Secondary|Terminal Half-life (t½λz) of AZD9977.|Pre IMP dose and post IMP dose at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24 hours|From 2 hours post dose to 8 hours post dose|The AZD9977 PK analysis set consisted of all participants who received at least one dose of AZD9977 for whom at least one of the primary PK parameters was evaluable and who had no major protocol deviations thought to impact on the analysis of the AZD9977 PK data.||h||Standard Deviation|Mean
636778|NCT02532998|Secondary|Time to Reach Maximum Concentration (Tmax) of AZD9977.|Pre IMP dose and post IMP dose at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24 hours|From 2 hours post dose to 8 hours post dose|The AZD9977 PK analysis set consisted of all subjects who received at least one dose of AZD9977 for whom at least one of the primary PK parameters was evaluable and who had no major protocol deviations thought to impact on the analysis of the AZD9977 PK data.||h||Full Range|Median
636779|NCT02532998|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to t Hours After Dosing (AUC[0-t]) of AZD9977.|Pre IMP dose and post IMP dose at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24 hours|From 2 hours post dose to 8 hours post dose|The AZD9977 PK analysis set consisted of all participants who received at least one dose of AZD9977 for whom at least one of the primary PK parameters was evaluable and who had no major protocol deviations thought to impact on the analysis of the AZD9977 PK data.||h*nmol/L||Geometric Coefficient of Variation|Geometric Mean
636780|NCT02532998|Secondary|Area Under Plasma Concentration-time Curve From Zero Extrapolated to Infinity (AUC) of AZD9977.|Pre IMP dose and post IMP dose at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24 hours|From 2 hours post dose to 8 hours post dose|The AZD9977 PK analysis set consisted of all participants who received at least one dose of AZD9977 for whom at least one of the primary PK parameters was evaluable and who had no major protocol deviations thought to impact on the analysis of the AZD9977 PK data.||h*nmol/L||Geometric Coefficient of Variation|Geometric Mean
636781|NCT02532998|Secondary|Observed Maximum Concentration (Cmax) of AZD9977|Pre IMP dose and post IMP dose at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24 hours|From 2 hours post dose to 8 hours post dose|The AZD9977 PK analysis set consisted of all participants who received at least one dose of AZD9977 for whom at least one of the primary PK parameters was evaluable and who had no major protocol deviations thought to impact on the analysis of the AZD9977 PK data.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
636893|NCT02525536|Primary|Cmax: Maximum Observed Serum Concentration for AMG 386 After Week 4 Dose|Cmax is the peak serum concentration of a drug after administration, obtained directly from the serum concentration-time curve.|Week 4: predose, 1, 2, 6, 24, 48, 96, 168 and 264 hours after end of infusion|Pharmacokinetic analysis set: all participants who had at least 1 evaluable serum concentrations, received at least 1 dose of AMG 386, and had Week 4 assessment available.||mcg/mL||Standard Deviation|Mean
636782|NCT02532998|Primary|Pharmacodynamics of AZD9977 Assessed Per Sodium/Potassium Ratio in Urine in Eplerenone Treatment Versus a Combination Treatment of Eplerenone and AZD9977.|"The sum over the urine collection intervals of the logarithm of the urinary sodium/potassium ratio from two hours to eight hours post-dose.
NOTE: Data are presented as the sum of the difference between ln(Na+) and ln(K+) over the collected intervals 2-4, 4-6 and 6-8 hours."|From 2 hours post dose to 8 hours post dose|The pharmacodynamic (PD) analysis set consisted of all participants in the safety analysis set (SAF) with at least one evaluable sum of the logarithm of the sodium/potassium ratio from two hours up to eight hours post dose, and who had no major protocol deviations thought to impact on the analysis of the PD data.||sodium/potassium ratio||Standard Deviation|Mean
636783|NCT02532374|Primary|Area Under the Concentration-time Curve From Start of Product Use to 10 Minutes After Start of Product Use (AUC0-10) of Nicotine Following Single Use of P3L 150 µg/Puff|"T0 = start of product use.
Derived from multiple blood sampling pre- and post-product use on Visit 6 (over 240 minutes post-product use).
Geometric Least Squares (geometric LS) means are provided."|Visit 6: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.|"PK population: all the subjects who have signed the informed consent, completed at least one P3L product use period and for whom at least one PK parameter can been derived.
=> 16 subjects - 1 subject withdrew after the product test at the admission visit - 1 subject discontinued by the Principal Investigator = 14 subjects"||h*ng/mL||95% Confidence Interval|Least Squares Mean
636784|NCT02532374|Primary|Area Under the Concentration-time Curve From Start of Product Use to 10 Minutes After Start of Product Use (AUC0-10) of Nicotine Following Single Use of P3L 80 µg/Puff|"T0 = start of product use.
Derived from multiple blood sampling pre- and post-product use on Visit 5 (over 240 minutes post-product use).
Geometric Least Squares (geometric LS) means are provided."|Visit 5: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.|"PK population: all the subjects who have signed the informed consent, completed at least one P3L product use period and for whom at least one PK parameter can been derived.
=> 16 subjects - 1 subject withdrew after the product test at the admission visit - 1 subject discontinued by the Principal Investigator = 14 subjects"||h*ng/mL||95% Confidence Interval|Least Squares Mean
636785|NCT02532374|Primary|Area Under the Concentration-time Curve From Start of Product Use to 10 Minutes After Start of Product Use (AUC0-10) of Nicotine Following Single Use of P3L 50 µg/Puff|"T0 = start of product use.
Derived from multiple blood sampling pre- and post-product use on Visit 4 (over 240 minutes post-product use).
Geometric Least Squares (geometric LS) means are provided."|Visit 4: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.|"PK population: all the subjects who have signed the informed consent, completed at least one P3L product use period and for whom at least one PK parameter can been derived.
=> 16 subjects - 1 subject withdrew after the product test at the admission visit =15 subjects"||h*ng/mL||95% Confidence Interval|Least Squares Mean
636786|NCT02532374|Primary|Area Under the Concentration-time Curve From Start of Product Use to 10 Minutes After Start of Product Use (AUC0-10) of Nicotine Following Single Use of Nicorette® Inhalator|"T0 = start of product use.
Derived from multiple blood sampling pre- and post-product use on Visit 3 (over 240 minutes post-product use).
Geometric Least Squares (geometric LS) means are provided."|Visit 3: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.|"PK population: all the subjects who have signed the informed consent, completed at least one P3L product use period and for whom at least one PK parameter can been derived.
=> 16 subjects - 1 subject withdrew after the product test at the admission visit =15 subjects"||h*ng/mL||95% Confidence Interval|Least Squares Mean
636787|NCT02532374|Primary|Area Under the Concentration-time Curve From Start of Product Use to the Last Quantifiable Time Point (AUC0-last) of Nicotine Following Single Use of P3L 150 µg/Puff|"T0 = start of product use.
Derived from multiple blood sampling pre- and post-product use on Visit 6 (over 240 minutes post-product use).
Geometric Least Squares (geometric LS) means are provided."|Visit 6: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.|"PK population: all the subjects who have signed the informed consent, completed at least one P3L product use period and for whom at least one PK parameter can been derived.
=> 16 subjects - 1 subject withdrew after the product test at the admission visit - 1 subject discontinued by the Principal Investigator = 14 subjects"||h*ng/mL||95% Confidence Interval|Least Squares Mean
636788|NCT02532374|Primary|Area Under the Concentration-time Curve From Start of Product Use to the Last Quantifiable Time Point (AUC0-last) of Nicotine Following Single Use of P3L 80 µg/Puff|"T0 = start of product use.
Derived from multiple blood sampling pre- and post-product use on Visit 5 (over 240 minutes post-product use).
Geometric Least Squares (geometric LS) means are provided."|Visit 5: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.|"PK population: all the subjects who have signed the informed consent, completed at least one P3L product use period and for whom at least one PK parameter can been derived.
=> 16 subjects - 1 subject withdrew after the product test at the admission visit - 1 subject discontinued by the Principal Investigator = 14 subjects"||h*ng/mL||95% Confidence Interval|Least Squares Mean
636789|NCT02532374|Primary|Area Under the Concentration-time Curve From Start of Product Use to the Last Quantifiable Time Point (AUC0-last) of Nicotine Following Single Use of P3L 50 µg/Puff|"T0 = start of product use.
Derived from multiple blood sampling pre- and post-product use on Visit 4 (over 240 minutes post-product use).
Geometric Least Squares (geometric LS) means are provided."|Visit 4: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.|"PK population: all the subjects who have signed the informed consent, completed at least one P3L product use period and for whom at least one PK parameter can been derived.
=> 16 subjects - 1 subject withdrew after the product test at the admission visit =15 subjects"||h*ng/mL||95% Confidence Interval|Least Squares Mean
636821|NCT02529995|Primary|AUC(ss) of AZ5104 After Multiple Dosing|Pharmacokinetics of AZD9291 metabolites (AZ5104) after multiple dosing by assessment of area under the plasma concentration curve from time zero to the end of the dosing interval|PK blood samples are collected multiple times on Cycle 1 Day 8 and Cycle 2 Day 1.|Pharmacokinetic population - all patients who received at least 1 dose of AZD9291 and had at least 1 quantifiable plasma concentration collected post-dose without important protocol deviations/violations. Overall number of participants analyzed is the number of patients in Pharmacokinetic population who had available data for each PK variable.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
636790|NCT02532374|Primary|Area Under the Concentration-time Curve From Start of Product Use to the Last Quantifiable Time Point (AUC0-last) of Nicotine Following Single Use of Nicorette® Inhalator|"T0 = start of product use.
Derived from multiple blood sampling pre- and post-product use on Visit 3 (over 240 minutes post-product use).
Geometric Least Squares (geometric LS) means are provided."|Visit 3: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.|"PK population: all the subjects who have signed the informed consent, completed at least one P3L product use period and for whom at least one PK parameter can been derived.
=> 16 subjects - 1 subject withdrew after the product test at the admission visit =15 subjects"||h*ng/mL||95% Confidence Interval|Least Squares Mean
636791|NCT02532374|Primary|Time to the Maximum Concentration (Tmax) of Nicotine Following Single Use of P3L 150 µg/Puff|"T0 = start of product use.
Derived from multiple blood sampling pre- and post-product use on Visit 6 (over 240 minutes post-product use)."|Visit 6: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.|"PK population: all the subjects who have signed the informed consent, completed at least one P3L product use period and for whom at least one PK parameter can been derived.
=> 16 subjects - 1 subject withdrew after the product test at the admission visit - 1 subject discontinued by the Principal Investigator = 14 subjects"||minutes||Inter-Quartile Range|Median
636792|NCT02532374|Primary|Time to the Maximum Concentration (Tmax) of Nicotine Following Single Use of P3L 80 µg/Puff|"T0 = start of product use.
Derived from multiple blood sampling pre- and post-product use on Visit 5 (over 240 minutes post-product use)."|Visit 5: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.|"PK population: all the subjects who have signed the informed consent, completed at least one P3L product use period and for whom at least one PK parameter can been derived.
=> 16 subjects - 1 subject withdrew after the product test at the admission visit - 1 subject discontinued by the Principal Investigator = 14 subjects"||minutes||Inter-Quartile Range|Median
636793|NCT02532374|Primary|Time to the Maximum Concentration (Tmax) of Nicotine Following Single Use of P3L 50 µg/Puff|"T0 = start of product use.
Derived from multiple blood sampling pre- and post-product use on Visit 4 (over 240 minutes post-product use)."|Visit 4: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.|"PK population: all the subjects who have signed the informed consent, completed at least one P3L product use period and for whom at least one PK parameter can been derived.
=> 16 subjects - 1 subject withdrew after the product test at the admission visit =15 subjects"||minutes||Inter-Quartile Range|Median
636794|NCT02532374|Primary|Time to the Maximum Concentration (Tmax) of Nicotine Following Single Use of Nicorette® Inhalator|"T0 = start of product use.
Derived from multiple blood sampling pre- and post-product use on Visit 3 (over 240 minutes post-product use)."|Visit 3: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.|"PK population: all the subjects who have signed the informed consent, completed at least one P3L product use period and for whom at least one PK parameter can been derived.
=> 16 subjects - 1 subject withdrew after the product test at the admission visit =15 subjects"||minutes||Inter-Quartile Range|Median
636795|NCT02532374|Primary|Maximum Concentration (Cmax) of Nicotine Following Single Use of P3L 150 µg/Puff|"T0 = start of product use.
Derived from multiple blood sampling pre- and post-product use on Visit 6 (over 240 minutes post-product use).
Geometric Least Squares (geometric LS) means are provided."|Visit 6: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.|"PK population: all the subjects who have signed the informed consent, completed at least one P3L product use period and for whom at least one PK parameter can been derived.
=> 16 subjects - 1 subject withdrew after the product test at the admission visit - 1 subject discontinued by the Principal Investigator = 14 subjects"||ng/mL||95% Confidence Interval|Least Squares Mean
636796|NCT02532374|Primary|Maximum Concentration (Cmax) of Nicotine Following Single Use of P3L 80 µg/Puff|"T0 = start of product use.
Derived from multiple blood sampling pre- and post-product use on Visit 5 (over 240 minutes post-product use).
Geometric Least Squares (geometric LS) means are provided."|Visit 5: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.|"PK population: all the subjects who have signed the informed consent, completed at least one P3L product use period and for whom at least one PK parameter can been derived.
=> 16 subjects - 1 subject withdrew after the product test at the admission visit - 1 subject discontinued by the Principal Investigator = 14 subjects"||ng/mL||95% Confidence Interval|Least Squares Mean
636797|NCT02532374|Primary|Maximum Concentration (Cmax) of Nicotine Following Single Use of P3L 50 µg/Puff|"T0 = start of product use.
Derived from multiple blood sampling pre- and post-product use on Visit 4 (over 240 minutes post-product use).
Geometric Least Squares (geometric LS) means are provided."|Visit 4: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.|"PK population: all the subjects who have signed the informed consent, completed at least one P3L product use period and for whom at least one PK parameter can been derived.
=> 16 subjects - 1 subject withdrew after the product test at the admission visit =15 subjects"||ng/mL||95% Confidence Interval|Least Squares Mean
636798|NCT02532374|Primary|Maximum Concentration (Cmax) of Nicotine Following Single Use of Nicorette® Inhalator|"T0 = start of product use.
Derived from multiple blood sampling pre- and post-product use on Visit 3 (over 240 minutes post-product use).
Geometric Least Squares (geometric LS) means are provided."|Visit 3: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.|"PK population: all the subjects who have signed the informed consent, completed at least one P3L product use period and for whom at least one PK parameter can been derived.
=> 16 subjects - 1 subject withdrew after the product test at the admission visit =15 subjects"||ng/mL||95% Confidence Interval|Least Squares Mean
636822|NCT02529995|Primary|AUC(ss) of AZD9291 After Multiple Dosing|Pharmacokinetics of AZD9291 after multiple dosing by assessment of area under the plasma concentration curve from time zero to the end of the dosing interval|PK blood samples are collected multiple times on Cycle 1 Day 8 and Cycle 2 Day 1.|Pharmacokinetic population - all patients who received at least 1 dose of AZD9291 and had at least 1 quantifiable plasma concentration collected post-dose without important protocol deviations/violations. Overall number of participants analyzed is the number of patients in Pharmacokinetic population who had available data for each PK variable.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
636799|NCT02531867|Primary|Number of Participants With Adverse Events (AEs) Including Injection Site Reactions (ISRs) and Injection Associated Reactions (IARs)|Adverse events are any unwanted adverse medical occurrence in patients who are treated with a medicinal drug, whether or not considered drug-related. This includes events observed in patients administered with asfotase alfa between the first dose of asfotase alfa and the completion of patient’s last visit for the clinical study.|Events that occurred between the first dose of asfotase alfa and the completion of the patient's last visit, which was up to 5 months.|All patients who met all of the inclusion and none of the exclusion criteria were defined as the enrolled population, which was also the analysis population.The safety set comprised all patients who received at least 1 dose of the investigational drug.||Participants|||Count of Participants
636800|NCT02531646|Primary|Radlex Scale for Diagnostic Quality Ratings - DT Investigational Phantom Images|1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.|3 months|77 phantom image ratings from 7 radiologist readers (11 images rated x 7 readers) for Predicate & Invest. DT - Phantom Images arm above.||units on a scale|images|Standard Error|Mean
636801|NCT02531646|Primary|Radlex Scale for Diagnostic Quality Ratings - LT Predicate Phantom Images|1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.|3 months|77 phantom image ratings from 7 radiologist readers (11 images rated x 7 readers) for Predicate & Invest. DT - Phantom Images arm above.||units on a scale|images|Standard Error|Mean
636802|NCT02531646|Primary|Radlex Scale for Diagnostic Quality Ratings - DT Investigational - Scout & DT Volume|1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.|3 month|119 image ratings from 7 radiologist readers (17 images rated x 7 readers) for DT Investigational - Scout & DT Volume.||units on a scale|images|Standard Error|Mean
636803|NCT02531646|Primary|Radlex Scale for Diagnostic Quality Ratings - DT Reference 2 - PA and LAT Chest|1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.|3 months|119 image ratings from 7 radiologist readers (17 images rated x 7 readers) for Predicate & Invest. DT Reference 2 - PA and LAT Chest arm above.||units on a scale|images|Standard Error|Mean
636804|NCT02531646|Primary|Radlex Scale for Diagnostic Quality Ratings - DT Reference 1- PA Chest|1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.|3 months|119 image ratings from 7 radiologist readers (17 images rated x 7 readers) for Predicate & Invest. DT Reference 1 - PA Chest arm above.||units on a scale|images|Standard Error|Mean
636805|NCT02531646|Primary|Radlex Scale for Diagnostic Quality Ratings - DE Investigational Low Energy|1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.|3 months|||units on a scale|images|Standard Error|Mean
636868|NCT02527148|Secondary|Knee Pain|Pain at rest and pain during mobilization was measured using a 10 centimeter Visual Analogue Scale (VAS). Participants are asked to indicate their level of pain with 0 being no pain and 10 being the worst pain.|Preoperatively, 6-week, 6-months,12 months, 2 years and 5 years postoperatively||||||
637789|NCT02471612|Secondary|Length of Stay (LOS)|The mean duration of hospital stay or Length of Stay was recorded|30 days|||Days||Standard Deviation|Mean
636806|NCT02531646|Primary|Radlex Scale for Diagnostic Quality Ratings - DE Investigational High Energy|1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.|3 months|||units on a scale|images|Standard Error|Mean
636807|NCT02531646|Primary|Radlex Scale for Diagnostic Quality Ratings - DE Investigational Composite|1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.|3 months|||units on a scale|images|Standard Error|Mean
636808|NCT02531646|Primary|Radlex Scale for Diagnostic Quality Ratings - DE Predicate PA Chest|1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.|3 months|224 image ratings from 7 radiologist readers (32 images rated x 7 readers) for Predicate & Invest. DE - Human Subjects arm above.||units on a scale|images|Standard Error|Mean
636809|NCT02531308|Primary|Progression Free Survival|rate of progression in patients 2 years after diagonosis|2 year|Study terminated prematurely.|||||
636810|NCT02530671|Secondary|Comparison of BSI Between Periods||0-3, 9-12 months|||percentage of the original bristle field||Standard Deviation|Mean
636811|NCT02530671|Primary|Bristle Splay Index (BSI) After a Specific Time-of-use|A digital computer program (ImageJ, NIH, Bethesda, MD, USA) for evaluating the index was applied. All brushes were photographed from both top and side view in a standardized set-up including a benchmark (Lego GmbH (Gemeinschaft mit beschränkter Haft), Grasbrunn, Germany) as reference for measurement. Subsequently, an independent examiner (N.H.) measured the lengths twice. To devise the BSI formula the results were averaged and inserted. The formula is defined by: BSI (%) = ((a´- a)/a + (b´- b)/b + (c´- c)/c + (d´- d)/d)/4 x 100. BSI was standardized for usage time by dividing it by the number of days used (BSI/T).|3, 6, 9 and 12 months|||percentage of the original bristle field||Standard Deviation|Mean
636812|NCT02530671|Secondary|Pocket Probing Depths at 12months||12 months|||mm||Standard Deviation|Mean
636813|NCT02530671|Secondary|Percentage of Recession Sites Demonstrating a Change of ≥1mm||12 months|||percentage of sites|||Number
636814|NCT02530671|Secondary|Recession at All Buccal Sites||12 months|||mm||Standard Deviation|Mean
636815|NCT02530671|Primary|Gingival Recession at Sites With Preexisting Recessions ≥2mm||12 months|||mm||Standard Deviation|Mean
636816|NCT02530450|Secondary|% Time Spent in Hypoglycemia, Hyperglycemia, and Euglycemia||3 months and 6 months||||||
636817|NCT02530450|Primary|The Primary Outcome Measure Was Change in HgbA1c||0 months, 3 months and 6 months|||HbgA1c %||Inter-Quartile Range|Median
636818|NCT02529995|Secondary|Objective Response Rate (ORR)|Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. ORR is the percentage of patients with at least 1 visit response of CR or PR (according to independent review) that was confirmed at least 4 weeks later, prior to progression or further anti-cancer therapy.|Treatment discontinuation plus 28 days or 12 months after last subject first dose (LSFD). Results are based on data cut off of 28 Jan 2016 (Approximately 3 months after LSFD)|All patients who received at least 1 dose of study treatment and had measurable disease at baseline according to the independent review of baseline imaging data.||% of participants||95% Confidence Interval|Number
636819|NCT02529995|Primary|CL(ss)/F of AZD9291 After Multiple Dosing|Pharmacokinetics of AZD9291 after multiple dosing by assessment of apparent plasma clearance at steady state|PK blood samples are collected multiple times on Cycle 1 Day 8 and Cycle 2 Day 1.|Pharmacokinetic population - all patients who received at least 1 dose of AZD9291 and had at least 1 quantifiable plasma concentration collected post-dose without important protocol deviations/violations. Overall number of participants analyzed is the number of patients in Pharmacokinetic population who had available data for each PK variable.||L/h||Standard Deviation|Mean
636820|NCT02529995|Primary|AUC(ss) of AZ7550 After Multiple Dosing|Pharmacokinetics of AZD9291 metabolites (AZ7550) after multiple dosing by assessment of area under the plasma concentration curve from time zero to the end of the dosing interval|PK blood samples are collected multiple times on Cycle 1 Day 8 and Cycle 2 Day 1.|Pharmacokinetic population - all patients who received at least 1 dose of AZD9291 and had at least 1 quantifiable plasma concentration collected post-dose without important protocol deviations/violations. Overall number of participants analyzed is the number of patients in Pharmacokinetic population who had available data for each PK variable.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
636891|NCT02525536|Primary|Tmax: Time to Reach the Maximum Serum Concentration (Cmax) for AMG 386 After Week 4 Dose|Tmax is the time to reach the maximum serum concentration (Cmax), equal to time (hours) to Cmax.|Week 4: predose, 1, 2, 6, 24, 48, 96, 168 and 264 hours after end of infusion|Pharmacokinetic analysis set: all participants who had at least 1 evaluable serum concentrations, received at least 1 dose of AMG 386, and had Week 4 assessment available.||hr||Full Range|Median
636823|NCT02529995|Primary|C(ss, Max) of AZ7550 After Multiple Dosing|Pharmacokinetics of AZD9291 metabolites (AZ7550) after multiple dosing by assessment of maximum plasma concentration at steady state|PK blood samples are collected multiple times on Cycle 1 Day 8 and Cycle 2 Day 1.|Pharmacokinetic population - all patients who received at least 1 dose of AZD9291 and had at least 1 quantifiable plasma concentration collected post-dose without important protocol deviations/violations. Overall number of participants analyzed is the number of patients in Pharmacokinetic population who had available data for each PK variable.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
636824|NCT02529995|Primary|C(ss, Max) of AZ5104 After Multiple Dosing|Pharmacokinetics of AZD9291 metabolites (AZ5104) after multiple dosing by assessment of maximum plasma concentration at steady state|PK blood samples are collected multiple times on Cycle 1 Day 8 and Cycle 2 Day 1.|Pharmacokinetic population - all patients who received at least 1 dose of AZD9291 and had at least 1 quantifiable plasma concentration collected post-dose without important protocol deviations/violations. Overall number of participants analyzed is the number of patients in Pharmacokinetic population who had available data for each PK variable.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
636825|NCT02529995|Primary|C(ss, Max) of AZD9291 After Multiple Dosing|Pharmacokinetics of AZD9291 after multiple dosing by assessment of maximum plasma concentration at steady state|PK blood samples are collected multiple times on Cycle 1 Day 8 and Cycle 2 Day 1.|Pharmacokinetic population - all patients who received at least 1 dose of AZD9291 and had at least 1 quantifiable plasma concentration collected post-dose without important protocol deviations/violations. Overall number of participants analyzed is the number of patients in Pharmacokinetic population who had available data for each PK variable.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
636826|NCT02529995|Primary|CL/F of AZD9291 After Single Dosing|Rate and extent of absorption of single dose AZD9291 by assessment of apparent clearance following oral administration|PK blood samples are collected at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 120 hours post-dose|Pharmacokinetic population - all patients who received at least 1 dose of AZD9291 and had at least 1 quantifiable plasma concentration collected post-dose without important protocol deviations/violations. Overall number of participants analyzed is the number of patients in Pharmacokinetic population who had available data for each PK variable.||L/h||Standard Deviation|Mean
636827|NCT02529995|Primary|AUC of AZ7550 After Single Dosing|Pharmacokinetics of AZD9291 metabolites (AZ7550) after single dosing by assessment of area under the plasma concentration time curve from zero to infinity|PK blood samples are collected at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 120 hours post-dose|Pharmacokinetic population - all patients who received at least 1 dose of AZD9291 and had at least 1 quantifiable plasma concentration collected post-dose without important protocol deviations/violations. Overall number of participants analyzed is the number of patients in Pharmacokinetic population who had available data for each PK variable.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
636828|NCT02529995|Primary|AUC of AZ5104 After Single Dosing|Pharmacokinetics of AZD9291 metabolites (AZ5104) after single dosing by assessment of area under the plasma concentration time curve from zero to infinity|PK blood samples are collected at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 120 hours post-dose|Pharmacokinetic population - all patients who received at least 1 dose of AZD9291 and had at least 1 quantifiable plasma concentration collected post-dose without important protocol deviations/violations. Overall number of participants analyzed is the number of patients in Pharmacokinetic population who had available data for each PK variable.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
636829|NCT02529995|Primary|AUC of AZD9291 After Single Dosing|Pharmacokinetics of AZD9291 after single dosing by assessment of area under the plasma concentration time curve from zero to infinity|PK blood samples are collected at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 120 hours post-dose|Pharmacokinetic population - all patients who received at least 1 dose of AZD9291 and had at least 1 quantifiable plasma concentration collected post-dose without important protocol deviations/violations. Overall number of participants analyzed is the number of patients in Pharmacokinetic population who had available data for each PK variable.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
636830|NCT02529995|Primary|Cmax of AZ7550 After Single Dosing|Pharmacokinetics of AZD9291 metabolites (AZ7550) after single dosing by assessment of maximum plasma concentration|PK blood samples are collected at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 120 hours post-dose|Pharmacokinetic population - all patients who received at least 1 dose of AZD9291 and had at least 1 quantifiable plasma concentration collected post-dose without important protocol deviations/violations. Overall number of participants analyzed is the number of patients in Pharmacokinetic population who had available data for each PK variable.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
636831|NCT02529995|Primary|Cmax of AZ5104 After Single Dosing|Pharmacokinetics of AZD9291 metabolites (AZ5104) after single dosing by assessment of maximum plasma concentration|PK blood samples are collected at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 120 hours post-dose|Pharmacokinetic population - all patients who received at least 1 dose of AZD9291 and had at least 1 quantifiable plasma concentration collected post-dose without important protocol deviations/violations. Overall number of participants analyzed is the number of patients in Pharmacokinetic population who had available data for each PK variable.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
636832|NCT02529995|Primary|Cmax of AZD9291 After Single Dosing|Pharmacokinetics of AZD9291 after single dosing by assessment of maximum plasma AZD9291 concentration|PK blood samples are collected at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 120 hours post-dose|Pharmacokinetic population - all patients who received at least 1 dose of AZD9291 and had at least 1 quantifiable plasma concentration collected post-dose without important protocol deviations/violations. Overall number of participants analyzed is the number of patients in Pharmacokinetic population who had available data for each PK variable.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
636833|NCT02528721|Primary|Overall Agreement in Determining Presence or Absence of H.Pylori Infection Compared to Biopsy|Overall Agreement of urea breath test with Dual Mode Breath Hp System in accurately detecting presence of H.pylori infection as compared to composite biopsy result|9 months|"According to the FDA Guidelines, if there is a discrepancy between the histology and the rapid urease test results (composite reference standard), the subject is considered unevaluable and thus not included in the analysis."||Percent overall agreement||95% Confidence Interval|Number
640372|NCT02354833|Primary|Median Total Rescue Bolus Dose of Phenylephrine (mcg) to Maintain SBP||At time of surgery, up to 2 hours|||mcg||Full Range|Median
636834|NCT02528721|Primary|Specificity as Described as the Accuracy of the Breath Test in Detecting Absence of H.Pylori Infection Compared to Biopsy|Specificity of urea breath test with Dual Mode Breath Hp System in accurately detecting lack of presence of H.pylori infection as compared to composite biopsy result|9 months|"According to the FDA Guidelines, if there is a discrepancy between the histology and the rapid urease test results (composite reference standard), the subject is considered unevaluable and thus not included in the analysis."||Percent negative agreement||95% Confidence Interval|Number
636835|NCT02528721|Primary|Sensitivity is Described as the Accuracy of the Breath Test in Detecting H.Pylori Infection Compared to Biopsy|Sensitivity of urea breath test with Dual Mode Breath Hp System in accurately detecting presence of H.pylori infection as compared to composite biopsy result|9 months|"According to the FDA Guidelines, if there is a discrepancy between the histology and the rapid urease test results (composite reference standard), the subject is considered unevaluable and thus not included in the analysis."||Percent positive agreement||95% Confidence Interval|Number
636836|NCT02528331|Secondary|Percentage of Adverse Events||6 weeks|||percentage of adverse events|||Number
636837|NCT02528331|Secondary|Partial Response Rate, as Measured by Y-BOCS|Partial response is defined as a reduction of greater than 25%.|6 weeks|||percentage of participants|||Number
636838|NCT02528331|Secondary|Complete Response, as Measured by Y-BOCS|Complete response is defined as a reduction of Y-BOCS score greater than 35%.|6 weeks|||percentage of participants|||Number
636839|NCT02528331|Primary|Remission Rate, as Measured by Y-BOCS|Remission is defined as end-point Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score less than the value of 16.|6 weeks|||percentage of participants|||Number
636840|NCT02528097|Other Pre-specified|Administration of Albumin|The amount of albumin administered to each study participant over the course of the study (time 0 through 72 hours)|Throughout Study (72 hours)||||||
636841|NCT02528097|Secondary|All Cause Mortality||At any point from time 0 through day 3|Outcome data was not collected due to logistical challenges of completing the study.|||||
636842|NCT02528097|Primary|Renal Failure|Primary outcome is the presence of renal failure at any point from the start of the study (time 0) through 72 hours|At any point from time 0 through day 3|Outcome data was not collected due to logistical challenges of completing the study.|||||
636843|NCT02527161|Secondary|Pain|Measured by Visual analogue scale (VAS)|5 years Post-Operatively||||||
636844|NCT02527161|Secondary|Pain|Pain at rest and pain during mobilization was measured using a 10 centimeter Visual analogue scale (VAS). Participants are asked to indicate their level of pain with 0 being no pain and 10 being the worst pain.|2 years Post-Operatively|Participants with available data. Participants = knees. 87 knees had VAS pain during mobilization measurements and 86 knees had VAS pain at rest measurements.||centimeters||Standard Deviation|Mean
636845|NCT02527161|Secondary|Pain|Pain at rest and pain during mobilization was measured using a 10 centimeter Visual analogue scale (VAS). Participants are asked to indicate their level of pain with 0 being no pain and 10 being the worst pain.|12 months Post-Operatively|Participants with available data. Participants=knees.||centimeters||Standard Deviation|Mean
636846|NCT02527161|Secondary|Pain|Pain at rest and pain during mobilization was measured using a 10 centimeter Visual analogue scale (VAS). Participants are asked to indicate their level of pain with 0 being no pain and 10 being the worst pain.|6 months Post-Operatively|Participants with available data. Participants=knees.||centimeters||Standard Deviation|Mean
636847|NCT02527161|Secondary|Short Form-12 Item Health Survey v 2 (SF-12)||5 years Post-Operatively||||||
636848|NCT02527161|Secondary|Short Form-12 Item Health Survey v 2 (SF-12)|The SF-12 Health Survey is a 12 item participant completed questionnaire to measure general health and well-being. It includes a physical and mental status component score: each ranging from 0 to 100 points. Low values represent a poor health state and high values represent a good health state.|2 years Post-Operatively|Participants with available data. Participants=knees.||units on a scale||Standard Deviation|Mean
636849|NCT02527161|Secondary|Short Form-12 Item Health Survey v 2 (SF-12)|The SF-12 Health Survey is a 12 item participant completed questionnaire to measure general health and well-being. It includes a physical and mental status component score: each ranging from 0 to 100 points. Low values represent a poor health state and high values represent a good health state.|12 months Post-Operatively|Participants with available data. Participants=knees.||units on a scale||Standard Deviation|Mean
636850|NCT02527161|Secondary|Short Form-12 Item Health Survey v 2 (SF-12)|The SF-12 Health Survey is a 12 item participant completed questionnaire to measure general health and well-being. It includes a physical and mental status component score: each ranging from 0 to 100 points. Low values represent a poor health state and high values represent a good health state.|6 months Post-Operatively|Participants with available data. Participants = knees.||units on a scale||Standard Deviation|Mean
636851|NCT02527161|Secondary|Knee Injury and Osteoarthritis Score (KOOS)||5 years Post-Operatively||||||
636852|NCT02527161|Secondary|Knee Injury and Osteoarthritis Score (KOOS)|KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.|2 years Post-Operatively|Participants with available data. Participants=knees.||units on a scale||Standard Deviation|Mean
636853|NCT02527161|Secondary|Knee Injury and Osteoarthritis Score (KOOS)|KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.|12 months Post-Operatively|Participants with available data. Participants=knees.||units on a scale||Standard Deviation|Mean
636892|NCT02525536|Primary|Tmax: Time to Reach the Maximum Serum Concentration (Cmax) for AMG 386 After Week 1 Dose|Tmax is the time to reach the maximum serum concentration (Cmax), equal to time (hours) to Cmax.|Week 1: predose, 1, 2, 6, 24, 48 and 96 hours after end of infusion, Week 2: predose|Pharmacokinetic analysis set: all participants who had at least 1 evaluable serum concentrations, received at least 1 dose of AMG 386, and had Week 1 assessment available.||hour (hr)||Full Range|Median
636854|NCT02527161|Secondary|Knee Injury and Osteoarthritis Score (KOOS)|KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.|6 months Post-Operatively|Participants with available data. Participants=knees.||units on a scale||Standard Deviation|Mean
636855|NCT02527161|Secondary|Revision Rate||5 years Post-Operatively||||||
636856|NCT02527161|Secondary|Mechanical Alignment|AnteroPosterior Long Leg X-rays: Alignment measured to mechanical axis at zero degrees.The mechanical axis is defined by lines joining the centre of the femoral head, centre of the knee joint and the centre of the ankle. A negative value = knee varus and a positive value = knee valgus.|12 months Post-Operatively|Participants with available data. Participants=knees.||degrees||Full Range|Mean
636857|NCT02527161|Secondary|Forgotten Joint Score|The Forgotten Joint Score (FJS) is a 12 question form that asks the patient their level of awareness of their artificial joint in 12 scenarios commonly encountered in daily life. Scores can range from 0 to 100 with a higher score indicating a better outcome (high degree of forgetting the joint in everyday life).|5 years Post-Operatively||||||
636858|NCT02527161|Secondary|Forgotten Joint Score|The Forgotten Joint Score (FJS) is a 12 question form that asks the patient their level of awareness of their artificial joint in 12 scenarios commonly encountered in daily life. Scores can range from 0 to 100 with a higher score indicating a better outcome (high degree of forgetting the joint in everyday life).|2 years Post-Operatively|Participants with available data. Participants=knees.||units on a scale||Standard Deviation|Mean
636859|NCT02527161|Secondary|Forgotten Joint Score|The Forgotten Joint Score (FJS) is a 12 question form that asks the patient their level of awareness of their artificial joint in 12 scenarios commonly encountered in daily life. Scores can range from 0 to 100 with a higher score indicating a better outcome (high degree of forgetting the joint in everyday life).|12 months Post-Operatively|Participants with available data. Participants=knees||units on a scale||Standard Deviation|Mean
636860|NCT02527161|Primary|Knee Society Score (KSS)|"The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a minimum score of 0 to a maximum of 100 points. Although the specific scores are not distinguished as excellent, good, fair, or poor, a higher value represents a better outcome."|6 months Post-Operatively|Participants with available data. Participants=knees.||units on a scale||Standard Deviation|Mean
636861|NCT02527161|Primary|Implant Location/Assessment of Alignment|Implant location and limb alignment is assessed using CT scan 3 months after surgery. The mean deviation of the postoperative femoral and tibial alignment from the preoperative plan is measured in degrees.|3 months Post-Operatively|Participants with available data. Participants=knees.||degrees||Standard Deviation|Mean
636862|NCT02527148|Secondary|Oxford Knee Score|To demonstrate, through calculation of Oxford Knee Score (OKS) post operatively, that total knee replacement (TKR) performed using the ShapeMatch® Cutting Guide provides improvement from preoperative levels of patient pain and function comparable to the improvement obtained with TKR performed using computer-assisted Navigation. Oxford Knee Scores will be calculated at 2 years and 5 years post-operatively. The OKS is a participant completed 12 question form on activities of daily living that assess function and pain. Scores can range from 0 to 48 with lower scores indicating a poor outcome and higher scores indicating a more satisfactory joint outcome.|2 and 5 years||||||
636863|NCT02527148|Secondary|Perth CT Protocol|The Perth CT protocol is a comprehensive assessment of total knee replacement (TKR) component position and orientation. The alignment of the TKR components is measured against the mechanical axis and the transepicondylar axis of the lower extremity. The posted data represents the mean angle between the femoral component and mechanical axis of the femur, the angle between tibial component and mechanical axis of the tibia, the tibial component slope relative to the sagittal mechanical axis, and the femoral component rotation relative to surgical epicondylar axis (positive value=external rotation). For all degree values posted a positive (+) value= valgus and a negative (–) value = varus.|3 months|Participants=knees||degrees||Standard Deviation|Mean
636864|NCT02527148|Secondary|The International Knee Society Score (IKSS)|"The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a minimum score of 0 to a maximum of 100 points. Although the specific scores are not distinguished as excellent, good, fair, or poor, a higher value represents a better outcome."|Preoperatively, 6-week, 6-months,12 months, 2 years and 5 years postoperatively||||||
636865|NCT02527148|Secondary|The Forgotten Joint Score (FJS-12)|The Forgotten Joint Score (FJS) is a 12 question form that asks the patient their level of awareness of their artificial joint in 12 scenarios commonly encountered in daily life. Scores can range from 0 to 100 with a higher score indicating a better outcome (high degree of forgetting the joint in everyday life).|6-week, 6-month,12 month visits, 2 years and 5 years||||||
636866|NCT02527148|Secondary|Health-related Quality of Life (EQ-5D-3L)|"The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. The participant is asked to indicate his/her health state by indicating the most appropriate level for each of the 5 dimensions. Responses may be converted into a single summary index by applying a formula that essentially attaches values (also called weights) to each of the levels in each dimension. The index can be calculated by deducting the appropriate weights from 1= the value for full health.
The EQ VAS records the participant’s self-rated health on a vertical, visual analogue scale where the endpoints are labelled from 100 =‘Best imaginable health state’ to 0= ‘Worst imaginable health state’."|Preoperatively, 6-week, 6-month and 12 month visits, 2 years and 5 years||||||
636867|NCT02527148|Secondary|The Western Ontario and McMaster Universities Arthritis Index (WOMAC)|The WOMAC is completed by the participant and measures five items for pain (score range 0-100), two for stiffness (score range 0-100), and 17 for functional limitation (score range 0-100). The total score is the sum of these three categories.|Preoperatively, 6-week, 6-months,12 months, 2 years and 5 years postoperatively||||||
636962|NCT02519387|Secondary|Daily Use of Breakthrough Pain Medication as Measured by Number of Subjects With at Least 1 Day of Breakthrough (Rescue) Pain Medication Usage|Patients will record any other pain medication used in a patient home diary|3 months|||participants|||Number
636869|NCT02527148|Secondary|Cost Effectiveness: Quality-adjusted Life-years (QALYs) From EQ-5D-3L|A quality-adjusted life-year (QALY) takes into account both the quantity and quality of life generated by healthcare interventions. It is the arithmetic product of life expectancy and a measure of the quality of the remaining life-years. A QALY places a weight on time in different health states. A year of perfect health is worth 1 and a year of less than perfect health is worth less than 1. Death is considered to be equivalent to 0; however,some health states may be considered worse than death and have negative scores.|12 months|"Shapematch preoperative N=49, 12 month N=48.
Navigation preoperative N=50, 12 month N-49."||QALY life year||Standard Deviation|Mean
636870|NCT02527148|Secondary|Cost Effectiveness: Length of Stay in Hospital|To compare the cost-effectiveness and cost-utility of the procedure between the ShapeMatch® Cutting Guide group and the computer-assisted Navigation control group the length of stay in number of days spent in the hospital is reported..|14 days|||days||Standard Deviation|Mean
636871|NCT02527148|Secondary|Cost Effectiveness: Cost of Consumable Items Used During Operating Procedure|To compare the cost-effectiveness and cost-utility of the procedure between the ShapeMatch® Cutting Guide group and the computer-assisted Navigation control group. The data for the cost of consumable items used during the operating procedure is not available. Due to limited site resources, a decision was made not to collect this secondary outcome measure data.|Intraoperative - participants were followed for the duration of the operation, an average of 1 hour and 50 minutes.|Cost effectiveness data is not available.|||||
636872|NCT02527148|Secondary|Cost Effectiveness: Wound Length|To compare the cost-effectiveness and cost-utility of the procedure between the ShapeMatch® Cutting Guide group and the computer-assisted Navigation control group the surgical incision length is reported in mm.|Intraoperative - participants were followed for the duration of the operation, an average of 1 hour and 50 minutes.|||millimeters||Standard Deviation|Mean
636873|NCT02527148|Secondary|Cost Effectiveness: Total Duration of Operating Procedure (Anaesthetic Time and Skin-to-skin Incision Time)|Skin to skin time is the time in minutes from initial skin incision to skin closure. Anaesthesia time is the time in minutes that anaesthesia administration is started to the time it is stopped. Data for anaesthesia time is not available due to an error on the original case report form that did not correctly capture anaesthesia time.|Intraoperative - participants were followed for the duration of the operation, an average of 1 hour and 50 minutes.|||minutes||Standard Deviation|Mean
636874|NCT02527148|Primary|Oxford Knee Score|To demonstrate, through calculation of Oxford Knee Score (OKS) post operatively, that total knee replacement (TKR) performed using the ShapeMatch® Cutting Guide provides improvement from preoperative levels of patient pain and function comparable to the improvement obtained with TKR performed using computer-assisted Navigation. Oxford Knee Scores will be calculated pre-operatively and at 6 weeks, 6 months and 12 months. The OKS is a participant completed 12 question form on activities of daily living that assess function and pain. Scores can range from 0 to 48 with lower scores indicating a poor outcome and higher scores indicating a more satisfactory joint outcome.|Preoperatively, 6-week, 6-months,and 12 months postoperatively|"Shapematch: 49 had preoperative and 6 month scores,48 had 6 week and 12 month scores.
Navigation: 50 had preoperative, and 6 month scores, 47 had 6 week, and 37 had 12 month scores
Participants=knees"||units on a scale||Standard Deviation|Mean
636875|NCT02526550|Secondary|Percentage of Number of Participants Reporting Immediate Reactions, Solicited Injection Site and Systemic Reactions, Unsolicited Adverse Events, and Serious Adverse Events Following Vaccination With IMOJEV™|Immediate reactions: any reactions occurred within 30 minutes following vaccination; Solicited injection site reactions: Injection site Pain, Redness, and Swelling; Solicited systemic reactions: Fever (Temperature), Crying/Irritability, Drowsiness, Low Appetite and Skin Rash; Unsolicited adverse events: any adverse events spontaneously reported by participants regardless the causal relationship of adverse events to vaccine; Serious adverse events: Any adverse events that resulted in any of the following outcomes: death, a life threatening adverse event, in patient hospitalization or prolongation of existing hospitalization, a persistent or significant disability / incapacity, a congenital anomaly/birth defect, or any important medical events based upon appropriate medical judgment.|Up to 28 days post booster vaccination|||percentage of participants|||Number
636876|NCT02526550|Secondary|Change From Baseline in Number of Participants With Seroprotection Against Japanese Encephalitis Chimeric Virus at 28 Days Post Vaccination|Immunogenicity was assessed using a Japanese encephalitis chimeric virus (JE-CV) PRNT50 assay. Seroprotection was defined as the percentage of participants with a titer ≥10 (1/dil) at pre-vaccination and at Day 28 post-vaccination.|Day 0 (Baseline) and Day 28 (post-vaccination)|||percentage of participants|||Number
636877|NCT02526550|Primary|Change From Baseline in Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus at 28 Days Post Vaccination|Geometric mean titers were assessed using a Japanese encephalitis chimeric virus (JE-CV) 50% Plaque Reduction Neutralization Test (PRNT50).|Day 0 (Baseline) and Day 28 (post-vaccination)|Per-protocol analysis||titers||95% Confidence Interval|Geometric Mean
636878|NCT02525536|Primary|Accumulation Ratio (AR) for AMG 386|Accumulation ratio (AR) was calculated by dividing the individual AUC (0-tau) value at Week 4 by the corresponding individual AUC (0-tau) value at Week 1.|Week 1: predose, 1, 2, 6, 24, 48 and 96 hours after end of infusion, Week 2: predose, Week 4: predose, 1, 2, 6, 24, 48, 96, and 168 hours after end of infusion|Pharmacokinetic analysis set: all participants who had at least 1 evaluable serum concentrations, received at least 1 dose of AMG 386, and had Week 4 assessment available.||ratio||Standard Deviation|Mean
636879|NCT02525536|Primary|Systemic Clearance at Steady State (CLss) for AMG 386|CL is a quantitative measure of the rate at which a drug substance is removed from the body. Systemic clearance at steady state (CLss) was calculated as the ratio of dose administered to AUC (0 – tau), where AUC (0 – tau) is the area under the serum concentration-time curve during a dosing interval, where tau is the length of the dosing interval (168 hours for once weekly regimen). CLss was normalized to participant’s body weight.|Week 4: predose, 1, 2, 6, 24, 48, 96 and 168 hours after end of infusion|Pharmacokinetic analysis set: all participants who had at least 1 evaluable serum concentrations, received at least 1 dose of AMG 386, and had Week 4 assessment available.||milliliter/hour/kilogram(mL/hr/kg)||Standard Deviation|Mean
636880|NCT02525536|Primary|Terminal Phase Elimination Half-life (T1/2) for AMG 386|Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the serum.|Week 4: predose, 1, 2, 6, 24, 48, 96, 168 and 264 hours after end of infusion|Pharmacokinetic analysis set: all participants who had at least 1 evaluable serum concentrations, received at least 1 dose of AMG 386, and had Week 4 assessment available.||hr||Standard Deviation|Mean
636881|NCT02525536|Primary|Vss: Volume of Distribution at Steady State for AMG 386|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vss is the apparent volume of distribution at steady-state, estimated as: Vss = MRTinf *CLss, where MRTinf is mean residence time of drug extrapolated to infinity and CLss is the systemic clearance at the steady state. Vss was normalized to participant’s body weight.|Week 4: predose, 1, 2, 6, 24, 48, 96, 168 and 264 hours after end of infusion|Pharmacokinetic analysis set: all participants who had at least 1 evaluable serum concentrations, received at least 1 dose of AMG 386, and had Week 4 assessment available.||milliliter per kilogram (mL/kg)||Standard Deviation|Mean
636882|NCT02525536|Primary|Cmin: Minimum Observed Serum Trough Concentration for AMG 386 After Week 4 Dose|Cmin was the observed serum concentration at 168 hours postdose.|Week 4: 168 hours after end of infusion|Pharmacokinetic analysis set: all participants who had at least 1 evaluable serum concentrations, received at least 1 dose of AMG 386, and had Week 4 assessment available.||mcg/mL||Standard Deviation|Mean
636883|NCT02525536|Primary|Cmin: Minimum Observed Serum Trough Concentration for AMG 386 After Week 1 Dose|Cmin was the observed serum concentration at 168 hours postdose.|Week 2: predose|Pharmacokinetic analysis set: all participants who had at least 1 evaluable serum concentrations, received at least 1 dose of AMG 386, and had Week 1 assessment available.||mcg/mL||Standard Deviation|Mean
636884|NCT02525536|Primary|AUC (0-tau): Area Under the Serum Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for AMG 386 After Week 4 Dose|AUC (0-tau) is the area under the serum concentration-time curve during a dosing interval, where tau is the length of the dosing interval (168 hours for once weekly regimen).|Week 4: predose, 1, 2, 6, 24, 48, 96, and 168 hours after end of infusion|Pharmacokinetic analysis set: all participants who had at least 1 evaluable serum concentrations, received at least 1 dose of AMG 386, and had Week 4 assessment available.||mcg*hr/mL||Standard Deviation|Mean
636885|NCT02525536|Primary|AUC (0-tau): Area Under the Serum Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for AMG 386 After Week 1 Dose|AUC (0-tau) is the area under the serum concentration-time curve during a dosing interval, where tau is the length of the dosing interval (168 hours for once weekly regimen).|Week 1: predose, 1, 2, 6, 24, 48 and 96 hours after end of infusion, Week 2: predose|Pharmacokinetic analysis set: all participants who had at least 1 evaluable serum concentrations, received at least 1 dose of AMG 386, and had Week 1 assessment available.||microgram*hour/milliliter (mcg*hr/mL)||Standard Deviation|Mean
636886|NCT02525536|Secondary|Number of Participant With Anti-AMG 386 Antibody|The immunogenicity of AMG 386 was evaluated with an immunoassay that detects anti-AMG 386 binding antibodies. Antibody formation reported at any of the time points was summarized.|Week 1: predose,1,2,6,24,48 and 98 hours after infusion end, Week 3: predose, Week 4: predose, 1,2,6,24,48,96,168 and 264 hours after infusion end, thereafter predose every 4 weeks starting from Week 8 up to 8 weeks after last dose (last dose=Week 249)|Safety analysis set: all participants who received at least 1 dose of AMG 386.||participants|||Number
636887|NCT02525536|Secondary|Percent Change From Baseline to Post-baseline in the Sum of the Longest Diameters of Tumor|The percent change from baseline to post-baseline is the largest percent reduction from baseline among all post-dose measures of the sum of the longest diameter of the tumor burden.|Baseline, assessed every 8 weeks up to 4 weeks after the last dose of study drug, where last dose was given up to Week 249|Response evaluable analysis set: a subset of participants in the FAS with at least 1 measurable lesion at baseline using the RECIST 1.0 and valid post-baseline tumor lesion assessment available. FAS consisted of all participants who had evaluable data and received at least 1 dose of AMG 386.||percent change||Standard Deviation|Mean
636888|NCT02525536|Secondary|Time to Progression (TTP)|TTP is defined as the time from the date of first administration of study treatment to the date of first documentation of PD or death caused by progression. For participants who did not have a documented PD or died owing to causes other than progression, TTP was censored at the time of last response assessment. PD is defined as at least 20% increase in the sum of the longest diameter of target lesions, taking as reference the baseline smallest sum of longest diameter or appearance of 1 or more new lesions or unequivocal progression of existing non-target lesions.|Baseline, assessed every 8 weeks up to 4 weeks after the last dose of study drug, where last dose was given up to Week 249|Response evaluable analysis set: a subset of participants in the FAS with at least 1 measurable lesion at baseline using the RECIST 1.0. FAS consisted of all participants who had evaluable data and received at least 1 dose of AMG386.||Days||Full Range|Median
636889|NCT02525536|Secondary|Percentage of Participants With Objective Response|Objective response rate defined as the rate of participants with CR or PR based on RECIST 1.0 criteria. CR: disappearance of all target lesions, non-target lesions and normalization of tumor marker level. PR: at least 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter.|Baseline, assessed every 8 weeks up to 4 weeks after the last dose of study drug, where last dose was given up to Week 249|Response evaluable analysis set: a subset of participants in the FAS with at least 1 measurable lesion at baseline using the RECIST 1.0. FAS consisted of all participants who had evaluable data and received at least 1 dose of AMG 386.||Percentage of participants||95% Confidence Interval|Number
636890|NCT02525536|Secondary|Number of Participants With Best Overall Response|Best overall response for a participant is the best observed post-baseline disease response as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 criteria. Complete Response (CR): disappearance of all target lesions, non-target lesions and normalization of tumor marker level. Partial Response (PR): at least 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the baseline smallest sum of longest diameter; persistence of 1 or more non-target lesion(s) or maintenance of tumor marker level above the normal limits. PD: at least 20% increase in the sum of the longest diameter of target lesions, taking as reference the baseline smallest sum of longest diameter or appearance of 1 or more new lesions or unequivocal progression of existing non-target lesions.|Baseline, assessed every 8 weeks up to 4 weeks after the last dose of study drug, where last dose was given up to Week 249|Response evaluable analysis set: a subset of participants in the full analysis set (FAS) with at least 1 measurable lesion at baseline using the RECIST 1.0. FAS consisted of all participants who had evaluable data and received at least 1 dose of AMG 386.||participants|||Number
636894|NCT02525536|Primary|Cmax: Maximum Observed Serum Concentration for AMG 386 After Week 1 Dose|Maximum observed serum concentration (Cmax) is the peak serum concentration of a drug after administration, obtained directly from the serum concentration-time curve.|Week 1: predose, 1, 2, 6, 24, 48 and 96 hours after end of infusion, Week 2: predose|Pharmacokinetic analysis set: all participants who had at least 1 evaluable serum concentrations, received at least 1 dose of AMG 386, and had Week 1 assessment available.||microgram per milliliter (mcg/mL)||Standard Deviation|Mean
636895|NCT02525536|Primary|Number of Participants With Abnormal Laboratory Values|The number of participants with any abnormal standard safety laboratory values collected throughout study. Parameters assessed were hematology, chemistry, coagulation and urinalysis. Abnormal laboratory values observed at any time point was summarized and reported.|Week 1: predose, 24, 48 and 96 hours after infusion end, Week 2 and 3: predose, Week 4: predose and 1 hour after infusion end, thereafter every 4 weeks starting from Week 8 up to 4 weeks after the last dose of study drug (last dose=Week 249)|Safety analysis set: all participants who received at least 1 dose of AMG 386.||participants|||Number
636896|NCT02525536|Primary|Number of Participants With Clinically Significant Change From Baseline in Vital Signs|Vital signs included body temperature, diastolic and systolic blood pressure, and pulse (beats per minutes). clinically significant change in vital signs observed at any time point was summarized and reported.|Week 1: predose, 1, 2, 6, 24, 48 and 96 hours after infusion end, Week 2, 3, 4: predose and 1 hour after infusion end, thereafter predose of every 4 weeks starting from Week 8 up to 4 weeks after the last dose of study drug (last dose=Week 249)|Safety analysis set: all participants who received at least 1 dose of AMG 386.||participants|||Number
636897|NCT02525536|Primary|Number of Participants With Significant Change From Baseline in Electrocardiogram (ECG)|Change relative to baseline in electrocardiogram measured throughout study. Significant change in ECG observed at any time point was summarized and reported.|Week 1: predose, 1, 6 hours after end of infusion, Week 4: predose, 1 hour after end of infusion, Week 8, 16: predose, thereafter predose of every 8 weeks up to 4 weeks after the last dose of study drug, where last dose was given up to Week 249|Safety analysis set: all participants who received at least 1 dose of AMG 386.||participants|||Number
636898|NCT02525536|Primary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (AEs) and Serious Adverse Event (SAEs)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. Treatment emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event.|Baseline up to 4 weeks after the last dose of study drug, where last dose was given up to Week 249|Safety analysis set: all participants who received at least 1 dose of AMG 386.||participants|||Number
636899|NCT02525536|Primary|Number of Participants With Dose Limiting Toxicity (DLT)|DLT is defined as any treatment-related, grade 4 or higher hematologic or grade 3 or higher non-hematologic toxicity (according to the Common Terminology Criteria for Adverse Events [CTCAE] version 3.0; hematologic toxicity means any toxicities which are categorized in blood/bone marrow category of CTCAE), except for aspartate aminotransferase (AST), alanine aminotransferase (ALT) and infusion reaction, occurred during the first 28 days after the initial administration (before examination on Study Day 29). DLT also includes AST or ALT: >10*upper limit of normal (ULN) international units per liter (IU/L).|Day 1 up to Day 28|DLT analysis set: all participants who experience at least 1 DLT in the first 28 days of treatment, or who received all planned AMG 386 dose and are followed until the day before the treatment on Study Day 29.||participants|||Number
636900|NCT02524665|Secondary|Percentage of Participant Who Improved by at Least One Grade on the ISGA|During each study visit, investigators/expert grader evaluated the acne severity of participants' faces using the ISGA scale on right and left side of face on a five point scale from 0 to 4 defined as 0-clear, 1-almost clear, 2-mild, 3-moderate, 4-severe. Percent change from Baseline to scheduled time point was calculated as the value at scheduled time point minus the value at Baseline divided by the Baseline value multiplied by 100. Baseline is defined as value at Day 1.|Up to Week 8|ITT analysis set. Only those participants with data available at the indicated time points were analyzed.||Percentage of participants|||Number
636901|NCT02524665|Secondary|Change in Participant Assessment of Tolerability (Redness, Dryness, Burning, Itching and Scaling) From Baseline to Weeks 1, 2, 4 and 8.|Redness, dryness, burning, itching and scaling were evaluated independently by the participant on a five point scale from 0 to 4 defined as 0-none, 1-very minimal, 2-mild, 3-moderate, 4-severe. Change from Baseline to scheduled time point was calculated as the value at scheduled time point minus the value at Baseline. Baseline is defined as value at Day 1.|Baseline and Week 1, 2, 4, 8|ITT analysis set. Only those participants with data available at the indicated time points were analyzed.||Score on a scale||Standard Deviation|Mean
636902|NCT02524665|Secondary|Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8.|Erythema (redness), dryness, and peeling, were evaluated independently by the investigator on a five point scale from 0 to 4 defined as 0-none, 1-very minimal, 2-mild, 3-moderate, 4-severe. Change from Baseline to scheduled time point was calculated as the value at scheduled time point minus the value at Baseline. Baseline is defined as value at Day 1.|Baseline and Week 1, 2, 4, 8|ITT analysis set. Only those participants with data available at the indicated time points were analyzed.||Score on a scale||Standard Deviation|Mean
636903|NCT02524665|Secondary|Mean Change in Investigator's Static Global Assessment (ISGA) From Baseline to Week 1, 2, 4 and 8|During each study visit, investigators/expert grader evaluated the acne severity of participants' faces using the ISGA scale on right and left side of face on a five point scale from 0 to 4 defined as 0-clear, 1-almost clear, 2-mild, 3-moderate, 4-severe. Change from Baseline to scheduled time point was calculated as the value at scheduled time point minus the value at Baseline. Baseline is defined as value at Day 1.|Baseline and Week 1, 2, 4, 8|ITT analysis set. Only those participants available at the indicated time points were analyzed.||Score on a scale||Standard Deviation|Mean
670354|NCT01701505|Secondary|Systolic Blood Pressure||At Baseline, 12 minutes, and 120 minutes|||mmHg||Standard Deviation|Mean
636904|NCT02524665|Secondary|Mean Percent Change in Inflammatory, Non-inflammatory and Total Lesion Counts From Baseline to Week 1, 2 and 4.|During each study visit, expert grader (blinded evaluator) assessed the left side and right side of the face as inflammatory (papules [solid elevation of skin with no visible fluid] and pustules [small inflamed elevation of the skin that is filled with pus]) and non-inflammatory (open comedones [blackheads] and closed comedones [whiteheads]) and total lesions for each participant. Each type of lesion was counted separately; the lesion counts were taken from the face from hairline to the mandible (including forehead, cheeks, and chin). Total lesion counts were calculated as the sum of the inflammatory and non-inflammatory lesion counts. Percent change from Baseline to scheduled time point was calculated as the value at scheduled time point minus the value at Baseline divided by the Baseline value multiplied by 100. Baseline is defined as value at Day 1.|Baseline and Week 1, 2, 4|ITT analysis set. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles).||Percent change||Standard Deviation|Mean
636905|NCT02524665|Primary|Mean Percent Change in Inflammatory, Non-inflammatory and Total Lesion Counts From Baseline to Week 8.|During each study visit, expert grader (blinded evaluator) assessed the left side and right side of the face as inflammatory (papules [solid elevation of skin with no visible fluid] and pustules [small inflamed elevation of the skin that is filled with pus]) and non-inflammatory (open [blackheads] and closed [whiteheads] comedones) and total lesions for each participant. Each type of lesion was counted separately; the lesion counts were taken from the face from hairline to the mandible (including forehead, cheeks, and chin). Total lesion counts were calculated as the sum of the inflammatory and non-inflammatory lesion counts. Percent change from Baseline to Week 8 was calculated as the value at Week 8 minus the value at Baseline divided by the Baseline value multiplied by 100. Baseline is defined as value at Day 1.|Baseline and Week 8|Intent-to-treat (ITT) analysis set was used which included data from all randomized participants who received study product. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles).||Percent change||Standard Deviation|Mean
636906|NCT02524561|Secondary|Abnormal Mammogram/Biopsy|Abnormal mammogram requiring additional imaging modality such as MRI or ultrasound, or a breast biopsy. Information obtained from mammography reports.|baseline to 3 years|Women with mammography reports||Participants|||Count of Participants
636907|NCT02524561|Primary|BIRADS Breast Density|Frequency of the BIRADS category 3-4 years after randomization. BIRADS is a 1-4 category of breast density as assessed by a radiologist. 1= most fatty and least dense, while 4=most dense.|Latest (Year 3 of 4)|Women with mammograms 3-4 years after randomization||participants|||Number
636908|NCT02524561|Primary|BIRADS Breast Density|Frequency of the BIRADS category 1 year after randomization. BIRADS is a 1-4 category of breast density as assessed by a radiologist. 1= most fatty and least dense, while 4=most dense.|Year 1|Women with mammograms 1 year after randomization||participants|||Number
636909|NCT02524561|Primary|BIRADS Breast Density|Breast density prior to randomization. Frequency of the BIRADS category according to randomization status. BIRADS is a 1-4 category of breast density as assessed by a radiologist. 1= most fatty and least dense, while 4=most dense.|Baseline (Prior to Randomization)|Women with mammograms are included.||participants|||Number
636910|NCT02524418|Secondary|Number of Participants With Successful Removal of the Biliary or Pancreas Stones|The successful removal of the biliary or pancreas stones will be determined by the need for additional procedures.|Day 1|Spyglass-guided stone therapy was attempted in 26 patients with biliary stones||participants|||Number
636911|NCT02524418|Secondary|Spybite Sampling Attempts Per Procedure|The mean number of attempts per procedure|Day 1|Of the 70 Cholangioscopy participants in the study only 44 participants had non-stone lithotripsy-related indications. Spyglass sampling was attempted in 36 procedures.||sampling attempts per procedure|Number of procedures analyzed|Full Range|Mean
636912|NCT02524418|Secondary|Strictures Found During the Procedure Will be Measured|The abnormalities found during the procedure, such as strictures.|Day 1|A total of 78 Cholangioscopic examinations were attempted||strictures found|attempted Cholangioscopic exams||Number
636913|NCT02524418|Secondary|Number of Cholangioscopic Exams That Detected Ductal Stones|The abnormalities found during the procedure, such as ductal stones.|Day 1|There were a total of 78 Cholangioscopic examinations in the 70 subjects in this study; 35 exam found stones. Where as in the Pancreatoscopy arm 5 participants were evaluated with only 3 exams being evaluable..||exams|total number of exams||Number
636914|NCT02524418|Secondary|Measurement in Minutes for Spyglass DS Therapeutic Maneuvers|The time it takes to perform the therapeutic maneuvers with the SpyGlass DS in cases sampling was attempted measured in minutes.|approximately 2 hours|For the 75 participants in the study, 83 procedures were completed. Of the 83 procedures, sampling was attempted on 37 procedures in 27 participants.||minutes|Number of Procedures analyzed|Full Range|Mean
636915|NCT02524418|Secondary|Measurement in Minutes for Spyglass DS Diagnostic Maneuvers|The time it takes to perform the diagnostic maneuvers with the SpyGlass DS measured in minutes.|approximately 2 hours|83 Spyglass procedures were performed on the 75 participants||minutes|number of Spyglass Proceudres|Full Range|Mean
636916|NCT02524418|Secondary|Measurement of Total Procedure Time Using the Spyglass DS|Time in minutes will be calculated for completing the procedure with the Spyglass DS.|approximately 2 hours|83 Spyglass procedures were conducted on the 75 participants||minutes|number of Spyglass procedures|Full Range|Mean
636917|NCT02524418|Secondary|Time to Set-up the Spyglass DS for the Procedure|The time it takes to set up the Spyglass DS and related equipment for the procedure.|approximately 2 hours|In 20 procedures, the Spyglass equipment set up was done after ERCP started and this time was recorded. The Investigators did not record the set up time for the other procedures.||minutes||Full Range|Mean
636918|NCT02524418|Primary|Number of Participants With Procedure Technical Success|The performance of the Spyglass DS during the endoscopy will be based on the ability to reach the target site, obtain samples, and to deliver therapeutic intervention.|Day 1|Five of the subjects had both Cholangioscopy and Pancreatoscopy. The results of these procedures were recorded and analyzed separately||participants|||Number
636975|NCT02516098|Primary|AUC Time Zero to Times of Last Quantifiable Concentration (AUC 0-t)|Area under the concentration-time curve of hyoscine butylbromide in plasma over the time interval from 0 to the last quantifiable data point (AUC0-t).|Blood sampling within 2 hours prior to dosing, and 30, 60, and 120 minutes, and at 2.5, 3, 3.5, 3.75, 4, 4.25, 4.5, 5, 5.5, 6, 8, 12, 24, 36, 48 and 60 hours thereafter|PK population||hour (h)*pg/mL||Geometric Coefficient of Variation|Geometric Mean
636919|NCT02524288|Primary|Number of Participants Who Discontinued Treatment Due to a Drug-related AE|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the Sponsor’s product, is also an AE. An investigator who is a qualified physician determined whether an AE is drug-related.|From insertion of the first vaginal ring up to and including 14 days after removal of the last vaginal ring (up to approximately 1 year)|All randomized participants in whom at least 1 vaginal ring was inserted.||Participants|||Number
636920|NCT02524288|Primary|Number of Participants With One or More Drug-related AEs|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the Sponsor’s product, is also an AE. An investigator who is a qualified physician determined whether an AE is drug-related.|From insertion of the first vaginal ring up to and including 14 days after removal of the last vaginal ring (up to approximately 1 year)|All randomized participants in whom at least 1 vaginal ring was inserted.||Participants|||Number
636921|NCT02524288|Primary|Number of Participants Who Discontinued Treatment Due to an AE|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the Sponsor’s product, is also an AE.|From insertion of the first vaginal ring up to and including 14 days after removal of the last vaginal ring (up to approximately 1 year)|All randomized participants in whom at least 1 vaginal ring was inserted.||Participants|||Number
636922|NCT02524288|Primary|Number of Participants With One or More Adverse Events (AEs)|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the Sponsor’s product, is also an AE.|From insertion of the first vaginal ring up to and including 14 days after removal of the last vaginal ring (up to approximately 1 year)|All randomized participants in whom at least 1 vaginal ring was inserted.||Participants|||Number
636923|NCT02524288|Primary|Number of In-Treatment Pregnancies Per 100 Woman-Years of Exposure in Participants 18-35 Years of Age (Pearl Index)|The Pearl Index is the number of in-treatment pregnancies with a conception date in any of the in-treatment cycles, divided by all treatment cycles in each participant from the first treatment cycle to the last treatment cycle (due either to discontinuation or completion), regardless of whether a treatment cycle was “at risk” or not. One woman-year is defined as 13 treatment cycles x 28 days. These efficacy results should be interpreted with caution. Due to the discontinuation of product development and early trial termination, the number of “at risk” treatment cycles in the denominator is based on uncleaned diary data.|Up to 1 year (13 28-day cycles)|All participants assigned to treatment who inserted at least 1 ENG-E2 ring, and who had at least 1 “at risk” treatment cycle, or participants with a treatment cycle (at risk or not) in which a pregnancy had occurred (i.e., treatment cycle containing an estimated conception date for a pregnancy).||Pregnancies per 100 woman years|||Number
637048|NCT02512393|Primary|Short Physical Performance Battery (SPPB)|This is a group of measures that combines the results of the gait speed, chair stand, and balance tests. The score ranges from 0 (worst performance) to 12 (best performance).|baseline|||units on a scale||Standard Deviation|Mean
671886|NCT01680666|Primary|Success of Central Venous Cannulation at First Attempt.||April 2008-September 2011|||participants|||Number
636976|NCT02516098|Primary|Maximum Observed Plasma Concentration of Hyoscine Butylbromide (Cmax)|The maximum measured concentration of hyoscine butylbromide in plasma.|Blood sampling within 2 hours prior to dosing, and 30, 60, and 120 minutes, and at 2.5, 3, 3.5, 3.75, 4, 4.25, 4.5, 5, 5.5, 6, 8, 12, 24, 36, 48 and 60 hours thereafter|All subjects who had evaluable pharmacokinetic (PK) data for at least one of the treatment periods were included in the PK population.||picogram (pg)/millilitre (mL)||Geometric Coefficient of Variation|Geometric Mean
636941|NCT02522624|Secondary|Intended Choice Metal Level|Participants indicated the plan they would choose that day. We categorized plans by governmental classifications of metal level (catastrophic, bronze, silver, gold).|Completed immediately after reviewing Decision Aid tool, taking about 5 minutes to complete.|Intended plan choice metal level data were not available for 2 participants in SMHP (Show Me My Health Plans decision aid) condition (n=162) and for 11 participants in healthcare.gov (Control) condition (n=152)||participants|||Number
636942|NCT02522624|Secondary|Improvements in HILM 2 (Health Insurance Literacy Measure)|Assessed confidence understanding terms.Improvement in HILM was defined as moving from “not confident” pre-intervention to “a little confident” or “very confident” post-intervention, or from “a little confident” pre-intervention to “very confident” post-intervention.|Pre-intervention and post-intervention|One participant in healthcare.gov (Control) condition did not finish HILM (n=162)||participants|||Number
636943|NCT02522624|Secondary|Improvements in HILM 1 (Health Insurance Literacy Measure)|Assessed confidence estimating costs of care.Improvement in HILM was defined as moving from “not confident” pre-intervention to “a little confident” or “very confident” post-intervention, or from “a little confident” pre-intervention to “very confident” post-intervention.|Pre-intervention and post-intervention|One participant in healthcare.gov (Control) condition did not finish HILM (n=162)||participants|||Number
636944|NCT02522624|Primary|Confidence in Choice|The 4-item SURE (Sure of myself; Understand information; Risk-benefit ratio; Encouragement) decisional conflict scale assessed confidence in plan choice. Each item could be answered dichotomously (1=yes; 0=no). Responses were summed and a group average was obtained. Higher SURE values indicate more confidence in choice.|Completed immediately after reviewing Decision Aid tool, taking about 5 minutes to complete.|||units on a scale||Standard Deviation|Mean
636945|NCT02522624|Primary|Decision Self-efficacy|The decision self-efficacy (DSE) scale measured participants' perceived ability to understand insurance info and resist unwanted decision pressure. The 6 items on the DSE scale were each rated on a 3-point scale (0=Not confident; 2=A little confident; 4=Very confident). The sum of the DSE items was divided by 6 and multiplied by 25 to obtain a score on a 0-100 scale. Higher values indicate more confidence in one’s decision-making ability.|Completed immediately after reviewing Decision Aid tool, taking about 5 minutes to complete.|||units on a scale||Standard Deviation|Mean
636946|NCT02522624|Primary|Knowledge Score (% Correct)|8 questions developed in researchers' past work. Assessed health insurance knowledge.|Completed immediately after reviewing Decision Aid tool, taking about 5 minutes to complete.|||percentage of 8 items correctly answered||Standard Deviation|Mean
636947|NCT02520414|Primary|Safety Profile of the Symphion® Bipolar Hysteroscopic Tissue Resection System When Used in the Office Setting for the Removal of Intracavitary Polyps and Myomas.|Absence of device related adverse events, or death.|2 weeks|||percentage of participants|||Number
636948|NCT02519855|Primary|Geometric Mean Titers of B-Victoria-specific Influenza Virus Antibody|Antibodies to B-Victoria-specific influenza virus hemagglutinin were measured using a Hemagglutinin Inhibition (HAI) assay. Antibody titers are the reciprocal of the highest dilution of serum that completely inhibited hemagglutinin.|Baseline and 4 weeks after Influenza vaccination (Week 4)|Participants who met the inclusion criteria, were not protocol violators in a way that could influence the participant's immune response to study vaccine, received the quadrivalent influenza vaccine and ZOSTAVAX™ within the specified day ranges, and had samples for serology obtained within the specified day ranges.||Titer||95% Confidence Interval|Geometric Mean
636977|NCT02515994|Secondary|Average Wear Time|Average Wear time was recorded for each subject at each follow-up visit 1-, 2-, 4-, 8- and 12- weeks. The average wear time across all visits was reported.|3 month Follow-up|Subjects that completed all study visits without a major protocol deviation.||Hours per day||Standard Deviation|Mean
640373|NCT02354833|Primary|Median Total Rescue Bolus Dose of Ephedrine (mg) to Maintain SBP||At time of surgery, up to 2 hours|||mg||Full Range|Median
636949|NCT02519855|Primary|Geometric Mean Titers of B-Yamagata-specific Influenza Virus Antibody|Antibodies to B-Yamagata-specific influenza virus hemagglutinin were measured using a Hemagglutinin Inhibition (HAI) assay. Antibody titers are the reciprocal of the highest dilution of serum that completely inhibited hemagglutinin.|Baseline and 4 weeks after Influenza vaccination (Week 4)|Participants who met the inclusion criteria, were not protocol violators in a way that could influence the participant's immune response to study vaccine, received the quadrivalent influenza vaccine and ZOSTAVAX™ within the specified day ranges, and had samples for serology obtained within the specified day ranges.||Titer||95% Confidence Interval|Geometric Mean
636950|NCT02519855|Primary|Geometric Mean Titers of H3N2-specific Influenza Virus Antibody|Antibodies to H3N2-specific influenza virus hemagglutinin were measured using a Hemagglutinin Inhibition (HAI) assay. Antibody titers are the reciprocal of the highest dilution of serum that completely inhibited hemagglutinin.|Baseline and 4 weeks after Influenza vaccination (Week 4)|Participants who met the inclusion criteria, were not protocol violators in a way that could influence the participant's immune response to study vaccine, received the quadrivalent influenza vaccine and ZOSTAVAX™ within the specified day ranges, and had samples for serology obtained within the specified day ranges.||Titer||95% Confidence Interval|Geometric Mean
636951|NCT02519855|Primary|Geometric Mean Titers of H1N1-specific Influenza Virus Antibody|Antibodies to H1N1-specific influenza virus hemagglutinin were measured using a Hemagglutinin Inhibition (HAI) assay. Antibody titers are the reciprocal of the highest dilution of serum that completely inhibited hemagglutinin.|Baseline and 4 weeks after Influenza vaccination (Week 4)|Participants who met the inclusion criteria, were not protocol violators in a way that could influence the participant's immune response to study vaccine, received the quadrivalent influenza vaccine and ZOSTAVAX™ within the specified day ranges, and had samples for serology obtained within the specified day ranges.||Titer||95% Confidence Interval|Geometric Mean
636952|NCT02519855|Primary|Geometric Mean Fold Rise From Baseline in VZV gpELISA Antibody Titers|Anti-VZV antibodies were determined using a Glycoprotein Enzyme-linked Immunosorbent Assay. Baseline was Day 1 for the Concomitant group and Week 4 for the Nonconcomitant group.|Baseline and 4 weeks after ZOSTAVAX™ vaccination (Week 4 for Concomitant group and Week 8 for Nonconcomitant group)|Participants who met the inclusion criteria, were not protocol violators in a way that could influence the participant's immune response to study vaccine, received the quadrivalent influenza vaccine and ZOSTAVAX™ within the specified day ranges, and had samples for serology obtained within the specified day ranges.||Ratio of titers (Week 4 / Baseline)||95% Confidence Interval|Geometric Mean
636953|NCT02519855|Primary|Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Antibody|Anti-VZV antibodies were determined using a Glycoprotein Enzyme-linked Immunosorbent Assay. Baseline was Day 1 for the Concomitant group and Week 4 for the Nonconcomitant group.|Baseline and 4 weeks after ZOSTAVAX™ vaccination (Week 4 for Concomitant group and Week 8 for Nonconcomitant group)|Participants who met the inclusion criteria, were not protocol violators in a way that could influence the participant's immune response to study vaccine, received the quadrivalent influenza vaccine and ZOSTAVAX™ within the specified day ranges, and had samples for serology obtained within the specified day ranges.||gpELISA units/mL||95% Confidence Interval|Geometric Mean
636954|NCT02519595|Secondary|Sedation Satisfaction|Consultants will be asked to rate their level of satisfaction with sedation on a Likert Scale of 1-3|At the end of the procedure. Approximately 1 hour|consultant satisfaction missing in 6 participants||participants|||Number
636955|NCT02519595|Secondary|Adverse Events|Adverse events secondary to sedation experienced by the patient and interventions performed to overcome them|Patients will be assessed after administration of medication until discharge and will have a follow up phone call 48 hours after discharge for 3 attempts. 5 days.,|||participants|||Number
636956|NCT02519595|Secondary|Additional Dose|Number of participants to whom additional doses of ketamine administered apart from the study dose|Patients will be assessed during procedure . Approximately 1 hours|||participants|||Number
636957|NCT02519595|Secondary|Sedation Duration|Length of sedation was defined as the time duration from the administration of study medication until ready for discharge using standardized discharge criteria (Aldrete scoring >9) followed at our institution.|Patients will be assessed during the length of time from administration of sedation medication until ready for discharge, Approximately 3 hours|||Minutes||Inter-Quartile Range|Median
636958|NCT02519595|Primary|Pain|"Measure pain using self reported Wong Baker faces pain rating scale prior to sedation, during sedation and prior to discharge.The scale shows a series of faces ranging from a happy face at 0, No hurt to a crying face at 10 Hurts worst. The patient must choose the face that best describes how they are feeling. The score has values of 0(no hurt), 2(hurts little bit), 4(hurts little more), 6(hurts even more), 8(hurts whole lot),10 (hurts worst). The patient chooses one number that describes the pain best (eg. Either a 2 or 4)."|Patients will be assessed during the procedure after administration of sedation medicaiton. Approximately 30 minutes|||units on a scale||Inter-Quartile Range|Median
636959|NCT02519595|Primary|Sedation Efficacy|Measure sedation depth using Ramsay Sedation Scale. Varies from 1-6 with 1: anxious, agitated, restless 2: Cooperative, oriented, tranquil 3: responsive to commands 4: Brisk response to light glabellar tap or auditory stimulus 5: Sluggish response to light glabellar tap or loud auditory stimulus 6 being no response to light glabellar tap or loud auditory stimulus. Higher the score, greater is the depth of sedation. Use of ketamine usually provides a depth of sedation of 5 or 6.|Participants will be assessed after study drug adminsitration and the maximum depth of sedation achieved recorded. Approximately 2 hours|||units on a scale||Inter-Quartile Range|Median
636960|NCT02519387|Secondary|Tolerability of Buprenorphine Patch Determined by Number of Patients Who Withdrew From the Study Due to Adverse Events||3 months|This is the intent-to-treat population.||participants|||Number
636961|NCT02519387|Secondary|Physicians’ and Patients’ Treatment Satisfaction of Buprenorphine Patch Usage Assessed Using Physician's Global Impression of Change Scale and Patient's Global Impression of Change Scale Respectively|"The overall assessment of the change in pain intensity from baseline is measured at Visit 6.
Physician's Global Impression of Change scale: Investigator's opinion on a scale of 1 to 7 where 1 is very much improved and 7 is very much worse Patient's Global Impression of Change scale: Subject's opinion on a scale of 1 to 7 where 1 is very much improved and 7 is very much worse"|3 months|||units on a scale||Standard Deviation|Mean
640374|NCT02354833|Secondary|Percentage of Participants Experiencing Both Nausea and Emesis||At time of surgery, up to 2 hours|||percentage of participants||95% Confidence Interval|Number
636963|NCT02519387|Secondary|Change in Sleep Quality as Determined by the 8-item Global Sleep Quality Assessment (GSQA)|"Subjects will evaluate the degree of their sleep disturbance due to pain and improvement in quality of sleep using the GSQA questionnaire comprising of 8 questions, at baseline (Visit 1) and Visit 6 (3 months from baseline visit).
The scores at baseline and Visit 6 are calculated for the following 8 items with scores of:
Trouble falling asleep due to pain -- on a scale of 0 to 10 where 0 is never and 10 is always
Need for pain medication to sleep -- as above
Need for sleep medication to sleep -- as above
Awakened by pain at night -- as above
Awakened by pain in the morning -- as above
Pain affecting partner's sleep -- as above
Rate own sleep quality -- on a scale of 1 to 5 where 1 is very good and 5 is very poor
Number of hours of sleep per night in last 7 days"|Baseline, 3 months|||units on a scale||Standard Deviation|Mean
636964|NCT02519387|Primary|Change in Box Scale-11 (BS-11) Pain Score|"The BS-11 (Box score-11) pain score was the main efficacy outcome measured in this study. The scores at baseline (Visit 1) and Visit 6 (3 months from baseline visit) are reported.
BS-11 is an 11-point scale measuring pain intensity. It ranges from 0 to 10, whereby 0 represents no pain and 10 represents the worst imaginable pain. Subjects selected a number based on the pain intensity they were feeling at that time."|Baseline,3 months|These patients were eligible and included in the intent-to-treat efficacy population.||units on a scale||Standard Deviation|Mean
636965|NCT02518048|Secondary|Change in Total Skin Thickness and Echo-poor Band Thickness From Baseline to EoT|"Skin thickness ultrasound measurements of the test sites were performed at Baseline and End of Treatment.
Two skin parameters were calculated using ultrasound:
The mean total skin thickness
The mean echo-poor band thickness"|Baseline to End of Treatment|||millimeters||Standard Deviation|Mean
636966|NCT02518048|Secondary|Change in Score of Erythema, Scaling, and Infiltration at Individual Visits|"The investigator assessed the severity of the clinical signs erythema, scaling, and infiltration for each test site by using a 7-point scale with half-mark values from 0 (no evidence) to 3.0 (severe).
Erythema: 0 (no evidence - normal skin color) to 3 (severe - intense red). Scaling: 0 (no evidence - no scaling) to 3 (severe - coarse, thick scales). Infiltration: 0 (no evidence - no infiltration) to 3 (severe - very marked infiltration)."|Day 1 (Baseline) to Day 29|||units on a scale||Standard Deviation|Mean
636967|NCT02518048|Secondary|Change in TCS at Individual Visits||Day 1 (Baseline) to Day 29|||units on a scale||Standard Deviation|Mean
636968|NCT02518048|Primary|Absolute Change in Total Clinical Score (TCS) of Clinical Signs (Sum of Erythema, Scaling, Infiltration) Absolute Change in Total Clinical Score (TCS) of Clinical Signs (Sum of Erythema, Scaling, and Infiltration) at End of Treatment Compared to Baseline|"The investigator assessed the severity of the clinical signs erythema, scaling, and infiltration for each test site by using a 7-point scale with half-mark values from 0 (no evidence) to 3.0 (severe).
The total TCS was calculated for each test site by summing the scores for erythema, scaling, and infiltration for that particular test site.
Each test site was assessed at Baseline and on Days 4, 8, 11, 15, 18, 22, 25, and 29 (EoT).
The mean TCS at Baseline was 6.6 for both groups."|Day 1 (Baseline) to Day 29|||units on a scale||Standard Deviation|Mean
636969|NCT02516306|Primary|Ocular Comfort Assessment Following Instillation at Baseline and the Day Prior to Each Study Visit|"Ocular comfort was assessed at Baseline (Day 1) and following the last dose on the day prior to each office visit. Comfort was assessed by each subject marking a visual analog scale labeled 0 (Very Comfortable), 5 (Comfortable) and 10 (Very Comfortable) immediately following instillation of their assigned study product to one eye (Baseline) or both eyes (Days 8 - 91). A small number indicated better comfort. No formal inferential statistics hypotheses were tested."|Baseline, Day 7, Day 14, Day 30, Day 60, Day 90|Includes all subjects who completed the study: EV06 Ophthalmic Solution (49 of 50) and Placebo Ophthalmic Solution (23 of 25)||units on a scale||Standard Deviation|Mean
636970|NCT02516163|Primary|Repeatability of Cutting Guide Position|Repeatability of cutting guide position on the distal femur and proximal tibia assessed by repeated measures using computer navigation system for total knee replacement, assessed intra-operatively. Placement of the cutting guides by the surgeon was determined by recording the position of the cutting guide when placed by the same surgeon multiple times. The intraclass correlation coefficient (ICC) was calculated for each positioning parameter. This included femoral and tibial varus/valgus,flexion/extension, medial resection, lateral resection and rotation. ICC agreement categories:>0.75 excellent agreement; 0.75-0.4 good or fair agreement; <0.4 poor agreement.|Intraoperative - participants were followed for the duration of the operation, an average of 1 hour and 50 minutes.|||intraclass correlation coefficient (ICC)|Participants|95% Confidence Interval|Number
636971|NCT02516150|Secondary|Maximum Change in GIR (Glucose Infusion Rate) From Baseline|This outcome is measuring the maximum change in the glucose infusion rate from the GIR at the time of the injection through the 90 minutes after the glucagon injection in the presence and absence of ethanol. The glucose infusion rate is adjusted up to every two minutes throughout the clamp, and for 90 minutes total after the glucagon injection.|1 Day Visit (approximately 8 to 11 hours)|||ml/hour||Standard Deviation|Mean
636972|NCT02516150|Primary|AOCGIR (Area Over the Curve for Glucose Infusion Rate)|Area over the curve for the glucose infusion rate in the hour following a subcutaneous glucagon dose with a blood alcohol content of 0 vs 0.1%|1 Day Visit (approximately 8 to 11 hours)|||mg*minute/dl||Standard Deviation|Mean
636973|NCT02516098|Secondary|Area Under the Curve, for the Test Product, to the Time of the Maximum Concentration of the Reference Product and the Test Product (AUCReftmax)|Area under the concentration-time curve of hyoscine butylbromide to the time of the maximum concentration of hyoscine butylbromide of the reference product (Buscopan®). This was calculated both for test and reference products.|Blood sampling within 2 hours prior to dosing, and 30, 60, and 120 minutes, and at 2.5, 3, 3.5, 3.75, 4, 4.25, 4.5, 5, 5.5, 6, 8, 12, 24, 36, 48 and 60 hours thereafter|PK population||h*pg/mL||Geometric Coefficient of Variation|Geometric Mean
636974|NCT02516098|Secondary|Area Under the Plasma Concentration Versus Time Curve, With Extrapolation to Infinity (AUC0-∞).|The area under the concentration-time curve of hyoscine butylbromide in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).|Blood sampling within 2 hours prior to dosing, and 30, 60, and 120 minutes, and at 2.5, 3, 3.5, 3.75, 4, 4.25, 4.5, 5, 5.5, 6, 8, 12, 24, 36, 48 and 60 hours thereafter|PK population||h*pg/mL||Geometric Coefficient of Variation|Geometric Mean
637072|NCT02510820|Primary|Ease of Use of Solution|Subjective ease of use for Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at 1 week, 2 week, and 4 week follow-up visit. Scale 0-100, 0=very difficult, 100=very easy|1 week, 2 weeks, 4 weeks|||units on a scale||Standard Deviation|Mean
636979|NCT02515994|Primary|Visual Acuity|Monocular best-corrected visual acuity was assessed using a Snellen (ETDRS) on a LogMAR scale at each follow-up visit 1-, 2-, 4-, 8- and 12- weeks for each subject and subject eye. LogMAR visual acuity was evaluated under high luminance high contrast condition. The average visual acuity across all visits was reported.|Up to 3 month Follow-up|Subjects that completed all study visits without a major protocol deviation.||LogMAR|Participants|Standard Deviation|Mean
636980|NCT02515994|Primary|Slit Lamp Findings|Slit Lamp Findings (SLF) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). This was performed on each subject eye at 1-, 2-, 4-, 8- and 12-week follow-up evaluations. The data was then dichotomized into two groups. Those with grade 3 or higher and those with grade 2 or lower. The number of SLF with grade 3 or higher by eye was reported.|Up to 3 Month Follow-up|All subjects that were dispensed a study lens.||Eyes|Participants||Number
636981|NCT02515279|Primary|Percentage of Participants With Sustained Virologic Response 24 (SVR24)|Clinical response to the treatment was measured by qualitative negative polymerase chain reaction (PCR). SVR24 is defined as the percentage of participants with undetectable HCV RNA 24 weeks after completing treatment.|18 months|All participant who were enrolled in the study. N=number of participants evaluable for this measure.||percentage of participants|||Number
636982|NCT02515279|Primary|Percentage of Participants With End of Treatment Response|Clinical response to the treatment was measured by qualitative negative polymerase chain reaction (PCR). A participant was considered to have and end of treatment response if there was undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) after completing treatment. Participants with available PCR results were reported.|12 months|All participants who were enrolled in the study. N (Number of participants analysed)=participants who were evaluable for this measure.||percentage of participants|||Number
636983|NCT02515279|Primary|Percentage of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability or incapacity; and congenital anomaly. Percentage of participants with AEs included participants affected with both SAEs and non-SAEs.|Up to 6 years|All participants who were enrolled in the study.||percentage of participants|||Number
636984|NCT02515045|Secondary|Change From Baseline (Preoperative Exam) in Intraocular Pressure (IOP)||Month 1.|||mmHg||Standard Deviation|Mean
636985|NCT02515045|Secondary|Change From Baseline (Preoperative Exam) in Pachymetry (Corneal Thickness)||Month 1|||Microns||Standard Deviation|Mean
636986|NCT02515045|Primary|Change From Baseline (Preoperative Exam) in Macular Thickness||Month 1.|||Microns||Standard Deviation|Mean
643915|NCT02224820|Secondary|Immunogenicity|Presence of Anti-Drug Antibodies formation in serum throughout a 64 day period|Up to 64 days|||participants|||Number
636994|NCT02513095|Other Pre-specified|Acute Renal Failure|Acute renal failure as measured by increase in serum creatinine; decrease in urine volume|72 hours||||||
636995|NCT02513095|Other Pre-specified|Duration of Hospital Stay|Measure of the length of hospital stay|Up to 72 hours||||||
636996|NCT02513095|Other Pre-specified|Lactate Plasma Level|Changes from baseline in systemic lactate level|72 hour duration of study||||||
636997|NCT02513095|Secondary|Cumulative Incidence of Recovery of Level of Consciousness Defined as a Glasgow Coma Scale (GCS) GCS ≥ 13 Over the Course of the Study|Cumulative incidence of subjects who achieve a GCS of ≥ 13 over the course of the study|Study duration||||||
636998|NCT02513095|Primary|Cumulative Incidence of Recovery of Level of Consciousness Defined as a Glasgow Coma Scale (GCS) GCS ≥ 13|Cumulative incidence of subjects achieving a GCS ≥ 13 at or prior to 90 minutes post-randomization|90 minutes post-randomization|||Participants|||Count of Participants
636999|NCT02512900|Secondary|Number of Participants Positive for Anti-drug Antibodies and With Neutralizing Antibodies for MEDI9929 at Any Visit|Blood samples for immunogenicity assessment included the determination of anti-drug antibodies (ADA) for MEDI9929. The incidence rate of positive serum antibodies to MEDI9929 were presented.|Days 1 (predose), 29, 57 and 85|As-treated Population. Neutralizing antibody was tested only for the positive ADA samples. Combined immunogenicity data is presented for all participants (that is 12 to 17 years of age). n= Number of participants analyzed for this outcome measure at the given time point.||Participants|||Number
637000|NCT02512900|Secondary|Treatment-emergent Adverse Events Related to Electrocardiogram Evaluations|Computerized triplicate 12-lead ECGs as well as Qualitative 12-lead ECGs were obtained during the study. ECG parameters included heart rate, PR, QRS, QT, and corrected QT (QTc) intervals. Number of participants with TEAEs related to ECG after the start of study drug were to be reported.|From the start of study drug administration up to end of follow-up period, assessed up to Day 85|As-treated Population||Participants|||Number
637001|NCT02512900|Secondary|Treatment-emergent Adverse Events Related to Laboratory Parameters|Laboratory evaluations of blood and urine samples were performed, including hematology (white blood cell count with differential, red blood cell count, hematocrit, hemoglobin and platelet count); serum chemistry: calcium, chloride, potassium, sodium, bicarbonate, aspartate transaminase, alanine transaminase, albumin, uric acid, creatinine, total bilirubin, glucose, alkaline phosphatase, blood urea nitrogen, total protein, and gamma glutamyl transferase; and urinalysis (nitrites, protein, glucose, ketones, urine drug screen, blood, and bilirubin). Number of participants with TEAEs related to laboratory evaluations were reported.|From the start of study drug administration up to end of follow-up period, assessed up to Day 85|As-treated Population||Participants|||Number
637002|NCT02512900|Secondary|Treatment-emergent Adverse Events Related to Vital Sign Parameters and Physical Findings|Vital signs (blood pressure, temperature, pulse, and respiratory rate) were performed throughout the study. The TEAEs related to vital signs in participants were reported.|From the start of study drug administration up to end of follow-up period, assessed up to Day 85|As-treated Population||Participants|||Number
637003|NCT02512900|Secondary|Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events|An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious adverse event (SAE) is any AE resulting in any of the following outcomes such as death; initial or prolonged inpatient hospitalization; life-threatening; persistent or significant disability/incapacity; congenital anomaly or birth defect, or is an important medical event that may jeopardize the participant or may require medical intervention to prevent one of the outcomes listed above. A TEAE is defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug. The AEs were summarized using Medical Dictionary for Regulatory Activities version 19.0|From the start of study drug administration up to end of follow-up period, assessed up to Day 85|As-treated Population: All participants who received any treatment of MEDI9929.||Participants|||Number
637004|NCT02512900|Primary|Apparent Steady-state Volume of Distribution (Vss/F)|The PK parameter Vss/F was estimated based on the serum concentrations of MEDI9929. Serum concentrations of MEDI9929 were measured by enzyme-linked immunosorbent assay.|Predose on Day 1 and Day 2, 4, 7, 11, 15, 22, 29, 43, 57 and 85 post-dose.|PK Population||Liter||Standard Deviation|Mean
637005|NCT02512900|Primary|Apparent Clearance (CL/F)|The PK parameter CL/F was estimated based on the serum concentrations of MEDI9929. Serum concentrations of MEDI9929 were measured by enzyme-linked immunosorbent assay.|Predose on Day 1 and Day 2, 4, 7, 11, 15, 22, 29, 43, 57 and 85 post-dose.|PK Population||Liter/day||Standard Deviation|Mean
637006|NCT02512900|Primary|Terminal Phase Elimination Half Life (t1/2,z)|The t½,z is the time measured for the serum drug concentration of MEDI9929 to decrease by one half. The PK parameter was estimated based on the serum concentrations of MEDI9929. Serum concentrations of MEDI9929 were measured by enzyme-linked immunosorbent assay.|Predose on Day 1 and Day 2, 4, 7, 11, 15, 22, 29, 43, 57 and 85 post-dose.|PK Population||Day||Standard Deviation|Mean
637007|NCT02512900|Primary|Time to Reach Cmax (Tmax)|The Tmax is the time to maximum observed serum concentration of MEDI9929. The PK parameter was estimated based on the serum concentrations of MEDI9929. Serum concentrations of MEDI9929 were measured by enzyme-linked immunosorbent assay.|Predose on Day 1 and Day 2, 4, 7, 11, 15, 22, 29, 43, 57 and 85 post-dose.|PK Population||Day||Full Range|Median
637008|NCT02512900|Primary|Dose-normalized Cmax (Cmax/D)|The Cmax/D is the maximum observed concentration post dose normalized by MEDI9929 dose. The PK parameter was estimated based on the serum concentrations of MEDI9929. Serum concentrations of MEDI9929 were measured by enzyme-linked immunosorbent assay.|Predose on Day 1 and Day 2, 4, 7, 11, 15, 22, 29, 43, 57 and 85 post-dose.|PK Population||μg/mL/mg||Standard Deviation|Mean
637009|NCT02512900|Primary|Maximum Observed Serum Concentration (Cmax)|The PK parameter Cmax was estimated based on the serum concentrations of MEDI9929. Serum concentrations of MEDI9929 were measured by enzyme-linked immunosorbent assay.|Predose on Day 1 and Day 2, 4, 7, 11, 15, 22, 29, 43, 57 and 85 post-dose.|PK Population||μg/mL||Standard Deviation|Mean
637010|NCT02512900|Primary|Dose-normalized AUC (0-infinity) (AUC [0 Infinity]/D)|The AUC (0-infinity)/D is the area under concentration-time curve extrapolated to infinity postdose normalized by MEDI9929 dose. The PK parameter was estimated based on the serum concentrations of MEDI9929. Serum concentrations of MEDI9929 were measured by enzyme-linked immunosorbent assay.|Predose on Day 1 and Day 2, 4, 7, 11, 15, 22, 29, 43, 57 and 85 post-dose.|PK Population||μg*day/mL/mg||Standard Deviation|Mean
637011|NCT02512900|Primary|Area Under the Concentration-Time Curve From Zero to Last Observation (AUC [0-t])|The PK parameter AUC (0-t) was estimated based on the serum concentrations of MEDI9929. Serum concentrations of MEDI9929 were measured by enzyme-linked immunosorbent assay.|Predose on Day 1 and Day 2, 4, 7, 11, 15, 22, 29, 43, 57 and 85 post-dose.|PK Population||μg*day/mL||Standard Deviation|Mean
637012|NCT02512900|Primary|Area Under the Concentration-time Curve From Zero to Infinity (AUC [0-infinity])|The pharmacokinetic (PK) parameter AUC (0 to infinity) was estimated based on the serum concentrations of MEDI9929. Serum concentrations of MEDI9929 were measured by enzyme-linked immunosorbent assay.|Predose on Day 1 and Day 2, 4, 7, 11, 15, 22, 29, 43, 57 and 85 post-dose.|PK Population: All participants who received MEDI9929 and have a sufficient number of serum concentration measurements for computing PK parameters.||μg*day/mL||Standard Deviation|Mean
637013|NCT02512783|Secondary|Parental Assessment of Child's Pain on a Visual Analog Scale||Immediately following propofol injection|This data was not collected.|||||
637014|NCT02512783|Primary|Change in FLACC (Face, Legs, Activity, Cry, Consolability) Score|The FLACC scale measures pain in children aged 2m-7y. The scale ranges from 0-10 with 0 being no pain. The total score out of 10 is based on 5 pieces of criteria, and each criteria is scored as either 0, 1, or 2. Scores on individual criteria are summed up to give a total score. Higher values represent a worse outcome of more pain. FLACC scores will be compared pre- and post-propofol induction to assess the change in FLACC score for each arm.|1 minute before propofol induction compared to 1 minute following propofol induction|||units on a scale||Standard Deviation|Mean
637137|NCT02506257|Other Pre-specified|Conjunctival Examination|Change from baseline conjunctival staining at Day 14. Staining with lissamine green was used. The density of staining was graded with the Oxford Score. Score range was between 0-15. An increase in the score after treatment represent a negative outcome|Baseline and Day 14|||scores on a scale||Standard Deviation|Mean
637015|NCT02512679|Secondary|Number of Participants Who Were Disease Progression-Free and Death-Free at 1 Year Post-transplant|Evaluation for engraftment, correction of the disease, transplant related complications and event-free survival and overall survival of the subjects post-transplant was undertaken by standard measures and evaluation of disease with disease-specific testing.|1 yr|Subjects receiving dose level 1 of Cyclophosphamide event free survival post transplant at 100 days was 95% and 90% 1 year.||participants|||Number
637016|NCT02512679|Secondary|Number of Participants Who Developed Graft-Versus-Host-Disease (GVHD) as Determined by the Glucksberg Scale|Clinical evaluation on a daily basis during hospitalization and at each post transplant clinical visit, up to one year, to determine incidence of acute and chronic graft-versus-host disease using Glucksberg grading scale. Acute graft-versus-host disease (aGVHD) develops within the first three months after transplantation and appears as a skin rash, often accompanied by hyperbilirubenemia, abnormal liver enzymes and gastrointestinal symptoms, as diarrhea, nausea and vomiting. Level of aGVHD is graded from 1-4. Chronic GVHD, typically a late complication of Blood and Marrow Transplantation (BMT) characterized by skin changes, sometimes sclerotic changes, with joint contractures, liver function abnormality, gastrointestinal symptoms and sometime other organ involvement such as eyes, lungs, and obliterative bronchiolitis (OB). Chronic GVHD is graded as absent, limited, or extensive.|1 yr|Subjects who received dose level 1 of Cyclophosphamide were revaluated for graft-versus-host disease (GVHD) post transplantation.||participants|||Number
637017|NCT02512679|Primary|Number of Participants Who Developed Severe Mucositis, Veno-occlusive Disease (VOD), Toxicity of the Kidney, Liver, or Gastrointestinal (GI) Tract up to 1 Year Post-transplant|Assessment of conditioning regimen related toxicity was evaluated and documented with daily assessment during hospitalization and post-transplant follow-up up to one year. None of the subjects developed VOD necessitating any therapeutic intervention, severe mucositis, or toxicity of the Kidney, Liver or Gastrointestinal.|1 year|Subjects who received dose level 1 of Cyclophosphamide did not experience veno-occlusive disease, organ failure or severe mucositis.||participants|||Number
637018|NCT02512679|Primary|Number of Participants With Disease Recurrence at 1 Year Post-transplant|assess rate of disease recurrence (“late relapse”) due to autologous recovery of recipient hematopoiesis at one year post-HSCT.|1 year|All subjects who received dose level 1 of Cyclophosphamide did not experience re-occurrence of disease.||participants|||Number
637019|NCT02512679|Primary|Number of Participants With Neutrophil Engraftment (=/>500 Cells/uL) and Platelet Engraftment (>20K Cell/uL) at 30 Days|Absolute Neutrophil Count (ANC) =/>500;(recovery of white cell count - self sustain platelet above 20,000 per cubic milimeter (20K) - evaluation by Chimerism Study (STR or FISH) at day +30|30 days|Subject enrolled and received Dose Level 1 of Cyclophosphamide and engrafted with Absolute Neutrophil Count (ANC) =/>500;(recovery of white cell count - self sustain platelet above 20k - evaluation by Chimerism Study (STR or FISH) at day +30.||participants|||Number
637020|NCT02512393|Secondary|Interleukin 10 (IL-10) Level||day 5|||pg/mL||Standard Deviation|Mean
637021|NCT02512393|Secondary|Interleukin 10 (IL-10) Level||baseline|||pg/mL||Standard Deviation|Mean
637022|NCT02512393|Secondary|Interleukin 6 (IL-6) Level||day 5|||pg/mL||Standard Deviation|Mean
637023|NCT02512393|Secondary|Interleukin 6 (IL-6) Level||baseline|||pg/mL||Standard Deviation|Mean
637024|NCT02512393|Secondary|Tumor Necrosis Factor (TNF) Level||day 5|||pg/mL||Standard Deviation|Mean
637025|NCT02512393|Secondary|Tumor Necrosis Factor (TNF) Level||baseline|||pg/mL||Standard Deviation|Mean
637026|NCT02512393|Secondary|C-reactive Protein (CRP) Level||day 5|||ng/mL||Standard Deviation|Mean
637027|NCT02512393|Secondary|C-reactive Protein (CRP) Level||baseline|||ng/mL||Standard Deviation|Mean
637028|NCT02512393|Secondary|Cortisol Level||day 5|||pg/mL||Standard Deviation|Mean
637029|NCT02512393|Secondary|Cortisol Level||baseline|||pg/mL||Standard Deviation|Mean
637030|NCT02512393|Secondary|Endorphin Level||day 5|||ng/mL||Standard Deviation|Mean
637031|NCT02512393|Other Pre-specified|Pain Attitudes Questionnaire-Revised Will be Compared Between the Two Groups for a Change Between Baseline and Day 5|This is a questionnaire to assess pain attitudes, such as stoicism, using a 5-point scale that ranges from strongly disagree to strongly agree. The higher the scale the more stoic.|Change from baseline and day 5||||||
637032|NCT02512393|Other Pre-specified|Positive and Negative Affect Scale Will be Compared Between the Two Groups for a Change Between Baseline and Day 5|This is a questionnaire using a 5-point scale that ranges from very slightly or not at all to extremely. The lower the scale the negative the affect and the higher the scare the positive the affect.|Change from baseline and day 5||||||
637033|NCT02512393|Other Pre-specified|Coping Strategies Questionnaire-Revised Will be Compared Between the Two Groups for a Change Between Baseline and Day 5|This is a questionnaire to assess pain coping strategies, such as distancing from pain, using a 7-point scale that ranges from never do that to always do that. The higher the scale the greater use.|Change from baseline and day 5||||||
637034|NCT02512393|Other Pre-specified|Safety Questionnaire Will be Compared Between the Two Groups for a Change Between Baseline, 1, 2, 3, 4, and 5 Days.|This is a questionnaire to assess the presence and severity of adverse events such as headache, tingling, itching, and fatigue, on a scale of 0 to 10, with 0 being not at all and 10 being a highest degree.|Change from baseline, 1, 2, 3, 4, and 5 days||||||
637035|NCT02512393|Other Pre-specified|NIH PROMIS-cognition Will be Compared Between the Two Groups for a Change Between Baseline and Day 5|A score of 50 is the average and a score of 60 is better than average. A score of 40 is the worse score.|Change from baseline and day 5||||||
637036|NCT02512393|Secondary|Endorphin Level||baseline|||ng/mL||Standard Deviation|Mean
637037|NCT02512393|Primary|Conditioned Pain Modulation (CPM)|Conditioned pain modulation (CPM) will be done by using a cold pressor procedure on the skin. The measure is scored on a scale, which ranges from zero to infinity. A higher CPM score indicates higher pain inhibition.|day 5|||units on a scale||Standard Deviation|Mean
637038|NCT02512393|Primary|Conditioned Pain Modulation (CPM)|Conditioned pain modulation (CPM) will be done by using a cold pressor procedure on the skin. The measure is scored on a scale, which ranges from zero to infinity. A higher CPM score indicates higher pain inhibition.|baseline|||units on a scale||Standard Deviation|Mean
637039|NCT02512393|Primary|Punctate Mechanical Pain Sensitivity|Quantitative Sensory Testing (QST) by using punctate mechanical pain delivered by a calibrated nylon monofilament.|day 5|||kilopascal (kPa)||Standard Deviation|Mean
637049|NCT02512393|Primary|Six-minute Walk Test|The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway. The lower the score the worse the condition.|day 5|||meters||Standard Deviation|Mean
637050|NCT02512393|Primary|Six-minute Walk Test|The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway. The lower the score the worse the condition.|baseline|||meters||Standard Deviation|Mean
637051|NCT02512393|Primary|Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Affective Pain Subscale|This is a questionnaire to rate the pain intensity and related symptoms on a scale of 0 to 10, with 0 being none and 10 being the worst possible. The higher the score the worse the pain.|day 5|||units on a scale||Standard Deviation|Mean
637052|NCT02512393|Primary|Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Affective Pain Subscale|This is a questionnaire to rate the pain intensity and related symptoms on a scale of 0 to 10, with 0 being none and 10 being the worst possible. The higher the score the worse the pain.|baseline|||units on a scale||Standard Deviation|Mean
637053|NCT02512393|Primary|Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Neuropathic Pain Subscale|This is a questionnaire to rate the pain intensity and related symptoms on a scale of 0 to 10, with 0 being none and 10 being the worst possible. The higher the score the worse the pain.|day 5|||units on a scale||Standard Deviation|Mean
637054|NCT02512393|Primary|Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Neuropathic Pain Subscale|This is a questionnaire to rate the pain intensity and related symptoms on a scale of 0 to 10, with 0 being none and 10 being the worst possible. The higher the score the worse the pain.|baseline|||units on a scale||Standard Deviation|Mean
637055|NCT02512393|Primary|Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Intermittent Pain Subscale|This is a index to rate the activity of pain based on a scale of difficulty: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe, 4 = Extreme. The higher the score, the worse the pain.|day 5|||units on a scale||Standard Deviation|Mean
637056|NCT02512393|Primary|Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Intermittent Pain Subscale|This is a questionnaire to rate the pain intensity and related symptoms on a scale of 0 to 10, with 0 being none and 10 being the worst possible. The higher the score the worse the pain.|baseline|||units on a scale||Standard Deviation|Mean
637057|NCT02512393|Primary|Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Continuous Pain Subscale|This is a questionnaire to rate the pain intensity and related symptoms on a scale of 0 to 10, with 0 being none and 10 being the worst possible. The higher the score the worse the pain.|day 5|||units on a scale||Standard Deviation|Mean
637058|NCT02512393|Primary|Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Continuous Pain Subscale|This is a questionnaire to rate the pain intensity and related symptoms on a scale of 0 to 10, with 0 being none and 10 being the worst possible. The higher the score the worse the pain.|baseline|||units on a scale||Standard Deviation|Mean
637059|NCT02512393|Primary|Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale|This is a index to rate the activity of pain, stiffness, and physical function based on a scale of difficulty: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe, 4 = Extreme; subscales are added up for a summation score. The higher the score, the worse the pain.|day 5|||units on a scale||Standard Deviation|Mean
637060|NCT02512393|Primary|Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale|This is a index to rate the activity of pain, stiffness, and physical function based on a scale of difficulty: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe, 4 = Extreme; subscales are added up for a summation score. The higher the score, the worse the pain.|baseline|||units on a scale||Standard Deviation|Mean
637061|NCT02512393|Primary|Numeric Rating Scale (NRS) for Pain|Numeric Rating Scale for pain is an 101–point scale for patient self-reporting of pain on a scale of 0 to 100, with 0 being no pain at all and 100 being the worst pain imaginable. The higher the score the worse the pain.|day 5|||units on a scale||Standard Deviation|Mean
637062|NCT02512393|Primary|Numeric Rating Scale (NRS) for Pain|Numeric Rating Scale for pain is an 101–point scale for patient self-reporting of pain on a scale of 0 to 100, with 0 being no pain at all and 100 being the worst pain imaginable. The higher the score the worse the pain.|baseline|||units on a scale||Standard Deviation|Mean
637063|NCT02512224|Secondary|Mortality Calculated From Outcome Section From DPC Database at 30 Days||30 days after the start of the procedure|||participants|||Number
637064|NCT02512224|Secondary|Mortality Calculated From Outcome Section From DPC Database at 14 Days||14 days after the start of the procedure|||Participants|||Number
637065|NCT02512224|Secondary|Re-admission 30 Days||re-admission within 30 days of discharge.|||Participants|||Number
637066|NCT02512224|Secondary|Post-procedural Sepsis||the incidence of post-procedural sepsis occurring during hospitalization. Participants will be followed for the duration of hospital stay, an expected median of 3 weeks after procedure.|||Participants|||Number
637067|NCT02512224|Secondary|Post-procedural Pneumonia||the incidence of post-procedural pneumonia occurring during hospitalization. Participants will be followed for the duration of hospital stay, an expected median of 3 weeks after procedure.|||Participants|||Number
637068|NCT02512224|Primary|Mortality Calculated From Outcome Section From DPC Database at 90 Days||90 days after the start of the procedure|||Participants|||Number
637069|NCT02511782|Primary|CXCL10 in Plasma|Plasma was used to assess CXCL10 levels from blood.|At time of GVHD diagnosis.|We did not analyze the plasma collected from patients with chronic skin GVHD; therefore, there is no data to report. We did not analyze all acute GVHD samples for financial reasons.||Plasma CXCL10 picograms/microliters||Standard Error|Mean
637070|NCT02511782|Primary|CXCL10 in Skin|D-sqaume epidermal discs were used to assess CXCL10 levels from skin.|At time of GVHD diagnosis.|We did not analyze all acute GVHD samples for financial reasons.||Skin CXCL10 femtograms/micrograms||Standard Error|Mean
637071|NCT02510820|Primary|Overall Score|Subjective overall scores Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at 1 week, 2 week, and 4 week follow-up visit. Scale 0-100, 0=extremely poor, 100=excellent, highly impressed.|1 week, 2 weeks, 4 weeks|Data not collected as follows: 2 weeks (1 participant) and 4 weeks (1 participant - Synergi, 1 participant - Biotrue).||units on a scale||Standard Deviation|Mean
637073|NCT02510820|Primary|Ease of Lens Removal|Subjective assessment of removal for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week, 2 week, and 4 week follow-up visits. Scale 0-100, 0=unmanageable. lenses impossible to remove, 100=excellent. no problem with lens remove.|1 week, 2 weeks, 4 weeks|The differences in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.||units on a scale||Standard Deviation|Mean
637074|NCT02510820|Primary|Ease of Lens Insertion|Subjective assessment of insertionfor Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week, 2 week, and 4 week follow-up visits. Scale 0-100, 0=unmanageable. lenses impossible to insert, 100=excellent. no problem with lens insertion.|1 week, 2 weeks, 4 weeks|The differences in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.||units on a scale||Standard Deviation|Mean
637075|NCT02510820|Primary|Ocular Redness|Subjective ocular redness of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at 1 week, 2 week, and 4 week follow-up visits. Scale 0-100, 0=extremely poor. intolerable levels of redness, 100=excellent, no redness.|1 week, 2 weeks, 4 weeks|The differences in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.||units on a scale||Standard Deviation|Mean
637076|NCT02510820|Primary|Burning/Stinging|Subjective assessment of burning/stinging for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week, 2 week, and 4 week visit. Scale 0-100, 0=Extreme stinging / burning, 100=No stinging / burning sensation.|1 week, 2 weeks, 4 weeks|||units on a scale||Standard Deviation|Mean
637077|NCT02510820|Primary|Dryness|Subjective assessment of dryness for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week, 2 week, and 4 week visit. Scale 0-100, 0=extremely dry 100=not dry at all.|1 week, 2 weeks, 4 weeks|||units on a scale||Standard Deviation|Mean
637078|NCT02510820|Primary|Vision|Subjective assessment of vision for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 4 week visit. Scale 0-100, 0=extremely poor, intolerable levels of variation in vision, 100=excellent, no variation in vision.|4 weeks|The differences in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.||units on a scale||Standard Deviation|Mean
637079|NCT02510820|Primary|Vision|Subjective assessment of vision for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 2 week visit. Scale 0-100, 0=extremely poor, intolerable levels of variation in vision, 100=excellent, no variation in vision.|2 weeks|The differences in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.||units on a scale||Standard Deviation|Mean
637080|NCT02510820|Primary|Vision|Subjective assessment of vision for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week visit. Scale 0-100, 0=extremely poor, intolerable levels of variation in vision, 100=excellent, no variation in vision.|1 week|The differences in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.||units on a scale||Standard Deviation|Mean
637081|NCT02510820|Primary|Comfort|Subjective comfort for Synergi / comfilcon A combination and Biotrue / comfilcon A combination is assessed at 4 week visit. Scale 0-100, 0=causes pain, cannot be tolerated, 100=excellent, cannot be felt.|4 weeks|The differences in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.||units on a scale||Standard Deviation|Mean
637082|NCT02510820|Primary|Comfort|Subjective comfort for Synergi / comfilcon A combination and Biotrue / comfilcon A combination is assessed at 2 week visit. Scale 0-100, 0=causes pain, cannot be tolerated, 100=excellent, cannot be felt.|2 weeks|The difference in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.||units on a scale||Standard Deviation|Mean
637083|NCT02510820|Primary|Comfort|Subjective comfort for Synergi / comfilcon A combination and Biotrue / comfilcon A combination is assessed at 1 week visit. Scale 0-100, 0=causes pain, cannot be tolerated, 100=excellent, cannot be felt.|1 week|||units on a scale||Standard Deviation|Mean
637084|NCT02510820|Primary|Papillary Conjunctivitis|Papillary conjunctivitis of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at baseline, 1 week, 2 week, and 4 week follow-up visits. Grades 0-4, 0=normal, 4=severe.|Baseline, 1 week, 2 weeks, 4 weeks|The differences in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.||units on a scale||Standard Deviation|Mean
637085|NCT02510820|Primary|Corneal Staining|Corneal staining of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at baseline, 1 week, 2 week, and 4 week follow-up visits. Grades 0-4, 0=none, 4=patch.|Baseline, 1 week, 2 weeks, 4 weeks|The differences in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.||units on a scale||Standard Deviation|Mean
637086|NCT02510820|Primary|Limbal Hyperaemia|Limbal hyperaemia of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at baseline, 1 week, 2 week, and 4 week follow-up visits. Grades 0-4, 0=normal, 4=severe.|Baseline, 1 week, 2 weeks, 4 weeks|The differences in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.||units on a scale||Standard Deviation|Mean
637087|NCT02510820|Primary|Conjunctival Hyperaemia|Conjunctival hyperaemia of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at baseline, 1 week, 2 week, and 4 week follow-up visits. Grades 0-4, 0=normal, 4=severe.|Baseline, 1 week, 2 weeks, 4 weeks|The differences in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.||units on a scale||Standard Deviation|Mean
637116|NCT02507375|Secondary|Terminal Phase Plasma Half-life (t ½) for Pertuzumab (Cycle 2) in the Presence of Erlotinib (at Steady-state) in Patients With NSCLC|Terminal phase plasma half-life (t ½) is the time required to divide the plasma concentration by two after reaching pseudo-equilibrium, rather than the time required to eliminate half the administered dose.|on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion|PK analysis subset with adequate data for this analysis||days||Standard Deviation|Mean
640375|NCT02354833|Primary|Number of Rescue Boluses to Maintain SBP|Number of rescue boluses to maintain the SBP within 100-120% of baseline|At time of surgery, up to 2 hours|||rescue boluses|||Number
637088|NCT02508103|Primary|Amygdala Response to Cognitive-emotional Processing Task During Functional Magnetic Resonance Imaging (fMRI)|"During fMRI scanning, the investigators will assess the effects of intranasal oxytocin (vs. placebo) on amygdala response to cognitive-emotional processing task (Hariri et al., 2006) during the late luteal phase of two consecutive menstrual cycles. Amygdala reactivity was assessed by extracting a contrast of parameter estimate (COPE) for each region (left and right amygdala). Regions were defined using binarized Harvard-Oxford Subcortical Atlas masks. The parameter estimate was the average estimate of all voxels in each region for the task contrast of viewing Faces vs. Shapes. We used neuroimaging software package FSL to calculate and extract these parameter estimates."|1 hour of scanning during the late luteal phase of two consecutive menstrual cycles|||parameter estimate||Standard Deviation|Mean
637089|NCT02508103|Primary|Change in Premenstrual Symptom Severity|The investigators will analyze premenstrual symptom severity ratings during the late luteal phase of two consecutive menstrual cycles to assess the effects of intranasal oxytocin (vs. placebo) on premenstrual symptom severity. Daily premenstrual symptoms were measured using the Daily Record of Severity of Problems (DRSP; Endicott et al., 2006). Across 24 items representing emotional, physical, and behavioral symptoms, participants indicated “the degree to which the problems have been experienced today”: 1—Not at all, 2—Minimal, 3—Mild, 4—Moderate, 5—Severe, or 6—Extreme. For each participant, we calculated a total score by summing all 24 items. We then calculated a mean total score for each condition by averaging all participants total scores in a given condition. Higher scores represent greater symptoms. Range of total score is 24 to 144.|During the late luteal phase of two consecutive menstrual cycles (an average of 3-5 days of treatment)|||units on a scale||Standard Deviation|Mean
637090|NCT02507752|Secondary|Percentage of Participants Achieving a Clinically Important Increase of >=5 Points in the SF-36 Physical and Mental Component Scores at Weeks 12 and 24.|SF- 36 investigates the standard of quality of life through a general health assessment and not specific to a particular disease, age or treatment group. It is a 36-item questionnaire measuring 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Each domain score ranges from 0 (worst) to 100 (best), with higher scores reflecting better health-related functional status. Two summary scale scores were computed based on weighted combinations of the 8 domain scores: the Physical Component Summary and the Mental Component Summary. SF-36 was assessed using the set of observed cases (OC) at each assessment time.|Week 12 and 24|The ITT population included all screened participants who answered at least one SF-36 questionnaire. n = number of participants analyzed for a given component of SF-36.||Percentage||95% Confidence Interval|Number
637091|NCT02507752|Secondary|Percentage of Participants Achieving a Clinically Important Reduction of >= 0.22 Point in HAQ Score at Week 12.|The Health Assessment Questionnaire-Disability Index (HAQ-DI) is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and activities of daily living). Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area). HAQ-DI total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation. The proportion of participants achieving a clinically important reduction of >= 0.22 point in HAQ (disease-specific questionnaire) at Week 24 was evaluated. HAQ was assessed using the set of observed cases (OC) at each assessment time. An improvement of 0.22 units in HAQ-DI was considered to be a clinically significant improvement.|Week 12|The ITT population included all screened participants who answered at least one SF-36 questionnaire.||Percentage||95% Confidence Interval|Number
637092|NCT02507752|Secondary|Change in SF-36 Domain Scores From Screening to Week (Wk) 12 and 24|SF- 36 investigates the standard of quality of life through a general health assessment and not specific to a particular disease, age or treatment group. It is a 36-item questionnaire measuring 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Each domain score ranges from 0 (worst) to 100 (best), with higher scores reflecting better health-related functional status. Two summary scale scores were computed based on weighted combinations of the 8 domain scores: the Physical Component Summary and the Mental Component Summary. SF-36 was assessed using the set of observed cases (OC) at each assessment time.|Baseline, Week 12, Week 24|The ITT population included all screened participants who answered at least one SF-36 questionnaire. n = the number of participants analyzed for a particular domain of SF-36.||scores on a scale||Standard Error|Mean
637093|NCT02507752|Secondary|Change in SF-36 Physical and Mental Component Scores From Screening to Week 12|SF- 36 investigates the standard of quality of life through a general health assessment and not specific to a particular disease, age or treatment group. It is a 36-item questionnaire measuring 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Each domain score ranges from 0 (worst) to 100 (best), with higher scores reflecting better health-related functional status. Two summary scale scores were computed based on weighted combinations of the 8 domain scores: the Physical Component Summary and the Mental Component Summary. SF-36 was assessed using the set of observed cases (OC) at each assessment time.|Baseline, Week 12|The ITT population included all screened participants who answered at least one SF-36 questionnaire. n = the number of participants analyzed for a particular component of SF-36.||scores on a scale||Standard Error|Mean
637094|NCT02507752|Secondary|Change in Pain Scale (100-mm VAS) From Screening to Weeks 12 and 24|Visual Analogue Scale (VAS) is a 100 millimeter (mm) scale. Intensity of pain range: 0 mm=no pain to 100 mm=worst possible pain. Change from Screening=scores at observation minus score at Screening. An increase in score from Screening represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement. The change in pain scale was analyzed for the set of observed cases (OC) at each assessment time.|Baseline, Week 12, Week 24|The ITT population included all screened participants who answered at least one SF-36 questionnaire. n = the number of participants analyzed at the given time point.||Units on a scale||Standard Error|Mean
637117|NCT02507375|Secondary|Time of Cmax (Tmax) for Pertuzumab (Cycle 2) in the Presence of Erlotinib (at Steady-state) in Patients With NSCLC|The time at which maximum concentration (Cmax), which is the maximum (peak) concentration (amount of drug) measurable in blood plasma after a dose is administered, is reached (Tmax).|on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion|PK analysis subset||days||Standard Deviation|Mean
637095|NCT02507752|Secondary|Change in HAQ Score From Screening to Weeks 12 and 24|The Health Assessment Questionnaire-Disability Index (HAQ-DI) is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and activities of daily living). Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area). HAQ-DI total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation. The number of participants achieving a clinically important reduction of >= 0.22 point in HAQ (disease-specific questionnaire) at Week 24 was evaluated. HAQ was assessed using the set of observed cases (OC) at each assessment time. An improvement of 0.22 units in HAQ-DI was considered to be a clinically significant improvement.|Baseline, Week 12, Week 24|The ITT population included all screened participants who answered at least one SF-36 questionnaire. n = the number of participants analyzed at the given time point.||Units on a scale||Standard Error|Mean
637096|NCT02507752|Secondary|Mean Change From Baseline in Patient Global Assessment (100 mm VAS)|The Physician’s Global Assessment of disease activity was assessed using a 0 to 100 mm horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 mm, and is described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as “maximum disease activity” (maximum arthritis disease activity).Change from Baseline = scores at observation minus score at Baseline. An increase in score from Baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Baseline, Week 12, Week 24|The ITT population included all screened participants who answered at least one SF-36 questionnaire. n = the number of participants analyzed at the given time point.||Units on a scale||Standard Error|Mean
637097|NCT02507752|Secondary|Mean Change From Baseline in Disease Activity Score 28 Joints (DAS28) Score|DAS28 is calculated from the number of swollen joints and tender joints using the 28-joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 (minimum score) to 10 (maximum score); higher scores indicated greater affectation due to disease activity. A DAS28 score of less than or equal to (=<) 3.2 = low disease activity, a DAS28 score of >3.2 to 5.1 = moderate to high disease activity.|Baseline, Week 12, Week 24|The ITT population included all screened participants who answered at least one SF-36 questionnaire. n = the number of participants analyzed at the given time point.||Units on a scale||Standard Error|Mean
637098|NCT02507752|Secondary|Mean Change From Baseline in Tender Joint Count (TJC)|A tender joint count is the most specific clinical method to quantify abnormalities in participants with rheumatoid arthritis (RA). It is associated more with the level of pain.|Baseline, Week 12, Week 24|The ITT population included all screened participants who answered at least one SF-36 questionnaire. n = the number of participants analyzed at the given time point.||Number of tender joints||Standard Error|Mean
637099|NCT02507752|Secondary|Mean Change From Baseline in Swollen Joint Count (SJC)|A swollen joint count is the most specific clinical method to quantify abnormalities in participants with rheumatoid arthritis (RA). It reflects the amount of inflamed synovial tissue.|Baseline, Week 12, Week 24|The ITT population included all screened participants who answered at least one SF-36 questionnaire. n = the number of participants analyzed at the given time point.||Number of swollen joints||Standard Error|Mean
637100|NCT02507752|Secondary|Mean Change From Baseline in C-reactive Protein (CRP).|CRP is an inflammation marker. High levels of this protein indicate inflammation in diseases such as Rheumatoid Arthritis.|Baseline, Week 12, Week 24|The ITT population included all screened participants who answered at least one SF-36 questionnaire. n = the number of participants analyzed at the given time point.||mg/L||Standard Error|Mean
637101|NCT02507752|Secondary|Mean Change From Baseline in Erythrocyte Sedimentation Rate (ESR)|Erythrocyte Sedimentation Rate is an acute phase reactant and a measure of inflammation.|Baseline, Week 12, Week 24|The ITT population included all screened participants who answered at least one SF-36 questionnaire. n = the number of participants analyzed at the given time point.||mm/hr||Standard Error|Mean
637102|NCT02507752|Secondary|Number of Participants With Infusion Reactions, Infectious Events and / or Other Adverse Events in the 24 Weeks After the Start of Treatment.|An infusion reaction is defined as an adverse event that occurs during infusion or within 24 hours after infusion of Rituximab. All infectious events, whether considered related or not to Rituximab, were collected for the safety analysis of the study. An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.|Up to 24 Weeks|The ITT population included all screened participants who answered at least one SF-36 questionnaire.||participants|||Number
637103|NCT02507752|Primary|Mean Change From Baseline in the Short-Form (SF-36) Health Survey Physical Component Score and Mental Component Score at Week 24|SF- 36 investigates the standard of quality of life through a general health assessment and not specific to a particular disease, age or treatment group. It is a 36-item questionnaire measuring 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Each domain score ranges from 0 (worst) to 100 (best), with higher scores reflecting better health-related functional status. Two summary scale scores were computed based on weighted combinations of the 8 domain scores: the Physical Component Summary and the Mental Component Summary. SF-36 was assessed using the set of observed cases (OC) at each assessment time.|Baseline and Week 24|The ITT population included all screened participants who answered at least one SF-36 questionnaire. n = number of participants analyzed for a given component of SF-36.||scores on a scale||Standard Error|Mean
637118|NCT02507375|Secondary|Peak Plasma Concentration (Cmax) for Pertuzumab (Cycle 2) in the Presence of Erlotinib (at Steady-state) in Patients With NSCLC|Maximum Observed Plasma Concentration (Cmax), which is the maximum (peak) concentration (amount of drug) measurable in blood plasma after a dose is administered, typically measured in nanograms/milliliter (ng/mL), reported as mg/L.|on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion|Pharmacokinetic analysis subset, defined as all participants from either cohort with adequate data for performing PK analysis||mg/L||Standard Deviation|Mean
638817|NCT02423798|Primary|Consensus Error Grid Analysis of Paired Sensor and Reference Plasma Glucose Values|All analysis performed using the Consensus Error Grid comparing the paired sensor and YSI reference glucose values|4 months|||percentage|||Number
637104|NCT02507752|Primary|Percentage of Participants Achieving an Improvement of at Least 0.22 Units in Health Assessment Questionnaire (HAQ) at Week 24|The Health Assessment Questionnaire-Disability Index (HAQ-DI) is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and activities of daily living). Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area). HAQ-DI total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation. The proportion of participants achieving a clinically important reduction of >= 0.22 point in HAQ (disease-specific questionnaire) at Week 24 was evaluated. HAQ was assessed using the set of observed cases (OC) at each assessment time. An improvement of 0.22 units in HAQ-DI was considered to be a clinically significant improvement.|Week 24|The ITT population included all screened participants who answered at least one SF-36 questionnaire.||Percentage||95% Confidence Interval|Number
637113|NCT02507375|Secondary|Volume of Distribution at Steady-state (Vss) for Pertuzumab (Cycle 2) in the Presence of Erlotinib (at Steady-state) in Patients With NSCLC|Steady-state volume of distribution of a drug is an estimate of drug distribution independent of elimination processes. It is most useful for predicting the plasma concentrations following multiple dosing to a steady-state or pseudo-equilibrium. Vss is proportional to the amount of drug in the body versus the plasma concentration of the drug at steady state (pseudo-equilibrium). It is a calculated measure.|on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion|PK analysis subset||Liters||Standard Deviation|Mean
637114|NCT02507375|Secondary|Clearance (CL) for Pertuzumab (Cycle 2) in the Presence of Erlotinib (at Steady-state) in Patients With NSCLC|A fundamental concept in pharmacokinetics is drug clearance (CL), that is, elimination of drugs from the body. The clearance is simply the ratio of the dose to the area under the curve (AUC), so that the higher the AUC for a given dose, the lower the clearance. If a drug is administered by continuous infusion and a steady state is achieved, the clearance can be estimated from a single measurement of the plasma drug concentration.|on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion|PK subset||L/day||Standard Deviation|Mean
637115|NCT02507375|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC) for Pertuzumab (Cycle 2) in the Presence of Erlotinib (at Steady-state) in Patients With Non-small Cell Lung Cancer (NSCLC)|Bioavailability [AUC(0-t)] is a measure of how much of the drug reaches the person’s bloodstream from time 0 (pre-dose) to a given time point (t) for the body to use. The extent of product bioavailability is estimated by the area under the blood concentration vs time curve. The Area Under the Curve (AUC) is calculated by plotting the drug’s blood levels on a graph at different times during the set period. The area under this curve reflects the amount of drug exposure in the set time period, calculated as hour * nanograms (ng) per milliliter (mL), which equates to mg.day/L. Bioavailability Extrapolated to Infinity [AUC (0-inf)] is a calculated measure of how much of the drug will ever reach the person’s bloodstream for the body to use. AUC (0-inf) stands for the area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (forever). It is obtained from calculating AUC (0-t) plus AUC (t-inf).|on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion|Pharmacokinetic analysis subset with appropriate data available||mg*day/L||Standard Deviation|Mean
637119|NCT02507375|Secondary|Percentage of Participants With a Complete Response or Partial Response at the End of Cycles 1, 2, 3, 4, and 6|Complete and partial responses were determined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. A complete response was defined as the disappearance of all target and non-target lesions. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameter.|From baseline to the end of the study (up to 42 weeks)|||Percentage of participants|||Number
637120|NCT02507375|Secondary|Percentage of Participants Classified as Responders|"Responders are participants who achieved either a complete response or a partial response according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria. RECIST is a set of published rules that define when tumors in cancer patients improve (respond), stay the same (stabilize), or worsen (progress) during treatment."|within 18 weeks|Full analysis set||percentage of participants|||Number
637121|NCT02507375|Primary|Percentage of Participants With Dose Limiting Toxicities (DLTs)|A DLT was defined as: Any non-hematological toxicity ≥ Grade 3 according to the Common Terminology Criteria for Adverse Events, version 3.0, except for fever, chills, and flu-like symptoms, which occurred despite adequate participant management. The following Grade 1-3 toxicities were exempt: Grade 1-3 skin and/or epithelial toxicities consistent with erlotinib single agent therapy, unless they did not respond to treatment or dose reduction or interruption (Grade 4 skin and/or epithelial toxicities were considered to be a DLT); Grade 4 neutropenia occurring for > 7 days; febrile neutropenia which occurred despite adequate participant management; Grade 4 thrombocytopenia or any thrombocytopenia requiring platelet transfusion; and any subjectively intolerable toxicity felt by the investigator to be related to either one of the compounds.|From baseline to end of the study (up to 42 weeks)|||Percentage of participants|||Number
637122|NCT02506881|Secondary|Cl|Serum clearance of of darbepoetin alfa after single sc of iv administration. Blood samples were taken 30, 20, 10, 0 minutes before injection of study drug and then after 12, 24, 36, 72, 96, 144, 336 and 504 hours post-dose.|336 hours (sc) / 72 hours (iv)|Population for pharmacokinetics analysis: patients who received at least one study drug injection.||hours*kg||Inter-Quartile Range|Median
637123|NCT02506881|Secondary|Tmax|Time to achieve maximum serum concentration of darbepoetin alfa after single sc of iv administration|336 hours (sc) / 72 hours (iv)|Population for pharmacokinetics analysis: patients who received at least one study drug injection.||hours||Inter-Quartile Range|Median
637124|NCT02506881|Secondary|T1/2|Serum half-life of darbepoetin alfa after single sc of iv administration. Blood samples were taken 30, 20, 10, 0 minutes before injection of study drug and then after 12, 24, 36, 72, 96, 144, 336 and 504 hours post-dose.|336 hours (sc) / 72 hours (iv)|Population for pharmacokinetics analysis: patients who received at least one study drug injection.||hours||Inter-Quartile Range|Median
637125|NCT02506881|Primary|AC-Emax|"Maximum elevation of absolute reticulocyte count from the baseline from the Moment of Drug Administration Until 504 hours.
Blood samples were taken 30, 20, 10, 0 minutes before injection of study drug and then after 12, 24, 36, 72, 96, 144, 336 and 504 hours post-dose."|504 hours|Population for analysis of pharmacodynamics included patients who received at least one study drug injection.||reticulocytes * 10^9/l||Inter-Quartile Range|Median
637126|NCT02506881|Primary|AUEC|"Area Under Effect Curve (AUEC) of reticulocytes count from the Moment of Drug Administration Until 504 hours.
Blood samples were taken 30, 20, 10, 0 minutes before injection of study drug and then after 12, 24, 36, 72, 96, 144, 336 and 504 hours post-dose."|504 hours|Population for pharmacokinetics analysis included patients who received at least one study drug injection.||(reticulocytes * 10^9/l)*hour||Inter-Quartile Range|Median
637127|NCT02506881|Primary|Cmax|"Maximal concentration of darbepoetin alfa From the Moment of Drug Administration Until 336 (sc administration) or 72 (iv administration) hours.
Blood samples were taken 30, 20, 10, 0 minutes before injection of study drug and then after 12, 24, 36, 72, 96, 144, 336 and 504 hours post-dose."|336 hours (sc) / 72 hours (iv)|Population for pharmacokinetics analysis included patients who received at least one study drug injection.||pg/ml||Inter-Quartile Range|Median
637128|NCT02506881|Primary|AUC|Area Under Concentration-time Curve (AUC) of Darbepoetin Alfa From the Moment of Drug Administration Until 336 (sc administration) or 72 (iv administration) Hours and to Infinity(AUC(0-336)/AUC(0-72) and AUC(0-∞) Respectively Blood samples were taken 30, 20, 10, 0 minutes before injection of study drug and then after 12, 24, 36, 72, 96, 144, 336 and 504 hours post-dose.|336 hours (sc) / 72 hours (iv)|Population for pharmacokinetics analysis: patients who received at least one study drug injection.||(pg/ml)*hour||Inter-Quartile Range|Median
637129|NCT02506309|Other Pre-specified|Number of Participants With Major Postoperative Complications||one year|||participants|||Number
637130|NCT02506309|Other Pre-specified|Number of Participants With Major Perioperative Complications||one month|||participants|||Number
637131|NCT02506309|Secondary|Patient Global Impression of Improvement (PGI-I) Score|"Patient Global Impression of Improvement (PGI-I) score five years after incontinence surgery. The Patient Global Impression of Improvement (PGI-I) is a global index that may be used to rate the response of a condition to a therapy (transition scale). It is a simple, direct, easy to use scale that is intuitively understandable to clinicians
Very much better
Much better
A little better
No change
A little worse
Much worse
Very much worse"|five years||||||
637132|NCT02506309|Secondary|Patient Global Impression of Improvement (PGI-I) Score|"Patient Global Impression of Improvement (PGI-I) score two years after incontinence surgery. The Patient Global Impression of Improvement (PGI-I) is a global index that may be used to rate the response of a condition to a therapy (transition scale). It is a simple, direct, easy to use scale that is intuitively understandable to clinicians
Very much better
Much better
A little better
No change
A little worse
Much worse
Very much worse"|two years||||||
637133|NCT02506309|Secondary|Patient Global Impression of Improvement (PGI-I) Score|"Patient Global Impression of Improvement (PGI-I) score one year after incontinence surgery. The Patient Global Impression of Improvement (PGI-I) is a global index that may be used to rate the response of a condition to a therapy (transition scale). It is a simple, direct, easy to use scale that is intuitively understandable to clinicians
Very much better
Much better
A little better
No change
A little worse
Much worse
Very much worse"|one year|||units on PGI-I scale||Full Range|Mean
637134|NCT02506309|Primary|Percentage of Participants With Negative Cough Stress Test (CST)|Negative cough stress test five years after incontinence surgery|five years||||||
637135|NCT02506309|Primary|Percentage of Participants With Negative Cough Stress Test (CST)|Negative cough stress test two years after incontinence surgery|two years||||||
637139|NCT02506257|Other Pre-specified|Visual Acuity|Change from baseline Visual acuity. Best corrected visual acuity was reported in decimal fraction. A decrease of visual acuity during treatment was considered a negative safety outcome.|Baseline and Day 14|||decimals||Standard Deviation|Mean
637140|NCT02506257|Other Pre-specified|Systolic Blood Pressure|Change from baseline systolic blood pressure|Baseline and Day 14|||mmHg||Standard Deviation|Mean
637141|NCT02506257|Secondary|Plasma Concentration of PHMB||Day14|||micrograms/ml||Standard Deviation|Mean
637142|NCT02506257|Primary|Number of Subjects With Dose-limiting Adverse Events||up to 21 days from date of randomization|||participants|||Number
637143|NCT02504775|Secondary|Time to Reach Maximum Plasma Concentration (Tmax)|Tmax of paracetamol was obtained graphically from the plasma concentration over time profile. Blood samples were taken before the administration of the reference/test product (pre-dose) and at 0.250, 0.333, 0.500, 0.667, 0.833, 1.000, 1.250, 1.500, 1.750, 2.000, 4.000, 6.000, 8.000, 12.000 and 16.000 h after each period.|2 days|One participant had a positive pre-dose sample in the second period of the study, equivalent to 7.74% of their Cmax, therefore, his data was not taken into account in the bioequivalence analysis||Hours (h)||Standard Deviation|Mean
637144|NCT02504775|Primary|Maximum Plasma Concentration (Cmax)|Cmax of paracetamol was obtained graphically from the plasma concentration over time profile. Blood samples were taken before the administration of the reference/test product (pre-dose) and at 0.250, 0.333, 0.500, 0.667, 0.833, 1.000, 1.250, 1.500, 1.750, 2.000, 4.000, 6.000, 8.000, 12.000 and 16.000 h after each period.|2 days|One participant had a positive pre-dose sample in the second period of the study, equivalent to 7.74% of their Cmax, therefore, his data was not taken into account in the bioequivalence analysis||micogram per mililitre (μg/mL)||Standard Deviation|Mean
637145|NCT02504775|Primary|Area Under the Curve From Time Zero Extrapolated to Infinity [AUC(0-inf)]|AUC(0-inf) of paracetamol was calculated using the trapezoidal rule. Blood samples were taken before the administration of the reference/test product (pre-dose) and at 0.250, 0.333, 0.500, 0.667, 0.833, 1.000, 1.250, 1.500, 1.750, 2.000, 4.000, 6.000, 8.000, 12.000 and 16.000 h after each period.|2 days|One participant had a positive pre-dose sample in the second period of the study, equivalent to 7.74% of their Cmax, therefore, his data was not taken into account in the bioequivalence analysis||h*μg/mL||Standard Deviation|Mean
637146|NCT02504775|Primary|Area Under the Curve From Time Zero to Last Sampling Time [AUC(0-t)]|AUC(0-t) of paracetamol was calculated using the trapezoidal rule. Blood samples were taken before the administration of the reference/test product (pre-dose) and at 0.250, 0.333, 0.500, 0.667, 0.833, 1.000, 1.250, 1.500, 1.750, 2.000, 4.000, 6.000, 8.000, 12.000 and 16.000 hours (h) after each period.|2 days|One participant had a positive pre-dose sample in the second period of the study, equivalent to 7.74% of their Cmax, therefore, his data was not taken into account in the bioequivalence analysis||hours*microgram/millilitre (h*μg/mL)||Standard Deviation|Mean
637147|NCT02504723|Secondary|All Adverse Effects|All adverse effects during the study period|Within 6 years|||Participants|||Count of Participants
637148|NCT02504723|Secondary|All Cause Mortality or Liver Transplantation|All cause mortality or liver transplantation during the study period|Within 6 years|||Participants|||Count of Participants
637149|NCT02504723|Secondary|All Upper Gastrointestinal Bleeding|All upper gastrointestinal bleeding during the follow-up period|Within 6 years|||Participants|||Count of Participants
637150|NCT02504723|Primary|Rebleeding From Gastric Varices|Rebleeding from gastric varices during the follow-up period|Within 6 years|||Participants|||Count of Participants
637151|NCT02504502|Secondary|Patient/Provider Communication|Semi-structured interviews with patients after use of the enhanced report|3 and 6 months||||||
637152|NCT02504502|Primary|Satisfaction With Genomic Test Report|3 questions on how helpful various parts of the test report were for parents who opened the enhanced report.|after receipt of enhanced report|"parents who opened the enhanced report per electronic confirmation. For Clinical care then enhanced report N=4 CV; 2NCV - these 2 NCV parents did not answer the survey questions about the report (missing). For routine care with enhanced report first N=9 NCV."||Participants|||Count of Participants
637153|NCT02504320|Primary|Mean AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Febuxostat|AUC∞ is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.|Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose|Participants with valid parameters for Regimen D and at least one of the test regimen were included in the analyses for this outcome measure. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.||ng*hr/mL||Standard Deviation|Mean
637154|NCT02504320|Primary|Mean AUCt: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Febuxostat|AUCt is a measure of total plasma exposure to the drug from time 0 to time of the last quantifiable concentration.|Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose|Participants with valid parameters for Regimen D and at least one of the test regimen were included in the analyses for this outcome measure. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.||ng*hr/mL||Standard Deviation|Mean
637155|NCT02504320|Primary|Mean Cmax: Maximum Observed Plasma Concentration for Febuxostat|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose|Participants with valid parameters for Regimen D and at least one of the test regimen were included in the analyses for this outcome measure. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.||ng/mL||Standard Deviation|Mean
637156|NCT02504073|Primary|Number of Hypotheses Observed|This outcome is a result of the third part of the questionnaire: 1) What Gait Abnormalities do You See? 2) What do You Consider the Main Problem (1 Sentence) 3) What is Your Hypothesis (Max. 3) By consensus the three independent researchers identified and categorised all the listed hypotheses from question number three of the questionnaire. After that the use frequency of each item was analysed globally and for each patient.|up to 2 months|||Number of different hypotheses|||Number
637157|NCT02504073|Primary|Number of Main Problems Observed|This outcome is a result of the second part of the Questionnaire: 1) What Gait Abnormalities do You See? 2) What do You Consider the Main Problem (1 Sentence) 3) What is Your Hypothesis (Max. 3) By consensus the three independent researchers identified the main statements from the sentences written. Items were afterwards categorised. Finally the frequency of each item was analysed globally and for each patient.|up to 2 months|||number of different main problems|||Number
637158|NCT02504073|Primary|Number of Gait Abnormalities Observed|"The questionnaire will be the basis of this study as it will be the basis for open coding. It is handed out to 54 observers (=physiotherapists) and will be filled in 6 times (for 6 patient videos).
The questionnaire consists of 3 main questions:
what gait abnormalities do you see?
What do you consider the main problem (1 sentence)
what is your hypothesis (max. 3) The question one delivers different items (each new observation is a new item) that were determined patient by patient and rater by rater by three independent researchers. They were then listed and categorised by consensus. Finally, the frequency of each item was analysed globally and for each patient."|up to 2 months|||number of different gait abnormalities|||Number
637159|NCT02503982|Primary|Area Under the Curve (AUC)|Valganciclovir area under the curve (AUC) calculated with the trapezoidal method using drug levels measured at 2, 5 and 10 h, and extrapolated beyond the 10 hour time point to arrive at a 24-hour curve.|drug levels measured at 2, 5 and 10 h following administration of the dose on day 4 creating a 24 hours curve|||mcg∙h/mL||Inter-Quartile Range|Median
637160|NCT02503865|Secondary|Immunoassay Cortisole in Blood|Immunoassay Cortisole in the blood (nmole/L) was measured|up to 12 weeks|||nmol/L||Standard Error|Mean
637161|NCT02503865|Secondary|Immunoassay Hormones in Blood|Immunoassay Insulin in the blood (in nU/L) was investigated|up to 12 weeks|||nU/L||Standard Error|Mean
637162|NCT02503865|Secondary|Lipid Profile|Blood sample for lipid profile (Cholesterol in mmole/L, High-density Lipoproteids in mmole/L, Triglycerides in mmole/L) was measured|up to 12 weeks|||mmole/L||Standard Error|Mean
637163|NCT02503865|Primary|Systolic/ Diastolic Blood Pressures (mm Hg)|Systolic and Diastolic Blood Pressures (mm Hg) was measured by manual/automatic tonometery|up to 12 weeks|||mm Hg||Standard Error|Mean
637164|NCT02503865|Primary|Blood Glucose Level|Fasting blood glucose (FBG) (mmole/L) and Two-hour postprandial glucose (THPG) (mmole/L) were measured.|up to 12 weeks|||mmole/L||Standard Error|Mean
637165|NCT02503787|Other Pre-specified|Change in Average Leg Pain as Measured by the Diary-reported Numeric Pain Rating Scale (NPRS) Questionnaire|Self reported daily average leg pain score 5 days prior to baseline and at 3 months post device activation in subjects receiving programming options in spinal cord stimulation. The question is scored 0-10 (0=no pain; 10=pain as bad as can be).|From baseline to 3 months post device activation|||units on a scale||Standard Deviation|Mean
637166|NCT02503787|Other Pre-specified|Change in Average Back Pain as Measured by the Diary-reported Numeric Pain Rating Scale (NPRS) Questionnaire|Self reported daily average back pain score 5 days prior to baseline and at 3 months post device activation in subjects receiving programming options in spinal cord stimulation. The question is scored 0-10 (0=no pain; 10=pain as bad as can be).|From baseline to 3 months post device activation|||units on a scale||Standard Deviation|Mean
637167|NCT02503787|Secondary|Patient Global Impression of Change|Evaluate study subject impression of change as measured by the Patient Global Impression of Change questionnaire. The questionnaire encompasses change in ACTIVITY LIMITATIONS, SYMPTOMS, EMOTIONS, and OVERALL QUALITY OF LIFE, scored on a scale of 1-7 (1=no change or the condition has gotten worse: 7=A great deal better, and a considerable improvement that has made all the difference).|From baseline to 3 months post device activation|||Participants|||Count of Participants
637168|NCT02503787|Primary|Change in Average Overall Pain as Measured by the Diary-reported Numeric Pain Rating Scale (NPRS) Questionnaire|Self reported daily average overall pain score 5 days prior to baseline and at 3 months post device activation in subjects receiving programming options in spinal cord stimulation. The question is scored 0-10 (0=no pain; 10=pain as bad as can be).|From baseline to 3 months post device activation|||units on a scale||Standard Deviation|Mean
637169|NCT02503254|Primary|Levels of Carboxyhemoglobin (COHb)|"% COHb blood measurements performed in the evening of Day 5, expressed as % of saturation of hemoglobin.
Geometric Least Squares means are provided as descriptive statistics."|5 days|"The analysis was performed on the full analysis set (FAS) population: all randomized subjects who had at least 1 post randomization product use experience (CHTP 1.0 or CC) and had at least 1 non-safety assessment.
However, due to sample issues such as clotting, COHb assessment results could not be generated for some of the subjects."||percentage of saturation of hemoglobin||95% Confidence Interval|Least Squares Mean
637170|NCT02503254|Primary|Concentration of S-phenylmercapturic Acid (S-PMA)|"Concentrations measured on Day 5 in urine, adjusted for creatinine.
Geometric Least Squares means are provided as descriptive statistics."|5 days|"The analysis was performed on the full analysis set (FAS) population.
The FAS consisted of all the randomized subjects who had at least 1 post randomization product use experience (CHTP 1.0 or CC) and had at least 1 non-safety assessment."||pg/mg creat||95% Confidence Interval|Least Squares Mean
637171|NCT02503254|Primary|Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA)|"Concentrations measured on Day 5 in urine, adjusted for creatinine.
Geometric Least Squares means are provided as descriptive statistics."|5 days|"The analysis was performed on the full analysis set (FAS) population.
The FAS consisted of all the randomized subjects who had at least 1 post randomization product use experience (CHTP 1.0 or CC) and had at least 1 non-safety assessment."||ng/mg creat||95% Confidence Interval|Least Squares Mean
637172|NCT02503254|Primary|Concentration of Monohydroxybutenyl Mercapturic Acid (MHBMA)|"Concentrations measured on Day 5 in urine, adjusted for creatinine.
Geometric Least Squares (LS) means are provided as descriptive statistics."|5 days|"The analysis was performed on the full analysis set (FAS) population.
The FAS consisted of all the randomized subjects who had at least 1 post randomization product use experience (CHTP 1.0 or CC) and had at least 1 non-safety assessment."||pg/mg creat||95% Confidence Interval|Least Squares Mean
637173|NCT02503215|Secondary|Change in Fluid Distribution From Baseline|Segmental and total body water will be non-invasively assessed before sleeping and after awakening by a bioimpedance device (InBody S10 Analyser™, Biospace, South Korea), which will provide information regarding nighttime fluid shift at baseline and after compression stocking use. The amount of water, expressed in liters, is assessed in both extra and intracellular components.|1 week|"Volume distribution evaluated by bioimpedance analysis evaluated fluid shift from the legs at baseline and after wearing compression stockings. The amount overnight fluid that moved rostrally from the legs is depicted below (results expressed as mean ± standard deviation):
Baseline: 571.4 ± 389.6 ml
Compression stockings: 517.9 ± 452.2 ml"||mililiters||Standard Deviation|Mean
637212|NCT02500368|Secondary|Conjunctival Staining|Conjunctival Staining 5 locations (central, nasal, temporal, superior, inferior): Scale 0-4; 0.5 steps, 0=None,1=Minimal diffuse punctuate, 2=Coalescent punctuate, 3=Confluent, 4=Deep confluent|Baseline and 1 week|||units on a scale||Standard Deviation|Mean
637174|NCT02503215|Secondary|Change of Heart Rate Variability Change From Baseline|Electrocardiogram performed during polysomnography examination will be downloaded to a specific software for heart rate variability assessment (Kubius HRV™, University of Eastern Finland, Finland), which provides spectral assessment of heart rate variability in its both components: low frequency (LF) and high frequency (HF). Patients who present higher LF/HF during the night compared to the beggining of the polysomnography exam have, by definition, increased sympathetic activity during the night. Such evaluation will be accessed in both baseline and after compression stockings use.|1 week|Overnight increase in LF/HF ratio at baseline: 11/12 patients (92%) Overnight increase in LF/HF ratio after compression stockings use: 7/12 patients (58%)||percentage of participants|||Number
637175|NCT02503215|Primary|Change of Obstructive Apnea Severity Index Score From Baseline|"Apnea/Hypopnea index (AIH) was assessed by a validated polysomnography (EMBLA®S4500, Embla Systems Inc., Broomfield, CO, USA) at baseline and 1 week after compression stockings use. The observed results are expressed as median and interquartile range (25,75 percentiles):
AIH at baseline: 20.8 (14.2; 39.6) events/hour;
AIH after compression stockings use: 16.7 (3.5; 28.9) events/hour"|1 week|Apnea/Hypopnea Index||events/hour||Inter-Quartile Range|Median
637176|NCT02502734|Secondary|Number of Participants With Any Adverse Events (AE) and Any Serious Adverse Event (SAE).|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect. Number of participants with AEs and SAEs have been presented. Two participants randomized to Sequence 1 (Placebo/FF), were treated with placebo in Period 1; however, neither received FF in Period 2, due to premature withdrawal.|From the start of study treatment until follow-up (assessed up to 54 days)|ITT Population||Participants|||Number
637177|NCT02502734|Primary|Mean Growth Rate in Lower-leg Growth, as Determined by Knemometry.|Lower leg growth rate was assessed in growth population as change in the lower leg length from start to end of each 2-week period, divided by time interval (number of days) between the two measurements, multiplied by 7. The Growth Population is defined as the Intent-To-Treat (ITT) population excluding participants having any of the following: did not fulfill growth-specific criteria; did not have growth assessment(s) at any defined time point; withdrawal from study due to adverse events related to major trauma to the legs, major surgery, or severe dehydration; received protocol prohibited medications that may affect short term growth, prior to randomization and during the study; protocol deviations defined in exclusion criteria for growth population. ITT Population consists of all randomized participants who received at least one dose of study drug.|Over a two week (14 day) treatment period for FF 50mcg OD and Placebo respectively.|Growth Population||millimeter per week||Standard Deviation|Least Squares Mean
637178|NCT02502487|Secondary|Breath Rate After Withdrawal of Cystoscope||after withdrawal of cystoscope|||times per minute||Standard Deviation|Mean
637179|NCT02502487|Secondary|Breath Rate at Cystoscopic Inspection of External Sphincter||at cystoscopic inspection of external sphincter|||times per minute||Standard Deviation|Mean
637180|NCT02502487|Secondary|Breath Rate at Cystoscopic Inspection of Penile and Bulbar Urthra||at cystoscopic inspection of penile and bulbar Urthra|||times per minute||Standard Deviation|Mean
637181|NCT02502487|Secondary|Breath Rate Before Gel Administration||before gel administration|||times per minute||Standard Deviation|Mean
637182|NCT02502487|Secondary|Oxygen Saturation by Pulse After Withdrawal of Cystoscope||after withdrawal of cystoscope|||percentage||Inter-Quartile Range|Median
637183|NCT02502487|Secondary|Oxygen Saturation by Pulse at Cystoscopic Inspection of External Sphincter||at cystoscopic inspection of external sphincter|||percentage||Inter-Quartile Range|Median
637184|NCT02502487|Secondary|Oxygen Saturation by Pulse at Cystoscopic Inspection of Penile and Bulbar Urthra||at cystoscopic inspection of penile and bulbar urthra|||percentage||Inter-Quartile Range|Median
637185|NCT02502487|Secondary|Oxygen Saturation by Pulse Before Gel Administration||before gel administration|||percentage||Inter-Quartile Range|Median
637186|NCT02502487|Secondary|Mean Arterial Pressure After Withdrawal of Cystoscope||after withdrawal of cystoscope|||mmHg||Standard Deviation|Mean
637187|NCT02502487|Secondary|Mean Arterial Pressure at Cystoscopic Inspection of External Sphincter||at cystoscopic inspection of external sphincter|||mmHg||Standard Deviation|Mean
637188|NCT02502487|Secondary|Mean Arterial Pressure at Cystoscopic Inspection of Penile and Bulbar Urthra||at cystoscopic inspection of penile and bulbar urthra|||mmHg||Standard Deviation|Mean
637189|NCT02502487|Secondary|Mean Arterial Pressure Before Gel Administration||before gel administration|||mmHg||Standard Deviation|Mean
637190|NCT02502487|Secondary|Heart Rate After Withdrawal of Cystoscope||after withdrawal of cystoscope|||Beats per minute||Standard Deviation|Mean
637191|NCT02502487|Secondary|Heart Rate at Cystoscopic Inspection of External Sphincter||at cystoscopic inspection of external sphincter|||Beats per minute||Standard Deviation|Mean
637192|NCT02502487|Secondary|Heart Rate at Cystoscopic Inspection of Penile and Bulbar Urthra||at cystoscopic inspection of penile and bulbar urethra|||Beats per minute||Standard Deviation|Mean
637193|NCT02502487|Secondary|Heart Rate Before Gel Administration||before gel administration|||Beats per minute||Standard Deviation|Mean
637194|NCT02502487|Secondary|Visual Analog Scale (VAS) for Pain|A visual analog scale (VAS) ranging from 0 to 10 was used to assess the patients’ pain during the procedure. 0 means no pain, 1 to 3 means mild pain, 4 to 7 means moderate pain, and 8 to 10 means severe pain. Patients were asked the VAS score to express the degree of pain at each time point.|after withdrawal of cystoscope|||units on a scale||Inter-Quartile Range|Median
637195|NCT02502487|Secondary|Visual Analog Scale (VAS) for Pain|A visual analog scale (VAS) ranging from 0 to 10 was used to assess the patients’ pain during the procedure. 0 means no pain, 1 to 3 means mild pain, 4 to 7 means moderate pain, and 8 to 10 means severe pain. Patients were asked the VAS score to express the degree of pain at each time point.|at cystoscopic inspection of prostate and bladder|||units on a scale||Inter-Quartile Range|Median
637213|NCT02500368|Secondary|Conjunctival Indentation|Conjunctival Indentation 5 locations (central, nasal, temporal, superior, inferior): Scale 0-4, 0.5 steps; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe|Baseline and 1 week.|||units on a scale||Standard Deviation|Mean
637196|NCT02502487|Secondary|Visual Analog Scale (VAS) for Pain|A visual analog scale (VAS) ranging from 0 to 10 was used to assess the patients’ pain during the procedure. 0 means no pain, 1 to 3 means mild pain, 4 to 7 means moderate pain, and 8 to 10 means severe pain. Patients were asked the VAS score to express the degree of pain at each time point.|at cystoscopic inspection of penile and bulbar urethra|||units on a scale||Inter-Quartile Range|Median
637197|NCT02502487|Secondary|Visual Analog Scale (VAS) for Pain|A visual analog scale (VAS) ranging from 0 to 10 was used to assess the patients’ pain during the procedure. 0 means no pain, 1 to 3 means mild pain, 4 to 7 means moderate pain, and 8 to 10 means severe pain. Patients were asked the VAS score to express the degree of pain at each time point.|before gel administration|||units on a scale||Inter-Quartile Range|Median
637198|NCT02502487|Primary|Visual Analog Scale (VAS) for Pain|A visual analog scale (VAS) ranging from 0 to 10 was used to assess the patients’ pain during the procedure. 0 means no pain, 1 to 3 means mild pain, 4 to 7 means moderate pain, and 8 to 10 means severe pain. Patients were asked the VAS score to express the degree of pain at each time point.|at cystoscopic inspection of external sphincter|||units on a scale||Inter-Quartile Range|Median
637199|NCT02501590|Primary|Normilized Muscle Activity|The maximal voluntary contraction (MVC) value for each muscle will be computed as the average of three peaks of the surface electromyography (sEMG) data, which differed by no more than 10% from one another. The mean root mean square (RMS) values of the sEMG data will be normalized by the MVC value for each muscle so that the value is presented by percentage.|day1|||% mvc||Inter-Quartile Range|Median
637200|NCT02500836|Secondary|Immediate and Sustained Anesthetic Success for Cocaine HCl 10% Topical Solution|Subjects who meet the following for each nostril that received the study drug application are considered a treatment success: Prior to the diagnostic procedure or surgery, based on the von Frey monofilament test, after application of the assigned study drug solution (Cocaine HCl 10% Topical Solution), the subject response is a 0 (zero) pain score on the 11 point pain scale (0 = no pain, 10 = unbearable pain) compared to the von Frey monofilament test right before study drug application. And, during the diagnostic procedure or surgery, no further analgesic treatment is required (only 10% Cocaine HCl subjects who receive a diagnostic procedure or surgery).|One Day, Single office based diagnostic procedure or surgery|The analysis of secondary outcome data is based on an intent-to-treat population, which includes all randomized subjects who received study drug. The analysis of this secondary efficacy endpoint includes comparisons to the primary endpoint for the Placebo Topical Solution treatment group.||proportion of participants||95% Confidence Interval|Number
637201|NCT02500836|Primary|Immediate and Sustained Anesthetic Success for Cocaine HCl 4% Topical Solution and Placebo Topical Solution|Subjects who meet the following for each nostril that received the study drug application are considered a treatment success: Prior to the diagnostic procedure or surgery, based on the von Frey monofilament test, after application of the assigned study drug solution (Cocaine HCl 4% Topical Solution or Placebo Topical Solution), the subject response is a 0 (zero) pain score on the 11 point pain scale (0 = no pain, 10 = unbearable pain) compared to the von Frey monofilament test right before study drug application. And, during the diagnostic procedure or surgery, no further analgesic treatment is required (only 4% Cocaine HCl subjects who receive a diagnostic procedure or surgery). Subjects with missing primary outcome data are marked as treatment failures in both treatment groups.|One Day, Single office based diagnostic procedure or surgery|The analysis of primary outcome data is based on an intent-to-treat population, which includes all randomized subjects who received study drug.||proportion of participants||95% Confidence Interval|Number
637202|NCT02500758|Secondary|"Change in the Release of Skin Flora From the Hands From Baseline to 3 Hours After Surgical Scrub Disinfection, Wearing Surgical Gloves (Time Frame- Baseline and 3 Hours)."|Number of colony-forming units (CFU) sampled 3 hours after disinfection by surgical scrubbing using parachlorometaxylenol or clorhexidine digluconate, using surgical gloves. After surgical scrubbing, drying and wearing surgical gloves, the fingertips are rubbed (including that of the thumb) for 1 minute on the base of a Petri dish containing volumes of 1.0 ml and 0.1 ml of undiluted sampling fluid of TSB and 0.1 ml from its 10-1 dilution are plated out for quantitative culture in TSA.|3 hours|||CFU/ml||95% Confidence Interval|Mean
637203|NCT02500758|Primary|"Change in the Release of Skin Flora From the Hands From Baseline to 5 Minutes After Disinfection by Surgical Scrubbing (Time Frame- Baseline and 5 Minutes)."|Number of colony-forming units (CFU) sampled up to 5 minutes after disinfection by surgical scrubbing using parachlorometaxylenol or clorhexidine digluconate. After surgical scrubbing and drying, the fingertips are rubbed (including that of the thumb) for 1 minute on the base of a Petri dish containing volumes of 1.0 ml and 0.1 ml of undiluted sampling fluid of TSB and 0.1 ml from its 10-1 dilution are plated out for quantitative culture in TSA.|5 minutes|||CFU/ml||95% Confidence Interval|Mean
637204|NCT02500537|Secondary|Incidence of Repeat Hospital Admissions for Procedural-related Complications|Incidence of repeat hospital admissions for procedural-related complications for up to 30 days following procedure|30 Days following procedure|||participants|||Number
637205|NCT02500537|Secondary|Staple Line Assessment:|Number of additional intervention(s) to treat staple-line failure|Participants will be followed for the duration of hospital stay, on average up to 5 days post-op|||participants|||Number
637206|NCT02500537|Secondary|Staple Line Assessment: Incidence of Post-operative Infection|Incidence of post-operative infection at the staple line in abdominal patients and thoracic patients|Participants will be followed for the duration of hospital stay, on average up to 5 days|||participants|||Number
637207|NCT02500537|Secondary|Staple Line Assessment: Incidence of Leakage; Post-Op|The incidence of leakage for abdominal procedures; Post-up|Participants will be followed for the duration of hospital stay, on average up to 5 days|Abdominal patients only||participants|||Number
637208|NCT02500537|Secondary|Staple Line Assessment: Duration of Leakage, Post-Op|Duration of leakage based on chest tube drainage in days|Participants will be followed for the duration of hospital stay, on average up to 5 days|Thoracic patients only||days||Standard Deviation|Mean
637209|NCT02500537|Secondary|Staple Line Assessment: Incidence of Leakage|As measured by air leak test, or standard of care, as applicable|Day 0|||incidences of leakage|||Number
637210|NCT02500537|Secondary|Staple Line Assessment: Incidence of Staple Line Bleeding|The incidence of staple line bleeding will be measured as ≥ 50 cc|Day 0|||incidences of staple line bleeding|||Number
637211|NCT02500537|Primary|The Primary Endpoint is the Incidence of Reported Device-related Adverse Events (AEs) Through 30 Days Following Indicated Abdominal or Thoracic Procedures.||Through 30 Days|||Device related adverse events|||Number
637218|NCT02500368|Secondary|Overall Lens Fit|"Overall Lens Fit Scale 0-4, 0.25 steps 0=Very poor (lens should not be worn at all);
Poor (lens could be worn with supervision only);
Fair (would prefer to refit, but clinically acceptable);
Good (fit could be slightly improved);
Very good (optimal)"|Baseline and 1 week|||units on a scale||Standard Deviation|Mean
637219|NCT02500368|Secondary|Ease of Lens Removal|Subjective ratings scale (0-100): 0=Could not remove lens from eye, 20=Frequently takes multiple attempts to remove from eye; often unsuccessful, 40=Frequently takes multiple attempts to remove from eye, 60=Occasionally takes a few attempts to remove from eye, 80=Rarely difficult to remove from eye, 100=Always easy to remove lens from eye.|1 week|||units on a scale||Standard Deviation|Mean
637220|NCT02500368|Secondary|Ease of Lens Insertion|Subjective ratings scale (0-100): 0=Could not place lens on eye, 20=Frequently takes multiple attempts to place on eye; often unsuccessful, 40=Frequently takes multiple attempts to place on eye, 60=Occasionally takes a few attempts to place on eye, 80=Rarely difficult to place on eye, 100=Always easy to place lens on eye|Baseline and 1 week|||units on a scale||Standard Deviation|Mean
637221|NCT02500368|Secondary|Visual Quality|Subjective ratings scale (0-100): 0=Extremely poor vision all of the time; cannot function, 20=Frequently annoying vision problems, 40=Occasionally annoying vision problems, 60=Occasionally noticeable but not annoying vision problems, 80=Rarely noticeable vision problems, 100=Excellent vision all of the time. Different time points were taken for vision quality: lens dispense at baseline, lens insertion at 1 week, and overall at 1 week.|Baseline and 1 week|||units on a scale||Standard Deviation|Mean
637222|NCT02500368|Secondary|Lens Tightness|Lens tightness Scale 0%-100%, 0%=extremely loose fit, 50%=optimal push resistance and smooth return, 100%=no movement.|Baseline and 1 week|||percentage of tightness||Standard Deviation|Mean
637223|NCT02500368|Secondary|Post-blink Movement|Post-blink movement evaluated by estimating the distance the lens was moving immediately after a blink. Primary Gaze: (mm, 0.1 steps)|Baseline and 1 week|||mm steps||Standard Deviation|Mean
637224|NCT02500368|Secondary|Lens Centration|"Lens centration was evaluated by the conjunctival overlap to determine whether lens was slightly or excessively decentered.
(mm, 0.1 steps) N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior T/I - Temporal/Interior"|1 week|||eyes|Eyes||Number
637225|NCT02500368|Secondary|Lens Centration|"Lens centration was evaluated by the conjunctival overlap to determine whether lens was slightly or excessively decentered.
(mm, 0.1 steps) N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior T/I - Temporal/Interior"|Baseline|||eyes|Eyes||Number
637226|NCT02500368|Secondary|Lens Problems|Lenses were evaluated for defects, scratches, fibers, blue specks, and other findings.|Baseline and 1 week|||Lenses|Lenses||Number
637227|NCT02500368|Secondary|Lens Deposition|Lens Deposits Scale 0-4, 0.25 steps. 0=excellent; 4=severely reduced|Baseline and 1 week|||units on a scale||Standard Deviation|Mean
637228|NCT02500368|Secondary|High Contrast Acuity at High Room Illumination|Logarithm of the Minimum Angle or Resolution (LogMAR) Chart|Baseline and 1 week|||LogMAR||Standard Deviation|Mean
637229|NCT02500368|Secondary|Surface Appearance|Grade ratings category (smooth, grainy, or other)|1 week|||Eyes|Eyes||Number
637230|NCT02500368|Secondary|Surface Appearance|Grade ratings category (smooth, grainy, or other)|Baseline|||Eyes|Eyes||Number
637231|NCT02500368|Secondary|Lens Wettability|Grading scale 0-4, 0.25 steps, 0=excellent; 4=severely reduced.|Baseline and 1 week|||units on a scale||Standard Deviation|Mean
637232|NCT02500368|Primary|Dryness|Subjective ratings scale (0-100): 0=Cannot be worn, extremely dry, 20=Frequently Irritating, 40=Occasionally irritating, 60=Occasionally noticeable but not irritating, 80=Rarely noticeable, 100=No dryness experienced at any time. Time points for dryness: lens dispense at baseline, lens insertion at 1 week, and overall at 1 week.|Baseline and 1 week|||units on a scale||Standard Deviation|Mean
637233|NCT02500368|Primary|Comfort|Subjective ratings scale (0-100) assessed: 0=Cannot be worn, causes pain, 20=Frequently irritating, 40=Occasionally irritating, 60=Occasionally noticable but not irritating, 80=Rarely noticeable, 100=Cannot be felt ever. Time points for comfort: lens dispense at baseline, lens insertion at 1 week, and overall at 1 week.|Baseline and 1 week|||units on a scale||Standard Deviation|Mean
637234|NCT02500056|Secondary|Foreign Body Feeling|The question about foreign body feeling was a yes-or-no question|6-month follow-up|Drop-outs at 6-month follow-up (3+6) not included||percentage of patients with foreign body|||Number
637235|NCT02500056|Secondary|Chronic Pain|On visual analogue scale pain measurement at rest, on coughing, when rising from lying to sitting and during physical effort and exercise|3-year follow-up|||percentage of patients with pain|||Number
637236|NCT02500056|Primary|Chronic Pain|On visual analogue scale pain measurement at rest, on coughing, when rising from lying to sitting and during physical effort and exercise|6-month follow-up|||percentage of patients with pain|||Number
637237|NCT02499692|Secondary|Myocardial Infarction (MI, Q-wave and Non–Q-wave) Rate||30 days|||percentage of participants|||Number
637238|NCT02499692|Secondary|Target Vessel Failure (TVF) Rate||30 days|||percentage of participants|||Number
637239|NCT02499692|Secondary|Target Vessel Revascularization (TVR) Rate||30 days|||percentage of participants|||Number
637240|NCT02499692|Secondary|Target Lesion Failure (TLF) Rate||30 days|||percentage of participants|||Number
637241|NCT02499692|Secondary|Target Lesion Revascularization (TLR) Rate||30 days|||percentage of participants|||Number
637242|NCT02499692|Primary|Technical Success Rate|Technical success rate, defined as successful delivery and deployment of the study stent to the target lesion, without balloon rupture or stent embolization, and post-procedure diameter stenosis of <30% assessed in 2 near-orthogonal projections with TIMI 3 flow in the target lesion, as visually assessed by the physician|1 day|||percentage of participants|||Number
637243|NCT02499575|Secondary|Pain Relief Measured by Defense and Veterans Pain Scale|Evaluate patient-reported pain scores (scale of 0 (no pain) - 10 (worst pain)) at 0, 6, 12, 24, 36, 48, 60, and 72 hours following surgery|Through 72 hours post-surgery (0, 6, 12, 24, 36, 48, 60, and 72 hours post-surgery)|||units on scale of 0 -10|||Number
637244|NCT02499575|Primary|Total Opioid Use as Measured by Questionnaire|Compare total opioid use (reported as total morphine equivalents) over 72 hours between groups.|Daily through the third day (72 hours) post-surgery|||morphine equivalents|||Number
643916|NCT02224820|Secondary|Pharmacodynamics|IgG cleavage and regeneration measured by ELISA|Up to day 64|||µg/mL||Standard Deviation|Mean
637246|NCT02498821|Other Pre-specified|Mean Total Procedural Cost From Initiation of Procedure (Opening of PICC Kit) to Catheter Tip Confirmation (Release for IV Therapy)|Cost calculated as follows: mean (sum of material cost per PICC insertion, X-ray cost per PICC insertion, non-interventional radiology (IR) labor cost per PICC insertion, IR labor cost per PICC insertion).|Usually ranges from 0 to 300 minutes|||US dollars||Standard Deviation|Mean
637247|NCT02498821|Other Pre-specified|Nurse Time Associated With Malposition Adjustment After Initial PICC Placement (Per Event)|Nurse time associated with a malposition was defined as the time between when the nurse opened gathered materials for correcting the malposition (e.g., PICC kit, dressing change kit, saline, syringe) and when the subject was released for IV therapy.|Usually ranges from 0 to 30 minutes|||minutes|events|Standard Deviation|Mean
637248|NCT02498821|Other Pre-specified|Nurse Time Associated With Initial PICC Placement (Per Patient)|Nurse time associated with initial PICC placement was defined as the time between when the nurse arrived at the subject and when the nurse left the room, minus the amount of time it took to conduct the research consent with the subject for the study; it includes time spent gathering supplies (before entering the subject’s room) and any consents obtained for the PICC procedure (not study-related consents).|Usually ranges from 0 to 150 minutes|||minutes||Standard Deviation|Mean
637249|NCT02498821|Secondary|Number of Overtime Hours Worked Per PICC Placement Procedure||Measured from initiation to completion of procedure (usually from 0 to 5 hours)|||hours||Standard Deviation|Mean
637250|NCT02498821|Secondary|Number of Lab Draws Missed Due to PICC Not Being Ready for Use||Measured from initiation to completion of procedure (usually from 0 to 300 minutes)|||Lab draws||Standard Deviation|Mean
637251|NCT02498821|Secondary|Number of Medication Doses Missed Due to PICC Not Being Ready for Use||Measured from initiation to completion of procedure (usually from 0 to 300 minutes)|||Doses||Standard Deviation|Mean
637252|NCT02498821|Secondary|Number of Additional Venous Access Devices (VADs) Required Due to PICC Not Being Ready for Use||Measured from initiation to completion of procedure (usually from 0 to 300 minutes)|||Venous Access Devices (VADs)|||Number
637253|NCT02498821|Secondary|Health Care Professional (HCP) Procedural Satisfaction (Overall)|HCPs were asked to rate satisfaction with the procedure (overall) on a scale from 0 to 10 with 0 meaning “not at all satisfied” and 10 meaning “extremely satisfied”.|Measured immediately after the procedure completion (usually ranges from 0 to 300 minutes following procedure initiation).|||units on a scale||Standard Deviation|Mean
637254|NCT02498821|Secondary|Number of Subsequent Malposition Attempts|This is the number of remaining malpositions following the first malposition adjustment attempt. All PICCs were inserted properly after the second malposition adjustment attempt.|Measured from initiation to completion of procedure (usually from 0 to 300 minutes)|||malposition adjustment attempts|||Number
637255|NCT02498821|Secondary|Number of Participants With Malpositions||Measured from initiation to completion of procedure (usually from 0 to 300 minutes)|||Participants|||Count of Participants
637256|NCT02498821|Secondary|Total Number of Chest X-rays Performed Per Subject||Measured from initiation to completion of procedure (usually from 0 to 300 minutes)|||Chest X-rays||Full Range|Mean
637257|NCT02498821|Primary|Time From Initiation of Procedure (Opening of PICC Kit) to Catheter Tip Confirmation (Release for IV Therapy).||Usually ranges from 0 to 300 minutes from initiation of procedure|||minutes||Standard Deviation|Mean
637258|NCT02498678|Secondary|Monitor Settings - Sensitivity|Sensitivity calculated by the monitor calibration, It is a numeric value that ranges from 1 to 512, but there is no measurement unit provided. Using the default CAL 2 function, the TOF-Watch® SX monitor automatically determines the sensitivity for a specific patient. The sensitivity can be adjusted between 1 and 512, where 512 represents the most sensitive setting. A sensitivity setting of 157 is the default value. This value represents how the monitor measures motor response of the patient to electrical stimulation of train of four (TOF). If the patient has intense motor response, the monitor reduces its sensitivity. If the patient has poor motor response, the monitor increase your sensitivity.|An expected average of 60 minutes|||units on a scale from 1 to 512||Standard Deviation|Mean
637259|NCT02498678|Secondary|Monitor Settings - Electric Current|Electric current (milliampere) calculated by the monitor calibration|An expected average of 60 minutes|||milliampere||Standard Deviation|Mean
637260|NCT02498678|Secondary|Time to Obtain T1 Height Stability|Time, in minutes, for the stabilization T1 height (maximum acceptable variation of up to 5%) before administration of neuromuscular blocking agent. According to the guidelines for good clinical research practice in pharmacodynamics studies of neuromuscular blocking agents, the monitor must present a stable response of T1 height (baseline) for a period of 2–5 min before administration of an neuromuscular blocking agents.|An expected average of 60 minutes|||seconds||Standard Deviation|Mean
637261|NCT02498678|Primary|T1 Height|T1 height documentation when train of four reaches 0,9 (90%)|An expected average of 60 minutes|||percentage of T1 height||Standard Deviation|Mean
637262|NCT02498678|Primary|Train of Four 0,9 (90%)|Time to recovery to train of four 0,9 (90%). When the fourth stimulus value (T4) divided by the first stimulus (T1) reaches the ratio of 0.9 (T4 / T1)|An expected average of 60 minutes|||minutes||Standard Deviation|Mean
637263|NCT02498522|Primary|Miscarriage Rate||6 months|||participants||95% Confidence Interval|Number
637264|NCT02497235|Secondary|Percent Change From Baseline in the AUEC24 for Plasma 24S Hydroxycholesterol (24HC)|Percent change was calculated as = [(Postdose AUEC24(2) – Baseline AUEC24(2))/Baseline AUEC24(2)]*100 percent.|Baseline (Day -1): 1 hour and at multiple timepoints (up to 12 hours) post check in and Day 1: pre-dose and at multiple timepoints (up to 24 hours) post-TAK-935 dose|PK set included all participants who received TAK-935 and had at least 1 measurable plasma concentration for either TAK-935 or its M-1 metabolite. Data was reported for Participant 1 and 2 of each of TAK-935 50, 100, 200, and 300 mg arms and Participant 1, 2, and 3 of TAK-935 600 mg arm.||percent change|||Number
637265|NCT02497235|Secondary|Plasma Concentration of TAK-935 During Post-TAK-935 Dosing PET Scan Periods||At time 0 (just after tracer injection), 1 hour after tracer injection and 2 hours after tracer injection for each post-TAK-935 dosing PET scan period|Pharmacokinetic (PK) set included all participants who received TAK-935 and had at least 1 measurable plasma concentration for either TAK-935 or its M-1 metabolite. Data was reported for Participant 1 and 2 of each of TAK-935 50, 100, 200, and 300 mg arms and Participant 1, 2, and 3 of TAK-935 600 mg arm.||nanogram per milliliter (ng/mL)|||Number
645346|NCT02181127|Secondary|Mean Absolute Relative Deviation (MARD) vs. Subset of BG Measurements Before Meals and at Bedtime||2 weeks||||||
637266|NCT02497235|Primary|CH24H Brain Enzyme Occupancy as a Function of TAK-935 Plasma Concentration at 24 Hours Post-TAK-935 Dose|CH24H brain enzyme occupancy was obtained by graphical analysis of global occupancy plot. Global occupancy plot was calculated as: VT (Baseline) - VT (Day 1) = Occupancy (Day 1) * (VT [Baseline] - VND), where VT (Baseline) and VT (Day 1) are the total distribution volumes obtained at Baseline and after TAK-935 administration, respectively and VND is the non-displaceable volume of distribution. The occupancy is determined as the slope of the linear regression of the plot, and the VND as the x-intercept.|24 hours post-TAK-935 dose|PET target occupancy set where 24 hour post-TAK-935-dose assessment were available. PET target occupancy set included all participants who received study drug (TAK-935) and had a technically adequate Baseline PET scan and at least 1 technically adequate post-TAK-935 dose PET scan.||percentage of occupancy|||Number
637267|NCT02497235|Primary|CH24H Brain Enzyme Occupancy as a Function of TAK-935 Plasma Concentration at 10 Hours Post-TAK-935 Dose|CH24H brain enzyme occupancy was obtained by graphical analysis of global occupancy plot. Global occupancy plot was calculated as: VT (Baseline) - VT (Day 1) = Occupancy (Day 1) * (VT [Baseline] - VND), where VT (Baseline) and VT (Day 1) are the total distribution volumes obtained at Baseline and after TAK-935 administration, respectively and VND is the non-displaceable volume of distribution. The occupancy is determined as the slope of the linear regression of the plot, and the VND as the x-intercept. Data was reported only for TAK-935 600 mg because only first two participants were analyzed at 10 hour post-TAK-935 dose.|10 hours post-TAK-935 dose|PET target occupancy set where 10 hour post-TAK-935-dose assessment were available. PET target occupancy set included all participants who received study drug (TAK-935) and had a technically adequate Baseline PET scan and at least 1 technically adequate post-TAK-935 dose PET scan.||percentage of occupancy|||Number
637268|NCT02497235|Primary|CH24H Brain Enzyme Occupancy as a Function of TAK-935 Plasma Concentration at 2 Hours Post-TAK-935 Dose|CH24H brain enzyme occupancy was obtained by graphical analysis of global occupancy plot. Global occupancy plot was calculated as: VT (Baseline) - VT (Day 1) = Occupancy (Day 1) * (VT [Baseline] - VND), where VT (Baseline) and VT (Day 1) are the total distribution volumes obtained at Baseline and after TAK-935 administration, respectively and VND is the non-displaceable volume of distribution. The occupancy is determined as the slope of the linear regression of the plot, and the VND as the x-intercept.|2 hours post-TAK-935 dose|PET target occupancy set where 2 hour post-TAK-935-dose assessment were available. PET target occupancy set included all participants who received study drug (TAK-935) and had a technically adequate Baseline PET scan and at least 1 technically adequate post-TAK-935 dose PET scan.||percentage of occupancy|||Number
637269|NCT02497235|Primary|Cholesterol 24S-Hydroxylase (CH24H) Brain Enzyme Occupancy as a Function of TAK-935 Plasma Concentration at 45 Minutes Post-TAK-935 Dose|CH24H brain enzyme occupancy was obtained by graphical analysis of global occupancy plot. Global occupancy plot was calculated as: total volume of distribution [VT] (Baseline) - VT (Day 1) = Occupancy (Day 1) * (VT [Baseline] - non-displaceable volume of distribution [VND]), where VT (Baseline) and VT (Day 1) are the total distribution volumes obtained at Baseline and after TAK-935 administration, respectively and VND is the non-displaceable volume of distribution. The occupancy is determined as the slope of the linear regression of the plot, and the VND as the x-intercept. Data was reported only for TAK-935 600 mg because only first two participants were analyzed at 45 minutes post-TAK-935 dose.|45 minutes post-TAK-935 dose|PET target occupancy set where 45 minutes post-TAK-935-dose assessment were available. PET target occupancy set included all participants who received study drug (TAK-935) and had a technically adequate Baseline PET scan and at least 1 technically adequate post-TAK-935 dose PET scan.||percentage of occupancy|||Number
637270|NCT02496533|Secondary|Change in Pulse Rate|A trained clinician will measure and record the subject's radial pulse rate using standard practices.|Baseline and After Imaging|All patients completing the study per protocol were included in the analysis.||beats per minute||Standard Deviation|Mean
637271|NCT02496533|Secondary|Change in Respiration Rate in Breaths Per Minute|A trained clinician will measure and record the subject's respiration rate using standard practices.|Baseline and After Imaging|All patients completing the study per protocol were included in the analysis.||breaths per minute||Standard Deviation|Mean
637272|NCT02496533|Secondary|Change in Blood Pressure in mmHg|A trained clinician will measure and record the subject's blood pressure using standard practices.|Baseline and After Imaging|All patients completing the study per protocol were included in the analysis.||mmHg||Standard Deviation|Mean
637273|NCT02496533|Primary|Change in Anxiety as Measured by Visual Analog Scale|Subjects self-reported their perceived anxiety by marking a visual analog scale (VAS). The VAS covers the range 0 to 10. Higher values indicate greater anxiety (worse outcome). Analysis based on difference reported anxiety score between Baseline and after imaging.|Baseline and After Imaging|All patients completing the study per protocol were included in the analysis.||units on a scale||Standard Deviation|Mean
637274|NCT02496221|Secondary|Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick|Urine dipstick test was carried out on Day -1 and at Follow-up. Urinalysis parameters assessed were glucose, ketones, nitrite and protein. Dipstick results were categorized as Normal (glucose), Negative or Trace (ketones), and Negative (nitrite and protein). Only participants available at the indicated time points (as represented by n=X, X, X in the category titles) were analyzed. The resultant fields with no available data have been represented by 'NA'.|Day -1 and Follow-up (assessed up to a total of approximately 12 weeks)|All Subjects||Participants|||Number
637275|NCT02496221|Secondary|Part A: Number of Participants With at Least One Non-serious Adverse Event (AE), Serious Adverse Event (SAE), or Drug-related Adverse Event|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, associated with liver injury and impaired liver function defined as alanine aminotransferase >=3 x upper limit of normal (ULN), and total bilirubin >=2 x ULN or international normalised ratio >1.5. AEs were classified as potentially drug-related, based on the investigator's judgement. Refer to the general AE/SAE module for a list of AEs and SAEs.|From Day -1 in treatment period 1 and up to Follow-up Visit (a total of approximately 12 weeks)|All Subjects||Participants|||Number
645347|NCT02181127|Secondary|Mean CGMG During Exercise||2 weeks||||||
637276|NCT02496221|Secondary|Change From Baseline in Electrocardiogram (ECG) Parameters|Single 12-lead ECG was obtained in a semi-supine position after 5 minutes of rest at each indicated time point using an ECG machine that automatically calculated the heart rate and measured the PR, QRS, QT, and QT corrected by Fridericia's formula (QTcF) intervals. Change from Baseline was calculated as value at indicated time point minus Baseline value.|Baseline (Day -1) and Day 4 in each treatment period, and at Follow-up (at approximately Week 12)|All Subjects||Milliseconds (msec)||Standard Deviation|Mean
637277|NCT02496221|Secondary|Number of Participants With Clinical Chemistry and Hematology Abnormalities of Potential Clinical Importance|The following parameters were measured through blood sampling. Hematology: Hematocrit, Hemoglobin, Lymphocytes, Neutrophil Count, Platelet Count, While Blood Cell Count (WBC); Clinical Chemistry: Albumin, Calcium, Creatinine, Glucose, Magnesium, Phosphorus, Potassium, Sodium, Total carbon dioxide; Liver Function Tests: Alanine transaminase (ALT), Aspartate transaminase, Alkaline Phosphatase, Total Bilirubin, Total Bilirubin + ALT. Values were considered to be of potential clinical importance if they had a 'low' or 'high' flag with respect to a pre-defined clinical concern range. Only participants starting each period (represented by n=X) with a particular treatment were analyzed. The follow-up time point is not restricted to a treatment or treatment period.|Day -1 in each treatment period and Follow-up (at approximately Week 12)|All Subjects||Participants|||Number
637278|NCT02496221|Secondary|Change From Baseline in Heart Rate|Baseline is defined as Day 1 (pre-dose) visit. Heart rate was measured in a semi-supine position after 5 minutes of rest, at each indicated time point. Assessments were performed on Day -1, Day 2, Day 3 and 15 minutes (-15 min) prior to dosing and 80 min post dosing on Day 4. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants available at the indicated time points (represented by n=X,X in the category titles) were analyzed.|Day -1, Baseline Day 1(Pre-dose), Day 2, Day 3, and 15 minutes (-15 min) prior to dosing and 80 min post dosing on Day 4 in each treatment period and Follow-up (a total of approximately 12 weeks)|All Subjects||Beats per minute (bpm)||Standard Deviation|Mean
637279|NCT02496221|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Baseline is defined as Day 1 (pre-dose) visit. SBP and DBP were measured in a semi-supine position after 5 minutes of rest, at each indicated time point. Assessments were performed on Day -1, Day 1 (pre-dose), Day 2, Day 3 and 15 minutes (-15 min) prior to dosing and 80 min post dosing on Day 4. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants available at the indicated time points (represented by n=X,X in the category titles) were analyzed.|Day -1, Baseline Day 1(Pre-dose), Day 2, Day 3, and 15 minutes (-15 min) prior to dosing and 80 min post dosing on Day 4 in each treatment period and Follow-up (assessed up to a total of approximately 12 weeks)|All Subjects||Millimeters of mercury (mmHg)||Standard Deviation|Mean
637280|NCT02496221|Primary|Maximum Change From Baseline in Common Bile Duct Diameter During CCK Infusion|Common bile duct ultrasonography was done at Day 1 (-15, -10, and -5 minutes [min] relative to start of albiglutide/placebo injection) and Day 4 ([prior to CCK infusion] -15, -10, -5 min, followed by [during CCK infusion] every 5 min between 0 and 50 min, then [after CCK infusion] at 60, 70, and 80 min, relative to the start of CCK infusion). Baseline is the average of the three diameter assessments at -15, -10, and -5 minutes relative to start of CCK infusion on Day 4. Change from Baseline was calculated as the value at the indicated time point minus the Baseline value. Adjusted mean and its standard error have been presented.|Day 4 in each treatment period|Evaluable for Bile: Participants with Baseline and post-Baseline common bile duct diameter values for both periods||Centimetre (cm)||Standard Error|Mean
637281|NCT02496221|Primary|Maximum Change From Baseline in Main Pancreatic Duct Diameter During CCK Infusion|Pancreatic duct ultrasonography was done at Day 1 (-15, -10, and -5 minutes [min] relative to start of albiglutide/placebo injection) and Day 4 ([prior to CCK infusion] -15, -10, -5 min, followed by [during CCK infusion] every 5 min between 0 and 50 min, then [after CCK infusion] at 60, 70, and 80 min, relative to the start of CCK infusion). Baseline is the average of the three diameter assessments at -15, -10, and -5 minutes relative to start of CCK infusion on Day 4. Change from Baseline was calculated as the value at the indicated time point minus the Baseline value. Adjusted mean and its standard error are presented. Baseline was calculated as the value at the indicated time point minus the Baseline value. Only those participants available at the indicated time points were analyzed.|Day 4 in each treatment period|Evaluable for Pancreatic: Participants with Baseline and post-Baseline pancreatic duct diameter values for both periods||Centimetre (CM)||Standard Error|Mean
637282|NCT02496221|Primary|Time at Which the Maximum Effect (Emax VL) Occurred (TEmax VL) During the CCK Infusion|Gallbladder ultrasonography was done at Day 1 (-15, -10, and -5 minutes [min] relative to start of albiglutide/placebo injection) and Day 4 ([prior to CCK infusion] -15, -10, -5 min, followed by [during CCK infusion] every 5 min between 0 and 50 min, then [after CCK infusion] at 60, 70, and 80 min, relative to the start of CCK infusion).|Day 4 in each treatment period|Evaluable Subjects||Minutes||Standard Deviation|Mean
637283|NCT02496221|Primary|Maximum Absolute Change From Baseline in Value of Gallbladder Volume (Emax VL) During CCK Infusion, as a Measure of Maximum Effect|Gallbladder ultrasonography was done at Day 1 (-15, -10, and -5 minutes [min] relative to start of albiglutide/placebo injection) and Day 4 ([prior to CCK infusion] -15, -10, -5 min, followed by [during CCK infusion] every 5 min between 0 and 50 min, then [after CCK infusion] at 60, 70, and 80 min, relative to the start of CCK infusion). Baseline gallbladder volume is the average of the 3 gallbladder volume measurements prior to CCK infusion on Day 4, for each treatment period. Adjusted mean and its standard error are presented.|Day 4 in each treatment period|Evaluable Subjects||Millilitre (mL)||Standard Error|Mean
637284|NCT02496221|Primary|Area Under the Effect Curve for Gallbladder Volume (AUEC VL)|Gallbladder ultrasonography was done at Day 1 (-15, -10, and -5 minutes [min] relative to start of albiglutide/placebo injection) and Day 4 ([prior to CCK infusion] -15, -10, -5 min, followed by [during CCK infusion] every 5 min between 0 and 50 min, then [after CCK infusion] at 60, 70, and 80 min, relative to the start of CCK infusion). Adjusted mean and its standard error is presented.|Day 4 in each treatment period|Evaluable Subjects||mL*min||Standard Error|Mean
637285|NCT02496221|Primary|Maximum Gallbladder Ejection Fraction Value During CCK Infusion|Gallbladder ultrasonography was done at Day 1 (-15, -10, and -5 minutes [min] relative to start of albiglutide/placebo injection) and Day 4 ([prior to CCK infusion] -15, -10, -5 min, followed by [during CCK infusion] every 5 min between 0 and 50 min, then [after CCK infusion] at 60, 70, and 80 min, relative to the start of CCK infusion).|Day 1 and Day 4 in each treatment period|Evaluable Subjects||Percentage||Standard Error|Mean
637286|NCT02496221|Primary|Time at Which the Maximum Effect (Emax GEF) Occurred (TEMAXEF) During the CCK Infusion|Gallbladder ultrasonography was done at Day 1 (-15, -10, and -5 minutes [min] relative to start of albiglutide/placebo injection) and Day 4 ([prior to CCK infusion] -15, -10, -5 min, followed by [during CCK infusion] every 5 min between 0 and 50 min, then [after CCK infusion] at 60, 70, and 80 min, relative to the start of CCK infusion).|Day 4 in each treatment period|Evaluable Subjects||Minutes||Standard Deviation|Mean
637287|NCT02496221|Primary|Area Under the Effect Curve for Gallbladder Ejection Fraction (AUEC GEF)|Gallbladder ultrasonography was done at Day 1 (-15, -10, and -5 minutes [min] relative to start of albiglutide/placebo injection) and Day 4 ([prior to CCK infusion] -15, -10, -5 min, followed by [during CCK infusion] every 5 min between 0 and 50 min, then [after CCK infusion] at 60, 70, and 80 min, relative to the start of CCK infusion). Adjusted mean and its standard error have been presented.|Day 4 in each treatment period|Evaluable Subjects||%*min||Standard Error|Mean
637288|NCT02496221|Primary|Maximum Absolute Value of Gallbladder Ejection Fraction (Emax GEF) During Cholecystokinin (CCK) Infusion, as a Measure of Maximum Effect|Gallbladder ejection fraction (EF) is defined as the reduction in gallbladder volume at any time point from Baseline divided by baseline gallbladder volume and multiplied by 100. Baseline gallbladder volume is the average of the 3 gallbladder volume measurements prior to CCK infusion on Day 4, for each treatment period. Gallbladder ultrasonography was done at Day 1 (-15, -10, and -5 minutes [min] relative to start of albiglutide/placebo injection) and Day 4 ([prior to CCK infusion] -15, -10, -5 min, followed by [during CCK infusion] every 5 min between 0 and 50 min, then [after CCK infusion] at 60, 70, and 80 min, relative to the start of CCK infusion). Adjusted mean and its standard error have been presented.|Day 4 in each treatment period|Evaluable Subjects: Participants in the ‘All Subjects’ population who had gallbladder ultrasonography assessment pre-treatment and post-Baseline (during CCK infusion) for both periods. 'All Subjects' population comprised participants who received at least one dose of Investigational product.||Percent of gallbladder EF||Standard Error|Least Squares Mean
637289|NCT02496039|Primary|Scores on the Impact of PBA on Informant Scale|The study was terminated prematurely because of difficulty with recruiting. Analysis for this outcome measure was not performed because data were not collected prior to termination.|180 days||||||
637290|NCT02496039|Primary|Number of Participants Using Concomitant Psychotropic Medication|The study was terminated prematurely because of difficulty with recruiting. Analysis for this outcome measure was not performed because data were not collected prior to termination.|180 days||||||
637291|NCT02496039|Primary|Scores on the Minimum Data Set (MDS) Sections of Presumed Relevance to PBA, Including Sections on Speech, Cognition, Mood, Behavior, Health Condition, and Medication|The study was terminated prematurely because of difficulty with recruiting. Analysis for this outcome measure was not performed because data were not collected prior to termination.|180 days||||||
637292|NCT02496039|Primary|Scores on the Impact of Pseudobulbar Affect (PBA) on Participant Scale|The study was terminated prematurely because of difficulty with recruiting. Analysis for this outcome measure was not performed because data were not collected prior to termination.|180 days||||||
637293|NCT02496039|Primary|Number of Participants With the Indicated Responses to the Neuropsychiatric Inventory-Nursing Home (NPI-NH) Questionnaire|The study was terminated prematurely because of difficulty with recruiting. Analysis for this outcome measure was not performed because data were not collected prior to termination.|180 days||||||
637294|NCT02496039|Primary|Scores on the Patient Global Impression of Change (PGIC) Scale|The study was terminated prematurely because of difficulty with recruiting. Analysis for this outcome measure was not performed because data were not collected prior to termination.|180 days||||||
637295|NCT02496039|Primary|Scores on the Clinical Global Impression of Change (CGIC) Scale|The study was terminated prematurely because of difficulty with recruiting. Analysis for this outcome measure was not performed because data were not collected prior to termination.|180 days||||||
637296|NCT02496039|Primary|Scores on the Clinical Global Impression of Severity of Illness (CGIS) Scale|The study was terminated prematurely because of difficulty with recruiting. Analysis for this outcome measure was not performed because data were not collected prior to termination.|180 days||||||
637297|NCT02496039|Primary|Scores on the Center for Neurologic Study-Lability Scale (CNS-LS)|The study was terminated prematurely because of difficulty with recruiting. Analysis for this outcome measure was not performed because data were not collected prior to termination.|180 days||||||
637298|NCT02496000|Secondary|The Effect of ORMD-0801 on Changes in HbA1c|The effect of ORMD-0801 (Dose 1 and Dose 2 pooled and individually) on percent changes from baseline to Wk 4 in HbA1c|Study day 1 (± 1 day) through Study day 29 (± 1 day)||09/2017||||
637299|NCT02496000|Secondary|Effect of ORMD-0801 on Mean Daytime Glucose|The effect of ORMD-0801 (Dose 1 and Dose 2 pooled and individually) on changes from baseline to Wk 4 of Continuous Glucose Monitoring (CGM) of mean daytime glucose, measured in mg/dL|Study day 1 (±1 day) through Study day 29 (± 1 day)||09/2017||||
637300|NCT02496000|Secondary|The Difference of Mean (mg/dL) Fasting Glucose From Baseline to Week 4|The effect of ORMD-0801 (Dose 1 and Dose 2 pooled and individually) on absolute changes from baseline to Wk 4 in fasting morning blood glucose.|Study day 1 (± 1 day) through Study day 29 (± 1 day)||09/2017||||
637301|NCT02496000|Secondary|The Effect of ORMD-0801 on Mean 24-hour Glucose|The effect of ORMD-0801 (Dose 1 and Dose 2 individually and pooled) on mean 24-hour glucose based on 2 nights of CGM data by comparison of the mean change between baseline and Wk 4 of ORMD-0801 treatment and the placebo groups measured in mg/dL|Study day -7 (± 1 day) through Study day 1 (± 1 day), and Study day 22 (±1 day) - Study day 29 (± 1 day)||09/2017||||
637314|NCT02494596|Secondary|Apparent Volume of Distribution of Pertuzumab|The volume of distribution at steady state (Vss), also known as apparent volume of distribution, is a pharmacological, theoretical volume that the total amount of administered drug would have to occupy (if it were uniformly distributed), to provide the same concentration as it currently is in blood plasma. Vss was measured in mL|Cycle 1: Days 2, 5, 8 and 15 Postdose; Cycle 2: Day 1 at drug administration, predose and 15 minutes postdose, and predose on Days 8, 15 and 22|ITT population||mL||Standard Deviation|Mean
637508|NCT02484729|Primary|Safety and Tolerability of AZD9977 by Assessing Number of Participants With Clinically Significant Trends in 12-lead Electrocardiograms|To assess the safety and tolerability of single ascending doses of AZD9977|For up to 45 days, i.e. from Screening to Follow-up|All subjects who received at least one dose of IMP and for whom any safety post-dose data were available were included in the safety analysis for the study.||Number of participants|||Number
637302|NCT02496000|Primary|Measure of the Mean Night Time Glucose Levels Based on Two Nights of Glucose Measurements.|The Effect of ORMD-0801 (Doses 1 & 2, Pooled) on Mean Night Time Glucose Levels (measured in mg/dL) Based on 2 Nights of Continuous Glucose Monitor (CGM) Data by Comparison of the Mean Change Between Baseline and Wk 4 of ORMD-0801 Treatment and Placebo Groups. The primary analysis will be based on the results from the two last days, unless technical difficulties preclude calculation of the weighted mean glucose levels. In this case, the last two days (selected between days 5, 6, and 7) with at least 80% of the expected number of measurements will be used. If days 5, 6 and 7 do not have 2 days with at least 80% of the expected number of measurements for a specific subject, then the value will be missing for that subject.|Baseline-Study day -7 (± 1 day) through Study day 1 (± 1 day), and Week 4 -Study day 22 (± 1 day) through Study day 29 (± 1 day)|Intend-to-Treat Population, 80% trimming. The mean values will be analyzed using a one-way analysis of variance (ANOVA) model. The residuals from the ANOVA will be analyzed to verify that they are normally distributed. If not normally distributed, then a Kruskal-Wallis test (one-way analysis of variance on the ranks) will be performed.||mg/dL||Standard Deviation|Mean
637303|NCT02495948|Primary|Mean Ex-vivo Cholesterol Deposits After 30 Days of Wear|The contact lens (right eye) was removed and stored dry and frozen until analysis. Total cholesterol deposits (cholesterol and cholesterol esters) were extracted from the lens and measured in micrograms. Lower deposits indicate increased lens performance. Study originally intended to analyze 36 lenses per arm, but actual number of lenses analyzed was less due to measurement error.|Day 30, each product|Intent-to-Treat analysis set||micrograms|Lenses|Standard Deviation|Mean
637304|NCT02495831|Secondary|Relative Bioavailability (Frel)|calculated as ratio between AUC0-t (test) / AUC0-t (reference)|24 hours|||ratio||Standard Deviation|Mean
637305|NCT02495831|Secondary|Lamda z||24 hours|||1/hours||Standard Deviation|Mean
637306|NCT02495831|Secondary|Tmax and T1/2||24 hours|||hours||Standard Deviation|Least Squares Mean
637307|NCT02495831|Secondary|Evaluate Diclofenac Rate of Absorption Reported as Plasma Cmax After Single Administration of 50 mg Diclofenac With and Without 200 mg of Safinamide.|Cmax, of plasma diclofenamic acid after T2 single dose, with and without T1 co-administration. The parametric point estimators (PE) for the ratios of T2 treatment with T1 co-administration / T2 treatment without T1 co-administration for the PK parameters under consideration, and the two-sided 90% confidence interval (CI), were calculated using the adjusted least squares means (LSMEANS) from the ANOVA. LSmeans differences obtained in the log scale for Cmax were back-transformed to obtain the PE (i.e. geometric mean ratio) and the two-sided 90% CI as percentages.|24 hours|||ng/mL||Standard Deviation|Least Squares Mean
637308|NCT02495831|Primary|To Evaluate Plasma Diclofenamic Acid Extent of Exposure Reported as Plasma AUC After Single Administration of 50 mg Diclofenac Sodium, With and Without Co-administration of a Single 200 mg Dose of Safinamide.|Plasma diclofenamic acid AUC0-t after T2 single dose, with and without T1 co-administration. To measure AUC plasma samples were taken by the participants at different time points, and the concentrations of diclofenac and safinamide were measured. AUC0-t is the area under the concentration-time curve from administration to the last observed concentration time t; PK parameters AUC0-t were analysed using analysis of variance (ANOVA). Before analysis, the data were transformed using a neperian logarithmic transformation. ANOVA was performed taking into account treatment, period, sequence and subject (sequence) as fixed effects with a variance components structure of the covariance matrix.|24 hours|healthy volunteers||h X ng per mL||Standard Deviation|Mean
637309|NCT02495623|Primary|Change From Baseline in the Area Under the Curve (AUC) of Breath CH4 Production at Day 7||7 days|79 subjects consented/randomized to treatment. 63 dosed subjects. 59 subjects (21, 20 & 18 for the placebo, 21mg and 42mg, respectively) were included for the analysis of AUC on Day 7, and the subjects with missing CH4 values at either baseline or Day 7 were excluded from the analysis since the area under the curve could not be calculated.||hours*ppm||Standard Deviation|Mean
637310|NCT02494596|Secondary|Time to Maximum Plasma Concentration of Capecitabine and it's Metabolites When Given Alone and in Combination With Pertuzumab|Capecitabine is a novel oral fluoropyrimidine carbamate that is preferentially converted to the cytotoxic moiety fluorouracil (5-fluorouracil; 5-FU) in target tumour tissue through a series of 3 metabolic steps through the intermediate metabolites 5’-deoxy-5-fluorocytidine (5'-DFCR), 5’-deoxy-5-fluorouridine (5'-DFUR), and α-fluoro-β-alanine (FBAL). Tmax is defined as the time after administration of a drug when the maximum plasma concentration is reached; when the rate of absorption equals the rate of elimination.|Day -7: Predose, 30 minutes, 1, 2, 3, 4, 5, 6 and 10 hours postdose; Cycle 1 Day 1: Predose, 0 and 30 minutes, 1, 2, 3, 4, 5, 6 and 10 hours Postdose|ITT population||hours||Standard Deviation|Mean
637311|NCT02494596|Secondary|Maximum Plasma Concentration of Capecitabine and it's Metabolites When Given Alone and in Combination With Pertuzumab|Capecitabine is an oral fluoropyrimidine carbamate that is preferentially converted to the cytotoxic moiety 5-FU in target tumour tissue through a series of 3 metabolic steps through the intermediate metabolites 5'-DFCR, 5'-DFUR, and FBAL. Cmax refers to the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administrated and prior to the administration of a second dose and is measures as nanograms per milliliter (ng/mL).|Day -7: Predose, 30 minutes, 1, 2, 3, 4, 5, 6 and 10 hours postdose; Cycle 1 Day 1: Predose, 0 and 30 minutes, 1, 2, 3, 4, 5, 6 and 10 hours Postdose|ITT population||ng/mL||Standard Deviation|Mean
637312|NCT02494596|Secondary|Plasma Half-Life of Capecitabine and it's Metabolites When Given Alone and in Combination With Pertuzumab|Capecitabine is a novel oral fluoropyrimidine carbamate that is preferentially converted to the cytotoxic moiety fluorouracil (5-fluorouracil; 5-FU) in target tumour tissue through a series of 3 metabolic steps through the intermediate metabolites 5’-deoxy-5-fluorocytidine (5'-DFCR), 5’-deoxy-5-fluorouridine (5'-DFUR), and α-fluoro-β-alanine (FBAL). The biological half-life or terminal half-life is the time in days it takes for it to lose half of its pharmacologic activity.|Day -7: Predose, 30 minutes, 1, 2, 3, 4, 5, 6 and 10 hours postdose; Cycle 1 Day 1: Predose, 0 and 30 minutes, 1, 2, 3, 4, 5, 6 and 10 hours Postdose|ITT population||hours||Standard Deviation|Mean
637313|NCT02494596|Secondary|Apparent Total Clearance of Pertuzumab|Clearance (expressed as volume/time) describes the removal of drug from a volume of plasma in a given unit of time (drug loss from the body). It is measured as milliliters per day (mL/day).|Cycle 1: Days 2, 5, 8 and 15 Postdose; Cycle 2: Day 1 at drug administration, predose and 15 minutes postdose, and predose on Days 8, 15 and 22|ITT population||mL/day||Standard Deviation|Mean
645348|NCT02181127|Secondary|Percentage of Subjects With Mean CGMG < 154mg/dl||2 weeks||||||
637315|NCT02494596|Secondary|AUC From Time Zero to Infinity (AUC 0-infinity) of Pertuzumab|The AUC0-infinity is calculated from time 0 (prior to administration of medication) to infinity (the time of complete elimination of the drug). The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. AUC is measured as nanograms times days per milliliter (ng*day/mL).|Cycle 1: Days 2, 5, 8 and 15 Postdose; Cycle 2: Day 1 at drug administration, predose and 15 minutes postdose, and predose on Days 8, 15 and 22|ITT population||ng*day/mL||Standard Deviation|Mean
637316|NCT02494596|Secondary|Area Under the Concentration Curve From Time Zero to Last Measurement (AUC 0-last) of Pertuzumab|The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC0-last is calculated from time 0 (prior to administration of medication) to last measured data point. The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. AUC was measured as ng*day/mL.|Cycle 1: Days 2, 5, 8 and 15 Postdose; Cycle 2: Day 1 at drug administration, predose and 15 minutes postdose, and predose on Days 8, 15 and 22|ITT population||ng*day/mL||Standard Deviation|Mean
637317|NCT02494596|Secondary|Time to Maximum Plasma Concentration (Tmax) of Pertuzumab|Tmax is defined as the time after administration of a drug when the maximum plasma concentration is reached; when the rate of absorption equals the rate of elimination. Tmax was measured in days.|Cycle 1: Days 2, 5, 8 and 15 Postdose; Cycle 2: Day 1 at drug administration, predose and 15 minutes postdose, and predose on Days 8, 15 and 22|ITT population||days||Standard Deviation|Mean
637318|NCT02494596|Secondary|Maximum Plasma Concentration (Cmax) of Pertuzumab|Cmax refers to the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administrated and prior to the administration of a second dose and was measured as nanograms per milliliter (ng/mL).|Cycle 1: Days 2, 5, 8 and 15 Postdose; Cycle 2: Day 1 at drug administration, predose and 15 minutes postdose, and predose on Days 8, 15 and 22|ITT population||ng/mL||Standard Deviation|Mean
637319|NCT02494596|Secondary|Plasma Half-Life (t1/2) of Pertuzumab|The biological half-life or terminal half-life of pertuzumab is the time in days it takes for it to lose half of its pharmacologic activity. t1/2 was measured in days.|Cycle 1: Days 2, 5, 8 and 15 Postdose; Cycle 2: Day 1 at drug administration, predose and 15 minutes postdose, and Predose on Days 8, 15 and 22|ITT population||days||Standard Deviation|Mean
637320|NCT02494596|Secondary|Percentage of Participants With DLTs|DLTs were defined as follows: 1)Any non-hematological toxicity greater than or equal to (≥) Grade 3 according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 except for fever, chills and flu-like symptoms, in spite of adequate toxicity management; 2) Grade 4 neutropenia lasting > 7 days; 3) Febrile neutropenia; 4) Thrombocytopenia Grade 4 or any thrombocytopenia requiring platelet transfusion; 5) Any subjectively intolerable toxicity felt by the investigator to be related to either one of the compounds. Participants who withdrew from the study without completing the first treatment cycle for reasons other than DLT were not considered evaluable for DLT.|Cycle 1 (3 Weeks)|Safety population||percentage of participants|||Number
637321|NCT02494596|Primary|Maximum Tolerated Dose (MTD) of the Combination of Pertuzumab and Capecitabine|MTD was defined as the highest tolerated dose combination of capecitabine (825 mg, 1000 mg or 1250 mg) and pertuzumab, without causing Dose Limiting Toxicities (DLTs). DLTs were defined as follows: 1) Any non-hematological toxicity greater than or equal to (≥) Grade 3 according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 except for fever, chills and flu-like symptoms, in spite of adequate toxicity management; 2) Grade 4 neutropenia lasting > 7 days; 3) Febrile neutropenia; 4) Thrombocytopenia Grade 4 or any thrombocytopenia requiring platelet transfusion; 5) Any subjectively intolerable toxicity felt by the investigator to be related to either one of the compounds. Participants who withdrew from the study without completing the first treatment cycle for reasons other than DLT were not considered evaluable for DLT. MTD was measured in mg/m^2.|Cycle 1 (3 Weeks)|The Safety Population included all participants who received any amount of study medication and who had at least one post-baseline safety follow-up.||mg/m^2|||Number
637322|NCT02494440|Secondary|Gestational Age Calculated by Femur Length Measurement by Five-Dimensional Ultrasound|"The femur length at Five-Dimensional Ultrasound: To obtain 3D volume data, the entire bone length of the femur was identified on the screen, as in the 2D-ultrasound measurement, and the long axis of the femur was placed in the direction of the x axis in the image in which the ultrasound beam was perpendicular to the bone. The 5D LB set key was pressed on the system, wherein the system automatically analyzed the 3D volume data, reconstructed the 3D image of the long bones, and displayed the measured length of the femur length on the screen was measured by pressing 5D LB Button to extract Fetal Long Bones automatically.
then, gestational Age Calculated by femur length measurement"|26 - 40 weeks of gestation|Ninety pregnant women were recruited from the the Fetal Care Unit who fulfilled the inclusion criteria||weeks||Standard Deviation|Mean
637323|NCT02494440|Secondary|Gestational Age Calculated by Femur Length Measurement by Two-Dimensional Ultrasound|"The femur length at Two-Dimensional Ultrasound (Gold standard) was made from the center of the 'U' shape at each end of the bone. After the long axis of the fetus was identified, the transducer was turned 90 degrees to produce a cross sectional image of fetal trunk, maintaining the 90 degrees angle until the lower spine and iliac crest were identified, then the transducer was rotated until a full femur was imaged. The femur length was measured from the center of the U shape at each end of the bone; this represented the length of the metaphysis).
then , Gestational Age Calculated by femur length measurement"|26 - 40 weeks of gestation|90 pregnant women were recruited from the the Fetal Care Unit who fulfilled the inclusion criteria||weeks||Standard Deviation|Mean
637324|NCT02494440|Primary|Gestational Age Calculated by Accurate Dates of the Last Menstrual Period|"The patient must be sure of her last normal menstrual period, last three regular cycles and no hormonal contraception before pregnancy.
Gestational age calculated by the last menstrual period"|26 - 40 weeks of gestation|90 pregnant women were recruited from the the Fetal Care Unit who fulfilled the inclusion criteria||weeks||Standard Deviation|Mean
637325|NCT02494323|Secondary|Benefit Satisfaction Willingness to Continue (BSW) Questionnaire|Number of subjects who benefited or not benefited from the dual channel electrode was counted, number of patients who were satisfied or not satisfied with the dual channel electrode was counted, number of subjects who were willing to continue or who were unwilling to continue with the dual channel electrode was counted|7 months|Five subjects were excluded from filling up the BSW questionnaire, since the Segmented Electrode (SE) did not produce motor reaction in the ankle||participants|||Number
637326|NCT02494323|Primary|Ankle Movement as Good as or Better With the Segmented Electrode as With the QFE|Subjects were fitted with the L300 Cuff that houses the single channel QFE and then the modified cuff that houses the dual channel segmented electrode. Subjects were stimulated first sitting and then after optimal ankle elevation was achieved, they walked with the stimulation. The clinician documented ankle movement on a 5 point scale: 1-inverted dorsiflexion, 2-slightly inverted dorsiflexion, 3-neutral dorsiflexion,4- slightly everted dorsiflexion, 5- everted dorsiflexion. The clinician documented the number of subjects who achieved each movement with each electrode according to the 5 point scale.|7 months|All subjects suffer from foot drop due to upper motor neuron lesion||units on a scale||Standard Deviation|Mean
637328|NCT02493127|Primary|Difference in Grip Strength Measured With Dynamometer|Difference in Grip strength of both hands after completing intervention. Each participant completed the grip strength measurement 3 times with both hands at enrollment (day 1). The results reported represent an increase or decrease in mean grip strength and maximum grip strength after completing the intervention.|Day 1|||pounds||Standard Deviation|Mean
637329|NCT02493127|Primary|Difference in Grip Strength Measured With Dynamometer|Difference in Grip strength of the injured hand after completing intervention. Each participant completed the grip strength measurement 3 times on the injured hand at enrollment (day 1). The results reported represent an increase or decrease in mean grip strength and maximum grip strength after completing the intervention.|Day 1|||pounds||Standard Deviation|Mean
637330|NCT02493127|Primary|Difference in Grip Strength Measured With Dynamometer|Difference in Grip strength of the non-affected hand after completing intervention. Each participant completed the grip strength measurement 3 times on the non-affected hand at enrollment (day 1). The results reported represent an increase or decrease in mean grip strength and maximum grip strength after completing the intervention.|Day 1|||pounds||Standard Deviation|Mean
637331|NCT02493127|Primary|Positive Pain Catastrophizing Scale (PCS)|The positive pain catastrophizing scale (PCS) is a positively-phrased 13-item scale to measure catastrophic thinking. The scale is from 0-4 and scores range from 0-52, a higher score indicates less catastrophic thinking about pain.|enrollment|||units on a scale||Standard Deviation|Mean
637332|NCT02493127|Primary|Pain Catastrophizing Scale (PCS)|The pain catastrophizing scale is a 13-item scale to measure catastrophic thinking. The scale is from 0-4 and scores range from 0-52, a lower score indicates less catastrophic thinking about pain.|enrollment|||units on a scale||Standard Deviation|Mean
637333|NCT02493088|Secondary|Number of Observed Situations Per Type of Aberrant Driving Behavior (Auto-aggressive, Aggressive or Other Hetero Transgression)|"Auto-aggressive: attempted suicide, any gesture of mutilation (scarification, punching in a wall, etc.) Aggressive: rixes with fellow inmates or prison staff, attempted homicides, sexual assaults, etc.
Other hetero transgression: Failure to comply with the rules of the institution, illegal entry of illicit objects into the establishment, consumption of toxic materials, destruction of property, etc."|6 months|||number of observed situations|||Number
637334|NCT02493088|Secondary|Percentage of Aberrant Driving Behaviors With Contextual Element Observed Before Aberrant Driving Behaviors|"Collected contextual elements were :
Disorders in the institution (with a caregiver, frustration with the rules)
Difficulty / frustration with an inmate
Difficulty / frustration with the entourage
Consumption of alcohol or other toxic substances
Steps in the judicial process (refusal of parole, reduction of sentence ...)
Psychiatric symptoms: delirious, sleep disorders, nightmares The numerator for the percentage calculated is the number of aberrant driving behaviors with contextual element.
The denominator for the percentage calculated is the total number of aberrant driving behaviors (with and without contextual element)"|6 months|||percent of aberrant driving behaviors|Number of aberrant driving behaviors|95% Confidence Interval|Number
637335|NCT02493088|Primary|The Number of Individuals Diagnosed With Antisocial Personality Disorder in Rochefort Prison With Aberrant Driving Behaviors.||6 months|||participants|||Number
637336|NCT02493036|Primary|Change From Study 1 (NCT02495623) Baseline in the Area Under the Curve (AUC) of Breath CH4 Production, Based on a 180-minute Lactulose Breath Test (LBT) at Day 56 Post-dose.||56 days|In this table, there are 16, 18 and 14 subjects in the 42mg/42mg, 21mg/42mg and Placebo/42mg group, respectively. This is a change-from-baseline analysis, only subjects with no missing values AT BOTH baseline and Day 56 are included in the analysis, so the number of subjects in each group is less than the number of subjects that started the study.||ppm*hr||Standard Deviation|Mean
637337|NCT02492984|Secondary|Number of Confirmed LETE in the Low Recovery Setting|LETE could also be lower than expected recovery of FVIII in the opinion of the investigator following infusion of Xyntha in the absence of confounding factors. The only confounding factors for low recovery were: known presence or subsequent identification of a FVIII inhibitor; known compromised Xyntha; faulty administration of Xyntha, including inadequate dosing.|From Day 1 up to participants had received treatment for 6 months or when participants had achieved 50 EDs whichever occurred first.|The safety analysis set was defined as all participants who received at least one dose of Xyntha during the study.||LETE bleeds|||Number
637338|NCT02492984|Secondary|Percentage of Less Than Expected Therapeutic Effect (LETE) in the On-Demand Setting|LETE occurred in the on-demand setting if 2 successive “No Response” ratings were recorded after 2 successive Xyntha drug infusions, respectively.The infusions must have been administered within 24 hours (less than or equal to 24 hours) of each other for treatment of the same bleeding event in the absence of confounding factors (prespecified). Therefore, LETE in the on-demand setting was based on the response to treatment of a bleeding episode (including those occurring during the surgical prophylaxis period). Note that on-demand treatments administered during the surgical prophylaxis period were also to be included.|From Day 1 up to participants had received treatment for 6 months or participants had achieved 50 EDs whichever occurred first.|The safety analysis set was defined as all participants who received at least one dose of Xyntha during the study.||percentage of bleeding episodes|bleeding episodes|95% Confidence Interval|Number
640703|NCT02336763|Primary|Reduction in Liver Metastasis||Up to 5 years|study terminated early no analysis conducted. Data was not collected from any subject for this Outcome Measure.|||||
637339|NCT02492984|Secondary|Average Infusion Dose and Total Factor VIII Consumption for On-Demand Treatment and Surgical Prophylaxis Treatment|The total amount (IU) infused for each Xyntha infusion recorded in the study drug infusion log case report form (CRF) was summed to calculate the total factor VIII consumption for each participant. The average infusion dose for each participant was calculated as his total factor VIII consumption (in IU) divided by the number of infusions administered. The total factor VIII consumption, divided by number of infusions, was summarized similarly to average infusion dose (IU).|On-Demand Group: Day 1 up to 6 months or 50 EDs whichever occurred first. Surgical Prophylaxis Group: Day of surgery to postoperative period. The duration of postoperative period is specified in previous endpoints.|All participants who received at least one dose of Xyntha during the study||International Unit (IU)||Standard Deviation|Mean
637340|NCT02492984|Secondary|Number of Participants With Transfusion Requirement for Surgical Prophylaxis Treatment|Number of participants with transfusion requirement for surgical prophylaxis treatment. Transfusion requirements during the intraoperative and the postoperative period were assessed by investigator or surgeon. The number of units and types of blood products transfused were recorded if applicable.|From day of surgery to postoperative period (at least 1-3 days post operation or until adequate wound healing for minor surgery or 4-6 days post operation or until threat resolved or adequate wound healing for major surgery)|"Surgical prophylaxis participants during their surgical prophylaxis period. The data for this outcome was not planned to be analyzed for the on-demand group."||participants|||Number
637341|NCT02492984|Secondary|Actual Estimated Blood Loss for Surgical Prophylaxis Treatment|Number of participants with blood loss in each category (Abnormal, Normal, and Absence). Blood loss during the intraoperative and the postoperative period were assessed by investigator or surgeon, which were rated as Abnormal, Normal, and Absence. Abnormal blood loss meant the blood loss was higher over the expectation for the non hemophilic participant.|From day of surgery to postoperative period (at least 1-3 days post operation or until adequate wound healing for minor surgery or 4-6 days post operation or until threat resolved or adequate wound healing for major surgery)|"Surgical prophylaxis participants during their surgical prophylaxis period. The data for this outcome was not planned to be analyzed for the on-demand group. Number of participants analyzed signifies participants evaluable for this outcome measure."||partcipants|||Number
637342|NCT02492984|Secondary|Hemostatic Efficacy for Surgical Prophylaxis Treatment|Assessment of hemostatic efficacy was determined by the investigator and/or surgeon using the 4 point Surgical Hemostasis Efficacy Rating Scale. Excellent: Achieved hemostasis comparable to that expected after similar surgery in a non hemophilic participant. Good: Prolonged time to hemostasis, with somewhat increased bleeding compared to that expected after similar surgery in a non hemophilic participant. Moderate: Obviously delayed hemostasis, but manageable with additional infusions. No Response: No hemostatic response. The percentage of observations in each hemostatic efficacy response category (excellent, good, moderate, none) was reported.|From day of surgery to postoperative period (at least 1-3 days post operation or until adequate wound healing for minor surgery or 4-6 days post operation or until threat resolved or adequate wound healing for major surgery)|"Surgical prophylaxis participants during their surgical prophylaxis period. The data for this outcome was not planned to be analyzed for the on-demand group."||percentage of observations|||Number
637343|NCT02492984|Secondary|Frequency of Xyntha Infusions to Treat Each New Bleed for On-Demand Group|The number of bleeds resolved with 1, 2, 3, 4, or >4 infusions was reported for each of the categories (1, 2, 3, 4, or >4 infusions needed to treat the bleed), in which the numerator was the number of bleeds falling into each category, and the denominator was the total number of new bleeds across all participants.|From Day 1 up to participants had received treatment for 6 months or when participants had achieved 50 EDs whichever occurred first.|"Participants with a bleed during the study for which on-demand treatment with Xyntha was administered. The data for this outcome was not planned to be analyzed for the surgical prophylaxis group."||percentage of bleeds|bleeds||Number
637344|NCT02492984|Secondary|Number of Infusions Needed to Treat Each New Bleed for On-Demand Treatment|The number of Xyntha infusions administered to treat a bleed was determined. This was calculated by adding the on-demand initial treatment and any on-demand follow-up infusions for the same bleed (same bleed start date/time).|From Day 1 up to participants had received treatment for 6 months or when participants had achieved 50 EDs whichever occurred first.|"Participants with a bleed during the study for which on-demand treatment with Xyntha was administered. The data for this outcome was not planned to be analyzed for the surgical prophylaxis group."||infusions||Standard Deviation|Mean
637345|NCT02492984|Secondary|Response Assessment of On-Demand Treatment of Bleeds|The proportion of infusions (initial and subsequent for a bleed) in each response category (excellent, good, moderate, no response) was reported. Excellent: Definite pain relief and/or improvement in signs of bleeding starting within 8 hours after an infusion, with no additional infusion administered. Good: Definite pain relief and/or improvement in signs of bleeding starting within 8 hours after an infusion, with at least 1 additional infusion administered for complete resolution of the bleeding episode or definite pain relief and/or improvement in signs of bleeding starting after 8 hours following the infusion, with no additional infusion administered. Moderate: Probable or slight improvement starting after 8 hours following the infusion, with at least 1 additional infusion administered for complete resolution of the bleeding episode. No Response: No improvement at all between infusions or during the 24 hour interval following an infusion, or condition worsens.|From Day 1 up to participants had received treatment for 6 months or when participants had achieved 50 EDs whichever occurred first.|"Participants with a bleed during the study for which on-demand treatment with Xyntha was administered. The data for this outcome was not planned to be analyzed for the surgical prophylaxis group."||percentage of infusions|infusions||Number
637357|NCT02491944|Secondary|Tmax for [14C]AZD9291 and it's Metabolites [14C]AZ5104 and [14C]AZ7550|Pharmacokinetic (PK) profile of the IV dose of AZD9291 in terms of the the time to maximum observed plasma concentration (Tmax) for [14C]AZD9291 and it's metabolites [14C]AZ5104 and [14C]AZ7550.|Samples taken pre-dose, during the infusion, immediately at the end of infusion and then at 5, 10, 20, 25 and 30 minutes and 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 42, 66, 114, 162, 210, 330 and 498 hours after the end of the infusion.|PK analysis set included all healthy male subjects who received at least 1 dose of AZD9291 and have at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of AZD9291.||hours||Full Range|Median
641482|NCT02308787|Other Pre-specified|Patients WBC Count Pre-depletion Procedure||Prior to each Spectra Optia Apheresis Procedure|||cells x 10^9/L|Participants|Standard Deviation|Mean
637346|NCT02492984|Secondary|Number of Participants With All Causality Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. An AE was considered treatment emergent if it started for the first time in a participant on or after the first day of active treatment, or the event started before the first day of active treatment but increased in severity during active treatment. AEs included both SAEs and non-serious AEs.|From Day 1 up to 28 calendar days after End of Treatment (participants had received treatment for 6 months or when participants had achieved 50 EDs whichever occurred first).|The safety analysis set was defined as all participants who received at least one dose of Xyntha during the study.||participants|||Number
637347|NCT02492984|Primary|Percentage of Participants With Factor VIII (FVIII) Inhibitors|Percentage of participants with the product medically important event (MIE) (FVIII inhibitor development during the study).|From Day 1 up to 28 calendar days after End of Treatment (participants had received treatment for 6 months or when participants had achieved 50 exposure days [EDs] whichever occurred first).|The safety analysis set was defined as all participants who received at least one dose of Xyntha during the study.||percentage of participants||95% Confidence Interval|Number
637348|NCT02492841|Secondary|Adverse Effects|Name any adverse effects.|1 week, 3 and 6 months|There were no adverse effects in the population studied.||Participants|||Count of Participants
637349|NCT02492841|Primary|Treatment Outcome|vitality test with electric device cold and hot test radiographic evaluation|3 months, 6 moths and 12 months|Intent a preventive treatment against cavities to avoid endodoncies with different treatments and see which one is more effective after 12 months follow up.||Participants|||Count of Participants
637350|NCT02492451|Primary|Pregnancy Rate|ongoing pregnancy rates|12 weeks|||percentage of ongoing pregnancies|||Number
637351|NCT02492165|Primary|Summary of Geometric Mean Titers of Japanese Encephalitis Antibodies Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)|Neutralizing antibodies were measured using a Japanese encephalitis chimeric virus (JE CV) 50% plaque reduction neutralization test (PRNT50).|Day 0 (pre-vaccination) and Day 28 post-vaccination|Geometric mean titers were assessed in the Per Protocol Analysis Set.||Titers (1/dil)||95% Confidence Interval|Geometric Mean
637352|NCT02492165|Primary|Percentage of Participants With Japanese Encephalitis Seroconversion Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)|Neutralizing antibodies were measured using a Japanese encephalitis chimeric virus (JE CV) 50% plaque reduction neutralization test (PRNT50). Seroconversion was defined as participants with a pre-vaccination titer <10 (1/dil) and post-vaccination titer ≥10 (1/dil) or participants with pre vaccination titer ≥10 (1/dil) and a ≥4-fold increase from pre- to post-vaccination.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Seroconversion was assessed in the Per-Protocol Analysis Set.||Percentage of participants|||Number
637353|NCT02492165|Primary|Percentage of Participants With Japanese Encephalitis Seroprotection Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)|Neutralizing antibodies were measured using a Japanese encephalitis chimeric virus (JE CV) 50% plaque reduction neutralization test (PRNT50). Seroprotection was defined as antibody titer levels ≥10 (1/dil).|Day 0 (pre-vaccination) and Day 28 post-vaccination|Seroprotection was assessed in the Per-Protocol Analysis Set.||Percentage of participants|||Number
637354|NCT02492165|Primary|Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)|"Solicited injection-site: ≤ 23 months age: Tenderness, Erythema, and Swelling. For ≥ 2 years age: Pain, Erythema, and Swelling. Solicited systemic reactions: ≤ 23 months age, Fever (temperature) Vomiting, Crying abnormal, Drowsiness, Appetite loss, Irritability, For ≥ 2 years age, Fever (temperature) Headache, Malaise, and Myalgia.
Grade 3: Tenderness, Cries when injected limb is moved; Pain, Incapacitating, unable to perform usual activities or Significant; prevents daily activity (≥ 12 years); Erythema and Swelling (≤23 months to 11 years), ≥50 mm or >100 mm (≥ 12 years).
Grade 3 Fever, > 39.5°C (≤ 23 months) or ≥39.0°C (≥ 2 years); Vomiting, ≥ 6 episodes per 24 hours; Crying abnormal, > 3 hours; Drowsiness, Sleeping most of the time; Appetite loss, Refuses ≥ 3 feeds / meals; Irritability, Inconsolable. Headache, Malaise, and Myalgia, Significant; prevents daily activity."|Day 0 up to Day 14 post-vaccination|Solicited injection site and solicited systemic reactions were assessed in the Safety Analysis Set.||Participants|||Number
637355|NCT02491944|Secondary|CL for [14C]AZD9291|Pharmacokinetic (PK) profile of the IV dose of AZD9291 in terms of total body clearance of drug from plasma after intravascular administration (CL) for [14C]AZD9291.|Samples taken pre-dose, during the infusion, immediately at the end of infusion and then at 5, 10, 20, 25 and 30 minutes and 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 42, 66, 114, 162, 210, 330 and 498 hours after the end of the infusion.|PK analysis set included all healthy male subjects who received at least 1 dose of AZD9291 and have at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of AZD9291.||L/h||Standard Deviation|Mean
637356|NCT02491944|Secondary|t1/2,λz for [14C]AZD9291 and it's Metabolites [14C]AZ5104 and [14C]AZ7550|Pharmacokinetic (PK) profile of the IV dose of AZD9291 in terms of the elimination half life (t1/2,λz) for [14C]AZD9291 and it's metabolites [14C]AZ5104 and [14C]AZ7550.|Samples taken pre-dose, during the infusion, immediately at the end of infusion and then at 5, 10, 20, 25 and 30 minutes and 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 42, 66, 114, 162, 210, 330 and 498 hours after the end of the infusion.|PK analysis set included all healthy male subjects who received at least 1 dose of AZD9291 and have at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of AZD9291.||hours||Standard Deviation|Mean
637419|NCT02489799|Secondary|Iowa Goals of Care Across Study Arms Throughout the Study Period|"This metric enables respondents to verify why they are seeking medical care. The most selected goal at all visits was Cure my medical condition. We have reported the number of participants in each group who selected this goal at each time point."|Enrollment, one week after enrollment, one week after surgery, one month after surgery|At each milestone of data collection, a number of participants were unable to complete the Iowa Goals of Care questionnaire due to one of a number of factors including complicated medical course, attrition, or loss of eligibility.||Participants|||Count of Participants
637358|NCT02491944|Secondary|Cmax for [14C]AZD9291 and it's Metabolites [14C]AZ5104 and [14C]AZ7550|Pharmacokinetic (PK) profile of the IV dose of AZD9291 in terms of the maximum observed plasma concentration (Cmax) for [14C]AZD9291 and it's metabolites [14C]AZ5104 and [14C]AZ7550.|Samples taken pre-dose, during the infusion, immediately at the end of infusion and then at 5, 10, 20, 25 and 30 minutes and 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 42, 66, 114, 162, 210, 330 and 498 hours after the end of the infusion.|PK analysis set included all healthy male subjects who received at least 1 dose of AZD9291 and have at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of AZD9291.||nM*eq||Geometric Coefficient of Variation|Geometric Mean
637359|NCT02491944|Secondary|AUC(0-t) for [14C]AZD9291 and it's Metabolites [14C]AZ5104 and [14C]AZ7550|Pharmacokinetic (PK) profile of the IV dose of AZD9291 in terms of Area under the plasma concentration - time curve (AUC) from time zero to the last quantifiable concentration (AUC 0-t) for [14C]AZD9291 and it's metabolites [14C]AZ5104 and [14C]AZ7550.|Samples taken pre-dose, during the infusion, immediately at the end of infusion and then at 5, 10, 20, 25 and 30 minutes and 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 42, 66, 114, 162, 210, 330 and 498 hours after the end of the infusion.|PK analysis set included all healthy male subjects who received at least 1 dose of AZD9291 and have at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of AZD9291.||nM*eq*h||Geometric Coefficient of Variation|Geometric Mean
637360|NCT02491944|Secondary|AUC(0-120) for [14C]AZD9291 and it's Metabolites [14C]AZ5104 and [14C]AZ7550|Pharmacokinetic (PK) profile of the IV dose of AZD9291 in terms of Area under the plasma concentration - time curve (AUC) from time zero to 120 hours (AUC 0-120) for [14C]AZD9291 and it's metabolites [14C]AZ5104 and [14C]AZ7550.|Samples taken pre-dose, during the infusion, immediately at the end of infusion and then at 5, 10, 20, 25 and 30 minutes and 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 42, 66, 114, 162, 210, 330 and 498 hours after the end of the infusion.|PK analysis set included all healthy male subjects who received at least 1 dose of AZD9291 and have at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of AZD9291.||nM*eq*h||Geometric Coefficient of Variation|Geometric Mean
637361|NCT02491944|Secondary|AUC(0-24) for [14C]AZD9291 and it's Metabolites [14C]AZ5104 and [14C]AZ7550|Pharmacokinetic (PK) profile of the IV dose of AZD9291 in terms of Area under the plasma concentration - time curve (AUC) from time zero to 24 hours (AUC 0-24) for [14C]AZD9291 and it's metabolites [14C]AZ5104 and [14C]AZ7550.|Samples taken pre-dose, during the infusion, immediately at the end of infusion and then at 5, 10, 20, 25 and 30 minutes and 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 42, 66, 114, 162, 210, 330 and 498 hours after the end of the infusion.|PK analysis set included all healthy male subjects who received at least 1 dose of AZD9291 and have at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of AZD9291.||nM*eq*h||Geometric Coefficient of Variation|Geometric Mean
637362|NCT02491944|Secondary|AUC for [14C]AZD9291 and it's Metabolites [14C]AZ5104 and [14C]AZ7550|Pharmacokinetic (PK) profile of the IV dose of AZD9291 in terms of Area under the plasma concentration - time curve (AUC) from zero to infinity for [14C]AZD9291 and it's metabolites [14C]AZ5104 and [14C]AZ7550.|Samples taken pre-dose, during the infusion, immediately at the end of infusion and then at 5, 10, 20, 25 and 30 minutes and 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 42, 66, 114, 162, 210, 330 and 498 hours after the end of the infusion.|PK analysis set included all healthy male subjects who received at least 1 dose of AZD9291 and have at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of AZD9291.||nM*eq*h||Geometric Coefficient of Variation|Geometric Mean
637363|NCT02491944|Secondary|CL/F for AZD9291|PK profile of the oral dose of AZD9291 in terms of apparent total body clearance of drug from plasma after extravascular administration(CL/F) for AZD9291.|Samples taken at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 and 504 hours post-dose.|PK analysis set included all healthy male subjects who received at least 1 dose of AZD9291 and have at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of AZD9291.||L/h||Standard Deviation|Mean
637364|NCT02491944|Secondary|t1/2,λz for AZD9291 and it's Metabolites AZ5104 and AZ7550|PK profile of the oral dose of AZD9291 in terms of the elimination half life (t1/2,λz) for AZD9291 and it's metabolites AZ5104 and AZ7550.|Samples taken at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 and 504 hours post-dose.|PK analysis set included all healthy male subjects who received at least 1 dose of AZD9291 and have at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of AZD9291.||hours||Standard Deviation|Mean
637365|NCT02491944|Secondary|Tmax for AZD9291 and it's Metabolites AZ5104 and AZ7550|PK profile of the oral dose of AZD9291 in terms of the time to maximum observed plasma concentration (Tmax) for AZD9291 and it's metabolites AZ5104 and AZ7550.|Samples taken at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 and 504 hours post-dose.|PK analysis set included all healthy male subjects who received at least 1 dose of AZD9291 and have at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of AZD9291.||hours||Full Range|Median
637366|NCT02491944|Secondary|Cmax for AZD9291 and it's Metabolites AZ5104 and AZ7550|PK profile of the oral dose of AZD9291 in terms of the maximum observed plasma concentration (Cmax) for AZD9291 and it's metabolites AZ5104 and AZ7550.|Samples taken at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 and 504 hours post-dose.|PK analysis set included all healthy male subjects who received at least 1 dose of AZD9291 and have at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of AZD9291.||nM||Geometric Coefficient of Variation|Geometric Mean
637367|NCT02491944|Secondary|AUC(0-t) for AZD9291 and it's Metabolites AZ5104 and AZ7550|Pharmacokinetic (PK) profile of the oral dose of AZD9291 in terms of Area under the plasma concentration - time curve (AUC) from time zero to the last quantifiable concentration (AUC 0-t) for AZD9291 and it's metabolites AZ5104 and AZ7550.|Samples taken at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 and 504 hours post-dose.|PK analysis set included all healthy male subjects who received at least 1 dose of AZD9291 and have at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of AZD9291.||nM*h||Geometric Coefficient of Variation|Geometric Mean
641938|NCT02288273|Secondary|Average of Change in 24-hour Mean Weighted Glucose From Baseline to Week 4 and Baseline to Week 10||Week 4 and Week 10|||mg/dL||Standard Error|Least Squares Mean
637368|NCT02491944|Secondary|AUC(0-120) for AZD9291 and it's Metabolites AZ5104 and AZ7550|Pharmacokinetic (PK) profile of the oral dose of AZD9291 in terms of Area under the plasma concentration - time curve (AUC) from time zero to 120 hours (AUC 0-120) for AZD9291 and it's metabolites AZ5104 and AZ7550.|Samples taken at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 and 504 hours post-dose.|PK analysis set included all healthy male subjects who received at least 1 dose of AZD9291 and have at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of AZD9291.||nM*h||Geometric Coefficient of Variation|Geometric Mean
637369|NCT02491944|Secondary|AUC(0-24) for AZD9291 and it's Metabolites AZ5104 and AZ7550|Pharmacokinetic (PK) profile of the oral dose of AZD9291 in terms of Area under the plasma concentration - time curve (AUC) from time zero to 24 hours (AUC 0-24) for AZD9291 and it's metabolites AZ5104 and AZ7550.|Samples taken at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 and 504 hours post-dose.|PK analysis set included all healthy male subjects who received at least 1 dose of AZD9291 and have at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of AZD9291.||nM*h||Geometric Coefficient of Variation|Geometric Mean
637370|NCT02491944|Secondary|AUC for AZD9291 and it's Metabolites AZ5104 and AZ7550|Pharmacokinetic (PK) profile of the oral dose of AZD9291 in terms of Area under the plasma concentration - time curve (AUC) from zero to infinity for AZD9291 and it's metabolites AZ5104 and AZ7550.|Samples taken at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 and 504 hours post-dose.|PK analysis set included all healthy male subjects who received at least 1 dose of AZD9291 and have at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of AZD9291.||nM*h||Geometric Coefficient of Variation|Geometric Mean
637371|NCT02491944|Primary|Absolute Oral Bioavailability|Absolute bioavailability of AZD9291 will be calculated from area under the plasma concentration versus time curve (AUC) of the oral dose of AZD9291 / AUC of the IV dose of [14C]AZD9291 x IV dose/Oral dose x 100|Samples taken at pre-dose, 1, 2, 3, 4, 5:45, 5:52, 6, 6:05, 6:10, 6:20, 6:25, 6:30, 7, 8, 9, 10, 12, 14, 16, 18, 24, 30, 48, 72, 120, 168, 216, 336 and 504 hours relative to the oral dose.|PK analysis set included all healthy male subjects who received at least 1 dose of AZD9291 and have at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of AZD9291.||Percentage||90% Confidence Interval|Geometric Mean
637372|NCT02491892|Secondary|Number of Participants Experiencing a Drop in Left Ventricular Ejection Fraction (LVEF) to a Value of Less Than 50%|Echocardiography was performed to determine LVEF, defined as the volume of blood pumped from the left ventricle as a percentage of end-diastolic volume. Theoretically, LVEF may range from 0 to 100%. The number of participants experiencing a drop in LVEF greater than or equal to (≥) 10 or 15 percentage points to a final LVEF of less than (<) 50% is reported here.|Up to approximately 1 year (at Baseline; at the end of Cycles 2, 4, 8, 12, and 16; and up to 7 weeks following the last infusion)|Safety Population.||participants|||Number
637373|NCT02491892|Secondary|Mean Residence Time (MRT) of Pertuzumab|Serum samples were obtained for PK assessment using a receptor-binding ELISA. Pertuzumab concentrations at each collection point were used to determine the MRT by non-compartmental analysis. The derived value was averaged among all participants and expressed in days.|Pre-dose and within 15 minutes of the end of infusion on Day 1 of each cycle, and on Days 8 and 15 of Cycles 1 and 2|ITT Population. Participants with missing PK data were excluded from the analysis.||days||Standard Deviation|Mean
637374|NCT02491892|Secondary|Volume of Distribution at Steady State (Vss) of Pertuzumab|Serum samples were obtained for PK assessment using a receptor-binding ELISA. Pertuzumab concentrations at each collection point were used to determine the Vss by non-compartmental analysis, defined as the theoretical volume at which the total amount of pertuzumab would be uniformly distributed to produce the desired concentration. The derived value was averaged among all participants and expressed in milliliters (mL).|Pre-dose and within 15 minutes of the end of infusion on Day 1 of each cycle, and on Days 8 and 15 of Cycles 1 and 2|ITT Population. Participants with missing PK data were excluded from the analysis.||mL||Standard Deviation|Mean
637375|NCT02491892|Secondary|Systemic Clearance (CL) of Pertuzumab|Serum samples were obtained for PK assessment using a receptor-binding ELISA. Pertuzumab concentrations at each collection point were used to determine CL by non-compartmental analysis, defined as the rate at which pertuzumab was removed from the body. The derived value was averaged among all participants and expressed in milliliters per day (mL/day).|Pre-dose and within 15 minutes of the end of infusion on Day 1 of each cycle, and on Days 8 and 15 of Cycles 1 and 2|ITT Population. Participants with missing PK data were excluded from the analysis.||mL/day||Standard Deviation|Mean
637376|NCT02491892|Secondary|Area Under the Concentration-Time Curve (AUC) of Pertuzumab|Serum samples were obtained for PK assessment using a receptor-binding ELISA. Pertuzumab concentrations at each collection point were used to determine AUC to the last measurable observation (AUClast) and AUC extrapolated to infinity (AUCinf) by non-compartmental analysis. The derived values were averaged among all participants and expressed in days by micrograms per milliliter (days*mcg/mL).|Pre-dose and within 15 minutes of the end of infusion on Day 1 of each cycle, and on Days 8 and 15 of Cycles 1 and 2|ITT Population. Participants with missing PK data were excluded from the analysis, and the number of participants analyzed (n) is presented here.||days*mcg/mL||Standard Deviation|Mean
637377|NCT02491892|Secondary|Time to Maximum Plasma Concentration (Tmax) of Pertuzumab|Serum samples were obtained for PK assessment using a receptor-binding ELISA. The time of maximum observed pertuzumab concentration across all collection points was documented. Tmax was averaged among all participants and expressed in days.|Pre-dose and within 15 minutes of the end of infusion on Day 1 of each cycle, and on Days 8 and 15 of Cycles 1 and 2|ITT Population. Participants with missing PK data were excluded from the analysis.||days||Full Range|Median
637378|NCT02491892|Secondary|Maximum Plasma Concentration (Cmax) of Pertuzumab|Serum samples were obtained for PK assessment using a receptor-binding ELISA. The maximum observed pertuzumab concentration across all collection points was documented. Cmax was averaged among all participants and expressed in micrograms per milliliter (mcg/mL).|Pre-dose and within 15 minutes of the end of infusion on Day 1 of each cycle, and on Days 8 and 15 of Cycles 1 and 2|ITT Population. Participants with missing PK data were excluded from the analysis.||mcg/mL||Standard Deviation|Mean
637886|NCT02467075|Secondary|Subjects With AKI (Acute Kidney Injury), Stage 1 or Other Definition|Stage I AKI, traditional CIN definitions or other definitions of AKI (acute kidney injury) at lower levels of severity|48-72 hours|||Participants|||Count of Participants
637379|NCT02491892|Secondary|Apparent Half-Life (t1/2) of Pertuzumab|Serum samples were obtained for pharmacokinetic (PK) assessment using a receptor-binding, enzyme-linked immunosorbent assay (ELISA). Pertuzumab concentrations at each collection point were used to determine the apparent t1/2 by non-compartmental analysis, defined as the time elapsed for pertuzumab concentrations to decrease by 50%. The derived value was averaged among all participants and expressed in days.|Pre-dose and within 15 minutes of the end of infusion on Day 1 of each cycle, and on Days 8 and 15 of Cycles 1 and 2|ITT Population. Participants with missing PK data were excluded from the analysis.||days||Standard Deviation|Mean
637380|NCT02491892|Secondary|Percentage of Participants Achieving a Best Overall Response of SD|Objective tumor response was assessed using RECIST. SD was defined as neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for PD. The percentage of participants achieving a best overall response of SD was calculated as [number of participants meeting the above criteria divided by the number analyzed] multiplied by 100.|Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)|ITT Population.||percentage of participants|||Number
637381|NCT02491892|Secondary|Overall Survival|Overall survival was defined as the time from treatment start to death. Participants who did not die during follow-up were to be censored from the last known alive date. Overall survival was to be estimated using Kaplan-Meier.|Up to approximately 2 years (from start of treatment until death)|Median survival was not reached because the study program was terminated early. Analysis of the incomplete data set was not performed because it could potentially produce skewed or statistically irrelevant data.|||||
637382|NCT02491892|Secondary|Percentage of Participants Who Died|The percentage of participants who died was calculated as [number of participants with event divided by the number analyzed] multiplied by 100.|Up to approximately 2 years (from start of treatment until death)|Safety Population: All randomized participants who received at least one dose of pertuzumab and had at least one post-baseline safety assessment.||percentage of participants|||Number
637383|NCT02491892|Secondary|Time to Treatment Failure|Objective tumor response was assessed using RECIST. PD was defined as the appearance of new lesion(s) or at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum obtained at Screening or during treatment. Time to treatment failure was defined as the time from treatment start to PD or early withdrawal from the study for death, toxicity, refusal/noncompliance, insufficient therapeutic response, or failure to return. Participants who did not experience PD or who did not withdraw from the study early were censored from the last tumor assessment. Time to treatment failure was estimated using Kaplan-Meier and expressed in weeks.|Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)|ITT Population.||weeks||Full Range|Median
637384|NCT02491892|Secondary|Number of Participants Who Experienced PD or Withdrew From the Study Early|Objective tumor response was assessed using RECIST. PD was defined as the appearance of new lesion(s) or at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum obtained at Screening or during treatment.|Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)|ITT Population.||participants|||Number
637385|NCT02491892|Secondary|Time to Progression|Objective tumor response was assessed using RECIST. PD was defined as the appearance of new lesion(s) or at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum obtained at Screening or during treatment. Participants who withdrew from the study early for insufficient therapeutic response without tumor assessment for PD were also included within the definition of PD. Time to progression was defined as the time from treatment start to PD or death. Participants who did not experience PD or death were censored from the last tumor assessment. Time to progression was estimated using Kaplan-Meier and expressed in weeks.|Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)|ITT Population.||weeks||Full Range|Median
637386|NCT02491892|Secondary|Number of Participants Who Experienced PD or Death|Objective tumor response was assessed using RECIST. PD was defined as the appearance of new lesion(s) or at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum obtained at Screening or during treatment. Participants who withdrew from the study early for insufficient therapeutic response without tumor assessment for PD were also included within the definition of PD.|Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)|ITT Population.||participants|||Number
637387|NCT02491892|Secondary|Duration of Response Among Participants Achieving a Best Overall Response of Confirmed CR|Objective tumor response was assessed using RECIST. Confirmed CR was defined as the disappearance of all target lesions. Response was to be confirmed at follow-up assessment completed within 4 weeks of the first documented response. Duration of response was defined as the time from first documented response (ie, CR) to PD or death. Participants who did not experience PD or death were to be censored from the last tumor assessment. Duration of response was to be estimated using Kaplan-Meier.|Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)|ITT Population.||weeks||Full Range|Median
637388|NCT02491892|Secondary|Percentage of Participants Achieving a Best Overall Response of Confirmed CR|Objective tumor response was assessed using RECIST. Confirmed CR was defined as the disappearance of all target lesions. Response was to be confirmed at follow-up assessment completed within 4 weeks of the first documented response. The percentage of participants achieving a best overall response of CR was calculated as [number of participants meeting the above criteria divided by the number analyzed] multiplied by 100.|Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)|ITT Population.||percentage of participants|||Number
637489|NCT02484911|Primary|Proportion of Participants Receiving MEC With Complete Response in Overall Phase|"Overall phase was defined as 0 to 120 hours following initiation of chemotherapy.
Complete response was defined as no vomiting with no rescue therapy."|0 to 120 hours|FAS (full analysis set) patient population was used for all efficacy evaluations and included patients who (1) received Moderate Emetogenic Chemotherapy (MEC), (2) took a dose of study drug, and (3) completed treatment.||Participants|||Count of Participants
637389|NCT02491892|Secondary|Duration of Response Among Participants Achieving a Best Overall Response of Confirmed CR or PR|Objective tumor response was assessed using RECIST. Confirmed CR was defined as the disappearance of all target lesions, and confirmed PR was defined as at least at 30% decrease in the sum of the longest diameters of target lesions. Response was to be confirmed at follow-up assessment completed within 4 weeks of the first documented response. Duration of response was defined as the time from first documented response (ie, CR or PR) to PD or death. Participants who did not experience PD or death were censored from the last tumor assessment. Duration of response was estimated using Kaplan-Meier and expressed in weeks.|Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)|ITT Population.||weeks||Full Range|Median
637390|NCT02491892|Secondary|Time to Response Among Participants Achieving a Best Overall Response of Confirmed CR or PR|Objective tumor response was assessed using RECIST. Confirmed CR was defined as the disappearance of all target lesions, and confirmed PR was defined as at least at 30% decrease in the sum of the longest diameters of target lesions. Response was to be confirmed at follow-up assessment completed within 4 weeks of the first documented response. Time to response was defined as the time from treatment start to first documented response (ie, CR or PR). Participants with stable disease (SD) were censored from the last tumor assessment, and those with progressive disease (PD) or death were assigned an artificial censoring time of 1000 days. Time to response was estimated using Kaplan-Meier and expressed in weeks.|Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)|ITT Population.||weeks||Full Range|Median
637391|NCT02491892|Primary|Percentage of Participants Achieving a Best Overall Response of Confirmed Complete Response (CR) or Partial Response (PR)|Objective tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR was defined as the disappearance of all target lesions, and confirmed PR was defined as at least at 30 percent (%) decrease in the sum of the longest diameters of target lesions. Response was to be confirmed at follow-up assessment completed within 4 weeks of the first documented response. The percentage of participants achieving a best overall response of CR or PR was calculated as [number of participants meeting the above criteria divided by the number analyzed] multiplied by 100.|Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)|ITT Population.||percentage of participants|||Number
637392|NCT02490670|Primary|Pharmacokinetics: Maximum Concentration (Cmax) of Cephalexin Following a Single Dose||Predose,0.167, 0.333, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, and 7 hours after drug administration in each period|All randomized participants who received at least one dose of study drug.||Microgram per milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
637393|NCT02490670|Primary|Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Cephalexin Following a Single Dose||Predose, 0.167, 0.333, 0.5, 0.75, 1, 1.25, 1.500, 2, 2.5, 3, 3.5, 4, 5, 6, and 7 hours after drug administration in each period|All randomized participants who received at least one dose of study drug.||hour*microgram per milliliter (h*μg/mL)||Geometric Coefficient of Variation|Geometric Mean
637394|NCT02490475|Secondary|Number of Participants With DLTs|DLTs were defined as any of the following: 1) Any non-hematological toxicity greter than or equal to (≥) Grade 3 according t0 CTCAE version 3.0 except for fever, chills and flu-like symptoms, in spite of adequate toxicity management, 2) Grade 4 neutropenia lasting greater than (>) 7 days, 3) Febrile neutropenia, 4) Thrombocytopenia Grade 4 or any thrombocytopenia requiring platelet transfusion or 5) Any subjectively intolerable toxicity felt by the investigator to be related to either one of the compounds.|From Baseline until 4 weeks after the end of treatment|Safety Population||number of participants|||Number
637395|NCT02490475|Secondary|CL for Docetaxel Alone and in Combination With Pertuzumab|Clearance (expressed as volume/time) describes the removal of drug from a volume of plasma in a given unit of time (drug loss from the body). It is measured as milliliters per hour per meter squared (mL/h/m^2). The pharmacokinetic parameters were derived by non-compartmental methods using WinNonLin version 5.0.1.|Cycles 1 and 2: Pre-dose, 30 and 55 minutes during dosing, 15 minutes, 30 minutes, 1, 2, 4, 8, and 23 hours Post-dose|ITT population; Data from Cohort 2 (docetaxel 75 mg/m^2 and pertuzumab 1050 mg) were excluded because there were only 2 participant data. It was planned not to report PK data, if less than or equal to 2 participants were analyzed. n= number of participants analyzed at the specified cycle.||mL/h/m^2||Standard Deviation|Mean
637396|NCT02490475|Secondary|Vss for Docetaxel Alone and in Combination With Pertuzumab|The volume of distribution at steady state (Vss), also known as apparent volume of distribution, is a pharmacological, theoretical volume that the total amount of administered drug would have to occupy (if it were uniformly distributed), to provide the same concentration as it currently is in blood plasma. The pharmacokinetic parameters were derived by non-compartmental methods using WinNonLin version 5.0.1.|Cycles 1 and 2: Pre-dose, 30 and 55 minutes during dosing, 15 minutes, 30 minutes, 1, 2, 4, 8, and 23 hours Post-dose|ITT population; Data from Cohort 2 (docetaxel 75 mg/m^2 and pertuzumab 1050 mg) were excluded because there were only 2 participant data. It was planned not to report PK data, if less than or equal to 2 participants were analyzed. n= number of participants analyzed at the specified cycle.||mL/m^2||Standard Deviation|Mean
637397|NCT02490475|Secondary|AUC(0-∞) for Docetaxel Alone and in Combination With Pertuzumab|The AUC0-infinity is calculated from time 0 (prior to administration of medication) to infinity (the time of complete elimination of the drug). The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. AUC is measured as ng*h/mL. The pharmacokinetic parameters were derived by non-compartmental methods using WinNonLin version 5.0.1.|Cycles 1 and 2: Pre-dose, 30 and 55 minutes during dosing, 15 minutes, 30 minutes, 1, 2, 4, 8, and 23 hours Post-dose|ITT population; Data from Cohort 2 (docetaxel 75 mg/m^2 and pertuzumab 1050 mg) were excluded because there were only 2 participant data. It was planned not to report PK data, if less than or equal to 2 participants were analyzed. n= number of participants analyzed at the specified cycle.||ng*h/mL||Standard Deviation|Mean
637490|NCT02484911|Primary|Proportion of Participants Receiving HEC With Complete Response in Overall Phase|"Overall phase was defined as 0 to 120 hours following initiation of chemotherapy.
Complete response was defined as no vomiting with no rescue therapy."|0 to 120 hours|FAS (full analysis set) patient population was used for all efficacy evaluations and included patients who (1) received High Emetogenic Chemotherapy (HEC), (2) took a dose of study drug, and (3) completed treatment.||Participants|||Count of Participants
637398|NCT02490475|Secondary|Cmax for Docetaxel Alone and in Combination With Pertuzumab|Cmax refers to the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administrated and prior to the administration of a second dose and is measures as nanograms per milliliter (ng/mL). The pharmacokinetic parameters were derived by non-compartmental methods using WinNonLin version 5.0.1.|Cycles 1 and 2: Pre-dose, 30 and 55 minutes during dosing, 15 minutes, 30 minutes, 1, 2, 4, 8, and 23 hours Post-dose|ITT population; Data from Cohort 2 (docetaxel 75 mg/m^2 and pertuzumab 1050 mg) were excluded because there were only 2 participant data. It was planned not to report PK data, if less than or equal to 2 participants were analyzed. n= number of participants analyzed at the specified cycle.||ng/mL||Standard Deviation|Mean
637399|NCT02490475|Secondary|Tmax for Docetaxel Alone and in Combination With Pertuzumab|"Tmax is defined as the time after administration of a drug when the maximum plasma concentration is reached; Data for docetaxel alone arms were analyzed for the timepoints on Day 1 prior to the administration of pertuzumab. When the rate of absorption equals the rate of elimination. The pharmacokinetic parameters were derived by non-compartmental methods using WinNonLin version 5.0.1."|Cycles 1 and 2: Pre-dose, 30 and 55 minutes during dosing, 15 minutes, 30 minutes, 1, 2, 4, 8, and 23 hours Post-dose|ITT population; Data from Cohort 2 (docetaxel 75 mg/m^2 and pertuzumab 1050 mg) were excluded because there were only 2 participant data. It was planned not to report PK data, if less than or equal to 2 participants were analyzed. n= number of participants analyzed at the specified cycle.||days||Full Range|Median
637400|NCT02490475|Secondary|t1/2 for Docetaxel Alone and in Combination With Pertuzumab|"The biological half-life or terminal half-life of docetaxel is the time in hours it takes for it to lose half of its pharmacologic activity. Data for docetaxel alone arms were analyzed for the timepoints on Day 1 prior to the administration of pertuzumab. The pharmacokinetic parameters were derived by non-compartmental methods using WinNonLin version 5.0.1."|Cycles 1 and 2: Pre-dose, 30 and 55 minutes during dosing, 15 minutes, 30 minutes, 1, 2, 4, 8, and 23 hours Post-dose|ITT population; Data from Cohort 2 (docetaxel 75 mg/m^2 and pertuzumab 1050 mg) were excluded because there were only 2 participant data. It was planned not to report PK data, if less than or equal to 2 participants were analyzed. n= number of participants analyzed at the specified cycle.||days||Full Range|Median
637401|NCT02490475|Secondary|Percentage of Participants With Decrease in Left Ventricular Ejection Fraction (LVEF) by Category of Decrease and Timepoint|Ejection fraction (EF) is the fraction of outbound blood pumped from the heart with each heartbeat. It is commonly measured by echocardiogram and serves as a general measure of a person's cardiac function. Changes in LVEF were assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 criteria. The decrease in LVEF has been categorized as follows: A) Increase, no change, decrease from baseline less than (<) 10%; B) Absolute value <50% and decrease from baseline greater than or equal to (≥) 10%; C) Absolute value <50% and decrease from baseline≥15% ; D) Other. If participants withdrew due to insufficient therapeutic response or death and had no tumor measurements at the final visit, they were counted under progressive disease for final visit.|Baseline, Weeks 7(Cycle 2), 13 (Cycle 4) and Final Visit Up to Week 22|ITT population; n = number of participants still receiving treatment at the specified cycle for each arm, respectively.||percentage of participants|||Number
637402|NCT02490475|Secondary|Percentage of Participants by Best Overall Response Using Response Evaluation Criteria in Solid Tumors (RECIST) Criteria|Best Overall response was evaluated as Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD). CR: complete disappearance of all target lesions. PR: at least a 30 percent (%) decrease in the sum of the longest diameters. SD: neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum of the longest diameters since the treatment started. PD: at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of the longest diameters of the target lesions recorded since the treatment started, including screening, or the appearance of one or more new lesions. If participants withdrew due to insufficient therapeutic response or death and had no tumor measurements at the final visit, they were counted under progressive disease for final visit.|Weeks 7 (Cycle 2),13 (Cycle 4) and Final Visit Up to 22 weeks|ITT population; n = number of participants still receiving treatment at the specified cycle for each arm respectively.||percentage of participants|||Number
637403|NCT02490475|Secondary|Mean Residence Time (MRT) of Pertuzumab|MRT is the average time that pertuzumab is present in the systemic circulation and is measured in days.|Cycle1: Day 2 Pre-dose and 15 minutes, 1.5, 4 and 8 hours Post-dose, and Days 3, 6, 9 and 16; Cycle 2: Day 1 Pre-dose and 15 minutes Post-dose on Days 1, 8, 15 and 22|"ITT population; Participants in any cohort infused with the specified dose of pertuzumab were included in analysis.
n = number of participants analyzed at the specified timepoint for each arm, respectively."||days||Standard Deviation|Mean
637404|NCT02490475|Secondary|Volume of Distribution (Vz) at Steady State of Pertuzumab in Combination With Docetaxel|The volume of distribution at steady state (Vz), also known as apparent volume of distribution, is a pharmacological, theoretical volume that the total amount of administered drug would have to occupy (if it were uniformly distributed), to provide the same concentration as it currently is in blood plasma.|Cycle1: Day 2 Pre-dose and 15 minutes, 1.5, 4 and 8 hours Post-dose, and Days 3, 6, 9 and 16; Cycle 2: Day 1 Pre-dose and 15 minutes Post-dose on Days 1, 8, 15 and 22|"ITT population; Participants in any cohort infused with the specified dose of pertuzumab were included in analysis.
n = number of participants analyzed at the specified timepoint for each arm, respectively."||mL||Standard Deviation|Mean
637405|NCT02490475|Secondary|Clearance (Cl) of Pertuzimab in Combination With Docetaxel|Clearance (expressed as volume/time) describes the removal of drug from a volume of plasma in a given unit of time (drug loss from the body). It is measured as milliliters per day (mL/day).|Cycle1: Day 2 Pre-dose and 15 minutes, 1.5, 4 and 8 hours Post-dose, and Days 3, 6, 9 and 16; Cycle 2: Day 1 Pre-dose and 15 minutes Post-dose on Days 1, 8, 15 and 22|"ITT population; Participants in any cohort infused with the specified dose of pertuzumab were included in analysis.
n = number of participants analyzed at the specified timepoint for each arm, respectively."||mL/day||Standard Deviation|Mean
637491|NCT02484898|Primary|Diagnostic Yield of the SEEQ™ MCT/ECM System||120 Days|Subjects prescribed the SEEQ™ MCT/ECM monitoring for the detection of non-lethal cardiac arrhythmias||percentage of subjects with CRA||95% Confidence Interval|Number
639654|NCT02387554|Primary|AUClast|AUClast(Area under the curve to the last measurable concentration)|0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr|||Ratio(Comb/Alone)||90% Confidence Interval|Geometric Mean
637406|NCT02490475|Secondary|AUC From Time Zero to Infinity (AUC [0-infinity]) for Pertuzumab in Combination With Docetaxel|The AUC0-infinity is calculated from time 0 (prior to administration of medication) to infinity (the time of complete elimination of the drug). The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. AUC is measured as μg*day/mL.|Cycle1: Day 2 Pre-dose and 15 minutes, 1.5, 4 and 8 hours Post-dose, and Days 3, 6, 9 and 16; Cycle 2: Day 1 Pre-dose and 15 minutes Post-dose on Days 1, 8, 15 and 22|"ITT population; Participants in any cohort infused with the specified dose of pertuzumab were included in analysis.
n = number of participants analyzed at the specified timepoint for each arm, respectively."||μg*day/mL||Standard Deviation|Mean
637407|NCT02490475|Secondary|Area Under the Concentration Curve From Time Zero to the Last Visit (AUC [0-last]) for Pertuzumab in Combination With Docetaxel|The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC0-last is calculated from time 0 (prior to administration of medication) to last measured data point. The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. AUC is measured as micrograms times days per milliliter (μg*day/mL).|Cycle1: Day 2 Pre-dose and 15 minutes, 1.5, 4 and 8 hours Post-dose, and Days 3, 6, 9 and 16; Cycle 2: Day 1 Pre-dose and 15 minutes Post-dose on Days 1, 8, 15 and 22|"ITT population; Participants in any cohort infused with the specified dose of pertuzumab were included in analysis.
n = number of participants analyzed at the specified timepoint for each arm, respectively."||μg*day/mL||Standard Deviation|Mean
637408|NCT02490475|Secondary|Maximum Observed Plasma Concentration (Cmax) for Pertuzumab in Combination With Docetaxel|Cmax refers to the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administrated and prior to the administration of a second dose and is measures as micrograms per milliliter (μg/mL).|Cycle1: Day 2 Pre-dose and 15 minutes, 1.5, 4 and 8 hours Post-dose, and Days 3, 6, 9 and 16; Cycle 2: Day 1 Pre-dose and 15 minutes Post-dose on Days 1, 8, 15 and 22|ITT population; Participants in any cohort infused with the specified dose of pertuzumab were included in analysis. n = number of participants analyzed at the specified timepoint for each arm, respectively.||μg/mL||Standard Deviation|Mean
637409|NCT02490475|Secondary|Plasma Decay Half Life (t1/2) for Pertuzumab in Combination With Docetaxel|The biological half-life or terminal half-life of pertuzumab is the time in days it takes for it to lose half of its pharmacologic activity.|Cycle1: Day 2 Pre-dose and 15 minutes, 1.5, 4 and 8 hours Post-dose, and Days 3, 6, 9 and 16; Cycle 2: Day 1 Pre-dose and 15 minutes Post-dose on Days 1, 8, 15 and 22|ITT population; Participants in any cohort infused with the specified dose of pertuzumab were included in analysis. number (n) equals (=) number of participants analyzed at the specified timepoint for each arm, respectively.||days||Full Range|Median
637410|NCT02490475|Primary|Maximum Tolerated Dose (MTD) of Docetaxel in Combination of Pertuzumab|A prior dose level was defined as an MTD if at a certain dose level, there were greater than or equal to (≥) 2 out of 6 participants who had Dose Limiting Toxicities (DLTs). If there were no DLTs or DLTs were seen in less than (<) 2 participants in the highest dose level, that was considered as MTD. Participants received escalating doses of docetaxel and pertuzumab until DLTs were observed. DLTs were defined as any of the following: 1) Any non-hematological toxicity ≥ Grade 3 according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 except for fever, chills and flu-like symptoms, in spite of adequate toxicity management, 2) Grade 4 neutropenia lasting greater than (>) 7 days, 3) Febrile neutropenia, 4) Thrombocytopenia Grade 4 or any thrombocytopenia requiring platelet transfusion or 5) Any subjectively intolerable toxicity felt by the investigator to be related to either one of the compounds.|Cycle 1 Up to Day 15|Safety Population: included all participants who received any amount of study medication and who had at least one post-baseline safety follow-up.||mg/m^2|||Number
637411|NCT02490293|Secondary|Duration of Hospitalization|the duration between the operation day and the day of discharge|participants will be followed for the duration of hospital stay, an expected average of 2 days|||days||Standard Deviation|Mean
637412|NCT02490293|Primary|Number of Participants With Infectious Postoperative Complications|Incidence of infectious postoperative complications in patients who underwent a laparoscopic cholecystectomy due to grade I Tokyo guidelines for acute cholecystitis or grade II Tokyo guidelines for acute cholecystitis except the evidence of gallbladder perforation, with antibiotics or placebo|30 days|||Participants|||Count of Participants
637413|NCT02489799|Secondary|Prevalence of Participants Who Acknowledge Having a Conversation With Their Surrogate Decision Maker Regarding Advance Care Planning Across Study Arms Throughout the Study Period|This tracks which participants report having had an advance care planning-related conversation with their surrogate decision maker.|Enrollment, one month after surgery|This question was only asked to participants who reported having designated a medical decision maker.||Participants|||Count of Participants
637414|NCT02489799|Secondary|Prevalence of Participants Who Acknowledge Having Named a Surrogate Decision Maker Across Study Arms Throughout the Study Period|This tracks which participants report having named a surrogate decision maker|Enrollment, one month after surgery|At each milestone of data collection, a number of participants were unable to complete the HADS questionnaire due to one of a number of factors including complicated medical course, attrition, or loss of eligibility.||Participants|||Count of Participants
637415|NCT02489799|Secondary|Patient and Provider Satisfaction Scores Across Study Arms|The satisfaction score, as the sum of the scores of six questions (all in Likert scale), ranges from 6 to 30, with a higher score indicating higher level of satisfaction.|One week after enrollment|In two instances, the surgeon was unable to complete the satisfaction scale. This explains why there are fewer surgeon perceptions reported than patients.||units on a scale||Standard Deviation|Mean
637416|NCT02489799|Secondary|Recommendation of the Video to Others Across Study Arms|This Likert scale evaluates respondent beliefs about whether they would recommend the video to others.|One week after enrollment|||Participants|||Count of Participants
637417|NCT02489799|Secondary|Comfort With the Video Across Study Arms|This Likert scale evaluates respondent beliefs about their comfort in viewing the video.|One week after enrollment|||Participants|||Count of Participants
637418|NCT02489799|Secondary|Helpfulness of the Video Across Study Arms|This Likert scale evaluates respondent beliefs about the helpfulness of the video.|One week after enrollment|||Participants|||Count of Participants
640957|NCT02327429|Primary|Change in Carbohydrate Intake (3-day Food Record)|Intake assessed pre-post intervention using a 3-day food record|12 weeks|||percentage of total energy||Standard Deviation|Mean
637420|NCT02489799|Secondary|Hospital Anxiety and Depression Scores Across Study Arms Throughout the Study Period|This validated metric consists of two sub scales: one for symptoms of anxiety, and the other for symptoms of depression. Each subscale, consisting of seven questions, results in a score ranging from 0, indicating no distress, to 21, indicating maximum distress; a score higher than 7 indicates clinically meaningful anxiety or depression. Overall HADS scores, encompassing both subscales, results in a total score of 0 (no mood symptoms ) to 42 (maximal mood symptoms).|Enrollment, one week after enrollment, one week after surgery, one month after surgery|At each milestone of data collection, a number of participants were unable to complete the HADS questionnaire due to one of a number of factors including complicated medical course, attrition, or loss of eligibility.||units on a scale||Standard Deviation|Mean
637421|NCT02489799|Primary|Measured Patient Centeredness in the Presurgical Consent Visit|The RIAS scoring system using an audio-recording of a conversation to evaluate the nature of the conversation between surgeon and patient. The patient-centeredness summary score is a ratio of statements that reflect the psychosocial and socio-emotional elements of exchange about the lived illness experience of patients relative to statements that reflect a more biomedical and disease focused perspective. This score reflects the encounter as a whole, rather than an individual’s dialogue. A value greater than one indicates a more patient-centered encounter; whereas, a value less than one indicates a more biomedical encounter.|Approximately one week after study enrollment.|Audio recordings of a presurgical consent visit conversation between a surgeon and patient.||Patient Centeredness Score|Audio Recordings|Standard Deviation|Mean
637422|NCT02489799|Primary|Measured ACP Content in the Presurgical Consent Visit|The RIAS scoring system using an audio-recording of a conversation to evaluate conversation content.|Approximately one week after study enrollment.|Of note, the sample size is smaller for this outcome as our study did not collect recordings for all participants enrolled at the baseline visit. The reasons we did not collect the recordings include scheduling of emergent surgery without time to record, human and technology error, and patient preference.||Recordings|Recordings||Count of Units
637423|NCT02488980|Other Pre-specified|Safety (SAEs and AEs)|The most commonly reported experiences in subject occurring in at least 20% of subjects in any treatment group.|28 weeks|||participants|||Number
637424|NCT02488980|Secondary|Time to a Single Positive Smear|Kaplan-Meier survival curves were produced for time to parasitaemia for both first positive smear and two consecutive positive smears. 95.5% confidence intervals were constructed for the relative risk.|24 Weeks|||Days||95% Confidence Interval|Median
637425|NCT02488980|Secondary|Protective Efficacy Based on Two Consecutive Positive Smears|Kaplan-Meier survival curves were produced for time to parasitaemia for both first positive smear and two consecutive positive smears. Analysis was based on a calculation of protective efficacy (PE) of tefaenoquine, defined as (1-relative risk of developing parasitaemia tafenoquine: placebo) x100% and 95.5% confidence intervals were constructed for the relative risk using Koopman's method.|24 Weeks|||Percentage of Protective Efficacy||95% Confidence Interval|Number
637426|NCT02488980|Primary|Prophylactic Outcome Defined by the Subject Having no Positive Smears|Prophylactic outcome (success/failure) at the end of the prophylactic treatment phase; outcome was based on absence/presence of asexual stage parasites of any Plasmodium species on a single blood smear.|24 Weeks|||participants|||Number
637427|NCT02488317|Primary|Preparation for Decision Making|Measured using Bennett, Carol, “Validation of a Preparation for Decision Making Scale.” Patient Education and Counseling 78, no. 1: 130–33 10 item scale, each item scored from 1 (not at all) to 5 (a great deal). items are summed and scored, converted to a 0-100 scale by subtracting 1 from the summed score and multiplying by 25. Higher scores indicate higher perceived level of preparation for decision making.|6 months|This was a comparison of the intervention group before and after using the decision aid to assess its impact on preparing the participant for decision making. The question was therefore not administered to the control group since a similar pre/post comparison could not be tested in this group that was not exposed to the intervention.||units on a scale||Standard Deviation|Mean
637428|NCT02488317|Primary|Knowledge|Measured using scale from Cavanaugh K“Patient Dialysis Knowledge Is Associated with Permanent Arteriovenous Access Use in Chronic Hemodialysis.” Clinical Journal of the American Society of Nephrology 4, no. 5: 950–56) Multiple choice questions with one correct answer per questions. Number of correct questions reported as a percentage of total number of questions (23).|6 months|All participants who completed the questionnaire were included in these analyses.||scores on a scale||Standard Deviation|Mean
637429|NCT02488317|Primary|Decision Self-efficacy|"Measured through the scale found in Decision Self-Efficacy Ottawa: Ottawa Hospital Research Institute; © 1995 Available from: http://decisionaid.ohri.ca/docs/develop/User_Manuals/UM_Decision_SelfEfficacy.pdf O’Connor 1995 Items are scored 0(not at all confident) to 4 (very confident). Scores are summed across 10 items, divided by 10 and multiplied by 25. Scores range from 0-100. A score of 0 means extremely low self efficacy and a score of 100 means extremely high self efficacy."|6 months|All participants who completed the questionnaire were included in these analyses.||scores on a scale||Standard Deviation|Mean
637430|NCT02488317|Primary|Decisional Conflict|Measured using the scale from O’Connor, Annette M. “Validation of a Decisional Conflict Scale.” Medical Decision Making 15, no. 1 (February 1, 1995): 25–30. 16 item scale, responses to each statement are scored from 1 (strongly agree) to 5 (strongly disagree), with negative statements having reverse scoring; thus high scores indicate higher decisional conflict. Mean score per participant is calculated across all items, subtract by 1 and multiplied by 25. Score range= 0-100. Mean scores across all participants in each arm are reported.|6 months|All participants who completed the questionnaire were included in these analyses.||scores on a scale||Standard Deviation|Mean
637431|NCT02488317|Primary|Preference for Shared Decision Making|Measured using the scale from Degner, L. F., Sloan, J. A., & Venkatesh, P. (1996). The Control Preferences Scale. The Canadian journal of nursing research= Revue canadienne de recherche en sciences infirmieres, 29(3), 21-43. The CPS is a clinically relevant, easily administered, valid, and reliable measure of preferred roles in health-care decision-making. A pick-one approach was used to identify patient preference for an active, passive or collaborative role in dialysis treatment decision making.|6 months|||participants|||Number
637432|NCT02488070|Secondary|Feasibility of Ga-68 PSMA PET/CT or PET/MRI Scan|Feasibility of Ga68 PSMA PET/CT or PET/MRI is expressed as the number of subjects for whom the scan was successfully completed.|an estimated average of 2 hours|The population analyzed included all participants receiving Ga-68 PSMA PET/CT or PET/MRI scan.||participants|||Number
637433|NCT02488070|Primary|Focal Uptake (SUVmean)/ Background (F/N) Ratio of Ga68 PSMA|Focal uptake will be measured by drawing regions-of-interest (ROI) around areas with visually appreciable increased focal uptake over background (mediastinal blood pool) and calculating a SUVmean which is a semi-quantitative measurement of the average value of radiopharmaceutical uptake within the ROI. F/N ratio will be calculated by dividing the SUVmean by the background (mediastinal blood pool).|an estimated average of 1 hour|45 areas of high Ga68 PSMA focal uptake outside the normal biodistribution were used to calculate the average SUVmean. The mediastinal blood pool was used to determine average background.||F/N Ratio||Standard Deviation|Mean
637434|NCT02488070|Primary|Focal Uptake (SUVmax)/ Background (F/N) Ratio of Ga68 PSMA|Focal uptake will be measured by drawing regions-of-interest (ROI) around areas with visually appreciable increased focal uptake over background (mediastinal blood pool) and calculating a SUVmax which is a semi-quantitative measurement of the maximum value of radiopharmaceutical uptake within the ROI. F/N ratio will be calculated by dividing the SUVmax by the background (mediastinal blood pool).|an estimated average of 1 hour|45 areas of high Ga68 PSMA focal uptake outside the normal biodistribution were used to calculate the average SUVmax. The mediastinal blood pool was used to determine average background.||F/N Ratio||Standard Deviation|Mean
637435|NCT02488070|Primary|SUVmean of Ga68 PSMA Uptake Outside the Expected Normal Biodistribution|The biodistribution (ie, the location(s) of physiologic radiopharmaceutical uptake within the body) of Ga68 PSMA will be evaluated using PET/CT or PET/MRI. Biodistribution will be measured by drawing regions of interest (ROI) around areas with visually appreciable increased focal uptake over background (mediastinal blood pool) and calculating a SUVmean which is a semi-quantitative measurement of the average value of radiopharmaceutical uptake within the ROI.|an estimated average of 1 hour|45 areas of high Ga68 PSMA focal uptake outside the normal biodistribution were analyzed.||SUVmean|high focal uptake|Standard Deviation|Mean
637436|NCT02488070|Primary|SUVmax of Ga68 PSMA Uptake Outside the Expected Normal Biodistribution|The biodistribution (ie, the location(s) of physiologic radiopharmaceutical uptake within the body) of Ga68 PSMA will be evaluated using PET/CT or PET/MRI. Biodistribution will be measured by drawing regions of interest (ROI) around areas with visually appreciable increased focal uptake over background (mediastinal blood pool) and calculating a standardized uptake value maximum (SUVmax), which is a semi-quantitative measurement of the maximum value of radiopharmaceutical uptake within the ROI.|an estimated average of 1 hour|45 areas of focal increased Ga68 PSMA uptake were analyzed.||SUVmax|focal uptake|Standard Deviation|Mean
637437|NCT02488018|Primary|Examine Effect of Monofloral Honey Types on Glycemic Index of Health Human Subjects|Ten healthy individuals consumed monofloral honeys (25g of available carbohydrate in 250 mL water) after fasting for 11 hours. Blood glucose levels (mmol/L) were recorded at 0, 15, 30, 45, 60, 90 and 120 minutes. Time (0, 15, 30, 45, 60, 90 and 120 minutes) verse blood glucose levels (mmol/L) used to establish the area under the curve (AUC) for the honeys and reference glucose. This was used to calculate the glycemic index of honey each honey (GI= AUC for honey/AUC for reference glucose*100). All 10 participants took eight different honeys and reference glucose on nine different days (with randomized allocation of samples).|36 days (9 tests in 4 days interval)|All 10 participants took, 25g available carbohydrate of eight different honeys and reference glucose, on nine different days in 4 days interval. Blood was taken from finger prick using automatic lancet at 0, 15, 30, 45, 60, 90 and 120 minutes; glucose levels were recorded and area under the blood glucose curve was calculated.||Index||Standard Deviation|Mean
638357|NCT02439138|Secondary|Rate of Very Good Partial Response (VGPR)|VGPR measured by decrease in serum IgM levels of at least 90% from baseline.|Participants were followed for the duration of therapy, a median of one cycle, for up to 3 cycles.|||percentage of participants with VGPR|||Number
637450|NCT02486952|Secondary|Percentage of Participants Who Were Alive|Percentage of participants with survival was calculated 41 months after the first dose of study treatment.|Up to 41 months|Full analysis population.||percentage of participants|||Number
637451|NCT02486952|Primary|Probability of Event Free Survival (EFS)|EFS was calculated as the time from randomization to the date of first reported event. Events were defined as disease progression or relapse, institution of a new anticancer treatment, or death from any cause without progression.|Up to 41 months|Full analysis population.||probability of EFS||95% Confidence Interval|Number
637492|NCT02484729|Secondary|Renal Clearance of Drug From Plasma [CLR (0-48)]|To assess urine pharmacokinetic parameters following single ascending doses of AZD9977|Pre-dose and post-dose upto 48 hrs|The PK analysis set for Part A consisted of all subjects in the safety analysis set who received one dose of AZD9977 and had evaluable PK data. The PK analysis set for Part B consisted of all subjects in the safety analysis set who received at least one dose of AZD9977 and had evaluable PK data in at least one period.||L/h||Standard Deviation|Mean
637452|NCT02485483|Primary|Percentage of Participants With Prevalence of Depressive Symptomatology Based on a BDI-II Score Greater Than or Equal to (≥)14 or PHQ-9 Score ≥5: VADERA II|PHQ-9 is a self-reported questionnaire measuring depressive symptoms. This is a 9-item measure with a response score for each item on a 4-point scale ranging from 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 27; with 0-4 indicating no depressive symptoms, 5-9 mild, 10-14 moderate, 15-19 moderately severe, and 20-27 severe depression. BDI-II Scale is a 21-item self-reported questionnaire measuring existence and severity of depression symptoms. Symptoms are each scored on a 4-point scale of 0 (no symptom) to 3 (severe symptom). Total score ranges from 0-63; of which 0-8 is considered no depression, 0-13 minimal, 14-19 mild, 20-28 moderate, and 29-63 severe depression. Participants with a BDI-II score ≥14 or a PHQ-9 score ≥5 were classified as having depressive symptomatology. Participants were evaluated by positive depressive symptomatology for each questionnaire as well as being positive for both questionnaires combined or at least one of the questionnaires.|Baseline|Full analysis set of VADERA II population.||percentage of participants||95% Confidence Interval|Number
637453|NCT02485483|Primary|BDI-II Summary Score: VADERA II|BDI-II Scale is a 21-item self-reported questionnaire which measures the existence and severity of symptoms of depression. Each of the 21 items on BDI-II tool represent a depressive symptom. The symptoms are each scored on a 4-point Likert scale of 0 to 3 (0=symptom is absent; 3=symptom is severe). Scores for each symptom are added up to obtain the total scores for all 21 items. Total score ranges from 0-63; of which 0-8 is considered no depression, 0-13 is minimal depression, 14-19 is mild depression, 20-28 is moderate depression and 29-63 is severe depression.|Baseline|Full analysis set of VADERA II population. Number of participants analyzed = participants with BDI-II summary score assessment at baseline.||scores on a scale||Standard Deviation|Mean
637454|NCT02485483|Primary|PHQ-9 Summary Score: VADERA II|The PHQ-9 is a self-reported questionnaire measuring depressive symptoms. This is a nine item measure with a response score for each item on a 4-point scale ranging from 0 (not at all) to 3 (nearly every day). Thus, the total score ranges from 0 to 27; with 0-4 being minimum indicating no depressive symptoms, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, 20-27 severe depression.|Baseline|Full analysis set of VADERA II population defined as all study participants diagnosed with RA, who had given informed consent, and had completed at least one of the depression questionnaires. Number of participants analyzed = participants with PHQ-9 summary score assessment at baseline.||scores on a scale||Standard Deviation|Mean
637455|NCT02485483|Primary|MADRS at Week 12 ± 2: VADERA I|The MADRS, an interview addressing 10 characteristics of depressive symptomatology, was used as the gold standard. The symptom-related information provided by each participant was rated on item-specific scales ranging from 0 (best) to 6 (worst) in order to evaluate individual symptom severity. Total score was sum of 10 characteristics, ranging between 0 to 60; 0, no depression; 60, severely depressed. Sum scores exceeding 12 indicated clinical relevance suggested mild to severe symptomatology.|Week 12 ± 2|Validation analysis set of VADERA I population. Number of participants analyzed = participants with MADRS assessment at specified time-point.||scores on a scale||Standard Deviation|Mean
637456|NCT02485483|Primary|MADRS at Baseline: VADERA I|The MADRS, an interview addressing 10 characteristics of depressive symptomatology, was used as the gold standard. The symptom-related information provided by each participant was rated on item-specific scales ranging from 0 (best) to 6 (worst) in order to evaluate individual symptom severity. Total score was sum of 10 characteristics, ranging from 0 to 60; 0, no depression; 60, severely depressed. Sum scores exceeding 12 indicated clinical relevance suggested mild to severe symptomatology.|Baseline|Validation analysis set of VADERA I population. Number of participants analyzed = participants with MADRS assessment at baseline.||scores on a scale||Standard Deviation|Mean
637457|NCT02485483|Primary|WHO-5 Index at Week 12 ± 2: VADERA I|"WHO-5 questionnaire contains five items related to cheerfulness, calmness, feelings of vigor, feelings of being well rested after sleep, and personal interest. The respondent rated each question on a 6-point scale ranging from 0 (at no time) to 5 (all of the time) according to the proportion of time over the preceding 2 weeks that applied to the attribute in question. Scores were summated, with raw score ranging from 0 to 25. Then the scores were transformed to 0-100 by multiplying by 4, whereas 0 indicated the worst possible emotional well-being and 100 the best."|Week 12 ± 2|Validation analysis set of VADERA I population. Number of participants analyzed = participants with WHO-5 score assessment at specified time-point.||scores on a scale||Standard Deviation|Mean
637458|NCT02485483|Primary|WHO-5 Index at Baseline: VADERA I|"WHO-5 questionnaire contains five items related to cheerfulness, calmness, feelings of vigor, feelings of being well rested after sleep, and personal interest. The respondent rated each question on a 6-point scale ranging from 0 (at no time) to 5 (all of the time) according to the proportion of time over the preceding 2 weeks that applied to the attribute in question. Scores were summated, with raw score ranging from 0 to 25. Then the scores were transformed to 0-100 by multiplying by 4, whereas 0 indicated the worst possible emotional well-being and 100 the best."|Baseline|Validation analysis set of VADERA I population. Number of participants analyzed = participants with WHO-5 score assessment at baseline.||scores on a scale||Standard Deviation|Mean
637459|NCT02485483|Primary|BDI-II Score at Week 12 ± 2: VADERA I|BDI-II Scale is a 21-item self-reported questionnaire which measures the existence and severity of symptoms of depression. Each of the 21 items on BDI-II tool represent a depressive symptom. The symptoms are each scored on a 4-point Likert scale of 0 to 3 (0=symptom is absent; 3=symptom is severe). Scores for each symptom are added up to obtain the total scores for all 21 items. Total score ranges from 0-63; of which 0-8 is considered no depression, 0-13 is minimal depression, 14-19 is mild depression, 20-28 is moderate depression and 29-63 is severe depression.|Week 12 ± 2|Validation analysis set of VADERA I population. Number of participants analyzed = participants with BDI-II score assessment at specified time-point.||scores on a scale||Standard Deviation|Mean
637460|NCT02485483|Primary|BDI-II Score at Baseline: VADERA I|BDI-II Scale is a 21-item self-reported questionnaire which measures the existence and severity of symptoms of depression. Each of the 21 items on BDI-II tool represents a depressive symptom. The symptoms are each scored on a 4-point Likert scale of 0 to 3 (0=symptom is absent; 3=symptom is severe). Scores for each symptom are added up to obtain the total scores for all 21 items. Total score ranges from 0-63; of which 0-8 is considered no depression, 0-13 is minimal depression, 14-19 is mild depression, 20-28 is moderate depression and 29-63 is severe depression.|Baseline|Validation analysis set of VADERA I population. Number of participants analyzed = participants with BDI-II score assessment at baseline.||scores on a scale||Standard Deviation|Mean
637461|NCT02485483|Primary|PHQ-9 Score at Week 12 ± 2: VADERA I|The PHQ-9 is a self-reported questionnaire measuring depressive symptoms. This is a nine item measure with a response score for each item on a 4-point scale ranging from 0 (not at all) to 3 (nearly every day). Thus, the total score ranges from 0 to 27; with 0-4 being minimum indicating no depressive symptoms, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, 20-27 severe depression.|Week 12 ± 2|Validation analysis set of VADERA I population. Number of participants analyzed = participants with PHQ-9 score assessment at specified time-point.||scores on a scale||Standard Deviation|Mean
637462|NCT02485483|Primary|PHQ-9 Score at Baseline: VADERA I|The PHQ-9 is a self-reported questionnaire measuring depressive symptoms.This is a nine item measure with a response score for each item on a 4-point scale ranging from 0 (not at all) to 3 (nearly every day). Thus, the total score ranges from 0 to 27; with 0-4 being minimum indicating no depressive symptoms, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, 20-27 severe depression.|Baseline|Validation analysis set of VADERA I population defined as all study participants diagnosed with RA, who had given informed consent, and had no documented depression at baseline. Number of participants analyzed = participants with PHQ-9 score assessment at baseline.||scores on a scale||Standard Deviation|Mean
637463|NCT02485353|Secondary|Procedure or Procedure Related Adverse Events|Number of unique patients who had a procedure or treatment related (possible, probable or definite) adverse events. (graded per NCI CTC v4.0)|Up to 1 year|All patients enrolled and received treatment||Participants|||Count of Participants
637464|NCT02485353|Primary|Rate of Complete Remission|Percentage of patients who have complete remission as defined by the International Working Group for AML: morphologic complete remission (CR) or morphologic complete remission with incomplete blood count recovery (CRi or CRp)|2 months|All patients receiving at least one dose of study drug and having at least one evaluable post-baseline visit||percentage of patients|||Number
637465|NCT02485158|Primary|Change in Specific Drug Effects (Addiction Research Center Inventory) at 210 Minutes After Drink Administration|Specific drug effects will be measured using the Addiction Research Center Inventory (Martin et al. 1971). The ARCI measures effects specific to drug classes, including the effects of AMP-like drugs (A scale, 0 to 11), morphine and benzedrine like drugs (MBG scale, 0 to 14), lysergic acid-like drugs (LSD scale, 0 to 14), benzedrine-like drugs (BG scale, 0 to 13), pentobarbital-chlorpromazine and ALC-like drugs (PCAG scale, 0 to 15), and cannabis-like drugs (M scale, 0 to 12). We used this questionnaire as a manipulation check to ensure that the drugs produced their typical drug-specific effects in this study. For example, zero value of A sacle would be minimum report of amphetamine-like drug effects, and 11 would be maximum report of amphetamine-like effects.The change in ARCI was assessed by the difference in measurements between baseline and 210 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.|Measured 15 minutes prior to capsule administration and 210 minutes after drink administration|Participants who completed all sessions||units on a scale||Standard Deviation|Mean
637466|NCT02485158|Primary|Change in Specific Drug Effects (Addiction Research Center Inventory) at 180 Minutes After Drink Administration|Specific drug effects will be measured using the Addiction Research Center Inventory (Martin et al. 1971). The ARCI measures effects specific to drug classes, including the effects of AMP-like drugs (A scale, 0 to 11), morphine and benzedrine like drugs (MBG scale, 0 to 14), lysergic acid-like drugs (LSD scale, 0 to 14), benzedrine-like drugs (BG scale, 0 to 13), pentobarbital-chlorpromazine and ALC-like drugs (PCAG scale, 0 to 15), and cannabis-like drugs (M scale, 0 to 12). We used this questionnaire as a manipulation check to ensure that the drugs produced their typical drug-specific effects in this study. For example, zero value of A sacle would be minimum report of amphetamine-like drug effects, and 11 would be maximum report of amphetamine-like effects.The change in ARCI was assessed by the difference in measurements between baseline and 180 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.|Measured 15 minutes prior to capsule administration and 180 minutes after drink administration|Participants who completed all sessions||units on a scale||Standard Deviation|Mean
637467|NCT02485158|Primary|Change in Specific Drug Effects (Addiction Research Center Inventory) at 150 Minutes After Drink Administration|Specific drug effects will be measured using the Addiction Research Center Inventory (Martin et al. 1971). The ARCI measures effects specific to drug classes, including the effects of AMP-like drugs (A scale, 0 to 11), morphine and benzedrine like drugs (MBG scale, 0 to 14), lysergic acid-like drugs (LSD scale, 0 to 14), benzedrine-like drugs (BG scale, 0 to 13), pentobarbital-chlorpromazine and ALC-like drugs (PCAG scale, 0 to 15), and cannabis-like drugs (M scale, 0 to 12). We used this questionnaire as a manipulation check to ensure that the drugs produced their typical drug-specific effects in this study. For example, zero value of A sacle would be minimum report of amphetamine-like drug effects, and 11 would be maximum report of amphetamine-like effects.The change in ARCI was assessed by the difference in measurements between baseline and 150 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.|Measured 15 minutes prior to capsule administration and 150 minutes after drink administration|Participants who completed all sessions||units on a scale||Standard Deviation|Mean
637468|NCT02485158|Primary|Change in Specific Drug Effects (Addiction Research Center Inventory) at 120 Minutes After Drink Administration|Specific drug effects will be measured using the Addiction Research Center Inventory (Martin et al. 1971). The ARCI measures effects specific to drug classes, including the effects of AMP-like drugs (A scale, 0 to 11), morphine and benzedrine like drugs (MBG scale, 0 to 14), lysergic acid-like drugs (LSD scale, 0 to 14), benzedrine-like drugs (BG scale, 0 to 13), pentobarbital-chlorpromazine and ALC-like drugs (PCAG scale, 0 to 15), and cannabis-like drugs (M scale, 0 to 12). We used this questionnaire as a manipulation check to ensure that the drugs produced their typical drug-specific effects in this study. For example, zero value of A sacle would be minimum report of amphetamine-like drug effects, and 11 would be maximum report of amphetamine-like effects.The change in ARCI was assessed by the difference in measurements between baseline and 120 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.|Measured 15 minutes prior to capsule administration and 120 minutes after drink administration|Participants who completed all sessions||units on a scale||Standard Deviation|Mean
637507|NCT02484729|Primary|Safety and Tolerability of AZD9977 by Number of Participants With Clinically Significant Trends in Cardiac Telemetry|To assess the safety and tolerability of single ascending doses of AZD9977|For up to 4 days, i.e. on the day before each dosing and for 24 hours after each dosing|All subjects who received at least one dose of IMP and for whom any safety post-dose data were available were included in the safety analysis for the study.||Number of Participants|||Number
637469|NCT02485158|Primary|Change in Specific Drug Effects (Addiction Research Center Inventory) at 90 Minutes After Drink Administration|Specific drug effects will be measured using the Addiction Research Center Inventory (Martin et al. 1971). The ARCI measures effects specific to drug classes, including the effects of AMP-like drugs (A scale, 0 to 11), morphine and benzedrine like drugs (MBG scale, 0 to 14), lysergic acid-like drugs (LSD scale, 0 to 14), benzedrine-like drugs (BG scale, 0 to 13), pentobarbital-chlorpromazine and ALC-like drugs (PCAG scale, 0 to 15), and cannabis-like drugs (M scale, 0 to 12). We used this questionnaire as a manipulation check to ensure that the drugs produced their typical drug-specific effects in this study. For example, zero value of A sacle would be minimum report of amphetamine-like drug effects, and 11 would be maximum report of amphetamine-like effects. The change in ARCI was assessed by the difference in measurements between baseline and 90 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.|Measured 15 minutes prior to capsule administration and 90 minutes after drink administration|Participants who completed all sessions||units on a scale||Standard Deviation|Mean
637470|NCT02485158|Primary|Change in Specific Drug Effects (Addiction Research Center Inventory) at 30 Minutes After Drink Administration|Specific drug effects will be measured using the Addiction Research Center Inventory (Martin et al. 1971). The ARCI measures effects specific to drug classes, including the effects of AMP-like drugs (A scale, 0 to 11), morphine and benzedrine like drugs (MBG scale, 0 to 14), lysergic acid-like drugs (LSD scale, 0 to 14), benzedrine-like drugs (BG scale, 0 to 13), pentobarbital-chlorpromazine and ALC-like drugs (PCAG scale, 0 to 15), and cannabis-like drugs (M scale, 0 to 12). We used this questionnaire as a manipulation check to ensure that the drugs produced their typical drug-specific effects in this study. For example, zero value of A sacle would be minimum report of amphetamine-like drug effects, and 11 would be maximum report of amphetamine-like effects. The change in ARCI was assessed by the difference in measurements between baseline and 30 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.|Measured 15 minutes prior to capsule administration and 30 minutes after drink administration|Participants who completed all sessions||units on a scale||Standard Deviation|Mean
637471|NCT02485158|Primary|Change in Specific Drug Effects (Addiction Research Center Inventory) at 30 Minutes After Capsule Administration|Specific drug effects will be measured using the Addiction Research Center Inventory (Martin et al. 1971). The ARCI measures effects specific to drug classes, including the effects of AMP-like drugs (A scale, 0 to 11), morphine and benzedrine like drugs (MBG scale, 0 to 14), lysergic acid-like drugs (LSD scale, 0 to 14), benzedrine-like drugs (BG scale, 0 to 13), pentobarbital-chlorpromazine and ALC-like drugs (PCAG scale, 0 to 15), and cannabis-like drugs (M scale, 0 to 12). We used this questionnaire as a manipulation check to ensure that the drugs produced their typical drug-specific effects in this study. For example, zero value of A sacle would be minimum report of amphetamine-like drug effects, and 11 would be maximum report of amphetamine-like effects. The change in ARCI was assessed by the difference in measurements between baseline and 30 minutes after capsule administration and before drink administration. Baseline was measure 15 minutes prior to capsule administration.|Measured 15 minutes prior to capsule administration and 30 minutes after capsule administration and before drink administration|Participants who completed all sessions||units on a scale||Standard Deviation|Mean
637472|NCT02485158|Primary|Change in General Drug Effects (Drug Effects Questionnaire) at 210 Minutes After Drink Administration|Drug effects will be measured using the Drug Effects Questionnaire (Fischman & Foltin, 1991). The DEQ included 5 subscales; feeling, liking, and disliking the drug effect, feeling high, and wanting more of the drug. Each subscale ranged from 1(Not at all) to 100(Very much). The change in DFQ was assessed by the difference in measurements between baseline and 210 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.|Measured 15 minutes prior to capsule administration and 210 minutes after drink administration.|Participants who completed all sessions||units on a scale||Standard Deviation|Mean
637473|NCT02485158|Primary|Change in General Drug Effects (Drug Effects Questionnaire) at 180 Minutes After Drink Administration|Drug effects will be measured using the Drug Effects Questionnaire (Fischman & Foltin, 1991). The DEQ included 5 subscales; feeling, liking, and disliking the drug effect, feeling high, and wanting more of the drug. Each subscale ranged from 1(Not at all) to 100(Very much). The change in DFQ was assessed by the difference in measurements between baseline and 180 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.|Measured 15 minutes prior to capsule administration and 180 minutes after drink administration.|Participants who completed all sessions||units on a scale||Standard Deviation|Mean
637474|NCT02485158|Primary|Change in General Drug Effects (Drug Effects Questionnaire) at 150 Minutes After Drink Administration|Drug effects will be measured using the Drug Effects Questionnaire (Fischman & Foltin, 1991). The DEQ included 5 subscales; feeling, liking, and disliking the drug effect, feeling high, and wanting more of the drug. Each subscale ranged from 1(Not at all) to 100(Very much). The change in DFQ was assessed by the difference in measurements between baseline and 150 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.|Measured 15 minutes prior to capsule administration and 150 minutes after drink administration.|Participants who completed all sessions||units on a scale||Standard Deviation|Mean
637475|NCT02485158|Primary|Change in General Drug Effects (Drug Effects Questionnaire) at 120 Minutes After Drink Administraion|Drug effects will be measured using the Drug Effects Questionnaire (Fischman & Foltin, 1991). The DEQ included 5 subscales; feeling, liking, and disliking the drug effect, feeling high, and wanting more of the drug. Each subscale ranged from 1(Not at all) to 100(Very much). The change in DFQ was assessed by the difference in measurements between baseline and 120 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.|Measured 15 minutes prior to capsule administration and 120 minutes after drink administration.|Participants who completed all sessions||units on a scale||Standard Deviation|Mean
637476|NCT02485158|Primary|Change in General Drug Effects (Drug Effects Questionnaire) at 90 Minutes After Drink Administration|Drug effects will be measured using the Drug Effects Questionnaire (Fischman & Foltin, 1991). The DEQ included 5 subscales; feeling, liking, and disliking the drug effect, feeling high, and wanting more of the drug. Each subscale ranged from 1(Not at all) to 100(Very much). The change in DFQ was assessed by the difference in measurements between baseline and 90 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.|Measured 15 minutes prior to capsule administration and 90 minutes after drink administration.|Participants who completed all sessions||units on a scale||Standard Deviation|Mean
637477|NCT02485158|Primary|Change in General Drug Effects (Drug Effects Questionnaire) at 30 Minutes After Drink Administration|Drug effects will be measured using the Drug Effects Questionnaire (Fischman & Foltin, 1991). The DEQ included 5 subscales; feeling, liking, and disliking the drug effect, feeling high, and wanting more of the drug. Each subscale ranged from 1(Not at all) to 100(Very much). The change in DFQ was assessed by the difference in measurements between baseline and 30 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.|Measured 15 minutes prior to capsule administration and 30 minutes after drink administration.|Participants who completed all sessions||units on a scale||Standard Deviation|Mean
637478|NCT02485158|Primary|Change in General Drug Effects (Drug Effects Questionnaire) at 30 Minutes After Capsule Administration|Drug effects will be measured using the Drug Effects Questionnaire (Fischman & Foltin, 1991). The DEQ included 5 subscales; feeling, liking, and disliking the drug effect, feeling high, and wanting more of the drug. Each subscale ranged from 1(Not at all) to 100(Very much). The change in DFQ was assessed by the difference in measurements between baseline and 30 minutes after capsule administration and before drink administration. Baseline was measure 15 minutes prior to capsule administration.|Measured 15 minutes prior to capsule administration and 30 minutes after capsule administration and before drink administration|Participants who completed all sessions||units on a scale||Standard Deviation|Mean
637479|NCT02484911|Secondary|Proportion of Participants Receiving MEC With No Vomiting in the Delayed Phase|"Overall Phase was defined as 24 to 120 hours following initiation of chemotherapy.
No vomiting was defined as no vomiting or retching or dry heaves (included participants who received rescue therapy)."|24 to 120 hours|FAS (full analysis set) patient population was used for all efficacy evaluations and included patients who (1) received Moderate Emetogenic Chemotherapy (MEC), (2) took a dose of study drug, and (3) completed treatment.||Participants|||Count of Participants
637480|NCT02484911|Secondary|Proportion of Participants Receiving MEC With No Vomiting in the Acute Phase|"Overall Phase was defined as 0 to 24 hours following initiation of chemotherapy.
No vomiting was defined as no vomiting or retching or dry heaves (included participants who received rescue therapy)."|0 to 24 hours|FAS (full analysis set) patient population was used for all efficacy evaluations and included patients who (1) received Moderate Emetogenic Chemotherapy (MEC), (2) took a dose of study drug, and (3) completed treatment.||Participants|||Count of Participants
637481|NCT02484911|Secondary|Proportion of Participants Receiving MEC With No Vomiting in the Overall Phase|"Overall Phase was defined as 0 to 120 hours following initiation of chemotherapy.
No vomiting was defined as no vomiting or retching or dry heaves (included participants who received rescue therapy)."|0-120 hours|FAS (full analysis set) patient population was used for all efficacy evaluations and included patients who (1) received Moderate Emetogenic Chemotherapy (MEC), (2) took a dose of study drug, and (3) completed treatment.||Participants|||Count of Participants
637482|NCT02484911|Secondary|Proportion of Participants Receiving MEC With Complete Response in the Delayed Phase|"Delayed phase was defined as 24 to 120 hours following initiation of chemotherapy.
Complete response was defined as no vomiting with no rescue therapy."|24 to 120 hours|FAS (full analysis set) patient population was used for all efficacy evaluations and included patients who (1) received Moderate Emetogenic Chemotherapy (MEC), (2) took a dose of study drug, and (3) completed treatment.||Participants|||Count of Participants
637483|NCT02484911|Secondary|Proportion of Participants Receiving MEC With Complete Response in the Acute Phase|Acute phase was defined as 0 to 24 hours following initiation of chemotherapy. Complete response was defined as no vomiting with no rescue therapy.|0 to 24 hours|FAS (full analysis set) patient population was used for all efficacy evaluations and included patients who (1) received Moderate Emetogenic Chemotherapy (MEC), (2) took a dose of study drug, and (3) completed treatment.||Participants|||Count of Participants
637484|NCT02484911|Secondary|Proportion of Participants Receiving HEC With No Vomiting in the Delayed Phase|"Overall Phase was defined as 24 to 120 hours following initiation of chemotherapy.
No vomiting was defined as no vomiting or retching or dry heaves (included participants who received rescue therapy)."|24 to 120 hours|FAS (full analysis set) patient population was used for all efficacy evaluations and included patients who (1) received High Emetogenic Chemotherapy (HEC), (2) took a dose of study drug, and (3) completed treatment.||Participants|||Count of Participants
637485|NCT02484911|Secondary|Proportion of Participants Receiving HEC With No Vomiting in the Acute Phase|"Overall Phase was defined as 0 to 120 hours following initiation of chemotherapy.
No vomiting was defined as no vomiting or retching or dry heaves (included participants who received rescue ）"|0 to 24 hours|FAS (full analysis set) patient population was used for all efficacy evaluations and included patients who (1) received High Emetogenic Chemotherapy (HEC), (2) took a dose of study drug, and (3) completed treatment.||Participants|||Count of Participants
637486|NCT02484911|Secondary|Proportion of Participants Receiving HEC With No Vomiting in the Overall Phase|"Overall phase was defined as 0 to 120 hours following initiation of chemotherapy.
No vomiting was defined as no vomiting or retching or dry heaves (included participants who received rescue therapy)."|0 to 120 hours|FAS (full analysis set) patient population was used for all efficacy evaluations and included patients who (1) received High Emetogenic Chemotherapy (HEC), (2) took a dose of study drug, and (3) completed treatment.||Participants|||Count of Participants
637487|NCT02484911|Secondary|Proportion of Participants Receiving HEC With Complete Response in the Delayed Phase|"Delayed phase was defined as 24 to 120 hours following initiation of chemotherapy.
Complete response was defined as no vomiting with no rescue therapy."|24 to 120 hours|FAS (full analysis set) patient population was used for all efficacy evaluations and included patients who (1) received High Emetogenic Chemotherapy (HEC), (2) took a dose of study drug, and (3) completed treatment.||Participants|||Count of Participants
637488|NCT02484911|Secondary|Proportion of Participants Receiving HEC With Complete Response in the Acute Phase|Acute phase was defined as 0 to 24 hours following initiation of chemotherapy. Complete response was defined as no vomiting with no rescue therapy.|0 to 24 hours|FAS (full analysis set) patient population was used for all efficacy evaluations and included patients who (1) received High Emetogenic Chemotherapy (HEC), (2) took a dose of study drug, and (3) completed treatment.||Participants|||Count of Participants
637575|NCT02480712|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.|Posttreatment Week 12|Full Analysis Set: All enrolled participants who received at least one dose of study drug.||percentage of participants||95% Confidence Interval|Number
637493|NCT02484729|Secondary|Fraction Excreted Unchanged in Urine[Fe (0-48)]|To assess percentage of the total drug excreted in the urine that was unchanged following single ascending doses of AZD9977|Pre-dose and post-dose upto 48 hrs|The PK analysis set for Part A consisted of all subjects in the safety analysis set who received one dose of AZD9977 and had evaluable PK data. The PK analysis set for Part B consisted of all subjects in the safety analysis set who received at least one dose of AZD9977 and had evaluable PK data in at least one period.||Percentage||Standard Deviation|Mean
637494|NCT02484729|Secondary|Cumulative Amount of Unchanged Drug Excreted Into Urine [Ae (0-48)]|To assess urine pharmacokinetic parameters following single ascending doses of AZD9977|Pre-dose and post-dose upto 48 hrs|The PK analysis set for Part A consisted of all subjects in the safety analysis set who received one dose of AZD9977 and had evaluable PK data. The PK analysis set for Part B consisted of all subjects in the safety analysis set who received at least one dose of AZD9977 and had evaluable PK data in at least one period.||nmol||Standard Deviation|Mean
637495|NCT02484729|Secondary|Apparent Volume of Distribution (Vz/F)|To assess plasma pharmacokinetic parameters following single ascending doses of AZD977|Pre-dose and post-dose upto 48 hrs|The PK analysis set for Part A consisted of all subjects in the safety analysis set who received one dose of AZD9977 and had evaluable PK data. The PK analysis set for Part B consisted of all subjects in the safety analysis set who received at least one dose of AZD9977 and had evaluable PK data in at least one period.||L||Standard Deviation|Mean
637496|NCT02484729|Secondary|Apparent Clearance (CL/F)|To assess plasma pharmacokinetic parameters following single ascending doses of AZD977|Pre-dose and post-dose upto 48 hrs|The PK analysis set for Part A consisted of all subjects in the safety analysis set who received one dose of AZD9977 and had evaluable PK data. The PK analysis set for Part B consisted of all subjects in the safety analysis set who received at least one dose of AZD9977 and had evaluable PK data in at least one period.||L/h||Standard Deviation|Mean
637497|NCT02484729|Secondary|Half-life Associated With Terminal Slope (λz) of a Semi-logarithmic Concentration-time Curve (t1/2λz)|To assess plasma pharmacokinetic parameters following single ascending doses of AZD977|Pre-dose and post-dose upto 48 hrs|The PK analysis set for Part A consisted of all subjects in the safety analysis set who received one dose of AZD9977 and had evaluable PK data. The PK analysis set for Part B consisted of all subjects in the safety analysis set who received at least one dose of AZD9977 and had evaluable PK data in at least one period.||Hour (h)||Standard Deviation|Mean
637498|NCT02484729|Secondary|Time to Maximum Observed Plasma Concentration (t Max)|To assess plasma pharmacokinetic parameters following single ascending doses of AZD977|Pre-dose and post-dose upto 48 hrs|The PK analysis set for Part A consisted of all subjects in the safety analysis set who received one dose of AZD9977 and had evaluable PK data. The PK analysis set for Part B consisted of all subjects in the safety analysis set who received at least one dose of AZD9977 and had evaluable PK data in at least one period.||Hour (h)||Full Range|Median
637499|NCT02484729|Secondary|Observed Maximum Concentration (Cmax)|To assess plasma pharmacokinetic parameters following single ascending doses of AZD977|Pre-dose and post-dose upto 48 hrs|The PK analysis set for Part A consisted of all subjects in the safety analysis set who received one dose of AZD9977 and had evaluable PK data. The PK analysis set for Part B consisted of all subjects in the safety analysis set who received at least one dose of AZD9977 and had evaluable PK data in at least one period.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
637500|NCT02484729|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Analyte concentrationAUC(0-t)|To assess plasma pharmacokinetic parameters following single ascending doses of AZD977|Pre-dose and post-dose upto 48 hrs|The PK analysis set for Part A consisted of all subjects in the safety analysis set who received one dose of AZD9977 and had evaluable PK data. The PK analysis set for Part B consisted of all subjects in the safety analysis set who received at least one dose of AZD9977 and had evaluable PK data in at least one period.||h.nmol/L||Geometric Coefficient of Variation|Geometric Mean
637501|NCT02484729|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC) From Zero Extrapolated to Infinity.|To assess plasma pharmacokinetic parameters following single ascending doses of AZD977|Pre-dose and post-dose upto 48 hrs|The PK analysis set for Part A consisted of all subjects in the safety analysis set who received one dose of AZD9977 and had evaluable PK data. The PK analysis set for Part B consisted of all subjects in the safety analysis set who received at least one dose of AZD9977 and had evaluable PK data in at least one period.||h.nmol/L||Geometric Coefficient of Variation|Geometric Mean
637502|NCT02484729|Primary|Safety and Tolerability of AZD9977 by Assessing Number of Participants With Clinically Significant Changes in Urinalysis|To assess the safety and tolerability of single ascending doses of AZD9977|For up to 45 days, i.e. from Screening to Follow-up|All subjects who received at least one dose of IMP and for whom any safety post-dose data were available were included in the safety analysis for the study.||Number of participants|||Number
637503|NCT02484729|Primary|Safety and Tolerability of AZD9977 by Assessing Number of Participants With Clinically Significant Changes in Clinical Chemistry|To assess the safety and tolerability of single ascending doses of AZD9977|For up to 45 days, i.e. from Screening to Follow-up|All subjects who received at least one dose of IMP and for whom any safety post-dose data were available were included in the safety analysis for the study.||Number of participants|||Number
637504|NCT02484729|Primary|Safety and Tolerability of AZD9977 by Assessing Number of Participants With Clinically Significant Changes in Hematology|To assess the safety and tolerability of single ascending doses of AZD9977|For up to 45 days, i.e. from Screening to Follow-up|All subjects who received at least one dose of IMP and for whom any safety post-dose data were available were included in the safety analysis for the study.||Number of participants|||Number
637505|NCT02484729|Primary|Safety and Tolerability of AZD9977 by Assessing Number of Participants With Clinically Significant Changes in Blood Pressure|To assess the safety and tolerability of single ascending doses of AZD9977|For up to 45 days, i.e. from Screening to Follow-up|All subjects who received at least one dose of IMP and for whom any safety post-dose data were available were included in the safety analysis for the study.||Number of Participants|||Number
637506|NCT02484729|Primary|Safety and Tolerability of AZD9977 by Assessing the Number of Subjects With Adverse Events|To assess the safety and tolerability of single ascending doses of AZD9977|For up to 45 days, i.e. from Screening to Follow-up|All subjects who received at least one dose of IMP and for whom any safety post-dose data were available were included in the safety analysis for the study.||Number of Participants|||Number
637509|NCT02484729|Primary|Safety and Tolerability of AZD9977 by Assessing Number of Participants With Clinically Significant Pulse Rate|To assess the safety and tolerability of single ascending doses of AZD9977|For up to 45 days, i.e. from Screening to Follow-up|All subjects who received at least one dose of IMP and for whom any safety post-dose data were available were included in the safety analysis for the study.||Number of Participants|||Number
637510|NCT02484729|Primary|Safety and Tolerability of AZD9977 by Assessing the Percentage of Participants With Adverse Events|To assess the safety and tolerability of single ascending doses of AZD9977|For up to 45 days, i.e. from Screening to Follow-up|All subjects who received at least one dose of IMP and for whom any safety post-dose data were available were included in the safety analysis for the study.||percentage of participants|||Number
637511|NCT02483975|Secondary|Change From Baseline (Expressed as a Ratio) in 24-hour 6-beta Hydroxycortisol Excretion at the End of the Six Week Treatment Period (Day 42).|The 24 hr urinary 6-beta hydroxycortisol excretion was collected over a 24 hour period on Day 0 and Day 42. Change from baseline in 24- hr urinary 6-beta hydroxycortisol excretion was calculated as a ratio from baseline defined as 24-hr urinary 6-beta hydroxycortisol excretion at Week 6 divided by the baseline 24-hr urinary 6-beta hydroxycortisol excretion. The ratio from baseline was loge transformed prior to analysis. The loge transformed ratio was compared between treatment groups using an analysis of covariance (ANCOVA) model, allowing for the effects of baseline (loge transformed), age, sex and region. Treatment ratios for comparison was calculated by back-transforming the difference between the Least square (LS) means. Using the pooled estimate of variance, 95% Confidence Intervals (CIs) was calculated for the difference. Participants with 24-hr urinary cortisol excretion at baseline and Week 6 were analyzed.|Baseline (Day 0) Day 42|The UC Population.||Ratio||Geometric Coefficient of Variation|Geometric Mean
637512|NCT02483975|Secondary|Change From Baseline (Expressed as a Ratio) in 24-hour Urinary Cortisol Excretion at the End of the Six Week Treatment Period (Day 42)|The 24 hr urinary cortisol excretion was collected over a 24 hour period on Day 0 and Day 42. Change from baseline in 24- hr urinary cortisol excretion was calculated as a ratio from baseline defined as 24-hr urinary cortisol excretion at Week 6 divided by the baseline 24-hr urinary cortisol excretion. The ratio from baseline was loge transformed prior to analysis. The loge transformed ratio was compared between treatment groups using an analysis of covariance (ANCOVA) model, allowing for the effects of baseline (loge transformed), age, sex and region. Treatment ratios for comparison was calculated by back-transforming the difference between the Least square (LS) means. Using the pooled estimate of variance, 95% Confidence Intervals (CIs) was calculated for the difference. Participants with 24-hr urinary cortisol excretion at baseline and Week 6 were analyzed.|Baseline (Day 0) Day 42|The Urinary Cortisol (UC) Population used consisted of all participants who did not have protocol violations that were considered to affect the urine cortisol endpoint and whose urine samples were not considered to have confounding factors that affect the interpretation of the results.||Ratio||Geometric Coefficient of Variation|Geometric Mean
637513|NCT02483975|Secondary|Change From Baseline (Expressed as a Ratio) in Area Under the Curve (AUC) 0-24 Hour Serum Cortisol at the End of the Six Week Treatment Period (Day 42).|The blood samples for statistical analysis of area under the curve over the 24 hours (AUC 0-24 hours) endpoints were collected on Day 0 and Day 42 at the indicated time points. The AUC 0-24 hours was calculated using trapezoidal rule. Change from baseline in AUC 0-24 hour was calculated as a ratio from baseline defined as the AUC (0-24 hours) at Week 6 divided by the baseline AUC (0-24 hours) The ratio from baseline was loge transformed prior to analysis. The loge transformed ratios were compared between treatment groups as treatment ratios using an analysis of covariance (ANCOVA) model, allowing for the effects of baseline (loge transformed), age, sex and region. Treatment ratios for comparison was calculated by back-transforming the difference between the Least square (LS) means. Using the pooled estimate of variance, 95% Confidence Intervals (CIs) was calculated for the difference. Par. with SC weighted mean (0-24hr) calculated at baseline and Week 6 were analyzed|Baseline and Week Baseline, Day 0 (Predose, 2hr, 4hr, 8hr, 12hr, 16hr and 24hr) and Day 42 (0hr, 2hr, 4hr, 8hr, 16hr and 24hr)|The SC population||Ratio||Geometric Coefficient of Variation|Geometric Mean
637514|NCT02483975|Primary|Change From Baseline (Expressed as a Ratio) in 0-24 Hour Weighted Mean Serum Cortisol at the End of the Six Week Treatment Period (Day 42) in SC Population|The blood samples for statistical analysis of serum cortisol (SC) endpoints were collected on D0 and D42 at indicated time points. The weighted mean was calculated by dividing the area under curve (AUC) over the 24-hr time period by time period. Change from Baseline in 0-24 hr weighted mean SC was calculated as a ratio from baseline defined as SC weighted mean (0-24 hrs) at Wk 6 divided by the baseline SC weighted mean (0-24 hrs). The ratio as treatment ratios, using an analysis of covariance (ANCOVA) model, allowing for the effects of baseline (loge transformed from baseline was loge transformed prior to analysis. The loge transformed ratios were compared between treatment groups), age, sex and region. Treatment ratios for comparison was calculated by back-transforming the difference between Least square (LS) means. Using the pooled estimate of variance, 95% CIs) was calculated for the difference.|Baseline, Day 0 (Predose, 2hr, 4hr, 8hr, 12hr, 16hr and 24hr) and Day 42 (0hr, 2hr, 4hr, 8hr, 16hr and 24hr)|SC Population consisted of all par. in the ITT pop who did not have protocol violations that considered to affect the SC endpoint and whose serum samples were not considered to have confounding factors that would affect the interpretation of results. Par. with SC weighted mean (0-24 hr) calculated at baseline and Wk 6 were analyzed.||Ratio||Geometric Coefficient of Variation|Geometric Mean
637528|NCT02483611|Secondary|HR - M6 (Heart Rate in the Moment 6)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as one minute after the tracheal intubation. This time point was named as moment '6'.|This measure of heart rate was performed one minute after the tracheal intubation|||beats/min||Standard Deviation|Mean
637529|NCT02483611|Secondary|HR - M5 (Heart Rate in the Moment 5)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as immediately before the tracheal intubation. This time point was named as moment '5'.|This measure of heart rate was performed immediately before the tracheal intubation|||beats/min||Standard Deviation|Mean
637692|NCT02475980|Primary|Length of Stay|Emergency department length of stay for participants|Measured at time of chart review for patient follow-up, approximately 4 weeks after enrollment.|||minutes||Full Range|Median
640958|NCT02327429|Primary|Change in Energy Intake (3-day Food Record)|Intake assessed pre-post intervention using a 3-day food record|12 weeks|||kcal||Standard Deviation|Mean
637515|NCT02483975|Primary|Change From Baseline (Expressed as a Ratio) in 0-24 Hour Weighted Mean Serum Cortisol at the End of the Six Week Treatment Period (D 42) in Intention-to-treat (ITT) Population|The blood samples for statistical analysis of serum cortisol (SC) endpoints were collected on D 0 and D 42 at the indicated time points. The weighted mean was calculated by dividing the area under the curve (AUC) over the 24-hour (hr) time period by the time period. Change from Baseline in 0-24 hr weighted mean SC was calculated as a ratio from Baseline defined as the SC weighted mean (0-24 hours) at Week 6 divided by the Baseline SC weighted mean (0-24 hours).The ratio from Baseline was loge transformed prior to analysis. The loge transformed ratios were compared between treatment groups as treatment ratios, using an analysis of covariance (ANCOVA) model, allowing for the effects of Baseline (loge transformed), age, sex and region. Treatment ratios for comparison was calculated by back-transforming the difference between the Least square (LS) means. Using the pooled estimate of variance, 95% Confidence Intervals (CIs) was calculated for the difference.|Baseline, D 0 (Pre-dose, 2hr, 4hr, 8hr, 12hr, 16hr and 24hr) and Day 42 (0hr, 2hr, 4hr, 8hr, 16hr and 24hr)|ITT Population (pop) comprised of all randomized par. who received at least one dose of study medication. Randomized par. were assumed to have received study medication unless definitive evidence to the contrary exists. Par. with SC weighted mean (0-24 hr) calculated at Baseline and Week 6 were analyzed.||Ratio||Geometric Coefficient of Variation|Geometric Mean
637516|NCT02483611|Secondary|HR - M7f (Heart Rate in the Moment 7f)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as 90 minutes after the traqueal intubation. This time point was named as moment '7f'.|This measure of heart rate was performed 90 minutes after the traqueal intubation|||beats/min||Inter-Quartile Range|Median
637517|NCT02483611|Secondary|HR - M7e (Heart Rate in the Moment 7e)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as 75 minutes after the traqueal intubation. This time point was named as moment '7e'.|This measure of heart rate was performed 75 minutes after the traqueal intubation|||beats/min||Inter-Quartile Range|Median
637518|NCT02483611|Secondary|HR - M7d (Heart Rate in the Moment 7d)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as 60 minutes after the traqueal intubation. This time point was named as moment '7d'.|This measure of heart rate was performed 60 minutes after the traqueal intubation|||beats/min||Standard Deviation|Mean
637519|NCT02483611|Secondary|HR - M7c (Heart Rate in the Moment 7c)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as 45 minutes after the traqueal intubation. This time point was named as moment '7c'.|This measure of heart rate was performed 45 minutes after the traqueal intubation|||beats/min||Standard Deviation|Mean
637520|NCT02483611|Secondary|HR - M7b (Heart Rate in the Moment 7b)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as 30 minutes after the traqueal intubation. This time point was named as moment '7b'.|This measure of heart rate was performed 30 minutes after the traqueal intubation|||beats/min||Standard Deviation|Mean
637521|NCT02483611|Secondary|HR - M7a (Heart Rate in the Moment 7a)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as 15 minutes after the traqueal intubation.This time point was named as moment '7a'.|This measure of heart rate was performed 15 minutes after the traqueal intubation|||beats/min||Standard Deviation|Mean
637522|NCT02483611|Secondary|MAP - M7f (Mean Arterial Pressure in the Moment 7f)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as 90 minutes after the traqueal intubation. This time point was named as moment '7f'.|This measure of average blood pressure was performed 90 minutes after the traqueal intubation|||mmHg||Inter-Quartile Range|Median
637523|NCT02483611|Secondary|MAP - M7e (Mean Arterial Pressure in the Moment 7e)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as 75 minutes after the traqueal intubation. This time point was named as moment '7e'.|This measure of average blood pressure was performed 75 minutes after the traqueal intubation|||mmHg||Inter-Quartile Range|Median
637524|NCT02483611|Secondary|MAP - M7d (Mean Arterial Pressure in the Moment 7d)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as 60 minutes after the traqueal intubation. This time point was named as moment '7d'.|This measure of average blood pressure was performed 60 minutes after the traqueal intubation|||mmHg||Inter-Quartile Range|Median
637525|NCT02483611|Secondary|MAP - M7c (Mean Arterial Pressure in the Moment 7c)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as 45 minutes after the traqueal intubation. This time point was named as moment '7c'.|This measure of average blood pressure was performed 45 minutes after the traqueal intubation|||mmHg||Standard Deviation|Mean
637526|NCT02483611|Secondary|MAP - M7b (Mean Arterial Pressure in the Moment 7b)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as 30 minutes after the traqueal intubation. This time point was named as moment '7b'.|This measure of average blood pressure was performed 30 minutes after the traqueal intubation|||mmHg||Inter-Quartile Range|Median
637527|NCT02483611|Secondary|MAP - M7a (Mean Arterial Pressure in the Moment 7a)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as 15 minutes after the traqueal intubation. This time point was named as moment '7a'.|This measure of average blood pressure was performed 15 minutes after the traqueal intubation|||mmHg||Inter-Quartile Range|Median
637709|NCT02475031|Secondary|Average Pain Scores|Post- operative VAS pain scores (range of 0-10. 0 being no pain and 10 being worst pain) will be recorded at 1,12, 24, 36,48 and 60 hours. The values at each time points were combined and averaged.|up to 60 hours|||units on a scale||Standard Error|Mean
637530|NCT02483611|Secondary|HR - M4 (Heart Rate in the Moment 4)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as in the end of the study solutions infusion. This time point was named as moment '4'.|This measure of heart rate was performed five minutes after M3 (in the end of the X and Y solutions infusion)|||beats/min||Standard Deviation|Mean
637531|NCT02483611|Secondary|HR - M3 (Heart Rate in the Moment 3)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as immediately before the start of the infusion of the solution X (magnesium sulfate or isotonic solution) and Y solution (lidocaine or isotonic solution). This time point was named as moment '3'.|This measure of heart rate was performed immediately before the start of the infusion of the solution X (magnesium sulfate or isotonic solution) and Y solution (lidocaine or isotonic solution)|||beats/min||Standard Deviation|Mean
637532|NCT02483611|Secondary|HR - M2 (Heart Rate in the Moment 2)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as in the moment immediately before the anesthesia induction. This time point was named as moment '2'.|This measure of heart rate was performed immediately before induction of anesthesia|||beats/min||Standard Deviation|Mean
637533|NCT02483611|Secondary|HR - M1 (Heart Rate in the Moment 1)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The measure of heart rate was recorded and annotated at various times such as in the arrival of the patient in the operating room. This time point was named as moment '1'.|This measure of heart rate was performed when the patient arrived in the operating room|||beats/min||Standard Deviation|Mean
637534|NCT02483611|Secondary|MAP - M6 (Mean Arterial Pressure in the Moment 6)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as one minute after the tracheal intubation. This time point was named as moment '6'.|This measure of average blood pressure was performed one minute after the tracheal intubation|||mmHg||Inter-Quartile Range|Median
637535|NCT02483611|Secondary|MAP - M5 (Mean Arterial Pressure in the Moment 5)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as immediately before the tracheal intubation. This time point was named as moment '5'.|This measure of average blood pressure was performed immediately before the tracheal intubation|||mmHg||Inter-Quartile Range|Median
637536|NCT02483611|Secondary|MAP - M4 (Mean Arterial Pressure in the Moment 4)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as in the end of the study solutions infusion.This time point was named as moment '4'.|This measure of average blood pressure was performed five minutes after M3 (in the end of the X and Y solutions infusion)|||mmHg||Inter-Quartile Range|Median
637537|NCT02483611|Secondary|MAP - M3 (Mean Arterial Pressure in the Moment 3)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as immediately before the start of the infusion of the solution X (magnesium sulfate or isotonic solution) and Y solution (lidocaine or isotonic solution). This time point was named as moment '3'.|This measure of average blood pressure was performed immediately before the start of the infusion of the solution X (magnesium sulfate or isotonic solution) and Y solution (lidocaine or isotonic solution)|||mmHg||Standard Deviation|Mean
637538|NCT02483611|Secondary|MAP - M2 (Mean Arterial Pressure in the Moment 2)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as in the moment immediately before the anesthesia induction. This time point was named as moment '2'.|This measure of average blood pressure was performed immediately before induction of anesthesia|||mmHg||Standard Deviation|Mean
637539|NCT02483611|Secondary|MAP - M1 (Mean Arterial Pressure in the Moment 1)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as in the arrival of the patient in the operating room. This time point was named as moment '1'.|This measure of average blood pressure was performed when the patient arrived in the operating room|||mmHg||Standard Deviation|Mean
637540|NCT02483611|Primary|Spontaneous Recovery (T4/T1=90%)|"Spontaneous recovery is the elapsed time for the recovery of the TOF (T4 / T1) response to 90% of the original after infusion of cisatracurium.
This outcome measure was presented in minutes."|The participants were followed during the anesthetic - surgical procedure|||minutes||Standard Deviation|Mean
637541|NCT02483611|Primary|Total Duration (Dur95%)|"The total duration is the elapsed time for T1 recovery of the response to reach 95% of the initial after the infusion of cisatracurium.
This outcome measure was presented in minutes."|Participants were followed during the anesthetic - surgical procedure, an average of 90 minutes|The sample size was calculated with a power of 80% to detect differences of 20% in the timing of clinical onset and the duration of NMB. This pharmacodynamic variable was compared between the groups by analysis of variance (Anova one way) and Tukey post-hoc test (p value < 0.05)||minutes||Standard Deviation|Mean
637542|NCT02483611|Primary|Final Recovery Index|"The final recovery index is the elapsed time between the T1 recovery = 25% (Dur25%) and T4 / T1 = 80% (TOF = 80%) after the infusion of cisatracurium.
This outcome measure was presented in minutes."|Participants were followed during the anesthetic - surgical procedure, an average of 90 minutes|The sample size was calculated with a power of 80% to detect differences of 20% in the timing of clinical onset and the duration of NMB. This pharmacodynamic variable was compared between the groups by analysis of variance (Anova one way) and Tukey post-hoc test (p value < 0.05)||minutes||Standard Deviation|Mean
637543|NCT02483611|Primary|Recovery Index|"The recovery index is the elapsed time between the T1 recovery =25% (Dur25%) and T1 =75% (Dur75%) after the infusion of cisatracurium.
This outcome meansure was presented in minutes."|Participants were followed during the anesthetic - surgical procedure, an average of 90 minutes|The sample size was calculated with a power of 80% to detect differences of 20% in the timing of clinical onset and the duration of NMB. This pharmacodynamic variable was compared between the groups by analysis of variance (Anova one way) and Tukey post-hoc test (p value < 0.05)||minutes||Standard Deviation|Mean
637544|NCT02483611|Primary|Clinical Duration|"The clinical duration is the elapsed time for T1 recovery = 25% (Dur25%) of the original value of T1 after the infusion of cisatracurium.
This outcome meansure was presented in minutes."|Participants were followed during the anesthetic - surgical procedure, an average of 90 minutes|The sample size was calculated with a power of 80% to detect differences of 20% in the timing of clinical onset and the duration of NMB. This pharmacodynamic variable was compared between the groups by Kruskal-Wallis test. When differences were found between the groups, we used the Dunn test for multiple comparisons (p value < 0.05)||minutes||Inter-Quartile Range|Median
637545|NCT02483611|Primary|Latency|"The latency is computed as the elapsed time to reduce the response of T1 to 5% of the initial contraction force after the infusion of cisatracurium.
This outcome meansure was presented in seconds."|Participants were followed during the anesthetic - surgical procedure, an average of 90 minutes|The sample size was calculated with a power of 80% to detect differences of 20% in the timing of clinical onset and the duration of NMB. This pharmacodynamic variable was compared between the groups by analysis of variance (Anova one way) and Tukey post-hoc test (p value < 0.05)||seconds||Standard Deviation|Mean
637546|NCT02482428|Secondary|Number of Participants That Had Partial Clearance Rate of at Least 75 Percent Reduction in External Genital Wart (EGW)s Count at End of Treatment (EOT) Week 12 or 16|Number of Participants that had partial clearance rate of at least 75 percent reduction in External Genital Wart (EGW)s count at end of treatment (EOT) Week 12 or 16|End of Treatment (EOT) Week 12 or Week 16|Pharmacodynamics (PD) data sets included all randomized patients For efficacy end points only there were combined analysis of the 2 vehicle groups. Vehicle groups were analyzed separately for safety and tolerability only.||participants|||Number
637547|NCT02482428|Primary|Number of Adverse Events (AE)/Serious Adverse Events (SAE) as a Measure of Safety and Tolerability up to 30 Weeks|Number of participants with at least one AE/SAE in the category up to 30 weeks|30 weeks|The safety analysis set included all patients that received any study drug. For Safety & Tolerability only the 2 vehicles have separate analysis.||participants|||Number
637548|NCT02482428|Primary|Complete Clearance of Disease at Week 14|Number of participants achieving complete clearance of genital warts at Week 14|Week 14|Pharmacodynamics (PD) data sets included all randomized patients For efficacy end points only there were combined analysis of the 2 vehicle groups. Vehicle groups were analyzed separately for safety and tolerability only.||participants|||Number
637549|NCT02482129|Secondary|Number of Subjects With Anti-LME636 Antibodies Present at Each Visit|Serum samples were collected and assessed for anti-LME636 antibodies. Samples collected from subjects in the LME636 dose group were analyzed for anti-LME636 antibodies. For subjects in the dexamethasone group, only the samples collected on Day 1 (ie, prior to the start of treatment) were analyzed for anti-LME636 antibodies.|Day 1, Day 4, Day 8, Day 15, Day 22, Day 29|This analysis population includes all subjects with available immunogenicity data and no protocol deviations with relevant impact on the data (Immunogenicity Set).||Participants|||Count of Participants
637550|NCT02482129|Secondary|Mean Serum Concentration of Total LME636 at Each Visit|Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. Concentrations below the limit of quantification (BLQ), defined as 0.25 ng/mL, were reported as NA with no imputation for missing data.|Baseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29|This analysis population includes all subjects who received investigative product (IP) and had at least 1 evaluable serum sample following IP exposure.(Pharmacokinetics Analysis Set). Number Analyzed is the number of subjects with data at visit.||ng/mL||Standard Deviation|Mean
637551|NCT02482129|Secondary|Use of Rescue Treatment|Use of rescue treatment is presented as the number of subjects with first use of rescue treatment by visit. Subjects receiving rescue medication were not considered withdrawn and the collection of data continued after discontinuation of study treatment. Only one eye contributed to the analysis.|Day 4, Day 8, Day 15|Per Protocol Analysis Set||Participants|||Count of Participants
637552|NCT02482129|Secondary|Time-to-Response|Time-to-Response was defined as the number of days from baseline to the first scheduled visit when a two-step decrease or more from baseline in AC Cell Grade (as per SUN) was observed. Time-to-Response is reported as number of subjects presenting time-to-response by visit. Only one eye contributed to the analysis.|Baseline (Day 1), Up to Day 15|Per Protocol Analysis Set||Participants|||Count of Participants
637553|NCT02482129|Secondary|Mean Change From Baseline in BCVA at Each Visit|Visual Acuity (VA) was measured with the participant's best spectacles or other visual corrective device in place using an ETDRS or Snellen visual acuity chart. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. Only one eye contributed to the analysis.|Baseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29|Safety Analysis Set. Number Analyzed is the number of subjects with data at visit.||letters||Standard Deviation|Mean
637554|NCT02482129|Secondary|Number of Subjects With IOP Change From Baseline to Last On-Treatment Assessment|IOP was assessed using Goldmann applanation tonometry or Tonopen and reported in mmHg. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Only one eye contributed to the analysis.|Baseline (Day 1), Up to Day 29|Safety Analysis Set||Participants|||Count of Participants
637555|NCT02482129|Primary|Number of Subjects With an Increase From Baseline in Dilated Fundus Parameters at Any Post-Treatment Visit|The dilated fundus examination was performed to evaluate the health of the vitreous, optic disc, retinal vessels, macula, and retinal periphery. An increase indicates worsening. Only one eye contributed to the analysis.|Baseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29|Safety Analysis Set||participants|||Number
637556|NCT02482129|Primary|Number of Subjects With Increase From Baseline in Slit Lamp Parameters at Any Post-Treatment Visit|Slit-lamp biomicroscopy (examination) was performed to evaluate the anterior segment of the eye, including lids/lashes, conjunctiva, cornea, anterior chamber (cells and flare), iris, and lens. Ocular signs were categorized as Aqueous Flare, Aqueous Inflammatory Cell Grade, Keratic Precipitates, Lens, Limbal Injection, Status of Lens, Peripheral Anterior Synechia, and Posterior Synechia. An increase indicates worsening. Only one eye contributed to the analysis.|Baseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29|Safety Analysis Set||participants|||Number
637573|NCT02480712|Secondary|Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set||percentage of participants||95% Confidence Interval|Number
637557|NCT02482129|Primary|Mean Intraocular Pressure (IOP) at Each Visit|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry or Tonopen and reported in millimeters mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Only one eye contributed to the analysis.|Baseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29|Safety Analysis Set. Number Analyzed is the number of subjects with data at visit.||mmHg||Standard Deviation|Mean
637558|NCT02482129|Primary|Mean Best Corrected Visual Acuity (BCVA) at Each Visit|Visual Acuity (VA) with the subject's best spectacles or other visual corrective devices was measured using an Early Treatment of Diabetic Retinopathy Study (ETDRS) or Snellen visual acuity chart and reported in letters read correctly. An increase (gain) in letters read indicates improvement. Only one eye contributed to the analysis.|Baseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29|This analysis population includes all subjects who received any study drug (Safety Analysis Set). Number Analyzed is the number of subjects with data at visit.||letters||Standard Deviation|Mean
637559|NCT02482129|Primary|Number of Responders at Day 15|Response was defined as a two-step decrease or more from baseline in Anterior Chamber (AC) Cell Grade as per Standardization of Uveitis Nomenclature (SUN). Baseline was defined as the measurement taken before drug administration on Day 1. Subjects receiving rescue treatment on or before Day 15 were considered non-responders. Only one eye contributed to the analysis.|Baseline (Day 1), Day 15|This analysis population includes all subjects who received any study drug, had at least 1 post-baseline efficacy assessment, had no critical protocol deviations, and had a valid determination of response status for the primary endpoint (Per Protocol Analysis Set).||Participants|||Count of Participants
637560|NCT02481934|Secondary|Number of Participants With Peripheral Blood Monoclonal Protein Reduction or Stabilization|Efficacy will be assessed monthly during NKAE treatment (4 months) by peripheral blood monoclonal protein monitoring. During follow-up, efficacy will be evaluated monthly the first 6 months. After that, quarterly until one year of follow-up.|16 months|||participants|||Number
637561|NCT02481934|Primary|Number of Participants With Adverse Events During NKAE Treatment|Toxicity will be assessed by adverse events count during NKAE treatment monitoring peripheral blood absolute neutrophil count (cells/μl). Toxicity will be evaluated monthly during NKAE treatment (4 months). During follow-up, it will be assessed monthly the first 6 months. After that, quarterly until one year of follow-up, based on Common Toxicity Criteria for Adverse Events of the National Cancer Institute (CTCAE) to v.4.03.|16 months|Analysis per protocol||participants|||Number
637562|NCT02481219|Secondary|Adverse Events Rate Between Two Different Bowel Preparation Methods for PillCam CCE|Will be assesses by applicable CRF|Adverse Events (AE) were collected starting from the screening visit and until 5-9 days following the PillCam procedure day.|Full analysis set||percentage of participants with >1 AE|||Number
637563|NCT02481219|Secondary|Excretion Rate of Capsule Within 12 Hours of Two Different Bowel Preparation Methods for PillCam CCE|Will be assesses by applicable case report form (CRF)|an expected average of 3 weeks from study procedure|PPAS: Subjects withdrawn prior to the PillCam procedure (3) and subjects with one or more of the following protocol deviations (13) have been excluded: Evening PEG intake <1h and > 2.15h, Morning PEG intake <1h and >2:15 h, Capsule ingestion l<45 min or >75 min after PEG intake , Overall PEG intake volume is less than 3 liters||percentage of participants|||Number
637564|NCT02481219|Secondary|Comparing of Completion Rate of Capsule of Two Different Bowel Preparation Methods for PillCam CCE|Will be assessed from RAPID video in total and by segment|an expected average of 3 weeks from study procedure|Per protocol analysis set||percentage of participants|||Number
637565|NCT02481219|Secondary|Colonic Transit Time of Two Different Bowel Preparation Methods for PillCam CCE|Colonic transit time of two different bowel preparation was assessed from RAPID video in total and by segment|an expected average of 3 weeks from study procedure|The following patients were excluded from the analysis:2 withdrawn patients, 1 LTF (Lost to follow-up) patient, 2 pattients with failed prcedure, 16 patients with incomplete COLON exam.||hours||Full Range|Median
637566|NCT02481219|Secondary|Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE|Will be assessed from RAPID video in total and by segment|an expected average of 3 weeks from study procedure|This analysis is a subset of the PPAs excluding patients with one or more missing video data for Cecum, Ascending and transverse colon. Patients with at least one polyp detected on overall segments.||percentage of participants|||Number
637567|NCT02481219|Primary|Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE)|The primary endpoint is the bowel cleansing level, as determined by a standardized 4-point grading scale, assessed in total and by segment (cecum, ascending, transverse, descending/sigmoid, and rectum).|Within two weeks of study procedure|this was calculated on the per protocol analysis (PPAS) set excluding patients with one (or more) unseen segment in Cecum, Ascending and Transverse colon.||percentage of particpants|||Number
637568|NCT02480712|Secondary|Serum Creatinine Change From Baseline At the End of Treatment and At Posttreatment Week 12||Week 12; Posttreatment Week 12|"Participants in the Safety Analysis Set with available data were analyzed by TDF-containing ART at baseline:
Boosted TDF-containing regimens
Non-boosted TDF-containing regimens
Non TDF-containing regimens"||mg/dL||Standard Deviation|Mean
637569|NCT02480712|Secondary|Percentage of Participants That Maintained HIV-1 RNA < 50 Copies/mL While On HCV Treatment||Up to 12 Weeks|"Participants in the Safety Analysis Set with available data were analyzed by TDF-containing ART at baseline:
Boosted TDF-containing regimens
Non-boosted TDF-containing regimens
Non TDF-containing regimens"||percentage of participants|||Number
637570|NCT02480712|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as:
On-treatment virologic failure:
Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)
Virologic relapse:
Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit"|Up to Posttreatment Week 24|Full Analysis Set||percentage of participants|||Number
637571|NCT02480712|Secondary|HCV RNA Change From Baseline/Day 1||Baseline to Week 12|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
637572|NCT02480712|Secondary|Percentage of Participants With HCV RNA < LLOQ on Treatment||Up to 12 Weeks|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants||95% Confidence Interval|Number
637576|NCT02480582|Secondary|24 Hour Energy Intake|Measured reductions in total within-day energy intake following consumption of almonds as a mid-morning snack compared to control and comparator. Food will be weighed pre- and post-consumption to the nearest 0.1g, at every test meal, to determine energy intake. Total energy intake will then be calculated. 24 hour energy intake will be measured on three occasions, on average a week apart.|3 Weeks|||kcal||Standard Deviation|Mean
637577|NCT02480582|Secondary|Appetite Sensations (Hunger)|"Measured differences in hunger following consumption of almonds as a mid-morning snack compared to control and comparator.
Appetite sensations will be measured during the three intervention conditions at regular time intervals from the morning to the evening (21 in total) using 100-mm visual analogue scale (VAS).
Scale range = 0-100 mm, with higher values indicating greater hunger. Total Area Under the Curve will be calculated from the VAS profiles using the trapeziodal method.
Time points at which data were collected to calculate AUC - -5, 15, 30, 60, 90, 120, 135, 180, 230, 240, 270, 280, 300, 360, 420, 480, 510, 540, 600; -5 to 8 hours post intervention.
Higher AUC scores on hunger are interpreted as a worse outcome."|3 Weeks|||minutues*mm||Standard Deviation|Mean
637578|NCT02480582|Secondary|Food Preference|"Measured changes in wanting for high fat food food following consumption of almonds as a mid-morning snack compared to control and comparator.
Food preference will be measured once during each intervention condition using the Leeds Food Preference Questionnaire (LFPQ: Finlayson, King & Blundell, 2008).
8 high fat foods and 8 low fat foods are presented on a computer and participants rate the extent to which they want each food (How much do you want this food now?). The food images are presented individually, in a randomised order and participants make their ratings using a 100-mm VAS. Low fat scores are subtracted from high fat scores to provide a relative preference score.
Scale range: -100 to 100. Higher scores indicate greater wanting for high fat foods which is interpreted as a worse outcome."|3 Weeks|||units on a scale||Standard Deviation|Mean
637579|NCT02480582|Primary|Test Meal Energy Intake|Measured reductions in ad-libitum energy intake following consumption of almonds as a mid-morning snack compared to control and comparator. Food will be weighed pre- and post-consumption to the nearest 0.1g to determine energy intake. Test meal energy intake will be measured on three occasions, on average a week apart.|3 Weeks|||kcal||Standard Deviation|Mean
637580|NCT02480439|Secondary|Percentage of Participants With Markedly Abnormal Vital Sign Values at Least Once Post-dose|Vital signs included body temperature (oral), sitting blood pressure (after 5 minutes resting), respiration rate and pulse (beats per minute [bpm]).|First dose of study drug to 7 days after the last dose of study drug (Up to Day 24)|Safety Set included of all participants who were enrolled and received at least 1 dose of study drug.||percentage of participants|||Number
637581|NCT02480439|Secondary|Percentage of Participants With Markedly Abnormal Laboratory Values at Least Once Post-dose||First dose of study drug to 7 days after the last dose of study drug (Up to Day 24)|Safety Set included of all participants who were enrolled and received at least 1 dose of study drug.||percentage of participants|||Number
637582|NCT02480439|Secondary|Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|First dose of study drug to 30 days after the last dose of study drug (Up to Day 47)|Safety Set included of all participants who were enrolled and received at least 1 dose of study drug.||percentage of participants|||Number
637583|NCT02480439|Primary|AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-648||Day 1 pre-dose and multiple timepoints post-dose (Up to 72 hours) in each Period|The PK Set included all participants who received at least 1 dose of study drug and had at least 1 measurable postdose plasma concentration.||ng*hr/mL||Standard Deviation|Mean
637584|NCT02480439|Primary|AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-648||Day 1 pre-dose and multiple timepoints post-dose (Up to 72 hours) in each Period|The PK Set included all participants who received at least 1 dose of study drug and had at least 1 measurable postdose plasma concentration.||ng*hr/mL||Standard Deviation|Mean
637585|NCT02480439|Primary|Cmax: Maximum Observed Plasma Concentration for TAK-648||Day 1 pre-dose and multiple timepoints post-dose (Up to 72 hours) in each Period|The PK Set included all participants who received at least 1 dose of study drug and had at least 1 measurable postdose plasma concentration.||mg/mL||Standard Deviation|Mean
637586|NCT02480166|Secondary|Number of Participants Who Experienced Serious Adverse Events (SAEs) and/or Adverse Events (AEs) From Informed Consent to 12 Weeks Post-treatment.|Adverse events were defined using Common Terminology Criteria for Adverse Events v3.0 (CTCAE)|Day 1 of treatment to 12 weeks post treatment|||Participants|||Count of Participants
637587|NCT02480166|Primary|Number of Participants With a Sustained Virologic Response (SVR) log10 HCV RNA PCR <25 IU/mL 12 Weeks Post-treatment||12 weeks after end of therapy|||Participants|||Count of Participants
637589|NCT02480010|Secondary|Mean Residence Time (MRT) of Pertuzumab|MRT is the average time that pertuzumab is present in the systemic circulation and is measured in days.|Cycles 1 and 2 (Weeks 3 and 6): predose (immediately prior to infusion) and within 15 minutes following the end of the infusion on Day 1, Day 8, and Day 15. Cycle 3 (Week 9) and beyond: predose and within 15 minutes following end of infusion on Day 1|ITT Population; Only participants with non-missing data were included in the analysis.||days||Geometric Coefficient of Variation|Geometric Mean
637693|NCT02475564|Secondary|Serum Prolactin Levels at 42 Days|Serum levels of prolactin will be measured after 42 days of treatment. Median levels of prolactin were compared between both groups on day 42.|42 days|one of the subjects in the placebo group decided to leave the study after randomization, thus n = 21||ng/mL||Full Range|Median
637590|NCT02480010|Secondary|Volume of Distribution at Steady State of Pertuzumab|The volume of distribution at steady state (Vss), also known as apparent volume of distribution, is a pharmacological, theoretical volume that the total amount of administered drug would have to occupy (if it were uniformly distributed), to provide the same concentration as it currently is in blood plasma.|Cycles 1 and 2 (Weeks 3 and 6): predose (immediately prior to infusion) and within 15 minutes following the end of the infusion on Day 1, Day 8, and Day 15. Cycle 3 (Week 9) and beyond: predose and within 15 minutes following end of infusion on Day 1|ITT Population; Only participants with non-missing data were included in the analysis.||mL||Geometric Coefficient of Variation|Geometric Mean
637591|NCT02480010|Secondary|Serum Clearance of Pertuzumab|Clearance (expressed as volume/time) describes the removal of drug from a volume of plasma in a given unit of time (drug loss from the body). It is measured as milliliters per day (mL/day).|Cycles 1 and 2 (Weeks 3 and 6): predose (immediately prior to infusion) and within 15 minutes following the end of the infusion on Day 1, Day 8, and Day 15. Cycle 3 (Week 9) and beyond: predose and within 15 minutes following end of infusion on Day 1|ITT Population; Only participants with non-missing data were included in the analysis.||mL/day||Geometric Coefficient of Variation|Geometric Mean
637592|NCT02480010|Secondary|Terminal Elimination Half-Life (t1/2) of Pertuzumab|t1/2 is the time in days required for the concentration of the drug to reach half of its original value|Cycles 1 and 2 (Weeks 3 and 6): predose (immediately prior to infusion) and within 15 minutes following the end of the infusion on Day 1, Day 8, and Day 15. Cycle 3 (Week 9) and beyond: predose and within 15 minutes following end of infusion on Day 1|ITT Population; Only participants with non-missing data were included in the analysis.||days||Geometric Coefficient of Variation|Geometric Mean
637593|NCT02480010|Secondary|Time to Maximum Plasma Concentration (Tmax) of Pertuzumab|Cmax refers to the maximum (or peak) plasma concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administered and prior to the administration of a second dose. tmax is the time at which the Cmax is observed.|Cycles 1 and 2 (Weeks 3 and 6): predose (immediately prior to infusion) and within 15 minutes following the end of the infusion on Day 1 and on Days 8 and 15, Cycle 3 (Week 9) and beyond: predose and within 15 minutes following end of infusion on Day 1|ITT Population||days||Geometric Coefficient of Variation|Geometric Mean
637594|NCT02480010|Secondary|Maximum Plasma Concentration of Pertuzumab|Cmax is the maximum (or peak) plasma concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administered and prior to the administration of a second dose. Cmax is measured as micrograms per mL (μg/mL).|Cycles 1 and 2 (Weeks 3 and 6): predose (immediately prior to infusion) and within 15 minutes following the end of the infusion on Day 1, Day 8, and Day 15. Cycle 3 (Week 9) and beyond: predose and within 15 minutes following end of infusion on Day 1|ITT Population||μg/mL||Geometric Coefficient of Variation|Geometric Mean
637595|NCT02480010|Secondary|AUC to Last Measurable Concentration (AUC0-last) of Pertuzumab|The AUC0-last is calculated from time 0 (prior to administration of medication) to last measured data point. The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption.|Cycles 1 and 2 (Weeks 3 and 6): predose (immediately prior to infusion) and within 15 minutes following the end of the infusion on Day 1, Day 8, and Day 15. Cycle 3 (Week 9) and beyond: predose and within 15 minutes following end of infusion on Day 1|ITT Population||µg*day/mL||Geometric Coefficient of Variation|Geometric Mean
637596|NCT02480010|Secondary|Area Under the Concentration Curve Extrapolated to Infinity (AUC0-Inf) of Pertuzumab|The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC0-infinity is calculated from time 0 (prior to administration of medication) to infinity (the time of complete elimination of the drug). The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. AUC is measured as micrograms times days per milliliter (µg*day/mL)|Cycles 1 and 2 (Weeks 3 and 6): predose (immediately prior to infusion) and within 15 minutes following the end of the infusion on Day 1, Day 8, and Day 15. Cycle 3 (Week 9) and beyond: predose and within 15 minutes following end of infusion on Day 1|ITT Population; Only participants with non-missing data were included in the analysis.||µg*day/mL||Geometric Coefficient of Variation|Geometric Mean
637597|NCT02480010|Secondary|Change From Baseline in N-Telopeptide|In bone physiology, the N-terminal telopeptide (or more formally, amino-terminal collagen crosslinks, and known by the acronym NTX) is a telopeptide that can be used as a biomarker to measure the rate of bone turnover. NTX can be measured in the urine (uNTX) or serum (serum NTX).|Screening, Weeks 6, 12, 24, 36 and 48|Data were not analyzed to due to early termination of the study.|||||
637598|NCT02480010|Secondary|Change From Baseline in Bone Alkaline Phosphatase|Bone alkaline phosphatase (BAP) is the bone-specific isoform of alkaline phosphatase. Serum Bone alkaline phosphatase is used to measure osteoporosis and is measured as units per liter (u/L).|Screening, Weeks 6, 12, 24, 36 and 48|Data were not analyzed to due to early termination of the study.|||||
637599|NCT02480010|Secondary|Time to Treatment Failure|Time to Treatment Failure was time to the first documentation of progressive disease, day of death while on study (or 30 days after withdrawing from the trial) or day of early discontinuation due to toxicity (adverse events or abnormal laboratory value), refusal of treatment/refusing to cooperate/withdrawing consent, insufficient therapeutic response, or failure to return, whichever is earliest, after the start of treatment. Participants who did not experience any of the above events while on study were censored on the day of their last PSA or tumor measurement, whichever was later.|Every 3 weeks up to a maximum of 18 weeks|ITT Population||days||Full Range|Median
637600|NCT02480010|Secondary|Overall Survival|Overall survival was defined as the interval of time in weeks between start of treatment and day of death. Participants who did not die while being followed were censored at the last time that they were known to be alive.|Screening, Every 3 weeks up to a maximum of 18 months|Data were not analyzed due to early termination of the study.|||||
637601|NCT02480010|Secondary|Time to Prostate Cancer Pain Progression|Time to disease progression was defined by time in weeks from start of therapy to the onset of the earliest of the following events: 1) Opioid therapy, 2) Radiation therapy, 3) Glucocorticoid therapy, 4) Radionuclide therapy or 5) Chemotherapy.|Every 3 weeks up to a maximum of 18 weeks|This analysis was only planned if either cohort went to full recruitment. Analysis of this outcome in a small number of participants would have high variability and also unlikely to be relevant if safety and tolerability criteria were not met.|||||
640959|NCT02327117|Primary|Hb Level 48 Hours After Total Knee Arthroplasty||48 hours after TKA|||gr/dL||Standard Deviation|Mean
637602|NCT02480010|Secondary|Percentage of Participants Without Progression|Disease progression was defined as the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Non-progression included participants who had responded plus those who had not responded and not progressed within the first 3 cycles.|Screening, Weeks 3, 6, 9 and 12|ITT population||percentage of participants|||Number
637603|NCT02480010|Secondary|Duration of Response According to RECIST Criteria|For participants with measurable disease, duration of response was defined as first documentation of tumor response, either a PR or CR, to first documentation of PD or death. Participants who never progressed or died were censored at their last tumor measurement.|Baseline, Weeks 6, 12, 24, 36 and 48|This analysis was only planned if either cohort went to full recruitment. Analysis of this outcome in a small number of participants would have high variability and also unlikely to be relevant if safety and tolerability criteria were not met.|||||
637604|NCT02480010|Secondary|Duration of Response According to PSA Levels|Duration of PSA Response was measured from first 50% decline in PSA compared to baseline until the time at which there was an increase of ≥50% from the PSA nadir, provided the absolute increase was at least 5 nanograms per milliliter (ng/ml). The increase must have been confirmed by a second consecutive measurement that was at least 50% above the nadir.|Baseline, Every 3 weeks for a maximum of 18 months|This analysis was only planned if either cohort went to full recruitment. Analysis of this outcome in a small number of participants would have high variability and also unlikely to be relevant if safety and tolerability criteria were not met.|||||
637605|NCT02480010|Secondary|Time to Response|Time to response was the date of the first documentation of PSA response.|Screening, Every 3 weeks for a maximum of 18 months|This analysis was only planned if either cohort went to full recruitment. Analysis of this outcome in a small number of participants would have high variability and also unlikely to be relevant if safety and tolerability criteria were not met.|||||
637606|NCT02480010|Secondary|Percentage of Participants With Objective Response (Complete Response [CR] or Partial Response [PR]) by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria|Overall objective response by RECIST criteria (CR or PR) was to be defined for participants who had measurable disease at baseline or developed new lesions post-baseline. The longest diameter only for all target lesions was measured and the following responses recorded: CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the longest diameter as compared to the baseline sum longest diameter.|Screening, Weeks 6, 12, 24, 36 and 48|This analysis was only planned if either cohort went to full recruitment. Analysis of this outcome in a small number of participants would have high variability and also unlikely to be relevant if safety and tolerability criteria were not met.|||||
637607|NCT02480010|Secondary|Time to Disease Progression|Time to disease progression was defined by time in weeks from start of therapy to the onset of the earliest of the following events. 1) PSA progression as defined by the PSAWG, 2) Evidence of disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria 3) One bone scan at least 6 months subsequent to baseline demonstrating 2 or more new skeletal lesions and 4) An event due to metastatic prostate cancer requiring intervention.|Screening, Every 3 weeks up to a maximum of 18 months|ITT population||weeks||Full Range|Median
637608|NCT02480010|Primary|Percentage of Participants With Confirmed, Objective Response, Non-Response or Progressive Disease by PSA Levels Within the First 24 Weeks of Treatment With Pertuzumab|Objective PSA response rate was determined according to Prostate Specific Antigen Working Group (PSAWG) guidelines. All participants achieving a drop in PSA of greater than or equal to (≥) 50 percent (%) from baseline (confirmed with a second value at least 4 weeks later) fulfilled the criteria of a PSA response. The confirmatory second value had to be at least 50% lower than baseline, but could be higher than the first drop in PSA. Confirmatory value could not be 50% higher compared to first drop in PSA. The date of response was the date the first 50% (or greater) decline was observed. Progressive disease (PD) was defined by a minimum of three consecutive serum PSA measurements obtained at least 7 days apart within the previous 3 months of start of trial, which documented progressively increasing values. Non-response was defined as neither PD nor Response.|Screening, Every 3 weeks up to Week 24|ITT population||percentage of participants|||Number
637609|NCT02479763|Primary|Percentage of Patients With Successful Epidural Blocks|Fifteen minutes after the LA injection, a blinded observer will apply ice to the T1-L4 dermatomes and assess the epidural block. The criterion standard for success will be the presence of an epidural block (defined as a block to ice in at least 2 dermatomes bilaterally). If the operators cannot thread the catheter after 2 attempts, epidural blocks will considered failures.|up to 15 minutes after the procedure|||percentage of patients|||Number
637610|NCT02479412|Secondary|Rate and Extent of Absorption of Three Dose Levels of AZD7594 Following Multiple Dose Administration by Assessment of Cmin of AZD7594|Comparison of steady-state minimum (pre-dose) concentration (Cmin) of AZD7594 in each treatment period|On Day 14 at pre-dose in each period|The subset of all randomized participants, 24-hour PK sampling was performed on Day 14, primary PK parameters (Cmax , AUC(0-4), Cmax,ss, AUC(0-24)) were calculated in at least one treatment period, and who had no major protocol deviations considered to impact the analysis of the PK data. Cmin was not determined for AZD7594 58 μg||pmol/L||Geometric Coefficient of Variation|Geometric Mean
637611|NCT02479412|Secondary|Rate and Extent of Absorption of Three Dose Levels of AZD7594 Following Multiple Dose Administration by Assessment of AUC(0-24)/D of AZD7594|Comparison of AUC(0-24)/D (dose-normalized AUC(0-24)) of AZD7594|On Day 14 in each period|PKS included the subset of all randomized participants for whom 24-hour PK sampling was performed on Day 14, for whom the primary PK parameters (Cmax , AUC(0-4), Cmax,ss, AUC(0-24)) were calculated in at least one treatment period, and who had no major protocol deviations considered to impact the analysis of the PK data.||h×pmol/L/ μmol||Geometric Coefficient of Variation|Geometric Mean
637612|NCT02479412|Secondary|Rate and Extent of Absorption of Three Dose Levels of AZD7594 Following Multiple Dose Administration by Assessment of Cmax/D of AZD7594|Comparison of Cmax/D (dose-normalized Cmax) of AZD7594|On Day 1 in each period|PKS included the subset of all randomized participants for whom 24-hour PK sampling was performed on Day 14, for whom the primary PK parameters (Cmax , AUC(0-4), Cmax,ss, AUC(0-24)) were calculated in at least one treatment period, and who had no major protocol deviations considered to impact the analysis of the PK data.||pmol/L/μmol||Geometric Coefficient of Variation|Geometric Mean
638006|NCT02457611|Secondary|Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Study Treatment (SVR4)|SVR4 was defined as HCV RNA < LLOQ 4 weeks after the last dose of study drug.|Posttreatment Week 4|Full Analysis Set||percentage of participants||95% Confidence Interval|Number
637613|NCT02479412|Secondary|Rate and Extent of Absorption of Three Dose Levels of AZD7594 Following Multiple Dose Administration by Assessment of Cavg,ss of AZD7594|Comparison of Cavg,ss (average plasma concentration during a dosing interval at steady state) of AZD7594 on Day 14 of each treatment period; up to 10 samples were collected in each period (i.e. in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, 4, 8, 12, 16 and 24 h post-dose)|On Day 14 in each period (in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, 4, 8, 12, 16 and 24 h post-dose)|PKS included the subset of all randomized participants for whom 24-hour PK sampling was performed on Day 14, for whom the primary PK parameters (Cmax , AUC(0-4), Cmax,ss, AUC(0-24)) were calculated in at least one treatment period, and who had no major protocol deviations considered to impact the analysis of the PK data.||pmol/L|pmol/L|Geometric Coefficient of Variation|Geometric Mean
637614|NCT02479412|Secondary|Rate and Extent of Absorption of Three Dose Levels of AZD7594 Following Multiple Dose Administration by Assessment of Tmax,ss of AZD7594|Comparison of tmax,ss (time to reach maximum plasma concentration at steady state) of AZD7594 on Day 14 of each treatment period; up to 10 samples were collected in each period (i.e. in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, 4, 8, 12, 16 and 24 h post-dose)|On Day 14 in each period (in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, 4, 8, 12, 16 and 24 h post-dose)|PKS included the subset of all randomized participants for whom 24-hour PK sampling was performed on Day 14, for whom the primary PK parameters (Cmax , AUC(0-4), Cmax,ss, AUC(0-24)) were calculated in at least one treatment period, and who had no major protocol deviations considered to impact the analysis of the PK data.||Hour||Full Range|Median
637615|NCT02479412|Secondary|Rate and Extent of Absorption of Three Dose Levels of AZD7594 by Assessment of Tmax of AZD7594|Comparison of tmax (time to reach maximum plasma concentration) of AZD7594 on Day 1 of each treatment period; up to 6 samples were collected in each period (i.e. in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, and 4 h post-dose)|On Day 1 in each period (in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, and 4 h post-dose)|PKS included the subset of all randomized participants for whom 24-hour PK sampling was performed on Day 14, for whom the primary PK parameters (Cmax , AUC(0-4), Cmax,ss, AUC(0-24)) were calculated in at least one treatment period, and who had no major protocol deviations considered to impact the analysis of the PK data.||Hour||Full Range|Median
637616|NCT02479412|Secondary|Rate and Extent of Absorption of Three Dose Levels of AZD7594 Following Multiple Dose Administration by Assessment of AUC(0-last) of AZD7594|Comparison of AUC(0-last) (Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (Day 1 and Day 14)) of AZD7594 (i.e. in participants with intensive pharmacokinetic assessments)|On Day 1 and Day 14 in each period (in participants with intensive pharmacokinetic assessments, on Day 1 at pre-dose and 15 and 30 minutes, and 1, 2 and 4 h post-dose, on Day 14 at pre-dose and 15 and 30 minutes, and 1, 2, 4, 8, 12, 16 and 24 h post-dose)|PKS included the subset of all randomized participants for whom 24-hour PK sampling was performed on Day 14, for whom the primary PK parameters (Cmax , AUC(0-4), Cmax,ss, AUC(0-24)) were calculated in at least one treatment period, and who had no major protocol deviations considered to impact the analysis of the PK data.||h*pmol/L||Geometric Coefficient of Variation|Geometric Mean
637617|NCT02479412|Secondary|Rate and Extent of Absorption of Three Dose Levels of AZD7594 Following Multiple Dose Administration by Assessment of AUC(0-24) of AZD7594|Comparison of AUC(0-24) (Area under the plasma concentration-time curve from time zero to 24 hours after administration) of AZD7594 on Day 14 of each treatment period; up to 10 samples were collected in each period (i.e. in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, 4, 8, 12, 16 and 24 h post-dose)|On Day 14 in each period (in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, 4, 8, 12, 16 and 24 h post-dose)|PKS included the subset of all randomized participants for whom 24-hour PK sampling was performed on Day 14, for whom the primary PK parameters (Cmax , AUC(0-4), Cmax,ss, AUC(0-24)) were calculated in at least one treatment period, and who had no major protocol deviations considered to impact the analysis of the PK data.||h×pmol/L||Geometric Coefficient of Variation|Geometric Mean
637618|NCT02479412|Secondary|Rate and Extent of Absorption of Three Dose Levels of AZD7594 Following Multiple Dose Administration by Assessment of Cmax,ss of AZD7594|Comparison of Cmax,ss (observed maximum plasma concentration at steady state) of AZD7594 on Day 14 of each treatment period; up to 10 samples were collected in each period (i.e. in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, 4, 8, 12, 16 and 24 h post-dose)|On Day 14 in each period (in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, 4, 8, 12, 16 and 24 h post-dose)|PKS included the subset of all randomized participants for whom 24-hour PK sampling was performed on Day 14, for whom the primary PK parameters (Cmax , AUC(0-4), Cmax,ss, AUC(0-24)) were calculated in at least one treatment period, and who had no major protocol deviations considered to impact the analysis of the PK data.||pmol/L||Geometric Coefficient of Variation|Geometric Mean
637619|NCT02479412|Secondary|Rate and Extent of Absorption of Three Dose Levels of AZD7594 by Assessment of AUC(0-4) of AZD7594|Comparison of AUC(0-4) (Area under the plasma concentration-time curve from time zero to 4 hours after administration) of AZD7594 on Day 1 of each treatment period; up to 6 samples were collected in each period (i.e. in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, and 4 h post-dose).|On Day 1 in each period (in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, and 4 h post-dose)|The subset of all randomized participants; 24-hour PK sampling was performed on Day 14, the primary PK parameters (Cmax , AUC(0-4), Cmax,ss, AUC(0-24)) were calculated in at least one treatment period, and who had no major protocol deviations considered to impact the analysis of the PK data.||h×pmol/L||Geometric Coefficient of Variation|Geometric Mean
637694|NCT02475564|Secondary|Serum CA125 Levels at 42 Days|Serum levels of CA125 will be measured after 42 days of treatment in UI/mL. Median levels of CA125 were compared between both groups on day 42, and to baseline values (day 1).|42 days|One of subjects from the placebo group decided to leave the study after randomization, thus the n = 21 in the CA125 levels.||UI/mL||Full Range|Median
638007|NCT02457611|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 6 weeks|Safety Analysis Set||percentage of participants|||Number
637620|NCT02479412|Secondary|Rate and Extent of Absorption of Three Dose Levels of AZD7594 by Assessment of Cmax of AZD7594|Comparison of Cmax (maximum observed plasma concentration) of AZD7594 on Day 1 of each treatment period; up to 6 samples were collected in each period (i.e. in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, and 4 h post-dose)|On Day 1 in each period (in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, and 4 h post-dose)|The PK analysis set (PKS) included the subset of all randomized participants for whom 24-hour PK sampling was performed on Day 14, for whom the primary PK parameters (Cmax , AUC(0-4), Cmax,ss, AUC(0-24)) were calculated in at least one treatment period, and who had no major protocol deviations considered to impact the analysis of the PK data.||pmol/L||Geometric Coefficient of Variation|Geometric Mean
637621|NCT02479412|Secondary|Number of Participants With Adverse Events|Assessment of safety and tolerability of three dose levels of AZD7594 in participants with mild to moderate asthma. IP referred to investigational product.|From Screening to Follow-up (these two examinations are up to 165 days apart)|The safety analysis set (SAF) included all randomized participants who received at least one dose of randomized study drug during the treatment periods of the study. This analysis set was classified by actual treatment received. If no participants received incorrect treatment then the SAF was identical to the FAS.||Number of participants|||Number
637622|NCT02479412|Secondary|Efficacy of AZD7594 by Assessment of Asthma Control Days|The efficacy of AZD7594 was assessed in terms of amount of asthma control days in each treatment period. An asthma control day was defined as a day with asthma symptom score = 0, a night with no awakenings due to asthma symptoms and a day with no use of rescue medication. A given calendar day was defined as an asthma control day if it fulfills the criteria for a symptom-free day and for a rescue medication-free day|At baseline and from Day 1 to Day 14 post-dose in each period|All randomized participants who received at least one dose of randomized study drug, were included in the FAS, following the principle of ITT. Participants were included in the analysis according to the treatment to which they were randomized.||Asthma control days||95% Confidence Interval|Least Squares Mean
637623|NCT02479412|Secondary|Efficacy of AZD7594 by Assessment of Daily Symptom Score|The efficacy of AZD7594 was assessed in terms of change in daily symptom score from baseline to average of treatment period post dose (Day 1-14) in each treatment period. Severity scores for asthma symptoms were recorded twice daily, once in the morning and once in the evening with the scoring system of 0-no asthma symptoms, 1-toleratable asthma symptoms, 2-discomfort asthma symptoms with normal activities (or with sleep) and 3-asthma symptoms with impaired normal activities (or to sleep).|At baseline and from Day 1 to Day 14 in each period|All randomized participants who received at least one dose of randomized study drug, were included in the FAS, following the principle of ITT. Participants were included in the analysis according to the treatment to which they were randomized.||Unit on a scale||95% Confidence Interval|Least Squares Mean
637624|NCT02479412|Secondary|Efficacy of AZD7594 by Assessment of Night-time Awakenings|"The efficacy of AZD7594 was assessed in terms of change in nighttime awakenings in each treatment period. The patients were asked to answer ‘Yes’ or ‘No’ to the question of Did your asthma cause you to wake up last night?”. If yes, the number and percentage of days that had a night-time awakening were determined for each of the study periods."|At baseline and from Day 2 to Day 15 in each period|All randomized participants who received at least one dose of randomized study drug, were included in the FAS, following the principle of ITT. Participants were included in the analysis according to the treatment to which they were randomized.||Number of nighttime awakenings||95% Confidence Interval|Least Squares Mean
637625|NCT02479412|Secondary|Efficacy of AZD7594 by Assessment of the Change From Baseline to Day 8 in Asthma Control Questionnaire-5|The efficacy of AZD7594 was assessed in terms of change from baseline to Day 15 in Asthma Control Questionnaire-5 in each treatment period. Five questions were asked and each question was scored on a scale of 0 to 6, where a lower score represents a more severe impairment/symptom. The ACQ-5 score at a given visit was defined as the average of the scores given for each of the questions, calculated as ACQ-5 score = Sum of 5 scores/5.|At baseline and on Day 8 in each period|All randomized participants who received at least one dose of randomized study drug, were included in the FAS, following the principle of ITT. Participants were included in the analysis according to the treatment to which they were randomized.||Unit on a scale||95% Confidence Interval|Least Squares Mean
637626|NCT02479412|Secondary|Efficacy of AZD7594 by Assessment of the Change From Baseline to Day 15 in Asthma Control Questionnaire-5|The efficacy of AZD7594 was assessed in terms of change from baseline to Day 15 in Asthma Control Questionnaire-5 in each treatment period. Five questions were asked and each question was scored on a scale of 0 to 6, where a higher score represents a more severe impairment/symptom. The ACQ-5 score at a given visit was defined as the average of the scores given for each of the questions, calculated as ACQ-5 score = Sum of 5 scores/5.|At baseline and on Day 15 in each period|All randomized participants who received at least one dose of randomized study drug, were included in the FAS, following the principle of ITT. Participants were included in the analysis according to the treatment to which they were randomized.||Unit on a scale||95% Confidence Interval|Least Squares Mean
637627|NCT02479412|Secondary|Efficacy of AZD7594 by Assessment of the Change From Baseline in Average Daily Use of Rescue Salbutamol Over the Treatment Period|The efficacy of AZD7594 was assessed in terms of change from baseline in average daily use of salbutamol (each morning and evening) in each treatment period.|Every day from Day 1 to Day 15 (from evening of Day 1 to morning of Day 15)|All randomized participants who received at least one dose of randomized study drug, were included in the FAS, following the principle of ITT. Participants were included in the analysis according to the treatment to which they were randomized.||Number of inhalations per day||95% Confidence Interval|Least Squares Mean
637628|NCT02479412|Secondary|Efficacy of AZD7594 by Assessment of the Change From Baseline in Evening Peak Expiratory Flow (ePEF) Before Administration Over the Treatment Period|The efficacy of AZD7594 was assessed in terms of change from baseline in evening peak expiratory flow (ePEF) in each treatment period. The first PEF measurement was on the evening of Visit 1. Every morning and every evening after Visit 1, patients were required to perform 3 maneuvers for PEF assessment. The highest value from among the 3 assessments was marked as ePEF together with the date and time of the measurement. The final PEF assessment was done on the morning of Visit 11 (Day 15 of Treatment Period 3).|Every evening from Day 1 to Day 14 in each period|All randomized participants who received at least one dose of randomized study drug, were included in the FAS, following the principle of ITT. Participants were included in the analysis according to the treatment to which they were randomized.||L/min||95% Confidence Interval|Least Squares Mean
637629|NCT02479412|Secondary|Efficacy of AZD7594 by Assessment of the Change From Baseline in Morning Peak Expiratory Flow (mPEF) Before Administration Over the Treatment Period|The efficacy of AZD7594 was assessed in terms of change from baseline in morning peak expiratory flow (mPEF) before administration of the investigational medicinal product (IMP) in each treatment period. The first PEF measurement was on the evening of Visit 1. Every morning and every evening after Visit 1, patients were required to perform 3 maneuvers for PEF assessment. The highest value from among the 3 assessments was marked as mPEF with the date and time of the measurement. The final PEF assessment was done on the morning of Visit 11 (Day 15 of Treatment Period 3).|Every morning at pre-dose from Day 1 to Day 15|All randomized participants who received at least one dose of randomized study drug, were included in the FAS, following the principle of ITT. Participants were included in the analysis according to the treatment to which they were randomized.||L/min||95% Confidence Interval|Least Squares Mean
637630|NCT02479412|Secondary|Efficacy of AZD7594 by Assessment of the Change From Baseline in Trough Forced Vital Capacity (FVC) on Day 8|The efficacy of AZD7594 was assessed in terms of change from baseline in morning trough forced vital capacity (FVC) on Day 8 (defined as the average of the values at 23:00 and 23:30 hours after last dose of investigational medicinal product [IMP] on Day 7)|On Day 1 (pre-dose) and on Day 8 (pre-dose) in each period|All randomized participants who received at least one dose of randomized study drug, were included in the FAS, following the principle of ITT. Participants were included in the analysis according to the treatment to which they were randomized.||Liters||95% Confidence Interval|Least Squares Mean
637631|NCT02479412|Secondary|Efficacy of AZD7594 by Assessment of the Change From Baseline in Trough Forced Vital Capacity (FVC) on Day 15|The efficacy of AZD7594 was assessed in terms of change from baseline in morning trough forced vital capacity (FVC) on Day 15 (defined as the average of the values at 23:00 and 23:30 hours after last dose of investigational medicinal product [IMP] on Day 14)|On Day 1 (pre-dose) and on Day 15 (pre-dose) in each period|All randomized participants who received at least one dose of randomized study drug, were included in the FAS, following the principle of ITT. Participants were included in the analysis according to the treatment to which they were randomized.||Liters||95% Confidence Interval|Least Squares Mean
637632|NCT02479412|Secondary|Efficacy of AZD7594 by Assessment of the Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) on Day 8|The efficacy of AZD7594 was assessed in terms of change from baseline in morning trough forced expiratory volume in 1 second (FEV1) on Day 8 (defined as the average of the values at 23:00 and 23:30 hours after last dose of investigational medicinal product [IMP] on Day 7)|On Day 1 (pre-dose) and on Day 8 (pre-dose) in each period|All randomized participants who received at least one dose of randomized study drug, were included in the FAS, following the principle of ITT. Participants were included in the analysis according to the treatment to which they were randomized.||Liters||95% Confidence Interval|Least Squares Mean
637633|NCT02479412|Secondary|Efficacy of AZD7594 by Assessment of the Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) on Day 15|The efficacy of AZD7594 was assessed in terms of change from baseline in fractional exhaled nitric oxide (FeNO) on Day 15|On Day 1 (pre-dose) and on Day 15 in each period|All randomized participants who received at least one dose of randomized study drug, were included in the FAS, following the principle of ITT. Participants were included in the analysis according to the treatment to which they were randomized.||Parts per billion (ppb)||95% Confidence Interval|Least Squares Mean
637634|NCT02479412|Secondary|Efficacy of AZD7594 by Assessment of the Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) on Day 8|The efficacy of AZD7594 was assessed in terms of change from baseline in fractional exhaled nitric oxide (FeNO) on Day 8|On Day 1 (pre-dose) and on Day 8 in each period|All randomized participants who received at least one dose of randomized study drug, were included in the FAS, following the principle of ITT. Participants were included in the analysis according to the treatment to which they were randomized.||Parts per billion (ppb)||95% Confidence Interval|Least Squares Mean
637635|NCT02479412|Primary|Efficacy of AZD7594 by Assessment of the Change From Baseline in Morning Trough Forced Expiratory Volume in 1 Second (FEV1) on Day 15|Comparison of the efficacy of AZD7594 in terms of change from baseline in morning trough forced expiratory volume in 1 second (FEV1) on Day 15 (defined as the average of the values at 23:00 and 23:30 hours after last dose of investigational medicinal product [IMP] on Day 14) with placebo|On Day 1 (pre-dose) and on Day 15 in each period|All randomized participants who received at least one dose of randomized study drug, were included in the full analysis set (FAS), following the principle of intent to treat (ITT). Participants were included in the analysis according to the treatment to which they were randomized.||Liters||95% Confidence Interval|Least Squares Mean
637636|NCT02479139|Secondary|Percentage of Participants With Gravimetric Sweat Production (GSP) Change From Baseline ≥ 50%|"GSP was measured using a pre-weighed filter paper placed into the axilla area (armpit) to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced.
The change from Baseline was calculated. The percentage of participants who had a change (reduction) from Baseline in GSP by ≥ 50% is reported."|Baseline, Weeks 4, 8, 12 and 18|mITT population was defined as all randomized participants who received at least 1 dose of investigational product with both a baseline value and ≥ 1 value during the double-blind treatment period. Missing values were imputed using the LOCF approach.||percentage of participants|||Number
637637|NCT02479139|Secondary|Percentage of Participants With Hyperhidrosis Disease Severity Scale (HDSS) Score Change From Baseline ≥ 2 Points|"The HDSS is a patient completed scale that measures how excessive sweating effects quality of life using a 4-point scale where: 1=My underarm sweating is not noticeable and never interferes with my daily activities to 4= My underarm sweating is intolerable and always interferes with my daily activities.
The change from Baseline was calculated. The percentage of participants who had a change (reduction) from Baseline in HDSS score by ≥ 2 points is reported."|Baseline, Weeks 4, 8, 12 and 18|mITT population was defined as all randomized participants who received at least 1 dose of investigational product with both a baseline value and ≥ 1 value during the double-blind treatment period. Missing values were imputed using the LOCF approach.||percentage of participants|||Number
637710|NCT02475031|Secondary|Secondary Endpoints Measured Will be Total Narcotic Usage at 60 Hours|All narcotic usage will be recorded at 1,12,24,36,48, and 60 hours. All narcotics will be converted to morphine equivalent for statistical calculation. These values reflect the total amount of narcotic used after combining all the data collected from each time point.|up to 60 hours|||mg||Standard Error|Mean
637711|NCT02475031|Primary|Total Narcotic Usage at 48 Hours|The primary endpoint of this study will be narcotic requirement at 48 hours|48 hours|||mg||Standard Error|Mean
637638|NCT02479139|Primary|Percentage of Participants With Both a Change From Baseline in Hyperhidrosis Disease Severity Scale (HDSS) Score by ≥ 2 Points and a Change From Baseline in Gravimetric Sweat Production (GSP) by ≥ 50%|"The HDSS is a patient completed scale that measures how excessive sweating effects quality of life using a 4-point scale where: 1=My underarm sweating is not noticeable and never interferes with my daily activities to 4= My underarm sweating is intolerable and always interferes with my daily activities.
GSP was measured using a pre-weighed filter paper placed into the axilla area (armpit) to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced.
The HDSS and the GSP were assessed at Baseline and Week 12. The change from Baseline was calculated. The percentage of participants who had both a change (reduction) from Baseline in HDSS score by ≥ 2 points and a change (reduction) from Baseline in GSP by ≥ 50% is reported."|Baseline, Week 12|Modified Intent-to-Treat (mITT) population was defined as all randomized participants who received at least 1 dose of investigational product with both a baseline value and ≥ 1 value during the double-blind treatment period. Missing values were imputed using the last observation carried forward (LOCF) approach.||percentage of participants|||Number
637639|NCT02478671|Secondary|Hand Perfusion as Measured by Pulse Oxymetry Waveform|pulse oxymetry waveform will be used to measure arterial perfusion|Subjects will be followed up to one week post procedure|||percent saturated||Full Range|Mean
637640|NCT02478671|Primary|MRI Based Radial Artery Measurement|Each subject's radial artery will be measured using MRI at varying levels of pressure within the TR Band.|Subjects will be followed up to one week post procedure|||millimeters||Full Range|Mean
637643|NCT02478372|Secondary|Total Number of Reported Participants With Complications and/or Adverse Events|The composite number of adverse events reported per group at 30 days and then one year post surgery|30 days and one year post-surgery|||participants|||Number
637644|NCT02478372|Secondary|Patient Reported Outcome Measure - Oxford Knee Score|Units measured on old Oxford Score (12-60) from a 12 point questionnaire. Where in 60 is poor and lower scores are better patient reported outcome scores|one week prior to surgery, 6 weeks post-surgery , one year post-surgery|||units on a scale||Full Range|Median
637645|NCT02478372|Secondary|Maximal Flexion Angle of the Operative Knee at Discharge From Rehabilitation||On day of discharge from rehabilitation in-patient care (average 96 hours post surgery)|||angle of flexion (degree)||Inter-Quartile Range|Median
637646|NCT02478372|Secondary|Day of Ambulation|Proportion of patients per day to ambulate for the first time with the physiotherapist > 3 Metres|theatre day, day 1 post-surgery, day two post-surgery|||percentage of patients|||Number
637647|NCT02478372|Secondary|Post-operative Nausea and Vomiting Scores|percentage of patients reporting either symptoms of nausea or vomiting over the first 72 hours following surgery. Scale 0-2 wherein 0=no nausea and vomiting, 1=nausea and 2= nausea and vomiting|24hours, 48 hours and 72 hours post-surgery|||percentage of patients reporting PONV|||Number
637648|NCT02478372|Secondary|Post-operative Urinary Catheterisation Rates|% of patients requiring catheterisation for urinary retention post-surgery|72 hours post-surgery|||percentage of patients catheterised|||Number
637649|NCT02478372|Secondary|Verbal Rating Score (VRS) Pain Scores|Summary 24 hour Verbal rated numerical pain scores were gathered each day. Scale range 0-10 where 0 is no pain and 10 is worst imaginable pain|24hours, 48 hours and 72 hours post-surgery|||units on a scale||Standard Deviation|Mean
637650|NCT02478372|Secondary|Average Post-operative Length of Stay|Participants will be followed for the duration of hospital stay, an expected average of 5 days|Average number of days spent in hospital follwoing surgery, an expected average of 5 days|||days||Inter-Quartile Range|Median
637651|NCT02478372|Primary|Proportion of Patients Discharged From Rehabilitation by Day Four|"% of patients meeting predetermined discharge criteria at 96 Hours post-surgery.
The discharge criteria were: self dependent (dress, personal care); in and out of bedd independently; up and down stairs; walk with crutches/stick; 80 degrees knee flexion; able to straight leg raise operated limb."|96 hours|Patients included following randomisation||percentage of patients|||Number
637652|NCT02477709|Primary|Effect of Gefapixant on BP|BP data will be summarized using descriptive statistics|6 hours|||units on a scale||Full Range|Mean
637653|NCT02477605|Secondary|Mean Post-operative Pain Rating at Day 1|The subject was asked to rate post-operative pain in the study eye using a score of 0-10, where 0=no pain and 10=the worst pain imaginable.|Day 1 post operative|Intent-to-Treat Analysis Set. Number Analyzed is the number of subjects with data.||units on a scale||Standard Deviation|Mean
637654|NCT02477605|Secondary|Mean Conjunctival Edema Score at Week 1|Conjunctival edema (swelling) was assessed during examination by the investigator and graded on a scale of 0-3, where 0=Absent and 3=Severe. Each sclerotomy wound was graded as infusion, vitrectomy probe, and illuminator and the average of the three was the overall Conjunctival Edema Score at the visit. Only one eye (study eye) contributed to the analysis.|Week 1 post operative|Intent-to-Treat Set. Number Analyzed is the number of subjects with data.||units on a scale||Standard Deviation|Mean
637655|NCT02477605|Primary|Mean Change in Intraocular Pressure (IOP) on Operative Day|IOP (fluid pressure inside the eye) was assessed using the study specified tono-pen and measured in millimeters of mercury (mmHg). Change was defined as the difference between immediate postoperative IOP and immediate preoperative IOP. A greater change in IOP may indicate a less stable posterior chamber and/or a more invasive surgery.|Day 0 preoperative, Day 0 postoperative|Intent-to-Treat Analysis Set. Number Analyzed is the number of subjects with data.||mmHG||Standard Deviation|Mean
637656|NCT02477527|Other Pre-specified|Safety as Measured by Side Effects|Monitor for any side effects that are spontaneously reported by subjects and reported on questionnaires.|24 weeks|no adverse effects reported.||Participants|||Count of Participants
637712|NCT02474498|Secondary|Relative Gingival Margin Position (RGMP) at 12 Months||12 months|||mm||Standard Deviation|Mean
637713|NCT02474498|Secondary|Periodontal Probing Depth at 12 Months||12 months|||mm||Standard Deviation|Mean
638047|NCT02454127|Secondary|C-reactive Protein|Change from baseline high-sensitivity CRP at 1 year, measured in mg/L|1 year|Intent-to-treat analysis. Missing data were replaced with baseline values.||mg/L||Standard Deviation|Mean
637657|NCT02477527|Secondary|Improvements in Sleep Disorder Score|Changes in quality of sleep at week 24 as measured by Pittsburgh Sleep Quality Index (PSQI). The Pittsburgh Sleep Quality Index (PSQI) is used to measure the quality and patterns of sleep in adults. It rates sleep based on seven domains: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction over the last month. It is a self-administered questionnaire covering these seven areas of sleep. Scoring of the answers is based on a 0 to 3 scale, whereby 3 reflects the negative extreme on the Likert Scale. The scores for the 7 items ranged from 0(none) - 3(severe), and the total score is 0-21. The reported values in the table represent the change in the overall scores on the PSQI scale. The values were added and reported as the sum of the individual measures. A negative score correlates with improvement of the sleep quality.|24 weeks|||units on a scale||Full Range|Mean
637658|NCT02477527|Secondary|Improvements in Central Nervous System Toxicity Score|"Changes in Central Nervous System toxicity score at week 24 as measured by SSAT 047 scale.
The scale is a questionnaire that participants complete at each visit. The SSAT 047 scores 10 items related to efavirenz side effects including: dizziness, depression, insomnia, anxiety, confusion, impaired concentration, headache, somnolence, aggressive mood and abnormal dreams. The side effects were scored as 0 for “None”, 1 for “Mild”, 2 for “Moderate” and 3 for “Severe”. The scores for the 10 items ranged from 0(none) - 3(severe), and the total score is 0-30. The scores are then averaged to determine the overall impact on central nervous system symptoms and reported as the sum of the measures."|24 weeks|||units on a scale||Full Range|Mean
637659|NCT02477527|Secondary|T-cell Changes|Change in CD4 Cell count from baseline to 24 weeks.|24 weeks|Participants completing the study.||cells / cc||Full Range|Mean
637660|NCT02477527|Primary|Percentage of Patients With Viral Loads < 50 Following the Switch|percentage of patients with viral loads < 50 following the switch at 24 weeks.|24 weeks|Participants completing the study.||Participants|||Count of Participants
637661|NCT02477020|Secondary|Change From Baseline in the University of California San Diego Performance-based Skills Assessment – Brief Version (UPSA-B) at Week 3 and 6|The UPSA-B evaluates the abilities of individuals to perform everyday tasks that are considered necessary for independent functioning in the community. The UPSA-B uses role playing situations to evaluate skills in 5 areas: household chores, communication, finance, transportation, and planning recreational activities. Subscale scores range from 0 to 20 points, and total scores range from 0 to 100 points; higher scores reflect better performance. Least square mean and standard error values were determined using a MMRM. A positive change from Baseline indicates improvement.|Baseline, Weeks 3 and 6|The full analysis set included all participants who were randomized, received at least one dose of study drug and have a baseline value and at least one valid postbaseline value for assessment of primary efficacy. Here ‘n’ refers to number of participants analyzed at each time point.||score on a scale||Standard Error|Least Squares Mean
637662|NCT02477020|Secondary|Change From Baseline in the Personal and Social Performance (PSP) Scale Score at Weeks 3 and 6|The PSP scale is a clinician-reported outcome instrument that was developed to evaluate social and personal functioning. It measures 4 domains of social functioning: socially useful activities including work and study, personal and social relationships, self-care and disturbing and aggressive behaviors. The clinician assigns an initial 6-degree of severity to each area (absent, mild, manifest, marked, severe or very severe). The final result is a single assessment of social functioning ranging from 0 (no autonomy) to 100 (excellent functioning). Least square mean and standard error values were determined using a MMRM. A positive change from Baseline indicates improvement.|Baseline, Weeks 3 and 6|The full analysis set included all participants who were randomized, received at least one dose of study drug and have a baseline value and at least one valid postbaseline value for assessment of primary efficacy. Here ‘n’ refers to number of participants analyzed at each time point.||score on a scale||Standard Error|Least Squares Mean
637663|NCT02477020|Secondary|Change From Baseline in Brief Negative Symptom Scale (BNSS) Score at Weeks 3 and 6|The BNSS is a13-item instrument designed for use in clinical trials and other studies that measures 5 domains of negative symptoms: blunted affect, alogia, asociality, anhedonia, and avolition. All the items in the BNSS are rated on a 7-point (0–6) scale, with anchor points generally ranging from the symptom’s being absent (0) to severe (6). A scale total score is calculated by summing the 13 individual items; total score range of 0 to 78, where higher score indicates higher severity of negative symptoms. Least square mean and standard error values were determined using a MMRM. A negative change from Baseline indicates improvement.|Baseline, Weeks 3 and 6|The full analysis set included all participants who were randomized, received at least one dose of study drug and have a baseline value and at least one valid postbaseline value for assessment of primary efficacy. Here ‘n’ refers to number of participants analyzed at each time point.||score on a scale||Standard Error|Least Squares Mean
637664|NCT02477020|Secondary|Change From Baseline in Brief Assessment of Cognition in Schizophrenia (BACS) Score at Weeks 3 and 6|BACS is specifically designed to measure treatment- related improvements in cognition and includes alternate forms. The battery of tests in the BACS includes brief assessments of reasoning and problem solving, verbal fluency, attention, verbal memory, working memory, and motor speed. The primary measure from each test of the BACS is standardized by creating z-scores whereby the mean of the test session of a healthy participant is set to 0 and the standard deviation set to 1. A composite score was calculated by averaging all of the 6 standardized primary measures from the BACS, and then calculating a z-score of the composite. The composite z-score indicates how much higher or lower the participant’s cognition is compared to a healthy person. Least square mean and standard error values were determined using a MMRM.|Baseline, Weeks 3 and 6|The full analysis set included all participants who were randomized, received at least one dose of study drug and have a baseline value and at least one valid postbaseline value for assessment of primary efficacy. Here ‘n’ refers to number of participants analyzed at each time point.||z-score||Standard Error|Least Squares Mean
637695|NCT02475564|Primary|Pain Scores Measured by VAS (Visual Analog Scale) at Day 42.|Pain will be measured by VAS (visual analog scale) as baseline and at the end of the study, considering the last 7 days. VAS was used to measuring pain intensity, ranging continuously from 0 (no pain) to 10 (worst imaginable pain). The main outcome compared median pain levels between both arms on day 42.|42 days|Intention to treat analysis, patients who were lost on follow-up had their last registry on pain values or plasma levels measurements repeated in the following consultations.||units on a scale||Full Range|Median
647808|NCT02117193|Primary|Neuromuscular Performance|knee extensor isometric torque|After each sequence, up to 8 hours|||Nm||Standard Deviation|Mean
637665|NCT02477020|Secondary|Percentage of Responders Based on CGI-I Ratings Score|Responder based on CGI-I is defined as a rating of much improved or very much improved. The CGI-I assesses the participant’s improvement (or worsening). The clinician is required to assess the participant’s condition relative to baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.|Weeks 1, 2, 3, 4, 5 and 6|The full analysis set included all participants who were randomized, received at least one dose of study drug and have a baseline value and at least one valid postbaseline value for assessment of primary efficacy. Here ‘n’ refers to number of participants analyzed at each time point.||percentage of participants|||Number
637666|NCT02477020|Secondary|Clinical Global Impression Scale – Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 5 and 6|The CGI-I assesses the participant’s improvement (or worsening). The clinician is required to assess the participant’s condition relative to baseline on a 7-point scale. CGI-I scale assesses the participant's improvement (or worsening) on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. Least square mean and standard error values were calculated using a MMRM.|Weeks 1, 2, 3, 4, 5 and 6|The full analysis set included all participants who were randomized, received at least one dose of study drug and have a baseline value and at least one valid postbaseline value for assessment of primary efficacy. Here ‘n’ refers to number of participants analyzed at each time point.||score on a scale||Standard Error|Least Squares Mean
637667|NCT02477020|Secondary|Change From Baseline in Clinical Global Impression – Severity (CGI-S) Score at Weeks 1, 2, 3, 4, 5,and 6|The CGI-S is a clinician rated scale designed to assess global severity of illness. CGI-S is a 7-point scale that requires the clinician to rate the severity of the participant's illness at the time of assessment. A participant is assessed on severity of mental illness on the following scale: 1, normal, not at all ill; 2, borderline ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. Least square mean and standard error values were determined using a MMRM. A negative change from Baseline indicates improvement.|Baseline, Weeks 1, 2, 3, 4, 5 and 6|The full analysis set included all participants who were randomized, received at least one dose of study drug and have a baseline value and at least one valid postbaseline value for assessment of primary efficacy. Here ‘n’ refers to number of participants analyzed at each time point.||score on a scale||Standard Error|Least Squares Mean
637668|NCT02477020|Secondary|Percentage of Clinical Responders Based on the PANSS Total Score|Clinical responders based on the PANSS total score is defined as at least 30% improvement from baseline in the total score. PANSS assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210; higher score indicates greater severity.|Weeks 1, 2, 3, 4, 5 and 6|The full analysis set included all participants who were randomized, received at least one dose of study drug and have a baseline value and at least one valid postbaseline value for assessment of primary efficacy. Here ‘n’ refers to number of participants analyzed at each time point.||percentage of participants|||Number
637669|NCT02477020|Secondary|Change From Baseline in PANSS Subscales at Weeks 1, 2, 3, 4, 5 and 6|PANSS assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Positive subscale consists of 7 items which assesses the positive symptoms with subscale score ranging from 7 to 49, where higher score indicates greater severity. Negative subscale consists of 7 items which assesses the negative symptoms with subscale score ranging from 7 to 49, where higher score indicates greater severity. General psychopathology subscale consists of 16 items which assesses the general symptoms of schizophrenia with subscale score ranging from 16 to 96, where higher score indicates greater severity. Least square mean and standard error values were determined using a MMRM. A negative change from Baseline indicates improvement.|Baseline and Weeks 1, 2, 3, 4, 5 and 6|The full analysis set included all participants who were randomized, received at least one dose of study drug and have a baseline value and at least one valid postbaseline value for assessment of primary efficacy. Here ‘n’ refers to number of participants analyzed at each time point.||score on a scale||Standard Error|Least Squares Mean
637670|NCT02477020|Secondary|Change From Baseline in PANSS Subscales Using the Marder 5-factor Model at Weeks 1, 2, 3, 4, 5, and 6|PANSS subscales using the Marder 5-factor model include positive symptoms (8-items, total score = total score = 8 to 56, with a higher score indicating greater severity of symptoms), negative symptoms (7-items, total score = 7 to 49, with a higher score indicating greater severity of symptoms), disorganized thoughts (7-items, total score = 7 to 49, with a higher score indicating greater severity of symptoms), impulsivity/hostility (4-items, total score = 4 to 28, with a higher score indicating greater severity of symptoms), anxiety/depression (4-items, total score = 4 to 28, with a higher score indicating greater severity of symptoms). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Weeks 1, 2, 3, 4, 5 and 6|The full analysis set included all participants who were randomized, received at least one dose of study drug and have a baseline value and at least one valid postbaseline value for assessment of primary efficacy. Here ‘n’ refers to number of participants analyzed at each time point.||score on a scale||Standard Error|Least Squares Mean
637671|NCT02477020|Secondary|Change From Baseline in PANSS Total Score at Weeks 1, 2, 3, 4 and 5|PANSS assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210; higher score indicates greater severity. Least square mean and standard error values were determined using a MMRM. A negative change from Baseline indicates improvement.|Baseline and Weeks 1, 2, 3, 4 and 5|The full analysis set included all participants who were randomized, received at least one dose of study drug and have a baseline value and at least one valid postbaseline value for assessment of primary efficacy. Here ‘n’ refers to number of participants analyzed at each time point.||score on a scale||Standard Error|Least Squares Mean
638048|NCT02454127|Secondary|Insulin|Change from baseline insulin at 1 year, measured in microIU/mL|1 year|Intent-to-treat analysis. Missing data were replaced with baseline values||microIU/ml||Standard Deviation|Mean
637672|NCT02477020|Primary|Change From Baseline in the Positive and Negative Symptom Scale (PANSS) Total Score at Week 6|PANSS assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210; higher score indicates greater severity. Least square mean and standard error values were determined using a mixed model for repeated measures (MMRM). A negative change from Baseline indicates improvement.|Baseline and Week 6|The full analysis set included all participants who were randomized, received at least one dose of study drug and have a baseline value and at least one valid postbaseline value for assessment of primary efficacy. Here number of participants analyzed are participants evaluable for this outcome measure.||score on a scale||Standard Error|Least Squares Mean
637673|NCT02476617|Primary|Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12|The changes from week 0 to post-treatment (PT) week 12 in key ISG expression in PBMCs for participants achieving sustained virologic response 12 weeks PT (SVR12) where SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (<LLOQ) 12 weeks after the last dose of study drug. For each key ISG, fold change was defined as the ratio of the difference between PT Week 12 and baseline expressions over the baseline expression.|Week 0 to Post-Treatment Week 12|All participants who achieved SVR12 and had both baseline and post-baseline value at Post-Treatment Week 12 were included in this analyses..||Fold change||Standard Deviation|Mean
637674|NCT02476422|Secondary|Number of Patients With Any Adverse Events, Serious Adverse Events and Death|Treatment emergent adverse events are reported in the below data table.|time of dosage administration up to the follow-up phone call on study Day 3 (maximum 3 days)|Safety analyses were performed on the safety set, which included all randomized subjects who were exposed to study drug.||Participants|||Number
637675|NCT02476422|Secondary|Number of Patients With Different Responses Based on Patient’s Global Assessment of Response to Treatment (PGART)|PGART was measured by asking patients to give a score on a scale from 0 to 4, where 0 = poor; 1 = fair; 2 = good; 3 = very good; 4 = excellent. This measurement was taken at the end of 8 hours, or before the use of rescue medication (for a patient who takes rescue medciation within the 8 hour period).|At 8 hour postdose prior to use of rescue medication|The efficacy analyses were performed on the full analysis set (FAS), which consisted of all randomized subjects who were exposed to study drug and provided at least 1 postdose assessment on any efficacy parameter.||Participants|||Number
637676|NCT02476422|Secondary|Number of Patients Needing Rescue Medication|The number of patients needing rescue medication within the 8 hour treatment period was evaluated.|From dose administration to 8 hours post dose|The efficacy analyses were performed on the full analysis set (FAS), which consisted of all randomized subjects who were exposed to study drug and provided at least 1 post-dose assessment on any efficacy parameter.||Participants|||Number
637677|NCT02476422|Secondary|Duration of Analgesia|Duration of analgesia (time to first use of rescue medication) was evaluated, from dose administration to the time of first use of rescue medication within the 8-hour treatment period. Censored observations were included in calculating this endpoint. Censored subjects include any subject who did not take rescue medication prior to the end of the assessment period of 480 minutes (8 hours).|From dose administration to 8 hours post dose|The efficacy analyses were performed on the full analysis set (FAS), which consisted of all randomized subjects who were exposed to study drug and provided at least 1 post-dose assessment on any efficacy parameter.||minutes||Inter-Quartile Range|Median
637678|NCT02476422|Secondary|Peak Analgesic Effect|"Peak analgesic relief is represented through highest pain intensity difference (PID), highest VASPI reduction, and highest pain relief scores. Pain intensity was measured on a verbal rating scale (VRS) ranging from 0 to 3 (none to severe, with higher score for higher pain intensity). PID represents difference in this score at baseline and specific time points, larger change indicating larger reduction in pain, with highest PID representing the largest difference. Pain relief was recorded on a scale ranging from 0 to 4 (none to complete, with higher score for higher pain relief), with highest pain relief representing maximum relief obtained. Pain intensity was also measured through a 100 mm visual analogue scale (VASPI), ranging from no pain (0 mm) to worst possible pain (100 mm). A positive change in VASPI indicates reduction in pain, with highest VASPI reduction representing highest change."|From dose administration to 8 hours post dose|The efficacy analyses were performed on the full analysis set (FAS), which consisted of all randomized subjects who were exposed to study drug and provided at least 1 post-dose assessment on any efficacy parameter. Last observation carried forward (LOCF) was used as the imputation technique.||units on a scale||Standard Deviation|Mean
637679|NCT02476422|Secondary|Summed Total Pain Relief (TOTPAR) at Different Time Points|"After the administration of the single dose of the assigned study treatment, at the defined study time points, the clinical site staff captured pain relief information from each subject.
The subject was asked “What is the amount of pain relief as compared to the starting pain?” and the response was recorded as 0 = none, 1 = a little, 2 = some, 3 = a lot, or 4 = complete.
Total pain relief (TOTPAR) was the weighted sum of the pain relief scores from the 15-minute to the 8-hour observation points (TOTPAR8). Additionally, TOTPARs at 1, 2, 4 and 6 hours were calculated. The weights used for these values (evaluation time points) were 0.25 for the 15-, 30-, 45-, and 60-minute observations, 0.5 for the 90-minute, 2- and 4-hour observations, and 1 for the remaining observations."|1, 2, 4, 6, and 8 hours postdose|The efficacy analyses were performed on the full analysis set (FAS), which consisted of all randomized subjects who were exposed to study drug and provided at least 1 postdose assessment on any efficacy parameter. Last observation carried forward (LOCF) was used as the imputation technique.||units on a scale||Standard Error|Least Squares Mean
641939|NCT02288273|Secondary|Change From Baseline (Day -1) to Day 64 and Day 22 in 2- Hour Mean Weighted PPG (After the Breakfast Meal)||Day 22 and Day 64|||mg/dL||Standard Error|Least Squares Mean
637680|NCT02476422|Secondary|Sum of Pain Intensity Difference (SPID)|"At baseline and at each defined study time point, the clinical site staff captured pain intensity information from each subject using the 4-point categorical VRS. The subject was asked
“What is your pain level at this time?” and the response was recorded as 0 = none, 1 = mild, 2 = moderate, and 3 = severe. Pain intensity difference (PID) was the difference between the baseline pain intensity score and the pain intensity score at a specific observation point. SPID is the weighted sum of PIDs from the 15-minute to the 8-hour observation point (SPID8). Additionally, SPID evaluations were also be done at 1 (SPID1), 2 (SPID2), 4 (SPID4) and 6 (SPID6) hours post dose. The weights used for these values were 0.25 for the 15-, 30-, 45-, and 60-minute observations, and 0.5 for the 90-minute, 2- and 4-hour observations, and 1 for the remaining observations."|1, 2, 4, 6, and 8 hours postdose|The efficacy analyses were performed on the full analysis set (FAS), which consisted of all randomized subjects who were exposed to study drug and provided at least 1 postdose assessment on any efficacy parameter. Last observation carried forward (LOCF) was used as the imputation technique.||units on a scale||Standard Error|Least Squares Mean
637681|NCT02476422|Secondary|Time to Onset of First Perceptible Pain Relief (FPR)|Using the double stopwatch technique, participant started two stopwatches at dosing, and stopped the first stopwatch as soon as he/she first began to feel 'any' relief from pain. The time elapsed was recorded as the FPR.|Within 8 hours postdose|The efficacy analyses were performed on the full analysis set (FAS), which consisted of all randomized subjects who were exposed to study drug and provided at least 1 post-dose assessment on any efficacy parameter.||minutes||Inter-Quartile Range|Median
637682|NCT02476422|Secondary|Time to Onset of Meaningful Pain Relief (MPR)|Using the double stopwatch technique, participant started two stopwatches at dosing, and stopped the second stopwatch as soon as he/she began to experience 'meaningful' relief from pain. Time elapsed is recorded as the MPR.|Within 8 hours postdose|The efficacy analyses were performed on the full analysis set (FAS), which consisted of all randomized subjects who were exposed to study drug and provided at least 1 postdose assessment on any efficacy parameter.||minutes||Inter-Quartile Range|Median
637683|NCT02476422|Secondary|Time to Confirmed First Perceptible Pain Relief|Time to onset of first perceptible pain relief (FPR), provided the FPR was subsequently 'confirmed' through the achievement of meaningful pain relief (MPR). Participant started two stopwatches at dosing, and recorded FPR by stopping the first stopwatch when he/she first experienced 'any' pain relief. FPR is ‘confirmed’ only if the participant also stopped the second stopwatch indicating ‘meaningful pain relief’.|Within 8 hours postdose|The efficacy analyses were performed on the full analysis set (FAS), which consisted of all randomized subjects who were exposed to study drug and provided at least 1 postdose assessment on any efficacy parameter.||minutes||Inter-Quartile Range|Median
637684|NCT02476422|Secondary|Area Under the Curve (AUC) of Visual Analog Scale of Pain Intensity (VASPI) Measuring Change From Baseline at Different Time Points|"VASPI reduction from baseline is the difference between the Baseline VASPI score and the VASPI score at a specific observation point. Subjects were asked to identify their pain intensity using the 100 mm VASPI to indicate their current level of pain intensity on the 100 mm VASPI labeled “no pain” (0 mm) as the left anchor and
“worst possible pain” (100 mm) as the right anchor. A positive change shows reduction in pain.
AUC of VASPI reduction from baseline for each time point was calculated using the trapezoidal rule."|15, 30, 45, 60 and 90 minutes, and 2, 4, 5, 6, 7, and 8 hours post dose|The efficacy analyses were performed on the full analysis set (FAS), which consisted of all randomized subjects who were exposed to study drug and provided at least 1 post-dose assessment on any efficacy parameter. Last observation carried forward (LOCF) was used as the imputation technique.||units on a scale*hours||Standard Error|Least Squares Mean
637685|NCT02476422|Secondary|Change From Baseline in Visual Analog Scale of Pain Intensity (VASPI) at Different Time Points|"VASPI reduction from baseline is the difference between the Baseline VASPI score and the VASPI score at a specific observation point. Subjects were asked to identify their current level of pain intensity on the 100 mm VASPI, labeled no pain (0 mm) as the left anchor and worst possible pain (100 mm) as the right anchor. A positive change represents a reduction in pain."|15, 30, 45, and 90 minutes, and 2, 4, 5, 6, 7, and 8 hours post dose|The efficacy analyses were performed on the full analysis set (FAS), which consisted of all randomized subjects who were exposed to study drug and provided at least 1 post-dose assessment on any efficacy parameter. Last observation carried forward (LOCF) was used as the imputation technique.||Units on a scale||Standard Error|Least Squares Mean
637686|NCT02476422|Primary|Change From Baseline in Visual Analog Scale of Pain Intensity (VASPI) at 60 Minutes Post Dose|"VASPI reduction from baseline is the difference between the Baseline VASPI score and the VASPI score at a specific observation point. Subjects were asked to identify their current level of pain intensity on the 100 mm VASPI, labeled no pain (0 mm) as the left anchor and worst possible pain (100 mm) as the right anchor. A positive change represents a reduction in pain."|60 minutes postdose|The efficacy analyses were performed on the full analysis set (FAS) which consisted of all randomized subjects who were exposed to study drug and provided at least 1 post-dose assessment on any efficacy parameter. Last observation carried forward (LOCF) was used as the imputation technique.||units on a scale||Standard Error|Least Squares Mean
637687|NCT02475980|Secondary|Follow-up Adherence|Proportion of girls who present for follow-up appointment after referral to Adolescent Gynecology outpatient clinic|4 weeks after enrollment|Number of participants given a referral to Adolescent Gynecology in PED||participants|||Number
637688|NCT02475980|Secondary|Descriptive Statistics of Participants|Frequencies and descriptive statistics of participant demographics, comorbidities associated with unintended adolescent pregnancy, and contraceptive use|At conclusion of study data collection, approximately 8 weeks after enrollment|Participants consented for project||participants|||Number
637689|NCT02475980|Primary|Contraceptive Initiation|Proportion of participants who report initiating contraception or changing to a more effective method of contraception|4 weeks after enrollment|Of the 13 girls consented to the study, 1 initiated a new contraception method following the intervention.||participants|||Number
637690|NCT02475980|Primary|Participant Satisfaction|Participant ratings of acceptability of contraceptive counseling in the emergency department and satisfaction with counseling|4 weeks after enrollment|Number of girls available for follow-up at 4-week phone call.||participants|||Number
637691|NCT02475980|Primary|Proportion of Eligible Girls Offered Counseling Intervention|Proportion of girls eligible to participate in study who were offered contraceptive counseling|Approximately 4 weeks after enrollment|||participants|||Number
637699|NCT02475278|Primary|Number of Participants With Serum Samples Obtained on Day 29 for Assessment of Seropositivity for Both Anti-NoV GI.1 VLP and GII.4 VLP Antibodies|Serum samples were obtained to establish proficiency panels for the pan-Ig ELISA and the HBGA binding assay. The number of participants with assessments for both the GI.1 VLP and GII.4 VLP antibodies and by both the pan-Ig ELISA and the HBGA binding assay, and with values available at Baseline and Day 29 are reported.|Day 29|Safety Analysis Set, all participants who received the trial vaccine (NoV Vaccine).||participants|||Number
637700|NCT02475278|Secondary|Percentage of Participants Experiencing Serious Adverse Events|A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.|Day 1 up to Day 183|Safety Analysis Set, all participants who received the trial vaccine (NoV Vaccine).||percentage of participants|||Number
637701|NCT02475278|Secondary|Percentage of Participants With Unsolicited Adverse Events (AEs) by Maximum Severity|An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. Unsolicited AEs are any AEs that are not solicited local or systemic AEs, as defined by this study. Unsolicited AEs are presented as the percentage of participants experiencing at least one AE, overall and by severity, using the participant’s worst reported severity grade. Only categories for which there was at least 1 participant are reported.|Days 1 through 28|Safety Analysis Set, all participants who received the trial vaccine (NoV Vaccine).||percentage of participants|||Number
637702|NCT02475278|Secondary|Percentage of Participants With Elevated Daily Oral Temperature|Safety assessment included measurement of body temperature for 7 days following vaccination (including the day of vaccination) by using diary cards. Participants recorded the highest body temperature observed each day in a daily diary. The highest body temperature measurement per participant across Day 1 to Day 7 was categorized as fever present (≥100.4ºF, ≥38ºC) or fever absent (<100.4ºF, <38ºC).|Days 1 to 7 days after vaccination|Safety Analysis Set, all participants who received the trial vaccine (NoV Vaccine).||percentage of participants|||Number
637703|NCT02475278|Secondary|Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Maximum Severity|Safety assessment included collection of solicited systemic AEs for 7 days following vaccination (including the day of vaccination) by using diary cards. Solicited systemic AEs are defined as headache, fatigue, myalgia, arthralgia, vomiting and diarrhea and are summarized as either none or any, where ‘any’ will be broken down into the following severity categories: mild, moderate, severe. Solicited systemic AEs are presented as the percentage of participants experiencing a solicited systemic AE, by AE, overall and by severity, using the participant’s worst reported severity grade. Only categories for which there was at least 1 participant are reported.|Days 1 through 7|Safety Analysis Set, all participants who received the trial vaccine (NoV Vaccine).||percentage of participants|||Number
637704|NCT02475278|Secondary|Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Maximum Severity|Safety assessment included collection of solicited local AEs for 7 days following vaccination (including the day of vaccination) by using diary cards. Solicited local injection site AEs are defined as pain, erythema (redness), induration and swelling. Pain is summarized as either none or any, where ‘any’ will be broken down into the following severity categories: mild, moderate, severe. Erythema, swelling and induration are recorded as yes or no, where the definition of ‘yes’ is any area ≥2.5 cm; and ‘yes’ is further broken down into the following severity categories: ≥2.5 cm - ≤5.0 cm (mild intensity), >5.0 cm - ≤ 10.0 cm (moderate intensity), >10.0 cm severe intensity). Injection site AEs are presented as the percentage of participants experiencing a reaction, by reaction type, overall and by severity, using the participant’s worst reported severity grade. Only categories for which there was at least 1 participant are reported.|Days 1 through 7|Safety Analysis Set, all participants who received the trial vaccine (NoV Vaccine).||percentage of participants|||Number
637705|NCT02475278|Primary|Number of Participants With Serum Samples Obtained on Day 15 for Assessment of Seropositivity for Both Anti-NoV GI.1 VLP and GII.4 VLP Antibodies|Serum samples were obtained to establish proficiency panels for the pan-Ig ELISA and the HBGA binding assay. The number of participants with assessments for both the GI.1 VLP and GII.4 VLP antibodies and by both the pan-Ig ELISA and the HBGA binding assay, and with values available at Baseline and Day 15 are reported.|Day 15|Safety Analysis Set, all participants who received the trial vaccine (NoV Vaccine).||participants|||Number
637706|NCT02475278|Primary|Number of Participants With Serum Samples Obtained on Day 8 for Assessment of Seropositivity for Both Anti-NoV GI.1 VLP and GII.4 VLP Antibodies|Serum samples were obtained for assay validation of the pan-Ig enzyme-linked immuno-sorbent assay (ELISA) and the histoblood group antigen (HBGA) binding assay. The number of participants with assessments for both the GI.1 VLP and GII.4 VLP antibodies and by both the pan-Ig ELISA and the HBGA binding assay, and with values available at Baseline and Day 8 are reported.|Day 8|Safety Analysis Set, all participants who received the trial vaccine (NoV Vaccine).||participants|||Number
637707|NCT02475031|Secondary|Sedation Scores at 48 Hours|Post-operative sedation scores will be recorded at 48 hours. Range of score is 0-3. 0=Awake and Alert, 1=Quietly Awake, 2=Asleep and Arousable, 3=Deep sleep.|48 hours|||units on a scale||Standard Error|Mean
641940|NCT02288273|Secondary|Change From Baseline (Day1) to Day 70 and Day 22 in FPG||Day 22/Day70|||mg/dL||Standard Error|Least Squares Mean
637714|NCT02474498|Secondary|Relative Vertical Clinical Attachment Level (RVCAL) at 12 Months|The relative vertical clinical attachment level (RVCAL) will be measured with the same type of probe (PCP-15 Periodontal Probe - Hu-Friedy - Chicago, IL, USA) as the distance between the deepest point reached by the probe when introduced vertically into the buccal periodontal pocket. This parameter will be evaluated at one specific site at the buccal furcation entrance, determined by a groove made on an individually manufactured acrylic stent and recorded to the nearest 0.5mm.|12 months|||mm||Standard Deviation|Mean
637715|NCT02474498|Primary|Relative Horizontal Clinical Attachment Level (RHCAL) at 12 Months|The relative horizontal clinical attachment level (RHCAL) will be measured with the same type of probe (PCP-15 Periodontal Probe - Hu-Friedy - Chicago, IL, USA) as the distance between the deepest point reached by the probe when introduced horizontally into the furcation and the lower border of the stent. This parameter will be evaluated at one specific site at the buccal furcation entrance, determined by a groove made on an individually manufactured acrylic stent and recorded to the nearest 0.5mm.|12 months|||mm||Standard Deviation|Mean
637716|NCT02473991|Primary|Placental Thickness at 3rd Trimester||30-34 weeks of pregnancy|||millimeter||Standard Deviation|Mean
637717|NCT02473991|Primary|Placental Thickness in Second Trimester|placental thickness measured in millimeter|15-20 weeks of gestation|||millimeter||Standard Deviation|Mean
637718|NCT02473991|Primary|Fetal Weight (Fetal Weight at Birth)|Fetal weight (fetal weight at birth) (in grams)|9 months|||gram||Standard Deviation|Mean
637719|NCT02473523|Other Pre-specified|Median Change in Verbal Numeric Pain Scale|Summary statistics of mean ± standard error will be provided. Longitudinal change for the numeric pain scale across the yoga session will be reported.|Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)||||||
637720|NCT02473523|Other Pre-specified|Mean Change in Verbal Numeric Pain Scale|Summary statistics of mean ± standard error will be provided. Longitudinal change for the numeric pain scale across the yoga session will be reported.|Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)||||||
637721|NCT02473523|Other Pre-specified|Median Change in Balance|Median (range) on the Bruininks-Oseretsky Test of Motor Proficiency will be provided.|Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)||||||
637722|NCT02473523|Other Pre-specified|Mean Change in Balance|Mean ± standard error on the Bruininks-Oseretsky Test of Motor Proficiency will be provided.|Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)||||||
637723|NCT02473523|Other Pre-specified|Median Change in Hamstring Flexibility|Hamstring flexibility will be assessed by the Sit and Reach Test. Median (range) will be provided.|Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)||||||
637724|NCT02473523|Other Pre-specified|Mean Change in Hamstring Flexibility|Hamstring flexibility will be assessed by the Sit and Reach Test. Mean ± standard error will be provided.|Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)||||||
637725|NCT02473523|Other Pre-specified|Median Change in Grip Strength|"A calibrated Jamar hydraulic hand dynamometer will be used to measure grip strength. Median (range) will be provided."|Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)||||||
637726|NCT02473523|Other Pre-specified|Mean Change in Grip Strength|"A calibrated Jamar hydraulic hand dynamometer will be used to measure grip strength. Mean ± standard error will be provided."|Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)||||||
637727|NCT02473523|Other Pre-specified|Median Change in Quadriceps Strength|"The Biodex System 3 Dynamometer will be utilized to measure isometric quadriceps muscle contractions. Median (range) will be provided."|Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)||||||
637728|NCT02473523|Other Pre-specified|Mean Change in Quadriceps Strength|"The Biodex System 3 Dynamometer will be utilized to measure isometric quadriceps muscle contractions. Mean ± standard error will be provided."|Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)||||||
637729|NCT02473523|Other Pre-specified|Median Change in PedsQL Multidimensional Fatigue Scale|Median (range) will be provided.|Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)||||||
637730|NCT02473523|Other Pre-specified|Mean Change in PedsQL Multidimensional Fatigue Scale|Mean ± standard error will be provided.|Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)||||||
637731|NCT02473523|Other Pre-specified|Median Change in PedsQL Cancer Module Score|Median (range) will be provided.|Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)||||||
637732|NCT02473523|Other Pre-specified|Mean Change in PedsQL Cancer Module Score|Mean ± standard error will be provided.|Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)||||||
637733|NCT02473523|Primary|Rate of Patients Who Complete the Study|The rate of enrolled and consented patients who complete the 60-minute yoga sessions offered over a 4-6 week period to the total number of participants on the study. It is hypothesized that 60% of those participants will complete the intervention. Thus, if more than 5 patients can not complete the intervention, then it will be concluded that the trial is not feasible.|At end of 4-6 weeks||||||
637734|NCT02473523|Primary|Rate of Patients Who Are Willing to Participate|The rate of participants who are willing to participate on this protocol to the total number of participants approached. It is anticipated that 50% approached patients will agree to participate on the study. Twenty five patients will be approached and asked to participate in the study. If more than 6 patients out of 25 approached patients refuse to participate in the study, the study will be closed, and it will be concluded that the trial is not feasible.|Day 0||||||
637735|NCT02473510|Secondary|Percentage of Participants Who Require Antipyretic and/or Analgesic Medication|Percentage of participants who require antipyretic and/or analgesic medication were reported.|Baseline (Day 1) up to Day 8 and Day 15|The ITT population included all participants that were randomized and treated with investigational product.||Percentage of Participants|||Number
637745|NCT02472886|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as
On-treatment virologic failure
confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ, while on treatment (ie, breakthrough),
confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment (ie, rebound), HCV RNA persistently ≥ LLOQ through 8 weeks of treatment (ie, nonresponse)
Relapse
HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement"|Up to Posttreatment Week 24|Full Analysis Set||percentage of participants|||Number
637736|NCT02473510|Secondary|Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) and New Onset Chronic Disease (NOCDs)|An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent SAEs were serious events between administration of study drug and up to 181 days after the dose that are absent before treatment or that worsen relative to pretreatment state. An NOCD is a newly diagnosed medical condition that is of a chronic, ongoing nature and is assessed by the investigator as medically significant. Results were given for TESAEs and NOCDs reported within 29 days and 181 days after vaccination.|Baseline (Day 1) up to Day 29 and 181|The ITT population included all participants that were randomized and treated with investigational product.||Participants|||Number
637737|NCT02473510|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs)|An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs were events between administration of study drug and up to 15 days after vaccination that are absent before treatment or that worsened relative to pre-treatment state. Results were given for AEs reported within 8 days and 15 days after vaccination.|Baseline (Day 1) up to Day 8 and Day 15|The ITT population included all participants that were randomized and treated with investigational product.||Participants|||Number
637738|NCT02473510|Secondary|Percentage of Participants With Solicited Symptoms|Solicited symptoms are predefined symptoms or events specifically inquired about and assessed daily after vaccine administration up to 15 days after vaccination. The solicited symptoms include fever greater than (>) 100.0 degrees F (37.8 degrees Celsius), runny nose, sore throat, cough, vomiting, muscle aches, chills, decreased activity and headache. Results were reported for all solicited symptoms except fever >=101 degrees F (reported as primary outcome) within 8 days after vaccination and all solicited symptoms within 15 days after vaccination.|Baseline (Day 1) up to Day 8 and Day 15|The ITT population included all participants that were randomized and treated with investigational product.||Percentage of Participants|||Number
637739|NCT02473510|Primary|Percentage of Participants With Fever Greater Than or Equal to (>=) 101 Degrees Fahrenheit (F)|Percentage of participants with fever defined as oral temperature >=101 degrees F were reported.|Baseline (Day 1) up to Day 8|The intent-to-treat (ITT) population included all participants that were randomized and treated with investigational product.||Percentage of Participant|||Number
637740|NCT02473367|Primary|Plasma Concentration at 24 Hrs Post-dose (C24hr) of Raltegravir Following Once Daily Administration of Raltegravir|In Period 1 participants were treated with 1200 mg raltegravir alone; followed by Period 2 where participants were treated with 1200 mg raltegravir and three tablets of TUMS US 1000 taken orally concomitantly; followed by Period 3 where participants were treated with 1200 mg raltegravir and 12 hours later with 20 mL Leader Antacid MS taken orally; followed by Period 4 where participants were treated with 1200 mg raltegravir and 12 hours later with three tablets of TUMS US 1000 taken orally. The wait between Periods was a maximum of 7 days, during which participants were treated with 1200 mg raltegravir once daily. To determine the plasma concentration of raltegravir, blood samples were collected at 24 hours post-dose, and ANOVA modeling was performed on natural log-transformed values to derive geometric least-squares means.|24 hours post-dose|Per-Protocol: Participants who complied with the protocol sufficiently to ensure that generated data would reflect the effects of treatment, according to the underlying scientific model.||nM||95% Confidence Interval|Least Squares Mean
637741|NCT02473367|Primary|Maximum Plasma Concentration (Cmax) of Raltegravir Following Once Daily Administration of Raltegravir|In Period 1 participants were treated with 1200 mg raltegravir alone; followed by Period 2 where participants were treated with 1200 mg raltegravir and three tablets of TUMS US 1000 taken orally concomitantly; followed by Period 3 where participants were treated with 1200 mg raltegravir and 12 hours later with 20 mL Leader Antacid MS taken orally; followed by Period 4 where participants were treated with 1200 mg raltegravir and 12 hours later with three tablets of TUMS US 1000 taken orally. The wait between Periods was a maximum of 7 days, during which participants were treated with 1200 mg raltegravir once daily. To determine the plasma concentration of raltegravir, blood samples were collected from pre-dose up to 24 hours post-dose, and ANOVA modeling was performed on natural log-transformed values to derive geometric least-squares means.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose|Per-Protocol: Participants who complied with the protocol sufficiently to ensure that generated data would reflect the effects of treatment, according to the underlying scientific model.||nM||95% Confidence Interval|Least Squares Mean
637742|NCT02473367|Primary|Area Under the Plasma Concentration Time Curve From Time 0 to 24 Hrs (AUC 0-24hr) of Raltegravir Following Once Daily Administration of Raltegravir|In Period 1 participants were treated with 1200 mg raltegravir alone; followed by Period 2 where participants were treated with 1200 mg raltegravir and three tablets of TUMS Ultra Strength (US) 1000 taken orally concomitantly; followed by Period 3 where participants were treated with 1200 mg raltegravir and 12 hours later with 20 mL Leader Antacid Maximum Strength (MS) taken orally; followed by Period 4 where participants were treated with 1200 mg raltegravir and 12 hours later with three tablets of TUMS US 1000 taken orally. The wait between Periods was a maximum of 7 days, during which participants were treated with 1200 mg raltegravir once daily. To determine the plasma concentration of raltegravir, blood samples were collected from pre-dose up to 24 hours post-dose, and analysis of variance (ANOVA) modeling was performed on natural log-transformed values to derive geometric least-squares means.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose|Per-Protocol: Participants who complied with the protocol sufficiently to ensure that generated data would reflect the effects of treatment, according to the underlying scientific model.||hr*µM||95% Confidence Interval|Least Squares Mean
637743|NCT02472886|Secondary|For HIV/HCV- Coinfected Participants, Change From Baseline in CD4 T-cell Count at the End of Treatment and Posttreatment Week 4||Up to Posttreatment Week 4|Participant in the Safety analysis set (with or without prior antiretroviral (ARV) treatment) with available data were analyzed.||cells/µL||Standard Deviation|Mean
637744|NCT02472886|Secondary|Percentage of HIV/HCV- Coinfected Participants That Maintain HIV-1 RNA < 50 Copies/mL While on HCV Treatment and at Posttreatment Week 4||Up to Posttreatment Week 4|Participants in the Safety Analysis Set (who had HIV RNA < 50 Copies/mL at baseline) with available data were analyzed.||percentage of participants|||Number
637748|NCT02472886|Secondary|Percentage of Participants With Sustained Virologic Response (SVR) at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set||percentage of participants||95% Confidence Interval|Number
637749|NCT02472886|Primary|Percentage of Participants Who Discontinued Study Drug Due to Any Adverse Event (AE)||Up to 12 weeks|Safety Analysis Set||percentage of participants|||Number
637750|NCT02472886|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.|Posttreatment Week 12|Full Analysis Set (FAS) included participants who were enrolled into the study and received at least 1 dose of study drug.||percentage of participants||95% Confidence Interval|Number
637751|NCT02472847|Primary|BOLD Signal Measured by Functional Magnetic Resonance Imaging (fMRI)|Mean BOLD hippocampal signal during extinction learning and retention task in brain responsebetween the placebo (PBO) and the dronabinol (THC) group. Target areas are analyzed from fMRI scans. The scans were completed on days 1, 2, 3, and 9. Participants were randomized to the PBO and THC condition and received either placebo or dronabinol on day 2, 2 hours prior to extinction learning. Data from days 1, 2, 3, & 9 was combined and a single value was averaged for each group.|Day 1, 2, 3, & 9|The number of participants analyzed is 22 in the placebo group and 18 in the dronabinol group. The total number of participants who completed all 4 scanning sessions is 44. 4 participants were excluded from data analysis due to having poor quality fMRI data from any of the four sessions.||parameter estimates (arbitrary units)||Standard Deviation|Mean
637752|NCT02472756|Primary|Percentage of Participants Who Were Alive at Year 2||Year 2|ITT population.||percentage of participants|||Number
637753|NCT02472756|Primary|Percentage of Participants With Complete Remission (CR)|Lymphoma response was assessed using Cheson criteria. Criteria for CR (target lesions): Nodes returned to normal (if GTD >15 mm before therapy, GTD now ≤15 mm; if GTD 11-15 mm and SA >10 mm before therapy, SA now ≤ 10 mm) and all (non-nodal) target lesions completely resolved. Criteria for CR (non-target lesions): All non-target lymph nodes returned to normal size, all extra-nodal lesions have completely resolved, liver and spleen have returned to normal size (if enlarged at baseline).|Baseline until disease progression or death, whichever occurred first (up to approximately 6 months)|ITT population. Number of participants analyzed = participants who were evaluable for this outcome.||percentage of participants|||Number
637754|NCT02472756|Primary|Percentage of Participants With Objective Response|Lymphoma response was assessed using Cheson criteria. Objective response was defined as having either complete remission (CR) or partial remission (PR). Criteria for CR (target lesions): Nodes returned to normal (if greatest transverse diameter [GTD] greater than [>] 15 millimeters [mm] before therapy, GTD now less than or equal to [≤] 15 mm; if GTD 11-15 mm and short axis [SA] >10 mm before therapy, SA now ≤10 mm) and all (non-nodal) target lesions completely resolved. Criteria for CR (non-target lesions): All non-target lymph nodes returned to normal size, all extra-nodal lesions have completely resolved, liver and spleen have returned to normal size (if enlarged at baseline). Criteria for PR: Sum of the product of the diameters (SPD) of target lesions decreased at least 50 percent (%) from baseline and spleen and liver nodules regressed by 50% in SPD or single lesion in GTD.|Baseline until disease progression or death, whichever occurred first (up to approximately 6 months)|Intent-to treat (ITT) population. Number of participants analyzed = participants who were evaluable for this outcome.||percentage of participants|||Number
637755|NCT02472639|Secondary|Dehydration Related Hospital Admissions During Study Period|Study was prematurely terminated. Data was not collected or analyzed due to issue with study compliance.|3 months||||||
637756|NCT02472639|Secondary|Score on Additional QOL Questions Not Included in Stoma-QoL Questionnaire|Study was prematurely terminated. Data was not collected or analyzed due to issue with study compliance.|3 months||||||
637757|NCT02472639|Secondary|Number of Ostomy Bag Breakages During the Study Period|Study was prematurely terminated. Data was not collected or analyzed due to issue with study compliance.|3 months||||||
637758|NCT02472639|Secondary|Overall Satisfaction With Ostom-i Device|Study was prematurely terminated. Data was not collected or analyzed due to issue with study compliance.|3 months||||||
637759|NCT02472639|Primary|Patient Quality of Life as Measured by the 20-item Stoma-QOL Questionnaire at 1 Month and 3 Month Follow-up After Using the Ostomi-I Alert Versus Standard Stoma Care Without the Ostom-i Alert.||up to 3 Months|Study was prematurely terminated. Data was not collected or analyzed due to issue with study compliance.|||||
637760|NCT02472522|Post-Hoc|Percentage of Patients Needing Rescue Analgesic|Percentage of patients needing rescue analgesic. Rescue analgesia was provided with 6 mg of intravenous morphine and additional doses of 3 mg at 10 minutes interval till VAS was less than 3 or the development of adverse effects such as nausea and/or vomiting, respiratory depression (SpO2 <92%, ventilatory frequency rate <10), or occurrence of deep sedation (eyes closed >3 min, Ramsay Score RS >2).|24 hours|||percentage needing rescue analgesic|||Number
637761|NCT02472522|Other Pre-specified|Short Assessment of Patient Satisfaction Score (SAPS)|"Short assessment of patient satisfaction score(SAPS) was assessed on a 5 point scale at the end of 24 hours on the quality of postoperative analgesia. where:
highly dissatisfied
dissatisfied
neither dissatisfied nor satisfied
satisfied
highly satisfied"|24 hours|||Units on a scale||Standard Deviation|Mean
637762|NCT02472522|Other Pre-specified|Visual Analogue Scale on Coughing (VAS-C)|Visual Analogue Scale on Coughing (VAS-C) Was Used to Assess Post-operative Pain on Coughing. Where: 0 = no Pain and 10 = Worst Imaginable Pain. They were Recorded on Shifting to Postoperative and Then at 1, 4, 8, 12, 18 and 24 Hour|24 hours|||Units on a scale||Standard Deviation|Mean
637763|NCT02472522|Other Pre-specified|Visual Analogue Scale at Rest (VAS-R)|Visual Analogue Scale at rest (VAS-R) was used to assess Post-operative Pain at rest. Where: 0 = no Pain and 10 = Worst Imaginable Pain. They were Recorded on Shifting to Postoperative and Then at 1, 4, 8, 12, 18 and 24 Hour|24 hours|||Units on a scale||Standard Deviation|Mean
637764|NCT02472522|Other Pre-specified|Heart Rate: Postoperative|The Heart Rate of the patients were recorded after shifting from Operation Theater and at 1, 4, 8,12,18 and 24th hour after shifting to the postoperarive area.|24 hours|||beats/minute||Standard Deviation|Mean
637765|NCT02472522|Other Pre-specified|Mean Arterial Pressure (MAP): Postoperative Period|The Mean Arterial Pressure (MAP) of the patients were recorded after shifting from Operation Theater and at 1, 4, 8,12,18 and 24th hour after shifting to the postoperarive area.|24 hours|||millimeter of mercury (mmHg)||Standard Deviation|Mean
637767|NCT02472522|Other Pre-specified|Time to Complete Disappearance of Motor Block|"During the postoperative recovery, the level of motor block was assessed with Modified Bromage Scale 0 = no paralysis, able to flex hips/knees/ankles
= able to move knees, unable to raise extended legs
= able to flex ankles, unable to flex knees
= unable to move any part of the lower limb The time from subarachnoid block to complete disappearance of motor block (Bromage 0) was recorded in minutes."|24 hours|||minutes||Standard Deviation|Mean
637768|NCT02472522|Other Pre-specified|Heart Rate: Intraoperative Period|The Heart Rate of the patients were recorded from the start of surgery up to 60 minutes at 5, 10, 20, 30, 40, 50, 60 mins. No surgery lasted more than 60 minutes.|60 minutes|||beats/minute||Standard Deviation|Mean
637769|NCT02472522|Other Pre-specified|Mean Arterial Pressure (MAP): Intraoperative Period|The Mean Arterial Pressure (MAP) of the patients were recorded from the start of surgery up to 60 minutes at 5, 10, 20, 30, 40, 50, 60 mins. No surgery lasted more than 60 minutes.|Upto 60 minutes|||millimeter of mercury (mmHg)||Standard Deviation|Mean
637770|NCT02472522|Secondary|Adverse Effects Like Pruritus, Nausea and Vomiting||24 hours|||participants|||Number
637771|NCT02472522|Secondary|Total Dose of Required Morphine in 24 Hours Postoperatively||24 hours|Only the mentioned number of patients needed analgesia within the first 24 hours postoperatively||Milligrams||Standard Deviation|Mean
637772|NCT02472522|Primary|The Time After the TAP Block When Rescue Analgesia Was First Sought||24 hours|Number of patients who sought rescue analgesic within the first 24 hours postoperatively. Rest of the studied patients needed no rescue analgesic within the first 24 hours postoperatively.||Hours||Standard Deviation|Mean
637773|NCT02472366|Post-Hoc|Change in Best Corrected Visual Acuity From Baseline|A subgroup analysis was performed in which only pseudophakic subjects were included. Best Corrected Visual Acuity is measured using an ETDRS eye chart and is reported as the number of letters read correctly in the study and/or fellow eye.|Change from Baseline to 12 months post ILUVIEN administration|"For the Laser arm group, 6 patients were enrolled and 7 eyes were treated with ILUVIEN"||Best Corrected VA Letter Score|Participants|Standard Deviation|Mean
637774|NCT02472366|Secondary|Changes in Macular Volume||Change from Baseline to 12 months post ILUVIEN administration|"For laser arm group, 6 patients were enrolled with 7 eyes receiving ILUVIEN"||mm^3|Participants|Standard Deviation|Mean
637775|NCT02472366|Secondary|Changes in Central Subfield Thickness||Change from Baseline to 12 months post ILUVIEN administration|"For Laser arm group, there were 6 patients enrolled but 7 eyes treated"||microns|Participants|Standard Deviation|Mean
637776|NCT02472366|Secondary|Changes in Intraocular Pressure (IOP)||Change from Baseline to 12 months post ILUVIEN administration|"for laser arm group, 6 patients enrolled with 7 eyes receiving ILUVIEN"||mmHg|Participants|Standard Deviation|Mean
637777|NCT02472366|Primary|Changes in Best Corrected Visual Acuity From Baseline|Best Corrected Visual Acuity is measured using an ETDRS eye chart and is reported as the number of letters read correctly in the study and/or fellow eye.|Change from Baseline to 12 months post ILUVIEN administration|"For the Laser arm group, 6 patients were enrolled and 7 eyes were treated with ILUVIEN"||Best Corrected VA Letter Score|Participants|Standard Deviation|Mean
637778|NCT02471755|Secondary|Change of E2 From Baseline|Serum sample of participants was examined at the 2nd to 4th day of menstrual period; if the participant was not in menstrual period, Serum sample would be tested in coming cycle length; for participants in menopause period, Serum sample was examined at the end of the week of 8th and 20th.|week8,week20|||pmol/l||Inter-Quartile Range|Median
637779|NCT02471755|Secondary|Change of FSH/LH From Baseline|Serum sample of participants was examined at the 2nd to 4th day of menstrual period; if the participant was not in menstrual period, Serum sample would be tested in coming cycle length; for participants in menopause period, Serum sample was examined at the end of the week of 8th and 20th.|week8,week20|||ratio||Inter-Quartile Range|Median
637780|NCT02471755|Secondary|Change of LH From Baseline|Serum sample of participants was examined at the 2nd to 4th day of menstrual period; if the participant was not in menstrual period, Serum sample would be tested in coming cycle length; for participants in menopause period, Serum sample was examined at the end of the week of 8th and 20th.|week8,week20|||mIU/ml||Inter-Quartile Range|Median
637781|NCT02471755|Secondary|Change of FSH From Baseline|Serum sample of participants was examined at the 2nd to 4th day of menstrual period; if the participant was not in menstrual period, Serum sample would be tested in coming cycle length; for participants in menopause period, Serum sample was examined at the end of the week of 8th and 20th.|week8,week20|||mIU/ml||Inter-Quartile Range|Median
637782|NCT02471755|Secondary|Change of MRS (Menopause Rating Scale) From Baseline|MRS(Menopause Rating Scale) was designed to measure MT symptoms and to explore the influences on life qualities in a standardized way. In MRS, symptoms such as impaired memory, depression, insomnia, sweating, hot flashes, nervousness, joints complaints, lack of concentration were evaluated and calculated in numbers to describe the situation of patient. Scores on MRS range from 0 to 44, with higher scores indicating more severe symptoms.|week8;wee4,20,32|||Scores on a scale||Inter-Quartile Range|Median
637783|NCT02471755|Primary|Change of Average 24 h Hot Flash Score From Baseline|Every day during the 4th, 8th, 20th, and 32nd weeks, symptoms and specific times of hot flashes were recorded in hot flash diaries by the participants.Data from weeks 4, 20 and 32 were recorded as the second time frame.According to the severity categories suggested by Food and Drug Administration (FDA), hot flashes were assessed as mild, moderate, or severe. Hot flash scores are calculated as (hot flash frequency x severity)/7, with severity scores ranging from 1=mild 2=moderate to 3=severe.|week8;wee4,20,32|||Scores on a scale||Inter-Quartile Range|Median
637784|NCT02471612|Secondary|Patients Needing Re-exploration|Number of patients needing return to the operation theater for surgery for the same pathology or any other complication arising out of the initial surgery|30 days|||participants|||Number
637785|NCT02471612|Secondary|Number of Participants With Acute Kidney Injury (AKI)|"Acute Kidney Injury (AKI) was diagnosed based on the Kidney Disease: Improving Global Outcomes (KDIGO) Acute Kidney Injury Work Group (2012) guidelines
Increase in Serum Creatinine (S. Cr) by ≥0.3 mg/dl (≥ 26.5 μmol/l) within 48 hours; OR
Increase in S. Cr to ≥1.5 times baseline, which is known or presumed to have occurred within prior 7 days; OR
Urine volume <0.5 ml/kg/h for 6 hours"|30 days|||participants|||Number
637786|NCT02471612|Secondary|Cardiac Morbidity (AMI or Arrhythmias Needing Treatment)|Number of patients noted to have Cardiac morbidity: Acute myocardial infarction (AMI) or arrhythmias needing treatment|30 days|||participants|||Number
637790|NCT02471612|Primary|Area Under the Receiver Operating Curve (ROC) as a Measure of the Accuracy of the APACHE II and P-POSSUM Scoring Systems to Predict Mortality|Participants will be followed for the duration of hospital stay (expected average of 30 days) and mortality was noted.All patients undergoing emergency laparotomy at Tata Main Hospital form 01st December 2013 to 30th November 2014 were included in the study. All patients were scored with APACHE II and P-POSSUM scoring systems on the day of surgery. Area under the curve (AUC) is used to measure the “size” of the prediction composed by the graphic display between the ‘sensitivity’ and the ‘1–specificity’ relationship. AUC can range from 0.5 to 1.0 and a result of 1.0 indicates a perfect discriminatory ability. An AUC value > 0.8 is considered good, a range between 0.60-0.80 is considered as moderate, and an AUC value < 0.60 is regarded as poor. For APACHE-II, a cut off score of >/=24 was determined; for P-POSSUM, a cut off score of >/= 63 was determined.|30 days|All patients undergoing emergency laparotomy at Tata Main Hospital form December 2013 to November 2014 were scored with APACHE II & P-POSSUM scoring systems on the day of surgery. The patients were followed up till at least 30 days after discharge or death (during admission or within 30 days after discharge).||probability of accurate prediction||95% Confidence Interval|Number
637791|NCT02470949|Primary|Percent of Calories Consumed Following the Experimental Manipulation|The participants will be provided with an ad libitum lunch for 30 minutes following the completion of their manipulated social status condition.|Administered 30 days apart|||percent||Standard Deviation|Mean
637792|NCT02470949|Primary|The Macronutrient Composition of Foods Consumed|The participants will be provided with an ad libitum lunch for 30 minutes following the completion of their manipulated social status condition.|Administered 30 days apart|||grams||Standard Deviation|Mean
637793|NCT02470949|Primary|Calories Consumed Following the Experimental Manipulation|The participants will be provided with an ad libitum lunch for 20 minutes following the completion of their manipulated social status condition.|Administered 30 days apart|||kcal||Standard Deviation|Mean
637794|NCT02470494|Other Pre-specified|Adverse Events|All adverse events will be recorded on case report forms and determinations will be made as to the whether the events are Adverse Events, Serious Adverse Events, Unanticipated Adverse Device Effects and/or related to the investigational device or the procedure.|Baseline and up to 90-day.|||Participants|||Count of Participants
637795|NCT02470494|Secondary|Change in Subject's Self-Perceived Ability to Communicate.|The change in the subject's self-perceived ability to communicate with the use of the EarLens Device (CHD) when compared to baseline condition was measured using the validated Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire. The APHAB produces scores for 4 subscales: Ease of Communication (EC), Reverberation (RV), Background Noise (BN), and Aversiveness (AV), which all range from 0-99%. A global score is computed by averaging the EC, RV, and BN subscores. For an individual score (either unaided alone or aided alone), a higher number indicates poorer performance, or more difficulty experienced. For this outcome measure, the difference between the average of the global unaided and aided scores is computed to determine the reduction (if any) in self-perceived difficulty, so a larger number in this outcome measure indicates better performance, as more of the difficulty has been reduced from the unaided condition by going to the aided condition.|Baseline and up to 90-day.|40 subjects available for analysis between enrollment/treatment and 90-day measurement.||percentage of perceived benefit||Standard Deviation|Mean
637796|NCT02470494|Secondary|Change in Functional Gain Over the Frequency Range From 2000 to 10,000 Hz.|10 dB (decibel) change in the average pure tone thresholds for the subject population over the frequency range from 2000 to 10,000 Hz (2000, 3000, 4000, 6000, 8000, and 10,000 Hz). Measurement to be used in analysis are the baseline unaided soundfield (SF) thresholds measured prior to device placement and the aided soundfield thresholds measured 90-day post placement. Analysis includes calculation of the unaided soundfield thresholds minus aided soundfield thresholds|Baseline and up to 90-day.|40 subjects available for analysis between enrollment/treatment and 90-day measurement.||dB difference in SF Hearing Thresholds||Standard Deviation|Mean
637797|NCT02470494|Secondary|Change in Speech Understanding in Noise.|"The change in aided speech reception thresholds (SRTs) when compared to the baseline unaided condition was measured using a validated speech test, the HINT 90.
Change in aided HINT 90 SRTs when compared to the baseline unaided condition. SRTs will be measured using HINT materials with the signal (speech level presented from 0 degrees) adapted relative to the noise (presented from 90 degrees held fixed at 60 dB SPL) to determine the signal-to-noise ratio for reporting the whole sentence correct 50% of the time (Nilsson et al., 1994). An improvement in HINT score is indicated as a negative (-) dB value change. A more negative value indicating an improvement of understanding speech and noise. An improvement of -1dB is equivalent to a 10% improvement in understanding speech and noise and is likely of clinical benefit. HINT 90 will be measured twice and averaged to obtain the per subject HINT SRT. All subject data will be averaged to obtain the means."|Baseline and up to 90-day.|28 subjects available for analysis between enrollment/treatment and 90-day measurement.||dB difference in HINT scores||Standard Deviation|Mean
637798|NCT02470494|Primary|Change in Hearing Stability Using Unaided Air Conduction Thresholds.|"Hearing sensitivity was monitored using earphones with the TMT (Tympanic Membrane Transducer) in place, but with the audio processor removed. Baseline and study end measurements were compared. A PTA4 (Pure Tone Average at 4 frequencies; 500, 1000, 2000 and 4000 Hz) was computed both for baseline unaided hearing post-placement with TMT in place, and unaided hearing with TMT in place at the 90-day for each ear, then averaged across both ears for each subject. A determination of No Hearing Change for the subject was made if the calculated hearing changes of the subject population are 10dB or less."|Baseline and up to 90-day.|40 subjects available for analysis between enrollment and 90-day measurement.||dB difference in Unaided Hearing||Standard Deviation|Mean
637799|NCT02470429|Secondary|Change From Baseline in Tear Film Break-up Time (TFBUT) at Day 42|TFBUT is defined as the time elapsed from the last blink until 1 or more dry spots appeared in the precorneal tear film. A longer tear film break-up time indicates a more stable tear film and may lead to improvement in dry eye symptoms. One eye (study eye) contributed to the analysis.|Baseline (Day 0), Day 42|ITT Analysis Set. Number Analyzed is the number of subjects with non-missing response.||seconds||Standard Error|Least Squares Mean
637813|NCT02470403|Secondary|Time to Maximum Plasma Concentration of LIK066 at Steady State (Tmax, ss) in Part 1 of the Study|Blood samples were collected at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 24 h post-dose on Day 84. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects.|Day 84|The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data.||hour||Full Range|Median
637800|NCT02470429|Secondary|Change From Baseline in IDEEL Treatment Inconvenience Score at Day 42|The IDEEL is 10-question patient-reported outcome questionnaire that assesses the subject's general satisfaction with treatment use. A resultant overall 0-100 satisfaction score was calculated, with a higher score indicating greater satisfaction and less treatment-related bother.|Baseline (Day 0), Day 42|ITT Analysis Set. Number Analyzed is the number of subjects with non-missing response.||units on a scale||Standard Error|Least Squares Mean
637801|NCT02470429|Secondary|Change From Baseline in IDEEL Treatment Effectiveness Score at Day 42|The IDEEL is 10-question patient-reported outcome questionnaire that assesses the subject's general satisfaction with treatment use. A resultant overall 0-100 satisfaction score was calculated, with a higher score indicating greater satisfaction and less treatment-related bother.|Baseline (Day 0), Day 42|ITT Analysis Set. Number Analyzed is the number of subjects with non-missing response.||units on a scale||Standard Error|Least Squares Mean
637802|NCT02470429|Primary|Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 42|The TOSS score is a cumulative cornea and conjunctival staining score. After instilling ophthalmic dye in the eye, the investigator graded 3 areas of the ocular surface for dryness on a scale from 0 to 5, where 0=Absent and 5=Severe. The 3 scores were summed for a resultant overall 0-15 score. A more negative change value indicates greater efficacy. One eye (study eye) contributed to the analysis.|Baseline (Day 0), Day 42|ITT Analysis Set. Number Analyzed is the number of subjects with non-missing response.||units on a scale||Standard Error|Least Squares Mean
637803|NCT02470403|Secondary|The Apparent Volume of Distribution of LIK066 During the Terminal Elimination Phase Following Extra Vascular Administration (Vz/F) in Part 2 of the Study|Blood samples were collected at pre-dose, 0.5, 1, 2, 3, 4, 4.5, 5, 6, 7 and 9 h post-dose on Day 1 and 14. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects. Day 14 data reports Vz/F at steady state (Vz/F, ss)|Day 1, Day 14|The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data.||Liter||Standard Deviation|Mean
637804|NCT02470403|Secondary|The Apparent Systemic Clearance at Steady State (CLss/F) of LIK066 Following Extra Vascular Administration in Part 2 of the Study|Blood samples were collected at pre-dose, 0.5, 1, 2, 3, 4, 4.5, 5, 6, 7 and 9 h post-dose on Day 1 and 14. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects. Day 14 data reports CLss/F at steady state (CLss/F, ss)|Day 1, Day 14|The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data.||Liter/hour||Standard Deviation|Mean
637805|NCT02470403|Secondary|Area Under the Plasma Concentration-time Profile to the Time of Next Dosing (AUCtau) of LIK066 in Part 2 of the Study|Blood samples were collected at pre-dose, 0.5, 1, 2, 3, 4, 4.5, 5, 6, 7 and 9 h post-dose on Day 1 and 14. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects. The linear trapezoidal rule was used for AUC calculation. Day 14 data reports AUCtau at steady state (AUCtau, ss)|Day 1, Day 14|The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data.||hr*ng/mL||Standard Deviation|Mean
637806|NCT02470403|Secondary|Area Under the Plasma Concentration-time Profile to the Time of the Last Quantifiable Concentration (AUClast) of LIK066 in Part 2 of the Study|Blood samples were collected at pre-dose, 0.5, 1, 2, 3, 4, 4.5, 5, 6, 7 and 9 h post-dose on Day 1 and 14. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects. The linear trapezoidal rule was used for AUC calculation. Day 14 data reports AUClast at steady state (AUClast, ss)|Day 1, Day 14|The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data.||hr*ng/mL||Standard Deviation|Mean
637807|NCT02470403|Secondary|Time to Maximum Plasma Concentration of LIK066 (Tmax) in Part 2 of the Study|Blood samples were collected at pre-dose, 0.5, 1, 2, 3, 4, 4.5, 5, 6, 7 and 9 h post-dose on Day 1 and 14. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects. Day 14 data reports Tmax at steady state (Tmax, ss)|Day 1, Day 14|The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data.||hour||Full Range|Median
637808|NCT02470403|Secondary|Maximum Plasma Concentration of LIK066 (Cmax) in Part 2 of the Study|Blood samples were collected at pre-dose, 0.5, 1, 2, 3, 4, 4.5, 5, 6, 7 and 9 h post-dose on Day 1 and 14. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects. Day 14 data reports Cmax at steady state (Cmax, ss)|Day 1, Day 14|The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data.||ng/mL||Standard Deviation|Mean
637809|NCT02470403|Secondary|The Apparent Volume of Distribution of LIK066 During the Terminal Elimination Phase Following Extra Vascular Administration at Steady State (Vz/F, ss) in Part 1 of the Study|Blood samples were collected at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 24 h post-dose on Day 84. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects.|Day 84|The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data.||Liter||Standard Deviation|Mean
637810|NCT02470403|Secondary|The Apparent Systemic Clearance at Steady State (CLss/F, ss) of LIK066 Following Extra Vascular Administration in Part 1 of the Study|Blood samples were collected at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 24 h post-dose on Day 84. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects.|Day 84|The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data.||Liter/hour||Standard Deviation|Mean
637811|NCT02470403|Secondary|Area Under the Plasma Concentration-time Profile to the Time of Next Dosing at Steady State (AUCtau, ss) of LIK066 in Part 1 of the Study|Blood samples were collected at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 24 h post-dose on Day 84. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects. The linear trapezoidal rule was used for AUC calculation.|Day 84|The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data.||hr*ng/mL||Standard Deviation|Mean
637812|NCT02470403|Secondary|Area Under the Plasma Concentration-time Profile to the Time of the Last Quantifiable Concentration at Steady State (AUClast, ss) of LIK066 in Part 1 of the Study|Blood samples were collected at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 24 h post-dose on Day 84. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects. The linear trapezoidal rule was used for AUC calculation.|Day 84|The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data.||hr*ng/mL||Standard Deviation|Mean
637814|NCT02470403|Secondary|Maximum Plasma Concentration of LIK066 at Steady State (Cmax ss) in Part 1 of the Study|Blood samples were collected at predose, 0.5, 1, 1.5, 2, 3, 4, 6 and 24 h postdose on Day 84. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects.|Day 84|The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data.||ng/mL||Standard Deviation|Mean
637815|NCT02470403|Secondary|Part 2: Percent Change in Body Weight From Baseline to Week 2 (Day 14) in LIK066 Twice Daily and LIK066 Three Times Daily Arms|"Triplicate body weight measurements at each visit were averaged and represented body weight at that visit. Baseline was defined to be the body weight at the last visit prior to the first treatment. Baseline is defined as Day 1 predose.
Percent change is calculated as [(post baseline- Baseline) /Baseline] * 100. A longitudinal mixed effects model for percent change in body weight was used.
The longitudinal mixed effects model included fixed effects of treatment, time, glycemic status (a stratification factor for randomization), the treatment-by-time interaction, the treatment-by-glycemic status interaction, the time-by-glycemic status interaction, the treatment-by-time-by-glycemic status interaction, a random effect for study part and baseline body weight as a covariate."|Baseline, Week 2|The pharmacodynamics (PD) analysis set included all subjects with available PD data and no protocol deviations with relevant impact on PD data. The analysis is based on all subjects with a Baseline body weight and at least one post-Baseline body weight measurement.||percent change||80% Confidence Interval|Least Squares Mean
637816|NCT02470403|Primary|Part 2: Number of Patients With Any Adverse Events, Serious Adverse Events and Death|This endpoint reports patients with at least one AE (any AE), serious AE and death|2 weeks|The safety analysis set included all subjects that received any study drug.||Patients|||Number
637817|NCT02470403|Primary|Part 1 and Part 2: Percent Change in Body Weight From Baseline to Week 2 (Day 14)|"Triplicate body weight measurements at each visit were averaged and represented body weight at that visit. Baseline was defined to be the body weight at the last visit prior to the first treatment. Part 1: Baseline is defined as Day -1. Part 2: Baseline is defined as Day 1 predose.
Percent change is calculated as [(post baseline- Baseline) /Baseline] * 100. A longitudinal mixed effects model for percent change in body weight was used.
The longitudinal mixed effects model included fixed effects of treatment, time, glycemic status (a stratification factor for randomization), the treatment-by-time interaction, the treatment-by-glycemic status interaction, the time-by-glycemic status interaction, the treatment-by-time-by-glycemic status interaction, a random effect for study part and baseline body weight as a covariate."|Baseline, Week 2 (Day 14)|Pharmacodynamic set. The analysis was based on all subjects with a baseline body weight and at least one post-Baseline body weight measurement. Only data from common time points in Part 1 and Part 2 were included in the analysis, i.e., Baseline and Day 14.||Percent change||80% Confidence Interval|Least Squares Mean
637818|NCT02470403|Primary|Part 1: Number of Patients With Any Adverse Events, Serious Adverse Events and Death|This endpoint reports patients with at least one AE (any AE), serious AE and death.|12 weeks|The safety analysis set included all subjects that received any study drug.||Patients|||Number
637819|NCT02470403|Primary|Part 1: Percent Change in Body Weight From Baseline to Week 12|"Triplicate body weight measurements at each visit were averaged and represented body weight at that visit. Baseline was defined to be the body weight at the last visit prior to the first treatment. Baseline is Day -1 in Part 1. Percent change is calculated as [(post baseline- Baseline) /Baseline] * 100.
A longitudinal mixed effects model for percent change in body weight was used. The model included fixed effects of treatment, time, glycemic status (a stratification factor for randomization), the treatment-by- time interaction, the treatment-by-glycemic status interaction, the time-by-glycemic status interaction, and the treatment-by-time-by-glycemic status interaction, and Baseline body weight as a covariate."|Baseline, Week 12 (Day 85)|The pharmacodynamics (PD) analysis set included all subjects with available PD data and no protocol deviations with relevant impact on PD data. The analysis is based on all subjects with a Baseline body weight and at least one post-Baseline body weight measurement.||percent change||80% Confidence Interval|Least Squares Mean
637820|NCT02469961|Secondary|Total Narcotic Used by Each Participant|the use for morphine and/or fentanyl and or Demerol converted to morphine equivalents|Participants will be followed from the start of sedation until discharge: approximately 3-5 hr|||Microgram||Standard Deviation|Mean
637821|NCT02469961|Secondary|Number of Participants That Have Either Bradycardia or Hypotension|Number of participants observed with Bradycardia or Hypotension who required intervention|Participants will be followed from the start of sedation until discharge: approximately 3-5 hr|Number of patients who had Bradycardia or hypotension||participants|||Number
637822|NCT02469961|Secondary|Post Anesthesia Care Unit (PACU) Length of Stay|length of stay in minutes in the Post Anesthesia Care Unit before discharge|Arrival in the PACU until discharge either to home or to a hospital in-patient bed approximately 1-3 hr after the operation|||Minutes||Standard Deviation|Mean
637823|NCT02469961|Primary|Number of Participants That Need an Airway Intervention.|airway manipulation or repositioning: apnea, oral airway, adjust head|Participants will be followed from the start of sedation until discharge: approximately 3-5 hr|||participants|||Number
637824|NCT02469597|Secondary|Length of Hospital Stay||Participants will be followed for the duration of hospital stay up to 1 week|||Days||Standard Error|Least Squares Mean
637825|NCT02469597|Secondary|Patient Needing Endotracheal Intubation||Within 72 hours of medication administration|||participants|||Number
637826|NCT02469597|Primary|Oxygen Saturation||4 hours after medication adminstration|||Percentage change in oxygen saturation||Standard Error|Least Squares Mean
637827|NCT02469597|Primary|Oxygen Saturation||2 hours after medication adminstration|||Percentage change in oxygen saturation||Standard Error|Least Squares Mean
637828|NCT02469597|Primary|Respiratory Rate||4 hours after medication adminstration|||Percentage change in respiratory rate||Standard Error|Least Squares Mean
637829|NCT02469597|Primary|Respiratory Rate||2 hours after medication adminstration|||Percentage change in respiratory rate||Standard Error|Least Squares Mean
637830|NCT02469298|Secondary|Number of Participants With no Detectable Influenza Viral RNA by Quantitative Virus Culture From Nasopharyngeal Swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14|Number of participants with no detectable influenza viral RNA by quantitative virus culture from nasopharyngeal swabs on Baseline (Day1), Day 3, Day 5, Day 8 and Day 14 were recorded. Assessments recorded on Day 1 were considered as Baseline.|Up to Day 14|IPP Population. Only those participants (number with nasopharyngeal samples) available at the specified time points were analyzed.||Participants|||Count of Participants
637831|NCT02469298|Secondary|Change From Baseline in Influenza Viral Load as Measured by Quantitative Virus Culture From Nasopharyngeal Swabs on Day 3, Day 5, Day 8 and Day 14|Influenza viral load as measured by quantitative virus culture from nasopharyngeal swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14 was recorded. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.|Baseline (Day 1) and Day 3, Day 5, Day 8 and Day 14|IPP population. Only those participants available at the specified time points were analyzed.||Log median tissue culture infective dose||Standard Deviation|Mean
637832|NCT02469298|Secondary|Total Dose of Relief Medication|Use of study supplied relief medications (paracetamol and dextromethorphan for symptom relief were recorded in the eDiary and accordingly number of participants using these medications were recorded. The total dose of these relief medications used by these participants are presented.|Up to Day 28/withdrawal|Safety population. Only those participants using relief medication were analyzed.||Milligrams||Full Range|Median
637833|NCT02469298|Secondary|Number of Participants With no Detectable Influenza Viral RNA by qRT-PCR From Nasopharyngeal Swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14|Number of participants with no detectable influenza viral ribonucleic acid (RNA) by qRT-PCR from nasopharyngeal swabs on Baseline (Day1), Day 3, Day 5, Day 8 and Day 14 were recorded. Assessments recorded on Day 1 were considered as Baseline.|Up to Day 14|IPP Population. Only those participants available at the specified time points were analyzed.||Participants|||Count of Participants
637834|NCT02469298|Secondary|Change From Baseline in Influenza Viral Load as Measured by Quantitative Reverse Transcription-polymerase Chain Reaction (qRT-PCR) From Nasopharyngeal Swabs on Day 3, Day 5, Day 8 and Day 14|Influenza viral load as measured by quantitative reverse transcription - polymerase chain reaction (qRT-PCR) from nasopharyngeal swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14 was recorded. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.|Baseline (Day 1) and Day 3, Day 5, Day 8 and Day 14|IPP population. Only those participants available at the specified time points were analyzed.||Log viral particles/mL||Standard Deviation|Mean
637835|NCT02469298|Secondary|Number of Hospital Admissions Due to Influenza Infection|Number of participants admitted in hospital due to influenza infection was recorded.|Up to Day 28/withdrawal|Safety population||Participants|||Number
637836|NCT02469298|Secondary|Number of Participants Who Used Relief Medication|Use of study supplied relief medications (paracetamol and dextromethorphan for symptom relief were recorded in the eDiary and accordingly number of participants using these medications were recorded.|Up to Day 28/withdrawal|Safety population.||Participants|||Count of Participants
637837|NCT02469298|Secondary|Number of Afebrile Participants Over Time Post Initiation of Treatment|Afebrile participants were defined as participants with oral temperature <=37.2 degree Celsius, <=99.0 degree Fahrenheit over time post initiation of treatment. Temperature was taken orally and recorded in the eDiary, thrice daily from Day 1 to Day 5 (morning, noon, evening) and twice daily (morning, evening) from Day 6 to Day 14 by the participant using a digital thermometer provided by the study. For participants whose fever was not resolved by the Day 14 visit then after Day 14, participants continued to take oral temperature twice daily until temperature <=37.2 degree Celsius or <=99 degree Fahrenheit for 24 hours.|Up to Day 28/withdrawal|IPP population. Only those participants available at the specified time points were analyzed.||Participants|||Count of Participants
637838|NCT02469298|Secondary|Time to Resolution of Fever Over Time Post Initiation of Treatment|Time to resolution of fever was defined as the time when oral temperature was <= 37.2 degree Celsius (<=99.0 degree Fahrenheit) for at least 24 hours (with one hour window) without having taken any antipyretic medication for at least 4 hours. Temperature was taken orally and recorded in the eDiary, thrice daily from Day 1 to Day 5 (morning, noon, evening) and twice daily (morning, evening) from Day 6 to Day 14 by the participant using a digital thermometer provided by the study. For participants whose fever was not resolved by the Day 14 visit then after Day 14, participants continued to take oral temperature twice daily until temperature <=37.2 degree Celsius or <=99 degree Fahrenheit for 24 hours.|Up to Day 28/withdrawal|Influenza positive population (IPP) comprised of all randomized participants who received at least one dose of IP with proven influenza infection (positive rapid antigen test and positive influenza by quantitative reverse transcription-polymerase chain reaction (qRT-PCR) or culture test at any time point). Participants with fever are analyzed.||Hours||Full Range|Median
637839|NCT02469298|Primary|Number of Participants With DRE of Interest-associated Antibiotic Use|Use of antibiotics for DREs of interest was monitored. Roxithromycin was used for DRE sinusitis by one participant.|Up to Day 28/withdrawal|Safety population||Participants|||Count of Participants
637840|NCT02469298|Primary|Number of Participants With Disease Related Events (DREs) of Interest|Disease-related events of interest included Otitis media, Sinusitis, Bronchitis and Pneumonia and were captured separately from AEs and SAEs. DREs of interest were assessed and recorded by the site on all clinical visit days.|Up to Day 28/withdrawal|Safety population||Participants|||Count of Participants
637841|NCT02469298|Primary|Change From Baseline in Electrocardiogram (ECG) Parameters|12-lead ECGs were obtained on Day 1, Day 3 and Day28/withdrawal using an ECG machine that automatically calculates and measures RR, PR, QRS, QT, and Corrected QT Interval using Bazette’s formula (QTcB) and Corrected QT Interval using Fridericia forumula (QTcF) intervals. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.|Baseline (Day 1) and up to Day 28/withdrawal|Safety population. Only those participants available at the specified time points were analyzed.||Millisecond (msec)||Standard Deviation|Mean
637842|NCT02469298|Primary|Change From Baseline in Vital Signs- Percent Oxygen in Blood (POB)|Vital signs were measured in semi-supine position after 5 minutes rest and included POB. POB was obtained on Baseline (Day 1), Day 3, Day 5, Day 8, Day 14 and Day 28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.|Baseline (Day 1) and up to Day 28/withdrawal|Safety population. Only those participants available at the specified time points were analyzed.||Percentage (%)||Standard Deviation|Mean
637843|NCT02469298|Primary|Change From Baseline in Vital Signs- Temperature|Vital signs were measured in semi-supine position after 5 minutes rest and included temperature. Oral temperature was obtained on Day 1, Day 3, Day 5, Day 8, Day 14 and Day 28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.|Baseline (Day 1) and up to Day 28/withdrawal|Safety population. Only those participants available at the specified time points were analyzed.||Centigrade||Standard Deviation|Mean
637844|NCT02469298|Primary|Change From Baseline in Vital Signs- Respiration Rate (RR)|Vital signs were measured in semi-supine position after 5 minutes rest and included RR. RR was obtained on Day 1, Day 3, Day 5, Day 8, Day 14 and Day 28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.|Baseline (Day 1) and up to Day 28/withdrawal|Safety population. Only those participants available at the specified time points were analyzed.||Breaths per minute||Standard Deviation|Mean
637845|NCT02469298|Primary|Change From Baseline in Vital Signs- Heart Rate (HR)|Vital signs were measured in semi-supine position after 5 minutes rest and included HR. Three readings of pulse rate were taken; the first reading was rejected and the second and third readings were averaged to give the measurement to be recorded. Vital signs were obtained on Day 1, Day 3, Day 5, Day 8, Day 14 and Day 28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.|Baseline (Day 1) and up to Day 28/withdrawal|Safety population. Only those participants available at the specified time points were analyzed.||Beats per minute||Standard Deviation|Mean
637846|NCT02469298|Primary|Change From Baseline in Vital Signs- Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)|Vital signs were measured in semi-supine position after 5 minutes rest and included systolic and diastolic blood pressure. Three readings of blood pressure were taken; the first reading was rejected and the second and third readings were averaged to give the measurement to be recorded. Vital signs were obtained on Baseline (Day 1), Day 3, Day 5, Day 8, Day 14 and Day 28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.|Baseline (Day 1) and up to Day 28/withdrawal|Safety population. Only those participants available at the specified time points were analyzed.||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
637847|NCT02469298|Primary|Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Protein (Dipstick)|The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of urine protein can be read as negative, Trace, 1+, 2+, 3+ and 4+, indicating proportional concentrations in the urine sample. Assessments recorded on Day 1 were considered as Baseline.|Up to Day 28/withdrawal|Safety population||Participants|||Count of Participants
637848|NCT02469298|Primary|Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Glucose (Dipstick)|The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of urine glucose can be read as negative, Trace, 1+ or 1/4 gram per deciliter (G/dL), 2+ OR 1/2 G/dL, 3+ or 1 G/dL and 4+ indicating proportional concentrations in the urine sample. Assessments recorded on Day 1 were considered as Baseline.|Up to Day 28/withdrawal|Safety population||Participants|||Count of Participants
637849|NCT02469298|Primary|Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Occult Blood (Dipstick)|The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of urine occult blood can be read as negative, Trace, 1+, 2+, 3+ and 4+, indicating proportional concentrations in the urine sample. Assessments recorded on Day 1 were considered as Baseline.|Up to Day 28/withdrawal|Safety population.||Participants|||Count of Participants
637850|NCT02469298|Primary|Change From Baseline in Urinalysis Parameters- Urine Specific Gravity|Urinalysis parameter included Urine specific gravity and was measured on Day 1, Day 5 and Day 28. Urinary specific gravity is a measure of the concentration of solutes in the urine. It measures the ratio of urine density compared with water density and provides information on the kidney's ability to concentrate urine. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.|Baseline (Day 1), Day 5 and Day 28/withdrawal|Safety population. Only those participants available at the specified time points were analyzed.||Ratio||Standard Deviation|Mean
637851|NCT02469298|Primary|Change From Baseline in Urinalysis Parameters- Urine pH|Urinalysis parameters included urine pH. pH is calculated on a scale of 0 to 14, such that, the lower the number, more acidic the urine and higher the number, more alkaline the urine with 7 being neutral. Urinalysis was done on Day 1, Day 5 and Day 28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.|Baseline (Day 1), Day 5 and Day 28/withdrawal|Safety population. Only those participants available at the specified time points were analyzed.||Points on a scale||Standard Deviation|Mean
637852|NCT02469298|Primary|Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN)|Clinical chemistry parameters included Calcium, CO2 content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/(BUN). Blood samples were collected on Day 1, Day 3, Day 5 and Day 28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.|Baseline (Day 1) and up to Day 28/withdrawal|Safety population. Only those participants available at the specified time points were analyzed.||Millimoles per Liter (MMOL/L)||Standard Deviation|Mean
637853|NCT02469298|Primary|Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid|Clinical chemistry parameters included Direct Bilirubin, Total Bilirubin, Creatinine and Uric acid. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.|Baseline (Day 1) and up to Day 28/withdrawal|Safety population. Only those participants available at the specified time points were analyzed.||Micromole per Liter (UMOL/L)||Standard Deviation|Mean
637854|NCT02469298|Primary|Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT)|Clinical chemistry parameters included Alkaline phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase and Gamma Glutamyl Transferase. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.|Baseline (Day 1) and up to Day 28/withdrawal|Safety population. Only those participants available at the specified time points were analyzed.||International Units per litre (IU/L)||Standard Deviation|Mean
637884|NCT02467075|Secondary|Hospital Length of Stay|Subject's hospital length of stay in days|Duration of hospital stay (assessed from date of randomization up to 30 days)|||days|days|Standard Deviation|Mean
637885|NCT02467075|Secondary|Subjects Requiring Renal Replacement Therapy (Kidney Transplant or Dialysis)|Number of subjects that require renal (kidney) replacement therapy, such as a kidney transplant or dialysis within 30 days of study participation.|30 days|||Participants|||Count of Participants
637855|NCT02469298|Primary|Change From Baseline in Clinical Chemistry Parameters- Albumin and Total Protein|Clinical chemistry parameters included Albumin and Total protein. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.|Baseline (Day 1) and up to Day 28/withdrawal|Safety population. Only those participants available at the specified time points were analyzed.||Grams per Litre (G/L)||Standard Deviation|Mean
637856|NCT02469298|Primary|Change From Baseline in Hematology Parameters- Red Blood Cell (RBC) Count and Reticulocytes Count|Hematology parameters included RBC count and Reticulocytes count. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.|Baseline (Day 1) and up to Day 28/withdrawal|Safety population. Only those participants available at the specified time points were analyzed.||Trillion cells per Liter (TI/L)||Standard Deviation|Mean
637857|NCT02469298|Primary|Change From Baseline in Hematology Parameters- Mean Corpuscle Volume (MCV)|Hematology parameters included Mean corpuscle volume (MCV). Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.|Baseline (Day 1) and up to Day 28/withdrawal|Safety population. Only those participants available at the specified time points were analyzed.||Femtoliters (FL)||Standard Deviation|Mean
637858|NCT02469298|Primary|Change From Baseline in Hematology Parameters- Mean Corpuscle Hemoglobin (MCH)|Hematology parameters included Mean corpuscle hemoglobin (MCH). Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.|Baseline (Day 1) and up to Day 28/withdrawal|Safety population. Only those participants available at the specified time points were analyzed.||Picogram (PG)||Standard Deviation|Mean
637859|NCT02469298|Primary|Change From Baseline in Hematology Parameters- Hematocrit|Hematology parameters included Hematocrit. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.|Baseline (Day 1) and up to Day 28/withdrawal|Safety population. Only those participants available at the specified time points were analyzed.||Fraction||Standard Deviation|Mean
637860|NCT02469298|Primary|Change From Baseline in Hematology Parameters- Hemoglobin|Hematology parameters included Hemoglobin. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.|Baseline (Day 1) and up to Day 28/withdrawal|Safety population. Only those participants available at the specified time points were analyzed.||Grams per Litre (G/L)||Standard Deviation|Mean
637861|NCT02469298|Primary|Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count|Hematology parameters included Basophils, Eosinophils, Lymphocytes, Monocytes, Total neutrophils (Total ANC), Platelet count and WBC count. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.|Baseline (Day 1) and up to Day 28/withdrawal|Safety population. Only those participants available at the specified time points were analyzed.||Giga cells per litre (GI/L)||Standard Deviation|Mean
637862|NCT02469298|Primary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant.|Up to Day 28/withdrawal|Safety population comprised of all randomized participants who received at least one dose of investigational product (IP).||Participants|||Count of Participants
637863|NCT02469116|Other Pre-specified|Adverse Events as Measured by Number of Events Experienced by All Participants||30 days after completion of treatment (approximately 22 weeks)|||events|||Number
637864|NCT02469116|Secondary|Quality of Life (QoL) as Measured by FACT-O Assessment Tool|"The FACT-O questionnaire consists of a Physical Well-Being Section, Social/Family Well-Being Section, Emotional Well-Being Section, Functional Well-Being Section, and Additional Concerns Section
Answers range from Not at all to Very Much with 0 = not at all and 4 = very much"|Completion of follow-up|The sponsor withdrew funding for the study which meant there was no funding for completion of accrual, follow-up or statistical analysis.|||||
637865|NCT02469116|Secondary|Progression-free Survival (PFS)|-Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.|Completion of follow-up|The sponsor withdrew funding for the study which meant there was no funding for completion of accrual, follow-up or statistical analysis.|||||
637866|NCT02469116|Secondary|Overall Survival (OS)|Overall Survival is the observed length of life from entry into the study to death or the date of last contact|Completion of follow-up|The sponsor withdrew funding for the study which meant there was no funding for completion of accrual, follow-up or statistical analysis.|||||
637867|NCT02469116|Secondary|Time to Progression (TTP)|Progressive disease is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry. Unequivocal progression of existing non-target lesions, other than pleural effusions without cytological proof of neoplastic origin, in the opinion of the treating physician within 8 weeks of study entry is also considered increasing disease (in this circumstance an explanation must be provided). In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% increase in the LD is required.|Completion of follow-up|The sponsor withdrew funding for the study which meant there was no funding for completion of accrual, follow-up or statistical analysis.|||||
643873|NCT02226198|Secondary|Urinalysis Abnormalitites|Safety and tolerability will be described in terms of abnormal urine laboratory values|Week 0, week 6, week 12 and week 18|||participants|||Number
637868|NCT02469116|Secondary|Efficacy of Regimen as Measured by CA-125 Response|"Progression is defined as one of the following:
Patients with elevated CA-125 pretreatment and normalization of CA-125 must show evidence of CA-125 ≥ twice the upper limit of normal on two occasions at least one week apart
Patients with elevated CA-125 pretreatment which never normalizes must show evidence of CA-125 ≥ 2 times the nadir value OR > 50% increase from the nadir on two occasions at least one week apart,
Patients with CA-125 in the normal range pretreatment must show evidence of CA-125 ≥ two times the upper limit of normal on two occasions at least one week apart.
Complete response is defined as a CA-125 value <13 confirmed on two occasions at least 2 weeks apart.
Partial Response is defined as a reduction of at least 50% from the original elevated CA-125 value (original value must have been > 50), confirmed on two occasions at least 2 weeks apart.
Stable Disease is defined as not meeting one of the above criteria."|Completion of treatment (approximately 18 weeks)|||participants|||Number
637869|NCT02469116|Primary|Incidence of Grade 3-4 Neutropenia as Measured by CTCAE Version 3||Through 30 days after completion of treatment (approximately 22 weeks)|||participants|||Number
637870|NCT02468414|Primary|Patients Who Achieved Biological Activity of MDGN201 TARGTEPO Secretion as Measured by Serum EPO Levels Above Baseline.||52 weeks|No statistical analysis was performed as only one subject was treated with MDGN201 TARGTEPO due to the Sponsor's decision to discontinue study.||Participants|||Count of Participants
637871|NCT02468154|Secondary|Comfort Perceived by the Patient and by the Caregiver Using a Scale of 0 to 10|The scales had values from 0 to 10 where zero represented no comfort perceived and 10 the best comfort perceived|one time at cast removal (expected average of 30 days).|||units on a scale||Standard Deviation|Mean
637872|NCT02468154|Secondary|Health Staff/Caregiver Interventions|daily number of interventions by health staff /caregiver to maintain the cast in an off-loaded position, marked on a form given daily to the family/caregiver|up to the first 2 days during hospitalization|||daily number of interventions||Standard Deviation|Mean
637873|NCT02468154|Secondary|Numbers of Participants With Heel Pressure Sores Detected According to the Classification of the Scale of the National Pressure Ulcer Advisory Panel –N.P.U.A.P.||one time at cast removal (expected average of 30 days).|||participants|||Number
637874|NCT02468154|Primary|"Pain Score on the Numeric Rating Scale or Visual Rating Scale or Face, Legs Activity Cry Consolability According to Age Group"|All scales had values from 0 to 10 where zero represented no pain and 10 the worst possible pain|up to the first 2 days during hospitalization and at cast removal (maximum 30 days).|||units on a scale||Standard Deviation|Mean
637875|NCT02467777|Primary|Temperature|Measured by temporal artery thermometer|Intra-Operative|||degrees celsius||Standard Deviation|Mean
637876|NCT02467491|Secondary|Change From 4 Weeks (End of Intervention) to 3 Months After the End of the Intervention in the Short Physical Performance Battery Test|Physical performance will be assessed using the Short Physical Performance Battery test (SPPB). The score for this test is 0 meaning the worst performance to 12 meaning the best performance.|Change in 4 weeks to 3 months|||units on a scale||Standard Deviation|Mean
637877|NCT02467491|Secondary|Change From Baseline to 4 Weeks in the Short Physical Performance Battery Test|Physical performance will be assessed using the Short Physical Performance Battery test (SPPB). The score for this test is 0 meaning the worst performance to 12 meaning the best performance.|Change in baseline to 4 weeks|||units on a scale||Standard Deviation|Mean
637878|NCT02467491|Primary|Global Appreciation Score|"The global appreciation score is a measure of feasibility.
This score will be derived from each participant's answer to the first question of a 9-item acceptability questionnaire. The second question of the questionnaire is :How much did you like Jintronix?, participants' answer may be:
I didn't like it (0 point)
A little (1 points)
Moderate (2 points)
A lot (3 points). The global appreciation score is the sum of the points obtained by each participants.
The global appreciation score for 12 participants may range from 0 (no appreciation) to 36 (a lot of appreciation).
In order to say that Jintronix is feasible we expected a global appreciation score for 12 participant after 4 weeks of intervention to be > 24."|4 weeks|||units on a scale|||Number
637879|NCT02467491|Primary|Global Difficulty Score|"The global difficulty score was another measure of acceptability.
The global difficulty score will be derived from each participant's answer to the second question of a 9-item feasibility questionnaire. The second question of the questionnaire is :How difficult did you find the Jintronix?, participants' answer may be:
Very difficult (3 point)
Quite difficult (2 points)
Not at all (1 points)
No difficulty (0 points). This means that the global difficulty score for 12 participants may range from 0 (no difficult) to 36 (very difficult).
We expected to find a global difficulty score < to 15 in order to say that Jintronix was acceptable."|4 weeks|||units on a scale|||Number
637880|NCT02467491|Primary|Total Average Time in Performing Exercises With Jintronix.|"Each participant has to perform the exercise program with Jintronix for 30 minutes per session, for 2 times/week for a total of 4 weeks.
This means that each participant has to be able to perform a maximum of 240 minutes of exercises for 4 weeks.
Jintronix calculated automatically the time (minutes) in performing the exercises for each participant at the end of the 4 weeks of intervention.
As a measure of acceptability we calculated the total average time in performing the exercises for the 12 participants for 4 weeks by summing the minutes in performing the exercises for each participants for 4 week and dividing it for 12.
We expected to find an average total time in performing the exercises for 12 participants > 192 minutes (3.2 hours) out of a total of 240 minutes (4 hours) in order to say that Jintronix was acceptable."|4 weeks|||minutes||Standard Deviation|Mean
637881|NCT02467491|Primary|Quality of Movements' Total Average Score|"The quality of movements’ score is a measure of feasibility. The quality of movement's score is automatically calculated by Jintronix for each participant at the end of the intervention program with Jintronix.
A quality of movement's score of 100% means that the participant performed the exercise perfectly.
To calculate the quality of movements' total average score for the Group (made of 12 participants), we summed the quality of movements' score for each participants and divided it for 12. We expected to find a total average quality movements' score>80% in order to say that Jintronix was feasible."|4 weeks|||percentage of quality of movements||Standard Deviation|Mean
637882|NCT02467075|Secondary|Mortality Rate - 30 Day|Number of subjects who died within 30 days of entry into the study.|30 days|||participants|||Number
637883|NCT02467075|Secondary|30-day Readmission|Number of times a subject is readmitted within 30 days of study recruitment|30 days|||Number of admissions||Standard Deviation|Mean
654913|NCT01958346|Primary|Number of Participants With Successful Intubations on First Attempt; Grade(s) Were Not Measured.||At Intubation|||participants|||Number
637887|NCT02467075|Primary|Participants With Stage II AKI (Acute Kidney Injury)|Participants who had Stage II AKI. This is measured by comparing an initial blood creatinine level with the level at 48 hours. Creatine is a chemical waste product that passes through the kidneys. Creatinine levels reflect how well the kidneys are working.|48 hours|Participants with State II AKI (Acute Kidney Injury)||Participants|||Count of Participants
637888|NCT02466425|Secondary|Clinical Global Impression of Improvement (CGI-I) at Visit 6 (Week 4)|CGI-I was performed to rate the severity of a participant's condition on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).|Visit 6 (Week 4)|FAS with number of participants evaluable for this outcome.||Units on a scale||Standard Deviation|Mean
637889|NCT02466425|Primary|Change From Baseline in Attention-Deficit Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) Total Score at Visit 6 (Week 4)|The ADHD-RS-IV consists of 18 items designed to reflect current symptomatology of ADHD based on diagnostic and statistical manual of mental disorders, fourth edition - text revision (DSM-IV-TR) criteria. Each item is scored on a 4-point scale ranging from 0 (reflecting no symptoms) to 3 (reflecting severe symptoms) with total scores ranging from 0-54. The 18 items may be grouped into 2 subscales: hyperactivity/impulsivity (even-numbered items 2-18) and inattentiveness (odd-numbered items 1-17). Higher score = more severe symptoms.|Baseline, Visit 6 (Week 4)|Full-analysis set (FAS) consisted of the safety set who had at least 1 post-dose ADHD-RS-IV total score assessment. FAS with number of participants evaluable for this outcome.||Units on a scale||Standard Deviation|Mean
637890|NCT02466412|Primary|Area Under the Plasma Concentration Versus Time Curve From Time Zero (Pre-product Use) to Last Time Point [AUC(0-last)] Following Single Use of CHTP 1.1 M and mCC|"T0 = start of single product use.
Derived from multiple blood sampling on Day 1 and Day 3 (1 blood sampling pre-product use and multiple blood sampling over 24 hours post-product use).
Geometric Least Squares means are provided."|Day 3: blood taken 15 minutes prior to T0, 2, 4, 6, 8, 10, 15, 30, 45 minutes, 1, 2, 4, 6, 9, 12, and 24 hours after T0.|"The PK population consisted of 47 subjects.
1 subject was excluded from the PK population (sequence CHTP 1.1 M then mCC) due to all plasma nicotine concentration measurements being below the quantification limit for both CHTP 1.1 M and mCC."||h*ng/mL||95% Confidence Interval|Least Squares Mean
637891|NCT02466412|Primary|Maximum Concentration (Cmax) of Nicotine Following Single Use of CHTP 1.1 M and mCC|"T0 = start of single product use.
Derived from multiple blood sampling on Day 1 and Day 3 (1 blood sampling pre-product use and multiple blood sampling over 24 hours post-product use).
Geometric Least Squares (LS) means are provided."|Day 3: blood taken 15 minutes prior to T0, 2, 4, 6, 8, 10, 15, 30, 45 minutes, 1, 2, 4, 6, 9, 12, and 24 hours after T0.|"The PK population consisted of 47 subjects.
1 subject was excluded from the PK population (sequence CHTP 1.1 M then mCC) due to all plasma nicotine concentration measurements being below the quantification limit for both CHTP 1.1 M and mCC."||ng/mL||95% Confidence Interval|Least Squares Mean
637892|NCT02465866|Primary|Percentage of AUCinf [AUCExtrap (%)] Based on Extrapolation|"Calculated as:
AUCExtrap (%) = (AUC0-inf - AUC0-last)/AUC0-inf *100"|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose|ITT population||Percentage of AUCExtrap||Standard Deviation|Mean
637893|NCT02465866|Primary|Area Under the Concentration-time (AUCinf) Curve From Time-zero Extrapolated to Infinity|"Calculated as:
AUCinf = AUClast + Clast/λz"|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose|ITT population||h*ng/mL||Standard Deviation|Mean
637894|NCT02465866|Primary|Area Under the Plasma Concentration-time (AUClast) Curve From Time-zero to the Time of the Last Quantifiable Concentration|Calculated using the linear trapezoidal rule|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose|ITT population||h*ng/mL||Standard Deviation|Mean
637895|NCT02465866|Primary|AUC0-4.0 for Hydrocodone and Promethazine|AUC0-4.0 measured by Linear Trapezoidal with Linear Interpolation method.|0 (pre-dose) to 4 hours post-dose|ITT population||h*ng/mL||Standard Deviation|Mean
637896|NCT02465866|Primary|AUC0-2.0 for Hydrocodone and Promethazine|AUC0-2.0 measured by Linear Trapezoidal with Linear Interpolation method.|0 (pre-dose) to 2 hours post-dose|ITT population||h*ng/mL||Standard Deviation|Mean
637897|NCT02465866|Primary|AUC0-1.5 for Hydrocodone and Promethazine|AUC0-1.5 measured by Linear Trapezoidal with Linear Interpolation method.|0 (pre-dose) to 1.5 hours post-dose|ITT population||h*ng/mL||Standard Deviation|Mean
637898|NCT02465866|Primary|AUC0-1.0 for Hydrocodone and Promethazine|AUC0-1.0 measured by Linear Trapezoidal with Linear Interpolation method.|0 (pre-dose) to 1.0 hours post-dose|ITT population||h*ng/mL||Standard Deviation|Mean
637899|NCT02465866|Primary|AUC0-0.75 for Hydrocodone and Promethazine|AUC0-0.75 measured by Linear Trapezoidal with Linear Interpolation method.|0 (Pre-dose) to 0.75 hours post-dose|ITT population||h*ng/mL||Standard Deviation|Mean
637900|NCT02465866|Primary|AUC0-0.50 for Hydrocodone and Promethazine|AUC0-0.50 measured by Linear Trapezoidal with Linear Interpolation method.|0 (pre-dose) to 0.5 hours post-dose|ITT population||h*ng/mL||Standard Deviation|Mean
637901|NCT02465866|Primary|Area Under the Plasma Concentration-time Curve (AUC0-0.25) for Hydrocodone and Promethazine|AUC0-0.25 measured by Linear Trapezoidal with Linear Interpolation method.|0 (pre-dose) to 0.25 hours post-dose|ITT population||h*ng/mL||Standard Deviation|Mean
637902|NCT02465866|Primary|Observed Terminal Elimination Half-life (T1/2)|Calculated as: T1/2 = ln(2)/λz|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose|ITT population||hours||Standard Deviation|Mean
637903|NCT02465866|Primary|Observed Elimination Rate Constant (λz)|Estimated by linear regression through at least three data points in the terminal phase of the log concentration-time profile|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose|ITT population||h-1||Standard Deviation|Mean
637904|NCT02465866|Primary|Time of the Last Quantifiable Concentration (Tlast)||0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose|ITT population||Hours||Standard Deviation|Mean
637905|NCT02465866|Primary|Last Quantifiable Drug Concentration (Clast) Determined Directly From Individual Concentration-time Data||0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose|ITT population||ng/mL||Standard Deviation|Mean
637906|NCT02465866|Primary|Time to Reach Maximum Concentration (Tmax)||0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose|ITT population||hours||Standard Deviation|Mean
638049|NCT02454127|Secondary|Glucose|Change from baseline glucose at 1 year, measured in mg/dL|1 year|Intent-to-treat analysis. Missing data were replaced with baseline values.||mg/dL||Standard Deviation|Mean
637907|NCT02465866|Primary|Maximum Drug Concentration (Cmax) in Plasma Determined Directly From Individual Concentration-time Data|Cmax of CL-108 and Vicoprofen + Ultracet + Phenergan were measured in the plasma (the liquid component of the blood in which the blood cells are suspended) in samples collected up to 48 hours post-dose.|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose|Intended to treat (ITT) population||ng/mL||Standard Deviation|Mean
637908|NCT02465632|Primary|Mean Percent Change in the Number of Non-inflamed Lesions (Open and Closed Comedones)|The number of non-inflamed lesions (open and closed comedones) count between treatment groups were estimated.|Baseline and 10 Weeks|||Percentage change from baseline||Standard Deviation|Mean
637909|NCT02465632|Primary|Mean Percent Change in the Number of Inflamed Lesions (Papules/Pustules)|The number of inflammatory lesions (papules and pustules) count between the treatment groups were estimated.|Baseline and 10 Weeks|||percentage change from baseline||Standard Deviation|Mean
637910|NCT02465489|Secondary|Number of Subjects With Adverse Events (AEs)|Number of subjects with AEs. AEs will include clinically significant changes from baseline in vital signs, 12-lead ECG, physical examinations, and laboratory tests.|Throughout the trial, from the time of the first dose until the last study visit (Day 36 or early termination)|The safety population included all subjects who received at least one of the investigational products under study||participants|||Number
637911|NCT02465489|Primary|AUC0-∞for Serum Deferiprone|Area under the serum concentration time curve extrapolated to infinity. Blood samples will be collected pre-dose and over a 24-hour interval post-dose.|Samples were collected pre-dose and at 0.25, 0.5, 0.75, 1.0, 1.33, 1.66, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 8.0, 12.0, 16.0, and 24.0 hours post-dose.|The pharmacokinetic population included subjects who provided evaluable data for at least two study periods||ug*h/mL||Standard Deviation|Mean
637912|NCT02465489|Primary|Tmax for Serum Deferiprone|Time of maximum observed serum concentration. Blood samples will be collected pre-dose and over a 24-hour interval post-dose|Samples were collected pre-dose and at 0.25, 0.5, 0.75, 1.0, 1.33, 1.66, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 8.0, 12.0, 16.0, and 24.0 hours post-dose.|The pharmacokinetic population included subjects who provided evaluable data for at least two study periods||Hour||Standard Deviation|Mean
637913|NCT02465489|Primary|Cmax for Serum Deferiprone|Maximum measured serum concentration. Blood samples will be collected pre-dose and over a 24-hour interval post-dose|Samples were collected pre-dose and at 0.25, 0.5, 0.75, 1.0, 1.33, 1.66, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 8.0, 12.0, 16.0, and 24.0 hours post-dose.|The pharmacokinetic population included subjects who provided evaluable data for at least two study periods.||μg/mL||Standard Deviation|Mean
637914|NCT02465073|Primary|The Percentage of Patients Who Had a 50% or Greater Wound Size Volume Reduction After 4 Weeks of Treatment With the Next Science Wound Gel, as Compared to Wounds Treated With Standard of Care||Percentage after 4 weeks|||percentage of participants|||Number
637915|NCT02463409|Secondary|Change in Apnea Hypopnea Index (AHI)|Change in AHI before and during treatment with theophylline|1 day|||units on a scale||Standard Error|Mean
637916|NCT02463409|Secondary|Change in Resting Energy Expenditure (REE)|Change in REE before and during treatment with theophylline|1 day|||kcals per day||Standard Error|Mean
637917|NCT02463409|Primary|Change in Urine cAMP|Change in urine cAMP (after parathyroid hormone stimulation) before and during treatment with theophylline|1 day|Patients treated with theophylline who maintained appropriate IV access. Only 3 patients had complete data available.||fm/uL||Standard Deviation|Mean
637918|NCT02463331|Secondary|Histopathological Response to Therapy|Histopathological response is achieved when there is minimal or no inflammation in hepatic tissue, as assessed by liver biopsy.|liver biopsy was was performed to evaluate histopathological response after 18 months of biochemical response|The histological response was only evaluated in the patients with biochemical remission, since in the patients without biochemical response it was already known that there would be activity in the liver tissue.||Participants|||Count of Participants
637919|NCT02463331|Primary|Biochemical Response to Therapy|The biochemical response is defined when there is normalization of hepatic enzymes, mainly AST and ALT.|six months|||Participants|||Count of Participants
637920|NCT02463227|Secondary|Percentage of Participants Who Had a Confirmed HIV-1 RNA Greater Than or Equal to 200 Copies/mL at Week 4 of the ATI or Indication to Reinitiate ART Prior to Week 4 of the ATI|The secondary efficacy outcome was the percentage of participants who had a confirmed HIV-1 RNA greater than or equal to 200 copies/mL at week 4 of the ATI or indication to reinitiate ART prior to week 4 of the ATI.|Measured at weeks 1, 2, 3, and 4 of the ATI|Per protocol, the analysis population was limited to participants who received all scheduled VRC01 infusions and underwent an ATI according to protocol.||percentage of participants||90% Confidence Interval|Number
637921|NCT02463227|Secondary|Measured Values of VRC01 in Plasma in the First 8 Weeks of the Analytical Treatment Interruption (ATI)|Measured values of plasma VRC01, measured in micrograms per milliliter, through week 8 of the ATI. The median and range of all VRC01 measurements taken in the first 8 weeks of the ATI were reported.|Measured at weeks 1, 2, 3, 4, 5, 6, 7, and 8 of the ATI|Per protocol, the analysis population was limited to participants who received all scheduled VRC01 infusions and underwent an ATI according to protocol.||micrograms/mL||Full Range|Median
637922|NCT02463227|Secondary|Measured Value of Plasma VRC01 at the Time of Rebound|Measured value of plasma VRC01, measured in micrograms per milliliter, at the time of rebound. Rebound is defined as the point in time when plasma HIV-1 RNA surpassed 40 copies/mL.|Measured from entry through week 21 (Steps 1 and 2)|Per protocol, the analysis population was limited to participants who received all scheduled VRC01 infusions and underwent an ATI according to protocol.||micrograms/mL||Full Range|Median
637923|NCT02463227|Primary|Percentage of Participants Who Had a Confirmed HIV-1 RNA Greater Than or Equal to 200 Copies/mL at Week 8 of the Analytical Treatment Interruption (ATI) or Indication to Re-initiate ART Prior to Week 8 of the ATI|The primary efficacy outcome is the percentage of participants who had a confirmed HIV-1 RNA greater than or equal to 200 copies/mL at week 8 of the analytical treatment interruption (ATI) or indication to re-initiate ART prior to week 8 of the ATI.|Measured at Weeks 1, 2, 3, 4, 5, 6, 7, and 8 of the ATI|Per protocol, the analysis population was limited to participants who received all scheduled VRC01 infusions and underwent an ATI according to protocol.||percentage of participants||90% Confidence Interval|Number
638050|NCT02454127|Secondary|Triglycerides|Change from baseline triglycerides at 1 year, measured in mg/dL|1 year|Intent-to-treat analysis. Missing data were replaced with baseline values||mg/dL||Standard Deviation|Mean
637924|NCT02463227|Primary|Percentage of Participants Who Experienced a Grade 3 or Higher Systemic (i.e., Not a Local Reaction) Adverse Event (AE) That is Possibly, Probably, or Definitely Related to the Administration of the VRC01 Antibody|The primary safety outcome examined the occurrence of a Grade 3 or higher systemic (i.e., not a local reaction) adverse event (AE) possibly, probably, or definitely related to the administration of the VRC01 antibody. The DAIDS AE Grading Table (V2.0) was used.|Measured from entry through week 21 (Steps 1 and 2)|All participants exposed to study treatment (VRC01) were included.||percentage of participants||95% Confidence Interval|Number
637925|NCT02463097|Secondary|Number of Diabetic Ketoacidosis (DKA) Events|There is no statistically powered secondary endpoint in this study. However, there will be a descriptive analysis on number of Diabetic Ketoacidosis (DKA) Event.|3 months|||events|||Number
637926|NCT02463097|Secondary|Number of Severe Hypoglycemia Events|There is no statistically powered secondary endpoint in this study. However, there will be a descriptive analysis of the number of Severe Hypoglycemia events.|3 months|||events|||Number
637927|NCT02463097|Primary|Change in A1C|There is no statistically powered primary endpoint in this study. However, there will be a descriptive analysis of change in A1C.|Baseline and 3 months|||Percent||Standard Deviation|Mean
637928|NCT02462473|Secondary|Patient Satisfaction Survey (PSS) Total Score at Week 0 and 12|The PSS is a brief scale designed to capture a psychiatric patient’s satisfaction with a clinician. The scale covers 6 domains: Trust (3 items), Communication (3 items), Exploration of Ideas/Options (2 items), Body Language (2 items), Active Listening (4 items), and Miscellaneous Items (6 items). Out of the 20 items, the first 19 are scored on a 5-point Likert Scale (1=strongly disagree, 2=disagree, 3=satisfactory, 4=agree, 5=strongly agree). The last question (6f) is a free-response question asking for input on how the clinician might improve. Sum of scores of individual items give a total score (range 9-95). Higher scores indicate greater degree of satisfaction. Due to early study termination collected data was not summarized. Hence, individual data for each participant was reported.|Week 0, Week 12|All enrolled participants who had a baseline CASP evaluation were included in the efficacy analysis set. One participant (Participant 4) was not analyzed at Week 12 due to discontinuation caused by death.||units on a scale|||Number
637929|NCT02462473|Secondary|Adherence to Antipsychotic Medication as Assessed by Brief Adherence Rating Scale (BARS) at Week 0 and 12|The BARS is a 4-item scale that includes 3 questions and an overall visual analog rating scale that assesses participant’s knowledge about his/her medication. The key measure of adherence is the visual analog scale and assesses the percentage of doses taken by the participants in the past month (0 percent [%] - 100%). The 3 questions include: number of prescribed doses per day, number of days in the past month when the participant did not take the prescribed doses, and the number of days in the past month when the participant took less than the prescribed dose. Due to early study termination collected data was not summarized. Hence, individual data for each participant was reported.|Week 0, Week 12|All enrolled participants who had a baseline CASP evaluation were included in the efficacy analysis set. One participant (Participant 4) was not analyzed at Week 12 due to discontinuation caused by death.||percent adherence|||Number
637930|NCT02462473|Secondary|Clinician’s Rating Scale of Adherence (CRS) Score at Week 0 and 12|The CRS is an ordinal scale filled by the clinician. The scores range from 1 to 7 that were used to quantify the clinician’s assessment of treatment adherence by the patient. Higher scores indicate greater adherence. Due to early study termination collected data was not summarized. Hence, individual data for each participant was reported.|Week 0, Week 12|All enrolled participants who had a baseline CASP evaluation were included in the efficacy analysis set. One participant (Participant 4) was not analyzed at Week 12 due to discontinuation caused by death.||units on a scale|||Number
637931|NCT02462473|Secondary|Number of Participants With Factors Considered in Clinical Decision as Assessed by Clinical Assessment of the Schizophrenia Patient (CASP)|The CASP and data on concomitant medications and psychosocial treatments were used to evaluate the impact of AMPL results on other aspects of clinical decision making.|Up to Week 12|All enrolled participants who had a baseline CASP evaluation were included in the efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this endpoint.||participants|||Number
637932|NCT02462473|Secondary|Antipsychotic Medication Plasma Levels (AMPL) During the Active Assessment Phase at Week 12|AMPL of the individual participant during the active assessment phase was reported.|Week 12|AMPL analysis set included all enrolled participants who had AMPL data for at least 1 visit. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this endpoint.||nanogram per milliliter|||Number
637933|NCT02462473|Secondary|Dimensions of Psychosis Symptom Severity Scale (DPSS) Total Score at Week 0 and 12|The DPSS is a clinician-rated scale used to rate 8 domains commonly seen in patients with psychotic disorders. Each domain was rated on a 5-point scale (0 to 4) with anchored description of endpoints. Total score was computed by summing the scores of individual items (range of 0–32). Higher scores represent more severe condition. Due to early study termination collected data was not summarized. Hence, individual data for each participant was reported.|Week 0, Week 12|All enrolled participants who had a baseline CASP evaluation were included in the efficacy analysis set. One participant (Participant 4) was not analyzed at Week 12 due to discontinuation caused by death.||units on a scale|||Number
637934|NCT02462473|Secondary|Clinical Global Impression-Severity (CGI-S) Score at Week 0 and 12|Clinical Global Impression-Severity (CGI-S) rating scale used to rate the severity of a participant's overall clinical condition on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe). Due to early study termination collected data was not summarized. Hence, individual data for each participant was reported.|Week 0, Week 12|All enrolled participants who had a baseline CASP evaluation were included in the efficacy analysis set. One participant (Participant 4) was not analyzed at Week 12 due to discontinuation caused by death.||units on a scale|||Number
637999|NCT02457728|Primary|Number of Participants With Safe Fixation of Mesh and Closure of Peritoneum by Clinical Investigation During Hospital Stay and Telephone Interview at Six Weeks Postoperatively.|Clinical examination during hospital stay to rule out any bowel obstruction due to insufficient closure of peritoneum. Telephone interview at six weeks postoperatively to record any adverse events in the early postoperative period such as recurrent hernia, pain or bowel obstruction.|During hospitalization and 6 weeks after surgery.|||participants|||Number
638051|NCT02454127|Secondary|HDL Cholesterol|Change from baseline HDL cholesterol at 1 year, measured in mg/dL|1 year|Intent-to-treat analysis. Missing data were replaced with baseline values.||mg/dL||Standard Deviation|Mean
637935|NCT02462473|Primary|Number of Participants With Medication Treatment Modifications (MTM)|Information on MTMs derived from data collected in the clinical assessment of the schizophrenia patient (CASP) questionnaire. The CASP captured changes in medications, changes in psychosocial treatments, visit frequency, and the need for any acute interventions. The CASP comprised of 3 sections covering several parameters. The CASP captured changes in treatment options which was used to compute MTM, as well as factors in clinical decision making and the influence of antipsychotic medication plasma levels (AMPL), when they were available, on clinical decision making.|Up to Week 12|All enrolled participants who had a baseline CASP evaluation were included in the efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this endpoint.||Participants|||Number
637936|NCT02462291|Secondary|Number of Patients Treated With Ticlopidin||PRE and POST 6 months of treatment|||Participants|||Number
637937|NCT02462291|Secondary|Number of Patients Treated With Memantine||PRE and POST 6 months of treatment|||Participants|||Number
637938|NCT02462291|Secondary|Number of Patients Treated With Donepezil||PRE and POST 6 months of treatment|||Participants|||Number
637939|NCT02462291|Secondary|Number of Patients Treated With Citalopram||PRE and POST 6 months of treatment|||Participants|||Number
637940|NCT02462291|Secondary|Number of Patients Treated With Quetiapine||PRE and POST 6 months of treatment|||Participants|||Number
637941|NCT02462291|Secondary|Number of Medications||PRE and POST 6 months of treatment|||Number of Medications||Standard Deviation|Mean
637942|NCT02462291|Secondary|Salivary Cortisol (Nmol/l)|Levels of cortisol was measured via saliva samples using plain Sarstedt Salivette collection devices (Nümbrecht, Germany). Samples will be collected at 6.30 AM, 11.30 AM, and 6.30 PM. Immediately after collecting the saliva samples, were centrifuged for 2 min at 1,000 rpm. Purified saliva was stored in a freezer at -20 °C, and subsequently analyzed. Cortisol levels was determined by a time-resolved immunoassay with fluorometric detection.|PRE and POST 6 months of treatment|||(nmol/L)||Standard Deviation|Mean
637943|NCT02462291|Secondary|Evaluation of Activity of Daily Life|Independence and level of activities of daily life (ADL) were evaluated with the Barthel index. Levels of ADL was measured by observing each resident’s daily activities (eating, bathing, grooming, dressing, transfers from bed to chair, mobility on level planes, stairs, and getting on/off the toilet). The total score of the Barthel index is 0-100, and higher values represent a better outcome.|PRE and POST 6 months of treatment|||Scores on a scale||Standard Deviation|Mean
637944|NCT02462291|Secondary|Daily Energy Expenditure (Kcal/Day)|Daily energy expenditure was measured with an Actiheart device (CamNtech, Cambridge, UK) allowing heart rate and acceleration data to be simultaneously recorded for 24 h/day for 7 consecutive days.|PRE and POST 6 months of treatment|||(Kcal/day)||Standard Deviation|Mean
637945|NCT02462291|Secondary|Blood Cholesterol LDL (mg/dl)|A fasted venous blood sample was analyzed for low-density lipoprotein blood levels by standard techniques.|PRE and POST 6 months of treatment|||(mg/dl)||Standard Deviation|Mean
637946|NCT02462291|Secondary|Blood Cholesterol HDL (mg/dl)|A fasted venous blood sample was analyzed for high-density lipoprotein blood levels by standard techniques.|PRE and POST 6 months of treatment|||(mg/dl)||Standard Deviation|Mean
637947|NCT02462291|Secondary|Blood Glucose (mg/dl)|A fasted venous blood sample will be analyzed for glucose blood levels by standard techniques.|PRE and POST 6 months of treatment|||(mg/dl)||Standard Deviation|Mean
637948|NCT02462291|Secondary|Diastolic Blood Pressure (mmHg)|Diastolic blood pressure were measured with standard auscultatory and mercury sphygmomanometer technique.|PRE and POST 6 months of treatment|||(mmHg)||Standard Deviation|Mean
637949|NCT02462291|Secondary|Systolic Blood Pressure (mmHg)|Systolic blood pressure were measured with standard auscultatory and mercury sphygmomanometer technique.|PRE and POST 6 months of treatment|||(mmHg)||Standard Deviation|Mean
637950|NCT02462291|Secondary|Body Composition (Kilograms of Fat Free Mass)|Body mass and skin-fold measurements were measured three times a day by the same experienced operator. The average value of the three measurements was calculated. Kilograms of fat free mass was estimated using a validated equation.|PRE and POST 6 months of treatment|||kg||Standard Deviation|Mean
637951|NCT02462291|Primary|Evaluation of Cognitive Status (Score 0-30)|Through the use of Mini Mental State Examination (MMSE) the investigators estimated the severity and progression of cognitive impairment. MMSE is a questionnaire that examines cognitive functions including registration, attention, calculation, recall, language, ability to follow simple commands and orientation. The scale range of the MMSE tests is 0-30, and higher values represent a better outcome.|PRE and POST 6 months of treatment|||Scores on a scale||Standard Deviation|Mean
637952|NCT02462291|Primary|Evaluations of Behavioral Disorders|Through the use of Neuropsychiatric Inventory (NPI), the investigators assessed the frequency and the severity of the behavioral disorders. The total scale range of the NPI is 0-144, and higher values represent worse outcome.|PRE and POST 6 months of treatment|||Scores on a scale||Standard Deviation|Mean
637953|NCT02461992|Other Pre-specified|Number of Participants With Positive FVIII Inhibitor Activity at Day 4|As with all FVIII products, participants using Xyntha were monitored for the development of FVIII inhibitors. Values >= 0.6 Bethesda Unit (BU) per mL were considered positive results.|Day 4|The safety analysis population included all participants who received at least 1 dose of study drug.||participants|||Number
637954|NCT02461992|Other Pre-specified|Number of Participants With Potentially Clinically Significant Vital Signs Findings|Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: supine pulse rate <50 beats per minute (bpm), >=30 bpm increase from baseline, or >25 bpm decrease from baseline; systolic blood pressure (SBP) <90 milliliters of mercury (mmHg), >=30 mmHg increase from baseline, or >=30 mmHg decrease from baseline; diastolic blood pressure (DBP) <50 mmHg, >=20 mmHg increase from baseline, or >=20 mmHg decrease from baseline.|Baseline up to Day 4|The safety analysis population included all participants who received at least 1 dose of study drug.||participants|||Number
638000|NCT02457611|Secondary|Percent Change From Baseline in CD4 T-cell Count at the End of Treatment and at Posttreatment Week 4||Baseline; Week 6; Posttreatment Week 4|Participants in the Safety Analysis Set with available data were analyzed.||percent change||Standard Deviation|Mean
638001|NCT02457611|Secondary|Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL While on HCV Treatment and at Posttreatment Week 4||Weeks 2, 4, 6, and Posttreatment Week 4|Participants in the Safety Analysis Set who had HIV-1 RNA < 50 copies/mL at Baseline were analyzed.||percentage of participants||95% Confidence Interval|Number
637955|NCT02461992|Other Pre-specified|Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern|The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell count, RBC morphology, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen, creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin, and total protein; urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, microscopy [if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase]); others (urine drug screening, FVIII inhibitor assay, FVIII activity, prothrombin time [PT], activated partial thromboplastin time [APTT], anti-human immunodeficiency virus [HIV] 1, hepatitis C virus antibody [HCVAb], HAVAb, HBsAg, HBsAb, HBcAb). Only parameters which met abnormality criteria are reported.|Baseline up to Day 4|The safety analysis population included all participants who received at least 1 dose of study drug.||participants|||Number
637956|NCT02461992|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.|Baseline up to Day 28|The safety analysis population included all participants who received at least 1 dose of study drug.||participants|||Number
637957|NCT02461992|Primary|Incremental Recovery (INCREC)|Incremental recovery is the increase in circulating FVIII activity for every IU of Xyntha administered per kilogram of body weight.|Pre-dose and 0.25, 0.5, 1, 3, 6, 9, 24, 28, 32, 48, and 72 hours post-dose|The PK parameter analysis population is defined as all participants enrolled and treated who have at least 1 of the PK parameters of primary interest reported.||IU/deciliter (dL) per IU/kg||Geometric Coefficient of Variation|Geometric Mean
637958|NCT02461992|Primary|Mean Residence Time (MRT)|MRT = AUMCinf / AUCinf, where AUMCinf is the area under the first moment curve from zero time to infinity calculated as AUMCinf = AUMCt + ((t x Ct) / kel) + (Ct / kel^2). AUMCt is the area under the first moment curve from zero time to time t calculated using the trapezoidal method.|Pre-dose and 0.25, 0.5, 1, 3, 6, 9, 24, 28, 32, 48, and 72 hours post-dose|The PK parameter analysis population is defined as all participants enrolled and treated who have at least 1 of the PK parameters of primary interest reported.||hour||Geometric Coefficient of Variation|Geometric Mean
637959|NCT02461992|Primary|Terminal Elimination Half-Life (t1/2)|Terminal half-life is the time measured for the plasma concentration to decrease by one half.|Pre-dose and 0.25, 0.5, 1, 3, 6, 9, 24, 28, 32, 48, and 72 hours post-dose|The PK parameter analysis population is defined as all participants enrolled and treated who have at least 1 of the PK parameters of primary interest reported.||hour||Standard Deviation|Mean
637960|NCT02461992|Primary|Terminal Phase Rate Constant (Kel)|Terminal phase rate constant is the absolute value of the slope of a linear regression during the terminal phase of the natural­-logarithm transformed concentration-­time profile.|Pre-dose and 0.25, 0.5, 1, 3, 6, 9, 24, 28, 32, 48, and 72 hours post-dose|The PK parameter analysis population is defined as all participants enrolled and treated who have at least 1 of the PK parameters of primary interest reported.||1/hour||Geometric Coefficient of Variation|Geometric Mean
637961|NCT02461992|Primary|Volume of Distribution at Steady-State (Vss)|Volume of distribution is the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vss is the volume of distribution at steady-state.|Pre-dose and 0.25, 0.5, 1, 3, 6, 9, 24, 28, 32, 48, and 72 hours post-dose|The PK parameter analysis population is defined as all participants enrolled and treated who have at least 1 of the PK parameters of primary interest reported.||mL/kg||Geometric Coefficient of Variation|Geometric Mean
637962|NCT02461992|Primary|Clearance (CL)|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Pre-dose and 0.25, 0.5, 1, 3, 6, 9, 24, 28, 32, 48, and 72 hours post-dose|The PK parameter analysis population is defined as all participants enrolled and treated who have at least 1 of the PK parameters of primary interest reported.||mL/hour/kg||Geometric Coefficient of Variation|Geometric Mean
637963|NCT02461992|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||Pre-dose and 0.25, 0.5, 1, 3, 6, 9, 24, 28, 32, 48, and 72 hours post-dose|The PK parameter analysis population is defined as all participants enrolled and treated who have at least 1 of the PK parameters of primary interest reported.||hour||Full Range|Median
637964|NCT02461992|Primary|Area Under the Plasma FVIII Activity-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf)||Pre-dose and 0.25, 0.5, 1, 3, 6, 9, 24, 28, 32, 48, and 72 hours post-dose|The PK parameter analysis population is defined as all participants enrolled and treated who have at least 1 of the PK parameters of primary interest reported.||IU*hour/mL||Geometric Coefficient of Variation|Geometric Mean
637965|NCT02461992|Primary|Area Under the Plasma FVIII Activity-Time Profile From Time 0 to Time of the Last Quantifiable Concentration (AUClast)||Pre-dose and 0.25, 0.5, 1, 3, 6, 9, 24, 28, 32, 48, and 72 hours post-dose|The PK parameter analysis population is defined as all participants enrolled and treated who have at least 1 of the PK parameters of primary interest reported.||IU*hour/mL||Geometric Coefficient of Variation|Geometric Mean
637966|NCT02461992|Primary|Maximum Plasma FVIII Activity (Cmax)||Pre-dose and 0.25, 0.5, 1, 3, 6, 9, 24, 28, 32, 48, and 72 hours post-dose|The pharmacokinetic (PK) parameter analysis population is defined as all participants enrolled and treated who have at least 1 of the PK parameters of primary interest reported.||IU/milliliter (mL)||Geometric Coefficient of Variation|Geometric Mean
638002|NCT02457611|Secondary|Change in HIV RNA From Day 1 to End of Treatment as Assessed by Proportion of Participants Who Had Confirmed HIV Virologic Rebound During the Study.|Participants with HIV virologic rebound was defined as participants with at least two HIV RNA ≥ 400 copies/mL at 2 consecutive post-baseline visits which are at least 2 weeks apart based on actual dates.|Day 1; Week 6|Safety Analysis Set||Participants|||Count of Participants
638052|NCT02454127|Secondary|LDL Cholesterol|Change from baseline LDL cholesterol at 1 year, measured in mg/dL|1 year|Intent-to-treat analysis. Missing data were replaced with baseline values||mg/dL||Standard Deviation|Mean
637967|NCT02461693|Primary|Vigilance Score on Computer-based Test Using Random, Visual Stimulus: Mean Time to a Correct Hit|"Scanning Visual Vigilance Test. This test assesses vigilance, ability to sustain attention during long, boring, continuous tasks that generate minimal cognitive load (Fine et al, 1994; Lieberman et al, 1998; 2002). The volunteer continuously scans a computer screen to detect an infrequent, difficult-to-detect stimulus that appears at random intervals and locations for 2 s. On average, a stimulus was presented once per minute. Upon detection of the stimulus, the volunteer pressed the space bar as rapidly as possible. Whether a stimulus was detected and time required for detection was recorded. Responses before or after stimulus occurrence were false alarms. The test lasted 60 minutes. - from our publication"|45 to 105 minutes post pill consumption|One participant who received the caffeine pill had to use the restroom during the vigilance testing period and had to stop the test. Due to a technicality of the computer program, her data for the vigilance test was not available for analysis.||seconds||Standard Error|Mean
637968|NCT02461693|Primary|Vigilance Score on Computer-based Test Using Random, Visual Stimulus: Number Correct, Number of False Alarm Hits|"Scanning Visual Vigilance Test. This test assesses vigilance, ability to sustain attention during long, boring, continuous tasks that generate minimal cognitive load (Fine et al, 1994; Lieberman et al, 1998; 2002). The volunteer continuously scans a computer screen to detect an infrequent, difficult-to-detect stimulus that appears at random intervals and locations for 2 s. On average, a stimulus was presented once per minute. Upon detection of the stimulus, the volunteer pressed the space bar as rapidly as possible. Whether a stimulus was detected and time required for detection was recorded. Responses before or after stimulus occurrence were false alarms. The test lasted 60 minutes. - from our publication"|45 to 105 minutes post pill consumption|One participant who received the caffeine pill had to use the restroom during the vigilance testing period and had to stop the test. Due to a technicality of the computer program, her data for the vigilance test was not available for analysis.||counts||Standard Error|Mean
637969|NCT02461693|Primary|Vigilance Score on Computer-based Test Using Random, Visual Stimulus: Proportion Correct (Out of 60)|"Scanning Visual Vigilance Test. This test assesses vigilance, ability to sustain attention during long, boring, continuous tasks that generate minimal cognitive load (Fine et al, 1994; Lieberman et al, 1998; 2002). The volunteer continuously scans a computer screen to detect an infrequent, difficult-to-detect stimulus that appears at random intervals and locations for 2 s. On average, a stimulus was presented once per minute. Upon detection of the stimulus, the volunteer pressed the space bar as rapidly as possible. Whether a stimulus was detected and time required for detection was recorded. Responses before or after stimulus occurrence were false alarms. The test lasted 60 minutes. - from our publication"|45 to 105 minutes post pill consumption|One participant who received the caffeine pill had to use the restroom during the vigilance testing period and had to stop the test. Due to a technicality of the computer program, her data for the vigilance test was not available for analysis.||Proportion correct||Standard Error|Mean
637970|NCT02461693|Primary|Mood State Score on POMS-2 Test|"Profile of Mood States (POMS-2)- Volunteers rated a series of 65 mood-related adjectives with regard to how they were feeling “right now” on a scale of 0 (not at all) to 4 (extremely). The adjectives factor into six mood sub-scales: Tension-Anxiety; Depression-Dejection; Anger-Hostility; Vigor-Activity; Fatigue-Inertia; Confusion-Bewilderment and a Total Mood Disturbance score which aggregates the six sub-scales into a single variable. - from our publication. The minimum and maximum possible raw scores were: 0 and 40 for Tension-Anxiety, 0 and 52 for Depression-Dejection, 0 and 44 for Anger-Hostility, 0 and 36 for Vigor-Aactivity, 0 and 24 for Fatigue-Inertia, 0 and 40 for Confusion-Bewilderment, -36 and 200 for Total Mood Disturbance, and 0 and 24 for Friendliness. For Friendliness and Vigor-Activity, the more positively a person feels, the higher the score. For all other sub-scales and Total Mood Disturbance, the more negatively a person feels, the higher the score."|30 minutes post pill consumption|Results are of raw data as presented in our publication||units on a scale||Standard Error|Mean
637971|NCT02461290|Secondary|Percentage of Participants Alive at 1, 2, and 3 Years|Participants were followed for survival for up to 3 years. The overall survival rate at 1, 2, and 3 years was calculated as [number of participants alive divided by the number analyzed] multiplied by 100.|At 1, 2, and 3 years|ITT Population.||percentage of participants|||Number
637972|NCT02461290|Secondary|Percentage of Participants With CR According to International Working Group Response Criteria for NHL|Tumor response was evaluated according to criteria published by Cheson et al (1999). According to consensus recommendations, CR was defined as disappearance of all clinical/radiographic evidence of disease, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. The percentage of participants achieving CR was calculated as [number of participants meeting the above criteria divided by the number analyzed] multiplied by 100.|Up to 18 months (at Screening, Baseline, end of induction therapy, and in accordance with routine practice)|Data Analysis Population.||percentage of participants|||Number
637973|NCT02461290|Secondary|Percentage of Participants With Complete Remission (CR) or Partial Remission (PR) According to International Working Group Response Criteria for Non-Hodgkin's Lymphoma (NHL)|Tumor response was evaluated according to criteria published by Cheson et al (1999). According to consensus recommendations, CR was defined as disappearance of all clinical/radiographic evidence of disease, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. PR was defined as greater than or equal to (≥) 50 percent (%) decrease in sum of the products of greatest diameters (SPD) of the six largest dominant lymph nodes, no increase in size of other nodes, no increase in liver or spleen volume, a ≥50% decrease in SPD of hepatic and splenic nodules, absence of other organ involvement, and no new sites of disease. The percentage of participants achieving CR or PR was calculated as [number of participants meeting the above criteria divided by the number analyzed] multiplied by 100.|Up to 18 months (at Screening, Baseline, end of induction therapy, and in accordance with routine practice)|Data Analysis Population: All enrolled participants who provided complete and evaluable outcome data.||percentage of participants|||Number
638003|NCT02457611|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as:
On-treatment virologic failure
confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ, while on treatment (ie, breakthrough),
confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment (ie, rebound),
HCV RNA persistently ≥ LLOQ through end of treatment (ie, nonresponse)
Relapse
HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement"|Up to Posttreatment Week 12|Full Analysis Set||percentage of participants|||Number
637974|NCT02461290|Primary|Number of Participants With an Adverse Event (AE), Serious AE, or Death Related to AE|The safety and tolerability of rituximab was evaluated by collection of AEs, including clinically significant abnormalities and changes in laboratory data. An AE was defined as any untoward medical occurrence in a study participant regardless of the suspected cause. Serious AEs were those which, at any dose, met one or more of the following criteria: resulted in fatality, were life-threatening, necessitated new or prolonged existing hospitalization, produced persistent or significant disability, resulted in a congenital anomaly or birth defect, were considered medically significant, or required intervention to prevent any of the aforementioned outcomes. Those specific serious AEs which resulted in fatality were also reported separately.|Up to 3 years (at Screening, Baseline, end of induction therapy, and in accordance with routine practice)|ITT Population.||participants|||Number
637975|NCT02460822|Secondary|Improved Quality of Life|"The investigators will use the FACT-G survey to assess four dimensions of patients health (physical, functional, social and emotional). For each of the dimensions, patients are given a series of statements about specific elements of well being and asked to rank them on the following scale: Not at all, a little bit, Somewhat, Quite a bit, or Very much. These items are given numeric values of 0-4, with negatively worded statements reverse coded. Within each of the four dimensions of health, average scores are calculated, and then an overall sum is derived. Total well-being ranges from 0 (Complete lack of well being) to 16 (Completely well).
The number presented is the count of participants for whom the overall FACT-G score increased between baseline and 8-week followup. Because this is a small pilot study, we measure ANY increase with no threshold specified."|Baseline and 8 weeks post enrollment|||Participants|||Count of Participants
637976|NCT02460822|Secondary|Symptom Burden Reduction|"The investigators will use the MD Anderson Symptom Inventory (MDASI) to describe patient experiences in 8 core symptom areas (pain, fatigue, nausea, disturbed sleep, distress, lack of appetite, weakness, and diarrhea). For each area, patients are asked to rank their symptoms on a scale from 0 (Not present) to 10 (As bad as you can imagine). The overall score is the mean across all 8 items.
The number reported here is the count of patients with a reduction in symptom burden between baseline and 8-week follow up. Because this is a small pilot study, we measure ANY reduction with no threshold specified."|8 weeks post enrollment|||Participants|||Count of Participants
637977|NCT02460822|Secondary|Increased Mastery of Cancer and Chemotherapy Symptoms|"The investigators will use the Cancer Care Mastery Scale to assess patients' feelings of control over their cancer care. This scale is based on the Mastery Scale developed by Pearlin and Schooler, designed to capture the sense of control a patient feels over their cancer care. This is a 7-item scale where users are asked to respond to statements by choosing and answer from the following: Strongly disagree, Disagree, Neither agree or disagree, Agree, Strongly agree. Mastery scores were computed by taking the numeric mean of the items (1-5), with negatively worded items reversed.
The number presented here is the number of patients whose mastery score improved between baseline and the end of the 8-week program. Because this is a small pilot study, we measure ANY improvement with no threshold specified."|8 weeks post enrollment|||Participants|||Count of Participants
637978|NCT02460822|Secondary|Physician Use of the Study Feedback Mechanism|The investigators will assess for how many of the enrolled patients the physicians use the feedback from the app to assist in clinical care of the patients. This includes following up about distressing symptoms and using information provided by the patient during regular clinical visits.|8 weeks post-enrollment|||Participants|||Count of Participants
637979|NCT02460822|Primary|Patient Satisfaction and Usability of the MyChemoCare Application|"The investigators will use a 9-item survey developed by Dr. An to assess patients' experiences using the MyChemoCare app.
This result is the mean of the the survey items (with opposite items reversed). The scale was scored from 0 = Strongly disagree to 6 = Strongly agree."|8 weeks post enrollment|||units on a scale||Standard Error|Mean
637980|NCT02460822|Primary|Patient Retention and Engagement With the MyChemoCare Application|Patient retention is defined as the number of patients who completed the 8-week study through the final evaluation. Engagement with the MyChemoCare application was measured as number of patients who checked in at least once per week of the study.|8 weeks post-enrollment|||Participants|||Count of Participants
637981|NCT02460458|Primary|Type of VWF/FVIII-containing Concentrates in Use|Record of any VWF/FVIII-containing concentrates used and currently in use, including the current schedule type of treatment.|24 months (prospective phase)||||||
637982|NCT02460458|Primary|Adverse Events|Record of all adverse events occurred during the prospective phase of the study.|24 months (prospective phase)||||||
637983|NCT02460458|Primary|Record of Bleeding Episodes|Bleeding: severity, start date, stop date; Treatment: Product name, start date, stop date, Total IU, Total ED.|24 months (prospective phase)||||||
637984|NCT02460458|Primary|Allergic Reactions During Use of VWF-containing Concentrates|Record of any allergic and anaphilactic reactions occurred in the past due to the use of any VWF concentrate and the date of onset.|24 months (retrospective)|||participants|||Number
637985|NCT02460458|Primary|Previous Use of Blood Products|Record of any product used in the previous 24 months (collected type of blood products/VWF concentrate, year of first exposure, units used).|24 months (retrospective)|||participants|||Number
637986|NCT02460458|Primary|Molecular Diagnosis of VWF in DNA|Evaluation of the presence of VWF gene defects (confirmation or screening for the first time).|36 months (retrospective + confirmatory phase)||||||
637987|NCT02460458|Primary|Test for Anti-VWF Antibodies|Evaluation of the titre of Anti-VWF Antibodies through Bethesda test (BU).|36 months (retrospective + confirmatory phase)||||||
637988|NCT02460458|Primary|General Laboratory Tests for VWD3 Diagnosis (Composite)|Hemoglobin: (mmol/L), HT(%), MVC (fl); Leucocytes: (E9/L); Neutrophil (%); Basophil (%); Eosinophil (%); Lymphocyte (%); Platelet count: (E9/L), MPV (fl); Prothrombin Time (sec); PTT (sec); PTT mix 50:50 (sec); Ferritin (ug/l); Bleeding Time (min:sec); Closure Time (Sec); Collagen/ADP (sec); Collagen/Epinephrine (sec); FVIII:C (IU/mL); VWF:RCo (IU/mL); VWF:Ag (IU/mL).|36 months (retrospective + confirmatory phase)||||||
638004|NCT02457611|Secondary|Change From Baseline in HCV RNA at Weeks 2, 4, and 6||Baseline; Weeks 2, 4, and 6|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
638005|NCT02457611|Secondary|Percentage of Participants With HCV RNA < LLOQ on Treatment||Weeks 2, 4, and 6|Full Analysis Set||percentage of participants||95% Confidence Interval|Number
638053|NCT02454127|Secondary|Total Cholesterol|Change in total cholesterol from baseline at 1 year, measured in mg/dL|1 year|Intent-to-treat analysis. Missing data were replaced with baseline data.||mg/dL||Standard Deviation|Mean
637989|NCT02460458|Primary|Bleeding Severity Score (BSS)|The range of measurement is from -1 to +4 for each symptom considered (12 symptoms, total range from -12 to 48). For each symptom: 0=no symptom, 1=referred by the patient, 2=brought to medical attention, 3=major intervention. For spontaneous hemorrhagic symptoms, scores equal or greater than two require that the patient has specifically addressed that hemorrhagic symptom with a physician, whatever has been the diagnosis and therapy subsequently proposed. Score 0 and 1 are attributed to symptoms referred by the patient, hence without any precise medical intervention. Score 0 is for negligible or absent symptoms; 1 otherwise. For surgical procedures, it is considered important to differentiate between patients that have never bled because they never underwent surgery and those that did not bled after a surgery. These latter receive a negative score, indicating that the probability of VWD diminishes if you don’t bleed after surgery.|24 months (retrospective phase)|||Score on a scale||Full Range|Median
637990|NCT02458768|Primary|Number of Retrieved Oocytes||36 hrs (±3 hrs) after administration of the ovulation stimulant|Per-Protocol Set||Oocytes||Standard Deviation|Mean
637991|NCT02458365|Other Pre-specified|Number of Participants Experiencing Emotional Peer Violence During Follow-up|"See above. One or more incidents of peer emotional mistreatment experienced during the period in question were coded as yes, and no incidents coded as no)."|One year|Participants who were not exposed to at least minimal risk for dating violence (see definition of minimal risk above); among 725 participants not exposed to risk, 44 were inadvertently administered the wrong measures and thus were excluded from analyses, leaving N = 681.||participants|||Number
637992|NCT02458365|Other Pre-specified|Number of Participants Perpetrating Emotional Peer Violence During Follow-up|"See above. One or more incidents of peer emotional mistreatment perpetrated during the period in question were coded as yes, and no incidents coded as no)."|One year|Participants who were not exposed to at least minimal risk for dating violence (see definition of minimal risk above); among 725 participants not exposed to risk, 44 were inadvertently administered the wrong measures and thus were excluded from analyses, leaving N = 681.||participants|||Number
637993|NCT02458365|Other Pre-specified|Number of Participants Experiencing Physical Peer Violence During Follow-up|"See above. Cronbach's Alphas for the three victimization scales were .89 for emotional mistreatment, .89 for physical violence, and .93 for sexual coercion. One or more incidents of physical peer violence victimization during the period in question were coded as yes, and no incidents coded as no)."|One year|Participants who were not exposed to at least minimal risk for dating violence (see definition of minimal risk above); among 725 participants not exposed to risk, 44 were inadvertently administered the wrong measures and thus were excluded from analyses, leaving N = 681.||participants|||Number
637994|NCT02458365|Other Pre-specified|Number of Participants Perpetrating Physical Peer Violence During Follow-up|"Among participants not exposed to risk for dating violence, an 18-item measure assessed three types of peer violence perpetration and victimization (Levesque, 2007). Alphas for the three 3-item perpetrator scales are: .89 for emotional mistreatment, .89 for physical violence, and .94 for sexual coercion. At follow-up, in the spring and fall of 2010, the measure assessed peer violence experienced and perpetrated since January 1, 2010. Given the hierarchical structure of the perpetration measure, the physical violence and sexual coercion scales were combined to represent physical perpetration. One or more incidents of physical perpetration during the period in question were coded as yes, and no incidents coded as no."|One year|Participants who were not exposed to at least minimal risk for dating violence (see definition of minimal risk above); among 725 participants not exposed to risk, 44 were inadvertently administered the wrong measures and thus were excluded from analyses, leaving N = 681.||participants|||Number
637995|NCT02458365|Secondary|Number of Participants Experiencing Emotional Dating Violence During Follow-up|"See above.One or more incidents of emotional dating violence victimization during the period in question were coded as yes, and no incidents coded as no)."|One year|Participants who were exposed to at least minimal risk for dating violence -- i.e., who had experienced or perpetrated emotional or physical dating violence in the year prior to the study, who were current daters at baseline, or who dated during the follow-up period.||participants|||Number
637996|NCT02458365|Secondary|Number of Participants Perpetrating Emotional Dating Violence During Follow-up|"See above.One or more incidents of emotional dating violence perpetration during the period in question were coded as yes, and no incidents coded as no)."|One year|Participants who were exposed to at least minimal risk for dating violence -- i.e., who had experienced or perpetrated emotional or physical dating violence in the year prior to the study, who were current daters at baseline, or who dated during the follow-up period.||participants|||Number
637997|NCT02458365|Secondary|Number of Participants Experiencing Physical Dating Violence During Follow-up|"See above. Cronbach's Alphas for the five victimization scales were .87 for emotional mistreatment, .86 for controlling behavior, .83 for threats, .76 for physical violence, and .90 for sexual coercion. One or more incidents of physical dating violence victimization during the period in question were coded as yes, and no incidents coded as no)."|One year|Participants who were exposed to at least minimal risk for dating violence -- i.e., who had experienced or perpetrated emotional or physical dating violence in the year prior to the study, who were current daters at baseline, or who dated during the follow-up period.||participants|||Number
637998|NCT02458365|Primary|Number of Participants Perpetrating Physical Dating Violence During Follow-up|"A 30-item measure assessing five types of dating violence perpetration and victimization was developed to meet specific needs of this research (Levesque, 2007). Alphas for the five 3-item perpetrator scales are: .88 for emotional mistreatment, .87 for controlling behavior, .91 for threats, .92 for physical violence, and .94 for sexual coercion. At follow-up, in the spring and fall of 2010, the measure assessed dating violence perpetrated and experienced since January 1, 2010. Given the hierarchical structure of the perpetration measure, the emotional mistreatment and controlling behavior scales were combined to represent emotional dating violence perpetration, and the threats, physical violence, and sexual coercion scales were combined to represent physical perpetration. Given extreme non-normal distributions, the two measures were then dichotomized. One or more incidents of physical perpetration during the period in question were coded as yes, and no incidents as no."|One year|Participants who were exposed to at least minimal risk for dating violence -- i.e., who had experienced or perpetrated emotional or physical dating violence in the year prior to the study, who were current daters at baseline, or who dated during the follow-up period.||participants|||Number
643874|NCT02226198|Secondary|ApoB/ApoA|Efficacy in terms of apolipoprotein B (ApoB) / apolipoprotein A (ApoA)|Samples taken at Day 42 (week 6) and Day 84 (week 12)|||ratio||Standard Deviation|Mean
638008|NCT02457611|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Completion of Treatment (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.|Posttreatment Week 12|Full Analysis Set: participants with genotype 1 or 4 HCV infection who were enrolled into the study and received at least 1 dose of study drug||percentage of participants||95% Confidence Interval|Number
638009|NCT02457247|Secondary|Product Tolerability Expressed as the Percentage of Participants Who Experience at Least One Treatment-Emergent Adverse Event Within Each Test Group|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|Day 1 to Day 28|The Safety Analysis Set included all randomized participants who received at least 1 dose of study medication.||percentage of participants|||Number
638010|NCT02457247|Secondary|Product Acceptability After Each 14 Day Dosing Period Within Each Test Group|Product acceptability was assessed by a 6 item questionnaire evaluating the characteristics of the product: gritty, chalky, sweet, ease of chew, ease of swallow and sticky. Using a 100 mm visual analog scale (VAS) the participant put a vertical line through each horizontal line that best describes their level of agreement with each item using a 0 to 100 scale where: 0=far left of the line (best) to 100= far right of the line (worst). Linear mixed model was used for analysis with treatment and period as fixed effects and participants as a random effect.|Day 14 and Day 28|The FAS included all randomized participants.||mm||Standard Error|Least Squares Mean
638011|NCT02457247|Primary|Percentage of Participants With a Preference for Each Treatment Within Each Test Group|Preference was assessed by a 3 box questionnaire. Participants checked off one of the boxes: I prefer the first product that was tested, I prefer the second product that was tested or I have no preference. Test Group 1 (United Kingdom): Calcichew D3 is 500/400 and the comparator is Adcal-D3. Test Group 2 (Germany): Calcichew D3 is 500/800 and the comparator is Kalcipos-D.|Day 28|All randomized participants from the Full Analysis Set (FAS) who received at least 1 dose of study medication and responded to the preference questionnaire.||percentage of participants|||Number
638012|NCT02455050|Secondary|Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 2|Participants completed the 4 question Eye Drop Experience Survey at 5 and 30 minutes post drop instillation: Question (Q) 1-vision clear/without blur, Q2-drops soothing/comfortable, Q3-drops relieve dry eye symptoms and Q4-comfortable/soothing. Q1 to Q3 were answered using a 5-point scale: 1=strongly disagree to 5=strongly agree. Q4 is answered using a Labeled Hedonic scale by placing a mark on a vertical line where the bottom of the line -100=most uncomfortable/irritating imaginable, middle of the line=neutral to top of the line 100=most comfortable/soothing imaginable.|After 14 days of treatment in Period 2 (Follow-up 2 Day 35), 5 and 30 minutes post drop instillation|Participants from the Primary Efficacy Population, all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit and participated in Period 2.||score on a scale||Standard Deviation|Mean
638013|NCT02455050|Secondary|Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 1|Participants completed the 4 question Eye Drop Experience Survey at 5 and 30 minutes post drop instillation: Question (Q) 1-vision clear/without blur, Q2-drops soothing/comfortable, Q3-drops relieve dry eye symptoms and Q4-comfortable/soothing. Q1 to Q3 were answered using a 5-point scale: 1=strongly disagree to 5=strongly agree. Q4 is answered using a Labeled Hedonic scale by placing a mark on a vertical line where the bottom of the line -100=most uncomfortable/irritating imaginable, middle of the line=neutral to top of the line 100=most comfortable/soothing imaginable.|After 14 days of treatment in Period 1 (Follow-up 1 Day 14), 5 and 30 minutes post drop instillation|Primary Efficacy Population consisted of all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit.||score on a scale||Standard Deviation|Mean
638014|NCT02455050|Secondary|Tear Break-Up Time With Fluorescein in Period 2|Fluorescein was applied to the eyes and three consecutive TBUTs are performed in each eye at 5 and 30 minutes post drop instillation. TBUT is defined as the time (seconds) required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film.|After 14 days of treatment in Period 2 (Follow-up 2 Day 35), 5 and 30 minutes post drop instillation|Participants from the Primary Efficacy Population, all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit and participated in Period 2.||seconds||Standard Deviation|Mean
638015|NCT02455050|Secondary|Tear Break-Up Time With Fluorescein in Period 1|Fluorescein was applied to the eyes and three consecutive TBUTs are performed in each eye at 5 and 30 minutes post drop instillation. TBUT is defined as the time (seconds) required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film.|After 14 days of treatment in Period 1 (Follow-up 1 Day 14), 5 and 30 minutes post drop instillation|Primary Efficacy Population consisted of all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit.||seconds||Standard Deviation|Mean
638016|NCT02455050|Secondary|Distance Visual Acuity in Period 2|Distance visual acuity is measured in each eye at 5 and 30 minutes post drop instillation using an eye chart at 4 meters and is reported as the number of letters read correctly (ranging from 0 to 100 letters).|After 14 days of treatment in Period 2 (Follow-up 2 Day 35), 5 and 30 minutes post drop instillation|Participants from the Primary Efficacy Population, all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit and participated in Period 2.||Letters Read Correctly||Standard Deviation|Mean
638017|NCT02455050|Secondary|Distance Visual Acuity in Period 1|Distance visual acuity is measured in each eye at 5 and 30 minutes post drop instillation using an eye chart at 4 meters and is reported as the number of letters read correctly (ranging from 0 to 100 letters).|After 14 days of treatment in Period 1 (Follow-up 1 Day 14), 5 and 30 minutes post drop instillation|Primary Efficacy Population consisted of all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit.||Letters Read Correctly||Standard Deviation|Mean
638054|NCT02454127|Primary|Weight Loss|Change from baseline body weight at 1 year, measured in kilograms|1 year|Intent-to-treat analysis. Missing data were replaced with baseline values.||kg||Standard Deviation|Mean
638055|NCT02454101|Secondary|Duration of Third Stage of Labor|number of minutes from delivery of the baby till delivery of the placenta|immediatly after delivery|||minutes||Standard Deviation|Mean
638018|NCT02455050|Secondary|Percentage of Participants by Response in End of Study Survey: Assessing Comfort, Blur, and Relief of Symptoms (New Eye Drop Formulation Versus Genteal®)|End of Study Survey consisted of 4 questions assessing product preference: Q1-overall comfort, Q2-symptom relief, Q3-less blurring and Q4-preference/willingness to purchase the product. The participant answered each questions using the scale: a=first product better, b=second product better or c=equal. The percentage of participants in each response category is reported.|Day 35|Primary Efficacy Population consisted of all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit. Data is missing for 6 participants.||percentage of participants|||Number
638019|NCT02455050|Secondary|Percentage of Participants by Response in End of Study Survey: Assessing Comfort, Blur, and Relief of Symptoms (New Eye Drop Formulation Versus Systane®)|End of Study Survey consisted of 4 questions assessing product preference: Q1-overall comfort, Q2-symptom relief, Q3-less blurring and Q4-preference/willingness to purchase the product. The participant answered each questions using the scale: a=first product better, b=second product better or c=equal. The percentage of participants in each response category is reported.|Day 35|Primary Efficacy Population consisted of all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit. Data is missing for 3 participants.||percentage of participants|||Number
638020|NCT02455050|Secondary|Subjective Evaluation of Symptoms of Dryness (SESoD) Score Using a 5-Point Scale in Period 2|SESoD assessed the severity of dryness (defined as discomfort/irritation due to dry feeling in the eye) evaluated by the participant on a 5-point scale: 0=none, 1=trace, 2=mild, 3=moderate and 4=severe (always notice the symptom and interferes with activities).|Baseline and After 14 days of treatment in Period 2 (Follow-up 2 Day 35)|Participants from the Primary Efficacy Population, all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit and participated in Period 2.||score on a scale||Standard Deviation|Mean
638021|NCT02455050|Secondary|Subjective Evaluation of Symptoms of Dryness (SESoD) Score Using a 5-Point Scale in Period 1|SESoD assessed the severity of dryness (defined as discomfort/irritation due to dry feeling in the eye) evaluated by the participant on a 5-point scale: 0=none, 1=trace, 2=mild, 3=moderate and 4=severe (always notice the symptom and interferes with activities).|Baseline and After 14 days of treatment in Period 1 (Follow-up 1 Day 14)|Primary Efficacy Population consisted of all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit.||score on a scale||Standard Deviation|Mean
638022|NCT02455050|Secondary|Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 2|Acceptability Survey is comprised of 8 questions (Q): Q1-effective dry-eye relief, Q2-eyes feel comfortable, Q3-vision did not blur, Q4-vision normal within 10 minutes, Q5-substantial feel/optimally thick, Q6-eyelashes not matted/crusty, Q7- satisfied overall and Q8-switch to this product/if my doctor recommended. The participant answered the questions using the following scale: a=strongly agree, b=agree, c=neither agree nor disagree, d=disagree and e=strongly disagree. The percentage of participants who selected Strongly Agree or Agree is reported.|After 14 days of treatment in Period 2 (Follow-up 2 Day 35)|Participants from the Primary Efficacy Population, all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit and participated in Period 2.||percentage of participants|||Number
638023|NCT02455050|Secondary|Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 1|Acceptability Survey is comprised of 8 questions (Q): Q1-effective dry-eye relief, Q2-eyes feel comfortable, Q3-vision did not blur, Q4-vision normal within 10 minutes, Q5-substantial feel/optimally thick, Q6-eyelashes not matted/crusty, Q7- satisfied overall and Q8-switch to this product/if my doctor recommended. The participant answered the questions using the following scale: a=strongly agree, b=agree, c=neither agree nor disagree, d=disagree and e=strongly disagree. The percentage of participants who selected Strongly Agree or Agree is reported.|After 14 days of treatment in Period 1 (Follow-up 1 Day 14)|Primary Efficacy Population consisted of all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit.||percentage of participants|||Number
638024|NCT02455050|Secondary|Ocular Surface Disease Index© (OSDI©) Score Using a 5-Point Scale in Period 2|The OSDI Questionnaire consisted of 12 questions: ocular symptoms (sensitive to light, feel gritty, painful or sore), vision-related functions (blurred vision, poor vision, reading, driving at night, working on a computer and watching TV) and environmental triggers (windy conditions, low humidity/dry areas and air-conditioned areas). Participants were asked to base their evaluation on the frequency of their symptoms over the last week, using a 5-point scale: 0=none of the time to 4=all of time. The total score is converted to a 0 to 100 score where 0 is best and 100 is worst.|Baseline and after 14 days of treatment in Period 2 (Follow-up 2 Day 35)|Participants from the Primary Efficacy Population, all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit and participated in Period 2.||score on a scale||Standard Deviation|Mean
638025|NCT02455050|Secondary|Ocular Surface Disease Index© (OSDI©) Score Using a 5-Point Scale in Period 1|The OSDI Questionnaire consisted of 12 questions: ocular symptoms (sensitive to light, feel gritty, painful or sore), vision-related functions (blurred vision, poor vision, reading, driving at night, working on a computer and watching TV) and environmental triggers (windy conditions, low humidity/dry areas and air-conditioned areas). Participants were asked to base their evaluation on the frequency of their symptoms over the last week, using a 5-point scale: 0=none of the time to 4=all of time. The total score is converted to a 0 to 100 score where 0 is best and 100 is worst.|Baseline and after 14 days of treatment in Period 1 (Follow-up 1 Day 14)|Primary Efficacy Population consisted of all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit.||score on a scale||Standard Deviation|Mean
638056|NCT02454101|Secondary|Maternal Additional Need for Therapeutic Uterotonics|number of mothers need for > 20 units of Oxycontin in the 1st 24 hours of delivery|1st 24 hours of delivery|||participants|||Number
638057|NCT02454101|Secondary|Maternal Need for Blood Transfusion.|number of mothers with hemoglobin level < 7mg/dl and need for blood transfusion|1st 24 hours after delivery|||participants|||Number
638205|NCT02446990|Secondary|Coronary Mortality|Coronary mortality including sudden death of unknown cause, death from myocardial infarction, death from heart failure, death from coronary artery procedure, presumed arrhythmic death|From the date of randomisation to death, up to 48 months|||participants|||Number
638026|NCT02455050|Primary|Tolerability Survey Score Using a 100 Unit Visual Analog Scale (VAS) in Period 2|Tolerability was assessed using an 8-item survey consisting of 4 positive questions: comfort, soothing, moistening/lubricating and vision clarity and 4 negative questions: stickiness, blur, burning/stinging and discomfort. Participants were instructed to think about their experience over the past week and place a vertical line on the line that best captured how they felt the first 30 minutes after the study drops were administered using the scale: 0 far left of the line to 100 far right on the line. The individual positive scores are added together to obtain the total positive tolerability score from 0 (worst) to 400 (best) and the individual negative scores are added together to obtain the total negative tolerability score for a total possible score of 0 (best) to 400 (worst).|After 14 days of treatment in Period 2 (Follow-up 2 Day 35)|Participants from the Primary Efficacy Population, all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit and participated in Period 2.||score on a scale||Standard Deviation|Mean
638027|NCT02455050|Primary|Tolerability Survey Score Using a 100 Unit Visual Analog Scale (VAS) in Period 1|Tolerability was assessed using an 8-item survey consisting of 4 positive questions: comfort, soothing, moistening/lubricating and vision clarity and 4 negative questions: stickiness, blur, burning/stinging and discomfort. Participants were instructed to think about their experience over the past week and place a vertical line on the line that best captured how they felt the first 30 minutes after the study drops were administered using the scale: 0 far left of the line to 100 far right on the line. The individual positive scores are added together to obtain the total positive tolerability score from 0 (worst) to 400 (best) and the individual negative scores are added together to obtain the total negative tolerability score for a total possible score of 0 (best) to 400 (worst).|After 14 days of treatment in Period 1 (Follow-up 1 Day 14)|Primary Efficacy Population consisted of all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit. Participants enrolled in Period 1.||score on a scale||Standard Deviation|Mean
638028|NCT02454959|Secondary|Tmax on Day 8|Pharmacokinetic Parameter tmax of Formoterol by Treatment on Day 8|Day 8|Pharmacokinetic Population||h||Full Range|Median
638029|NCT02454959|Secondary|Tmax on Day 8|Pharmacokinetic Parameter tmax of Glycopyrronium by Treatment on Day 8|Day 8|Pharmacokinetic Population||h||Full Range|Median
638030|NCT02454959|Secondary|Cmax on Day 8|Pharmacokinetic Parameter Cmax of Formoterol by Treatment on Day 8|Day 8|Pharmacokinetic Population||pg/mL||Standard Deviation|Mean
638031|NCT02454959|Secondary|Cmax on Day 8|Pharmacokinetic Parameter Cmax of Glycopyrronium by Treatment on Day 8|Day 8|Pharmacokinetic Population||pg/mL||Standard Deviation|Mean
638032|NCT02454959|Secondary|AUC0-12 on Day 8|Pharmacokinetic Parameter AUC0-12 of Formoterol by Treatment on Day 8|Day 8|Pharmacokinetic Population||h*pg/mL||Standard Deviation|Mean
638033|NCT02454959|Secondary|AUC0-12 on Day 8|Pharmacokinetic Parameter AUC0-12 of Glycopyrronium by Treatment on Day 8|Day 8|Pharmacokinetic Population||h*pg/mL||Standard Deviation|Mean
638034|NCT02454959|Primary|Area Under the Curve for Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) From 0 to 12 Hours (AUC0-12) on Day 8|AUC0-12 was calculated using the trapezoidal rule based on FEV1 assessments at pre-dose, and 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 10 hours, 11.5 hours, and 12 hours post-dosing of study drug. Primary Outcome was calculated using the trapezoidal rule and was modeled conditionally on baseline FEV1.|7 days of treatment|The primary analysis used the Modified-Intent-to-Treat (MITT) Population.||Liter||Standard Error|Least Squares Mean
638042|NCT02454296|Secondary|Paracervical or Sham Block Pain|Participants reported her pain level on the 100 mm Visual Analog Scale (VAS) within 10 seconds after she received either the paracervical block or the sham block. The VAS is a validated measure of pain where 0=no pain and 100=worst pain ever felt.|Within 10 seconds after receiving paracervical or sham block|||units on a scale (100 mm VAS)||Inter-Quartile Range|Median
638043|NCT02454296|Secondary|Satisfaction With Overall Pain Control (100 mm Visual Analog Scale)|Patients rated their satisfaction with overall pain control on the 100 mm VAS, with 0 as not satisfied at all and 100 as completely satisfied|15 minutes post-operatively|||units on a scale (100 mm VAS)||Inter-Quartile Range|Median
638044|NCT02454296|Primary|Pain After Placement of Laminaria (100 mm Visual Analog Scale)|We asked the participant to rate her pain on a 100 mm Visual Analog Scale (VAS) immediately after laminaria was placed. The VAS is a validated measure of pain where 0=no pain and 100=worst pain ever felt.|Measured within 10 seconds after placement of laminaria|||units on a scale (100 mm VAS)||Inter-Quartile Range|Median
638045|NCT02454283|Secondary|Length of Stay (From Time of Study Drug Administration)||8 days|||days||Standard Deviation|Mean
638046|NCT02454283|Primary|Conversion to Sinus Rhythm|Conversion to sinus rhythm (or atrial paced rhythm in the case of subjects with a pacemaker and atrial leads) documented by ECG (Holter ECG, 12-lead ECG, monitor lead ECG, or other format ECG) of at least 1 continuous minute within the 24 hours defined by the time of study drug administration through 24 hours after the time of study drug administration.|24 hours|||participants|||Number
638144|NCT02448914|Secondary|Number of Adverse Events||Patients will be followed for the duration of the hospital stay, an expected average of 3 days|||adverse events|||Number
638058|NCT02454101|Secondary|Neonatal Apgar Score (After 5 Minutes of Delivery).|"The Apgar test is done by a doctor, midwife, or nurse. The health care provider examines the baby's:
Breathing effort
Heart rate
Muscle tone
Reflexes
Skin color
Each category is scored with 0, 1, or 2, depending on the observed condition.
The Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth.
A score of 7, 8, or 9 is normal and is a sign that the newborn is in good health. A score of 10 is very unusual, since almost all newborns lose 1 point for blue hands and feet, which is normal for after birth.
Any score lower than 7 is a sign that the baby needs medical attention. The lower the score, the more help the baby needs"|5 minutes of delivery|Number of Infants Analyzed||Scores on a Scale from 1 to 10||Standard Deviation|Mean
638059|NCT02454101|Secondary|Neonatal Intensive Care Unit (NICU) Admission|number of Neonatal Intensive Care unit (NICU) admission in the 1st 24 hours after delivery|1st 24 hours after delivery|Number of Infants Analyzed||participants|||Number
638060|NCT02454101|Secondary|Neonatal Intubation|number of newborns requirng intubation in the first 2 hours after delivery|1st 2 hours after delivery|Number of Infants Analyzed||participants|||Number
638061|NCT02454101|Secondary|Severe Postpartum Haemorrage|(measured blood loss 1000 mL or more|24 hours after labor|||participants|||Number
638062|NCT02454101|Secondary|Jundice Requring Phtotherapy|number of infants requiring phtotherapy for jundice in the first 2 weeks|two weks|Number of Infants Analyzed||participants|||Number
638063|NCT02454101|Primary|Neonatal Hemoglobin Level|neonatal 6 weeks hemoglobin measured in gram %|6 weeks after labor|Number of Infants Analyzed||gram%||Standard Deviation|Mean
638064|NCT02453581|Primary|500mg Cohort Mean Parasite Reduction Ratio (PRR)|OZ439 500mg individual subject PRR and corresponding 95% CI were used to calculate the OZ439 500mg cohort specific PRR and the corresponding 95% CI: the weighted average slope estimate and corresponding SE were calculated by the inverse-variance method.|48 hours|As the doses of 100 mg and 200 mg of OZ439 in Cohorts 1 and 2 were inadequate to eliminate the parasites and regrowth occurred, PRR calculations were only undertaken for subjects receiving 500mg of OZ439 in Cohort 3. With a p value of 0.0046, Subject S036 was excluded from this calculation||none (ratio)||95% Confidence Interval|Mean
638065|NCT02453581|Secondary|OZ439 AUC(0-144)|OZ439 Area under the curve to 144 hours|Pre-dose, and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose|All 24 subjects randomized and completed the study.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
638066|NCT02453581|Secondary|OZ439 Cmax|OZ439 Maximum concentration (Cmax)|Pre-dose, and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose|All 24 subjects randomized and completed the study.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
638067|NCT02453581|Primary|Individual Parasite Reduction Ratio (PRR)|"PRR estimates the efficacy of an anti-malarial treatment and is the ratio of the parasite density between admission and 48 hours post-treatment.
Individual subject PRR and corresponding 95% CI were calculated using the slope and corresponding standard error of mean (SE) of the optimal regression model."|48 hours|As the doses of 100 mg and 200 mg of OZ439 in Cohorts 1 and 2 were inadequate to eliminate the parasites and regrowth occurred, PRR calculations were only undertaken for subjects receiving 500mg of OZ439 in Cohort 3.||none (ratio)||95% Confidence Interval|Number
638068|NCT02452944|Secondary|Count the Number of Sub-divisions of Obturator Nerve at the Inguinal Crease|We checked the additional intramuscular twitching with at least 3 times more needling after block the anterior and posterior branches in both groups. And documented that twitching occurred in what kind of muscles.|up to 8 weeks|||participants|||Number
638069|NCT02452944|Primary|Success Rate of Ultrasound-guided Obturator Nerve Block With US-IFI Group and US-NS Group|"We used only the nerve stimulator for confirming the success or fail of the ONB before the surgery, so we assumed that the US-NS group had complete ONB in all patients.
In US-IFI group, complete ONB was confirmed with nerve stimulator at the end of the procedure, and if the residual twitching remained, the case was considered to be a ‘fail’."|up to 8 weeks|||participants|||Number
638070|NCT02451150|Primary|Percentage of Participants With Remarkable Findings of Clinical Concern From Baseline in Laboratory Test Results|Laboratory test results are defined as serum chemistry, hematology and urinalysis.|Baseline and Day 2|Safety population includes all participants who received at least one dose of study drug.||percentage of participants|||Number
638071|NCT02451150|Primary|Percentage of Participants With Remarkable Findings of Clinical Concern From Baseline in Resting 12-Lead Electrocardiogram (ECG)|A resting 12-lead ECG was recorded. The investigator or subinvestigator (or a qualified physician at the study site) interpreted the ECG results.|Baseline and Day 2|Safety population includes all participants who received at least one dose of study drug.||percentage of participants|||Number
638072|NCT02451150|Primary|Percentage of Participants With Remarkable Findings of Clinical Concern From Baseline in Body Weight||Baseline and Day 2|Safety population includes all participants who received at least one dose of study drug.||percentage of participants|||Number
638073|NCT02451150|Primary|Percentage of Participants With Remarkable Findings of Clinical Concern From Baseline in Vital Signs|Vital signs are defined as sitting blood pressure, sitting pulse rate and temperature.|Baseline and Day 2|Safety population includes all participants who received at least one dose of study drug.||percentage of participants|||Number
638074|NCT02451150|Primary|Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. Treatment emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event.|Up to 15 Days|Safety population includes all participants who received at least one dose of study drug.||participants|||Number
638145|NCT02448914|Secondary|Dose Adjusted AUC (0-14h) for Carbidopa||During 14 h infusion on 2 consecutive days|||h*ng/mL/mg||Full Range|Least Squares Mean
638206|NCT02446990|Secondary|Cardiovascular Mortality|Component of the primary composite endpoint|From the date of randomisation to death, up to 48 months|||participants|||Number
638075|NCT02451150|Primary|Cumulative Urinary Excretion Ratio of TAK-536 (Azilsartan) Metabolite M-II|The cumulative urinary excretion ratio (% of dose [TAK-536-equivalent]) of TAK-536 metabolite M-II will be calculated from the urinary concentration and volume of each participant.|Day 1 from 0 to 24 hours post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.||percent of dose||Standard Deviation|Mean
638076|NCT02451150|Primary|Cumulative Urinary Excretion Ratio of TAK-536 (Azilsartan) Metabolite M-I|The cumulative urinary excretion ratio (% of dose [TAK-536-equivalent]) of TAK-536 metabolite M-I will be calculated from the urinary concentration and volume of each participant.|Day 1 from 0 to 24 hours post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.||percent of dose||Standard Deviation|Mean
638077|NCT02451150|Primary|Cumulative Urinary Excretion Ratio of TAK-536 (Azilsartan)|The cumulative urinary excretion ratio (% of dose [TAK-536-equivalent]) of TAK-536 will be calculated from the urinary concentration and volume of each participant.|Day 1 from 0 to 24 hours post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.||percent of dose||Standard Deviation|Mean
638078|NCT02451150|Primary|T1/2: Terminal Elimination Half-Life of TAK-536 (Azilsartan) Metabolite M-II|T1/2 is the terminal elimination half-life (time required for half of the drug to be eliminated from the plasma), calculated as T1/2=ln(2)/λz.|Pre-dose and at multiple time points (up to 24 hours) post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.||hours||Standard Deviation|Mean
638079|NCT02451150|Primary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) of TAK-536 (Azilsartan) Metabolite M-II|Tmax is the time to reach Cmax (actual measurement value), equal to time (hours) to Cmax.|Pre-dose and at multiple time points (up to 24 hours) post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.||hours||Full Range|Median
638080|NCT02451150|Primary|AUC(0-inf) Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of TAK-536 (Azilsartan) Metabolite M-II|AUC(0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity, calculated as AUC(0-inf)=AUC(0-tlqc)+lqc/λz.|Pre-dose and at multiple time points (up to 24 hours) post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.||ng*hr/mL||Standard Deviation|Mean
638081|NCT02451150|Primary|Cmax: Maximum Observed Plasma Concentration of TAK-536 (Azilsartan) Metabolite M-II|Cmax is the maximum observed plasma concentration (actual measurement value) of a drug after administration, obtained directly from the plasma concentration-time curve.|Pre-dose and at multiple time points (up to 24 hours) post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.||ng/mL||Standard Deviation|Mean
638082|NCT02451150|Primary|AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to Time 24 Hours of TAK-536 (Azilsartan) Metabolite M-II|AUC(0-24) is a measure of total plasma exposure to the drug from time 0 to 24 hours post-dose, calculated using the linear trapezoidal rule.|Pre-dose and at multiple time points (up to 24 hours) post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.||ng*hr/mL||Standard Deviation|Mean
638083|NCT02451150|Primary|T1/2: Terminal Elimination Half-Life of TAK-536 (Azilsartan) Metabolite M-I|T1/2 is the terminal elimination half-life (time required for half of the drug to be eliminated from the plasma), calculated as T1/2=ln(2)/λz.|Pre-dose and at multiple time points (up to 24 hours) post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.||hours||Standard Deviation|Mean
638084|NCT02451150|Primary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) of TAK-536 (Azilsartan) Metabolite M-I|Tmax is the time to reach Cmax (actual measurement value), equal to time (hours) to Cmax.|Pre-dose and at multiple time points (up to 24 hours) post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.||hours||Full Range|Median
638085|NCT02451150|Primary|AUC(0-inf) Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of TAK-536 (Azilsartan) Metabolite M-I|AUC(0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity, calculated as AUC(0-inf)=AUC(0-tlqc)+lqc/λz.|Pre-dose and at multiple time points (up to 24 hours) post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.||ng*hr/mL||Standard Deviation|Mean
638086|NCT02451150|Primary|Cmax: Maximum Observed Plasma Concentration of TAK-536 (Azilsartan) Metabolite M-I|Cmax is the maximum observed plasma concentration (actual measurement value) of a drug after administration, obtained directly from the plasma concentration-time curve.|Pre-dose and at multiple time points (up to 24 hours) post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.||ng/mL||Standard Deviation|Mean
638087|NCT02451150|Primary|AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to Time 24 Hours of TAK-536 (Azilsartan) Metabolite M-I|AUC(0-24) is a measure of total plasma exposure to the drug from time 0 to 24 hours post-dose, calculated using the linear trapezoidal rule.|Pre-dose and at multiple time points (up to 24 hours) post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.||ng*hr/mL||Standard Deviation|Mean
638088|NCT02451150|Primary|T1/2: Terminal Elimination Half-Life of TAK-536 (Azilsartan)|T1/2 is the terminal elimination half-life (time required for half of the drug to be eliminated from the plasma), calculated as T1/2=ln(2)/λz.|Pre-dose and at multiple time points (up to 24 hours) post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.||hours||Standard Deviation|Mean
638089|NCT02451150|Primary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) of TAK-536 (Azilsartan)|Tmax is the time to reach Cmax (actual measurement value), equal to time (hours) to Cmax.|Pre-dose and at multiple time points (up to 24 hours) post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.||hours||Full Range|Median
638090|NCT02451150|Primary|AUC(0-inf): Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of TAK-536 (Azilsartan)|AUC(0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity, calculated as AUC(0-inf)=AUC(0-tlqc)+lqc/λz|Pre-dose and at multiple time points (up to 24 hours) post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.||ng*hr/mL||Standard Deviation|Mean
638091|NCT02451150|Primary|Cmax: Maximum Observed Plasma Concentration of TAK-536 (Azilsartan)|Cmax is the maximum observed plasma concentration (actual measurement value) of a drug after administration, obtained directly from the plasma concentration-time curve.|Pre-dose and at multiple time points (up to 24 hours) post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.||ng/mL||Standard Deviation|Mean
638092|NCT02451150|Primary|AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to Time 24 Hours of TAK-536 (Azilsartan)|AUC(0-24) is a measure of total plasma exposure to the drug from time 0 to 24 hours post-dose, calculated using the linear trapezoidal rule.|Pre-dose and at multiple time points (up to 24 hours) post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.||ng*hr/mL||Standard Deviation|Mean
638093|NCT02450799|Primary|Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at the Long-Term, Post-Implantation Visit|Measurement of best corrected (with spectacles or other visual corrective devices) visual acuity (at both near and distance). Visual Acuity (VA) is measured in logMAR (logarithm of the minimum angle of resolution). A lower logMAR value indicates better visual acuity. One eye (study eye) contributed to the analysis.|Baseline (up to and including 3 months after implantation), long-term post-implantation visit (14-20 years after implantation)|This analysis population includes all subjects who used the study devices and have data after implantation of study devices (Full Analysis Set).||logMAR||Standard Deviation|Mean
638094|NCT02450747|Primary|Average Corneal Staining Area Grade|Corneal staining Area Grade was assessed in throughout five (5) regions in the eye (Central, Nasal, Temporal, Inferior, Superior). Corneal Staining was Graded using the Efron scale from 0 to 4 in 0.1 unit steps and converted to a percentage of region that was stained. The average percent of region that was stained was calculated and reported.|Baseline to 4- Week Follow-up|The analysis population consists of all subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes.||Average Percentage of Staining|Subject Eyes|Standard Deviation|Mean
638095|NCT02450747|Primary|Upper Lid Margin Staining Score|Upper Lid Margin Staining was assessed using Fluorescein Staining and was measured on the Graded Scale is Grade 0: No Staining is present, Grade 1= 1% to 25% Stains, Grade 2= 26% to 50% Stains, Grade 3= 51% to 75% Stains, Grade 4 76% to 100% Stains. The percentage of eyes with upper lid margin staining for each Grade is reported.|Baseline to 4-Week Follow-up|The analysis population consists of all subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes.||percentage of eyes|Subject Eyes||Number
638096|NCT02450747|Primary|The Total Grade of Conjunctival Hyperemia|Hyperemia (Redness) was assessed using two different parts of the eye, the Bulbar and the Limbal. Hypemeria was measured using the Efron Scale in 0.5 step units. Grade 0= No Findings, Grade 1= Slight, Grade 2= Mild , Grade 3= Moderate and Grade 4 = severe. Hypermia was assessed in four regions of the eye (Inferior, Nasal, Temporal and Superior). The total grade of Conjunctival Hypermia across all regions and grades is reported. The total grade can range from 0 to 8. Where a higher grade implies worsening conjunctival hypermia|Baseline to 4-Week Follow-up|The analysis population consists of all subjects that completed all study visits without a major protocol deviation. The analysis is conducted on subject eyes.||units on a scale|Subject Eyes|Standard Deviation|Mean
638101|NCT02449902|Primary|Analysis of Change From Baseline to Day 15 in Investigator Assessment of the Vaginal Mucosa (Assessment of Vaginal Secretions)|Outcome was measured by using a severity scale. No Atrophy has normal clear secretions noted on vaginal walls(0). Mild atrophy has superficial coating of secretions, difficulty with speculum insertion(1). Moderate atrophy is scant not covering the entire vaginal vault, may need lubrication with speculum insertion to prevent pain(2). Severe atrophy has none, inflamed, ulceration noted, need lubrication with speculum insertion to prevent pain(3).|Baseline to 15 days post-treatment|All participants receiving at least one day of study medication.||units on a scale||Standard Error|Least Squares Mean
638102|NCT02449902|Primary|Change From Baseline to Day 15 in Investigator Assessment of the Vaginal Mucosa (Assessment of Vaginal Epithelial Surface Thickness)|Outcome was measured by using a severity scale. No Atrophy has rogation and elasticity of vault(0). Mild atrophy has poor rogation with some elasticity noted of vaginal vault(1). Moderate atrophy is smooth, some elasticity of vaginal vault(2). Severe atrophy is smooth, no elasticity, constriction of the upper one third of vagina or loss of vaginal tone (cystocele and rectocele)(3).|Baseline to 15 days post-treatment|All participants receiving at least one day of study medication.||units on a scale||Standard Error|Least Squares Mean
638200|NCT02446990|Secondary|Secondary Composite Endpoint|Fatal or non-fatal myocardial infarction|From the date of randomisation to the date of first occurrence of the event, up to 48 months|||participants|||Number
638207|NCT02446990|Secondary|All-cause Mortality||From the date of randomisation to death, up to 48 months|||participants|||Number
638103|NCT02449902|Primary|Analysis of Change From Baseline to Day 15 in Investigator Assessment of the Vaginal Mucosa (Assessment of Vaginal Epithelial Integrity)|Outcome was measured by using a severity scale. No Atrophy=normal(0). Mild atrophy=vaginal surface bleeds with scraping(1). Moderate atrophy=vaginal surface bleeds with light contact(2). Severe atrophy=vaginal surface has petechiae before contact and bleeds with light contact(3).|Baseline to 15 days post-treatment|All participants receiving at least one day of study medication.||units on a scale||Standard Error|Least Squares Mean
638104|NCT02449902|Primary|Analysis of Change From Baseline to Day 15 in Investigator Assessment of the Vaginal Mucosa (Assessment of Vaginal Color)|Outcome was measured by using a severity scale. No Atrophy is pink in color (0). Mild atrophy is lighter in color (1). Moderate atrophy is pale in color (2). Severe atrophy is transparent, either no color or inflamed (3).|Baseline to 15 days post-treatment|All participants receiving at least one day of study medication.||units on a scale||Standard Error|Least Squares Mean
638105|NCT02449902|Primary|Analysis of Change From Baseline to Day 15 in Vaginal Bleeding Associated With Sexual Activity|Total number (N=10) of participants analyzed within each treatment group who were sexually active at both Baseline and Day 15 and provided a response at both visits.|Baseline to 15 days post-treatment|Total number (N=10) of participants analyzed within each treatment group who were sexually active at both Baseline and Day 15 and provided a response at both visits.||participants|||Number
638106|NCT02449902|Primary|Analysis of Change From Baseline to Day 15 in Severity of the Most Bothersome Vulvar and Vaginal Atrophy (VVA) Symptom|The severity of the most bothersome VVA symptom was self-assessed by each subject using a VVA questionnaire. The questionnaire has a 4-point scoring scale with: None=0, Mild=1, Moderate=2, and Severe=3. The lower the score, the least bothersome it is to the subject.|Baseline to 15 days post-treatment|||units on a scale||Standard Error|Least Squares Mean
638107|NCT02449902|Primary|Analysis of Change From Baseline to Day 15 in Vaginal pH||Baseline to 15 days post-treatment|||pH||Standard Error|Least Squares Mean
638108|NCT02449902|Primary|Analysis of Change From Baseline to Day 15 in Maturation Index of the Vaginal Cell Type (Intermediate Cells)||Baseline to 15 days post-treatment|||Percentage of Intermediate Cells||Standard Error|Least Squares Mean
638109|NCT02449902|Primary|Analysis of Change From Baseline to Day 15 in Maturation Index of the Vaginal Cell Type (Superficial Cells)||Baseline to 15 days post-treatment|||Percentage of Superficial Cells||Standard Error|Least Squares Mean
638110|NCT02449902|Primary|Analysis of Change From Baseline to Day 15 in Maturation Index of the Vaginal Cell Type (Parabasal Cells)||Baseline to 15 days post-treatment|||Percentage of Parabasal Cells||Standard Error|Least Squares Mean
638111|NCT02449798|Other Pre-specified|"Number of Attempts Prior to AccuCath 2.25 Use"|Count of catheter attempts during initial insertion before patient identified as difficult IV access|Number of IV attempts made before patient identified as difficult access and enrolled in study, could range from 3-30 minutes during initial procedure attempts|||number of attempts||Full Range|Median
638112|NCT02449798|Secondary|Patient Satisfaction|A 5-point Likert scale (1-5) was used for measurement of satisfaction with overall IV performance at IV removal. A score of 1 indicated the lowest satisfaction, while a score of 5 indicated the highest satisfaction. A score of 3-5 was considered positive.|at IV removal, which can be up to a maximum of 29 days|||units on a scale||Full Range|Median
638113|NCT02449798|Secondary|Patient Satisfaction|A 5-point Likert scale (1-5) was used for measurement of satisfaction with overall IV insertion experience. A score of 1 indicated the lowest satisfaction, while a score of 5 indicated the highest satisfaction. A score of 3-5 was considered positive.|At end of IV insertion, first 3-15 minutes of procedure|||units on a scale||Full Range|Median
638114|NCT02449798|Secondary|Completion of Therapy|Count of whether the catheter lasted for the duration of intended therapy without complication requiring early removal.|During IV dwell from initial insertion success through IV removal, usually ranges from 7-14 days but could be up to 29 days|||Participants|||Count of Participants
638115|NCT02449798|Secondary|Dwell Time|IV dwell time in hours until IV is no longer needed or complicates.|Duration of IV dwell from initial insertion success through IV removal, usually ranges from 0-336 hours (0-14 days) but could be up to 696 hours (29 days)|Admitted patients||hours||Full Range|Median
638116|NCT02449798|Secondary|Complications|Count of IV complications that require IV removal before completion of therapy. Includes infiltration, extravasation, phlebitis, occlusion, dislodgement, infection, leaking at site, pain at site|During IV dwell from initial insertion success through IV removal, usually ranges from 7-14 days but could be up to 29 days|The total number of complications resulting from all 120 IV placement procedures is reported.||Complications|IV procedures||Number
638117|NCT02449798|Secondary|Time to Catheter Placement|Time will be measured from initial vessel insertion through successful cannulation|At initial IV insertion attempt through successful cannulation, generally from 3-15 minutes|||minutes||Full Range|Median
638118|NCT02449798|Primary|Number of Catheter Attempts Required to Complete Successful PIV Placement||At IV insertion attempt, generally from 3-15 minutes|||Number of Catheters||Full Range|Median
638119|NCT02449798|Primary|First Attempt Success Rate||At initial IV insertion attempt, generally from 3-15 minutes|||Participants|||Count of Participants
638120|NCT02449356|Other Pre-specified|the Incidence of Dysphonia|count the number who suffered dysphonia within the first 24 hour after extubation|within the first 24 hour after extubation|all patients in both groups were analyzed||Participants|||Count of Participants
638121|NCT02449356|Other Pre-specified|the Incidence of Sore Throat|count the number who suffer sore throat within the first 24 hour after extubation|within the first 24 hour after extubation|all patients in both groups were analyzed||Participants|||Count of Participants
638122|NCT02449356|Other Pre-specified|the Incidence of Dysphagia|count the number who suffered the dysphagia within the first 24 hours after extubation|within the first 24 hours after extubation|all patients were analyzed||Participants|||Count of Participants
638123|NCT02449356|Secondary|the Degree of Loose or Dampness of the Tape|counting and quantifying the number who occured the dampness or loose of the tape in both groups|at the time when patients were turning to supine position|all participants in both groups were analyzed||Participants|||Count of Participants
638124|NCT02449356|Secondary|The Number of the Prolapse of Endotracheal Tube|Counting the number who occured the prolapse of endotracheal tube in both groups|At any time within the procedure of the whole surgery|All participants in both groups were analyzed||Participants|||Count of Participants
638125|NCT02449356|Primary|Displacement of the Endotracheal Tube|We divided the degree of the displacement of the endotracheal tube into 3 kinds, which included mild(displacement distance＜0.5cm),moderate(0.5cm≤displacement distance＜1.5cm),severe (1.5cm≤displacement distance).|Participants were followed for the duration of surgery, an average of 2 hours.|All patients in each group were analyzed||Participants|||Count of Participants
638126|NCT02449044|Secondary|Change From Baseline in the Hyponatremia Disease-specific Survey|Analysis of individual items of Hyponatremia Disease-specific Survey was not conducted, because the analysis of Hyponatremia Disease-specific Survey was focused on the PCS and MCS summary scores since these 2 scores were developed. Subgroup analyses of Hyponatremia Disease-specific Survey were also not conducted.|Baseline to Week 214|The Hyponatremia Disease-specific Survey PCS and MCS scores evaluated during the trial were variable with only nominal changes from baseline observed. The data were collected under 2 different datasets, so the number of participants in each dataset was reduced that limited analysis of this endpoint.|||||
638127|NCT02449044|Secondary|Mean Change From Baseline in SF-12 (Health Survey) Mental Component Summary (MCS)|The MCS assess the physical and mental dimensions of health-related quality of life. The MCS is equal to the sum of the items of concentration activities, calculating activities, language activities, and memory activities. The MCS is a computed score with weighted function based on the 12 questions from the 8 subscales (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, mental health) of the SF-12v1 questionnaire per instructions by the scale’s publisher. The scale ranges from 0 to 100 with 0 representing the lowest level of health and 100 indicating the highest level of health.|Baseline to Week 214|The ITT dataset comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit were analyzed. In the last observation carried forward (LOCF) dataset, missing data were filled in using the participant's preceding non-missing value, except that Baseline value will not be carried forward.||Units on a scale||Standard Deviation|Mean
638128|NCT02449044|Secondary|Mean Change From Baseline in SF-12 (Health Survey) Physical Component Summary (PCS)|The PCS assess the physical and mental dimensions of health-related quality of life. The PCS is equal to the sum of the items of endurance activities, strength activities, gross coordination activities, and fine coordination activities. The PCS is a computed score with weighted function based on the 12 questions from the 8 subscales (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, mental health) of the SF-12v1 questionnaire per instructions by the scale’s publisher. The scale ranges from 0 to 100 with 0 representing the lowest level of health and 100 indicating the highest level of health.|Baseline to Week 214|The ITT dataset comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit were analyzed. In the last observation carried forward (LOCF) dataset, missing data were filled in using the participant's preceding non-missing value, except that Baseline value will not be carried forward.||Units on a scale||Standard Deviation|Mean
638129|NCT02449044|Secondary|Mean Change From Baseline in Body Weight by Visit for Those Participants Who Had Clinical Evidence of Hypervolemia at Baseline|Body weight at each visit (assessed only for those with clinical evidence of hypervolemia at Baseline) and was summarized using descriptive statistics.|Baseline to Week 214|The ITT dataset comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit were analyzed. The observed cases (OC) dataset consisted of only data points obtained from participants who were evaluated at the visit, without missing study drug consecutively for 14 days.||kg||Standard Deviation|Mean
638130|NCT02449044|Secondary|Percentage of Participants Requiring Prescription of Other Medicines|Percentage of participants requiring prescription of other medicines for the express purpose of treating hyponatremia during each period of the trial, assessed descriptively at each visit.|Baseline to Post-Week 214 follow-up visit|The ITT dataset, which comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit, were analyzed. Percentage of participants requiring other medicines such as demeclocycline or urea was not analyzed.||percentage of participants|||Number
638131|NCT02449044|Secondary|Number of Participants Requiring Prescription of Hypertonic Saline|Percentage of participants requiring prescription of hypertonic saline for the express purpose of treating hyponatremia during each period of the trial, assessed descriptively at each visit.|Baseline to Post-Week 214 follow-up visit|The ITT dataset, which comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit, were analyzed. Percentage of participants requiring prescription of hypertonic saline was not analyzed due to a low number of participants who received the treatment.||participants|||Number
638132|NCT02449044|Secondary|Percentage of Participants Requiring Prescription of Fluid Restriction|Percentage of participants requiring prescription of fluid restriction for the express purpose of treating hyponatremia during each period of the trial. Assessed descriptively at each visit.|Baseline to Post-Week 214 follow-up visit|The ITT dataset, which comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit, were analyzed. In the last observation carried forward (LOCF) dataset, missing data were filled in using the participant's preceding non-missing value, except that Baseline value will not be carried forward.||percentage of participants|||Number
638133|NCT02449044|Secondary|Change From Baseline in Percentage of Participants With Normal Sodium Levels|Percentage of participants with varying degrees of hyponatremia (“severe” <130, “mild” 130-135, “normal” >135 mEq/L) at Baseline and each study visit.|Baseline to Week 214|The ITT dataset, which comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit, were analyzed. In the last observation carried forward (LOCF) dataset, missing data were filled in using the participant's preceding non-missing value, except that Baseline value will not be carried forward.||percentage of participants|||Number
638134|NCT02449044|Secondary|Change From Baseline in Percentage of Participants With Mild Hyponatremia|Percentage of participants with varying degrees of hyponatremia (“severe” <130, “mild” 130-135, “normal” >135 mEq/L) at Baseline and each study visit.|Baseline to Week 214|The ITT dataset, which comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit, were analyzed. In the last observation carried forward (LOCF) dataset, missing data were filled in using the participant's preceding non-missing value, except that Baseline value will not be carried forward.||percentage of participants|||Number
643917|NCT02224820|Secondary|Safety|Adverse events (all clinical laboratory tests, vital signs and ECG jugded as clinically significant were reported as AEs)|9 weeks|||Adverse events|||Number
638135|NCT02449044|Secondary|Change From Baseline in Percentage of Participants With Severe Hyponatremia|Percentage of participants with varying degrees of hyponatremia (“severe” <130, “mild” 130-135, “normal” >135 mEq/L) at Baseline and each study visit.|Baseline to Week 214|The ITT dataset, which comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit, were analyzed. In the last observation carried forward (LOCF) dataset, missing data were filled in using the participant's preceding non-missing value, except that Baseline value will not be carried forward.||percentage of participants|||Number
638136|NCT02449044|Secondary|Mean Change From Baseline in Serum Sodium Measurements|Sodium measurements obtained at designated intervals were compared to each participant's Baseline sodium level at the beginning of placebo-controlled therapy in their original trial and from Baseline on initiation of therapy in the open-label trial.|Baseline of parent trial to Week 214|The ITT dataset, which comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit, were analyzed. In the last observation carried forward (LOCF) dataset, missing data were filled in using the participant's preceding non-missing value, except that Baseline value will not be carried forward.||mEq/L||Standard Deviation|Mean
638137|NCT02449044|Primary|Participants With Body Weight Abnormalities Reported as TEAEs|The body weight evaluation was one of the primary parameters to measure the safety and tolerability of individual participants. Every effort was made to ensure that body weight measurements were performed in a reproducible and consistent manner. The pre-defined criteria was change of ≥7% in body weight for both male and female. Participants were to wear the same type of clothes at each measurement, preferably a gown and no shoes. All body weight measurements were to have been taken post-void.|Baseline to Post-Week 214 follow-up visit|The ITT dataset, which comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit, were analyzed.||participants|||Number
638138|NCT02449044|Primary|Participants With Vital Signs Abnormalities Reported as Treatment Emergent Adverse Events (TEAEs)|The vital signs were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance included abnormal values in body temperature, heart rate, systolic and diastolic blood pressure, respiratory rate and weight that were identified based on pre-defined criteria. Criteria for identifying vital signs of potential clinical relevance included: Heart rate, supine: >= 120 beats per minute (bpm) + increase of ≥15 bpm from Baseline and <=50 bpm + decrease of >= 15 bpm; Diastolic Blood Pressure, Supine: >=105 mmHg + increase of >=15 mmHg and <=50 mmHg + decrease of >=15 mmHg; Systolic Blood Pressure, Supine: >=180 mmHg + increase of >=20 mmHg and <= 90 mmHg + decrease of >=20 mmHg; Temperature (degree C): Increase of >=1.1 to >=38.3C. The vital sign abnormalities were reported as TEAEs are mentioned below.|Baseline to Post-Week 214 follow-up visit|The intent-to-treat (ITT) dataset, which comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit, were analyzed.||participants|||Number
638139|NCT02449044|Primary|Participants With Electrocardiogram (ECG) Related Abnormalities Reported as TEAEs|The ECG was one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance included abnormal values in HR outliers, PR outliers, QRS outliers, QT, QTcB, QTcF that were identified based on pre-defined criteria. Some of the pre-defined criteria for identifying ECG measurements of potential clinical relevance included: For QTcB and QTcF: baseline mean of QTcB and QTcF interval was new onset >500 msec, 30 - 60 msec, >60 msec; For QT: new onset >500 msec; For QRS outliers: >=25% change from baseline when QRS >100 msec; PR outliers: >=25% change from baseline when PR>200 msec; HR outliers: 25% decrease from baseline and HR <50 bpm or 25% increase from baseline and HR >100 bpm. New onset (>500 msec) in QT, QTcB, or QTcF means a participant who attained a value >500 msec during treatment period but not at each baseline visit. The ECG-related abnormalities are reported as TEAEs are mentioned below.|Baseline to Post-Week 214 follow-up visit|The ITT dataset, which comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit, were analyzed.||participants|||Number
638140|NCT02449044|Primary|Participants With Laboratory Values Abnormalities Reported as TEAEs|The laboratory values were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal values in serum chemistry, hematology, urinalyses and prolactin tests that were identified based on pre-defined criteria. Any value outside the normal range was flagged for the attention of the study physician who was to indicate whether the value was clinically significant for identifying laboratory values of potential clinical relevance. Participants noted with abnormal laboratory values are reported below.|Baseline to Post-Week 214 follow-up visit|The ITT dataset, which comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit, were analyzed.||participants|||Number
638141|NCT02449044|Primary|Participants With Adverse Events (AEs)|A TEAE was an AE that began after the first injection or was continuous from Baseline and was defined as any new medical problem, or exacerbation of an existing problem, whether or not it was considered drug-related by the study physician. An AE was considered serious if it was fatal; life-threatening; persistently or significantly disabling or incapacitating; required in-subject hospitalization or prolonged hospitalization; a congenital anomaly/birth defect; or other medically significant event that, based upon appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention to prevent the outcomes mentioned above.|Baseline to Post-Week 214 follow-up visit|The ITT dataset, which comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit, were analyzed.||participants|||Number
638142|NCT02448914|Other Pre-specified|Treatment Response Scale (ON/OFF Effect) - Mean % of Time Patients Were in Functional ON State During 3-14 h|Dyskinesia and parkinsonism symptoms were evaluated throughout the study period as an assessment of the clinical response. To assess the ON/OFF effect the Treatment Response Scale (TRS) was used. The TRS ranges from -3 (severe “OFF”) to +3 (“ON” with severe dyskinesia). Results from the TRS recordings are presented as the mean percentage of time patients were in functional ON state (TRS: -1 to +1) during the time interval 3-14 h.|TRS assessments were made every 30 minutes from start of study drug administration until 3 h, every hour between 3 and 14 h and every 30 minutes between 14 and 17 h.|||Mean % of time||Full Range|Mean
638143|NCT02448914|Secondary|Dose Adjusted AUC (0-14h) for 3-O-Methyldopa||During 14 h infusion on 2 consecutive days|||h*ng/mL/mg||Full Range|Least Squares Mean
673112|NCT01664975|Secondary|Overall Survival||up to the date of death (approximately 5 years)||09/2016||||
638146|NCT02448914|Secondary|Intra-individual Coefficient of Variation (3-14h) for Levodopa|The individual patient’s coefficient of variation (CV) of levodopa plasma concentration during administration of TRIGEL and Duodopa respectively between 3 and 14 h after start of study drug. CV=100*sqrt (exp (SDlog*SDlog)-1) were SDlog denotes the standard deviation computed on logged plasma concentrations.|During 3-14h infusion on 2 consecutive days|||percentage of variability||Full Range|Least Squares Mean
638147|NCT02448914|Primary|Dose Adjusted Area Under the Curve (AUC) (0-14h) for Levodopa||During 14 h infusion on 2 consecutive days|||h*ng/mL/mg||Full Range|Least Squares Mean
638148|NCT02448862|Secondary|Incidence of Dizziness or Headaches|The percentage of participants who had headache and dizziness|Postoperative 48 hours|||percentage of participants|||Number
638149|NCT02448862|Secondary|Incidence of Nausea and Vomiting|The percentage of participants who had nausea and vomiting during postoperative 48 hours|Postoperative 48 hours|||percentage of participants|||Number
638150|NCT02448862|Secondary|Postoperative Pain in Numeric Pain Scale|The Numeric Pain Scale (NRS - 0: no pain, 10: worst pain can't imagine) for pain measured once at each time periods (0~6, 6~12, 12~18, 18~24, 24~48 hours)|Postoperative 48 hours|||Scores on a scale||Standard Deviation|Mean
638151|NCT02448862|Primary|Incidence of Rescue Antiemetics Requirement|The proportion of patients who required rescue antiemetics at least once during the postoperative 48-hour period|Postoperative 48 hours|||Percentage of Participants|||Number
638152|NCT02448862|Primary|Incidence of Rescue Analgesics Requirement|The percentage of patients who required rescue analgesics at least once during the postoperative 48-hour period|Postoperative 48 hours|||Percentage of Participants|||Number
638153|NCT02448563|Secondary|Waist Circumference at 8 Weeks||8 weeks|||centimeters||Standard Deviation|Mean
638154|NCT02448563|Secondary|Changes in Baseline Physical Activity to 8 Weeks as Measured by the Kaiser Physical Activity Scale|Activity indices were created for each domain of activity (household/caregiving, occupational, active living, sports/exercise) by summing the domain-specific categorical responses and dividing by the number of items, giving an average value that ranged from 1 to 5. We summed the scores of the component items that comprised each scale (and higher scores are those where respondents are more likely to strongly agree). What is reported in the tables are the differences in raw scores computed by subtracting the summed scores at Baseline from that measured at 8 weeks (difference = 8 weeks score – baseline score).|Baseline and 8 weeks|||units on a scale||Standard Error|Mean
638155|NCT02448563|Secondary|Changes in Baseline Body Image to 8 Weeks as Measured by the 34-item Multidimensional Body Relations Questionnaire|The Multidimensional Body Relations Questionnaire (MBSRQ-AS) includes the following subscales: Appearance Evaluation, Appearance Orientation, Overweight Preoccupation, Self-Classified Weight, and the Body Areas Satisfaction Scale (BASS). We summed the scores of the component items that comprised each scale (and higher scores are those where respondents are more likely to strongly agree). What is reported in the tables are the differences in raw scores computed by subtracting the summed scores at baseline from that measured at 8 weeks (difference = 8 weeks score – Baseline score). Scale ranges from 1-5 (1=definitely disagree, 2=mostly disagree, 3=neither agree nor disagree, 4=mostly agree, 5=definitely agree) with higher scores reflecting better outcome. A positive value shows improvement in that subscale over time.|Baseline and 8 weeks|||units on a scale||Standard Error|Mean
638156|NCT02448563|Secondary|Changes in Baseline Eating Behaviors to 8 Weeks as Measured by Eating Behavior Patterns Questionnaire|Items were rated on a 5 point scale (1 strongly disagree, 2 disagree, 3 neutral or not applicable, 4 agree, 5 strongly agree). We summed the scores of the component items that comprised each scale (and higher scores are those where respondents are more likely to strongly agree). What is reported in the tables are the differences in raw scores computed by subtracting the summed scores at baseline from that measured at 8 weeks (difference = 8 weeks score – Baseline score).|Baseline and 8 weeks|||z-score||Standard Error|Mean
638157|NCT02448563|Secondary|Participant Satisfaction as Measured by Questionnaire and Exit Interview||8 weeks|||Percentage|||Number
638158|NCT02448563|Secondary|Change From Baseline Weight to 8 Weeks||Baseline and 8 weeks|||kilograms||Standard Error|Mean
638159|NCT02448563|Primary|Feasibility as Measured by Attendance at Group Sessions and Barriers to Attendance (Logs Kept by Research Staff)||Weekly up to 8 weeks|||participants|||Number
638160|NCT02447458|Secondary|Renal Clearance (CLr) of MLN3126 and Metabolite M-I|Renal clearance was calculated as CLr=Ae(0-96)/AUC (0-96).|Pre-dose and multiple timepoints post-dose (Up to 96 Hours)|PK analysis set included all participants who received study drug and who had at least 1 measurable PK urine concentration.||mL/min||Standard Deviation|Mean
638161|NCT02447458|Secondary|Fe: Fraction of MLN3126 Excreted in the Urine|Fe is the Fraction of drug excreted in urine, calculated as Fe=(Ae[0-t]/dose)×100.|Pre-dose and multiple timepoints post-dose (Up to 96 Hours)|PK analysis set included all participants who received study drug and who had at least 1 measurable PK urine concentration.||Percentage||Standard Deviation|Mean
638162|NCT02447458|Secondary|Ae (0-96): Total Amount of MLN3126 and Metabolite M-I Excreted in the Urine|Ae (0-96) is the total amount of drug excreted in urine from time 0 to time 96 hours.|Pre-dose and multiple timepoints post-dose (Up to 96 Hours)|PK analysis set included all participants who received study drug and who had at least 1 measurable PK urine concentration.||ng||Standard Deviation|Mean
638163|NCT02447458|Secondary|T ½: Half-life of MLN3126 and Metabolite M-I|Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.|Pre-dose and multiple timepoints post-dose (Up to 96 Hours)|PK analysis set included all participants who received study drug and who had at least 1 measurable PK plasma concentration.||Hours||Standard Deviation|Mean
638164|NCT02447458|Secondary|CL/F: Oral Clearance of MLN3126|CL/F is apparent clearance of the drug from the plasma, after extravascular administration.|Pre-dose and multiple timepoints post-dose (Up to 96 Hours)|PK analysis set included all participants who received study drug and who had at least 1 measurable PK plasma concentration.||L/hr||Standard Deviation|Mean
638165|NCT02447458|Secondary|AUC(0-inf): Area Under the Plasma Concentration Time Curve of MLN3126 and Metabolite M-I From Time 0 to Infinity|AUC(0-inf) is measure of area under the curve from time 0 to infinity.|Pre-dose and multiple timepoints post-dose (Up to 96 Hours)|PK analysis set included all participants who received study drug and who had at least 1 measurable PK plasma concentration.||ng*hr/mL||Standard Deviation|Mean
638201|NCT02446990|Secondary|Coronary Revascularisation (Elective or Not)|Non-composite secondary endpoint|From the date of randomisation to the date of first occurrence of the event, up to 48 months|||participants|||Number
638166|NCT02447458|Secondary|AUC(0-tlqc): Area Under the Plasma Concentration Time Curve of MLN3126 and Metabolite M-I From Time 0 to the Last Quantifiable Concentration|AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]).|Pre-dose and multiple timepoints post-dose (Up to 96 Hours)|PK analysis set included all participants who received study drug and who had at least 1 measurable PK plasma concentration.||ng*hr/mL||Standard Deviation|Mean
638167|NCT02447458|Secondary|Tmax: Time to Maximum Plasma Concentration of MLN3126 and Metabolite M-I|Tmax is the time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.|Pre-dose and multiple timepoints post-dose (Up to 96 Hours)|PK analysis set included all participants who received study drug and who had at least 1 measurable PK plasma concentration.||Hours||Full Range|Median
638168|NCT02447458|Secondary|Cmax: Maximum Plasma Concentration of MLN3126 and Metabolite M-I|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Pre-dose and multiple timepoints post-dose (Up to 96 Hours)|Pharmacokinetic (PK) analysis set included all participants who received study drug and who had at least 1 measurable PK plasma concentration.||ng/mL||Standard Deviation|Mean
638169|NCT02447458|Primary|Percentage of Participants With Markedly Abnormal Electrocardiogram (ECG) Findings Post-Dose|A standard 12-lead ECG was performed. The percentage of participants with markedly abnormal electrocardiogram (ECG) findings during the study.|Up to Day 16|Safety population included all enrolled participants who received at least 1 dose of study drug.||Percentage of Participants|||Number
638170|NCT02447458|Primary|Percentage of Participants With Markedly Abnormal Vital Signs Post-Dose|Vital signs included oral body temperature measurement, blood pressure, respiration rate, and pulse rate [beats per minute (bpm) or heart rate]. The percentage of participant with markedly abnormal vital signs findings during the study. OBP=Orthostatic Blood Pressure. All OBP measurements were standing.|Up to Day 16|Safety population included all enrolled participants who received at least 1 dose of study drug.||Percentage of Participants|||Number
638171|NCT02447458|Primary|Percentage of Participants With Markedly Abnormal Clinical Laboratory Results Post-Dose|Clinical safety laboratory tests included clinical chemistry, hematology and urinalysis. The percentage of participants with any markedly abnormal laboratory finding during the study.|Up to Day 16|Safety population included all enrolled participants who received at least 1 dose of study drug.||Percentage of Participants|||Number
638172|NCT02447458|Primary|Number of Participants That Experience At Least One Treatment-Emergent Adverse Event (TEAE) Post-Dose|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|Up to Day 22|Safety population included all enrolled participants who received at least 1 dose of study drug.||Participants|||Number
638173|NCT02447432|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs) During the Entire Duration of the Study|An SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization, as per the medical or scientific judgement of the physician. Any = Occurrence of an SAE, regardless of relationship to vaccination.|From Day 0 to Month 9|The analysis was performed on the Total vaccinated cohort of Epoch 001 which included all subjects who had received at least one dose of primary vaccination.||Participants|||Count of Participants
638174|NCT02447432|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs) (Epoch 001)|An SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization, as per the medical or scientific judgement of the physician. Any = Occurrence of an SAE, regardless of relationship to vaccination.|From Month 0 to Month 4|The analysis was performed on the Total vaccinated cohort of Epoch 001 which included all subjects who had received at least one dose of primary vaccination.||Participants|||Count of Participants
638175|NCT02447432|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs) (Epoch 002)|An unsolicited AE was defined as any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination.|Within the 31-day (Days 0-30) period post booster vaccination|The analysis was performed on the Total vaccinated cohort of Epoch 002 included all subjects who had received the booster vaccination, with analysis done solely on subjects for whom post-vaccination results about solicited or unsolicited symptoms were available.||Participants|||Count of Participants
638176|NCT02447432|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs) (Epoch 001)|An unsolicited AE was defined as any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination.|Within the 31-day (Days 0-30) period post primary vaccination, across doses|The analysis was performed on the Total vaccinated cohort of Epoch 001 which included all subjects who had received at least one dose of primary vaccination.||Participants|||Count of Participants
638177|NCT02447432|Secondary|Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination (Epoch 002)|Assessed solicited general symptoms were Drowsiness, Irritability/Fussiness, Loss of appetite and Fever (axillary route - temperature equal or higher than [≥] 37.5 degrees Celsius [°C]). Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irritability/Fussiness = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = (Axillary) temperature higher than (>) 39.5°C.|Within the 4-day (Days 0-3) period after booster vaccination|The analysis was performed on the Total vaccinated cohort of Epoch 002 included all subjects who had received the booster vaccination, with analysis done solely on subjects for whom post-vaccination results about solicited or unsolicited symptoms were available.||Participants|||Count of Participants
638178|NCT02447432|Secondary|Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001)|"Assessed solicited general symptoms were Drowsiness, Irritability/Fussiness, Loss of appetite and Fever (axillary route - temperature equal or higher than [≥] 37.5 degrees Celsius [°C]). Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irritability/Fussiness = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = (axillary) temperature higher than (>) 39.5°C. Related = Occurrence of the specified symptom assessed by the investigator as causally related to vaccination. Dose 1 = 10Pn-PD-DIT+DTPw-HBV/Hib at 6 weeks of age. Dose 2 = 10Pn-PD-DIT+DTPw-HBV/Hib at 10 weeks of age.
Dose 4 = 10Pn-PD-DIT at 18 weeks of age."|Within the 4-day (Days 0-3) post-vaccination period following each primary dose of 10Pn-PD-DiTvaccine|The analysis was performed on the Total vaccinated cohort of Epoch 001 included all subjects who had received at least one dose of primary vaccination, with analysis done solely on subjects for whom post-vaccination results about solicited symptoms were available.||Participants|||Count of Participants
638179|NCT02447432|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 002)|Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm).|Within the 4-day (Days 0-3) period after booster vaccination|The analysis was performed on the Total vaccinated cohort of Epoch 002 included all subjects who had received the booster vaccination, with analysis done solely on subjects for whom post-vaccination results about solicited or unsolicited symptoms were available.||Participants|||Count of Participants
638180|NCT02447432|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 001)|"Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm). Dose 1 = 10Pn-PD-DIT+DTPw-HBV/Hib at 6 weeks of age. Dose 2 = 10Pn-PD-DIT+DTPw-HBV/Hib at 10 weeks of age.
Dose 4 = 10Pn-PD-DIT at 18 weeks of age."|Within the 4-day (Days 0-3) post-vaccination period following each primary dose of 10Pn-PD-DiTvaccine|The analysis was performed on the Total vaccinated cohort of Epoch 001 included all subjects who had received at least one dose of primary vaccination, with analysis done solely on subjects for whom post-vaccination results about solicited symptoms were available.||Participants|||Count of Participants
638181|NCT02447432|Secondary|Concentrations of Antibodies Against Protein D (Anti-PD) (Epoch 002)|Anti-PD antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The cut-off of the assay was an anti-PD antibody concentration higher than or equal to (≥) 153 EL.U/mL.|At study Month 9, e.g.: at one month post booster vaccination with pneumococcal vaccine|The analysis was performed on the According To Protocol cohort for immunogenicity of Epoch 002 which included all evaluable subjects (i.e., those meeting eligibility criteria, complied with procedures and intervals defined in protocol, with no elimination criteria) for whom data concerning booster immunogenicity outcomes measures were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
638182|NCT02447432|Secondary|Concentrations of Antibodies Against Protein D (Anti-PD) (Epoch 001)|Anti-PD antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The cut-off of the assay was an anti-PD antibody concentration higher than or equal to (≥) 153 EL.U/mL.|At study Month 4, e. g. at one month post-Dose 3 of pneumococcal vaccine|The analysis was performed on the According To Protocol cohort for immunogenicity of Epoch 001 which included all evaluable subjects (i.e., those meeting eligibility criteria, complied with procedures and intervals defined in protocol, with no elimination criteria) for whom data concerning primary immunogenicity outcomes measures were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
638183|NCT02447432|Secondary|Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002)|Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (OPA-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8.|At study Month 8 and Month 9, e.g.: prior to and at one month post booster vaccination with pneumococcal vaccine|The analysis was performed on the According To Protocol cohort for immunogenicity of Epoch 002 which included all evaluable subjects (i.e., those meeting eligibility criteria, complied with procedures and intervals defined in protocol, with no elimination criteria) for whom data concerning booster immunogenicity outcomes measures were available.||Titers||95% Confidence Interval|Geometric Mean
638202|NCT02446990|Secondary|Elective Coronary Revascularisation|Non-composite secondary endpoint|From the date of randomisation to the date of first occurrence of the event, up to 48 months|||participants|||Number
638203|NCT02446990|Secondary|Non-fatal Myocardial Infarction|Component of the primary composite endpoint|From the date of randomisation to the date of first occurrence of the event, up to 48 months|||participants|||Number
638204|NCT02446990|Secondary|Fatal Myocardial Infarction|Non-composite secondary endpoint|From the date of randomisation to death, up to 48 months|||participants|||Number
638184|NCT02447432|Secondary|Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 001)|Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (OPA-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, 19 A ,-19F and -23F). The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8.|At study Month 4, e. g. at one month post-Dose 3 of pneumococcal vaccine|The analysis was performed on the According To Protocol cohort for immunogenicity of Epoch 001 which included all evaluable subjects (i.e., those meeting eligibility criteria, complied with procedures and intervals defined in protocol, with no elimination criteria) for whom data concerning primary immunogenicity outcomes measures were available.||Titers||95% Confidence Interval|Geometric Mean
638185|NCT02447432|Secondary|Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002)|Antibodies assessed for this outcome measure were those against the vaccine/cross-reactive pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F-inhibition enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL.|At Month 8 and Month 9, e.g.: prior to and at one month post booster vaccination with pneumococcal vaccine|The analysis was performed on the According To Protocol cohort for immunogenicity of Epoch 002 which included all evaluable subjects (i.e., those meeting eligibility criteria, complied with procedures and intervals defined in protocol, with no elimination criteria) for whom data concerning booster immunogenicity outcomes measures were available.||µg/mL||95% Confidence Interval|Geometric Mean
638186|NCT02447432|Primary|Antibody Concentrations Against Pneumococcal Serotypes (Epoch 001)|Antibodies assessed for this outcome measure were those against the vaccine/cross-reactive pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F-inhibition enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. Primary outcome results correspond to antibody concentrations for the 10 vaccine serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.|At study Month 4, e. g. at one month post-Dose 3 of pneumococcal vaccine|The analysis was performed on the According To Protocol cohort for immunogenicity of Epoch 001 which included all evaluable subjects (i.e., those meeting eligibility criteria, complied with procedures and intervals defined in protocol, with no elimination criteria) for whom data concerning primary immunogenicity outcomes measures were available.||µg/mL||95% Confidence Interval|Geometric Mean
638187|NCT02447133|Primary|TopQ Cut Off|To validate the values of the predetermined TopQ score by showing the variability above and below the TopQ score of 25 for 12x9 Wide, 28 for 6x6 Macula, and 30 for 6x6 Disc scans.|1 hour|use of 12 subjects for 3 different scan patterns||microns|||Number
638188|NCT02447029|Secondary|Overall Complication Rate as Measured by a Count of Participants in Each Group||Rate of complications at the end of the study|All treated patients were analyzed||Participants|||Count of Participants
638189|NCT02447029|Secondary|Overall Satisfaction With Procedure as Measured by a Visual Analog Scale|This is the level of overall satisfaction self-reported by the patient at the completion of the procedure and prior to discharge. VAS ranged from 0 to 100 mm, 0 equals not satisfied, 100 equals highest satisfaction possible.|30-45 minutes after completion of procedure|All treated patients were included in the analysis||units on a scale||Inter-Quartile Range|Median
638190|NCT02447029|Secondary|Pain 30-45 Minutes After Procedure as Measured by a Visual Analog Scale|This is the amount of pain self-reported by the patient 30-45 minutes after procedure. VAS ranged from 0 to 100 mm, 0 equals no pain, 100 equals worse pain imaginable.|Pain prior to discharge home: 30-45 minutes after completion of procedure|All treated patients were included in the analysis||units on a scale||Inter-Quartile Range|Median
638191|NCT02447029|Secondary|Pain With Tenaculum Placement as Measured by a Visual Analog Scale|This is the amount of pain self-reported by the patient at the time of tenaculum placement. VAS ranged from 0 to 100 mm, 0 equals no pain, 100 equals worse pain imaginable.|Pain at time of tenaculum placement|All treated patients were included in the analysis||units on a scale||Standard Deviation|Mean
638192|NCT02447029|Secondary|Pain With Speculum Insertion as Measured by a Visual Analog Scale|This is the amount of pain self-reported by the patient at the time of speculum insertion. VAS ranged from 0 to 100 mm, 0 equals no pain, 100 equals worse pain imaginable.|Pain at time of speculum insertion|Treated patients were included in the analysis||units on a scale||Standard Deviation|Mean
638193|NCT02447029|Secondary|Pain Level Prior to Procedure (Anticipated Pain) as Measured by a Visual Analog Scale|This is the amount of pain self-reported by the patient prior to the procedure (Anticipated pain). VAS ranged from 0 to 100 mm, 0 equals no pain, 100 equals worse pain imaginable.|Pain level prior to procedure|Treated patients were included in the analysis||units on a scale||Inter-Quartile Range|Median
638194|NCT02447029|Primary|Difference in Pain Level at Time of Cervical Dilation as Measured by a Visual Analog Scale|This is the amount of pain self-reported by the patient at the time of cervical dilation. VAS ranged from 0 to 100 mm, 0 equals no pain, 100 equals worse pain imaginable.|At time of cervical dilation, 30 minutes after lidocaine administration|Treated participants were included in the analysis.||units on a scale||Inter-Quartile Range|Median
638195|NCT02446990|Secondary|Secondary Composite Endpoint|Non-fatal myocardial infarction, coronary revascularisation, unstable angina|From the date of randomisation to the date of first occurrence of the event, up to 48 months|||participants|||Number
638196|NCT02446990|Secondary|Secondary Composite Endpoint|Coronary death, non-fatal myocardial infarction|From the date of randomisation to the date of first occurrence of the event, up to 48 months|||participants|||Number
638197|NCT02446990|Secondary|Secondary Composite Endpoint|Cardiovascular death, non-fatal myocardial infarction, non-fatal stroke|From the date of randomisation to the date of first occurrence of the event, up to 48 months|||participants|||Number
638198|NCT02446990|Secondary|Secondary Composite Endpoint|Fatal or non-fatal myocardial infarction, coronary revascularisation, unstable angina|From the date of randomisation to the date of first occurrence of the event, up to 48 months|||participants|||Number
638199|NCT02446990|Secondary|Secondary Composite Endpoint|Fatal or non-fatal myocardial infarction, coronary revascularisation|From the date of randomisation to the date of first occurrence of the event, up to 48 months|||participants|||Number
638208|NCT02446990|Primary|Primary Composite Endpoint|First event among cardiovascular death or non-fatal myocardial infarction|The events are expressed as the time to occurrence of the first event, defined as the duration between the date of randomisation and the date of first occurrence of event, assessed up to 48 months.|||participants|||Number
638209|NCT02446717|Secondary|Percentage of Participants With Post-treatment Relapse|Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants with HCV RNA levels < LLOQ at the end of treatment, excluding reinfection.|From the end of treatment through 12 weeks after the last dose of study drug|All participants who received at least 1 dose of study drug, completed treatment, and had HCV RNA <LLOQ at the final treatment visit.||percentage of participants||95% Confidence Interval|Number
638210|NCT02446717|Secondary|Percentage of Participants With On-treatment Virologic Failure|On-treatment virologic failure was defined as confirmed HCV RNA ≥ 100 IU after HCV RNA < LLOQ during treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.|Day 3, Treatment Weeks 1, 2, 4, 6, 8, 10, 12 (end of treatment for 12-week treatment arms), and 16 (end of treatment for 16-week treatment arm) or premature discontinuation from treatment|All participants who received at least 1 dose of study drug (ITT population)||percentage of participants||95% Confidence Interval|Number
638211|NCT02446717|Secondary|Percentage of Participants With Sustained Virologic Response 4 Weeks Post-treatment (SVR4)|SVR4 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 4 weeks after the last dose of study drug.|4 weeks after the last actual dose of study drug|All participants who received at least 1 dose of study drug (ITT population); participants with missing data after backwards imputation were imputed as nonresponders.||percentage of participants||95% Confidence Interval|Number
638212|NCT02446717|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of study drug|Intent-to-treat population: all participants who received at least 1 dose of study drug; participants with missing data after backwards imputation were imputed as nonresponders.||percentage of participants||95% Confidence Interval|Number
638213|NCT02446613|Secondary|Mean Change From Baseline in Individual Nasal Sym. Including Sneezing, Nasal Congestion, Rhinorrhoea and Nasal Itch.|Four individual nasal sym. including nasal congestion, rhinorrhoea, nasal itch and sneezing were recorded at Baseline (pre-NAC) and at post-NAC 15, 30 min, 1, 2, 3, 4, 5, 6h. Participants rated sym. on a 4-point scale. For nasal blockage and congestion the scores were (0= Breathing through nose freely and easily, 1= Slight difficulty breathing through nose, 2= Moderate difficulty breathing through nose and 3= Severe difficulty breathing through nose). For rhinorrhoea, nasal itching and sneezing (0= None: No sym. whatsoever; Absent, 1= Mild: Sym. is present, noticeable but not bothersome, 2= Moderate: Sym. is bothersome, but tolerable and 3= Severe: Sym. which are bothersome, harder to tolerate). The baseline value were the latest pre-dose assessments. Mean change from Baseline at 15 min, WM0-1h, WM 0-6h, and maximum change over 0-6 h were reported. Change from Baseline was measured as the value recorded at a specified time point minus Baseline value.|Day 1 (Baseline [pre-NAC] to post-NAC 6 h)|Safety population||Score on a scale||Standard Deviation|Mean
638214|NCT02446613|Primary|Maximum Percent Change From Baseline in PINF Over Post-NAC 6 h|PNIF data recorded at Baseline pre-challenge and at 15, 30 min, 1, 2, 3, 4, 5, 6h. The percent change from Baseline and at specified time point was derived by the formula (PNIF at Baseline minus PNIF at Post-NAC specified time point) divided by PNIF at Baseline) multiplied by 100. The baseline values were the latest pre-dose assessments. Percent change in PNIF were reported as median (credible interval). Maximum change from Baseline till 6h was reported.|Day 1 (Baseline [pre-NAC] to post-NAC 6 h)|Safety population||Percent change||95% Confidence Interval|Median
638215|NCT02446613|Primary|Percent Change From Baseline in the PNIF up to Post-NAC 6 h|PNIF data recorded at Baseline pre-challenge and at 15, 30 min, 1, 2, 3, 4, 5, 6h. The percent change from Baseline and at specified time point was derived by the formula (PNIF at Baseline minus PNIF at Post-NAC specified time point) divided by PNIF at Baseline) multiplied by 100. The baseline values were the latest pre-dose assessments. Percent change in PNIF were reported as median (credible interval). WM 0-6h of 15, 30 min, 1, 2, 3, 4, 5, 6h was reported. WM were derived by first calculating the AUC using the trapezoidal rule, and then dividing by the time interval. If available, actual times were used in the calculation, otherwise planned relative times were used for the calculation.|Day 1 (Baseline [pre-NAC] to post-NAC 6 h)|Safety populaton||Percent change||95% Confidence Interval|Median
638216|NCT02446613|Primary|Percent Change From Baseline in the PNIF Over Post-NAC 1 h|PNIF data recorded at Baseline pre-challenge and at 15, 30 min and 1h. The percent change from Baseline and at specified time point was derived by the formula (PNIF at Baseline minus PNIF at Post-NAC specified time point) divided by PNIF at Baseline) multiplied by 100. The baseline values were the latest pre-dose assessments. Percent change in PNIF were reported as median (credible interval). WM 0-1 h of 15, 30 min and 1 h was reported. WM were derived by first calculating the AUC using the trapezoidal rule, and then dividing by the time interval. If available, actual times were used in the calculation, otherwise planned relative times were used for the calculation.|Day 1 (Baseline [pre-NAC] to post-NAC 1 h)|Safety population||Percent change||95% Confidence Interval|Median
638217|NCT02446613|Primary|Percent Change From Baseline in the Peak Nasal Inspiratory Flow (PNIF) at Post-NAC 15 Min|PNIF data recorded at Baseline pre-challenge and at 15, 30 min and 1h. The percent change from Baseline and at specified time point was derived by the formula (PNIF at Baseline minus PNIF at Post-NAC specified time point) divided by PNIF at Baseline) multiplied by 100. The baseline values were the latest pre-dose assessments. The baseline value were the latest pre-dose assessments. Percent change in PNIF were reported as median (credible interval). WM 0-1 h of 15, 30 min and 1 h was reported. WM were derived by first calculating the AUC using the trapezoidal rule, and then dividing by the time interval. If available, actual times were used in the calculation, otherwise planned relative times were used for the calculation.|Day 1 (Baseline [pre-NAC] and post-NAC 15 min)|Safety population||Percent change||95% Confidence Interval|Median
638276|NCT02444715|Primary|Change in HDL Level||baseline and 6 months|For participants who did not provide final questionnaires, data was retrieved from medical records. HDL data is missing for 5 of the 46 SC and 11 of the 48 IC participants who started the study.||mg/dl||Inter-Quartile Range|Median
638218|NCT02446613|Primary|Maximum (Max) Mean Change From Baseline (BL) in the TNSS Over Post-NAC 6 h|TNSS was obtained from 4 individual nasal sym.: nasal congestion, rhinorrhoea, nasal itch and sneezing. Par rated sym. on a 4-point scale. For nasal blockage and congestion the scores were (0= Breathing through nose freely and easily, 1= Slight difficulty breathing through nose, 2= Moderate difficulty breathing through nose and 3= Severe difficulty breathing through nose). For rhinorrhoea, nasal itching and sneezing (0= None: No sym. whatsoever; Absent, 1= Mild: Sym. is present, noticeable but not bothersome, 2= Moderate: Sym. is bothersome, but tolerable and 3= Severe: Sym. which are bothersome, harder to tolerate). The individual sym. scores were combined to produce a TNSS. TNSS were reported as median (credible interval). BL values were the latest pre-dose assessments. Change from BL was measured as the value recorded at a specified time point minus BL value. The max change from BL from the set of individual PNIF % reduction measurements made over the 0 to 6 h sampling period.|Day 1 (Baseline [pre-NAC] to post-NAC 6 h)|Safety population||Score on a scale||95% Confidence Interval|Median
638219|NCT02446613|Primary|Mean Change From Baseline in the TNSS Over Post-NAC 6 h|TNSS was obtained from 4 individual nasal sym. including nasal congestion, rhinorrhoea, nasal itch and sneezing. Participants rated sym. on a 4-point scale. For nasal blockage and congestion the scores were (0= Breathing through nose freely and easily, 1= Slight difficulty breathing through nose, 2= Moderate difficulty breathing through nose and 3= Severe difficulty breathing through nose). For rhinorrhoea, nasal itching and sneezing (0= None: No sym. whatsoever; Absent, 1= Mild: Sym. is present, noticeable but not bothersome, 2= Moderate: Sym. is bothersome, but tolerable and 3= Severe: Sym. which are bothersome, harder to tolerate). The individual sym scores were combined to produce a TNSS. TNSS were reported as median (credible interval). The baseline values were the latest pre-dose assessments. Change from baseline was measured as value recorded at a specified time point minus Baseline value. WM 0-6 h of 15, 30 min, 1, 2, 3, 4, 5, 6h was reported.|Day 1 (Baseline [pre-NAC] to post-NAC 6 h)|Safety population||Score on a scale||95% Confidence Interval|Median
638220|NCT02446613|Primary|Mean Change From Baseline in the TNSS Over Post-NAC 1 h|TNSS was obtained from 4 individual nasal sym. including nasal congestion, rhinorrhoea, nasal itch and sneezing. Participants rated sym. on a 4-point scale. For nasal blockage and congestion the scores were (0= Breathing through nose freely and easily, 1= Slight difficulty breathing through nose, 2= Moderate difficulty breathing through nose and 3= Severe difficulty breathing through nose). For rhinorrhoea, nasal itching and sneezing (0= None: No sym. whatsoever; Absent, 1= Mild: Sym. is present, noticeable but not bothersome, 2= Moderate: Sym. is bothersome, but tolerable and 3= Severe: Sym. which are bothersome, harder to tolerate). The individual sym scores were combined to produce a TNSS. TNSS were reported as median (credible interval). The baseline values were the latest pre-dose assessments. Change from baseline was measured as the value recorded at a specified time point minus Baseline value. Weighted mean (WM) 0-1h of 15, 30 min and 1 h was reported.|Day 1 (Baseline [pre-NAC], 15 to post-NAC 1h)|Safety population||Score on a scale||95% Confidence Interval|Median
638221|NCT02446613|Primary|Mean Change From Baseline in the Total Nasal Sym. Score (TNSS) at Post-NAC 15 Minutes (Min)|TNSS was obtained from 4 individual nasal sym. including nasal congestion, rhinorrhoea, nasal itch and sneezing. Participants rated sym. on a 4-point scale. For nasal blockage and congestion the scores were (0= Breathing through nose freely and easily, 1= Slight difficulty breathing through nose, 2= Moderate difficulty breathing through nose and 3= Severe difficulty breathing through nose). For rhinorrhoea, nasal itching and sneezing (0= None: No sym. whatsoever; Absent, 1= Mild: Sym. is present, noticeable but not bothersome, 2= Moderate: Sym. is bothersome, but tolerable and 3= Severe: Sym. which are bothersome, harder to tolerate). The individual sym. scores were combined to produce a TNSS. TNSS were reported as median (credible interval). The baseline values were the latest pre-dose assessments. Change from baseline was measured as the value recorded at 15 min post-NAC minus Baseline value.|Day 1 (Baseline [pre-NAC] and post-NAC 15 min)|The Safety population consisted of members of the ASP of parent study TL7116958 who had passed screening for study 204509.||Score on a scale||95% Confidence Interval|Median
638222|NCT02446496|Secondary|Apparent First-order Elimination or Terminal Rate Constant (Ke)|Plasma samples for PK analysis were drawn at indicated time points of each treatment period. Apparent first-order elimination or terminal rate constant calculated from a semi-log plot of the plasma concentration versus time curve. The parameter was calculated by linear least-squares regression analysis using the last three (or more) non-zero plasma concentrations.|Pre-dose (0.00) and 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00 and 12.00 hours post-dose in each treatment period.|All subject population. All participants were present at the time of measurement.||Per hour||Standard Deviation|Mean
638223|NCT02446496|Secondary|Time of the Maximum Plasma Concentration (T-max) and Terminal Half- Life (T-half)|Plasma samples for PK analysis were drawn at indicated time points of each treatment period. If the maximum value occurs at more than one point T-max was defined as the first time point with this value. The elimination or terminal half-life was calculated by dividing 0.693 (natural logarithm of 2) with lambda z, where lambda z is the terminal phase rate constant estimated by linear regression analysis of the log transformed concentration-time data after each single dose.|Pre-dose (0.00) and 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00 and 12.00 hours post-dose in each treatment period.|All subject population. All participants were present at the time of measurement.||Hour||Full Range|Median
638224|NCT02446496|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUC0-t) and Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-infinity)|Plasma samples for PK analysis were drawn at indicated time points of each treatment period. Area under the plasma concentration-time curve from time zero (0) to the last measurable concentration (t), as calculated by the linear trapezoidal method. Area under the plasma concentration-time curve from time zero (0) to infinity (AUC0-infinity) was calculated as the sum of the AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant (Ke), where first-order elimination or terminal rate constant calculated from a semi-log plot of the plasma concentration versus time curve. The parameter was calculated by linear least-squares regression analysis using the last three (or more) non-zero plasma concentrations.|Pre-dose (0.00) and 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00 and 12.00 hours post-dose in each treatment period.|All subject population. All participants were present at the time of measurement.||Microgram.hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
638277|NCT02444715|Primary|Change in Systolic Blood Pressure||baseline and 6 months|Blood pressure data is missing for 4 of the 36 SC and 4 of the 32 IC participants who provided final questionnaires.||mmHg||Standard Deviation|Mean
638225|NCT02446496|Primary|Maximal Measured Plasma Concentration (Cmax) After a Single Dose|Plasma samples for pharmacokinetic (PK) analysis were drawn at indicated time points of each treatment period. Cmax was defined as maximal measured plasma concentration over the time span specified.|Pre-dose (0.00) and 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00 and 12.00 hours post-dose in each treatment period.|All subject population: who were crossed over and completed the balance design, were included in the calculation. All participants were present at the time of measurement.||Microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
638226|NCT02446483|Secondary|Apparent First-order Elimination or Terminal Rate Constant|Plasma samples for PK analysis were drawn at indicated time points of each treatment period. Apparent first-order elimination or terminal rate constant calculated from a semi-log plot of the plasma concentration versus time curve. The parameter was calculated by linear least-squares regression analysis using the last three (or more) non-zero plasma concentrations.|Pre-dose (0.00) and 0.50, 1.00, 1.50, 2.00, 2.33, 2.66, 3.00, 3.33, 3.66, 4.00, 4.33, 4.66, 5.00, 5.33, 5.66, 6.00, 8.00, 12.00 and 14.00 h post-dose in each treatment period|All subject population. Data is presented for the participants available at the time of assessment.||Per hour||Geometric Coefficient of Variation|Geometric Mean
638227|NCT02446483|Secondary|Time of the Maximum Plasma Concentration (T-max) and Terminal Half-life (T-half)|Plasma samples for PK analysis were drawn at indicated time points of each treatment period. If the maximum value occurs at more than one point T-max was defined as the first time point with this value. The elimination or terminal half-life was calculated by dividing 0.693 (natural logarithm of 2) with b obtained as the slope of the linear regression of the logarithmically transformed plasma concentrations versus time in the terminal period of the plasma curve.|Pre-dose (0.00) and 0.50, 1.00, 1.50, 2.00, 2.33, 2.66, 3.00, 3.33, 3.66, 4.00, 4.33, 4.66, 5.00, 5.33, 5.66, 6.00, 8.00, 12.00 and 14.00 h post-dose in each treatment period.|All Subject Population. Only those participants available at the specified time points were analyzed.||h||Full Range|Median
638228|NCT02446483|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUC0-t) and Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-infinity)|Plasma samples for PK analysis were drawn at indicated time points of each treatment period. AUC0-t was calculated by the linear trapezoidal method. AUC0-infinity was calculated as the sum of the AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant, where first-order elimination or terminal rate constant was calculated from a semi-log plot of the plasma concentration versus time curve. The parameter was calculated by linear least-squares regression analysis using the last three (or more) non-zero plasma concentrations. Values were reported as Least Squares Geometric Means with respective % CV.|Pre-dose (0.00) and 0.50, 1.00, 1.50, 2.00, 2.33, 2.66, 3.00, 3.33, 3.66, 4.00, 4.33, 4.66, 5.00, 5.33, 5.66, 6.00, 8.00, 12.00 and 14.00 h post-dose in each treatment period.|All subject population. Only those participants available at the specified time points were analyzed.||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
638229|NCT02446483|Primary|Mean Maximal Measured Plasma Concentration (Cmax) After a Single Dose|Plasma samples for pharmacokinetic (PK) analysis were drawn at indicated time points of each treatment period. Cmax was defined as maximal measured plasma concentration over the time span specified. Values were reported as Least Squares Geometric Means with respective Geometric Coefficient of Variation (% CV).|Pre-dose (0.00) and 0.50, 1.00, 1.50, 2.00, 2.33, 2.66, 3.00, 3.33, 3.66, 4.00, 4.33, 4.66, 5.00, 5.33, 5.66, 6.00, 8.00, 12.00 and 14.00 h post-dose in each treatment period.|All subject population comprised of all participants who were crossed over and completed the balance design, were included in the calculation.||Nanogram per mL (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
638230|NCT02446171|Secondary|Taste Test Assessment.|A standardized questionnaire was provided to participants and were asked to complete the questionnaire for the liquid formulations tested, i.e., Naloxegol crushed tablet, oral (Treatment A) and Naloxegol oral solution (Treatment C), without assistance or influence from site personnel. For each formulation, the questionnaire was identical and required the participant's opinion. Sweet, salty, sour, bitter, metallic, hot/spicy were rated on a scale of 0 to 10, where 0 means not at all and 10 means extreme. The overall rating of the taste was rated on a scale of 0 to 10, where 0 means “I dislike it extremely much” and 10 means “I like it extremely much”. The smell of the medicine was based on a scale of 0 to 10, where 0 means extremely bad and 10 means extremely nice. The question on whether the participants would consider ever taking the medicine again was based on a scale of 0 to 10, where 0 means “Never – under no circumstances” and 10 means “Yes, definitely”.|Within 1 hour after dosing (Treatments A and C only).|The safety analysis set included all participants who had received at least one dose of Naloxegol and for whom any safety post-dose data were available.||units on a scale||Full Range|Median
638231|NCT02446171|Secondary|Participants With Significant Findings in Hematology, Clinical Chemistry and Urinalysis.|Participants were assessed through each laboratory variables for any significant abnormalities. Hematology assessments included white blood cell count, red blood cell count, hemoglobin, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin and others. Clinical chemistry assessment included testing levels of sodium, potassium, urea, creatinine, albumin, calcium, glucose (fasting) and others. Urinalysis assessment included glucose, protein, blood and microscopy (if positive for blood or protein).|At screening and at the final follow-up visit (maximum 9 weeks apart); in addition, for the first and third treatment period at pre-dose.|The safety analysis set included all participants who had received at least one dose of Naloxegol and for whom any safety post-dose data were available.||participants|||Number
638232|NCT02446171|Secondary|Participants With Significant Findings in 12-Lead Electrocardiography (ECG).|A 12-lead ECG was obtained after the participant rested in supine position for at least 10 minutes. The study physician was to judge the overall interpretation as normal or abnormal. If abnormal, it was decided as to whether or not the abnormality was clinically significant and the reason for the abnormality was recorded.|At screening, first admission to the clinical unit (Visit 2, Day -1), 1.25 hours after each dose (Visits 2-5, Day 1), as well as at the final follow-up visit (up to 9 weeks).|The safety analysis set included all participants who had received at least one dose of Naloxegol and for whom any safety post-dose data were available.||participants|||Number
638330|NCT02441218|Primary|Primary Composite Endpoint: First Event Among Cardiovascular Death (Including Death of Unknown Cause) or Hospitalization for Worsening Heart Failure.|Number of patients having experienced the Primary Composite Endpoint.|All over the study (up to 42 months).|||participants|||Number
638233|NCT02446171|Secondary|Participants With Significant Findings in Columbia-Suicide Severity Rating Scale (C-SSRS).|The C-SSRS is a unique, simple and short method of assessing both behavior and ideation that tracks all suicidal events, and provided a summary of suicidality. It assesses the lethality of attempts and other features of ideation (frequency, duration, controllability, reasons for ideation and deterrents), all of which are significantly predictive of completed suicide. The C-SSRS was performed to determine the presence of suicidality.|At Baseline and Days 1-4 of each treatment period.|The safety analysis set included all participants who had received at least one dose of Naloxegol and for whom any safety post-dose data were available.||participants|||Number
638234|NCT02446171|Secondary|Participants With Significant Findings in Physical Examination.|A complete physical examination included an assessment of the general appearance, respiratory, cardiovascular, abdomen, skin, head, and neck (including ears, eyes, nose, mouth and throat), lymph nodes, thyroid, musculoskeletal and neurological systems. Physical examination was performed to check for any significant abnormality in participants.|A full physical examination at screening and the final follow-up visit (maximum 9 weeks apart). Abbreviated physical examination on admission (on Day -1 of each treatment period) and at 48-hours post-dose to each treatment period (for up to 4 weeks).|The safety analysis set included all participants who had received at least one dose of Naloxegol and for whom any safety post-dose data were available.||participants|||Number
638235|NCT02446171|Secondary|Mean Change From Baseline for Vital Signs in Supine Pulse Rate.|Pulse rate: the measurement of vital signs for pulse rate is presented in the below outcome table.|Day 2 (24h post-dose), Day 3 (48h post-dose) and Day 4 (72h post-dose).|The safety analysis set included all participants who had received at least one dose of Naloxegol and for whom any safety post-dose data were available.||beats per minute (bpm)||Standard Deviation|Mean
638236|NCT02446171|Secondary|Mean Change From Baseline for Vital Signs of Supine Systolic and Diastolic Blood Pressure.|The following variables were collected after the participants had rested in the supine position for at least 5 minutes: Systolic Blood Pressure (SBP) and Diastolic BP. The measurement of vital signs for SBP and DBP are presented in the below outcome table.|Day 2 (24h post-dose), Day 3 (48h post-dose) and Day 4 (72h post-dose).|The safety analysis set included all participants who had received at least one dose of Naloxegol and for whom any safety post-dose data were available.||mmHg||Standard Deviation|Mean
638237|NCT02446171|Secondary|Percentage of Participants With Adverse Events (AE).|An AE is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.The term AE is used generally to include any AE whether serious or non-serious. An serious AE (SAE) is an AE that fulfills one or more of the following criteria: results in death, is immediately life-threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity or substantial disruption of the ability to conduct normal life functions; is a congenital abnormality or birth defect; is an important medical event that may jeopardize the participant or may require medical intervention to prevent one of the outcomes listed above.|For up to 9 weeks (starting with screening).|The safety analysis set included all participants who had received at least one dose of Naloxegol and for whom any safety post-dose data were available.||percentage of participants|||Number
638238|NCT02446171|Secondary|Apparent Volume of Distribution During the Terminal Phase After Extravascular Administration (Vz/F).|This was one of the PK parameters to determine the apparent volume of distribution during the terminal phase after extravascular administration.|Pre-dose (0 hours [within 30 minutes prior to IMP administration]) and post-dose at 0.25 (15 minutes), 0.5 (30 minutes), 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours in each treatment period.|The PK analysis set was a subset of those participants in the safety analysis set and included participants who had received at least 1 dose of study medication and had at least 1 post-dose plasma concentration measurement at a scheduled time point.||L||Geometric Coefficient of Variation|Geometric Mean
638239|NCT02446171|Secondary|Apparent Total Body Clearance After Extravascular Administration Estimated as Dose Divided by AUC (CL/F).|This was one of the PK parameters to determine the apparent total body clearance after extravascular administration estimated as dose divided by AUC. Blood was collected pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post-dose to determine naloxegol plasma concentrations.|Pre-dose (0 hours [within 30 minutes prior to IMP administration]) and post-dose at 0.25 (15 minutes), 0.5 (30 minutes), 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours in each treatment period.|The PK analysis set was a subset of those participants in the safety analysis set and included participants who had received at least 1 dose of study medication and had at least 1 post-dose plasma concentration measurement at a scheduled time point.||L/h||Geometric Coefficient of Variation|Geometric Mean
638240|NCT02446171|Secondary|Mean Residence Time (MRT).|This was one of the PK parameters to determine MRT. Blood was collected pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post-dose to determine naloxegol plasma concentrations.|Pre-dose (0 hours [within 30 minutes prior to IMP administration]) and post-dose at 0.25 (15 minutes), 0.5 (30 minutes), 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours in each treatment period.|The PK analysis set was a subset of those participants in the safety analysis set and included participants who had received at least 1 dose of study medication and had at least 1 post-dose plasma concentration measurement at a scheduled time point.||h||Standard Deviation|Mean
638241|NCT02446171|Secondary|Mean Dissolution Time (MDT).|This was one of the PK parameters to determine MDT (whole tablet only) (calculated as MRT Treatment D [Reference] - MRT Treatment C [Test]). Blood was collected pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post-dose to determine naloxegol plasma concentrations.|Pre-dose (0 hours [within 30 minutes prior to IMP administration]) and post-dose at 0.25 (15 minutes), 0.5 (30 minutes), 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours in each treatment period.|The PK analysis set was a subset of those participants in the safety analysis set and included participants who had received at least 1 dose of study medication and had at least 1 post-dose plasma concentration measurement at a scheduled time point. There were zero participants analyzed in Treatment A, B and C, hence data was not determined.||h||Standard Deviation|Mean
638333|NCT02441179|Secondary|"Percentage of Subjects With Worsening Pain Perception on the The Visual Analog Test"|The visual analog test assess general pain intensity. It is a 10-score scale ranging from no pain (score 0) to unbearable pain (score 10).|Pain perception at week 4|"Analysis per protocol"||percentage of subjects|||Number
638242|NCT02446171|Secondary|Half-life Associated With Terminal Slope (λz) of a Semi-logarithmic Concentration-time Curve (t½λz).|This was one of the PK parameters to determine λz of a t½λz. Blood was collected pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post-dose to determine naloxegol plasma concentrations.|Pre-dose (0 hours [within 30 minutes prior to IMP administration]) and post-dose at 0.25 (15 minutes), 0.5 (30 minutes), 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours in each treatment period.|The PK analysis set was a subset of those participants in the safety analysis set and included participants who had received at least 1 dose of study medication and had at least 1 post-dose plasma concentration measurement at a scheduled time point.||h||Standard Deviation|Mean
638243|NCT02446171|Secondary|Time to Reach Maximum Plasma Concentration (Tmax).|This was one of the PK parameters to determine the time to reach maximum plasma concentration (tmax). Blood was collected pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post-dose to determine naloxegol plasma concentrations.|Pre-dose (0 hours [within 30 minutes prior to IMP administration]) and post-dose at 0.25 (15 minutes), 0.5 (30 minutes), 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours in each treatment period.|The PK analysis set was a subset of those participants in the safety analysis set and included participants who had received at least 1 dose of study medication and had at least 1 post-dose plasma concentration measurement at a scheduled time point.||h||Full Range|Median
638244|NCT02446171|Primary|Observed Maximum Plasma Concentration (Cmax).|Observed maximum plasma concentration (Cmax) is presented below. Blood was collected pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post-dose to determine naloxegol plasma concentrations.|Pre-dose (0 hours [within 30 minutes prior to IMP administration]) and post-dose at 0.25 (15 minutes), 0.5 (30 minutes), 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours in each treatment period.|The PK analysis set was a subset of those participants in the safety analysis set and included participants who had received at least 1 dose of study medication and had at least 1 post-dose plasma concentration measurement at a scheduled time point.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
638245|NCT02446171|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC 0-t).|Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration is presented below. Blood was collected pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post-dose to determine naloxegol plasma concentrations.|Pre-dose (0 hours [within 30 minutes prior to IMP administration]) and post-dose at 0.25 (15 minutes), 0.5 (30 minutes), 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours in each treatment period.|The PK analysis set was a subset of those participants in the safety analysis set and included participants who had received at least 1 dose of study medication and had at least 1 post-dose plasma concentration measurement at a scheduled time point.||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
638246|NCT02446171|Primary|Area Under Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-infinity).|Area under plasma concentration-time curve from time zero extrapolated to infinity (AUC) is presented below. Blood was collected pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post-dose to determine naloxegol plasma concentrations.|Pre-dose (0 hours [within 30 minutes prior to administration of the investigational medicinal product (IMP)]) and post-dose at 0.25 (15 minutes), 0.5 (30 minutes), 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours in each treatment period.|The Pharmacokinetic (PK) analysis set was a subset of those participants in the safety analysis set and included participants who had received at least 1 dose of study medication and had at least 1 post-dose plasma concentration measurement at a scheduled time point.||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
638247|NCT02446015|Secondary|Change From Baseline in IDEEL Treatment Satisfaction Scores (Treatment Effectiveness and Treatment-related Inconvenience) at Day 28|The IDEEL is 10-question patient-reported outcome questionnaire that assesses the subject's general satisfaction with treatment use (Treatment Effectiveness and Treatment Inconvenience). A resultant overall 0-100 treatment satisfaction score was calculated separately for Treatment Effectiveness and Treatment Inconvenience, with higher scores indicating greater satisfaction and less treatment-related bother. One eye from each subject was chosen as the study eye and only the study eye was used for eye-level efficacy analyses.|Baseline (Day 0), Day 28|Intent-to-Treat Analysis Set. Number Analyzed is the number of subjects with non-missing response.||units on a scale||Standard Error|Least Squares Mean
638248|NCT02446015|Secondary|Change From Baseline in Impact of Dry Eye on Everyday Life Symptom-Bother (IDEEL SB) Score at Day 28|The IDEEL SB module is a 20 question patient reported outcome questionnaire that assesses the subject's symptoms of dry eye. An overall resultant calculated score ranges from 0 to 100, with higher scores indicating greater symptom bother. One eye from each subject was chosen as the study eye and only the study eye was used for eye-level efficacy analyses.|Baseline (Day 0), Day 28|Intent-to-Treat Analysis Set. Number Analyzed is the number of subjects with non-missing response.||units on a scale||Standard Error|Least Squares Mean
638249|NCT02446015|Primary|Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 28|"The TOSS score is a cumulative cornea and conjunctival staining score. After instilling ophthalmic dye in the eye, the investigator graded three areas of the ocular surface for dryness on a scale from 0 to 5, where 0 is Absent and 5 is Severe. The three scores were summed for a resultant overall 0-15 score. The change from baseline was calculated as the TOSS score at Day 28 minus the TOSS score at baseline. A more negative change value indicates greater efficacy. One eye from each subject was chosen as the study eye and only the study eye was used for eye-level efficacy analyses."|Baseline (Day 0), Day 28|Intent-to-Treat Analysis Set. Number Analyzed is the number of subjects with non-missing response.||units on a scale||Standard Error|Least Squares Mean
638250|NCT02445755|Primary|In This Study, the Investigators Plan to Test the Performance of a Novel Transcutaneous Device (BiliCareTM) to Screen for Bilirubin Levels at Postnatal Age of 12 to 48 Hours.||12 to 48 hours|||mg/dL||Standard Deviation|Mean
638251|NCT02445573|Other Pre-specified|Adverse Events|Number of participants who experienced Adverse Events was collected.|weeks 1-30|||participants|||Number
638252|NCT02445573|Secondary|Patient Self-evaluation of Therapeutic Effect|"Participants were asked to rate the extent of help that they received from treatment as no help, little help. moderate help or great help.
Number of participants reporting different extent of help was collected."|weeks 6, 18 and 30|||participants|||Number
673522|NCT01662102|Secondary|Complete Response Rate|Complete Response (CR) rates post randomization|Up to 24 months||||||
638253|NCT02445573|Secondary|Change From Baseline of the Total ICIQ-SF Scores|The International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) was a brief and robust measure for evaluating the symptoms and impact of urinary incontinence.It was used to assess the influence of urinary incontinence on quality of life during the past 4 weeks retrospectively. It contained three items on frequency, amount of leakage, and overall impact on quality of life, and a fourth, non-scored item for the assessment of type of incontinence. A total score was summed by the scores of the first three items, ranging from 0 to 21. A higher value indicates increased severity.|Baseline, and weeks 6, 18 and 30|||units on a scale||Standard Error|Mean
638254|NCT02445573|Secondary|Change From Baseline of the 72-hour Incontinence Episode Frequency (IEF)|"Data of IEF was from 72-hour bladder diary recorded by participants over the last 72 hours of weeks 0 (baseline), weeks 2, 4, 6 (treatment period) and weeks 15-18,and 27-30 (follow-up period).
The 72-hour IEF of weeks 1-6 equaled the sum of 72h IEF at weeks 2, 4 and 6 divided by 3; The 72-hour IEF of weeks 15-18 equaled the sum of 72h IEF at weeks 15-18 divided by 4; The 72-hour IEF of weeks 27-30 equaled the sum of 72h IEF at weeks 27-30 divided by 4."|Baseline, weeks 1-6, weeks 15-18 and weeks 27-30|||episodes||Inter-Quartile Range|Median
638255|NCT02445573|Primary|Change From Baseline of Urine Leakage Measured by 1-hour Pad Test||Baseline and week 6|||g||Inter-Quartile Range|Median
638256|NCT02445287|Primary|Radlex Scale for Diagnostic Quality Ratings - 3D Images SND|1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.|12 weeks after last image capture|140 image ratings from 4 radiologist readers (35 specimens rated x 4 readers) for the for Reference-Cadavers 3D arm above. 204 image ratings from 4 radiologist readers (35 specimens, + 13 human subjects, + 3 specimens w/o metal correction rated x 4 readers) for the Investigational-Cadavers & Human Subjects 3D-SND arm above.||units on a scale|images|Standard Error|Mean
638257|NCT02445287|Primary|Radlex Scale for Diagnostic Quality Ratings - 3D Images FDK|1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.|12 weeks after last image capture|140 image ratings from 4 radiologist readers (35 specimens rated x 4 readers) for the for Reference-Cadavers 3D arm above. 204 image ratings from 4 radiologist readers (35 specimens, + 13 human subjects, + 3 specimens w/o metal correction rated x 4 readers) for the Investigational-Cadavers & Human Subjects 3D-FDK arm above.||units on a scale|images|Standard Error|Mean
638258|NCT02445287|Primary|Radlex Scale for Diagnostic Quality Ratings - 3D Images High Resolution|1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.|12 weeks after last image capture|140 image ratings from 4 radiologist readers (35 specimens rated x 4 readers) for the for Reference-Cadavers 3D arm above. 204 image ratings from 4 radiologist readers (35 specimens, + 13 human subjects, + 3 specimens w/o metal correction rated x 4 readers) for the Investigational-Cadavers & Human Subjects 3D-High Resolution arm above.||units on a scale|images|Standard Error|Mean
638259|NCT02445287|Primary|Radlex Scale for Diagnostic Quality Ratings - 2D Images|1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.|12 weeks after last image capture|140 total image ratings from 4 radiologist readers (35 specimens rated x 4 readers) for each of the above two arms.||units on a scale|images|Standard Error|Mean
638260|NCT02445196|Secondary|Sustained Change in PTSD Symptoms Measured by the Post Traumatic Stress Disorder Checklist (PCL)|PTSD symptoms were assessed with the PCL-C (Weathers et al., 1993), a 17-item self-report measure of DSM-IV PTSD symptoms with strong psychometric properties (Wilkins, Lang, & Norman, 2011). Items are rated on how much the symptom bothered the respondent in the past month on a scale ranging from 1 (not at all) to 5 (extremely), with the sum score ranging from 17 to 85 providing a symptom severity rating, with higher ratings indicating more severe PTSD symptoms.|Postreatment to 3-month Follow-up|||units on a scale||Standard Deviation|Mean
638261|NCT02445196|Secondary|Change in Depression Symptoms Measured by the Patient Health Questionnaire (PHQ8)|Depression was assessed with the Patient Health Questionnaire depression scale (PHQ-8; Kroenke et al., 2009), an 8-item self-report measure of depression with evidence showing its ability to measure depression symptom severity and potential diagnosis. Items are rated on how much the symptom bothered the respondent in the past two weeks on a scale ranging from 0 (not at all) to 3 (nearly every day). Total scores can range from 0 to 24, with higher scores indicating more severe depression symptoms. Cronbach’s alpha at baseline was .87.|Baseline to Posttreatment (3 months)|||units on a scale||Standard Deviation|Mean
638262|NCT02445196|Secondary|Change in Interpersonal Functioning Measured by a Brief Inventory of Psychosocial Functioning (IPF7)|Psychosocial functioning was measured using the Brief Inventory of Psychosocial Functioning (B-IPF; Erb, Kearns, Bovin et al., 2015), a 7-item self-report measure. Items are rated on how much trouble the respondent had in the past month in relationships or other important areas of functioning (e.g., work, training or education) on a scale ranging from 0 (not at all) to 6 (very much). An average of applicable items provides an index of psychosocial functioning, with higher scores reflecting more poorer psychosocial functioning. Cronbach’s alpha at baseline was .82.|Baseline to Posttreatment (3 months)|||units on a scale||Standard Deviation|Mean
638263|NCT02445196|Secondary|Change in Subject Coping Self-efficacy Measured by a Questionnaire Assessing Confidence in Managing Core Symptoms of PTSD Addressed in the Intervention|PTSD symptom coping SE was assessed with a 9-item self-report measure developed for the study following Bandura’s guidelines (Bandura, 2006). Items assess confidence in managing PTSD symptoms and reaching out for support on a scale from 0 (cannot do at all) to 100 (highly certain can do). The average score provides an overall measure of SE with higher scores reflecting greater self-efficacy coping with PTSD symptoms. Cronbach’s alpha at baseline was .87.|Baseline to Posttreatment (3 months)|||units on a scale||Standard Deviation|Mean
638264|NCT02445196|Primary|Change in PTSD Symptoms Measured by the Post Traumatic Stress Disorder Checklist (PCL)|PTSD symptoms were assessed with the PCL-C (Weathers et al., 1993), a 17-item self-report measure of DSM-IV PTSD symptoms with strong psychometric properties (Wilkins, Lang, & Norman, 2011). Items are rated on how much the symptom bothered the respondent in the past month on a scale ranging from 1 (not at all) to 5 (extremely), with the sum score ranging from 17 to 85 providing a symptom severity rating, with higher ratings indicating more severe PTSD symptoms.|Baseline to Posttreatment (3 months)|||units on a scale||Standard Deviation|Mean
638265|NCT02444715|Other Pre-specified|Usability: SUS Score|"The usability of the intervention was assessed based on the standardised System Usability Scale (SUS).
SUS scores were not collected in the SC group because the SC participants were not using CAPSYS and hence were not able to assess its usability.
The System Usability Scale (SUS) provides a “quick and dirty”, reliable tool for measuring the usability. It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree. Originally created by John Brooke in 1986, it allows to evaluate a wide variety of products and services, including hardware, software, mobile devices, websites and applications.
The total SUS score computed based on the responses provided to each of the 10 items can range from 0 (worst) to 100 (best). Based on research, a SUS score above a 68 would be considered above average and anything below 68 is below average."|6 months|SUS questionnaires are missing, incomplete or invalid for 6 of the 32 IC participants who provided final questionnaires.||units on a scale (total SUS score)||Standard Deviation|Mean
638266|NCT02444715|Secondary|Change in Quality of Life|"The QoL was measured using the standardised EQ-5D-5L instrument provided by the EuroQol Group.
In this context, the health value was specified by the participants on a subjective scale ranging from 0 (The worst health you can imagine) to 100 (The best health you can imagine)."|baseline and 6 months|Data on quality of life was retrieved from final questionnaires. Hence, QoL data is missing for the 10 SC and 16 IC participants who did not provide final questionnaires.||units on a scale (health value)||Inter-Quartile Range|Median
638267|NCT02444715|Secondary|Change in Duration of Physical Activity|Self-reported weekly duration of physical activity of medium or high intensity|baseline and 6 months|Data on physical activity was retrieved from final questionnaires. Hence, physical activity data is missing for the 10 SC and 16 IC participants who did not provide final questionnaires.||minutes||Inter-Quartile Range|Median
638268|NCT02444715|Secondary|Change in Sweets Consumption|"Self-reported weekly portions of sweets consumption
(During the recruiting interview, participants were instructed in estimating the size of a portion of sweets and they were provided an information booklet on this topic.)"|baseline and 6 months|Data on sweets consumption was retrieved from final questionnaires. Hence, food consumption data is missing for the 10 SC and 16 IC participants who did not provide final questionnaires.||portions||Inter-Quartile Range|Median
638269|NCT02444715|Secondary|Change in Whole Grain Food Consumption|"Self-reported weekly portions of whole grain food consumption
(During the recruiting interview, participants were instructed in estimating the size of a portion of whole grain food and they were provided an information booklet on this topic.)"|baseline and 6 months|Data on whole grain food consumption was retrieved from final questionnaires. Hence, food consumption data is missing for the 10 SC and 16 IC participants who did not provide final questionnaires.||portions||Inter-Quartile Range|Median
638270|NCT02444715|Secondary|Change in Fruits and Vegetables Consumption|"Self-reported weekly portions of fruits and vegetables consumption
(During the recruiting interview, participants were instructed in estimating the size of a portion of fruits or vegetables and they were provided an information booklet on this topic.)"|baseline and 6 months|Data on fruits and vegetables consumption was retrieved from final questionnaires. Hence, food consumption data is missing for the 10 SC and 16 IC participants who did not provide final questionnaires.||portions||Inter-Quartile Range|Median
638271|NCT02444715|Primary|Change in BMI Value||baseline and 6 months|For participants who did not provide final questionnaires, data was retrieved from medical records. Weight data is missing for 9 of the 46 SC and 15 of the 48 IC participants who started the study.||kg/m^2||Standard Deviation|Mean
638272|NCT02444715|Primary|Change in Glycaemia Level||baseline and 6 months|For participants who did not provide final questionnaires, data was retrieved from medical records. Glycaemia data is missing for 6 of the 46 SC and 13 of the 48 IC participants who started the study.||mg/dl||Inter-Quartile Range|Median
638273|NCT02444715|Primary|Change in HbA1c Level||baseline and 6 months|For participants who did not provide final questionnaires, data was retrieved from medical records. HbA1c data is missing for 21 of the 46 SC and 21 of the 48 IC participants who started the study.||percent HbA1c||Inter-Quartile Range|Median
638274|NCT02444715|Primary|Change in Triglyceride Level||baseline and 6 months|For participants who did not provide final questionnaires, data was retrieved from medical records. Triglyceride data is missing for 16 of the 46 SC and 16 of the 48 IC participants who started the study.||mg/dl||Inter-Quartile Range|Median
638275|NCT02444715|Primary|Change in LDL Level||baseline and 6 months|For participants who did not provide final questionnaires, data was retrieved from medical records. LDL data is missing for 5 of the 46 SC and 11 of the 48 IC participants who started the study.||mg/dl||Inter-Quartile Range|Median
638278|NCT02444533|Secondary|Number of Subjects With Post-tonsillectomy Bleeding|The rate of post-tonsillectomy bleeding will be recorded and compared to the arm who did not receive the injection.|4 weeks|In the Liposomal Bupivacaine arm, 15 subjects had data on the primary endpoints, and an additional 2 provided information regarding post-procedure complications, but didn't provide data on other outcomes, therefore the analysis population for the Liposomal Bupivacaine is 17.||Participants|||Count of Participants
638279|NCT02444533|Secondary|Number of Subjects Experiencing Complications ( Allergic Reaction, Swallowing Dysfunction, Hospital Admission Related to the Study Drug)|Patients will be monitored for drug related complications such as allergic reaction, swallowing dysfunction, hospital admission related to the study drug.|4 weeks|||Participants|||Count of Participants
638280|NCT02444533|Primary|Oral Intake (Patient Recorded Oral Intake)|Subjects recorded oral intake over one week after surgery|1 week after surgery|||mL||Standard Deviation|Mean
638281|NCT02444533|Primary|Pain Medication Usage (Milligrams Used)|Subjects recorded pain medication usage in milligrams used of Tylenol, Ibuprofen, and Oxycodone over a 2 week time frame|2 weeks after surgery|One subject on the no treatment arm was excluded for lack of follow up data, therefore 18 (from participant flow) -1 = 17.||mg||Standard Deviation|Mean
638282|NCT02444533|Primary|Pain Score (Pain Scores on a 0/10 Scale)|"Subjects recorded pain scores four times a day in a daily pain diary using a Visual Analog Scale with markings from 0 to 10. 0 indicated no pain and 10 indicated worst possible pain"|day of surgery, 14 days after surgery|Results include only subjects who were reported as having at least partial outcome data.||units on a scale||Standard Deviation|Mean
638283|NCT02444182|Primary|Plaque Index|"A modified Quickley-Hein plaque index (PI) was used to record the buccal and lingual surfaces of all teeth (from right second molar to left second molar) 0 = no plaque
= separate flecks of plaque at the cervical margin of the tooth
= a thin continuous band of plaque at the cervical margin
= a band of plaque wider than 1 mm but covering less than 1/3 of the crown
= plaque covering at least 1/3 but less than 2/3 of the crown
= plaque covering 2/3 or more of crown
An index for the entire mouth is determined by dividing the total score by the number surfaces (a maximum of 2 x 2 x 14 = 56 surfaces) examined.
** Plaque index score reported in the table below represents Pl for the entire mouth. the range is between 0 (no plaque) to 5 (maximum plaque coverage)"|four weeks|||units on a scale||Standard Deviation|Mean
638284|NCT02444182|Primary|Gingival Health|"The gingival Index of Loe and Silness (1963) was used to record all surfaces (buccal, lingual, mesial, distal) for index teeth (16, 12, 24, 36, 32, 44). Gingival pockets were gently touched with a periodontal probe and possible bleeding was registered.
The criteria are:
0 = no inflammation
= mild inflammation, slight change in color, slight edema, no bleeding on probing
= moderate inflammation, moderate glazing, redness, bleeding on probing
= severe inflammation, marked redness and hypertrophy, ulceration, tendency to spontaneous bleeding
The GI of the tooth was determined by adding the scores of the four surfaces and divided the total by four.
The GI of the individual was obtained by adding the values of each tooth and dividing by the number of teeth examined
A score from 0.1-1.0 = mild inflammation; 1.1-2.0 = moderate inflammation, and 2.1-3.0 = severe inflammation"|Four weeks|||units on a scale||Standard Deviation|Mean
638285|NCT02443792|Secondary|Infection|Proportion experiencing post-op infection, determined clinically (treated with antibiotics)|Up to 4 weeks|||participants|||Number
638286|NCT02443792|Secondary|Wound Dehiscence|Proportion experiencing wound dehiscence (< 2 cm vs > 2 cm)|Up to 4 weeks|||participants|||Number
638287|NCT02443792|Secondary|Completely Healed at 4 Weeks|Number of participants who were completely healed at 4 weeks|At the 4-week followup visit|||participants|||Number
638288|NCT02443792|Secondary|Surgical Pain 0=no Pain; 10=Worst Pain Ever|Self-described pain severity during procedure (scale 1 to 10). 0=no pain, 5=moderate pain, 10=worst pain ever|Up to 30 minutes|||units on a scale||Standard Deviation|Mean
638289|NCT02443792|Primary|Time Elapsed From First Clamp (Surgical) or Start of Insertion of Bell (Unicirc) to Beginning of Wound Dressing|Time elapsed from first clamp (surgical) or start of insertion of bell (Unicirc) to beginning of wound dressing|Up to 30 minutes|||Minutes||Inter-Quartile Range|Median
638290|NCT02442804|Secondary|Change From Baseline State-Trait Anxiety Inventory - Trait Score|The State-Trait Anxiety Inventory (STAI) is a self-report inventory of anxiety symptoms. The test consists of two parts: 20 questions that assess anxiety level at the time of the examination (i.e., state) and 20 questions that assess the examinee’s general level of anxiety (i.e., trait). Items include feeling at ease, feeling upset, feeling self-confident, feeling confused, feeling like a failure, feeling rested, and having disturbing thoughts, among others. Examinees endorse 1 of 4 options on a likert scale, from “not at all” to “very much so.” Each of the scales (state and trait) ranges from 0 to 80. Higher score indicates more anxiety symptoms.|Baseline and Day 9|||raw score||Standard Deviation|Mean
638291|NCT02442804|Secondary|Change From Baseline State-Trait Anxiety Inventory - State Score|The State-Trait Anxiety Inventory (STAI) is a self-report inventory of anxiety symptoms. The test consists of two parts: 20 questions that assess anxiety level at the time of the examination (i.e., state) and 20 questions that assess the examinee’s general level of anxiety (i.e., trait). Items include feeling at ease, feeling upset, feeling self-confident, feeling confused, feeling like a failure, feeling rested, and having disturbing thoughts, among others. Examinees endorse 1 of 4 options on a likert scale, from “not at all” to “very much so.” Each of the scales (state and trait) ranges from 0 to 80. Higher score indicates more anxiety symptoms.|Baseline and Day 9|||raw score||Standard Deviation|Mean
638292|NCT02442804|Secondary|Change From Baseline Beck Depression Inventory - II (BDI-II) Score|The Beck Depression Inventory – Second Edition (BDI-II) is a widely used self-report questionnaire of depressive symptoms. The examinee is asked to respond to 21 items by endorsing whether or not they experience symptoms of sadness, pessimism, past failure, loss of pleasure, guilty feelings, punishment feelings, self-dislike, self-criticalness, suicidal thoughts or wishes, crying, agitation, loss of interest, indecisiveness, worthlessness, loss of energy, changes in sleeping pattern, irritability, changes in appetite, concentrating difficulty, tiredness or fatigue, and loss of interest in sex. Examinees can also describe the degree of severity of each symptom, as each item ranges from 0-3. The scorer adds the scores for each item to attain a total score, which is interpreted according to the following guidelines: 0-13 = minimal depression, 14-19 = mild depression, 20-28 = moderate depression, 29-63 = severe depression|Baseline and Day 9|||raw score||Standard Deviation|Mean
647809|NCT02117193|Primary|Aerobic Performance|Aerobic performance will be determined through the subject's heart rate|After each sequence, up to 8 hours|||bpm||Standard Deviation|Mean
638293|NCT02442804|Secondary|Change From Baseline Animals Fluency Score|The Animal Fluency task involves providing the examinee a category prompt. For example, the examiner asks the examinee to name as many animals as he or she can in 1 minute. The total number of acceptable words is tallied for a total score (ranging from 0 on up). Higher scores indicate better performance.|Baseline and Day 9|||number of acceptable words (animals)||Standard Deviation|Mean
638294|NCT02442804|Secondary|Change From Baseline Trail-making Test Part B Score|The Trail-making Test Part B consists of circles with either numbers (1 - 13) or letters (A - L) in them; as in Part A, the patient draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters (i.e., 1-A-2-B-3-C, etc.). Results for both TMT A and B are reported as the number of seconds required to complete the task (ranges from 0 to 300; discontinued at 300 seconds); therefore, higher scores reveal greater impairment.|Baseline and Day 9|||seconds||Standard Deviation|Mean
638295|NCT02442804|Secondary|Change From Baseline Line Bisection Test Score|The Line Bisection Test consists of 20 horizontal lines of varying length and proximity to the center of a sheet of paper (i.e., some are closer to the left or right sides of the page). The examinee is asked to place a mark to bisect each line. The scorer measures the degree of deviation from the center of each line (in cm) and attains the absolute value of the average percentage of deviation across all 20 lines. The scorer also attains the dominant direction of deviation (i.e., whether the examinee misses more to the left or to the right on average across the 20 lines). The value of the largest deviation is imputed for any omissions. Percentage ranges from 0 on up. Higher percentage of deviation indicates worse performance.|Baseline and Day 9|||percentage of deviation from center||Standard Deviation|Mean
638296|NCT02442804|Secondary|Change From Baseline Controlled Oral Word Association Test Score|The Controlled Oral Word Association Test (COWAT) is a measure of controlled verbal fluency that involves the examinee naming as many words that begin with a certain letter of the alphabet as he or she can in 1 minute. There are a few rules (i.e., no proper nouns and no words that have the same meaning and only differ by its suffix) and the task is repeated twice more with different letters each time. The scorer tallies the total acceptable words from all 3 trials into one total score (ranges from 0 on up). Higher total score indicates better performance.|Baseline and Day 9|||number of acceptable words||Standard Deviation|Mean
638297|NCT02442804|Secondary|Change From Baseline Brief Test of Attention Score|On the Brief Test of Attention (BTA), the examinee listens to a string of numbers and letters and must mentally tally (without the use of their fingers) how many numbers are in a particular trial. They do this for 10 trials and then are given 10 additional trials with the task of tallying how many letters they hear. The task increases in difficulty as the trials progress, and the entire test takes 5-10 minutes to complete. The scorer adds the number of trials correct from all 20 trials to attain a total score (ranges from 0 to 20). Higher scores indicate better performance.|Baseline and Day 9|||raw score||Standard Deviation|Mean
638298|NCT02442804|Secondary|Change From Baseline Trail-making Test Part A Score|The Trail-making Test consists of 25 circles distributed over a sheet of paper. In Part A, the circles are numbered 1 - 25, and the patient should draw lines to connect the numbers in ascending order. Results for the test are reported as the number of seconds required to complete the task (ranges from 0 to 300; discontinued at 300 seconds); therefore, higher scores reveal greater impairment.|Baseline and Day 9|||seconds||Standard Deviation|Mean
638299|NCT02442804|Secondary|Change From Baseline Functional Independence Measure (FIM) Score|Functional Independence Measure (FIM) Score consists of eighteen sub-measures under the following 6 categories: Self-Care (eating, grooming, bathing, dressing upper body, dressing lower body, toileting), Sphincter Control (bladder control, bowel control), Transfers (bed/chair/wheelchair transfer, toilet transfer, tub/shower transfer), Locomotion (walk/wheelchair, stairs), Communication (comprehension, expression), and Social Cognition (social interaction, memory, problem solving). Scores for each sub-measure range from 1 (total assistance) to 7 (complete independence), and the 18 scores are summed to obtain the FIM score. Higher scores indicate better performance.|Baseline and Day 9|||raw score||Standard Deviation|Mean
638300|NCT02442804|Secondary|Change From Baseline Mini-Mental State Examination - 2nd Edition Score|The MMSE-2 is a brief (about 10 minutes) screening tool that touches upon orientation to time and place, recall, attention/calculation, naming, repetition, comprehension, reading, writing, and drawing, with all the scores from these domains cumulating to a maximum of 30 points (minimum = 0). Higher score indicates better performance.|Baseline and Day 9|||raw score||Standard Deviation|Mean
638301|NCT02442804|Primary|Change From Baseline Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Score|The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) provides both a total scale score and scores for 5 different cognitive domains. It is relatively brief (approximately 20 minutes total) and has alternate forms. Specifically, the test measures immediate memory (with list learning and story memory), visuospatial/constructional ability (with figure copy and line orientation), language (with picture naming and semantic fluency), attention (with digit span and coding), and delayed memory (with list recall, list recognition, story recall, and figure recall). Scores from all subtests are aggregated into a total composite score (manual provides conversion procedure). RBANS data were age-normed based on the sample described in the manual (Randolph, 2012) and were analyzed as index scores (also referred to as standard scores), which have a mean of 100 and a standard deviation of 15. Higher scores on each sub measure and index indicate better performance.|Baseline and Day 9|||standard score change||Standard Deviation|Mean
638302|NCT02442700|Secondary|Safety of Pitavastatin in HIV-infected Patients|"Safety clinical was defined by FDA; grade 1 mild symptoms; grade 2 moderate symptoms with limiting age-appropriate IADL; grade 3 severe symptoms with limiting self-care ADL, But not immediately life-threatening; grade 4 life-threatening consequences; and grade 5 death related to adverse event.
Safety laboratory evaluation was determined safe if AST, ALT, and/or CPK level was not increased significantly comparing pitavastatin to placebo."|12 weeks|||U/L||95% Confidence Interval|Mean
638303|NCT02442700|Primary|Efficacy of Pitavastatin in HIV-infected Patients With Dyslipidemia and Receiving Atazanavir/Ritonavir|Efficacy was measured by level of TC, TG, LDL, and HDL that decreased after pitavastatin treatment. Pitavastatin was considered efficient when it could decrease TC, TG, LDL, or HDL significantly compared to placebo.|12 weeks|||mg/dL||95% Confidence Interval|Mean
638334|NCT02441179|Secondary|Percentage of Subjects With Worsening Muscle Tone on the Ashworth Scale|The Ashworth Scale assess muscle tone. It is a 5-points scale ranging from 0 (no increase in muscle tone) to 4 (limb rigid in flexion or extension).|Muscle tone at week 4.|"Analysis per protocol"||percentage of subjects|||Number
638304|NCT02442349|Secondary|Disease Control Rate (DCR) According to RECIST 1.1|Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions; Stable disease (SD): Neither sufficient shrinkage to qualify as a response nor sufficient growth to qualify as progression; Progressive Disease (PD): >= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of >=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. DCR is the percentage of patients with best response of CR, PR or SD (according to independent review), prior to progression (PD) or further anti-cancer therapy.|RECIST tumour assessments every 6 weeks from time first dose until date of progression, for an average of approximately 12 months. Results are based on the data cut off of 04 March 2016 (about 18 weeks after LSFD).|All patients who received at least 1 dose of study treatment and had measurable disease at baseline by blinded independent central review (BICR) of baseline imaging data.||% of participants||95% Confidence Interval|Number
638305|NCT02442349|Primary|Objective Response Rate (ORR) According to RECIST 1.1|Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. ORR is the percentage of patients with at least 1 visit response of CR or PR (according to independent review) that was confirmed at least 4 weeks later, prior to progression or further anti-cancer therapy.|RECIST tumour assessments every 6 weeks from time of first dose until objective disease progression, for an average of approximately 12 months. Results are based on the data cut off of 04 March 2016 (about 18 weeks after LSFD).|All patients who received at least 1 dose of study treatment and had measurable disease at baseline by blinded independent central review (BICR) of baseline imaging data.||% of participants||95% Confidence Interval|Number
638306|NCT02442310|Secondary|Number of Subjects With Adverse Events (AEs)|Number of subjects with AEs, by frequency, severity, time to onset, duration, and relatedness to study product. AEs will include clinically significant changes from baseline in vital signs, 12-lead ECG, physical examinations, and laboratory tests.|Throughout the trial, from the time of the first dose until the last study visit (Day 30 or early termination)|The safety population included all subjects who received at least one of the investigational products under study.||participants|||Number
638307|NCT02442310|Primary|AUC0-∞for Serum Deferiprone and Deferiprone 3-O-glucuronide|Area under the serum concentration time curve extrapolated to infinity. Blood samples will be collected pre-dose and over a 24-hour interval post-dose|24-hour interval|The pharmacokinetics population included all subjects who provided evaluable data for at least one of the comparisons of interest||ug*h/mL||Standard Deviation|Mean
638308|NCT02442310|Primary|Tmax for Serum Deferiprone and Deferiprone 3-O-glucuronide|Time to maximum observed serum concentration. Blood samples will be collected pre-dose and over a 24-hour interval post-dose|24-hour interval|The pharmacokinetics population included all subjects who provided evaluable data for at least one of the comparisons of interest||Hour||Standard Deviation|Mean
638309|NCT02442310|Primary|Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide|Maximum measured serum concentration. Blood samples will be collected pre-dose and over a 24-hour interval post-dose|24-hour interval|The pharmacokinetics population included all subjects who provided evaluable data for at least one of the comparisons of interest||μg/mL||Standard Deviation|Mean
638331|NCT02441179|Secondary|Learning and Memory With the Complutense Verbal Learning Test (TAVEC)|"The TAVEC is the Spanish version of the California Verbal Learning Test and is used for the assessment of episodic verbal memory.
Z score ranges from -2 (worse outcome), -1, 0, 1 and 2 (best outcome). The normal population range is between -1 and 1.
Z score was calculated with the following formula: Z score = (direct score-average for a particular age range)/standard deviation"|Episodic verbal memory at week 4.|"Analysis per protocol"||Z scores||Inter-Quartile Range|Median
638332|NCT02441179|Secondary|Learning and Memory With the Rey-Osterrieth Complex Figure (ROCF) Test|"The ROCF is a neuropsychological instrument used for assessment of episodic visual memory.
Z score ranges from -2 (worse outcome), -1, 0, 1 and 2 (best outcome). The normal population range is between -1 and 1.
Z score was calculated with the following formula: Z score = (direct score-average for a particular age range)/standard deviation"|Episodic visual memory at week 4.|"Analysis per protocol"||Z scores||Inter-Quartile Range|Median
638314|NCT02442271|Secondary|(SF-36v2) Mental Component Summary (MCS) Scores: Change From Baseline to 12 Weeks After the Last Dose of Study Drug|The SF-36v2 is a non-disease specific Health Related Quality of Life (HRQoL) instrument. The SF-36v2 comprises 36 total items (questions) targeting a subject's functional health and well-being in 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health) with a recall period of four weeks. Domain scores are aggregated into a PCS score and a MCS score. Scores SF-36v2 scores range from 1-100: higher scores indicate a better state of health and a decrease from baseline represents worsening. If a participant answered at least 50% of the items in a multi-item scale of the SF-36v2, the missing items were imputed with the average score of the answered items in the same domain. In cases where the participant did not answer at least 50% of the items, the score for that domain was considered missing. The SF-36v2 MCS and PCS scores were not computed if any domain was missing.|Day 1 (Baseline), 12 weeks after the last actual dose of the study drug|All participants in the ITT population with evaluable data.||units on a scale||Standard Deviation|Mean
638315|NCT02442271|Secondary|Short-Form 36 Version 2 Health Survey (SF-36v2) Physical Component Summary (PCS) Scores: Change From Baseline to 12 Weeks After the Last Dose of Study Drug|The SF-36v2 is a non-disease specific Health Related Quality of Life (HRQoL) instrument. The SF-36v2 comprises 36 total items (questions) targeting a subject's functional health and well-being in 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health) with a recall period of four weeks. Domain scores are aggregated into a Physical Component Summary (PCS) score and a Mental Component Summary (MCS) score. SF-36v2 scores range from 1-100: higher scores indicate a better state of health and a decrease from baseline represents worsening. If a participant answered at least 50% of the items in a multi-item scale of the SF-36v2, the missing items were imputed with the average score of the answered items in the same domain. In cases where the participant did not answer at least 50% of the items, the score for that domain was considered missing. The SF-36v2 MCS and PCS scores were not computed if any domain|Day 1 (Baseline), 12 weeks after the last actual dose of the study drug|All participants in the ITT population with evaluable data.||units on a scale||Standard Deviation|Mean
638316|NCT02442271|Secondary|Hepatitis C Virus Patient-Reported Outcomes Instrument (HCV-PRO) Total Score: Change From Baseline to 12 Weeks After the Last Dose of Study Drug|The HCV-PRO has been developed to capture the function and well-being impact of HCV conditions and treatment and contains 16 items important to HCV-infected patients; items were totaled to a summary score. Scores range from 0 to 100. A higher HCV-PRO score indicates a better state of health and a decrease from baseline represents worsening. If a participant answered at least 12 of the 16 items, the missing items were imputed with the mean score of the answered items; if a participant did not answer at least 12 of the items, the total score was considered missing.|Day 1 (Baseline), 12 weeks after the last actual dose of the study drug|All participants in the ITT population with evaluable data.||units on a scale||Standard Deviation|Mean
638317|NCT02442271|Secondary|Percentage of Participants With SVR12 by Participant Eligibility for Treatment With Interferon (IFN) at Screening|SVR12 was defined as HCV RNA level <LLOQ 12 weeks after the last dose of study drug. Data are presented by prior HCV treatment experience. Data are provided by participants' eligibility for treatment with IFN at screening. Participants with missing data were counted as failures.|12 weeks after the last actual dose of study drug|All participants in the ITT population.||percentage of participants||95% Confidence Interval|Number
638318|NCT02442271|Secondary|Percentage of Participants With SVR12 by Participant Prior HCV Treatment Experience|SVR12 was defined as HCV RNA level <LLOQ 12 weeks after the last dose of study drug. Data are presented by prior HCV treatment experience. Data are provided by participants' prior HCV treatment experience at screening. Participants with missing data were counted as failures.|12 weeks after the last actual dose of study drug|All participants in the ITT population.||percentage of participants||95% Confidence Interval|Number
638319|NCT02442271|Secondary|Percentage of Participants With SVR12 by Fibrosis Stage|SVR12 was defined as plasma HCV RNA level <LLOQ]12 weeks after the last dose of study drug. The percentage of participants achieving SVR12 by fibrosis stage (F3 and F4) are presented. Participants with missing data were counted as failures.|12 weeks after the last actual dose of study drug|All participants in the ITT population.||percentage of participants||95% Confidence Interval|Number
638320|NCT02442271|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug. Participants with missing data were counted as failures.|12 weeks after the last actual dose of study drug|Intent-to-treat population: all participants who received at least 1 dose of study drug.||percentage of participants||95% Confidence Interval|Number
638321|NCT02441218|Secondary|Secondary Composite Endpoint|CV death, hospitalisation for worsening HF or hospitalisation for non-fatal myocardial infarction|From the date of randomisation to the date of the first event, up to 42 months|||participants|||Number
638322|NCT02441218|Secondary|Unplanned Hospitalisation for CV Reason||From the date of randomisation to the first documented hospitalisation, up to 42 months.|||participants|||Number
638323|NCT02441218|Secondary|Unplanned Hospitalisation for Any Cause||From the date of randomisation to the first documented hospitalisation, up to 42 months|||participants|||Number
638324|NCT02441218|Secondary|Hospitalisation for Cardiovascular Reason||From the date of randomisation to the first documented hospitalisation, up to 42 months|||participants|||Number
638325|NCT02441218|Secondary|Hospitalisation for Any Cause||From the date of randomisation to the date of first documented hospitalisation, up to 42 months|||participants|||Number
638326|NCT02441218|Secondary|Death From Heart Failure|Component of cardiovascular death|From the date of randomisation to death, up to 42 months.|||participants|||Number
638327|NCT02441218|Secondary|All-cause Mortality||From the date of randomisation to death, up to 42 months.|||participants|||Number
638328|NCT02441218|Secondary|Hospitalisation for Worsening Heart Failure||From the date of randomization to the date of first documented hospitalisation, up to 42 months|||participants|||Number
638329|NCT02441218|Secondary|Cardiovascular Death|Component of the primary composite endpoint|From the date of randomization until the date of death, up to 42 months|||participants|||Number
639969|NCT02368314|Primary|Frequency of Venous Thromboembolism Death||During the treatment period (14 days)|Patient who finished the study as per protocol and had contrast venography results for efficacy evaluation.||participants|||Number
638335|NCT02441179|Secondary|Gait Speed With the Timed up and go Test|The timed up and go test measures the time (in seconds) it takes the patient to stand-up from a seated position in a chair, walk 3 meters at a comfortable and safe pace, turn, walk back to the chair and sit down.|Change from baseline in gait speed five days after daily IH.|"The analysis was per protocol"||seconds||Standard Error|Mean
638336|NCT02441179|Secondary|Gait Endurance With the 6-Minute Walk Test|The 6-Minute Walk Test measures the distance (in meters) a patient is able to walk over 6 minutes.|Change from baseline in gait indurance five days after daily IH.|"The analysis was per protocol"||meters||Standard Error|Mean
638337|NCT02441179|Primary|Gait Speed With 10-Meter Walk Test|The 10-meter walk test measures the time (in seconds) that it takes a patient to walk 10m.|Change from baseline in gait speed five days after daily IH.|"Analysis was per protocol"||seconds||Standard Error|Mean
638338|NCT02441114|Secondary|Maximum Observed Concentration (Cmax)|Maximum observed concentration of fluticasone|Period 1 (day 1), 2 (day 15), and 3 (day 29) at 0 to 24 h post-dose|10 subjects for period 1 and 2; 6 subjects for period 3||pg/mL||Standard Deviation|Mean
638339|NCT02441114|Secondary|Time to Maximum Concentration (Tmax)|Time to maximum concentration of fluticasone|Period 1 (day 1), 2 (day 15), and 3 (day 29) at 0 to 24 h post-dose|10 subjects for period 1 and 2; 6 subjects for period 3||h||Full Range|Median
638340|NCT02441114|Primary|Area Under the Concentration Versus Time Curve (AUClast)|Area under the concentration of fluticasone versus time curve from the time of dosing to the last measurable concentration|Period 1 (day 1), 2 (day 15), and 3 (day 29) at 0 to 24 h post-dose|10 subjects for period 1 and 2; 6 subjects for period 3||h*pg/mL||Standard Deviation|Mean
638341|NCT02440659|Primary|Patient's Quality of Life|% of patients very much or extremely affected by dialysis|Baseline|||% of patients|||Number
638342|NCT02440633|Primary|AUC of OPS-2071 in Plasma|A single dose of 14C-OPS-2071was administered as an oral suspension under fasting conditions on the morning of Day 1. We measured OPS-2071 concentration in plasma and evaluated AUC 0-168h of OPS-2071 in plasma.|predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 h postdose.|||μg·h/L||Standard Deviation|Mean
638343|NCT02440633|Primary|Area Under Curve (AUC) of Total Radioactivity in Plasma and Whole Blood|A single dose of 14C-OPS-2071was administered as an oral suspension under fasting conditions on the morning of Day 1. We measured total radioactivity in plasma and whole blood each. We evaluated AUC 0-168h of total radioactivity in plasma and whole blood each. The AUCs in plasma and whole blood are of total radioactivity including the parent and metabolites.|predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 h postdose.|||μg eq.·h/L||Standard Deviation|Mean
638344|NCT02440633|Primary|The Amounts of Radioactivity Excreted in Urine and Faeces|A single dose of 14C-OPS-2071was administered as an oral suspension under fasting conditions on the morning of Day 1. We evaluated the cumulative excretion of total radioactivity (%) in feces and urine, up to 168 hours postdose.|up to144-168h postdose.|||percentage of administered dose||Standard Deviation|Mean
638345|NCT02440308|Secondary|68Ga-DOTA-Bombesin Feasibility|Feasibility of 68Ga-DOTA-Bombesin as a radiopharmaceutical for PET/MRI was assessed as the percentage of enrolled subjects who complete the examination, and for which the PET/MRI data were evaluable.|Up to 1 week|Includes all participants enrolled.||percentage of participants|||Number
638346|NCT02440308|Primary|Normal Biodistribution of 68Ga-DOTA-Bombesin|Radiopharmaceutical uptake in normal organs will be evaluated visually and measured semi-quantitatively using standardized uptake values (SUV) derived from the PET/CT scan software in patients with prostate cancer. Uptake values in different tissues will be measured as SUVmean (mean value for SUV). SUVmean values reflect relative uptake of the radiolabel into the tissue.|1 hour|All participants were averaged to provide SUVmean uptake in normal organs.||SUV-mean||Standard Deviation|Mean
638347|NCT02439879|Primary|Total Symptoms Score|Total symptoms score is a summation of presence, severity, and duration of the four main positive neuropathic sensory symptoms: lancinating/stabbing pain, burning pain, paresthesia, and asleep numbness|20 weeks|||units on a scale||Standard Error|Mean
638348|NCT02439164|Secondary|Brain Glioma Pathological Diagnose as a Measure of Tumor Type|the WHO grade and the type of glioma (WHO glioma grade I~II is regarded as low grade glioma, WHO glioma grade III~IV is regarded as high grade glioma)|2 weeks|"In non-neurosurgical group, patients were not diagnosed as glioma, so the belowed outcome measure data table could not indicate the number of glioma grade."||Participants|||Count of Participants
638349|NCT02439164|Secondary|Heart Rate as a Measure of Physiological Change|The HR was measured at three time points: baseline, sedation and sedation reversal.|1 hour|||bpm||Standard Deviation|Mean
638350|NCT02439164|Secondary|Mean Arterial Blood Pressure (MAP) as a Measure of Physiological Change|The MAP was measured at three time points: baseline, sedation and sedation reversal.|1 hour|||mmHg||Standard Deviation|Mean
638351|NCT02439164|Secondary|Number of Participants With OAA/S=4 After Sedation|OAA/S is Observer Assessment of Sedation with 5 levels (5 = alert, 4 = lethargic, 3 = aroused by voice, 2 = aroused by shaking, 1 = deep sleep), all participants have to achieve OAA/S=4 after sedation.|withing 1 hour|||Participants|||Count of Participants
638352|NCT02439164|Primary|Task Completing Time Change Between Sedation and Baseline Measured by 9-hole Peg Test|this is a focal neurologic deficits induced by sedatives, the outcome is the performing time changes after sedation as : sedation-baseline.|after sedation|||seconds||Standard Deviation|Mean
638353|NCT02439138|Secondary|Rate of Progressive Disease|Progressive disease measured by an 25% increase in serum IgM level with an absolute increase of at least 500mg/dL from the lowest attained IgM on therapy.|Participants were followed for the duration of therapy, a median of one cycle, for up to 3 cycles.|||percentage of participants with PD|||Number
638354|NCT02439138|Secondary|Rate of Stable Disease|Stable disease measured by serum IgM levels <25% reduced from baseline.|Participants were followed for the duration of therapy, a median of one cycle, for up to 3 cycles.|||percentage of participants with SD|||Number
638355|NCT02439138|Secondary|Rate of Minimal Response|Minimal response measured by decrease in serum IgM levels of between 25% and 50%.|Participants were followed for the duration of therapy, a median of one cycle, for up to 3 cycles.|||percentage of participants with MR|||Number
638356|NCT02439138|Secondary|Rate of Partial Response (PR)|PR measured by decrease in serum IgM levels of between 25% and 50% from baseline.|Participants were followed for the duration of therapy, a median of one cycle, for up to 3 cycles.|||percentage of participants with PR|||Number
655165|NCT01955044|Secondary|Resolvin Levels|Resolvin, a metabolite of LCPUFA, will be measured at 8 weeks of life.|8 weeks of life||02/2018||||
638358|NCT02439138|Secondary|Rate of Complete Response (CR)|CR measured by decrease in serum IgM levels to normal range, disappearnace of monoclonal protein by immunofixation, no evidence of bone marrow involvement, and resolution of any extramedullary disease by CT scan.|Participants were followed for the duration of therapy, a median of one cycle, for up to 3 cycles.|||percentage of participants with CR|||Number
638359|NCT02439138|Secondary|Percentage of Participants With Adverse Events|Assess the safety and tolerability of idelalisib|Participants were followed for the duration of therapy, a median of one cycle, for up to 3 cycles.|||percentage of participants with AEs|||Number
638360|NCT02439138|Primary|Overall Response Rate (ORR)|ORR measured by decrease in serum IgM level by at least 25% from baseline.|Participants were followed for the duration of therapy, a median of one cycle, for up to 3 cycles.|4 of 5 participants returned for at least 1 follow-up to assess disease response.||percentage of participants with response|||Number
638361|NCT02438540|Secondary|HOMA-IR|Changes of IR was calculated by the homeostasis model (HOMA-IR), proposed by Matthews et al. HOMA-IR = (fasting insulin (mmol/L) × fasting glucose (µIU/ml))/22•5. Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com), and clinical assessments and measurements undertaken after 3 weeks. Readings/assessment was performed at 3 weeks.|baseline, week 2, week 3|||units on a scale||Standard Deviation|Mean
638362|NCT02438540|Secondary|Body Mass Index (BMI)|change of BMI. Body height was measured to an accuracy of +/-0.1cm. BMI was calculated by dividing weight (kg) into height (squared m²).|baseline, week 3|||Kg/m²||Standard Deviation|Mean
638363|NCT02438540|Primary|Serotonin|changes in Serotonin blood level, Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com), and clinical assessments and measurements undertaken after 3 weeks. Readings/assessment was performed at 3 weeks.|baseline, week 2, week 3|||ng/ml||Standard Deviation|Mean
638364|NCT02438540|Primary|Resistin|Changes in Resistin blood level, Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com), and clinical assessments and measurements undertaken after 3 weeks. Readings/assessment was performed at 3 weeks.|baseline, week 2, week 3|||ng/ml||Standard Deviation|Mean
638365|NCT02438540|Primary|Glucagon-like Peptide-1 (GLP-1)|changes in GLP-1 blood level, Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com), and clinical assessments and measurements undertaken after 3 weeks. Readings/assessment was performed at 3 weeks.|baseline, week 2, week 3|||mmol/L||Standard Deviation|Mean
638366|NCT02438540|Primary|Adiponectin|Changes in Adiponectin blood level, Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com), and clinical assessments and measurements undertaken after 3 weeks. Readings/assessment was performed at 3 weeks.|baseline, week 2, week 3|||µg/ml||Standard Deviation|Mean
638367|NCT02438540|Primary|Leptin|changes in Leptin blood level, Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com), and clinical assessments and measurements undertaken after 3 weeks. Readings/assessment was performed at 3 weeks.|baseline, week 2, week 3|||ng/ml||Standard Deviation|Mean
638368|NCT02438540|Primary|Ceramides|Changes in ceramides blood level, Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com), and clinical assessments and measurements undertaken after 3 weeks. Readings/assessment was performed at 3 weeks.|baseline, week 2, week 3|||g/dl||Standard Deviation|Mean
638369|NCT02438540|Primary|High Density Lipoprotein Cholesterol (HDLc)|HDLc changes, Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com), and clinical assessments and measurements undertaken after 3 weeks. Readings/assessment was performed at 3 weeks.|baseline, week 2, week 3|||mmol/L||Standard Deviation|Mean
638370|NCT02438540|Primary|Low Density Lipoprotein Cholesterol (LDLc)||baseline, week 2, week 3|||mmol/L||Standard Deviation|Mean
638371|NCT02438540|Primary|Triglyceride (TG)||baseline, week 2, week 3|||mmol/L||Standard Deviation|Mean
638372|NCT02438540|Primary|Free Fatty Acids (FFAs)|Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com), and clinical assessments and measurements undertaken after 3 weeks. Readings/assessment was performed at 3 weeks.|baseline, week 2, week 3|||mmol/L||Standard Deviation|Mean
638388|NCT02437513|Other Pre-specified|Number of Participants With Reported Device Migration in the Larynx Post Implant|In patient change from baseline position of the device in the larynx of each patient assessed by endoscopy and/or other clinically appropriate methods (CT or video fluoroscopy) and recorded in migration direction and distance (cm)|1 weeks|||participants|||Number
638373|NCT02438540|Primary|C-reaction Protein (CRP)|CRP blood markers changes; Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com), and clinical assessments and measurements undertaken after 3 weeks. Readings/assessment was performed at 3 weeks.|baseline, week 2, week 3|||mg/dl||Standard Deviation|Mean
638374|NCT02438540|Primary|Tumor Necrosis Factor-α (TNF-α)|Blood markers changes in TNF α, were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com), and clinical assessments and measurements undertaken after 3 weeks. Readings/assessment was performed at 3 weeks.|baseline, week 2, week 3|||Pg/ml||Standard Deviation|Mean
638375|NCT02438540|Primary|Interleukin-6 (IL-6)|IL-6 changes, IL-6 were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com), and clinical assessments and measurements undertaken after 3 weeks. Readings/assessment was performed at 3 weeks.|baseline, week 2, week 3|||Pg/dl||Standard Deviation|Mean
638376|NCT02438540|Primary|Fasting Insulin (FINS)|change of FINS,Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com), and clinical assessments and measurements undertaken after 3 weeks. Readings/assessment was performed at 3 weeks.|baseline, week 2, week 3|||µIU/ml||Standard Deviation|Mean
638377|NCT02438540|Primary|Fasting Blood Sugar (FBS)|changes FBS, Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com), and clinical assessments and measurements undertaken after 3 weeks. Readings/assessment was performed at 3 weeks.|baseline, week 2, week 3|||mmol/L||Standard Deviation|Mean
638378|NCT02438540|Primary|Body Weight|The effect of Metformin and acupuncture combined therapy on weight loss (Change from baseline in body weight), body weight was measured while the subjects were dressed in light clothing after an overnight fasting and by a standard scale to an accuracy of +/-0.1 kg. All measures were recorded by one assessment, at baseline before the first time treatment, and before the last time treatment at week 3.|baseline, week 3|||kg||Standard Deviation|Mean
638379|NCT02438137|Secondary|Mean Change in Serum Cytokine Levels (Mean Difference of Log-transformed Values)|Levels of markers in the blood known as cytokines (measured in picograms per milliliter) were measured on a monthly basis from Month 0 (baseline) to Month 4. The outcome is the mean difference in cytokine level from baseline to month 4 (mean level at Month 4 - mean level at Baseline). Values were log-transformed for normality, prior to analysis.|Month 0 to Month 4|Cytokine analyses were conducted for those participants who completed the study and had interpretable Month 4 PSG results. Among this group, 3 participants did not have usable Month 4 blood specimens for this analysis. Thus, the mean difference in cytokine levels was calculated for 47 participants.||picograms/milliliter (log-transformed)||Standard Deviation|Mean
638380|NCT02438137|Primary|Mean Change in Apnea Severity as Measured by the Respiratory Disturbance Index (RDI)|For the 50 participants who had interpretable month 4 polysomnography (PSG) data available, mean change in sleep apnea severity, as measured by the mean change in respiratory disturbance index (RDI) between baseline (Month 0) PSG and Month 4 PSG, was calculated. The RDI represents the total number of apneas, hypopneas and respiratory-related arousals per hour of sleep.|Month 0 to Month 4|65 participants were randomized. 14 participants withdrew from the study or were lost to followup. 51 completed study activities. 50 (35 DMF and 15 placebo) both completed the study and had an interpretable Month 4 PSG. One participant's Month 4 PSG was uninterpretable, thus the RDI from this participant could not be included in the final analysis.||respiratory events/hour||Standard Deviation|Mean
638381|NCT02437903|Other Pre-specified|Number of Participants With Specific Site Treatment Responses|Site treatment response reported by subject on diary day 0-14 post initial injection and touch-up injections|Day 14|Total number of subjects that reported symptom||Participants|||Count of Participants
638382|NCT02437903|Other Pre-specified|Subject Self-Perception of Age|Subjects perception of age when the subject looks at his/her right and left temples|Baseline, month 1, month 3, month 6, month 9, and Month 12|All subjects with data for this outcome measure||Participants|||Count of Participants
638383|NCT02437903|Other Pre-specified|Subject’s Satisfaction With Temple Appearance|Subject’s Satisfaction with Temple Appearance|Baseline, month 1, month 3, month 6, month 9, and Month 12|All subjects with data for this outcome measure||Participants|||Count of Participants
638384|NCT02437903|Secondary|Investigator's Satisfaction With the Appearance of the Temporal Regions|Graded level of satisfaction with the current appearance of the temporal region making certain that the investigator is looking at the patient’s right side and not the investigator’s right side.|Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12|All subjects with data for this outcome measure||Participants|||Count of Participants
638385|NCT02437903|Primary|Frontal Temporal Fossa Rating Scale|Graded severity of the temporal line of the frontal bone (TLFB) using the Frontal Temporal Fossa Rating Scale: (these will have a picture assigned to each score.|Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12|All subjects with data for for this outcome measure||Participants|||Count of Participants
638386|NCT02437513|Other Pre-specified|Reported Subjective Rating of Comfort of the Device in the Larynx|In patient subjective measure (repeated) of pain score (1-10) and comfort level (questionnaire) at weeks 1,4,8,12|12 weeks||||||
638387|NCT02437513|Other Pre-specified|Change From Baseline of Quality of Life (QoL) Score|In patient QoL assessed at baseline and at 12 weeks using German standard QoL clinical questionnaire specifically for patients with swallowing dysfunction|12 weeks||||||
655166|NCT01955044|Secondary|LCPUFA Levels|LCPUFA levels will be measured at 8 weeks of life.|8 weeks of life|||wt% (g/100g)||Inter-Quartile Range|Median
638389|NCT02437513|Secondary|Number of Participants With an Increase of Greater Than 1 on the Heyse-Moore Score|"In patient change from baseline score of dyspnea using Heyse-Moore (Dyspnea)score:
0 = None
= Mild, some difficulty
= Moderate Difficulty but can continue
= Severe difficulty, cannot continue"|1 weeks|Second enrolled patient did not reach the first data point, subj. was explanted prior first measurement.||participants|||Number
638390|NCT02437513|Secondary|Number of Reported Adverse Events|Analysis of the the rate and severity of reported system or procedure related adverse events as a measure of safety of the device in this patient population over a 12 week period|2 weeks|||AE reported|||Number
638391|NCT02437513|Secondary|Number of Reported Adverse Events|Analysis of the reported system or procedure related adverse events using standard AE reporting form|at device implantation|||adverse events|||Number
638392|NCT02437513|Primary|Change From Baseline Per Patient of Number and Severity of Aspiration Events|In patient change from baseline measurement of aspiration severity and frequency of events at weeks 1,4,8,and 12|12 weeks|First patient: Device was explanted within 48 hours after implantation - no Data could be collected Second Patient: Due to patient's non-compliance no data could be collected.Device was explanted within two weeks after implantation.|||||
638393|NCT02437409|Secondary|No. of Passages Needed to Reach the Final TICI Score With pREset||during intervention, up to 3 hr|100 patients harboured 109 vessel occlusions||passes|vessel occlusions|Standard Deviation|Mean
638394|NCT02437409|Secondary|Recanalization of the Target Vessel|"original Thrombolysis in Cerebral Infarction score (o-TICI) The TICI scale indicates perfusion of an occluded blood vessel, it is used in angiographic imaging.
Grade 0 = no perfusion Grade 1 = Penetration with minimal perfusion. The contrast material passes beyond the area of obstruction but fails to opacify the entire cerebral bed distal to the obstruction for the duration of the angiographic run, Grade 2a = Only partial filling (<2/3) of the entire vascular territory is visualized, Grade 2b = Complete filling of all of the expected vascular territory is visualized, but the filling is slower than normal, Grade 3 = complete perfusion."|at the end of intervention, up to 3 hr|100 patients harboured 109 vessel occlusions||number of vessels|vessel occlusions||Number
638395|NCT02437409|Secondary|Time From Groin Puncture to Recanalization||during intervention, up to 3 hr|All Patients||minutes||Full Range|Median
638396|NCT02437409|Secondary|Intracranial Hemorrhage (ICH)|Intracranial hemorrhage was assessed via imaging material (e.g. Digital Subtraction Angiography - DSA or CT) as forwarded by the clinical sites.|24 hr after treatment|All Patients||patients|||Number
638397|NCT02437409|Secondary|Neurological Condition of the Patient|"The National Institutes of Health Stroke Scale (NIHSS) is a commonly used measure to assess the severity of a stroke. All items are rated and scores are added at the end. A higher score corresponds to a more severe stroke. Assessed are:
Level of Conciousness (LOC) (0-3) 1a. LOC Questions (0-2) 1b. LOC Commands (0-2)
Best Gaze (0-2)
Visual (0-3)
Facial palsy (0-3)
Motor arm (0-4)
Motor leg (0-4)
Limb ataxia (0-2)
Sensory (0-2)
Best Language (0-3)
Dysarthria (0-2)
Extinction and Inattention (0-2)
CLASSIFICATION:
0 No stroke symptoms 1-4 Minor stroke 5-15 Moderate stroke 16-20 Moderate to severe stroke 21-42 Severe stroke
As published by ninds.nih.gov: http://www.ninds.nih.gov/doctors/NIH_Stroke_Scale.pdf"|24 to 72 hr after treatment|All Patients||NIHSS score||Full Range|Median
638398|NCT02437409|Primary|Neurological Condition of the Patient|"modified Rankin Scale (mRS)
Neurological Condition is measured by the Modified Rankin Scale (mRS). This scale ranges from 0 - 6:
0 = No symptoms at all;
= able to carry out all usual duties and activities;
= unable to carry out all previous activities, but able to look after own affairs without assistance;
= requiring some help, but able to walk without assistance;
= unable to walk without assistance and unable to attend to own bodily needs without assistance;
= bedridden, incontinent and requiring constant nursing care and attention;
= dead"|90 days after treatment|All Patients||patients|||Number
638399|NCT02437344|Secondary|Withdrawal: Subjective Opioid Withdrawal Scale Scores at Baseline and Administered Subsequently||5 weeks||||||
638400|NCT02437344|Primary|Successful Naltrexone Initiation|The proportion of participants enrolled in the trial and receiving the infusion to receive XR-NTX|2 weeks|||Participants|||Count of Participants
638401|NCT02437305|Primary|Number of Participants With Correct Answers on Melanoma Perception Pre-intervention and 2 Months Post-intervention|The subject will complete 3 questionnaires: one pre-intervention, one post-intervention, and one 2 months post-intervention. Several questions will assess the participants knowledge of general melanoma, what it looks like and what are its risk factors. To determine participant retention, the pre-intervention and 2 month post-intervention questionnaires will be evaluated.|2 months post-intervention|||participants|||Number
638402|NCT02437305|Primary|Number of Participants That Performed Regular Self-Skin Examinations|The subject will complete 3 questionnaires: one pre-intervention, one immediately post-intervention and one 2 months post-intervention. 5 questions will assess whether or not the patient has completed skin-self examinations and knows which areas of the skin to pay attention to. The pre-intervention and 2 month post-intervention questionnaire will be evaluated to determine the number of participants that performed regular self-skin examinations.|2 months post-intervention|||participants|||Number
638403|NCT02437253|Secondary|Anti-ERT Antibodies|Anti-laronidase antibodies for subjects with MPS I. Anti-idursulfase antibodies for subjects with MPS II.|Day 0 to week 16 of treatment with adalimumab versus placebo|No participants had anti-ERT antibodies||Participants|||Count of Participants
638404|NCT02437253|Secondary|Range of Motion - Bilateral Shoulder, Elbow, Hip, Knee|Number of joints with a >5 degree more positive change during 16 weeks of adalimumab versus 16 weeks of placebo. A total of eight joints were measured.|Day 0 to week 16 of treatment with adalimumab versus placebo|||joints|||Number
638405|NCT02437253|Secondary|Pain Measured by the Visual Analog Scale (VAS) in the Pediatric Pain Questionnaire (PPQ)|"Percent of participants with a >10 mm improvement in either how you feel now or worst pain you had this week on the VA in the PPQ during adalimumab versus during placebo by either parental or subject report. Range is 0-100 mm; lower number means less pain."|Day 0 to week 16 of treatment with adalimumab versus placebo|||Participants|||Count of Participants
638714|NCT02430870|Secondary|AUC∞: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for TAK-648 for Part 1||Days 1 and 17 pre-dose and multiple time-points post-dose (Up to 72 hours)|The PK Set included all participants in the safety set with at least 1 measurable plasma concentration.||ng*hr/mL||Standard Deviation|Mean
641120|NCT02319824|Secondary|T Cell Transfer Based on Response Evaluation Criteria In Solid Tumors v1.1|RECIST at 6 weeks after treatment (non-radiated tumors only)|At 6 weeks post-treatment|||Participants|||Count of Participants
638406|NCT02437253|Secondary|Children's Health Questionnaire - Parent Form 50 Physical Function (PF) Standardized Score|Children's Health Questionnaire - Parent Form 50 physical function (PF) standardized score for participants < 18 years of age. Range is from 0 to 100 (no units) and standardization if determined by comparison to healthy age matched children. Lower values mean decreased physical function. The difference of change in PF standardized score from day 0 to week 16 during adalimumab treatment minus change in PF standardized score from day 0 to week 16 during placebo treatment is reported.|Day 0 to week 16 of treatment with adalimumab versus placebo|||units on a scale||Full Range|Mean
638407|NCT02437253|Primary|Children's Health Questionnaire - Parent Form 50 Bodily Pain Standardized Score|Children's Health Questionnaire - Parent Form 50 bodily pain (BP) standardized score for participants < 18 years of age. Range is from 0 to 100 (no units) and standardization if determined by comparison to healthy age matched children. Lower values mean increased pain. The difference of change in BP standardized score from day 0 to week 16 during adalimumab treatment minus change in BP standardized score from day 0 to week 16 during placebo treatment is reported.|day 0 to week 16 of treatment with adalimumab versus placebo|This was a cross-over study so within-individual changes are reported.||units on a scale||Full Range|Mean
638408|NCT02436811|Primary|Changes in the Knowledge Score|The knowledge score was assessed by nine statements developed and tested in a pilot study including items related to breastfeeding, supplemental feeding, sugar intake, bottle use, oral hygiene, and use of fluoride toothpaste. These statements were rated on a three-level Likert scale, under the following options: “agree,” “neither agree nor disagree,” and “disagree,” in addition to “I don’t know.” Each correct answer received score 1 whereas incorrect answers such as “neither agree nor disagree” and “I don’t know” were assigned score 0. The final scores ranged from 0 to 9. Higher values indicate better outcomes.|The nine statements were applied before the intervention (pre-test), after a 15-minute break, the statements were applied again (post-test). After a 4-week interval, the statement were applied once again.|||units on a scale||Standard Deviation|Mean
638409|NCT02436577|Secondary|Participants With Clinically Significant Findings in Hematology, Clinical Chemistry and Urinalysis.|Participants were assessed through each laboratory variables for any significant abnormalities. Hematology assessments included white blood cell count, red blood cell count, hemoglobin, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin and others. Clinical chemistry assessment included testing levels of sodium, potassium, urea, creatinine, albumin, calcium, glucose (fasting) and others. Urinalysis assessment included glucose, protein, blood and microscopy (if positive for blood or protein).|At Screening and at Follow-up (these two examinations are 7 to 8 weeks apart).|The safety analysis set included all participants who received at least 1 dose of ticagrelor and for whom any safety post-dose data were available.||participants|||Number
638410|NCT02436577|Secondary|Participants With Significant Findings in 12-Lead Electrocardiography (ECG).|A 12-lead ECG was obtained after the participant rested in supine position for at least 10 minutes. The study physician was to judge the overall interpretation as normal or abnormal. If abnormal, it was decided as to whether or not the abnormality was clinically significant and the reason for the abnormality was recorded.|At Screening and at Follow-up (these two examinations are 7 to 8 weeks apart).|The safety analysis set included all participants who received at least 1 dose of ticagrelor and for whom any safety post-dose data were available.||participants|||Number
638411|NCT02436577|Secondary|Mean Change From Baseline for Vital Signs in Supine Pulse Rate.|Vital signs i.e. Pulse (beats per minute [bpm]) were collected after the participant has rested in the supine position for at least 5 minutes.|At Screening and at Follow-up (these two examinations are 7 to 8 weeks apart) and during treatment periods at pre-dose and post-dose at 2, 4 and 24 hours.|The safety analysis set included all participants who received at least 1 dose of ticagrelor and for whom any safety post-dose data were available.||bpm||Standard Deviation|Mean
638412|NCT02436577|Secondary|Mean Change From Baseline for Vital Signs of Supine Blood Pressure (SBP) and Diastolic BP (DBP)|The following variables were collected after the participants had rested in the supine position for at least 5 minutes: SBP and DBP.|Day 1 (pre dose, 2 hours, and 4 hours post dose) and Day 2 (24 hours post dose).|The safety analysis set included all participants who received at least 1 dose of ticagrelor and for whom any safety post-dose data were available.||mmHg||Standard Deviation|Mean
638413|NCT02436577|Secondary|Elimination Rate Constant (Kel) of Ticagrelor and Its Active Metabolite AR-C124910XX|Comparison of kel (elimination rate constant) of ticagrelor and its active metabolite AR-C124910XX following single doses of the OD tablet - when administered with and without water - and ticagrelor IR tablet. Blood samples for the determination of plasma concentrations of both ticagrelor and its active metabolite AR-C124910XX will be collected for each treatment period: 0 hours (pre-dose) and post-dose at 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The PK analysis set consisted of all participants for whom at least 1 of the primary PK parameters, for a given analyte, was calculated for at least 2 treatment periods (where 1 of the treatment periods was the period in which the participant received the reference product [Treatment C]) and who had no major protocol deviations.||1/hour||Standard Deviation|Geometric Mean
638414|NCT02436577|Secondary|Number of Participants With Adverse Events (AEs)|An AE is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. The term AE is used generally to include any AE whether serious or non-serious. A serious AE (SAE) is an AE that fulfills one or more of the following criteria: results in death, is immediately life-threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity or substantial disruption of the ability to conduct normal life functions; is a congenital abnormality or birth defect; is an important medical event that may jeopardize the participant or may require medical intervention to prevent one of the outcomes listed above.|From the date of randomization (Day 1 of the first treatment period) until the final follow-up visit (5 to 10 days after last administration of IMP).|The safety analysis set included all participants who received at least 1 dose of ticagrelor and for whom any safety post-dose data were available.||Participants|||Number
638814|NCT02423980|Secondary|Time to Plasma Glucose > 70 mg/dL|Following treatment, plasma glucose was measured every 5 minutes. The first such measurement at which plasma glucose concentration was observed to be >70 mg/dL was reported as the time to response.|0-90 minutes|All treated subjects||minutes||Full Range|Median
638415|NCT02436577|Secondary|Ratio of Metabolite AUC to Parent AUC, Adjusted for Differences in Molecular Weights (MRAUC) of Active Metabolite AR-C124910XX|Assessment of MRAUC (Ratio of metabolite AUC to parent AUC, adjusted for differences in molecular weights) of ticagrelor and its active metabolite AR-C124910XX following single doses of the OD tablet - when administered with and without water - and ticagrelor IR tablet. Blood samples for the determination of plasma concentrations of both ticagrelor and its active metabolite AR-C124910XX will be collected for each treatment period: 0 hours (pre-dose) and post-dose at 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The PK analysis set consisted of all participants for whom at least 1 of the primary PK parameters, for a given analyte, was calculated for at least 2 treatment periods (where 1 of the treatment periods was the period in which the participant received the reference product [Treatment C]) and who had no major protocol deviations.||ratio||Geometric Coefficient of Variation|Geometric Mean
638416|NCT02436577|Secondary|Ratio of Metabolite AUC(0-t) to Parent AUC(0-t), Adjusted for Differences in Molecular Weights (MRAUC [0-t]) of Active Metabolite AR-C124910XX|Assessment of MRAUC(0-t) (Ratio of metabolite AUC(0-t) to parent AUC(0-t), adjusted for differences in molecular weights) of ticagrelor and its active metabolite AR-C124910XX following single doses of the OD tablet - when administered with and without water - and ticagrelor IR tablet. Blood samples for the determination of plasma concentrations of both ticagrelor and its active metabolite AR-C124910XX will be collected for each treatment period: 0 hours (pre-dose) and post-dose at 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The PK analysis set consisted of all participants for whom at least 1 of the primary PK parameters, for a given analyte, was calculated for at least 2 treatment periods (where 1 of the treatment periods was the period in which the participant received the reference product [Treatment C]) and who had no major protocol deviations.||ratio||Geometric Coefficient of Variation|Geometric Mean
638417|NCT02436577|Secondary|MRCmax (Ratio of Metabolite Cmax to Parent Cmax, Adjusted for Differences in Molecular Weights) of Active Metabolite AR-C124910XX|Assessment of MRCmax (ratio of metabolite Cmax to parent Cmax, adjusted for differences in molecular weights) of ticagrelor and its active metabolite AR-C124910XX following single doses of the OD tablet - when administered with and without water - and ticagrelor IR tablet. Blood samples for the determination of plasma concentrations of both ticagrelor and its active metabolite AR-C124910XX will be collected for each treatment period: 0 hours (pre-dose) and post-dose at 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The PK analysis set consisted of all participants for whom at least 1 of the primary PK parameters, for a given analyte, was calculated for at least 2 treatment periods (where 1 of the treatment periods was the period in which the participant received the reference product [Treatment C]) and who had no major protocol deviations.||ratio||Geometric Coefficient of Variation|Geometric Mean
638418|NCT02436577|Secondary|Mean Residence Time (MRT) of Ticagrelor and Its Active Metabolite AR-C124910XX|Comparison of MRT (mean residence time) of ticagrelor and its active metabolite AR-C124910XX following single doses of the OD tablet - when administered with and without water - and ticagrelor IR tablet. Blood samples for the determination of plasma concentrations of both ticagrelor and its active metabolite AR-C124910XX will be collected for each treatment period: 0 hours (pre-dose) and post-dose at 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The PK analysis set consisted of all participants for whom at least 1 of the primary PK parameters, for a given analyte, was calculated for at least 2 treatment periods (where 1 of the treatment periods was the period in which the participant received the reference product [Treatment C]) and who had no major protocol deviations.||hours||Standard Deviation|Geometric Mean
638419|NCT02436577|Secondary|Terminal Elimination Rate Constant (λz) of Ticagrelor and Its Active Metabolite, AR-C124910XX.|Comparison of terminal elimination rate constant (λz) of ticagrelor and its active metabolite AR-C124910XX following single doses of the OD tablet - when administered with and without water - and ticagrelor IR tablet. Blood samples for the determination of plasma concentrations of both ticagrelor and its active metabolite AR-C124910XX will be collected for each treatment period: 0 hours (pre-dose) and post-dose at 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The PK analysis set consisted of all participants for whom at least 1 of the primary PK parameters, for a given analyte, was calculated for at least 2 treatment periods (where 1 of the treatment periods was the period in which the participant received the reference product [Treatment C]) and who had no major protocol deviations.||1/hour||Standard Deviation|Mean
638420|NCT02436577|Secondary|Half-life Associated With Terminal Slope (λz) of a Semi-logarithmic Concentration-time Curve (t½λz) of Ticagrelor and Its Active Metabolite AR-C124910XX.|Comparison of t½λz (half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve) of ticagrelor and its active metabolite AR-C124910XX following single doses of the OD tablet - when administered with and without water - and ticagrelor IR tablet. Blood samples for the determination of plasma concentrations of both ticagrelor and its active metabolite AR-C124910XX will be collected for each treatment period: 0 hours (pre-dose) and post-dose at 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The PK analysis set consisted of all participants for whom at least 1 of the primary PK parameters, for a given analyte, was calculated for at least 2 treatment periods (where 1 of the treatment periods was the period in which the participant received the reference product [Treatment C]) and who had no major protocol deviations.||hours||Standard Deviation|Mean
638715|NCT02430870|Secondary|AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-648 for Part 2||Days 1 and 10 pre-dose and multiple time-points post-dose (Up to 72 hours)|The PK Set included all participants in the safety set with at least 1 measurable plasma concentration.||ng*hr/mL||Standard Deviation|Mean
641283|NCT02314546|Primary|Sedation Scale Score|Measured by the administering RN. Measured as: agitated, alert, calm, drowsy, asleep.|15 minutes post-sedation|participants with available data at this time point||participants|||Number
638421|NCT02436577|Secondary|Time to Reach Maximum Observed Concentration (Tmax) of Ticagrelor and Its Active Metabolite AR-C124910XX.|Comparison of tmax (Time to reach maximum observed concentration) of ticagrelor and its active metabolite AR-C124910XX following single doses of the OD tablet - when administered with and without water - and ticagrelor IR tablet. Blood samples for the determination of plasma concentrations of both ticagrelor and its active metabolite AR-C124910XX will be collected for each treatment period: 0 hours (pre-dose) and post-dose at 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The PK analysis set consisted of all participants for whom at least 1 of the primary PK parameters, for a given analyte, was calculated for at least 2 treatment periods (where 1 of the treatment periods was the period in which the participant received the reference product [Treatment C]) and who had no major protocol deviations.||hours||Full Range|Median
638422|NCT02436577|Primary|Area Under Plasma Concentration-time Curve From Zero to Infinity (AUC) of Ticagrelor and Its Active Metabolite AR-C124910XX.|Comparison of AUC (Area under plasma concentration-time curve from zero to infinity) of ticagrelor and its active metabolite AR-C124910XX following single doses of the OD tablet - when administered with and without water - and ticagrelor IR tablet. Blood samples for the determination of plasma concentrations of both ticagrelor and its active metabolite AR-C124910XX will be collected for each treatment period: 0 hours (pre-dose) and post-dose at 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The PK analysis set consisted of all participants for whom at least 1 of the primary PK parameters, for a given analyte, was calculated for at least 2 treatment periods (where 1 of the treatment periods was the period in which the participant received the reference product [Treatment C]) and who had no major protocol deviations.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
638423|NCT02436577|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Analyte Concentration AUC (0-t) of Ticagrelor and Its Active Metabolite AR-C124910XX.|Comparison of AUC(0-t) (Area under the plasma concentration-time curve from time zero to time of last quantifiable analyte concentration) of ticagrelor and its active metabolite AR-C124910XX following single doses of the OD tablet - when administered with and without water - and ticagrelor IR tablet. Blood samples for the determination of plasma concentrations of both ticagrelor and its active metabolite AR-C124910XX will be collected for each treatment period: 0 hours (pre-dose) and post-dose at 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The PK analysis set consisted of all participants for whom at least 1 of the primary PK parameters, for a given analyte, was calculated for at least 2 treatment periods (where 1 of the treatment periods was the period in which the participant received the reference product [Treatment C]) and who had no major protocol deviations.||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
638424|NCT02436577|Primary|Maximum Observed Plasma Concentration (Cmax) of Ticagrelor and Its Active Metabolite AR-C124910XX.|Comparison of Cmax (maximum observed plasma concentration) of ticagrelor and its active metabolite AR-C124910XX following single doses of the orodispersible (OD) tablet - when administered with and without water - and ticagrelor immediate-release (IR) tablet. Blood samples for the determination of plasma concentrations of both ticagrelor and its active metabolite AR-C124910XX will be collected for each treatment period: 0 hours (pre-dose) and post-dose at 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The pharmacokinetic (PK) analysis set consisted of all participants for whom at least 1 of the primary PK parameters, for a given analyte, was calculated for at least 2 treatment periods (where 1 of the treatment periods was the period in which the participant received the reference product [Treatment C]) and who had no major protocol deviations.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
638425|NCT02436330|Secondary|Shuttle Run Change in Number of Shuttle Runs|The shuttle run was completed again by participants in the Experimental group at 1 year. The shuttle run is a standardized field assessment that requires participants to run 20 meters within sequentially shortened time frames of recorded beeps.|Change in number from 6 month shuttle run at 1 year|"One year data was only collected for the participants assigned to the Exergaming and Didactic Health Teaching group. Shuttle run was completed by 20/35 participants in the Experimental group at both 6 months and 1 year. Available data was analyzed."||number of runs||95% Confidence Interval|Mean
638426|NCT02436330|Secondary|Heart Rate Change||Change from 6 month Heart rate at 1 year|"One year data was only collected for the participants assigned to the Exergaming and Didactic Health Teaching group. Heart rate data was collected at 6 month and 1 year for 27/35 of the participants. Available data was analyzed."||beats per minute||95% Confidence Interval|Mean
638427|NCT02436330|Secondary|Systolic Blood Pressure Change||Change from 6 month Systolic BP at 1 year|"One year data was only collected for the participants assigned to the Exergaming and Didactic Health Teaching group. Systolic blood pressure was only documented at 6 months and 1 year for 27/35 of the participants. Available data is what was analyzed."||mmHg||95% Confidence Interval|Mean
638428|NCT02436330|Secondary|Waist Circumference Change||Change from 6 month waist circumference at 1 year|"One year data was only collected for the participants assigned to the Exergaming and Didactic Health Teaching group. Only 25/35 participants had waist measurements collected at both 6 months and 1 year. Available data was analyzed."||cm||95% Confidence Interval|Mean
638429|NCT02436330|Secondary|Exergaming Program Component Influence on Attendance|"The experimental group will answer a questionnaire at the end of the 6 month study period, measuring the importance of specific components of the curriculum and motivators which influenced enrollment and compliance with participation. Of interest is measuring the influence of the exergaming curriculum as compared to these other factors. This is a 16-item, 3-point Likert-scale (1 = least important and 3 = most important) questionnaire created specifically for this study. Results were reported based on % of participants rating 3 ,most important, for each curriculum component."|6 months|||percentage of subjects|||Number
638716|NCT02430870|Secondary|AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-648 for Part 1||Days 1 and 17 pre-dose and multiple time-points post-dose (Up to 72 hours)|The PK Set included all participants in the safety set with at least 1 measurable plasma concentration.||ng*hr/mL||Standard Deviation|Mean
638430|NCT02436330|Secondary|Change in Dietary Intake: Number of Sugar Sweetened Beverages (Block Alive FFQ)|The Block Alive FFQ: administered at the start and at 6 months to all participants in both groups. FFQ inquires about typical dietary patterns over the previous six months. Total number of sugar sweetened beverages per day is then estimated based upon participant responses.|Change from baseline at 6 months|Missing data: Not all participants completed this survey at both time points. 27/35 from the Experimental group had complete response and 10/13 from the Active comparator group had complete response regarding sugar sweetened beverage daily intake. Analysis was completed on the available data.||servings||Standard Deviation|Mean
638431|NCT02436330|Secondary|Change in Dietary Intake: Number of Fruit Servings (Block Alive FFQ)|The Block Alive FFQ: administered at the start and at 6 months to all participants in both groups. FFQ inquires about typical dietary patterns over the previous six months. Total number of fruit servings per day is then estimated based upon participant responses.|Change from baseline at 6 months|Missing data: Not all participants completed this survey at both time points. 25/35 from the Experimental group had complete response and 9/13 from the Active comparator group had complete response regarding daily fruit intake. Analysis was completed on the available data.||Servings||Standard Deviation|Mean
638432|NCT02436330|Secondary|Change in Dietary Intake: Number of Vegetable Servings (Block Alive FFQ)|The Block Alive FFQ: administered at the start and at 6 months to all participants in both groups. FFQ inquires about typical dietary patterns over the previous six months. Total number of vegetable servings per day is then estimated based upon participant responses.|Change from baseline at 6 months|Missing data: Not all participants completed this survey at both time points. 25/35 from the Experimental group had complete response and 9/13 from the Active comparator group had complete response regarding daily vegetable intake. Analysis was completed on the available data.||servings||Standard Deviation|Mean
638433|NCT02436330|Secondary|Change in Dietary Intake: % Carbohydrates (Block Alive FFQ)|The Block Alive FFQ: administered at the start and at 6 months to all participants in both groups. FFQ inquires about typical dietary patterns over the previous six months. Total % dietary carbohydrates is then estimated based upon participant responses.|Change from baseline at 6 months|Missing data: Not all participants completed this survey at both time points. 28/35 from the Experimental group had complete response and 10/13 from the Active comparator group had complete response regarding %carbohydrates in their daily diet. Analysis was completed on the available data.||percentage of carbohydrates||Standard Deviation|Mean
638434|NCT02436330|Secondary|Change in Dietary Intake: % Fat (Block Alive FFQ)|The Block Alive FFQ: administered at the start and at 6 months to all participants in both groups. FFQ inquires about typical dietary patterns over the previous six months. Total %dietary fat intake per day is then estimated based upon participant responses.|Change from baseline at 6 months|Missing data: Not all participants completed this survey at both time points. 28/35 from the Experimental group had complete response and 10/13 from the Active comparator group had complete response regarding the %fat in their daily diet. Analysis was completed on the available data.||percentage of fat||Standard Deviation|Mean
638435|NCT02436330|Secondary|Dietary Change:Total Calorie Intake (kcal/Day) (Block Alive FFQ)|The Block Alive FFQ: administered at the start and at 6 months to all participants in both groups. FFQ inquires about typical dietary patterns over the previous six months. Total kcal/kg/day is then estimated based upon participant responses.|Change from baseline at 6 months|Missing data: Not all participants completed this survey at both time points. 28/35 from the Experimental group had complete response and 10/13 from the Active comparator group had complete response. Analysis was completed on the available data.||kcal/day||Standard Deviation|Mean
638436|NCT02436330|Secondary|Self Perception as Assessed Using the Children and Youth Physical Self-Perception Profile (CY-PSPP): Global Self-Worth Score|CY-PSPP questionnaire was completed by participants in both groups at baseline and at 6 months. Change in the Global Self-worth scores, which was 1 of 6 sub-domains, is analyzed. This sub-domain contains 6 questions with responses ranging from 1-4 for each question with 1 being the minimum and 4 being the maximum (best) score. The sub-domain score is then calculated as the mean of the 6 responses (minimum to maximum of 1 to 4).The change in score from baseline to 6 months was compared.|Change from baseline to 6 months|Missing Data: The CY-PSPP questionnaire was not completed by all participants at both the baseline visit and the 6 month mark. Therefore this analysis only includes data for participants who completed the questionnaire at both times: 26/35 from the Experimental group and 7/13 from the Active Comparator group.||scores on a scale||Standard Deviation|Mean
638437|NCT02436330|Secondary|Self Perception as Assessed Using the Children and Youth Physical Self-Perception Profile (CY-PSPP): Physical Self-Worth Changes in Physical Self-worth|CY-PSPP questionnaire was completed by participants in both groups at baseline and at 6 months. Change in the Physical Self-worth scores, which was 1 of 6 sub-domains, is analyzed. This sub-domain contains 6 questions with responses ranging from 1-4 for each question with 1 being the minimum and 4 being the maximum (best) score. The sub-domain score is then calculated as the mean of the 6 responses (minimum to maximum of 1 to 4).The change in score from baseline to 6 months was compared.|Change from baseline at 6 months|Missing Data: The CY-PSPP questionnaire was not completed by all participants at both the baseline visit and the 6 month mark. Therefore this analysis only includes data for participants who completed the questionnaire at both times: 26/35 from the Experimental group and 7/13 from the Active Comparator group.||scores on a scale||Standard Deviation|Mean
638438|NCT02436330|Secondary|Activity Levels Measured by Pedometers (Weekly Steps)|Activity will be measured by pedometers (number of steps) during week 1 and week 24 for both groups. Subjects used the Yamax 200 pedometer to count the steps they took over 1 weeks time.|Change from week 1 to week 24|Missing data: Data was not available from all participants from pedometer use at both the 1 week and 24 week mark, therefore, this analysis only includes 13/35 participant data from the Experimental group and 10/13 participant data collected from the Active comparator group.||steps||Standard Deviation|Mean
638439|NCT02436330|Secondary|Saturday Screen Time as Assessed by Questionnaire|Change in Saturday screen time (reported out as fraction of an hour) will be measured by subject response on questionnaire taken at baseline and at 6 months for both groups. Saturday screen time was defined as the amount of time spent on any screen, on an average Saturday, including: watching television, computer use (laptop, desk top, tablet) or playing video games on the television or other hand held device.|Change in hours from baseline at 6 months|"Missing Data: Survey data regarding Saturday screen time was collected from participants at baseline and again at 6 months. Not all participants completed both surveys, therefore, analysis for this outcome measure only included 28/35 participants from the Experimental group and 8/13 participants from the Active comparator group."||hours||Standard Deviation|Mean
638440|NCT02436330|Secondary|After School Screen Time as Reported on Questionnaire|Change in after school screen time (reported out as fraction of 1 hour) will be measured by subject response on questionnaire taken at baseline and at 6 months for both groups. After school screen time was defined as the amount of time spent on any screen, on the average weekday afternoon/evening, including: watching television, computer use (laptop, desk top, tablet) or playing video games on the television or other hand held device.|Change from baseline at 6 months|"Missing Data: Survey data regarding after school screen time was collected from participants at baseline and again at 6 months. Not all participants completed both surveys, therefore, analysis for this outcome measure only included 28/35 participants from the Experimental group and 8/13 participants from the Active comparator group."||hours||Standard Deviation|Mean
638441|NCT02436330|Secondary|Shuttle Run Change in Number of Shuttle Runs|The shuttle run was completed by participants at baseline (session 1) and at 6 months. The shuttle run is a standardized field assessment that requires participants to run 20 meters within sequentially shortened time frames of recorded beeps.|Change in number from baseline shuttle run at 6 months|Missing Data: Shuttle run was completed by participants at baseline and at 6 months to document the change in number of runs. Not all participants attended the 6 month measurement visit, therefore, complete data was only available on 24/35 of the Experimental group and 13/13 of the Active comparator group. Available data was analyzed.||number of runs||Standard Deviation|Mean
638442|NCT02436330|Secondary|Heart Rate Change From Baseline to 6 Months||Change from baseline at 6 months|Missing Data: Heart rate measurements at baseline and at 6 months was only available for 33/35 Experimental group participants and 12/13 Active comparator group participants. Not all participants attended the 6 month measurement/data collection visit.||beats per minute||Standard Deviation|Mean
638443|NCT02436330|Secondary|Systolic Blood Pressure Change||Change from baseline Systolic BP at 6 months|Incomplete data available for analysis. Blood pressure was taken and documented at baseline and at 6 months, however, not all participants were in attendance. Complete data was only available for 33/35 Experimental group participants and 12/13 from the Active comparator group. Available data was analyzed.||mmHg||Standard Deviation|Mean
638444|NCT02436330|Secondary|Waist Circumference Change||Change from baseline at 6 months|Incomplete data available for analysis. Change in waist circumference from baseline to 6 month measurements was only collected on 34/35 of the Experimental group and 8/13 of the Active comparator group. The other participants did not show up for the 6 month measurements.||cm||Standard Deviation|Mean
638445|NCT02436330|Primary|BMI Z-score Change|Measure was only taken on the subjects who participated in the Intervention group (exergaming combined with didactic teaching).|Change from baseline BMI z-score at 1 year|Complete data was not available for all 35 subjects for this outcome measure. BMI z-score change from baseline to 1 year was only collected on 28 of the 35 participants.||z-score||95% Confidence Interval|Mean
638446|NCT02436330|Primary|BMI Z-score Change|All subjects were asked to dress in light athletic clothing and have their weight and height measured at baseline (the first group session) and at 6 months. Research assistants were trained using guidelines from the National Health and Nutrition Examination Survey (NHANES) Anthropometry Procedures Manual and demonstrated accurate measures on 3 separate children. The Seca 217 portable stadiometer was used for all height measurements and the HealthOMeter 844 KL scale was used for all weight measurements. BMI z-scores were calculated using software available from the Children's Hospital of Philadelphia Research Institute (http://stokes.chop.edu/web/zcore).|Change from baseline at 6 months|||z-score||Standard Deviation|Mean
638447|NCT02436304|Secondary|Time to Cessation of Otorrhea|The time to cessation of otorrhea in the enrolled ear(s) was calculated as the number of days from the day of surgery to the absence of otorrhea (ie, no discharge) as reported by the parent/caregiver. Participants were considered a treatment failure if, at any time during the course of the study, an alternative therapy was initiated to treat the post-surgical infection. All participants who had missing or indeterminate outcomes were considered a failure (same as baseline observation carried forward).|Up to Day 14|ITT analysis set||days||95% Confidence Interval|Median
638448|NCT02436304|Secondary|Percentage of Subjects With Microbiological Success at Day 14|Microbiological success was attained if all pretherapy bacteria were absent in the study ear for the test-of-cure (TOC) specimen, which was presumed a success for subjects with no otorrhea at Day 14. Participants were considered a treatment failure if, at any time during the course of the study, an alternative therapy was initiated to treat the post-surgical infection. All participants who had missing or indeterminate outcomes were considered a failure (same as baseline observation carried forward).|Day 14|This analysis population includes all ITT participants who were culture-positive at Day 1 in at least 1 ear (Microbiological Intent-to-Treat (MITT) analysis set)||percentage of participants|||Number
638449|NCT02436304|Primary|Percentage of Subjects With Sustained Clinical Cure at Day 8|Sustained clinical cure was defined as the absence of otorrhea in the study ear at Day 8 (end of treatment (EOT)) per the Investigator assessment. Participants were considered a treatment failure if, at any time during the course of the study, an alternative therapy was initiated to treat the post-surgical infection. All participants who had missing or indeterminate outcomes were considered a failure (same as baseline observation carried forward).|Day 8|ITT analysis set||percentage of participants|||Number
638450|NCT02436031|Secondary|Number of Apnoea-Hypopnea Index (AHI) Events During Non-Random Eye Movement (NREM) Sleep|The AHI is the number of apneas (pauses in breathing) or hypopneas (shallow breathing) recorded during the study per hour of sleep. Data for the calculation of the AHI was collected while the participant was in NREM sleep in the supine position and off CPAP (breathing spontaneously).|1 night|All participants who were randomized, completed both study nights, and were included in the analysis. 1 participant was excluded due to insufficient sleep time.||events per hour||Inter-Quartile Range|Median
638451|NCT02436031|Secondary|Genioglossus Muscle Responsiveness to Progressively Greater Epiglottic Pressure Swings|Electromyography (EMG) was used to analyze genioglossus (GG) [EMG GG] muscle activity. EMG GG activity was recorded via standard needle electrodes inserted into the genioglossus muscle (tongue). Activity of EMG GG was measured during wakefulness and sleep as % of maximum activation obtained pushing the tongue against closed teeth during wakefulness (GG%max). Participants were connected to a modified continuous positive airway pressure (CPAP) machine (Pcrit3000, Respironics) which provided a wide range of pressures between 20 and -20 cm H2O in order to modify upper airway pressure and measure change in EMG GG as a function of epiglottic pressure (muscle responsiveness) (%max/cmH2O).|1 night|All participants who were randomized, completed both study nights, and were included in the analysis. 1 participant was excluded due to insufficient sleep time.||%max/cmH2O||Inter-Quartile Range|Median
638452|NCT02436031|Primary|Change in Pharyngeal Critical Collapsing Pressure (Pcrit) as a Measure of Upper Airway Collapsibility|Participants were connected to a modified continuous positive airway pressure (CPAP) machine (Pcrit3000, Respironics) which provided a wide range of pressures between 20 and -20 cm H2O in order to modify upper airway pressure. Following a baseline recording period of 5 minutes, the CPAP level was reduced to varying suboptimal pressures. Change in Pcrit was used to determine the collapsibility of the upper airway under both passive and active conditions, and is expressed as Passive Pcrit: ventilation at a nasal pressure of 0 cm H2O when pharyngeal muscles are passive; Active Pcrit: ventilation at a nasal pressure of 0 cm H2O when pharyngeal muscles are active. Improved=more negative Pcrit.|1 night|All participants who were randomized, completed both study nights, and were included in the analysis. 1 participant was excluded due to insufficient sleep time.||cm H2O||Inter-Quartile Range|Median
638453|NCT02435966|Secondary|Change in the Neck Disability Index Questionnaire||Pre-intervention (Day 1); after 2nd intervention (7 days)||||||
638454|NCT02435966|Secondary|Change in the Cervical Range of Motion Measured by Goniometer|Measured by goniometer, with the standard measurement procedure|Pre-intervention (Day 1); After 1st intervention (Day 1); after 2nd intervention (7 days later); after followup (30 days later)||||||
638455|NCT02435966|Secondary|Change in the Pressure Pain Threshold Measured by Algometer|Measured by algometer, with the standard measurement procedure|Pre-intervention (Day 1); After 1st intervention (Day 1); after 2nd intervention (7 days later); after followup (30 days later)||||||
638456|NCT02435966|Primary|Change in Pain Scores on the Visual Analog Scale (VAS: 0-10) After 30 Days|The Visual Analogue Scale is a validated, self-reported instrument to assess pain, with scores ranging from 0 (no pain) to 10 (maximum pain). We assess the change in chronic neck pain after 30 days, after to interventions in days 1 and 7) as compared to the baseline VAS|Pre-intervention (Day 1); After 1st intervention (Day 1); after 2nd intervention (7 days later); after followup (30 days later)|||units on a scale||Standard Deviation|Mean
638457|NCT02435836|Primary|Percentage of Participants With Laboratory Values of Potential Clinical Relevance|The laboratory values were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal values in serum chemistry, hematology, urinalyses and prolactin tests that were identified based on pre-defined criteria.|Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit|Safety Sample includes all randomized participants who receive at least one dose of study medication.||Percentage of participants|||Number
638458|NCT02435836|Primary|Percentage of Participants With ECG Measurements of Potential Clinical Relevance|The measurement of ECG was one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, QRS, QT, QTcB, and QTcF that were identified based on pre-defined criteria.|Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit|Safety Sample includes all randomized participants who receive at least one dose of study medication.||Percentage of participants|||Number
638459|NCT02435836|Primary|Percentage of Participants With Vital Signs of Potential Clinical Relevance|The vital signs were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance included abnormal values in heart rate, systolic and diastolic blood pressure, respiratory rate and weight that were identified based on pre-defined criteria.|Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit|Safety Sample includes all randomized participants who receive at least one dose of study medication.||percentage of participants|||Number
638460|NCT02435836|Primary|Number of Participants With Adverse Events (AEs)|The AEs were one of the primary parameters to measure the safety and tolerability of individual participants. The AEs were captured for all participants from the time the ICF was signed until the end of the trial.|Baseline to Last Visit|Safety Sample includes all randomized participants who receive at least one dose of study medication.||Participants|||Number
638461|NCT02435836|Primary|Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week|The AIMS assessment consisted of 10 items describing symptoms of dyskinesia. Facial and oral movements (items 1 through 4), extremity movements (items 5 and 6), and trunk movements (item 7) were observed unobtrusively while the participant was at rest (e.g., in the waiting room), and the study physician would make global judgments on the participant's dyskinesia's (items 8 through 10). For this scale, the participant was seated on a hard, firm chair. These items are rated on a five-point scale: 0 (none), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe). The total score ranges from 0 to 40. Negative changes from baseline indicate an improvement, with higher negative values indicating better improvement.|Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit|All participants who had received at least one dose of study medication were included in both efficacy and safety analyses dataset.||Units on a scale||Standard Deviation|Mean
638492|NCT02433834|Secondary|Change From Baseline in Morning Pre-dose Trough FEV1 on Day 15|Change from baseline in morning pre-dose trough FEV1 on Day 15|Day 1-Day 15 in each of 5 treatment periods|Modified Intent-to-Treat (mITT) population was a subset of the Intent-to-Treat (ITT) Population and included all subjects who received treatment, had post-treatment efficacy data from at least two treatment periods, and did not hav e a major protocol violation that would preclude the use of data from these periods.||Liter||Standard Error|Least Squares Mean
641284|NCT02314546|Primary|Sedation Scale Score|Measured by the administering RN. Measured as: agitated, alert, calm, drowsy, asleep.|10 minutes post-sedation|participants with available data at this time point||participants|||Number
638462|NCT02435836|Primary|Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week|BARS consisted of 4 items: objective observation of akathisia by study physician, subjective feelings of restlessness by participant, participant distress due to akathisia, global evaluation of akathisia. The first 3 items were rated on a 4-point scale: 0 = absence of symptoms to 3 = severe condition. The global clinical evaluation were made on a 6-point scale, (0=absent, 1=questionable, 2=mild, 3=moderate, 4=marked, 5=severe). Participants were observed while they were seated and then stood for a minimum of 2 minutes in each position. Symptoms observed in other situations (e.g., while engaged in neutral conversation or engaged in activity on the ward) may also be rated. Subjective phenomena were elicited by direct questioning. The BARS Global Score was derived from the global clinical assessment of akathisia from the BARS panel. Total score ranges from 0 to 14. Negative changes from baseline indicate improvement, with higher negative values indicating better improvement.|Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit|All participants who had received at least one dose of study medication were included in both efficacy and safety analyses dataset.||Units on a scale||Standard Deviation|Mean
638463|NCT02435836|Primary|Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week|The SAS is composed of 10 items. This scale contains 10 items: Gait, Arm dropping, Shoulder shaking, Elbow rigidity, Wrist rigidity, Head rotation, Glabella Tap, Tremor, Salivation, Akathisia. Grade of severity of each item is rated using a 5-point scale, 1 (normal) and 5 (most severe). The total score ranges from 10 to 50. Negative changes from baseline indicate an improvement, with higher negative values indicating better improvement.|Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit|All participants who had received at least one dose of study medication were included in both efficacy and safety analyses dataset.||Units on a scale||Standard Deviation|Mean
638464|NCT02435836|Primary|Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score|The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in participants with mood disorders. The questionnaire includes questions on the following symptoms. 1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. The usual cut-off points are: 0 to 6 = normal/ symptom absent, 7 to 19 = mild depression, 20 to 34 = moderate depression, >34 = severe depression.|Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit|All participants who had received at least one dose of study medication were included in both efficacy and safety analyses dataset.||Units on a scale||Standard Deviation|Mean
638465|NCT02435836|Primary|Mean Clinical Global Impression of Improvement (CGI-I) by Week|"The efficacy of trial medication were rated for each participant using the CGI-I scale. The study physician must rate the participant's total improvement whether or not it is due entirely to drug treatment. All responses were compared to the participant's condition at baseline. Response choices include: 0 = not assessed; 1 =very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5
=minimally worse; 6 = much worse; and 7 = very much worse."|Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit|All participants who had received at least one dose of study medication were included in both efficacy and safety analyses dataset.||Units on a scale||Standard Deviation|Mean
638466|NCT02435836|Primary|Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week|"The severity of illness for each participant was rated using the CGI-S scale. To assess CGI-S, the study physician answered the following question: Considering your total clinical experience with this particular population, how mentally ill is the participant at this time? Response choices included: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants."|Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit|All participants who had received at least one dose of study medication were included in both efficacy and safety analyses dataset.||Units on a scale||Standard Deviation|Mean
638467|NCT02435836|Primary|Mean Change From Baseline in PANSS Negative Sub-scale Score by Week|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS Negative Subscale ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms).|Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit|All participants who had received at least one dose of study medication were included in both efficacy and safety analyses dataset.||Units on a scale||Standard Deviation|Mean
638468|NCT02435836|Primary|Mean Change From Baseline in PANSS Positive Sub-scale Score by Week|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS positive subscale score was the sum of the rating scores for the 7 positive scale items from the PANSS panel. The 7 positive symptom constructs are delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS Positive Subscale ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms).|Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit|All participants who had received at least one dose of study medication were included in both efficacy and safety analyses dataset.||Units on a scale||Standard Deviation|Mean
638493|NCT02433834|Primary|Peak Change From Baseline in FEV1 Within 3 Hours Post-dosing on Day 15|Forced Expiratory Volume in 1 second (FEV1) within 3 hours post-dosing on Day 15|From Day 1 to Within 3 hours post dosing on Day 15 in each of 5 treatment periods|Modified Intent-to-Treat (mITT) population was a subset of the Intent-to-Treat (ITT) Population and included all subjects who received treatment, had post-treatment efficacy data from at least two treatment periods, and did not hav e a major protocol violation that would preclude the use of data from these periods.||Liter||Standard Error|Least Squares Mean
638469|NCT02435836|Primary|Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit|All participants who had received at least one dose of study medication were included in both efficacy and safety analyses dataset.||Units on a scale||Standard Deviation|Mean
638470|NCT02434939|Secondary|Incidence of Treatment Failure by Treatment Group.|Requiring more than two doses of the study medication provided for adequate pain control|120 minutes|||participants|||Number
638471|NCT02434939|Secondary|Incidence of Side Effects, Including Outlying Vital Signs|The patient will be assessed for vital signs (blood pressure, heart rate, respiratory rate, oxygen saturation), Ramsay Sedation Scale (RSS) score at 5,10,20 minutes following medication administration and then every 20 minutes until a total of 120 minutes from the first dose of study medication. outlying vital signs recorded.( systolic Blood pressure less than 90mmHg or greater than 150mmHg, Heart rate less than 50bpm or greater than 150bpm, oxygen saturation below 90%, respiratory rate below 9breaths/minute or greater than 40breaths/minute and RSS of 1 or greater than 3) The RSS was used to asses the level of agitation or sedation caused by the intervention .the scale ranges from 1(anxious/agitated) to 6( no response to stimulus-deep sedation) with 2 being the optimal (cooperative, oriented and tranquil).A checklist for side effects like airway problems, allergic reactions, salivation, dysphoria,nystagmus, respiratory/cardiac arrest, awakening hallucinations, nausea/vomiting was used|5, 10, 20, 40, 60, 80, 100, 120 minutes post drug administration|||participants|||Number
638472|NCT02434939|Secondary|Time to Maximal Analgesic Effect and Duration of Action of Ketamine|"Following dosage with study medication, the amount of time taken to demonstrate the maximal change in the patient's NRS pain score.
Maximal change in NRS pain score is to be defined as the largest change from patient's baseline pain score. Duration of maximal change is how long the patient's pain score remained at this level."|5, 10, 20, 40, 60, 80, 100, 120 minutes post drug administration|||minutes||Standard Deviation|Mean
638473|NCT02434939|Primary|Maximal Change in NRS Pain Scores as a Percentage of Baseline NRS Pain Score.|Our primary outcome measurement was the maximum change on the verbal NRS pain scale compared with their initial score (baseline). The NRS was used to measure a patient's subjective level of pain on a scale from 0 (representing no pain at all) to 10 (the worst pain imaginable) using whole numbers. The NRS score was documented just prior to the administration of the study drug (time zero). After infusion of the study drug was complete, NRS scores were documented at 5, 10, 20, and then every 20 minutes thereafter up to 120 minutes. We stopped recording NRS scores prior to 120 minutes if the patient requested a third dose of the study drug, withdrew consent or developed a severe adverse effect.|5, 10, 20,25,30, 40,45,50 60, 80, 100, 120 minutes post drug adminstration|3 patients in ketamine arm withdrew consent after 20 minutes in to the study while 1 patient in morphine arm was discontinued due to urticarial for fear of a worsened reaction if reexposed to the drug as he required a second dose||percent change from baseline NRS score.||Standard Deviation|Mean
638474|NCT02434523|Secondary|Lost to Follow up||8 weeks|number of subjects in each arm who were lost to follow up||participants|||Number
638475|NCT02434523|Secondary|Side Effects|number of patients with side effects, type of side effects|8 weeks|||participants|||Number
638476|NCT02434523|Secondary|Voice Handicap Index|Voice handicap index change in score after treatment Possible range: 0 to 40 Higher values indicate worse symptoms / outcomes|8 weeks|||units on a scale||Standard Deviation|Mean
638477|NCT02434523|Primary|Reflux Symptom Index|Reflux symptom index change in score after treatment Range possible: 0 to 45 Higher values indicate worse symptoms / outcomes|8 weeks|Patients who completed treatment and post-treatment questionnaire||units on a scale||Standard Deviation|Mean
638717|NCT02430870|Secondary|Tmax: Time to Reach Maximum Plasma Concentration (Tmax) for TAK-648 for Part 2||Days 1 and 10 pre-dose and multiple time-points post-dose (Up to 72 hours)|The PK Set included all participants in the safety set with at least 1 measurable plasma concentration.||hr||Full Range|Median
656416|NCT01937598|Secondary|AUC Plasma Glucose|Incremental AUC from 0 to 300 min|Approximately 6 weeks (range 9 - 60 days / 8.5 weeks)|||mmol/l*min||Standard Error|Mean
638487|NCT02433834|Secondary|Change From Baseline in Asthma Control Questionnaire (ACQ-5) on Day 15|The ACQ-5 measures 5 symptoms (woken at night by symptoms, wake in the morning with symptoms, limitation of daily activities, shortness of breath, and wheeze). The scale is 0-6, where 0=minimum and 6=maximum|Day 1-Day 15 in each of 5 treatment periods|Modified Intent-to-Treat (mITT) population. The modified intent-to-treat (mITT) population included all randomized patients who received at least one dose of study drug. Patients were analyzed according to the treatment they received.||Scores on a scale||Standard Error|Least Squares Mean
638488|NCT02433834|Secondary|Change From Baseline in Average Daily Rescue Medication Use Over 14 Days|Daily pre-dose PEFR and daily post-dose PEFR will each be calculated as the average of the AM and PM measurements recorded for a given day. If either the AM or PM assessment is missing, only the single measurement will be used. Analyses of average daily pre-dose PEFR, average daily post-dose PEFR, and rescue Ventolin HFA usage will use the average of the non-missing daily values recorded in the subject diaries over each week and over the last week of treatment within each period.|Day 1-Day 15 in each of 5 treatment periods|Modified Intent-to-Treat (mITT) population was a subset of the Intent-to-Treat (ITT) Population and included all subjects who received treatment, had post-treatment efficacy data from at least two treatment periods, and did not hav e a major protocol violation that would preclude the use of data from these periods.||Puffs||Standard Error|Least Squares Mean
638489|NCT02433834|Secondary|Change From Baseline in Average Daily Post-dose PEFR Over 14 Days|Daily pre-dose PEFR and daily post-dose PEFR will each be calculated as the average of the AM and PM measurements recorded for a given day. If either the AM or PM assessment is missing, only the single measurement will be used. Analyses of average daily pre-dose PEFR, average daily post-dose PEFR, and rescue Ventolin HFA usage will use the average of the non-missing daily values recorded in the subject diaries over each week and over the last week of treatment within each period.|Day 1-Day 15 in each of 5 treatment periods|Modified Intent-to-Treat (mITT) population was a subset of the Intent-to-Treat (ITT) Population and included all subjects who received treatment, had post-treatment efficacy data from at least two treatment periods, and did not hav e a major protocol violation that would preclude the use of data from these periods.||L/min||Standard Error|Least Squares Mean
638490|NCT02433834|Secondary|Change From Baseline in Average Daily Pre-dose PEFR Over 14 Days|Change from baseline in average daily pre-dose peak expiratory flow rate (PEFR) over 14 days Daily pre-dose PEFR and daily post-dose PEFR will each be calculated as the average of the AM and PM measurements recorded for a given day. If either the AM or PM assessment is missing, only the single measurement will be used. Analyses of average daily pre-dose PEFR, average daily post-dose PEFR, and rescue Ventolin HFA usage will use the average of the non-missing daily values recorded in the subject diaries over each week and over the last week of treatment within each period.|Day 1-Day 15 in each of 5 treatment periods|Modified Intent-to-Treat (mITT) population was a subset of the Intent-to-Treat (ITT) Population and included all subjects who received treatment, had post-treatment efficacy data from at least two treatment periods, and did not hav e a major protocol violation that would preclude the use of data from these periods.||L/min||Standard Error|Least Squares Mean
638491|NCT02433834|Secondary|FEV1 AUC0-3 on Day 15|FEV1 AUC0-3 is the area under the curve for the change from baseline in FEV1 calculated using the trapezoidal rule. All observed data will be used with the trapezoidal rule to calculate AUC. To aid in interpretation, all AUC values will be normalized by dividing the AUC by the time from the first to the last non-missing value (typically 3 hours).|Day 1-Day 15 in each of 5 treatment periods|Modified Intent-to-Treat (mITT) population was a subset of the Intent-to-Treat (ITT) Population and included all subjects who received treatment, had post-treatment efficacy data from at least two treatment periods, and did not hav e a major protocol violation that would preclude the use of data from these periods.||Liter||Standard Error|Least Squares Mean
648257|NCT02107014|Primary|Change in MIP-1β From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].|||pg/mL||95% Confidence Interval|Median
638494|NCT02433366|Primary|Patient's Understanding of the Disease, Bleeding Signs, What to do in Case of Bleeding and How to Deal With Emergency Situations (Measuring Physician Compliance From Patient Perspective) (Questionnaire)|The Outcome measure is summarized using the following categories; A: Patients who received the Patient Alert Card, read it and understood its content, B: Patients who completed the Patient Alert Card with the patient specific information, C: Patients who were well informed about their treatment and the actions to be taken in case of serious complications, D: Patents who knew about the anticoagulant effect of Pradaxa®, E: Patients who were well aware of the potential side effect-bruising, F: Patients who were well aware of the potential side effect-bleeding. This Outcome measure is applicable only for the Patients group.|Day 1|AF patients on treatment with Pradaxa®.||Percentage of Participants|||Number
638495|NCT02433366|Primary|Physician's Knowledge and Recommendations to Their Patients on Appropriate Dosing and Minimizing the Risk of Bleeding When Treated With Pradaxa® (Questionnaire)|"The Outcome measure is summarized using the following categories; A: Physicians who spontaneously remembered the receipt of the Patient alert card, B: Physicians who spontaneously remembered the receipt of the Prescriber Guide, C: Physicians who were satisfied with the information provided in the Prescriber guide, D: Physicians who were aware of the importance of determining and controlling of the Patients renal function for correct pradaxa dosing.
This Outcome measure is applicable only for the Physicians group."|Day 1|Physicians who were current prescribers of Pradaxa® for stroke prevention in patients with atrial fibrillation (AF)||Percentage of Participants|||Number
638496|NCT02433340|Secondary|CR Response Rate Per CDAI Criteria at Week 36|Percentage of participants achieving CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 36 (Week 24 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638497|NCT02433340|Secondary|CR Response Rate Per CDAI Criteria at Week 32|Percentage of participants achieving CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 32 (Week 20 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638498|NCT02433340|Secondary|CR Response Rate Per CDAI Criteria at Week 28|Percentage of participants achieving CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 28 (Week 16 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638499|NCT02433340|Secondary|CR Response Rate Per CDAI Criteria at Week 24|Percentage of participants achieving CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 24 (Week 12 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638500|NCT02433340|Secondary|CR Response Rate Per CDAI Criteria at Week 20|Percentage of participants achieving CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 20 (Week 8 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638501|NCT02433340|Secondary|CR Response Rate Per CDAI Criteria at Week 16|Percentage of participants achieving CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 16 (Week 4 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
677609|NCT01607203|Primary|MII Oocytes|the number of mature oocytes retrieved|3 weeks|||cumulus oocyte complex||Standard Deviation|Mean
638502|NCT02433340|Secondary|CR Response Rate Per CDAI Criteria at Week 12|Percentage of participants achieving CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 12 of Study M12-963 (considered Week 0 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638503|NCT02433340|Secondary|CR Response Rate Per CDAI Criteria at Week 8|Percentage of participants achieving CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 8 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638504|NCT02433340|Secondary|CR Response Rate Per CDAI Criteria at Week 6|Percentage of participants achieving CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 6 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638505|NCT02433340|Secondary|CR Response Rate Per CDAI Criteria at Week 4|Percentage of participants achieving CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 4 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638506|NCT02433340|Secondary|CR Response Rate Per CDAI Criteria at Week 2|Percentage of participants achieving CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 2 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638507|NCT02433340|Secondary|LDA or CR Response Rate Per CDAI at Week 36|Percentage of participants achieving LDA or CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 36 (Week 24 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638508|NCT02433340|Secondary|LDA or CR Response Rate Per CDAI at Week 32|Percentage of participants achieving LDA or CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 32 (Week 20 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638509|NCT02433340|Secondary|LDA or CR Response Rate Per CDAI at Week 28|Percentage of participants achieving LDA or CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 28 (Week 16 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638510|NCT02433340|Secondary|LDA or CR Response Rate Per CDAI at Week 24|Percentage of participants achieving LDA or CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 24 (Week 12 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638511|NCT02433340|Secondary|LDA or CR Response Rate Per CDAI at Week 20|Percentage of participants achieving LDA or CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 20 (Week 8 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638512|NCT02433340|Secondary|LDA or CR Response Rate Per CDAI at Week 16|Percentage of participants achieving LDA or CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 16 (Week 4 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638513|NCT02433340|Secondary|LDA or CR Response Rate Per CDAI at Week 12|Percentage of participants achieving LDA or CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 12 of Study M12-963 (considered Week 0 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638514|NCT02433340|Secondary|LDA or CR Response Rate Per CDAI at Week 8|Percentage of participants achieving LDA or CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 8 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638515|NCT02433340|Secondary|LDA or CR Response Rate Per CDAI at Week 6|Percentage of participants achieving LDA or CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 6 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638516|NCT02433340|Secondary|LDA or CR Response Rate Per CDAI at Week 4|Percentage of participants achieving LDA or CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 4 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638517|NCT02433340|Secondary|LDA or CR Response Rate Per CDAI at Week 2|Percentage of participants achieving LDA or CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 2 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638518|NCT02433340|Secondary|CR Response Rate Per DAS28 (hsCRP) at Week 36|Percentage of participants achieving CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 36 (Week 24 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638519|NCT02433340|Secondary|CR Response Rate Per DAS28 (hsCRP) at Week 32|Percentage of participants achieving CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 32 (Week 20 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638520|NCT02433340|Secondary|CR Response Rate Per DAS28 (hsCRP) at Week 28|Percentage of participants achieving CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 28 (Week 16 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638521|NCT02433340|Secondary|CR Response Rate Per DAS28 (hsCRP) at Week 24|Percentage of participants achieving CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 24 (Week 12 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638522|NCT02433340|Secondary|CR Response Rate Per DAS28 (hsCRP) at Week 20|Percentage of participants achieving CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 20 (Week 8 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638523|NCT02433340|Secondary|CR Response Rate Per DAS28 (hsCRP) at Week 16|Percentage of participants achieving CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 16 (Week 4 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638524|NCT02433340|Secondary|CR Response Rate Per DAS28 (hsCRP) at Week 12|Percentage of participants achieving CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 12 of Study M12-963 (considered Week 0 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638525|NCT02433340|Secondary|CR Response Rate Per DAS28 (hsCRP) at Week 8|Percentage of participants achieving CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 8 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638718|NCT02430870|Secondary|Tmax: Time to Reach Maximum Plasma Concentration (Tmax) for TAK-648 for Part 1||Days 1 and 17 pre-dose and multiple time-points post-dose (Up to 72 hours)|The PK Set included all participants in the safety set with at least 1 measurable plasma concentration.||hours (hr)||Full Range|Median
638719|NCT02430870|Secondary|Cmax: Maximum Plasma Concentration for TAK-648 for Part 2||Days 1 and 10 pre-dose and multiple time-points post-dose (Up to 72 hours)|The PK Set included all participants in the safety set with at least 1 measurable plasma concentration.||mg/mL||Standard Deviation|Mean
638526|NCT02433340|Secondary|CR Response Rate Per DAS28 (hsCRP) at Week 6|Percentage of participants achieving CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 6 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638527|NCT02433340|Secondary|CR Response Rate Per DAS28 (hsCRP) at Week 4|Percentage of participants achieving CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 4 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638528|NCT02433340|Secondary|CR Response Rate Per DAS28 (hsCRP) at Week 2|Percentage of participants achieving CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 2 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638529|NCT02433340|Secondary|LDA or CR Response Rate Per DAS28 (hsCRP) at Week 36|Percentage of participants achieving LDA or CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 36 (Week 24 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638530|NCT02433340|Secondary|LDA or CR Response Rate Per DAS28 (hsCRP) at Week 32|Percentage of participants achieving LDA or CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 32 (Week 20 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638531|NCT02433340|Secondary|LDA or CR Response Rate Per DAS28 (hsCRP) at Week 28|Percentage of participants achieving LDA or CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 28 (Week 16 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638532|NCT02433340|Secondary|LDA or CR Response Rate Per DAS28 (hsCRP) at Week 24|Percentage of participants achieving LDA or CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 24 (Week 12 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638533|NCT02433340|Secondary|LDA or CR Response Rate Per DAS28 (hsCRP) at Week 20|Percentage of participants achieving LDA or CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 20 (Week 8 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638720|NCT02430870|Secondary|Cmax: Maximum Plasma Concentration for TAK-648 for Part 1||Days 1 and 17 pre-dose and multiple time-points post-dose (Up to 72 hours)|The Pharmacokinetic (PK) Set included all participants in the safety set with at least 1 measurable plasma concentration.||ng/mL||Standard Deviation|Mean
640376|NCT02354599|Secondary|Number of Participants With Positive Response for Anti MT203 Antibody||Baseline, Hour 168, 336, Day 42, 84|The safety analysis set was defined as all participants who received the study medication.||participants|||Number
638534|NCT02433340|Secondary|LDA or CR Response Rate Per DAS28 (hsCRP) at Week 16|Percentage of participants achieving LDA or CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 16 (Week 4 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638535|NCT02433340|Secondary|LDA or CR Response Rate Per DAS28 (hsCRP) at Week 12|Percentage of participants achieving LDA or CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 12 of Study M12-963 (considered Week 0 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638536|NCT02433340|Secondary|LDA or CR Response Rate Per DAS28 (hsCRP) at Week 8|Percentage of participants achieving LDA or CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 8 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638537|NCT02433340|Secondary|LDA or CR Response Rate Per DAS28 (hsCRP) at Week 6|Percentage of participants achieving LDA or CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 6 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638538|NCT02433340|Secondary|LDA or CR Response Rate Per DAS28 (hsCRP) at Week 4|Percentage of participants achieving LDA or CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 4 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638539|NCT02433340|Secondary|Low Disease Activity (LDA) or Clinical Remission (CR) Response Rate Per DAS28 (hsCRP) at Week 2|Percentage of participants achieving LDA or CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 2 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638540|NCT02433340|Secondary|Change From Baseline in CDAI at Week 36|CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 36 (Week 24 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||units on a scale||Standard Deviation|Mean
638541|NCT02433340|Secondary|Change From Baseline in CDAI at Week 32|CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 32 (Week 20 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||units on a scale||Standard Deviation|Mean
638593|NCT02433340|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity at Week 4|The physician assessed the participant's disease activity at the time of visit using a Physician's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 4 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||units on a scale||Standard Deviation|Mean
638542|NCT02433340|Secondary|Change From Baseline in CDAI at Week 28|CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 28 (Week 16 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||units on a scale||Standard Deviation|Mean
638543|NCT02433340|Secondary|Change From Baseline in CDAI at Week 24|CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 24 (Week 12 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||units on a scale||Standard Deviation|Mean
638544|NCT02433340|Secondary|Change From Baseline in CDAI at Week 20|CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 20 (Week 8 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||units on a scale||Standard Deviation|Mean
638545|NCT02433340|Secondary|Change From Baseline in CDAI at Week 16|CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 16 (Week 4 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||units on a scale||Standard Deviation|Mean
638546|NCT02433340|Secondary|Change From Baseline in CDAI at Week 12|CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 12 of Study M12-963 (considered Week 0 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||units on a scale||Standard Deviation|Mean
638547|NCT02433340|Secondary|Change From Baseline in CDAI at Week 8|CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 8 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||units on a scale||Standard Deviation|Mean
638548|NCT02433340|Secondary|Change From Baseline in CDAI at Week 6|CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 6 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||units on a scale||Standard Deviation|Mean
638549|NCT02433340|Secondary|Change From Baseline in CDAI at Week 4|CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 4 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||units on a scale||Standard Deviation|Mean
638550|NCT02433340|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 2|CDAI is a composite index for assessing disease activity based on the summation of the counts of Tender Joint Count 28 (TJC28) and Swollen Joint Count 28 (SJC28), patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 2 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||units on a scale||Standard Deviation|Mean
638736|NCT02430090|Secondary|Number of Participants With Pain Scores on the Visual Analog Scale|Hemodynamic parameters, characteristics of sensory and motor blockade, peri-operative and postoperative visual analogue scale (VAS) pain scores, the time to the first analgesic requirement were recorded.|Up to 4 months||||||
638551|NCT02433340|Secondary|Change From Baseline in DAS28 (hsCRP) at Week 36|The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10, with higher scores indicating more disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 36 (Week 24 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||units on a scale||Standard Deviation|Mean
638552|NCT02433340|Secondary|Change From Baseline in DAS28 (hsCRP) at Week 32|The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10, with higher scores indicating more disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 32 (Week 20 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||units on a scale||Standard Deviation|Mean
638553|NCT02433340|Secondary|Change From Baseline in DAS28 (hsCRP) at Week 28|The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10, with higher scores indicating more disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 28 (Week 16 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||units on a scale||Standard Deviation|Mean
638554|NCT02433340|Secondary|Change From Baseline in DAS28 (hsCRP) at Week 24|The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10, with higher scores indicating more disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 24 (Week 12 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||units on a scale||Standard Deviation|Mean
638555|NCT02433340|Secondary|Change From Baseline in DAS28 (hsCRP) at Week 20|The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10, with higher scores indicating more disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 20 (Week 8 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||units on a scale||Standard Deviation|Mean
638556|NCT02433340|Secondary|Change From Baseline in DAS28 (hsCRP) at Week 16|The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10, with higher scores indicating more disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 16 (Week 4 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||units on a scale||Standard Deviation|Mean
638557|NCT02433340|Secondary|Change From Baseline in DAS28 (hsCRP) at Week 12|The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10, with higher scores indicating more disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 12 of Study M12-963 (considered Week 0 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||units on a scale||Standard Deviation|Mean
638558|NCT02433340|Secondary|Change From Baseline in DAS28 (hsCRP) at Week 8|The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10, with higher scores indicating more disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 8 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||units on a scale||Standard Deviation|Mean
638559|NCT02433340|Secondary|Change From Baseline in DAS28 (hsCRP) at Week 6|The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10, with higher scores indicating more disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 6 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||units on a scale||Standard Deviation|Mean
638560|NCT02433340|Secondary|Change From Baseline in DAS28 (hsCRP) at Week 4|The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10, with higher scores indicating more disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 4 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||units on a scale||Standard Deviation|Mean
638737|NCT02430090|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|The frequency and the severity (ex) of the side effects including nausea and vomiting, hypotension, pruritus, and bradycardia were recorded.|Up to 4 months|||participants|||Number
638561|NCT02433340|Secondary|Change From Baseline in Disease Activity Score 28 (DAS28[hsCRP]) at Week 2|The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10, with higher scores indicating more disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 2 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||units on a scale||Standard Deviation|Mean
638562|NCT02433340|Secondary|Change From Baseline in hsCRP at Week 36|For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 36 (Week 24 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||mg/L||Standard Deviation|Mean
638563|NCT02433340|Secondary|Change From Baseline in hsCRP at Week 32|For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 32 (Week 20 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||mg/L||Standard Deviation|Mean
638564|NCT02433340|Secondary|Change From Baseline in hsCRP at Week 28|For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 28 (Week 16 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||mg/L||Standard Deviation|Mean
638565|NCT02433340|Secondary|Change From Baseline in hsCRP at Week 24|For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 24 (Week 12 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||mg/L||Standard Deviation|Mean
638566|NCT02433340|Secondary|Change From Baseline in hsCRP at Week 20|For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 20 (Week 8 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||mg/L||Standard Deviation|Mean
638567|NCT02433340|Secondary|Change From Baseline in hsCRP at Week 16|For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 16 (Week 4 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||mg/L||Standard Deviation|Mean
638568|NCT02433340|Secondary|Change From Baseline in hsCRP at Week 12|For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 12 of Study M12-963 (considered Week 0 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||mg/L||Standard Deviation|Mean
638569|NCT02433340|Secondary|Change From Baseline in hsCRP at Week 8|For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 8 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||mg/L||Standard Deviation|Mean
638570|NCT02433340|Secondary|Change From Baseline in hsCRP at Week 6|For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 6 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||mg/L||Standard Deviation|Mean
638571|NCT02433340|Secondary|Change From Baseline in hsCRP at Week 4|For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 4 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||mg/L||Standard Deviation|Mean
638572|NCT02433340|Secondary|Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP) at Week 2|For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 2 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||mg/L||Standard Deviation|Mean
638573|NCT02433340|Secondary|Change From Baseline in HAQ-DI at Week 36|HAQ-DI is a self-reported participant outcome measurement. It is calculated as the mean of the scores from 8 following categories with a range 0 – 3: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. The higher the score, the more likely to associate with morbidity and mortality for the participant. The minimum clinically important difference in HAQ-DI was defined as change from baseline ≤ –0.22. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 36 (Week 24 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||units on a scale||Standard Deviation|Mean
638574|NCT02433340|Secondary|Change From Baseline in HAQ-DI at Week 32|HAQ-DI is a self-reported participant outcome measurement. It is calculated as the mean of the scores from 8 following categories with a range 0 – 3: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. The higher the score, the more likely to associate with morbidity and mortality for the participant. The minimum clinically important difference in HAQ-DI was defined as change from baseline ≤ –0.22. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 32 (Week 20 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||units on a scale||Standard Deviation|Mean
638738|NCT02429258|Secondary|Change in Static Insulin Secretion Rate (10^-9 Min^-1) From Baseline to Week 4 – ITT Population||Baseline to Week 4|||10^-9 min^-1||Standard Error|Least Squares Mean
638739|NCT02429258|Secondary|Change in 2-hour Mean Weighted PPG (After the Standardized Breakfast Meal) From Baseline to Week 4||Baseline to Week 4|||mg/dL||Standard Error|Least Squares Mean
638575|NCT02433340|Secondary|Change From Baseline in HAQ-DI at Week 28|HAQ-DI is a self-reported participant outcome measurement. It is calculated as the mean of the scores from 8 following categories with a range 0 – 3: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. The higher the score, the more likely to associate with morbidity and mortality for the participant. The minimum clinically important difference in HAQ-DI was defined as change from baseline ≤ –0.22. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 28 (Week 16 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||units on a scale||Standard Deviation|Mean
638576|NCT02433340|Secondary|Change From Baseline in HAQ-DI at Week 24|HAQ-DI is a self-reported participant outcome measurement. It is calculated as the mean of the scores from 8 following categories with a range 0 – 3: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. The higher the score, the more likely to associate with morbidity and mortality for the participant. The minimum clinically important difference in HAQ-DI was defined as change from baseline ≤ –0.22. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 24 (Week 12 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||units on a scale||Standard Deviation|Mean
638577|NCT02433340|Secondary|Change From Baseline in HAQ-DI at Week 20|HAQ-DI is a self-reported participant outcome measurement. It is calculated as the mean of the scores from 8 following categories with a range 0 – 3: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. The higher the score, the more likely to associate with morbidity and mortality for the participant. The minimum clinically important difference in HAQ-DI was defined as change from baseline ≤ –0.22. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 20 (Week 8 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||units on a scale||Standard Deviation|Mean
638578|NCT02433340|Secondary|Change From Baseline in HAQ-DI at Week 16|HAQ-DI is a self-reported participant outcome measurement. It is calculated as the mean of the scores from 8 following categories with a range 0 – 3: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. The higher the score, the more likely to associate with morbidity and mortality for the participant. The minimum clinically important difference in HAQ-DI was defined as change from baseline ≤ –0.22. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 16 (Week 4 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||units on a scale||Standard Deviation|Mean
638579|NCT02433340|Secondary|Change From Baseline in HAQ-DI at Week 12|HAQ-DI is a self-reported participant outcome measurement. It is calculated as the mean of the scores from 8 following categories with a range 0 – 3: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. The higher the score, the more likely to associate with morbidity and mortality for the participant. The minimum clinically important difference in HAQ-DI was defined as change from baseline ≤ –0.22. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 12 of Study M12-963 (considered Week 0 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||units on a scale||Standard Deviation|Mean
638580|NCT02433340|Secondary|Change From Baseline in HAQ-DI at Week 8|HAQ-DI is a self-reported participant outcome measurement. It is calculated as the mean of the scores from 8 following categories with a range 0 – 3: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. The higher the score, the more likely to associate with morbidity and mortality for the participant. The minimum clinically important difference in HAQ-DI was defined as change from baseline ≤ –0.22. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 8 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||units on a scale||Standard Deviation|Mean
638581|NCT02433340|Secondary|Change From Baseline in HAQ-DI at Week 6|HAQ-DI is a self-reported participant outcome measurement. It is calculated as the mean of the scores from 8 following categories with a range 0 – 3: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. The higher the score, the more likely to associate with morbidity and mortality for the participant. The minimum clinically important difference in HAQ-DI was defined as change from baseline ≤ –0.22. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 6 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||units on a scale||Standard Deviation|Mean
638582|NCT02433340|Secondary|Change From Baseline in HAQ-DI at Week 4|HAQ-DI is a self-reported participant outcome measurement. It is calculated as the mean of the scores from 8 following categories with a range 0 – 3: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. The higher the score, the more likely to associate with morbidity and mortality for the participant. The minimum clinically important difference in HAQ-DI was defined as change from baseline ≤ –0.22. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 4 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||units on a scale||Standard Deviation|Mean
638594|NCT02433340|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity at Week 2|The physician assessed the participant's disease activity at the time of visit using a Physician's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 2 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||units on a scale||Standard Deviation|Mean
638583|NCT02433340|Secondary|Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 2|HAQ-DI is a self-reported participant outcome measurement. It is calculated as the mean of the scores from 8 following categories with a range 0 – 3: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. The higher the score, the more likely to associate with morbidity and mortality for the participant. The minimum clinically important difference in HAQ-DI was defined as change from baseline ≤ –0.22. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 2 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||units on a scale||Standard Deviation|Mean
638584|NCT02433340|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity at Week 36|The physician assessed the participant's disease activity at the time of visit using a Physician's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 36 (Week 24 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||units on a scale||Standard Deviation|Mean
638585|NCT02433340|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity at Week 32|The physician assessed the participant's disease activity at the time of visit using a Physician's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 32 (Week 20 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||units on a scale||Standard Deviation|Mean
638586|NCT02433340|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity at Week 28|The physician assessed the participant's disease activity at the time of visit using a Physician's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 28 (Week 16 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||units on a scale||Standard Deviation|Mean
638587|NCT02433340|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity at Week 24|The physician assessed the participant's disease activity at the time of visit using a Physician's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 24 (Week 12 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||units on a scale||Standard Deviation|Mean
638588|NCT02433340|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity at Week 20|The physician assessed the participant's disease activity at the time of visit using a Physician's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 20 (Week 8 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||units on a scale||Standard Deviation|Mean
638589|NCT02433340|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity at Week 16|The physician assessed the participant's disease activity at the time of visit using a Physician's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 16 (Week 4 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||units on a scale||Standard Deviation|Mean
638590|NCT02433340|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity at Week 12|The physician assessed the participant's disease activity at the time of visit using a Physician's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 12 of Study M12-963 (considered Week 0 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||units on a scale||Standard Deviation|Mean
638591|NCT02433340|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity at Week 8|The physician assessed the participant's disease activity at the time of visit using a Physician's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 8 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||units on a scale||Standard Deviation|Mean
638592|NCT02433340|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity at Week 6|The physician assessed the participant's disease activity at the time of visit using a Physician's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 6 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||units on a scale||Standard Deviation|Mean
638740|NCT02429258|Secondary|Change in Fructosamine From Baseline to Week 4||Baseline to Week 4|||mmol/L||Standard Error|Least Squares Mean
638741|NCT02429258|Secondary|Change in HbA1c From Baseline to Week 4||Baseline to Week 4|||% Alc||Standard Error|Least Squares Mean
678520|NCT01596842|Primary|25-hydroxyvitamin D Levels at 12 Weeks||12 weeks|||ng/ml||Standard Deviation|Mean
638595|NCT02433340|Secondary|Change From Baseline in Patient's Global Assessment of Disease Activity at Week 36|Participants assessed their disease activity for the past 24 hours using a Patient's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 36 (Week 24 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||units on a scale||Standard Deviation|Mean
638596|NCT02433340|Secondary|Change From Baseline in Patient's Global Assessment of Disease Activity at Week 32|Participants assessed their disease activity for the past 24 hours using a Patient's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 32 (Week 20 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||units on a scale||Standard Deviation|Mean
638597|NCT02433340|Secondary|Change From Baseline in Patient's Global Assessment of Disease Activity at Week 28|Participants assessed their disease activity for the past 24 hours using a Patient's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 28 (Week 16 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||units on a scale||Standard Deviation|Mean
638598|NCT02433340|Secondary|Change From Baseline in Patient's Global Assessment of Disease Activity at Week 24|Participants assessed their disease activity for the past 24 hours using a Patient's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 24 (Week 12 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||units on a scale||Standard Deviation|Mean
638599|NCT02433340|Secondary|Change From Baseline in Patient's Global Assessment of Disease Activity at Week 20|Participants assessed their disease activity for the past 24 hours using a Patient's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 20 (Week 8 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||units on a scale||Standard Deviation|Mean
638600|NCT02433340|Secondary|Change From Baseline in Patient's Global Assessment of Disease Activity at Week 16|Participants assessed their disease activity for the past 24 hours using a Patient's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 16 (Week 4 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||units on a scale||Standard Deviation|Mean
638601|NCT02433340|Secondary|Change From Baseline in Patient's Global Assessment of Disease Activity at Week 12|Participants assessed their disease activity for the past 24 hours using a Patient's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 12 of Study M12-963 (considered Week 0 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||units on a scale||Standard Deviation|Mean
638602|NCT02433340|Secondary|Change From Baseline in Patient's Global Assessment of Disease Activity at Week 8|Participants assessed their disease activity for the past 24 hours using a Patient's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 8 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||units on a scale||Standard Deviation|Mean
638603|NCT02433340|Secondary|Change From Baseline in Patient's Global Assessment of Disease Activity at Week 6|Participants assessed their disease activity for the past 24 hours using a Patient's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 6 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||units on a scale||Standard Deviation|Mean
638604|NCT02433340|Secondary|Change From Baseline in Patient's Global Assessment of Disease Activity at Week 4|Participants assessed their disease activity for the past 24 hours using a Patient's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 4 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||units on a scale||Standard Deviation|Mean
638605|NCT02433340|Secondary|Change From Baseline in Patient's Global Assessment of Disease Activity at Week 2|Participants assessed their disease activity for the past 24 hours using a Patient's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 2 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||units on a scale||Standard Deviation|Mean
638606|NCT02433340|Secondary|Change From Baseline in Patient's Assessment of Pain at Week 36|Participants assessed their pain in the previous week using a Patient's Global Assessment Pain VAS. The range is 0 to 100 mm with no pain being indicated by 0 and severe pain by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 36 (Week 24 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||units on a scale||Standard Deviation|Mean
638607|NCT02433340|Secondary|Change From Baseline in Patient's Assessment of Pain at Week 32|Participants assessed their pain in the previous week using a Patient's Global Assessment Pain VAS. The range is 0 to 100 mm with no pain being indicated by 0 and severe pain by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 32 (Week 20 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||units on a scale||Standard Deviation|Mean
638608|NCT02433340|Secondary|Change From Baseline in Patient's Assessment of Pain at Week 28|Participants assessed their pain in the previous week using a Patient's Global Assessment Pain VAS. The range is 0 to 100 mm with no pain being indicated by 0 and severe pain by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 28 (Week 16 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||units on a scale||Standard Deviation|Mean
638609|NCT02433340|Secondary|Change From Baseline in Patient's Assessment of Pain at Week 24|Participants assessed their pain in the previous week using a Patient's Global Assessment Pain VAS. The range is 0 to 100 mm with no pain being indicated by 0 and severe pain by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 24 (Week 12 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||units on a scale||Standard Deviation|Mean
638610|NCT02433340|Secondary|Change From Baseline in Patient's Assessment of Pain at Week 20|Participants assessed their pain in the previous week using a Patient's Global Assessment Pain VAS. The range is 0 to 100 mm with no pain being indicated by 0 and severe pain by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 20 (Week 8 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||units on a scale||Standard Deviation|Mean
638611|NCT02433340|Secondary|Change From Baseline in Patient's Assessment of Pain at Week 16|Participants assessed their pain in the previous week using a Patient's Global Assessment Pain VAS. The range is 0 to 100 mm with no pain being indicated by 0 and severe pain by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 16 (Week 4 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||units on a scale||Standard Deviation|Mean
638612|NCT02433340|Secondary|Change From Baseline in Patient's Assessment of Pain at Week 12|Participants assessed their pain in the previous week using a Patient's Global Assessment Pain VAS. The range is 0 to 100 mm with no pain being indicated by 0 and severe pain by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 12 of Study M12-963 (considered Week 0 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||units on a scale||Standard Deviation|Mean
638613|NCT02433340|Secondary|Change From Baseline in Patient's Assessment of Pain at Week 8|Participants assessed their pain in the previous week using a Patient's Global Assessment Pain VAS. The range is 0 to 100 mm with no pain being indicated by 0 and severe pain by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 8 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||units on a scale||Standard Deviation|Mean
638614|NCT02433340|Secondary|Change From Baseline in Patient's Assessment of Pain at Week 6|Participants assessed their pain in the previous week using a Patient's Global Assessment Pain VAS. The range is 0 to 100 mm with no pain being indicated by 0 and severe pain by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 6 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||units on a scale||Standard Deviation|Mean
638615|NCT02433340|Secondary|Change From Baseline in Patient's Assessment of Pain at Week 4|Participants assessed their pain in the previous week using a Patient's Global Assessment Pain VAS. The range is 0 to 100 mm with no pain being indicated by 0 and severe pain by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 4 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||units on a scale||Standard Deviation|Mean
638616|NCT02433340|Secondary|Change From Baseline in Patient's Assessment of Pain at Week 2|Participants assessed their pain in the previous week using a Patient's Global Assessment Pain visual analogue scale (VAS). The range is 0 to 100 mm with no pain being indicated by 0 and severe pain by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 2 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had a baseline and post-baseline assessment. LOCF was used for missing data; LOCF imputation was conducted separately for M12-963 and M12-965 (ie, data from M12-963 was not carried forward to visits in M12-965).||units on a scale||Standard Deviation|Mean
638742|NCT02429258|Secondary|Change in 4-hour Mean Weighted Post-prandial Glucose (PPG) (After the Standardized Breakfast Meal) From Baseline to Week 4||Baseline to Week 4|||mg/dL||Standard Error|Least Squares Mean
638743|NCT02429258|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 4||Baseline to Week 4|||mg/dL||Standard Error|Least Squares Mean
638617|NCT02433340|Secondary|Change From Baseline in SJC66 at Week 36|"At each study visit, a joint evaluator assessed whether a particular joint was swollen where presence of swelling was scored as 1 and the absence of swelling was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total SJC66, which is based on 66 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 was 0 to 66, with a higher score indicating a greater degree of swelling. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963."|Week 36 (Week 24 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||swollen joints||Standard Deviation|Mean
638618|NCT02433340|Secondary|Change From Baseline in SJC66 at Week 32|"At each study visit, a joint evaluator assessed whether a particular joint was swollen where presence of swelling was scored as 1 and the absence of swelling was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total SJC66, which is based on 66 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 was 0 to 66, with a higher score indicating a greater degree of swelling. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963."|Week 32 (Week 20 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||swollen joints||Standard Deviation|Mean
638619|NCT02433340|Secondary|Change From Baseline in SJC66 at Week 28|"At each study visit, a joint evaluator assessed whether a particular joint was swollen where presence of swelling was scored as 1 and the absence of swelling was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total SJC66, which is based on 66 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 was 0 to 66, with a higher score indicating a greater degree of swelling. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963."|Week 28 (Week 16 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||swollen joints||Standard Deviation|Mean
638620|NCT02433340|Secondary|Change From Baseline in SJC66 at Week 24|"At each study visit, a joint evaluator assessed whether a particular joint was swollen where presence of swelling was scored as 1 and the absence of swelling was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total SJC66, which is based on 66 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 was 0 to 66, with a higher score indicating a greater degree of swelling. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963."|Week 24 (Week 12 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||swollen joints||Standard Deviation|Mean
638621|NCT02433340|Secondary|Change From Baseline in SJC66 at Week 20|"At each study visit, a joint evaluator assessed whether a particular joint was swollen where presence of swelling was scored as 1 and the absence of swelling was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total SJC66, which is based on 66 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 was 0 to 66, with a higher score indicating a greater degree of swelling. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963."|Week 20 (Week 8 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||swollen joints||Standard Deviation|Mean
638622|NCT02433340|Secondary|Change From Baseline in SJC66 at Week 16|"At each study visit, a joint evaluator assessed whether a particular joint was swollen where presence of swelling was scored as 1 and the absence of swelling was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total SJC66, which is based on 66 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 was 0 to 66, with a higher score indicating a greater degree of swelling. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963."|Week 16 (Week 4 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||swollen joints||Standard Deviation|Mean
638623|NCT02433340|Secondary|Change From Baseline in SJC66 at Week 12|"At each study visit, a joint evaluator assessed whether a particular joint was swollen where presence of swelling was scored as 1 and the absence of swelling was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total SJC66, which is based on 66 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 was 0 to 66, with a higher score indicating a greater degree of swelling. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963."|Week 12 of Study M12-963 (considered Week 0 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||swollen joints||Standard Deviation|Mean
638624|NCT02433340|Secondary|Change From Baseline in SJC66 at Week 8|"At each study visit, a joint evaluator assessed whether a particular joint was swollen where presence of swelling was scored as 1 and the absence of swelling was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total SJC66, which is based on 66 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 was 0 to 66, with a higher score indicating a greater degree of swelling. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963."|Week 8 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||swollen joints||Standard Deviation|Mean
638625|NCT02433340|Secondary|Change From Baseline in SJC66 at Week 6|"At each study visit, a joint evaluator assessed whether a particular joint was swollen where presence of swelling was scored as 1 and the absence of swelling was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total SJC66, which is based on 66 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 was 0 to 66, with a higher score indicating a greater degree of swelling. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963."|Week 6 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||swollen joints||Standard Deviation|Mean
638626|NCT02433340|Secondary|Change From Baseline in SJC66 at Week 4|"At each study visit, a joint evaluator assessed whether a particular joint was swollen where presence of swelling was scored as 1 and the absence of swelling was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total SJC66, which is based on 66 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 was 0 to 66, with a higher score indicating a greater degree of swelling. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963."|Week 4 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||swollen joints||Standard Deviation|Mean
638627|NCT02433340|Secondary|Change From Baseline in Swollen Joint Count (SJC66) at Week 2|"At each study visit, a joint evaluator assessed whether a particular joint was swollen where presence of swelling was scored as 1 and the absence of swelling was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total SJC66, which is based on 66 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 was 0 to 66, with a higher score indicating a greater degree of swelling. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963."|Week 2 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||swollen joints||Standard Deviation|Mean
638628|NCT02433340|Secondary|Change From Baseline in TJC68 at Week 36|"At each study visit, a joint evaluator assessed whether a particular joint was tender or painful where presence of tenderness was scored as 1 and the absence of tenderness was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total TJC68, which is based on 68 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for TJC68 was 0 to 68, with a higher score indication a greater degree of tenderness. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963."|Week 36 (Week 24 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||tender joints||Standard Deviation|Mean
638629|NCT02433340|Secondary|Change From Baseline in TJC68 at Week 32|"At each study visit, a joint evaluator assessed whether a particular joint was tender or painful where presence of tenderness was scored as 1 and the absence of tenderness was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total TJC68, which is based on 68 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for TJC68 was 0 to 68, with a higher score indication a greater degree of tenderness. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963."|Week 32 (Week 20 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||tender joints||Standard Deviation|Mean
638630|NCT02433340|Secondary|Change From Baseline in TJC68 at Week 28|"At each study visit, a joint evaluator assessed whether a particular joint was tender or painful where presence of tenderness was scored as 1 and the absence of tenderness was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total TJC68, which is based on 68 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for TJC68 was 0 to 68, with a higher score indication a greater degree of tenderness. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963."|Week 28 (Week 16 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||tender joints||Standard Deviation|Mean
638631|NCT02433340|Secondary|Change From Baseline in TJC68 at Week 24|"At each study visit, a joint evaluator assessed whether a particular joint was tender or painful where presence of tenderness was scored as 1 and the absence of tenderness was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total TJC68, which is based on 68 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for TJC68 was 0 to 68, with a higher score indication a greater degree of tenderness. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963."|Week 24 (Week 12 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||tender joints||Standard Deviation|Mean
638649|NCT02433340|Primary|ACR70 Response Rate at Week 4|Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 4 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638744|NCT02429258|Secondary|Change in Percentage of CGM Readings Over 24-hours With Plasma Glucose >180 mg/dL From Baseline to Week 4 – ITT Population||Baseline to Week 4|||Change in percentage||Standard Error|Least Squares Mean
638632|NCT02433340|Secondary|Change From Baseline in TJC68 at Week 20|"At each study visit, a joint evaluator assessed whether a particular joint was tender or painful where presence of tenderness was scored as 1 and the absence of tenderness was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total TJC68, which is based on 68 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for TJC68 was 0 to 68, with a higher score indication a greater degree of tenderness. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963."|Week 20 (Week 8 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||tender joints||Standard Deviation|Mean
638633|NCT02433340|Secondary|Change From Baseline in TJC68 at Week 16|"At each study visit, a joint evaluator assessed whether a particular joint was tender or painful where presence of tenderness was scored as 1 and the absence of tenderness was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total TJC68, which is based on 68 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for TJC68 was 0 to 68, with a higher score indication a greater degree of tenderness. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963."|Week 16 (Week 4 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||tender joints||Standard Deviation|Mean
638634|NCT02433340|Secondary|Change From Baseline in TJC68 at Week 12|"At each study visit, a joint evaluator assessed whether a particular joint was tender or painful where presence of tenderness was scored as 1 and the absence of tenderness was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total TJC68, which is based on 68 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for TJC68 was 0 to 68, with a higher score indication a greater degree of tenderness. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963."|Week 12 of Study M12-963 (considered Week 0 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||tender joints||Standard Deviation|Mean
638635|NCT02433340|Secondary|Change From Baseline in TJC68 at Week 8|"At each study visit, a joint evaluator assessed whether a particular joint was tender or painful where presence of tenderness was scored as 1 and the absence of tenderness was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total TJC68, which is based on 68 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for TJC68 was 0 to 68, with a higher score indication a greater degree of tenderness. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963."|Week 8 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||tender joints||Standard Deviation|Mean
638636|NCT02433340|Secondary|Change From Baseline in TJC68 at Week 6|"At each study visit, a joint evaluator assessed whether a particular joint was tender or painful where presence of tenderness was scored as 1 and the absence of tenderness was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total TJC68, which is based on 68 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for TJC68 was 0 to 68, with a higher score indication a greater degree of tenderness. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963."|Week 6 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||tender joints||Standard Deviation|Mean
638637|NCT02433340|Secondary|Change From Baseline in TJC68 at Week 4|"At each study visit, a joint evaluator assessed whether a particular joint was tender or painful where presence of tenderness was scored as 1 and the absence of tenderness was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total TJC68, which is based on 68 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for TJC68 was 0 to 68, with a higher score indication a greater degree of tenderness. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963."|Week 4 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||tender joints||Standard Deviation|Mean
638638|NCT02433340|Secondary|Change From Baseline In Tender Joint Count (TJC68) at Week 2|"At each study visit, a joint evaluator assessed whether a particular joint was tender or painful where presence of tenderness was scored as 1 and the absence of tenderness was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total TJC68, which is based on 68 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for TJC68 was 0 to 68, with a higher score indication a greater degree of tenderness. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963."|Week 2 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||tender joints||Standard Deviation|Mean
638650|NCT02433340|Primary|ACR70 Response Rate at Week 2|Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 2 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
661416|NCT01841567|Primary|Minimize the Risk of the Development of Blistering.|Number of participants without blisters at study visit|7 days|||participants|||Number
638639|NCT02433340|Primary|Summary of Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Discontinuation, and Deaths|An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. An SAE is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.|from the first dose of study drug in study M12-965 until 70 days after the last dose of study drug (up to 32 weeks)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965.||Participants|||Count of Participants
638640|NCT02433340|Primary|ACR70 Response Rate at Week 36|Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 36 (Week 24 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638641|NCT02433340|Primary|ACR70 Response Rate at Week 32|Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 32 (Week 20 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638642|NCT02433340|Primary|ACR70 Response Rate at Week 28|Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 28 (Week 16 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638643|NCT02433340|Primary|ACR70 Response Rate at Week 24|Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 24 (Week 12 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638644|NCT02433340|Primary|ACR70 Response Rate at Week 20|Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 20 (Week 8 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638645|NCT02433340|Primary|ACR70 Response Rate at Week 16|Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 16 (Week 4 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638646|NCT02433340|Primary|ACR70 Response Rate at Week 12|Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 12 of Study M12-963 (considered Week 0 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638647|NCT02433340|Primary|ACR70 Response Rate at Week 8|Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 8 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638648|NCT02433340|Primary|ACR70 Response Rate at Week 6|Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 6 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638651|NCT02433340|Primary|ACR50 Response Rate at Week 36|Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 36 (Week 24 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638652|NCT02433340|Primary|ACR50 Response Rate at Week 32|Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 32 (Week 20 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638653|NCT02433340|Primary|ACR50 Response Rate at Week 28|Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 28 (Week 16 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638654|NCT02433340|Primary|ACR50 Response Rate at Week 24|Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 24 (Week 12 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638655|NCT02433340|Primary|ACR50 Response Rate at Week 20|Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 20 (Week 8 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638656|NCT02433340|Primary|ACR50 Response Rate at Week 16|Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 16 (Week 4 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638657|NCT02433340|Primary|ACR50 Response Rate at Week 12|Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 12 of Study M12-963 (considered Week 0 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638658|NCT02433340|Primary|ACR50 Response Rate at Week 8|Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 8 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638659|NCT02433340|Primary|ACR50 Response Rate at Week 6|Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 6 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638660|NCT02433340|Primary|ACR50 Response Rate at Week 4|Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 4 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638661|NCT02433340|Primary|ACR50 Response Rate at Week 2|Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 2 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638662|NCT02433340|Primary|ACR20 Response Rate at Week 36|Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 36 (Week 24 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638663|NCT02433340|Primary|ACR20 Response Rate at Week 32|Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 32 (Week 20 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638664|NCT02433340|Primary|ACR20 Response Rate at Week 28|Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 28 (Week 16 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638665|NCT02433340|Primary|ACR20 Response Rate at Week 24|Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 24 (Week 12 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638666|NCT02433340|Primary|ACR20 Response Rate at Week 20|Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 20 (Week 8 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638667|NCT02433340|Primary|ACR20 Response Rate at Week 16|Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 16 (Week 4 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638668|NCT02433340|Primary|ACR20 Response Rate at Week 12|Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 12 of Study M12-963 (considered Week 0 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638669|NCT02433340|Primary|ACR20 Response Rate at Week 8|Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 8 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638670|NCT02433340|Primary|ACR20 Response Rate at Week 6|Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 6 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638671|NCT02433340|Primary|ACR20 Response Rate at Week 4|Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 4 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.||percentage of participants||95% Confidence Interval|Number
638685|NCT02431754|Secondary|Percentage of Participants With Global Impression of Improvement (PGI-I)|The PGI I is a participant rated instrument that measures the improvement or worsening of the subject’s symptoms based on a 7 point scale. A score of “1” indicates that the subject feels his symptoms are “very much better.” A score of “4” indicates that the subjects feels “no change” in his symptoms and a score of “7” indicates that the subject feels his symptoms are “very much worse.” The percentage of participants who reported a PGI-I score of 1 to 3 are presented in the table below.|Week 8|All randomized participants who received at least one dose of study drug and had a baseline and post baseline PGI-I measurement.||percentage of participants|||Number
638672|NCT02433340|Primary|American College of Rheumatology (ACR) 20 Response Rate at Week 2|Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in tender joint count (TJC68), swollen joint count (SJC66), and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, patient's global assessment of disease activity (PtGA); physician's global assessment of disease activity (PGA), Health Assessment Questionnaire - Disability Index (HAQ-DI), and high-sensitivity C-reactive protein (hsCRP). Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 2 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. Last observation carried forward (LOCF) was used for missing data.||percentage of participants||95% Confidence Interval|Number
638673|NCT02432105|Secondary|Time to Cessation of Otorrhea|Time (in days) to the cessation of otorrhea in the enrolled ear(s) was calculated as the number of days from the day of surgery to the absence of otorrhea (ie, no discharge) as reported by the parent/caregiver via the BID diary. Participants were considered a treatment failure if, at any time during the course of the study, an alternative therapy was initiated to treat the postsurgical infection. All participants with missing or indeterminate outcomes were considered a failure (same as baseline observation carried forward).|Up to Day 14|ITT analysis set||days||95% Confidence Interval|Median
638674|NCT02432105|Secondary|Percentage of Subjects With Microbiological Success at Day 14|Microbiological success was attained if all pretherapy bacteria were absent in the study ear for the Test-of-Cure (TOC) (Day 14) specimen. Participants were considered a treatment failure if, at any time during the study, an alternative therapy was initiated to treat the postsurgical infection. All participants with missing or indeterminate outcomes were considered a failure (same as baseline observation carried forward).|Day 14|This analysis population includes all ITT subjects who were culture-positive at Day 1 in at least 1 ear (Microbiological Intent-to-Treat (MITT) analysis set).||percentage of participants|||Number
638675|NCT02432105|Primary|Percentage of Subjects With Sustained Clinical Cure at Day 8|A sustained clinical cure was attained if otorrhea was absent in the study ear at Day 8 (EOT) per the Investigator assessment and continued to be absent through the end of the study. Participants were considered a treatment failure if, at any time during the study, an alternative therapy was initiated to treat the postsurgical infection. All participants with missing or indeterminate outcomes were considered a failure (same as baseline observation carried forward).|Day 8|ITT analysis set||percentage of participants|||Number
638676|NCT02432040|Secondary|Adverse Events||6 months|||participants|||Number
638677|NCT02432040|Secondary|Mean Change in hsCRP Levels||6 months|Intention-to-treat analysis was done. Patients who completed the study were included since they were the only ones who had another hsCRP reading after baseline.||nmol/L||Standard Deviation|Mean
638678|NCT02432040|Secondary|Mean Change in Lipid Profile Levels||6 months|Intention-to-treat analysis was done. Patients who completed the study were included.||mg/dL||Standard Deviation|Mean
638679|NCT02432040|Secondary|Mean Change in Dermatology Life Quality Index (DLQI) Scores After 6 Months||6 months|The number of patients analyzed were the ones who completed the study. Intention-to-treat analysis was done.||units on a scale||Standard Deviation|Mean
638680|NCT02432040|Secondary|Percentage of Patients Achieving PASI-50 at the End of 3 Months|PASI-50 means at least a 50% reduction from baseline PASI score|3 months|Intention-to-treat analysis was done. Patients with a baseline score and who had at least one reading after baseline were included.||percentage of participants|||Number
638681|NCT02432040|Secondary|Monthly Mean Changes in PASI Scores|PASI scores were measured monthly and mean changes from baseline for each month for the whole 6-month duration of the study recorded.|Monthly from baseline to 6 months|Intention-to-treat analysis was done. Patients with a baseline score and who had at least one reading after baseline were included.||units on a scale||Standard Deviation|Mean
638682|NCT02432040|Primary|Percentage of Patients Achieving PASI-50 in Each Arm at the End of 6 Months|Percentage of patients in each arm who will achieve 50% reduction in PASI scores at the end of 6 months will be compared|6 months|Intention-to-treat analysis was done. Patients with a baseline score and who had at least one reading after baseline were included.||percentage of participants|||Number
638683|NCT02432040|Primary|Mean Gross Change in Psoriasis Area and Severity Index (PASI) Scores From Baseline to the End of 6 Months|Psoriasis Area and Severity Index involves grading psoriatic plaques based on erythema (E), infiltration (I), desquamation (D). Severity is graded from 0-4 for each criteria (0 – none, 1 – slight, 2 – moderate, 3 – severe, and 4 – very severe). The body is divided into 4 regions, head, upper extremities, trunk, and lower extremities, and for each region, the surface area involvement is graded on a 0-6 scale (0 – 0% involvement, 1 - <10%, 2 – 10-<30%, 3 – 30-<50%, 4 – 50-<70%, 5 – 70-<90%, 6 – 90-100%).The highest potential PASI score is 72, with higher PASI scores indicating worse psoriasis.|6 months|Intention-to-treat analysis was done. Patients with a baseline score and who had at least one reading after baseline were included.||units on a scale||Standard Deviation|Mean
638684|NCT02431754|Secondary|Percentage of Participants With PGI-I (Drug Attributes Questionnaire) on 8 Symptoms for BPH-Lower Urinary Tract Symptoms Improvement|PGI-I (Drug Attributes Questionnaire [DRAQ]) on 8 Symptoms for BPH-Lower Urinary Tract Symptoms.The DRAQ includes the following urinary symptoms: 1. Difficulty to void; 2. Frequent nighttime voiding; 3. Feeling of incomplete emptying; 4. Frequent daytime voiding; 5. Urinary urgency; 6. Taking a long time to urinate; 7. Need abdominal pressure to void; 8. Dribbling, leakage, and/or accidents. Each urinary symptom in the DRAQ will be evaluated by a participant using the PGI-I (discrete variables with seven categories) at the end of each treatment period, compared with how the symptom was before the participant's began taking medication in this study. The percentage of participants who reported a PGI-I (Drug Attributes Questionnaire) score of 1 to 3 are presented in the table below.|Week 8|All randomized participants who received at least one dose of study drug and had a baseline and post baseline PGI-I (DRAQ) measurement.||percentage of participants|||Number
638713|NCT02430870|Secondary|AUC∞: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for TAK-648 for Part 2||Days 1 and 10 pre-dose and multiple time-points post-dose (Up to 72 hours)|The PK Set included all participants in the safety set with at least 1 measurable plasma concentration.||ng*hr/mL||Standard Deviation|Mean
638745|NCT02429258|Secondary|Change in Percentage of CGM Readings Over 24-hours With Plasma Glucose Between 70 mg/dL and 180 mg/dL From Baseline to Week 4 – ITT Population||Baseline to Week 4|||Change in percentage||Standard Error|Least Squares Mean
638686|NCT02431754|Secondary|Change From Baseline on the IPSS Quality of Life Score (IPSS QoL )|"IPSS QoL assess participant response to the following question: If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?. Response options are Delighted (0), Pleased (1); Mostly satisfied (2); mixed about equally satisfied and dissatisfied (3); Mostly dissatisfied (4); Unhappy (5); Terrible (6), with a total ranging from 0 to 6 with higher numerical score representing worse Quality of Life from BPH symptom."|Baseline, Week 8|All randomized participants who received at least one dose of study drug and had a baseline and post baseline IPSS measurement.||units on a scale||Standard Deviation|Mean
638687|NCT02431754|Secondary|Change From Baseline on the IPSS Voiding (Obstructive) Subscore|IPSS voiding (obstructive) subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores ranged from 0 (no obstructive symptoms) to 5 (frequent obstructive symptoms), with total subscore of the 4 questions of the obstructive score ranging from 0 to 20. Higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.|Baseline, Week 8|All randomized participants who received at least one dose of study drug and had a baseline and post baseline IPSS measurement.||units on a scale||Standard Deviation|Mean
638688|NCT02431754|Secondary|Change From Baseline on the IPSS Storage (Irritative) Subscore|IPSS Storage (Irritative) subscore was the sum of Questions 2, 4 and 7 of the IPSS questionnaire. Scores ranged from 0 (no irritative symptoms) to 5 (frequent irritative symptoms), with total subscore of the 3 questions for irritative subscore ranging from 0 to 15. Higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.|Baseline,Week 8|All randomized participants who received at least one dose of study drug and had a baseline and post baseline IPSS measurement.||units on a scale||Standard Deviation|Mean
638689|NCT02431754|Secondary|Change From Baseline on the International Prostate Symptom Score (IPSS) Total Score|IPSS Total Score is the sum of Questions 1 through 7 of the IPSS questionnaire. Each question was scored from 0 (none/no symptoms) to 5 (frequent symptoms) for an IPSS Total Score ranging from 0 to 35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.|Baseline, Week 8|All randomized participants who received at least one dose of study drug and had a baseline and post baseline IPSS measurement.||units on a scale||Standard Deviation|Mean
638690|NCT02431754|Primary|Percentage of Participants Preferring Combination Therapy Over Alpha Blocker Alone on the Treatment Preference Questionnaire (TPQ)|TPQ was used to investigate participant's preference between alpha1 blocker monotherapy and combination therapy with alpha1 blocker plus tadalafil. At the end of Treatment Period 2 (or discontinuation), participants were asked to choose a preferred treatment between the two treatments given in Treatment Period 1 and Treatment Period 2.|Week 20|All randomized participants who received at least one dose of study drug and completed the TPQ.||percentage of participants|||Number
638691|NCT02431741|Primary|Infection in the Wound (Signs of Clinical Infection)|Weekly Visual inspection of the wounds by the investigators.|weekly, for 5 weeks|ITT population||participants|||Number
638692|NCT02431598|Secondary|Severity of Motion Artifacts at Arterial Phase Imaging, Measured on a 1-5 Scale|"no motion artifact
minimal motion artifact
moderate motion artifact
severe motion artifact
extensive motion artifact"|following contrast administration, up to 5 minutes|||scores on a scale||Full Range|Mean
638693|NCT02431598|Secondary|Percentage of Participants With Transient Severe Motion (TSM) Based on Presence of Motion Artifacts at Arterial Phase Imaging|Arterial-phase breath-holding duration and motion artifacts after each agent were compared using the Mann-Whitney-U test and the McNemar test.|following contrast administration, up to 5 minutes|||percentage of participants with TSM|||Number
638694|NCT02431598|Secondary|Heart Rate Following Contrast Injection|Heart rate following contrast injection|following contrast administration, up to 5 minutes|||beats per minute||Standard Deviation|Mean
638695|NCT02431598|Secondary|O2 Saturation Following Contrast Administration||following contrast administration, up to 5 minutes|||percentage||Standard Deviation|Mean
638696|NCT02431598|Primary|Subject-reported Dyspnea, as Measured by Questionnaire Responses|After each breath-hold, the MRI technologist asked the volunteer through the scanner microphone the following two questions, with responses based on a 5-point scale: A) How difficult was it to hold your breath? (1-Not at all; 5-Very difficult); B) Do you feel short of breath now? (1-Not at all; 5-Very short of breath). Responses were recorded for each breath-hold.|following contrast administration, up to 5 minutes|||units on a scale (1-5)||Standard Deviation|Mean
638697|NCT02431598|Primary|Subject Breath Hold Capacity, as Measured by Number of Seconds a Subject Can Hold His/Her Breath||following contrast administration, up to 5 minutes|All participants received all three drugs.||seconds||Full Range|Median
638698|NCT02431455|Secondary|Postoperative Respiratory Complication|atelectasis found on chest imaging, pneumonia, or re intubation|entire inpatient say, usually 1 to 7 days|||participants|||Number
638699|NCT02431455|Primary|Hypoxia 24 Hours Postoperative|Number of subjects with pulse oximetry reading of < 92% with subject off of supplemental oxygen for 5 minutes with head of bed at 30°, 24 hours postoperative.|24 hours postoperative|||participants|||Number
638700|NCT02431455|Primary|Hypoxia 12 Hours Postoperative|Number of subjects with pulse oximetry reading of < 92% with subject off of supplemental oxygen for 5 minutes with head of bed at 30°, 12 hours postoperative.|12 hours postoperative|||participants|||Number
638701|NCT02431455|Primary|Hypoxia 6 Hours Postoperative|Number of subjects with pulse oximetry reading of < 92% with subject off of supplemental oxygen for 5 minutes with head of bed at 30°, 6 hours postoperative.|6 hours postoperative|||participants|||Number
638702|NCT02431299|Secondary|Brief COPE Maladaptive Subscale|This is a consumer rated assessment of adaptive coping skills. This is derived from the 28 item, full scale. The scale uses a 1-4 Likert scale, indicating the frequency of using different coping strategies. There are 14 subscales, each calculated by summing 2 items. The range on each subscale is 2 - 8. The 14 subscales are further combined into 2 larger scales - maladaptive and adaptive coping. Maladaptive coping is calculated by averaging the responses from 6 out of the 14 subscales. Higher scores indicate worse outcomes (i.e. higher use of maladaptive coping strategies).|3-Months|Every effort was made to collect post-intervention follow up data for participants. In some instances, participants were unable to provide this information (i.e. hospitalized, unable to attend data collection session, unwilling). As all outcome measures were consumer self-rated, if the consumer was unavailable data is missing for that participant.||units on a scale||Standard Deviation|Mean
638703|NCT02431299|Secondary|UNCOPE Measure|"This meThis measure is a consumer rated substance abuse screener consisting of 6 yes or no questions. A response of yes is assigned a value of 1. The total number of yes responses are summed and a score of greater than 4 indicates likelihood of substance abuse. Higher scores mean worse outcomes for this scale (i.e. the higher the score, the greater the likelihood of substance abuse issues)."|3-Months|Every effort was made to collect post-intervention follow up data for participants. In some instances, participants were unable to provide this information (i.e. hospitalized, unable to attend data collection session, unwilling). As all outcome measures were consumer self-rated, if the consumer was unavailable data is missing for that participant.||units on a scale||Standard Deviation|Mean
638704|NCT02431299|Secondary|Medication Adherence Rating Scale|"This is a consumer rated scale assessing medication adherence. This is a 10 item scale with each question rated as yes or no. A yes is assigned a value of 1. The scale ranges from 0 (no yes responses) to 10 (all yes responses endorsed). The total number of yes responses is totaled to create a summary score. The mean score is calculated based on averaging the summary scores for the entire consumer sample. Higher scores mean better outcomes for medication adherence."|3-Months|Every effort was made to collect post-intervention follow up data for participants. In some instances, participants were unable to provide this information (i.e. hospitalized, unable to attend data collection session, unwilling). As all outcome measures were consumer self-rated, if the consumer was unavailable data is missing for that participant.||units on a scale||Standard Deviation|Mean
638705|NCT02431299|Secondary|Brief COPE Adaptive Subscale|This is a consumer rated assessment of adaptive coping skills. This is derived from the 28 item, full scale. The scale uses a 1-4 Likert scale, indicating the frequency of using different coping strategies. There are 14 subscales, each calculated by summing 2 items. The range on each subscale is 2 - 8. The 14 subscales are further combined into 2 larger scales - maladaptive and adaptive coping. Adaptive coping is calculated by averaging the responses from 8 out of the 14 subscales. Higher scores indicate better outcomes (i.e. higher use of adaptive coping strategies).|3-Months|Every effort was made to collect post-intervention follow up data for participants. In some instances, participants were unable to provide this information (i.e. hospitalized, unable to attend data collection session, unwilling). As all outcome measures were consumer self-rated, if the consumer was unavailable data is missing for that participant.||units on a scale||Standard Deviation|Mean
638706|NCT02431299|Secondary|Adult State Hope Scale|"This is a consumer rated measure that assesses the level of goal related hope a consumer possesses. This version is a 6 item measure, with each item rated on a 4 point scale (range 1-4, with 1 being Definitely False and 4 being Definitely True). A summary score is calculated by summing all 6 items. Higher scores represent better outcomes (i.e. higher goal related hope). These summary scores were then averages to calculate a mean score for our sample."|3-Months|Every effort was made to collect post-intervention follow up data for participants. In some instances, participants were unable to provide this information (i.e. hospitalized, unable to attend data collection session, unwilling). As all outcome measures were consumer self-rated, if the consumer was unavailable data is missing for that participant.||units on a scale||Standard Deviation|Mean
638707|NCT02431299|Secondary|Multidimensional Scale of Perceived Social Support|This scale is a consumer rated assessment of perceived social support systems. There are 12 items each rated on a 7 point Likert scale (ranging from 1-7). A mean score is calculated from all 12 items. Higher scores represent better outcomes (i.e. higher levels of perceived social support).|3-Months|Every effort was made to collect post-intervention follow up data for participants. In some instances, participants were unable to provide this information (i.e. hospitalized, unable to attend data collection session, unwilling). As all outcome measures were consumer self-rated, if the consumer was unavailable data is missing for that participant.||units on a scale||Standard Deviation|Mean
638708|NCT02431299|Secondary|Working Alliance Inventory Short Form|This is a consumer rated scale indicated working alliance between consumer and clinician. The scale has 12 items, rated on a 7 point Likert style scale (ranging from 1-7). The total score provided a mean score of all 12 items. Better working alliance is indicated by a higher score.|3-Months|Every effort was made to collect post-intervention follow up data for participants. In some instances, participants were unable to provide this information (i.e. hospitalized, unable to attend data collection session, unwilling). As all outcome measures were consumer self-rated, if the consumer was unavailable data is missing for that participant.||units on a scale||Standard Deviation|Mean
638709|NCT02431299|Primary|Illness Management and Recovery Treatment Integrity Scale|Clinician competency rating scale was used to assess clinician competence in providing IMR. This data was used to test the theory that IMR competency would impact consumers' ability to engage in illness self management practices as rated by the Illness Management and Recovery Scale. This scale is rated by trained observers, and the scale contains 16 items, rated on a 1 - 5 point scale. A 5 indicates higher competency and fidelity to the IMR treatment model. A mean score is calculated across all 16 items. Higher scores indicate higher clinician competence in providing IMR.|3-Months|||units on a scale||Standard Deviation|Mean
638710|NCT02431299|Primary|Illness Management and Recovery Scale|Post-intervention scores were assessed. This measure is designed to assess consumer-rated illness self management skills. This scale is based on a 15 items, each rated on a 5 point Likert scale, ranging from 1 to 5. Higher numbers of this scale represent better outcomes. A mean score of all 15 items is provided as the primary outcome score for this scale.|3-Months|Every effort was made to collect post-intervention follow up data for participants. In some instances, participants were unable to provide this information (i.e. hospitalized, unable to attend data collection session, unwilling). As all outcome measures were consumer self-rated, if the consumer was unavailable data is missing for that participant.||units on a scale||Standard Deviation|Mean
638711|NCT02430870|Secondary|AUCtau: Area Under the Plasma Concentration-time Curve From Time 0 Over the Dosing Interval for TAK-648 for Part 2||Days 1 and 10 pre-dose and multiple time-points post-dose (Up to 72 hours)|The PK Set included all participants in the safety set with at least 1 measurable plasma concentration.||ng*hr/mL||Standard Deviation|Mean
638712|NCT02430870|Secondary|AUCtau: Area Under the Plasma Concentration-time Curve From Time 0 Over the Dosing Interval for TAK-648 for Part 1||Days 1 and 17 pre-dose and multiple time-points post-dose (Up to 72 hours)|The PK Set included all participants in the safety set with at least 1 measurable plasma concentration.||ng*hr/mL||Standard Deviation|Mean
638746|NCT02429258|Secondary|Change in Percentage of CGM Readings Over 24-hours With Plasma Glucose <70 mg/dL From Baseline to Week 4 – ITT Population||Baseline to Week 4|||Change in percentage||Standard Error|Least Squares Mean
638721|NCT02430870|Primary|Percentage of Participants Who Have Severe Hypoglycemia at Least Once Post-dose During Dosing For Part 2|Severe hypoglycemia was defined as an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.|Up to Day 13|Safety Analysis Set included of all participants who were enrolled and received at least 1 dose of study drug.||percentage of participants|||Number
638722|NCT02430870|Primary|Percentage of Participants Who Have Severe Hypoglycemia at Least Once Post-dose During Dosing For Part 1|Severe hypoglycemia was defined as an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.|Up to Day 20|Safety Analysis Set included of all participants who were enrolled and received at least 1 dose of study drug.||percentage of participants|||Number
638723|NCT02430870|Primary|Percentage of Participants With Markedly Abnormal Vital Sign Values at Least Once Post-dose During Dosing for Part 2|Vital signs included body temperature (oral), sitting blood pressure (after 5 minutes resting), respiration rate and pulse (bpm),|Up to Day 13|Safety Analysis Set included of all participants who were enrolled and received at least 1 dose of study drug.||percentage of participants|||Number
638724|NCT02430870|Primary|Percentage of Participants With Markedly Abnormal Vital Sign Values at Least Once Post-dose During Dosing for Part 1|Vital signs included body temperature (oral), sitting blood pressure (after 5 minutes resting), respiration rate and pulse (bpm).|Up to Day 20|Safety Analysis Set included of all participants who were enrolled and received at least 1 dose of study drug.||percentage of participants|||Number
638725|NCT02430870|Primary|Percentage of Participants With Markedly Abnormal Laboratory Values at Least Once Post-dose During Dosing for Part 2||Up to Day 13|Safety Analysis Set included of all participants who were enrolled and received at least 1 dose of study drug.||percentage of participants|||Number
638726|NCT02430870|Primary|Percentage of Participants With Markedly Abnormal Laboratory Values at Least Once Post-dose During Dosing for Part 1||Up to Day 20|Safety Analysis Set included of all participants who were enrolled and received at least 1 dose of study drug.||percentage of participants|||Number
638727|NCT02430870|Primary|Percentage of Participants Who Have at Least 1 Treatment-Emergent Adverse Event (TEAE) for Part 2|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|Up to Day 26|Safety Analysis Set included of all participants who were enrolled and received at least 1 dose of study drug.||percentage of participants|||Number
638728|NCT02430870|Primary|Percentage of Participants Who Have at Least 1 Treatment-Emergent Adverse Event (TEAE) for Part 1|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|Up to Day 34|Safety Analysis Set included of all participants who were enrolled and received at least 1 dose of study drug.||percentage of participants|||Number
638729|NCT02430532|Secondary|Change From Baseline to Week 108 in Cognitive Function as Measured by the Symbol Digit Modalities Test (SDMT)|The SDMT measures the time to pair abstract geometric symbols with specific numbers. The score is the number of correctly coded items from 0-110 in 90 seconds. A higher score indicates a better outcome.|Baseline, Week 108|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.|||||
638730|NCT02430532|Secondary|Percentage Change From Baseline to Week 108 in Whole Brain Volume|Whole brain volume is measured by magnetic resonance imaging (MRI).|Baseline, Week 108|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.|||||
638731|NCT02430532|Secondary|Change From Baseline to Week 108 in ABILHAND Questionnaire Score|The ABILHAND Questionnaire measures the participant’s perceived difficulty in performing everyday manual activities in the last 3 months. Participants fill in the 56-item questionnaire by estimating their own difficulty or ease in performing each of the 56 activities. Items are summed to generate a total score and transformed to a scale with a range of 0 to 100, where high scores indicate greater impact on manual ability.|Baseline, Week 108|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.|||||
638732|NCT02430532|Secondary|Change From Baseline to 2 Years on the 12-Item Multiple Sclerosis Walking Scale (MSWS-12)|MSWS-12 is a participant self-assessment of walking limitations due to multiple sclerosis (MS) during the past 2 weeks. It contains 12 items that measure the impact of MS on walking. Items are summed to generate a total score and transformed to a scale with a range of 0 to 100, where high scores indicate greater negative impact on walking.|Baseline, 2 years|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.|||||
638733|NCT02430532|Primary|Time to Disability Progression Independent of Relapse|Time to onset of confirmed progression of disability is defined as 1 or more of the following criteria, confirmed at ≥ 6 months after start of treatment and at Week 108 using 1 or more of the following assessments: Expanded Disability Status Scale (EDSS) score increased from Baseline of ≥ 1 point if baseline EDSS ≤ 5.5, or ≥ 0.5 point if Baseline EDSS ≥ 6.0; Timed 25-Foot Walk (T25FW) ≥ 20% increase from Baseline in the time taken for the 25-foot walk; worsening on the 9-Hole Peg Test (9HPT; ≥ 20% increase from Baseline in the time taken for the 9HPT, confirmed in the same hand). The EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. The T25FW is a quantitative mobility and leg function performance test where the participant is timed while walking for 25 feet. The 9HPT is a quantitative test of upper extremity function that measures the time it takes to place 9 pegs into 9 holes and then remove the pegs.|Up to 108 weeks|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.|||||
638734|NCT02430389|Secondary|Number of Patients Requiring Rescue Therapy for Hemodynamic Perturbations||10 minute window after head fixation|||participants|||Number
638735|NCT02430389|Primary|Mean Arterial Blood Pressure After Head Fixation||Ten minute window after head fixation|||mm Hg||Standard Deviation|Mean
638749|NCT02428478|Secondary|Change in Pharyngeal Critical Collapsing Pressure (Pcrit) as a Measure of Upper Airway Collapsibility|Participants were connected to a modified continuous positive airway pressure (CPAP) machine (Pcrit3000, Respironics) which provided a wide range of pressures between 20 and -20 cm H2O in order to modify upper airway pressure. Following a baseline recording period of 5 minutes, the CPAP level was reduced to varying suboptimal pressures. Change in Pcrit was used to determine the collapsibility of the upper airway under both passive and active conditions, and is expressed as Passive Pcrit: ventilation at a nasal pressure of 0 cm H2O when pharyngeal muscles are passive; Active Pcrit: ventilation at a nasal pressure of 0 cm H2O when pharyngeal muscles are active. Improved=more negative Pcrit.|1 night|All participants who were randomized, completed both study nights, and were included in the analysis. 4 participants were excluded: 3 due to intermittent electromyographic amplifier malfunction; and 1 did not sleep on both study nights.||cm H2O||Inter-Quartile Range|Median
638750|NCT02428478|Primary|Genioglossus Activity During Non-rapid Eye Movement (NREM) Sleep Measured as Percent of Wakefulness Activity|Electromyography (EMG) was used to analyze genioglossus (GG) [EMG GG] muscle movement. EMG GG activity was recorded via standard needle electrodes inserted into the genioglossus (tongue) muscle. Activity of EMG GG was measured during wakefulness and sleep as % of maximum activation obtained pushing the tongue against closed teeth during wakefulness (GG%max). Sleep values were then expressed as %wakefulness value for tonic and phasic EMG GG activity. Tonic activity was defined as the lowest EMG GG value during expiration, phasic activity was calculated as the peak value during inspiration minus the tonic value.|1 night|All participants who were randomized, completed both study nights, and were included in the analysis. 4 participants were excluded: 3 due to intermittent electromyographic amplifier malfunction; and 1 did not sleep on both study nights.||percent wakefulness||Inter-Quartile Range|Median
638751|NCT02428413|Primary|Efficacy of the ISO-Gard Mask in Reducing Caregiver's Exposure to WAG-Duration|For MAX-WAG measurements obtained every 30 seconds, we calculated the duration of MAX-WAG [>2ppm]|1 hour post-operative recovery period|||minutes||Inter-Quartile Range|Median
638752|NCT02428413|Primary|Efficacy of the ISO-Gard Mask in Reducing Caregiver's Exposure to WAG-Percentage of Time|For MAX-WAG measurements obtained every 30 seconds, we calculated the percentage of time in MAX-WAG [>2ppm] relative to the total collection period.|1 hour post-operative recovery period|||percentage of time||Inter-Quartile Range|Median
638753|NCT02428413|Primary|Waste Anesthetic Gas Measured by Parts Per Million Emanating From Patients During Normal PACU Working Conditions|The measurement of Waste Anesthetic Gas in parts per million emanating from the patient between the standard oxygen mask and the ISO-Gard oxygen mask.|1 hour post-operative recovery period|||parts per million||Standard Deviation|Mean
638754|NCT02428413|Primary|Waste Anesthetic Gas Measured by Parts Per Million Within PACU Caregiver's Breathing Zone With Caring for Patients|The measurement of Waste Anesthetic Gas in parts per million resolution emanating from the patient to the caregiver's breathing zone.|1 hour post-operative recovery period|A study size of 100 randomized subjects will be used. Aforementioned sample size was determined to be able to detect an effect size of 0.57 that would provide 80% power and 5% type I error (95% confidence interval and p-0.05 level of significance). Two sample student t-test will be used to do data analysis.||parts per million||Standard Deviation|Mean
638755|NCT02428231|Secondary|Average Change From Baseline in GSRS Scores to the End of Weeks 4, 6, 8, 10, 12, and 14|Average change from baseline to end of DMF treatment in the GSRS. The GSRS is a weekly recall scale to rate the severity of GI symptoms in participants. It was modified for daily recall in this study. GSRS is a rating scale consisting of 15 items for assessment of GI symptoms (see Appendix 1). Items are scored for intensity on a 7-grade Likert scale, defined by descriptive anchors such that 0 = none, 1 = minor, 2 = mild, 3 =moderate, 4 = moderately severe, 5 = severe, and 6 = very severe discomfort. The overall GSRS score is the mean of these 15 items, varying from 0 to 6; a score of 0 indicates that no symptoms are present, and a score of 6 indicates the worst possible degree of all symptoms.|Week 2 (Baseline), Weeks 4, 6, 8, 10, 12, 14|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.|||||
638756|NCT02428231|Secondary|Time to Recovery to Baseline From Last Occurrence of Worst GSRS Score|The GSRS is a weekly recall scale to rate the severity of GI symptoms in participants. The GSRS is a weekly recall scale to rate the severity of GI symptoms in participants. It was modified for daily recall in this study. GSRS is a rating scale consisting of 15 items for assessment of GI symptoms (see Appendix 1). Items are scored for intensity on a 7-grade Likert scale, defined by descriptive anchors such that 0 = none, 1 = minor, 2 = mild, 3 =moderate, 4 = moderately severe, 5 = severe, and 6 = very severe discomfort. The overall GSRS score is the mean of these 15 items, varying from 0 to 6; a score of 0 indicates that no symptoms are present, and a score of 6 indicates the worst possible degree of all symptoms. A higher score relative to Baseline indicates worsening of severity.|Week 2 (Baseline), Week 14|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.|||||
638757|NCT02428231|Secondary|Time to First Worsening From Baseline in GSRS Score|The GSRS is a weekly recall scale to rate the severity of GI symptoms in participants. The GSRS is a weekly recall scale to rate the severity of GI symptoms in participants. It was modified for daily recall in this study. GSRS is a rating scale consisting of 15 items for assessment of GI symptoms (see Appendix 1). Items are scored for intensity on a 7-grade Likert scale, defined by descriptive anchors such that 0 = none, 1 = minor, 2 = mild, 3 =moderate, 4 = moderately severe, 5 = severe, and 6 = very severe discomfort. The overall GSRS score is the mean of these 15 items, varying from 0 to 6; a score of 0 indicates that no symptoms are present, and a score of 6 indicates the worst possible degree of all symptoms. A higher score relative to Baseline indicates worsening of severity.|Week 2 (Baseline), Week 14|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.|||||
638815|NCT02423980|Primary|Number of Subjects With Plasma Glucose > 70 mg/dL at 30 Minutes Post-treatment|For 90 minutes following treatment, plasma glucose was measured every 5 minutes, with an increase in plasma glucose to >70 mg/dL within 30 minutes of treatment being considered a positive response.|0-90 minutes|All treated subjects||participants with positive response|||Number
638816|NCT02423798|Primary|Sensor Survival|sensor survival in hours|4 months|||hours||95% Confidence Interval|Mean
638758|NCT02428231|Secondary|Average Change From Baseline in GSRS Scores During DMF Treatment|Average change from baseline in GSRS scores over the 12 weeks of DMF treatment as measured by the total change in GSRS scores from baseline divided by the total number of days with GSRS scores recorded. The GSRS is a weekly recall scale to rate the severity of GI symptoms in participants. It was modified for daily recall in this study. GSRS is a rating scale consisting of 15 items for assessment of GI symptoms (see Appendix 1). Items are scored for intensity on a 7-grade Likert scale, defined by descriptive anchors such that 0 = none, 1 = minor, 2 = mild, 3 =moderate, 4 = moderately severe, 5 = severe, and 6 = very severe discomfort. The overall GSRS score is the mean of these 15 items, varying from 0 to 6; a score of 0 indicates that no symptoms are present, and a score of 6 indicates the worst possible degree of all symptoms.|Week 2 (Baseline), Week 14|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.|||||
638759|NCT02428231|Primary|Proportion of Participants With a Worsening in Severity of Gastrointestinal (GI) Adverse Events (AEs) on the Gastrointestinal Symptom Rating Scale (GSRS)|The GSRS is a weekly recall scale to rate the severity of GI symptoms in participants. It was modified for daily recall in this study. GSRS is a rating scale consisting of 15 items for assessment of GI symptoms (see Appendix 1). Items are scored for intensity on a 7-grade Likert scale, defined by descriptive anchors such that 0 = none, 1 = minor, 2 = mild, 3 =moderate, 4 = moderately severe, 5 = severe, and 6 = very severe discomfort. The overall GSRS score is the mean of these 15 items, varying from 0 to 6; a score of 0 indicates that no symptoms are present, and a score of 6 indicates the worst possible degree of all symptoms. A higher score relative to Baseline indicates worsening of severity.|from Week 2 (Baseline) to Week 14|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.|||||
638760|NCT02427984|Secondary|Number of Participants Who Scored Positive for ALVAL|"Histological score defined by the valuation of staining It was possible to valuate this outcome only for 29 out of 40 patients MoM (due to the availability of periprosthetic tissues).
The arms CoC and controls were not studied for this issue because ALVAL could occur only in presence of Metals"|3 years|positive for ALVAL is +, negative for ALVAL is -||participants|||Number
638761|NCT02427984|Primary|Amplitude of Articular Noise Produced During Level Walking|Measured by fast Fourier transform (FFT) expressed in amplitude (decibel) This outcome is valuable only for CoC arm and MoM arm, because Control arm patients don't wear prosthesis (no noise)|3 years|||decibel||Full Range|Mean
638762|NCT02427984|Primary|Frequency of Articular Noise Produced During Level Walking|Measured by fast Fourier transform (FFT) expressed in frequency (Hz) This outcome is valuable only for CoC arm and MoM arm, because Control arm patients don't wear prosthesis (no noise)|3 years|||Hz||Full Range|Mean
638763|NCT02427984|Primary|Duration of Articular Noise Produced During Level Walking|"Measured by fast Fourier transform (FFT) expressed in duration (milliseconds)
This outcome is valuable only for CoC arm and MoM arm, because Control arm patients don't wear prosthesis (no noise)"|3 years|||milliseconds||Full Range|Mean
638764|NCT02427984|Primary|Number of Participants With Chromium and Cobalt Ion Levels Above 7ug/l|"Measured by Inductively coupled plasma mass spectrometry (ICP-MS), equipped with dynamic cell reaction (ELAN DRC II) and expressed in micrograms/liter.
Will be counted the number of patients with level os metals above 7micrograms/liter
This outcome is valuable only for MoM arm and Control arm (as comparison), because CoC arm patients don't wear device releasing this kind of metals."|3 years|the population was evaluated as number of patients with ions level above 7ug/l (attention limit)||participants above limit|||Number
638765|NCT02427750|Primary|Number of Subjects Reporting Unsolicited AEs After Receiving One Vaccination of TIV.|The number of subjects in both age groups reporting any unsolicited AEs (between Day 1 to 4), serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal (Day 1 to Day 22), after receiving one vaccination of TIV is reported.|Day 1 to Day 22 post vaccination|Analysis was done on the unsolicited safety set population i.e all subjects who have post vaccination unsolicited adverse event data||Number of Subjects|||Number
638766|NCT02427750|Primary|Number of Subjects Reporting Unsolicited AEs After Receiving One Dose of TIV.|The number of subjects in both age groups reporting any unsolicited AEs between Day 1 to Day 4 after receiving one dose of TIV.|Day 1 to Day 4 post vaccination|Analysis was done on the unsolicited safety set population i.e., all subjects who have post vaccination unsolicited adverse event data.||Number of Subjects|||Number
638767|NCT02427750|Primary|Number of Subjects Reporting Local and Systemic Solicited Adverse Events (AEs) After Receiving One Dose of TIV.|The number of adult and elderly subjects reporting solicited local and systemic AEs and other solicited AEs after receiving one dose of TIV are reported.|Day 1 to Day 4 post vaccination (including 30 mins)|Analysis was done on the solicited safety set population i.e. all subjects who have post vaccination solicited local and systemic adverse event data.||Number of Subjects|||Number
638768|NCT02427750|Primary|GMR of Post Vaccination Versus Pre Vaccination HI Antibody Titers, After Receiving One Dose of TIV.|"The antibody responses following one vaccination of TIV were evaluated in terms of GMRs of post vaccination against pre vaccination geometric mean HI titers against each of the three vaccine strains, three weeks after receiving one dose of TIV.
The related European (CHMP) criterion for the assessment of immunogenicity is met if the GMR day 22/day 1 is >2.5 for adults aged 18 to ≤60 years and > 2.0 for subjects aged ≥61 years."|Day 22/Day 1 post vaccination|The analysis was performed on the PP dataset.||Ratio||95% Confidence Interval|Geometric Mean
638769|NCT02427750|Primary|Percentages of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After Receiving One Dose of TIV.|"Immunogenicity was assessed in terms of percentages of subjects in both age groups achieving seroconversion or significant increase in HI antibody titers after receiving one dose of TIV.
Seroconversion is defined as percentage of subjects with a pre vaccination HI titer <10 and a post vaccination titer ≥40. Significant increase is defined as percentage of subjects with a pre vaccination HI titer ≥10 and at least a 4-fold increase in post vaccination HI antibody titers.
The related European (CHMP) criterion for the assessment of immunogenicity is met if >40% for adults aged 18 to ≤60 years and >30% for subjects aged ≥61 years achieve seroconversion or significant increase in post-vaccination HI titers."|Day 22 post vaccination|The analysis was performed on the PP dataset.||Percentages of Subjects||95% Confidence Interval|Number
648258|NCT02107014|Primary|Change in RANTES From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].|||pg/mL||95% Confidence Interval|Median
638770|NCT02427750|Primary|Percentages of Subjects With Haemagglutination Inhibition (HI) Titers ≥40, Against Each of Three Vaccine Strains After Receiving One Dose of TIV.|"Immunogenicity was assessed in terms of percentages of subjects in both age groups with HI titers ≥40, against each of the three vaccine strains, three weeks after receiving one dose of TIV.
The related European (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving HI titers ≥ 40 is >70% for adults aged 18 to ≤60 years and >60% for subjects aged ≥61 years."|Day 1 and Day 22 post vaccination|The analysis was performed on the PP dataset.||Percentages of Subjects||95% Confidence Interval|Number
638771|NCT02427750|Primary|Geometric Mean Ratio (GMR) of Post Vaccination Versus Pre Vaccination Geometric Mean Area (GMAs), After One Dose of TIV.|"The antibody responses were evaluated in terms of GMRs of post vaccination GMAs to pre vaccination GMAs against each of the three vaccine strains, three weeks after receiving one dose of TIV.
The related European (CHMP) criterion for the assessment of immunogenicity is met if the GMR day 22/day 1 is >2.5 for adults aged 18 to ≤60 years and > 2.0 in for subjects aged ≥61 years."|Day 22/ Day1 post vaccination|The analysis was performed on the PP dataset.||Ratio||95% Confidence Interval|Geometric Mean
638772|NCT02427750|Primary|Percentages of Subjects With Seroconversion or Significant Increase in SRH Area, Against Each of Three Vaccine Strains After Receiving One Dose of TIV.|"Immunogenicity was assessed in terms of percentages of subjects in both age groups achieving seroconversion or significant increase by SRH area against each of the three vaccine strains, three weeks after receiving one dose of TIV.
Seroconversion is defined as percentage of subjects with a pre vaccination SRH area ≤ 4mm^2 achieving a post vaccination SRH area ≥ 25mm^2. Significant increase is defined as percentage of subjects with a pre-vaccination SRH area > 4mm^2 achieving at least 50% increase in post vaccination SRH area.
The related European (CHMP) criterion for the assessment of immunogenicity is met if >40% for adults aged 18 to ≤60 years and >30% for subjects aged ≥61 years achieve seroconversion or significant increase in post-vaccination SRH areas."|Day 22 post vaccination|The analysis was performed on the PP dataset||Percentages of subjects||95% Confidence Interval|Number
638773|NCT02427750|Primary|Percentages of Subjects With Single Radial Hemolysis (SRH) Areas ≥25mm^2, Against Each of Three Vaccine Strains After Receiving One Dose of TIV.|"Immunogenicity was assessed in terms of percentages of subjects in both age groups with SRH areas ≥25mm^2 against each of the three vaccine strains, three weeks after receiving one dose of TIV.
The related European Committee for Medicinal Products for Human Use (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving post vaccination SRH areas ≥ 25mm^2 is >70% for adults aged 18 to ≤60 years and >60% for subjects aged ≥61 years."|Day 1 and Day 22 post vaccination|The analysis was performed on the per-protocol population (PP).||Percentages of subjects||95% Confidence Interval|Number
638774|NCT02427477|Primary|Subjective Overall Vision|Subjective Overall Vision was evaluated using the Contact Lens User Experience Vison scores (CLUE). CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.|1-week Follow-up|The Analysis population includes subjects that completed all study visits without a major protocol deviation. Due to the study design the number of observations analyzed is larger than the number of participants. This is due to the fact that some subjects wore senofilcon A twice while some subjects wore delefilcon A twice (see Participant Flow).||units on a scale|Participants|Standard Deviation|Mean
638775|NCT02427477|Primary|Subjective Overall Comfort|Subjective Overall Comfort was evaluated using the Contact Lens User Experience Comfort scores (CLUE). CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.|1-week Follow-up|The Analysis population includes subjects that completed all study visits without a major protocol deviation. Due to the study design the number of observations analyzed is larger than the number of participants. This is due to the fact that some subjects wore senofilcon A twice while some subjects wore delefilcon A twice (see Participant Flow).||units on a scale|Participants|Standard Deviation|Mean
638776|NCT02427399|Secondary|Proportion Receiving Pap Test at 12 Months|The outcome will be ascertained for each patient through chart review. The effectiveness of each intervention will be assessed through a comparison of screening rates between each of the four intervention arms (letter, email, phone, letter/email/phone) and the control arm (usual care/opportunistic screening).|12 months|||Participants|||Count of Participants
638777|NCT02427399|Secondary|Proportion Receiving Pap Test at 6 Months|The outcome will be ascertained for each patient through chart review. The effectiveness of each intervention will be assessed through a comparison of screening rates between each of the four intervention arms (letter, email, phone, letter/email/phone) and the control arm (usual care/opportunistic screening).|6 months|||Participants|||Count of Participants
638778|NCT02427399|Primary|Proportion of Patients Who Receive a Pap Test at End of Follow up|The outcome will be ascertained for each patient through chart review. The effectiveness of each intervention will be assessed through a comparison of screening rates between each of the four intervention arms (letter, email, phone, letter/email/phone) and the control arm (usual care/opportunistic screening).|18 months|||Participants|||Count of Participants
638779|NCT02425956|Secondary|Serum Ferritin Based on Blood Draw|The secondary outcome is collection of serum ferritin from hematologic analysis (blood draw analyzed by site central lab).|48 hours post MR scan or 24 hours pre MR scan|Every enrolled subject||mg FE /g dry||Standard Deviation|Mean
638780|NCT02425956|Primary|Per Subject Evaluable DICOM Data Sets From Liver MRI|The primary outcome measure is collection of evaluable (based on physician determination) MR DICOM datasets including valid 1.5 and 3.0T image data, P-file, R2* maps, and raw data for each enrolled subject. The datasets were gathered via three independent MR scans conducted within a three hour time block, with up to ten minutes break in between.|48 hours pre or 24 hours post blood draw|MR DICOM datasets were gathered for each enrolled subject (total of three scans per subject equals one complete dataset)||Participants|||Count of Participants
641285|NCT02314520|Secondary|Number of Participants With a Central Line Associated Blood Stream Infection|A Central access associated infection (CLABSI)|up to 10 weeks|||Participants|||Count of Participants
638781|NCT02425826|Secondary|Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) During the Placebo Controlled Phase|Treatment-Emergent Adverse Events (TEAEs) are defined as any AEs that begin or worsen on or after the start of study drug through 28 days after the last dose of study drug or study treatment discontinuation date, whichever was later. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above.|From first dose of study drug to Week 16|The safety population includes all participants who were randomized and received at least one dose of study drug.||participants|||Number
638782|NCT02425826|Secondary|Number of Participants With Scalp Psoriasis Who Maintained the Scalp Physician’s Global Assessment (ScPGA)Response From Week 16 to Week 52.|The ScPGA will assess scalp involvement, if present at baseline. The 6-point ScPGA scale includes three dimensions (Plaque Thickening, Scaling, and Erythema) and a global assessment with scores range from 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), to 5 (very severe). Analysis of ScPGA is restricted to the participants with scalp involvement at baseline.|Week 16 to Week 52||11/2017||||
638783|NCT02425826|Secondary|Mean Percentage Change From Baseline in the Product of BSA (%) x sPGA at Week 52|"BSA is a measurement of involved skin. The overall BSA affected by psoriasis is estimated based on the palm area of the participant's hand (entire palmar surface or handprint including the fingers), which equates to approximately 1% of total body surface area. The sPGA is a 6-point scale ranging from 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), to 4 (severe), 5 (very severe) incorporating a separate assessment of the severity of the three primary signs of the plaques of all involved areas: erythema, scaling and plaque elevation with an overall sPGA calculated as (E + I + D)/3. Scores for each assessment are rounded to the nearest whole number to result in the final score."|Baseline to Week 52||11/2017||||
638784|NCT02425826|Secondary|Percentage of Participants Who Achieved at Least a 75% Improvement (Response) in the Psoriasis Area and Severity Index (PASI)-75 From Baseline at Week 16|The PASI score is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). PASI scores range from 0 to 72, with higher scores reflecting greater disease severity.|Baseline to Week 16 (end of phase)|The ITT population consisted of all participants who were randomized. Participants with a baseline value and at least one post-baseline value are included. A missing value at Week 16 (end of phase) was imputed by LOCF.||percentage of participants||95% Confidence Interval|Number
638785|NCT02425826|Secondary|Percentage of Participants Who Achieved at Least a 50% Improvement (Response) in the Psoriasis Area and Severity Index (PASI)-50 From Baseline at Week 16.|The PASI score is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). PASI scores range from 0 to 72, with higher scores reflecting greater disease severity.|Baseline to Week 16 (end of phase)|The ITT population consisted of all participants who were randomized. Participants with a baseline value and at least one post-baseline value are included. A missing value at Week 16 (end of phase) was imputed by LOCF.||percentage of participants||95% Confidence Interval|Number
638786|NCT02425826|Secondary|Mean Percentage Change From Baseline in Psoriasis Area Severity Index (PASI) at Week 16|The PASI score is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). PASI scores range from 0 to 72, with higher scores reflecting greater disease severity.|Baseline to Week 16 (end of phase)|The ITT population consisted of all participants who were randomized. Participants with a baseline value and at least one post-baseline value are included. A missing value at Week 16 (end of phase) was imputed by LOCF.||percentage change||Standard Deviation|Mean
638787|NCT02425826|Secondary|Change From Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM) Version II at Week 52|The TSQM version II is an 11-question self-administered instrument to understand a participants satisfaction on the current therapy. The TSQM scale comprises four domains, on which participants evaluate their medication (i.e., effectiveness, side effects, convenience and global satisfaction. TSQM scores range from 0 to 100 for each domain; a higher score indicates higher satisfaction with treatment.|Baseline to week 52||11/2017||||
638788|NCT02425826|Secondary|Mean Change From Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM) Version II at Week 16|The TSQM version II is an 11-question self-administered instrument to understand a participation’s satisfaction with the current therapy. The TSQM scale comprises four domains, on which participants evaluate their medication (i.e., effectiveness, side effects, convenience and global satisfaction. TSQM scores range from 0 to 100 for each domain; a higher score mean indicates higher satisfaction with treatment.|Baseline to Week 16 (end of phase)|The ITT population consisted of all participants who were randomized. Participants with a baseline value and at least one post-baseline value are included. A missing value at Week 16 (end of phase) was imputed LOCF.||units on a scale||Standard Deviation|Mean
638789|NCT02425826|Secondary|Percentage of Participants With Scalp Psoriasis Who Achieved a Clear (0) or Minimal (1) on Scalp Physician’s Global Assessment (ScPGA) Scale at Week 16.|The ScPGA assessed scalp involvement, if present at baseline. The 6-point ScPGA scale includes three dimensions (Plaque Thickening, Scaling, and Erythema) and a global assessment. Scores range from 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), to 5 (very severe). Analysis of ScPGA was restricted to the participants with scalp involvement at baseline.|Baseline to Week 16 (end of phase)|The ITT population with scalp psoriasis who were randomized. Participants with at least one post-baseline value are included. A missing value at Week 16 (end of phase) was imputed by LOCF.||percentage of participants||95% Confidence Interval|Number
638790|NCT02425826|Secondary|Mean Change From Baseline in Pruritus Visual Analog Scale (VAS) at Weeks 1 and 16|The Pruritus VAS assessment was conducted at the baseline visit and each post-baseline visit. The participant was asked to place a vertical stroke on a 100 mm VAS on which the left-hand boundary (0) represents no itch, and the right-hand boundary (100) represents itch as severe as can be imagined. The distance from the mark to the left-hand boundary will be recorded. The Pruritus VAS score ranges from 0 to 100. Higher scores correspond to more severe symptom|Baseline to Weeks 1 and 16 (end of phase)|ITT population consisted of all participants who were randomized. Participants with a baseline value and at least one post-baseline value are included. A missing value at Week 16 (end of phase) was imputed by LOCF.||units on a scale||Standard Deviation|Mean
638791|NCT02425826|Secondary|Percentage of Participants Who Achieved a Clear (0) or Very Mild (1) on Patient Global Assessment (PtGA) Scale at Week 16 From Baseline|The PtGA response rate is defined as the percentage of participants achieving 0 (clear) or 1 (very mild) on the PtGA scale at Week 16. The PtGA is the assessment by the participant of the overall disease severity at the time of evaluation. The PtGA is a 5-point scale ranging from 0 (clear) to 4 (severe).|Baseline to Week 16 (end of phase)|The ITT population consisted of all participants who were randomized. Participants with at least one post-baseline value are included. A missing value at Week 16 (end of phase) was imputed by LOCF.||percentage of participants||95% Confidence Interval|Number
638792|NCT02425826|Secondary|Percentage of Participants Who Achieved a sPGA Score of Clear (0) or Almost Clear (1) at Week 16 From Baseline|The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 6-point scale, ranging from 0 (clear) to 5 (very severe), with an overall sPGA calculated as (E + I + D)/3. Scores for each assessment are averaged and rounded to the nearest whole number to result in the final sPGA score.|Baseline to Week 16 (end of phase)|The ITT population consisted of all participants who were randomized. Participants with and at least one post-baseline value are included. A missing value at Week 16 was imputed by LOCF.||percentage of participants||95% Confidence Interval|Number
638793|NCT02425826|Secondary|Mean Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 16|"DLQI is a simple, compact, and practical questionnaire for use in a dermatology clinical setting to assess limitations related to the impact of skin disease. The instrument contains ten items dealing with the participant's skin. With the exception of Item Number 7, the participant responds on a four-point scale, ranging from Very Much (score 3) to Not at All or Not relevant (score 0). Item Number 7 is a multi-part item, the first part of which ascertains whether the participant's skin prevented them from working or studying (Yes or No, scores 3 or 0 respectively), and if No, then the participant is asked how much of a problem the skin has been at work or study over the past week, with response alternatives being A lot, A little, or Not at all (scores 2, 1, or 0 respectively). The DLQI total score is derived by summing all item scores, which has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best."|Baseline to Week 16 (end of phase)|The ITT population consisted of all participants who were randomized. Participants with a baseline value and at least one post-baseline value are included. A missing value at Week 16 (end of phase) was imputed by LOCF.||units on a scale||Standard Deviation|Mean
638794|NCT02425826|Primary|Mean Percentage Change From Baseline in the Product of BSA (%) and the sPGA Which is Considered as the Total Psoriasis Severity Index at Week 16|"BSA is a measurement of involved skin. The overall BSA affected by psoriasis is estimated based on the palm area of the participant's hand (entire palmar surface or handprint including the fingers), which equates to approximately 1% of total body surface area. The sPGA is a 6-point scale ranging from 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), to 4 (severe), 5 (very severe) incorporating a separate assessment of the severity of the three primary signs of the plaques of all involved areas: erythema, scaling and plaque elevation with an overall sPGA calculated as (E + I + D)/3. Scores for each assessment are rounded to the nearest whole number to result in the final score. The range of BSA*sPGA mean percentage change from baseline to week 16 (end of phase) were -100 to 344.4 and -100 to 100 for the placebo and apremilast groups respectively. Higher scores represented worse outcomes."|Baseline to Week 16 (end of phase)|The Intent-to-Treat (ITT) population consisted of all participants who were randomized. Participants with a baseline value and at least one post-baseline value were included. A missing value at Week 16 was imputed by last observation carried forward. (LOCF).||percentage change||Standard Deviation|Mean
638795|NCT02424591|Secondary|Beck's Depression Inventory|"Beck's Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures attitudes and symptoms of depression. Each sentence has a rating from 0 to 3 and the sentences go from mild to fairly severe descriptions of moods. The numbers are tabulated, the lowest possible score is 0 and the highest is 63.
A score of 1-10 indicates normal ups and downs. 11-16 indicates a mild mood disturbance; 17-20, borderline clinical depression; 21-30, moderate depression; 31-40, severe depression; over 40, extreme depression"|Post-op Day 3|||points||Inter-Quartile Range|Median
638796|NCT02424591|Secondary|Pain Score|"McGill Short Form measures pain in different ways. The first part of the form lists 15 adjectives for pain, for which the answers can be none (0), Mild (1), Moderate (2) and Severe (3). Descriptors 1-11 represent the sensory dimension of pain experience and 12-15 represent the affective dimension. A score of 0 is good, and a score of 45 indicates extreme pain. The lower the score the less pain a subject feels (better), as the scores go up, so do the pain levels (worse).
PPI (Present Pain Intensity) asks patients to measure pain from 0 (no pain) to 5 (excruciating). Again, a lower score is ideal."|Post-op Day 3|||points||Inter-Quartile Range|Median
638797|NCT02424591|Primary|Scores on Questionnaires|Quality of Recovery 15 questions questionnaires that ask, on a scale of 0-10, with 0 always being bad and 10 always being best, how the patient is recovering. The total number is reviewed, so the highest total score possible is 150 and the lowest is 0.|Post-op Day 3|||points||Inter-Quartile Range|Median
638798|NCT02424578|Secondary|Safety of Diclofenac Capsules Low Dose and High Dose as Assessed by the Incidence of Adverse Events From Baseline to Day 3 or Early Termination||Baseline to Day 3/Early Termination||||||
638799|NCT02424578|Primary|Plasma Concentration of Diclofenac|The estimated typical value for clearance (tvCl) following a single diclofenac dose based on population pharmacokinetic (PopPK) modeling using sparse plasma concentration data in pediatric subjects.|0-6 hours after first dose of diclofenac|Pharmacokinetic (PK) population. Defined as all subjects who received at least one dose of study drug and had at least one quantifiable plasma diclofenac concentration after dosing.||mL/hr||Standard Error|Mean
638800|NCT02424565|Primary|Time to Significant Increase in Local Surface Temperature|Local surface temperature was measured by the spectral order of colour after application of product. Infra-red camera was used to take 11 images with one just before application of product and remaining 10 images at every minute for first 10 minutes after application of product. IR camera converted the IR energy radiated by the body into electrical impulses, which were then digitally indicated on a spatial temperature map. IR camera represents the temperature distribution in a so-called rainbow or spectral order of colors. The predominant colour will be determined on a 5 point scale based on Thermal Images produced using Infra-Red Thermography (IRT) technique and recorded as either Blue, Green, Yellow, Orange or Deep Orange/Red (In increasing order of temperature). There was an approximate temperature difference of 0.5°C between adjacent colours on the map which was supposed to brought about by application of the product and considered significant.|Every minute from baseline to 10 minutes|Intent-to-treat (ITT) population included all participants of safety population with any post-treatment assessment. Since no significant increase in surface temperature was observed in subjects for either treatment, therefore, number of subjects analyzed for this outcome is zero.|||||
638801|NCT02424149|Secondary|Trial of Void Results|Number of subjects that failed a back-filled trial of void on the day of hospital discharge, up to 2 days after surgery.|Day of hospital discharge|For this outcome, 96 participants were analyzed. Of the 104 participants that completed the study, only 96 underwent a trial of void.||participants who failed trial of void|||Number
638802|NCT02424149|Secondary|Post-operative Urethral Discomfort Measured by Pain Scales|Measured prior to catheter removal using a 10 point visual analog pain scale: Zero represented no pain, Ten represented the most severe pain.|post operative day 1|||units on a scale||Standard Deviation|Mean
638803|NCT02424149|Secondary|Additional Interventions: Measured by Use of IV Fluids, IV Lasix, IV Methylene Blue, or Ureteral Stent Placement in OR|this is a composite measure and will be reported as a single value for each arm as number of additional interventions|day of surgery (day 0)|||interventions|||Number
638804|NCT02424149|Secondary|Physician Confidence Measured by a Survey|"Surgeon response to the question: I am confident that ureteral injury was ruled out in this patient on a 5-point Likert scale where 1 = strongly disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, 5 = strongly agree"|day of surgery (day 0)|||units on a scale||Standard Deviation|Mean
638805|NCT02424149|Primary|Time to Visualize Ureteral Urine Flow Intraoperatively Measured by Timing in the Operating Room|Timing was performed in the operating room. Time to visualize urine efflux was started at insertion of the cystoscope into the bladder, the time was considered complete when both ureteral orifices had displayed urine efflux.|Day of surgery|||seconds||Standard Deviation|Mean
638806|NCT02423993|Secondary|Quality of Life (SF36 Questionnaire)|"We assessed QoL changes during the study and differences of these changes between groups.
SF-36 questionnaire enabling evaluation of patient’s satisfaction with his health status and certain emotional characteristics. 36 items of the Questionnaire are grouped in 8 scales. Each scale ranges from 0 to 100, the latter representing full health."|4 months after CSII initiation|Patients from structured education group completed the QoL Questionnaires prior to education and 4 months after transferring to CSII. Patients from the control group completed (standart education) the Questionnaires during the enrollment.||units on a scale||Inter-Quartile Range|Median
638807|NCT02423993|Secondary|Treatment Compliance ( Frequency of SMBG and Bolus Calculator Use)|Treatment compliance evaluation was based on frequency of SMBG and bolus calculator use as one of the factors mediating achievement of target plasma glucose level.|within 4 month of the study|||events||Standard Deviation|Mean
638808|NCT02423993|Secondary|Glycaemic Variability|"Several glucose variability scores was assessed: SD, MAGE, MODD, LI, HBGI, LBGI, MAG. For SAP users glucose variability scores were calculated from CGM data. For CSII users with SMBG only glucose variability scores were calculated from bolus calculator (Bolus Wizard) data."|within 4 month of the study||11/2015||||
638809|NCT02423993|Secondary|Nonsevere Hypoglycaemia Frequency|Nonsevere hypoglycemia is defined аs an episode of a blood glucose value of less than 70 mg per deciliter (3.9 mmol per liter). All hypoglycaemia episodes was reported in patients dairies and then will be assessed and compared between groups.|within 4 month of the study|||events per day||Standard Deviation|Mean
638810|NCT02423993|Secondary|Quality of Life (ADDQoL Questionnaire)|"Will be assessed QoL changes during the study and differences of these changes between groups.
ADDQoL Questionnaire includes 2 general scales and 18 specific scales. 2 general scales represent the general QoL and diabetes – dependent QoL (scales varies from -3 (worse) to +3 (better)). 18 specific scales represent the impact of diabetes on certain QoL parameters: working life, family life, social life, sex life, physical appearance, do physically, leisure, travel, confidence in ability, motivation, society reaction, future, finances, dependence, living conditions, freedom to eat, other’s , freedom to drink. All scales varies from -9 (worse) to +9 (better)."|4 month after CSII initiation|Patients from structured education group completed the QoL Questionnaires prior to education and 4 months after transferring to CSII. Patients from the control group completed (standart education) the Questionnaires during the enrollment.||units on a scale||Standard Deviation|Mean
638811|NCT02423993|Secondary|Severe Hypoglycaemia Frequency|Severe hypoglycemia is defined аs an episode requiring assistance and will be confirmed by documentation of a blood glucose value of less than 50 mg per deciliter (2.8 mmol per liter) or recovery with restoration of plasma glucose.|within 4 month of the study|||events per month||Standard Deviation|Mean
638812|NCT02423993|Primary|HbA1c|HbA1c was determined by ion exchange chromatography on an automatic biochemical analyzer Bio-RAD D-10 (France), under the manufacturer's standard procedure.|4 month after CSII initiation|"The analysis was per protocol. Patients from group education groups were on MDI regymen and from standart education group were on insulin pump therapy during previously 4 months"||percentage||Inter-Quartile Range|Median
638813|NCT02423980|Secondary|Time to Resolution of Induced Hypoglycemia Symptoms|Prior to and every 5 minutes after treatment, subjects were asked to rate the severity of each of 8 symptoms on a scale from 1 to 6, with 1 indicating the symptom was absent and 6 indicating the symptom was severe. The sum of the scores for the 8 individual symptoms was reported as the total hypoglycemia symptom score, which ranged from 8-48. The first time point post-treatment at which total hypoglycemia symptom score = 8 (i.e., all symptoms were absent) was considered the time to resolution. One and two subjects were unevaluable for response to the 1 mg and 0.5 mg doses of glucagon, respectively, as they reported no symptoms (i.e., total symptom score = 8) prior to treatment.|0-30 minutes|Subjects with symptoms of hypoglycemia at time of treatment||minutes||Full Range|Median
638818|NCT02423798|Primary|Sensor Accuracy|Sensor values were compared to YSI plasma glucose values, which is considered as the gold standard, during the frequent sample testing day (day 3). MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100).|4 months|||percentage||Standard Deviation|Mean
638819|NCT02423577|Primary|Frequencies of Viral Shedding|Percentage of Subjects Demonstrating Viral Shedding.|Day 2 to Day 10|The percentage of subjects demonstrating viral shedding was estimated for each treatment with corresponding asymptotic 95% confidence intervals, based on the normal approximation to the binomial distribution (Wilsons’s method)||Participants|||Count of Participants
638820|NCT02423447|Primary|Pulmonary Function Measured as a Percent Predicted AFTER Therapy With Either ElectroFlo 5000 / G5.|Comparison of pulmonary function by doing spirometry testing on study patients during their Day 1 & Day 2 therapy sessions. Will also compare the results based on the therapies they receive.|End of study visit per intervention|||percentage of predicted value||Full Range|Mean
638821|NCT02423447|Primary|Dry Sputum Weight|To compare the wet to dry weight of study patients' sputum collected during their Day 1 & Day 2 therapy sessions.|End of study visit per intervention|||gram||Full Range|Mean
638822|NCT02423447|Secondary|PRO (Patient-reported Outcome)|Investigators will question the study patients re: their tolerability and comfort after the intervention on Day 1 & Day 2 visits.|End of study visit per intervention|Patients rated comfort on a scale of 1 (most comfortable) to 10 (most un-comfortable)||units on a scale||Full Range|Mean
638823|NCT02423447|Secondary|Pulmonary Function Measured as a Percent Predicted BEFORE Therapy With Either ElectroFlo 5000 / G5.|Comparison of pulmonary function by doing spirometry testing on study patients during their Day 1 & Day 2 therapy sessions. Will also compare the results based on the therapies they receive.|End of study visit per intervention|||percentage of predicted value||Full Range|Mean
638824|NCT02423447|Primary|Wet Sputum Weight|To compare the wet to dry weight of study patients' sputum collected during their Day 1 & Day 2 therapy sessions.|End of study visit per intervention|||gram||Full Range|Mean
638825|NCT02423408|Secondary|Number of Subjects With at Least a Two-category Improvement From Baseline at 2 Hours Post-dose in VAS Severity Category (Carvalho Responders)|"The Carvalho Responder analysis refers to subjects with at least 2 categories of improvement in their VAS severity category (0-100 scale). VAS severity categories were defined as severe if between 52-100 inclusive, moderate between 31-51 inclusive, mild between 6-30 inclusive, and pain-free if less than 6. Therefore, a Carvalho responder was either a subject who had a VAS response classified as ‘severe’ at baseline and ‘mild’ or pain-free at the post-dose assessment time point, or a subject who had a VAS response classified as ‘moderate’ at baseline and pain-free at the post-dose assessment time point."|2 hours|"Only subjects who were categorized as severe or moderate at baseline and have data reported at 2 hours were included in this analysis. All subjects who took rescue medication at or before 2 hours were considered non-responders."||Participants|||Count of Participants
638826|NCT02423408|Secondary|Number of Subjects Using Rescue Medication During the 24-hour Post-dose Period||24-hour post-dose period|8 subjects in the TNX-201 group and 10 subjects in the placebo group who did not take a dose during the double-blind treatment period and/or did not report data 2-hour post-dose were excluded from analyses.||Participants|||Count of Participants
638827|NCT02423408|Secondary|Number of Subjects Pain Free at 15, 30, 60, 90 Minutes and 4 Hours Post-dose (Pain Will be Assessed by 4-point NRS, VAS, and Binary Yes/no Question)|"4-point NRS grades: 0=none, 1=mild, 2=moderate, 3=severe.
VAS: 0-100 scale, No Pain vs. Worst Imaginable Headache Pain"|15, 30, 60, 90 minutes and 4 hours post-dose|"LOCF Analysis
8 subjects in the TNX-201 group and 10 subjects in the placebo group who did not take a dose during the double-blind treatment period and/or did not report data 2-hour post-dose were excluded from analyses."||Participants|||Count of Participants
638828|NCT02423408|Primary|Number of Subjects Pain Free|"Number of subjects pain free at 2 hours post-dose (Pain assessed by 4-point NRS, VAS, and binary yes/no question).
4-point NRS grades: 0=none, 1=mild, 2=moderate, 3=severe; pain-free defined as score = 0.
VAS: 0-100 scale, anchored by verbal anchors of No Pain (0) vs. Worst Imaginable Headache Pain (100). Pain-free was defined as a score <= 5"|2 hours|"LOCF Analysis
8 subjects in the TNX-201 group and 10 subjects in the placebo group who did not take a dose during the double-blind treatment period and/or did not report data 2-hour post-dose were excluded from analyses."||Participants|||Count of Participants
638829|NCT02423317|Secondary|Number of Participants With Airway Trauma|Airway trauma was defined as blood detected on the blades of laryngoscopes, blood on endotracheal tube after extubation or tongue-lip-dental trauma.|5 minutes|||participants|||Number
638830|NCT02423317|Secondary|Number of Esophageal Intubation.|Insertion of tracheal tube inside the esophagus|5 minutes|||esophageal intubation|||Number
638831|NCT02423317|Secondary|Overall Intubation Success Rate.|It is the number of participants who were successfully intubated after first, second or third attempts. Success of intubation is defined as placement of endotracheal tube inside the trachea, confirmed by bilateral chest auscultation and square wave capnograph tracing.|5 minutes|||participants|||Number
638832|NCT02423317|Secondary|Percentage of Glottic Opening Scoring.|The Percentage of glottic opening score represents the percentage of glottic opening seen, defined by the linear span from the anterior commissure to the interarytenoid notch|5 minutes|||percentage of glottic opening||Inter-Quartile Range|Median
638833|NCT02423317|Secondary|Ease of Intubation.|The intubating anaesthesiologist graded the ease of intubation for both techniques on a visual analogue scale from 1 to 10, 10 being most difficult or failed intubation and 1 being very easy intubation.|5 minutes|||scores on visual analogue scale||Inter-Quartile Range|Median
638834|NCT02423317|Secondary|Number of Intubation in First Attempts;|A single insertion of the Airtraq or a single insertion of the Miller laryngoscope blade into the mouth with passing the endotracheal tube beyond the glottis was considered as an attempt.|5 minutes|||Intubations|||Number
638835|NCT02423317|Primary|Time to Intubation|It is defined as the time from placement of Airtraq or Miller laryngoscope into the mouth till appearance of the capnograph waveform|5 minutes|||seconds||Standard Deviation|Mean
638865|NCT02420951|Secondary|Swelling Measured Using a Perometer|Swelling in the operative leg will be measured using a perometer which calculates the total volume of the extremity in cubic centimeters (Pero-System, Wuppertal, Germany).|7 days|This data was not recorded.|||||
641659|NCT02299869|Primary|Comfort Preference|Participant's subjective preference for comfort on a 3 point Likert Scale. 1=prefer CVI-test lens, 2=prefer Competitor-control lens, 3=no preference|Baseline|||participants|||Number
638836|NCT02423291|Primary|Overall Objective Response Rate in Patients With Relapsed or Refractory PMLBCL|"The antitumor efficacy of single-agent Brentuximab vedotin (1.8 mg/kg administered intravenously every 3 weeks) as measured by the overall objective response rate in patients with relapsed or refractory primary mediastinal large B-cell lymphoma was determined using Cheson BD, Pfistner B, Juweid ME, et al. Revised response criteria for malignant lymphoma. J Clin Oncol. 2007 Feb 10;25(5):579-586.Treatment response was assessed by dedicated spiral CT scan of neck, chest, neck, abdomen, and pelvis and PET scans performed at protocol-specified time points. Clinical response of progressive disease (PD), stable disease (SD), partial remission (PR), or complete remission (CR) will be determined at each assessment."|42 months|Trial was closed due to drug inefficacy on 14/Jul/2016 (last enrollment on 30/Jun/2015). Details in the Outcome Measure Data Table.||Participants|||Count of Participants
638837|NCT02421211|Secondary|Number of Participants Not Achieving Sustained Virologic Response (SVR) Showing Emerging Mutation in HCV Nonstructural Protein 3/4A (NS3/4A), Nonstructural Protein 5A (NS5A), and Nonstructural Protein 5B (NS5B) Sequence||Up to end of follow-up phase (Week 12 of follow-up phase) in Panel 1 and Panel 2|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF. Since the data was to be analysed in the participants who did not achieve SVR, but all the participants achieved SVR in the study. Therefore the data was not collected for this outcome measure.|||||
638838|NCT02421211|Secondary|Percentage of Participants With Viral Relapse|Participants who did not achieve SVR12, with undetectable HCV RNA at the actual end of study drug treatment and confirmed HCV RNA greater than or equal to (>=) LLOQ during follow-up.|Up to Week 12 follow-up phase after EOT|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF.||percentage of participants|||Number
638839|NCT02421211|Secondary|Percentage of Participants With On-treatment Failure|On-treatment failure is defined as participants who did not achieve SVR12 and with confirmed detectable HCV RNA at the actual end of treatment. This was to include participants with: 1) Viral breakthrough, defined as a confirmed increase of greater than (>)1 log10 in HCV RNA from nadir, or confirmed HCV RNA of >100 IU/mL in participants whose HCV RNA had previously been <LLOQ while on treatment; 2) Other with confirmed detectable HCV RNA at the actual end of treatment (example, completed, discontinued due to AEs, withdrawal of consent).|Day 70 in Panel 1 and Day 56 in Panel 2|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF.||percentage of participants|||Number
638840|NCT02421211|Secondary|Percentage of Participants With Sustained Virologic Response (SVR) 4 Weeks After the Actual EOT (SVR4) and 12 Weeks After the Actual EOT (SVR12)|SVR4 or SVR12 is defined as sustained virologic response 4 or 12 weeks after the actual EOT the participant has HCV RNA <LLOQ detectable or undetectable.|4 weeks after EOT (Week 4 of follow-up phase in Panel 1 and Panel 2) and 12 weeks after EOT (Week 12 of follow-up phase in Panel 1 and Panel 2)|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF.||percentage of participants|||Number
638841|NCT02421211|Secondary|Percentage of Participants With On-treatment Virologic Response|"On-treatment virologic response was determined by hepatitis C virus (HCV) ribonucleic acid (RNA) results satisfying a specified threshold.
The following thresholds were considered at any time point: less than (<) lower limit of quantification (LLOQ) undetectable, <LLOQ detectable and <LLOQ undetectable/detectable."|Week 1, up to EOT (Week 10 in Panel 1 and Week 8 in Panel 2)|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF.||percentage of participants|||Number
638842|NCT02421211|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Up to 10 Weeks for Panel 1 and 8 Weeks for Panel 2|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF.||number of participants|||Number
638843|NCT02421211|Secondary|Fluctuation Index (FI) of Ledipasvir|Fluctuation index is defined as percentage fluctuation (variation between maximum and minimum concentration at steady state), calculated as: 100*([Cmax Cmin]/Cavg).|Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF. Here, “Number of Participants Analyzed” signifies those participants who were evaluable for this outcome measure.||percentage fluctuation||Standard Deviation|Mean
638844|NCT02421211|Secondary|Average Plasma Concentration at Steady State (Cavg,ss) of Ledipasvir|The Cavg,ss is calculated as area under the plasma concentration-time curve during a dosing Interval (AUC[tau]) divided by the dosing interval (tau).|Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF. Here, “Number of Participants Analyzed” signifies those participants who were evaluable for this outcome measure.||ng/mL||Standard Deviation|Mean
638845|NCT02421211|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Ledipasvir|The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.|Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF. Here, “Number of Participants Analyzed” signifies those participants who were evaluable for this outcome measure.||Hour||Full Range|Median
638846|NCT02421211|Secondary|Trough Plasma Concentration (Ctrough) of Ledipasvir|The (Ctrough) is the plasma concentration before dosing or at the end of the dosing interval of any dose other than the first dose in a multiple dosing regimen.|Pre-dose on Day 14 and Day 28|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF. Here, “Number of Participants Analyzed” signifies those participants who were evaluable for this outcome measure.||ng/mL||Standard Deviation|Mean
638847|NCT02421211|Secondary|Fluctuation Index (FI) of Simeprevir|Fluctuation index is defined as percentage fluctuation (variation between maximum and minimum concentration at steady state), calculated as: 100*([Cmax Cmin]/Cavg).|Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF. Here, “Number of Participants Analyzed” signifies those participants who were evaluable for this outcome measure.||percentage fluctuation||Standard Deviation|Mean
638848|NCT02421211|Secondary|Average Plasma Concentration at Steady State (Cavg,ss) of Simeprevir|The Cavg,ss is calculated as area under the plasma concentration-time curve during a dosing Interval (AUC[tau]) divided by the dosing interval (tau).|Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF. Here, “Number of Participants Analyzed” signifies those participants who were evaluable for this outcome measure.||ng/mL||Standard Deviation|Mean
638849|NCT02421211|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Simeprevir|The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.|Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF. Here, “Number of Participants Analyzed” signifies those participants who were evaluable for this outcome measure.||hour (H)||Full Range|Median
638850|NCT02421211|Secondary|Trough Plasma Concentration (Ctrough) of Simeprevir|The (Ctrough) is the plasma concentration before dosing or at the end of the dosing interval of any dose other than the first dose in a multiple dosing regimen.|Pre-dose on Day 14 and Day 28|The Intent-to-treat (ITT) analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF. Here, “Number of Participants Analyzed” signifies those participants who were evaluable for this outcome measure.||nanogram per Milliliters (ng/mL)||Standard Deviation|Mean
638851|NCT02421211|Primary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Ledipasvir|AUCtau is defined as area under the analyte concentration versus time curve during dosing interval tau, calculated by linear-linear trapezoidal summation.|Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF. Here, “Number of Participants Analyzed” signifies those participants who were evaluable for this outcome measure.||ng*h/mL||Standard Deviation|Mean
638852|NCT02421211|Primary|Maximum Plasma Concentration (Cmax) of Ledipasvir|The Cmax is the maximum observed plasma concentration.|Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF. Here, “Number of Participants Analyzed” signifies those participants who were evaluable for this outcome measure.||ng/mL||Standard Deviation|Mean
638853|NCT02421211|Primary|Minimum Plasma Concentration (Cmin) of Ledipasvir (LDV)|The Cmin is the minimum observed plasma concentration.|Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF. Here, “Number of Participants Analyzed” signifies those participants who were evaluable for this outcome measure.||ng/mL||Standard Deviation|Mean
638854|NCT02421211|Primary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Simeprevir|The AUCtau is the measure of the plasma drug concentration from time zero to end of dosing interval. It is used to characterize drug absorption.|Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF. Here, “Number of Participants Analyzed” signifies those participants who were evaluable for this outcome measure.||nanogram hour per Milliliters (ng*h/mL)||Standard Deviation|Mean
638855|NCT02421211|Primary|Maximum Plasma Concentration (Cmax) of Simeprevir|The Cmax is the maximum observed plasma concentration.|Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF. Here, “Number of Participants Analyzed” signifies those participants who were evaluable for this outcome measure.||ng/mL||Standard Deviation|Mean
638856|NCT02421211|Primary|Minimum Plasma Concentration (Cmin) of Simeprevir (SMV)|The Cmin is the minimum observed plasma concentration.|Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF.||nanogram per Milliliters (ng/mL)||Standard Deviation|Mean
638857|NCT02421120|Secondary|Safety and Tolerability (Changes in Serum Chemistry, Hematology and Hepatic Lab Values, as Well as Reported Adverse Events)|This outcome will assess the safety and tolerability of ceftolozane/tazobactam in adults with CF after 4-6 doses, as measured by changes in serum chemistry, hematology and hepatic lab values, as well as reported adverse events by patients and providers.|3 days||||||
638858|NCT02421120|Secondary|Ceftolozane Probability of Target Attainment at 8 mcg/ml|This simulated outcome indicates the likelihood that ceftolozane will retain drug concentrations above the MIC for >/= 60% of the dosing interval at an MIC of 8 mcg/ml when administered as a 3g (2g ceftolozane/1g tazobactam) every 8 hour dose infused over 1 hour. This analysis is conducted via a Monte Carlo simulation using the population pharmacokinetic parameter estimates and dispersion from the 20 participants who contributed pharmacokinetic data to the study.|24 hours|The results of this analysis are based on 5000 simulated patients with the same pharmacokinetics to the 20 enrolled participants.||percent of simulated population|||Number
638859|NCT02421120|Primary|Tazobactam Volume of Distribution (Central Compartment)|This outcome determines the volume of distribution of tazobactam over the 8 hour dosing interval.|0, 1-1.08, 1.25-1.5, 2-3, 4-5, and 7-8 hours after start of final dose|||Liters||Standard Deviation|Mean
638860|NCT02421120|Primary|Tazobactam Clearance|This outcome determines the clearance of tazobactam over the 8 hour dosing interval.|0, 1-1.08, 1.25-1.5, 2-3, 4-5, and 7-8 hours after start of final dose|||Liters per hour||Standard Deviation|Mean
638861|NCT02421120|Primary|Ceftolozane Volume of Distribution (Central Compartment)|This outcome determines the volume of distribution of ceftolozane over the 8 hour dosing interval.|0, 1-1.08, 1.25-1.5, 2-3, 4-5, and 7-8 hours after start of final dose|||Liters||Standard Deviation|Mean
638862|NCT02421120|Primary|Ceftolozane Clearance|This outcome determines the clearance of ceftolozane over the 8 hour dosing interval.|0, 1-1.08, 1.25-1.5, 2-3, 4-5, and 7-8 hours after start of final dose|||Liters per hour||Standard Deviation|Mean
638863|NCT02420951|Secondary|Quadriceps Strength Measured Using a Biodex Handheld Dynamometer|Quadriceps strength will be measured using a Biodex handheld dynamometer (Shirley, NY) to measure the force exerted by the quadricep in Newtons|8-12 weeks||||||
638864|NCT02420951|Secondary|Proprioception Measured Using a SD Balancer|Proprioception will be measured using a SD Balancer (Biodex Medical Systems, Shirley, NY) which calculates the the overall stability index (OSI) and compares it to age standardized data|8-12 weeks||||||
638866|NCT02420951|Secondary|Pain Med Consumption Assessed Using Questionnaire/Hospital Records|Questionnaire/Hospital Records - While patients are in the hospital, pain medication consumption will be tracked in their electronic medical record. At home, patients will be asked to keep a log of pain medication consumption. They will be asked to record this information on a questionnaire at their first post-operative visit.|2 days|||morphine milligram equivalents (mgs)||Full Range|Mean
638867|NCT02420951|Primary|Pain Assessed Using the VAS 0-10 Pain Scale|Pain will be assessed using the VAS 0-10 pain scale. 0 is no pain and 10 in worst imaginable pain.|7 days|||units on a scale||Full Range|Mean
638868|NCT02420093|Primary|Change in Numeric Pain Rating Scale|"This questionnaire measures subjective perception of pain levels on a 0-10 (11 point) scale, with 0 being no pain and 10 being the worst pain imaginable."|Change from Baseline after 3 Weeks|||units on a scale||Standard Error|Mean
638869|NCT02420093|Primary|Change in Fingertip to Floor Flexibility Test|This test measures subjects flexibility in forward trunk bending while subject is standing on a block 20 cm high. Measurement is in centimeters from fingertip to edge of step, above or below the step edge.|Baseline and 3 Weeks|||centimeters||Standard Error|Mean
638870|NCT02420093|Primary|Change in Sorenson Test for Lumbar Muscle Endurance|This test measures a persons back strength in 1 repetition of holding a back posture in neutral as long as can while lying on their stomach, legs stabilized on a treatment table.|Baseline and 3 Weeks|||time in seconds||Standard Deviation|Mean
638871|NCT02420093|Primary|Change in Left and Right Hamstring Length Testing|This test measures left and right hamstring length of the subject while they are lying on their back. The angle between the femur and tibia/fibula were measured when the hip angle held constant at 90 degrees and knee in full amount of available knee extension. This measure will use inclinometers for measurement.|Baseline and 3 Weeks|||degrees||Standard Error|Mean
638872|NCT02420093|Primary|Change in Modified Oswestry Low Back Pain Disability Index|This questionnaire measures the impact subject's low back pain on functional tolerance levels. Scale range is 0-100 with the lower score indicating a higher functional / activity level as it relates to Low Back Pain.|Baseline and 3 Weeks|||units on a scale||Standard Error|Mean
638873|NCT02420041|Secondary|Satisfaction of Procedure as a Measure of Safety and Tolerability Using a Numerical Scale 1-5|"1= very dissatisfied to 5=very satisfied."|3 months post-procedure|Numbers of participants analyzed are not consistent because study subjects were lost to follow-up along different points in time in the study.||units on a scale of satisfaction||Full Range|Mean
638874|NCT02420041|Secondary|Satisfaction of Procedure as a Measure of Safety and Tolerability Using a Numerical Scale 1-5|"1= very dissatisfied to 5=very satisfied."|2 weeks post-procedure|Numbers of participants analyzed are not consistent because study subjects were lost to follow-up along different points in time in the study.||units on a scale of satisfaction||Full Range|Mean
638875|NCT02420041|Secondary|Change in Pain Score Since SI Injection at 3 Months Post-procedure Using the DoD/VA PRS|Study subjects rate their pain on a scale of 0-10 (0=no pain, 10= the highest level of pain experienced), hence the lower the score the better the outcome.Score reported is reporting a difference/change between two time points.|during/just before sacroiliac (SI) injection and 3 months post-procedure|Numbers of participants analyzed are not consistent because study subjects were lost to follow-up along different points in time in the study.||units on a scale||Full Range|Mean
638876|NCT02420041|Secondary|Change in Pain Score Since Sacroiliac (SI) Injection at 2 Weeks Post-procedure Using the DoD/VA PRS|Study subjects rate their pain on a scale of 0-10 (0=no pain, 10= the highest level of pain experienced), hence the lower the score the better the outcome. Score reported is reporting a difference/change between two time points.|during/just before sacroiliac (SI) injection and 2 weeks post-procedure|Numbers of participants analyzed are not consistent because study subjects were lost to follow-up along different points in time in the study.||units on a scale||Full Range|Mean
638877|NCT02420041|Secondary|Impression of Change of Condition at 3 Months Post-procedure Using the PGIC Scale|Study subjects rate their change in overall condition on a scale of 0-6 (0=no change, 6=better and a definite improvement that has made a real worthwhile difference). The range of the change in pain for both groups observed was in fact 0-5.|3 months post-procedure|Numbers of participants analyzed are not consistent because study subjects were lost to follow-up along different points in time in the study.||units on a scale||Full Range|Mean
638878|NCT02420041|Secondary|Impression of Change of Condition at 2 Weeks Post-procedure Using the Patient Global Impression of Change (PGIC) Scale|Study subjects rate their change in overall condition on a scale of 0-6 (0=no change, 6=better and a definite improvement that has made a real worthwhile difference). The range of the change in pain for both groups observed was in fact 0-5.|2 weeks post-procedure|Numbers of participants analyzed are not consistent because study subjects were lost to follow-up along different points in time in the study.||units on a scale||Full Range|Mean
638879|NCT02420041|Primary|Change in Pain Score From Baseline to 3 Months Post-procedure Using the DoD/VA PRS|Study subjects rate their pain on a scale of 0-10 (0=no pain, 10= the highest level of pain experienced), hence the lower the score the better the outcome.|3 months post-procedure minus baseline|numbers of participants analyzed are not consistent because study subjects were lost to follow-up along different points in time in the study||units on a scale||Full Range|Mean
638880|NCT02420041|Primary|Change in Pain Score From Baseline to 2 Weeks Post-procedure Using the DoD/VA PRS|Study subjects rate their pain on a scale of 0-10 (0=no pain, 10= the highest level of pain experienced), hence the lower the score the better the outcome.|2 weeks post-procedure minus baseline|||units on a scale||Full Range|Mean
638881|NCT02420041|Primary|Change in Pain Score From Baseline to 30 Minutes Pre-procedure Using the Defense and Veterans Pain Rating Scale (DoD/VA PRS) 0-10|Study subjects rate their pain on a scale of 0-10 (0=no pain, 10= the highest level of pain experienced), hence the lower the score the better the outcome.|30 minutes pre-procedure minus baseline|||units on a scale||Full Range|Mean
638882|NCT02420041|Primary|Difference in Minutes Between a Sacroiliac Joint Injection Done With Ultrasound vs Fluoroscopy|during procedure from the time monitors are placed on patient to the time of withdrawal of needle from skin|difference in minutes between a sacroiliac joint injection, an expected average of 9 minutes|||minutes||Full Range|Mean
638892|NCT02419313|Secondary|Patients With Significant Improvement in Unified Parkinsons Disease Rating Tremor Scale|This scale measures the amplitude of the tremor. For instance tremor of more than 4cm oscillation is grade 4. UPDRS tremor scale is 0-4 , 4 being severe tremor. Significant improvement for this protocol considered two grades of improvement .|4 Weeks|||participants|||Number
638893|NCT02419313|Secondary|Number of Patients Whose Patient Global Impression of Change (PGIC) Improved|"The PGIC is a 7 point scale that requires the clinician to assess how much the patient's pain has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as:
No change (or condition has gotten worse) (1) Almost the same, hardly any change at all (2) A little better, but no noticeable change (3) Somewhat better, but the change has not made any real difference (4) Moderately better, and a slight but noticeable change (5) Better and a definite improvement that has made a real and worthwhile difference (6) A great deal better and a considerable improvement that has made all the difference (7)improved
This outcome is number of patients who chose a 6 or above on the PGIC 6 weeks after treatment."|4 weeks|||participants|||Number
638894|NCT02419313|Primary|Unified Parkinsons Disease Rating Scale (UPDRS) Tremor Scale|The primary outcome measure in this protocol is significant improvement of tremor (equal or over 2 grade improvement) of the Unified Parkinson's Disease Rating Scale 4 weeks after Xeomin injection. The score is 0 to 4 , ) being no tremor and 4 severe tremor. The higher the score, the more severe the tremor.|4 weeks|||participants|||Number
638895|NCT02419001|Primary|Ceftriaxone PK Area Under the Concentration-time Curve From Time 0 to the Last Quantifiable Concentration (AUCt) With (Period 2) and Without (Period 1) SYN-004.||2 weeks|||h*ng/mL||Standard Deviation|Mean
638896|NCT02419001|Primary|Ceftriaxone PK Time to Reach Cmax (Tmax) With (Period 2) and Without (Period 1) SYN-004.|Samples were collected at 0.25 h, 0.5 through 2 h, and 3 through 7 h after the infusion start. Standard deviations may be 0 if all collected T max values occur at the same time.|2 weeks|||hours||Standard Deviation|Mean
638897|NCT02419001|Primary|Ceftriaxone PK Maximum Observed Plasma Concentration (Cmax) With (Period 2) and Without (Period 1) SYN-004.||2 weeks|||ng/mL||Standard Deviation|Mean
638898|NCT02418676|Secondary|Blood Glucose Tests in Order to Assess Whether the Gel With Hydroxypropyl-beta-cyclodextrin Complexed With Insulin (HPβCD-I) or With Insulin Could Cause an Increase in the Rate of Insulin in the Blood of Patients|Dosages were provided four times daily (04h, 10h, 16h and 22h) to each patient during the 15-day study period, giving a total of 60 doses. To obtain these dosages, a drop of blood of patients was placed on a colorimetric strip and blood glucose was measured with the use of an Accu Check Active® glucose meter. The mean of 60 dosages was calculated for each patient at the end of 15 days. For each group assessed, it was calculated the mean of the measurements of the five patients, resulting in a single value.|Assessed daily at 04 h, 10 h, 16 h and 22 h for 15 days|Brazilian, bedridden, of both genders, aged between 45 and 75 years old and diabetic or not. Hyperglycemic volunteers and those with pressure ulcers other than grade II were excluded from the study.||mg/dL||95% Confidence Interval|Mean
638899|NCT02418676|Primary|Efficacy Index (%EI)|Every three days the pressure ulcers (PUs) of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos were evaluated for measurement of PUs and any kind of irritation. At the end of this stage, the properly gathered study data was interpreted using the analysis software Mobile Wound Analyzer® (MOWA). Healing efficacy indices (% EI) were calculated as percentage reduction in the wound size at days 3, 6, 9, 12 and 15 from treatment beginning (d0). The % EI of the wound size was calculated by the following equation: %EI= ((Vsp.day-Vi)/Vi))x100. Vsp.day refers to the diameter (mm) values measured at day 3, 6, 9,12 and 15, while Vi refers to the baseline value measured before treatment (d0). The most representative result of treatment efficacy was observed on day 15, therefore it was used to calculate the % EI. For each group assessed, it was calculated the mean % EI of the five patients, resulting in a single value.|Measured every 3 days for 15 days|Brazilian, bedridden, of both genders, aged between 45 and 75 years old and diabetic or not. Hyperglycemic volunteers and those with pressure ulcers other than grade II were excluded from the study. Grade II pressure ulcers were selected as they are a superficial lesion, with little tissue loss, and allow easy visualization of healing.||percentage (%)||95% Confidence Interval|Mean
638900|NCT02418468|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) at 12 Weeks|To compare the effects of indacaterol 150ug once dialy (od) to placebo in GOLD 2014 Group B COPD patients, in terms of 24-hour postdose (trough) forced expiratory volume in 1 second (FEV1) after 12 weeks of dosing.|at week 12|Full Analysis Set (FAS) - would include all randomized patients who received at least one dose of study drug. Following the intent-to-treat principle, patients would be analyzed according to the treatment assigned at randomization.||Liters||Standard Error|Least Squares Mean
638901|NCT02418234|Secondary|Differences of T790M Mutation by ddPCR Among the Different Clinical Modes of TKI Failure|The investigators will employ Analysis of Variance (ANOVA) method to analyze the differences of T790M mutation by ddPCR in patients among the different Clinical modes of TKI failure.|up to 2 years|||percentage of total ctDNA||Full Range|Median
638902|NCT02418234|Secondary|Number of T790M Mutation by ARMS and ddPCR Assays in Each Different Clinical Modes of TKI Failure|The investigators will describe the number of participants with T790M mutation in each different clinical mode of TKI failure by ARMS and ddPCR, and employ chi-square test to analyze the distribution of T790M mutation by ARMS and ddPCR in patients among the different Clinical modes of TKI failure.|up to 2 years|||participants|||Number
638903|NCT02418234|Primary|Abundance of T790M Mutation Detected by Digital Droplet PCR (ddPCR) Assay in Each Individual Patient|The investigators will describe the abundance of T790M mutation on ctDNA detected by ddPCR assay in patients with NSCLC resistant to TKIs.|up to 2 years|||percentage of total ctDNA||Full Range|Median
638904|NCT02418234|Primary|Number of Patients With T790M Mutation Detected by Amplification Refractory Mutation System (ARMS) Assay|The investigators will describe the number of T790M mutation on ctDNA detected by ARMS assay in patients with non-small cell lung cancer (NSCLC) resistant to tyrosine kinase inhibitors (TKIs).|up to 2 years|||participants|||Number
638905|NCT02418026|Secondary|Non-steroidal Anti-inflammatory Drug Intake||day 3|||participants|||Number
638906|NCT02418026|Secondary|Mean Pulse||for 2 hours in the recovery room at regular intervals (average)|||bpm||Standard Deviation|Mean
638907|NCT02418026|Secondary|Mean Pulse||during surgery (average), up to 2 hours|||bpm||Standard Deviation|Mean
638908|NCT02418026|Secondary|Mean Pulse||preoperative, up to 2 hours|||bpm||Standard Deviation|Mean
638909|NCT02418026|Secondary|Mean Blood Pressure||for 2 hours in the recovery room at regular intervals (average)|||mm Hg||Standard Deviation|Mean
638910|NCT02418026|Secondary|Mean Blood Pressure||during surgery (average), up to 2 hours|||mm Hg||Standard Deviation|Mean
638911|NCT02418026|Secondary|Mean Blood Pressure||preoperative, up to 2 hours|||mm Hg||Standard Deviation|Mean
638912|NCT02418026|Secondary|Score at Numeric Pain Rating Scale|The numeric pain rating scale range from 0 (no pain) to 10 (worst pain imaginable)|day 3|||units on a scale||Standard Deviation|Mean
638913|NCT02418026|Secondary|Score at Numeric Pain Rating Scale|The numeric pain rating scale ranges from 0 (no pain) to 10 (worst pain imaginable)|day 1|||units on a scale||Standard Deviation|Mean
638914|NCT02418026|Secondary|Score at Numeric Pain Rating Scale|The numeric pain rating scale ranges from 0 (no pain) to 10 (worst pain imaginable)|just after surgery, up to 1 hour|||units on a scale||Standard Deviation|Mean
638915|NCT02418026|Secondary|Wellbeing Measured Using a Comfort Scale|The comfort scale is a numeric rating scale ranging from 0 to 10 : 0 corresponds to “no comfort” and 10 corresponds to “most comfortable”.|Day 3|||units on a scale||Standard Deviation|Mean
638916|NCT02418026|Secondary|Wellbeing Measured Using a Comfort Scale|The comfort scale is a numeric rating scale ranging from 0 to 10 : 0 corresponds to “no comfort” and 10 corresponds to “most comfortable”.|Day 2|||units on a scale||Standard Deviation|Mean
638917|NCT02418026|Primary|Wellbeing Measured Using a Comfort Scale|The comfort scale is a numeric rating scale ranging from 0 to 10 : 0 corresponds to “no comfort” and 10 corresponds to “most comfortable”.|just after surgery, up to 1 hour|||units on a scale||Standard Deviation|Mean
638918|NCT02417961|Secondary|The Immunogenicity of Benralizumab in the Terms of Anti-drug Antibodies (ADA)|Anti-drug antibodies (ADA) responses at baseline and post baseline. Persistently positive is defined as positive at >=2 post-baseline assessments (with >=16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive is defined as having at least one post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive|Baseline until Week 28|Full analysis set - all patients who were administered for at least one dose of Benralizumab.||Participants|||Number
638919|NCT02417961|Secondary|The Pharmacodynamics of Benralizumab in the Terms of Peripheral Blood Eosinophil Levels|Blood eosinophil counts by timepoint|Baseline, Week 20, and Week 28|Full analysis set - all patients who were administered for at least one dose of Benralizumab.||cells/ uL||Standard Deviation|Mean
638920|NCT02417961|Secondary|The Pharmacokinetics (PK) of Benralizumab in the Terms of PK Parameters: Serum Concentration of Benralizumab|Mean PK Concentration at each visit|Baseline, Week 8, Week 20, and Week 28|PK analysis set - include all patients who had at least one quantifiable serum PK observation post first dose of Benralizumab.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
638921|NCT02417961|Secondary|The Effect of Benralizumab on Asthma Control Metrics in Terms of Change From Baseline in Mean Asthma Control Questionnaire-6 (ACQ-6) Score|The effect of benralizumab on asthma control metrics in terms of change from baseline in mean Asthma Control Questionnaire-6 (ACQ-6) score. ACQ-6 score is defined as the average of the first 6 items of the ACQ questionnaire on symptoms, activity limitations, and rescue medication. Baseline is defined as the last non-missing observation prior to the first dose of study treatment. ACQ-6 contains one bronchodilator question and 5 symptom questions. Questions are rated from 0 (totally controlled) to 6 (severely uncontrolled). Mean ACQ-6 score is the average of the responses. Smaller score indicates better controlled asthma.|Week 0 (baseline) and weeks 4, 8, 12, 16, 20|Full analysis set - all patients who were administered for at least one dose of Benralizumab.||Scores on a scale||Standard Deviation|Mean
638922|NCT02417961|Primary|Number and Percentage of APFS Used to Administer Benralizumab at Home or in the Clinic and Have Been Reported as Malfunctioning (Product Complaints)|Number (%) of APFS used to administer benralizumab at home or in the clinic and have been reported as malfunctioning (Product Complaints). The percentage is calculated based on APFS dispensed and used for the specified time point.|Weeks 0, 4, 8, 12, 16, 0 to 8, 12 to 16, and 0 to 16|Number of Units analyzed per row represents number of accessorized pre-filled syringes used at each time point.||Accessorized Pre-filled Syringe|Accessorized Pre-filled Syringe||Count of Units
638923|NCT02417961|Primary|Number and Percentage of Returned APFS Used to Administer Benralizumab at Home That Have Been Evaluated as Functional|Number (%) of returned APFS used to administer benralizumab at home that have been evaluated as functional among all returned APFS used to administer benralizumab at home. A functional APFS is defined as an answer of “Yes” to all the questions in the visual inspection and function tests. The percentage is calculated among all returned APFS at the specified time point.|Week 12, Week 16|Full analysis set - all patients who were administered for at least one dose of Benralizumab.||Participants|||Count of Participants
638924|NCT02417961|Primary|Number and Percentage of Patients/Caregivers Who Successfully Administered Benralizumab 30 mg Subcutaneously (SC) by Injection With an APFS at Home|Number (%) of patients/caregivers who successfully administered benralizumab with an APFS at home among those who have been deemed by the Principal Investigator to be suitable for at-home administration and are still in the study. A successful administration is defined as an injection completed, an answer of “Yes” to all 5 questions in the Functioning Device Return Questionnaire for the GREGALE Clinical Study (Appendix to the Clinical Study Protocol), and adequately passed the visual inspection and function tests. The percentage is calculated among all patients/caregivers who had been deemed by the Principal Investigator to be suitable for at home administration and were still in the study at the time point.|Week 12, Week 16, and Weeks 12 and 16|Full analysis set - all patients who were administered for at least one dose of Benralizumab.||Participants|||Count of Participants
638925|NCT02417753|Secondary|Overall Survival (PFS) in Patients With Malignant Ascites Treated With AZD9150|OS is defined as the time from the first day of treatment to the day of death.|1.5 years|This outcome measure was not done because the one patient did not make it to one scan after 8 weeks.|||||
638926|NCT02417753|Secondary|Progression Free Survival (PFS) in Patients With Malignant Ascites Treated With AZD9150|PFS is the time interval from start of treatment to documented evidence of progressive disease. Progressive disease was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Progressive disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). in addition to the relative increase of 29%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).|1.5 years|This outcome measure was not done because the one patient did not make it to one scan after 8 weeks.|||||
638927|NCT02417753|Secondary|Count of Participants With Serious and Non Serious Adverse Events|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|4 months and 15 days|||Participants|||Count of Participants
638928|NCT02417753|Secondary|Response Rate (RR) in Patients With Malignant Ascites Treated With AZD9150|Response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and is measured from the time measurement criteria are met for complete response or partial response (whichever is recorded first) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Complete response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.|1.5 years|This outcome measure was not done because the one patient did not make it to one scan after 8 weeks.|||||
638929|NCT02417753|Secondary|Reduction in Tyrosine-phosphorylated Signal Transducer and Activator of Transcription 3 (STAT3) Phospho- Signal Transducer and Activator of Transcription 3 (p- STAT3) Expression, Comparing Before and After Therapy, in Ascites and Peripheral Blood|Measure the reduction in tyrosine-phosphorylated STAT3 (p=STAT3) expression.|1.5 years|This outcome measure was not done because the one patient did not make it to one scan after 8 weeks.|||||
638930|NCT02417753|Secondary|Effect on Signal Transducer and Activator of Transcription 3(STAT3)-Dependent & Associated Signaling Both in Tumor Cells, Peripheral Blood and the Microenvironment, Including Modulations in Chemokine and Cytokine Response Following Treatment With AZD9150|Serum samples were to be collected from participants and assessed for interferon, cytokine and chemokine levels including interferon, ϒ-interferon inducible protein (IP-10), monocyte chemoattractant protein 1 (MCP-1), interleukin 6 (IL-6), interleukin 8 (IL-8), interleukin 10 (IL-10), and interleukin 12/p70 (IL-12/p70).|1.5 years|This outcome measure was not done because the one patient did not make it to one scan after 8 weeks.|||||
638931|NCT02417753|Primary|Changes in Immune Parameters in the Malignant Ascites of Patients With Advanced Cancer Following Therapy With AZD9150|Participants were to undergo research paracentesis. Ascitic fluid was to be obtained and processed for changes in the percentages of memory cluster of differentiation 8 (CD8) + cells, regulatory T cells, plasmacytoid dendritic cell (pDC), B cells and natural killer (NK) cells will be analyzed by flow cytometry.|1.5 years|This outcome measure was not done because the one patient did not make it to one scan after 8 weeks.|||||
638932|NCT02417532|Secondary|Timed up and go Test- Ability to Stand From Chair|Walk 3 m and turn around and walk back to the chair. (Functional test)|1 Day|Subjects who met all inclusion/exclusion criteria||Participants|||Count of Participants
638933|NCT02417532|Secondary|Participant Satisfaction Questionnaire|overall user satisfaction with the device|1 Day|All subjects meeting inclusion criteria||percentage of patients|||Number
638934|NCT02417532|Secondary|Competency of User, in First Use, in Autonomous Control of the Device in <10 Minutes|Competent ability of user to use device within the first 10 Minutes without assistance|1 Day|All patients meeting inclusion criteria||Participants|||Count of Participants
638935|NCT02417532|Secondary|User Transfer, in First Use|Ability to transfer to Rex in first use of device|1 day|All subjects meeting inclusion criteria||Participants|||Count of Participants
638936|NCT02417532|Primary|Adverse Events|absence of unexpected serious adverse events|1 day|||Participants|||Count of Participants
638937|NCT02417532|Primary|Completion of REXercise 2|Lateral Trunk Extension|1 day|All Subjects meeting inclusion criteria||Participants|||Count of Participants
638938|NCT02417532|Primary|Completion of REXercise 1|Bilateral Shoulder Abduction|1 day|All subjects meeting inclusion criteria||Participants|||Count of Participants
638939|NCT02417532|Primary|Completion of Transfer|Completion of transfer from wheelchair or bed to REX device|1 day|All subjects meeting inclusion criteria. Physically able to properly fit in REX.||participants|||Number
638940|NCT02417376|Secondary|Diastolic Blood Pressure at 6 Months|Diastolic blood pressure at 6 months.|6 months|||mmHg||Standard Deviation|Mean
638941|NCT02417376|Secondary|Diastolic Blood Pressure at 3 Months|Diastolic blood pressure at 3 months.|3 months|||mmHg||Standard Deviation|Mean
638942|NCT02417376|Secondary|Diastolic Blood Pressure at 1 Month|Diastolic blood pressure at 1 month.|1 month|||mmHg||Standard Deviation|Mean
638943|NCT02417376|Secondary|Change From Baseline Periodontal Parameter- Clinical Attachment Loss at 6 Months|Change from baseline in periodontal parameter- clinical attachment loss at 6 months.|Baseline and 6 months|||mm||Standard Deviation|Mean
638944|NCT02417376|Secondary|Change From Baseline Periodontal Parameter- Bleeding on Probing at 6 Months|Change from baseline in periodontal parameter- bleeding on probing at 6 months.|Baseline and 6 months|||percentage of sites||Standard Deviation|Mean
638977|NCT02415439|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) After a Single Dose of VBP15 (0 Through 72 Hours Post Dose)||Participants will be followed for the duration of hospital stay of 4 days|||(hr*ng/mL)||Standard Deviation|Mean
638945|NCT02417376|Secondary|Change From Baseline Periodontal Parameter- Plaque Index at 6 Months|Change from baseline in periodontal parameter- plaque index at 6 months. Scale ranges for Total Plaque Index - Minimum score (0) and maximum score (3). Score 0 represents better outcome and higher scores represent worst outcome. Score per person are calculated by taking average of scores for 6 sites of all teeth recorded.|Baseline and 6 months|||Scores on a scale||Standard Deviation|Mean
638946|NCT02417376|Secondary|Change From Baseline Periodontal Parameter- Gingival Index at 6 Months|"Change from baseline in periodontal parameter- gingival index at 6 months. Scale ranges for Total Gingival Index - Minimum score (0) and maximum score (3).
Score 0 represents better outcome and higher scores represent worst outcome. Score per person are calculated by taking average of scores for 6 sites of all teeth recorded."|Baseline and 6 months|||Scores on a scale||Standard Deviation|Mean
638947|NCT02417376|Secondary|Change From Baseline Periodontal Parameter- Periodontal Probing Depth at 6 Months|Change from baseline in periodontal parameter- periodontal probing depth at 6 months.|Baseline and 6 months|||mm||Standard Deviation|Mean
638948|NCT02417376|Secondary|Systolic Blood Pressure at 6 Months|Systolic blood pressure at 6 months.|6 months|||mmHg||Standard Deviation|Mean
638949|NCT02417376|Secondary|Systolic Blood Pressure at 3 Months|Systolic blood pressure at 3 months.|3 months|||mmHg||Standard Deviation|Mean
638950|NCT02417376|Secondary|Systolic Blood Pressure at 1 Month|Systolic blood pressure at 1 month.|1 month|||mmHg||Standard Deviation|Mean
638951|NCT02417376|Secondary|Change From Baseline WBC Profile at 6 Months|Change from baseline in white blood cell profile assessed at 6 months.|Baseline and 6 months|||per cmm||Standard Deviation|Mean
638952|NCT02417376|Secondary|Change From Baseline WBC Profile at 3 Months|Change from baseline in white blood cell profile assessed at 3 months.|Baseline and 3 months|||per cmm||Standard Deviation|Mean
638953|NCT02417376|Secondary|Change From Baseline WBC Profile at 1 Month|Change from baseline in white blood cell profile assessed at 1 month.|Baseline and 1 month|||per cmm||Standard Deviation|Mean
638954|NCT02417376|Secondary|Change From Baseline in Lipid Profile at 6 Months.|Change from baseline in lipid profile assessed at 6 months.|Baseline and 6 months|||mg/dl||Standard Deviation|Mean
638955|NCT02417376|Secondary|Change From Baseline in Lipid Profile at 3 Months|Change from baseline in lipid profile assessed at 3 months.|Baseline and 3 months|||mg/dl||Standard Deviation|Mean
638956|NCT02417376|Secondary|Change From Baseline in Lipid Profile at 1 Month|Change from baseline in lipid profile assessed at 1 month.|Baseline and 1 month|||mg/dl||Standard Deviation|Mean
638957|NCT02417376|Secondary|Change From Baseline in C-Reactive Protein Level at 3 Month|Change from baseline in high-sensitivity C-reactive protein level assessed quantitatively by immunoturbidimetric analysis at 3 months.|Baseline and 3 months|||mg/L||Standard Deviation|Mean
638958|NCT02417376|Secondary|Change From Baseline in C-Reactive Protein Level at 1 Month|Change from baseline in high-sensitivity C-reactive protein level assessed quantitatively by immunoturbidimetric analysis at 1 month.|Baseline and 1 month|||mg/L||Standard Deviation|Mean
638959|NCT02417376|Primary|Change From Baseline in C-Reactive Protein Level at 6 Months|Change from baseline in high-sensitivity C-reactive protein level assessed quantitatively by immunoturbidimetric analysis at 6 months.|Baseline and 6 months|All patients suffered from CHD and Periodontitis both.||mg/L||Standard Deviation|Mean
638960|NCT02417129|Secondary|Immunogenicity at Week 30|"Immunogenicity (rate of anti-drug antibodies) at Week 30 presented as the number of participants having Immunogenicity at Week 30.
This endpoint was not summarized for arm ' rituximab ', as two patient were randomized and treated with BI 695500, thus no patient was treated with rituximab in this trial."|Day 204 or end of study|Safety Analysis Set (SAF). As the program was prematurely discontinued and only two patients were randomized at the time of discontinuation, the planned statistical analysis was not performed.||participants|||Number
638961|NCT02417129|Secondary|Extrapolated Area Under the Concentration-time Curve of BI 695500 or Rituximab at Steady State Over the Interval 0 Hour (h) to the Next Dose of Trial Medication (AUC0-τ, ss)|Extrapolated area under the concentration-time curve of BI 695500 or rituximab in plasma at steady state over the interval 0 hour (h) to the next dose of trial medication (AUC0-τ, ss) established by population pharmacokinetics.|Sample timepoints Day 1, 8, 22, 23-24 (24-48 hours from start of Cycle 4 infusion), 24-26 (48-96 hours from start of Cycle 4 infusion), 26-36 (96-336 hours from start of Cycle 4 infusion), 78, 134, 204|As the program was prematurely discontinued and only two patients were randomized at the time of discontinuation, the planned statistical analysis was not performed.|||||
638962|NCT02417129|Primary|Overall Response Measured as Overall Response Rate (ORR) at Week 30 for BI 695500 Versus Rituximab|"The primary objective of this trial was to evaluate statistical equivalence of efficacy as assessed by Overall Response (measured as Overall Response Rate (ORR)) at Week 30 for treatment with BI 695500 versus rituximab (Rituxan®) in patients with untreated low tumor burden follicular lymphoma (LTBFL).
The overall response measured as Overall Response Rate (ORR), which is the completed response (CR) and the partial response (PR) at Week 30, approximately 26 weeks after the completion of study treatment, as defined by International Working Group (IWG) criteria 2007 via an independent radiology assessment.
Two patient were randomized and treated with BI 695500, whereas no patient was treated with rituximab in this trial."|From first administration of study medication until 30 weeks thereafter.|As the program was prematurely discontinued and only two patients were randomized at the time of discontinuation, the planned statistical analysis was not performed.||participants|||Number
638963|NCT02416973|Primary|Percent Change From Baseline in Pain Scores|Numerical Pain Rating Scale (NPRS) was used to score pain at Baseline and at End of Treatment. The Percent change (difference) from Baseline to End of Treatment was calculated. The NPRS is an 11-point scale ranging from scores of 0 (no pain) to 10 (worst pain imaginable).|60 days|Per protocol population results displayed. This results in a discrepancy in the number of participants provided above. Baseline characteristics include the entire intent to treat population.||Percent Difference||Standard Deviation|Mean
638978|NCT02415439|Primary|Number of Subjects With Adverse Effects After a Single Dose of VBP15||Participants will be followed for the duration of hospital stay of 4 days|||participants|||Number
638996|NCT02413593|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: all enrolled participants who received at least 1 dose of study drug.||percentage of participants||95% Confidence Interval|Number
638964|NCT02416180|Secondary|Time Taken to Correctly Completing Inhaler Use at Day 14|If a participant made a critical error during the initial assessment, the HCP demonstrated the correct use of the inhaler to the participant and gave verbal instructions. The HCP could have demonstrated the use of the inhaler a maximum of three times. Any errors made after this final demonstration were recorded. The time taken for the HCP to train the participant in the correct technique was recorded as T1: the time from when the participants started their demonstration of MDI use until they had completed their demonstration of MDI use (i.e., with no HCP support), T2: the time from when the HCP started to demonstrate/instruct device use until correct use was demonstrated by the participant (up to a maximum of three attempts only). T3 is defined as T1+T2, which is the time from when the participant started to demonstrate MDI use until correct use was demonstrated by the subject (up to a maximum of three attempts following demonstration by HCP).|Day 14|ITT Population||Minutes||Full Range|Median
638965|NCT02416180|Secondary|Number of Health Care Professional (HCP) Instructions Required on Day 14|Participant's inhaler use was assessed on Day 14 by the HCP against a predefined list of critical errors. If a participant made a critical error during this initial assessment, the HCP demonstrated the correct use of the inhaler to the participant and gave verbal instructions. The participant was then asked to demonstrate inhaler use. Any errors were recorded by the HCP. If the participant made a critical error then the HCP repeated the demonstration of inhaler use to the participant for a second time. If the participant continued to make a critical error in the use of the inhaler, the HCP demonstrated the correct use of the inhaler and gave verbal instructions one more time and the participant was then asked to demonstrate inhaler use. Instructions are only given to subjects who make a critical error. Any errors made after this final demonstration were recorded.|Day 14|ITT Population||Participants|||Number
638966|NCT02416180|Secondary|Percentage of Participants Making at Least One Overall Error After the First Assessment of MDI Technique on Day 14.|Inhaler use was assessed on Day 14 for overall errors. Overall errors included CEs or N-CEs. Demonstration of usage was with MDI and placebo, CE or N-CEs and even no errors were recorded. CEs were defined as: failure to remove the cap; failure to shake the device; failure to place the device in mouth; no dose actuated during an inhalation manoeuvre; dose coordination that was so poor that the patient was likely to have received no dose or only received minimal dose. N-CEs were defined as: failure to inhale within 5 seconds of shaking the device; no exhalation before an inhalation; the inhalation manoeuvre was not slow and/or was not deep; dose coordination was sub-optimal but patient likely to have received some dose; more than one actuation during an inhalation manoeuvre; did not hold breath. The exact 95% confidence interval is for percent of participants making at least one CE after the first assessment of the MDI technique, and was calculated using exact binomial distribution.|Day 14|ITT population||Percentage of participants||95% Confidence Interval|Number
638967|NCT02416180|Primary|Percentage of Participants Making at Least One Critical Error After the First Assessment of Metered Dose Inhaler (MDI) Technique on Day 14|Participant's inhaler use was assessed on Day 14 by the health care professional (HCP) against a predefined list of critical errors (CEs). Critical errors were defined as errors that were most likely to result in no or only minimal medication being inhaled. The participants were asked to demonstrate their usage of the MDI using a placebo demonstration MDI by HCP, critical or non-critical errors (N-CEs) and even no errors made by the participants while using the MDI were recorded. Critical errors in using the MDI were defined as: failure to remove the cap; failure to shake the device; failure to place the device in mouth; no dose actuated during an inhalation manoeuvre; dose coordination that was so poor that the patient was likely to have received no dose or only received minimal dose. 95% confidence interval (CI) is for the % of participants making at least one critical error after the first assessment of the MDI technique, and was calculated using the exact binomial distribution.|Day 14|Intent to Treat (ITT) population: comprised of all participants who were screened and received at least one dose of study medication.||Percentage of Participants||95% Confidence Interval|Number
638968|NCT02415959|Other Pre-specified|Treatment Emergent Adverse Events|Treatment emergent adverse events will be summarized per treatment group|From randomization to end of Double Blind period plus 1 day, i.e. up to 7/8 days|||participants|||Number
638969|NCT02415959|Secondary|Stool Weight|Total amount of stool weight during the collection period in grams|End of the 6 to 7 days double-blind treatment period|Full Analysis set. Four randomized subjects excluded because no post-baseline efficacy data (two non-completers and two subjects whose stools were mixed-up with each other at the analytical laboratory).||gram per 72 hours||Standard Deviation|Mean
638970|NCT02415959|Secondary|Stool Fat Content|Total amount of fat excreted during the stool collection period in grams.|End of the 6 to 7 days double-blind treatment period|Full Analysis set. Four randomized subjects excluded because no post-baseline efficacy data (two non-completers and two subjects whose stools were mixed-up with each other at the analytical laboratory).||gram per 72 hours||Standard Deviation|Mean
638971|NCT02415959|Secondary|Coefficient of Nitrogen Absorption (CNA)|CNA is calculated from nitrogen intake and nitrogen excretion, according to the formula: CNA (%) = 100 [nitrogen intake - nitrogen excretion] / nitrogen intake)|End of the 6 to 7 days double-blind treatment period|Full Analysis set. Four randomized subjects excluded because no post-baseline efficacy data (two non-completers and two subjects whose stools were mixed-up with each other at the analytical laboratory).||percentage of nitrogen intake||Standard Deviation|Mean
638972|NCT02415959|Primary|Coefficient of Fat Absorption (CFA)|CFA is calculated from fat intake and fat excretion, according to the formula: CFA (%) = 100 [fat intake - fat excretion] / fat intake|End of the 6 to 7 days double-blind treatment period|Full Analysis set. Four randomized subjects excluded because no post-baseline efficacy data (two non-completers and two subjects whose stools were mixed-up with each other at the analytical laboratory).||percentage of fat intake||Standard Deviation|Mean
638973|NCT02415439|Primary|Peak Plasma Concentration (Cmax) of VBP15 After 14 Daily Doses of VBP15||Participants will be followed for the duration of hospital stay of 15 days|||(ng/mL)||Standard Deviation|Mean
638974|NCT02415439|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) After 14 Daily Doses of VBP15 (0 Through 72 Hours Post Dose)||Participants will be followed for the duration of hospital stay of 15 days|||(hr*ng/mL)||Standard Deviation|Mean
638975|NCT02415439|Primary|Number of Subjects With Adverse Effects After 14 Daily Doses of VBP15||Participants will be followed for the duration of hospital stay of 15 days|||participants|||Number
638976|NCT02415439|Primary|Peak Plasma Concentration (Cmax) of VBP15 After a Single Dose of VBP15||Participants will be followed for the duration of hospital stay of 4 days|||(ng/mL)||Standard Deviation|Mean
638979|NCT02414828|Secondary|"Immunogenicity of AERAS-402 Based on the Percentage of CD8 Cells of Participants in the Post TB Treatment Stratum"|Assessment of immune response to AERAS-402 was based on the percentage of CD4 and CD8 T cells producing any combination of three cytokines (IFN-γ, TNF-α, and/or IL-2) following stimulation with mycobacterial peptide pools derived from and representing the entire amino acid sequences of mycobacterial antigens Ag85A, Ag85B, and TB10.4. Responses were measured by the intracellular cytokine staining (ICS) assay using flow cytometry.|42 days post dose|||percentage of T Cell response||95% Confidence Interval|Median
638980|NCT02414828|Secondary|"Immunogenicity of AERAS-402 Based on the Percentage of CD4 Cells of Participants in the Post TB Treatment Stratum"|Assessment of immune response to AERAS-402 was based on the percentage of CD4 and CD8 T cells producing any combination of three cytokines (IFN-γ, TNF-α, and/or IL-2) following stimulation with mycobacterial peptide pools derived from and representing the entire amino acid sequences of mycobacterial antigens Ag85A, Ag85B, and TB10.4. Responses were measured by the intracellular cytokine staining (ICS) assay using flow cytometry.|42 days post dose|||percentage of T Cell response||95% Confidence Interval|Median
638981|NCT02414828|Secondary|"Immunogenicity of AERAS-402 Based on the Percentage of CD8 Cells of Participants in the on TB Treatment Stratum"|Assessment of immune response to AERAS-402 was based on the percentage of CD4 and CD8 T cells producing any combination of three cytokines (IFN-γ, TNF-α, and/or IL-2) following stimulation with mycobacterial peptide pools derived from and representing the entire amino acid sequences of mycobacterial antigens Ag85A, Ag85B, and TB10.4. Responses were measured by the intracellular cytokine staining (ICS) assay using flow cytometry.|42 days post dose|||percentage of T Cell response||95% Confidence Interval|Median
638982|NCT02414828|Primary|Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)|Maximum number of subjects with deterioration >15% from baseline, at any time point, in diffusing capacity of the lung for carbon monoxide (DLCO)|182 Days|Subjects who were evaluated.||participants|||Number
638983|NCT02414828|Primary|Forced Vital Capacity (FVC)|Maximum number of subjects with deterioration >10% from baseline, at any time point, in forced vital capacity (FVC)|182 days|Subjects who were evaluated.||participants|||Number
638984|NCT02414828|Primary|Forced Expiratory Volume in One Second (FEV1)|Maximum number of subjects with deterioration >10% from baseline, at any time point. in forced expiratory volume in one second (FEV1)|182 days|Subjects who were evaluated.||participants|||Number
638985|NCT02414828|Secondary|"Immunogenicity of AERAS-402 Based on the Percentage of CD4 Cells of Participants in the on TB Treatment Stratum"|Assessment of immune response to AERAS-402 was based on the percentage of CD4 and CD8 T cells producing any combination of three cytokines (IFN-γ, TNF-α, and/or IL-2) following stimulation with mycobacterial peptide pools derived from and representing the entire amino acid sequences of mycobacterial antigens Ag85A, Ag85B, and TB10.4. Responses were measured by the intracellular cytokine staining (ICS) assay using flow cytometry.|42 days post dose|||percentage of T Cell response||95% Confidence Interval|Median
638986|NCT02414828|Primary|Number of Participants With Solicited and Unsolicited AEs|All adverse events will be summarized to examine the relationship between dose levels including number (percentage) of solicited and unsolicited adverse events (AEs), and number (percentage) of subjects with newly abnormal post-vaccination laboratory values based on predefined toxicity criteria.|182 days|||participants|||Number
638987|NCT02414152|Primary|Response to Anakinra in Corticosteroid Resistant Patients With SSNHL|Patients who had a response to anakinra based on hearing threshold improvement compared to their pre-treatment threshold.|120 days|Zero subjects were analyzed because both enrolled subjects were withdrawn after receiving 56 days of anakinra because no hearing improvement was noted. They did not complete the entire study.|||||
638988|NCT02413879|Secondary|Efficacy (Bacterial Contamination on the Exposed Surface of the CleanCision Sheath Compared to the Protected Incision Edge)|Comparison of bacterial contamination on the exposed surface of the CleanCision sheath compared to the protected incision edge|1 day (end of the procedure and removal of the investigational device)|Two subjects did not have swab results and thus were not included in the intention-to-treat analysis.||% of participants with contamination|||Number
638989|NCT02413879|Primary|Safety (Serious Adverse Events Directly Attributable to the Device)|Incidence of Serious Adverse Events directly attributable to the device|30 days|All subjects within the Treatment arm were analyzed (Intention-to-treat).||Participants|||Count of Participants
638990|NCT02413879|Primary|Efficacy (Enteric Bacterial Contamination on the Exposed Surface of the CleanCision Sheath Compared to the Protected Incision Edge)|Comparison of enteric bacterial contamination on the exposed surface of the CleanCision sheath compared to the protected incision edge|1 day (end of the procedure and removal of the investigational device)|Two subjects did not have swab results and thus were not included in the intention-to-treat analysis.||% of participants with contamination|||Number
638991|NCT02413593|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as:
On-treatment virologic failure:
Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)
Virologic relapse:
Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 12|Full Analysis Set||percentage of participants|||Number
638992|NCT02413593|Secondary|Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12||Baseline; Weeks 1, 2, 4, 8, and 12|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
638993|NCT02413593|Secondary|Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8 and 12||Weeks 1, 2, 4, 8, and 12|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants||95% Confidence Interval|Number
638994|NCT02413593|Secondary|Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)|SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.|Posttreatment Week 4|Full Analysis Set||percentage of participants||95% Confidence Interval|Number
638995|NCT02413593|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 12 weeks|Safety Analysis Set||percentage of participants|||Number
639063|NCT02411539|Secondary|Total/Inducible Virus Recovery - Unstimulated Cell Fluor|As part of the total virus recovery assay, results for unstimulated cell fluor (light units) are generated.|Measured at pre-entry, week 6 and week 12|Includes all participants with available unstimulated cell fluor results from virus recovery assay||million light units||Inter-Quartile Range|Median
638997|NCT02413333|Secondary|Mean Osmolality in Lens Cases at Day 30|The used lens case was collected after approximately 30 days of use. Remaining liquid was removed and dry cases were shipped to a lab for analysis. 10 mL of the appropriate solution was added to each collected case. Osmolality was measured at the manufacturers minimum recommended storage time (6 hours for Clear Care Plus and 4 hours for PeroxiClear).|Day 30, each product|Intention to treat participants with non-missing observations||milliosmoles/kg (mOsm/kg)|Participants|Standard Deviation|Mean
638998|NCT02413333|Primary|Mean Residual Peroxide at Day 30|The used lens case was collected after approximately 30 days of use. Remaining liquid was removed and dry cases were shipped to a lab for analysis. 10 mL of the appropriate solution was added to each collected case. Residual peroxide was measured at the manufacturers minimum recommended storage time (6 hours for Clear Care Plus and 4 hours for PeroxiClear).|Day 30, each product|Intention to treat participants with non-missing observations||parts per million (ppm)|Participants|Standard Deviation|Mean
638999|NCT02413294|Secondary|Self-Reported Sleep Diary: Sleep Duration|nightly mean of length of sleep measured in minutes|daily for 4 weeks- baseline and intervention period to be compared|||Minutes asleep||Standard Deviation|Mean
639000|NCT02413294|Secondary|Self-Reported Sleep Diary: Night Awakenings|mean number of night awakenings per person per night as reported in sleep diaries|daily for 4 weeks- baseline and intervention period to be compared|||Number of night awakenings||Standard Deviation|Mean
639001|NCT02413294|Secondary|Self-Reported Sleep Diary: Sleep Quality|sleep quality is a participants' mean self-report for each of the two week periods: baseline and intervention. Sleep quality is reported for each night on a scale of 0 (very poor) to 4 (very good).|daily for 4 weeks- baseline and intervention period to be compared|||units on a scale||Standard Deviation|Mean
639002|NCT02413294|Secondary|Self-Reported Sleep Diary: Time at Which Participants Wake up|Wake time represents the moment in time at which participants awaken. Time between actual hours is calculated on a decimal basis so an additional 6 minutes = .1. so that 7.5 represents 7:30 a.m. and 7.8 represents 7:48 a.m.|daily for 4 weeks- baseline and intervention period to be compared|||hour (military time)||Standard Deviation|Mean
639003|NCT02413294|Secondary|Self-Reported Sleep Diary: Time at Which Participants go to Bed|Bed time represents the moment in time at which participants went to bed, measured on a revised clock where 6pm = 18, Midnight = 24 and 6am =30. Time between actual hours is calculated on a decimal basis, so an additional 6 minutes = .1. This revised clock is necessary in order to make means work properly in the nighttime hours. Otherwise, averaging between a 10pm bedtime and a 2am bedtime would give the impossible, inaccurate mean of being in the daytime between those two numbers.|daily for 4 weeks- baseline and intervention period to be compared|||hour (military time)||Standard Deviation|Mean
639004|NCT02413294|Secondary|Fitbit Sleep Data: Sleep Efficiency|Sleep efficiency is calculated as a percentage reflecting the amount of time in bed spent asleep (time asleep/time in bed x 100).|daily for 4 weeks- baseline and intervention period|||percentage of time in bed spent asleep||Standard Deviation|Mean
639005|NCT02413294|Secondary|Fitbit Sleep Data: Night Awakenings|mean nightly awakenings for each of the two week periods: baseline and intervention. Similar to the actigraph the Fitbit counts awakenings through an accelerometer which measures motion.|daily for 4 weeks- baseline and intervention period|||count of night awakenings||Standard Deviation|Mean
639006|NCT02413294|Secondary|Fitbit Sleep Data: Sleep Duration|mean nightly sleep duration in minutes for each of the two-week periods: baseline and intervention|daily for 4 weeks- baseline and intervention period|||Minutes asleep||Standard Deviation|Mean
639007|NCT02413294|Secondary|Actigraph: Efficiency|Sleep efficiency is calculated as a percentage reflecting the amount of time in bed spent asleep (time asleep/time in bed x 100). The mean for each of the two-week periods: baseline and intervention, is calculated.|daily for 4 weeks- baseline and intervention period|||percentage of time in bed spent asleep||Standard Deviation|Mean
639008|NCT02413294|Secondary|Actigraph: Number of Awakenings|Actigraphy counts awakenings by using an accelerometer to assess motion during the night. The number of awakenings is the mean nightly number of awakenings during each of the two-week periods: baseline and intervention.|daily for 4 weeks- baseline and intervention period|||count of awakenings||Standard Deviation|Mean
639009|NCT02413294|Secondary|Actigraph Sleep Data: Minutes Asleep|mean nightly sleep duration for each of the two-week periods: baseline and intervention|daily for 4 weeks- baseline and intervention period|||minutes||Standard Deviation|Mean
639010|NCT02413294|Primary|Morningness-Eveningness Questionnaire|The morningness- eveningness categories represent the time of day when a person is at their peak alertness.|two weeks after introduction of intervention|||Participants|||Count of Participants
639011|NCT02413294|Primary|Insomnia Severity Index Sum Scores|The Insomnia Severity Index measures insomnia severity on a scale from 0 to 28. A score of 15 or higher is indicative of clinical insomnia.|two weeks after introduction of intervention|||units on a scale||Standard Deviation|Mean
639012|NCT02413294|Primary|Patient Health Questionnaire-9 Depression Scale|The PHQ-9 Depression Scale is a validated scale ranging from 0 to 27 with higher numbers representing greater severity of depressive symptoms, based on 9 questions with each question on a scale of 0 - 3.|two weeks after introduction of intervention|||units on a scale||Standard Deviation|Mean
639013|NCT02413294|Primary|Pittsburgh Sleep Quality Index|The Pittsburgh Sleep Quality Index is a validated scale which measures self-reported sleep quality based on a wide variety of questions (duration, quality, disturbances, medication, etc.) and converts them to a scale which ranges from 0 to 21 where 6 or higher denotes poor sleep quality.|two weeks after introduction of intervention|||units on a scale||Standard Deviation|Mean
639014|NCT02413203|Secondary|Urinary Lipid Metabolites: TxB2 Metabolite (Tx-M)|Effect of celecoxib on systemic TxB2 was assessed by comparing urine Tx-M in celecoxib vs placebo-treated groups. Urine data are reported as a percentage of the volunteer’s own pre-dose control using the formula: percentage of pre-dose control = (Cpost-dose/Cpre-dose) × 100%, where C represents metabolite concentration in ng/mg creatinine.|A single visit of around 4 hours|||percentage of pre-dose control||Standard Deviation|Mean
639015|NCT02413203|Secondary|Urinary Lipid Metabolites: PGI2 Metabolite (PGI-M)|Effect of celecoxib on systemic PGI2 was assessed by comparing urine PGI-M in celecoxib vs placebo-treated groups. Urine data are reported as a percentage of the volunteer’s own pre-dose control using the formula: percentage of pre-dose control = (Cpost-dose/Cpre-dose) × 100%, where C represents metabolite concentration in ng/mg creatinine.|A single visit of around 4 hours|||percentage of pre-dose control||Standard Deviation|Mean
639016|NCT02413203|Secondary|Celecoxib Plasma Concentration|Celecoxib plasma concentration will be measured in drug-treated and placebo groups by UPLC-MS/MS, and will be expressed as amount of the drug per volume of plasma (ng/ml). At Tmax of 3 hours after a single oral dose of celecoxib of 200 mg, drug plasma concentration should correspond to the maximum plasma concentration or Cmax.|A single visit of around 4 hours|||ng/ml||Standard Deviation|Mean
639017|NCT02413203|Secondary|Urinary Lipid Metabolites: PGE2 Metabolite (PGE-M)|Effect of celecoxib on systemic PGE2 was assessed by comparing urine PGE-M in celecoxib vs placebo-treated groups. Urine data are reported as a percentage of the volunteer’s own pre-dose control using the formula: percentage of pre-dose control = (Cpost-dose/Cpre-dose) × 100%, where C represents metabolite concentration in ng/mg creatinine.|A single visit of around 4 hours|||percentage of pre-dose control||Standard Deviation|Mean
639018|NCT02413203|Primary|Quantification of Plasma Lipids in the Whole Blood: 15-Hydroxyeicosatetraenoic Acid (15-HETE)|15-HETE in blood taken from celecoxib-treated subjects and stimulated ex vivo with LPS was compared to similarly treated blood from placebo group. Plasma 15-HETE was normalized to sample volume (ng/ml) and expressed as a percentage of subject’s pre-dose control using the formula: percentage of pre-dose control = (Cpost-dose/Cpre-dose) × 100%, where C represents 15-HETE concentration in ng/ml.|A single visit of around 4 hours|||percentage of pre-dose control||Standard Deviation|Mean
639019|NCT02413203|Primary|Quantification of Plasma Lipids in the Whole Blood: Thromboxane B2 (TxB2)|TxB2 in blood taken from celecoxib-treated subjects and stimulated ex vivo with LPS was compared to similarly treated blood from placebo group. Plasma TxB2 was normalized to sample volume (ng/ml) and expressed as a percentage of subject’s pre-dose control using the formula: percentage of pre-dose control = (Cpost-dose/Cpre-dose) × 100%, where C represents TxB2 concentration in ng/ml.|A single visit of around 4 hours|||percentage of pre-dose control||Standard Deviation|Mean
639020|NCT02413203|Primary|Quantification of Plasma Lipids in the Whole Blood: Prostaglandin F2a (PGF2a)|PGF2a in blood taken from celecoxib-treated subjects and stimulated ex vivo with LPS was compared to similarly treated blood from placebo group. Plasma PGF2a was normalized to sample volume (ng/ml) and expressed as a percentage of subject’s pre-dose control using the formula: percentage of pre-dose control = (Cpost-dose/Cpre-dose) × 100%, where C represents PGF2a concentration in ng/ml.|A single visit of around 4 hours|||percentage of pre-dose control||Standard Deviation|Mean
639021|NCT02413203|Primary|Quantification of Plasma Lipids in the Whole Blood: Prostaglandin E2 (PGE2)|PGE2 in blood taken from celecoxib-treated subjects and stimulated ex vivo with LPS was compared to similarly treated blood from placebo group. Plasma PGE2 was normalized to sample volume (ng/ml) and expressed as a percentage of subject’s pre-dose control using the formula: percentage of pre-dose control = (Cpost-dose/Cpre-dose) × 100%, where C represents PGE2 concentration in ng/ml.|A single visit of around 4 hours|||percentage of pre-dose control||Standard Deviation|Mean
639022|NCT02413034|Primary|Sonication Cultures|Number of positive Sonication cultures (7)|14 days|||cultures|||Number
639023|NCT02413034|Primary|Positive Cultures|Number of positive Tissue Cultures (7)|14 days|||cultures|||Number
639024|NCT02412657|Secondary|Patients Overall Satisfaction|categorical data (1: very satisfied, would recommend this analgesia protocol to others, 0: not satisfied, would not recommend this analgesia protocol to others|48 hours||||||
639025|NCT02412657|Secondary|Sleep Disturbance|Sleep disturbance scale 0-10 (0: no sleep disturbance from pain, 10: worst conceivable sleep disruption from pain)|24 hours and 48 hours||||||
639026|NCT02412657|Secondary|Residual Motor Block|Scale of 0-2 (0:inability to move fingers, 1: fingers able to move, with diminished strength compared to non operated side, 2: No motor weakness of the fingers)|24 hours and 48 hours||||||
639027|NCT02412657|Secondary|Pain Scores|On a 11-points Verbal Numeric Scale 0-10 (0= no pain, 10= worst conceivable pain)|every 6 hours during the first 48 hours after surgery||||||
639028|NCT02412657|Secondary|Total Opioid Consumption (mg)||48 hours after surgery||12/2017||||
639029|NCT02412657|Primary|Duration of Analgesia|Defined as the time between the performance of the block and the first analgesic request|48 hours after surgery|||hours||Inter-Quartile Range|Median
639030|NCT02411929|Secondary|Number of Participants Discontinuing Study Drug Due to Adverse Events (Periods 1 and 2)|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to approximately 16 days|The Safety Population included all participants who received at least one dose of study drug.||Participants|||Number
639031|NCT02411929|Secondary|Number of Participants Who Experienced an Adverse Event (Periods 1 and 2)|An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to approximately 33 days|The Safety Population included all participants who received at least one dose of study drug.||Participants|||Number
639032|NCT02411929|Secondary|Pharmacokinetic Parameter: Fraction Absorbed (Fa, Radioactivity in Urine) (Periods 1 and 2) (Dose Normalized)|Fraction absorbed is the fraction of the total ertugliflozin dose absorbed, regardless of the fate of that dose after absorption (i.e., metabolism, degradation, etc). Fraction Absorbed was estimated as the ratio of total radioactivity (dose normalized) excreted into the urine (from time zero to the time of last measurable concentration) following oral and IV administration of 14^C-ertugliflozin. Fraction of 14^C dose recovered in urine = 14^C total in urine in dpm/14^C total in dose in dpm|Part 1: pre- IV dose, 0-11 and 11-23 hrs. post IV dose, and 23 – 47, 47 – 71 and 71 – 95 hrs. until Day 5; Part 2: predose, 0-12 and 12-24 hrs. post dose, and then 24-hour intervals until Day 5|The estimated Fa Population included only the 6 participants with complete urine data for both treatments.||Fraction of 14^C dose recovered in urine||Geometric Coefficient of Variation|Geometric Mean
639047|NCT02411539|Secondary|Plasma Levels of Interleukin-6 (IL-6)|Not conducted as part of primary analysis and there are no future plans to assess this outcome. Samples were collected for this outcome in order to assess associations with virologic effects observed. Due to the lack of virologic effect observed, the study team has decided that this outcome is no longer of priority/interest and will be abandoned in favor of saving these samples for future research purposes.|Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30|Analysis not performed. See outcome measure description for reasoning.|||||
639033|NCT02411929|Secondary|Pharmacokinetic Parameter: Steady-State Volume of Distribution (Vss) Following IV Infusion - IV, Following Administration of Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ertugliflozin 100 ug IV (Period 1)|Steady-State Volume of Distribution is the theoretical volume that the total amount of administered drug would have to occupy (if it were uniformly distributed), to provide the same concentration as it is in blood plasma at steady state. Geometric coefficient of variation is given as the percent coefficient of variation. This outcome measure is for the Ertugliflozin intravenous drug profile only so no participants were analyzed in the Ertugliflozin oral arm.|Oral: 0, 15 and 30 min., and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs. after oral dose; IV: -5 min. (predose), 0 (end of infusion), and at 10, 20, 30, and 45 min. and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 11, 23, 47, 71, and 95 hrs. after end of infusion|The PK Parameter Analysis Population for ertugliflozin is defined as all participants treated who have at least 1 of the ertugliflozin PK parameters of interest. The PK Parameter Analysis Population for 14^C-ertugliflozin analysis is defined as all participants treated who have at least 1 of the 14^C parameters of interest.||Liters||Geometric Coefficient of Variation|Geometric Mean
639034|NCT02411929|Secondary|Pharmacokinetic Parameter: Apparent Volume of Distribution (Vz/F) Following Oral Administration - Oral, Following Administration of Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ertugliflozin 100 ug IV (Period 1)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose is influenced by the fraction absorbed. Geometric coefficient of variation is given as the percent coefficient of variation. This outcome measure is for the Ertugliflozin oral drug profile only so no participants were analyzed in the 14^C-Ertugliflozin 100 ug intravneous arm.|Oral: 0, 15 and 30 min., and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs. after oral dose; IV: -5 min. (predose), 0 (end of infusion), and at 10, 20, 30, and 45 min. and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 11, 23, 47, 71, and 95 hrs. after end of infusion|The PK Parameter Analysis Population for ertugliflozin is defined as all participants treated who have at least 1 of the ertugliflozin PK parameters of interest. The PK Parameter Analysis Population for 14^C-ertugliflozin analysis is defined as all participants treated who have at least 1 of the 14^C parameters of interest.||Liters||Geometric Coefficient of Variation|Geometric Mean
639035|NCT02411929|Secondary|Pharmacokinetic Parameter: Systemic IV Total Plasma Clearance (CL) - IV, Following Administration of Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ertugliflozin 100 ug IV (Period 1)|Systemic clearance is a calculation of the rate at which a drug is removed from plasma via renal, hepatic and other clearance pathways, expressed as volume (milliliters) per unit of time (minutes). Geometric coefficient of variation is given as the percent coefficient of variation. This outcome measure is for the Ertugliflozin intravenous drug profile only so no participants were analyzed in the Ertugliflozin oral arm.|Oral: 0, 15 and 30 min., and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs. after oral dose; IV: -5 min. (predose), 0 (end of infusion), and at 10, 20, 30, and 45 min. and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 11, 23, 47, 71, and 95 hrs. after end of infusion|The PK Parameter Analysis Population for ertugliflozin is defined as all participants treated who have at least 1 of the ertugliflozin PK parameters of interest. The PK Parameter Analysis Population for 14^C-ertugliflozin analysis is defined as all participants treated who have at least 1 of the 14^C parameters of interest.||mL/min.||Geometric Coefficient of Variation|Geometric Mean
639036|NCT02411929|Secondary|Pharmacokinetic Parameter: Apparent Oral Total Plasma Clearance (CL/F) - Oral, Following Administration of Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ertugliflozin 100 ug IV (Period 1)|Apparent clearance is a calculation of the rate at which a drug is removed from plasma after oral administration via renal, hepatic and other clearance pathways, expressed as volume (milliliters) per unit of time (minutes). Geometric coefficient of variation is given as the percent coefficient of variation. This outcome measure is for the Ertugliflozin oral drug profile only so no participants were analyzed in the 14^C-Ertugliflozin 100 ug IV arm.|Oral: 0, 15 and 30 min., and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs. after oral dose; IV: -5 min. (predose), 0 (end of infusion), and at 10, 20, 30, and 45 min. and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 11, 23, 47, 71, and 95 hrs. after end of infusion|The PK Parameter Analysis Population for ertugliflozin is defined as all participants treated who have at least 1 of the ertugliflozin PK parameters of interest. The PK Parameter Analysis Population for 14^C-ertugliflozin analysis is defined as all participants treated who have at least 1 of the 14^C parameters of interest.||mL/min.||Geometric Coefficient of Variation|Geometric Mean
639037|NCT02411929|Secondary|Pharmacokinetic Parameter: Terminal Elimination Half-Life (t1/2) Following Administration of Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ertugliflozin 100 ug IV (Period 1)|T1/2 is the time required for a given drug concentration in the plasma to decrease by 50%.|Oral: 0, 15 and 30 min., and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs. after oral dose; IV: -5 min. (predose), 0 (end of infusion), and at 10, 20, 30, and 45 min. and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 11, 23, 47, 71, and 95 hrs. after end of infusion|The PK Parameter Analysis Population for ertugliflozin is defined as all participants treated who have at least 1 of the ertugliflozin PK parameters of interest. The PK Parameter Analysis Population for 14^C-ertugliflozin analysis is defined as all participants treated who have at least 1 of the 14^C parameters of interest.||Hours||Standard Deviation|Mean
639038|NCT02411929|Secondary|Pharmacokinetic Parameter: Time for Cmax (Tmax) Following Administration of Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ertugliflozin 100 ug IV (Period 1)|Tmax is a measure of the time to reach the maximum concentration in the plasma after the drug dose. The confidence intervals displayed are minimums to maximums.|Oral: 0, 15 and 30 min., and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs. after oral dose; IV: -5 min. (predose), 0 (end of infusion), and at 10, 20, 30, and 45 min. and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 11, 23, 47, 71, and 95 hrs. after end of infusion|The PK Parameter Analysis Population for ertugliflozin is defined as all participants treated who have at least 1 of the ertugliflozin PK parameters of interest. The PK Parameter Analysis Population for 14^C-ertugliflozin analysis is defined as all participants treated who have at least 1 of the 14^C parameters of interest.||Hours||Full Range|Median
639048|NCT02411539|Secondary|Plasma Levels of sCD14|Not conducted as part of primary analysis and there are no future plans to assess this outcome. Samples were collected for this outcome in order to assess associations with virologic effects observed. Due to the lack of virologic effect observed, the study team has decided that this outcome is no longer of priority/interest and will be abandoned in favor of saving these samples for future research purposes.|Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30|Analysis not performed. See outcome measure description for reasoning.|||||
639039|NCT02411929|Secondary|Pharmacokinetic Parameter: Maximum Plasma Concentration (Cmax) Following Administration of Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ertugliflozin 100 ug IV (Period 1) (Dose Normalized to 1 mg)|Cmax is a measure of the maximum amount of drug in the plasma after the dose is given. Geometric coefficient of variation is given as the percent coefficient of variation.|Oral: 0, 15 and 30 min., and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs. after oral dose; IV: -5 min. (predose), 0 (end of infusion), and at 10, 20, 30, and 45 min. and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 11, 23, 47, 71, and 95 hrs. after end of infusion|The PK Parameter Analysis Population for ertugliflozin is defined as all participants treated who have at least 1 of the ertugliflozin PK parameters of interest. The PK Parameter Analysis Population for 14^C-ertugliflozin analysis is defined as all participants treated who have at least 1 of the 14^C parameters of interest.||ng/mL/mg||Geometric Coefficient of Variation|Geometric Mean
639040|NCT02411929|Secondary|Pharmacokinetic Parameter: (AUC Inf) Following Administration of Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ertugliflozin 100 ug IV (Period 1)|AUC0-inf is a measure of the mean concentration levels of drug in the plasma after the dose. Geometric coefficient of variation is given as the percent coefficient of variation.|Oral: 0, 15 and 30 min., and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs. after oral dose; IV: -5 min. (predose), 0 (end of infusion), and at 10, 20, 30, and 45 min. and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 11, 23, 47, 71, and 95 hrs. after end of infusion|The PK Parameter Analysis Population for ertugliflozin is defined as all participants treated who have at least 1 of the ertugliflozin PK parameters of interest. The PK Parameter Analysis Population for 14^C-ertugliflozin analysis is defined as all participants treated who have at least 1 of the 14^C parameters of interest.||ng•hr/mL||Geometric Coefficient of Variation|Geometric Mean
639041|NCT02411929|Secondary|Area Under the Plasma Concentration-Time Profile From Time Zero to Time of the Last Quantifiable Concentration (AUC Last) Following Administration of Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ert. 100 ug IV (Period 1) (Dose Not Normalized to 1 mg)|AUC0-last is a measure of the total amount of drug in the plasma from time zero to time of the last measurable concentration. Geometric coefficient of variation is given as the percent coefficient of variation.|Oral: 0, 15 and 30 min., and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs. after oral dose; IV: -5 min. (predose), 0 (end of infusion), and at 10, 20, 30, and 45 min. and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 11, 23, 47, 71, and 95 hrs. after end of infusion|The PK Parameter Analysis Population for ertugliflozin is defined as all participants treated who have at least 1 of the ertugliflozin PK parameters of interest. The PK Parameter Analysis Population for 14^C-ertugliflozin analysis is defined as all participants treated who have at least 1 of the 14^C parameters of interest.||ng•hr/mL||Geometric Coefficient of Variation|Geometric Mean
639042|NCT02411929|Primary|Area Under the Plasma Concentration-Time Profile From Time Zero to Time of the Last Quantifiable Concentration (AUC Last) (Dose Normalized to 1 mg) and Absolute Oral Bioavailability (F) (Period 1)|AUC0-inf is a measure of the mean concentration levels of drug in the plasma after the drug dose. An absolute bioavailability provides information on the amount of a drug reaching the systemic circulation and can be determined by comparing the plasma concentration-time-curves (area under the curve) of a compound after oral application of that compound to that after intravenous application of the same compound.|Oral: 0, 15 and 30 min., and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs. after oral dose; IV: -5 min. (predose), 0 (end of infusion), and at 10, 20, 30, and 45 min. and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 11, 23, 47, 71, and 95 hrs. after end of infusion|The pharmacokinetic (PK) Parameter Analysis Population for ertugliflozin is defined as all participants treated who have at least 1 of the ertugliflozin PK parameters of interest. The PK Parameter Analysis Population for 14^C-ertugliflozin analysis is defined as all participants treated who have at least 1 of the 14^C parameters of interest.||AUCinf(dn), ng•hr/mL/mg||Geometric Coefficient of Variation|Geometric Mean
639043|NCT02411747|Primary|Global Rating Scale|The subjects perform a flexible cystoscopy on two different patients and each cystoscopy are being scored by a specialist in Urology (the same in the entire study) using a validated scoring system for flexible cystoscopy, the Global Rating Scale. A previously validated assessment tool, Global Rating Scale (GRS) was used to assess the cystoscopy procedures. GRS is composed of five different parameters: respect for tissue, time and motion, handling of endoscope, flow of procedure, forward planning, and knowledge of procedure. Each parameter is assessed on a five point Likert scale with a minimum of one to maximum of five, giving the total GRS score a range of five to 25. At our institution we have defined a GRS score of three in each parameter (minimum total GRS of 15) as a minimum passing standard.|Two to four weeks after day of simulation training|Two cystoscopies performed on patients by each participant||units on a scale|Participants|Standard Deviation|Mean
639044|NCT02411539|Secondary|Plasma Levels of High-sensitivity C-reactive Protein (hsCRP)|Not conducted as part of primary analysis and there are no future plans to assess this outcome. Samples were collected for this outcome in order to assess associations with virologic effects observed. Due to the lack of virologic effect observed, the study team has decided that this outcome is no longer of priority/interest and will be abandoned in favor of saving these samples for future research purposes.|Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30|Analysis not performed. See outcome measure description for reasoning.|||||
639045|NCT02411539|Secondary|Plasma Levels of Tumor Necrosis Factor Alpha (TNFα)|Not conducted as part of primary analysis and there are no future plans to assess this outcome. Samples were collected for this outcome in order to assess associations with virologic effects observed. Due to the lack of virologic effect observed, the study team has decided that this outcome is no longer of priority/interest and will be abandoned in favor of saving these samples for future research purposes.|Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30|Analysis not performed. See outcome measure description for reasoning.|||||
639046|NCT02411539|Secondary|Plasma Levels of Human Soluble Tumor Necrosis Factor Alpha-receptor (sTNFαR)|Not conducted as part of primary analysis and there are no future plans to assess this outcome. Samples were collected for this outcome in order to assess associations with virologic effects observed. Due to the lack of virologic effect observed, the study team has decided that this outcome is no longer of priority/interest and will be abandoned in favor of saving these samples for future research purposes.|Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30|Analysis not performed. See outcome measure description for reasoning.|||||
639115|NCT02406937|Secondary|Milk Feeding Quantity|Questionnaire recorded by parents. Average quantity of milk feeding per day during the measurement week.|Baseline, Week 4, Week 8, Week 12|||ml/day||Standard Deviation|Mean
639049|NCT02411539|Secondary|Plasma Levels of sCD163|Not conducted as part of primary analysis and there are no future plans to assess this outcome. Samples were collected for this outcome in order to assess associations with virologic effects observed. Due to the lack of virologic effect observed, the study team has decided that this outcome is no longer of priority/interest and will be abandoned in favor of saving these samples for future research purposes.|Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30|Analysis not performed. See outcome measure description for reasoning.|||||
639050|NCT02411539|Secondary|Levels of NK Cell Activation|"% NK cells expressing CD69 or CD95
Not conducted as part of primary analysis and there are no future plans to assess this outcome. Samples were collected for this outcome in order to assess associations with virologic effects observed. Due to the lack of virologic effect observed, the study team has decided that this outcome is no longer of priority/interest and will be abandoned in favor of saving these samples for future research purposes."|Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30|Analysis not performed. See outcome measure description for reasoning.|||||
639051|NCT02411539|Secondary|Levels of T-cell Activation|"% CD4+ and CD8+ T-cells co-expressing human leukocyte antigen (HLA)-DR and CD38
Not conducted as part of primary analysis and there are no future plans to assess this outcome. Samples were collected for this outcome in order to assess associations with virologic effects observed. Due to the lack of virologic effect observed, the study team has decided that this outcome is no longer of priority/interest and will be abandoned in favor of saving these samples for future research purposes."|Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30|Analysis not performed. See outcome measure description for reasoning.|||||
639052|NCT02411539|Secondary|Detectability of Antibody to VRC01 as Measured in Serum|Samples for this outcome have recently been mobilized. Results were not available at the time of the primary analysis. Results will be available at a later time and will then be entered into CT.gov|Measured at week 30||10/2017||||
639053|NCT02411539|Secondary|VRC01 Antibody Level|Samples for this outcome have recently been mobilized. Results were not available at the time of the primary analysis. Results will be available at a later time and will then be entered into CT.gov|Measured at entry and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 15, 18 and 30||10/2017||||
639054|NCT02411539|Secondary|Change in Total/Inducible Virus Recovery - Percentage of Total CD4 Yield|As part of the total virus recovery assay, results for %tCD4 yield are generated. The fold change from pre-entry to the week 6 time point was calculated for each arm (week 6 / pre-entry)|Measured at pre-entry, week 6|Includes all participants with available %tCD4 yield results from virus recovery assay at pre-entry and week 6 time points||fold change||Inter-Quartile Range|Median
639055|NCT02411539|Secondary|Change in Total/Inducible Virus Recovery - Stimulated to Unstimulated Cell Fluor Ratio|As part of the total virus recovery assay, results for stimulated and unstimulated cell fluor (light units) are generated. At each time point, the ratio of the stimulated to unstimulated cell fluor was calculated. The fold change of this ratio from pre-entry to the week 6 time point was calculated for each arm (week 6 / pre-entry)|Measured at pre-entry, week 6|Includes all participants with available stimulated/unstimulated cell fluor results from virus recovery assay at pre-entry and week 6 time points||fold change||Inter-Quartile Range|Median
639056|NCT02411539|Secondary|Change in Total/Inducible Virus Recovery - Unstimulated Cell Fluor|As part of the total virus recovery assay, results for unstimulated cell fluor (light units) are generated. The fold change from pre-entry to the week 6 time point was calculated for each arm (week 6 / pre-entry)|Measured at pre-entry, week 6|Includes all participants with available unstimulated cell fluor results from virus recovery assay at pre-entry and week 6 time points||fold change||Inter-Quartile Range|Median
639057|NCT02411539|Secondary|Change in Total/Inducible Virus Recovery - Stimulated Cell Fluor|As part of the total virus recovery assay, results for stimulated cell fluor (light units) are generated. The fold change from pre-entry to the week 6 time point was calculated for each arm (week 6 / pre-entry)|Measured at pre-entry, week 6|Includes all participants with available stimulated cell fluor results from virus recovery assay at pre-entry and week 6 time points||fold change||Inter-Quartile Range|Median
639058|NCT02411539|Secondary|Change in Total/Inducible Virus Recovery - Stimulated to Unstimulated HIV-1 RNA Ratio|As part of the total virus recovery assay, results for stimulated and unstimulated HIV-1 RNA (copies/mL) are generated. At each time point, the ratio of the stimulated to unstimulated HIV-1 RNA was calculated. The fold change of this ratio from pre-entry to the week 6 time point was calculated for each arm (week 6 / pre-entry)|Measured at pre-entry and week 6|Includes all participants with available stimulated/unstimulated HIV-1 RNA results from virus recovery assay||fold change||Inter-Quartile Range|Median
639059|NCT02411539|Secondary|Change in Total/Inducible Virus Recovery - Unstimulated HIV-1 RNA|As part of the total virus recovery assay, results for unstimulated HIV-1 RNA (copies/mL) are generated. The change from the pre-treatment time point to week 6 was assessed as a fold change (week 6 / pre-entry)|Measured at pre-entry, week 6|Includes all participants with available unstimulated HIV-1 RNA results from virus recovery assay at pre-entry and week 6 time points||fold change||Inter-Quartile Range|Median
639060|NCT02411539|Secondary|Change in Total/Inducible Virus Recovery - Stimulated HIV-1 RNA|As part of the total virus recovery assay, results for stimulated HIV-1 RNA (copies/mL) are generated. The change from the pre-treatment time point to week 6 was assessed as a fold change (week 6 / pre-entry)|Measured at pre-entry, week 6|Includes all participants with available stimulated HIV-1 RNA results from virus recovery assay at pre-entry and week 6 time points||fold change||Inter-Quartile Range|Median
639061|NCT02411539|Secondary|Total/Inducible Virus Recovery - Percentage of Total CD4 Yield|As part of the total virus recovery assay, results for %tCD4 yield are generated.|Measured at pre-entry, week 6 and week 12|Includes all participants with available %tCD4 yield results from virus recovery assay||percentage of Total CD4 Yield||Inter-Quartile Range|Median
639062|NCT02411539|Secondary|Total/Inducible Virus Recovery - Stimulated to Unstimulated Cell Fluor Ratio|As part of the total virus recovery assay, results for stimulated and unstimulated cell fluor (light units) are generated. At each time point, the ratio of the stimulated to unstimulated cell fluor was calculated.|Measured at pre-entry, week 6 and week 12|Includes all participants with available stimulated/unstimulated cell fluor results from virus recovery assay||ratio||Inter-Quartile Range|Median
639116|NCT02406937|Secondary|Milk Regurgitation Frequency|Questionnaire recorded by parents. Average daily frequency of milk regurgitation during the measurement week.|Baseline, Week 4, Week 8, Week 12|||Times/day||Standard Deviation|Mean
639064|NCT02411539|Secondary|Total/Inducible Virus Recovery - Stimulated Cell Fluor|As part of the total virus recovery assay, results for stimulated cell fluor (light units) are generated.|Measured at pre-entry, week 6 and week 12|Includes all participants with available stimulated cell fluor results from virus recovery assay||million light units||Inter-Quartile Range|Median
639065|NCT02411539|Secondary|Total/Inducible Virus Recovery - Stimulated to Unstimulated HIV-1 RNA Ratio|As part of the total virus recovery assay, results for stimulated and unstimulated HIV-1 RNA (copies/mL) are generated. At each time point, the ratio of the stimulated to unstimulated HIV-1 RNA was calculated.|Measured at pre-entry, week 6 and week 12|Includes all participants with available stimulated/unstimulated HIV-1 RNA results from virus recovery assay||ratio||Inter-Quartile Range|Median
639066|NCT02411539|Secondary|Total/Inducible Virus Recovery - Unstimulated HIV-1 RNA|As part of the total virus recovery assay, results for unstimulated HIV-1 RNA (copies/mL) are generated|Measured at pre-entry, week 6 and week 12|Includes all participants with available unstimulated HIV-1 RNA results from virus recovery assay||log10 copies/mL||Inter-Quartile Range|Median
639067|NCT02411539|Secondary|Total/Inducible Virus Recovery - Stimulated HIV-1 RNA|As part of the total virus recovery assay, results for stimulated HIV-1 RNA (copies/mL) are generated|Measured at pre-entry, week 6 and week 12|Includes all participants with available stimulated HIV-1 RNA results from virus recovery assay||log10 copies/mL||Inter-Quartile Range|Median
639068|NCT02411539|Secondary|CD8+ T-cell Counts|Baseline measure represents the average of screening and entry results|Measured at screening, entry and weeks 6, 12, 18 and 30|Analysis of all participants with available CD8+ results||cells/mm^3||Inter-Quartile Range|Median
639069|NCT02411539|Secondary|CD4+ T-cell Counts|Baseline measure represents the average of screening and entry results|Measured at screening, entry and weeks 6, 12, 18 and 30|Analysis of all participants with available CD4+ results||cells/mm^3||Inter-Quartile Range|Median
639070|NCT02411539|Secondary|Number of Participants With Plasma HIV-1 RNA by Single Copy Assay (SCA) Below Assay Lower Limit|The analysis of HIV-1 RNA SCA assessed the number of participants below the assay lower limit (1 copy/mL) at each measurement week. Testing priority was given to samples from screening, entry and weeks 3, 6, 9 and 12. Results from other time points will be available at a later time and will then be entered into CT.gov.|Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30|Analysis of participants with available SCA results||Participants|||Count of Participants
639071|NCT02411539|Secondary|Cell-associated HIV-1 RNA/DNA Ratio in Total CD4+ Cells|Testing priority was given to samples from screening, entry and weeks 3, 6, 9 and 12. Results from other time points will be available at a later time and will then be entered into CT.gov. Baseline values are the geometric mean of screening and entry results.|Measured at screening, entry, weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30|Analysis of participants with available cell-associated HIV-1 RNA/DNA ratio||log10 ratio||Inter-Quartile Range|Median
639072|NCT02411539|Secondary|Cell-associated HIV-1 DNA in Total CD4+ Cells|Testing priority was given to samples from screening, entry and weeks 3, 6, 9 and 12. Results from other time points will be available at a later time and will then be entered into CT.gov. Baseline values are the geometric mean of screening and entry results.|Measured at screening, entry, weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30|Analysis of participants with available cell-associated HIV-1 DNA results||log10 copies/million CD4||Inter-Quartile Range|Median
639073|NCT02411539|Secondary|Cell-associated HIV-1 RNA in Total CD4+ Cells|Testing priority was given to samples from screening, entry and weeks 3, 6, 9 and 12. Results from other time points will be available at a later time and will then be entered into CT.gov. Baseline values are the geometric mean of screening and entry results.|Measured at screening, entry, weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30|Analysis of participants with available cell-associated HIV-1 RNA results||log10 copies/million CD4||Inter-Quartile Range|Median
639074|NCT02411539|Secondary|Change in Cell-associated HIV-1 RNA/DNA Ratio in Total CD4+ Cells - Across Arms|Summary of within-participant change across treatment arms from the pre-VRC01 time point to the post-VRC01 time point. For Arm A, the pre-VRC01 time point used was the baseline measure (geometric average of screening and entry results) and the post-VRC01 time point was the week 6 measure. For Arm B, the pre-VRC01 time point used was the week 6 measure and the post-VRC01 time point was the week 12 measure. Change in CA-RNA/DNA ratio was calculated on the log10 scale.|Screening, entry and weeks 6 and 12|Analysis of all participants with available pre- and post-VRC01 cell-associated RNA/DNA ratio results available. Participants from Arm A must have had results at entry and week 6. Participants from Arm B must have had results from week 6 and week 12.||log10 ratio||Inter-Quartile Range|Median
639075|NCT02411539|Secondary|Change in Cell-associated HIV-1 RNA/DNA Ratio in Total CD4+ Cells - Last Value Carried Forward (LVCF)|Change from baseline (geometric average of screening and entry results) to week 6 in cell-associated HIV-1 RNA/DNA ratio in total CD4+ cells, using a last value carried forward approach if week 6 cell-associated HIV-1 RNA/DNA ratio was missing. In the event that the week 6 value was missing, the week 3 value was carried forward to be used. This comparison is the change from the average of screening and entry results to the week 6 value (if available), and if week 6 result was not available, the week 3 value was used instead of the week 6 value.|Screening, entry, week 3 and week 6 (week 3 used as LVCF if necessary)|Analysis of participants with available results for the change in cell-associated HIV-1 RNA/DNA ratio in total CD4+ cells, carrying last available result forward if missing at week 6||log10 ratio||Inter-Quartile Range|Median
639076|NCT02411539|Secondary|Number of Participants With Premature Treatment Discontinuation, for Reasons Related to Study Treatment|Study treatment was taken from entry through week 12 - this outcome assesses the number of participants who permanently and prematurely discontinued study treatment due to reasons related to the study treatment|Measured from study treatment initiation to study treatment discontinuation (study treatment dispensed through week 12)|All participants who received at least one infusion of study treatment||Participants|||Count of Participants
639077|NCT02411539|Primary|Change in Cell-associated HIV-1 RNA/DNA Ratio in Total CD4+ Cells|Change from baseline (geometric average of screening and entry results) to week 6 in log10 transformed cell-associated HIV-1 RNA/DNA ratio in total CD4+ cells|Screening, entry and week 6|Analysis of participants with available results for the change in cell-associated HIV-1 RNA/DNA ratio in total CD4+ cells. All participants received at least one dose of the randomized treatment assigned. No participants received the incorrect treatment.||log10 ratio||Inter-Quartile Range|Median
639117|NCT02406937|Secondary|Chest Circumference||Baseline, Day 28, Day 56, Day 84|||cm||Standard Deviation|Mean
639118|NCT02406937|Secondary|Head Circumference||Baseline, Day 28, Day 56, Day 84|||cm||Standard Deviation|Mean
639078|NCT02411539|Primary|Number of Participants Who Experienced Grade 3 or Greater, Treatment Related, Adverse Event (AE)|"Refer to detailed description in the protocol section.
Includes signs/symptoms, lab toxicities, and/or clinical events that are possibly, probably, or definitely related to study treatment (as judged by the core team, blinded to treatment arm) at any time from the initial dose of VRC01 to end of study follow-up. This analysis was primarily descriptive and no significance testing was performed."|Measured from study treatment initiation to study discontinuation (study duration is 30 weeks)|Includes all available follow-up for all participants||Participants|||Count of Participants
639079|NCT02411292|Primary|Number of Participants With Bleeding Events|Bleeding events requiring alteration in the course of care within 90 days of surgery|90 days|Bleeding events are reported for the 94 who were not discharged prior to the third Enoxaparin dose. Because two bleeding events occurred prior to the drawing of labs, they cannot be classified into low vs. in-range/high enoxaparin levels. Because of this, reporting on bleeding events is reported across the whole study population and not by arm.||Participants|||Count of Participants
639080|NCT02411292|Primary|Number of Participants With Venous Thromboembolism Events|Any symptomatic venous thromboembolism events, including deep venous thrombosis or pulmonary embolus occurring within 90 days of surgery|90 days|Patients with out-of-range levels or missing levels were dropped from relevant analyses. Of the 89 participants who completed the study, 88 had peak steady-state anti-factor Xa levels to be analyzed.||Participants|||Count of Participants
639081|NCT02411201|Secondary|MRI Lesion Visualization at Subject Level|"Lesion visualization was assessed on up to five most representative lesions per subject based on scoring of 3 co-endpoints:
border delineation (based on a 3-point scale where 1=none; 2=moderate and 3=clear and complete)
internal morphology (based on a 3-point scale where 1=poorly visible; 2=moderately visible and 3=sufficiently visible)
contrast enhancement (based on a 3-point scale where 1=none; 2=weak and 3=clear and bright)
For each co-endpoint, a sum of scores was calculated at subject level as follows: sum of scores = score of the lesion 1 (+ score of the lesion 2 + score of the lesion 3 + score of the lesion 4 + score of the lesion 5, when applicable)"|Pre-injection and post-injection (estimated between 5 and 20 minutes after injection)|Lesion visualization was evaluated in 28 subjects who underwent contrast-enhanced MRI for central nervous system indication.||units on a scale||Standard Deviation|Mean
639082|NCT02411201|Secondary|Simulated Plasma Concentration of DOTAREM|Pharmacokinetics interpretation was performed using a pharmacokinetic population modelling approach. DOTAREM concentrations in plasma were analyzed using a validated LC-MS/MS method.|at 10 and 20 min post-injection|Among the 45 subjects who received one injection of DOTAREM, all had at least one blood sample available for pharmacokinetics.||µmol/L||Full Range|Median
639083|NCT02411201|Primary|Volume of Distribution of DOTAREM at Steady State|Pharmacokinetics interpretation was performed using a pharmacokinetic population modelling approach. DOTAREM concentrations in plasma were analyzed using a validated LC-MS/MS method. Volume of distribution at steady state was determined from typical and individual DOTAREM concentration-time profiles.|Blood samples were collected during 3 time windows: 15 min to 60 min, 2 hours to 4 hours and 6 hours to 8 hours post-injection|Among the 45 subjects who received one injection of DOTAREM, all had at least one blood sample available for pharmacokinetics.||L/kg||Full Range|Mean
639084|NCT02411201|Primary|Total Clearance of DOTAREM From Plasma|Pharmacokinetics interpretation was performed using a pharmacokinetic population modelling approach. DOTAREM concentrations in plasma were analyzed using a validated LC-MS/MS method. Total clearance was determined from typical and individual DOTAREM concentration-time profiles.|Blood samples were collected during 3 time windows: 15 min to 60 min, 2 hours to 4 hours and 6 hours to 8 hours post-injection|Among the 45 subjects who received one injection of DOTAREM, all had at least one blood sample available for pharmacokinetics.||L/hour per kg||Full Range|Mean
639085|NCT02411201|Primary|Terminal Elimination Half-life of DOTAREM From Plasma|Pharmacokinetics interpretation was performed using a pharmacokinetic population modelling approach. DOTAREM concentrations in plasma were analyzed using a validated LC-MS/MS method. Terminal elimination half-life was determined from typical and individual DOTAREM concentration-time profiles.|Blood samples were collected during 3 time windows: 15 min to 60 min, 2 hours to 4 hours and 6 hours to 8 hours post-injection|Among the 45 subjects who received one injection of DOTAREM, all had at least one blood sample available for pharmacokinetics.||hour||Full Range|Mean
639086|NCT02411201|Primary|Rate Constant of the Terminal Phase of DOTAREM|Pharmacokinetics interpretation was performed using a pharmacokinetic population modelling approach. DOTAREM concentrations in plasma were analyzed using a validated LC-MS/MS method. Rate constant of the terminal phase was determined from typical and individual DOTAREM concentration-time profiles.|Blood samples were collected during 3 time windows: 15 min to 60 min, 2 hours to 4 hours and 6 hours to 8 hours post-injection|Among the 45 subjects who received one injection of DOTAREM, all had at least one blood sample available for pharmacokinetics.||hour-1||Full Range|Median
639087|NCT02411201|Primary|Area Under the Curve of DOTAREM in Plasma|Pharmacokinetics interpretation was performed using a pharmacokinetic population modelling approach. DOTAREM concentrations in plasma were analyzed using a validated LC-MS/MS method. Area under the curve was determined from typical and individual DOTAREM concentration-time profiles.|Blood samples were collected during 3 time windows: 15 min to 60 min, 2 hours to 4 hours and 6 hours to 8 hours post-injection|Among the 45 subjects who received one injection of DOTAREM, all had at least one blood sample available for pharmacokinetics.||hour.µmol/L||Full Range|Median
639088|NCT02410824|Secondary|Overall Satisfaction|Overall satisfaction of stenfilcon A and etafilcon A lenses. Scale 0-100, 0=extremely dissatisfied, 100=extremely satisfied.|Baseline and 1 week|||units on a scale||Standard Deviation|Mean
639089|NCT02410824|Secondary|Dryness|Subjective ratings of lens performance for dryness assessed during the day and at the end of the day. Scale 0-100, 0=cannot be worn, extremely dry, 100=no dryness experienced at any time.|1 Week|||units on a scale||Standard Deviation|Mean
639090|NCT02410824|Primary|Lens Fit Acceptance|Lens fit acceptance (on eye stability) for stenfilcon A and etafilcon A assessed at baseline and 1 week. Scale 0-4, 0=Can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.|Baseline and 1 Week|||units on a scale||Standard Deviation|Mean
639091|NCT02410824|Primary|Lens Durability|Lens durability (lens tearing) between stenfilcon A toric lens or etafilcon A toric lens assessed at 1 week. (The number of lens tear or lens nicks found during the one week study).|1 Week|||Lens tear or nick|Lenses||Number
639119|NCT02406937|Secondary|Body Weight||Baseline, Day 28, Day 56, Day 84|||g||Standard Deviation|Mean
639092|NCT02410824|Primary|Conjunctival Staining|"Ocular health of conjunctival staining for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Measured in 0.50 steps, scale 0-4, 0=None, 1=Minimal diffuse punctate, 2=Coalescent punctate, 3=Confluent, 4= Deep confluent
N - Nasal, T - Temporal, S - Superior, I - Inferior"|Baseline and 1 week|||units on a scale||Standard Deviation|Mean
639093|NCT02410824|Primary|Corneal Staining, Extent|Ocular health of corneal staining (extent) for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Scale 0-4, 0=No staining 1=1-15% of area 2=16-30% of area 3=31-45% of area 4=>45% of area Five quadrants: C - Central, N - Nasal, T - Temporal, S - Superior, I - Inferior|Baseline and 1 week|||units on a scale||Standard Deviation|Mean
639094|NCT02410824|Primary|Corneal Staining, Type|Ocular health of corneal staining, type for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Scale 0-4, 0=No staining, 4=Severe staining Five quadrants: C - Central, N - Nasal, T - Temporal, S - Superior, I - Inferior|Baseline and 1 week|||units on a scale||Standard Deviation|Mean
639095|NCT02410824|Primary|Lens Surface - Deposits|Lens surface of wettability for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Scale 0-4, 0=no deposits, 4=severe deposits.|Baseline and 1 Week|||units on a scale||Standard Deviation|Mean
639096|NCT02410824|Primary|Lens Surface - Wettability|Lens surface of wettability for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Scale 0-4, 0=severely reduced, 4=excellent wettability.|Baseline and 1 Week|||units on a scale||Standard Deviation|Mean
639097|NCT02410824|Primary|Low Visual Acuity|Low illumination high contrast (LIHC) visual acuity for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Visual acuity is measured by logMAR.|Baseline and 1 Week|||LogMAR||Standard Deviation|Mean
639098|NCT02410824|Primary|High Visual Acuity|High illumination high contrast (HIHC) visual acuity for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Visual acuity is measured by logMAR.|Baseline and 1 Week|||LogMAR||Standard Deviation|Mean
639099|NCT02410824|Primary|Vision|Subjective ratings of lens performance for vision assessed at baseline and 1 week. Scale 0-100, 0=extremely poor vision all of the time, cannot function, 100=excellent.|Baseline and 1 Week|||units on a scale||Standard Deviation|Mean
639100|NCT02410824|Primary|Handling|Subjective ratings of lens performance for handling assessed at baseline and 1 week. Handling Scale 0-100, 0=very difficult to handle, 100=very easy to handle.|Baseline and 1 Week|||units on a scale||Standard Deviation|Mean
639101|NCT02410824|Primary|Comfort|Subjective ratings of lens performance for comfort assessed at baseline and 1 week. Comfort Scale 0-100, 0=extremely uncomfortable/cannot tolerate, 100=extremely comfortable/cannot be felt.|Baseline and 1 Week|||units on a scale||Standard Deviation|Mean
639102|NCT02410291|Primary|Number of Participants Whom Had Proper Preparation After Education Intervention|patients will receive a questionnaire to assess their satisfaction of their appointment. CT scans will be assessed for compliance of preparation based on departmental guidelines and rescans required.|1 month (patients will be followed until their treatment is complete)|||participants|||Number
639113|NCT02406937|Secondary|Body Mass Index (BMI)|BMI is defined as the body mass divided by the square of the body height, and is universally expressed in units of kg/m^2 (kilogram per square meter).|Baseline, Week 4, Week 8, Week 12|||kg/m^2||Standard Deviation|Mean
639114|NCT02406937|Secondary|Sleeping Time|Questionnaire recorded by parents. Average sleeping time per day during the measurement week.|Baseline, Week 4, Week 8, Week 12|||hours/day||Standard Deviation|Mean
639127|NCT02406937|Secondary|Stool Consistency|"Average Bristol Score during the measurement week. The seven types of stool are:
= Separate hard lumps, like nuts (difficult to pass)
= Sausage-shaped but lumpy
= Like a sausage but with cracks in its surface
= Like a sausage or snake, smooth and soft
= Soft blobs with clear-cut edges (passed easily)
= Fluffy pieces with ragged edges; a mushy stool
= Watery, no solid pieces, entirely liquid Types 1 and 2 indicate constipation, with 3 and 4 being the ideal stools (especially the latter), as they are easy to defecate while not containing excess liquid, and 5, 6 and 7 tending towards diarrhoea."|Baseline, Week 4, Week 8, Week 12|||units on a scale||Standard Deviation|Mean
639128|NCT02406937|Secondary|Number of Participants With Gastrointestinal Symptoms|Number of participants with symptom of bloating and abdominal pain|Weekly (Baseline to Day 84)|||participants|||Number
639129|NCT02406937|Primary|Stool Frequency|Average daily stool frequency during the measurement week|Baseline, Week 4, Week 8, Week 12|||Times per day||Standard Deviation|Mean
639130|NCT02406586|Secondary|Change in Pulse Wave Velocity (PWV)|PWV was measured between the carotid and femoral arteries using the SphygmoCor device. Pressure waveforms at the carotid and femoral arteries were acquired using EKG gating. Velocity (distance per time in milliseconds) was calculated using the foot-to-foot method and the distance between the sites was measured manually.|Baseline, 6 weeks||||||
639131|NCT02406586|Secondary|Change in FFA (Free Fatty Acid) Levels From Baseline to 6 Weeks|Blood samples were collected for measurement of free fatty acids at baseline and 6 weeks after the Intralipid 20% infusion. FFA levels were determined by colorimetric method. Current guidelines identify normal range of FFA level as less than 0.72 mmol/L. Elevated plasma levels of FFA indicate a greater rate of insulin resistance. Change is the difference between 6-week FFA levels from baseline FFA levels.|Baseline, 6 weeks||||||
639132|NCT02406586|Primary|Change in Flow-mediated Dilation|The change in endothelium-dependent vascular reactivity will be measured by flow-mediated dilation (FMD) of the brachial artery using a high-resolution vascular ultrasound with a 10-MHz linear array transducer. FMD is expressed as the percentage increase in diameter at the Week 6 visit from pre-dosing with Intralipid to 24 hours during Intralipid infusion|Pre-dose (Week 6), within 24 hours at Week 6 visit|7 subjects withdrew from the study prior to the Week 6 visit. Data was also not collected for one additional subject.||percent change in diameter||Standard Deviation|Mean
639133|NCT02406586|Primary|Change in Flow-mediated Dilation|The change in endothelium-dependent vascular reactivity will be measured by flow-mediated dilation (FMD) of the brachial artery using a high-resolution vascular ultrasound with a 10-MHz linear array transducer. FMD is expressed as the percentage increase in diameter at the Week 6 visit from pre-dosing with Intralipid to 12 hours during Intralipid infusion.|Pre-dose (Week 6), within 12 hours at Week 6 visit|7 subjects withdrew from the study prior to the Week 6 visit. Data was also not collected for one additional subject.||percent change in diameter||Standard Deviation|Mean
639134|NCT02406586|Primary|Change in Flow-mediated Dilation|The change in endothelium-dependent vascular reactivity will be measured by flow-mediated dilation (FMD) of the brachial artery using a high-resolution vascular ultrasound with a 10-MHz linear array transducer. FMD is expressed as the percentage increase in diameter at the baseline visit from pre-dosing with Intralipid to 24 hours during Intralipid infusion|Pre-dose (Baseline), within 24 hours at Baseline visit|One subject on the salsalate arm withdrew from the study was not included in the baseline analysis population.||percent change in diameter||Standard Deviation|Mean
639135|NCT02406586|Primary|Change in Flow-mediated Dilation|The change in endothelium-dependent vascular reactivity will be measured by flow-mediated dilation (FMD) of the brachial artery using a high-resolution vascular ultrasound with a 10-MHz linear array transducer. FMD is expressed as the percentage increase in diameter at the baseline visit from pre-dosing with Intralipid to 12 hours during Intralipid infusion.|Pre-dose (Baseline), within 12 hours at Baseline visit|One subject in the salsalate arm withdrew from the study was not included in the baseline analysis population.||percent change in diameter||Standard Deviation|Mean
639136|NCT02406586|Primary|Change in Systolic Blood Pressure|Systolic blood pressure is the amount of pressure the heart generates when pumping blood through the arteries to the body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 24-hour infusion with subjects in supine position. Change is the difference in systolic blood pressure at Week 6 from pre-dosing with Intralipid to 24 hours during Intralipid infusion.|Pre-dose (Week 6), within 24 hours at Week 6 visit|7 subjects withdrew from the study prior to the Week 6 visit. Data was also not collected for one additional subject.||mmHg||Standard Deviation|Mean
639137|NCT02406586|Primary|Change in Systolic Blood Pressure|Systolic blood pressure is the amount of pressure the heart generates when pumping blood through the arteries to the body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 24-hour infusion with subjects in supine position. Change is the difference in systolic blood pressure at Week 6 from pre-dosing with Intralipid to 20 hours during Intralipid infusion.|Pre-dose (Week 6), within 20 hours at Week 6 visit|7 subjects withdrew from the study prior to the Week 6 visit. Data was also not collected for one additional subject.||mmHg||Standard Deviation|Mean
639138|NCT02406586|Primary|Change in Systolic Blood Pressure|Systolic blood pressure is the amount of pressure the heart generates when pumping blood through the arteries to the body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 24-hour infusion with subjects in supine position. Change is the difference in systolic blood pressure at Week 6 from pre-dosing with Intralipid to 16 hours during Intralipid infusion.|Pre-dose (Week 6), within 16 hours at Week 6 visit|7 subjects withdrew from the study prior to the Week 6 visit. Data was also not collected for one additional subject.||mmHg||Standard Deviation|Mean
639139|NCT02406586|Primary|Change in Systolic Blood Pressure|Systolic blood pressure is the amount of pressure the heart generates when pumping blood through the arteries to the body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 24-hour infusion with subjects in supine position. Change is the difference in systolic blood pressure at Week 6 from pre-dosing with Intralipid to 12 hours during Intralipid infusion.|Pre-dose (Week 6), within 12 hours at Week 6 visit|7 subjects withdrew from the study prior to the Week 6 visit. Data was also not collected for one additional subject.||mmHg||Standard Deviation|Mean
639140|NCT02406586|Primary|Change in Systolic Blood Pressure|Systolic blood pressure is the amount of pressure the heart generates when pumping blood through the arteries to the body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 24-hour infusion with subjects in supine position. Change is the difference in systolic blood pressure from at Week 6 from pre-dosing with Intralipid to 8 hours during Intralipid infusion.|Pre-dose (Week 6), within 8 hours at Week 6 visit|7 subjects withdrew from the study prior to the Week 6 visit. Data was also not collected for one additional subject.||mmHg||Standard Deviation|Mean
639141|NCT02406586|Primary|Change in Systolic Blood Pressure|Systolic blood pressure is the amount of pressure the heart generates when pumping blood through the arteries to the body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 24-hour infusion with subjects in supine position. Change is the difference in systolic blood pressure at Week 6 from pre-dosing with Intralipid to 4 hours during Intralipid infusion.|Pre-dose (Week 6), within 4 hours at Week 6 visit|7 subjects withdrew from the study prior to the Week 6 visit. Data was also not collected for one additional subject.||mmHg||Standard Deviation|Mean
639142|NCT02406586|Primary|Change in Systolic Blood Pressure|Systolic blood pressure is the amount of pressure the heart generates when pumping blood through the arteries to the body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 24-hour infusion with subjects in supine position. Change is the difference in systolic blood pressure at the baseline visit from pre-dosing with Intralipid to 24 hours during Intralipid infusion.|Pre-dose (Baseline), within 24 hours at Baseline visit|One subject in the salsalate arm withdrew from the study was not included in the baseline analysis population.||mmHg||Standard Deviation|Mean
639143|NCT02406586|Primary|Change in Systolic Blood Pressure|Systolic blood pressure is the amount of pressure the heart generates when pumping blood through the arteries to the body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 24-hour infusion with subjects in supine position. Change is the difference in systolic blood pressure at the baseline visit from pre-dosing with Intralipid to 20 hours during Intralipid infusion.|Pre-dose (Baseline), within 20 hours at Baseline visit|One subject in the salsalate arm withdrew from the study was not included in the baseline analysis population.||mmHg||Standard Deviation|Mean
639144|NCT02406586|Secondary|Change in Expression of Inflammatory Biomarkers (Interleukin-1 (IL-1), Interleukin-6 (IL-6), Interleukin-12 (IL-12), Tumor Necrosis Factor Alpha (TNF-alpha), and C-Reactive Protein (CRP))|IL-1, IL-6, IL-12, TNF-alpha, and CRP are inflammatory biomarkers. Each was measured by using microsphere-based flow cytometric immunoassay. Change is the difference between 6-week inflammatory biomarkers from baseline inflammatory biomarkers.|Baseline, 6 weeks||||||
639145|NCT02406586|Secondary|Change in Augmentation Index (AIx)|AIx is a surrogate measure of peripheral arterial resistance and is measured by analysis of the pulse wave at the radial artery. The AIx is calculated as the ratio of the pulse pressure at the second systolic peak to that at the first systolic peak. Change is the difference between 6-week AIx from baseline AIx.|Baseline, 6 weeks||||||
639146|NCT02406586|Secondary|Change in Oxidative Stress Markers|Oxidative stress was measured by using liquid chromatography to collect plasma glutathione and glutathione disulfide. Change is the difference between 6-week plasma glutathione and glutathione disulfide from baseline plasma glutathione and glutathione disulfide.|Baseline, 6 weeks||||||
639147|NCT02406586|Secondary|Change in Diastolic Blood Pressure From Baseline to 6 Weeks|Diastolic blood pressure is the amount of pressure in the arteries when the heart is at rest between beats. Current guidelines identify normal diastolic blood pressure as lower than 80 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 8 hour infusion with subjects in supine position. Change is the difference between 6-week diastolic blood pressure from baseline diastolic blood pressure.|Baseline, 6 weeks||||||
639148|NCT02406586|Primary|Change in Systolic Blood Pressure|Systolic blood pressure is the amount of pressure the heart generates when pumping blood through the arteries to the body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 24-hour infusion with subjects in supine position. Change is the difference in systolic blood pressure at the baseline visit from pre-dosing with Intralipid to 16 hours during Intralipid infusion.|Pre-dose (Baseline), within 16 hours at Baseline visit|One subject in the salsalate arm withdrew from the study was not included in the baseline analysis population.||mmHg||Standard Deviation|Mean
639149|NCT02406586|Primary|Change in Systolic Blood Pressure|Systolic blood pressure is the amount of pressure the heart generates when pumping blood through the arteries to the body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 24-hour infusion with subjects in supine position. Change is the difference in systolic blood pressure at the baseline visit from pre-dosing with Intralipid to 12 hours during Intralipid infusion.|Pre-dose (Baseline), within 12 hours at Baseline visit|One subject in the salsalate arm withdrew from the study was not included in the baseline analysis population.||mmHg||Standard Deviation|Mean
639150|NCT02406586|Primary|Change in Systolic Blood Pressure|Systolic blood pressure is the amount of pressure the heart generates when pumping blood through the arteries to the body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 24-hour infusion with subjects in supine position. from Change is the difference in systolic blood pressure at the baseline visit from pre-dosing with Intralipid to 8 hours during Intralipid.|Pre-dose (Baseline), within 8 hours at Baseline visit|One subject in the salsalate arm withdrew from the study was not included in the baseline analysis population.||mmHg||Standard Deviation|Mean
639189|NCT02404493|Secondary|Caregiver Questionnaire on Day 14 – Child's Mood Upon Waking in Morning|"Questions were answered after 14 days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Typically, how would you rate your child's mood when he/she wakes up in the morning?"|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
639151|NCT02406586|Primary|Change in Systolic Blood Pressure|Systolic blood pressure is the amount of pressure the heart generates when pumping blood through the arteries to the body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 24-hour infusion with subjects in supine position. Change is the difference in systolic blood pressure at the baseline visit from pre-dosing with Intralipid to 4 hours during Intralipid infusion.|Pre-dose (Baseline), within 4 hours at Baseline visit|One subject in the salsalate arm withdrew from the study was not included in the baseline analysis population.||mmHg||Standard Deviation|Mean
639152|NCT02406495|Secondary|Lens Satisfaction, Overall - Filcon IV 1 and Ocufilcon D|Lens satisfaction overall for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.|Baseline and 1 Week|||percentage of participants|||Number
639153|NCT02406495|Secondary|Lens Satisfaction, Vision - Filcon IV 1 and Ocufilcon D|Lens satisfaction of vision for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.|Baseline and 1 Week|||percentage of participants|||Number
639154|NCT02406495|Secondary|Lens Satisfaction, Handling - Filcon IV 1 and Ocufilcon D|Lens satisfaction of handling forfilcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.|Baseline and 1 Week|||percentage of participants|||Number
639155|NCT02406495|Secondary|Lens Satisfaction, Dryness - Filcon IV 1 and Ocufilcon D|Lens satisfaction of dryness for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.|Baseline and 1 Week|||percentage of participants|||Number
639156|NCT02406495|Secondary|Lens Satisfaction, Comfort - Filcon IV 1 and Ocufilcon D|Lens satisfaction of comfort for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.|Baseline and 1 Week|||percentage of participants|||Number
639157|NCT02406495|Secondary|Lens Preference (Subjective Ratings) - Filcon IV 1 and Ocufilcon D|Subjective ratings of participant's lens preference for either filcon IV 1 or ocufilcon D on comfort, dryness, handling, vision, and overall. Forced choice: filcon IV 1 or ocufilcon D.|1 Week|||percentage of participants|||Number
639158|NCT02406495|Secondary|Vision Satisfaction (Subjective Ratings) - Filcon IV 1 and Ocufilcon D|Subjective ratings of vision satisfaction for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=dissatisfied, 10=very satisfied).|Baseline and 1 Week|||units on a scale||Standard Deviation|Mean
639159|NCT02406495|Secondary|Handling (Subjective Ratings) - Filcon IV 1 and Ocufilcon D|Subjective ratings of handling for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=very difficult to handle, 10=very easy to handle).|Baseline and 1 Week|||units on a scale||Standard Deviation|Mean
639160|NCT02406495|Secondary|Dryness (Subjective Ratings) - Filcon IV 1 and Ocufilcon D|Subjective ratings of dryness for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=dryness, 10=no dryness).|Baseline and 1 Week|||units on a scale||Standard Deviation|Mean
639161|NCT02406495|Primary|Lens Fit, Overall Fit Acceptance - Filcon IV 1 and Ocufilcon D|Lens fit, overall fit acceptance for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 0-4, 0=Should not be worn, 4=Perfect.|Baseline and 1 Week|||percentage of eyes|||Number
639162|NCT02406495|Primary|Lens Fit, Lens Tightness - Filcon IV 1 and Ocufilcon D|"Lens fit, lens tightness for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week.
Scale 0%-100% continuous scale 0% - Falls from cornea without lid support 50% - Optimum 100% - No movement"|Baseline and 1 Week|||percentage of mean lens tightness||Standard Deviation|Mean
639163|NCT02406495|Primary|Lens Fit, Post-blink Movement - Filcon IV 1 and Ocufilcon D|"Lens fit, post-blink movement for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week.
(Scale 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement)."|Baseline and 1 Week|||percentage of eyes|||Number
639164|NCT02406495|Primary|Lens Fit, Centration - Filcon IV 1 and Ocufilcon D|Lens fit, centration for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale: optimum, decentration acceptable, and decentration unacceptable|Baseline and 1 Week|||percentage of eyes|||Number
639165|NCT02406495|Secondary|Comfort (Subjective Ratings) - Filcon IV 1 and Ocufilcon D|Subjective ratings for comfort for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=could feel, 10=cannot feel).|Baseline and 1 Week|||units on a scale||Standard Deviation|Mean
639166|NCT02406495|Secondary|Visual Acuity - Filcon IV 1 and Ocufilcon D|Visual acuity for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week using logMAR chart (a logMAR of 0.0=20/20 in Snellen notation and negative values indicate better visual acuity).|Baseline and 1 Week|||LogMAR||Standard Deviation|Mean
639167|NCT02405429|Primary|Difference Between Rectal and Axillary Temperatures|Rectal temperature minus axillary temperature|Within 2 minutes of each other|Hospitalized neonates||degrees Celsius||Standard Deviation|Mean
639168|NCT02405429|Primary|Difference Between Temporal Artery and Rectal Temperatures|Rectal temperature minus temporal artery temperature|Within 2 minutes of each other|Hospitalized neonates||degrees Celsius||Standard Deviation|Mean
639169|NCT02405429|Primary|Rectal Temperature|With thermistor probe and telethermometer|Single measurement within 2 minutes of temporal artery and axillary temperature measurements|Hospitalized neonates||degrees Celsius||Standard Deviation|Mean
639170|NCT02405429|Primary|Axillary Temperature|With commercial digital thermometer|Single measurement within 2 minutes of temporal artery and rectal temperature measurements|Hospitalized neonates||degrees Celsius||Standard Deviation|Mean
639171|NCT02405429|Primary|Temporal Artery Temperature|With commercial infrared temporal artery thermometer|Mean of 2 measurements within 2 minutes of each other and within 2 minutes of axillary and rectal temperature measurements|Hospitalized neonates||degrees Celsius||Standard Deviation|Mean
639172|NCT02405390|Secondary|Time for Intubation|Time from when the laryngoscope blade enters the mouth until the endotracheal tube enters the vocal cords. No follow up after that.|During the process of intubation (less than one minute)|||second||Standard Deviation|Mean
639173|NCT02405390|Primary|Head Motion - Extension or Flexion|Head motion will only be measured while the patient is being endotracheally intubated. Usually this takes less than one minute. No follow up after that.|During the process of intubation (less than one minute)|||degrees of extension||Standard Deviation|Mean
639177|NCT02404649|Primary|Resonance Frequency Values of Dental Implants|Implant stability quotient (ISQ) is the value on a scale that indicates the level of stability and osseointegration in dental implants. The scale ranges from 1 to 100 and is measured by implant stability meters instruments using resonance frequency analysis (RFA) technique. The acceptable stability range lies between 55-85 ISQ. Lower initial stability will normally increase with time due to the lower mechanical stability being enforced by the bone remodeling process (osseointegration). The overall average ISQ value of all implants over time is approximately 70. A significant decrease in ISQ indicates a potential problem and should be considered an early warning. For each time period three measurements were taken from three different positions on the dental implant and the measurements were averaged for each time period.|8 months|||units on a scale||Standard Deviation|Mean
639178|NCT02404545|Secondary|Number of Participants Who Develop Mesh Related Complications|"Assessed by physical examination including:
Mesh erosion and infection
Stomal stenosis and necrosis
Frequency of stoma pouch appliance changes.
Record by physical exam the incidence of parastomal hernia at 5 years."|60 months|The study required a minimum of 13 participants enrolled per arm for analysis of this outcome measure. Due to the manufacturer's (Ethicon) termination of the Physiomesh device, the study was prematurely terminated with fewer than minimum number of participants required on each arm, and the data were not analyzed.|||||
639179|NCT02404545|Primary|Rate of Reduction of the Incidence of Parastomal Hernia|Rate of reduction of the incidence of parastomal hernia in study participants, as assessed by physical examination|18 months|The study required a minimum of 13 participants enrolled per arm for analysis of this outcome measure. Due to the manufacturer's (Ethicon) termination of the Physiomesh device, the study was prematurely terminated with fewer than minimum number of participants required on each arm, and the data were not analyzed.|||||
639180|NCT02404493|Secondary|Caregiver Questionnaire on Day 14 – Recommend Product|"Questions were answered after 14 days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is I would recommend this product to another parent."|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
639181|NCT02404493|Secondary|Caregiver Questionnaire on Day 14 – How Productive Caregiver Felt Over Past Week|"Questions were answered after 14 days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Over this past week, how productive have you been at work?"|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
639182|NCT02404493|Secondary|Caregiver Questionnaire on Day 14 – How Alert Caregiver Felt Over Past Week|"Questions were answered after 14 days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Over this past week, how alert have you felt?"|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
639183|NCT02404493|Secondary|Caregiver Questionnaire on Day 14 – How Rested Caregiver Felt Over Past Week|"Questions were answered after 14 days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Over this past week, how rested have you felt?"|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
639184|NCT02404493|Secondary|Caregiver Questionnaire on Day 14 – Caregiver Energy Levels Over Past Week|"Questions were answered after 14 days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Over this past week, how much energy have you had to engage with your family?"|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
639185|NCT02404493|Secondary|Caregiver Questionnaire on Day 14 – Amount of Time Caregiver Awake|"Questions were answered after 14 days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is If you did wake up during the night, how much time were you awake (on average) before falling back asleep?"|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||hours||Standard Deviation|Mean
639186|NCT02404493|Secondary|Caregiver Questionnaire on Day 14 – Number of Times Caregiver Woke Up|"Questions were answered after 14 days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is How many times did you wake up during the night?"|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||number of times||Standard Deviation|Mean
639187|NCT02404493|Secondary|Caregiver Questionnaire on Day 14 – Amount of Sleep Caregiver Got Over Past Week|"Questions were answered after 14 days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Over this past week, how much sleep did you get at night?"|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||hours||Standard Deviation|Mean
639188|NCT02404493|Secondary|Caregiver Questionnaire on Day 14 – Child Wanted to Play Over Past Week|"Questions were answered after 14 days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Over this past week, how much has your child wanted to play?"|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
639428|NCT02395055|Primary|Area Under the Plasma Concentration-time Curve From Zero (0) to Time Infinity||0, 6, 24, 48, 72, 96, 120, 144, 168, 192, 336, 672, 1008, 1440, 1680 hours post-dose|All patients who received adalimumab injection.||(ng/ml)*hour||Inter-Quartile Range|Median
639190|NCT02404493|Secondary|Caregiver Questionnaire on Day 14 – Child's Mood Over Past Week|"Questions were answered after 14 days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Over this past week, what has your child's mood been?"|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
639191|NCT02404493|Secondary|Caregiver Questionnaire on Day 14 – Baby’s Skin Feels Soft in Areas Affected by Eczema|"Questions were answered after 14 days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is In the areas affected by eczema, my baby's skin feels soft."|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
639192|NCT02404493|Secondary|Caregiver Questionnaire on Day 14 – Baby’s Skin Looks Healthy in Areas Affected by Eczema|"Questions were answered after 14 days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is In the areas affected by eczema, my baby's skin looks healthy."|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
639193|NCT02404493|Secondary|Caregiver Questionnaire on Day 14 – Baby’s Skin Looks Smooth in Areas Affected by Eczema|"Questions were answered after 14 days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is In the areas affected by eczema, my baby's skin looks smooth."|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
639194|NCT02404493|Secondary|Caregiver Questionnaire on Day 14 – Skin Feels Soft Overall|"Questions were answered after 14 days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Overall, my baby's skin feels soft."|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
639195|NCT02404493|Secondary|Caregiver Questionnaire on Day 14 – Skin Looks Healthy Overall|"Questions were answered after 14 days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Overall, my baby's skin looks healthy."|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
639196|NCT02404493|Secondary|Caregiver Questionnaire on Day 14 – Skin Looks Smooth Overall|"Questions were answered after 14 days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Overall, my baby's skin looks smooth."|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
639197|NCT02404493|Secondary|Caregiver Questionnaire on Day 7 – How Productive Caregiver Felt Over Past Week|"Questions were answered after seven days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Over this past week, how productive have you been at work?"|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
639198|NCT02404493|Secondary|Caregiver Questionnaire on Day 7 – How Alert Caregiver Felt Over Past Week|"Questions were answered after seven days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Over this past week, how alert have you felt?"|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
639199|NCT02404493|Secondary|Caregiver Questionnaire on Day 7 – How Rested Caregiver Felt Over Past Week|"Questions were answered after seven days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Over this past week, how rested have you felt?"|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
639200|NCT02404493|Secondary|Caregiver Questionnaire on Day 7 – Caregiver Energy Levels Over Past Week|"Questions were answered after seven days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Over this past week, how much energy have you had to engage with your family?"|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
639201|NCT02404493|Secondary|Caregiver Questionnaire on Day 7 – Amount of Time Caregiver Awake|"Questions were answered after seven days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is If you did wake up during the night, how much time were you awake (on average) before falling back asleep?"|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||hours||Standard Deviation|Mean
639202|NCT02404493|Secondary|Caregiver Questionnaire on Day 7 – Number of Times Caregiver Woke Up|"Questions were answered after seven days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is How many times did you wake up during the night?"|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||number of times||Standard Deviation|Mean
639203|NCT02404493|Secondary|Caregiver Questionnaire on Day 7 – Amount of Sleep Caregiver Got Over Past Week|"Questions were answered after seven days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Over this past week, how much sleep did you get at night?"|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||hours||Standard Deviation|Mean
639204|NCT02404493|Secondary|Caregiver Questionnaire on Day 7 – Child Wanted to Play Over Past Week|"Questions were answered after seven days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Over this past week, how much has your child wanted to play?"|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
639205|NCT02404493|Secondary|Caregiver Questionnaire on Day 7 – Child's Mood Upon Waking in Morning|"Questions were answered after seven days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Typically, how would you rate your child's mood when he/she wakes up in the morning?"|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
639206|NCT02404493|Secondary|Caregiver Questionnaire on Day 7 – Child's Mood Over Past Week|"Questions were answered after seven days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Over this past week, what has your child's mood been?"|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
639207|NCT02404493|Secondary|Caregiver Questionnaire on Day 7 – Baby’s Skin Feels Soft in Areas Affected by Eczema|"Questions were answered after seven days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is In the areas affected by eczema, my baby's skin feels soft."|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
639208|NCT02404493|Secondary|Caregiver Questionnaire on Day 7 – Baby’s Skin Looks Healthy in Areas Affected by Eczema|"Questions were answered after seven days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is In the areas affected by eczema, my baby's skin looks healthy."|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
639209|NCT02404493|Secondary|Caregiver Questionnaire on Day 7 – Baby’s Skin Looks Smooth in Areas Affected by Eczema|"Questions were answered after seven days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is In the areas affected by eczema, my baby's skin looks smooth."|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
639210|NCT02404493|Secondary|Caregiver Questionnaire on Day 7 – Skin Feels Soft Overall|"Questions were answered after seven days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Overall, my baby's skin feels soft."|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
639211|NCT02404493|Secondary|Caregiver Questionnaire on Day 7 – Skin Looks Healthy Overall|"Questions were answered after seven days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Overall, my baby's skin looks healthy."|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
639212|NCT02404493|Secondary|Caregiver Questionnaire on Day 7 – Skin Looks Smooth Overall|"Questions were answered after seven days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Overall, my baby's skin looks smooth."|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
639213|NCT02404493|Secondary|Caregiver Questionnaire on Day 3 – Baby’s Skin Feels Soft in Areas Affected by Eczema|"Questions were answered after three days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is In the areas affected by eczema, my baby's skin feels soft."|3 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
639214|NCT02404493|Secondary|Caregiver Questionnaire on Day 3 – Baby’s Skin Looks Healthy in Areas Affected by Eczema|"Questions were answered after three days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is In the areas affected by eczema, my baby's skin looks healthy."|3 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
639215|NCT02404493|Secondary|Caregiver Questionnaire on Day 3 – Baby’s Skin Looks Smooth in Areas Affected by Eczema|"Questions were answered after three days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is In the areas affected by eczema, my baby's skin looks smooth."|3 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
639216|NCT02404493|Secondary|Caregiver Questionnaire on Day 3 – Skin Feels Soft Overall|"Questions were answered after three days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Overall, my baby's skin feels soft."|3 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
639217|NCT02404493|Secondary|Caregiver Questionnaire on Day 3 – Skin Looks Healthy Overall|"Questions were answered after three days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Overall, my baby's skin looks healthy."|3 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
639218|NCT02404493|Secondary|Caregiver Questionnaire on Day 3 – Skin Looks Smooth Overall|"Questions were answered after three days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Overall, my baby's skin looks smooth."|3 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
639219|NCT02404493|Secondary|Caregiver Questionnaire on Day 0 Post-treatment – Baby’s Skin Feels Soft in Areas Affected by Eczema|"Questions were answered after treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is In the areas affected by eczema, my baby's skin feels soft."|0 Days - Post-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
639220|NCT02404493|Secondary|Caregiver Questionnaire on Day 0 Post-treatment – Baby’s Skin Looks Healthy in Areas Affected by Eczema|"Questions were answered after treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is In the areas affected by eczema, my baby's skin looks healthy."|0 Days - Post-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
639221|NCT02404493|Secondary|Caregiver Questionnaire on Day 0 Post-treatment – Baby’s Skin Looks Smooth in Areas Affected by Eczema|"Questions were answered after treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is In the areas affected by eczema, my baby's skin looks smooth."|0 Days - Post-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
639222|NCT02404493|Secondary|Caregiver Questionnaire on Day 0 Post-treatment – Skin Feels Soft Overall|"Questions were answered after treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Overall, my baby's skin feels soft."|0 Days - Post-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
639223|NCT02404493|Secondary|Caregiver Questionnaire on Day 0 Post-treatment – Skin Looks Healthy Overall|"Questions were answered after treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Overall, my baby's skin looks healthy."|0 Days - Post-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
639224|NCT02404493|Secondary|Caregiver Questionnaire on Day 0 Post-treatment – Skin Looks Smooth Overall|"Questions were answered after treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Overall, my baby's skin looks smooth."|0 Days - Post-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
639225|NCT02404493|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment – How Productive Caregiver Felt Over Past Week|"Questions were answered before treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Over this past week, how productive have you been at work?"|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
639226|NCT02404493|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment – How Alert Caregiver Felt Over Past Week|"Questions were answered before treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Over this past week, how alert have you felt?"|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
639227|NCT02404493|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment – How Rested Caregiver Felt Over Past Week|"Questions were answered before treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Over this past week, how rested have you felt?"|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
639228|NCT02404493|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment – Caregiver Energy Levels Over Past Week|"Questions were answered before treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Over this past week, how much energy have you had to engage with your family?"|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
639229|NCT02404493|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment – Amount of Time Caregiver Awake|"Questions were answered before treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is If you did wake up during the night, how much time were you awake (on average) before falling back asleep?"|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||hours||Standard Deviation|Mean
639230|NCT02404493|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment – Number of Times Caregiver Woke Up|"Questions were answered before treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is How many times did you wake up during the night?"|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||number of times||Standard Deviation|Mean
639231|NCT02404493|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment – Amount of Sleep Caregiver Got Over Past Week|"Questions were answered before treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Over this past week, how much sleep did you get at night?"|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||hours||Standard Deviation|Mean
639232|NCT02404493|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment – Child Wanted to Play Over Past Week|"Questions were answered before treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Over this past week, how much has your child wanted to play?"|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
639233|NCT02404493|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment – Child's Mood Upon Waking in Morning|"Questions were answered before treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Typically, how would you rate your child's mood when he/she wakes up in the morning?"|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
639234|NCT02404493|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment – Child's Mood Over Past Week|"Questions were answered before treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Over this past week, what has your child's mood been?"|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
639235|NCT02404493|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment – Baby’s Skin Feels Soft in Areas Affected by Eczema|"Questions were answered before treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is In the areas affected by eczema, my baby's skin feels soft."|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
639236|NCT02404493|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment – Baby’s Skin Looks Healthy in Areas Affected by Eczema|"Questions were answered before treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is In the areas affected by eczema, my baby's skin looks healthy."|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
639237|NCT02404493|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment – Baby’s Skin Looks Smooth in Areas Affected by Eczema|"Questions were answered before treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is In the areas affected by eczema, my baby's skin looks smooth."|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
639238|NCT02404493|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment – Skin Feels Soft Overall|"Questions were answered before treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Overall, my baby's skin feels soft."|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
639239|NCT02404493|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment – Skin Looks Healthy Overall|"Questions were answered before treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Overall, my baby's skin looks healthy."|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
639240|NCT02404493|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment – Skin Looks Smooth Overall|"Questions were answered before treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Overall, my baby's skin looks smooth."|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
639279|NCT02404493|Secondary|Caregiver's Itch Assessment on Day 3 - Change From Baseline|An assessment of dryness based on the following scale, 0 (don't have an opinion), 1 (none), 2 (a little), 3 (a lot), 4 (all the time).|Day 0 - Pretreatment (Baseline) to Day 3|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||units on a scale||Standard Deviation|Mean
639241|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Child's Sleep a Problem|Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Do you consider your child's sleep a problem? Caregiver answered based on a 6 point system ranged from 'I don't have an opinion' to 'a serious problem'.|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
639242|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Total Time Child Sleeps During the Day|Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Typically, how much total time does your child spend sleeping during the day?|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||hours||Standard Deviation|Mean
639243|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Number of Naps Child Takes During the Day|Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On a typical day, how many naps does your child take?|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||number of naps||Standard Deviation|Mean
639244|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Total Time Child is Asleep During the Night|Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On average, how much total time does your child spend sleeping during the night?|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||hours||Standard Deviation|Mean
639245|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Longest Time Child is Asleep During the Night|Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On average, what is the longest stretch of time that your child is asleep during the night without waking up?|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||hours||Standard Deviation|Mean
639246|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Total Time Child Awake During the Night|Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How much total time during the night is your child typically awake?|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||minutes||Standard Deviation|Mean
639247|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Number of Times Child Awakes During the Night|Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How many times does your child typically wake during the night?|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||number of times||Standard Deviation|Mean
639248|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Time for Child to Fall Asleep|Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How long does it typically take your child to fall asleep?|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||minutes||Standard Deviation|Mean
639249|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Difficulty of Bedtime|Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Typically, how difficult is bedtime for your child? Caregiver answered based on a 5 point system ranging from 'very easy' to 'very difficult'.|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
639250|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Time Child Usually Put to Bed|Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What time do you usually put your child to bed at night? Time is represented as post meridiem (pm).|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||hours.minutes||Standard Deviation|Mean
639251|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Sleeping Arrangement|Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What is the sleeping arrangement?|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
639252|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Responder Role|Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What is the role of the responder?|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
639253|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Child's Sleep a Problem|Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Do you consider your child's sleep a problem? Caregiver answered based on a 6 point system ranged from 'I don't have an opinion' to 'a serious problem'.|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
639254|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Total Time Child Sleeps During the Day|Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Typically, how much total time does your child spend sleeping during the day?|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||hours||Standard Deviation|Mean
639255|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Number of Naps Child Takes During the Day|Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On a typical day, how many naps does your child take?|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||number of naps||Standard Deviation|Mean
639256|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Total Time Child is Asleep During the Night|Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On average, how much total time does your child spend sleeping during the night?|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||hours||Standard Deviation|Mean
639257|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Longest Time Child is Asleep During the Night|Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On average, what is the longest stretch of time that your child is asleep during the night without waking up?|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||hours||Standard Deviation|Mean
639258|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Total Time Child Awake During the Night|Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How much total time during the night is your child typically awake?|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||minutes||Standard Deviation|Mean
639259|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Number of Times Child Awakes During the Night|Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How many times does your child typically wake during the night?|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||number of times||Standard Deviation|Mean
639260|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Time for Child to Fall Asleep|Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How long does it typically take your child to fall asleep?|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||minutes||Standard Deviation|Mean
639261|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Difficulty of Bedtime|Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Typically, how difficult is bedtime for your child? Caregiver answered based on a 5 point system ranging from 'very easy' to 'very difficult'.|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
639262|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Time Child Usually Put to Bed|Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What time do you usually put your child to bed at night? Time is represented as post meridiem (pm).|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||hours.minutes||Standard Deviation|Mean
639263|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 7- Sleeping Arrangement|Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What is the sleeping arrangement?|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
639264|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Responder Role|Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What is the role of the responder?|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
639265|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Child's Sleep a Problem|Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Do you consider your child's sleep a problem? Caregiver answered based on a 6 point system ranged from 'I don't have an opinion' to 'a serious problem'.|0 Days Pretreatment (Baseline)|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
639280|NCT02404493|Secondary|Dryness Scale Score on Day 14 - Change From Baseline|An assessment of dryness based on a 4 point scale, ranging from 0 (none) to 4 (severe dryness).|Day 0 - Pretreatment (Baseline) to Day 14|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||units on a scale||Standard Deviation|Mean
641660|NCT02299869|Primary|Comfort|Participant's subjective rating for comfort. (Scale 0-10, 0=poor, 10=excellent).|20 minutes|||units on a scale||Standard Deviation|Mean
639266|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Total Time Child Sleeps During the Day|Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Typically, how much total time does your child spend sleeping during the day?|0 Days Pretreatment (Baseline)|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||hours||Standard Deviation|Mean
639267|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Number of Naps Child Takes During the Day|Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On a typical day, how many naps does your child take?|0 Days Pretreatment (Baseline)|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||number of naps||Standard Deviation|Mean
639268|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Total Time Child is Asleep During the Night|Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On average, how much total time does your child spend sleeping during the night?|0 Days Pretreatment (Baseline)|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||hours||Standard Deviation|Mean
639269|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Longest Time Child is Asleep During the Night|Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On average, what is the longest stretch of time that your child is asleep during the night without waking up?|0 Days Pretreatment (Baseline)|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||hours||Standard Deviation|Mean
639270|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Total Time Child Awake During the Night|Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How much total time during the night is your child typically awake?|0 Days Pretreatment (Baseline)|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||minutes||Standard Deviation|Mean
639271|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Number of Times Child Awakes During the Night|Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How many times does your child typically wake during the night?|0 Days Pretreatment (Baseline)|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||number of times||Standard Deviation|Mean
639272|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Time for Child to Fall Asleep|Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How long does it typically take your child to fall asleep?|0 Days Pretreatment (Baseline)|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||minutes||Standard Deviation|Mean
639273|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Difficulty of Bedtime|Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Typically, how difficult is bedtime for your child? Caregiver answered based on a 5 point system ranging from 'very easy' to 'very difficult'.|0 Days Pretreatment (Baseline)|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
639274|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Time Child Usually Put to Bed|Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What time do you usually put your child to bed at night? Time is represented as post meridiem (pm).|0 Days Pretreatment (Baseline)|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||hours.minutes||Standard Deviation|Mean
639275|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Sleeping Arrangement|Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What is the sleeping arrangement?|0 Days Pretreatment (Baseline)|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
639276|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Responder Role|Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What is the role of the responder?|0 Days Pretreatment (Baseline)|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||percentage of participants|||Number
639277|NCT02404493|Secondary|Caregiver's Itch Assessment on Day 14 - Change From Baseline|An assessment of dryness based on the following scale, 0 (don't have an opinion), 1 (none), 2 (a little), 3 (a lot), 4 (all the time).|Day 0 - Pretreatment (Baseline) to Day 14|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||units on a scale||Standard Deviation|Mean
639278|NCT02404493|Secondary|Caregiver's Itch Assessment on Day 7 - Change From Baseline|An assessment of dryness based on the following scale, 0 (don't have an opinion), 1 (none), 2 (a little), 3 (a lot), 4 (all the time).|Day 0 - Pretreatment (Baseline) to Day 7|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||units on a scale||Standard Deviation|Mean
639281|NCT02404493|Secondary|Dryness Scale Score on Day 7 - Change From Baseline|An assessment of dryness based on a 4 point scale, ranging from 0 (none) to 4 (severe dryness).|Day 0 - Pretreatment (Baseline) to Day 7|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||units on a scale||Standard Deviation|Mean
639282|NCT02404493|Secondary|Dryness Scale Score on Day 3 - Change From Baseline|An assessment of dryness based on a 4 point scale, ranging from 0 (none) to 4 (severe dryness).|Day 0 - Pretreatment (Baseline) to Day 3|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||units on a scale||Standard Deviation|Mean
639283|NCT02404493|Secondary|Dryness Scale Score on Day 1 - Change From Baseline|An assessment of dryness based on a 4 point scale, ranging from 0 (none) to 4 (severe dryness).|Day 0 - Pretreatment (Baseline) to Day 1|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||units on a scale||Standard Deviation|Mean
639284|NCT02404493|Secondary|Investigator’s Global Atopic Dermatitis Assessment (IGADA) on Day 14 - Change From Baseline|The signs and symptoms of eczema are measured using the Investigator’s Global Atopic Dermatitis Assessment (IGADA). An assessment of atopic dermatitis based on a 4 point scale, ranging from 0 (absent) to 3 (severe), is used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating is categorized as clear, almost clear, mild, moderate, severe, or very severe.|Day 0 - Pretreatment (Baseline) to Day 14|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||units on a scale||Standard Deviation|Mean
639285|NCT02404493|Secondary|Investigator’s Global Atopic Dermatitis Assessment (IGADA) on Day 7 - Change From Baseline|The signs and symptoms of eczema are measured using the Investigator’s Global Atopic Dermatitis Assessment (IGADA). An assessment of atopic dermatitis based on a 4 point scale, ranging from 0 (absent) to 3 (severe), is used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating is categorized as clear, almost clear, mild, moderate, severe, or very severe.|Day 0 - Pretreatment (Baseline) to Day 7|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||units on a scale||Standard Deviation|Mean
639286|NCT02404493|Secondary|Investigator’s Global Atopic Dermatitis Assessment (IGADA) on Day 3 - Change From Baseline|The signs and symptoms of eczema are measured using the Investigator’s Global Atopic Dermatitis Assessment (IGADA). An assessment of atopic dermatitis based on a 4 point scale, ranging from 0 (absent) to 3 (severe), is used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating is categorized as clear, almost clear, mild, moderate, severe, or very severe.|Day 0 - Pretreatment (Baseline) to Day 3|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||units on a scale||Standard Deviation|Mean
639287|NCT02404493|Secondary|Investigator’s Global Atopic Dermatitis Assessment (IGADA) on Day 1 - Change From Baseline|The signs and symptoms of eczema are measured using the Investigator’s Global Atopic Dermatitis Assessment (IGADA). An assessment of atopic dermatitis based on a 4 point scale, ranging from 0 (absent) to 3 (severe), is used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating is categorized as clear, almost clear, mild, moderate, severe, or very severe.|Day 0 - Pretreatment (Baseline) to Day 1|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||units on a scale||Standard Deviation|Mean
639288|NCT02404493|Secondary|Eczema Area and Severity Index (EASI) on Day 14 - Change From Baseline|The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (absent) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72.|Day 0 - Pretreatment (Baseline) to Day 14|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||units on a scale||Standard Deviation|Mean
639289|NCT02404493|Secondary|Eczema Area and Severity Index (EASI) on Day 7 - Change From Baseline|The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (absent) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72.|Day 0 - Pretreatment (Baseline) to Day 7|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||units on a scale||Standard Deviation|Mean
639290|NCT02404493|Secondary|Eczema Area and Severity Index (EASI) on Day 3 - Change From Baseline|The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (absent) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72.|Day 0 - Pretreatment (Baseline) to Day 3|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||units on a scale||Standard Deviation|Mean
639291|NCT02404493|Secondary|Eczema Area and Severity Index (EASI) on Day 1 - Change From Baseline|The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (absent) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72.|Day 0 - Pretreatment (Baseline) to Day 1|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||units on a scale||Standard Deviation|Mean
639292|NCT02404493|Secondary|Change From Baseline in Mean Corneometer Measurement 14 Days After Treatment|Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.|Day 0 - Pretreatment (Baseline) to 14 Days After treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||arbitrary units||Standard Deviation|Mean
639350|NCT02400996|Primary|Nonfunctioning and Malignant Pancreatic Endocrine Neoplasms|Of the 40 patients operated for Pancreatic Endocrine Neoplasms, using clinical criteria, histopathological analysis and preoperative imaging as gold standard, nonfunctioning and functioning tumours were identified. Similarly the number of benign and malignant lesions identified were recorded as per the WHO Classification of pancreatic endocrine tumours.|Each participant was followed up for a period of 5 years|||participants|||Number
639293|NCT02404493|Secondary|Change From Baseline in Mean Corneometer Measurement 7 Days After Treatment|Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.|Day 0 - Pretreatment (Baseline) to 7 Days After treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||arbitrary units||Standard Deviation|Mean
639294|NCT02404493|Secondary|Change From Baseline in Mean Corneometer Measurement 3 Days After Treatment|Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.|Day 0 - Pretreatment (Baseline) to 3 Days After treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||arbitrary units||Standard Deviation|Mean
639295|NCT02404493|Secondary|Change From Baseline in Mean Corneometer Measurement 24 Hours After Treatment|Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.|Day 0 - Pretreatment (Baseline) to 24 Hours After treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||arbitrary units||Standard Deviation|Mean
639296|NCT02404493|Primary|Change From Baseline in Mean Corneometer Measurement 12 Hours After Treatment|Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.|Day 0 - Pretreatment (Baseline) to 12 Hours After treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||arbitrary units||Standard Deviation|Mean
639297|NCT02404493|Primary|Change From Baseline in Mean Corneometer Measurement Immediately Following Treatment|Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.|Day 0 - Pretreatment (Baseline) to Day 0 - immediately post treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||arbitrary units||Standard Deviation|Mean
639298|NCT02403830|Secondary|AUC of Ticagrelor Plasma Levels|The area under the plasma concentration vs. time curve from time 0 to the last measurable concentration (AUC) was calculated based on ticagrelor plasma levels|6 hours|||ng*hr/mL||Full Range|Geometric Mean
639299|NCT02403830|Secondary|Platelet Reactivity Measured by VASP|Platelet reactivity measured by VASP 2 hours after ticagrelor loading dose and reported as platelet reactivity index (PRI)|2 hours|||PRI||95% Confidence Interval|Least Squares Mean
639300|NCT02403830|Primary|Platelet Reactivity Measured by VerifyNow P2Y12|Platelet reactivity measured by VerifyNow P2Y12 2 hours after ticagrelor loading dose and reported as P2Y12 reaction units (PRU)|2 hours|||PRU||95% Confidence Interval|Least Squares Mean
639301|NCT02403206|Secondary|Operating Time in the Eye to Complete Entire Cataract Procedure|Operating time in the eye was the time interval (in seconds) from the time the corneal incision was opened to the time the wound was closed. Only one eye (study eye) contributed to the analysis.|Day 0 (operative day)|Intent-to-Treat Analysis Set||seconds||Standard Deviation|Mean
639302|NCT02403206|Primary|Percentage of Capsular Tears (Anterior or Posterior) During Surgery|A capsular tear is defined as any unintended tear on the anterior or posterior capsule and includes a radial tear that moves peripherally on the anterior capsule during capsulotomy and extends to form a posterior capsular tear during intumescent cataract surgery. An intumescent cataract is defined as a cataract with a pressurized capsular bag. A lower value indicates fewer capsular tears. Only one eye (study eye) contributed to the analysis.|Day 0 (operative day)|Intent-to-Treat Analysis Set||percentage of capsular tears|||Number
639303|NCT02403180|Secondary|Mean Area of Focus Under the Mean Defocus Curve After 5 +/- 1 Days of Contact Lens Wear|Visual acuity was measured with contact lenses in place using an Early Treatment Diabetic Retinopathy Study (ETDRS) high contrast logMAR chart under well-lit conditions. Trial Lenses of different spherical powers (+2.00 diopter to -5.00 diopter) were placed in front of the eyes to produce varying levels of defocus, and logMAR acuity at each defocus value was recorded. The area under the defocus curve (AUC) was calculated via the trapezoidal rule for the entire study population by treatment using a 0.3 logMAR threshold for intermediate from -2.00 D (50cm) to -0.50 D (2m) and near from -4.00 D (25cm) to -2.00 D (50cm). A higher value indicates a bigger area of focus.|Day 5, each product|Intention to treat participants with non-missing observations||diopter*logMar||Standard Deviation|Mean
639304|NCT02403180|Primary|Mean Stereoacuity at Near After 5+/-1 Days of Contact Lens Wear|Stereoacuity (SA) is the ability to detect differences in distance (depth perception). Near SA was measured at a distance of 40 cm using the Howard-Dolman system. A lower SA value indicates better depth perception.|Day 5, each product|Intention to treat participants with non-missing observations||arcsec||Standard Deviation|Mean
639305|NCT02402933|Secondary|Change in Blood Glucose Level Over Time|Glucometer-based measurements of blood glucose after the studied drug administration. The participants’ change in blood glucose level from baseline was measured by the caregiver using a glucometer at 15, 30 and 45 minutes after IN glucagon administration.|Baseline, 15, 30 and 45 minutes after drug administration for an episode of hypoglycemia|All participants for efficacy and safety analysis experiencing at least one hypoglycemic event. Proportions based on the total number of hypoglycemic events (N=33) from 14 participants. Participants from the non-GCP compliant site were excluded from efficacy and safety analysis.||milligram/deciliter (mg/dL)||Standard Deviation|Mean
639306|NCT02402933|Secondary|Percentage of Participants With Adverse Events Through Questionnaires|An adverse event is a clinical event is a health change from the participant’s normal state, as defined during the pre-trial evaluation and enrollment. Adverse events were assessed based on the Nasal Score Questionnaire and the Hypoglycemia Questionnaire.|Within 2 hours of full recovery from a hypoglycemic event|All participants for efficacy and safety analysis experiencing at least one hypoglycemic event. Proportions based on the total number of participants (N=14). Participants from the non-GCP compliant site were excluded from the analysis.||percentage of participants|||Number
639307|NCT02402933|Secondary|Assessment of Ease-of-use of Dry-Mist Nasal Glucagon by Completion of Questionnaires by the Caregiver|"Assess ease-of-use of intranasally administered glucagon in the hands of caregivers of participants who may be called upon to treat episodes of hypoglycemia.
Measurement for Degree of difficulty: opening the kit, Degree of difficulty: understanding the instructions on how to use the kit, Degree of difficulty: administering the medication into the nostril, Degree of satisfaction is 1 (Very Difficult) to 7 (Very Easy). Measurement for Dry Mist Nasal Glucagon will be easy to teach other caregivers, Nasal formulation of glucagon is less intimidating for caregivers, Dry Mist Nasal Glucagon is easy to carry and would be willing to carry it, Intranasal delivery of glucagon is preferable: level of agreement 1 (Strongly Disagree) to 7 (Strongly Agree)."|After each drug administration for an episode of hypoglycemia|All participants for efficacy and safety analysis experiencing at least one hypoglycemic event. Proportions and n are based on the total number of hypoglycemic events (N=33) of 14 participants; except compare of administration are based on 8 events. Participants from the non-GCP compliant site were excluded from efficacy and safety analysis.||percentage of event|||Number
639308|NCT02402933|Primary|Number of Participants Awakening or Returning to a Normal Status Within 30 Minutes Following Studied Drug of Administration|"Number of participants with effectiveness of nasal glucagon administered under clinical use in treating episodes of hypoglycemia in children and adolescents with Type 1 Diabetes (T1D), as defined by clinical recovery following studied drug administration. Responses to questions completed by the caregiver are used to assess this outcome.
An episode of severe hypoglycemia is generally defined as an event associated with severe neuroglycopenia usually resulting in coma or seizure and requiring parenteral therapy (glucagon or intravenous glucose) administered by a third party. In this study moderate hypoglycemia is defined as an episode wherein the child/adolescent with diabetes has symptoms and/or signs of neuroglycopenia and has a blood glucose ≤3.9 millimole per liter (mmol/L) (70 milligram per deciliter [mg/dL]) based on a blood sample taken at or close to the time of treatment."|Within 30 minutes after each drug administration for an episode of hypoglycemia|All participants for efficacy analysis experiencing at least one hypoglycemic event. Proportions based on the total number of participants who had available hypoglycemic events (N=33). Participants from the non-Good Clinical Practice (GCP) compliant site were excluded from efficacy and safety analysis.||participants|||Number
639309|NCT02402764|Secondary|Overall Survival (OS)|Overall survival, defined as the time from randomization to death from any cause.|End of post-treatment 12 month follow-up, up to 24 months per participant|All participants||months||95% Confidence Interval|Median
639310|NCT02402764|Secondary|Progression-Free Survival (PFS)|Median time to progression. Progression-free survival is defined as time elapsed from the beginning of study treatment to the first documentation of radiologic progression as defined by standard RECIST criteria or death.|Up to 10 months|All participants||months||95% Confidence Interval|Median
639311|NCT02402764|Secondary|Duration of Overall Response|The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started) or death. The duration of overall CR is measured from the time measurement criteria are first met for CR until the first date that recurrent disease is objectively documented or death.|Up to 10 months|Participants with Complete Response or Partial Response|||||
639312|NCT02402764|Secondary|Best Overall Response (OR)|The best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The patient's best response assignment will depend on the achievement of both measurement and confirmation criteria.|Up to 10 months|Participants with Complete Response or Partial Response|||||
639313|NCT02402764|Primary|Clinical Benefit Rate|Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) ≥ 12 weeks of selinexor in patients with triple negative breast cancer (TNBC), according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of the diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Up to 10 months|All participants||Participants|||Count of Participants
639314|NCT02402322|Secondary|Change From Baseline Score in the Sheehan Disability Inventory (Social Support Subscale) at 8 Weeks and 6 Months.|This 5-item instrument assesses functional impairment at work, and in social and family life. There are 5 subscales: work, social life, family life, stress, social support. The first three subscales range from 0 to 10, with higher scores indicating greater disability. The fourth subscale (stress) range from 0 to 10, with higher scores indicating greater stress perceived. The fifth subscale (Social Support Subscale) ranges from 0 to 100, with higher scores indicating greater social support perceived.There is not a total score.|Baseline, 8 weeks, 6 months.|||units on a scale (range= 0-100)||Standard Deviation|Mean
639315|NCT02402322|Secondary|Change From Baseline Score in the Sheehan Disability Inventory (Stress Subscale) at 8 Weeks and 6 Months.|This 5-item instrument assesses functional impairment at work, and in social and family life. There are 5 subscales: work, social life, family life, stress, social support. The first three subscales range from 0 to 10, with higher scores indicating greater disability. The fourth subscale (stress) range from 0 to 10, with higher scores indicating greater stress perceived. The fifth subscale (Social Support Subscale) ranges from 0 to 100, with higher scores indicating greater social support perceived.There is not a total score.|Baseline, 8 weeks, 6 months.|||units on a scale (range= 0-10)||Standard Deviation|Mean
639316|NCT02402322|Secondary|Change From Baseline Score in the Sheehan Disability Inventory (Family Subscale) at 8 Weeks and 6 Months.|This 5-item instrument assesses functional impairment at work, and in social and family life. There are 5 subscales: work, social life, family life, stress, social support. The first three subscales range from 0 to 10, with higher scores indicating greater disability. The fourth subscale (stress) range from 0 to 10, with higher scores indicating greater stress perceived. The fifth subscale (Social Support Subscale) ranges from 0 to 100, with higher scores indicating greater social support perceived.There is not a total score.|Baseline, 8 weeks, 6 months.|||units on a scale (range= 0-10)||Standard Deviation|Mean
639317|NCT02402322|Secondary|Change From Baseline Score in the Sheehan Disability Inventory (Social Life Subscale) at 8 Weeks and 6 Months.|This 5-item instrument assesses functional impairment at work, and in social and family life. There are 5 subscales: work, social life, family life, stress, social support. The first three subscales range from 0 to 10, with higher scores indicating greater disability. The fourth subscale (stress) range from 0 to 10, with higher scores indicating greater stress perceived. The fifth subscale (Social Support Subscale) ranges from 0 to 100, with higher scores indicating greater social support perceived.There is not a total score.|Baseline, 8 weeks, 6 months.|||units on a scale (range= 0-10)||Standard Deviation|Mean
639318|NCT02402322|Secondary|Change From Baseline Score in the Sheehan Disability Inventory (Work Subscale) at 8 Weeks and 6 Months.|This 5-item instrument assesses functional impairment at work, and in social and family life. There are 5 subscales: work, social life, family life, stress, social support. The first three subscales range from 0 to 10, with higher scores indicating greater disability. The fourth subscale (stress) range from 0 to 10, with higher scores indicating greater stress perceived. The fifth subscale (Social Support Subscale) ranges from 0 to 100, with higher scores indicating greater social support perceived.There is not a total score.|Baseline, 8 weeks, 6 months.|||units on a scale (range= 0-10)||Standard Deviation|Mean
639319|NCT02402322|Secondary|Change From Baseline Score in the Beck Depression Inventory at 8 Weeks and 6 Months.|Beck Depression Inventory-II (BDI-II), Spanish adaptation (38, 39). This 21-item self-reported instrument evaluates symptoms of depression. Score range:0- 63, with 3 levels of severity, 10-18 mild depression, 19-29 moderate depression and >30 severe depression.|Baseline, 8 weeks, 6 months.|||units on a scale (range= 0-63)||Standard Deviation|Mean
639320|NCT02402322|Secondary|Change From Baseline Score in the Beck Anxiety Inventory at 8 Weeks and 6 Months.|Beck Anxiety Inventory (BAI), Spanish adaptation . This 21-item self-reported instrument evaluates the cognitive and physical symptoms of anxiety. Score range:0- 63, with 3 levels of severity 0-21 mild anxiety, 22-35 moderate anxiety and 36-63 severe anxiety.|Baseline, 8 weeks, 6 months.|||units on a scale (range= 0-63)||Standard Deviation|Mean
639321|NCT02402322|Primary|Change From Baseline Score in the Anxiety Sensitivity Index-3 at 8 Weeks and 6 Months.|This 18-item scale evaluates sensitivity to anxiety symptoms on 3 dimensions: physical, cognitive, and social.There are 3 subscales, physical, cognitive, and social. For both the subscales (which range from 0 to 24) and the total scale (which range from 0 to 72), higher scores correspond to greater anxiety sensitivity.|Baseline, 8 weeks, 6 months.|||units on a scale (range= 0-72)||Standard Deviation|Mean
639322|NCT02402322|Primary|Change From Baseline Score in the Panic Disorder Severity Scale at 8 Weeks and 6 Months.|Panic Disorder Severity Scale Self-Report (PDSS-SR). This 7-item scale assesses the severity of PD through questions about the frequency of panic attacks, associated distress, anticipatory anxiety, agoraphobic and interoceptive avoidance, and social and work impairment. Score range: 0-28. Scores up to 10 correspond with ‘‘mild,’’ those between 11 and 15 with ‘‘moderate,’’ and those at or above 16 with ‘‘severe’’ panic disorder.|Baseline, 8 weeks, 6 months.|||units on a scale (range= 0-28)||Standard Deviation|Mean
639323|NCT02402296|Secondary|Matrix Metallo-proteinase (MMP-1&9)|Their immuno-expression was assessed in the gingival samples harvested from the gingiva adjacent to hopeless teeth (planned to be extracted for dento-periodontal causes)|Day 0 and day 91 post therapy|A total of 30 localized aggressive periodontitis(LAP) participants were included in this study. Medical and dental histories were obtained and intraoral examinations were carried out at pre-screening visit. Patients were diagnosed to have LAP based on the clinical and radiographic findings.||percentage of change||Standard Deviation|Mean
639324|NCT02402296|Secondary|Gingival Index (GI)|"Using the values of the gingival index according to (Loe & Silness, 1963); 0-no bleeding on probing
delayed bleeding on probing
immediate bleeding on probing
spontaneous bleeding"|Day 0 and day 91 post therapy|A total of 30 localized aggressive periodontitis(LAP) participants were included in this study. Medical and dental histories were obtained and intraoral examinations were carried out at pre-screening visit. Patients were diagnosed to have LAP based on the clinical and radiographic findings.||percentage of change||Standard Deviation|Mean
639325|NCT02402296|Secondary|Pocket Depth (PD)|It is the distance from the base of the pocket till the gingival margin using Williams graduated probe|Day 0 and day 91 post therapy|A total of 30 localized aggressive periodontitis(LAP) participants were included in this study. Medical and dental histories were obtained and intraoral examinations were carried out at pre-screening visit. Patients were diagnosed to have LAP based on the clinical and radiographic findings||percentage of change||Standard Deviation|Mean
639326|NCT02402296|Primary|Assessment of Change in Clinical Attachment Level (CAL)|It is the distance from the base of the pocket till the cemento-enamel junction using Williams graduated probe|Day 0 and day 91 post therapy|A total of 30 localized aggressive periodontitis (LAP) participants were included in this study. Medical and dental histories were obtained and intraoral examinations were carried out at pre-screening visit. Patients were diagnosed to have LAP based on the clinical and radiographic findings measurements||percentage of change||Standard Deviation|Mean
639327|NCT02402127|Secondary|Average Coefficient of Friction of Unworn Lenses|Unworn contact lenses were removed from the commercial packaging and the coefficient of friction of the unworn lenses was measured by the inclined plane method. A lower coefficient of friction may indicate higher contact lens lubricity.|Day 1 (each product)|Intention to treat participants with non-missing observations||unitless|Participants|Standard Deviation|Mean
639328|NCT02402127|Primary|Average Coefficient of Friction of Worn Lenses at 16 Hours|Worn contact lenses were removed from the participant's eye and the coefficient of friction was measured by the inclined plane method. A lower coefficient of friction may indicate higher contact lens lubricity. The ex-vivo lubricity was carried out on one lens (one eye) only.|Day 1, Hour 16, each product|Intention to treat participants with non-missing observations||unitless||Standard Deviation|Mean
639351|NCT02400710|Secondary|Engagement in PTSD Specialty Care as Measured by the Electronic Medical Record|Attendance of at least one session in the PTSD specialty clinic following the completion of the study intervention.|16 weeks|||participants|||Number
639352|NCT02400710|Primary|PTSD Checklist-Specific|Measures the 17 symptoms of PTSD according to the DSM-IV. Each symptoms is measured on a 1-5 scale, with higher numbers indicated greater severity. The total range of the scale is 17-85.|8 weeks|||units on a scale||Standard Deviation|Mean
639353|NCT02400346|Primary|Number of Patients With Treatment-Emergent Adverse Events|Treatment-emergent adverse event is an adverse event that started or increased in intensity at or after baseline visit|Baseline to 30 weeks|||Participants|||Count of Participants
639329|NCT02401867|Primary|Concordance Between Vaginal Self-swab Results and Provider-collected Cervical Swab Results for HPV DNA Among Sexually Active FTM Adults|Quantitatively assessed the non-inferiority of vaginal self-swab for HPV DNA compared to provider-collected cervical swab for HPV via laboratory confirmed testing in sexually active FTM adults. Compared the concordance of the positive self-swab HPV DNA test results to the positive cervical provider swab HPV DNA test results (reference) using the McNemar’s test, a two-sample test for binomial proportions for matched-pair data.|1 day|Analytic sample =131: 10 participants did not receive both the vaginal self-swab HPV DNA test and the provider cervical test (reference); 7 received the self, but not the provider; 1 received the provider, but not the self; 2 did not receive either test. Additionally, 9 of the provider samples could not be assayed due to low cellular content.||Participants|||Count of Participants
639330|NCT02401555|Primary|Diagnostic Result of Assay (Bio-Rad Geenius HIV 1/2 Supplemental Assay) From Accuracy Analysis|The purpose of this study was to evaluate the performance of the Bio-Rad Geenius HIV1/2 Supplemental Assay, a single-use immunochromatographic assay for the confirmation and differentiation of individual antibodies to Human Immunodeficiency Virus Types1 and 2 (HIV-1 and HIV-2) in fingerstick whole blood, venous whole blood, serum, or plasma (EDTA, heparin and sodium citrate). The Accuracy analysis on the serum samples is a proportion of results that are correctly identified as such.|Up to 9 months|||Percentage of True Results||95% Confidence Interval|Number
639331|NCT02401529|Secondary|Average Frequency of Meals Per Day|average frequency of meals (1 meal, 2 meals, if more specify)|average number of meals consumed per day for the 1st three days post-surgery|||participants|||Number
639332|NCT02401529|Secondary|Average Amount of Meal Per Day|adequacy of meals (inadequate, adequate)|3 days|||participants|||Number
639333|NCT02401529|Secondary|Onset of 1st Post-operative Oral Intake|feeding onset (1st day i. surgery day, 2nd day, 3rd day)|Onset of 1st post-operative oral intake recorded within the 1st 3days post-surgery|||participants|||Number
639334|NCT02401529|Primary|Total Number of Post-operative Vomiting Episodes|Postoperative vomiting number of attacks (no vomiting,1, 2, 3, if more specify)|total number of post-operative vomiting episodes which were experienced within the 1st week post-surgery|||participants|||Number
639335|NCT02401529|Primary|Occurence of Postoperative Vomiting|Postoperative vomiting occurrence (yes, no)|7 days|||participants|||Number
639336|NCT02401529|Primary|Duration of Post-operative Nausea|Postoperative nausea duration (no nausea,1 day, 2 days, 3 days, 4 days, if more specify)|7 days|||participants|||Number
639337|NCT02401529|Primary|Onset of Post-operative Nausea|Postoperative nausea onset (no nausea, immediate, 1st day, 2nd day, 3rd day, 4th day, 5th day, 6th day, 7th day)|onset of 1st ocurence of nausea attack within the 1st week post-surgery|||participants|||Number
639338|NCT02401529|Primary|Occurence of Post-operative Nausea|Postoperative nausea occurence (yes, no)|7 days|||participants|||Number
639339|NCT02401529|Primary|Duration of Post-operative Pain|4 selections (1 day, 2 days, 3 days, if more specify)|number of days at which pain was experienced within the the 1st sevn days post -surgery|||participants|||Number
639340|NCT02401529|Primary|Maximum Severity of Post-operative Pain|5 grades (pain free, low disability and low intensity, low disability and high intensity, high disability and moderate intensity, high disability and severly limiting)|The severest pain grade felt within a week|||participants|||Number
639341|NCT02401464|Secondary|Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Laboratory Values||Baseline up to Day 6 of Intervention Period 2|The safety analysis set included all participants who received the study drug at least once.||participants|||Number
639342|NCT02401464|Secondary|Number of Participants Who Had Clinically Meaningful Changes From Baseline in 12-lead Electrocardiograms (ECG)||Baseline up to Day 6 of Intervention Period 2|The safety analysis set included all participants who received the study drug at least once.||participants|||Number
639343|NCT02401464|Secondary|Number of Participants With TEAEs Related to Body Weight||Baseline up to Day 6 of Intervention Period 2|The safety analysis set included all participants who received the study drug at least once.||participants|||Number
639344|NCT02401464|Secondary|Number of Participants With TEAEs Related to Vital Signs||Baseline up to Day 6 of Intervention Period 2|The safety analysis set included all participants who received the study drug at least once.||participants|||Number
639345|NCT02401464|Secondary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)||Baseline up to Day 6 of Intervention Period 2|The safety analysis set included all participants who received the study drug at least once.||participants|||Number
639346|NCT02401464|Primary|Cmax: Maximum Observed Plasma Concentration for TAK-536 in Granule Cohort||Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose|The pharmacokinetic analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and were evaluable for pharmacokinetics.||ng/mL||Standard Deviation|Mean
639347|NCT02401464|Primary|AUC(0-48): Area Under the Plasma Concentration-Time Curve From Time 0 to 48 Hours Postdose for TAK-536 in Granule Cohort||Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose|The pharmacokinetic analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and were evaluable for pharmacokinetics.||ng*hr/mL||Standard Deviation|Mean
639348|NCT02401464|Primary|Cmax: Maximum Observed Plasma Concentration for TAK-536 in Dry Syrup Cohort||Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose|The pharmacokinetic analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and were evaluable for pharmacokinetics.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
639349|NCT02401464|Primary|AUC(0-48): Area Under the Plasma Concentration-Time Curve From Time 0 to 48 Hours Postdose for TAK-536 in Dry Syrup Cohort||Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose|The pharmacokinetic analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and were evaluable for pharmacokinetics.||nanogram*hour per milliliter (ng*hr/mL)||Standard Deviation|Mean
639412|NCT02396147|Secondary|Terminal Phase Elimination Half-Life (T1/2) for TAK-385||Days 1, 11, and 21 predose and at multiple time points (up to 120 hours) post-dose|Pharmacokinetic (PK)-Evaluable population included participants who had sufficient dosing and PK data for analysis, and who did not receive any excluded medications.||hours||Standard Deviation|Mean
639354|NCT02400333|Secondary|Participants With Clinically Significant Findings in Hematology, Clinical Chemistry and Urinalysis.|Participants were assessed through each laboratory variables for any significant abnormalities. Hematology assessments included white blood cell count, red blood cell count, hemoglobin, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin and others. Clinical chemistry assessment included testing levels of sodium, potassium, urea, creatinine, albumin, calcium, glucose (fasting) and others. Urinalysis assessment included glucose, protein, blood and microscopy (if positive for blood or protein).|At screening, at admission on Day -1 to each treatment period and at follow-up.|The safety analysis set included all participants who received at least one dose of ticagrelor and for whom any safety post-dose data were available.||participants|||Number
639355|NCT02400333|Secondary|Participants With Significant Findings in 12-Lead Electrocardiography (ECG).|A 12-lead ECG was obtained after the participant rested in supine position for at least 10 minutes. The study physician was to judge the overall interpretation as normal or abnormal. If abnormal, it was decided as to whether or not the abnormality was clinically significant and the reason for the abnormality was recorded.|At screening and at follow-up.|The safety analysis set included all participants who received at least one dose of ticagrelor and for whom any safety post-dose data were available.||participants|||Number
639356|NCT02400333|Secondary|Mean Change From Baseline for Vital Signs in Supine Pulse Rate.|Vital signs were collected after the participant has rested in the supine position for at least 5 minutes.|Day 1 (2, 4 hours post-dose) and Day 2 (24 hours post-dose).|The safety analysis set included all participants who received at least one dose of ticagrelor and for whom any safety post-dose data were available.||bpm||Standard Deviation|Mean
639357|NCT02400333|Secondary|Mean Change From Baseline for Vital Signs of Supine Blood Pressure (SBP) and Diastolic BP (DBP).|The following variables were collected after the participants had rested in the supine position for at least 5 minutes: SBP and DBP.|Day 1 (2, 4 hours post-dose) and Day 2 (24 hours post-dose).|The safety analysis set included all participants who received at least one dose of ticagrelor and for whom any safety post-dose data were available.||mmHg||Standard Deviation|Mean
639358|NCT02400333|Secondary|Percentage of Participants With Adverse Events (AEs).|An AE is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. The term AE is used generally to include any AE whether serious or non-serious. A serious AE (SAE) is an AE that fulfills one or more of the following criteria: results in death, is immediately life-threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity or substantial disruption of the ability to conduct normal life functions; is a congenital abnormality or birth defect; is an important medical event that may jeopardize the participant or may require medical intervention to prevent one of the outcomes listed above.|SAEs were recorded from the signing of informed consent and AEs were recorded from randomisation until the final follow-up visit.|The safety analysis set included all participants who received at least one dose of ticagrelor and for whom any safety post-dose data were available.||percentage of participants|||Number
639359|NCT02400333|Secondary|Ratio of Metabolite AUC [0-∞] to Parent AUC [0-∞], Adjusted for Differences in Molecular Weights (MRAUC [0-∞]) of Metabolite AR-C124910XX.|Assesssment of MRAUC [0-∞] (Ratio of metabolite AUC [0-∞] to parent AUC [0-∞], adjusted for differences in molecular weights) of ticagrelor and its active metabolite AR-C124910XX following single doses of the OD tablet when administered with water, without water and suspended in water to be administered through nasogastric tubes, compared to ticagrelor IR tablets.|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The PK analysis set consisted of all participants in the safety analysis set for whom at least one of the primary PK parameters, for a given analyte, can be calculated for at least two treatment periods and who had no major protocol deviations.||ratio||Geometric Coefficient of Variation|Geometric Mean
639360|NCT02400333|Secondary|Ratio of Metabolite AUC(0-t) to Parent AUC(0-t), Adjusted for Differences in Molecular Weights (MRAUC[0-t]) of Metabolite AR-C124910XX.|Assesssment of MRAUC(0-t) (Ratio of metabolite AUC(0-t) to parent AUC(0-t), adjusted for differences in molecular weights) of ticagrelor and its active metabolite AR-C124910XX following single doses of the OD tablet when administered with water, without water and suspended in water to be administered through nasogastric tubes, compared to ticagrelor IR tablets.|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The PK analysis set consisted of all participants in the safety analysis set for whom at least one of the primary PK parameters, for a given analyte, can be calculated for at least two treatment periods and who had no major protocol deviations.||ratio||Geometric Coefficient of Variation|Geometric Mean
639361|NCT02400333|Secondary|Ratio of Metabolite Cmax to Parent Cmax, Adjusted for Differences in Molecular Weights (MRCmax) of Metabolite AR-C124910XX.|Assesssment of MRCmax (ratio of metabolite Cmax to parent Cmax, adjusted for differences in molecular weights) of ticagrelor and its active metabolite AR-C124910XX following single doses of the OD tablet when administered with water, without water and suspended in water to be administered through nasogastric tubes, compared to ticagrelor IR tablets.|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The PK analysis set consisted of all participants in the safety analysis set for whom at least one of the primary PK parameters, for a given analyte, can be calculated for at least two treatment periods and who had no major protocol deviations.||ratio||Geometric Coefficient of Variation|Geometric Mean
639362|NCT02400333|Secondary|Half-life Associated With Terminal Slope (λz) of a Semi-logarithmic Concentration-time Curve (t½λz) of Ticagrelor and Its Active Metabolite AR-C124910XX.|Blood samples for the determination of plasma concentrations of both ticagrelor and AR-C124910XX were collected at pre-dose (0 hours) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The PK analysis set consisted of all participants in the safety analysis set for whom at least one of the primary PK parameters, for a given analyte, can be calculated for at least two treatment periods and who had no major protocol deviations.||h||Standard Deviation|Mean
639413|NCT02396147|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-385||Days 1, 11, and 21 predose and at multiple time points (up to 120 hours) post-dose|Pharmacokinetic (PK)-Evaluable population included participants who had sufficient dosing and PK data for analysis, and who did not receive any excluded medications.||hours||Full Range|Median
639363|NCT02400333|Secondary|Time to Reach Maximum Observed Concentration (Tmax) of Ticagrelor and Its Active Metabolite AR-C124910XX.|Blood samples for the determination of plasma concentrations of both ticagrelor and AR-C124910XX were collected at pre-dose (0 hours) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The PK analysis set consisted of all participants in the safety analysis set for whom at least one of the primary PK parameters, for a given analyte, can be calculated for at least two treatment periods and who had no major protocol deviations.||h||Full Range|Median
639364|NCT02400333|Primary|Area Under Plasma Concentration-time Curve From Zero to Infinity (AUC [0-∞]).|Blood samples for the determination of plasma concentrations of both ticagrelor and AR-C124910XX were collected at pre-dose (0 hours) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The PK analysis set consisted of all participants in the safety analysis set for whom at least one of the primary PK parameters, for a given analyte, can be calculated for at least two treatment periods and who had no major protocol deviations.||h·ng/mL||Geometric Coefficient of Variation|Geometric Mean
639365|NCT02400333|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Analyte Concentration (AUC[0-t]) of Ticagrelor and Its Active Metabolite AR-C124910XX.|Blood samples for the determination of plasma concentrations of both ticagrelor and AR-C124910XX were collected at pre-dose (0 hours) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The PK analysis set consisted of all participants in the safety analysis set for whom at least one of the primary PK parameters, for a given analyte, can be calculated for at least two treatment periods and who had no major protocol deviations.||h·ng/mL||Geometric Coefficient of Variation|Geometric Mean
639366|NCT02400333|Primary|Maximum Observed Plasma Concentration (Cmax) of Ticagrelor and Its Active Metabolite AR-C124910XX.|Blood samples for the determination of plasma concentrations of both ticagrelor and AR-C124910XX were collected at pre-dose (0 hours) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The Pharmacokinetic (PK) analysis set consisted of all participants in the safety analysis set for whom at least one of the primary PK parameters, for a given analyte, can be calculated for at least two treatment periods and who had no major protocol deviations.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
639367|NCT02399345|Secondary|Percentage of Subjects With Post-treatment Relapse|Percentage of subjects with HCV RNA less than the lower limit of quantification at the end of treatment with confirmed HCV RNA greater than or equal to the lower limit of quantification through 12 weeks post treatment|Up to 12 weeks after last actual dose of active study drug|ITT population||percentage of participants|||Number
639368|NCT02399345|Secondary|Percentage of Subjects With On-treatment Virologic Failure|Virologic failure during treatment was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment; confirmed increase from nadir in HCV RNA (defined as 2 consecutive HCV RNA measurements > 1 log10 IU/mL above nadir) during treatment; or failure to suppress during treatment (defined as all values of HCV RNA ≥ LLOQ during treatment).|6 weeks|ITT population||percentage of participants|||Number
639369|NCT02399345|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment|The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug. The LLOQ for the assay was 25 IU/mL.|12 weeks after the last actual dose of study drug|Intent-to-treat (ITT) population: All randomized participants who received at least 1 dose of study drug.||percentage of participants|||Number
639370|NCT02399163|Secondary|Change in Saliva Fluoride Concentration From Baseline (Post-treatment) to Day 14|Fluoride concentration in saliva was measured after collecting saliva samples at the following time points: - at Day 1 post supervised treatment at site. - at Day 14 post treatment. The amount of fluoride in the samples was calculated based on the amount of fluoride divided by the volume of the sample and expressed as μg/mL of sample.|Baseline up to Day 14|PP population included all participants who were randomized into the study, received at least one dose of study product, had at least one post-baseline efficacy assessment and had no protocol violations deemed to affect efficacy during the study.||μg/mL||Standard Deviation|Mean
639371|NCT02399163|Secondary|Change in Saliva Fluoride Concentration From Baseline (Pre-treatment) to Day 14|Fluoride concentration in saliva was measured after collecting saliva samples at the following time points: - at Day 1 baseline prior to supervised treatment. - at day 1 post supervised treatment at site. - at Day 14 post treatment. The amount of fluoride in the samples was calculated based on the amount of fluoride divided by the volume of the sample and expressed as μg/mL of sample.|Baseline to Day14|PP population included all participants who were randomized into the study, received at least one dose of study product, had at least one post-baseline efficacy assessment and had no protocol violations deemed to affect efficacy during the study.||microgram per mililitre(μg/mL )||Standard Deviation|Mean
639372|NCT02399163|Secondary|Enamel Fluoride Uptake|The microdrill enamel biopsy technique was used to analyze the fluoride uptake by enamel. Each enamel specimen was mounted on the long axis of a drill attached to a microdrill and drilled to a depth of approximately 100 micrometer (μm) through the entire lesion (four cores per specimen). The enamel powder pooled from four drilling samples was then immediately analyzed for fluoride content using fluoride specific electrode and pH/ion meter. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores and expressed as microgram per square centimeter (μg/cm^2).|Baseline to 14 days|PP population included all participants who were randomized into the study, received at least one dose of study product, had at least one post-baseline efficacy assessment and had no protocol violations deemed to affect efficacy during the study.||microgram per square centimeter(μg/cm^2)||Standard Deviation|Mean
639414|NCT02396147|Secondary|Percentage of Participants With Markedly Abnormal Vital Sign Measurements|The percentage of participants with any markedly abnormal standard vital sign measurements was collected throughout study.|From Day 1 to Day 26|Safety population included all participants who received at least 1 dose of study drug.||percentage of participants|||Number
639373|NCT02399163|Secondary|Percentage Surface Microhardness Recovery (SMHR) of Placebo Dentifrice/Fluoride Rinse, Placebo Dentifrice/No Rinse, Fluoride Dentifrice/No Rinse and Fluoride Dentifrice/Fluoride Rinse|SMHR test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR was performed ex-vivo and determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. % SMH recovery was calculated from indentation length (micrometer [μm]) of sound enamel specimen at baseline(B), indentation length (μm) after in vitro demineralization(D1), indentation length (μm) after intra-oral exposure (R): [D1-R/D1-B]*100.|Baseline to 14 days|PP population included all participants who were randomized into the study, received at least one dose of study product, had at least one post-baseline efficacy assessment and had no protocol violations deemed to affect efficacy during the study.||% SMHR||Standard Deviation|Mean
639374|NCT02399163|Primary|Percentage Surface Microhardness Recovery (%SMHR) of Placebo Dentifrice/Fluoride Rinse Compared to Placebo Dentifrice/No Rinse|SMHR test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR was performed ex-vivo and determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents re-hardening of enamel surface. % SMH recovery was calculated from indentation length (micrometer [μm]) of sound enamel specimen at baseline(B), indentation length (μm) after in vitro demineralization(D1), indentation length (μm) after intra-oral exposure (R): [D1-R/D1-B]*100.|Baseline to 14 days|Per-protocol (PP) population included all participants who were randomized into the study, received at least one dose of study product, had at least one post-baseline efficacy assessment and had no protocol violations deemed to affect efficacy during the study.||% SMHR||Standard Deviation|Mean
639375|NCT02399111|Secondary|Assess the Safety of the Devise by Monitoring Incidence of Bleeding , Seroma Formation|This study was terminated prior to collection of data.|30 days||||||
639376|NCT02399111|Primary|Incidence of Wound Infection With Szilagyi Grade|This study was terminated prior to gathering of data.|30 days||||||
639377|NCT02397915|Secondary|Number of Participants Responding to the Delayed Attributes Question Regarding Likeliness to Comply if Prescribed|Delayed attributes questionnaire was used to evaluate delayed ratings of par. for individual attributes of FF and MF nasal spray. Number of par. responding to product attributes i.e. taste, using delayed attributes questionnaire, Question 12, “How likely to comply if prescribed?” are summarized. The delayed attributes questionnaire was completed 2 minutes after dosing, in Period 1 and 2. Par. specified their responses on a 6-point scale: 0: very likely; 1: moderately likely; 2: somewhat likely; 3: neither likely nor unlikely; 4: somewhat unlikely; 5; moderately unlikely; 6: very unlikely. Delayed attribute ratings were analyzed using an analysis of variance mixed model with participant as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of delayed attribute rating scores were adjusted for multiplicity using Hochberg’s method.|Approximatly two minutes after the dosing in Period 1 and 2|PP Population||Participants|||Number
639378|NCT02397915|Secondary|Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Product.|Delayed attributes questionnaire was used to evaluate delayed ratings of participant for individual attributes of FF and MF nasal spray. Number of participants responding to product attributes i.e. taste, using delayed attributes questionnaire, Question 11, “How satisfied with product?” are summarized. The delayed attributes questionnaire was completed 2 minutes after dosing, in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: very satisfied; 1: moderately satisfied; 2: somewhat satisfied; 3: neither satisfied nor dissatisfied; 4: somewhat dissatisfied; 5; moderately dissatisfied; 6: very dissatisfied. Delayed attribute ratings were analyzed using an analysis of variance mixed model with participant as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of delayed attribute rating scores were adjusted for multiplicity using Hochberg’s method.|Approximatly two minutes after the dosing in Period 1 and 2|PP Population||Participants|||Number
639379|NCT02397915|Secondary|Number of Participants Responding to the Delayed Attributes Question Regarding Bothersome Nasal Irritation.|Delayed attributes questionnaire was used to evaluate delayed ratings of participant for individual attributes of FF and MF nasal spray. Number of participants responding to product attributes using delayed attributes questionnaire, Question 10, “How bothersome was nasal irritation?” are summarized. The delayed attributes questionnaire was completed 2 minutes after dosing, in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: none; 1: very slightly; 2: slightly; 3: neither slightly nor moderately; 4: moderately; 5; markedly; 6: very markedly. Delayed attribute ratings were analyzed using an analysis of variance mixed model with participant as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of delayed attribute rating scores were adjusted for multiplicity using Hochberg’s method.|Approximatly two minutes after the dosing in Period 1 and 2|PP Population. Only participants responded to the question were analyzed.||Participants|||Number
639380|NCT02397915|Secondary|Number of Participants Responding to the Delayed Attributes Question Regarding Nasal Irritation.|Delayed attributes questionnaire was used to evaluate delayed ratings of participant for individual attributes of FF and MF nasal spray. Number of participants responding to product attributes using delayed attributes questionnaire, Question 9, “Did product cause nasal irritation?” are summarized. The delayed attributes questionnaire was completed 2 minutes after dosing, in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: no; 1: very slightly; 2: slightly; 3: neither slightly nor moderately; 4: moderately; 5; markedly; 6: very markedly. Delayed attribute ratings were analyzed using an analysis of variance mixed model with participant as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of delayed attribute rating scores were adjusted for multiplicity using Hochberg’s method.|Approximatly two minutes after the dosing in Period 1 and 2|PP Population||Participants|||Number
639429|NCT02395055|Primary|Maximum Concentration of Adalimumab After Single SC Injection of BCD-057/Humira||0, 6, 24, 48, 72, 96, 120, 144, 168, 192, 336, 672, 1008, 1440, 1680 hours post-dose|All patients who received one injection of adalimumab.||ng/ml||Inter-Quartile Range|Median
639381|NCT02397915|Secondary|Number of Participants Responding to the Delayed Attributes Question Regarding Soothing.|Delayed attributes questionnaire was used to evaluate delayed ratings of participant for individual attributes of FF and MF nasal spray. Number of participants responding to product attributes using delayed attributes questionnaire, Question 8, “Did product feel soothing?” are summarized. The delayed attributes questionnaire was completed 2 minutes after dosing, in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: none; 1: very slightly; 2: slightly; 3: neither slightly nor moderately; 4: moderately; 5; markedly; 6: very markedly. Delayed attribute ratings were analyzed using an analysis of variance mixed model with participant as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of delayed attribute rating scores were adjusted for multiplicity using Hochberg’s method.|Approximatly two minutes after the dosing in Period 1 and 2|PP Population||Participants|||Number
639382|NCT02397915|Secondary|Number of Participants Responding to the Delayed Attributes Question Regarding Smedicine Running Out of Nose.|Delayed attributes questionnaire was used to evaluate delayed ratings of participant for individual attributes of FF and MF nasal spray. Number of participants responding to product attributes using delayed attributes questionnaire, Question 7, “Did medicine run out of nose?” are summarized. The delayed attributes questionnaire was completed 2 minutes after dosing, in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: none; 1: very slightly; 2: slightly; 3: neither slightly nor moderately; 4: moderately; 5; markedly; 6: very markedly. Delayed attribute ratings were analyzed using an analysis of variance mixed model with participant as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of delayed attribute rating scores were adjusted for multiplicity using Hochberg’s method.|Approximatly two minutes after the dosing in Period 1 and 2|PP Population||Participants|||Number
639383|NCT02397915|Secondary|Number of Participants Responding to the Delayed Attributes Question Regarding Medicine Running Down Throat.|Delayed attributes questionnaire was used to evaluate delayed ratings of participant for individual attributes of FF and MF nasal spray. Number of participants responding to product attributes using delayed attributes questionnaire, Question 6, “Did medicine run down throat?” are summarized. The delayed attributes questionnaire was completed 2 minutes after dosing, in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: none; 1: very slightly; 2: slightly; 3: neither slightly nor moderately; 4: moderately; 5; markedly; 6: very markedly. Delayed attribute ratings were analyzed using an analysis of variance mixed model with participant as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of delayed attribute rating scores were adjusted for multiplicity using Hochberg’s method.|Approximatly two minutes after the dosing in Period 1 and 2|PP Population||Participants|||Number
639384|NCT02397915|Secondary|Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Aftertaste.|Delayed attributes questionnaire was used to evaluate delayed ratings of par. for individual attributes of FF and MF nasal spray. Number of par. responding to product attributes i.e. taste, using delayed attributes questionnaire, Question 5, “How satisfied with aftertaste?” are summarized. The delayed attributes questionnaire was completed 2 minutes after dosing, in Period 1 and 2. Par. specified their responses on a 6-point scale: 0: very satisfied; 1: moderately satisfied; 2: somewhat satisfied; 3: neither satisfied nor dissatisfied; 4: somewhat dissatisfied; 5; moderately dissatisfied; 6: very dissatisfied. Delayed attribute ratings were analyzed using an analysis of variance mixed model with par. as a random effect, and country, treatment, period, and BL rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of delayed attribute rating scores were adjusted for multiplicity using Hochberg’s method.|Approximatly two minutes after the dosing in Period 1 and 2|PP Population. Only participants responded to the question were analyzed.||Participants|||Number
639385|NCT02397915|Secondary|Number of Participants Responding to the Delayed Attributes Question Regarding Aftertaste.|Delayed attributes questionnaire was used to evaluate delayed ratings of participant for individual attributes of FF and MF nasal spray. Number of participants responding to product attributes i.e. taste, using delayed attributes questionnaire, Question 4, “Did product have an aftertaste?” are summarized. The delayed attributes questionnaire was completed 2 minutes after dosing, in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: no; 1: very mild; 2: mild; 3: neither mild nor strong; 4: slightly strong; 5; moderately strong; 6: very strong. Immediate attribute ratings were analyzed using an analysis of variance mixed model with participant as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of delayed attribute rating scores were adjusted for multiplicity using Hochberg’s method.|Approximatly two minutes after the dosing in Period 1 and 2|PP Population||Participants|||Number
639386|NCT02397915|Secondary|Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction Not to Have Scent/Odor.|Delayed attributes questionnaire was used to evaluate delayed ratings of par. for individual attributes of FF and MF nasal spray. Number of par. responding to product attributes i.e. scent/odor, using delayed attributes questionnaire, Question 3, “How satisfied not to have scent/odor?” are summarized. The delayed attributes questionnaire was completed 2 minutes after dosing, in Period 1 and 2. Par. specified their responses on a 6-point scale: 0: very satisfied; 1: moderately satisfied; 2: somewhat satisfied; 3: neither satisfied nor dissatisfied; 4: somewhat dissatisfied; 5; moderately dissatisfied; 6: very dissatisfied. Delayed attribute ratings were analyzed using an analysis of variance mixed model with par. as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of delayed attribute rating scores were adjusted for multiplicity using Hochberg’s method.|Approximatly two minutes after the dosing in Period 1 and 2|PP Population. Only participants responded to the question were analyzed.||Participants|||Number
639415|NCT02396147|Secondary|Percentage of Participants With Electrocardiogram (ECG) Parameters Abnormal and Clinically Significant|A 12-lead ECG was administered. The investigator interpreted the ECG using one of the following categories: within normal limits, abnormal but not clinically significant, or abnormal and clinically significant.|Days 1, 11, 21 and 26|Safety population included all participants who received at least 1 dose of study drug.||percentage of participants|||Number
639444|NCT02394457|Primary|Headache Pain Score|Numerical 0-10 (0 no pain, 10 worst pain)|3 days post procedure|||units on a scale||Standard Deviation|Mean
639387|NCT02397915|Secondary|Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Scent/Odor.|Delayed attributes questionnaire was used to evaluate delayed ratings of par. for individual attributes of FF and MF nasal spray. Number of par. responding to product attributes i.e. scent/odor, using delayed attributes questionnaire, Question 2, “How satisfied with scent/odor?” are summarized. The delayed attributes questionnaire was completed 2 minutes after dosing, in Period 1 and 2. Par. specified their responses on a 6-point scale: 0: very satisfied; 1: moderately satisfied; 2: somewhat satisfied; 3: neither satisfied nor dissatisfied; 4: somewhat dissatisfied; 5; moderately dissatisfied; 6: very dissatisfied. Delayed attribute ratings were analyzed using an analysis of variance mixed model with par. as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of delayed attribute rating scores were adjusted for multiplicity using Hochberg’s method.|Approximatly two minutes after the dosing in Period 1 and 2|PP Population. Only participants responded to the question were analyzed.||Participants|||Number
639388|NCT02397915|Secondary|Number of Participants Responding to the Delayed Attributes Question Regarding Scent/Odor.|Delayed attributes questionnaire was used to evaluate immediate ratings of participant for individual attributes of FF and MF nasal spray. Number of participants responding to product attributes i.e. scent/odor, using delayed attributes questionnaire, Question 1, “Did product have a scent/odor?” are summarized. The delayed attributes questionnaire was completed 2 minutes after dosing, in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: none; 1: very mild; 2: mild; 3: neither mild nor strong; 4: slightly strong; 5; moderately strong; 6: very strong. Delayed attribute ratings were analyzed using an analysis of variance mixed model with participant as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of delayed attribute rating scores were adjusted for multiplicity using Hochberg’s method.|Approximatly two minutes after the dosing in Period 1 and 2|PP Population||Participants|||Number
639389|NCT02397915|Secondary|Number of Participants Responding to the Immediate Attributes Question Regarding Sneezing|Immediate attributes questionnaire was used to evaluate immediate ratings of par. for individual attributes of FF and MF nasal spray. Number of par. responding to product attributes using immediate attributes questionnaire, Question 9, “Did product make want to sneeze?” are summarized. The immediate attributes questionnaire was completed immediately following each treatment in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: no urgency; 1: very slightly urgency; 2: slightly urgency; 3: neither slightly nor moderately urgency; 4: moderately urgency; 5; markedly urgency; 6: very markedly urgency. Immediate attribute ratings were analyzed using an analysis of variance mixed model with par. as a random effect, and country, treatment, period, and BL rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of immediate attribute rating scores were adjusted for multiplicity using Hochberg’s method.|Immediately following each treatment in Period 1 and 2|PP Population||Participants|||Number
639390|NCT02397915|Secondary|Number of Participants Responding to the Immediate Attributes Question Regarding Soothing|Immediate attributes questionnaire was used to evaluate immediate ratings of participant for individual attributes of FF and MF nasal spray. Number of participants responding to product attributes using immediate attributes questionnaire, Question 8, “Did product feel soothing?” are summarized. The immediate attributes questionnaire was completed immediately following each treatment in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: none; 1: very slightly; 2: slightly; 3: neither slightly nor moderately; 4: moderately; 5; markedly; 6: very markedly. Immediate attribute ratings were analyzed using an analysis of variance mixed model with participant as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of immediate attribute rating scores were adjusted for multiplicity using Hochberg’s method.|Immediately following each treatment in Period 1 and 2|PP Population||Participants|||Number
639391|NCT02397915|Secondary|Number of Participants Responding to the Immediate Attributes Question Regarding Medicine Running Out of Nose.|Immediate attributes questionnaire was used to evaluate immediate ratings of participant for individual attributes of FF and MF nasal spray. Number of participants responding to product attributes using immediate attributes questionnaire, Question 7, “Did medicine run out of nose?” are summarized. The immediate attributes questionnaire was completed immediately following each treatment in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: none; 1: very slightly; 2: slightly; 3: neither slightly nor moderately; 4: moderately; 5; markedly; 6: very markedly. Immediate attribute ratings were analyzed using an analysis of variance mixed model with participant as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of immediate attribute rating scores were adjusted for multiplicity using Hochberg’s method.|Immediately following each treatment in Period 1 and 2|PP Population||Participants|||Number
639392|NCT02397915|Secondary|Number of Participants Responding to the Immediate Attributes Question Regarding Medicine Running Down Throat|Immediate attributes questionnaire was used to evaluate immediate ratings of participant for individual attributes of FF and MF nasal spray. Number of participants responding to product attributes using immediate attributes questionnaire, Question 6, “Did medicine run down throat?” are summarized. The immediate attributes questionnaire was completed immediately following each treatment in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: none; 1: very slightly; 2: slightly; 3: neither slightly nor moderately; 4: moderately; 5; markedly; 6: very markedly. Immediate attribute ratings were analyzed using an analysis of variance mixed model with participant as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of immediate attribute rating scores were adjusted for multiplicity using Hochberg’s method.|Immediately following each treatment in Period 1 and 2|PP Population||Participants|||Number
639416|NCT02396147|Secondary|Number of Participants With Shifts From Normal at Baseline in Safety Laboratory Values in More Than 1 Participant|Participants with shifts from normal at Baseline in safety laboratory values (Clinical Chemistry, Hematology and Urinalysis) collected throughout study. Low=below normal reference range, Normal=within reference range, High=above normal reference range and Abnormal=outside of normal reference range.|Baseline and Days 4, 10, 14, 20, 24 and 26|Safety population included all participants who received at least 1 dose of study drug.||participants|||Number
639393|NCT02397915|Secondary|Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction With Immediate Taste.|Immediate attributes questionnaire was used to evaluate immediate ratings of par. for individual attributes of FF and MF nasal spray. Number of par. responding to product attributes i.e. taste, using immediate attributes questionnaire, Question 5, “How satisfied with immediate taste?” are summarized. The immediate attributes questionnaire was completed immediately following each treatment in Period 1 and 2. Par. specified their responses on a 6-point scale: 0: very satisfied; 1: moderately satisfied; 2: somewhat satisfied; 3: neither satisfied nor dissatisfied; 4: somewhat dissatisfied; 5; moderately dissatisfied; 6: very dissatisfied. Immediate attribute ratings were analyzed using an analysis of variance mixed model with par. as a random effect, and country, treatment, period, and BL rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of immediate attribute rating scores were adjusted for multiplicity using Hochberg’s method.|Immediately following each treatment in Period 1 and 2|PP Population. Only participants responded to the question were analyzed.||Participants|||Number
639394|NCT02397915|Secondary|Number of Participants Responding to the Immediate Attributes Question Regarding Immediate Taste.|Immediate attributes questionnaire was used to evaluate immediate ratings of participant for individual attributes of FF and MF nasal spray. Number of participants responding to product attributes i.e. taste, using immediate attributes questionnaire, Question 4, “Did product have an immediate taste?” are summarized. The immediate attributes questionnaire was completed immediately following each treatment in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: no; 1: very mild; 2: mild; 3: neither mild nor strong; 4: slightly strong; 5; moderately strong; 6: very strong. Immediate attribute ratings were analyzed using an analysis of variance mixed model with participant as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of immediate attribute rating scores were adjusted for multiplicity using Hochberg’s method.|Immediately following each treatment in Period 1 and 2|PP Population||Participants|||Number
639395|NCT02397915|Secondary|Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction Not to Have Scent/Odor|Immediate attributes questionnaire was used to evaluate immediate ratings of par. for individual attributes of FF and MF nasal spray. Number of par. responding to product attributes i.e. scent/odor, using immediate attributes questionnaire, Question 3, “How satisfied not to have scent/odor?” are summarized. The immediate’ attributes questionnaire was completed immediately following each trt in Period 1 and 2. Par. specified their responses on a 6-point scale: 0: very satisfied; 1: moderately satisfied; 2: somewhat satisfied; 3: neither satisfied nor dissatisfied; 4: somewhat dissatisfied; 5; moderately dissatisfied; 6: very dissatisfied. Immediate attribute ratings were analyzed using an analysis of variance mixed model with par. as a random effect, and country, trt, period, and BL rhinitis symptomatology subgroup, and trt sequence as main effects. P-values associated with tests of immediate attribute rating scores were adjusted for multiplicity using Hochberg’s method.|Immediately following each treatment in Period 1 and 2|PP Population. Only participants responded to the question were analyzed.||Participants|||Number
639396|NCT02397915|Secondary|Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction With Scent/Odor|Immediate attributes questionnaire (ques) was used to evaluate immediate ratings of par. for individual attributes of FF and MF nasal spray. Number of par. responding to product attributes i.e. scent/odor, using immediate attributes ques, Question 2, “How satisfied with scent/odor?” are summarized. The immediate’ attributes ques was completed immediately following each treatment (trt) in Period 1 and 2. Par. specified their responses on a 6-point scale: 0: very satisfied; 1: moderately satisfied; 2: somewhat satisfied; 3: neither satisfied nor dissatisfied; 4: somewhat dissatisfied; 5; moderately dissatisfied; 6: very dissatisfied. Immediate attribute ratings were analyzed using an analysis of variance mixed model with par. as a random effect, and country, trt, period, and BL rhinitis symptomatology subgroup, and trt sequence as main effects. P-values associated with tests of immediate attribute rating scores were adjusted for multiplicity using Hochberg’s method.|Immediately following each treatment in Period 1 and 2|PP Population. Only participants responded to the question were analyzed.||Participants|||Number
639397|NCT02397915|Secondary|Number of Participants Responding to the Immediate Attributes Question Regarding Scent/Odor|Immediate attributes questionnaire was used to evaluate immediate ratings of participant for individual attributes of FF and MF nasal spray. Number of participants responding to product attributes i.e. scent/odor, using immediate attributes questionnaire, Question 1, “Did product have a scent/odor?” are summarized. The immediate attributes questionnaire was completed immediately following each treatment in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: none; 1: very mild; 2: mild; 3: neither mild nor strong; 4: slightly strong; 5; moderately strong; 6: very strong. Immediate attribute ratings were analyzed using an analysis of variance (ANOVA) mixed model with participant as a random effect, and country, treatment, period, and Baseline (BL) rhinitis symptomatology subgroup (subgrp), and treatment sequence as main effects. P-values associated with tests of immediate attribute rating scores were adjusted for multiplicity using Hochberg’s method.|Immediately following each treatment in Period 1 and 2|PP Population||Participants|||Number
639398|NCT02397915|Secondary|Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire|An overall preference questionnaire (OPQ) was used to evaluate participants’ attribute preference for nasal spray therapy for the given treatment. OPQ allows the responder three options, based on products attributes, i.e. preference for product 1; preference for product 2 and no preference. Products attributes included scent/odor, immediate taste, after taste, less drip through throat (LDTT), less run out of nose (LRON), more soothing, less irritating and urge to sneeze (UTS). The OPQ was completed by each participant approximately 4 minutes after administration of the second treatment (tmt) in Period 2. Overall participant preferences were analyzed using Prescott’s test, as approximated by a Cochran-Mantel-Haenszel (CMH) test, adjusted for country (ctry) and symptomatology (sym). All preference p-values were also adjusted for multiplicity using Hochberg’s method.|Approximately four minutes after the administration of the second treatment|PP Population||Participants|||Number
639427|NCT02395055|Primary|Area Under the Plasma Concentration-time Curve From Zero (0) Hours to 1680 Hours of Adalimumab After Single SC Injection of BCD-057/Humira.||0, 6, 24, 48, 72, 96, 120, 144, 168, 192, 336, 672, 1008, 1440, 1680 hours post-dose|All volunteers who received one adalimumab injection.||(ng/ml)*hour||Inter-Quartile Range|Median
639399|NCT02397915|Primary|Number of Participants With Overall Preference for Nasal Spray Assessed by Preference Questionnaire.|An overall preference questionnaire (OPQ) was used to evaluate participants’ preference for nasal spray therapy for the given treatments. OPQ allows the responder three options, based on products attributes, i.e. preference for product 1; preference for product 2 and no preference. The OPQ was completed by each participant approximately 4 minutes after administration of the second treatment in Period 2. Overall participant preferences were analyzed using Prescott’s test, as approximated by a Cochran-Mantel-Haenszel (CMH) test, adjusted for country and symptomatology. All preference p-values were also adjusted for multiplicity using Hochberg’s method.|Approximately four minutes after the administration of the second treatment|Per Protocol (PP) Population: comprised of all participants who completed both treatment Periods and the questionnaires associated with them.||Participants|||Number
639400|NCT02397655|Primary|Evidence of Carotid Artery or Intracranial Artery Atherosclerosis Confirmed by Vascular Ultrasonography|"By using color doppler ultrasonography, the common carotid after, internal carotid artery, vertebral artery and subclavian artery stenosis were examined and the stenosis degree of these arteries were evaluated and categorized as no stenosis, <50% stenosis, 50-69% stenosis 70-99% stenosis and occlusion.
By using transcranial color-coded sonography (TCCS) and/or transcranial doppler, the middle cerebral artery, the V4 segment of vertebral artery and basilar artery were examined and the stenosis degree of these arteries were evaluated and categorized as no stenosis, mild stenosis, medium stenosis , severe stenosis and occlusion.
Patients with one of the above arteries having >50% stenosis or occlusion evaluated by ultrasound were underwent CTA, MRA or DSA to confirmed the stenosis degree."|30 days after subjects recruitment|We provide the vessel numbers with its stenosis degree ≥50% stenosis (including occlusion).||artery numbers|||Number
639401|NCT02397564|Secondary|Patient Preference|The number of patients who preferred the fractionated laser|5 months|Those who expressed a preference.||Participants|||Count of Participants
639402|NCT02397564|Primary|Patient Observer Scar Assessment Scale (POSAS)|It uses a 10-point scoring system with a score of 1 representing a normal-appearing skin and a score of 10 representing the worst possible scar. Total scores range from 6 to 60 with the lower score indicate a better outcome.|5 months|||units on a scale||Standard Error|Mean
639403|NCT02396537|Primary|Discomfort With Intranasal Midazolam Administration|"subject self-reports pain with intranasal midazolam utilizing the Wong-Baker FACES Pain Scale. This scale is a well-established ordinal pain scale for pediatric patients. It is one score (no subscales), with a minimum score of 0 (signifying No Hurt) and a maximum score of 10 (Hurts Worst). Values between include 2 (Hurts Little Bit), 4 (Hurts Little More), 6 (Hurts Even More), and 8 (Hurts Whole Lot.). Children indicate one value/answer. Thus, a higher score indicates a worse outcome (more pain)."|immediately after administration of intranasal midazolam|||units on a scale||Inter-Quartile Range|Median
639404|NCT02396316|Secondary|Percentage of Subjects Who Had Improved Neovascularization of the Iris (NVI) Grade From Baseline to Pre-dose at Week 1|NVI were assessed in the study eye using the NVI grading systems (grade 0 to grade 4). A subject who shows the improvement by at least one grade is considered to be improved. Percentage of subjects who had improved NVI grade was reported.|From baseline to pre-dose at Week 1|FAS||Percentage of participants|||Number
639405|NCT02396316|Primary|Change in Intraocular Pressure (IOP) From Baseline to Pre-dose at Week 1|It compared the change in IOP from baseline to pre-dose at Week 1 between the aflibercept group vs the sham group.|From baseline to pre-dose at Week 1|FAS: The Full Analysis Set (FAS) included all randomized subjects who have received any study drug (including sham injection) and had had a baseline and at least one post-baseline IOP measurement on a posterior date. The FAS was analyzed as randomized.||mmHg||Standard Deviation|Mean
639406|NCT02396160|Secondary|Stress Incontinence Frequency|Stress incontinence as defined by number of episodes of incontinence per day related to stress, recorded in a validated urinary diary|8 weeks|Analysis includes participants who met the criteria for this outcome being stress incontinence frequency ≥1 per day at baseline. Please note that not all participants in this study met the criteria for all outcomes, hence numbers in each section may seem incongruent with total study participants.||Number of stress incontinence episodes||95% Confidence Interval|Mean
639407|NCT02396160|Primary|Nocturia Frequency|Night time urinary frequency as defined as the number of voluntary nocturnal micturition's per day recorded in a validated urinary diary|8 weeks|Analysis includes participants who met the criteria for this outcome being nocturnal frequency ≥2 per day at baseline. Please note that not all participants in this study met the criteria for all outcomes, hence numbers in each section may seem incongruent with total study participants.||number of nocturnal micturitions||95% Confidence Interval|Mean
639408|NCT02396160|Secondary|Urge Incontinence Frequency|Urge incontinence as defined by number of incontinence episodes per day resulting from urinary urgency, recorded in a validated urinary diary|8 weeks|Analysis includes participants who met the criteria for this outcome being urge incontinent frequency ≥1 per day at baseline. Please note that not all participants in this study met the criteria for all outcomes, hence numbers in each section may seem incongruent with total study participants.||number of urge incontinence episodes||95% Confidence Interval|Mean
639409|NCT02396160|Secondary|Urinary Urgency Frequency|Urinary urgency as defined by number of urgency episodes per day recorded in a validated urinary diary|8 weeks|Analysis includes participants who met the criteria for this outcome being urgency urination frequency ≥1 per day at baseline. Please note that not all participants in this study met the criteria for all outcomes, hence numbers in each section may seem incongruent with total study participants.||number of urgency episodes||95% Confidence Interval|Mean
639410|NCT02396160|Primary|Day Urinary Frequency|Day urinary frequency as defined as the number of voluntary diurnal micturitions per day, recorded in a validated urinary diary|8 weeks|Analysis includes participants who met the criteria for this outcome being day urination frequency ≥10 daytime micturitions per day at baseline. Please note that not all participants in this study met the criteria for all outcomes, hence numbers in each section may seem incongruent with total study participants.||number of diurnal micturitions per day||95% Confidence Interval|Mean
639411|NCT02396147|Secondary|Oral Clearance (CL/F) for TAK-385||Days 1, 11, and 21 predose and at multiple time points (up to 120 hours) post-dose|Pharmacokinetic (PK)-Evaluable population included participants who had sufficient dosing and PK data for analysis, and who did not receive any excluded medications.||liters (L)/hr||Geometric Coefficient of Variation|Geometric Mean
639445|NCT02394457|Primary|Headache Pain Score|Numerical 0-10 (0 no pain, 10 worst pain)|1 day post procedure|||units on a scale||Standard Deviation|Mean
639417|NCT02396147|Secondary|Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events. A SAE is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.|From Day 1 to 30 days after the last dose of study drug (Up to 51 days total)|Safety population included all participants who received at least 1 dose of study drug.||percentage of participants|||Number
639418|NCT02396147|Primary|AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-385||Days 1, 11, and 21 predose and at multiple time points (up to 120 hours) post-dose|PK-Evaluable population included participants who had sufficient dosing and PK data for analysis, and who did not receive any excluded medications.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
639419|NCT02396147|Primary|AUC(0-120): Area Under the Plasma Concentration-Time Curve From Time 0 to 120 Hours Postdose for TAK-385||Days 1, 11, and 21 predose and at multiple time points (up to 120 hours) post-dose|PK-Evaluable population included participants who had sufficient dosing and PK data for analysis, and who did not receive any excluded medications.||ng•hr/mL||Geometric Coefficient of Variation|Geometric Mean
639420|NCT02396147|Primary|Cmax: Maximum Observed Plasma Concentration for TAK-385||Days 1, 11, and 21 predose and at multiple time points (up to 120 hours) post-dose|Pharmacokinetic (PK)-Evaluable population included participants who had sufficient dosing and PK data for analysis, and who did not receive any excluded medications.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
639425|NCT02395536|Primary|Untoward Event Rate Associated With LINQ™ Insertions Performed|"Demonstrate that the untoward event rate associated with Reveal LINQ™ insertions performed in-office or in the traditional hospital setting (operating room, cardiac catheterization or EP laboratory) are comparable.
Untoward events are a composite of unsuccessful Reveal LINQ™ or complications related to the Reveal LINQ™ insertion procedure or system."|3 Months post insertion|Subjects exiting prematurely (prior to 3-month visit) without an untoward event were excluded from primary analysis. There were 7 excluded from the In office arm (2 deaths unrelated to the REVEAL LINQ and 5 premature exits) and 4 excluded from the traditional hospital setting arm (all 4 due to premature exit)||Participants|||Count of Participants
639426|NCT02395302|Primary|Number of Participants Who Agreed With Tolerance and Comfort Questionnaire Items After Using a Dual Action Pneumatic Compression Device|"A questionnaire that was completed after receiving four weeks of treatment from a dual action pneumatic compression device. Questions listed below:
The device was comfortable to wear during Sustained Compression Mode.
The device was comfortable to wear during Intermittent Compression Mode.
The noise from the device was not bothersome.
The device was easy to put on.
The device was easy to take off.
The device was easy to use.
The device was light-weight and portable.
The use of the device helped my wound heal faster.
I would use the device again on another wound in the future.
Since using the device, my quality of sleep has improved.
It was a burden to come to the wound care clinic for my dressing changes.
The use of the device did not restrict many of my normal activities.
The device was cumbersome and interfered with my mobility.
I was able to work while being treated with the device."|4 weeks|"The Tolerance and Comfort questionnaire was completed at study exit by 16 participants (13 of the 16 total subjects completed the study, 2 were withdrawn by their site's Investigator, and 1 voluntarily withdrew).
Six participants were not employed during the time of questionnaire completion. Question 14 was not applicable to these participants."||Participants|||Count of Participants
639446|NCT02393950|Secondary|Quantitative EEG|Quantitative analysis of EEG|Pre-dose and at 1, 6 and 10 h post dose at each dose level||||||
639430|NCT02394925|Primary|Proportion of Successful Contact Lens Wearers|"Proportion of Successful contact lens wearers is based on a subject's responses to two questionnaire items, Overall Quality of Vision and Overall Comfort. Each item uses a 6 response like-rt scale (0= Not Applicable, 1=Excellent, 2=Very Good, 3=Good, 4=Fair and 5=Poor). The data from each item was dichotomized into two groups. If a subject responded Excellent, Very Good or Good then the response=1, otherwise the response=0. The proportion of subjects with response=1 was reported as the proportion of successful contact lens wearers."|2 months post wear|Subjects that completed all study visits without a major protocol deviation.||Proportion of Subjects|||Number
639431|NCT02394808|Primary|Subjective Overall Quality of Vision|Subjective Overall quality of Vision was evaluated using the Contact Lens User Experience Comfort scores (CLUE). CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.|11 days post fit|Subjects that completed all study visits without a major protocol deviation.||units on a scale||Standard Deviation|Mean
639432|NCT02394808|Primary|Subjective Overall Comfort|Subjective Overall Comfort was evaluated using the Contact Lens User Experience Comfort scores (CLUE). CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.|11 days Post fit|Subjects that completed all study visits without a major protocol deviation.||units on a scale||Standard Deviation|Mean
639433|NCT02394756|Primary|Subjective Overall Quality of Vision|Subjective Overall quality of vision was evaluated using the Contact Lens User Experience Comfort scores (CLUE). CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. Scores range 0-120.|1-Day Follow-up|Subjects that completed all study visits without a major protocol deviation.||units on a scale||Standard Deviation|Mean
639434|NCT02394756|Primary|Subjective Overall Comfort|Subjective Overall Comfort was evaluated using the Contact Lens User Experience Comfort scores (CLUE). CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. Scores range 0-120.|1-Day Follow-up|Subjects that completed all study visits without a major protocol deviation.||units on a scale||Standard Deviation|Mean
639435|NCT02394665|Secondary|Patterns of Failure in Study Participants Post-Protocol Therapy|Patterns of Failure will be assessed by determining the number of failures that arise in-field compared to the number that arise out–of-field. In-field failure will be defined as those where greater than 80% of the recurrence volume was encompassed by the 95% prescription isodose line. In addition, we will also describe failures by three types: unifocal, multifocal and diffuse (multicentric including leptomeningeal dissemination).|Up to 2 years|Data were not analyzed due to insufficient number of evaluable subjects. Only one subject enrolled who was later withdrawn by the Investigator prior to assignment to any treatment group or receiving any protocol therapy.|||||
639436|NCT02394665|Secondary|Change in Quality of Life From Baseline in Study Participants|Change in quality of life during radiation and across the longitudinal progression-free interval compared to baseline. Change of quality of life will be assessed and scored via the FACT-Br behavioral questionnaire.|Up to 2 years|Data were not analyzed due to insufficient number of evaluable subjects. Only one subject enrolled who was later withdrawn by the Investigator prior to assignment to any treatment group or receiving any protocol therapy.|||||
639437|NCT02394665|Secondary|Rate of Grade 3 or Higher Toxicity as a a Consequence of Study Therapy.|Rate of Grade 3 of Higher Toxicity in study participants as a consequence of study therapy.|2 years|Data were not analyzed due to insufficient number of evaluable subjects. Only one subject enrolled who was later withdrawn by the Investigator prior to assignment to any treatment group or receiving any protocol therapy.|||||
639438|NCT02394665|Secondary|Rate of Progression-Free Survival (PFS) in Study Patients|Rate of progression-free survival in study participants. Progression-free survival (PFS) is defined as the time elapsed from the start of study treatment to the date of documented progression events. For progression-free patients (without progression events), PFS will be censored at the last date of documented PF status.|Up to 2 years|Data were not analyzed due to insufficient number of evaluable subjects. Only one subject enrolled who was later withdrawn by the Investigator prior to assignment to any treatment group or receiving any protocol therapy.|||||
639439|NCT02394665|Primary|Rate of Overall Survival (OS) in Study Patients|The efficacy of 3D MRSI-guided, dose escalated radiation in newly diagnosed glioblastoma (GBM) patients as measured by overall survival (OS). Overall survival (OS) is defined as the time elapsed from the start of study treatment until death. Surviving patients (including patients lost to follow up) will be censored at the date of last contact.|Up to 2 years|Data were not analyzed due to insufficient number of evaluable subjects. Only one subject enrolled who was later withdrawn by the Investigator prior to assignment to any treatment group or receiving any protocol therapy.|||||
639440|NCT02394457|Secondary|Functioning Score|Functional score 0-10 (0 being able to function all tasks of daily living, 10 not able to complete ADLs|7 day post procedure|||units on a scale||Standard Deviation|Mean
639441|NCT02394457|Secondary|Functioning Score|Functional score 0-10 (0 being able to function all tasks of daily living, 10 not able to complete ADLs|3 day post procedure|||units on a scale||Standard Deviation|Mean
639442|NCT02394457|Secondary|Functioning Score|Functional score 0-10 (0 being able to function all tasks of daily living, 10 not able to complete activities of daily living (ADLs)|1 day post procedure|||units on a scale||Standard Deviation|Mean
639443|NCT02394457|Primary|Headache Pain Score|Numerical 0-10 (0 no pain, 10 worst pain)|7 days post procedure|||units on a scale||Standard Deviation|Mean
639449|NCT02393950|Secondary|Effect of ODM-106 on Growth Hormone Levels|Growth hormone levels (Cmax) in serum after single oral dosing with either ODM-106 Capsule B, ODM-106 Capsule A or placebo.|Predose and 1, 2, 3,4, 6 and 8 hours post dose at each dose level.|Only timepoints 2 - 6h evaluated.||ng/ml||Standard Deviation|Geometric Mean
639450|NCT02393950|Secondary|Metabolite Screening in Plasma and Urine|Metabolite screening in plasma and urine after single dosing|Plasma samples at pre-dose and 15, 30 and 45 min, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose at each dose level. Urine samples, pre-dose and for 24 hours post dose at each dose level||||||
639451|NCT02393950|Secondary|Elimination Half-life of ODM-106|Elimination half-life of ODM-106 after single dosing of either Capsule B or Capsule A|Pre-dose and 15, 30 and 45 min, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose at each dose level.|||h||Standard Deviation|Mean
639452|NCT02393950|Secondary|Time to Peak Plasma Concentration (Tmax) of ODM-106|tmax of ODM-106 after single oral dosing of Capsule B or Capsule A|Pre-dose and 15, 30 and 45 min, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose at each dose level|||h||Full Range|Mean
639453|NCT02393950|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC) of ODM-106|AUC of ODM-106 after single oral dosing of either Capsule B or Capsule A.|Pre-dose and 15, 30 and 45 min, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose at each dose level. Urine sampling, pre-dose and for 24 hours post dose at each dose level|||h*ng/ml||Standard Deviation|Mean
639454|NCT02393950|Secondary|Peak Plasma Concentration (cMax) of ODM-106|cMax of ODM-106 after single dosing of either Capsule B or Capsule A|Pre-dose and 15, 30 and 45 min, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose at each dose level.|||ng/ml||Standard Deviation|Mean
639455|NCT02393950|Primary|Number of Participants With Adverse Events as a Measure of Safety. Number of Participants With Adverse Events Related to Tolerability.|Clinically relevant changes from baseline in safety laboratory assessments (haematology, clinical chemistry, urinalysis), vital signs (pulse and heart rate), 12 lead electrocardiograms, Holter electrocardiograms, telemetry, physical examination.|From screening up to 16 weeks|||subjects affected|||Number
639456|NCT02393677|Other Pre-specified|Complications||2 hours||||||
639457|NCT02393677|Other Pre-specified|Haemodynamic Changes||8 hours||||||
639458|NCT02393677|Secondary|Duration of Motor Block||6 hours||||||
639459|NCT02393677|Secondary|Onset of Motor Block||30minutes||||||
639460|NCT02393677|Secondary|Onset of Sensory Block||20 minutes||||||
639461|NCT02393677|Primary|Duration of Analgesia||upto 8 hours|||minutes||Standard Deviation|Mean
639462|NCT02393547|Secondary|BMI|Change in BMI from baseline to week 12|12 weeks|subjects (N=10) who met criteria for prolonged smoking abstinence at week 12||kg/m^2||Standard Deviation|Mean
639463|NCT02393547|Secondary|Smoking Abstinence Rates|prolonged smoking abstinence at week 12|12 weeks|||Participants|||Count of Participants
639464|NCT02393547|Secondary|Waist Circumference|Change in waist circumference from baseline to week 12|12 Weeks|subjects (n=10) who met criteria for prolonged smoking abstinence at week 12||cm||Standard Deviation|Mean
639465|NCT02393547|Primary|Post Cessation Weight Change|change in weight from baseline to week 12|12 weeks|subjects (n=10) who met criteria for prolonged smoking abstinence at week 12||kg||Standard Deviation|Mean
639466|NCT02392767|Other Pre-specified|Change in Prothrombin Time Between the Visit at Start of Supplementation Phase and the Visit on the Final Day of the 4 Week Supplementation Phase|"Prothrombin Time was assessed at the visit at start of the supplementation phase and the visit at the end of the 4 week supplementation phase. Blood coagulability is expressed in units of Quick value. In this case, the measured prothrombin time is expressed in relation to the coagulation time of a healthy person. The value obtained is the percentage of the standard Quick value. In a person not receiving oral anticoagulation the normal Quick value is between 70 and 100%. The longer the patient's coagulation time, the lower the Quick value"|Intervention period of 4 weeks|||Percentage of the standard Quick value||95% Confidence Interval|Mean
639467|NCT02392767|Secondary|Glycated Hemoglobin (HbA1c) Determined on the Final Day of the 4 Week Intervention Period.|Glycated hemoglobin (HbA1c) as percentage of total hemoglobin was determined on the final day of the 4 week intervention period.|After intervention period of 4 weeks|||percentage of total hemoglobin||95% Confidence Interval|Mean
639468|NCT02392767|Secondary|Asymmetric Dimethyl Arginine (ADMA) Level Determined on the Final Day of the 4 Week Intervention Period.|ADMA (asymmetric dimethyl arginine) was determined on the final day of the 4 week intervention period. Samples were analyzed batch wise using an enzymatic test|After intervention period of 4 weeks|||µmol/l||95% Confidence Interval|Mean
639469|NCT02392767|Secondary|Homocystein Level Determined on the Final Day of the 4 Week Intervention Period.|"Homocystein level in µmol/l was determined on the final day of the 4 week intervention period.
The first supplementation period started at visit one and lasted for 4 weeks. It was followed by a wash out phase of 8 weeks and subsequently by a second supplementation phase of 4 weeks (cross-over design)"|After intervention period of 4 weeks|||μmol/l||95% Confidence Interval|Mean
639470|NCT02392767|Secondary|Mean of Blood Pressure Measured Daily at the Last 7 Days of the 4 Week Intervention Period.|The mean of daily systolic and diastolic blood pressure measured daily at the last 7 days of the 4 week intervention period. Measurements were performed by subjects at home and were taken on the left arm, after at least 10 minutes of rest, in a sitting position.|Intervention period of 4 weeks|||mmHg||95% Confidence Interval|Mean
639471|NCT02392767|Primary|"Change in Endothelial Function Between the Visit at Start of Supplementation Phase and the Visit on the Final Day of the 4 Week Supplementation Phase (Delta lnRHI)"|"Endothelial function was determined with the EndoPAT™ method (non-invasive Peripheral Aterial Tonometry) using a reactive hyperemia procedure. The outcome measure is the change in endothelial function between the visit at start of the supplementation phase and the visit on the final day of the 4 week supplementation phase. The endothelial function is determined as the natural log of the Reactive Hyperemia Index (lnRHI) which is the post-to-pre occlusion peripheral arterial tonometry signal ratio in the occluded side, relative to the same ratio in the control side, corrected for baseline vascular tone of the occluded side.
Normal lnRHI > 0.51, Abnormal lnRHI < 0.51"|Intervention period of 4 weeks|||Delta lnRHI [Index]||95% Confidence Interval|Mean
639655|NCT02387502|Primary|Time of Intubation|Time of intubation is defined as the time from passing the device beyond the incisors to the confirmation of endotracheal tube placement by square wave capnograph tracings.|up to 10 minutes|||seconds||Standard Deviation|Mean
639472|NCT02392247|Primary|Clot Stiffness|Coagulation Function assessed at 4 time points (baseline, during bypass, 10 minutes after heparin reversal just prior to bypass weaning, and off-bypass before transfer to the ICU) over the course of cardiac surgery and bypass until patient ICU transfer|1 day|Matched paired blood samples evaluating coagulation function by two methods (TEG, SEER) for each patient at each of 4 time points [baseline, during bypass, 10 minutes after heparin reversal just prior to bypass weaning, and off-bypass before transfer to the ICU]||hPa|Participants|Standard Deviation|Mean
639473|NCT02392247|Primary|Clot Time|Coagulation Function assessed at 4 time points [baseline, during bypass, 10 minutes after heparin reversal just prior to bypass weaning, and off-bypass before transfer to the ICU] over the course of cardiac surgery until patient ICU transfer|1 day|Matched paired blood samples evaluating coagulation function by two methods (TEG, SEER) obtained from each patient at each sampling time (baseline, during bypass, 10 minutes after heparin reversal just prior to bypass weaning, and off-bypass before transfer to the ICU)||min|Participants|Standard Deviation|Mean
639474|NCT02392208|Secondary|AUC24-48 of Telavancin|Area under the telavancin concentration-time curve 24-48 hours from start of infusion|At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48|||mcg*h/mL||Standard Deviation|Mean
639475|NCT02392208|Secondary|AUC0-24 of Telavancin|Area under the telavancin concentration-time curve 0-24 hours from start of infusion|At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48|||mcg*h/mL||Standard Deviation|Mean
639476|NCT02392208|Primary|t1/2 of Telavancin|Half-life of telavancin|At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48|||hours||Standard Deviation|Mean
639477|NCT02392208|Primary|CLobs of Telavancin|Observed clearance of telavancin|At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48|||mL/h/kg||Standard Deviation|Mean
639478|NCT02392208|Primary|Vss of Telavancin|Volume of distribution of telavancin at steady state|At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48|||mL/kg||Standard Deviation|Mean
639479|NCT02392208|Primary|Cmax of Telavancin|Peak concentration of telavancin|At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48|||mcg/mL||Standard Deviation|Mean
639480|NCT02391714|Secondary|Baseline Mean Pain Scores|Baseline pain scores prior to IUD insertion is assessed using a 0-100mm VAS with anchors 0 equals no pain and 100 equals worst pain imaginable. The minimal clinically important difference in pain for this study was set at 15mm.|Before the IUD insertion procedure|||units on a scale||Standard Deviation|Mean
639481|NCT02391714|Secondary|Patient Satisfaction With Over-all Pain Control With IUD Insertion - VAS|Satisfaction will be measured using a 100mm Visual Analog Scale (VAS), with anchors 0mm for very satisfied and 100mm for very dissatisfied.|Prior to clinic discharge, which is an average of 15 minutes after the procedure|||units on a scale||Standard Deviation|Mean
639482|NCT02391714|Primary|Mean Maximum Procedural Pain Scores|Pain is assessed using a 0-100mm VAS with anchors 0 equals no pain and 100 equals worst pain imaginable. The minimal clinically important difference in pain for this study was set at 15mm.|2 minutes after the procedure.|||units on a scale||Standard Deviation|Mean
639483|NCT02391311|Secondary|Change in Driving Simulator Performance|Driving Simulator Performance: Center lane crossings (a count of how many times an individual crosses the centerline during the entire simulator drive). A difference score was taken between time 2 and time 1 and compared between treatment groups (sham condition and tDCS condition). A negative difference score indicates that fewer center line crossings were made at time 2 than time 1, while positive difference scores indicate the opposite direction, and scores of 0 represent no change.|baseline, 6 week posttest|While n=33 was the final sample used for the primary outcome analyses, n=30 was used for the secondary outcome as 3 subjects did not have available simulator data.||Times crossing center lane||95% Confidence Interval|Mean
639484|NCT02391311|Primary|Change in the Processing of Speed|Computerized and paper & pencil processing speed measures were used to evaluate this outcome. The Letter and Pattern Comparison Tasks are traditional paper and pencil (SOP) measures. Specifically, they assess perceptual speed. In Letter Comparison subjects are shown three sets of 32 pairs of letters containing 3, 6, or 9 segments. The participants are instructed to decide whether the patterns between the pairs are the same or different within each set, with a time limit of 20 sec per set. Pattern Comparison also presents three sets of 32 pairs of patterns with 3, 6, or 9 line segments. Similarly, participants are instructed to decide whether the patterns are the same or different within the 20 sec time limit. For each measure, the total score is the number of correct answers from all three sets. Larger scores indicate better reasoning and cognitive functioning. In this study scores from Letter and Pattern Comparison were combined for a total Letter/Pattern Score.|baseline, 6 week posttest|n=33 subjects were included in final analyses. Of the 37 that completed the study, 4 were deemed ineligible after they had completed the study due to confirmation with medical records they had conditions that may affect neurocognition (stroke and schizophrenia) although they self reported on the screen they did not have these conditions.||units on a scale||Full Range|Mean
639485|NCT02391038|Secondary|Phase 2- Number of Participants With ATA in Serum|Blood samples were to be collected predose to evaluate ATA.|Baseline up to approximately 1 year|Data was not reported for this measure as Phase 2 was not initiated, due to study termination during the dose-escalation portion of phase 1 consistent with the findings that preliminary PK and overall clinical data demonstrated compelling similarity between Western and Asian participant populations.|||||
639486|NCT02391038|Secondary|Phase 2- Guanylyl Cyclase C (GCC) H-score Assessed by Immunohistochemistry (IHC)|The H-score is a method of assessing the extent of nuclear immunoreactivity, applicable to steroid receptors. The score is obtained by the formula: 3 * percentage of strongly staining nuclei + 2 * percentage of moderately staining nuclei + percentage of weakly staining nuclei, giving a range of 0 to 300. The 600 H-score is based on the sum of the 0 to 300 H-score for cytoplasmic staining and the 0 to 300 H-score for apical staining|Baseline up to approximately 1 year|Data was not reported for this measure as Phase 2 was not initiated, due to study termination during the dose-escalation portion of phase 1 consistent with the findings that preliminary PK and overall clinical data demonstrated compelling similarity between Western and Asian participant populations.|||||
639487|NCT02391038|Secondary|Phase 2- Tumor Size Reduction|For each participant, the best percentage of tumor reduction from baseline in the sum of the diameter was calculated.|Baseline up to approximately 1 year|Data was not reported for this measure as Phase 2 was not initiated, due to study termination during the dose-escalation portion of phase 1 consistent with the findings that preliminary PK and overall clinical data demonstrated compelling similarity between Western and Asian participant populations.|||||
639488|NCT02391038|Secondary|Phase 2- Plasma Concentration of MLN0264||Day 1 of every cycle (up to 1 year): predose and at multiple time points(up to 336 hours) post-dose|Data was not reported for this measure as Phase 2 was not initiated, due to study termination during the dose-escalation portion of phase 1 consistent with the findings that preliminary PK and overall clinical data demonstrated compelling similarity between Western and Asian participant populations.|||||
639489|NCT02391038|Secondary|Phase 2- Overall Survival (OS)|OS is defined as the time from the date of first study drug administration to the date of death. Participants without documentation of death at the time of analysis were censored at the date when they were last known to be alive.|Baseline up to EOT thereafter every 12 weeks until death or the start of subsequent antineoplastic therapy, or 6 months after discontinuation from treatment, whichever occurs first (total duration of assessment up to 1.5 years)|Data was not reported for this measure as Phase 2 was not initiated, due to study termination during the dose-escalation portion of phase 1 consistent with the findings that preliminary PK and overall clinical data demonstrated compelling similarity between Western and Asian participant populations.|||||
639490|NCT02391038|Secondary|Phase 2- Disease Control Rate (DCR)|DCR is defined as Complete Response (CR) rate + Partial Response (PR) rate + stable disease (SD) rate with a minimum of 12 weeks' duration. Duration of SD is defined as the time from the date of first study drug administration to the date of first documentation of disease progression for participants who achieved SD as the best overall response. CR: disappearance of all target lesions; PR: at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; PD:at least a 20% increase in the sum of the LD of target lesions, taking the smallest sum LD recorded as reference since the treatment started or the appearance of one or more new lesions) and SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|Phase 2: Day 21 of every other cycle (Cycle 2, 4, 6, 8) up to EOT (approximately 1 year)|Data was not reported for this measure as Phase 2 was not initiated, due to study termination during the dose-escalation portion of phase 1 consistent with the findings that preliminary PK and overall clinical data demonstrated compelling similarity between Western and Asian participant populations.|||||
639491|NCT02391038|Secondary|Phase 2- Duration of Response (DOR)|DOR is defined as the time from the date of first documentation of a confirmed response to the date of first documentation of Progressive Disease (PD). Responders without documentation of PD were censored at the last response assessment that was stable disease or better. CR: disappearance of all target lesions; PR: at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD and PD:at least a 20% increase in the sum of the LD of target lesions, taking the smallest sum LD recorded as reference since the treatment started or the appearance of one or more new lesions.|Day 21 of every other cycle (Cycle 2, 4, 6, 8) up to EOT (approximately 1 year)|Data was not reported for this measure as Phase 2 was not initiated, due to study termination during the dose-escalation portion of phase 1 consistent with the findings that preliminary PK and overall clinical data demonstrated compelling similarity between Western and Asian participant populations.|||||
639492|NCT02391038|Secondary|Phase 2- Progression-free Survival (PFS)|PFS is defined as the time from the date of first study drug administration to the date of first documentation of progressive disease or death. For a participant who has not progressed and is last known to be alive, PFS was censored at the last response assessment that was stable disease or better. PD:at least a 20% increase in the sum of the LD of target lesions, taking the smallest sum LD recorded as reference since the treatment started or the appearance of one or more new lesions.|Baseline up to EOT, thereafter every 12 weeks until the occurrence of PD, the start of subsequent antineoplastic therapy, or 6 months after discontinuation from treatment, whichever occurs first (total duration of assessment up to 1.5 years)|Data was not reported for this measure as Phase 2 was not initiated, due to study termination during the dose-escalation portion of phase 1 consistent with the findings that preliminary PK and overall clinical data demonstrated compelling similarity between Western and Asian participant populations.|||||
639493|NCT02391038|Secondary|Phase 2- Number of Participants With Clinically Significant Change From Baseline in Vital Signs|Vital signs include body temperature (oral or tympanic measurement), sitting blood pressure (after the participant has rested for at least 5 minutes), and pulse (beats per minute [bpm]).|Phase 2: Baseline up to 30 days after last dose of study drug (approximately 1 year)|Data was not reported for this measure as Phase 2 was not initiated, due to study termination during the dose-escalation portion of phase 1 consistent with the findings that preliminary PK and overall clinical data demonstrated compelling similarity between Western and Asian participant populations.|||||
639494|NCT02391038|Secondary|Phase 2- Number of Participants With Markedly Abnormal Laboratory Values|The number of participants with any markedly abnormal standard safety laboratory values collected throughout study. Laboratory assessment includes serum chemistry, hematology, urine analysis and coagulation.|Phase 2: Baseline up to 30 days after last dose of study drug (approximately 1 year)|Data was not reported for this measure as Phase 2 was not initiated, due to study termination during the dose-escalation portion of phase 1 consistent with the findings that preliminary PK and overall clinical data demonstrated compelling similarity between Western and Asian participant populations.|||||
639495|NCT02391038|Secondary|Phase 2- Percentage of Participants Who Experience at Least One SAE||Phase 2: Baseline up to 30 days after last dose of study drug (approximately 1 year)|Data was not reported for this measure as Phase 2 was not initiated, due to study termination during the dose-escalation portion of phase 1 consistent with the findings that preliminary PK and overall clinical data demonstrated compelling similarity between Western and Asian participant populations.|||||
639496|NCT02391038|Secondary|Phase 2- Percentage of Participants Who Experience at Least One TEAE||Phase 2: Baseline up to 30 days after last dose of study drug (approximately 1 year)|Data was not reported for this measure as Phase 2 was not initiated, due to study termination during the dose-escalation portion of phase 1 consistent with the findings that preliminary PK and overall clinical data demonstrated compelling similarity between Western and Asian participant populations.|||||
639509|NCT02391038|Primary|Phase 1: Cycle 1- Cmax: Maximum Observed Plasma Concentration for Monomethyl Auristatin E (MMAE)||Day 1 of Cycle 1: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MMAE concentration time data to permit reliable estimation of the PK parameters.||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
641661|NCT02299869|Primary|Comfort|Participant's subjective rating for comfort. (Scale 0-10, 0=poor, 10=excellent).|Baseline|||units on a scale||Standard Deviation|Mean
639497|NCT02391038|Secondary|Phase 1- Disease Response Based on the Investigator’s Assessment|Disease response was based on the investigator’s assessment using the modified RECIST version 1.1 guidelines. Evaluation of target lesions included CR (Disappearance of all target lesions),PR(at least a 30% decrease in the sum of the LD of target lesions),Progressive disease (PD:at least a 20% increase in the sum of the LD of target lesions, taking the smallest sum LD recorded as reference since the treatment started or the appearance of one or more new lesions) and Stable disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD).Evaluation of Non target Lesions included CR (disappearance of all non target lesions and normalization of tumor marker level), Incomplete response/SD (Persistence of 1 or more non target lesions and/or maintenance of tumor marker level above the normal limits) and PD(Appearance of 1 or more new lesions and/or unequivocal progression of existing non target lesions).|Phase 1: Day 21 of every other cycle (Cycle 2, 4, 6, 8) up to End of treatment (EOT) (Cycle10 or week 30)|The Response-Evaluable population is defined as all participants with measurable disease who receive at least 1 dose of MLN0264 and have at least 1 post baseline response assessment.||participants|||Number
639498|NCT02391038|Secondary|Phase 1- Number of Participants With Antitherapeutic Antibodies (ATAs)|Blood samples was collected predose to evaluate ATA. Data was collected only for limited period due to early termination of the study.|Day 1 of Cycle 1, 2, 3, 4: predose|Safety population included all participants who received any amount of study drug.||participants|||Number
639499|NCT02391038|Primary|Phase 2- Overall Response Rate|ORR is the percentage of participants with complete response [CR] + partial response [PR]) based on modified Response Evaluation Criteria in Solid Tumors (RECIST). Overall response rate (CR + PR) based on modified RECIST version 1.1 guidelines. CR: Disappearance of all target lesions and PR: at least a 30 percentage (%) decrease in the sum of the longest diameter (LD) of target lesions, taking the baseline sum LD as reference. All measurable lesions up to a maximum of 2 lesions per organ, 5 lesions in total representative of all involved organs were identified as target lesions at baseline. Target lesions were selected on the basis of size (longest lesions) and suitability for reproducible repeated measurements.|Baseline until end of study treatment (approximately 1 year)|Data was not reported for this measure as Phase 2 was not initiated, due to study termination during the dose-escalation portion of phase 1 consistent with the findings that preliminary PK and overall clinical data demonstrated compelling similarity between Western and Asian participant populations.|||||
639500|NCT02391038|Primary|Phase 1: Cycle 2- Ctrough: Observed Concentration Measured at the End of a Dosing Interval for MMAE||Day 1 of Cycle 2: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MMAE concentration time data to permit reliable estimation of the PK parameters where Cycle2 Day1 PK assessment were available. Data is not reported for MLN0264 1.2 mg/kg arm because none of the participants had data evaluable for this measure.||ng/mL||Standard Deviation|Geometric Mean
639501|NCT02391038|Primary|Phase 1: Cycle 1- Ctrough: Observed Concentration Measured at the End of a Dosing Interval for MMAE||Day 1 of Cycle 1: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MMAE concentration time data to permit reliable estimation of the PK parameters where Cycle 1 Day 1 PK assessment were available.||ng/mL||Standard Deviation|Geometric Mean
639502|NCT02391038|Primary|Phase 1: Cycle 2- AUCint: Area Under the Serum/Plasma Concentration-time Curve From Time 0 to End of the 21-day Dosing Interval (AUCint) for MMAE||Day 1 of Cycle 2: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MMAE concentration time data to permit reliable estimation of the PK parameters where Cycle2 Day1 PK assessment were available. Data is not reported for MLN0264 1.2 mg/kg arm because none of the participants had data evaluable for this measure.||day*ng/mL||Standard Deviation|Geometric Mean
639503|NCT02391038|Primary|Phase 1: Cycle 1- AUCint: Area Under the Serum/Plasma Concentration-time Curve From Time 0 to End of the 21-day Dosing Interval (AUCint) for MMAE||Day 1 of Cycle 1: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MMAE concentration time data to permit reliable estimation of the PK parameters where Cycle 1 Day 1 PK assessment were available.||day*ng/mL||Standard Deviation|Geometric Mean
639504|NCT02391038|Primary|Phase 1: Cycle 2- AUCinf: Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) for MMAE||Day 1 of Cycle 2: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MMAE concentration time data to permit reliable estimation of the PK parameters where Cycle2 Day1 PK assessment were available. Data is not reported for MLN0264 1.2 mg/kg arm because none of the participants had data evaluable for this measure.||day*ng/mL||Standard Deviation|Geometric Mean
639505|NCT02391038|Primary|Phase 1: Cycle 1- AUCinf: Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) for MMAE||Day 1 of Cycle 1: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MMAE concentration time data to permit reliable estimation of the PK parameters where Cycle 1 Day 1 PK assessment were available.||day*ng/mL||Standard Deviation|Geometric Mean
639506|NCT02391038|Primary|Phase 1: Cycle 2- Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for MMAE||Day 1 of Cycle 2: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MMAE concentration time data to permit reliable estimation of the PK parameters where Cycle 2 Day 1 PK assessment were available.||day||Full Range|Median
639507|NCT02391038|Primary|Phase 1: Cycle 1- Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for MMAE||Day 1 of Cycle 1: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MMAE concentration time data to permit reliable estimation of the PK parameters.||day||Full Range|Median
639508|NCT02391038|Primary|Phase 1: Cycle 2- Cmax: Maximum Observed Plasma Concentration for MMAE||Day 1 of Cycle 2: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MMAE concentration time data to permit reliable estimation of the PK parameters where Cycle 2 Day 1 PK assessment were available.||ng/mL||Standard Deviation|Geometric Mean
639510|NCT02391038|Primary|Phase 1: Cycle 2- Ctrough: Observed Concentration Measured at the End of a Dosing Interval for TAb||Day 1 of Cycle 2: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient TAb concentration time data to permit reliable estimation of the PK parameters where Cycle 2 Day1 PK assessment were available. Data is not reported for MLN0264 1.2 mg/kg arm because none of the participants had data evaluable for this measure.||mcg/mL||Standard Deviation|Geometric Mean
639511|NCT02391038|Primary|Phase 1: Cycle 1- Ctrough: Observed Concentration Measured at the End of a Dosing Interval for TAb||Day 1 of Cycle 1: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient TAb concentration time data to permit reliable estimation of the PK parameters where Cycle 1 Day1 PK assessment were available. Data is not reported for MLN0264 1.2 mg/kg arm because none of the participants had data evaluable for this measure.||mcg/mL||Standard Deviation|Geometric Mean
639512|NCT02391038|Primary|Phase 1: Cycle 2- AUCint: Area Under the Serum/Plasma Concentration-time Curve From Time 0 to End of the 21-day Dosing Interval (AUCint) for TAb||Day 1 of Cycle 2: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient TAb concentration time data to permit reliable estimation of the PK parameters where Cycle 2 Day1 PK assessment were available. Data is not reported for MLN0264 1.2 mg/kg arm because none of the participants had data evaluable for this measure.||day*mcg/mL||Standard Deviation|Geometric Mean
639513|NCT02391038|Primary|Phase 1: Cycle 1- AUCint: Area Under the Serum/Plasma Concentration-time Curve From Time 0 to End of the 21-day Dosing Interval (AUCint) for TAb||Day 1 of Cycle 1: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient TAb concentration time data to permit reliable estimation of the PK parameters where Cycle 1 Day 1 PK assessment were available.||day*mcg/mL||Standard Deviation|Geometric Mean
639514|NCT02391038|Primary|Phase 1: Cycle 2- AUCinf: Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) for TAb||Day 1 of Cycle 2: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient TAb concentration time data to permit reliable estimation of the PK parameters where Cycle 2 Day1 PK assessment were available. Data is not reported for MLN0264 1.2 mg/kg arm because none of the participants had data evaluable for this measure.||day*mcg/mL||Standard Deviation|Geometric Mean
639515|NCT02391038|Primary|Phase 1: Cycle 1- AUCinf: Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) for TAb||Day 1 of Cycle 1: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient TAb concentration time data to permit reliable estimation of the PK parameters where Cycle 1 Day 1 PK assessment were available.||day*mcg/mL||Standard Deviation|Geometric Mean
639516|NCT02391038|Primary|Phase 1: Cycle 2- Tmax: Time to Reach the Maximum Serum Concentration (Cmax) for TAb||Day 1 of Cycle 2: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient TAb concentration time data to permit reliable estimation of the PK parameters where Cycle 2 Day 1 PK assessment were available.||day||Full Range|Median
639517|NCT02391038|Primary|Phase 1: Cycle 1- Tmax: Time to Reach the Maximum Serum Concentration (Cmax) for TAb||Day 1 of Cycle 1: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient TAb concentration time data to permit reliable estimation of the PK parameters.||day||Full Range|Median
639518|NCT02391038|Primary|Phase 1: Cycle 2- Cmax: Maximum Observed Serum Concentration for TAb||Day 1 of Cycle 2: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient TAb concentration time data to permit reliable estimation of the PK parameters where Cycle 2 Day 1 PK assessment were available.||mcg/mL||Standard Deviation|Geometric Mean
639519|NCT02391038|Primary|Phase 1: Cycle 1- Cmax: Maximum Observed Serum Concentration for Total Antibody (TAb)||Day 1 of Cycle 1: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient TAb concentration time data to permit reliable estimation of the PK parameters.||mcg/mL||Standard Deviation|Geometric Mean
639520|NCT02391038|Primary|Phase 1: Cycle 2- Ctrough: Observed Concentration Measured at the End of a Dosing Interval for MLN0264||Day 1 of Cycle 2: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MLN0264 concentration time data to permit reliable estimation of MLN0264 exposure where Cycle 2 Day 1 PK assessment were available. Data is not reported for MLN0264 1.2 mg/kg arm as none of the participants had data evaluable for this measure.||mcg/mL||Standard Deviation|Geometric Mean
639521|NCT02391038|Primary|Phase 1: Cycle 1- Ctrough: Observed Concentration Measured at the End of a Dosing Interval for MLN0264||Day 1 of Cycle 1: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MLN0264 concentration time data to permit reliable estimation of MLN0264 exposure where Cycle 1 Day 1 PK assessment were available.||mcg/mL||Standard Deviation|Geometric Mean
639522|NCT02391038|Primary|Phase 1: Cycle 2- AUCint: Area Under the Serum/Plasma Concentration-time Curve From Time 0 to End of the 21-day Dosing Interval (AUCint) for MLN0264||Day 1 of Cycle 2: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MLN0264 concentration time data to permit reliable estimation of MLN0264 exposure where Cycle 2 Day 1 PK assessment were available. Data is not reported for MLN0264 1.2 mg/kg arm as none of the participants had data evaluable for this measure.||day*mcg/mL||Standard Deviation|Geometric Mean
639523|NCT02391038|Primary|Phase 1: Cycle 1- AUCint: Area Under the Serum/Plasma Concentration-time Curve From Time 0 to End of the 21-day Dosing Interval (AUCint) for MLN0264||Day 1 of Cycle 1: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MLN0264 concentration time data to permit reliable estimation of MLN0264 exposure where Cycle 1 Day 1 PK assessment were available.||day*mcg/mL||Standard Deviation|Geometric Mean
639524|NCT02391038|Primary|Phase 1: Cycle 2- AUCinf: Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) for MLN0264||Day 1 of Cycle 2: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MLN0264 concentration time data to permit reliable estimation of MLN0264 exposure where Cycle 2 Day 1 PK assessment were available.||day*mcg/mL||Standard Deviation|Geometric Mean
639525|NCT02391038|Primary|Phase 1: Cycle 1- AUCinf: Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) for MLN0264||Day 1 of Cycle 1: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MLN0264 concentration time data to permit reliable estimation of MLN0264 exposure where Cycle 1 Day 1 PK assessment were available.||day*mcg/mL||Standard Deviation|Geometric Mean
639526|NCT02391038|Primary|Phase 1: Cycle 2- Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for MLN0264||Day 1 of Cycle 2: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MLN0264 concentration time data to permit reliable estimation of MLN0264 exposure where Cycle 2 Day 1 PK assessment were available.||day||Full Range|Median
639527|NCT02391038|Primary|Phase 1: Cycle 1- Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for MLN0264||Day 1 of Cycle 1: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MLN0264 concentration time data to permit reliable estimation of MLN0264 exposure.||day||Full Range|Median
639528|NCT02391038|Primary|Phase 1: Cycle 2- Cmax: Maximum Observed Plasma Concentration for MLN0264||Day 1 of Cycle 2: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MLN0264 concentration time data to permit reliable estimation of MLN0264 exposure where Cycle 2 Day 1 PK assessment were available.||mcg/mL||Standard Deviation|Geometric Mean
639529|NCT02391038|Primary|Phase 1: Cycle 1- Cmax: Maximum Observed Plasma Concentration for MLN0264||Day 1 of Cycle 1: predose and at multiple time points (up to 336 hours) post-dose|The Pharmacokinetic (PK) evaluable population included all participants who received greater than or equal to (>=1) dose of MLN0264 and had sufficient MLN0264 concentration time data to permit reliable estimation of MLN0264 exposure.||microgram per milliliter (mcg/mL)||Standard Deviation|Geometric Mean
639530|NCT02391038|Primary|Phase 1- Recommended Phase 2 Dose (RP2D)|RP2D is maximum tolerated dose(MTD) in study Phase1.MTD was highest dose of MLN0264 given at which <=1 of 6 participants experienced DLTduring Cycle1 of Phase1.DLT=any event related to MLN0264:Grade 4 neutropenia ANC less than<500 cells mm^3;>=Grade 3 neutropenia with fever/infection;Grade 4 thrombocytopenia(platelets <25,000/mm^3)/requires platelet transfusion(with/without hemorrhage);Grade 3/greater thrombocytopenia with clinically meaningful bleeding;Anemia requiring blood transfusion;>=Grade 3 nausea/emesis occurring despite using optimal anti-emetic prophylaxis;>=Grade 3 diarrhea despite optimal supportive care measures;any other >=Grade 3 nonhematologic toxicity except brief(<1 week)Grade 3 fatigue;Inability to start next therapy cycle>2 weeks due to delayed treatment and adequate recovery of MLN0264-related hematologic or nonhematologic toxicity;other>= Grade 2 MLN0264-related nonhematologic toxicity which requires dose reduction or discontinuation of therapy.|Phase 1: Baseline through 30 days after the last dose of study drug (Approximately up to 35 weeks)|The DLT-Evaluable population included all participants who either experienced DLT during Cycle 1 or received their scheduled Cycle 1 dose and completed all study procedures in Cycle 1 without DLT.||mg/kg|||Number
639531|NCT02391038|Primary|Phase 1- Number of Participants With Clinically Significant Change From Baseline in Vital Signs|Vital signs include body temperature (oral or tympanic measurement), sitting blood pressure (after the participant has rested for at least 5 minutes), and pulse (beats per minute [bpm]).|Phase 1: Baseline through 30 days after the last dose of study drug (Approximately up to 35 weeks)|Safety population included all participants who received any amount of study drug.||participants|||Number
639532|NCT02391038|Primary|Phase 1- Number of Participants With Markedly Abnormal Laboratory Values|The number of participants with any markedly abnormal standard safety laboratory values collected throughout study. Laboratory assessment includes serum chemistry, hematology, urine analysis and coagulation.|Phase 1: Baseline through 30 days after the last dose of study drug (Approximately up to 35 weeks)|Safety population included all participants who received any amount of study drug.||participants|||Number
639533|NCT02391038|Primary|Phase 1- Number of Participants Experiencing Dose-limiting Toxicities (DLTs)|Toxicity evaluated as per NationalCancerInstituteCommonTerminologyCriteria for AEs (NCI CTCAE),version 4.03.DLT=any event related to MLN0264:Grade 4 neutropenia(absolute neutrophil count[ANC]less than[<]500 cells/millimeter[mm]^3); >=Grade 3 neutropenia with fever/infection;Grade 4 thrombocytopenia(platelets <25,000/mm^3)/requires platelet transfusion(with/without hemorrhage);Grade 3/greater thrombocytopenia with clinically meaningful bleeding;Anemia requiring blood transfusion;>=Grade 3 nausea/emesis occurring despite using optimal anti-emetic prophylaxis;>=Grade 3 diarrhea despite optimal supportive care measures;any other >=Grade 3 nonhematologic toxicity except brief(<1 week)Grade 3 fatigue;Inability to start next therapy cycle greater than (>)2 weeks due to delayed treatment and adequate recovery of MLN0264-related hematologic or nonhematologic toxicity;other>= Grade 2 MLN0264-related nonhematologic toxicity which requires dose reduction or discontinuation of therapy.|Phase 1: Up to Cycle 1 (3 weeks)|The DLT-Evaluable population included all participants who either experienced DLT during Cycle 1 or received their scheduled Cycle 1 dose and completed all study procedures in Cycle 1 without DLT.||participants|||Number
639534|NCT02391038|Primary|Phase 1- Number of Participants Reporting One or More Serious Adverse Events (SAE)||Phase 1: Baseline through 30 days after the last dose of study drug (Approximately up to 35 weeks)|Safety population included all participants who received any amount of study drug.||participants|||Number
639535|NCT02391038|Primary|Phase 1- Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)||Phase 1: Baseline through 30 days after the last dose of study drug (approximately up to 35 weeks)|Safety population includes all participants who received any amount of study drug.||participants|||Number
639557|NCT02389881|Primary|Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post-Dose|The percentage of participants with any markedly abnormal standard safety laboratory values (chemistry and hematology) collected throughout study.|Cohorts 1-4 Day 1 to Day 40; Cohort 5 Day 1 to Day 14|Safety Set, all enrolled participants who received at least 1 dose of study drug.||percentage of participants|||Number
639536|NCT02390167|Secondary|Percent of Self-Test Alternate Site Palm Blood Glucose (BG) Results (From Subjects WITH and WITHOUT Diabetes) Within +/- 15 mg/dL (<75 mg/dL) and Within +/- 15% (>= 75 mg/dL) of Laboratory Glucose Method|Untrained subject WITH and WITHOUT diabetes self-tested Alternate Site (AST) palm blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 15 mg/dL (< 75 mg/dL YSI capillary plasma) and +/- 15% (>= 75 mg/dL YSI capillary plasma).|1 hour|366 (375-9) Blood glucose results were analyzed. Nine (9) subjects with low blood sugar did not attempt palm testing per protocol.||Percent of Results within 15mg/dL/15%|||Number
639537|NCT02390167|Secondary|Percent of Self-Test Fingerstick Blood Glucose (BG) Results (From Subjects WITH and WITHOUT Diabetes) Within +/- 15 mg/dL (<75 mg/dL) and Within +/- 15% (>= 75 mg/dL) of Laboratory Glucose Method|Untrained subject WITH and WITHOUT diabetes self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 15 mg/dL (< 75 mg/dL YSI capillary plasma) and +/- 15% (>= 75 mg/dL YSI capillary plasma).|1 hour|372 (375 - 3) Blood glucose results were analyzed. Three subjects did not obtain meter BG results after three attempts.||Percent of Results within 15mg/dL/15%|||Number
639538|NCT02390167|Secondary|Percent of Responses From Persons WITH Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding Views/Behaviors Related to Self-Monitoring Blood Glucose|Staff obtained responses from persons WITH Diabetes using short questionnaires to provide feedback on views and behaviors related to managing their diabetes. Subjects could respond 'Strongly Agree' or 'Agree' or are 'Neutral' or 'Disagree' or 'Strongly Disagree' or 'Choose Not to Answer'.|1 hour|||Percent of Subjects who responded|||Number
639539|NCT02390167|Secondary|Percent of Responses From Persons WITH and WITHOUT Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding BGMS|Staff obtained responses from persons WITH and WITHOUT Diabetes using short questionnaires to provide feedback on instructions for use and the basic operation of the BGMS. Subjects could respond 'Strongly Agree' or 'Agree' or are 'Neutral' or 'Disagree' or 'Strongly Disagree'.|1 hour|||Percent of Subjects who responded|||Number
639540|NCT02390167|Secondary|Percent of Responses From Persons WITH Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding BGMS|Staff obtained responses from persons WITH Diabetes (332) using short questionnaires to provide feedback on instructions for use and the basic operation of the BGMS. Subjects could respond 'Strongly Agree' or 'Agree' or are 'Neutral' or 'Disagree' or 'Strongly Disagree'.|1 hour|||Percent of Subjects who responded|||Number
639541|NCT02390167|Secondary|Percent of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 12.5mg/dL (<100mg/dL) and Within +/- 12.5% (>=100 mg/dL) of Laboratory Glucose Method|Untrained subjects WITH Diabetes (332) self-tested fingerstick blood using an Investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 12.5 mg/dL (<100 mg/dL YSI capillary plasma) and +/- 12.5% (>=100 mg/dL YSI capillary plasma).|1 hour|329 (332-3) Blood glucose results were analyzed. Three subjects did not obtain meter BG result after three attempts.||Percent of Results within12.5mg/dL/12.5%|||Number
639542|NCT02390167|Secondary|Percent of Subject Fingerstick Blood Glucose (BG) Results Within +/- 20% of Laboratory Glucose Method When Tested By Study Staff|Study staff tested subject (332 WITH and 43 WITHOUT diabetes) fingerstick blood using an Investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 20% of the laboratory method across the entire tested YSI glucose range.|1 hour|375 Blood glucose results were analyzed.||Percent of Results within 20%|||Number
639543|NCT02390167|Secondary|Percent of Subject Fingerstick Blood Glucose (BG) Results Within +/- 15% of Laboratory Glucose Method When Tested By Study Staff|Study staff tested subject (332 WITH and 43 WITHOUT diabetes) fingerstick blood using an Investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 15% of the laboratory method across the entire tested YSI glucose range.|1 hour|375 Blood glucose results were analyzed.||Percent of Results within 15%|||Number
639544|NCT02390167|Secondary|Percent of Self-Test Alternate Site Palm Blood Glucose (BG) Results Within +/- 20% of Laboratory Glucose Method Across the Tested Glucose Range|Untrained subjects WITH diabetes (332) and WITHOUT diabetes (43) self-tested AST palm blood using an Investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 20% of the laboratory reference method across the entire tested YSI glucose range.|1 hour|361 (375-14) Blood glucose results were analyzed. Nine (9) subjects with low blood sugar did not attempt palm testing per protocol. Five (5) subjects had low blood sugar; their palm results were not evaluable per protocol.||Percent of Results within 20%|||Number
639545|NCT02390167|Secondary|Percent of Self-Test Alternate Site Palm Blood Glucose (BG) Results Within +/- 15% of Laboratory Glucose Method Across the Tested Glucose Range|Untrained subjects WITH diabetes (332) and WITHOUT diabetes (43) self-tested AST palm blood using an Investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 15% of the laboratory reference method across the entire tested YSI glucose range.|1 hour|361 (375-14) Blood glucose results were analyzed. Nine (9) subjects with low blood sugar did not attempt palm testing per protocol. Five (5) subjects had low blood sugar; their palm results were not evaluable per protocol.||Percent of Results within 15%|||Number
639700|NCT02382133|Primary|Accuracy as Indicated by Co-oximetry Measure of Arterial Oxygen Saturation|accuracy of sensor measure was defined as sensor measurements within 3% of co-oximetry measures|24 hours|Nasal sensor unable to obtain a signal 7% of measures on enrollment, Forehead sensor unable to obtain signal 32% of measures on enrollment.||Participants|||Count of Participants
639546|NCT02390167|Secondary|Percent of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 20% of Laboratory Glucose Method Across the Tested Glucose Range|Untrained subjects WITH diabetes (332) and WITHOUT diabetes (43) self-tested Fingerstick blood using an Investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 20% of the laboratory reference method across the entire tested YSI glucose range.|1 hour|372 (375-3) Blood glucose results were analyzed. Three subjects did not contain meter BG results after three attempts.||Percent of Results within 20%|||Number
639547|NCT02390167|Secondary|Percent of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15% of Laboratory Glucose Method Across the Tested Glucose Range|Untrained subjects WITH Diabetes (332) and WITHOUT Diabetes (43) self-tested fingerstick blood using an Investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 15% of the laboratory reference method across the entire tested YSI glucose range.|1 hour|372 (375-3) Blood glucose results were analyzed. Three subjects did not obtain meter BG results after three attempts.||Percent of Results within 15%|||Number
639548|NCT02390167|Secondary|Percent of Venous Blood Glucose (BG) Results (From Subjects WITH Diabetes) Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method When Tested by Study Staff|Study staff tested venous blood of 332 subjects WITH diabetes using an Investigational Blood Glucose Monitoring System (BGMS). Venous BGMS results were compared with subject venous plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer venous plasma BG results were used to calculate the percent of BGMS results within +/- 15 mg/dL (<100 mg/dL YSI venous plasma) and +/- 15% (>=100 mg/dL YSI venous plasma).|1 hour|330 (332-2) Blood glucose results were analyzed. Two (2) subjects had unsuccessful venipuncture attempts, so no venous results were obtained for them.||Percent of Results within 15mg/dL/15%|||Number
639549|NCT02390167|Secondary|Percent of Subject Fingerstick Blood Glucose (BG) Results (From Subjects WITH Diabetes) Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method When Tested by Study Staff|Study staff tested subject (332 WITH diabetes) fingerstick blood using an Investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 15 mg/dL (<100 mg/dL YSI capillary plasma) and +/- 15% (>=100 mg/dL YSI capillary plasma).|1 hour|332 Blood glucose results from subjects with diabetes were analyzed.||Percent of Results within 15mg/dL/15%|||Number
639550|NCT02390167|Secondary|Percent of Alternate Site Palm Blood Glucose (BG) Results (From Subjects WITH Diabetes) Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method|Untrained subjects WITH Diabetes (332) self-tested Alternate Site (AST) palm blood using an Investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 15 mg/dL (<100 mg/dL YSI capillary plasma) and +/- 15% (>=100 mg/dL YSI capillary plasma).|1 hour|318 (332 with diabetes -14) Blood glucose results were analyzed. Nine (9) subjects with low blood sugar did not attempt palm testing per protocol. Five (5) subjects had low blood sugar; their palm results were not evaluable per protocol.||Percent of Results within 15mg/dL/15%|||Number
639551|NCT02390167|Primary|Percent of Self-Test Fingerstick Blood Glucose (BG) Results (From Subjects WITH Diabetes) Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method|Untrained subjects WITH Diabetes (332) self-tested fingerstick blood using an Investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 15 mg/dL (<100 mg/dL YSI capillary plasma) and +/- 15% (>=100 mg/dL YSI capillary plasma).|1 hour|329 (332 with diabetes-3) Blood glucose results were analyzed. Three subjects did not obtain meter BG result after three attempts.||Percent of Results within 15mg/dL/15%|||Number
639552|NCT02389881|Secondary|Mean AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for TAK-058|Area under the plasma concentration-time curve during a dosing interval, where tau (τ) is the length of the dosing interval.|Day 10 predose and at multiple time points (up to 24 hours) postdose|Pharmacokinetic Set, all participants who were in the safety set and had at least 1 measurable plasma concentration or amount of drug in urine.||ng*hr/mL||Standard Deviation|Mean
639553|NCT02389881|Secondary|Mean AUC24: Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Postdose for TAK-058|AUC24 is measure of area under the curve from time 0 to 24 hours postdose.|Day 1 predose and at multiple time points (up to 24 hours) postdose|Pharmacokinetic Set, all participants who were in the safety set and had at least 1 measurable plasma concentration or amount of drug in urine.||ng*hr/mL||Standard Deviation|Mean
639554|NCT02389881|Secondary|Mean AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-058|AUClast is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration.|Day 1 predose and at multiple time points (up to 72 hours) postdose|Pharmacokinetic Set, all participants who were in the safety set and had at least 1 measurable plasma concentration or amount of drug in urine.||ng*hr/mL||Standard Deviation|Mean
639555|NCT02389881|Secondary|Mean Cmax: Maximum Observed Plasma Concentration for TAK-058|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Day 1 predose and at multiple time points (up to 72 hours) postdose, and Day 10 predose and at multiple time points (up to 24 hours) postdose|Pharmacokinetic Set, all participants who were in the safety set and had at least 1 measurable plasma concentration or amount of drug in urine.||ng/mL||Standard Deviation|Mean
639556|NCT02389881|Primary|Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Signs at Least Once Post-Dose|The percentage of participants with any markedly abnormal standard vital sign values collected throughout study. Vital signs included blood pressure (after 5 minutes supine and at 1 and 3 minutes after standing), pulse and oral temperature.|Cohorts 1-4 Day 1 to Day 40; Cohort 5 Day 1 to Day 14|Safety Set, all enrolled participants who received at least 1 dose of study drug.||percentage of participants|||Number
639558|NCT02389881|Primary|Percentage of Participants Who Experienced at Least 1 Treatment-Emergent Adverse Event|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|Cohorts 1-4 Day 1 to Day 40; Cohort 5 Day 1 to Day 14|Safety Set, all enrolled participants who received at least 1 dose of study drug.||percentage of participants|||Number
639559|NCT02389452|Secondary|Change From Baseline in WOMAC C Score After Repeat Injection|WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC C (measure of physical function) calculated as a mean of 17 individual components, measured using a visual analogue scale (100 mm line marked by participants with score ranging from 0-100). Total score range is 0 to 100, where higher scores indicate higher worse function. Physical function refers to participant’s ability to move around and perform usual activities of daily living. Data are reported for those participants who received repeat injection. Here, baseline represents the day at which a participant received repeat injection (Week 26, 39 or 52).|Baseline; Weeks 1, 4 after repeat injection (missing data imputed by LOCF)|Repeat intent to treat population.||units on a scale||Standard Deviation|Mean
639560|NCT02389452|Secondary|Change From Baseline in WOMAC B Score After Repeat Injection|WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC B (measure of stiffness) calculated as a mean of 2 individual components, measured using a visual analogue scale (100 mm line marked by participants with score ranging from 0-100). Total score range is 0 to 100, where higher scores indicate higher stiffness. Stiffness is defined as a sensation of decreased ease in movement of joint. Data are reported for those participants who received repeat injection. Here, baseline represents the day at which a participant received repeat injection (Week 26, 39 or 52).|Baseline; Weeks 1, 4 after repeat injection (missing data imputed by LOCF)|Repeat intent to treat population.||units on a scale||Standard Deviation|Mean
639561|NCT02389452|Secondary|Change From Baseline in WOMAC A Score After Repeat Injection|WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC A (measure of pain) calculated as a mean of 5 individual components, measured using a visual analogue scale (100 mm line marked by participants with score ranging from 0-100). Total score range is 0 to 100, where higher scores indicate higher pain. Data are reported for those participants who received repeat injection. Here, baseline represents the day at which a participant received repeat injection (Week 26, 39 or 52).|Baseline; Weeks 1, 4 after repeat injection (missing data imputed by LOCF)|Repeat Intent to treat population included all participants who were eligible for repeat treatment and received at least one repeat dose of study medication.||units on a scale||Standard Deviation|Mean
639562|NCT02389452|Secondary|Change From Baseline in WOMAC A1 Subscore After Repeat Injection|WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC A1 (measure of pain during walking on a flat surface) was measured using a visual analogue scale (100 mm line marked by participants with total score ranging from 0-100). Lower score represents lower pain. Data are reported for those participants who received repeat injection. Here, baseline represents the day at which a participant received repeat injection (Week 26, 39 or 52).|Baseline; Weeks 1, 4 after repeat injection (missing data imputed by LOCF)|Repeat Intent to treat population included all participants who were eligible for repeat treatment and received at least one repeat dose of study medication.||units on a scale||Standard Deviation|Mean
639563|NCT02389452|Secondary|Time Between Initial and Repeat Synvisc-One Treatment|Time Between initial and repeat Synvisc-One Treatment was duration between initial and repeat injection in those participants who received repeat injection.|Baseline up to Week 52|ITT population. Number of participants analysed = participants from ITT population who received repeat injection.||weeks||Standard Deviation|Mean
639564|NCT02389452|Secondary|Number of Participants With Change in Concomitant Medication of Osteoarthritis Therapy at Week 52|Participants were asked about their perception regarding any additional Osteoarthritis medications or treatments or any changes in regimen or dosages compared to their baseline (Day 0) state. Any change in the therapy (increased therapy, decrease therapy, no change in therapy) during the study was reported.|Baseline up to Week 52|ITT population. Number of participants analysed = participants with baseline and Week 52 data.||participants|||Number
639565|NCT02389452|Secondary|12-Item Short Form Health Survey (SF-12)|SF-12 health survey is a self-reported questionnaire to measure participant’s profile of functional health and well–being. It includes following 12 questions (Q): Q1 In general, health status; Q2a Limitation of moderate activities; Q2b Limitation of climbing; Q3a Less accomplishment due to physical health; Q3b Limited in the kind of work or other activities due to physical health; Q4a Less accomplishment due to emotional problems; Q4b Did work or other activities less carefully than usual due to emotional problems; Q5 Pain interfere with normal work; Q6a Felt calm and peaceful; Q6b Had lot of energy; Q6c Felt downhearted and low; and Q7 Physical health or emotional problems interfered with social activities. Number of participants with response to each Q are reported.|Baseline, Week 26, 52|ITT population. Number of participants evaluable for baseline, Week 26 and Week 52 were 394, 394 and 388, respectively.||participants|||Number
639566|NCT02389452|Secondary|Clinician Observer Global Assessment (COGA) Score at Week 52|COGA (global self-assessment of target knee osteoarthritis condition) was measured using the 5 point Likert scale (0=very well, 1=well, 2=fair, 3=poor, 4=very poor) by the physician to rate participant’s osteoarthritis condition. Number of participants with different categories of PTGA score at Week 52 are reported.|Week 52 (missing data imputed by LOCF).|ITT population. Number of participants analyzed=participants with baseline and Week 52 data.||participants|||Number
639567|NCT02389452|Secondary|Patient Global Assessment (PTGA) Score at Week 52|PTGA (global self-assessment of target knee osteoarthritis condition) was measured using the 5 point Likert scale (0=very well, 1=well, 2=fair, 3=poor, 4=very poor) by participants to rate the osteoarthritis condition. Number of participants with different categories of PTGA score at Week 52 are reported.|Week 52 (missing data imputed by LOCF)|ITT population. Number of participants analyzed=participants with baseline and Week 52 data.||participants|||Number
640718|NCT02336438|Primary|Mixed Meal Testing: Difference Score: Insulin Level (μU/mL)|Difference score (trt-control) of insulin level at 30 minutes post meal.|30 minutes post-meal|||Difference score, trt-control (μU/mL)||Standard Deviation|Mean
639568|NCT02389452|Secondary|Change From Baseline in WOMAC C Score at Week 52|WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC C (measure of physical function) calculated as a mean of 17 individual components, measured using a visual analogue scale (100 mm line marked by participants with score ranging from 0-100). Total score range is 0 to 100, where higher scores indicate higher worse function. Physical function refers to participant’s ability to move around and perform usual activities of daily living.|Baseline, Week 52 (missing data imputed by LOCF)|ITT population. Number of participants analyzed=participants with baseline and Week 52 data.||units on a scale||Standard Deviation|Mean
639569|NCT02389452|Secondary|Change From Baseline in WOMAC B Score at Week 52|WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC B (measure of stiffness) calculated as a mean of 2 individual components, measured using a visual analogue scale (100 mm line marked by participants with score ranging from 0-100). Total score range is 0 to 100, where higher scores indicate higher stiffness. Stiffness is defined as a sensation of decreased ease in movement of joint.|Baseline, Week 52 (missing data imputed by LOCF)|ITT population. Number of participants analyzed=participants with baseline and Week 52 data.||units on a scale||Standard Deviation|Mean
639570|NCT02389452|Secondary|Change From Baseline in WOMAC A Score at Week 52|WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC A (measure of pain) calculated as a mean of 5 individual components, measured using a visual analogue scale (100 mm line marked by participants with score ranging from 0-100). Total score range is 0 to 100, where higher scores indicate higher pain.|Baseline, Week 52 (missing data imputed by LOCF)|ITT population. Number of participants analyzed=participants with baseline and Week 52 data.||units on a scale||Standard Deviation|Mean
639571|NCT02389452|Secondary|Change From Baseline in WOMAC A1 Subscore at Week 52|WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC A1 (measure of pain during walking on a flat surface) was measured using a visual analogue scale (100 mm line marked by participants with total score ranging from 0-100). Lower score represents lower pain.|Baseline, Week 52 (missing data imputed by LOCF)|ITT population. Number of participants analyzed=participants with baseline and Week 52 data.||units on a scale||Standard Deviation|Mean
639572|NCT02389452|Primary|Change From Baseline in WOMAC A1 Subscore at Week 26|WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC A1 (measure of pain during walking on a flat surface) was measured using a visual analogue scale (100 mm line marked by participants with total score ranging from 0-100). Lower score represents lower pain.|Baseline, Week 26 (missing data imputed by Last Observation Carried Forward [LOCF]).|ITT population.||units on a scale||Standard Deviation|Mean
639573|NCT02389374|Secondary|Frequency and Type of Variants of the G6PD Gene Within the Study Population||day 0 or 1||12/2019||||
639574|NCT02389374|Secondary|The Distribution of G6PD Activity Measured in U/gHb Among All Malaria Patients||day 0|||U/gHb||Inter-Quartile Range|Median
639575|NCT02389374|Secondary|Proportion of Patients Adhering to 14 Days of Primaquine Treatment in the Vivax Cohort as Measured by Pill Count||day 16|||Participants|||Count of Participants
639576|NCT02389374|Secondary|Recurrence of Parasitaemia Within 16 Days of Follow up||day 16|||Recurrences of Parsitaemia|||Number
639577|NCT02389374|Secondary|Proportion of Patients With Fever on Day 2 After Treatment||day 2|||Participants|||Count of Participants
639578|NCT02389374|Secondary|Proportion of Patients With Any Parasitemia on Day 3 After Treatment||day 3|||participants|||Number
639579|NCT02389374|Secondary|Proportion of Patients With Anaemia Less Than 8g/dl on Day 2||on day 2|||participants with Hb under 8g/dl|||Number
639580|NCT02389374|Secondary|Fractional Change in Hb Between Baseline and Day 9 and 16||day 0 and 16|||percent change Hb||95% Confidence Interval|Mean
639581|NCT02389374|Secondary|Proportion of Patients Receiving Blood Transfusion and With Severe Anaemia (Hb<7g/dl)||day 28|||participants|||Number
639582|NCT02389374|Primary|The Proportion of Adverse and Serious Adverse Events Following Unsupervised Primaquine Treatment|The proportion of adverse and serious adverse events following unsupervised primaquine treatment until day 28|during follow up (day 28)|||events|||Number
639583|NCT02389361|Secondary|Neuropathic Pain|Difference between groups in term of neuropathic pain (as measured by the DN4 score). The DN4 score is a score based on the answer to 10 items. 1 point by item. Thus DN4 Score range are between 0 and 10. A worse outcome is defined as a score > 3.|at 6 months||||||
639584|NCT02389361|Primary|Acute Pain|Difference between groups in term of analgesia (as measured by Visual Analog Scale: VAS). The VAS range are between 0 and 10. A worse outcome was defined as VAS > 4. The VAS use units on a scale.|In recovery room|||units on a scale||Standard Deviation|Median
639585|NCT02389088|Primary|Testosterone, Androstenedione and 17-OH Progesterone During Phase I and Phase II|Testosterone, Androstenedione and 17-OH Progesterone (nmol/L) measured during Phase I (without Letrozole) and during Phase II (with Letrozole) at time 24 hours during Week 0 and times 0 and 24 hours during Weeks 5 and 6 after FSH stimulation.|At time 24 hours during Week 0 and times 0 and 24 hours during Weeks 5 and 6 after FSH stimulation for both Phase I and Phase II|Phase I and Phase II - PCOS patients.||nmol/L||Standard Deviation|Mean
639586|NCT02389088|Primary|LH and FSH During Phase I and Phase II|LH and FSH (IU/L) measured during Phase I (without Letrozole) and during Phase II (with Letrozole) at time 24 hours during Week 0 and times 0 and 24 hours during Weeks 5 and 6 after FSH stimulation.|At time 24 hours during Week 0 and times 0 and 24 hours during Weeks 5 and 6 after FSH stimulation for both Phase I and Phase II|Phase I and Phase II - PCOS patients.||IU/L||Standard Deviation|Mean
639587|NCT02389088|Primary|Inhibin B During Phase I and Phase II|Inhibin B (ng/L) measured during Phase I (without Letrozole) and during Phase II (with Letrozole) at time 24 hours during Week 0 and times 0 and 24 hours during Weeks 5 and 6 after FSH stimulation.|At time 24 hours during Week 0 and times 0 and 24 hours during Weeks 5 and 6 after FSH stimulation for both Phase I and Phase II|Phase I and Phase II - PCOS patients.||ng/L||Standard Deviation|Mean
639588|NCT02389088|Primary|Estradiol During Phase I and Phase II|Estradiol (pmol/L) measured during Phase I (without Letrozole) and during Phase II (with Letrozole) at time 24 hours during Week 0 and times 0 and 24 hours during Weeks 5 and 6 after FSH stimulation.|At time 24 hours during Week 0 and times 0 and 24 hours during Weeks 5 and 6 after FSH stimulation for both Phase I and Phase II|Phase I and Phase II - PCOS patients.||pmol/L||Standard Deviation|Mean
639589|NCT02388815|Primary|Point Accuracy|"Point accuracy of Sensor based glucose values versus fingerstick blood glucose determined as % within Consensus Error Grid zone A.
The Consensus Error Grid was developed from a survey of 100 clinicians to evaluate the accuracy of glucose measurements. Glucose results from the system under test (y) are paired with those from a reference method (x) and each (x,y) point is plotted on a grid. The grid has 5 risk categories, assigned by the clinicians surveyed. Risk categories (in order of increasing severity) are: Zone A: no effect on clinical action; Zone B: altered clinical action or little or no effect on clinical outcome; Zone C: altered clinical action likely to effect clinical outcome; Zone D: altered clinical action, could have significant medical risk; Zone E: altered clinical action, could have dangerous consequences.
Result were calculated for all subjects ie total number of sensor results and fingerstick blood glucose results divided by the total number of results x 100."|14 days|One subject withdrew prior to having a sensor applied, another did not perform any blood glucose tests on the FreeStyle Libre. Neither subject could be included in the accuracy analysis, both are included in the safety analysis.||percentage of glucose results in zone A||95% Confidence Interval|Number
639590|NCT02388763|Secondary|High Contrast TCVA (VA Unit) Pre-Exposure to Reduced Humidity at Day 10|High contrast TCVA was assessed after 3 hours exposure to normal environment and prior to exposure to reduced humidity environment. Both eyes contributed to the analysis.|Day 10, each product|Intent to Treat Subjects||VA unit||Standard Deviation|Mean
639591|NCT02388763|Primary|High Contrast Time-Controlled Visual Acuity (TCVA) (VA Unit) Post-Exposure to Reduced Humidity at Day 10|High contrast TCVA was assessed after 3 hours exposure to reduced humidity environment. TCVA test was performed at 4 meters under high illumination (90%) using a Landolt ring test. For each acuity level, a series of single rings with gaps in one of four directions was presented and the percentage of correctly identified rings constituted the score. TCVA was measured in VA units and a higher TCVA value indicates an improvement in visual acuity. Both eyes contributed to the analysis.|Day 10, each product|Intent to Treat||VA unit||Standard Deviation|Mean
639592|NCT02387268|Secondary|Percentage of Participants in Whom the Cecum Was Reached|A procedure was considered complete when the cecum was reached and visualized.|During the colonoscopy procedure|||percentage of participants||95% Confidence Interval|Number
639593|NCT02387268|Primary|Safety as Measured by Number of Serious Adverse Events and Major Complications.||Max of 9 days||||||
639594|NCT02387268|Primary|Percentage Subjects With Post Procedure Cleansing Level as Measured by the Boston Bowel Preparation Scale (BBPS) Adequate Cleansing-(BBPS>1 )|"Scale ranges- Min-0, Max-3 where:
0 = Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared.
= Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool and/or opaque liquid.
= Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well.
= Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid. The wording of the scale was finalized after incorporating feedback from three colleagues experienced in colonoscopy."|During the colonoscopy procedure withdrawal phase (10 min in average)|||percentage of participants||95% Confidence Interval|Number
639595|NCT02388347|Secondary|Percentage of Participants Positive for Anti-Drug Antibodies to MEDI7836|A participant was considered ADA-positive across the study if they had a positive reading at any time point during the study.|Predose on Day 1 to 281 days Postdose|"As Treated Population included all randomized participants and treated with MEDI7836 or placebo. Here, n is number of participants analysed at given time point."||Percentage of participant|||Number
639596|NCT02388347|Secondary|Apparent Terminal-Phase Volume of Distribution (Vz/F) of MEDI7836|The apparent volume of distribution of MEDI7836 after a single dose, calculated according to the equation: Vz/F = Apparent total clearance (CL/F) / terminal phase rate constant (λz).|Predose on Day 1 and on Days 2, 3, 4, 6, 8, 10, 15, 29, 43, 57, 85, 113, 169, 225 and 281 Postdose|PK Population included all participants who received MEDI7836 had detectable postdose MEDI7836 serum concentrations.||mL||Standard Deviation|Mean
639597|NCT02388347|Secondary|Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI7836|The Tmax is defined as actual sampling time to reach maximum observed MEDI7836 concentration.|Predose on Day 1 and on Days 2, 3, 4, 6, 8, 10, 15, 29, 43, 57, 85, 113, 169, 225 and 281 Postdose|PK Population included all participants who received MEDI7836 had detectable postdose MEDI7836 serum concentrations.||day||Full Range|Median
639598|NCT02388347|Secondary|Terminal Phase Elimination Half Life (T1/2) of MEDI7836|Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the serum.|Predose on Day 1 and on Days 2, 3, 4, 6, 8, 10, 15, 29, 43, 57, 85, 113, 169, 225 and 281 Postdose|PK Population included all participants who received MEDI7836 had detectable postdose MEDI7836 serum concentrations.||day||Standard Deviation|Mean
639599|NCT02388347|Secondary|Apparent Systemic Clearance (CL/F) of MEDI7836|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body.|Predose on Day 1 and on Days 2, 3, 4, 6, 8, 10, 15, 29, 43, 57, 85, 113, 169, 225 and 281 Postdose|PK Population included all participants who received MEDI7836 had detectable postdose MEDI7836 serum concentrations.||milliliter per day (mL/day)||Standard Deviation|Mean
639600|NCT02388347|Secondary|Maximum Observed Serum Concentration (Cmax) of MEDI7836|The Cmax is the maximum observed serum concentration of study drug.|Predose on Day 1 and on Days 2, 3, 4, 6, 8, 10, 15, 29, 43, 57, 85, 113, 169, 225 and 281 Postdose|PK Population included all participants who received MEDI7836 had detectable postdose MEDI7836 serum concentrations.||microgram per milliliter (mcg/mL)||Standard Deviation|Mean
639601|NCT02388347|Secondary|Area Under the Concentration-Time Curve From Zero to Last Observation (AUC [0-t]) of MEDI7836|Area under the concentration-time curve of the MEDI7836 in serum over the time interval from 0 to the last quantifiable data point (AUC0-t).|Predose on Day 1 and on Days 2, 3, 4, 6, 8, 10, 15, 29, 43, 57, 85, 113, 169, 225 and 281 Postdose|PK Population included all participants who received MEDI7836 had detectable postdose MEDI7836 serum concentrations.||day*mcg/mL||Standard Deviation|Mean
639602|NCT02388347|Secondary|Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity]) of MEDI7836|Area under the concentration-time curve of the MEDI7836 in serum over the time interval from 0 extrapolated to infinity (AUC0-inf).|Predose on Day 1 and on Days 2, 3, 4, 6, 8, 10, 15, 29, 43, 57, 85, 113, 169, 225 and 281 Postdose|Pharmacokinetic (PK) Population included all participants who received MEDI7836 had detectable postdose MEDI7836 serum concentrations.||Day*microgram per milliliter||Standard Deviation|Mean
662322|NCT01824446|Primary|Cmax Whole Blood Total Radioactivity of Radiolabelled SSP-004184||Up to 288 hours post-dose|PAS||ng equivalents/ml||Standard Deviation|Mean
639603|NCT02388347|Primary|Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse Events|AEs observed in participants with clinically significant ECG abnormalities were assessed. ECG parameters included heart rate, RR, PR, QRS, QT and QTc intervals. Treatment-emergent adverse events between administration of investigational product and Day 281 that were absent before treatment or that worsened relative to pre-treatment state.|From Study Drug Administration to 281 Days Postdose|As Treated Population included all randomized participants and treated with MEDI7836 or placebo.||Participant|||Number
639604|NCT02388347|Primary|Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as Treatment-Emergent Adverse Events|Vital sign parameters included blood pressure, temperature, pulse rate, respiratory rate and weight. Physical examination included assessment of general appearance, weight, head, ears, eyes, nose, throat, neck, skin, cardiovascular system, respiratory system, abdominal system, and nervous system. Criteria for abnormal physical findings was based on investigator's discretion. TEAEs were present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug until Day 281 after the last dose of study drug.|From Study Drug Administration to 281 Days Postdose|As Treated Population included all randomized participants and treated with MEDI7836 or placebo.||Participant|||Number
639605|NCT02388347|Primary|Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events|An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Treatment-emergent adverse events between first dose of study drug and Day 281 after the last dose that were absent before treatment or that worsened relative to pre-treatment state. Laboratory evaluations (haematology, serum chemistry and urinalysis) of blood and urine samples were performed.|From Study Drug Administration to 281 Days Postdose|As Treated Population included all randomized participants and treated with MEDI7836 or placebo.||Participant|||Number
639606|NCT02388347|Primary|Number of Participants With Injection Site Reactions|Participants were evaluated for manifestations of injection site reactions.|From Study Drug Administration to 281 Days Postdose|As Treated Population included all randomized participants and treated with MEDI7836 or placebo.||Participant|||Number
639607|NCT02388347|Primary|Number of Participants With Treatment- Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|Any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening situation (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received MEDI7836. Treatment-emergent adverse events between administration of investigational product and Day 281 that were absent before treatment or that worsened relative to pretreatment state.|From Study Drug Administration to 281 Days Postdose|As Treated Population included all randomized participants and treated with MEDI7836 or placebo.||Participant|||Number
639608|NCT02388295|Other Pre-specified|Exploratory Efficacy: Unified Multiple System Atropy Rating Scale, Change From Baseline (Total Score, Part 1 + Part 2)|Exploratory efficacy: Unified Multiple System Atropy Rating Scale, change from baseline (total Score, Part 1 + Part 2) : Score range 0 to 104, positive value indicates worsening symptoms|Baseline to final treatment visit|Efficacy population: with baseline (Day -1) and post baseline assessment||Score change from baseline||90% Confidence Interval|Least Squares Mean
639609|NCT02388295|Secondary|Myeloperoxidase (MPO) Inhibition in Plasma (Change From Baseline), Specific Activity|Myeloperoxidase (MPO) inhibition in plasma (change from baseline), on samples collected and analyzed, specific activity (activity/protein)|Baseline (Day -1) and week 12|efficacy population, restricted to subjects with paired samples analyzed within 6 months of collection||ratio||90% Confidence Interval|Least Squares Mean
639610|NCT02388295|Primary|Striatum Brain Region: Change From Baseline in Microglia Activation Via Positron Emission Tomography(PET)|Striatum Brain region: Change from baseline in microglia activation via PET By [11C]PBR28 binding to translocator protein|Baseline (pre randomization) and Week 12|PET analysis population (Paired baseline and week 12 PET scans)||ml/cc||Standard Deviation|Mean
639611|NCT02388191|Secondary|Pain 15 Minutes After IUD Insertion Using a 10cm (100 mm) Visual Analog Scale (VAS)|"Pain 15 minutes after IUD insertion will occur 15 minutes after IUD insertion is complete using a 10cm (100 mm) visual analog scale (VAS). Patients are presented with a 100 mm line. On one end of the line, the anchor is 0 = No pain. On the opposite end of the line, the anchor is 10 = worst pain possible. Subjects are asked: Where 0 is no pain and 10 is the worst pain possible, please record your pain on the scale below. Research staff measure the distance between the 0 = No pain anchor and the mark made by the patient (in mm) to score the measure."|Fifteen minutes after IUD insertion is complete|||units on a scale||Inter-Quartile Range|Median
639612|NCT02388191|Secondary|Pain 5 Minutes After IUD Insertion Using a 10cm (100 mm) Visual Analog Scale (VAS)|"Pain 5 minutes after IUD insertion will occur five minutes after IUD insertion is complete using a 10cm (100 mm) visual analog scale (VAS). Patients are presented with a 100 mm line. On one end of the line, the anchor is 0 = No pain. On the opposite end of the line, the anchor is 10 = worst pain possible. Subjects are asked: Where 0 is no pain and 10 is the worst pain possible, please record your pain on the scale below. Research staff measure the distance between the 0 = No pain anchor and the mark made by the patient (in mm) to score the measure."|Five minutes after IUD insertion is complete|||units on a scale||Inter-Quartile Range|Median
639613|NCT02388191|Secondary|Pain With Uterine Sounding Using a 10cm (100 mm) Visual Analog Scale (VAS)|"Pain with uterine sounding will be measured immediately after uterine sounding using a 10cm (100 mm) visual analog scale (VAS). Patients are presented with a 100 mm line. On one end of the line, the anchor is 0 = No pain. On the opposite end of the line, the anchor is 10 = worst pain possible. Subjects are asked: Where 0 is no pain and 10 is the worst pain possible, please record your pain on the scale below. Research staff measure the distance between the 0 = No pain anchor and the mark made by the patient (in mm) to score the measure."|Immediately after uterine sounding|||units on a scale||Inter-Quartile Range|Median
639970|NCT02368314|Primary|Frequency of Symptomatic Nonlethal Thromboembolia of the Pulmonary Artery (PATE)||During the treatment period (14 days)|Patient who finished the study as per protocol and had contrast venography results for efficacy evaluation.||participants|||Number
639614|NCT02388191|Secondary|Pain With Tenaculum Placement Using a 10cm (100 mm) Visual Analog Scale (VAS)|"Pain with tenaculum placement will be measured immediately after tenaculum is placed on the cervix using a 10cm (100 mm) visual analog scale (VAS). Patients are presented with a 100 mm line. On one end of the line, the anchor is 0 = No pain. On the opposite end of the line, the anchor is 10 = worst pain possible. Subjects are asked: Where 0 is no pain and 10 is the worst pain possible, please record your pain on the scale below. Research staff measure the distance between the 0 = No pain anchor and the mark made by the patient (in mm) to score the measure."|Immediately after tenaculum is placed on cervix|||units on a scale||Inter-Quartile Range|Median
639615|NCT02388191|Primary|Pain at Time of IUD Insertion Using a 10 cm (100 mm) Visual Analog Scale (VAS)|"Pain at time of IUD insertion will be measured immediately upon completion of IUD insertion using a 100 mm visual analog scale (VAS). Patients are presented with a 100 mm line. On one end of the line, the anchor is 0 = No pain. On the opposite end of the line, the anchor is 10 = worst pain possible. Subjects are asked: Where 0 is no pain and 10 is the worst pain possible, please record your pain on the scale below. Research staff measure the distance between the 0 = No pain anchor and the mark made by the patient (in mm) to score the measure."|Immediately after IUD insertion is complete|||units on a scale||Inter-Quartile Range|Median
639616|NCT02388074|Primary|Number of Red Fluorescent [i.e., Cancer] Cells (RFCs) in Sputum From Healthy Participants|"The presence or absence of red fluorescent (RFCs) cancer cells was evaluated in sputum samples from healthy individuals labeled with CyPath®.
Testing for the study was performed at one study center to collect sputum samples from healthy individuals who have no known lung disease. Comparison of sputum specimens from one cohort of Participants who are healthy with two additional cohorts of Participants, including individuals at high risk for lung cancer and individuals diagnosed with lung cancer, that has already been completed."|2 months|22 participants were evaluated by a cytopathologist. Of these 22, PAP-stained slides of 3 participants were unreadable, 14 participants had provided samples that were confirmed by PAP as inadequate and only 5 slides were confirmed by PAP as adequate deep lung sputum samples. These 5 samples were evaluated for the presence of RFCs.||number of RFCs per participant||Standard Deviation|Mean
639632|NCT02387983|Primary|Steady-state Area Under the Concentration-time Curve (ssAUC0-24hr) of Posaconazole on Day 8|The ssAUC0-24hr was calculated to determine the mean plasma drug concentration in the Intensive and Sparse PK subgroup from immediately after dosing to 24 hours post-dose on Day 8. Results data are presented as the arithmetic mean (% arithmetic coefficient of variation [CV]), where CV is calculated as (100 x standard deviation/arithmetic mean).|Pre-dose and 2, 4, 6, 8, 12, and 24 hours post-dose on Day 8|The PK analysis set included all randomized and treated participants in the Intensive and Sparse PK subgroup who complied with the protocol and have documented adherence to daily dosing and PK regimens through the Day 8 steady-state evaluation and have data available.||hr*ng/mL||Standard Deviation|Mean
640719|NCT02336438|Primary|Mixed Meal Testing: Difference Score: Blood Glucose Level (mg/dL)|Difference score (trt-control) of blood glucose at 120 minutes post meal.|120 minutes post-meal|||Difference score, trt-control (mg/dL)||Standard Deviation|Mean
639625|NCT02387983|Primary|Tmax of Posaconazole on Day 1|The Tmax was calculated in order to determine the time required to reach Cmax in the Immediate and Sparse PK subgroup on Day 1.|Pre-dose and 2, 4, 6, 8, 12, and 24 hours post-dose on Day 1|The PK analysis set included all randomized and treated participants in the Intensive and Sparse PK subgroup who complied with the protocol and have documented adherence to daily dosing and PK regimens through the Day 8 steady-state evaluation with available data.||Hours||Full Range|Median
639626|NCT02387983|Primary|Cmin of Posaconazole on Day 1|The Cmin was calculated in order to determine the lowest measurable drug concentration from immediately after dosing to 24 hours post-dose in the Immediate and Sparse PK subgroup on Day 1. Results data are presented as the arithmetic mean (% arithmetic coefficient of variation [CV]), where CV is calculated as (100 x standard deviation/arithmetic mean).|Pre-dose and 2, 4, 6, 8, 12, and 24 hours post-dose on Day 1|The PK analysis set included all randomized and treated participants in the Intensive and Sparse PK subgroup who complied with the protocol and have documented adherence to daily dosing and PK regimens through the Day 8 steady-state evaluation with available data.||ng/mL||Standard Deviation|Mean
639627|NCT02387983|Primary|Cmax of Posaconazole on Day 1|The Cmax was calculated to determine the maximum plasma drug concentration up to 24 hours post-dose in the Immediate and Sparse PK subgroup on Day 1. Results data are presented as the arithmetic mean (% arithmetic coefficient of variation [CV]), where CV is calculated as (100 x standard deviation/arithmetic mean).|Pre-dose and 2, 4, 6, 8, 12, and 24 hours post-dose on Day 1|The PK analysis set included all randomized and treated participants in the Immediate and Sparse PK subgroup who complied with the protocol and have documented adherence to daily dosing and PK regimens through the Day 8 steady-state evaluation with available data.||ng/mL||Standard Deviation|Mean
639628|NCT02387983|Primary|AUC0-24hr of Posaconazole on Day 1|The AUC0-24hr was calculated to determine the mean plasma drug concentration from immediately after dosing to 24 hours post-dose in the Immediate and Sparse PK subgroup on Day 1. Results data are presented as the arithmetic mean (% arithmetic coefficient of variation [CV]), where CV is calculated as (100 x standard deviation/arithmetic mean).|Pre-dose and 2, 4, 6, 8, 12, and 24 hours post-dose on Day 1|The PK analysis set included all randomized and treated participants in the Intensive and Sparse PK subgroup who complied with the protocol and have documented adherence to daily dosing and PK regimens through the Day 8 steady-state evaluation with available data.||hr*ng/mL||Standard Deviation|Mean
639629|NCT02387983|Primary|Time to Steady-state Maximum Concentration (ssTmax) of Posaconazole on Day 8|The ssTmax was calculated in order to determine the amount of time required to reach ssCmax in the Intensive and Sparse PK subgroup on Day 8.|Pre-dose and 2, 4, 6, 8, 12, and 24 hours post-dose on Day 8|The PK analysis set included all randomized and treated participants in the Intensive and Sparse PK subgroup who complied with the protocol and have documented adherence to daily dosing and PK regimens through the Day 8 steady-state evaluation with available data.||hr||Full Range|Median
639630|NCT02387983|Primary|Steady-state Minimum Concentration (ssCmin) of Posaconazole on Day 8|The ssCmin was calculated in order to determine the lowest measurable drug concentration in the Intensive and Sparse PK subgroup up to 24 hours post-dose on Day 8. Results data are presented as the arithmetic mean (% arithmetic coefficient of variation [CV]), where CV is calculated as (100 x standard deviation/arithmetic mean).|Pre-dose and 2, 4, 6, 8, 12, and 24 hours post-dose on Day 8|The PK analysis set included all randomized and treated participants in the Intensive and Sparse subgroup who complied with the protocol and have documented adherence to daily dosing and PK regimens through the Day 8 steady-state evaluation with available data.||ng/mL||Standard Deviation|Mean
639631|NCT02387983|Primary|Steady-state Maximum Concentration (ssCmax) of Posaconazole on Day 8|The ssCmax was calculated in order to determine the maximum post-dose plasma drug concentration in the Intensive and Sparse PK subgroup on Day 8. Results data are presented as the arithmetic mean (% arithmetic coefficient of variation [CV]), where CV is calculated as (100 x standard deviation/arithmetic mean).|Pre-dose and 2, 4, 6, 8, 12, and 24 hours post-dose on Day 8|The PK analysis set included all randomized and treated participants in the Intensive and Sparse PK subgroup who complied with the protocol and have documented adherence to daily dosing and PK regimens through the Day 8 steady-state evaluation with available data.||ng/mL||Standard Deviation|Mean
639649|NCT02387554|Secondary|CL/F|CL/F(Apparent clearance)|0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr||||||
639650|NCT02387554|Secondary|T1/2|T1/2(Terminal elimination half-life),|0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr||||||
639651|NCT02387554|Secondary|Tmax|Tmax(Time to maximum concentration)|0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr||||||
639633|NCT02387983|Primary|Steady-state Average Concentration (ssCavg) of Posaconazole on Day 8|The ssCavg was calculated in order to determine the percentage of participants achieving the pharmacokinetic (PK) target of ssCavg >500 ng/mL on Day 8 when plasma drug levels had reached steady state.|Pre-dose and 2, 4, 6, 8, 12, and 24 hours post-dose on Day 8|The PK analysis set included all randomized and treated participants who complied with the protocol and have documented adherence to daily dosing and PK regimens through the Day 8 steady-state evaluation and have data available.||Percentage of Participants|||Number
639634|NCT02387801|Secondary|Time to at Least a 2 Point Improvement on the PatGA Score|The PatGA is a patient-administered single-item scale on which participants are asked to rank by selecting a number on a 0 to 5 NRS the severity of their psoriasis “today” from 0 (Clear) = no psoriasis to 5 (Severe) = the worst their psoriasis has ever been.|Baseline though Week 12|All randomized participants.||Days||90% Confidence Interval|Median
639635|NCT02387801|Secondary|Mean Change From Baseline on the Psoriasis Area and Severity Index (PASI)|The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 75 were defined as having an improvement of at least 75% in PASI scores compared to baseline. LS means are from analysis of MMRM and the model includes treatment group, baseline value, visit and treatment-by-visit interaction.|Baseline, Week 12|All randomized participants.||units on a scale||Standard Error|Least Squares Mean
639636|NCT02387801|Secondary|Mean Change From Baseline in Percent Body Surface Area (%BSA)|The BSA is the percentage involvement of psoriasis on each participant's body surface on a continuous scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participant’s hand (including the palm, fingers, and thumb). The total BSA affected was the summation of individual regions affected. LS means are from analysis of MMRM and the model includes treatment group, baseline value, visit and treatment-by-visit interaction|Baseline, Week 12|All randomized participants.||percentage of body surface area||Standard Error|Least Squares Mean
639637|NCT02387801|Secondary|Mean Change From Baseline on the Dermatology Life Quality Index (DLQI)|"The DLQI is a simple, patient-administered, 10-question, validated, quality-of-life questionnaire that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include “Not at all,” “A little,” A lot, and Very much, with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of “Not relevant” which is scored as “0”. For all questions, if unanswered the question is scored as “0”. Totals range from 0 to 30 (less to more impairment). LS means are from analysis of MMRM and model includes treatment group, baseline value and timepoint."|Baseline, Week 12|All randomized participants.||units on a scale||Standard Error|Least Squares Mean
639638|NCT02387801|Secondary|Mean Change From Baseline on Itch Numeric Rating Scale (NRS) Score|The Itch NRS is a patient-administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing “no itch” and 10 representing “worst itch imaginable.” Overall severity of a participant's itching from psoriasis (Ps) is indicated by circling the number that best describes the worst level of itching in the past 24 hours. Least Square Means (LS means) are from analysis of mixed-effects model for repeated measures (MMRM) and model includes treatment group, baseline value and timepoint.|Baseline, Week 12|All randomized participants.||units on a scale||Standard Error|Least Squares Mean
639639|NCT02387801|Primary|Time to at Least a 1 Point Improvement on the Patient's Global Assessment of Disease Severity (PatGA) Score|The PatGA is a patient-administered single-item scale on which participants are asked to rank by selecting a number on a 0 to 5 Numeric Rating Score (NRS) the severity of their psoriasis “today” from 0 (Clear) = no psoriasis to 5 (Severe) = the worst their psoriasis has ever been.|Baseline through Week 12|All randomized participants.||Days||90% Confidence Interval|Median
639640|NCT02387710|Secondary|Arousal Threshold (Esophageal Pressure Swing)|The arousal threshold was quantified as the mean of all the nadir negative esophageal pressure swings immediately preceding an arousal at the end of an obstructive apnea or hypopnea during both placebo and tiagabine nights.|1 night|||cmH2O||Inter-Quartile Range|Median
639641|NCT02387710|Secondary|Slow Wave Sleep (% Total Sleep Time)|Fraction of sleep spent in stage N3|1 night|||% total sleep time||Inter-Quartile Range|Median
639642|NCT02387710|Primary|Apnea Hypopnea Index (AHI)|Number of apneas + hypopneas per hour of sleep. Hypopnea criteria: reduction in 30% of baseline flow plus 3% desaturation or arousal.|1 night|||events/hour||Inter-Quartile Range|Median
639643|NCT02387580|Primary|Piperaquine AUC(0–168 h)|PQP Area under the plasma concentration versus time curve|Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 168 hours and Day36 post-dose|The PK population was to include all valid profiles from subjects dosed with IMP. 45 subjects were included in the PK population. 3 subjects vomited approximately 1 to 2 h after dosing and were excluded.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
639644|NCT02387580|Primary|Piperaquine Cmax|Piperaquine Maximum observed concentration|Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 168 hours and Day36 post-dose|The PK population was to include all valid profiles from subjects dosed with IMP. 45 subjects were included in the PK population. 3 subjects vomited approximately 1 to 2 h after dosing and were excluded.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
639645|NCT02387580|Primary|OZ439 AUC(0–168 h)|OZ439 Area under the plasma concentration (AUC) versus time curve|pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 168 hours post-dose|The PK population was to include all valid profiles from subjects dosed with IMP. 45 subjects were included in the PK population. 3 subjects vomited approximately 1 to 2 h after dosing and were excluded.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
639646|NCT02387580|Primary|OZ439 Cmax|OZ439 Maximum observed concentration|Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 168 hours post-dose|The PK population was to include all valid profiles from subjects dosed with IMP. 45 subjects were included in the PK population. 3 subjects vomited approximately 1 to 2 h after dosing and were excluded.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
639647|NCT02387554|Other Pre-specified|Number of Paticipants With Adverse Events||3 months||||||
639648|NCT02387554|Secondary|Vz/F|Vz/F(Apparent volume of distribution)|0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr||||||
639656|NCT02384538|Secondary|Patient Global Assessment of Hand Osteoarthritis (OA) Status by NRS-11: Change From Baseline to Each Visit|"Participants were asked how much they were affected by hand OA by responding to the question Considering all the ways your hand OA affects you, how have you been during the last 48 hours? using an 11-point scale (NRS-11). Scores range from 0 to 10 points, with higher scores indicating greater effect of hand OA on the participant. A decrease in the NRS-11 score represents an improvement the effect of hand OA on the participant."|Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26|All participants in the mITT population.||units on a scale||95% Confidence Interval|Least Squares Mean
639657|NCT02384538|Secondary|Participant Assessment of Index Hand Pain Intensity Using Numeric Rating Scale (NRS-11): Change From Baseline to Each Visit|Participants rated the pain intensity of each hand during the previous 48 hours using an 11-point scale (NRS-11). The change from baseline to each visit in NRS-11 in the index hand (the hand with the most disease) are presented. Scores range from 0 to 10 points, with higher scores indicating greater pain intensity. A decrease in the NRS-11 score represents a decrease in pain intensity.|Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26|All participants in the mITT population.||units on a scale||95% Confidence Interval|Least Squares Mean
639658|NCT02384538|Secondary|Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Total Score: Change From Baseline to Each Visit|The AUSCAN NR3.1 is a self-report measure composed of a battery of 15 questions assessing the three dimensions of pain (5 questions), joint stiffness (1 question) and physical function (9 questions) using an 11-box Numerical Rating Scale (NRS-11) from 0 (low) to 10 (high). The total score ranges from 0 to 150; lower scores indicate better status. A decrease in the total score represents improvement in status. LOCF: Missing responses were imputed by calculation based on the last nonmissing postbaseline component values.|Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26|All participants in the mITT population.||units on a scale||95% Confidence Interval|Least Squares Mean
639659|NCT02384538|Secondary|Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Stiffness Subdomain Score: Change From Baseline to Each Visit|The AUSCAN NR3.1 is a self-report measure composed of a battery of 15 questions assessing the three dimensions of pain (5 questions), joint stiffness (1 question) and physical function (9 questions) using an 11-box Numerical Rating Scale (NRS-11) from 0 (low) to 10 (high). The stiffness subdomain score ranges from 0 to 10; lower scores indicate better status. A decrease in the stiffness subdomain score represents improvement in status. LOCF: Missing responses were imputed by calculation based on the last nonmissing postbaseline component values.|Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26|All participants in the mITT population.||units on a scale||95% Confidence Interval|Least Squares Mean
639660|NCT02384538|Secondary|Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Physical Function Subdomain Score: Change From Baseline to Each Visit|The AUSCAN NR3.1 is a self-report measure composed of a battery of 15 questions assessing the three dimensions of pain (5 questions), joint stiffness (1 question) and physical function (9 questions) using an 11-box Numerical Rating Scale (NRS-11) from 0 (low) to 10 (high). The physical function subdomain score ranges from 0 to 90; lower scores indicate better status. A decrease in the physical function subdomain score represents improvement in status. LOCF: Missing responses were imputed by calculation based on the last nonmissing postbaseline component values.|Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26|All participants in the mITT population.||units on a scale||95% Confidence Interval|Least Squares Mean
639661|NCT02384538|Secondary|Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Pain Subdomain Score: Change From Baseline to Each Visit|The AUSCAN NR3.1 is a self-report measure composed of a battery of 15 questions assessing the three dimensions of pain (5 questions), joint stiffness (1 question) and physical function (9 questions) using an 11-box Numerical Rating Scale (NRS-11) from 0 (low) to 10 (high). The pain subdomain score ranges from 0 to 50; lower scores indicate better status. A decrease in the pain subdomain score represents improvement in status. LOCF: Missing responses were imputed by calculation based on the last nonmissing postbaseline component values.|Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26|All participants in the mITT population.||units on a scale||95% Confidence Interval|Least Squares Mean
639662|NCT02384538|Primary|Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Pain Subdomain Score: Change From Baseline to Week 16|The AUSCAN NR3.1 is a self-report measure composed of a battery of 15 questions assessing the three dimensions of pain (5 questions), joint stiffness (1 question) and physical function (9 questions) using an 11-box Numerical Rating Scale (NRS-11) from 0 (low) to 10 (high). The pain subdomain score ranges from 0 to 50; lower scores indicate better status. A decrease in the pain subdomain score represents improvement in status. Last Observation Carried Forward (LOCF): Missing responses were imputed by calculation based on the last nonmissing postbaseline component values.|Week 0 (Baseline), Week 16|mITT population: all randomized participants who received at least 1 dose of study drug.||units on a scale||95% Confidence Interval|Least Squares Mean
639663|NCT02384070|Secondary|Sub-clinical Ischemic Events Measured by Troponin Levels Post-procedure||48 hours post procedure|||participants|||Number
639664|NCT02384070|Secondary|TIMI (Thrombolysis in Myocardial Infarction) Major and Minor Bleeding Scores|"Major: Intracranial bleeding, Clinically overt signs of hemorrhage associated with a drop in hemoglobin of ≥5 g/dL or a ≥15% absolute decrease in haematocrit or Fatal bleeding.
Minor: Clinically overt (including imaging), resulting in hemoglobin drop of 3 to <5 g/dL or ≥10% decrease in haematocrit. No observed blood loss: ≥4 g/dL decrease in the haemoglobin concentration or ≥12% decrease in haematocrit Any overt sign of hemorrhage that meets one of the following criteria and does not meet criteria for a major or minor bleeding event, as defined above Requiring intervention"|Hospital Stay and after 30 days post PCI|||Patients|||Number
639665|NCT02384070|Primary|Thrombotic Complications||Hospital Stay and after 30 days post PCI|||Number of Patients|||Number
639666|NCT02383862|Secondary|Percentage of Participants With Medications Ordered for SPADE Symptoms at Baseline Clinic Visit|Electronic medical records were reviewed to determine the number of medications ordered for SPADE symptoms at the baseline clinic visit. The percentage of participants in each group with 0, 1, 2, or 3≤ medications ordered for SPADE symptoms at baseline was calculated.|baseline|Participants whose electronic medical record of the baseline clinic visit was available for review||percentage of participants|||Number
639701|NCT02381678|Primary|The Performance Evaluation of Perimount Heart Valve(Type:6900P and 2900) by Echocardiography|This is a one-arm study. All enrolled 225 subjects are required to be back Gungdong General Hospital to do an Echocardiography|7-15 years after heart valve replacement surgery (during 2001-2007)|||Percentage of all subjects|||Number
639667|NCT02383862|Secondary|Percentage of Participants With Tests Ordered (Other Than Radiologic and Laboratory Tests) for SPADE Symptoms at Baseline Clinic Visit|Electronic medical records were reviewed to determine the number of tests ordered, other than radiologic or laboratory tests (e.g., sleep study), for SPADE symptoms at the baseline clinic visit. The percentage of participants in each group with 0 or 1≤ tests ordered for SPADE symptoms at baseline was calculated.|baseline|Participants whose electronic medical record of the baseline clinic visit was available for review||percentage of participants|||Number
639668|NCT02383862|Secondary|Percentage of Participants With Radiologic (RAD) Tests Ordered for SPADE Symptoms at Baseline Clinic Visit|Electronic medical records were reviewed to determine the number of radiologic (RAD) tests ordered for SPADE symptoms at the baseline clinic visit. The percentage of participants in each group with 0 or 1≤ RAD tests ordered for SPADE symptoms at baseline was calculated.|baseline|Participants whose electronic medical record of the baseline clinic visit was available for review||percentage of participants|||Number
639669|NCT02383862|Secondary|Percentage of Participants With Laboratory Tests Ordered for SPADE Symptoms at Baseline Clinic Visit|Electronic medical records were reviewed to determine the number of laboratory tests ordered for SPADE symptoms at the baseline clinic visit. The percentage of participants in each group with 0 or 1≤ lab tests ordered for SPADE symptoms at baseline was calculated.|baseline|Participants whose electronic medical record of the baseline clinic visit was available for review||percentage of participants|||Number
639670|NCT02383862|Secondary|Fatigue at 3-month Follow up, as Measured by the SF-36 Vitality Scale|For this secondary outcome, data were collected from the group as a whole without regard to randomization. Thus, data is analyzed for the group as a whole rather than separately for each arm. At 3-month follow up, fatigue was assessed using the 4-item SF-36 (Short Form-36 Healthy Survey) vitality scale. The SF-36 vitality scale measures fatigue and energy over the past week. Possible scores range from 0 to 100, with lower scores reflecting greater fatigue.|3 month follow up|Participants who completed the SF-36 vitality scale at 3 month follow up||units on a scale||Standard Deviation|Mean
639671|NCT02383862|Secondary|Depression at 3-month Follow up, as Measured by the Patient Health Questionnaire (PHQ-2)|For this secondary outcome, data were collected from the group as a whole without regard to randomization. Thus, data is analyzed for the group as a whole rather than separately for each arm. At 3-month follow up, depression was assessed using the 2-item Patient Health Questionnaire (PHQ-2). The PHQ-2 measures the frequency of depressive symptoms over the last 2 weeks. Possible scores range from 0 to 6, with higher scores reflecting more severe depression.|3 month follow up|Participants who completed the PHQ-2 at 3 month follow up||units on a scale||Standard Deviation|Mean
639672|NCT02383862|Secondary|Anxiety at 3 Month Follow up, as Measured by the Generalized Anxiety Disorder Scale (GAD-2)|For this secondary outcome, data were collected from the group as a whole without regard to randomization. Thus, data is analyzed for the group as a whole rather than separately for each arm. At 3-month follow up, anxiety was assessed using the 2-item Generalized Anxiety Disorder scale (GAD-2). GAD-2 measures the frequency of anxiety symptoms over the past 2 weeks. Possible scores range from 0 to 6, with higher scores reflecting more severe anxiety.|3 month follow up|Participants who completed the GAD-2 at 3 month follow up||units on a scale||Standard Deviation|Mean
639673|NCT02383862|Secondary|Pain at 3 Month Follow up, as Measured by PEG|For this secondary outcome, data were collected from the group as a whole without regard to randomization. Thus, data is analyzed for the group as a whole rather than separately for each arm. At 3-month follow up, pain was assessed using the 3-item PEG (Pain intensity, Enjoyment of life, and General activity). PEG measures pain intensity and interference in the past week. Possible scores range from 0 to 10, with higher scores reflecting more intense pain and interference.|3 month follow up|Participants who completed the PEG at 3 month follow up.||units on a scale||Standard Deviation|Mean
639674|NCT02383862|Secondary|Sleep at 3-month Follow up, as Measured by the Pittsburgh Insomnia Rating Scale (PIRS-2)|For this secondary outcome, data were collected from the group as a whole without regard to randomization. Thus, data is analyzed for the group as a whole rather than separately for each arm. At 3-month follow up, sleep was assessed using the 2-item Pittsburgh Insomnia Rating Scale (PIRS-2). PIRS-2 measures quality and satisfaction with sleep over the past week. Possible scores range from 0 to 6, with higher scores reflecting poorer sleep.|3-month follow-up|Participants who completed the PIRS-2 at 3 month follow up||units on a scale||Standard Deviation|Mean
639675|NCT02383862|Secondary|Treatment Satisfaction at 3-Month Follow-up|At 3-month follow-up, treatment satisfaction was assessed. This 1-item measure assesses patients' satisfaction with the care of their symptoms overall on a 5-point Likert scale ranging from excellent to poor. Higher scores indicate poorer satisfaction.|3 month follow-up|Participants who responded to the treatment satisfaction question at 3 month follow up||Participants|||Count of Participants
639676|NCT02383862|Secondary|Change From Baseline in PROMIS Fatigue T-score at 3-Month Follow up|The 4-item PROMIS subscale for fatigue was administered to participants at baseline and at 3 month follow up. The fatigue subscale measures the extent to which patients experience problems with fatigue over the past 7 days using a 5-point Likert scale. Higher scores reflect greater fatigue. To assess the effects of feedback on fatigue, group differences in the change in PROMIS fatigue T-scores from baseline to 3-month follow up (baseline PROMIS fatigue T-score - 3 month PROMIS fatigue T-score) were calculated. Positive change scores are indicative of improvement in fatigue.|baseline and 3 month follow up|Multiple imputation was used to determine follow-up scores for nonrespondents.||T-score||Standard Error|Mean
639677|NCT02383862|Secondary|Change From Baseline in PROMIS Depression T-score at 3-Month Follow up|The 4-item PROMIS subscale for depression was administered to participants at baseline and at 3 month follow up. The depression subscale measures the extent to which patients experience depressive symptoms over the past 7 days using a 5-point Likert scale. Higher scores reflect greater depression. To assess the effects of feedback on depression, group differences in the change in PROMIS depression T-scores from baseline to 3-month follow up (baseline PROMIS depression T-score - 3 month PROMIS depression T-score) were calculated. Positive change scores are indicative of improvement in depression.|baseline and 3 month follow up|Multiple imputation was used to determine follow-up scores for nonrespondents.||T-score||Standard Error|Mean
639702|NCT02381418|Secondary|Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®.||up to 3 weeks post vaccination|||participants|||Number
640783|NCT02332902|Primary|3D Photographic Measurement of Surface Volume|Photographs of selected lesions to measure surface volume.|6 months|||mm^3||95% Confidence Interval|Mean
639678|NCT02383862|Secondary|Change From Baseline in PROMIS Anxiety T-score at 3-Month Follow up|The 4-item PROMIS subscale for anxiety was administered to participants at baseline and at 3 month follow up. The anxiety subscale measures the extent to which patients experience anxiety symptoms over the past 7 days using a 5-point Likert scale. Higher scores reflect greater anxiety. To assess the effects of feedback on anxiety, group differences in the change in PROMIS anxiety T-scores from baseline to 3-month follow up (baseline PROMIS anxiety T-score - 3 month PROMIS anxiety T-score) were calculated. Positive change scores are indicative of improvement in anxiety.|baseline and 3 month follow up|Multiple imputation was used to determine follow-up scores for nonrespondents.||T-score||Standard Error|Mean
639679|NCT02383862|Secondary|Change From Baseline in PROMIS Pain T-score at 3-Month Follow up|The 4-item PROMIS subscale for pain was administered to participants at baseline and at 3 month follow up. The pain subscale measures the extent to which patients experience problems with pain over the past 7 days using a 5-point Likert scale. Higher scores reflect greater pain. To assess the effects of feedback on pain, group differences in the change in PROMIS pain T-scores from baseline to 3-month follow up (baseline PROMIS pain T-score - 3 month PROMIS pain T-score) were calculated. Positive change scores are indicative of improvement in pain.|baseline and 3 month follow up|Multiple imputation was used to determine follow-up scores for nonrespondents.||T-score||Standard Error|Mean
639680|NCT02383862|Secondary|Change From Baseline in PROMIS Sleep T-score at 3-Month Follow up|The 4-item PROMIS subscale for sleep was administered to participants at baseline and at 3 month follow up. The sleep subscale measures the extent to which patients experience problems with sleep over the past 7 days using a 5-point Likert scale. Higher scores reflect more severe sleep problems. To assess the effects of feedback on sleep, group differences in the change in PROMIS sleep T-scores from baseline to 3 month follow up (baseline PROMIS sleep T-score - 3 month PROMIS sleep T-score) were calculated. Positive change scores are indicative of improvement in sleep.|baseline and 3 month follow up|Multiple imputation was used to determine follow-up scores for nonrespondents.||T-score||Standard Error|Mean
639681|NCT02383862|Primary|Change From Baseline in PROMIS Composite T-Score at 3-Month Follow-up|The 20-item PROMIS questionnaire (composed of 4-item scales for each of the 5 SPADE symptoms) was administered to participants at baseline and at 3 month follow up. PROMIS assesses the extent to which patients experience problems with SPADE symptoms over the past 7 days using a 5-point Likert scale. Higher scores reflect greater symptom severity. To assess the effects of feedback on SPADE symptom improvement, group differences in the change in PROMIS composite T-scores from baseline to 3 month follow up (baseline PROMIS T-score - 3 month PROMIS T-score) were calculated. Positive change scores are indicative of symptom improvement.|baseline and 3 month follow up|Multiple imputation was used to determine follow-up scores for nonrespondents.||T-score||Standard Error|Mean
639682|NCT02383719|Primary|Clinician Assessment of Use With a Questionnaire|"With the questionnaire we desired to discern the clinicians perception of use of the experimental oro-nasal mask. The questionnaire featured the ease of installation, the ease of use, and the perceived comfort of the patient. Each of the scores were on a scale from 1-5 and each were recorded to be used for individual assessment. Thus each patient has multiple assessment scores individually reported as outcomes.
The clinicians were asked on a scale of 1-5 please rate their agreement with the statements The mask was easy to use. 1 strongly disagree, 2 somewhat disagree, 3 neutral, 4 somewhat agree, 5 strongly agree Your perception of patient comfort was acceptable. 1 strongly disagree, 2 somewhat disagree, 3 neutral, 4 somewhat agree, 5 strongly agree"|During non-invasive ventilation with the oro-nasal mask|||units on a scale||Inter-Quartile Range|Median
639683|NCT02383420|Secondary|Pair Preference Rating Scale|During the Reader Study the radiologists completed a paired preference rating using the following scale: -3, Image displayed on left is strongly preferred; -2, Image displayed on left is moderately preferred; -1, Image displayed on left is slightly preferred; 0, No preference between the images; 1, Image displayed on right is slightly preferred; 2, Image displayed on right is moderately preferred; 3, Image displayed on right is strongly preferred. Both the predicate and investigational images were randomly assigned to appear on the right or left monitors. A spreadsheet was used for managing the data. Prior to analysis, raw ratings were converted so that those in favor of the investigational device were made positive, and ratings in favor of the predicate device were made negative.|9 weeks after last x-ray capture|cadavers and live human subjects||units on a scale|Participants|Standard Error|Mean
639684|NCT02383420|Primary|Radlex Scale for Diagnostic Capability Ratings|1-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.|9 weeks after last x-ray capture|A total of 177 image pairs were included for the reader study. Of the 177 pairs, 160 were cadaver image pairs. A total of seventeen (17) adult live human subject pairs were included in the reader study.||units on a scale|Participants|Standard Error|Mean
639685|NCT02382913|Primary|Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points.|"Geometric Mean Ratios of anti-PT, anti-FHA and anti-PRN antibody were calculated to measure the changes in immunogenicity concentrations within subjects from all V113_01 time points to V113_01E1 day 1.
Note: The mean and confidence intervals of Licensed Tdap for the same antigen can be different (from aP to Tdap table) since two different statistical model were fitted within each antigen: one with aP and Licensed Tdap groups and one with Tdap and Licensed Tdap groups."|Day 1, Day 8, Day 30, Day 180, Day 365 of V113_01 and Day 1 of V113_01E1|Analysis were done on per protocol set. Note: Number of participants analyzed for Day 1 of V113_01E1/ Day 180 of V113_01 FHA and PRN was 33, 28, 28, 32 respectively.||Ratios||95% Confidence Interval|Geometric Mean
639703|NCT02381418|Primary|the Serum Antihemagglutinin Antibody Titers and the Derived Parameters Defined in the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance on Harmonization of Requirements for Influenza Vaccines for Influenza Vaccines.|Mean fold increase in HI antibody titer 3 weeks After Vaccination in non-elderly adults and elderly adults.|3 weeks post vaccination|Two subjects were excluded from the efficacy sample due to major protocol violations with a potential effect on immunogenicity outcome.||fold change||95% Confidence Interval|Mean
639686|NCT02382913|Primary|Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points.|"Geometric Mean Ratios of anti-PT, anti-FHA and anti-PRN antibody were calculated to measure the changes in immunogenicity concentrations within subjects from all V113_01 time points to V113_01E1 day 1.
Note: The mean and confidence intervals of Licensed Tdap for the same antigen can be different (from aP to Tdap table) since two different statistical model were fitted within each antigen: one with aP and Licensed Tdap groups and one with Tdap and Licensed Tdap groups."|Day 1, Day 8, Day 30, Day 180, Day 365 of V113_01 and Day 1 of V113_01E1|Analysis were done on per protocol set||Ratios||95% Confidence Interval|Geometric Mean
639687|NCT02382913|Primary|Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points.|"Geometric Mean Ratios of anti-PT, anti-FHA and anti-PRN antibody were calculated to measure the changes in immunogenicity concentrations within subjects from all V113_01 time points to V113_01E1 day 1.
Note: The mean and confidence intervals of Licensed Tdap for the same antigen can be different (from aP to Tdap table) since two different statistical model were fitted within each antigen: one with aP and Licensed Tdap groups and one with Tdap and Licensed Tdap groups."|Day 1, Day 8, Day 30, Day 180, Day 365 of V113_01 and Day 1 of V113_01E1|Analysis were done on per protocol set. Note: Number of participants analyzed for Day 1 of V113_01E1/ Day 180 of V113_01 PT, FHA and PRN was 27, 32, 31, 32 respectively.||Ratios||95% Confidence Interval|Geometric Mean
639688|NCT02382913|Primary|Geometric Mean Concentrations (GMCs) of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens at Day 1.|"The antibody response against the pertussis antigen components (PT, FHA and PRN) in serum at day 1 as measured by Multiplex ELISA and reported as Geometric Mean Concentrations (GMCs) in T5D4aP1, T5D4aP2 and T5D4aP4 Groups versus the response to the commercially available Tdap comparator.
Note: The mean and confidence intervals of Licensed Tdap for the same antigen can be different (from aP to Tdap table) since two different statistical model were fitted within each antigen: one with aP and Licensed Tdap groups and one with Tdap and Licensed Tdap groups."|Day 1|Analysis were done on per protocol set.||IU/mL||95% Confidence Interval|Geometric Mean
639689|NCT02382913|Primary|Geometric Mean Concentrations (GMCs) of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens at Day 1.|"The antibody response against the pertussis antigen components (PT, FHA and PRN) in serum at day 1 as measured by Multiplex ELISA and reported as Geometric Mean Concentrations (GMCs) in T5D2aP1, T5D2aP2 and T5D2aP4 Groups versus the response to the commercially available Tdap comparator.
Note: The mean and confidence intervals of Licensed Tdap for the same antigen can be different (from aP to Tdap table) since two different statistical model were fitted within each antigen: one with aP and Licensed Tdap groups and one with Tdap and Licensed Tdap groups."|Day 1|Analysis were done on per protocol set.||IU/mL||95% Confidence Interval|Geometric Mean
639690|NCT02382913|Primary|Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens at Day 1.|"The antibody response against the pertussis antigen components (PT, FHA and PRN) at day 1 as measured by Multiplex ELISA and reported as Geometric Mean Concentrations (GMCs) in aP1, aP2, aP4 Groups versus the response to the commercially available Tdap comparator.
Note: The mean and confidence intervals of Licensed Tdap for the same antigen can be different (from aP to Tdap table) since two different statistical model were fitted within each antigen: one with aP and Licensed Tdap groups and one with Tdap and Licensed Tdap groups."|Day 1|"Analysis were done on per protocol set (PPS) i.e., All subjects in the all enrolled set who provided immunogenicity data at V113_01E1 visit 1 and:
correctly received the vaccine in the V113_01 parent study
had no major protocol deviations leading to exclusion or were not excluded due to other reasons as defined prior to analysis"||IU/mL||95% Confidence Interval|Geometric Mean
639691|NCT02382640|Primary|Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiogram (ECG)||Day 1 up to 30 days after last dose of drug (Day 31 for each of the 4 periods)|The safety set was defined as all participants who were enrolled and received at least 1 dose of study drug.||participants|||Number
639692|NCT02382640|Primary|Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Evaluation||Day 1 up to 30 days after last dose of drug (Day 31 for each of the 4 periods)|The safety set was defined as all participants who were enrolled and received at least 1 dose of study drug.||participants|||Number
639693|NCT02382640|Primary|Number of Participants With Clinically Significant Change From Baseline in Physical Examination Findings||Day 1 up to 30 days after last dose of drug (Day 31 for each of the 4 periods)|The safety set was defined as all participants who were enrolled and received at least 1 dose of study drug.||participants|||Number
639694|NCT02382640|Primary|Number of Participants With Clinically Significant Change From Baseline in Vital Signs||Day 1 up to 30 days after last dose of drug (Day 31 for each of the 4 periods)|The safety set was defined as all participants who were enrolled and received at least 1 dose of study drug.||participants|||Number
639695|NCT02382640|Primary|Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)||Day 1 up to 30 days after last dose of drug (Day 31 for each of the 4 periods)|The safety set was defined as all participants who were enrolled and received at least 1 dose of study drug.||participants|||Number
639696|NCT02382640|Primary|AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Febuxostat||Days 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose|The pharmacokinetic set consisted of all participants who received study drug and had at least 1 measurable plasma concentration.||ng*hr/mL||Standard Deviation|Mean
639697|NCT02382640|Primary|AUC(0-tau): Area Under the Plasma Concentration-time Curve During the Dosing Interval for Febuxostat||Days 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose|The pharmacokinetic set consisted of all participants who received study drug and had at least 1 measurable plasma concentration.||nanogram*hour per milliliter (ng*hr/mL)||Standard Deviation|Mean
639698|NCT02382640|Primary|Cmax: Maximum Observed Plasma Concentration for Febuxostat||Days 1 at multiple timepoints (up to 48 hours) post-dose|The pharmacokinetic set consisted of all participants who received study drug and had at least 1 measurable plasma concentration.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
639699|NCT02382133|Secondary|Device Related Pressure Ulcer|"assessment for development of pressure ulcer at forehead sensor, OxiMaxTM, Nellcor,Covidien and nasal alar sensor, Alar One-SenseTM, Xhale Assurance"|5 days|incidence of any pressure injury||participants|||Number
648259|NCT02107014|Primary|Change in Eotaxin From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].|||pg/mL||95% Confidence Interval|Median
639704|NCT02381418|Primary|the Serum Antihemagglutinin Antibody Titers and the Derived Parameters Defined in the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance on Harmonization of Requirements for Influenza Vaccines for Influenza Vaccines.|Seroprotection and Seroconversion Rate for A/H1N1, A/H3N2, and B Strains 3 weeks After Vaccination in non-elderly adults and elderly adults.|3 weeks post vaccination|Two subjects were excluded from the efficacy sample due to major protocol violations with a potential effect on immunogenicity outcome.||percentage of subjects||95% Confidence Interval|Number
639705|NCT02381288|Secondary|Terminal Elimination Half-life (T1/2) for TAK-448F|T1/2 is the time required for half of the drug to be eliminated from the plasma.|Once-daily Dosing Days 1 and 42, Twice-weekly Dosing Days 1 and 39, Once-weekly Dosing Days 1 and 36, predose and at multiple time intervals (up to 8 hours) post-dose.|Due to early termination of the study pharmacokinetic data was not collected and reported.|||||
639706|NCT02381288|Secondary|AUCt: Area Under the Plasma Concentration-Time Curve for TAK-448F|Area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration.|Once-daily Dosing Days 1 and 42, Twice-weekly Dosing Days 1 and 39, Once-weekly Dosing Days 1 and 36, predose and at multiple time intervals (up to 8 hours) post-dose.|Due to early termination of the study pharmacokinetic data was not collected and reported.|||||
639707|NCT02381288|Secondary|Cmax: Maximum Observed Plasma Concentration for the Free Form of TAK-448 (TAK-448F)|Cmax is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Once-daily Dosing Days 1 and 42, Twice-weekly Dosing Days 1 and 39, Once-weekly Dosing Days 1 and 36, predose and at multiple time intervals (up to 8 hours) post-dose.|Due to early termination of the study pharmacokinetic data was not collected and reported.|||||
639708|NCT02381288|Secondary|Serum Testosterone Cmax: Maximum Observed Plasma Concentration|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. Assessments were done Day 1 and Day 42 for once daily regimen, on Day 36 for once weekly regimen and on Day 39 for twice-weekly regimen (Day 42/36/39).|Day 1 (first dose) and Day 42 for once-daily regimen, Day 39 for twice-weekly regimen, or Day 36 for once-weekly regimen (last dose)|PD analysis set included all participants who received at least 1 dose of study drug or placebo and who have at least 1 valid PD measure.||ng/dL||Standard Deviation|Mean
639709|NCT02381288|Primary|Trough Serum Concentration (Ctrough) of ST|Trough serum concentration of total and free ST, defined as lowest Baseline concentration.|Once-daily regimen Day 42; Twice-weekly regimen Day 39; Once-weekly regimen Day 36|PD analysis set included all participants who received at least 1 dose of study drug or placebo and who had at least 1 valid PD measure. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.||ng/dL||Standard Deviation|Mean
639710|NCT02381288|Primary|Percent Change From Baseline in Average Serum Concentration (Cav) of Total ST After 6 Weeks of Dosing|Cav is the average serum concentration of the dosing interval, calculated as area under the effect curve (AUEC) divided by the duration of the dosing interval.|Once-daily regimen Day 42; Twice-weekly regimen Day 39; Once-weekly regimen Day 36|Pharmacodynamic (PD) analysis set included all participants who received at least 1 dose of study drug or placebo and who had at least 1 valid PD measure.||percent change||Standard Deviation|Mean
639711|NCT02380742|Secondary|VAS Score at the Time of Pessary Insertion Adjusting for Baseline Pain|Practitioner's perception of patient's pain score at time of pessary insertion adjusting for baseline pain. Scale is from 0 to 10 centimeters (0=no pain and 10=worst pain)|Insertion of Pessary|After baseline and removal study activities were recorded, one of the patients in the placebo group was withdrawn by the investigator due to vaginal erosion.||Centimeters||Standard Error|Least Squares Mean
639712|NCT02380742|Secondary|VAS Score at the Time of Pessary Removal Adjusting for Baseline Pain and Patient Age|Self-reported pain intensity at time of pessary removal after controlling for patient age and baseline pain score. Scale is from 0 to 10 centimeters (0=no pain and 10=worst pain)|Removal of Pessary|||Centimeters||Standard Error|Least Squares Mean
639713|NCT02380742|Secondary|VAS Score at the Time of Pessary Removal Adjusting for Pessary Type and Investigator Training|Self-reported pain intensity at time of pessary removal after controlling for pessary type and investigator training level. Scale is from 0 to 10 centimeters (0=no pain and 10=worst pain)|Removal of Pessary|||Centimeters||Standard Error|Least Squares Mean
639714|NCT02380742|Primary|VAS Score at the Time of Pessary Removal Adjusting for Baseline Pain|Self-reported pain intensity at time of pessary removal controlling for baseline pain. Scale is from 0 to 10 (0=no pain and 10=worst pain)|Removal of Pessary|||Centimeters||Standard Error|Least Squares Mean
639715|NCT02380287|Other Pre-specified|Frequency of Binding Antibodies to BCD-85 Formation||day 57||||||
639716|NCT02380287|Other Pre-specified|Frequency of Early Discontinuation Due to AE||57 days||||||
639717|NCT02380287|Other Pre-specified|Frequency of Grade 3-4 AEs||57 days||||||
639718|NCT02380287|Other Pre-specified|Frequency of Local Reactions||57 days||||||
639719|NCT02380287|Other Pre-specified|Total Frequency of AE/SAE||57 days||||||
639720|NCT02380287|Other Pre-specified|Mean Pain Score by VAS Assessment During Injection of BCD-085||day 1||||||
639721|NCT02380287|Other Pre-specified|Clearance of BCD-085 After Single Subcutaneous Injection||57 days||||||
639722|NCT02380287|Other Pre-specified|Constant of Elimination of BCD-085 After Single Subcutaneous Injection||57 days||||||
639723|NCT02380287|Other Pre-specified|Half-life of BCD-085 After Single Subcutaneous Injection||57 days||||||
639724|NCT02380287|Other Pre-specified|Time of Maximum Concentration of BCD-085 After Single Subcutaneous Injection||57 days||||||
639725|NCT02380287|Secondary|Maximum Concentration of BCD-085 After Single Subcutaneous Injection||57 days||||||
639726|NCT02380287|Primary|Area Under the Plasma Concentration of BCD-085-time Curve From Zero (0) Hours to 1320 Hours After the Single Subcutaneous Injection of BCD-085||57 days|||(ng/ml)*hour||Inter-Quartile Range|Median
639727|NCT02380261|Primary|Number of Participants With Ocular Clinical Signs and Discomfort Sensations|Participants were assessed by an ophthalmologist. Ocular clinical signs included palpebral edema, conjunctival edema, orbicular secretion, keratoconus, blepharitis, meibomitis, pterygium, hyperemia, chemosis, keratitis, secretion and lacrimation. Both eyes contributed to the analysis.|Day 21|This analysis population includes all enrolled participants.||participants|||Number
639728|NCT02380261|Primary|Number of Participants With a Contact-dermatitis Adverse Reaction|Participants were assessed by a dermatologist. Contact-dermatitis adverse reaction was characterized by the presence of one or more of the following symptoms or signs: strong itching sensation, erythema, edema, desquamation, papules or vesicles. Both eyes contributed to the analysis.|Day 21|This analysis population includes all enrolled participants.||participants|||Number
639729|NCT02380248|Primary|Change From Baseline in Corneal Staining at All Study Time Points|Corneal staining was assessed by the Investigator through slit-lamp examination and reported on a scale of 0-3, where 0=normal (no staining) and 3=severe (numerous coalescent macropunctate areas and/or patches), for the 5 quadrants of each eye. The scores at each visit were summed by eye for each subject. The overall corneal staining score for the subject at each visit was then computed as the average of the sum from both eyes. Thus, the overall scores ranged between 0-15 with higher scores reflecting more damage to the corneal surface.|Baseline (Day 0), Day 45, Day 90|Full Analysis Set. Number analyzed includes number of subjects with non-missing response in specified category.||units on a scale||Standard Error|Mean
639730|NCT02379637|Secondary|Safety of Daily Dose of NAC (Number of Patients With Adverse Advents)|Number of patients with adverse advents|7 Days|||participants|||Number
639731|NCT02379637|Primary|Cough Count (Number of Coughs Will be Measured by a 24-hour Ambulatory Cough Monitoring System for the First 72 Hours)|Number of coughs will be measured by a 24-hour ambulatory cough monitoring system for the first 72 hours|72 hours|Full Analysis set||log-transformed total cough count||Standard Deviation|Mean
639732|NCT02378961|Secondary|Percentage of Participants With Virologic Failure|"On-treatment virologic failure:
Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)
Virologic relapse:
Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 24|Full Analysis Set||percentage of participants|||Number
639733|NCT02378961|Secondary|HCV RNA Change From Baseline||Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
639734|NCT02378961|Secondary|Percentage of Participants With HCV RNA < LLOQ on Treatment||Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)|Participants in the Full Analysis Set with available data were analyzed||percentage of participants||95% Confidence Interval|Number
639735|NCT02378961|Secondary|Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study treatment, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set||percentage of participants||95% Confidence Interval|Number
639736|NCT02378961|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 12 Weeks|Safety Analysis Set||percentage of participants|||Number
639737|NCT02378961|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study treatment.|Posttreatment Week 12|Full Analysis Set (FAS): participants who received at least 1 dose of study drug||percentage of participants||95% Confidence Interval|Number
639738|NCT02378506|Primary|Percentage of Participants With Positive Etanercept Anti-Drug Antibody Status: Throughout Study Treatment|Participants who developed anti-drug antibodies after treatment with Etanercept were evaluated. Percentage of participants with positive Etanercept anti-drug antibodies were summarized.|Baseline up to Week 24|Analysis set included all participants who had taken at least 1 dose of study medication and had at least 1 Etanercept anti-drug antibody evaluation.||percentage of participants||95% Confidence Interval|Number
639739|NCT02378506|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 4, 12 and 24|HAQ-DI assesses the degree of difficulty a participant has experienced during the past week in 8 domains of daily living activities: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each item scored on 4-point scale from 0 to 3: 0= no difficulty; 1= some difficulty; 2= much difficulty; 3= unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0 (least difficulty) and 3 (extreme difficulty), where higher scores indicate more difficulty while performing daily living activities.|Baseline, Week 4, 12, 24|mITT population included all participants who had taken at least 1 dose of study medication. Here, “n” signifies number of participants who were evaluable for specified time points.||units on a scale||Standard Deviation|Mean
639740|NCT02378506|Secondary|Change From Baseline in Disease Activity Scale Based on 28 Joint Count C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Week 4, 12 and 24|DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (CRP) was calculated from the number of swollen joints and tender joints using the 28 joints count, C-Reactive protein (milligram per liter [mg/L]) and participant's general health visual analog scale assessment (scores ranging 0 mm [very well] to 100 mm [extremely bad], higher scores indicate worse health condition). Total DAS28-4 (CRP) score range: 0 (none) to 10 (extreme disease activity), higher scores indicate more disease activity. DAS28-4 (CRP) less than (<) 2.6= remission, <3.2= low disease activity, greater than or equal to (>=) 3.2 to 5.1= moderate disease activity and >5.1= high disease activity.|Baseline, Week 4, 12, 24|mITT population included all participants who had taken at least 1 dose of study medication. Here, “n” signifies number of participants who were evaluable for specified time points.||units on a scale||Standard Deviation|Mean
639748|NCT02378506|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.|Baseline (Day 1) up to Week 28 (Follow-up)|Safety population included all participants who had taken at least 1 dose of study medication.||participants|||Number
639741|NCT02378506|Secondary|Change From Baseline in Disease Activity Scale Based on 28 Joint Count Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Week 4, 12 and 24|DAS28: measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated from number of swollen joints (SJC) and tender joints (TJC ) using the 28 joints count, erythrocyte sedimentation rate (millimeter per hour [mm/hour]) and participant's general health visual analog scale assessment (scores: 0 mm [very well] to 100 mm [extremely bad], higher scores indicate worse health condition). Total DAS28-4 (ESR) score: 0 (none) to 10 (extreme disease activity), higher scores indicate more disease activity. DAS28-4 (ESR) less than (<) 2.6= remission, <3.2= low disease activity, greater than or equal to (>=) 3.2 to 5.1= moderate disease activity and >5.1= high disease activity.|Baseline, Week 4, 12, 24|mITT population included all participants who had taken at least 1 dose of study medication. Here, “n” signifies number of participants who were evaluable for specified time points.||units on a scale||Standard Deviation|Mean
639742|NCT02378506|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response|ACR70 responder: participants with 70% improvement in tender and swollen 28-joint counts and 70% improvement in at least 3 of the 5 measures: participant global assessment of arthritis (PtGA), physician global assessment of arthritis (PGA), participant pain visual analogue scale (Pain-VAS), health assessment questionnaire-disability index (HAQ-DI) and C-reactive protein. PtGA: participant assessed overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. PGA: physician judged participant’s overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. Pain-VAS: participant assessed arthritis pain by 100 millimeter (mm) VAS, score: 0 mm (no pain) to 100 mm (extreme pain), higher score=more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score=more disability. Percentage of participants with ACR70 response were reported.|Week 4, 12, 24|mITT population included all participants who had taken at least 1 dose of study medication. Here, “n” signifies number of participants who were evaluable for specified time points.||percentage of participants||95% Confidence Interval|Number
639743|NCT02378506|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response|ACR50 responder: participants with 50% improvement in tender and swollen 28-joint counts and 50% improvement in at least 3 of the 5 measures: participant global assessment of arthritis (PtGA), physician global assessment of arthritis (PGA), participant pain visual analogue scale (Pain-VAS), health assessment questionnaire-disability index (HAQ-DI) and C-reactive protein. PtGA: participant assessed overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. PGA: physician judged participant’s overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. Pain-VAS: participant assessed arthritis pain by 100 millimeter (mm) VAS, score: 0 mm (no pain) to 100 mm (extreme pain), higher score=more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score=more disability. Percentage of participants with ACR50 response were reported.|Week 4, 12, 24|mITT population included all participants who had taken at least 1 dose of study medication. Here, “n” signifies number of participants who were evaluable for specified time points.||percentage of participants||95% Confidence Interval|Number
639744|NCT02378506|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response|ACR20 responder: participants with 20 percent (%) improvement in tender and swollen 28-joint counts and 20% improvement in at least 3 of the 5 measures: participant global assessment of arthritis (PtGA), physician global assessment of arthritis (PGA), participant pain visual analogue scale (Pain-VAS), health assessment questionnaire-disability index (HAQ-DI) and C-reactive protein. PtGA: participant assessed overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. PGA: physician judged participant’s overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. Pain-VAS: participant assessed arthritis pain by 100 millimeter (mm) VAS, score: 0 mm (no pain) to 100 mm (extreme pain), higher score=more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score=more disability. Percentage of participants with ACR20 response were reported.|Week 4, 12, 24|Modified intent-to-treat (mITT) population included all participants who had taken at least 1 dose of study medication. Here, “n” signifies number of participants who were evaluable for specified time points.||percentage of participants||95% Confidence Interval|Number
639745|NCT02378506|Secondary|Number of Participants With Grade 3 and 4 Clinical Laboratory Abnormalities|Laboratory abnormalities(national cancer institute toxicity criteria version 4.0),Grade 3:neutrophil (greater than or equal to[>=]0.5,less than[<]1.0 10^9/L),lymphocyte (<0.5 10^9/L),hemoglobin (Hb) (<80,>=65 gram per liter [g/L]),platelet(<50.0,>=25.0 10^9/L),white blood count(WBC) (<2.0, >=1.0 10^9/L);alkaline phosphatase (AP),aspartate aminotransferase(AST),alanine aminotransferase(ALT) (greater than[>]5.0*upper range [UR], <=20.0*UR unit per liter[U/L]);bilirubin(>1.5*UR, less than or equal to[<=]3.0*UR micromole per liter[mcmol/L]);creatinine(>3.0*UR, <=6.0*UR mcmol/L);albumin (<20.0 g/L),urea(>3.0*UR, <=4.0*UR g/L);potassium (K)-high,low (>6.0,<=7.0or<3.0,>=2.5 mcmol/L); sodium(Na)-high,low(>155, <=160 or <130, >=120 mcmol/L)and Grade 4: neutrophil(<0.5 10^9/L),Hb (<65 g/L);platelet (<25.0 10^9/L); WBC(<1.0 10^9/L);AP,AST,ALT(>20.0*UR U/L);bilirubin(>3.0*UR mcmol/L);creatinine (>6.0*UR mcmol/L);urea (>4.0*UR g/L);K-high,low (>7.0or<2.5 mcmol/L);Na-high, low (>160or<120 mcmol/L).|Baseline (Day 1) up to Week 28 (Follow-up)|Safety population included all participants who had taken at least 1 dose of study medication.||participants|||Number
639746|NCT02378506|Secondary|Number of Participants With Injection Site Reactions|Injection site reactions included injection site erythema, swelling, pain and warmth.|Baseline (Day 1) up to Week 28 (Follow-up)|Safety population included all participants who had taken at least 1 dose of study medication.||participants|||Number
639747|NCT02378506|Secondary|Number of Participants With Investigator-Identified Serious Infections|Infection was considered as serious by investigator for any of the following outcomes: death; life-threatening; required initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity or congenital anomaly/birth defect.|Baseline (Day 1) up to Week 28 (Follow-up)|Safety population included all participants who had taken at least 1 dose of study medication.||participants|||Number
639762|NCT02374398|Secondary|Cost Analysis|Charges per case.|day of surgery preoperative time to postoperative day 3 or postoperative day 2 if day 3 data are not recorded for the 4 groups|||Dollars||Standard Deviation|Mean
641941|NCT02288273|Secondary|Change in 24-hour Mean Weighted Glucose Between Day 1 of Week 10 (Day 64/65) and Day 6 of Week 10 (Day 69/70) Within Each EQW-treated Patient||Day 64/65|||mg/dL||Standard Error|Least Squares Mean
639749|NCT02378506|Secondary|Percentage of Participants With Positive Etanercept Neutralizing Anti-Drug Antibody Status: Throughout Study Treatment|Percentage of participants with positive Etanercept neutralizing anti-drug antibodies were summarized.|Baseline (Day 1) up to Week 24|Analysis set included all participants who had taken at least 1 dose of study medication and had at least 1 Etanercept anti-drug antibody evaluation.||percentage of participants||95% Confidence Interval|Number
639750|NCT02378506|Primary|Percentage of Participants With Positive Etanercept Anti-Drug Antibody Status at Week 24|Participants who developed anti-drug antibodies after treatment with Etanercept were evaluated. Percentage of participants with positive Etanercept anti-drug antibodies were summarized.|Week 24|"Analysis set included all participants who had taken at least 1 dose of study medication and had at least 1 Etanercept anti-drug antibody evaluation. Here, N signifies number of participants evaluable for this outcome measure."||percentage of participants||95% Confidence Interval|Number
639751|NCT02378506|Primary|Percentage of Participants With Positive Etanercept Anti-Drug Antibody (ADA) Status at Week 12|Participants who developed anti-drug antibodies after treatment with Etanercept were evaluated. Percentage of participants with positive Etanercept anti-drug antibodies were summarized.|Week 12|"Analysis set included all participants who had taken at least 1 dose of study medication and had at least 1 Etanercept anti-drug antibody evaluation. Here, Number of Participants Analyzed (N) signifies number of participants evaluable for this outcome measure."||percentage of participants||95% Confidence Interval|Number
639752|NCT02376998|Primary|Number of Participants With Major Adverse Events|Evaluation of mortality, renal failure, cerebrovascular accident.|from hospital discharge to 1 month after the procedure|No serious adverse events recorded||number of serious adverse events|||Number
639753|NCT02376530|Primary|Nutritional Quality of Food Purchases|The Overall Nutrient Quality Index (ONQI) was used to assess nutritional quality of foods purchased. The ONQI is a 1 - 100 scale in which higher numbers indicate higher nutritional quality. Each food is given a score based on a ratio with positive health nutrients in the numerator and detrimental health nutrients in the denominator, based on a proprietary algorithm created by NuVal. The average ONQI score for all the groceries purchases was used as the outcome measure, of ONQI scores on a scale.|Participants were followed for one shopping session, an average of 2.5 hours|Data was analyzed for 781 participants. Two participants did not understand the study, 2 participants had incorrect price manipulations during their session, 1 participant was ill during the session, 1 participant had her young daughter in the room during the experiment and 1 participant did not have a household to shop for.||Average NUVAL Score||Standard Deviation|Least Squares Mean
639754|NCT02375724|Secondary|Change From Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 8|The LCQ is a self-administered questionnaire that assesses cough related quality of life The LCQ comprises 19 items and 3 domains (physical, psychological and social) The total score ranges from 3 to 21 and each domain scores range from 1 to 7; a higher score indicates a better quality of life|Week 8|Intent to treat (ITT) population defined as all randomized patients who took at least one dose of investigational medicinal product LCQ data were available for 126/135 patients receiving aclidinium and 128/134 receiving placebo||Score||Standard Error|Least Squares Mean
639755|NCT02375724|Secondary|Change From Baseline in Overall E-RS Cough and Sputum Domain Score Over the 8 Week Study Period|The scale range of the 'cough and sputum' domain of the E-RS was 0-11, with higher scores indicating more severe symptoms|Baseline to Week 8|Intent to treat (ITT) population defined as all randomized patients who took at least one dose of investigational medicinal product E-RS data were available for 131/135 patients receiving aclidinium and 133/134 receiving placebo||Score||Standard Error|Least Squares Mean
639756|NCT02375724|Primary|Change From Baseline in Overall Exacerbations of Chronic Pulmonary Disease Tool-Respiratory Symptoms (E-RS) Total Score Over the 8 Week Study Period|The EXACT-Respiratory Symptoms (E-RS) questionnaire was completed every evening The E-RS scale is an instrument comprising a subset of EXACT items to test the effect of treatment on the severity of respiratory symptoms in stable COPD Eleven of the 14-items of the EXACT questionnaire provides information about COPD symptoms: The E-RS Total Score is an aggregate of three domains: chest symptoms (derived sum of 3 items), cough and sputum (derived sum of 3 items) and RS-breathlessness (derived sum of 4 items); Individual scores were rated from 0 to 4 The E-RS Total score is based on a logit scoring system with conversion to a 0 (lowest score) to 100 scale (highest score) with higher scores indicating more severe symptoms|Baseline to Week 8|Intent to treat (ITT) population defined as all randomized patients who took at least one dose of investigational medicinal product E-RS data were available for 131/135 patients receiving aclidinium and 133/134 receiving placebo||Score||Standard Error|Least Squares Mean
639757|NCT02375373|Primary|Changes in Number of 16S RNA Sequences on Days 31, Day 62, and Day 93.|Compare the gut microbiota composition of individual subjects before and after the implementation of a controlled and observed diet of chickpeas and legume products.|Change from Day 31, Day 62, and Day 93|Due to the rate of withdrawal from this study only one participant completed and this data was used for the outcome measures.||sequences||97.5% Confidence Interval|Mean
639758|NCT02375347|Primary|Changes in Diversity of Gut Microbiota 16S rRNA Gene Sequences With Regard to Time.|"Compare the gut microbiota composition and overall diversity of individual subjects before and after the implementation of a controlled and observed diet of chickpeas and legume products, using 16S ribosomal RNA (rRNA) sequencing of fecal samples.
The use of Operational Taxonomic Units (OTUs) are used to classify clusters of similar bacterial groups. OTUs are species or group of species often used when only DNA sequence data is available.
This measure is the average amount of OTUs found for each time point."|Change in Baseline (Day 1, Day 7-9, and Day 14)|||Avg. Operational Taxonomic Units||Standard Error|Mean
639761|NCT02374398|Secondary|Adverse Events|Complications: deep venous thrombosis(DVT) or arterial thrombosis, pulmonary embolism(PE), myocardial infarction (MI), cerebrovascular accident (CVA)|day of surgery preoperative time to postoperative day 3 or postoperative day 2 if day 3 data are not recorded for the 4 groups|||participants|||Number
639763|NCT02374398|Secondary|Post Operative Blood Loss|"The estimated blood loss was determined with the Gross formula [23]. According to a review article published in 2013, Gross’s formula though developed in 1983 is still widely used as reported. The formula which is relatively easy to use is described below:
Patient blood volume (PBV) = K (1) x height (m) 3 + K (2) x weight (kg) + K (3) Where K (1) = 0.3669 (male), 0.3561(female); K (2) = 0.03219 (male), 0.03308 (female); And K (3) = 0.6041(male), 0.1833 (female) Estimated blood loss = PBV [Hematocritinitial – Hematocritfinal ] / Hematocritmean Where mean hematocrit is the sum of initial and final hematocrit divided by two."|day of surgery preoperative time to postoperative day 3 or postoperative day 2 if day 3 data are not recorded for the 4 groups|||ml||Standard Deviation|Mean
639764|NCT02374398|Primary|The Change in Hematocrit (Ht) From the Day of Surgery|"Control group- iv placebo normal saline plus regular electrocautery.
iv TXA plus regular electrocautery.
iv placebo plus Aquamantys system and regular electrocautery.
iv TXA and Aquamantys system and regular electrocautery"|day of surgery preoperative time to postoperative day 3 or postoperative day 2 if day 3 data are not recorded for the 4 groups|||Volume % of RBC in blood||Standard Deviation|Mean
639765|NCT02374398|Primary|The Change in Hemoglobin (Hb) From the Day of Surgery|"Control group- iv placebo normal saline plus regular electrocautery.
iv TXA plus regular electrocautery.
iv placebo plus Aquamantys system and regular electrocautery.
iv TXA and Aquamantys system and regular electrocautery"|day of surgery preoperative time to postoperative day 3 or postoperative day 2 if day 3 data are not recorded for the 4 groups|||g/dl||Standard Deviation|Mean
639766|NCT02374346|Secondary|Factors Associated With Postoperative Headache|Demographic, anaesthetic and surgical factors associated with postoperative headache|6 months|||participants|||Number
639767|NCT02374346|Primary|Frequency of Postoperative Headache in Elective Surgery Patients|The observed overall frequency of postoperative headache was 28.3% (N= 126) in the total sample.|6 months|"Frequency of postoperative headache in total sample (n=446), Post-op Headache, no History of Headache (n=229), Post-op Headache, History of Headache (n=217), where n= number of participants analyzed"||participants|||Number
639768|NCT02374164|Primary|AUCinf: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for Febuxostat XR 40 mg (Regimen B) and Febuxostate XR 80 mg (Regimen C) in Fasted States|AUCinf is a measure of total plasma exposure to the drug from time zero extrapolated to infinity. Participant blood samples were collected pre-dose and following a single oral dose.|Day 1 pre-dose and at multiple timepoints (up to 48 hours) post dose|Participants from the PK population, all participants who received study drug and had at least 1 measurable plasma concentration, who received a single dose of study drug in Regimen B and C.||ng*hr/mL||Standard Deviation|Mean
639769|NCT02374164|Primary|AUCinf: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for Febuxostat XR 80 mg in Fed (Regimen A) and Fasted (Regimen C) States|AUCinf is a measure of total plasma exposure to the drug from time zero extrapolated to infinity. Participant blood samples were collected pre-dose and following a single oral dose.|Day 1 pre-dose and at multiple timepoints (up to 48 hours) post dose|Participants from the PK population, all participants who received study drug and had at least 1 measurable plasma concentration, who received a single dose of study drug in Regimen A and C.||ng*hr/mL||Standard Deviation|Mean
639770|NCT02374164|Primary|AUCt: Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration for Febuxostat XR 40 mg (Regimen B) and Febuxostat XR 80 mg (Regimen C) in Fasted States|AUCt is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUCt) Participant blood samples were collected pre-dose and following a single oral dose.|Day 1 pre-dose and at multiple timepoints (up to 48 hours) post dose|Participants from the PK population, all participants who received study drug and had at least 1 measurable plasma concentration, who received a single dose of study drug in Regimen B and C.||ng*hr/mL||Standard Deviation|Mean
639771|NCT02374164|Primary|AUCt: Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration for Febuxostat XR 80 mg in Fed (Regimen A) and Fasted (Regimen C) States|AUCt is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration. Participant blood samples were collected pre-dose and following a single oral dose.|Day 1 pre-dose and at multiple timepoints (up to 48 hours) post dose|Participants from the PK population, all participants who received study drug and had at least 1 measurable plasma concentration, who received a single dose of study drug in Regimen A and C.||ng*hr/mL||Standard Deviation|Mean
639772|NCT02374164|Primary|Cmax: Maximum Observed Plasma Concentration for Febuxostat XR 40 mg (Regimen B) and Febuxostat XR 80 mg (Regimen C) in Fasted States|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. Participant blood samples were collected pre-dose and following a single oral dose.|Day 1 pre-dose and at multiple time points (up to 48 hours) post dose|Participants from the PK population, all participants who received study drug and had at least 1 measurable plasma concentration who received a single dose of study drug in Regimen B and C.||ng/mL||Standard Deviation|Mean
639773|NCT02374164|Primary|Cmax: Maximum Observed Plasma Concentration for Febuxostat XR 80 mg in Fed (Regimen A) and Fasted (Regimen C) States|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. Participant blood samples were collected pre-dose and following a single oral dose.|Day 1 pre-dose and at multiple timepoints (up to 48 hours) post dose|Participants from the Pharmacokinetic population (PK), all participants who received study drug and had at least 1 measurable plasma concentration, who received a single dose of study drug in Regimen A and C.||ng/mL||Standard Deviation|Mean
639787|NCT02372097|Primary|AUC(0-168): Area Under the Plasma Concentration-Time Curve From Time 0 to 168 Hours Postdose for Unchanged SYR-472 (SYR-472Z)||Day 1: pre dose (within 3 hours prior to dosing), and at multiple time points (up to 168 hours) post dose in each period|The PK analysis set included all participants who received study drug, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for PK.||nanogram hour per milliliter(ng*hr/mL)||Standard Deviation|Geometric Mean
639788|NCT02372071|Primary|BiliCare TcB Result Compared to TSB Result||30 minutes within taking the blood draw for TSB (either before or after the blood draw)|||mg/dL||Standard Deviation|Mean
639789|NCT02372058|Primary|BiliCare TcB Result Compared to TSB Result||30 minutes within taking the blood draw for TSB (either before or after the blood draw)|||mg/dL||Standard Deviation|Mean
639774|NCT02372344|Primary|The Effect of Food Timing (Fasting, Before Meal, and After Meal) on PK (AUC0-72) of AZD0585 in Healthy Male Japanese.|To investigate the effect of food timing on PK (area under the plasma concentration-time curve from time zero to 72 hours [AUC0-72]) of single dose of 4 g AZD0585 in healthy male Japanese by assessing plasma concentrations of total EPA and total DHA, and PK parameters over time under the three proposed conditions (fasting, before meal, and after meal). Analyses of the outcome measures presented are for baseline-adjusted data for total EPA and DHA since the presence of endogenous levels of these fatty acids would likely contribute to intra-subject variability and affect the analyses and interpretation. The geometric mean was calculated as the exponential of the arithmetic mean calculated from data on a log scale.|Blood samples were collected from pre-dose (Day -1) up to 72 hours post-dose for each of the separate treatment periods (Visits 2, 3 and 4).|The PK set included all healthy subjects in the safety population (ie, who received at least 1 administration of AZD0585 and for whom any post-dose data were available) with at least 1 detectable total EPA and total DHA plasma concentration.||mg⋅h/mL||Geometric Coefficient of Variation|Geometric Mean
639775|NCT02372344|Primary|The Effect of Food Timing (Fasting, Before Meal, and After Meal) on PK (Cmax) of AZD0585 in Healthy Male Japanese.|To investigate the effect of food timing on PK (maximum plasma concentration [Cmax]) of single dose of 4 g AZD0585 in healthy male Japanese by assessing plasma concentrations of total EPA and total DHA, and PK parameters over time under the three proposed conditions (fasting, before meal, and after meal). Analyses of the outcome measures presented are for baseline-adjusted data for total EPA and DHA since the presence of endogenous levels of these fatty acids would likely contribute to intra-subject variability and affect the analyses and interpretation. The geometric mean was calculated as the exponential of the arithmetic mean calculated from data on a log scale.|Blood samples were collected from pre-dose (Day -1) up to 72 hours post-dose for each of the separate treatment periods (Visits 2, 3 and 4).|The PK set included all healthy subjects in the safety population (ie, who received at least 1 administration of AZD0585 and for whom any post-dose data were available) with at least 1 detectable total EPA and total DHA plasma concentration.||microgram/millilitre (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
639776|NCT02372344|Primary|The Effect of Food Timing (Fasting, Before Meal, and After Meal) on Pharmacokinetics (PK; AUC) of AZD0585 in Healthy Male Japanese.|To investigate the effect of food timing on PK (area under the plasma concentration-time curve from time zero to infinity [AUC]) of single dose of 4 g AZD0585 in healthy male Japanese by assessing plasma concentrations of total eicosapentaenoic acid (EPA) and total docosahexaenoic acid (DHA), and PK parameters over time under the three proposed conditions (fasting, before meal, and after meal).|Blood samples were collected from pre-dose (Day -1) up to 72 hours post-dose for each of the separate treatment periods (Visits 2, 3 and 4).|The PK set included all healthy subjects in the safety population (ie, who received at least 1 administration of AZD0585 and for whom any post-dose data were available) with at least 1 detectable total EPA and total DHA plasma concentration.||milligram x hour /millilitre (mg⋅h/mL)||Geometric Coefficient of Variation|Geometric Mean
639777|NCT02372097|Secondary|Number of Participants Who Had Abnormal and Clinically Significant 12-lead Electrocardiograms (ECG) Findings After Study Drug Administration|Participants whose results of electrocardiograms were judged as abnormal and clinically significant by investigator after study drug administration were counted in this measure.|Baseline up to 7 days after the last dose of study drug (Day 8) in each period|The safety analysis set included all participants who received study drug.||participants|||Number
639778|NCT02372097|Secondary|Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Laboratory Values||Day 1 of Period 1 up to the day of hospital discharge (Day 29) in Period 2|The safety analysis set included all participants who received study drug.||participants|||Number
639779|NCT02372097|Secondary|Number of Participants With TEAEs Related to Body Weight||Day 1 of Period 1 up to the day of hospital discharge (Day 29) in Period 2|The safety analysis set included all participants who received study drug.||participants|||Number
639780|NCT02372097|Secondary|Number of Participants With TEAEs Related to Vital Signs||Day 1 of Period 1 up to the day of hospital discharge (Day 29) in Period 2|The safety analysis set included all participants who received study drug.||participants|||Number
639781|NCT02372097|Secondary|Number of Participants Reporting One or More Treatment-Emergent Adverse Events (TEAEs)|Collection of AEs commenced from the time that the participant was first administered study drug in Period 1 (Day 1). Routine collection of AEs continued until the end (hospital discharge) of Period 2 (Day 29).|Day 1 of Period 1 up to the day of hospital discharge (Day 29) in Period 2|The safety analysis set included all participants who received study drug.||participants|||Number
639782|NCT02372097|Secondary|Apparent Terminal Elimination Rate Constant (λz) for SYR-472Z||Day 1: pre dose (within 3 hours prior to dosing), and at multiple time points (up to 168 hours) post dose in each period|The PK analysis set included all participants who received study drug, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for PK.||per hour(hr-1)||Standard Deviation|Geometric Mean
639783|NCT02372097|Secondary|MRT: Mean Residence Time From Time Zero to Infinity for SYR-472Z||Day 1: pre dose (within 3 hours prior to dosing), and at multiple time points (up to 168 hours) post dose in each period|The PK analysis set included all participants who received study drug, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for PK.||hr||Standard Deviation|Geometric Mean
639784|NCT02372097|Secondary|Tmax: Time to Reach the Cmax for SYR-472Z||Day 1: pre dose (within 3 hours prior to dosing), and at multiple time points (up to 168 hours) post dose in each period|The PK analysis set included all participants who received study drug, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for PK.||hour(hr)||Full Range|Median
639785|NCT02372097|Secondary|AUC(0-inf): Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for SYR-472Z||Day 1: pre dose (within 3 hours prior to dosing), and at multiple time points (up to 168 hours) post dose in each period|The PK analysis set included all participants who received study drug, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for PK.||ng*hr/mL||Standard Deviation|Geometric Mean
639786|NCT02372097|Primary|Cmax: Maximum Observed Plasma Concentration for SYR-472Z||Day 1: pre dose (within 3 hours prior to dosing), and at multiple time points (up to 168 hours) post dose in each period|The PK analysis set included all participants who received study drug, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for PK.||nanogram per milliliter(ng/mL)||Standard Deviation|Geometric Mean
639790|NCT02371876|Secondary|Percent of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding Views/Behaviors Related to Self-Monitoring Blood Glucose|Staff obtained responses from persons with diabetes using short questionnaires to provide feedback on views and behaviors related to managing their diabetes. Subjects could respond 'Strongly Agree' or 'Agree' or 'Neutral' or 'Disagree' or 'Strongly Disagree' or 'No Answer or Not Applicable'. The percents (of subjects who responded) that were 'Strongly Agree','Agree','Neutral' about views/behaviors related to self-monitoring blood glucose were calculated.|1 hour|Percent (of those who responded) who 'Strongly Agree', 'Agree', 'Neutral' was calculated for each statement. Abbreviations used: 'HCP' is HealthCare Professional and 'Acc' is Accuracy||Percentage of Participants Who Responded|||Number
639791|NCT02371876|Secondary|Percent of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding BGMS|Staff obtained responses from persons with diabetes using short questionnaires to provide feedback on instructions for use and the basic operation of the BGMS. Subjects could respond 'Strongly Agree' or 'Agree' or 'Neutral' or 'Disagree' or 'Strongly Disagree'. The percent of subjects who provided responses that were 'Strongly Agree','Agree','Neutral' about each statement was calculated.|1 hour|||Percentage of Participants Who Responded|||Number
639792|NCT02371876|Secondary|Percent of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 12.5mg/dL (<100mg/dL) and Within +/- 12.5% (>=100mg/dL) of Laboratory Glucose Method|Untrained subjects with diabetes self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 12.5mg/dL (<100mg/dL YSI capillary plasma) and +/- 12.5% (>= 100mg/dL YSI capillary plasma).|1 hour|||Percentage of BG Results|||Number
639793|NCT02371876|Secondary|Percent of Venous Blood Glucose (BG) Results Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method|Study staff tested subject venous blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject venous plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 15mg/dL (<100mg/dL YSI venous plasma) and +/- 15% (>= 100mg/dL YSI venous plasma).|1 hour|132 (134-2) Blood glucose results were analyzed. Venipunctures were unsuccessful for two subjects.||Percentage of BG Results|||Number
639794|NCT02371876|Secondary|Percent of Subject Fingerstick Blood Glucose (BG) Results Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method When Tested by Study Staff|Study staff tested subject fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 15mg/dL (<100mg/dL YSI capillary plasma) and +/- 15% (>= 100mg/dL YSI capillary plasma).|1 hour|||Percentage of BG Results|||Number
639795|NCT02371876|Secondary|Percent of Alternate Site Palm Blood Glucose (BG) Results Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method|Untrained subjects with diabetes self-tested Alternate Site (AST) palm blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 15mg/dL (<100mg/dL YSI capillary plasma) and +/- 15% (>= 100mg/dL YSI capillary plasma).|1 hour|126 (134-8) Blood glucose results were analyzed. Four subjects with low blood sugar did not attempt palm testing per protocol. Four subjects had low blood sugar; their palm results were not evaluable per protocol.||Percentage of BG Results|||Number
639796|NCT02371876|Primary|Percent of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method|Untrained subjects with diabetes self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 15mg/dL (<100mg/dL YSI capillary plasma) and +/- 15% (>= 100mg/dL YSI capillary plasma).|1 hour|||Percentage of BG Results|||Number
639797|NCT02371850|Secondary|Area Under the Curve (AUC) Attained With and Without Heating in Each of the Two Nicotine Patches (Reference and Generic)|Area under the curve (AUC) attained with and without heating in each of the two nicotine patches (reference and generic).|Four procedure days for each participant|Data analysis completed for AUC (see below), but not yet for Tmax.||ng*hr/ml||Standard Deviation|Mean
639798|NCT02371850|Primary|Measurement of Maximum Plasma Concentration (Cmax)|The main outcome measure of the study is the measurement of maximum plasma concentration (Cmax)|four procedure days for each participant|Ten adult smokers between 24 and 44 years of age at the time of enrollment completed the study. The clinical study was an single-group, open-label study. Each subject completed 4 study visits where in-vivo nicotine levels were measured using a reference patch (Nicoderm CQ) and a generic patch (Aveva)||ng/ml||Standard Deviation|Mean
639799|NCT02371759|Secondary|Local Postoperative Complications|Postoperative paresthesia by clinical examination|24 hours, 7 days|||Participants|||Count of Participants
639800|NCT02371759|Secondary|Postoperative Analgesia|Number of participants who experienced postoperative pain, VAS, NRS|up to 24 hours after tooth extraction|||Participants|||Count of Participants
639801|NCT02371759|Secondary|Width of Anesthetic Field After Maxillary Infiltration Anesthesia|Soft tissue numbness area determined by pin-prick test after maxillary infiltration anesthesia. Not tested for mandibular ablock anesthesia.|Up to 10 minutes after injection of local anesthesia|||milimeters||Standard Deviation|Mean
639802|NCT02371759|Secondary|Onset of Intraoral Local Anesthesia|Evaluated by pin-prick after subjective feeling of soft tissue numbness appeared after local anesthesia injection|Up to 10 minutes, until subjective feeling of soft tissue numbnes|||minutes||Standard Deviation|Mean
639803|NCT02371759|Primary|Electrocardiogram at 20 Minutes|ECG 15 minutes after local anesthesia injection, 20 minutes after baseline measurement|20th minute|||Participants|||Count of Participants
639804|NCT02371759|Primary|Electrocardiogram at 15 Minutes|ECG 10 minutes after local anesthesia injection, 15 minutes after baseline measurement|15th minute|||Participants|||Count of Participants
664253|NCT01788215|Secondary|Serum Hormone Binding Globulin (SHBG)||week 24|in the sugar pill arm, one participant withdrew at week 12||nmol /L||Standard Deviation|Mean
639822|NCT02371759|Primary|Intensity of Intraoral Local Anesthesia|"Number of participants who reported values > 0 after pin-prick testing, using Visual Analogue Scale (VAS) and Numerical Rating Scale (NRS). VAS is represented by line 100 mm long, with one end marked with 0 and words no pain , while the other end is marked with 100 and words the worst pain imanginable. VRS scale is represented by line 100 mm long, marked with numbers from 0 to 10, where 0 corresponds to no pain, and 10 corresponds to the worst pain imaginable. For both scales, higher scores represent worse outcomes."|Up to 10 minutes after local anesthesia injection|||Participants|||Count of Participants
639823|NCT02371759|Primary|Duration of Intraoral Local Anesthesia|Time until cessation in soft tissue numbness|Up to 6 hours after local anesthesia injection|||minutes||Standard Deviation|Mean
639824|NCT02370914|Primary|A Measure Assessing the Sensitivity and Specificity Rate Based on the Nautilus Neurowave Data|"Sensitivity (also called the true positive rate) measures the proportion of concussed participants that are correctly identified as such by utilizing the information within the Nautilus Neurowave data. Sensitivity (also called the true negative rate) measures the proportion of non-concussed participants that are correctly identified as such by utilizing the information within the Nautilus Neurowave data
The information that is evaluated from within this data is recognized through the computation of two parameters, R1 and R2. Both R1 and R2 are measured by computing the frequency spectrum using an FFT of the Neurowave data and computing a ratio of the signal intensities at specific higher frequencies against specific lower frequencies within that spectrum. Based on this computation, the recorded data is evaluated as coming from a concussed participant if R1 >= 1.0 and R2 >= 0.66 and is considered non-concussed otherwise."|Individual assessments were made within 2 days of recording|Analysis population includes all participants. Some of these participants were were declared concussed by the physician in the team during the course of the season. All baseline recordings were treated as from non-concussed participants.||percentage of concussed participants||95% Confidence Interval|Number
639825|NCT02370667|Secondary|Change in Inflammatory Markers (CRP)|C-reactive protein (CRP) is an important marker of the inflammatory response. This markers will be assessed using standard blood draw and nasal swabs collected by a medical professional. The mean (95% confidence interval) difference in concentration in ug/ml (follow-up - baseline) was computed for each of the three study arms.|Week 1 and Week 13|||Change in ug/ml||95% Confidence Interval|Mean
639826|NCT02370667|Secondary|Change in Inflammatory Markers (IL6, TNF, IL10)|Cytokines interleukin-6 (IL6), tumour necrosis factor (TNF), and interleukin-10 (IL10) are important markers of the inflammatory response. These markers will be assessed using standard blood draw and nasal swabs collected by a medical professional. The mean (95% confidence interval) difference in concentration in pg/ml (follow-up - baseline) was computed for each of the three study arms.|Week 1 and Week 13|For IL10: n=6 (BE), n=8 (TE), n=6 (M)||Change in pg/ml||95% Confidence Interval|Mean
639827|NCT02370667|Secondary|Change in Cartilage Morphology|Cartilage morphology will be assessed in open-sourced and custom programs. Sodium (23Na+) images and T2 mapping will be completed on the 3.0T MR750 DIscovery research-grade scanner. The mean (95% confidence interval) percent change from baseline to follow-up was computed for each of the three study arms.|Week 1 and Week 13|||% Change from Baseline to Follow-up||95% Confidence Interval|Mean
639828|NCT02370667|Secondary|Change in Muscle and Fat Volume|Muscle and fat volumes from magnetic resonance images will be segmented using a custom program. The images will be acquired using a • Iterative Decomposition of water and fat with Echo Asymmetry and Least-squares estimation (IDEAL) sequence on a 3.0T MR750 Discovery research-grade scanner.|Indented to be collected on week 1 and week 13|Data for this outcome measure were not collected.|||||
639829|NCT02370667|Secondary|Change in Cardiovascular Fitness|Cardiovascular fitness will be calculated using the YMCA submaximal cycle ergometry test. Predictions of VO2max will be made from heart rate (measured with a heart rate monitor) and load (Watts).|Intended to be collected on week 1 and week 13|Data for this outcome measure were not collected.|||||
639830|NCT02370667|Secondary|Change in Grip Strength (Relative)|Peak grip strength was assessed using a Jamar hand dynamometer. The hand dynamometer was set to a fixed position and all values of grip force were expressed in kg/kg (grip force/body mass). The mean (95% confidence interval) difference in relative force (follow-up - baseline) was computed for each of the three study arms.|Week 1 and Week 13|Note: only 9 participants were analyzed for the Left Side||Change in kg/kg||95% Confidence Interval|Mean
639831|NCT02370667|Secondary|Change in Grip Strength (Absolute)|Peak grip strength was assessed using a Jamar hand dynamometer. The hand dynamometer was set to a fixed position and all values of grip force were expressed in kg. The mean (95% confidence interval) difference in absolute force (follow-up - baseline) was computed for each of the three study arms.|Week 1 and Week 13|Note: only 9 participants were analyzed for the Left Side||Change in kg||95% Confidence Interval|Mean
639832|NCT02370667|Secondary|Change in Isokinetic Knee Extensor and Flexor Power|The peak isokinetic torque developed during knee extension and flexion at 25% resistance of their maximum voluntary isometric contraction was measured by use of a Biodex System 2 isokinetic dynamometer. The mean (95% confidence interval) difference in power (follow-up - baseline) was computed for each of the three study arms. Data is expressed in W/kg.|Week 1 and Week 13|One participant in TE did not complete the power evaluation.||Change in W/kg||95% Confidence Interval|Mean
639833|NCT02370667|Secondary|Change in Isometric Knee Extensor and Flexor Strength|The peak torque developed during knee extension and flexion during a maximum voluntary isometric contraction was measured by use of a Biodex System 2 isokinetic dynamometer. The mean (95% confidence interval) difference in torque (follow-up - baseline) was computed for each of the three study arms. Data is presented as Nm/kg.|Week 1 and Week 13|||Change in Nm/kg||95% Confidence Interval|Mean
639834|NCT02370667|Secondary|Change in Mobility Performance (Stair Ascent)|Mobility performance was measured using the Stair Ascent Test. For this test, the time taken to ascent nine stairs is recorded. The mean (95% confidence interval) difference in time in seconds (follow-up - baseline) was computed for each of the three study arms.|Week 1 and Week 13|||Change in seconds||95% Confidence Interval|Mean
639835|NCT02370667|Secondary|Change in Mobility Performance (Timed Up and Go Test)|Mobility performance was measured using the Timed Up and Go Test. This test measures the time taken to rise from a standard chair with arm rests, walk 3m, and return to a seated position. This measure has produced reliable and valid data in persons with knee OA. The mean (95% confidence interval) difference in time in seconds (follow-up - baseline) was computed for each of the three study arms.|Week 1 and Week 13|||Change in seconds||95% Confidence Interval|Mean
639836|NCT02370667|Secondary|Change in Mobility Performance (30-second Chair Stand Test)|Mobility performance was measured using the 30-second Chair Stand Test. This test measures the number of times participants can rise and lower from a standard height chair, without using arm rests, in a 30-second period. This measure has produced reliable and valid data in persons with knee OA. The mean (95% confidence interval) difference in number (follow-up - baseline) was computed for each of the three study arms.|Week 1 and Week 13|||Change in number of sit-to-stand cycles||95% Confidence Interval|Mean
639837|NCT02370667|Secondary|Change in Mobility Performance (40m Walk Test)|Mobility performance was measured using the 40m Walk Test. This test measures the time taken to complete a fast-paced 40m walk. This measure has produced reliable and valid data in persons with knee OA. The mean (95% confidence interval) difference in time in seconds (follow-up - baseline) was computed for each of the three study arms.|Week 1 and Week 13|||Change in seconds||95% Confidence Interval|Mean
639838|NCT02370667|Secondary|Change in Mobility Performance (Six-Minute Walk Test)|Mobility performance was measured using the Six-Minute Walk Test. For this test, participants are instructed to walk as far as possible in 6 minutes. The distance covered in 6 minutes is recorded. This measure has produced reliable and valid data in persons with knee OA. The mean (95% confidence interval) difference in distance in metres (follow-up - baseline) was computed for each of the three study arms.|Week 1 and Week 13|||Change in metres||95% Confidence Interval|Mean
639839|NCT02370667|Secondary|Change in Frailty Status|Frailty was assessed using the Edmonton Frail Scale (EFS). The EFS is a brief screening interview for older adults to assess frailty that is commonly used in both inpatient and outpatient settings. The scale covers 8 domains: cognition, general health status, functional independence, social support, medication use, nutrition, mood, continence, and functional performance (defined as performance on the Timed Up and Go [TUG] test). The test is scored out of 17, with higher scores indicating higher levels of frailty. The mean (95% confidence interval) difference score (follow-up score - baseline score) was computed for each of the three study arms.|Week 1 and Week 13|||Change in scores on a scale||Full Range|Mean
639840|NCT02370667|Secondary|Change in Depression Status|Depression was assessed with the Centre of Epidemiological Studies Depression (CES-D) Scale, a 20-item scale developed for the general population with emphasis on affect. Elements of affect include mood, guilt, worthlessness, helplessness, appetite, and sleep. The CES-D is scored from 0 to 60 with a score of 16 or higher indicating depression. The mean (95% confidence interval) difference score (follow-up score - baseline score) was computed for each of the three study arms.|Week 1 and Week 13|||Change in scores on a scale||95% Confidence Interval|Mean
639841|NCT02370667|Secondary|Change in Arthritis-related Self-efficacy|The Arthritis Self-Efficacy Scale (ASES) measures arthritis-specific beliefs regarding perception of performance on certain tasks to cope with the disease. The ASES is measured using 20 questions on a 10-100 scale with respect to three main areas: pain management (5 questions), physical function (9 questions), and other symptoms (6 questions). Higher numbers indicate greater certainty that a participant can cope with a particular task as a consequence of their disease. The mean (95% confidence interval) difference score (follow-up score - baseline score) was computed for each of the three study arms.|Week 1 and Week 13|||Change in scores on a scale||95% Confidence Interval|Mean
639842|NCT02370667|Secondary|Change in Self-reported Knee Pain|Change in self-reported knee pain was assessed with 3 valid and reliable questionnaires: the Knee injury and Osteoarthritis Outcome Score (KOOS), the Intermittent and Constant Osteoarthritis Pain (ICOAP) score, and the Numeric Pain Rating Scale (NPRS). The KOOS pain score represents a normalized score from 0 (extreme symptoms) to 100 (no symptoms). KOOS scores closer to 100 indicate fewer symptoms. The ICOAP consists of two sub-scales: constant pain (5 items) and intermittent pain (6 items). The score from each subscale represents a normalized score from 0 (no pain) to 100 (extreme pain). ICOAP scores closer to 0 indicate less pain. The NPRS pain score represents a score from 0 (no pain) to 10 (worst possible pain). NPRS ratings were provided following maximum isometric knee extensor exertions and flexor exertions. The mean (95% confidence interval) difference score (follow-up score - baseline score) was computed for each of the three study arms.|Week 1 and Week 13|||Change in scores on a scale||95% Confidence Interval|Mean
639843|NCT02370667|Primary|Change in Lower Extremity Function|The Lower Extremity Function Scale (LEFS) consists of 20 items, on an adjectival scale, that assess difficulty during mobility tasks ranging from transfers to running. The LEFS is scored from 0 to 80 with higher scores represent better self-reported physical function. It is reliable and valid in knee OA and has superior sensitivity to change compared to similar measures. The mean (95% confidence interval) difference score (follow-up score - baseline score) was computed for each of the three study arms.|Week 1 and Week 13|||Change in scores on a scale||95% Confidence Interval|Mean
639844|NCT02370615|Primary|Number of Participants With Clinically Significant Change From Baseline in Continuous Pulse Oximetry (SpO2) in Cohort 2||Cohort 2: Baseline up to Day 15|The safety analysis set was defined as all participants who received at least one dose of study drug.||participants|||Number
639845|NCT02370615|Primary|Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis||Cohort 1: Baseline up to Day 19; Cohort 2: Baseline up to Day 15|The safety analysis set was defined as all participants who received at least one dose of study drug.||participants|||Number
639846|NCT02370615|Primary|Number of Participants Who Had Clinically Significant Changes From Baseline in 12-lead Electrocardiograms|Number of participants who had ECG findings changed from “within normal limit” or “abnormal, clinically significant” to “abnormal and clinically significant” after study drug administration.|Cohort 1: Baseline up to Day 19; Cohort 2: Baseline up to Day 15|The safety analysis set was defined as all participants who received at least one dose of study drug.||participants|||Number
639847|NCT02370615|Primary|Number of Participants With TEAEs Related to Body Weight||Cohort 1: Baseline up to Day 19; Cohort 2: Baseline up to Day 15|The safety analysis set was defined as all participants who received at least one dose of study drug.||participants|||Number
639848|NCT02370615|Primary|Number of Participants With TEAEs Related to Vital Signs||Cohort 1: Baseline up to Day 19; Cohort 2: Baseline up to Day 15|The safety analysis set was defined as all participants who received at least one dose of study drug.||participants|||Number
639849|NCT02370615|Primary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)||Cohort 1: Baseline up to Day 19; Cohort 2: Baseline up to Day 15|The safety analysis set was defined as all participants who received at least one dose of study drug.||participants|||Number
639850|NCT02370615|Primary|AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Midazolam and 1’Hydroxymidazolam in Cohort 2||Day 1 and Day 7: pre-dose and at multiple time-points (upto 24 hours) postdose; Day 1 for Cohort 2: Midazolam and Day 7 for Cohort 2: Midazolam + TAK-272|The pharmacokinetic analysis set was defined as the set of participants treated with the study drug that had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for pharmacokinetics.||ng*hr/mL||Standard Deviation|Geometric Mean
639851|NCT02370615|Primary|AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Midazolam and 1’Hydroxymidazolam in Cohort 2||Day 1 and Day 7: pre-dose and at multiple time-points (upto 24 hours) postdose; Day 1 for Cohort 2: Midazolam and Day 7 for Cohort 2: Midazolam + TAK-272|The pharmacokinetic analysis set was defined as the set of participants treated with the study drug that had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for pharmacokinetics.||ng*hr/mL||Standard Deviation|Geometric Mean
639852|NCT02370615|Primary|Cmax: Maximum Observed Plasma Concentration for Midazolam and 1’Hydroxymidazolam in Cohort 2||Day 1 and Day 7: pre-dose and at multiple time-points (upto 24 hours) postdose; Day 1 for Cohort 2: Midazolam and Day 7 for Cohort 2: Midazolam + TAK-272|The pharmacokinetic analysis set was defined as the set of participants treated with the study drug that had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for pharmacokinetics.||ng/mL||Standard Deviation|Geometric Mean
639853|NCT02370615|Primary|Urinary Excretion Ratio of Digoxin From 0 to 48 Hours Postdose in Cohort 2||Day 1 and Day 7: pre-dose and at multiple time-points (upto 48 hours) postdose; Day 1 for Cohort 2: Digoxin and Day 7 for Cohort 2: Digoxin + TAK-272|The pharmacokinetic analysis set was defined as the set of participants treated with the study drug that had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for pharmacokinetics.||percentage of dose||Standard Deviation|Mean
639854|NCT02370615|Primary|AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Digoxin in Cohort 2||Day 1 and Day 7: pre-dose and at multiple time-points (upto 48 hours) postdose; Day 1 for Cohort 2: Digoxin and Day 7 for Cohort 2: Digoxin + TAK-272|The pharmacokinetic analysis set was defined as the set of participants treated with the study drug that had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for pharmacokinetics.||ng*hr/mL||Standard Deviation|Geometric Mean
639855|NCT02370615|Primary|AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Digoxin in Cohort 2||Day 1 and Day 7: pre-dose and at multiple time-points (upto 48 hours) postdose; Day 1 for Cohort 2: Digoxin and Day 7 for Cohort 2: Digoxin + TAK-272|The pharmacokinetic analysis set was defined as the set of participants treated with the study drug that had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for pharmacokinetics.||ng*hr/mL||Standard Deviation|Geometric Mean
639856|NCT02370615|Primary|Cmax: Maximum Observed Plasma Concentration for Digoxin in Cohort 2||Day 1 and Day 7: pre-dose and at multiple time-points (upto 48 hours) postdose; Day 1 for Cohort 2: Digoxin and Day 7 for Cohort 2: Digoxin + TAK-272|The pharmacokinetic analysis set was defined as the set of participants treated with the study drug that had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for pharmacokinetics.||ng/mL||Standard Deviation|Geometric Mean
639857|NCT02370615|Primary|Cumulative Urinary Excretion Ratio of TAK 272F and TAK 272-M-I From 0 to 72 Hours Postdose in Cohort 1||Day 1 and Day 10: pre-dose and at multiple time-points (upto 72 hours) postdose; Day 1 for Cohort 1: TAK-272 and Day 10 for Cohort 1: TAK-272 + Itraconazole|The pharmacokinetic analysis set was defined as the set of participants treated with the study drug that had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for pharmacokinetics.||percentage of dose||Standard Deviation|Mean
639858|NCT02370615|Primary|AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK 272F and TAK 272-M-I in Cohort 1||Day 1 and Day 10: pre-dose and at multiple time-points (upto 72 hours) postdose; Day 1 for Cohort 1: TAK-272 and Day 10 for Cohort 1: TAK-272 + Itraconazole|The pharmacokinetic analysis set was defined as the set of participants treated with the study drug that had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for pharmacokinetics.||ng*hr/mL||Standard Deviation|Geometric Mean
639859|NCT02370615|Primary|AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK 272F and TAK 272-M-I in Cohort 1||Day 1 and Day 10: pre-dose and at multiple time-points (upto 72 hours) postdose; Day 1 for Cohort 1: TAK-272 and Day 10 for Cohort 1: TAK-272 + Itraconazole|The pharmacokinetic analysis set was defined as the set of participants treated with the study drug that had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for pharmacokinetics.||nanogram hours per milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
639860|NCT02370615|Primary|Cmax: Maximum Observed Plasma Concentration for TAK 272F and TAK 272-Metabolite (M-I) in Cohort 1||Day 1 and Day 10: pre-dose and at multiple time-points (upto 72 hours) postdose; Day 1 for Cohort 1: TAK-272 and Day 10 for Cohort 1: TAK-272 + Itraconazole|The pharmacokinetic analysis set was defined as the set of participants treated with the study drug that had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for pharmacokinetics.||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
639861|NCT02370602|Secondary|Cavg During the Positron Emission Tomography (PET) Scan Period (AUC(Scan)) at 23 Hours Post-dose for TAK-063 and TAK-063 Metabolite M-I|Cavg values of TAK-063 and TAK-063 metabolite M-I during the PET scan at approximately 23 hours post TAK-063 administration. Data is not available for the pilot cohort.|23 hours post-dose|Pharmacokinetic Analysis Set||ng/mL||Standard Deviation|Mean
639862|NCT02370602|Secondary|AUC During the Positron Emission Tomography (PET) Scan Period (AUC(Scan)) at 23 Hours Post-dose for TAK-063 and TAK-063 Metabolite M-I|AUC values of TAK-063 and TAK-063 metabolite M-I during the PET scan at approximately 23 hours post TAK-063 administration. Data was not available for participants in the pilot cohort.|23 hours post-dose|Pharmacokinetic Analysis Set||ng*hr/mL||Standard Deviation|Mean
639863|NCT02370602|Secondary|Cavg During the Positron Emission Tomography (PET) Scan Period (AUC(Scan)) at 3 Hours Post-dose for TAK-063 and TAK-063 Metabolite M-I|Cavg values of TAK-063 and TAK-063 metabolite M-I during the PET scan at approximately 3 hours post TAK-063 administration.|3 hours post-dose|Pharmacokinetic Analysis Set||ng/mL||Standard Deviation|Mean
639864|NCT02370602|Secondary|AUC During the Positron Emission Tomography (PET) Scan Period (AUC(Scan)) at 3 Hours Post-dose for TAK-063 and TAK-063 Metabolite M-I|AUC values of TAK-063 and TAK-063 metabolite M-I during the PET scan at approximately 3 hours post TAK-063 administration.|3 hours post-dose|Pharmacokinetic Analysis Set||ng*hr/mL||Standard Deviation|Mean
639865|NCT02370602|Secondary|Ratio of TAK-063 Metabolite M-I AUC( 0-24) to TAK-063 AUC (0-24)|AUC Ratio is the ratio of AUC values of the metabolite compared to the parent calculated by dividing AUC values of metabolite M-I with those of the parent drug TAK-063.|Pilot Cohort: Day 2 predose and at multiple time points (up to 24 hours) post-dose. Main Cohort: Day 1 predose and at multiple time points (up to 24 hours) post-dose.|Pharmacokinetic Analysis Set||ratio||Standard Deviation|Mean
639866|NCT02370602|Secondary|Ratio of TAK-063 Metabolite Cmax to TAK-063 Cmax|Cmax Ratio is the ratio of Cmax values of the metabolite compared to the parent calculated by dividing Cmax values of metabolite M-I with those of the parent drug TAK-063.|Pilot Cohort: Day 2 predose and at multiple time points (up to 24 hours) post-dose. Main Cohort: Day 1 predose and at multiple time points (up to 24 hours) post-dose.|Pharmacokinetic Analysis Set||ratio||Standard Deviation|Mean
639867|NCT02370602|Secondary|CL/F: Oral Clearance of TAK-063|CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided by area under the curve from time 0 to 24 hours post-dose, after multiple dosing (at steady state).|Pilot Cohort: Day 2 predose and at multiple time points (up to 24 hours) post-dose. Main Cohort: Day 1 predose and at multiple time points (up to 24 hours) post-dose.|Pharmacokinetic Analysis Set||liter/hour||Standard Deviation|Mean
639868|NCT02370602|Secondary|Average Plasma Concentration on Day 1 (Cavg) for TAK-063 and TAK-063 Metabolite M-I|Cavg is the average plasma concentration on Day 1, calculated as AUC(0-24)/24.|Pilot Cohort: Day 2 predose and at multiple time points (up to 24 hours) post-dose. Main Cohort: Day 1 predose and at multiple time points (up to 24 hours) post-dose.|Pharmacokinetic Analysis Set||ng/mL||Standard Deviation|Mean
639869|NCT02370602|Secondary|AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Postdose for TAK-063 and TAK-063 Metabolite M-I|AUC(0-24) is a measure of total plasma exposure to the drug from Time 0 to 24 hours post-dose.|Pilot Cohort: Day 2 predose and at multiple time points (up to 24 hours) post-dose. Main Cohort: Day 1 predose and at multiple time points (up to 24 hours) post-dose.|Pharmacokinetic Analysis Set||ng*hr/mL||Standard Deviation|Mean
639870|NCT02370602|Secondary|AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-063 and TAK-063 Metabolite M-I|(AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]).|Pilot Cohort: Day 2 predose and at multiple time points (up to 24 hours) post-dose. Main Cohort: Day 1 predose and at multiple time points (up to 24 hours) post-dose.|Pharmacokinetic Analysis Set||ng*hr/mL||Standard Deviation|Mean
639871|NCT02370602|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-063 and TAK-063 Metabolite M-I|Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.|Pilot Cohort: Day 2 predose and at multiple time points (up to 24 hours) post-dose. Main Cohort: Day 1 predose and at multiple time points (up to 24 hours) post-dose.|Pharmacokinetic Analysis Set||hour||Standard Deviation|Mean
639872|NCT02370602|Secondary|Cmax: Maximum Observed Plasma Concentration for TAK-063 and TAK-063 Metabolite M-I|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Pilot Cohort: Day 2 predose and at multiple time points (up to 24 hours) post-dose. Main Cohort: Day 1 predose and at multiple time points (up to 24 hours) post-dose.|Pharmacokinetic Analysis Set||ng/mL||Standard Deviation|Mean
639873|NCT02370602|Secondary|Percentage of Participants With Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters|"The percentage of participants with any markedly abnormal standard 12-lead ECG measurements.
QTc - Bazett's Interval (msec) is ≥500 msec OR ≥30 msec change from Baseline and ≥450 msec"|From Day 1 to Day 16|Safety analysis set included all participants who received at least one dose of study drug.||percentage of participants|||Number
639874|NCT02370602|Secondary|Percentage of Participants With Markedly Abnormal Vital Sign Measurements|The percentage of participants with any markedly abnormal standard vital sign measurements was collected throughout study. BL=baseline. bpm=beats per minute.|From Day 1 to Day 16|Safety analysis set included all participants who received at least one dose of study drug.||percentage of participants|||Number
639875|NCT02370602|Secondary|Percentage of Participants With Markedly Abnormal Safety Laboratory Findings|The percentage of participants with any markedly abnormal standard safety laboratory values was collected throughout study.|From Day 1 to Day 16|Safety analysis set included all participants who received at least one dose of study drug.||percentage of participants|||Number
639876|NCT02370602|Secondary|Percentage of Participants Who Experienced at Least 1 Treatment-Emergent Adverse Event|An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event is defined as an adverse event with an onset that occurs after receiving study drug.|First dose of study drug to 30 days after last dose of study drug (up to 46 days)|Safety analysis set included all participants who received at least one dose of study drug.||percentage of participants|||Number
639877|NCT02370602|Secondary|Phosphodiesterase 10A (PDE10A) Occupancy of Brain Regions With [^11C]T-773 at 23 Hours Following a Single Dose of TAK-063|Volume of tissue distribution (Vt) values will be estimated by several quantitative methods for each positron emission tomography (PET) scan. Based on the change in Vt before and after TAK-063 administration, PDE10A occupancy will be calculated. PET scan #2 in the Pilot Cohort and PET scan #1 in the Main Cohort will be used as a baseline for the occupancy calculation. Data was not available for participants in the pilot cohort. Occupancy is reported for putamen only.|23 hours post-dose|Pharmacodynamic Analysis Set includes all participants with data available for pharmacodynamic analysis.||Percent||Standard Deviation|Mean
639892|NCT02370407|Primary|Global Rating Scale Score on the Robotic Task|A composite score of (1) depth perception, (2) bimanual dexterity, (3) efficiency, (4) tissue handling, (5) time and motion, (6) instrument handling, and (7) flow of operation, each scored 1 through 5 on an anchored Likert scale where higher scores indicated improved proficiency. Point range 7 – 35.|Study duration|||units on a scale||Standard Deviation|Mean
639878|NCT02370602|Primary|Phosphodiesterase 10A (PDE10A) Occupancy of Brain Regions With [^11C]T-773 at 3 Hours Following a Single Dose of TAK-063|Volume of tissue distribution (Vt) values will be estimated by several quantitative methods for each positron emission tomography (PET) scan. Based on the change in Vt before and after TAK-063 administration, PDE10A occupancy will be calculated. PET scan #2 in the Pilot Cohort and PET scan #1 in the Main Cohort will be used as a baseline for the occupancy calculation. Occupancy is reported for putamen only.|3 hours post-dose|Pharmacodynamic Analysis Set includes all participants with data available for pharmacodynamic analysis..||Percent||Standard Deviation|Mean
639879|NCT02370537|Primary|Part B: Baseline Corrected Cmax for Total EPA+DHA Following Administration of EPANOVA® and OMACOR®.|Baseline corrected Cmax was measured for the sum of EPA and DHA (total EPA+DHA) following administration of single oral doses of EPANOVA® 4 g (A) and OMACOR® 4 g (B) (2-way crossover design) to patients with T2DM and different degrees of PEI.|Blood samples for analysis were taken at 1, 0.5, and 0.05 hours pre-dose, to be used as baseline, and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 24 and 48 hours post-dose.|The PK Analysis Set included all randomised patients who received at least one dose of study treatment in Part B and had at least one post-dose PK measurement without any protocol deviations.||nmol/mL||Geometric Coefficient of Variation|Geometric Mean
639880|NCT02370537|Primary|Part B: Baseline Corrected Cmax for Total DHA Following Administration of EPANOVA® and OMACOR®.|Baseline corrected Cmax was measured for total DHA following administration of single oral doses of EPANOVA® 4 g (A) and OMACOR® 4 g (B) (2-way crossover design) to patients with T2DM and different degrees of PEI.|Blood samples for analysis were taken at 1, 0.5, and 0.05 hours pre-dose, to be used as baseline, and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 24 and 48 hours post-dose.|The PK Analysis Set included all randomised patients who received at least one dose of study treatment in Part B and had at least one post-dose PK measurement without any protocol deviations.||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
639881|NCT02370537|Primary|Part B: Baseline Corrected Maximum Plasma Drug Concentration (Cmax) for Total EPA Following Administration of EPANOVA® and OMACOR®.|Baseline corrected Cmax was measured for total EPA following administration of single oral doses of EPANOVA® 4 g (A) and OMACOR® 4 g (B) (2-way crossover design) to patients with T2DM and different degrees of PEI.|Blood samples for analysis were taken at 1, 0.5, and 0.05 hours pre-dose, to be used as baseline, and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 24 and 48 hours post-dose.|The PK Analysis Set included all randomised patients who received at least one dose of study treatment in Part B and had at least one post-dose PK measurement without any important protocol deviations.||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
639882|NCT02370537|Primary|Part B: Baseline Corrected AUC(0-last) for Total EPA+DHA Following Administration of EPANOVA® and OMACOR®.|Baseline corrected AUC(0-last) was measured for the sum of EPA and DHA (total EPA+DHA) following administration of single oral doses of EPANOVA® 4 g (A) and OMACOR® 4 g (B) (2-way crossover design) to patients with T2DM and different degrees of PEI.|Blood samples for analysis were taken at 1, 0.5, and 0.05 hours pre-dose, to be used as baseline, and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 24 and 48 hours post-dose.|The PK Analysis Set included all randomised patients who received at least one dose of study treatment in Part B and had at least one post-dose PK measurement without any protocol deviations. 3 subjects were excluded from the analysis for AUC(0-last) due to missing sample results at 48 hours.||h*nanomole/mL (h*nmol/mL)||Geometric Coefficient of Variation|Geometric Mean
639883|NCT02370537|Primary|Part B: Baseline Corrected AUC(0-last) for Total Docosahexaenoic Acid (DHA) Following Administration of EPANOVA® and OMACOR®.|Baseline corrected AUC(0-last) was measured for total DHA following administration of single oral doses of EPANOVA® 4 g (A) and OMACOR® 4 g (B) (2-way crossover design) to patients with T2DM and different degrees of PEI.|Blood samples for analysis were taken at 1, 0.5, and 0.05 hours pre-dose, to be used as baseline, and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 24 and 48 hours post-dose.|The PK Analysis Set included all randomised patients who received at least one dose of study treatment in Part B and had at least one post-dose PK measurement without any protocol deviations. 3 subjects were excluded from the analysis for AUC(0-last) due to missing sample results at 48 hours.||h*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
639884|NCT02370537|Primary|Part B: Baseline Corrected Area Under the Plasma Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC[0-last]) for Total Eicosapentaenoic Acid (EPA) Following Administration of EPANOVA® and OMACOR®.|Baseline corrected AUC(0-last) was measured for total EPA following administration of single oral doses of EPANOVA® 4 g (A) and OMACOR® 4 g (B) (2-way crossover design) to patients with T2DM and different degrees of PEI.|Blood samples for analysis were taken at 1, 0.5, and 0.05 hours pre-dose, to be used as baseline, and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 24 and 48 hours post-dose.|The Pharmacokinetic (PK) Analysis Set included all randomised patients who received at least one dose of study treatment in Part B and had at least one post-dose PK measurement without any important protocol deviations. 3 subjects were excluded from the analysis for AUC(0-last) due to missing sample results at 48 hours.||hours*mcg per millilitre (h*mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
639885|NCT02370537|Primary|Part A: Serum TG Level.|For Part A, the distribution of serum TG levels by the degree of pancreatic exocrine insufficiency (PEI) was assessed in patients with Type 2 Diabetes Mellitus (T2DM).|7 days after enrollment.|The Per Protocol Analysis Set included all enrolled patients without an important protocol deviation.||millimole per litre (mmol/L)||Standard Deviation|Mean
639886|NCT02370407|Secondary|Workspace Range|Automatically recorded data on the Mimic DV trainer consisting of workspace range (cm, this is the widest range traveled by the 2 instruments, one in each hand), and number of peg drops|study duration|||cm||Standard Deviation|Mean
639887|NCT02370407|Secondary|Time Spent Using Excessive Force|Automatically recorded data on the Mimic DV trainer (seconds)|study duration|||seconds||Standard Deviation|Mean
639888|NCT02370407|Secondary|Instrument Collisions|Automatically recorded data on the Mimic DV trainer which records number of collisions|study duration|||number of events||Standard Deviation|Mean
639889|NCT02370407|Secondary|Instrument Out of View|Automatically recorded data on the Mimic DV trainer, (sec). The longer out of view indicates decreased proficiency|through study completion|||seconds||Standard Deviation|Mean
639890|NCT02370407|Secondary|Economy of Motion on the Robotic Task|(cm, where lower measurements represent improved economy of motion). This measures how many cm the instruments traveled in order to accomplish the task|Study duration|||cm||Standard Deviation|Mean
639891|NCT02370407|Primary|Time to Task Completion on the Laparoscopic Task|Time to task completion (seconds) on the laparoscopic task|1 day of practice|||seconds||Standard Deviation|Mean
639893|NCT02370407|Primary|Global Rating Scale Score on the Laparoscopic Task|Global rating scale score on the laparoscopic task. A composite score of (1) depth perception, (2) bimanual dexterity, (3) efficiency, (4) tissue handling, (5) time and motion, (6) instrument handling, and (7) flow of operation, each scored 1 through 5 on an anchored Likert scale where higher scores indicated improved proficiency. Point range 7 – 35.|Study duration|||units on a scale||Standard Deviation|Mean
639894|NCT02370407|Primary|Time to Task Completion (Robotic Task)|Primary outcome will be time to task completion (seconds) on the robotic task|1 day of practice|||seconds||Standard Deviation|Mean
639895|NCT02370121|Secondary|Area Under the Curve of Insulin (AUCI)|The estimation for AUCI was calculated from parameters obtained during the 2 hours oral glucose tolerant test (OGTT) with 75 g dextrose by trapezoidal integration. The value was expressed on pmol/L/min.|week 12|||pmol/L/min||Standard Deviation|Mean
639896|NCT02370121|Secondary|Area Under the Curve of Glucose (AUCG)|The estimation for AUCG was calculated from parameters obtained during the 2 hours oral glucose tolerant test (OGTT) with 75 g dextrose by trapezoidal integration. The value was expressed mmol/L/min.|week 12|||mmol/L/min||Standard Deviation|Mean
639897|NCT02370121|Secondary|2-hour Postload Plasma Glucose (2-h PG)|The blood sample for determining of 2-h PG, was taken two hours after the ingestion of the drink with 75 g dextrose and was evaluated by spectrophotometry method. The value was expressed on mmol/L.|week 12|||mmol/L||Standard Deviation|Mean
639898|NCT02370121|Secondary|Very-low Density Lipoprotein (VLDL)|The blood sample for determining the VLDL, was taken after an overnight fast and was calculated as triglycerides/5. The value was expressed on mmol/L.|week 12|||mmol/L||Standard Deviation|Mean
639899|NCT02370121|Secondary|Low-density Lipoprotein Cholesterol (LDL-C)|The blood sample for determining of LDL-C, was taken after an overnight fast and was calculated by Friedewald formula. The value was expressed on mmol/L.|Week 12|||mmol/L||Standard Deviation|Mean
639900|NCT02370121|Secondary|Total Cholesterol (TC)|The blood sample for determining of TC, was taken after an overnight fast and was evaluated by spectrophotometry method. The value was expressed on mmol/L.|week 12|||mmol/L||Standard Deviation|Mean
639901|NCT02370121|Secondary|Body Mass Index (BMI)|The BMI was calculated by the square of the body height, and is universally expressed in units of kg/m2, resulting from mass in kilograms and height in metres.|week 12|||kg/m^2||Standard Deviation|Mean
639902|NCT02370121|Secondary|Body Weight (BW)|The BW was evaluated after an overnight fast, through a bioimpedance digital scale results are reported in kilograms with a decimal.|week 12|||kg||Standard Deviation|Mean
639903|NCT02370121|Primary|Insulin Sensitivity|The insulin sensitivity was calculated with Matsuda index [10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)].|week 12|||unitless||Standard Deviation|Mean
639904|NCT02370121|Primary|First Phase of Insulin Secretion|The first phase of insulin secretion was estimated using the Stumvoll index (1283+ 1.829 x insulin 30' - 138.7 x glucose 30' + 3.772 x insulin 0').|week 12|||unitless||Standard Deviation|Mean
639905|NCT02370121|Primary|Total Insulin Secretion|The total insulin secretion was calculated by the insulinogenic index (ΔABC insulin / ΔABC glucose).|Week 12|||unitless||Standard Deviation|Mean
639906|NCT02370121|Primary|Diastolic Blood Pressure (DBP)|The DBP was evaluated with a digital sphygmomanometer with the subject sited down on a chair after a resting period of 5 minutes on three occasions. The mean of the three measures was considered as the value of DBP. The value was expressed on mmHg.|week 12|||mmHg||Standard Deviation|Mean
639907|NCT02370121|Primary|Systolic Blood Pressure (SBP)|The SBP was evaluated with a digital sphygmomanometer with the subject sited down on a chair after a resting period of 5 minutes on three occasions. The mean of the three measures was considered as the value of SBP. The value was expressed on mmHg.|week 12|||mmHg||Standard Deviation|Mean
639908|NCT02370121|Primary|Fasting Plasma Glucose (FPG)|The blood sample for determining of FPG, was taken after an overnight fast and was evaluated by spectrophotometry method. The value was expressed on mmol/L.|week 12|||mmol/L||Standard Deviation|Mean
639909|NCT02370121|Primary|High-density Lipoprotein Cholesterol (HDL-C)|The blood sample for determining of HDL-C, was taken after an overnight fast and was evaluated by colorimetric method. The value was expressed on mmol/L.|Week 12|||mmol/L||Standard Deviation|Mean
639910|NCT02370121|Primary|Triglycerides (TGs)|The blood sample for determining of TGs, was taken after an overnight fast and was evaluated by spectrophotometry method. The value was expressed on mmol/L.|week 12|||mmol/L||Standard Deviation|Mean
639911|NCT02370121|Primary|Waist Circumference (WC)|The WC was evaluated after an overnight fast with a flexible tape in the midpoint between the lowest rib and the iliac crest and is expressed in centimeters.|Week 12|All participants, including those who dropped out before the end were taken into account for statical analysis (intention to treat).||cm||Standard Deviation|Mean
639912|NCT02369796|Secondary|Mean Terminal Phase Elimination Half-life (T1/2) for TAK-448F|Terminal Phase Elimination Half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.|Day 1 and Day 22 pre-dose and at multiple time points (up to 8 hours) post-dose|Pharmacokinetic (PK) set included all participants who received at least one dose of study drug and had at least 1 measurable concentration of TAK-448F. Here, 'n' is the participants who were analyzed at specific time point.||hr||Standard Deviation|Mean
639913|NCT02369796|Secondary|AUC(0-tlqc): Mean Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-448F|AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]).|Day 1 and Day 22 pre-dose and at multiple time points (up to 8 hours) post-dose|PK set included all participants who received at least one dose of study drug and had at least 1 measurable concentration of TAK-448F.||pg*hr/mL||Standard Deviation|Mean
639914|NCT02369796|Secondary|AUC(0-∞): Mean Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-448F|AUC(0-∞) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.|Day 1 and Day 22 pre-dose and at multiple time points (up to 8 hours) post-dose|PK set included all participants who received at least one dose of study drug and had at least 1 measurable concentration of TAK-448F. Here, 'n' is the participants who were analyzed at specific time point.||pg*hr/mL||Standard Deviation|Mean
640403|NCT02353442|Secondary|Strength of the Shoulder External Rotators at 4weeks (Pre and Post Treatment).|The strength was evaluated with digital dynamometer in Newton pre and post treatment.|4 weeks: Baseline (pre-treatment), and 4 weeks (post-treatment)|||Newton||Standard Deviation|Mean
639915|NCT02369796|Secondary|Cmax: Mean Maximum Observed Plasma Concentration for TAK-448 Free Base Form (TAK-448F)|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Day 1 and Day 22 pre-dose and at multiple time points (up to 8 hours) post-dose|Pharmacokinetic (PK) set included all participants who received at least one dose of study drug and had at least 1 measurable concentration of TAK-448F.||pg/mL||Standard Deviation|Mean
639916|NCT02369796|Primary|Trough Serum Concentration (Ctrough) of Free Serum Testosterone for Twice Weekly Dosing Groups|Trough serum concentration of free ST, defined as lowest baseline concentration compared to pre-dose of the last dose.|Day 25 pre-dose|PD set included all participants who received at least one dose of study drug and had at least 1 valid PD measure.||nmol/L||Standard Deviation|Mean
639917|NCT02369796|Primary|Trough Serum Concentration (Ctrough) of Free Serum Testosterone for Once Weekly Dosing Groups|Trough serum concentration of free ST, defined as lowest baseline concentration compared to pre-dose of the last dose.|Day 22 pre-dose|PD set included all participants who received at least one dose of study drug and had at least 1 valid PD measure. Number of participants analyzed is number of participants evaluated for this outcome measure.||nmol/L||Standard Deviation|Mean
639918|NCT02369796|Primary|Trough Serum Concentration (Ctrough) of Total Serum Testosterone for Twice Weekly Dosing Group|Trough serum concentration of total ST, defined as lowest baseline concentration compared to pre-dose of the last dose.|Day 25 pre-dose|PD set included all participants who received at least one dose of study drug and had at least 1 valid PD measure.||nmol/L||Standard Deviation|Mean
639919|NCT02369796|Primary|Trough Serum Concentration (Ctrough) of Total Serum Testosterone for Once Weekly Dosing Groups|Trough serum concentration of total ST, defined as lowest baseline concentration compared to pre-dose of the last dose.|Day 22 pre-dose|PD set included all participants who received at least one dose of study drug and had at least 1 valid PD measure.||nmol/L||Standard Deviation|Mean
639920|NCT02369796|Primary|Percent Change From Baseline in Mean Area Under the Effect Curve From Time 0 to 72 Hours (AUEC72) of Free Serum Testosterone for Twice Weekly Dosing Groups|Area under the PD free ST concentration-time curve from the time 0 to 72 hours, calculated using the linear trapezoidal rule for baseline profile and those obtained after first and last dose.|Baseline and Day 25 pre-dose and multiple time points (up to 72 hours) post dose|PD set included all participants who received at least one dose of study drug and had at least 1 valid PD measure.||percent change||Standard Deviation|Mean
639921|NCT02369796|Primary|Percent Change From Baseline in Mean Area Under the Effect Curve From Time 0 to 72 Hours (AUEC72) of Free Serum Testosterone for Once Weekly Dosing Groups|Area under the PD free ST concentration-time curve from the time 0 to 72 hours, calculated using the linear trapezoidal rule for baseline profile and those obtained after first and last dose.|Baseline and Day 22 pre-dose and multiple time points (up to 72 hours) post dose|PD set included all participants who received at least one dose of study drug and had at least 1 valid PD measure.||percent change||Standard Deviation|Mean
639922|NCT02369796|Primary|Percent Change From Baseline in Mean Area Under the Effect Curve From Time 0 to 72 Hours (AUEC72) of Total Serum Testosterone for Twice Weekly Dosing Groups|Area under the PD total ST concentration-time curve from the time 0 to 72 hours, calculated using the linear trapezoidal rule for baseline profile and those obtained after first and last dose.|Baseline and Day 25 pre-dose and multiple time points (up to 72 hours) post dose|PD set included all participants who received at least one dose of study drug and had at least 1 valid PD measure.||percent change||Standard Deviation|Mean
639923|NCT02369796|Primary|Percent Change From Baseline in Mean Area Under the Effect Curve From Time 0 to 72 Hours (AUEC72) of Total Serum Testosterone for Once Weekly Dosing Groups|Area under the pharmacodynamic (PD) total serum testosterone (ST) concentration-time curve from the time 0 to 72 hours, calculated using the linear trapezoidal rule for baseline profile and those obtained after first and last dose.|Baseline and Day 22 pre-dose and multiple time points (up to 72 hours) post dose|PD set included all participants who received at least one dose of study drug and had at least 1 valid PD measure.||percent change||Standard Deviation|Mean
639924|NCT02369510|Secondary|Incidence of Pruritus|data not collected|up to 3 hours||||||
639925|NCT02369510|Secondary|Incidence of Nausea and Vomiting||up to 3 hours|||Participants|||Count of Participants
639926|NCT02369510|Secondary|Patient Satisfaction|"Patient satisfaction score was elicited upon arrival to the recovery room on a 1-5 Likert scale. Number of participants selecting the highest score of 5 or completely satisfied."|up to 3 hours|||percentage of participants|||Number
639927|NCT02369510|Secondary|Adequacy of Anesthesia|As measured by pinprick sensation and/or patient discomfort as measured by verbal pain score on a scale of 0=no pain to 10=worst imaginable pain, obtained within 3 hours of receiving anesthesia.|up to 3 hrs|||units on a scale||Inter-Quartile Range|Median
639928|NCT02369510|Secondary|Number of Participants With Hypotension|Incidence of hypotension as measured by participants needing vasopressor agents|at 2 minutes and at 25 minutes|||Participants|||Count of Participants
639929|NCT02369510|Secondary|Block Onset|Time to a onset of T4 level of anesthesia or the highest level achieved in 15min|up to 15 min|||minutes||Inter-Quartile Range|Median
639930|NCT02369510|Secondary|Motor Recovery|Time to Bromage 3 motor recovery|up to 4 hours|||minutes||95% Confidence Interval|Median
639931|NCT02369510|Primary|Sensory Recovery|Time to T10 sensory recovery as measured by pinprick sensation|up to 3 hours|||minutes||95% Confidence Interval|Median
639971|NCT02368314|Primary|Frequency of DVT.|Frequency of deep vein thrombosis (DVT) (proximal and/or distal; symptomatic or asymptomatic).|During the treatment period (14 days)|Patient who finished the study as per protocol and had contrast venography results for efficacy evaluation.||participants|||Number
639972|NCT02368093|Primary|Good European League Against Rheumatism (EULAR) Therapeutic Response Rate||6 months|||participants|||Number
639952|NCT02368457|Primary|Bone and/or Tissue Healing as Measured With the Classification of ORN Stages, Area of Bone Exposed (mm2) and Radiological Findings (OPG).|"Clinical healing assessment as measured with the classification of ORN stages, area of bone exposed (mm2) and radiological findings (OPG).
Intraoral bone exposure is measured in mm2."|From baseline to 1, 3, 6, and 9 months of starting treatment|mean of intraoral bone exposure (measured in mm2) from baseline to 1, 3, 6, 9, 12 and 18 months of starting treatment||mm2||Full Range|Mean
639953|NCT02368314|Secondary|Frequency of Other AE SAE||During the treatment period (14 days) and follow-up period (till 60-th day)||||||
639951|NCT02368457|Secondary|Clinical Symptoms Evaluation, Measured Using the LENT-SOMA Scale|"Evaluation of symptoms improvement using the LENT-SOMA scale (Late Effect Normal Tissue Task Force / Subjective, Objective, Management, Analytic scale).
To examine the LENT/SOMA scale prospectively using interviews and questionnaires
Assessments were made from baseline to 1, 3, 6 and 9 months of starting treatments. The acceptability and feasibility of using the scales was examined using compliance in completion of the questionnaires.
Maximum score: 36 Minimum score: 0
Questionnaires have been completed for 24 patients after treatment. Higher values represents worse outcome.
Scale categories:
Subjective: pain, nutritional problems, difficulty in mouth openning. Objective: bone exposure, trismus, Management: analgesic treatment, oral treatment, nutrition. Analytic: radiological findings."|From baseline to 1,3, 6, 9 months of starting treatment|||units on a scale||Full Range|Mean
639954|NCT02368314|Secondary|Frequency of Strokes, Myocardial Infarction, Unstable Angina and Cardiovascular Death||During the treatment period (14 days) and follow-up period (till 60-th day)||||||
639973|NCT02367885|Secondary|GMT of SRH Antibody Titer (Vero Antigen)|GMT of SRH antibody titer (Vero antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.|Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.||titer||95% Confidence Interval|Geometric Mean
639974|NCT02367885|Secondary|GMFI in SRH Antibody Titer (Vero Antigen) From Baseline to 21 Days After Each Vaccination|GMFI from baseline in SRH antibody titer (Vero antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.|Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.||fold increase||95% Confidence Interval|Geometric Mean
639975|NCT02367885|Secondary|Percentage of Participants With Seroconversion in SRH Antibody Titer (Vero Antigen)|Seroconversion rate was measured by SRH antibody titer (Vero antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Seroconversion rate was defined as the percentage of participants achieving a minimal 50% increase from baseline (with a baseline SRH antibody titer of >4 mm^2), or achieving a SRH antibody titer of >=25 mm^2 (with baseline SRH antibody titer of <=4 mm^2) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain). Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.|Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.||percentage of participants||95% Confidence Interval|Number
639976|NCT02367885|Secondary|Percentage of Participants With Seroprotection in SRH Antibody Titer (Vero Antigen) of >= 25 mm^2|Seroprotection rate was measured by SRH antibody titer (Vero Antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Seroprotection rate was defined as the percentage of participants with SRH antibody titer of >=25 mm^2. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.|Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.||percentage of participants||95% Confidence Interval|Number
639977|NCT02367885|Secondary|GMT of HI Antibody Titer (Vero Antigen)|GMT of HI antibody titer (Vero antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.|Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.||titer||95% Confidence Interval|Geometric Mean
639978|NCT02367885|Secondary|GMFI in HI Antibody Titer (Vero Antigen) From Baseline to 21 Days After Each Vaccination|GMFI from baseline in HI antibody titer (Vero antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.|Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.||fold increase||95% Confidence Interval|Geometric Mean
639979|NCT02367885|Secondary|Percentage of Participants With Seroconversion in HI Antibody Titer (Vero Antigen)|Seroconversion rate was measured by HI antibody titer (Vero antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Seroconversion rate was defined as the percentage of participants achieving a minimal 4-fold increase from baseline (with a baseline HI antibody titer of >=10), or achieving a HI antibody titer of >=40 (with baseline HI antibody titer of <10) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain). Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.|Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.||percentage of participants||95% Confidence Interval|Number
639980|NCT02367885|Secondary|Percentage of Participants With Seroprotection in HI Antibody Titer (Vero Antigen) of >=40|Seroprotection rate was measured by HI antibody titer (Vero antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Seroprotection rate was defined as the percentage of participants with HI antibody titer of >=40. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.|Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.||percentage of participants||95% Confidence Interval|Number
639981|NCT02367885|Secondary|GMT of SRH Antibody Titer (Egg-Derived Antigen)|GMT of SRH antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.|Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.||titer||95% Confidence Interval|Geometric Mean
639982|NCT02367885|Secondary|GMFI in SRH Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After Each Vaccination|GMFI from baseline in SRH antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.|Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6 -35 months old group and 3-12 years old group)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.||fold increase||95% Confidence Interval|Geometric Mean
639983|NCT02367885|Secondary|Percentage of Participants With Seroconversion in SRH Antibody Titer (Egg-Derived Antigen)|Seroconversion rate was measured by SRH antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Seroconversion rate was defined as the percentage of participants achieving a minimal 50% increase from baseline (with a baseline SRH antibody titer of >4 mm^2) or achieving a SRH antibody titer of >=25 mm^2 (with baseline SRH antibody titer of <=4 mm^2) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain). Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.|Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.||percentage of participants||95% Confidence Interval|Number
639984|NCT02367885|Secondary|Percentage of Participants With Seroprotection in Single Radial Hemolysis (SRH) Antibody Titer (Egg- Derived Antigen) of >=25 Square Millimeter (mm^2)|Seroprotection rate was measured by SRH antibody titer (egg- derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Seroprotection rate was defined as the percentage of participants with SRH antibody titer of >=25 mm^2. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.|Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.||percentage of participants||95% Confidence Interval|Number
639985|NCT02367885|Secondary|Geometric Mean Titer (GMT) of HI Antibody Titer (Egg-Derived Antigen)|GMT of HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination. Analysis after Vaccination 2 is only applicable for 6-35 Months old group and 3-12 Years old group.|Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)|All participants included in FAS (all participants who received at least 1 dose of study vaccination) who had available data for specified strain at specified post-baseline time points.||titer||95% Confidence Interval|Geometric Mean
639986|NCT02367885|Secondary|GMFI in HI Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After the First Vaccination for 6-35 Months Old Group and 3-12 Years Old Group|GMFI from baseline in HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after first vaccination for two age groups: 6-35 months and 3-12 years.|Day 22 (21 days after Vaccination 1)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time point.||fold increase||95% Confidence Interval|Geometric Mean
639987|NCT02367885|Secondary|Percentage of Participants With Seroconversion in HI Antibody Titer (Egg-Derived Antigen): 21 Days After the First Vaccination for 6-35 Months Old Group and 3-12 Years Old Group|Seroconversion rate was measured by HI antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after the first vaccination for two age groups: 6-35 months and 3-12 years. Seroconversion rate was defined as the percentage of participants achieving a minimal 4-fold increase from baseline (with a baseline HI antibody titer of >=10), or achieving a HI antibody titer of >=40 (with baseline HI antibody titer of <10) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain).|Day 22 (21 days after Vaccination 1)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time point.||percentage of participants||95% Confidence Interval|Number
639988|NCT02367885|Secondary|Percentage of Participants With Seroprotection in HI Antibody Titer (Egg-Derived Antigen) of >= 40: 21 Days After the First Vaccination for 6-35 Months Old Group and 3-12- Years Old Group|Seroprotection rate was measured by HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after first vaccination for two age groups: 6-35 months and 3-12 years. Seroprotection rate was defined as the percentage of participants with HI antibody titer of >=40.|Day 22 (21 days after Vaccination 1)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time point.||percentage of participants||95% Confidence Interval|Number
639989|NCT02367885|Primary|GMFI in HI Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After the Second Vaccination for 6-35 Months Old Group and 3-12 Years Old Group|GMFI from baseline in HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after second vaccination for two age groups: 6-35 months and 3-12 years.|Day 43 (21 days after Vaccination 2)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time point.||fold increase||95% Confidence Interval|Geometric Mean
639990|NCT02367885|Primary|Geometric Mean Fold Increase (GMFI) in HI Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After the Vaccination for 13-19 Years Old Group|GMFI from baseline in HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination for the age group of 13-19 years.|Day 22 (21 days after Vaccination)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time point.||fold increase||95% Confidence Interval|Geometric Mean
640404|NCT02353442|Primary|Humeral Translations at 4weeks (Pre and Post Treatment).|It was assessed in millimeters with 3D system pre and post treatment.|4 weeks: Baseline (pre-treatment), and 4 weeks (post-treatment)|||Millimeters||Standard Error|Mean
639991|NCT02367885|Primary|Percentage of Participants With Seroconversion in HI Antibody Titer (Egg-Derived Antigen): 21 Days After the Second Vaccination for 6-35 Months Old Group and 3-12 Years Old Group|Seroconversion rate was measured by HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after second vaccination for two age groups: 6-35 months and 3-12 years. Seroconversion rate was defined as the percentage of participants achieving a minimal 4-fold increase from baseline (with a baseline HI antibody titer of >=10), or achieving a HI antibody titer of >=40 (with a baseline HI antibody titer of <10) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain).|Day 43 (21 days after Vaccination 2)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time point.||percentage of participants||95% Confidence Interval|Number
639992|NCT02367885|Primary|Percentage of Participants With Seroconversion in Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen): 21 Days After the Vaccination for 13-19 Years Old Group|Seroconversion rate was measured by HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination for the age group of 13-19 years. Seroconversion rate was defined as the percentage of participants achieving a minimal 4-fold increase from baseline (with a baseline HI antibody titer of >=10), or achieving a HI antibody titer of >=40 (with a baseline HI antibody titer of <10) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain).|Day 22 (21 days after Vaccination)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time point.||percentage of participants||95% Confidence Interval|Number
639993|NCT02367885|Primary|Percentage of Participants With Seroprotection in HI Antibody Titer (Egg-Derived Antigen) of >=40: 21 Days After the Second Vaccination for 6-35 Months Old Group and 3-12 Years Old Group|Seroprotection rate was measured by HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after second vaccination for two age groups: 6-35 months and 3-12 years. Seroprotection rate was defined as the percentage of participants with HI antibody titer of >=40.|Day 43 (21 days after Vaccination 2)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time point.||percentage of participants||95% Confidence Interval|Number
639994|NCT02367885|Primary|Percentage of Participants With Seroprotection in Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen) of >=40: 21 Days After the Vaccination for 13-19 Years Old Group|Seroprotection rate was measured by HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination for the age group of 13-19 years. Seroprotection rate was defined as the percentage of participants with HI antibody titer of >=40.|Day 22 (21 days after Vaccination)|All participants included in the full analysis set (FAS) (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time point.||percentage of participants||95% Confidence Interval|Number
639995|NCT02367885|Primary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event. AEs included both SAE and non-SAE.|Up to 21 days after any vaccination|Safety analysis set included all participants who received at least 1 dose of study vaccination.||participants|||Number
639996|NCT02367885|Primary|Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 3-12 Years Old Group and 13-19 Years Old Group|Local reactions and systemic events were recorded using a diary. Number of participants with local reactions (Injection site pain, Injection site redness, Injection site swelling, Injection site induration, Injection site tenderness, Injection site ecchymosis) and systemic events (Pyrexia, malaise, chills, fatigue, headache, sweaty, myalgia, nausea, vomiting) were reported. Participants may be represented in more than 1 category.|Up to 21 days after any vaccination|Safety analysis set included all participants who received at least 1 dose of study vaccination.||participants|||Number
639997|NCT02367885|Primary|Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 6-35 Months Old Group|Local reactions and systemic events were recorded using a diary. Number of participants with local reactions (Injection site tenderness, Injection site ecchymosis, Irritability postvaccinal) and systemic events (Pyrexia, sweaty, vomiting, crying abnormal, inappetence, somnolence, sleeplessness) were reported. Participants may be represented in more than 1 category.|Up to 21 days after any vaccination|Safety analysis set included all participants who received at least 1 dose of study vaccination.||participants|||Number
639998|NCT02367872|Secondary|Number of Participants With TEAE Related to Laboratory Tests (Alanine Aminotransferase Increased)||Baseline up to Day 8 of each Cohort|The safety analysis set included all participants who were treated with at least 1 dose of study drug.||participants|||Number
639999|NCT02367872|Secondary|Number of Participants With TEAE Related to 12-lead Electrocardiograms (ECG)||Baseline up to Day 8 of each Cohort|The safety analysis set included all participants who were treated with at least 1 dose of study drug.||participants|||Number
640000|NCT02367872|Secondary|Number of Participants With TEAE Related to Body Weight||Baseline up to Day 8 of each Cohort|The safety analysis set included all participants who were treated with at least 1 dose of study drug.||participants|||Number
640001|NCT02367872|Secondary|Number of Participants With TEAE Related to Vital Signs (Blood Pressure Decreased)||Baseline up to Day 8 of each Cohort|The safety analysis set included all participants who were treated with at least 1 dose of study drug.||participants|||Number
640002|NCT02367872|Secondary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)||Baseline up to Day 8 of each Cohort|The safety analysis set included all participants who were treated with at least 1 dose of study drug.||participants|||Number
640003|NCT02367872|Primary|Excretion Ratio of TAK-272F in Dialysate in Cohort 5R|Excretion ratio (% of dose) of TAK-272F in dialysis fluid was calculated for each participant.|Day 1: Pre-dose and at multiple time points (up to 6 hours) post-dose|The dialysate PK set included all participants treated with the study drug who had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for dialysate PK.||percentage of dose||Standard Deviation|Mean
640004|NCT02367872|Primary|Plasma Protein Binding Rate of TAK-272F in Cohorts 1R, 2R, 3R, 4R, 5R, 1H, 2H and 3H|Plasma protein binding rate was the percentage of unbound fraction of TAK-272F in plasma protein.|Baseline|The plasma PK set included all participants treated with the study drug who had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for plasma PK.||% of unbound fraction of TAK-272F||Standard Deviation|Mean
640005|NCT02367872|Primary|Cumulative Urinary Excretion Ratio of TAK-272F and Its Metabolite M-I From 0 to 72 Hours Post-dose in Cohorts 1R, 2R, 3R, 4R, 1H, 2H and 3H|Urinary excretion ratio (percentage [%] of dose) of TAK-272 and its metabolite M-I in urine was calculated for each participant.|Day 1: Pre-dose and at multiple time points (up to 72 hours) post-dose|The urine PK analysis population where urinary excretion data on Day 1 was available. The urine PK set included all participants treated with the study drug who had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for urine PK.||percentage of dose||Standard Deviation|Mean
640006|NCT02367872|Primary|CLu/F: Apparent Clearance for Unbound Drug After Extravascular Administration for TAK-272F|CLu/F is the apparent clearance for unbound drug after extravascular administration of TAK-272.|Day 1: Pre-dose and at multiple time points (up to 120 hours) post-dose|The plasma PK set included all participants treated with the study drug who had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for plasma PK.||L/hr||Standard Deviation|Mean
640007|NCT02367872|Primary|Apparent Clearance (CL/F) for TAK-272F||Day 1: Pre-dose and at multiple time points (up to 120 hours) post-dose|The plasma PK set included all participants treated with the study drug who had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for plasma PK.||liter per hour (L/hr)||Standard Deviation|Mean
640008|NCT02367872|Primary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-272F and Its Metabolite M-I||Day 1: Pre-dose and at multiple time points (up to 120 hours) post-dose|The plasma PK set included all participants treated with the study drug who had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for plasma PK.||hour||Full Range|Median
640009|NCT02367872|Primary|AUC∞,u: Area Under the Unbound Plasma Concentration-time Curve From Time 0 to Infinity for TAK-272F|AUC∞,u is the area under the concentration-time curve of the unbound drug in plasma over the time interval from 0 to infinity of TAK-272.|Day 1: Pre-dose and at multiple time points (up to 120 hours) post-dose|The plasma PK set included all participants treated with the study drug who had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for plasma PK.||ng*hr/mL||Standard Deviation|Geometric Mean
640010|NCT02367872|Primary|Cmax,u: Maximum Unbound Plasma Concentration for TAK-272F|Cmax,u is the peak unbound plasma concentration of a drug after administration, obtained directly from the unbound plasma concentration-time curve.|Day 1: Pre-dose and at multiple time points (up to 120 hours) post-dose|The plasma PK set included all participants treated with the study drug who had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for plasma PK.||ng/mL||Standard Deviation|Geometric Mean
640011|NCT02367872|Primary|AUClast,u: Area Under the Unbound Plasma Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration for TAK-272F|AUClast,u is the area under the concentration-time curve of the unbound drug in plasma over the time interval from 0 to time of last quantifiable post-dose of TAK-272.|Day 1: Pre-dose and at multiple time points (up to 120 hours) post-dose|The plasma PK set included all participants treated with the study drug who had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for plasma PK.||ng*hr/mL||Standard Deviation|Geometric Mean
640012|NCT02367872|Primary|AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-272F and Its Metabolite M-I||Day 1: Pre-dose and at multiple time points (up to 120 hours) post-dose|The plasma PK set included all participants treated with the study drug who had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for plasma PK.||ng*hr/mL||Standard Deviation|Geometric Mean
640013|NCT02367872|Primary|Cmax: Maximum Observed Plasma Concentration for TAK-272F and Its Metabolite M-I||Day 1: Pre-dose and at multiple time points (up to 120 hours) post-dose|The plasma PK set included all participants treated with the study drug who had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for plasma PK.||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
640014|NCT02367872|Primary|AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Free Form of TAK-272 (TAK-272F) and Its Metabolite M-I||Day 1: Pre-dose and at multiple time points (up to 120 hours) post-dose|The plasma PK set included all participants treated with the study drug who had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for plasma PK.||nanogram*hour per milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
640015|NCT02367391|Secondary|Total Score on the Positive Smoking Cessation Activities Measure|Total score for 6 items (scored 0-3). Total score range 0-18.|12 weeks|This data is presented for only participants who showed to Visit 2.||activities||Standard Deviation|Mean
640016|NCT02367391|Secondary|Time (in Days) to Relapse After the Target Quit Day||12 weeks|||days||Standard Deviation|Mean
640017|NCT02367391|Secondary|Continuous Lapse-free Tobacco Abstinence From 4 Weeks to 12 Weeks, Biochemically Validated at Visit 2 and Visit 3.||12 weeks|||Participants|||Count of Participants
640018|NCT02367391|Primary|Number of Active Smoking Cessation Activities Used|Number of activities completed out of 6|12 weeks|This data is presented for only participants who showed to Visit 2.||activities||Standard Deviation|Mean
640019|NCT02367391|Primary|Number of Days of Varenicline Use||12 weeks|||days||Standard Deviation|Mean
640020|NCT02367391|Primary|Sustained Abstinence at the 12-week Follow up||12 weeks|||Participants|||Count of Participants
640021|NCT02367391|Primary|Point Prevalence of 7-day Tobacco Abstinence Biochemically Validated by Exhaled CO < 10ppm at Visit 3 (12 Weeks After Target Quit Day)||12 weeks|||Participants|||Count of Participants
640022|NCT02367170|Secondary|A Change in the Urinary Excretion Markers of Muscle Catabolism From Baseline|Investigators will determine the effects of IMST on urinary excretion markers of muscle catabolism in patients with CCI. Investigators hypothesize that exercise will decrease urinary markers of catabolism compared to the SHAM condition.|Day 1, Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 15, Day 17, Day 19, Day 21||||||
640023|NCT02367170|Secondary|A Change in the Results of the Biomarkers of Inflammation From Baseline|Investigators will determine the effects of IMST on biomarkers of inflammation in patients with CCI. Investigators hypothesize that exercise will decrease markers of inflammation compared to the SHAM condition.|Day 1, Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 15, Day 17, Day 19, Day 21||||||
640024|NCT02367170|Primary|A Change in Diaphragm Strength From Baseline as an Effect of Inspiratory Muscle Strength Training (IMST) Intervention and Sham Patients|In this randomized, interventional study, 24 CCI patients will be assigned to either a sham group or to receive IMST for up to 28 days. Evaluation of diaphragm/inspiratory muscle strength and muscle thickness will be made with three techniques: 1) non-volitional magnetic stimulation of the phrenic nerves, 2) noninvasive measurement of diaphragm thickness with ultrasound and 3) the standard, clinical method of measuring maximal inspiratory pressure (MIP). Investigators hypothesize that IMST will lead to improvements in all three measures. This study will provide information about possible effective respiratory muscle rehabilitation techniques that are likely to lead to reduced time patients will require mechanical ventilation and improved MIP and weaning outcome in long-term, failure to wean patients|Day 1, Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 14, Day 15, Day 17, Day 19, Day 21, Day 23, Day 25, Day 28|Unable to recruit sufficient number of patients.|||||
640025|NCT02367066|Secondary|Apparent Oral Plasma AZD1981 at Steady-State, CL_ss/F||Days 2,3,8,9|One value per subject and method (MMTT/GGI). Value calculated on days 2 and 3 if subject in sequence AZD1981-Placebo or on days 8 and 9 if subject in sequence Placebo-AZD1981.||L/h||Standard Deviation|Mean
640026|NCT02367066|Secondary|Plasma AZD1981 AUC(0-24h)||Days 2,3,8,9|One value per subject and method (MMTT/GGI). Value calculated on days 2 and 3 if subject in sequence AZD1981-Placebo or on days 8 and 9 if subject in sequence Placebo-AZD1981.||h*nmol/L||Geometric Coefficient of Variation|Geometric Mean
640027|NCT02367066|Secondary|Plasma AZD1981 AUC(0-12h)||Days 2,3,8,9|One value per subject and method (MMTT/GGI). Value calculated on days 2 and 3 if subject in sequence AZD1981-Placebo or on days 8 and 9 if subject in sequence Placebo-AZD1981.||h*nmol/L||Geometric Coefficient of Variation|Geometric Mean
640028|NCT02367066|Secondary|Plasma AZD1981 AUC(0-4h)||Days 2,3,8,9|One value per subject and method (MMTT/GGI). Value calculated on days 2 and 3 if subject in sequence AZD1981-Placebo or on days 8 and 9 if subject in sequence Placebo-AZD1981.||h*nmol/L||Geometric Coefficient of Variation|Geometric Mean
640029|NCT02367066|Secondary|Change From Baseline to Endpoint GGI AUC(0-24h) for Plasma Glucose||Day -1 to Day 3 and Day 6 to Day 9|One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.||h*mmol/L||Standard Deviation|Geometric Mean
640030|NCT02367066|Secondary|Change From Baseline to Endpoint GGI AUC(0-1h) for Plasma C-Peptide||Day -1 to Day 3 and Day 6 to Day 9|One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.||h*pmol/L||Standard Deviation|Geometric Mean
640031|NCT02367066|Secondary|Plasma Paracetamol AUC(0-t)||Days 3,9|One value per subject and treatment. AZD1981 value calculated at Day 3 if subject in sequence AZD1981-Placebo or at Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day 3 if subject in sequence Placebo-AZD1981 or at Day 9 if subject in sequence AZD1981-Placebo.||h*ng/ML||Geometric Coefficient of Variation|Geometric Mean
640032|NCT02367066|Secondary|Time of Maximum Plasma Paracetamol Concentration, t_max||Days 3,9|One value per subject and treatment. AZD1981 value calculated at Day 3 if subject in sequence AZD1981-Placebo or at Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day 3 if subject in sequence Placebo-AZD1981 or at Day 9 if subject in sequence AZD1981-Placebo.||h||Full Range|Median
640033|NCT02367066|Secondary|Plasma Paracetamol Maximum Concentration, C_max||Days 3,9|One value per subject and treatment. AZD1981 value calculated at Day 3 if subject in sequence AZD1981-Placebo or at Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day 3 if subject in sequence Placebo-AZD1981 or at Day 9 if subject in sequence AZD1981-Placebo.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
640034|NCT02367066|Secondary|Plasma AZD1981 AUC(1-2h)||Days 2,3,8,9|One value per subject and method (MMTT/GGI). Value calculated on days 2 and 3 if subject in sequence AZD1981-Placebo or on days 8 and 9 if subject in sequence Placebo-AZD1981.||h*nmol/L||Geometric Coefficient of Variation|Geometric Mean
640035|NCT02367066|Secondary|Minimum Plasma AZD1981 Concentration at Steady-State, C_ss,Min||Days 2,3,8,9|One value per subject and method (MMTT/GGI). Value calculated on days 2 and 3 if subject in sequence AZD1981-Placebo or on days 8 and 9 if subject in sequence Placebo-AZD1981.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
640036|NCT02367066|Secondary|Plasma AZD1981 AUC(0-2h)||Days 2,3,8,9|One value per subject and method (MMTT/GGI). Value calculated on days 2 and 3 if subject in sequence AZD1981-Placebo or on days 8 and 9 if subject in sequence Placebo-AZD1981.||h*nmol/L||Geometric Coefficient of Variation|Geometric Mean
640037|NCT02367066|Secondary|Plasma AZD1981 AUC(0-1h)||Days 2,3,8,9|One value per subject and method (MMTT/GGI). Value calculated on days 2 and 3 if subject in sequence AZD1981-Placebo or on days 8 and 9 if subject in sequence Placebo-AZD1981.||h*nmol/L||Geometric Coefficient of Variation|Geometric Mean
640038|NCT02367066|Secondary|Time of Maximum Plasma AZD1081 Concentration, t_ss,Max||Days 2,3,8,9|One value per subject and method (MMTT/GGI). Value calculated on days 2 and 3 if subject in sequence AZD1981-Placebo or on days 8 and 9 if subject in sequence Placebo-AZD1981.||h||Full Range|Median
640039|NCT02367066|Secondary|Maximum Plasma AZD1981 Concentration at Steady-State, C_ss,Max||Days 2,3,8,9|One value per subject and method (MMTT/GGI). Value calculated on days 2 and 3 if subject in sequence AZD1981-Placebo or on days 8 and 9 if subject in sequence Placebo-AZD1981.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
664254|NCT01788215|Secondary|Serum Hormone Binding Globulin (SHBG)||week 12|||nmol/L||Standard Deviation|Mean
640040|NCT02367066|Secondary|Fasting Insulin at Endpoint||Day 3 and Day 9|One value per subject and treatment. AZD1981 value calculated at Day 3 if subject in sequence AZD1981-Placebo or at Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day 3 if subject in sequence Placebo-AZD1981 or at Day 9 if subject in sequence AZD1981-Placebo.||UIU/ML||Standard Error|Least Squares Mean
640041|NCT02367066|Secondary|Change From Baseline to Endpoint Fasting Beta-cell Responsiveness||Day -1 to Day 3 and Day 6 to Day 9|One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.||10^-9*(L/kg)*min||Standard Error|Least Squares Mean
640042|NCT02367066|Secondary|Change From Baseline to Endpoint GGI AUC(1-2h) for Plasma Glucagon||Day -1 to Day 3 and Day 6 to Day 9|One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.||h*mmol/L||Standard Deviation|Geometric Mean
640043|NCT02367066|Secondary|Change From Baseline to Endpoint GGI AUC(0-1h) for Plasma Glucagon||Day -1 to Day 3 and Day 6 to Day 9|One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.||h*mmol/L||Standard Deviation|Geometric Mean
640044|NCT02367066|Secondary|Change From Baseline to Endpoint GGI AUC(1-2h) for Plasma Insulin||Day -1 to Day 3 and Day 6 to Day 9|One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.||h*mU/L||Standard Deviation|Geometric Mean
640045|NCT02367066|Secondary|Change From Baseline to Endpoint GGI AUC(0-1h) for Plasma Insulin||Day -1 to Day 3 and Day 6 to Day 9|One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.||h*mU/L||Standard Deviation|Geometric Mean
640046|NCT02367066|Secondary|Change From Baseline to Endpoint MMTT AUC(0-4h) for Plasma C-Peptide||Day -1 to Day 3 and Day 6 to Day 9|One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.||h*pmol/L||Standard Deviation|Geometric Mean
640047|NCT02367066|Secondary|Change From Baseline MMTT AUC(0-4h) for Plasma Glucagon||Day -1 to Day 3 and Day 6 to Day 9|One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.||h*pmol/L||Standard Deviation|Geometric Mean
640048|NCT02367066|Secondary|Change From Baseline to Endpoint MMTT AUC(0-4h) for Plasma Insulin||Day -1 to Day 3 and Day 6 to Day 9|One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.||h*mU/L||Standard Deviation|Geometric Mean
640049|NCT02367066|Primary|Change From Baseline to Endpoint GGI AUC(1-2h) for Plasma C-Peptide|GGI=Glucose and GLP1 infusion AUC=Area Under Curve|Day -1 to Day 3 and Day 6 to Day 9|One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.||h*pmol/L||Standard Deviation|Geometric Mean
640050|NCT02367066|Primary|Change From Baseline to Endpoint MMTT C_max for Plasma Glucose||Day -1 to Day 3 and Day 6 to Day 9|One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.||nmol/L||Standard Deviation|Geometric Mean
640051|NCT02367066|Primary|Change From Baseline to Endpoint MMTT AUC(0-4h) for Plasma Glucose|MMTT=Mixed Meal Tolerance Test AUC=Area Under Curve|Day -1 to Day 3 and Day 6 to Day 9|One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.||h*nmol/L||Standard Deviation|Geometric Mean
640052|NCT02366936|Primary|Number of Infants That Developed Dolichocephaly by the End of the Study|dolichocephaly for this study is considered a cranial Index <76% at 34 weeks post menstrual age (PMA)|34 weeks gestational age|||participants|||Number
640053|NCT02366936|Primary|Cranial Index (CI)|"CI was determined by calculating the ratio of the biparietal diameter (BiPD) over the occipitofrontal diameter (OFD). The BiPD is defined as the widest transverse diameter of the head. BiPD was measured from the most prominent lateral point on each side of the skull in the area of parietal and temporal bones. The OFD is defined as the diameter of the head from the most prominent midline point of the frontal bone (glabella) to the occipital protuberance. While various reported ranges exist for cranial molding norms, dolichocephaly was defined as a CI of <76%. The normative CI range is 76-85% for prone and supine sleeping infants.
CI = BPD/OFD x 100"|34 weeks gestational age|||cranial index||Full Range|Median
640054|NCT02366923|Primary|Moisture Retention (Median) of Stenfilcon A and Delefilcon A|Comparison between lens types up to and at 12 hours of wear of moisture retention by measuring relative percentage dehydration (RPD).|12 Hours of Wear|There were outliers across four participants in five lenses due to the fact that the weight of the worn lens after 12 hours was greater than the baseline weight of the lens from the blister pack. The sample size for statistical analysis is reduced to 18 pairs.||percentage of dehyrdation||Full Range|Median
640055|NCT02366923|Primary|Moisture Retention (Mean) of Stenfilcon A and Delefilcon A|Comparison between lens types up to and at 12 hours of wear of moisture retention by measuring relative percentage dehydration (RPD).|12 Hours of Wear|There were outliers across four participants in five lenses due to the fact that the weight of the worn lens after 12 hours was greater than the baseline weight of the lens from the blister pack. The sample size for statistical analysis is reduced to 18 pairs.||percentage of dehyrdation||Standard Deviation|Mean
640056|NCT02366923|Primary|Absolute Change in Water Content (Median) of Stenfilcon A and Delefilcon A|Comparison between lens types up to and at 12 hours of wear for the absolute change in water content (WC).|12 Hours of Wear|There were outliers across four participants in five lenses due to the fact that the weight of the worn lens after 12 hours was greater than the baseline weight of the lens from the blister pack. The sample size for statistical analysis is reduced to 18 pairs.||absolute WC change||Full Range|Median
640057|NCT02366923|Secondary|Subjective Comfort of Stenfilcon A and Delefilcon A|Subjective ratings for stenfilcon A and delefilcon A assessed at every hour up to 12 hours. (Scale 0-100, 0=very poor 100=excellent)|Up to 12 Hours of Wear|||units on a scale||Standard Deviation|Mean
640058|NCT02366923|Primary|Absolute Change in Water Content (Mean) of Stenfilcon A and Delefilcon A|Comparison between lens types up to and at 12 hours of wear for the absolute change in water content (WC).|12 Hours of Wear|There were outliers across four participants in five lenses due to the fact that the weight of the worn lens after 12 hours was greater than the baseline weight of the lens from the blister pack. The sample size for statistical analysis is reduced to 18 pairs.||absolute WC change||Standard Deviation|Mean
640059|NCT02366910|Primary|Moisture Retention (Median) of Omafilcon A and Delefilcon A|Comparison between lens types up to and at 12 hours of wear of moisture retention by measuring relative percentage dehydration (RPD).|12 Hours|Because of the outliers across three participants, the sample size for statistical analysis is reduced to 18 pairs.||percentage of dehyrdation||Full Range|Median
640060|NCT02366910|Primary|Moisture Retention (Mean) of Omafilcon A and Delefilcon A|Comparison between lens types up to and at 12 hours of wear of moisture retention by measuring relative percentage dehydration (RPD).|12 Hours|Because of the outliers across three participants, the sample size for statistical analysis is reduced to 18 pairs.||percentage of dehyrdation||Standard Deviation|Mean
640061|NCT02366910|Primary|Absolute Change in Water Content (Median) of Omafilcon A and Delefilcon A|Comparison between lens types up to and at 12 hours of wear for the absolute change in water content (WC).|12 Hours of Wear|Because of the outliers across three participants, the sample size for statistical analysis is reduced to 18 pairs.||absolute WC change||Full Range|Median
640062|NCT02366910|Primary|Absolute Change in Water Content (Mean) of Omafilcon A and Delefilcon A|Comparison between lens types up to and at 12 hours of wear for the absolute change in water content (WC).|12 Hours of Wear|Because of the outliers across three participants, the sample size for statistical analysis is reduced to 18 pairs.||absolute WC change||Standard Deviation|Mean
640063|NCT02366767|Secondary|Efficacy of Hybrid Closed-loop System in Comparison With Control|As measured by overall mean sensor glucose percent time in range 70-180 mg/dL.|6 days|Including only sensor data where the daily median ARD <15%.||Percent time||Standard Error|Mean
640064|NCT02366767|Secondary|Feasibility of Using the Automatic Closed Loop Delivery System in Adolescents and Adults With Type 1 Diabetes|"As measured by the system initiating and operating properly for at least 75% of the time for 75% of subjects.
As measure by the completion of study enrollment procedures and education on system use within 2 hours for 75% of the subjects."|6 days|||participants|||Number
640065|NCT02366767|Primary|Safety of Automatic Closed Loop Insulin Delivery System in Adolescents and Adults With Type 1 Diabetes|"As measured by the number of events of plasma glucose values ≤ 50 mg/dL OR frequency of system alerts preceding a plasma glucose value of ≤ 50 mg/dL in all subjects
As measured by the number of events of system alerts of plasma glucose values >300 mg/dL lasting for more than one hour in all subjects.
As measured by number of events of serum ketones >3 mmol/L in all subjects
As measured by the number of events meeting the criteria for severe hypoglycemia, defined as hypoglycemic seizure, loss of consciousness or coma or an event requiring administration of glucagon or IV glucose in all subjects"|6 days|10 subjects who completed study||Events|||Number
640066|NCT02366689|Primary|Gingivitis Scores|Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)|6 months|||units on a scale||Standard Deviation|Mean
640067|NCT02366689|Primary|Gingivitis Scores|Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)|3 months|||units on a scale||Standard Deviation|Mean
640068|NCT02366689|Primary|Gingivitis Scores|Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)|Baseline|||units on a scale||Standard Deviation|Mean
640069|NCT02366689|Primary|Dental Plaque Scores|Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|6 months|||units on a scale||Standard Deviation|Mean
640070|NCT02366689|Primary|Dental Plaque Scores|Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|3 months|||units on a scale||Standard Deviation|Mean
640084|NCT02365688|Primary|Dynamic Hemodynamic Response to Fluid Resuscitation|Physiological parameters compared before and after fluid bolus for fluid resuscitation.|Up to 6 hours but not to exceed duration of surgical procedure|Reference devices were in disagreement so the algorithm could not be verified|||||
640071|NCT02366689|Primary|Dental Plaque Scores|Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|Baseline|||units on a scale||Standard Deviation|Mean
640072|NCT02366637|Other Pre-specified|Number of Participants With Laboratory Abnormalities|The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell [RBC] count, RBC morphology, platelet count, white blood cell [WBC] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen [BUN], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, direct and indirect bilirubin, gamma-glutamyl transpeptidase [GGT], alkaline phosphatase, uric acid, albumin, total protein, high sensitivity C-reactive protein [CRP]); urinalysis (specific gravity, pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, microscopy [only if urine dipstick was positive for blood or protein]).|Baseline up to Week 4|The mITT analysis set included all randomized participants who received at least 1 dose of study drug.||participants|||Number
640073|NCT02366637|Other Pre-specified|Change From Baseline in Pulse Rate|Pulse rate was evaluated in the supine position.|Baseline, Day 7 (Week 1), Day 21 (Week 3), Day 29 (Week 4), Day 49 (follow-up)|The mITT analysis set included all randomized participants who received at least 1 dose of study drug; n=number of participants analyzed in respective arms for category.||beats per minute (bpm)||Standard Deviation|Mean
640074|NCT02366637|Other Pre-specified|Change From Baseline in Systolic and Diastolic Blood Pressure|Systolic blood pressure (SBP) and diastolic pressure (DBP) were evaluated in the supine position.|Baseline, Day 7 (Week 1), Day 21 (Week 3), Day 29 (Week 4), Day 49 (follow-up)|The mITT analysis set included all randomized participants who received at least 1 dose of study drug; n=number of participants analyzed in respective arms for category.||millimeters of mercury (mmHg)||Standard Deviation|Mean
640075|NCT02366637|Other Pre-specified|Number of Participants With Clinically Significant Treatment Emergent Electrocardiogram (ECG) Findings|Clinically significant ECG findings include: PR interval >=300 milliseconds (msec) or >=25% increase when baseline is >200 msec and >=50% increase when baseline is less than or equal to 200 msec; QRS interval >=200 msec or >=25/50% increase from baseline; QT interval >=500 msec; corrected QT interval using Fridericia's formula (QTcF) >=450 msec or >=30 msec increase.|Baseline up to Day 29 (Week 4)|The mITT analysis set included all randomized participants who received at least 1 dose of study drug.||participants|||Number
640076|NCT02366637|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Day 29 that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.|Baseline up to Day 29 (Week 4)|The mITT analysis set included all randomized participants who received at least 1 dose of study drug.||participants|||Number
640077|NCT02366637|Secondary|Trough Plasma Concentration (Ctrough) of PF-03715455|Ctrough is the concentration prior to study drug administration.|Pre-dose on Day 7 and Day 21; post-dose on Day 7 (10 minutes and 1 hour post-dose) and Day 29|As PK was not a primary objective of the study, only sparse PK sampling was performed to allow for a population PK analysis. As the study was prematurely terminated, there were too few subjects to perform this analysis. Therefore, the PK was not analyzed.|||||
640078|NCT02366637|Secondary|Maximum Observed Plasma Concentrations (Cmax) of PF-03715455||Pre-dose on Day 7 and Day 21; post-dose on Day 7 (10 minutes and 1 hour post-dose) and Day 29|As pharmacokinetics (PK) was not a primary objective of the study, only sparse PK sampling was performed to allow for a population PK analysis. As the study was prematurely terminated, there were too few subjects to perform this analysis. Therefore, the PK was not analyzed.|||||
640079|NCT02366637|Secondary|Change From Baseline in Trough FEV1 and Forced Vital Capacity (FVC) Over 4 Weeks|FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Change over 4 weeks is presented.|Baseline, Week 1 to Week 4|The mITT analysis set included all randomized participants who received at least 1 dose of study drug; n=number of participants analyzed in respective arms for category.||liters||Standard Deviation|Mean
640080|NCT02366637|Secondary|Change From Baseline in Trough FEV1 and Forced Vital Capacity (FVC) at Weeks 1, 3, and 4|FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FEV1 Baseline and Change at Week 4 are already reported under Primary Outcome Measure 1.|Baseline, Day 7 (Week 1), Day 21 (Week 3), Day 29 (Week 4)|The mITT analysis set included all randomized participants who received at least 1 dose of study drug; n=number of participants analyzed in respective arms for category.||liters||Standard Deviation|Mean
640081|NCT02366637|Secondary|Change From Baseline in Sputum Cell Counts Over 4 Weeks|Sputum cell counts included total neutrophils counts and differential (percent [%]), total cell count, total macrophage count and differential (%). Change over 4 weeks was to be presented.|Baseline, Week 1 to Week 4|It was not meaningful to summarize sputum cell counts as there were too few participants in the sputum sub-study and, of those, too few adequate sputum specimens to be meaningfully summarized.|||||
640082|NCT02366637|Primary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 4|FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Trough FEV1 was obtained from spirometry, performed before study treatment administration.|Baseline (Day 1), Day 29 (Week 4)|The modified intent-to-treat (mITT) analysis set included all randomized participants who received at least 1 dose of study drug; n=number of participants analyzed in respective arms for category.||liters||Standard Deviation|Mean
640083|NCT02366338|Primary|Number of Patients With at Least One Inappropriate MAI Criterion|Appropriateness of oral anticoagulants was evaluated by adapted versions of the MAI|1 day|||participants|||Number
640085|NCT02365298|Primary|Quantity of Cytokines and Albumin in Tear Fluid|Measured cytokines: IL-1β, IL-2, IL-6, IL-8, IL-10, IL-12, IL-13, and TNF-alpha. Measurement will be taken after the subject has worn the lenses for a full seven hours. During the 2nd period subjects continued wearing the current lens that they were randomized to for an additional 6 weeks of wear.|12 wks after baseline|All subjects that completed all study visits without a major protocol deviation. All 12 subjects completed the study, however in some subjects the concentration of cytokine levels were below detectable limits in the tear film sample and could not be analyzed.||(pg/ml)||Standard Deviation|Mean
640086|NCT02365298|Primary|Quantity of Cytokines and Albumin in Tear Fluid|Measured cytokines: IL-1β, IL-2, IL-6, IL-8, IL-10, IL-12, IL-13, and TNF-alpha. Measurement will be taken after the subject has worn the lenses for a full seven hours. During the 2nd period subjects continued wearing the current lens that they were randomized to for an additional 6 weeks of wear.|6 wks after baseline|All subjects that completed all study visits without a major protocol deviation. All 12 subjects completed the study, however in some subjects the concentration of cytokine levels were below detectable limits in the tear film sample and could not be analyzed.||(pg/ml)||Standard Deviation|Mean
640087|NCT02365298|Primary|Quantity of Cytokines and Albumin in Tear Fluid|Measured cytokines: IL-1β, IL-2, IL-6, IL-8, IL-10, IL-12, IL-13, and TNF-alpha Measurement will be taken after the subject has worn the lenses for a full seven hours.|2 wks after baseline|Subjects that completed all study visits without a major protocol deviation. All 24 subjects completed the study, however in some subjects the concentration of cytokine levels were below detectable limits in the tear film sample and could not be analyzed.||(pg/ml)||Standard Deviation|Mean
640088|NCT02365298|Primary|Total Protein and Lysosome Deposits|Measurement will be taken after the subject has worn the lenses for a full seven hours|12 wks after baseline|All subjects that completed all study visits without a major protocol deviation.During the 2nd period subjects continued wearing the current lens that they were randomized to for an additional 6 weeks of wear.||(ug/lens)||Standard Deviation|Mean
640089|NCT02365298|Primary|Total Protein and Total Lysosome Deposits|Measurement will be taken after the subject has worn the lenses for a full seven hours|6 wks after baseline|Subjects that completed all study visits without a major protocol deviation. During the 2nd period subjects continued wearing the current lens that they were randomized to for an additional 6 weeks of wear.||(ug/lens)||Standard Deviation|Mean
640090|NCT02365298|Primary|Total Protein and Total Lysosome Deposits|Measurement will be taken after the subject has worn the lenses for a full seven hours|2 wks after baseline|All subjects that completed all study visits without a major protocol deviation.||(ug/lens)||Standard Deviation|Mean
640091|NCT02364778|Secondary|Diameter Stenosis (DS)|Three-Dimensional Quantitative Coronary Angiography (3D-QCA) Analysis of Bifurcation Lesions Before (PRE) and After (POST) Provisional Stenting. Side Branch Ostium Diameter Stenosis (DS).|day 1|||percentage of 100||Standard Error|Mean
640092|NCT02364778|Secondary|SB Ostial Involvement|Optical coherence tomography - a high resolution intravascular imaging technique to assess side branch ostial involvement. Side branch area will be measured by QAngio OCT software (Medis). Three-Dimensional Quantitative Coronary Angiography (3D-QCA) Analysis of Bifurcation Lesions Before (PRE) and After (POST) Provisional Stenting. Minimal lumen diameter (MLD)|day 1|||mm||Standard Error|Mean
640093|NCT02364778|Secondary|SB Angle|Optical coherence tomography - a high resolution intravascular imaging technique to assess side branch (SB) angle. Side branch angle will be measured by QAngio XA 3D software (Medis). Three-Dimensional Quantitative Coronary Angiography (3D-QCA) Analysis of Bifurcation Lesions Before (PRE) and After (POST) Provisional Stenting. Bifurcation angles (BA)|day 1|||degree||Standard Error|Mean
640094|NCT02364778|Primary|MLD SB Diameter|Optical coherence tomography (OCT) - a high resolution intravascular imaging technique to assess side branch size. Side branch diameter will be measured by QAngio OCT software from Medis. Three-Dimensional Quantitative Coronary Angiography (3D-QCA) Analysis of Bifurcation Lesions Before (PRE) and After (POST) Provisional Stenting. Main vessel minimal lumen diameter (MLD)|day 1|||mm||Standard Error|Mean
640095|NCT02364700|Secondary|Stroke Impact Scale --Hand Sub Scale (SIS-H)|"The Stroke Impact Scale is a stroke-specific questionnaire evaluating quality of life in stroke survivors over eight domains. Each domain is scored independently on an ordinal scale ranging from 0 (minimum) bto a maximum of 5. Only the Hand sub-score was used in this study. Scores for each domain are transformed and range from 0-100.
Formula for scoring domains:
Transformed Scale = [(Actual raw score - lowest possible raw score) / Possible raw score] * 100"|baseline to 6 weeks (discharge)|||units on a scale||Standard Deviation|Mean
640096|NCT02364700|Secondary|Hand Dynamometry|A dynamometer measures grip strength in kilograms|baseline to 6 weeks (discharge)|||kilograms||Standard Deviation|Mean
640097|NCT02364700|Secondary|Stroke Upper Limb Capacity Scale (SULCS)|The SULCs is a performance based measure of upper limb capacity after stroke. Each of the 10 items are administered in a hierarchical order and assigned a score of 0 (unable to complete) or 1 (able to complete the task) with a maximum score of 10.|Baseline to 6 weeks (discharge)|||units on a scale||Standard Deviation|Mean
640098|NCT02364700|Primary|Box and Blocks|The Box and Blocks is a performance-based functional assessment of hand dexterity ( gross grasp and release). The total score is the number of 2.5cc blocks successfully transferred from one box to another with the affected hand in one minute.|Baseline to 6 weeks (discharge)|||totally number of blocks transferred||Standard Deviation|Mean
640099|NCT02364700|Primary|Arm Motor Ability Test (AMAT)|The AMAT is performance based measure of functional ability of the affected arm and hand in unilateral and bilateral everyday tasks. It is comprised of 10 functional tasks such as cutting meat with a knife and fork, donning a t-shirt, and phone use with a score ranging from 0 to a maximum of 5 for each item. The total score is the mean score for all individual item scores.|Baseline to 6 weeks (discharge)|||units on a scale||Standard Deviation|Mean
640100|NCT02364700|Primary|Fugl-Meyer Assessment of Upper Extremity (FMA)|The FMA is a performance based evaluation of upper limb impairment of the affected arm after stroke. Scoring is based on an ordinal scale of 0 (no movement) to 2 (normal movement). Scoring is based on sum of 30 items, ranging from 0-60.|baseline to 6 weeks (discharge)|||units on a scale||Standard Deviation|Mean
640117|NCT02362373|Secondary|Number of Participants Continuing With IUD|Women continuing the IUD for contraception at 6 months|6 months|||participants|||Number
640118|NCT02362373|Secondary|Change in Seizure Frequency|Number of participants with increased, unchanged or decreased mean monthly seizure frequency.|baseline to 6 months|||participants|||Number
640101|NCT02364180|Primary|Percent Change in the Amplitude of Evoked Compound Muscle Action Potential by Electromyography Between the First to Fifth Response|Normally when a nerve is rapidly stimulated the successive Compound Muscle Action Potentials (CMAP) are of the same height. We are hoping to investigate if chronic pyridostigmine therapy reduces the margin of safety and hence the successive CMAPs may be smaller than the preceding ones.|Baseline measurement only. First and Fifth stimuli delivered 2 seconds apart on the same day. There are no additional days/times.|||percent change||Full Range|Median
640102|NCT02363907|Primary|Point Accuracy of CGM ISF Readings to Blood Glucose Measured by a Reference Device|"Point Accuracy was evaluated in terms of the percentage of CGM values that were within ±20% of glucose meter reference value for glucose levels >80 mg/dL and ±20 mg/dL of glucose meter reference values for glucose levels <80 mg/dL"|Measured during clinic session during 7 day sensor wear period|||Percentage of matched pairs w/i %20/20||95% Confidence Interval|Number
640103|NCT02363478|Secondary|Changes in the Severity of Esophageal Symptoms at Week 4|Severity of esophageal symptoms (dysphagia, heartburn, regurgitation and chest pain) was measured on a 100-point visual analogue scale (VAS) ranging from 0 (absent) to 100 (very severe). Even minor decrease in the VAS score for each symptom at week 4 considered as improvement.|before and after 4 weeks buspirone administration|||units on a scale||Standard Deviation|Mean
640104|NCT02363478|Primary|Changes From Baseline in Manometric Parameters: Velocity of Contractions at the Distal Part of the Esophagus at Week 4||before and after 4 weeks buspirone administration|||cm/sec||Standard Deviation|Mean
640105|NCT02363478|Primary|Changes From Baseline in Manometric Parameters: Duration of Contractions at the Distal Part of the Esophagus at Week 4||before and after 4 weeks buspirone administration|||sec||Standard Deviation|Mean
640106|NCT02363478|Primary|Changes From Baseline in Manometric Parameters: i) Amplitude of Contractions at the Distal Part of the Esophagus and ii) Resting and Residual (Lower Esophageal Pressure) LES Pressure and IRP (Integrated Relaxation Pressure) at Week 4||before and after 4 weeks buspirone administration|||mmHg||Standard Deviation|Mean
640107|NCT02363270|Primary|Overall Rate of Feeling Unreality|Overall rate of feeling of unreality as measured by Side Effects Rating Scale for Dissociative Anesthetics (SERSDA)|30 minutes|||Participants|||Count of Participants
640108|NCT02362412|Secondary|Number of Participants With Adverse Events|An adverse event (AE) is defined as any undesirable or unintended sign (including abnonmal laboratory test values), symptom, or disease occurring while the study drug was administered, regardless of whether or not there was a causal relationship with the study drug. A serious AE is defined as a an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important.|Up to 22 weeks|Safety Analysis Set (SAF), which included participants who received at least one dose of study drug.||Participants|||Number
640109|NCT02362412|Secondary|Clinical Global Impression-Bipolar-Change (CGI-BP-C):Mania|The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score.|Week 8 of each treatment period (Week 12 and Week 20)|Full Analysis Set (FAS)||Units on a scale||Standard Deviation|Mean
640110|NCT02362412|Secondary|Clinical Global Impression-Bipolar-Change (CGI-BP-C):Depression|The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score.|Week 8 of each treatment period (Week 12 and Week 20)|Full Analysis Set (FAS)||Units on a scale||95% Confidence Interval|Least Squares Mean
640111|NCT02362412|Secondary|Clinical Global Impression-Bipolar-Change (CGI-BP-C):Overall Bipolar Illness|The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score.|Week 8 of each treatment period (Week 12 and Week 20)|Full Analysis Set (FAS)||Units on a scale||95% Confidence Interval|Least Squares Mean
640112|NCT02362412|Secondary|Clinical Global Impression-Bipolar-Severity of Illness (CGI-BP-S): Mania|The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from with the scale from 1 (Normal, not ill) to 7 (very severely ill)|Week 8 of each treatment period (Week 12 and Week 20)|Full Analysis Set (FAS)||Units on a scale||Standard Deviation|Mean
640113|NCT02362412|Secondary|Clinical Global Impression-Bipolar-Severity of Illness (CGI-BP-S):Depression|The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from with the scale from 1 (Normal, not ill) to 7 (very severely ill).|Week 8 of each treatment period (Week 12 and Week 20)|Full Analysis Set (FAS)||Units on a scale||95% Confidence Interval|Least Squares Mean
640114|NCT02362412|Secondary|Clinical Global Impression-Bipolar-Severity of Illness (CGI-BP-S): Overall Bipolar Illness|The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from with the scale from 1 (Normal, not ill) to 7 (very severely ill).|Week 8 of each treatment period (Week 12 and Week 20)|Full Analysis Set (FAS)||Units on a scale||95% Confidence Interval|Least Squares Mean
640115|NCT02362412|Secondary|Hamilton Depression Scale (HAM-D17)|The HAM-D17 is a clinician-rated 17-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 52 with lower scores indicating less depressive symptoms.|Week 8 of each treatment period (Week 12 and Week 20)|Full Analysis Set (FAS)||Units on a scale||95% Confidence Interval|Least Squares Mean
640116|NCT02362412|Primary|Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms.|Week 8 of each treatment period (Week 12 and Week 20)|Full Analysis Set (FAS)||UNITS ON A SCALE||95% Confidence Interval|Least Squares Mean
640119|NCT02362373|Primary|Percent of Participants That Experienced Clinically Meaningful Change in Oxcarbazepine Level|The outcome measure is designed to examine whether participants will experience subtherapeutic or toxic serum trough level of oxcarbazepine after IUD insertion.|from baseline to 6 months after LNG IUS insertion|3 out of 20 participants received oxcarbazepine while on IUD.||percentage of participants|||Number
640120|NCT02362373|Primary|Percent of Participants That Experienced Clinically Meaningful Change in Levetiracetam Level|The outcome measure is designed to examine whether participants will experience subtherapeutic or toxic serum trough level of levetiracetam after IUD insertion.|from baseline to 6 months after LNG IUS insertion|5 out of 20 participants received levetiracetam while on IUD.||percentage of participants|||Number
640121|NCT02362373|Primary|Percent of Participants That Experienced Clinically Meaningful Change in Lamotrigine Level|The outcome measure is designed to examine whether participants will experience subtherapeutic or toxic serum trough level of lamotrigine after IUD insertion.|from baseline to 6 months after LNG IUS insertion|13 out of 20 participants received lamotrigine while on IUD.||percentage of participants|||Number
640122|NCT02362360|Primary|"Fit to the Peristomal Area, Measured by a 5-point Scale Ranging From Very Poor to Very Good."|"Subjects will evaluate the fit to body for each product by answering the question How was the baseplates ability to fit to the body contours in the area around the stoma?. The question is answered with a 5-point scale ranging from very poor to very good."|21 +/- 3 days|||percentage of subjects answering|||Number
640123|NCT02362321|Primary|Rate of Need for Surgery Drainage|The rate of success of conservative management was defined as the number of patients not requiring surgery in each treatment group during the 6 months following enrollment.|Within 6 months|||participants|||Number
640124|NCT02361736|Secondary|Ratio of the Urine Trace Albumin and Creatinine(ACR) on 5 Time Point|ACR is calculated by the urine trace albumin divided by the urine creatinine|-1d, 0d, 1d, 3d, 5d after surgery|||ratio||Standard Deviation|Mean
640125|NCT02361736|Primary|Concentration of NGAL in Plasma on 5 Time Point.|concentration of NGAL in plasma on 5 time point. Biomarkers are measured by ELISA.|-1d, 0d, 1d, 3d, 5d after surgery|||ng/ml||Standard Deviation|Mean
640126|NCT02361736|Secondary|Estimated Glomerular Filtration Rate(eGFR) on 5 Time Point|eGFR is calculated by concentration of creatinine and CKD-EPI2009|-1d, 0d, 1d, 3d, 5d after surgery|||mL/min/1.73m2||Standard Deviation|Mean
640127|NCT02361736|Secondary|Concentration of β2 Microglobulin in Urine||-1d, 0d, 1d, 3d, 5d after surgery|||mg/L||Standard Deviation|Mean
640128|NCT02361736|Primary|Concentration of IL-18 in Plasma on 5 Time Point||-1d, 0d, 1d, 3d, 5d after surgery|||μg/L||Standard Deviation|Mean
640129|NCT02361736|Primary|Concentration of IL-18 in Urine on 5 Time Point|IL-18 is mainly created from proximal kidney tubules which is a proinflammatory factor that can be detected in earlier urine of AKI animal models.|-1d, 0d, 1d, 3d, 5d after surgery|||μg/L||Standard Deviation|Mean
640130|NCT02361736|Primary|Concentration of NGAL in Urine on 5 Time Point|Neutrophil gelatinase–associated lipocalin (NGAL) is a small protein, which is filtered via the glomeruli and reabsorbed in the proximal tubules, and thus low concentrations of NGAL can be measured in the blood and urine.|-1d, 0d, 1d, 3d, 5d after surgery|||ng/ml||Standard Deviation|Mean
640131|NCT02361580|Secondary|Symptoms of Depression Measured by PROMIS Depression|Symptoms of depression measured by PROMIS Depression|8 weeks|All of the subjects were lost to follow up.|||||
640132|NCT02361580|Secondary|Avoidance of Painful Activities Measured by PROMIS Pain Interference|Avoidance of painful activities measured by PROMIS Pain Interference|8 weeks|All of the subjects were lost to follow up.|||||
640133|NCT02361580|Primary|Upper Extremity Disability Measured by PROMIS Upper Extremity|Upper Extremity Disability measured by PROMIS Upper Extremity|8 weeks|All of the subjects were lost to follow up in both groups.|||||
640134|NCT02360995|Primary|Gingivitis Scores|Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)|6 weeks|||units on a scale||Standard Error|Mean
640135|NCT02360995|Primary|Gingivitis Scores|Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)|4 weeks|||units on a scale||Standard Error|Mean
640136|NCT02360995|Primary|Gingivitis Scores|Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)|Baseline|||units on a scale||Standard Deviation|Mean
640137|NCT02360995|Primary|Dental Plaque Scores|Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|6 weeks|||units on a scale||Standard Error|Mean
640138|NCT02360995|Primary|Dental Plaque Scores|Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|4 weeks|||units on a scale||Standard Error|Mean
640139|NCT02360995|Primary|Dental Plaque Scores|Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|Baseline|||units on a scale||Standard Deviation|Mean
640140|NCT02360475|Secondary|Number of Subjects With SAEs|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Up to study end at Day 360|The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccines administration documented.||Participants|||Count of Participants
640141|NCT02360475|Secondary|Concentrations of PCA|PCA concentrations, expressed as Geometric Mean Concentrations (GMCs). The assay cut-off was greater than or equal to 3.34 micrograms per millilitre (µg/mL).|At Day 90 post-vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which consisted of all subjects from the Total Vaccinated cohort who complied with eligibility criteria, received the study vaccine according to study procedures and had immunogenicity results in the epoch.||µg/mL||95% Confidence Interval|Geometric Mean
640142|NCT02360475|Secondary|Concentrations of PCA|PCA concentrations, expressed as Geometric Mean Concentrations (GMCs).The assay cut-off was greater than or equal to 3.34 micrograms per millilitre (µg/mL).|At Day 60 post-vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which consisted of all subjects from the Total Vaccinated cohort who complied with eligibility criteria, received the study vaccine according to study procedures and had immunogenicity results in the epoch.||µg/mL||95% Confidence Interval|Geometric Mean
640143|NCT02360475|Secondary|Concentrations of PCA|PCA concentrations, expressed as Geometric Mean Concentrations (GMCs). The assay cut-off was greater than or equal to 3.34 micrograms per millilitre (µg/mL).|At Day 30 post-vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which consisted of all subjects from the Total Vaccinated cohort who complied with eligibility criteria, received the study vaccine according to study procedures and had immunogenicity results in the epoch.||µg/mL||95% Confidence Interval|Geometric Mean
640144|NCT02360475|Secondary|Concentrations of Palivizumab Competing Antibodies (PCA)|Palivizumab competing antibody concentrations, expressed as Geometric Mean Concentrations (GMCs). The assay cut-off was greater than or equal to 3.34 micrograms per millilitre (µg/mL).|At Day 0 pre-vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which consisted of all subjects from the Total Vaccinated cohort who complied with eligibility criteria, received the study vaccine according to study procedures and had immunogenicity results in the epoch.||µg/mL||95% Confidence Interval|Geometric Mean
640145|NCT02360475|Secondary|Titres of RSV-A Neutralizing Antibodies|RSV-A neutralizing antibody titres, expressed as Geometric Mean Titres (GMTs), were defined as any titre greater than or equal to (≥) the cut-off 8 serum dilution inducing 60 % inhibition in plaque forming units (ED60).|At Day 90 post-vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which consisted of all subjects from the Total Vaccinated cohort who complied with eligibility criteria, received the study vaccine according to study procedures and had immunogenicity results in the epoch.||Titres||95% Confidence Interval|Geometric Mean
640146|NCT02360475|Secondary|Titres of RSV-A Neutralizing Antibodies|RSV-A neutralizing antibody titres, expressed as Geometric Mean Titres (GMTs), were defined as any titre greater than or equal to (≥) the cut-off 8 serum dilution inducing 60 % inhibition in plaque forming units (ED60).|At Day 60 post-vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which consisted of all subjects from the Total Vaccinated cohort who complied with eligibility criteria, received the study vaccine according to study procedures and had immunogenicity results in the epoch.||Titres||95% Confidence Interval|Geometric Mean
640147|NCT02360475|Primary|Titres of RSV-A Neutralizing Antibodies|RSV-A neutralizing antibody titres, expressed as Geometric Mean Titres (GMTs). Seropositive subjects were defined as subjects whose antibody titre was greater than or equal to (≥) the cut-off 8 serum dilution that induced 60 % inhibition in plaque forming units (ED60).|At Day 30 post-vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which consisted of all subjects from the Total Vaccinated cohort who complied with eligibility criteria, received the study vaccine according to study procedures and had immunogenicity results in the epoch.||Titres||95% Confidence Interval|Geometric Mean
640148|NCT02360475|Primary|Titres of RSV-A Neutralizing Antibodies|RSV-A neutralizing antibody titres, expressed as Geometric Mean Titres (GMTs). Seropositive subjects were defined as subjects whose antibody titre was greater than or equal to (≥) the cut-off 8 serum dilution that induced 60 % inhibition in plaque forming units (ED60).|At Day 0 pre-vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which consisted of all subjects from the Total Vaccinated cohort who complied with eligibility criteria, received the study vaccine according to study procedures and had immunogenicity results in the epoch.||Titres||95% Confidence Interval|Geometric Mean
640149|NCT02360475|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From vaccination at Day 0, up to Day 30 post-vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccines administration documented.||Participants|||Count of Participants
640150|NCT02360475|Primary|Number of Subjects With Unsolicited Adverse Events (AEs)|"An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination."|During the 30-Day (Days 0-29) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccines administration documented.||Participants|||Count of Participants
640151|NCT02360475|Primary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms (symp.) were headache, fever [defined as oral temperature (temp.) equal to or above 37.5 degrees Celsius (°C)], fatigue, gastrointestinal (Gastro.) symptoms [nausea, vomiting, diarrhoea and/or abdominal pain]. Any = occurrence of the symptom regardless of intensity grade and relationship. Grade 3 (G3) symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccines administration documented and with the symptoms sheet filled in.||Participants|||Count of Participants
640180|NCT02359903|Secondary|Maximum Concentration of Infliximab After the Single Infusion of BCD-055/Remicade|Patients who received at least 1 injection. From BCD-055 group 1 patient was excluded because of violation of timing of blood collection. From Remicade group 2 patients were excluded due to AE/SAE.|2 weeks|||ng/ml||Inter-Quartile Range|Median
640152|NCT02360475|Primary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = Significant pain at rest, pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling with a maximum diameter greater than 100 millimeters (mm).|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccines administration documented and with the symptoms sheet filled in.||Participants|||Count of Participants
640153|NCT02360124|Secondary|Proportion of Inactive Root Caries Lesions|the proportion of active tooth root caries lesions at baseline that has changed to inactive root caries lesions at the evaluation examination will be calculated. The calculation is to divide the number of caries lesions that have changed status from active to inactive (assessed in clinical examination) by the number of active caries lesions found at baseline|30 months|The participants were the active root caries lesions found at baseline in each group.||percentage of inactive root caries|||Number
640154|NCT02360124|Primary|Number of New Tooth Root Caries Lesions|the number of new tooth root caries lesions, i.e. tooth roots that have changed from sound at baseline to decayed at the evaluation examination will be counted in the clinical examination|30 months|||new carious root surfaces||Standard Error|Mean
640155|NCT02360059|Primary|Mean Change in Neuropathy|Change in neuropathy as assessed with the chemotherapy-induced peripheral neuropathy (CIPN) survey QLQ-CIPN20 between T1 and T5 where difference in mean area under the curve (AUC) between groups reported. The AUC for response from T1 to T5 is computed by fitting a series of trapezoids to the QLQ-CIPN20 data assessed at T1, T2, T3, T4, and T5, respectively, and summing up their areas [AUC calculated - base of a trapezoid corresponds to the number of days between assessments, and the heights correspond to two adjoining symptom responses, number of trapezoids depends on number of symptom assessments and sum of area for all trapezoids represents AUC of particular participant]. QLQ-CIPN20 contains 20 items assessing sensory (9 items), motor (8 items), and autonomic symptoms (3 items) using a 4-point Likert scale (1 = “not at all,” 2 = “a little,” 3 = “quite a bit,” and 4 = “very much”) with the higher score denoting more symptom burden.|Up to 14 weeks, assessed every 3 weeks ±1 week (T2, T3, T4, T5) during paclitaxel therapy|Study stopped early with only one participant, analysis not possible.|||||
640156|NCT02359955|Primary|EMG (Masseters EMG Are Recorded After Patient Wears Complete Denture for Three Months)|"the masseters EMG are recorded after patient wears complete denture for three months,EMGs of masseters of 20 chewing strokes were recorded in term of value of amp and duration, duration here is reporteds the average value from 20 chewing strokes in units of millisecond."|three month|||millisecond||Standard Deviation|Mean
640157|NCT02359955|Primary|EMG (Masseters EMG Are Recorded After Patient Wears Complete Denture for Three Months)|"the masseters EMG are recorded after patient wears complete denture for three months,EMGs of masseters of 20 chewing strokes were recorded in term of value of amp and duration,amplitude is reported here as the average value from 20 chewing strokes in units of microvolts."|three months|||microvolts||Standard Deviation|Mean
640158|NCT02359955|Secondary|Masticatory Efficiency Index|the masticatory efficiency is tested after patient wears complete denture for three months,each patient was given 4 gram dry peanuts, chewed for 20 seconds, then spat in the receptacle and rinsed mouth residue. The peanut particles were diluted to 1000 ml with distilled water, stirred for 1 minutes and standing for 2 minutes to suspension. Absorbance values(av) were measured at the wavelength of 590nm in a spectrophotometer. The higher the masticatory efficiency, the smaller the peanut particles, then the higher the av value, vice versa. Value of av was used to represent masticatory efficiency. For each patient, the test was conducted three times, and the average value of av was taken as the final result. A lower masticatory efficiency index indicates larger peanut particle size observed.|three months|||index score||Standard Deviation|Mean
640159|NCT02359903|Other Pre-specified|Area Under the Plasma Concentration-time Curve at Steady State Phase||28 weeks||12/2016||||
640160|NCT02359903|Other Pre-specified|Maximum Concentration at Steady State||28 weeks||12/2016||||
640161|NCT02359903|Secondary|Frequency of Early Withdrawal Due to AE/SAE||30 weeks||||||
640162|NCT02359903|Secondary|Percentage of Patients in Whom Bind or Neutralizing Antibodies to Infliximab Were Detected||screening / 14 weeks / 30 weeks||||||
640163|NCT02359903|Secondary|Total Frequency of Grade 3-4 Laboratory Abnormalities Within the Whole Time of the Study||30 weeks||||||
640164|NCT02359903|Secondary|Total Frequency of AE/SAE Within the Whole Time of the Study||30 weeks||||||
640165|NCT02359903|Secondary|Frequency of AE/SAE After the Single Infusion of BCD-055/Remicade||2 weeks||||||
640166|NCT02359903|Secondary|Mean Change of Chest Expansion Compared With Baseline||14 weeks / 30 weeks||||||
640167|NCT02359903|Secondary|Mean Change of SF36 Score Compared With Baseline||14 weeks / 30 weeks||||||
640168|NCT02359903|Secondary|Mean Change of MASES Score Compared With Baseline||14 weeks / 30 weeks||||||
640169|NCT02359903|Secondary|Mean Change of BASFI Score Compared With Baseline||14 weeks / 30 weeks||||||
640170|NCT02359903|Secondary|Mean Change of BASMI Score Compared With Baseline||14 weeks / 30 weeks||||||
640171|NCT02359903|Secondary|Mean Change of BASDAI Score Compared With Baseline||14 weeks / 30 weeks||||||
640172|NCT02359903|Secondary|Percentage of Patients in Each Group Achieving ASAS40||14 weeks / 30 weeks||||||
640173|NCT02359903|Secondary|Percentage of Patients in Each Group Achieving ASAS20||14 weeks / 30 weeks||||||
640174|NCT02359903|Secondary|Average Concentration of Infliximab at Steady State Phase||28 weeks||||||
640175|NCT02359903|Secondary|Half Life of Infliximab After the 1st and 5th Infusion of BCD-055/Remicade||2 weeks / 28 weeks||||||
640176|NCT02359903|Secondary|Time of Maximum Concentration of Infliximab After the1st, 2nd, 3rd, 4th and 5th Infusion of BCD-055/Remicade||28 weeks||||||
640177|NCT02359903|Secondary|Minimum Concentration of Infliximab After the 1st, 2nd, 3rd, 4th and 5th Infusion of BCD-055/Remicade||28 weeks||||||
640178|NCT02359903|Secondary|Maximum Concentration of Infliximab After the 1st, 2nd, 3rd, 4th and 5th Infusion of BCD-055/Remicade||28 weeks||||||
640179|NCT02359903|Secondary|Time of Maximum Concentration of Infliximab After the Single Infusion of BCD-055/Remicade||2 weeks||||||
640405|NCT02353442|Primary|Scapular Kinematics at 4weeks (Pre and Post Treatment)|It was assessed in degrees with 3D system pre and post treatment.|4 weeks: Baseline (pre-treatment), and 4 weeks (post-treatment)|||degrees||Standard Error|Mean
640181|NCT02359903|Primary|Area Under the Plasma Concentration-time Curve From Zero (0) Hours to 336 Hours After the Single Infusion of BCD-055/Remicade||2 weeks|Patients who received at least 1 injection. From BCD-055 group 1 patient was excluded because of violation of timing of blood collection. From Remicade group 2 patients were excluded due to AE/SAE.||(ng/ml)*hour||Inter-Quartile Range|Median
640182|NCT02359877|Primary|Adverse Event (AE) and Serious Adverse Event (SAE) Incidence BCD-054 - 180 mcg - SC/IM|Stage 2 BCD-054 - 180 mcg - SC/IM|4 weeks|||participants|||Number
640183|NCT02359877|Primary|Adverse Event (AE) and Serious Adverse Event (SAE) Incidence|Stage 1|4 weeks|||participants|||Number
640184|NCT02359877|Primary|AUC(0-∞), AUC(0-last) of Neopterin|Stage 2 primary outcome measure for pharmacodynamics analysis. Area under concentration-time curve (AUC) of neopterin from the moment of drug administration until last quantifiable concentration|0 to 672 hours|||(nmol/L)*hour||Inter-Quartile Range|Median
640185|NCT02359877|Primary|AUC (0-168); AUC (0-336); AUC (0-672);AUC (0-∞ ) of Neopterin|Stage 1 primary outcome measure for pharmacodynamics analysis. Area under concentration-time curve (AUC) of neopterin from the moment of drug administration until 168, 336, 648 hours respectively|0 to 168 hours; 0 to 336 hours; 0 to 672 hours respectively|||nmol/L*hour||Inter-Quartile Range|Median
640186|NCT02359877|Primary|AUC(0-last); AUC (0-∞ ) BCD-054 of Interferon (IFN) Beta-1a - 180 mcg - SC, BCD-054 - 180 mcg - IM|Stage 2 primary outcome measure for pharmacokinetics analysis. Area under concentration-time curve (AUC) of interferon (IFN) beta-1a from the moment of drug administration until last quantifiable concentration|0 to 672 hours|||(pg/ml)*hour||Inter-Quartile Range|Median
640187|NCT02359877|Primary|AUC (0-168); AUC (0-336); AUC (0-672); AUC (0-∞ ) of Interferon (IFN) Beta-1a|Stage 1 primary outcome measure for pharmacokinetics analysis. Area under concentration-time curve (AUC) of interferon (IFN) beta-1a from the moment of drug administration up to 168, 336, 648 hours respectively|0 to 168 hours; 0 to 336 hours; 0 to 672 hours respectively|||(pg/ml)*hour||Inter-Quartile Range|Median
640188|NCT02359435|Primary|Number of Participants in Which H. Pylori Was Eradicated|Evaluate eradication outcome by endoscopy urease test and histology or urea breath test|at the 6th week after the end of anti- H. pylori therapy|Intention to treat||participants|||Number
640189|NCT02359045|Secondary|Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects With Clinically Significant Urinalysis|To evaluate the safety by assessing the number of subjects with clinically significant urinalysis results after administration of single doses of the omega-3-carboxylic acids test formulations and Epanova in healthy subjects|From screening (within 28 days of first dosing) up to 14 days after last dosing|Subjects were analyzed based on safety analysis set. Safety Analysis Set is defined as All subjects who received at least one dose of IMP were included in the safety analysis for the study.||Participants|||Number
640190|NCT02359045|Secondary|Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects With Clinically Significant Clinical Chemistry Laboratory Results|To evaluate the safety by assessing the number of subjects with clinically significant clinical chemistry laboratory results after administration of single doses of the omega-3-carboxylic acids test formulations and Epanova in healthy subjects|From screening (within 28 days of first dosing) up to 14 days after last dosing|Subjects were analyzed based on safety analysis set. Safety Analysis Set is defined as All subjects who received at least one dose of IMP were included in the safety analysis for the study.||Participants|||Number
640191|NCT02359045|Secondary|Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects With Clinically Significant Hematology Parameters|To evaluate the safety by assessing the number of subjects with clinically significant hematology parameters after administration of single doses of the omega-3-carboxylic acids test formulations and Epanova in healthy subjects|From screening (within 28 days of first dosing) up to 14 days after last dosing|Subjects were analyzed based on safety analysis set. Safety Analysis Set is defined as All subjects who received at least one dose of IMP were included in the safety analysis for the study.||Participants|||Number
640192|NCT02359045|Secondary|Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects With Clinically Significant 12-lead Electrocardiograms (ECGs)|To evaluate the safety by assessing the number of subjects with clinically significant 12-lead ECGs after administration of single doses of the omega-3-carboxylic acids test formulations and Epanova in healthy subjects|From screening (within 28 days of first dosing) up to 14 days after last dosing|Subjects were analyzed based on safety analysis set. Safety Analysis Set is defined as All subjects who received at least one dose of IMP were included in the safety analysis for the study.||Participants|||Number
640193|NCT02359045|Secondary|Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects With Clinically Significant Pulse|To evaluate the safety by assessing the number of subjects with clinically significant pulse after administration of single doses of the omega-3-carboxylic acids test formulations and Epanova in healthy subjects|From screening (within 28 days of first dosing) up to 14 days after last dosing|Subjects were analyzed based on safety analysis set. Safety Analysis Set is defined as All subjects who received at least one dose of IMP were included in the safety analysis for the study.||Participants|||Number
640194|NCT02359045|Secondary|Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects With Clinically Significant Blood Pressure|To evaluate the safety by assessing the number of subjects with clinically significant blood pressure after administration of single doses of the omega-3-carboxylic acids test formulations and Epanova in healthy subjects|From screening (within 28 days of first dosing) up to 14 days after last dosing|Subjects were analyzed based on safety analysis set. Safety Analysis Set is defined as All subjects who received at least one dose of IMP were included in the safety analysis for the study.||Participants|||Number
640195|NCT02359045|Secondary|Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects Who Had at Least One Adverse Event|To assess the safety by analyzing the number of subjects with at least one adverse event after administration of single doses of the omega-3-carboxylic acids test formulations and Epanova in healthy subjects|From screening (within 28 days of first dosing) up to 14 days after last dosing.|Subjects were analyzed based on safety analysis set. Safety Analysis Set is defined as All subjects who received at least one dose of IMP were included in the safety analysis for the study.||Partcipants|||Number
640196|NCT02359045|Secondary|Safety of Omega-3-carboxylic Acids by Assessing Summary of Adverse Events|To assess the safety summary of single doses of the omega-3-carboxylic acids test formulations and Epanova in healthy subjects|From screening (within 28 days of first dosing) up to 14 days after last dosing|Subjects were analyzed based on safety analysis set. Safety Analysis Set is defined as All subjects who received at least one dose of IMP were included in the safety analysis for the study.||Participants|||Number
640197|NCT02359045|Secondary|λz Assessed for Total (Combined) EPA + DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of λz for Total (combined) EPA + DHA on baseline subtracted plasma concentrations.|Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.||(1/h)||Geometric Coefficient of Variation|Geometric Mean
640198|NCT02359045|Secondary|λz Assessed for DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of λz for DHA on baseline subtracted plasma concentrations.|Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.||(1/h)||Geometric Coefficient of Variation|Geometric Mean
640199|NCT02359045|Secondary|Terminal Elimination Rate Constant (λz ) Assessed for EPA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of λz for EPA on baseline subtracted plasma concentrations.|Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.||(1/hour)||Geometric Coefficient of Variation|Geometric Mean
640200|NCT02359045|Secondary|Tmax Assessed for Total (Combined) EPA + DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of tmax for Total (combined) EPA + DHA on baseline subtracted plasma concentrations.|Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.||(hour)||Full Range|Median
640201|NCT02359045|Secondary|Tmax Assessed for DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of tmax for DHA on baseline subtracted plasma concentrations.|Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.||(hour)||Full Range|Median
640202|NCT02359045|Secondary|Time to Reach Maximum Observed Concentration (Tmax) Assessed for EPA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of tmax for EPA on baseline subtracted plasma concentrations.|Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.||(hour)||Full Range|Median
640203|NCT02359045|Secondary|t½λz Assessed for Total (Combined) EPA + DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of t½λz for Total (combined) EPA + DHA on baseline subtracted plasma concentrations.|Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.||(hour)||Geometric Coefficient of Variation|Geometric Mean
640233|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Mean Post-prandial Maximum Glucose During 24 Hours on Continuous Glucose Monitoring System Repeated Measures Analysis||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320||mmol/L||95% Confidence Interval|Mean
640234|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Post-prandial Maximum Glucose on Continuous Glucose Monitoring System Repeated Measures Analysis||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320||mmol/L||95% Confidence Interval|Mean
640204|NCT02359045|Secondary|t½λz Assessed for DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of t½λz for DHA on baseline subtracted plasma concentrations.|Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.||(hour)||Geometric Coefficient of Variation|Geometric Mean
640205|NCT02359045|Secondary|Half-life Associated With Terminal Slope (λz) of a Semi-logarithmic Concentration-time Curve (t½λz) Assessed for EPA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of t½λz for EPA on baseline subtracted plasma concentrations.|Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.||(hour)||Geometric Coefficient of Variation|Geometric Mean
640206|NCT02359045|Secondary|C0 Assessed for Total (Combined) EPA + DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of C0 for Total (combined) EPA + DHA on baseline subtracted plasma concentrations and baseline unadjusted plasma concentrations.|Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.||(nmol/mL)||Geometric Coefficient of Variation|Geometric Mean
640207|NCT02359045|Secondary|C0 Assessed for DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of C0 for DHA on baseline subtracted plasma concentrations and baseline unadjusted plasma concentrations.|Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.||(μg/mL)||Geometric Coefficient of Variation|Geometric Mean
640208|NCT02359045|Secondary|Baseline Concentration (C0) Assessed for EPA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of C0 for EPA on baseline subtracted plasma concentrations and baseline unadjusted plasma concentrations.|Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.||(μg/mL)||Geometric Coefficient of Variation|Geometric Mean
640209|NCT02359045|Secondary|AUC (Last) Assessed for Total (Combined) EPA + DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of AUC (last) for Total (combined) EPA + DHA on baseline subtracted plasma concentrations and baseline unadjusted plasma concentration.|Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.||(nmol*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
640210|NCT02359045|Secondary|AUC (Last) Assessed for DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of AUC (last) for DHA on baseline subtracted plasma concentrations and baseline unadjusted plasma concentration.|Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.||(μg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
640235|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Mean Blood Glucose During 24 Hours on Continuous Glucose Monitoring System Repeated Measures Analysis||From baseline to Week 16|||mmol/L||95% Confidence Interval|Mean
640211|NCT02359045|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Analyte Concentration {AUC (Last)} Assessed for EPA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of AUC (last) for EPA on baseline subtracted plasma concentrations and baseline unadjusted plasma concentration.|Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.||(μg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
640212|NCT02359045|Primary|Cmax Assessed for Total (Combined) EPA + DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of Cmax for Total (combined) EPA + DHA on baseline subtracted plasma concentrations.|Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.||(nmol/mL)||Geometric Coefficient of Variation|Geometric Mean
640213|NCT02359045|Primary|Cmax Assessed for DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of Cmax for DHA on baseline subtracted plasma concentrations.|Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.||(μg/mL)||Geometric Coefficient of Variation|Geometric Mean
640214|NCT02359045|Primary|Maximum Observed Plasma Concentration (Cmax) Assessed for EPA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of Cmax for EPA on baseline subtracted plasma concentrations.|Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.||(μg/mL)||Geometric Coefficient of Variation|Geometric Mean
640215|NCT02359045|Primary|AUC (0-72) Assessed for Total (Combined) EPA + DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of AUC (0-72) for Total (combined) EPA + DHA on baseline subtracted plasma concentrations.|Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.||(nmol*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
640216|NCT02359045|Primary|AUC (0-72) Assessed for DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000mg) under fasted (Part 1) and fed condition (Part 2), by assessment of AUC (0-72) for DHA on baseline subtracted plasma concentrations.|Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.||(μg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
640217|NCT02359045|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to 72 Hours After Dosing {AUC(0-72)} Assessed for EPA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000mg) under fasted (Part 1) and fed condition (Part 2), by assessment of AUC (0-72) for EPA on baseline subtracted plasma concentrations.|Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.||(μg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
640236|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in 3 Hour Post-prandial Mean Blood Glucose on Continuous Glucose Monitoring System Repeated Measures Analysis||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320||mmol/L||95% Confidence Interval|Mean
640218|NCT02359045|Primary|AUC Assessed for Total (Combined) EPA + DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000mg) under fasted (Part 1) and fed condition (Part 2), by assessment of AUC for Total (combined) EPA + DHA on baseline subtracted plasma concentrations.|Pre-dose: -12, -1 and 0 hours and Post dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.||(nmol*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
640219|NCT02359045|Primary|AUC Assessed for Docosahexaenoic Acids (DHA) After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of AUC for DHA on baseline subtracted plasma concentrations.|Pre-dose: -12, -1 and 0 hours and Post dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.||(μg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
640220|NCT02359045|Primary|Area Under the Plasma Concentration-time Curve From Zero to Infinity (AUC) Assessed for Eicosapentaenoic Acid (EPA) After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000mg) under fasted (Part 1) and fed condition (Part 2), by assessment of AUC for EPA on baseline subtracted plasma concentrations.|Pre-dose: -12, -1 and 0 hours and Post dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
640221|NCT02358876|Primary|Percentage of Kinesia One Assessments Performed|Percentage of Kinesia One assessments performed as directed|Two weeks|||percentage of home assessments completed||Standard Deviation|Mean
640222|NCT02358668|Other Pre-specified|Changes in Complete Blood Count in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo||From baseline to Week 4, Week 8, Week 12, and Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320||g/dL||Standard Deviation|Mean
640223|NCT02358668|Other Pre-specified|Changes in Measures of Liver Function in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo||From baseline to Week 4, Week 8, Week 12, and Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320.||IU/L||Standard Deviation|Mean
640224|NCT02358668|Other Pre-specified|Changes in Serum Creatinine in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320||umol/L||Standard Deviation|Mean
640225|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Percent Coefficient of Variation of Blood Glucose Over 24 Hours on Continuous Glucose Monitoring System Repeated Measures Analysis||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320||% of coefficient of variation||95% Confidence Interval|Mean
640226|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Percent Coefficient of Variation of Blood Glucose Over 3 Hours Post-prandial on Continuous Glucose Monitoring System Repeated Measures Analysis||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320||% of coefficient of variation||95% Confidence Interval|Mean
640227|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Percent Coefficient of Variation of Blood Glucose Over 2 Hours Post-prandial on Continuous Glucose Monitoring System Repeated Measures Analysis||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320||% of coefficient of variation||95% Confidence Interval|Mean
640228|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Percent Coefficient of Variation of Blood Glucose Over 1 Hour Post-prandial on Continuous Glucose Monitoring System Repeated Measures Analysis||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320||% of coefficient of variation||95% Confidence Interval|Mean
640229|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Standard Deviation of Blood Glucose Over 24 Hours on Continuous Glucose Monitoring System Repeated Measures Analysis||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320||mmol/L||95% Confidence Interval|Mean
640230|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Standard Deviation of Blood Glucose During 3 Hours Post-prandial on Continuous Glucose Monitoring System Repeated Measures Analysis||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320||mmol/L||95% Confidence Interval|Mean
640231|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Standard Deviation of Blood Glucose During 2 Hours Post-prandial on Continuous Glucose Monitoring System Repeated Measures Analysis||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320||mmol/L||95% Confidence Interval|Mean
640232|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Standard Deviation of Blood Glucose During 1 Hour Post-prandial on Continuous Glucose Monitoring System Repeated Measures Analysis||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320||mmol/L||95% Confidence Interval|Mean
640237|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in 2 Hour Post-prandial Mean Blood Glucose on Continuous Glucose Monitoring System Repeated Measures Analysis||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320||mmol/L||95% Confidence Interval|Mean
640238|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in 1 Hour Post-prandial Mean Blood Glucose on Continuous Glucose Monitoring System Repeated Measures Analysis||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320||mmol/L||95% Confidence Interval|Mean
640239|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Mean 3 Hour Post-prandial Glucose Incremental Area Under Curve on Continuous Glucose Monitoring System Repeated Measures Analysis||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320||mmol/L*hour||95% Confidence Interval|Mean
640240|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Mean 2 Hour Post-prandial Glucose Incremental Area Under Curve on Continuous Glucose Monitoring System Repeated Measures Analysis||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320||mmol/L*hour||95% Confidence Interval|Mean
640241|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Mean 1 Hour Post-prandial Glucose Incremental Area Under Curve on Continuous Glucose Monitoring System Repeated Measures Analysis||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320||mmol/L*hour||95% Confidence Interval|Mean
640242|NCT02358668|Secondary|Changes in Measures of Exercise in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo|Changes in the number of days per week that the subject spent walking for at least 10 minutes from baseline to Week 16|From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320||Days||Standard Deviation|Mean
640243|NCT02358668|Secondary|Changes in Measures of Nutritional Intake in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo|Changes in daily calories intake from baseline to Week 16|From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320||kcal||Standard Deviation|Mean
640244|NCT02358668|Secondary|Changes in Measures of Food Satiety in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo|"Changes to question of how full do you feel in the Appetite Questionnaire adopted from Hill and Blundell from baseline and Week 16. Scale score ranges from minimum of 0 to maximum of 10. 10 being the most full and 0 being the least full."|From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320||units on a scale||Standard Deviation|Mean
640245|NCT02358668|Secondary|Changes in Quality of Life Measures in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo|Changes in WHOQOL-BREF physical health domain score from baseline to Week 16. This is a sub-scale of the WHOQOL-BREF. Possible scores range from minimal of 4 to maximum of 20. Higher score indicate better physical health domain.|From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320||units on a scale||Standard Deviation|Mean
640246|NCT02358668|Secondary|Changes in Urate in Subjects Treated With High Dose and Lose Dose BTI320 Compared to Placebo||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320||mmol/L||Standard Deviation|Mean
640247|NCT02358668|Secondary|Changes in High-sensitivity C-reactive Protein in Subjects Treated With High Dose and Low Dose BTI320 Compared Placebo||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320||mg/L||Standard Deviation|Mean
640248|NCT02358668|Secondary|Changes in Lipids in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo|Changes in total cholesterol from baseline to Week 16.|From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320||mmol/L||Standard Deviation|Mean
640249|NCT02358668|Secondary|Changes in Body Weight in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320||kg||Standard Deviation|Mean
640250|NCT02358668|Secondary|Changes in Waist Circumference in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320||cm||Standard Deviation|Mean
640251|NCT02358668|Secondary|Changes in Blood Pressures in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo|Changes in systolic blood pressures from baseline to Week 16|From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320||mmHg||Standard Deviation|Mean
640252|NCT02358668|Secondary|Proportion of Subjects With Impaired Fasting Glucose or Impaired Glucose Tolerance in Low Dose BTI320, High Dose BTI320 and Placebo Group|Proportion of subjects with impaired fasting glucose, impaired glucose tolerance, both impaired fasting glucose and impaired glucose tolerance, HbA1c 5.7-6.4%, or type 2 diabetes at 30 days post-treatment|From baseline to 30 days post-treatment|Intention to treat, as defined by all subjects who have received at least one dose of BTI320||percentage of subjects|||Number
640253|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Glucagon-like Peptide 1 During Standard Meal Tolerance Test From 0 Minute to 120 Minutes|Changes in area under curve of glucagon-like peptide-1 from 0 minute to 120 minutes from baseline to Week 16|From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320||pmol/L*minute||Standard Deviation|Mean
640254|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Area Under Curve of C-peptide During Standard Meal Tolerance Test From 0 Minute to 120 Minutes|Changes in area under curve of C-peptide from 0 minute to 120 minutes from baseline to Week 16|From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320||ug/L*minute||Standard Deviation|Mean
640255|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Area Under Curve of Insulin During Standard Meal Tolerance Test From 0 Minute to 120 Minutes|Changes in area under curve of insulin from 0 minute to 120 minutes from baseline to Week 16|From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320||mIU/L*minute||Standard Deviation|Mean
640256|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Area Under Curve of Glucose During Standard Meal Tolerance Test From 0 Minute to 120 Minutes|Changes in area under curve of glucose from 0 minute to 120 minutes from baseline to Week 16|From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320||mmol/L*minute||Standard Deviation|Mean
640257|NCT02358668|Secondary|Changes in Fructosamine in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320||umol/L||Standard Deviation|Mean
640258|NCT02358668|Secondary|Changes in HbA1c in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320||percent glycated hemoglobin||Standard Deviation|Mean
640259|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Percent Coefficient of Variation on Continuous Glucose Monitoring System||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320||% of coefficient of variation||Standard Deviation|Mean
640260|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Standard Deviation of Glucose on Continuous Glucose Monitoring System||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320||mmol/L||Standard Deviation|Mean
640261|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Area Under Curve for Glucose Levels >180mg/dL on Continuous Glucose Monitoring System|Area under curve for glucose levels >180 mg/dL over 72 hours|From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320||mmol/L*hour||Standard Deviation|Mean
640262|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Mean Blood Glucose on Continuous Glucose Monitoring System||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320||mmol/L||Standard Deviation|Mean
640263|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Mean Amplitude of Glucose Excursion on Continuous Glucose Monitoring System||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320||mmol/L||Standard Deviation|Mean
640264|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose BTI320 and High Dose BTI320 Compared With Placebo in Mean Post-meal Maximum Glucose on Continuous Glucose Monitoring System||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320||mmol/L||Standard Deviation|Mean
640265|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Mean Post-prandial Glucose Incremental Area Under Curve on Continuous Glucose Monitoring System|"Changes in 3-hour post-prandial glucose incremental area under curve on continuous glucose monitoring system from baseline to Week 16.
Note that this is not a pharmacokinetic study and this is not pharmacokinetic data as we are not measuring drug levels. Here we are examining glucose levels after meals as one of the anticipated glycemic outcomes of using glucose-lowering therapy (BTI320 in this case). With data-analysis based on continuous glucose monitoring, it is conventional to present post-prandial (i.e. post-meal) glucose incremental area under curve at up to 3 hours. It is not meaningful to look at post-meal glucose changes at more than 3 hours after meal for the obvious reason that subject might have taken another meal by then."|From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320||mmol/L*hour||Standard Deviation|Mean
640266|NCT02358668|Primary|Change in Serum Fructosamine in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo||From baseline to Week 4|Intention to treat, as defined by all subjects who have received at least one dose of BTI320.||umol/L||Standard Deviation|Mean
640267|NCT02358044|Secondary|Percentage of Participants Achieving Sustained Virologic Response 4 Weeks After Ending Study Treatment (SVR4)|HCV-RNA levels in plasma were measured using the Roche COBAS®AmpliPrep/COBAS® TaqMan® HCV Test, v2.0 on blood samples drawn from each participant. SVR4 was defined as HCV RNA <LLOQ at 4 weeks after the end of all study therapy.|4 weeks after end of all therapy (Study Week 16)|FAS; all randomized participants who receive at least one dose of study treatment. Two participants in the SOF + PR arm withdrew from study prior to treatment and were excluded from analysis.||percentage of participants||95% Confidence Interval|Number
640268|NCT02358044|Secondary|Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Ending Study Treatment (SVR24)|HCV-RNA levels in plasma were measured using the Roche COBAS®AmpliPrep/COBAS® TaqMan® HCV Test, v2.0 on blood samples drawn from each participant. SVR24 was defined as HCV RNA <LLOQ at 24 weeks after the end of all study therapy.|24 weeks after end of all therapy (Study Week 36)|FAS; all randomized participants who receive at least one dose of study treatment. Two participants in the SOF + PR arm withdrew from study prior to treatment and were excluded from analysis.||percentage of participants|||Number
640269|NCT02358044|Secondary|Percentage of Participants Experiencing at Least One Tier 1 Safety Event (Key Safety Parameter) During the Treatment Period and First 14 Follow-up Days|Tier 1 safety events were pre-specified by the protocol to evaluate safety and test the safety superiority hypothesis. Tier 1 safety events were chosen to assess broad tolerability, hematological side effects and liver-related laboratory abnormalities. For this study, Tier 1 safety events included: any serious drug-related AE, any drug-related AE leading to permanent discontinuation (DC) of all study drugs, neutrophil count <0.75 x 10^9/L, hemoglobin <10 g/dL, severe depression, hepatic events of clinical interest (defined by abnormal increases in alanine aminotransferase [ALT], aspartate aminotransferase [AST], or alkaline phosphatase [ALP]), or events meeting stopping rule criteria for DC from trial (due to abnormal increases of ALT, AST, or ALP with/without pre-specified related AEs). The percentage of participants who experienced each individual event that was defined as a Tier 1 safety event during the study treatment period was reported for each treatment arm.|Treatment + First 14 days of follow-up (Up to Week 14)|ASaT population; all randomized participants who received at least one dose of study treatment. Two participants in the SOF + PR arm withdrew from study prior to treatment and were excluded from analysis.||percentage of participants|||Number
640352|NCT02356588|Secondary|Analysis of Total Number of Doses Used During the 24-Hour Study Period in the ITT Population||24 hours|||mean number of tablets taken||Standard Deviation|Mean
640270|NCT02358044|Primary|Percentage of Participants Discontinuing Study Treatment Due to an AE|"An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that was temporally associated with the use of the Sponsor’s product, was also an AE.
The percentage of participants who discontinued study treatment due to an AE was reported for each treatment arm. Participants that discontinued study drug treatment due to an AE may have still continued on trial."|Up to Week 12|ASaT population; all randomized participants who received at least one dose of study treatment. Two participants in the SOF + PR arm withdrew from study prior to treatment and were excluded from analysis.||percentage of participants|||Number
640271|NCT02358044|Primary|Percentage of Participants Experiencing at Least One Adverse Event (AE) During the Treatment Period Plus First 14 Follow-up Days|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that was temporally associated with the use of the Sponsor’s product, was also an AE. The percentage of participants who experienced at least one AE was reported for each treatment arm.|Treatment + First 14 days of follow-up (Up to Week 14)|All Subjects as Treated (ASaT) population; all randomized participants who received at least one dose of study treatment. Two participants in the SOF + PR arm withdrew from study prior to treatment and were excluded from analysis.||percentage of participants|||Number
640272|NCT02358044|Primary|Primary: Percentage of Participants Achieving Sustained Virologic Response at 12 Weeks After the End of All Treatment (SVR12)|Hepatitis C Virus ribonucleic acid (HCV-RNA) levels in plasma were measured using the Roche COBAS®AmpliPrep/COBAS® TaqMan® HCV Test, v2.0 on blood samples drawn from each participant. SVR12 was defined as HCV RNA below the lower limit of quantification (<LLOQ) at 12 weeks after the end of all study therapy. The primary efficacy hypothesis for this study was that the percentage of participants achieving SVR12 in the grazoprevir plus elbasvir arm was non-inferior to the percentage in the SOF plus PR arm. A secondary statistical analysis was performed to determine whether the percentage of participants achieving SVR12 in the grazoprevir plus elbasvir arm was superior to the percentage in the SOF plus PR arm.|12 weeks after end of all therapy (Study Week 24)|FAS; all randomized participants who receive at least one dose of study treatment. Two participants in the SOF + PR arm withdrew from study prior to treatment and were excluded from analysis.||percentage of participants|||Number
640273|NCT02357940|Primary|Percentage With Scaling on the Torso at Day 14|Percentage of adults and babies with scaling on the torso at Day 14|At Day 14|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
640274|NCT02357940|Primary|Percentage With Scaling on the Legs at Day 14|Percentage of adults and babies with scaling on the legs at Day 14|At Day 14|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
640275|NCT02357940|Primary|Percentage With Scaling on the Arms at Day 14|Percentage of adults and babies with scaling on the arms at Day 14|At Day 14|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
640276|NCT02357940|Primary|Percentage With Scaling on the Face at Day 14|Percentage of adults and babies with scaling on the face at Day 14|At Day 14|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
640277|NCT02357940|Primary|Percentage With Scaling on the Torso at Day 7|Percentage of adults and babies with scaling on the torso at Day 7|At Day 7|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
640278|NCT02357940|Primary|Percentage With Scaling on the Legs at Day 7|Percentage of adults and babies with scaling on the legs at Day 7|At Day 7|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
640279|NCT02357940|Primary|Percentage With Scaling on the Arms at Day 7|Percentage of adults and babies with scaling on the arms at Day 7|At Day 7|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
640280|NCT02357940|Primary|Percentage With Scaling on the Face at Day 7|Percentage of adults and babies with scaling on the face at Day 7|At Day 7|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
640281|NCT02357940|Primary|Percentage With Scaling on the Torso at Day 1|Percentage of adults and babies with scaling on the torso at Day 1|At Day 1|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
640282|NCT02357940|Primary|Percentage With Scaling on the Legs at Day 1|Percentage of adults and babies with scaling on the legs at Day 1|At Day 1|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
640283|NCT02357940|Primary|Percentage With Scaling on the Arms at Day 1|Percentage of adults and babies with scaling on the arms at Day 1|At Day 1|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
640284|NCT02357940|Primary|Percentage With Scaling on the Face at Day 1|Percentage of adults and babies with scaling on the face at Day 1|At Day 1|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
640285|NCT02357940|Primary|Percentage With Scaling on the Torso at Baseline After Investigational Product Application|Percentage of adults and babies with scaling on the torso at baseline after investigational product application|At baseline after investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
640286|NCT02357940|Primary|Percentage With Scaling on the Legs at Baseline After Investigational Product Application|Percentage of adults and babies with scaling on the legs at baseline after investigational product application|At baseline after investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
640287|NCT02357940|Primary|Percentage With Scaling on the Arms at Baseline After Investigational Product Application|Percentage of adults and babies with scaling on the arms at baseline after investigational product application|At baseline after investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
640288|NCT02357940|Primary|Percentage With Scaling on the Face at Baseline After Investigational Product Application|Percentage of adults and babies with scaling on the face at baseline after investigational product application|At baseline after investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
640289|NCT02357940|Primary|Percentage With Scaling on the Torso at Baseline Before Investigational Product Application|Percentage of adults and babies with scaling on the torso at baseline before investigational product application|At baseline before investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
640290|NCT02357940|Primary|Percentage With Scaling on the Legs at Baseline Before Investigational Product Application|Percentage of adults and babies with scaling on the legs at baseline before investigational product application|At baseline before investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
640291|NCT02357940|Primary|Percentage With Scaling on the Arms at Baseline Before Investigational Product Application|Percentage of adults and babies with scaling on the arms at baseline before investigational product application|At baseline before investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
640292|NCT02357940|Primary|Percentage With Scaling on the Face at Baseline Before Investigational Product Application|Percentage of adults and babies with scaling on the face at baseline before investigational product application|At baseline before investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
640293|NCT02357940|Primary|Percentage With Edema on the Torso at Day 14|Percentage of adults and babies with edema on the torso at Day 14|At Day 14|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
640294|NCT02357940|Primary|Percentage With Edema on the Legs at Day 14|Percentage of adults and babies with edema on the legs at Day 14|At Day 14|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
640295|NCT02357940|Primary|Percentage With Edema on the Arms at Day 14|Percentage of adults and babies with edema on the arms at Day 14|At Day 14|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
640296|NCT02357940|Primary|Percentage With Edema on the Face at Day 14|Percentage of adults and babies with edema on the face at Day 14|At Day 14|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
640297|NCT02357940|Primary|Percentage With Edema on the Torso at Day 7|Percentage of adults and babies with edema on the torso at Day 7|At Day 7|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
640298|NCT02357940|Primary|Percentage With Edema on the Legs at Day 7|Percentage of adults and babies with edema on the legs at Day 7|At Day 7|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
640299|NCT02357940|Primary|Percentage With Edema on the Arms at Day 7|Percentage of adults and babies with edema on the arms at Day 7|At Day 7|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
640300|NCT02357940|Primary|Percentage With Edema on the Face at Day 7|Percentage of adults and babies with edema on the face at Day 7|At Day 7|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
640301|NCT02357940|Primary|Percentage With Edema on the Torso at Day 1|Percentage of adults and babies with edema on the torso at Day 1|At Day 1|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
640302|NCT02357940|Primary|Percentage With Edema on the Legs at Day 1|Percentage of adults and babies with edema on the legs at Day 1|At Day 1|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
640303|NCT02357940|Primary|Percentage With Edema on the Arms at Day 1|Percentage of adults and babies with edema on the arms at Day 1|At Day 1|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
640304|NCT02357940|Primary|Percentage With Edema on the Face at Day 1|Percentage of adults and babies with edema on the face at Day 1|At Day 1|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
640305|NCT02357940|Primary|Percentage With Edema on the Torso at Baseline After Investigational Product Application|Percentage of adults and babies with edema on the torso at baseline after investigational product application|At baseline after investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
640306|NCT02357940|Primary|Percentage With Edema on the Legs at Baseline After Investigational Product Application|Percentage of adults and babies with edema on the legs at baseline after investigational product application|At baseline after investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
640353|NCT02356588|Secondary|Analysis of Total Number of Doses Used During the 12-Hour Study Period in the ITT Population||Cumulative through 12 hours|||mean number of tablets taken||Standard Deviation|Mean
640307|NCT02357940|Primary|Percentage With Edema on the Arms at Baseline After Investigational Product Application|Percentage of adults and babies with edema on the arms at baseline after investigational product application|At baseline after investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
640308|NCT02357940|Primary|Percentage With Edema on the Face at Baseline After Investigational Product Application|Percentage of adults and babies with edema on the face at baseline after investigational product application|At baseline after investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
640309|NCT02357940|Primary|Percentage With Edema on the Torso at Baseline Before Investigational Product Application|Percentage of adults and babies with edema on the torso at baseline before investigational product application|At baseline before investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
640310|NCT02357940|Primary|Percentage With Edema on the Legs at Baseline Before Investigational Product Application|Percentage of adults and babies with edema on the legs at baseline before investigational product application|At baseline before investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
640311|NCT02357940|Primary|Percentage With Edema on the Arms at Baseline Before Investigational Product Application|Percentage of adults and babies with edema on the arms at baseline before investigational product application|At baseline before investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
640312|NCT02357940|Primary|Percentage With Edema on the Face at Baseline Before Investigational Product Application|Percentage of adults and babies with edema on the face at baseline before investigational product application|At baseline before investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
640313|NCT02357940|Primary|Percentage With Erythema on the Torso at Day 14|Percentage of adults and babies with erythema on the torso at Day 14|At Day 14|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
640314|NCT02357940|Primary|Percentage With Erythema on the Legs at Day 14|Percentage of adults and babies with erythema on the legs at Day 14|At Day 14|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
640315|NCT02357940|Primary|Percentage With Erythema on the Arms at Day 14|Percentage of adults and babies with erythema on the arms at Day 14|At Day 14|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
640316|NCT02357940|Primary|Percentage With Erythema on the Face at Day 14|Percentage of adults and babies with erythema on the face at Day 14|At Day 14|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
640317|NCT02357940|Primary|Percentage With Erythema on the Torso at Day 7|Percentage of adults and babies with erythema on the torso at Day 7|At Day 7|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
640318|NCT02357940|Primary|Percentage With Erythema on the Legs at Day 7|Percentage of adults and babies with erythema on the legs at Day 7|At Day 7|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
640319|NCT02357940|Primary|Percentage With Erythema on the Arms at Day 7|Percentage of adults and babies with erythema on the arms at Day 7|At Day 7|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
640320|NCT02357940|Primary|Percentage With Erythema on the Face at Day 7|Percentage of adults and babies with erythema on the face at Day 7|At Day 7|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
640321|NCT02357940|Primary|Percentage With Erythema on the Torso at Day 1|Percentage of adults and babies with erythema on the torso at Day 1|At Day 1|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
640322|NCT02357940|Primary|Percentage With Erythema on the Legs at Day 1|Percentage of adults and babies with erythema on the legs at Day 1|At Day 1|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
640323|NCT02357940|Primary|Percentage With Erythema on the Arms at Day 1|Percentage of adults and babies with erythema on the arms at Day 1|At Day 1|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
640324|NCT02357940|Primary|Percentage With Erythema on the Face at Day 1|Percentage of adults and babies with erythema on the face at Day 1|At Day 1|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
640325|NCT02357940|Primary|Percentage With Erythema on the Torso at Baseline After Investigational Product Application|Percentage of adults and babies with erythema on the torso at baseline after investigational product application|At baseline after investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
640326|NCT02357940|Primary|Percentage With Erythema on the Legs at Baseline After Investigational Product Application|Percentage of adults and babies with erythema on the legs at baseline after investigational product application|At baseline after investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
640327|NCT02357940|Primary|Percentage With Erythema on the Arms at Baseline After Investigational Product Application|Percentage of adults and babies with erythema on the arms at baseline after investigational product application|At baseline after investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
640328|NCT02357940|Primary|Percentage With Erythema on the Face at Baseline After Investigational Product Application|Percentage of adults and babies with erythema on the face at baseline after investigational product application|At baseline after investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
640329|NCT02357940|Primary|Percentage With Erythema on the Torso at Baseline Before Investigational Product Application|Percentage of adults and babies with erythema on the torso at baseline before investigational product application|At baseline before investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
640330|NCT02357940|Primary|Percentage With Erythema on the Legs at Baseline Before Investigational Product Application|Percentage of adults and babies with erythema on the legs at baseline before investigational product application|At baseline before investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
640331|NCT02357940|Primary|Percentage With Erythema on the Arms at Baseline Before Investigational Product Application|Percentage of adults and babies with erythema on the arms at baseline before investigational product application|At baseline before investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
640332|NCT02357940|Primary|Percentage With Erythema on the Face at Baseline Before Investigational Product Application|Percentage of adults and babies with erythema on the face at baseline before investigational product application|At baseline before investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
640333|NCT02357485|Secondary|Comparison of Baseline Score and 3 Months Score in Timed-Up-and-Go (TUG).|Comparison of baseline time for subjects' ability to rapidly rise from a chair, move rapidly 2 meters from the chair, turn and return and sit in the chair to the same measure at 3 months. Time to complete task is measured in seconds.|baseline to 3 months|||seconds||Standard Deviation|Mean
640334|NCT02357485|Secondary|Comparison of Baseline and 3 Months Measures of Knee Flexion for Range of Motion|Comparison of baseline measure of knee flexion to 3 months measurements of knee flexion. An increase in range of motion is positive (improved ability to move) and a decrease in range of motion is negative.|Baseline to 3 months|||degrees|Participants|Standard Deviation|Mean
640335|NCT02357485|Secondary|Comparison of Baseline Score and 1 Year Score in Visual Analog Scale (VAS) for Pain|Comparison of VAS pain score as measured before treatment and 3 months and 1 year after treatment. VAS measured on a scale of 0 (no pain) to 10 (worst possible pain).|Baseline to 1 year|||units on a scale|Participants|Standard Deviation|Mean
640336|NCT02357485|Secondary|Comparison of Baseline Score and 1 Year Score in Western Ontario and McMaster Universities Arthritis Index (WOMAC)|"Comparison of WOMAC score (pain, stiffness and functionality measures) measured at baseline (pre-treatment), 3 months and 1 year (post treatment).
WOMAC score: 0 (best) to 100 (worst)"|Baseline to 1 year|||units on a scale|Participants|Standard Deviation|Mean
640337|NCT02357485|Primary|Safety as Measured by Adverse Events|Adverse Events were recorded during the entirety of the study.|Entire Study (1 year)|All 6 participants were included in the analysis||percentage of participants|||Number
640338|NCT02357342|Secondary|Visual Acuity (Best Corrected Visual Acuity)|number of subjects with gain of 5 or more letters of visual acuity|baseline to 6 months|||participants||100% Confidence Interval|Number
640339|NCT02357342|Primary|Visual Acuity|number of subjects with gain of 0-4 letters of visual acuity|Baseline to 6 months|||Participants|||Count of Participants
640340|NCT02357342|Primary|Change in Edema From Baseline to Month 6 Central Subfield Thickness ) on Heidelberg Optical Coherence Topography|Change in edema from baseline to month 6 as measured by mean difference in microns of central subfield thickness on Heidelberg optical coherence topography in each treatment group|Baseline to 6 months|||microns||Full Range|Mean
640341|NCT02357264|Primary|Detection of Fluid in the Lungs|Detection of Fluid in the lungs in patients with pre-eclampsia vs. pregnant patients without pre-eclampsia|24-36 weeks|||Participants|||Count of Participants
640342|NCT02356900|Primary|Muscle Phenotype Change|Immunofluorescence microscopy using citrate synthase staining|Baseline/24 hrs Post-training|Muscle Biopsy samples were not analyzed due to funding issues.|||||
640343|NCT02356900|Primary|COX-I Gene Expression Change|Real-time PCR|Baseline/24 hrs Post-training|Muscle Biopsy samples were not analyzed due to funding issues.|||||
640344|NCT02356900|Primary|Pgc-1a Coactivator Muscle Protein Content Change|Western analysis|Baseline/24 hrs Post-training|Muscle Biopsy samples were not analyzed due to funding issues.|||||
640345|NCT02356900|Primary|Tfam Muscle Protein Content Change|Western analysis|Baseline/24 hrs Post-training|Muscle Biopsy samples were not analyzed due to funding issues.|||||
640346|NCT02356900|Primary|Mitochondrial Mass Change|Immunofluorescence microscopy using citrate synthase staining|Baseline/24 hrs Post-training|Muscle Biopsy samples were not analyzed due to funding issues.|||||
640347|NCT02356900|Primary|Change in Ventilatory Threshold (VT) From Baseline to Post-training (<72 Hours)|Graded exercise test to exhaustion at simulated 15000 ft altitude|Baseline and <72 hrs Post-training|Three participants in the Hyperoxic, Hyperbaric group and one participant in the Normoxic, Normobaric group were not included in the analysis due to experimental errors.||mL/kg/min||Standard Deviation|Mean
640348|NCT02356900|Primary|Change in Maximum Aerobic Capacity (VO2max) From Baseline to Post-training (< 72 Hours )|Graded exercise test to exhaustion at simulated 15000 ft altitude|Baseline and <72 hrs Post-training|Three participants in the Hyperoxic, Hyperbaric group and one participant in the Normoxic, Normobaric group were not included in the analysis due to experimental errors.||mL/kg/min||Standard Deviation|Mean
640349|NCT02356588|Secondary|Summary of Number of Rescue Morphine Doses Used by Study Period in the ITT Population||Cumulative through 24 hours|||mean number of doses used||Standard Deviation|Mean
640350|NCT02356588|Secondary|Summary of Number of Rescue Morphine Doses Used by Study Period in the ITT Population||Cumulative through 12 hours|||mean number of doses used||Standard Deviation|Mean
640351|NCT02356588|Secondary|Summary of Number of Rescue Morphine Doses Used by Study Period in the ITT Population||Cumulative through 6 hours|||mean number of doses used||Standard Deviation|Mean
640354|NCT02356588|Secondary|Summed Pain Intensity Difference|"The SPID-1 is calculated by summing the difference to baseline between baseline pain score and the pain score at each assessment time point through 1 hour.
The observed SPID scores ranged from -2.00 to 5.25 in the active group to -4.90 to 3.00 in the placebo group. A negative score indicates an increase in pain intensity and a higher score indicates a greater decrease in pain intensity."|1 hour|||units on a scale||Standard Error|Least Squares Mean
640355|NCT02356588|Secondary|Healthcare Professional Global Assessment|Proportion of Health Care Professionals who responded good or excellent to the global assessment of method of pain control at 24 hours|24 hours|||Percentage of HCPs||95% Confidence Interval|Number
640356|NCT02356588|Secondary|Patient Global Assessment|Proportion of patients who responded good or excellent to the global assessment of method of pain control at 24 hours|24 hours|||Percentage of patients||95% Confidence Interval|Number
640357|NCT02356588|Secondary|Time-weighted SPRID24|Time-weighted summed pain relief intensity difference (SPRID) over the 24 hour study period. The observed SPRID scores ranged from -49.67 to 222.04 in the active group and -24.97 to 237.54 in the placebo group. A negative score indicates an increase in pain intensity and decrease in pain relief, while a higher score indicates a greater decrease in pain intensity and increase in pain relief.|24 hours|||units on a scale||Standard Error|Least Squares Mean
640358|NCT02356588|Secondary|Time-weighted SPRID12|Time-weighted summed pain relief intensity difference (SPRID) over the 12 hour study period. The observed SPRID scores ranged from -38.08 to 106.82 in the active group and -20.10 to 95.72 in the placebo group. A negative score indicates an increase in pain intensity and decrease in pain relief, while a higher score indicates a greater decrease in pain intensity and increase in pain relief.|12 hours|||units on a scale||Standard Error|Least Squares Mean
640359|NCT02356588|Secondary|TOTPAR24|Total pain relief over the 24 hour study period. The observed total pain relief scores ranged from 12.35 to 95.23 in the active group and 2.61 to 82.04 in the placebo group. A higher score indicates greater pain relief.|24 Hours|||units on a scale||Standard Error|Least Squares Mean
640360|NCT02356588|Secondary|TOTPAR12|Total pain relief over the 12 hours. The observed total pain relief scores ranged from 4.08 to 47.50 in the active group and 1.77 to 33.71 in the placebo group. A higher score indicates greater pain relief.|12 hours|||units on a scale||Standard Error|Least Squares Mean
640361|NCT02356588|Secondary|Time-weighted Summed Pain Intensity Difference (SPID) Over the 24-hour Study Period (SPID24).|The primary outcome measure is the summed pain intensity difference to baseline over the 24-hour study period (SPID-24). A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and throughout the 24 hour study period. The SPID-24 is calculated by summing the difference between baseline pain score and pain score at each assessment time point. The observed SPID-24 scores ranged from -70.00 to 148.70 in the active group to -58.09 to 160.24 in the placebo group. A negative score indicates an increase in pain intensity and a higher score indicates a greater decrease in pain intensity.|24 hours|||units on a scale||Standard Error|Least Squares Mean
640362|NCT02356588|Primary|Time-weighted Summed Pain Intensity Difference (SPID) Over the 12-hour Study Period (SPID12).|"The primary outcome measure is the summed pain intensity difference to baseline over the 12-hour study period (SPID-12). A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and throughout the 12 hour study period. The SPID-12 is calculated by summing the difference between baseline pain score and pain score at each assessment time point.
The observed SPID-12 scores ranged from -42.15 to 71.87 in the active group and -34.96 to 64.37 in the placebo group. A negative score indicates an increase in pain intensity and a higher score indicates a greater decrease in pain intensity."|12 hours|||units on a scale||Standard Error|Least Squares Mean
640363|NCT02355977|Secondary|Bacterial Load|Real-time quantitative PCR (qRT-PCR) was used as a powerful tool with high sensitivity and specificity to quantitatively assess target periodontal bacteria.|7 days|The analyzed units of the gene load of bacteria are log10.||log10 (copies/ml)||Standard Deviation|Mean
640364|NCT02355977|Secondary|Bleeding on Probing|BOP is evaluated for the treated tooth using the sulcus bleeding index (SBI) by Muhlemann with a range of 0 (no bleeding) to 5 (profuse bleeding)|7 days|||units on a scale||Standard Deviation|Mean
640365|NCT02355977|Primary|Pocket Depth|PD is measured using a standard CPI（community periodontal index） probe (Shanghai Medical Instruments, Shanghai, China) and assessed to the nearest millimeter.|7 days|||mm||Standard Deviation|Mean
640366|NCT02355275|Secondary|Numeric Pain Rating Scale|The Numeric Pain Rating Scale (NPRS) is a self-report scale measuring pain. It is measured from 0 to 10, 0 being pain free and 10 being the worse imaginable pain. This was measured at baseline (T1) and 4 weeks (T2)|4 weeks|||units on a scale||Full Range|Mean
640367|NCT02355275|Primary|Oswestry Disability Index|Patient disability was measured using the Oswestry Disability Index (OSW), a self-report outcome measure. For each section the total possible score is 5: if the first statement is marked the section score = 0; if the last statement is marked, it = 5. The score is calculated by totaling the values marked, divided by 50 x 100. The greater the score the greater the disability. For example, 0% to 20% would be minimal disability and 81%-100% would be bed-bound. This outcome measure was reported at baseline (T1) and 4 weeks later (T2).|4 weeks|||units on a scale||Full Range|Mean
640368|NCT02355158|Primary|Summary of Neuropathic Pain Symptom Inventory (NPSI)|The NPSI is a validated, self-administered questionnaire designed to evaluate the different symptoms of neuropathic pain. Each item is quantified on an 11-point (0-10) numeric scale. The NPSI includes 10 descriptors (plus 2 temporal items) that allow discrimination and quantification of 5 distinct clinically relevant dimensions of neuropathic pain syndromes. The Neuropathic Pain Symptom Inventory (NPSI) is a self-questionnaire designed to evaluate the different symptoms of neuropathic pain, which contains a list of descriptors reflecting spontaneous ongoing or paroxysmal pain, evoked pain (i.e., mechanical and thermal allodynia/hyperalgesia) and dysesthesia/paresthesia. Each of these items is quantified on an 11-point (0-10) numerical scale. NPSI total score was calculated and summarized descriptively at month 12 or the subjects last visit. The total score was calculated and summarized.|Month 12 or last visit|While 197 subjects received study drug, 172 completed the NPSI at the week 12 visit or at their last visit.||units on a scale||Standard Deviation|Mean
640369|NCT02354924|Secondary|Symptoms, Problems and Complaints and Incidence Rate|Subjective Responses to comfort/symptoms/complaints were measured at every visit. 1=Severe Burning to 10=No Burning for each eye|3 month|||eye|eye||Count of Units
664255|NCT01788215|Secondary|Free Testosterone in Serum||week 24|in the sugar till arm, one participant dropped out at week 12||pg/mL||Standard Deviation|Mean
640377|NCT02354599|Secondary|Plasma Total Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) Concentration||Baseline, Hour 24, 72, 120, 168, 240, 336 hours, Day 21, 28, 42, 56, 70, 84|The pharmacodynamic analysis set was defined as all participants who received the study medication without any major protocol deviations, and met the minimum procedure specified in the study protocol and had evaluable pharmacodynamic data.||picogram per milliliter (pg/mL)||Standard Deviation|Mean
640378|NCT02354599|Secondary|Terminal Elimination Half-Life (T1/2) of MT203||Predose and at multiple time points (up to 84 days) post-dose|The pharmacokinetic analysis set as defined as all participants who received the study medication without any major protocol deviations, and met the minimum procedure specified in the study protocol and had evaluable pharmacokinetic data.||day||Full Range|Median
640379|NCT02354599|Secondary|Maximum Observed Serum Concentrations (Cmax) of MT203||Predose and at multiple time points (up to Day 84) post-dose|The pharmacokinetic analysis set as defined as all participants who received the study medication without any major protocol deviations, and met the minimum procedure specified in the study protocol and had evaluable pharmacokinetic data.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
640380|NCT02354599|Secondary|Area Under the Serum Concentration-Time Curve From Time 0 to Time 84 Days (AUC(0-84d)) of MT203||Predose and at multiple time points (up to 84 days) post-dose|The pharmacokinetic analysis set as defined as all participants who received the study medication without any major protocol deviations, and met the minimum procedure specified in the study protocol and had evaluable pharmacokinetic data.||ng*day/mL||Standard Deviation|Mean
640381|NCT02354599|Secondary|Area Under the Serum Concentration-Time Curve From Time 0 to Infinity (AUC(0-inf)) of MT203||Predose and at multiple time points (up to 84 days) post-dose|The pharmacokinetic analysis set as defined as all participants who received the study medication without any major protocol deviations, and met the minimum procedure specified in the study protocol and had evaluable pharmacokinetic data.||nanogram*day per milliliter (ng*day/mL)||Standard Deviation|Mean
640382|NCT02354599|Primary|Number of Participants With TEAEs Related to Hematology, Serum Chemistry and Urinalysis||Baseline up to Day 85|The safety analysis set was defined as all participants who received the study medication.||participants|||Number
640383|NCT02354599|Primary|Number of Participants With TEAEs Related to Lung Functioning Monitoring||Baseline up to Day 85|The safety analysis set was defined as all participants who received the study medication.||participants|||Number
640384|NCT02354599|Primary|Number of Participants With TEAEs Related to 12-lead Electrocardiograms (ECG)||Baseline up to Day 85|The safety analysis set was defined as all participants who received the study medication.||participants|||Number
640385|NCT02354599|Primary|Number of Participants With TEAEs Related to Body Weight||Baseline up to Day 85|The safety analysis set was defined as all participants who received the study medication.||participants|||Number
640386|NCT02354599|Primary|Number of Participants With TEAEs Related to Vital Signs||Baseline up to Day 85|The safety analysis set was defined as all participants who received the study medication.||participants|||Number
640387|NCT02354599|Primary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)||Baseline up to Day 85|The safety analysis set was defined as all participants who received the study medication.||participants|||Number
640388|NCT02353871|Secondary|The Time to Onset of Treatment Response Based on the Subject’s Diary Card.|Median time to onset of treatment response: subjects asked to record their assessment of study treatment response in a diary card on Days 1 to 7. They responded 'yes' or 'no' to the following question: 'since being injected have you noticed an improvement in the appearance of your glabellar lines (lines between your eyebrows)?'|Day 1 to 7|mITT: All randomised subjects who received at least one injection of study treatment into one injection site and who had both Baseline and at least one postbaseline value for the ILA of glabellar lines at maximum frown. One subject from the placebo group was excluded from the analysis due to missing data.||Days||95% Confidence Interval|Median
640389|NCT02353871|Secondary|The Proportion of Responders at Each Post-treatment Visit to the Study Centre as Measured by the Subject’s Level of Satisfaction With the Appearance of Their Glabellar Lines.|"Adjusted proportion of responders at each post-treatment visit (measured by the subject's level of satisfaction with the appearance of their glabellar lines).
4-point categorical scale: Grade 0 - very satisfied; Grade 1 - satisfied; Grade 2 - dissatisfied; Grade 3 - very dissatisfied.
A responder was defined as having a satisfaction rating of very satisfied (Grade 0) or satisfied (Grade 1) at a given visit and a satisfaction rating of dissatisfied (Grade 2) or very dissatisfied (Grade 3) at Baseline (Day 1).
The adjusted proportion of responders in each treatment group was provided using a multivariate logistic regression model."|Day 8, 15, 29, 57, 85, 113, 148 and 183|mITT: All randomised subjects who received at least one injection of study treatment into one injection site and who had both Baseline and at least one postbaseline value for the ILA of glabellar lines at maximum frown. N'=number of subjects with available data at the given visit; P=placebo.||Adjusted percentage of responders||95% Confidence Interval|Number
640390|NCT02353871|Secondary|The Proportion of Responders at Each Post-treatment Visit to the Study Centre as Measured by the Subject's Self-assessment (SSA) at Maximum Frown.|"SSA
4-point photographic scale: No wrinkles - 0; Mild wrinkles - 1; Moderate wrinkles - 2; Severe wrinkles – 3.
A responder at maximum frown was defined as having a severity grade of no wrinkles (Grade 0) or mild wrinkles (Grade 1) at maximum frown at a given visit and a severity grade of moderate wrinkles (Grade 2) or severe wrinkles (Grade 3) at Baseline (Day 1).
The adjusted proportion of responders in each treatment group was provided using a multivariate logistic regression model."|Day 8, 15, 29, 57, 85, 113, 148 and 183|mITT: all randomised subjects who received at least one injection of study treatment into one injection site and who had both Baseline and at least one postbaseline value for the ILA of glabellar lines at maximum frown. N'=number of subjects with available data at the given visit; P=placebo.||Adjusted percentage of responders||95% Confidence Interval|Number
640417|NCT02351934|Secondary|Number of Participants With Hypokalemia|Hypokalemia is generally defined as a serum potassium level of less than 3.5 mmol/L.|Up to 7 days|Intention to treat analysis||Participants|||Count of Participants
640438|NCT02350881|Secondary|Osteolysis|Osteolysis evaluation was described as : absent or present. Radiological evaluations were done from available frontal and lateral view X-rays.|mean 6.9 years (range, 5.5 - 9.5)|Overall cohort||percentage of implants|Participants||Number
640439|NCT02350881|Primary|Pain at Passive Motion of MTP1|Number of patients reporting pain at passive motion of MTP1 at preoperative and postoperative visits.|mean follow-up of 6.9 years (range, 5.2 - 9.5)|Overall cohort||Number of Implants|Participants||Number
640391|NCT02353871|Secondary|The Proportion of Subjects With a Reduction of Two or More Grades in the Severity of Glabellar Lines at Each Post-treatment Visit to the Study Centre as Measured by the ILA at Maximum Frown.|"ILA
4-point photographic scale: None - Grade 0; mild - Grade 1; moderate - Grade 2; severe - Grade 3.
Adjusted proportion of subjects with a reduction of two or more grades in the severity of glabellar lines at each post-treatment visit compared with Baseline.
The adjusted proportion of responders in each treatment group was provided using a multivariate logistic regression model."|Day 8, 15, 29, 57, 85, 113, 148 and 183|mITT: all randomised subjects who received at least one injection of study treatment into one injection site and who had both Baseline and at least one postbaseline value for the ILA of glabellar lines at maximum frown. N'=number of subjects with available data at the given visit; P=placebo.||Adjusted percentage of responders||95% Confidence Interval|Number
640392|NCT02353871|Secondary|The Proportion of Responders at Each Post-treatment Visit to the Study Centre as Measured by the ILA at Rest.|"ILA
4-point photographic scale: None - Grade 0; mild - Grade 1; moderate - Grade 2; severe - Grade 3.
A responder at rest was defined as having a severity grade of none (Grade 0) or mild (Grade 1) at rest at a given visit and a severity grade of moderate (Grade 2) or severe (Grade 3) at Baseline (Day 1).
The adjusted proportion of responders in each treatment group was provided using a multivariate logistic regression model."|Day 8, 15, 29, 57, 85, 113, 148 and 183|mITT: all randomised subjects who received at least one injection of study treatment into one injection site and who had both Baseline and at least one postbaseline value for the ILA of glabellar lines at maximum frown. N'=number of subjects with available data at the given visit.; P=placebo.||Adjusted percentage of responders||95% Confidence Interval|Number
640393|NCT02353871|Secondary|The Proportion of Responders on Day 29 Who Remained Responders on Days 57, 85, 113, 148 and 183 as Measured by the ILA at Maximum Frown.|"ILA
4-point photographic scale: None - Grade 0; mild - Grade 1; moderate - Grade 2; severe - Grade 3.
A responder at maximum frown was defined as having a severity grade of none (Grade 0) or mild (Grade 1) at maximum frown at a given visit and a severity grade of moderate (Grade 2) or severe (Grade 3) at Baseline (Day 1). Subjects who were not responders at Day 29 were excluded from the analysis.
The adjusted proportion of responders in each treatment group was provided using a multivariate logistic regression model."|Day 57, 85, 113, 148 and 183|mITT: All randomised subjects who received at least one injection of study treatment into one injection site and who had both Baseline and at least one postbaseline value for the ILA of glabellar lines at maximum frown. N'=number of subjects with available data at the given visit; P=placebo.||Adjusted percentage of responders||95% Confidence Interval|Number
640394|NCT02353871|Secondary|The Proportion of Responders at Each Post-treatment Visit to the Study Centre (Except Day 29) as Measured by the ILA at Maximum Frown.|"ILA
4-point photographic scale: None - Grade 0; mild - Grade 1; moderate - Grade 2; severe - Grade 3.
A responder at maximum frown was defined as having a severity grade of none (Grade 0) or mild (Grade 1) at maximum frown at a given visit and a severity grade of moderate (Grade 2) or severe (Grade 3) at Baseline (Day 1).
The adjusted proportion of responders in each treatment group was provided using a multivariate logistic regression model."|Day 8, 15, 57, 85, 113, 148 and 183|mITT: all randomised subjects who received at least one injection of study treatment into one injection site and who had both Baseline and at least one postbaseline value for the ILA of glabellar lines at maximum frown. N'=number of subjects with available data at the given visit; P=placebo.||Adjusted percentage of responders||95% Confidence Interval|Number
640395|NCT02353871|Primary|The Proportion of Responders at Day 29 in the ILA of Glabellar Lines at Maximum Frown.|"ILA
4-point photographic scale: None - Grade 0; mild - Grade 1; moderate - Grade 2; severe - Grade 3.
A responder at maximum frown was defined as having a severity grade of none (Grade 0) or mild (Grade 1) at maximum frown on Day 29 and a severity grade of moderate (Grade 2) or severe (Grade 3) at Baseline (Day 1).
The adjusted proportion of responders in each treatment group was provided using a multivariate logistic regression model."|Day 29|Modified intent-to-treat (mITT) population included all randomised subjects who received at least one injection of study treatment into one injection site and who had both Baseline and at least one postbaseline value for the ILA of glabellar lines at maximum frown. Subjects who did not have available data at Day 29 were excluded from the analysis.||Adjusted percentage of responders||95% Confidence Interval|Number
640396|NCT02353754|Secondary|Total Postsurgical Narcotic Consumption in Morphine Equivalents|Outcome measure data refer to 7 participants who received rescue medication|Through 48 hours|||MUEs||Standard Deviation|Mean
640397|NCT02353754|Secondary|Total Postsurgical Narcotic Consumption in Morphine Equivalents|Outcome measure data refer to 6 participants who received rescue medication|Through 24 hours|||MUEs||Standard Deviation|Mean
640398|NCT02353754|Primary|Total Postsurgical Narcotic Consumption in Morphine Equivalents|Outcome measure data refer to 7 participants who received rescue medication|Through 72 hours postdose|||MUEs||Standard Deviation|Mean
640399|NCT02353572|Primary|Maximally Tolerable Dose (MTD) of Both Melphalan and Bortezomib as Combination|MTD is defined as one dose below that which 33% of patients within cohort experienced dose limiting toxicity. Unacceptable toxicity is defined as intractable veno-occlusive disorder, new onset of renal failure requiring dialysis, acute heart failure of New York Heart Association class III/IV, or interstitial pneumonia requiring ventilator management for longer than 3 days or grade 4 neuropathy. A 100-day mortality/toxicity rate of 3% or more is considered unacceptable. Will consider as evidence an observed 100-day mortality/toxicity rate whose lower one-sided 90% confidence bound exceeds 3%.|100 days|The study was terminated, study endpoints were not reached.|||||
640400|NCT02353468|Primary|Event Free Survival Rates by Land-mark Analysis|A Kaplan-Meier curve would have been used to describe the distribution.|up to 5 years|The study was terminated, study endpoints were not reached.|||||
640401|NCT02353442|Secondary|Pain and Function at 4weeks (Pre and Post Treatment)|For these measures, the SPADI (Shoulder Pain and Disabilities Index) questionnaire was used, pre and post treatment. The is a self-assessment questionnaire with 5 questions about pain and 8 about functional activities. The final score (0-100) of the questionnaire is provided in percentage and a maximum score of 100 implies the worst possible condition.|4 weeks: Baseline (pre-treatment), and 4 weeks (post-treatment)|||scores on a scale||Standard Deviation|Mean
640402|NCT02353442|Secondary|Pressure Pain Threshold at 4weeks (Pre and Post Treatment).|It was measured by a digital algometer in kPa pre and post treatment.|4 weeks: Baseline (pre-treatment), and 4 weeks (post-treatment)|||kPa||Standard Deviation|Mean
643875|NCT02226198|Secondary|Non-HDL C/HDL C|Efficacy in terms of non-high density lipoprotein cholesterol (non-HDL C) / HDL C|Samples taken at Day 42 (week 6) and Day 84 (week 12)|||ratio||Standard Deviation|Mean
640406|NCT02352779|Primary|Mean Change (6 Weeks - Baseline) and Standard Deviation in Cancer-related Fatigue, Using the Brief Fatigue Inventory-Short Form (BFI-SF) and Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF). 81 Subjects Had Both a Baseline and 6 Week Value|"BFI-SF is a 4 item questionnaire to assess the severity of fatigue, ranging from 0 (No Fatigue) to 10 (As bad as you can imagine).
MFSI-SF is a 30 item questionnaire to assess the level of fatigue in terms of general fatigue, physical fatigue, emotional fatigue, mental fatigue, and vigor). First four subscales (general, physical, emotional, and mental) are summed and the vigor scale is subtracted to create fatigue total score with a range of -32 (low fatigue) to 96 (high fatigue)."|Baseline to 6 weeks|||units on a scale||95% Confidence Interval|Least Squares Mean
640407|NCT02352298|Primary|Dario Blood Glucose Monitoring System Accuracy at High Altitude (ISO 15197:2003)|Accuracy of Dario Blood Glucose Monitoring System when compared to Yellow Springs Instrument 2300 reference method at 10,152 feet above sea level. Acceptance criteria set per (International Organization for Standardization) ISO 15197:2003. Greater than or equal to 95% of the Dario results shall fall within plus or minus 15 mg/dL of the reference method value (for glucose concentrations <75 mg/dL). For glucose concentrations greater than or equal to 75 mg/dL, the Dario results shall fall within plus or minus 20% of the reference method value.|6 seconds|||percentage of participants|||Number
640408|NCT02351960|Secondary|Percentage of Participants in the EE Group Who Had Endoscopically Evaluated Macroscopic Healing of Their Esophagus|Participants underwent endoscopy to determine the percentage of participants with macroscopic healing of their esophagus showing at least 1 Los Angeles (LA) grade classification grade improvement at week 8. Endoscopic findings classified according to the Los Angeles classification: Grade Normal - endoscopy reveals no mucosal break Grade A- one or more mucosal breaks <5 mm in maximal length Grade B - one or more mucosal breaks >5 mm, but without continuity across mucosal folds Grade C - Mucosal breaks continuous between >2 mucosal folds, but involving less than 75% of the esophageal circumference Grade D - Mucosal breaks involving more than 75% of the esophageal circumference.|Week 8|FAS included all participants who received at least 1 dose of study drug and had post-baseline data for the appropriate efficacy variable.||percentage of participants|||Number
640409|NCT02351960|Secondary|Number of Participants With Severity of Gastroesophageal Reflux Disease (GERD) Symptoms|The severity of participants' GERD symptoms based on the investigator's assessment among all participants was evaluated at Week 4 or Week 8. GERD symptoms were assessed on a 5-point scale, wherein 1=no symptom, 2=mild, 3=moderate, 4=severe and 5=very severe. GERD symptoms include heartburn (HB), acid regurgitation (AR), dysphagia (dysp), belching (bch) and epigastric pain (EP).|Up to 4 weeks for NERD participants and up to 8 weeks for EE participants|FAS included all participants who received at least 1 dose of study drug and had post-baseline data for the appropriate efficacy variable. Here, 'n' is the number of participants who were analyzed for GERD assessments at specified time points.||participants|||Number
640410|NCT02351960|Secondary|Percentage of Nights (Participant Sleep Time) Without Nighttime Acid Regurgitation|Participants were asked to keep a daily paper diary. The percentage of nights without nighttime acid regurgitation in both the group was assessed by participant diary entries.|Up to 4 weeks for NERD participants and up to 8 weeks for EE participants|FAS included all participants who received at least 1 dose of study drug and had post-baseline data for the appropriate efficacy variable. Here number of participants analyzed are the participants who were evaluable for this outcome measure.||percentage of nights||Full Range|Median
640411|NCT02351960|Secondary|Percentage of Nights (Participant Sleep Time) Without Nighttime Heartburn|Participants were asked to keep a daily paper diary. The percentage of nights without nighttime heartburn in both the group was assessed by participant diary entries.|Up to 4 weeks for NERD participants and up to 8 weeks for EE participants|FAS included all participants who received at least 1 dose of study drug and had post-baseline data for the appropriate efficacy variable. Here number of participants analyzed are the participants who were evaluable for this outcome measure.||percentage of nights||Full Range|Median
640412|NCT02351960|Secondary|Percentage of Nights (Participant Sleep Time) Without Nighttime Heartburn and Acid Regurgitation|Participants were asked to keep a daily paper diary. The percentage of nights without nighttime heartburn and acid regurgitation in both the group was assessed by participant dairy entries.|Up to 4 weeks for NERD participants and up to 8 weeks for EE participants|FAS included all participants who received at least 1 dose of study drug and had post-baseline data for the appropriate efficacy variable. Here number of participants analyzed are the participants who were evaluable for this outcome measure.||percentage of nights||Full Range|Median
640413|NCT02351960|Secondary|Percentage of 24-hour Acid Regurgitation-free Days|Participants were asked to keep a daily paper diary. The percentage of 24-hour acid regurgitation-free days following study drug treatments was assessed by participant's diary entries.|Up to 4 weeks for NERD participants and up to 8 weeks for EE participants|FAS included all participants who received at least 1 dose of study drug and had post-baseline data for the appropriate efficacy variable. Here number of participants analyzed are the participants who were evaluable for this outcome measure.||percentage of days||Full Range|Median
640414|NCT02351960|Secondary|Percentage of 24-hour Heartburn-free Days|Participants were asked to keep a daily paper diary. The percentage of 24-hour heartburn free days following study drug treatments was assessed by the participant diary entries.|Up to 4 weeks for NERD participants and up to 8 weeks for EE participants|FAS included all participants who received at least 1 dose of study drug and had post-baseline data for the appropriate efficacy variable. Here number of participants analyzed are the participants who were evaluable for this outcome measure.||percentage of days||Full Range|Median
640415|NCT02351960|Primary|Percentage of 24-Hour Heartburn and Acid Regurgitation-Free Days in Erosive Esophagitis (EE) Participants|EE participants were asked to keep a paper diary of daily heartburn and acid regurgitation-free days and the percentage of heartburn and acid regurgitation-free days was calculated.|Up to Week 8|FAS included all participants who received at least 1 dose of study drug and had post-baseline data for the appropriate efficacy variable. Here number of participants analyzed are the participants who were evaluable for this outcome measure.||percentage of days||Full Range|Median
640416|NCT02351960|Primary|Percentage of 24-Hour Heartburn and Acid Regurgitation-Free Days in Non-Erosive Reflux Disease (NERD) Participants|NERD participants were asked to keep a paper diary of daily heartburn and acid regurgitation-free days and the percentage of heartburn and acid regurgitation-free days was recorded.|Up to Week 4|Full analysis set (FAS) included all participants who received at least 1 dose of study drug and had post-baseline data for the appropriate efficacy variable.||percentage of days||Full Range|Median
640418|NCT02351934|Secondary|Number of Participants With Acute Kidney Injury|Acute kidney injury (AKI) refers to an abrupt decrease in kidney function, resulting in the retention of urea and other nitrogenous waste products and in the dysregulation of extracellular volume and electrolytes. The term AKI has largely replaced acute renal failure (ARF), reflecting the recognition that smaller decrements in kidney function that do not result in overt organ failure are of substantial clinical relevance and are associated with increased morbidity and mortality. The AKI experienced by these patients was not considered an adverse event.|Up to 7 days|Intention to treat analysis||Participants|||Count of Participants
640419|NCT02351934|Secondary|Time to Stool Output||Up to 4 days|Intention to treat analysis||hours||Inter-Quartile Range|Median
640420|NCT02351934|Secondary|Number of Participants Requiring Nasogastric Tube Placement||Up to 7 days|Intention to Treat Analysis||Participants|||Count of Participants
640421|NCT02351934|Secondary|Number of Participants Readmitted to Mayo Clinic Within 30-days||Within 30 days of release from hospital|Intention to treat analysis||Participants|||Count of Participants
640422|NCT02351934|Primary|Length of Hospital Stay|Participants will be followed for the duration of hospital stay, an expected average of 2-7 days.|Up to 7 days|Intent to treat analysis||hours||Inter-Quartile Range|Median
640423|NCT02351817|Primary|Product Acceptance|"Product acceptance was measurement qualitatively by interviews exploring the factors and mechanisms affecting the acceptance. The interview questions were formulated in such a way that was not possible to quantify the number of subjects accepting the test products.
There were problems with test product performance and handling and therefore the acceptance of the products was not high. Product preference was secondary endpoint, where the subjects were asked whether they preffered their own product over the test products. This endpoint is the best measure we have for mimiking product acceptance. However, we are aware subjects could accept a product without preferring it over own product and the preferrence result might therefore not be accurate.
The result presented below shows how many subjects preferred Test A/Test B over own product"|7 days per test period|One subject did not answer the preference question.||participants|||Number
640424|NCT02351505|Secondary|Proportion of Patients Who go Off Treatment Due to Adverse Reactions or Even Those Who Refuse Further Treatment for Lesser Toxicities That Inhibit Their Willingness to Continue Participation on the Trial||Up to 4 years|Unable to analyze data due to only 1 patient being enrolled on the study|||||
640425|NCT02351505|Secondary|Tolerability of the Regimen Assessed Through Number of Patients Who Required Dose Modifications and/or Dose Delays||Up to 4 years|Unable to analyze data due to only 1 patient being enrolled on the study|||||
640426|NCT02351505|Secondary|Incidence of Severe (Grade 3+) Adverse Events or Toxicities as Per NCI CTCAE v4.0|The incidence of severe (grade 3+) adverse events or toxicities will be described.|Up to 4 years|||percentage of patients|||Number
640427|NCT02351505|Secondary|Frequency of Adverse Events Defined as Adverse Events That Are Classified as Either Not Related, Possibly, Probably, or Definitely Related to Study Treatment as Per NCI CTCAE v4.0|Summarized by descriptive statistics for each of the disease cohorts. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns. In addition, review all adverse event data that is graded as 3, 4, or 5 and classified as either “unrelated” or “unlikely to be related” to study treatment in the event of an actual relationship developing.|Up to 4 years|Unable to analyze data due to only 1 patient being enrolled on the study|||||
640428|NCT02351505|Secondary|Overall Survival|Kaplan-Meier curves will be used to estimate overall survival. Consider Cox proportional hazards models to explore a limited set of confounding factors.|Date of study registration to the date of event (i.e., death) or the date of last follow-up if no event has occurred at their last evaluation assessed up to 4 years|Unable to analyze data due to only 1 patient being enrolled on the study|||||
640429|NCT02351505|Secondary|Disease Control Rate (CR, PR, and Stable Disease)|Estimates will be accompanied by exact binomial confidence intervals.|Up to 4 years|Unable to analyze data due to only 1 patient being enrolled on the study|||||
640430|NCT02351505|Secondary|Objective Response Rate (Complete Response [CR] or Partial Response [PR]) by RECIST|The overall response rate will be calculated as the number of PRs and CRs divided by the total number of evaluable patients. Estimates will be accompanied by exact binomial confidence intervals as well.|Up to 4 years|Unable to analyze data due to only 1 patient being enrolled on the study|||||
640431|NCT02351505|Primary|Progression Free Survival|Estimated by the method of Kaplan and Meier for each cohort. Appropriate one-sided 90% confidence boundary will also be calculated for the final test Kaplan–Meyer test statistic at 12 weeks.|Time from the date of study registration to the date of disease progression or to the date of last observation when no event (disease progression) has occurred, assessed up to 4 years|Unable to analyze data due to only 1 patient being enrolled on the study|||||
640432|NCT02350881|Secondary|Survival of the Implant.|The survival of the implant is evaluated according to the number of implant revisions or of reoperations, whatever the reason.|mean follow-up of 6.9 years (range, 5.2 - 9.5)|Overall cohort||percentage of implants|Participants||Number
640433|NCT02350881|Primary|Pain at Rest|"Subjective evaluation of patients about ther pain at rest, postoperatively versus preoperatively. Patients had to choose among 4 variables : disappeared, less, same, greater."|mean follow-up of 6.9 years (range, 5.2 - 9.5)|Overall cohort||Number of Implants|Participants||Number
640434|NCT02350881|Primary|Pain During Walking|"Subjective evaluation by patients about pain during walking, postoperatively versus preoperatively. Patients had to choose among 4 variables : disappeared, less, same, greater."|mean follow-up of 6.9 years (range, 5.2 - 9.5)|Overall cohort||Number of Implants|Participants||Number
640435|NCT02350881|Primary|Walking Perimeter|"Subjective evaluation by the patients of their walking perimeter, postoperatively versus preoperatively. Patient had to choose among 3 variables : improved, same, worsened."|mean follow-up of 6.9 years (range, 5.2 - 9.5)|Overall cohort||Number of Implants|Participants||Number
640436|NCT02350881|Primary|Pain at Pressure of MTP1|Number of patients reporting pain at pressure of MTP1 at preoperative and postoperative visits.|mean follow-up of 6.9 years (range, 5.2 - 9.5)|Overall cohort||Number of Implants|Participants||Number
640437|NCT02350881|Secondary|Bone Resorption|Bone resorption evaluation was described as : absent or present. Radiological evaluations were performed from available frontal and lateral view X-rays.|mean 6.9 years (range, 5.5 - 9.5)|Overall cohort||percentage of implants|Participants||Number
664256|NCT01788215|Secondary|Free Testosterone in Serum||week 12|||pg/mL||Standard Deviation|Mean
640440|NCT02350881|Primary|AOFAS Hallux-MTP-IP - PAIN Score|Pain is a sub-score of the AOFAS Hallux-MTP-IP score and is measured on a scale of 40 points - the higher value represents a minimal pain.|mean follow-up of 6.9 years (range, 5.2 - 9.5)|Overall cohort||units on a scale|Participants|Standard Deviation|Mean
640441|NCT02350881|Primary|AOFAS Hallux-MTP-IP Score - Overall|"AOFAS (American Orthopedic Foot and Ankle Society) Hallux-MTP-IP (Hallux-Meta-Tarso-Phalangeal-Inter-Phalangeal) score is composed of 3 sub-scores : (i) Pain score is ranging from 0 to 40 points ; Function score is ranging from 0 to 45 points ; Alignment is ranging from 0 to 15 points. The AOFAS total score is then ranging from 0 to 100 points. A result over 80 points is considered good, below 20 points as bad."|mean 6.9 years follow-up (range 5.2 - 9.5)|number of implants analyzed (70 implants in 64 patients)||units on a scale|Participants|Standard Deviation|Mean
640442|NCT02350569|Secondary|Percentage of Participants With HCV RNA < LLOQ While on Treatment at Days 1, 3, 5, 7, 14, 21, and 28||Days 1, 3, 5, 7, 14, 21, and 28|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants||95% Confidence Interval|Number
640443|NCT02350569|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as:
End of treatment virologic failure:
Completed 28 days LDV/SOF treatment and had HCV RNA ≥ LLOQ at last measurement on treatment
Virologic relapse:
Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment HCV RNA measurement."|Up to Posttreatment Week 12|Full Analysis Set: participants who were enrolled into the study, received a liver transplant while on study, and received at least 1 dose of study drug||percentage of participants|||Number
640444|NCT02350569|Secondary|Percentage of Participants With SVR 4 Weeks After Discontinuation of Therapy (SVR4)|SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.|Posttreatment Week 4|Full Analysis Set: participants who were enrolled into the study, received a liver transplant while on study, and received at least 1 dose of study drug||percentage of participants||95% Confidence Interval|Number
640445|NCT02350569|Primary|Percentage of Participants Who Prematurely Discontinued Study Drug Due to an Adverse Event||Up to 4 weeks|Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug||percentage of participants|||Number
640446|NCT02350569|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants who were enrolled into the study, received a liver transplant while on study, and received at least 1 dose of study drug||percentage of participants||95% Confidence Interval|Number
640447|NCT02349711|Secondary|Regulatory T Cells (Tregs)|Regulatory T cells (Tregs) as a percentage of CD4+ T cells, quantified via flow cytometry|baseline and week 6|A subgroup of participants who completed the main study (questionnaire data only) also completed an additional portion of the study in which they provided blood and stool samples. Some samples could not be accurately measured for this outcome, so those samples were excluded from analysis.||percentage of CD4+ T lymphocytes||Standard Error|Least Squares Mean
640448|NCT02349711|Secondary|Constipation Symptom Score, Measured by Gastrointestinal Symptom Response Scale (GSRS) Questionnaire|Symptoms included in this score are constipation, hard stools, and feeling of incomplete evacuation reported on a weekly Gastrointestinal Symptom Response Scale (GSRS) questionnaire. Questionnaire asks participants about the previous seven days. Scores range from 1 (no discomfort) to 7 (very severe discomfort); lower scores are more desirable.|weeks 0, 1, 2, 3, 4, 5, 6, 7|Since this outcome had more than two time points, and since all randomized participants provided some weeks of survey data, all participants were included in the analysis (even those that were lost to follow up). The number of values (and thus the number analyzed) by week is also shown.||units on a scale||Standard Error|Mean
640449|NCT02349711|Secondary|Serum Total Immunoglobulin E (IgE)|Serum total immunoglobulin E (IgE) was quantified via ELISA|baseline and week 6|A subgroup of participants who completed the main study (questionnaire data only) also completed an additional portion of the study in which they provided blood and stool samples.||ng/mL||Standard Error|Mean
640450|NCT02349711|Primary|Change in Health-related Quality of Life Score From Baseline to the Peak Week of Allergy Season for Probiotic Versus Placebo, as Measured by MiniRQLQ|MiniRQLQ, global score (0=not troubled, 6=extremely troubled; an average of the 14 questions; includes all domains)|up to 8 weeks from date of randomization|"Because this was an intent-to-treat study, all data from all randomized participants was considered for analysis. No imputation was done, so missing values excluded a participant from the analysis. While data from a participant may be missing, they were considered to have completed the study if they completed all study visits."||units on a scale||Standard Error|Least Squares Mean
640451|NCT02349685|Secondary|Number of Participants in Each Arm/Group With Successful H. Pylori Eradication|"the efficacy of H. pylori eradication between a personalized therapy for H. pylori infection based on the results of antibiotics resistance by using H. pylori culture and minimal inhibitory concentration (MIC) and the traditional 2nd rescue regimens.
The eradication rate was evaluated by per-protocol analysis (PP)"|6 weeks after completion of eradication|||participants|||Number
640452|NCT02349685|Primary|Number of Participants in Each Arm/Group With Successful H. Pylori Eradication|"the efficacy of H. pylori eradication between a personalized therapy for H. pylori infection based on the results of antibiotics resistance by using H. pylori culture and minimal inhibitory concentration (MIC) and the traditional 2nd rescue regimens.
The eradication rate was evaluated by intention to treat (ITT)"|6 weeks after completion of eradication|||participants|||Number
640453|NCT02349542|Secondary|Plasma Bupivacaine Levels|Blood samples will be drawn and analyzed to establish levels of bupivacaine detectable in the blood. Blood samples will be drawn at baseline (prior to injection), upon injection, at 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours post-injection and analyzed to determine levels of bupivacaine present.|Up to 72 hours following injection|Blood draws were collected at the pre-defined intervals unless the patient was discharged prior to the blood collection time. 6 patients were discharged prior to the 48 hour collection time. 5 additional patients were discharged prior to the 72 hour collection time.||ug/ml||Standard Deviation|Mean
640454|NCT02349542|Primary|Adverse Events|Number of Participants with Adverse Events|Up to 72 hours following injection|||participants|||Number
641023|NCT02322892|Other Pre-specified|Cellular Oxygen Consumption|Cellular (peripheral blood mononuclear cells) oxygen consumption measured with the XFe24 Extracellular Flux Analyzers|Post-surgery within 1 hour of arrival to the ICU||||||
640455|NCT02349451|Secondary|Change From Baseline in Psoriasis Target Lesion Score at Week 12|Target lesion score for psoriasis in participants with psoriatic arthritis is calculated by adding the scores of plaque erythema, scaling and thickness. Scores range from 0 (no erythema or evidence of plaque thickness) to 10 (severe erythema and evidence of plaque thickness).|Baseline, Week 12|Full Analysis Set: all randomized participants who received at least 1 dose of study drug. LOCF: missing responses are imputed by calculation based on the last non-missing post-baseline component values.||units on a scale||95% Confidence Interval|Least Squares Mean
640456|NCT02349451|Secondary|Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Week 12|PASDAS is a continuous compound disease activity state score determined by the combined values of tender or swollen joint counts, participant-reported outcome and hsCRP lab test. The PASDAS is unitless, with a typical score range between 0 and 10. Smaller values on PASDAS indicate a better condition; a negative change from baseline indicates improvement.|Baseline, Week 12|Full Analysis Set: all randomized participants who received at least 1 dose of study drug. LOCF: missing responses are imputed by calculation based on the last non-missing post-baseline component values.||units on a scale||95% Confidence Interval|Least Squares Mean
640457|NCT02349451|Secondary|Change From Baseline in Disease Activity Score 28 (DAS28[hsCRP]) at Week 12|The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10, with higher scores indicating more disease activity.|Baseline, Week 12|Full Analysis Set: all randomized participants who received at least 1 dose of study drug. LOCF: missing responses are imputed by calculation based on the last non-missing post-baseline component values.||units on a scale||95% Confidence Interval|Least Squares Mean
640458|NCT02349451|Secondary|ACRn at Week 12|ACR measures percentage improvements in tender and swollen joint counts, patient assessments of pain, global disease activity and physical function, physician global assessment of disease activity and acute phase reactant. ACRn is a continuous variable based on the ACR criteria. Improvement from baseline in a component of the ACR composite variable was computed as the difference between the baseline value and the value at a given post-baseline visit. A positive value for improvement from baseline for an individual component indicates lesser severity of disease. The 95% confidence interval for mean is constructed using T-statistic with significance level alpha=5%.|At Week 12|Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Last observation carried forward (LOCF): missing responses are imputed by calculation based on the last non-missing post-baseline component values.||percentage improvement||95% Confidence Interval|Mean
640459|NCT02349451|Secondary|ACR70 Response Rate at Week 12|Percentage of participants with an ACR70 response, defined as at least 70% improvement (compared to baseline values) in tender and swollen joint counts and at least 70% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function and acute phase reactant hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agresti-Coull method.|Week 12|Full Analysis Set: all randomized participants who received at least 1 dose of study drug. NRI: missing responses are imputed as non-responders.||percentage of participants||95% Confidence Interval|Number
640460|NCT02349451|Secondary|ACR50 Response Rate at Week 12|Percentage of participants with an ACR50 response, defined as at least 50% improvement (compared to baseline values) in tender and swollen joint counts and at least 50% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function and acute phase reactant hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agresti-Coull method.|Week 12|Full Analysis Set: all randomized participants who received at least 1 dose of study drug. NRI: missing responses are imputed as non-responders.||percentage of participants||95% Confidence Interval|Number
640461|NCT02349451|Secondary|ACR20 Response Rate at Week 12: ABT-122 Versus Adalimumab|Percentage of participants with an ACR20 response, defined as at least 20% improvement (compared to baseline values) in tender and swollen joint counts and at least 20% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function and acute phase reactant hsCRP). Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agresti-Coull method.|Week 12|Full Analysis Set: all randomized participants who received at least 1 dose of study drug. NRI: missing responses are imputed as non-responders.||percentage of participants||95% Confidence Interval|Number
640462|NCT02349451|Primary|American College of Rheumatology (ACR) 20 Response Rate at Week 12: ABT-122 Versus Placebo|Percentage of participants with an ACR20 response, defined as at least 20% improvement (compared to baseline values) in tender and swollen joint counts and at least 20% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function and acute phase reactant high sensitivity C-reactive protein [hsCRP]). Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agresti-Coull method.|Week 12|Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Non-responder imputation (NRI): missing responses are imputed as non-responders.||percentage of participants||95% Confidence Interval|Number
640463|NCT02349438|Primary|Higher Order Root Mean Square (HO RMS) - Distance Target in Primary Gaze With Controlled Blink|Wavefront metric measured by COAS wavefront sensor while subject fixates a distant target in primary gaze with controlled blinking. The average HO RMS was reported for each lens. Lower values indicate better outcome.|2 hours post insertion|All subjects that have completed all study visits.||microns||Standard Deviation|Mean
640464|NCT02349438|Primary|Higher Order Root Mean Square (HO RMS) - Near Target in Downgaze With Controlled Blink|Wavefront metric measured by COAS wavefront sensor while subject fixates a near digital device in a down-gaze position with controlled blinking. The average HO RMS was reported for each lens. Lower values indicate better outcome.|2 hours post insertion|All subjects that have completed all study visits.||microns||Standard Deviation|Mean
641024|NCT02322892|Other Pre-specified|Global Oxygen Consumption (VO2)|VO2 will be measured with a Compact Anesthesia monitor|From arrival to ICU to extubation, limit 6 hours||||||
640465|NCT02349438|Primary|Higher Order Root Mean Square (HO RMS) - Near Target in Downgaze With Natural Blinking|Wavefront metric measured by COAS wavefront sensor while subject fixates a near digital device in a down-gaze position with natural blinking. The average HO RMS was reported for each lens. Lower values indicate better outcome.|2 hours post insertion|All subjects that have completed all study visits.||microns||Standard Deviation|Mean
640466|NCT02349048|Secondary|Percentage of Participants With or Without an NS3 Q80K Polymorphism at Baseline Achieving SVR|The Q80K polymorphism, associated with low level SMV in vitro resistance. Percentage of participants who achieved SVR with or without an NS3 Q80K polymorphism at baseline were reported.|up to Week 30 for Arm A and Week 32 for Arm B|The ITT analysis set is defined as all enrolled participants who took at least 1 dose of SMV, SOF or DCV. Here, N (number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' signifies number of participants evaluable for this outcome measure at specific time point.||Percentage of Participants|||Number
640467|NCT02349048|Secondary|Number of Participants With HCV Nonstructural Protein 3/4A (NS3/4A), NS5A and NS5B Sequence in Participants Not Achieving SVR|Sequencing of the HCV nonstructural protein 3/4A (NS3/4A), nonstructural protein 5A (NS5A) and nonstructural protein 5B (NS5B) genes was done to identify preexisting sequence polymorphisms and characterize emerging HCV viral variants in participants not achieving SVR.|Up to Week 30 for Arm A and up to Week 32 for Arm B|The Intent-to-treat (ITT) analysis set is defined as all enrolled participants who took at least 1 dose of Simeprevir (SMV), Sofosbuvir (SOF) or Daclatasvir (DCV).||Participants|||Number
640468|NCT02349048|Secondary|Number of Participants With Late Viral Relapse|Late Viral Relapse: Participant who achieved SVR12 and the post treatment HCV RNA measurement fulfilled 1 the following conditions: a) at least 2 consecutive measurements not lesser than (<)15 IU/mL undetectable, of which at least the second measurement was >=15 IU/mL quantifiable or b) the last available measurement was >=15 IU/mL quantifiable.|From Week 18 to Week 30 (for Arm A), From Week 20 to Week 32 (for Arm B)|The Intent-to-treat (ITT) analysis set is defined as all enrolled participants who took at least 1 dose of Simeprevir (SMV), Sofosbuvir (SOF) or Daclatasvir (DCV).||Participants|||Number
640469|NCT02349048|Secondary|Number of Participants With Viral Relapse|Viral Relapse: Participants who did not achieve SVR12, with undetectable HCV RNA at the actual end of study drug treatment and confirmed HCV RNA greater than or equal to (>=) LLOQ during followup.|From Week 6 to Week 18 (for Arm A) and From Week 8 to Week 20 (for Arm B)|The Intent-to-treat (ITT) analysis set is defined as all enrolled participants who took at least 1 dose of Simeprevir (SMV), Sofosbuvir (SOF) or Daclatasvir (DCV).||Participants|||Number
640470|NCT02349048|Secondary|Percentage of Participants With On-Treatment Failure|Participants who did not achieve SVR12 and with confirmed detectable HCV RNA at the actual end of treatment. Includes participants with: 1) viral breakthrough, defined as a confirmed increase of greater than (>)1 log10 in HCV RNA from nadir, or confirmed HCV RNA 2) confirmed detectable HCV RNA at the actual end of treatment (example, completed treatment, discontinued due to adverse events, withdrawal of consent) of >100 IU/mL in participants whose HCV RNA had previously been <LLOQ while on treatment.|Baseline up to End of Treatment (Week 6 for Arm A and Week 8 for Arm B)|The Intent-to-treat (ITT) analysis set is defined as all enrolled participants who took at least 1 dose of Simeprevir (SMV), Sofosbuvir (SOF) or Daclatasvir (DCV).||Percentage of Participants|||Number
640471|NCT02349048|Secondary|Percentage of Participants With Sustained Virologic Response at 4 Weeks (SVR4) and 24 Weeks (SVR24) After End of Study Drug Treatment|Participants were considered to have achieved SVR4 and SVR24 if the HCV RNA was <LLOQ detectable or undetectable at 4 weeks and 24 weeks respectively after the end of study drug treatment. The LLOQ value was 15 IU/mL.|4 weeks after end of study drug treatment (week 10 for Arm A and 12 for Arm B); 24 weeks after end of study drug treatment (week 30 for Arm A and 32 for Arm B)|The Intent-to-treat (ITT) analysis set is defined as all enrolled participants who took at least 1 dose of Simeprevir (SMV), Sofosbuvir (SOF) or Daclatasvir (DCV).||Percentage of Participants|||Number
640472|NCT02349048|Secondary|Percentage of Participants With On-treatment Virologic Response|"On-treatment virologic response was determined by hepatitis C virus (HCV) ribonucleic acid (RNA) results satisfying a specified threshold.
The following thresholds were considered at any time point: <LLOQ undetectable, <LLOQ detectable, and <LLOQ undetectable or detectable. The LLOQ value was 15 IU/mL. Very rapid virologic response (vRVR) is undetectable HCV RNA at Week 2 while on treatment and Rapid virologic response (RVR) is undetectable HCV RNA at Week 4 while on treatment."|Day 2, Day 3, Week 1, 2, 3, 4, 6 (for Arm A) and 8 (for Arm B only)|The Intent-to-treat (ITT) analysis set is defined as all enrolled participants who took at least 1 dose of Simeprevir (SMV), Sofosbuvir (SOF) or Daclatasvir (DCV). Here 'n' signifies number of participants who were evaluable at each specified time point, for each arm, respectively.||Percentage of Participants|||Number
640473|NCT02349048|Primary|Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After End of Study Drug Treatment (SVR12)|Participants were considered to have achieved SVR12 if the hepatitis C virus ribonucleic acid (HCV RNA) was less than (<) lower limit of quantification (LLOQ; 15 international unit per milliliter [IU/mL]) detectable or undetectable at 12 weeks after the end of study drug treatment.|12 weeks after end of study drug treatment (week 18 for Arm A and week 20 for Arm B)|The Intent-to-treat (ITT) analysis set is defined as all enrolled participants who took at least 1 dose of Simeprevir (SMV), Sofosbuvir (SOF) or Daclatasvir (DCV).||Percentage of Participants|||Number
640474|NCT02348658|Secondary|Number of Participants With Clinical Significant Findings in Electrocardiograms After Study Drug Administration|Participants whose results of electrocardiograms were judged as abnormal and clinically significant by investigator after study drug administration were counted in this measurement.|Baseline up to 14 days after last dose of study drug (14 days after Day 1 of Period 2 )|Safety analysis set included all participants who received the study drug.||participants|||Number
640475|NCT02348658|Secondary|Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Laboratory Values||Baseline up to 14 days after last dose of study drug (14 days after Day 1 of Period 2 )|Safety analysis set included all participants who received the study drug.||participants|||Number
640476|NCT02348658|Secondary|Number of Participants With TEAEs Related to Body Weight||Baseline up to 14 days after last dose of study drug (14 days after Day 1 of Period 2 )|Safety analysis set included all participants who received the study drug.||participants|||Number
640477|NCT02348658|Secondary|Number of Participants With TEAEs Related to Vital Signs||Baseline up to 14 days after last dose of study drug (14 days after Day 1 of Period 2 )|Safety analysis set included all participants who received the study drug.||participants|||Number
640478|NCT02348658|Secondary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)||Baseline up to 14 days after last dose of study drug (14 days after Day 1 of Period 2 )|Safety analysis set included all participants who received the study drug.||participants|||Number
640479|NCT02348658|Primary|Urinary Excretion Ratio of AML|Urinary excretion ratio (% of dose) of AML in urine were calculated for each participant. Ratio was calculated from the urine concentrations of each analyte and the volume of urine collected in each pooling period.|Day 1: predose and at multiple time-points (up to 120 hours) postdose in each period|PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and who were evaluable for the food-effect.||percentage of dose|||Number
640480|NCT02348658|Primary|Urinary Excretion Ratio of TAK-536, Its Metabolites (M-I and M-II) and HCTZ|Urinary excretion ratio (percent [%] of dose) of TAK-536, its metabolite M-I, M-II and HCTZ in urine were calculated for each participant. Ratio was calculated from the urine concentrations of each analyte and the volume of urine collected in each pooling period.|Day 1: predose and at multiple time-points (up to 48 hours) postdose in each period|PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and who were evaluable for the food-effect.||percentage of dose|||Number
640481|NCT02348658|Primary|AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for AML|AUC (0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.|Day 1: predose and at multiple time points (up to 120 hours) postdose in each period|PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and who were evaluable for the food-effect.||ng*hr/mL||Standard Deviation|Mean
640482|NCT02348658|Primary|AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity in Each Period for TAK-536, Its Metabolites (M-I and M-II) and HCTZ|AUC (0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.|Day 1: predose and at multiple time points (up to 48 hours) postdose in each period|PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and who were evaluable for the food-effect.||ng*hr/mL||Standard Deviation|Mean
640483|NCT02348658|Primary|AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration in Each Period for AML|AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]).|Day 1: predose and at multiple time points (up to 120 hours) postdose in each period|PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and who were evaluable for the food-effect.||ng*hr/mL||Standard Deviation|Mean
640484|NCT02348658|Primary|AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration in Each Period for TAK-536, Its Metabolites (M-I and M-II) and HCTZ|AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]).|Day 1: predose and at multiple time points (up to 48 hours) postdose in each period|PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and who were evaluable for the food-effect.||ng*hr/mL||Standard Deviation|Mean
640485|NCT02348658|Primary|AUC(0-120): Area Under the Plasma Concentration-Time Curve From Time 0 to 120 Hours Postdose in Each Period for AML|AUC(0-120) is a measure of the area under the plasma concentration time-curve from time 0 to 120 hours postdose.|Day 1: predose and at multiple time points (up to 120 hours) postdose in each period|PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and who were evaluable for the food-effect.||ng*hr/mL||Standard Deviation|Mean
640486|NCT02348658|Primary|AUC(0-48): Area Under the Plasma Concentration-Time Curve From Time 0 to 48 Hours Postdose in Each Period for TAK-536, Its Metabolites (M-I and M-II) and HCTZ|AUC(0-48) is a measure of the area under the plasma concentration time-curve from time 0 to 48 hours postdose.|Day 1: predose and at multiple time points (up to 48 hours) postdose in each period|PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and who were evaluable for the food-effect.||nanogram*hour per milliliter (ng*hr/mL)||Standard Deviation|Mean
640487|NCT02348658|Primary|Cmax: Maximum Plasma Concentration for Amlodipine Besilate (AML)||Day 1: predose and at multiple time points (up to 120 hours) postdose in each period|PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and who were evaluable for the food-effect.||ng/mL||Standard Deviation|Mean
640488|NCT02348658|Primary|Cmax: Maximum Plasma Concentration for TAK-536, Its Metabolites (M-I and M-II) and Hydrochlorothiazide (HCTZ)||Day 1: predose and at multiple time points (up to 48 hours) postdose in each period|Pharmacokinetic (PK) analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and who were evaluable for the food-effect.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
640489|NCT02347488|Secondary|Potentially High Extubation Risk|Number of participants experiencing ETT movement >4cm under each fixation technique|5 minutes after intubation (which occurs at the very beginning of the anesthesia about 2-5 minutes after the patient goes to sleep)|||Participants|||Count of Participants
640490|NCT02347488|Secondary|Clinically Significant Movement|Number of participants experiencing ETT movement >1cm under each fixation technique|5 minutes after intubation (which occurs at the very beginning of the anesthesia about 2-5 minutes after the patient goes to sleep)|||Participants|||Count of Participants
640491|NCT02347488|Secondary|Participants With Irritation or Minor Injury to the Face and Oral Structures Likely Attributable to the Study Device|The patients were examined after surgery (both immediately after surgery and at the end of the recovery room period) to determine if the patient suffered any irritation or minor injury to the face and oral structures. The patients were asked to fill out a questionnaire after recovery with questions about their overall experience with specific relation to any irritation and/or minor trauma to their face, oral structures, throat, jaw, and temporomandibular joint.|Immediately after surgery and 1-3 days following surgery, before discharge.|29 patients returned the survey (one patient was aphasic post-op and could not compete the survey)||Participants|||Count of Participants
640492|NCT02347488|Primary|Change in ETT Position|The ability of the securing device to resist endotracheal tube dislodgement under axial strain for patients in the supine position was measured. The endotracheal tube, once secured with either tape or the Haider airway device, encountered an axial force to simulate the endotracheal tube being pulled from the mouth. The force increased over approximately 5 seconds until the target of 15 N was reached or until the principal investigator deemed that the force be aborted to prevent possible tracheal extubation. The change in position, measured in cm, was recorded.|5 minutes after intubation (which occurs at the beginning of the anesthesia about 2-5 minutes after the patient goes to sleep).|||centimeters||Standard Deviation|Mean
640493|NCT02347176|Secondary|Change From Baseline in Pruritus Numeric Rating Scale (NRS) (7-day Mean Score) at Week 12|Pruritus assessed using an NRS (0 - 10) with 0= no itch and 10= worst imaginable itch. Daily pruritus assessments were summarized as weekly peak score and a change from baseline in weekly peak score was calculated. The data presented here is Adjusted mean change after excluding the data from participants who took prohibited medications.|Week 12|"The intent-to-treat (ITT) population included all randomized and treated participants, grouped according to assigned treatment. Here, N is number of participants analyzed for this outcome measure."||units on a scale||Standard Error|Mean
640494|NCT02347176|Secondary|Percentage of Participants Achieving 50 Percent (%) Reduction From Baseline in SCORAD at Week 12|SCORAD 50 responder is defined as a participant who achieves at least a 50% reduction in SCORAD score from baseline.|Week 12|"The intent-to-treat (ITT) population included all randomized and treated participants, grouped according to assigned treatment. Here, N is number of participants analyzed for this outcome measure."||Percentage of participant|||Number
640495|NCT02347176|Secondary|Absolute Change From Baseline in Scoring of Atopic Dermatitis (SCORAD) at Week 12|The SCORAD is a clinical tool for assessing the severity (that is, extent, intensity) of AD. The tool evaluates the extent and intensity of the AD lesions, along with participant symptoms. The maximum total score is 103, with higher values indicating more severe disease. The data presented here is Adjusted mean change after excluding the data from participants who took prohibited medications.|Week 12|"The intent-to-treat (ITT) population included all randomized and treated participants, grouped according to assigned treatment. Here, N is number of participants analyzed for this outcome measure."||units on a scale||Standard Error|Mean
640496|NCT02347176|Secondary|Percentage of Participants Achieving 50 Percent (%) Reduction From Baseline in Eczema Area and Severity Index (EASI) at Week 12|EASI50 responder is defined as a participant who achieves at least a 50% reduction in EASI score from baseline.|Week 12|"The intent-to-treat (ITT) population included all randomized and treated participants, grouped according to assigned treatment. Here, N is number of participants analyzed for this outcome measure."||Percentage of participant|||Number
640497|NCT02347176|Secondary|Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment Emergent Adverse Events|AEs observed in participants with clinically significant ECG abnormalities were assessed. ECG parameters included heart rate, RR, PR, QRS and QT intervals. Treatment-emergent adverse events between administration of investigational product and Week 22 that were absent before treatment or that worsened relative to pre-treatment state.|From Study Drug Administration to Week 22|As-treated population included all treated participants, grouped according to actual treatment received.||Participant|||Number
640498|NCT02347176|Secondary|Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events|An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Treatment-emergent adverse events between first dose of study drug and 10 weeks after the last dose that were absent before treatment or that worsened relative to pre-treatment state. Laboratory evaluations (haematology, serum chemistry and urinalysis) of blood and urine samples were performed.|From Study Drug Administration to Week 22|As-treated population included all treated participants, grouped according to actual treatment received.||Participant|||Number
640499|NCT02347176|Secondary|Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as Treatment Emergent Adverse Events|Vital sign parameters included blood pressure, temperature, pulse rate, and respiratory rate. TEAEs were present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug until Week 22.|From Study Drug Administration to Week 22|As-treated population included all treated participants, grouped according to actual treatment received.||Participant|||Number
640500|NCT02347176|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) present at baseline that worsened in intensity after administration of investigational product or events absent at baseline that emerged after administration of study drug until Week 22. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening situation (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received Tralokinumab. Treatment-emergent adverse events between administration of investigational product and Week 22 that were absent before treatment or that worsened relative to pre-treatment state.|From Study Drug Administration to Week 22|As-treated population included all treated participants, grouped according to actual treatment received.||Participant|||Number
640501|NCT02347176|Primary|Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of 0 (Clear) or 1 (Almost Clear) and at Least a 2-Grade Reduction From Baseline at Week 12|The IGA allows investigators to assess overall disease severity at one given time point and consists of a 6-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease, and 5 = very severe disease). A participant has IGA response if they achieve a score of 0 (clear) or 1 (almost clear) and at least a 2-grade reduction from baseline.|Week 12|"The ITT population included all randomized and treated participants, grouped according to assigned treatment. Here, N is number of participants analyzed for this outcome measure."||Percentage of participant|||Number
640602|NCT02341859|Secondary|Vision (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Subjective ratings of vision for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline, 3 hours, and 6 hours. (Scale 0-100, 0=cannot see due to blur vision, 100=clear vision without any blur image).|Baseline, 3 hours, 6 hours|||units on a scale||Standard Deviation|Mean
640502|NCT02347176|Primary|Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 12|EASI evaluates 4 natural anatomical regions for severity and extent of key disease signs and focuses on the key acute and chronic signs of inflammation (erythema, induration/papulation, excoriation, and lichenification). The maximum total score is 72, with higher values indicating more severe disease. The data presented here is Adjusted mean change after excluding the data from participants who took prohibited medications.|Week 12|"The intent-to-treat (ITT) population included all randomized and treated participants, grouped according to assigned treatment. Here, N is number of participants analysed for this outcome measure."||units on a scale||Standard Error|Mean
640503|NCT02347085|Secondary|Peak Change From Baseline in IC Following the Morning Dose on Day 29|Peak Change from Baseline in IC following the morning dose on Day 29|Day 29|MITT Population||Liters||95% Confidence Interval|Mean
640504|NCT02347085|Secondary|Peak Change From Baseline in Inspiratory Capacity (IC) Following the Evening Dose on Day 29|Peak Change from Baseline in Inspiratory Capacity (IC) following the evening dose on Day 29|Day 29|MITT Population||Liters||95% Confidence Interval|Mean
640505|NCT02347085|Secondary|Morning Pre-Dose Trough FEV1 on Day 30|Morning Pre-Dose Trough FEV1 on Day 30|Day 30|MITT Population||Liters||95% Confidence Interval|Mean
640506|NCT02347085|Secondary|Morning Pre-Dose Trough FEV1 on Day 29|Morning Pre-Dose Trough FEV on Day 29|Day 29|MITT Population||Liters||95% Confidence Interval|Mean
640507|NCT02347085|Secondary|Peak Change From Baseline in FEV1 on Day 29|Peak Change From Baseline in FEV1 following the morning dose on Day 29|Day 29|MITT Population||Liters||95% Confidence Interval|Mean
640508|NCT02347085|Secondary|Peak Change From Baseline in FEV1 on Day 29|Peak Change From Baseline in FEV1 following evening Dose on Day 29|Day 29|MITT Population||Liters||95% Confidence Interval|Mean
640509|NCT02347085|Secondary|FEV1 AUC0-12 on Day 29|FEV1 AUC0-12 on Day 29|Day 29|MITT Population||Liters||95% Confidence Interval|Mean
640510|NCT02347085|Secondary|FEV1 AUC12-24 on Day 29|FEV1 AUC12-24 on Day 29|Day 29|MITT Population||Liters||95% Confidence Interval|Mean
640511|NCT02347085|Primary|FEV1 AUC0-24 on Day 29|Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC)0-24 on Day 29|Day 29|Modified-Intent-to-Treat (MITT) Population||Liters||95% Confidence Interval|Mean
640512|NCT02347072|Secondary|Peak Change From Baseline in IC Morning|Peak Change From Baseline in IC Morning|Baseline and Day 29|Subjects in the MITT Population who had a sufficient number of post dose FEV1 measurements||Liters||95% Confidence Interval|Least Squares Mean
640513|NCT02347072|Secondary|Peak Change From Baseline in IC (Inspiratory Capacity) Evening|Peak Change From Baseline in IC Evening|Baseline and Day 29|Subjects in the MITT Population who had a sufficient number of post dose FEV1 measurements||Liters||95% Confidence Interval|Least Squares Mean
640514|NCT02347072|Secondary|Morning Pre-Dose Trough FEV1 on Day 30|Morning Pre-Dose Trough FEV1 on Day 30|Day 30|Subjects in the MITT Population who had a sufficient number of post dose FEV1 measurements||Liters||95% Confidence Interval|Least Squares Mean
640515|NCT02347072|Secondary|Morning Pre-Dose Trough FEV1 on Day 29|Morning Pre-Dose Trough FEV1 on Day 29|Day 29|Subjects in the MITT Population who had a sufficient number of post dose FEV1 measurements||Liters||95% Confidence Interval|Least Squares Mean
640516|NCT02347072|Secondary|Peak Change From Baseline in FEV1 Morning|Peak Change From Baseline in FEV1 Morning|Baseline and Day 29|Subjects in the MITT Population who had a sufficient number of post dose FEV1 measurements||Liters||95% Confidence Interval|Least Squares Mean
640517|NCT02347072|Secondary|Peak Change From Baseline in FEV1 Evening|Peak Change From Baseline in FEV1 Evening|Baseline and Day 29|MITT Population||Liters||95% Confidence Interval|Least Squares Mean
640518|NCT02347072|Secondary|FEV1 AUC0-12|Normalized FEV1 AUC0-12|Pre dose, 15 and 30 minutes, 1, 2, 4, 8, and 12 hours post the morning dose on Day 29|Subjects in the MITT Population who had a sufficient number of post dose FEV1 measurements||Liters||95% Confidence Interval|Least Squares Mean
640519|NCT02347072|Secondary|FEV1 AUC12-24|Normalized FEV1 AUC12-24|Pre dose, 15 and 30 minutes, 1, 2, 4, 8, and 12 hours post the evening dose on Day 29|Subjects in the MITT Population who had a sufficient number of post dose FEV1 measurements||Liters||95% Confidence Interval|Least Squares Mean
640520|NCT02347072|Primary|Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) 0-24|Normalized Forced Expiratory Volume in 1 second (FEV1) Area Under the Curve (AUC) 0-24|Pre dose, 15 and 30 minutes, 1, 2, 4, 8, 12, 12.25, 12.5, 13, 14, 16, 22, and 24 hours post the morning dose on Day 29|Subjects in the Modified Intent to Treat (MITT) Population who had a sufficient number of post dose FEV1 measurements||Liters||95% Confidence Interval|Least Squares Mean
640521|NCT02346877|Secondary|Beliefs About Medicines Questionnaire (BMQ)|BMQ consists of two five-item scales assessing patients’ beliefs about the necessity of Enbrel® for controlling their rheumatoid arthritis and their concerns about potential adverse consequences of taking Enbrel®. Using a five-point Likert scale, on each of necessity and concerns, the individual items within both scales are summed. The total scores for the Necessity and Concerns Scales range from 5 to 25. Higher scores indicate stronger beliefs.|52 weeks|Efficacy endpoints were not evaluated because the study was prematurely closed and no participants completed the study.|||||
640522|NCT02346877|Secondary|Adherence to Study Drug up to 52 Weeks|A participant’s adherence is determined as a medication possession ratio (MPR) of at least 80%. The MPR is the ratio of the total number of weeks’ supply, based on pharmacy data, of Enbrel® divided by either 52 weeks or duration on study if a physician stops prescribing Enbrel® due to an adverse drug reaction or lack of efficacy.|52 weeks|Efficacy endpoints were not evaluated because the study was prematurely closed and no participants completed the study.|||||
640523|NCT02346877|Primary|Persistence of Study Drug Measured at 52 Weeks|A participant is persistent if the date of the last prescription filled plus the number of weeks supply of the prescription is greater than or equal to 52 weeks from enrolment and the eDiary confirms Enbrel® from the prescription was injected. A participant is not persistent if the last prescription filled plus the number of weeks supply of the prescription is less than 52 weeks from enrolment and the eDiary confirms there was no injection of Enbrel®, or, a participant is not persistent if the participant has a gap in treatment of more than 4 consecutive weeks for no medical reason at any time in the 52 week study period.|52 weeks|Efficacy endpoints were not evaluated because the study was prematurely closed and no participants completed the study.|||||
641025|NCT02322892|Other Pre-specified|Time on Vasopressors||Limit 60 days||||||
641026|NCT02322892|Other Pre-specified|Time on Mechanical Ventilation||Limit 60 days||||||
640524|NCT02346721|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as:
On-treatment virologic failure:
Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)
Virologic relapse:
Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 24|Full Analysis Set||percentage of participants|||Number
640525|NCT02346721|Secondary|HCV RNA Change From Baseline||Baseline to Week 12|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
640526|NCT02346721|Secondary|Percentage of Participants With HCV RNA < LLOQ While on Treatment||Baseline to Week 12|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants||95% Confidence Interval|Number
640527|NCT02346721|Secondary|Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set||percentage of participants||95% Confidence Interval|Number
640528|NCT02346721|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 12 weeks|Safety Analysis Set||percentage of participants|||Number
640529|NCT02346721|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.|Posttreatment Week 12|Full Analysis Set (FAS) included all enrolled participants who took at least 1 dose of study drug.||percentage of participants||95% Confidence Interval|Number
640530|NCT02345720|Primary|Corneal Staining|The corneal fluorescein staining average surface area in % of the upper corneal quadrant was reported.|30 Days Post Wear|The analysis population consists of all subjects that were dispensed a study lens.||percentage of upper corneal quadrant||Standard Deviation|Mean
640531|NCT02345720|Primary|Limbal Staining|Measured via Ocular Photography using proprietary algorithm. The limbal conjunctival lissamine green staining average surface area in % of the overall limbal area was reported.|30 Days Post Wear|The analysis population consist of all subjects that were dispensed a study lens.||percentage of limbal area||Standard Deviation|Mean
640532|NCT02345720|Primary|Upper Eye Lid Margin Staining|Upper Eye Lid Margin Staining is assessed via Ocular Photography using proprietary algorithm. The average grade across upper eye lid margin was reported in mm^2.|30 days Post wear|The analysis population consists of all subjects that were dispensed a study lens.||mm^2||Standard Deviation|Mean
640533|NCT02345031|Secondary|Pharmacokinetic of AUT00063, Plasma Levels|Exposure of AUT00063 ng/ml, in plasma levels at Day 28|28 Days|||ng||Standard Deviation|Mean
640534|NCT02345031|Secondary|To Further Investigate the Safety and Tolerability Profile of Repeat Administration of AUT00063 by Assessing Vital Signs, Physical Examination, Laboratory Exams and ECG|To investigate the safety and tolerability of AUT00063 by assessing vital signs, physical examination, laboratory exams and electrocardiography (ECG)|42 Days||||||
640535|NCT02345031|Secondary|Analysis of Change From Baseline in Adaptive Test of Temporal Resolution (ATTR) on End-Point Visit Day 28|Final Average GDT Within-Channel at Day 28: Change from Baseline; FAS Population|28 days|FAS Population||ms||95% Confidence Interval|Least Squares Mean
640536|NCT02345031|Secondary|Analysis of Change From Baseline in Adaptive Test of Temporal Resolution (ATTR) on End-Point Visit Day 28|Final Average GDT Across-Channel at Day 28: Change from Baseline; FAS Population|28 days|FAS Population||ms||95% Confidence Interval|Least Squares Mean
640537|NCT02345031|Primary|Change in Hearing Loss After 4 Weeks of Treatment|To compare the change in hearing using the QuickSIN test (speech in noise performance) from baseline (Day 1 to Day 28) between AUT00063 and placebo. The QuickSIN test measures the level of signal compared to the noise that is required to achieve 50% recognition. The test is administered in a sound booth at 70-dB HL binaurally via insert-ear phones. Three lists are administered to each individual subject and the threshold or 50% signal-to-noise ratio (SNR) is calculated as the mean of the three lists completed. Each list consists of six sentences with five key words to be scored per sentence. The sentences are presented in four-talker babble noise. The sentences are presented at pre-recorded signal-to-noise ratios which decrease in 5-dB steps from 25 (very easy) to 0 (extremely difficult).|28 days|Full Analysis Set||decibels (dB)||95% Confidence Interval|Least Squares Mean
640538|NCT02344745|Secondary|Wong Baker Pain Scale|Pain was measured on the Wong Baker scale from 0-10. Higher values indicate more pain.|15 min after removal of the urodynamics catheters|||units on a scale||Full Range|Median
640539|NCT02344745|Secondary|Anxiety Measured by VAS|Anxiety was measured using a visual analogue scale, from 0-10 cm. All measurements were rounded to the nearest 0.5 cm. Higher values indicate more anxiety.|15 min after removal of the urodynamics catheters|||cm||Full Range|Median
640540|NCT02344745|Secondary|Wong Baker Pain Scale|Pain was measured on the Wong Baker scale from 0-10. Higher values indicate more pain.|At the time of catheter placement|||units on a scale||Full Range|Median
640541|NCT02344745|Primary|Anxiety Measured by VAS|Anxiety was measured using a visual analogue scale, from 0-10 cm. All measurements were rounded to the nearest 0.5 cm. Higher values indicate more anxiety.|At the time of catheter placement|||cm||Full Range|Median
640542|NCT02344407|Primary|Immunogenicity Measures (ELISA and Neutralization Antigen-specific Assays for Antibody.|Antibody Response at 1-Month (EU/mL) for Participants Without Elevated Levels at Entry|One month|Participants with 1-month antibody data without elevated antibody levels at entry||EU/mL||95% Confidence Interval|Geometric Mean
640543|NCT02344407|Primary|Serious Adverse Events.|Number of Participants Experiencing Serious Adverse Events in First 30 Days|One month|All Participants Randomized||Participants|||Count of Participants
640544|NCT02344342|Secondary|Days to Hospitalization or Death (if it Occurs Within 180 Days)|Time to Hospitalization (if participant was hospitalized and did not die) or death whichever came first. In fact all participants who died in the follow up period were hospitalized first, so actual data reported below also represents time to hospitalization for all participants.|180 days|All participants who completed 180 days or died prior to 180 days (all who completed study and all listed in all cause mortality)||days till hospitalization||95% Confidence Interval|Mean
648260|NCT02107014|Primary|Change in IP-10 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].|||pg/mL||95% Confidence Interval|Median
640545|NCT02344342|Secondary|Minnesota Living With Heart Failure Questionnaire|It provides a total score (range 0–105, where 0 is best quality of life up to 105 as worst Health Related Quality of Life),|180 day follow up|2 patients completed the study, whose answers were not coded into the analysis for the questionnaire, therefore they are not included in the report for this secondary end point. The subjects included completed the 180 follow up period. Subjects that had less than 180 days of follow up at the time of study closure are excluded from this analysis.||units on a scale||Full Range|Mean
640546|NCT02344342|Secondary|Self Care for Heart Failure Index Score|The self care for heart failure index score ranges from 22 to 88 where 22 is the lowest score meaning cares for oneself least well and 88 means one is most confident or able to care for oneself properly.|180 day follow up|Two participants completed the study but did not answer all of the questions on this questionnaire, and therefore they are not included in the report for this secondary end point. The subjects included completed the 180 follow up period. Subjects that had less than 180 days of follow up at the time of study closure are excluded from this analysis.||units on a scale||Full Range|Mean
640547|NCT02344342|Primary|Number of Days Hospitalized or Dead in the 180 Day Follow up Period|This is the total combined number of days that all participants in each arm were hospitalized or dead between day 1 and day 180. It is a method to combine the endpoints of death and hospitalization used in heart failure trials. Days hospitalized for all participants are added to days dead for all participants, per arm.|180 days (6 months)|The subjects included in this measure each completed the 180 follow up period or died within the 180 follow up period. Subjects that had less than 180 days of follow up at the time of study closure are excluded from this analysis.||Days|||Number
640548|NCT02343380|Secondary|Intra-individual Variations in the Values of Glucagon-like Peptide-1 After the Morning and Evening Meal Consumption||Every 30-min from the beginning of the meal for 180-min||||||
640549|NCT02343380|Secondary|Intra-individual Variations in the Values of Acylated Ghrelin After the Morning and Evening Meal Consumption||Every 30-min from the beginning of the meal for 180-min||||||
640550|NCT02343380|Secondary|Intra-individual Variations in the Values of Adrenalin and Noradrenalin, After the Morning and Evening Meal Consumption||Every 30-min from the beginning of the meal for 180-min||||||
640551|NCT02343380|Secondary|Intra-individual Variations in the Values of Leptin After the Morning and Evening Meal Consumption||Every 30-min from the beginning of the meal for 180-min||||||
640552|NCT02343380|Secondary|Variation in Morning Triglyceride and Free Fatty Acid (FFA) Area-Under the Curve (AUC)s After the Consumption of a Meal at 8:00 am Compared With Evening Glucose and Insulin AUCs After the Consumption of the Same Meal at 8:00 pm|"Triglycerides and FFA values measured every 30 minutes after meal for 180-min. Time 0 was before the meal. Times 30, 60, 90, 120, 150 and 180 were referred to the time intervals in minutes from the beginning of the meal. AUCs were calculated according to the trapezoidal model.
FFA concentrations were measured by a fluorometric assay. Plasma triglycerides were assayed by enzymatic colorimetric method.
Serum glucose was measured by enzymatic colorimetric assay; serum insulin was determined by immunoradiometric assay."|From the beginning of the meal for 180-min|||mmol/l*h||95% Confidence Interval|Mean
640553|NCT02343380|Secondary|Variation in Morning Glucose and Insulin Area-Under the Curve (AUC)s After the Consumption of a Meal at 8:00 am Compared With Evening Glucose and Insulin AUCs After the Consumption of the Same Meal at 8:00 pm|"Glucose and insulin values measured every 30 minutes after meal for 180-min. Time 0 was before the meal. Times 30, 60, 90, 120, 150 and 180 were referred to the time intervals in minutes from the beginning of the meal. AUCs were calculated according to the trapezoidal model.
Serum glucose was measured by enzymatic colorimetric assay; serum insulin was determined by immunoradiometric assay."|From the beginning of the meal for 180-min|||ug/ml*h||95% Confidence Interval|Mean
640554|NCT02343380|Primary|Intra-individual Variation in Morning Diet-induced Thermogenesis (DIT) Evaluated by Calorimetric Exam After the Consumption of a Meal at 8:00 am Compared With Evening DIT Evaluated by Calorimetric Exam After the Consumption of the Same Meal at 8:00 pm|Indirect calorimetry by Deltatrac II (DATEX, Division of Instruments Corp. Helsinki, Finland) is used to measure the rate of energy expenditure before- and after- the meal.Diet-induced thermogenesis is considered as the difference between average after-meal and basal energy expenditure.|Before and 180-min from the beginning of the meal|||kcal/min||95% Confidence Interval|Mean
640555|NCT02343159|Secondary|Work Productivity and Activity Impairment Questionnaire (WPAI: MS Version 2.0)|The WPAI questionnaire is a validated instrument to measure impairments in work and activities. The WPAI yields four types of scores: 1. Absenteeism (work time missed) 2. Presenteesism (impairment at work / reduced on-the-job effectiveness) 3. Work productivity loss (overall work impairment / absenteeism plus presenteeism) 4. Activity Impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.|Month 6, Month 12|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.|||||
640556|NCT02343159|Secondary|Multiple Sclerosis Impact Scale (MSIS-29)|The 29-item MSIS-29 is a participant-reported outcome measure to assess the impact of MS on day-to-day life during the past 2 weeks from a participants perspective; it measures 20 physical items and 9 psychological items. The physical score is generated by summing individual items and then transforming to a scale with a range of 0 to 100, where high scores indicate worse health.|Month 6, Month 12|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.|||||
640557|NCT02343159|Secondary|Compliance Rates at Month 6 and 12|Compliance rates defined as the proportion of actual DMF doses taken per label according to feedback from MEMS data over total expected DMF doses per label during treatment period.|Month 6, Month 12|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.|||||
640558|NCT02343159|Secondary|Persistence Rates at Months 6 and 12|Persistence rates defined as the proportion of time on treatment over the study observation time period.|Month 6, Month 12|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.|||||
640960|NCT02326844|Other Pre-specified|Secondary Mutation of Breast Cancer 1 (BRCA1) and Breast Cancer 2 (BRCA2)|Patients will undergo a mandatory biopsy at baseline and Next Generation Sequencing to elucidate the secondary mutations of BRCA1 and BRCA2 will be performed.|Baseline||03/2018||||
640559|NCT02343159|Secondary|Overall Adherence Rates at Month 6: Arm 2 vs. Arm 1|Adherence is defined as the proportion of time on treatment over the study observation time period, times the proportion of actual DMF doses taken per label according to feedback from MEMS data over the total expected DMF doses per label during a treatment period.|Month 6|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.|||||
640560|NCT02343159|Secondary|Overall Adherence Rates at Month 6: Arm 3 vs. Arm 1|Adherence is defined as the proportion of time on treatment over the study observation time period, times the proportion of actual DMF doses taken per label according to feedback from MEMS data over the total expected DMF doses per label during a treatment period.|Month 6|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.|||||
640561|NCT02343159|Secondary|Overall Adherence Rates at Month 12: Arm 2 vs. Arm 1|Adherence is defined as the proportion of time on treatment over the study observation time period, times the proportion of actual DMF doses taken per label according to feedback from MEMS data over the total expected DMF doses per label during a treatment period.|Month 12|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.|||||
640562|NCT02343159|Primary|Overall Adherence Rates at Month 12: Arm 3 vs. Arm 1|Adherence is defined as the proportion of time on treatment over the study observation time period, times the proportion of actual DMF doses taken per label according to feedback from MEMS data over the total expected DMF doses per label during a treatment period.|Month 12|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.|||||
640563|NCT02343081|Primary|AUC0-∞|Extent of absorption of Temozolomide from time (0) to infinity (∞) will be measured after oral administration of the test product (Dralitem®, Monte Verde S.A.) or the reference product (Temodal®, Schering-Plough).|0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0 hours on Days 3 and 4|All those subjects who completed the study and were compliant with all the protocol procedures were considered evaluable for statistical pharmacokinetic analysis. Those who received at least one dose of the products under study but did not comply with the study procedures were included in the safety analysis only.||mcg*h/mL||Standard Deviation|Mean
640564|NCT02343081|Primary|AUC0-t|Extent of absorption of Temozolomide from time (0) to the last quantifiable concentration (t) will be measured after the oral administration of the test product (Dralitem®, Monte Verde S.A.) or the reference product (Temodal®, Schering-Plough)|0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.75, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0 hours on Days 3 and 4|All those subjects who completed the study and were compliant with all the protocol procedures were considered evaluable for statistical pharmacokinetic analysis. Those who received at least one dose of the products under study but did not comply with the study procedures were included in the safety analysis only.||mcg*h/mL||Standard Deviation|Mean
640565|NCT02343081|Other Pre-specified|T1/2|Time required for Temozolomide plasma concentration to decrease by 50%|0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0 hours on Days 3 and 4|||hours||Standard Deviation|Mean
640566|NCT02343081|Other Pre-specified|Kel|Rate at which Temozolomide is removed from the body.|0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0 hours on Days 3 and 4|||1/h||Standard Deviation|Mean
640567|NCT02343081|Secondary|Number of Adverse Events (AEs) and Serious Adverse Events (SAEs)|AEs and SAEs will be collected from the start of study treatment and until two weeks post last dose. If AEs or SAEs extend in time and are not resolved before the end of the 2-week follow up period, this period shall last until the event/s are resolved.|Up to two weeks post last dose||||||
640568|NCT02343081|Primary|Cmax|Rate of absorption of Temozolomide (Cmax) will be measured after the oral administration of the test product (Dralitem®, Monte Verde S.A.) or the reference product (Temodal®, Schering-Plough).|0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0 hours on Days 3 and 4|All those subjects who completed the study and were compliant with all the protocol procedures were considered evaluable for statistical pharmacokinetic analysis. Those who received at least one dose of the products under study but did not comply with the study procedures were included in the safety analysis only.||mcg/mL||Standard Deviation|Mean
640575|NCT02342704|Secondary|Change From Baseline in SDMT at Week 52|The SDMT measures the time to pair abstract symbols with specific numbers. The test requires elements of attention, visuoperceptual processing, working memory, and psychomotor speed. The score is the number of correctly coded items from 0-110 in 90 seconds. The total score provides a measure of the speed and accuracy of symbol-digit substitution.|Baseline, Week 52|Intent-to-treat population: all randomized participants who received at least 1 dose of study treatment and had both baseline and post-baseline values.||units on a scale||Standard Deviation|Mean
640576|NCT02342704|Secondary|Change From Baseline in Symbol Digit Modalities Test (SDMT) at Week 24|The SDMT measures the time to pair abstract symbols with specific numbers. The test requires elements of attention, visuoperceptual processing, working memory, and psychomotor speed. The score is the number of correctly coded items from 0-110 in 90 seconds. The total score provides a measure of the speed and accuracy of symbol-digit substitution.|Baseline, Week 24|Intent-to-treat population: all randomized participants who received at least 1 dose of study treatment and had both baseline and post-baseline values.||units on a scale||Standard Deviation|Mean
640577|NCT02342704|Secondary|Time to Complete Recovery From First Relapse|12-week confirmed complete EDSS recovery from first on-treatment relapse is defined as an EDSS score that is equal to or lower than the last pre-relapse EDSS score and sustained for at least 12 weeks.|Up to Week 52|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.|||||
640578|NCT02342704|Secondary|Cumulative Risk of Relapse|A clinical relapse was defined as new or recurrent neurological symptoms, not associated with fever, lasting for at least 24 hours, and followed by a period of 30 days of stability or improvement.|Up to Week 52|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.|||||
640579|NCT02342704|Secondary|Time to First Relapse|A clinical relapse was defined as new or recurrent neurological symptoms, not associated with fever, lasting for at least 24 hours, and followed by a period of 30 days of stability or improvement.|Up to Week 52|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.|||||
640580|NCT02342704|Secondary|Proportion of Participants With No Evidence of Disease Activity (NEDA)|NEDA was defined as all of the following: no relapses; no 12-week confirmed disability progression based on Expanded Disability Status Scale (EDSS; defined as an increase of 1.0 or more on the EDSS from baseline of 1.0 or more, or an increase of 1.5 or more from a baseline score of 0) that was sustained for 12 weeks; no new T1-Gd+ lesions on brain MRI. No new or enlarging T2-hyperintense lesions.|Up to Week 52|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.|||||
640581|NCT02342704|Secondary|Cumulative Number of New or Enlarging T2 Lesions||Baseline, Week 24|Intent-to-treat population: all randomized participants who received at least 1 dose of study treatment and had an assessment.||lesions||Standard Deviation|Mean
640582|NCT02342704|Secondary|Change From Baseline in Total T1-Hypointense and Total T2-Hyperintense Lesion Volumes at Week 52|As assessed by MRI.|Baseline, Week 52|Intent-to-treat population: all randomized participants who received at least 1 dose of study treatment and had an assessment.||percentage change||Standard Deviation|Mean
640583|NCT02342704|Secondary|Change From Baseline in Total T1-Hypointense and Total T2-Hyperintense Lesion Volumes at Week 24|As assessed by magnetic resonance imaging (MRI).|Baseline, Week 24|Intent-to-treat population: all randomized participants who received at least 1 dose of study treatment and had an assessment.||percentage change||Standard Deviation|Mean
640584|NCT02342704|Secondary|Cumulative Number of New T1-Gd+ Lesions||Baseline, Week 4, Week 12, Week 24|Intent-to-treat population: all randomized participants who received at least 1 dose of study treatment.||lesions||Standard Deviation|Mean
640585|NCT02342704|Primary|Cumulative Number of ≥ 6-Month Confirmed T1-Hypointense Lesions Arising From New On-Treatment T1-Gadolinium-Enhancing (Gd+) Lesions||Up to Week 52|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.|||||
640586|NCT02342561|Secondary|Description of Bacterial Skin Flora|Macroscopically unique colonies are isolated and analysed using Matrix-Assisted Laser Desorption/Ionization Time Of Flight analysis (MALDI-TOF). Finding are reported as prevalence of unique organism growth in the study population|Samples collected 75 minutes after drape application are analysed|||No. of cases|||Number
640587|NCT02342561|Primary|Bacterial Quantity|The bacterial quantity of the skin in sampled using the cylinder sampling method and incubated for 36-48 hours. Manually counted growth is reported as log10 Colony forming units (CFU)/cm^2|Measured after skin disinfection and 75 minutes after drape application|||Log10 CFU/cm^2||Inter-Quartile Range|Median
640623|NCT02341859|Primary|Corneal Shape Change - Wavefront Error - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Corneal shape change for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at 6 hours by the topographer measurement and functions (Wavefront Error Map)|6 hours|||microns||Standard Deviation|Mean
640588|NCT02342535|Primary|Change in Physical Activity (Minutes/Week)|To test for differences in physical activity, we used mixed-effects models for pre- and post-intervention accelerometer data. In these models, the outcome was daily minutes of bout corrected moderate-vigourous physical activity. Time (pre/post-intervention) was treated as a binary variable in order to measure changes in physical activity. Models controlled for accelerometer wear time and weekend day.|Baseline and 4 months|We did not collect any data from the children, so all the data analysis is from the data obtained from the 30 mothers. To test for differences in physical activity, we used mixed-effects models for pre- and post-intervention accelerometer data. In these models, the outcome was daily minutes of bout corrected moderate-vigourous physical activity.||minute/week activity||Standard Deviation|Mean
640589|NCT02342418|Secondary|This Outcome Measure is the Maximum Plasma Concentration of Tedizolid in Morbidly Obese Subjects Compared to Nonobese Subjects|The maximum concentration or Cmax value is measured in units of milligrams of tedizolid per liter of plasma.This comparison was made between the two groups of subjects that included morbidly obese subjects to matched non-obese subjects.|12 months|||Milligram per Liter||Full Range|Mean
640590|NCT02342418|Primary|This Outcome Measure is the Tedizolid Area Under the Concentration Time-curve From Time 0 to 72 Hours in Morbidly Obese Subjects and Matched Non-obese Subjects.|The area under the concentration-time curve is measured in units of mg of tedizolid per liter of plasma multiplied by time in hours (hour*mg/L) from time 0 to 72 hours. This comparison was made between the two groups of subjects that included morbidly obese subjects to matched non-obese subjects.|12 months|||hour*milligram/Liter||Full Range|Median
640591|NCT02342288|Secondary|Change and Correlations in Intraoperative Ocular Pressure in Lumbar Spine Fusion Patients|The secondary outcome is to evaluate factors (age, gender, duration of procedure, blood loss, intraoperative fluids, blood pressure, and carbon dioxide levels) looking for correlations with intraocular pressure changes.|prone; every 15 minutes; 1 hr until end of surgery||||||
640592|NCT02342288|Primary|Change in Intraoperative Ocular Pressure in Lumbar Spine Fusion Patients Head Raised 10 Degrees or Kept in Neutral Position|The objective is to determine if slight elevation of the head (10 degrees up from neutral) can decrease the IOP compared to remaining in neutral position (standard of care) for the entire surgery. The mean values for Δ IOP measurements (i.e. two eye average maximum IOP – two eye average baseline IOP obtained at first prone measurement).|Prone; 5 minutes after head raised to 10 degrees; every 15 minutes; 1 hr until end of surgery|Subjects who were undergoing elective lumbar spine surgery.||mm Hg||95% Confidence Interval|Mean
640593|NCT02342223|Secondary|Dermatology Life Quality Index (DLQI)|To evaluate the effects of Voluma injections on the subject’s quality of life (QOL) using the Dermatology Life Quality Index (DLQI). The DLQI is a validated 10-item questionnaire encompassing six different domains of QOL, including symptoms and feelings, daily activities, leisure, work/school, personal relationships, and treatment. Each question has four possible responses: “not at all/not relevant,” “a little,” “a lot,” and “very much” that corresponds to scores of 0, 1, 2, and 3, respectively, and a higher score suggests a higher level of QOL impairment. DLQI total score may range between 0 to 30.|Baseline to 12 months|||scores on a scale||Standard Deviation|Mean
640594|NCT02342223|Secondary|Subject Satisfaction Questionnaire (SSQ)|To evaluate the benefits and effects of Voluma injections on HIV-associated facial lipoatrophy as evidenced by the subject satisfaction questionnaire.|12 months|||percentage of total participants|||Number
640595|NCT02342223|Secondary|Number of Participants Rated Very Much Improved on the Global Aesthetic Improvement Scale (GAIS) by Participants|To evaluate the effectiveness of Voluma injections as a treatment for HIV-associated facial lipoatrophy over 12 months by assessing changes in the Global Aesthetic Improvement Scale (GAIS) based on pre- and post- treatment photography by participants.|Baseline to 12 months|||Participants|||Number
640596|NCT02342223|Secondary|Number of Participants Achieving Grade 1 in the Carruthers Lipoatrophy Severity Scale (CLSS)|To evaluate the effectiveness of Voluma injections as a treatment for HIV-associated lipoatrophy over 12 months by assessing changes in the Carruthers Lipoatrophy Severity Scale (CLSS) based on pre/post intervention photography by principal investigator (PI). CLSS is a 4-point grading scale (1 to 4, with a greater number indicating higher severity of HIV FLA). Grade 1: mild and localized facial lipoatrophy. Grade 2: deeper and longer atrophy, with the facial muscles beginning to show through. Grade 3: atrophic area is even deeper and wider, with the muscles clearly showing. Grade 4: lipoatrophy covers a wide area, extending up toward the eye sockets, and the facial skin lies directly on the muscles.|Baseline to 12 months|||Participants|||Number
640597|NCT02342223|Primary|Percentage of Participants With Device or Procedure Related Adverse Events|To evaluate the safety of Voluma injections as a treatment for HIV-associated facial lipoatrophy over 12 months by monitoring the incidence of adverse events (patient will keep a daily diary for initial 1 month and weekly phone calls will be made by study coordinator for initial 1 month to document possible adverse events, including injection site reactions, redness, bruising, swelling, and induration).|12 months|Common, transient adverse events reported in subject diaries include as follows.||percentage of total participants|||Number
640598|NCT02342223|Primary|Number of Participants Rated Very Much Improved on the Global Aesthetic Improvement Scale (GAIS) by Prinicple Investigator|"To evaluate the effectiveness of Voluma injections as a treatment for HIV-associated facial lipoatrophy over 12 months by assessing changes in the Global Aesthetic Improvement Scale (GAIS) based on pre- and post-treatment photography by principal investigator (PI). GAIS is a 5-point rating scale, ranging from worse, no change, improved, much improved, and very much improved."|Baseline to 12 months|||participants|||Number
640599|NCT02342197|Primary|Number of Oocytes Retrieved||12 months|||oocytes||Standard Deviation|Mean
640600|NCT02341859|Secondary|Lens Preferences (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Subjective ratings of lens preferences for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Which lens is preferred)|6 hours|Preference is missing for 1 participant in the stenfilcon A/delefilcon A group whom did not answer preference question of which lens is preferred.||participants|||Number
640601|NCT02341859|Secondary|Overall Wearing Satisfaction (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Subjective ratings of overall wearing satisfaction for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-100, 0=very poor, 100=very satisfied).|6 hours|||units on a scale||Standard Deviation|Mean
648261|NCT02107014|Primary|Change in SDF-1α From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].|||pg/mL||95% Confidence Interval|Median
640603|NCT02341859|Secondary|Handling (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Subjective ratings of handling for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline (ease of insertion) and 6 hours (ease of removal). (Scale 0-100, 0=cannot handle at all, 100=no problem at all).|Baseline and 6 hours|||units on a scale||Standard Deviation|Mean
640604|NCT02341859|Secondary|Comfort (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Subjective ratings of comfort for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline, 3 hours, and 6 hours. (Scale 0-100, 0=cannot wear, 100= no lens feeling).|Baseline, 3 hours, 6 hours|||units on a scale||Standard Deviation|Mean
640605|NCT02341859|Secondary|Dryness (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Subjective ratings of dryness for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline, 3 hours, and 6 hours. (Scale 0-100, 0=cannot wear, 100= no dryness).|Baseline, 3 hours, 6 hours|||units on a scale||Standard Deviation|Mean
640606|NCT02341859|Secondary|Red Eye (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Subjective ratings of red eye on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at 6 hours. 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe)|6 hours|||participants|||Number
640607|NCT02341859|Secondary|Itching Sensation on Removal (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Subjective ratings of itching sensation on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at 6 hours. 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe)|6 hours|||participants|||Number
640608|NCT02341859|Secondary|Itching Sensation on Insertion (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Subjective ratings of itching sensation on insertion for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at baseline. 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe)|Baseline|||participants|||Number
640609|NCT02341859|Secondary|Pain and Foreign Body Sensation (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Subjective ratings of pain and foreign body sensation for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at 6 hours. 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe)|6 hours|||participants|||Number
640610|NCT02341859|Secondary|Pain and Foreign Body Sensation (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Subjective ratings of pain and foreign body sensation for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at baseline. 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe)|Baseline|||participants|||Number
640611|NCT02341859|Primary|Lens Fit Overall - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Lens fit evaluation overall for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Optimal, Almost optimal, Border line to wear, Not acceptable (cannot wear)).|6 hours|||participants|||Number
640612|NCT02341859|Primary|Lens Fit Overall - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Lens fit evaluation overall for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Optimal, Almost optimal, Border line to wear, Not acceptable (cannot wear)).|Baseline|||participants|||Number
640613|NCT02341859|Primary|Lens Fit - Tightness on up Gaze Blink Lag - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Lens fit evaluation of tightness on up gaze blink lag for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours on removal. (Optimal, Acceptable, No lag, Falls from cornea)|6 hours|||participants|||Number
640614|NCT02341859|Primary|Lens Fit - Tightness on up Gaze Blink Lag - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Lens fit evaluation of tightness on up gaze blink lag for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline (insertion). (Optimal, Acceptable, No lag, Falls from cornea)|Baseline|||participants|||Number
640615|NCT02341859|Primary|Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Lens fit evaluation of post-blink movement on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Tight, Little tight, Optimal, Little loose, Loose)|6 hours|||participants|||Number
640616|NCT02341859|Primary|Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Lens fit evaluation of post-blink movement on insertion for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Tight, Little tight, Optimal, Little loose, Loose)|Baseline|||participants|||Number
640617|NCT02341859|Primary|Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Lens fit evaluation of vertical centration on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Up, Little up, Centered, Little low, Low)|6 hours|||participants|||Number
640618|NCT02341859|Primary|Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Lens fit evaluation of vertical centration on insertion for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Up, Little up, Centered, Little low, Low)|Baseline|||participants|||Number
640619|NCT02341859|Primary|Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Lens fit evaluation of horizontal centration on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Temporal, Little temporal, Centered, Little nasal, Nasal)|6 hours|||participants|||Number
640620|NCT02341859|Primary|Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Lens fit evaluation of horizontal centration on insertion for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Temporal, Little temporal, Centered, Little nasal, Nasal)|Baseline|||participants|||Number
640621|NCT02341859|Primary|Lens Fit - Corneal Coverage - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Lens fit evaluation for corneal coverage on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours with a 'yes' or 'no'.|6 hours|||participants|||Number
640622|NCT02341859|Primary|Lens Fit - Corneal Coverage - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Lens fit evaluation for corneal coverage on insertion for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline with a 'yes' or 'no'.|Baseline|||participants|||Number
640651|NCT02341144|Secondary|PACU Morphine Equivalents|morphine equivalents received in PACU|from entry in post-anesthesia care unit (PACU) until discharge, estimated 1-2 hours|||mg/kg||Full Range|Median
640624|NCT02341859|Primary|Corneal Shape Change - Tangential Radius - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Corneal shape change for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at 6 hours by the topographer measurement and functions (map function of Tangential Curvature Map)|6 hours|||mm||Standard Deviation|Mean
640625|NCT02341859|Primary|Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Corneal staining depth (ocular response) for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior|6 hours|||units on a scale||Standard Deviation|Mean
640626|NCT02341859|Primary|Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Corneal staining depth for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group A assessed at baseline. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior|Baseline|||units on a scale||Standard Deviation|Mean
640627|NCT02341859|Primary|Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Corneal staining extent (ocular response) for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior|6 hours|||units on a scale||Standard Deviation|Mean
640628|NCT02341859|Primary|Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Corneal staining extent (ocular response) for for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior|Baseline|||units on a scale||Standard Deviation|Mean
640629|NCT02341859|Primary|Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Corneal staining type (ocular response) for for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior|6 hours|||units on a scale||Standard Deviation|Mean
640630|NCT02341859|Primary|Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Corneal staining type (ocular response) for for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior|Baseline|||units on a scale||Standard Deviation|Mean
640631|NCT02341859|Primary|Limbal Redness - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Limbal redness for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior|6 hours|||units on a scale||Standard Deviation|Mean
640632|NCT02341859|Primary|Limbal Redness - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|"Limbal redness for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Scale 0-4, 0.5 steps 0=normal, 4=severe)
N - nasal, T - temporal, S - superior, I - interior"|Baseline|||units on a scale||Standard Deviation|Mean
640633|NCT02341859|Primary|Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Conjunctival indentation for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior|6 hours|||units on a scale||Standard Deviation|Mean
640634|NCT02341859|Primary|Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Conjunctival indentation for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior|Baseline|||units on a scale||Standard Deviation|Mean
640635|NCT02341859|Primary|Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Conjunctival staining for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior|6 hours|||units on a scale||Standard Deviation|Mean
640636|NCT02341859|Primary|Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Conjunctival staining for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior|Baseline|||units on a scale||Standard Deviation|Mean
640637|NCT02341482|Secondary|Number of Participants With Positive Response to Columbia-Suicide Severity Rating Scale (C-SSRS)|The C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment [C-CASA]) is an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior. C-SSRS assessed whether participant experienced the following: completed suicide (1), suicide attempt (2) (response of “Yes” on “actual attempt”), preparatory acts toward imminent suicidal behavior (3)(“Yes” on “preparatory acts or behavior”), suicidal ideation (4) (“Yes” on “wish to be dead”, “non-specific active suicidal thoughts”, “active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7)(“Yes” on “Has participant engaged in non-suicidal self-injurious behavior”).|Baseline up to Day 21|The safety analysis population included all participants who received at least 1 dose of the study medication.||participants|||Number
640638|NCT02341482|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.|Baseline up to 28 days after last study drug administration|The safety analysis population included all participants who received at least 1 dose of the study medication.||participants|||Number
640639|NCT02341482|Secondary|Number of Participants With Significant Change in Physical Examination From Previous Examination|A full physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. The brief physical examination focused on general appearance, the respiratory and cardiovascular systems, as well as towards participant reported symptoms.|Baseline up to Day 21|The safety analysis population included all participants who received at least 1 dose of the study medication.||participants|||Number
640640|NCT02341482|Secondary|Number of Participants With Significant Change in Neurological Examination From Previous Examination|The extended neurological examination, performed by a board certified neurologist, included observations for cerebellar (intention) tremor and for non-cerebellar tremors (eg, resting or positional), finger, nose, heel, shin, Romberg, tandem walking, positional and gaze evoked nystagmus, reflexes, muscle strength, cranial nerves, sensory function of upper and lower extremities. The brief neurological examination included an assessment of motor and sensory function, cranial nerves, reflexes, non-cerebellar tremor (eg, resting or positional) and cerebellar function. The assessment of cerebellar function were complemented by the Scale for Assessment and Rating of Ataxia (SARA).|Baseline up to Day 21|The safety analysis population included all participants who received at least 1 dose of the study medication.||participants|||Number
640641|NCT02341482|Secondary|Number of Participants With Electrocardiogram Data Meeting Criteria of Potential Clinical Concern|Electrocardiogram (ECG) parameters included time from ECG Q wave to the end of the T wave corresponding to electrical systole (QT) interval, beginning of the P wave until the beginning of the QRS complex (PR) interval, time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization (QRS) interval, QT interval corrected for heart rate (QTc) interval, and corrected QT interval using Fridericia's formula (QTcF). Criteria for ECG changes meeting potential clinical concern included: PR interval >=300 milliseconds (msec) or >=25% increase when baseline is >200 msec and >=50% increase when baseline is less than or equal to (=<)200 msec; QRS interval >=140 msec or >=50% increase from baseline; and QTcF >=450 to <480, 480 to <500 and >=500 msec or >=30 to 60 msec increase and also >=60 msec increase. The number of participants with potentially clinically significant ECG findings at any visit were reported.|Baseline up to Day 21|The safety analysis population included all participants who received at least 1 dose of the study medication.||participants|||Number
640642|NCT02341482|Secondary|Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern|Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: supine/sitting pulse rate more than (<)40 or less than (>)120 beats per minute (bpm); systolic blood pressure (SBP) more than or equal to (>=)30 millimeters of mercury (mm Hg) change from baseline in same posture or SBP <90 mm Hg, diastolic blood pressure (DBP) >=20 mm Hg change from baseline in same posture or DBP <50 mm Hg. IFB = increase from baseline; DFB = decrease from baseline.|Baseline up to Day 21|The safety analysis population included all participants who received at least 1 dose of the study medication.||participants|||Number
640643|NCT02341482|Secondary|Number of Participants With Abnormal Clinical Laboratory Measurements|The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell [RBC] count, mean corpuscular volume [MCV], mean corpuscular hemoglobin [MCH], mean corpuscular hemoglobin concentration [MCHC], platelet count, white blood cell [WBC] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen [BUN], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, alkaline phosphatase, uric acid, albumin, and total protein; urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin and microscopy [if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase]); others (follicle stimulating hormone [FSH], urine cotinine, and urine drug screening).|Baseline up to Day 21|The safety analysis population included all participants who received at least 1 dose of the study medication.||participants|||Number
640644|NCT02341482|Secondary|Apparent Oral Clearance (CL/F) of PF-04958242|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. Collected at Day 3 for PF-04958242 0.025 mg Arm and Day 17 for PF-04958242 0.025 mg + itraconazole 200 mg Arm.|Day 3(0,0.5,1,1.5,2,3,4,6,8,12 hours post-dose),Day 17(0,0.5,1,1.5,2,3,4,5,6,8,12 hours post-dose)|The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of interest measured.||milliliters per minute (mL/min)||Geometric Coefficient of Variation|Geometric Mean
640645|NCT02341482|Secondary|Predose Concentration (Ctrough) of PF-04958242||0 hour at Day 1,Day 2,Day 3,Day 4,Day 7,Day 10,Day 13,Day 16,and Day 17 (pre-dose)|All enrolled participants treated who received at least 1 dose of PF-04958242 and had at least 1 measureable concentration.||pg/mL||Geometric Coefficient of Variation|Geometric Mean
640646|NCT02341482|Secondary|Lowest Concentration Observed During the Dosing Interval (Cmin) of PF-04958242||Day 1 to Day 17|All enrolled participants treated who received at least 1 dose of PF-04958242 and had at least 1 measureable concentration.||pg/mL||Geometric Coefficient of Variation|Geometric Mean
640647|NCT02341482|Secondary|Time for Cmax (Tmax) of PF-04958242|Collected at Day 3 for PF-04958242 0.025 mg Arm and Day 17 for PF-04958242 0.025 mg + itraconazole 200 mg Arm.|Day 3(0,0.5,1,1.5,2,3,4,6,8,12 hours post-dose),Day 17(0,0.5,1,1.5,2,3,4,5,6,8,12 hours post-dose)|The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of interest measured.||hours||Full Range|Median
640648|NCT02341482|Primary|Maximum Observed Plasma Concentration (Cmax) of PF-04958242|Collected at Day 3 for PF-04958242 0.025 mg Arm and Day 17 for PF-04958242 0.025 mg + itraconazole 200 mg Arm.|Day 3(0,0.5,1,1.5,2,3,4,6,8,12 hours post-dose),Day 17(0,0.5,1,1.5,2,3,4,5,6,8,12 hours post-dose)|All enrolled participants treated who received at least 1 dose of PF-04958242 and had at least 1 measureable concentration.||pg/mL||Geometric Coefficient of Variation|Geometric Mean
640649|NCT02341482|Primary|Area Under the Concentration-Time Profile From Time 0 to Time Tau, the Dosing Interval, Where Tau = 12 Hours (AUCtau) of PF-04958242|AUCtau = area under the concentration-time profile from time 0 to time tau, the dosing interval, where tau = 12 hours. Collected at Day 3 for PF-04958242 0.025 mg Arm and Day 17 for PF-04958242 0.025 mg + itraconazole 200 mg Arm.|Day 3(0,0.5,1,1.5,2,3,4,6,8,12 hours post-dose),Day 17(0,0.5,1,1.5,2,3,4,5,6,8,12 hours post-dose)|The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of interest measured.||picogram*hours per milliliter pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
640650|NCT02341144|Secondary|PACU Length of Stay (LOS)|duration of time spent in the post-anesthesia care unit (PACU) from arrival to discharge|from entry in post-anesthesia care unit (PACU) until discharge, estimated 1-2 hours|||minutes||Full Range|Median
648262|NCT02107014|Primary|Change in MIP-1α From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].|||pg/mL||95% Confidence Interval|Median
640652|NCT02341144|Secondary|Pain Score of Zero|"proportion who reported a score of zero throughout their PACU stay using the Wong-Baker (WB) scale with zero being no pain"|from entry in the post-anesthesia care unit (PACU) until discharge, estimated 1-2 hours|||Participants|||Count of Participants
640653|NCT02341144|Secondary|Time to First Narcotic|duration until patient received first dose of narcotic in PACU|from entry in post-anesthesia care unit (PACU) to first narcotic|||minutes||Full Range|Median
640654|NCT02341144|Primary|Post Operative Pain Rating|Using the Wong-Baker FACES Pain Rating Scale (WBFPRS)- pain scores range from zero (no pain) to ten (worst pain) and the average score was reported|from entry in post-anesthesia care unit (PACU) until discharge, estimated 1-2 hours|||units on a scale||Full Range|Mean
640655|NCT02340338|Secondary|Number of Participants With Seroconversion|ELISA IgG against rTSST-1|through day 70|||participants|||Number
640656|NCT02340338|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Clinical observations and clinical laboratory values|through day 70|||participants with any solicited AE|||Number
640657|NCT02340104|Primary|Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Baricitinib Following Both the Oral and the IV Dose|AUC[0-∞] is is the area under the concentration verses time curve from zero to infinity, reported as nanograms times hour per milliliter (ng*h/mL).|Predose, 0.5, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 Hours Postdose|All participants who received at least 1 dose of study drug.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
640658|NCT02340000|Secondary|Willingness to Take the Study Antibiotic in the Future|whether participants said they would NOT take the antibiotic again|end of 10th day|||Participants|||Count of Participants
640659|NCT02340000|Secondary|Nasal Colonization With Resistant Bacteria|Clinicians performed anterior nasal cultures to look for colonization with penicillin-resistant pneumococci and other pathogens (stopped after participant #231 because of lack of funds).|baseline|All 231 participants were analyzed together regardless of treatment.||Participants|||Count of Participants
640660|NCT02340000|Secondary|SNOT-16 - Day 10|"Ratings on a scale from 0=none to 3=severe of 16 sinusitis-related symptoms. Total score can range from 0 to 48 (with 48 the most severe possible) of the 16 symptoms.
The outcome measure was the mean difference in the ratings of each of the 16 symptoms between day 0 and day 10 (values at day 0 minus values at day 10)."|day 0, end of 10th day|The number of participants who gave ratings at day 10.||units on a scale||Standard Deviation|Mean
640661|NCT02340000|Secondary|Subjective Improvement - Day 10|"rating of a lot better or no symptoms"|end of 10th day|The number of participants who gave a rating at day 10.||Participants|||Count of Participants
640662|NCT02340000|Secondary|SNOT-16 - Day 3|"Ratings on a scale from 0=none to 3=severe of 16 sinusitis-related symptoms. Total score can range from 0 to 48 (with 48 the most severe possible) of the 16 symptoms.
The outcome measure was the mean difference in the ratings of each of the 16 symptoms between day 0 and day 3 (values at day 0 minus values at day 3)."|day 0, end of 3 days of treatment|The number of participants who gave ratings at day 3.||units on a scale||Standard Deviation|Mean
640663|NCT02340000|Primary|"Subjective Improvement - Day 3 (Rating of a Lot Better or no Symptoms)"|"rating of a lot better or no symptoms"|end of 3 days of treatment|The number of participants who gave ratings at the end of day 3 of treatment||Participants|||Count of Participants
640664|NCT02339831|Secondary|General Pain|"Self-reported total pain medication consumption was recorded by patients and at the end of the four-week period converted into standard units for comparison as oxycodone equivalent dosage."|4-6 weeks post-op|||mg||Standard Deviation|Mean
640665|NCT02339831|Secondary|General Functional Orthopaedic Outcome Measures|Knee society score is an objective patient reported outcome survey to measure a patient's functional ability before and after knee arthroplasty. It is measured on a scale of 1-100. A score between 80-100 indicated excellent functioning, a score between 70-79 indicates good functioning, a score between 60-69 indicates fair functioning, and a score below 60 indicates poor functioning.|4-6 weeks post-op|||units on a scale||Standard Deviation|Mean
640666|NCT02339831|Secondary|General Activity Orthopaedic Outcome Measures|Western Ontario and McMaster Universities Arthritis Index is measured on a scale of 0-68. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.|4-6 weeks post-op|||units on a scale||Standard Deviation|Mean
640667|NCT02339831|Secondary|General Mental Orthopaedic Outcome Measures|Short form 36 mental health score. The scale is measured from 0-100. 0 is the lowest or worst possible level of functioning and 100 is the highest or best possible level of functioning.|4-6 weeks post-op|||units on a scale||Standard Deviation|Mean
640668|NCT02339831|Primary|Early Functional Outcome Knee Flexion|Knee-flexion was measured using an 8-inch goniometer.|4-6 weeks post op|||degrees||Standard Deviation|Mean
640669|NCT02339831|Primary|Early Function Outcome Kinesthesia|Kinesthesia was measured by recording the angle of the flexed knee and documenting how close the patient was able to reproduce the angle with closed eyes. The differences were recorded in degrees using an 8-inch goniometer.|4-6 weeks post op|||degress||Standard Deviation|Mean
640670|NCT02339831|Primary|Early Functional Outcome Proprioception|Biodex Balance Machine Score. The system consists of a multiaxial standing platform with a maximum tilt of 20 degrees. All participants were tested on level 8, and a balance index was calculated using the time and deviation (in degrees) on the platform relative to a neutral position. The normal range for adults 54-71 is 1.79 – 3.35. Lower values indicate better/greater stability.|4-6 weeks post-op|||units on a scale||Standard Deviation|Mean
640671|NCT02339831|Primary|Early Functional Outcome by Sit to Stand Test|"Sit-to-Stand test: After one demonstration of the sit-to-stand test, standing up from a seated position without support, two tests were timed and the better value recorded. Patient was asked to sit with back against chair and told to stand up without using any support. Arms were suggested to be folded in front of chest. Time started with recorded said Go."|4-6 weeks post-op|||seconds||Standard Deviation|Mean
640672|NCT02339831|Primary|Early Functional Outcome Strength|Quadriceps strength measurements using a hand held dynamometer|4-6 weeks post-op|||newton meter||Standard Deviation|Mean
640702|NCT02336763|Secondary|Frequency and Severity of Acute Toxicity Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4||Within 3 months of study treatment|study terminated early no analysis conducted. Data was not collected from any subject for this Outcome Measure.|||||
664924|NCT01779167|Secondary|Rate of Rituximab Related IgM Flare|Estimate the rate of rituximab-related IgM flare|Approximately 24 months per patient||||||
640673|NCT02339584|Primary|Mean Diurnal IOP Change From Baseline at Month 3|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. Diurnal IOP was defined as the average of the three timepoints measured: 9 AM, +2 Hrs and +7Hrs. Baseline was the average of the values for 2 eligibility visits. If one of the values was missing, the other non-missing value was taken as the baseline. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates greater improvement, ie, a reduction of IOP. Only one eye (study eye) contributed to the analysis.|Baseline (Day 0), Month 3|Per Protocol Analysis Set. Missing Month 3 data were imputed using a last observation carried forward method (LOCF).||mmHg||Standard Error|Mean
640674|NCT02339246|Primary|Evaluation of AUC(0-24) for Envarsus XR, Astagraf XL and Prograf.|"Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling times was used to calculate AUC(0-24).
Nominal time points used were:
Prograf sampling strategy (21 samples): Pre-dose (C0) and then 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20, and 24.
Envarsus XR sampling strategy (18 samples): Pre-dose (C0) and then 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 18, 21, 24, and 27.
Astagraf XL sampling strategy (17 samples): Pre-dose (C0) and then 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 18, 21, and 24."|8 days|One patient in the Envarsus XR arm was excluded from the analysis due to non compliance.||hr*ng/mL||Standard Deviation|Mean
640675|NCT02339246|Primary|Evaluation of C(Max) for Envarsus XR, Astagraf XL and Prograf.|"Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling times was used to calculate C(max).
Nominal time points used were:
Prograf sampling strategy (21 samples): Pre-dose (C0) and then 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20, and 24.
Envarsus XR sampling strategy (18 samples): Pre-dose (C0) and then 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 18, 21, 24, and 27.
Astagraf XL sampling strategy (17 samples): Pre-dose (C0) and then 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 18, 21, and 24."|8 days|One patient in the Envarsus XR arm was excluded from the analysis due to non compliance.||ng/mL||Standard Deviation|Mean
640676|NCT02339246|Primary|Evaluation of T(Max) for Envarsus XR, Astagraf XL and Prograf.|"Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling times was used to calculate T(max).
Nominal time points used were:
Prograf sampling strategy (21 samples): Pre-dose (C0) and then 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20, and 24.
Envarsus XR sampling strategy (18 samples): Pre-dose (C0) and then 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 18, 21, 24, and 27.
Astagraf XL sampling strategy (17 samples): Pre-dose (C0) and then 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 18, 21, and 24."|8 days|One patient in the Envarsus XR arm was excluded from the analysis due to non compliance.||hour||95% Confidence Interval|Median
640677|NCT02339038|Primary|Number of Subjects Who Achieve Sustained Viral Response (SVR12) 12 Weeks After the Stop of Treatment Drugs|The primary outcome was the number of patients with sustained viral response measured 12 weeks after the stop of treatment. The viral response was assessed by serum HCV RNA concentrations lower than the limit of quantification (<15IU/mL).|At least 12 weeks after completion of medication|The analyses included all patients who received at least one dose of ledipasvir-sofosbuvir||Participants|||Count of Participants
640678|NCT02338713|Secondary|Number of Participants Who Experience at Least 1 Treatment-Emergent Adverse Event (TEAE)||Baseline up to 14 days after last dose of study drug (Day 21)|The safety analysis set included all participants who were enrolled and received at least 1 dose of dummy treatment.||participants|||Number
640679|NCT02338713|Secondary|Tmax: Time to Reach the Cmax for Calcium||Days 3 and 6: predose and at multiple time-points (up to 24 hours) postdose. Day 3 for the non carbonated water reporting group and Day 6 for the Calcichew D3 reporting group|The PK analysis set consisted of all participants who received at least 1 dose of dummy treatment and who had at least 1 measurable serum concentration of calcium in each treatment period.||hours||Full Range|Median
640680|NCT02338713|Secondary|AUC(0-24): Area Under the Serum Concentration-Time Curve From Time 0 to 24 Hours Post-dose for Calcium||Days 3 and 6: predose and at multiple time-points (up to 24 hours) postdose. Day 3 for the non carbonated water reporting group and Day 6 for the Calcichew D3 reporting group|The PK serum analysis set of included participants who received at least 1 dose of dummy treatment and had at least 1 measurable serum concentration of calcium in each treatment period.||hr*mmol/L||Geometric Coefficient of Variation|Geometric Mean
640681|NCT02338713|Secondary|AUC(0-6): Area Under the Serum Concentration-Time Curve From Time 0 to 6 Hours for Calcium||Days 3 and 6: predose and at multiple time-points (up to 6 hours) postdose. Day 3 for the non carbonated water reporting group and Day 6 for the Calcichew D3 reporting group|The PK serum analysis set included all participants who received at least 1 dose of dummy treatment and had at least 1 measurable serum concentration of calcium in each treatment period.||hour*millimoles per litre (hr*mmol/L)||Geometric Coefficient of Variation|Geometric Mean
640682|NCT02338713|Secondary|Cmax: Maximum Observed Serum Concentration for Calcium||Days 3 and 6: predose and at multiple time-points (up to 24 hours) postdose. Day 3 for the non carbonated water reporting group and Day 6 for the Calcichew D3 reporting group|The PK serum analysis set included all participants who received at least 1 dose of dummy treatment and had at least 1 measurable serum concentration of calcium in each treatment period.||millimoles per litre(mmol/L)||Geometric Coefficient of Variation|Geometric Mean
640683|NCT02338713|Secondary|(Ca^2+ Ae24): Amount of Calcium Excreted in Urine From Time 0 to 24 Hours Post-dose|Ca2+ Ae0-24 was calculated as the urine volume of the urine collected from 0 to 24 hours multiplied by the calcium concentration measured in urine.|Days 3 and 6: pre-dose and at multiple time-points (upto 24 hours) postdose. Day 3 for the noncarbonated water reporting group and Day 6 for the Calcichew D3 reporting group|The PK urine analysis set included all participants who received at least 1 dose of dummy treatment and had at least 1 measurable urine concentration of calcium in each treatment period.||mmol||Geometric Coefficient of Variation|Geometric Mean
640684|NCT02338713|Secondary|PTH AUC (0-24): Area Under the Serum Concentration-Time Curve From Time 0 to 24 Hours for Parathyroid Hormone|The PTH AUC(0-24) is a measure of the area under the serum concentration-time curve from 0 to 24 hours of parathyroid hormone.|Days 3 and 6: pre-dose and at multiple time-points (up to 24 hours) postdose. Day 3 for the noncarbonated water reporting group and Day 6 for the calcichew D3 reporting group|The PD serum analysis set included all participants who received at least 1 dose of dummy treatment and had at least 1 measurable serum concentration of parathyroid hormone in each treatment period.||hr*pg/mL||Geometric Coefficient of Variation|Geometric Mean
640685|NCT02338713|Primary|(Ca^2+ Ae6): Amount of Calcium Excreted in Urine From Time 0 to 6 Hours Post-dose|Ca^2+ Ae6 was calculated as the urine volume of the urine collected from 0 to 6 hours multiplied by the calcium concentration measured in urine.|Days 3 and 6: pre-dose and at multiple time-points (upto 6 hours) postdose. Day 3 for the noncarbonated water reporting group and Day 6 for the Calcichew D3 reporting group|The pharmacokinetic(PK) urine analysis set included all participants who received at least 1 dose of dummy treatment and had at least 1 measurable urine concentration of calcium in each treatment period.||millimoles (mmol)||Geometric Coefficient of Variation|Geometric Mean
640686|NCT02338713|Primary|PTH AUC(0-6): Area Under the Serum Concentration-Time Curve From Time 0 to 6 Hours for Parathyroid Hormone|The PTH AUC(0-6) is a measure of the area under the serum concentration-time curve from 0 to 6 hours of parathyroid hormone.|Days 3 and 6: pre-dose and at multiple time-points (upto 6 hours) postdose. Day 3 for the noncarbonated water reporting group and Day 6 for the Calcichew D3 reporting group|The Pharmacodynamic(PD) serum analysis set included all participants who received at least 1 dose of dummy treatment and had at least 1 measurable serum concentration of parathyroid hormone in each treatment period.||hour*picogram per milliliter (hr*pg/mL)||Geometric Coefficient of Variation|Geometric Mean
640687|NCT02338336|Primary|Incidence of Zero Lesion Measurement|Percent of participants with lesion measurement either equal to 0 or greater than 0|6 weeks|ITT||percentage of participants|||Number
640688|NCT02338336|Primary|Lesion Assessment|Lesion (plantar wart) size measured in millimeters. Measurement of the longest dimension was recorded. Observed data|6 weeks|Intent-to-treat||millimeters||Standard Deviation|Mean
640689|NCT02338076|Secondary|T-cell Infiltrate in Occluded Versus Occluded With Petrolatum Compared With Normal Skin.|t-cell infiltrate in occluded skin versus occluded with petrolatum skin compared with normal skin ( healthy/not occluded skin)|3 days|||cells per micrometer squared||Standard Deviation|Mean
640690|NCT02338076|Secondary|Skin Thickness Difference Between Occluded Versus Occluded With Petrolatum Compared With Normal Skin.|skin thickness difference between occluded skin biopsy versus occluded with petrolatum skin biopsy compared with normal skin biopsy was examined|3 days|||micrometer||Standard Deviation|Mean
640691|NCT02338076|Primary|Measurement of Innate Immune Genes (IL6, IL8, and IL1B) in Skin Biopsy Samples With Petrolatum Occlusion, Normal Skin and Occlusion Without Petrolatum to See if There is Any Difference in Expression||3 days|||log of copy number||95% Confidence Interval|Mean
640692|NCT02338076|Primary|Expression Levels of Antimicrobial Peptides in Samples of Normal Appearing Skin and Skin Subjected to Occlusion With and Without Petrolatum.|The levels of expression of antimicrobial peptides (S100A8, S100A9, CCL20, PI3, lipocalin , human β-defensin 2 will be measured in skin biopsy samples with petrolatum occlusion, normal skin and occlusion without petrolatum to see if there is any difference in expression Please note- There is only 1 arm with 3 measures - for example, subject 1 had 3 biopsies and the outcome measure S100A8, S100A9, PI3, LIPOCALCIN, HUMAN B DEFENSIN were tested in all 3 biopsies. This is reported as the log of the number of copies. HUMAN B DEFENSIN and CCL20 was not collected. S100A7 and S100A12 were added to the analysis.|3 days|||log of copy number||95% Confidence Interval|Mean
640693|NCT02337959|Secondary|Pair Preference Rating|During the Reader Study the radiologists completed a paired preference rating using the following scale: -3, Image displayed on left is strongly preferred; -2, Image displayed on left is moderately preferred; -1, Image displayed on left is slightly preferred; 0, No preference between the images; 1, Image displayed on right is slightly preferred; 2, Image displayed on right is moderately preferred; 3, Image displayed on right is strongly preferred. Both the predicate and investigational images were randomly assigned to appear on the right or left monitors. A spreadsheet was used for managing the data. Prior to analysis, raw ratings were converted so that those in favor of the investigational device were made positive, and ratings in favor of the predicate device were made negative.|9 weeks after last x-ray capture|cadavers and live human subjects||units on a scale|Participants|Standard Error|Mean
640694|NCT02337959|Primary|Radlex Scale for Diagnostic Capability Ratings|1-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.|9 weeks after last x-ray capture|A total of 139 image pairs were included for the reader study. Of the 139 pairs, 122 were cadaver image pairs. Fifty-two (52) of the cadaver image pairs were from pediatric cadavers and seventy (70) pairs were from adult cadavers. A total of seventeen (17) adult live human subject pairs were included in the reader study.||units on a scale|Participants|Standard Error|Mean
640695|NCT02337062|Primary|Number of Patients With Complete Response (Protection From PONV)|To assess the efficacy of APD421 at 5 mg in combination with a standard anti-emetic in the prevention of post-operative nausea and vomiting (PONV) in adult, surgical patients at high risk of PONV.|24 hours|||Participants|||Count of Participants
640696|NCT02336958|Primary|Amount (ml) of Local Anesthetic Supplemented by Surgeon||during the intraoperative period|||ml||95% Confidence Interval|Mean
640697|NCT02336958|Primary|Number of Patients With Required Supplementation of Local Anesthetic by Surgeon||during the intraoperative period|||participants|||Number
640698|NCT02336763|Secondary|Disease-specific Survival|Cumulative incidence approach (K-M plots and Cox proportional hazard modeling) will be used to estimate disease-specific survival.|Up to 5 years|study terminated early no analysis conducted. Data was not collected from any subject for this Outcome Measure.|||||
640699|NCT02336763|Secondary|Distant Failure Rates|Cumulative incidence approach (Kaplan-Meier [K-M] plots and Cox proportional hazard modeling) will be used to estimate distant failure rates.|Up to 5 years|study terminated early no analysis conducted. Data was not collected from any subject for this Outcome Measure.|||||
640700|NCT02336763|Secondary|Overall Survival||Up to 5 years|study terminated early no analysis conducted. Data was not collected from any subject for this Outcome Measure.|||||
640701|NCT02336763|Secondary|Frequency and Severity of Late Toxicity Per NCI CTCAE Version 4||More than 3 months after study treatment|study terminated early no analysis conducted. Data was not collected from any subject for this Outcome Measure.|||||
640704|NCT02336763|Primary|Progression-free Survival||Up to 5 years|Study terminated early no analysis conducted. Subjects would need to be followed for up to 5 years to answer this objective. Subject 1 was followed 5 months and subject 2 was followed 2 months. Therefore, data was not collected from any subject for this Outcome Measure.|||||
640705|NCT02336607|Secondary|The Magnitude of Systolic and Diastolic Blood Pressure Changes From Baseline Among the Subjects Who Reached Target at 2 Weeks of Felodipine Sustained Release, Alone|The duration of the combination therapy was 2 weeks. Blood pressure was measured at week 2 of the trial.|2 weeks|The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of blood pressure at baseline and from at least one visit after randomization.||mmHg||Standard Deviation|Mean
640706|NCT02336607|Secondary|The Change of Pulse Wave Velocity From Baseline at 2, 14 Weeks of Felodipine Sustained Release Alone.|The duration of the combination therapy was 12 weeks. The change of pulse wave velocity was measured at week 14 of the trial.|12 weeks|The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of The change of pulse wave velocity at baseline and from at least one visit after randomization.||m/s||Standard Deviation|Mean
640707|NCT02336607|Secondary|The Change of Pulse Wave Velocity at 12 Weeks Compare With Baseline Data of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.|The duration of the combination therapy was 12 weeks. The change of pulse wave velocity was measured at week 14 of the trial.|12 weeks|The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of blood pressure at baseline and from at least one visit after randomization.||m/s||Standard Deviation|Mean
640708|NCT02336607|Secondary|The Magnitude of Systolic and Diastolic Blood Pressure Changes From Baseline Among the Subjects Who Reached Target at 12 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.|The duration of the combination therapy was 12 weeks. Blood pressure was measured at week 14 of the trial.|12 weeks|The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of blood pressure at baseline and from at least one visit after randomization.||mmHg||Standard Deviation|Mean
640709|NCT02336607|Secondary|The Magnitude of Systolic and Diastolic Blood Pressure Changes From Baseline Among the Subjects Who Reached Target After 8 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.|The duration of the combination therapy was 8 weeks. Blood pressure was measured at week 10 of the trial.|8 weeks|The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of blood pressure at baseline and from at least one visit after randomization.||mmHg||Standard Deviation|Mean
640710|NCT02336607|Secondary|The Magnitude of Systolic and Diastolic Blood Pressure Changes From Baseline Among the Subjects Who Reached Target at 4 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.|The duration of the combination therapy was 4 weeks. Blood pressure was measured at week 6 of the trial.|4 weeks|The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of blood pressure at baseline and from at least one visit after randomization.||mmHg||Standard Deviation|Mean
640711|NCT02336607|Secondary|The Magnitude of Systolic and Diastolic Blood Pressure Changes From Baseline Among All Randomized Subjects After 12 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.|The duration of the combination therapy was 12 weeks. Blood pressure was measured at week 14 of the trial.|12 weeks|The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of blood pressure at baseline and from at least one visit after randomization.||mmHg||Standard Deviation|Mean
640712|NCT02336607|Secondary|The Magnitude of Systolic and Diastolic Blood Pressure Changes From Baseline Among All Randomized Subjects After 8 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.|The duration of the combination therapy was 8 weeks. Blood pressure was measured at week 10 of the trial.|8 weeks|The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of blood pressure at baseline and from at least one visit after randomization.||mmHg||Standard Deviation|Mean
640713|NCT02336607|Secondary|The Magnitude of Systolic and Diastolic Blood Pressure Change From Baseline Among All Randomized Subjects After 4 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.|The duration of the combination therapy was 4 weeks. Blood pressure was measured at week 6 of the trial.|4 weeks|The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of blood pressure at baseline and from at least one visit after randomization.||mmHg||Standard Deviation|Mean
640714|NCT02336607|Secondary|The Percentage of Subjects Reaching Blood Pressure Target (Defined as < 140 / 90 mmHg) After 8 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.|The duration of the combination therapy was 8 weeks. Blood pressure was measured at week 10 of the trial.|8 weeks|The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of blood pressure at baseline and from at least one visit after randomization.||Percentage||95% Confidence Interval|Number
640715|NCT02336607|Secondary|The Percentage of Subjects Reaching Blood Pressure Target (Defined as < 140 / 90 mmHg) After 4 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.|The duration of the combination therapy was 4 weeks. Blood pressure was measured at week 6 of the trial.|4 weeks|The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of blood pressure at baseline and from at least one visit after randomization.||Percentage||95% Confidence Interval|Number
640716|NCT02336607|Primary|The Percentage of Subjects Reaching Blood Pressure Target (Defined as < 140 / 90 mmHg) After 14 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.||14 weeks|The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of blood pressure at baseline and from at least one visit after randomization.||Percentage||95% Confidence Interval|Number
640717|NCT02336438|Primary|Mixed Meal Testing: Difference Score: Insulin Level (μU/mL)|Difference score (trt-control) of insulin level at 60 minutes post meal.|60 minutes post-meal|||Difference score, trt-control (μU/mL)||Standard Deviation|Mean
640720|NCT02336438|Secondary|Difference Score: Percent of Time With Elevated Blood Glucose|Percent of time within hyperglycemic blood glucose range (bg>140) compared between treatment (glucomannan) and control phases, as captured by the continuous glucose monitoring device. Difference score calculated as % time with bg>140 in treatment condition minus % time with bg>140 in control condition.|10 days|||Difference score, trt-control (percent)||Standard Deviation|Mean
640721|NCT02336438|Secondary|Difference Score: Percent of Time Within Normal Blood Glucose Limits|Percent of time within normal blood glucose limits (bg 70-140) compared between treatment (glucomannan) and control phases, as captured by the continuous glucose monitoring device. Difference score calculated as % time within normal limits in treatment condition minus % time within normal limits in control condition.|10 days|||Difference score, trt-control (percent)||Standard Deviation|Mean
640722|NCT02336438|Primary|Difference Score: Percent of Time Spent in Hypoglycemic State|Percent of time within hypoglycemic blood glucose range (bg<70) compared between treatment (glucomannan) and control phases, as captured by the continuous glucose monitoring device. Difference score calculated as % time with bg<70 in treatment condition minus % time with bg<70 in control condition.|10 days|||Difference score, trt-control (percent)||Standard Deviation|Mean
640723|NCT02336425|Secondary|Response to QGE031 Between Atopic Asthma and Non-atopic Asthma||Over 52 weeks (treatment) and 20 weeks (follow up)|Due to the small number of patients randomized and limited treatment duration (not more than 22 days in QGE031 and 29 days in Placebo), the planned statistical analysis was not performed.|||||
640724|NCT02336425|Secondary|QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Total Daily Symptom Score||Over 52 weeks (Treatment) and 20 weeks (follow-up)|Due to the small number of patients randomized and limited treatment duration (not more than 22 days in QGE031 and 29 days in Placebo), the planned statistical analysis was not performed.|||||
640725|NCT02336425|Secondary|QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Peak Expiratory Flow (PEF) in the Morning and Evening||Over 52 weeks (Treatment) and 20 weeks (follow-up)|Due to the small number of patients randomized and limited treatment duration (not more than 22 days in QGE031 and 29 days in Placebo), the planned statistical analysis was not performed.|||||
640726|NCT02336425|Secondary|QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Forced Expiratory Volume in 1 Second (FEV1)||Baseline, Treatment (Weeks 4, 8, 12, 16, 24, 36, 52), follow up (Weeks 60 and 72)|Due to the small number of patients randomized and limited treatment duration (not more than 22 days in QGE031 and 29 days in Placebo), the planned statistical analysis was not performed.|||||
640727|NCT02336425|Secondary|QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Change From Baseline in Asthma Control Diary (ACD)||Over 52 weeks (Treatment) and 20 weeks (follow-up)|Due to the small number of patients randomized and limited treatment duration (not more than 22 days in QGE031 and 29 days in Placebo), the planned statistical analysis was not performed.|||||
640728|NCT02336425|Secondary|QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Change From Baseline in Asthma Control Questionnaire (ACQ)||Baseline, Treatment (Weeks 4, 8, 12, 16, 24, 36, 52), follow up (Weeks 60 and 72)|Due to the small number of patients randomized and limited treatment duration (not more than 22 days in QGE031 and 29 days in Placebo), the planned statistical analysis was not performed.|||||
640729|NCT02336425|Secondary|QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Time to First Asthma Exacerbations (by Severity)||Week 52|Due to the small number of patients randomized and limited treatment duration (not more than 22 days in QGE031 and 29 days in Placebo), the planned statistical analysis was not performed.|||||
640730|NCT02336425|Secondary|QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on the Reduction in Rate of Asthma Exacerbations (by Severity)||Week 52|Due to the small number of patients randomized and limited treatment duration (not more than 22 days in QGE031 and 29 days in Placebo), the planned statistical analysis was not performed.|||||
640731|NCT02336425|Secondary|QGE031 Compared to Placebo in Non-atopic Asthma Patients on the Reduction in Rate of Severe Asthma Exacerbations||Week 52|Due to the small number of patients randomized and limited treatment duration (not more than 22 days in QGE031 and 29 days in Placebo), the planned statistical analysis was not performed.|||||
640732|NCT02336425|Secondary|QGE031 Compared to Placebo in All Asthma Patients on the Reduction in Rate of Severe Asthma Exacerbations||Week 52|Due to the small number of patients randomized and limited treatment duration (not more than 22 days in QGE031 and 29 days in Placebo), the planned statistical analysis was not performed.|||||
640733|NCT02336425|Primary|QGE031 Compared to Placebo in Atopic Asthma Patients on the Reduction in Rate of Severe Asthma Exacerbations||Week 52|Due to the small number of patients randomized and limited treatment duration (not more than 22 days in QGE031 and 29 days in Placebo), the planned statistical analysis was not performed.|||||
640734|NCT02336178|Secondary|Percentage of Infusions With Less Than Expected Therapeutic Effects (LETEs) in Prophylaxis Setting|Less than expected therapeutic effect (LETE) in the prophylaxis setting was defined as occurrence of any spontaneous bleed within 48 hours after a regularly scheduled prophylactic dose of BeneFIX (which was not used to treat a bleed).|Up to 6 months or 50 exposure days whichever occurred first|All participants who received at least 1 dose of prophylaxis BeneFIX treatment during the study. Participants in each arm were not mutually exclusive.||percentage of infusions|Prophylaxis Infusions|95% Confidence Interval|Number
640735|NCT02336178|Secondary|Percentage of Infusions With Less Than Expected Therapeutic Effects (LETEs) in On-demand Setting|Less than expected therapeutic effect (LETE) in the on-demand setting was defined as 2 successive “no response” ratings recorded after 2 successive BeneFIX drug infusions, respectively.|Up to 6 months or 50 exposure days whichever occurred first|All participants who had a bleed during the study for which on-demand treatment with BeneFIX was administered. Participants in each arm were not mutually exclusive.||percentage of infusions|Bleeding Episodes|95% Confidence Interval|Number
640736|NCT02336178|Secondary|Average Infusion Dose and Total Factor IX Consumption in Recovery Setting|The total amount (international units [IU]) infused for each BeneFIX infusion was summed to calculate the total factor IX consumption for each participant. The average infusion dose for each participant was calculated as his total factor IX consumption (in IU) divided by the number of infusions administered.|Up to 6 months or 50 exposure days whichever occurred first|All participants who received at least 1 recovery infusion with BeneFIX during the study. Participants in each arm were not mutually exclusive.||IU||Standard Deviation|Mean
640737|NCT02336178|Secondary|Average Infusion Dose and Total Factor IX Consumption in Prophylaxis Setting|The total amount (international units [IU]) infused for each BeneFIX infusion was summed to calculate the total factor IX consumption for each participant. The average infusion dose for each participant was calculated as his total factor IX consumption (in IU) divided by the number of infusions administered.|Up to 6 months or 50 exposure days whichever occurred first|All participants who received at least 1 dose of prophylaxis BeneFIX treatment during the study. Participants in each arm were not mutually exclusive.||IU||Standard Deviation|Mean
640738|NCT02336178|Secondary|Average Infusion Dose and Total Factor IX Consumption in On-demand Setting|The total amount (international units [IU]) infused for each BeneFIX infusion was summed to calculate the total factor IX consumption for each participant. The average infusion dose for each participant was calculated as his total factor IX consumption (in IU) divided by the number of infusions administered.|Up to 6 months or 50 exposure days whichever occurred first|All participants who had a bleed during the study for which on-demand treatment with BeneFIX was administered. Participants in each arm were not mutually exclusive.||IU||Standard Deviation|Mean
640739|NCT02336178|Secondary|Number of BeneFIX Infusions to Treat Each New Bleed|The number of BeneFIX infusions administered to treat each new bleed was calculated by adding the on-demand initial treatment and any on-demand follow-up treatments for the same bleed. If there was more than one bleed location (eg, ankle and joint) with identical bleed start date and time, it was treated as one bleed occurrence.|Up to 6 months or 50 exposure days whichever occurred first|All participants who had a bleed during the study for which on-demand treatment with BeneFIX was administered. Participants in each arm were not mutually exclusive.||infusions|Bleeds|Standard Deviation|Mean
640740|NCT02336178|Secondary|Number of Infusions Resulted in the Following Response to On-demand Treatment of Bleeds: Excellent, Good, Moderate, no Response|Response was assessed using 4-point On-Demand Hemostasis Efficacy Rating Scale. Excellent means definite pain relief and/or improvement in signs of bleeding starting within 8 hours after an infusion, with no additional infusion administered; good means definite pain relief and/or improvement in signs of bleeding starting within 8 hours after an infusion, with at least one additional infusion administered for complete resolution of the bleeding episode, or definite pain relief and/or improvement in signs of bleeding starting after 8 hours following the infusion, with no additional infusion administered; moderate means probable or slight improvement starting after 8 hours following the infusion, with at least one additional infusion administered for complete resolution of the bleeding episode; no response means no improvement between infusions or during the 24 hour interval following an infusion, or condition worsens. Both first infusions and follow-up infusions were included.|Up to 6 months or 50 exposure days whichever occurred first|All participants who had a bleed during the study for which on-demand treatment with BeneFIX was administered. Participants in each arm were not mutually exclusive.||infusions|Infusions||Number
640741|NCT02336178|Secondary|Annualized Bleeding Rates (ABRs) in Participants Receiving On-demand Treatment With BeneFIX During Their On-demand Period|For on-demand period, the annualized bleeding rate (ABR) was derived for each participant by the following formula: ABR = number of bleeds in on-demand period / (number of days in on-demand period/365.25). The on-demand period was defined as the entire time of enrollment in the study (ie, from the date of the enrollment visit through the day before the Final/Early Termination visit) except time in any prophylaxis period. The breaks in the prophylaxis period were considered on-demand periods. For an on-demand regimen to have been qualified to have ABR calculated, the sum of its periods needed to be >= 14 days.|Up to 6 months or 50 exposure days whichever occurred first|All participants who received on-demand treatment during on-demand period. Participants in each arm were not mutually exclusive.||episodes/year||Standard Deviation|Mean
640742|NCT02336178|Secondary|Number of Spontaneous/Non-traumatic Breakthrough Bleeds Within 48 Hours of a Prophylaxis Dose of BeneFIX|The prophylaxis infusion time, bleed start time and bleed type (etiology) were used to determine the number of spontaneous, non-traumatic breakthrough bleeds that occurred <=48 hours after a prophylaxis infusion. If there was more than 1 bleed location (eg, ankle and joint) with identical bleed start date and time, it was treated as 1 bleed occurrence.|Up to 6 months or 50 exposure days whichever occurred first|All participants with any spontaneous/non-traumatic breakthrough bleeds within 48 hours of a prophylaxis dose. Participants in each arm were not mutually exclusive.||breakthrough bleeds|Prophylaxis Infusions with Bleeds|Standard Deviation|Mean
640743|NCT02336178|Secondary|Annualized Bleeding Rates (ABRs) in Participants Receiving Prophylaxis Treatment With BeneFIX During Their Prophylaxis Period|For prophylaxis period, annualized bleeding rate (ABR) was derived for each participant by the following formula: ABR = number of bleeds in prophylaxis period / (number of days in prophylaxis period/365.25). A prophylaxis period was defined as time from first prophylaxis infusion through 6 calendar days after the day of last prophylaxis infusion, or the day of study conclusion visit, whichever was earlier. A break in the prophylaxis period was any period of 28 days or longer in which no prophylaxis infusions were given. For a prophylaxis regimen to have been qualified to have ABR calculated, the sum of its periods needed to be >=14 days.|Up to 6 months or 50 exposure days whichever occurred first|All participants who participated in at least 1 day of a prophylaxis period (ie, had at least 1 prophylaxis dose). Participants in each arm were not mutually exclusive.||episodes/year||Standard Deviation|Mean
640744|NCT02336178|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device, regardless of the causality with the treatment or usage. A serious adverse event (SAE) was any untoward occurrence at any dose that resulted in death; was life threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. AEs included both serious and non-serious AEs. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study drug.|Up to 7 months (28 calendar days after end of 6-month or 50-exposure day study treatment)|All participants who received at least 1 dose of BeneFIX during the study. Participants in each arm were not mutually exclusive.||participants|||Number
640745|NCT02336178|Primary|Number of Participants With Thrombotic Events|Thrombotic event was defined as any event associated with formation of a blood clot including catheter-associated thrombi and thrombotic complications.|Up to 6 months|All participants who received at least 1 dose of BeneFIX during the study. Participants in each arm were not mutually exclusive.||participants|||Number
640746|NCT02336178|Primary|Number of Participants With Allergic Reactions|FIX product allergy was defined as a hypersensitivity reaction to a FIX product with symptoms such as hives, urticaria, tightness of chest, wheezing, hypotension, and anaphylaxis based on investigator’s judgments.|Up to 6 months|All participants who received at least 1 dose of BeneFIX during the study. Participants in each arm were not mutually exclusive.||participants|||Number
640747|NCT02336178|Primary|Percentage of Participants Who Developed Factor IX Inhibitor|Factor IX (FIX) inhibitor development was defined as any Bethesda inhibitor titer greater than the laboratory’s normal range or Bethesda inhibitor titer >=0.6 Bethesda Unit (BU)/mL.|Up to 6 months|All participants who received at least 1 dose of BeneFIX during the study. Participants in each arm were not mutually exclusive.||percentage of participants||95% Confidence Interval|Number
640748|NCT02335710|Primary|Kinematics During Ramp Down Activity|AR of the femur during ramp down activity|3 months post-operative|||degrees||Standard Deviation|Mean
640749|NCT02335710|Primary|Kinematics Translations During Ramp Down Activity|AP Translations of the Medial and Lateral Femoral Condyles during Ramp down activity|3 months post-operative|||mm||Standard Deviation|Mean
640750|NCT02335710|Primary|Kinematics During Ramp up Activity|AR of the femur during Ramp Up activity|3 months post-operative|||degrees||Standard Deviation|Mean
640751|NCT02335710|Primary|Kinematics Translations During Ramp up Activity|AP Translations of the Medial and Lateral Femoral Condyles During Ramp Up activity|3 months post-operative|||mm||Standard Deviation|Mean
640752|NCT02335710|Primary|Kinematics During Squat to Stand (S2S) Activity|Maximum weight-bearing flexion during squat to stand (S2S) activity Axial Rotation (AR) of the femur during S2S|3 months post-operative|||degrees||Standard Deviation|Mean
640753|NCT02335710|Primary|Kinematics Translations During Squat to Stand (S2S) Activity|Anterior Posterior (AP) translations of lateral femoral condyles during squat to stand (S2S) activity Anterior Posterior (AP) translations of medial femoral condyles during S2S|3 months post-operative|||mm||Standard Deviation|Mean
640754|NCT02335710|Primary|Kinematics During Deep Knee Bend (DKB) Activity|Maximum weight-bearing flexion during DKB Axial Rotation (AR) during DKB|3 months post-operative|||degrees||Standard Deviation|Mean
640755|NCT02335710|Primary|Kinematics Translations During Deep Knee Bend (DKB) Activity|Anterior Posterior (AP) translations of medial femoral condyles during DKB Anterior Posterior (AP) translations of lateral femoral condyles during DKB|3 months post-operative|||mm||Standard Deviation|Mean
640756|NCT02335502|Primary|Percentage of Subjects With at Least 50% Pain Reduction|Percent of subjects with at least a 50% reduction from the baseline pain VAS to the end of trial period VAS. The Visual Analog Scale (VAS) is self-administered instrument assessing average pain intensity. Subjects rated their pain on a horizontal line, 100 mm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher pain level.|Baseline and End of Trial Visit|All subjects treated with the Axium implantable neurostimulator who completed their end of trial visit.||Participants|||Count of Participants
640757|NCT02335502|Primary|Change in Pain Intensity for Overall Pain From Pre-treatment Baseline|The Visual Analog Scale (VAS) is self-administered instrument assessing average pain intensity. Subjects rated their pain on a horizontal line, 10 cm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher pain level. The values range from 0 (minimum pain) to 10 (maximum pain).|3, 6 and 12-Months|Differences in participants over time is due to early withdrawals and missing data||units on a scale||Standard Deviation|Mean
640758|NCT02335489|Primary|Change in Pain Intensity for Overall Pain From Pre-treatment Baseline|The Visual Analog Scale (VAS) is self-administered instrument assessing average pain intensity. Subjects rated their pain on a horizontal line, 10 cm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher pain level. The values range from 0 (minimum) to 10 (maximum).|Baseline, 3, 6 and12-Months|Differences in participants over time is due to early withdrawals and missing data||units on a scale||Standard Deviation|Mean
640759|NCT02334982|Secondary|Renal Clearance (CLr) for TAK-137|CLr is a measure of apparent clearance of the drug from the urine, calculated as CLr=Ae(0-t)/AUC(0-96).|Day 1|Participants from the Pharmacokinetic (PK) set, all participants who receive study drug and have at least one measureable concentration, with data available for analysis of this outcome measure.||liters/hour||Standard Deviation|Mean
640760|NCT02334982|Secondary|Fraction of TAK-137 Excreted in Urine (Fe)|Fraction of drug excreted in urine, calculated as Fe=(Ae[0-t]/dose)×100.|Day 1|Participants from the Pharmacokinetic (PK) set, all participants who receive study drug and have at least one measureable concentration, with data available for analysis of this outcome measure.||percent excreted||Standard Deviation|Mean
640761|NCT02334982|Secondary|Total Amount of Drug (TAK-137) Excreted in Urine From Time 0 to Time t (Ae[0-t])|Total amount of drug excreted in urine from time 0 to time t, calculated as Sum (Cu*Vu), where Cu is the concentration of drug excreted in urine and Vu is the volume of urine excreted.|Day 1|Participants from the Pharmacokinetic (PK) set, all participants who receive study drug and have at least one measureable concentration, with data available for analysis of this outcome measure.||mg||Standard Deviation|Mean
640762|NCT02334982|Secondary|Apparent Volume of Distribution (Vz/F) for TAK-137_101|Vz/F is the distribution of a drug between plasma and the rest of the body following oral administration, calculated as CL/F divided by λz.|Day 1|Participants from the Pharmacokinetic (PK) set, all participants who receive study drug and have at least one measureable concentration, with data available for analysis of this outcome measure.||liters||Standard Deviation|Mean
640763|NCT02334982|Secondary|Apparent Clearance (CL/F) for TAK-137_101|CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided AUC(0-inf), expressed in liters per hour (L/hr).|Day 1|Participants from the Pharmacokinetic (PK) set, all participants who receive study drug and have at least one measureable concentration, with data available for analysis of this outcome measure.||liters/hour||Standard Deviation|Mean
640764|NCT02334982|Secondary|Terminal Elimination Half-life (T1/2) for TAK-137_101|Terminal Phase Elimination Half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.|Day 1|Participants from the Pharmacokinetic (PK) set, all participants who receive study drug and have at least one measureable concentration, with data available for analysis of this outcome measure.||hours||Standard Deviation|Mean
641031|NCT02322892|Secondary|Patients With Post-operative Complications|Atrial fibrillation, delirium, renal failure, stroke, myocardial infarction, acute respiratory distress syndrome, infection|Until hospital discharge, limit 60 days|||participants|||Number
640765|NCT02334982|Secondary|AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-137|AUC(0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.|Day 1|Participants from the Pharmacokinetic (PK) set, all participants who receive study drug and have at least one measureable concentration, with data available for analysis of this outcome measure.||ng*hr/mL||Standard Deviation|Mean
640766|NCT02334982|Secondary|AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-137|(AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]).|Day 1|Participants from the Pharmacokinetic (PK) set, all participants who receive study drug and have at least one measureable concentration, with data available for analysis of this outcome measure.||ng*hr/mL||Standard Deviation|Mean
640767|NCT02334982|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-137|Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.|Day 1|Participants from the Pharmacokinetic (PK) set, all participants who receive study drug and have at least one measureable concentration, with data available for analysis of this outcome measure.||hours||Full Range|Median
640768|NCT02334982|Secondary|Cmax: Maximum Observed Plasma Concentration for TAK-137|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Day 1|Participants from the Pharmacokinetic (PK) set, all participants who receive study drug and have at least one measureable concentration, with data available for analysis of this outcome measure.||ng/mL||Standard Deviation|Mean
640769|NCT02334982|Primary|Percentage of Participants With Markedly Abnormal Vital Sign Measurements|The percentage of participants with any markedly abnormal standard vital sign measurements was collected throughout study.|Day 1 to 14 days after the last dose of study medication|Participants from the Safety population, all participants who received at least one dose of study medication, with data available for analysis. 8 of the 47 enrolled participants participated in Cohort 4 fed.||percentage of participants|||Number
640770|NCT02334982|Primary|Percentage of Participants With Abnormal Safety Laboratory Findings|The percentage of participants with any markedly abnormal standard safety laboratory values was collected throughout study.|Day 1 to 14 days after the last dose of study medication (Up to 30 Days)|Participants from the Safety population, all participants who received at least one dose of study medication, with data available for analysis. 8 of the 47 enrolled participants participated in Cohort 4 fed.||percentage of participants|||Number
640771|NCT02334982|Primary|Percentage of Participants Who Experienced at Least 1 Treatment-Emergent Adverse Event|An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event is defined as an adverse event with an onset that occurs after receiving study drug.|Day 1 to 14 days after the last dose of study medication(Up to 30 days)|Safety population included all participants who received at least one dose of study medication. 8 of the 47 enrolled participants participated in Cohort 4 fed.||percentage of participants|||Number
640772|NCT02334813|Primary|Remission Duration|Percentage of patients in ongoing remission at 6 months|6 months|||Participants|||Count of Participants
640773|NCT02334787|Secondary|AUC12h of OPA-15406 in the Multiple Administration Period|We measure the plasma concentration of OPA-15406 from Day 1 to Day 14 by applying 0.3%, 1%, or 3% formulation of OPA-15406 ointment as multiple doses twice daily for 2 weeks. We assess the AUC12h x of OPA-15406.|Baseline, 2 ,3, 4, 8, 10, 12, 16, 24 and 48 hrs at Day 14|||ng･h/mL||Standard Deviation|Mean
640774|NCT02334787|Secondary|AUC12h of OPA-15406 in a Single Administration Period|We measure the plasma concentration of OPA-15406 at Day 1 by applying 0.3%, 1%, or 3% formulation of OPA-15406 ointment as a single dose. We assess the AUC12h x of OPA-15406.|Baseline, 2 ,3, 4, 8, 10, 12, 16, 24 and 48 hrs|||ng･h/mL||Standard Deviation|Mean
640775|NCT02334787|Primary|Cmax of OPA-15406 in the Multiple Administration Period|We measure the plasma concentration of OPA-15406 from Day 1 to Day 14 by applying 0.3%, 1%, or 3% formulation of OPA-15406 ointment as multiple doses twice daily for 2 weeks. We assess the AUC12h x of OPA-15406.|Baseline, 2 ,3, 4, 8, 10, 12, 16, 24 and 48 hrs at Day 14|||ng/mL||Standard Deviation|Mean
640776|NCT02334787|Primary|Cmax of OPA-15406 in a Single Administration Period|We measure the plasma concentration of OPA-15406 at Day 1 by applying 0.3%, 1%, or 3% formulation of OPA-15406 ointment as a single dose. We assess the Cmax of OPA-15406.|Baseline, 2 ,3, 4, 8, 10, 12, 16, 24 and 48 hr|||ng/mL||Standard Deviation|Mean
640777|NCT02334267|Primary|Peridialytic Venous Blood Acetate Concentrations|Quantification of Peridialytic Venous Blood Acetate Concentrations|25, 60, 90, 120, 150, 180, 210, 240 minutes of hemodialysis|Per Protocol Population||mmol/L||Standard Deviation|Mean
640778|NCT02334267|Primary|Peridialytic Arterialized Blood Acetate Concentrations|Quantification of Peridialytic Arterialized Blood Acetate Concentrations|Immediately prior to initiation of hemodialysis, and 25, 60, 90, 120, 150, 180, 210, 240 minutes of hemodialysis and 15, 30, 45, 60, 75, and 90 minutes post hemodialysis|Per Protocol Population||mmol/L||Standard Deviation|Mean
640779|NCT02334267|Primary|Peridialytic Venous Blood Bicarbonate Concentrations|Quantification of Peridialytic Venous Blood Bicarbonate Concentrations|25, 60, 90, 120, 150, 180, 210, 240 minutes of hemodialysis|Per Protocol Population||mEq/l||Standard Deviation|Mean
640780|NCT02334267|Primary|Peridialytic Arterialized Blood Bicarbonate Concentrations|Quantification of Peridialytic Arterialized Blood Bicarbonate Concentrations|Immediately prior to initiation of hemodialysis, and 25, 60, 90, 120, 150, 180, 210, 240 minutes of hemodialysis and 15, 30, 45, 60, 75, and 90 minutes post hemodialysis|Per Protocol Population||mEq/l||Standard Deviation|Mean
640781|NCT02332902|Other Pre-specified|Determine How Orally Administered Everolimus Effects mTOR Signaling in NF-1 Tissues|Quantification via immunohistochemical staining of PTEN, pS6, p4EBP-1, TSC2, mTOR, NF-1, pAKT, VEGF-A and IGF-IR expression in biopsied neurofibroma tissue samples.|6 months||||||
640782|NCT02332902|Secondary|Number of Participants With Grade 3-4 Adverse Events|Determination if orally administered Afinitor is safe in patients a indicated by lack of Grade 3-4 adverse events during the trial period.|6 months|||Participants|||Count of Participants
640784|NCT02332798|Primary|Number of Participants With Positive Response to Columbia-Suicide Severity Rating Scale (C-SSRS)|The C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment [C-CASA]) is an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior. C-SSRS assessed whether participant experienced the following: completed suicide (1), suicide attempt (2) (response of “Yes” on “actual attempt”), preparatory acts toward imminent suicidal behavior (3)(“Yes” on “preparatory acts or behavior”), suicidal ideation (4) (“Yes” on “wish to be dead”, “non-specific active suicidal thoughts”, “active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7)(“Yes” on “Has participant engaged in non-suicidal self-injurious behavior”).|Baseline up to Day 21|The safety analysis population included all participants who received at least 1 dose of the study medication.||participants|||Number
640785|NCT02332798|Primary|Number of Participants With Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.|Baseline up to 28 days after last study drug administration|The safety analysis population included all participants who received at least 1 dose of the study medication.||participants|||Number
640786|NCT02332798|Primary|Number of Participants With Abnormalities in Physical Examination|A full physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. The brief physical examination focused on general appearance, the respiratory and cardiovascular systems, as well as towards participant reported symptoms.|Baseline up to Day 21|The safety analysis population included all participants who received at least 1 dose of the study medication.||participants|||Number
640787|NCT02332798|Primary|Number of Participants With Abnormalities in Neurological Examination|The extended neurological examination, performed by a board certified neurologist, included observation for cerebellar (intention) tremor and for non-cerebellar tremors (eg, resting or positional), finger, nose, heel, shin, Romberg, tandem walking, positional and gaze evoked nystagmus, reflexes, muscle strength, cranial nerves, sensory function of upper and lower extremities. The brief neurological examination included an assessment of motor and sensory function, cranial nerves, reflexes, non-cerebellar tremor (eg, resting or positional) and cerebellar function. The assessment of cerebellar function were complemented by the Scale for Assessment and Rating of Ataxia (SARA).|Baseline up to Day 21|The safety analysis population included all participants who received at least 1 dose of the study medication.||participants|||Number
640788|NCT02332798|Primary|Number of Participants With Electrocardiogram Data Meeting Criteria of Potential Clinical Concern|Electrocardiogram (ECG) parameters included beginning of the P wave until the beginning of the QRS complex (PR) interval, time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization (QRS) interval, and QTc using Fridericia’s formula (QTcF). Criteria for ECG changes meeting potential clinical concern included: PR interval >=300 milliseconds (msec) or >=25% increase when baseline is >200 msec and >=50% increase when baseline is less than or equal to (=<)200 msec; QRS interval >=140 msec or >=50% increase from baseline (IFB); and and QTcF >=450 to <480, 480 to <500 and >=500 msec. The number of participants with potentially clinically significant ECG findings at any visit were reported.|Baseline up to Day 21|The safety analysis population included all participants who received at least 1 dose of the study medication.||participants|||Number
640789|NCT02332798|Primary|Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern|Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: supine/sitting pulse rate less than (<) 40 or greater than (>) 120 beats per minute (bpm), standing pulse rate <40 or >140 bpm; systolic blood pressure (SBP) greater than or equal to (>=) 30 millimeters of mercury (mm Hg) change from baseline in same posture or SBP <90 mm Hg, diastolic blood pressure (DBP) >=20 mm Hg change from baseline in same posture or DBP <50 mm Hg. IFB = increase from baseline; DFB = decrease from baseline.|Baseline up to Day 21|The safety analysis population included all participants who received at least 1 dose of the study medication.||participants|||Number
640790|NCT02332798|Primary|Number of Participants With Abnormal Clinical Laboratory Measurements|The following laboratory parameters were reported: hematology (hemoglobin, hematocrit, red blood cell [RBC] count, mean corpuscular volume [MCV], mean corpuscular hemoglobin [MCH], mean corpuscular hemoglobin concentration [MCHC], platelet count, white blood cell [WBC] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen [BUN], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, alkaline phosphatase, phosphorus, cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), bicarbonate, uric acid, albumin, and total protein); urinalysis (color, appearance, specific gravity, pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, and microscopy); others (follicle stimulating hormone [FSH], and urine drug screening).|Baseline up to Day 21|The safety analysis population included all participants who received at least 1 dose of the study medication.||participants|||Number
640791|NCT02332798|Primary|Peak-to-Trough Ratio at Steady State (PTR)|PTR was calculated as Cmax divided by Cmin (that is defined as lowest concentration observed during the dosing interval). PTR steady state for PF-04958242 0.25 mg group and PF-04958242 0.475 mg group at Day 14 were presented.|Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 hours post-dose), Day 2, Day 7 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 8, Day 10, Day 14 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose)|The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters interest measured.||Ratio||Geometric Coefficient of Variation|Geometric Mean
640792|NCT02332798|Primary|Observed Accumulation Ratio for Cmax (Rac, Cmax) (Steady State)|Accumulation ratio based on Cmax was calculated as: Rac,Cmax = Cmax at steady state (ss) divided by Cmax at first dose. Rac, Cmax steady state for PF-04958242 0.25 mg group and PF-04958242 0.475 mg group at Day 14 were presented.|Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 hours post-dose), Day 2, Day 7 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 8, Day 10, Day 14 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose)|The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters interest measured.||Ratio||Geometric Coefficient of Variation|Geometric Mean
640793|NCT02332798|Primary|Observed Accumulation Ratio (Rac) (Steady State)|Accumulation ratio was calculated as, Rac obtained from Area Under the Concentration Time Curve (AUC) from time 0-t (Day X) divided by AUC from time 0-t (Day 1). Rac steady state for PF-04958242 0.25 mg group and PF-04958242 0.475 mg group at Day 14 (ie. X = 14) were presented.|Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 hours post-dose), Day 2, Day 7 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 8, Day 10, Day 14 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose)|The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters interest measured.||Ratio||Geometric Coefficient of Variation|Geometric Mean
640794|NCT02332798|Primary|Terminal Half-Life (t1/2) (Steady State)|Terminal half-life is the time measured for the plasma concentration to decrease by one half. t1/2 steady state for PF-04958242 0.25 mg group and PF-04958242 0.475 mg group at Day 14 were presented.|Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 hours post-dose), Day 2, Day 7 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 8, Day 10, Day 14 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose)|The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters interest measured.||hours||Standard Deviation|Mean
640795|NCT02332798|Primary|Apparent Volume of Distribution (Vz/F) (Steady State)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed. Vz/F steady state for PF-04958242 0.25 mg group and PF-04958242 0.475 mg group at Day 14 were presented.|Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 hours post-dose), Day 2, Day 7 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 8, Day 10, Day 14 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose)|The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters interest measured.||Liter (L)||Geometric Coefficient of Variation|Geometric Mean
640796|NCT02332798|Primary|Apparent Oral Clearance (CL/F) (Steady State)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. CL/F steady state for PF-04958242 0.25 mg group and PF-04958242 0.475 mg group at Day 14 were presented.|Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 hours post-dose), Day 2, Day 7 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 8, Day 10, Day 14 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose)|The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters interest measured.||milliliter per minute (mL/min)||Geometric Coefficient of Variation|Geometric Mean
640797|NCT02332798|Primary|AUCτ (Steady State)|AUCτ steady state for PF-04958242 0.25 mg group and PF-04958242 0.475 mg group at Day 14 were presented.|Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 hours post-dose), Day 2, Day 7 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 8, Day 10, Day 14 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose)|The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters interest measured.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
640798|NCT02332798|Primary|Area Under the Concentration-Time Profile From Time 0 to Time Tau (τ), the Dosing Interval, Where τ = 12 Hours (AUCτ) (Single Dose)||Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, and 12 hours post-dose)|The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters interest measured.||nanograms*hours per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
640799|NCT02332798|Primary|Tmax (Steady State)|Tmax steady state for PF-04958242 0.25 mg group and PF-04958242 0.475 mg group at Day 14 were presented.|Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 hours post-dose), Day 2, Day 7 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 8, Day 10, Day 14 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose)|The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters interest measured.||hours||Full Range|Median
640800|NCT02332798|Primary|Time for Cmax (Tmax) (Single Dose)||Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, and 12 hours post-dose)|The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters interest measured.||hours||Full Range|Median
640801|NCT02332798|Primary|Cmax (Steady State)|Cmax steady state for PF-04958242 0.25 mg group and PF-04958242 0.475 mg group at Day 14 were presented.|Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 hours post-dose), Day 2, Day 7 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 8, Day 10, Day 14 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose)|The PK concentration population is defined as all enrolled subjects treated who received at least one dose of PF-04958242 and have at least 1 measureable concentration.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
640802|NCT02332798|Primary|Maximum Observed Plasma Concentration (Cmax) (Single Dose)||Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, and 12 hours post-dose)|The pharmacokinetic (PK) concentration population is defined as all enrolled subjects treated who received at least one dose of PF-04958242 and have at least 1 measureable concentration.||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
640803|NCT02332590|Secondary|Measurement of Anti-Drug Antibody (ADA) Levels||Over time, maximum to Week 306||||||
640804|NCT02332590|Secondary|Clinically Significant Changes in Vital Signs||Over time, maximum to Week 306||||||
640805|NCT02332590|Secondary|Clinically Significant Changes in ECG||Over time, maximum to Week 306||||||
640806|NCT02332590|Secondary|Clinically Significant Changes in Laboratory Values: Hematology, Clinical Chemistry, and Urinalysis||Over time, maximum to Week 306||||||
640807|NCT02332590|Secondary|Number of Participants With Adverse Events||Over time, maximum to Week 306||||||
640808|NCT02332590|Secondary|Sarilumab Exposure Assessed by Trough Serum Sarilumab Concentrations||Over time, maximum to Week 306||||||
640848|NCT02331446|Other Pre-specified|Age|The number of baseline participants is not consistent with number provided in the Participant Flow module because two of the beginning participants did not arrived on the first data collection. Due to this, these participants (one of the 90 min/week, and other of the 150 min/week group) were lost to follow-up before the baseline data collection.|Week 0|||years||Inter-Quartile Range|Median
670447|NCT01700387|Secondary|Change in Number of Headache Days Reported in 30-day Baseline Period vs. Treatment Period Months 1-12||13 Months||||||
640809|NCT02332590|Secondary|Change From Baseline in Individual ACR Component- ESR Level at Week 24|ACR components were: TJC, SJC, physician global VAS, participant global VAS, pain VAS, HAQ-DI & acute phase reactant (hs-CRP and ESR levels). The ESR is a blood test that can reveal inflammatory activity. Inflammation can cause the cells to clump together. The farther the red blood cells have descended, the greater the inflammatory response. LS mean and SE at Week 24 were obtained using MMRM approach.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with ESR assessment both at baseline and Week 24.||mm/hr||Standard Error|Least Squares Mean
640810|NCT02332590|Secondary|Change From Baseline in Individual ACR Component - CRP Level at Week 24|"ACR components were: TJC, SJC, physician global VAS, participant global VAS, pain VAS, HAQ-DI & acute phase reactant (hs-CRP and ESR levels). An elevated CRP level was considered a non-specific marker for RA. A reduction level indicates improvement. LS mean and SE at Week 24 were obtained using MMRM approach."|Baseline, Week 24|ITT population. Number of participants analyzed = participants with CRP assessment both at baseline and Week 24.||mg/L||Standard Error|Least Squares Mean
640811|NCT02332590|Secondary|Change From Baseline in Individual ACR Component - Physician Global VAS, Participant Global VAS and Pain VAS at Week 24|ACR components were: TJC, SJC, physician global VAS, participant global VAS, pain VAS, HAQ-DI & acute phase reactant (hs-CRP and ESR levels). Physician global VAS & participant global VAS was done on 100 mm horizontal anchored VAS, ranging from 0 “no arthritis activity” to 100 “maximal arthritis activity” and Pain VAS on 100 mm VAS, ranging from 0 “no pain” to 100 “worst pain”. LS mean and SE at Week 24 were obtained using MMRM approach.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with individual ACR components assessment both at baseline and Week 24. Here, Number Analyzed = participants with available data for specified category for each arm, respectively.||mm||Standard Error|Least Squares Mean
640812|NCT02332590|Secondary|Change From Baseline in Individual ACR Component - TJC and SJC at Week 24|ACR components were: TJC, SJC, physician global VAS, participant global VAS, pain VAS, HAQ-DI & acute phase reactant (hs-CRP and ESR levels). 68 joints were assessed for tenderness (TJC scoring 0-68) and 66 joints for swelling (SJC scoring 0-66). The 66 SJC evaluated the following joints: temporomandibular, sternoclavicular, acromioclavicular, shoulder, elbow, wrist, metacarpophalangeal, interphalangeal of thumb, distal interphalangeal, proximal interphalangeal, knee, ankle mortise, ankle tarsus, metatarsophalangeal, interphalangeal of great toe, and proximal/distal interphalangeal of the toes. The TJC examined hip joints, in addition to the joints assessed for SJC. Increase in number of tender joints/swollen joints indicated severity. LS mean and SE at Week 24 were obtained using MMRM approach.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with TJC and SJC assessment both at baseline and Week 24.||joints||Standard Error|Least Squares Mean
640813|NCT02332590|Secondary|Change From Baseline in Morning Stiffness VAS at Week 24|RA is associated with stiffness of joints, especially in the morning after prolonged stationery state. The degree of stiffness can be an indicator of disease severity. The severity of morning stiffness was assessed on a VAS scale from 0 mm (no problem) to 100 mm (major problem). LS mean and SE at Week 24 were obtained using MMRM approach.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with morning stiffness VAS assessment both at baseline and Week 24.||mm||Standard Error|Least Squares Mean
640814|NCT02332590|Secondary|Change From Baseline in WPS-RA at Week 24: RA Interference With Household Work Productivity|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire is interviewer-administered and based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). The RA interference in the last month with household work productivity was measured on a scale that ranges from 0 (no interference) to 10 (complete interference). LS mean and SE at Week 24 were obtained using MMRM approach.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with WPS-RA: Individual items assessment both at baseline and Week 24.||units on a scale||Standard Error|Least Squares Mean
640815|NCT02332590|Secondary|Change From Baseline in WPS-RA at Week 24: Days With Outside Help Hired Due to Arthritis|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire is interviewer-administered and based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Number of days with outside help hired in the last month by the participant was reported. LS mean and SE at Week 24 were obtained using MMRM approach.|Baseline, Week 24|ITT population. Number of participants analyzed =participants with WPS-RA: Individual items assessment both at baseline and Week 24.||days||Standard Error|Least Squares Mean
640816|NCT02332590|Secondary|Change From Baseline in WPS-RA at Week 24: Days With Family/Social/Leisure Activities Missed Due to Arthritis|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire is interviewer-administered and based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Number of days missed of family/social/leisure activities in the last month by the participants was reported. LS mean and SE at Week 24 were obtained using MMRM approach.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with WPS-RA: Individual items assessment both at baseline and Week 24.||days||Standard Error|Least Squares Mean
640817|NCT02332590|Secondary|Change From Baseline in WPS-RA at Week 24: Days With Household Work Productivity Reduced by ≥ 50% Due to Arthritis|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire is interviewer-administered and based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Number of days with reduced household work productivity by ≥ 50% in the last month by the participants was reported. LS mean and SE at Week 24 were obtained using MMRM approach.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with WPS-RA: Individual items assessment both at baseline and Week 24.||days||Standard Error|Least Squares Mean
641027|NCT02322892|Other Pre-specified|Pyruvate Dehydrogenase (PDH) Enzyme Activity|PDH activity will be measured in isolated peripheral blood mononuclear cells using a novel immunocapture and microplate-based method|Six hours after end of surgery surgery||||||
640818|NCT02332590|Secondary|Change From Baseline in WPS-RA at Week 24: House Work Days Missed Due to Arthritis|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire is interviewer-administered and based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Number of days with no household work in the last month by the participants was reported. LS mean and SE at Week 24 were obtained using MMRM approach.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with WPS-RA: Individual items assessment both at baseline and Week 24.||days||Standard Error|Least Squares Mean
640819|NCT02332590|Secondary|Change From Baseline in WPS-RA at Week 24: Arthritis Interference With Work Productivity|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire is interviewer-administered and based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Interference in the last month with work productivity was measured on a scale that ranges from 0 (no interference) to 10 (complete interference). LS mean and SE at Week 24 were obtained using MMRM approach.|Baseline, Week 24|ITT Population. Number of participants analyzed = participants with WPS-RA: Individual items assessment both at baseline and Week 24.||units on a scale||Standard Error|Least Squares Mean
640820|NCT02332590|Secondary|Change From Baseline in WPS-RA at Week 24: Days With Work Productivity Reduced by ≥ 50% Due to Arthritis|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire is interviewer-administered and based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Number of work days with reduced productivity by ≥ 50% in the last month by the participants was reported. LS mean and SE at Week 24 were obtained using MMRM approach.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with WPS-RA: Individual items assessment both at baseline and Week 24.||days||Standard Error|Least Squares Mean
640821|NCT02332590|Secondary|Change From Baseline in Work Productivity Survey - Rheumatoid Arthritis (WPS-RA) at Week 24: Work Days Missed Due to Arthritis|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire is interviewer-administered and based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Number of work days missed in the last month by the participant was reported. LS mean and SE at Week 24 were obtained using MMRM approach.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with WPS-RA: Individual items assessment both at baseline and Week 24.||days||Standard Error|Least Squares Mean
640822|NCT02332590|Secondary|Change From Baseline in Rheumatoid Arthritis Impact of Disease (RAID) at Week 24|RAID is a composite measure of the impact of RA on participants that takes into account 7 domains: pain, functional disability, fatigue, physical and emotional well-being, quality of sleep, and coping. The RAID is calculated based on 7 numerical rating scales (NRS) questions. Each NRS is assessed as a number between 0 and 10 that corresponds to the 7 domains. The values for each of these domains are weighed by participant assessment of relative importance and combined in a single and calculated with a total score range of 0 (not affected, very good) to 10 (most affected). LS mean and SE at Week 24 were obtained using MMRM approach.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with RAID assessment both at baseline and Week 24.||units on a scale||Standard Error|Least Squares Mean
640823|NCT02332590|Secondary|Change From Baseline in European Quality of Life-5 Dimension 3 Level (EQ-5D-3L) Scores at Week 24|EQ-5D-3L is a standardized, generic measure of health outcome. EQ-5D was designed for self-completion by participants. EQ-5D specifically included to address concerns regarding the health economic impact of RA. EQ-5D-3L comprises of 5 questions on mobility, self-care, pain/discomfort, usual activities, and psychological status with 3 possible answers for each item (1=no problem, 2=moderate problems, 3=severe problems). The 5-dimensional 3-level systems are converted into a single index utility score between 0 to 1, where higher score indicates a better health state. EQ-5D-3L-VAS records the participant’s self-rated health on a vertical VAS that allows the participants to indicate their health state that can range from 0 (worst imaginable) to 100 (best imaginable). LS mean and SE at Week 24 were obtained using MMRM approach.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with EQ-5D-3L score assessment both at baseline and Week 24. Here, Number Analyzed = participants with available data for specified category for each arm, respectively.||units on a scale||Standard Error|Least Squares Mean
640824|NCT02332590|Secondary|Change From Baseline in CDAI at Week 24|CDAI is a composite index constructed to measure clinical remission in RA that does not include a laboratory test, and is a numerical summation of 4 components: SJC (28 joints), TJC (28 joints), participant’s global disease activity (in cm), and physician’s global assessment of disease VAS (in cm). Total score ranges from 0 to 76 with a lower score indicating less disease activity. A negative change in CDAI score indicates an improvement in disease activity and a positive change in score indicates a worsening of disease activity. LS means and SE at Week 24 were obtained using MMRM approach.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with CDAI assessment both at baseline and Week 24.||units on a scale||Standard Error|Least Squares Mean
640825|NCT02332590|Secondary|Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Remission (CDAI ≤2.8) at Week 24|CDAI is a composite index constructed to measure clinical remission in RA that does not include a laboratory test, and is a numerical summation of 4 components: SJC (28 joints), TJC (28 joints), participant’s global disease activity (in cm), and physician’s global assessment (in cm). Total score ranges from 0 to 76 with a lower score indicating less disease activity. Participants were analyzed as non-responders from the time they discontinued treatment.|Week 24|ITT population.||percentage of participants|||Number
640849|NCT02331446|Other Pre-specified|Household Income|Measured by a questionnaire and quantified by the income of all persons in the participant's home. The number of baseline participants is not consistent with number provided in the Participant Flow module because two of the beginning participants did not arrived on the first data collection. Due to this, these participants (one of the 90 min/week, and other of the 150 min/week group) were lost to follow-up before the baseline data collection.|Week 0|||US$||Inter-Quartile Range|Median
640826|NCT02332590|Secondary|Percentage of Participants Achieving Low Disease Activity (DAS28-ESR < 3.2) at Week 24|DAS28-ESR is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); GH assessment by the participant assessed from the ACR RA core set questionnaire (participant global assessment) in 100 mm VAS; Marker of inflammation assessed by ESR in mm/hr. The DAS28-ESR score provides a number indicating the current disease activity of the RA. DAS28-ESR total score ranges from 2-10. A DAS28-ESR score above 5.1 means high disease activity, DAS28-ESR score below 3.2 indicates low disease activity and DAS28-ESR score below 2.6 means disease remission. Participants were analyzed as non-responders from the time they discontinued treatment.|Week 24|ITT Population.||percentage of participants|||Number
640827|NCT02332590|Secondary|Percentage of Participants Achieving Clinical Remission Score (DAS28-CRP <2.6) at Week 24|DAS28-CRP is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); GH assessment by the participant assessed from the ACR RA core set questionnaire (participant global assessment) in 100 mm VAS; Marker of inflammation assessed by hs-CRP in mg/L. The DAS28-CRP score provides a number indicating the current disease activity of the RA. DAS28-CRP total score ranges from 2-10. A DAS28-CRP score above 5.1 means high disease activity, whereas a DAS28-CRP score below 3.2 indicates low disease activity and a DAS28-CRP score below 2.6 means disease remission. Participants were analyzed as non-responders from the time they discontinued treatment.|Week 24|ITT population.||percentage of participants|||Number
640828|NCT02332590|Secondary|Change From Baseline in Disease Activity Score for 28 Joints Based on C-Reactive Protein (DAS28-CRP Score) at Week 24|DAS28-CRP is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); GH assessment by the participant assessed from the ACR RA core set questionnaire (participant global assessment) in 100 mm VAS; Marker of inflammation assessed by high sensitivity C-reactive protein (hs-CRP) in mg/L. The DAS28-CRP score provides a number indicating the current disease activity of the RA. DAS28-CRP total score ranges from 2-10. A DAS28-CRP score above 5.1 means high disease activity, whereas a DAS28-CRP score below 3.2 indicates low disease activity and a DAS28-CRP score below 2.6 means disease remission. LS mean and SE at Week 24 were obtained using MMRM approach.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with DAS28-CRP score assessment at both baseline and Week 24.||units on a scale||Standard Error|Least Squares Mean
640829|NCT02332590|Secondary|Change From Baseline in SF-36 - Mental Health Component Summary Score at Week 24|SF-36 is a generic 36-item questionnaire consisting of 8 sub-scales, measures HRQL in the last 4 weeks covering 2 summary measures: PCS and MCS. PCS with 4 subscales: physical function, role limitations due to physical problems, pain, and general health perception; and MCS with 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same sub-scale give the sub-scale scores, which are transformed into a range from 0 to 100; 0= worst HRQL, 100=best HRQL. Both PCS and MCS range from 0-100 with higher scores indicating better physical and mental health. LS mean and SE at Week 24 by MMRM approach.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with SF-36 - mental health component summary score assessment both at baseline and Week 24.||units on a scale||Standard Error|Least Squares Mean
640830|NCT02332590|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 24|The FACIT-F is a 13-item questionnaire assessing fatigue where participants scored each item on a 5-point scale (0-4): 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much. A total score range from 0 to 52, where higher score corresponds to a lower level of fatigue. A positive change from baseline score indicates an improvement. LS mean and SE at Week 24 by MMRM approach.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with FACIT-F score assessment both at baseline and Week 24.||units on a scale||Standard Error|Least Squares Mean
640831|NCT02332590|Secondary|Change From Baseline in Short-Form-36 (SF-36) - Physical Component Summary (PCS) Score at Week 24|SF-36 is a generic 36-item questionnaire consisting of 8 sub-scales, measures health-related quality of life (HRQL) in the last 4 weeks covering 2 summary measures: PCS and mental component summary (MCS). PCS with 4 sub-scales: physical function, role limitations due to physical problems, pain, and general health perception; and MCS with 4 sub-scales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a sub-scale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same sub-scale give the sub-scale scores, which are transformed into a range from 0 to 100; 0= worst HRQL, 100=best HRQL. Both PCS and MCS range from 0-100 with higher scores indicating better physical and mental health. LS mean and SE at Week 24 by MMRM approach.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with SF-36 PCS score assessment at both baseline and Week 24.||units on a scale||Standard Error|Least Squares Mean
640832|NCT02332590|Secondary|Change From Baseline in HAQ-DI at Week 24|Physical function was assessed by HAQ-DI. It consisted of at least 2 or 3 questions per category, participant reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week rated on a 4-point scale where 0 = no difficulty; 1 = some difficulty; 2 = much difficulty; 3 = unable to do. Overall score was computed as the sum of category scores and divided by the number of categories answered, ranging from 0 to 3, where 0 = no disability and 3 = unable to do, high-dependency disability. LS mean and SE at Week 24 were obtained using MMRM approach.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with HAQ-DI assessment at both baseline and Week 24.||units on a scale||Standard Error|Least Squares Mean
640833|NCT02332590|Secondary|Percentage of Participants Achieving ACR20 Criteria at Week 24|ACR responses are assessed with a composite rating scale of the ACR that includes 7 variables: TJC (68 joints); SJC (66 joints); levels of an acute phase reactant (CRP level); participant’s assessment of pain (measured on 0 [no pain]-100 mm [worst pain] VAS); participant’s global assessment of disease activity (measured on 0 [no arthritis activity]-100 mm [maximal arthritis activity] VAS); physician’s global assessment of disease activity (measured on 0 [no arthritis activity]-100 mm [maximal arthritis activity] VAS); participant’s assessment of physical function (measured by HAQ-DI, with scoring range of 0 [better health] - 3 [worst health]). ACR20 was defined as achieving at least 20% improvement in both TJC and SJC, and at least 20% improvement in at least 3 of the 5 other assessments. Participants were analyzed as non-responders from the time they discontinued treatment.|Week 24|ITT population.||percentage of participants|||Number
640834|NCT02332590|Secondary|Percentage of Participants Achieving ACR70 Criteria at Week 24|ACR responses are assessed with a composite rating scale of the ACR that includes 7 variables: TJC (68 joints); SJC (66 joints); levels of an acute phase reactant (CRP level); participant’s assessment of pain (measured on 0 [no pain]-100 mm [worst pain] VAS); participant’s global assessment of disease activity (measured on 0 [no arthritis activity]-100 mm [maximal arthritis activity] VAS); physician’s global assessment of disease activity (measured on 0 [no arthritis activity]-100 mm [maximal arthritis activity] VAS); participant’s assessment of physical function (measured by HAQ-DI, with scoring range of 0 [better health] - 3 [worst health]). ACR70 was defined as achieving at least 70% improvement in both TJC and SJC, and at least 70% improvement in at least 3 of the 5 other assessments. Participants were analyzed as non-responders from the time they discontinued treatment.|Week 24|ITT Population.||percentage of participants|||Number
640835|NCT02332590|Secondary|Percentage of Participants Achieving ACR50 Criteria at Week 24|ACR responses are assessed with a composite rating scale of the ACR that includes 7 variables: TJC (68 joints); SJC (66 joints); levels of an acute phase reactant (C-reactive protein [CRP] level); participant’s assessment of pain (measured on 0 [no pain]-100 mm [worst pain] VAS); participant’s global assessment of disease activity (measured on 0 [no arthritis activity]-100 mm [maximal arthritis activity] VAS); physician’s global assessment of disease activity (measured on 0 [no arthritis activity]-100 mm [maximal arthritis activity] VAS); participant’s assessment of physical function (measured by Health Assessment Questionnaire - Disability Index [HAQ-DI], with scoring range of 0 [better health] - 3 [worst health]). ACR50 is defined as achieving at least 50% improvement in both TJC and SJC, and at least 50% improvement in at least 3 of the 5 other assessments of the ACR. Participants were analyzed as non-responders from the time they discontinued treatment.|Week 24|ITT Population.||percentage of participants|||Number
640836|NCT02332590|Secondary|Percentage of Participants Achieving Clinical Remission Score (DAS28-ESR <2.6) at Week 24|DAS28-ESR is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); GH assessment by the participant assessed from the ACR RA core set questionnaire (participant global assessment) in 100 mm VAS; Marker of inflammation assessed by ESR in mm/hr. The DAS28-ESR score provides a number indicating the current disease activity of the RA. DAS28-ESR total score ranges from 2-10. A DAS28-ESR score above 5.1 means high disease activity, DAS28-ESR score below 3.2 indicates low disease activity and DAS28-ESR score below 2.6 means disease remission. Participants who discontinued treatment prior to Week 24 were analyzed as non-responders.|Week 24|ITT Population.||percentage of participants|||Number
640837|NCT02332590|Primary|Change From Baseline in Disease Activity Score for 28 Joints - Erythrocyte Sedimentation Rate (DAS28-ESR) Score at Week 24|DAS28-ESR is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); General health (GH) assessment by the participant assessed from the American College of Rheumatology (ACR) rheumatoid arthritis (RA) core set questionnaire (participant global assessment) in 100 mm visual analog scale (VAS); Marker of inflammation assessed by ESR in mm/hr. The DAS28-ESR score provides a number indicating the current disease activity of the RA. DAS28-ESR total score ranges from 2-10. A DAS28-ESR score above 5.1 means high disease activity, DAS28-ESR score below 3.2 indicates low disease activity and DAS28-ESR score below 2.6 means disease remission. Least square (LS) mean and standard error (SE) at Week 24 were obtained using Mixed-effect model with repeated measures (MMRM) approach.|Baseline, Week 24|Intent-to-treat (ITT) population included all participants. Number of participants analyzed = participants with DAS28-ESR assessment at both baseline and Week 24.||units on a scale||Standard Error|Least Squares Mean
640838|NCT02331940|Secondary|Hospitalization Rate|Number of patients needed hospitalization|6 months after treatment initiation|||participants|||Number
640839|NCT02331940|Secondary|Sleepiness|Sleepiness - Epworth Sleepiness Scale (ESS) score (range 0-24, higher values indicate worse outcome, >10 indicates sleepiness, >16 excessive sleepiness)|6 months after treatment initiation|||units on a scale||Standard Deviation|Mean
640840|NCT02331940|Primary|Sleep Quality|"Sleep quality, meaning the architecture of sleep (amount of the different sleep stages across the sleep episode),consists of sleep efficiency (%) (total sleep time - TST divided by the total time in bed and multiplied by 100), REM (%TST) (rapid eye movement sleep divided by TST and multiplied by 100) and NREM (%TST) (non-rapid eye movement sleep divided by TST and multiplied by 100).
NORMAL RANGES Sleep efficiency: Normal is approximately 85 to 90% or higher. NREM (%TST): 75-80% REM (%TST) normally occupies about 20-25% of sleep time."|6 months after treatment initiation|||percentage of time||Standard Deviation|Mean
640841|NCT02331940|Primary|Sleeping Oxygen Saturation|Mean sleeping oxygen saturation (%)|6 months after treatment initiation|||percentage of Oxygen Saturation||Standard Deviation|Mean
640842|NCT02331589|Secondary|Adiponectin|enzyme-linked immunosorbent assay|3 weeks of KRG|||pg/mL||Standard Deviation|Mean
640843|NCT02331589|Secondary|Pro-inflammatory Cytokine|tumor necrosis factor-alpha, interleukin-6|3 weeks of KRG|||pg/mL||Standard Deviation|Mean
640844|NCT02331589|Secondary|Fatigue as Measured by KRUPP’s Fatigue Severity Scale|"KRUPP’s fatigue severity scale.
The survey has nine questions as following:
my motivation is lower, when I am fatigued
exercise brings on my fatigue
I am easily fatigued
fatigue interferes with my physical functioning
fatigue causes frequent problems for me
my fatigue prevents sustained physical functioning
fatigue interferes with carrying out certain duties and responsibilities
fatigue is among my 3 most disabling symptoms
fatigue interferes with my work, family, or social life. All subjects scored each question on a 7-point scale (1 = strongly disagree to 4 = neither disagree nor agree to 7 = strongly agree).
Scores range from 9 to 63, with higher scores indicating higher fatigue"|3 weeks of KRG|||scores on a scale||Standard Deviation|Mean
640845|NCT02331589|Primary|Liver Enzymes|aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, lactate dehydrogenase|3 weeks of KRG|||U/L||Standard Deviation|Mean
640846|NCT02331446|Primary|Change in Superoxide Dismutase Activity||Weeks 0, 6 and 12|||U/mg protein||Standard Deviation|Mean
640847|NCT02331446|Other Pre-specified|Chronic Use of Medication|Measured by a questionnaire and quantified categorically in: No; Yes. This variable refers to a chronic use of any medication. The number of baseline participants is not consistent with number provided in the Participant Flow module because two of the beginning participants did not arrived on the first data collection. Due to this, these participants (one of the 90 min/week, and other of the 150 min/week group) were lost to follow-up before the baseline data collection.|Week 0|||participants|||Number
641028|NCT02322892|Other Pre-specified|Lactate Levels||Six hours after end of surgery surgery||||||
640850|NCT02331446|Other Pre-specified|Educational Level|Measured by a questionnaire and quantified categorically in: Incomplete primary school; Primary school; Incomplete high school; High school; Incomplete higher education; Higher education. The number of baseline participants is not consistent with number provided in the Participant Flow module because two of the beginning participants did not arrived on the first data collection. Due to this, these participants (one of the 90 min/week, and other of the 150 min/week group) were lost to follow-up before the baseline data collection.|Week 0|||participants|||Number
640851|NCT02331446|Other Pre-specified|Change in Calories Intake|Measured by a 24-hour food recall and quantified in calories|Weeks 0 and 12|||cal||Standard Deviation|Mean
640852|NCT02331446|Other Pre-specified|Change in Minutes Per Week of Physical Activity Out of Intervention|Measured by the commuting and leisure sections of the International Physical Activity Questionnaire|Week 0 and 12|||minutes per week||Inter-Quartile Range|Median
640853|NCT02331446|Other Pre-specified|Change in Body Mass Index||Weeks 0 and 12|||kg/m²||Inter-Quartile Range|Median
640854|NCT02331446|Secondary|Change in Handgrip Strength|Measured using a handgrip dynamometer and quantified in kilogram-force|Weeks 0 and 12|||kgf||Standard Deviation|Mean
640855|NCT02331446|Secondary|Change in Performance in the Six-minute Walk Test||Weeks 0 and 12|||Meters||Standard Deviation|Mean
640856|NCT02331446|Primary|Change in Glutathione Peroxidase Activity||Weeks 0, 6 and 12|||U/mg protein||Standard Deviation|Mean
640857|NCT02331446|Primary|Change in Total Thiol Content||Weeks 0, 6 and 12|||nmol TNB/mg protein||Standard Deviation|Mean
640858|NCT02331446|Primary|Change in Thiobarbituric Acid Reactive Substances||Weeks 0, 6 and 12|||nmol TBARS/mg protein||Standard Deviation|Mean
640859|NCT02331446|Primary|Change in Butyrylcholinesterase Activity||Weeks 0, 6 and 12|||µmol BuSCh/h/mg of protein||Standard Deviation|Mean
640860|NCT02331446|Primary|Change in Adenosine Deaminase Activity||Weeks 0, 6 and 12|||U/L||Standard Deviation|Mean
640861|NCT02331446|Primary|Change in Interleukin-6||Weeks 0, 6 and 12|||pg/mL||Inter-Quartile Range|Median
640862|NCT02331108|Secondary|Measurement of Blood Pressure|Blood pressure decrease after intravenous anesthetic induction|intraoperative|Percentage of patients whose blood pressure decreased after propofol administration||percentage of patients|||Number
640863|NCT02331108|Primary|Temperature Below 36.0 Degrees C|Percentage of patients who had at least one temperature below 36.0 degrees C in the first hour of anesthesia|Intraoperative|Percentage of patients who had one core temperature reading below 36.0 degree C in the first hour of anesthesia||Percentage|||Number
640864|NCT02331108|Primary|Measurement of Core Temperature|Core temperature at 15 minute intervals|intraoperative|||degree C||Standard Deviation|Mean
640865|NCT02330588|Secondary|Parents' Concern About Children's Weight Status and Motivation to Change Lifestyle Behaviors Immediately Following the SBIRT.|"A brief, eight-item Likert scale questionnaire with established face validity has been adopted from Campbell et al. (2011) and will assess parents’ concern for and motivation to support their child’s lifestyle behaviors. Concern and motivation to change were measured on a 5-point Likert scale ('strongly disagree' [0] to 'strongly agree' [4]); for example, I am ready to change my child's lifestyle behaviors, a 0 would indicate that participants strongly disagree with this statement."|Measured at baseline|||units on a scale (0 to 4 Likert Scale)||95% Confidence Interval|Mean
640866|NCT02330588|Primary|Feasibility (Parents' Uptake of the SBIRT)|Parents' uptake was determined by parents’ use (actual and self-reported) of obesity prevention resources (i.e., the proportion [reported in percentage] that actually or self-reported using resources out of the total number of participants that participated in follow-up), and the proportion (reported in percentage) of parents that reported discussing children’s weight with their pediatrician immediately following the SBIRT.|One-month follow-up|Participants who completed one-month follow-up.||percentage of participants|||Number
640867|NCT02330588|Primary|Feasibility (Parents’ Interest in the SBIRT.)|Parents' interest was determined by the proportion (indicated as a percentage) of parents that (i) enrolled among those approached to participate, (ii) ‘opted in’ to receive the tailored email report, and (iii) self-selected resources from the SBIRT; the latter two were recorded by back-end programming of the SBIRT.|Baseline|Parents who participated at baseline.||percentage of parents|||Number
640868|NCT02330523|Secondary|Wound Closure at 4-weeks|Suture line gap will be measured (buccal-lingual) with a UNC-15 Probe, rounding down to the nearest 0.5 mm.|4-weeks|||mm||Standard Deviation|Median
640869|NCT02330523|Secondary|New Bone Plus Graft Content at 6-months|"New bone and graft content are measured as histomorphometric % vital bone and % mineral (graft remnants) from mid-section bone core biopsies. Histomorphometric analyses are performed with imaging software on composite overview scans. The area of new healing (versus old/ original bony tissues) is demarcated in each section. Within this area, the percentage contributions of each tissue type within the overall area of newly healed tissue is computed, i.e., new bone plus graft content added with connective tissue/ marrow elements totals 100% of the new healing area."|Six Months|||percentage of total area||Standard Deviation|Mean
640870|NCT02330523|Primary|Bone Ridge Buccal-Lingual and Apico-Coronal Measures at 6 Months|The primary efficacy parameter will be ridge volume preservation as measured apico-coronal and buccal-lingual using a preformed and marked stent.|Six Months|||mm||Standard Deviation|Mean
640871|NCT02330276|Secondary|Change From Baseline in Circulating C-Peptide Concentrations (ng/mL*24hr)||Baseline and 24 hours|Intent to treat population (all participants who receive the medication). Last observation carried forward (LOCF) imputation method.||ng/mL*24hr||Standard Deviation|Mean
640872|NCT02330276|Secondary|Change From Baseline in Circulating Insulin Concentrations (uU/mL*24hr)||Baseline and 24 hours|Intent to treat population (all participants who receive the medication). Last observation carried forward (LOCF) imputation method.||uU/mL*24 hr||Standard Deviation|Mean
640873|NCT02330276|Secondary|Change From Baseline in Circulating Glucose Concentrations (mg/dL*24hr)||Baseline and 24 hours|Intent to treat population (all participants who receive the medication). Last observation carried forward (LOCF) imputation method.||mg/dL*24hr||Standard Deviation|Mean
640874|NCT02330276|Secondary|Change From Baseline in Major Safety Endpoints|Clinically significant differences in the major safety endpoints are defined as: BP (10 mm Hg change), HR (10 bpm), creatinine (>1.5 ULN), and highly conservative changes in alkaline phosphatase and liver transaminases (>1.5 ULN).|Baseline and 24 hours|Intent to treat population (all participants who receive the medication). Last observation carried forward (LOCF) imputation method.||participants|||Number
640875|NCT02330276|Primary|Change From Baseline in Circulating Urinary Concentrations of Intact Epicatechin and Epi Metabolites|This will be initial PK study on synthetic (+)-epicatechin in humans. Circulating and urinary concentrations of intact epicatechin and epicatechin metabolites, including specific enantiomers|Baseline and 24 hours|Intent to treat population (all participants who receive the medication). Last observation carried forward (LOCF) imputation method.||nM*hr||Standard Deviation|Mean
640876|NCT02330172|Secondary|Recovery Time From Neuromuscular Blockade|We measured recovery time ffrom the injection of neostigmine or sugammadex to TOF ratio 0.9|from the injection of neostigmine or sugammadex up to 30 minutes|||minute||Standard Deviation|Mean
640877|NCT02330172|Primary|Laryngoscopic Score|"Definitions for evaluation of Laryngoscopycondition.
: Easy = jaw relaxed, no resistance to blade insertion, fair = jaw not fully relaxed, slight resistance to blade insertion, difficult = poor jaw relaxation, active resistance of the patient to laryngoscopy.
Variables Excellent Good Poor"|At the beginning of surgery, the surgeon rated the laryngoscopy condition|"Definitions for evaluation of Laryngoscopycondition.
: Easy = jaw relaxed, no resistance to blade insertion, fair = jaw not fully relaxed, slight resistance to blade insertion, difficult = poor jaw relaxation, active resistance of the patient to laryngoscopy.
Variables Excellent Good Poor"||Participants|||Count of Participants
640878|NCT02329964|Secondary|Time to Eye Opening|We expected the emergence time is shorter in R-S group than S-C-N group. So we measure the time from the end of surgery to opening of the eyes to verbal commands.|from end of surgery to opening of the eyes to verbal commands|||seconds||Inter-Quartile Range|Median
640879|NCT02329964|Secondary|Time to First Spontaneous Breath|time from end of surgery to first spontaneous breaths|from end of surgery to first spontaneous breaths|||seconds||Inter-Quartile Range|Median
640880|NCT02329964|Primary|Recovery of T1 to 10%|we measure the time from the end of surgery to recovery of the TOF 0.1. The end of surgery is defined as the time when the direct laryngoscope, aided by an operation microscope, is removed.|from the end of surgery to time when the TOF ratio is 0.1, up to 30 minutes|||seconds||Inter-Quartile Range|Median
640881|NCT02329964|Other Pre-specified|Anesthesia Time|time from propofol injection to extubation|from the anesthesia start to end|||minutes||Standard Deviation|Mean
640882|NCT02329964|Other Pre-specified|Length of Stay in te Operating Room|LMS surgery has short operation time and ambulatory setting. So the length of stay in the operating room will have significant. We expected the lengh of stay in the operating room is more shorter in R-S group than S-C-N group.|time from in to out of the operating room|||minutes||Standard Deviation|Mean
640883|NCT02329964|Secondary|Time to Extubation|We expected the emergence time is shorter in R-S group than S-C-N group. So we measure the time from the end of surgery to recovery of the TOF 0.9, and the time from the end of surgery to extubation|from the end of surgery to extubate a tracheal tube|||seconds||Inter-Quartile Range|Median
640884|NCT02329964|Primary|Addition of Neuromuscular Blocking Agents|"Repeated small boluses or drip of Succinylcholine, or small boluses of nondepolarizing muscle relaxants with intermediate duration are usually followed.
In this protocol, cisatracurium was injected after intubation to maintain neuromuscular blockade during surgery.
We measure the requirement of additive dose of neuromuscular blocker to ensure that neuromuscular blockade remains below T2 during surgery"|during surgery|||participants|||Number
640885|NCT02329964|Primary|Surgical Rating Score|"describe by surgeon under his subjective opinion.
1 - extremely poor conditions 2- poor conditions 3- acceptable conditions 4- good conditions 5- optimal conditions"|during surgery|||score||Inter-Quartile Range|Median
640886|NCT02329964|Primary|Recovery of T1 to 90%|we measure the time from the end of surgery to recovery of the TOF 0.9. The end of surgery is defined as the time when the direct laryngoscope, aided by an operation microscope, is removed.|from the end of surgery(when the surgeon removes the suspension laryngoscope ) to time when the TOF ratio is 0.9, up to 30 minutes|||seconds||Inter-Quartile Range|Median
640887|NCT02329730|Primary|Number of Tuberculosis (TB) Participants Positive for Reaction at 96 Hours After Intradermal Injection With ESAT6-CFP10|The investigators measure the longitudinal diameter and transverse diameter of induration and/or redness of ESAT6-CFP10 in TB participants at 96 hours after intradermal injection by vernier caliper . And at the same blisters and lymphangitis are the specificity of the positive reaction of ESAT6-CFP10 .So induration ,redness ,blisters and lymphangitis in the participants' arm are positive reaction.|96 hours after intradermal injection|The percentage of positive(positive number/total number*100%) is the sensitivity of ESAT6-CFP10 .||participants|||Number
640888|NCT02329730|Primary|Number of Healthy Participants Negative for Reaction at 96 Hours After Intradermal Injection With ESAT6-CFP10|The investigators measure the longitudinal diameter and transverse diameter of induration and/or redness of ESAT6-CFP10 in healthy participants at 96 hours after intradermal injection by vernier caliper . And at the same blisters and lymphangitis are the specificity of the positive reaction of ESAT6-CFP10 .So induration ,redness ,blisters and lymphangitis in the healthy participants' arm are positive reaction.|96 hours after intradermal injection|The percentage of negative(negative number/total number*100%) is the specificity of ESAT6-CFP10 .||participants|||Number
640889|NCT02329730|Primary|Number of Tuberculosis (TB) Participants Positive for Reaction at 72 Hours After Intradermal Injection With ESAT6-CFP10|The investigators measure the longitudinal diameter and transverse diameter of induration and/or redness of ESAT6-CFP10 in TB participants at 72 hours after intradermal injection by vernier caliper . And at the same blisters and lymphangitis are the specificity of the positive reaction of ESAT6-CFP10 .So induration ,redness ,blisters and lymphangitis in the participants' arm are positive reaction.|72 hours after intradermal injection|The percentage of positive(positive number/total number*100%) is the sensitivity of ESAT6-CFP10 .||participants|||Number
640890|NCT02329730|Primary|Number of Healthy Participants Negative for Reaction at 72 Hours After Intradermal Injection With ESAT6-CFP10|"The investigators measure the longitudinal diameter and transverse diameter of induration and/or redness of ESAT6-CFP10 in healthy participants at 72 hours after intradermal injection by vernier caliper . And at the same blisters and lymphangitis are the specificity of the positive reaction of ESAT6-CFP10 .So induration ,redness ,blisters and lymphangitis in the healthy participants' arm are positive reaction.
The percentage of negative(negative number/total number*100%) is the specificity of ESAT6-CFP10"|72 hours after intradermal injection|||participants|||Number
640950|NCT02327429|Primary|Change in Calcium Intake (3-day Food Record)|Intake assessed pre-post intervention using a 3-day food record from baseline to 3 months|12 weeks|||milligrams||Standard Deviation|Mean
640891|NCT02329730|Primary|Number of Tuberculosis (TB) Participants Positive for Reaction at 48 Hours After Intradermal Injection With ESAT6-CFP10|The investigators measure the longitudinal diameter and transverse diameter of induration and/or redness of ESAT6-CFP10 in TB participants at 48 hours after intradermal injection by vernier caliper . And at the same blisters and lymphangitis are the specificity of the positive reaction of ESAT6-CFP10 .So induration ,redness ,blisters and lymphangitis in the participants' arm are positive reaction.|48 hours after intradermal injection|The percentage of positive(positive number/total number*100%) is the sensitivity of ESAT6-CFP10.||participants|||Number
640892|NCT02329730|Primary|Number of Healthy Participants Negative for Reaction at 48 Hours After Intradermal Injection With ESAT6-CFP10|The investigators measure the longitudinal diameter and transverse diameter of induration and/or redness of ESAT6-CFP10 in healthy participants at 48 hours after intradermal injection by vernier caliper . And at the same blisters and lymphangitis are the specificity of the positive reaction of ESAT6-CFP10 .So induration ,redness ,blisters and lymphangitis in the healthy participants' arm are positive reaction.|48 hours after intradermal injection|The percentage of negative(negative number/total number*100%) is the specificity of ESAT6-CFP10 .||participants|||Number
640893|NCT02329730|Primary|Number of Tuberculosis (TB) Participants Positive for Reaction at 24 Hours After Intradermal Injection With ESAT6-CFP10|The investigators measure the longitudinal diameter and transverse diameter of induration and/or redness of ESAT6-CFP10 in TB participants at 24 hours after intradermal injection by vernier caliper . And at the same blisters and lymphangitis are the specificity of the positive reaction of ESAT6-CFP10 .So induration ,redness ,blisters and lymphangitis in the participants' arm are positive reaction.|24 hours after intradermal injection|The percentage of positive(positive number/total number*100%) is the sensitivity of ESAT6-CFP10 .||participants|||Number
640894|NCT02329730|Secondary|the Number of Tuberculosis (TB) Participants Positive for IFN-γ(Gamma Interferon ) at 144 Hours After Intradermal Injection With ESAT6-CFP10|The investigator draw 5ml venous blood for detection of IFN-γ 144 hours before injection with drug.The percentage of positive(positive number/total number*100%) is the sensitivity of IFN-γ in in TB participants.|144 hours after injection|||participants|||Number
640895|NCT02329730|Secondary|the Number of Healthy Participants Negative for IFN-γ(Gamma Interferon ) at 144 Hours After Intradermal Injection With ESAT6-CFP10|The investigator draw 5ml venous blood for detection of IFN-γ 144 hours after injection with drug.The percentage of negative(negative number/total number*100%) is the specificity of IFN-γ in healthy participants.|144 hours after injection|||participants|||Number
640896|NCT02329730|Secondary|the Number of Tuberculosis (TB) Participants Positive for IFN-γ(Gamma Interferon ) at 72 Hours After Intradermal Injection With ESAT6-CFP10|The investigator draw 5ml venous blood for detection of IFN-γ 72 hours after injection with drug.The percentage of positive(positivenumber/total number*100%) is the sensitivity of IFN-γ in in TB participants.|72 hours after injection|||participants|||Number
640897|NCT02329730|Secondary|the Number of Healthy Participants Negative for IFN-γ(Gamma Interferon ) at 72 Hours After Intradermal Injection With ESAT6-CFP10|The investigator draw 5ml venous blood for detection of IFN-γ four hours before injection with drug.The percentage of negative(negative number/total number*100%) is the specificity of IFN-γ in healthy participants.|72 hours after injection|||participants|||Number
640898|NCT02329730|Secondary|the Number of Tuberculosis (TB) Participants Positive for IFN-γ(Gamma Interferon ) Before Injection|The investigator draw 5ml venous blood for detection of IFN-γ four hours before injection with drug. The percentage of positive(positive number/total number*100%) is the sensitivity of IFN-γ in TB Participants.|4 hours before injection and after signed ICF(informed consent forms)|||participants|||Number
640899|NCT02329730|Secondary|the Number of Healthy Participants Negative for IFN-γ(Gamma Interferon ) Before Injection|The investigator draw 5ml venous blood for detection of IFN-γ four hours before injection with drug.The percentage of negative(negative number/total number*100%) is the specificity of IFN-γ in healthy participants.|before injection and after signed ICF(informed consent forms)|||participants|||Number
640900|NCT02329730|Secondary|the Number of Participants With Adverse Events|"evaluate specific time point of vital signs, skin test reaction, blood routine, urine routine, liver and kidney function, electrocardiogram and adverse events as the incidence of adverse events in the participants .
Skin test reaction observation time: at the end of the skin test, skin test after 15 minutes, 1 hour, 4 hours, 24 hours, 48 hours, 72 hours, 96 hours; Vital signs evaluation time: 0 minutes before the subjects were intradermal injection, intradermal injection after 15 minutes, 1 hour, 4 hours, 24 hours, 48 hours, 72 hours, 96 hours, 144 hours.
Blood routine, urine routine, liver and kidney function, electrocardiogram (ecg) evaluation time: skin test before and 144 h after injection; adverse events evaluation time: participants signed a written informed consent to finish all the follow-up."|before injection to 144 hours (plus or minus 2 hours) after injection|||participants|||Number
640901|NCT02329730|Primary|Number of Healthy Participants Negative for Reaction at 24 Hours After Intradermal Injection With ESAT6-CFP10|"The investigators measure the longitudinal diameter and transverse diameter of induration and/or redness of ESAT6-CFP10 in healthy participants at 24 hours after intradermal injection by vernier caliper . And at the same blisters and lymphangitis are the specificity of the positive reaction of ESAT6-CFP10 .So induration ,redness ,blisters and lymphangitis in the healthy participants' arm are positive reaction.
The percentage of negative(negative number/total number*100%) is the specificity of ESAT6-CFP10 ."|24 hours after intradermal injection|The percentage of negative(negative number/total number*100%) is the specificity of ESAT6-CFP10 .||participants|||Number
640902|NCT02329600|Secondary|Salivary Total Oxidative Capacity|total oxidative capacity was assessed in whole unstimulated saliva by ezyme-linked immunosorbent assay (umol/L) at 1 month after treatment|one month after treatment|||umol/L||Standard Deviation|Mean
640903|NCT02329600|Primary|Pain|pain was assessed by visual analogue scale (1-10) 1 indicates better and 10 worse, 1 month after treatment|one month after treatment|||units on a scale||Standard Deviation|Mean
640904|NCT02329431|Secondary|Child Visit No-shows Over 4 Months|We collected child attendance at clinic visits during a 4-month window of time, during the 3-month period parents were participating in the study and one additional month following. Child clinic visit no-shows were measured by number of visits missed.|baseline to 4-month follow-up|Target child with any scheduled visits||visits||Standard Deviation|Mean
640951|NCT02327429|Primary|Change in Sodium Intake (3-day Food Record)|Intake assessed pre-post intervention using a 3-day food record from baseline to 3 months|12 weeks|||milligrams||Standard Deviation|Mean
640905|NCT02329431|Secondary|Number of Clinic Visits Child Attended Over 4 Months|We collected child attendance at clinic visits during a 4-month window of time, during the 3-month period parents were participating in the study and one additional month following. Child clinic visit attendance was measured by number of visits attended.|baseline to 4-month follow-up|Target child with any scheduled clinic visits||visits||Standard Deviation|Mean
640906|NCT02329431|Secondary|Parent Activation, Qualitative|We collected qualitative data on parent-provider communication after completion of the 4-week MePrEPA (metas, preguntar, escuchar, preguntar para aclarar/goals, questioning, listening, questioning to clarify) and parent support groups, in an effort to capture observed activation. We coded when the parent disagreed with therapist and when the parent mentioned speaking with child's teacher.|1 month|Completed baseline interview and had an audio-recorded visit||Participants|||Count of Participants
640907|NCT02329431|Secondary|Parental Stress Scale|Parent stress was measured with the 17-item Parental Stress Scale. The Parental Stress Scale is scored on a scale from 0 to 75, where higher scores reflect greater stress. It has been translated into Spanish, and has been shown to have excellent validity and reliability (for women, mean=22).|1 and 3 months|Completed a baseline interview||scores on a scale||Standard Deviation|Mean
640908|NCT02329431|Secondary|8-item Patient Health Questionnaire (PHQ-8)|Parent depression was measured with the 8-item Patient Health Questionnaire (PHQ-8). The PHQ-8 is scored on a scale from 0 to 27; a higher score reflects greater severity of depression. It has excellent validity and reliability. The parent PHQ-9 has been translated into Spanish and used successfully in Latina/o populations. A change of 5 points in the PHQ-8 is associated with a shift in level of depression.|1 and 3 months|Completed a baseline interview||scores on a scale||Standard Deviation|Mean
640909|NCT02329431|Primary|Patient Activation Measure|The Patient Activation Measure (PAM) captured parent activation on behalf of their child. The PAM is an adult self-report 13-item scale with 4-level Likert responses and scores ranging from 0 to 100. Higher scores indicate higher activation. It is valid with excellent reliability. The PAM has been translated into Spanish and has been used successfully in Latina/o patient and general populations (mean=40). The PAM has also been used to measure activation of parents on behalf of their children (mean=70). A change of 4 points in the PAM is associated with improved health behaviors in the general population.|1 and 3 months|Completed a baseline interview||scores on a scale||Standard Deviation|Mean
640910|NCT02329223|Secondary|Percentage of Participants With Production of Anti-omalizumab Antibody|Serum samples were collected for anti-omalizumab antibody testing.|Week 24|The safety analysis set, which included all participants who received their assigned study treatment, were considered for the analysis. Only participants, who had antibody results (conclusive or inconclusive), were analyzed.||Percentage of participants|||Number
640911|NCT02329223|Secondary|Change From Baseline in the Overall Dermatology Life Quality Index (DLQI) Score at Week 12|The DLQI is a 10-item dermatology-specific health-related quality of life measure. Participants rated their dermatology symptoms as well as the impact of their skin condition on various aspects of their lives on a scale of 0 (Not at all) to 3 (Very much). The overall DLQI is the sum of the responses to the 10 items and ranges from 0 to 30. A lower score indicates a better quality of life. A negative change score from baseline indicates improvement.|Baseline to Week 12|Only participants from the FAS, who were greater than age 16, were analyzed. The Full Analysis Set (FAS) was analyzed. The FAS included all participants who were diagnosed with chronic spontaneous urticaria (CSU) and received the assigned study treatment.||Units on a scale||Standard Error|Least Squares Mean
640912|NCT02329223|Secondary|Percentage of Complete Responders (UAS7 = 0) at Week 12|Complete responders are defined as participants who achieved UAS7 = 0.|Week 12|The Full Analysis Set (FAS) was analyzed. The FAS included all participants who were diagnosed with chronic spontaneous urticaria (CSU) and received the assigned study treatment.||Percentage of participants|||Number
640913|NCT02329223|Secondary|Percentage of Weekly Itch Severity Score Minimally Important Difference (MID) Responders at Week 12|Weekly itch severity score MID response is defined as a reduction from baseline in weekly itch severity score of ≥ 5 points.|Week 12|The Full Analysis Set (FAS) was analyzed. The FAS included all participants who were diagnosed with chronic spontaneous urticaria (CSU) and received the assigned study treatment.||Percentage of participants|||Number
640914|NCT02329223|Secondary|Change From Baseline in the Weekly Size of the Largest Hive Score at Week 12|The weekly size of the largest hive score is the sum of the daily size of the largest hive scores over 7 days and ranges from 0 to 21. The daily size of the largest hive score is assessed twice daily (morning and evening) on a scale of 0 (none) to 3 (> 2.5 cm). The daily size of the largest hive score is the average of the morning and evening scores. The Baseline weekly size of the largest hive score is calculated over the 7 days prior to the first treatment. A higher score indicates larger hives. A negative change score from baseline indicates a reduction in hive size.|Baseline to Week 12|The Full Analysis Set (FAS) was analyzed. The FAS included all participants who were diagnosed with chronic spontaneous urticaria (CSU) and received the assigned study treatment.||Units on a scale||Standard Error|Least Squares Mean
640915|NCT02329223|Secondary|Percentage of Participants With a UAS7 Score ≤ 6 at Week 12|The UAS7 is a composite score of the number of wheals (hives) and the severity of the itch. The UAS7 is determined by the sum of the daily urticaria activity scores over 7 days and ranges from 0 to 42. The daily urticaria activity score is the average of the morning and evening urticaria activity scores and ranges from 0 to 6. The urticaria activity score is the sum of ratings on a scale of 0 to 3 (0=none to 3=intense/severe) for (1) the number of wheals (hives) and (2) itch intensity over the previous 12 hours, ranges from 0 to 6, and is measured twice daily (morning and evening). The Baseline score is the sum of the daily urticaria activity scores over the 7 days prior to the first treatment. A higher urticaria activity score indicates more severe symptoms.|Week 12|The Full Analysis Set (FAS) was analyzed. The FAS included all participants who were diagnosed with chronic spontaneous urticaria (CSU) and received the assigned study treatment.||Percentage of participants|||Number
640952|NCT02327429|Primary|Change in Added Sucrose Intake (3-day Food Record)|Intake assessed pre-post intervention using a 3-day food record|12 weeks|||percentage of total energy||Standard Deviation|Mean
640953|NCT02327429|Primary|Change in Dietary Fibre Intake (3-day Food Record)|Intake assessed pre-post intervention using a 3-day food record|12 weeks|||grams||Standard Deviation|Mean
640954|NCT02327429|Primary|Change in Saturated Fat Intake (3-day Food Record)|Intake assessed pre-post intervention using a 3-day food record|12 weeks|||percentage of total energy||Standard Deviation|Mean
640916|NCT02329223|Secondary|Change From Baseline in the Weekly Number of Hives Score at Week 12|The weekly hives score is the sum of the daily hives scores over 7 days and ranges from 0 to 21. The number of hives is measured twice daily (morning and evening) on a scale of 0 (none) to 3 (> 12 hives per 12 hours). The daily hives score is the average of the morning and evening scores. The Baseline score is the sum of the daily hives scores over the 7 days prior to the first treatment. A higher score indicates more hives. A negative change score indicates improvement.|Baseline to Week 12|The Full Analysis Set (FAS) was analyzed. The FAS included all participants who were diagnosed with chronic spontaneous urticaria (CSU) and received the assigned study treatment.||Units on a scale||Standard Error|Least Squares Mean
640917|NCT02329223|Secondary|Change From Baseline in the Urticaria Activity Score Over 7 Days (UAS7) at Week 12|The UAS7 is a composite score of the number of wheals (hives) and the severity of the itch. The UAS7 is determined by the sum of the daily urticaria activity scores over 7 days and ranges from 0 to 42. The daily urticaria activity score is the average of the morning and evening urticaria activity scores and ranges from 0 to 6. The urticaria activity score is the sum of ratings on a scale of 0 to 3 (0=none to 3=intense/severe) for (1) the number of wheals (hives) and (2) itch intensity over the previous 12 hours, ranges from 0 to 6, and is measured twice daily (morning and evening). The Baseline score is the sum of the daily urticaria activity scores over the 7 days prior to the first treatment. A higher urticaria activity score indicates more severe symptoms. A negative change score from baseline indicates improvement.|Baseline to Week 12|The Full Analysis Set (FAS) was analyzed. The FAS included all participants who were diagnosed with chronic spontaneous urticaria (CSU) and received the assigned study treatment.||Units on a scale||Standard Error|Least Squares Mean
640918|NCT02329223|Primary|Change From Baseline in the Weekly Itch Severity Score at Week 12|The weekly itch severity score is a component of the Urticaria Activity Score 7 (UAS7) composite score. The UAS7 is a composite score of the number of wheals (hives) and the severity of the itch. The weekly itch severity score is the sum of the daily itch severity scores over 7 days and ranges from 0 to 21. The daily itch severity score is the average of the morning and evening scores on a scale of 0 (none) to 3 (severe). The Baseline weekly itch severity score is the sum of the daily itch severity scores over the 7 days prior to the first treatment. A higher itch severity score indicates more severe itching. A negative change score from baseline indicates improvement.|Baseline to Week 12|The Full Analysis Set (FAS) was analyzed. The FAS included all participants who were diagnosed with chronic spontaneous urticaria(CSU) and received the assigned study treatment.||Units on a scale||Standard Error|Least Squares Mean
640919|NCT02329015|Other Pre-specified|Teacher Report Behavior Rating Inventory of Executive Function|Teacher reported 87 item questionnaire on students executive function and self regulation. The BRIEF for teachers measures 8 non-overlapping theoretically and empirically derived clinical scales that measure different aspects of executive functioning with the Inhibit, Shift, Emotional control and Monitor subscales combining to create a Behavioral Regulation Index (BRI) and the Working Memory, Plan/Organize, Organization of Materials and Task Completion combining to create a Meta Cognition Index. These two indices combine to create a Global Executive Composite (GEC). Only the GEC was used within this study for analysis Raw scores were converted to T scores (using gender and age for population norms) wherein a score of 50 represents the mean and a difference of 10 from the mean indicates a difference of one standard deviation.|One year|3 subjects missing from experimental group and 5 subjects missing from comparison group||units on a scale||Standard Deviation|Mean
640920|NCT02329015|Other Pre-specified|Student Self-Report Behavior Rating Inventory of Executive Function|An 80 item self-report questionnaire assessing executive function and self regulation. The BRIEF-SR measures 8 non-overlapping clinical scales that measure different aspects of executive functioning with the Inhibit, Shift, Emotional control and Monitor subscales combining to create a Behavioral Regulation Index (BRI) and the Working Memory, Plan/Organize, Organization of Materials and Task Completion combining to create a Meta Cognition Index. These two indices combine to create a Global Executive Composite (GEC). Only the GEC was used within this study for analysis. Raw scores were converted to T scores (using gender and age for population norms) wherein a score of 50 represents the mean and a difference of 10 from the mean indicates a difference of one standard deviation.|1 year|9 subjects missing from experimental group and 9 subjects missing from comparison group||units on a scale||Standard Deviation|Mean
640921|NCT02329015|Other Pre-specified|Self Report Questionnaire (Child and Adolescent Mindfulness Measure)|A 10 item self-report measure assessing mindfulness skills (Scale 1-4). Items are reverse scored and summed (not mean). Higher scores mean more positive mindfulness skills. Min and maximum scores are 0-40.|1 year|9 subjects missing from experimental group and 11 subjects missing from comparison group||units on a scale||Standard Deviation|Mean
640922|NCT02329015|Secondary|Warwick Edinburgh Mental Well Being Scale|A 14 item self-report measure assessing subjective well-being (1-5 scale). Higher values represent more positive mental well being. The summary measure is a sum of the 14 questions (not a mean). Summary values therefore range from 14-70.|1 year|9 subjects missing from experimental group and 11 subjects missing from comparison group||units on a scale||Standard Deviation|Mean
640923|NCT02329015|Secondary|Response to Stress Questionnaire (RSQ)|A 57-item self-report questionnaire that was used as a measure of emotional regulation We examined two of the five constructs (24 of the 57 items) within the RSQ as these were most directly theoretically relevant to expected changes due to yoga practice: voluntary engagement and involuntary engagement. Higher values represent higher levels of negative stress responses. Values for the voluntary engagement subscale represent the mean value across 9 questions on the survey and values for the involuntary subscale represent the mean value across 15 questions on the survey. Values for each item range from 0-3, trherefore the total mean values reported as outcomes range from 0-3.|1 year|Missing data: 2 from experimental group, none from control group||units on a scale||Standard Deviation|Mean
640924|NCT02329015|Primary|Academic Performance: Grade Point Averages|GPA was calculated as the numeric average of course scores of all courses taken by the student weighted by credit load of each course using a standard process within NYC public schools.|1 year|Intent to treat analysis. Data from all participants was available at baseline and at end of study.||per cent||Standard Deviation|Mean
640955|NCT02327429|Primary|Change in Total Fat Intake (3-day Food Record)|Intake assessed pre-post intervention using a 3-day food record|12 weeks|||percentage of total energy||Standard Deviation|Mean
640956|NCT02327429|Primary|Change in Protein Intake (3-day Food Record)|Intake assessed pre-post intervention using a 3-day food record|12 weeks|||percentage of total energy||Standard Deviation|Mean
640925|NCT02328937|Secondary|Limbal Redness|Limbal redness was assessed in both eyes using a slit lamp, 6-8 hours post lens insertion. Redness was assessed in 4 regions of the eye (nasal, temporal, inferior and superior) and was graded with a 5-point scale (i.e. Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). For each region (nasal, temporal, inferior and superior) the average grade was calculated by lens. The Total Grade was then calculated by summing all the average grade for each region. The regional average grade ranges from 0 to 4. The total Grade ranges from 0 to 16.|6-8 hours post lens insertion|All subjects that were dispensed at least one study lens throughout the duration of this study.||units on a scale||Standard Deviation|Mean
640926|NCT02328937|Primary|Central Corneal Swelling|Corneal swelling measurements were taken in the right eye during slit lamp evaluations, 6-8 hours post lens insertion. The average corneal swelling per lens was reported.|6-8 Hours Post lens insertion|All subjects that were dispensed at least one study lens throughout the duration of the study.||um||Standard Deviation|Mean
640927|NCT02328404|Primary|Sex Hormone Binding Globulin Concentration|"Evaluation of Biodal 50,000 IU on improvement of PCOS Prognosis by comparing the Sex Hormone Binding Globulin concentrations in both groups/arms.
One of the clinical signs of improving PCOS prognosis is the change in the Sex Hormone Binding Globulin Concentration.
In this measure , the Sex Hormone Binding Globulin Concentration in each arm were reported after completing the course of the treatment / intervention as per the study protocol. After which, the means were compared for statistical significance between the two groups / arms.
The results will be statistically analyzed using Wilcoxon (Mann-Whiteny) method at 95% confidence interval (CI) for the difference of the means within and between the two groups will be calculated."|3 months|||nmol/L||Standard Deviation|Mean
640928|NCT02328404|Primary|Free Androgen Index|"Free Androgen Index is calculated as the ratio of total testosterone to sex hormone binding globulin (SHBG).
In this measure , the Free Androgen Index in each arm were reported after completing the course of the treatment / intervention as per the study protocol. After which, the means were compared for statistical significance between the two groups / arms.
Improvement assessment of PCOS Prognosis by evaluating the change in Free Androgen Index.
One of the clinical signs of improving PCOS prognosis is the change in FAI. the results will be statistically analyzed using Wilcoxon (Mann- Whitney) method at 95% confidence interval (CI) for the difference of the means within and between the two groups will be calculated."|3 months|||Ratio||Standard Deviation|Mean
640929|NCT02328404|Primary|Total Testosterone Level|"Evaluation of the Efficacy of the dose (50,000IU) and the dose regimen as per the approved SmPC on PCOS Prognosis by measuring Change in Total Testosterone level before and after the treatment.
In this measure , the Total Testosterone levels in each arm were reported after completing the course of the treatment / intervention as per the study protocol.
One of the clinical signs of improving PCOS prognosis is the change in testosterone level. After which, the means were compared for statistical significance between the two groups / arms.
the results will be statistically analyzed using paired student t-test at 95% confidence interval (CI) for the difference of the means within and between the two groups will be calculated."|3 months|||nmol/L||Standard Deviation|Mean
640930|NCT02328404|Primary|Serum Progesterone Level|"The results below show the Serum Progesterone level after treatment in each arm after completing the course of the treatment / intervention as per the study protocol.after which, the means were compared for statistical significance between the two groups / arms. After which, the means were compared for statistical significance between the two groups / arms.
The evaluation of the Efficacy of the dose (50,000IU) and the dose regimen as per the approved SmPC on PCOS Prognosis by measuring Change in Serum Progesterone level.
One of the clinical signs of improving PCOS prognosis is the change in progesterone level. the results will be statistically analyzed using paired student t-test at 95% confidence interval (CI) for the difference of the means within and between the two groups will be calculated."|3 months|||nmol/L||Standard Error|Mean
640931|NCT02328404|Secondary|Serum C-Reactive Protien Concentration|"Evaluation of the Efficacy of the Dose (50,000IU) and the Dose Regimen on inflammation by measuring reduction of the serum concentration of C-Reactive Protein before and after the treatment.
In this measure , Serum C-Reactive Protien Concentration in each arm were reported after completing the course of the treatment / intervention as per the study protocol (Treatment with either Biodal or Placebo for 3 months). After which, the means were compared for statistical significance between the two groups / arms."|3 months|||mg/L||Standard Error|Mean
640932|NCT02328404|Primary|Hirsutism Score|"The scale ranges between 0 and 36, where A score of 8 or higher was considered as androgen excess (Ferriman and Gallwey, 1961).Evaluation of the Efficacy of the dose (50,000IU) and the dose regimen as per the approved SmPC on PCOS prognosis by evaluating Hirsutism Score.Hirsutism score was assessed using self-administrated Ferriman-Gallwey scoring system (Ferriman and Gallwey, 1961). Each participant answered the hirsutism test with the help of a trained nurse who was working in the same clinic. The score of each body site may range between 0 (no excessive terminal hair growth) to 4 (extensive terminal hair growth).
In this measure , the hirsutism score were reported in each are after completing the course of treatment/ intervention as per the study protocol. after which, the means were compared for statistical significance between the two groups / arms."|3 months|||units on a scale||Standard Error|Mean
640933|NCT02328404|Secondary|Serum Phosphorous Concentration|"Evaluation of the safety of the dose and the dose regimen as per the SmPC by measuring the change in the level of serum PO4 Concentration before and after the treatment and/or reporting as adverse event through the trial period.as the increase of Serum phosphoruse concentration above the normal level is considered as adverse event for the intervention dose regimen of this study for the purpose of evaluating the safety.
In this measure , Serum Phosphorous Concentration in each arm were reported after completing the course of the treatment / intervention as per the study protocol (Treatment with either Biodal or Placebo for 3 months). After which, the means were compared for statistical significance between the two groups / arms."|3 months|||mmol/L||Standard Error|Mean
640934|NCT02328404|Secondary|Serum Calcium Concentration|"Evaluation of the safety of the dose and the dose regimen as per the SmPC by measuring the change in the level of serum Calcium before and after the treatment and/or reporting it as adverse. event through the trial period. as the increase of Serum calcium concentration above the normal level is considered as adverse event for the intervention dose regimen of this study for the purpose of evaluating the safety.
In this measure , Serum Calcium Concentration in each arm were reported after completing the course of the treatment / intervention as per the study protocol (Treatment with either Biodal or Placebo for 3 months). After which, the means were compared for statistical significance between the two groups / arms."|3 months|||mmol/L||Standard Error|Mean
640935|NCT02328404|Primary|Menstrual Regularity|"Evaluation of the efficacy of the dosing regimen as per the approved SmPC (50,000 IU vitamin D3 once weekly for 3 months) on improvement in PCOS prognosis by assessment of menstrual regularity An improvement in PCOS prognosis by assessment of menstrual regularity is measured through improving progesterone level > 4 ng/mL.
One of the clinical signs of improving PCOS prognosis is menstrual cycle regularity.
In this measure ,the reported results consist of the number of volunteers/patients in each arm either with regular menstrual cycle or irregular menstrual cycle after completing the course of the treatment/ intervention as per the study protocol.
The results will be statistically analyzed using paired student t-test and 95% confidence interval (CI) for the difference of the means within and between the two groups will be calculated."|3 months|||participants|||Number
640936|NCT02328404|Secondary|Serum Parathyroid Hormone Concentration|"Evaluation of the Safety of the Dose and the Dose Regimen as Per the SmPC by measuring the change in the level of serum Serum Parathyroid Hormone (PTH) Concentration before and after the treatment and/or reporting any adverse events through the trial period.
In this measure , Serum Parathyroid Hormone Concentration in each arm were reported after completing the course of the treatment / intervention as per the study protocol (Treatment with either Biodal or Placebo for 3 months). After which, the means were compared for statistical significance between the two groups / arms."|3 months|||Pg/ml||Standard Error|Mean
640937|NCT02328404|Secondary|Body Mass Index|"Evaluation of the Efficacy of the dose (50,000IU) and the dose regimen as per the approved SmPC on reduction of body mass index to be <25-30 kg/m^2.
Evaluation of the Effectiveness of the dose (50,000IU) and the dose regimen as per the approved SmPC on reduction in Body Mass Index before and after the treatment. After which, the means were compared for statistical significance between the two groups / arms.
In this measure , Body Mass Index in each arm were reported after completing the course of the treatment / intervention as per the study protocol (Treatment with either Biodal or Placebo for 3 months)."|3 months|||kg/m^2||Standard Error|Mean
640938|NCT02328404|Secondary|Serum Glucose Concentration in Oral Glucose Tolerance Test 1st hr After Treatment|"Evaluation of the Efficacy of the dose (50,000IU) and the dose regimen as per the approved SmPC on reduction of insulin resistance and improving insulin sensitivity measuring Oral Glucose Tolerance Test 1st hr after the treatment and to compare with same at baseline point within the time frame.
In this measure , Serum Glucose Concentration in Oral Glucose Tolerance test in each arm were reported after completing the course of the treatment / intervention as per the study protocol (Treatment with either Biodal or Placebo for 3 months). After which, the means were compared for statistical significance between the two groups / arms.
One of the clinical signs of improving PCOS prognosis is the improvement in insulin resistance by evaluating the results of Oral Glucose Tolerance Test 1st hr . the results will be statistically analyzed using paired student t-test at 95% confidence interval (CI)."|3 months|||mmol/L||Standard Error|Mean
640939|NCT02328404|Secondary|Serum Chromium Concentration|"Evaluation of the Efficacy of the dose (50,000IU) and the dose regimen as per the approved SmPC on improving serum chromium level to be > 0.05 and < 0.5 ppm. which will be assessed by measuring serum chromium level before and after supplementation of Vitamin D3.
In this measure , Serum chromium Concentration in each arm were reported after completing the course of the treatment / intervention as per the study protocol. After which, the means were compared for statistical significance between the two groups / arms.
One of the clinical signs of improving PCOS prognosis is the improvement in serum chromium level . the results will be statistically analyzed using paired student t-test at 95% confidence interval (CI) for the difference of the means within and between the two groups will be calculated."|3 months|||ppm||Standard Error|Mean
640940|NCT02328404|Secondary|Serum 25-Hydroxy Vitamin D3 Level|"Evaluation of the Efficacy of the dose (50,000IU) and the dose regimen as per the approved SmPC on increase the level of serum 25(OH)D > 20 ng/ml by measuring of the serum 25(OH)D levels on 104 of the study period after 3 months treatment .
In this measure , Serum 25-Hydroxy Vitamin D3 leveln in each arm were reported after completing the course of the treatment / intervention as per the study protocol. After which, the means were compared for statistical significance between the two groups / arms."|3 months|||ng/ml||Standard Error|Mean
640941|NCT02328404|Primary|Ultrasound Examination of Number of Follicles and Ovarian Volume|"Evaluation of the efficacy of the dosing regimen as per the approved Summery of Product Characteristics (SmPC) (50,000 IU vitamin D3 once weekly for 3 months) on improvement in PCOS prognosis clinically using ultrasound examination.
In this measure the reported results were the finding of the ultrasound examination after the course of the treatment /intervention as per the study protocol and reporting the numbers of patients with normal ovaries, One normal ovary and the other is polycystic or both ovaries are poly-cystic.
An improvement in PCOS prognosis clinically by ultrasound examination is defined by:
decreasing the number of follicles to < 12 follicles measuring 2-9 mm in diameter
decreasing ovarian volume to < 10 cm3"|3 months|The participants in the treatment and placebo groups will be classified into two categories of prognosis (improved and not improved) and will be analyzed using Chi-square test, if Chi-square is higher than 3.84 (df=1) it will be statistically significant (p-value</= 0.05)||participants|||Number
640942|NCT02327429|Secondary|Change in Fasting High-density Lipoprotein Cholesterol|Fasting high-density lipoprotein cholesterol measured pre-post intervention from baseline to 3 months|12 weeks|||mg/dL||Standard Deviation|Mean
640943|NCT02327429|Secondary|Change in Fasting Low-density Lipoprotein Cholesterol|Low-density lipoprotein cholesterol measured pre-post intervention from baseline to 3 months|12 weeks|||mg/dL||Standard Deviation|Mean
640944|NCT02327429|Secondary|Change in Fasting Total Cholesterol|Fasting total cholesterol measured pre-post intervention from baseline to 3 months|12 weeks|||mg/dL||Standard Deviation|Mean
640945|NCT02327429|Secondary|Change in Fasting Triglyceride|Fasting triglyceride measured pre-post intervention from baseline to 3 months|12 weeks|||mg/dL||Standard Deviation|Mean
640946|NCT02327429|Secondary|Change in Waist Circumference|Waist circumference measured pre-post intervention from baseline to 3 months|12 weeks|||cm||Standard Deviation|Mean
640947|NCT02327429|Secondary|Change in Body Mass Index (BMI)|Body mass index calculated from weight measured pre-post and height measured pre-intervention from baseline to 3 months|12 weeks|||kg/m2||Standard Deviation|Mean
640948|NCT02327429|Secondary|Change in Hemoglobin A1c (A1c)|Hemoglobin A1c measured in capillary blood pre-post intervention from baseline to 3 months|12 weeks|||% of A1c in blood||Standard Deviation|Mean
640949|NCT02327429|Primary|Change in Cholesterol Intake (3-day Food Record)|Intake assessed pre-post intervention using a 3-day food record from baseline to 3 months|12 weeks|||milligrams||Standard Deviation|Mean
640961|NCT02326844|Other Pre-specified|Forkhead Box 03 (FOXO3a), p53-binding Protein 1 (53BP1) and RAD51 (i.e., Eukaryote Gene) Biomarkers|Patients will undergo a mandatory biopsy at baseline and reverse phase protein microarray (RPPA)26 testing will be performed to determine the potential predictive biomarkers of subsequent poly (adenosine diphosphate [ADP]) ribose polymerase inhibitors (PARPi ) response.|Baseline||03/2018||||
640962|NCT02326844|Secondary|Progression Free Survival (PFS) on BMN673 (Talazoparib) to PFS From First Poly (ADP-ribose) Polymerase Inhibitor (PARPPi) Exposure|The median time to progression after receiving BMN673 will be compared informally to the time of progression for the same patients after receiving an initial PARPi exposure. Progression is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more lesions is also considered progressions).|3 months|This outcome measure was not done because the study was prematurely closed by the Cancer Therapy Evaluation Program (CTEP) sponsor following the enrollment of 3 subjects. We were unable to analyze biomarker endpoints due to insufficient number of samples after premature closure of the study.|||||
640963|NCT02326844|Secondary|Duration of Response|Duration of response is the time between study enrollment and off-treatment date.|3 months|||months||Full Range|Median
640964|NCT02326844|Secondary|Number of Participants With Serious and Non-serious Adverse Events|Here is the number participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events v4.0. For a detailed list of events, see the adverse event module.|15 months|||Participants|||Count of Participants
640965|NCT02326844|Primary|Objective Response (Complete Response (CR) + Partial Response (PR))|Objective response (complete response (CR) + partial response (PR)) was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.|Every 2 cycles, an average of 64 days|||Participants|||Count of Participants
640966|NCT02326649|Primary|Mean Difference in Stroke Volume Between CMR and SMIC|Mean difference in stroke volume (SV) between CMR and SMIC measurements in ml|2 hours|||ml||95% Confidence Interval|Mean
640967|NCT02325856|Secondary|Complications During DW Adjustment|we wanted to compared whether the dialysis-related complications are different when DW (dry weight) is adjusted, no matter according to BCM (body composition monitor) results or clinical judgement, in both groups. The result is expressed as the percentage of months in which complications happened when DW adjustment presented (using total months which DW adjustments are present as denominator).|1 year|||% of months in which compli|Participants||Number
640968|NCT02325856|Primary|All-cause Hospitalization||1 year|||hospitalizations per patient-year||95% Confidence Interval|Number
640969|NCT02325713|Secondary|Number of Subjects With Clinically Significant Change From Baseline in Vital Signs, Physical Examinations, Electrocardiogram (ECG) and Laboratory Parameters|Vital signs included oral body temperature, blood pressure and pulse rate. Body weight was recorded for physical examinations. The 12-lead ECGs were recorded after the subjects have rested for at least 5 minutes in supine position. The parameters heart rate (HR), RR, PR, QRS, QT and QTcB calculated by the Bazett formula. Laboratory investigation including chemistry, hematology and urinalysis.|Baseline up to end of treatment (up to Day 32)|The safety population included all randomized subjects who received at least 1 dose of the trial medication and who had follow-up safety assessments.||subjects|||Number
640970|NCT02325713|Secondary|Palatability Assessment Based on Visual Analog Scale (VAS) Score|"Palatability was assessed in terms of Flavor, Smell, Sweetness, Overall liking of the medicine, Taste and Acceptability to swallow, each parameter assessed on a 0 to 100 millimeter (mm) visual analog scale (VAS), where 0 indicates Did not like and 100 indicates very much liked. Flavor, Smell, Sweetness and Overall liking of the medicine were evaluated immediately after taking the medication (Day 1, 0 Hour) and Taste and Acceptability to swallow were assessed 2-5 minutes post administration of medication."|Immediately and 2-5 minutes (min) after dosing on Day 1 of each treatment|The safety population included all randomized subjects who received at least 1 dose of the trial medication and who had follow-up safety assessments.||millimiter (mm)||Standard Deviation|Mean
640971|NCT02325713|Secondary|Number of Subjects With Treatment-emergent Adverse (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation|An adverse event (AE) was defined as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. The term TEAE is defined as AEs starting or worsening after the first intake of the stud drug.|Baseline up to end of treatment (up to Day 32)|The safety population included all randomized subjects who received at least 1 dose of the trial medication and who had follow-up safety assessments.||subjects|||Number
640972|NCT02325713|Secondary|Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to Infinity (AUC0-inf) Adjusted for the Actual Administered Dose (AUC0-inf, Adj) of D-PZQ and Racemate PZQ|AUC0-inf is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time. AUC0-inf, adj was defined as the AUC0-inf adjusted for the actual administered dose of D-PZQ and Racemate PZQ.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment|The PK population included all subjects who completed the study and for whom primary PK parameters could be calculated for the first two treatment periods.||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
640984|NCT02325518|Secondary|Least Squares Mean Change From Baseline in IOP at 9 AM|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). Data from 4 and 8 weeks at 9 AM were pooled, and a negative change indicates an improvement. One eye (target eye) was used for the analysis.|Baseline (Day 0), Week 4, Week 8 at 9 AM|Per Protocol Set (PPS)||mmHg||95% Confidence Interval|Least Squares Mean
641029|NCT02322892|Secondary|Mortality||Until hospital discharge, limit 60 days|||participants|||Number
640973|NCT02325713|Secondary|Apparent Volume of Distribution During the Terminal Phase (Vz/f) of L-PZQ, D-PZQ, and Racemate PZQ|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vz/f after oral dose was influenced by the fraction absorbed.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment|"The PK population included all subjects who completed the study and for whom primary PK parameters could be calculated for the first two treatment periods. Here, n signifies those subjects who were evaluable for specified isomers (L-PZQ and D-PZQ) or the racemate mixture of PZQ for each arm, respectively."||Liters||Geometric Coefficient of Variation|Geometric Mean
640974|NCT02325713|Secondary|Apparent Total Body Clearance of Drug From Plasma (CL/f) of L-PZQ, D-PZQ, and Racemate PZQ|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment|The PK population included all subjects who completed the study and for whom primary PK parameters could be calculated for the first two treatment periods. Here, “n” signifies those subjects who were evaluable for specified isomers (L-PZQ and D-PZQ) or the racemate mixture of PZQ for each arm, respectively.||Liter/hour||Geometric Coefficient of Variation|Geometric Mean
640975|NCT02325713|Secondary|Relative Bioavailability (Frel) of L-PZQ, D-PZQ, and Racemate PZQ|Frel was calculated for Treatment A versus Treatment B only. It was calculated by using AUC0-∞, with treatment A as the Test and treatment B as the Reference. Frel = AUC0-inf (test) / AUC0-inf (reference).|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment|The PK population included all subjects who completed the study and for whom primary PK parameters could be calculated for the first two treatment periods.||percent bioavailability||Geometric Coefficient of Variation|Geometric Mean
640976|NCT02325713|Secondary|Apparent Terminal Elimination Rate Constant (λz) of L-PZQ, D-PZQ, and Racemate PZQ|λz was determined from the terminal slope of the log-transformed plasma concentration curve using linear regression method.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment|The PK population included all subjects who completed the study and for whom primary PK parameters could be calculated for the first two treatment periods. Here, “n” signifies those subjects who were evaluable for specified isomers (L-PZQ and D-PZQ) or the racemate mixture of PZQ for each arm, respectively.||1/h||Geometric Coefficient of Variation|Geometric Mean
640977|NCT02325713|Secondary|Extrapolated Area Under the Plasma Concentration Curve From Time Tlast to Infinity (AUCextra) of L-PZQ, D-PZQ, and Racemate PZQ|AUCextra was reported in terms of percentage of AUC0-inf.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment|The PK population included all subjects who completed the study and for whom primary PK parameters could be calculated for the first two treatment periods. Here, “n” signifies those subjects who were evaluable for specified isomers (L-PZQ and D-PZQ) or the racemate mixture of PZQ for each arm, respectively.||percentage of AUC0-inf||Geometric Coefficient of Variation|Geometric Mean
640978|NCT02325713|Secondary|AUC From Time Zero to the Last Sampling Time at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) Adjusted for the Actual Administered Dose (AUC0-t, Adj) of L-PZQ, D-PZQ, and Racemate PZQ||Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment|The PK population included all subjects who completed the study and for whom primary PK parameters could be calculated for the first two treatment periods.||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
640979|NCT02325713|Secondary|Time Prior to the First Measurable (Non-zero) Concentration (Tlag) of L-PZQ, D-PZQ, and Racemate PZQ||Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment|The PK population included all subjects who completed the study and for whom primary PK parameters could be calculated for the first two treatment periods.||hours||Full Range|Median
640980|NCT02325713|Secondary|Apparent Terminal Half-life (t1/2) of L-PZQ, D-PZQ, and Racemate PZQ|Apparent terminal half-life was defined as the time required for the plasma concentration of drug to decrease 50 percent in the final stage of its elimination.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment|The PK population included all subjects who completed the study and for whom primary PK parameters could be calculated for the first two treatment periods. Here, “n” signifies those subjects who were evaluable for specified isomers (L-PZQ and D-PZQ) or the racemate mixture of PZQ for each arm, respectively.||hours||Geometric Coefficient of Variation|Geometric Mean
640981|NCT02325713|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of L-PZQ, D-PZQ, and Racemate PZQ||Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment|The PK population included all subjects who completed the study and for whom primary PK parameters could be calculated for the first two treatment periods.||hours||Full Range|Median
640982|NCT02325713|Secondary|Maximum Observed Concentration in Plasma (Cmax) Adjusted for the Actual Administered Dose (Cmax, Adj) of L-PZQ, D-PZQ and Racemate PZQ||Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment|The PK population included all subjects who completed the study and for whom primary PK parameters could be calculated for the first two treatment periods.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
640983|NCT02325713|Primary|Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUC0-inf) Adjusted for the Actual Administered Dose (AUC0-inf, Adj) of L-Praziquantel (L-PZQ)|AUC0-inf is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time. AUC0-inf, adj was defined as the AUC0-inf adjusted for the actual administered dose of L-PZQ.|Pre-dose,0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment|The pharmacokinetic (PK) population included all subjects who completed the study and for whom primary PK parameters could be calculated for the first two treatment periods. Here, ‘N’ (number of participants analyzed) signifies those subjects who were evaluable for this outcome measure.||Hour*nanograms per milliliter (h*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
641021|NCT02324660|Secondary|Cardiac Adverse Events|cumulative occurrence of death, myocardial infarction and heart failure|1 year after inclusion|||partecipants|||Number
640985|NCT02325518|Primary|Least Squares Mean Change From Baseline in Intraocular Pressure (IOP) at 11 AM|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). Data from 4 and 8 weeks at 11 AM were pooled, and a negative change indicates an improvement. One eye (target eye) was used for the analysis.|Baseline (Day 0), Week 4, Week 8 at 11 AM|This analysis population includes all subjects who received study medication and met inclusion/exclusion criteria prior to randomization (Per Protocol Set).||mmHg||95% Confidence Interval|Least Squares Mean
640986|NCT02324673|Primary|Number of Participants With Suicide Related Thoughts and Behaviors Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)|The C-SSRS captured the occurrence, severity, and frequency of suicide related thoughts and behaviors at Day 11. The C-SSRS was only used for participants ≥ 7 years of age. The number of participants with results of “Yes” for Suicidal Ideation (Wish to be Dead and Non-Specific Active Suicidal Thoughts) and Suicidal Behavior (Actual Attempt, Interrupted Attempt, Aborted Attempt, Preparatory Acts or Behavior, and Suicidal Behavior) are reported.|Day 11|Participants from the Safety Analysis Population (SAF), all participants who received ≥1 dose of the investigational product, who completed the C-SSRS.||Participants|||Count of Participants
640987|NCT02324673|Primary|Change From Baseline in Daily Seizure Activity|The specific number of tonic and atonic seizures per study day were recorded in a diary. The change in number of seizures at Day 11 relative to Baseline is reported. A negative change from Baseline indicates an improvement based on Daily Seizure Activity.|Baseline and Day 11|EFF, all participants who received ≥1 dose of the investigational product and had ≥1 efficacy assessment for number of seizures per day at Day 11.||number of seizures per day||Standard Deviation|Mean
640988|NCT02324673|Primary|Change From Baseline in Clinical Global Impression of Severity (CGI-S) Assessment|The CGI-S was completed by the parents/caregivers and the Investigator and was used to rate participant’s mental illness status at Baseline (Screening) and Day 11 using a 7-point scale, where 1=normal, not mentally ill, and 7=among the most extremely mentally ill participants. This rating is based upon observed and reported symptoms, behavior, and function in the past seven days. The change in CGI-S score at Day 11 relative to Baseline is reported. A negative change from Baseline indicates improvement (decreased severity in illness).|Baseline and Day 11|EFF, all participants who received ≥1 dose of the investigational product and had ≥1 efficacy assessment for CGI-S post-dose.||scores on a scale||Standard Deviation|Mean
640989|NCT02324673|Primary|Clinical Global Impression of Improvement (CGI-I) Assessment|The CGI-I was completed by the parents/caregivers and the investigator and was used to assess participants global status of their condition on Day 11 using a 7-point scale, where 1=very much improved and 7=very much worse since the initiation of treatment.|Day 11|Efficacy Analysis Population (EFF), all participants who received ≥1 dose of the investigational product and had ≥1 efficacy assessment for CGI-I post-dose.||scores on a scale||Standard Deviation|Mean
640990|NCT02324673|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product. It does not necessarily have a causal relationship with this treatment. A TEAE was defined as any event not present prior to the initiation of the treatment or any event already present that worsens. Any laboratory (clinical chemistry, hematology, urinalysis), 12-lead electrocardiograms, vital signs (temperature, blood pressure, pulse rate, respiratory rate) and physical examination findings deemed by the investigator to be clinically significant were captured as AEs. A SAE is any untoward medical occurrence that results in death, is life-threatening, requires the participant be at a risk of death at the time of the event, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality/birth defect, or other serious event that requires medical or surgical intervention.|From the first dose of study drug up to Day 17|Safety Analysis Population (SAF), all participants who received ≥1 dose of the investigational product.||Participants|||Count of Participants
640991|NCT02324673|Primary|Time Linearity Index for Cannabidiol and Metabolite 7-OH Cannabidiol in Participants ≥2 Years of Age|"Time linearity index is calculated as the ratio of AUC(0-12) on Day 10/AUC[0-inf] on Day 1.
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:
Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to <2 years were not included in this analysis."|Day 1 and Day 10|PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for time linearity index.||ratio||Standard Deviation|Mean
640992|NCT02324673|Primary|Accumulation Ratio for AUC(0-12) [RAUC(0-12)] on Day 10 for Cannabidiol and Metabolite 7-OH Cannabidiol|"RAUC(0-12) is the ratio of AUC(0-12) at Day 10 compared to AUC(0-12) at Day 1.
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:
Participants ages 1 to <2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to <6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose."|Day 10 at age-specific times|PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for RAUC(0-12).||ratio||Standard Deviation|Mean
640993|NCT02324673|Primary|Accumulation Ratio for Cmax (RCmax) on Day 10 for Cannabidiol and Metabolite 7-OH Cannabidiol|"RCmax is the ratio of Cmax at Day 10 compared to Cmax at Day 1.
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:
Participants ages 1 to <2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to <6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose."|Day 10 at age-specific times|PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for RCmax.||ratio||Standard Deviation|Mean
640994|NCT02324673|Primary|Average Plasma Concentration (Cavg) for Cannabidiol and Metabolite 7-OH Cannabidiol|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:
Participants ages 1 to <2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to <6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose."|Day 10 at age-specific times|PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for Cavg.||ng/mL||Standard Deviation|Mean
640995|NCT02324673|Primary|Minimum Plasma Concentration (Cmin) for Cannabidiol and Metabolite 7-OH Cannabidiol|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:
Participants ages 1 to <2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to <6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose."|Day 10 at age-specific times|PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for Cmin.||ng/mL||Standard Deviation|Mean
640996|NCT02324673|Primary|Dose Normalized AUC(0-12) [AUC (0-12)/D] for Cannabidiol and Metabolite 7-OH Cannabidiol on Day 10|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:
Participants ages 1 to <2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to <6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose."|Day 10 at age-specific times|PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for AUC(0-12)/D.||ng*h/mL/(mg/kg)||Standard Deviation|Mean
640997|NCT02324673|Primary|AUC(0-12) for Cannabidiol and Metabolite 7-OH Cannabidiol on Day 10|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:
Participants ages 1 to <2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to <6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose."|Day 10 at age-specific times|PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for AUC(0-12).||ng*h/mL||Standard Deviation|Mean
640998|NCT02324673|Primary|Metabolite to Parent Ratio for AUC(0-12) [MRAUC(0-12)] on Day 10|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:
Participants ages 1 to <2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to <6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose.
MRAUC(0-12) was adjusted for molecular weight differences between cannabidiol (341.46) and 7-OH cannabidiol (330.46)."|Day 10 at age-specific times|Participants ≥2 years from the PK Population who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for MRAUC(0-12).||ratio||Standard Deviation|Mean
640999|NCT02324673|Primary|Metabolite to Parent Ratio for AUC(0-12) [MRAUC(0-12)] on Day 1|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:
Participants ages 1 to <2 years: Day 1 at 2, 4, 8, 12 hours post-dose; Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose.
MRAUC(0-12) was adjusted for molecular weight differences between cannabidiol (341.46) and 7-OH cannabidiol (330.46)."|Day 1 at age-specific times|Participants ≥2 years from the PK Population who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for MRAUC(0-12).||ratio||Standard Deviation|Mean
641000|NCT02324673|Primary|Metabolite to Parent Ratio for AUC(0-inf) [MRAUC(0-inf)] on Day 1 for Participants ≥2 Years of Age|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:
Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to <2 years were not included in this analysis.
MRAUC(0-inf) was adjusted for molecular weight differences between cannabidiol (341.46) and 7-OH cannabidiol (330.46)."|Day 1 at age-specific times|Participants ≥2 years from the PK Population who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for MRAUC(0-inf).||ratio||Standard Deviation|Mean
641001|NCT02324673|Primary|MRCmax on Day 10|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:
Participants ages 1 to <2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to <6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose.
MRCmax was adjusted for molecular weight differences between cannabidiol (341.46) and 7-OH cannabidiol (330.46)."|Day 10 at age-specific times|PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for metabolite to parent ratio.||ratio||Standard Deviation|Mean
641002|NCT02324673|Primary|Metabolite (7-OH Cannabidiol) to Parent (Cannabidiol) Ratio for Cmax [MRCmax] on Day 1|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:
Participants ages 1 to <2 years: Day 1 at 2, 4, 8, 12 hours post-dose; Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose.
MRCmax was adjusted for molecular weight differences between cannabidiol (341.46) and 7-OH cannabidiol (330.46)."|Day 1 at age-specific times|PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for MRCmax.||ratio||Standard Deviation|Mean
641003|NCT02324673|Primary|Dose Normalized AUC(0-inf) [AUC(0-inf)/D] for Cannabidiol and Metabolite 7-OH Cannabidiol on Day 1 for Participants ≥2 Years of Age|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:
Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to <2 years were not included in this analysis."|Day 1 at age-specific times|Participants ≥2 years from the PK Population who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for AUC(0-inf)/D.||ng*h/mL/(mg/kg)||Standard Deviation|Mean
641004|NCT02324673|Primary|AUC From Time 0 to Infinity [AUC(0-inf)] for Cannabidiol and Metabolite 7-OH Cannabidiol on Day 1 for Participants ≥2 Years of Age|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:
Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to <2 years were not included in this analysis."|Day 1 at age-specific times|Participants ≥2 years from the PK Population who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for AUC(0-inf).||ng*h/mL||Standard Deviation|Mean
641005|NCT02324673|Primary|AUC From Time 0 to the Last Quantifiable Concentration [AUC(0-last)] on Day 1 for Cannabidiol and Metabolite 7-OH Cannabidiol on Day 1 for Participants ≥2 Years of Age|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:
Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to <2 years were not included in this analysis."|Day 1 at age-specific times|Participants ≥2 years from the PK Population who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for AUC(0-last).||ng*h/mL||Standard Deviation|Mean
641006|NCT02324673|Primary|Dose Normalized AUC(0-12) [AUC (0-12)/D] for Cannabidiol and Metabolite 7-OH Cannabidiol on Day 1|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:
Participants ages 1 to <2 years: Day 1 at 2, 4, 8, 12 hours post-dose; Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose."|Day 1 at age-specific times|PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for AUC(0-12)/D.||ng*h/mL||Standard Deviation|Mean
641007|NCT02324673|Primary|Area Under the Plasma-Concentration Time Curve From 0 to 12 Hours Post-dose [AUC(0-12)] for Cannabidiol and Metabolite 7-OH Cannabidiol on Day 1|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:
Participants ages 1 to <2 years: Day 1 at 2, 4, 8, 12 hours post-dose; Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose."|Day 1 at age-specific times|PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for AUC(0-12).||ng*h/mL||Standard Deviation|Mean
641008|NCT02324673|Primary|Volume of Distribution (Vz/F) of Cannabidiol for Participants ≥2 Years of Age|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:
Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to <2 years were not included in this analysis."|Day 1 at age-specific times|Participants ≥2 years from the PK Population who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for Vz/F.||L/kg||Standard Deviation|Mean
641009|NCT02324673|Primary|Oral Clearance (CL/F) for Cannabidiol for Participants ≥2 Years of Age|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:
Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to <2 years were not included in this analysis."|Day 1 at age-specific times|Participants ≥2 years from the PK Population who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for CL/F.||Liters (L)/h/kg||Standard Deviation|Mean
641010|NCT02324673|Primary|Elimination Rate (Lambda-z [λz]) for Cannabidiol and Metabolite 7-OH Cannabidiol for Participants ≥2 Years of Age|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:
Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to <2 years were not included in this analysis."|Day 1 at age-specific times|Participants ≥2 years from the PK Population who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for λz.||1/h||Standard Deviation|Mean
641011|NCT02324673|Primary|Half Life (t1/2) for Cannabidiol and Metabolite 7-OH Cannabidiol for Participants ≥2 Years of Age|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:
Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to <2 years were not included in this analysis."|Day 1 at age-specific times|Participants ≥2 years from the PK Population who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for t1/2.||h||Standard Deviation|Mean
641012|NCT02324673|Primary|Time to Cmax (Tmax) for Cannabidiol and Metabolite 7-OH Cannabidiol|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:
Participants ages 1 to <2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to <6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose."|Day 10 at age-specific times|PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for tmax.||h||Full Range|Median
641013|NCT02324673|Primary|Time to Cmax (Tmax) for Cannabidiol and Metabolite 7-OH Cannabidiol|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:
Participants ages 1 to <2 years: Day 1 at 2, 4, 8, 12 hours post-dose; Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose."|Day 1 at age-specific times|PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for tmax.||hours (h)||Full Range|Median
641014|NCT02324673|Primary|Cmax/D for Cannabidiol and Metabolite 7-OH Cannabidiol|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:
Participants ages 1 to <2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to <6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose."|Day 10 at age-specific times|PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for Cmax.||ng/mL/(mg/kg)||Standard Deviation|Mean
641015|NCT02324673|Primary|Dose Normalized Cmax (Cmax/D) for Cannabidiol and Metabolite 7-OH Cannabidiol|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:
Participants ages 1 to <2: Day 1 at 2, 4, 8, 12 hours post-dose; Participants ages 2 to <6: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17: Day 1 pre-dose and at 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 hours post-dose."|Day 1 at age-specific times|PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for Cmax.||ng/mL/(mg/kg)||Standard Deviation|Mean
641016|NCT02324673|Primary|Cmax for Cannabidiol and Metabolite 7-OH Cannabidiol|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:
Participants ages 1 to <2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to <6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose."|Day 10 at age-specific times|PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for Cmax.||ng/mL||Standard Deviation|Mean
641017|NCT02324673|Primary|Maximum Plasma Concentration (Cmax) for Cannabidiol and Metabolite 7-hydroxy (7-OH) Cannabidiol|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:
Participants ages 1 to <2 years: Day 1 at 2, 4, 8, 12 hours post-dose; Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 hours post-dose."|Day 1 at age-specific times|Pharmacokinetic population (PK), all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for Cmax.||nanograms/milliliter (ng/mL)||Standard Deviation|Mean
641018|NCT02324660|Other Pre-specified|Cardiac Death|occurrence of cardiac death|1 year||||||
641019|NCT02324660|Other Pre-specified|Adverse Events|hospital admission for ACS, for bleeding complications, for respiratory failure, for arrhytmias, for pneumonia|1 year after inclusion||||||
641020|NCT02324660|Secondary|Undiagnosed COPD|percentage of patients admitted to hospital for ACS and with undiagnosed COPD|2 months||||||
641032|NCT02322892|Secondary|Percentage Change From Baseline in Pyruvate Dehydrogenase (PDH) Enzyme Activity|PDH activity will be measured in isolated peripheral blood mononuclear cells using a novel immunocapture and microplate-based method. Reported as relative change from before the surgery.|Post-surgery within 1 hour of arrival to the ICU|||Percent change from baseline||Inter-Quartile Range|Median
641033|NCT02322892|Primary|Lactate Levels||Post-surgery within 1 hour of arrival to the ICU|Modified intention to treat||mmol/L||Inter-Quartile Range|Median
641034|NCT02322879|Primary|Rise in Plasma Transaminases: Proportion of Responders.|Blood tests to monitor Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) were obtained on every visit prior dosing. ALT and AST were analyzed on a Roche Cobas c501 chemistry module at BIDMC. Responders was defined as peak ALT increased 2x baseline (average of first 3 days)|Daily during the treatment periods (D1-D14 and D29 to 42)|||Participants|||Count of Participants
641035|NCT02322788|Primary|Provocative Concentration of Methacholine Which Produces a 20% Fall in FEV1 (PC20)||4 cross-over treatments (<1 day each) with 2-10 days between treatment washout periods|Efficacy analysis set||mg/mL||95% Confidence Interval|Least Squares Mean
641036|NCT02322775|Secondary|Peripheral Blood Eosinophil Levels|"Peripheral blood eosinophil levels assessments were collected from all patients at baseline prior to first benralizumab administration at Day 1, at the Week 12 visit or the IP discontinuation visit, and at the Week 20 follow-up visit.
Changes at Week 12 (respectively at Week 20) were calculated based on patients with both baseline and Week 12 (respectively Week 20)."|Baseline, Week 12 and Week 20|The safety analysis set comprised all patients who received at least one dose of IP. Patients were classified according to the treatment they actually received. A patient who has on one or several occasions received active treatment was classified as active.||Cells/µL||Full Range|Median
641037|NCT02322775|Secondary|Serum Concentrations (ng/mL)|Blood samples (processed to serum) for pharmacokinetic assessments were collected from all patients at baseline prior to first benralizumab administration at Day 1, at the Week 12 visit or the IP discontinuation visit, and at the Week 20 follow-up visit. Serum concentrations of benralizumab were determined using a validated electrochemiluminescent (ECL) immunoassay.|Baseline, Week 12 and Week 20|The pharmacokinetic (PK) analysis set comprised all patients who received benralizumab and from whom PK blood samples were obtained are assumed not to be affected by factors such as protocol violations. Those patients who had at least 1 quantifiable serum PK observation post first dose were included in the PK analysis dataset.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
641038|NCT02322775|Secondary|Change From Baseline in AQLQ(S)+12 Total and Domain Scores at Week 12|"The asthma quality of life questionnaire for 12 years and older, AQLQ(S)+12, consists of 32 questions; all assessed on a 7-point scale from 7 to 1, where 7 represents no impairment and 1 represents severe impairment. The 4 individual domain scores (symptoms, activity limitations, emotional function, and environmental stimuli) are the means of the responses to the questions in each of the domains. The overall score is calculated as the mean response to all questions. The changes from baseline of AQLQ(S)+12 score are compared between benralizumab 30 mg Q4W and placebo by using the analyse of covariance (ANCOVA) with baseline blood eosinophil count (≥300 cells/μL or <300 cells/μL) and region (Europe or North America) as fixed effects and baseline AQLQ(S)+12 score as a covariate.
Changes at Week 12 were calculated based on patients with both baseline and Week 12."|Baseline and Week 12|The Full Analysis Set comprised all patients randomised and receiving any investigational product (IP), irrespective of their protocol adherence and continued participation in the study.||Scores on a scale||Standard Deviation|Mean
641039|NCT02322775|Secondary|Asthma Exacerbations|An asthma exacerbation was defined as a worsening of asthma that led to use of systemic corticosteroids for at least 3 days (a single depo-injectable dose of corticosteroids was considered equivalent to a 3-day course of systemic corticosteroids) or an emergency room or urgent care visit (defined as evaluation and treatment for <24 hours in an emergency department or urgent care center) due to asthma that required systemic corticosteroids (as per above) or an inpatient hospitalization (defined as admission to an inpatient facility and/or evaluation and treatment in a healthcare facility for ≥24 hours) due to asthma. Number of patients experiencing an event included in the definition of asthma exacerbation was presented.|Up to Week 12|The Full Analysis Set comprised all patients randomised and receiving any investigational product (IP), irrespective of their protocol adherence and continued participation in the study.||Patients per number of exacerbations|||Number
641040|NCT02322775|Secondary|Change From Baseline in Mean ACQ-6 Score at Week 12|"The asthma control questionnaire, ACQ-6, consists of six questions; all assessed on a 7-point scale from 0 to 6, where 0 represents good control and 6 represents poor control. The overall score is the mean of the responses to each of the six questions. The changes from baseline of ACQ-6 score are compared between benralizumab 30 mg Q4W and placebo by using the mixed-effect repeated measures (MMRM) with baseline blood eosinophil count (≥300 cells/μL or <300 cells/μL), protocol specified visit (Week 4, Week 8, Week 12), region (Europe or North America) and treatment*visit interaction as fixed effects and baseline ACQ-6 score as a covariate.
Changes at Week 12 were calculated based on patients with both baseline and Week 12."|Baseline, Week 4, Week 8 and Week 12|The Full Analysis Set comprised all patients randomised and receiving any investigational product (IP), irrespective of their protocol adherence and continued participation in the study.||Scores on a scale||Standard Deviation|Mean
641041|NCT02322775|Secondary|Change From Baseline in Proportion of Nights With Nocturnal Awakenings at Week 12|"Nocturnal awakenings due to asthma symptoms and requiring rescue medication use was recorded by the patient in the asthma daily diary each morning. Proportion of nights with nocturnal awakenings was defined as the number of nights with awakenings due to asthma and requiring rescue medication divided by number of nights with data for awakening due to asthma. The outcome variable for proportion of nights with nocturnal awakenings was the change from baseline at Week 12 in weekly proportion of nights with nocturnal awakenings. The changes are compared between benralizumab 30 mg Q4W and placebo by using the mixed-effect model repeated measures (MMRM) with baseline blood eosinophil count (≥300 cells/μL or <300 cells/μL), protocol specified visit, region (Europe or North America) and treatment*visit interaction as fixed effects and baseline proportion of nights with nocturnal awakenings as a covariate.
Changes at Week 12 were calculated based on patients with both baseline and Week 12."|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12|The Full Analysis Set comprised all patients randomised and receiving any investigational product (IP), irrespective of their protocol adherence and continued participation in the study.||Proportion of nights||Standard Deviation|Mean
641042|NCT02322775|Secondary|Change From Baseline in Total Asthma Rescue Medication Use (Puffs) at Week 12|"The number of rescue medication inhalations and nebulizer treatments taken were recorded by the patient in the asthma daily diary twice daily. The number of inhalations (puffs) per day was calculated as [number of night inhaler puffs] + 2 x [number of night nebulizer times] + number of day inhaler puffs + 2 x [number of day nebulizer times]. The changes from baseline in weekly total asthma rescue medication use (puffs) are compared between benralizumab 30 mg Q4W and placebo by using the mixed-effect model repeated measures (MMRM) with baseline blood eosinophil count (≥300 cells/μL or <300 cells/μL), protocol specified visit, region (Europe or North America) and treatment*visit interaction as fixed effects and baseline total asthma rescue medication use (puffs) as a covariate.
Changes at Week 12 were calculated based on patients with both baseline and Week 12."|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12|The Full Analysis Set comprised all patients randomised and receiving any investigational product (IP), irrespective of their protocol adherence and continued participation in the study.||Puffs per day||Standard Deviation|Mean
641043|NCT02322775|Secondary|Change From Baseline in Total Asthma Symptom Score at Week 12|"Asthma symptoms were recorded by the patient each morning and evening in the asthma daily diary. Symptoms were recorded using a scale of 0-3, where 0 indicates no asthma symptoms. The daily asthma symptom total score was calculated by taking the sum of the daytime score recorded in the evening and the nighttime score recorded the following morning. The weekly total asthma score was averaged from the daily scores over a 7 day period, with score ranging from 0 to 6, where 0 indicates no asthma symptoms. The changes from baseline of weekly total asthma score are compared between benralizumab 30 mg Q4W and placebo by using the mixed-effect model repeated measures (MMRM) with baseline blood eosinophil count (≥300 cells/μL or <300 cells/μL), protocol specified visit, region (Europe or North America) and treatment*visit interaction as fixed effects and baseline total asthma score as a covariate.
Changes at Week 12 were calculated based on patients with both baseline and Week 12."|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12|The Full Analysis Set comprised all patients randomised and receiving any investigational product (IP), irrespective of their protocol adherence and continued participation in the study.||Scores on a scale||Standard Deviation|Mean
641044|NCT02322775|Secondary|Change From Baseline in Evening Peak Expiratory Flow (PEF) (L/Min) at Home at Week 12|"The changes from baseline of weekly average of evening PEF (L/min) are compared between benralizumab 30 mg Q4W and placebo by using the mixed-effect model for repeated measures (MMRM) with baseline blood eosinophil count (≥300 cells/μL or <300 cells/μL), protocol specified visit, region (Europe or North America) and treatment*visit interaction as fixed effects and baseline evening PEF (L/min) as a covariate.
Changes at Week 12 were calculated based on patients with both baseline and Week 12."|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12|The Full Analysis Set comprised all patients randomised and receiving any investigational product (IP), irrespective of their protocol adherence and continued participation in the study.||L/min||Standard Deviation|Mean
641045|NCT02322775|Secondary|Change From Baseline in Morning Peak Expiratory Flow (PEF) (L/Min) at Home at Week 12|"The changes from baseline of weekly average of morning PEF (L/min) are compared between benralizumab 30 mg Q4W and placebo by using the mixed-effect model for repeated measures (MMRM) with baseline blood eosinophil count (≥300 cells/μL or <300 cells/μL), protocol specified visit, region (Europe or North America) and treatment*visit interaction as fixed effects and baseline morning PEF (L/min) as a covariate.
Changes at Week 12 were calculated based on patients with both baseline and Week 12."|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12|The Full Analysis Set comprised all patients randomised and receiving any investigational product (IP), irrespective of their protocol adherence and continued participation in the study.||L/min||Standard Deviation|Mean
641046|NCT02322775|Primary|Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) (L) at Week 12|"The FEV1 (L) change from baseline are compared between benralizumab 30 mg Q4W and placebo by using the mixed-effect repeated measures (MMRM) analysis with baseline blood eosinophil count (≥300 cells/μL or <300 cells/μL), protocol specified visit (Week 4, Week 8, Week 12), region (Europe or North America) and treatment*visit interaction as fixed effects and baseline pre-bronchodilator FEV1 (L) as a covariate.
Changes at Week 12 were calculated based on patients with both baseline and Week 12."|Baseline, Week 4, Week 8 and Week 12|The Full Analysis Set comprised all patients randomised and receiving any investigational product (IP), irrespective of their protocol adherence and continued participation in the study.||Litre||Standard Deviation|Mean
641047|NCT02322749|Secondary|The PK of N-desmethyl Selumetinib by Assessment of the AUC(0-t)|The PK of the metabolite N-desmethyl selumetinib was evaluated by assessing the AUC(0-t) of the metabolite in healthy volunteers after oral administration of single doses of the blue reference capsule (Treatment A), the free base variant capsule (Treatment B) and the TPGS variant capsule (Treatment C).|Blood samples were collected pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose for each of the separate treatment periods (Visits 2, 3 and 4).|The PK analysis set included all healthy subjects who received at least 1 dose of selumetinib and had at least 1 post-dose PK measurement without important protocol deviations/violations or events significantly affecting the PK.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
641048|NCT02322749|Secondary|The PK of the Metabolite N-desmethyl Selumetinib by Assessment of Cmax|The PK of the metabolite N-desmethyl selumetinib was evaluated by assessing the Cmax of the metabolite in healthy volunteers after oral administration of single doses of the blue reference capsule (Treatment A), the free base variant capsule (Treatment B) and the TPGS variant capsule (Treatment C).|Blood samples were collected pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose for each of the separate treatment periods (Visits 2, 3 and 4).|The PK analysis set included all healthy subjects who received at least 1 dose of selumetinib and had at least 1 post-dose PK measurement without important protocol deviations/violations or events significantly affecting the PK.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
641070|NCT02320838|Secondary|Nerve Conduction Latency Post-treatment 20 Min.|The compound action potential latencies will be measured and will be expressed in ms.|at 20 min. post-treatment|||ms||Standard Deviation|Mean
641071|NCT02320838|Secondary|Baseline Nerve Conduction Latency|The compound action potential latencies will be measured and will be expressed in ms.|Baseline at 0 min.|||ms||Standard Deviation|Mean
641049|NCT02322749|Secondary|Relative Bioavailability of the TPGS Capsule Variant (Treatment C) Compared to the Blue Reference Capsule (Treatment A) [Selumetinib AUC(0-t)]|The relative bioavailability of the TPGS capsule variant of selumetinib (Treatment C) as compared to the blue reference capsule (Treatment A) was evaluated by comparing the AUC[0-t] of selumetinib in healthy volunteers.|Blood samples were collected pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose for each of the separate treatment periods (Visits 2, 3 and 4).|The PK analysis set included all healthy subjects who received at least 1 dose of selumetinib and had at least 1 post-dose PK measurement without important protocol deviations/violations or events significantly affecting the PK.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
641050|NCT02322749|Secondary|Relative Bioavailability of the TPGS Capsule Variant (Treatment C) Compared to the Blue Reference Capsule (Treatment A) [Selumetinib AUC]|The relative bioavailability of the TPGS capsules variant of selumetinib (Treatment C) as compared to the blue reference capsule (Treatment A) was evaluated by comparing the AUC of selumetinib in healthy volunteers.|Blood samples were collected pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose for each of the separate treatment periods (Visits 2, 3 and 4).|The PK analysis set included all healthy subjects who received at least 1 dose of selumetinib and had at least 1 post-dose PK measurement without important protocol deviations/violations or events significantly affecting the PK.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
641051|NCT02322749|Secondary|Relative Bioavailability of the TPGS Capsule Variant (Treatment C) Compared to the Blue Reference Capsule (Treatment A) [Selumetinib Cmax]|The relative bioavailability of the TPGS capsule variant of selumetinib (Treatment C) as compared to the blue reference capsule (Treatment A) was evaluated by comparing the Cmax of selumetinib in healthy volunteers.|Blood samples were collected pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose for each of the separate treatment periods (Visits 2, 3 and 4).|The PK analysis set included all healthy subjects who received at least 1 dose of selumetinib and had at least 1 post-dose PK measurement without important protocol deviations/violations or events significantly affecting the PK.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
641052|NCT02322749|Primary|Bioequivalence of the Free Base Variant of Selumetinib (Treatment B) Compared to the Blue Reference Capsule (Treatment A) [Selumetinib AUC(0-t)]|The bioequivalence of the free base variant of selumetinib (Treatment B) as compared to the blue reference capsule (Treatment A) was evaluated by comparing the AUC from time zero to the time of the last quantifiable concentration (AUC[0-t]) of selumetinib in healthy volunteers.|Blood samples were collected pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post dose for each of the separate treatment periods (Visits 2, 3 and 4).|The PK analysis set included all healthy subjects who received at least 1 dose of selumetinib and had at least 1 post-dose PK measurement without important protocol deviations/violations or events significantly affecting the PK.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
641053|NCT02322749|Primary|Bioequivalence of the Free Base Variant of Selumetinib (Treatment B) Compared to the Blue Reference Capsule (Treatment A) [Selumetinib AUC]|The bioequivalence of the free base variant of selumetinib (Treatment B) as compared to the blue reference capsule (Treatment A) was evaluated by comparing the area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC) of selumetinib in healthy volunteers.|Blood samples were collected pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post dose for each of the separate treatment periods (Visits 2, 3 and 4).|The PK analysis set included all healthy subjects who received at least 1 dose of selumetinib and had at least 1 post-dose PK measurement without important protocol deviations/violations or events significantly affecting the PK.||ng * hour per mL (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
641054|NCT02322749|Primary|Bioequivalence of the Free Base Variant of Selumetinib (Treatment B) Compared to the Blue Reference Capsule (Treatment A) [Selumetinib Cmax]|The bioequivalence of the free base variant of selumetinib (Treatment B) as compared to the blue reference capsule (Treatment A) was evaluated by comparing the maximum observed plasma concentration (Cmax) of selumetinib in healthy volunteers.|Blood samples were collected pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post dose for each of the separate treatment periods (Visits 2, 3 and 4).|The Pharmacokinetic (PK) analysis set included all healthy subjects who received at least 1 dose of selumetinib and had at least 1 post-dose PK measurement without important protocol deviations/violations or events significantly affecting the PK.||nanograms per millilitre (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
641055|NCT02322528|Primary|Visual Quality|Using a Shack Hartmann wavefront sensor, measured root mean square of wavefront aberrations caused by dynamic tear film changes.|baseline, 30 minutes, week 1, week 2|||microns||Standard Deviation|Mean
641056|NCT02322528|Primary|Ocular Surface Temperature of Both Eyes|Lotemax® is an FDA-approved ophthalmic suspension for the treatment of steroid-responsive inflammatory conditions which include dry eye associated ocular surface inflammation. Lotemax® will serve as a vehicle to study the changes in the inflammatory mediators on the surface of the eye as well as collect the inflammatory mediators for laboratory analysis, utilizing Luminex instrumentation and standard ELISA assays.|baseline, 30 minutes, week 1, week 2|||degrees celcius||Standard Deviation|Mean
641057|NCT02322216|Primary|Change From Baseline in Worst Ocular Itching Score During the 24 Hours Prior at Day 14|Severity of ocular itching was evaluated as the worst score observed in the past 24 hours prior to each study visit. Ocular itching was assessed by the participant on a scale from 0-4, where 0=None and 4=Incapacitating itch. One eye (study eye) contributed to the analysis.|Baseline, Day 14|Per Protocol Set with non-missing data||units on a scale||Standard Error|Mean
641058|NCT02321527|Primary|Number of Breast Cancer Participants With Sentinel Lymph Nodes (SLN) Identification Using the CEUS Technique|Following the Microbubble CEUS of ipsilateral axillary nodes, needle biopsy and I-125 seed placement, a single node/participant (biopsied node) will be included in the statistical evaluation. The technique determined as technically feasible if an enhancing node is visualized in at least 90% of the subjects and 80% concordance is achieved between imaging-guided biopsy and final surgical histopathology. If no enhancement is identified, the overlying skin will be massaged, and re-injection of contrast will be employed up to three times. If no contrast enhancement in lymphatics is observed, the case will be reported as a failure of the CEUS technique.|1 day|||Participants|||Count of Participants
641117|NCT02320214|Primary|Number of Participants With Observed Local Edema|Number of participants with observed edema by OB/GYN examination.|14 Days|female only||participants|||Number
641059|NCT02321436|Secondary|Mean Duration of Concomitant Non-drug Therapy Sessions.|The duration of non-drug therapy sessions that the subject received for UL spasticity in combination with injections of either Dysport® or placebo - up to and including the subject’s last study visit - were recorded in the Electronic Case Report Form (eCRF) as part of concomitant medications and therapies evaluation at all study visits (Prior and Concomitant Non-Drug Therapies eCRF page). Overall duration of concomitant therapies in the indication of “Post Stroke UL Spasticity” was computed for the period from first administration of Dysport® or placebo to last study visit. Concomitant non–drug therapies were defined as received any time during study (on or after the day of the first injection of Dysport® or placebo) regardless of the start or stop date. For each subject, overlapping sessions were defined as one therapy session using the earliest start date as the start date and the latest start date as the stop date.|From baseline up to Week 28|This analysis was performed on the safety population which includes all randomised subjects who received the study medication.||days||Standard Deviation|Mean
641060|NCT02321436|Secondary|Number of Concomitant Non-drug Therapy Sessions.|The number of non-drug therapy sessions that the subject received for UL spasticity in combination with injections of either Dysport® or placebo - up to and including the subject’s last study visit - were recorded in the Electronic Case Report Form (eCRF) as part of concomitant medications and therapies evaluation at all study visits (Prior and Concomitant Non-Drug Therapies eCRF page). All concomitant therapies in the indication of “Post Stroke UL Spasticity” were counted by subject from first administration of Dysport® or placebo to last study visit. Concomitant non–drug therapies were defined as received any time during study (on or after the day of the first injection of Dysport® or placebo) regardless of the start or stop date. For each subject, overlapping sessions were defined as one therapy session using the earliest start date as the start date and the latest start date as the stop date.|From baseline up to Week 28|This analysis was performed on the safety population which includes all randomised subjects who received the study medication.||Number of sessions|||Number
641061|NCT02321436|Secondary|Global Assessment of Changes at Last Visit|"Global assessment of changes was assessed by the investigator from Week 4 up to (but not including) the visit when the reinjection criteria were met. This endpoint was assessed by the investigator using a 5-point Likert scale to answer the following question: How does your patient feel compared to his/her condition at the first visit?
Much better
Better
No change
Worse
Much worse
Results are reported overall for subjects with both symptomatic and asymptomatic spasticity."|From Week 4 up to Week 28|This efficacy analysis was performed on the ITT population which includes all randomised subjects who provided informed consent. No data is available for subjects who met their reinjection criteria at Visit 2 (Week 4).||percentage of participants|||Number
641062|NCT02321436|Secondary|Mean Change in Fugl-Meyer Assessment for Evaluation of UL Motor Impairment.|"The Fugl-Meyer assessment is a validated tool for measuring motor functioning, balance, sensation, and joint functioning in the upper or lower limbs of subjects with post-stroke hemiplegia. The assessment scale is comprised of 155 items across 5 domains: motor functioning, sensory functioning, balance, joint range of motion and joint pain. For this study, only the UL motor part was assessed using the following criteria:
A. Upper Extremity (from 0 to 36) B. Wrist (from 0 to 10) C. Hand (from 0 to 14) D. Coordination / Speed (from 0 to 6)
Total motor function scores (A-D [from 0 to 66]) were calculated and LS mean changes from baseline up to (but not including) the visit when the reinjection criteria were met were reported.
Higher values for change from baseline indicated a better outcome."|From baseline up to Week 28|This analysis was performed on the ITT population and includes all randomised subjects who provided informed consent.||units on a scale||Standard Error|Least Squares Mean
641063|NCT02321436|Secondary|Mean Change in MAS of the Primary Targeted Muscle Group.|Increased muscle tone in the primary muscle group (selected by the investigator at the first visit, based on his/her clinical judgement and in agreement with the subject, in one of the following muscle groups: elbow flexors or pronators, wrist flexors, or finger flexors) was assessed using the MAS. Scale ranges from 0 (no increase in muscle tone) to 4 (affected part rigid in flexion or extension). Least Squares (LS) mean change from baseline to each subsequent visit (including the subject’s last study visit) of the MAS score is reported.|From baseline up to Week 28|This analysis was performed on the ITT population which includes all randomised subjects who provided informed consent.||units on a scale||Standard Error|Least Squares Mean
641064|NCT02321436|Primary|Time Between the Initial Injection and the Appearance of Reinjection Criteria as Evaluated by the Modified Ashworth Scale (MAS) and Spasticity Symptoms|"The appearance of increased muscle tone was assessed using the MAS (scale ranges from 0 [no increase in muscle tone] to 4 [affected part rigid in flexion or extension]). For confirmation of reinjection criteria appearance, a subject had to have a MAS score in the primary targeted muscle group of ≥2 and at least 1 of the following 4 criteria confirming signs of symptomatic spasticity in the UL:
A Numeric Pain Rating Scale (NPRS) pain score ≥ 4 (NPRS ranges from 0 [no pain] to 10 [severe pain])
An impact on passive function measured by a score of ≥ 1 on the 4-point Likert scale (scale ranges from 0 [no impact] to 3 [severe impact])
An impact on active function measured by a score of ≥ 1 on the 4-point Likert scale
An involuntary movements score ≥1 on the 4-point Likert scale in relevant upper limb.
Results are reported overall for subjects with both symptomatic and asymptomatic spasticity."|From Week 4 up to Week 28|This analysis was performed on the Intention-To-Treat (ITT) population which includes all randomised subjects who provided informed consent.||days||95% Confidence Interval|Median
641065|NCT02320838|Other Pre-specified|Skin Temperature|Skin temperature (ºC) will be recorded in all assessment times.|Baseline, during treatment at 15 min., immediately after treatment at 20 min., at 20 min. post-treatment, at 40 min. post-treatment|||ºC||Standard Deviation|Mean
641066|NCT02320838|Secondary|Tactile Threshold Post-treatment 40 Min.|The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton|at 40 min. post-treatment|||mN||Standard Deviation|Mean
641067|NCT02320838|Secondary|Tactile Threshold Post-treatment 20 Min.|The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton|at 20 min. post-treatment|||mN||Standard Deviation|Mean
641068|NCT02320838|Secondary|Baseline Tactile Threshold|The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton|Baseline at 0 min.|||mN||Standard Deviation|Mean
641069|NCT02320838|Secondary|Nerve Conduction Latency Post-treatment 40 Min.|The compound action potential latencies will be measured and will be expressed in ms.|at 40 min. post-treatment|||ms||Standard Deviation|Mean
670448|NCT01700387|Primary|Subject's Controlled Oral Word Association Test (COWAT) Scores at Visits 2-6 to Measure Cognitive Efficiency||12 Months||||||
641072|NCT02320838|Secondary|Thermal Pain Threshold Post-treatment 40 Min.|The heat pain threshold will be measured by a computer controlled thermo-foil heating device and will be expressed in ºC|at 40 min. post-treatment|||ºC||Standard Deviation|Mean
641073|NCT02320838|Secondary|Thermal Pain Threshold Post-treatment 20 Min.|The heat pain threshold will be measured by a computer controlled thermo-foil heating device and will be expressed in ºC|at 20 min. post-treatment|||ºC||Standard Deviation|Mean
641074|NCT02320838|Secondary|Baseline Thermal Pain Threshold|The heat pain threshold will be measured by a computer controlled thermo-foil heating device and will be expressed in ºC|Baseline at 0 min.|||ºC||Standard Deviation|Mean
641075|NCT02320838|Secondary|Mechanical Pain Threshold Post-treatment 40 Min.|The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton.|at 40 min. post-treatment|||N||Standard Deviation|Mean
641076|NCT02320838|Secondary|Mechanical Pain Threshold Post-treatment 20 Min.|The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton|at 20 min. post-treatment|||N||Standard Deviation|Mean
641077|NCT02320838|Secondary|Baseline Mechanical Pain Threshold|The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton|Baseline at 0 min.|||N||Standard Deviation|Mean
641078|NCT02320838|Secondary|Change From Baseline in Nerve Conduction Amplitude ( µV)|The compound action potential amplitudes ( µV) will be measured.|Baseline,immediately after treatment at 20 min..|||µV||Standard Error|Mean
641079|NCT02320838|Secondary|Change Current Density (mA/cm2)|Change in current density (mA/cm2), it will be recorded at 1 min. start of the treatment session and at 20 min of the same.|at 1 min. treatment session, at 20 min. treatment session|"Sham stimulation arm was not included in the analysis of change current density because in the Sham group no current was applied."||mA/cm2||Standard Deviation|Mean
641080|NCT02320838|Secondary|Perception Current Comfortability|Participants will choose the current treatment that has found more comfortable|At the end of the third experimental session, 3 days|"Sham stimulation arm was not included in the analysis of perception current comfortability because in the Sham group no current was applied."||Participants|||Count of Participants
641081|NCT02320838|Secondary|Habituation to Electrical Stimulation|The habituation to electrical stimulation along experimental session will be measured by recording the difference on current intensity (mA) at the start of the treatment session (1 min) and end of the same (20 min)|Start treatment session (1 min), end treatment session (20 min)|"Sham stimulation arm was not included in the analysis because for the habituation to the current the increased intensity was measured throughout the session and in the Sham group no current was applied"||mA||Standard Deviation|Mean
641082|NCT02320838|Primary|Tactile Threshold During Treatment|The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton|during treatment at 15 min.|||mN||Standard Deviation|Mean
641083|NCT02320838|Primary|Nerve Conduction Latency Immediately After Treatment|The compound action potential latencies will be measured and will be expressed in ms.|immediately after treatment at 20 min.|||ms||Standard Deviation|Mean
641084|NCT02320838|Primary|Thermal Pain Threshold During Treatment|The heat pain threshold will be measured by a computer controlled thermo-foil heating device and will be expressed in ºC|during treatment at 15 min.|||ºC||Standard Deviation|Mean
641085|NCT02320838|Primary|Mechanical Pain Threshold During Treatment|The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton|during treatment at 15 min|||N||Standard Deviation|Mean
641086|NCT02320721|Post-Hoc|Hypoglycemia (Any Hypoglycemia, Documented Symptomatic Hypoglycemia, Severe and/or Confirmed Hypoglycemia) Event Rate Per Participant Year: By Age Categorical Data During the 26 Weeks of Treatment|Hypoglycemia events were hypoglycemia of any category, severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); documented symptomatic hypoglycemia (symptoms of hypoglycemia with plasma glucose ≤3.9 mmol/L [70 mg/dL]); confirmed hypoglycemia (with or without symptoms of hypoglycemia and plasma glucose ≤3.9 mmol/L).|Baseline up to Week 26|Safety population.||events per participant year|||Number
641087|NCT02320721|Other Pre-specified|Hypoglycemia (Any Hypoglycemia, Documented Symptomatic Hypoglycemia, Severe and/or Confirmed Hypoglycemia) Event Rate Per Participant Year During the 26 Weeks of Treatment|Hypoglycemia events were hypoglycemia of any category, severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); documented symptomatic hypoglycemia (symptoms of hypoglycemia with plasma glucose ≤3.9 mmol/L [70 mg/dL]); confirmed hypoglycemia (with or without symptoms of hypoglycemia and plasma glucose ≤3.9 mmol/L).|Baseline up to Week 26|Safety population.||events per participant year|||Number
641088|NCT02320721|Other Pre-specified|Percentage of Participants With Hypoglycemia (Any Hypoglycemia, Documented Symptomatic Hypoglycemia, Severe and/or Confirmed Hypoglycemia) During the 26 Weeks of Treatment|Hypoglycemia events were hypoglycemia of any category, severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); documented symptomatic hypoglycemia (symptoms of hypoglycemia with plasma glucose ≤3.9 mmol/L [70 mg/dL]); confirmed hypoglycemia (with or without symptoms of hypoglycemia and plasma glucose ≤3.9 mmol/L).|Baseline up to Week 26|Safety population included all randomized participants who actually received at least 1 dose or part of a dose of investigational medicinal product (IMP) and analyzed according to the treatment actually received.||percentage of participants|||Number
641089|NCT02320721|Secondary|Percentage of Participants Requiring Rescue Therapy Over the 26 Weeks of Treatment|Routine fasting self-monitored plasma glucose (SMPG) and central laboratory FPG (and HbA1c after Week 14) values were used to determine the requirement of rescue medication. Threshold values at Week 14: FPG >200 mg/dL (11 mmol/L), or HbA1c >8.5%.|Baseline up to Week 26|ITT population.||percentage of participants|||Number
641090|NCT02320721|Secondary|Change in World Health Organization-5 (WHO-5) Well-Being Questionnaire Percentage Score From Baseline to Week 26|WHO-5 well-being index evaluates positive psychological well-being during the past 2 weeks and consists of 5 questions, each rated on a 6-point Likert scale from 0 (not present) to 5 (constantly present). Total raw score was transformed into a percentage score ranging from 0 (worst possible quality of life) to 100 (best possible quality of life).|Baseline, Week 26|ITT population. Here ‘Overall number of participants analyzed’ signifies participants with available data for this outcome measure.||scores on a scale||Standard Error|Least Squares Mean
641091|NCT02320721|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26|Adjusted LS means from multiple imputation approach including post baseline values during the 26-week randomized period.|Baseline, Week 26|ITT population. Here 'Overall number of participants analyzed' signifies participants with available data for this outcome measure.||mmol/L||Standard Error|Least Squares Mean
641092|NCT02320721|Secondary|Percentage of Participants With HbA1c <7.5% or <7.0% at Week 26 and No Severe and/or Confirmed (≤3.9 mmol/L [70 mg/dL]) Hypoglycemia During 26-Week Randomized Period|Severe hypoglycemia was an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Confirmed hypoglycemia was an event associated with plasma glucose ≤3.9 mmol/L (70 mg/dL).|Baseline up to Week 26|ITT population.||percentage of participants|||Number
641093|NCT02320721|Secondary|Percentage of Participants With HbA1c <7.5% or HbA1c <7% During 26-Week Randomized Period|Participants without any available HbA1c assessment at Week 26 were considered as non-responders in the analyses.|Baseline up to Week 26|ITT population.||percentage of participants|||Number
641094|NCT02320721|Secondary|Percentage of Participants With At Least One Severe and/ or Confirmed (≤3.9 mmol/L [70 mg/dL]) Hypoglycemia Occurring at Any Time of the Day During 26-Week Randomized Period|Estimated percentages from multiple imputation approach including data from the 26-week randomized period. Severe hypoglycemia was an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Confirmed hypoglycemia was an event associated with plasma glucose ≤3.9 mmol/L (70 mg/dL).|Baseline up to Week 26|ITT population.||percentage of participants|||Number
641095|NCT02320721|Secondary|Percentage of Participants With At Least One Severe and/ or Confirmed (≤3.9 mmol/L [70 mg/dL]) Nocturnal Hypoglycemia (00:00 to 05:59 Hours) During 26-Week Randomized Period|Estimated percentages from multiple imputation approach including data from the 26-week randomized period. Severe hypoglycemia was an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Confirmed hypoglycemia was an event associated with plasma glucose ≤3.9 mmol/L (70 mg/dL).|Baseline up to Week 26|ITT population.||percentage of participants|||Number
641096|NCT02320721|Secondary|Percentage of Participants With At Least One Severe and/ or Confirmed (≤3.9 mmol/L [70 mg/dL]) Nocturnal Hypoglycemia (22:00 to 08:59 Hours Next Morning) During 26-Week Randomized Period|Estimated percentages from multiple imputation approach including data from the 26-week randomized period. Severe hypoglycemia was an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Confirmed hypoglycemia was an event associated with plasma glucose ≤3.9 mmol/L (70 mg/dL).|Baseline up to Week 26|ITT population.||percentage of participants|||Number
641097|NCT02320721|Primary|Change in HbA1c From Baseline to Week 26|Adjusted least square (LS) means were obtained from analysis of covariance (ANCOVA) after multiple imputation of missing data including post baseline HbA1c data during the 26-week randomized period.|Baseline, Week 26|Intent-to-treat (ITT) population included all randomized participants regardless of whether the treatment kit was used, and analyzed according to the treatment group allocated by randomization.||percentage of hemoglobin||Standard Error|Least Squares Mean
641098|NCT02320695|Secondary|Mean Clinician Rating of Overall Wound Condition on Day 8|The clinician evaluated the wound using the following scale: 0 = minimal severity, 10 = maximal severity.|Day 8|The Intent-to-Treat (ITT) analysis population included all randomized subjects who had initiated the tape-stripping procedures.||units on a scale||Standard Deviation|Mean
641099|NCT02320695|Secondary|Mean Clinician Rating of Overall Wound Condition on Day 1|The clinician evaluated the wound using the following scale: 0 = minimal severity, 10 = maximal severity.|Day 1|The Intent-to-Treat (ITT) analysis population included all randomized subjects who had initiated the tape-stripping procedures.||units on a scale||Standard Deviation|Mean
641100|NCT02320695|Primary|Mean Change From Post-Tape Stripping in Subject Assessment of Stinging Sensation One Minute After Investigational Product Application|The stinging sensation was assessed by the subject using the following scale: 0 = no stinging sensation, 1 = mild stinging sensation, 2 = moderate stinging sensation, and 3 = severe stinging sensation at post-tape stripping and one minute after investigational product application. Change from post-tape striping was calculated as the subject assessment of stinging sensation at one minute after investigational product application minus the subject assessment of stinging sensation at post-tape stripping.|Post-tape stripping to one minute after investigational product application|Analysis was based on all randomized subjects who initiated the tape-stripping procedures and perceived sting sensation immediately after the application of alcohol.||units on a scale||Standard Deviation|Mean
641101|NCT02320695|Primary|Mean Change From Post-Tape Stripping in Subject Assessment of Stinging Sensation Immediately After Investigational Product Application|The stinging sensation was assessed by the subject using the following scale: 0 = no stinging sensation, 1 = mild stinging sensation, 2 = moderate stinging sensation, and 3 = severe stinging sensation at post-tape stripping and immediately after product application. Change from post-tape striping was calculated as the subject assessment of stinging sensation immediately after investigational product application minus the subject assessment of stinging sensation at post-tape stripping.|Post-tape stripping to immediately after investigational product application|Analysis was based on all randomized subjects who initiated the tape-stripping procedures and perceived sting sensation immediately after the application of alcohol.||units on a scale||Standard Deviation|Mean
641102|NCT02320396|Secondary|Percentage of Participants With Impression Assessments of “Better” or “Much Better” as Assessed Participants at Week 2|The participant evaluated their symptoms of allergic rhinitis at the end of the study (2 week visit or discontinuation visit) compared with those at the start of the study period (based on their recollection/memory of their symptoms, no formal baseline assessment) and recorded in their Subject Allergy Diary their impression of study drug on effect according to 6 grades: Much better, Better, Slightly better, Unchanged, Worse, or Unevaluable. The percentage of participants with assessments of “Better” and “Much better” graded by the participant (Participant’s Impression Rate) was reported and analyzed using Odds Ratio analysis.|From Baseline to Week 2|Participants in the FAS (all randomized participants who took ≥1 dose of study treatment) with available impression data.||percentage of participants|||Number
641118|NCT02320214|Primary|Number of Participants With Observed Local Erythema|Number of participants with observed erythema by OB/GYN examination.|14 Days|female only||participants|||Number
641103|NCT02320396|Secondary|Percentage of Participants With Impression Assessments of “Better” or “Much Better” as Assessed by the Investigator at Week 2|The investigator assessed the participant’s symptoms of allergic rhinitis and nasal findings at the end of the study (2 week visit or discontinuation visit) compared with those at the start of the study period (based on their recollection/memory of the participant’s symptoms, no formal baseline assessment) and evaluated their impression of study drug on effect according to 6 grades: Much better, Better, Slightly better, Unchanged, Worse, or Unevaluable. The evaluation result and reason for judgment (if needed) was recorded in the participant’s case report form. The investigator’s impression was evaluated based on the symptoms for allergic rhinitis, nasal findings and participant’s own impression at Week 2. The percentage of participants with assessments of “Better” and “Much better” graded by the investigator (Investigator’s Impression Rate) was reported and analyzed using Odds Ratio analysis.|From Baseline to Week 2|Participants in the FAS (all randomized participants who took ≥1 dose of study treatment) with available impression data.||percentage of participants|||Number
641104|NCT02320396|Secondary|Change From Baseline in Interference With Daily Activities Score at Week 1, Week 2, and During 2 Weeks of Therapy|Interference of allergic rhinitis symptoms with overall daily activities (such as work, study, housekeeping, sleep, or outing) was rated by the participant according to the following scale: 0=none, 1= symptoms cause few troubles, 2=symptoms cause intermediate problems between 1 and 3, 3=nasal symptoms cause painful and complicating daily life, or 4 = symptoms make daily activities impossible. Interference with daily activities scores ranged from 0 to 4 maximum, with a higher score indicating greater interference with daily activities. Baseline measurement was an average of scores for 3 days prior to treatment. Post-baseline measurement for Week 1 was an average of scores from Day 1 to Day 7. Post-BL measurement for Week 2 was an average of scores from Day 8 to Day 13. Post-BL measurement for 2 week Average was an average of scores from Day 1 to Day 13. Change from BL = Post BL measurement – BL measurement.|Baseline, Day 1 to 7 (Week 1 average), Day 8 to 13 (Week 2 average), Day 1 to Day 13 (Weeks 1 through 2 average) of double-blind treatment|The FAS; all randomized participants who took ≥1 dose of study treatment, and have a BL (average of score for 3 days prior to treatment) observation or one post BL observation.||units on a scale||95% Confidence Interval|Least Squares Mean
641105|NCT02320396|Secondary|Change From Baseline in Eye Symptoms (Pruritus, Watering Eyes and the Worse One of Either Pruritus or Watering Eyes) During 2 Weeks of Therapy|Eye symptoms rated in the participant’s diary included eye pruritis (eye itching scored from 0 [none] to 4 [severe eye itching, requiring frequent rubbing of eye]) and watering eyes (scored from 0 [none] to 4 [severe eye watering requiring frequent wiping of eyes]). Eye symptom scores ranged from 0 to 4, with a higher score indicating greater severity of symptom. The change from baseline in eye pruritis, eye watering, and the worse one of either eye symptom were reported. BL measurement was an average of scores for 3 days prior to treatment. Post-BL measurement for 2 week Average was an average of scores from Day 1 to Day 13. Change from BL = Post BL measurement – BL measurement.|Baseline, Day 1 to Day 13 (Weeks 1 through 2 average)|The FAS; all randomized participants who took ≥1 dose of study treatment, and have a BL (average of score for 3 days prior to treatment) observation or one post BL observation.||units on a scale||95% Confidence Interval|Least Squares Mean
641106|NCT02320396|Secondary|Change From Baseline to Week 2 in Eye Symptoms (Pruritus, Watering Eyes and the Worse One of Either Pruritus or Watering Eyes)|Eye symptoms rated in the participant’s diary included eye pruritis (eye itching scored from 0 [none] to 4 [severe eye itching, requiring frequent rubbing of eye]) and watering eyes (scored from 0 [none] to 4 [severe eye watering requiring frequent wiping of eyes]). Eye symptom scores ranged from 0 to 4, with a higher score indicating greater severity of symptom. The change from baseline in eye pruritis, eye watering, and the worse one of either eye symptom were reported. Baseline measurement was an average of scores for 3 days prior to treatment. Post-BL measurement for Week 2 was an average of scores from Day 8 to Day 13. Change from BL = Post BL measurement – BL measurement.|Baseline, Day 8 to 13 (Week 2) of double-blind treatment|The FAS; all randomized participants who took ≥1 dose of study treatment, and have a BL (average of score for 3 days prior to treatment) observation or one post BL observation.||units on a scale||95% Confidence Interval|Least Squares Mean
641107|NCT02320396|Secondary|Change From Baseline to Week 1 in Eye Symptoms (Pruritus, Watering Eyes and the Worse One of Either Pruritus or Watering Eyes)|Eye symptoms rated in the participant’s diary included eye pruritis (eye itching scored from 0 [none] to 4 [severe eye itching, requiring frequent rubbing of eye]) and watering eyes (scored from 0 [none] to 4 [severe eye watering requiring frequent wiping of eyes]). Eye symptom scores ranged from 0 to 4, with a higher score indicating greater severity of symptom. The change from baseline in eye pruritis, eye watering, and the worse one of either eye symptom were reported. Baseline measurement was an average of scores for 3 days prior to treatment. Post-baseline measurement for Week 1 was an average of scores from Day 1 to Day 7. Change from BL = Post BL measurement – BL measurement.|Baseline, Day 1 to 7 (Week 1 average) of double-blind treatment|The FAS; all randomized participants who took ≥1 dose of study treatment, and have a BL (average of score for 3 days prior to treatment) observation or one post BL observation.||units on a scale||95% Confidence Interval|Least Squares Mean
641108|NCT02320396|Secondary|Change From Baseline in Each Nasal Symptom Sub-Score (Sneezing, Rhinorrhea, Nasal Congestion and Nasal Itching) During 2 Weeks of Therapy|Nasal symptoms sub-scores rated in the participant’s diary included sneezing (daily frequency of attacks scored from 0 [<1 time or “none”] to 4 [≥21 times]), rhinorrhea (daily frequency of blowing nose scored from 0 [<1 time or “none”] to 4 [≥21 times]), nasal congestion (scored from 0 [no nasal blockage] to 4 [completely obstructed all day]), and nasal itching (scored from 0 [none] to 4 [nose is itchy, requiring frequent rubbing or blowing nose). Nasal symptom sub-scores ranged from 0 to 4, with a higher score indicating more frequent/severe nasal symptoms. BL measurement was an average of scores for 3 days prior to treatment (during Confirmation of Symptom Period). Post-BL measurement for 2 week Average was an average of scores from Day 1 to Day 13. Change from BL = Post BL measurement – BL measurement.|Baseline, Day 1 to Day 13 (Weeks 1 through 2 average)|The FAS; all randomized participants who took ≥1 dose of study treatment, and have a BL (average of score for 3 days prior to treatment) observation or one post BL observation.||units on a scale||95% Confidence Interval|Least Squares Mean
641119|NCT02319824|Secondary|Transferred NY-ESO-1-specific T Cells Based on Flow Cytometry Using Major Histocompatibility Complex Tetramers|Over 5% tet+ cells at 6 weeks? Patients may have detectable NY-ESO-1 specific T cells by MHC tetramers but if they are less than 5% this will be considered negative.|Up to 6 weeks post-treatment|||Participants|||Count of Participants
641109|NCT02320396|Secondary|Change From Baseline to Week 2 in Each Nasal Symptom Sub-Score (Sneezing, Rhinorrhea, Nasal Congestion and Nasal Itching)|Nasal symptoms sub-scores rated in the participant’s diary included sneezing (daily frequency of attacks scored from 0 [<1 time or “none”] to 4 [≥21 times]), rhinorrhea (daily frequency of blowing nose scored from 0 [<1 time or “none”] to 4 [≥21 times]), nasal congestion (scored from 0 [no nasal blockage] to 4 [completely obstructed all day]), and nasal itching (scored from 0 [none] to 4 [nose is itchy, requiring frequent rubbing or blowing nose). Nasal symptom sub-scores ranged from 0 to 4, with a higher score indicating more frequent/severe nasal symptoms. BL measurement was an average of scores for 3 days prior to treatment (during Confirmation of Symptom Period). Post-BL measurement for Week 2 was an average of scores from Day 8 to Day 13. Change from BL = Post BL measurement – BL measurement.|Baseline, Day 8 to 13 (Week 2 average) of double-blind treatment|The FAS; all randomized participants who took ≥1 dose of study treatment, and have a BL (average of score for 3 days prior to treatment) observation or one post BL observation.||units on a scale||95% Confidence Interval|Least Squares Mean
641110|NCT02320396|Secondary|Change From Baseline to Week 1 in Each Nasal Symptom Sub-Score (Sneezing, Rhinorrhea, Nasal Congestion and Nasal Itching)|Nasal symptoms sub-scores rated in the participant’s diary included sneezing (daily frequency of attacks scored from 0 [<1 time or “none”] to 4 [≥21 times]), rhinorrhea (daily frequency of blowing nose scored from 0 [<1 time or “none”] to 4 [≥21 times]), nasal congestion (scored from 0 [no nasal blockage] to 4 [completely obstructed all day]), and nasal itching (scored from 0 [none] to 4 [nose is itchy, requiring frequent rubbing or blowing nose). Nasal symptom sub-scores ranged from 0 to 4, with a higher score indicating more frequent/severe nasal symptoms. BL measurement was an average of scores for 3 days prior to treatment (during Confirmation of Symptom Period). Post-BL measurement for Week 1 was an average of scores from Day 1 to Day 7. Change from BL = Post BL measurement – BL measurement.|Baseline, Day 1 to 7 (Week 1 average) of double-blind treatment|The FAS; all randomized participants who took ≥1 dose of study treatment, and have a BL (average of score for 3 days prior to treatment) observation or one post BL observation.||units on a scale||95% Confidence Interval|Least Squares Mean
641111|NCT02320396|Secondary|Change From Baseline in TNSS for Week 1 and Week 2 of Double-blind Treatment|The TNSS was used to evaluate participant nasal symptoms of: sneezing (daily frequency of attacks scored from 0 [<1 time or “none”] to 4 [≥21 times]), rhinorrhea (daily frequency of blowing nose scored from 0 [<1 time or “none”] to 4 [≥21 times]), nasal congestion (scored from 0 [no nasal blockage] to 4 [completely obstructed all day]), and nasal itching (scored from 0 [none] to 4 [nose is itchy, requiring frequent rubbing or blowing nose) as rated in the participant’s diary. The TNSS was the sum of the 4 nasal symptom sub-scores. TNSS scores ranged from 0 to 16, with a higher score indicating more frequent/severe nasal symptoms. Baseline (BL) measurement was an average of scores for 3 days prior to treatment (during Confirmation of Symptom Period). Post-BL measurement for Week 1 was an average from Day 1 to Day 7 and post-BL measurement for Week 2 was an average from Day 8 to Day 13. Change from BL = Post BL measurement – BL measurement.|Baseline, Day 1 to 7 (Week 1 average), Day 8 to 13 (Week 2 average) of double-blind treatment|The FAS; all randomized participants who took ≥1 dose of study treatment, and have a BL (average of score for 3 days prior to treatment) observation or one post BL observation.||units on a scale||95% Confidence Interval|Least Squares Mean
641112|NCT02320396|Primary|Number of Participants Who Discontinue Study Drug Due to an AE|An AE was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that was temporally associated with the use of the Sponsor’s product, was also an AE.|Up to 2 weeks|APaT; all participants who received ≥1 dose of study treatment.||participants|||Number
641113|NCT02320396|Primary|Number of Participants Who Experience at Least One Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that was temporally associated with the use of the Sponsor’s product, was also an AE.|Up to 4 weeks (Up to 2 weeks after last dose of study drug)|All Participants as Treated (APaT); all participants who received ≥1 dose of study treatment.||participants|||Number
641114|NCT02320396|Primary|Change From Baseline in Total Nasal Symptom Score (TNSS) During 2 Weeks of Therapy|The TNSS was used to evaluate participant nasal symptoms of: sneezing (daily frequency of attacks scored from 0 [<1 time or “none”] to 4 [≥21 times]), rhinorrhea (daily frequency of blowing nose scored from 0 [<1 time or “none”] to 4 [≥21 times]), nasal congestion (scored from 0 [no nasal blockage] to 4 [completely obstructed all day]), and nasal itching (scored from 0 [none] to 4 [nose is itchy, requiring frequent rubbing or blowing nose) as rated in the participant’s diary. The TNSS was the sum of the 4 nasal symptom sub-scores. TNSS scores ranged from 0 to 16, with a higher score indicating more frequent/severe nasal symptoms. Baseline (BL) measurement was an average of scores for 3 days prior to treatment (during Confirmation of Symptom Period). Post-BL measurement was an average from Day 1 to Day 13 (2 week average). Change from BL = Post BL measurement – BL measurement.|Baseline, Day 1 to Day 13 (Weeks 1 through 2 average) of double-blind treatment|The Full Analysis Set (FAS); all randomized participants who took ≥1 dose of study treatment, and have a BL (average of score for 3 days prior to treatment) observation or one post BL observation (average score of 2 weeks).||units on a scale||95% Confidence Interval|Least Squares Mean
641115|NCT02320227|Primary|Number of Participants With Observed Local Edema|Number of participants with observed edema by OB/GYN examination.|14 days|||participants|||Number
641116|NCT02320227|Primary|Number of Participants With Observed Local Erythema|Number of participants with observed local erythema by OB/GYN examination.|14 Days|||participants|||Number
678084|NCT01601977|Secondary|Exacerbation Frequency|patient reported exacerbations following 6 weeks of device usage|6 weeks|||exacerbations|||Number
641121|NCT02319824|Primary|Incidence of Adverse Events Measured by the National Cancer Institute Common Terminology Criteria for Adverse Events Version (v)4.03|CTCAE v4.03|Up to 12 weeks post-treatment|treated patients||participants|||Number
641122|NCT02319668|Secondary|Total Number of Recoverable Viable Bacteria in the Aerosol Generated During Dental Prophylaxis|Thick settle blood agar plates (supplemented with 5% [volume by volume v/v]) defibrinated horse blood) were used to determine the bacterial load of the aerosol. Thirty (30) minutes prior to the participants had their procedure (dental prophylaxis), a total of 5 settle plates with lids removed were placed at set positions around the dental surgery. After 30 minutes, the settle plates lids were replaced. This was repeated during the dental prophylaxis procedure using 5 fresh settle plates. All plates were then sealed with parafilm and transported for incubation in an anaerobic chamber at 37°C for 3 days. The plates were inspected daily to access growth and after 3 days removed and stored at 4°C for subsequent colony enumeration and Colony Forming Unit/mL (CFU/mL) calculation|At Baseline|ITT (N=38) defined as all the participants who were randomised, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.||log (10) CFU/mL||Standard Deviation|Mean
641123|NCT02319668|Secondary|Area Under the Curve (AUC) for the Total Number of Plaque Bacteria in the Mouth Post Implant Surgery|The examiner identified three plaque sampling sites as follows: surgical site, contralateral site to the surgical site and tongue. An individual cotton swab was used at each identified site for up to 20 seconds in order to harvest a plaque sample and immediately be placed into 1mL phosphate buffered saline in a sterile Eppendorf tube. The samples were analysed using quantitative polymerase chain reaction (qPCR) which determined the total number of bacteria in a sample by quantifying the number of 16S ribosomal ribonucleic acid (rRNA) genes in the sample. The AUC of the total count of detectable plaque bacteria was calculated using trapezoidal rule in the time range from immediately post implant surgery to 7 days post implant surgery|Up to 7 days post implant surgery|ITT (N=38) defined as all the participants who were randomised, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.||log (10) CFE × Day||Standard Deviation|Mean
641124|NCT02319668|Secondary|Total Number of Detectable Plaque Bacteria Sampled at Implant Surgery (at Pre-rinse, Pre, Mid and Post Implant Surgery) and Post Implant Surgery (at Day 1 and 7)|The examiner identified three plaque sampling sites as follows: surgical site, contralateral site to the surgical site and tongue. An individual cotton swab was used at each identified site for up to 20 seconds in order to harvest a plaque sample and immediately be placed into 1mL phosphate buffered saline in a sterile Eppendorf tube. The samples were analysed using quantitative polymerase chain reaction (qPCR) which determined the total number of bacteria in a sample by quantifying the number of 16S ribosomal ribonucleic acid (rRNA) genes in the sample.|At Day 0 (pre-rinse, pre, mid and post implant surgery), Day 1 and 7|ITT (N=38) defined as all the participants who were randomised, received the study treatment at least once and provided at least one post-baseline assessment of efficacy. n was number of participants evaluated at specific endpoint.||log (10) CFE||Standard Deviation|Mean
641125|NCT02319668|Primary|Total Number of Detectable Plaque Bacteria Sampled 3 Days Post Implant Surgery|The examiner identified three plaque sampling sites as follows: surgical site, contralateral site to the surgical site and tongue. An individual cotton swab was used at each identified site for up to 20 seconds in order to harvest a plaque sample and immediately be placed into 1mL phosphate buffered saline in a sterile Eppendorf tube. The samples were analysed using quantitative polymerase chain reaction (qPCR) which determined the total number of bacteria in a sample by quantifying the number of 16S ribosomal ribonucleic acid (rRNA) genes in the sample. The number of bacteria in each of the three identified plaque sampling sites (surgical site, contralateral site to the surgical site and tongue) for each participant were summed to calculate the total number of bacteria for each participant.|At Day 3|Intent to treat (ITT) population (N=38): defined as all the participants who were randomised, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.||log(10) colony forming equivalents (CFE)||Standard Deviation|Mean
641126|NCT02319525|Secondary|Feasibility (Number of Participants Rating the Feasibility of Using Decision-aid or Pamphlet- Referred to as Education Guide in This Statement)|"Feasibility of the decision-aid vs. pamphlet was assessed using a single statement The education guide was easy to use. Patients rated this on 5-point ordinal scale ranging from “strongly agree” to “strongly disagree” (response options were: strongly agree, agree, neither agree nor disagree, disagree, strongly disagree). The number of patients was compared between the two treatment arms."|After viewing the guide or standard hand-out on the same visit as the intervention (preferred) (usually within 1 week)|One patient from pamphlet group did not respond to this question, therefore valid responses from pamphlet were 146, not 147||Participants|||Count of Participants
641127|NCT02319525|Secondary|"Acceptability (Number of Participants Rating Each Statement as Excellent)"|"Acceptability of the decision-aid (information quality and quantity, presentation style and usefulness) was assessed using a validated acceptability survey on 4-point scale ranging from “excellent” to “poor” (response options were: excellent, good, fair and poor). The number of patients rating each of the five statements as excellent (vs. other ratings) was compared between the two treatment arms."|After viewing the guide or standard hand-out on the same visit as the intervention (preferred) (usually within 1 week)|||Participants|||Count of Participants
641141|NCT02319148|Secondary|Number of Participants Who Used at Least 1 Concomitant Medication|Participants were to abstain from all concomitant treatments, except for the treatment of AEs. Treatments taken after the first dose of study treatment were documented as concomitant treatments.|Baseline up to Day 15 (final study evaluation)|The safety analysis population included all participants who received the study medication.||participants|||Number
641142|NCT02319148|Secondary|Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings|ECG parameters included PR interval, QRS interval, and corrected QT interval using Fridericia's formula (QTcF). Criteria for ECG changes meeting potential clinical concern included: PR interval greater than or equal to (>=)300 milliseconds (msec) or >=25% increase when baseline is greater than (>)200 msec and >=50% increase when baseline is less than or equal to (≤)200 msec; QRS interval >=140 msec or >=50% increase from baseline (IFB); and QTcF >=450 msec or >=30 msec increase. The number of participants with potentially clinically significant ECG findings at any visit were reported.|Pre-dose (Periods 1 and 2), 4, 72 and 96 hours post-dose in Period 2|The safety analysis population included all participants who received the study medication; n=number of participants evaluated against criteria.||participants|||Number
641128|NCT02319525|Secondary|Analysis of Audiotaped Physician-patient Interaction (Using the Active Patient Participation Coding Scheme (APPC)): Doctor Patient-centered Communication|This was done by analyzing the audio-recorded patient-physician discussion in patients with current lupus nephritis flare. The APCC is a validated instrument to measure ‘active patient participation.’ APCC assesses indicators and facilitators of patient participation. The unit of coding is the utterance, the oral analogue of a sentence. The range is 0 to unlimited. Patient participation is measured by the number of questions, number of concerns expressed, and act of assertiveness (e.g., preferences, introducing topics, making requests). These are ‘active’ forms of participation because of their influence on clinician behavior and the structure and content of the consultation. The APPC also assess clinician behaviors that facilitate and support patient participation, partnership-building and supportive talk (e.g., reassurance, empathy). We present doctor patient-centered communication. higher scores indicates better patient participation and communication.|After viewing the guide or standard hand-out on the same visit as the intervention (preferred) (usually within 1 week)|Only participants having a current lupus nephritis and requiring immunosuppressive medication change/initiation or participants with newly diagnosed lupus nephritis starting an immunosuppressive medication, who also agreed for an audio-recorded conversation.||units on a scale||Standard Deviation|Mean
641129|NCT02319525|Secondary|Patient Physician Communication (Interpersonal Processes of Care (IPC)|This was assessed using the interpersonal processes of care (IPC), an 18-item validated patient-reported measure of patient-physician communication and care processes. The score ranges from 18 (worst) to 90 (best) and the scale is a patient-reported measure of patient-physician communication and care processes.|After viewing the guide or standard hand-out on the same visit as the intervention (preferred) (usually within 1 week)|All participants who received either the Decision Aid or Pamphlet.||units on a scale||Standard Deviation|Mean
641130|NCT02319525|Secondary|Control Preferences Scale: Patient Participation in Decision-making|This scale assessed how much decision-making control they would like to have versus actually experienced. There are 5 responses for 5 control options: active, active shared, collaborative, passive shared and passive, which were collapsed into active (active, active shared), collaborative, and passive (passive shared and passive), as previously (and pre-specified). Concordance was assessed between desired and actual role played by each patient. We present these data for patients with current flare only, since only they were making a decision about the immunosuppressive drugs; patients with past lupus flare were not included in the denominator.|After viewing the guide or standard hand-out on the same visit as the intervention (preferred) but before treatment decision-making (usually within 1 week)|Only participants having a current lupus nephritis and requiring immunosuppressive medication change/initiation or participants with newly diagnosed lupus nephritis starting an immunosuppressive medication.||participants|||Number
641131|NCT02319525|Primary|Informed Choice (Validated Instruments for Values Regarding Immunosuppressives, Knowledge About Immunosuppressives, and Treatment Decision-making)|Concordance between values related (for or against starting) immunosuppressive drugs with patients’ decision (to start or not start) immunosuppressive drugs, in those with adequate knowledge about benefits/harms of immunosuppressive drugs, assessed using validated instruments for values regarding immunosuppressive drugs, knowledge about immunosuppressive drugs, and treatment decision-making (patient’s decision to start immunosuppressive drug).|After viewing the guide or standard hand-out on the same visit as the intervention (preferred) but before treatment decision-making (usually within 1 week)|All participants who received either the Decision Aid or Pamphlet.||participants|||Number
641132|NCT02319525|Primary|Change From Baseline in Decisional Conflict Scale Scores|Patient self-administered, validated measure of decisional conflict, most commonly used as the primary outcome in RCTs of decision aids (change score). The score ranges from 0 (no decisional conflict) to 100 (extreme decisional conflict). Decisional conflict represents a state of uncertainty about a choice or course of action and is more likely in situations involving high-stakes choices with important potential gains and losses, value tradeoffs in selecting a choice or a course of action (vs. the alternative) or uncertain outcomes.|Baseline and after viewing the decision-aid or the standard hand-out (pamphlet) on the same visit as the intervention (preferred) but before treatment decision-making (usually within 1 week)|All participants who received either the Decision Aid or Pamphlet||units on a scale||Standard Deviation|Mean
641133|NCT02319486|Primary|Event Free Survival Rate|measure the event free survival rate for the patients at 18 months: patients that without tumor relapse or metastasis|18 months|||participants|||Number
641134|NCT02319317|Secondary|Driving Citations and Crashes|Difference between the intervention and control group on driving citations and crashes.|Baseline (Study Visit 1) through Study Visit 4 (around 6 months).||||||
641135|NCT02319317|Secondary|Self-report Driving Behaviors|Difference between the intervention and control group on self-report measures of driving behaviors.|Baseline (Study Visit 1) through Study Visit 4 (around 6 months).||||||
641136|NCT02319317|Secondary|Simulated Driving Performance|Difference between the intervention and control group on the simulated driving assessment (measures of driving performance during the simulated experimental drives).|Baseline (Study Visit 1) through Study Visit 3||||||
641137|NCT02319317|Secondary|Adherence|Adherence among the intervention and control group to the intervention.|Baseline (Study Visit 1) through completion of the intervention.||||||
641138|NCT02319317|Secondary|Proportion of Participants Randomized|Proportion of participants screened, enrolled and randomized|Baseline (Study Visit 1)||||||
641139|NCT02319317|Primary|Retention of Participants|Proportion of participants enrolled who complete Study Visit 1, Study Visit 2, Study Visit 3 and Study Visit 4.|Baseline (Study Visit 1) through Study Visit 4 (around 6 months).|||Participants|||Count of Participants
641140|NCT02319148|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.|Baseline up to 28 days after last study drug administration|The safety analysis population included all participants who received the study medication.||participants|||Number
641143|NCT02319148|Secondary|Number of Participants With Potentially Clinically Significant Vital Signs Findings|Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: supine/sitting pulse rate <40 or >120 beats per minute (bpm), standing pulse rate <40 or >140 bpm; systolic blood pressure (SBP) of >=30 millimeters of mercury (mm Hg) change from baseline in same posture or SBP <90 mm Hg, diastolic blood pressure (DBP) >=20 mmHg change from baseline in same posture or DBP <50 mm Hg.|Baseline up to Day 9|The safety analysis population included all participants who received the study medication; n=number of participants evaluated against criteria.||participants|||Number
641144|NCT02319148|Secondary|Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern|The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell [RBC] count, RBC morphology, platelet count, white blood cell [WBC] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen [BUN], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, alkaline phosphatase, uric acid, albumin, and total protein; urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, microscopy [if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase]); others (coagulation panel, circulating immune complex, and complement activation).|Baseline up to 28 days after last study drug administration|The safety analysis population included all participants who received the study medication.||participants|||Number
641145|NCT02319148|Secondary|Terminal Elimination Half-Life (t1/2) of PF-00489791|t1/2 is the time measured for the plasma concentration to decrease by one half.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after PF-00489791 administration|The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||hour||Standard Deviation|Mean
641146|NCT02319148|Secondary|Apparent Oral Clearance (CL/F) of PF-00489791|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after PF-00489791 administration|The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||milliliter per minute (mL/min)||Geometric Coefficient of Variation|Geometric Mean
641147|NCT02319148|Secondary|Apparent Volume of Distribution (Vz/F) of PF-00489791|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after PF-00489791 administration|The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||liter||Geometric Coefficient of Variation|Geometric Mean
641148|NCT02319148|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-00489791||Pre-dose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after PF-00489791 administration|The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||hour||Full Range|Median
641149|NCT02319148|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-00489791|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after PF-00489791 administration|The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng.hr/mL||Geometric Coefficient of Variation|Geometric Mean
641150|NCT02319148|Primary|Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-00489791|AUC is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after PF-00489791 administration|The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||nanogram*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
641151|NCT02319148|Primary|Maximum Observed Plasma Concentration (Cmax) of PF-00489791||Pre-dose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after PF-00489791 administration|The pharmacokinetic (PK) analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
641152|NCT02319031|Secondary|Number of Participants With Death, Serious Adverse Events (SAEs), Discontinuation Due to Adverse Events (AEs), Grade 3 or Grade 4 (Grade 3/4) AEs, and Grade 3/4 Laboratory Abnormalities|Serious adverse event (SAE) defined: a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Adverse event (AE) defined: any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. The degree of the adverse event or laboratory abnormality are evaluated by grades: Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. Grading as per using National Cancer Institute Common Terminology Criteria (NCI CTC) Version 3.0 criteria.|Date of First Dose of Study Drug to 7 Days post last dose of study drug (up to 13 weeks or 17 weeks depending on the randomized treatment group)|All treated participants: Enrolled participants who received at least 1 dose of study drug||participants|||Number
641176|NCT02317809|Secondary|Apparent Serum Clearance (CL/F) for Follicle-stimulating Hormone (FSH) and Luteinizing Hormone (LH)|Clearance is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained is influenced by the fraction of the dose absorbed and was expressed as volume (Liter) per unit of time (hour).|Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120, 168 hours post-dose in each period for FSH; Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120 hours post-dose in each period for LH|PK analysis set. Here “n” signifies those subjects who were evaluable for the specified hormone level in each arm, respectively.||Liter per hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
641153|NCT02319031|Secondary|Percent of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 4 (SVR4) and Follow-up Week 24 (SVR24)|SVR4, defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantitation (LLOQ), target detected (TD) or target not detected (TND) at follow-up Week 4. SVR24, defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantitation (LLOQ), target detected (TD) or target not detected (TND) at follow-up Week 24. SVR4 imputation was based on Next Value Carried Backwards (NVCB) approach. SVR24 imputation was based on missing being treated as non-responder. HCV RNA measurements were excluded after the start of non-study anti-HCV medication on treatment or during follow-up.|Follow-up Weeks 4 and 24|All treated participants: Enrolled participants who received at least 1 dose of study drug||percentage of participants||95% Confidence Interval|Number
641154|NCT02319031|Primary|Percent of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 12 (SVR12)|SVR12, defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantitation (LLOQ), target detected (TD) or target not detected (TND) at follow-up Week 12. SVR12 imputation was based on Next Value Carried Backwards (NVCB) approach. HCV RNA measurements were excluded after the start of non-study anti-HCV medication on treatment or during follow-up.|Follow-up Week 12|All treated participants: Enrolled participants who received at least 1 dose of study drug||percentage of participants||95% Confidence Interval|Number
641155|NCT02318940|Secondary|Arterial Puncture|Percentage of participants with Arterial puncture aspiration|intraoperative, an average of 1 hour|||percentage of participants|||Number
641156|NCT02318940|Secondary|Number of Attempts|Number of participants who succeeded in the installation of cvc in one, two, three, four or five attempts.|intraoperative, an average of 1 hour|||participants|||Number
641157|NCT02318940|Secondary|Successful Installation|Percentage of participants with successful installation of guide without difficulty in the femoral vein|intraoperative, an average of 1 hour|||percentage of participants|||Number
641158|NCT02318940|Primary|Installation on the First Try|Percentage of Participants with successful installation on the first transcutaneous passage of the glass needle|intraoperative, an average of 1 hour|||percentage of participants|||Number
641159|NCT02318693|Secondary|Change From Baseline in Percentage of Hypoglycemic Values (Glucose Sensor Readings: < 70, <60, <50 mg/dL)|Hypoglycemia, defined as low blood glucose, is a common side effect of medications used to treat diabetes mellitus type 2. The percentage of hypoglycemic corrected CGM readings (sensor glucose <70, <60, <50 mg/dL) over a 24-hour period were determined at baseline and Day 13. CGM values were corrected using a participant-administered finger-stick test for blood glucose. LS mean values were derived from a constrained longitudinal analysis model. A negative (-) change from baseline to Day 13 indicates improvement in occurrence of hypoglycemia.|Baseline (Day -2) and Day 13|The FAS population consisting of all randomized participants who received at least one dose of study treatment, with at least one post-randomization/post-treatment observation for the analysis, and with applicable baseline data was used for analysis.||Percent change||95% Confidence Interval|Least Squares Mean
641160|NCT02318693|Secondary|Change From Baseline in 24-hour Mean Glucose Level|The mean glucose level over 24-hours at Baseline and Day 13 was determined using CGM values corrected for participant-administered finger-stick values. LS mean values were derived from a constrained longitudinal analysis model. A negative (-) change from Baseline to Day 13 indicates improvement of the assessed outcome.|Baseline (Day -2) and Day 13|The FAS population consisting of all randomized participants who received at least one dose of study treatment, with at least one post-randomization/post-treatment observation for the analysis, and with applicable baseline data was used for analysis.||mg/dL||95% Confidence Interval|Least Squares Mean
641161|NCT02318693|Secondary|Change From Baseline in Maximum Incremental Postprandial Glucose Levels in Each Meal|The peak postprandial glucose level during the 3 hours post meal minus the preprandial glucose level 1 hour before meal was determined for corrected CGM values at Baseline and Day 13 for breakfast, lunch, and dinner. Meals were standardized with respect to total calories, and protein, fat, and carbohydrate composition as well as timing of administration. CGM values were corrected using a participant-administered finger-stick test for blood glucose. LS mean values were derived from a constrained longitudinal analysis model. A negative (-) change from baseline to Day 13 indicates better control of postprandial glucose.|Baseline (Day -2) and Day 13|The FAS population consisting of all randomized participants who received at least one dose of study treatment, with at least one post-randomization/post-treatment observation for the analysis, and with applicable baseline data was used for analysis.||mg/dL||95% Confidence Interval|Least Squares Mean
641162|NCT02318693|Secondary|Change From Baseline in the Standard Deviation of Blood Glucose Levels|SD is a popular metric for assessment of postprandial glucose swings. The SD of all glycemic excursions over 24 hours (i.e., total of 288 glucose values over 24 hours) was determined for Baseline and Day 13. Original values were obtained using CGM and corrected for blood glucose values obtained via participant-administered finger-stick. LS mean values were derived from a constrained longitudinal analysis model. A negative (-) change from Baseline to Day 13 indicates improvement of the assessed outcome.|Baseline (Day -2) and Day 13|The FAS population consisting of all randomized participants who received at least one dose of study treatment, with at least one post-randomization/post-treatment observation for the analysis, and with applicable baseline data was used for analysis.||mg/dL||95% Confidence Interval|Least Squares Mean
641163|NCT02318693|Primary|Change From Baseline in Mean Amplitude of Glycemic Excursions (MAGE) at Day 13|MAGE is a popular metric for assessment of major (e.g., postprandial) glucose swings. MAGE is calculated as the average of differences between consecutive glucose peaks and nadirs greater than 1 standard deviation (SD) of 24-hour mean glucose. In this assessment, glucose levels were determined using continuous glucose monitoring (CGM) over 24 hours at Baseline and Day 13; CGM values were further corrected for blood glucose values obtained via participant-administered finger-stick. Least squares (LS) means values were derived from a constrained longitudinal analysis model. A negative (-) change from Baseline to Day 13 indicates improvement of the assessed outcome.|Baseline (Day -2) and Day 13|The FAS population consisting of all randomized participants who received at least one dose of study treatment, with at least one post-randomization/post-treatment observation for the analysis, and with applicable baseline data was used for analysis.||mg/dL||95% Confidence Interval|Least Squares Mean
641189|NCT02317510|Secondary|Intra-operative Shoulder Pain|Group 1 and Group 2 Intra-operative shoulder pain|during operation time, up to 2 hours|All patients have gall bladder disease who are between 18-90 years old.||participants|||Number
641164|NCT02318303|Primary|Change in rTNSS From Baseline to End of Treatment|"Subjects were asked to assess rTNSS (reflective Total Nasal Symptom Score), ie, an evaluation of symptom severity over the past 12 hours prior to the recording of the score. The TNSS was defined as the sum of the subject-reported symptom severity scores for the following four nasal symptoms, recorded by each subject in the diary: rhinorrhea, sneezing, nasal congestion, nasal itching.
The total rTNSS scores for all four symptoms (i.e, the lowest possible score (0) and the highest possible score (12).)
The severity scale for each symptom evaluation was defined as follows:
0 = absent (no sign/symptom evident)
1 = mild (sign/symptom clearly present, but minimal awareness; easily tolerated)
2 = moderate (definite awareness of sign/symptom that is bothersome but tolerable)
3 = severe (sign/symptom that is hard to tolerate [i.e., causes interference with activities of daily living and/or sleeping])"|14 days|The full analysis set (FAS) included all randomized subjects who received at least one dose of randomized study medication and had at least one post-baseline primary efficacy assessment. This was the primary analysis set for efficacy analyses.||units on a scale||Standard Deviation|Mean
641165|NCT02317809|Secondary|Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) Titers for Luteinizing Hormone (LH)||Day 1 pre-dose up to follow-up visit (Day 18) for IMP intervention periods|Data could not be collected as there were no subjects with positive results for ADAs and NAbs.|||||
641166|NCT02317809|Secondary|Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) Titers for Follicle-stimulating Hormone (FSH)||Day 1 pre-dose up to follow-up visit (Day 18) for IMP intervention periods||08/2017||||
641167|NCT02317809|Secondary|Number of Subjects With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) for Luteinizing Hormone (LH)||Day 1 pre-dose up to follow-up visit (Day 18) for IMP intervention periods|Safety analysis set included all subjects who received at least 1 dose of the investigational medicinal product (IMP) (that is, either liquid formulation or freeze-dried formulation).||Subjects|||Number
641168|NCT02317809|Secondary|Number of Subjects With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) for Follicle-stimulating Hormone (FSH)||Day 1 pre-dose up to follow-up visit (Day 18) for IMP intervention periods.||08/2017||||
641169|NCT02317809|Secondary|Pain Visual Analogue Scale (VAS) Score|The severity of pain was evaluated by the subject and recorded using a 100 millimeter (mm) visual analogue scale (VAS) ranging from 0 to 100, where 0 mm = no pain and 100 mm = worst possible pain.|5 minutes, 1, 2, 4, 6, 12, and 24 hours post-dose in each period|Safety analysis set included all subjects who received at least 1 dose of the investigational medicinal product (IMP) (that is, either liquid formulation or freeze-dried formulation). Here “n” signifies those subjects who were evaluable for the specified time point in each arm, respectively.||mm||Standard Deviation|Mean
641170|NCT02317809|Secondary|Number of Subjects With Local Tolerability/Injection Site Reactions (ISRs)|Injection site was assessed by the study site staff for any local reaction (redness, swelling, bruising, and itching). Redness and bruising were scaled as None (no visible redness or bruising); Mild (less than or equal to [<=] 2.0 centimeters [cm] redness or bruising); Moderate (greater than [>] 2 to <=5.0 cm redness or bruising); Severe (>5.0 cm redness or bruising). Swelling was scaled as None (no swelling detected); Mild (palpable ‘firmness’ only); Moderate (<= 4 cm swelling); Severe (>4 cm swelling). Itching was scaled as None (no itching); Mild itching; Moderate itching and Severe itching. Only those scale categories which report at least 1 subject were presented.|5 minutes, 1, 2, 4, 6, 12, and 24 hours post-dose in each period|Safety analysis set included all subjects who received at least 1 dose of the investigational medicinal product (IMP) (that is, either liquid formulation or freeze-dried formulation). Here “n” signifies those subjects who were evaluable for the specified injection site reaction at the specified time point for each arm, respectively.||Subjects|||Number
641171|NCT02317809|Secondary|Serum Estradiol Levels|Data was planned to be presented as per the sequence of treatment received.|Screening (up to 28 days), Day 1 (pre-dose) and Day 8 in Period 1, Day 1 (pre-dose), Day 8 and follow-up (Day 18) in Period 2|Safety analysis set included all subjects who received at least 1 dose of the investigational medicinal product (IMP) (that is, either liquid formulation or freeze-dried formulation).||nanogram per liter (ng/L)||Standard Deviation|Mean
641172|NCT02317809|Secondary|Number of Subjects With Follicle Size Greater Than (>)13 Millimeter|Transvaginal ultrasound (TVUS) was performed to determine the follicle size and number.|Day 1 (pre-dose) up to follow-up visit (Day 18) for IMP intervention periods|Safety analysis set included all subjects who received at least 1 dose of the investigational medicinal product (IMP) (that is, either liquid formulation or freeze-dried formulation).||Subjects|||Number
641173|NCT02317809|Secondary|Number of Subjects With Treatment Emergent Adverse Events (TEAEs) Related to Laboratory Assessments, Vital Signs or Electrocardiogram Findings||Day 1 post-IMP administration up to follow-up visit (Day 18) for IMP intervention periods|Safety analysis set included all subjects who received at least 1 dose of the investigational medicinal product (IMP) (that is, either liquid formulation or freeze-dried formulation).||Subjects|||Number
641174|NCT02317809|Secondary|Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a subject, regardless of causal relationship with the treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs include both SAEs and non-serious AEs.|Day 1 post-IMP administration up to follow-up visit (Day 18) for IMP intervention periods|Safety analysis set included all subjects who received at least 1 dose of the investigational medicinal product (IMP) (that is, either liquid formulation or freeze-dried formulation).||Subjects|||Number
641175|NCT02317809|Secondary|Apparent Volume of Distribution During Terminal Phase (Vz/F) for Follicle-stimulating Hormone (FSH) and Luteinizing Hormone (LH)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired concentration. Apparent volume of distribution (Vz/F) is influenced by the fraction absorbed.|Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120, 168 hours post-dose in each period for FSH; Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120 hours post-dose in each period for LH|PK analysis set. Here “n” signifies those subjects who were evaluable for the specified hormone level in each arm, respectively.||Liter (L)||Geometric Coefficient of Variation|Geometric Mean
641177|NCT02317809|Secondary|Apparent Terminal Half-life (t1/2) for Follicle-stimulating Hormone (FSH) and Luteinizing Hormone (LH)|Terminal half-life is the time measured for the concentration to decrease by one half.|Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120, 168 hours post-dose in each period for FSH; Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120 hours post-dose in each period for LH|PK analysis set. Here “n” signifies those subjects who were evaluable for the specified hormone level in each arm, respectively.||Hour (h)||Geometric Coefficient of Variation|Geometric Mean
641178|NCT02317809|Secondary|Time to Reach the Maximum Serum Concentration (Tmax) for Follicle-stimulating Hormone (FSH) and Luteinizing Hormone (LH)||Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120, 168 hours post-dose in each period for FSH; Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120 hours post-dose in each period for LH|Pharmacokinetic (PK) analysis set: all randomized subjects who were treated with both liquid and freeze-dried formulations and had absence of relevant protocol violations, had availability of the primary target variables and successfully downregulated baseline levels of FSH and LH below 1.0 IU/L in both the screening and dedicated PK assays.||Hour (h)||Full Range|Median
641179|NCT02317809|Secondary|Apparent Terminal Elimination Rate Constant (Lambda[z]) for Follicle-stimulating Hormone (FSH) and Luteinizing Hormone (LH)|The elimination rate constant was obtained from linear regression of the terminal phase of the log transformed concentration-time data.|Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120, 168 hours post-dose in each period for FSH; Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120 hours post-dose in each period for LH|PK analysis set. Here “n” signifies those subjects who were evaluable for the specified hormone level in each arm, respectively.||Per Hour (1/hour)||Geometric Coefficient of Variation|Geometric Mean
641180|NCT02317809|Secondary|Baseline Corrected Area Under the Serum Concentration-time Curve From Time Tlast Extrapolated to Infinity (%AUCextra,Adj) for Follicle-stimulating Hormone (FSH) and Luteinizing Hormone (LH)|Area under the serum concentration-time curve from Tlast extrapolated to infinity given as a percentage of AUC0-inf. Data was not planned to be summarized if AUCextra,adj was less than 20%.|Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120, 168 hours post-dose in each period for FSH; Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120 hours post-dose in each period for LH|As per statistical analysis plan, data was not planned to be summarized because AUCextra,adj was below 20% for all the participants.|||||
641181|NCT02317809|Secondary|Baseline Corrected Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUC0-inf, Adj) for Follicle-stimulating Hormone (FSH) and Luteinizing Hormone (LH)||Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120, 168 hours post-dose in each period for FSH; Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120 hours post-dose in each period for LH|PK analysis set. Here “n” signifies those subjects who were evaluable for the specified hormone level in each arm, respectively.||International units*hour/liter (IU*h/L)||Geometric Coefficient of Variation|Geometric Mean
641182|NCT02317809|Primary|Baseline Corrected Maximum Serum Concentration (Cmax,Adj) for Luteinizing Hormone (LH)|Baseline-corrected Cmax (Cmax,adj) = Cmax – baseline concentration.|Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96 and 120 hours post-dose in each period|Pharmacokinetic (PK) analysis set: all randomized subjects who were treated with both liquid and freeze-dried formulations and had absence of relevant protocol violations, had availability of the primary target variables and successfully downregulated baseline levels of FSH and LH below 1.0 IU/L in both the screening and dedicated PK assays.||International units per liter (IU/L)||Geometric Coefficient of Variation|Geometric Mean
641183|NCT02317809|Primary|Baseline Corrected Maximum Serum Concentration (Cmax,Adj) for Follicle-Stimulating Hormone (FSH)|Baseline-corrected Cmax (Cmax,adj) = Cmax – baseline concentration|Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120 and 168 hours post-dose in each period|Pharmacokinetic (PK) analysis set: all randomized subjects who were treated with both liquid and freeze-dried formulations and had absence of relevant protocol violations, had availability of the primary target variables and successfully downregulated baseline levels of FSH and LH below 1.0 IU/L in both the screening and dedicated PK assays.||International units per liter (IU/L)||Geometric Coefficient of Variation|Geometric Mean
641184|NCT02317809|Primary|Baseline Corrected Area Under the Concentration-Time Curve From Zero to Last Quantifiable Concentration (AUC0-t,Adj) for Luteinizing Hormone (LH)|The AUC (0-t) was defined as the area under the serum concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration. Baseline-corrected AUC0-t (AUC0-t,adj) = AUC0-t – (baseline concentration * t).|Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96 and 120 hours post-dose in each period|Pharmacokinetic (PK) analysis set: all randomized subjects who were treated with both liquid and freeze-dried formulations and had absence of relevant protocol violations, had availability of the primary target variables and successfully downregulated baseline levels of FSH and LH below 1.0 IU/L in both the screening and dedicated PK assays.||International units*hour/liter (IU*h/L)||Geometric Coefficient of Variation|Geometric Mean
641185|NCT02317809|Primary|Baseline Corrected Area Under the Concentration-Time Curve From Zero to Last Quantifiable Concentration (AUC 0-t,Adj) for Follicle-Stimulating Hormone (FSH)|The AUC (0-t) was defined as the area under the serum concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration. Baseline-corrected AUC0-t (AUC0-t,adj) = AUC0-t – (baseline concentration * t).|Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120 and 168 hours post-dose in each period|Pharmacokinetic (PK) analysis set: All randomized subjects who were treated with both liquid and freeze-dried formulations and had absence of relevant protocol violations, had availability of the primary target variables and successfully down regulated baseline levels of FSH and LH below 1.0 IU/L in both the screening and dedicated PK assays.||International units*hour/liter (IU*h/L)||Geometric Coefficient of Variation|Geometric Mean
641186|NCT02317510|Secondary|Headache|Group 1 and Group 2 Headache|from end of the operation to postoperative 3 days|All patients have gall bladder disease who are between 18-90 years old.||participants|||Number
641187|NCT02317510|Secondary|Nausea/Vomiting|Group 1 and group 2 nausea/vomiting|from end of the operation to postoperative 1 day|All patients have gall bladder disease who are between 18-90 years old.||participants|||Number
641188|NCT02317510|Secondary|Urinary Retention|Group 1 and Group 2 Urinary retention|from end of the operation to postoperative 1 day|All patients have gall bladder disease who are between 18-90 years old||participants|||Number
641190|NCT02317510|Primary|Post-operative Shoulder Pain|Group 1 and Group 2 Post-operative shoulder pain|from end of the operation to postoperative 3 days|All patients have gall bladder disease who are between 18-90 years old||participants|||Number
641191|NCT02317510|Secondary|Post-operative Abdominal Pain 24th Hour|VAS score;Explain to the person that each number describe the intensity of his pain. Number 0 describe very happy and no pain and no hurt at all. Number 1 hurts just a little bit. And as te numbers gradually increase pain will increase. Number 10 describes the worst pain in his life. Ask the patient to choose the number that best describes how he is feeling and his pain.|pain at postoperative 24th hour|All patients have gall bladder disease who are between 18-90 years old.||units on a scale||Standard Deviation|Least Squares Mean
641192|NCT02317510|Secondary|Post-operative Abdominal Pain 12th Hour|VAS score;Explain to the person that each number describe the intensity of his pain. Number 0 describe very happy and no pain and no hurt at all. Number 1 hurts just a little bit. And as te numbers gradually increase pain will increase. Number 10 describes the worst pain in his life. Ask the patient to choose the number that best describes how he is feeling and his pain.|pain at postoperative 12th hour|All patients have gall bladder disease who are between 18-90 years old.||units on a scale||Standard Deviation|Least Squares Mean
641193|NCT02317510|Secondary|Post-operative Abdominal Pain 6th Hour|VAS score;Explain to the person that each number describe the intensity of his pain. Number 0 describe very happy and no pain and no hurt at all. Number 1 hurts just a little bit. And as te numbers gradually increase pain will increase. Number 10 describes the worst pain in his life. Ask the patient to choose the number that best describes how he is feeling and his pain.|pain at postoperative 6th hour|All patients have gall bladder disease who are between 18-90 years old.||units on a scale||Standard Deviation|Least Squares Mean
641194|NCT02317510|Secondary|Post-operative Abdominal Pain 4th Hour|VAS score ;Explain to the person that each number describe the intensity of his pain. Number 0 describe very happy and no pain and no hurt at all. Number 1 hurts just a little bit. And as te numbers gradually increase pain will increase. Number 10 describes the worst pain in his life. Ask the patient to choose the number that best describes how he is feeling and his pain.|pain at postoperative 4th hour|All patients have gall bladder disease who are between 18-90 years old.||units on a scale||Standard Deviation|Least Squares Mean
641195|NCT02317510|Secondary|Post-operative Abdominal Pain 2nd Hour|VAS score ;Explain to the person that each number describe the intensity of his pain. Number 0 describe very happy and no pain and no hurt at all. Number 1 hurts just a little bit. And as te numbers gradually increase pain will increase. Number 10 describes the worst pain in his life. Ask the patient to choose the number that best describes how he is feeling and his pain.|pain at postoperative 2nd hour|All patients have gall bladder disease who are between 18-90 years old.||units on a scale||Standard Deviation|Least Squares Mean
641196|NCT02317510|Secondary|Duration of Anaesthesia|Group 1 minimum 42 minutes and maximum 83 minutes.mean duration of anaesthesia 60.17 and Group 2 minimum 45 minutes and maximum 82 minutes mean duration of anaesthesia 60.23|up to 2 hours|All patients have gall bladder disease who are between 18-90 years old.||minutes||Standard Deviation|Mean
641197|NCT02317510|Primary|Duration of Operation|group 1:surgical operation time is 20 minutes minimum and maximum 55 minutes. Mean operation time 36.56 minutes group 2:surgical operation time is 24 minutes minimum and maximum 53 minutes. Mean operation time 30.75 minutes|up to 2 hours|All patients have gall bladder disease who are between 18-90 years old.||minutes||Standard Deviation|Mean
641281|NCT02314546|Secondary|Parental Observed Behavioral Distress Score|Measured by the accompanying parent using a Visual Analog Scale. The scale ranges from a minimum score of 0 (no distress at all) to a maximum of 10 (most distress possible).|1 minute post-administration|||units on a scale||Standard Deviation|Mean
641245|NCT02316470|Secondary|Rate of Study Participants With at Least One SAE (Serious Adverse Event)|percentage of study participants with at least one SAE starting up to Day 56 and up to Day 210|Day 56 and Day 210|Safety Population = study participants who received at least one study vaccination||percentage of participants||95% Confidence Interval|Number
641212|NCT02316769|Secondary|Time to Intubation|Number of patients intubated in less than 90 seconds|Intubation time was initiated at the time of entry of the study device beyond the teeth/gum line and the intubation time was stopped when the study device was removed beyond the same point.|||participants|||Number
641213|NCT02316769|Primary|Intubation Success on First Attempt as Measured by End Tidal Carbon Dioxide||participants were followed up to the point the video device is removed from the airway, classified as under 90 seconds.|||participants|||Number
641214|NCT02316678|Primary|Mortality Rate|"Incidence of death per 1000 person-years
Outcome Measure Time Frame:Follow-up was from the date that the participant first met the criteria for either prolonged corticosteroid use or new anti-TNF use until either the patient died, discontinued enrollment in Medicaid or Medicare Part A, B, or D, reached age 90, was newly diagnosed with other immune-mediated diseases or AIDS, or reached the end of the available data, whichever came first, assessed up to 13 years. Follow-up of patients with UC also ended if they were diagnosed with a fistula, as this would usually change the diagnosis to CD."|See Outcome Measure Description above|Patients treated with corticosteroids (CS) within the prior year and subsequently received either additional CS therapy meeting the definition of prolonged CS use or newly initiated anti-TNF therapy were included in the study.||events per 1000 person-years|||Number
641215|NCT02316613|Secondary|Number and Type of Hospitalization Associated With MabThera Perfusion|Number and type of hospitalization (a day hospitalization, short-lasting hospitalization, and short-stay hospitalization) was reported.|Up to 6 years|All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included.||hospitalizations|Participants||Number
641216|NCT02316613|Secondary|Function Assessment of Chronic Illness Therapy–General (FACT-G) With Lymphoma-Specific Additional Concerns Subscale (Lym) Total Score|"The FACT-G with Lymphoma-Specific Additional Concerns Subscale (Lym) total score was calculated by adding the score obtained on the FACT-G (physical well-being, scored 0–28; social well-being, scored 0–28; functional well-being, scored 0–28; emotional well-being, scored 0–24), to the score obtained on the LYM subscale (15 items; responses to each item range from 0, Not at all to 4, Very much). Total score ranges from 0 to 168. Higher scores indicated a better participant-reported outcome/quality of life over the past week when responding to the items."|Up to 6 years (assessed at start, mid and end of induction [induction: 18.7 months], at each infusion during maintenance [maintenance phase: 67.8 months], and at disease progression [maximum up to 6 years])|All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. n=number of evaluable questionnaires for each category.||score on scale|Participants|Standard Deviation|Mean
641217|NCT02316613|Secondary|Percentage of Participants With Discontinuations and Modifications of MabThera During Maintenance Phase||Maintenance phase : 67.8 months|All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed= participants who received at least one MabThera infusion over the maintenance therapy period. n=number of evaluable participants for each category.||percentage of participants|||Number
641218|NCT02316613|Secondary|MabThera Regimen: Time Between Cycles||Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)|All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed= participants who received at least one cycle of MabThera and available with valid data.||days||Standard Deviation|Mean
641219|NCT02316613|Secondary|MabThera Regimen: Number of Cycles of MabThera||Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)|All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed= participants who received at least one cycle of MabThera and available with valid data for this outcome.||number of cycles||Standard Deviation|Mean
641220|NCT02316613|Secondary|MabThera Regimen: Infusion Duration||Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)|All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed= participants who received at least one cycle of MabThera and available with valid data.||minutes (mn)||Standard Deviation|Mean
641221|NCT02316613|Secondary|MabThera Regimen: Dose of MabThera|All participants who received MabThera treatment before the first disease progression were reported.|Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)|All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed= participants who received at least one cycle of MabThera and available with valid data for this outcome.||milligram (mg)||Standard Deviation|Mean
641222|NCT02316613|Primary|Number of Participants With Therapeutic Management After the First Study Disease Progression|After the first disease progression the participants received chemotherapy, immunotherapy, radio immunotherapy, stem cell transplantation, or radiation therapy for therapeutic management of the refractory/relapsed follicular non-Hodgkin's lymphoma. One participant could receive more than one type of treatment after the first study disease progression.|Up to 6 years|Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed= participants with at least one disease progression over the study period.||participants|||Number
641233|NCT02316613|Secondary|Time to Next Treatment|Time to next treatment was calculated from the date of the end of first induction treatment administration over the study to the date of the start of next treatment after disease progression.|Up to 6 years|Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included.||months||95% Confidence Interval|Median
641223|NCT02316613|Primary|Percentage of Participants With Modalities of the Therapeutic Decision at First Study Disease Progression|The therapeutic management of participants was decided by either “pluri-disciplinary consultation meeting,” “Only the physician in charge of the participant,” “Discussion between physicians,” or “Punctual consultation of an external physician.” Percentage of participants with each of these modalities of therapeutic decision was reported.|Up to 6 years|Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed= participants with at least one disease progression over the study period.||percentage of participants|||Number
641224|NCT02316613|Primary|Percentage of Participants With Injection Prophylaxis Treatment|Participants received anti-pneumocystosis agents, antiviral agents, or immunoglobulins as infection prophylaxis. One participant could receive more than one infection prophylaxis treatment.|Maintenance/observation Phase: 67.8 months|Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number participants analyzed= all participants having had maintenance/observation period before the first study disease progression and received infection prophylaxis treatment.||percentage of participants|||Number
641225|NCT02316613|Primary|Percentage of Participants With Prescription of Injection Prophylaxis|Participants was prescribed with either of the following infection prophylaxis treatment: anti-pneumocystosis agents, antiviral agents, or immunoglobulins.|Maintenance/observation Phase: 67.8 months|Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed=all participants having had maintenance/observation period before the first study disease progression.||percentage of participants|||Number
641226|NCT02316613|Primary|Duration of MabThera Maintenance Therapy When Associated With Observation|Duration of MabThera maintenance therapy was calculated from the end of induction period to the day before the first disease progression over the study (or to the date of last participant information if no disease progression until the end of the participant follow-up). Disease progression was based on the followings: Eastern Cooperative Oncology Group performance status; presence of B symptoms (fever 38°C in absence of infection for more than 8 days, night sweats, weight loss exceeding 10% in 6 months); evaluation of tumor mass (Groupe d'Etudes des Lymphomes Folliculaires criteria); number of nodal sites; number and location of extranodal sites; Ann-Arbor stage (I to IV); any histological documentation: type of biopsy (nodal, extranodal, bone marrow); histological type (progression of follicular non-Hodgkin's lymphomas or transformation); latest available hemoglobin, neutrophils, normal or leukemic lymphocytes, platelets, lactate dehydrogenase, and total gamma globulins level.|Maintenance/observation Phase: 67.8 months|Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed = those who received at least one infusion of MabThera and completed maintenance therapy with MabThera when associated with observation period.||months||Full Range|Median
641227|NCT02316613|Primary|Percentage of Participants With MabThera Maintenance Therapy and at Least One Observation Phase|After study induction period (three visits) participants entered into either of two periods: 1. period of maintenance with MabThera followed by observation or 2. period of observation/maintenance without MabThera, followed by maintenance with MabThera.|Maintenance/observation Phase: 67.8 months|Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed = those who received at least one MabThera infusion over the maintenance therapy period.||percentage of participants|||Number
641228|NCT02316613|Primary|Percentage of Participants With MabThera as Maintenance Therapy|During the maintenance period participants received four weekly infusion of MabThera.|Maintenance/observation Phase: 67.8 months|Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed= those who entered in maintenance/observation after the first induction and before the first disease progression over the study.||percentage of participants||95% Confidence Interval|Number
641229|NCT02316613|Primary|Percentage of Participants With Chemotherapies Prescribed Over the First Study Induction Phase|Over the first study induction phase, participants received the following chemotherapy: regimen including fludarabine; regimen including aracytine - platinum salts; cyclophosphamide/hydroxydaunorubicin/oncovin/prednisone (CHOP-like); cyclophosphamide/vincristine/prednisone (CVP); regimen including ifosfamide - etoposide; and other chemotherapy. One participant could receive more than one type of chemotherapy over the first treatment induction period.|Induction Phase: 18.7 months|Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included.||percentage of participants|||Number
641230|NCT02316613|Primary|Percentage of Participants With Treatments Prescribed Over the First Study Induction Phase|Over the first treatment induction period, participants received following therapies for the treatment of refractory/relapsed follicular non-Hodgkin’s lymphoma: chemotherapy combined with MabThera, chemotherapy alone, MabThera monotherapy, and stem cell transplantation, radio-immunotherapy, or radiation therapy combined with any other treatment. Study induction treatment phase consists total of three visits (one before the first cycle, one halfway through therapy and one after the last cycle to evaluate response). Induction treatment duration ranged between <3 months to >6 months. Each participants may received more than one therapy.|Induction Phase: 18.7 months|Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included.||percentage of participants|||Number
641231|NCT02316613|Secondary|Number of Participants Who Used MabThera||Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)|All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included.||participants|||Number
641232|NCT02316613|Secondary|Overall Survival (OS)|The overall survival was defined as the time from the date of first induction treatment administration over the study to the date of participants' death or early study withdrawal. OS was calculated using Kaplan-Meier method.|Up to 6 years|Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included.||months||95% Confidence Interval|Median
641234|NCT02316613|Secondary|Progression Free Survival (PFS)|The PFS was defined as the time from the date of first induction treatment over the study (first treatment administration of first cycle) to the date of first disease progression or participants death or date of lymphoma transformation diagnosis.|Up to 6 years|Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included.||months||95% Confidence Interval|Median
641235|NCT02316613|Secondary|Percentage of Participants With Disease Characteristics at First Study Disease Progression|Disease characteristics included (tumor burden, measured from whole body computed tomography (CT) scan. Groupe d'Etudes des Lymphomes Folliculaires (GELF) criteria defined as parameters to initiate treatment in participants with untreated follicular lymphoma, grade 1,2,or 3A; having just one of the criteria justified treatment: 1. involvement of >=3 nodal sites, each with diameter of >=3 centimeter(cm); 2. any nodal/extranodal tumor mass with diameter of >=7cm; 3. B symptoms (temperature >=38 degrees celsius or night sweats or weight loss >10% over past 6 months); 4. splenomegaly; 5. pleural effusion/peritoneal ascites; 6. cytopenia (leukocytes <1×10^9 and/or platelets <100×10^9/L. One participant could present with more than 1 GELF criterion. Ann Arbor staging was used as staging system for lymphomas (Stage I to IV); stage depended upon the place where malignant tissue was located (through biopsy, CT scan, or positron emission tomography) and on systemic symptoms due to lymphoma).|Up to 6 years|Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed= participants with at least one disease progression over the study period. n=number of evaluable participant for each disease characteristics.||percentage of participants|||Number
641236|NCT02316613|Secondary|Percentage of Participants With Number of Disease Progressions|Participants with at least one disease progression after the first study induction period were reported.|Up to 6 years|Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed= those participants who entered in maintenance/observation after the first induction and before the first disease progression over the study.||percentage of participants|||Number
641237|NCT02316613|Secondary|Percentage of Participants With Last Induction Treatment Response|Last Induction treatment response: the last response assessment over the first study induction treatment (complete response [CR]: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CR unconfirmed: CR along with regression in lymph node mass by more than [>]75% in the sum of the products of greatest diameters [SPD]; Partial Response [PR]: greater than or equal to [>=] 50% decrease in SPD of 6 largest dominant nodes or nodal masses; Progression was 1 of the following: 1) lymphadenopathy; 2) a >=50% increase in previously noted or new appearance of hepato/splenomegaly; 3) >=50% increase in blood lymphocyte count with at least 5000 B lymphocytes/μL; 4) transformation to Richter’s syndrome; or 5) occurrence of cytopenia; Stable disease [SD]: absence of necessary criteria to achieve CR or PR, but no advancement to progression) was described at the end of first study induction.|Induction Phase: 18.7 months|Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed (N)=number of participants evaluable for this outcome measure.||percentage of participants|||Number
641238|NCT02316613|Primary|Percentage of Participants With Modalities of the Therapeutic Decision Before First Study Induction Treatment Phase|At study inclusion, the therapeutic management of participants was decided by either “pluri-disciplinary consultation meeting,” “Only the physician in charge of the participant,” “Discussion between physicians,” or “Punctual consultation of an external physician.” Percentage of participants with each of these modalities of therapeutic decision was reported.|Baseline|Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed = participants who were evaluable for this outcome measure.||percentage of participants|||Number
641239|NCT02316470|Secondary|Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group|percentage of participants with solicited (sol.) local and systemic AEs within 7 days after each and after any vaccination (vacc.), collected via a subject diary with predefined terms, stratified by age group (subjects 50 - < 65 years and 65 years and older)|within 7 Days after each vaccination|Safety Population = study participants with at least one study vaccination||percentage of participants||95% Confidence Interval|Number
641240|NCT02316470|Secondary|Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group|percentage of study participants with at least one SAE, related SAE, unsolicited (unsol.) AE (incl. clinically significant laboratory parameter changes) and related unsolicited AE, starting up to Day 56 and Day 210, stratified by age group (subjects 50 - < 65 years and 65 years and older (65+))|Day 56 and Day 210|Safety Population = study participants with at least one study vaccination||percentage of participants||95% Confidence Interval|Number
641241|NCT02316470|Secondary|Rates of Study Participants With at Least One Solicited Local and Systemic AE|percentage of study participants with solicited local and systemic AE within 7 days after each and after any vaccination, collected via a subject diary with predefined terms|within 7 Days after each vaccination|Safety Population = study participants with at least one study vaccination||percentage of participants||95% Confidence Interval|Number
641242|NCT02316470|Secondary|Rate of Study Participants With at Least One Related Unsolicited AE|percentage of study participants with at least one related unsolicited AE starting up to Day 56 and Day 210 (incl. clinically significant laboratory parameter changes)|Day 56 and Day 210|Safety Population = study participants with at least one study vaccination||percentage of participants||95% Confidence Interval|Number
641243|NCT02316470|Secondary|Rate of Study Participants With at Least One Unsolicited AEs (Adverse Event)|percentage of study participants with at least one unsolicited AE starting up to Day 56 and Day 210 (incl. clinically significant laboratory parameter changes)|Day 56 and Day 210|Safety Population = study participants with at least one study vaccination||percentage of participants||95% Confidence Interval|Number
641244|NCT02316470|Secondary|Rate of Study Participants With at Least One Related SAE|percentage of study participants with at least one related SAE starting up to Day 56 and up to Day 210|Day 56 and Day 210|Safety Population = study participants with at least one study vaccination||percentage of participants||95% Confidence Interval|Number
641246|NCT02316470|Secondary|Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group|"Responder Rate for neutralizing antibodies against Toxin A (RR Tox A), against Toxin B (RR Tox B) and against both Toxin A and Toxin B (RR Tox A and B) on Days 35, 56, 120* and 210, stratified by age group (subjects 50 - < 65 years and 65 years and older)
* TNA in sera from Day 120 were to be measured only if meaningful in view of the Day 56 and Day 210 results; in fact Day 120 TNA was not measured."|Days 35, 56, 120 and 210|PP210 = per protocol population defined as subjects without major protocol deviation up to Day 210||percentage of participants||95% Confidence Interval|Number
641247|NCT02316470|Secondary|Responder Rate (RR) for Toxin B Neutralizing Antibodies|"Responder Rate (RR) (defined as percentage of subjects achieving a ≥4-fold increase in neutralizing antibody titer from Day 0) for neutralizing antibodies against Toxin B on Days 35, 56, 120* and 210
* TNA in sera from Day 120 were to be measured only if meaningful in view of the Day 56 and Day 210 results; in fact Day 120 TNA was not measured."|Days 35, 56, 120 and 210|PP210 = per protocol population defined as subjects without major protocol deviation up to Day 210||percentage of participants||95% Confidence Interval|Number
641248|NCT02316470|Secondary|Responder Rate (RR) for Toxin A Neutralizing Antibodies|"Responder Rate (RR) (defined as percentage of subjects achieving a ≥4-fold increase in neutralizing antibody titer from Day 0) for neutralizing antibodies against Toxin A on Days 35, 56, 120* and 210
* TNA in sera from Day 120 were to be measured only if meaningful in view of the Day 56 and Day 210 results; in fact Day 120 TNA was not measured."|Days 35, 56, 120 and 210|PP210 = per protocol population defined as subjects without major protocol deviation up to Day 210||percentage of participants||95% Confidence Interval|Number
641249|NCT02316470|Secondary|Responder Rate (RR) for Neutralizing Antibodies Against Both Toxin A and Toxin B|"Responder Rate (RR) (defined as percentage of subjects achieving a ≥4-fold increase in neutralizing antibody titer from Day 0) for neutralizing antibodies against both Toxin A and Toxin B on Days 35, 56, 120* and 210
* TNA in sera from Day 120 were to be measured only if meaningful in view of the Day 56 and Day 210 results; in fact Day 120 TNA was not measured."|Days 35, 56, 120, 210|PP210 = per protocol population defined as subjects without major protocol deviation up to Day 210||percentage of participants||95% Confidence Interval|Number
641250|NCT02316470|Secondary|GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group|"GMTs for Toxin A neutralizing antibodies and for Toxin B neutralizing antibodies as determined by Toxin Neutralization Assay on Days 0, 35, 56, 120* and 210, stratified by age group (subjects 50 - < 65 years and 65 years and older)
* TNA in sera from Day 120 were to be measured only if meaningful in view of the Day 56 and Day 210 results; in fact Day 120 TNA was not measured."|Days 0, 35, 56, 120 and 210|PP210 = per protocol population defined as subjects without major protocol deviation up to Day 210||Titer||95% Confidence Interval|Geometric Mean
641251|NCT02316470|Secondary|GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group|GMT for IgG against Toxin A and against Toxin B on Days 0, 14, 28, 35, 56, 120 and 210, stratified by age group (subjects 50 - < 65 years and 65 years and older)|Days 0, 14, 28, 35, 56, 120, 210|PP210 = per protocol population defined as subjects without major protocol deviation up to Day 210||EU/ml||95% Confidence Interval|Geometric Mean
641252|NCT02316470|Secondary|SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group|Seroconversion Rate (SCR) for IgG against Toxin A, against Toxin B and against both Toxin A and Toxin B on Days 14, 28, 35, 56, 120 and 210, stratified by age group (subjects 50 - < 65 years and 65 years and older)|Days 14, 28, 35, 56, 120 and 210|PP210 = per protocol population defined as subjects without major protocol deviation up to Day 210||percentage of participants||95% Confidence Interval|Number
641253|NCT02316470|Secondary|GMT for Toxin B Neutralizing Antibodies|"GMT for Toxin B neutralizing antibodies (TNA) as determined by Toxin Neutralization Assay on Days 0, 35, 56, 120* and 210
* TNA in sera from Day 120 were to be measured only if meaningful in view of the Day 56 and Day 210 results; in fact Day 120 TNA was not measured."|Days 0, 35, 56, 120 and 210|PP210 = per protocol population defined as subjects without major protocol deviation up to Day 210||Titer||95% Confidence Interval|Geometric Mean
641254|NCT02316470|Secondary|GMT for Toxin A Neutralizing Antibodies|"GMT for Toxin A neutralizing antibodies (TNA) as determined by Toxin Neutralization Assay on Days 0, 35, 56, 120* and 210
* TNA in sera from Day 120 were to be measured only if meaningful in view of the Day 56 and Day 210 results; in fact Day 120 TNA was not measured."|Days 0, 35, 56, 120 and 210|PP210 = per protocol population defined as subjects without major protocol deviation up to Day 210||Titer||95% Confidence Interval|Geometric Mean
641255|NCT02316470|Secondary|Geometric Mean Titer (GMT) for IgG Against Toxin B|Geometric Mean Titer (GMT) for IgG against Toxin B as determined by ELISA on Days 0, 14, 28, 35, 56 (primary endpoint time point), 120 and 210;|Days 0, 14, 28, 35, 56, 120 and 210|PP210 = per protocol population defined as subjects without major protocol deviation up to Day 210||EU/ml||95% Confidence Interval|Geometric Mean
641256|NCT02316470|Secondary|Geometric Mean Titer (GMT) for IgG Against Toxin A|Geometric Mean Titer (GMT) for IgG against Toxin A as determined by ELISA on Days 0, 14, 28, 35, 56 (primary endpoint time point), 120 and 210;|Days 0, 14, 28, 35, 56, 120 and 210|PP210 = per protocol population defined as subjects without major protocol deviation up to Day 210||EU/ml||95% Confidence Interval|Geometric Mean
641257|NCT02316470|Secondary|Seroconversion Rate (SCR) for IgG Against Toxin B|Seroconversion Rate (SCR), defined as percentage of subjects achieving a ≥4-fold increase in antibody titer from Day 0, for IgG against Toxin B;|Days 14, 28, 35, 56, 120 and 210|per-protocol population,i.e., subjects who received at least one study vaccination without any major protocol deviation up to Day 210||percentage of participants||95% Confidence Interval|Number
641258|NCT02316470|Secondary|Seroconversion Rate (SCR) for IgG Against Toxin A|Seroconversion Rate (SCR), defined as percentage of subjects achieving a ≥4-fold increase in antibody titer from Day 0, for IgG against Toxin A;|14, 28, 35, 56, 120 and 210|per-protocol population,i.e., subjects who received at least one study vaccination without any major protocol deviation up to Day 210||percentage of participants||95% Confidence Interval|Number
641259|NCT02316470|Secondary|SCR for IgG (Immunoglobulin G) Against Both Toxin A and Toxin B|Seroconversion Rate (SCR), defined as percentage of subjects achieving a ≥4-fold increase in antibody titer from Day 0, for IgG against both Toxin A and Toxin B on Day 14, 28, 35, 120 and 210;|Days 14, 28, 35, 120 and 210|per-protocol population,i.e., subjects who received at least one study vaccination without any major protocol deviation up to Day 210||percentage of participants||95% Confidence Interval|Number
641260|NCT02316470|Primary|Seroconversion Rate (SCR) on Day 56|Seroconversion Rate (SCR), defined as percentage of subjects achieving a ≥4-fold increase in antibody titer from Day 0, for IgG against both Toxin A and Toxin B on Day 56;|Day 56|per-protocol population,i.e., subjects who received at least one study vaccination without any major protocol deviation up to Day 210||percentage of study participants||95% Confidence Interval|Number
641261|NCT02316366|Secondary|Global Comfort|Upon disposition patients were asked to complete a survey which assessed their global comfort during the ED stay|4 hours||||||
641262|NCT02316366|Secondary|Amount of Narcotic Administered|The amount of opioid analgesic administered in the ED prior to disposition was recorded for each patient|4 hours|||mg/kg||95% Confidence Interval|Mean
641263|NCT02316366|Secondary|Time to Disposition|The amount of time spent in the ED was recorded for each patient|4 hours|||minutes||95% Confidence Interval|Mean
641264|NCT02316366|Secondary|Pain Score|During the ED stay, patient's pain scores on the Wong-Baker FACES scale was recorded at 30 minute intervals until disposition decided.|4 hours||||||
641265|NCT02316366|Primary|Rate of Hospital Admission|After being treated for pain in the Emergency Department, the disposition of the patient (whether admitted to the hospital for further care or discharge to home) was recorded.|4 hours|||percentage of participants||95% Confidence Interval|Number
641266|NCT02315989|Secondary|Percentage of Each Target Lesion Evaluation Types.(1)Complete Response(2)Partial Response,(3)Progressive Disease,(4)Stable Disease,(5) Inevaluable|Response Evaluation Criteria In Solid Tumors:(1)complete Response(CR),Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm (2)Partial Response(PR), At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. (3)Progressive Disease(PD), At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (4)Stable Disease(SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. (5) Inevaluable (NE), Inevaluable for response: specify reasons (for example: early death, malignant disease; toxicity; tumor assessments not repeated/incomplete; other (specify).|Average 100 days after treatment.|||percentage of participants|||Number
641267|NCT02315989|Secondary|Percentage of System Errors|During treatment, the frequency of operation of the system error will be recorded and analyzed to see if the system can run smoothly.|Average 100 days after treatment.|||percentage of system errors|||Number
641268|NCT02315989|Primary|Rate and Severity of Adverse Reactions|After enrollment, each patient has to receive physical examination, laboratory tests, and image studies as baseline. During the course of radiotherapy, patients will have weekly evaluations in physicals and laboratory tests. Image studies are optional during treatment. In the follow-up periods, monthly exams, including regular physicals, markers in serum and urine and image studies to evaluation treatment responses, will be scheduled till 90 days after the end of treatment.|Average 90 days after treatment.|||participants|||Number
641269|NCT02315352|Secondary|Number of Subjects With Discomfort or Observations Relating to Acceptance of the Study Medication||2-5 minutes|The Safety Set (SAF) included all enrolled subjects who received at least 1 dose of any study drug.||Subjects|||Number
641270|NCT02315352|Secondary|Number of Subjects With Mouth Feeling and Taste Description Evaluation|Mouth feeling was described in terms of “sweet”, “bitter”, “sticky” or “smooth” as per the experience of the subject with the trial medication.|2-5 minutes (After the IMP has been spat out)|The data for this outcome measure could not be evaluated as data were not collected according to protocol.|||||
641271|NCT02315352|Secondary|Overall Palatability VAS Score at 2-5 Minutes|Overall palatability was assessed on a 0 to 100 unit VAS scale, where higher scores indicate better palatability.|2-5 minutes (After the IMP has been spat out)|The Safety Set (SAF) included all enrolled subjects who received at least 1 dose of any study drug.||units on a scale||Standard Deviation|Mean
641272|NCT02315352|Primary|Overall Palatability Visual Analogue Scale (VAS) Score at 0 Minute (Right After the Spit-out of the Investigational Medicinal Product [IMP])|Overall palatability was assessed on a 0 to 100 unit VAS scale, where higher scores indicate better palatability.|0 minute (Right After the Spit-out of the IMP)|The Safety Set (SAF) included all enrolled subjects who received at least 1 dose of any study drug.||units on a scale||Standard Deviation|Mean
641273|NCT02314689|Secondary|Nitric Oxide|Unposted|2 years||12/2018||||
641274|NCT02314689|Primary|Number of Participants With Grade 2 or Higher Adverse Event According to NCI Criteria||2 years|||participants|||Number
641275|NCT02314637|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 52||Baseline and Week 52|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after the treatment of study drug. Analysis based on last observation carried forward, where the last postbaseline observed value was carried forward and used for Week 52 where data was missing.||mg/dL||Standard Deviation|Mean
641276|NCT02314637|Secondary|Change From Baseline in HbA1c at Week 52||Baseline and Week 52|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after the treatment of study drug. Analysis based on last observation carried forward, where the last postbaseline observed value was carried forward and used for Week 52 where data was missing.||percent||Standard Deviation|Mean
641277|NCT02314637|Primary|Number of Participants With Adverse Events|Treatment-emergent adverse events (TEAE) were defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after receiving the last dose of study drug.|52 weeks|Safety set, consisting of all patients, who received at least one dose of study drug and who had at least one safety data after the treatment of study drug.||participants|||Number
641278|NCT02314546|Secondary|Verbal Complaints|Recorded by the administering RN at one minute post-administration|1 minute post-administration|||participants|||Number
641279|NCT02314546|Secondary|Verbal Complaint|Recorded by the administering RN at the time of administration.|At time of administration|||participants|||Number
641280|NCT02314546|Secondary|RN Observed Behavioral Distress Score|Measured by the administering RN using a Visual Analog Scale. The scale ranges from a minimum score of 0 (no distress at all) to a maximum of 10 (most distress possible).|1 minute post-administration|||units on a scale||Standard Deviation|Mean
641286|NCT02314520|Secondary|Number of Patients With Complications Related to Insertion|Any complication of insertion including technical failure|From the time of insertion until first confirmatory chest X-ray|||Participants|||Count of Participants
641287|NCT02314520|Secondary|Number of Participants With Deep Venous Thrombosis||up to 10 weeks|||Participants|||Count of Participants
641288|NCT02314520|Primary|Participants With Complications With Central Access Including Insertion|Aggregation of all complications associated with central access including insertion|up to 10 weeks|||Participants|||Count of Participants
641289|NCT02314260|Secondary|Cut Off Value for Bishop Score|the value at which there a high sensitivity and specificity to predict failed labour induction|5 months|sensitivity of 83% & specificity was 73% to failed induction||probability|||Number
641290|NCT02314260|Secondary|Cut Off Value for The Modified Bishop Score|the value at which there a high sensitivity and specificity to predict failed labour induction|5 months|sensitivity of 83% and a specificity of 87% for failed induction.||probability|||Number
641291|NCT02314260|Secondary|Area Under Curve for The Bishop Score|to predict failed induction and comparing it to the area under curve for modified bishop score to find out which test is more accurate in predicting caesarean section, The positive actual state is failed induction and performing Caesarean Section. The positive actual state is failed induction, the true positive rate (Sensitivity) is plotted in function of the false positive rate (100-Specificity), So as the numbers approaches 1, induction fails, the Y-axis of the curve is sensitivity and the x- axis is (1-specificity).|5 months|The positive actual state is failed induction and performing Caesarean Section, So as the numbers approaches 1, induction of labour fails, the Y-axis of the curve is (sensitivity) and the x- axis is (1-specificity).||probability||95% Confidence Interval|Number
641292|NCT02314260|Primary|Area Under Receiver Operating Characteristic Curve (ROC) for Modified Bishop Score|to predict failed induction and comparing it to the area under curve for bishop score to find out which test is more accurate in predicting caesarean section, The positive actual state is failed induction and performing Caesarean Section.The positive actual state is failed induction, the true positive rate (Sensitivity) is plotted in function of the false positive rate (100-Specificity). So as the numbers approaches 1, induction fails, the Y-axis of the curve is sensitivity and the x- axis is (1-specificity).|5 months|the area under the modified bishop score was 0.916 (95% [confidence interval ] 0.85–0.97). The positive actual state is failed induction and performing Caesarean Section, So as the numbers approaches 1, induction fails, the Y-axis of the curve is sensitivity and the x- axis is (1-specificity).||probability||95% Confidence Interval|Number
641293|NCT02314104|Secondary|Total Narcotic Usage in Morphine Equivalents||up to twenty-four hours postoperatively|||mg||Standard Deviation|Mean
641294|NCT02314104|Secondary|Time Until First Request for Pain Medication||up to twenty-four hours postoperatively|||minutes||Inter-Quartile Range|Median
641295|NCT02314104|Primary|Postoperative Pain on a Visual Analogue Pain Scale at Twenty-four Hours Postoperatively|A Visual Analogue Scale was used. The scale range was 0 to 10 in increments of one. 0 was no pain and 10 was worst pain possible.|twenty-four hours postoperatively|Arm 1: one subject discharged prior to obtaining 24 hour pain score Arm 2: one subject discharged prior to obtaining 24 hour pain score Arm 3: four subjects discharged prior to obtaining 24 hour pain score||units on a scale||Standard Deviation|Mean
641296|NCT02314104|Primary|Postoperative Pain on a Visual Analogue Pain Scale at Six Hours Postoperatively|A Visual Analogue Scale was used. The scale range was 0 to 10 in increments of one. 0 was no pain and 10 was worst pain possible.|six hours postoperatively|Arm 2: 6 hour pain score not obtained on one subject Arm 3: 6 hour pain score not obtained on one subject||units on a scale||Standard Deviation|Mean
641297|NCT02314104|Primary|Postoperative Pain on a Visual Analogue Pain Scale at One Hour Postoperatively|A Visual Analogue Scale was used. The scale range was 0 to 10 in increments of one. 0 was no pain and 10 was worst pain possible.|one hour postoperatively|||units on a scale||Standard Deviation|Mean
641298|NCT02313766|Secondary|Discomfort of the Preoxygenation Phase Self Reported by the Patient|discomfort of the preoxygenation phase evaluated on a visual analogue scale (0 no discomfort - 100 maximal discomfort) just before PACU leaving|Before PACU leaving|||millimeters||Inter-Quartile Range|Median
641299|NCT02313766|Secondary|Time Until SpO2=93%|time until SpO2=93% after endotracheal tube placement has been confirmed|up to 10 min|||seconds||Inter-Quartile Range|Median
641300|NCT02313766|Primary|Time for Preoxygenationfrom Face Mask Positioning to FEO2=90%|Time measured form face mask positioning until FEO2 reached 90% on the gas monitor|up to 5 min|||seconds||Inter-Quartile Range|Median
641301|NCT02313558|Primary|Gingivitis Assessment After 12 Weeks of Dentifrice Use|"After 12 weeks gingivitis was scored according to the Löe-Silness Gingival Index. Each tooth was scored on facial and lingual surfaces. Third molars and those teeth with cervical restorations or prosthetic crowns were excluded from the scoring procedure. The gingiva adjacent to each tooth surface was scored as follows: 0 = Absence of inflammation; 1 = Mild inflammation: slight change in color and little change in texture; 2 = Moderate inflammation: moderate glazing, redness, edema, hypertrophy. Tendency to bleed upon probing; 3 = Severe inflammation: marked redness and hypertrophy. Tendency for spontaneous bleeding.
Whole-mouth mean scores were obtained by averaging the values obtained over all scoreable surfaces in the mouth."|12 weeks after dentifrice use|||units on a scale||Standard Deviation|Mean
641302|NCT02313558|Primary|Plaque Assessment After 12 Weeks of Dentifrice Use|"After 12 weeks supra-gingival plaque on the facial and lingual surfaces of each tooth was scored according to the Turesky modification of the Quigley-Hein Plaque Index. Third molars and those teeth with cervical restorations or prosthetic crowns were excluded from the scoring procedure. Plaque was disclosed and scored on each tooth surface according to the following criteria: 0 = No plaque; 1 = Separate flecks of plaque at the cervical margin of the tooth; 2 = A thin, continuous band of plaque (up to 1 mm) at the cervical margin of the tooth; 3 = A band of plaque wider than 1 mm, but covering less than 1/3 of the side of the crown of the tooth; 4 = Plaque covering at least 1/3, but less than 2/3 of the side of the crown of the tooth; 5 = Plaque covering 2/3 or more of the side of the crown of the tooth.
Whole-mouth mean scores were obtained by averaging the values obtained over all scoreable surfaces in the mouth."|12 weeks after dentifrice use|||units on a scale||Standard Deviation|Mean
641361|NCT02311907|Secondary|Percentage of Patients Undergoing Dose Reductions Secondary to PCI PN|Proportion of patients requiring chemotherapy dose reductions secondary to TAXOL/CBDCA induced peripheral neuropathy between GSH and placebo arms.|Up to 1 year|||percentage of participants|||Number
641303|NCT02313558|Primary|Gingivitis Assessment After 6 Weeks of Dentifrice Use|After 6 weeks gingivitis was scored according to the Löe-Silness Gingival Index. Each tooth was scored on facial and lingual surfaces. Third molars and those teeth with cervical restorations or prosthetic crowns were excluded from the scoring procedure. The gingiva adjacent to each tooth surface was scored as follows: 0 = Absence of inflammation; 1 = Mild inflammation: slight change in color and little change in texture; 2 = Moderate inflammation: moderate glazing, redness, edema, hypertrophy. Tendency to bleed upon probing; 3 = Severe inflammation: marked redness and hypertrophy. Tendency for spontaneous bleeding.|6 weeks after dentifrice use|||units on a scale||Standard Deviation|Mean
641304|NCT02313558|Primary|Plaque Assessment After 6 Weeks of Dentifrice Use|"After 6 weeks supra-gingival plaque on the facial and lingual surfaces of each tooth was scored according to the Turesky modification of the Quigley-Hein Plaque Index. Third molars and those teeth with cervical restorations or prosthetic crowns were excluded from the scoring procedure. Plaque was disclosed and scored on each tooth surface according to the following criteria: 0 = No plaque; 1 = Separate flecks of plaque at the cervical margin of the tooth; 2 = A thin, continuous band of plaque (up to 1 mm) at the cervical margin of the tooth; 3 = A band of plaque wider than 1 mm, but covering less than 1/3 of the side of the crown of the tooth; 4 = Plaque covering at least 1/3, but less than 2/3 of the side of the crown of the tooth; 5 = Plaque covering 2/3 or more of the side of the crown of the tooth.
Whole-mouth mean scores were obtained by averaging the values obtained over all scoreable surfaces in the mouth."|6 weeks after dentifrice use|||units on a scale||Standard Deviation|Mean
641305|NCT02313233|Primary|Quality of Life (QoL) Index Between V1 and V6 for the Subjects Taking 0.4 mg Harnalidge|The Quality of Life (QoL) is a single question with scores of 0~6 point and corresponding to the assessment index ranging from delighted to terrible.|56 days|All these twenty-two subjects included in this statistical result have been received 0.4 mg Harnalidge for BPH treatment.||units on a scale||Standard Deviation|Mean
641306|NCT02313233|Primary|International Prostate Symptom Score (IPSS) Between V1 and V6 in the Same Medication for More Than 12 Months|It's 7- item urinary symptom severity scale. The answers are assigned points from 0 to 5, indicating increasing severity. The total score can therefore range from 0 to 35 points.|56 days|All these five subjects in this statistical result have been treated BPH with 0.4 mg of Harnalidge for more than 12 months.||units on a scale||Standard Deviation|Mean
641307|NCT02313233|Primary|Quality- Of- Life Index (QoL)|The QoL index is a single question with scores of 0~6 point and corresponding to the assessment index ranging from delighted to terrible.|56 days|For all subjects' medical histories in this study, there are one subject receiving Harnalidge 0.1 mg once daily (QD), 5 subjects receiving Hatnalidge 0.2 mg QD, 22 subjects receiving Harnalidge 0.4 mg QD and eight subjects receiving Doxaben XL 4 mg QD for BPH treatment||units on a scale||Standard Deviation|Mean
641308|NCT02313233|Secondary|Prostate-specific Antigen (PSA) Level|Serum PSA test measures the amount of prostate- specific antigen in the blood. As a man's prostate enlarges with age, the amount of PSA in the blood normally increases.|56 days|For all subjects' medical histories in this study, there are one subject receiving Harnalidge 0.1 mg once daily (QD), five subjects receiving Harnalidge 0.2 mg QD, 22 subjects receiving 0.4 mg QD and eight subjects receiving Doxaben 4 mg or Doxaben XL 4 mg QD for BPH treatment.||ng/ml||Standard Deviation|Mean
641309|NCT02313233|Secondary|Prostate Volume|It's related to progression of benign prostatic hyperplasia (BPH).|56 days|For all subjects' medical histories in this study, there are one subject receiving Harnalidge 0.1 mg once daily (QD), five subjects receiving Harnalidge 0.2 mg QD, 22 subjects receiving Harnalidge 0.4 mg QD and eight subjects receiving Doxaben 4 mg or Doxaben XL 4 mg QD for BPH treatment.||cm^3||Standard Deviation|Mean
641310|NCT02313233|Secondary|Postvoid Residual Volume (PVR)|The PVR urine test measures the amount of urine left in the bladder after urination.|56 days|For all subjects' medical histories in this study, there are one subject receiving Harnalidge 0.1 mg once daily (QD), five subjects receiving Harnalidge 0.2 mg QD, 22 subjects receivingHarnalidge 0.4 mg QD and eight subjects receiving Doxaben 4 mg or Doxaben XL 4 mg QD for BPH treatment.||ml||Standard Deviation|Mean
641311|NCT02313233|Secondary|Maximum Flow Rate (Qmax)|It's used to determine the degree of urinary difficulty.|56 days|For all subjects' medical histories in this study, there are one subject receiving Harnalidge 0.1 mg once daily (QD), 5 subjects receiving Harnalidge 0.2 mg QD, 22 subjects receiving Harnalidge 0.4 mg QD and eight subjects receiving Doxaben XL 4 mg QD for BPH treatment.||ml/ sec||Standard Deviation|Mean
641312|NCT02313233|Primary|International Prostate Symptom Score (IPSS)|It's 7- item urinary symptom severity scale. The answers are assigned points from 0 to 5, indicating increasing severity. The total score can therefore range from 0 to 35 points.|56 days|For all subjects' medical histories in this study, there are one subject receiving Hatnalidge 0.1 mg once daily (QD), five subjects receiving Harnalidge 0.2 mg QD, 22 subjects receiving Harnalidge 0.4 mg QD and eight subjects receiving Doxaben 4 mg or Doxaben XL 4 mg QD for BPH treatment.||units on a scale||Standard Deviation|Mean
641313|NCT02313155|Secondary|GMT in SRH Antibody Titer (Cell Derived Antigen)|GMT in SRH antibody titer (vero antigen, live-vero antigen, and madin-darby canine kidney [MDCK] antigen) for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain) was computed along with 95% CI.|Day 22 (21 days after vaccination)|Full analysis set was defined as participants who were randomized and received vaccination with the study drug.||titer||95% Confidence Interval|Geometric Mean
641314|NCT02313155|Secondary|GMFI in SRH Antibody Titer (Cell Derived Antigen) From Pre-vaccination to 21 Days After Vaccination|GMFI in SRH antibody titer (vero antigen, live-vero antigen, and madin-darby canine kidney [MDCK] antigen) as compared to pre-vaccination was evaluated for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain). Geometric mean and CI were calculated for GMFIs.|Pre-vaccination, 21 Days After vaccination (Day 22)|Full analysis set was defined as participants who were randomized and received vaccination with the study drug.||fold increase||95% Confidence Interval|Geometric Mean
641315|NCT02313155|Secondary|Percentage of Participants With Seroconversion in SRH Antibody Titer (Cell Derived Antigen)|Seroconversion rate as measured by the SRH antibody titer (vero antigen, live-vero antigen, and madin-darby canine kidney [MDCK] antigen) was defined as percentage of participants achieving a minimal 50% increase from the baseline SRH antibody titer (baseline >4 mm^2) or achieving an SRH antibody titer of >=25 mm^2 (baseline <=4 mm^2) for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain).|Day 22 (21 days after vaccination)|Full analysis set was defined as participants who were randomized and received vaccination with the study drug.||percentage of participants||95% Confidence Interval|Number
641316|NCT02313155|Secondary|Percentage of Participants With Seroprotection in SRH Antibody Titer (Cell Derived Antigen) of >=25 mm^2|Seroprotection rate as measured by SRH antibody titer (vero antigen, live-vero antigen, and madin-darby canine kidney [MDCK] antigen) was defined as percentage of participants with a SRH antibody titer of >=25 mm^2 for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain).|Day 22 (21 days after vaccination)|Full analysis set was defined as participants who were randomized and received vaccination with the study drug.||percentage of participants||95% Confidence Interval|Number
641317|NCT02313155|Secondary|GMT in HI Antibody Titer (Cell Derived Antigen)|GMT in HI antibody titer (vero antigen, live-vero antigen, and madin-darby canine kidney [MDCK] antigen) for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain) was computed along with 95% CI.|Day 22 (21 days after vaccination)|Full analysis set was defined as participants who were randomized and received vaccination with the study drug.||titer||95% Confidence Interval|Geometric Mean
641318|NCT02313155|Secondary|GMFI in HI Antibody Titer (Cell Derived Antigen) From Pre-vaccination to 21 Days After Vaccination|GMFI in HI antibody titer (vero antigen, live-vero antigen, and madin-darby canine kidney [MDCK] antigen) as compared to pre-vaccination was evaluated for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain). Geometric mean and CI were calculated for GMFIs.|Pre-vaccination, 21 Days After vaccination (Day 22)|Full analysis set was defined as participants who were randomized and received vaccination with the study drug.||fold increase||95% Confidence Interval|Geometric Mean
641319|NCT02313155|Secondary|Percentage of Participants With Seroconversion in HI Antibody Titer (Cell Derived Antigen)|Seroconversion rate as measured by the HI antibody titer (vero antigen, live-vero antigen, and madin-darby canine kidney [MDCK] antigen) was defined as percentage of participants achieving a minimal 4-fold increase from the baseline HI antibody titer (baseline >=10) or achieving an HI antibody titer of >=40 (baseline HI <10) for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain).|Day 22 (21 days after vaccination)|Full analysis set was defined as participants who were randomized and received vaccination with the study drug.||percentage of participants||95% Confidence Interval|Number
641320|NCT02313155|Secondary|Percentage of Participants With Seroprotection in HI Antibody Titer (Cell Derived Antigen) of >=40|Seroprotection rate as measured by HI antibody titer (vero antigen, live-vero antigen, and madin-darby canine kidney [MDCK] antigen) was defined as percentage of participants with an HI antibody titer of >=40 for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain).|Day 22 (21 days after vaccination)|Full analysis set was defined as participants who were randomized and received vaccination with the study drug.||percentage of participants||95% Confidence Interval|Number
641321|NCT02313155|Secondary|GMT in SRH Antibody Titer (Egg-derived Antigen)|GMT in SRH antibody titer (egg-derived antigen) for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain) was computed along with 95% CI.|Day 22 (21 days after vaccination)|Full analysis set was defined as participants who were randomized and received vaccination with the study drug.||titer||95% Confidence Interval|Geometric Mean
641322|NCT02313155|Secondary|GMFI in SRH Antibody Titer (Egg-derived Antigen) From Pre-vaccination to 21 Days After Vaccination|GMFI in SRH antibody titer (egg-derived antigen) as compared to baseline pre-vaccination was evaluated for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain). Geometric mean and CI were calculated for GMFIs.|Pre-vaccination, 21 Days after vaccination (Day 22)|Full analysis set was defined as participants who were randomized and received vaccination with the study drug.||fold increase||95% Confidence Interval|Geometric Mean
641323|NCT02313155|Secondary|Percentage of Participants With Seroconversion in SRH Antibody Titer (Egg-Derived Antigen)|Seroconversion rate as measured by the SRH antibody titer (egg-derived antigen) was defined as percentage of participants achieving a minimal 50% increase from the baseline SRH antibody titer (baseline >4 mm^2) or achieving an SRH antibody titer of >=25 mm^2 (baseline <=4 mm^2) for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain).|Day 22 (21 days after vaccination)|Full analysis set was defined as participants who were randomized and received vaccination with the study drug.||percentage of participants||95% Confidence Interval|Number
641324|NCT02313155|Secondary|Percentage of Participants With Seroprotection in SRH Antibody Titer (Egg-derived Antigen) of >=25 mm^2|Seroprotection rate as measured by SRH antibody titer (egg-derived antigen) was defined as percentage of participants with an SRH antibody titer of >=25 mm^2 for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain).|Day 22 (21 days after vaccination)|Full analysis set was defined as participants who were randomized and received vaccination with the study drug.||percentage of participants||95% Confidence Interval|Number
641325|NCT02313155|Secondary|Geometric Mean Titer (GMT) in HI Antibody Titer (Egg-derived Antigen)|GMT in HI antibody titer (egg-derived antigen) for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain) was computed along with 95% CI.|Day 22 (21 days after vaccination)|Full analysis set was defined as participants who were randomized and received vaccination with the study drug.||titer||95% Confidence Interval|Geometric Mean
641326|NCT02313155|Secondary|Change From Baseline in Body Temperature|Change from baseline in body temperature (oral) was reported.|Baseline, Day 22|Safety analysis set was defined as all participants who received vaccination with the study drug.||degree celsius||Standard Deviation|Mean
641327|NCT02313155|Secondary|Change From Baseline in Pulse|Change from baseline in pulse was reported.|Baseline, Day 22|Safety analysis set was defined as all participants who received vaccination with the study drug.||beats per minute||Standard Deviation|Mean
641328|NCT02313155|Secondary|Change From Baseline in Blood Pressure|Change from baseline in systolic and diastolic blood pressure was reported|Baseline, Day 22|Safety analysis set was defined as all participants who received vaccination with the study drug.||millimeter mercury (mmHg)||Standard Deviation|Mean
641329|NCT02313155|Secondary|Number of Participants Reporting Clinically Significant Change From Baseline in Laboratory Values|Laboratory values included hematology, biochemistry and urinalysis tests.|Baseline,up to 21 Days after drug administration (Day 22)|Safety analysis set was defined as all participants who received vaccination with the study drug.||participants|||Number
641362|NCT02311907|Secondary|Percentage of Patients Delaying PC Chemotherapy Secondary to PN|Patients delaying TAXOL/CBDCA secondary to peripheral neuropathy between GSH and placebo arms.|Up to 1 year|||Percentage of participants|||Number
648263|NCT02107014|Primary|Change in GM-CSF From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].|||pg/mL||95% Confidence Interval|Median
641330|NCT02313155|Primary|Geometric Mean Fold Increase (GMFI) in HI Antibody Titer (Egg-derived Antigen) From Pre-vaccination to 21 Days After Vaccination|GMFI in HI antibody titer (egg-derived antigen) as compared to pre-vaccination was evaluated for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain). Geometric mean and CI were calculated for GMFIs.|Pre-vaccination, 21 Days After vaccination (Day 22)|Full analysis set was defined as participants who were randomized and received vaccination with the study drug.||fold increase||95% Confidence Interval|Geometric Mean
641331|NCT02313155|Primary|Percentage of Participants With Seroconversion in Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen)|Seroconversion rate as measured by the HI antibody titer (egg-derived antigen) was defined as percentage of participants achieving a minimal 4-fold increase from the baseline HI antibody titer (baseline >=10) or achieving an HI antibody titer of >=40 (baseline <10) for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain).|Day 22 (21 days after vaccination)|Full analysis set was defined as participants who were randomized and received vaccination with the study drug.||percentage of participants||95% Confidence Interval|Number
641332|NCT02313155|Primary|Percentage of Participants With Seroprotection in Hemagglutination Inhibition (HI) Antibody Titer (Egg-derived Antigen) of >=40.|Seroprotection rate as measured by HI antibody titer (egg-derived antigen) was defined as percentage of participants with the HI antibody titer of >=40 for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain).|Day 22 (21 days after vaccination)|Full analysis set was defined as participants who were randomized and received vaccination with the study drug.||percentage of participants||95% Confidence Interval|Number
641333|NCT02313155|Primary|Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)|An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.|Up to 21 days (Day 22) after vaccination|Safety analysis set was defined as all participants who received vaccination with the study drug.||participants|||Number
641334|NCT02313155|Primary|Number of Participants Reporting Solicited Local and Systemic Adverse Events (AEs)|Number of participants with local reactions (injection site pain, injection site redness, injection site swelling, injection site induration, injection site tenderness, and injection site ecchymosis) and systemic events (pyrexia, malaise, chills, fatigue, headache, sweaty, myalgia, arthralgia, nausea and vomiting) were reported using an electronic diary.|Up to 21 days (Day 22) after vaccination|Safety analysis set was defined as all participants who received vaccination with the study drug.||participants|||Number
641335|NCT02312739|Secondary|Provider Ease of Insertion (0-100mm VAS)|Physician who did the procedure will complete a 0-100mm VAS on ease of insertion of the sterilization devices with anchors 0 equals no difficulty and 100 equals very difficult.|Within 5 minutes after the Essure® procedure|||units on a scale||Standard Deviation|Mean
641336|NCT02312739|Secondary|Patient Satisfaction (5-point Likert Scale)|Patients were asked to rate their overall satisfaction with the procedure using a 5-point Likert scale (Very unsatisfied, Unsatisfied, Neutral, Satisfied, Very satisfied). Results were analyzed to portray the percentage of participants who felt satisfied at the listed interval levels.|Prior to discharge from clinic, approximately 30-45 minutes post-procedure|||percentage of participants|||Number
641337|NCT02312739|Secondary|Change From Baseline in Patient Anxiety Scale After the Procedure|Participants were asked to complete a validated short form of the Spielberger State-Trait Anxiety Inventory (STAI) at baseline and at 3-5 minutes after the in-office sterilization procedure. On the STAI scale, participants rated five statements (I feel calm, I am tense, I feel upset, I am relaxed, I am worried) on a 1 - 4 scale (Not at all, Somewhat, Moderately, Very Much, totaling in a score from 0-20 (0 being least anxious, 20 being the most anxious).|At baseline before the procedure and at 3-5 minutes after the Essure® procedure|||units on a scale||Standard Deviation|Mean
641338|NCT02312739|Primary|Pain Scale Measurement - Maximum Pain Experienced|The maximum pain that was experienced during the procedure is assessed using a 0-100mm VAS with anchors 0 equals no pain and 100 equals worst pain imaginable. It is taken at 3 to 5 minutes following completion of the procedure.|At 3-5 minutes after the procedure|||units on a scale||Standard Deviation|Mean
641339|NCT02312739|Primary|Change From Baseline in Pain Scale Measurement During and After the Procedure|Pain is assessed using a 0-100mm VAS with anchors 0 equals no pain and 100 equals worst pain imaginable. It is taken at baseline, after paracervical block injection and after placement of second Essure® coil. A final pain assessment is done prior to discharge.|At baseline before the procedure, during the procedure after paracervical block injection and after placement of second Essure® coil, and prior to discharge from clinic (approximately 30-45 minutes postprocedure)|||units on a scale||Standard Deviation|Mean
641340|NCT02312726|Other Pre-specified|Provider Ease-of-insertion|The provider who inserts the IUD will be asked to complete a 4-item Likert scale rating perceived difficultly of insertion: 1 = easy; 2 = somewhat easy; 3 = somewhat difficult, 4 = difficult.|Within 5 minutes following postpartum IUD insertion|||participants|||Number
641341|NCT02312726|Secondary|Pain Score: Verbal Rating Scale (VRS)|This is a 4-item ordinal pain scale which has been used for pain level assessment. When prompted, patients will be asked to indicate which level of pain most accurately represents their pain level; 0 = No pain, 1 = Mild pain, 2 = Moderate pain, 3 = Severe pain.|Immediately prior to and within 5 minutes after IUD insertion following vaginal delivery. Women who undergo a postpartum interview will be asked to perform a recal VRS pain assessment|||participants|||Number
641342|NCT02312726|Secondary|Pain Score: Visual Analog Scale (VAS)|This is a validated instrument used extensively in the assessment of acute pain. When prompted, patients will be asked to mark the continuous 100 mm VAS line at the point which most accurately represents their pain level; 0 = no pain, 100 = pain as bad as it could be.|Immediately prior to and within 5 minutes after IUD insertion following vaginal delivery; women who undergo a postpartum interview will be asked to perform a recall VAS pain assessment|||units on a scale||Standard Deviation|Mean
641423|NCT02310750|Primary|Single Ascending Dose (SAD) Cohort: Change From Baseline in Heart Rate at Day 1||Baseline, 24 hours post-dose on Day 1|FAS included all participants who were randomized to treatment and received at least 1 dose of study medication.||bpm||Standard Deviation|Mean
641343|NCT02312726|Primary|Assessment of Women’s Experiences With Ring Forceps Postplacental IUD Placement Through Semi-structured Interviews|A semi-structured interview guide(available in both English and Spanish) which was developed in consultation with an expert in qualitative methodology at the UNM Clinical & Translational Science Center (CTSC), and UNMH family planning experts, will be administered to all participants. The interview will incorporate the following domains of women’s perceptions of the postplacental IUD insertion experience: decisional influence, experience during the procedure, decisional regret, prior knowledge/ awareness of the method and postpartum contraception in general. The interview will conclude with an overall patient satisfaction score measured on a five-point Likert scale: 1 = very dissatisfied, 2 = somewhat dissatisfied, 3 = neutral, 4 = somewhat satisfied, 5 = very satisfied.|Within 24-48 hours after vaginal delivery, prior to hospital discharge|21 participants (out of the 68 included in the study) consented to an interview regarding their experience. We conducted 21 interviews; 9 with women who did not have an epidural and 12 with women who had an epidural.||participants|||Number
641344|NCT02312154|Primary|Global Aesthetic Improvement Scale (Subject)|The therapeutic outcome was assessed by patient self-assessment using the Global Aesthetic Improvement Scale (GAIS), which rates outcome on the following 5-point scale: 3, very much improved; 2, much improved; 1, improved; 0, no change; and -1, worse|12 weeks|||scores on a scale||Standard Deviation|Mean
641345|NCT02312154|Primary|Global Aesthetic Improvement Scale (Investigator)|The therapeutic outcome was assessed by investigator using the Global Aesthetic Improvement Scale (GAIS), which rates outcome on the following 5-point scale: 3, very much improved; 2, much improved; 1, improved; 0, no change; and -1, worse.|12 weeks|||scores on a scale||Standard Deviation|Mean
641346|NCT02312154|Primary|Erythema Index|"We measured an erythema index by a mexameter device (Courage & Khazaka, Cologne, Germany).
The range of erythema index is 0~999 AU(Arbitrary Unit). The range of erythema index was 0 (as non-erythematous as possible) ~999 AU (most erythematous possible)"|12 weeks|||AU (arbitrary unit)||Standard Deviation|Mean
641347|NCT02312154|Primary|Melanin Index|"We measured a melanin index by a mexameter device (Courage & Khazaka, Cologne, Germany).
The range of melanin index was 0 (as bright as possible) ~999 AU (Arbitrary Unit) (most dark possible)."|12 weeks|||AU (arbitrary unit)||Standard Deviation|Mean
641348|NCT02312154|Primary|Elasticity|"We measured a elasticity by a reviscometer device (Courage & Khazaka, Cologne, Germany).
The range of elasticity was 0 (most elastic possible as) ~400 AU(Arbitrary Unit) (inelastic as possible)"|12 weeks|||AU (arbitrary unit)||Standard Deviation|Mean
641349|NCT02312154|Primary|Hydration Level|"We measured a hydration level by a corneometer device (Courage & Khazaka, Cologne, Germany).
The range of hydration level was 0 (as dry as possible) ~120 AU (Arbitrary Unit)(most moist possible)"|12 weeks|||AU (arbitrary unit)||Standard Deviation|Mean
641350|NCT02311972|Other Pre-specified|Exploratory Outcome: Caregiver Satisfaction and Ease of Use|Describe the caregiver satisfaction and ease of use for the InnerSense by using a provider questionnaire. Caregivers will rate the InnerSense feeding tube with traditional feeding tubes used in the Intensive Care Nursery.|First 24 hours of infant life.||||||
641351|NCT02311972|Secondary|Pearson Correlation Coefficient Comparing Thermistor Abdominal Temperature to Esophageal Temperature in Each Infant in the Experimental Arm.|Temperatures measured by the abdomen thermistor will be compared with esophageal temperatures in each infant over 24 hours using pearson correlation coefficient.|Admission to 24 hours of infant life.|Intervention Group Only: Two infants with the InnerSense did not have skin temperatures dowloaded from the data logger due to data logger malfunction and one infant had a Squirrel monitor attached to the InnerSense tube that did not read or log temperatures. Therefore only data from 5 infants was available to analyze.||Pearson Correlation Coefficient|||Number
641352|NCT02311972|Secondary|Percentage of Infants With Hypothermic Temperatures (<36.5° C) at 8 Hours of Infant Life|Axillary temperatures for infants in the InnerSense group and infants in the standard of care group will be compared at 8 hours to determine the percentage of hypothermia in both groups.|8 Hours of Infant Life|||Participants|||Count of Participants
641353|NCT02311972|Secondary|Percentage of Infants With Hypothermic Temperatures (<36.5° C) at 4 Hours of Infant Life|Axillary temperatures for infants in the InnerSense group and infants in the standard of care group will be compared at 4 hours to determine the percentage of hypothermia in both groups.|4 Hours of Infant Life|||Participants|||Count of Participants
641354|NCT02311972|Secondary|Percentage of Infants With Hypothermic Temperatures (<36.5° C) at 1 Hour of Infant Life|Axillary temperatures for infants in the InnerSense group and infants in the standard of care group will be compared at 1 hour to determine the percentage of hypothermia in both groups.|1 Hour of Infant Life|||Participants|||Count of Participants
641355|NCT02311972|Secondary|Percentage of Infants With Hypothermic Temperatures (<36.5° C) Upon Admission|Axillary temperatures for infants in the InnerSense group and infants in the standard of care group will be compared on admission to determine the percentage of hypothermia in both groups.|Admission|||Participants|||Count of Participants
641356|NCT02311972|Primary|Mean Axillary Temperature at 4 Hours of Infant Life|The mean axillary temperature at 4 hours of age will be compared for infants in the InnerSense group and the standard of care group to determine if a significant difference is seen at 4 hours of life.|4 Hours of Infant Life|||Degrees Celsius||Standard Deviation|Mean
641357|NCT02311972|Primary|Mean Axillary Admission Temperature|Mean axillary temperatures upon Admission from infants in the InnerSense group and the standard of care group will be compared to determine if a significant difference|Admission|||Degrees Celsius||Standard Deviation|Mean
641358|NCT02311907|Secondary|Times to Onset of CTCAE Grade 3+ PN|Time to grade 3+ CIPN between GSH and placebo arms.|Up to 5 years from registration|||days||95% Confidence Interval|Median
641359|NCT02311907|Secondary|Times to Onset of CTCAE Grade 2+ PN|Compare time to grade 2+ CIPN between GSH and placebo arms.|Up to 1 year|Number of Participants analyzed is 93 for Arm I due to error in date entered.||days||Standard Error|Median
641360|NCT02311907|Secondary|Percentage of Patients With Grade 2+ and Grade 3+ Paclitaxel/Carboplatin-induced (PCI) Peripheral Neuropathy (PN) According to the Common Terminology Criteria for Adverse Events (CTCAE) Neuropathy Scale|Proportion of grade 2+ and grade 3+ chemotherapy induced peripheral neuropathy (CIPN) at any time during or at the end of the TAXOL/CBDCA based chemotherapy between GSH and placebo arms. Neuropathy scale has grades 1 through 5 (1-mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening and Grade 5 Death related to AE).|Up to 1 year|||percentage of participants|||Number
641363|NCT02311907|Secondary|Paclitaxel Acute Pain Syndrome Incidence and Severity Between GSH and Placebo Arms|Descriptive statistics will be used to describe TAXOL/CBDCA acute pain syndrome incidence/severity between GSH and placebo arms. Pain was scored on a scale from 0-10, where 0 = ‘No aches or pains’ and 10 = ‘Aches or pains as bad as can be.’|Up to 1 year|||units on a scale||Full Range|Median
641364|NCT02311907|Secondary|Change in Patient Reported Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Ovarian (FACT-O) and Patient Daily-symptom Questionnaires Over Time.|Quality of life was measured by FACT-O (on a 0 to 100 scale, higher scores represent better life quality) from baseline and at the end of TAXOL/CBDCA. The change in Quality of Life was calculated as the difference between baseline measure and end of treatment measure (with range from -100 to 100). A negative change represents a worsening in QOL from baseline to one year. Abbreviations used: Change from Baseline (chg from bsl)|Baseline to 1 year|FACT-O Change from Baseline to cycle 6 data available for 34 patients.||units on a scale||Full Range|Median
641365|NCT02311907|Secondary|Recurrence-free Survival (for Patients Without Clinical Evidence of Disease)|A log-rank test and a Kaplan-Meier curve will be used to compare the recurrence free survival between GSH and placebo arms (for ovarian/fallopian tube/primary peritoneal patients only).|Up to 1 year|Patients without clinical evidence of disease.||Median survival time in days||95% Confidence Interval|Median
641366|NCT02311907|Primary|Paclitaxel/Carboplatin (PC) Induced Peripheral Neuropathy as Assessed by EORTC QLQ-CIPN20 (European Organization for Research and Treatment of Cancer (EORTC), Quality of Life (QLQ), Chemotherapy Induced Peripheral Neuropathy 20 (CIPN20)).|The CIPN sensory subscale will be calculated by standard scoring algorithm and converted to 0-100 scale (higher scores indicated less symptoms and better quality of life). Generalized linear models (repeated measures analysis of variance [ANOVA] if data are complete) will be used to compare the CIPN between Glutathione (GSH) and placebo arms.|Every 28 day cycle, up to 6 cycles.|||Units on a scale 1-100||Standard Error|Least Squares Mean
641367|NCT02311881|Secondary|Patient Global Assessment of Response to Therapy (PGART)|The PGART is a global assessment of the participant’s response to therapy, was measured using on a 5 point Likert scale as follows: 0=None (no good at all, ineffective), 1= Poor (some effect, but unsatisfactory), 2= Fair (reasonable effect, but could be better), 3= Good (satisfactory effect with occasional episodes of pain and/or stiffness), 4= Excellent (ideal response, virtually pain-free). Mean PGART scores from 5 point Likert scale was calculated periodically (at Week 4, Week 8, Week 12) for the 12 week treatment period.|Week 4, Week 8, Week 12|Analysis for this outcome was conducted on mITT population which included all participants included in the ITT population (included all randomized participants that received the study treatment & had at least one post-baseline efficacy assessment), except participants randomized in a site where good clinical practice issues were identified.||score on a scale||Standard Deviation|Mean
641368|NCT02311881|Secondary|Mean Change From Baseline in Chronic Pain Sleep Inventory (CPSI)|Chronic Pain Sleep Inventory (CPSI) was assessed, based on the three questions: CPSI-1-'Trouble falling asleep': How often the participant had trouble falling asleep? , CPSI-3-'Awakening due to pain at night': How often the subject was awakened by pain during the night, CPSI-4- Awakening due to pain in the morning': How often the participant was awakened by pain in the morning? The participants responded to these questions via 0-100mm VAS, ranging from 0 (never) to 100 (always). Sleep problem index (SPI) was calculated as mean of these three CPSI questions, ranging from 0 (never affected by pain during sleep) to 100 (always affected by pain during sleep).|Baseline, Week 4, Week 8, Week 12|Analysis for this outcome was conducted on mITT population which included all participants included in the ITT population (included all randomized participants that received the study treatment & had at least one post-baseline efficacy assessment), except participant randomized in a site where good clinical practice issues were identified.||mm||Standard Deviation|Mean
641369|NCT02311881|Secondary|Mean Number of Rescue Medication Pills Taken Per Day up to 12 Weeks|Participants recorded use of rescue medication daily in their patient diary. The mean number of doses of rescue medications taken per day during the 12-week treatment period was calculated.|every day up to 12 weeks|Analysis for this outcome was conducted on mITT population which included all participants included in the ITT population (included all randomized participants that received the study treatment & had at least one post-baseline efficacy assessment), except participant randomized in a site where good clinical practice issues were identified.||number of rescue medication pills/day||Standard Deviation|Mean
641370|NCT02311881|Secondary|Mean Change From Baseline in Daily Pain, Daily Stiffness and Pain/Stiffness (Composite) at Week 12|Participants assessed their daily pain and stiffness each morning (upon awakening) during the 12-week treatment period using an 11-point Numerical Rating Scale (NRS), ranging from 0 (no pain / no stiffness) to 10 (extreme pain / extreme stiffness). Composite daily pain/stiffness score was calculated as sum of scores of pain and stiffness each morning divided by 2, ranging from 0 (no pain/stiffness) to 10 (extreme pain/stiffness). The mean of pain, mean of stiffness, and mean pain /stiffness composite score was calculated. Change from baseline was calculated as the difference between Daily Pain, stiffness and composite score each morning with that at baseline and was presented per week. A negative change from Baseline indicated improvement.|Baseline, Week 12|Analysis for this outcome was conducted on mITT population which included all participants included in the ITT population (included all randomized participants that received the study treatment & had at least one post-baseline efficacy assessment), except participants randomized in a site where good clinical practices issues were identified.||score on a scale||Standard Deviation|Mean
641371|NCT02311881|Secondary|Number of Participants Classified as Responder|A participant was considered a “responder” if his/her improvement from baseline (change from baseline at week 12) satisfied at least one of the two criteria high’ or ‘moderate’ improvement as follows:- High improvement: 50% improvement from baseline in the last available WOMAC pain score or 60% improvement from baseline in the last available WOMAC physical function score. Moderate improvement: Fulfills two out of three criteria: 30% improvement from baseline in the last available WOMAC Pain score, 20% improvement from baseline in the last available WOMAC Physical Function score, 25% improvement from baseline in the last available GPAOA.|Baseline, Week 12|Analysis for this outcome was conducted on mITT population which included all participants included in the ITT population (included all randomized participants that received the study treatment & had at least one post-baseline efficacy assessment), except participants randomized in a site where good clinical practice issues were identified.||participants|||Number
648264|NCT02107014|Primary|Change in G-CSF From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].|||pg/mL||95% Confidence Interval|Median
641372|NCT02311881|Secondary|Mean Change From Baseline in Global Patient Assessment of Arthritis (GPAOA)|"Participants performed an instantaneous GPAOA via a 0-100mm VAS, ranging from 0 (best ever) to 100 (worst ever) with respect to With respect to your arthritis condition, how would you describe yourself now? GPAOA was calculated periodically during the 12 week treatment period."|Baseline, Week 4, Week 8, Week 12|Analysis for this outcome was conducted on mITT population which included all participants included in the ITT population (included all randomized participants that received the study treatment & had at least one post-baseline efficacy assessment), except participants randomized in a site where good clinical practice issues were identified.||mm||Standard Deviation|Mean
641373|NCT02311881|Secondary|Time-weighted Mean Change From Baseline in WOMAC Total Index Through Week 12 of Treatment|The WOMAC Osteoarthritis Index is a 24-item questionnaire that assesses pain, physical function, and stiffness in the target joint. The Total Index Score included the WOMAC Pain Score (5 questions about pain where: 0=no pain to 100=extreme pain), the WOMAC Physical Function score (17 questions about the difficulty of daily activities where: 0=no difficulty to 100=extreme difficulty) and the WOMAC Stiffness Score (2 questions about stiffness where: 0=no stiffness to 100=extreme stiffness). WOMAC Total Index was calculated at baseline and each time point as sum of scores of all 24 WOMAC questions divided by 2400, ranging from 0 (no pain/difficulty/stiffness) to 1 (extreme pain/ difficulty/stiffness). Change from baseline was calculated as WOMAC Total Index at specific time point minus WOMAC Total Index at baseline. A negative change from Baseline indicated improvement.|Baseline up to week 12|Analysis for this outcome was conducted on mITT population which included all participants included in the ITT population (included all randomized participants that received the study treatment & had at least one post-baseline efficacy assessment), except participants randomized in a site where good clinical practices issues were identified.||mm||Standard Deviation|Mean
641374|NCT02311881|Secondary|Time Weighted Mean Change From Baseline in WOMAC Stiffness Through Week 12 of Treatment|The WOMAC Osteoarthritis Index is a 24-item questionnaire that assesses pain, physical function, and stiffness in the target joint. WOMAC stiffness was measured using VAS ranging from 0mm (no stiffness) to 100mm (maximum stiffness) at baseline and at week 1, 2, 4, 8, and 12. Lower values represent a better outcome. At each time point the assessment included 2 WOMAC stiffness categories: 1- after awakening in the morning; 2- later in the day. Mean WOMAC stiffness was calculated for baseline and each time point (sum of scores for 2 stiffness categories divided by 2). Change from baseline was calculated for each visit as mean WOMAC stiffness subscale score at specific time point minus mean WOMAC stiffness subscale score at baseline. A negative change from Baseline indicated improvement. The time-weighted mean change from baseline was calculated as area under the curve of change from baseline divided by nominal time of the last on-therapy visit (week 12) from randomization (baseline).|Baseline up to week 12|Analysis for this outcome was conducted on mITT population which included all participants included in the ITT population (included all randomized participants that received the study treatment & had at least one post-baseline efficacy assessment), except participants randomized in a site where good clinical practices issues were identified.||mm||Standard Deviation|Mean
641375|NCT02311881|Secondary|Time Weighted Mean Change From Baseline in WOMAC Physical Function Through Week 12 of Treatment|The WOMAC Osteoarthritis Index is a 24-item questionnaire that assesses pain, physical function, and stiffness in the target joint. WOMAC Physical function was measured using VAS ranging from 0mm (no difficulty) to 100mm (extreme difficulty) at baseline and at week 1, 2, 4, 8, and 12. Lower values represent a better outcome. At each time point the assessment included 17 WOMAC Physical function categories. Mean WOMAC Physical function was calculated for baseline and each time point (sum of scores for 17 physical function categories divided by 17). Change from baseline was calculated for each visit as mean WOMAC physical function subscale score minus mean baseline WOMAC physical function subscale score. A negative change from Baseline indicated improvement. The time-weighted mean change was calculated as the area under the curve of change from baseline divided by the nominal time of the last on-therapy visit (week 12) from randomization (baseline).|Baseline up to Week 12|Analysis for this outcome was conducted on mITT population which included all participants included in the ITT population (included all randomized participants that received the study treatment & had at least one post-baseline efficacy assessment), except participants randomized in a site where good clinical practices issues were identified.||mm||Standard Deviation|Mean
641376|NCT02311881|Primary|Time-weighted Mean Change From Baseline in Western Ontario McMaster (WOMAC) Pain Through Week 12 of Treatment|The WOMAC Osteoarthritis Index is a 24-item questionnaire that assesses pain, physical function, and stiffness in the target joint. WOMAC Pain was measured using visual analogue scale (VAS) ranging from 0mm (no pain) to 100mm (extreme pain) at baseline and at week 1, 2, 4, 8, and 12. Lower values represent a better outcome. At each time point the assessment included 5 WOMAC Pain items: 1-walking on flat, 2-going up down stairs, 3-at night while in bed, 4-sitting or lying; 5-standing upright. Mean WOMAC Pain subscale score was calculated at each visit as the sum of 5 pain category scores divided by 5. Change from baseline was calculated for each visit as the mean WOMAC Pain subscale score minus the mean baseline WOMAC Pain subscale score. A negative change from Baseline indicated improvement. The time-weighted mean change was calculated as the area under the curve of change from baseline divided by the nominal time of the last on-therapy visit (week 12) from randomization (baseline).|Baseline up to week 12|Modified intent to treat (mITT) population which included all participants included in the ITT population (included all randomized participants that received the study treatment & had at least one post-baseline efficacy assessment), except participants randomized in a site where good clinical practice issues were identified.||millimeter(mm)||Standard Error|Least Squares Mean
641377|NCT02311309|Secondary|Lowest Hemoglobin|lowest peroperative hemoglobin concentration|one day||||||
641378|NCT02311309|Secondary|Preoperative Anemia|proportion of patients with preoperative anemia|one day||||||
641379|NCT02311309|Secondary|Transfusions|transfusion pattern in the whole cohort|one day|||number of participants|||Number
641380|NCT02311309|Primary|Unanticipated Bleeding|From arrival in operating room until the patients leave post anesthesia care unit|one day|||percentage of participants|||Number
641421|NCT02310750|Primary|Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Heart Rate at Day 28||Baseline, 16 hours post-dose on Day 28|FAS included all participants who were randomized to treatment and received at least 1 dose of study medication. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||bpm||Standard Deviation|Mean
641381|NCT02310776|Primary|Ratio of Lesions Detected With Automated Breast Ultrasound (ABVS) Compared to the Standard of Care Handheld (HH) Breast Ultrasound (US)|Solid lesions found on whole breast 3D supine automated breast ultrasound are compared in number and identity with solid lesions found using high resolution standard of care handheld breast ultrasound performed by physicians|Time for performance of ABVS was measured separately from interpretation time. Time for performance of real time HH whole breast US was also measured. For HH US physician performed, performance included interpretation.|Each participant was evaluated based on Breast Imaging-Reporting and Data System (BI-RADS) assessment for Automated and Handheld breast ultrasound exams. If participant had more than one lesion, each lesion was assessed and listed separately and if a participant did not have a lesion, she was entered once.||Detection ratio of lesions|Participants|95% Confidence Interval|Number
641382|NCT02310750|Secondary|Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56||Baseline, Day 4, 6 ,8,10, 13, 14, 21, 28, 35, 42, 56|PD analysis set included all randomized and treated participants who had at least 1 of the PD parameters of interest. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||cells/mm^3||Standard Deviation|Mean
641383|NCT02310750|Secondary|Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 8, 10, 11, 14 and 28||Baseline, Day 4, 8, 10, 11, 14, 28|PD analysis set included all randomized and treated participants who had at least 1 of the PD parameters of interest. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||cells/mm^3||Standard Deviation|Mean
641384|NCT02310750|Secondary|Single Ascending Dose (SAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 2, 5, 8||Baseline, Day 2, 5, 8|PD analysis set included all randomized and treated participants who had at least 1 of the PD parameters of interest. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||cells/mm^3||Standard Deviation|Mean
641385|NCT02310750|Secondary|Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Neutrophil Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56||Baseline, Day 4, 6 ,8,10, 13, 14, 21, 28, 35, 42, 56|PD analysis set included all randomized and treated participants who had at least 1 of the PD parameters of interest. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||cells/mm^3||Standard Deviation|Mean
641386|NCT02310750|Secondary|Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Neutrophil Counts at Day 4, 8, 10, 11, 14, 28||Baseline, Day 4, 8, 10, 11, 14, 28|PD analysis set included all randomized and treated participants who had at least 1 of the PD parameters of interest. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||cells/mm^3||Standard Deviation|Mean
641387|NCT02310750|Secondary|Single Ascending Dose (SAD) Cohort: Change From Baseline in Neutrophil Counts at Day 2, 5 and 8||Baseline, Day 2, 5, 8|PD analysis set included all randomized and treated participants who had at least 1 of the PD parameters of interest. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||cells per millimeter cube (cells/mm^3)||Standard Deviation|Mean
641388|NCT02310750|Secondary|Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 7, 14, 21, 28, 29, 35 and 56|Serum samples for hsCRP were analyzed using a validated analytical assay. Reference range for measurement of CRP was 0.015 to 2.0 mg/dL. LLOQ for hsCRP was 0.03 mg/dL and limit of detection was 0.015 mg/dL.|Baseline, Day 2, 5 ,7,14, 21, 28, 29, 35, 56|PD analysis set included all randomized and treated participants who had at least 1 of the PD parameters of interest. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||mg/dL||Standard Deviation|Mean
641389|NCT02310750|Secondary|Multiple Ascending Dose (MAD) Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 10, 11, 28|Serum samples for hsCRP were analyzed using a validated analytical assay. Reference range for measurement of CRP was 0.015 to 2.0 mg/dL. LLOQ for hsCRP was 0.03 mg/dL and limit of detection was 0.015 mg/dL.|Baseline, Day 2, 5, 10, 11, 28|PD analysis set included all randomized and treated participants who had at least 1 of the PD parameters of interest. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||mg/dL||Standard Deviation|Mean
641390|NCT02310750|Secondary|Single Ascending Dose (SAD) Cohort: High Sensitivity C-reactive Protein (hsCRP) Concentration in Serum at Baseline|Serum samples for hsCRP were analyzed using a validated analytical assay. Reference range for measurement of CRP was 0.015 to 2.0 mg/dL. LLOQ for hsCRP was 0.03 mg/dL and limit of detection was 0.015 mg/dL.|Baseline|PD analysis set included all randomized and treated participants who had at least 1 of the PD parameters of interest.||milligram per deciliter (mg/dL)||Standard Deviation|Mean
641391|NCT02310750|Secondary|Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Interferon Gamma-Induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 7, 14, 21, 28, 29, 35, 56|Serum samples for IP-10 were analyzed using a validated analytical assay. Lower limit of quantification (LLOQ) for IP-10 was 10 pg/mL.|Baseline, Day 2, 5, 7, 14, 21, 28, 29, 35, 56|PD analysis set included all randomized and treated participants who had at least 1 of the PD parameters of interest. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||pg/mL||Standard Deviation|Mean
641392|NCT02310750|Secondary|Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Interferon Gamma-induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 10, 11, 28|Serum samples for IP-10 were analyzed using a validated analytical assay. LLOQ for IP-10 was 10 pg/mL.|Baseline, Day 2, 5, 10, 11, 28|PD analysis set included all randomized and treated participants who had at least 1 of the PD parameters of. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||pg/mL||Standard Deviation|Mean
641393|NCT02310750|Secondary|Single Ascending Dose (SAD) Cohort: Interferon Gamma-induced Protein 10 (IP-10) Concentration in Serum at Baseline|Serum samples for IP-10 were analyzed using a validated analytical assay. Lower limit of quantification (LLOQ) for IP-10 was 10 pg/mL.|Baseline|Pharmacodynamic (PD) analysis set included all randomized and treated participants who had at least 1 of the PD parameters of interest.||picogram per milliliter (pg/mL)||Standard Deviation|Mean
641662|NCT02299869|Primary|Cosmetic Appearance Preference|Participant's subjective preference for cosmetic appearance. 3 point Likert Scale. 1=prefer CVI-test lens 2=prefer Competitor-control lens, 3=no preference|20 minutes|||participants|||Number
641394|NCT02310750|Secondary|Multiple Ascending Dose (MAD) Cohort: Renal Clearance|Renal clearance was calculated as amount of drug recovered unchanged in urine during the dosing interval tau (Aetau) divided by area under the plasma concentration time-curve from time zero to end of dosing interval (AUCtau), where dosing interval was 24 hours for MAD once daily cohorts, 12 hours for MAD twice daily cohort.|0-24 hours on Day 10|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, ‘N’ signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo Once Daily and Twice Daily: MAD Cohort arms.||Liter per hour||Geometric Coefficient of Variation|Geometric Mean
641395|NCT02310750|Secondary|Multiple Ascending Dose (MAD) Cohort: Percentage of Dose of PF-06700841 Recovered Unchanged in the Urine Over the Time Interval Tau (Aetau%)|Aetau% was calculated as: 100*Aetau/dose. Aetau is the amount of drug recovered unchanged in urine during the dosing interval (tau), where dosing interval was 24 hours for MAD once daily cohorts, 12 hours for MAD twice daily cohort.|0-24 hours on Day 10|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, ‘N’ signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo Once Daily and Twice Daily: MAD Cohort arms.||percentage of dose recovered||Geometric Coefficient of Variation|Geometric Mean
641396|NCT02310750|Secondary|Multiple Ascending Dose (MAD) Cohort: Amount of PF-06700841 Recovered Unchanged in the Urine Over the Time Interval Tau (Aetau)|Aetau is the amount of drug recovered unchanged in urine during the dosing interval (tau), where dosing interval was 24 hours for MAD once daily cohorts, 12 hours for MAD twice daily cohort.|0-24 hour on Day 10|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, ‘N’ signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo Once Daily and Twice Daily: MAD Cohort arms.||milligram||Geometric Coefficient of Variation|Geometric Mean
641397|NCT02310750|Secondary|Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Peak-Trough Fluctuation (PTF) of PF-06700841|PTF was calculated as: Cmax-Cmin/Cavg. Cmax is the maximum observed plasma concentration of PF-06700841. Cmin is the minimum observed plasma concentration of PF-06700841. Cavg is the average observed plasma concentration of PF-06700841 calculated as area under the plasma concentration-time curve during a dosing Interval (AUC[tau]) divided by the dosing interval (tau), where dosing interval was 24 hours for MAD once daily cohorts, 12 hours for MAD twice daily cohort and 24 hours for MAD Psoriasis cohort.|MAD: pre­-dose 0.5, 1, 2, 4, 6, 8, 12, 24 hour post­-dose on Day 10; MAD Psoriasis: pre­-dose, 0.5,1,2,4,6,8,12,16,24 hours post-dose on Day 28|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, ‘N’ signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo: MAD Cohort, MAD Psoriasis Cohort arm.||ratio||Geometric Coefficient of Variation|Geometric Mean
641398|NCT02310750|Secondary|Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Apparent Clearance (CL/F) of PF-06700841|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. Clearance obtained after oral dose is influenced by the fraction of the dose absorbed. CL/F =Dose of PF-06700841/AUCinf.|SAD: pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hour post-dose on Day 1; MAD: pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hour post-dose on Day 10; MAD Psoriasis: pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose on Day 28|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, ‘N’ signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo: SAD Cohort, MAD Cohort, MAD Psoriasis Cohort arm.||Liter per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
641399|NCT02310750|Secondary|Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Apparent Volume of Distribution (Vz/F) of PF-06700841|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|SAD: pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hour post-dose on Day 1; MAD: pre-dose 0.5, 1, 2, 4, 6, 8, 12, 24 hour post-dose on Day 10; MAD Psoriasis: pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose on Day 28|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, ‘N’ signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo: SAD Cohort, MAD Cohort, MAD Psoriasis Cohort arm.||liter||Standard Deviation|Mean
641400|NCT02310750|Secondary|Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Mean Residence Time (MRT) of PF-06700841|MRT= AUMCinf/AUCinf, where AUMCinf is the area under the first moment curve from time 0 extrapolated to infinite time, calculated using the linear/log trapezoidal method.|SAD: pre­-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hour post-dose on Day 1; MAD: pre­-dose 0.5, 1, 2, 4, 6, 8, 12, 24 hour post­-dose on Day 10; MAD Psoriasis: pre­-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose on Day 28|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, ‘N’ signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo: SAD Cohort, MAD Cohort, MAD Psoriasis Cohort arm.||hour||Geometric Coefficient of Variation|Geometric Mean
641401|NCT02310750|Secondary|Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Plasma Decay Half-Life (t1/2) of PF-06700841|Plasma decay half-life is the time measured for the plasma concentration of PF-06700841 to decrease by one half.|SAD: pre-­dose, 0.5,1,2,4,6,8,12,16,24,36,48,72,96 hour post-dose on Day 1; MAD: pre­-dose 0.5,1,2,4,6,8,12,24 hour post-dose on Day 10; MAD Psoriasis: pre­-dose, 0.5,1,2,4,6,8,12,16,24 hours post-dose on Day 28|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, ‘N’ signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo: SAD Cohort, MAD Cohort, MAD Psoriasis Cohort arm.||hour||Standard Deviation|Mean
641478|NCT02308787|Other Pre-specified|Procedure Duration||Participants were followed for the duration of the procedure and an average of 2.5 hours after the procedure|Data were collected for 12 subjects who underwent a total of 20 PLTD procedures at 2 European sites.||minutes|Participants|Standard Deviation|Mean
641402|NCT02310750|Secondary|Multiple Ascending Dose (MAD) Cohort: Dose Normalized Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau[dn]) of PF-06700841|Area under the concentration curve from time 0 to end of dosing interval (AUCtau), where dosing interval was 24 hours for MAD once daily cohorts, 12 hours for MAD twice daily cohort. AUCtau(dn) was calculated by dividing AUCtau by the exact dose of of PF-06700841 (in mg) administered to a participant.|pre-dose 0.5,1,2,4,6,8,12,24 hour post-dose on Day 10|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, ‘N’ signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo Once Daily and Twice Daily: MAD Cohort arms.||[ng*hr/mL]/mg||Geometric Coefficient of Variation|Geometric Mean
641403|NCT02310750|Secondary|Single Ascending Dose (SAD) Cohort: Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast[dn]) of PF-06700841|Area under the plasma concentration time-curve from time zero to the time of last measured concentration (AUClast). AUClast(dn) was calculated by dividing AUClast by the exact dose of of PF-06700841 (in mg) administered to a participant.|Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hour post dose on Day 1|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, ‘N’ signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo: SAD Cohort arm.||[ng*hr/mL]/mg||Geometric Coefficient of Variation|Geometric Mean
641404|NCT02310750|Secondary|Single Ascending Dose (SAD) Cohort: Dose Normalized Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf[dn]) of PF-06700841|AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). AUCinf(dn) was calculated by dividing AUCinf by the exact dose of PF-06700841 (in mg) administered to a participant.|pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hour post dose on Day 1|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, ‘N’ signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo: SAD Cohort arm.||[nanogram*hour/milliliter]/milligram||Geometric Coefficient of Variation|Geometric Mean
641405|NCT02310750|Secondary|Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Dose Normalized Maximum Observed Plasma Concentration (Cmax[dn]) of PF-06700841|Dose normalized (dn) Cmax was calculated by dividing Cmax by the exact dose of PF 06700841 (in mg) administered to a participant.|SAD: pre-dose, 0.5,1,2,4,6,8,12,16,24,36,48,72,96 hour post dose on Day 1; MAD: pre-dose 0.5,1,2,4,6,8,12,24 hour post-dose on Day 10; MAD Psoriasis: pre-dose, 0.5,1,2,4,6,8,12,16,24 hours post dose on Day 28|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, ‘N’ signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo: SAD Cohort, MAD Cohort, MAD Psoriasis Cohort arm.||[nanogram/milliliter]/milligram||Geometric Coefficient of Variation|Geometric Mean
641406|NCT02310750|Secondary|Single Ascending Dose (SAD) Cohort: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-06700841|Area under the plasma concentration time-curve from time zero to the time of last measured concentration (AUClast).|pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hour post dose on Day 1|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, ‘N’ signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo: SAD Cohort arm||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
641407|NCT02310750|Secondary|Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06700841|Area under the plasma concentration versus time curve from time 0 to end of dosing interval (AUCtau), where dosing interval was 24 hours for MAD once daily cohorts, 12 hours for MAD twice daily cohort and 24 hours for MAD Psoriasis cohort.|MAD: pre­dose 0.5, 1, 2, 4, 6, 8, 12, 24 hour post­dose on Day 10; MAD Psoriasis: pre­dose, 0.5,1,2,4,6,8,12,16,24 hours post dose on Day 28|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, ‘N’ signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo: MAD Cohort, MAD Psoriasis Cohort arm||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
641408|NCT02310750|Secondary|Single Ascending Dose (SAD) Cohort: Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-06700841|AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf).|pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hour post dose on Day 1|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, ‘N’ signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo: SAD Cohort arm||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
641409|NCT02310750|Secondary|Food Effect Cohort: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-­06700841||Pre-­dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 hours post dose on Day 1|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest.||hour||Full Range|Median
641410|NCT02310750|Secondary|Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06700841||SAD: pre-dose, 0.5,1,2,4,6,8,12,16,24,36,48,72,96 hour post dose on Day 1; MAD: pre-dose 0.5,1,2,4,6,8,12,24 hour post-dose on Day 10; MAD Psoriasis: pre-dose, 0.5,1,2,4,6,8,12,16,24 hours post dose on Day 28|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, ‘N’ signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo: SAD Cohort, MAD Cohort, MAD Psoriasis Cohort arm||hour||Full Range|Median
641422|NCT02310750|Primary|Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Heart Rate at Day 10||Baseline, 16 hours post-dose on Day 10|FAS included all participants who were randomized to treatment and received at least 1 dose of study medication. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||bpm||Standard Deviation|Mean
641411|NCT02310750|Secondary|Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Maximum Observed Plasma Concentration (Cmax) of PF-06700841||SAD: pre-dose, 0.5,1,2,4,6,8,12,16,24,36,48,72,96 hour post dose on Day 1; MAD: pre-dose 0.5,1,2,4,6,8,12,24 hour post-dose on Day 10; MAD Psoriasis: pre-dose, 0.5,1,2,4,6,8,12,16,24 hours post dose on Day 28|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, ‘N’ signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo: SAD Cohort, MAD Cohort, MAD Psoriasis Cohort arm.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
641412|NCT02310750|Primary|Food Effect Cohort: Maximum Observed Plasma Concentration (Cmax) of PF-06700841||pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 hours post dose on Day 1|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
641413|NCT02310750|Primary|Food Effect Cohort: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-06700841|Area under the plasma concentration time-curve from time zero to the time of last measured concentration (AUClast).|pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 hours post dose on Day 1|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
641414|NCT02310750|Primary|Food Effect Cohort: Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-06700841|AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf).|Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 hours post dose on Day 1|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.||nanogram*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
641415|NCT02310750|Primary|Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Creatinine Clearance at Day 28|Creatinine clearance is a measure of kidney function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time.|Baseline, 16 hours post-dose on Day 28|FAS included all participants who were randomized to treatment and received at least 1 dose of study medication. Here, ‘N’ signifies those participants who were evaluable for this outcome measure.||mL/min||Standard Deviation|Mean
641416|NCT02310750|Primary|Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Change From Baseline in Creatinine Clearance at Day 10|Creatinine clearance is a measure of kidney function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time.|Baseline, 16 hours post-dose on Day 10|FAS included all participants who were randomized to treatment and received at least 1 dose of study medication. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||mL/min||Standard Deviation|Mean
641417|NCT02310750|Primary|Single Ascending Dose (SAD) Cohort: Change From Baseline in Creatinine Clearance at Day 1|Creatinine clearance is a measure of kidney function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time.|Baseline, 24 hours post-dose on Day 1|FAS included all participants who were randomized to treatment and received at least 1 dose of study medication. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||milliliter per minute (mL/min)||Standard Deviation|Mean
641418|NCT02310750|Primary|Number of Participants With Laboratory Abnormalities|Criteria for abnormality:hematology: hemoglobin, hematocrit, red blood cell count: less than(<) 0.8*lower limit of normal (LLN); mean corpuscular volume; mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration: <0.9*LLN,>1.1*upper limit of normal (ULN); platelets: <0.5*LLN,>1.75*ULN, white blood cell count: <0.6*LLN, >1.5*ULN; lymphocytes, total neutrophils: <0.8*LLN, >1.2*ULN; eosinophils, basophils, monocytes: >1.2*ULN; coagulation: activated partial thromboplastin time, prothrombin, prothrombin international ratio: >1.1*ULN; liver function: bilirubin: >1.5*ULN; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: >3.0*ULN; protein, albumin: <0.8*LLN></0>1.2*ULN; renal function:blood urea nitrogen,creatinine: >1.3*ULN; uric acid: >1.2*ULN; electrolytes: sodium, potassium, chloride, calcium, bicarbonate: <0.9*LLN,>1.1*ULN; urinalysis: pH<4.5, >8; glucose, protein, blood, ketones, urobilinogen, bilirubin, nitrite; Other(glucose: <0.6*LLN,>1.5*ULN)|SAD Cohort: Baseline up to Day 8, MAD Cohort: Baseline up to Day 28, MAD Psoriasis Cohort: Baseline up to Day 56, Food Effect Cohort: Baseline up to Day 37|FAS included all participants who were randomized to treatment and received at least 1 dose of study medication.||participants|||Number
641419|NCT02310750|Primary|Number of Adverse Events (AEs) According to Severity|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs were classified according to the severity in 3 categories a) mild – AEs does not interfere with participant’s usual function b) moderate – AEs interferes to some extent with participant’s usual function c) severe – AEs interferes significantly with participant’s usual function.|SAD Cohort: Baseline up to Day 8, MAD Cohort: Baseline up to Day 28, MAD Psoriasis Cohort: Baseline up to Day 56, Food Effect Cohort: Baseline up to Day 37|FAS included all participants who were randomized to treatment and received at least 1 dose of study medication.||adverse events|||Number
641420|NCT02310750|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; Initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug up to the end of study (up to Day 8 in SAD cohort, Day 28 in MAD cohort, Day 56 in MAD Psoriasis cohort, Day 37 in Food effect cohort), that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAE and non-SAE.|SAD Cohort: Baseline up to Day 8, MAD Cohort: Baseline up to Day 28, MAD Psoriasis Cohort: Baseline up to Day 56, Food Effect Cohort: Baseline up to Day 37|FAS included all participants who were randomized to treatment and received at least 1 dose of study medication.||participants|||Number
643876|NCT02226198|Secondary|TC/HDL C|Efficacy in terms of total cholesterol (TC) / high density lipoprotein cholesterol (HDL C)|Samples taken at Day 42 (week 6) and Day 84 (week 12)|||ratio||Standard Deviation|Mean
641424|NCT02310750|Primary|Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 28||Baseline, 16 hours post-dose on Day 28|FAS included all participants who received at least 1 dose of study medication. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||msec||Standard Deviation|Mean
641425|NCT02310750|Primary|Multiple Ascending Dose (MAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 10||Baseline, 16 hours post-dose on Day 10|FAS included all participants who were randomized to treatment and received at least 1 dose of study medication. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||msec||Standard Deviation|Mean
641426|NCT02310750|Primary|Single Ascending Dose (SAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 1||Baseline, 24 hours post-dose on Day 1|FAS included all participants who were randomized to treatment and received at least 1 dose of study medication.||millisecond (msec)||Standard Deviation|Mean
641427|NCT02310750|Primary|Number of Participants With Change From Baseline in Physical Examinations|Physical examinations included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems.|SAD Cohort: Baseline up to Day 8, MAD Cohort: Baseline up to Day 28, MAD Psoriasis Cohort: Baseline up to Day 56, Food Effect Cohort: Baseline up to Day 37|FAS included all participants who were randomized to treatment and received at least 1 dose of study medication.||participants|||Number
641428|NCT02310750|Primary|Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Oral Temperature at Day 28||Baseline, 16 hours post-dose on Day 28|FAS included all participants who were randomized to treatment and received at least 1 dose of study medication. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||degrees celsius||Standard Deviation|Mean
641429|NCT02310750|Primary|Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Oral Temperature at Day 10||Baseline, 16 hours post-dose on Day 10|FAS included all participants who were randomized to treatment and received at least 1 dose of study medication. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||degree celsius||Standard Deviation|Mean
641430|NCT02310750|Primary|Single Ascending Dose (SAD) Cohort: Change From Baseline in Oral Temperature at Day 1||Baseline, 24 hours post-dose on Day 1|FAS included all participants who were randomized to treatment and received at least 1 dose of study medication.||degree celsius||Standard Deviation|Mean
641431|NCT02310750|Primary|Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Pulse Rate at Day 28||Baseline, 16 hours post-dose on Day 28|FAS included all participants who were randomized to treatment and received at least 1 dose of study medication. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||bpm||Standard Deviation|Mean
641432|NCT02310750|Primary|Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Pulse Rate at Day 10||Baseline, 16 hours post-dose on Day 10|FAS included all participants who were randomized to treatment and received at least 1 dose of study medication. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||bpm||Standard Deviation|Mean
641433|NCT02310750|Primary|Single Ascending Dose (SAD) Cohort: Change From Baseline in Pulse Rate at Day 1||Baseline, 24 hours post-dose on Day 1|FAS included all participants who were randomized to treatment and received at least 1 dose of study medication.||beats per minute (bpm)||Standard Deviation|Mean
641434|NCT02310750|Primary|Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Blood Pressure at Day 28||Baseline, 16 hours post-dose on Day 28|FAS included all participants who were randomized to treatment and received at least 1 dose of study medication. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||mmHg||Standard Deviation|Mean
641435|NCT02310750|Primary|Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Blood Pressure at Day 10||Baseline, 16 hours post-dose on Day 10|FAS included all participants who were randomized to treatment and received at least 1 dose of study medication. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||mmHg||Standard Deviation|Mean
641436|NCT02310750|Primary|Single Ascending Dose (SAD) Cohort: Change From Baseline in Blood Pressure at Day 1||Baseline, 24 hours post-dose on Day 1|Full analysis set (FAS) included all participants who were randomized to treatment and received at least 1 dose of study medication.||millimeter of mercury (mmHg)||Standard Deviation|Mean
641437|NCT02310646|Other Pre-specified|Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2|Comparison of contribution of each product attribute in the stated preference between trial treatments (foam and gel)|Baseline to Week 2|In total 103 preferred foam and 105 preferred gel. 4 subjects ...||percentage of subjects|||Number
641438|NCT02310646|Other Pre-specified|Within Subject Difference in Response to Vehicle Preference Measure (VPM) Items Between Trial Treatments|The VPM questionnaire was analysed the same way as the TPUQ. Numeric scores were calculated by assigning the following values to each response category: -3 = Extremely unappealing, -2 = Moderately unappealing, -1 = Slightly unappealing, 0 = Neutral, 1 = Slightly appealing, 2 = Moderately appealing, 3 = Extremely appealing. A summary score was defined as the sum of all questions and could range from -21 to 21.|At Week 1 and Week 2|||units on a scale||Standard Deviation|Mean
641439|NCT02310646|Other Pre-specified|Responses to Comparison to Last Topical Treatment Questionnaire (CLTT) for Each of the Two Trial Treatments (Foam or Gel)|"Subjects in both arms (foam-gel; gel-foam) indicated whether they preferred latest topical treatment, LEO 90100 aerosol foam, Daivobet® gel, or did not have any preference.
The subjects compared the trial treatment used the previous week with the latest topical treatment (used within 3 months prior to baseline; CLTT analysis set). Each item was scored with either ‘prefer latest treatment’, ‘no preference’, or ‘prefer trial medication (foam or gel)’. A subject could prefer both study treatments over the latest topical treatment. The percentage is given for the number of subjects preferring foam and number of subjects preferring gel."|At Week 1 and Week 2|CLTT analysis set was defined by including all randomised subjects who had used topical anti-psoriatic medication on the treatment area (trunk and/or limbs) within 3 months prior to Baseline.||percentage of subjects|||Number
641440|NCT02310646|Other Pre-specified|Within Subject Difference in Response to TPUQ Between the Last Topical Anti-psoriatic Treatment and Each of the 2 Trial Treatments|"The TPUQ tool was used to evaluate the subject’s latest topical treatment at Baseline (used within 3 months prior to baseline). TPUQ assessments of trial treatments at Week 1 and Week 2.
Each response category (item 1 to 25) was assigned a numeric score from-2=strongly disagree to 2=strongly agree. For item 26 the assigned scores were from -2=very dissatisfied to 2=very satisfied.
Summary scores were calculated by summing numeric scores for items under each domain, i.e., application (items 1-9; score range -18 to +18), formulation (items 10-18; score range -18 to +18), container (items 19-22; score range -8 to +8), and satisfaction (items 23-25; score range -6 to +6).
For each subject and each item, the latest topical treatment score was compared with each study treatment by calculating the difference between the scores, i.e., by subtracting the latest topical treatment score from each study medication score. The higher score signifies higher preference in that domain."|Baseline to Week 2|||units on a scale||Standard Deviation|Mean
641441|NCT02310646|Other Pre-specified|Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments|"Each response category (item 1 to 25) was assigned a numeric score (-2=strongly disagree, -1=slightly disagree, 0=neither agree nor disagree, 1=slightly agree, 2=strongly agree). For item 26, the assigned score were from -2=very dissatisfied to 2=very satisfied.
Summary scores were calculated by summing numeric scores for items under each domain, i.e., application (items 1-9; score range -18 to +18), formulation (items 10-18; score range -18 to +18), container (items 19-22; score range -8 to +8), and satisfaction (items 23-25; score range -6 to +6). Positive scores indicate agreement with domains’ items.
A total TPUQ summary score (item 1-25; score range -50 to +50) was also calculated. The summary scores were analysed in the same way as the individual questions. The higher score signifies higher preference in that domain."|2 weeks|||units on a scale||Standard Deviation|Mean
641442|NCT02310646|Primary|Overall Treatment Preference by Subject's Preference Assessment (SPA) at Week 2 and Association With Baseline Characteristics|"The SPA questionnaire was completed at Week 2 and consisted of 2 parts:
(i) the subject indicated if they preferred LEO 90100 foam or Daivobet® gel based on their experience using these products for 1 week each during the 2-weeks treatment period; (ii) the subject indicated how much each of the 22 items under the application, formulation, and container domains contributed to their overall decision of which product they preferred. This part of the SPA tool used a 4-point scale ranging from ‘very important factor’ to ‘not at all important factor’.
The statistical significance of each of the following 7 baseline characteristics (gender, age, disease severity, distribution, plaque size, skin thickness, onset) was tested in a 2-factor logistic regression model with treatment sequence and each baseline characteristic as factors.
Results of multiple regression analyses are provided in the Clinical Study Report which can be found on the LEO Pharma website."|2 weeks|||percentage of subjects|||Number
641443|NCT02310581|Secondary|Percentage of Participants Who Used Rescue Medication for Pain|The percentage of participants who needed to take an alternate medication for pain relief during the study.|From Time 0 (first dose of study drug) up to Day 9|ITT Population included all participants who were randomized.||percentage of participants|||Number
641444|NCT02310581|Secondary|NRS SPID Over 0 to 24 Hours After Time 0 (NRS SPID-24)|Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug) and at multiple time points up to 24 hours after Time 0 (administration of first dose of study drug). Pain intensity difference is calculated by subtracting the pain intensity at each time point from the pain intensity at Time 0. The SPID scores are the sum of the differences at each time point multiplied by the duration in hours since the previous time point. Positive numbers indicate a reduction in pain [maximum (max)=10 at each time point] and negative numbers indicate an increase in pain [minimum (min)=-10 at each time point]. The overall min and max are -10 and 10 times the number of hours specified; SPID-24 range is -240 to 240. The NRS SPID-24 was analyzed using an analysis of covariance (ANCOVA) model, which included treatment and site as main effects and Baseline pain intensity as the covariate.|Baseline and 0 to 24 hours after Time 0|ITT Population included all participants who were randomized.||units on a scale||Standard Error|Least Squares Mean
641445|NCT02310581|Secondary|NRS SPID Over 0 to 8 Hours After Time 0 (NRS SPID-8)|Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug) and at multiple time points up to 8 hours after Time 0 (administration of first dose of study drug). Pain intensity difference is calculated by subtracting the pain intensity at each time point from the pain intensity at Time 0. The SPID scores are the sum of the differences at each time point multiplied by the duration in hours since the previous time point. Positive numbers indicate a reduction in pain [maximum (max)=10 at each time point] and negative numbers indicate an increase in pain [minimum (min)=-10 at each time point]. The overall min and max are -10 and 10 times the number of hours specified; SPID-8 range is -80 to 80. The NRS SPID-8 was analyzed using an analysis of covariance (ANCOVA) model, which included treatment and site as main effects and Baseline pain intensity as the covariate.|Baseline and 0 to 8 hours after Time 0|ITT Population included all randomized participants.||units on a scale||Standard Error|Least Squares Mean
641446|NCT02310581|Secondary|NRS SPID Over 0 to 4 Hours After Time 0 (NRS SPID-4)|Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug) and at multiple time points up to 4 hours after Time 0 (administration of first dose of study drug). Pain intensity difference is calculated by subtracting the pain intensity at each time point from the pain intensity at Time 0. The SPID scores are the sum of the differences at each time point multiplied by the duration in hours since the previous time point. Positive numbers indicate a reduction in pain [maximum (max)=10 at each time point] and negative numbers indicate an increase in pain [minimum (min)=-10 at each time point]. The overall min and max are -10 and 10 times the number of hours specified; SPID-4 range is -40 to 40. The NRS SPID-4 was analyzed using an analysis of covariance (ANCOVA) model, which included treatment and site as main effects and Baseline pain intensity as the covariate.|Baseline and 0 to 4 hours after Time 0|ITT Population included all participants who were randomized.||units on a scale||Standard Error|Least Squares Mean
641479|NCT02308787|Other Pre-specified|Average Inlet Flow Rate||Participants were followed for the duration of the procedure and an average of 2.5 hours after the procedure|Data were collected for 12 subjects who underwent a total of 20 PLTD procedures at 2 European sites.||mL/min|Participants|Standard Deviation|Mean
641447|NCT02310581|Secondary|NRS Mean Pain Intensity Score at 4, 8, 24 and 48 Hours After Time 0|Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug administration) and at multiple time points up to 48 hours after Time 0 (time of administration of the first dose of study drug). A lower value indicates improvement in pain.|4, 8, 24 and 48 hours after Time 0|All randomized participants from the ITT Population with data available at each timepoint.||units on a scale||Standard Deviation|Mean
641448|NCT02310581|Secondary|NRS Mean Pain Intensity Difference (PID) at 4, 8, 24 and 48 Hours After Time 0|Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug administration) and at multiple time points up to 48 hours after Time 0 (time of administration of the first dose of study drug). NRS PID is defined as the difference in pain at each scheduled timepoint relative to Baseline (PID=pain intensity at baseline – pain intensity at time point). A higher value of NRS PID score indicates a higher decrease in pain from Baseline.|Baseline and 4, 8, 24 and 48 hours after Time 0|All randomized participants from the ITT Population with data available at each timepoint.||units on a scale||Standard Deviation|Mean
641449|NCT02310581|Primary|Numeric Rating Scale (NRS) Summed Pain Intensity Difference (SPID) Over 0 to 48 Hours After Time 0 (NRS SPID-48)|Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug) and at multiple time points up to 48 hours after Time 0 (administration of first dose of study drug). Pain intensity difference is calculated by subtracting the pain intensity at each time point from the pain intensity at Time 0. The SPID scores are the sum of the differences at each time point multiplied by the duration in hours since the previous time point. Positive numbers indicate a reduction in pain [maximum (max)=10 at each time point] and negative numbers indicate an increase in pain [minimum (min)=-10 at each time point]. The overall min and max are -10 and 10 times the number of hours specified; SPID-48 range is -480 to 480. The NRS SPID-48 was analyzed using an analysis of covariance (ANCOVA) model, which included treatment and site as main effects and Baseline pain intensity as the covariate.|Baseline and 0 to 48 hours after Time 0|All randomized participants from the Intent-to-Treat (ITT) Population.||units on a scale||Standard Error|Least Squares Mean
641450|NCT02310568|Secondary|Percentage of Participants With Remission of Total Hamilton Anxiety Rating Scale (HAM-A) Scores|Percentage of participants with HAM-A total score less than or equal to 7 in the last week of the Stage (Week 4 in Stage 1, Week 8 in Stage 2). The HAM-A scale was a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety.|Stage 1: Week 1 up to Week 4 and Stage 2: Week 5 up to Week 8|Full analysis set for Stage 1 was defined as all participants randomized and who had received at least 1 dose of randomized treatment. The Stage 2 placebo non-responder set was defined as the subset of subjects in the Stage 2 placebo set who had both a <50% reduction in HAM-A between Stage 1 baseline and Week 4, and HAM-A value of >= 16 at Week 4.||percentage of participants|||Number
641451|NCT02310568|Secondary|Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Somatic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8|The HAM-A scale was a clinician interview-administered scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Somatic subscale of the HAM-A was the sum of 7 items. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 28 (very severe), where lower scores indicates less anxiety.|Stage 1 (S1): Baseline (Day 1), Week 1 (W1), 2 (W2), 3 (W3), 4 (W4) and Stage 2 (S2): Baseline (Day 28), Week 5 (W5), 6 (W6), 7 (W7), 8 (W8)|Full analysis set for Stage 1 and Placebo Non-Responder set for Stage 2. Here, 'N' signifies those participants who were evaluable for this outcome measure.||units on a scale||Standard Deviation|Mean
641452|NCT02310568|Secondary|Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Psychic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8|The HAM-A scale was a clinician interview-administered scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Psychic subscale of the HAM-A was the sum of 7 items. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 28 (very severe), where lower scores indicates less anxiety.|Stage 1 (S1): Baseline (Day 1), Week 1 (W1), 2 (W2), 3 (W3), 4 (W4) and Stage 2 (S2): Baseline (Day 28), Week 5 (W5), 6 (W6), 7 (W7), 8 (W8)|Full analysis set for Stage 1 and Placebo Non-Responder set for Stage 2. Here, 'N' signifies those participants who were evaluable for this outcome measure.||units on a scale||Standard Deviation|Mean
641453|NCT02310568|Secondary|Plasma Concentration Versus Time Summary of PF-06372865: Stage 2|Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLOQ =0.0100 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) =0.|Pre-dose (0 hour), 2, 4, 10 hours post dose on Day 1 of Week 6, 7, 8|Placebo Non-Responder set for Stage 2. Participants who received PF-06372865 2.5 mg or PF-06372865 7.5 mg were evaluable for this measure. Here,‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||ng/mL||Standard Deviation|Mean
641454|NCT02310568|Secondary|Plasma Concentration Versus Time Summary of PF-06372865: Stage 1|Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLOQ =0.0100 nanogram per milliliter (ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) = 0.|Pre-dose (0 hour), 2, 4, 10 hours post dose on Day 1 of Week 2, 3, 4|Stage 1 full analysis set: All randomized participants who received at least 1 dose of study treatment. Participants who received PF-06372865 2.5 mg or PF-06372865 7.5 mg were evaluable for this measure. Here,‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||ng/mL||Standard Deviation|Mean
641480|NCT02308787|Other Pre-specified|Whole Blood Processed (mL)|Volume of patients blood processed during the apheresis procedure.|Post each Spectra Optia Apheresis Procedure|Data were collected for 12 subjects who underwent a total of 20 PLTD procedures at 2 European sites.||mL|Participants|Standard Deviation|Mean
648265|NCT02107014|Primary|Change in LIF From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].|||pg/mL||95% Confidence Interval|Median
641455|NCT02310568|Secondary|Change From Baseline in Clinical Global Impression -Severity (CGI-S) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2|The CGI-S consisted of a single 7-point rating score of illness severity, was completed by a clinician. Raters selected one response based on the following question, “Considering your total clinical experience with that particular population, how mentally ill was your participant at that time?” Scores were: 1 (normal, not ill at all), 2 (borderline mentally ill), 3 (mildly ill), 4 (moderately ill), 5 (markedly ill) 6 (severely ill) or 7 (among the most severely ill participants). Higher scores indicate more severity.|Stage 1 (S1): Baseline (Day 1), Week 1 (W1), 2 (W2), 3 (W3), 4 (W4) and Stage 2 (S2): Baseline (Day 28), Week 5 (W5), 6 (W6), 7 (W7), 8 (W8)|Full analysis set for Stage 1 and Placebo Non-Responder set for Stage 2. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.||units on a scale||Standard Deviation|Mean
641456|NCT02310568|Secondary|Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2|CGI-I was a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse) or 7 (very much worse) on the scale. Higher score indicated more affected. Change is equal to score at observation minus score at baseline.|Stage 1 (S1): Baseline (Day 1), Week 1 (W1), 2 (W2), 3 (W3), 4 (W4) and Stage 2 (S2): Baseline (Day 28), Week 5 (W5), 6 (W6), 7 (W7), 8 (W8)|Full analysis set for Stage 1 and Placebo Non-Responder set for Stage 2. Here, 'N' signifies those participants who were evaluable for this outcome measure.||units on a scale||Standard Deviation|Mean
641457|NCT02310568|Secondary|Percentage of Responders of Total Hamilton Anxiety Rating Scale (HAM-A): Stage 1 and Stage 2|A responder was defined as a participant with >= to 50 percent decrease in their total HAM-A score from baseline to the last week in the stage (Week 4 in Stage 1, Week 8 in Stage 2). The HAM-A scale was a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety. Percentage of responders of total HMA scale were reported.|Stage 1: Week 4, Stage 2: Week 8|Full analysis set for Stage 1 and Placebo Non-Responder set for Stage 2. Here, 'N' signifies those participants who were evaluable for this outcome measure.||percentage of participants|||Number
641458|NCT02310568|Secondary|Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 1, Week 2 and Week 3: Stage 1|The HAM-A scale was a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety.|Week 1, 2, 3|Stage 1 full analysis set: All randomized participants who received at least 1 dose of study treatment. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||units on a scale||Standard Error|Least Squares Mean
641459|NCT02310568|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores: Stage 1 and Stage 2|SDS was a copyrighted, three question instrument designed to assess functional impairment associated with mental disorders in three domains: work impairment, social impairment, and impairment of family life or home responsibilities. Disability scores were reported for each of the questions (subscale scores range from 0 to 10) and a total disability score was calculated as the sum of scores for each question (total scores range from 0 to 30). Higher scores reflect greater impairment.|Stage 1: Week 4, Stage 2: Week 8|Full analysis set for Stage 1 and Placebo Non-Responder set for Stage 2. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||units on a scale||Standard Error|Least Squares Mean
641460|NCT02310568|Secondary|Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores at Baseline: Stage 1 and Stage 2|SDS was a copyrighted, three question instrument designed to assess functional impairment associated with mental disorders in three domains: work impairment, social impairment, and impairment of family life or home responsibilities. Disability scores were reported for each of the questions (subscale scores range from 0 to 10) and a total disability score was calculated as the sum of scores for each question (total scores range from 0 to 30). Higher scores reflect greater impairment.|Stage 1: Baseline (Day 1 ), Stage 2: Baseline (Day 28)|Full analysis set for Stage 1 and Placebo Non-Responder set for Stage 2. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||units on a scale||Standard Deviation|Mean
641461|NCT02310568|Secondary|Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 5, Week 6, Week 7 and Week 8: Stage 2|The HAM-A scale was a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety.|Week 5, 6, 7, 8|Stage 2 placebo non-responder set: Subset of Stage 2 placebo set (participants who received placebo in Stage 1) < 50 % reduction in HAM-A during Stage 1 baseline, Week 4 and HAM-A value of >=16 at Week 4. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||units on a scale||Standard Error|Least Squares Mean
641462|NCT02310568|Primary|Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 4 During Stage 1 and at Week 8 During Stage 2|The HAM-A scale was a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety.|Stage 1: Week 4, Stage 2: Week 8|Full analysis set for Stage 1 and Placebo Non-Responder set for Stage 2. Here, 'N' signifies those participants who were evaluable for this outcome measure.||units on a scale||Standard Deviation|Mean
641481|NCT02308787|Other Pre-specified|Patient's WBC Count Post-depletion Procedure||Participants were followed for the duration of the procedure and an average of 2.5 hours after the procedure|Data were collected for 12 subjects who underwent a total of 20 PLTD procedures at 2 European sites.||cells x 10^9/L|Participants|Standard Deviation|Mean
641463|NCT02310568|Primary|Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 4: Stage 1|The HAM-A scale was a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety.|Week 4|Full analysis set for Stage 1 included all randomized participants who had received at least 1 dose of randomized treatment. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.||units on a scale||Standard Error|Least Squares Mean
641464|NCT02310568|Primary|Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Baseline: Stage 1 and 2|The HAM-A scale was a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety.|Stage 1: Baseline (Day 1 ), Stage 2: Baseline (Day 28)|Stage 1 full analysis set: All randomized participants who received at least 1 dose of study treatment. Stage 2 placebo non-responder set: Subset of Stage 2 placebo set (participants who received placebo in Stage 1) with less than (<) 50% reduction in HAM-A during Stage 1 baseline,Week 4 and HAM-A value of greater than or equal to (>=)16 at Week 4.||units on a scale||Standard Deviation|Mean
641465|NCT02310126|Primary|Overall Lens Handling Using the Contact Lens User Experience(CLUE) TM Questionnaire.|CLUE Overall Lens Handling is assessed using the Contact Lens User Experience (CLUE)TM questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD).|15 minutes post Contact Lens Insertion|The analysis population consist of subjects that completed all study visits without a major protocol deviation. The analysis was conducted for each lens and strata.||units on a scale||Standard Deviation|Mean
641466|NCT02309723|Primary|Likelihood of Recommending That Spouse Take Various Cognitive Deficit Disease Management Measures|Proportion of respondents who recommend that the patient's spouse take actions that would be appropriate if the patient has Alzheimer's disease, including: (1) discussion of advance care planning, (2) monitoring of patient's finances, (3) assessment of how compatible the patient's job is with his conditions, (4) the initiation of precautions to ensure the patient is properly taking his medications to manage hypertension and hyperlipidemia.|Online Survey - completion during the estimated 2-3 month field period|||participants|||Number
641467|NCT02309723|Primary|Likelihood of Recommending a Medication Indicated for Alzheimer's Disease|Proportion of respondents who recommend a medication indicated for the treatment of Alzheimer's Disease, including Acetylcholinesterase inhibitors, N-methyl-D-aspartate receptor antagonists, Typical antipsychotics – e.g., Chlorpromazine (Thorazine), Haloperidol (Haldol), Atypical antipsychotics – e.g., Clozapine (Clozaril), Risperidone (Risperdal), Antidepressant – e.g., Citalopram (Celexa), Venlafaxine (Effexor), Antianxiety agent – e.g. Benzodiazepines, Buspirone (Buspar).|Online Survey - completion during the estimated 2-3 month field period|||participants|||Number
641468|NCT02309723|Primary|Influence of the Neuroimaging Test on a Finding of Alzheimer's Disease as the Underlying Cause of the Mild Memory Loss|Proportion of respondents who identify Alzheimer's Disease as the sole or a contributing factor that is responsible for the patient's cognitive complaint.|Online Survey - completion during the estimated 2-3 month field period|||participants|||Number
641469|NCT02309294|Primary|Number of Subjects That Showed no Significant Irritation|Score of less than or equal to 1.2 on the Cumulative Irritation Test scale (0-5).|14 days|||participants|||Number
641470|NCT02309112|Secondary|Patient Adherence Rate to Yoga Intervention|% of patients who completed their yoga intervention|6 weeks|Male (n=4) and female (n=11) adult patients undergoing conventional treatment for cancer diagnosis in Vancouver, Canada||percentage of participants|||Number
641471|NCT02309112|Other Pre-specified|Patient's Health-related Quality of Life|Assessed via an online survey of a validated, cancer-specific survey instrument measuring health-related quality of life (QOL-CA/CS), (0 worst; 10 best possible). The QOL-CA/CS score was assessed pre and post yoga intervention.|6 weeks|Male (n=3) and female (n=9) adults undergoing conventional treatment for cancer diagnosis in Vancouver, Canada.||units on quality of life scale||Full Range|Mean
641472|NCT02309112|Other Pre-specified|Financial Cost of Delivering Yoga Intervention in a Clinical Setting|Calculation of the per participant cost of three types of yoga interventions (Group A, B and C). The financial data included cost of in-person instruction, cost of materials and time to design and implement intervention per participant in each yoga group.|10 weeks|Male (n=3) and female (n=10) adult patients undergoing conventional treatment for cancer diagnosis in Vancouver, Canada||dollars (USD)|||Number
641473|NCT02309112|Other Pre-specified|Patient Acceptability of Yoga Intervention|Amount of satisfaction for adult cancer patients assessed via Likert-scale surveys; on scale of 1 to 10, 1 being not satisfied; 10 being extremely satisfied (i.e higher number, better outcome).|6 weeks|Adult male (n=3) and female (n=9) cancer patients undergoing conventional treatment for cancer diagnosis in Vancouver, Canada||units on satisfaction scale||Full Range|Mean
641474|NCT02309112|Secondary|Patient Adherence to Yoga Intervention|Number of participants who completed their yoga intervention|6 weeks|Male (n=4) and female (n=11) adult patients undergoing conventional treatment for cancer diagnosis in Vancouver, Canada||participants|||Number
641475|NCT02309112|Primary|Feasibility of Patient Recruitment to Yoga Intervention|Number of participants eligible for randomization to yoga intervention during cancer treatment|10 weeks|Male (n=4) and female (n=11) adult patients undergoing conventional treatment in Vancouver, Canada for a cancer diagnosis; who have not participated in yoga the past month.||participants|||Number
641476|NCT02308787|Other Pre-specified|Total Blood Volume (TBV) Processed|The number of times the patient's total blood volume is processed during the apheresis procedure.|Post each Spectra Optia Apheresis Procedure|Data were collected for 12 subjects who underwent a total of 20 PLTD procedures at 2 European sites.||Number of TBVs processed|Participants|Standard Deviation|Mean
641477|NCT02308787|Other Pre-specified|Waste Bag Volume||Post each Spectra Optia Apheresis Procedure|Data were collected for 12 subjects who underwent a total of 20 PLTD procedures at 2 European sites.||mL|Participants|Standard Deviation|Mean
641483|NCT02308787|Other Pre-specified|Patient's Platelet Count Post-depletion Procedure||Participants were followed for the duration of the procedure and an average of 2.5 hours after the procedure|Data were collected for 12 subjects who underwent a total of 20 PLTD procedures at 2 European sites.||cells x 10^3/L|Participants|Standard Deviation|Mean
641484|NCT02308787|Other Pre-specified|Patient's Platelet Count Pre-depletion Procedure||Prior to each Spectra Optia Apheresis Procedure|Data were collected for 12 subjects who underwent a total of 20 PLTD procedures at 2 European sites.||cells x 10^3/L|Participants|Standard Deviation|Mean
641485|NCT02308787|Primary|Adverse Events||during the apheresis procedure (from the moment the patient is connected until he is disconnected from the device) and device or procedure related adverse events until discharge from Apheresis Unit (On average, half hour after end of procedure).|Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.||Number of subjects with at least 1 AE|||Number
641486|NCT02308787|Primary|Percent of Processed Platelets (PLT) Which Are Collected i.e. Collection Efficiency for Platelets Achieved by Spectra Optia.|(PLT/µL product x product volume) / ((PLTpre + PLTpost) / 2) x total processed blood volume)|on average this will be within 15 minutes after the end of the procedure|At Site 2, percent processed platelets could only be calculated for 1 procedure in Subject 214; no waste bag (depletion product) platelet counts were available for the other 9 procedures performed at Site 2.||% of processed platelets|Participants|Standard Deviation|Mean
641487|NCT02308787|Primary|Percent Change in Platelet (PLT) Count in Patient Blood Following Apheresis Procedure|(PLTpre - PLTpost) / PLTpre x 100%|on average this will be within 15 minutes after the end of the procedure|Data were collected for 12 subjects who underwent a total of 20 PLTD procedures at 2 European sites.||% change in PLT count in subject blood|Participants|Standard Deviation|Mean
641488|NCT02308748|Secondary|Change in Placebo Corrected Change From Baseline QTc Interval on the ECG Measured in Milliseconds When Moxifloxacin is Administered With Diltiazem at the Evening Dose Compared to When Moxifloxacin is Administered Alone at Afternoon Dose on Treatment Day.|Evening dose (moxifloxacin+diltiazem) versus afternoon dose (diltiazem alone).|5 weeks|All study participants that completed placebo, moxifloxacin and moxifloxacin + diltiazem||ms||95% Confidence Interval|Mean
641489|NCT02308748|Primary|Change in Placebo Corrected Change From Baseline QTc and J-Tpeakc Intervals on the ECG Measured in Milliseconds When Dofetilide is Administered With Mexiletine or Lidocaine Compared to When Dofetilide is Administered Alone at Evening Dose on Treatment Day|After 3rd dose of mexiletine or lidocaine (evening dose) on treatment day when combined with dofetilide to evening dose on dofetilide alone day.|5 weeks|All study participants that completed placebo and dofetilide alone as well as dofetilide + mexiletine and/or dofetilide + lidocaine||ms||95% Confidence Interval|Mean
641490|NCT02308371|Secondary|Number of Days in the PICU|Number of days for admission pediatric critical care unit (admission during which subject was enrolled into the study)|From pediatric ICU admission to pediatric ICU discharge (up to 149 days)|||days||Standard Deviation|Mean
641491|NCT02308371|Secondary|Number of Days on Ventilatory Support|Number of days subject was on ventilatory support (during time of subject enrollment) to the pediatric critical care unit. This included subjects that were intubated or was on a ventilator with a tracheotomy|From pediatric ICU admission to pediatric ICU discharge (up to 149 days)|||days||Standard Deviation|Mean
641492|NCT02308371|Secondary|Number of Hours on Vasopressors|Hours that a subject remained intubated during pediatric intensive care admission during subject recruitment|From pediatric ICU admission to pediatric ICU discharge (up to 149 days)|||hours||Standard Deviation|Mean
641493|NCT02308371|Primary|Total Fluid Bolused|Total fluid bolused within 48 hours after enrollment.|48 hours after enrollment|||ml/kg||Standard Deviation|Mean
641494|NCT02308371|Primary|Total Fluid (ml/kg/Day) Given|Total fluid (ml/kg/day) given during the first 48 hours of enrollment|First 48 hours after enrollment|||ml/kg/day||Standard Deviation|Mean
641495|NCT02308124|Secondary|Changes in Health-related Quality of Life|"changes in Short Form (36) Health Survey version 2 (SF-36v2) mental component summary scale (MCS)
SF-36v2 measures eight HRQOL domains (physical functioning, role limitation caused by physical problems, bodily pain, general health, vitality, social functioning, role limitation caused by emotional problems, and mental health) summarized into two summary scales that are normalized to the population (mean=50, standard deviation=10): the physical component summary scale (PCS) and the mental component summary scale (MCS).20 Better HRQOL is reflected by higher SF-36v2 scores."|changes at 3 months after treatment|At 3 months after treatment, 65 patients were evaluated (Midodrine only; 23, Pyridostigmine only; 21, Midodrine + Pyridostigmine; 21). 22 additional patients missed visit (Midodrine only; 6, Pyridostigmine only; 8, Midodrine + Pyridostigmine; 8)||points||Standard Deviation|Mean
641496|NCT02308124|Secondary|Changes in Health-related Quality of Life|"changes in Short Form (36) Health Survey version 2 (SF-36v2) physical component summary scale (PCS) compared to the baseline
SF-36v2 measures eight HRQOL domains (physical functioning, role limitation caused by physical problems, bodily pain, general health, vitality, social functioning, role limitation caused by emotional problems, and mental health) summarized into two summary scales that are normalized to the population (mean=50, standard deviation=10): the physical component summary scale (PCS) and the mental component summary scale (MCS).20 Better HRQOL is reflected by higher SF-36v2 scores."|changes at 3 months after treatment|At 3 months after treatment, 65 patients were evaluated (Midodrine only; 23, Pyridostigmine only; 21, Midodrine + Pyridostigmine; 21). 22 additional patients missed visit (Midodrine only; 6, Pyridostigmine only; 8, Midodrine + Pyridostigmine; 8)||points||Standard Deviation|Mean
641497|NCT02308124|Secondary|Change of the Depression Score (Beck Depression Inventory-II )|"Change of the depression score after 3-month medical treatment compared to initial results.
21 multiple-choice questions, each of which can be scored from 0 to 3. Higher score represent higher degree of depression.
Score Normal; 0-13, Mild depression; 14-19, Moderate depression; 20-28, Severe depression; 29-63"|after 3-month medical treatment.|At 3 months after treatment, 65 patients were evaluated (Midodrine only; 23, Pyridostigmine only; 21, Midodrine + Pyridostigmine; 21). 22 additional patients missed visit (Midodrine only; 6, Pyridostigmine only; 8, Midodrine + Pyridostigmine; 8)||points||Standard Deviation|Mean
641519|NCT02307526|Primary|Diastolic Blood Pressure||Average diastolic blood pressure of 10 minutes supine rest before pyridostigmine and after 45 minutes at 45 degrees after pyridostigmine administration compared to 10 minutes supine rest before tilt and at 45 degrees during no-drug head-up tilt maneuver.|||mm Hg||Standard Deviation|Mean
641498|NCT02308124|Secondary|Change of the Orthostatic Hypotension Associated Symptom Questionnaire (OH Questionnaire (OHQ)).|"Change of the OH associated symptom survey result after 3-month medical treatment compared to initial results.
OHQ questionnaire has two components: the OH daily activity scale (OHDAS), which contains 4 items measuring the impact of OH on daily activities, and the OH symptom assessment (OHSA), which contains 6 items measuring the symptoms of OH (dizziness/light headedness, vision disturbance, weakness, fatigue, trouble concentrating, and head/neck discomfort).This questionnaire reflects the severity of OH-related symptoms on a 10-point scale, with 0 indicating the absence of a symptom and 10 indicating maximal severity.
** OHQ total score minimal 0 ~ maximal 100"|after 3-month medical treatment.|At 3 months after treatment, 65 patients were evaluated (Midodrine only; 23, Pyridostigmine only; 21, Midodrine + Pyridostigmine; 21). 22 additional patients missed visit (Midodrine only; 6, Pyridostigmine only; 8, Midodrine + Pyridostigmine; 8)||points||Standard Deviation|Mean
641499|NCT02308124|Primary|Change in Orthostatic BP Drop|Change of orthostatic SBP and DBP drop after 3-month medical treatment compared to initial results.|after 3-month medical treatment|At 3 months after treatment, 65 patients were evaluated (Midodrine only; 23, Pyridostigmine only; 21, Midodrine + Pyridostigmine; 21). 22 additional patients missed visit (Midodrine only; 6, Pyridostigmine only; 8, Midodrine + Pyridostigmine; 8)||mmHg||Standard Deviation|Mean
641500|NCT02307838|Secondary|Correlation Coeffcients Between FTY Treatment Duration and Disability Progression Parameters|The correlation between FTY treatment duration and disability progression outcomes was assessed. The number presented in the table is the Pearson correlation coefficient, r.|10 years|The FAS was considered for the analysis. Only participants who had 10 year correlation measurements were analyzed. The FAS included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or MRI within study FTY720D2201.||Pearson correlation coeffcient|||Number
641501|NCT02307838|Secondary|Percentage Brain Volume Change (PBVC)|PVBC was assessed by MRI. A negative change from baseline indicates improvement.|baseline from core study (CFTY720D2201 (NCT00333138)), 10 years|The FAS was considered for the analysis. Only participants with both baseline and 10 year measurements were analyzed. The FAS included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or MRI within study FTY720D2201.||Percent change||Standard Deviation|Mean
641502|NCT02307838|Secondary|Change From Baseline in Third Ventricle Diameter|Third ventricle diameter was assessed by MRI. A negative change from baseline indicates improvement.|baseline from core study (CFTY720D2201 (NCT00333138)), 10 years|The FAS was considered for analysis. Only participants who had both baseline and 10 year measurements were analyzed. The FAS included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or MRI within study FTY720D2201.||mm||Standard Deviation|Mean
641503|NCT02307838|Secondary|Third Ventricle Diameter|Third ventricle diameter was assessed by MRI.|10 years|The FAS was considered for the analysis. Only participants with 10 year measurements were analyzed. The FAS included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or MRI within study FTY720D2201.||mm||Standard Deviation|Mean
641504|NCT02307838|Secondary|Change From Baseline in Total Volume of T2 Lesion|Total volume in T2 lesion was assessed by magnetic resonance imaging (MRI). A negative change from baseline indicates improvement.|baseline from core study (CFTY720D2201 (NCT00333138)), 10 years|The FAS was considered for the analysis. Only participants from the FAS who had both baseline and 10 years measurements were included in the analysis. The FAS included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or MRI within study FTY720D2201.||mm^3||Standard Deviation|Mean
641505|NCT02307838|Secondary|Total Volume in T2 Lesion|Total volume in T2 lesion was assessed by magnetic resonance imaging (MRI).|10 years|The FAS was considered for the analysis. Only participants with measurements at 10 years were included in the analysis. The FAS included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or MRI within study FTY720D2201.||mm^3||Standard Deviation|Mean
641506|NCT02307838|Secondary|Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Z Score|MSFC is a composite measure encompassing information from the nine-hole peg test (arm dimension), timed 25 foot walk (leg dimension) and PASAT. The MSFC composite Z score was calculated as follows: (1) the average scores from the four trials on the 9-HPT (the two trials for each hand were averaged, converted to the reciprocals of the mean times for each hand and then the two reciprocals were averaged); (2) the average scores of two 25-Foot Timed Walk trials; (3) the number correct from the PASAT-3. The MSFC is based on the concept that scores for these three dimensions—arm, leg, and cognitive function are combined to create a single score (the MSFC) that can be used to detect change over time in a group of multiple sclerosis patients. This was done by creating Z-scores for each component of the MSFC, and averaging them to create an overall composite Z score.|baseline from core study (CFTY720D2201 (NCT00333138)), 10 years|The FAS was considered for the analysis. Only participants with both baseline measurements for each MSFC component and 10 year measurements were analyzed. The FAS included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or MRI within study FTY720D2201.||Z score||Standard Deviation|Mean
641507|NCT02307838|Secondary|Change From Baseline in MSFC Component: Timed 25-foot Walk Test Score|The Timed 25-Foot Walk is a quantitative measure of lower extremity function. The patient is directed to one end of a clearly marked 25-foot (7.62 m) course and is instructed to walk 25 feet (7.62 meter) as quickly as possible, but safely. The task is immediately administered again by having the patient walk back the same distance. Patients may use assistive devices when doing this task. The test scores were the time in seconds it took to walk the 25 feet. A negative change from baseline indicates improvement.|baseline from core study (CFTY720D2201 (NCT00333138)), 10 years|The FAS was considered for the analysis. Only participants with both baseline and 10 year measurements were analyzed. The FAS included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or magnetic resonance imaging (MRI) within study FTY720D2201.||score on a scale||Standard Deviation|Mean
641520|NCT02307526|Primary|Systolic Blood Pressure||Average systolic blood pressure of 10 minutes supine rest before pyridostigmine and after 45 minutes at 45 degrees after pyridostigmine administration compared to 10 minutes supine rest before tilt and at 45 degrees during no-drug head-up tilt maneuver.|||mm Hg||Standard Deviation|Mean
641508|NCT02307838|Secondary|Change From Baseline in MSFC Component: Paced Auditory Serial Addition Test (PASAT) Score|The PASAT is a measure of cognitive function that specifically assesses auditory information processing speed and flexibility, as well as calculation ability. The PASAT is the last measure administered at each visit. It is presented on audio compact disc (CD) to control the rate of stimulus presentation. Single digits are presented every 3 seconds and the patient must add each new digit to the one immediately prior to it. The test result is the number of correct sums given (out of 60 possible). A positive change from baseline indicates improvement.|baseline from core study (CFTY720D2201 (NCT00333138)), 10 years|The FAS was considered for the analysis. Only participants with both baseline and 10 year measurements were analyzed. The FAS included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or magnetic resonance imaging (MRI) within study FTY720D2201.||score on a scale||Standard Deviation|Mean
641509|NCT02307838|Secondary|Change From Baseline in Multiple Sclerosis Fuctional Composite (MSFC) Component: Nine Hole Peg Test (9-HPT)|The 9-HPT is a quantitative measure of upper extremity (arm and hand) function. Both the dominant and non-dominant hands are tested twice (two consecutive trials of the dominant hand, followed immediately by two consecutive trials of the non-dominant hand). The time limit per trial is 300 seconds. The right and left hand scores were the time in seconds it took to insert and remove 9 pegs ((the average scores from the four trials on the 9-HPT (the two trials for each hand are averaged, converted to the reciprocals of the mean times for each hand and then the two reciprocals are averaged)). A negative change from baseline indicates improvement.|baseline from core study, CFTY720D2201 (NCT00333138), 10 years|The full analysis set (FAS) included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or magnetic resonance imaging (MRI) within study FTY720D2201.||seconds||Standard Deviation|Mean
641510|NCT02307838|Secondary|Percentage of Participants With First Use of a Wheelchair|First use of a wheelchair was considered from EDSS 7.0 for participants having started FTY720D2201 (NCT00333138) with an EDSS score below 7.0.|10 years|The full analysis set (FAS) included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or magnetic resonance imaging (MRI) within study FTY720D2201.||Percentage of participants|||Number
641511|NCT02307838|Secondary|Percentage of Participants With First Use of an Ambulatory Device|First use of an ambulatory device was considered from EDSS 6.0 for participants having started FTY720D2201 (NCT00333138) with an EDSS score below 6.0.|10 years|The FAS was considered for the analysis. Only participants with evaluable data were included in the analysis. The FAS included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or magnetic resonance imaging (MRI) within study FTY720D2201.||Percentage of participants|||Number
641512|NCT02307838|Secondary|Number of Participants Classified as Secondary Progressive MS (SPMS)|SPMS follows an initial relapsing-remitting course. Most people who are diagnosed with relapsing-remitting multiple sclerosis (RRMS) will eventually transition to a secondary progressive course in which there is a progressive worsening of neurologic function (accumulation of disability) over time. Participants who were classified as SPMS were assessed.|10 years|The full analysis set (FAS) included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or magnetic resonance imaging (MRI) within study FTY720D2201.||Participants|||Number
641513|NCT02307838|Secondary|Number of Participants Not Using a Wheelchair or Being Bedridden|The number of participants not using a wheelchair or being bedridden was assessed.|10 years|The FAS included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or magnetic resonance imaging (MRI) within study FTY720D2201.||Participants|||Number
641514|NCT02307838|Secondary|Number of Participants With EDSS <4 or <6|EDSS is a scale for assessing neurologic impairment in MS. It consists of eight functional systems (FS) which are used to derive the EDSS steps (score) ranging from 0 (normal) to 10 (death due to MS). The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions. Based on the assessment of each FS, the participant's score is determined between 0 to 10. A positive change from baseline indicates improvement.|10 years|The FAS included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or magnetic resonance imaging (MRI) within study FTY720D2201.||Participants|||Number
641515|NCT02307838|Secondary|Number of Participants With Disability Progression|Disability progression is defined as: 1.5-point increase from baseline in participants with baseline EDSS score = 0.0; OR 1-point increase in EDSS from baseline in participants with baseline EDSS score of 1.0 to 5.0 inclusive; OR 0.5-point increase in EDSS from baseline in participants with baseline EDSS score >5.0.|10 Years|The FAS included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or magnetic resonance imaging (MRI) within study FTY720D2201.||Participants|||Number
641516|NCT02307838|Primary|Change From Baseline (BL) in Expanded Disability Status Scale (EDSS)|EDSS is a scale for assessing neurologic impairment in MS. It consists of eight functional systems (FS) which are used to derive the EDSS steps (score) ranging from 0 (normal) to 10 (death due to MS). The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions. Based on the assessment of each FS, the participant's score is determined between 0 to 10. A negative change from baseline indicates improvement.|baseline from core study (CFTY720D2201 (NCT00333138)), 10 years|The full analysis set (FAS) included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or magnetic resonance imaging (MRI) within study FTY720D2201.||score on a scale||Standard Error|Least Squares Mean
641517|NCT02307552|Primary|Measure Novel Transurethral Ultrasound Signatures to Detect Prostate Cancer|The primary objective of this Institutional Review Board -controlled study is to determine if Trans urethral ultrasound can be used to identify prostate cancer, thus avoiding prostate needle biopsies for diagnosis|one year|Data were not collected because the study was discontinued due to lack of feasibility and negative results.|||||
641518|NCT02307526|Primary|Heart Rate||Average heart rate of 10 minutes supine rest before pyridostigmine and after 45 minutes at 45 degrees following pyridostigmine administration compared to 10 minutes supine rest before tilt and at 45 degrees during no-drug head-up tilt maneuver.|||bpm||Standard Deviation|Mean
641521|NCT02307318|Secondary|Incidence of Hematoma and/or Ecchymosis|Number of patients who experience hematoma (bruising) and/or ecchymosis (discoloration of the skin caused by bleeding underneath) at the access site as measured by observation just prior to discharge.|Day1|||Participants|||Count of Participants
641522|NCT02307318|Secondary|Changes in Circulation, Movement and Sensation|Number of patients who experience changes in circulation, movement and sensation in the hand and wrist of the access site as measured by standard of care nursing assessments.|Day1|||Participants|||Count of Participants
641523|NCT02307318|Primary|Incidence of Thrombosis|Number of patients who experience thrombosis (blood clot) at the access site as measured by ultrasound between 4 hours and 24 hours post-procedure.|4 hours post-surgery|||Participants|||Count of Participants
641524|NCT02307318|Primary|Incidence of Arterial Bleeding|Number of patients who experience arterial bleeding after use of the Softseal hemostatic device and manual compression at the transradial access site as measured by observation.|Day1|||Participants|||Count of Participants
641525|NCT02307266|Primary|Mean Rate of Adherence, as Assessed by Medical Event Monitoring System (MEMS)|"To prevent bias, treatment adherence was assessed without subject’s knowledge using a Medication Event Monitoring System (MEMS). The treatment was placed in a container fitted with a MEMS cap which recorded the time/date every time it was opened and/or closed. A day with at least one opening was considered a day the subject was adherent. Mean rate of adherence in % corresponds to the number of days the subject was adherent dividided by the total number of days of the study (84 days) times 100.
Analysis was performed on the worst-case population: Missing data were considered as non-adherence."|week 12|Only subjects with usable MEMS data were analyzed, therefore the number of subjects in the analysis population is not the full population.||percentage of adherence||Standard Deviation|Mean
641526|NCT02307188|Primary|Atrial Fibrillation Dominant Frequency|Electrogram signal analysis will be performed to assess the dominant frequency of the atrial fibrillation electrograms collected by this catheter. These values will be correlated to patient outcomes.|1 year|Because the quality of intracardiac electrogram data for the one patient to complete the study was not sufficient for analysis, this outcome measure was not analyzed.|||||
641527|NCT02307123|Secondary|Glasgow Outcome Score (GOS)|GOS 1 = Death GOS 2 = Poor neurological outcome GOS 3 = Good neurological outcome Modified from the original 5 - step classification.|1 year|||percentage of good neurological outcome|||Number
641528|NCT02307123|Primary|Mortality||1 year|||percentage of one year mortality|||Number
641529|NCT02306928|Primary|50% fT>4xMIC: Free Piperacillin Concentration Maintained at a Level Fourfold the MIC for at Least 50% of the Dosing Interval.|The piperacillin plasma concentration-time profiles were best described by a two-compartment model. Each individual model predicted T>MIC was compared to clinical breakpoint MIC for P.aeruginosa (16 mg/L). The number of patients who achieved the pre-defined PK/PD target were reported.|Participants were followed up to the third dosing interval after initiation of piperacillin/tazobactam. An average of 24 hours.|||participants|||Number
641530|NCT02306928|Secondary|Trough Piperacillin Plasma Concentration (Cmin)|Trough plasma concentration (Cmin) was predicted for each individual based on the final model fit.|Participants were followed up to the third dosing interval after initiation of piperacillin/tazobactam. An average of 24 hours.|||mg/L||Inter-Quartile Range|Median
641531|NCT02306928|Secondary|The Area Under the Plasma-concentration Time Curve Concentration-time Curve From 0-8 Hours After the Studied Dose (AUC 0-8)|Area under the free plasma concentration-time curve (fAUC0-8) was predicted for each individual based on the final model fit.|Participants were followed up to the third dosing interval after initiation of piperacillin/tazobactam. An average of 24 hours.|||mg.hr/L||Inter-Quartile Range|Median
641532|NCT02306928|Secondary|The Maximum Concentration of Piperacillin (Cmax)|Maximum plasma concentration was predicted for each individual based on the final model fit.|Participants were followed up to the third dosing interval after initiation of piperacillin/tazobactam. An average of 24 hours.|||mg/L||Inter-Quartile Range|Median
641533|NCT02306928|Primary|100% f T>MIC: Free Piperacillin Concentration Maintained Above the MIC Throughout the Dosing Interval.|The piperacillin plasma concentration-time profiles were best described by a two-compartment model. Each individual model predicted T>MIC was compared to clinical breakpoint MIC for P.aeruginosa (16 mg/L). The number of patients who achieved the pre-defined PK/PD target were reported.|Participants were followed up to the third dosing interval after initiation of piperacillin/tazobactam. An average of 24 hours.|||participants|||Number
641534|NCT02306759|Secondary|ED Length of Stay (Minutes)|ED Length of stay (minutes) throughout study period|throughout study completion|||minutes||Standard Deviation|Mean
641535|NCT02306759|Secondary|Mean Consumption of Rescue Analgesia||at designated intervals during study period (0, 15, 30, 45, 60, 75, 90, 105, 120 minutes)|||milligrams||Standard Deviation|Mean
641536|NCT02306759|Secondary|Patient Satisfaction of Pain Control Based on a Likert Scale|Patient satisfaction of pain control based on a Likert Scale at the end of study completion, an average of 90 minutes. Scores reported out of scale of 10, 10 being most satisfied and 1 being least satisfied.|At the end of study period|||units on a scale||Standard Deviation|Mean
641537|NCT02306759|Secondary|Number of Participants With Adverse Events|Incidence or number of participants with adverse events.|during the study period|Nausea was reported in three patients who received placebo and one patient who received ketamine. Dreams was reported in 1 patient who received placebo and one patient who received ketamine.||participants|||Number
641538|NCT02306759|Primary|Change From Baseline of Pain as Described by Numeric Rating Scale (NRS) [Minimum:0, Maximum 10] at 15 Minutes|Change from Baseline of Pain as described by Numeric Rating Scale (NRS) [minimum:0, maximum 10] at 15 minutes. Lower values indicate worst outcomes while higher values indicate better outcomes.|15 minutes after administration of study intervention|||units on a scale||Inter-Quartile Range|Median
641539|NCT02305446|Other Pre-specified|Number of Adult Volunteers Whose Blood Can be Used as a Reference in Serum Bactericidal Activity (SBA) Test.|The number of identified healthy adult volunteers with pre and postvaccination blood donations were summarized to establish a control sera panel to be used as a reference in SBA test.|Study day 1 blood sample was drawn between day -5 and day 1. Postvaccination 2 blood sample was drawn between day 23 and day 37 postvaccination 2.|The analysis was performed on the all enrolled dataset.||Participants|||Number
641563|NCT02304926|Primary|Non-HDL Cholesterol Before and After Simvastatin/Ezetimibe Administration|Non-HDLc concentration was obtained by calculating the difference between total cholesterol and HDLc|Baseline, 4 weeks and 8 weeks|||mg/dl||Standard Deviation|Mean
641540|NCT02305446|Primary|Number of Subjects Reporting Unsolicited Adverse Events (AEs).|Safety was assessed as the number of the subjects who reported unsolicited AEs following vaccination.|From day 1 to day 7 after each vaccination (Vaccination 1: Day 1 to Day 7; Vaccination 2: Day 61 to Day 67)|Analysis were evaluated on the Unsolicited Safety Set||Subjects|||Number
641541|NCT02305329|Secondary|AUC0-∞ - Area Under the Plasma Concentration-time Curve Extrapolated to Infinity|AUC0-∞ - Area under the plasma concentration-time curve extrapolated to infinity.|before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48h post-OPC dose|||h.ng/mL||Standard Deviation|Mean
641542|NCT02305329|Secondary|AUC0-t - Area Under the Plasma Concentration-time Curve Calculated Between Time of Administration and Time t||before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48h post-OPC dose|||h.ng/mL||Standard Deviation|Mean
641543|NCT02305329|Secondary|Tmax - Time of Occurrence of Cmax of 9-1067|tmax - time of occurrence of Maximum Observed Plasma Concentration of 9-1067|before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48h post-OPC dose|||hours||Full Range|Median
641544|NCT02305329|Primary|Cmax - Maximum Observed Plasma Concentration of 9-1067|Cmax - maximum observed plasma concentration of 9-1067.|before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48h post-OPC dose|||ng/mL||Standard Deviation|Mean
641545|NCT02305316|Secondary|AUC0-inf - Area Under the Plasma Concentration-time Curve From Time 0 to the Infinity|AUC0-inf - Area under the plasma concentration-time curve from time 0 to the infinity.|before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose.|||ng.h/mL||Standard Deviation|Mean
641546|NCT02305316|Secondary|Tmax - Time of Occurrence of Cmax of BIA 9-1067|tmax - time of occurrence of maximum observed plasma concentration of BIA 9-1067|before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose.|||hours||Full Range|Mean
641547|NCT02305316|Secondary|AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to the Time of Last Quantifiable Concentration|AUC0-t - Area under the plasma concentration-time curve from time 0 to the time of last quantifiable concentration of BIA 9-1067|before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose.|||ng.h/mL||Standard Deviation|Mean
641548|NCT02305316|Primary|Cmax - Maximum Observed Plasma Concentration|Maximum observed plasma concentration of BIA 9-1067|before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose.|||ng/mL||Standard Deviation|Mean
641549|NCT02305277|Secondary|Tmax - Time of Occurrence of Cmax||before OPC dosing, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose|||hours||Full Range|Median
641550|NCT02305277|Secondary|AUC0-t - Area Under the Plasma Concentration-time Curve for BIA 9-1067|Area Under the plasma concentration-time Curve from time 0 to the time of last quantifiable concentration|before OPC dosing, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose|||ng.h/mL||Standard Deviation|Mean
641551|NCT02305277|Primary|Cmax - Maximum Observed Plasma Concentration||before OPC dosing, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose|||ng/mL||Standard Deviation|Mean
641552|NCT02305017|Secondary|AUC0-∞ - Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity.|AUC0-∞ - AUC from time 0 to infinity following an oral single-dose of 50 mg OPC administered alone or 1.5 h after last 1 g Paracetamol administration.|before and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hour post-OPC dose|||ng.h/mL||Standard Deviation|Mean
641553|NCT02305017|Secondary|AUC0-t - Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Last Sampling Time at Which the Drug Concentration Was at or Above the Lower Limit of Quantification|AUC0-t - area under the plasma concentration-time curve (AUC) from time zero to the last sampling time following an oral single-dose of 50 mg OPC administered alone or 1.5 h after last 1 g Paracetamol administration|before and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hour post-OPC dose|||ng.h/mL||Standard Deviation|Mean
641554|NCT02305017|Secondary|Tmax - Time of Occurrence of Cmax|Tmax - time of occurrence of Cmax following an oral single-dose of 50 mg OPC administered alone or 1.5 h after last 1 g Paracetamol administration.|before and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hour post-OPC dose|||hours||Full Range|Mean
641555|NCT02305017|Primary|Cmax - Maximum Plasma Concentration|Cmax - Maximum plasma concentration of opicapone on Day 12 following an oral single-dose of 50 mg OPC administered alone or 1.5 h after last 1 g Paracetamol administration|before and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hour post-OPC dose|||ng/mL||Standard Deviation|Mean
641556|NCT02304926|Secondary|Levels of E-selectin Before and After Simvastatin/Ezetimibe Administration|E-selectin was evaluated in serum by Luminex® 200™ system|Baseline, 4 weeks and 8 weeks|||ng/ml||Standard Deviation|Mean
641557|NCT02304926|Secondary|Levels of Intercellular Adhesion Molecule 1 (ICAM-1) Before and After Simvastatin/Ezetimibe Administration|The intercellular adhesion molecule 1 (ICAM-1) was evaluated in serum by Luminex® 200™ system|Baseline, 4 weeks and 8 weeks|||ng/ml||Standard Deviation|Mean
641558|NCT02304926|Secondary|Levels of Vascular Cell Adhesion Molecule 1 (VCAM-1) Before and After Simvastatin/Ezetimibe Administration|The vascular cell adhesion molecule 1 (VCAM-1) was evaluated in serum by Luminex® 200™ system|Baseline, 4 weeks and 8 weeks|||ng/ml||Standard Deviation|Mean
641559|NCT02304926|Primary|Apolipoprotein B Before and After Simvastatin/Ezetimibe Administration|Levels of apolipoprotein B were determined by inmunonephelometry|Baseline, 4 weeks and 8 weeks|||mg/dl||Standard Deviation|Mean
641560|NCT02304926|Secondary|Leukocyte Rolling Velocity Before and After Simvastatin/Ezetimibe Administration|Interactions between leukocytes and human umbilical vein endothelial cells were evaluated by flow chamber microscopy.The rolling velocity in the field of focus was determined by measuring the time required by 20 consecutive leukocytes to cover a distance of 100 μm.|Baseline, 4 weeks and 8 weeks|||micrometer/second||Standard Deviation|Mean
641561|NCT02304926|Secondary|Leukocyte Adhesion Before and After Simvastatin/Ezetimibe Administration|Interactions between leukocytes and human umbilical vein endothelial cells were evaluated by flow chamber microscopy. Adhesion was evaluated by counting the number of polymorphonuclear cells that maintained stable contact with human umbilical vein endothelial cells (HUVEC) for 30 seconds.|Baseline, 4 weeks and 8 weeks|||polymorphonuclear cells/mm2||Standard Deviation|Mean
641562|NCT02304926|Primary|Low Density Lipoprotein Size Before and After Simvastatin/Ezetimibe Administration|LDL subfractions were separated by high-resolution polyacrylamide gel tubes using the Lipoprint® system. The LDL electrophoretic profile allows 2 patterns to be defined: pattern A or large and buoyant LDL, and pattern non-A or small and dense LDL.|Baseline, 4 weeks and 8 weeks|||Angström||Standard Deviation|Mean
641564|NCT02304926|Secondary|Leukocyte Rolling Flux Before and After Simvastatin/Ezetimibe Administration|Interactions between leukocytes and human umbilical vein endothelial cells were evaluated by flow chamber microscopy. Leukocyte rolling was estimated as the number of leukocytes rolling over 100 μm2 of the endothelial monolayer during a 1-min period.|Baseline, 4 weeks and 8 weeks|||polymorphonuclear cells/min||Standard Deviation|Mean
641565|NCT02304926|Secondary|Levels of Glutathione (GSH) Before and After Simvastatin/Ezetimibe Administration|Oxidative stress markers (levels of glutathione (GSH)) was measured at baseline and after treatment by fluorometric techniques|Baseline, 4 weeks and 8 weeks|||Fluorescence Units||Standard Deviation|Mean
641566|NCT02304926|Secondary|Membrane Potential Before and After Simvastatin/Ezetimibe Administration|Oxidative stress markers (membrane potential) was measured at baseline and after treatment by fluorometric techniques|Baseline, 4 weeks and 8 weeks|||Fluorescence Units||Standard Deviation|Mean
641567|NCT02304926|Secondary|Reactive Oxygen Species (ROS) Production Before and After Simvastatin/Ezetimibe Administration|Oxidative stress markers (Reactive oxygen species (ROS) production) was measured at baseline and after treatment by fluorometric techniques|Baseline, 4 weeks and 8 weeks|||Fluorescence Units||Standard Deviation|Mean
641568|NCT02304926|Secondary|Mitochondrial Oxygen (O2) Consumption Before and After Simvastatin/Ezetimibe Administration|Oxidative stress markers (mitochondrial oxygen (O2) consumption) was measured at baseline and after treatment by Clark electrode|Baseline, 4 weeks and 8 weeks|||Nmol O2/min/million cells||Standard Deviation|Mean
641569|NCT02304926|Primary|Triglycerides Before and After Simvastatin/Ezetimibe Administration|Triglyceride concentration were measured by enzymatic assay|Baseline, 4 weeks and 8 weeks|||mg/dl||Inter-Quartile Range|Median
641570|NCT02304926|Primary|High-density Lipoprotein Cholesterol (HDLc) Before and After Simvastatin/Ezetimibe Administration|High-density lipoprotein cholesterol (HDLc) concentration was measured using a direct method|Baseline, 4 weeks and 8 weeks|||mg/dl||Standard Deviation|Mean
641571|NCT02304926|Secondary|Levels of Tumor Necrosis Factor α (TNF-α) Before and After Simvastatin/Ezetimibe Administration|Levels of proinflammatory cytokines (tumor necrosis factor α (TNF-α)) were analysed with a Luminex® 200™ system|Baseline, 4 weeks and 8 weeks|||pg/ml||Standard Deviation|Mean
641572|NCT02304926|Secondary|Levels of Interleukin-6 (IL-6) Before and After Simvastatin/Ezetimibe Administration|Levels of proinflammatory cytokines (interleukin-6 (IL-6)) were analysed with a Luminex® 200™ system|Baseline, 4 weeks and 8 weeks|||pg/ml||Standard Deviation|Mean
641573|NCT02304926|Secondary|Levels of High-sensitive C-reactive Protein (hsCRP) Before and After Simvastatin/Ezetimibe Administration|Levels of high-sensitive C-reactive protein (hsCRP) were analysed by a latex-enhanced inmunonephelometric assay|Baseline, 4 weeks and 8 weeks|||mg/l||Standard Deviation|Mean
641574|NCT02304926|Primary|Low-density Lipoprotein Cholesterol (LDLc) Before and After Simvastatin/Ezetimibe Administration|Low-density lipoprotein cholesterol (LDLc) concentration was calculated using the method of Friedewald.|Baseline, 4 weeks and 8 weeks|||mg/dl||Standard Deviation|Mean
641575|NCT02304926|Primary|Total Cholesterol Before and After Simvastatin/Ezetimibe Administration|Total cholesterol concentration was measured by enzymatic assay|Baseline, 4 weeks and 8 weeks|||mg/dl||Standard Deviation|Mean
641576|NCT02304432|Secondary|Auditory Evoked Potentials - P50 Ratio (P50 S2/S1) (Amplitude)|Auditory evoked potential amplitude: P50 ratio (P50 S2/S1)|Baseline and Week 8 of DCS treatment|Only one subject had normal hearing, which is required for valid data collection.||ratio|||Number
641577|NCT02304432|Secondary|Auditory Evoked Potentials in Gamma Oscillations (the Power Spectrum is Measured in Microvolts Squared)|Auditory evoked potential gamma: G40 hz phase locking at fz and cz; G30 hz phase locking at fz and cz; G20 hz phase locking at fz and cz|Baseline and Week 8 of DCS treatment|Only one subject had normal hearing, which is required for valid data collection.||microvolts squared|||Number
641578|NCT02304432|Secondary|Auditory Evoked Potentials in Amplitude (Degrees Measured in Microvolts)|Auditory evoked potential amplitude: P300 at fz, cz, and pz; N100 at fz and cz; P200 at fz and cz; P50 S1 and S2; mismatch negativity (MMN) at fz and cz.|Baseline and Week 8 of DCS treatment|Only one subject had normal hearing, which is required for valid data collection.||microvolts|||Number
641579|NCT02304432|Secondary|Auditory Evoked Potentials in Latency (Msec)|Auditory evoked potential latency: P300 at fz, cz, and pz; N100 at fz and cz; P200 at fz and cz.|Baseline and Week 8 of DCS treatment|Only one subject had normal hearing, which is required for valid data collection.||msec|||Number
641580|NCT02304432|Secondary|Brain Glycine/CR Ratio|Proton magnetic resonance spectroscopy at 4T: brain glycine/CR ratio. Participants were assessed at baseline (pre-glycine challenge dose and 60, 80, 100 and 120 minutes post glycine dose) and in week 8 of of open-label DCS treatment: pre-DCS dose, and 60, 80, 100 and 120 minutes post DCS dose. Measured in posterior occipital cortex.|Baseline and Week 8 of DCS treatment|Data collected only during only one of the open label periods for financial and logistical reasons. Data were collected in week 8 of the first open-label DCS exposure in one subject and in week 8 of the second open-label DCS exposure in the other subject for logistical reasons.||ratio||Full Range|Median
641581|NCT02304432|Secondary|Neurocognitive Function|Scores on each of 8 domains of cognitive function (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning/problem solving, social cognition, overall composite). Scores are T scores ranging from 0-100, with 50 representing the mean for a population based on a normal distribution, standard deviation of 10. Higher scores signify better functioning.|Baseline and Week 8 of open-label DCS treatment|The on DCS data were collected during week 8 of the first open-label portion of the study in one subject and in week 8 of the second open-label portion of the study in the other subject for logistical reasons.||T scores||Full Range|Median
641582|NCT02304432|Primary|Depression Symptom Scores|Hamilton Depression Scale (HAM) measures severity of depression symptoms. The sum of the ratings for 9 depression symptoms is measured on a scale of 0-2 with 0 meaning no depression symptoms and 2 meaning some level of severity of that specific symptom. The rating for one depression symptom is measured on a scale of 0-3 with 0 meaning no depression symptoms and 3 meaning a severe level of that specific symptom. The sum of ratings for 11 depression symptoms is measured on a scale of 0-4, with 0 meaning no symptoms and 4 meaning a severe level of that specific symptom. The three sums are added to produce an overall depression rating scale score ranging from 0-65. Higher scores indicate worse depression symptoms.|Baseline, 2, 4, & 6 weeks (crossover periods)|||units on a scale|||Number
648266|NCT02107014|Primary|Change in IL-27 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].|||pg/mL||95% Confidence Interval|Median
641583|NCT02304432|Primary|Mania Symptom Scores|Young Mania Rating Scale (YMRS) measures severity of manic symptoms. The sum of the ratings for 7 symptoms of mania is measured on a scale of 0-4 and the sumof 4 symptoms of mania is measured on a scale of 0-8 to yield a total score ranging from 0-60, with 0 meaning no manic symptoms and 60 meaning severe manic symptoms.|Baseline, 2, 4, & 6 weeks (crossover periods)|||units on a scale|||Number
641584|NCT02304432|Primary|Depression Symptom Scores|Hamilton Depression Scale (HAM) measures severity of depression symptoms. The sum of the ratings for 9 depression symptoms is measured on a scale of 0-2 with 0 meaning no depression symptoms and 2 meaning some level of severity of that specific symptom. The rating for one depression symptom is measured on a scale of 0-3 with 0 meaning no depression symptoms and 3 meaning a severe level of that specific symptom. The sum of ratings for 11 depression symptoms is measured on a scale of 0-4, with 0 meaning no symptoms and 4 meaning a severe level of that specific symptom. The three sums are added to produce an overall depression rating scale score ranging from 0-65. Higher scores indicate worse depression symptoms.|Baseline & at 2, 4, 6 & 8 Weeks during open-label phase 1 and every 2 weeks up to 24 weeks during open label phase 2|||units on a scale||Full Range|Median
641585|NCT02304432|Primary|Mania Symptom Scores|Young Mania Rating Scale (YMRS) measures severity of manic symptoms. The sum of the ratings for 7 symptoms of mania is measured on a scale of 0-4 and the sumof 4 symptoms of mania is measured on a scale of 0-8 to yield a total score ranging from 0-60, with 0 meaning no manic symptoms and 60 meaning severe manic symptoms.|Baseline & at 2, 4, 6 & 8 Weeks during open-label phase 1 and every 2 weeks up to 24 weeks during open label phase 2|||units on a scale||Full Range|Median
641586|NCT02304432|Primary|Clinical Global Impression (CGI) Severity Scores|CGI severity scores measure severity of mental illness on a scale of 1-7 where 1 means normal, not at all ill, 2 means borderline mentally ill, 3 means mildly ill, 4 means moderately ill, 5 means markedly ill, 6 means severely ill and 7 means among the most extremely ill patients.|Baseline, 2, 4, & 6 weeks (crossover periods)|||units on a scale|||Number
641587|NCT02304432|Primary|Clinical Global Impression (CGI) Severity Scores|CGI severity scores measure severity of mental illness on a scale of 1-7 where 1 means normal, not at all ill, 2 means borderline mentally ill, 3 means mildly ill, 4 means moderately ill, 5 means markedly ill, 6 means severely ill and 7 means among the most extremely ill patients.|Baseline & at 2, 4, 6 & 8 Weeks during open-label phase 1 and every 2 weeks up to 24 weeks during open label phase 2|||units on a scale||Full Range|Median
641588|NCT02304432|Primary|Brief Psychiatric Rating Scale (BPRS) Scores|Total BPRS score measures severity of 18 psychiatric symptoms. Each symptom is scored 1-7 with the total score ranging from 18-126. 18 means no symptoms and 126 means very severe symptoms.|Baseline, 2, 4, & 6 weeks (crossover periods)|||units on a scale|||Number
641589|NCT02304432|Primary|Brief Psychiatric Rating Scale (BPRS) Scores|Total BPRS score measures severity of 18 psychiatric symptoms. Each symptom is scored 1-7 with the total score ranging from 18-126. 18 means no symptoms and 126 means very severe symptoms.|Baseline & at 2, 4, 6 & 8 Weeks during open-label phase 1 and every 2 weeks up to 24 weeks during open label phase 2|||units on a scale||Full Range|Median
641590|NCT02304432|Primary|Positive and Negative Symptom Scores|Positive and Negative Symptom Scale (PANSS) measures positive and negative symptoms of schizophrenia. The sum of ratings for seven positive symptoms is measured on a scale from 7-49 with 7 meaning no symptoms and 49 meaning severe symptoms.The sum of ratings for seven negative symptoms is measured on a scale from 7-49 with 7 meaning no symptoms and 49 meaning severe symptoms.|Baseline, 2, 4, & 6 weeks (crossover periods)|||units on a scale|||Number
641591|NCT02304432|Primary|Positive and Negative Symptom Scores|Positive and Negative Symptom Scale (PANSS) measures positive and negative symptoms of schizophrenia. The sum of ratings for seven positive symptoms is measured on a scale from 7-49 with 7 meaning no symptoms and 49 meaning severe symptoms.The sum of ratings for seven negative symptoms is measured on a scale from 7-49 with 7 meaning no symptoms and 49 meaning severe symptoms.|Baseline & at 2, 4, 6 & 8 Weeks during open-label phase 1 and every 2 weeks up to 24 weeks during open label phase 2|||units on a scale||Full Range|Median
641592|NCT02303743|Secondary|Patient Satisfaction Were Assessed With a Specific Questionnaire|Patient satisfaction were assessed with a specific questionnaire before colonoscopy. Patients were asked if they used the application and their satisfaction with the app. Again, the endoscopist was blinded to the answers. The items read as follows: (1) “Do you have experience with a previous colonoscopy?”; (2) “Have you used the phone application?”; (3) “How easy was the preparation for colonoscopy?”; (4) “Which is your level of satisfaction with the bowel preparation?”; (5) “Would you like to repeat the same preparation in the future?”; (6) “Did you have any difficulty with the preparation?”. Patient responses to the questionnaire were categorical (yes or no; questions 1, 2, 5, and 6) or numerical scale answers (0 to 10), from very difficult or very bad (0 or close to 0) to very easy or very good (10 or close to 10) (items 3 and 4).|Day 1|||units on a scale||Standard Deviation|Mean
641593|NCT02303743|Primary|Bowel Preparation Was Evaluated Using the Harefield Cleansing Scale (HCS). The Scale Was the Primary Outcome Measure|The quality of bowel cleansing is evaluated after colonoscopy (Day 1). Baseline the patients initiated low fiber diet in the 24 hours prior to colonoscopy. The HCS uses a 5-point qualitative scale in 5 separate colon segments. HCS is the sum of 5 segments, ranging from 0 (worst possible outcome) to 20 (best possible outcome). Global score assesses the quality of bowel cleansing: Successful (A or B) / unsuccessful (C or D). A: All segments scored 3 or 4; B: One or more segments scored 2; C: One or more segments scored 1; and D: One or more segments scored 0.|Day 1|||units on a scale||Standard Deviation|Mean
641594|NCT02303704|Secondary|Operative Mortality|Deaths due to surgical complication during or after surgery.|Within 30 days after surgical Procedure|all patients who underwent surgery and monitored for death due to surgical complication.||participants|||Number
641595|NCT02303704|Secondary|Intra-aortic Balloon Pump Counter-pulsation (IABPC) Support|The need of IABPC (mechanical support) before surgery or during weaning from Cardiopulmonary bypass and in ICU to assist in maintaining hemodynamics of the patient.|24 hours before surgery and upto 1 week of surgical procedure.|All patients who underwent surgery and for whom IABP support was required.||participants|||Number
641596|NCT02303704|Secondary|Pharamacological Inotropic Support (Dobutamine)|The Need, Dose and duration of Dobutamine to maintain hemodynamic stability after surgery.|Upto 1 week after sugery|All patients in whom Dobutamine was used to wean off the patients from Cardiopulmonary Bypass.||ug/kg/min||Standard Deviation|Mean
678085|NCT01601977|Secondary|Exercise Capacity|6 minute walk test|6 weeks|1 patient declined to complete the walking test||m||Standard Deviation|Mean
641597|NCT02303704|Secondary|Pharmacological Inotropic Support (Nor-adrenaline)|The need, dose and duration of Nor-adrenaline infusion to maintain hemodynamic stability after surgery.|Upto 1 week after sugery|All patients in whom Nor-adrenaline was used to wean off the patients from Cardiopulmonary Bypass.||ug/kg/min||Standard Deviation|Mean
641598|NCT02303704|Secondary|Pharmacologic Inotropic Support (Adrenaline)|The need, dose and duration of adrenaline infusion to maintain hemodynamic stability after surgery were noted.|Upto 1 week after sugery|All patients in whom Adrenaline was used to wean off the patients from Cardiopulmonary Bypass.||ug/kg/min||Standard Deviation|Mean
641599|NCT02303704|Primary|Post-op CK-MB Levels|CK-MB is a marker of Myocardial Damage.|36 hours after surgery.|All patients in whom Peak CKMB levels were noted within 24 hours after surgery||IU/L||Standard Deviation|Mean
641600|NCT02302365|Other Pre-specified|Waste Bag Volume|Volume of the depletion product|Post each Spectra Optia Apheresis Procedure|Full and Safety Analysis Sets||mL|Participants|Standard Deviation|Mean
641601|NCT02302365|Other Pre-specified|Platelet Change (% Change)|% change in patient's pre and post-depletion procedure platelet counts|Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours.|Data were collected on a total of 58 procedures, however one patient terminated her first procedure prematurely and therefore did not have post-procedure data.||percent change|Participants|Standard Deviation|Mean
641602|NCT02302365|Other Pre-specified|Procedure Duration||Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours.|Full and Safety Analysis Sets||minutes|Participants|Standard Deviation|Mean
641603|NCT02302365|Other Pre-specified|Average Inlet Flow Rate||Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours.|Full and Safety Analysis Set||mL/min|Participants|Standard Deviation|Mean
641604|NCT02302365|Post-Hoc|Total Blood Volumes (TBV) Processed|Number of times the patient's TBV was processed during the apheresis procedure based on the patient's estimated TBV (Estimated by Nadler's formula for total blood volume of a human being based on gender, height, and weight).|Post each Spectra Optia Apheresis Procedure|Full and Safety Analysis Sets||TBV|Participants|Standard Deviation|Mean
641605|NCT02302365|Other Pre-specified|Whole Blood Processed (mL)|volume of patient's blood processed during the apheresis procedure|Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours.|Full and Safety Analysis Sets||mL|Participants|Standard Deviation|Mean
641606|NCT02302365|Other Pre-specified|Patient's Platelet Count Post-depletion Procedure||Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours.|Full and Safety Analysis Sets. Data were collected on a total of 58 procedures, however one patient terminated her first procedure prematurely and therefore did not have post-procedure data.||cells x 10^3/L|Participants|Standard Deviation|Mean
641607|NCT02302365|Other Pre-specified|Patient's Platelet Count Pre-depletion Procedure||Prior to Each Spectra Optia Apheresis Procedure|Full and Safety Analysis Sets.||cells x 10^3/L|Participants|Standard Deviation|Mean
641608|NCT02302365|Other Pre-specified|Patient's WBC Count Post-depletion Procedure||Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours.|Full and Safety Analysis Sets. Data were collected on a total of 58 procedures, however one patient terminated her first procedure prematurely and therefore did not have post-procedure data.||cells x 10^9/L|Participants|Standard Deviation|Mean
641609|NCT02302365|Other Pre-specified|Patient's WBC Count Pre-depletion Procedure||Prior to Each Spectra Optia Apheresis Procedure|Full and Safety Analysis Sets.||cells x 10^9/L|Participants|Standard Deviation|Mean
641610|NCT02302365|Primary|Adverse Events||Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours.|Full and Safety Analysis Sets. 53.5% of subjects with acute myeloid leukemia (AML), 18.6% of subjects with chronic lymphocytic leukemia, < 10% of subjects with other diagnoses. The WBCD procedure was performed most frequently to treat leukocytosis (44.2%), to prevent tumor lysis syndrome (34.9%), or to treat increased blood viscosity (20.9%).||Number of subjects with at least 1 AE|||Number
641611|NCT02302365|Primary|Collection Efficiency (CE) for WBC (or Percent of Processed WBCs) Achieved by Spectra Optia.|(WBC/µL product x product volume) / ((WBCpre + WBCpost) / 2) x total processed blood volume)|immediately: on average this will be within 15minutes after the end of the procedure|The CE of the WBCD procedures as measured from the waste bag (depletion product) contents was 58.7% (SD: 16.1%) across Sites 2 and 3. WBC counts were not available from the waste bags for subjects treated at Site 1.||percent of processed WBCs|Participants|Standard Deviation|Mean
641612|NCT02302365|Primary|Percent Change in White Blood Cell Count in Patient Following Apheresis Procedure|(WBCpre - WBCpost) / WBCpre x 100%|immediately after procedure: on average this will be within 15minutes after the end of the procedure|Full and Safety Analysis Sets. Data were collected for 43 subjects who underwent a total of 58 WBCD procedures. One subject terminated her first procedure prematurely and therefore did not have post-procedure data. Percent decrease in white blood cell count in patient following apheresis procedure measured for 57 procedures in 43 subjects.||% change in subject's WBC count|Participants|Standard Deviation|Mean
641655|NCT02300025|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]|AUC (0-t) was defined as area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t).|Pre-dose (0 hrs), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, 216, 264, 336, 456, and 576 hrs post-dose|PK Population.||ng*hr/mL||Standard Deviation|Mean
641620|NCT02301936|Secondary|Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)|The FACIT-Fatigue score was measured using a 40-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale from 0 (Not at all) to 4 (Very much). The FACIT-F total score was calculated by taking the sum of all 40 individual scores and ranged from 0-160, with higher scores indicating better quality of life.|Weeks 4,12, 24, Posttreatment Weeks 4 and 12|Participants in the Full Analysis Set with available data were analyzed.||units on a scale||Standard Deviation|Mean
641621|NCT02301936|Secondary|Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Short Form (SF-36) Health Survey Scale- Mental Component Score|The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). The last 5 concepts constitute the mental component summary. The total score is an average of the individual question scores, which are scaled 0-100 with lower score representing more disability and higher scores representing less disability.|Weeks 4,12, 24, Posttreatment Weeks 4 and 12|Participants in the Full Analysis Set with available data were analyzed.||units on a scale||Standard Deviation|Mean
641622|NCT02301936|Secondary|Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Short Form (SF-36) Health Survey Scale- Physical Component Score|The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). The first 6 concepts constitute the physical component summary. The total score is an average of the individual question scores, which are scaled 0-100 with lower scores representing more disability and higher scores representing less disability.|Weeks 4,12, 24, Posttreatment Weeks 4 and 12|Participants in the Full Analysis Set with available data were analyzed.||units on a scale||Standard Deviation|Mean
641656|NCT02300025|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||Pre-dose (0 hrs), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, 216, 264, 336, 456, and 576 hrs post-dose|PK population.||hrs||Full Range|Median
641691|NCT02298868|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Encephalopathy)|Proportion of patients with endephalopathy at any time during the 4 weeks of therapy|4 weeks of active therapy|||participants|||Number
641623|NCT02301936|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as
On-treatment virologic failure
HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ, while on treatment,
> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, HCV RNA persistently ≥ LLOQ through 8 weeks of treatment (ie nonresponse)
Relapse
HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement"|Up to Posttreatment Week 12|Full Analysis Set||percentage of participants|||Number
641624|NCT02301936|Secondary|HCV RNA Change From Baseline||Up to 24 weeks|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
641625|NCT02301936|Secondary|Percentage of Participants With HCV RNA < LLOQ on Treatment||Weeks 1, 2, 4, 8,12, 16, 20, and 24|Full Analysis Set||percentage of participants|||Number
641626|NCT02301936|Secondary|Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4)|SVR4 was defined as HCV RNA < the LLOQ 4 weeks following the last dose of study drug.|Posttreatment Week 4|Full Analysis Set||percentage of participants|||Number
641627|NCT02301936|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 24 weeks|Safety Analysis Set||percentage of participants|||Number
641628|NCT02301936|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.|Posttreatment Week 12|Full Analysis Set: participants who took at least 1 dose of study drug||percentage of participants|||Number
641629|NCT02301429|Primary|All Implant Procedure and Lead Related Adverse Events Will be Collected During the First Month Post Implant and Analyzed.|All Implant procedure and lead related adverse events will be collected during the first month post implant and analyzed.|1 month|all subject who underwent a Model 20105 Lead implant attempt are considered in this analysis||Adverse Events|||Number
641630|NCT02301377|Secondary|Cystic Fibrosis Questionnaire-Revised (CFQ-R) Treatment Burden Domain Score (Parent)|Response of the parents/caregivers to the treatment burden domain of the CFQ-R at the end of 3-months|3 months|||units on a scale||Standard Deviation|Mean
641631|NCT02301377|Secondary|Cystic Fibrosis Questionnaire-Revised (CFQ-R)Treatment Burden Domain Score (Child)|Response of the participants to the treatment burden domain of the CFQ-R at the end of 3 months|3 months|||units on a scale||Standard Deviation|Mean
641632|NCT02301377|Primary|Medication Adherence|Overall adherence to inhaled hypertonic saline, dornase alfa and CF multivitamins based on prescription refill data. The actual number of prescriptions of each of the three medications filled in the 3-month period was divided by the number that should have been filled based on the prescribed amount of each medication and that value was multiplied by a 100 to generate a percentage.|3 months|||Percent Adherence||Standard Deviation|Mean
641633|NCT02301169|Secondary|Patient 's Change From Baseline of Pain Severity as Measured by the Weekly Means of the Brief Pain Inventory (BPI).|"Arithmetic average of 3 questions on an 11-point Numeric Rating Scale (NRS) from 0 to 10, 0 meaning no pain, 10 pain as bad as you can imagine.
Lower values represent a better outcome"|Time zero equals baseline (Day 1) up to Day 28|||units on a scale||Standard Deviation|Mean
641634|NCT02301169|Secondary|Patient's Change of Pain Intensity After Heat Pain Stimuli From Baseline to End of Treatment Period|11-point Numeric Rating Scale (NRS) from 0 to 10; 0 meaning no pain, 10 pain as bad as you can imagine Lower values represent a better outcome Unit: arithmetic average on 6 reported scores per Visit.|Time zero equals baseline (Day 1) up to Day 28|||units on a scale||Standard Deviation|Mean
641635|NCT02301169|Secondary|Patient's Change From Baseline of Investigator Global Assessment of Change (IGAC)|IGAC is an investigator subjective evaluation of patient condition using a NRS from 0 to 10 with 0 meaning best and 10 worst Lower values represent a better outcome.|Time zero equals baseline (Day 1) up to Day 28|||units on a scale||Standard Deviation|Mean
641636|NCT02301169|Secondary|Patient 's Change From Baseline of Pain Severity as Measured by the Weekly Means of the Daily Worst Pain Scores (WPS)|11-point Numeric Rating Scale (NRS) Scale from 0 to 10, 0 meaning no pain, 10 pain as bad as you can imagine. Lower values represent a better outcome. Unit: arithmetic average of 7 days of a 11-point NRS|Time zero equals baseline (Day 1) up to Day 42|||units on a scale||Standard Deviation|Mean
641637|NCT02301169|Primary|Patient 's Change From Baseline of Pain Severity as Measured by the Weekly Means of the Daily Average Pain Scores (APS) During 4 Weeks of Treatment|11-point Numeric Rating Scale (NRS). Scale from 0 to 10, 0 meaning no pain, 10 pain as bad as you can imagine. Lower values represent a better outcome. Unit: arithmetic average of 7 days of a 11-point NRS|Time zero equals baseline (Day 1) up to Day 42|||units on a scale||Standard Deviation|Mean
641638|NCT02300311|Secondary|Patient's Assessment of the Efficacy on the Last Individual Treatment Day|Patients were asked to rate the effect of the study medication for relieving their low back pain using a 4-point verbal rating scale (1=Poor, 2= Fair, 3=Good, 4=Very Good).|1 to 4 days|Full analysis set (FAS): All patients included in the treated set who provide any post-treatment data for the primary efficacy endpoint constituted the full analysis set.||percentage of participants|||Number
641639|NCT02300311|Secondary|Difference of Average Pain Intensity (APID) From Pre-dose Baseline on the Last Individual Treatment Day|"Difference of average pain intensity from pre-dose baseline on the last individual treatment day (The last individual treatment day was the last day on which the patient had recorded the study drug applications within the patient diary). Pain intensity was assessed by the patient using 0-10 numerical rating scale (NRS).
Patients were given two 0-10 numerical rating scales (NRS) - to self-report of pain intensity at given time points for the period 0-8 hours post first dose and to self-report of average pain intensity they had at each treatment day. The left side of each scale (0) is marked ‘no pain’ and the right side of the scale (10) is marked ‘worst pain possible’. APIDtime point = APItime point - PI baseline (time point is the last individual treatment day (either Day 1, 2, 3 or 4 after drug administration)).
Means reported are the adjusted means."|Baseline and 1 to 4 days|Full analysis set (FAS): All patients included in the treated set who provide any post-treatment data for the primary efficacy endpoint constituted the full analysis set.||points on a scale||Standard Error|Mean
641657|NCT02300025|Primary|Maximum Observed Plasma Concentration (Cmax)||Pre-dose (0 hours [hrs]), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, 216, 264, 336, 456, and 576 hrs post-dose|Pharmacokinetic (PK) population included all participants who received at least one dose of cobimetinib and had evaluable PK data.||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
641640|NCT02300311|Secondary|Pain Intensity Difference (PID) From Pre-dose Baseline to 4 Hours After the First Trial Medication Application (PID4h)|Pain intensity was assessed on a 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst pain possible) at pre-dose baseline and 0.5, 1, 2, 3 and 4 hours after trial medication application. The left side of each scale (0) is marked ‘no pain’ and the right side of the scale (10) is marked ‘worst pain possible’. PID4h= PI(4h) - PI(baseline). Means reported are the adjusted means.|Baseline and 4 hours after trial medication application|Full analysis set (FAS): All patients included in the treated set who provide any post-treatment data for the primary efficacy endpoint constituted the full analysis set.||points on a scale||Standard Error|Mean
641641|NCT02300311|Primary|Pain Intensity Difference (PID) From Pre-dose Baseline to 8h After the First Trial Medication Application (PID8h)|"Pain intensity (PI) was assessed on a 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst pain possible) at pre-dose baseline and 0.5, 1, 2, 3, 4, 6 and 8 hours after trial medication application.
The left side of each scale (0) is marked ‘no pain’ and the right side of the scale (10) is marked ‘worst pain possible’.
PID8h= Pain intensity (PI)8h - PI(baseline).
Means reported are the adjusted means."|Baseline and 8 hours after trial medication application|Full analysis set (FAS): All patients included in the treated set who provide any post-treatment data for the primary efficacy endpoint constituted the full analysis set.||points on a scale||Standard Error|Mean
641642|NCT02300129|Primary|Total Number of Flushes for Each 2-week Period||Day 22 and Day 36/Early termination|Per protocol population of Period 2, N= 31||Flushes count||Standard Deviation|Mean
641643|NCT02300103|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as:
On-treatment virologic failure:
Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)
Virologic relapse:
Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit"|Up to Posttreatment Week 24|Full Analysis Set||percentage of participants|||Number
641644|NCT02300103|Secondary|HCV RNA Change From Baseline||Baseline to Week 24|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
641645|NCT02300103|Secondary|Percentage of Participants With HCV RNA < LLOQ On-treatment||Baseline to Week 24|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants||95% Confidence Interval|Number
641646|NCT02300103|Secondary|Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 are defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug.|Posttreatment Weeks 4 and 24|Full Analysis Set||percentage of participants||95% Confidence Interval|Number
641647|NCT02300103|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 24 weeks|Safety Analysis Set||percentage of participants|||Number
641648|NCT02300103|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.|Posttreatment Week 12|Full Analysis Set: all enrolled participants who received at least one dose of study drug.||percentage of participants||95% Confidence Interval|Number
641649|NCT02300025|Primary|Apparent Volume of Distribution (Vz/F)|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vz/F after the oral dose is influenced by the fraction absorbed.|Pre-dose (0 hrs), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, 216, 264, 336, 456, and 576 hrs post-dose|PK population. Here, number of participants analyzed signified those participants who were evaluable for this outcome.||Liter||Standard Deviation|Mean
641650|NCT02300025|Primary|Apparent Oral Clearance (CL/F)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Pre-dose (0 hrs), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, 216, 264, 336, 456, and 576 hrs post-dose|PK population. Here, number of participants analyzed signified those participants who were evaluable for this outcome.||Liter per hr (L/hr)||Standard Deviation|Mean
641651|NCT02300025|Primary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration of cobimetinib to decrease by one half.|Pre-dose (0 hrs), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, 216, 264, 336, 456, and 576 hrs post-dose|PK population. Here, number of participants analyzed signified those participants who were evaluable for this outcome.||hr||Standard Deviation|Mean
641652|NCT02300025|Primary|Apparent Terminal Elimination Rate Constant (λZ)|λZ was defined as the magnitude of the slope of the linear regression of the log concentration versus time profile during the terminal phase.|Pre-dose (0 hrs), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, 216, 264, 336, 456, and 576 hrs post-dose|PK population. Here, number of participants analyzed signified those participants who were evaluable for this outcome.||1 per hr (1/hr)||Standard Deviation|Mean
641653|NCT02300025|Primary|Extrapolated Area Under the Curve (AUC Percent [%] Extrapolated)|AUC% extrapolated was defined as the percentage of AUC [0-∞] obtained by forward extrapolation. It is calculated as [AUC (0-∞) minus AUC(0-t]*100/ AUC (0-∞), where AUC [0-∞] = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-∞) and AUC(0-t) is area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration.|Pre-dose (0 hrs), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, 216, 264, 336, 456, and 576 hrs post-dose|PK population. Here, number of participants analyzed signified those participants who were evaluable for this outcome.||% extrapolated||Standard Deviation|Mean
641654|NCT02300025|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]|AUC (0 - ∞) was defined as AUC from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t- ∞).|Pre-dose (0 hrs), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, 216, 264, 336, 456, and 576 hrs post-dose|PK population. Here, number of participants analyzed signified those participants who were evaluable for this outcome.||ng*hr/mL||Standard Deviation|Mean
641658|NCT02299869|Primary|Comfort Preference|Participant's subjective preference for comfort on a 3 point Likert Scale. 1=prefer CVI-test lens, 2=prefer Competitor-control lens, 3=no preference|20 minutes|||participants|||Number
641663|NCT02299791|Primary|Patients Indicated for ACE/ARB and Statin Who Had an Active Prescription for Both|Number of patients indicated for ACE/ARB and statin who had an active prescription for both, as a proportion of patients indicated for ACE/ARB and statin.|Percent of clinic patients prescribed guideline-concordant cardioprotective medications, as of the 1st day of each month, from up to 36 months|clinic patients with diabetes who had a clinic encounter (in person or by telephone) within the previous year and were indicated for ACE/ARB and statin per current national care guidelines||Participants|||Count of Participants
641664|NCT02299635|Secondary|Number of Notch Genomic Alterations in Participants With NA+ mTNBC|Number of notch genomic alterations identified by NGS assay in patients with NA+ mTNBC|2 years|Data for this outcome measure was not collected due to early termination of this study.|||||
641665|NCT02299635|Secondary|Number of Participants With Laboratory Test (Urinalysis) Abnormalities|Number of participants with CTCAE version 4.03 grade 1 to 4 urinalysis test abnormalities for urine protein.|Day 1 of Cycle 1|The safety analysis set included all enrolled participants who received at least one dose of study medication.||participants|||Number
641666|NCT02299635|Secondary|Number of Participants With Laboratory Test (Chemistry) Abnormalities|Number of participants with CTCAE version 4.03 grade 1 to 4 chemistry test abnormalities|Day 1 and Day 15 of Cycles 1, 2, 3, 4, 5, and subsequent cycles up to Cycle 8 and Day 8 of Cycle 1|The safety analysis set included all enrolled participants who received at least one dose of study medication.||participants|||Number
641667|NCT02299635|Secondary|Number of Participants With Laboratory Test (Hematology) Abnormalities|Number of participants with CTCAE version 4.03 grade 1 to 4 hematological test abnormalities.|Day 1 of Cycles 1, 2, 3, 4, 5, and subsequent cycles.|The safety analysis set included all enrolled participants who received at least one dose of study medication.||participants|||Number
641668|NCT02299635|Secondary|Number of Participants With Treatment-Emergent AEs by CTCAE Grade|An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. AEs were defined according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.|2 years|The safety analysis set included all enrolled participants who received at least one dose of study medication.||participants|||Number
641669|NCT02299635|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were defined as all deaths, regardless of cause, from treatment start until 28 days after the last dose and non-fatal events occurring after treatment start regardless of cause, up until 28 days after the last dose or until start of new anti-cancer treatment, whichever was first.|2 years|The safety analysis set included all enrolled participants who received at least one dose of study medication.||participants|||Number
641670|NCT02299635|Secondary|Alterations in Genes, Proteins, and RNAs Relevant to the Notch Signaling Pathway, to TNBC Biology, and to Sensitivity/Resistance to PF-03084014 in Tumor Specimens and Peripheral Blood.|Original diagnostic tumor tissue or the most recent metastatic tumor (archival or de novo biopsy), plasma, and peripheral blood samples were collected for biomarker assessments of circulating analytes, immunohistochemistry for notch receptors expression, expression of notch pathway components and modulators, mutational analysis of pathway and disease associated genes.|Day 1 of Cycle 1, 2, 3, and 5|Due to study termination, no PD analyses were performed for this study.|||||
641671|NCT02299635|Secondary|Pharmacodynamic (PD) Effects of PF‑03084014 in Tumor Specimens and Peripheral Blood|Original diagnostic tumor tissue or the most recent metastatic tumor (archival or de novo biopsy), plasma, and peripheral blood samples were collected for biomarker assessments of circulating analytes, immunohistochemistry for notch receptors expression, expression of notch pathway components and modulators, mutational analysis of pathway and disease associated genes.|Day 1 of Cycle 1, 2, 3, and 5|Due to study termination, no PD analyses were performed for this study.|||||
641672|NCT02299635|Secondary|Pre-dose Serum Concentration (Ctrough) for PF-03084014||Day 1 of Cycle 1, 2, 3, and 5|Due to study termination, no PK analyses were performed for this study.|||||
641673|NCT02299635|Secondary|Type of Notch Genomic Alterations in Participants With NA+ mTNBC|Type of notch genomic alterations identified by NGS assay in patients with NA+ mTNBC|2 years|Data for this outcome measure was not collected due to early termination of this study.|||||
641674|NCT02299635|Secondary|Overall Survival (OS) in Participants With NA+ or NA mTNBC|OS was the duration from enrollment to death. For participants who are alive, overall survival was censored at the last contact.|2 years|Data for this outcome measure was not collected due to early termination of this study.|||||
641675|NCT02299635|Secondary|One-Year Survival Probability in Participants With NA+ or NA mTNBC|Overall survival (OS) status (alive or not) at 1 year after study entry. The the survival probability at 1 year was summarized as a product limit estimator based on the Kaplan-Meier method to account for censored events.|1 year|Data for this outcome measure was not collected due to early termination of this study.|||||
641676|NCT02299635|Secondary|Duration of Response (DR) in Participants With NA+ or NA mTNBC|Time from the first documentation of objective tumor response to objective tumor progression or death due to any cause. DR was calculated for the subgroup of patients with a confirmed objective tumor response. Objective Progression (PD): 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm.|2 years|Data for this outcome measure was not collected due to early termination of this study.|||||
641677|NCT02299635|Secondary|Progression-Free Survival (PFS) in Participants With NA+ or NA mTNBC|The period from study entry until disease progression, death, whichever occurred first as per RECIST version 1.1.|2 years|Data for this outcome measure was not collected due to early termination of this study.|||||
641692|NCT02298868|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Dizziness)|Proportion of patients with dizziness at any time during the 4 weeks of therapy|4 weeks of active therapy|||participants|||Number
641693|NCT02298868|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Nausea)|Proportion of patients with nausea at any time during the 4 weeks of therapy|4 weeks of active therapy|||participants|||Number
678086|NCT01601977|Secondary|Control of Nocturnal Hypoventilation|mean tcCO2|2 weeks|||kPa||Standard Deviation|Mean
641678|NCT02299635|Secondary|OR Rate in Participants With mTNBC Whose Tumors Tested Negative for Eenomic Alterations in Notch Receptor (NA-)|OR status based on assessment of confirmed CR or confirmed PR according to RECIST 1.1. CR: Complete disappearance of all target lesions with the exception of nodal disease and all target nodes decreased to normal size (short axis <10 mm). PR: >=30% decrease under baseline of the sum of diameters of all target measurable lesions. OR=CR+PR.|Cycle 3 Day 1, Cycle 5 Day 1, and every 6 weeks for subsequent cycles ntil disease progression, patient refusal for further follow up, or start of another anti-cancer treatment, whichever occurred first.|Data for this outcome measure was not collected due to early termination of this study.|||||
641679|NCT02299635|Primary|Objective Response (OR) Rate in Participants With Advanced Triple Receptor-Negative Breast Cancer (mTNBC) Harboring Activating Genomic Alterations in Notch Receptors (NA+)|OR status based on assessment of confirmed complete remission (CR) or confirmed partial remission (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1). CR: Complete disappearance of all target lesions with the exception of nodal disease and all target nodes decreased to normal size (short axis less than [<]10 millimeter [mm]). PR: Greater than or equal to (>=)30% decrease under baseline of the sum of diameters of all target measurable lesions. OR=CR+PR.|Cycle 3 Day 1, Cycle 5 Day 1, and every 6 weeks for subsequent cycles ntil disease progression, patient refusal for further follow up, or start of another anti-cancer treatment, whichever occurred first.|Data for this outcome measure was not collected due to early termination of this study.|||||
641680|NCT02299427|Primary|Simulated Behavior With Dogs on Standardized Objective Scale|Coded behavior in dollhouse simulation. Specifically, in 7 simulated scenarios using a dollhouse that included child and dog characters, furniture, yard, etc., children heard a scene and explained/used the dolls to act what would happen next. For example, the experimenter acted a child doll playing in the kitchen near dog food and the doll dog entered, saw the child, and approached the food bowl. The experimenter said, “[Child’s Name] is playing around in the kitchen near [Dog name’s] food. [Dog’s name] comes into the kitchen and sees [Child’s Name] near his/her food bowl making him/her upset and start to growl. What will happen next?” The task was coded using objective coding criteria to score the child’s response as safe (1 point), safe but not optimal (0.5 points), or unsafe (0 points). Scores across the 7 scenarios were summed to yield a single score; possible range = 0=7. Higher scores indicate better safety. Inter-rater reliability on 30% of the sample was good; kappa = .90.|post-intervention (about 2 weeks after pre-intervention assessment)|In the dog safety group, only children with known noncompliance were analyzed for this measure||units on a scale||Standard Deviation|Mean
641681|NCT02299427|Primary|Children's Behavior With Dogs on Standardized Objective Scale|Coded behavior using objective criteria during a semi-structured interaction with a live therapy dog. Specifically, we examined behavioral patterns for 15 tasks/activities/decisions the child made with the live dog. Sample tasks were when and how the child touched the dog, the extent to which the child was close or intimate to the dog, whether the child handled the dog’s toys, and whether the child interrupted the dog during its “rest time”. 7 of those hung together in factor analysis. Those 7 were standardized and then averaged to create the scale. It was transformed with linear transformation so all values are positive. Higher numbers indicate higher risk-taking. Theoretically the scale is 0-infinity; in practice most children scored between 0-4. The individual items had an average intercorrelation of .50 and Cronbach's alpha of .65.|post-intervention (about 2 weeks after pre-intervention assessment)|In the dog safety group, only children with known noncompliance were analyzed for this measure||units on a scale||Standard Deviation|Mean
641682|NCT02299349|Secondary|MS04 Equivalent Consumption|in hospital total MS04 equivalent consumption|1 day following surgery|||mg||Inter-Quartile Range|Median
641683|NCT02299349|Primary|Pain Scores (Visual Analog Pain Scores)|visual analog pain scores (scale 0=no pain; 10=worst pain imaginable)|1 day following surgery|||units on a scale||Standard Deviation|Mean
641684|NCT02299258|Secondary|Adverse Events|bleeding, abdominal pain|up to 5 years|||participants|||Number
641685|NCT02299258|Primary|Efficiency of Stents|number of participants considered having efficacious outcome. Efficacy is defined by Ingrowth + overgrowth in this study|up to 5 years|||participants|||Number
641686|NCT02299076|Primary|Outcome of Smoking Cessation Intervention|Quit levels for the intervention will be higher relative to the control arm. Quit level is defined as a participant who progresses to the stage in the tobacco cessation program where they quit smoking. The quit stages are levels 4 and 5 of the tobacco cessation program.|Every 30 days for up to 6 months post-enrollment|||Participants|||Count of Participants
641687|NCT02299076|Primary|Average Number of Completed Sessions Per Participant|Engagement rates for the intervention will be higher relative to the control arm. Engagement is measured by the number of complete tobacco cessation sessions per participant.|Every 30 days for up to 6 months post-enrollment|||Average Number of Sessions|Sessions|Inter-Quartile Range|Mean
641688|NCT02298868|Secondary|Change in Severity of Muscle Cramps After Washout Period|Subjects undertook a muscle cramp questionnaire prior to treatment that measured severity on a 0-10 analog scale (0 is no pain, 10 is most severe pain) and repeated this measure at the end of baclofen therapy (end of week 4). Subjects then underwent a 1 week taper of baclofen and a subsequent two week washout period. At the end of the washout period (end of week 7) the subjects underwent a final muscle cramp questionnaire to reassess severity of muscle cramps. This was then compared to the end of therapy severity to document the increase in muscle cramps after stopping baclofen. (week 7 result - week 4 result)|End of treatment (week 4) to end of washout (week 7)|||units on a scale||Standard Deviation|Mean
641689|NCT02298868|Secondary|Change in Frequency of Muscle Cramps After Washout Period|Subjects undertook a muscle cramp questionnaire prior to treatment that measured frequency in the number of days in a week that a subject experienced muscle cramps and repeated this measure at the end of baclofen therapy (end of week 4). Subjects then underwent a 1 week taper of baclofen and a subsequent two week washout period. At the end of the washout period (end of week 7) the subjects underwent a final muscle cramp questionnaire to reassess frequency of muscle cramps. This was then compared to the end of therapy frequency to document the increase in muscle cramps after stopping baclofen. (week 7 result - week 4 result)|End of treatment (week 4) to end of washout (week 7)|||days/week||Standard Deviation|Mean
641690|NCT02298868|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Somnolence)|Proportion of patients with somnolence at any time during the 4 weeks of therapy|4 weeks of active therapy|||participants|||Number
683439|NCT01528332|Secondary|Change From Treatment in VAS Pain Intensity at Follow up||Treatment (day +1 to +14) to Follow-up (up to day +42)||||||
641694|NCT02298868|Secondary|Efficacy of Baclofen to Change Severity of Muscle Cramps in Patients With Cirrhosis After 4 Weeks of Therapy|Patients undertook a muscle cramp questionnaire prior to treatment that measured severity in a 0-10 analog scale (0 is no pain and 10 is most severe pain). These measures were repeated after 4 weeks of therapy and the difference was assessed (4 weeks of therapy-Baseline).|Baseline to end of 4 weeks of therapy|||units on a scale||Standard Deviation|Mean
641695|NCT02298868|Secondary|Efficacy of Baclofen to Change Frequency of Muscle Cramps in Patients With Cirrhosis at the End of 4 Weeks of Therapy|Patients undertook a muscle cramp questionnaire prior to treatment that measured frequency in the number of days in a week that a subject experienced muscle cramps. This measures was repeated after 4 weeks of therapy and reported as the mean decrease in frequency of muscle cramps (4 weeks of therapy-Baseline).|Baseline to 4 weeks of therapy|||days/week||Standard Deviation|Mean
641696|NCT02298868|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Headache)|Proportion of patients with headache at any time during the 4 weeks of therapy|4 weeks of active therapy|||participants|||Number
641697|NCT02298842|Secondary|Platelet Morphology|Quantifies (via phase-contrast light microscopy) the morphological changes of platelets coincident with the full range of platelet activation profile (Units: Kunicki score; Range is 0 to 400). Higher values represent healthier platelets.|Day 7|The Full Analysis Set (FAS) was used to examine the primary and secondary endpoints.The FAS consisted of all products where the corresponding Test and Control values for the primary endpoint did not meet any of the protocol analysis exclusion criteria.||score on a scale||Standard Deviation|Mean
641698|NCT02298842|Secondary|Percent of Platelets Exhibiting Hypotonic Shock Response|Measures the ability of platelets to recover their volume after being exposed to a hypotonic environment (Units: % Recovery). Higher value is considered to indicate better platelet quality.|Day 7|The Full Analysis Set (FAS) was used to examine the primary and secondary endpoints.The FAS consisted of all products where the corresponding Test and Control values for the primary endpoint did not meet any of the protocol analysis exclusion criteria.||% of hypotonic shock response||Standard Deviation|Mean
641699|NCT02298842|Secondary|Percent of Extent of Shape Change|Measures the proportion of platelets that have a discoid morphology (Units: %). Higher value is considered to indicate better platelet quality. Higher value is considered to indicate better platelet quality.|Day 7|The Full Analysis Set (FAS) was used to examine the primary and secondary endpoints.The FAS consisted of all products where the corresponding Test and Control values for the primary endpoint did not meet any of the protocol analysis exclusion criteria.||% of extent of shape change||Standard Deviation|Mean
641700|NCT02298842|Secondary|Percent of Platelets Activated as Measured by P-selectin|Flow cytometric detection of platelet P-selectin expression (Units: %). Lower value is considered to indicate better platelet quality.|Day 7|The Full Analysis Set (FAS) was used to examine the primary and secondary endpoints.The FAS consisted of all products where the corresponding Test and Control values for the primary endpoint did not meet any of the protocol analysis exclusion criteria.||Percent of Platelets Activated||Standard Deviation|Mean
641701|NCT02298842|Secondary|Platelet Morphology|Quantifies (via phase-contrast light microscopy) the morphological changes of platelets coincident with the full range of platelet activation profile (Units: Kunicki score; Range is 0 to 400). Higher values represent healthier platelets.|Day 5|The Full Analysis Set (FAS) was used to examine the primary and secondary endpoints.The FAS consisted of all products where the corresponding Test and Control values for the primary endpoint did not meet any of the protocol analysis exclusion criteria.||scores on a scale||Standard Deviation|Mean
641702|NCT02298842|Secondary|Percent of Platelets Exhibiting Hypotonic Shock Response|Measures the ability of platelets to recover their volume after being exposed to a hypotonic environment (Units: % Recovery). Higher value is considered to indicate better platelet quality.|Day 5|The Full Analysis Set (FAS) was used to examine the primary and secondary endpoints.The FAS consisted of all products where the corresponding Test and Control values for the primary endpoint did not meet any of the protocol analysis exclusion criteria.||% of hypotonic shock response||Standard Deviation|Mean
641703|NCT02298842|Secondary|Percent of Extent of Shape Change|Measures the proportion of platelets that have a discoid morphology (Units: %). Higher value is considered to indicate better platelet quality.|Day 5|The Full Analysis Set (FAS) was used to examine the primary and secondary endpoints.The FAS consisted of all products where the corresponding Test and Control values for the primary endpoint did not meet any of the protocol analysis exclusion criteria.||% extent of shape change||Standard Deviation|Mean
641704|NCT02298842|Secondary|Percent of Platelets Activated as Measured by P-selectin|Flow cytometric detection of platelet P-selectin expression (Units: %). Lower value is considered to indicate better platelet quality.|Day 5|The Full Analysis Set (FAS) was used to examine the primary and secondary endpoints.The FAS consisted of all products where the corresponding Test and Control values for the primary endpoint did not meet any of the protocol analysis exclusion criteria.||Percent of Platelets Activated||Standard Deviation|Mean
641705|NCT02298842|Primary|pH of Platelets at Day 7|The primary endpoint for this study is pH of platelets stored in InterSol at Day 7. The FDA acceptance criteria for pH is 95% of products have pH >6.2 at 22 degrees C with 95% confidence interval. A sample size of 60 subjects was chosen for the study to meet the acceptance criteria with 0 failures out of 60 Test products.|Day 7|The Full Analysis Set (FAS) was used to examine the primary and secondary endpoints.The FAS consisted of all products where the corresponding Test and Control values for the primary endpoint did not meet any of the protocol analysis exclusion criteria.||pH||Standard Deviation|Mean
641706|NCT02298842|Primary|pH of Platelets at Day 5|The primary endpoint for this study is pH of platelets stored in InterSol at Day 5. The FDA acceptance criteria for pH is 95% of products have pH >6.2 at 22 degrees C with 95% confidence interval. A sample size of 60 subjects was chosen for the study to meet the acceptance criteria with 0 failures out of 60 Test products.|Day 5|The Full Analysis Set (FAS) was used to examine the primary and secondary endpoints.The FAS consisted of all products where the corresponding Test and Control values for the primary endpoint did not meet any of the protocol analysis exclusion criteria.||pH||Standard Deviation|Mean
641728|NCT02295020|Primary|Synovial Fluid Analysis (IL-8)|Interleukine 8 in Synovial fluid analysis|Week 8 - day 0|Discrepancies between participants flow chart and number of participants analyzed is due to either synovial fluid not present in the knee or not sufficient to be analyzed.||pg/mL||Full Range|Median
683440|NCT01528332|Secondary|Change From Baseline in VAS Pain Intensity at Follow up||Baseline (day -7 to 1) to Follow-up (up to day +42)||||||
641707|NCT02298361|Primary|Proportion of Patients Who Lost Medicaid Coverage|Proportion of participants who lost Medicaid coverage after a period of insurance. Assessed using state administrative records linked to EHR data; this outcome was assessed among the subset of participants with a Medicaid ID (and thus could be linked between the two data sources) and who had partial coverage during the study period (i.e., patients with 100% coverage were not 'eligible' to lose coverage).|6 months pre- through 16 months post-tool implementation|||participants|||Number
641708|NCT02298361|Primary|Proportion of Patients Who Gained Medicaid Coverage|Proportion of participants who gained Medicaid coverage after a period of uninsurance. Assessed using state administrative records linked to EHR data; this outcome was assessed among the subset of participants with a Medicaid ID (and thus could be linked between the two data sources) and who had partial coverage during the study period (i.e., patients with 100% coverage were not 'eligible' to gain coverage).|6 months pre- through 16 months post-tool implementation|||participants|||Number
641709|NCT02298361|Primary|Percent of Study Period Covered by Medicaid|Percent of total days in 22-month assessment period that each child was covered by Medicaid insurance. Assessed using state administrative records linked to EHR data; this outcome was assessed among the subset of participants with a Medicaid ID (and thus could be linked between the two data sources).|6 months pre- through 16 months post-tool implementation|||participants|||Number
641710|NCT02298192|Secondary|Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes|An episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.|Week 0-32|"Safety Analysis Set (SAS): Included all subjects receiving at least one dose of trial product. Subjects contributed to the evaluation “as treated. One subject in the IDegLira (1WT) arm did not contribute to the analysis for this endpoint."||Number of episodes|||Number
641711|NCT02298192|Secondary|HbA1c Below or Equal to 6.5%|Responders to HbA1c below or equal to 6.5% after 32 weeks of treatment.|Week 0, week 32|Full analysis set (FAS) included all randomised subjects. 20 subjects in the IDegLira (1WT) and 10 subjects in the IDegLira arm did not contribute to the analysis for this endpoint.||particpants|||Number
641712|NCT02298192|Secondary|HbA1c Below 7.0%|Responders to HbA1c below 7% after 32 weeks of treatment.|Week 0, week 32|Full analysis set (FAS) included all randomised subjects. 20 subjects in the IDegLira (1WT) and 10 subjects in the IDegLira arm did not contribute to the analysis for this endpoint.||participants|||Number
641713|NCT02298192|Primary|Change From Baseline in HbA1c|Change in glycosylated haemoglobin A1c (HbA1c) (%) from baseline after 32 weeks of treatment.|Week 0, week 32|Full analysis set (FAS) included all randomised subjects. 20 subjects in the IDegLira (1WT) and 10 subjects in the IDegLira arm did not contribute to the analysis for this endpoint.||percentage||Standard Deviation|Mean
641714|NCT02297841|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability||24, 48, and 72 hours after patch application|||participants|||Number
641715|NCT02297308|Secondary|Bleeding Complications at the Access Site|VARC-2 defined vascular access site bleeding complications i.e. minor, major or life threatening bleeding|within 30 days of TAVI procedure|||participants|||Number
641716|NCT02297308|Primary|Vascular Access Site Complications|Rate of VARC-2 defined vascular complications within 30 days of TAVI.|withn 30 days of TAVI procedure|||participants|||Number
641717|NCT02296931|Primary|Error in the Total Volume Dispensed and Flow Rate|This is the error value for the volume dispensed by the AutoSyp device relative to the volume intended to be dispensed. Preeclamptic subjects received an initial loading dose followed by a maintenance dose. The loading dose had a flow rate of 60 mL/hr and delivered 20 mL in a single 20 mL syringe. The maintenance dose was 5 mL/hr and dispensed 120 mL total through two 60 mL syringes. The healthy subjects experienced variable flow rates and dispensed volumes, so they do not have the same variables as the pre-eclamptic pregnant women in the outcome data tables below. Because of these differences in dosing the two arms of the study, healthy women and preeclamptic women have different outcome measure data.|1 day visit|||percentage of error||Full Range|Mean
641718|NCT02295774|Primary|Gamma H2AX Histone Levels in Colonic Biopsy During Standard White Light Colonoscopy and Colonoscopy for Which Methylene Blue MMX Was Taken Prior to Initiating the Colonoscopy|Assay of gamma H2AX histone phosphorylation in biopsy samples collected during colonoscopy.|2 weeks|FAS = 10||number of positive biopsies|||Number
641719|NCT02295644|Primary|Intraoral Muscle Temperature|Using digital thermometer on buccal mucosa, degrees celsius.|Immediately before and after the intervention, difference used.|||degrees Celsius, post minus pre||Standard Deviation|Mean
641720|NCT02295644|Primary|Pressure Pain Threshold of the Masseter Muscle|Measuring pressure pain threshold using digital algometer|Immediately before and after the intervention, difference used.|||Kpa/Cm^2||Standard Deviation|Mean
641721|NCT02295644|Primary|Self Report of Pain|Pain intensity measurement scale from 0 to 10, 0 is no pain, 10 is the worst pain ever|Immediately before and after the intervention, difference used.|||Scores on pain intensity scale||Standard Deviation|Mean
641722|NCT02295020|Primary|Visual Analog Scale|identifies pain level|Day 0 and Week 8|The outcome was not measured as KOOS was measured as the only patient reported outcome.|||||
641723|NCT02295020|Primary|WOMAC|assess pain, stiffness, and physical function measured by Western Ontario and McMaster universities Osteoarthritis Index|Day 0 and Week 8|The outcome was not measured as KOOS was measured as the only patient reported outcome.|||||
641724|NCT02295020|Primary|Oxford Knee Score||Day 0 and Week 8|The outcome was not measured as KOOS was measured as the only patient reported outcome.|||||
641725|NCT02295020|Primary|Synovial Fluid Analysis (MCP - 1)|Monocyte chemotactic protein-1 - 1|Week 8 -day 0|Discrepancies between participants flow chart and number of participants analyzed is due to either synovial fluid not present in the knee or not sufficient to be analyzed.||pg/mL||Full Range|Median
641726|NCT02295020|Primary|Synovial Fluid Analysis (MIP - 1alpha)|Macrophage Inflammatory Proteins - 1alpha|Week 8 - day 0|Discrepancies between participants flow chart and number of participants analyzed is due to either synovial fluid not present in the knee or not sufficient to be analyzed.||pg/mL||Full Range|Median
641727|NCT02295020|Primary|Synovial Fluid Analysis (TNF-alpha)|Tumor necrosis factor - alpha in Synovial fluid analysis|Week 8 - day 0|Discrepancies between participants flow chart and number of participants analyzed is due to either synovial fluid not present in the knee or not sufficient to be analyzed.||pg/mL||Full Range|Median
641729|NCT02295020|Primary|Synovial Fluid Analysis (IL-6)|Interleukine 6 in Synovial fluid analysis|Week 8 - day 0|Discrepancies between participants flow chart and number of participants analyzed is due to either synovial fluid not present in the knee or not sufficient to be analyzed.||pg/mL||Full Range|Median
641730|NCT02295020|Primary|KOOS - QOL|Value at 8 weeks - value at day 0|Week 8 - day 0|Discrepancies between participants flow chart and number of participants analyzed is due to patients not filling out the survey.||pg/mL||95% Confidence Interval|Least Squares Mean
641731|NCT02295020|Primary|KOOS - Sport/Rec|Value at 8 weeks - value at day 0|Week 8 - day 0|Discrepancies between participants flow chart and number of participants analyzed is due to patients not filling out the survey.||units on a scale||95% Confidence Interval|Least Squares Mean
641732|NCT02295020|Primary|KOOS - ADL|Value at 8 weeks - value at day 0|week 8 - day 0|Discrepancies between participants flow chart and number of participants analyzed is due to patients not filling out the survey.||units on a scale||95% Confidence Interval|Least Squares Mean
641733|NCT02295020|Primary|KOOS - Symptoms|Value at 8 weeks - value at day 0|Week 8 - Day 0|Discrepancies between participants flow chart and number of participants analyzed is due to patients not filling out the survey.||units on a scale||95% Confidence Interval|Least Squares Mean
641734|NCT02295020|Primary|KOOS - Pain|Value at 8 weeks - value at day 0|Week 8- Day 0|Discrepancies between participants flow chart and number of participants analyzed is due to patients not filling out the survey.||units on a scale||95% Confidence Interval|Least Squares Mean
641735|NCT02294773|Other Pre-specified|Pregnancy Rate Per Body Mass Index Category||Up to cycle day 35|||pregnancies per cycle|||Number
641736|NCT02294773|Other Pre-specified|Pregnancy Rate Per Semen Morphology Score|Comparison of pregnancy rate based on semen morphology of <4% vs >4% normal morphology scores.|Up to cycle day 35|||pregnancies per cycle|||Number
641737|NCT02294773|Other Pre-specified|Pregnancy Rate Per Female Partner Age|Pregnancy rate will be compared between patients <35 and >35 at time of study entry.|Up to cycle day 35|||pregnancies per cycle|||Number
641738|NCT02294773|Other Pre-specified|Per Cycle Pregnancy Rate Based on Infertility Diagnosis||Up to cycle day 35|||pregnancies per cycle|||Number
641739|NCT02294773|Primary|Number of Pregnancies Achieved Per Menstrual Cycle.||Up to 3 months|||pregnancies per cycle|||Number
641740|NCT02294734|Secondary|Number of Participants With Treatment Failures|Treatment failure types are presented as: recurrent exacerbations, prolonged treatment of current exacerbation (beyond 14 days), additional treatment with systemic / oral corticosteroids and / or antibiotics, and requirement for invasive mechanical ventilation.|13 weeks|ITT Population||Participants|||Number
641741|NCT02294734|Secondary|Questionnaires CAT and MMRC Scale at Baseline, Day 28 and Day 84|The chronic obstructive pulmonary disease (COPD) assessement test (CAT) and Modified Medical Research Council (MMRC) Dyspnea Scale were completed at the indicated timepoints: Baseline, Day 28 and Day 84. CAT and MMRC scales are prestned as: 1.I never cough/I cough all the time 2.I have no phelgm in my chest at all/My chest is completely full of phelgm 3. My chest does not feel tight at all/My chest feels very tight 4.Walk up hilll or stairs not breathless/Walk up hill or stairs very breathless 5. Not limited doing any home activities/Very limited doing any home activities 6. Confident leaving home/No confident leaving home 7. I sleep soundly/I don't sleep soundly because of my lung condition and 8. I have lots of energy/I have no energy at all. Baseline is defined as the assessment on Day 1. Score 0 indicates not troubled with breathlessness to 4:too breathless. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Day 28 and Day 84|ITT Population||Scores on a scale||Standard Deviation|Mean
641742|NCT02294734|Secondary|Change From Baseline in Specific Conductance (sGaw) After 28 Days and After 84 Days of Treatment|Baseline is defined as the assessment on Day 2 and change from Baseline is the post-Baseline value minus Baseline value. Change from Baseline data is presented for Day 28 and Day 84. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).Note: values mentioned as 95% confidence interval below are in fact values of 95% Credible Interval.|Baseline, Day 28 and Day 84|ITT Population||1/KPA*S||95% Confidence Interval|Median
641743|NCT02294734|Secondary|Change From Baseline in Specific Resistance (sRaw) After 28 Days and After 84 Days of Treatment|sRaw is the measure of specific resistance. Baseline is defined as the assessment on Day 2 and change from Baseline is the post-Baseline value minus Baseline value. Change from Baseline data is presented for Day 28 and Day 84. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Day 28 and Day 84|ITT Population||KPa*s||Standard Deviation|Mean
641744|NCT02294734|Secondary|Change From Baseline in Functional Residual Capacity After 28 Days and After 84 Days of Treatment|Functional residual capacity is the volume of air present in the lungs at the end of passive expiration. Baseline is defined as the assessment on Day 2 and change from Baseline is the post-Baseline value minus Baseline value. Change from Baseline data is presented for Day 28 and Day 84. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Day 28 and Day 84|ITT Population||L||Standard Deviation|Mean
641745|NCT02294734|Secondary|Change From Baseline in Residual Volume After 28 Days and After 84 Days of Treatment|Residual volume is a lung volume representing the amount of air left in the lungs after a forced exhalation. Baseline is defined as the assessment on Day 2 and change from Baseline is the post-Baseline value minus Baseline value. Change from Baseline data is presented for Day 28 and Day 84. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Note: values mentioned as 95% confidence interval below are in fact values of 95% credible interval.|Baseline, Day 28 and Day 84|ITT Population||L||95% Confidence Interval|Median
641746|NCT02294734|Secondary|Change From Baseline in Total Lung Capacity (TLC) After 28 Days and After 84 Days of Treatment|TLC is the maximum amount of air that can fill the lungs. Baseline is defined as the assessment on Day 2 and change from Baseline is the post-Baseline value minus Baseline value. Change from Baseline data is presented for Day 28 and Day 84. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Note: values mentioned as 95% confidence interval below are in fact values of 95% credible interval.|Baseline, Day 28 and Day 84|ITT Population||L||95% Confidence Interval|Median
641942|NCT02288273|Primary|Change in 24-hour Mean Weighted Glucose|Change in 24-hour mean weighted glucose from baseline (Day -1/1) to Day 6 of Week 4 (Day 27/28) and to Day 6 of Week 10 (Day 69/70).|Day 27/28|||(mg/dL)|(mg/dL)|Standard Deviation|Mean
641747|NCT02294734|Secondary|Percent Change From Baseline in Diffusion Capacity (DLco, Kco) After 28 Days and After 84 Days of Treatment|DLco is diffusing capacity o f the lungs for carbon monoxide and is defined as the extent to which oxygen passes from the air sacs of the lungs into the blood. KCO is the carbon monoxide transfer coefficient. It is an index of the efficiency of alveolar transfer of carbon monoxide. Baseline is defined as the assessment on Day 2 and percent change from Baseline is the post-Baseline value minus Baseline value/100. Change from Baseline data is presented for Day 28 and Day 84. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Day 28 and Day 84|ITT Population||Percent||Standard Deviation|Mean
641748|NCT02294734|Secondary|Changes From Baseline in Peak Expiratory Flow (PEF) Measured Daily|PEF is the maximal flow (or speed) achieved during the maximally forced expiration initiated at full inspiration. Baseline is defined as the assessment on Day 1 and change from Baseline is the post-Baseline value minus Baseline value. Change from Baseline data is presented for Day 28 and Day 84.Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Day 28, and Day 84|ITT Population||L/min||Standard Deviation|Mean
641749|NCT02294734|Secondary|Changes From Baseline in Forced Expiratory Volume in One Second (FEV1) Measured Daily|FEV1 is the volume of air that can forcibly be blown out in one second. A triplicate FEV1 measurement were taken daily in the morning before dose administration. Baseline is defined as the assessment on Day 1 and change from Baseline is the post-Baseline value minus Baseline value. Change from Baseline data is presented for Day 28 and Day 84.Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Day 28, and Day 84|ITT Population||mL||Standard Deviation|Mean
641750|NCT02294734|Secondary|Trough Concentration After 12 Days, 28 Days, 56 Days and 84 Days of Treatment|Trough concentrations are presented for Pre-dose Day 12, Pre-dose Day 28, Pre-dose Day 56, and Pre-dose Day 84. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Pre-dose Day 12, Day 28, Day 56, and Day 84|PK Population||pg/mL||Standard Deviation|Mean
641751|NCT02294734|Secondary|Day 1 Plasma Concentration up to 24 Hours (Hrs) Post-dose|Plasma samples were collected at pre-dose, 5 minutes (min), 3 hrs, and 24 hrs post-dose on Day 1. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Pharmacokinetic (PK) Population: all participants in the Safety Population for whom a PK sample was obtained and analyzed. Safety Population comprises of all participants who were randomized.|Pre-dose, 5 min, 3 hrs and 24 hrs|Pharmacokinetic (PK) Population||pg/mL||Standard Deviation|Mean
641752|NCT02294734|Secondary|Number of Participants With Abnormal 12-lead Electrocardiogram (ECG)|12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QT interval corrected using the Fridericia's formula (QTcF). Clinically non-significant (CN) and Clinically significant (CS) abnormal ECG measurements are presented for Day 1, Day 12, Day 28, Day 56, Day 84, follow-up/Early withdrawal and at any visit post-baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Day 1, Day 12, Day 28, Day 56, Day 84 and at follow-up (approximately 100 days)|All Subject Population||Participants|||Number
641753|NCT02294734|Secondary|Number of Participants With Abnormal Vital Signs|Vital signs included high and low diastolic and systolic blood presure (BP), and high and low heart rate (HR). Vital signs outside the range of potential clinical importance are presented at the indicated timepoints: Day 1, Day 12, Day 28, Day 56, Day 84, follow-up/Early withdrawal and at any visit post-baseline . Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Day 1, Day 12, Day 28, Day 56, Day 84 and at follow-up (approximately 100 days)|All Subject Population||Participants|||Number
641754|NCT02294734|Secondary|Number of Participants With Abnormal Clinical Chemistry Parameters|Clinical Chemistry parameters included Alanine Amino Transferase (ALT), Albumin, Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Calcium (Ca), Glucose, Potassium (K), Sodium (Na), and Total Bilirubin (TBL) at the indicated timepoints: Day 1, Day 12, Day 28, Day 56, Day 84, and at follow-up/Early withdrawal. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Day 1, Day 12, Day 28, Day 56, Day 84 and at follow-up (approximately 100 days)|All Subject Population||Participants|||Number
641755|NCT02294734|Secondary|Number of Participants With Abnormal Hematology Parameters|Hematology parameter included Hematocrit (HCT), Hemoglobin (HB), Lymphocytes (LC), Platelet Count (PC), Total Neutrophils (TN), and White Blood Cell (WBC) count at the indicated timepoints: Day 1, Day 12, Day 28, Day 56, Day 84, and at follow-up/Early withdrawal. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Day 1, Day 12, Day 28, Day 56, Day 84 and at follow-up (approximately 100 Days)|All Subjects Population||Participants|||Number
641756|NCT02294734|Secondary|Number of Participants With Adverse Events (AE)|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events were collected from the start of study treatment until the follow-up contact.|From start of IP through the Study Phase (84 days post-dose) (assessed up to follow-up duration of approximately 100 days)|All Subjects Population: all randomized participants who received at least one dose of study treatment.||Participants|||Number
641757|NCT02294734|Secondary|Change From Baseline in Imaging Trachea Length/Diameter After 12 Days of Treatment and After 28 Days of Treatment|Imaging trachea length/diameter was derived from HRCT to evaluate the effect of once daily inhaled dose of GSK2269557 on lung parameters. TLC is the volume in the lungs at maximal inflation and FRC is the volume in the lungs at the end-expiratory position. The Baseline for the assessment on Day 12 and Day 28 is the Screening value. Change from Baseline is the post-Baseline value minus the Baseline value. The change from Baseline data is presented for Day 12 and Day 28 for trachea length/diameter. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Day 12 and Day 28|ITT Population excluding the subject with a pacemaker.||ratio||Standard Deviation|Mean
641758|NCT02294734|Secondary|Change From Baseline in Imaging Trachea Length and Diameter After 12 Days of Treatment and After 28 Days of Treatment|Imaging trachea length and diameter was derived from HRCT to evaluate the effect of once daily inhaled dose of GSK2269557 on lung parameters. TLC is the volume in the lungs at maximal inflation and FRC is the volume in the lungs at the end-expiratory position. The Baseline for the assessment on Day 12 and Day 28 is the Screening value. Change from Baseline is the post-Baseline value minus the Baseline value. The change from Baseline data is presented for Day 12 and Day 28 for trachea length and diameter. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Day 12 and Day 28|ITT Population excluding the subject with a pacemaker.||Millimeter (mm)||Standard Deviation|Mean
641759|NCT02294734|Secondary|Change From Baseline in Lung Lobar Volumes Measured at FRC and TLC Scan Conditions, Presented in Longitudinal Scan Types, Measured in 5 Lobes and 5 Regions at Day 12 and Day 28|Change from Baseline in lung lobar volumes was measured at functional residual volume (FRC) and total lung capacity (TLC) scan conditions. Data was collected at longitudinal time points: Day 12 & Day 28. At each time point it was measure at 5 lobes (RUL, LUL, RML, RLL & LLL) and 5 Regions (Upper, Lower, Central, Distal & Total). For longitudinal time points the baseline is screening. Change from baseline is the post-Baseline value minus the Baseline value. Only particpants available at the specified time point were analysed (represented by n=X1, X2 in the category title).|Baseline, Day 12 and Day 28|ITT Population excluding the subject with a pacemaker.||L||95% Confidence Interval|Geometric Mean
641760|NCT02294734|Secondary|Change From Baseline in Imaging Specific Airways Resistance: siRaw Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28|siRaw was derived from HRCT to evaluate the effect of once daily inhaled dose of GSK2269557 on lung parameters. It was measured at functional residual volume (FRC) and total lung capacity (TLC). Data was collected at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (RUL, LUL, RML, RLL & LLL) and 5 Regions (Upper, Lower, Central, Distal & Total). For SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only particpants available at the specified time point were analysed (represented by n=X1, X2 in the category title).|Baseline, Day 12 and Day 28|ITT Population excluding the subject with a pacemaker.||Kpa*s||95% Confidence Interval|Geometric Mean
641761|NCT02294734|Secondary|Change From Baseline in Imaging Airways Resistance ( iRaw) Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28|iRaw was derived from HRCT to evaluate the effect of once daily inhaled dose of GSK2269557 on lung parameters. It was measured at functional residual volume (FRC) and total lung capacity (TLC). Data was collected at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (RUL, LUL, RML, RLL & LLL) and 5 Regions (Upper, Lower, Central, Distal & Total). For SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only particpants available at the specified time point were analysed (represented by n=X1, X2 in the category title).|Baseline, Day 12 and Day 28|ITT Population excluding the subject with a pacemaker.||Kilopascal (Kpa)*s/L||95% Confidence Interval|Geometric Mean
641762|NCT02294734|Secondary|Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28|iVaw was derived from HRCT to evaluate the effect of once daily inhaled dose of GSK2269557 on lung parameters. Data was collected at longitudinal time points: Screening, Day 12 & Day 28 and at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (RUL, LUL, RML, RLL & LLL) and 5 Regions (Upper, Lower, Central, Distal & Total). For longitudinal time points and SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only particpants available at the specified time point were analysed (represented by n=X1, X2 in the category title).|Baseline, Day 12 and Day 28|ITT Population excluding the subject with a pacemaker.||Milliliter (mL)||95% Confidence Interval|Geometric Mean
641763|NCT02294734|Primary|Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28|siVaw is a measure of the volume in an individual’s airway corrected for their lobar volume derived from the high resolution computed tomography (HRCT). It was measured at functional residual volume (FRC) and total lung capacity (TLC). Data was collected at longitudinal time points: Screening, Day 12 & Day 28 and at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (RUL, LUL, RML, RLL & LLL) and 5 Regions (Upper, Lower, Central, Distal & Total). For longitudinal time points and SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only particpants available at the specified time point were analysed (represented by n=X1, X2 in the category title).|Baseline, Day 12 and Day 28|Intention to Treat (ITT) Population excluding the subject with a pacemaker.||Milliliter/Liter (mL/L)||95% Confidence Interval|Geometric Mean
641764|NCT02294682|Secondary|Number of Participants With Abnormal Urinalysis Dipstick Results|Dipstick urinalysis was done for glucose, ketones, occult blood, protein, potential hydrogen (pH) and specific gravity at Baseline visit Day 1 (pre-dose) and Test-of-Cure visit (Day 4 to 8). Results were presented as negative (normal) or other findings reported only if observed under microscopic examination trace, 1+, 2+, 3+, 4+ and 5+ glucose, ketones, occult blood and protein. pH results were categorized as per their pH values. Baseline was defined as the study assessment on Day 1 (pre-dose). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline visit and Test-of-Cure visit (Day 4 to 8)|Safety Population||Participants|||Number
641765|NCT02294682|Secondary|Change From Baseline in Erythrocytes Mean Corpuscular Volume at Test-of-Cure Visit (Day 4 to 8)|Blood samples were collected at Baseline Day 1 (pre-dose) and at TOC visit (Day 4 to 8) to evaluate erythrocytes mean corpuscular volume. Baseline was defined as the study assessment on Day 1 (pre-dose). Change from Baseline was calculated as value obtained at TOC Visit minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline visit and Test-of-Cure visit (Day 4 to 8)|Safety Population||Femtoliters||Standard Deviation|Mean
641766|NCT02294682|Secondary|Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin at Test-of-Cure Visit (Day 4 to 8)|Blood samples were collected at Baseline Day 1 (pre-dose) and at TOC visit (Day 4 to 8) to evaluate erythrocytes mean corpuscular hemoglobin. Baseline was defined as the study assessment on Day 1 (pre-dose). Change from Baseline was calculated as value obtained at TOC Visit minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline visit and Test-of-Cure visit (Day 4 to 8)|Safety Population||Picograms||Standard Deviation|Mean
641767|NCT02294682|Secondary|Change From Baseline in Erythrocytes at Test-of-Cure Visit (Day 4 to 8)|Blood samples were collected at Baseline Day 1 (pre-dose) and at TOC visit (Day 4 to 8) to evaluate erythrocytes (red blood cell count). Baseline was defined as the study assessment on Day 1 (pre-dose). Change from Baseline was calculated as value obtained at TOC visit minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline visit and Test-of-Cure visit (Day 4 to 8)|||10^12/L||Standard Deviation|Mean
641768|NCT02294682|Secondary|Change From Baseline in Chloride, Calcium, Glucose, Potassium, Sodium and Urea at Test-of-Cure Visit (Day 4 to 8)|Blood samples were collected at Baseline Day 1.(pre-dose) and at TOC visit (Day 4 to 8) to evaluate chloride, calcium, glucose, potassium, sodium and urea (blood urea nitrogen). Baseline was defined as the study assessment on Day 1 (pre-dose). Change from Baseline was calculated as value obtained at TOC visit minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline visit and Test-of-Cure visit (Day 4 to 8)|Safety Population||Millimole (MMOL)/L||Standard Deviation|Mean
641769|NCT02294682|Secondary|Change From Baseline in Alanine Aminotransferase, Aspartate Aminotransferase and Alkaline Phosphatase at Test-of-Cure Visit (Day 4 to 8)|Blood samples were collected at Baseline Day 1.(pre-dose) and at TOC visit (Day 4 to 8) to evaluate alanine aminotransferase, aspartate aminotransferase and alkaline phosphatase. Baseline was defined as the study assessment on Day 1 (pre-dose). Change from Baseline was calculated as value obtained at TOC visit minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline visit and Test-of-Cure visit (Day 4 to 8)|Safety Population||International units (IU)/ L||Standard Deviation|Mean
641770|NCT02294682|Secondary|Change From Baseline in Bilirubin, Direct Bilirubin and Creatinine at Test-of-Cure Visit (Day 4 to 8)|Blood samples were collected at Baseline Day 1 (pre-dose) and at TOC visit (Day 4 to 8) to evaluate bilirubin, direct bilirubin and creatinine. Baseline was defined as the study assessment on Day 1 (pre-dose). Change from Baseline was calculated as value obtained at TOC visit minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline visit and Test-of-Cure visit (Day 4 to 8)|Safety Population||Micromole (UMOL)/ L||Standard Deviation|Mean
641771|NCT02294682|Secondary|Change From Baseline in Lymphocyte, Monocyte, Neutrophil Basophil, Eosinophil, Leukocyte and Platelet Count at Test-of-Cure Visit (Day 4 to 8)|Blood samples were collected at Baseline Day 1 (pre-dose) and at TOC visit (Day 4 to 8) to evaluate neutrophil, lymphocyte, basophil, eosinophil, monocyte, leukocyte and platelet count. Baseline was defined as the study assessment on Day 1 (pre-dose). Change from Baseline was calculated as value obtained at TOC visit minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline visit and Test-of-Cure visit (Day 4 to 8)|Safety Population||10^9 cells/L||Standard Deviation|Mean
641772|NCT02294682|Secondary|Change From Baseline in Hematocrit at Test-of-Cure Visit (Day 4 to 8)|Blood samples were collected at Baseline Day 1 (pre-dose) and at TOC visit (Day 4 to 8) to evaluate hematocrit. Baseline was defined as the study assessment on Day 1 (pre-dose). Change from Baseline was calculated as value obtained at TOC visit minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline visit and Test-of-Cure visit (Day 4 to 8)|Safety Population||Proportion of blood||Standard Deviation|Mean
641773|NCT02294682|Secondary|Change From Baseline in Hemoglobin, Protein and Albumin at Test-of-Cure Visit (Day 4 to 8)|Blood samples were collected at Baseline Day 1 (pre-dose) and at TOC visit (Day 4 to 8) to evaluate hemoglobin, total protein and albumin. Baseline was defined as the study assessment on Day 1 (pre-dose). Change from Baseline was calculated as value obtained at TOC visit minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline visit and Test-of-Cure visit (Day 4 to 8)|Safety Population||Gram (G)/Liter (L)||Standard Deviation|Mean
641774|NCT02294682|Secondary|Number of Participants With Abnormal Physical Examination Finding|Physical examination of respiratory, cardiovascular, abdomen, gastrointestinal, urogenital systems, pharyngeal and rectal examinations with collections of microbiology specimen was performed at the Baseline and TOC (Day 4 to 8) visit. Baseline was defined as the study assessment on Day 1 (pre-dose). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline visit and Test-of-Cure visit (Day 4 to 8)|Safety Population||Participants|||Number
641775|NCT02294682|Secondary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings|A single 12-lead ECGs were obtained at the Baseline, 2 hour post-dose, and at the TOC (Day 4 to 8) visit using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and corrected QT (QTc) intervals. ECG was obtained prior to any vital sign measurements or blood draws scheduled on the same assessment day. For participants enrolled under protocol amendment 1, ECG was measured at Baseline visit Day 1 (pre-dose) only. ECG assessments were presented as abnormal-clinically significant (CS) and abnormal-not clinically significant (NCS) at the indicated time points. Only those participants available at the specified time points were analyzed (represented by n=X , X in the category titles).|Baseline visit and up to Day 8|Safety Population||Participants|||Number
641971|NCT02287610|Secondary|Assessment of Unsolicited Serious Adverse Events|Please refer to the safety section for further details.|Baseline to Last Follow up visit (up to 18.7 weeks)|||Participants|||Count of Participants
641776|NCT02294682|Secondary|Change From Baseline in Respiratory Rate at the Indicated Time Points|Respiratory rate was measured in semi-supine position after 5 minutes rest. It was recorded at Baseline visit, 2 hour post-dose visit for participants enrolled under orignal protocol, 0.5 hour post-dose for participants enrolled under protocol amendement 1 and up to TOC visit (Day 4 to 8). Vital sign measurements was obtained prior to any scheduled blood collection visit on the same assessment day. Baseline was defined as the study assessment on Day 1 (pre-dose). Change from Baseline was calculated as TOC Visit value minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline visit (Day 1) and Day 4 to Day 8|Safety Population||Breaths per minute||Standard Deviation|Mean
641777|NCT02294682|Secondary|Change From Baseline in Temperature at the Indicated Time Points|Temperature was measured in semi-supine position after 5 minutes rest. It was recorded at Baseline visit, 2 hour post-dose visit for participants enrolled under orignal protocol, 0.5 hour post-dose for participants enrolled under protocol amendement 1 and up to TOC visit (Day 4 to 8). Vital sign measurements were obtained prior to any scheduled blood collection visit on the same assessment day. Baseline was defined as the study assessment on Day 1 (pre-dose). Change from Baseline was calculated as TOC visit value minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline visit (Day 1) and Day 4 to Day 8|Safety Population||Celsius||Standard Deviation|Mean
641778|NCT02294682|Secondary|Change From Baseline in Pulse Rate at the Indicated Time Points|Pulse rate was measured in semi-supine position after 5 minutes rest. It was recorded at Baseline visit, 2 hour post-dose visit for participants enrolled under orignal protocol, 0.5 hour post-dose for participants enrolled under protocol amendement 1 and up to TOC visit (Day 4 to 8). Vital sign measurements were obtained prior to any scheduled blood collection visit on the same assessment day. Baseline was defined as the study assessment on Day 1 (pre-dose). Change from Baseline was calculated as TOC visit value minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline visit (Day 1) and Day 4 to Day 8|Safety Population||Beats per minute||Standard Deviation|Mean
641779|NCT02294682|Secondary|Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at the Indicated Time Points|BP was measured in semi-supine position after 5 minutes rest. It was recorded at Baseline visit, 2 hour post-dose visit for participants enrolled under orignal protocol, 0.5 hour post-dose for participants enrolled under protocol amendement 1 and up to TOC visit (Day 4 to 8).Vital sign measurements were obtained prior to any scheduled blood collection visit on the same assessment day. Baseline was defined as the study assessment on Day 1 (pre-dose). Change from Baseline was calculated as TOC visit value minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline visit (Day 1) and Day 4 to Day 8|Safety Population||Millimeter of mercury (mmHg)||Standard Deviation|Mean
641780|NCT02294682|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is any untoward medical occurrence in a clinical investigation participants, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinaemia (defined as alanine aminotransferase [ALT] >=3 times upper limit of normal [ULN] and bilirubin >=2 times ULN [>35 percent direct] [or ALT >=3 times ULN and international normalization ratio INR>1.5, if INR is measured].|From start of the study treatment until Test-of-Cure visit (Day 4 to 8)|Safety Population: comprised of all randomized participants who received any dose of study medication.||Participants|||Number
641781|NCT02294682|Primary|Number of Participants With Culture-confirmed Bacterial Eradication of Urogenital Neisseria Gonorrhoeae at the Test-of-Cure Visit|Pre-treatment urogenital, pharyngeal, and rectal swab specimens were obtained for bacteriological culture for neisseria (N.) gonorrhoeae at the Baseline visit. Test- of-Cure was defined by infection site (that is urogenital and, as appropriate, rectal and/or pharyngeal) as culture confirmed bacterial eradication of N. gonorrhoeae observed 3 to 7 days post-treatment. Pre-treatment urogenital specimens were obtained for nucleic acid amplification test (NAAT) assay to detect the presence of N. gonorrhoeae and chlamydia trachomatis at the Baseline visit. Only participants who had a pre-therapy N. gonorrhoeae isolate recovered from their urogenital specimen were evaluated. Microbiologically evaluable (ME) Population comprised of all randomized participants who had N. gonorrhoeae isolated from Baseline cultures of urogenital swab specimens, received any dose of gepotidacin, and returned for their TOC visit.|Baseline (Day 1, pre-dose) and Test-of-Cure visit (Day 4 to 8)|ME Population||Participants|||Number
641782|NCT02294604|Secondary|Duration of Hand Washing|The secondary outcome is the duration of hand washing|Immediately|||Minute||Standard Error|Mean
641783|NCT02294604|Secondary|Microorganisms on Hands After Surgery|The secondary outcomes is the colonies grown on bacterial culture plate|2 days after sampling|||colony forming unit||Standard Error|Mean
641784|NCT02294604|Secondary|Microorganisms on Hands After Scrubbing|The secondary outcomes is the colonies grown on bacterial culture plates and expressed as colony-forming units (CFU) on plates|2 days after sampling|||colony forming unit||Standard Error|Mean
641785|NCT02294604|Primary|Microorganisms on Hands Before Scrubbing|The primary outcome is the colonies grown on bacterial culture plates and expressed as colony-forming units (CFU) on plates|2 days after sampling|||colony forming unit||Standard Error|Mean
641810|NCT02292849|Primary|Number of Peer to Peer Clients Who Attend > 80% of Behavioral Activation Sessions|Number of Peer to Peer clients who attend > 80% of Behavioral Activation sessions|12 weeks|Clients assigned to receive Peer BA||Participants|||Count of Participants
641802|NCT02294019|Secondary|Percentage of Participants Taking Greater Than (>) 400 mg (>1 Caplet) at a Time on no More Than 2 Dosing Occasions During the Study|Percentage of participants whose behavior was either correct or acceptable were considered to be compliant. The behavior was considered correct if the total number of dosing occasions (distinct usage date/time values from their diary) in which a participant received 2 or more caplets was 0, 1 or 2. The behavior was considered acceptable if a participant exceeded the labelled daily dosing directions of taking no more than 1 caplet per dose, under the advice of a healthcare professional, based on the end of study follow up interview.|Day1 up to 30 days|Actual use population included all participants who purchased the study medication and recorded the use of study medication in the diary on or after the first purchase date, and returned the diary.||percentage of participants||95% Confidence Interval|Number
641803|NCT02294019|Primary|Percentage of Participants Taking Greater Than (>) 1200 Milligram (mg) (>3 Caplets) on no More Than 2 Use Days During the Study|Percentage of participants whose behavior was either correct or acceptable were considered to be compliant. The behavior was considered correct if participants took more than 1200 mg (>3 caplets) on either 0, 1 or 2 use days (where a use day was defined as a calendar day starting at 12:01 AM in which a participant received at least one dose of study medication), based on their diary. The behavior was considered acceptable if a participant exceeded the labelled daily dosing directions of taking more than 3 caplets per day, under the advice of a healthcare professional, based on information from the end of study follow-up interview.|Day 1 up to 30 days|Actual use population included all participants who purchased the study medication and recorded the use of study medication in the diary on or after the first purchase date, and returned the diary.||percentage of participants||95% Confidence Interval|Number
641804|NCT02293538|Secondary|Mean Pre-lens Tear Lipid Layer Thickness After 2 Hours of Lens Wear on Day 14|The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The anterior-most layer of the pre-lens tear film consists of lipids. Lipid layer thickness (LLT) is measured with the LipiView® Interferometer. LLT is measured in interferometric color units (ICUs), where 1 ICU reflects about 1 nanometer (nm) lipid layer thickness. Higher values of LLT indicate a better lubrication of the ocular surface. A thicker tear lipid layer helps reduce evaporation and is indicative of a more stable tear film. The right eye only was used for this measure.|Day 14, after 2 hours of lens wear|Intention to treat participants with non-missing observations||ICU||Standard Deviation|Mean
641805|NCT02293538|Secondary|Mean Change From Baseline in Comfortable Lens Wear Time (Time Uncomfortable - Time Insertion) to Day 14|At Baseline and on Day 14, comfort was collected through participant questionnaires regarding average and comfortable wear time. Participants filled in what time of day (over the past three days) they usually inserted their lenses, removed them, and at what time they usually became uncomfortable, or if they remained comfortable all day. Comfortable wear time was calculated as Time Uncomfortable minus Time Insertion. A positive change from Baseline indicates improvement. The participant rated both eyes together by providing one single rating.|Baseline (Day 0), Day 14|Intention to treat participants with non-missing observations||hours||Standard Deviation|Mean
641806|NCT02293538|Secondary|Percentage of Participants That Experienced At Least 1 Unit Increase From Baseline Score to Day 14 for Overall Comfort With Lenses|Overall comfort was rated by the participant on a 10-point scale, where 1=Poor and 10=Excellent, at Day 0 for their habitual lenses and at Day 14 for the lenses worn for the study during use of the assigned drop regimen. A 1-unit increase indicates improvement. The participant rated both eyes together by providing one single rating.|Baseline (Day 0), Day 14|Intention to treat participants with non-missing observations||percentage of participants|||Number
641807|NCT02293538|Secondary|Mean Comfortable Lens Wear Time (Time Uncomfortable – Time Insertion) at Baseline and Day 14|At Baseline and on Day 14, comfort was collected through participant questionnaires regarding average and comfortable wear time. Participants filled in what time of day (over the past three days) they usually inserted their lenses, removed them, and at what time they usually became uncomfortable, or if they remained comfortable all day. Comfortable wear time was calculated as Time Uncomfortable minus Time Insertion. The participant rated both eyes together by providing one single rating. This outcome measure was prespecified for only FID 114657.|Baseline (Day 0), Day 14|Intention to treat participants with non-missing observations||hours||Standard Deviation|Mean
641808|NCT02293538|Primary|Mean Pre-lens Tear Lipid Layer Thickness After 2 Hours of Lens Wear on Day 1|The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The anterior-most layer of the pre-lens tear film consists of lipids. Lipid layer thickness (LLT) is measured with the LipiView® Interferometer. LLT is measured in interferometric color units (ICUs), where 1 ICU reflects about 1 nanometer (nm) lipid layer thickness. Higher values of LLT indicate a better lubrication of the ocular surface. A thicker tear lipid layer helps reduce evaporation and is indicative of a more stable tear film. The right eye only was used for this measure.|Day 1, after 2 hours of lens wear|Intention to treat participants with non-missing observations||ICU||Standard Deviation|Mean
641809|NCT02292849|Secondary|Changes in Hamilton Depression Rating Scale Scores|Hamilton Depression Rating Scale mean change scores from baseline to 12 weeks. This scale measures severity of depressive symptoms (range=0-76), with higher scores indicating more sever depressive symptomatology.|Baseline and 12 weeks|Randomized clients||units on a scale||Standard Deviation|Mean
641811|NCT02292849|Primary|Proportion of Peer to Peer Coaches Who Undergo Behavioral Activation Training and Achieve Certification|Proportion of Peer to Peer coaches who undergo Behavioral Activation training and achieve certification|4 weeks prior to Baseline|This outcome analyzed Peer to Peer coaches who were eligible to provide the Behavioral Activation intervention||Participants|||Count of Participants
641812|NCT02292433|Secondary|Change From Baseline in Pre-Meal C-Peptide at Day 7|Time-matched change from baseline in pre-meal serum C-peptide on Day 7 of each period was analyzed. Pre-meal C-peptide levels therefore, pre-breakfast, pre-lunch, and pre-dinner were analyzed.|Pre-morning meal (pre-breakfast), 5 hours (pre-lunch), 11 hours (pre-dinner) after morning meal on Day 0 (Baseline); pre-morning dose (pre-breakfast), 5 hours (pre-lunch), 11 hours (pre-dinner) post-morning dose on Day 7|PD analysis population included all randomized participants who received at least 1 dose of study medication and had both a baseline and a post-baseline assessment for at least 1 PD parameter in at least 1 period.||ng/mL||Standard Deviation|Mean
641813|NCT02292433|Secondary|Change From Baseline in Pre-Meal Insulin at Day 7|Time-matched change from baseline in pre-meal serum insulin on Day 7 of each period was analyzed. Pre-meal insulin levels therefore, pre-breakfast, pre-lunch, and pre-dinner were analyzed.|Pre-morning meal (pre-breakfast), 5 hours (pre-lunch), 11 hours (pre-dinner) after morning meal on Day 0 (Baseline); pre-morning dose (pre-breakfast), 5 hours (pre-lunch), 11 hours (pre-dinner) post-morning dose on Day 7|PD analysis population included all randomized participants who received at least 1 dose of study medication and had both a baseline and a post-baseline assessment for at least 1 PD parameter in at least 1 period.||micro international unit per milliliter||Standard Deviation|Mean
641814|NCT02292433|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Last Day of Treatment|FPG was defined as plasma glucose measurements taken pre-breakfast, in the fasted state, and prior to dosing with study drug. Baseline was defined as the average of Hour 0 measurements taken on Day 0 and Day 1 in each intervention period. The measurement on the last day of treatment was defined as the average of Hour 0 measurements taken on Day 7 and Day 8 in each period.|Pre-morning meal on Day 0, pre-morning dose on Day 1, pre-morning dose on Day 7, pre-morning meal on Day 8|PD analysis population included all randomized participants who received at least 1 dose of study medication and had both a baseline and a post-baseline assessment for at least 1 PD parameter in at least 1 period.||mg/dL||Standard Deviation|Mean
641815|NCT02292433|Secondary|Change From Baseline in Weighted Mean Daily Glucose (WMDG) at Day 7|WMDG was defined as time-weighted mean daily glucose. WMDG was calculated by as the time-weighted mean of glucose levels at actual time points for glucose sampling, for Day 0 (Baseline) and Day 7.|Pre-morning meal, 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 16 and 20 hours post- morning meal on Day 0; pre-morning dose, 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 16, 20 hours post-morning dose on Day 7|The pharmacodynamic (PD) analysis population included all randomized participants who received at least 1 dose of study medication and had both a baseline and a post-baseline assessment for at least 1 PD parameter in at least 1 period.||mg/dL||Standard Deviation|Mean
641816|NCT02292433|Secondary|Metabolite to Parent Ratio for AUC24 (MRAUC24) on Day 7|MRAUC24 is the ratio of AUC24 of PF-06455349 (metabolite) to AUC24 of PF-04937319 (parent drug) * ratio of molecular weight of PF-04937319 to molecular weight of PF-06455349, where AUC24 is the area under the plasma concentration-time profile from time 0 to 24 hours. PF-06455349 is a metabolite of PF-04937319.|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.||ratio||Geometric Coefficient of Variation|Geometric Mean
641817|NCT02292433|Secondary|Accumulation Ratio (Rac) on Day 7 for PF-06455349|Rac is based on AUC24. It is the ratio of AUC24 of Day 7 and AUC24 of Day 1, where AUC24 is the area under the plasma concentration-time profile from time 0 to 24 hours. PF-06455349 is a metabolite of PF-04937319.|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.||ratio||Geometric Coefficient of Variation|Geometric Mean
641818|NCT02292433|Secondary|Terminal Half-Life (t1/2) on Day 7 for PF-06455349|Terminal half-life is the time measured for the plasma concentration to decrease by one half. Terminal half-life is calculated by dividing the natural logarithm to the base e (Log e) * 2/k el, where ‘k el’ is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression. PF-06455349 is a metabolite of PF-04937319.|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24, 36, 48 hours post morning dose on Day 7|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.||hour||Standard Deviation|Mean
641819|NCT02292433|Secondary|Average Plasma Concentration (Cav) on Day 7 for PF­-06455349|Cav is the average plasma concentration during the 0 to 24 hour time period. PF-06455349 is a metabolite of PF-04937319.|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
641820|NCT02292433|Secondary|Pre-dose Plasma Concentration (Ctrough) on Day 7 for PF­-06455349|Ctrough is the concentration prior to study drug administration. PF-06455349 is a metabolite of PF-04937319.|0 hour (pre-dose) on Day 7|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
641821|NCT02292433|Secondary|Area Under the Concentration-Time Curve (AUC24) From Time Zero to 24 Hour on Day 7 for PF-­06455349|AUC24 is the area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose (0 to 24). PF-06455349 is a metabolite of PF-04937319.|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
641822|NCT02292433|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 7 for PF-06455349|PF-06455349 is a metabolite of PF-04937319.|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24, 36, 48 hours post morning dose on Day 7|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.||hour||Full Range|Median
641823|NCT02292433|Secondary|Maximum Observed Plasma Concentration (Cmax) on Day 7 for PF­-06455349|PF-06455349 is a metabolite of PF-04937319.|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24, 36, 48 hours post morning dose on Day 7|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
641824|NCT02292433|Secondary|Metabolite to Parent Ratio for AUC24 (MRAUC24) on Day 1|MRAUC24 is the ratio of AUC24 of PF-06455349 (metabolite) to AUC24 of PF-04937319 (parent drug) * ratio of molecular weight of PF-04937319 to molecular weight of PF-06455349, where AUC24 is the area under the plasma concentration-time profile from time 0 to 24 hours.|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 1|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.||ratio||Geometric Coefficient of Variation|Geometric Mean
641825|NCT02292433|Secondary|Area Under the Concentration-Time Curve (AUC24) From Time Zero to 24 Hour on Day 1 for PF­-06455349|AUC24 is the area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose (0 to 24). PF-06455349 is a metabolite of PF-04937319.|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 1|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
641826|NCT02292433|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 1 for PF-06455349|PF-06455349 is a metabolite of PF-04937319.|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 1|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.||hour||Full Range|Median
641827|NCT02292433|Secondary|Maximum Observed Plasma Concentration (Cmax) on Day 1 for PF-06455349|PF-06455349 is a metabolite of PF-04937319.|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 1|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
641828|NCT02292433|Primary|Accumulation Ratio (Rac) on Day 7 for PF-04937319|Rac is based on AUC24. It is the ratio of AUC24 of Day 7 and AUC24 of Day 1, where AUC24 is the area under the plasma concentration-time profile from time 0 to 24 hours.|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.||ratio||Geometric Coefficient of Variation|Geometric Mean
641829|NCT02292433|Primary|Apparent Volume of Distribution on Day 7 for PF-04937319|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose is influenced by the oral bioavailability. It is calculated as the total oral daily dose divided by AUC24* k el, where AUC24 is the area under the plasma concentration-time profile from time 0 to 24 hours and terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.||liter||Geometric Coefficient of Variation|Geometric Mean
641830|NCT02292433|Primary|Terminal Half-Life (t1/2) on Day 7 for PF-04937319|Terminal half-life is the time measured for the plasma concentration to decrease by one half. Terminal half-life is calculated by dividing the natural logarithm to the base e (Log e) multiplied by (*) 2/k el, where ‘k el’ is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24, 36, 48 hours post morning dose on Day 7|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.||hour||Standard Deviation|Mean
641831|NCT02292433|Primary|Apparent Oral Clearance on Day 7 for PF-04937319|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the oral bioavailability. It is calculated as the total oral daily dose divided by AUC24, where AUC24 is the area under the plasma concentration-time profile from time 0 to 24 hours.|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.||milliliter per minute (mL/min)||Geometric Coefficient of Variation|Geometric Mean
641832|NCT02292433|Primary|Average Plasma Concentration (Cav) on Day 7 for PF-04937319|Cav is the average plasma concentration during the 0 to 24 hour time period.|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
641833|NCT02292433|Primary|Pre-dose Plasma Concentration (Ctrough) on Day 7 for PF-04937319|Ctrough is the concentration prior to study drug administration.|0 hour (pre-dose) on Day 7|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
641834|NCT02292433|Primary|Area Under the Concentration-Time Curve (AUC24) From Time Zero to 24 Hour on Day 7 for PF-04937319|AUC24 is the area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose (0 to 24).|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
641835|NCT02292433|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 7 for PF-04937319||0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24, 36, 48 hours post morning dose on Day 7|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.||hour||Full Range|Median
641836|NCT02292433|Primary|Maximum Observed Plasma Concentration (Cmax) on Day 7 for PF-04937319||0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24, 36, 48 hours post morning dose on Day 7|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
641837|NCT02292433|Primary|Area Under the Concentration-Time Curve (AUC24) From Time Zero to 24 Hour on Day 1 for PF-04937319|AUC24 is the area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose (0 to 24).|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post-dose on Day 1|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.||nanogram*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
641838|NCT02292433|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 1 for PF-04937319||0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 1|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.||hour||Full Range|Median
641839|NCT02292433|Primary|Maximum Observed Plasma Concentration (Cmax) on Day 1 for PF-04937319||0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 1|Pharmacokinetic (PK) parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
641840|NCT02292433|Primary|Number of Participants With Protocol Defined Hypoglycaemic Adverse Events (HAEs)|A hypoglycemic event (HAE) was identified by characteristic symptoms or blood glucose levels. HAE was defined as 1 of the given definitions: 1) Characteristic symptoms of HAE with no home glucose monitoring performed where clinical picture included prompt resolution with food intake, subcutaneous glucagon, or intravenous glucose; 2) Characteristic symptoms of HAE with home glucose monitoring measurement of less than or equal to (=<) 70 milligram per deciliter (mg/dL) using sponsor-provided, plasma-referenced, home glucometers (or central laboratory); 3) any glucose value =<49 mg/dL using sponsor-provided, plasma-referenced, home glucometers (or central laboratory) with or without accompanying symptoms.|Baseline up to 14 days after the last dose of study drug (minimum 8 weeks to maximum of 17 weeks)|Safety analysis set included all participants who received at least 1 dose of study medication (including placebo) in at least 1 period.||participants|||Number
641841|NCT02292433|Primary|Number of Participants With Treatment Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 14 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.|Baseline up to 14 days after the last dose of study drug (minimum 8 weeks to maximum of 17 weeks)|Safety analysis set included all participants who received at least 1 dose of study medication (including placebo) in at least 1 period.||participants|||Number
641842|NCT02292212|Secondary|Device Malfunctions||Week 1 to 2 (Pre-ViE phase), 3 to 14 (ViE phase), and 15 to 16 (Post-ViE phase)|The safety analysis population (SAA) that is comprised of all patients that received at least one session with the ViE-21||malfunctions|||Number
641843|NCT02292212|Primary|Activated Complement Factor III (C3a )|Blood samples were obtained during the first week of dialysis with control dialyzer and then during weeks 7 and 13 with ViE-21. C3a was measured pre dialysis, at 15 minutes and post dialysis. The values were corrected with HCT and then leveled by defining the pre-dialysis value as 100%.|Week 1 (Pre-ViE phase), 7, 13 (ViE phase)|The Intent To Treat (ITT) was based on 14 patients that received at least 30 treatments with ViE-21.||percentage of C3a level||Standard Deviation|Mean
641844|NCT02292212|Primary|Platelet|Blood samples were obtained during the first week of dialysis with control dialyzer and then during weeks 7 and 13 with ViE-21. Platelet count was measured pre dialysis, at 15 minutes and post dialysis. The values were corrected with HCT and then leveled by defining the pre-dialysis value as 100%.|Week 1 (Pre-ViE phase), 7, 13 (ViE phase)|The Intent To Treat (ITT) was based on 14 patients that received at least 30 treatments with ViE-21.||percentage of platelet level||Standard Deviation|Mean
641845|NCT02292212|Primary|White Blood Cell (WBC)|Blood samples were obtained during the first week of dialysis with control dialyzer and then during weeks 7 and 13 with ViE-21. WBC count was measured pre dialysis, at 15 minutes and post dialysis. The values were corrected with HCT and then leveled by defining the pre-dialysis value as 100%.|Week 1 (Pre-ViE phase), 7, 13 (ViE phase)|The Intent To Treat (ITT) was based on 14 patients that received at least 30 treatments with ViE-21.||percentage of WBC level||Standard Deviation|Mean
641878|NCT02290509|Secondary|Number of Participants With Systemic and Injection Site Reactogenicity||Days 0-7|The Reactogenicity Population includes subjects who recorded any systemic reaction data and injection site reaction data following administration of study vaccine. This was two subjects less than the Safety Population.||participants|||Number
641972|NCT02287610|Secondary|Assessment of Unsolicited Adverse Events|Please refer to the safety section for further details.|Baseline to Last Follow up visit (up to 18.7 weeks)|||Participants|||Count of Participants
641846|NCT02292212|Primary|Ultrafiltration Coefficient (KUF)|The KUF is important for regulating the rate and amount of fluid flow across the dialyzer membrane. It is calculated by dividing ultrafiltration rate with the transmembrane pressure (TMP). More specifically, transmembrane pressures were recorded at 10, 20, 30, 40 and 50 minutes after the initiation of the dialysis session with adjustment of the ultrafiltration rate at 0, 600, 1000, 1400 and 1800 mL/hr respectively. These determinations were made during the 2nd or 3rd treatment session during the 1st or 2nd week for control dialyzer (Pre-ViE phase), and for ViE-21 during week 3-8 and week 9-14 (ViE phase).|Week 1 or 2 (Pre-ViE phase), 3-8 and 9-14 (ViE phase)|The Intent To Treat (ITT) was based on 14 patients that received at least 30 treatments with ViE-21.||mL/(hr*mmHg)||Standard Deviation|Mean
641847|NCT02292212|Primary|Removal Rate of Beta-2-microglobulin (B2-MG)|"In order to calculate removal rate for B2-MG by a dialysis session, blood samples were collected at pre and post dialysis. The removal rate was obtained by calculation using the following equation.
Removal rate (%) = {1-[HCTpre*(1-HCTpost/100) * Cpost] / [HCTpost * (1-HCTpre/100) * Cpre]} * 100.
The removal rates were obtained at one session of the first week with control dialyzer (Pre-ViE phase) and then at each one session of weeks 7 and 13 with ViE-21 (ViE phase), respectively."|Week 1 (Pre-ViE phase), 7, 13 (ViE phase)|The Intent To Treat (ITT) was based on 14 patients that received at least 30 treatments with ViE-21.||percentage of B2MG removal||Standard Deviation|Mean
641848|NCT02292212|Primary|Removal Rate of Albumin|"In order to calculate removal rate for albumin by a dialysis session, blood samples were collected at pre and post dialysis. The removal rate was obtained by calculation using the following equation with hematocrit (HCT) at pre (HCTpre) and post (HCTpost).
Removal rate (%) = {1-[HCTpre*(1-HCTpost/100) * Cpost] / [HCTpost * (1-HCTpre/100) * Cpre]} * 100.
The removal rates were obtained at one session of the first week with control dialyzer (Pre-ViE phase) and then at each one session of weeks 7 and 13 with ViE-21 (ViE phase), respectively. The negative removal rate means the increase of serum concentration of albumin from pre to post dialysis session."|Week 1 (Pre-ViE phase), 7, 13 (ViE phase)|The Intent To Treat (ITT) was based on 14 patients that received at least 30 treatments with ViE-21.||percentage of albumin removal||Standard Deviation|Mean
641849|NCT02292212|Primary|Removal Rate of Creatinine|"In order to calculate removal rate for creatinine by a dialysis session, blood samples were collected at pre and post dialysis. The removal rate was obtained by calculation using the following equation.
Removal rate (%) = [(Cpre - Cpost) / (Cpre)] * 100. The removal rates were obtained at one session of the first week with control dialyzer (Pre-ViE phase) and then at each one session of weeks 7 and 13 with ViE-21 (ViE phase), respectively."|Week 1 (Pre-ViE phase), 7, 13 (ViE phase)|The Intent To Treat (ITT) was based on 14 patients that received at least 30 treatments with ViE-21.||percentage of creatinine removal||Standard Deviation|Mean
641850|NCT02292212|Primary|Removal Rate of Urea|"In order to calculate removal rate for urea by a dialysis session, blood samples were collected at pre and post dialysis. The removal rate was obtained by calculation using the following equation with Pre-dialysis concentration (Cpre) and Post-dialysis concentration (Cpost) of urea.
Removal rate (%) = [(Cpre - Cpost) / (Cpre)] * 100. The removal rates were obtained at one session of the first week with control dialyzer (Pre-ViE phase) and then at each one session of weeks 7 and 13 with ViE-21 (ViE phase), respectively."|Week 1 (Pre-ViE phase), 7, 13 (ViE phase)|The Intent To Treat (ITT) was based on 14 patients that received at least 30 treatments with ViE-21.||percentage of urea removal||Standard Deviation|Mean
641851|NCT02291718|Secondary|Variation in Contrast for the Entire Vascular System (coV)|The change in contrast was measured at the proximal segment of the aorta and at the Iliac arteries for each subject.|30 minutes|||unitless||Standard Deviation|Mean
641852|NCT02291718|Secondary|Hounsfield Unit Attenuation Values|Grayscale values on CT scans are given as Hounsfield units. These Hounsfield units reflect the attenuation of x-ray beams traversing the aortic lumen. We will use Hounsfield units to assess whether the tool contrast agents achieve similar attenuation characteristics essential for diagnosing aortic abnormalities. We will use circular regions of interest in the thoracic aorta to extract the Hounsfield unit measurements.|30 minutes|||Hounsfield units||Standard Deviation|Mean
641853|NCT02291718|Secondary|Signal to Noise Ratio|Calculated as the ratio of mean attenuation values divided by the standard deviation of attenuation values gathered using a circular region of interest in the thoracic aorta.|30 minutes|Hiatus region of each subject group||Signal-to-Noise Ratio||Standard Deviation|Mean
641854|NCT02291718|Primary|Radiation Dose||30 minutes|||mSv||Standard Deviation|Mean
641855|NCT02291679|Other Pre-specified|Percentage of 12-Week CSBM Overall Sustained Responders|"A 12-week CSBM Overall Sustained Responder is a participant who was a CSBM Weekly Responder for at least 9 of the 12 weeks of the Treatment Period, including ≥ 3 of the last 4 weeks. A CSBM Weekly Responder is a participant who had a CSBM weekly frequency rate that was 3 or greater and increased by 1 or more from baseline, and completed ≥ 4 IVRS calls for the specified week.
A CSBM is defined as an SBM that is associated with a sense of complete evacuation. An SBM is defined as a BM that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM."|Week 12|Intent-to-Treat Population: all randomized participants who received at least one dose of study drug. Only data for the 72 μg dose versus placebo arms were prospectively defined and evaluated as a secondary endpoint; data for the 145 μg dose arm were defined and evaluated as an additional endpoint per protocol.||percentage of participants|||Number
641856|NCT02291679|Secondary|Change From Baseline in 12-Week Abdominal Discomfort|Abdominal discomfort was measured daily using an 11-point NRS (0 = none; 10 = very severe). The participant's abdominal discomfort score for the Treatment Period is the average of the non-missing daily participant assessments of abdominal discomfort scores reported during the 12-week Treatment Period.|Baseline, Week 1 to Week 12|Intent-to-Treat Population: all randomized participants who received at least one dose of study drug. Only data for the 72 μg dose versus placebo arms were prospectively defined and evaluated as a secondary endpoint; data for the 145 μg dose arm were defined and evaluated as an additional endpoint per protocol.||units on a scale||Standard Error|Least Squares Mean
641897|NCT02289963|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Non-HDL-C ITT population.||percent change||Standard Deviation|Least Squares Mean
642456|NCT02274792|Secondary|Percentage of Participants With Positive Anti-etanercept Binding Antibody Response at Week 24||Week 24|Participants with available antibody response data at week 24||percentage of participants||95% Confidence Interval|Number
641857|NCT02291679|Secondary|Change From Baseline in 12-Week Abdominal Bloating|Abdominal bloating was measured daily using an 11-point NRS (0 = none; 10 = very severe). The participant's abdominal bloating score for the Treatment Period is the average of the non-missing daily participant assessments of abdominal bloating scores reported during the 12-week Treatment Period.|Baseline, Week 1 to Week 12|Intent-to-Treat Population: all randomized participants who received at least one dose of study drug. Only data for the 72 μg dose versus placebo arms were prospectively defined and evaluated as a secondary endpoint; data for the 145 μg dose arm were defined and evaluated as an additional endpoint per protocol.||units on a scale||Standard Error|Least Squares Mean
641858|NCT02291679|Secondary|Percentage of Month 3 CSBM Responders|"A Month 3 CSBM Responder is a participant who is a CSBM weekly responder for at least 3 of the 4 weeks of Month 3 of the Treatment Period. A CSBM weekly responder is a participant who had a CSBM weekly frequency rate that was 3 or greater and increased by 1 or more from baseline based on a minimum of 4 complete IVRS calls for that week.
A CSBM is defined as an SBM that is associated with a sense of complete evacuation. An SBM is defined as a BM that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM."|Month 3|Intent-to-Treat Population: all randomized participants who received at least one dose of study drug. Only data for the 72 μg dose versus placebo arms were prospectively defined and evaluated as a secondary endpoint; data for the 145 μg dose arm were defined and evaluated as an additional endpoint per protocol.||percentage of participants|||Number
641859|NCT02291679|Secondary|Percentage of Month 2 CSBM Responders|"A Month 2 CSBM Responder is a participant who is a CSBM weekly responder for at least 3 of the 4 weeks of Month 2 of the Treatment Period. A CSBM weekly responder is a participant who had a CSBM weekly frequency rate that was 3 or greater and increased by 1 or more from baseline based on a minimum of 4 complete IVRS calls for that week.
A CSBM is defined as an SBM that is associated with a sense of complete evacuation. An SBM is defined as a BM that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM."|Month 2|Intent-to-Treat Population: all randomized participants who received at least one dose of study drug. Only data for the 72 μg dose versus placebo arms were prospectively defined and evaluated as a secondary endpoint; data for the 145 μg dose arm were defined and evaluated as an additional endpoint per protocol.||percentage of participants|||Number
641860|NCT02291679|Secondary|Percentage of Month 1 CSBM Responders|"A Month 1 CSBM Responder is a participant who is a CSBM weekly responder for at least 3 of the 4 weeks of Month 1 of the Treatment Period. A CSBM weekly responder is a participant who had a CSBM weekly frequency rate that was 3 or greater and increased by 1 or more from baseline based on a minimum of 4 complete IVRS calls for that week.
A CSBM is defined as an SBM that is associated with a sense of complete evacuation. An SBM is defined as a BM that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM."|Month 1|Intent-to-Treat Population: all randomized participants who received at least one dose of study drug. Only data for the 72 μg dose versus placebo arms were prospectively defined and evaluated as a secondary endpoint; data for the 145 μg dose arm were defined and evaluated as an additional endpoint per protocol.||percentage of participants|||Number
641861|NCT02291679|Secondary|Percentage of 12-Week CSBM Overall Responders (>1 SBM/Week Subpopulation)|"A 12-week CSBM Overall Responder is a participant who was a CSBM Weekly Responder for at least 9 of the 12 weeks of the Treatment Period. A CSBM Weekly Responder is a participant who had a CSBM weekly frequency rate that was 3 or greater and increased by 1 or more from baseline, and completed ≥4 IVRS calls for the specified week.
A CSBM is defined as an SBM that is associated with a sense of complete evacuation. An SBM is defined as a BM that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM."|Week 12|Participants in the Intent-to-Treat Population who reported >1 SBM/week during the Pretreatment Period (14 days prior to randomization). Only data for the 72 μg dose versus placebo arms were prospectively defined and evaluated as a secondary endpoint; data for the 145 μg dose arm were defined and evaluated as an additional endpoint per protocol.||percentage of participants|||Number
641862|NCT02291679|Secondary|Change From Baseline in 12-Week Straining Score|Straining was measured daily using a 5-point ordinal scale (1 = not at all; 2 = a little bit; 3 = a moderate amount; 4 = a great deal; 5 = an extreme amount). The participant's straining score for the Treatment Period is the average of the non-missing straining scores from the SBMs reported by the participant during the 12-week Treatment Period.|Baseline, Week 1 to Week 12|Intent-to-Treat Population: all randomized participants who received ≥ 1 dose of study drug and reported an SBM during the Baseline period. Only data for the 72 μg dose versus placebo arms were prospectively defined and evaluated as a secondary endpoint; data for the 145 μg dose arm were defined and evaluated as an additional endpoint per protocol.||units on a scale||Standard Error|Least Squares Mean
641863|NCT02291679|Secondary|Change From Baseline in 12-Week Stool Consistency Score|Stool consistency was measured daily using the 7-point ordinal Bristol Stool Form Scale (BSFS; 1 = separate hard lumps like nuts [difficult to pass]; 2 = sausage shaped but lumpy; 3 = like a sausage but with cracks on surface; 4 = like a sausage or snake, smooth and soft; 5 = soft blobs with clear-cut edges [passed easily]; 6 = fluffy pieces with ragged edges, a mushy stool; 7 = watery, no solid pieces [entirely liquid]). The participant's BSFS score for the Treatment Period is the average of the non-missing BSFS scores from the SBMs reported by the participant during the 12-week Treatment Period.|Baseline, Week 1 to Week 12|Intent-to-Treat Population: all randomized participants who received ≥ 1 dose of study drug and reported an SBM during the Baseline period. Only data for the 72 μg dose versus placebo arms were prospectively defined and evaluated as a secondary endpoint; data for the 145 μg dose arm were defined and evaluated as an additional endpoint per protocol.||units on a scale||Standard Error|Least Squares Mean
641864|NCT02291679|Secondary|Change From Baseline in 12-Week SBM Frequency Rate|A participant's 12-week SBM Frequency Rate is the SBM rate (SBMs/week) calculated over the 12-weeks of the Treatment Period. An SBM is defined as a BM that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM.|Baseline, Week 1 to Week 12|Intent-to-Treat Population: all randomized participants who received at least one dose of study drug. Only data for the 72 μg dose versus placebo arms were prospectively defined and evaluated as a secondary endpoint; data for the 145 μg dose arm were defined and evaluated as an additional endpoint per protocol.||SBMs/week||Standard Error|Least Squares Mean
642523|NCT02273115|Secondary|Total Time to Delivery||On average, 24-36 hours|||hours||Inter-Quartile Range|Median
641865|NCT02291679|Secondary|Change From Baseline in 12-Week CSBM Frequency Rate|A participant's 12-week CSBM Frequency Rate is the CSBM rate (CSBMs/week) calculated over the 12 weeks of the Treatment Period. A CSBM is defined as an SBM that is associated with a sense of complete evacuation. An SBM is defined as a BM that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM.|Baseline, Week 1 to Week 12|Intent-to-Treat Population: all randomized participants who received at least one dose of study drug. Only data for the 72 μg dose versus placebo arms were prospectively defined and evaluated as a secondary endpoint; data for the 145 μg dose arm were defined and evaluated as an additional endpoint per protocol.||CSBMs/week||Standard Error|Least Squares Mean
641866|NCT02291679|Primary|Percentage of 12-Week CSBM Overall Responders|"A 12-week CSBM Overall Responder is a participant who was a CSBM Weekly Responder for at least 9 of the 12 weeks of the Treatment Period. A CSBM Weekly Responder is a participant who had a CSBM weekly frequency rate that was 3 or greater and increased by 1 or more from baseline, and completed ≥ 4 IVRS calls for the specified week.
A CSBM is defined as an SBM that is associated with a sense of complete evacuation. An SBM is defined as a bowel movement BM that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM."|Week 12|Intent-to-Treat Population: all randomized participants who received at least one dose of study drug. Only data for the 72 μg dose versus placebo arms were prospectively defined and evaluated as a primary endpoint; per protocol, data for the 145 μg dose arm were not collected for any pre-specified primary or secondary outcome measures.||percentage of participants|||Number
641867|NCT02291510|Primary|Cmax of Plasma Metformin|Cmax = Maximum concentration from the first dose of study medication administration (0 h) to the time of the last quantifiable concentration following dose administration. Doses were administered 1 min prior to 0 h (standardized dinner) for qPM and BID dosing and 1 min prior to 12 h (standardized breakfast) for qAM and BID dosing.|Time points to create Cmax were: t = -0.08, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 11.92, 12.5, 13, 13.5, 14, 14.5, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 hours relative to the start time of the standardized dinner.|Evaluable Population||ng/mL||Standard Error|Mean
641868|NCT02291510|Primary|AUC (0-t) of Plasma Metformin|AUC (0-t) = Area under the curve from the time of dosing (0 h) to the time of the last quantifiable concentration after the standardized dinner. Doses were administered 1 min prior to 0 h (standardized dinner) for once daily in the evening (qPM) and twice daily (BID) dosing and 1 min prior to 12 h (standardized breakfast) for once daily in the morning (qAM) and BID dosing.|Time points to create AUC (0-t) were: t = -0.08, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 11.92, 12.5, 13, 13.5, 14, 14.5, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 hours relative to the start time of the standardized dinner.|Evaluable Population||ng*h/mL||Standard Error|Mean
641869|NCT02291419|Other Pre-specified|The Number of Participants With Bleeding According to Bleeding Academic Research Consortium (BARC) Definitions||up to 6 months. The planned duration of treatment was one year but the study was terminated after 6 months.|||Participants|||Count of Participants
641870|NCT02291419|Secondary|Non-fatal Stroke|Time to first occurence of Non-fatal stroke. The number of participants with events was reported.|up to 6 months. The planned duration of treatment was one year but the study was terminated after 6 months.|||Participants|||Count of Participants
641871|NCT02291419|Secondary|All-cause Death|Time to first occurence of All-cause death. The number of participants with events was reported.|up to 6 months. The planned duration of treatment was one year but the study was terminated after 6 months.|||Participants|||Count of Participants
641872|NCT02291419|Secondary|Non-fatal Myocardial Infarction or Coronary Revascularization|Time to first occurence of Non-fatal myocardial infarction or coronary revascularization. The number of participants with events was reported.|up to 6 months. The planned duration of treatment was one year but the study was terminated after 6 months.|||Participants|||Count of Participants
641873|NCT02291419|Secondary|Cardiovascular Death|Time to first occurence of Cardiovascular death. The number of patients with events was reported.|Up to 6 months. The planned duration of treatment was one year but the study was terminated after 6 months.|||Participants|||Count of Participants
641874|NCT02291419|Primary|Major Adverse Cardiovascular Events|Time to first occurence of the composite of Cardiovascular Death, Non-fatal Myocardial Infarction, Coronary Revascularization or Non-fatal Stroke. The number of patients with events is reported.|up to 6 months. The planned duration of treatment was one year but the study was terminated after 6 months.|||Participants|||Count of Participants
641875|NCT02290821|Primary|Sum of Pain Intensity Differences Over 24 Hours After Initiating Treatment (SPID 24)|The primary efficacy outcome was the time-weighted SPID 24 (POW). Sum of pain intensity differences over 24 hours after initiating treatment (SPID 24) for the ITT population. SPID 24 derived from spontaneous Pain Intensity scores assessed over 24 hours on a 0 (No pain) – 10 (Pain as bad as you can imagine) Numerical Rating Scale. SPID 24 was computed using the trapezoidal rule, i.e. Σ [T(i) – T(i-1)] x [((PID)(i-1) + PID(i))/2] in an obvious notation, where T(i) is nominal time and PID(i), the pain intensity difference at Time i, is the baseline pain intensity (PI) score - PI score at Time i. Scores were assessed hourly for the first 4 hours and then every 2 hours whilst subjects were awake. Linear interpolation was used to compute an exact SPID as of 24 hours. SPID-24 was computed after all imputation of missing assessments and post-rescue assessments had been completed.|24 hours|||units on a scale||Standard Deviation|Mean
641876|NCT02290509|Primary|Geometric Mean Titers of Antibodies to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine|Immunogenicity will be evaluated prior to vaccination and at 28 days after vaccination using the hemagglutination inhibition (HAI) technique. For each influenza vaccine strain, pre and post vaccination geometric mean titers (GMTs) were calculated.|Day 0 and Day 28 after final vaccination|The immunogenicity population includes all randomized subjects who received a dose of study vaccine, provided serum samples for baseline (Day 0) and Day 28 HAI titers (within the specified windows) and have no major protocol deviations that might have adversely affect the immune response.||titer||95% Confidence Interval|Geometric Mean
641877|NCT02290509|Secondary|Number of Participants With Serious Adverse Events (SAEs) and Medically-attended Adverse Events (MAEs)||Six months post-vaccination|The safety population includes all randomized and vaccinated subjects who provided any safety data (solicited or unsolicited) following administration of study vaccine.||participants|||Number
641935|NCT02288312|Primary|Cmax (BIA 2-005)|Cmax (BIA 2-005) - maximum observed plasma drug concentration of BIA 2-005 (BIA 2-093 metabolite)|pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours postdose.|||ng/mL||Standard Deviation|Mean
641879|NCT02290509|Primary|Seroconversion to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine|Seroconversion is defined as: Either a pre vaccination titer < 10 (1/dil) and a post vaccination titer ≥ 40 (1/dil), or a pre vaccination titer ≥ 10 (1/dil) and a ≥ 4 fold increase in post vaccination titer at Day 28 after the final vaccination.|Day 28 after final vaccination|The immunogenicity population includes all randomized subjects who received a dose of study vaccine, provided serum samples for baseline (Day 0) and Day 28 HAI titers (within the specified windows) and have no major protocol deviations that might have adversely affect the immune response.||percentage of participants||95% Confidence Interval|Number
641880|NCT02289989|Secondary|Rate Skin Tolerance of Topical Agents|The patient or caregiver rated how well the patient tolerated the product after applying it on day 7 and 14. The scale was excellent, good, moderate and poor.|On day 7 and 14|||participants|||Number
641881|NCT02289989|Secondary|Rate Cosmetic Acceptability of Topical Agents|The patient or caregiver rated how the product felt on their skin after applying the product, measuring the cosmetic acceptability on day 7 and 14. The scale was excellent, good, moderate and poor.|On day 7 and 14|||participants|||Number
641882|NCT02289989|Secondary|Measure Presence of S. Aureus Colonization on Affected Skin|Bacterial culture of the affected area was done on day 0 and day 14.|Baseline to day 14|||participants|||Number
641883|NCT02289989|Primary|Histological Improvement Measured by Confocal Microscopy|Confocal microscopy was done to the patient on day 0, day 14 and day 28. Due to technical difficulties, this outcome measure was not collected.|Baseline to day 28|Data not collected|||||
641884|NCT02289989|Primary|Change of the Clinical Efficacy Rated by a Study Physician|Physician was asked to grade four characteristics: erythema, infiltration/papulation, excoriation and lichenification. The grade was none (0), mild (1), moderate (2) and severe (3).|Baseline to day 28|||participants|||Number
641885|NCT02289989|Primary|The Clinical Efficacy Rated by the Patient or Caregiver on Days 0 and 25|"This was measured with two questions. The first one referred to the description of the lesion and it included six characteristics: clear, dry, scaly, redness, cracks/opening and oozing. The second questions asked to grade how itchy was the patient.
All characteristics were measured on a scale from 0 to 5 (0 none, 5 extremely bothered/losing sleep)."|From baseline to day 25|||participants|||Number
641886|NCT02289963|Secondary|Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Apo A-1 ITT population.||percent change||Standard Error|Least Squares Mean
641887|NCT02289963|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 were obtained from multiple imputation approach followed by a robust regression model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|ITT population.||percent change||Standard Error|Mean
641888|NCT02289963|Secondary|Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|HDL-C ITT population.||percent change||Standard Error|Least Squares Mean
641889|NCT02289963|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 12- ITT Analysis|Adjusted means and standard errors at Week 12 were obtained from multiple imputation approach followed by robust regression model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|ITT population.||percent change||Standard Error|Mean
641890|NCT02289963|Secondary|Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline Apo A-1 value on- or off-treatment (Apo A-1 ITT population).||percent change||Standard Error|Least Squares Mean
641891|NCT02289963|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 were obtained from multiple imputation approach followed by robust regression model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|ITT population.||percent change||Standard Error|Mean
641892|NCT02289963|Secondary|Percent Change From Baseline in High Density Lipoprotein (HDL-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline HDL-C value on- or off-treatment (HDL-C ITT population).||percent change||Standard Error|Least Squares Mean
641893|NCT02289963|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 were obtained from multiple imputation approach followed by robust regression model for handling of missing data. All available post-baseline data up to Week 24 regardless of status on- or off-treatment were included in the imputation model.|From Baseline to Week 24|ITT population.||percent change||Standard Error|Mean
641894|NCT02289963|Secondary|Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-treatment Analysis|Adjusted percentages at Week 24 were obtained from multiple imputation approach model including available post-baseline on-treatment data up to Week 24 (i.e. up to 21 days after last injection).|From Baseline to Week 24|mITT population.||percentage of participants|||Number
641895|NCT02289963|Secondary|Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis|Adjusted percentages at Week 24 were obtained from multiple imputation approach model for handling of missing data. All available post-baseline data up to Week 24 regardless of status on- or off-treatment were included in the imputation model.|From Baseline to Week 24|ITT population.||percentage of participants|||Number
641896|NCT02289963|Secondary|Percent Change From Baseline in Total-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Total-C ITT population.||percent change||Standard Error|Least Squares Mean
641898|NCT02289963|Secondary|Percent Change From Baseline in Apo B at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Apo B ITT population.||percent change||Standard Error|Least Squares Mean
641899|NCT02289963|Secondary|Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline Total-C value on- or off-treatment (Total-C ITT population).||percent change||Standard Deviation|Least Squares Mean
641900|NCT02289963|Secondary|Percent Change From Baseline in Non-HDL-C at Week 24 - On-treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data up to Week 24 (i.e. up to 21 days after last injection).|From Baseline to Week 24|Participants of the mITT population with one baseline and at least one post-baseline non-HDL-C value on-treatment (non-HDL-C mITT population).||percent change||Standard Deviation|Least Squares Mean
641901|NCT02289963|Secondary|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment (non-HDL-C ITT population).||percent change||Standard Error|Least Squares Mean
641902|NCT02289963|Secondary|Percent Change From Baseline in Apo B at Week 24 - On-treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data up to Week 24 (i.e. up to 21 days after last injection).|From Baseline to Week 24|Participants of the mITT population with one baseline and at least one post-baseline Apo B value on-treatment (Apo B mITT population).||percent change||Standard Error|Least Squares Mean
641903|NCT02289963|Secondary|Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline Apo B value on- or off-treatment (Apo B ITT population).||percent change||Standard Error|Least Squares Mean
641904|NCT02289963|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including available post-baseline on-treatment data up to Week 24 (i.e. up to 21 days after last injection).|From Baseline to Week 24|mITT population.||percent change||Standard Error|Least Squares Mean
641905|NCT02289963|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|ITT population.||percent change||Standard Error|Least Squares Mean
641906|NCT02289963|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data up to Week 24 (i.e. up to 21 days after last injection) (on-treatment analysis).|From Baseline to Week 24|Modified ITT (mITT) population that included all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.||Percent Change||Standard Error|Least Squares Mean
641907|NCT02289963|Primary|Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis|Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data up to Week 24 regardless of status on- or off-treatment were used in the model (ITT analysis).|From Baseline to Week 24|ITT population that included all randomized participants with one baseline and at least one post-baseline calculated LDL-C on- or off-treatment.||percent change||Standard Error|Least Squares Mean
641908|NCT02289755|Secondary|Percent Change From Baseline Period to Treatment Period in 24-hour Urinary Oxalate Excretion|Percent Change from Baseline is defined as baseline value (average of Days 2 and 3) minus ALLN-177 treatment value (mean of Days 5, 6, and 7) divided by baseline value times 100%|7 days|All Participants (N=16) were included in the analysis.||percentage change||Standard Deviation|Mean
641909|NCT02289755|Primary|Change From Baseline Period to Treatment Period 24-hour Urinary Oxalate Excretion|Change from Baseline is defined as Baseline value (average of Days 2 and 3) minus ALLN-177 treatment value (mean of Days 5, 6, and 7).|7 days|All Participants (N=16) completed treatment and were included in the analysis population.||mg/day||Standard Deviation|Mean
641910|NCT02289742|Secondary|Percentage of Subjects With Wettability Grade of 2 or 3 After 8 Hours of Wear|A video was made to capture a visual demonstration of tear film characteristics in between blinks. The investigator graded contact lens surface wettability using a scale from 0 (fully wettable) to 3 (clearly visible distortions) at 5, 10, 15, 20 and 25 seconds post-blink by region (central, superior, nasal, inferior, and temporal). Three independent measurements (3 blinks) were carried out. An average was taken over the 3 measurements, 5 regions, and 5 time points. One eye contributed to the analysis.|Hour 8, each product|This analysis population includes all randomized and exposed subjects with data at visit.||percentage of subjects|||Number
641911|NCT02289742|Primary|Percentage of Subjects With Wettability Grade of 2 or 3 After 12 Hours of Wear|A video was made to capture a visual demonstration of tear film characteristics in between blinks. The investigator graded contact lens surface wettability using a scale from 0 (fully wettable) to 3 (clearly visible distortions) at 5, 10, 15, 20 and 25 seconds post-blink by region (central, superior, nasal, inferior, and temporal). Three independent measurements (3 blinks) were carried out. An average was taken over the 3 measurements, 5 regions, and 5 time points. One eye contributed to the analysis.|Hour 12, each product|This analysis population includes all randomized and exposed subjects with data at visit.||percentage of subjects|||Number
641936|NCT02288273|Secondary|Average of Change in 24-hour Mean Weighted Glucose From Baseline to Week 4 and Baseline to Week 10||Week 4 and Week 10|||% times patients had specific CGM/24-hr||Standard Error|Least Squares Mean
641937|NCT02288273|Secondary|Change in HbA1c From Baseline to Day 22 and Baseline to Day 70||Day 22 and Day 70|||% Alc||Standard Error|Least Squares Mean
641912|NCT02289469|Secondary|Patient Understanding|"Assessment of patient understanding of their medication regimen using 4 questions:
I understand what medicines I am supposed to take.
I understand how much medicine I am supposed to take at a time.
I understand what time of day to take each of my medicines.
I understand what each of my medicines is for. Participants had the following response options: Strongly Disagree, Disagree, Neutral, Agree, Strongly Agree Due to formatting restrictions on this site and the results being nearly identical for each question, only answers to question 1 are reported below."|1 week|A convenience sample of 50 intervention patients was contacted by phone approximately 1 week after Emergency Department discharge to rate their understanding of their medication regimen.||Participants|||Count of Participants
641913|NCT02289469|Primary|Number of Participants With Changes/Updates in Medication List|Participants for whom nurses made updates or corrections to the medication history in electronic health record|1 day|||Participants|||Count of Participants
641914|NCT02289105|Other Pre-specified|Participant Selections on ADs and Declination Forms||Baseline - up to 1 year||||||
641915|NCT02289105|Secondary|Proportion of Participants Who Return a Signed AD|This measures the proportion of participants who return a signed and printed copy of their AD of those who completed an AD online.|Baseline - up to 1 year|||proportion of participants||95% Confidence Interval|Number
641916|NCT02289105|Secondary|Proportion of Participants Who Already Have ADs||Baseline - up to 1 year|||proportion of participants|||Number
641917|NCT02289105|Primary|Proportion of Participants That Select to Complete an Advance Directive|We will analyze the effects of the active choice intervention on rates of completion.|Baseline - up to 1 year|||proportion of participants||95% Confidence Interval|Number
641918|NCT02289079|Secondary|Patient Satisfaction as Assessed Via Patient Survey|To determine if liposomal bupivacaine improves quality of recovery post-operatively when compared to bupivacaine when injected in a TAP block via a patient survey either in person or via telephone.|assessed at 72 hours after injection|||participants satisfied with pain control|||Number
641919|NCT02289079|Secondary|Post Operative Length of Stay|To determine if liposomal bupivacaine provides decreased length of stay when compared to bupivacaine when injected in a TAP block|up to 30 days after surgery|||Hours||Standard Deviation|Mean
641920|NCT02289079|Secondary|Numerical Rating Scale|This was a measure of patient's reported pain on a 0-10 verbal numerical rating scale. 10 being worst pain. The maximal value for the time period 48-72 hours was chosen as the maximal pain during that time period.|48-72 hours|||scores on a scale||Full Range|Median
641921|NCT02289079|Primary|Post Operative Opioid Use|To determine if liposomal bupivacaine provides decreased narcotic use when compared to bupivacaine when injected in a TAP block|0-72 hours after injection|||micrograms of fentanyl equivalents||Full Range|Median
641922|NCT02288364|Secondary|Pain|Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible.|immediately on completion of the final core biopsy specimen, within approximately 20 minutes of starting|Data not collected at this time point.|||||
641923|NCT02288364|Secondary|Pain|Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible.|immediately after obtaining the first core biopsy specimen, within approximately 15 minutes of starting|Data not collected at this time point.|||||
641924|NCT02288364|Secondary|Pain|Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible.|immediately prior to obtaining the first core biopsy specimen, within approximately 15 minutes of starting|Data not collected at this time point.|||||
641925|NCT02288364|Secondary|Pain|Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible.|30 seconds after initiating deep injection of the parenchyma (deeper breast tissue), within approximately 4 minutes of starting|Data not collected at this time point.|||||
641926|NCT02288364|Secondary|Pain|Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible.|immediately prior to injection of “deep” anesthesia in the breast parenchyma, within approximately 4 minutes of starting|Data not collected at this time point.|||||
641927|NCT02288364|Secondary|Pain|Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible.|30 seconds after initiating superficial injection in the subcutaneous tissue, within approximately 1 minute of starting|Data not collected at this time point.|||||
641928|NCT02288364|Secondary|Pain|Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible.|immediately on completion of the biopsy, within approximately 20 minutes of starting|||units on a scale||Standard Deviation|Mean
641929|NCT02288364|Secondary|Pain|Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible.|immediately on completion of anesthetizing the parenchyma (deeper breast tissue), within approximately 4 minutes of starting|||units on a scale||Standard Deviation|Mean
641930|NCT02288364|Secondary|Pain|Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible.|immediately on completion of anesthetizing the skin, within approximately 1 minute of starting|||units on a scale||Standard Deviation|Mean
641931|NCT02288364|Primary|Pain|Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible.|immediately prior to anesthetizing, within approximately 1 minute of starting|||units on a scale||Standard Deviation|Mean
641932|NCT02288312|Secondary|AUC0-∞ (BIA 2-005)|AUC0-∞ (BIA 2-005) - the area under the plasma BIA 2-005 concentration versus time curve from time zero to infinity, calculated from AUC0-t + (Clast/λz), where Clast is the last quantifiable concentration and λz the apparent terminal rate constant; (BIA 2-005 is a BIA 2-093 metabolite)|pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours postdose.|||ng.h/mL||Standard Deviation|Mean
641933|NCT02288312|Secondary|Tmax (BIA 2-005)|tmax (BIA 2-005) - the time of occurrence of Cmax of BIA 2-005 (BIA 2-005 is a BIA 2-093 metabolite)|pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours postdose.|||hours||Standard Deviation|Mean
641934|NCT02288312|Secondary|AUC0-t (BIA 2-005)|AUC0-t (BIA 2-005) - the area under the plasma concentration-time curve from time zero to the last sampling time at which BIA 2-005 concentrations are at or above the limit of quantification, calculated by the linear trapezoidal rule (BIA 2-005 is a BIA 2-093 metabolite)|pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours postdose.|||ng.h/mL||Standard Deviation|Mean
641943|NCT02288091|Secondary|Blood Biomarkers (FRAP) at Baseline and Week 12|Blood samples will be obtained at baseline and after 12 weeks of treatment to measure biomarkers of oxidative stress and damage such as ferric reducing antioxidant power (FRAP).|12 weeks|One (1) subject did not have blood drawn for FRAP analysis at the Baseline Visit. Four (4) subjects did not have blood drawn for FRAP analysis at the Week 12 visit. These missing samples are due to technical issues, such as a difficult blood draw or issue with sample processing.||µM||Standard Deviation|Mean
641944|NCT02288091|Secondary|Neuroimaging Biomarkers at Baseline and Week 12|Magnetic resonance spectroscopy (MRS) will be performed to measure the levels of glutathione in the motor cortex; levels of glutathione at Week 12 (post-treatment) will be compared to pre-treatment levels.|12 weeks|Five (5) subjects did not have a MRS done at the Baseline and Week 12 visits. Of the 20 that had a baseline MRS, 2 patients did not have a Week 12 MRS done. These missing MRS scans are due to technical difficulties, such as subjects were unable to complete the scan.||mM||Standard Deviation|Mean
641945|NCT02288091|Secondary|Blood Biomarkers (GSH) at Baseline and Week 12|Blood samples will be obtained at baseline and after 12 weeks of treatment to measure biomarkers of oxidative stress and damage such as glutathione (GSH).|12 weeks|Two (2) subjects did not have blood drawn for GSH analysis at the Baseline Visit. Five (5) subjects did not have blood drawn for GSH analysis at the Week 12 visit. These missing samples are due to technical issues, such as a difficult blood draw or issue with sample processing.||ƥM||Standard Deviation|Mean
641946|NCT02288091|Primary|Tolerability to Complete the Entire 12 Week Study on Study Drug.|Tolerability will be defined as the ability of subjects to complete the entire 12-week study on study drug.|12 weeks|Twenty-four (24) out of twenty-five (25) participants completed 12 weeks of study drug treatment.||Participants|||Count of Participants
641947|NCT02288091|Primary|Number of Participants Experiencing Adverse Events|Safety will be assessed by the occurrence of adverse events.|12 weeks|No expected adverse events of special interest, such as kidney stones and gout, occurred during the course of the study. However, twenty-two (22) out of twenty-five (25) participants did experience an adverse event during the course of the study.||Participants|||Count of Participants
641948|NCT02287779|Secondary|Area Under the Plasma Concentration-Time Curve (AUC) of Volixibat (SHP626)||Day 1 to Day 14|Pharmacokinetic set. Due to minimal absorption of volixibat no participant had sufficient and interpretable primary pharmacokinetic data.|||||
641949|NCT02287779|Secondary|Maximum Observed Plasma Concentration (Cmax) of Volixibat||Day 1 to Day 14|Pharmacokinetic set consisted of all participants in the safety analysis set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Due to minimal absorption of volixibat no participant had sufficient and interpretable primary pharmacokinetic data.|||||
641950|NCT02287779|Secondary|Number of Participants With Stool Hardness Using Bristol Stool Chart|Stool hardness was assessed after each evacuation using the bristol stool chart, a medical aid designed to classify the form of human feces into 7 categories where type 1 is the hardest and type 7 is the softest.|Day -2 to Day 14|Pharmacodynamic set.||participants|||Number
641951|NCT02287779|Secondary|Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration|Serum 7- alpha-hydroxy-4-cholesten-3-one (C4) concentrations were reported.|Day -1 to Day 15|Pharmacodynamic set.||nanogram per milliliter||Standard Deviation|Mean
641952|NCT02287779|Secondary|Average Total Fecal Bile Acid (FBA) Concentration|Stool samples for the determination of total FBA were collected in 48-hour windows from 48 hours before dosing on Day 1 through Day 14. The average of daily total FBA excretion is calculated before (Day -1 and Day -2) as the first pre dose of IMP and after (Day 1-12) as the first post-dose of IMP. The FBA is calculated as Total FBA (micromoles) = FBA (micromol per liter) * weight (grams) divided by 10^3. Participants with fecal bile acid concentration and their average pre-first dose and average post-first dose were reported.|Day -2 up to Day 14|Pharmacodynamic set consisted of all participant in the safety analysis set for whom the primary pharmacodynamic data were considered sufficient and interpretable.||nanomoles*gram per liter||Standard Deviation|Mean
641953|NCT02287779|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Who Discontinued From the Study|TEAEs were defined as events that either had a start date on or after the first dose of IMP or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An AE that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE.|From the start of the study drug administration up to 9 days after the last dose of study drug administration|Safety analysis set.||participants|||Number
641954|NCT02287779|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs)|TEAEs were defined as events that either had a start date on or after the first dose of IMP or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An AE that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE.|From the start of the study drug administration up to 9 days after the last dose of study drug administration|Safety analysis set.||participants|||Number
641955|NCT02287779|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Electrocardiogram (12-lead)|TEAEs were defined as events that either had a start date on or after the first dose of IMP or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An AE that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE. Twelve lead electrocardiogram parameters [(heart rate (HR), PR, RR, QRS and QT intervals and information on T-wave morphology (normal/abnormal) and U-wave morphology (absent/normal or abnormal)] were assessed.|From the start of the study drug administration up to 9 days after the last dose of study drug administration|Safety analysis set.||participants|||Number
641956|NCT02287779|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Vital Signs|TEAEs were defined as events that either had a start date on or after the first dose of IMP or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An AE that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE. Vital signs parameter included evaluation of orthostatic blood pressure, respiratory rate and body temperature.|From the start of the study drug administration up to 9 days after the last dose of study drug administration|Safety analysis set.||participants|||Number
641957|NCT02287779|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Urinalysis Parameters|TEAEs were defined as events that either had a start date on or after the first dose of IMP or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An AE that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE. Urinalysis parameters included evaluation of pH, glucose, protein, nitrites, leukocyte esterase, occult blood, ketones, bilirubin and specific gravity levels.|From the start of the study drug administration up to 9 days after the last dose of study drug administration|Safety analysis set.||participants|||Number
641958|NCT02287779|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Standard Chemistry|TEAEs were defined as events that either had a start date on or after the first dose of IMP or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An AE that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE. Standard chemistry parameters included evaluation of sodium, potassium, glucose, blood urea nitrogen, creatinine, calcium, chloride, thyrotropin, thyroxine, tri-iodothyronine, phosphorus, protein, bicarbonate or carbon dioxide, albumin, aspartate aminotransferase, alanine aminotransferase, gamma-glutamyltransferase, alkaline phosphatase, total bilirubin, urate, beta-human chorionic gonadotropin and follicle-stimulating hormone levels. Participant with TEAE related to standard chemistry were reported with hepatic enzyme increase.|From the start of the study drug administration up to 9 days after the last dose of study drug administration|Safety analysis set||participants|||Number
641959|NCT02287779|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Coagulation|TEAEs were defined as events that either had a start date on or after the first dose of IMP or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An AE that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE. Coagulation included international normalized ratio, activated partial thromboplastin time and prothrombin time.|From the start of the study drug administration up to 9 days after the last dose of study drug administration|Safety analysis set.||participants|||Number
641960|NCT02287779|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Thyroid Hormone Panel|TEAEs were defined as events that either had a start date on or after the first dose of IMP or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An AE that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE. Thyroid hormone panel parameters included evaluation of thyroid hormones (TSH [thyroid stimulating hormone]; T3 [triiodothyronine] and T4 [thyroxine]).|From the start of the study drug administration up to 9 days after the last dose of study drug administration|Safety analysis set.||participants|||Number
641961|NCT02287779|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Lipid Panel|TEAEs were defined as events that either had a start date on or after the first dose of IMP or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An AE that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE. Lipid panel parameters included evaluation of total cholesterol, triglycerides, high-density lipoprotein (HDL) cholesterol, very low-density lipoprotein (VLDL) cholesterol and low-density lipoprotein (LDL) cholesterol.|From the start of the study drug administration up to 9 days after the last dose of study drug administration|Safety analysis set.||participants|||Number
641962|NCT02287779|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Fat Soluble Vitamins (Vitamin A, D, & E)|TEAEs were defined as events that either had a start date on or after the first dose of IMP or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An AE that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE. Fat soluble vitamin included vitamin A (serum retinol), vitamin D (serum 25-hydroxycholecalciferol) and vitamin E (serum alfa-tocopherol).|From the start of the study drug administration up to 9 days after the last dose of study drug administration|Safety analysis set.||participants|||Number
641963|NCT02287779|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Standard Hematology|TEAEs were defined as events that either had a start date on or after the first dose of investigational medicinal product (IMP) or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An adverse event (AE) that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE. Hematology parameters included evaluation of hemoglobin, hematocrit, red blood cells, platelets, white blood cell count; total and differential, neutrophils (absolute), eosinophils (absolute), monocytes (absolute), basophils (absolute) and lymphocytes (absolute).|From the start of the study drug administration up to 9 days after the last dose of study drug administration|Safety analysis set included all participants for whom a randomization number was assigned and who had taken >= 1 dose of IMP.||participants|||Number
641964|NCT02287623|Secondary|Post Operative Opioid Use|Post operative opioid use from 0-24 hours after surgery.|0-24 hours|||micrograms of fentanyl equivalents||Inter-Quartile Range|Median
641965|NCT02287623|Secondary|Postoperative Opioid Use|Use of opioids during 24-48 hours after surgery|24-48 hours|||Micrograms of fentanyl equivalents||Inter-Quartile Range|Median
641966|NCT02287623|Secondary|Post Operative Length of Stay||up to 30 days after surgery|||HOURS||Inter-Quartile Range|Median
641967|NCT02287623|Secondary|Number of Patients With Post Operative Nausea/Vomiting||0-72 hours|||participants|||Number
641968|NCT02287623|Secondary|Post Operative Opioid Use||48-72 hours|||micrograms of fentanyl equivalents||Inter-Quartile Range|Median
641969|NCT02287623|Primary|Numerical Rating Scale|This was a measure of patient's reported pain on a 0-10 verbal numerical rating scale. 10 being worst pain. The maximal value for the time period 48-72 hours was chosen as the maximal pain during that time period.|48-72 hours after injection|||scores on a scale||Inter-Quartile Range|Median
641970|NCT02287610|Other Pre-specified|Correlation Between Vectra DA and DAS28 at Each Assessed Time Point|Vectra DA and DAS28 data were collected, however not analyzed or correlated.|Baseline to Last Follow up visit (up to 18.7 weeks)|Analysis and correlations were not completed for this outcome measure.|||||
641973|NCT02287610|Secondary|Corticosteroid Sparing Effect - Change in Total Daily Prednisone Dose From Baseline to Final Visit (Final Follow-up Visit)|The change in total daily prednisone from baseline to follow-up (whether the patient was taking RAYOS or returned to conventional prednisone) was calculated for all participants.|Baseline to Last Follow up visit (up to 18.7 weeks)|||milligrams||Standard Deviation|Mean
641974|NCT02287610|Secondary|Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Recent Medical History Component From Baseline to Final Visit (Final Follow-up Visit)|Multidimensional Health Assessment Questionnaire (MDHAQ) – recent medical history was gathered using a medical history checklist and was calculated by summing the total number of items checked “Yes” (0 to 12 items could be checked). A negative change from baseline indicates fewer items were checked at the follow-up visit. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in MDHAQ recent medical history was only calculated for participants that had measurements at both baseline and final follow-up.|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Multidimensional Health Assessment Questionnaire (MDHAQ) – recent medical history was calculated for participants who had both baseline and follow-up recent medical history data. For this measure, the mean change from baseline is based on 33 participants.||number of items checked||Standard Deviation|Mean
641975|NCT02287610|Secondary|Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Fatigue (FAT) Component From Baseline to Final Visit (Final Follow-up Visit)|Multidimensional Health Assessment Questionnaire (MDHAQ) – fatigue (FAT) scoring was gathered using a 0-10 scale where 0 corresponded to “Fatigue is no problem” and 10 to “Fatigue is a major problem” over the past week. A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in fatigue was only calculated for participants that had measurements at both baseline and final follow-up.|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Multidimensional Health Assessment Questionnaire (MDHAQ) – fatigue (FAT) was calculated for participants who had both baseline and follow-up FAT data. For this measure, the mean change from baseline is based on 33 participants.||units on a scale||Standard Deviation|Mean
641976|NCT02287610|Secondary|Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Exercise (EX) Component From Baseline to Final Visit (Final Follow-up Visit)|The exercise aerobically for at least one-half hour (30 minutes) measure of the multidimensional health assessment questionnaire (MDHAQ) was scored as follows: “3 or more times a week” (3), “1-2 times per week” (2), “1-2 times per month” (1), “Do not exercise regularly” (0), “Cannot exercise due to disability/handicap” (-1). As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in MDHAQ exercise measure was only calculated for participants that had measurements at both baseline and final follow-up.|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Multidimensional Health Assessment Questionnaire (MDHAQ) – exercise (EX) was calculated for participants who had both baseline and follow-up EX data. For this measure, the mean change from baseline is based on 33 participants.||units on a scale||Standard Deviation|Mean
641977|NCT02287610|Secondary|"Change in Multidimensional Health Assessment Questionnaire (MDHAQ) How do You Feel Today (Compared to One Week Ago) Component From Baseline to Final Visit (Final Follow-up Visit)"|The Multidimensional Health Assessment Questionnaire (MDHAQ) – how do you feel today compared to one week ago question was scored as follows: 1: Much Better, 2: Better, 3: The Same, 4: Worse, 5: Much Worse. A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in “How do you feel” measure was only calculated for participants that had measurements at both baseline and final follow-up.|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Multidimensional Health Assessment Questionnaire - How do you feel today (compared to 1wk ago) from Baseline to Final Visit was calculated for participants who had both baseline and follow-up data. For this measure, the mean change from baseline is based on 33 participants.||units on a scale||Standard Error|Mean
641978|NCT02287610|Secondary|Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Morning Stiffness Component From Baseline to Final Visit (Final Follow-up Visit)|The duration of morning stiffness was the amount of time participants experienced stiffness after waking up in the morning (over the last week). This measure was collected at baseline and at the last follow-up visit. A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in duration of morning stiffness was only calculated for participants that had measurements at both baseline and final follow-up.|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Multidimensional Health Assessment Questionnaire (MDHAQ) – morning stiffness, minutes (past week) was calculated for participants who had both baseline and follow-up data. For this measure, the mean change from baseline is based on 30 participants.||minutes||Standard Deviation|Mean
641979|NCT02287610|Secondary|Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Review of Symptoms (ROS) Component From Baseline to Final Visit (Final Follow-up Visit)|Multidimensional Health Assessment Questionnaire (MDHAQ) – review of symptoms (ROS) was gathered using a symptom checklist and was calculated by summing the total number of items checked (0 to 60 symptoms could be checked). A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in MDHAQ ROS was only calculated for participants that had measurements at both baseline and final follow-up.|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Multidimensional Health Assessment Questionnaire (MDHAQ) – review of symptoms (ROS) was calculated for participants who had both baseline and follow-up ROS data. For this measure, the mean change from baseline is based on 33 participants.||number of symptoms||Standard Deviation|Mean
642011|NCT02287402|Secondary|Time to Progression to Type 2 Diabetes Mellitus in the Treatment Period Calculated Using the Cumulative Incidence Function|"The cumulative progression rate (percentage of participants) was calculated using the cumulative incidence function for the time to progression to type 2 diabetes mellitus in the treatment period in the Full Analysis Set."|Day 168, 336, 504, and 672|Full Analysis Set - All participants who received at least 1 dose of open-label study drug.||percentage of participants|||Number
641980|NCT02287610|Secondary|Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Patient Global Assessment (PTGL) Component From Baseline to Final Visit (Final Follow-up Visit)|Multidimensional Health Assessment Questionnaire (MDHAQ) – patient global assessment (PTGL) was measured by asking the participant to rate on a 0 to 10 scale how they were doing considering all of the ways in which their illness and health conditions affected them: 0 - Very Well, 10 - Very Poor. A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in PTGL was only calculated for participants that had measurements at both baseline and final follow-up.|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Multidimensional Health Assessment Questionnaire (MDHAQ) – patient global assessment (PTGL) was calculated for participants who had both baseline and follow-up PTGL data. For this measure, the mean change from baseline is based on 33 participants.||units on a scale||Standard Deviation|Mean
641981|NCT02287610|Secondary|Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Neck and Back (NB) Component From Baseline to Final Visit (Final Follow-up Visit)|For the Multidimensional Health Assessment Questionnaire (MDHAQ) – neck and back (NB), participants were asked to score the amount of pain they were experiencing in their neck and back as “None” (score of 0), “Mild” (score of 1), “Moderate” (score of 2) or “Severe” (score of 3). The raw 0-6 score was adjusted to 0-10. A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in NB measure was only calculated for participants that had measurements at both baseline and final follow-up.|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Multidimensional Health Assessment Questionnaire (MDHAQ) – neck and back (NB) was calculated for participants who had both baseline and follow-up NB data. For this measure, the mean change from baseline is based on 33 participants.||units on a scale||Standard Deviation|Mean
641982|NCT02287610|Secondary|Change in Multidimensional Health Assessment Questionnaire (MDHAQ) the Rheumatoid Arthritis Disease Activity Index (RADAI) Patient Self-report Joint Count (PTJT) Component From Baseline to Final Visit (Final Follow-up Visit)|For the Change in Multidimensional Health Assessment Questionnaire (MDHAQ) – the Rheumatoid Arthritis disease Activity Index (RADAI) patient self-report joint count (PTJT), participants were asked to score the amount of pain they were experiencing in each of 16 joints (left joint, left wrist, right shoulder etc.) as “None” (score of 0), “Mild” (score of 1), “Moderate” (score of 2) or “Severe” (score of 3). The raw 0-48 score is adjusted to 0-10 using a scoring template. A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in PTJT was only calculated for participants that had measurements at both baseline and final follow-up.|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Multidimensional Health Assessment Questionnaire (MDHAQ) – RADAI patient self-report joint count (PTJT) was calculated for participants who had both baseline and follow-up data. For this measure, the mean change from baseline is based on 33 participants.||units on a scale||Standard Deviation|Mean
641983|NCT02287610|Secondary|Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Pain (PN) Component From Baseline to Final Visit (Final Follow-up Visit)|Multidimensional Health Assessment Questionnaire (MDHAQ) – pain (PN) scoring was gathered using a 0-10 scale where 0 corresponded to “No Pain” and 10 to “Pain as bad as it could be” because of the condition (over the past week). A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in pain was only calculated for participants that had measurements at both baseline and final follow-up.|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Multidimensional Health Assessment Questionnaire (MDHAQ) – Pain (PN) was calculated for participants who had both baseline and follow-up PN data. For this measure, the mean change from baseline is based on 33 participants.||units on a scale||Standard Deviation|Mean
641984|NCT02287610|Secondary|Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Psychological Status (PS) Component From Baseline to Final Visit (Final Follow-up Visit)|The change in Multidimensional Health Assessment Questionnaire (MDHAQ) – Psychological status (PS) was assessed by asking participants to score how they were sleeping, dealing with anxiety/nervousness, and dealing with depression as “without any difficulty” (score of 0), “with some difficulty” (score of 1.1), “with much difficulty” (score of 2.2) or “unable to do” (score of 3.3). The results were summed to give a score ranging from 0 to 9.9. A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in psychological status was only calculated for participants that had measurements at both baseline and final follow-up.|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Multidimensional Health Assessment Questionnaire (MDHAQ) – Psychological status (PS) was calculated for participants who had both baseline and follow-up PS data. For this measure, the mean change from baseline is based on 33 participants.||units on a scale||Standard Deviation|Mean
641985|NCT02287610|Secondary|Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Function (FN) Component From Baseline to Final Visit (Final Follow-up Visit)|The change in Multidimensional Health Assessment Questionnaire (MDHAQ) – function (FN) was assessed by asking participants to score the performance of multiple activities as “without any difficulty” (score of 0), “with some difficulty” (score of 1), “with much difficulty” (score of 2) or “unable to do” (score of 3). The results were summed and divided by 3 to give a score from 0 to10. A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in function was only calculated for participants that had measurements at both baseline and final follow-up.|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Multidimensional Health Assessment Questionnaire (MDHAQ) – Function (FN) was calculated for participants who had both baseline and follow-up FN data. For this measure, the mean change from baseline is based on 33 participants.||units on a scale||Standard Deviation|Mean
642136|NCT02284854|Primary|Cmax (CBZE) - the Maximum Plasma Concentration|"Reference - Day 28 following twice-daily oral administration of CBZ 400 mg twice-daily Test - Day 35 following twice-daily oral administration of CBZ 400 mg twice-daily
CBZE - carbamazepine-epoxide is the active metabolite of CBZ"|Day 28 to 35|||ng/mL||Standard Deviation|Mean
641986|NCT02287610|Secondary|Change in Routine Assessment of Patient Index Data (RAPID3) From Baseline to Final Visit (Final Follow-up Visit)|"Routine Assessment of Patient Index Data (RAPID3) was calculated by summing three measures: physical function (0 to 10 with higher scores indicating less function), pain (0 to 10 with higher scores indicating higher pain), and patient global assessment (0 to 10 with higher scores indicating the participant was doing very poorly considering the ways in which the illness was affecting them). As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in RAPID3 was only calculated for participants that had measurements at both baseline and final follow-up.
RAPID3 scores range from 0 to 30 with higher scores meaning worse condition. A negative change from baseline indicates improvement in condition."|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Routine Assessment of Patient Index Data (RAPID3) was calculated for participants who had both baseline and follow-up data required to calculate RAPID3. For this measure, the mean change from baseline is based on 33 participants.||units on a scale||Standard Deviation|Mean
641987|NCT02287610|Secondary|ACR-N From Baseline to Final Visit (Final Follow-up Visit)|ACR-N is the index of improvement in rheumatoid arthritis, and is defined as the lowest of 3 values: percent change in the number of swollen joints (scored 0-28 with higher scores indicating higher disease activity), percent change in the number of tender joints (scored 0-28 with higher scores indicating higher disease activity), and the median of the other 5 measures in the American College of Rheumatology core data set–Patient’s global assessment (PGA, scored on a 1-10 scale with higher scores indicating higher disease activity), physician’s global assessment (PhGA, scored on a 1-10 scale with higher scores indicating higher disease activity), pain scale (scored on a 1-10scale with higher scores indicating higher pain), functional questionnaire (scored on a 1-10 scale with higher scores indicating less function), and acute phase reactant (Erythrocyte Sedimentation Rate or C-reactive Protein). Positive percent change indicates improvement. Negative percent change indicates worsening.|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. There were 27 participants with insufficient information to calculate ACR-N scores and 5 participants have only baseline data. ACR-N calculations were performed on data from 24 participants.||percent change||Standard Deviation|Mean
641988|NCT02287610|Secondary|Percentage of Participants With American College of Rheumatology 70% Improvement (ACR70) Response From Baseline to Final Visit (Final Follow-up Visit)|American College of Rheumatology (ACR) 70 a patient must demonstrate a >= 70% improvement in tender and swollen joints (each scored 0-28 with higher scores indicating higher disease activity) as well as a 70% improvement in at least 3 of the following 5 parameters: patient global assessment (PGA, scored on a 1-10 scale with higher scores indicating higher disease activity), physician global assessment (PhGA, scored on a 1-10 scale with higher scores indicating higher disease activity), pain scale (scored on a 1-10 scale with higher scores indicating higher pain), functional questionnaire (scored on a 1-10 scale with higher scores indicating less function), and acute phase reactant (Erythrocyte Sedimentation Rate or C-reactive Protein).|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. There were 27 participants with insufficient information to calculate ACR70 response and 5 participants have only baseline data. The percentages were calculated based on 56 participants.||percentage of particpants|||Number
641989|NCT02287610|Secondary|Percentage of Participants With American College of Rheumatology 50% Improvement (ACR50) Response From Baseline to Final Visit (Final Follow-up Visit)|American College of Rheumatology (ACR) 50, a patient must demonstrate a >= 50% improvement in tender and swollen joints (each scored 0-28 with higher scores indicating higher disease activity) as well as a 50% improvement in at least 3 of the following 5 parameters: patient global assessment (PGA, scored on a 1-10 scale with higher scores indicating higher disease activity), physician global assessment (PhGA, scored on a 1-10 scale with higher scores indicating higher disease activity), pain scale (scored on a 1-10 scale with higher scores indicating higher pain), functional questionnaire (scored on a 1-10 scale with higher scores indicating less function), and acute phase reactant (Erythrocyte Sedimentation Rate or C-reactive Protein).|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. There were 27 participants with insufficient information to calculate ACR20 response and 5 participants have only Baseline data. The percentages were calculated based on 56 participants.||percentage of participants|||Number
641990|NCT02287610|Secondary|Percentage of Participants With American College of Rheumatology 20% Improvement (ACR20) Response From Baseline to Final Visit (Final Follow-up Visit)|American College of Rheumatology (ACR) 20, a patient must demonstrate a >= 20% improvement in tender and swollen joints (each scored 0-28 with higher scores indicating higher disease activity) as well as a 20% improvement in at least 3 of the following 5 parameters: patient global assessment (PGA, scored on a 1-10 scale with higher scores indicating higher disease activity), physician global assessment (PhGA, scored on a 1-10 scale with higher scores indicating higher disease activity), pain scale (scored on a 1-10 scale with higher scores indicating higher pain), functional questionnaire (scored on a 1-10 scale with higher scores indicating less function), and acute phase reactant (Erythrocyte Sedimentation Rate or C-reactive Protein).|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. There were 27 participants with insufficient information to calculate ACR20 response and 5 participants have only baseline data. The percentages were calculated based on 56 participants.||percentage of participants|||Number
641991|NCT02287610|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Response From Baseline to Final Visit (Final Follow-up Visit)|"European League Against Rheumatism (EULAR) response is based on change (improvement) in Disease Activity Score in 28 Joints score from baseline to last follow-up visit. DAS28 scores were broken into 3 categories: ≤3.2 at last follow-up (low disease activity), >3.2 and ≤ 5.1 at last follow-up (moderate or high disease activity), and DAS28 >5.1 at last follow-up (high disease activity). Then based on the category and magnitude of the change in DAS28 from baseline, the EULAR response of Good, Moderate or No Response was determined.
DAS28 is an index for measuring disease activity in rheumatoid arthritis (RA). The index includes swollen joint counts (SJC) and tender joint counts (TJC), both scored 0-28 (higher scores indicate higher disease activity), as well as acute phase response determined as erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP), and patient global assessment (PGA) on a visual analogue scale (higher scores indicate higher disease activity)."|Baseline to Last Follow up visit (up to 18.7 weeks)|||percentage of participants|||Number
641992|NCT02287610|Secondary|Change in Simple Disease Activity Index (SDAI) From Baseline to Final Visit (Final Follow-up Visit)|Simple Disease Activity Index (SDAI) is the sum of the following 5 components to assess rheumatoid arthritis severity: Swollen Joint Count 28 (SJC28, scored 0-28 with higher scores indicating higher disease activity) + Tender Joint Count 28 (TJC28, scored 0-28 with higher scores indicating higher disease activity) + Patient Global Assessment (PGA, scored on a visual analogue scale from 1-10 cm with higher scores indicating higher disease activity) + Physician Global Assessment (PhGA, scored on a visual analogue scale from 1-10 cm with higher scores indicating higher disease activity) + C-reactive Protein (CRP). SDAI scores indicate whether a participant is in remission or low, moderate or high activity. A negative change in SDAI indicates improvement.|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Simple Disease Activity Index (SDAI) was calculated for participants who had both baseline and follow-up data required to calculate SDAI. For this measure, the mean change from baseline is based on 25 participants.||units on a scale||Standard Deviation|Mean
641993|NCT02287610|Secondary|Change in Clinical Disease Activity Index (CDAI) From Baseline to Final Visit (Final Follow-up Visit)|"Clinical Disease Activity Index (CDAI) is the sum of 4 parameters: Swollen Joint Count 28 (SJC28, scored 0-28 with higher scores indicating higher disease activity) + Tender Joint Count 28 (TJC28, scored 0-28 with higher scores indicating higher disease activity) + Patient Global Assessment (PGA, scored on a visual analogue scale from 1-10 cm with higher scores indicating higher disease activity) + Physician Global Assessment (PhGA, scored on a visual analogue scale from 1-10 cm with higher scores indicating higher disease activity). CDAI scores range from 0 to 76 and indicate whether a participant is in remission or low, moderate or high activity; higher scores indicate higher disease activity. A negative change from baseline indicates improvement in condition.
As this study was a non-interventional research initiative and no assessments/visits were mandated, the change in CDAI was only calculated for participants that had both baseline and final follow-up measurements."|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Clinical Disease Activity Index (CDAI) was calculated for participants who had both baseline and follow-up data required to calculate CDAI. For this measure, the mean change from baseline is based on 33 participants.||units on a scale||Standard Deviation|Mean
641994|NCT02287610|Secondary|Change in Disease Activity Score in 28 Joints Calculated With C-reactive Protein (DAS28-CRP) From Baseline to Final Visit (Final Follow-up Visit)|"The DAS28 is an index for measuring disease activity in rheumatoid arthritis (RA). The index includes swollen joint counts (SJC) and tender joint counts (TJC), both scored 0-28 (higher scores indicate higher disease activity), as well as acute phase response determined by erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP), and patient global assessment (PGA) on a visual analogue scale (higher scores indicate higher disease activity).
DAS28-CRP was calculated according to the following formula: DAS28-CRP equals (=) [0.56 multiplied by (*) the square root (√) of TJC] plus (+) [0.28 * √ of SJC] + [0.36 * the natural logarithm (ln) of (CRP + 1)] + [0.014 * PGA in mm] + 0.96. A negative change from baseline indicated improvement.
As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in DAS28-CRP was only calculated for participants that had measurements at both baseline and final follow-up."|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Disease Activity Score in 28 Joints calculated with C-reactive protein (DAS28-CRP) was calculated for participants who had both baseline and follow-up data required to calculate DAS28-CRP. For this measure, the mean change from baseline is based on 25 participants.||units on a scale||Standard Deviation|Mean
641995|NCT02287610|Secondary|Change in Disease Activity Score in 28 Joints Calculated With Erythrocyte Sedimentation Rate (DAS28-ESR) From Baseline to Final Visit (Final Follow-up Visit)|"The DAS28 is an index for measuring disease activity in rheumatoid arthritis (RA). The index includes swollen joint counts (SJC) and tender joint counts (TJC), both scored 0-28 (higher scores indicate higher disease activity), as well as acute phase response determined by erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP), and patient global assessment (PGA) on a visual analogue scale (higher scores indicate higher disease activity).
DAS28-ESR was calculated according to the following formula: DAS28-ESR equals (=) [0.56 multiplied by (*) the square root (√) of TJC] plus (+) [0.28 * √ of SJC] + [0.70 * the natural logarithm (ln) ESR in millimeters per hour (mm/h)] + [0.014 * PGA in mm]. A negative change from baseline indicates improvement.
As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in DAS28-ESR was only calculated for participants that had measurements at both baseline and final follow-up."|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in DAS28-ESR was calculated for participants who had both baseline and follow-up data required to calculate DAS28-ESR. For this measure, the mean change from baseline is based on 15 participants.||units on a scale||Standard Deviation|Mean
641996|NCT02287610|Secondary|Change in Physician’s Overall Assessment in Disease Activity From Baseline to Final Visit (Final Follow-up Visit)|Physician’s Overall Assessment in Disease Activity was measured with a 10-cm visual analogue scale (VAS) where 0 corresponded to “Very Well’ and 10 to “Very Poor”. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in Physician’s Overall Assessment in Disease Activity was only calculated for participants that had measurements at both baseline and final follow-up.|Baseline to Last Follow-up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Physician’s Overall Assessment in Disease Activity was calculated for participants who had both baseline and follow-up Physician’s Overall Assessment in Disease Activity data. For this measure, the mean change from baseline is based on 37 participants.||units on a scale||Standard Deviation|Mean
642012|NCT02287402|Secondary|Time to Progression to Type 2 Diabetes Mellitus in the Treatment Period Calculated by the Kaplan-Meier Method|"The cumulative progression rate (percentage of participants) was calculated by the Kaplan-Meier method for the time to progression to Type 2 Diabetes mellitus in the treatment period in the Full Analysis Set."|Day 168, 336, 504, and 672|Full Analysis Set - All participants who received at least 1 dose of open-label study drug.||percentage of participants|||Number
641997|NCT02287610|Secondary|Change in Patient’s Overall Assessment in Disease Activity From Baseline to Final Visit (Final Follow-up Visit)|Patient’s Overall Assessment in Disease Activity was measured by asking the participant to rate on a 10-cm visual analogue scale (VAS) how well they were doing considering all of the ways their arthritis affected them: 0 - Very Well, 10 - Very Poor. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in Patient’s Overall Assessment in Disease Activity was only calculated for participants that had measurements at both baseline and final follow-up.|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Patient’s Overall Assessment in Disease Activity was calculated for participants who had both baseline and follow-up Patient’s Overall Assessment in Disease Activity data. For this measure, the mean change from baseline is based on 36 participants.||units on a scale||Standard Deviation|Mean
641998|NCT02287610|Secondary|Change in Duration of Morning Stiffness (Minutes) From Baseline to Final Visit (Final Follow-Up Visit)|The duration of morning stiffness was the amount of time participants experienced stiffness after getting up in the morning. This measure was collected at baseline and at the last follow-up visit. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in duration of morning stiffness was only calculated for participants that had measurements at both baseline and final follow-up.|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. The change in duration of morning stiffness (minutes) was calculated for participants who had both baseline and follow-up morning stiffness data. For duration of morning stiffness, the mean change from baseline is based on 41 participants.||minutes||Standard Deviation|Mean
641999|NCT02287610|Primary|Mean Change in Severity of Morning Stiffness (Using 100mm VAS) From Baseline (Week 0) to Final Follow-Up Visit|Mean change in severity of morning stiffness was assessed using a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0 corresponded to “Not Severe at All” and 100 to “Extremely Severe”. This measure was collected at baseline and at the last follow-up visit. As this study was a non-interventional research initiative and no assessments or visits were mandated, the mean change was only calculated for participants that had measurements at both baseline and final follow-up.|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Mean change in severity of morning stiffness was calculated for participants who had both baseline and follow-up severity of morning stiffness data. For severity of morning stiffness, the mean change from baseline is based on 38 participants.||units on a scale||Standard Deviation|Mean
642000|NCT02287415|Secondary|AUCτ - Steady-state Area Under the Plasma Concentration-time Profile Over 24 h, the Dosing Interval||PHASE A: first 3 days; PHASE B: Days 1, 2, 4, 6, 7 and 8: pre-dose. PHASE C: Days 1, 3, 5 and 7: pre-dose; Day 8: 24 h post last-warfarin dose.|||ng.h/mL||Standard Deviation|Mean
642001|NCT02287415|Secondary|Tmax - Time of Occurrence of Cmax||PHASE A: first 3 days; PHASE B: Days 1, 2, 4, 6, 7 and 8: pre-dose. PHASE C: Days 1, 3, 5 and 7: pre-dose; Day 8: 24 h post last-warfarin dose.|||hours||Full Range|Median
642002|NCT02287415|Primary|Cmax - Maximum Steady-state Plasma Concentration||PHASE A: first 3 days; PHASE B: Days 1, 2, 4, 6, 7 and 8: pre-dose. PHASE C: Days 1, 3, 5 and 7: pre-dose; Day 8: 24 h post last-warfarin dose.|||ng/mL||Standard Deviation|Mean
642003|NCT02287402|Secondary|Body Weight at Follow-up|"Summary statistics were calculated at each assessment time point for the HbA1c in patients who proceeded to the follow-up in the Full Analysis Set."|Follow-up at Week 0, 12, 24, 36, and 48|Participants from the Full Analysis Set, all participants who received at least 1 dose of open-label study drug, and continued to Follow-up.||kg||Standard Deviation|Mean
642004|NCT02287402|Secondary|Body Weight|"Summary statistics were calculated at each assessment time point for the body weight in the Full Analysis Set."|Week 0, 12, 24, 48, 72, 96, 120, and the end of the treatment period|Full Analysis Set - All participants who received at least 1 dose of open-label study drug.||kg||Standard Deviation|Mean
642005|NCT02287402|Secondary|HbA1c at Follow-up|"Summary statistics were calculated at each assessment time point for the HbA1c in patients who proceeded to the follow-up in the Full Analysis Set."|Follow-up at Week 0, 12, 24, 36, and 48|Participants from the Full Analysis Set, all participants who received at least 1 dose of open-label study drug, and continued to Follow-up.||percent||Standard Deviation|Mean
642006|NCT02287402|Secondary|Hemoglobin A1c (HbA1c)|"Summary statistics were calculated at each assessment time point for the HbA1c in the Full Analysis Set."|Week 0, 12, 24, 48, 72, 96, 120, and the end of the treatment period.|Full Analysis Set - All participants who received at least 1 dose of open-label study drug.||percent||Standard Deviation|Mean
642007|NCT02287402|Secondary|2-Hour Plasma Glucose During 75 g OGTT at Follow-up|"Summary statistics were calculated at each assessment time point for the 2-hour plasma glucose during 75 g OGTT in participants who proceeded to the follow-up in the Full Analysis Set."|Follow-up at week 0, 12, 24, 36, and 48|Participants from the Full Analysis Set, all participants who received at least 1 dose of open-label study drug, and continued to Follow-up.||mg/dL||Standard Deviation|Mean
642008|NCT02287402|Secondary|2-Hour Plasma Glucose During 75 g Oral Glucose Tolerance Test (OGTT)|"Summary statistics were calculated at each assessment time point for the 2-hour plasma glucose during 75 g OGTT in the Full Analysis Set."|Week 0, 24, 48, 72, 96, 120, and the end of the treatment period|Full Analysis Set - All participants who received at least 1 dose of open-label study drug.||mg/dL||Standard Deviation|Mean
642009|NCT02287402|Secondary|Time to Improvement to Normoglycemia in the Treatment Period Measured Values by the Cumulative Incidence Function|"The cumulative progression rate (percentage of participants) was calculated using the cumulative incidence function for the time to improvement to normoglycemia in the treatment period in the Full Analysis Set."|Day 168, 336, 504, and 672|Full Analysis Set - All participants who received at least 1 dose of open-label study drug.||percentage of participants|||Number
642010|NCT02287402|Secondary|Time to Improvement to Normoglycemia in the Treatment Period Calculated by the Kaplan-Meier Method|"The cumulative progression rate (percentage of participants) was calculated by the Kaplan-Meier method for the time to improvement to normoglycemia in the treatment period in the Full Analysis Set."|Day 168, 336, 504, and 672|Full Analysis Set - All participants who received at least 1 dose of open-label study drug.||percentage of participants|||Number
642134|NCT02284854|Primary|AUC0-t (CBZ) - Area Under the Curve to Last Measurable Concentration for CBZ|Reference - Day 28 following twice-daily oral administration of CBZ 400 mg Test - Day 35 following twice-daily oral administration of CBZ 400 mg|Day 28 to 35|||ng*h/mL||Standard Deviation|Mean
642013|NCT02287402|Primary|Assessment of Diabetic Status in Follow-up (Type 2 Diabetes Mellitus, Normoglycemia, or IGT)|"Frequency tabulations of the assessment of diabetic status in the follow-up (Type 2 Diabetes mellitus, normoglycemia, or IGT) were prepared in patients who proceeded to the follow-up in the Full Analysis Set."|Follow-up at Week 12, 24, 36, and 48|Participants from the Full Analysis Set, all participants who received at least 1 dose of open-label study drug, and continued to Follow-up.||participants|||Number
642014|NCT02287402|Primary|Assessment of Diabetic Status in the Treatment Period (Type 2 Diabetes Mellitus, Normoglycemia, or Impaired Glucose Tolerance (IGT)|"Frequency tabulations of the assessment of diabetic status in the treatment period (Type 2 Diabetes mellitus, normoglycemia, or IGT) were prepared in the Full Analysis Set."|Treatment period: Up to 122 weeks. Treatment was to be ended when patients were assessed as Type 2 Diabetes Mellitus or normoglycemic.|Full Analysis Set - All participants who received at least 1 dose of open-label study drug.||participants|||Number
642015|NCT02287376|Secondary|Safety Outcome (7 of 7)|• Physical examination findings including abnormal clinically significant findings|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.
The data presented is a clinically significant change from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."||Participants|||Count of Participants
642016|NCT02287376|Secondary|Safety Outcome (6.24 of 7)|• Changes in clinical laboratory results: Urinalysis - Specific Gravity.|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.
The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."||Specific Gravity||Standard Deviation|Mean
642017|NCT02287376|Secondary|Safety Outcome (6.23 of 7)|• Changes in clinical laboratory results: Urinalysis - pH.|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.
The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."||pH||Standard Deviation|Mean
642018|NCT02287376|Secondary|Safety Outcome (6.22 of 7)|• Changes in clinical laboratory results: Chemistry - Sodium (mmol/L).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.
The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."||mmol/L||Standard Deviation|Mean
642019|NCT02287376|Secondary|Safety Outcome (6.21 of 7)|• Changes in clinical laboratory results: Chemistry - Potassium (mmol/L).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.
The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."||mmol/L||Standard Deviation|Mean
642020|NCT02287376|Secondary|Safety Outcome (6.20 of 7)|• Changes in clinical laboratory results: Chemistry - LDH (U/L).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.
The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."||U/L||Standard Deviation|Mean
642021|NCT02287376|Secondary|Safety Outcome (6.19 of 7)|• Changes in clinical laboratory results: Chemistry - Glucose (mmol/L).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.
The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."||mmol/L||Standard Deviation|Mean
642022|NCT02287376|Secondary|Safety Outcome (6.18 of 7)|• Changes in clinical laboratory results: Chemistry - Creatinine (umol/L).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.
The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."||umol/L||Standard Deviation|Mean
642023|NCT02287376|Secondary|Safety Outcome (6.17 of 7)|• Changes in clinical laboratory results: Chemistry - Chloride (mmol/L).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.
The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."||mmol/L||Standard Deviation|Mean
642024|NCT02287376|Secondary|Safety Outcome (6.16 of 7)|• Changes in clinical laboratory results: Chemistry - BUN (Urea) (mmol/L).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.
The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."||mmol/L||Standard Deviation|Mean
642025|NCT02287376|Secondary|Safety Outcome (6.15 of 7)|• Changes in clinical laboratory results: Chemistry - Bilirubin Total (umol/L).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.
The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."||umol/L||Standard Deviation|Mean
642026|NCT02287376|Secondary|Safety Outcome (6.14 of 7)|• Changes in clinical laboratory results: Chemistry - Bicarbonate (CO2) (mmol/L).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.
The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."||mmol/L||Standard Deviation|Mean
642027|NCT02287376|Secondary|Safety Outcome (6.13 of 7)|• Changes in clinical laboratory results: Chemistry - AST (SGOT) (U/L).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.
The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."||U/L||Standard Deviation|Mean
642135|NCT02284854|Primary|AUC0-t (BIA 2-093) - Area Under the Curve to Last Measurable Concentration for BIA 2-093|Reference - Day 7 following once-daily oral administration of ESL 800 mg Test - Day 35 following once-daily oral administration of ESL 800 mg|Day 7 to 35|||ng*h/mL||Standard Deviation|Mean
642028|NCT02287376|Secondary|Safety Outcome (6.12 of 7)|• Changes in clinical laboratory results: Chemistry - ALT (SGPT) (U/L).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.
The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."||U/L||Standard Deviation|Mean
642029|NCT02287376|Secondary|Safety Outcome (6.11 of 7)|• Changes in clinical laboratory results: Chemistry - Alkaline Phosphatase (U/L).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.
The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."||U/L||Standard Deviation|Mean
642030|NCT02287376|Secondary|Safety Outcome (6.10 of 7)|• Changes in clinical laboratory results: Chemistry - Albumin (g/L).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.
The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."||g/L||Standard Deviation|Mean
642031|NCT02287376|Secondary|Safety Outcome (6.9 of 7)|• Changes in clinical laboratory results: Hematology - Monocytes (%).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.
The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."||% Monocytes||Standard Deviation|Mean
642032|NCT02287376|Secondary|Safety Outcome (6.8 of 7)|• Changes in clinical laboratory results: Hematology - Lymphocytes (%).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.
The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."||% Lymphocytes||Standard Deviation|Mean
642033|NCT02287376|Secondary|Safety Outcome (6.7 of 7)|• Changes in clinical laboratory results: Hematology - Neutrophils (%).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.
The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."||% Neutrophils||Standard Deviation|Mean
642034|NCT02287376|Secondary|Safety Outcome (6.6 of 7)|• Changes in clinical laboratory results: Hematology - Eosinophils (%).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.
The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."||% Eosinophils||Standard Deviation|Mean
642035|NCT02287376|Secondary|Safety Outcome (6.5 of 7)|• Changes in clinical laboratory results: Hematology - Basophils (%).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.
The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."||% Basophils||Standard Deviation|Mean
642036|NCT02287376|Secondary|Safety Outcome (6.4 of 7)|• Changes in clinical laboratory results: Hematology - White Blood Cells (Cells * 10^9/L).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.
The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."||Cells * 10^9/L||Standard Deviation|Mean
642037|NCT02287376|Secondary|Safety Outcome (6.3 of 7)|• Changes in clinical laboratory results: Hematology - Platelet Count (Cells * 10^9/L).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.
The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."||Cells * 10^9/L||Standard Deviation|Mean
642038|NCT02287376|Secondary|Safety Outcome (6.2 of 7)|• Changes in clinical laboratory results: Hematology - Hemoglobin (g/L).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.
The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."||g/L||Standard Deviation|Mean
642039|NCT02287376|Secondary|Safety Outcome (6.1 of 7)|• Changes in clinical laboratory results: Hematology - Hematocrit (L/L).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.
The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."||L/L||Standard Deviation|Mean
642040|NCT02287376|Secondary|Safety Outcome (5.5 of 7)|• Changes in vital sign measurements: Diastolic Blood Pressure (mmHg).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.
The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."||mm Hg||Standard Deviation|Mean
642041|NCT02287376|Secondary|Safety Outcome (5.4 of 7)|• Changes in vital sign measurements: Systolic Blood Pressure (mmHg).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.
The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."||mm Hg||Standard Deviation|Mean
642042|NCT02287376|Secondary|Safety Outcome (5.3 of 7)|• Changes in vital sign measurements: Respiratory Rate (breaths/min).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.
The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."||breaths/min||Standard Deviation|Mean
642043|NCT02287376|Secondary|Safety Outcome (5.2 of 7)|• Changes in vital sign measurements: Heart Rate (beats/min).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.
The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."||beats/min||Standard Deviation|Mean
642044|NCT02287376|Secondary|Safety Outcome (5.1 of 7)|• Changes in vital sign measurements: Temperature (degrees C).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.
The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."||degrees C||Standard Deviation|Mean
642045|NCT02287376|Secondary|Safety Outcome (4 of 7)|• Deaths|3 months (signed informed consent/assent to 30 days post Day 90 or last dose of study medication taken)|The Safety population included all subjects who have received at least 1 dose of study drug.||Participants|||Count of Participants
642046|NCT02287376|Secondary|Safety Outcome (3 of 7)|• Withdrawals due to AEs|3 months (signed informed consent/assent to 30 days after the last dose of study medication taken)|The Safety population included all subjects who have received at least 1 dose of study drug.||Participants|||Count of Participants
642047|NCT02287376|Secondary|Safety Outcome (2 of 7)|• Serious adverse events (SAEs)|3 months (signed informed consent/assent to 30 days post Day 90 or last dose of study medication taken)|The Safety population included all subjects who have received at least 1 dose of study drug.||Participants|||Count of Participants
642048|NCT02287376|Secondary|Safety Outcome (1 of 7)|• Treatment emergent AEs (TEAEs)|3 months (time of first dose of study medication taken to 30 days after the last dose of study medication taken)|The Safety population included all subjects who have received at least 1 dose of study drug.||Participants|||Count of Participants
642049|NCT02287376|Primary|Pharmacokinetics Outcome (6 of 6)|• AUC 0-∞: area under the concentration-time curve from time 0 to infinity (∞) (min*ng/mL)|6 hours (pre-dose, 5, 10, 15, 20, 30, 40, and 60 min, and 2, 4, and 6 hrs post-dose)|The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing.||min*ng/mL||Standard Deviation|Mean
642050|NCT02287376|Primary|Pharmacokinetics Outcome (5 of 6)|• AUC 0-t: area under the concentration-time curve from time 0 to last time point (t) where diclofenac could be measured (min*ng/mL)|6 hours (pre-dose, 5, 10, 15, 20, 30, 40, and 60 min, and 2, 4, and 6 hrs post-dose)|The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing.||min*ng/mL||Standard Deviation|Mean
642051|NCT02287376|Primary|Pharmacokinetics Outcome (4 of 6)|• t1/2: terminal elimination half-life (min)|6 hours (pre-dose, 5, 10, 15, 20, 30, 40, and 60 min, and 2, 4, and 6 hrs post-dose)|The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing.||min||Standard Deviation|Mean
642052|NCT02287376|Primary|Pharmacokinetics Outcome (3 of 6)|• λz: elimination rate constant associated with the terminal (log linear) portion of the curve (1/min)|6 hours (pre-dose, 5, 10, 15, 20, 30, 40, and 60 min, and 2, 4, and 6 hrs post-dose)|The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing.||1/min||Standard Deviation|Mean
642053|NCT02287376|Primary|Pharmacokinetics Outcome (2 of 6)|• tmax: time to maximum concentration (min)|6 hours (pre-dose, 5, 10, 15, 20, 30, 40, and 60 min, and 2, 4, and 6 hrs post-dose)|The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing.||min||Standard Deviation|Mean
642054|NCT02287376|Primary|Pharmacokinetics Outcome (1 of 6)|• Cmax: maximum concentration (ng/mL)|6 hours (pre-dose, 5, 10, 15, 20, 30, 40, and 60 min, and 2, 4, and 6 hrs post-dose)|The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing.||ng/mL||Standard Deviation|Mean
642055|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (7 of 7).|• Physical examination findings including abnormal clinically significant findings|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.
The data presented is any new or worsened clinically significant abnormal change from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."||Participants|||Count of Participants
642056|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.24 of 7).|• Changes in clinical laboratory results: Urinalysis - Specific Gravity.|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.
The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."||Specific Gravity||Standard Deviation|Mean
642057|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.23 of 7).|• Changes in clinical laboratory results: Urinalysis - pH.|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.
The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."||pH||Standard Deviation|Mean
642058|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.22 of 7).|• Changes in clinical laboratory results: Chemistry - Sodium (mmol/L).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.
The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."||mmol/L||Standard Deviation|Mean
642059|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.21 of 7).|• Changes in clinical laboratory results: Chemistry - Potassium (mmol/L).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.
The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."||mmol/L||Standard Deviation|Mean
642173|NCT02283840|Primary|AUC0-t - the Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time||prior to and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 24, 48 and 72 hours after drug administration|||ng.h/mL||Standard Deviation|Mean
642060|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.20 of 7).|• Changes in clinical laboratory results: Chemistry - LDH (U/L).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.
The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."||U/L||Standard Deviation|Mean
642061|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.19 of 7).|• Changes in clinical laboratory results: Chemistry - Glucose (mmol/L).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.
The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."||mmol/L||Standard Deviation|Mean
642062|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.18 of 7).|• Changes in clinical laboratory results: Chemistry - Creatinine (umol/L).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.
The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."||umol/L||Standard Deviation|Mean
642063|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.17 of 7).|• Changes in clinical laboratory results: Chemistry - Chloride (mmol/L).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.
The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."||mmol/L||Standard Deviation|Mean
642064|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.16 of 7).|• Changes in clinical laboratory results: Chemistry - BUN (Urea) (mmol/L).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.
The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."||mmol/L||Standard Deviation|Mean
642065|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.15 of 7).|• Changes in clinical laboratory results: Chemistry - Bilirubin Total (umol/L).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.
The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."||umol/L||Standard Deviation|Mean
642066|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.14 of 7).|• Changes in clinical laboratory results: Chemistry - Bicarbonate (CO2) (mmol/L).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.
The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."||mmol/L||Standard Deviation|Mean
642067|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.13 of 7).|• Changes in clinical laboratory results: Chemistry - AST (SGOT) (U/L).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.
The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."||U/L||Standard Deviation|Mean
642068|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.12 of 7).|• Changes in clinical laboratory results: Chemistry - ALT (SGPT) (U/L).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.
The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."||U/L||Standard Deviation|Mean
642069|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.11 of 7).|• Changes in clinical laboratory results: Chemistry - Alkaline Phosphatase (U/L).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.
The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."||U/L||Standard Deviation|Mean
642070|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.10 of 7).|• Changes in clinical laboratory results: Chemistry - Albumin (g/L).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.
The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."||g/L||Standard Deviation|Mean
642071|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.9 of 7).|• Changes in clinical laboratory results: Hematology - Monocytes (%).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.
The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."||% Monocytes||Standard Deviation|Mean
642174|NCT02283840|Primary|Cmax BIA 2-005 - the Maximum Plasma Concentration of BIA 2-005||prior to and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 24, 48 and 72 hours after drug administration|||ng/mL||Standard Deviation|Mean
642072|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.8 of 7).|• Changes in clinical laboratory results: Hematology - Lymphocytes (%).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.
The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."||% Lymphocytes||Standard Deviation|Mean
642073|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.7 of 7).|• Changes in clinical laboratory results: Hematology - Neutrophils (%).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.
The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."||% Neutrophils||Standard Deviation|Mean
642074|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.6 of 7).|• Changes in clinical laboratory results: Hematology - Eosinophils (%).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.
The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."||% Eosinophils||Standard Deviation|Mean
642075|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.5 of 7).|• Changes in clinical laboratory results: Hematology - Basophils (%).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.
The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."||% Basophils||Standard Deviation|Mean
642076|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.4 of 7).|• Changes in clinical laboratory results: Hematology - White Blood Cells (10^9/L).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.
The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."||10^9/L||Standard Deviation|Mean
642077|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.3 of 7).|• Changes in clinical laboratory results: Hematology - Platelet Count (10^9/L).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.
The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."||10^9/L||Standard Deviation|Mean
642078|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.2 of 7).|• Changes in clinical laboratory results: Hematology - Hemoglobin (g/L).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.
The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."||g/L||Standard Deviation|Mean
642079|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.1 of 7).|• Changes in clinical laboratory results: Hematology - Hematocrit (L/L).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.
The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."||L/L||Standard Deviation|Mean
642080|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5.5 of 7).|• Changes in vital sign measurements: Diastolic Blood Pressure (mmHg).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.
The data presented are changes from baseline to the final visit. Baseline is defined as the last non-missing measurement taken before first treatment with study drug."||mmHg||Standard Deviation|Mean
642081|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5.4 of 7).|• Changes in vital sign measurements: Systolic Blood Pressure (mmHg).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.
The data presented are changes from baseline to the final visit. Baseline is defined as the last non-missing measurement taken before first treatment with study drug."||mmHg||Standard Deviation|Mean
642082|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5.3 of 7).|• Changes in vital sign measurements: Respiratory Rate (breaths/min).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.
The data presented are changes from baseline to the final visit. Baseline is defined as the last non-missing measurement taken before first treatment with study drug."||breaths/min||Standard Deviation|Mean
642083|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5.2 of 7).|• Changes in vital sign measurements: Pulse Rate (beats/min).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.
The data presented are changes from baseline to the final visit. Baseline is defined as the last non-missing measurement taken before first treatment with study drug."||beats/min||Standard Deviation|Mean
648267|NCT02107014|Primary|Change in IL-31 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].|||pg/mL||95% Confidence Interval|Median
642084|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5.1 of 7).|• Changes in vital sign measurements: Temperature (degrees C).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.
The data presented are changes from baseline to the final visit. Baseline is defined as the last non-missing measurement taken before first treatment with study drug."||degrees C||Standard Deviation|Mean
642085|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (4 of 7).|• Deaths|4 weeks (signed informed consent/assent to 30 days after the last dose of study drug)|The Safety population included all subjects who have received at least 1 dose of study drug.||Participants|||Count of Participants
642086|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (3 of 7).|• Withdrawals due to AEs|4 weeks (signed informed consent/assent to 30 days after the last dose of study drug)|The Safety population included all subjects who have received at least 1 dose of study drug.||Participants|||Count of Participants
642087|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (2 of 7).|• Serious adverse events (SAEs)|4 weeks (signed informed consent/assent to 30 days after the last dose of study drug)|The Safety population included all subjects who have received at least 1 dose of study drug.||Participants|||Count of Participants
642088|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (1 of 7).|• Treatment emergent AEs (TEAEs)|4 weeks (first dose of study drug and up to 30 days after the date of the last dose of study drug)|The Safety population included all subjects who have received at least 1 dose of study drug.||Participants|||Count of Participants
642089|NCT02287350|Primary|To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (8 of 8).|• Vz/F: apparent volume of distribution (mL).|6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)|The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing.||mL||Standard Deviation|Mean
642090|NCT02287350|Primary|To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (7 of 8).|• CL/F: apparent clearance (mL/hr).|6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)|The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing.||mL/hr||Standard Deviation|Mean
642091|NCT02287350|Primary|To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6 of 8).|• AUC 0-∞: area under the concentration-time curve from time 0 to infinity (∞) (hr*ng/mL)|6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)|The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing.||hr*ng/mL||Standard Deviation|Mean
642092|NCT02287350|Primary|To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5 of 8).|• AUC 0-t: area under the concentration-time curve from time 0 to last time point (t) where diclofenac could be measured (hr*ng/mL)|6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)|The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing.||hr*ng/mL||Standard Deviation|Mean
642093|NCT02287350|Primary|To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (4 of 8).|• t1/2: terminal elimination half-life (hr)|6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)|The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing.||hr||Standard Deviation|Mean
642094|NCT02287350|Primary|To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (3 of 8).|• λz: elimination rate constant (1/hr)|6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)|The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing.||1/hr||Standard Deviation|Mean
642095|NCT02287350|Primary|To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (2 of 8).|• Tmax: time to maximum concentration (hr)|6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)|The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing.||hr||Full Range|Median
642096|NCT02287350|Primary|To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (1 of 8).|• Cmax: maximum concentration (ng/mL)|6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)|The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing.||ng/mL||Standard Deviation|Mean
642097|NCT02286518|Secondary|Urinary Excretion Ratio of TAK-114 From 0 to 48 Hours Postdose: Part 1|Urinary excretion ratio (% of dose) of TAK-114 in urine were calculated for each participant. Ratio was calculated from the urine concentrations of each analyte and the volume of urine collected.|Day 1: 0 to 48 hours postdose|The Pharmacokinetic (PK) analysis set includes all participants who had received the study drug and met the essential requirements defined in the study protocol without any critical protocol violations, and in whom PK assessment was possible.||percentage of dose||Standard Deviation|Mean
642098|NCT02286518|Secondary|Mean R(AUC): Mean of Accumulation Coefficient of Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for TAK-114: Part 3|Mean R(AUC) was estimated as the ratio of AUC(0-tau) on Day 10 and AUC(0-tau) on Day 1. AUC (0-tau) is the area under the plasma concentration-time curve from time 0 to time tau.|Days 1 and 10: predose and at multiple time points (up to 12 hours) postdose for Part 3|The Pharmacokinetic (PK) analysis set includes all participants who had received the study drug and met the essential requirements defined in the study protocol without any critical protocol violations, and in whom PK assessment was possible.||ratio||Standard Deviation|Mean
642099|NCT02286518|Secondary|Mean R(Cmax): Mean Accumulation Coefficient of Observed Maximum Plasma Concentration for TAK-114: Part 3|Mean R(Cmax) was estimated as the ratio of Cmax on Day 10 and Cmax on Day 1. Cmax is the peak plasma drug concentration of TAK-114.|Days 1 and 10: predose and at multiple time points (up to 12 hours) postdose for Part 3|The Pharmacokinetic (PK) analysis set includes all participants who had received the study drug and met the essential requirements defined in the study protocol without any critical protocol violations, and in whom PK assessment was possible.||ratio||Standard Deviation|Mean
642100|NCT02286518|Secondary|Mean Terminal Phase Elimination Half-life (T1/2) for TAK-114||Day1:predose and at multiple time-points (up to 48 hours) postdose for Part 1; Day1:predose and at multiple time-points (up to 48 hours) postdose in each period for Part 2; Day 10: predose and at multiple time points (up to 12 hours) postdose for Part 3|The Pharmacokinetic (PK) analysis set includes all participants who had received the study drug and met the essential requirements defined in the study protocol without any critical protocol violations, and in whom PK assessment was possible.||hour||Standard Deviation|Mean
642101|NCT02286518|Secondary|AUC (0-tau) - Area Under the Plasma Concentration-Time Curve From Time 0 to Time Tau for TAK-114: Part 3||Day10: predose and at multiple time points (up to 12 hours) postdose for Part 3|The Pharmacokinetic (PK) analysis set includes all participants who had received the study drug and met the essential requirements defined in the study protocol without any critical protocol violations, and in whom PK assessment was possible.||pg*hr/mL||Standard Deviation|Mean
642102|NCT02286518|Secondary|AUC (0-Infinity) - Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for Unchanged TAK-114: Part 1 and Part 2||Day 1: predose and at multiple time-points (up to 48 hours) postdose for Part 1; Day 1: predose and at multiple time-points (up to 48 hours) postdose in each period for Part 2|The Pharmacokinetic (PK) analysis set includes all participants who had received the study drug and met the essential requirements defined in the study protocol without any critical protocol violations, and in whom PK assessment was possible.||picogram*hour per milliliter (pg*hr/mL)||Standard Deviation|Mean
642103|NCT02286518|Secondary|Cmax - Maximum Observed Plasma Concentration for TAK-114||Day1: predose and at multiple time-points (up to 48 hours) postdose for Part 1; Day 1:predose and at multiple time-points (up to 48 hours) postdose in each period for Part 2; Day 10:predose and at multiple time points (up to 12 hours) postdose for Part 3|The Pharmacokinetic (PK) analysis set includes all participants who had received the study drug and met the essential requirements defined in the study protocol without any critical protocol violations, and in whom PK assessment was possible.||picogram per milliliter (pg/mL)||Standard Deviation|Mean
642104|NCT02286518|Primary|Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis||Baseline up to Day 3 in Part 1, Day 20 in Part 2 and Day 17 in Part 3|The safety analysis set includes all participants who received the study drug.||participants|||Number
642105|NCT02286518|Primary|Number of Participants With Clinically Meaningful Changes From Baseline in 12-lead Electrocardiograms (ECG)||Baseline up to Day 2 (only for Cohorts 1A, 2A, and 3A) in Part 1|The safety analysis set includes all participants who received the study drug.||participants|||Number
642106|NCT02286518|Primary|Number of Participants With Clinically Meaningful Changes From Baseline in 12-lead Electrocardiograms (ECG)|Number of participants who had ECG shifts from “within normal limit” at baseline to “abnormal, clinically significant” after study drug administration were reported.|Baseline up to Day 3 in Part 1, Day 20 in Part 2 and Day 17 in Part 3|The safety analysis set includes all participants who received the study drug.||participants|||Number
642107|NCT02286518|Primary|Number of Participants With TEAEs Related to Body Weight||Baseline up to Day 3 in Part 1, Day 20 in Part 2 and Day 17 in Part 3|The safety analysis set includes all participants who received the study drug.||participants|||Number
642108|NCT02286518|Primary|Number of Participants With TEAEs Related to Vital Signs||Baseline up to Day 3 in Part 1, Day 20 in Part 2 and Day 17 in Part 3|The safety analysis set includes all participants who received the study drug.||participants|||Number
642109|NCT02286518|Primary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)||Baseline up to 3 days after the last dose of study drug (Day 3 in Part 1), (Day 20 in Part 2) and 7 days after the last dose of study drug (Day 17 in Part 3)|The safety analysis set includes all participants who received the study drug.||participants|||Number
642110|NCT02286193|Secondary|Number of Participants Setting a Goal With Their CRS|Number of patients who completed at least one visit with the CRS and set a specific action-based goal with their CRS. Patients could meet with the CRS and receive referrals to resources without setting specific action-based goals. This was assessed by abstraction and coding of CRS documentation in the medical record.|3 months|||participants|||Number
642111|NCT02286193|Primary|Number of Participants Receiving a Resource for Community Services|Number of patients who completed at least one visit with the CRS and were given a referral for at least one resource, service, or organization. This was assessed by abstraction and coding of CRS documentation in the medical record.|3 months|||participants|||Number
642112|NCT02286102|Secondary|Hemoglobin Levels, Post-Op Day 2|Hemoglobin levels will be measured post-operatively day 2|2 days postop|||g/Dl (grams/deciliter)||Standard Deviation|Mean
642113|NCT02286102|Secondary|Hemoglobin Levels, Post-Op Day 3|Hemoglobin levels will be measured post-operatively day 3|3 days postop|||g/Dl (grams/deciliter)||Standard Deviation|Mean
642114|NCT02286102|Primary|Volume of Allogenic Blood Transfused Postoperatively|The total volume of allogenic blood transfused postoperatively will be measured during the first 48 hours postoperatively while the drains are in place.|48 hours postoperative|||mL||Standard Deviation|Mean
642125|NCT02285270|Secondary|Change in Total Brown Adipose Tissue FDG Uptake as Measured by Total Volume of Segmented Fat Times the Mean Standardized Uptake Value (SUVmean)||~12-hours|No patients were analyzed since no patient showed uptake of FDG in brown adipose tissue.|||||
642126|NCT02285270|Secondary|Correlation Between Cortisol Level and Brown Adipose Tissue FDG Uptake||~12-hours|No patients were analyzed since no patient showed uptake of FDG in brown adipose tissue.|||||
642127|NCT02285270|Primary|Change in Maximum Standardized Update Value (SUVmax) in Brown Adipose Tissue FDG Uptake in the Neck or Upper Chest on Evening and Imaging Compared to Morning Imaging||~12-hours|No patients were analyzed since no patient showed uptake of FDG in brown adipose tissue.|||||
642128|NCT02284880|Primary|AUC0-t - Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to the Last Sampling Time at Which Concentrations Were at or Above the Limit of Quantification|"Reference - MF - marketed formulation Test - TBM - to-be-marketed
BIA 2-005 - BIA 2-093 metabolite"|pre-dose then 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose on each dosing period|||ng.hr/ml||Standard Deviation|Mean
642129|NCT02284880|Primary|Tmax - Time of Occurrence of Cmax|"Reference - MF - marketed formulation Test - TBM - to-be-marketed
BIA 2-005 - BIA 2-093 metabolite"|pre-dose then 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose on each dosing period|||hours||Full Range|Median
642130|NCT02284880|Primary|Cmax - Maximum Plasma Concentration|Reference - MF - marketed formulation Test - TBM - to-be-marketed BIA 2-005 - BIA 2-093 metabolite|pre-dose then 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose on each dosing period|||ng/ml||Standard Deviation|Mean
642131|NCT02284867|Secondary|Comparison of CD16+ CD56 Dim Uterine Natural Killer Cells (uNK) Prevalence in Decidua vs. Villi in Placenta of Both Study Groups|CD16+ CD56dim uterine Natural Killer cells (uNK) in the villi was found in Preterm delivery Group.|2 years|||participants|||Number
642132|NCT02284867|Primary|Uterine Natural Killer Cells In Preterm Labor|Number of participants with CD16 orCD 56 uterine Natural Killer Cells positive staining of placental sample|2 years|||participants|||Number
642133|NCT02284854|Primary|AUC0-t (CBZE) - Area Under the Curve to Last Measurable Concentration for CBZE|"Reference - Day 28 following twice-daily oral administration of CBZ 400 mg Test - Day 35 following twice-daily oral administration of CBZ 400 mg
CBZE - carbamazepine-epoxide is the active metabolite of CBZ"|Day 28 to 35|||ng*h/mL||Standard Deviation|Mean
642524|NCT02273115|Secondary|Number of Participants With Time to Delivery Achieved Within 12 Hours|Number of participants with a time from Foley placement to delivery less than or equal to 12 hours|Within 12 hours|||Participants|||Count of Participants
642137|NCT02284854|Primary|Cmax (CBZ) - the Maximum Plasma Concentration|Reference - Day 28 following twice-daily oral administration of CBZ 400 mg Test - Day 35 following twice-daily oral administration of CBZ 400 mg|Day 28 to 35|||ng/mL||Standard Deviation|Mean
642138|NCT02284854|Primary|Cmax (BIA 2-093) - the Maximum Plasma Concentration|Reference - Day 7 following once-daily oral administration of ESL 800 mg Test - Day 35 following once-daily oral administration of ESL 800 mg|Day 7 to 35|||ng/mL||Standard Deviation|Mean
642139|NCT02284828|Primary|Total Reaction Time (TRT) (ms): Change From Baseline at Each Time Point During Acute Dosing Phase||-1, 3, 6, and 10 hours post-dose|||miliseconds||Standard Deviation|Mean
642140|NCT02284828|Primary|Total Reaction Time (TRT) (ms): Raw Values at Each Time Point During Acute Dosing Phase||-1, 3, 6, and 10 hours post-dose|||miliseconds||Standard Deviation|Mean
642141|NCT02284828|Primary|Recognition Reaction Time (RRT) (ms): Raw Values at Each Time Point During Acute Dosing Phase||-1, 3, 6, and 10 hours post-dose|||miliseconds||Standard Deviation|Mean
642142|NCT02284828|Primary|Recognition Reaction Time (RRT) (ms): Change From Baseline at Each Time Point During Acute Dosing Phase||-1, 3, 6, and 10 hours post-dose|||miliseconds||Standard Deviation|Mean
642143|NCT02284828|Primary|Motor Reaction Time (MRT) (ms): Raw Values at Each Time Point During Acute Dosing Phase||-1, 3, 6, and 10 hours post-dose|||miliseconds||Standard Deviation|Mean
642144|NCT02284828|Primary|Motor Reaction Time (MRT) (ms): Change From Baseline at Each Time Point During Acute Dosing Phase||-1, 3, 6, and 10 hours post-dose|||miliseconds||Standard Deviation|Mean
642145|NCT02284555|Secondary|The Number of Subjects With Adverse Events and Changes in Vital Signs, ECG and Routine Haematology, Clinical Chemistry and Urinalysis Tests Assessed Over the Five Day Treatment Period and Follow-up at 7 and 14 Days Relative to the First Dose.||5 day treatment period and follow-up at 7 and 14 days|||participants|||Number
642146|NCT02284555|Primary|Apparent Eradication of Nasal Carriage of SA|Apparent eradication demonstrated by a semi-quantitative score of negative or zero using a broth enriched culture microbial assay.|48 hours after the last dose of mupirocin 2%|||participants|||Number
642147|NCT02284516|Secondary|Change From Baseline in Patient-Reported Eye Dryness Score to Day 14 and Day 42|Eye dryness score was scored on a Visual Analogue Scale (VAS) ranges from 0-100 (0=no discomfort; 100=maximal discomfort).|Baseline to Day 14 and Day 42|ITT population with LOCF. Here, n = number of participants analyzed for the specific categories of each arm, respectively.||units on a scale||Standard Deviation|Mean
642148|NCT02284516|Primary|Change From Baseline in Patient-Reported Eye Dryness Score to Day 84|Eye dryness score was scored on a Visual Analogue Scale (VAS) ranges from 0-100 (0=no discomfort; 100=maximal discomfort).|Baseline to Day 84|Intent to treat (ITT) population included all randomized participants who took at least 1 dose of investigational product with last observation carried forward (LOCF). Here, n = number of participants analyzed for the specific categories of each arm, respectively.||units on a scale||Standard Deviation|Mean
642149|NCT02284386|Primary|The Apparent Terminal Elimination Half-life (t1/2el)||Baseline through Day 14|||hours||Standard Deviation|Mean
642150|NCT02284386|Primary|The Apparent Terminal Elimination Rate Constant (λz)||Baseline through Day 14|||1/hours||Standard Deviation|Mean
642151|NCT02284386|Primary|Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity After Drug Administration (AUC0-∞)||Baseline through Day 14|||hours x ng/mL||Standard Deviation|Mean
642152|NCT02284386|Primary|Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Last Collection Time After Drug Administration (AUC0-last)||Baseline through Day 14|||hours x ng/mL||Standard Deviation|Mean
642153|NCT02284386|Primary|Time to Peak Plasma Concentration (Tmax)||Baseline through Day 14|||hours||Full Range|Median
642154|NCT02284386|Primary|Maximum Plasma Concentration (Cmax)||Baseline through Day 14|Of 15 subjects, one subject was removed as an outlier||ng/mL||Standard Deviation|Mean
642155|NCT02284347|Secondary|Device Safety Profile as Measured by the Overall Adverse Event Rate|Overall adverse event rate|2 weeks|||Percentage of participants with an AE|||Number
642156|NCT02284347|Primary|Device-related Adverse Event Point Estimate|The primary safety endpoint was the point estimate (and confidence interval) for all AEs that were directly attributable to the device or for which the cause could not be determined and that met the definition of designated primary safety endpoint AEs as defined in the protocol.|2 weeks|Participants||Adverse Events||95% Confidence Interval|Number
642157|NCT02284347|Primary|Navigation to the Desired Sinus Treatment Location and Dilation of the Ostium|Two-fold endpoint: Investigator-assessment regarding the number of sinuses that were easily navigated to the desired treatment location and easy dilation of the ostium|At time of surgery|All patients that completed the study||Number of sinuses|||Number
642158|NCT02284243|Secondary|Number of Subjects With Complete Protection From PONV||24 hours|mITT population, including all randomized subjects who received at least one study dose||participants|||Number
642159|NCT02284243|Secondary|Time to First Rescue Medication Use|Kaplan Meier analysis of time to first use of rescue analgesia 50th percentile of subjects. Rescue analgesia (oral oxycodone) was available to subjects with inadequately controlled pain. All doses of rescue analgesia administered were recorded and the time from the first study dose to first rescue analgesia in each subject was evaluated. A longer time to first rescue is better.|48 hours|mITT population, including all randomized subjects who received at least one study dose||hours||95% Confidence Interval|Median
642160|NCT02284243|Secondary|Use of Rescue Medication (Oral Opioids)|Number of subjects requiring rescue medication (Oral opioids) within 48 hours after first study dose|48 hours|mITT population, including all randomized subjects who received at least one study dose||participants|||Number
642161|NCT02284243|Secondary|Number of Subjects With Significant Pain Improvement Following the First Study Dose.||6 hours|mITT population, including all randomized subjects who received at least one study dose||participants|||Number
642175|NCT02283827|Secondary|Tmax - the Time of Occurrence of Cmax|BIA 2-194 and BIA 2-195 are metabolites of eslicarbazepine acetate|Day 8 and 27: within 5 minutes prior to dosing and 0.5,1,1.5,2,2.5,3,3.5,4,6,9,12,16 and 24 hours after drug administration|||hours||Standard Deviation|Median
642209|NCT02282982|Secondary|Median Length of Stay (LOS) of Participants in the Intensive Care Unit (ICU)|The median length of stay of hospitalized participants in the Intensive Care Unit was calculated.|Approximately 7 months|Participants who were hospitalized due to Lower Respiratory Tract Infection and who had a positive Respiratory Syncytial Virus laboratory diagnostic test||days||Full Range|Median
642162|NCT02284243|Secondary|Time to Perceptible and Meaningful Pain Relief|Kaplan-Meier analysis of time to perceptible and meaningful pain relief for 50th percentile of subjects. Time to perceptible pain relief and time to meaningful pain relief were measured using the double-stopwatch method. The first stopwatch was given to each subject with the instructions to stop the watch when they first perceive pain relief to occur (time to perceptible relief). Once the first watch was stopped, the second stopwatch was given to the subject with the instructions to stop the watch when they are first experiencing meaningful pain relief (time to meaningful relief). A shorter time to pain relief is better.|6 hours|mITT population, including all randomized subjects who received at least one study dose||minutes||95% Confidence Interval|Median
642163|NCT02284243|Secondary|SPID at Various Other Time Points|Pain intensity was recorded using a Numeric Pain Rating Scale (Range 0-10) where 0 equates to no pain (better), and 10 equates to the worst pain imaginable (worse). Pain intensity scores were to be recorded at the following time points: 0.25, 0.5, 0.75, 1, 2, 4, and 6 hours post Dose 1. Thereafter pain assessments were to be recorded every 2 hours until 48 hours post Dose 1. Pain intensity differences from baseline were calculated at each time point and a time weighted summed pain intensity difference (SPID) was then calculated. Time weighted SPID calculations were computed by multiplying a weight factor to each score prior to summation. The weight factor at each time point was the time elapsed since the previous observation.|Up to 48 Hours|mITT population, including all randomized subjects who received at least one study dose||units on a scale||Standard Deviation|Mean
642164|NCT02284243|Primary|Summed Pain Intensity Difference Over the First 48 Hours (SPID48).|Pain intensity was recorded using a Numeric Pain Rating Scale (Range 0-10) where 0 equates to no pain (better), and 10 equates to the worst pain imaginable (worse). Pain intensity scores were to be recorded at the following time points: 0.25, 0.5, 0.75, 1, 2, 4, and 6 hours post Dose 1. Thereafter pain assessments were to be recorded every 2 hours until 48 hours post Dose 1. Pain intensity differences from baseline were calculated at each time point and a time weighted summed pain intensity difference (SPID) was then calculated. Time weighted SPID calculations were computed by multiplying a weight factor to each score prior to summation. The weight factor at each time point was the time elapsed since the previous observation.|48 hours|mITT population, including all randomized subjects who received at least one study dose||units on a scale||Standard Deviation|Mean
642165|NCT02284165|Secondary|Number of Participants Who Died Within 12 Months of Stroke Hospitalization|Death within 12 months of discharge from index stroke hospitalization as indicated in Medicare claims files|12 months post-discharge|Acute ischemic stroke patients in the Get With the Guidelines registry with Medicare fee-for-service health insurance, discharged to inpatient rehabilitation or skilled nursing facility and without survival limitations identified in-hospital. 69,212 patients met these criteria.||participants|||Number
642166|NCT02284165|Secondary|Number of Participants Who Were Rehospitalized or Died Within 12 Months of Stroke Hospitalization.|All-cause rehospitalization or death within 12 months of index stroke hospitalization as indicated in Medicare claims files.|12 months post-discharge|Acute ischemic stroke patients in the Get With the Guidelines registry with Medicare fee-for-service health insurance, discharged to inpatient rehabilitation or skilled nursing facility and without survival limitations identified in-hospital. 69,212 patients met these criteria.||participants|||Number
642167|NCT02284165|Secondary|Number of Participants Who Were Institutionalized in a Nursing Home for Long-term Care Within 12 Months of Hospital Discharge.|Institutionalization (primary living location in a nursing home for long-term care and not for rehabilitation or short-term skilled stay) as measured by patient or proxy family member report on 12-month follow-up phone call.|12 months post-discharge|Acute ischemic stroke patients in the Get With the Guidelines registry discharged to inpatient rehabilitation or skilled nursing facility, without survival limitations identified in-hospital and with 12-month follow-up as part of the Adherence Evaluation After Ischemic Stroke Longitudinal (AVAIL) registry. 473 patients met these criteria.||participants|||Number
642168|NCT02284165|Secondary|Quality of Life (QOL)|EuroQOL-5 Dimensions (EQ-5D) to assess health-related quality of life by asking and scoring the level of severity (1 = no problems, 2 = some problems, 3 = extreme problems) in 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Score for each question is added together to provide total score, which is converted to provide a range from 1 (maximum and highest health state for quality of life) down to 0 (lowest health state and quality of life).|12 months post-discharge|Acute ischemic stroke patients in the Get With the Guidelines registry discharged to inpatient rehabilitation or skilled nursing facility, without survival limitations identified in-hospital and with 12-month follow-up as part of the Adherence Evaluation After Ischemic Stroke Longitudinal (AVAIL) registry. 323 patients met these criteria.||units on a scale||Inter-Quartile Range|Median
642169|NCT02284165|Secondary|Number of Participants Who Were Functionally Dependent or Dead 12 Months After Hospital Discharge|12-month functional status as measured by modified Rankin scale scores ranging between 0 (no symptoms) and 6 (death), among patients discharged to inpatient rehabilitation or skilled nursing facility. Outcome measure reports number of participants with Rankin score of 3-6. The outcome was not assessed among patients discharged home.|12 months post-discharge|Acute ischemic stroke patients in the Get With the Guidelines registry discharged to inpatient rehabilitation or skilled nursing facility, without survival limitations identified in-hospital and with 12-month follow-up as part of the Adherence Evaluation After Ischemic Stroke Longitudinal (AVAIL) registry. 473 participants met these criteria.||participants|||Number
642170|NCT02284165|Primary|Home-time|Number of days alive and living outside of inpatient care|12 months post-discharge|Acute ischemic stroke patients in the Get With the Guidelines registry with Medicare fee-for-service health insurance, discharged to inpatient rehab or skilled nursing care and without survival limitations identified in-hospital. 69,212 patients met these criteria.||days||Standard Deviation|Mean
642171|NCT02284165|Primary|Number of Participants Receiving Inpatient, Home, or Community Based Rehabilitation Services|Received either inpatient care in an inpatient rehabilitation or skilled nursing facility, or home or community-based rehabilitation.|discharge through 90 days|Acute ischemic stroke patients in the Get With the Guidelines registry with Medicare fee-for-service health insurance, analyzed as one cohort rather than by arm to differentiate the different types of rehabilitation services within the full patient population.||participants|||Number
642172|NCT02283840|Primary|Tmax BIA 2-005 - Time of Maximum Plasma Concentration of BIA 2-005||prior to and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 24, 48 and 72 hours after drug administration|||hours||Standard Deviation|Median
642176|NCT02283827|Secondary|AUC0-t - the Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time|"AUC0-t - the Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time
BIA 2-194 and BIA 2-195 are metabolites of eslicarbazepine acetate"|Day 8 and 27: within 5 minutes prior to dosing and 0.5,1,1.5,2,2.5,3,3.5,4,6,9,12,16 and 24 hours after drug administration|||ng*h/mL||Standard Deviation|Mean
642177|NCT02283827|Primary|Cmax - the Maximum Plasma Concentration|BIA 2-194 and BIA 2-195 are metabolites of eslicarbazepine acetate|Day 8 and 27: within 5 minutes prior to dosing and 0.5,1,1.5,2,2.5,3,3.5,4,6,9,12,16 and 24 hours after drug administration|||ng/mL||Standard Deviation|Mean
642178|NCT02283814|Secondary|AUCτ - Cumulative Area Under the Plasma Concentration Time Curve Over the Dosing Interval at Steady State.||Time Frame: Group A:Day 8 and 27: within 5 minutes prior to dosing and 0.5,1,1.5,2,2.5,3,3.5,4,6,9,12,16 and 24 hours after drug administration; Group B: Day 8 and 27 within 5 minutes prior dosing and 0.25,0.5,0.75,1,1.33,1.67,2,2.5,3,4,6,9,12,16 and 24h|||ng.h/mL||Standard Deviation|Mean
642179|NCT02283814|Primary|Tmax - the Time of Occurrence of Cmax|BIA 2-194 and BIA 2-195 are metabolites/active forms of eslicarbazepine acetate Both Groups A and B described in participant flow recieved BIA 2-093 and Topiramate. The results presented here are related with the different interventions in both groups|Time Frame: Group A:Day 8 and 27: within 5 minutes prior to dosing and 0.5,1,1.5,2,2.5,3,3.5,4,6,9,12,16 and 24 hours after drug administration; Group B: Day 8 and 27 within 5 minutes prior dosing and 0.25,0.5,0.75,1,1.33,1.67,2,2.5,3,4,6,9,12,16 and 24h|||hours||Standard Deviation|Mean
642180|NCT02283814|Primary|Cmax - the Maximum Plasma Concentration|BIA 2-194 and BIA 2-195 are metabolites/active forms of eslicarbazepine acetate|Time Frame: Group A:Day 8 and 27: within 5 minutes prior to dosing and 0.5,1,1.5,2,2.5,3,3.5,4,6,9,12,16 and 24 hours after drug administration; Group B: Day 8 and 27 within 5 minutes prior dosing and 0.25,0.5,0.75,1,1.33,1.67,2,2.5,3,4,6,9,12,16 and 24h|||ng/mL||Standard Deviation|Mean
642181|NCT02283788|Secondary|QTcF - QT Interval Corrected Using Fridericia’s Formula||-30 minutes (pre-dose) 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, and 23.5 hours post-dose||||||
642182|NCT02283788|Secondary|QTcB - QT Interval Corrected for Heart Rate Using Bazett’s Formula||-30 minutes (pre-dose) 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, and 23.5 hours post-dose||||||
642183|NCT02283788|Primary|QTcI - QT Interval Individually Corrected for Heart Rate - Day 5||-30 minutes (pre-dose) 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, and 23.5 hours post-dose|||msec||Standard Deviation|Mean
642207|NCT02282982|Secondary|Proportion of Participants Who Received Mechanical Ventilation While Hospitalized|The proportion of participants who received mechanical ventilation while hospitalized was documented.|Approximately 7 months|Participants who were hospitalized due to Lower Respiratory Tract Infection and who had a positive Respiratory Syncytial Virus laboratory diagnostic test||participants|||Number
642525|NCT02273115|Primary|Delivery Rate|The rate of women who deliver in less than or equal to 24 hours from Foley placement.|Within 24 hours|||Participants|||Count of Participants
642208|NCT02282982|Secondary|Proportion of Participants Who Received Supplemental Oxygen While Hospitalized|The proportion of participants who received supplemental oxygen while hospitalized was documented.|Approximately 7 months|Participants who were hospitalized due to Lower Respiratory Tract Infection and who had a positive Respiratory Syncytial Virus laboratory diagnostic test||participants|||Number
642202|NCT02282982|Secondary|Proportion of Participants With a Particular Co-morbidity|The proportion of participants with co-morbidities was documented. Co-morbidities were defined by the International Statistical Classification of Diseases 10 revision (ICD-10).|Approximately 7 months|Infants who received immunoprophylaxis during the RSV season||participants|||Number
642203|NCT02282982|Secondary|Median Duration of Oxygen Administration During Hospitalizations|The median duration of mechanical oxygen administration during hospitalizations was calculated.|Approximately 7 months|Participants who were hospitalized due to Lower Respiratory Tract Infection and who had a positive Respiratory Syncytial Virus laboratory diagnostic test||days||Full Range|Median
642204|NCT02282982|Secondary|Median Duration of Mechanical Ventilation Administration During Hospitalizations|The median duration of mechanical ventilation administration during hospitalizations was calculated.|Approximately 7 months|Participants who were hospitalized due to Lower Respiratory Tract Infection and who had a positive Respiratory Syncytial Virus laboratory diagnostic test||days||Full Range|Median
642205|NCT02282982|Secondary|Proportion of Participants With Co-morbidities During Hospitalizations|The proportion of participants with co-morbidities during hospitalizations was documented. Co-morbidities were defined by the International Statistical Classification of Diseases 10 revision (ICD-10).|Approximately 7 months|Participants who were hospitalized due to Lower Respiratory Tract Infection and who had a positive Respiratory Syncytial Virus laboratory diagnostic test||participants|||Number
642206|NCT02282982|Secondary|Proportion of Participants With Missed Doses of Palivizumab|The proportion of participants with missed or delayed doses of palivizumab was documented.|Approximately 7 months|Infants who received immunoprophylaxis during the RSV season||participants|||Number
642210|NCT02282982|Secondary|Proportion of Participants With Intensive Care Unit (ICU) Admission Among Hospitalized Participants|The number of hospitalized participants admitted to the Intensive Care Unit was documented.|Approximately 7 months|Participants who were hospitalized due to Lower Respiratory Tract Infection and who had a positive Respiratory Syncytial Virus laboratory diagnostic test||participants|||Number
642211|NCT02282982|Secondary|Median Length of Stay (LOS) of Lower Respiratory Tract Infection (LRTI) Hospitalization With a Positive Respiratory Syncytial Virus (RSV) Test|The duration of hospitalizations due to LRTI which were accompanied by a positive RSV diagnostic test was documented.|Approximately 7 months|Participants who were hospitalized due to Lower Respiratory Tract Infection and who had a positive Respiratory Syncytial Virus laboratory diagnostic test||days||Full Range|Median
642212|NCT02282982|Primary|Proportion of Infants Who Died From a Confirmed Respiratory Syncytial Virus (RSV) Infection|Deaths caused by RSV during the study were to be confirmed by autopsy or clinical history and positive virologic diagnostic tests.|Approximately 7 months|Infants who received immunoprophylaxis during the RSV season||participants|||Number
642213|NCT02282982|Primary|Proportion of Infants Hospitalized for Lower Respiratory Tract Infection (LRTI) With a Positive Respiratory Syncytial Virus (RSV) Diagnostic Test|Hospitalizations for LRTI with positive RSV diagnostic tests were documented at study visits.|Approximately 7 months|Infants who received immunoprophylaxis during the RSV season||participants|||Number
642214|NCT02282813|Secondary|Number of Participants in the Per Protocol Population With NormalSerum 25-hydroxyvitamin D at End of Treatment (EOT)|Number of Participants in the per protocol population with serum 25-hydroxyvitamin D >/= 30 ng/mL at End of Treatment (EOT)|up to 6 months|Per protocol||participants|||Number
642215|NCT02282813|Secondary|Number of Participants in the Intent to Treat Population With Normal Serum 25-hydroxyvitamin D at End of Treatment (EOT)|Number of Participants in the Intent to Treat Population with serum 25-hydroxyvitamin D >/= 30 ng/mL at End of Treatment (EOT)|up to 6 months|Intent to treat||participants|||Number
642216|NCT02282813|Secondary|Number of Participants in the Per Protocol Population With Mean Reduction in Plasma Intact Parathyroid Hormone (iPTH) of >/= 30% From Baseline Values at End of Treatment (EOT)|Number of subjects in the per protocol population with a mean reduction in plasma intact parathyroid hormone (iPTH) of >/= 30% from pretreatment baseline values at end of treatment (EOT), classified as responders|up to 6 months|Per protocol||participants|||Number
642217|NCT02282813|Primary|Number of Participants in the Intent to Treat Population With a Mean Reduction in Plasma Intact Parathyroid Hormone (iPTH) of >/= 30% From Baseline Values at End of Treatment (EOT)|Number of subjects in the intent to treat population with a mean reduction in plasma intact parathyroid hormone (iPTH) of >/= 30% from pretreatment baseline values at end of treatment (EOT), classified as responders|up to 6 months|Intent to treat||participants|||Number
642218|NCT02282631|Secondary|Number of Participants Who Met Physical Activity Guidelines|"Number of participants who met physical activity guidelines, i.e. at least 60 minutes of moderate-to-vigorous physical activity (MVPA) a day, measured by accelerometer (ActiGraph GT3X+); cut points of intensity by Evenson et al (2008) (sedentary <100 counts per minute (cpm); light >100cpm; moderate >=2296cpm; vigorous >=4012cmp), epoch 10 seconds. Valid wear was at least 6h/day on at least 3 days (weekdays or weekends).
NOTE: the above criterion of 10h/day for at least 5 days was changed before the start of the fieldwork, although not on this website. We found studies which suggested that wearing the accelerometer 6h/day on at least three days, with or without weekend days, were sufficient to assess overall levels of physical activity. Consistent with these findings, this new minimum wear criterion was adopted in the present study."|9 weeks|14 participants in the control school (2 dropouts after baseline) and 15 in the intervention school (0 dropouts). Participants wore the accelerometer twice in the study, for one week each time. N of valid recordings= N children who met the minimum wear target (6h/day on at least 3 days) overall; only valid recordings were used to assess overall PA||N children who met PA guidelines|N of valid recordings available overall||Number
642219|NCT02282631|Primary|Parental ATS Reports by SMS|"Number of parental ATS reports by SMS.
In this case, for comparability with data from paper reports, one SMS reports refers to a week in which at least one SMS report was received from the parent.
Parental SMS reports were only possible in those weeks when the child was not wearing the accelerometer. Parents who had chosen to report ATS by SMS were requested to report by paper on the weeks when the child wore the accelerometer (once at baseline, and once at post-baseline), and could report ATS by SMS in all other weeks."|8 weeks after baseline|- 'One SMS report' refers to a week in which at least one SMS report of ATS was received from the parent throughout the study. The above 'number of units analyzed' refers to the total number of weeks, for all participants, in which parents could have reported ATS throughout the study.||N weeks with at least one SMS reply|N weeks with at least one SMS reply||Number
642220|NCT02282631|Primary|Differences in MVPA During the Hour Before the Classes, Based on Child Report|differences in minutes of MVPA between ATS and non-ATS trips during the hour before the classes (7:56-8:55), based on child report (i.e. child reported whether trip was ATS or non-ATS)|9 weeks (one week at baseline plus eight weeks after baseline)|This outcome refers to trips to school reported, irrespective of the school where they were reported. There are no comparisons between control and intervention school due to the low number of non-active trips.||minutes of MVPA|trips to school|Standard Deviation|Mean
642221|NCT02282631|Primary|Differences in MVPA During the Times Reported by the Parent, Based on Child Report|differences in minutes of MVPA between ATS and non-ATS trips during the times reported by the parent as pertaining to the journey to school, based on child report (i.e. child reported whether trip was ATS or non-ATS)|9 weeks (one week at baseline plus eight weeks after baseline)|This outcome refers to trips to school reported, irrespective of the school where they were reported. There are no comparisons between control and intervention school due to the low number of non-active trips.||minutes of MVPA|trips to school|Standard Deviation|Mean
642222|NCT02282631|Primary|Differences in MVPA During the Hour Before the Classes, Based on Parental Report|differences in MVPA between ATS and non-ATS trips during the hour before the classes (7:56-8:55), based on parental report (i.e. parent reported whether trip was ATS or non-ATS)|9 weeks (one week at baseline plus eight weeks after baseline)|This outcome refers to trips to school reported, irrespective of the school where they were reported. There are no comparisons between control and intervention school due to the low number of non-active trips.||minutes of MVPA|trips to school|Standard Deviation|Mean
648268|NCT02107014|Primary|Change in IL-23 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].|||pg/mL||95% Confidence Interval|Median
642223|NCT02282631|Primary|Differences in MVPA During the Times Reported by the Parent, Based on Parental Report|differences in minutes of moderate-to-vigorous physical activity (MVPA) between ATS and non-ATS trips during the times reported by the parent as pertaining to the journey to school, based on parental report (i.e. parent reported whether the trip was ATS or non-ATS)|9 weeks (one week at baseline plus eight weeks after baseline)|"Trips to school reported, irrespective of the school where they were reported. No comparisons between control and intervention school due to the low number of non-active trips. Number of Participants Analyzed in the ATS Trips Arm is the total N of participants whose parents reported ATS and provided data for MVPA. Likewise for Non-ATS Trips."||minutes of MVPA|trips to school|Standard Deviation|Mean
642224|NCT02282631|Primary|Active Travel to School Based on Child Report|Percentage of active trips to school based on child report. This data is from all the trips reported by children, whether parental reports exist for the same day or not. For that reason, this differs from the number of trips reported in 'Agreement Between Parent and Child Reports' because in that case, both parent and child reports were required for the same day.|9 weeks (one week at baseline plus eight weeks after baseline)|Children in Year 5 (age 9-10); reports of ATS were collected from the parent and from the child at baseline (week 0) and weekly during the post-randomisation period (week 1 to 8); ATS trips=active trips to school. This data are only from child reports of ATS.||% ATS trips|N trips to school reported by child||Number
642225|NCT02282631|Primary|Active Travel to School Based on Parental Report|Active travel to school (ATS) refers to the behaviour of travelling to school by human-powered means as opposed to motorised transportation, for example by walking or cycling. This was based on parental ATS reports.|9 weeks (one week at baseline plus eight weeks after baseline)|Reports of ATS from parent and from child at baseline (week 0) and weekly during the post-randomisation period (week 1-8); ATS trips=active trips to school. This data is from all trips reported by the parent whether child ATS reports are available for the same days or not; this differs from N trips in 'Agreement Between Parent and Child Reports'||% ATS trips|total N trips to school (parent-reported||Number
642226|NCT02282631|Primary|Agreement Between Parent and Child Reports|"Inter-rater agreement between parent and child ATS* reports
*Active Travel to School"|9 weeks (one week at baseline plus eight weeks after baseline)|||Kappa score|N trips to school with both reports|95% Confidence Interval|Number
642227|NCT02282631|Primary|Child ATS Reports Returned|"Number of child ATS* reports returned to the researcher (myself) throughout the study. Child ATS reports were always on paper.
*Active Travel to School"|9 weeks (one week at baseline plus eight weeks after baseline)|N of child ATS reports (always on paper) - is the total number of child ATS reports that could have been returned to the researcher throughout the study||N child ATS reports returned|N of child ATS reports||Number
642228|NCT02282631|Primary|Parental ATS Paper Reports Returned|"N parental ATS* paper reports returned to researcher(me)
*Active Travel to School
Paper reports with at least 1 box had been ticked out of the five boxes on the form (there was 1 box for each day of the week).
ATS reports were collected weekly, i.e. on the baseline week and on each of the eight post-baseline weeks. Accelerometers were only used twice; once at baseline (1week) and once at post-baseline (1week).
Parental paper ATS reports were preferred by 6 families, but on the 2 accelerometer weeks all participants had to use a paper reports including usual SMS respondents. In contr. group: all used paper reports at baseline (1st accel. week) (n=14), 6 usual paper respondents at post-baseline (6x8 weeks = 48), 6 SMS respondents who had to paper-report on the 2nd accel.week (both dropouts were SMS respondents & left too early for a 2nd accel.), so total N possible paper reports 14 + 48 + 6=68. Int. school: 15 participants & 8 usual paper respondents, total=15 + (8 x 8) + 7=86"|9 weeks (one week at baseline plus eight weeks after baseline)|The above number of participants corresponds to all participants in each group. The overall N of units analysed takes into account that although only some participants (6 in CG; 8 in IG) had chosen to report ATS by paper reports at baseline, everybody was expected to report by ATS paper report on the two weeks where the accelerometer was worn.||N of parental ATS paper reports returned|N of parental ATS paper reports||Number
642229|NCT02282631|Primary|Accelerometers Lost or Damaged|Number of accelerometers lost or damaged in this study|9 weeks (one week at baseline plus eight weeks after baseline)|||N of accelerometers lost or damaged|Total N times accelerometer was worn||Number
642230|NCT02282631|Primary|Number of Participants Who Returned Their Accelerometers on Time at the End of the Post-baseline Week|Number of participants who returned their accelerometer on time to the researcher (myself) on the designated day, at end of post-baseline week. This was the second week of wear for participants. Whereas all participants were assessed concurrently at baseline, different subsamples were assessed every week at post-baseline.|8 weeks after baseline|Participants who stayed long enough in the study to wear the accelerometer a second time, at post-baseline||Participants|||Count of Participants
642231|NCT02282631|Primary|Number of Participants Who Returned Their Accelerometers on Time at the End of the Baseline Week|Number of participants who returned their accelerometer to the researcher on the designated day, at end of baseline week (all children wore the accelerometer at the same time)|1 week|||Participants|||Count of Participants
642232|NCT02282631|Primary|Retention of Participants|Number of participants who remained in the study until the end.|September 2014 to December 2014|There were 14 participants in the control school, and 15 participants in the intervention school, at baseline. In the post-baseline weeks, there were two dropouts in the control school, and none in the intervention school.||N children retained for the whole study|||Number
642233|NCT02282631|Primary|Recruitment of Participants|Number of participants recruited in this study.|Sep 2014 to December 2014|Number of participants approached to take part in the study||N of children who took part in the study|||Number
642234|NCT02282631|Primary|School Retention|% of schools who were retained for the whole duration of the study (out of the two who took part)|September 2014 to December 2014|||% schools retained for the whole study|||Number
642235|NCT02282631|Primary|Schools Who Accepted to Take Part|Percentage of schools who accepted to take part in this study|May 2014 to June 2014|123 schools were approached; 4 accepted to take part but only 2 were selected to take part||% schools who accepted to take part|||Number
642236|NCT02282605|Secondary|The Number of Participants With Changes in Vital Signs, ECG and Routine Haematology, Clinical Chemistry and Urinalysis Tests.||Assessed over the two day treatment period and follow-up at 7 and 14 days relative to the first dose.|||participants|||Number
643625|NCT02231918|Secondary|Vital Signs (Pulse Rate)|Vital signs (Pulse rate (both supine and after standing for 1 minute)).|-0:15h(hours) pre-dose, and 0:30h, 1:00h, 2:00h, 3:00h, 5:00h, 7:00h, 12:00h, 24:00h|Safety analysis set||bpm||Standard Deviation|Mean
642237|NCT02282605|Secondary|AUC of the Semi-quantitative SA Scores From Nasal Swabs|Anti-SA activity was assessed by the quantification of SA colonisation using the broth enriched (semi-quantitative culture) 0-6 point scale. Mean changes from baseline (0h) to each timepoint (Day 1,12 h; Day 2, 24 h: Day 3, 48h; Day 4, 84h; Day 7, 144h; Day 14, 312h) were calculated by treatment for the semi-quantitative SA scores. The AUC of the semi-quantitative SA scores were calculated for the two-day treatment period (AUC Day1- Day2); through the two day treatment period and up to discharge (AUC Day 1- Day4); and over the two-day treatment period, discharge and follow-up (AUC Day1- Day14). AUC was calculated by means of a trapezoidal rule using a standard algorithm. A higher AUC is indicative of a higher bacterial growth.|2 day treatment period; 2 day treatment period up to discharge; 2 day treatment period, discharge and follow-up|A comparison between treatment groups was performed separately for each AUC with an ANCOVA model with AUC as dependent variable, treatment as fixed effect and baseline SA (0 hours) as covariate. The AUC is a cumulative measure, comparison could be performed only within the same time period therefore data was normalised over time.||units on a scale||Standard Deviation|Mean
642238|NCT02282605|Secondary|Time-point at Which Clearance Was First Observed From Nasal Swabs Based on Semi-quantitative Score|The number of subjects with absence of SA from nasal swabs at the specified time-points..|Day 1 (12 h), Day 2 (24 h) , Day 3 (12 hours after last dose),Day 4 (48 hours after last dose)|||participants|||Number
642239|NCT02282605|Secondary|Apparent Eradication of Nasal SA After the Last Dose of XF-73 Based on Semi-quantitative SA Scores From a Broth Enrichment Method.|Anti-SA activity was assessed by the quantification of SA colonisation using the broth enriched (semi-quantitative culture) 0-6 point scale. Scores of negative and 0 were interpreted as absence of SA (Responder) and scores of 1 or greater were interpreted as presence of SA (Non-Responder).|Time-points: Day 1(12 hours), Day 2 (24 hours), Day 3 (12 hours after last dose), Day 7 and Day 14.|Exploratory comparisons between active groups versus placebo of the percentage of Responder subjects were performed using a one-sided Fisher's exact test at 5% significance level.||participants|||Number
642240|NCT02282605|Primary|Apparent Eradication of Nasal SA After the Last Dose of XF-73 Based on Semi-quantitative SA Scores From a Broth Enrichment Method.|Anti-SA activity was assessed by the quantification of SA colonisation using the broth enriched (semi-quantitative culture) 0-6 point scale. Scores of negative and 0 were interpreted as absence of SA (Responder) and scores of 1 or greater were interpreted as presence of SA (Non-Responder).|The primary endpoint was 48 hours after the last dose (Day 4, 84 hours).|Exploratory comparisons between active groups versus placebo of the number of Responder subjects were performed using a one-sided Fisher's exact test at 5% significance level.||participants|||Number
642241|NCT02282527|Secondary|Number of Subjects With Immunogenicity Response|Blood samples for immunogenicity testing were collected at Weeks 1 (Baseline), 9, 17, and 20. Any samples that tested positive for alpha₁-PI antibodies were tested for neutralizing antibodies and antibody titer. Immunogenicity testing was performed using validated assays in a multitiered approach. Samples collected at Week 1 (Baseline) and at Weeks 9 and 20 were tested for immunogenicity while samples collected at Week 17 were to be tested for immunogenicity only if deemed appropriate (eg, unexpected PK profile).|Weeks 1, 9, 17, and 20|||Participants|||Count of Participants
642242|NCT02282527|Secondary|AUC(0-7 Days) Based on Functional Activity|The exploratory PK objective of this study was to demonstrate the bioequivalence of Liquid Alpha₁-PI 60 mg/kg to Prolastin-C 60 mg/kg, as measured by AUC from 0 to 7 days (AUC 0-7 days) using a functional activity assay of alpha₁-PI, at approximate steady state in subjects with AATD.|pre-dose, 0, 15 min, 30 min, 1 hour, 2 hours, 4 hours, 8 hours, 1 day, 2 days, 5 days, 7 days post dose|||mg*h/mL||Standard Deviation|Mean
642243|NCT02282527|Primary|AUC(0-7 Days) Based on Antigenic Content|The primary PK objective of this study was to demonstrate the bioequivalence of Liquid Alpha₁-PI 60 mg/kg to Prolastin-C 60 mg/kg, as measured by AUC from 0 to 7 days (AUC0-7days) using an antigenic content assay of alpha₁-PI, at approximate steady state in subjects with AATD.|pre-dose, 0, 15 min, 30 min, 1 hour, 2 hours, 4 hours, 8 hours, 1 day, 2 days, 5 days, 7 days post dose|||mg*h/mL||Standard Deviation|Mean
642244|NCT02281591|Secondary|AUC0-t - the Area Under the Plasma Concentration-time Curve to Last Measurable Time Point||Phase A: pre-dose (Day 1); and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.Phase B: Days 6 to 10 inclusively: pre-dose. Day 11 (last dose): pre-dose; and ½, 1, 1½,2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.|||ng.h/mL||Standard Deviation|Mean
642245|NCT02281591|Primary|AUC0-∞ - the Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity||Phase A: pre-dose (Day 1); and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.Phase B: Days 6 to 10 inclusively: pre-dose. Day 11 (last dose): pre-dose; and ½, 1, 1½,2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.|||ng.h/mL||Standard Deviation|Mean
642246|NCT02281591|Primary|Tmax - the Time of Occurrence of Cmax||Phase A: pre-dose (Day 1); and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.Phase B: Days 6 to 10 inclusively: pre-dose. Day 11 (last dose): pre-dose; and ½, 1, 1½,2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.|||hours||Standard Deviation|Mean
642247|NCT02281591|Primary|Cmax - the Maximum Plasma Concentration||Phase A: pre-dose (Day 1); and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.Phase B: Days 6 to 10 inclusively: pre-dose. Day 11 (last dose): pre-dose; and ½, 1, 1½,2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.|||ng/mL||Standard Deviation|Mean
642248|NCT02281526|Secondary|Cmax - Peak Plasma Concentration|Day 1 - Cmax Peak plasma concentration|pre-dose and 1, 2, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 4.25, 4.5, 4.75, 5, 7, 9, 12 and 24 hours post-dose.|||ng/mL||Standard Deviation|Mean
642249|NCT02281526|Primary|Area Under the Plasma Concentration Versus Time Curve, AUC(0-tlast).|"Day 1 - Area under the plasma concentration versus time curve, AUC(0-tlast).
BIA 2-194, 2-195 Glucoronide, Oxcarbazepine, BIA 2-093 Glucoronide, 2-194 Glucoronide are BIA 2-093 metabolites."|pre-dose and 1, 2, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 4.25, 4.5, 4.75, 5, 7, 9, 12 and 24 hours post-dose.|||h·ng/mL||Standard Deviation|Mean
642250|NCT02281448|Secondary|AUC0-t|AUC0-t (ng.h/mL) following administration of a single-dose of Microginon® concomitantly with the 14th dose of a 15-day oral regimen of BIA 2-093 1200 mg once-daily (Test) and following administration of a single-dose of Microginon® administered alone (Reference)|pre-dose, on Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 of the BIA 2-093 + OC period.|||pg.h/mL||Standard Deviation|Mean
643870|NCT02226198|Secondary|Abnormal Vital Signs|Safety and tolerability will be described in terms of abnormal vital signs|From screening (5-6weeks before dose) up to the last visit Day 168 (approximately 30 weeks after screening)|||participants|||Number
642251|NCT02281448|Secondary|Tmax|Tmax following administration of a single-dose of Microginon® concomitantly with the 14th dose of a 15-day oral regimen of BIA 2-093 1200 mg once-daily (Test) and following administration of a single-dose of Microginon® administered alone (Reference)|pre-dose, on Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 of the BIA 2-093 + OC period.|||h||Standard Deviation|Mean
642252|NCT02281448|Secondary|Cmax|Cmax following administration of a single-dose of Microginon® concomitantly with the 14th dose of a 15-day oral regimen of BIA 2-093 1200 mg once-daily (Test) and following administration of a single-dose of Microginon® administered alone (Reference)|pre-dose, on Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 of the BIA 2-093 + OC period.|||pg/mL||Standard Deviation|Mean
642253|NCT02281448|Primary|Cmax - Maximum Observed Plasma BIA 2-194 Concentration|Cmax - Maximum observed plasma BIA 2-194 concentration on days 1, 2, 4, 6, 8, 10, 12, 14 and 15 during a 15-day oral regimen of BIA 2-093 1200 mg once-daily.|Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 during a 15-day oral regimen of BIA 2-093 1200 mg once-daily.|||ng/mL||Standard Deviation|Mean
642254|NCT02281422|Primary|AUC(0-12h) - AUC From Time Zero to 12h|"BIA 2-194; BIA 2-195; Oxcarbazepine are BIA 2-093 metabolites
AUC - area under the plasma concentration versus time curve"|pre-dose and 1, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 5, 7, 9, 12, 24, 48, 72 and 96 hours post-dose.|||ng*h/mL||Standard Deviation|Mean
642255|NCT02281422|Secondary|Tmax (hr) - Time at Which Cmax Occurred|"BIA 2-194; BIA 2-195; Oxcarbazepine are BIA 2-093 metabolites
Cmax - maximum observed plasma drug concentration"|pre-dose and 1, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 5, 7, 9, 12, 24, 48, 72 and 96 hours post-dose.|||hours||Standard Deviation|Mean
642256|NCT02281422|Primary|Cmax - Peak Plasma Concentration|BIA 2-194; BIA 2-195; Oxcarbazepine are BIA 2-093 metabolites|pre-dose and 1, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 5, 7, 9, 12, 24, 48, 72 and 96 hours post-dose.|||ng/mL||Standard Deviation|Mean
642257|NCT02281318|Secondary|Mean Change From Baseline in Asthma Control Questionnaire (ACQ-5) Score at Week 24|The ACQ-5 is a five-item questionnaire, designed to be self-completed by the participants. ACQ-5 score is the mean score of 5 questions, each assessed on a 0-6 point scale to give a mean ranging between 0-6 with lower scores indicating better outcome. The five questions inquired about the frequency and/or severity of symptoms over the previous week. The response options for all these questions consisted of a zero (no impairment/limitation) to six (total impairment/limitation) scale. The mean change from Baseline was calculated as the value at Week 24 minus the Baseline value for each participant and analyzed using a mixed model repeated measures allowing for covariates of Baseline value, region, Baseline maintenance OCS therapy, exacerbations in the year prior to the study (as an ordinal variable), Baseline % predicted FEV1 and visit, plus interaction terms for visit by Baseline and visit by treatment group.|Baseline and Week 24|mITT Population. Participants with a missing Baseline covariate value or with no observed change from Baseline at any time point were excluded from the analysis model.||Scores on a scale||Standard Error|Least Squares Mean
642258|NCT02281318|Secondary|Percentage of Participants Achieving a 4 Point or Greater Reduction From Baseline in SGRQ Score at Week 24|The percentage of participants achieving a 4 point or greater reduction from Baseline in SGRQ (scored from 0-100 with lower scores indicating better outcome) at Week 24 was compared between treatment groups using a logistic regression model with covariates of Baseline value, region, Baseline maintenance OCS therapy, exacerbations in the year prior to the study (as an ordinal variable) and Baseline % predicted FEV1.|Baseline (Visit 2-latest pre-dose assessment) and Week 24|mITT Population. Participants with a missing Baseline covariate value were excluded from the analysis model.||Percentage of participants|||Number
642259|NCT02281318|Secondary|Mean Change From Baseline in Clinic Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Week 24|FEV1 is the volume of air that can be forced out in one second after taking a deep breath. The change from Baseline in pre-bronchodilator FEV1 was calculated as the value at Week 24 minus the value at Baseline for each subject and was analyzed using a mixed model repeated measures adjusting for Baseline absolute pre-bronchodilator FEV1, region, Baseline maintenance OCS therapy, exacerbations in the year prior to the study and visit, plus interaction terms for visit by Baseline and visit by treatment group.|Baseline and Week 24|mITT Population. Participants with a missing Baseline covariate value or with no observed change from Baseline at any time point were excluded from the analysis model.||Milliliters (mL)||Standard Error|Least Squares Mean
642260|NCT02281318|Primary|Mean Change From Baseline (BL) in St. George’s Respiratory Questionnaire (SGRQ) Score at Week 24|SGRQ consisted of 50 questions (scored from 0 to 100 where 0 indicates best and 100 indicates worst health) designed to measure Quality of Life in par. with diseases of airway obstruction, measuring symptoms, impact, and activity. Questions were completed by the par. with a recall over the past 4 weeks. SGRQ Total Score was calculated by summing the pre-assigned weights of answers, dividing by the sum of the maximum weights for items in SGRQ and multiplying by 100 to get a %. Change from BL in SGRQ was calculated as value at Week 24 minus value at BL for each par. and was analyzed using mixed model repeated measures allowing for covariates of BL value, region, BL maintenance oral corticosteroid (OCS) therapy, exacerbations in the year prior to the study (as an ordinal variable), BL % predicted FEV1 and visit, plus interaction terms for visit by BL and visit by treatment group. Modified Intent-to-Treat (mITT) Population consisted of all randomized par. who received >= 1 dose of drug.|Baseline and Week 24|mITT Population. Participants with a missing Baseline covariate value or with no observed change from Baseline at any time point were excluded from the analysis model.||Scores on a scale||Standard Error|Least Squares Mean
642261|NCT02281136|Secondary|OOZING/VESICULATION/CRUSTING|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|Week 4|||participants|||Number
642262|NCT02281136|Secondary|OOZING/VESICULATION/CRUSTING|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|24 hours after PDT #1|One subject did not have assessment performed||participants|||Number
642263|NCT02281136|Secondary|OOZING/VESICULATION/CRUSTING|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|Baseline|||participants|||Number
642264|NCT02281136|Secondary|Scaling and Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Week 4|||participants|||Number
642265|NCT02281136|Secondary|Scaling and Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|24 hours after PDT #1|One subject did not have assessment performed||participants|||Number
642266|NCT02281136|Secondary|Scaling and Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Baseline|||participants|||Number
642267|NCT02281136|Secondary|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|Week 4|||participants|||Number
642268|NCT02281136|Secondary|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|24 hours after PDT #1|One subject did not have assessment performed||participants|||Number
642269|NCT02281136|Secondary|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|5 Minutes after PDT|||participants|||Number
642270|NCT02281136|Secondary|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|During PDT|||participants|||Number
642271|NCT02281136|Secondary|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|Baseline|||participants|||Number
642272|NCT02281136|Secondary|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Week 4|||participants|||Number
642273|NCT02281136|Secondary|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|24 hours after PDT #1|One subject did not have assessment performed||participants|||Number
642274|NCT02281136|Secondary|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|5 Minutes after PDT|||participants|||Number
642275|NCT02281136|Secondary|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Baseline|||participants|||Number
642276|NCT02281136|Secondary|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Week 4|||participants|||Number
642277|NCT02281136|Secondary|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|24 hours after PDT #1|One subject did not have assessment performed||participants|||Number
642278|NCT02281136|Secondary|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|5 Minutes after PDT|||participants|||Number
642279|NCT02281136|Secondary|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Baseline|||participants|||Number
642280|NCT02281136|Secondary|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|Week 4|||participants|||Number
642281|NCT02281136|Secondary|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|24 hours post PDT#1|One subject did not have assessment performed||participants|||Number
642282|NCT02281136|Secondary|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|Baseline|||participants|||Number
642283|NCT02281136|Secondary|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Week 4|||participants|||Number
642284|NCT02281136|Secondary|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|24 hours after PDT|One subject did not have assessment performed||participants|||Number
642285|NCT02281136|Secondary|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Baseline|||participants|||Number
642286|NCT02281136|Primary|The Terminal Exponential Half-life (T1/2,z)|The terminal slope will be calculated by linear least squares regression of the log plasma concentration-time data. The terminal exponential half-life (T1/2,z) will be calculated as 0.693 divided by the absolute value of slope.|1 day|T1/2,z could not be determined in 4 subjects||hours||Geometric Coefficient of Variation|Geometric Mean
642287|NCT02281136|Primary|AUCt|AUCt is the area under the baseline corrected plasma concentration-time profile up to the last quantifiable/non-negative plasma concentration|0, 15, 30 minutes, and 1, 2, 4, 8, 12, 16, 24 hours post-dose|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
642288|NCT02281136|Primary|Time at Which Cmax is Attained (Tmax) for ALA|Time of the maximum baseline corrected plasma concentration for ALA measured at at 15 and 30 minutes, 1, 2, 4, 8, 12, 16 and 24 hours following study medication application.If a maximum value occurred at more than one timepoint Tmax is defined as the first timepoint with this value.|1 day|||hours||Full Range|Median
642289|NCT02281136|Primary|Maximum Baseline Corrected Plasma Concentration (Cmax) for ALA|Maximum baseline corrected plasma concentration (Cmax) for ALA over the 24 hour sampling time period. Blood samples wiere taken before ALA application and at 15 and 30 minutes, 1, 2, 4, 8, 12, 16 and 24 hours following study medication application.|1 day|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
642290|NCT02280811|Secondary|Expression of Programmed Cell Death 1 (PD-1) by Circulating E6 T-Cell Receptor (TCR) T-Cells|Presence of PD-1 on circulating lymphocytes by flow cytometry one month after treatment.|one month after treatment|One patient in group HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2 did not have research blood collected at one month post infusion, and thus could not examine the cells for that patient at that time point.||% PD-1 circulating lymphocytes||Full Range|Mean
642291|NCT02280811|Secondary|Percentage of Cluster of Differentiation 3 (CD3+) Cells That Are E6 T-Cell Receptor Memory of Circulating T-Cells in Responders and Non-responders|Detection of E6 TCR T cells in patients peripheral blood leukocytes (PBL)/apheresis samples by flow cytometry.|One month after treatment|One patient in group HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2 did not have research blood collected at one month post infusion, and thus could not examine the cells for that patient at that time point.||percentage of cells||95% Confidence Interval|Mean
642292|NCT02280811|Secondary|Number of Participants With a Dose Limiting Toxicity (DLT)|A dose limiting toxicity is all Grade 3 and greater toxicities with the exception of myelosuppression, defined as lymphopenia, neutropenia, decreased hemoglobin, and thrombocytopenia, due to chemotherapy preparative regimen. Aldesleukin expected toxicities as defined in Appendix 2 and 3 of the protocol. Expected chemotherapy toxicities as defined in the pharmaceutical information section. Immediate hypersensitivity reactions (excluding symptomatic bronchospasm and grade 4 hypotension) occurring within 2 hours of cell infusion (related to cell infusion) that are reversible to a grade 2 or less within 24 hours of cell administration with standard therapy. Grade 3 fever. Events that are clearly related to the patient's disease.|19 months and 7 days|||Participants|||Count of Participants
642323|NCT02279667|Primary|Tmax - the Time of Occurrence of Cmax|Tmax - the Time of Occurrence of maximum plasma concentration of BIA 2-093 metabolite: BIA 2-005|Blood samples for PK assays: pre-dose, 30, 60 and 90 minutes, and 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose|||hours||Full Range|Median
642293|NCT02280811|Secondary|Number of Participants With Serious and Non-serious Adverse Events|Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|19 months and 7 days|||Participants|||Count of Participants
642294|NCT02280811|Primary|Duration of Response|Duration of response is measured from the time measurement criteria are met for complete response or partial response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progression is at least a 20% increase in the sum of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|up to one year|||months||95% Confidence Interval|Mean
642295|NCT02280811|Primary|Objective Tumor Response Rate (Complete or Partial Response)|Objective tumor response rate is defined as the number of participants with a complete or partial response per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|4 years|||participants|||Number
642296|NCT02280811|Primary|Maximum Tolerated Dose (MTD)|The MTD is the highest dose at which ≤1 of 6 patients experienced a dose limiting toxicity (DLT) or the highest dose level studied if DLTs are not observed at any of the dose levels.|participants were followed for the duration of hospital stay, an average of 3 weeks|||# of cells x 10^11|||Number
642297|NCT02280655|Primary|Brachial Artery Flow-mediated Dilation (FMD) After Fresh Red Blood Cells (RBCs) Transfusions vs. Storage-aged Red Blood Cells (saRBCs) Transfusions at 24 Hours After Transfusion|Ultrasonography of the brachial artery performed at the bedside using a high-resolution 10-megahertz (MHz) ultrasound transducer before and after suprasystolic inflation of a blood pressure cuff for 5 minutes in the ipsilateral upper arm. Brachial artery FMD was calculated as (hyperemic diameter −24 hour diameter)/24 hour diameter × 100.|24 hours after transfusion|||percentage of brachial artery diameter||Standard Deviation|Mean
642298|NCT02280655|Primary|Brachial Artery Flow-mediated Dilation (FMD) After Fresh Red Blood Cells (RBCs) Transfusions vs. Storage-aged Red Blood Cells (saRBCs) Transfusions at Baseline|Ultrasonography of the brachial artery performed at the bedside using a high-resolution 10-megahertz (MHz) ultrasound transducer before and after suprasystolic inflation of a blood pressure cuff for 5 minutes in the ipsilateral upper arm. Brachial artery FMD was calculated as (hyperemic diameter − baseline diameter)/baseline diameter × 100.|Baseline|||percentage of brachial artery diameter||Standard Deviation|Mean
642299|NCT02280499|Secondary|ASES Shoulder Score Index|The American Shoulder and Elbow Surgeon's (ASES) evaluation is used to document the improvement in pain, function and range of motion after shoulder injury. The ASES Shoulder Score Index is calculated from the ASES patient related questionnaire and ranges from 0-100 with a higher score indicating improvement in pain and function.|10Years|As per the study flow chart, 26 study participants had a 10 year follow-up visit to collect the data supporting the primary outcome measure. The ASES Shoulder Score Index was calculated for 27 participants. As the score is a patient reported outcome the score could be completed at home increasing the number of available scores.||units on a scale||Standard Deviation|Mean
642300|NCT02280499|Secondary|Constant Murley Score|The Constant Murley Score is a shoulder outcome score to determine the functionality of the shoulder after the treatment of a shoulder injury. The score ranges from 0 to 100 with a higher score indicating better shoulder function.|10 Years|As per the study flow chart, 26 study participants had a 10 year follow-up visit to collect the data supporting the primary outcome measure. The Constant Murley Score was incomplete for 3 participants and therefore the number of participants analyzed is 23.||units on a scale||Standard Deviation|Mean
642301|NCT02280499|Primary|Radiological and Clinical Loosening Rates of the Glenoid and Humeral Components|The long-term survival rate of the Promos™ Standard shoulder system was calculated with revision due to aseptic loosening as endpoint using a Kaplan-Meier Analysis.|up to 10 years|||Percentage survivorship||95% Confidence Interval|Number
642302|NCT02280473|Secondary|Change From Baseline in the Schirmer Test|The Schirmer's Test measures the rate of the secretion of tears produced by the eye over 5 minutes. The results indicate the presence of dry eye. The eye with the lower value at Baseline was used for Analysis. Normal = greater than or equal to 15 millimeters (mm) of tears, Dry Eye = less than 15 mm of tears.. The smaller the number, the more severe the dry eye. A positive number change from Baseline indicates improvement. The eye with the lower value at baseline is used for each subject.|Baseline, Day 30|Intent-to-Treat: All randomized patients||mm/5 min||Standard Deviation|Mean
642303|NCT02280473|Secondary|Change From Baseline in the Combined Corneal and Conjunctival Staining Scores|The cornea is the transparent front part of the eye which covers the iris and pupil. The conjunctiva is the clear membrane covering the white surface of the eye. The cornea is divided into 5 zones and the nasal and temporal conjunctiva is divided into 6 zones. The combined staining score is based on the sum of the five zones on the cornea and the six zones on the conjunctiva. Each zone is graded on a 0-5 scale (0=None; 1=trace; 2=mild; 3=moderate; 4=severe; 5=very severe), for a total score ranging from 0-55. The higher the score, the worse the dry eye condition. A negative number change from baseline represents a decrease in the severity of staining (improvement). The eye with higher score at baseline is reported for each subject.|Baseline, Day 30|Intent-to-Treat: All randomized patients||Scores on a Scale||Standard Deviation|Mean
642304|NCT02280473|Secondary|Change From Baseline in Tear Break-up Time (TBUT)|TBUT is the time required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A short TBUT is a sign of poor tear film. A positive number change from baseline indicates an increase in TBUT (improvement). The eye with shorter average TBUT at baseline is reported for each patient.|Baseline, Day 30|Intent-to-Treat: All randomized patients||Seconds||Standard Deviation|Mean
642305|NCT02280473|Secondary|Change From Baseline in the OSDI© Score|The OSDI is a 12-question survey for patients to document their dry eye disease symptoms. The OSDI consists of a 5-point scale (0=none of the time and 4=all of the time), with higher scores representing greater disability. The scores are totaled over the 12 questions and converted to a score of 0-100 (0=no disability and 100=complete disability). A negative number change from baseline represents an improvement.|Baseline, Day 7|Intent-to-Treat: All randomized patients||Scores on a Scale||Standard Deviation|Mean
642306|NCT02280473|Primary|Change From Baseline in the Ocular Surface Disease Index© (OSDI©) Score|The OSDI is a 12-question survey for patients to document their dry eye disease symptoms. The OSDI consists of a 5-point scale (0=none of the time and 4=all of the time), with higher scores representing greater disability. The scores are totaled over the 12 questions and converted to a score of 0-100 (0=no disability and 100=complete disability). A negative number change from baseline represents an improvement.|Baseline, Day 30|Intent-to-Treat: All randomized patients||Scores on a Scale||Standard Deviation|Mean
642307|NCT02280187|Secondary|Fusion Rates in Subgroups|Fusion rates in subgroup (Smokers, non-smokers, Patients with and without diabetes) are reported.|12 months|||percentage of participants|||Number
642308|NCT02280187|Secondary|Fusion Status at the Last Assessment Performed by 12 Months|According to the study protocol, fusion status was determined to be either success or no success based on the images. If fusion failed at 1 level, the fusion was considered to be failed for the patient. The fusion rate at the last assessment is reported.|12 months|The subjects with the image that unable to determine fusion status and the assessment not done” were not taken into account.||percentage of participants|||Number
642309|NCT02280187|Secondary|The Number of Unplanned Secondary Spine Interventions in Subgroups|The number of unplanned secondary spine interventions is reported by subgroups (smoker, non-smoker, diabetics, and non-diabetics).|12 months|||participants|||Number
642310|NCT02280187|Secondary|The Number of Subjects Having Secondary Spine Surgical Intervention|The number of subjects who had secondary spine surgical intervention at index level treated with InductOs and other level (either never treated or treated without InductOs) through 12 months is reported.|12 months|||participants|||Number
642311|NCT02280187|Secondary|AEI Categorisation|The number of AEIs is presented by the categories predefined in the study protocol. The AEI MedDRA coded terms are presented in Section of serious adverse event.|12 months|||events|adverse event||Number
642312|NCT02280187|Secondary|The Number of Adverse Events of Interest|An adverse event was considered an event of interest (AEI) if an adverse event was considered important to follow. These included reactions described in the EU product label, events monitored in the EU Risk Management Plan, events that were considered possible related to the treatment by the investigator, and events that had serious health consequences for patients (e.g. hospitalization).|12 months|||events|||Number
642313|NCT02280187|Primary|Instrumentations Used for Stabilization|The number of spine levels using instrumentations for stabilization is presented by types of instrumentations.|during surgery|The total levels in the summary are higher than total amount of levels because multiple answers are possible.||spine level|Spine level||Number
642314|NCT02280187|Primary|Supplemental Fixation|The number of spine levels on which supplemental fixation was performed is presented by approaches of stabilization (anterior or posterior stabilization).|During surgery|The total levels across all the rows are higher than total number of levels analyzed because some levels may be represented in more than one rows.||spine level|Spine level||Number
642315|NCT02280187|Primary|Placement of the Matrix Wetted With InductOs|The placement of the matrix was classified as posterior lateral or interbody space (Inside the cage, between the cages or outside the cage) or any other placement specified. The number of spine levels is presented by placement of the matrix.|During surgery|The total levels across all the rows are higher than total number of levels analyzed because multiple answers are possible.||spine level|Spine level||Number
642316|NCT02280187|Primary|The Interbody Device Brand/Generic Names Used With InductOs|The number of spine levels with InductOs is presented by interbody brand/generic names.|during surgery|||spine level|Spine level||Number
642317|NCT02280187|Primary|Primary Surgical Approaches Used for Implantation of InductOs|The surgical approaches for implanting InductOs are classified as anterior lumbar interbody fusion (ALIF), posterior lumbar interbody fusion (PLIF), translateral lumbar interbody fusion (TLIF), lateral lumber interbody fusion (LLIF, including DLIF and XLIF), posterolateral fusion (PLF). The number of spine levels by surgical approaches is presented.|During surgery|||spine level|Spine level||Number
642318|NCT02280187|Primary|Spine Levels Treated|The number of spine levels from the occiput to S1 is presented.|During surgery|||spine level|Spine level||Number
642319|NCT02280187|Primary|The Primary Diagnostic Indication for InductOs Use|The primary diagnostic indications, which patients were treated with InductOs during spine fusion surgery in France, are presented.|Baseline|||percentage of participants|||Number
642320|NCT02280122|Primary|Percentage of True Positive/Negative aMMP-8 Tests of All Periodontitis Patients (Sensitivity/Specificity)|First off all patients rinsed with tap water for 30 seconds. Then they spat out the water and waited for 1 min. Now patients rinsed with 5ml of purified water for 30 seconds and spat this sample back into the test cup. Approximately 2 ml of the sampled saliva was now sampled with a syringe. After a filter was put onto the syringe 3 drops of the saliva were pressed through the filter into the ELISA kit. After 5 to 10 min the result was read from the test kit [21]. If both the control and test stripes were visible the respective test was positive (i.e. ≥ 25 ng aMMP 8 per ml). The clinical examiner (SIB) judged the results by simple visual inspection. Already a faint test stripe was judged as positive test. All test results were photographed with 2fold magnification. All images of the test were then evaluated by a second examiner (PE) who was blinded for the clinical diagnoses.|5 minutes|||percentage of true cases (sens./spec.)||95% Confidence Interval|Number
642321|NCT02279667|Primary|AUC0-∞ - the Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity|AUC0-∞ - the Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity of BIA 2-093 metabolite: BIA 2-005|Blood samples for PK assays: pre-dose, 30, 60 and 90 minutes, and 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose|||ng*h/mL||Standard Deviation|Mean
642322|NCT02279667|Primary|AUC0-t - the Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time|AUC0-t - the Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time of BIA 2-093 metabolite: BIA 2-005|Blood samples for PK assays: pre-dose, 30, 60 and 90 minutes, and 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose|||ng*h/mL||Standard Deviation|Mean
642324|NCT02279667|Primary|Cmax - the Maximum Plasma Concentration|Cmax - the maximum plasma concentration of BIA 2-093 metabolite: BIA 2-005|Blood samples for PK assays: pre-dose, 30, 60 and 90 minutes, and 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose|||ng/mL||Standard Deviation|Mean
642325|NCT02279420|Primary|Mean Percent Total Body Weight Loss|Percent total body weight loss calculated through 12 months post procedure|1 Year|||percentage of TBW||Standard Deviation|Mean
642326|NCT02279407|Secondary|Change From Baseline to Week 12 in % Liver Fat (Comparison Between Active Treatment Groups)|To evaluate the relative efficacy of the combination of Epanova and dapagliflozin versus Epanova alone and dapagliflozin alone with respect to reduction in % liver fat at the end of 12 weeks of double-blind treatment. Treatment effect in liver fat reduction (%) was assessed using a mixed linear model with the change from baseline on logarithmic scale as response variable and the logarithm of the baseline value as covariate, treatment as fixed effect, and center as random effect. The treatment effect was then back-transformed to original scale as Geometric mean ratio and presented as percentage change from baseline.|12 weeks|The Full Analysis Set included all randomized patients, regardless of whether they took trial medication or not. In this set, patients were analyzed according to their randomized treatment assignment.||ratio of % liver fat||95% Confidence Interval|Geometric Mean
642327|NCT02279407|Primary|Change From Baseline to Week 12 in % Liver Fat as Assessed by MRI (Comparison Versus Placebo)|To evaluate the efficacy of the combination therapy (Epanova + Dapagliflozin) when compared to placebo with respect to reduction in liver fat content (%) at the end of 12 weeks of double-blinded treatment. Treatment effect in liver fat reduction (%) was assessed using a mixed linear model with the change from baseline on logarithmic scale as response variable and the logarithm of the baseline value as covariate, treatment as fixed effect, and center as random effect. The treatment effect was then back-transformed to original scale as Geometric mean ratio and presented as percentage change from baseline.|12 weeks|The Full Analysis Set included all randomized patients, regardless of whether they took trial medication or not. In this set, patients were analyzed according to their randomized treatment assignment.||ratio of % liver fat||95% Confidence Interval|Geometric Mean
642329|NCT02278783|Secondary|Frequency of Clinical Benefit (Stable Disease, Partial and Complete Response)|To determine the frequency of clinical benefit (stable disease, partial, and complete response) according to RECIST (Response Evaluation Criteria in Solid Tumors) 1.1 criteria|Scans will be done every 2 cycles (every 2 months) for disease assessment. Patients on average will be on treatment for 4-6 months|Study was terminated early, no analysis performed.|||||
642330|NCT02278783|Secondary|Estimate Progression Free Survival|To estimate progression free survival for patients treated with this regimen|At 6 months patients will be checked for PFS, and compared to the expected probability of the patient being alive and progression-free for at least 6 months|Study was terminated early, no analysis performed.|||||
642331|NCT02278783|Primary|Incidence of Adverse Events (Grade 2 or Higher), Assessed According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0|To determine the nature and degree of toxicity of Regorafenib in this cohort of patients. Toxicity will be summarized by attribution: regorafenib-related adverse events grade 2 or higher will be reported.|Patients will remain on treatment for approximately 4-6 months on average.|||participants|||Number
642332|NCT02278783|Primary|6 Month Progression Free Survival (PFS)|To evaluate the anti-tumor activity of Regorafenib as measured by progression free survival at 6 months in patients with recurrent gynecological cancers|Patients will be checked for PFS after 6 months on treatment|||participants|||Number
642333|NCT02278640|Secondary|Percentage of Subjects Achieving Hemostasis at the Ovarian Pedicle on the Right Side.|"Hemostasis of the named vessel or pedicle is a dichotomous variable (i.e. yes or no). Yes is defined as the hemostatic transection of the uterine vasculature (left / right) with at least one use of the device in Advanced Hemostasis mode (a completed cycle with the second activation tone heard) without the use of additional hemostatic measures (i.e. tissue sealers, cautery devices, hemoclips, staples, sutures, fibrin sealants, etc.) other than the Harmonic ACE®+7 device. Multiple applications of the Advanced Hemostasis mode and/or additional applications of the device in a maximum (MAX) or minimum (MIN) mode are allowed."|Intraoperative|Safety Set With OP transection - All subjects in whom the procedure was started and for whom the transection of the ovarian pedicle was attempted.||percentage of participants||95% Confidence Interval|Number
642334|NCT02278640|Secondary|Percentage of Subjects Achieving Hemostasis at the Ovarian Pedicle on the Left Side.|"Hemostasis of the named vessel or pedicle is a dichotomous variable (i.e. yes or no). Yes is defined as the hemostatic transection of the uterine vasculature (left / right) with at least one use of the device in Advanced Hemostasis mode (a completed cycle with the second activation tone heard) without the use of additional hemostatic measures (i.e. tissue sealers, cautery devices, hemoclips, staples, sutures, fibrin sealants, etc.) other than the Harmonic ACE®+7 device. Multiple applications of the Advanced Hemostasis mode and/or additional applications of the device in a maximum (MAX) or minimum (MIN) mode are allowed."|Intraoperative|Safety Set With OP transection - All subjects in whom the procedure was started and for whom the transection of the ovarian pedicle was attempted.||percentage of participants||95% Confidence Interval|Number
642335|NCT02278640|Primary|Percentage of Subjects Achieving Hemostasis at the Named Vessel/Pedicle (UA or UP) on the Right Side.|"Hemostasis of the named vessel or pedicle is a dichotomous variable (i.e. yes or no). Yes is defined as the hemostatic transection of the uterine vasculature (left / right) with at least one use of the device in Advanced Hemostasis mode (a completed cycle with the second activation tone heard) without the use of additional hemostatic measures (i.e. tissue sealers, cautery devices, hemoclips, staples, sutures, fibrin sealants, etc.) other than the Harmonic ACE®+7 device. Multiple applications of the Advanced Hemostasis mode and/or additional applications of the device in a maximum (MAX) or minimum (MIN) mode are allowed."|Intraoperative|Safety Set - all subjects in whom the procedure was started.||percentage of participants||95% Confidence Interval|Number
642369|NCT02276274|Secondary|Number of Participants With Significant Change From Baseline in Electrocardiograms|Clinically significant change in electrocardiograms observed at any time point are reported.|3 hours prior to administration (predose) and 2, 24 and 72 hours postdose|Safety analysis set: All participants who receive at least one dose of study medication.||participants|||Number
648269|NCT02107014|Primary|Change in IL-21 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].|||pg/mL||95% Confidence Interval|Median
642336|NCT02278640|Primary|Percentage of Subjects Achieving Hemostasis at the Named Vessel/Pedicle (UA or UP) on the Left Side.|"Hemostasis of the named vessel or pedicle is a dichotomous variable (i.e. yes or no). Yes is defined as the hemostatic transection of the uterine vasculature (left / right) with at least one use of the device in Advanced Hemostasis mode (a completed cycle with the second activation tone heard) without the use of additional hemostatic measures (i.e. tissue sealers, cautery devices, hemoclips, staples, sutures, fibrin sealants, etc.) other than the Harmonic ACE®+7 device. Multiple applications of the Advanced Hemostasis mode and/or additional applications of the device in a maximum (MAX) or minimum (MIN) mode are allowed."|Intraoperative|Safety Set - all subjects in whom the procedure was started.||percentage of participants||95% Confidence Interval|Number
642337|NCT02278614|Primary|Non-inferiority of T2347 Compared With Xalacom® on Change in Mean IOP at 9.00 am (± 1 Hour) Between the Baseline (Day 0) and Day 84 in the Worse Eye|"the non-inferiority of T2347 unpreserved eye drops compared with Xalacom® on change in mean IOP at 9.00 am (± 1 hour) between the baseline (Day 0) and Day 84 in the worse eye.
Two relevant time points are considered for this primary criteria: D0 and Day 84."|Day 84|"The primary efficacy analysis (mean change in IOP from baseline to Day 84) was performed on the mITT set (236 patients).
mITT set: All ITT patients with at least one baseline and one post-randomisation efficacy assessment following study treatment.
242 patients described in the participant flow correpsond to the ITT & Safety set."||mm Hg||Standard Error|Least Squares Mean
642338|NCT02278484|Secondary|Number of Subjects Who Undergo a Revision or Additional Surgery During the Study|Any surgical intervention that is performed in the sinus(es) following the index procedure will be reported|Procedure-6 month follow up|All participants||Participants|||Count of Participants
642339|NCT02278484|Secondary|Change in Quality of Life From Baseline Through Completion|Change in sinonasal symptom severity between the baseline preprocedure assessment and follow-up assessment. Sinus symptom severity is measured using the Sinus and Nasal Quality of Life Survey (SN-5) that is a validated tool for use in pediatric patients (completed by caregivers). The 5 survey items are scored from 1 (best) to 7 (worst) and averaged to provide an overall score.|Baseline to 6-month follow-up|All participants||Units on a scale||Standard Deviation|Mean
642340|NCT02278484|Primary|Complications|Number of subjects who experience complications. Complications are defined as serious device or procedure related adverse events.|Index procedure through 3-month follow-up|All participants||participants|||Number
642341|NCT02278484|Primary|Technical Success: Sinuses Successfully Treated With Balloon Dilation|Number of successful dilations out of all attempted dilations. Success is defined as the device successfully delivered to the target sinus, inflated, deflated, and withdrawn from the treated sinus.|Index procedure|All sinus dilations attempted in all participants||sinus dilation attempts|Sinuses||Number
642342|NCT02278146|Secondary|Overactive Bladder Arm|Percentage of participants with less daily voids from baseline to 3 weeks.|up to 3 weeks|||percentage of participants|||Number
642343|NCT02278146|Secondary|Stress Incontinence Arm|Percentage of participants with less daily leaks from baseline to 3 weeks.|up to 3 weeks|||percentage of subjects|||Number
642344|NCT02278146|Primary|Number of Participants Who Used the ParaPatch System With Adverse Events Through the Completion of the Study|Documentation, follow-up and characterization of all adverse events in all subjects who use the ParaPatch System, through the completion of the study.|up to 3 weeks|||participants|||Number
642345|NCT02277691|Secondary|Change From Baseline in Home Sitting Clinic Systolic and Diastolic Blood Pressure at Each Visit|The change in home morning SPB and DBP measured at End of Week 12, End of Treatment (Up to Week 52) relative to baseline.|Baseline (End of Run-in Period, Week 0), End of Week 12 and End of Treatment (Up to Week 52)|The full analysis set is defined as the participants who received at least 1 dose of the study drug for the treatment period. Here 'n' is number of participants analysed at the given time­point.||mmHg||Standard Deviation|Mean
642346|NCT02277691|Secondary|Change From Baseline in Office Trough Sitting Clinic Systolic and Diastolic Blood Pressure at Each Visit|The change in office trough SBP and DBP measured at Weeks 12 last observation was carried forward (LOCF) and 52 (LOCF) relative to baseline. Sitting blood pressure was measured at least 3 times. Each measurement session ended once blood pressure was found stable at 2 consecutive measurements. The average of the last 2 measurements of office sitting blood pressure was used.|Baseline (End of Run-in Period, Week 0) and Weeks 12 (LOCF) and 52 (LOCF)|The full analysis set is defined as the participants who received at least 1 dose of the study drug for the treatment period. Here 'n' is number of participants analyzed at the given timepoint.||mmHg||Standard Deviation|Mean
642347|NCT02277691|Primary|Number of Participants With Markedly Abnormal Clinical Laboratory Tests|The number of participants with any markedly abnormal clinical laboratory test values collected throughout study. RBC = Red blood cells, ALT = alanine aminotransferase, AST = aspartate aminotransferase, GGT = gamma-glutamyl transferase, LLN = lower limit of normal or lower reference limit, ULN = upper limit of normal or upper reference limit. Laboratory vallues were considered abnormal if they were beyond the values defined in categories.|Baseline up to Week 52|The safety analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period.||Participants|||Count of Participants
642348|NCT02277691|Primary|Number of Participants With Treatment Emergent Adverse Event (TEAE) Related to Electrocardiogram (ECG)|Reported TEAE is categorized into cardiac disorders and investigations system organ class (SOC) related to ECG.|Baseline up to Week 52|The safety analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period.||Participants|||Count of Participants
642349|NCT02277691|Primary|Number of Participants With Treatment Emergent Adverse Event (TEAE) Related to Body Weight|Reported TEAE is categorized into investigations System Organ Class (SOC) related to body weight.|Baseline up to Week 52|The safety analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period.||Participants|||Count of Participants
642350|NCT02277691|Primary|Number of Participants With Markedly Abnormal Vital Signs Values|Vital signs included supine and standing systolic and diastolic blood pressure (SBP and DBP) respectively and office sitting pulse. Vital signs were considered abnormal if they were beyond the values defined in categories.|Baseline up to Week 52|The safety analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period.||Participants|||Count of Participants
643877|NCT02226198|Secondary|LDL C/HDL C|Efficacy in terms of low density lipoprotein cholesterol (LDL C) / high density lipoprotein cholesterol (HDL C)|Samples taken at Day 42 (week 6) and Day 84 (week 12)|||ratio||Standard Deviation|Mean
642351|NCT02277691|Primary|Number of Participants Who Experience at Least One Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A Serious Adverse Event (SAE) A serious is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.|Baseline up to Week 52|The safety analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period.||Participants|||Count of Participants
642352|NCT02277626|Primary|Comfort Level After Receiving Therapy With Either ElectroFlo 5000 / Vest|Comfort assessed on a scale of 1-10 by patients after therapy after each visit (1 being most comfortable, 10 being most un-comfortable)|End of study visit per intervention|||units on a scale||Full Range|Mean
642353|NCT02277626|Primary|Pulmonary Function Measured as a Percent Predicted AFTER Therapy With Either ElectroFlo 5000 / Vest.|Comparison of pulmonary function by doing spirometry testing on study patients during their Day 1 & Day 2 therapy sessions. Will also compare the results based on the therapies they receive.|End of study visit per intervention|||percentage of predicted value||Full Range|Mean
642354|NCT02277626|Primary|Pulmonary Function Measured as a Percent Predicted BEFORE Therapy With Either ElectroFlo 5000 / VEST.|Comparison of pulmonary function by doing spirometry testing on study patients during their Day 1 & Day 2 therapy sessions. Will also compare the results based on the therapies they receive.|End of study visit per intervention|||percentage of predicted value||Full Range|Mean
642355|NCT02277626|Secondary|Dry Sputum Weight|Sputum was collected in pre-measured cups in a blinded fashion, dessicated and measured dry|End of study visit per intervention|||gram||Full Range|Mean
642356|NCT02277626|Primary|Wet Sputum Weight|Sputum was collected in pre-measured cups in a blinded fashion|End of study visit per intervention|||grams||Full Range|Mean
642357|NCT02277249|Primary|Patient Discomfort With Digoxin Injection (Pain Score)|"Pain score (indicated by patient reporting pain level from 0 (no hurt) to 5 (hurts worst) at time of digoxin injection)"|At time of study (immediate)|||Units on a scale||Standard Deviation|Mean
642358|NCT02277119|Primary|Optic Disc Measurement (Cup Size)|Reporting of the Cup size difference between the Maestro and iVue|1 Hour|||Microns cubed||Standard Deviation|Mean
642359|NCT02277119|Primary|Full Retinal Thickness Measurement|Full Retinal Thicknesses Measurement|1 Hour|Glaucomatous eyes were not scanned and analyzed in the Full Retina Thickness portion of the study. Since the imaging is done in a different area of the eye compare to Retinal Nerve Fiber Layer participants analyzed will be different between these measurement areas.||Microns||Standard Deviation|Mean
642360|NCT02277119|Primary|Retinal Nerve Fiber Layer (RNFL) Thickness Measurements|RNFL thickness measured|1 Hour|||Microns||Standard Deviation|Mean
642361|NCT02277119|Primary|Optic Disc Measurements (Optic Disc Size)|Reporting of the Optic Disc Size difference between the Maestro and iVue|1 Hour|||Mircrons squared||Standard Deviation|Mean
642362|NCT02277093|Secondary|Overall Survival (OS)|-The follow-up time for OS was calculated from the start of treatment until death or on the final collection date of data on 10/27/2016.|Through completion of follow-up (median follow-up was 6.61 months)|||months||95% Confidence Interval|Median
642363|NCT02277093|Secondary|Time to Progression (TTP)||Through completion of follow-up (median follow-up was 6.61 months)|Only patients who had their first measurement scans were evaluable for this outcome measure.||months||Standard Deviation|Mean
642364|NCT02277093|Secondary|Overall Response Rate (ORR)|"The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The patient's best response assignment will depend on the achievement of both measurement and confirmation criteria.
Using RECIST 1.1
The follow-up time was calculated from the start of treatment until death or on the final collection date of data on 10/27/2016."|Through completion of follow-up (median follow-up was 6.61 months)|||Participants|||Count of Participants
642365|NCT02277093|Secondary|Toxicity Profile and Tolerability as Measured by Reportable Adverse Events|"The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.
Reportable adverse events will be tracked for 28 days following the last day of study treatment. For the purposes of this protocol, reportable adverse events are events that are greater than or equal to grade 2 and are considered possibly, probably, or definitely related to study treatment."|Up to 28 days following last day of study treatment|||adverse event|||Number
642366|NCT02277093|Primary|Progression-free Survival (PFS)|"PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.
Progression - at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).
Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase."|Through completion of follow-up (median follow-up was 6.61 months)|||months||Inter-Quartile Range|Median
642367|NCT02276560|Primary|Rate of N2 Nodal Clearance|N2 disease is defined as involvement of the ipsilateral mediastinal and/or subcarinal lymph nodes; if disease is cleared form these locations, then there is N2 nodal clearance|3 Months|The only patient registered before funding was withdrawn could not complete treatment due to adverse events.|||||
642368|NCT02276274|Secondary|Number of Participants With Laboratory-related Treatment Emergent Adverse Events (TEAEs)|Laboratory assessments included hematology, serum chemistry and urinalysis. Any laboratory-related TEAE reported at any time point were reported in this measure.|3 hours prior to administration (predose), 24 and 72 hours postdose|Safety analysis set: All participants who receive at least one dose of study medication.||participants|||Number
642370|NCT02276274|Secondary|Number of Participants With Clinically Significant Change From Baseline in Body Weight|Clinically significant change participant's body weight observed at any time point are reported.|3 hours prior to administration (predose), 24 and 72 hours postdose|Safety analysis set: All participants who receive at least one dose of study medication.||participants|||Number
642371|NCT02276274|Secondary|Number of Participants With Clinically Significant Change From Baseline in Vital Signs|Vital signs included body temperature (infra-axillary), supine blood pressure resting more than 5 minutes (systolic and diastolic [Millimeters of mercury]), respiratory rate and pulse (beats per minute). Clinically significant change in vital signs observed at any time point are reported.|3 hours prior to administration (predose) and 2, 24 and 72 hours postdose|Safety analysis set: All participants who receive at least one dose of study medication.||participants|||Number
642372|NCT02276274|Secondary|Number of Participants Reporting 1 or More Treatment-emergent Adverse Events|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|Baseline up to the day of discharge (Day 4) in the second intervention period|Safety analysis set: All participants who receive at least one dose of study medication.||participants|||Number
642373|NCT02276274|Secondary|Tmax: Time to Reach Emax|Time to reach Emax for the first time was determined from the inhibition-time curve.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours postdose|Pharmacodynamic analysis set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacodynamics.||hour||Full Range|Median
642374|NCT02276274|Secondary|Emax: Maximum Inhibition Rate of Plasma DPP-4 Activity|Maximum inhibition rate of plasma DPP-4 activity was determined from the inhibition-time curve.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours postdose|Pharmacodynamic analysis set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacodynamics.||percentage of inhibition||Standard Deviation|Mean
642375|NCT02276274|Secondary|AUC (0-24): Area Under the Inhibition Rate of Plasma DPP-4 Activity-time Curve From Time 0 to 24 Hours|Area under the inhibition rate of plasma DPP-4 activity-time curve from time 0 to 24 hours was determined from the inhibition-time curve.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours postdose|Pharmacodynamic analysis set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacodynamics.||percentage of inhibition*hour||Standard Deviation|Mean
642376|NCT02276274|Secondary|DPP-4 Activity|DPP-4 activity was assessed from the plasma samples collected from the participants.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours postdose|Pharmacodynamic analysis set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacodynamics.||nanomole/minute/milliliter (nmoL/min/mL)||Standard Deviation|Mean
642377|NCT02276274|Secondary|Inhibition Rate of Dipeptidyl-peptidase-4 (DPP-4) Activity|DPP-4 activity and inhibition rate of DPP-4 activity was assessed from the plasma samples collected from the participants. Inhibition of DPP-4 enzyme was used to determine the antihyperglycemic activity of the investigational product.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours postdose|Pharmacodynamic analysis set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacodynamics.||percentage of inhibition||Standard Deviation|Mean
642378|NCT02276274|Primary|CLr: Renal Clearance of Metformin|CLr is a measure of apparent clearance of the drug from the urine.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.||L/hr||Standard Deviation|Mean
642379|NCT02276274|Primary|CLr: Renal Clearance of SYR-322Z|CLr is a measure of apparent clearance of the drug from the urine. The clearance is the rate at which waste substances are cleared from the blood.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.||L/hr||Standard Deviation|Mean
642380|NCT02276274|Primary|Urinary Excretion Ratio of Metformin From 0 to 48 Hours Postdose|Cumulative urinary excretion ratio of metformin was calculated as the percentage of metformin dose.|0 to 48 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.||percentage of dose||Standard Deviation|Mean
642381|NCT02276274|Primary|Urinary Excretion Ratio of Metformin From 0 to 24 Hours Postdose|Cumulative urinary excretion ratio of metformin was calculated as the percentage of metformin dose.|0 to 24 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.||percentage of dose||Standard Deviation|Mean
642382|NCT02276274|Primary|Urinary Excretion Ratio of Metformin From Time 0 to 12 Hours Postdose|Cumulative urinary excretion ratio of metformin was calculated as the percentage of metformin dose.|0 to 12 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.||percentage of dose||Standard Deviation|Mean
642453|NCT02274792|Secondary|Percentage of Participants With Positive Anti-etanercept Neutralizing Antibody Response at Week 12|Samples confirmed to be positive on the binding assay were subsequently tested in a non-cell based assay to determine neutralizing activity against etanercept.|Week 12|Participants with a positive anti-etanercept antibody binding response at week 12||percentage of participants||95% Confidence Interval|Number
642383|NCT02276274|Primary|Urinary Excretion Ratio of SYR-322 Metabolites M-I and M-II From 0 to 72 Hours Postdose|Cumulative urinary excretion ratio of SYR-322 metabolites M-I and M-II was calculated as the percentage of SYR-322 dose.|0 to 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.||percentage of dose||Standard Deviation|Mean
642384|NCT02276274|Primary|Urinary Excretion Ratio of SYR-322 Metabolites M-I and M-II From 0 to 48 Hours Postdose|Cumulative urinary excretion ratio of SYR-322 metabolites M-I and M-II was calculated as the percentage of SYR-322 dose.|0 to 48 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.||percentage of dose||Standard Deviation|Mean
642385|NCT02276274|Primary|Urinary Excretion Ratio of SYR-322 Metabolites M-I and M-II From 0 to 24 Hours Postdose|Cumulative urinary excretion ratio of SYR-322 metabolites M-I and M-II was calculated as the percentage of SYR-322 dose.|0 to 24 hours post dose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.||percentage of dose||Standard Deviation|Mean
642386|NCT02276274|Primary|Urinary Excretion Ratio of SYR-322 Metabolites M-I and M-II From 0 to 12 Hours Postdose|Cumulative urinary excretion ratio of SYR-322 metabolites M-I and M-II was calculated as the percentage of SYR-322 dose.|0 to 12 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.||percentage of dose||Standard Deviation|Mean
642387|NCT02276274|Primary|Urinary Excretion Ratio of SYR-322Z From 0 to 72 Hours Postdose|Cumulative urinary excretion ratio of unchanged SYR-322 was calculated as the percentage of SYR-322 dose.|0 to 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.||percentage of dose||Standard Deviation|Mean
642388|NCT02276274|Primary|Urinary Excretion Ratio of SYR-322Z From 0 to 48 Hours Postdose|Cumulative urinary excretion ratio of unchanged SYR-322 was calculated as the percentage of SYR-322 dose.|0 to 48 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.||percentage of dose||Standard Deviation|Mean
642389|NCT02276274|Primary|Urinary Excretion Ratio of SYR-322Z From 0 to 24 Hours Postdose|Cumulative urinary excretion ratio of unchanged SYR-322 was calculated as the percentage of SYR-322 dose.|0 to 24 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.||percentage of dose||Standard Deviation|Mean
642390|NCT02276274|Primary|Urinary Excretion Ratio of SYR-322Z From 0 to 12 Hours Postdose|Cumulative urinary excretion ratio of unchanged SYR-322 was calculated as the percentage of SYR-322 dose.|0 to 12 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.||percentage of dose||Standard Deviation|Mean
642391|NCT02276274|Primary|Mean Residence Time (MRT) for Metformin|Mean residence time (MRT) calculated as area under the first moment plasma concentration-time curve (AUMC [0-inf]) divided by AUC (0-inf). AUMC (0-inf) is the area under the first moment plasma concentration-time curve from time 0 to infinity.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.||hr||Standard Deviation|Mean
642392|NCT02276274|Primary|Apparent Clearance After Extra Vascular Administration (CL/F) for Metformin|CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided AUC (0-inf), expressed in L/hr.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.||L/hr||Standard Deviation|Mean
642393|NCT02276274|Primary|Terminal Phase Elimination Half-life (T1/2) for Metformin|Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.||hr||Standard Deviation|Mean
642394|NCT02276274|Primary|Apparent Terminal Elimination Rate Constant (λz) for Metformin|Terminal elimination rate constant, calculated as the negative of the slope of the log-linear regression of the natural logarithm concentration-time curve during the terminal phase.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.||hr^-1||Standard Deviation|Mean
642395|NCT02276274|Primary|AUC (0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Metformin|AUC (0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.||ng*hr/mL||Standard Deviation|Mean
642396|NCT02276274|Primary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Metformin|Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.||hr||Full Range|Median
642397|NCT02276274|Primary|Cmax: Maximum Observed Plasma Concentration for Metformin|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.||ng/mL||Standard Deviation|Mean
642398|NCT02276274|Primary|MRT (0-tlqc): Mean Residence Time From Time 0 to Time of the Last Quantifiable Concentration (Tlqc) for Metformin|MRT (0-tlqc) is a measure of the mean residence time from time 0 to time of the last quantifiable concentration (tlqc) calculated as MRT (0-tlqc) =AUMC (0-tlqc)/AUC (0-tlqc). AUMC (0-tlqc) is the area under the first moment plasma concentration-time curve from time 0 to time of the last quantifiable concentration (tlqc), calculated using the linear trapezoidal rule.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose|Pharmacokinetic set: Subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.||hr||Standard Deviation|Mean
642399|NCT02276274|Primary|AUC (0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Metformin|AUC (0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC [0-tlqc]).|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.||ng*hr/mL||Standard Deviation|Mean
642400|NCT02276274|Primary|AUC (0-48): Area Under the Plasma Concentration-time Curve From Time 0 to 48 Hours Postdose for Metformin|AUC (0-48) is measure of area under the curve from time 0 to 48 hours post dose.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.||ng*hr/mL||Standard Deviation|Mean
642401|NCT02276274|Primary|Mean Residence Time (MRT) for SYR-322 Metabolites M-I and M-II|Mean residence time (MRT) calculated as area under the first moment plasma concentration-time curve (AUMC [0-inf]) divided by AUC (0-inf). AUMC (0-inf) is the area under the first moment plasma concentration-time curve from time 0 to infinity.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics of each of the SYR-322 metabolites.||hr||Standard Deviation|Mean
642402|NCT02276274|Primary|Terminal Phase Elimination Half-life (T1/2) for SYR-322 Metabolites M-I and M-II|Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics of each of the SYR-322 metabolites.||hr||Standard Deviation|Mean
642403|NCT02276274|Primary|Apparent Terminal Elimination Rate Constant (λz) for SYR-322 Metabolites M-I and M-II|Terminal elimination rate constant, calculated as the negative of the slope of the log-linear regression of the natural logarithm concentration-time curve during the terminal phase.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics of each of the SYR-322 metabolites.||hr^-1||Standard Deviation|Mean
642404|NCT02276274|Primary|AUC (0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for SYR-322 Metabolites M-I and M-II|AUC (0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics of each of the SYR-322 metabolites.||ng*hr/mL||Standard Deviation|Mean
642405|NCT02276274|Primary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for SYR-322 Metabolites M-I and M-II|Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics of each of the SYR-322 metabolites.||hr||Full Range|Median
642406|NCT02276274|Primary|Cmax: Maximum Observed Plasma Concentration for SYR-322 Metabolites M-I and M-II|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics of each of the SYR-322 metabolites.||ng/mL||Standard Deviation|Mean
642407|NCT02276274|Primary|MRT (0-tlqc): Mean Residence Time From Time 0 to Time of the Last Quantifiable Concentration (Tlqc) for SYR-322 Metabolites M-I and M-II|MRT (0-tlqc) is a measure of the mean residence time from time 0 to time of the last quantifiable concentration (tlqc) calculated as MRT (0-tlqc) =AUMC (0-tlqc)/AUC (0-tlqc). AUMC (0-tlqc) is the area under the first moment plasma concentration-time curve from time 0 to time of the last quantifiable concentration (tlqc), calculated using the linear trapezoidal rule.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics of each of the SYR-322 metabolites.||hr||Standard Deviation|Mean
642408|NCT02276274|Primary|AUC (0-tlqc): Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for SYR-322 Metabolites M-I and M-II|AUC (0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC [0-tlqc]).|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics of each of the SYR-322 metabolites.||ng*hr/mL||Standard Deviation|Mean
642409|NCT02276274|Primary|AUC (0-72): Area Under the Plasma Concentration-time Curve From Time 0 to 72 Hours Post Dose for SYR-322 Metabolites M-I and M-II|AUC (0-72) is measure of area under the curve from time 0 to 72 hours post dose.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics of each of the SYR-322 metabolites.||ng*hr/mL||Standard Deviation|Mean
642410|NCT02276274|Primary|MRT (0-tlqc): Mean Residence Time From Time 0 to Time of the Last Quantifiable Concentration (Tlqc) for SYR-322Z|MRT (0-tlqc) is a measure of the mean residence time from time 0 to time of the last quantifiable concentration (tlqc) calculated as MRT (0-tlqc) =AUMC (0-tlqc)/AUC (0-tlqc). AUMC (0-tlqc) is the area under the first moment plasma concentration-time curve from time 0 to time of the last quantifiable concentration (tlqc), calculated using the linear trapezoidal rule.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic analysis set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.||hr||Standard Deviation|Mean
642411|NCT02276274|Primary|Mean Residence Time (MRT) for SYR-322Z|Mean residence time (MRT) calculated as area under the first moment plasma concentration-time curve (AUMC [0-inf]) divided by AUC (0-inf). (AUMC [0-inf]) is the area under the first moment plasma concentration-time curve from time 0 to infinity.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.||hr||Standard Deviation|Mean
642412|NCT02276274|Primary|Apparent Clearance After Extra Vascular Administration (CL/F) for SYR-322Z|CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided AUC (0-inf), expressed in liter/hour (L/hr).|3 hours prior to administration, and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 hours after administration|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.||L/hr||Standard Deviation|Mean
642413|NCT02276274|Primary|Terminal Phase Elimination Half-life (T1/2) for SYR-322Z|Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.||hr||Standard Deviation|Mean
642414|NCT02276274|Primary|Apparent Terminal Elimination Rate Constant (λz) for SYR-322Z|Terminal elimination rate constant, calculated as the negative of the slope of the log-linear regression of the natural logarithm concentration-time curve during the terminal phase.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.||hr^-1||Standard Deviation|Mean
642415|NCT02276274|Primary|AUC (0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for SYR-322Z|AUC (0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.||ng*hr/mL||Standard Deviation|Mean
642416|NCT02276274|Primary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for SYR-322Z|Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.||hour (hr)||Full Range|Median
642417|NCT02276274|Primary|Cmax: Maximum Observed Plasma Concentration for SYR-322Z|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.||ng/mL||Standard Deviation|Mean
642418|NCT02276274|Primary|AUC (0-tlqc): Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for SYR-322Z|AUC (0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC [0-tlqc]).|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.||ng*hr/mL||Standard Deviation|Mean
642454|NCT02274792|Secondary|Percentage of Participants With Positive Anti-etanercept Neutralizing Antibody Response at Week 24|Samples confirmed to be positive on the binding assay were subsequently tested in a non-cell based assay to determine neutralizing activity against etanercept.|Week 24|Participants with a positive anti-etanercept antibody binding response at week 24||percentage of participants||95% Confidence Interval|Number
642419|NCT02276274|Primary|AUC (0-72): Area Under the Plasma Concentration-time Curve From Time 0 to 72 Hours Postdose for Unchanged SYR-322 (SYR-322Z)|AUC (0-72) is measure of area under the curve from time 0 to 72 hours post dose.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.||nanogram*milliliter per hour (ng*hr/mL)||Standard Deviation|Mean
642420|NCT02275767|Secondary|% Residual Graft Material (Histological)|histologic determination of % residual graft material 18-20 weeks after ridge preservation surgery|18-20 weeks after ridge preservation|||percentage of total area||Standard Deviation|Mean
642421|NCT02275767|Primary|% Vital Bone Formation (Histological)|histologic determination of % vital bone formation 18-20 weeks after ridge preservation surgery|18-20 weeks after ridge preservation|||percentage of total area||Standard Deviation|Mean
642422|NCT02275611|Secondary|Change in Percentage Heavy Drinking Days|A heavy drinking day is defined by consumption of 5 or more standard drinks for men, 4 or more standard drinks for women. The outcome measure is the change in percentage of heavy drinking days as determine by the Timeline Followback interview between the baseline 90 day period and the first 4 weeks of intranasal test treatment in the outpatient setting.|90 days prior to admission and 4 weeks in the outpatient setting|This assessment was done only in the outpatient phase.||percentage of heavy drinking days change||Standard Deviation|Mean
642423|NCT02275611|Secondary|Total mg of Lorazepam for Detoxification|"Cumulative lorazepam received (2 mg doses)
After initiation of test treatments, CIWA scores and vital signs were obtained every 4 hours or whenever subjects or staff reported/observed significant increases in symptoms. Lorazepam (2 mg dose) was given if CIWA scores were >7, diastolic blood pressure rose to >120, or heart rate rose to >110. An additional 2 mg was given 1 hour after each lorazepam dose if CIWA scores and/or vital signs remained elevated."|48 hours after initiation of intranasal test doses|This assessment was done only in the inpatient withdrawal phase.||cumulative lorazepam doses (mg)||Standard Deviation|Mean
642424|NCT02275611|Primary|Change in Clinical Institute Withdrawal Assessment for Alcohol (CIWA) Score|The Clinical Institute Withdrawal Assessment for Alcohol (CIWA) measure is a ten item measure of alcohol withdrawal symptoms. The CIWA total score is the summation of 10 questions, with a range from 0 (little to no withdrawal) to 67 (worse alcohol withdrawal).|Change in scores from before initiation of intranasal test treatment and the first 48 hours after initiation of intranasal test treatments|This assessment was done only in the inpatient withdrawal phase.||units on a scale||Standard Deviation|Mean
642425|NCT02275546|Primary|Percentage of Participants With Vaginal Ring Expulsion Within 48 Hours of Insertion|Participants completed a Follow-Up Questionnaire in which they asked if they experienced vaginal ring expulsion. Their answers were recorded and evaluated.|Up to 48 hours after vaginal ring insertion|Per Protocol Population, which excluded participants due to important deviations from the protocol that could have substantially affected the results of the efficacy endpoints.||Percentage of participants||95% Confidence Interval|Number
642426|NCT02275546|Primary|Percentage of Participants With Successful Ring Insertion|Participants completed a Post-Insertion Questionnaire in which they were asked about their experience inserting the vaginal ring. Their answers were recorded and evaluated.|Day 1 (immediately after vaginal ring insertion)|Per Protocol Population, which excluded participants due to important deviations from the protocol that could have substantially affected the results of the efficacy endpoints.||Percentage of participants||95% Confidence Interval|Number
642427|NCT02275481|Primary|Number of Participants Experiencing All-cause Hospitalization or Emergency Department Visit Within 90-days of Initiating Treatment|Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only summary tables and listings, disposition, demographics, vital signs, AEs and listings of safety data were generated.|Up to 90 days|Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol.|||||
642428|NCT02275364|Secondary|VNR: Change From Baseline to 20 Minutes After Decongestant Administration, and Post Application of the Marketed Nasal Strip After Decongestant Administration|Participants provided their response for VNR on a scale of 0 to 10 (0 = Breathe Freely and 10 = Totally Blocked) how easy it was to breathe through nose at a given time.|Upto 2 hours|Per-Protocol (PP) Population: Participants successfully completing all conditions of the experiment on single visit day except whose data didn't meet quality standards (problems with devices/software or participant (excessive head-motion during fMRI, inadequate performance of experimental tasks). Data of 2 participants didn't meet the standards.||Units on a scale||Standard Deviation|Mean
642429|NCT02275364|Secondary|Verbal Numerical Response (VNR): Change From Baseline to Immediately After Strip Application and 30 Minutes Post Application|Participants provided their response for VNR on a scale of 0 to 10 (0 = Breathe Freely and 10 = Totally Blocked) how easy it was to breathe through nose at a given time.|Upto 30 minutes|Per-Protocol (PP) Population: Participants successfully completing all conditions of the experiment on single visit day except whose data didn't meet quality standards (problems with devices/software or participant (excessive head-motion during fMRI, inadequate performance of experimental tasks). Data of 2 participants didn't meet the standards.||Units on a scale||Standard Deviation|Mean
642430|NCT02275364|Secondary|Breathing-related Cortical Activity (Blood Oxygen Level Dependent- Resting State)|"Regional measures of breathing-related cortical activity were derived by determining Functional Connectivity and Event-related percentage signal change.
Functional connectivity analyzes of fMRI data where spontaneous (i.e. while the participant is at rest) signal changes in one brain region are regressed against other regions, to identify regions sharing similar functional properties.
Event-related functional magnetic resonance imaging (efMRI) detects changes in the BOLD hemodynamic response to neural activity associated with certain event. In this case, the events were pre-defined by collecting additional data during the scan; participant respiration was determined using a simple pressure-sensitive respiration belt. Events time-locked to peak inspiration and expiration were defined separately, and regressed against brain activity, showing brain regions that were more or less active during each event type."|Upto 2.5 hours|Decongestant and Test Nasal Strip Plus Decongestant groups were not included in this outcome measure as it was prespecified to evaluate the effect on nasal strips on the breathing related brain activity without the use of nasal decongestant||% signal change||Standard Deviation|Mean
643878|NCT02226198|Secondary|TG (mmol/L)|Efficacy in terms of triglycerides (TG)|Samples taken at Day 42 (week 6) and Day 84 (week 12)|||mmol/L||Standard Deviation|Mean
642431|NCT02275364|Primary|Functional Measure: Blood Oxygen Level Dependent- Interoceptive Attention Task (Psychophysiological Interactive Analysis)|Regional measures of functional brain activity were to be derived from a breathing-related interoceptive task.|Upto 2.5 hours|Decongestant and Test Nasal Strip Plus Decongestant groups were not included in this outcome measure as it was pre-specified to evaluate the effect on nasal strips on the measure of brain activity without the use of nasal decongestant.||% signal change||Standard Deviation|Mean
642432|NCT02275364|Primary|Anatomical Measures: Volume (Multiple Volume Reading)|Determination of averaged volume reading during the MRI (Average of 8 sub-regions)|Upto 2.5 hours|Per-Protocol (PP) Population: Participants successfully completing all conditions of the experiment on single visit day except whose data didn't meet quality standards (problems with devices/software or participant (excessive head-motion during fMRI, inadequate performance of experimental tasks). Data of 7 participants didn't meet the standards.||mm^3||Standard Deviation|Mean
642433|NCT02275364|Primary|Cerebral Blood Flow (CBF)|CBF was derived from Arterial-Spin Labelling (ASL) scans. ASL data were analysed using custom Matlab code, which fits a CBF model to the raw perfusion data, in order to derive quantitative estimates of CBF in units of ml/100g/minute. The computed CBF maps were co-registered to the subject’s whole-brain T1-weighted anatomical scan (from the first scan session) in order to spatially divide the data into anatomical Regions of Interest (ROIs). The anatomical ROIs were themselves defined by nonlinear warping of a standard cytoarchitectonic atlas into the space of the subject’s T1 anatomical scan, using the FMRIB Software Library tool FNIRT. CBF data were extracted for a subset of these anatomical ROIs.|Upto 2.5 hours|Decongestant and Test Nasal Strip Plus Decongestant groups were not evaluated in this outcome measure as it was pre-specified to to analyze effect of nasal strips on the cerebral blood without the use of nasal decongestant.||ml/100g/min||Standard Deviation|Mean
642434|NCT02275364|Primary|Anatomical Measure: Volume (Single Volume Reading)|Determination of single volume reading derived from examination of the nasal passages and sinuses, during the MRI.|Upto 2.5 hours|Per-Protocol (PP) Population: Participants successfully completing all conditions of the experiment on single visit day except whose data didn't meet quality standards (problems with devices/software or participant (excessive head-motion during fMRI, inadequate performance of experimental tasks). Data of 7 participants didn't meet the standards.||mm^3||Standard Deviation|Mean
642435|NCT02275364|Primary|Functional Brain Activity: Blood Oxygen Level Dependent- Interoceptive Attention Task|Regional measures of functional brain activity to be derived from a breathing-related interoceptive task. This outcome measure was pre-specified to analyze effect on nasal strips on the functional brain activity without the use of nasal decongestant.|Upto 2.5 hours|Decongestant and Test Nasal Strip Plus Decongestant groups were not included in this outcome measure as it was pre-specified to analyze effect on nasal strips on the brain activity without the use of nasal decongestant||% Signal||Standard Deviation|Mean
642436|NCT02275364|Primary|Anatomical Measures : Cross Sectional Area|Determination of cross sectional area derived from examination of the nasal passages and sinuses using T1 weighted MRI scans.|Upto 2.5 hours|Per-Protocol (PP) Population: Participants successfully completing all conditions of the experiment on single visit day except whose data didn't meet quality standards (problems with devices/software or participant (excessive head-motion during fMRI, inadequate performance of experimental tasks). Data of 7 participants didn't meet the standards.||mm^2||Standard Deviation|Mean
642437|NCT02275156|Secondary|Mean Percent Change From Baseline in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9)|"Serum PCSK9 concentrations were determined using a qualified ELISA. The LLOQ of the assay was 15 ng/mL.
Log-transformed baseline PCSK9 was included in the model as a covariate and participant as a random effect."|Baseline and 4 hours, 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 50 and 57 days postdose|Safety analysis set||percent change||95% Confidence Interval|Geometric Mean
642438|NCT02275156|Secondary|Area Under the Effect Curve From Baseline to Day 57 (AUECday1-57) for Low-density Lipoprotein Cholesterol (LDL-C)|The derived log-transformed AUECday1-57 for direct LDL-C was analyzed using a mixed-effect analysis of variance model. Log-transformed baseline LDL-C was the covariate.|4 hours, 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 50 and 57 days postdose|Safety analysis set||mg/dL*day||95% Confidence Interval|Geometric Mean
642439|NCT02275156|Secondary|Number of Participants With Anti-evolocumab Antibodies|Blood samples were tested using an electrochemiluminescence-based bridging immunoassay to detect antibodies capable of binding to evolocumab.|57 days|Safety analysis set||participants|||Number
642440|NCT02275156|Secondary|Number of Participants With Clinically Relevant Vital Sign or Clinical Laboratory Changes|The investigator reviewed vital signs and laboratory test results and determined whether an abnormal value in an individual participant represented a clinically significant change from the participant’s baseline values.|57 days|Safety analysis set||participants|||Number
642441|NCT02275156|Secondary|Number of Participants With Adverse Events|"The severity of each adverse event was graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4. A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria:
fatal;
life threatening (places the participant at immediate risk of death);
requires in patient hospitalization or prolongation of existing hospitalization;
results in persistent or significant disability/incapacity;
congenital anomaly/birth defect;
other medically important serious event.
The investigator assessed whether each adverse event was possibly related to the study drug."|From the first dose of study drug up until Day 57|Safety analysis set (all participants who received at least 1 dose of study drug)||participants|||Number
642442|NCT02275156|Primary|Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC0-last) for Evolocumab||Predose and 4 hours, 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 50 and 57 days postdose|PK analysis set||day*μg/mL||Standard Deviation|Mean
642443|NCT02275156|Primary|Maximum Observed Serum Concentration (Cmax) of Evolocumab|Serum concentrations of evolocumab were measured by a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) of the assay was 800 ng/mL.|Predose and 4 hours, 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 50 and 57 days postdose|Pharmacokinetic (PK) analysis set (all participants for whom at least 1 PK parameter could be adequately estimated)||μg/mL||Standard Deviation|Mean
642455|NCT02274792|Secondary|Percentage of Participants With Positive Anti-etanercept Binding Antibody Response at Week 12||Week 12|Participants with available antibody response data at week 12||percentage of participants||95% Confidence Interval|Number
643879|NCT02226198|Secondary|TG (mg/dL)|Efficacy in terms of triglycerides (TG)|Samples taken at Day 42 (week 6) and Day 84 (week 12)|||mg/dL||Standard Deviation|Mean
642448|NCT02274948|Secondary|Change in Alanine Aminotransferase (ALT) Levels After One Year of Treatment With Matformin or Placebo|ALT was measured at baseline and one year after giving Metformin or Placebo. The difference is calculated by subtracting the baseline value from one year value (value at 1 year - value at base line value). Data of the 150 that were followed up throughout the period was included.|One year|||Iu/l||95% Confidence Interval|Mean
642449|NCT02274948|Secondary|Change in Triglyceride Levels After One Year of Treatment With Matformin or Placebo|Triglyceride was measured at baseline and one year after giving Metformin or Placebo. The difference is calculated by subtracting the baseline value from one year value (value at 1 year - value at base line value). Data of the 150 that were followed up throughout the period was included.|One year|||mmol/l||95% Confidence Interval|Mean
642450|NCT02274948|Secondary|Change in Insulin Resistance Measured by HOMA-IR After One Year Treatment With Metformin or Placebo|"HOMA IR (Homeostatic model -Insulin Resistance) was calculated at baseline and one year after giving Metformin or Placebo. The difference is calculated by subtracting the baseline value from one year value (value at 1 year - value at base line value). Data of the 150 that were followed up throughout the period was included.
Homeostatic model (HOMA-IR = fasting blood sugar(mmol/l) × fasting insulin(mmol/l) ÷ 22.5)"|One year|||units on a scale||95% Confidence Interval|Mean
642451|NCT02274948|Secondary|Change in Fasting Insulin After One Year of Treatment With Metformin or Placebo|Fasting insulin was calculated at baseline and one year after giving Metformin or Placebo. The difference is calculated by subtracting the baseline value from one year value (value at 1 year - value at base line value). Data of the 150 that were followed up throughout the period was included.|One year|||pmol/l||95% Confidence Interval|Mean
642452|NCT02274948|Primary|Change in BMI and Percentage Fat Mass Standard Deviation Scores After One Year of Treatment With Metformin or Placebo|BMI and Percentage Fat Mass SDS was calculated at baseline and one year after giving Metformin or Placebo. The difference is calculated by subtracting the baseline value from one year value (value at 1 year - value at base line value). Data of the 150 that were followed up throughout the period was included.|One year|||Z score||95% Confidence Interval|Mean
642457|NCT02274792|Primary|Percentage of Participants With Positive Anti-etanercept Binding Antibody Response During the Study|Seroreactivity to etanercept was evaluated using a validated enzyme-linked immunosorbent assay (ELISA).|Blood samples were collected for anti-etanercept antibody analysis before the administration of etanercept at baseline (day 1) and at week 12 and week 24.|Primary Antibody Analysis Set included all enrolled participants who received ≥ 1 dose of investigational product and had both a baseline and ≥ 1 post-baseline serum obtained for anti-etanercept antibody assessment, excluding participants with a negative antibody response at week 12 and missing antibody assessment at week 24.||percentage of participants||95% Confidence Interval|Number
642458|NCT02274688|Secondary|Drug Use Problems|The investigators used the Drug Abuse Screening Test (DAST-10) as a continuous outcome measure. DAST-10 scale scores range from 0 to 10, with higher scores representing a worse outcome. No subscales were used.|The investigators assessed at baseline, 1-, 3-, and 6-month.|||units on a scale||Standard Deviation|Mean
642459|NCT02274688|Secondary|Number of Participants With One or More Emergency Department Visits Over Time|The investigators used population level data on emergency department health service use for the intent-to-treat sample|The investigators assessed emergency department service use over the course of the study.|||Participants|||Count of Participants
642460|NCT02274688|Secondary|Number of Patients Carrying a Weapon|The investigation used a single yes/no item to assess whether the patient was carrying a weapon.|The investigators assessed at baseline, 1-, 3-, and 6-month.|||Participants|||Count of Participants
642461|NCT02274688|Secondary|Number of Participants With Suicidal Ideation|The investigators used PHQ-9 item 9 to assess suicidal ideation. For the analysis, a score of > 0 on item 9 of PHQ-9 was considered a positive endorsement and a worse outcome.|The investigators assessed at baseline, 1-, 3-, and 6-month.|||Participants|||Count of Participants
642462|NCT02274688|Secondary|Functional Status|The investigators used the Medical Outcomes Study Short Form healthy survey (MOS SF-12/36) physical components summary to assess physical function. The minimum and maximum scores are 0-100 with higher scores representing a better outcome. No other subscales will be used.|The investigators assessed at baseline, 1-, 3-, and 6-month.|||units on a scale||Standard Deviation|Mean
642463|NCT02274688|Secondary|Alcohol Use Problems|The investigators used the Alcohol Use Disorders Identification Test (AUDIT) as a continuous measure. The 10-item scale score ranges from 0-40, with higher values indicating a worse outcome. No sub scales were used.|The investigators assessed at baseline, 1-, 3-, and 6-month.|||units on a scale||Standard Deviation|Mean
642464|NCT02274688|Primary|Change in Depression Symptoms Over the Course of the Six Months After Injury|The investigators used the Patient Health Questionnaire (PHQ-9) as a continuous measure, with scores ranging from 1 to 27. Higher scores represent a worse outcome. No subscales were used.|The investigators assessed at baseline, 1-, 3-, and 6-month.|||units on a scale||Standard Deviation|Mean
642465|NCT02274688|Primary|Change in Post Traumatic Stress Disorder (PTSD) Symptoms Over the Course of the Six Months After Injury|The investigators used the PTSD Checklist - Civilian (PCL-C) as a continuous measure. The scoring of the scale ranges from a minumum of 17 to a maximum of 85, with higher scores indicating a worse outcome. No subscales were used.|The investigators assessed at baseline, 1-, 3-, and 6-month.|||units on a scale||Standard Deviation|Mean
642466|NCT02274688|Primary|Change in Post Traumatic Concerns Over the Course of the Six Months After Injury|The primary outcome is the endorsement of ≥1 severe posttraumatic concerns.|The investigators assessed at baseline, 1-, 3-, and 6-month.|||Participants|||Count of Participants
642467|NCT02274675|Secondary|Wrist's Active Range of Motion|"Introduction: Wrist's active range of motion (AROM) is a measurement to identify how far the person's joints range can move in by moving with their own effort.
Scores: The score is measured in terms of angular degree, where the higher the degree of motion the better the person condition. The total normalized AROM for normal wrist flexion-extension is about 144 angular degree, a person who is able to achieve or over this range consider normal or in good condition in this study. The minimum angular degree is 0.
Procedure: The wrist's AROM will be measured by using the CR2-Haptic robot, where the subject will hold the handle at forearm, subject will be guided to sit upright with shoulder abducted at 30-60’ and elbow flexed at 90-120’ supported by an adjustable arm rest with strap and the subject will move their wrist to maximum range in both direction. The moving range will be recorded by the robot and stored as report in its software."|Active range of motion of wrist at week 6|Stroke subjects in rehabilitation centre.||Angular degree||Standard Deviation|Mean
642468|NCT02274675|Secondary|Wrist's Passive Range of Motion|"Introduction: Wrist's passive range of motion (PROM) is a measurement to identify how far the person's joints range can move in flexion-extension directed by a person manually.
Scores: The score is measured in terms of angular degree, where the higher the degree of motion the better the person condition. The total normalized PROM for normal wrist flexion-extension is about 164 angular degree, a person who is able to achieve or over this range consider normal or in good condition in this study. The minimum angular degree is 0.
Procedure: The wrist PROM will be measured by using the CR2-Haptic robot, where the subject will hold the handle, subject will be guided to sit upright with shoulder abducted at 30-60’ and elbow flexed at 90-120’ supported by an adjustable arm rest with strap and the wrist will be moved manually by the therapist to access the passive range of motion. The moving range will be recorded by the robot and store as report in its software."|Passive range of motion of wrist at week 6|Stroke subjects in rehabilitation centre.||Angular degree||Standard Deviation|Mean
642469|NCT02274675|Secondary|Forearm's Passive Range of Motion|"Introduction: Forearm's passive range of motion (PROM) is a measurement to identify how far the person's joints range can move in pronation-supination directed by a person manually.
Scores: The score is measured in terms of angular degree, where the higher the degree of motion the better the person condition.The normalized forearm pronation-supination is about 169 angular degree, a person who is able to achieve or over this range is considered normal or in good condition in this study. The minimum angular degree is 0.
Procedure: The forearm PROM will be measured by using the CR2-Haptic robot, where the subject will hold the handle at forearm, subject will be guided to sit upright with shoulder abducted at 30-60’ and elbow flexed at 90-120’ supported by an adjustable arm rest with strap and the forearm will be moved manually by the therapist to access the passive range of motion. The moving range will be recorded by the robot and stored as report in its software."|Passive range of motion of forearm at week 6|Stroke subjects in rehabilitation centre.||Angular degree||Standard Deviation|Mean
648270|NCT02107014|Primary|Change in IL-18 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].|||pg/mL||95% Confidence Interval|Median
642470|NCT02274675|Secondary|Forearm's Active Range of Movement|"Introduction: Forearm's active range of motion (AROM) is a measurement to identify how far the person's joints range can move in pronation-supination by moving with their own effort.
Scores: The score is measured in terms of angular degree, where the higher the degree of motion the better the person condition. The normalized AROM for normal forearm pronation-supination is about 157 angular degree, a person who is able to achieve or over this range consider normal or in good condition in this study. The minimum angular degree will be 0.
Procedure: The forearm AROM will be measured by using the CR2-Haptic robot, where the subject will hold the handle at forearm, subject will be guided to sit upright with shoulder abducted at 30-60’ and elbow flexed at 90-120’ supported by an adjustable arm rest with strap and the subject will move their forearm to maximum range in both direction. The moving range will be recorded by the robot and stored as report in its software."|Active range of motion of forearm at week 6|Stroke subjects in rehabilitation centre.||Angular degree||Standard Deviation|Mean
642471|NCT02274675|Secondary|Spasticity Level of Wrist|"Introduction: The spasticity level of wrist is measured by using Modified Ashworth Scale. It measures resistance during passive soft-tissue stretching. This measure will only measure the wrist component, as forearm component is not included in this scale.
Scoring: The total or maximum scores for the subscale is 4 and the minimum is 0 score. Higher scores indicates the higher the tone, lower score indicates less tone. 0 score indicates normal tone and no increase in tone, while 4 scores indicate affected part rigid in flexion or extension. All the scores will be summed.
Procedure: The measuring procedure starts by holding the elbow as straight as possible at forearm pronated. Then, the patient's wrist is moved from maximum possible flexion to maximum possible extension. The test is performed up tp maximum of 3 times to avoid the influence of the effect of stretch."|Spasticity level of wrist at week 6|Stroke subjects in rehabilitation centre.||Scores||Standard Deviation|Mean
642472|NCT02274675|Secondary|Motor Function Assessment of Hand Movement|"Introduction: Motor function that are related to wrist and forearm are measured using the Motor Assessment Scale. The Motor Assessment Scale (MAS) is a performance-based scale that was developed as a means of assessing everyday motor function in patients with stroke. In MAS, task 1 and 3 in the hand movement sub-component assessment were accessed (MAS-Hand), as the two task is the most related component to the tested movement.
Score: The total or maximum scores is 2, and minimum scores is 0. In this scale, the higher the score indicates the better the condition of the subject. The score for a healthy person is 2.
Procedure: The procedure is done according to the standard guideline of this assessment scale."|Motor function of hand function at week 6|Stroke subjects in rehabilitation centre.||Scores||Standard Deviation|Mean
642473|NCT02274675|Primary|Motor Impairment of Wrist and Forearm|"Introduction: Motor impairment of the upper limb is measured by the means of the Fugl-Meyer Assessment Scale that are related to wrist and forearm component. The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index.
Scores: With the component of upper extremity (max 4 scores), wrist (max 10 scores), passive joint motion (max 8 scores) and joint pain (max 8 scores), the total or maximum scores is the sum of all the component which is 30 and the minimum is 0. The score for a normal person is 30 scores. The higher the score indicates the better the condition of the subject.
Procedure: The procedure is done according to the standard guideline of this assessment scale."|Motor impairment of wrist and forearm at week 6|Stroke subjects in rehabilitation centre.||Scores||Standard Deviation|Mean
642474|NCT02274558|Secondary|Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score Responder Analysis at Week 6|Percentage of AIMS responders (subjects who had at least a 50 percent reduction in AIMS score from baseline)|Week 6|Intent to treat (ITT) analysis set (all subjects in the safety analysis set who have a baseline (Day -1) AIMS dyskinesia total score value and at least one post-randomization AIMS dyskinesia total score value reported during the placebo-controlled treatment period).||Participants|||Count of Participants
642475|NCT02274558|Secondary|Clinical Global Impression of Change - TD (CGI-TD) at Week 6|Clinician's perspective of the participant's overall improvement of TD symptoms over time. The CGI-TD is based on a 7-point scale (range: 1=very much improved to 7=very much worse).|Week 6|Intent to treat (ITT) analysis set (all subjects in the safety analysis set who have a baseline (Day -1) AIMS dyskinesia total score value and at least one post-randomization AIMS dyskinesia total score value reported during the placebo-controlled treatment period).||scores on a scale||Standard Error|Least Squares Mean
642476|NCT02274558|Primary|Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score Change From Baseline at Week 6|Severity of TD symptoms assessed by AIMS dyskinesia total score (sum of items 1 through 7), as assessed by blinded central AIMS video raters. The AIMS Total Dyskinesia Score rates a total of 7 items, rating involuntary movement from 0 (no dyskinesia) to 4 (severe dyskinesia). Items 1 through 7 include facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). The AIMS dyskinesia total score for Items 1-7 ranges from 0 to 28; a higher score reflects increased severity.|Baseline and Week 6|Intent to treat (ITT) analysis set (all subjects in the safety analysis set who have a baseline (Day -1) AIMS dyskinesia total score value and at least one post-randomization AIMS dyskinesia total score value reported during the placebo-controlled treatment period).||scores on a scale||Standard Error|Least Squares Mean
642477|NCT02273908|Other Pre-specified|Number of Patients With Adverse Events||Visit2(week4),Final Visit(Week8 or discontinuation)|Safety Analysis Set; All subjects who received at least one dose of pregabalin. The primary objectives of this study did not include comparison of safety with usual care, consistent with the non-interventional nature of the study. Therefore, adverse events were not collected from the participants in usual care.||participants of related AEs|||Number
642478|NCT02273908|Secondary|Work Productivity and Activity Impairment Scale (WPAI:LBP)|"The WPAI: LBP is a self-administered questionnaire that measures the effect of general health and symptom severity on work productivity and regular activities. Subscale scores include Percent work time missed due to pain (PWP), Percent overall work impairment (PWI), Percent work productivity impairment due to pain (PWPI), Percent overall activity impairment (PAI). Each subscale score is expressed as an impairment percentage (0-100) where higher numbers indicate greater impairment and less productivity. Here, n signifies Number of participants for Baseline.
In this study, the WPAI: LBP will measure the effect of the patient's Chronic Low Back Pain (CLBP) with accompanying lower limb pain (neuropathic component) on work productivity and regular activities."|Final Visit (Week8 or discontinuation)|Full Analysis Set||percentage of time missed||Standard Deviation|Mean
645689|NCT02169453|Primary|Cmax - Maximum Observed Plasma Concentration|Cmax - Maximum observed plasma concentration of levodopa|pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose|||ng/mL||Standard Deviation|Mean
642479|NCT02273908|Secondary|Patient Global Improvement of Change (PGIC)|The PGIC is a subject-rated instrument that measures change in the subject’s overall status on a 7-point scale. Scores range from 1 (very much improved) to 7 (very much worse).|Final Visit (Week8 or discontinuation)|Full Analysis Set||participants|||Number
642480|NCT02273908|Secondary|Clinical Global Impression of Change (CGIC)|The CGIC assessment includes one question (1-7 scale) inquiring about the subject's improvement considering their current disease state.; range from 1 (very much improved) to 7 (very much worse).|Final Visit (Week8 or discontinuation)|Full Analysis Set||participants|||Number
642481|NCT02273908|Secondary|Change From Baseline in Euro Qol 5-Dimensions (EQ-5D-5L)-Visual Analogue Scale -|"The EQ-5D-5L is a copyrighted, subject-completed questionnaire designed to assess health-related quality of life in terms of a single index value or utility score. There are two components to the EQ-5D-5L: A Health State Profile and a Visual Analogue Scale (VAS). Recent guidance suggests that the Health State Profile and VAS should be administered together.
The Visual Analogue Scale (VAS) is designed to rate the subject’s current health state on a scale from 0 to 100 where 0 represents the worst imaginable health state and 100 represents the best imaginable health state."|Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation)|Full Analysis Set||units on a scale||Standard Error|Least Squares Mean
642482|NCT02273908|Secondary|Change From Baseline in Euro Qol 5-Dimensions (EQ-5D-5L)-QOL-Score-|The EQ-5D-5L is a copyrighted, subject-completed questionnaire designed to assess health-related quality of life in terms of a single index value or utility score. The Health State Profile is designed to record the subject’s level of current health for five domains comprising a health profile: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Responses from the five domains are used to calculate a single utility index value.; 1 indicates better health state (no problems); 5 indicates worst health state (eg, “confined to bed”). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile; from 11111 to 55555. Score is transformed and results in a total score range -0.025 to 1.000; higher score indicates a better health state.|Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation)|Full Analysis Set||units on a scale||Standard Error|Least Squares Mean
642483|NCT02273908|Secondary|Change From Baseline in Pain Numeric Rating Scale (Pain NRS - Past Week Recall)|The Pain NRS (past week recall) consists of an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst possible pain). Subjects are asked to describe their average pain during the past week by choosing the appropriate number between 0 and 10.|Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation)|Full Analysis Set||scores on a scale||Standard Error|Least Squares Mean
642484|NCT02273908|Secondary|Change From Baseline in Roland Morris Disability Questionnaire (RMDQ)-Japanese Standardized Score-|The RMDQ is an index of how well patients with low back pain are able to function with regard to daily activities. The score for the index ranges from 0 to 24 with a lower score indicating better function.|Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation)|Full Analysis Set||scores on a scale||Standard Error|Least Squares Mean
642485|NCT02273908|Secondary|Change From Baseline in Roland Morris Disability Questionnaire (RMDQ)-Total Score-|The RMDQ is an index of how well patients with low back pain are able to function with regard to daily activities. The score for the index ranges from 0 to 24 with a lower score indicating better function.|Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation)|Full Analysis Set||scores on a scale||Standard Error|Least Squares Mean
642486|NCT02273908|Primary|Change From Baseline in Pain Related Sleep Interference Scale (PRSIS – Past Week Recall)|The Pain Related Sleep Interference Scale (past week recall) consists of an 11-point rating scale ranging from 0 (pain did not interfere with sleep) to 10 (pain completely interfered with sleep). Change the rating scale from baseline to week 8 in each group. Subjects are to describe how their pain has interfered with their sleep during the past week by choosing the appropriate number between 0 and 10.|Baseline, Final Visit (Week 8)|Full Analysis Set; consisted of subjects who had at least one evaluable observation from any of the patient-reported outcomes, and only evaluable subjects who contributed to the particular outcome were evaluated in each analysis. 'n' signifies number of participants who were evaluable for specified categories at different time points||scores on a scale||Standard Error|Least Squares Mean
642487|NCT02273752|Secondary|Response Rate Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST) Criteria|Response rate will be measured at different time points, e.g. 8, 16, and 24 weeks, and will be summarized as percentage of stable disease, complete remission or partial remission along with 95% confidence interval.|Up to 24 weeks|Trial was closed early due to lack of timely accrual. Because study was not fully enrolled, outcomes were unable to be measured accurately.|||||
642488|NCT02273752|Secondary|Type of Treatments for Stomatitis|Type of treatments for stomatitis will be collection of prescription and non-prescription interventions.|Up to 6 months|Trial was closed early due to lack of timely accrual. Because study was not fully enrolled, outcomes were unable to be measured accurately.|||||
642489|NCT02273752|Secondary|Frequency of Treatments for Stomatitis|Frequency of treatments for stomatitis will be collection of prescription and non-prescription interventions.|Up to 6 months|Trial was closed early due to lack of timely accrual. Because study was not fully enrolled, outcomes were unable to be measured accurately.|||||
642490|NCT02273752|Secondary|Dose Interruptions and Adjustments|Dose interruptions and adjustments will be made on a per subject basis and total for the population.|Up to 6 months|Trial was closed early due to lack of timely accrual. Because study was not fully enrolled, outcomes were unable to be measured accurately.|||||
642491|NCT02273752|Secondary|Percentage of Days on Therapy|Percentage of days on therapy will be calculated using the formula: (expected - actual days)/expected x 100.|Up to 6 months|Trial was closed early due to lack of timely accrual. Because study was not fully enrolled, outcomes were unable to be measured accurately.|||||
642492|NCT02273752|Secondary|Downstream Markers of Mammalian Target of Rapamycin (mTOR) Function Measured in Peripheral Blood Mononuclear Cells|Pharmacodynamics will be evaluated for phosphorylated and non-phosphorylated ribosomal protein S6 kinase, protein kinase B, and eukaryotic translation initiation factor 4E-binding protein 1.|Up to day 15 of course 1|Trial was closed early due to lack of timely accrual. Because study was not fully enrolled, outcomes were unable to be measured accurately.|||||
642569|NCT02268877|Primary|Time to Definitive Diagnosis|The time the patient is placed in room to the time that results of the ultrasound (and/or consultative impression made by radiology or obstetrics and gynecology) are documented in patient chart|24 hours|||minutes||Inter-Quartile Range|Median
642493|NCT02273752|Secondary|Progression Free Survival (PFS)|PFS will be evaluated based on rates of cancer progression and time to progression in the population. Progression will be determined using standard RECIST criteria. The median PFS for this study will be estimated by Kaplan-Meier method along with 95% confidence interval.|6 months|Trial was closed early due to lack of timely accrual. Because study was not fully enrolled, outcomes were unable to be measured accurately.|||||
642494|NCT02273752|Primary|Incidence of Stomatitis|Stomatitis graded rates and severity will be evaluated and recorded per World Health Organization and Common Terminology Criteria for Adverse Events criteria in the study population.|Day 29|Trial was closed early due to lack of timely accrual. Because study was not fully enrolled, outcomes were unable to be measured accurately.|||||
642495|NCT02273323|Secondary|Diastolic Blood Pressure Sitting|Diastolic blood pressure measured while sitting|Before and 90 minutes after test product intake|All participants who received at least one dose of each intervention and completed all study visits||mmHg||Standard Deviation|Least Squares Mean
642496|NCT02273323|Secondary|Systolic Blood Pressure Sitting|Systolic blood pressure measured while sitting|Before and 90 minutes after test product intake|All participants who received at least one dose of each intervention and completed all study visits||mmHg||Standard Deviation|Least Squares Mean
642497|NCT02273323|Secondary|Diastolic Blood Pressure Supine|Diastolic blood pressure measured while lying down|Before and 110 minutes after test product intake|All participants who received at least one dose of each intervention and completed all study visits||mmHg||Standard Deviation|Least Squares Mean
642498|NCT02273323|Secondary|Systolic Blood Pressure Supine|Systolic blood pressure measured while lying down|Before and 110 minutes after test product intake|All participants who received at least one dose of each intervention and completed all study visits||mmHg||Standard Deviation|Least Squares Mean
642499|NCT02273323|Secondary|Endothelium-independent Vasodilation|Endothelium-independent dilation after glyceryl trinitrate defined as maximal percent increase in diameter|2.5 hours after test product intake|All participants who received at least one dose of each intervention and completed all study visits||percentage of change in diameter||95% Confidence Interval|Least Squares Mean
642500|NCT02273323|Primary|Flow Mediated Dilation|"Flow mediated dilation (FMD) of the brachial artery was measured using vascular ultra sound and automated edge detection software:
1 minute baseline scan to measure the baseline diameter of artery
5 minutes of forearm occlusion at 250±30 mmHg, below the elbow (2-5 cm from antecubital crease)
4 minutes FMD scan, which started immediately after release of occlusion Percentage FMD was calculated as the maximum increase in diameter after cuff release relative to the baseline diameter"|Before and 2 hours after test product intake|All participants who received at least one dose of each intervention and completed all study visits||percentage of change in diameter||Standard Deviation|Least Squares Mean
642501|NCT02273310|Secondary|Acceptability of Intervention|Families in the FTC group rated acceptability of participating in the intervention workshop. This measure was completed at the workshop (between baseline and 6 month assessments). This measure utilized a 5-point Likert-type scale (with the possible range of scores as 1-5), with higher scores indicating more positive feedback. Individual item scores are presented here. Participant results indicated a range of scores from from 2-5.|post intervention|||units on a scale||Standard Deviation|Mean
642502|NCT02273310|Secondary|Number of Accommodations Provided to Families by Schools|Number of Accommodations Provided to Families by Schools As reported by caregivers|6 months|||Number of Accommodations||Standard Deviation|Mean
642503|NCT02273310|Secondary|School Functioning-Absences|School Absences reported by caregivers, Caregivers reported absences categorically (0-7 days = 1, 7-14 days = 2, etc). Higher numbers indicate more absences.|6 months|||Weeks (1 week = 7 days)||Standard Deviation|Mean
642504|NCT02273310|Primary|Child-Reported Health Related Quality of Life-School Functioning Subscale|Assessed using the Pediatric Quality of Life Inventory, Scores range from 0-100 with higher scores indicating better quality of life.|6 months|||units on a scale||Standard Deviation|Mean
642505|NCT02273167|Secondary|Polyp Detection Rate (Overall Colon)|Comparison of the number of patients with at least one polyp detected in the overall colon when NER1006 is used for bowel cleansing versus number detected when MOVIPREP is used. PDR defined as the number of patients with at least one polyp in the overall colon.|Up to 2 days (from day of first dosing to day of colonoscopy)|The overall number of participants analysed is based on the modified full analysis set. This included all randomized patients except those patients who (i) were randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug (n=822).||Participants|||Number
642506|NCT02273167|Secondary|Polyp Detection Rate (Colon Ascendens)|Comparison of the number of patients with at least one polyp detected in the colon ascendens when NER1006 is used for bowel cleansing versus number detected when MOVIPREP is used. Polyp detection rate (PDR) defined as the number of patients with at least one polyp in the colon ascendens.|Up to 2 days (from day of first dosing to day of colonoscopy)|The overall number of participants analyzed is based on the modified full analysis set. This included all randomized patients except those patients who (i) were randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug (n=822).||Participants|||Number
642507|NCT02273167|Secondary|Adenoma Detection Rate (Overall Colon)|Comparison of the number of patients with at least one adenoma detected in the overall colon when NER1006 is used for bowel cleansing versus number detected when MOVIPREP is used. ADR defined as number of patients with at least one adenoma in the overall colon.|Up to 2 days (from day of first dosing to day of colonoscopy)|The overall number of participants analysed is based on the modified full analysis set. This included all randomized patients except those patients who (i) were randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug (n=822).||Participants|||Number
642508|NCT02273167|Secondary|Adenoma Detection Rate (Colon Ascendens)|Comparison of the number of patients with at least one adenoma detected in the colon ascendens when NER1006 is used for bowel cleansing versus MOVIPREP. Adenoma detection rate (ADR) defined as the number of patients with at least one adenoma in the colon ascendens.|Up to 2 days (from day of first dosing to day of colonoscopy)|The number of participants analyzed is based on the modified full analysis set. This includes all randomized patients with the exception of any patient who (i) was randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug (n=822).||Participants|||Number
642509|NCT02273167|Primary|Number of Participants With Effective Bowel Cleansing (Colon Ascendens)|Comparison of 'Excellent plus good' cleansing of the colon ascendens using NER1006 versus Trisulfate solution. Highly effective bowel cleansing corresponds to scores 3 (Good) or 4 (Excellent) of the HCS. Adequate plus failure bowel cleansing corresponds to score 0-2.|Up to 2 days (from day of first dosing to day of colonoscopy)|The overall number of participants analyzed is based on the modified full analysis set. This included all randomized patients except those patients who (i) were randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug (n=822).||Participants|||Number
642510|NCT02273167|Primary|Number of Participants With Effective Bowel Cleansing (Overall Colon)|The overall quality of bowel cleansing was assessed by a blinded colonoscopist using the Harefield Cleansing Scale (HCS). Comparison of overall success of cleansing with NER1006 versus MOVIPREP was evaluated using a non-inferiority study design. A final grading of A, B, C or D was assigned automatically according to the HCS, where grades of A and B were classified as successful (i.e., all mucosa could be visualized) and C and D were classified as unsuccessful.|Up to 2 days (from day of first dosing to day of colonoscopy)|The overall number of participants analyzed is based on the modified full analysis set. This included all randomized patients, except those patients who (i) was randomized but subsequently failed to meet entry criteria (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug (n=822).||Participants|||Number
642511|NCT02273141|Secondary|Polyp Detection Rate (Overall Colon)|Comparison of the number of patients with at least one polyp detected in the overall colon when NER1006 is used for bowel cleansing versus SP+MS. Polyp detection rate defined as the number of patients with at least one polyp in the colon ascendens.|One day (from day of first dosing to day of colonoscopy)|The overall number of participants analyzed is based on the modified full analysis set. This included all randomized patients except those patients who (i) were randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug (n=501).||Participants|||Number
642512|NCT02273141|Secondary|Polyp Detection Rate (Colon Ascendens)|Comparison of the number of patients with at least one polyp detected in the colon ascendens when NER1006 is used for bowel cleansing versus SP+MS. Polyp detection rate (PDR) defined as the number of patients with at least one polyp in the colon ascendens.|One day (from day of first dosing to day of colonoscopy)|The overall number of participants analyzed is based on the modified full analysis set. This included all randomized patients with the exception of any patient who was randomized but subsequently failed to meet entry criteria and in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug (n=501).||Participants|||Number
642513|NCT02273141|Secondary|Adenoma Detection Rate (Overall Colon)|Comparison of the number of patients with at least one adenoma detected in the overall colon when NER1006 is used for bowel cleansing versus SP+MS. Adenoma detection rate defined as the number of patients with at least one adenoma in the overall colon.|One day (from day of first dosing to day of colonoscopy)|The overall number of participants analyzed was based on the modified full analysis set. This included all randomized patients with the exception of any patient who was randomized but subsequently failed to meet entry criteria and in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug (n=501).||Participants|||Number
642514|NCT02273141|Secondary|Adenoma Detection Rate (Colon Ascendens)|Comparison of the number of patients with at least one adenoma detected in the colon ascendens when NER1006 is used for bowel cleansing versus SP+MS. Adenoma detection rate (ADR) defined as the number of patients with at least one adenoma in the colon ascendens.|One day (from day of first dosing to day of colonoscopy).|The overall number of participants analysed is based on the modified full analysis set. This included all randomized patients with the exception of any patient who was randomized but subsequently failed to meet entry criteria and in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug (n=501).||Participants|||Number
642515|NCT02273141|Primary|Efficacy of Bowel Cleansing (Colon Ascendens)|Comparison of 'Excellent plus good' cleansing of the colon ascendens using NER1006 versus SP+MS. Highly effective bowel cleansing corresponds to scores 3 (Good) or 4 (Excellent) of the HCS. Adequate plus failure bowel cleansing corresponds to scores 0-2.|One day (from day of first dosing to day of colonoscopy)|The overall number of participants analysed is based on the modified full analysis set. This included all randomized patients with the exception of any patient who was randomized but subsequently failed to meet entry criteria and in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug (n=501).||Participants|||Number
642516|NCT02273141|Primary|Efficacy of Bowel Cleansing (Overall Colon)|The overall quality of bowel cleansing was assessed by a blinded colonoscopist using the Harefield Cleansing Scale (HCS). Comparison of overall success of cleansing with NER1006 versus SP+MS was evaluated using a non-inferiority study design. A final grading of A, B, C, or D was assigned automatically according to the HCS, where grades of A and B were classified as successful (i.e. all mucosa could be visualized) and C and D were classified as unsuccessful.|One day (from day of first dosing to colonoscopy)|The overall number of participants analysed is based on the modified full analysis set. This included all randomized patients with the exception of any patient who was randomized but subsequently failed to meet entry criteria and in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug (n=501).||Participants|||Number
642517|NCT02273115|Secondary|Neonatal Outcome: Neonatal Weight||Assessed from birth through discharge, on average 2 days after birth|||grams||Standard Deviation|Mean
642518|NCT02273115|Secondary|Neonatal Outcome: NICU (Neonatal Intensive Care Unit) Admission, 5 Minutes Apgar <7||Assessed from birth through discharge, on average 2 days after birth|||Participants|||Count of Participants
642519|NCT02273115|Secondary|Obstetric Complications||Assessed during induction, labor, delivery, and postpartum. On average, this would be over a 3-7 day time period|||Participants|||Count of Participants
642520|NCT02273115|Secondary|Regional Analgesia|Regional analgesia used during Foley ripening|Assessed during the induction, labor and delivery period, on average occurring between 24-48 hours|||Participants|||Count of Participants
642521|NCT02273115|Secondary|Number of Vaginal Deliveries||Assessed after delivery, on average occurring between 24-48 hours|||Participants|||Count of Participants
642522|NCT02273115|Secondary|Time to Foley Expulsion||0-12 hours|||hours||Inter-Quartile Range|Median
642526|NCT02272725|Secondary|Exercise-Associated Hyponatremia|The count of participants experiencing exercise-associated hyponatremia (defined as < 135 mEq) will be estimated from measured point-of-care blood test at the finish line immediately following completion of a 50 mile ultramarathon. This outcome measure is a biochemical reading, that may not necessarily be a clinical adverse event.|participants will be followed through the duration of a 50 mile ultramarathon, an expected average of 18 hours|||Participants|||Count of Participants
642527|NCT02272725|Secondary|Perceived Exertion|A Borg score of perceived exertion will be measured at the finish line immediately following completion of a 50 mile ultramarathon to measure what affect ibuprofen had on perceived exertion as analgesia may have made the endurance event perceived as less exertional. Scores range from 7 - 20, with higher scores indicative of greater amount of exertion.|participants will be followed through the duration of a 50 mile ultramarathon, an expected average of 18 hours|||units on a scale||Standard Deviation|Mean
642528|NCT02272725|Primary|Acute Kidney Injury|The participants experiencing acute kidney injury (diagnosed by an increase in creatinine of greater or equal to 1.5x that of estimated baseline creatinine from age and weight) will be from measured point-of-care blood test of the finish line immediately following the completion of a 50 mile ultramarathon. This outcome measure is a biochemical reading, that may not necessarily be a clinical adverse event.|participants will be followed through the duration of a 50 mile ultramarathon, an expected average of 18 hours|||Participants|||Count of Participants
642529|NCT02271854|Secondary|Sum of Pain Intensity Differences Over 48 Hours After Initiating Treatment (SPID 48), Derived From POW.|"Sum of pain intensity differences over 48 hours after initiating treatment (SPID 48) (POW) was a secondary outcome.
Sum of pain intensity differences over 48 hours after initiating treatment (SPID 48) for the modified ITT population. SPID 48 derived from Pain on Walking (POW) scores assessed over 48 hours on a 0 (No pain) – 10 (Pain as bad as you can imagine) Numerical Rating Scale. SPID 48 was computed using the trapezoidal rule, i.e. Σ [T(i) – T(i-1)] x [((PID)(i-1) + PID(i))/2] in an obvious notation, where T(i) is nominal time and PID(i), the pain intensity difference at Time i, is the baseline pain intensity (PI) score - PI score at Time i."|48 hours|||units on a scale (NRS)||Standard Deviation|Mean
642530|NCT02271854|Primary|Sum of Pain Intensity Differences Over 24 Hours After Initiating Treatment (SPID 24), Derived From POW.|The primary efficacy outcome was the time-weighted SPID 24 (POW). Sum of pain intensity differences over 24 hours after initiating treatment (SPID 24) for the modified ITT population. SPID 24 derived from Pain on Walking (POW) scores assessed over 24 hours on a 0 (No pain) – 10 (Pain as bad as you can imagine) Numerical Rating Scale. SPID 24 was computed using the trapezoidal rule, i.e. Σ [T(i) – T(i-1)] x [((PID)(i-1) + PID(i))/2] in an obvious notation, where T(i) is nominal time and PID(i), the pain intensity difference at Time i, is the baseline pain intensity (PI) score - PI score at Time i.|24 hours|||units on a scale (NRS)||Standard Deviation|Mean
642531|NCT02271698|Other Pre-specified|Change in Interleukin 6 and 10 Levels|Interleukin levels and the ratio will assess pro and anti inflammatory processes in the patients|Sample immediately prior to incision and at 10-14, 22-26 and 33-39hours after surgery.||||||
642532|NCT02271698|Other Pre-specified|Change in Macrophage Proliferation|Macrophage totals and differentiation will be assessed within patients and between groups.|Samples will be taken immediately pre incision and will be repeated at 33-39hours||||||
642533|NCT02271698|Secondary|Change in Chronic Pain|Brief pain inventory questionnaire will be administered generating a score.|Baseline at enrollment, 3 months and 6 months after surgery||||||
642534|NCT02271698|Secondary|Change in Functional Status|Western Ontario and McMaster Universities Osteoarthritis Index Questionaire generates a score.|30 day, 3 and 6 months following surgery||||||
642535|NCT02271698|Primary|Change in Opioid Consumption|mg of morphine equivalents|6, 12, 18, 24, 36 hours after surgery|Participants who completed pain score at specified time-points.||mg of morphine equivalents||Standard Deviation|Mean
642536|NCT02271698|Primary|Change in Visual Analogue Pain Score|Pain scores at rest and with activity using a verbal rating scales (VRS) of 0-10, where “0” represents no pain and “10” represents worst pain ever.|6, 12, 18, 24, 36 hours after surgery|Participants who completed pain score at specified time-points.||units on a scale||Standard Deviation|Mean
642537|NCT02271529|Primary|Mean Percent Change in Stent Length Upon Deployment||Immediately following completion of the stent placement procedure|There were 63 implanted stents, an assessment of stent length change was not available for 2 stents.||percentage of change in stent length|Participants|Standard Deviation|Mean
642538|NCT02271477|Secondary|Time of Procedures|Time employed to execute all procedure from the start of the study till 30 minutes after the end of the procedure|From time 0 to 30 minutes after spinal anesthesia|||minutes||Standard Deviation|Mean
642539|NCT02271477|Secondary|Percentage of Participants Administered Vasoactive Drug|"Total amount of vasoactive drug administered for each group; for vasoactive drug we intended the use both of atropine than vascular amine"|30 minutes after spinal anesthesia|||percentage of participants|||Number
642540|NCT02271477|Secondary|Total Amount of IV Fluid at the End of the Procedure|To assess if there is a difference between all treatments in the total quantity of fluids amount|30 minutes after spinal anesthesia|||milliliters (mL)||Inter-Quartile Range|Median
642541|NCT02271477|Primary|Rate of Arterial Hypotension|To compare rates of arterial hypotension (previously define by international standard) after spinal anesthesia in patients who have undergone volemic optimization according to Trans-thoracic Echocardiography with patients who have been treated according to the current standard on the intention to treat population.|30 minute after spinal anesthesia|Rate of arterial hypotension after standardized spinal anesthesia||percentage of participants|||Number
642542|NCT02270944|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs)|Safety was assessed as the number of subjects who reported SAEs following a single injection with either liquid or lyophilized GBS trivalent vaccine formulations.|From Day 1 to Day 181 (end of the study)|Analyses were evaluated on the Unsolicited AEs Safety Set (i.e. all subjects in the exposed set who provided information about post vaccination unsolicited AEs). There were 3 subjects in the Liquid GBS trivalent vaccine group who were treated but for whom no safety data were available.||Subjects|||Number
642570|NCT02268864|Secondary|Number of Participants With Viral Relapse|Participants were considered to have had viral relapse if they did not achieve SVR12 and met the following conditions: had HCV RNA <LLOQ (undetectable) at EOT and had HCV RNA >=LLOQ during the follow-up period.|Up to Week 24 after actual EOT|The ITT analysis set is defined as all participants who received at least one dose of simeprevir or daclatasvir.||participants|||Number
642543|NCT02270944|Secondary|Number of Subjects Reporting Any Unsolicited AEs|Safety was assessed as the number of subjects who reported unsolicited AEs following a single injection with either liquid or lyophilized GBS trivalent vaccine formulations.|From Day 1 to Day 181 (end of the study)|Analyses were evaluated on the Unsolicited AEs Safety Set (i.e. all subjects in the exposed set who provided information about post vaccination unsolicited AEs). There were 3 subjects in the Liquid GBS trivalent vaccine group who were treated but for whom no safety data were available.||Subjects|||Number
642544|NCT02270944|Secondary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)|Safety was assessed as the number of subjects who reported solicited local and solicited systemic AEs following a single injection with either liquid or lyophilized GBS trivalent vaccine formulations.|From 6 hours through Day 7 post-vaccination|Analyses were evaluated on the Solicited Safety Set (i.e. all subjects in the exposed set with data on post vaccination local or systemic AEs or other signs of reactogenicity). For 3 treated subjects in the Liquid GBS trivalent vaccine group, no safety data were available and for 4 subjects from both groups, no solicited safety data were reported.||Participants|||Count of Participants
642545|NCT02270944|Primary|Concentration of Serotype Ib GBS IgG Levels in Healthy Non-pregnant Women|To evaluate serotype-specific Ib GBS serum IgG antibody levels (anti-Ib) in healthy non-pregnant women when administered with the liquid GBS trivalent vaccine formulation or the lyophilized GBS trivalent vaccine formulation. Antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). Ib data are not yet available due to testing to be completed with new assay currently in development.|At Day 31 after a single vaccination||12/2019||||
642546|NCT02270944|Primary|Concentration of Serotype III GBS IgG Levels in Healthy Non-pregnant Women|To evaluate serotype-specific III GBS serum IgG antibody levels (anti-III) in healthy non-pregnant women when administered with the liquid GBS trivalent vaccine formulation or the lyophilized GBS trivalent vaccine formulation. Antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL).|At Day 31 after a single vaccination|All subjects in the Full Analysis Set immunogenicity population who received the study vaccine, have no major protocol deviation or other reasons to be excluded as defined prior to unblinding & provided evaluable serum samples both before vaccination and at Day 31 in the protocol required windows.||µg/mL||95% Confidence Interval|Geometric Mean
642547|NCT02270944|Primary|Concentration of Serotype Ia GBS IgG Levels in Healthy Non-pregnant Women|To evaluate serotype-specific Ia GBS serum IgG antibody levels (anti-Ia) in healthy non-pregnant women when administered with the liquid GBS trivalent vaccine formulation or the lyophilized GBS trivalent vaccine formulation. Antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL).|At Day 31 after a single vaccination|All subjects in the Full Analysis Set immunogenicity population who received the study vaccine, have no major protocol deviation or other reasons to be excluded as defined prior to unblinding & provided evaluable serum samples both before vaccination and at Day 31 in the protocol required windows.||µg/mL||95% Confidence Interval|Geometric Mean
642548|NCT02270684|Primary|Knee Osteoarthritis Outcome Score (KOOS)|The KOOS is a validated tool to measure pain and quality of life in patients after TKA|Baseline, 4, 10, 24 weeks|Due to early termination, no evaluable data was collected|||||
642549|NCT02270515|Primary|Estimated KDQOL-36 Scale Score Change for Each 6-month Period and 0-18 Months: Adjusted Random-intercept Models|Quality of life (QOL) was measured using the Kidney Disease Quality of Life-36 (KDQOL-36) survey, a kidney-disease-specific quality of life instrument that assesses five domains: general physical health, mental health, disease burden, disease symptoms, and disease effects. For all KDQOL scales, a higher score indicates better quality of life. All domain scales can range from 0-100.|Baseline (0) to 18 months|All records with data for the KDQOL scale score (dependent variable) and covariates were included in the analysis. Two participants were excluded due to missing data for covariates: dialysis vintage and PCP at baseline. The previous table (adjusted means) shows the number of records with complete data for each visit.||units on a scale||Standard Error|Mean
642550|NCT02270515|Primary|Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Adjusted|"Quality of life (QOL) was measured using the Kidney Disease Quality of Life-36 (KDQOL-36) survey, a kidney-disease-specific quality of life instrument that assesses five domains: general physical health, mental health, disease burden, disease symptoms, and disease effects. For all KDQOL scales, a higher score indicates better quality of life. All domain scales can range from 0-100.
Adjusted means are from random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."|Baseline (0) to 18 months|Ns shown in the table are the number of records at each visit with data for the KDQOL scale score and all covariates. All available records were used to estimate the adjusted means. For all scales, N=173 participants; 2 were excluded due to missing data for covariates: dialysis vintage and PCP at baseline.||units on a scale||Standard Error|Mean
642551|NCT02270515|Primary|Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Unadjusted|Quality of life (QOL) was measured using the Kidney Disease Quality of Life-36 (KDQOL-36) survey, a kidney-disease-specific quality of life instrument that assesses five domains: general physical health, mental health, disease burden, disease symptoms, and disease effects. For all KDQOL scales, a higher score indicates better quality of life. All domain scales can range from 0-100.|Baseline (0) to 18 months|Overall number of participants analyzed are the number who completed the KDQOL at each visit. They differ slightly from the number of participants in the flow chart due to missing KDQOL data. Ns are slightly lower for some scale scores due to missing items (see below).||units on a scale||Standard Deviation|Mean
642552|NCT02269709|Secondary|IVC Pressure|Blood pressure in the IVC, the interior vena cava, was measured from a central line placed for patient care.|Baseline and Follow Up Number 1 (approximately 24 -72 hours later)|Subjects who had undergone the Fontan operation and who had a central line placed. Blood pressure values were obtained from chart review.||mmHg||Standard Error|Mean
642726|NCT02261428|Secondary|Respiratory Rate Immediately After Intervention|Recorded the respiratory rate (breaths per minute), immediately after intervention|Within 2 seconds after catheter withdrawal.|||Βreaths per minute||Standard Deviation|Mean
642553|NCT02269709|Primary|Shear Wave Speed (Liver Stiffness)|ARFI shear wave speed measurements were done on the right lobe of the liver. Measurement units are m/s (meters per second). A total of 8 measurements were performed on each subject at each time point.The 8 values were performed on each subject and averaged.|0-6 months|As shown in the participant flow, data was not captured for follow up time points 1 and 2 for 1 participant. At time point 3 data is only available for 5 participants.||meters per second||Standard Deviation|Mean
642554|NCT02269657|Primary|Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Pressure Mat Parameters|Spinal (coronal and sagittal) and sacro-pelvic parameters were used to evaluate the equivalence between the spinal and pelvic parameters in the two arm positions. Images were only recorded during the wall and clavicle position, not during the natural standing position. Pressure mat parameters were recorded for both arm positions and compared to the natural standing position (arms hanging on either side).|Up to 30 minutes|Each enrolled subject completed bi-planar full spinal x-rays in each of the two positions and pressure mat recording in the two positions and the natural standing position.||percentage of pressure under||Standard Deviation|Mean
642555|NCT02269657|Primary|Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Pelvic Sagittal Plane Parameters|Spinal (coronal and sagittal) and sacro-pelvic parameters were used to evaluate the equivalence between the spinal and pelvic parameters in the two arm positions.|Up to 30 minutes|Each enrolled subject completed bi-planar full spinal x-rays in each of the two positions.||degrees||Standard Deviation|Mean
642556|NCT02269657|Primary|Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Transverse Plane Parameters|Spinal (coronal and sagittal) and sacro-pelvic parameters were used to evaluate the equivalence between the spinal and pelvic parameters in the two arm positions.|Up to 30 minutes|Each enrolled subject completed bi-planar full spinal x-rays in each of the two positions.||degrees||Standard Deviation|Mean
642557|NCT02269657|Primary|Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Frontal Spinal Plane Parameters|Spinal (coronal and sagittal) and sacro-pelvic parameters were used to evaluate the equivalence between the spinal and pelvic parameters in the two arm positions.|Up to 30 minutes|Each enrolled subject completed bi-planar full spinal x-rays in each of the two positions.||degrees||Standard Deviation|Mean
642558|NCT02269657|Primary|Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Spinal Sagittal Plane Parameters|Spinal (coronal and sagittal) and sacro-pelvic parameters were used to evaluate the equivalence between the spinal and pelvic parameters in the two arm positions.|Up to 30 minutes|Each enrolled subject completed bi-planar full spinal x-rays in each of the two positions.||degrees||Standard Deviation|Mean
642559|NCT02269488|Primary|Number of Participants With Solicited Symptoms Experienced From Administration of MEDI3250|"Solicited symptoms experienced from administration of investigational product through 14 days post vaccination by dose number.
Solicited symptoms are events that are considered likely to occur post dosing. For this study, solicited symptoms include Fever ≥ 100.4°F (38.0°C) by any route, Runny/stuffy nose, Sore throat, Cough, Headache, Generalized muscle aches, Decreased activity level (lethargy) or tiredness/weakness, Decreased appetite and Collection of specific solicited symptoms (sore throat, headache, generalized muscle aches) will be omitted when, according to the judgment of the investigator, the subject is too young to reliably report a particular symptom"|14 days post vaccination|||subjects|||Number
642560|NCT02269475|Secondary|the Incidence of Laboratory-confirmed Influenza Infection (Matched Strain, by Strain)|The vaccine efficacy of MEDI3250 compared to placebo against the incidence of laboratory-confirmed influenza infection (matched strain, by strain)|through the end of the influenza surveillance period, up to end Apr (6 months)|Per Protocol Population||Participants|||Number
642561|NCT02269475|Secondary|the Incidence of Laboratory-confirmed Influenza Infection (Any Strain)|The vaccine efficacy of MEDI3250 compared to placebo against the incidence of laboratory-confirmed influenza infection (any strain)|through the end of the influenza surveillance period, up to end Apr (6 months)|||Participants|||Number
642562|NCT02269475|Primary|the Incidence of Laboratory-confirmed Influenza Infection (Matched Strain)|The vaccine efficacy of MEDI3250 compared to placebo against the incidence of laboratory-confirmed influenza infection (matched strain)|through the end of the influenza surveillance period, up to end Apr (6 months)|Per Protocol Population||Participants|||Number
642563|NCT02269098|Other Pre-specified|ED Visits and Hospitalizations|number ED visits and hospitalizations pre and post intervention as self-reported by participants|12 weeks|Self reported Number of ED visits and hospitalizations 3 months prior to and 3 months after the intervention||number of ED visits and hospitlizations|||Number
642564|NCT02269098|Secondary|Hypoglycemia|Hypoglycemia was defined as BG < 70mg/dL. Severe hypoglycemia was defined as BG <40mg/dL and/or requiring assistance to treat. We tracked the total number of hypoglycemia episodes in each group.|4 weeks|we collected data on the total number of hypoglycemia episodes in each group, not the number or participants with hypoglycemia as some participants had more than 1 episode and we wanted to capture those as separate incidents.||total incidents of hypoglycemia|||Number
642565|NCT02269098|Secondary|Blood Glucose < 180mg/dL|Number of patients in each group with BG < 180 mg/dl at 4 weeks from baseline|4 weeks|||participants|||Number
642566|NCT02269098|Primary|Medication Adherence|Score on 8 item Modified Morisky Medication Scale used to assess medication adherence. This scale is a structured and widely used self reported questionnaire used to assess medication taking behaviors.The total score ranges from 0 to 8. A score of 0 is considered “high”adherence, 1 to 2 is considered “medium” adherence, and >2 is considered “low” adherence.|4 weeks|33 patients in the intervention group and 30 in the control group completed the scale at baseline and at 4 weeks and their data was analyzed for this outcome measure.||units on a scale||Standard Deviation|Mean
642567|NCT02269098|Primary|Hemoglobin A1C at 4 Weeks|Hemoglobin A1C at index/baseline visit in the ED and at 4 weeks. A1C was measured using the Bayer A1C-Now+ point of care test system device. If the reading was over 13%, the upper limit of the assay, a venous sample A1C was sent to the hospital lab for analysis.|4 weeks|Participants who completed the full 4 week study period were included in the primary outcomes analysis.||percentage of glycosylated hemoglobin||Standard Deviation|Mean
642568|NCT02268877|Primary|Emergency Department Length-of-Stay|The time the patient is placed in room to the time that the patient is discharged/admitted.|48 hours|||minutes||Inter-Quartile Range|Median
642571|NCT02268864|Secondary|Number of Participants With Viral Breakthrough|Participants were considered to have had viral breakthrough if they had a confirmed greater than (>) 1.0 log10 international units/milliliter (IU/mL) increase in HCV RNA from nadir OR confirmed HCV RNA >100 IU/mL while previously having achieved HCV RNA <LLOQ when on study treatment.|Up to Week 24|The ITT analysis set is defined as all participants who received at least one dose of simeprevir or daclatasvir.||participants|||Number
642572|NCT02268864|Secondary|Percentage of Participants With On-treatment Failure|Participants were considered on-treatment failures if they did not achieve SVR12 and had (confirmed) detectable HCV RNA, ie, <LLOQ detectable or greater than equal to (>=) LLOQ at EOT.|Up to Week 24 after actual EOT|The ITT analysis set is defined as all participants who received at least one dose of simeprevir or daclatasvir.||percentage of participants|||Number
642573|NCT02268864|Secondary|Percentage of Participants With SVR 24 Weeks After End of Study Drug Treatment (SVR 24)|Participants were considered to have reached SVR24, if 24 weeks after the actual EOT, HCV RNA was <LLOQ (detectable or undetectable).|At 24 weeks after actual EOT|The ITT analysis set is defined as all participants who received at least one dose of simeprevir or daclatasvir.||percentage of participants||95% Confidence Interval|Number
642574|NCT02268864|Secondary|Percentage of Participants With Sustained Virologic Response 4 Weeks After End of Study Drug Treatment (SVR4)|Participants were considered to have reached SVR4, if 4 weeks after the actual EOT, HCV RNA was <LLOQ (detectable or undetectable).|At 4 weeks after actual EOT|The ITT analysis set is defined as all participants who received at least one dose of simeprevir or daclatasvir.||percentage of participants||95% Confidence Interval|Number
642575|NCT02268864|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After End of Study Drug Treatment (SVR12)|Participants were considered to have reached SVR12, if 12 weeks after the actual end of treatment (EOT), hepatitis C virus (HCV) ribonucleic acid (RNA) was less than lower limit of quantification (<LLOQ) (detectable or undetectable).|At 12 weeks after end of treatment|The intent-to-treat (ITT) analysis set is defined as all participants who received at least one dose of simeprevir or daclatasvir.||percentage of participants||95% Confidence Interval|Number
642576|NCT02268396|Secondary|Percentage of Correct Advances (±2 or ±4 Actuations) of the Dose Indicator Based on Subject-reported Actuation Count|Percentage of Correct Advances (±2 or ±4 Actuations) of the Dose Indicator Based on Subject-reported Actuation Count|Over the life of the canister/120 puffs - up to 4 weeks|ITT Population||Percentage of correct advances|||Number
642577|NCT02268396|Secondary|Percentage of Devices Where the Dose Indicator Actuation Count is >20 Less Than the Subject-reported Actuation Count (Undercount)|Percentage of devices where the dose indicator actuation count is >20 less than the subject-reported actuation count (undercount)|Over the life of the canister/120 puffs - up to 4 weeks|ITT Population||Percentage|||Number
642578|NCT02268396|Secondary|Percentage of Devices in Agreement Between Laboratory-advanced Does Indicator Actuation and Weight-based Actuation Count at Last Available Visit.|Percentage of devices whose number of actuations counted at the end of the study, using the dose indicator reading, was consistent (±20 actuations) with the number of actuations used as estimated by the change in MDI weight|Over the life of the canister/120 puffs - up to 4 weeks|ITT Population||Percentage|||Number
642579|NCT02268396|Secondary|Percentage of Devices in Agreement Between Laboratory-Advanced Dose Indicator Actuation Count and Subject-Reported Actuation Count at the Last Available Visit|Percentage of devices whose number of actuations counted at the end of the study, using the lab-advanced dose indicator reading, was consistent (±20 actuations) with the number of actuations used as reported by the subject|Over the life of the canister/120 puffs - up to 4 weeks|ITT Population||Percentage of devices|||Number
642580|NCT02268396|Secondary|Percentage of Devices in Agreement Between eCRF-Based Dose Indicator Actuation Count and Weight-Based Actuation Count at the Last Available Visit|Percentage of devices whose number of actuations counted at the end of the study, using the dose indicator reading, was consistent (±20 actuations) with the number of actuations used as estimated by the change in MDI weight|Over the life of the canister/120 puffs - up to 4 weeks|ITT Population||Percentage of Devices|||Number
642581|NCT02268396|Primary|Dose Indicator Actuation Consistency: Percentage of Devices in Agreement Between CRF-Based Dose Indicator Actuation Count|Dose Indicator Actuation Consistency: Percentage of Devices in Agreement Between CRF-Based Dose Indicator Actuation Count and Subject-Reported Actuation Count at the Last Available Visit: ITT Population|Over the life of the canister/120 puffs - up to 4 weeks|ITT Population||Percentage|||Number
642582|NCT02268058|Other Pre-specified|Number of Headaches a Day|the patient family were given a headache diary and instruction to document the number of headaches they have a day for a one week period.|one week|||headaches per day||Full Range|Median
642583|NCT02268058|Other Pre-specified|Headache Intensity Per Day for One Week|The Numerical Rating Scale (NRS) will be used to capture the intensity of the headache experience. The NRS was initially developed for acute post procedural pain and is now a common measure for headache and disease related pain with well established reliability and validity as a self report measure in this age group. Children meeting the inclusion criteria also meet the criteria for self report. The numerical rating scale includes indicators from 0 to 10 with 0 being the ‘no pain’ and 10 being ‘the worst pain ever’. The child when diarizing the headaches will report a pain intensity score for each headache type in their one week headache diary. Study participants and their parent will be given instruction regarding reporting the headache instruction. The headache intensity scores were averaged for the day per participant.|one week|||units on a scale||Full Range|Median
642584|NCT02268058|Secondary|Percentage of Study Participants That Returned to School at One Week Post Concussion|patients/family were asked if the child returned to school one week after their injury|one week|||percentage of participants|||Number
642585|NCT02268058|Primary|Number of Headache Days|study participants completed a one week diary at home stating if they had headaches.|one week|||number of headache days||Full Range|Mean
642586|NCT02267837|Primary|Rate of Orthodontic Anterior Alignment in Millimetres Per Week (mm/wk) by Means of Little's Irregularity Index (LII) for OrthoPulse™ and Non-OrthoPulse™ Treated Patients.||Participants followed for the time it takes to complete orthodontic anterior alignment, an expected average of 30-120 days from the start of orthodontic treatment, depending on the severity of the case.|||millimeters per week (mm/wk)|Participants|Standard Deviation|Mean
642727|NCT02261428|Secondary|Time to Entering Trachea|We count the required time needed to insert catheter into trachea (seconds).|An average of 15 seconds|The 19 interventions with each catheter was used randomly||Sec||Standard Deviation|Mean
642587|NCT02267824|Primary|Rate of Orthodontic Anterior Alignment in Millimetres Per Week (mm/wk) by Means of Little's Irregularity Index (LII) for Extraoral OrthoPulse® PBM and Non-OrthoPulse® PBM Treated Patients.||Participants followed for the time it takes to complete orthodontic anterior alignment, an expected average of 30-120 days from the start of orthodontic treatment, depending on the severity of the case.|||millimeters per week (mm/wk)||Standard Deviation|Mean
642588|NCT02267629|Secondary|Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale.|Patients given YBOCS (Yale Brown Obsessive-Compulsive Scale), a gold standard measure of obsessions and compulsions. For the YBOCS the minimum units are 0 and Maximum units on the total scale are 40. The higher the number on the YBOCS, the more severe the symptoms. Response was defined as at least a 35% reduction on the YBOCS.|Baseline and 4 Weeks|||Participants|||Count of Participants
642589|NCT02267629|Primary|Scores Change in Yale-Brown Obsessive Compulsive Challenge Scale (YBOCCS) Scores From Baseline to 230 Minutes Postinfusion.|Patients self-rated the severity of their obsessions and compulsions using the YBOC Challenge Scale, a 10-item self-report form that assesses Obsessive Compulsive Disorder (OCD) symptoms (i.e., time spent, degree of control, severity) [total score range = 0 – 40 ] over the previous 60 minutes. The higher the number on the YBOCCS, the more severe the symptoms.|Baseline and 230 minutes post infusion|||units on a scale||Standard Deviation|Mean
642590|NCT02267447|Other Pre-specified|Death Due to Causes Other Than CVD||up to 12 years|||deaths|||Number
642591|NCT02267447|Primary|Major Cardiovascular Disease Event|The primary outcome of interest was a major CVD event resulting in hospitalization or sudden death from CVD. Respondents were followed from the survey administration date until the earliest of: incident event, death due to causes other than CVD (defined as a competing risk), loss to follow-up (defined as loss of health care eligibility), or end of study (31 December 2012).|up to 12 years|||Cardiovascular disease event|person-years||Number
642592|NCT02266810|Secondary|Occlusion/Restenosis (Propel Nova Cohort)|"Patency of the FSO was assessed by clinical investigators endoscopically on a 3-point grading scale as follows:
0=Patent
Restenosed/Partially Occluded
Occluded"|Day 30|||percentage of evaluable sinuses|sinus sides|95% Confidence Interval|Number
642593|NCT02266810|Secondary|Inflammation (Propel Nova Cohort)|The degree of inflammation present in the frontal recess/FSO was evaluated by clinical investigators using a 100-mm VAS ranging from 0 defined as no visible inflammation to 100 defined as severe inflammation, involving extensive erythema, edema, or polyposis.|Day 30|||100-mm VAS|sinus sides|Standard Deviation|Mean
642594|NCT02266810|Secondary|Need for Surgical Interventions (Propel Nova Cohort)|"Need for Surgical Interventions by clinical investigators at Day 30
Need for Surgical Interventions by clinical investigators at Day 30.
Need for surgical interventions was prospectively defined as Adhesion/scarring grades of 2 and 3.
Adhesions/Scarring was assessed based on a 4-point scale as follows:
0= No visible granulation/scarring in the FSO
Minimal amount of granulation, scarring or contraction observed but not obstructing the FSO (intervention not warranted)
Moderate amount of obstructive granulation, scarring or contraction present in the FSO (intervention is warranted)
Significant amount of scarring or contraction causing obstruction of the FSO requiring intervention (likely to compromise patency if not removed)"|Day 30|||percentage of evaluable sinuses|sinus sides||Number
642595|NCT02266810|Secondary|Need for Post-operative Interventions (Propel Nova Cohort)|"Need for post-operative interventions by clinical investigators at Day 30.
Need for Post-Operative Intervention is a composite endpoint that includes: surgical intervention required to debride obstructive adhesions or scar tissue formation in the FSO (defined as grade 2 or 3 on the adhesion/scarring scale by investigators), and/or oral steroid intervention warranted to resolve recurrent inflammation and polypoid edema in the frontal recess/FSO (Yes/No response)."|Day 30|||percentage of evaluable sinuses|sinus sides|95% Confidence Interval|Number
642596|NCT02266810|Secondary|Occlusion/Restenosis (Propel Mini Cohort)|"Patency of the FSO was assessed by clinical investigators endoscopically on a 3-point grading scale as follows:
0=Patent
Restenosed/Partially Occluded
Occluded"|Day 30|||percentage of evaluable sinuses|sinus sides|95% Confidence Interval|Number
642597|NCT02266810|Secondary|Inflammation (Propel Mini Cohort)|The degree of inflammation present in the frontal recess/FSO was evaluated by clinical investigators using a 100-mm VAS ranging from 0 defined as no visible inflammation to 100 defined as severe inflammation, involving extensive erythema, edema, or polyposis.|Day 30|||100-mm VAS|sinus sides|Standard Deviation|Mean
642598|NCT02266810|Secondary|Need for Surgical Interventions (Propel Mini Cohort)|"Need for Surgical Interventions by clinical investigators at Day 30.
Need for surgical interventions was prospectively defined as Adhesion/scarring grades of 2 and 3.
Adhesions/Scarring was assessed based on a 4-point scale as follows:
0= No visible granulation/scarring in the FSO
Minimal amount of granulation, scarring or contraction observed but not obstructing the FSO (intervention not warranted)
Moderate amount of obstructive granulation, scarring or contraction present in the FSO (intervention is warranted)
Significant amount of scarring or contraction causing obstruction of the FSO requiring intervention (likely to compromise patency if not removed)"|Day 30|||percentage of evaluable sinuses|sinus sides||Number
642599|NCT02266810|Secondary|Need for Post-operative Interventions (Propel Mini Cohort)|"Need for post-operative interventions by clinical investigators at Day 30
Need for Post-Operative Intervention is a composite endpoint that includes: surgical intervention required to debride obstructive adhesions or scar tissue formation in the FSO (defined as grade 2 or 3 on the adhesion/scarring scale), and/or oral steroid intervention warranted to resolve recurrent inflammation and polypoid edema in the frontal recess/FSO (Yes/No response)."|Day 30|||percentage of evaluable sinuses|sinus sides|95% Confidence Interval|Number
642600|NCT02266810|Primary|Percent of Sinuses That Require Post-operative Interventions (Propel Nova Cohort)|"The reduction in need for post-operative interventions at Day 30, as determined by an independent blinded sinus surgeon based on video-endoscopy reviews.
Need for Post-Operative Intervention is a composite endpoint that includes: surgical intervention required to debride obstructive adhesions or scar tissue formation in the Frontal sinus opening(defined as grade 2 or 3 on the adhesion/scarring scale), and/or oral steroid intervention warranted to resolve recurrent inflammation and polypoid edema in the frontal recess/FSO (Yes/No response)."|Day 30|Of the 80 patients who had their endoscopy recorded at day 30 for grading by independent reviewer; 19 patients could not be included in the test due to missing data. Data were considered missing if the independent reviewer could not grade a video on one or both treatment sinus sides.||percentage sinus requiring intervention||95% Confidence Interval|Number
642601|NCT02266810|Primary|Percent of Sinuses That Require Post-operative Interventions (Propel Mini Cohort)|"The reduction in need for post-operative interventions at Day 30, as determined by an independent blinded sinus surgeon based on video-endoscopy reviews.
Need for Post-Operative Intervention is a composite endpoint that includes: surgical intervention required to debride obstructive adhesions or scar tissue formation in the Frontal sinus opening(defined as grade 2 or 3 on the adhesion/scarring scale), and/or oral steroid intervention warranted to resolve recurrent inflammation and polypoid edema in the frontal recess/FSO (Yes/No response)."|Day 30|ITT population||percent sinuses requiring intervention||95% Confidence Interval|Number
642602|NCT02266797|Secondary|Examine Whether Intravenous Steroids Affect the Outcomes of Surgery, for Example, Fusion Rates.|The outcomes of surgery will be examined through the 1 year post-operative appointment.|12 months|Data not available due to premature halting of study|||||
642603|NCT02266797|Secondary|Examine the Impact of Dexamethasone on Radicular Pain.|This will be quantified by the NDI questionnaire and VAS questionnaire for neck pain and arm pain.|12 months|Data not available due to premature halting of study|||||
642604|NCT02266797|Secondary|Examine the Impact of Dexamethasone on the Development of Postoperative Nausea.|This will be quantified by the visual analogue scale (VAS) questionnaire for nausea and measuring the number of vomiting episodes following surgery.|Immediate post-operatively|Data not available due to premature halting of study|||||
642605|NCT02266797|Secondary|The Efficacy of Intravenous Steroids on Aspiration Rates of Patients Undergoing Anterior Cervical Spine Surgery.|Aspiration rates will be evaluated by the percentage of patients in each group with post-operative aspiration.|12 months|Data not available due to premature halting of study|||||
642606|NCT02266797|Primary|The Correlation Between Radiographic Data and the Extent of Dysphagia in Patients.|Soft-tissue swelling will be measured by the anterior cervical soft-tissue shadow width on lateral cervical radiographs. The extent of dysphagia will be evaluated by the dysphagia questionnaires, the swallow evaluation, and the VFSS, if necessary.|12 months|Data not available due to premature halting of study|||||
642607|NCT02266797|Primary|Intravenous Corticosteroids Effect on Post-operative Dysphagia|The severity of dysphagia will be evaluated by dysphagia questionnaires and a two week postoperative swallow evaluation by a licensed swallowing expert. If recommended by the swallow evaluation, a videofluoroscopic swallow study (VFSS) will be performed to further evaluate the severity of dysphagia.|12 months|Data not available due to premature halting of study|||||
642608|NCT02266472|Secondary|AUC0-infinity of Metformin in Plasma|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity.|-1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration|PKS||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
642609|NCT02266472|Secondary|AUC0-infinity of Empagliflozin in Plasma|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity.|-1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration|PKS||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
642610|NCT02266472|Primary|Cmax of Metformin in Plasma|Maximum measured concentration of the metformin in plasma|-1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration|PKS||ng/mL||Geometric Coefficient of Variation|Geometric Mean
642611|NCT02266472|Primary|Cmax of Empagliflozin in Plasma|Maximum measured concentration of the empagliflozin in plasma|-1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration|PKS||nmol/L||Geometric Coefficient of Variation|Geometric Mean
642612|NCT02266472|Primary|AUC0-tz of Metformin in Plasma|Area under the concentration-time curve of metformin in plasma over the time interval from 0 to the time of the last quantifiable concentration (AUC0-tz)|-1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration|PKS||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
642613|NCT02266472|Primary|AUC0-tz of Empagliflozin in Plasma|Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 to the time of the last quantifiable concentration (AUC0-tz)|-1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration|Pharmacokinetic set (PKS) included all treated subjects that provided at least 1 observation for at least 1 primary endpoint without important protocol violations with respect to the statistical evaluation of the pharmacokinetic endpoints.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
642614|NCT02266381|Secondary|Change in Hemoglobin Concentration|Change in hemoglobin concentration is assessed by comparing the preoperative hemoglobin level with 24-hour postoperative hemoglobin level.|within 24 hours after MPCNL|||g/L||Standard Deviation|Mean
642615|NCT02266381|Secondary|Operation Time|Operation time is defined as the time from puncture to the placement of the nephrostomy tube.|intraoperatively|||min||Standard Deviation|Mean
642616|NCT02266381|Secondary|Perioperative Complications|Complication is defined as any adverse event occurred intraoperatively or ≤ 30 days postoperatively. Complications included fever, systemic Inflammatory Response Syndrome, septic shock, extravasations, bleeding necessitating transfusion, and sever bleeding necessitating selective renal artery embolization.|intraoperatively or ≤ 30 days postoperatively|||Participants|||Number
642617|NCT02266381|Primary|Stone Free Rate|Stone-free status is assessed by kidneys-ureter-bladder (KUB) or/ and noncontrast CT at day 1 after MPCNL. A stone-free state is defined as no residual stones of diameter >4 mm.|one day after MPCNL|||Participants|||Number
642618|NCT02266277|Other Pre-specified|Intervention Patients With Self-reported Influenza Vaccinations Documented in Electronic Health Record (EHR)|We calculated the percent of patients who used the portal or IVR to self-report influenza vaccine completion outside of the medical group, measured on April 1, 2015. We used as our denominator all those patients who received portal messages (10,000) and all those who received IVR calls (15,000).|Months 11-16|||Participants|||Count of Participants
642619|NCT02266277|Secondary|Reliant Medical Group (RMG) Patients With Electroinc Health Record (EHR) Documentation of Pneumococcal Vaccine Completion|Using as a denominator those patients identified as being overdue for pneumococcal vaccine at the time of randomization, we calculated frequencies and performed bivariate and multivariate logistic regression analyses, examining the association between randomization group and completion of pneumococcal vaccine. We analyzed portal users and non-portal users separately.|Months 11-16|||Participants|||Count of Participants
642620|NCT02266277|Primary|Reliant Medical Group (RMG) Patients With Electronic Health Record (EHR) Documentation of Influenza Vaccine Completion for 2014/2015 Season|To determine the impact of our interventions on influenza vaccine completion for the 2014-15 influenza season, we calculated frequencies and performed intention-to-treat bivariate analyses of randomized patients (30,000 patients), assessing whether randomization group was associated vaccine completion. Due to differential rates of vaccination at baseline between portal users and non-users, analyses in these groups were conducted separately. We then performed multivariate logistic regression analyses. We created dummy variables for assignment to the portal message arm (among portal users) and for assignment to the Interactive Voice Recognition (IVR) call arm (among both portal users and, separately, among non-portal users). Including these dummy variables and adjusting for demographic and practice-level covariates, we modeled the odds of receiving an influenza vaccine in the 2014-15 influenza season.|Months 11-16|Using computer-generated random number assignments, we selected 20,000 portal users and 10,000 non portal users (total of 30,000 patients) from the eligible population.||Participants|||Count of Participants
642621|NCT02265848|Other Pre-specified|Preferability|At the conclusion of the study, subjects were asked to report which spinal cord stimulation modes they preferred. Subjects were presented with two boxes (1000 Hz. stimulation and Standard stimulation) and asked to check one.|End of treatment visit on visit 4|All study subjects were implanted with Boston Scientific's Precision Plus spinal cord stimulation system for treatment of chronic axial pain.||participants|||Number
642622|NCT02265848|Secondary|Patient's Global Impression of Change (PGIC)|PGIC is a 7-point scale that requires study subjects to rate the severity of their illness or medical condition after a specific treatment. 1: No change, 2: Almost the same, 3: A little better, 4: Somewhat better, 5: Moderately better, 6: Better, 7: A great deal better. Study subjects were asked to report their impression of changes at baseline visit, visit 2 through 4.|Baseline (visit 1), and at each follow up visits (visits 2, 3, and 4)|All study subjects were implanted with Boston Scientific's Precision Plus spinal cord stimulation system for treatment of chronic axial pain.||units on a scale||Full Range|Mean
642623|NCT02265848|Secondary|Oswestry Disability Index Questionnaire (ODI).|ODI is a outcome metrics that is design to assess the severity of disability based on 10 activity categories. ODI is based on 0 to 100% scale, where larger percentage implies worse disability. (There are 5 categories: 0-20%: Minimal disability, 21-40%: Moderate disability, 41-60%: Severe disability, 61-80%: Crippled. 81-100%: Either bed bound or exaggerating symptoms). ODI were measured at baseline (visit1), and at each follow ups visits at visit 2, 3 and 4. Visit 2 and 4 captured post treatment (either 1000 Hz or standard stimulation depending on the randomization) results, and visit 3 captured NPRS after the wash off from the spinal cord stimulation.|Baseline (visit 1), and at each follow up visits (visits 2, 3, and 4)|All study subjects were implanted with Boston Scientific's Precision Plus spinal cord stimulation system for treatment of chronic axial pain.||units on a scale||Full Range|Mean
642624|NCT02265848|Primary|Numeric Pain Rating Scale (NPRS)|Digital pain rating system that scores patient's subjective pain rating from 0 to 10; with greater number indicating progressively worsening pain. NPRS were measured at baseline (visit1), and at each follow ups visits at visit 2, 3 and 4. Visit 2 and 4 captured post treatment (either 1000 Hz or standard stimulation depending on the randomization) results, and visit 3 captured NPRS after the wash off from the spinal cord stimulation.|Baseline (visit 1), and at each follow up visits (visits 2, 3, and 4)|All study subjects were implanted with Boston Scientific's Precision Plus spinal cord stimulation system for treatment of chronic axial pain.||units on a scale||Full Range|Mean
642625|NCT02265783|Primary|"Report the Time Until the Device Posts Sensor Off After the Sensor is Removed"|A series of sensor-off events were collected from subjects in the study using marketed, off-the-shelf sensors. Each event was marked as pass if event duration (Timeend – Timestart) was less than or equal to 60 seconds; otherwise, the event was marked as greater than or equal to 60 seconds. The acceptance criteria is if 90% of the time the product posts Sensor Off, or any equal or higher priority alarm, within 60 seconds after sensor is removed.|1 minute per event, multiple events per subject. Total duration up to 1 hour|20 subjects participated. There were errors with the data collection device for one subject and the data was unusable.||Percent||95% Confidence Interval|Mean
642626|NCT02265237|Secondary|Percentage of Participants in Arms A, B and C With Post-treatment Relapse|Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants with HCV RNA levels < LLOQ at the end of treatment.|From the end of treatment through 12 weeks after the last dose of study drug|All participants who received at least 1 dose of study drug (ITT population) with at least one post-treatment HCV RNA value, completed treatment, and had HCV RNA <LLOQ at the final treatment visit.||percentage of participants||95% Confidence Interval|Number
642627|NCT02265237|Secondary|Percentage of Participants in Arms A, B and C With On-treatment Virologic Failure|On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; or all on-treatment values of HCV RNA >= LLOQ with at least 6 weeks of treatment.|Up to Treatment Week 24 (end of treatment) or premature discontinuation from treatment|All participants who received at least 1 dose of study drug (ITT population).||percentage of participants||95% Confidence Interval|Number
642628|NCT02265237|Secondary|Percentage of Participants With SVR12 in Participants Receiving 16 Weeks (Arm B) of Treatment Compared to Participants Receiving 24 Weeks of Treatment (Arm C)|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of study drug|All participants who received at least 1 dose of study drug (ITT population); participants with missing data after backwards imputation were imputed as nonresponders.||percentage of participants|||Number
642728|NCT02261428|Primary|Number of Attempts Before Entering Trachea|We count the required attempts to insert catheter into trachea (number of attempts)|An average of 15 seconds|||Attempts||Standard Deviation|Mean
642629|NCT02265237|Secondary|Percentage of Participants With SVR12 in Participants Receiving 12 Weeks (Arm A) of Treatment Compared to Participants Receiving 16 Weeks of Treatment (Arm B)|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of study drug|All participants who received at least 1 dose of study drug (ITT population); participants with missing data after backwards imputation were imputed as nonresponders.||percentage of participants|||Number
642630|NCT02265237|Primary|Percentage of Participants in Arms A, B and C With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (<LLOQ) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of study drug|Intent-to-treat (ITT) population: all participants who received at least 1 dose of study drug; participants with missing data after backwards imputation were imputed as nonresponders.||percentage of participants||97.5% Confidence Interval|Number
642631|NCT02264977|Secondary|Number of Participants With 1 Month Device Related Endoleaks Assessed by an Independent Core Lab|Device-related endoleaks are defined as the presence of contrast within the aneurysm sac originating from the junction between any Branched TAG® Device component and the landing zone (endoleak type IA or IB) OR the junction between the Aortic Component and either the Side Branch Component or the Aortic Extender (type III endoleak).|1 month post procedure|Two participants not assessed for endoleaks at 1 month.||Participants|||Count of Participants
642632|NCT02264977|Secondary|Number of Participants With 1 Month Side Branch Primary Patency Assessed by an Independent Core Lab||1 month post procedure|One participant not assessed for patency at 1 month.||Participants|||Count of Participants
642633|NCT02264977|Primary|Number of Participants With Primary Procedural Side Branch Patency|The presence of forward flow through the implanted Side Branch Component into the target branch vessel.|At conclusion of the treatment procedure (day 0)|||Participants|||Count of Participants
642634|NCT02264977|Primary|Number of Participants With Successful Study Device Deployment|Absence of deployment failure will be considered a successful deployment. Deployment failure will be considered the failure of any Branched TAG® Device component (Aortic Component, Aortic Extender, or SB Component) to be released from the delivery catheter resulting in a serious adverse event (SAE) due to mechanical failure or use error.|During treatment procedure (day 0)|||Participants|||Count of Participants
642635|NCT02264977|Primary|Number of Participants With Successful Study Device Access|Access to the aneurysm and target landing zone location is obtained via conventional vascular access and endovascular techniques.|During treatment procedure (day 0)|||Participants|||Count of Participants
642636|NCT02264821|Primary|Morphine Consumption|Morphine consumption with PCAIV|30 hours after spinal injection T0|||milligrammes||Inter-Quartile Range|Median
642637|NCT02264821|Secondary|Incidence of Morphine Side Effects: Nausea, Vomiting, Pruritus.|Is there a decrease of the incidence of morphine side effects such as nausea, vomiting, pruritus?|30 hours after spinal injection||||||
642638|NCT02264821|Primary|Duration of Effective Analgesia|T0 until first request of morphine PCAIV|30 hours after spinal injection T0|||minutes||Inter-Quartile Range|Median
642639|NCT02264249|Secondary|Procedure Complications (Decrease in Oxygen Saturation)|The patients will be evaluated for complications namely decrease in oxygen saturation during the procedure (Esophagogastroduodenoscopy and colonoscopy) in three groups.|1 day|||participants|||Number
642640|NCT02264249|Secondary|pH of Gastric Fluid of Different Bowel Preparation Regimens|The pH of gastric fluid for the patients undergoing a combined esophagogastroduodenoscopy and colonoscopy will be measured and compared among the groups taking different bowel preparations.|1 day|||pH||Standard Deviation|Mean
642641|NCT02264249|Primary|Residual Gastric Volumes of Different Bowel Preparation Regimens|The residual gastric volume for the patients undergoing a combined esophagogastroduodenoscopy and colonoscopy will be measured and compared among the groups taking different bowel preparations.|1 day|||mL||Standard Deviation|Mean
642642|NCT02263911|Primary|PK: Maximum Concentration (Cmax) of Baricitinib||Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36, and 48 Hours Post-dose|All randomized participants.||nanogram/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
642643|NCT02263911|Primary|PK: Area Under the Concentration Versus Time Curve From Zero to Last Measurable Concentration (AUC[0-tlast]) of Baricitinib||Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36, and 48 Hours Post-dose|All randomized participants.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
642644|NCT02263911|Primary|Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Baricitinib||Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36, and 48 Hours Post-dose|All randomized participants.||nanogram*hour/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
642645|NCT02263833|Other Pre-specified|Percentage of Participants on ESA Therapy Who Were Switched to Mircera Having a Hemoglobin Concentration in the Range of 10 to 12 g/dL||Up to 4 years||||||
642646|NCT02263833|Other Pre-specified|Percentage of ESA Naïve Participants Having an Increase in Hemoglobin (Hb) Level of at Least 1 g/dL From Baseline and Reaching the Hb Level Greater Than or Equal to (>/=) 11 g/dL Without Red Blood Cell Transfusion||Up to 4 years||||||
642647|NCT02263833|Primary|Percentage of Participants With an Adverse Drug Reaction (ADR)|ADRs were defined as any response to a drug which was noxious and unintended, and which occurred at dose normally used related to the pharmacological properties. It was defined as any AE categorized as “definitely related”,“probably related”, “possibly related”, and “unknown” by investigators. In case that an ADR was not written on local Korean Mircera label, it was classified as “Unexpected”. An AE was defined as any untoward medical occurrence in a participant administered with Mircera and which does not necessarily have a causal relationship with Mircera.|At physician's discretion, up to 4 years|Safety population included all participants who received at least a dose of Mircera and had the safety assessment at least once.||percentage of participants|||Number
642788|NCT02258529|Secondary|Changes in Health-Related Quality of Life|Changes in health-related quality of life was to be reported by participants using the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) questionnaire.||Due to the early termination of the study, data were not available for all participants, and therefore this prespecified analysis was not conducted.|||||
642648|NCT02263833|Primary|Percentage of Participants With an Adverse Event (AE) and a Serious Adverse Event|An AE was defined as any untoward medical occurrence in a participant administered with Mircera and which does not necessarily have a causal relationship with Mircera. A Serious Adverse Event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution. It is any AE that at any dose fulfills at least one of the following criteria: is fatal; is life threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is medically significant or requires intervention to prevent one or other of the outcomes listed above.|At physician's discretion, up to 4 years|Safety population included all participants who received at least a dose of Mircera and had the safety assessment at least once.||percentage of participants|||Number
642649|NCT02263131|Secondary|Percentage of Subjects With a Pre-vaccination (Day 0) HI Antibody Titer < 1:40, and a Minimum Four-fold Rise in Post-vaccination (Day 28) HI Antibody Titer||Day28(+7)||||||
642650|NCT02263131|Secondary|GMR of HI Antibody Titer Before Vaccination and After Vaccination|Geometric Mean Ratio (GMR), as measured by pre-vaccination (Day 0) HI antibody titer and post-vaccination (vaccination + 28 days) HI antibody titer.|Day28(+7)||||||
642651|NCT02263131|Secondary|GMT of HI Antibody Titer Before Vaccination and After Vaccination|Geometric Mean Titer (GMT), as measured by pre-vaccination (Day 0) HI antibody titer and post-vaccination (vaccination + 28 days) HI antibody titer.|Day28(+7)||||||
642652|NCT02263131|Secondary|Physical Examination Finding, Vital Signs||Day28(+7)||||||
642653|NCT02263131|Primary|Percentage of Subjects Achieving Seroconversion and Seroprotection for HI Antibody After Administration of the Study Vaccine|Seroconversion: a pre-vaccination (Day 0) hemagglutination-inhibition (HI) antibody titer < 1:10 and a post-vaccination (last vaccination + Day 28) HI antibody titer ≥ 1: 40 (Case 1), or a pre-vaccination (Day 0) HI antibody titer ≥ 1:10 and a minimum four-fold rise in post-vaccination (last vaccination + Day 28) HI antibody titer (Case 2), * Seroprotection: post-vaccination (Day 28) HI antibody titer ≥ 1:40|up to Day28(+7)|||percentage of participants||95% Confidence Interval|Number
642654|NCT02263131|Primary|Solicited Local & General Adverse Event, Unsolicited Adverse Event|Solicited local reaction: pain, tenderness, redness, swelling Solicited general reactions: fever, nausea/vomiting, diarrhea, headache, fatigue, myalgia|up to Day28(+7)|||percentage of paticipants||95% Confidence Interval|Number
642655|NCT02263118|Secondary|Mean Change in Weight-for-Age Z-score|"We used the World Health Organization Anthro software (http://www.who.int/childgrowth/software/en/) to calculate z-scores for the weight-for-age anthropometric indicator of participants' infants at the beginning and at the end of the project. The software is based on the WHO Child Growth Standards and allowed to compare measurements of infants to the normal growth standards. The Z-score indicates the number of standard deviations away from the mean. The indicator is particularly useful to detect abnormal growth patterns in infants' development. For instance, an infant whose weight falls in the -2 z-score for the weight-for-age anthropometric indicator is underweight. Below -3, the child is severely underweight. Similarly, a child whose weight-for-age is above a +1 z-score may have a growth problem.
We report the mean change of the z-scores for the weight-for-age anthropomorphic indicator of participants' babies."|Baseline at December 2013 and 23 weeks later in May 2014|||z-score||95% Confidence Interval|Mean
642656|NCT02263118|Secondary|Number of Text-messages Exchanged in Virtual Communities|We were interested in the activity of virtual communities in terms of sent text-messages.|December 2013 - May 2014, 23 weeks|"In virtual communities, participants were added to 1 of 3 peer-to-peer groups. They could communicate by sending SMSs to a short-code number. In the hybrid setup, participants were added to 1 of 3 peer-to-peer groups, but in addition received information regarding breastfeeding practices and could communicate with a health professional."||Number of text messages|||Number
642657|NCT02263118|Secondary|Qualitative Nature of Health-related Text-messages|Specifically, we were interested in classifying individual text-messages as social support or health related.|December 2013 - May 2014, 23 weeks|||Number of text messages|Participants||Number
642658|NCT02263118|Primary|Number of Participants With Changes in Knowledge|Specifically, we were interested in: the number of participants who switched from an incorrect to a correct knowledge regarding exclusive breastfeeding during the experiment (learned the message); the number of participants who had a correct knowledge but switched to an incorrect one during the experiment (forgot the message); the number of participants who had an incorrect knowledge and kept it until the end of the experiment (continued to be unaware); the number of participants who had a correct knowledge and kept it until the end of the experiment (remembered the message).|December 2013 - May 2014, 23 weeks|||participants|||Number
642659|NCT02262754|Secondary|Plasma Concentration of Naproxen|Data was calculated by setting concentration values below the LLOQ to zero. The LLOQ was <1000 ng/mL.|Baseline, Week 1, 2, 3, 4|"FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, n signifies participants who were evaluable at the specified time point for each arm."||ng/mL||Standard Deviation|Mean
642660|NCT02262754|Secondary|Plasma Concentration of PF-06372865|Data was calculated by setting concentration values below the lower limit of quantification (LLOQ) to zero. The LLOQ was <0.0100 nanogram per milliliter (ng/mL).|Baseline, Week 1, 2, 3, 4|"FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, n signifies participants who were evaluable at the specified time point for each arm."||ng/mL||Standard Deviation|Mean
642661|NCT02262754|Secondary|Number of Participants With Global Evaluation of Study Medication (GESM) at Week 4|Participants rated their study treatment by GESM questionnaire. It was a qualitative measure of efficacy utilizing a 4-point Likert scale ranging from 1 (poor) to 4 (excellent), where higher score indicated a better overall response to the treatment. Number of participants who reported a particular score had been reported.|Week 4|"FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."||participants|||Number
642662|NCT02262754|Secondary|Patient Global Impression of Change (PGI-C) Score|PGI-C was a participant rated instrument to measure participant's assessment of change in his or her overall status since the previous visit on a 7-point scale; ranging from 1 (very much improved) to 7 (very much worse), where higher scores indicated more worsening.|Week 1, 2, 3, 4|"FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, n signifies participants who were evaluable at the specified time point for each arm."||units on a scale||90% Confidence Interval|Least Squares Mean
642663|NCT02262754|Secondary|Change From Baseline in Participant's Global Assessment (PtGA) of Low Back Pain Score at Week 1, 2, 3 and 4|Participant rated 5-point Likert scale ranging from 0 (no pain) to 4 (worst possible pain) with a higher score indicating greater level of pain.|Baseline, Week 1, 2, 3, 4|"FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, n signifies participants who were evaluable at the specified time point for each arm."||units on a scale||90% Confidence Interval|Least Squares Mean
642664|NCT02262754|Secondary|Chronic Low Back Pain (CLBP) Responder Index Analysis|Participants were successful responders if they had any of the following: >=30 percent reduction in mean daily average LBPI from baseline to particular week; decrease of >=30 percent in participant's global assessment of low back pain (disease activity) from baseline to particular week or no worsening (increase) in RMDQ total score from baseline to particular week.|Week 1, 2, 3, 4|FAS included all participants randomized and who had received at least 1 dose of randomized treatment.||participants|||Number
642665|NCT02262754|Secondary|Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) at Week 2 and 4|This test assesses verbal learning and memory. Participants are given a list of 12 words and asked to repeat as many words as they can recall during 3 separate learning trials. The total recall score ranges from 0 (no memory) to 36 (best memory) while the delayed recall trial score ranges from 0 (no memory) to 12 (best memory); higher scores indicated greater verbal learning and recall.|Baseline, Week 2, Week 4|"FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, n signifies participants who were evaluable at the specified time point for each arm."||units on a scale||Standard Deviation|Mean
642666|NCT02262754|Secondary|Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 4|Each participant assessed his or her own disability due to low back pain using the RMDQ worksheet. The RMDQ total score was calculated as the total number of statements that were checked; the RMDQ total possible scores ranges from 0 to 24, with higher scores indicating greater disability.|Baseline, Week 4|FAS included all participants randomized and who had received at least 1 dose of randomized treatment.||units on a scale||90% Confidence Interval|Mean
642667|NCT02262754|Secondary|Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 1, 2, and 3|Each participant assessed his or her own disability due to low back pain using the RMDQ worksheet. The RMDQ total score was calculated as the total number of statements that were checked; the RMDQ total possible scores ranges from 0 to 24, with higher scores indicating greater disability.|Baseline, Week 1, 2, 3|"FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, n signifies participants who were evaluable at the specified time point for each arm."||units on a scale||Standard Deviation|Mean
642668|NCT02262754|Secondary|Amount of Rescue Medication Used by the Participants|The amount of rescue medication (Acetaminophen [paracetamol]) used was reported. Participants were permitted to use any commercial product of acetaminophen tablet/caplet/capsule.|Week 1, 2, 3, 4|"FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, n signifies participants who were evaluable at the specified time point for each arm."||mg||Standard Deviation|Mean
642669|NCT02262754|Secondary|Number of Days Participants Used the Rescue Medication|The number of days for which the participants used the rescue medication were reported. Participants recorded the usage of acetaminophen rescue medication in the daily diary.|Week 1, 2, 3, 4|"FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, n signifies participants who were evaluable at the specified time point for each arm."||days||Standard Deviation|Mean
642670|NCT02262754|Secondary|Number of Participants Using Rescue Medication|Participants were permitted to use any commercial product (tablet/caplet/capsule) of acetaminophen (paracetamol) 500 mg as a rescue medication. Number of participants who used rescue medication were reported.|Week 1, 2, 3, 4|"FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, n signifies participants who were evaluable at the specified time point for each arm."||participants|||Number
642671|NCT02262754|Secondary|Time to Withdrawal Due to Lack of Efficacy|"Kaplan Meier and Cox Proportional Hazards analyses were to be used to compute the time to withdrawal due to lack of efficacy. Withdrawal due to lack of efficacy was identified from the participant summary case report form (CRF) page and where reason was identified as Insufficient Clinical Response. Time to withdrawal was calculated as Date of withdrawal - Date of Randomization."|Baseline up to Week 4|FAS included all participants randomized and who had received at least 1 dose of randomized treatment.||days||90% Confidence Interval|Median
642672|NCT02262754|Secondary|Number of Participants Withdrawn Due to Lack of Efficacy|Participants withdrew from the study due to lack of efficacy (insufficient clinical response) were reported.|Baseline up to Week 4|FAS included all participants randomized and who had received at least 1 dose of randomized treatment.||participants|||Number
642673|NCT02262754|Secondary|Number of Participants With Sustained Response Rates in Daily Average LBPI NRS Scores at Greater Than or Equal to (>=) 30 Percent and >=50 Percent Reduction From Baseline|Average back pain was assessed with an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Participants described their average low back pain during the past 24 hours by choosing the appropriate number from 0 to 10. Percentage of reduction from baseline in the daily average LBPI NRS score was calculated as: ([daily value - baseline value] divided by baseline value) multiplied by 100. Number of participants with sustained response rates (for a minimum of 4 consecutive days) in the daily average LBPI NRS scores that were at >=30 percent and >=50 percent reduced from baseline were reported.|Baseline up to Week 4|FAS included all participants randomized and who had received at least 1 dose of randomized treatment.||participants|||Number
642789|NCT02258529|Secondary|Overall Survival|Overall survival was defined as the interval from enrollment to death from any cause.||Due to the early termination of the study, efficacy data were not mature for all participants, and therefore the prespecified analyses were not conducted.|||||
642674|NCT02262754|Secondary|Percent Change From Baseline in Daily Low Back Pain Intensity (LBPI) as Measured by an 11-point Numeric Rating Scale (NRS) at Week 1, 2, 3 and 4|Average back pain was assessed with an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Participants described their average low back pain during the past 24 hours by choosing the appropriate number from 0 to 10.|Baseline, Week 1, 2, 3, 4|"FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, n signifies participants who were evaluable at the specified time point for each arm."||percent change||Standard Deviation|Mean
642675|NCT02262754|Secondary|Change From Baseline in Daily Low Back Pain Intensity (LBPI) as Measured by an 11-point Numeric Rating Scale (NRS) at Week 1, 2 3 and 4|Average back pain was assessed with an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Participants described their average low back pain during the past 24 hours by choosing the appropriate number from 0 to 10.|Baseline, Week 1, 2, 3, 4|"FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, n signifies participants who were evaluable at the specified time point for each arm."||units on a scale||90% Confidence Interval|Least Squares Mean
642676|NCT02262754|Primary|Change From End of Treatment Visit in Physician's Withdrawal Checklist (PWC) Score at Follow-up Visit|PWC is a 20 item physician rated interview to measure anxiolytic drug withdrawal-related signs and symptoms. Each individual item score ranges from 0 (not present) to 3 (severe), where higher scores = more affected condition. PWC total score range from 0 (not present) to 60 (severe), where higher score = more affected condition. Change: score at follow-up visit minus score at the end of treatment visit.|End of treatment (Day 30), follow-up (Day 44)|Safety analysis set included all participants who received at least 1 dose of study treatment.||units on a scale||90% Confidence Interval|Least Squares Mean
642677|NCT02262754|Primary|Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)|The C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment [C-CASA]) is an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior. C-SSRS assessed whether participant experienced following: completed suicide =1, suicide attempt =2 (response of “Yes” on “actual attempt”), preparatory acts toward imminent suicidal behavior =3 (“Yes” on “preparatory acts or behavior”), suicidal ideation =4 (“Yes” on “wish to be dead”, “non-specific active suicidal thoughts”, “active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior =7 (“Yes” on “Has participant engaged in non-suicidal self-injurious behavior”).|Screening, Baseline, Week 1, 2, 3, 4|Data was not collected for this outcome measure as per study team’s decision, since it was a semi-structured interview and was difficult to pull accurate scores from it.|||||
642678|NCT02262754|Primary|Number of Participants With Electrocardiogram (ECG) Abnormalities|Participants with abnormal ECG findings were reported. Criteria for potential clinical concern in ECG parameters: maximum (max.) PR interval of >=300 milliseconds (msec), maximum QRS interval >=140 msec, maximum QTCF interval (Fridericia’s Correction) of 450 to <480 msec, 480 to <500 msec and >=500 msec, maximum of >=25 percent (%) increase from baseline (IFB) value of >200 msec and >=50% for baseline value of less than or equal to (<=) 200 msec for PR interval, maximum increase from baseline of >=50% for QRS interval, maximum increase from baseline of >=30 msec to <60 msec and maximum increase from baseline of >60 msec in QTCF interval (Fridericia’s Correction).|Baseline up to Follow-up (44 days)|"Safety analysis set included all participants who received at least 1 dose of study treatment. Here, n signifies the number of participants evaluable for the specific category."||participants|||Number
642679|NCT02262754|Primary|Number of Participants With Vital Sign Abnormalities|Participants who met the criteria for abnormal findings in vital signs data were reported. Criteria for abnormalities in vital signs: supine systolic blood pressure (SBP) <90 millimeter of mercury (mmHg), supine diastolic BP (DBP) <50 mmHg, supine pulse rate <40 beats per minute (bpm) or >120 bpm. Maximum increase or decrease from baseline in supine SBP >=30 mmHg and maximum increase or decrease from baseline in supine DBP >=20 mmHg.|Baseline up to Follow-up (44 days)|Safety analysis set included all participants who received at least 1 dose of study treatment.||participants|||Number
642680|NCT02262754|Primary|Number of Participants With Laboratory Abnormalities|Abnormality criteria included: hemoglobin, hematocrit and red blood cells (RBCs) (less than [<] 0.8*lower limit of normal [LLN]); white blood cells (WBC) (<0.6*LLN, greater than [>] 1.5*upper limit of normal [ULN]); MCV, MCH, MCHC (<0.9*LLN, >1.1*ULN); platelets (<0.5*LLN>, >1.75*ULN); neutrophils, lymphocytes(<0.8*LLN, >1.2*ULN); eosinophils, basophils, monocytes (>1.2*ULN); total bilirubin (>1.5*ULN); aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase (>3*ULN); total protein, albumin (<0.8*LLN, >1.2*ULN); creatinine, blood urea nitrogen (>1.3*ULN); glucose (<0.6*LLN, >1.5*ULN); uric acid (>1.2*ULN); sodium, potassium, chloride, calcium, bicarbonate (<0.9*LLN, >1.1*ULN); urine pH (<4.5, >8); qualitative urine glucose, ketones, protein, blood values (greater than or equal to [>=] 1) in urine dipstick test; urine RBC, WBC (>=20); hyaline casts (>1), bacteria (>20).|Baseline up to 28 days after the last dose of study treatment (Day 56)|"Safety analysis set included all participants who received at least 1 dose of study treatment. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."||participants|||Number
642681|NCT02262754|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. The SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.|Baseline up to 28 days after the last dose of study treatment (Day 56)|Safety analysis set included all participants who received at least 1 dose of study treatment.||participants|||Number
642790|NCT02258529|Secondary|Progression-Free Survival|Progression-free survival (PFS) was defined as the interval from the start of idelalisib treatment to the earlier of the first documentation of disease progression or death from any cause.||Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.|||||
642682|NCT02262754|Primary|Change From Baseline in Daily Low Back Pain Intensity (LBPI) Score as Measured by an 11-point Numeric Rating Scale (NRS) at Week 4|Daily average low back pain was assessed on an 11-point numeric rating scale (NRS). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate higher pain. Baseline value was calculated as the mean of the scores over the last 7 days in the placebo run-in period, prior to randomization. Post-baseline weekly scores were calculated based on the mean of the scores over the 7 days prior to and including the day at the end of the corresponding week.|Baseline, Week 4|FAS included all participants randomized and who had received at least 1 dose of randomized treatment.||units on a scale||90% Confidence Interval|Mean
642683|NCT02262728|Secondary|Percentage of Participants With SVR12 Who Maintain to Have HCV RNA <LLOQ Until the End of 5 Years Follow up|Percentage of participants with SVR12 who continue to have HCV RNA <LLOQ (15 IU/mL) will be reported after the completion of the follow-up phase.|Week 24 up to Week 276||01/2021||||
642684|NCT02262728|Secondary|Percentage of Participants With Viral Relapse|Viral relapse is defined as participants who do not achieve SVR12, with undetectable HCV RNA at the actual end of study drug treatment and confirmed HCV RNA greater than or equal to (>=) LLOQ (15 IU/mL) at Week 16, 24 or 36.|Week 16, 24 and 36|The ITT analysis set who failed achieving SVR. Since all participants achieved SVR, the number of participants for this endpoint (viral relapse) analysis was zero.|||||
642685|NCT02262728|Secondary|Percentage of Participants With On-treatment Failure|On-treatment failure is defined as participants who do not achieve SVR12 and with confirmed detectable HCV RNA at the actual end of study drug treatment.|Week 12|The intent-to-treat (ITT) analysis set included all enrolled participants who took at least 1 dose of study drug. Here “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.||Percentage of Participants|||Number
642686|NCT02262728|Secondary|Pre-dose (Trough) Concentration (C0h) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)|The C0h is the pre-dose plasma concentration.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, and 24 hours post-dose on Weeks 2 and 8|PK analysis set included all participants who received atleast 1 dose of study drug and had valid pharmacokinetic profile. Here 'n' signifies number of participants analysed for this outcome measure at specific time point.||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
642687|NCT02262728|Secondary|Minimum Plasma Concentration (Cmin) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)|The Cmin is the minimum observed plasma concentration.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, and 24 hours post-dose on Weeks 2 and 8|PK analysis set included all participants who received atleast 1 dose of study drug and had valid pharmacokinetic profile. Here 'n' signifies number of participants analysed for this outcome measure at specific time point.||ng/mL||Standard Deviation|Mean
642688|NCT02262728|Secondary|Maximum Plasma Concentration (Cmax) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)|The Cmax is the maximum observed plasma concentration.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, and 24 hours post-dose on Weeks 2 and 8|Pharmacokinetic (PK) analysis set included all participants who received atleast 1 dose of study drug and had valid pharmacokinetic profile. Here 'n' signifies number of participants analysed for this outcome measure at specific time point.||nanogram per Millilieters (ng/mL)||Standard Deviation|Mean
642689|NCT02262728|Secondary|Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours After Dosing (AUC[0-24]) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)|The AUC(0-24) is area under the plasma concentration-time curve from time 0 to 24 hours after dosing.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, and 24 hours post-dose on Weeks 2 and 8|Pharmacokinetic (PK) analysis set included all participants who received atleast 1 dose of study drug and had valid pharmacokinetic profile. Here 'n' signifies number of participants analysed for this outcome measure at specific time point.||ng.h/mL||Standard Deviation|Mean
642690|NCT02262728|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)|Tmax is the time to reach maximum observed plasma concentration.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, and 24 hours post-dose on Weeks 2 and 8|Pharmacokinetic (PK) analysis set included all participants who received atleast 1 dose of study drug and had valid pharmacokinetic profile. Here 'n' signifies number of participants analysed for this outcome measure at specific time point.||Hours||Full Range|Median
642691|NCT02262728|Secondary|Absolute Values of Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) Levels at Follow-up Week 24 (Week 36)||Follow-up Week 24 (Week 36)|The intent-to-treat (ITT) analysis set included all enrolled participants who took at least 1 dose of study drug. Here, 'n' signifies number of participants evaluable for this outcome measure at specific time point.||Units per Liter (U/L)||Standard Deviation|Mean
642692|NCT02262728|Secondary|Percentage of Participants With HCV NS3/4A Sequence, NS5A and NS5B After End of Treatment in Participants Not Achieving SVR|Sequencing of the HCV nonstructural protein 3/4A (NS3/4A), nonstructural protein 5A (NS5A) and nonstructural protein 5B (NS5B) genes was done to identify pre-existing sequence polymorphisms and characterize emerging HCV viral variants in participants not achieving SVR. All subjects in this study achieved SVR12. Therefore, reasons for not achieving SVR12 are not applicable.|Baseline, Day 3, Week 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and Year 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5 after end of treatment|The ITT analysis set who failed achieving SVR. Since all participants achieved SVR, the number of participants for this endpoint analysis was zero.|||||
642693|NCT02262728|Secondary|Percentage of Participants With SVR 4 Weeks After End of Study Drug Treatment (SVR4) and SVR 24 Weeks After End of Study Drug Treatment (SVR24)|Participants were considered to have achieved SVR4 and SVR24 if the HCV RNA was <LLOQ detectable or undetectable at 4 weeks and 24 weeks respectively after the end of study drug treatment. The LLOQ value was 15 IU/mL.|Week 16 and Week 36|The intent-to-treat (ITT) analysis set included all enrolled participants who took at least 1 dose of study drug. Here , 'n' signifies number of participants evaluable for this outcome measure at specific time point.||Percentage of Participants||95% Confidence Interval|Number
642694|NCT02262728|Secondary|Percentage of Participants With On-Treatment Virologic Response|On-treatment virologic response was determined by HCV RNA results satisfying a specified threshold. The following thresholds were considered at any time point: <LLOQ undetectable, <LLOQ detectable, and <LLOQ undetectable or detectable. The LLOQ value was 15 IU/mL. Very rapid virologic response (vRVR) is undetectable HCV RNA at Week 2 while on treatment and Rapid virologic response (RVR) is undetectable HCV RNA at Week 4 while on treatment.|Week 1, 2, 4, 6, 8, 10, 12|The intent-to-treat (ITT) analysis set included all enrolled participants who took at least 1 dose of study drug. Here, 'n' signifies number of participants evaluable for this outcome measure at specific time point.||Percentage of Participants|||Number
642695|NCT02262728|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After End of Study Drug Treatment (SVR12)|Participants were considered to have achieved SVR12 if the hepatitis C virus ribonucleic acid (HCV RNA) was less than (<) lower limit of quantification (LLOQ; 15 international unit per milliliter [IU/mL]) detectable or undetectable at 12 weeks after the end of study drug treatment.|Week 24|The intent-to-treat (ITT) analysis set included all enrolled participants who took at least 1 dose of study drug.||Percentage of Participants||95% Confidence Interval|Number
642696|NCT02262078|Primary|Change in Pulmonary Capillary Wedge Pressure During Exercise|Pulmonary capillary wedge pressure is a measure of cardiac filling pressure, measured in millimeters of mercury (mmHg)|Baseline, after study drug dosing, approximately 4 minutes after starting exercise|||millimeters of mercury||Standard Deviation|Mean
642697|NCT02262039|Secondary|Mean ETCO2|mean End-tidal carbon dioxide concentration in the expired air|intraoperative|||mmHg||Standard Deviation|Mean
642698|NCT02262039|Secondary|Subjective Pain Score|Pain assessment via Visual Analogue Scale (VAS). Patients indicate pain on a continuous line which converts to a measured value in centimeters (cm). (Range: 0.0 and 10.0) - A score of 0 indicates no pain.|12 hours post-op|||units on a scale||Standard Deviation|Mean
642699|NCT02262039|Secondary|Subjective Pain Score|Pain assessment via Visual Analogue Scale (VAS). Patients indicate pain on a continuous line which converts to a measured value in centimeters (cm). (Range: 0.0 and 10.0)- A score of 0 indicates no pain.|6 hours post-op|||units on a scale||Standard Deviation|Mean
642700|NCT02262039|Secondary|Subjective Pain Score|Pain assessment via Visual Analogue Scale (VAS). Patients indicate pain on a continuous line which converts to a measured value in centimeters (cm). (Range: 0.0 and 10.0) - A score of 0 indicates no pain.|1 hour post-op|||units on a scale||Standard Deviation|Mean
642701|NCT02262039|Primary|Narcotic Use (mg)|Total Morphine Equivalent - mean in mg|Operative and Post-operative (until time of discharge, typically 2-4 days)|||mg||Standard Deviation|Mean
642702|NCT02262039|Primary|Narcotic Use (mg)|Total Morphine Equivalents - mean in mg|Post-operative (until time of discharge, typically 2-4 days)|||mg||Standard Deviation|Mean
642703|NCT02262039|Primary|Narcotic Use (mg)|Total Morphine Equivalents - mean in mg|Intra-Operative on day of surgery|||mg||Standard Deviation|Mean
642704|NCT02261948|Secondary|Change in DLCO (Diffusion Lung CO)|Levosimendan induced changes on DLCO ( Diffusion Lung CO). DLCO is measured by the single breath-constant expiratory flow technique (Sensor Medics 2200, Yorba Linda, CA) and we calculate also the DLCO adjusted for hemoglobin. Dilution of CH4 is used to measure alveolar volume.|48 hours|||ml/mmHg/min||Standard Deviation|Mean
642705|NCT02261948|Secondary|Changes in VE/VCO2|Levosimendan induced changes on VE/VCO2 (VE: Expired Volume - VCO2: carbon dioxide production) relationship|48 hours|||VE/VCO2 Slope||Standard Deviation|Mean
642706|NCT02261948|Primary|Change in Peak VO2 (Oxygen Consumption )|Primary endpoints: Levosimendan induced changes in peak VO2 (Oxygen consumption )|48 hours|||ml/kg/min||Standard Deviation|Mean
642707|NCT02261818|Primary|Depression With PHQ-9|PHQ-9 will be used to assess depression. The maximum score is 27. The scale is interpreted as follows: 0-4 no depression, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.|at 8 weeks|Patient participants||units on a scale||Standard Deviation|Mean
642708|NCT02261493|Secondary|Time to Retreatment Eligibility|Time to retreatment eligibility is defined as the number of days from treatment cycle 1 injection to the return to an Investigator FWS rating of moderate or severe at maximum eyebrow elevation. The FWS is a 4-grade scale, where 0=none, 1=mild, 2=moderate, and 3=severe. Only subjects who achieved a ≥ 2-grade improvement on both the Investigator and subject FWS ratings at maximum eyebrow elevation on Day 30 are included in the analysis.|12 Months|Intent-to-Treat: all randomized subjects who achieved a ≥ 2-grade improvement on both the Investigator and subject FWS ratings at maximum eyebrow elevation||Days||Standard Deviation|Median
642709|NCT02261493|Secondary|Percentage of Subjects With a ≥3-Point Improvement From Baseline on Item 4 of the 11-Point Facial Line Outcomes (FLO-11) Questionnaire©|"The FLO-11 assess the subject's psychological and appearance-related impacts associated with facial lines. Item 4 is I look older than my actual age because of my facial lines with a range of possible scores from 0 = not at all to 10 = very much. Only subjects with baseline scores ≥ 3 are included in the analysis."|Baseline, Day 30|Intent-to-Treat: all randomized subjects with baseline scores ≥ 3 on Item 4 of the FLO-11||Percentage of Subjects||95% Confidence Interval|Number
642710|NCT02261493|Secondary|Percentage of Subjects With ≥20-Point Improvement From Baseline on the Impact Domain of the FLSQ Among Subjects With Baseline Score ≥ 20 Points|The FLSQ consists of 13 questions that assess subject satisfaction and appearance-related impacts associated with facial lines. The Impact Domain measures the subject’s appearance-related and emotional impacts of treatment and is composed of 5 questions with a possible range of scores from 0 (worst) to 100 (best), using a transformed scale. Only subjects with baseline scores ≥ 20 are included in the analysis.|Baseline, Day 30|Intent-to-Treat: all randomized subjects with baseline scores ≥ 20 on the Impact Domain of the FLSQ||Percentage of Subjects||95% Confidence Interval|Number
642711|NCT02261493|Secondary|Percentage of Subjects Reporting Mostly Satisfied or Very Satisfied on the 5-Point Facial Line Satisfaction Questionnaire (FLSQ) Item 5|"The FLSQ consists of 13 questions that assess subject satisfaction and appearance-related impacts associated with facial lines. Item 5 on the FLSQ asks How satisfied are you with the effect your treatment had on your facial lines? Responses included: very satisfied, mostly satisfied, neither satisfied or dissatisfied, mostly dissatisfied, or very dissatisfied. The percentage of subjects reporting a score of mostly satisfied or very satisfied with treatment are reported."|Day 60|Intent-to-Treat: all randomized subjects with data reported at this time point||Percentage of Subjects||95% Confidence Interval|Number
642712|NCT02261493|Secondary|Percentage of Subjects With ≥1-Grade Improvement From Baseline on the Investigator's FWS Rating of Forehead Line Severity at Rest|The Investigator assessed the severity of the subject's forehead lines at rest using the 4-grade FWS, where 0=none, 1=mild, 2=moderate, and 3=severe. The percentage of subjects with at least a 1-grade improvement assessed by the Investigator are reported.|Baseline, Day 30|Intent-to-Treat: all randomized subjects with at least a 1-grade improvement assessed by the Investigator on the FWS at rest||Percentage of Subjects||95% Confidence Interval|Number
642713|NCT02261493|Secondary|Percentage of Subjects With an Investigator Rating of None or Mild on the 4-Grade FWS for Forehead Line Severity at Maximum Eyebrow Elevation|"The Investigator assessed the severity of the subject's forehead lines at maximum eyebrow elevation using the 4-grade FWS, where 0=none, 1=mild, 2=moderate, and 3=severe. The percentage of subjects with a score of none and mild are reported."|Day 30|"Intent-to-Treat: all randomized subjects with a score of none and mild on the FWS at maximum eyebrow elevation"||Percentage of Subjects||95% Confidence Interval|Number
642714|NCT02261493|Primary|Percentage of Subjects With ≥2-Grade Improvement From Baseline on Both the Investigator's and Subject's Facial Wrinkle Scale (FWS) Ratings of Forehead Line Severity at Maximum Eyebrow Elevation|The Investigator and subject each assessed the severity of the subject's forehead lines at maximum eyebrow elevation using the 4-grade FWS, where 0=none, 1=mild, 2=moderate, and 3=severe. The percentage of subjects with at least a 2-grade improvement from baseline assessed by both the Investigator and the subject are reported.|Baseline, Day 30|Intent-to-Treat: all randomized subjects||Percentage of Subjects||95% Confidence Interval|Number
642715|NCT02261467|Secondary|Time to Retreatment Eligibility|Time to retreatment eligibility is defined as the number of days from treatment cycle 1 injection to the return to an Investigator FWS rating of moderate or severe at maximum eyebrow elevation. The FWS is a 4-grade scale, where 0=none, 1=mild, 2=moderate, and 3=severe. Only subjects who achieved a ≥ 2-grade improvement on both the Investigator and subject FWS ratings at maximum eyebrow elevation on Day 30 are included in the analysis.|12 Months|Intent-to-Treat: all randomized subjects who achieved a ≥ 2-grade improvement on both the Investigator and subject FWS ratings at maximum eyebrow elevation||Days||Standard Deviation|Median
642716|NCT02261467|Secondary|Percentage of Subjects With a ≥3-Point Improvement From Baseline on Item 4 of the 11-Point Facial Line Outcomes (FLO-11) Questionnaire©|"The FLO-11 assess the subject's psychological and appearance-related impacts associated with facial lines. Item 4 is I look older than my actual age because of my facial lines with a range of possible scores from 0 = not at all to 10 = very much. Only subjects with baseline scores ≥ 3 are included in the analysis."|Baseline, Day 30|Intent-to-Treat: all randomized subjects with baseline scores ≥ 3 on Item 4 of the FLO-11||Percentage of Subjects||95% Confidence Interval|Number
642717|NCT02261467|Secondary|Percentage of Subjects With ≥20-Point Improvement From Baseline on the Impact Domain of the FLSQ Among Subjects With Baseline Score ≥ 20 Points|The FLSQ consists of 13 questions that assess subject satisfaction and appearance-related impacts associated with facial lines. The Impact Domain measures the subject’s appearance-related and emotional impacts of treatment and is composed of 5 questions with a possible range of scores from 0 (worst) to 100 (best), using a transformed scale. Only subjects with baseline scores ≥ 20 are included in the analysis.|Baseline, Day 30|Intent-to-Treat: all randomized subjects with baseline scores ≥ 20 on the Impact Domain of the FLSQ||Percentage of Subjects||95% Confidence Interval|Number
642718|NCT02261467|Secondary|Percentage of Subjects Reporting Mostly Satisfied or Very Satisfied on the 5-Point Facial Line Satisfaction Questionnaire (FLSQ) Item 5|"The FLSQ consists of 13 questions that assess subject satisfaction and appearance-related impacts associated with facial lines. Item 5 on the FLSQ asks How satisfied are you with the effect your treatment had on your facial lines? Responses included: very satisfied, mostly satisfied, neither satisfied or dissatisfied, mostly dissatisfied, or very dissatisfied. The percentage of subjects reporting a score of mostly satisfied or very satisfied with treatment are reported."|Day 60|Intent-to-Treat: all randomized subjects with data reported at this time point||Percentage of Subjects||95% Confidence Interval|Number
642719|NCT02261467|Secondary|Percentage of Subjects With ≥1-Grade Improvement From Baseline on the Investigator's FWS Rating of Forehead Line Severity at Rest|The Investigator assessed the severity of the subject's forehead lines at rest using the 4-grade FWS, where 0=none, 1=mild, 2=moderate, and 3=severe. The percentage of subjects with at least a 1-grade improvement assessed by the Investigator are reported.|Baseline, Day 30|Intent-to-Treat: all randomized subjects with at least a 1-grade improvement assessed by the Investigator on the FWS at rest||Percentage of Subjects||95% Confidence Interval|Number
642720|NCT02261467|Secondary|Percentage of Subjects With an Investigator Rating of None or Mild on the 4-Grade FWS for Forehead Line Severity at Maximum Eyebrow Elevation|"The Investigator assessed the severity of the subject's forehead lines at maximum eyebrow elevation using the 4-grade FWS, where 0=none, 1=mild, 2=moderate, and 3=severe. The percentage of subjects with a score of none and mild are reported."|Day 30|"Intent-to-Treat: all randomized subjects with a score of none and mild on the FWS at maximum eyebrow elevation"||Percentage of Subjects||95% Confidence Interval|Number
642721|NCT02261467|Primary|Percentage of Subjects With ≥2-Grade Improvement From Baseline on Both the Investigator's and Subject's Facial Wrinkle Scale (FWS) Ratings of Forehead Line Severity at Maximum Eyebrow Elevation|The Investigator and subject each assessed the severity of the subject's forehead lines at maximum eyebrow elevation using the 4-grade FWS, where 0=none, 1=mild, 2=moderate, and 3=severe. The percentage of subjects with at least a 2-grade improvement from baseline assessed by both the Investigator and the subject are reported.|Baseline, Day 30|Intent-to-Treat: all randomized subjects||Percentage of Subjects||95% Confidence Interval|Number
642722|NCT02261428|Secondary|Presence of Blood on Catheter Immediately After Each Intervention|Immediately after each intervention recorded the presence or absence of blood on the catheter (Yes or No).|Within 2 seconds after catheter withdrawal.|||Catheters with presence of blood|||Number
642723|NCT02261428|Secondary|Diastolic Blood Pressure Immediately After Each Intervention|Immediately after each intervention recorded the diastolic blood pressure (mmHg).|Within 2 seconds after catheter withdrawal.|||mmHg||Standard Deviation|Mean
642724|NCT02261428|Secondary|Systolic Blood Pressure Immediately After Each Intervention|Immediately after each intervention recorded the systolic blood pressure (mmHg).|Within 2 seconds after catheter withdrawal.|||mmHg||Standard Deviation|Mean
642725|NCT02261428|Secondary|Heart Rate Immediately After Intervention|Immediately after each intervention recorded the heart rate (beats per minute).|Within 2 seconds after catheter withdrawal.|||Βeats per minute||Standard Deviation|Mean
642729|NCT02260882|Secondary|Percentage of Participants With an Adverse Event of Fatigue|An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of fatigue recorded on the VRC during the first 14 days after vaccination was recorded.|Up to 14 days after vaccination|All Subjects as Treated set: all participants who received study vaccine.||Percentage of participants|||Number
642730|NCT02260882|Secondary|Percentage of Participants With an Adverse Event of Headache|An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of headache recorded on the VRC during the first 14 days after vaccination was recorded.|Up to 14 days after vaccination|All Subjects as Treated set: all participants who received study vaccine.||Percentage of participants|||Number
642731|NCT02260882|Secondary|Percentage of Participants With an Adverse Event of Arthralgia|An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of arthralgia recorded on the VRC during the first 14 days after vaccination was recorded.|Up to 14 days after vaccination|All Subjects as Treated set: all participants who received study vaccine.||Percentage of participants|||Number
642732|NCT02260882|Secondary|Percentage of Participants With an Adverse Event of Myalgia|An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of myalgia recorded on the VRC during the first 14 days after vaccination was recorded.|Up to 14 days after vaccination|All Subjects as Treated set: all participants who received study vaccine.||Percentage of participants|||Number
642733|NCT02260882|Secondary|Percentage of Participants With an Adverse Event of Pyrexia|Percentage of participants with an adverse event of pyrexia (>=37.5°C, oral) recorded on the VRC during the first 5 days after vaccination was recorded.|Up to 5 days after vaccination|All Subjects as Treated set: all participants who received study vaccine.||Percentage of participants|||Number
642734|NCT02260882|Secondary|Percentage of Participants With an Adverse Event of Injection-site Pain|An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of injection-site pain recorded on the VRC during the first 5 days after vaccination was recorded.|Up to 5 days after vaccination|All Subjects as Treated set: all participants who received study vaccine.||Percentage of participants|||Number
642735|NCT02260882|Secondary|Percentage of Participants With an Adverse Event of Injection-site Swelling|An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of injection-site swelling recorded on the VRC during the first 5 days after vaccination was recorded.|Up to 5 days after vaccination|All Subjects as Treated set: all participants who received study vaccine.||Percentage of participants|||Number
642736|NCT02260882|Secondary|Percentage of Participants With an Adverse Event of Injection-site Erythema|An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of injection-site erythema recorded on the Vaccine Report Card (VRC) during the first 5 days after vaccination was recorded.|Up to 5 days after vaccination|All Subjects as Treated set: all participants who received study vaccine.||Percentage of participants|||Number
642737|NCT02260882|Secondary|Change From Baseline in Serotype-Specific Antibody Geometric Mean Concentration at 4 Weeks After Primary Vaccination|Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays. Geometric mean antibody concentrations (GMCs) were calculated at Baseline and 4 weeks postvaccination. Geometric Mean Fold Rise was the GMC at 4 weeks after vaccination minus the GMC at Baseline.|Baseline and 4 weeks after primary vaccination|Per Protocol Set: all participants in the Primary Vaccination Group except those with a protocol deviation, including those with blood collection outside the protocol-specified window||Geometric Mean Fold Rise||95% Confidence Interval|Geometric Mean
642738|NCT02260882|Primary|Change From Baseline in Serotype-Specific Antibody Geometric Mean Concentration at 4 Weeks After Revaccination|Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays. Geometric mean antibody concentrations (GMCs) were calculated at Baseline and 4 weeks postvaccination. Geometric Mean Fold Rise was the GMC at 4 weeks after vaccination minus the GMC at Baseline.|Baseline and 4 weeks after revaccination|Per Protocol Set: all participants in the Revaccination Group except those with a protocol deviation, including those with blood collection outside the protocol-specified window.||Geometric Mean Fold Rise||95% Confidence Interval|Geometric Mean
648271|NCT02107014|Primary|Change in IL-17F From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].|||pg/mL||95% Confidence Interval|Median
642787|NCT02259348|Primary|Percentage of Participants Engrafted by Day 42 Post-transplant|To estimate engraftment by day +42 post-transplant in patients who receive CD45RA-depleted haploidentical donor progenitor cell transplantation following reduced intensity conditioning regimen that includes haploidentical NK cells. Engraftment is defined as the first of 3 consecutive tests performed on different days of an ANC ≥ 500/mm^3 with evidence of donor cell engraftment.|Day 42 post transplantation|||percentage of participants|||Number
642755|NCT02260492|Secondary|Number of Participants With Adverse Events||From Screen (Day -28) until 1 week post last treatment|One subject who was assigned OT329 SOLIS received placebo treatment kit in error. The mistake was discovered on Day 1 and the patient was removed from the study. The patient was included in the OT329 SOLIS group for the intent-to-treat analysis but was put in the Placebo group for the Safety analysis as defined by the Statisical Analysis Plan.||Participants|||Count of Participants
642756|NCT02260492|Primary|FEV1 Trough|Bioequivalence comparison of trough lung function (FEV1) after 4 weeks of treatment with OT329 SOLIS or ADVAIR DISKUS.|Post-4 weeks of treatment|Intent-to-Treat||Liters||Standard Deviation|Mean
642757|NCT02260492|Primary|Area Under the Serial FEV1-time Curve (AUC 0-12h)|Bioequivalence comparison of lung function (FEV1) for 12 hours after the first dose on Day 1 following OT329 Solis and Advair Diskus treatment. Serial lung function measurements were made pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose.|0-12 hours after dosing on Day 1|Intent-to-treat (ITT)||Liters||Standard Deviation|Mean
642758|NCT02260440|Secondary|Overall Survival (OS)|Overall Survival (OS) (median) was determined using the number of months measured from the initial date of treatment to the recorded date of death of participants.|Up to 2 years|Participants who received at least one dose of study therapy (median, 3 cycles; range, 1-8).||months||95% Confidence Interval|Median
642759|NCT02260440|Secondary|Progression-free Survival (PFS)|Progression-free Survival (PFS) (median) was determined using the number of months measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression) of participants. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Up to 2 years|Participants who received at least one dose of study therapy (median, 3 cycles; range, 1-8).||months||95% Confidence Interval|Median
648272|NCT02107014|Primary|Change in IL-17A From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].|||pg/mL||95% Confidence Interval|Median
642760|NCT02260440|Primary|Objective Response Rate (ORR)|The objective response rate is estimated by the proportion (percentage) of participants with the best response of complete response (CR), or partial response (PR) by RECIST 1.1 criteria, with corresponding exact 95% confidence limits being reported. Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 14 months|Participants who received at least one dose of study therapy (median, 3 cycles; range, 1-8).||percentage of participants||95% Confidence Interval|Number
642761|NCT02260401|Secondary|Healthcare Utilization|We will determine if providing individualized reports to the LESS trial participants at 198 months impacts healthcare utilization for spinal stenosis between 18 and 24 months (including doctors visits, physical therapy, surgery, opioid use)|24 months||04/2017||||
642762|NCT02260401|Primary|Utilization of ESI|We will measure whether or not providing these individualized reports to patients impacts patients decision-making regarding use of epidural steroid injections between 18 and 24 months|24 months|||number of ESI between 18-24 months||Standard Deviation|Mean
642763|NCT02259608|Secondary|Cytokine Production Measured by ELISA Compared to Baseline|Ex-vivo cytokine production by PBMCs upon stimulation with several pathogens|0 weeks and 2 weeks|||ratio||Full Range|Mean
642764|NCT02259608|Primary|Cytokine Production Measured by ELISA Compared to Baseline|"Comparing tnfa production of PBMCs after 24h stimulation with candida before and 3 months after yBCG vaccination.
Baseline is set as 1."|0 weeks and 3 months|Ex-vivo cytokine production by PBMCs upon stimulation with several pathogens||ratio||Full Range|Mean
642765|NCT02259400|Secondary|Death||1 month|||participants|||Number
642766|NCT02259400|Secondary|Late Onset Sepsis||after fifth days of life up 2 month of life|||participants|||Number
642767|NCT02259400|Secondary|Early Onset Sepsis||5days from birth|||participants|||Number
642768|NCT02259400|Secondary|Newborns Who Received Multiple Surfactant Doses||10 days|||participants|||Number
642769|NCT02259400|Secondary|Necrotizing Enterocolitis (NEC)||1 month|||participants|||Number
642770|NCT02259400|Secondary|Patent Ductus Arteriosus Requiring Pharmacological Treatment (PDA)||first week of life|||participants|||Number
642771|NCT02259400|Secondary|Retinopathy of Prematurity (ROP)||3 month of life|||participants|||Number
642772|NCT02259400|Secondary|Periventricular Leukomalacia (PVL)||3 month of life|||participants|||Number
642773|NCT02259400|Secondary|Intraventricular Hemorrhage (IVH)||1 month of life|||participants|||Number
642774|NCT02259400|Secondary|Pneumothorax (PNX)||10 days|||participants|||Number
642775|NCT02259400|Secondary|Bronchopulmonary Dysplasia (BPD)||36 weeks of postconceptional age or time of discharge|2 newborns died in bipap group||participants|||Number
642776|NCT02259400|Secondary|Death||2 month|||participants|||Number
642777|NCT02259400|Primary|Failure of NIV Support|NUMBER OF NEWBORNS WHO FAILED WITH NON INVASIVE VENTILATION SUPPORT AND NEEDED INTUBATION AND INVASIVE MECHANICAL VENTILATION.|10 days|||participants|||Number
642778|NCT02259400|Primary|Duration of NIV Support|DURATION OF NON INVASIVE VENTILATION SUPPORT FOR RDS TREATMENT|10 days|||HOURS||Inter-Quartile Range|Median
642779|NCT02259348|Post-Hoc|Median Days to Absolute Neutrophil Count (ANC) Engraftment|ANC engraftment is defined as the first of 3 consecutive tests performed on different days of an ANC ≥ 500/mm^3 with evidence of donor cell engraftment.|Day 42 post transplantation|||days||Full Range|Median
642780|NCT02259348|Post-Hoc|Mean of Days to Absolute Neutrophil Count (ANC) Engraftment|ANC engraftment is defined as the first of 3 consecutive tests performed on different days of an ANC ≥ 500/mm^3 with evidence of donor cell engraftment.|Day 42 post transplantation|||days||Standard Deviation|Mean
642781|NCT02259348|Secondary|Rate of Transplant-related Mortality (TRM)|The cumulative incidence of transplant related mortality will be estimated using Kalbfleisch-Prentice method. Deaths before day 100 because of other reasons are the competing risk events.|100 days post transplantation|All six participants who received the protocol-defined treatment were evaluable for this analysis. One participant died of a non-transplant related cause (leukemia) prior to day 100. Although this participant did not complete the study to Day 100 post-transplantation, they were still evaluable for TRM.||participants|||Number
642782|NCT02259348|Secondary|Incidence and Severity of Chronic GvHD|"The cumulative incidence of chronic GvHD will be estimated using Kalbfleisch-Prentice method. Death is the competing risk event. The severity of chronic GvHD will be described. Chronic GvHD was evaluated using NIH Consensus Global Severity Scoring. The number of participants with incidence by severity is given."|one year post transplantation|||participants|||Number
642783|NCT02259348|Secondary|Incidence and Severity of Acute GvHD|The cumulative incidence of acute GvHD will be estimated using Kalbfleisch-Prentice method. Death is the competing risk event. The severity of acute GvHD. The number of participants with incidence by grade is given. Participants are graded on a scale from 1 to 4, with 1 being mild and 4 being severe.|100 days post transplantation|Two of six participants did not experience any acute GvHD.||participants|||Number
642784|NCT02259348|Secondary|Overall Survival (OS)|The Kaplan-Meier estimate of OS along with their standard errors will be calculated using the SAS macro (bmacro251-Excel2007\kme) available in the Department of Biostatistics at St. Jude, where OS = min (date of last follow-up, date of death) – date of transplant and all participants surviving at the time of analysis without events will be censored. The number of participants surviving to one-year post-transplantation is given.|one year post transplantation|||participants|||Number
642785|NCT02259348|Secondary|Event-free Survival (EFS)|The Kaplan-Meier estimate of event-free survival (EFS) along with their standard errors will be calculated using the SAS macro (bmacro251-Excel2007\kme) available in the Department of Biostatistics at St. Jude, where EFS = min (date of last follow-up, date of relapse, date of graft failure, date of death due to any cause) – date of transplant, and all participants surviving at the time of analysis without events will be censored. The number of participants who did not experience any of these events through one year post-transplant is given.|one year post transplantation|||participants|||Number
642786|NCT02259348|Secondary|Incidence of Malignant Relapse|The estimate of cumulative incidence of relapse will be estimated using Kalbfleisch-Prentice method. Death is the competing risk event. The number of participants with incidence of malignant relapse is given. Relapse was evaluated using standard WHO criteria for each disease.|one year post transplantation|||participants|||Number
642791|NCT02258529|Secondary|Duration of Response|Duration of response (DOR) was defined as the interval from the first documentation of complete response or partial response to the earlier of the first documentation of disease progression or death from any cause.||Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.|||||
642792|NCT02258529|Secondary|Time to Response|Time to response was defined as the the interval from the start of idelalisib treatment to the first documentation of complete or partial response.||Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.|||||
642793|NCT02258529|Secondary|Idelalisib Trough and Peak Plasma Concentrations||Predose and 1.5 hour postdose at Weeks 2, 4, and 12|Pharmacokinetic (PK) Analysis Set: all participants in the ITT Analysis Set who had the necessary baseline and on-study measurements to provide interpretable results for the specific parameters of interest.||ng/mL||Standard Deviation|Mean
642794|NCT02258529|Secondary|Rate of Grade ≥ 3 Transaminase Elevations Based on Laboratory Findings|The rate of Grade ≥ 3 transaminase elevations was defined as the number of participants with any Grade 3 or 4 alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevations.|Up to 24 weeks plus 30 days|ITT Analysis Set: all participants who received at least 1 dose of study drug.||percentage of participants|||Number
642795|NCT02258529|Secondary|Overall Safety Profile of Idelalisib as Measured by the Incidence of Adverse Events (AEs), Severe AEs (SAEs), AEs Leading to Idelalisib (IDL) Interruption, Idelalisib Dose Reduction, Premature Discontinuation of Idelalisib, or Death||Up to 24 weeks plus 30 days|Intent-to-Treat (ITT) Analysis Set: all participants who received at least 1 dose of study drug.||percentage of participants|||Number
642796|NCT02258529|Primary|Overall Response Rate|Overall response rate (ORR) was defined as the proportion of participants who achieve a confirmed complete or partial response during idelalisib treatment. ORR was to be assessed by an independent review committee (IRC).||Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.|||||
642797|NCT02258477|Secondary|Number of Days That a Problem Snack Food Was Consumed at Any Time of Day in a Week.|Study participant will record daily the time problem snack food was consumed. Note that the values in the data table below reflect the percentage of days within a week that subjects within each treatment dose consumed a problem snack food at any time of day. The data does not represent change from baseline, but rather percentage of days within a week (calculated by how many days within a week subject consumed the problem snack food at any time of day/ 7 days in a week) and can be compared week by week to see if there is any significant difference weekly when consuming a different dose of glucose.|4 weeks|33 subjects completed the 4 week study.||percentage of days in a week||Standard Deviation|Mean
642798|NCT02258477|Secondary|Number of Days That a Problem Snack Food Was Consumed at the Identified Time of Waning Dietary Self-control.|"Study participant will record if the problem snack was consumed each day within the 3 hour period following consumption of the study beverage.
Note that the values in the data table below reflect the percentage of days within a week that subjects within each treatment dose consumed a problem snack food at the identified time of waning dietary self-control. The data does not represent change from baseline, but rather percentage of days within a week (calculated by how many days within a week subject consumed the problem snack food at the identified time of waning dietary self-control/ 7 days in a week) and can be compared week by week to see if there is any significant difference weekly when consuming a different dose of glucose."|4 weeks|33 subjects completed the 4 week study.||percentage of days in a week||Standard Deviation|Mean
642799|NCT02258477|Primary|Responses to the Control of Eating Questionnaire|"Study participant will complete Eating Questionnaire at baseline and the next 4 visits. Each questionnaire item used a likert scale (with ratings from 1 - 10). All question pertain to the last 7 days. Questionnaire items #9 asked what one food makes it most difficult for you to control eating? and question #10 asked  What time are you particularly vulnerable to this one food. Higher ratings are consistent with a more significant or more frequent outcome.
Note that values in the data table below are absolute scores at each week that the subject consumed the noted treatment dose. As subjects were randomized to different sequence orders to receive the study beverages, subjects consumed any given treatment dose at different weeks (depending on their randomized sequence order)."|4 weeks|33 participants completed the 4 week study and were randomized to one of four treatment sequences. Thus, each subject received each treatment for one week.||units on a scale||Standard Deviation|Mean
642800|NCT02258412|Primary|Bacterial Colony Forming Units Present on Hand Prints After Time Spent in Common Areas|Hand print plates will be collected from HCWs immediately after use of hand hygiene product and after time spent in common areas. Each HCW will use both products at least 3 days apart. Hand print plates from each product for each HCW will be compared.|On each of 2 days, Hand print plates collected from one hand immediately after product use (T0) and from other hand after time spent in MICU common areas|||log(10) transformed CFU||95% Confidence Interval|Mean
642801|NCT02258334|Secondary|Geometric Mean Titer Ratios (GMTRs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Following Vaccination With the Respective Vaccine|Geometric mean titer ratios of antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the hemagglutination inhibition (HAI) assay.|Day 21 post-vaccination|Geometric mean titer ratios were assessed in the Per-Protocol Analysis Set.||Titer ratios||95% Confidence Interval|Geometric Mean
642802|NCT02258334|Secondary|Percentage of Participants With Seroconversion Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine|Antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the hemagglutination inhibition (HAI) assay. Seroconversion was defined as either a pre-vaccination titer < 10 (1/dil) and a post-vaccination titer ≥ 40 (1/dil) or a pre-vaccination titer ≥ 10 (1/dil) and a ≥ 4-fold increase in post-vaccination titer 21 days after vaccination.|Day 21 post-vaccination|Seroconversion was assessed in the Per-Protocol Analysis Set.||Percentage of participants|||Number
642843|NCT02256891|Primary|Return to Function|The Western Ontario Rotator Cuff Index total score is on a scale of 0-2100; where 0 is the best score and 2100 is the score. There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a baseline measure than those that completed the entire study.|6 months|||units on a scale||Standard Deviation|Mean
642803|NCT02258334|Secondary|Percentage of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine.|Antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the hemagglutination inhibition (HAI) assay. Seroprotection was defined as a titer ≥40 (l/dilution [dil]) at pre-vaccination and 21 days after vaccination.|Day 0 (pre-vaccination) and Day 21 post-vaccination|Seroprotection was assessed in the Per-Protocol Analysis Set.||Percentage of participants|||Number
642804|NCT02258334|Secondary|Geometric Mean Titers (GMTs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Before and Following Vaccination With the Respective Vaccine.|Geometric mean titers of antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the hemagglutination inhibition (HAI) assay.|Day 0 (pre-vaccination) and Day 21 post-vaccination|Geometric mean titers were assessed in the Per-Protocol Analysis Set.||Titers (1/dilution)||95% Confidence Interval|Geometric Mean
642805|NCT02258334|Primary|Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine|Injection-site reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3 Injection-site reactions: Pain, Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis, >100 mm. Grade 3 Systemic reactions: Fever, ≥39.0°C or ≥102.1°F; Headache, Malaise, Myalgia, and Shivering, Significant, prevents daily activity.|Day 0 up to Day 7 post-vaccination|Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set.||Percentage of participants|||Number
642806|NCT02257918|Secondary|Median in Vitro MIC Against AZD0914/ETX0914 and Ceftriaxone of Gonococcal Isolates From Culture of Isolates From the Pharyngeal Site at Day 6|For all positive cultures of specimens collected from the pharynx, isolates were collected and tested for antimicrobial susceptibility profiles and the MIC was determined. MIC was defined as the lowest concentration of an antimicrobial that inhibited the visible growth of a microorganism after overnight incubation. The MIC breakpoint was a chosen concentration of an antibiotic which defines whether a bacterial isolate is susceptible or resistant to the antibiotic. If the MIC was less than or equal to the susceptibility breakpoint, the bacteria was considered susceptible to the antibiotic. If the MIC was greater than this value, the bacteria was considered intermediate or resistant to the antibiotic.|Day 6|The analysis population includes all participants who had isolates collected and results reported at the timepoint.||µg/mL||Full Range|Median
642807|NCT02257918|Secondary|Median in Vitro MIC Against AZD0914/ETX0914 and Ceftriaxone of Gonococcal Isolates From Culture of Isolates From the Pharyngeal Site at Baseline|For all positive cultures of specimens collected from the pharynx, isolates were collected and tested for antimicrobial susceptibility profiles and the MIC was determined. MIC was defined as the lowest concentration of an antimicrobial that inhibited the visible growth of a microorganism after overnight incubation. The MIC breakpoint was a chosen concentration of an antibiotic which defines whether a bacterial isolate is susceptible or resistant to the antibiotic. If the MIC was less than or equal to the susceptibility breakpoint, the bacteria was considered susceptible to the antibiotic. If the MIC was greater than this value, the bacteria was considered intermediate or resistant to the antibiotic.|Day 1 (Baseline)|The analysis population includes all participants who had isolates collected and results reported at the timepoint.||µg/mL||Full Range|Median
642808|NCT02257918|Secondary|Median in Vitro MIC Against AZD0914/ETX0914 and Ceftriaxone of Gonococcal Isolates From Culture of Isolates From the Rectal Site at Day 6|For all positive cultures of specimens collected from the rectum, isolates were collected and tested for antimicrobial susceptibility profiles and the MIC was determined. MIC was defined as the lowest concentration of an antimicrobial that inhibited the visible growth of a microorganism after overnight incubation. The MIC breakpoint was a chosen concentration of an antibiotic which defines whether a bacterial isolate is susceptible or resistant to the antibiotic. If the MIC was less than or equal to the susceptibility breakpoint, the bacteria was considered susceptible to the antibiotic. If the MIC was greater than this value, the bacteria was considered intermediate or resistant to the antibiotic.|Day 6|The analysis population includes all participants who had isolates collected and results reported at the timepoint, of which there were none for this anatomical site and timepoint.|||||
642809|NCT02257918|Secondary|Median in Vitro MIC Against AZD0914/ETX0914 and Ceftriaxone of Gonococcal Isolates From Culture of Isolates From the Rectal Site at Baseline|For all positive cultures of specimens collected from the rectum, isolates were collected and tested for antimicrobial susceptibility profiles and the MIC was determined. MIC was defined as the lowest concentration of an antimicrobial that inhibited the visible growth of a microorganism after overnight incubation. The MIC breakpoint was a chosen concentration of an antibiotic which defines whether a bacterial isolate is susceptible or resistant to the antibiotic. If the MIC was less than or equal to the susceptibility breakpoint, the bacteria was considered susceptible to the antibiotic. If the MIC was greater than this value, the bacteria was considered intermediate or resistant to the antibiotic.|Day 1 (Baseline)|The analysis population includes all participants who had isolates collected and results reported at the timepoint.||µg/mL||Full Range|Median
642810|NCT02257918|Secondary|Median in Vitro MIC Against AZD0914/ETX0914 and Ceftriaxone of Gonococcal Isolates From Culture of Isolates From the Urethral/Cervical Sites at Day 6|For all positive cultures of specimens collected from the urethra or cervix, isolates were collected and tested for antimicrobial susceptibility profiles and the MIC was determined. MIC was defined as the lowest concentration of an antimicrobial that inhibited the visible growth of a microorganism after overnight incubation. The MIC breakpoint was a chosen concentration of an antibiotic which defines whether a bacterial isolate is susceptible or resistant to the antibiotic. If the MIC was less than or equal to the susceptibility breakpoint, the bacteria was considered susceptible to the antibiotic. If the MIC was greater than this value, the bacteria was considered intermediate or resistant to the antibiotic.|Day 6|The analysis population includes all participants who had isolates collected and results reported at the timepoint.||µg/mL||Full Range|Median
642844|NCT02256891|Primary|Return to Function|The Western Ontario Rotator Cuff Index total score is on a scale of 0-2100; where 0 is the best score and 2100 is the score. There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a baseline measure than those that completed the entire study.|Baseline|||units on a scale||Standard Deviation|Mean
642811|NCT02257918|Secondary|Median in Vitro Minimum Inhibitory Concentrations (MIC) Against AZD0914/ETX0914 and Ceftriaxone of Gonococcal Isolates From Culture of Isolates From the Urethral/Cervical Sites at Baseline|For all positive cultures of specimens collected from the urethra or cervix, isolates were collected and tested for antimicrobial susceptibility profiles and the minimum inhibitory concentration (MIC) was determined. MIC was defined as the lowest concentration of an antimicrobial that inhibited the visible growth of a microorganism after overnight incubation. The MIC breakpoint was a chosen concentration of an antibiotic which defines whether a bacterial isolate is susceptible or resistant to the antibiotic. If the MIC was less than or equal to the susceptibility breakpoint, the bacteria was considered susceptible to the antibiotic. If the MIC was greater than this value, the bacteria was considered intermediate or resistant to the antibiotic.|Day 1 (Baseline)|The analysis population includes all participants who had isolates collected and results reported at the timepoint.||µg/mL||Full Range|Median
642812|NCT02257918|Secondary|Number of Participants With no Detectable N. Gonorrhoeae Nucleic Acid in Pharyngeal Specimens in Each Study Arm|Gonorrhea and Chlamydia nucleic acid amplification tests (GC/CT NAAT) were performed at baseline and Day 6 with specimens collected at the pharyngeal site. Detectable nucleic acid was derived from GC/CT NAAT testing. If N. gonorrhoeae nucleic acid was detected, the result of the test was classified as positive. If no nucleic acid was detected, the result of the test was classified as negative. If a clear result could not be determined for any reason, the result of the test was classified as indeterminate.|Baseline and Day 6|The analysis population was restricted to participants who had a positive pharyngeal culture result for N. gonorrhoeae at baseline.||Participants|||Count of Participants
642813|NCT02257918|Secondary|Number of Participants With no Detectable N. Gonorrhoeae Nucleic Acid in Rectal Specimens in Each Study Arm|Gonorrhea and Chlamydia nucleic acid amplification tests (GC/CT NAAT) were performed at baseline and Day 6 with specimens collected at the rectal site. Detectable nucleic acid was derived from GC/CT NAAT testing. If N. gonorrhoeae nucleic acid was detected, the result of the test was classified as positive. If no nucleic acid was detected, the result of the test was classified as negative. If a clear result could not be determined for any reason, the result of the test was classified as indeterminate.|Baseline and Day 6|The analysis population was restricted to participants who had a positive rectal culture result for N. gonorrhoeae at baseline.||Participants|||Count of Participants
642814|NCT02257918|Secondary|Number of Participants With no Detectable N. Gonorrhoeae Nucleic Acid in Urethral/Cervical Specimens in Each Study Arm at Day 6.|Gonorrhea and Chlamydia nucleic acid amplification tests (GC/CT NAAT) were performed at Day 6 with specimens collected at the cervical/urethral site. Detectable nucleic acid was derived from GC/CT NAAT testing. If N. gonorrhoeae nucleic acid was detected, the result of the test was classified as positive. If no nucleic acid was detected, the result of the test was classified as negative. If a clear result could not be determined for any reason, the result of the test was classified as indeterminate.|Day 6|The analysis population was restricted to participants who had a positive cervical/urethral culture result for N. gonorrhoeae at baseline.||Participants|||Count of Participants
642815|NCT02257918|Secondary|Number of Participants With no Detectable N. Gonorrhoeae Nucleic Acid in Urethral/Cervical Specimens in Each Study Arm at Baseline.|Gonorrhea and Chlamydia nucleic acid amplification tests (GC/CT NAAT) were performed at baseline with specimens collected at the cervical/urethral site. Detectable nucleic acid was derived from GC/CT NAAT testing. If N. gonorrhoeae nucleic acid was detected, the result of the test was classified as positive. If no nucleic acid was detected, the result of the test was classified as negative. If a clear result could not be determined for any reason, the result of the test was classified as indeterminate.|Day 1 (Baseline)|The analysis population was restricted to participants who had a positive cervical/urethral culture result for N. gonorrhoeae at baseline.||Participants|||Count of Participants
642816|NCT02257918|Secondary|Number of Participants With Clinical Cure in Each Study Arm|A clinical cure was defined as the resolution of all signs and symptoms of gonorrhea (e.g. cervical/vaginal/urethral discharge, dysuria, dyspareunia, vulvovaginal irritation, sore throat) that were present at enrollment with the exception of vaginal discharge due to yeast vaginitis or bacterial vaginosis. A clinical failure was defined by the presence of any sign or symptom of gonorrhea that was also present at enrollment with the exception of vaginal discharge due to yeast vaginitis or bacterial vaginosis. The investigator also submitted his/her determination of whether the participant met or did not meet the criteria for clinical cure (or whether it is unknown if the participant met the criteria). In the event the investigator’s assessment of clinical cure did not coincide with the definitions of clinical cure/failure, the investigator’s assessment was the final adjudicator.|Day 6|The analysis population was restricted to participants who had a positive culture result for N. gonorrhoeae at any anatomical site and reported signs or symptoms of gonorrhea at baseline.||Participants|||Count of Participants
642817|NCT02257918|Secondary|Number of Participants With Microbiological Cure at Pharyngeal Sites in Each Study Arm|Microbiological cure was assessed at the Test of Cure visit (TOC). Microbiological Cure was derived from the Neisseria gonorrhoeae culture result and assessed by anatomical site. All subjects were swabbed at the pharyngeal site. Remel RapID NH tests were performed on pure cultures obtained from swab specimens. A participant was defined as a microbiological cure if N. gonorrhoeae was not detectable by culture at TOC.|Day 6|The analysis population was restricted to participants who had a positive culture result for N. gonorrhoeae at the pharyngeal site at baseline.||Participants|||Count of Participants
642818|NCT02257918|Secondary|Number of Participants With Microbiological Cure at Rectal Sites in Each Study Arm|Microbiological cure was assessed at the TOC visit. Microbiological cure was derived from the Neisseria gonorrhoeae culture result and assessed by anatomical site. All participants were swabbed at the rectal site. Remel RapID NH tests were performed on pure cultures obtained from swab specimens. A subject was defined as a microbiological cure if N. gonorrhoeae was not detectable by culture at TOC.|Day 6|The analysis population was limited to participants who had a positive culture result at the rectal site for N. gonorrhoeae at baseline.||Participants|||Count of Participants
642841|NCT02256891|Other Pre-specified|Spraspinatus Strength Measurements|Strength of supraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100.|Baseline|There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a baseline measure than those that completed the entire study.||percentage of uninvolved||Standard Deviation|Mean
642819|NCT02257918|Primary|Number of Participants Reporting Adverse Events (AEs) and Serious Adverse Events (SAEs) Considered Product-related.|Adverse events are defined as any untoward medical occurrence regardless of its causal relationship to the study treatment. Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation thereof was a congenital anomaly/birth defect; or may have jeopardized the subject or required intervention to prevent one of the outcomes. Relationship to study product was determined by the investigator and defined as a reasonable possibility that the study product caused the adverse event. Reasonable possibility means that there is evidence to suggest a causal relationship between the study product and the adverse event.|Day 1 through Day 31|All participants who received the study treatment were included in the analysis population. One participant enrolled in the Ceftriaxone arm was pregnant at enrollment and therefore, not treated.||Participants|||Count of Participants
642820|NCT02257918|Primary|Number of Participants With Microbiological Cure at Urethral or Cervical Sites in Each Study Arm|Microbiological cure was assessed at the Test of Cure visit (TOC). Microbiological Cure was derived from the Neisseria gonorrhoeae culture result and assessed by anatomical site. Male participants were swabbed at the urethral site and female participants at the cervical site. Remel RapID NH tests were performed on pure cultures obtained from swab specimens. A participant was defined as a microbiological cure if N. gonorrhoeae was not detectable by culture at TOC.|Day 6|The analysis population was restricted to participants who had a positive culture result for N. gonorrhoeae at the urethral/cervical site at baseline.||Participants|||Count of Participants
642821|NCT02257684|Secondary|The Immunogenicity of IV Pegcristaspase by Testing Anti-pegcrisantaspase and Anti-PEG Binding and Neutralizing Antibodies||30 Days|Not Applicable, as the study was terminated before this endpoint was analyzed.|||||
642822|NCT02257684|Secondary|The SAA Levels Over Time Following Repeated Administration in Children and Young Adults ALL/LBL and Hypersensitivity to Pegaspargase||30 Days|Not Applicable, as the study was terminated before this endpoint was analyzed.|||||
642823|NCT02257684|Secondary|The Pharmakokinetic (PK) Profile of IV Pegcrisantaspase in Children and Young Adults With ALL/LBL and Hypersensitivity to Pegaspargase. Pharmakokinetic Profiles to be Assessed Are: Half Life, Elimination Rate, Tmax, Cmax, AUC.||14 Days|Not Applicable, as the study was terminated before this endpoint was analyzed.|||||
642824|NCT02257684|Primary|The Serum Asparaginase Activity 14 Days After the First Infusion of Study Drug and the Adverse Events in All Participants.||1 Year|Not Applicable, as the study was terminated before this endpoint was analyzed.|||||
642825|NCT02257684|Primary|The Response Rate in Children & Young Adults With ALL/LBL and Hypersensitivity to Pegaspargase Defined as the Proportion of Subjects Having a Serum Asparaginase Activity (SAA) Level of >= 0.1 IU/mL Following the First IV Dose in Course 1||15 days during Course 1|Only 1 of the first 4 patients dosed achieved the predefined serum asparaginase activity (SAA) level above the 0.1 IU/mL therapeutic threshold 14 days following the first IV pegcrisantaspase dose in Course 1 (Primary Objective of the study).||SAA Level IU/mL|||Number
642826|NCT02257385|Secondary|Change From Baseline in Weighted Mean (WM) FEV1 Over 0-6 Hour Post-dose at Day 84|BL FEV1 was the mean of the 2 assessments made 30 and 5 min PD on Day 1. WM FEV1 derived by calculating the area under the FEV1/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. The WM was calculated at Days 1 and 84 using the 0-6 hr post-dose FEV1 measurements collected on that day, which included PD FEV1 (taken 30 and 5 min prior to dosing on Day 1 and the 30 and 5 min reading prior to dosing on Day 84) and post-dose FEV1 measurements at 1, 3 and 6 hr post-dose.WM change from BL was the WM at at the visit minus the BL value. Analysis was performed using a RM model with covariates of trt, BL FEV1 (mean of values measured at 30 and 5 min PD on Day 1) center group, day, day by BL and day by trt interaction, where day was nominal. Only par with data available at the specified TP were analyzed but all par w/o missing covariate information and with >=1 post-BL measurement were included in the analysis.|Baseline and Day 84|ITT Population||Liters||Standard Error|Least Squares Mean
642827|NCT02257385|Primary|Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) on Treatment Day 85 (Visit 8)|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in 1 second. BL was the mean of the 2 assessments made 30 and 5 minutes (min) pre-dose (PD) on Day 1. Trough FEV1 measurements were taken electronically by spirometry on Days 2, 28, 56, 84 and 85. Trough FEV1 on Day 85 is defined as the mean of the FEV1 values obtained at 23 and 24 hours (hr) after dosing on Day 84 (at Week 12 + 1 day). Analysis was performed using mixed model repeated measures (RM) with covariates of trt, BL FEV1 (mean of values measured at 30 and 5 min PD on Day 1), center group, day, day by BL interaction and day by trt interaction, where day was nominal.|Baseline (BL) and Day 85|Per Protocol (PP) Pop: all ITT Pop par who were not full protocol deviators considered to impact efficacy. Only par with data available at the specified time points (TP) were analyzed but all par without (w/o) missing covariate information and with >= 1 post BL measurement were included in the analysis.||Liters||Standard Error|Least Squares Mean
642828|NCT02257372|Secondary|Change From Baseline in Weighted Mean 0-6 Hour FEV1 Obtained Post-dose on Day 84|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The weighted mean FEV1 was derived by calculating the area under the curve, and then dividing the value by the relevant time interval. The weighted mean was calculated by performing six-hour serial spirometry from the pre-dose FEV1 and post-dose FEV1 measurements at 15 minutes, 30 minutes, 1 hour, 3 hours and 6 hours. Baseline FEV1 is the mean of the two assessments made 30 and 5 min pre-dose on Treatment Day 1. Change from Baseline was calculated as weighted mean value on Day 84 minus the Baseline value. Analysis was performed using mixed model repeated measures with covariates of treatment, baseline FEV1 (mean of the values measured at 30 min and 5 min pre-dose on Day 1), type of ICS/LABA , smoking status, Day, Day by baseline interaction and Day by treatment interaction, where Day is nominal.|Baseline and Day 84|ITT population||Liter||Standard Error|Least Squares Mean
642842|NCT02256891|Primary|Return to Function|Western Ontario Rotator Cuff Index|24 months|The Western Ontario Rotator Cuff Index total score is on a scale of 0-2100; where 0 is the best score and 2100 is the score. There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a 24 month measure than those that completed the entire study.||units on a scale||Standard Deviation|Mean
648273|NCT02107014|Primary|Change in IL-15 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].|||pg/mL||95% Confidence Interval|Median
642829|NCT02257372|Primary|Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) on Day 85|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Day 85 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Day 84 (Week 12). Trough FEV1 was measured using spirometry. BL FEV1 is the mean of the two assessments made 30 and 5 minutes (min) pre-dose on Day 1.Change from BL was calculated as the trough FEV1 value on Day 85 minus the BL value. Analysis was performed using mixed model repeated measures with covariates of treatment, BL FEV1 (mean of the values measured at 30 min and 5 min pre-dose on Day 1), type of ICS/LABA, smoking status, Day, Day by BL interaction and Day by treatment interaction, where Day is nominal.|Baseline (BL) and Day 85|Intent-to-treat (ITT) population: all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Only participants with data available at specific timepoint were analyzed.||Liter||Standard Error|Least Squares Mean
642830|NCT02256982|Primary|Number of Participants Post Operative/Radiation Therapy Complications|Out of the 3 participants enrolled, the patient in cohort 1 proceeded to surgery and 1 of the 2 patients in cohort 2 proceeded to RT. The other patient in cohort 2 developed disease progression and was removed from protocol.|90 Days|||participants|||Number
642831|NCT02256969|Primary|Tear Break Up Time (TBUT)|TBUT measures the amount of time, in seconds, a dry spot appears in the tear film after each blink. Values less than 10 seconds are considered abnormal.|4 week Time Point|||Seconds||Standard Deviation|Mean
642832|NCT02256969|Primary|Corneal Fluorescein Staining (CFS)|Is used to assess the level of corneal epitheliopathy that is related to dry eye disease. The CFS scale ranges from 0 to 15 scale, with 0 representing the minimum level of corneal epitheliopathy and 15 representing the maximum level of epitheliopathy.|4 week Time Point|||units on a scale||Standard Deviation|Mean
642833|NCT02256969|Primary|Symptom Assessment in Dry Eye (SANDE)|A two-item survey used to assess the frequency and severity of dry eye disease. The SANDE score is calculated by taking the square root of the product of the frequency of symptoms score and the severity of symptoms score. The SANDE scale ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms.|4 week Time Point|||units on a scale||Standard Deviation|Mean
642834|NCT02256969|Primary|Ocular Surface Disease Index (OSDI)|A 12-question survey used to measure the symptoms of dry eye disease. Each of the 12 individual questions rate one symptom on a 0-4 scale, with 4 meaning that the symptom is present all of the time and 0 meaning the symptom is present none of the time. The overall ODSI score is calculated by adding all of the values from the 12 questions, multiplying that value by 25, and dividing the resulting value by the number of questions answered. This results in an overall scale that ranges from 0-100, with 100 being severe dry eye symptoms and 0 being no dry eye symptoms.|4 week Time Point|||units on a scale||Standard Deviation|Mean
642835|NCT02256891|Other Pre-specified|Infraspinatus Strength Measurements|Strength of infraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100.|24 months|There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a baseline measure than those that completed the entire study.||percentage of uninvolved||Standard Deviation|Mean
642836|NCT02256891|Other Pre-specified|Infraspinatus Strength Measurements|Strength of infraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100.|6 months|There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a baseline measure than those that completed the entire study.||percentage of uninvolved||Standard Deviation|Mean
642837|NCT02256891|Other Pre-specified|Infraspinatus Strength Measurements|Strength of infraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100.|Baseline|There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a baseline measure than those that completed the entire study.||percentage of uninvolved||Standard Deviation|Mean
642838|NCT02256891|Other Pre-specified|Supraspinatus Strength Measurements|Strength of supraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100.|24 months|There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a baseline measure than those that completed the entire study.||percentage of uninvolved||Standard Deviation|Mean
642839|NCT02256891|Other Pre-specified|Supraspinatus Strength Measurements|Strength of supraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100.|6 months|There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a baseline measure than those that completed the entire study.||percentage of uninvolved||Standard Deviation|Mean
642840|NCT02256891|Other Pre-specified|MRI|"MRI was used to determine size of the defect in the proximal to distal, humeral to bursal, superior to inferior direction in all four tendons. All post operative rotator cuffs were described using the MRI rating system of Sugaya. This classification distinguishes 5 outcomes of rotator cuff repair based on integrity of the tendon determine by post operative MRI. Type I demonstrates the repaired rotator cuff has sufficient thickness and homogeneously low intensity on each image; Type II sufficient thickness with a partial high intensity area; Type III insufficient thickness without discontinuity, Type IV the presence of a minor discontinuity in more than one slice of each image suggestive of small tear; Type V the presence of a major discontinuity on each image suggestive of a large tear.
Higher grades are worse radiographic outcomes."|6 months|||scores on a scale||Standard Deviation|Mean
642871|NCT02256345|Secondary|Change in Mitochondrial Oxidative Capacity for Each Dose|Percent change in oxidative capacity (oxyhemoglobin levels) before and after occlusion|Baseline, end of week 1, end of week 2|||Percent change in oxidative capacity||95% Confidence Interval|Mean
642845|NCT02256553|Secondary|Percentage of Participants Who Experienced at Least One Local Application Site Reaction That Required Symptomatic Treatment|Events of local application site reactions included pharyngeal edema, laryngeal edema, mouth edema, oropharyngeal swelling, palatal edema, tongue swelling/edema, throat tightness, lip swelling/edema, ear pruritus, dysphagia, oral discomfort, glossodynia, oral pruritus, hypoaesthesia oral, throat irritation, paraesthesia oral or stomatitis. Events that occurred during in-clinic dosing were to be monitored and recorded by clinic staff. A Side Effect Report Card was used in Periods I-III to collect information on adverse events identified by the WAO as local side effects of SLIT that occurred within the first 60 minutes after study drug intake. During Period I, participants were to complete the report card once a day after MK-7243 was administered. During Period II, participants were to complete the report card twice a day, once after each tablet was administered. During Period III, participants were to complete the report card once a day after both tablets were administered.|During Period I, Period II and Period III (Up to 6 weeks)|All Treated Participants population consisted of all participants who received ≥1 dose of study drug.||Percentage of Participants||95% Confidence Interval|Number
642846|NCT02256553|Secondary|Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (AE)|An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug, was also an AE.|During Period I, Period II and Period III (Up to 6 weeks)|All Treated Participants population consisted of all participants who received ≥1 dose of study drug.||Percentage of Participants||95% Confidence Interval|Number
642847|NCT02256553|Secondary|Percentage of Participants Who Experienced at Least One Event of Local Application Site Reaction|Events of local application site reactions included pharyngeal edema, laryngeal edema, mouth edema, oropharyngeal swelling, palatal edema, tongue swelling/edema, throat tightness, lip swelling/edema, ear pruritus, dysphagia, oral discomfort, glossodynia, oral pruritus, hypoaesthesia oral, throat irritation, paraesthesia oral or stomatitis. Events that occurred during in-clinic dosing were to be monitored and recorded by clinic staff. A Side Effect Report Card was used in Periods I-III to collect information on adverse events identified by the WAO as local side effects of SLIT that occurred within the first 60 minutes after study drug intake. During Period I, participants were to complete the report card once a day after MK-7243 was administered. During Period II, participants were to complete the report card twice a day, once after each tablet was administered. During Period III, participants were to complete the report card once a day after both tablets were administered.|During Period I, Period II and Period III (Up to 6 weeks)|All Treated Participants population consisted of all participants who received ≥1 dose of study drug.||Percentage of Participants||95% Confidence Interval|Number
642848|NCT02256553|Primary|Percentage of Participants Who Experienced at Least One Event of Local Swelling|Events of local swelling included pharyngeal edema, laryngeal edema, mouth edema, oropharyngeal swelling, palatal edema, tongue swelling/edema, or throat tightness. Events that occurred during in-clinic dosing were to be monitored and recorded by clinic staff. A Side Effect Report Card was used in Periods I-III to collect information on adverse events identified by the World Allergy Organization (WAO) as local side effects of sublingual immunotherapy (SLIT) that occurred within the first 60 minutes after study drug intake. During Period I, participants were to complete the report card once a day after MK-7243 was administered. During Period II, participants were to complete the report card twice a day, once after each tablet was administered. During Period III, participants were to complete the report card once a day after both tablets were administered.|During Period I, Period II and Period III (Up to 6 weeks)|All Treated Participants population consisted of all participants who received ≥1 dose of study drug.||Percentage of Participants||95% Confidence Interval|Number
642849|NCT02256488|Secondary|Number of Subjects With Unsolicited Adverse Events|Safety was assessed as the number of subjects who reported Unsolicited Adverse Events after vaccination of TIVc and control vaccine.|Day 1 through day 22|Unsolicited Safety Set-All subjects in the exposed set with unsolicited AE data postvaccination.||Subjects|||Number
642850|NCT02256488|Secondary|Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIVc and TIVf|Safety was assessed as the number of subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after vaccination of TIVc and control vaccines.|Day 1 through day 7 (without 30 min)|Solicited Safety Set-All subjects in the exposed set with any solicited AE data postvaccination or indicators of solicited AEs postvaccination||Subjects|||Number
642851|NCT02256488|Secondary|Percentages of Subjects Who Achieved HI Seroconversion and HI Titer ≥1:40 Against Each of Three Strains After One Vaccination of TIVc and TIVf Vaccine.|"Percentages of subjects achieving HI seroconversion after each of three vaccine strains were measured three weeks after vaccination of TIVc or TIVf vaccine (day 22).
Percentages of subjects who achieved HI titer ≥1:40 against each of three vaccine strains were measured three weeks after one vaccination of TIVc or TIVf vaccine.
HI assay analysis for TIVc vaccine was based on cell-based antigen and for TIVf vaccine was based on egg based antigen.
According to Center for Biologics Evaluation and Research recommendations (CBER 2007), CBER criteria are met when the lower limit of the 2-sided 95% CI for seroconversion/significant increase is ≥ 40%, and the lower limit of the 2-sided 95% CI for HI titers ≥ 1:40 is ≥ 70%."|Day 22|FAS(Full Analysis Set) All subjects in the Enrolled Population who: ▫ receive a study vaccination and provide immunogenicity data at Day 1 and at Day 22 FAS populations was analyzed “as randomized” (i.e., according to the vaccine a subject was designated to receive, which may be different from the vaccine the subject actually received).||percentages of subjects||95% Confidence Interval|Number
642852|NCT02256488|Primary|Immunologic Equivalence of 3 Consecutive Influenza Vaccine (TIVc) Production Lots.|Hemagglutination inhibition (HI) geometric mean titers (GMTs) achieved by subjects, for each three vaccine strains, three weeks after one vaccination of one lot of TIVc vaccine (Day 22), evaluated using HI antigen assay.|Day 22|Per Protocol Set(PPS) All subjects in the FAS (Full Analysis Set) Immunogenicity Population who were not excluded due to reasons defined prior to unblinding or analysis.||Titers||95% Confidence Interval|Geometric Mean
642872|NCT02256345|Secondary|Change in Vasodilatory Reserve for Each Dose|Percent change in peak vascular resistance from rest to peak exercise|Baseline, end of week 1, end of week 2|||%change in peak vascular resistance||95% Confidence Interval|Mean
642873|NCT02256345|Primary|Change in Peak Oxygen Uptake (VO2) From Baseline Upto 1 Week of Administration for Each Dose|Peak oxygen uptake (VO2) defined as the average value obtained during the last 30 seconds of exercise.|Baseline, end of week 1, end of week 2|||L/min||95% Confidence Interval|Mean
642869|NCT02256358|Primary|Emergence Agitation|The primary endpoint is the incidence of postoperative emergence agitation that was defined as an Aono's four-point scale(AFPS) score of 3 or higher.|During 30 minutes after extubation at post-anesthetic care unit, every 5 minutes|||participants|||Number
642870|NCT02256345|Secondary|Change in Aortic Augmentation Index|Percent change in augmentation index, whereas augmentation index at each time point (visit) is defined as the amplitude of the second peak to the first peak of the aortic pulse wave form multiplied by 100: augmentation index = (P2/P1)×100.|Baseline, end of week 1, end of week 2|||Percent change in augumentation index||95% Confidence Interval|Mean
642874|NCT02256072|Secondary|Satisfaction With Intervention Tool Score at Immediate Post-test, 1 and 3-months|Overall satisfaction with the intervention or attention control as measured by the “Satisfaction with Intervention Tool.” Tests will be performed at a two-sided 5% significance level.|baseline, post-intervention, 1 month, and 3 months|Due to errors in the data collection method, it is not possible to summarize the data for reporting.|||||
642875|NCT02256072|Secondary|Knowledge of Home Services Score at Immediate Post-test, 1 and 3-months|Knowledge of home services score at all follow-up time points as measured by “Understanding of Home Services” assessment. This is a 6-item knowledge assessment; each question is scored as correct or incorrect and questions are equally weighted. The total possible range of scores is 0-6,with 0 being low knowledge and 6 being high.|baseline, post-intervention, 1 month, and 3 months|Participants with a complete baseline planning behavior score and either a complete one-month or three-month planning behavior score.||units on a scale||Standard Deviation|Mean
642876|NCT02256072|Secondary|Confidence in Accessing Home Services Score at Immediate Post-test, 1 and 3-months|Participant confidence in accessing home services based on a 5-item questionnaire. The score is the equally-weighted sum of responses to the five questions in the CAHS instrument. Each question has a scale of 1-5, giving a total possible range of 5-25, with 5 representing low confidence and 25 representing high confidence. No subscores are calculated.|baseline, post-intervention, 1 month, and 3 months|Participants with a complete baseline planning behavior score and either a complete one-month or three-month planning behavior score.||units on a scale||Standard Deviation|Mean
642877|NCT02256072|Secondary|Planning Perception Score at Baseline, Immediate Post-test, 1 and 3-months|Planning perception score (ranging from 5-25 points where higher values are considered to be a better outcome) at all follow-up time points as measured by the “Planning Perception” assessment. This secondary outcome measure will be assessed at baseline, immediate post-test, 1, and 3-months.|baseline, post-intervention, 1 month, and 3 months|Participants with a complete baseline planning behavior score and either a complete one-month or three-month planning behavior score.||units on a scale||Standard Deviation|Mean
642878|NCT02256072|Primary|Planning Behavior Score at 1-month|The primary endpoint for this study is planning behavior score (ranging from 5-25 points; where higher values are considered to be a better outcome) at one month post-intervention/attention control as measured by the “Planning Implementation (Behavior)” assessment. The outcome measure will be assessed at baseline and one month from baseline. Primary endpoint analyses will consist of an analysis of covariance (ANCOVA) comparing mean planning behavior score at one month post-intervention/attention control while controlling for baseline planning behavior score. All analyses will assume a type I error rate of 5%.|baseline and 1 month|All randomized participants with a complete planning behavior score at baseline and one-month.||units on a scale||Standard Deviation|Mean
642879|NCT02255565|Secondary|Clinical Global Impression - Improvement (CGI-I)|The CGI-I scale summarizes the clinician's impression of the participant's symptom improvement and ranges from 1-7 with 1 representing very much improved and 7 representing very much worse.|once a week for 6 weeks|||units on a scale||Standard Deviation|Mean
642880|NCT02255565|Secondary|Clinical Global Impressions-ADHD - Severity|The CGI-S scale summarizes the clinician's impression of the participant's symptom severity and ranges from 1-7 with 1 representing normal (not at all ill) and 7 representing extremely ill.|once a week for 6 weeks|||units on a scale||Standard Deviation|Mean
642881|NCT02255565|Primary|ADHD Rating Scale - IV|Measures the severity of Total ADHD symptoms, Inattention and Hyperactivity/Impulsive symptoms. The Inattention and Hyperactivity/Impulsive symptoms can range from 0 to 27 each, with a higher score reflecting more severe ADHD symptoms. The total score is calculated by summing the inattention and Hyperactivity/Impulsive subscales. The total score can range from 0 to 54 with a higher score reflecting more severe ADHD symptoms.|once a week for 6 weeks|||units on a scale||Standard Deviation|Mean
642882|NCT02255279|Secondary|Percentages of Subjects With a HI Titer ≥ 40, ≥110 and ≥330 and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects.|Percentage of subjects with a HI titer ≥ 40, ≥110 and ≥330 on Day 1, Day 22 (non naïve subjects) or Day 50 (naïve subjects), in all three homologous virus strains, 21 days after last immunization, in subjects 6 to <72 months of age.|Day 1 and Day 22 (vaccine non-naive subjects) or Day 50 (vaccine naive subjects) post vaccination|Analysis performed on the Per Protocol Set.||Percentage of subjects||95% Confidence Interval|Number
642883|NCT02255279|Secondary|Geometric Mean Ratios (GMRs) of HI and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects.|GMRs of HI, day 22/day 1 (non-naive subjects) or day 50/day 1 (naive subjects) in all three homologous virus strains, 21 days after last immunization, in subjects 6 to <72 months of age. As the non-inferiority of aTIV to TIV has been established, GMT ratio of aTIV relative to TIV in all three homologous virus strains, 21 days after last immunization in subjects 6 to <72 months of age was evaluated using margins greater than the non-inferiority cut-off of 0.67.|Day 1 and Day 22 (vaccine non-naive subjects) or Day 50 (vaccine naive subjects) post vaccination|Analysis performed on the Per Protocol Set.||Ratios||95% Confidence Interval|Geometric Mean
642884|NCT02255279|Secondary|Percentages of Subjects Achieving Seroconversion in Hemagglutination Inhibition (HI) Titers and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects.|Percentages of subjects with seroconversion in all three homologous virus strains, 21 days after last immunization, in subjects 6 to <72 months of age, defined as: HI ≥ 40 subject with a pre-vaccination HI titer <10; a minimum 4-fold increase HI titer for subjects with a prevaccination HI titer ≥10, on Day 22 (non-naive subjects) or Day 50 (naive subjects), as applicable.|Day 1 and Day 22 (vaccine non-naive subjects) or Day 50 (vaccine naive subjects) post vaccination|Analysis performed on the Per Protocol Set.||Percentages of subjects||95% Confidence Interval|Number
642885|NCT02255279|Primary|Geometric Mean Titers (GMTs), in All Three Homologous Virus Strains in Subjects 6 to < 72 Months of Age.|"Antibody response was assessed in terms of GMTs in all three homologous virus strains, 21 days after last immunization, in subjects 6 to <72 months of age.
The study is considered a success if the 21 days after last immunization GMT ratios of aTIV relative to TIV demonstrate as non-inferior with the lower limit (LL) of the two sided 95% confidence interval (CI) above 0.67 (-0.176 on log10 scale) for each vaccine strain (Center for Biologics Evaluation and Research {CBER} Guideline on Seasonal Vaccines May 2007)."|Day 1 and Day 22 (vaccine non-naïve subjects) or Day 50 (vaccine naïve subjects) post vaccination|Analysis performed on the Per Protocol Set.||Titers||95% Confidence Interval|Geometric Mean
642886|NCT02255279|Primary|Number of Non-naive Subjects Aged 6 to < 72 Months Reporting All Unsolicited AEs From Day 1 to Day 22|Number of non-naive subjects aged 6 to < 72 months reporting all unsolicited AEs, medically attended AEs, AE leading to study withdrawal and SAEs from Day 1 to Day 22.|From Day 1 to Day 22|Analysis performed on the Unsolicited Safety Set.||Participants|||Number
642887|NCT02255279|Primary|Number of Naive Subjects Aged 6 to < 72 Months Reporting All Unsolicited AEs From Day 1 to Day 50.|Number of naive subjects aged 6 to < 72 months reporting all unsolicited AEs, medically attended AEs, AE leading to study withdrawal and serious AEs (SAEs) from Day 1 to Day 50.|From Day 1 to Day 50|Analysis performed on the Unsolicited Safety Set.||Participants|||Number
642888|NCT02255279|Primary|Number of Non-naive Subjects ≥36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination.|Number of non-naive subjects ≥36 months to < 72 months old reporting solicited local and systemic AEs from Day 1 to Day 7 after vaccination.|From Day 1 to Day 7|Analysis performed on the Solicited Safety Set.||Participants|||Number
642889|NCT02255279|Primary|Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination.|Number of naive subjects ≥ 36 months to < 72 months old reporting solicited local and systemic AEs from Day 1 to Day 7 after first vaccination and from Day 29 to Day 35 after second vaccination.|From Day 1 to Day 7 by vaccination|Analysis performed on the Solicited Safety Set.||Participants|||Number
642890|NCT02255279|Primary|Number of Non-naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 After Vaccination.|Number of non-naive subjects 6 to < 36 months old reporting solicited local and systemic AEs from Day 1 to Day 7 after vaccination.|From Day 1 to Day 7|Analysis performed on the Solicited Safety Set.||Participants|||Number
642891|NCT02255279|Primary|Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination.|Number of naive subjects 6 to < 36 months old reporting solicited local and systemic AEs from Day 1 to Day 7 after first vaccination and from Day 29 to Day 35 after second vaccination.|From Day 1 to Day 7 by vaccination|Analysis performed on the Solicited Safety Set.||Participants|||Number
642892|NCT02255149|Primary|Bone Height|Diameter of the bone measured from the alveolar crest to the inferior alveolar nerve after the grafting procedures from CBCT images.|5 months|||millimeters||Full Range|Mean
642928|NCT02253654|Secondary|Number of RBC Units Transfused Overall and During Each Study Period|The number of red blood cell (RBC) units transfused during the study and during each study period.|Overall Study: Study week 1 to week 41; Titration Period: Study week 1 to week 12; Evaluation Period: Study week 13 to week 37; Safety Follow-up Period: Study week 38 to week 41|Primary analysis set with available data in each study period||participants|||Number
642929|NCT02253654|Secondary|Weekly Epoetin Alfa Dose at Each Visit||Weeks 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, and 35|Primary analysis set with available data at each time point||units||Standard Deviation|Mean
642930|NCT02253654|Secondary|Percentage of Participants With Hemoglobin Excursions at Each Visit|An excursion is identified as an event when a hemoglobin concentration fell below or exceeded the pre-specified thresholds of: - < 9.0 g/dL, or - > 11.0 g/dL, or - > 12.0 g/dL. The percentage of participants with any excursions and excursions in each subcategory at each time point and overall during the study are reported.|Baseline (screening visit) and weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, and 37|Primary analysis set with available data at each time point||percentage of participants|||Number
642911|NCT02254772|Secondary|Median Time to Progression (TTP)|Tumor progression was assessed as any new lesion or increase by ≥ 50% of any previously-involved site after treatment nadir.|Up to 2 years|1 participant had stable disease, but did not provide a final follow-up at 2 years.||Months||Full Range|Median
642912|NCT02254772|Secondary|Tumor Response|"Tumor response was assessed per the Cheson Criteria for low-grade B-cell lymphomas.
Complete Response (CR) – No evidence disease. Partial Response (PR) – Regression of measurable disease with no new sites Progressive Disease (PD) – Any new lesion or increase by ≥ 50% of any previously-involved site after treatment nadir.
Stable Disease (SD) – Any status that is not CR; PR; or PD. See references (Cheson BD, et al. J Clin Oncol. Apr 1999;17(4):1244. PubMed ID 10561185."|Up to 2 years|Note that 1 participants initially experienced a partial response (PR), but later had progressive disease (PD).||participants|||Number
642913|NCT02254772|Primary|Dose-limiting Toxicity (DLT) of Ipilimumab Plus a Fixed Dose of SD-101 (1 mg/Week)|"To determine the safety and tolerability of SD-101 (1 mg/week) and local low dose radiation plus escalating doses of subcutaneously (SC)-administered ipilimumab, the incidence of dose-limiting toxicities (DLT) will be assessed according to the following DLT definitions. Related adverse events (AEs) are toxicities. “Treatment” includes radiation therapy.
Grade 4 treatment-related AE
Any drug-related AE ≥ Grade 3, including injection site reaction
≥ Grade 3 treatment-related clinical autoimmune reaction involving major organs (defined as liver, pancreas, lung, heart, kidney, bowel, bone marrow, eye, or central nervous system) which does not resolve to baseline or Grade 1 within 6 weeks
Treatment-related AE ≥ Grade 3 that persists despite adequate/maximal medical therapy and/or prophylaxis, EXCEPT
Treatment-related skin rash ≤ Grade 3, that does not require systemic steroid therapy or other immunosuppressive therapy OR
Grade 3 flu-like AEs
Uveitis ≥ Grade 2"|Up to 10 weeks|Only the starting dose level of 10 mg ipilimumab plus SD-101 (1 mg/week) was evaluated. The dose level of ipilimumab could not be escalated due to inability to obtain a higher concentration of ipilimumab.||Dose-limiting toxicity events|||Number
642931|NCT02253654|Secondary|Hemoglobin Intra-subject Variability|Intra-subject variability was defined for each participant as the standard deviation (SD) of all of the hemoglobin concentrations during the evaluation period for the participant. The mean intra-subject SD for all participants is the sum of the intra-subject SDs divided by the total number of participants evaluated.|The evaluation period (weeks 13 to 37)|Primary analysis set||g/dL||Standard Deviation|Mean
642914|NCT02254551|Secondary|Overall Response|Number of patients with confirmed Complete Response (CR), Very Good Partial Response (VGPR), Partial Response (PR), Progressive Disease (PD) or Stable Disease (SD) according to International Myeloma Working Group (IMWG) Uniform Response Criteria. CR=5% or less plasma cells in bone marrow, disappearance of soft tissue plasmacytoma, negative immunofixation on serum and urine. VGPR=Serum and urine M-protein detectable by immunofixation but not by electrophoresis, disappearance of any soft tissue plasmacytomas that were present at baseline. PR= at least 50% reduction from baseline in serum M-protein and at least 90% reduction from baseline in 24hr urinary M-protein. PD=Increase of 25% or more from nadir in serum or urine proteins. SD= not meeting criteria for CR, VGPR, PR or PD.|Every 3 weeks up to 48 weeks|Of 7 enrolled patients, 1 was deemed ineligible and was excluded from efficacy analyses. At a median follow-up of 6 weeks, 3 patients in Cohort 1 had progressive disease and 3 had stable disease. Study was terminated after reviewing data from this first lead-in cohort.||Participants|||Count of Participants
642915|NCT02254551|Primary|Time to Disease Progression|Time to progression (TTP) is measured from Day 1 of study drug administration to disease progression using International Myeloma Working Group (IMWG) Uniform Response Criteria.|every 3 weeks up to 48 weeks, then every 3 months thereafter up to 3 years from initiation of study treatment.|This outcome measure was to be assessed during the expansion phase of the study. The study closed early and did not proceed to this phase of the study. There is no data to report for this outcome measure.|||||
642916|NCT02254551|Primary|Maximum Tolerated Dose (MTD) of LDE225 Plus Bortezomib|During the safety lead-in, a standard 3+3 dose escalation design was used to establish the MTD for LDE225 in combination with bortezomib. The MTD would be determined by the highest dose at which ≤1 of 6 patients experiences a dose-limiting toxicity (DLT) during one cycle (21 days) of therapy. If 2 of 6 patients within a dose level experienced a DLT, that dose level would be defined as exceeding MTD and no further dose escalation would occur. The previous dose level would be considered the MTD.|every 3 weeks up to 48 weeks||||||Number
642917|NCT02254486|Secondary|Polyp Detection Rate (Overall Colon)|Comparison of the number of patients with at least one polyp detected in the overall colon when NER1006 is used for bowel cleansing versus number detected when trisulfate is used. Polyp detection rate defined as the number of patients with at least one polyp in the overall colon.|Two days (from day of first dosing to day of colonoscopy)|Modified Full Analysis Set||Participants|||Number
642918|NCT02254486|Secondary|Polyp Detection Rate (Colon Ascendens)|Comparison of the number of patients with at least one polyp detected in the colon ascendens when NER1006 is used for bowel cleansing versus number detected when trisulfate is used. Polyp detection rate defined as the number of patients with at least one polyp in the colon ascendens.|Two days (from day of first dosing to day of colonoscopy)|Modified Full Analysis Set||Participants|||Number
642919|NCT02254486|Secondary|Adenoma Detection Rate (Overall Colon)|Comparison of the number of patients with at least one adenoma detected in the overall colon when NER1006 is used for bowel cleansing versus number detected when trisulfate is used. Adenoma detection rate defined as number of patients with at least one adenoma in the overall colon.|Two days (from day of first dosing to day of colonoscopy)|Modified Full Analysis Set||Participants|||Number
642920|NCT02254486|Secondary|Adenoma Detection Rate (Colon Ascendens)|Comparison of the number of patients with at least one adenoma detected in the colon ascendens when NER1006 is used for bowel cleansing versus when trisulfate is used. Adenoma detection rate defined as the number of patients with at least one adenoma in the colon ascendens.|Two days (from day of first dosing to day of colonoscopy)|Modified Full Analysis Set||Participants|||Number
642921|NCT02254486|Primary|Number of Patients With Highly Effective Bowel Cleansing (Colon Ascendens)|Comparison of 'Excellent plus good' cleansing of the colon ascendens using NER1006 versus Trisulfate solution. Highly effective bowel cleansing corresponds to scores 3 (Good) or 4 (Excellent) of the HCS. Adequate plus failure bowel cleansing corresponds to score 0-2.|Two days (from day of first dosing to day of colonoscopy)|Modified Full Analysis Set||Participants|||Number
642922|NCT02254486|Primary|Number of Participants With Effective Bowel Cleansing (Overall Colon)|The overall quality of bowel cleansing was assessed by a blinded colonoscopist using the Harefield Cleansing Scale (HCS). Comparison of overall success of cleansing with NER1006 versus Trisulfate solution was evaluated using a non-inferiority study design. A final grading of A, B, C, or D was assigned automatically according to the HCS, where grades of A and B were classified as successful (i.e. all mucosa could be visualized) and C and D were classified as unsuccessful.|Two days (from day of first dosing to day of colonoscopy)|Modified Full Analysis Set||Participants|||Number
642923|NCT02254460|Primary|Fractional Iron Absorption|Iron uptake was measured using stable isotopes of 57Fe and 58Fe to label the test and control products. Fractional iron absorption levels of 57Fe and 58Fe were calculated, to give a direct measure of the iron uptake from each of the study treatments.|Day 15|Per protocol (PP) population, defined as all participants who received at least one study treatment administration and who did not have any protocol violations deemed to affect evaluation of the iron absorption. This analysis was conducted on PP population.||% Iron Absorbed||Standard Deviation|Mean
642924|NCT02254252|Secondary|Side-effects|Patients were asked and underwent physical examination regarding the common and uncommon side effects attributed to anti-angina medications|1 month||||||
642925|NCT02254252|Primary|Canadian Cardiovascular Society (CCS) Grading of Angina Pectoris|One month after treatment, patients were asked to describe the angina episode and based on their descriptions, the CCS class of chest pain was determined. Based on patient’s description of the anginal episodes, angina severity was classified into one of CCS class I (angina only with prolonged demanding physical activity), Class II (Slight limitation, with angina only during vigorous physical activity), Class III (Symptoms with everyday living activities), or class IV (angina at rest).|1 month|||participants|||Number
642926|NCT02254252|Primary|Angina Episode Intensity|One month after treatment, patients were asked to determine the average intensity of chest pain in experienced episodes using a Likert-type scale of 0 to 10, where 0 indicated lowest intensity/no pain and 10 indicated the highest possible pain experienced.|1 month|||units on a scale||Standard Deviation|Mean
642927|NCT02254252|Primary|Angina Episode Frequnecy|One month after treatment, patients were asked to determine the frequency of angina episodes in the preceding week.|1 month|||episodes per week||Standard Deviation|Mean
643732|NCT02229864|Secondary|Number of Subjects With Target Lesion Failure (Cardiac Death, TVMI, TLR)|Target Lesion Failure (TLF) includes Cardiac Death, Target vessel - myocardial infarction and Target Lesion Revascularization (TLR).|0 to 393 Days|||Participants|||Count of Participants
642932|NCT02253654|Secondary|Hemoglobin Rate of Change at Each Visit|Hemoglobin rate of change (ROC) was calculated for each visit using the following formula: ROC = (current visit hemoglobin value - previous visit hemoglobin value) / number of days between each visit * 14. A positive value indicates a rate of rise and a negative value indicates a rate of decline.|Baseline (screening visit) and weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, and 37|Primary analysis set with available data at each time point||g/dL/2 weeks||Standard Deviation|Mean
642933|NCT02253654|Secondary|Percentage of Participants With Transfusion Events Overall and During Each Study Period|The percentage of participants who received red blood cell (RBC) transfusions during the study and during each study period.|Overall Study: Study week 1 to week 41; Titration Period: Study week 1 to week 12; Evaluation Period: Study week 13 to week 37; Safety Follow-up Period: Study week 38 to week 41|Primary analysis set with available data in each study period||percentage of participants|||Number
642934|NCT02253654|Secondary|Hemoglobin Concentration at Each Visit||Baseline (screening visit) and weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, and 37|Primary analysis set with available data at each time point||g/dL||Standard Deviation|Mean
642935|NCT02253654|Primary|Percentage of Hemoglobin Measurements Within 10 to 11 g/dL During the Evaluation Period|Hemoglobin was measured every 2 weeks during the evaluation period. The percentage of these measurements that were within the range of 10-11 g/dL was calculated for each participant.|The evaluation period (weeks 13-37)|The Primary Analysis Set which consists of all randomized participants who had at least 6 hemoglobin measurements during the evaluation period while on study and receiving investigational product.||percentage of hemoglobin measurements||Standard Deviation|Mean
642936|NCT02253173|Other Pre-specified|PK Substudy - Hormone Concentration Assessments (Serum Estradiol, Estrone and Estrone Conjugates; SHBG)|Blood samples will be obtained from a subset of subjects at pre-selected sites to characterize PK parameters (AUC, tmax, Cmin, Cmax, Cavg) and to measure SHBG|Pre-treatment, Day 2, Weeks 2 and 12||||||
642937|NCT02253173|Secondary|Secondary Efficacy Endpoints - Female Sexual Function Index (FSFI) Domain Score - Satisfaction|"Change from Baseline to Week 12 in FSFI Domain Score (Satisfaction) as compared to placebo
The FSFI is a brief, multidimensional questionnaire for assessing sexual function in women (Rosen et al., 2000). The questionnaire consists of 19 items that assess sexual function over the past 4 weeks and yield domain scores in six areas: sexual desire, arousal, lubrication, orgasm, satisfaction, and pain. The FSFI questionnaire has a minimum total score of 2.0, a maximum score of 36.0 points and was administered at Baseline and Week 12."|Baseline and Week 12|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 12 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.||units on a scale||95% Confidence Interval|Least Squares Mean
642938|NCT02253173|Secondary|Secondary Efficacy Endpoints - Female Sexual Function Index (FSFI) Domain Score - Pain|"Change from Baseline to Week 12 in FSFI Domain Score (Pain) as compared to placebo
The FSFI is a brief, multidimensional questionnaire for assessing sexual function in women (Rosen et al., 2000). The questionnaire consists of 19 items that assess sexual function over the past 4 weeks and yield domain scores in six areas: sexual desire, arousal, lubrication, orgasm, satisfaction, and pain. The FSFI questionnaire has a minimum total score of 2.0, a maximum score of 36.0 points and was administered at Baseline and Week 12."|Baseline and Week 12|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 12 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.||units on a scale||95% Confidence Interval|Least Squares Mean
642939|NCT02253173|Secondary|Secondary Efficacy Endpoints - Female Sexual Function Index (FSFI) Domain Score - Orgasm|"Change from Baseline to Week 12 in FSFI Domain Score (Orgasm) as compared to placebo
The FSFI is a brief, multidimensional questionnaire for assessing sexual function in women (Rosen et al., 2000). The questionnaire consists of 19 items that assess sexual function over the past 4 weeks and yield domain scores in six areas: sexual desire, arousal, lubrication, orgasm, satisfaction, and pain. The FSFI questionnaire has a minimum total score of 2.0, a maximum score of 36.0 points and was administered at Baseline and Week 12."|Baseline and Week 12|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 12 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.||units on a scale||95% Confidence Interval|Least Squares Mean
642940|NCT02253173|Secondary|Secondary Efficacy Endpoints - Female Sexual Function Index (FSFI) Domain Score - Lubrication|"Change from Baseline to Week 12 in FSFI Domain Score (Lubrication) as compared to placebo
The FSFI is a brief, multidimensional questionnaire for assessing sexual function in women (Rosen et al., 2000). The questionnaire consists of 19 items that assess sexual function over the past 4 weeks and yield domain scores in six areas: sexual desire, arousal, lubrication, orgasm, satisfaction, and pain. The FSFI questionnaire has a minimum total score of 2.0, a maximum score of 36.0 points and was administered at Baseline and Week 12."|Baseline and Week 12|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 12 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.||units on a scale||95% Confidence Interval|Least Squares Mean
642941|NCT02253173|Secondary|Secondary Efficacy Endpoints - Female Sexual Function Index (FSFI) Domain Score - Desire|"Change from Baseline to Week 12 in FSFI Domain Score (Desire) as compared to placebo
The FSFI is a brief, multidimensional questionnaire for assessing sexual function in women (Rosen et al., 2000). The questionnaire consists of 19 items that assess sexual function over the past 4 weeks and yield domain scores in six areas: sexual desire, arousal, lubrication, orgasm, satisfaction, and pain. The FSFI questionnaire has a minimum total score of 2.0, a maximum score of 36.0 points and was administered at Baseline and Week 12."|Baseline and Week 12|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 12 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.||units on a scale||95% Confidence Interval|Least Squares Mean
642982|NCT02253173|Primary|Co-Primary Efficacy Endpoint - Vaginal Parabasal Cells|• Change from Baseline to Week 12 in the percentage of vaginal parabasal cells (by vaginal cytologic smear) compared to placebo|Baseline and 12 Weeks|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 12 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.||percentage of vaginal parabasal cells||Standard Error|Least Squares Mean
642942|NCT02253173|Secondary|Secondary Efficacy Endpoints - Female Sexual Function Index (FSFI) Domain Score - Arousal|"Change from Baseline to Week 12 in FSFI Domain Score (Arousal) as compared to placebo
The FSFI is a brief, multidimensional questionnaire for assessing sexual function in women (Rosen et al., 2000). The questionnaire consists of 19 items that assess sexual function over the past 4 weeks and yield domain scores in six areas: sexual desire, arousal, lubrication, orgasm, satisfaction, and pain. The FSFI questionnaire has a minimum total score of 2.0, a maximum score of 36.0 points and was administered at Baseline and Week 12."|Baseline and Week 12|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 12 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.||units on a scale||95% Confidence Interval|Least Squares Mean
642943|NCT02253173|Secondary|Secondary Efficacy Endpoints - Female Sexual Function Index (FSFI) - Total Score|"Change from Baseline to Week 12 in FSFI Total Score as compared to placebo
The FSFI is a brief, multidimensional questionnaire for assessing sexual function in women (Rosen et al., 2000). The questionnaire consists of 19 items that assess sexual function over the past 4 weeks and yield domain scores in six areas: sexual desire, arousal, lubrication, orgasm, satisfaction, and pain. The FSFI questionnaire has a minimum total score of 2.0, a maximum score of 36.0 points and was administered at Baseline and Week 12."|Baseline and Week 12|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 12 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.||units on a scale||95% Confidence Interval|Least Squares Mean
642944|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal Mucosa Assessment (Vaginal Secretions)|"Change from Baseline to Week 12 in Vaginal Secretions as compared to placebo
Vaginal Mucosa Assessment Scale - Vaginal Secretions: No atrophy (normal clear secretions noted on vaginal walls) = 0; Mild (superficial coating of secretions, difficulty with speculum insertion) = 1; Moderate (scant not covering the entire vaginal vault, may need lubrication with speculum insertion to prevent pain) = 2; Severe (none, inflamed, ulceration noted, need lubrication with speculum insertion to prevent pain] = 3
Severity was assessed by the Investigator at Baseline and Week 12"|Baseline and Week 12|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 12 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.||units on a scale||Standard Error|Least Squares Mean
642945|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal Mucosa Assessment (Vaginal Secretions)|"Change from Baseline to Week 8 in Vaginal Secretions as compared to placebo
Vaginal Mucosa Assessment Scale - Vaginal Secretions: No atrophy (normal clear secretions noted on vaginal walls) = 0; Mild (superficial coating of secretions, difficulty with speculum insertion) = 1; Moderate (scant not covering the entire vaginal vault, may need lubrication with speculum insertion to prevent pain) = 2; Severe (none, inflamed, ulceration noted, need lubrication with speculum insertion to prevent pain] = 3
Severity was assessed by the Investigator at Baseline and Week 8"|Baseline and Week 8|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 8 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.||units on a scale||Standard Error|Least Squares Mean
642946|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal Mucosa Assessment (Vaginal Secretions)|"Change from Baseline to Week 6 in Vaginal Secretions as compared to placebo
Vaginal Mucosa Assessment Scale - Vaginal Secretions: No atrophy (normal clear secretions noted on vaginal walls) = 0; Mild (superficial coating of secretions, difficulty with speculum insertion) = 1; Moderate (scant not covering the entire vaginal vault, may need lubrication with speculum insertion to prevent pain) = 2; Severe (none, inflamed, ulceration noted, need lubrication with speculum insertion to prevent pain] = 3
Severity was assessed by the Investigator at Baseline and Week 6"|Baseline and Week 6|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 6 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.||units on a scale||Standard Error|Least Squares Mean
642947|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal Mucosa Assessment (Vaginal Secretions)|"Change from Baseline to Week 2 in Vaginal Secretions as compared to placebo
Vaginal Mucosa Assessment Scale - Vaginal Secretions: No atrophy (normal clear secretions noted on vaginal walls) = 0; Mild (superficial coating of secretions, difficulty with speculum insertion) = 1; Moderate (scant not covering the entire vaginal vault, may need lubrication with speculum insertion to prevent pain) = 2; Severe (none, inflamed, ulceration noted, need lubrication with speculum insertion to prevent pain) = 3
Severity was assessed by the Investigator at Baseline and Week 2"|Baseline and Week 2|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 2 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.||units on a scale||Standard Error|Least Squares Mean
642948|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal Mucosa Assessment (Vaginal Epithelial Surface Thickness)|"Change from Baseline to Week 12 in Vaginal Epithelial Surface Thickness as compared to placebo
Vaginal Mucosa Assessment Scale - Vaginal Epithelial Surface Thickness: No atrophy (rogation and elasticity of vault) = 0; Mild (poor rogation with some elasticity noted of vaginal vault) = 1; Moderate (smooth, some elasticity of vaginal vault) = 2; Severe [smooth, no elasticity, constriction of the upper one third of vagina or loss of vaginal tone (cystocele and rectocele)] = 3
Severity was assessed by the Investigator at Baseline and Week 12"|Baseline and Week 12|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 12 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline||units on a scale||Standard Error|Least Squares Mean
642949|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal Mucosa Assessment (Vaginal Epithelial Surface Thickness)|"Change from Baseline to Week 8 in Vaginal Epithelial Surface Thickness as compared to placebo
Vaginal Mucosa Assessment Scale - Vaginal Epithelial Surface Thickness: No atrophy (rogation and elasticity of vault) = 0; Mild (poor rogation with some elasticity noted of vaginal vault) = 1; Moderate (smooth, some elasticity of vaginal vault) = 2; Severe [smooth, no elasticity, constriction of the upper one third of vagina or loss of vaginal tone (cystocele and rectocele)] = 3
Severity was assessed by the Investigator at Baseline and Week 8"|Baseline and Week 8|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 8 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.||units on a scale||Standard Error|Least Squares Mean
642950|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal Mucosa Assessment (Vaginal Epithelial Surface Thickness)|"Change from Baseline to Week 6 in Vaginal Epithelial Surface Thickness as compared to placebo
Vaginal Mucosa Assessment Scale - Vaginal Epithelial Surface Thickness: No atrophy (rogation and elasticity of vault) = 0; Mild (poor rogation with some elasticity noted of vaginal vault) = 1; Moderate (smooth, some elasticity of vaginal vault) = 2; Severe [smooth, no elasticity, constriction of the upper one third of vagina or loss of vaginal tone (cystocele and rectocele)] = 3
Severity was assessed by the Investigator at Baseline and Week 6"|Baseline and Week 6|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 6 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline||units on a scale||Standard Error|Least Squares Mean
642951|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal Mucosa Assessment (Vaginal Epithelial Surface Thickness)|"Change from Baseline to Week 2 in Vaginal Epithelial Surface Thickness as compared to placebo
Vaginal Mucosa Assessment Scale - Vaginal Epithelial Surface Thickness: No atrophy (rogation and elasticity of vault) = 0; Mild (poor rogation with some elasticity noted of vaginal vault) = 1; Moderate (smooth, some elasticity of vaginal vault) = 2; Severe [smooth, no elasticity, constriction of the upper one third of vagina or loss of vaginal tone (cystocele and rectocele)] = 3
Severity was assessed by the Investigator at Baseline and Week 2"|Baseline and Week 2|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 2 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.||units on a scale||Standard Error|Least Squares Mean
642952|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal Mucosa Assessment (Vaginal Epithelial Integrity)|"Change from Baseline to Week 12 in Vaginal Epithelial Integrity as compared to placebo
Vaginal Mucosa Assessment Scale - Vaginal Epithelial Integrity: No atrophy (normal) = 0; Mild (vaginal surface bleeds with scraping) = 1; Moderate (vaginal surface bleeds with light contact) = 2; Severe (vaginal surface has petechiae before contact and bleeds with light contact) = 3
Severity was assessed by the Investigator at Baseline and Week 12"|Baseline and Week 12|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 12 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline||units on a scale||Standard Error|Least Squares Mean
642953|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal Mucosa Assessment (Vaginal Epithelial Integrity)|"Change from Baseline to Week 8 in Vaginal Epithelial Integrity as compared to placebo
Vaginal Mucosa Assessment Scale - Vaginal Epithelial Integrity: No atrophy (normal) = 0; Mild (vaginal surface bleeds with scraping) = 1; Moderate (vaginal surface bleeds with light contact) = 2; Severe (vaginal surface has petechiae before contact and bleeds with light contact) = 3
Severity was assessed by the Investigator at Baseline and Week 8"|Baseline and Week 8|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 8 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.||units on a scale||Standard Error|Least Squares Mean
642954|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal Mucosa Assessment (Vaginal Epithelial Integrity)|"Change from Baseline to Week 6 in Vaginal Epithelial Integrity as compared to placebo
Vaginal Mucosa Assessment Scale - Vaginal Epithelial Integrity: No atrophy (normal) = 0; Mild (vaginal surface bleeds with scraping) = 1; Moderate (vaginal surface bleeds with light contact) = 2; Severe (vaginal surface has petechiae before contact and bleeds with light contact) = 3
Severity was assessed by the Investigator at Baseline and Week 6"|Baseline and Week 6|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 6 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.||units on a scale||Standard Error|Least Squares Mean
642955|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal Mucosa Assessment (Vaginal Epithelial Integrity)|"Change from Baseline to Week 2 in Vaginal Epithelial Integrity as compared to placebo
Vaginal Mucosa Assessment Scale - Vaginal Epithelial Integrity: No atrophy (normal) = 0; Mild (vaginal surface bleeds with scraping) = 1; Moderate (vaginal surface bleeds with light contact) = 2; Severe (vaginal surface has petechiae before contact and bleeds with light contact) = 3
Severity was assessed by the Investigator at Baseline and Week 2"|Baseline and Week 2|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 2 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.||units on a scale||Standard Error|Least Squares Mean
642956|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal Mucosa Assessment (Vaginal Color)|"Change from Baseline to Week 12 in Vaginal Color as compared to placebo
Vaginal Mucosa Assessment Scale - Vaginal Color: No atrophy (pink) = 0; Mild (lighter in color) = 1; Moderate(pale in color) = 2; Severe (transparent/no color or inflamed) = 3 Severity was assessed by the Investigator at Baseline and Week 12"|Baseline and Week 12|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 12 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.||units on a scale||Standard Error|Least Squares Mean
642957|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal Mucosa Assessment (Vaginal Color)|"Change from Baseline to Week 8 in Vaginal Color as compared to placebo
Vaginal Mucosa Assessment Scale - Vaginal Color: No atrophy (pink) = 0; Mild (lighter in color) = 1; Moderate(pale in color) = 2; Severe (transparent/no color or inflamed) = 3 Severity was assessed by the Investigator at Baseline and Week 8"|Baseline to Week 8|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 8 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.||units on a scale||Standard Error|Least Squares Mean
642958|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal Mucosa Assessment (Vaginal Color)|"Change from Baseline to Week 6 in Vaginal Color as compared to placebo
Vaginal Mucosa Assessment Scale - Vaginal Color: No atrophy (pink) = 0; Mild (lighter in color) = 1; Moderate(pale in color) = 2; Severe (transparent/no color or inflamed) = 3 Severity was assessed by the Investigator at Baseline and Week 6"|Baseline to Week 6|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 6 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.||units on a scale||Standard Error|Least Squares Mean
646404|NCT02146352|Secondary|Clinical Success Outcome Measure|Clinical success: At least a 50% decrease in pseudocyst size at 30 days or 60 days|30 or 60 days post-procedure|Entire patient cohort||percentage of patients|||Number
642959|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal Mucosa Assessment (Vaginal Color)|"Change from Baseline to Week 2 in Vaginal Color as compared to placebo
Vaginal Mucosa Assessment Scale - Vaginal Color: No atrophy (pink) = 0; Mild (lighter in color) = 1; Moderate(pale in color) = 2; Severe (transparent/no color or inflamed) = 3 Severity was assessed by the Investigator at Baseline and Week 2"|Baseline and Week 2|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 2 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.||units on a scale||Standard Error|Least Squares Mean
642960|NCT02253173|Secondary|Secondary Efficacy Endpoints - Other VVA Symptoms (Vulvar and/or Vaginal Itching or Irritation)|"Change from Baseline to Week 12 on the severity of vulvar and/or vaginal itching or irritation associated with VVA as compared to placebo
VVA Symptoms Self-Assessment Questionnaire Severity Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe.
Subjects assessed severity at Baseline and Week 12"|Baseline and Week 12|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 12 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.||units on a scale||Standard Error|Least Squares Mean
642961|NCT02253173|Secondary|Secondary Efficacy Endpoints - Other VVA Symptoms (Vulvar and/or Vaginal Itching or Irritation)|"Change from Baseline to Week 8 on the severity of vulvar and/or vaginal itching or irritation associated with VVA as compared to placebo
VVA Symptoms Self-Assessment Questionnaire Severity Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe.
Subjects assessed severity at Baseline and Week 8"|Baseline and Week 8|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 8 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.||units on a scale||Standard Error|Least Squares Mean
642962|NCT02253173|Secondary|Secondary Efficacy Endpoints - Other VVA Symptoms (Vulvar and/or Vaginal Itching or Irritation)|"Change from Baseline to Week 6 on the severity of vulvar and/or vaginal itching or irritation associated with VVA as compared to placebo
VVA Symptoms Self-Assessment Questionnaire Severity Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe.
Subjects assessed severity at Baseline and Week 6"|Baseline and Week 6|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 6 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.||units on a scale||Standard Error|Least Squares Mean
642963|NCT02253173|Secondary|Secondary Efficacy Endpoints - Other VVA Symptoms (Vulvar and/or Vaginal Itching or Irritation)|"Change from Baseline to Week 2 on the severity of vulvar and/or vaginal itching or irritation associated with VVA as compared to placebo
VVA Symptoms Self-Assessment Questionnaire Severity Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe.
Subjects assessed severity at Baseline and Week 2"|Baseline and Week 2|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 2 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.||units on a scale||Standard Error|Least Squares Mean
642964|NCT02253173|Secondary|Secondary Efficacy Endpoints - Severity of Other VVA Symptoms (Vaginal Dryness)|"Change from Baseline to Week 12 on the severity of vaginal dryness associated with VVA as compared to placebo
VVA Symptoms Self-Assessment Questionnaire Severity Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe.
Subjects assessed severity at Baseline and Week 12"|Baseline and Week 12|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 12 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.||units on a scale||Standard Error|Least Squares Mean
642965|NCT02253173|Secondary|Secondary Efficacy Endpoints - Severity of Other VVA Symptoms (Vaginal Dryness)|"Change from Baseline to Week 8 on the severity of vaginal dryness associated with VVA as compared to placebo
VVA Symptoms Self-Assessment Questionnaire Severity Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe.
Subjects assessed severity at Baseline and Week 8"|Baseline and Week 8|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 8 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.||units on a scale||Standard Error|Least Squares Mean
642966|NCT02253173|Secondary|Secondary Efficacy Endpoints - Severity of Other VVA Symptoms (Vaginal Dryness)|"Change from Baseline to Week 6 on the severity of vaginal dryness associated with VVA as compared to placebo
VVA Symptoms Self-Assessment Questionnaire Severity Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe.
Subjects assessed severity at Baseline and Week 6"|Baseline and Week 6|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 6 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.||units on a scale||Standard Error|Least Squares Mean
642967|NCT02253173|Secondary|Secondary Efficacy Endpoints - Severity of Other VVA Symptoms (Vaginal Dryness)|"Change from Baseline to Week 2 on the severity of vaginal dryness associated with VVA as compared to placebo
VVA Symptoms Self-Assessment Questionnaire Severity Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe.
Subjects assessed severity at Baseline and Week 2"|Baseline and Week 2|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 2 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.||units on a scale||Standard Error|Least Squares Mean
642968|NCT02253173|Secondary|Secondary Efficacy Endpoints - Severity of Most Bothersome Symptom (Dyspareunia)|"Change from Baseline to Week 8 on the severity of the MBS of dyspareunia (vaginal pain associated with sexual activity) associated with VVA as compared to placebo
VVA Symptoms Self-Assessment Questionnaire Severity Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe.
Subjects assessed severity at Baseline and Week 8"|Baseline and Week 8|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 8 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.||units on a scale||Standard Error|Least Squares Mean
642983|NCT02253173|Primary|Co-Primary Efficacy Endpoint - Vaginal Superficial Cells|• Change from Baseline to Week 12 in the percentage of vaginal superficial cells (by vaginal cytologic smear) compared to placebo|Baseline and 12 Weeks|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 12 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.||percentage of vaginal superficial cells||Standard Error|Least Squares Mean
642969|NCT02253173|Secondary|Secondary Efficacy Endpoints - Severity of Most Bothersome Symptom (Dyspareunia)|"Change from Baseline to Week 6 on the severity of the MBS of dyspareunia (vaginal pain associated with sexual activity) associated with VVA as compared to placebo
VVA Symptoms Self-Assessment Questionnaire Severity Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe.
Subjects assessed severity at Baseline and Week 6"|Baseline and Week 6|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 6 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.||units on a scale||Standard Error|Least Squares Mean
642970|NCT02253173|Secondary|Secondary Efficacy Endpoints - Severity of Most Bothersome Symptom (Dyspareunia)|"Change from Baseline to Week 2 on the severity of the MBS of dyspareunia (vaginal pain associated with sexual activity) associated with VVA as compared to placebo
VVA Symptoms Self-Assessment Questionnaire Severity Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe.
Subjects assessed severity at Baseline and Week 2"|Baseline and Week 2|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 2 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.||units on a scale||Standard Error|Least Squares Mean
642971|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal pH|Change from Baseline to Week 8 in vaginal pH as compared to placebo|Baseline and Week 8|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 8 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.||pH units||Standard Error|Least Squares Mean
642972|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal pH|Change from Baseline to Week 6 in vaginal pH as compared to placebo|Baseline and Week 6|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 6 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.||pH units||Standard Error|Least Squares Mean
642973|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal pH|Change from Baseline to Week 2 in vaginal pH as compared to placebo|Baseline and Week 2|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 2 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.||pH units||Standard Error|Least Squares Mean
642974|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal Parabasal Cells|Change from Baseline to Week 8 in the percentage of vaginal parabasal cells (by vaginal cytologic smear) compared to placebo|Baseline and Week 8|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 8 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.||percentage of vaginal parabasal cells||Standard Error|Least Squares Mean
642975|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal Parabasal Cells|Change from Baseline to Week 6 in the percentage of vaginal parabasal cells (by vaginal cytologic smear) compared to placebo|Baseline and Week 6|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 6 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.||percentage of vaginal parabasal cells||Standard Error|Least Squares Mean
642976|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal Parabasal Cells|Change from Baseline to Week 2 in the percentage of vaginal parabasal cells (by vaginal cytologic smear) compared to placebo|Baseline and Week 2|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 2 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.||percentage of vaginal parabasal cells||Standard Error|Least Squares Mean
642977|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal Superficial Cells|Change from Baseline to Week 8 in the percentage of vaginal superficial cells (by vaginal cytologic smear) compared to placebo|Baseline and Week 8|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 8 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.||percentage of vaginal superficial cells||Standard Error|Least Squares Mean
642978|NCT02253173|Secondary|Secondary Efficacy Endpoints- Vaginal Superficial Cells|Change from Baseline to Week 6 in the percentage of vaginal superficial cells (by vaginal cytologic smear) compared to placebo|Baseline and Week 6|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 6 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.||percentage of vaginal superficial cells||Standard Error|Least Squares Mean
642979|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal Superficial Cells|• Change from Baseline to Week 2 in the percentage of vaginal superficial cells (by vaginal cytologic smear) compared to placebo|Baseline and Week 2|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 2 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.||percentage of vaginal superficial cells||Standard Error|Least Squares Mean
642980|NCT02253173|Primary|Co-Primary Efficacy Endpoint - Severity of Most Bothersome Symptom (Dyspareunia)|"• Change from Baseline to Week 12 on the severity of the MBS of dyspareunia (vaginal pain associated with sexual activity) associated with VVA as compared to placebo
VVA Symptoms Self-Assessment Questionnaire Severity Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe.
Subjects assessed severity at Baseline and Week 12"|Baseline and Week 12|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 12 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.||units on a scale||Standard Error|Least Squares Mean
642981|NCT02253173|Primary|Co-Primary Efficacy Endpoint - Vaginal pH|• Change from Baseline to Week 12 in vaginal pH as compared to placebo|Baseline and 12 Weeks|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 12 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.||pH units||Standard Error|Least Squares Mean
642984|NCT02253160|Secondary|MNC Product Contamination/Purity - RBC Concentration (10^6/µL)||within 5 minutes upon completion of procedure|||RBC*10^6/µL||Standard Deviation|Mean
644901|NCT02196714|Secondary|Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose|Change in Mean Chemistry Parameters (±SD) from Pre-dose to 12 Hours Post-dose (eGFR)|12 hours|Safety Population||mL/min/1.73m2||Standard Deviation|Mean
642985|NCT02253160|Secondary|MNC Collection Efficiency (CE2%)|Comparison of collection efficiencies associated with the CMNC Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems for MNCs. CE2 is a measurement of device performance calculated using donor blood counts immediately before and blood product counts immediately after the collection procedure and does not average the donor pre- and post-collection counts. The collection efficiency for a given cell type is defined as the percent of processed cells of that cell type that are in fact collected.|within 5 minutes upon completion of procedure|||percent||Standard Deviation|Mean
642986|NCT02253160|Other Pre-specified|Post-collection Platelet Loss in Subject|The percent change from pre-collection platelet count to post-collection subject platelet count.|24-hours after last collection procedure|||percent change||Standard Deviation|Mean
642987|NCT02253160|Other Pre-specified|Device Deficiencies|Any time a device or disposable does not function as described in the Operator’s Manual or Package Insert, a Device Deficiency must be reported. This includes those instances wherein Operator Error led to a malfunction/deficiency. A device deficiency is any inadequacy in the identity, quality, durability, reliability, safety or performance of an investigational device, including malfunction, use errors or inadequacy in the information supplied by the manufacturer. Device malfunctions and device incidents should be reported in the same manner.|24-hours after last collection procedure|All pivotal subjects (n=22) received both the Spectra Optia and the COBE Spectra per the crossover design. The lead-in subject only received the Spectra Optia. Both lead-in and pivotal subjects are included in any safety analysis.||events|||Number
642988|NCT02253160|Secondary|Procedure Time (Minutes)||within 5 minutes upon completion of procedure|||minutes||Standard Deviation|Mean
642989|NCT02253160|Secondary|Purity of Plasma Collected for Laboratory Processing of MNC Product - Platelet Concentration in Plasma (10^3/µL)|A small amount of plasma typically used for processing was collected in a sub-set of collection procedures.|within 5 minutes upon completion of procedure|Five collections also collected plasma for this sub-study.||cells*10^3/µL||Standard Deviation|Mean
642990|NCT02253160|Secondary|MNC Blood Product Volume (mL)|The produced unit of MNCs collected into the blood bag.|within 5 minutes upon completion of procedure|||mL||Standard Deviation|Mean
642991|NCT02253160|Secondary|MNC Product Contamination/Purity (%) - Platelet Collection Efficiency (CE1 %)|Comparison of collection efficiencies associated with the CMNC Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems for platelets. CE1 is a measurement of device performance calculated using donor and blood product blood counts collected immediately before and after the collection procedure. The collection efficiency for a given cell type is defined as the percent of processed cells of that cell type that are in fact collected.|within 5 minutes upon completion of procedure|One subject was not included in MNC CE1 because of missing MNC lab results post-collection, therefore CE1 could not be calculated.||percent||Standard Deviation|Mean
642992|NCT02253160|Secondary|MNC Product Contamination/Purity (%) - Platelet Concentration (10^3/µL)||within 5 minutes upon completion of procedure|||cells*10^3/µL||Standard Deviation|Mean
642993|NCT02253160|Secondary|MNC Product Contamination/Purity (%) - Granulocyte Concentration (10^3/mL)||within 5 minutes upon completion of procedure|||cells*10^3/mL||Standard Deviation|Mean
642994|NCT02253160|Secondary|MNC Product Contamination/Purity (%) - Hematocrit (%)||within 5 minutes upon completion of procedure|||% of red blood cells||Standard Deviation|Mean
642995|NCT02253160|Secondary|CD34+ Per kg of Body Weight||within 5 minutes upon completion of procedure|||cells/kg||Standard Deviation|Mean
642996|NCT02253160|Secondary|MNC Collection Efficiency (CE1%)|Comparison of collection efficiencies associated with the CMNC Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems for MNCs. CE1 is a measurement of device performance calculated using donor and blood product blood counts collected immediately before and after the collection procedure. The collection efficiency for a given cell type is defined as the percent of processed cells of that cell type that are in fact collected.|within 5 minutes upon completion of procedure|One subject was not included in MNC CE1 because of missing MNC lab results post-collection, therefore CE1 could not be calculated.||percent||Standard Deviation|Mean
642997|NCT02253160|Secondary|CD34+ Collection Efficiency (CE2 %)|Comparison of collection efficiencies associated with the CMNC Cell Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems. CE is a measurement of device performance calculated using donor blood counts immediately before and blood product blood counts immediately after the collection procedure. The collection efficiency for a given cell type is defined as the percent of processed cells of that cell type that are in fact collected.|within 5 minutes upon completion of procedure|||percent||Standard Deviation|Mean
642998|NCT02253160|Primary|CD34+ Collection Efficiency (CE1 %)|The primary endpoint is the CD34+ cell collection efficiency (CE) associated with the Mononuclear Cell (CMNC) Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems. CE is a measurement of device performance calculated using donor and blood product blood counts collected immediately before and after the CMNC collection procedure. The collection efficiency for a given cell type is defined as the percent of processed cells of that cell type that are in fact collected.|within 5 minutes upon completion of procedure|||percent||Standard Deviation|Mean
642999|NCT02252016|Secondary|Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Completing Study Therapy (SVR24)|The percentage of participants in both arms achieving SVR24 (i.e., HCV RNA level below the LLoQ 24 weeks after completing study therapy) was determined. HCV RNA levels were measured using the Roche COBAS™ Taqman™ HCV Test v2.0 (High Pure System), which has a LLoQ of <15 IU/mL.|24 weeks after completing study therapy (Week 36)|The FAS consists of all treated participants in both arms other than those who discontinued with reasons unrelated to the treatment regimen or HCV response.||Percentage of participants||95% Confidence Interval|Number
643000|NCT02252016|Primary|Percentage of Participants Discontinuing From Study Treatment Due to an AE(s)|An AE is any untoward medical occurrence which does not necessarily have to have a causal relationship with this treatment.|Up to Week 12|The APaT population includes all participants receiving ≥1 dose(s) of study drug. For the Deferred Treatment arm, data indicate results obtained during the initial 12-week placebo treatment period.||Percentage of Participants|||Number
643035|NCT02252354|Primary|Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 1 Post-dose|Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.|Hour 1 post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||percentage of dose|||Number
643001|NCT02252016|Primary|Percentage of Participants Experiencing an Adverse Event (AE)|An AE is any untoward medical occurrence which does not necessarily have to have a causal relationship with this treatment.|Up to Week 14|The All-Participants-as-Treated (APaT) population includes all participants receiving ≥1 dose(s) of study drug. For the Deferred Treatment arm, data indicate results obtained during the initial 12-week placebo treatment period.||Percentage of Participants|||Number
643002|NCT02252016|Primary|Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After Completing Study Therapy (SVR12)|The percentage of participants in the both arms achieving SVR12 (i.e., HCV riboncleic acid [RNA] level below the lower limit of quantification [LLoQ] 12 weeks after completing study therapy) was determined. HCV RNA levels were measured using the Roche COBAS™ Taqman™ HCV Test v2.0 (High Pure System), which has a LLoQ of <15 IU/mL.|12 weeks after completing study therapy (Week 24)|The Full Analysis Set (FAS) consists of all treated participants in both arms other than those who discontinued with reasons unrelated to the treatment regimen or HCV response.||Percentage of participants||95% Confidence Interval|Number
643003|NCT02252965|Secondary|Percentage of Subjects Who Are Compliant to Treatment|Compliance was defined as not skipping or forgetting dosing or not delaying the dosing time. Subjects who never missed a dose of medication were considered compliant.|Baseline up to Week 16|The safety population included all subjects who received at least 1 dose of trial treatment.||percentage of subjects|||Number
643004|NCT02252965|Secondary|Percentage of Subjects With HbA1c Less Than (<) 7% and With no Severe Gastrointestinal (GI) and Other Adverse Events (AEs)|Percentage of subjects with HbA1c <7% and with no severe GI and other AEs were reported. Severe adverse events were based on Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 and were defined as those events which were medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living (ADL). Self-care ADL refer to bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden.|Baseline up to Week 16|ITT population included all subjects who were randomly allocated to a treatment based on the intention to treat.||percentage of subjects||95% Confidence Interval|Number
643005|NCT02252965|Secondary|Percentage of Subjects Who Are Totally Intolerant to the Treatment|Subjects were considered to be totally intolerant if they experienced a Grade 3 or higher toxicity considered at least possibly related to the treatment.|Baseline up to Week 16|The safety population included all subjects who received at least 1 dose of trial treatment.||percentage of subjects||95% Confidence Interval|Number
643006|NCT02252965|Secondary|Percentage of Subjects With HbA1c Less Than (<) 7%||Baseline up to Week 16|ITT population included all subjects who were randomly allocated to a treatment based on the intention to treat.||percentage of subjects||95% Confidence Interval|Number
643007|NCT02252965|Secondary|Percentage of Subjects With Marked Hyperglycemia|Marked hyperglycemia was defined as the FPG level of greater than or equal to 11.1 mmol/L.|Baseline up to Week 16|ITT population included all subjects who were randomly allocated to a treatment based on the intention to treat.||percentage of subjects||95% Confidence Interval|Number
643008|NCT02252965|Secondary|Percentage of Subjects With Hypoglycemia|Hypoglycemia, also called as low blood glucose or low blood sugar, is defined as the blood glucose level of less than normal (that is less than 3.9 millimole per liter [mmol/L]).|Baseline up to Week 16|The safety population included all subjects who received at least 1 dose of trial treatment.||percentage of subjects||95% Confidence Interval|Number
643009|NCT02252965|Secondary|Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) Level at Weeks 8 and 16|The 2-hour Postprandial plasma glucose (PPG) level refers to the plasma glucose concentrations after 2 hours of eating.|Baseline, Week 8 and 16|ITT population included all subjects who were randomly allocated to a treatment based on the intention to treat. Here “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure. Here “n” signifies those subjects who were evaluable for the specified time points for each arm, respectively.||mmol/L||Standard Deviation|Mean
643010|NCT02252965|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) Level at Week 1, 2, 4, 8, 12 and 16||Baseline, Week 1, 2, 4, 8, 12,16|ITT population included all subjects who were randomly allocated to a treatment based on the intention to treat. Here “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure. Here “n” signifies those subjects who were evaluable for the specified time points for each arm, respectively.||Millimole Per Liter (mmol/L)||Standard Deviation|Mean
643011|NCT02252965|Secondary|Percentage of Subjects With Pre-specified Gastrointestinal Adverse Events During Treatment Period|An adverse event (AE) was defined as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. Number of subjects with pre-specified gastrointestinal adverse events (diarrhea, nausea, abdominal pain, bloating, constipation, dyspepsia and flatulence) were reported.|Baseline up to Week 16|The safety population included all subjects who received at least 1 dose of trial treatment.||percentage of subjects||95% Confidence Interval|Number
643012|NCT02252965|Primary|Overall Gastrointestinal (GI) Tolerability Assessed as Percentage of Subjects With Gastrointestinal Adverse Events During Treatment Period|An adverse event (AE) was defined as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to the medicinal product.|Baseline up to Week 16|The safety population included all subjects who received at least 1 dose of trial treatment.||percentage of subjects||95% Confidence Interval|Number
643013|NCT02252965|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 16||Baseline, Week 16|"Per-protocol (PP) population included all subjects who were randomly allocated to a treatment based on intent to treat and were compliant with protocol (absence of any major protocol violations). Here Number of Participants Analyzed signifies those subjects who were evaluable for this outcome measure."||Percentage of HbA1c||Standard Error|Least Squares Mean
643014|NCT02252744|Primary|Number of Participants Diagnosed With Rheumatoid Arthritis Also Found to Have Dry Eye Disease||1 day|||participants|||Number
644902|NCT02196714|Secondary|Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose|Change in Mean Chemistry Parameters (±SD) from Pre-dose to 12 Hours Post-dose|12 hours|Safety Population||μmol/L||Standard Deviation|Mean
643015|NCT02252718|Primary|Interrater Variability (IV)|The outcome measures were interrater variability in the stool assessment by the parent and MD1 made in vivo and in the assessment by the parent in vivo and by MD2 based on the photograph(s). The IV was evaluated by calculating the proportion of exact agreement and the κ statistics for nominal data (colour) and weighted κ values for items in which there is a natural ordering of categories (consistency and amount). Correlation, based on the value of kappa (κ), was categorized as poor (κ ≤ 0.2), fair (0.21 ≤ κ ≤ 0.40), moderate (0.41 ≤ κ ≤ 0.60), good (0.61 ≤ κ ≤ 0.80) or excellent (0.81 ≤ κ ≤ 1.00).|<5min after defecation|||kappa value||95% Confidence Interval|Number
643016|NCT02252445|Secondary|Analgesics|The amount of analgesics will be measured at 0, 1, 6 and 24 hour postoperatively.|0, 1, 6 and 24 hour postoperatively|Patients infused with tramadol were counted.||participants|||Number
643017|NCT02252445|Secondary|Dizziness|Dizziness will be measured at 0, 1, 6 and 24 hour postoperatively.|0, 1, 6 and 24 hour postoperatively|Patients with dizziness were counted.||participants|||Number
643018|NCT02252445|Secondary|Blurred Vision|Blurred vision will be measured at 0, 1, 6 and 24 hour postoperatively.|0, 1, 6 and 24 hour postoperatively|Patients with blurred vision were counted.||participants|||Number
643019|NCT02252445|Secondary|Flushing|Flushing will be measured at 0, 1, 6 and 24 hour postoperatively.|0, 1, 6 and 24 hour postoperatively|Patients with flushing were counted.||participants|||Number
643020|NCT02252445|Secondary|Dry Mouth|Dry mouth will be measured at 0, 1, 6 and 24 hour postoperatively.|0, 1, 6 and 24 hour postoperatively|Patients with dry mouth were counted.||participants|||Number
643021|NCT02252445|Secondary|Vomiting|Vomiting will be measured at 0, 1, 6 and 24 hour postoperatively.|0, 1, 6 and 24 hour postoperatively|Patients with vomiting were counted.||participants|||Number
643022|NCT02252445|Secondary|Nausea|Nausea will be measured at 0, 1, 6 and 24 hour postoperatively.|0, 1, 6 and 24 hour postoperatively|Patients with nausea were counted.||participants|||Number
643023|NCT02252445|Secondary|Hemodynamic Parameters|Mean blood pressure and heart rate will be measured at 0, 1, 5, 10 minute postoperatively. Measurement at 10 minute means Mean blood pressure and heart rate at the admission of post-anesthetic care unit.|0, 1, 5, 10 minute postoperatively|||mmHg||Standard Deviation|Mean
643024|NCT02252445|Secondary|Catheter-related Bladder Discomfort|Catheter-related bladder discomfort will be measured at 1 hour postoperatively (0:none, 1:mild, 2:moderate, 3:severe). Patients with score >0 will be counted.|0, 6 and 24 hour postoperatively|Patients with score >0 will be counted.||participants|||Number
643025|NCT02252445|Primary|Catheter-related Bladder Discomfort|Catheter-related bladder discomfort will be measured at 1 hour postoperatively (0:none, 1:mild, 2:moderate, 3:severe). Patients with score >0 will be counted.|1 hour postoperatively|Patients with score >0 were counted.||participants|||Number
643026|NCT02252354|Secondary|Part 2: Clearance (CL) for [14C]-TAK-385|CL is clearance of the drug from the plasma, calculated as the drug dose divided by AUC expressed in L/hr. CL is a quantitative measure of the rate at which a drug substance is removed from the body. Radioactivity corresponds to NMT 37.0 kBq (1000 nCi).|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||L/hr||Standard Deviation|Mean
643027|NCT02252354|Primary|Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 72 Post-dose|Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.|Hour 72 post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||percentage of dose|||Number
643028|NCT02252354|Primary|Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 48 Post-dose|Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.|Hour 48 post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||percentage of dose|||Number
643029|NCT02252354|Primary|Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 36 Post-dose|Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.|Hour 36 post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||percentage of dose|||Number
643030|NCT02252354|Primary|Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 24 Post-dose|Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.|Hour 24 post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||percentage of dose|||Number
643031|NCT02252354|Primary|Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 12 Post-dose|Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.|Hour 12 post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||percentage of dose|||Number
643032|NCT02252354|Primary|Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 8 Post-dose|Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.|Hour 8 post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||percentage of dose|||Number
643033|NCT02252354|Primary|Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 4 Post-dose|Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.|Hour 4 post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||percentage of dose|||Number
643034|NCT02252354|Primary|Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 2 Post-dose|Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.|Hour 2 post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||percentage of dose|||Number
644903|NCT02196714|Secondary|Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose|Change in Mean Chemistry Parameters (±SD) from Pre-dose to 12 Hours Post-dose|12 hours|Safety Population||mmol/L||Standard Deviation|Mean
643036|NCT02252354|Primary|Part 1: Excretion of TAK-385 and Its Metabolites in Human Urine as Percentage of Dose|Amount of total [14]C, TAK-385, metabolite A, B, and C, and others excreted from urine, calculated as percentage of dose. Others were calculated by subtraction of the sum of the values for TAK-385, Metabolite-A, Metabolite-B, and Metabolite-C from the value of the total [14]C.|0 to 144 hours post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||percentage of dose||Standard Deviation|Mean
643037|NCT02252354|Primary|Part 1: Excretion of TAK-385 and Its Metabolites in Human Feces as Percentage of Dose|Amount of total [14]C, TAK-385, metabolite A, B, and C, and others excreted from feces, calculated as percentage of dose. Others were calculated by subtraction of the sum of the values for TAK-385, Metabolite-A, Metabolite-B, and Metabolite-C from the value of the total [14]C.|0 to 191 hours post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||percentage of dose||Standard Deviation|Mean
643038|NCT02252354|Primary|Part 1: Excretion of TAK-385 and Its Metabolites in Human Urine as Percent Radioactivity|Amount of total [14]C, TAK-385, metabolite A, B, and C, and others excreted from urine, calculated as percentage of recovered radioactivity, are reported. Others were calculated by subtraction of the sum of the values for TAK-385, Metabolite-A, Metabolite-B, and Metabolite-C from the value of the total radioactivity (total [14]C).Radioactivity corresponds to NMT 4.7 MBq (127 mCi).|0 to 144 hours post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||percentage of recovered radioactivity||Standard Deviation|Mean
643039|NCT02252354|Primary|Part 1: Excretion of TAK-385 and Its Metabolites in Human Feces as Percent Radioactivity|Amount of total [14]C, TAK-385, metabolite A, B, and C, and others excreted from feces, calculated as percentage of recovered radioactivity, are reported. Others were calculated by subtraction of the sum of the values for TAK-385, Metabolite-A, Metabolite-B, and Metabolite-C from the value of the total radioactivity (total [14]C).Radioactivity corresponds to NMT 4.7 MBq (127 mCi).|0 to 191 hours post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||percentage of recovered radioactivity||Standard Deviation|Mean
643040|NCT02252354|Secondary|Part 2: Overall Cumulative Percent Recovery of Total Dosed Radioactivity in Urine and Feces|Overall cumulative percent of radioactive dose recovered in urine and feces is the total radioactivity excreted in urine and feces divided by the amount of total radioactivity dosed for each participant.|Day 1 pre-dose and various time-points (up to 72 hours) post-dose for urine; Day 1 pre-dose and various time-points (up to 48 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||percent recovery of radioactivity||Standard Deviation|Mean
643041|NCT02252354|Secondary|Part 2: Volume of Distribution (Vz/F) for TAK-385|Vz/F is the distribution of a drug between plasma and the rest of the body following oral administration, calculated as CL/F divided by the terminal elimination rate constant (λz).|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||L||Standard Deviation|Mean
643042|NCT02252354|Secondary|Part 1: Volume of Distribution (Vz/F) for TAK-385|Vz/F is the distribution of a drug between plasma and the rest of the body following oral administration, calculated as CL/F divided by the terminal elimination rate constant (λz). Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product.|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||Liter (L)||Standard Deviation|Mean
643043|NCT02252354|Secondary|Part 2: Apparent Oral Clearance (CL/F) for TAK-385|CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided by AUC expressed in liters/hour (L/hr).CL which was calculated by correcting the [14C]TAK-385 AUC, following the intravenous dose with the hamilton pool result to get a true CL (L/h).|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||L/hr||Standard Deviation|Mean
643044|NCT02252354|Secondary|Part 1: Apparent Oral Clearance (CL/F) for TAK-385|CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided by AUC expressed in liters/hour (L/hr). CL which was calculated by correcting the [14C]TAK-385 AUC, following the intravenous dose with the hamilton pool result to get a true CL (L/h). Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product.|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||L/hr||Standard Deviation|Mean
643045|NCT02252354|Primary|Part 2: Absolute Bioavailability for the Oral Tablet Formulation|Absolute bioavailability, defined as the fraction or percentage of the unchanged, orally administered dose that is systemically available, relative to the total dose administered intravenously. AUC was corrected using the Hamilton Pool Data to get an AUC for TAK-385|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||percentage bioavailability||Standard Deviation|Mean
643046|NCT02252354|Primary|Part 2: Terminal Phase Elimination Half-Life (t1/2z) in Plasma for TAK-385|Terminal phase elimination half-life (t1/2z) is the time required for half of the drug to be eliminated from the blood.|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||hours||Standard Deviation|Mean
643047|NCT02252354|Primary|Part 2: Terminal Phase Elimination Half-Life (t1/2z) in Plasma Radioactivity for [14C]-TAK-385|Terminal phase elimination half-life (t1/2z) is the time required for half of the drug to be eliminated from the blood. Radioactivity corresponds to NMT 37.0 kBq (1000 nCi).Total radioactivity and [14C]-TAK-385 determination of plasma samples was determined by AMS.|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||hours||Standard Deviation|Mean
643087|NCT02250703|Secondary|Wake up Behavior|"assessed in post anesthesia recovery unit after the procedure on a scale of 1o 4
calm
not calm but easily calmed
moderately agitated or restless
combative/disoriented 1 and 2 are considered satisfactory 3 and 4 are considered unsatisfactory"|Day 0: At the end of surgery when the patient recovers from anesthesia|||Participants|||Count of Participants
643048|NCT02252354|Primary|Part 2: AUC(0-168): Area Under the Plasma Concentration-Time Curve From Time 0 to 168 Hours Postdose for TAK-385|AUC(0-168) is measure of area under the curve over the dosing interval (tau),where tau is the length of the dosing interval: 168 hours in this study (AUC(0-tau]). AUC was corrected using the Hamilton Pool Data to get an AUC for TAK-385.|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||ng*hr/mL||Standard Deviation|Geometric Mean
643049|NCT02252354|Primary|Part 2: AUC(0-168): Area Under the Plasma Radioactivity Concentration-Time Curve From Time 0 to 168 Hours Postdose for [14C]-TAK-385|AUC(0-168) is measure of area under the curve over the dosing interval (tau), where tau is the length of the dosing interval :168 hours in this study (AUC(0-tau]). AUC(0-168) was corrected according to Hamilton Pool result.Radioactivity corresponds to NMT 37.0 kBq (1000 nCi).Total radioactivity and [14C]-TAK-385 determination of plasma samples was determined by AMS.|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||ng eq*hr/mL||Standard Deviation|Geometric Mean
643050|NCT02252354|Primary|Part 2: AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-385|AUC(0-inf) is measure of area under the curve from time 0 to Infinity.|Day 1 pre-dose and various time-points (up to 288 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||ng*hr/mL||Standard Deviation|Geometric Mean
643051|NCT02252354|Primary|Part 2: AUC(0-inf): Area Under the Plasma Radioactivity Concentration-time Curve From Time 0 to Infinity for [14C]-TAK-385|AUC(0-inf) is measure of area under the curve from time 0 to Infinity. Radioactivity corresponds to NMT 37.0 kBq (1000 nCi).AUC(0-inf) was corrected according to Hamilton Pool result.Total radioactivity and [14C]-TAK-385 determination of plasma samples was determined by AMS.|Day 1 pre-dose and various sampling time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||ng eq*hr/mL||Standard Deviation|Geometric Mean
643052|NCT02252354|Primary|Part 2: Cmax: Maximum Observed Plasma Radioactivity Concentration for TAK-385|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||ng/mL||Standard Deviation|Geometric Mean
643053|NCT02252354|Primary|Part 2: Cmax: Maximum Observed Plasma Radioactivity Concentration for [14C]-TAK-385|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. Radioactivity corresponds to NMT 37.0 kBq (1000 nCi).Total radioactivity and [14C]-TAK-385 determination of plasma samples was determined by AMS.|Day 1 pre-dose and various time-points (up to 168hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||ng eq/mL||Standard Deviation|Geometric Mean
643054|NCT02252354|Primary|Part 2: Tmax : Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-385|Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||hours||Full Range|Median
643055|NCT02252354|Primary|Part 2: Tmax : Time to Reach the Maximum Plasma Radioactivity Concentration (Cmax) for [14C]-TAK-385|Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax. Radioactivity corresponds to NMT 37.0 kilobecquerel (kBq) (1000 nanocurie [nCi]). Total radioactivity and [14C]-TAK-385 determination of plasma samples was determined by AMS.|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||hours||Full Range|Median
643056|NCT02252354|Primary|Part 1: Overall Cumulative Percent Recovery of Total Dosed Radioactivity in Urine and Feces|Overall cumulative percent of radioactive dose recovered in urine and feces is the total radioactivity excreted in urine and feces divided by the amount of total radioactivity dosed for each participant. Total [14-C] determination of urine and feces samples were determined by Liquid Scintillation Counting (LSC).|Day 1 pre-dose and various time-points (up to Day 288) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||percent recovery of radioactivity||Standard Deviation|Mean
643057|NCT02252354|Primary|Part 1: Terminal Phase Elimination Half-Life (t1/2z) in Plasma for TAK-385|Terminal phase elimination half-life (t1/2z) is the time required for half of the drug to be eliminated from the blood. Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product ([14C]-TAK-385).|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||hours||Standard Deviation|Mean
643058|NCT02252354|Primary|Part 1: Terminal Phase Elimination Half-Life (t1/2z) in Plasma and Whole Blood Radioactivity for [14C]-TAK-385|Terminal phase elimination half-life (t1/2z) is the time required for half of the drug to be eliminated from the blood. Radioactivity corresponds to NMT 4.7 MBq (127 mCi). It was calculated as disintegration per minute per mL (DPM/mL). Total [14C]-TAK-385 determination of plasma and whole blood samples was determined by AMS method.|Day 1 pre-dose and various time-points (up to 288 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||hours||Standard Deviation|Mean
643059|NCT02252354|Primary|Part 1: AUC(0-168): Area Under the Plasma Concentration-Time Curve From Time 0 to 168 Hours Postdose for TAK-385|AUC(0-168) is measure of area under the curve over the dosing interval (tau) (AUC(0-tau]), where tau is the length of the dosing interval -168 hours in this study). Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product ([14C]-TAK-385).|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||ng*hr/mL||Standard Deviation|Geometric Mean
643720|NCT02229864|Secondary|Number of Subjects With All Target Lesion Revascularization (TLR)|All target lesion revascularization includes ischemia-driven target lesion revascularization (ID-TLR) and non ischemia-driven target lesion revascularization (NID-TLR).|≤ 7 days post index procedure (In-hospital )|||Participants|||Count of Participants
643060|NCT02252354|Primary|Part 1: AUC(0-168): Area Under the Plasma and Whole Blood Radioactivity Concentration-Time Curve From Time 0 to 168 Hours Postdose for [14C]-TAK-385|AUC(0-168) is measure of area under the curve over the dosing interval (tau),where tau is the length of the dosing interval: 168 hours in this study (AUC(0-168]). Radioactivity corresponds to NMT 4.7 MBq (127 mCi). It was calculated as disintegration per minute per mL (DPM/mL). Total [14C]-TAK-385 determination of plasma and whole blood samples was determined by AMS method.|Day 1 pre-dose and various time-points (up to 288 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||ng eq*hr/mL||Standard Deviation|Geometric Mean
643061|NCT02252354|Primary|Part 1: AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-385|AUC(0-inf) is area under the concentration-time curve from time 0 to infinity. Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product ([14C]-TAK-385) .|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||nanogram hour per milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
643062|NCT02252354|Primary|Part 1: AUC(0-inf): Area Under the Plasma and Whole Blood Radioactivity Concentration-time Curve From Time 0 to Infinity for [14C]-TAK-385|AUC(0-inf) is measure of area under the curve from time 0 to infinity. Radioactivity corresponds to NMT 4.7 MBq (127 mCi). AUC(0-inf) was measured in nanogram equivalent*hour per milliliter (ng eq*hr/mL) and was calculated as disintegration per minute per mL (DPM/mL). Total [14C]-TAK-385 determination of plasma and whole blood samples was determined by AMS method.|Day 1 pre-dose and various time-points (up to 288 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||ng eq*hr/mL||Standard Deviation|Geometric Mean
643063|NCT02252354|Primary|Part 1: Cmax: Maximum Observed Plasma Concentration for TAK-385|Maximum observed concentration (Cmax) is the peak concentration of a drug after administration, obtained directly from the concentration-time curve. Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product ([14C]-TAK-385).|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
643064|NCT02252354|Primary|Part 1: Cmax: Maximum Observed Plasma and Whole Blood Radioactivity Concentration for [14C]-TAK-385|Maximum observed concentration (Cmax) is the peak concentration of a drug after administration, obtained directly from the concentration-time curve. Radioactivity corresponds to NMT 4.7 MBq (127 mCi). Cmax was measured in nanogram equivalent per milliliter (ng eq/mL) and was calculated as disintegration per minute per mL (DPM/mL). Total [14C]-TAK-385 determination of plasma and whole blood samples was determined by AMS method.|Day 1 pre-dose and various time-points (up to 288 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||ng eq/mL||Standard Deviation|Geometric Mean
643065|NCT02252354|Primary|Part 1: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-385|Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax. Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product ([14C]-TAK-385).|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||hours||Full Range|Median
643066|NCT02252354|Primary|Part 1: Time to Reach the Maximum Plasma and Whole Blood Radioactivity Concentration (Cmax) for [14C]-TAK-385|Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax. Radioactivity corresponds to no more than (NMT) 4.7 millibecquerel (MBq) (127 microcurie [mCi]). Cmax was calculated as disintegration per minute per mL (DPM/mL). Total [14C]-TAK-385 determination of plasma and whole blood samples was determined by accelerator mass spectrometry (AMS) method.|Day 1 pre-dose and various time-points (up to 288 hours) post-dose|Pharmacokinetic (PK) set included all participants in the safety set with at least one measurable plasma concentration.||hours||Full Range|Median
643067|NCT02252133|Primary|Success Rate of Lens Centration After 7 ± 2 Days of Wear|Lens centration (the centration of the contact lens over the cornea) was rated by the investigator during slit lamp examination using a 5-point scale (0=optimal, 4=severe decentration). Success was defined as the percentage of subjects whose lens centration was rated as “optimal” or “slight decentration. One eye (study eye) was analyzed.|Day 7, each product|This analysis population includes all subjects who used the study lenses and who met all inclusion criteria and did not meet any exclusion criteria.||percentage of subjects|||Number
643068|NCT02251912|Secondary|Alcohol Craving|Mean weekly Penn Alcohol Craving Scale (PACS) scores.The PACS is a five-item self-administered instrument for assessing craving, frequency, intensity, and duration of thoughts about drinking as well as the ability to resist drinking. Scores range from: Minimum: 0 Maximum: 30 Lower scores are associated with better outcomes.|12 weeks|||units on a scale||Standard Error|Least Squares Mean
643069|NCT02251912|Primary|Mean Weekly Drinks Per Drinking Day|The mean number of standard drinks (the amount of alcohol in a standard drink is roughly equivalent to the amount of alcohol in a 12 ounce beer) consumed by subjects on days when they drank alcoholic beverages each week averaged over the 12-week trial.|12 weeks|||number of drinks per drinking day||Standard Error|Least Squares Mean
643070|NCT02251912|Primary|Proportion of Heavy Drinking Days|Mean proportion of days per week, over the 12-week trial, when subjects drank heavily (5 or more standard drinks for men, 4 or more standard drinks for women).|12 weeks|||proportion of days per week||Standard Error|Least Squares Mean
643071|NCT02251886|Primary|Number of Participants With Version of Fetal Breech Position to Cephalic Position up to 4 Weeks After Treatment|Number of Participants with Version of Fetal Breech Position to Cephalic Position up to 4 weeks after treatment|4 weeks|||participants|||Number
643072|NCT02251652|Secondary|Change in Actinic Keratoses by Anatomic Site|To evaluate the number of AKs (both hypertrophic and non-hypertrophic) before therapy by anatomic site (dorsal hand) at Day 57 as compared to baseline|Baseline and Day 57|Comparisons of proportion of responders between treated and control hands||percent change|Actinic Keratoses lesions|Standard Deviation|Mean
643073|NCT02251652|Secondary|Change in Number of All Actinic Keratoses|To evaluate and compare the mean reduction in number of all AKs (hypertrophic and non-hypertrophic) on the dorsal hands of the combination cryotherapy- ingenol mebutate treated side vs. the cryotherapy alone side on Day 57 as compared to baseline|Baseline and Day 57|Comparisons of proportion of responders between treated and control hands||percent change|Actinic Keratoses lesions|Standard Deviation|Mean
643074|NCT02251652|Primary|Safety of Combination Therapy vs Cryotherapy Alone|To evaluate the safety of cryotherapy plus ingenol mebutate on dorsal hands and compare it to the safety of cryotherapy alone looking at Adverse Events.|Day 57|||Participants|||Count of Participants
643075|NCT02251613|Secondary|Mean Conjunctival Hyperemia at 20 Minutes Post-CAC, Day 1|A CAC (one drop of allergen solution to each eye) was performed 5 minutes after study medication instillation. Conjunctival hyperemia (redness) was evaluated by the investigator based on biomicroscopy for each eye at 20 (±1) minutes post-CAC and rated on a 0-4 scale (0=none, 4=extremely severe).|Day 1, 20 minutes post-CAC|This analysis population includes all randomized participants.||units on a scale|Participants|Standard Deviation|Mean
643076|NCT02251613|Primary|Mean Ocular Itching at 7 Minutes Post-CAC, Day 1|A CAC (one drop of allergen solution to each eye) was performed 5 minutes after study medication instillation. Ocular itching was assessed by the patient for each eye at 7 (±1) minutes post-CAC and rated on a 0-4 scale (0=none, 4=incapacitating itch with irresistible urge to rub).|Day 1, 7 minutes post-CAC|This analysis population includes all randomized participants.||units on a scale|Participants|Standard Deviation|Mean
643077|NCT02251561|Secondary|Proportion of Participants Scoring ≥ 2 for Corneal Staining Area With Fluorescein|The contact lens was removed, the cornea was stained with fluorescein (ophthalmic dye), and pictures of the corneal surface were taken. Corneal staining area was evaluated for each eye individually against representative pictures and scored on a 0-3 scale [0=No staining; 1=Staining with small area (1 to 25% of corneal surface); 2=Staining with medium area (26 to 50% of corneal surface); 3=Staining with large area (51% of corneal surface or greater)]. Proportion of participants is reported as a percentage.|Day 1, after 2 hours of wear|This analysis population includes all subjects who used the study products and had examination/observation data after use.||percentage of participants|||Number
643078|NCT02251561|Primary|Proportion of Participants Scoring ≥ 2 for Corneal Staining Density With Fluorescein|The contact lens was removed, the cornea was stained with fluorescein (ophthalmic dye), and pictures of the corneal surface were taken. Corneal staining density was evaluated for each eye individually against representative pictures and scored on a 0-3 scale (0=No staining; 1=Staining with low density; 2=Staining with moderate density; 3=Staining with severe density). Proportion of participants is reported as a percentage.|Day 1, after 2 hours of wear|This analysis population includes all subjects who used the study products and had examination/observation data after use.||percentage of participants|||Number
643079|NCT02250807|Secondary|Percentage of Participants With Viral Relapse|Participants were considered to have viral relapse if they did not achieve SVR12 and meet the following conditions: 1) at EOT, HCV RNA less than (<)LLOQ, undetectable, and 2) during the follow-up period, HCV RNA greater than or equal to (>=)LLOQ.|Up to follow-up week 24|ITT population included all randomized participants who received at least 1 dose of study medication (SMV and/or SOF).||percentage of participants|||Number
643080|NCT02250807|Secondary|Percentage of Participants With Viral Breakthrough|Participants with confirmed >1.0 log10 increase in HCV RNA from nadir or confirmed HCV RNA >100 IU/mL in participants who had previously achieved HCV RNA <LLOQ.|Up to follow-up Week 24|ITT population included all randomized participants who received at least 1 dose of study medication (SMV and/or SOF).||percentage of participants|||Number
643081|NCT02250807|Secondary|Percentage of Participants With On-Treatment Failure|Participants were considered on-treatment failures if they have at EOT (confirmed) detectable HCV RNA, i.e., <LLOQ detectable or >=LLOQ.|through 12 weeks (EOT)|ITT population included all randomized participants who received at least 1 dose of study medication (SMV and/or SOF).||percentage of participants|||Number
643082|NCT02250807|Secondary|Percentage of Participants With On-treatment Virologic Response of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)|Percentage of participants with HCV RNA less than (<) 15 IU/mL undetectable or detectable or detectable /undetectable at specific time points were observed.|Week 2, 3, 4, 12 and EOT|ITT population included all randomized participants who received at least 1 dose of study medication (SMV and/or SOF).||percentage of participants|||Number
643083|NCT02250807|Secondary|Percentage of Participants With Sustained Virologic Response 24 Weeks After End of Therapy (SVR24)|Participants were considered to have reached SVR24, if at the time point of SVR24 (that is [i.e.], 24 weeks after the end of treatment [EOT]) the following condition has been met: HCV RNA < lower limit of quantification (LLOQ), i.e., 15 IU/mL, detectable or undetectable.|At 24 weeks after EOT|ITT population included all randomized participants who received at least 1 dose of study medication (SMV and/or SOF).||percentage of participants||95% Confidence Interval|Number
643084|NCT02250807|Secondary|Percentage of Participants With Sustained Virologic Response 4 Weeks After End of Therapy (SVR4)|SVR4 is defined as the percentage of participants with hepatitis C virus ribonucleic acid (HCV RNA) less than (<) lower limit of quantification (LLOQ; 15 international unit per milliliter [IU/mL]) detectable or undetectable 4 weeks after actual EOT.|4 weeks after EOT|ITT population included all randomized participants who received at least 1 dose of study medication (SMV and/or SOF).||percentage of participants||95% Confidence Interval|Number
643085|NCT02250807|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After End of Treatment (EOT) (SVR12)|SVR12 is defined as the percentage of participants with hepatitis C virus ribonucleic acid (HCV RNA) less than (<) lower limit of quantification (LLOQ; 15 international unit per milliliter [IU/mL]) detectable or undetectable 12 weeks after actual EOT.|12 weeks after EOT|Intent-to-treat (ITT) population included all randomized participants who received at least 1 dose of study medication (SMV and/or SOF).||percentage of participants||95% Confidence Interval|Number
643086|NCT02250703|Secondary|Presence of Amnesia to Mask Induction|Yes or No (if the patient remembers mask induction)|Day 0: at the time of discharge of the patient from the recovery room|7 patients in the M group and 5 patients in D group had significant developmental delay and could not answer the question regarding memory of mask induction. Thus, only 61 were analyzed for this part||Participants|||Count of Participants
643721|NCT02229864|Secondary|Number of Subjects With All Myocardial Infarction (MI)|All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI).|0 to 758 Days|||Participants|||Count of Participants
643088|NCT02250703|Secondary|Acceptance of Mask Induction|"on a scale of 1 to 4
excellent( cooperative)
good( slight fear, easily calmed)
fair ( moderate fear, not calmed with reassurance)
Poor( agitated, terrified) 1 and 2 are considered satisfactory 3 and 4 are considered unsatisfactory"|Day 0: At the time when anesthesia is induced|||Participants|||Count of Participants
643089|NCT02250703|Primary|University of Michigan Sedation Scale|"Level of sedation at separation from parents and at the time of mask induction will be measured on a scale of 0 to 4 (University of Michigan Sedation Scale)
University of Michigan Sedation Scale:
0 -Awake/Alert
1 -Minimally Sedated: Tired/sleepy, appropriate response to verbal conversation and/or sounds.
2- Moderately Sedated: Somnolent/sleeping, easily aroused with light tactile stimulation.
3 - Deeply Sedated: Deep sleep, arousable only with significant physical stimulation.
4 – Unarousable
Moderately and Deeply sedated: Satisfactory Awake, minimally sedate, unarousable: Unsatisfactory"|Day 0:Just before the patient will be brought to the operating room|||Participants|||Count of Participants
643090|NCT02250274|Secondary|Ratio Between Immunoglobulin A (IgA):Immunoglobulin G (IgG)||Day 7|There were too few samples collected within each group to conduct a reasonable analysis of this outcome. The samples collected are being stored for potential future use.|||||
643091|NCT02250274|Secondary|Antibody Dependent Cellular Cytotoxicity (ADCC) Titers||Change from Baseline to 28 days||10/2017||||
643092|NCT02250274|Secondary|Polymerase Chain Reaction (PCR) Confirmed Influenza Illness||Onset >13 days after vaccination and before April 1, 2015|||participants|||Number
643093|NCT02250274|Primary|Hemagglutination Inhibition (HI) Titer Response to Vaccine and Circulating Strains of Influenza||Change from Baseline to 28 days|||Titers||95% Confidence Interval|Geometric Mean
643094|NCT02249728|Secondary|Oral PK Profile of [14C]-PBT2 as Assessed by AUC(0-last)|area under the plasma concentration vs time curve to the last timepoint|0 to 72 hours|PK Population||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
643095|NCT02249728|Secondary|Ratio of Whole Blood, Plasma [14C] PBT2 at 24 Hours|Ratio of whole blood, plasma [14C] PBT2 at 24 hours|0 to 24 hours|PK population||ratio [14C] PBT2||Geometric Coefficient of Variation|Geometric Mean
643096|NCT02249728|Secondary|Safety and Tolerability of PBT2|As assessed by the number of participants with adverse events|72 h post oral dose|Safety Population||participants|||Number
643097|NCT02249728|Secondary|Oral PK Profile of PBT2 as Assessed by AUC(0-last)|Area under the plasma concentration vs time curve from time 0h to the last time point of oral PBT2 .|72 h post oral dose|||ng*hr/ml||Geometric Coefficient of Variation|Geometric Mean
643098|NCT02249728|Secondary|IV PK Profile of [14C]-PBT2 and Total Radioactivity as Assessed by AUC(0 Last)|Area under the plasma concentration vs time curve from time 0h to the last time point of IV [14C]-PBT2 .|0 to 72 h post oral dose|PK Population||ng*hr/ml||Geometric Coefficient of Variation|Geometric Mean
643099|NCT02249728|Primary|Mass Balance|Amount excreted as a percentage of the administered dose (%Ae)|168 h (7 days) post dose|PK Population||percentage of administered dose||Standard Deviation|Geometric Mean
643100|NCT02249728|Primary|Absolute Bioavailability of PBT2 (F%)|Absolute bioavailability is the amount of drug from a formulation that reaches the systemic circulation relative to an IV dose, computed as AUC(oral)/AUC(IV), with range from 0% (no drug) to 100% (all of the administered drug).|0 to 72 hours post oral dose|PK Population||percentage of absolute bioavailability||Standard Deviation|Mean
643101|NCT02249104|Secondary|Percent Change From Baseline in Non-inflammatory Lesion Count||Baseline and 8 weeks|||Percent change||Standard Deviation|Mean
643102|NCT02249104|Secondary|Percent Change From Baseline in Inflammatory Lesion Count||Baseline and 8 weeks|||Percent change||Standard Deviation|Mean
643103|NCT02249104|Secondary|Mean Change From Baseline in Non-inflammatory Lesion Count||Baseline and 8 weeks|||Lesions counted||Standard Deviation|Mean
643104|NCT02249104|Secondary|Mean Change From Baseline in Inflammatory Lesion Count||Baseline and 8 weeks|||Lesions counted||Standard Deviation|Mean
643105|NCT02249104|Secondary|Percent Change From Baseline in Total Lesion Count||Baseline and 8 weeks|||Percent change||Standard Deviation|Mean
643106|NCT02249104|Primary|Mean Change From Baseline in Total Lesion Count||Baseline and 8 weeks|||Lesions counted||Standard Deviation|Mean
643107|NCT02249052|Other Pre-specified|Change in Visible Surface Area|"Visible surface area is defined as the longest dimension (length) times the longest dimension perpendicular to length (width). Visible surface area will be analyzed as the percent change from baseline."|3 month post injection|All 19 subjects enrolled with 2 lipomas. All received AA4500 in one lipoma and placebo in the other lipoma.||percentage change from baseline||Standard Deviation|Mean
643108|NCT02249052|Other Pre-specified|Change in Visible Surface Area|"Visible surface area is defined as the longest dimension (length) times the longest dimension perpendicular to length (width). Visible surface area will be analyzed as the percent change from baseline."|1 Month post injection|All 19 subjects enrolled with 2 lipomas. All received AA4500 in one lipoma and placebo in the other lipoma.||percentage change from baseline||Standard Deviation|Mean
643109|NCT02249052|Secondary|Subject Satisfaction|Subjects very satisfied or somewhat satisfied with study treatment based upon Subject Questionnaire|6 months|1 participant did not complete the questionnaire at the final visit; therefore the analysis population was based upon 18 participants||participants satisfied|||Number
643110|NCT02249052|Secondary|Percent Change From Baseline in Greatest Dimension (Length) of Lipoma at 6 Months|Change from baseline in lipoma length Calculated as the percent change from baseline for length of the lipoma treated with AA4500 and the lipoma treated with placebo.|Baseline and 6 months|All study participants||Percent change from baseline||Standard Deviation|Mean
643111|NCT02249052|Secondary|Responder Analysis|The number of participants with at least 50% decrease in visible lipoma surface area of lipoma relative to baseline|Baseline and 6 months|All 19 participants||participants|||Number
643112|NCT02249052|Primary|Percent Change From Baseline in Surface Area of the Lipoma at Six Months|"The primary efficacy outcome is lipoma visible surface area defined as the longest dimension (length) times the longest dimension perpendicular to length (width). Visible surface area will be analyzed as the percent change from baseline at the 6-month visit."|Baseline and 6 months post injection|All 19 subjects enrolled with 2 lipomas. All received AA4500 in one lipoma and placebo in the other lipoma.||percentage change from baseline||Standard Deviation|Mean
644904|NCT02196714|Secondary|Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose|Change in Mean Chemistry Parameters (±SD) from Pre-dose to 12 Hours Post-dose|12 hours|Safety Population||g/L||Standard Deviation|Mean
643113|NCT02248818|Other Pre-specified|EEG Parameter (DAY 12) - Gamma - Change From Baseline in Total Area of the Brain (Eyes Closed) - Consistent Change in Either Direction|EEG parameter (DAY 12) - Gamma - Change from baseline in Total Area of the Brain (eyes closed) Cohort 5 & 7 , Cohort 6 did not reach Day 12; to identify a dose related change in EEG gamma bands to assess target engagement, a consistent change in either direction compared to placebo would be of interest|8 hours after dose|Safety population||uV2||Standard Deviation|Mean
643114|NCT02248818|Other Pre-specified|EEG Parameter (DAY 6) - Gamma - Change From Baseline in Total Area of the Brain (Eyes Closed)- Consistent Change in Either Direction|EEG parameter (DAY 6) - Gamma - Change from baseline in Total Area of the Brain (eyes closed) Cohort 5 & 7, Cohort 6 did not reach Day 6; to identify a dose related change in EEG gamma bands to assess target engagement, a consistent change in either direction compared to placebo was of interest|8 hours after dose|Safety population||uV2||Standard Deviation|Mean
643115|NCT02248818|Other Pre-specified|EEG Parameter (DAY 1) - Gamma - Change From Baseline in Total Area of the Brain (Eyes Closed)- Consistent Change in Either Direction|EEG parameter (DAY 1) - Gamma - Change from baseline in Total Area of the Brain (eyes closed) - to identify a dose related change in EEG gamma bands to assess target engagement, a consistent change in either direction relative to placebo would be of interest|8 hours after dose|Safety population||uV2||Standard Deviation|Mean
643116|NCT02248818|Secondary|Pharmacokinetic: Accumulation Index for Area Under Concentration Curve (0 to 24 Hour) MAD|Pharmacokinetic: Accumulation index for Area Under Concentration Curve (0 to 24 hour) MAD Cohorts 5 & 7, cohort 6 did not reach day 12 [accumulation index (Day 6 or 12 /Day1)]|Day 12 compared to Day 1|Pharmacokinetic population, MAD Cohorts 5 & 7||ratio||Standard Deviation|Mean
643117|NCT02248818|Secondary|Pharmacokinetic: Time to Maximum Plasma Concentration of AZD6765 After Day 12 (MAD) Dose of AZD8108|Pharmacokinetic: Time to Maximum plasma concentration of AZD6765 after Day 12 (MAD) dose AZD8108 Cohorts 5 & 7, Cohort 6 did not reach day 12|Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16,24,48,72 hours after Day 12 dose|Pharmacokinetic population (subjects dosed with AZD8108)||hours||Full Range|Median
643118|NCT02248818|Secondary|Pharmacokinetic: Fraction of Equivalent Dose of AZD6765 Excreted in Urine (MAD) After Day 12 Dose of AZD8108|Pharmacokinetic: Fraction of equivalent dose of AZD6765 excreted in urine (MAD) after Day 12 dose of AZD8108 Cohorts 5 & 7, Cohort 6 did not reach day 12|Collection 0-6, 0-12, 12-24, 24-48, 48-72 hr after Day 12 dose|Pharmacokinetic Population (Cohorts 1-3) AZD8108 dosed||Percent||Geometric Coefficient of Variation|Geometric Mean
643119|NCT02248818|Secondary|Pharmacokinetic: Fraction of Equivalent Dose of AZD6765 Excreted in Urine (SAD) After Single Dose of AZD8108|Pharmacokinetic: Fraction of equivalent dose of AZD6765 excreted in urine (SAD) after single dose of AZD8108 (Cohorts 1 - 3)|Collection 0-6, 6-12,12-24, 24-48, (48-72 SAD only) hy after Day 1 dose|Pharmacokinetic Population (Cohorts 1-3) AZD8108 dosed||Percent|Participants with urine volume data|Geometric Coefficient of Variation|Geometric Mean
643120|NCT02248818|Secondary|Pharmacokinetic: Time to Maximum Plasma Concentration of AZD6765 After Single (SAD)/ 1st (MAD) Dose of AZD8108|Pharmacokinetic: Time to Maximum plasma concentration of AZD6765 after single (SAD) / first (MAD) dose AZD8108|Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16,24,48,(72 SAD only) hr after day 1 dose|Pharmacokinetic population (subjects dosed with AZD8108)||hours||Full Range|Median
643121|NCT02248818|Primary|Pharmacokinetic : Maximum Concentration of AZD6765 After MAD Day 12 Dose of AZD8108|Pharmacokinetic : Maximum concentration of AZD6765 after MAD Day 12 dose of AZD8108, Cohorts 5 & 7, Cohort 6 did not reach Day 12|Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16,24,48,72 hr after Day 12 dose|Pharmacokinetic Population (those dosed with AZD8108) MAD cohorts 5 & 7||ng/mL||Geometric Coefficient of Variation|Geometric Mean
643122|NCT02248818|Primary|Pharmacokinetic : Maximum Concentration of AZD6765 After MAD Day 6 Dose of AZD8108|Pharmacokinetic : Maximum concentration of AZD6765 after MAD Day 6 dose of AZD8108, Cohorts 5 & 7, Cohort 6 did not reach Day 6|Pre-dose, 5,15.30 min, 1,1.5,2,3,4,6,8,10,12,16,24 hr after Day 6 dose|Pharmacokinetic Population (those dosed with AZD8108) MAD cohorts 5 & 7||ng/mL||Geometric Coefficient of Variation|Geometric Mean
643123|NCT02248818|Primary|Pharmacokinetic : Maximum Concentration of AZD6765 After Single/1st Dose of AZD8108|Pharmacokinetic : Maximum concentration of AZD6765 after single/first dose of AZD8108|Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16,25,48,972 SAD only)hr after Day 1 dose|Pharmacokinetic Population (those dosed with AZD8108)||ng/mL||Geometric Coefficient of Variation|Geometric Mean
643124|NCT02248818|Primary|Pharmacokinetic :Area Under the Concentration Curve (0 to 24 Hours), AZD6765 After DAY 12 Dose of AZD8108|Pharmacokinetic : Area under the concentration curve (0 to 24 hours), AZD6765 after Day 12 dose of AZD8108 cohort 5 & 7, Cohort 6 dod not reach Day 12|Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16, and 24 hours after dose|Pharmacokinetic Population (those dosed with AZD8108)||hours*ng/mL||Geometric Coefficient of Variation|Geometric Mean
643125|NCT02248818|Primary|Pharmacokinetic :Area Under the Concentration Curve (0 to Infinity), AZD6765 MAD Day 12 Dose of AZD8108|Pharmacokinetic : Area under the concentration curve (0 to infinity), AZD6765 MAD Day 12 dose of AZD8108 Cohort 5 & 7, Cohort 6 did not reach Day 12|Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16,24,48, 72 hr after Day 12 dose|Pharmacokinetic Population (those dosed with AZD8108)||hours*ng/mL||Geometric Coefficient of Variation|Geometric Mean
643126|NCT02248818|Primary|Pharmacokinetic :Area Under the Concentration Curve (0 to 24 Hour), AZD6765 MAD Day 6 Dose of AZD8108|Pharmacokinetic : Area under the concentration curve (0 to 24 hour), AZD6765 MAD Day 6 dose of AZD8108 Cohort 5 & 7, Cohort 6 did not reach Day 6|Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16,24 hr after Day 6 dose|Pharmacokinetic Population (those dosed with AZD8108)||hours*ng/mL||Geometric Coefficient of Variation|Geometric Mean
643127|NCT02248818|Primary|Pharmacokinetic :Area Under the Concentration Curve (0 to Infinity), AZD6765 After Single/1st Dose of AZD8108|Pharmacokinetic : Area under the concentration curve (0 to infinity), AZD6765 after single/first dose of AZD8108|Pre-dose,5,15,30 min, 1,1.5,2,3,4,6,8,10,12,14,16,24,48,(72 SAD only) hr after day 1 dose|Pharmacokinetic Population (those dosed with AZD8108)||hours*ng/mL||Geometric Coefficient of Variation|Geometric Mean
643128|NCT02248818|Primary|Safety Laboratory - Thyroid Stimulating Hormone Above Upper Limit of Normal|Safety Laboratory - Thyroid Stimulating Hormone participants with laboratory value above the upper limit of normal|Day -1 to 7 days after last dose|Safety population||Participants|||Number
643722|NCT02229864|Secondary|Number of Subjects With All Myocardial Infarction (MI)|All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI).|0 to 393 Days|||Participants|||Count of Participants
643129|NCT02248766|Primary|Subjective Assessments- Enfilcon A and Somofilcon A|Subjective assessments for: comfort, dryness, handling, overall lens fit, and overall vision satisfaction. Enfilcon A was assessed at baseline and somofilcon A lenses assessed at 1 week, 2 week, 4 week. Scale(s): comfort (0=very poor; 10=excellent), dryness (0=very dry; 10=no dryness), handling (0=very difficult; 10=very easy), overall lens fit (0=very unstable; 10=very stable), overall vision satisfaction (0=very unsatisfied; 10=very satisfied)|Baseline, 1 week, 2 week, 4 week|||units on a scale||Standard Deviation|Mean
643130|NCT02248766|Primary|Visual Acuity - Enfilcon A and Somofilcon A|Monocular and binocular logMAR visual acuity for enfilcon A / somofilcon A assessed at baseline and somofilcon A lenses assessed at 1 week, 2 week, 4 week.|Baseline, 1 week, 2 week, 4 week|||logMar||Standard Deviation|Mean
643131|NCT02248727|Primary|Subjective Assessments. - Enfilcon A and Somofilcon A|Subjective assessments for: comfort, dryness, handling, overall vision satisfaction, and eye whiteness. Enfilcon A was assessed at baseline and somofilcon A lenses assessed at 1 week, 2 week, 4 week. Scale(s): comfort (0=very poor; 10=excellent), dryness (0=very dry; 10=no dryness), handling (0=very difficult; 10=very easy), overall vision satisfaction (0=very unsatisfied; 10=very satisfied), habitual eye whiteness (0=not white; 10= totally white)|Baseline, 1 Week, 2 Week, 4 Week|||units on a scale||Standard Deviation|Mean
643132|NCT02248727|Primary|Visual Acuity - Enfilcon A and Somofilcon A|Monocular and binocular logMAR visual acuity for enfilcon A / somofilcon A assessed at baseline and somofilcon A lenses assessed at 1 week, 2 week, 4 week.|Baseline, 1 Week, 2 Week, 4 Week|||logMar||Standard Deviation|Mean
643133|NCT02248675|Secondary|Insomnia Severity Index (ISI)|A well-validated 7-item self-report measure developed to assess insomnia severity; higher scores are associated with greater severity (range of 0-28 with higher scores indicating greater insomnia severity).|post-treatment (~6-8 weeks)|||units on a scale||Standard Deviation|Mean
643134|NCT02248675|Secondary|Patient Health Questionnaire-9 (PHQ-9)|A well-validated 9-item self-report measure developed to assess depression severity; higher scores are associated with greater severity (range of 0-27 with higher scores indicating more severe depression severity).|post-treatment (~6-8 weeks)|||units on a scale||Standard Deviation|Mean
643135|NCT02248675|Secondary|Perceived Treatment Beliefs (PTS)|A 21-item measure (with items ranging from 1-7) based on the theory of planned behavior and designed to assess beliefs about treatment and plans to engage in treatment in military populations. This measure will focus on engagement in PTSD and depression treatments. The total score has a range of 21-147 with higher scores indicating higher likelihood of engaging in care.|post-treatment (~6-8 weeks)|||units on a scale||Standard Deviation|Mean
643136|NCT02248675|Primary|Columbia Suicide Severity Rating Scale (C-SSRS)|The entire Columbia Suicide Severity Rating Scale (C-SSRS) will be administered, but the investigators will use its' Suicidal Ideation Intensity scale (0-25 score range summed from five items, with higher scores indicating more severe suicidal ideation) as the primary outcome.|post-treatment (~6-8 weeks)|||units on a scale||Standard Deviation|Mean
643137|NCT02248558|Secondary|Cost-effectiveness of Developing HIV Testing Promotional Videos|Cost-effectiveness of developing the crowdsourced video compared to the conventional video|Up to one year|||USD|||Number
643138|NCT02248558|Secondary|Likelihood of HIV Testing|"All individuals will be asked how likely they are to test for HIV soon immediately before and after watching the videos (during enrollment). Likelihood of HIV testing will be measured on a 4-point numerical Likert scale rating scale. 0 will be very unlikely, 1 will be unlikely, 2 will be likely, and 3 will be very likely. The percentage of individuals who report increased likelihood of HIV testing will be reported."|Up to one day|||Participants|||Count of Participants
643139|NCT02248558|Primary|First-Time HIV Testing|All individuals enrolled in the study will receive a cell phone text message three weeks later asking if they have received an HIV test. Among those individuals who do not respond to the text message, another text will be sent at four weeks after the video. We anticipate the median duration of follow-up to be approximately 3.5 weeks following the video intervention.|Up to 4 weeks following the video intervention|||Participants|||Count of Participants
643140|NCT02248480|Secondary|Change From Baseline on the WOMAC Questionnaire Physical Function Subscale|The WOMAC osteoarthritis scale consists of 24 items in 3 subscales: pain, stiffness, and physical function. The physical function subscale rates participant pain during stair use, rising from sitting, standing, bending, walking, getting in/out of a car, shopping, putting on/taking off socks, rising from bed, lying in bed, getting in/out of the bath, sitting, getting on/off the toilet, heavy household duties, and light household duties. Each question was answered using a 5-point Likert scale (0 to 4). Physical Function Subscale has a range of scores of 0 (none) to 68 (extreme). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, baseline data as covariates.|Baseline, 14 Weeks|All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
643141|NCT02248480|Secondary|Change From Baseline on the WOMAC Questionnaire Stiffness Subscale|The WOMAC index (pain, stiffness, physical function subscales) will be completed by the participant.The stiffness subscale had 2 questions on stiffness associated with time of day (morning versus later in the day). Each question was answered using a 5-point Likert scale (0 to 4). The stiffness subscale has a range of scores of 0 (none) to 8 (extreme). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, baseline data as covariates.|Baseline, 14 Weeks|All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
643142|NCT02248480|Secondary|Change From Baseline on the WOMAC Questionnaire Pain Subscale|The WOMAC index (pain, stiffness, physical function subscales) was completed by the participant.The pain subscale had 5 questions on pain associated with every day tasks. Each question was answered using a 5-point Likert scale (0 to 4). The pain subscale has a range of scores of 0 (none) to 20 (extreme). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, baseline data as covariates.|Baseline, 14 Weeks|All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
643143|NCT02248480|Secondary|Percentage of Participants With a Responder Rate Based on OMERACT-OARSI Criteria|A responder is required to meet at least one condition: reduction of ≥50% and ≥2 score in Weekly Mean of the 24-Hour Average Pain Score, reduction of ≥50% or ≥13.6 score in WOMAC (difficulty in dairy activity) and meet ≥2 out of following 3 conditions: reduction of ≥20% and ≥1 score in Weekly Mean of the 24-Hour Average Pain, reduction of ≥20% and ≥6.8 score in WOMAC (difficulty in dairy activity), PGAI score ≥2.|Baseline, Week 14|All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment. The last observation carried forward (LOCF) was used.||percentage of participants|||Number
643144|NCT02248480|Secondary|Percentage of Participants With Reduction of ≥30% and ≥50% in BPI Average Pain Score|Brief Pain Inventory Severity: Average Pain Score: A self-reported scale that measures the severity of pain based on the average pain experienced during the past 24-hours. The severity scores ranged from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline, Week 14|All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment. The last observation carried forward (LOCF) was used.||percentage of participants|||Number
643145|NCT02248480|Secondary|Change From Baseline on Weekly Mean of the 24-Hour Average Pain and Worst Pain Score|24-hour average pain severity scores were recorded daily on an 11-point Likert scale, an ordinal scale, with scores ranging from 0 (no pain) to 10 (worst possible pain). The 11-point Likert scale was also used for assessment of average pain and worst pain within 24-hours. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, and baseline data as covariates.|Baseline, Week 14|All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
643146|NCT02248480|Secondary|Percentage of Participants With a 30% and 50% Reduction in Average Pain Score on Weekly Mean of the 24-Hour Average Pain Score on the 11-Point Numeric Rating Scale|24-hour average pain severity scores were recorded daily on an 11-point Likert scale, an ordinal scale, with scores ranging from 0 (no pain) to 10 (worst possible pain). The 11-point Likert scale was also used for assessment of average pain within 24-hours.|Baseline,Week 14|All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment. The last observation carried forward (LOCF) was used.||percentage of participants|||Number
643147|NCT02248480|Secondary|Change in Baseline in Brief Pain Inventory Severity and Interference Scores (BPI-S, BPI-I) Change From Baseline in BPI Pain Severity Items and Interference Items Score|BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, and baseline data as covariates.|Baseline, Week 14|All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
643148|NCT02248480|Secondary|Change From Baseline on the 5 Dimension (EQ-5D) Version of the European Quality of Life Instrument|The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument and was completed on five dimensions (mobility, self care, usual activities, pain/discomfort and anxiety/depression) to measure health-related quality of life on a scale from 0-1, with the higher score indicating a better health state perceived by the participant. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a three level scale (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the Japan population-based algorithm. Least squares (LS) mean was calculated using an ANCOVA approach including administration groups as fixed effects, and baseline data as covariate.|Baseline, Week 14|All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment. The last observation carried forward (LOCF) was used.||units on a scale||Standard Error|Least Squares Mean
643149|NCT02248480|Secondary|Change From Baseline on the Patient Global Assessment Illness (PGAI) Score||Baseline, Week 14|Zero participants analyzed. PGAI outcome measure was registered incorrectly thus no analysis produced.|||||
643150|NCT02248480|Secondary|Change From Baseline on the Western Ontario and McMaster Osteoarthritis Index (WOMAC) Questionnaire Total Score|The 24-question WOMAC Osteoarthritis Index assesses osteoarthritis symptoms using pain (5 questions), stiffness (2 questions) and physical function (17 questions) subscales. The WOMAC Osteoarthritis Index version 3.1 was administered according to the study schedule. The WOMAC total score was calculated for each participant at each time point for analysis as the mean total score, range 0 (none) -96 (extreme). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, and baseline data as covariates.|Baseline, Week 14|All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
643151|NCT02248480|Secondary|Percentage of Participants With Fall Events From Fall Questionnaire|Participants evaluated their experience with and details of falls which were recorded.|Baseline through Week 14|All randomized participants who received at least 1 dose of study drug.||percentage of participants|||Number
643165|NCT02247765|Primary|SpO2 Accuracy During Motion Conditions - MaxN Sensor|For each range specified, SpO2 accuracy of the pulse oximeter equipment is stated in terms of the Accuracy Root‐Mean‐Square (ARMS) difference between measured values (SpO2) and reference blood values (SaO2). The MaxN sensor has a different bandage from the MaxA sensor, and therefore a different form and fit.|up to 6 months|||Accuracy Root Mean Square|||Number
643723|NCT02229864|Secondary|Number of Subjects With All Myocardial Infarction (MI)|All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI).|0 to 208 Days|||Participants|||Count of Participants
643152|NCT02248480|Secondary|Change From Baseline on the Beck Depression Inventory (BDI-II) Total Score|Beck Depression Inventory-II: BDI-II is a 21-item, participant-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to symptoms of depression were scored on a 4-point scale ranging from 0 to 3 and was summed to give a single score. A total score of 0-13 was considered minimal range, 14-19 was mild, 20-28 was moderate, and 29-63 was severe. Least squares (LS) mean was calculated using a ANCOVA approach’ including administration groups as fixed effects, and baseline data as covariate.|Baseline, Week 14|All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment. The last observation carried forward (LOCF) was used.||units on a scale||Standard Error|Least Squares Mean
643153|NCT02248480|Secondary|Change From Baseline on the 36-Item Short-Form Health Survey (SF-36)|36-item Short-Form Health Survey: SF-36 Health Status Survey is a generic, health-related scale assessing participant’s quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health. Domain scores: general health (range: 5-25); physical functioning (range: 10-30); role-physical (range: 4-8); role-emotional (range: 3-15); social functioning (range: 2-10); bodily pain (range: 2-12); vitality (range: 4-20); mental health (range: 5-25). Each raw scale score was converted to a scale score ranging from 0-100 points, , with higher values representing a better outcome [(Raw score) − min{raw score}] / (max {raw score} − min{raw score}) x 100]. Least squares (LS) mean was calculated using Analysis of covariance (ANCOVA) approach including administration groups as fixed effects, and baseline data as covariate.|Baseline, Week 14|All participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment. The last observation carried forward (LOCF) was used.||units on a scale||Standard Error|Least Squares Mean
643154|NCT02248480|Secondary|Change From Baseline on the Clinical Global Impression of Severity (CGI-S)|CSI-S measures severity of illness at the time of assessment compared with start of treatment with scores ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, and baseline data as covariates.|Baseline, Week 14|All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
643155|NCT02248480|Secondary|Change From Baseline in Patient Global Impression of Improvement (PGI-Improvement)|Patient’s Global Impressions of Improvement Scale: PGI-I measures a participant's perception of improvement at the time of assessment compared with the start of treatment. Score ranges from 1 (very much better) to 7 (very much worse). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, and PGI-severity at baseline as covariates.|Baseline, 14 Weeks|All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
643156|NCT02248480|Primary|Change From Baseline on the Brief Pain Inventory (BPI) 24-Hour Average Pain Score|Brief Pain Inventory Severity: Average Pain Score: A self-reported scale that measures the severity of pain based on the average pain experienced during the past 24-hours. The severity scores ranged from 0 (no pain) to 10 (pain as severe as you can imagine). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, and BPI average pain severity at baseline as covariates.|Baseline, Week 14|All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
643157|NCT02248246|Secondary|Percentage of Participants With Hemostasis at the IMV|Hemostasis of the IMV is a dichotomous variable (i.e. yes or no). “Yes” is defined as a single activation of the Advanced Hemostasis Mode to transect and seal the IMV.|Intraoperatively|Safety Set - all subjects in whom the procedure was started.||percentage of participants||95% Confidence Interval|Number
643158|NCT02248246|Primary|Percentage of Participants With Hemostasis at the IMA|Hemostasis of the IMA is a dichotomous variable (i.e. yes or no). “Yes” is defined as a single activation of the Advanced Hemostasis Mode to transect and seal the IMA.|Intraoperatively|Safety Set - all subjects in whom the procedure was started.||percentage of subjects||95% Confidence Interval|Number
643159|NCT02248103|Secondary|Bone Defect Area|linear measurements collected from a digital radiography program to estimate percentage of defect fill.|Baseline and 6 months|||"mm^2"||Standard Deviation|Mean
643160|NCT02248103|Secondary|Pocket Depth|Estimation of pocket depth in chronic periodontitis patients at baseline and 6 months after guided tissue regeneration|Baseline and 6 months|||mm||Standard Deviation|Mean
643161|NCT02248103|Primary|Clinical Attachment Level|Estimation of clinical attachment level in chronic periodontitis patients at baseline and 6 months after guided tissue regeneration|Baseline and 6 months|defects||mm||Standard Deviation|Mean
643162|NCT02247960|Secondary|Number of Participants With Bacteria in Urine|Bacterial cultures were performed on urine and the presence of the following bacteria was determined: Acinetobacter, Coagulase-negative staphylococci, Diptherioids, Escherichia coli, Enterobacter, Enterococcus, Klebsiella pneumonia, and Lactoferrin. Participants who were positive for one or more of these were considered positive.|3 months|10 participants in the Ciprofloxacin arm and 16 participants in the no antibiotic arm did not have samples collected for testing.||Participants|||Count of Participants
643163|NCT02247960|Secondary|Number of Participants Positive for Clostridium Difficile|Development of Clostridium difficile was measured in stool for clostridium difficile infection by enzyme immunoassay (EIA) and/or polymerase chain reaction (PCR).|3 months|this outcome measure was only collected on patients who had their catheter removed (ie. started period 2)||Participants|||Count of Participants
643164|NCT02247960|Primary|Number of Participants With a Positive Urinary Tract Infection|After removal of the catheter, urine was tested for infection whenever symptoms were experienced by the participants from the time they enrolled to 12 months following their operation.|12 months|this outcome measure was only collected on patients who had their catheter removed (ie. started period 2)||Participants|||Count of Participants
648274|NCT02107014|Primary|Change in IL-13 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].|||pg/mL||95% Confidence Interval|Median
643166|NCT02247765|Primary|SpO2 Accuracy During Motion Conditions - MaxA Sensor|For each range specified, SpO2 accuracy of the pulse oximeter equipment is stated in terms of the Accuracy Root‐Mean‐Square (ARMS) difference between measured values (SpO2) and reference blood values (SaO2). The MaxA sensors has a different bandage from the MaxN sensor, and therefore a different form and fit.|up to 6 months|||Accuracy Root Mean Square|||Number
643167|NCT02247401|Secondary|Percentage of Participants With Post-treatment Relapse Within 12 Weeks Following End of Treatment in Each Arm|Post-treatment relapse was defined as defined as confirmed HCV RNA > LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA < LLOQ at the end of treatment.|Up to 12 weeks after first dose|Intent-to-treat population: all participants who received at least 1 dose of study drug.||percentage of participants||95% Confidence Interval|Number
643168|NCT02247401|Secondary|Percentage of Participants With On-treatment Virologic Failure in Each Treatment Arm|On-treatment virologic failure was defined as quantifiable HCV RNA throughout the entire treatment period with at least 6 weeks of treatment, confirmed HCV RNA greater than the LLOQ after previously having unquantifiable HCV RNA, or a confirmed increase from nadir of at least one log10 in HCV RNA during treatment.|Up to 12 or 24 weeks after first dose|Intent-to-treat population: all participants who received at least 1 dose of study drug.||percentage of participants||95% Confidence Interval|Number
643169|NCT02247401|Primary|Number of Participants With Adverse Events|An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.|Screening until 30 days after last dose|Safety Population: all participants who received at least 1 dose of study drug.||Participants|||Count of Participants
643170|NCT02247401|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Each Treatment Arm|SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (< LLOQ) 12 weeks after the last dose of study drug.|12 weeks after last dose|Intent-to-treat population: all participants who received at least 1 dose of study drug.||percentage of participants||95% Confidence Interval|Number
643171|NCT02247011|Primary|Serum Creatinine|Fasting blood sample was collected for each subject.The level of serum creatinine(Cr) was analyzed.|5 years|||umol/l||Standard Error|Mean
643172|NCT02247011|Primary|Serum Alkaline Phosphatase|Fasting blood sample was collected for each subject. The level of serum alkaline phosphatase (ALP) was analyzed.|5 years|||U/L||Standard Deviation|Mean
643173|NCT02247011|Primary|Biochemical Markers|Fasting blood sample was collected for each subject. Common biochemical markers including serum calcium(Ca), serum phosphate(P), serum glucose(Glu), serum creatinine(Cr), alkaline phosphatase(ALP)were analyzed.|5 year|||mmol/L||Standard Deviation|Mean
643174|NCT02247011|Primary|Bone Turnover Markers and 25(OH)D|C-terminal telopeptide of type I collagen (β-CTX), N-aminoterminal prepeptide of type I procollagen (P1NP), and 25-hydroxyvitamin D (25[OH]D) will be determined by a laboratory method of electrochemiluminescence (E170; Roche Diagnostics, Basel, Switzerland) in the institute (Peking Union)|5 year|||ng/ml||Inter-Quartile Range|Median
643175|NCT02247011|Primary|Bone Mineral Density|bone mineral density of Lumbar spine and femoral neck were measured by dual-energy X-ray absorptiometry (DXA) (Lunar or Norland)|5 year|||g/cm^2||Inter-Quartile Range|Median
643176|NCT02247011|Primary|Vertebral Fracture Incidence|Vertebral fractures were assessed by lateral radiograph. The overall incidence of vertebral fracture of the subjects is 5.23%( 51/975)|5 year|||participants|||Number
643177|NCT02247011|Primary|Non-vertebral Fracture Incidence|Non-vertebral fractures were assessed by questionnaire survey.The overall incidence of non-vertebral fracture of the subjects is 7.18%( 70/975).|5 year|In 1100 participants, 975 of them finished the questionnaire||participants|||Number
643178|NCT02246673|Secondary|Incidence of Treatment-Emergent Adverse Events||10 weeks|||Number of participants|||Number
643179|NCT02246673|Secondary|Apparent Terminal Half-life (t1/2)|t1/2 of multiple-dose RDEA3170 administered in combination with febuxostat from plasma|Days 7 to 28|||hr||95% Confidence Interval|Geometric Mean
643180|NCT02246673|Secondary|Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)|AUC last of multiple-dose RDEA3170 administered in combination with febuxostat from plasma|Days 7 to 28|||ng·hr/mL||95% Confidence Interval|Geometric Mean
643181|NCT02246673|Secondary|Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24)|AUC 0-24 of multiple-dose RDEA3170 administered in combination with febuxostat from plasma|Days 7 to 28|||ng·hr/mL||95% Confidence Interval|Geometric Mean
643182|NCT02246673|Secondary|Time of Occurrence of Maximum Observed Concentration (Tmax)|Tmax of multiple-dose RDEA3170 administered in combination with febuxostat from plasma|Days 7 to 28|||hr||Full Range|Median
643183|NCT02246673|Secondary|Maximum Observed Plasma Concentration (Cmax)|Cmax of multiple-dose RDEA3170 administered in combination with febuxostat from plasma|Days 7 to 28|||ng/mL||95% Confidence Interval|Geometric Mean
643184|NCT02246673|Primary|Fract. Excretion of Uric Acid % Change (0-24h) (FEUA, CB)|Percentage (%) change from baseline in fractional excretion of uric acid.|28 days|||Percentage (%)||Standard Error|Mean
643185|NCT02246673|Primary|Renal Clearance of Uric Acid % Change (0-24h) (CLur, CB)|Percentage (%) change from baseline in renal clearance of uric acid.|28 days|||Percentage (%)||Standard Error|Mean
643186|NCT02246673|Primary|Urine Uric Acid % Change (0-24h) (Aeur, CB)|Percentage (%) change from baseline in the amount of uric acid recovered in urine.|28 days|||Percentage (%)||Standard Error|Mean
643187|NCT02246673|Primary|Serum Urate Maximum Percentage (%) Change (Emax, CB)|Maximum observed percentage (%) change from baseline in serum urate concentrations.|28 days|||Percentage (%)||Standard Error|Mean
643188|NCT02246582|Secondary|Retrospective Analysis (MARD for the GSR With Minimum and 1 Additional Calibration)|Retrospective analysis using one GSR: minimum and 3-4 calibrations will be evaluated. Enlite 3 Sensor values will be compared to YSI plasma glucose values during YSI frequent sample testing. Enlite 3 Sensor values will be compared to YSI plasma glucose values, which is considered as the gold standard, during the frequent sample testing days (Days 1, 3 and 7). MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100). Note that results from multiple testing days will be pooled together for reporting purpose.|7 Days|Even though participants were randomized to two groups, data was collected as a whole and there was no intention to analyze the two groups seperately.||percentage||Standard Deviation|Mean
643189|NCT02246582|Secondary|Retrospective Re-Analysis (MARD With 1 Additional Calibration)|Retrospective re-analysis to simulate 640G Pump and Guardian Mobile 1-minute raw data collected by GST3C Transmitters and GST4C Transmitter: Enlite 3 Sensor accuracy with 3-4 calibrations throughout the day (derived from re-analysis of Enlite 3 Sensor data using actual fingerstick values). Enlite 3 Sensor values will be compared to YSI plasma glucose values, which is considered as the gold standard, during the frequent sample testing days (Days 1, 3 and 7). MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100). Note that results from multiple testing days will be pooled together for reporting purpose.|7 Days|Even though participants were randomized to two groups, data was collected as a whole and there was no intention to analyze the two groups seperately.||percentage||Standard Deviation|Mean
643190|NCT02246582|Primary|Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD)|Enlite 3 Sensor accuracy using two real time devices: 1) 640G Pump and 2) Guardian Mobile with the minimum calibration requirements (every 12 hours after the second calibration) will be evaluated. Enlite 3 Sensor values will be compared to YSI plasma glucose values, which is considered as the gold standard, during the frequent sample testing days (Days 1, 3 and 7). MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100). Note that results from multiple testing days will be pooled together for reporting purpose.|7 Days|Even though participants were randomized to two groups, data was collected as a whole and there was no intention to analyze the two groups seperately.||percentage||Standard Deviation|Mean
643191|NCT02246166|Secondary|Body Temperature Reduction|Summary statistics for body temperature was presented at baseline and at 15, 30, 60, 120,180 and 240 minutes post treatment. Wilcoxon Rank Sum test was used to investigate if there are any significant treatment differences.|Change from baseline in 15, 30, 60,120, 180, and 240 minutes|The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.||°C (degree Celsius)||Standard Error|Least Squares Mean
643192|NCT02246166|Secondary|Cough Severity Assessment|Participants self-assessed cough severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All cough severity assessment values were recorded in a questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.|Change from baseline in 15, 30, 60,120, 180, and 240 minutes|The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.||Score on scale||Standard Error|Least Squares Mean
643193|NCT02246166|Secondary|Sneezing Severity Assessment|Participants self-assessed sneezing severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All sneezing severity assessment values were recorded in a questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.|Change from baseline in 15, 30, 60,120, 180, and 240 minutes|The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.||Score on scale||Standard Error|Least Squares Mean
643194|NCT02246166|Secondary|Runny Nose Severity Assessment|Participants self-assessed runny nose severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All runny nose severity assessment values were recorded in questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.|Change from baseline in 15, 30, 60,120, 180, and 240 minutes|The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.||Score on scale||Standard Error|Least Squares Mean
643195|NCT02246166|Secondary|Nasal Congestion Severity Assessment|Participants self-assessed nasal congestion severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All nasal congestion severity assessment values were recorded in a questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.|Change from baseline in 15, 30, 60,120, 180, and 240 minutes|The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.||Score on scale||Standard Error|Least Squares Mean
643196|NCT02246166|Secondary|Extremities Pain Severity Assessment|Participants self-assessed extremities pain severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All extremities pain severity assessment values were recorded in a questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.|Change from baseline in 15, 30, 60,120, 180, and 240 minutes|The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.||Score on scale||Standard Error|Least Squares Mean
643197|NCT02246166|Secondary|Headache Severity Assessment|Participants self-assessed headache severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All headache severity assessment values were recorded in questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.|Change from baseline in 15, 30, 60,120, 180, and 240 minutes|The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.||Score on scale||Standard Error|Least Squares Mean
643198|NCT02246166|Secondary|Sore Throat Severity Assessment|Participants self-assessed sore throat severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All sore throat severity assessment values were recorded in questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.|Change from baseline in 15, 30, 60,120, 180, and 240 minutes|The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.||Score on scale||Standard Error|Least Squares Mean
643199|NCT02246166|Secondary|Global Assessment of Treatment|After completing the 4 hours symptom severity assessments, participants evaluated their treatment response on a 5-point scale by answering the question: “How well did the test medication control your symptoms?” (0-ineffective, 1-poor, 2-fair, 3-good, or 4-excellent).|4 hours|The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.||Participants|||Number
643200|NCT02246166|Primary|Symptom Severity Assessment at 4 Hours|"Symptom severity assessment was determined by TSS, TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.
TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.
Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 4 hours post product use."|4 hours|The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.||Score on scale||Standard Error|Least Squares Mean
643201|NCT02246166|Primary|Symptom Severity Assessment at 3 Hours|"Symptom severity assessment was determined by TSS, TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.
TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.
Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 3 hours post product use."|3 hours|The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.||Score on scale||Standard Error|Least Squares Mean
643202|NCT02246166|Primary|Symptom Severity Assessment at 2 Hours|"Symptom severity assessment was determined by TSS, TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.
TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.
Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 2 hours post product use."|2 hours|The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.||Score on scale||Standard Error|Least Squares Mean
643203|NCT02246166|Primary|Symptom Severity Assessment at 1 Hour|"Symptom severity assessment was determined by TSS, TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.
TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.
Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 1hour post product use."|1 hour|The primary population for assessment of efficacy was the intent to treat (ITT) population. The intent-to-treat (ITT) population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.||Score on scale||Standard Error|Least Squares Mean
643204|NCT02246166|Primary|Symptom Severity Assessment at 30 Minutes|"Symptom severity assessment was determined by TSS, TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.
TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.
Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 30 minutes post product use."|30 minutes|The primary population for assessment of efficacy was the intent to treat (ITT) population. The intent-to-treat (ITT) population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.||Score on scale||Standard Error|Least Squares Mean
643304|NCT02241889|Secondary|Number of Carbohydrate Treatments|Assess the number of rescue carbohydrate treatments.|Entire 21 hour study duration excluding the first four hours|Data was analyzed from 21 subjects that completed all 3 visits and visits went to completion. No data was analyzed from the two subjects that did not complete all visits.||carbohydrate treatments||95% Confidence Interval|Mean
643205|NCT02246166|Primary|Symptom Severity Assessment at 15 Minutes|"Symptom severity assessment was determined by Total Sum Score (TSS), TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.
TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.
Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 15 minutes post product use."|15 minutes|The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.||Score on scale||Standard Error|Least Squares Mean
643206|NCT02246114|Primary|Primary Outcome of Serum Cotinine Levels|The primary outcome is the difference in serum cotinine levels between the intervention and control groups at the end of the trial.|1 year|Only 1 subject enrolled in this study and she terminated early due to miscarriage at 9 weeks.|||||
643207|NCT02246062|Other Pre-specified|Impact of Preanesthetic Information and Behavioral Intervention Using Smartphone Application on Anxiety of Children Measure by m-YPAS.|The level of child's anxiety will be measure by modified Yale Preoperative Anxiety Scale (m-YPAS). The total score of m-YPAS was calculated according to what was originally proposed by Kain et al. The total scores range from 23,4 until 100. Cut-off scores to classify patients with or without anxiety were: without anxiety (23.4 - 30), with anxiety (> 30).|Immediately before induction of anesthesia|||units on a scale m-YPAS||Standard Deviation|Mean
643208|NCT02246062|Other Pre-specified|Impact of Preanesthetic Information and Behavioral Intervention Using Smartphone Application on Anxiety of Children Measure m-YPAS.|The level of child's anxiety will be measure by modified Yale Preoperative Anxiety Scale (m-YPAS). The total score of m-YPAS was calculated according to what was originally proposed by Kain et al. The total scores range from 23,4 until 100. Cut-off scores to classify patients with or without anxiety were: without anxiety (23.4 - 30), with anxiety (> 30).|Immediately before entering operation room|||units on a scale m-YPAS||Standard Deviation|Mean
643209|NCT02246062|Primary|Impact of Preanesthetic Information and Behavioral Intervention Using Smartphone Application on Anxiety of Children Measure by m-YPAS.|The level of child's anxiety will be measure by modified Yale Preoperative Anxiety Scale (m-YPAS). The total score of m-YPAS was calculated according to what was originally proposed by Kain et al. The total scores range from 23,4 until 100. Cut-off scores to classify patients with or without anxiety were: without anxiety (23.4 - 30), with anxiety (< 30).|24 hours before surgery|||units on a scale m-YPAS||Standard Deviation|Mean
643210|NCT02245412|Secondary|To Evaluate the Pharmacokinetic (PK) Parameters of IV ALXN1007|Tmax, Cmax, total body clearance (CLR).|Treatment Period (8 weeks) and Follow-up Period (180days).||||||
643211|NCT02245412|Primary|Overall Acute GVHD Response Rate at Day 28|Proportion of subjects with overall acute GVHD response|day 28|One of the patients in the 10 mg/kg once weekly group was prematurely discontinued from the Treatment Period after receiving a single infusion of ALXN1007 due to lack of confirmed GI GVHD by biopsy.||Participants|||Count of Participants
643212|NCT02245360|Secondary|Change of Phleum Pratense Specific Immunoglobulin E (IgE) From Baseline to End of Treatment|measurement of IgE in serum|baseline versus end of treatment (approx. 60 days)|In each treatment arm/group 1 subject was excluded from the analyzed sample due to missing post-baseline efficacy data.||UA/ml||Standard Deviation|Mean
643213|NCT02245360|Primary|The Primary Efficacy Endpoint is Change From Baseline to End of Treatment of Phleum Pratense Specific Immunoglobulin G4 (IgG4) in Serum|measurement of IgG4 in serum|baseline versus end of treatment (approx. 60 days)|In each treatment arm/group 1 subject was excluded from the analyzed sample due to missing post-baseline efficacy data.||mgA/L||Standard Deviation|Mean
643214|NCT02244840|Secondary|Convenience|Questionnaires|3 minute||||||
643215|NCT02244840|Primary|Anal Resting Pressure Change|before and after bidet/sitz bath for 3 minute|3 minute|||mmHg||Standard Deviation|Mean
643216|NCT02244619|Post-Hoc|Hospital Length of Stay (LOS)|Total hospital length of stay was calculated as (hospital discharge moment - hospital admission moment). Hospital length of stay is reported in hours.|Pre-op admission to hospital discharge|||Hours||Inter-Quartile Range|Median
643217|NCT02244619|Post-Hoc|Post-Anesthesia Care Unit (PACU) Length of Stay, Hours|PACU length of stay was calculated as (PACU discharge moment - PACU admit moment). PACU length of stay is reported in hours.|PACU admission time until PACU discharge time|||Hours||Inter-Quartile Range|Median
643218|NCT02244619|Other Pre-specified|Time to First Rescue Opioid (PRN Order)||During post-op period up to 24 hrs after surgery|||Minutes||Inter-Quartile Range|Median
643219|NCT02244619|Other Pre-specified|Time to First Ambulation - 10 Feet||During post-op period up to 24 hours after surgery|||Hours||Inter-Quartile Range|Median
643220|NCT02244619|Other Pre-specified|Post-operative Nausea and Vomiting||During post-op period up to 24 hrs after surgery|||Participants|||Count of Participants
643221|NCT02244619|Secondary|Patient-rated Pain in the Post-operative Period|Patient-rated pain in the post-operative period was collected using a 10-point visual analog scale (VAS). A score of 0 indicates no pain; higher scores indicate greater pain. Minimum score for each VAS measurement is 0; Maximum score for each VAS measurement is 10. VAS scores were averaged for each patient.|Standard-of-care post-op assessment intervals during post-op period up to 24 hrs after surgery|||Visual analog pain scale (0-10)||Inter-Quartile Range|Median
643222|NCT02244619|Primary|Total Post-operative Use of Opioids|Post-operative use of opioids, measured in morphine milligram equivalent (MME) units|During post-op period up to 24 hrs after surgery|||Morphine milligram equivalents (MME)||Inter-Quartile Range|Median
643223|NCT02244580|Secondary|Number of Patients With Ki-67 Determined by MammaTyper™ Compared to Local Ki-67 Eyeballed Assessment for Luminal Tumors and Correlation to Rate of Patients With Regard to OS and DDFS|Superiority of outcome prediction for MammaTyper™ Ki-67 over local Ki-67 eyeballed assessment for Luminal tumors with regard to OS and DDFS|5 years|||Hazard ratio||95% Confidence Interval|Number
643224|NCT02244580|Secondary|Number of Patients With High Ki-67 and Prognosis on Outcome for DDFS and OS (Measured by Hazard Ratio)|High Ki-67 is prognostic for worse outcome for DDFS and OS (measured by hazard ratio)|5 years|||Hazard ratio||95% Confidence Interval|Number
648275|NCT02107014|Primary|Change in IL-12p70 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].|||pg/mL||95% Confidence Interval|Median
643225|NCT02244580|Primary|5 Year Distant Disease Free Survival (DDFS) Assessed as Rate of Patients Without Distant Metastases in Subgroup Luminal A vs. Combined Subgroup (Luminal B, HER2 Positive, Triple Negative), Based on Subtyping With MammaTyper™|Tumor material of breast cancer patients will be newly assessed by MammaTyper™ and 5 year DDFS will be calculated new according to new subgrouping (Luminal A vs. combined subgroup (Luminal B, HER2 positive, triple negative))|5 year from the date of patient randomisation|||percentage of analyzed participants|||Number
643226|NCT02243943|Secondary|Sedation|using the Leiden observer alertness score (1 alert - 5 sedated)|45 minutes post surgery|||sedation scale (1 alert - 5 sedated)||95% Confidence Interval|Mean
643227|NCT02243943|Secondary|Pain|using the 1-10 numeric rating scale|45 minutes post surgery|||Numeric rating scale. 1(low)-10(maximum)||95% Confidence Interval|Mean
643228|NCT02243943|Primary|Mean Lowest Saturation|Mean saturation is the mean value of the beat-to-beat Hb-oxygen saturation measured by finger pulse oximeter as measured in the first 45 min in the recovery room following surgery|45 minutes post surgery|||percentage of oxygen saturation||95% Confidence Interval|Mean
643229|NCT02243293|Secondary|Percentage of Participants With Post-treatment Relapse|Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment, excluding reinfection.|From the end of treatment through 12 weeks after the last dose of study drug|All participants who received at least 1 dose of study drug (ITT population) with evaluable data, completed treatment, and had HCV RNA <LLOQ at the final treatment visit.||percentage of participants||95% Confidence Interval|Number
643230|NCT02243293|Secondary|Percentage of Participants With On-treatment Virologic Failure|On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.|Up to end of treatment (treatment week 8, 12 or 16 depending on arm) or premature discontinuation from treatment|All participants who received at least 1 dose of study drug (ITT population) with evaluable data.||percentage of participants||95% Confidence Interval|Number
643231|NCT02243293|Secondary|Percentage of Participants With Sustained Virologic Response 4 Weeks Post-treatment (SVR4)|SVR4 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 4 weeks after the last dose of study drug.|4 weeks after the last actual dose of study drug|All participants who received at least 1 dose of study drug (ITT population) with evaluable data; participants with missing data after backwards imputation were imputed as nonresponders.||percentage of participants||95% Confidence Interval|Number
643232|NCT02243293|Primary|Percentage of Genotype 2 (GT2) Direct-acting Antiviral Agents (DAA)-Naive Participants (in Part 4, Arm S1) With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) as Compared to Historical Control|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of study drug|All participants who received at least 1 dose of study drug (ITT population) with evaluable data; participants with missing data after backwards imputation were imputed as nonresponders.||percentage of participants||95% Confidence Interval|Number
643233|NCT02243293|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of study drug|All participants who received at least 1 dose of study drug (ITT population) with evaluable data; participants with missing data after backwards imputation were imputed as nonresponders.||percentage of participants||95% Confidence Interval|Number
643234|NCT02243280|Secondary|Percentage of Participants With Post-treatment Relapse|Post-treatment relapse was defined as confirmed hepatitis C virus ribonucleic acid (HCV RNA) greater than or equal to the lower limit of quantitation (≥ LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment.|From the end of treatment through 12 weeks after the last dose of study drug|All participants who received at least 1 dose of study drug, completed treatment, and had HCV RNA <LLOQ at the final treatment visit||percentage of participants||95% Confidence Interval|Number
643235|NCT02243280|Secondary|Percentage of Participants With On-treatment Virologic Failure|The percentage of participants with on-treatment virologic failure (defined as confirmed hepatitis C virus ribonucleic acid (HCV RNA) greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA < LLOQ during treatment), confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.|Screening, Day 1, Day 3, treatment weeks 1, 2, 4, 6, 8, 10, and 12 or premature discontinuation from treatment|Intention-to-treat population: all participants who received at least 1 dose of study drug||percentage of participants||95% Confidence Interval|Number
643236|NCT02243280|Secondary|Percentage of Participants With Sustained Virologic Response (SVR) 4 Weeks Post-treatment|The percentage of participants with sustained virologic response (plasma hepatitis C virus ribonucleic acid [HCV RNA] less than the lower limit of quantification [<LLOQ]) 4 weeks after the last dose of study drug.|4 weeks after the last actual dose of study drug|Intention-to-treat population: all participants who received at least 1 dose of study drug||percentage of participants||95% Confidence Interval|Number
643237|NCT02243280|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks Post-treatment|The percentage of participants with sustained virologic response (plasma hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of study drug|Intention-to-treat population: all participants who received at least 1 dose of study drug||percentage of participants||95% Confidence Interval|Number
643238|NCT02243202|Other Pre-specified|Percentage of Participants With Weight Loss More Than Equal to (>=) 10 Percent at Week 26|Percentage of participants with weight loss >= 10 percent at week 26.|Week 26|The mITT analysis set included all randomized participants who received at least 1 dose of double-blind study agent.||Percentage of Participants|||Number
644905|NCT02196714|Secondary|Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose|Change in Mean Chemistry Parameters (±SD) from Pre-dose to 12 Hours Post-dose|12 hours|Safety Population||IU/L||Standard Deviation|Mean
643239|NCT02243202|Other Pre-specified|Change From Baseline in Pulse Rate at Week 26|Change from baseline in pulse rate at week 26|Week 26|The modified intent-to-treat (mITT) analysis set included all randomized participants who received at least 1 dose of double-blind study agent. N=number of participants analysed is the total participants who were evaluable for this outcome measure.||Beats Per Minute (Beats/Min)||Standard Error|Least Squares Mean
643240|NCT02243202|Other Pre-specified|Change From Baseline in Diastolic Blood Pressure (DBP) at Week 26|Change from baseline in diastolic blood pressure (DBP) at week 26.|Week 26|The mITT analysis set included all randomized participants who received at least 1 dose of double-blind study agent. N=number of participants analysed is the total participants who were evaluable for this outcome measure.||mmHg (millimeters of mercury)||Standard Error|Least Squares Mean
643241|NCT02243202|Secondary|Absolute Change From Baseline in Body Weight at Week 26|Absolute change from baseline in body weight was analysed at week 26.|Week 26|The mITT analysis set included all randomized participants who received at least 1 dose of double-blind study agent. N=number of participants analysed is the total participants who were evaluable for this outcome measure.||Kilogram (Kg)||Standard Error|Least Squares Mean
643242|NCT02243202|Secondary|Change From Baseline in Systolic Blood Pressure at Week 26|Change from baseline in systolic blood pressure was analysed at week 26.|Week 26|The mITT analysis set included all randomized participants who received at least 1 dose of double-blind study agent. N=number of participants analysed is the total participants who were evaluable for this outcome measure.||mmHg (millimeters of mercury)||Standard Error|Least Squares Mean
643243|NCT02243202|Secondary|Percentage of Participants With Weight Loss More Than Equal to (>=) 5 Percent at Week 26|Percentage of participants with weight loss >= 5 percent were analysed at week 26.|Week 26|The mITT analysis set included all randomized participants who received at least 1 dose of double-blind study agent. N=number of participants analysed is the total participants who were evaluable for this outcome measure.||percentage of participants|||Number
643244|NCT02243202|Primary|Percent Change From Baseline in Body Weight at Week 26|The percent change from baseline in body weight at Week 26 was analysed.|Week 26|The modified intent-to-treat (mITT) analysis set included all randomized participants who received at least 1 dose of double-blind study agent. N=number of participants analysed is the total participants who were evaluable for this outcome measure.||Percent Change||Standard Error|Least Squares Mean
643245|NCT02243176|Secondary|Change From Baseline in Body Weight|Secondary objective: Effects of saxagliptin versus acarbose on the additional parameters, by measure change from baseline in fasting plasma glucose, 2h postprandial glucose, β-cell function, body weight at week 24|From baseline to 24 week|The Full analysis set included all randomized subjects who took at least 1 randomized IP dose, and had at least 1 non-missing baseline and 1 post-baseline efficacy data assessments.||kg||Standard Error|Least Squares Mean
643246|NCT02243176|Secondary|Change From Baseline in HOMA-β|Secondary objective: Effects of saxagliptin versus acarbose on the additional parameters, by measure change from baseline in fasting plasma glucose, 2h postprandial glucose, β-cell function was estimated by the Homeostasis model assessment-β (HOMA-β), which was defined as fasting insulin (mU/mL) x 20 / (fasting glucose (mmol/mL) - 3.5, body weight at week 24|From baseline to 24 week|The Full analysis set included all randomized subjects who took at least 1 randomized IP dose, and had at least 1 non-missing baseline and 1 post-baseline efficacy data assessments.||mU/mmol||Standard Error|Least Squares Mean
643247|NCT02243176|Secondary|Change From Baseline in 2H Postprandial Glucose (2HPPG)|Secondary objective: Effects of saxagliptin versus acarbose on the additional parameters, by measure change from baseline in fasting plasma glucose, 2h postprandial glucose, β-cell function, body weight at week 24|From baseline to 24 week|The Full analysis set included all randomized subjects who took at least 1 randomized IP dose, and had at least 1 non-missing baseline and 1 post-baseline efficacy data assessments.||mmol/l||Standard Error|Least Squares Mean
643248|NCT02243176|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|Secondary objective: Effects of saxagliptin versus acarbose on the additional parameters, by measure change from baseline in fasting plasma glucose, 2h postprandial glucose, β-cell function, body weight at week 24|From baseline to 24 week|The Full analysis set included all randomized subjects who took at least 1 randomized IP dose, and had at least 1 non-missing baseline and 1 post-baseline efficacy data assessments.||mmol/l||Standard Error|Least Squares Mean
643249|NCT02243176|Secondary|Proportion (%) of Patients Achieving HbA1c<7.0% Without GI Adverse Events|Secondary Objective: Assessment of any gastrointestinal adverse events of saxagliptin versus acarbose. by measure proportion (%) of patients achieving HbA1c<7.0% without GI adverse events.|Whole study duration|The Full analysis set included all randomized subjects who took at least 1 randomized IP dose, and had at least 1 non-missing baseline and 1 post-baseline efficacy data assessments.||percentage of participants|||Number
643250|NCT02243176|Secondary|Proportion (%) of Patients Achieving a Therapeutic Glycemic Response Defined as HbA1c<7.0%|Secondary Objective: Effects of saxagliptin versus acarbose on the additional parameters, by measure proportion (%) of patients achieving a therapeutic glycemic response defined as HbA1c<7.0%|24 weeks|The Full analysis set included all randomized subjects who took at least 1 randomized IP dose, and had at least 1 non-missing baseline and 1 post-baseline efficacy data assessments.||percentage of participants|||Number
643251|NCT02243176|Secondary|Proportion (%) of Patients With Any GI Adverse Events|Secondary Objective: Assessment of any gastrointestinal adverse events of saxagliptin versus acarbose. by measure proportion (%) of patients with any gastrointestinal adverse events.|24 weeks|The Full analysis set included all randomized subjects who took at least 1 randomized IP dose, and had at least 1 non-missing baseline and 1 post-baseline efficacy data assessments.||percentage of participants|||Number
643252|NCT02243176|Primary|Absolute Change From Baseline in HbA1c at Week 24 (DAO)|The primary endpoint was analyzed based on Per protocol analysis set as the supportive analysis.|From baseline to 24 week|The Per Protocol analysis set was a subset of the Full analysis set that included subjects who did not have significant protocol deviations that affect the study outcome. The exclusions from the PP analysis set was determined prior to database lock.||% (HbA1c)||Standard Error|Least Squares Mean
643290|NCT02242305|Secondary|Global Assessment of Tolerability by Investigator on a 4-point Scale|The endpoint presents global assessment of tolerability by subject on a 4-point scale. Global assessment of tolerability regarding all episodes treated by the subject after 3 days of treatment (good, satisfactory, not satisfactory, bad).|Day 3.|Safety Set (SFS): All randomized subjects who took at least one dose of study medication.||Participants|||Number
643253|NCT02243176|Primary|Absolute Change From Baseline in HbA1c at Week 24 (DAO)|Primary Objective: Efficacy of saxagliptin plus metformin on glycemic control compared with acarbose plus metformin in patients with T2D inadequately controlled with metformin. By Measure absolute change from baseline in HbA1c at Week 24|From baseline to 24 week|The Full analysis set included all randomized subjects who took at least 1 randomized IP dose, and had at least 1 non-missing baseline and 1 post-baseline efficacy data assessments.||% (HbA1c)||Standard Error|Least Squares Mean
643254|NCT02243046|Primary|Dental Plaque Scores|Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|6 months (from Baseline)|||units on a scale||Standard Deviation|Mean
643255|NCT02243046|Primary|Dental Plaque Scores|Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|3 months (from Baseline)|||units on a scale||Standard Deviation|Mean
643256|NCT02243046|Primary|Dental Plaque Scores|Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|Baseline|||units on a scale||Standard Deviation|Mean
643257|NCT02243046|Primary|Gingivitis Scores|Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)|6 months (from Baseline)|||units on a scale||Standard Deviation|Mean
643258|NCT02243046|Primary|Gingivitis Scores|Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)|3 months (from Baseline)|||units on a scale||Standard Deviation|Mean
643259|NCT02243046|Primary|Gingivitis Scores|Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)|Baseline|||units on a scale||Standard Deviation|Mean
643260|NCT02243007|Secondary|Local Control Rate|The number of participants achieving local control. The local control rate is defined as the number of participants achieving stable disease, partial response, or a complete response.|2 Years|Data not available. Study was terminated before endpoint was able to be evaluated|||||
643261|NCT02243007|Secondary|Rate of Pathologic Downstaging|The number of participants achieving a reduction in the pathological staging of the primary cancer.|2 Years|Data not available. Study was terminated before endpoint was able to be evaluated|||||
643262|NCT02243007|Secondary|Correlation of Biomarkers With PFS|Analysis of the correlation between selected bio-markers and progression free survival.|2 Years|Data not available. Study was terminated before endpoint was able to be evaluated|||||
643263|NCT02243007|Secondary|30-day Post-operative Mortality Rate|Number of patients who died following surgery.|30 Days|Study ended prematurely, no results available|||||
643264|NCT02243007|Secondary|Surgical Morbidity Rate|Number of patients experiencing a specific surgery related morbidity|within 30 days of surgery|Study ended prematurely, no results available|||||
643265|NCT02243007|Secondary|Number of Participants With Serious and Non-Serious Adverse Events|Number of Participants with Serious and Non-Serious Adverse Events from baseline to 28 days|Baseline, 28 Days|||participants|||Number
643266|NCT02243007|Secondary|Overall Survival Rate|Overall survival rate at five years using Kaplan-Meier survival analysis|Baseline, 5 Years|Study terminated before endpoint was reached, no data available|||||
643267|NCT02243007|Secondary|Pathologic Complete Response Rate (pCR).|Number of patients achieving pathologic complete response at 18 months. Pathologic complete response is defined as the absence of residual invasive disease in the panaceas and in the regional lymph nodes.|18 Months|No Data available. Study terminated before any patients reached 18 months of follow-up. Patients were not able to be evaluated for response.|||||
643268|NCT02243007|Primary|Survival Rate at 18 Month|Number of participants surviving after 18 months of study follow-up|18 Month|||Participants|||Count of Participants
643269|NCT02242994|Secondary|Error Rate of Communication|Amount of typing errors per sentence|At time of experiment|||errors||Standard Deviation|Mean
643270|NCT02242994|Primary|Speed of Communication|Measure time (in minutes) to type 3 pre-set sentences|Immediately|||minutes||Standard Error|Mean
643271|NCT02242643|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Related = symptom assessed by the investigator as causally related to the study vaccination.|During the entire study period (Days 0 -180)|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and for whom data were available.||Subjects|||Number
643291|NCT02242305|Secondary|Number of Patients With Adverse Events|The endpoint presents number of patients with Adverse Events (AEs). Subjects were required to report spontaneously any AEs as well as the time of onset, end and intensity of these events. Specific questions were asked wherever required or useful to more precisely describe an AE. An Adverse Event was termed serious when one of the following applied: death, directly lifethreatening, continuous or severe impairment, in-patient treatment or prolonging of hospitalization, congenital deformity and other similar medical criteria.|Up to 3 days.|Safety Set (SFS): All randomized subjects who took at least one dose of study medication.||Participants|||Number
643272|NCT02242643|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)|An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 unsolicited AE was defined as an event that prevented normal activity. Related unsolicited AE was defined as an event assessed by the investigator to be causally related to the study vaccination.|During a 28-day (Days 0-27 for primed and unprimed subjects and Days 28-56 for unprimed subjects) post-vaccination period|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and for whom data were available.||Subjects|||Number
643273|NCT02242643|Secondary|Number of Subjects Reporting the Occurrence of Any and Related Potential Immune-Mediated Disease (pIMDs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)|pIMDs are a subset of adverse events (AEs) that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Related = symptom assed by the investigator as causally related to the study vaccination.|During the entire study period (Days 0 -180)|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and for whom data were available.||Subjects|||Number
643274|NCT02242643|Secondary|Number of Subjects Reporting the Occurrence of All Medically Attended Events (MAEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed).|MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s).|During the entire study period (Days 0 -180)|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and for whom data were available.||Subjects|||Number
643275|NCT02242643|Secondary|Number of Subjects Reporting Any Fever Following Each Dose and Across Doses.|"Any Fever = all subjects with a documented temperature of ≥38.0°C /100.4°F by axillary route and all subjects reporting temperature < 38.0°C but with missing values for at least one day during the solicited period.
Grade 3 fever was defined as temperature greater than (>) 39.0°C."|During a 2-day (Days 0-1) follow-up period after each vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and for whom data were available.||Subjects|||Number
643276|NCT02242643|Secondary|Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)|Duration was defined as number of days with any grade of local and general symptoms.|During the 7-day (Days 0-6) follow-up period after each vaccination.|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and for whom data were available.||Days||Full Range|Median
643277|NCT02242643|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)|Solicited general symptoms assessed were drowsiness, irritability/fussiness, loss of appetite and fever. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 irritability/fussiness was defined as crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite was defined as not eating at all. Grade 3 drowsiness was defined as drowsiness that prevented normal activity. Any fever was defined as subjects with a documented temperature of greater than or equal to (≥) 38°C/100.4°F by any route and all subjects reporting temperature less than (< )38°C but with missing values for at least one day during the solicited period. Grade 3 fever was defined as temperature greater than (>) 39.0°C.|During the 7-day (Days 0-6) follow-up period after each vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and for whom data were available.||Subjects|||Number
643278|NCT02242643|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity and all subjects reporting ‘Yes’ for solicited symptom occurred but with missing values for at least one day during the solicited period. Grade 3 pain = Cried when limb is moved/spontaneously painful. Grade 3 redness and swelling was greater than 100 millimeters (mm) i.e. >100mm.|During a 7-day (Day 0 – Day 6) follow-up period after each vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and for whom data were available.||Subjects|||Number
643279|NCT02242643|Secondary|Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)|MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/California/7/2009 (H1N1) HI, A/Texas/50/2012 (H3N2) HI, B/Massachusetts/2/2012 (Yamagata) HI and B/Brisbane/60/2008 (Victoria).|28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects)|The ATP cohort for immunogenicity included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.||Fold increase||95% Confidence Interval|Geometric Mean
643303|NCT02241889|Secondary|Percent of Time With Sensed Glucose < 50 mg/dl|Assess the percent of time that the Dexcom G4 or G4 Share reported sensor glucose values less than 50 mg/dl using Dexcom sensor downloads.|Entire 21 hour study duration excluding the first four hours|Data was analyzed from 21 subjects that completed all 3 visits and visits went to completion. No data was analyzed from the two subjects that did not complete all visits.||percent of time||95% Confidence Interval|Mean
643280|NCT02242643|Secondary|Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)|A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/California/7/2009 (H1N1) HI, A/Texas/50/2012 (H3N2) HI, B/Massachusetts/2/2012 (Yamagata) HI and B/Brisbane/60/2008 (Victoria).|28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.||Subjects|||Number
643281|NCT02242643|Secondary|Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40. The vaccine strains assessed were Flu A/California/7/2009 (H1N1) HI, A/Texas/50/2012 (H3N2) HI, B/Massachusetts/2/2012 (Yamagata) HI and B/Brisbane/60/2008 (Victoria).|At Day 0 and 28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects)|The ATP cohort for immunogenicity included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.||Subjects|||Number
643282|NCT02242643|Secondary|Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)|Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were A/California/7/2009 (H1N1), A/Texas/50/2012 (H3N2), B/Massachusetts/2/2012 (Yamagata) and B/Brisbane/60/2008 (Victoria).|At Day 0 and 28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.||Titers||95% Confidence Interval|Mean
643283|NCT02242643|Primary|Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains.|HI antibody titres were expressed as geometric mean titers (GMTs) and adjusted GMT ratios. The vaccine strains assessed were Flu A/California/7/2009 (H1N1) HI, A/Texas/50/2012 (H3N2) HI, B/Massachusetts/2/2012 (Yamagata) HI and B/Brisbane/60/2008 (Victoria).|At 28 days after the last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.||Titers||95% Confidence Interval|Geometric Mean
643284|NCT02242643|Primary|Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains|"Antibody titers were expressed as Seroconversion rate (SCR) and SCR difference. SCR was defined as the proportion of vaccinees who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer.
The vaccine strains assessed were Flu A/California/7/2009 (H1N1), A/Texas/50/2012 (H3N2), B/Massachusetts/2/2012 (Yamagata) and B/Brisbane/60/2008 (Victoria)."|28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.||Subjects|||Number
643285|NCT02242630|Other Pre-specified|Safety|Safety of either methylprednisolone or triamcinolone, either related to the medication received or the dose received.|6 weeks||||||
643286|NCT02242630|Secondary|Change in Subject Reported Shoulder Pain as Measured by the Visual Analogue Scale|Change in shoulder pain reported by the subject after injection at 6 weeks. The subject will report shoulder pain on a scale from 0 (no pain) to 10 (maximal pain) after injection. A 2 point change is expected.|6 weeks|||units on a scale||95% Confidence Interval|Mean
643287|NCT02242630|Primary|Change in Shoulder Function, as Measured by the QuickDASH ®|The primary outcome of this study will be to compare the dose and type of intrabursal corticosteroid received to improvements in a functional measure of the shoulder, the QuickDASH. The QuickDASH is a validated questionnaire of shoulder function consisting of 11 questions with a score from 100 (maximal dysfunction) to 0 (no dysfunction). It is expected that improvements will lead to at least a 10 point improvement (minimal clinically important difference)|6 weeks|||units on a scale||95% Confidence Interval|Mean
643288|NCT02242305|Secondary|Percentage of Event for Time to Therapeutic Effect|This outcome measure presents percentage of event for time to therapeutic effect defined as the time that the first VAS reduction occurred.|From time of the first dose to the time that the first VAS reduction occurred, up to 180 minutes after the first dose on Day 1.|Per-Protocol Set (PPS): All randomized subjects in FAS without any major protocol violation were included into the per protocol set, including those subjects who had good treatment compliance (80% to 120%), who did not take any restriction medications during the study period and whose Case Report Form (CRF) was complete as requested.||Percentage of event|||Number
643289|NCT02242305|Secondary|Number of Subjects With Clinical Relevant Abnormalities for Laboratory, Vital Signs, ElectroCardioGram (ECG) and Physical Examination|Number of patients with findings in clinical relevant abnormalities for laboratory, vital signs, ElectroCardioGram (ECG) and physical examination. Relevant findings or worsening of baseline conditions were reported as Adverse Events (AEs).|Up to 3 days.|Safety Set (SFS): All randomized subjects who took at least one dose of study medication.||Participants|||Number
643724|NCT02229864|Secondary|Number of Subjects With All Myocardial Infarction (MI)|All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI).|0 to 37 Days|||Participants|||Count of Participants
643292|NCT02242305|Secondary|Global Assessment of Efficacy by Patient on 4-point Scale|The endpoint presents global assessment of efficacy: by the patient after 3 days of treatment using a 4-point rating scale (good, satisfactory, not satisfactory, and bad).|Post 3 days of treatment.|Full Analysis Set (FAS): According to the Intent-to-Treat (ITT) principle, all randomized subjects who took at least one dose of study medication and who provided any data for the primary efficacy endpoint were used in FAS.||Participants|||Number
643293|NCT02242305|Secondary|Change of the Pain Frequency Assessed on 4-stage Verbal Rating Scale (VRS)|The endpoint presents frequency improvement, change of the pain frequency from baseline pain frequency for each of Day 1 – 3. Baseline pain frequency meant the pain frequency before randomization on visit 1. VRS score of Day 3 change from baseline was calculated. A retrospective assessment was entered by the patient in the patient diary, again once daily in the evening, of the pain frequency over the preceding 24 hour period. This was based on a 4-stage Verbal Rating Scale (VRS) with the following scores to the question: “How many times have the spasm-like pains occurred today?” 0 = not at all, 1 = 1-2 times, 2 = 3-5 times, 3 = more than 5 times.|Up to 3 days.|Per-Protocol Set (PPS): All randomized subjects in FAS without any major protocol violation were included into the per protocol set, including those subjects who had good treatment compliance (80% to 120%), who did not take any restriction medications during the study period and whose Case Report Form (CRF) was complete as requested.||Units on a scale||Standard Deviation|Mean
643294|NCT02242305|Primary|Change of the Mean Pain Intensity Score Measured on a Visual Analogue Scale (VAS) Within 3 Days (and Within 1 Day) - ANCOVA|"The endpoint presents change of the mean Visual Analogue Scale (VAS) of pain intensity score, recorded daily by the patient in the evening in his/her patient diary describing pain intensity during the previous 24 hours, from the baseline pain intensity. The baseline pain intensity was the pain intensity of first episode on Day 1 after randomization before taking study medication. The mean VAS pain intensity score was calculated for the 3-day treatment period. A VAS for describing the pain intensity was used (VAS: maximum score of 10 cm, the score from 0 - 10 cm reaching from no pain to the most severe pain imaginable)."|3 days (1 day)|Per-Protocol Set (PPS): All randomized subjects in FAS without any major protocol violation were included into the per protocol set, including those subjects who had good treatment compliance (80% to 120%), who did not take any restriction medications during the study period and whose Case Report Form (CRF) was complete as requested.||Units on a scale|||Number
643295|NCT02242019|Primary|Change in Millimeters (mm) of Clear Nail Bed|Millimeter (mm) of clear nail from the base of the toenail was determined from digital photographs of the toenail using a computer program. Change in mm of clear nail bed was calculated as the difference in mm of clear nail bed from baseline measurement to the measurement at 36 weeks after the end of the procedure administration phase. An increase in mm of clear nail between the two measurement points indicates that the toenail has improved and is positive for study success. A decrease in mm of clear nail between the two measurement points indicates that the toenail has worsened and is negative for study success.|Baseline and 36 Weeks|Some subjects had multiple toenails with onychomycosis disease involvement that were treated and analyzed, resulting in a total of 139 study toenails being analyzed.||millimeters (mm)|Participants|Standard Deviation|Mean
643296|NCT02242019|Secondary|Change in Percent (%) of Onychomycosis Disease Involvement|The percent (%) of the toenail that had onychomycosis disease involvement was determined. Change in the % of toenail onychomycosis disease involvement was calculated as the difference in the % of toenail onychomycosis disease involvement from baseline measurement to the measurement at 36 weeks after the end of the procedure administration phase. A decrease in the % of toenail onychomycosis disease involvement between the two measurement points indicates that the toenail onychomycosis involvement has decreased and is positive for study success. An increase in the % of toenail onychomycosis disease involvement between the two measurement points indicates that the toenail onychomycosis involvement has increased and is negative for study success.|Baseline and 36 Weeks|||percentage of disease involvement|Participants|Standard Deviation|Mean
643297|NCT02242019|Primary|Number of Toenails Attaining 3 Millimeters (mm) or More of Clear Nail Growth|Individual toenail success criteria was defined as 3 millimeter (mm) or more of clear nail growth at 36 weeks post-procedure administration as evaluated relative to baseline. Overall study success criteria was defined as an 60% or more of treated toenails meeting the individual success criteria.|Baseline and 36 Weeks|||toenails|Participants||Number
643298|NCT02241889|Secondary|Percent of Time of CBG>180 mg/dl|Assess the percent of time that the Contour Next BG meter reported blood glucose values greater than 180 mg/dl using meter downloads.|Entire 21 hour study duration excluding the first four hours|Data was analyzed from 21 subjects that completed all 3 visits and visits went to completion. No data was analyzed from the two subjects that did not complete all visits.||percentage of time||95% Confidence Interval|Mean
643299|NCT02241889|Secondary|Number of Events With CBG <50 mg/dl|Assess the total number of events that the Contour Next BG meter reported blood glucose values less than 50 mg/dl across all participants in each group.|Entire 21 hour study duration excluding the first four hours|Data was analyzed from 21 subjects that completed all 3 visits and visits went to completion. No data was analyzed from the two subjects that did not complete all visits.||occurrences of blood glucose < 50 mg/dl|||Number
643300|NCT02241889|Secondary|Number of Events With CBG Between 70 – 180 mg/dl|Assess the number of events that the Contour Next BG meter reported blood glucose values between 70-180 mg/dl using meter downloads.|Entire 21 hour study duration excluding the first four hours|Data was analyzed from 21 subjects that completed all 3 visits and visits went to completion. No data was analyzed from the two subjects that did not complete all visits.||# of events||95% Confidence Interval|Mean
643301|NCT02241889|Secondary|Number of Events Capillary Blood Glucose (CBG) <70 mg/dl|Number of events measured with capillary blood glucose <70 mg/dl.|Entire 21 hour study duration excluding the first four hours|Data was analyzed from 21 subjects that completed all 3 visits and visits went to completion. No data was analyzed from the two subjects that did not complete all visits.||occurrences of blood glucose < 70 mg/dl||95% Confidence Interval|Mean
643302|NCT02241889|Secondary|Percent of Time With Sensed Glucose > 180 mg/dl|Assess the percent of time that the Dexcom G4 or G4 Share reported sensor glucose values greater than 180 mg/dl using Dexcom sensor downloads.|Entire 21 hour study duration excluding the first four hours|Data was analyzed from 21 subjects that completed all 3 visits and visits went to completion. No data was analyzed from the two subjects that did not complete all visits.||percent of time||95% Confidence Interval|Mean
643305|NCT02241889|Secondary|Mean of the Mean Sensed Glucose Per Participant|Assess the mean sensed glucose per participant using Dexcom sensor downloads.|Entire 21 hour study duration excluding the first four hours|Data was analyzed from 21 subjects that completed all 3 visits and visits went to completion. No data was analyzed from the two subjects that did not complete all visits.||mg/dl||95% Confidence Interval|Mean
643306|NCT02241889|Primary|Percent of Time With Sensed Glucose Between 70-180 mg/dl|Assess the percent of time that the Dexcom G4 or G4 Share reported sensor glucose values between 70-180 mg/dl using Dexcom sensor downloads.|from start of exercise (~hour 12) until study completion (hour 21)|Data was analyzed from 21 subjects that completed all 3 visits and visits went to completion. No data was analyzed from the two subjects that did not complete all visits.||percent of time||95% Confidence Interval|Mean
643307|NCT02241889|Primary|Percent of Time With Sensed Glucose < 70 mg/dl|Assess the percent of time that the Dexcom G4 or G4 Share reported sensor glucose values less than 70 mg/dl using Dexcom sensor downloads.|from start of exercise (~hour 12) until study completion (hour 21)|Data was analyzed from 21 subjects that completed all 3 visits and visits went to completion. No data was analyzed from the two subjects that did not complete all visits.||percentage of time||95% Confidence Interval|Mean
643308|NCT02241785|Secondary|Change in MSIS-29 Physical Impact Scores From Baseline (Day -1) to Reset Baseline (Week 8)|The MSIS-29 is a brief self-administered MS-specific instrument measuring physical (20 items) and mental/psychological (9 items) impact of MS. The physical score is generated by summing individual items and then transforming to a scale with a range of 0 to 100, where high scores indicate worse health.|Baseline (Day -1) to Reset Baseline (Week 8)|Intent-to-treat population: participants who received at least 1 infusion of study treatment and had an assessment.||units on a scale||Standard Deviation|Mean
643309|NCT02241785|Secondary|Pre- and Post-Natalizumab Infusion Annualized Relapse Rate (ARR) Comparison at Month 12|An MS relapse was defined as the onset of new or recurrent neurological symptoms lasting at least 24 hours, accompanied by new objective abnormalities on a neurological examination, and not explained solely by non-MS processes such as fever, infection, severe stress, or drug toxicity. 95% confidence interval is based on a Poisson regression model.|From 12 months prior to natalizumab infusion and 12 months post-natalizumab infusion|Intent-to-treat population: participants who received at least 1 infusion of study treatment and had an assessment.||relapses per subject-year||95% Confidence Interval|Number
643310|NCT02241785|Secondary|Proportion of Participants With NEDA From Week 8 (Reset Baseline) to Week 104|Proportion of participants with NEDA from Week 8 (Reset Baseline) to Week 104 (with no 12-week confirmed EDSS progression determined at Week 116). NEDA was defined as follows: no EDSS progression (12-week sustained); no relapses; no Gd+ lesions; no new or enlarging T2 hyperintense lesions over 48 weeks after resetting the Baseline at Week 8 to remove contribution of CUA lesions that occurred prior to Week 8, when natalizumab was not yet active. The EDSS quantifies disability in 8 functional systems. The final EDSS score is an ordinal clinical rating scale ranging from 0 (normal neurologic examination) to 10 (death due to MS) in half-point increments.|from Week 8 (Reset Baseline) to Week 104|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.|||||
643311|NCT02241785|Secondary|Change in T1 Unenhancing Lesion Volume and T2 Lesion Volume From Baseline (Day -1) to Reset Baseline (Week 8)|As measured by magnetic resonance imaging.|Baseline (Day -1) to Reset Baseline (Week 8)|Intent-to-treat population: participants who received at least 1 infusion of study treatment and had an assessment.||cc||Standard Deviation|Mean
643312|NCT02241785|Primary|Proportion of Participants With No Evidence of Disease Activity (NEDA) From Reset Baseline (Week 8) to Week 56|The proportion of participants with NEDA, defined as follows: no Expanded Disability Status Scale (EDSS) progression (12-week sustained); no relapses; no gadolinium enhancing (Gd+) lesions; no new or enlarging T2 hyperintense lesions over 48 weeks after resetting the Baseline at Week 8 to remove contribution of combined unique active (CUA) lesions that occurred prior to Week 8, when natalizumab was not yet active. The EDSS quantifies disability in 8 functional systems. The final EDSS score is an ordinal clinical rating scale ranging from 0 (normal neurologic examination) to 10 (death due to MS) in half-point increments.|Reset Baseline (Week 8) to Week 56|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.|||||
643313|NCT02241486|Primary|Pain Relief|Patients suffering from burn injuries will receive sublingual fentanyl spray (Subsys) to address procedural pain (dressing changes/minor debridement). It will be compared with a standard treatment regimen of oral morphine. The hypothesis is that the fentanyl spray will be more effective for the treatment of procedural pain in patients with burn injury.|60 min|No participants are included in this analysis because the trial was terminated prematurely. As a result, data to assess primary and secondary study aims are incomplete or entirely unavailable for summary or statistical comparisons.|||||
643314|NCT02241187|Secondary|Safety of Administration of PEGPH20 and Cetuximab|in close proximity to surgical resection of pancreatic adenocarcinoma. Safety with regards to operative and post-operative complications will be characterized.|1 year|The two participants accrued to this study were healthy participants. No participants were accrued on study for treatment. No data were collected.|||||
643315|NCT02241187|Primary|Effects of PEGPH20|administration on resectable pancreatic adenocarcinoma tumors. DW- and DCE-MRI and distribution of cetuximab will be used to study tumor permeability to small and larger molecules, respectively. Resected tumors will be carefully studied for evidence of stromal degradation.|1 year|The two participants accrued to this study were healthy participants. No participants were accrued on study for treatment. No data were collected.|||||
643316|NCT02240628|Secondary|Pain Intensity|"A blinded independent observer will rate pain on Propofol injection according to a pain scale.
No pain.
Mild pain(associated with facial expression of pain).
Moderate Pain(Pulling/withdrawal of arm).
Severe Pain(Screaming)."|During Propofol injection.|||participants|||Number
643317|NCT02240628|Primary|Number of Children in Each Group Who Don't Feel Pain or Have Mild Pain on Propofol Injection.||During propofol injection.|||participants|||Number
643364|NCT02239679|Other Pre-specified|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|52 Weeks after PDT #1|Analysis population consisted of observed data only||Participants|||Count of Participants
643318|NCT02240589|Secondary|Traumatic Brain Injury Quality of Life Anger (TBI QOL Anger)|The TBI-QOL Anger item bank includes 38 hierarchically ordered items designed to measure the full continuum of anger in a way which is both sensitive and appropriate for TBI. The TBI-QOL Anger item bank can be administered as a computer-adaptive test (CAT), allowing precise measurement of self-reported anger using only 4-8 adaptively selected items. Using CAT technology, an individual participant’s responses to the TBIQoL Anger scale generated a T-score (Mean=50; SD=10) with a range of 0 (lowest anger) to 100 (greatest anger).|Week 24|||scaled score||Standard Deviation|Mean
643319|NCT02240589|Secondary|Behavior Rating Inventory of Executive Function (BRIEF) Inhibit|The Behavior Rating Inventory of Executive Function (BRIEF) Inhibit subscale is a rating scale completed by the participant and independently by an observer that assesses the ability to control impulses (inhibitory control) and to stop engaging in a behavior. The frequency of behaviors indicated by items is rated on a 3-point scale (never, sometimes, often). The raw score for the Inhibit subscale is the sum of ratings for the 8 items included in this measure. This sum was converted to a T-score (mean=50; SD=10) for analysis. Higher scores suggest a higher level of dysfunction in a specific domain of executive functions.|Week 24|||t-score||Standard Deviation|Mean
643320|NCT02240589|Secondary|Stroop Interference|Stroop Interference Test is a neuropsychological test to assess a person's executive function. Specifically, the test is thought to reflect selective attention, cognitive flexibility and processing speed. The raw score for this measure is the number of items correctly identified within 45 seconds. The raw score was converted to a T-score (mean=50; SD=10) for analysis. Higher scores reflect better performance and less interference on reading ability.|Week 24|||t-score||Standard Deviation|Mean
643321|NCT02240589|Secondary|Trail Making Part B|Neuropsychological test of visual attention and executive functioning. The trail making tests are thought to reflect a variety of cognitive processes including attention, visual search and scanning, sequencing and shifting, psychomotor speed, abstraction, flexibility, ability to execute and modify a plan of action, and ability to maintain two trains of thought simultaneously. In Trails B, the participant is instructed to draw lines to connect numbers and letters in an alternating numeric and alphabetic sequence as rapidly as possible. Lower scores are better scores and the range of scores can be from 0 to no limit for Trail Making Test part B. This is a timed test and the number of seconds to complete the task is recorded. The unit of measure in seconds is converted to a scaled score (mean =10, SD = 3) using the Heaton et al. norms with lower scores indicating better performance.|Week 24|||scaled score||Standard Deviation|Mean
643322|NCT02240589|Secondary|BVMT-R Learning|Brief Visuospatial Memory Test-Revised (BVMT-R) Learning measures the correctly recalled designs (i.e., standard scoring of accuracy and location as described in the manual) over 3 learning trials. The Learning raw score is the sum of the higher number of correctly recalled designs on either Trial 2 or Trial 3 minus the number of correctly recalled designs on Trial 1. A higher score is a better score. The raw score was converted to a T-score (Mean=50; SD=10) for analysis.|Week 24|||t-score||Standard Deviation|Mean
643323|NCT02240589|Secondary|Brief Visuospatial Memory Test - Revised (BVMT-R) Delayed Recall|Brief Visuospatial Memory Test-Revised (BVMT-R) Delayed Recall measures the correctly recalled designs (i.e., standard scoring of accuracy and location as described in the manual) after a 25 minute delay. The delayed recall raw score ranges from 0 to 12 with 12 being the highest and best possible score. The raw score is converted to a T-score (Mean=50; SD=10) which was used for statistical analysis.|Week 24|||t-score||Standard Deviation|Mean
643324|NCT02240589|Secondary|CVLT-II Trials 1-5 Free Recall Total|Neuropsychological test used to assess an individual's verbal memory abilities. California Verbal Learning Test-Second Edition (CVLT-II) Trials 1-5 Free Recall Total measures the sum of all word list items correctly recalled on learning trials 1 through 5. This raw score is converted to a T-score (Mean=50; SD=10) which was used for statistical analysis. The total A1–5T score reflects accurate recall over the five learning trials of the first list, and is most often used as a summary index of learning on the CVLT-II, with higher scores reflecting better performance.|Week 24|||t-score||Standard Deviation|Mean
643325|NCT02240589|Primary|California Verbal Learning Test - Second Edition (CVLT-II) - Long Delay Free Recall|Neuropsychological test used to assess an individual's verbal memory abilities. The California Verbal Learning Test-Second Edition (CVLT-II) Long Delay Free Recall measures total word list items recalled after a 20-minute delay. The raw score is converted to a Z-score (Mean=0; SD=1) which was used for statistical analysis. Higher scores reflect worse performance (i.e., more recall errors) on this variable.|Week 24|||z-score||Standard Deviation|Mean
643326|NCT02240368|Secondary|Entropy Awaking|In each patient the Entropy values at the moment of first signs of awakening. The Entropy monitor provides a single dimensionless number, which ranges from 0 (equivalent to EEG silence) to 100 (deepest/highest level of anesthesia). A Entropy value between 40 and 60 indicates an appropriate level for general anesthesia, as recommended by the manufacturer|reported moment of awakening from anesthesia, an average of 1 hours after administration of Anesthesia|||units on a scale||Inter-Quartile Range|Median
643327|NCT02240368|Secondary|BISPECTRAL Index Awaking|In each patient the Bispectral index values at the moment of first signs of awakening.The Bispectral index monitor provides a single dimensionless number, which ranges from 0 (equivalent to EEG silence) to 100 (deepest/highest level of anesthesia). A BIS value between 40 and 60 indicates an appropriate level for general anesthesia, as recommended by the manufacturer|reported moment of awakening from anesthesia, an average of 1 hours after administration of Anesthesia|||units on a scale||Inter-Quartile Range|Median
643328|NCT02240368|Primary|Entropy|"The collected values of Entropy will generate a single prediction probability (PK) of agreement between Entropy vs end-tidal sevofluorane along the whole period of anesthesia for each arm/group.
Prediction probability (PK) is a statistical measure that is particularly suited to assess the performance of anesthetic depth indicators. It quantifies the correlation between observed anesthetic depth and indicator values. PK allows a simple interpretation and, as a non parametric measure, it is independent from scale units and assumptions on underlying distributions."|Entropy values from the induction moment to the awakening moment, 1/5 sec sampling rate, an average of 1 hours|||units on a scale||95% Confidence Interval|Number
643365|NCT02239679|Other Pre-specified|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|36 Weeks after PDT #1|Analysis population consisted of observed data only||Participants|||Count of Participants
643329|NCT02240368|Primary|BISPECTRAL Index|"The collected values of bispectral index and end tidal sevofluorane will generate a single prediction probability (PK) of agreement between bispectral index vs end-tidal sevofluorane along the whole period of anesthesia for each arm/group.
Prediction probability (PK) is a statistical measure that is particularly suited to assess the performance of anesthetic depth indicators. It quantifies the correlation between observed anesthetic depth and indicator values. PK allows a simple interpretation and, as a non parametric measure, it is independent from scale units and assumptions on underlying distributions."|BISPECTRAL index values from the induction moment to the awakening moment, 1/5 sec sampling rate, an average of 1 hours|||units on a scale||95% Confidence Interval|Number
643330|NCT02240329|Primary|Number of Coughs in Response to Stimulation With 200 Micro Moles Capsaicin in Solution|The total cough count (CTot) was determined by counting all cough events that occurred following each presentation of capsaicin solution. CTot was made, in real time, by two investigators and confirmed via review of the recorded cough airflow signal. Capsaicin concentration necessary to elicit a two cough threshold response (C2) within 30 seconds of presentation, on at least two (out of three) trials of that concentration, was identified from the cough count record. An average across all measurements was performed for the analysis.|Day 1|||cough events following stimulation||Standard Deviation|Mean
643331|NCT02240329|Primary|Average Urge to Cough (UTC) Following Administration of 200 Micro Mole Capsaicin Solution Concentration|Following 30 seconds of tidal breathing (to allow for acclimation to the facemask), participants were instructed to “take a sharp breath in” whereupon the nebulized capsaicin solution was automatically administered by the dosimeter. Following each aerosol presentation, the participant was instructed to rate their UTC using a modified Borg Rating Scale where 1 = no UTC and 10 = maximum UTC. Between presentations, participants were given a minimum of a one-minute rest period where they were offered water. An average across all measurements was performed for the analysis.|Day 1|||Units on a Borg scale||Standard Error|Mean
643332|NCT02239978|Secondary|Cortical Excitability|Investigators will assess the cortical excitability of the primary motor cortex in a subset of participants both ON and OFF levodopa. Specifically, we used transcranial magnetic stimulation to stimulate the motor cortex, where we measure muscular activity of the arm (i.e. motor evoked potentials; MEPs). The primary outcome variable noted below is the lowest stimulation setting (measured as a percentage) which results in an MEP in 5 of 10 trials.|TMS data was collected ON and OFF medication during one visit. This visit occurred within 3 weeks of the initial postural control assessments.|"As noted in our protocol, TMS was assessed in a subgroup of participants with PD. Seven of the 28 PD participants and 0 of the control group (healthy adults) were assessed. PD participants were assessed ON and OFF levodopa. We chose this approach because 1) this aim was exploratory in nature, and 2) MEPs of healthy adults are well characterized."||% max stim output||Standard Deviation|Mean
643333|NCT02239978|Secondary|Change in First Step Length|Investigators will assess (via automated and custom Matlab software) the length of the first step after a postural perturbation is delivered via motion of the support surface. This will be measured throughout the intervention, as well as at follow up (24 hour later).|Baseline and follow up (24 hours later) both ON and OFF antiparkinson medication|||meters||Standard Deviation|Mean
643334|NCT02239978|Primary|Change in Steps After Postural Perturbation|Investigators will assess (via automated and custom Matlab software) the number of steps taken after a postural perturbation is delivered via motion of the support surface. This will be measured throughout the intervention, as well as at follow up (24 hour later).|Baseline and follow up (24 hours later) both ON and OFF antiparkinson medication|"We were unable to collect reliable data on some of the people with PD while OFF medication, which is why there is a discrepancy between the Parkinson's disease and Parkinson's disease Off Medication arms."||Number of steps||Standard Deviation|Mean
643335|NCT02239978|Primary|Change in Movement of Center of Mass (COM) After Postural Perturbation|Investigators will assess (via automated and custom Matlab software) the magnitude of COM movement after a postural perturbation is delivered via motion of the support surface. This will be measured throughout the intervention, as well as at follow up (24 hour later).|Baseline and follow up (24 hours later) both ON and OFF antiparkinson medication|"We were unable to collect reliable data on some of the people with PD while OFF medication, which is why there is a discrepancy between the Parkinson's disease and Parkinson's disease Off Medication arms."||meters||Standard Deviation|Mean
643336|NCT02239926|Secondary|Mean Abdominal Pain|Daily abdominal pain intensity was rated using an 11-point (0-10) numeric rating scale, with 0 being no pain, and 10 being the worst pain imaginable. Participants were asked to rate their worst abdominal pain over the past 24 hours.|baseline to 4 weeks|The one subject who completed the study did not have complete data, so no analysis was performed. Study was terminated due to difficulty with enrollment.|||||
643337|NCT02239926|Primary|Change From Baseline in Diarrhea Using the Bowel Symptom Score (BSS).|BSS is a 100-mm visual analog scale for each symptom of Irritable Bowel Syndrome (IBS) (pain or discomfort, bloating, and diarrhea) with an overall severity score. Lower scores indicate symptoms are not present and higher scores indicate severe symptoms.|baseline to 4 weeks|The one subject who completed the study did not have complete data, so no analysis was performed. Study was terminated due to difficulty with enrollment.|||||
643338|NCT02239744|Secondary|Fractional Exhaled Nitric Oxide|FeNO is an established biomarker of respiratory inflammation, and has been widely used in epidemiological studies because of its high sensitivity, specificity and non-invasive nature. We measured FeNO levels using a portable NIOX MINO machine (Aerocrine AB, Solna, Sweden) according to standardized procedures by the American Thoracic Society and the European Respiratory Society.|within 1 hour after the two-day intervention|||ppb||Standard Deviation|Geometric Mean
643339|NCT02239744|Primary|Lung Function|A respiratory physician measured forced vital capacity, forced expiratory volume in 1 second and peak expiratory flow of each participant using the JAEGER Masterlab equipment (Würzburg, Germany) that meets the American Thoracic Society criteria. The volume signal was calibrated at least once on a testing day with a 3.0 L syringe connected to the pneumotachograph in accordance with the manufacturers’ recommendations. We instructed participants to perform at least three forced expiratory lung function maneuvers in order to obtain a minimum of two acceptable and reproducible values, and we recorded the best results.|Within 1 hour after the end of the two-day intervention|Ultimately, all 35 participants completed this study.This crossover study autonomically allows each subject to serve as his or her own control over time.||L||Standard Deviation|Geometric Mean
643340|NCT02239744|Secondary|Blood Pressure|After sitting in a quiet room for at least 5 min, participants had their left upper arm BP measured by trained technicians using a mercury sphygmomanometer at least three times with 2-min minimum intervals between measurements. The second and third sets of readings were averaged to obtain systolic BP and diastolic BP. Pulse pressure was calculated as the difference between systolic BP and diastolic BP. If the differences among the three measurements were bigger than 5 mmHg, a new round of measurements were arranged.|Within one hour after the 2-day intervention|||mmHg||Standard Deviation|Geometric Mean
643341|NCT02239744|Primary|Circulating Biomarkers|Peripheral blood samples (5 ml) were drawn by a nurse, separated into serum and plasma, and stored at -80 ℃ within 30 minutes. We measured the levels of 14 circulating biomarkers: (1) 8 biomarkers of inflammation, including C-reactive protein (CRP), fibrinogen, P-selection, monocyte chemoattractant protein-1 (MCP-1), interleukin-1b, interleukin-6, tumor necrosis factor-α (TNF-α) and myeloperoxidase; (2) 4 biomarkers of coagulation, including soluble CD40 ligand (sCD40L), plasminogen activator inhibitor-1, tissue plasminogen activator and D-Dimer; and (3) 2 biomarkers of vasoconstriction, including endothelin-1 and angiotensin-converting enzyme.|Blood samples were drawn within one hour after the intervention, and lab analysis was completed in the next 10 days|||ng/ml||Standard Deviation|Geometric Mean
643342|NCT02239692|Secondary|Clinically Significant Changes in Laboratory Values (Haematology, Clinical Chemistry, Coagulation and Urinalysis)|Laboratory parameters included routine haematology, clinical chemistry, coagulation and urinalysis. With the exception of urinalysis and urine pregnancy test, which was performed as dip-stick analyses at the trial site, all laboratory tests were analysed by a central laboratory.|From baseline (screening) up to day 10 after colonoscopy (inclusive of assessment at each visit)|The Safety analysis set consisted of all treated subjects and was analyzed according to the actual treatment received.||subjects|||Number
643343|NCT02239692|Secondary|Clinically Significant Changes in Vital Signs (Pulse and Blood Pressure)|Mean change from baseline to the end-of-trial was observed for pulse and blood pressure (systolic and diastolic).|From baseline (screening) up to day 10 after colonoscopy (inclusive of assessment at each visit)|The Safety analysis set consisted of all treated subjects and was analyzed according to the actual treatment received.||subjects|||Number
643344|NCT02239692|Secondary|Frequency and Intensity of Adverse Events||From baseline (screening) up to day 10 after colonoscopy|The Safety analysis set consisted of all treated subjects and was analyzed according to the actual treatment received.||subjects|||Number
643345|NCT02239692|Secondary|Ascending Colon Cleansing Responder Status (ITT)|Percentage of subjects classified as responders, i.e. Ottawa Scale score of either 0 (excellent) or 1 (good), during colonoscopy performed by a colonoscopist blinded to the dosing schedules.|Day 1 (day of colonoscopy)|The ITT analysis set consisted of all randomized subjects.||percentage of subjects|||Number
643346|NCT02239692|Primary|Overall Colon Cleansing Procedure (PP) Measured by the Total Ottawa Scale|Measured by the total Ottawa Scale score during the colonoscopy which is performed by a colonoscopist blinded to the dosing schedules. Total Ottawa Scale score was computed by adding the ratings (0 to 4; 0=excellent, 1=good, 2=fair, 3=poor, 4=inadequate) for each of the three colon segments and the overall fluid quality rating (0 to 2). The final score ranged from 0 (excellent) to 14 (solid stool in each colon segment and lots of fluid).|Day 1 (day of colonoscopy)|The per-protocol (PP) analysis set consisted of all the subjects included in ITT analysis set, but excluding subjects with major protocol deviations (18 subjects) that would impact efficacy analysis.||score on a scale||Standard Deviation|Mean
643347|NCT02239692|Primary|Overall Colon Cleansing Procedure (ITT) Measured by the Total Ottawa Scale|Measured by the total Ottawa Scale score during the colonoscopy performed by a colonoscopist blinded to the dosing schedules. Total Ottawa Scale score was computed by adding the ratings (0 to 4; 0=excellent, 1=good, 2=fair, 3=poor, 4=inadequate) for each of the three colon segments and the overall fluid quality rating (0 to 2). The final score ranged from 0 (excellent) to 14 (solid stool in each colon segment and lots of fluid).|Day 1 (day of colonoscopy)|The ITT analysis set consisted of all randomized subjects.||score on a scale||Standard Deviation|Mean
643348|NCT02239679|Other Pre-specified|Oozing/Vesiculation/Crusting|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|52 Weeks after PDT #1|Analysis population consisted of observed data only||Participants|||Count of Participants
643349|NCT02239679|Other Pre-specified|Oozing/Vesiculation/Crusting|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|36 Weeks after PDT #1|Analysis population consisted of observed data only||Participants|||Count of Participants
643350|NCT02239679|Other Pre-specified|Oozing/Vesiculation/Crusting|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|24 Weeks after PDT #1|Analysis population consisted of observed data only||Participants|||Count of Participants
643351|NCT02239679|Other Pre-specified|Oozing/Vesiculation/Crusting|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|12 Weeks after PDT #1|Analysis population consisted of observed data only||Participants|||Count of Participants
643352|NCT02239679|Other Pre-specified|Oozing/Vesiculation/Crusting|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|4 Weeks after PDT #1|Analysis population consisted of observed data only||Participants|||Count of Participants
643353|NCT02239679|Other Pre-specified|Oozing/Vesiculation/Crusting|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|24-48 hours after PDT #1|Analysis population consisted of observed data only||Participants|||Count of Participants
643354|NCT02239679|Other Pre-specified|Oozing/Vesiculation/Crusting|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|Baseline|||Participants|||Count of Participants
643355|NCT02239679|Other Pre-specified|Oozing/Vesiculation/Crusting|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|Screening|||Participants|||Count of Participants
643356|NCT02239679|Other Pre-specified|Scaling & Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|52 Weeks after PDT #1|Analysis population consisted of observed data only||Participants|||Count of Participants
643357|NCT02239679|Other Pre-specified|Scaling & Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|36 Weeks after PDT #1|Analysis population consisted of observed data only||Participants|||Count of Participants
643358|NCT02239679|Other Pre-specified|Scaling & Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|24 Weeks after PDT #1|Analysis population consisted of observed data only||Participants|||Count of Participants
643359|NCT02239679|Other Pre-specified|Scaling & Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|12 Weeks after PDT #1|Analysis population consisted of observed data only||Participants|||Count of Participants
643360|NCT02239679|Other Pre-specified|Scaling & Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|4 Weeks after PDT #1|Analysis population consisted of observed data only||Participants|||Count of Participants
643361|NCT02239679|Other Pre-specified|Scaling & Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|24-48 hours after PDT #1|Analysis population consisted of observed data only||Participants|||Count of Participants
643362|NCT02239679|Other Pre-specified|Scaling & Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Baseline|||Participants|||Count of Participants
643363|NCT02239679|Other Pre-specified|Scaling & Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Screening|||Participants|||Count of Participants
646149|NCT02153489|Other Pre-specified|Change From Baseline in Duration of at Least Moderate Activity|Moderate activity was defined as any physical activity >3 metabolic equivalents|Week 3 of treatment|||Minutes||Standard Error|Least Squares Mean
643366|NCT02239679|Other Pre-specified|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|24 Weeks after PDT #1|Analysis population consisted of observed data only||Participants|||Count of Participants
643367|NCT02239679|Other Pre-specified|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|12 Weeks after PDT #1|Analysis population consisted of observed data only||Participants|||Count of Participants
643368|NCT02239679|Other Pre-specified|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|4 Weeks after PDT #1|Analysis population consisted of observed data only||Participants|||Count of Participants
643369|NCT02239679|Other Pre-specified|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|24-48 hours after PDT #1|Analysis population consisted of observed data only||Participants|||Count of Participants
643370|NCT02239679|Other Pre-specified|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|5 minutes after PDT #1|||Participants|||Count of Participants
643371|NCT02239679|Other Pre-specified|Stinging/Burning|"﻿Immediately after PDT, the most intensive, acute perception of Stinging/Burning DURING treatment will be recorded.
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable"|During PDT #1|||Participants|||Count of Participants
643372|NCT02239679|Other Pre-specified|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|Baseline|||Participants|||Count of Participants
643373|NCT02239679|Other Pre-specified|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|Screening|||Participants|||Count of Participants
643374|NCT02239679|Other Pre-specified|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|52 Weeks after PDT #1|Analysis population consisted of observed data only||Participants|||Count of Participants
643375|NCT02239679|Other Pre-specified|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|36 Weeks after PDT #1|Analysis population consisted of observed data only||Participants|||Count of Participants
643376|NCT02239679|Other Pre-specified|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|24 weeks after PDT #1|Analysis population consisted of observed data only||Participants|||Count of Participants
643377|NCT02239679|Other Pre-specified|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|12 Weeks after PDT #1|Analysis population consisted of observed data only||Participants|||Count of Participants
643378|NCT02239679|Other Pre-specified|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|4 Weeks after PDT #1|Analysis population consisted of observed data only||Participants|||Count of Participants
643379|NCT02239679|Other Pre-specified|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|24-48 hours after PDT #1|Analysis population consisted of observed data only||Participants|||Count of Participants
643380|NCT02239679|Other Pre-specified|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|5 minutes after PDT #1|||Participants|||Count of Participants
643381|NCT02239679|Other Pre-specified|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Baseline|||Participants|||Count of Participants
643433|NCT02238782|Primary|Absolute Bioavailability|To calculate absolute bioavailability we used the formula: Area Under the Curve (oral dose)/Area Under the Curve (intravenous dose)*100|0 to 72 hours post-dose|||% of bioavailability||90% Confidence Interval|Geometric Mean
643382|NCT02239679|Other Pre-specified|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Screening|||Participants|||Count of Participants
643383|NCT02239679|Other Pre-specified|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|52 Weeks after PDT #1|Analysis population consisted of observed data only||Participants|||Count of Participants
643384|NCT02239679|Other Pre-specified|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|36 Weeks after PDT #1|Analysis population consisted of observed data only||Participants|||Count of Participants
643385|NCT02239679|Other Pre-specified|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|24 Weeks after PDT #1|Analysis population consisted of observed data only||Participants|||Count of Participants
643386|NCT02239679|Other Pre-specified|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|12 Weeks after PDT #1|Analysis population consisted of observed data only||Participants|||Count of Participants
643387|NCT02239679|Other Pre-specified|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|4 Weeks after PDT #1|Analysis population consisted of observed data only||Participants|||Count of Participants
643388|NCT02239679|Other Pre-specified|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|24-48 hours after PDT #1|Analysis population consisted of observed data only||Participants|||Count of Participants
643389|NCT02239679|Other Pre-specified|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|5 minutes after PDT #1|||Participants|||Count of Participants
643390|NCT02239679|Other Pre-specified|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Baseline|||Participants|||Count of Participants
643391|NCT02239679|Other Pre-specified|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Screening|||Participants|||Count of Participants
643392|NCT02239679|Other Pre-specified|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation|52 Weeks after PDT #1|Analysis population consisted of observed data only||Participants|||Count of Participants
643393|NCT02239679|Other Pre-specified|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation|36 Weeks after PDT #1|Analysis population consisted of observed data only||Participants|||Count of Participants
646150|NCT02153489|Other Pre-specified|Change From Baseline in Total Sleep Time||Week 3 of treatment|||Minutes||Standard Error|Least Squares Mean
643394|NCT02239679|Other Pre-specified|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation|24 Weeks after PDT #1|Analysis population consisted of observed data only||Participants|||Count of Participants
643395|NCT02239679|Other Pre-specified|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation|12 Weeks after PDT #1|Analysis population consisted of observed data only||Participants|||Count of Participants
643396|NCT02239679|Other Pre-specified|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation|4 Weeks after PDT #1|Analysis population consisted of observed data only||Participants|||Count of Participants
643397|NCT02239679|Other Pre-specified|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation|24-48 hours after PDT #1|Analysis population consisted of observed data only||Participants|||Count of Participants
643398|NCT02239679|Other Pre-specified|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation|Baseline|||Participants|||Count of Participants
643399|NCT02239679|Other Pre-specified|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation|Screening|||Participants|||Count of Participants
643400|NCT02239679|Other Pre-specified|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|52 Weeks after PDT #1|Analysis population consisted of observed data only||Participants|||Count of Participants
643401|NCT02239679|Other Pre-specified|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|36 Weeks after PDT #1|Analysis population consisted of observed data only||Participants|||Count of Participants
643402|NCT02239679|Other Pre-specified|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|24 Weeks after PDT #1|Analysis population consisted of observed data only||Participants|||Count of Participants
643403|NCT02239679|Other Pre-specified|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|12 Weeks after PDT #1|Analysis population consisted of observed data only||Participants|||Count of Participants
643404|NCT02239679|Other Pre-specified|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|4 Weeks after PDT #1|Analysis population consisted of observed data only||Participants|||Count of Participants
643405|NCT02239679|Other Pre-specified|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|24-48 hours after photodynamic therapy (PDT) #1|Analysis population consisted of observed data only||Participants|||Count of Participants
643406|NCT02239679|Other Pre-specified|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Baseline|||Participants|||Count of Participants
643733|NCT02229864|Secondary|Number of Subjects With Target Lesion Failure (Cardiac Death, TVMI, TLR)|Target Lesion Failure (TLF) includes Cardiac Death, Target vessel - myocardial infarction and Target Lesion Revascularization (TLR).|0 to 208 Days|||Participants|||Count of Participants
643407|NCT02239679|Other Pre-specified|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Screening|||Participants|||Count of Participants
643408|NCT02239679|Secondary|Duration of Response|Duration of response is the elapsed number of weeks from the Baseline visit until a lesion recurred or Week 52, whichever comes first|within 52 weeks after Baseline|Subjects who discontinued prior to Week 52 were excluded; analysis used observed data only.||weeks||Standard Deviation|Mean
643409|NCT02239679|Secondary|Recurrence Rate|Recurrence rate of all lesions that were complete responses following on-study cryotherapy (at Visit 3/Baseline).|Week 52|Analysis population consisted of observed data only||number of lesions|number of lesions||Count of Units
643410|NCT02239679|Secondary|Proportion of Subjects With 0 AKs|Normalized based on number of lesions present at Baseline|Week 52|Analysis population consisted of observed data only||Participants|||Count of Participants
643411|NCT02239679|Secondary|Proportion of Subjects With 0 AKs|Normalized based on number of lesions present at Baseline|Week 36|Analysis population consisted of observed data only||Participants|||Count of Participants
643412|NCT02239679|Secondary|Proportion of Subjects With 0 AKs|Normalized based on number of lesions present at Baseline|Week 24|Analysis population consisted of observed data only.||Participants|||Count of Participants
643413|NCT02239679|Secondary|Proportion of Subjects With 0 AKs|Normalized based on number of lesions present at Baseline|Week 12|Analysis population consisted of observed data; ie. subjects with data at Week 12.||Participants|||Count of Participants
643414|NCT02239679|Secondary|Subject Satisfaction Score|"Subject satisfaction score
= Excellent (very satisfied)
= Good (moderately satisfied)
= Fair (slightly satisfied)
= Poor (not satisfied at all) Unknown"|Week 52|||Participants|||Count of Participants
643415|NCT02239679|Secondary|Proportion of Subjects With 0 AKs|Normalized based on number of lesions present at Baseline|Week 4|Analysis population consisted of observed data; ie. subjects with data at Week 4.||Participants|||Count of Participants
643416|NCT02239679|Primary|Total Number of AKs in Treatment Area|Count of observed lesions in the treatment area, which include lesions that recurred after on-study cryotherapy as well as newly occurring lesions. AK lesions in the treatment area at baseline (maximum of 2) were excluded for this endpoint.|Week 52|Analysis population consisted of observed data; ie. subjects remaining on-study at Week 52.||lesions||Standard Error|Least Squares Mean
643417|NCT02239289|Secondary|Lumbo-pelvic Range of Motion During Trunk Flexion-extension|Range of motion is recorder throught 8 kinematic markers placed on the right lower limb and the back of each participant during every trials of each session.|Week 4|||Degrees||Standard Deviation|Mean
643418|NCT02239289|Secondary|Lumbo-pelvic Range of Motion During Trunk Flexion-extension|Range of motion is recorder throught 8 kinematic markers placed on the right lower limb and the back of each participant during every trials of each session.|Week 3|||Degrees||Standard Deviation|Mean
643419|NCT02239289|Secondary|Lumbo-pelvic Range of Motion During Trunk Flexion-extension|Range of motion is recorder throught 8 kinematic markers placed on the right lower limb and the back of each participant during every trials of each session.|Week 2|||Degrees||Standard Deviation|Mean
643420|NCT02239289|Secondary|Pain Intensity in the Past Week|101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).|Week 4|||Units on a scale||Full Range|Mean
643421|NCT02239289|Secondary|Pain Intensity in the Past Week|101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).|Week 3|||Units on a scale||Full Range|Mean
643422|NCT02239289|Secondary|Current Pain Intensity|101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).|Week 4|||Units on a scale||Full Range|Mean
643423|NCT02239289|Secondary|Current Pain Intensity|101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).|Week 2|||Units on a scale||Full Range|Mean
643424|NCT02239289|Secondary|Fear of Movement Level|Tampa scale for kinesiophobia ranges from 0 to 68. Higher score indicates higher fear of movement level.|Week 4|||units on a scale||Full Range|Mean
643425|NCT02239289|Secondary|Current Pain Intensity|101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).|Week 3|||Units on a scale||Full Range|Mean
643426|NCT02239289|Secondary|Pain Intensity in the Past Week|101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).|Week 2|||Units on a scale||Full Range|Mean
643427|NCT02239289|Secondary|Disability Level|Oswestry disability index ranges from 0 to 100. A higher score indicates higher disability.|Week 4|||units on a scale||Full Range|Mean
643428|NCT02239289|Secondary|Lumbo-pelvic Range of Motion During Trunk Flexion-extension|Range of motion is recorder throught 8 kinematic markers placed on the right lower limb and the back of each participant during every trials of each session.|Week 1|||Degrees||Standard Deviation|Mean
643429|NCT02239289|Primary|Flexion-relaxation Ratio|Flexion-relaxation ratio is calculated by dividing muscle activity (EMG) during trunk flexion by muscle activity during full-flexed position. EMG of lumbar paraspinal muscles is recorder through surface EMG during every trials of each session.|Week 4|||ratio||Standard Deviation|Mean
643430|NCT02239289|Primary|Flexion-relaxation Ratio|Flexion-relaxation ratio is calculated by dividing muscle activity (EMG) during trunk flexion by muscle activity during full-flexed position. EMG of lumbar paraspinal muscles is recorder through surface EMG during every trials of each session.|Week 3|||ratio||Standard Deviation|Mean
643431|NCT02239289|Primary|Flexion-relaxation Ratio|Flexion-relaxation ratio is calculated by dividing muscle activity (EMG) during trunk flexion by muscle activity during full-flexed position. EMG of lumbar paraspinal muscles is recorder through surface EMG during every trials of each session.|Week 2|||ratio||Standard Deviation|Mean
643432|NCT02239289|Primary|Flexion-relaxation Ratio|Flexion-relaxation ratio is calculated by dividing muscle activity (EMG) during trunk flexion by muscle activity during full-flexed position. EMG of lumbar paraspinal muscles is recorder through surface EMG during every trials of each session.|Week 1|||Ratio||Standard Deviation|Mean
643757|NCT02229513|Secondary|Bakri Bulb Placement||Intraoperatively|||participants|||Number
643758|NCT02229513|Secondary|Use of Cytotec||Intraoperatively|||participants|||Number
643434|NCT02238379|Secondary|Number of Participants Testing Positive for Alcohol Use Following a Breathalyzer|Participants will complete an alcohol breathalyzer to characterize the alcohol use status of the sample.|Within 30 minutes of study visit commencing|1 participant lost to follow-up; data indicates number of participants with alcohol in their system||Participants|||Count of Participants
643435|NCT02238379|Secondary|Number of Participants Endorsing Substance Use|The investigators will employ the ASI Lite (McLellan, Luborsky, Woody, & O'Brien, 1980) to assess for current substance use. This measure is included to characterize the sample in respect of substance use; however the ASI Lite did not provide a measure of substance dependance and therefore we report the data from the Mini International Neuropsychiatric Interview substance dependance module (Sheehan et al., 1998) to provide a specific indication of the presence of absence of substance dependance.|Within 30 minutes of study visit commencing|1 participant lost to follow-up; count of participants where substance dependence indicated||Participants|||Count of Participants
643436|NCT02238379|Secondary|Early Experience|"The investigators will employ the Parental Bonding Instrument (Parker, Tupling, & Brown, 1979) to assess the early relationship experiences participants have with their caregivers. Existing research employing intranasal oxytocin suggests that the quality of early relationships may impact the strength of any modulation of brain or behavior by oxytocin administration and therefore this variable will be included in the analyses in support of this hypothesis. There are 12 items that capture parental care and 13 items that capture parental overprotection. Items are scored on a 4-point likert scale from very like to very unlike. The PBI is typically scored by identifying optimal (High Care Scores, Low Protection Scores) and less optimal (Low Care Scores, Low Protection Scores) scores on the mother and father subscales (NB: protection refers to overprotection). For the care items, scores can range from 0 to 36; for overprotection items, scores can range from 0 to 39."|Within 20 minutes of study visit commencing|Only participants included that have ERP data to analyze (excluding participant lost to follow-up and data loss); 1 participant did not know their father and did not complete the measure for paternal assessment||units on a scale||Standard Deviation|Mean
643437|NCT02238379|Secondary|Stress|The investigators will measure current levels of stress by using the Perceived Stress Scale (Cohen et al., 1983). It is not yet known the extent to which variation in perceived stress is associated with this methodology, but it is anticipated stress will be associated with levels of depression and anxiety in the sample. The PSS consists of 14 items, with scores ranging from 0 to 42, with higher scores indicating higher levels of perceived stress. A score of 21+ is considered to indicate that participants have higher than average stress.|Within 20 minutes of study visit commencing|Only participants included that have ERP data to analyze (excluding participant lost to follow-up and data loss)||units on a scale||Standard Deviation|Mean
643438|NCT02238379|Secondary|Anxiety|The investigators will assess anxiety using the State-Trait Anxiety Inventory (Spielberger et al., 1970). Specifically, it will be explored whether participant anxiety symptoms are associated with the neural correlates of social and non-social perception during both intervention and placebo visits. It is not yet known the extent to which variation in anxiety symptoms are associated with this methodology, although prior research has suggested anxiety modulates the neural response to social cues. Scores range from 20-80 and a higher score on both state and trait measures indicate higher levels of anxiety. A potential clinical cut off has been proposed for participants scoring over 39-40 as being high anxious.|Within 20 minutes of study visit commencing|Only participants included that have ERP data to analyze (excluding participant lost to follow-up and data loss)||units on a scale||Standard Deviation|Mean
643439|NCT02238379|Secondary|Smoking|Participants will complete a CO breathalyzer and the Fagerstrom Test for Nicotine Dependence (Heatherton, Kozlowski, Frecker, & Fagerstrom, 1991) to assess smoking behavior. These measures are included to characterize the sample in respect of substance use.|Within 30 minutes of study visit commencing|1 participant was lost to follow-up||Participants|||Count of Participants
643440|NCT02238379|Secondary|Depression|The investigators will assess depression by employing the Beck Depression Inventory (Beck et al., 1961). Specifically addressing whether the level of depression symptomatology in participants and whether this is associated with the neural correlates of social and non-social perception during both intervention and placebo visits. It is not yet known the extent to which variation in depression symptoms are associated with this methodology, although prior research has suggested depression modulates the neural response to social cues. This measure includes a question regarding suicidal ideation and therefore it is acknowledged there may be a safety issue in response to the questionnaire. Scores range from 0-63, with higher scores indicating greater levels of depression (scores 29+ indicates severe depression).|Within 20 minutes of study visit commencing|Only participants included that have ERP data to analyze (excluding participant lost to follow-up and data loss)||units on a scale||Standard Deviation|Mean
643441|NCT02238379|Primary|Latency Non-Social|The investigators will analyze the latency (i.e., efficiency of processing) of visually elicited ERP components to the non-social stimuli (houses). This assessment will be completed after administration of the intervention (oxytocin) and the placebo to compare the neural response. The investigators hypothesize that there will be no difference between the intervention and placebo on ERP latency measures in the non-social condition.|Duration of 30 minutes|1 participant was lost to follow-up (did not complete placebo); 1 participant's data was lost (removed then from placebo and oxytocin arms); 2 participants were statistical outliers and removed from oxytocin and placebo arms for N170 latency analysis||milliseconds||Standard Deviation|Mean
643442|NCT02238379|Primary|Latency Social|The investigators analyze the latency (i.e., efficiency of processing) of visually elicited ERP components to the social stimuli (infant and adult faces). This assessment will be completed after administration of the intervention (oxytocin) and the placebo to compare the neural response. The investigators hypothesize that there will be more efficient processing (i.e., earlier latency) of ERPs during the social condition following administration of the intervention relative to the placebo condition.|Duration of 30 minutes|1 participant was lost to follow-up (did not complete placebo); 1 participant's data was lost (removed then from placebo and oxytocin arms); for LPP analysis, 1 participants were statistical outliers and removed from oxytocin and placebo arms for N170 latency analysis||milliseconds||Standard Deviation|Mean
643510|NCT02235454|Primary|Retinal Nerve Fiber Layer (RNFL) Thickness Correlation Width Global Bruch's Membrane Opening-minimum Rim Width (BMO-MRW)|Pearson correlation coefficient between Retinal Nerve Fiber Layer (RNFL) thickness correlation width global Bruch's membrane opening-minimum rim width (BMO-MRW).|imaging approximately 10 minutes|All usable images of one eye of each participant||correlation coefficient|||Number
643443|NCT02238379|Primary|Amplitude Non-Social|The investigators analyze the amplitude (i.e., size) of visually elicited event-related potential (ERP) components to the non-social stimuli (houses). This assessment will be completed after administration of the intervention (oxytocin) and the placebo to compare the neural response. The investigators hypothesize that there will be no difference between the intervention and placebo during the non-social condition on the amplitude of the ERPs.|Duration of 30 minutes|1 participant was lost to follow-up (did not complete placebo); 1 participant's data was lost (removed then from placebo and oxytocin arms)||microvolts||Standard Deviation|Mean
643444|NCT02238379|Primary|Amplitude Social|The investigators will analyze the amplitude (i.e., size) of visually elicited event-related potential (ERP) components to the social stimuli (infant and adult faces). This assessment will be completed after administration of the intervention (oxytocin) and the placebo to compare the neural response. The investigators hypothesize that the intervention will modulate the amplitude of the neural response to social stimuli given its previously identified role in social interactions, most likely increasing the size of the ERPs.|Duration of 30 minutes|1 participant was lost to follow-up (did not complete placebo); 1 participant's data was lost (removed then from placebo and oxytocin arms); for LPP analysis, 1 participant was a statistical outlier and removed from oxytocin and placebo arms||microvolts||Standard Deviation|Mean
643445|NCT02238080|Secondary|Serum Hemoglobin Level||Baseline, Month 6|ITT population. 'Number analyzed' included participants evaluable for individual categories.||grams per deciliter (g/dL)||Standard Deviation|Mean
643446|NCT02238080|Secondary|Predictive Baseline Serum IL-6 Level for Participants Initiating Treatment With Methoxy Polyethylene Glycol-Epoetin Beta Dose||Day 1|As per change in planned analysis, this outcome was removed due to small sample size and no data was collected for this outcome.|||||
643447|NCT02238080|Secondary|Predictive Baseline Serum CRP Level for Participants Initiating Treatment With Methoxy Polyethylene Glycol-Epoetin Beta Dose||Day 1|As per change in planned analysis, this outcome was removed due to small sample size and no data was collected for this outcome.|||||
643448|NCT02238080|Secondary|Correlation Coefficient (r) Between Serum IL-6 Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6|Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r).|Month 6|ITT population. Participants with stable maintenance treatment were included in this analysis. ‘Number of participants analyzed’ (N) included participants evaluable for this outcome measure.||correlation coefficient|||Number
643449|NCT02238080|Secondary|Correlation Coefficient (r) Between Serum CRP Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6|Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r).|Month 6|ITT population. Participants with stable maintenance treatment were included in this analysis. ‘Number of participants analyzed’ (N) included participants evaluable for this outcome measure.||correlation coefficient|||Number
643450|NCT02238080|Secondary|Serum IL-6 Level||Baseline, Month 6|ITT population. Participants with stable maintenance treatment were included in this analysis. 'Number analyzed' included participants evaluable for individual categories.||picograms per milliliter (pg/mL)||Standard Deviation|Mean
643451|NCT02238080|Secondary|Serum CRP Level||Baseline, Month 6|ITT population. Participants with stable maintenance treatment were included in this analysis. 'Number analyzed' included participants evaluable for individual categories.||milligrams per liter (mg/L)||Standard Deviation|Mean
643452|NCT02238080|Secondary|Change From Baseline in Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6||Baseline, Month 6|ITT population. Participants with stable maintenance treatment were included in this analysis. ‘Number of participants analyzed’ (N) included participants evaluable for this outcome measure. 'Number analyzed' included participants evaluable for individual categories.||mcg/kg||Standard Deviation|Mean
643453|NCT02238080|Secondary|Percentage of Participants With Change in Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6|Percentage of participants with change in methoxy polyethylene glycol-epoetin beta dose compared to baseline were reported as per the following categories: (a) No change, (b) Dose increase (1 to greater than [>] 200 micrograms per kilogram [mcg/kg]), and (c) Dose decrease (1 to >200 mcg/kg).|Month 6|ITT population. Participants with stable maintenance treatment were included in this analysis.||percentage of participants|||Number
643454|NCT02238080|Primary|Correlation Coefficient (r) Between Serum Interleukin-6 (IL-6) Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose|Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r).|Day 1|ITT population. Participants with stable maintenance treatment were included in this analysis. ‘Number of participants analyzed’ (N) included participants evaluable for this outcome measure.||correlation coefficient|||Number
643455|NCT02238080|Primary|Correlation Coefficient (r) Between Serum C-Reactive Protein (CRP) Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose|Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r).|Day 1|ITT population. Participants with stable maintenance treatment were included in this analysis. ‘Number of participants analyzed’ (N) included participants evaluable for this outcome measure.||correlation coefficient|||Number
643456|NCT02238067|Secondary|Percentage of Participants by Injection Site Pain by ESA Type|Assessment was performed by physician via a satisfaction survey on anemia treatment. Participants were asked for the type of ESA received (Mircera, Recormon, Eprex or Aranesp) and to rate their injection site pain on a 1-5 scale, where 1 represents 'Not painful' and 5 represents 'Very painful'. Percentage of participants with each score and ESA type was reported.|Baseline, Month 6|All enrolled participants. Here ‘n’ signifies number of participants evaluable for specified categories.||percentage of participants|||Number
643457|NCT02238067|Secondary|Percentage of Participants by Injection Site Pain|Assessment was performed by physician via a satisfaction survey on anemia treatment. Participants were asked to rate their injection site pain on a 1-5 scale, where 1 represents 'Not painful' and 5 represents 'Very painful'. Percentage of participants with each score was reported.|Baseline, Month 6|All enrolled participants. Here ‘n’ signifies number of participants evaluable at specified time-points.||percentage of participants||95% Confidence Interval|Number
643511|NCT02235311|Secondary|Community-Acquired Pneumonia|As defined by clinical suspicion and/or positive sputum culture requiring antibiotic treatment|8 weeks|||Participants|||Count of Participants
643512|NCT02235311|Secondary|Clostridium Difficile Diarrhea|Clostridium difficile confirmed by polymerase chain reaction (PCR)|8 weeks|||Participants|||Count of Participants
643759|NCT02229513|Secondary|Use of Hemabate||Intraoperatively|||participants|||Number
643458|NCT02238067|Secondary|Percentage of Participants by Convenience of Syringe Usage by ESA Type|Assessment was performed by physician via a satisfaction survey on anemia treatment. Participants were asked for the type of ESA received (Mircera, Recormon, Eprex or Aranesp) and to rate their convenience of syringe usage on a 1-5 scale, where 1 represents 'Inconvenient' and 5 represents 'Very convenient'. Percentage of participants with each score and ESA type was reported.|Baseline, Month 6|All enrolled participants. Here ‘n’ signifies number of participants evaluable for specified categories.||percentage of participants|||Number
643459|NCT02238067|Secondary|Percentage of Participants by Convenience of Syringe Usage|Assessment was performed by physician via a satisfaction survey on anemia treatment. Participants were asked to rate their convenience of syringe usage on a 1-5 scale, where 1 represents 'Inconvenient' and 5 represents 'Very convenient'. Percentage of participants with each score was reported.|Baseline, Month 6|All enrolled participants. Here ‘n’ signifies number of participants evaluable at specified time-points.||percentage of participants||95% Confidence Interval|Number
643460|NCT02238067|Secondary|Percentage of Participants by Limitation of Daily Life Due to ESA Refrigeration Requirements by ESA Types|Assessment was performed by physician via a satisfaction survey on anemia treatment. Participants were asked for the type of ESA received (Mircera, Recormon, Eprex or Aranesp) and to rate their limitation of daily life due to ESA refrigeration requirements on a 1-5 scale, where 1 represents 'Does not limit' and 5 represents 'significantly limits'. Percentage of participants with each score and ESA type was reported.|Baseline, Month 6|All enrolled participants. Here ‘n’ signifies number of participants evaluable for specified categories.||percentage of participants|||Number
643461|NCT02238067|Secondary|Percentage of Participants by Limitation of Daily Life Due to ESA Refrigeration Requirements|Assessment was performed by physician via a satisfaction survey on anemia treatment. Participants were asked to rate their limitation of daily life due to ESA refrigeration requirements on a 1-5 scale, where 1 represents 'Does not limit' and 5 represents 'significantly limits'. Percentage of participants with each score was reported.|Baseline, Month 6|All enrolled participants. Here ‘n’ signifies number of participants evaluable at specified time-points.||percentage of participants||95% Confidence Interval|Number
643462|NCT02238067|Secondary|Percentage of Participants by Preferred Treatment Frequency by Baseline ESA Frequency|"Assessment was performed by physician via a satisfaction survey on anemia treatment. Participants were asked for their preference of treatment frequency and baseline ESA frequency. Participants were asked Assuming that there are several options for anemia treatment with the only difference being the frequency of use, what is your preference?. Preferred treatment frequency included: once a month (O/M), twice a month (B/M), once a week (O/W), twice a week (B/W), three times a week (T/W) or other (any other frequency]). Frequency of baseline ESA use included: three times a week, twice a week, once a week, every 2 weeks (Q2W), every 4 weeks (Q4W) or other (any other frequency). Percentage of participants by each preferred treatment frequency and baseline ESA frequency was reported."|Baseline, Month 6|All enrolled participants. Number of participants analyzed = participants evaluable for this outcome measure. Here 'n' signifies number of participants evaluable for specified categories.||percentage of participants|||Number
643463|NCT02238067|Secondary|Percentage of Participants by Preferred Treatment Frequency by ESA Type|"Assessment was performed by physician via a satisfaction survey on anemia treatment. Participants were asked for the type of ESA received (Mircera, Recormon, Eprex or Aranesp) and their preference of treatment frequency. Participants were asked Assuming that there are several options for anemia treatment with the only difference being the frequency of use, what is your preference?. Participants answered as either once a month, twice a month, once a week, twice a week, three times a week or other (any other frequency). Percentage of participants with each preferred treatment frequency and ESA type was reported."|Baseline, Month 6|All enrolled participants. Here ‘n’ signifies number of participants evaluable for specified categories.||percentage of participants|||Number
643464|NCT02238067|Secondary|Percentage of Participants by Preferred Treatment Frequency|"Assessment was performed by physician via a satisfaction survey on anemia treatment. Participants were asked Assuming that there are several options for anemia treatment with the only difference being the frequency of use, what is your preference?. Participants answered as either once a month, twice a month, once a week, twice a week, three times a week or other (any other frequency). Percentage of participants with each preferred treatment frequency was reported."|Baseline, Month 6|All enrolled participants. Here ‘n’ signifies number of participants evaluable at specified time-points.||percentage of participants||95% Confidence Interval|Number
643465|NCT02238067|Secondary|Percentage of Participants by Need for Improvement in Treatment Frequency by ESA Type|Assessment was performed by physician via a satisfaction survey on anemia treatment. Participants were asked for the type of ESA received (Mircera, Recormon, Eprex or Aranesp) and to rate their need for improvement in the frequency of each treatment received currently on a 1-5 scale, where 1 represents 'Convenient, there is no need for improvement' and 5 represents 'improvement is very necessary'. Percentage of participants with each score and ESA type was reported.|Baseline, Month 6|All enrolled participants. Here ‘n’ signifies number of participants evaluable for specified categories.||percentage of participants|||Number
643466|NCT02238067|Secondary|Percentage of Participants by Need for Improvement in Treatment Frequency|Assessment was performed by physician via a satisfaction survey on anemia treatment. Participants were asked to rate their need for improvement in the frequency of treatment received currently on a 1-5 scale, where 1 represents 'Convenient, there is no need for improvement' and 5 represents 'Improvement is very necessary'. Percentage of participants with each score was reported.|Baseline, Month 6|All enrolled participants. Here ‘n’ signifies number of participants evaluable at specified time-points.||percentage of participants||95% Confidence Interval|Number
643467|NCT02238067|Secondary|Percentage of Participants With Interest in Learning to Inject Independently|Assessment was performed by physician via a satisfaction survey on anemia treatment. Participants responded 'yes' or 'no' to the question: 'Would you be interested in learning to inject independently?' ’ Percentage of participants who responded ‘yes’, was reported.|Baseline, Month 6|All enrolled participants who did not inject independently. Here ‘n’ signifies number of participants evaluable at specified time-points.||percentage of participants||95% Confidence Interval|Number
643513|NCT02235311|Secondary|Rate of Rebleed|"Per patient report or as defined by follow-up endoscopy per gastroenterology service, 8 weeks after UGIB acute management
High clinical suspicion of rebleed includes melena, hematochezia, confirmed by repeat endoscopy, requiring additional management"|8 weeks|||Participants|||Count of Participants
643468|NCT02238067|Secondary|Percentage of Participants by Different Injection Administration Modes|Assessment was performed by physician via a satisfaction survey on anemia treatment. Participants were asked: 'How do you currently inject the anemia treatment?' and reported any of the 5 possible answers: Independently, by a family member, nurse at home, nurse at the clinic or other. Percentage of participants with each injection administration modes was reported.|Baseline, Month 6|All enrolled participants. Here ‘n’ signifies number of participants evaluable at specified time-points.||percentage of participants|||Number
643469|NCT02238067|Secondary|Percentage of Participants by Different CKD Stages|Assessment was performed by physician via a satisfaction survey on anemia treatment. CKD stages were based on participant’s answer to the survey question. No specific method of assessment for CKD stage was specified. Percentage of participants with each CKD stage was reported.|Baseline, Month 6|All enrolled participants. Here ‘n’ signifies number of participants evaluable at specified time-points.||percentage of participants|||Number
643470|NCT02238067|Primary|Percentage of Participants by Frequency and Types of ESA Used at Month 6|Assessment was performed by physician via a satisfaction survey on anemia treatment. Frequency of ESA use included:Three times a week, twice a week, once a week, every 2 weeks, every 4 weeks or other (any other frequency). ESA types included: Mircera, Recormon, Eprex, and Aranesp. Percentage of participants with each ESA type and each frequency of ESA use was reported.|Month 6|All enrolled participants who completed the questionnaire at Month 6. Here 'n' signifies number of participants evaluable for specified categories.||percentage of participants|||Number
643471|NCT02238067|Primary|Percentage of Participants by Frequency and Types of ESA Used at Baseline|Assessment was performed by physician via a satisfaction survey on anemia treatment. Frequency of ESA use included:Three times a week, twice a week, once a week, every 2 weeks, every 4 weeks or other (any other frequency). ESA types included: Mircera, Recormon, Eprex, and Aranesp. Percentage of participants with each ESA type and each frequency of ESA use was reported.|Baseline|All enrolled participants. Number of participants analyzed = participants evaluable for this outcome measure. Here ‘n’ signifies number of participants evaluable for specified categories.||percentage of participants|||Number
643472|NCT02238067|Primary|Percentage of Participants by Frequency of ESA Use at Month 6|Assessment was performed by physician via a satisfaction survey on anemia treatment. Frequency of ESA use included:Three times a week, twice a week, once a week, every 2 weeks, every 4 weeks or other (any other frequency). Percentage of participants by each frequency of ESA use was reported.|Month 6|All enrolled participants who completed the questionnaire at Month 6||percentage of participants||95% Confidence Interval|Number
643473|NCT02238067|Primary|Percentage of Participants by Frequency of ESA Use at Baseline|Assessment was performed by physician via a satisfaction survey on anemia treatment. Frequency of ESA use included:Three times a week, twice a week, once a week, every 2 weeks, every 4 weeks or other (any other frequency). Percentage of participants by each frequency of ESA use was reported.|Baseline|All enrolled participants. Number of participants analyzed = participants evaluable for this outcome measure.||percentage of participants||95% Confidence Interval|Number
643474|NCT02238067|Primary|Percentage of Participants by ESA Types at Month 6|Assessment was performed by physician via a satisfaction survey on anemia treatment. ESA types included: Mircera, Recormon, Eprex, and Aranesp. Percentage of participants with each ESA type was reported.|Month 6|All enrolled participants who completed the questionnaire at Month 6||percentage of participants||95% Confidence Interval|Number
643475|NCT02238067|Primary|Percentage of Participants by ESA Types at Baseline|Assessment was performed by physician via a satisfaction survey on anemia treatment. ESA types included: Mircera, Recormon, Eprex, and Aranesp. Percentage of participants with each ESA type was reported.|Baseline|All enrolled participants||percentage of participants||95% Confidence Interval|Number
643476|NCT02238028|Primary|Circulating Biomarkers——ET-1|At the end of each intervention, participants were asked to rest in a quiet room for half an hour. Peripheral venous blood samples were collected and centrifuged immediately. The serum were collected and stored at -80℃ within 30 minutes to minimize the in-vitro changes in biomarker proteins. Endothelin-1(ET-1) was using enzyme-linked immunosorbent assays.|Up to 24 hours|||pg/ml||Standard Deviation|Geometric Mean
643477|NCT02238028|Primary|Circulating Biomarkers——P- Selectin,VCAM-1|At the end of each intervention, participants were asked to rest in a quiet room for half an hour. Peripheral venous blood samples were collected and centrifuged immediately. The serum were collected and stored at -80℃ within 30 minutes to minimize the in-vitro changes in biomarker proteins. P- selectin,VCAM-1(vascular cell adhesion molecule-1) were measured by using the Millipore MILLIPLEX MAP human cytokine/chemokine kit (Millipore Corp., Billerica, Massachusetts)|Up to 24 hours|||ng/ml||Standard Deviation|Geometric Mean
643478|NCT02238028|Primary|Circulating Biomarkers——Fibrinogen，vWF|At the end of each intervention, participants were asked to rest in a quiet room for half an hour. Peripheral venous blood samples were collected and centrifuged immediately. The serum were collected and stored at -80℃ within 30 minutes to minimize the in-vitro changes in biomarker proteins. Fibrinogen and von Willebrand factor(vWF) were measured by using the Millipore MILLIPLEX MAP human cytokine/chemokine kit (Millipore Corp., Billerica, Massachusetts)|Up to 24 hours|||µg/ml||Standard Deviation|Geometric Mean
643479|NCT02238028|Primary|Heart Rate Variability—pNN50|HRV is a quantitative health marker reflecting how the autonomic nervous system modulates the sinoatrial node in the heart and HRV has therefore been widely used to estimate cardiac autonomic function and control.A total of 8 parameters of HRV were analyzed including 4 time-domain indices and 4 frequency-domain indices. Subjects were attached with Holter monitor on the 2nd day in each of the 48-hr intervention period. Heart rate and heart automatic function indices including the proportion of successive normal NN intervals differing by more than 50 ms in the total number of NNs（pNN50） were automatically recorded during the intervention.|Up to 24 hours|||percentage of ms||Standard Deviation|Geometric Mean
643514|NCT02235311|Primary|Ulcer Healing|as defined by follow-up endoscopy per gastroenterology service, 8 weeks after UGIB acute management|8 weeks|1 ulcer located in duodenum, clean-base; randomized single-blinded to proton pump inhibitor (PPI) twice daily||Participants|||Count of Participants
643515|NCT02235285|Primary|Post Surgical Complications and Reoperation Rate During Breast Augmentation|The investigators reviewed 162-consecutive patients underwent breast augmentation by one surgeon for reoperation rate.|5 years|||percentage of participants||Standard Deviation|Mean
643760|NCT02229513|Secondary|Use of Methergine||Intraoperatively|||participants|||Number
643480|NCT02238028|Primary|Heart Rate Variability—LF/HF|HRV is a quantitative health marker reflecting how the autonomic nervous system modulates the sinoatrial node in the heart and HRV has therefore been widely used to estimate cardiac autonomic function and control. Subjects were attached with Holter monitor on the 2nd day in each of the 48-hr intervention period.A total of 8 parameters of HRV were analyzed including 4 time-domain indices and 4 frequency-domain indices. Frequency domain methods assign bands of frequency and then count the number of NN intervals that match each band. The bands are typically high frequency (HF) from 0.15 to 0.4 Hz, low frequency (LF) from 0.04 to 0.15 Hz. Parasympathetic activity is a major contributor to the HF component. More problematic is the interpretation of the LF component, which was considered by some as a marker of sympathetic modulation but is now known to include both sympathetic and vagal influences.|Up to 24 hours|||ratio||Standard Deviation|Geometric Mean
643481|NCT02238028|Primary|Heart Rate Variability-SDNN,SDANN, rMSSD|HRV is a quantitative health marker reflecting how the autonomic nervous system modulates the sinoatrial node in the heart and HRV has therefore been widely used to estimate cardiac autonomic function and control.A total of 8 parameters of HRV were analyzed including 4 time-domain indices and 4 frequency-domain indices. Subjects were attached with Holter monitor on the 2nd day in each of the 48-hr intervention period. Heart rate and heart automatic function indices including the standard deviation of the normal-to-normal interval(SDNN),the standard deviation of the average NN intervals calculated over short periods(SDANN), the root mean square of the successive differences(rMSSD) were automatically recorded during the intervention.|Up to 24 hours|||ms||Standard Deviation|Geometric Mean
643482|NCT02238028|Primary|Blood Pressure|The blood pressure were measured by automatic blood pressure monitor during the intervention study.|up to 24 hours|||mmHg||Standard Deviation|Mean
643483|NCT02238028|Primary|Heart Rate Variability-LF Power,HF Power,VLF Power|HRV is a quantitative health marker reflecting how the autonomic nervous system modulates the sinoatrial node in the heart and HRV has therefore been widely used to estimate cardiac autonomic function and control. Subjects were attached with Holter monitor on the 2nd day in each of the 48-hr intervention period.A total of 8 parameters of HRV were analyzed including 4 time-domain indices and 4 frequency-domain indices. Frequency domain methods assign bands of frequency and then count the number of NN intervals that match each band. The bands are typically high frequency (HF) from 0.15 to 0.4 Hz, low frequency (LF) from 0.04 to 0.15 Hz, and the very low frequency (VLF) from 0.0033 to 0.04 Hz. Parasympathetic activity is a major contributor to the HF component. More problematic is the interpretation of the LF component, which was considered by some as a marker of sympathetic modulation but is now known to include both sympathetic and vagal influences.|up to 24 hours|||ms^2||Standard Deviation|Geometric Mean
643484|NCT02237118|Secondary|Assessment of the Surrounding Skin.|assessment of the surrounding skin.|21 days|||percentage of patients|||Number
643485|NCT02237118|Secondary|Safety|Adverse Event, Adverse Device Event|21 days|||Participants|||Count of Participants
643486|NCT02237118|Secondary|Condition of the Wound, Will be Assesst by the Investigator.|wound size estimation, assesstemnt of the wound,|21 days|Missing value for some patients||Participants|||Count of Participants
643487|NCT02237118|Secondary|Complete Healing at Day 21, Will be Measured Using PictZar ( Digital Planimetric System) System.|Complete healing at day 21, will be measured using PictZar system.|21 days|||percentage of wound size reduction||Standard Deviation|Mean
643488|NCT02237118|Primary|Number of Participants With Non-Painful Dressing Removal, Measured by Visual Aanalog Scale (VAS)|To compare the effects of pain of the two dressings, Mepitel® One and UrgoTul®, during the first dressing removal. Pain measured by VAS Score ≥ 30 mm on the 100 mm VAS scale are reported.|21 days|intention to treat.Participants with None painfull dressing removal.||participants|||Number
643489|NCT02237092|Secondary|Number of Pregnants With Blocks = > Th4 With IAP Higher or Less Than 16 mm Hg||After spinal anesthesia, average 20 minutes.|||Number of pregnants with Blocks = > Th4|||Number
643490|NCT02237092|Secondary|The Level of IAP|The level of IAP in obstetric patients in the groups with high ( => Th4) and low (< = Th5) blocks|After spinal anesthesia, average 20 minutes.|||mm Hg||Standard Error|Median
643491|NCT02237092|Primary|Obesity and IAP|Effect of obesity on the level of IAP|Before spinal anesthesia, average 10 minutes.|||mm Hg||Standard Error|Median
643492|NCT02237092|Secondary|Level of Sensory Blocks|Block level of thoracic vertebrae are reported for pregnant women who had level of sensory block higher than 4 thoracic vertebra and less than 5 thoracic vertebra|After spinal anesthesia, average 20 minutes.|||Block level level of thoracic vertebrae||Standard Error|Median
643493|NCT02237092|Primary|Classification Grade of Intra-abdominal Hypertension (IAH)|Average IAP in pregnant women with different Grade of intra-abdominal hypertension Physiological norm (≤11,99 mm Hg) Grade I (12 - 15.99 mm Hg) Grade II (16 - 20.99 mm Hg) Grade III (21 - 25.99 mm Hg)|Before spinal anesthesia, average 10 minutes.|||mm Hg||Standard Error|Median
643494|NCT02237092|Primary|The Level of Intra-abdominal Pressure (IAP)|Measurement of IAP: The level of intra-abdominal pressure was measured via a Foley catheter through the urinary bladder. After the introduction of a 30 mL of warm saline. Measurement of the water column in the system was made from the zero level to the mid-axillary line, after quiet breathing pregnant at the time of expiration. The data obtained are in inches of water column were translated in millimeters of mercury.|Before spinal anesthesia, average 10 minutes.|||mm Hg||Standard Error|Median
643495|NCT02236767|Primary|The Saving Inventory-Revised (SI-R) Total Score|The Saving Inventory-Revised (SI-R) is a self-report measure which includes 23 items assessing the severity of hoarding symptoms including difficulty discarding, acquiring, and clutter. The 23 items are added for a total score which ranges from 0 to 92 and with higher score indicating more severe hoarding symptoms.|Pre-baseline, Post-baseline/Pre-treatment, Post-treatment, 2-Month Follow-up|||units on a scale|||Number
643516|NCT02235077|Other Pre-specified|Day 60 Mortality|All participants will be contacted by telephone at 60 days, +/- 3 days post randomization to assess vital status (death).|60 days post randomization|||Participants|||Count of Participants
643517|NCT02235077|Secondary|96 Hour Change in Dyspnea Visual Analog Scale|Dyspnea visual analog scale change from randomization to 96 hours. Scale range 0-100 with 100 being the best possible score.|Randomization to 96 hours|||units on a scale||Standard Deviation|Mean
643725|NCT02229864|Secondary|Number of Subjects With All Myocardial Infarction (MI)|All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI).|≤ 7 days post index procedure (In-hospital )|||Participants|||Count of Participants
643497|NCT02236598|Secondary|Changes in Insulin Sensitivity|Matsuda Insulin Sensitivity Index was calculated as: 10,000 / square root of [fasting glucose x fasting insulin x mean glucose x mean insulin during Oral Glucose Tolerance Test]).|Baseline to 3 months|||AUC - unitless,||Standard Deviation|Mean
643498|NCT02236598|Secondary|Changes in Insulin Secretion as Measured by 2-hour Insulin Area-under-the-curve (AUC)|Changes in Insulin Secretion as measured by 2-hour insulin area-under-the-curve (AUC – measured via the trapezoidal method) of 2 hours from the 3-hour OGTT.|Baseline to 3 months|||AUC - pg*min/mL||Standard Deviation|Mean
643499|NCT02236598|Secondary|Changes in Fasting, 1-hour, and 2-hour Post-challenge Glucose Levels in mg/dL|Changes in fasting, 1-hour, and 2-hour post-challenge glucose levels in mg/dL|Baseline to 3 months|||mg/dL||Standard Deviation|Mean
643500|NCT02236598|Primary|Change in Glucose Tolerance as Measured by Area-under-the-curve|Change in glucose tolerance, as measured by change in glucose area-under-the-curve (Area Under the Curve (AUC) – measured via the trapezoidal method) of 2 hours from the 3-hour Oral Glucose Tolerance Test (OGTT).|Baseline to 3 months|||AUC - mg*min/dL||Standard Deviation|Mean
643501|NCT02236546|Secondary|Changes in Tumor [18F]Fluorodeoxyglucose (FDG) Accumulation|The association between the changes in tumor FDG accumulation with a panel of immunohistochemical biomarkers will be assessed with the Spearman correlation statistic. 95% confidence intervals will be calculated for each variable. Paired changes in biomarker expression between biopsied (i.e., baseline) and biopsy samples will be compared using the nonparametric Wilcoxon signed rank test. Change in binary expression will be compared using McNemar's test. The Wilcoxon rank sum test (or Kruskal Wallis test for more than 2 groups) will be used to compare continuous and ordinal variables.|Baseline to day 21|Due to loss of funding data were not collected|||||
643502|NCT02236546|Secondary|Progression-free Survival (PFS)|Cox (proportional hazards) regression will be used to assess the association between the percent change in average standardized FDG uptake and PFS.|Time from first treatment until objective tumor progression or death for any reason, assessed up to 7 years|Due to loss of funding data were not collected|||||
643503|NCT02236546|Secondary|Objective Response (OR)|The ability of the percent change in average standardized FDG uptake to predict OR will be assessed using the proportional odds model.|Day 84|Due to loss of funding data were not collected|||||
643504|NCT02236546|Primary|Percent Change in the Sum of the Longest Dimension of Target Lesions, Defined by RECIST|The primary imaging metric is percent change in average FDG standardized uptake value (SUV) among the same target lesions between baseline and images acquired after completion of cycle 1. The relationship between tumor SUV change and size change will be assessed using standard linear regression.|Baseline to the completion of 6 courses of treatment|Due to loss of funding data were not collected|||||
643505|NCT02236130|Secondary|Patient/Family Satisfaction With Pain Management|Patient/family satisfaction on a scale of 1 to 10 with 1 least satisfied and 10 completely satisfied. Family will complete the form and return to the primary investigator at the end of day 8 after surgery in the prepaid envelope provided to them at the time of the surgery.|one week after the surgery|||Participants|||Count of Participants
643506|NCT02236130|Primary|Total Hydrocodone Dose (mg/kg)||day 2 and day 8 after the surgery|||mg/kg||Standard Deviation|Mean
643507|NCT02235831|Primary|Area for Each Region (Near and Intermediate) Under the Mean Defocus Curve (AUC) at High Luminance|Visual acuity was measured with contact lenses in place using an Early Treatment Diabetic Retinopathy Study (ETDRS) high contrast logMAR chart under well-lit conditions. Lenses of different spherical powers (+2.00 diopter to -5.00 diopter) were placed in front of the eyes to produce varying levels of defocus, and logMAR acuity at each defocus value was recorded. The area under the defocus curve (AUC) was calculated via the trapezoidal rule for the entire study population by treatment using a 0.3 logMAR threshold for intermediate from -2.00 D (50cm) to -0.50 D (2m) and near from -4.00 D (25cm) to -2.00 D (50cm). A higher value indicates a bigger area of focus. This outcome measure was prespecified for monovision and DACP MF.|Day 5, each product|This analysis population includes all randomized subjects excluding those who met the critical deviation criteria, as specified in the Deviations and Evaluability Plan (DEP).||diopter*logMar|||Number
643508|NCT02235493|Secondary|Performance-Oriented Mobility Assessment-Gait Subtest (POMA-G) - Change From Baseline to Last Overall|The POMA-G is a 7-component assessment that is used to evaluate gait performance. The second component has 4 sub-components. Scores of 0, 1 or 2 are assigned to 2 components while scores of 0 or 1 are assigned to the rest of the 4 components and 4 sub-components based on type of ambulation pattern observed. The maximum total score of 12 points = no impairment and 0 points = worst impairment.|The earliest available MPOMA-G score that was assessed within the period of patients’ aged 5 to 15 years, inclusive.|||units on a scale||Inter-Quartile Range|Median
643509|NCT02235493|Primary|Modified Performance-Oriented Mobility Assessment-Gait Subtest (MPOMA-G) - Change From Baseline to Last Overall|The MPOMA-G is a 5-component assessment that is used to evaluate gait performance. The first component has 4 sub-components. For 2 components and 2 sub-components, scores of 0 or 1 are assigned while scores of 0, 1 or 2 are assigned to the rest of the 2 components and 2 sub-components based on type of ambulation pattern observed. The maximum total score of 12 points = no impairment and 0 points = worst impairment.|The earliest available MPOMA-G score that was assessed within the period of patients’ aged 5 to 15 years, inclusive.|||units on a scale||Inter-Quartile Range|Median
643726|NCT02229864|Secondary|Number of Subjects With All Death|All death includes cardiac death, vascular death, and non-cardiac death.|0 to 758 Days|||Participants|||Count of Participants
643518|NCT02235077|Secondary|Presence of Outpatient Worsening Heart Failure Symptoms Through Day 30|Outpatient worsening heart failure symptoms will be assessed from discharge through Day 30|Hospital discharge through Day 30|All data for completed assessments was analyzed. For outcomes where the number of participants analyzed is less than 182 spironolactone / 178 placebo, the number of subjects analyzed represents the number of subjects for whom the data was collected.||Participants|||Count of Participants
643519|NCT02235077|Secondary|Change in Loop Diuretics Requirements From Baseline to 30 Days|Medications will be reviewed to assess loop diuretic dose requirements through Day 30 following randomization|Randomization through Day 30|All data for completed assessments was analyzed. For outcomes where the number of participants analyzed is less than 182 spironolactone / 178 placebo, the number of subjects analyzed represents the number of subjects for whom the data was collected.||mg||Standard Deviation|Mean
643520|NCT02235077|Secondary|96 Hour Change in Serum Potassium Levels|Change in serum potassium levels at 96 hours as compared to baseline.|Baseline, 96 hours|All data for completed assessments was analyzed. For outcomes where the number of participants analyzed is less than 182 spironolactone / 178 placebo, the number of subjects analyzed represents the number of subjects for whom the data was collected.||mEq/L||Standard Deviation|Mean
643521|NCT02235077|Secondary|96 Hour Change in Body Weight|Baseline body weight assessment will be completed, and changes in weight documented daily through 96 hours or earlier discharge|Randomization through 96 hours or earlier discharge|||pounds||Standard Deviation|Mean
643522|NCT02235077|Secondary|96 Hour Net Fluid Output|Fluid intake and urine output will be assessed daily while in hospital through 96 hours. Net fluid output (output minus input) through 96 hours is reported.|Randomization through 96 hours|All data for completed assessments was analyzed. For outcomes where the number of participants analyzed is less than 182 spironolactone / 178 placebo, the number of subjects analyzed represents the number of subjects for whom the data was collected.||ml||Standard Deviation|Mean
643523|NCT02235077|Secondary|96 Hour Change in Serum Creatinine|Renal function via serum creatinine, will be assessed at randomization and daily through 96 hours|Randomization through 96 hours|All data for completed assessments was analyzed. For outcomes where the number of participants analyzed is less than 182 spironolactone / 178 placebo, the number of subjects analyzed represents the number of subjects for whom the data was collected.||mg/dl||Standard Deviation|Mean
643524|NCT02235077|Secondary|96 Hour Change in Dyspnea Likert Score|Dyspnea relief via 7-point Likert scale will be assessed at randomization, 96 hours, and at discharge. The Likert score was defined as 1=markedly improved, 2=moderately improved, 3=minimally improved; 4=no change, 5=minimally worse, 6=moderately worse, and 7=markedly worse as compared with the degree of dyspnea present at randomization.|Randomization through 96 hours|All data for completed assessments was analyzed. For outcomes where the number of participants analyzed is less than 182 spironolactone / 178 placebo, the number of subjects analyzed represents the number of subjects for whom the data was collected.||Participants|||Count of Participants
643525|NCT02235077|Secondary|96 Hour Change in Clinical Congestion Score|Clinical congestion score will be assessed at randomization, 96 hours, and at discharge. Scale consisted of sum of six signs and symptoms of congestion, each scored 0-3. Zero indicates no sign/symptom and 3 indicates worst case of sign/symptom. Score range 0-18 with 18 being worst score.|Randomization through 96 hours|||units on a scale||Standard Deviation|Mean
643526|NCT02235077|Primary|96 Hour Change in NT-proBNP|The Core Laboratory at Vermont will determine NT-proBNP levels for calculation of the endpoint from samples obtained at randomization and 96 hours respectively. NT-proBNP was converted to log scale.|Randomization to 96 hours|||log pg/ml||Standard Deviation|Mean
643527|NCT02235064|Secondary|Perceived Infant Feeding Difficulties 12 Weeks Postpartum||12 weeks postpartum|||Participants|||Count of Participants
643528|NCT02235064|Secondary|Perceived Infant Feeding Difficulties 8 Weeks Postpartum||8 weeks postpartum|||Participants|||Count of Participants
643529|NCT02235064|Secondary|Perceived Infant Sleeping Difficulty at 12 Weeks Postpartum||12 weeks postpartum|||Participants|||Count of Participants
643530|NCT02235064|Secondary|Perceived Infant Sleeping Difficulty at 8 Weeks Postpartum||8 weeks postpartum|||Participants|||Count of Participants
643531|NCT02235064|Secondary|Reported Infant Weight at 12 Weeks Following Delivery||12 weeks postpartum|||Participants|||Count of Participants
643532|NCT02235064|Secondary|Reported Infant Weight at 8 Weeks Following Delivery||8 weeks postpartum|||Participants|||Count of Participants
643533|NCT02235064|Secondary|Perceived Infant Feeding Difficulties 4 Weeks Postpartum||4 weeks postpartum|||Participants|||Count of Participants
643534|NCT02235064|Secondary|Perceived Infant Sleeping Difficulty at 4 Weeks Postpartum||4 weeks postpartum|||Participants|||Count of Participants
643535|NCT02235064|Secondary|Reported Infant Weight at 4 Weeks Following Delivery||4 weeks postpartum|||Participants|||Count of Participants
643536|NCT02235064|Secondary|Adverse Reaction to Treatment Agent up to 12 Weeks Following Discharge From Hospital|The Antidepressant Side-Effect Checklist (ASEC) was employed to detect any adverse reaction to treatment regimens|Discharge from hospital to 12 weeks postpartum|||Participants|||Count of Participants
643537|NCT02235064|Primary|Development of Postpartum Depression up to 12 Weeks Following Discharge From Hospital|"Patients met with single psychiatrist (co-investigator), blinded to group assignment, who evaluated the patient using Edinburgh Postpartum Depression Screen, Hamilton Depression Rating Scale, Global Assessment of Functioning Scale, and clinical assessment
0 = No postpartum depression up to 12 weeks following discharge from hospital
1 = Postpartum depression up to 12 weeks following discharge from hospital"|Discharge from hospital to 12 weeks postpartum|||Participants|||Count of Participants
643538|NCT02234479|Primary|Number of Participants Whom Received Medihoney Treatment and Were Analyzed Weekly for Skin Changes While Undergoing Radiation Therapy|The aim of this study is to compare the effects of Medihoney and Hydrophor on radiation dermatitis reactions in a group of women undergoing radiation therapy for breast cancer. It is hoped that the outcome of this pilot study will provide evidence supporting the use of Medihoney in preventing and treating radiation dermatitis as well as sufficient preliminary data to expand this study to larger, federally funded research (R01) looking at the beneficial aspects of Medihoney across a spectrum of radiation dermatitis and mucositis in several disease settings.|12 months|Participants were analyzed for skin changes (during weekly visits with physician) during radiation treatment. Only 15 participants from each group completed the study, 1 subject from Group A and 3 subjects from Group B withdrew.||participants|||Number
643539|NCT02234427|Primary|Differential Gene Expression|Differences in platelet transcriptome before and after 2-week aspirin therapy The expression levels of genes before aspirin therapy was compared with the expression level of the genes after aspirin therapy. The expression levels were measured using the FPKM unit (Fragments Per Kilobase of transcript per Million mapped reads). The gene with the highest difference (pre vs. post) in FPKM is being reported with name in the units area and the actual difference in the number area|2-weeks|The data were analyzed combining results from two studies (24 from this study and additional 33 individuals from study NCT01894555; total population size = 57) to improve the power to detect a difference. Same results are reported for the two studies. Note that the top most gene (HBG1) with the lowest p-value is being reported.||FPKM for HBG1 Gene||Standard Error|Mean
643540|NCT02234362|Secondary|Change From Baseline in Digit Symbol Substitution Test (DSST) Score at Week 8 (Visit 5)|"Processing speed, working memory, visuospatial processing and attention was assessed by the Digit Symbol Substitution Test (DSST).
The DSST test requires the examinee to transcribe a unique geometric symbol with its corresponding Arabic number. The examinee is initially shown a key containing the numbers from 1 to 9. Under each number there is a corresponding geometric symbol. The examinee is then shown a series of boxes containing numbers in the top boxes, and blank boxes below them. After a short practice trial, they are then asked to copy the corresponding geometric symbol under each number. The raw score is the number of correct items completed within the prescribed time limit. Higher scores indicate faster processing speed, working memory, and visuospatial processing and attention. The range of scores is 0-63."|Baseline and Week 8 (Visit 5)|The analyzable population includes all participants who initiated treatment with vortioxetine and returned for at least one assessment after study medication initiation.||units on a scale||Inter-Quartile Range|Median
643541|NCT02234362|Secondary|Change From Baseline in Greene Climacteric Scale (GCS) Score at Week 8 (Visit 5)|"Menopause related symptoms were assessed using the Greene Climacteric Scale (GCS). The Greene Scale provides a brief measure of menopause symptoms. It can be used to assess changes in different symptoms, before and after menopause treatment. Three main areas are measured:
1. Psychological (items 1-11). 2. Physical (items 12-18). 3. Vasomotor (items 19, 20).
A higher score indicates that menopause symptoms are more bothersome. The range of scores is from 0 to 63."|Baseline and Week 8 (Visit 5)|The analyzable population includes all participants who initiated treatment with vortioxetine and returned for at least one assessment after study medication initiation.||units on a scale||Inter-Quartile Range|Median
643542|NCT02234362|Secondary|Change From Baseline in Pain Assessment (PEG) Score at Week 8 (Visit 5)|Pain symptoms were assessed by the Pain Assessment (PEG). The PEG is a three-item scale assessing pain intensity and interference. A higher score indicates more pain symptoms. The range of scores is from 0 to 30.|Baseline and Week 8 (Visit 5)|The analyzable population includes all participants who initiated treatment with vortioxetine and returned for at least one assessment after study medication initiation.||units on a scale||Inter-Quartile Range|Median
643543|NCT02234362|Secondary|Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale Score at Week 8 (Visit 5)|Severity of illness was assessed by the Clinical Global Impression-Severity (CGI-S) Scale. The CGI-S is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. The range of scores is 0-7. Higher scores indicate greater severity of illness.|Baseline and Week 8 (Visit 5)|The analyzable population includes all participants who initiated treatment with vortioxetine and returned for at least one assessment after study medication initiation.||units on a scale||Inter-Quartile Range|Median
643544|NCT02234362|Secondary|Change From Baseline in Clinical Global Impression-Fatigue (CGI-F) Scale Score at Week 8 (Visit 5)|Fatigue symptoms were assessed by the Clinical Global Impression-Fatigue (CGI-F) scale.The CGI-F is a single item global assessment scales to specifically evaluate symptoms of fatigue. Higher scores indicate more fatigue symptoms. The range of scores is from 0-7.|Baseline and Week 8 (Visit 5)|The analyzable population includes all participants who initiated treatment with vortioxetine and returned for at least one assessment after study medication initiation.||units on a scale||Inter-Quartile Range|Median
643545|NCT02234362|Secondary|Change From Baseline in Menopause Specific Quality of Life (MENQOL) Score at Week 8 (Visit 5)|"Quality of life, menopause-specific, is assessed by the Menopause Specific Quality of Life (MENQOL).
The MENQOL is self-administered and consists of a total of 29 items in a Likert-scale format. Each item assesses the impact of one of four domains of menopausal symptoms, as experienced over the last month: vasomotor (items 1-3), psychosocial (items 4-10), physical (items 11-26), and sexual (items 27-29). Items pertaining to a specific symptom are rated as present or not present, and if present, how bothersome on a zero (not bothersome) to six (extremely bothersome) scale. Means are computed for each subscale by dividing the sum of the domain's items by the number of items within that domain. Non-endorsement of an item is scored a 1 and endorsement a 2, plus the number of the particular rating, so that the possible score on any item ranges from 1-8. Total score also ranges from 1-8. Higher scores indicate that menopause symptoms are more bothersome."|Baseline and Week 8 (Visit 5)|The analyzable population includes all participants who initiated treatment with vortioxetine and returned for at least one assessment after study medication initiation.||units on a scale||Inter-Quartile Range|Median
643546|NCT02234362|Secondary|Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Score at Week 8 (Visit 5)|Sleep quality and disturbances during the past month were assessed with the Pittsburgh Sleep Quality Index (PSQI). The PSQI also incorporates daytime functioning into the total score. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality. The range of scores is 0-21.|Baseline and Week 8 (Visit 5)|The analyzable population includes all participants who initiated treatment with vortioxetine and returned for at least one assessment after study medication initiation.||units on a scale||Inter-Quartile Range|Median
643626|NCT02231918|Secondary|Vital Signs (Systolic and Diastolic Blood Pressure)|Vital signs (Systolic and diastolic blood pressure (both supine and after standing for 1 minute)).|-0:15h(hours) pre-dose, and 0:30h, 1:00h, 2:00h, 3:00h, 5:00h, 7:00h, 12:00h, 24:00h post-dose.|Safety analysis set: The safety population comprised all patients who provided informed consent and received at least one dose of study drug.||mmHg||Standard Deviation|Mean
643547|NCT02234362|Secondary|Change From Baseline in Beck Anxiety Inventory (BAI) Score at Week 8 (Visit 5)|Anxiety was measured by self-report responses to Beck Anxiety Inventory (BAI). It is a 21-question multiple-choice self-report inventory that is used for measuring the severity of anxiety in children and adults. Several studies have found the Beck Anxiety Inventory to be an accurate measure of anxiety symptoms in children and adults. Higher scores on the BAI indicate more anxiety symptoms. The range of BAI scores is from 0 to 63, with 0-9=Minimal anxiety, 10-16=Mild anxiety, 17-29=Moderate anxiety, and 30-63=Severe anxiety.|Baseline and Week 8 (Visit 5)|The analyzable population includes all participants who initiated treatment with vortioxetine and returned for at least one assessment after study medication initiation.||units on a scale||Inter-Quartile Range|Median
643548|NCT02234362|Secondary|Change From Baseline in Cognitive and Physical Functioning Questionnaire (CPFQ) Score at Week 8 (Visit 5)|Cognition and physical functioning was measured by self-report responses to Cognitive and Physical Functioning Questionnaire (CPFQ).The range of scores is from 7-42. Higher scores indicate lower cognitive and executive functioning.|Baseline and Week 8 (Visit 5)|The analyzable population includes all participants who initiated treatment with vortioxetine and returned for at least one assessment after study medication initiation.||units on a scale||Inter-Quartile Range|Median
643549|NCT02234362|Secondary|Change From Baseline in Vasomotor Symptoms (VMS) Severity During Nighttime at Week 8 (Visit 5)|"Vasomotor symptoms (VMS) were tracked and quantified prospectively using a daily hot flash diary. The hot flash diary was adapted from a 7-day self-report tool for vasomotor symptoms originally developed by the North Central Cancer Treatment Group (NCCTG). The diary asks for the subject to log number of hot flashes during the day and night, severity of hot flashes during day and night, and how bothersome the hot flashes were during day and night.
Severity of VMS:
The range of scores for severity of VMS is 0-2, with higher scores indicating greater severity. 0=mild, 1=moderate, 2=severe"|Baseline and Week 8 (Visit 5)|The analyzable population includes all participants who initiated treatment with vortioxetine and returned for at least one assessment after study medication initiation who also reported having hot flashes at baseline.||units on a scale||Standard Deviation|Mean
643550|NCT02234362|Secondary|Change From Baseline in Vasomotor Symptoms (VMS) Frequency During Nighttime at Week 8 (Visit 5)|Vasomotor symptoms (VMS) were tracked and quantified prospectively using a daily hot flash diary. The hot flash diary was adapted from a 7-day self-report tool for vasomotor symptoms originally developed by the North Central Cancer Treatment Group (NCCTG). The diary asks for the subject to log number of hot flashes during the day and night, severity of hot flashes during day and night, and how bothersome the hot flashes were during day and night.|Baseline and Week 8 (Visit 5)|The analyzable population includes all participants who initiated treatment with vortioxetine and returned for at least one assessment after study medication initiation who also reported having hot flashes at baseline.||hot flashes per night||Standard Deviation|Mean
643551|NCT02234362|Secondary|Change From Baseline in Vasomotor Symptoms (VMS) Severity During Daytime at Week 8 (Visit 5)|"Vasomotor symptoms (VMS) were tracked and quantified prospectively using a daily hot flash diary. The hot flash diary was adapted from a 7-day self-report tool for vasomotor symptoms originally developed by the North Central Cancer Treatment Group (NCCTG). The diary asks for the subject to log number of hot flashes during the day and night, severity of hot flashes during day and night, and how bothersome the hot flashes were during day and night.
Severity of VMS:
The range of scores for severity of VMS is 0-2, with higher scores indicating greater severity. 0=mild, 1=moderate, 2=severe"|Baseline and Week 8 (Visit 5)|The analyzable population includes all participants who initiated treatment with vortioxetine and returned for at least one assessment after study medication initiation who also reported having hot flashes at baseline.||units on a scale||Standard Deviation|Mean
643552|NCT02234362|Secondary|Change From Baseline in Vasomotor Symptoms (VMS) Frequency During Daytime at Week 8 (Visit 5)|Vasomotor symptoms (VMS) were tracked and quantified prospectively using a daily hot flash diary. The hot flash diary was adapted from a 7-day self-report tool for vasomotor symptoms originally developed by the North Central Cancer Treatment Group (NCCTG). The diary asks for the subject to log number of hot flashes during the day and night, severity of hot flashes during day and night, and how bothersome the hot flashes were during day and night.|Baseline and Week 8 (Visit 5)|The analyzable population includes all participants who initiated treatment with vortioxetine and returned for at least one assessment after study medication initiation who also reported having hot flashes at baseline.||hot flashes per day||Standard Deviation|Mean
643553|NCT02234362|Primary|Change From Baseline in Montgomery-Asberg Depression Rating Scale Score (MADRS) at Week 8 (Visit 5)|The efficacy of vortioxetine for trea-ting depressive symptoms was measured by mean change in Montgomery-Asberg Depression Rating Scale (MADRS) depression score from Baseline (Visit 1) to Week 8 (Visit 5). The MADRS score was assessed at every study visit (Visits 1-5). Participants were considered to have responded to vortioxetine if their MADRS score was reduced by 50% or more from baseline to the end of treatment, and to be in remission if their final MADRS score was less than 10. Higher MADRS score indicates more severe depression. The overall MADRS score ranges from 0 to 60.|Baseline and Week 8 (Visit 5)|The analyzable population includes all 24 participants who initiated medication treatment and returned for at least one assessment after starting vortioxetine. A last observation carried forward (LOCF) analysis was used.||units on a scale||Standard Deviation|Mean
643554|NCT02234011|Primary|Observing if Ketamine May Cause a Decrease in OCD Symptoms|"Examining if ketamine is associated with a decrease in OCD symptoms as measured by the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) at completion of one treatment when compared to placebo (saline solution).
The Y-BOCS measures OCD symptoms on a scale of 0-40, with higher numbers indicating greater severity of OCD symptoms. For this study, subjects had to have a Y-BOCS of greater than or equal to 18 in order to participate."|Baseline to Week 5|One subject had a screening visit, but was never enrolled in the treatment portion and therefore never had any sort of treatment analysis performed on her data.|||||
643582|NCT02233647|Secondary|"Peak Ratings of Performance Improved on the Visual Analog Scale"|"Subjects rated their feelings of Performance Improved on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
643727|NCT02229864|Secondary|Number of Subjects With All Death|All death includes cardiac death, vascular death, and non-cardiac death.|0 to 393 Days|||Participants|||Count of Participants
643555|NCT02233998|Secondary|Change From Baseline in the Percentage of Problem Sites (Plaque Index (PI) Scores of ≥ 2) at Week 3|Plaque area was measured based on the Turesky modification of the Quigley-Hein Plaque Index and was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) of all scorable teeth, following disclosing, according to the following scale: 0: No plaque, 1: Separate flecks or discontinuous band of plaque at the gingival (cervical) margin, 2: Thin (up to 1 mm), continuous band of plaque at the gingival margin, 3: Band of plaque wider than 1 mm but less than 1/3 of surface, 4: Plaque covering 1/3 or more, but less than 2/3 of surface, 5: Plaque covering 2/3 or more of surface. The score for each participant was the change from baseline (i.e., Baseline Score minus Week 3 Score) in the percentage of sites with a PI score ≥2 at Week 3.|Baseline to 3 Weeks|Analysis was based on the Full Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||percentage of PI scores of >= 2||Standard Deviation|Mean
643556|NCT02233998|Secondary|Change From Baseline in the Percentage of Problem Sites (Plaque Index (PI) Scores of ≥ 3) at Week 3|Plaque area was measured based on the Turesky modification of the Quigley-Hein Plaque Index and was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) of all scorable teeth, following disclosing, according to the following scale: 0: No plaque, 1: Separate flecks or discontinuous band of plaque at the gingival (cervical) margin, 2: Thin (up to 1 mm), continuous band of plaque at the gingival margin, 3: Band of plaque wider than 1 mm but less than 1/3 of surface, 4: Plaque covering 1/3 or more, but less than 2/3 of surface, 5: Plaque covering 2/3 or more of surface. The score for each participant was the change from baseline (i.e., Baseline Score minus Week 3 Score) in the percentage of sites with a PI score ≥3 at Week 3.|Baseline to 3 Weeks|Analysis was based on the Full Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||percentage of PI scores of >= 3||Standard Deviation|Mean
643557|NCT02233998|Secondary|Change From Baseline in the Percentage of Problem Sites (Modified Gingival Index (MGI) Scores of ≥ 3) at Week 3|Gingivitis was assessed on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth according to the following scale: 0: Normal (absence of inflammation), 1: Mild inflammation (slight change in color, little change in texture) of any portion of the gingival unit, 2: Mild inflammation of the entire gingival unit, 3: Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit, and 4: Severe inflammation marked redness, edema and/ or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. The score for each participant was the change from baseline (i.e., Baseline Score minus Week 3 Score) in the percentage of sites with an MGI score ≥3 at Week 3.|Baseline to 3 Weeks|Analysis was based on the Full Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||percentage of MGI scores of >= 3||Standard Deviation|Mean
643558|NCT02233998|Secondary|Change From Baseline in the Percentage of Non-Bleeding Sites (Gingival Bleeding Index (BI) Scores of 0) at Week 3|Bleeding was assessed using a periodontal probe with a 0.5 mm diameter tip which was inserted into the gingival crevice, and swept from distal to mesial, around the tooth at an angle of approximately 60 degrees, while in contact with the sulcular epithelium. Each of 4 gingival areas (disto-buccal, midbuccal, mid-lingual, and mesio-lingual) around each tooth was assessed. After approximately 30 seconds, bleeding at each gingival unit was recorded according to the following scale: 0: Absence of bleeding after 30 seconds, 1: Bleeding after 30 seconds, and 2: Immediate bleeding. The score for each participant was the change from baseline in the percentage of sites with a BI score of 0 at Week 3.|Baseline to 3 Weeks|Analysis was based on the Full Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||percentage of BI scores of 0||Standard Deviation|Mean
643559|NCT02233998|Secondary|Change From Baseline in the Percentage of Virtually Plaque-Free Sites (Plaque Index (PI) Scores of 0 or 1) at Week 3|Plaque area was measured based on the Turesky modification of the Quigley-Hein Plaque Index and was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) of all scorable teeth, following disclosing, according to the following scale: 0: No plaque, 1: Separate flecks or discontinuous band of plaque at the gingival (cervical) margin, 2: Thin (up to 1 mm), continuous band of plaque at the gingival margin, 3: Band of plaque wider than 1 mm but less than 1/3 of surface, 4: Plaque covering 1/3 or more, but less than 2/3 of surface, 5: Plaque covering 2/3 or more of surface. The score for each participant was the change from baseline in the percentage of sites with a PI score of 0 or 1 at Week 3.|Baseline to 3 Weeks|Analysis was based on the Full Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||percentage of PI scores of 0 or 1||Standard Deviation|Mean
643560|NCT02233998|Secondary|Change From Baseline in the Percentage of Healthy Sites (Modified Gingival Index (MGI) Scores of 0 or 1) at Week 3|Gingivitis was assessed on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth according to the following scale: 0: Normal (absence of inflammation), 1: Mild inflammation (slight change in color, little change in texture) of any portion of the gingival unit, 2: Mild inflammation of the entire gingival unit, 3: Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit, and 4: Severe inflammation marked redness, edema and/ or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. The score for each participant was the change from baseline in the percentage of sites with an MGI score of 0 or 1 at Week 3.|Baseline to 3 Weeks|Analysis was based on the Full Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||percentage of MGI scores of 0 or 1||Standard Deviation|Mean
643583|NCT02233647|Secondary|"Peak Ratings of Performance Impaired on the Visual Analog Scale"|"Subjects rated their feelings of Performance Impaired on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
643761|NCT02229513|Other Pre-specified|Uterine Temperature After Wrap Removed||Immediately following hysterotomy repair|||degrees Fahrenheit||Standard Deviation|Mean
643561|NCT02233998|Secondary|Whole Mouth Mean Gingival Bleeding Index (BI) at Week 3|Bleeding was assessed using a periodontal probe with a 0.5 mm diameter tip which was inserted into the gingival crevice, and swept from distal to mesial, around the tooth at an angle of approximately 60 degrees, while in contact with the sulcular epithelium. Each of 4 gingival areas (disto-buccal, midbuccal, mid-lingual, and mesio-lingual) around each tooth was assessed. After approximately 30 seconds, bleeding at each gingival unit was recorded according to the following scale: 0: Absence of bleeding after 30 seconds, 1: Bleeding after 30 seconds, and 2: Immediate bleeding. The score for each participant was calculated by averaging their tooth site scores at Week 3.|3 Weeks|Analysis was based on the Full Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
643562|NCT02233998|Primary|Whole Mouth Mean Plaque Index (PI) at Week 3|Plaque area was measured based on the Turesky modification of the Quigley-Hein Plaque Index and was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) of all scorable teeth, following disclosing, according to the following scale: 0: No plaque, 1: Separate flecks or discontinuous band of plaque at the gingival (cervical) margin, 2: Thin (up to 1 mm), continuous band of plaque at the gingival margin, 3: Band of plaque wider than 1 mm but less than 1/3 of surface, 4: Plaque covering 1/3 or more, but less than 2/3 of surface, 5: Plaque covering 2/3 or more of surface. The score for each participant was calculated by averaging their tooth site scores at Week 3.|3 Weeks|Analysis was based on the Full Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
643563|NCT02233998|Primary|Whole Mouth Mean Modified Gingival Index (MGI) at Week 3|Gingivitis was assessed on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth according to the following scale: 0: Normal (absence of inflammation), 1: Mild inflammation (slight change in color, little change in texture) of any portion of the gingival unit, 2: Mild inflammation of the entire gingival unit, 3: Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit, and 4: Severe inflammation marked redness, edema and/ or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. The score for each participant was calculated by averaging their tooth site scores at Week 3.|3 Weeks|Analysis was based on the Full Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
643564|NCT02233985|Secondary|Frequency of Complications of the Disease Itself|The presence or absence of clinical data to warrant dehydration of hydration, infected by bacteria, pneumothorax, interstitial emphysema and subcutaneous be evaluated.|Throughout the stay for each patient until discharge. Follow-up will be continued for a period of 30 days in which they may present readmissions, complications or adverse effects.||05/2017||||
643565|NCT02233985|Secondary|Hospital Readmission|After the first admission of each patient will be evaluated during the next 30 days, if a patient is readmitted for any respiratory disease, respiratory distress, pneumonia or bronchiolitis. Considering as non-serious risks that do not compromise life, tachycardia, tremor, increased access to cough immediately to the inhalation, as well as the ardor of nasal mucosa, all these with limited characteristics, however, these do not put at risk The health of the patient, so they were not measured.|Throughout the stay for each patient until discharge. Follow-up will be continued for a period of 30 days in which they may present readmissions, complications or adverse effects.||05/2017||||
643566|NCT02233985|Primary|Hours of Hospital Stay|Each patient record the time of entry and measured the total hospital stay time in hours, recording the time of discharge to determine the total stay in hours. The hospital stay will be evaluated in hours. Staying hospitalized until they had mild respiratory stage scale scores for at least 2 hrs.|Throughout the stay for each patient until discharge. Follow-up will be continued for a period of 30 days in which they may present readmissions, complications or adverse effects.|All patients included in the study, underwent measurement of hours of hospital stay from admission to pediatric emergencies to hospital discharge.||hours||95% Confidence Interval|Median
643567|NCT02233985|Primary|Score Respiratory Distress|It is a validated clinical scale, sufficiently reliable measure of Severity of the respiratory distress. It consists of the summation score of the sibilance / crackling parameters (the largest of them), respiratory effort, pulmonary air inlet, oxygen saturation, heart rate and breathing rate. It is stratified into 3 levels of severity: mild from 0 to 5 points, moderate from 6 to 10 and severe from 10 to 16.|Basal, 30 minutes after the end of the first 3 continuous nebulization sessions, at 4 hours, 8 hours and every 24 hours during the entire hospital stay|All patients with respiratory distress in moderate to severe stage until a stage of mild respiratory distress or difficulty breathing submitted.||units on a scale||95% Confidence Interval|Median
643568|NCT02233842|Primary|Time From Cancer Diagnosis to the Date of the Interview|Patients diagnosed with cancer who participated in the Cancer Patient Tobacco Use Questionnaire (C-TUQ).|up to 24 years|||years||Full Range|Median
643569|NCT02233842|Primary|Number of Current and Former Smokers Who Smoked Cigarettes at the Time of Their Cancer Diagnosis|Current and former smokers who were smoking at the time of their cancer diagnosis.|Day 1 of interview|||participants|||Number
643570|NCT02233842|Primary|Number of Smokers at the Time of the Interview|Current, former, and cigar smokers at the time the interview (e.g. Cancer Patient Tobacco Use Questionnaire (C-TUQ)) was initiated.|Day 1 of interview|||participants|||Number
643571|NCT02233842|Primary|Number of Participants to Achieve Saturation in an English-language Paper Questionnaire|Saturation is defined as satisfactory measurement of performance without need of further review.|Last subject interviewed, an average of 5 months|||participants|||Number
643584|NCT02233647|Secondary|"Peak Ratings of Willing to Pay For on the Visual Analog Scale"|"Subjects rated their feelings of Willing to Pay For on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
643728|NCT02229864|Secondary|Number of Subjects With All Death|All death includes cardiac death, vascular death, and non-cardiac death.|0 to 208 Days|||Participants|||Count of Participants
643572|NCT02233803|Secondary|Change From BL in Asthma Control Test (ACT) at 4 Wks for Each TP|ACT was basically a five item questionnaire, to measure participant’s asthma control. It comprised of five possible answers to each question, associated with a score of 1 to 5 (1=poor control and 5=good control), wherein the scores from each question were summed to give an overall score (5=poor control and 25=complete control). ACT was recommended during each visit and was completed by the participant before any procedures were performed, avoiding any influence of the participants response. Change from BL was analysed using mixed effects ANCOVA model fitting terms for subject-level (SL) BL, Adjusted period-specific(PS) BL, treatment group and period, with participant as random effect. PS BL value, is pre-dose assessment collected on D1 of each TP. SL BL, is arithmetic mean of PS BL values of participant. Participants with an ACT below 15 were excluded from the study.|BL up to W4 (each TP)|ITT population. Only those participants with data available at the indicated time points were analyzed.||units on scale||Standard Error|Least Squares Mean
643573|NCT02233803|Secondary|FEV1 Area Under the Curve (AUC) (0-10 h) at D1 of Each TP|FEV1 is the maximal amount of air that can be forcefully exhaled in one second. FEV1 AUC (0 to 10h) was measured at beginning of each TP. AUC was derived using values observed at the following timepoints: 0 minute (pre-morning dosing), 5 minutes (m), 15m, 30m, 1, 2, 5, and 10h; post morning dosing FEV1 values on D1 of each TP. Pre-dose was taken as, 0h timepoint on the visit of interest, and all subsequent timepoints were calculated relative to that timepoint. FEV1 AUC was analysed using mixed effects ANCOVA model fitting terms for subject-level (SL) BL, Adjusted period-specific(PS) BL, treatment group and period, with participant as random effect.|(0-10 h) at D1 (each TP)|ITT population. Only those participants with data available at the indicated time points were analyzed.||L*hrs||Standard Error|Least Squares Mean
643574|NCT02233803|Primary|Change From Baseline (BL) in Trough Morning Forced Expiratory Volume in One Second (FEV1) at Day (D)29|FEV1 is maximal amount of air, forcefully exhaled in one second. Trough FEV1 is defined as morning prebronchodilator and predose: 12 hours (h) after last evening dose D28 at end of each TP. Measured by spirometer in morning, before using bronchodilator and pre-dosing at wk1 D1 and wk4 D29 of each TP and test was performed within 30 minutes prior to dosing. Change from BL was analysed using mixed effects ANCOVA model fitting terms for subject-level (SL) BL, Adjusted period-specific (PS) BL, treatment group and period, with participant as random effect. PS BL value is pre-dose assessment collected on D1 of each TP. SL BL is arithmetic mean of PS BL values of participant. If only one of PS BL value is missing for participant, SL BL took value of other BL. If both PS BL values were missing, SL BL was set to missing. Period level BL=PS BL - associated SL BL.|BL (D1) and D29 (each TP)|The intent to treat (ITT) population comprised of all randomized participants who received at least one dose of study treatment. This population was based on the treatment to which the participant was randomized. Only those participants with data available at the indicated time points were analyzed.||Litre (L)||Standard Error|Least Squares Mean
643575|NCT02233647|Secondary|"Peak Ratings of Talkative/Friendly on the Visual Analog Scale"|"Subjects rated their feelings of Talkative/Friendly on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
643576|NCT02233647|Secondary|"Peak Ratings of Willing to Take Again on the Visual Analog Scale"|"Subjects rated their feelings of Willing to Take Again on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
643577|NCT02233647|Secondary|"Peak Ratings of Stimulated on the Visual Analog Scale"|"Subjects rated their feelings of Stimulated on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
643578|NCT02233647|Secondary|"Peak Ratings of Sluggish/Fatigued/Lazy on the Visual Analog Scale"|"Subjects rated their feelings of Sluggish/Fatigued/Lazy on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
643579|NCT02233647|Secondary|"Peak Ratings of Shaky/Jittery on the Visual Analog Scale"|"Subjects rated their feelings of Shaky/Jittery on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
643580|NCT02233647|Secondary|"Peak Ratings of Rush on the Visual Analog Scale"|"Subjects rated their feelings of Rush on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
643581|NCT02233647|Secondary|"Peak Ratings of Restless on the Visual Analog Scale"|"Subjects rated their feelings of Restless on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
643585|NCT02233647|Secondary|"Peak Ratings of Nervous/Anxious on the Visual Analog Scale"|"Subjects rated their feelings of Nervous/Anxious on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
643586|NCT02233647|Secondary|"Peak Ratings of Nauseated/Queasy/Sick to Stomach on the Visual Analog Scale"|"Subjects rated their feelings of Nauseated/Queasy/Sick to Stomach on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
643587|NCT02233647|Secondary|"Peak Ratings of Like Drug on the Visual Analog Scale"|"Subjects rated their feelings of Like Drug on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
643588|NCT02233647|Secondary|"Peak Ratings of Irregular/Racing Heartbeat on the Visual Analog Scale"|"Subjects rated their feelings of Irregular/Racing Heartbeat on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
643589|NCT02233647|Secondary|"Peak Ratings of High on the Visual Analog Scale"|"Subjects rated their feelings of High on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
643590|NCT02233647|Secondary|"Peak Ratings of Good Effect on the Visual Analog Scale"|"Subjects rated their feelings of Good Effect on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
643591|NCT02233647|Secondary|"Peak Ratings of Euphoric on the Visual Analog Scale"|"Subjects rated their feelings of Euphoric on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
643592|NCT02233647|Secondary|"Peak Ratings of Bad Effect on the Visual Analog Scale"|"Subjects rated their feelings of Bad Effect on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
643593|NCT02233647|Secondary|"Peak Ratings of Any Effect on the Visual Analog Scale"|"Subjects rated their feelings of Any Effect on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
643594|NCT02233647|Secondary|"Peak Ratings of Active, Alert, Energetic on the Visual Analog Scale"|"Subjects rated their feelings of Active, Alert, Energetic on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
643595|NCT02233647|Secondary|Peak Score on Stimulant Subscale of the Adjective Rating Scale|"Subjects completed 16 items that loaded into the Stimulant Subscale of the Adjective Rating Scale. The items were rated 0-4 on a Likert-type scale and the sum for the 16 stimulant items was summed to yield the Stimulant Subscale score. The maximum score for this scale was 64, the minimum was 0. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
643623|NCT02232126|Secondary|30-day Readmission Among Intervention Participants|The outcome measure is the rate of 30-day readmissions among Intervention group participants that declined to receive the in-home social work intervention versus those Intervention group participants that received the in-home social work intervention.|30-days|Analysis among Intervention group ONLY for this outcome||30-day hospital readmissions|||Number
643729|NCT02229864|Secondary|Number of Subjects With All Death|All death includes cardiac death, vascular death, and non-cardiac death.|0 to 37 Days|||Participants|||Count of Participants
643596|NCT02233647|Secondary|Peak Score on Sedative Subscale of the Adjective Rating Scale|"Subjects completed 16 items that loaded into the Sedative Subscale of the Adjective Rating Scale. The items were rated 0-4 on a Likert-type scale and the sum for the 16 sedative items was summed to yield the Sedative Subscale score. The maximum score for this scale was 64, the minimum was 0. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
643597|NCT02233647|Primary|Peak Temperature|Oral temperature was measured with an automated monitor. Higher values represent greater temperature. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo maintenance conditions.|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.|||Degrees Fahrenheit||Standard Error|Mean
643598|NCT02233647|Primary|Peak Heart Rate|Heart rate was measured with an automated monitor. Higher values represent greater heart rate. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo maintenance conditions.|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.|||Beats per Minute||Standard Error|Mean
643599|NCT02233647|Primary|Peak Diastolic Pressure|Diastolic blood pressure was measured with an automated monitor. Higher values represent greater diastolic pressure. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo maintenance conditions.|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.|||mm Hg||Standard Error|Mean
643600|NCT02233647|Primary|Peak Systolic Pressure|Systolic blood pressure was measured with an automated monitor. Higher values represent greater systolic pressure. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo maintenance conditions.|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.|||mm Hg||Standard Error|Mean
643601|NCT02233309|Primary|Pressure in the Caudal Epidural Space|After administration of the single-shot bolus dose of the local anesthetic agent (1 mL/kg), the immediate post-bolus pressure was measured.|Immediately post bolus|Due to errors in data collection or protocol violations, 5 patients were excluded leaving 31 patients for analysis.||mmHg||Standard Deviation|Mean
643602|NCT02233296|Primary|Pharmacokinetics - AUC0-inf (ng.h/mL)|This study was designed to estimate the relative bioavailability of lasmiditan 200 mg in the fed state relative to the fasted state. For each primary pharmacokinetic endpoint, i.e., Area under concentration curve (time zero to last, time zero to infinity), Maximum concentration, point estimates and corresponding 90% confidence intervals were constructed. Duration of the study was approximately 5 weeks, including up to 3 weeks for screening and 16 days on study (2 - 3 day dosing periods, 6 day washout period and follow-up).|Sequential timepoints on each dosing day pre-dose to 30 h (timepoints - pre-dose and then 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 30 hours post dose)|"all subjects with evaluable PK data according to the following criteria:
completion of both treatment regimens,
availability of measurements of the primary PK variable(s) for both treatments (Cmax and AUC0-inf or AUC0-t),
absence of any important protocol deviation that would have rendered the data incomparable between treatments"||ng.h/mL||Standard Deviation|Mean
643603|NCT02233296|Primary|Pharmacokinetics - AUC0-t (ng.h/mL)|This study was designed to estimate the relative bioavailability of lasmiditan 200 mg in the fed state relative to the fasted state. For each primary pharmacokinetic endpoint, i.e., Area under concentration curve (time zero to last, time zero to infinity), Maximum concentration, point estimates and corresponding 90% confidence intervals were constructed. Duration of the study was approximately 5 weeks, including up to 3 weeks for screening and 16 days on study (2 - 3 day dosing periods, 6 day washout period and follow-up).|Sequential timepoints on each dosing day pre-dose to 30 h (timepoints - pre-dose and then 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 30 hours post dose)|"all subjects with evaluable PK data according to the following criteria:
completion of both treatment regimens,
availability of measurements of the primary PK variable(s) for both treatments (Cmax and AUC0-inf or AUC0-t),
absence of any important protocol deviation that would have rendered the data incomparable between treatments"||ng.h/mL||Standard Deviation|Mean
643604|NCT02233296|Secondary|Tolerability|Tolerability was defined as the number of subjects that did not withdraw from the study early due to adverse events.|15 days|All the subjects included in the study who received at least one dose of lasmiditan (n=30). Subject disposition was considered for all subjects under the fed condition and then all subjects under the fasted condition not per sequence of dosing (fed/fasted or fasted/fed).||participants|||Number
643605|NCT02233296|Secondary|Safety. Safety Measurements Include Physical Exams, Vital Signs, ECGs, Clinical Laboratory Assessments, AEs, Columbia Suicide Severity Rating Scale (C-SSRS).|Safety was evaluated in all subjects (n=30) under the fasted condition and the fed condition, not by sequence of assigned cross-over (fed/fasted or fasted/fed). The number of unique subjects with an AE and the number of events are provided.|Duration of study- From Screening (signing informed consent form) to End-of-Study ~ 15 days|All the subjects included in the study who received at least one dose of lasmiditan (n=30). Adverse events were considered in all subjects under the fed condition and then in all subjects under the fasted condition not per sequence of dosing (fed/fasted or fasted/fed).||participants with adverse events|||Number
643606|NCT02233296|Primary|Pharmacokinetics - Tmax (Hours)|This study was designed to estimate the relative bioavailability of lasmiditan 200 mg in the fed state relative to the fasted state. For each primary pharmacokinetic endpoint, i.e., Area under concentration curve (time zero to last, time zero to infinity), Maximum concentration, point estimates and corresponding 90% confidence intervals were constructed. Duration of the study was approximately 5 weeks, including up to 3 weeks for screening and 16 days on study (2 - 3 day dosing periods, 6 day washout period and follow-up).|Sequential timepoints on each dosing day pre-dose to 30 h (timepoints - pre-dose and then 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 30 hours post dose)|"all subjects with evaluable PK data according to the following criteria:
completion of both treatment regimens,
availability of measurements of the primary PK variable(s) for both treatments (Cmax and AUC0-inf or AUC0-t),
absence of any important protocol deviation that would have rendered the data incomparable between treatments"||hours||Standard Deviation|Mean
643607|NCT02233296|Primary|Pharmacokinetics - Cmax (ng/mL)|This study was designed to estimate the relative bioavailability of lasmiditan 200 mg in the fed state relative to the fasted state. For each primary pharmacokinetic endpoint, i.e., Area under concentration curve (time zero to last, time zero to infinity), Maximum concentration, point estimates and corresponding 90% confidence intervals were constructed. Duration of the study was approximately 5 weeks, including up to 3 weeks for screening and 16 days on study (2 - 3 day dosing periods, 6 day washout period and follow-up).|Sequential timepoints on each dosing day pre-dose to 30 h (timepoints - pre-dose and then 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 30 hours post dose)|"all subjects with evaluable PK data according to the following criteria:
completion of both treatment regimens,
availability of measurements of the primary PK variable(s) for both treatments (Cmax and AUC0-inf or AUC0-t),
absence of any important protocol deviation that would have rendered the data incomparable between treatments"||ng/mL||Standard Deviation|Mean
643608|NCT02233101|Secondary|Other Complications|"Any other complications listed below:
DVT or PE
Return to the OR within 30 days
Re-admission within 30 days
Superficial infection
Deep infection
Periprosthetic fracture
Cerebrovascular accident or Transient ischemic attack
Dislocation"|participants will be followed for the duration of hospital stay, an expected average of no more than 30 days|||participants|||Number
643609|NCT02233101|Primary|Requirement for Blood Transfusion|Patient hemoglobin will be measured during and after surgery for the first 24 hours to determine if a blood transfusion is indicated.|during or within 24 hours after surgery|||participants|||Number
643610|NCT02232880|Secondary|Change in Inflammatory Markers|changes in plasma and T cell markers of activation and T cell cytokine production from randomization to end of 24 weeks of treatment|6 months|No patients received treatment prior to study termination|||||
643611|NCT02232880|Secondary|Change in Brachial Artery Reactivity|change in brachial artery reactivity measured at randomization and after 24 weeks of treatment|6 months|No patients received treatment prior to study termination|||||
643612|NCT02232880|Secondary|Change in Blood Pressure|Changes in the rate of change of blood pressure estimated by automated in office cuff measurements and ambulatory blood pressure at 12 weeks after randomization|6 months|No patients received treatment prior to study termination.|||||
643613|NCT02232880|Primary|Change in Systolic Blood Pressure From Randomization to End of Treatment|Ambulatory blood pressure monitoring will be used at the end of the 4 weeks standardized treatment and at the end of 6 months randomized treatment with abatacept or placebo. The change in systolic blood pressure from these 2 recordings will be the primary endpoint.|6 months|No patients received treatment prior to study termination|||||
643614|NCT02232698|Secondary|Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 208|"The Diabetes Treatment Satisfaction Questionnaire change (DTSQc) score is used to assess relative change in participant satisfaction from baseline. The questionnaire consists of 8 items, 6 of which (1 and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale (which ranges from -3 (much less satisfied) to +3 (much more satisfied). The scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from -18 (much less satisfied) to +18 (much more satisfied).
There is one question to assess the change in perceived frequency of Hypoglycaemia and one question to assess change in perceived frequency of Hyperglycaemia. Each question is rated on a 7-point Likert scale (-3 to +3), -3 (much less of the time now) to +3 (much more of the time now).
The ANCOVA adjusts for baseline DTSQs (status version)."|Baseline and Day 208|||units on a scale||Standard Deviation|Mean
643615|NCT02232698|Secondary|System Utilisation|System utilisation assessed by percentage of sensor glucose data collected by the intervention group|Days 15 to 208|112 subjects included in the analysis, 7 were not included due to missing data.||percentage of sensor glucose collected||Standard Deviation|Mean
643616|NCT02232698|Secondary|Number of Glucose Measurements Performed|Number of blood glucose fingerstick tests per day by intervention and control group during baseline (days 1 to 15) and days 194 to 208. The number of sensor scans performed performed by the intervention group during days 15 to 208.|Days 1 to 208|||number of measurements per day||Standard Deviation|Mean
643617|NCT02232698|Secondary|Time in Range|Difference in time in range 70-180 mg/dL between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15 time in range).|Baseline and Days 194 to 208|1 subject from the standard blood glucose monitoring group had no baseline sensor data and could not be included in the analysis of sensor data.||hours per day||Standard Deviation|Mean
643618|NCT02232698|Secondary|Time Spent >180 mg/dL and >240 mg/dL|Difference in time >180 mg/dL and >240 mg/dL (hours per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).|Baseline and Days 194 to 208|1 subject from the standard blood glucose monitoring group had no baseline sensor data and could not be included in the analysis of sensor data.||hours per day||Standard Deviation|Mean
643619|NCT02232698|Secondary|Frequency of Episodes <70 mg/dL, <55 mg/dL and <40 mg/dL|Difference in frequency of episodes <70 mg/dL, <55 mg/dL and <40 mg/dL (number per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).|Baseline and Days 194-208|1 subject from the standard blood glucose monitoring group had no baseline sensor data and could not be included in the analysis of sensor data.||number of episodes per day||Standard Deviation|Mean
643620|NCT02232698|Secondary|Time Spent <55 mg/dL and <40 mg/dL|Difference in time <55 mg/dL & <40 mg/dL (hours per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).|Baseline and Days 194 to 208|1 subject from the standard blood glucose monitoring group had no baseline sensor data and could not be included in the analysis of sensor data.||hours per day||Standard Deviation|Mean
643621|NCT02232698|Secondary|HbA1c at 6 Months|Difference in HbA1c between intervention and control group at day 208 adjusting for baseline HbA1c at day 1|Baseline and Day 208|||percentage of Glycated Haemoglobin||Standard Deviation|Mean
643622|NCT02232698|Primary|Time Spent <70 mg/dL|Difference in time <70 mg/dL between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).|Baseline and Days 194 to 208|1 subject from the standard blood glucose monitoring group had no baseline sensor data and could not be included in the analysis of sensor data.||hours per day||Standard Deviation|Mean
643624|NCT02232126|Primary|30-day Hospital Readmission|The outcome measure is the number of readmissions experienced by participants in the Usual Care and Intervention groups within 30-days of their index discharge.|30-days post hospitalization|||30-day hospital readmissions|||Number
643627|NCT02231918|Secondary|Number of Patients With Drug Related Adverse Events|Number of patients with adverse events due to study drug.|From first drug administration until 24 hours after last study drug administration, upto 48 days|Safety analysis set: The safety population comprised all patients who provided informed consent and received at least one dose of study drug.||participants|||Number
643628|NCT02231918|Primary|PTF|Peak-trough fluctuation (PTF) is defined as the difference between Cmax and Cmin divided by Cavg and multiplied with 100% at steady-state.|0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.|Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.||% of PTF||Geometric Coefficient of Variation|Geometric Mean
643629|NCT02231918|Primary|CLR,ss|Renal clearance of the analyte at steady state (CLR(0-12),ss ).|12h after last study drug administration on day 1|Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.||mL/min||Geometric Coefficient of Variation|Geometric Mean
643630|NCT02231918|Primary|fe 0-12,ss|Fraction of administered drug excreted unchanged in urine at steady state over a time interval t1 to t2 (fe 0-12,ss ).|12 hours after last study drug administration on day 1.|Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.||% of PPX excreted||Geometric Coefficient of Variation|Geometric Mean
643631|NCT02231918|Primary|Ae 0-12,ss|Amount of analyte that is eliminated in urine at steady state over a time interval t1to t2 (0-12h).|12 hours after last study drug administration on day 1|Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.||ng||Geometric Coefficient of Variation|Geometric Mean
643632|NCT02231918|Primary|Vz/F,ss|Apparent volume of distribution during the terminal phase λz following an extravascular dose at steady state (Vz/F,ss ).|0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.|Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.||L||Geometric Coefficient of Variation|Geometric Mean
643633|NCT02231918|Primary|CL/F,ss|Apparent clearance of the analyte in the plasma after extravascular administration at steady state; F = absolute bioavailability factor (CL/F,ss ).|0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.|Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.||mL/min||Geometric Coefficient of Variation|Geometric Mean
643634|NCT02231918|Primary|MRTpo,ss|Mean residence time of the analyte in the body at steady state (MRTpo,ss).|0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.|Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.||h||Geometric Coefficient of Variation|Geometric Mean
643635|NCT02231918|Primary|t1/2,ss|Terminal half-life of the analyte in plasma at steady state (t1/2,ss ).|0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.|Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.||hours||Geometric Coefficient of Variation|Geometric Mean
643636|NCT02231918|Primary|λz,ss|Terminal rate constant in plasma at steady state (λz,ss ).|0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.|Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.||1/h||Geometric Coefficient of Variation|Geometric Mean
643637|NCT02231918|Primary|AUCτ,ss|Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval (AUCτ,ss ).|0.25h before the drug administration on day 1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on Day 1.|Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
643638|NCT02231918|Primary|Tmin,ss|Time from dosing to minimum concentration at steady state (Tmin,ss ).|0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.|Pharmacokinetic Set (PK): All evaluable subjects who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.||hours||Full Range|Median
643639|NCT02231918|Primary|Tmax,ss|Time from dosing to maximum concentration at steady state (Tmax,ss).|0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.|Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.||hours||Full Range|Median
643640|NCT02231918|Primary|Cavg|Average concentration of the analyte in plasma at steady state (Cavg).|0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.|Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
643641|NCT02231918|Primary|Cpre,N|Predose concentration of the analyte in plasma at steady state immediately before administration of the next dose N (Cpre,N).|0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.|Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
643642|NCT02231918|Primary|Cmin,ss|Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval (Cmin,ss).|0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.|Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.||ng/mL||Standard Deviation|Geometric Mean
643762|NCT02229513|Other Pre-specified|Total Time Uterus Wrapped||During hysterotomy repair|||minutes||Standard Deviation|Mean
643643|NCT02231918|Primary|Cmax,ss|Maximum concentration of the Pramipexole (PPX) in plasma at steady state over a uniform dosing interval (Cmax,ss).|0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.|Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
643644|NCT02231177|Secondary|Clinical Relevant Abnormalities in Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG|Clinically relevant abnormalities in vital signs (blood pressure and pulse rate), physical examination, blood chemistry, haematology, urinanalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events. Any adverse events which occurred within 14 days following the last drug administration were assigned to the last study treatment administered.|From drug administration until 14 days following the last drug administration|Treated Set. All randomised patients who received at least one dose of trial medication were included in the treated set.||participants|||Number
643645|NCT02231177|Secondary|FEV1 Change From Baseline|"Mean change from baseline in forced expiratory volume in one second (FEV1). Pulmonary function test.
The baseline value was measured pre-dose on day 1 of the first treatment period."|0:30 and 1:00 h after drug administration on the first day of each treatment period|Treated Set.||L||Standard Deviation|Mean
643646|NCT02231177|Secondary|FVC Change From Baseline|"Mean change from baseline in forced vital capacity (FVC). Pulmonary function test.
The baseline value was measured pre-dose on day 1 of the first treatment period."|0:30 and 1:00 h after drug administration on the first day of each treatment period|Treated Set.||L||Standard Deviation|Mean
643647|NCT02231177|Secondary|Concentration of Tiotropium in Plasma|"Concentration of the analyte in plasma at 0.333 hours (20 minutes) after the 8th, 14th and 21st dose, C(0.333_8), C(0.333_14,ss) and C(0.333_21,ss) respectively. As steady state was anticipated to be reached by day 14 at the latest, the index 'ss' was used for days 14 and 21.
The displayed values show gMeans and inter-subject variabilities calculated from descriptive statistics."|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.||pg/mL||Geometric Coefficient of Variation|Geometric Mean
643648|NCT02231177|Secondary|Concentration of Olodaterol in Plasma|"Concentration of the analyte in plasma at 0.333 hours (20 minutes) after the 8th, 14th and 21st dose, C(0.333_8), C(0.333_14,ss) and C(0.333_21,ss) respectively. As steady state was anticipated to be reached by day 14 at the latest, the index 'ss' was used for days 14 and 21.
The displayed values show gMeans and inter-subject variabilities calculated from descriptive statistics."|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.||pg/mL||Geometric Coefficient of Variation|Geometric Mean
643649|NCT02231177|Secondary|Tmin,ss of Tiotropium|Time from last dosing to the minimum concentration of the analyte in plasma at steady state over a uniform dosing interval (tmin,ss)|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.||h||Full Range|Median
643650|NCT02231177|Secondary|Tmin,ss of Olodaterol|Time from last dosing to the minimum concentration of the analyte in plasma at steady state over a uniform dosing interval (tmin,ss)|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.||h||Full Range|Median
643651|NCT02231177|Secondary|Cmin,ss of Tiotropium|"Minimum concentration of the analyte in plasma at steady state over a uniform dosing interval (Cmin,ss).
The displayed values show gMeans and inter-subject variabilities calculated from descriptive statistics."|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.||pg/mL||Geometric Coefficient of Variation|Geometric Mean
643652|NCT02231177|Secondary|Cmin,ss of Olodaterol|"Minimum concentration of the analyte in plasma at steady state over a uniform dosing interval (Cmin,ss).
The displayed values show gMeans and inter-subject variabilities calculated from descriptive statistics."|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.||pg/mL||Geometric Coefficient of Variation|Geometric Mean
643653|NCT02231177|Secondary|fe(0-24,ss) of Tiotropium|"Fraction of Tiotropium eliminated in urine from 0 to 24 hours at steady state (fe(0-24,ss)).
The displayed values show gMeans and inter-subject variabilities calculated from descriptive statistics."|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.||percentage of tiotropium dose||Geometric Coefficient of Variation|Geometric Mean
643654|NCT02231177|Secondary|fe(0-24,ss) of Olodaterol|"Fraction of Olodaterol eliminated in urine from 0 to 24 hours at steady state (fe(0-24,ss)).
The displayed values show gMeans and inter-subject variabilities calculated from descriptive statistics."|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.||percentage of olodaterol dose||Geometric Coefficient of Variation|Geometric Mean
643655|NCT02231177|Secondary|Tmax,ss of Tiotropium|Time from dosing to the maximum concentration of Tiotropium in plasma at steady state (tmax,ss).|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.||h||Full Range|Median
643656|NCT02231177|Secondary|Tmax,ss of Olodaterol|Time from dosing to the maximum concentration of Olodaterol in plasma at steady state (tmax,ss).|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.||h||Full Range|Median
643657|NCT02231177|Secondary|AUC(0-tz,ss) of Tiotropium|"Area under the plasma concentration-time curve at steady state over the time interval from 0 to the time of the last quantifiable data point (AUC(0-tz)) for Tiotropium.
The displayed values show adjusted gMeans and intra-subject variabilities calculated from the statistical model (ANOVA)."|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
643658|NCT02231177|Secondary|AUC(0-tz,ss) of Olodaterol|"Area under the plasma concentration-time curve at steady state over the time interval from 0 to the time of the last quantifiable data point (AUC(0-tz)) for Olodaterol.
The displayed values show adjusted gMeans and intra-subject variabilities calculated from the statistical model (ANOVA)."|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
643659|NCT02231177|Secondary|AUC(0-4h,ss) of Tiotropium|"Area under the concentration time curve of Tiotropium in plasma over the time interval t1=0 to t2=4 h at steady state (AUC(0-4h,ss)).
The displayed values show adjusted gMeans and intra-subject variabilities calculated from the statistical model (ANOVA)."|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
643660|NCT02231177|Secondary|AUC(0-2h,ss) of Olodaterol|"Area under the concentration time curve of Olodaterol in plasma over the time interval 0 to 2 hours at steady state (AUC(0-2h,ss)).
The displayed values show adjusted gMeans and intra-subject variabilities calculated from the statistical model (ANOVA)."|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
643661|NCT02231177|Secondary|Cmax,ss of Tiotropium|"Maximum measured concentration of Tiotropium in plasma at steady state (Cmax,ss).
The displayed values show adjusted gMeans and intra-subject variabilities calculated from the statistical model (ANOVA)."|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.||pg/mL||Geometric Coefficient of Variation|Geometric Mean
643662|NCT02231177|Secondary|AUC(0-6h,ss) of Tiotropium|"Area under the concentration time curve of Tiotropium in plasma over the time interval t1=0 to t2=6 h at steady state (AUC(0-6h,ss)).
As plasma concentrations were not expected to be quantifiable over the complete dosing interval in all patients, t2 was defined as the time-point where at least 2/3 of the patients reveal quantifiable plasma concentrations of Tiotropium. Based on the given definition AUC(0-6h,ss) was selected as secondary endpoint.
The displayed values show adjusted gMeans and intra-subject variabilities calculated from the statistical model (ANOVA)."|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
643663|NCT02231177|Secondary|Ae(0-24h,ss) of Olodaterol|"Amount of Olodaterol that was eliminated in urine at steady state from time point 0 to 24 h post-inhalation (Ae(0-24h,ss)).
The displayed values show adjusted gMeans and intra-subject variabilities calculated from the statistical model (ANOVA)."|Intervals 0-4, 4-8, 8-12 and 12-24 hours on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.||ng||Geometric Coefficient of Variation|Geometric Mean
643664|NCT02231177|Primary|Ae(0-24h,ss) of Tiotropium|"Amount of Tiotropium that was eliminated in urine at steady state from time point 0 to 24 h post-inhalation (Ae(0-24h,ss)).
The displayed values show adjusted gMeans and intra-subject variabilities calculated from the statistical model (ANOVA)."|Intervals 0-4, 4-8, 8-12 and 12-24 hours on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.||ng||Geometric Coefficient of Variation|Geometric Mean
643665|NCT02231177|Primary|Cmax,ss of Olodaterol|"Maximum measured concentration of Olodaterol in plasma at steady state (Cmax,ss).
The displayed values show adjusted gMeans and intra-subject variabilities calculated from the statistical model (ANOVA)."|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.||pg/mL||Geometric Coefficient of Variation|Geometric Mean
643666|NCT02231177|Primary|AUC(0-1h,ss) of Olodaterol|"Area under the concentration time curve of Olodaterol in plasma over the time interval t1=0 to t2=1 hour at steady state (AUC(0-1h,ss)).
As plasma concentrations were not expected to be quantifiable over the complete dosing interval in all patients, t2 was defined as the time-point where at least 2/3 of the patients reveal quantifiable plasma concentrations of Olodaterol. Based on the given definition AUC(0-1h,ss) was selected as primary endpoint.
The displayed values show adjusted gMeans and intra-subject variabilities calculated from the statistical model (ANOVA)."|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic (PK) set which included all patients in the treated set who provided at least one of the PK parameters in at least one treatment period and completed the trial without any important protocol violations, it is however restricted to patients with evaluable data for this endpoint.||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
643667|NCT02231164|Primary|Disease Control According to Response Evaluation Criteria in Solid Tumours (RECIST), Version 1.1|This outcome measure presents the number of patients with disease control according to RECIST, version 1.1, defined as number of patients with Complete response, partial response or stable disease.|Up to 6 months.|Randomised Set: The randomised set included all randomised patients.||Percentage of participants|||Number
643668|NCT02230995|Secondary|AUC0-infinity of Metformin in Plasma|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity.|-1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration|PKS set||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
643669|NCT02230995|Secondary|AUC0-infinity of Empagliflozin in Plasma|Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity)|-1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration|PKS set||nmol·h/L||Geometric Coefficient of Variation|Geometric Mean
643670|NCT02230995|Primary|Cmax of Metformin in Plasma|Maximum measured concentration of the metformin in plasma|-1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration|PKS set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
643671|NCT02230995|Primary|Cmax of Empagliflozin in Plasma|Maximum measured concentration of empagliflozin in plasma (Cmax)|-1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration|PKS set||nmol/L||Geometric Coefficient of Variation|Geometric Mean
643672|NCT02230995|Primary|AUC0-tz of Metformin in Plasma|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable concentration|-1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration|Pharmacokinetic Set (PKS): This analysis set included all treated subjects that provided at least 1 observation for at least 1 primary endpoint without important protocol violations with respect to the statistical evaluation of the pharmacokinetic endpoints.||ng·h/mL||Geometric Coefficient of Variation|Geometric Mean
643673|NCT02230995|Primary|AUC0-tz of Empagliflozin in Plasma|Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 to the time of the last quantifiable concentration (AUC0-tz)|-1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration|PKS set||nmol·h/L||Geometric Coefficient of Variation|Geometric Mean
643674|NCT02230956|Secondary|Change From Baseline in the 7-Day Average Daily Worst Pain Score Using an 11-Point Scale|Participants recorded the pain in their knee during the previous 24 hours in a daily diary where: 0=no pain to 10= worst pain possible. The daily worst pain scores over 7-days were averaged. A negative change from Baseline indicates improvement.|Baseline, Week 24|Safety population consisted of all randomized participants who received the study treatment and were analyzed by treatment actually received.||score on a scale||Standard Deviation|Mean
643675|NCT02230956|Secondary|Patient Global Impression of Change (GIC) Using a 7-Point Scale|The participant rated the change in their health status since enrollment using a 7-point scale where: +3=very much improved, +2=much improved, +1=minimally improved, 0=no change, -1=minimally worse, -2=much worse and -3=very much worse. Negative scores indicate worsening and positive scores indicate improvement.|Weeks 1, 4, 8, 12, 16, 20 and 24|"Safety population consisted of all randomized participants who received the study treatment and were analyzed by treatment actually received. n in the category is the number of participants with data available at the given time-point."||score on a scale||Standard Deviation|Mean
643676|NCT02230956|Secondary|Change From Baseline in the WOMAC™ Physical Function Score Using an 11-Point Scale|The WOMAC Physical Function Score consisted of 17 questions about the difficulty of daily activities completed by the participant where: 0=no difficulty to 10=extreme difficulty for a total possible Physical Function Score of 0 (best) to 170 (worst). A negative change from Baseline indicates improvement.|Baseline, Weeks 1, 4, 8, 12, 16, 20 and 24|"Safety population consisted of all randomized participants who received the study treatment and were analyzed by treatment actually received. n in the category is the number of participants with data available at the given time-point."||score on a scale||Standard Deviation|Mean
643677|NCT02230956|Secondary|Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC™) Pain Score Using an 11-Point Scale|The WOMAC Pain Score consisted of 5 questions about pain completed by the participant where: 0=no pain to 10=extreme pain for a total possible Pain Score of 0 (best) to 50 (worst). A negative change from Baseline indicates improvement.|Baseline, Weeks 1, 4, 8, 12, 16, 20 and 24|"Safety population consisted of all randomized participants who received the study treatment and were analyzed by treatment actually received. n in the category is the number of participants with data available at the given time-point."||score on a scale||Standard Deviation|Mean
643678|NCT02230956|Primary|Change From Baseline in the 7-Day Average Daily Pain Score Using an 11-Point Scale|Participants recorded the pain in their knee during the previous 24 hours in a daily diary where: 0=no pain to 10= worst pain possible. The daily pain scores over 7-days were averaged. A negative change from Baseline indicates improvement.|Baseline, Week 8|Safety population consisted of all randomized participants who received the study treatment and were analyzed by treatment actually received.||score on a scale||Standard Deviation|Mean
643700|NCT02230085|Primary|CPAP Therapy Adherence|Adherence is measured by the amount of CPAP use (e.g. good adherence was defined as use of greater than or equal to 70% of nights for greater than 4 hours per night). CPAP data was remotely collected and analyzed from the data reports generated by data collection.|90 days|103 patients CPAP therapy adherence data was collected. 3 patients data was either lost or unable to be downloaded.||participants|||Number
643730|NCT02229864|Secondary|Number of Subjects With All Death|All death includes cardiac death, vascular death, and non-cardiac death.|≤ 7 days post index procedure (In-hospital )|||Participants|||Count of Participants
643763|NCT02229513|Other Pre-specified|Patient Temperature||Pre-op, Intra-op, Post-Op|||degrees Fahrenheit||Standard Deviation|Mean
643764|NCT02229513|Secondary|Use of Extra Oxytocin||Intraoperatively|||participants|||Number
643679|NCT02230904|Secondary|Change in Average Patch Adhesiveness Score of 2 Days of 24 Hour Patch Application as Rated by the Investigator (or Designee), Assessed According to the FDA/Center for Drug Evaluation and Research (CDER) Score|"The assessment was performed according to the adhesion score adapted from the EMA draft guideline on quality of transdermal patches . Afterwards, EMA scores were translated into FDA/CDER scores:
0 (>95-100% of patch adheres) >> 0 (FDA/CDER)
1 (>90-95% of patch adheres) >> 0 (FDA/CDER)
2 (>85-90% of patch adheres) >> 1 (FDA/CDER)
3 (>80-85% of patch adheres) >> 1 (FDA/CDER)
4 ( >75-80% of patch adheres) >> 1 (FDA/CDER)
5 (>70-75% of patch adheres) >> 2 (FDA/CDER)
6 (≥50-70% of patch adheres) >> 2 (FDA/CDER)
7 (<50 % of patch adheres) >> 3 (FDA/CDER)
8 (Patch completely detached) >> 4 (FDA/CDER)
Due to a slight mismatch of limits between FDA scores 0 and 1 as compared to EMA scores 1 and 2, the theoretical value of exactly 90 % of adh. fell into score 1 with the FDA scoring. A similar limit mismatch occured at exactly 75 %. These mismatches may have resulted in a slightly worse estimation of the adh. with the FDA score as compared to previous adh. studies."|Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2, 3, 4 and 5|Per Protocol Set (PPS), which was defined as all subjects who had at least 1 patch adhesiveness assessment after 24 hours of patch application by the investigator (or designee) for both treatments.||units on a scale||Standard Deviation|Mean
643680|NCT02230904|Secondary|Patch Adhesiveness Per Day as Rated by the Subject 24 Hours After Patch Application for Patch 2|"The subject assessed the patch adhesiveness by using the following score:
0 = Satisfied with adhesiveness
1 = Moderately satisfied with adhesiveness
2 = Moderately unsatisfied with adhesiveness
3 = Unsatisfied with adhesiveness"|Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 3 and 5|Per Protocol Set (PPS), which was defined as all subjects who had at least 1 patch adhesiveness assessment after 24 hours of patch application by the investigator (or designee) for both treatments.||percentage of patches|Participants||Number
643681|NCT02230904|Secondary|Patch Adhesiveness Per Day as Rated by the Subject 24 Hours After Patch Application for Patch 1|"The subject assessed the patch adhesiveness by using the following score:
0 = Satisfied with adhesiveness
1 = Moderately satisfied with adhesiveness
2 = Moderately unsatisfied with adhesiveness
3 = Unsatisfied with adhesiveness"|Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2 and 4|Per Protocol Set (PPS), which was defined as all subjects who had at least 1 patch adhesiveness assessment after 24 hours of patch application by the investigator (or designee) for both treatments.||percentage of patches|Participants||Number
643682|NCT02230904|Secondary|Patch Adhesiveness Per Day as Rated by the Investigator 24 Hours After Patch Application According to the FDA/Center for Drug Evaluation and Research (CDER) Score for Patch 2|"The assessment was performed according to the adhesion score adapted from the EMA draft guideline on quality of transdermal patches . Afterwards, EMA scores were translated into FDA/CDER scores:
0 (>95-100% of patch adheres) >> 0 (FDA/CDER)
1 (>90-95% of patch adheres) >> 0 (FDA/CDER)
2 (>85-90% of patch adheres) >> 1 (FDA/CDER)
3 (>80-85% of patch adheres) >> 1 (FDA/CDER)
4 ( >75-80% of patch adheres) >> 1 (FDA/CDER)
5 (>70-75% of patch adheres) >> 2 (FDA/CDER)
6 (≥50-70% of patch adheres) >> 2 (FDA/CDER)
7 (<50 % of patch adheres) >> 3 (FDA/CDER)
8 (Patch completely detached) >> 4 (FDA/CDER)
Due to a slight mismatch of limits between FDA scores 0 and 1 as compared to EMA scores 1 and 2, the theoretical value of exactly 90 % of adh. fell into score 1 with the FDA scoring. A similar limit mismatch occured at exactly 75 %. These mismatches may have resulted in a slightly worse estimation of the adh. with the FDA score as compared to previous adh. studies."|Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 3 and 5|Per Protocol Set (PPS), which was defined as all subjects who had at least 1 patch adhesiveness assessment after 24 hours of patch application by the investigator (or designee) for both treatments.||percentage of patches|Participants||Number
643683|NCT02230904|Secondary|Patch Adhesiveness Per Day as Rated by the Investigator 24 Hours After Patch Application According to the FDA/Center for Drug Evaluation and Research (CDER) Score for Patch 1|"The assessment was performed according to the adhesion score adapted from the EMA draft guideline on quality of transdermal patches . Afterwards, EMA scores were translated into FDA/CDER scores:
0 (>95-100% of patch adheres) >> 0 (FDA/CDER)
1 (>90-95% of patch adheres) >> 0 (FDA/CDER)
2 (>85-90% of patch adheres) >> 1 (FDA/CDER)
3 (>80-85% of patch adheres) >> 1 (FDA/CDER)
4 ( >75-80% of patch adheres) >> 1 (FDA/CDER)
5 (>70-75% of patch adheres) >> 2 (FDA/CDER)
6 (≥50-70% of patch adheres) >> 2 (FDA/CDER)
7 (<50 % of patch adheres) >> 3 (FDA/CDER)
8 (Patch completely detached) >> 4 (FDA/CDER)
Due to a slight mismatch of limits between FDA scores 0 and 1 as compared to EMA scores 1 and 2, the theoretical value of exactly 90 % of adh. fell into score 1 with the FDA scoring. A similar limit mismatch occured at exactly 75 %. These mismatches may have resulted in a slightly worse estimation of the adh. with the FDA score as compared to previous adh. studies."|Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2 and 4|Per Protocol Set (PPS), which was defined as all subjects who had at least 1 patch adhesiveness assessment after 24 hours of patch application by the investigator (or designee) for both treatments.||percentage of patches|Participants||Number
643684|NCT02230904|Secondary|Patch Adhesiveness Per Day as Rated by the Investigator 24 Hours After Patch Application According to the EMA Draft Guideline for Patch 2|"The assessment was performed according to the adhesion score adapted from the EMA draft guideline on quality of transdermal patches (EMA/CHMMP/QWP/911254/2011, 2012).
0 = >95 - 100 % of the patch area adheres
1 = >90 - 95 % of the patch adheres
2 = >85 - 90 % of the patch adheres
3 = >80 - 85 % of the patch adheres
4 = >75 - 80 % of the patch adheres
5 = >70 - 75 % of the patch adheres
6 = ≥50 - 70 % of the patch adheres
7 = <50 % of the patch adheres
8 = Patch completely detached
The recorded scores 6, 7, and 8 were combined in order to create a cumulative group “less than or equal to 70 % adhered or patch detachment” which was regarded as significant patch adhesion failure in the draft EMA guideline."|Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 3 and 5|Per Protocol Set (PPS), which was defined as all subjects who had at least 1 patch adhesiveness assessment after 24 hours of patch application by the investigator (or designee) for both treatments.||percentage of patches|Participants||Number
643719|NCT02229864|Secondary|Number of Subjects With All Target Lesion Revascularization (TLR)|All target lesion revascularization includes ischemia-driven target lesion revascularization (ID-TLR) and non ischemia-driven target lesion revascularization (NID-TLR).|0 to 37 Days|||Participants|||Count of Participants
643731|NCT02229864|Secondary|Number of Subjects With Target Lesion Failure (Cardiac Death, TVMI, TLR)|Target Lesion Failure (TLF) includes Cardiac Death, Target vessel - myocardial infarction and Target Lesion Revascularization (TLR).|0 to 758 Days|||Participants|||Count of Participants
643685|NCT02230904|Secondary|Patch Adhesiveness Per Day as Rated by the Investigator or Designee 24 Hours After Patch Application According to the EMA Draft Guideline for Patch 1|"The assessment was performed according to the adhesion score adapted from the EMA draft guideline on quality of transdermal patches (EMA/CHMMP/QWP/911254/2011, 2012).
0 = >95 - 100 % of the patch area adheres
1 = >90 - 95 % of the patch adheres
2 = >85 - 90 % of the patch adheres
3 = >80 - 85 % of the patch adheres
4 = >75 - 80 % of the patch adheres
5 = >70 - 75 % of the patch adheres
6 = ≥50 - 70 % of the patch adheres
7 = <50 % of the patch adheres
8 = Patch completely detached
The recorded scores 6, 7, and 8 were combined in order to create a cumulative group “less than or equal to 70 % adhered or patch detachment” which was regarded as significant patch adhesion failure in the draft EMA guideline."|Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2 and 4|Per Protocol Set (PPS), which was defined as all subjects who had at least 1 patch adhesiveness assessment after 24 hours of patch application by the investigator (or designee) for both treatments.||percentage of patches|Participants||Number
643686|NCT02230904|Primary|Change in Average Adhesiveness Score of 2 Days of 24 Hours Patch Application as Rated by the Investigator (or Designee) Assessed According to the EMA Draft Guideline|"The assessment was performed according to the adhesion score adapted from the EMA draft guideline on quality of transdermal patches (EMA/CHMMP/QWP/911254/2011, 2012).
0 = > 95 - 100 % of the patch area adheres
1 = > 90 - 95 % of the patch adheres
2 = > 85 - 90 % of the patch adheres
3 = > 80 - 85 % of the patch adheres
4 = > 75 - 80 % of the patch adheres
5 = > 70 - 75 % of the patch adheres
6 = ≥ 50 - 70 % of the patch adheres
7 = < 50 % of the patch adheres
8 = Patch completely detached
The recorded scores 6, 7, and 8 were combined in order to create a cumulative group less than or equal to 70 % adhered or patch detachment which was regarded as significant patch adhesion failure in the draft EMA guideline.
The average of patches 1 and 2 is presented by Treatment Arm below."|Patch adhesiveness was measured after 24 hours (±1 hour) after previous patch application on Day 2, 3, 4 and 5|Per Protocol Set (PPS), which was defined as all subjects who had at least 1 patch adhesiveness assessment after 24 hours of patch application by the investigator (or designee) for both treatments.||units on a scale||Standard Deviation|Mean
643687|NCT02230761|Other Pre-specified|Patient Satisfaction Scale 2 (PSS2)|Composite score on PSS2 scale. PSS2 is an ordinal scale with range 1-7, where 1 is least favorable and 7 is most favorable. The composite score is the sum of 3 items and has a possible response range of 3 to 21.|11 weeks|intention-to-treat||units on a scale||Standard Deviation|Mean
643688|NCT02230761|Other Pre-specified|Patient Satisfaction Scale 1 (PSS1)|Change from Baseline to Week 11 in PSS1 score. PSS1 scale items use an ordinal scale with range 0-10, where 0 is the least favorable and 10 is the most favorable. The composite score is the sum of 6 items and has a possible response range of 0 to 60.|0-11 weeks|intention-to-treat||units on a scale||Standard Deviation|Mean
643689|NCT02230761|Primary|Lower Eyelid Steatoblepharon Severity (LESS) Score--Clinician-Reported|Photonumeric scale, range 0-4, 0 is absence of steatoblepharon, 4 is very severe steatoblepharon.|11 weeks|intention-to-treat||participants|||Number
643690|NCT02230683|Secondary|Concentration of Caspase 3/7 RLU|Median change of concentration of Caspase 3/7 Relative Light Units from Baseline to Day 28/EOT (end of treatment) for IDN-6556|Baseline to 28 days/EOT|||RLU||Full Range|Median
643691|NCT02230683|Secondary|Change in Aspartate Aminotransferase (AST)|Median change of AST from Baseline to Day 28/EOT (end of treatment) for IDN-6556|Baseline to 28 days/EOT|||U/L||Full Range|Median
643692|NCT02230683|Secondary|Change in Alanine Aminotransferase (ALT)|Median change of ALT from Baseline to Day 28/EOT (end of treatment) for IDN-6556|Baseline to 28 days/EOT|||U/L||Full Range|Median
643693|NCT02230683|Primary|Change in cCK18/M30|Median change of caspase-cleaved cytokeratin serum levels (cCK18/M30) from Baseline to Day 28/EOT (end of treatment) for IDN-6556|Baseline to Day 28/EOT (end of treatment)|||U/L||Full Range|Median
643694|NCT02230683|Primary|cCK18/M30|Absolute Mean Change of caspase-cleaved cytokeratin serum levels (cCK18/M30); the statistical analysis is based on the mean change in log-transformed cCK18/M30 from Baseline to Day 28/EOT (end of treatment) for IDN-6556|Change from Baseline to Day 28/EOT|||U/L||Standard Deviation|Mean
643695|NCT02230683|Primary|Hepatic Venous Pressure Gradient (HVPG)|Mean change of HVPG [mmHg] from Baseline to Day 28/EOT (end of treatment) for IDN-6556|Baseline to Day 28/EOT (end of treatment)|23 subjects were enrolled, of whom 22 were evaluable for the HVPG endpoint. 1 subject discontinued at day 1.||mmHg||Standard Deviation|Mean
643696|NCT02230670|Secondary|Change From Baseline to Month 3 in MELD Score|"The Model for End-Stage Liver Disease (MELD) is a scoring system for assessing the severity of chronic liver disease and uses the subject's values for total bilirubin, serum creatinine, and the international normalized ratio (INR) for prothrombin time to predict survival. MELD is calculated according to the following formula:
MELD = 3.78×ln[serum bilirubin (mg/dL)] + 11.2×ln[INR] + 9.57×ln[serum creatinine (mg/dL)] + 6.43
MELD scores are reported as whole numbers, so the result of the equation above is rounded. Notes: If the patient has been dialyzed twice within the last 7 days, then the value for serum creatinine used should be 4.0. Any value less than one is given a value of 1 (i.e. if bilirubin is 0.8, a value of 1.0 is used) to prevent the occurrence of scores below 0 (the natural logarithm of 1 is 0, and any value below 1 would yield a negative result). The higher the MELD score the more severe the disease state."|3 Months|FAS||units on a scale||Standard Error|Least Squares Mean
643697|NCT02230670|Primary|Change From Baseline at Month 3 in cCK18/M30|Data was log-transformed for analysis purposes|3 months|Full analysis set||U/L||Standard Error|Least Squares Mean
643698|NCT02230670|Primary|Change From Baseline at Month 3 in cCK18/M30|Baseline, Month 3, and change between for cCK18/M30|3 months|FAS||U/L||Full Range|Median
643699|NCT02230540|Primary|Residual Volume Less Than 100ml|"The primary endpoint was “Residual volume less than 100 ml (Yes/No)” assessed after catheterization when placed at fixed heights (25, 20, 15, 10 and 0 cm) over the wheelchair seat.
Prior to the catheterization corresponding to height 25 cm, a solution was instilled into the bladder to ensure a volume equal to 300 ml. The residual volume at height 25 cm was then calculated as 300 ml minus the volume emptied during catheterization. The residual volume corresponding to height 20 cm was calculated as the residual volume corresponding to height 25 minus the additional volume emptied at height 20. The residual volume corresponding to height 15, 10 and 0 cm were derived similarly.
Calculated residual volumes were negative, likely due to faulty ultrasound scans performed on subjects in sitting position. Consequently, the changes in bladder volumes, re-worded from “300ml – collected volume <100ml” to “collected volume > 200ml”, were used to interpret the primary endpoint."|2-4 hours|||Subjects with successful catheterization|||Number
643701|NCT02229864|Secondary|Number of Subjects With Cumulative Stent/Scaffold Thrombosis (Definite/Probable)|"Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.
Timings:
Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation"|0 to 758 days|||Participants|||Count of Participants
643702|NCT02229864|Secondary|Number of Subjects With Cumulative Stent/Scaffold Thrombosis (Definite/Probable)|"Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.
Timings:
Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation"|0 to 393 days|||Participants|||Count of Participants
643703|NCT02229864|Secondary|Number of Subjects With Late Stent/Scaffold Thrombosis (Definite/Probable)|"Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.
Timings:
Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation"|31 to 393 days|||Participants|||Count of Participants
643704|NCT02229864|Secondary|Number of Subjects With Subacute Stent/Scaffold Thrombosis (Definite/Probable)|"Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.
Timings:
Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation"|>1 to 30 days|||Participants|||Count of Participants
643705|NCT02229864|Secondary|Number of Subjects With Acute Stent/Scaffold Thrombosis (Definite/Probable)|"Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.
Timings:
Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation"|≤ 1 day|||Participants|||Count of Participants
643706|NCT02229864|Secondary|Number of Subjects With All Revascularization|All revascularization includes ischemia driven revascularization and non ischemia driven revascularization.|0 to 758 Days|||Participants|||Count of Participants
643707|NCT02229864|Secondary|Number of Subjects With All Revascularization|All revascularization includes ischemia driven revascularization and non ischemia driven revascularization.|0 to 393 Days|||Participants|||Count of Participants
643708|NCT02229864|Secondary|Number of Subjects With All Revascularization|All revascularization includes ischemia driven revascularization and non ischemia driven revascularization.|0 to 208 Days|||Participants|||Count of Participants
643709|NCT02229864|Secondary|Number of Subjects With All Revascularization|All revascularization includes ischemia driven revascularization and non ischemia driven revascularization.|0 to 37 Days|||Participants|||Count of Participants
643710|NCT02229864|Secondary|Number of Subjects With All Revascularization|All revascularization includes ischemia driven revascularization and non ischemia driven revascularization.|≤ 7 days post index procedure (In-hospital )|||Participants|||Count of Participants
643711|NCT02229864|Secondary|Number of Subjects With All Target Vessel Revascularization (TVR)|All target vessel revascularization includes ischemia driven target vessel revascularization (ID-TVR) and non ischemia driven target vessel revascularization (NID-TVR).|0 to 758 Days|||Participants|||Count of Participants
643712|NCT02229864|Secondary|Number of Subjects With All Target Vessel Revascularization (TVR)|All target vessel revascularization includes ischemia driven target vessel revascularization (ID-TVR) and non ischemia driven target vessel revascularization (NID-TVR).|0 to 393 Days|||Participants|||Count of Participants
643713|NCT02229864|Secondary|Number of Subjects With All Target Vessel Revascularization (TVR)|All target vessel revascularization includes ischemia driven target vessel revascularization (ID-TVR) and non ischemia driven target vessel revascularization (NID-TVR).|0 to 208 Days|||Participants|||Count of Participants
643714|NCT02229864|Secondary|Number of Subjects With All Target Vessel Revascularization (TVR)|All target vessel revascularization includes ischemia driven target vessel revascularization (ID-TVR) and non ischemia driven target vessel revascularization (NID-TVR).|0 to 37 Days|||Participants|||Count of Participants
643715|NCT02229864|Secondary|Number of Subjects With All Target Vessel Revascularization (TVR)|All target vessel revascularization includes ischemia driven target vessel revascularization (ID-TVR) and non ischemia driven target vessel revascularization (NID-TVR).|≤ 7 days post index procedure (In-hospital )|||Participants|||Count of Participants
643716|NCT02229864|Secondary|Number of Subjects With All Target Lesion Revascularization (TLR)|All target lesion revascularization includes ischemia-driven target lesion revascularization (ID-TLR) and non ischemia-driven target lesion revascularization (NID-TLR).|0 to 758 Days|||Participants|||Count of Participants
643717|NCT02229864|Secondary|Number of Subjects With All Target Lesion Revascularization (TLR)|All target lesion revascularization includes ischemia-driven target lesion revascularization (ID-TLR) and non ischemia-driven target lesion revascularization (NID-TLR).|0 to 393 Days|||Participants|||Count of Participants
643718|NCT02229864|Secondary|Number of Subjects With All Target Lesion Revascularization (TLR)|All target lesion revascularization includes ischemia-driven target lesion revascularization (ID-TLR) and non ischemia-driven target lesion revascularization (NID-TLR).|0 to 208 Days|||Participants|||Count of Participants
643734|NCT02229864|Secondary|Number of Subjects With Target Lesion Failure (Cardiac Death, TVMI, TLR)|Target Lesion Failure (TLF) includes Cardiac Death, Target vessel - myocardial infarction and Target Lesion Revascularization (TLR).|0 to 37 days|||Participants|||Count of Participants
643735|NCT02229864|Secondary|Number of Subjects With Target Lesion Failure (Cardiac Death, TVMI, TLR)|Target Lesion Failure (TLF) includes Cardiac Death, Target vessel - myocardial infarction and Target Lesion Revascularization (TLR).|≤ 7 days post index procedure (In-hospital )|||Participants|||Count of Participants
643736|NCT02229864|Primary|Drug Clearance (CL)|"The systemic drug clearance, reached during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation).
Calculated as: CL = Dose/AUC0 - ∞ ."|0 to 30 days|||Liter/hour||Full Range|Median
643737|NCT02229864|Primary|Terminal Elimination Half-life (t1/2term)|"The apparent terminal elimination half-life, reached during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation).
calculated as: t1/2term = 0.693/λz."|0 to 30 days|||Hours||Full Range|Median
643738|NCT02229864|Primary|Terminal Elimination Rate Constant (λz)|The apparent terminal elimination rate constant during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation). Determined by linear regression of terminal points of the ln-linear analyte concentration-time curve.|0 to 30 days|||1/hour||Full Range|Median
643739|NCT02229864|Primary|AUC 0-infinity|"AUC 0-infinity: Area under the blood analyte concentration vs. time curve from time zero and extrapolated to infinite time, reached during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation).
calculated as: AUC0-∞ = AUClast + (Clast/λz)
The percentage of AUC0-∞ obtained by extrapolation (%AUC0-∞ex) is calculated as:
%AUC0-∞ex = (AUC0-∞ – AUClast)/ AUC0-∞ * 100"|0 to 30 days|||ng*h/mL||Full Range|Median
643740|NCT02229864|Primary|AUC Last|Area under the blood analyte concentration vs. time curve from time 0 up to the last quantifiable concentration reached during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation). Calculated by the Lin Up Log Down trapezoidal method.|0 to 30 days|||ng*h/mL||Full Range|Median
643741|NCT02229864|Primary|AUC24h|Area under the blood analyte concentration vs. time curve from time 0 up to 24 hours post placement of the last Absorb BVS. Calculated by the Lin Up Log Down trapezoidal method.|0 to 24 hours|||ng*h/mL||Full Range|Median
643742|NCT02229864|Primary|Time of Maximum (Tmax)|Time to reach the maximal observed blood analyte concentration during the 30 day period of the study after assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation).|0 to 30 days|||Hours||Full Range|Median
643743|NCT02229864|Primary|Maximum Concentration (Cmax)|Maximal observed blood analyte concentration. Cmax is the highest blood everolimus concentration reached during the 30 day period of the study after assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation).|0 to 30 days|||nanograms per milliliter||Full Range|Median
643744|NCT02229539|Secondary|Alternative Analgesics Use in the Continuation Phase||Up to 4 hours post-treatment||||||
643745|NCT02229539|Secondary|Pain Score in the Continuation Phase||Up to 4 hours post-treatment||||||
643746|NCT02229539|Secondary|The Length of Time in the Continuation Phase||Up to 4 hours post-treatment||||||
643747|NCT02229539|Secondary|Patient Preference for Continued Therapy With Oral Rinse After Initial Test Rinse Phase, as Measured by Item 9 in the Patient-reported Questionnaire After 4 Hours||Up to 4 hours post-treatment||||||
643748|NCT02229539|Secondary|The Incidence of Using Alternative Analgesics Between 1 and 4 Hours After Initial Mouthwash||Up to 4 hours post-treatment||||||
643749|NCT02229539|Secondary|The Total Drowsiness Increase as Measured by the Numerical Analogue Scale of Drowsiness Questionnaires||Up to 4 hours post-treatment every 4 hours while on treatment||||||
643750|NCT02229539|Secondary|The Total Stinging or Burning From the Oral Rinse as Measured by the Numerical Analogue Scale of Stinging or Burning From the Oral Rinse in the Questionnaires||Up to 4 hours post-treatment||||||
643751|NCT02229539|Secondary|The Total Unpleasant Taste of the Oral Rinse as Measured by the Numerical Analogue Scale of Taste of the Oral Rinse in the Questionnaires||Up to 4 hours post-treatment||||||
643752|NCT02229539|Primary|Mean Area Under the Curve (AUC) of Total Pain Reduction|Total pain reduction (mouth and throat) was measured by the numerical analogue scale of mouth pain on a scale of 0 to 10, with 0=no pain and 10=worst pain in the questionnaires taken at baseline, and 5, 15, 30, 60, 120, 240 minutes after assigned treatment for doxepin or DLA vs. placebo. The total pain reduction was calculated by the (average of mouth and throat) area under the curve (AUC) adjusting for baseline, with time scale (baseline, 5, 15, 30, 60, 120 and 240 minutes post treatment) replaced by a numerical scale of 0, 1, 2, 3, 4, 5 and 6 respectively. The AUC was prorated when there are terminal missing data. If the missing data were intermittent, simple imputation by trapezoidal rules were applied to calculate the AUC. If a patient cancelled, was missing baseline data, or only provided baseline data, he/she was excluded from the statistical analysis.|Baseline, 5, 15, 30, 60, 120, 240 minutes post treatment|All participants who met eligibility criteria, had mouth pain score of at least 4 on 0 to 10 scale with higher scores indicated worst pain and started the treatment and had mouth and throat pain data at baseline and at least one time point beyond baseline.||units on a scale*time scale||Standard Deviation|Mean
643753|NCT02229513|Secondary|Requirement of Cesarean Hysterectomy||During surgery and in the PACU (approximately 3 total hours)|||participants|||Number
643754|NCT02229513|Secondary|Total Blood Loss Greater Than 1000 cc||Intra-op, Post-Op|||participants|||Number
643755|NCT02229513|Secondary|Requirement of Blood Products||During surgery and in the PACU (approximately 3 total hours)|||participants|||Number
643756|NCT02229513|Secondary|Use of Additional Measures to Control Blood Loss, Including Pharmacological and Surgical Interventions||Intraoperatively|||participants|||Number
643767|NCT02229513|Primary|Blood Loss|At the conclusion of the surgery, blood loss will be calculated by measuring the content of blood in the suction canister, and by weighing the surgical sponges. The amount of blood loss in the PACU will be measured by weighing pads.|During surgery and in the PACU (approximately 3 total hours)|||cc||Standard Deviation|Mean
643769|NCT02229461|Secondary|Inhibition of TXB2 Using Platelet-rich Plasma (PRP) on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration|Inhibition of plasma TXB2 at each time point were calculated using the percentage of reduction from baseline as follows: Inhibition (%) = 100 × (Baseline Value – Post-baseline Value) / Baseline Value. For primary analysis, the mean and the lower bound of the corresponding one-sided 95% CI were calculated.|At 1, 3, 6, 12, 18, and 24 hours on Days 7, 16, 17, and 19|Percentages are based on the number of participants in the Evaluable Population in each treatment group. Evaluable participants number in Group 1 at time point Day 7/1 Hour, Day 7/3 Hour, Day 7/6 Hour, Day 7/12 Hour was 12.||percentage||95% Confidence Interval|Mean
643770|NCT02229461|Secondary|Inhibition of Arachidonic Acid (AA)-Induced Platelet Aggregation on Days 7, 16, 17, and 19 at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration|Inhibition of AA-induced platelet aggregation at each time point were calculated using the percentage of reduction from baseline as follows: Inhibition (%) = 100 × (Baseline Value – Post-baseline Value) / Baseline Value. For primary analysis, the mean and the lower bound of the corresponding one-sided 95% CI were calculated. The platelet aggregation change-from-baseline scores range broadly in large part due to inclusion of participants with low baseline platelet aggregation scores.|At 1, 3, 6, 12, 18, and 24 hours on Days 7, 16, 17, and 19|Percentages are based on the number of participants in the Evaluable Population in each treatment group. Evaluable participants number in Group 4 at time point Day 7/1 Hour was 12; 11 in group 6, 7 in Group 5, 12 in Group 6 at Day 16/1 Hour.||percentage||95% Confidence Interval|Mean
643771|NCT02229461|Secondary|Inhibition of Serum TXB2 on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours (Except at 24 Hours on Day 16) Post IR ASA 81 mg Administration|Inhibition of serum TXB2 at each time point were calculated using the percentage of reduction from baseline as follows: Inhibition (%) = 100 × (Baseline Value – Post-baseline Value) / Baseline Value. For primary analysis, the mean and the lower bound of the corresponding one-sided 95% CI were calculated.|At 1, 3, 6, 12, 18, and 24 hours on Days 7, 16, 17, and 19 (except 24 hours on Day 16)|Percentages are based on the number of participants in the Evaluable Population in each treatment group.||percentage||95% Confidence Interval|Mean
643772|NCT02229461|Primary|Inhibition of Serum Thromboxane B2 (TXB2) on Day 16 at 24 Hour Post IR ASA 81 mg Administration|Inhibition of serum TXB2 at specified time point was calculated using the percentage of reduction from baseline as follows: Inhibition (%) = 100 × (Baseline Value – Post-baseline Value) / Baseline Value. For primary analysis, the mean and the lower bound of the corresponding one-sided 95% Confidence Interval (CI) were calculated.|At hour 24 on Day 16 post treatment|Percentages are based on the number of participants in the Evaluable Population in each treatment group.||percentage||95% Confidence Interval|Mean
646151|NCT02153489|Other Pre-specified|Change From Baseline in Sleep Efficiency|Sleep efficiency is calculated as the total sleep time as a proportion of total time in bed|Week 3 of treatment|||Percentage of total time in bed||Standard Error|Least Squares Mean
643788|NCT02229318|Secondary|Ease of Preparation of FruitiVits|"Ease of preparation of FruitiVits was rated on a scale of 1-5:
(very easy)
(moderately easy)
(neither easy nor difficult)
(moderately difficult)
(very difficult).
Those who considered it not difficult to prepare and scored 1-3 on the scale: 11/11 patients"|Day 8 of trial|Children aged 4 to 8 years.||participants|||Number
643789|NCT02229318|Primary|Acceptability of FruitiVits|"The study product was rated on a scale of 1-5:
(liked very much)
(liked moderately)
(neither liked nor disliked)
(disliked moderately)
(disliked very much)."|Day 8 of trial|Children aged 4 to 8 years.||participants|||Number
643790|NCT02229214|Secondary|Percentage of Subjects With a Decrease of >/= 15% in Iohexol Clearance From Baseline to 28 Days After End of Treatment||Baseline, 28 days after end of treatment|||percent of participants|||Number
643791|NCT02229214|Secondary|Percentage of Subjects With a Decrease of >/= 15% in Iohexol Clearance From Baseline to End of Treatment||Baseline, end of treatment|||percent of participants|||Number
643792|NCT02229214|Secondary|Change in Cystatin C From Baseline to 28 Days After End of Treatment||Baseline, 28 days after end of treatment|The number analyzed in this outcome measure are those subjects who have both baseline and 28 days after end of treatment cystatin C measurements.||mg/L||Standard Error|Mean
643793|NCT02229214|Primary|Change in iGFR (Glomerular Filtration Rate as Measured by Iohexol Clearance) From Baseline to 28 Days After End of Treatment|"Method that uses iohexol clearance and body surface area to measure kidney function.
Iohexol is an FDA-approved non-radioactive iodine-containing substance widely used in radio-imaging procedures and as a marker for the measurement of in GFR"|Baseline, 28 days after end of treatment|The number analyzed in this outcome measure are those subjects who have both baseline and 28 days after treatment iGFR measurements.||mL/min/1.73 m^2||Standard Error|Mean
643794|NCT02229214|Secondary|Change in Cystatin C From Baseline to End of Treatment||Baseline, end of treatment|The number analyzed in this outcome measure are those subjects who have both baseline and end of treatment cystatin C measurements.||mg/L||Standard Error|Mean
643795|NCT02229214|Secondary|Change in Serum Creatinine From Baseline to 28 Days After End of Treatment||Baseline, 28 days after end of treatment|The number analyzed in this outcome measure are those subjects who have both baseline and 28 days after end of treatment serum creatinine measurements.||mg/dL||Standard Error|Mean
643796|NCT02229214|Secondary|Change in Serum Creatinine From Baseline to End of Treatment||Baseline, end of treatment|The number analyzed in this outcome measure are those subjects who have both baseline and end of treatment serum creatininine measurements||mg/dL||Standard Error|Mean
643811|NCT02228395|Secondary|Apparent Volume of Distribution (Vz/F)||0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose|The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||liters||Geometric Coefficient of Variation|Geometric Mean
643797|NCT02229214|Primary|Change in iGFR (Glomerular Filtration Rate as Measured by Iohexol Clearance) From Baseline to End of Treatment|"Method that uses iohexol clearance and body surface area to measure kidney function.
Iohexol is an FDA-approved non-radioactive iodine-containing substance widely used in radio-imaging procedures and as a marker for the measurement of in GFR."|Baseline, end of treatment|The number analyzed in this outcome measure are those subjects who have both baseline and end of treatment iGFR measurements.||mL/min/1.73 m^2||Standard Error|Mean
643798|NCT02228980|Other Pre-specified|Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine|"Solicited injection site: Tenderness/Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic: Fever, (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability (≤ 23 months); Fever, Headache, Malaise, Myalgia, and Shivering (≥2 years).
Grade 3: Tenderness - Cries if injected limb is moved; Pain - Incapacitating; Erythema, Swelling, Induration, Ecchymosis, ≥ 50 mm or 100 mm age ≥ 12 years: Fever >39.5˚C; Crying abnormal - >3 hours; Drowsiness - Difficulty waking; Appetite lost - Refuses ≥3 meals; Irritability - Inconsolable; Vomiting - ≥6 incidents per 24 hours: Fever ≥39.0˚C; Headache, Malaise, Myalgia, and Shivering - Prevents activity (≥ 2 years)"|Day 0 up to Day 7 post any vaccination|Solicited injection site and systemic reactions were assessed in the Safety Population.||Participants|||Number
643799|NCT02228980|Other Pre-specified|Percentage of Participants With Seroconversion or Significant Increase in Influenza Antibody Titers Following Vaccination With a Trivalent Inactivated Influenza Vaccine|Anti hemagglutinin (HA) antibody titers were measured using the Hemagglutination Inhibition (HAI) technique. Seroconversion was defined as titers < 10 (1/dil) on Day 0 and post vaccination titer ≥ 40 (1/dil) on Day 28 or Day 56 or significant increase was titers ≥ 10 (1/dil) on Day 0 and ≥ 4-fold increase of post-vaccination titer on Day 28 or Day 56.|Day 0 (pre-vaccination) up to Day 28 or Day 56 (Age 6 to 35 Months Group) post-vaccination|Seroconversion or significant increase against the trivalent inactivated influenza vaccine were assessed in the Immunogenicity Analysis Set.||Percentage of participants|||Number
643800|NCT02228980|Other Pre-specified|Percentage of Participants With Seroprotection Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine|Anti-hemagglutinin (HA) antibody titers were measured using the Hemagglutination Inhibition (HAI) technique. Seroprotection was defined as titers ≥ 40 (1/dil) on Day 0 and Day 28 or Day 56.|Day 0 (pre-vaccination) up to Day 28 or Day 56 (Age 6 to 35 Months Group) post-vaccination|Seroprotection against the trivalent inactivated influenza vaccine were assessed in the Immunogenicity Analysis Set.||Percentage of participants|||Number
643801|NCT02228980|Primary|Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine|Anti-hemagglutinin (HA) antibody titers were measured using the Hemagglutination Inhibition (HAI) technique.|Day 0 (pre-vaccination) up to Day 28 or Day 56 (Age 6 to 35 Months Group) post-vaccination|Geometric mean titers against the trivalent inactivated influenza vaccine antigens were assessed in the Immunogenicity Analysis Set.||Titers (1/dilution)||95% Confidence Interval|Geometric Mean
643802|NCT02228720|Secondary|Sino-Nasal Outcome Test (SNOT) 22|Validated, disease-specific, symptom-scoring instrument consisting of 22 questions, each scored by the patient on a scale of 0 (no problem) to 5 (problem as bad as it can be), resulting in a maximum total score of 110|Baseline, Day 30, Day 90|Adult patients (≥ 18 years of age) diagnosed with chronic sinusitis with or without nasal/sinus polyposis who are candidates for endoscopic sinus surgery and in whom placement of the Propel Nova Sinus Implant is both feasible and medically appropriate||units on a scale||Standard Deviation|Mean
643803|NCT02228720|Secondary|Degree of Inflammation|Inflammation visual analog scale (VAS) from 0 (no visible inflammation) to 100 (severe inflammation, involving significant and extensive erythema and edema and/or hypertrophy and/or polypoid changes)|Baseline, Day 30, Day 90|Frontal and maxillary sinus ostia||units on a scale|Sinuses|Standard Deviation|Mean
643804|NCT02228720|Secondary|Adhesion/Scarring Grade 2 & 3|Adhesion/scarring grading scale from 0 (No visible granulation/scarring), 1 (Minimal amount of scarring/contraction observed but non-obstructing the frontal or maxillary sinus ostium), 2 (moderate amount of obstructive scar tissue/contraction present in the frontal or maxillary sinus ostium), 3 (Significant scar tissue/ contraction causing obstruction of the frontal or maxillary sinus ostium)|Baseline, Day 30, Day 90|Frontal and maxillary sinus ostia||percentage of evaluable sinuses|Sinuses||Number
643805|NCT02228720|Secondary|Ostial Patency|Ostial patency grading scale from 0 (patent) to 1 (Occluded/Restenosed)|Baseline, Day 30, Day 90|Frontal and maxillary sinus ostia||percentage of evaluable sinuses|Sinuses||Number
643806|NCT02228720|Primary|Device Placement Success Rate|Defined as successful access to and placement of the Propel Nova Sinus Implant in the frontal or maxillary sinus ostium within two attempts. Calculated as a proportion where the numerator is the number of successful device placements and the denominator is the number of attempted sinuses.|Baseline Procedure|Attempted frontal and maxillary sinus ostia||Percentage of attempted sinuses|Sinuses||Number
643807|NCT02228395|Secondary|Dose Normalized AUCinf (AUCinf[dn])||0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose|The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng*h/mL/mg||Geometric Coefficient of Variation|Geometric Mean
643808|NCT02228395|Secondary|Dose Normalized AUClast (AUClast[dn])||0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose|The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng*h/mL/mg||Geometric Coefficient of Variation|Geometric Mean
643809|NCT02228395|Secondary|Dose Normalized Cmax (Cmax[dn])||0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose|The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||mg/mL/mg||Geometric Coefficient of Variation|Geometric Mean
643810|NCT02228395|Secondary|Terminal Elimination Half-Life (t1/2)|Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half.|0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose|The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||hours||Standard Deviation|Mean
648276|NCT02107014|Primary|Change in IL-12p40 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].|||pg/mL||95% Confidence Interval|Median
643812|NCT02228395|Secondary|Apparent Clearance (CL/F)||0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose|The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||milliliters per minute (mL/min)||Geometric Coefficient of Variation|Geometric Mean
643813|NCT02228395|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)||0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose|The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
643814|NCT02228395|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)||0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose|The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||nanograms*hours per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
643815|NCT02228395|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose|The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||hours||Full Range|Median
643816|NCT02228395|Secondary|Maximum Observed Plasma Concentration (Cmax)||0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose|The pharmacokinetic (PK) parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest in at least 1 treatment period.||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
643817|NCT02228395|Primary|Number of Participants With Abnormal Neurological Examination Findings|The extended neurological examination, performed by a board certified neurologist, included observation for cerebellar (intention) tremor and for non-cerebellar tremors (eg, resting or positional), finger nose, heel shin, Romberg, tandem walking, positional and gaze evoked nystagmus, reflexes, muscle strength, cranial nerves, sensory function of upper and lower extremities. The brief neurological examination included an assessment of motor and sensory function, cranial nerves, reflexes, non-cerebellar tremor (eg, resting or positional) and cerebellar function. The assessment of cerebellar function were complemented by the Scale for Assessment and Rating of Ataxia (SARA)|Baseline up to Day 10|||participants|||Number
643818|NCT02228395|Primary|Number of Participants With Abnormal Physical Examination Findings|A full physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. The brief physical examination focused on general appearance, the respiratory and cardiovascular systems, as well as towards participant reported symptoms.|Baseline up to Day 10|||participants|||Number
643819|NCT02228395|Primary|Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings|ECG parameters included pulse rate (PR) interval, QRS interval, corrected QT interval using Bazett's formula (QTcB)and corrected QT interval using Fridericia's formula (QTcF). Criteria for ECG changes meeting potential clinical concern included: PR interval greater than or equal to (>=)300 milliseconds (msec) or >=25% increase when baseline is greater than (>)200 msec and >=50% increase when baseline is less than or equal to (=<)200 msec; QRS interval >=140 msec or >=50% increase from baseline (IFB); and QTcF >=450 msec or >=30 msec increase. The number of participants with potentially clinically significant ECG findings at any visit were reported.|Baseline up to Day 10|The safety analysis population included all participants who received the study medication; n=number of participants evaluated against criteria.||participants|||Number
643820|NCT02228395|Primary|Number of Participants With Potentially Clinically Significant Vital Signs Findings|Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: supine/sitting pulse rate <40 or >120 beats per minute (bpm), standing pulse rate <40 or >140 bpm; systolic blood pressure (SBP) >=30 millimeters of mercury (mm Hg) change from baseline in same posture or SBP <90 mm Hg, diastolic blood pressure (DBP) >=20 mm Hg change from baseline in same posture or DBP <50 mm Hg. IFB = increase from baseline; DFB = decrease from baseline.|Baseline up to Day 10|The safety analysis population included all participants who received the study medication.||participants|||Number
643821|NCT02228395|Primary|Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern|The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell [RBC] count, mean corpuscular volume [MCV], mean corpuscular hemoglobin [MCH], mean corpuscular hemoglobin concentration [MCHC], platelet count, white blood cell [WBC] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen [BUN], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, alkaline phosphatase, uric acid, albumin, and total protein; urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin and microscopy [if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase]); others (follicle stimulating hormone [FSH], and urine drug screening).|Baseline up to Day 10|The safety analysis population included all participants who received the study medication.||participants|||Number
643822|NCT02228395|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.|Baseline up to 28 days after last study drug administration.|The safety analysis population included all participants who received the study medication.||participants|||Number
643871|NCT02226198|Secondary|Physical Exam Abnormalitites|Safety and tolerability will be described in terms of abnormal physical examinations. Only parameters for which abnormalities were found are reported.|Screening, Week 0, week 6, week 12 and week 18, week 24|||participants|||Number
643872|NCT02226198|Secondary|ECG Abnormalities|Safety and tolerability will be described in terms of abnormal electro cardio gram (ECG)|Week 0|||participants|||Number
643823|NCT02228395|Primary|Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) Post-Baseline|The C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment [C-CASA]) is an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior. C-SSRS assessed whether participant experienced the following: completed suicide (1), suicide attempt (2) (response of “Yes” on “actual attempt”), preparatory acts toward imminent suicidal behavior (3)(“Yes” on “preparatory acts or behavior”), suicidal ideation (4) (“Yes” on “wish to be dead”, “non-specific active suicidal thoughts”, “active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7)(“Yes” on “Has participant engaged in non-suicidal self-injurious behavior”).|Baseline up to Day 10|The safety analysis population included all participants who received the study medication.||participants|||Number
643824|NCT02227810|Secondary|Hospitalization Outcomes|The total days that participants stay in the respiratory care center (RCC).|the day participants were discharged from RCC|t test||days||Standard Deviation|Mean
643825|NCT02227810|Primary|Pulmonary Function|The pulmonary function as assessed by the measurement of tidal volume.|end of intervention|t -test||ml||Standard Deviation|Mean
643826|NCT02227810|Primary|Muscle Strength|The muscle strength of quadriceps were assessed by Medical Research Council (MRC) scoring system. The MRC score ranges from a 0 points (zero strength) to 5 points (good). The higher points indicated the better muscle strength.|end of intervention|||units on a scale||Standard Deviation|Mean
643827|NCT02227810|Primary|Level of Activity of Daily Life|The level of activity of daily life was measured by Functional Independence Measure (FIM) score. Possible scores range from 18 (total assist) to 126 (complete independence).|end of intervention|||units on a scale||Standard Deviation|Mean
643828|NCT02227485|Primary|Modified Gingival Index|"0= Absence of inflammation
Mild inflammation or with slight changes in color and texture but not in all portions of gingival marginal or papillary
Mild inflammation, such as the preceding criteria, in all portions of gingival marginal or papillary
moderate, bright surface inflammation, erythema, edema and/or hypertrophy of gingival marginal or papillary
severe inflammation: erythema, edema and/or marginal gingival hypertrophy of the unit or spontaneous bleeding, papillary, congestion or ulceration"|At the beginning, after 2 weeks and after 4 weeks.|The number of analysed cases for the base line section are 40 and for other sections (after 2 weeks and 4 weeks) are 34 for Chlorhexidine group and 36 for Punica granatum group.||units on a scale||Standard Deviation|Mean
643829|NCT02227485|Primary|Pocket Depth|It is the depth of the dental sulcus which detected by measuring the depth of sulcular insertion of the probe at six sites; mesiofacial, midfacial, distofacial, mesiolingual, midlingual and distolingual of all teeth divided by the teeth number. the measurement unit is millimeter (mm).|At the beginning, after 2 weeks and after 4 weeks|The number of analysed cases for the base line section are 40 and for other sections (after 2 weeks and 4 weeks) are 34 for Chlorhexidine group and 36 for Punica granatum group.||mm||Standard Deviation|Mean
643830|NCT02227485|Secondary|Satisfaction of Patients|"We use a Visual Analogue Scale (VAS) to evaluate the patients' satisfaction and their tolerance.
This VAS ranged from 1 (not satisfied at all) to 5 (fully satisfied) was used:
Not satisfied at all
Not satisfied adequately
Not good-Not bad (So So)
Mostly Satisfied
Fully satisfied"|Up to 2 week|||participants|||Number
643831|NCT02227485|Secondary|Number of Participants With Adverse Events||Up to 2 weeks|||participants|||Number
643832|NCT02227485|Primary|Bleeding Index|"presence of bleeding of the gum when probing it: 0= No bleeding
1= Bleeding occurs within 10 seconds after gentle probing of the orifice of the gingival crevice"|At the beginning, after 2 weeks and after 4 weeks.|The number of analysed cases for the base line section are 40 and for other sections (after 2 weeks and 4 weeks) are 34 for Chlorhexidine group and 36 for Punica granatum group.||units on a scale||Standard Deviation|Mean
643833|NCT02227485|Primary|Plaque Index|"0 No plaque
A film of plaque adhering to the free gingival margin and adjacent area of the tooth, which cannot be seen with the naked eye. But only by using disclosing solution or by using probe.
Moderate accumulation of deposits within the gingival pocket, on the gingival margin and/ or adjacent tooth surface, which can be seen with the naked eye.
Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin."|At the beginning, after 2 weeks and after 4 weeks|The number of analysed cases for the base line section are 40 and for other sections (after 2 weeks and 4 weeks) are 34 for Chlorhexidine group and 36 for Punica granatum group.||units on a scale||Standard Deviation|Mean
643834|NCT02227368|Secondary|Change From Baseline in Log Transformed Claudication Onset Time (COT) at Week 26 or Early Termination (ET)||26 Weeks|ITT population is the analysis population. Twelve subjects without evaluable baseline were excluded from the analysis.||log(Second)||95% Confidence Interval|Mean
643835|NCT02227368|Primary|Change From Baseline in Log Transformed Peak Walking Time (PWT) at Week 26 or Early Termination (ET)||26 Weeks|ITT population is the analysis population. Six subjects without evaluable baseline were excluded from the analysis.||log(Second)||95% Confidence Interval|Mean
643836|NCT02227121|Primary|Defibrillation Outcome|Subjects will demonstrate a successful defibrillation outcome if they have a successful defibrillation shock with the research system.|Day of procedure|Only subjects with ventricular fibrillation successfully induced were eligible for analysis||Participants|||Count of Participants
643837|NCT02227108|Secondary|Systemic Clearance (CL) After the First Dose of Cycle 1|CL is a quantitative measure of the rate at which a drug substance is removed from the body. The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by the plasma Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]).|Pre-infusion, end of infusion (EOI); 1, 3, and 6 hours post-infusion at Day 1 of Cycle 1|"Safety population who provided at least one measurable Pharmacokinetic concentration. Here, number of participants analysed, N included evaluable participants for this outcome measure."||milliliter per hour per kilogram||Full Range|Mean
643850|NCT02227108|Secondary|Duration of Overall Response (DOR)|DOR was to be defined as the duration from the first documentation of overall response to the first documented disease progression. Kaplan-Meier method was used for evaluation.|Prior to Cycle 1, and prior to every cycle, at the end of treatment, at post-treatment follow-up visits, and at the end of the study, up to 1 year|Efficacy evaluable population included all participants who received any amount of moxetumomab pasudotox and completed a baseline disease assessment and had at least one post-baseline disease assessment.||months||Full Range|Median
643838|NCT02227108|Secondary|Terminal Phase Elimination Half Life (t1/2) After the First Dose of Cycle 1|Terminal phase elimination half-life is the time measured for the serum/plasma concentration to decrease by one half, calculated as natural logarithmic (log)-transformed (ln) value of 2 divided by elimination rate constant (lambda); that is [ln(2)/lambda]. Elimination rate constant (lambda) was estimated via linear regression of the time versus log concentration.|Pre-infusion, end of infusion (EOI); 1, 3, and 6 hours post-infusion at Day 1 of Cycle 1|"Safety population who provided at least one measurable Pharmacokinetic concentration. Here, number of participants analysed, N included evaluable participants for this outcome measure."||hour||Full Range|Median
643839|NCT02227108|Secondary|Time to Reach Maximum Drug Concentration in Plasma (Tmax) After the First Dose of Cycle 1|Tmax refers to the time after dosing when a drug attains its highest measurable concentration (Cmax). It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content.|Pre-infusion, end of infusion (EOI); 1, 3, and 6 hours post-infusion at Day 1 of Cycle 1|Safety population who provided at least one measurable Pharmacokinetic concentration.||hour||Standard Deviation|Mean
643840|NCT02227108|Secondary|Maximum Observed Drug Concentration in Plasma (Cmax) After the First Dose of Cycle 1|Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.|Pre-infusion, end of infusion (EOI); 1, 3, and 6 hours post-infusion at Day 1 of Cycle 1|Safety population who provided at least one measurable Pharmacokinetic concentration.||nanogram per milliliter||Standard Deviation|Mean
643841|NCT02227108|Secondary|Area Under the Concentration Versus Time Curve From Time Zero to Last Quantifiable Concentration [AUC0-last] After the First Dose of Cycle 1|AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. AUC0-t is defined as AUC from time zero to the last data point above the lower limit of quantification.|Pre-infusion, end of infusion (EOI); 1, 3, and 6 hours post-infusion at Day 1 of Cycle 1|"Safety population who provided at least one measurable Pharmacokinetic concentration. Here, number of participants analysed, N included evaluable participants for this outcome measure."||hour*nanogram per milliliter (hr*ng/mL)||Standard Deviation|Mean
643842|NCT02227108|Secondary|Area Under the Plasma Concentration Time Curve From Time 0 to Infinity (AUC0-inf) After the First Dose of Cycle 1|AUC (0-infinity) = Area under the serum concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-infinity). It is obtained from AUC (0-t) plus AUC (tinfinity). It was calculated by extrapolating the concentrationtime curve from time zero to infinity using the linear/log trapezoidal rule.|Pre-infusion, end of infusion (EOI); 1, 3, and 6 hours post-infusion of Day 1 of Cycle 1|"Safety population who provided at least one measurable Pharmacokinetic concentration. Here, number of participants analysed, N included evaluable participants for this outcome measure."||hour*nanogram per milliliter (hr*ng/mL)||Standard Deviation|Mean
643843|NCT02227108|Secondary|Number of Participants With Positive Anti-drug Antibody (ADA) and Neutralizing Antibodies (NAb)|Immunogenicity assessment included determination of antidrug (moxetumomab pasudotox) antibodies and neutralizing antidrug antibodies in serum samples. Titers and specificity were determined for NAb-positive participants. Specificity were observed in participants who had ADAs directed to the PE38 domain of moxetumomab pasudotox and increase in titers were observed in participants who tested ADA-positive at baseline. Moxetumomab pasudotox ADA-titer is a validated immunoassay, which determines titers or levels of ADAs present in ADA-positive samples.|Prior to the Start of Each Cycle for Cycles 1, 2, 3, and Subsequent Odd-Numbered Cycles, End of Treatment, and 30 Day Follow-up Visit, up to 1 year|"Safety population includes all participants who received any amount of moxetumomab pasudotox. Here, number of participants analysed, N included participants with at least one post-baseline sample."||participants|||Number
643844|NCT02227108|Secondary|Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)|Participants who experienced vital signs abnormalities recorded as TEAEs were reported.|Baseline up to 30 days after the last dose of study drug, up to 1 year|Safety population includes all participants who received any amount of moxetumomab pasudotox.||participants|||Number
643845|NCT02227108|Secondary|Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities|Participants were evaluated for ECG abnormalities.|Baseline up to 30 days after the last dose of study drug, up to 1 year|Safety population includes all participants who received any amount of moxetumomab pasudotox.||participants|||Number
643846|NCT02227108|Secondary|Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAE)|Laboratory tests were grouped according to hematology, serum chemistry, and urinalysis. Laboratory abnormalities with toxicity grades according to NCI CTCAE Version 4.03 were derived according to laboratory values and reported as treatment-emergent adverse events.|Baseline up to 30 days after the last dose of study drug, up to 1 year|Safety population includes all participants who received any amount of moxetumomab pasudotox.||participants|||Number
643847|NCT02227108|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|Treatment-emergent adverse events (TEAEs), were defined as events present at baseline that worsened in intensity after administration of investigational product or events absent at baseline that emerged after administration of study drug.|Baseline up to 30 days after the last dose of study drug, up to 1 year|Safety population includes all participants who received any amount of moxetumomab pasudotox.||participants|||Number
643848|NCT02227108|Secondary|Overall Survival (OS)|OS was determined as the time from the start of treatment with moxetumomab pasudotox until death due to any cause. For participants who were alive at the end of the study or lost to follow-up, OS was censored on the last date when the participant was known be alive. Kaplan-Meier method was used for evaluation.|Baseline to end of study or last contact date, up to 1 year|Efficacy evaluable population included all participants who received any amount of moxetumomab pasudotox and completed a baseline disease assessment and had at least one post-baseline disease assessment.||months||Full Range|Median
643849|NCT02227108|Secondary|Progression-Free Survival (PFS)|PFS was measured from the start of treatment with moxetumomab pasudotox until the first documentation of disease progression or death due to any cause, whichever occurred first. Kaplan-Meier method was used for evaluation.|Prior to Cycle 1, and prior to every cycle, at the end of treatment, at post-treatment follow-up visits, and at the end of the study, up to 1 year|Efficacy evaluable population included all participants who received any amount of moxetumomab pasudotox and completed a baseline disease assessment and had at least one post-baseline disease assessment.||months||Full Range|Median
643851|NCT02227108|Secondary|Duration of Complete Response (DOCR)|DOCR was defined as the duration from the first documentation of CRc to the first documented disease progression.The CRc is defined as achieving complete response (CR), or CR with incomplete count recovery [CRi]) in participants with relapsed or refractory B-cell ALL or B-cell lymphoblastic lymphoma. Kaplan-Meier method was used for evaluation.|Prior to Cycle 1, and prior to every cycle, at the end of treatment, at post-treatment follow-up visits, and at the end of the study, up to 1 year|"Efficacy evaluable population included all participants who received any amount of moxetumomab pasudotox and completed a baseline disease assessment and had at least one post-baseline disease assessment. Here, number of participants analysed, N included evaluable participants for this outcome measure."||months|||Number
643852|NCT02227108|Secondary|Percentage of Participants Who Were Neutropenic at Study Entry and Who Experienced Hematologic Activity (HA)|The percentage of participants who were neutropenic at study entry and experienced HA after treatment with moxetumomab pasudotox was evaluated. The Clopper Pearson (Exact) 95% CI was calculated.|Prior to Cycle 1, and prior to every cycle, at the end of treatment, at post-treatment follow-up visits, and at the end of the study, up to 1 year|Efficacy evaluable population included all participants who received any amount of moxetumomab pasudotox and completed a baseline disease assessment and had at least one post-baseline disease assessment.||percentage of participants|||Number
643853|NCT02227108|Secondary|Time to Transplant to Receive an Stem Cell Transplant (SCT) After Treatment With Moxetumomab Pasudotox|The time to SCT was defined as the duration from the start of treatment with moxetumomab pasudotox until the date when the subject became eligible for SCT. The time to SCT was to be summarized using the Kaplan-Meier method, and was only to be evaluated for the subgroup of subjects who became eligible for SCT after treatment with moxetumomab pasudotox.|Prior to Cycle 1, and prior to every cycle, at the end of treatment, at post-treatment follow-up visits, and at the end of the study, up to 1 year|Efficacy population included participants who received moxetumomab pasudotox, completed a baseline disease assessment and had at least one post-baseline assessment. Since study was terminated prematurely, no participant received SCT after treatment with moxetumomab pasudotox, hence data were not collected for this Outcome measure.|||||
643854|NCT02227108|Secondary|Percentage of Participants Who Became Eligible to Receive an Stem Cell Transplant (SCT) After Treatment With Moxetumomab Pasudotox|The percentage of participants who became eligible for SCT after treatment with moxetumomab pasudotox were provided. The Clopper Pearson (Exact) 95% CI was calculated.|Prior to Cycle 1, and prior to every cycle, at the end of treatment, at post-treatment follow-up visits, and at the end of the study, up to 1 year|Efficacy evaluable population included all participants who received any amount of moxetumomab pasudotox and completed a baseline disease assessment and had at least one post-baseline disease assessment.||percentage of participants|||Number
643855|NCT02227108|Secondary|Bone Marrow Blast Percentage Change|Change in bone marrow blast percentage from baseline was evaluated. If the percentage (%) blasts (at least 200 cells counted) is less than (<) 5%, it is considered as M1, 5 to 25% considered as M2, greater than (>) 25% considered as M3. Stages with the higher blasts relate to worse outcomes.|Prior to Cycle 1, and prior to every cycle, at the end of treatment, at post-treatment follow-up visits, and at the end of the study, up to 1 year|"The intent to treat (ITT) population included all participants who entered the study. Here, number of participants analysed, N included evaluable participants for this outcome measure."||percentage of participants|||Number
643856|NCT02227108|Secondary|Best Overall Response (BOR)|The best overall response was calculated, based upon the disease assessments recorded during the study visits, and summarized with the number and percentage of participants for the following categories: CRc, PR, HA, SD, PD, and not evaluable. Overall best response is the best response observed for a participant during the study based on International Working Group (IWG) Response Criteria for malignant lymphoma. Complete response (CR) as per IWG is complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. PR is a minimum of 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses and no increase in the size of other nodes and in size of liver or spleen. Stable disease (SD) is when a participant fails to attain the criteria needed for a CR or PR, but does not fulfill those for PD.|Prior to Cycle 1, and prior to every cycle, at the end of treatment, at post-treatment follow-up visits, and at the end of the study, up to 1 year|Efficacy evaluable population included all participants who received any amount of moxetumomab pasudotox and completed a baseline disease assessment and had at least one post-baseline disease assessment.||percentage of participants|||Number
643857|NCT02227108|Secondary|Time to Overall Response|Time to overall response was evaluated using the Kaplan-Meier method.|Prior to Cycle 1, and prior to every cycle, at the end of treatment, at post-treatment follow-up visits, and at the end of the study, up to 1 year|Efficacy evaluable population included all participants who received any amount of moxetumomab pasudotox and completed a baseline disease assessment and had at least one post-baseline disease assessment.||months||95% Confidence Interval|Median
643858|NCT02227108|Secondary|Overall Response Rate (ORR)|The ORR, defined as the percentage of participants with CRc or partial response (PR), was estimated; the Clopper Pearson (Exact) 95% CI was calculated. The CRc is defined as complete response (CR), or complete response with incomplete count recovery (CRi). Complete response (CR) as per International Working Group (IWG) is complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. Morphologic CR with incomplete blood count recovery (CRi) is defined as the above CR criteria without specified blood counts.|Prior to Cycle 1, and prior to every cycle, at the end of treatment, at post-treatment follow-up visits, and at the end of the study, up to 1 year|Efficacy evaluable population included all participants who received any amount of moxetumomab pasudotox and completed a baseline disease assessment and had at least one post-baseline disease assessment.||percentage of participants||95% Confidence Interval|Number
643868|NCT02226549|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 8 weeks|Safety Analysis Set: participants who received at least 1 dose of study drug.||percentage of participants|||Number
643869|NCT02226549|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants who were randomized and received at least 1 dose of study drug.||percentage of participants|||Number
643859|NCT02227108|Secondary|Percentage of Participants With Minimal Residual Disease (MRD)-Negative CRc Rate|The MRD-negative CRc rate was defined as the percentage of participants who achieved CRc and became MRD-negative as determined by flow cytometry performed by a central analysis laboratory. The CRc is defined as complete response (CR), or complete response with incomplete count recovery (CRi). Complete response (CR) as per International Working Group (IWG) is complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. Morphologic CR with incomplete blood count recovery (CRi) is defined as the above CR criteria without specified blood counts.|Prior to Cycle 1, and prior to every cycle, at the end of treatment, at post-treatment follow-up visits, and at the end of the study, up to 1 year|Efficacy evaluable population included all participants who received any amount of moxetumomab pasudotox and completed a baseline disease assessment and had at least one post-baseline disease assessment.||percentage of participants|||Number
643860|NCT02227108|Primary|Percentage of Participants With Composite Complete Response (CRc)|The CRc is defined as achieving complete response (CR), or CR with incomplete count recovery [CRi]) in participants with relapsed or refractory B-cell ALL or B-cell lymphoblastic lymphoma. Complete response (CR) as per International Working Group (IWG) is complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. Morphologic CR with incomplete blood count recovery (CRi) is defined as the above CR criteria without specified blood counts. The efficacy assessments were evaluated as per investigator assessment.|Prior to Cycle 1, and prior to every cycle, at the end of treatment, at post-treatment follow-up visits, and at the end of the study, up to 1 year|Efficacy evaluable population included all participants who received any amount of moxetumomab pasudotox and completed a baseline disease assessment and had at least one post-baseline disease assessment.||percentage of participants||95% Confidence Interval|Number
643861|NCT02226562|Secondary|Mean Change From Baseline in VRS at Week 4|Participants rated the intensity of their response to an evaporative air stimulus using a 10 point VRS scale with 1 indicating 'no pain' and 10 indicating 'Intense pain'. A reduction in the score is indicative of an improvement in sensitivity.|Baseline to 4 week|The primary population for efficacy assessment was intent-to-treat (ITT) population.The ITT population comprised of participants, who were randomized, received at least one dose of study treatment and provided at least one post-baseline assessment of efficacy.||Score on scale||Standard Deviation|Mean
643862|NCT02226562|Secondary|Mean Change From Baseline in Visual Rating Scale (VRS) at Week 8|Participants rated the intensity of their response to an evaporative air stimulus using a 10 point VRS scale with 1 indicating 'no pain' and 10 indicating 'Intense pain'. A reduction in the score is indicative of an improvement in sensitivity.|Baseline to 8 week|The primary population for efficacy assessment was intent-to-treat (ITT) population.The ITT population comprised of participants, who were randomized, received at least one dose of study treatment and provided at least one post-baseline assessment of efficacy.||Score on scale||Standard Deviation|Mean
643863|NCT02226562|Secondary|Mean Change From Baseline in Tactile Threshold at Week 4|The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the subject whether the sensation caused discomfort. The pressure setting at which the subject gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g.|Baseline to 4 week|The primary population for efficacy assessment was intent-to-treat (ITT) population.The ITT population comprised of participants, who were randomized, received at least one dose of study treatment and provided at least one post-baseline assessment of efficacy.||Gram (g)||Standard Deviation|Mean
643864|NCT02226562|Secondary|Mean Change From Baseline in Tactile Threshold at Week 8|The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the subject whether the sensation caused discomfort. The pressure setting at which the subject gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g.|Baseline to 8 week|The primary population for efficacy assessment was intent-to-treat (ITT) population.The ITT population comprised of participants, who were randomized, received at least one dose of study treatment and provided at least one post-baseline assessment of efficacy.||Gram(g)||Standard Deviation|Mean
643865|NCT02226562|Secondary|Mean Change From Baseline in Schiff Sensitivity Score at Week 4|The examiner indicated the participant's response to an evaporaitve air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score is indicative of an imrpovement in sensitivity.|Baseline to 4 week|The primary population for efficacy assessment was intent-to-treat (ITT) population.The ITT population comprised of participants, who were randomized, received at least one dose of study treatment and provided at least one post-baseline assessment of efficacy.||Scores on scale||Standard Deviation|Mean
643866|NCT02226562|Primary|Mean Change From Baseline in Schiff Sensitivity Score at Week 8|The examiner indicated the participant's response to an evaporaitve air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score is indicative of an imrpovement in sensitivity.|Baseline to 8 week|The primary population for efficacy assessment was intent-to-treat (ITT) population.The ITT population comprised of participants, who were randomized, received at least one dose of study treatment and provided at least one post-baseline assessment of efficacy.||Score on scale||Standard Error|Least Squares Mean
643867|NCT02226549|Secondary|Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)|SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.|Posttreatment Week 4|Full Analysis Set||percentage of participants|||Number
643880|NCT02226198|Secondary|Tanner Stage|"Stages for fem (Pubic hair, Breasts):
(Preadol,Preadol)
(Sparse, lightly pigmented, medial border of labia,Breast and papilla elevated as small mound; areolar diam incr)
(Darker, beginning to curl, incr amount, Breast and areola enlarged, no contour separation)
(Course, curly, abundant but less amount in adult,Areola and papilla form secondary mound)
(Adult fem triangle, spread to medial surface of thighs,Mature, nipple projects, areola part of general breast contour) For males (Pubic hair, Penis, Testes)
1=(None,Preadol,Preadol) 2=(Scanty, long, light pigm,Slight enl,Enl scrotum, pink texture alt) 3=(Darker, starts to curl, small amount,Longer,Larger) 4=(Resembles adult type, but less in quant; course, curly,Larger; glans and breadth increased in size,Larger, scrotum dark) 5=(Adult distr, spread to medial thighs,Adult size,Adult size). Progr at a normal rate is preferred. Regr is not preferred."|Week 0 (start of cross-over)|||stage||Standard Deviation|Mean
643881|NCT02226198|Secondary|Weight|Safety and tolerability will be described in terms of growth, including height (linear growth [cm and standard deviation (SD) score]), and weight.|Week 0 (start of cross-over), weeks 6, week 12 and week 18|||kg||Standard Deviation|Mean
643882|NCT02226198|Secondary|Height Z-score|Safety and tolerability will be described in terms of growth, including height (linear growth [cm and standard deviation (SD) score]), and weight.|Week 0 (start of cross-over), weeks 6, week 12 and week 18|||ratio||Standard Deviation|Mean
643883|NCT02226198|Secondary|Height|Safety and tolerability will be described in terms of growth, including height (linear growth [cm and standard deviation (SD) score]), and weight.|Week 0 (start of cross-over), weeks 6, week 12 and week 18|||cm||Standard Deviation|Mean
643884|NCT02226198|Secondary|Abnormal Serum Levels|Safety and tolerability will be described in terms of abnormal serum laboratory values. The reported parameters are not the only ones measured, but rather those for which abnormailities were found|From screening (5-6weeks before dose) up to the last visit Day 168 (approximately 30 weeks after screening)|||participants|||Number
643885|NCT02226198|Secondary|AE's Leading to Discontinuation|Safety and tolerability will be described in terms of rate of discontinuations due to adverse events|From screening (5-6weeks before dose) up to the last visit Day 168 (approximately 30 weeks after screening)|||adverse events|||Number
643886|NCT02226198|Secondary|Adverse Events|Safety and tolerability will be described in terms of frequency and severity of adverse events|From screening (5-6weeks before dose) up to the last visit Day 168 (approximately 30 weeks after screening)|||adverse events|||Number
643887|NCT02226198|Secondary|Trough Concentrations|Pharmacokinetic profile in terms of trough concentrations. Cross-over phase results based on measurements taken after 6 weeks active treatment (rosuvastatin) in the cross-over phase. Maintenance phase results based on measurements taken after 6 weeks active treatment (rosuvastatin) in the maintenance phase.|Samples taken 24 hours post-dose at Day 42 (week 6), Day 84 (week 12), Day 126 (week 18)|||ng/mL||Standard Deviation|Mean
643888|NCT02226198|Secondary|LDL-C From End of Placebo (mmol/L)|Change in low density lipoprotein cholesterol (LDL C) from end of placebo period to 6, 12, and 18 weeks of therapy with rosuvastatin 20 mg|Samples taken at Day 42 (week 6), Day 84 (week 12), Day 126 (week 18) and Day 168 (week 24)|||mmol/L||Standard Deviation|Mean
643889|NCT02226198|Secondary|LDL-C From End of Placebo (mg/dL)|Change in low density lipoprotein cholesterol (LDL C) from end of placebo period to 6, 12, and 18 weeks of therapy with rosuvastatin 20 mg|Samples taken at Day 42 (week 6), Day 84 (week 12), Day 126 (week 18) and Day 168 (week 24)|||mg/dL||Standard Deviation|Mean
643890|NCT02226198|Secondary|LDL-C, Not on Apheresis (mmol/L)|Efficacy in terms of low density lipoprotein cholesterol (LDL C) following 6 weeks rosuvastatin 20 mg or placebo treatment in patients not treated with Apheresis|Samples taken at Day 42 (week 6) and Day 84 (week 12)|Patients not treated with apheresis||mmol/L||Standard Deviation|Mean
643891|NCT02226198|Secondary|LDL-C, Not on Apheresis (mg/dL)|Efficacy in terms of low density lipoprotein cholesterol (LDL C) following 6 weeks rosuvastatin 20 mg or placebo treatment in patients not treated with Apheresis|Samples taken at Day 42 (week 6) and Day 84 (week 12)|Patients not treated with apheresis||mg/dL||Standard Deviation|Mean
643892|NCT02226198|Secondary|HDL-C (mmol/L)|Efficacy in terms of high density lipoprotein cholesterol (HDL C)|Samples taken at Day 42 (week 6) and Day 84 (week 12)|||mmol/L||Standard Deviation|Mean
643893|NCT02226198|Secondary|HDL-C (mg/dL)|Efficacy in terms of high density lipoprotein cholesterol (HDL C)|Samples taken at Day 42 (week 6) and Day 84 (week 12)|||mg/dL||Standard Deviation|Mean
643894|NCT02226198|Secondary|ApoB (g/L)|Efficacy in terms of apolipoprotein B (ApoB)|Samples taken at Day 42 (week 6) and Day 84 (week 12)|||g/L||Standard Deviation|Mean
643895|NCT02226198|Secondary|ApoB (mg/dL)|Efficacy in terms of apolipoprotein B (ApoB)|Samples taken at Day 42 (week 6) and Day 84 (week 12)|||mg/dL||Standard Deviation|Mean
643896|NCT02226198|Secondary|Non-HDL C (mmol/L)|Efficacy in terms of non-high density lipoprotein cholesterol (non-HDL C)|Samples taken at Day 42 (week 6) and Day 84 (week 12)|||mmol/L||Standard Deviation|Mean
643897|NCT02226198|Secondary|Non-HDL C (mg/dL)|Efficacy in terms of non-high density lipoprotein cholesterol (non-HDL C)|Samples taken at Day 42 (week 6) and Day 84 (week 12)|||mg/dL||Standard Deviation|Mean
643898|NCT02226198|Secondary|TC (mmol/L)|Efficacy in terms of total cholesterol (TC)|Samples taken at Day 42 (week 6) and Day 84 (week 12)|||mmol/L||Standard Deviation|Mean
643899|NCT02226198|Secondary|TC (mg/dL)|Efficacy in terms of total cholesterol (TC)|Samples taken at Day 42 (week 6) and Day 84 (week 12)|||mg/dL||Standard Deviation|Mean
643900|NCT02226198|Primary|LDL-Cholesterol (mmol/L)|Change in low density lipoprotein cholesterol (LDL C) following 6 weeks of rosuvastatin 20 mg compared to 6 weeks of placebo treatment|Samples taken on Day 42 (week 6) and on day 84 (week 12)|6-17 years HoFH||mmol/L||Standard Deviation|Mean
643901|NCT02226198|Primary|LDL-Cholesterol (mg/dL)|Change in low density lipoprotein cholesterol (LDL C) following 6 weeks of rosuvastatin 20 mg compared to 6 weeks of placebo treatment|Samples taken on Day 42 (week 6) and on day 84 (week 12)|6-17 years HoFH||mg/dL||Standard Deviation|Mean
643912|NCT02225860|Secondary|Change in Total Daily Urinary Solutes From Baseline to Week 2|"Total daily urinary solutes (this will serve as a surrogate for diet adherence and is known to be associated with lower vasopressin secretion).
Total daily solutes is the total amount of osmoles detected in 24 hours urine collection."|Baseline to week 2|||mOsm/Day||Standard Deviation|Mean
643913|NCT02225860|Primary|Change in Mean Serum Copeptin From Baseline (a Reflection of Endogenous Vasopressin Production) at Week 2|The copeptin level will reflect the combined effect of low osmolar diet and adjusted water intake at week 2|Baseline to week 2|||pmole/L||Standard Deviation|Mean
643902|NCT02226003|Secondary|Change From Baseline in Sitting Diastolic Blood Pressure at Week 26 - Full Analysis Set Excluding Rescue Approach|Blood pressure measurements were taken after at least 5 minutes of rest. Three measurements were taken approximately 2 minutes apart with the triplicate set recorded. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.|Baseline and Week 26|The FAS population included all randomized participants who took at least 1 dose of study medication and had at least one assessment at or after baseline for the change from baseline in the Week 26 sitting diastolic blood pressure endpoint.||millimeters of mercury||95% Confidence Interval|Least Squares Mean
643903|NCT02226003|Secondary|Change From Baseline in Sitting Systolic Blood Pressure at Week 26 - Full Analysis Set Excluding Rescue Approach|Blood pressure measurements were taken after at least 5 minutes of rest. Three measurements were taken approximately 2 minutes apart with the triplicate set recorded. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.|Baseline and Week 26|FAS population included all randomized participants who took at least 1 dose of study medication and had at least one assessment at or after baseline for the change from baseline in the Week 26 sitting systolic blood pressure endpoint.||millimeters of mercury||95% Confidence Interval|Least Squares Mean
643904|NCT02226003|Secondary|Change From Baseline in Body Weight at Week 26 - Full Analysis Set Excluding Rescue Approach|Body weight was measured using a standardized, digital scale at each of the pre-defined nominal time points. Weight was taken in duplicate throughout the trial at approximately the same time of day, after voiding (i.e., forced void) and while wearing only a gown and underwear. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.|Baseline and Week 26|FAS population is all randomized participants who took at least 1 dose of study medication and had at least one assessment at or after baseline for the change from baseline in the Week 26 body weight endpoint.||Kilograms||95% Confidence Interval|Least Squares Mean
643905|NCT02226003|Secondary|Percentage of Participants With HbA1C <7% (<53 mmol/Mol) at Week 26|HbA1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). HbA1c represents the percentage of glycated hemoglobin.|Week 26|FAS population includes randomized participants who took at least 1 dose of study medication and had at least one assessment at or after baseline in the Week 26 HbA1C endpoint.||Percentage of participants|||Number
643906|NCT02226003|Secondary|Change From Baseline in 2-hour Post-Meal Glucose (PMG) at Week 26 - Full Analysis Set Excluding Rescue Approach|Change from baseline at Week 26 is defined as 2-hour PMG at Week 26 minus 2-hour PMG at Week 0. Two-hour post-meal glucose was measured following a standard meal. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.|Baseline and Week 26|FAS population is all randomized participants who took at least 1 dose of study medication and had at least one assessment at or after baseline for the change from baseline in the Week 26 2-hour PMG endpoint.||milligrams/deciliter||95% Confidence Interval|Least Squares Mean
643907|NCT02226003|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 - Full Analysis Set Excluding Rescue Approach|Blood glucose was measured after a ≥10 hour fast. Blood was drawn at predose on Day 1 and after 26 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 26 minus FPG at baseline). Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.|Baseline and Week 26|FAS population includes randomized participants who took at least 1 dose of study medication and had at least one assessment at or after baseline for the change from baseline in the Week 26 FPG endpoint.||milligrams/deciliter||95% Confidence Interval|Least Squares Mean
643908|NCT02226003|Primary|Percentage of Participants Who Discontinued Study Medication Due to an AE - All Participants as Treated Excluding Rescue Approach|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.|Up to Week 26|ASaT population consisted of all randomized participants who received at least one dose of a study drug.||Percentage of Participants|||Number
643909|NCT02226003|Primary|Percentage of Participants Who Experienced an Adverse Event (AE) - All Participants as Treated Excluding Rescue Approach|An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.|Up to Week 28|All Subjects as Treated (ASaT) population consisted of all randomized participants who received at least one dose of a study drug.||Percentage of Participants|||Number
643910|NCT02226003|Primary|Change From Baseline in Hemoglobin A1C (HbA1C) at Week 26 - Full Analysis Set (FAS Population Excluding Rescue Approach|HbA1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). HbA1C represents the percentage of glycated hemoglobin. A negative number indicates a reduction in HbA1C level. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.|Baseline and Week 26|FAS population includes randomized participants who took at least 1 dose of study medication and had at least one assessment at or after baseline for the change from baseline in the Week 26 HbA1C endpoint.||Percentage||95% Confidence Interval|Least Squares Mean
643911|NCT02225860|Secondary|Change in Mean Serum Copeptin Level From Baseline to Week 1|Mean serum copeptin level at week one which will reflect the effect of low osmolar diet alone.|baseline to week 1|At week 1, there was a nonsignificant (t-test) increase in plasma copeptin to 7.1 ±5.6 in the low osmolar diet group and to 6.1 ±5.5 in the control group. The change in mean plasma copeptin level between baseline and week1 was not statistically significant between groups.||pmol/L||Standard Deviation|Mean
643914|NCT02224820|Secondary|Pharmacokinetics|IdeS T1/2 in alpha phase. One patient who interrupted dose was excluded.|Up to 21 days|||h||Inter-Quartile Range|Mean
643918|NCT02224820|Primary|Efficacy|Efficacy was defined as the IdeS dosing scheme in the majority of the patients resulting in human leucocyte antigen (HLA) antibody levels which are acceptable for transplantation, measured as mean fluorescent intensity (MFI) of less than 1100, within 24 hours from dosing. MFI was determined by single antigen bead (SAB) assay and detection of complement fixating ability (CIq Screen) in serum.|24 hours|||MFI||Inter-Quartile Range|Mean
643919|NCT02224664|Secondary|Ratio of Accumulation for Area Under the Curve From Time Zero to End of Dosing Interval of PF-06649751|Rac was obtained from AUCtau after last dose divided by AUCtau after first dose, where AUC(tau) = Area under the concentration curve from time zero to end of dosing interval (AUCtau), where dosing interval was 12 hours.|Pre-dose on Day 3, 4, 8, 11, 14, 17, 20, Pre-dose, 0.5, 1, 1.5, 2, 4, 8 and 12 hour post-dose on Day 7, 13, 22|Data was not collected since this outcome measure was not planned to be analyzed.|||||
643920|NCT02224664|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) of PF-06649751||Pre-dose on Day 3, 4, 8, 11, 14, 17, 20, Pre-dose, 0.5, 1, 1.5, 2, 4, 8 and 12 hour post-dose on Day 7, 13, 22|The PF-06649751 PK parameter analysis set included all participants treated and who had at least 1 of the PK parameters of interest in at least 1 treatment period during period 2. Here, ‘n’ signifies those participants who were evaluable at specified time point for each reporting arm, respectively.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
643921|NCT02224664|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval of PF-06649751|Area under the concentration curve from time zero to end of dosing interval (AUCtau), where dosing interval was 12 hours.|Pre-dose on Day 3, 4, 8, 11, 14, 17, 20, Pre-dose, 0.5, 1, 1.5, 2, 4, 8 and 12 hour post-dose on Day 7, 13, 22|The PF-06649751 PK parameter analysis set included all participants treated and who had at least 1 of the PK parameters of interest in at least 1 treatment period during period 2. Here, ‘n’ signifies those participants who were evaluable at specified time point for each reporting arm, respectively.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
643922|NCT02224664|Secondary|Apparent Clearance (CL/F) of PF-06649751|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Pre-dose, 0.5, 1, 1.5, 2, 4, 8 and 12 hour post-dose on Day 22|The PF-06649751 PK parameter analysis set included all participants treated and who had at least 1 of the PK parameters of interest in at least 1 treatment period during period 2. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure.||L/hr||Geometric Coefficient of Variation|Geometric Mean
643923|NCT02224664|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06649751||Pre-dose on Day 3, 4, 8, 11, 14, 17, 20, Pre-dose, 0.5, 1, 1.5, 2, 4, 8 and 12 hour post-dose on Day 7, 13, 22|The PF-06649751 PK parameter analysis set included all participants treated and who had at least 1 of the PK parameters of interest in at least 1 treatment period during period 2. Here, ‘n’ signifies those participants who were evaluable at specified time point for each reprting arm, respectively.||hour||Full Range|Median
643924|NCT02224664|Secondary|Maximum Observed Plasma Concentration (Cmax) of PF-06649751||Pre-dose on Day 3, 4, 8, 11, 14, 17, 20, Pre-dose, 0.5, 1, 1.5, 2, 4, 8 and 12 hour post-dose on Day 7, 13, 22|The PF-06649751 PK parameter analysis set included all participants treated and who had at least 1 of the PK parameters of interest in at least 1 treatment period during period 2. Here, ‘n’ signifies those participants who were evaluable at specified time points for each reporting arm, respectively.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
643925|NCT02224664|Secondary|Apparent Volume of Distribution (Vz/F) of L-Dopa|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|Pre-dose, 0.5, 1, 2, 4 and 8 hours post-dose on Day 1|The L-Dopa PK parameter analysis set included all participants who received at least 1 dose of L-Dopa in open label Period 1 with at least 1 of the PK parameters of interest. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.||Liter (L)||Geometric Coefficient of Variation|Geometric Mean
643926|NCT02224664|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration of L-Dopa|Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (C last).|Pre-dose, 0.5, 1, 2, 4 and 8 hours post-dose on Day 1|The L-Dopa PK parameter analysis set included all participants who received at least 1 dose of L-Dopa in open label Period 1 with at least 1 of the PK parameters of interest.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
643927|NCT02224664|Secondary|Area Under the Curve From Time Zero Extrapolated to Infinite Time of L-Dopa|AUC (0 - inf)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf).|Pre-dose, 0.5, 1, 2, 4 and 8 hours post-dose on Day 1|The L-Dopa PK parameter analysis set included all participants who received at least 1 dose of L-Dopa in open label Period 1 with at least 1 of the PK parameters of interest. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.||nanogram*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
643928|NCT02224664|Secondary|Terminal Half-Life (t1/2) of L-Dopa|Terminal half-life is the time measured for the plasma concentration of drug to decrease by one half. It was calculated as dividing the natural logarithm to the base e (Log e)*2/k el, where k el is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.|Pre-dose, 0.5, 1, 2, 4 and 8 hours post-dose on Day 1|The L-Dopa PK parameter analysis set included all participants who received at least 1 dose of L-Dopa in open label Period 1 with at least 1 of the PK parameters of interest. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.||hour||Standard Deviation|Mean
643956|NCT02224053|Secondary|Tmax|Assessment of the PK of AZD9291 (parent compound), AZ5104 (metabolite) and AZ7550 (metabolite) using time to reach maximum plasma concentration, tmax|PK samples collected in both period 1 and 2 at pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours post AZD9291 dose.|Pharmacokinetic population - all subjects who received at least 1 dose of AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product||h||Full Range|Median
643929|NCT02224664|Secondary|Apparent Clearance (CL/F) of L-Dopa|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Pre-dose, 0.5, 1, 2, 4 and 8 hours post-dose on Day 1|The L-Dopa PK parameter analysis set included all participants who received at least 1 dose of L-Dopa in open label Period 1 with at least 1 of the PK parameters of interest. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure.||liter per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
643930|NCT02224664|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of L-Dopa||Pre-dose, 0.5, 1, 2, 4 and 8 hours post-dose on Day 1|The L-Dopa PK parameter analysis set included all participants who received at least 1 dose of L-Dopa in open label Period 1 with at least 1 of the PK parameters of interest.||hour||Full Range|Median
643931|NCT02224664|Secondary|Maximum Observed Plasma Concentration (Cmax) of L-Dopa||Pre-dose, 0.5, 1, 2, 4 and 8 hours post-dose on Day 1|The L-Dopa pharmacokinetic (PK) parameter analysis set included all participants who received at least 1 dose of L-Dopa in open label Period 1 with at least 1 of the PK parameters of interest.||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
643932|NCT02224664|Primary|Change From Baseline in Parkinson’s Disease Diary For Participants With Motor Fluctuations at Day 20|According to Parkinson’s disease diaries of participants “OFF” time was a time period when the medication no longer providing benefit with regard to mobility, slowness, and stiffness and participants experienced relatively poor overall function with worsening of tremor, rigidity, balance, or bradykinesia. “ON” time was a time period when medication was providing benefit with regard to mobility, slowness, and stiffness. “ON” time was classified as associated with or without troublesome dyskinesia (TD) that interfere with activities of daily living and with or without dyskinesia. “OFF” time and “ON” time with TD were generally considered to be “bad time” with regard to motor function, whereas “ON” time without dyskinesia (WD) and with non- troublesome dyskinesia (NTD) were generally considered to be “good time”.|Baseline, Day 20|Safety analysis set included all participants who received at least 1 dose of study medication(L-Dopa or PF-06649751) in Period 2. Here,‘n’ signifies those participants who were evaluable at specified time points for each reporting arm. This outcome measure was not planned to be assessed in lead-in period (L-dopa).||hour||Standard Deviation|Mean
643933|NCT02224664|Primary|Change From Baseline in Parkinson’s Disease Diary For Participants With Motor Fluctuations at Day 13|According to Parkinson’s disease diaries of participants “OFF” time was a time period when the medication no longer providing benefit with regard to mobility, slowness, and stiffness and participants experienced relatively poor overall function with worsening of tremor, rigidity, balance, or bradykinesia. “ON” time was a time period when medication was providing benefit with regard to mobility, slowness, and stiffness. “ON” time was classified as associated with or without troublesome dyskinesia (TD) that interfere with activities of daily living and with or without dyskinesia. “OFF” time and “ON” time with TD were generally considered to be “bad time” with regard to motor function, whereas “ON” time without dyskinesia (WD) and with non- troublesome dyskinesia (NTD) were generally considered to be “good time”.|Baseline, Day 13|Safety analysis set included all participants who received at least 1 dose of study medication(L-Dopa or PF-06649751) in Period 2. Here,‘n’ signifies those participants who were evaluable at specified time points for each reporting arm.This outcome measure was not planned to be assessed in lead-in period (L-dopa).||hour||Standard Deviation|Mean
643934|NCT02224664|Primary|Number of Participants With Categorical Scores on The Columbia Suicide Severity Rating Scale (C-SSRS)|The C-SSRS was an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior. C-SSRS assessed whether participant experienced any of the following 1: completed suicide, 2: suicide attempt (response of “yes” on “actual attempt”), 3: preparatory acts toward imminent suicidal behavior (“yes” on “aborted attempt”, “interrupted attempt”, “preparatory acts or behavior”), 4: any suicidal behavior or ideation, suicidal ideation (“yes” on “wish to be dead”, “non-specific active suicidal thoughts”, “active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent”), 7: self-injurious behavior, no suicidal intent (“yes” on “has participant engaged in non-suicidal self-injurious behavior”).|Baseline up to Day 30|Safety analysis set included all participants who received at least 1 dose of study medication (L-Dopa or PF-06649751) in Period 2. This outcome measure was not planned to be assessed in lead-in period (L-dopa).||participants|||Number
643935|NCT02224664|Primary|Number of Participants With Clinically Significant Neurological Examination Abnormality|The complete or full neurological examination included assessment of the cranial nerves; muscle strength, tone, cortical drift, abnormal movements; deep tendon reflexes; sensory exam, coordination, gait and station. Higher cortical and motor function was considered part of the complete neurological exam. Findings were considered abnormal as confirmed by a certified neurologist.|Baseline up to Day 30|Safety analysis set included all participants who received at least 1 dose of study medication (L-Dopa or PF-06649751) in Period 1 and/or Period 2.||participants|||Number
643936|NCT02224664|Primary|Number of Participants With Clinically Significant Change From Baseline in Physical Examination Findings|Physical examination included examination of the head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. The examination assessed the participants for any potential changes in general appearance, the respiratory and cardiovascular systems, as well as towards participant reported symptoms. Findings were considered to be clinically significant based on investigator’s decision.|Baseline up to Day 30|Safety analysis set included all participants who received at least 1 dose of study medication (L-Dopa or PF-06649751) in Period 1 and/or Period 2.||participants|||Number
643957|NCT02224053|Secondary|AUC(0-72)|Assessment of the PK of AZD9291 (parent compound), AZ5104 (metabolite) and AZ7550 (metabolite) using area under the plasma concentration curve from time zero to 72 hours, AUC(0-72)|PK samples collected in both period 1 and 2 at pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours post AZD9291 dose.|Pharmacokinetic population - all subjects who received at least 1 dose of AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product||nM.h||Full Range|Geometric Mean
643937|NCT02224664|Primary|Number of Participants With Electrocardiogram (ECG) Abnormalities|Criteria for ECG abnormalities: maximum PR interval >=300 milliseconds (msec) and maximum increase PR interval increase from baseline (IFB): percent change (Pctchg) >=25 percent (%) for baseline value of >200 msec and Pctchg>=50% for baseline value of <=200 msec for PR interval, maximum QRS interval >=140 msec and a maximum IFB: Pctchg>=50%, maximum QTCF interval (Fridericia’s Correction) of 450 msec to <480 msec, 480 msec to <500 msec or >=500 msec and a maximum change of <=30change<60 or >=60 msec from baseline.|Baseline up to Day 30|Safety analysis set included all participants who received at least 1 dose of study medication (L-Dopa or PF-06649751) in Period 1 and/or Period 2. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.||participants|||Number
643938|NCT02224664|Primary|Number of Participants With Vital Sign Abnormalities|Criteria for vital sign abnormality included supine pulse rate of <40 beats per minute (bpm) or >120 bpm, standing pulse rate of <40 bpm or >140 bpm, supine and standing systolic blood pressure (SBP) <90 millimeter of mercury (mmHg), supine and standing diastolic blood pressure (DBP) <50 mmHg, supine and standing SBP of >=30 mmHg maximum (max.) increase from baseline (IFB) and and decrease from baseline (DFB) in same posture, supine and Standing DBP of >=20 mmHg max. increase and decrease from baseline in same posture. Categories in which there was atleast 1 abnormality are reported in this outcome measure.|Baseline up to Day 30|Safety analysis set included all participants who received at least 1 dose of study medication (L-Dopa or PF-06649751) in Period 1 and/or Period 2. Here, ‘n’ signifies the number of participants evaluable for the specific category.||participants|||Number
643939|NCT02224664|Primary|Number of Participants With Laboratory Test Abnormalities|Criteria for laboratory abnormalities: Hemoglobin (Hgb),hematocrit, red blood cell(RBC) count: less than(<)0.8*lower limit of normal(LLN),mean corpuscular Hgb, mean corpuscular volume, mean corpuscular Hgb concentration:<0.9*LLN, greater than (>)1.1*upper limit of normal(ULN),platelet:<0.5*LLN,>1.75*ULN,lymphocyte,neutrophil:<0.8*LLN, >1.2*ULN, basophil, eosinophil, monocyte:>1.2*ULN, WBC:<0.6*LLN, >1.5*ULN;total bilirubin>1.5*ULN, aspartate aminotransferase,alanine aminotransferase,alkaline phosphatase:>3.0*ULN,total protein,albumin:<0.8*LLN,>1.2*ULN;blood urea nitrogen,creatinine:>1.3*ULN, uric acid>1.2*ULN;sodium<0.95*LLN,>1.05*ULN,potassium,chloride,calcium,bicarbonate:<0.9*LLN,>1.1*ULN;glucose<0.6*LLN,>1.5*ULN,urine pH:<4.5, >8; urine: WBC, RBC greater than or equal to (>=)20/high performance field, bacteria: >20; urobilinogen, urine: glucose, ketone, protein, Hgb, nitrite, leukocyte esterase, bilirubin: >=1.|Baseline up to Day 30|Safety analysis set included all participants who received at least 1 dose of study medication (L-Dopa or PF-06649751) in Period 1 and/or Period 2. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.||participants|||Number
643940|NCT02224664|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; Initial or prolonged in-patient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug to the end of study (up to Day 30) that were absent before treatment or that worsened relative to pre-treatment state. AEs included both serious and non-serious adverse events.|Baseline (Day 1) up to Day 30|Safety analysis set included all participants who received at least 1 dose of study medication (L-Dopa or PF-06649751) in Period 1 and/or Period 2.||participants|||Number
643941|NCT02224625|Primary|Grading Scale for Visual Evaluation of Skin Condition|"Irritation: 21 days of patching (total). A reviewer will assign a score based on an 8 point categorical scale to the areas treated at each visit.
Sensitization: 35 days (21 days of patching followed by 14 days rest and subsequent patch). A reviewer will assign a score based on an 8 point categorical scale to the areas treated at each visit. SLS was not tested.
Grade 0 = No irritation Grade 1 = Minimal erythema Grade 2 = Definite erythema Grade 3 = Erythema and papules Grade 4 = Edema Grade 5 = Erythema, edema and papules Grade 6 = Vesicular eruption Grade 7 = Strong reaction spreading"|21 Days for Irritation (N=39). 35 Days for Sensitization (N=249)|Participants received more than one product at a time.||Scores Ranging (0-7)||Full Range|Mean
643942|NCT02224508|Secondary|Depressive Symptoms|Patient Health Questionnaire (PHQ-8) depression scale. The PHQ-8 is estimated by summing the 8 scale items. The total score ranges from 0 to 24, with higher scores indicating greater depression severity. Estimates were weighted to account for non-response, with weights based on baseline patient characteristics assessed with electronic health care data available for all chronic opioid therapy patients sampled for the survey. The number analyzed differs from the Participant Flow module due to persons with missing item data who were dropped from this analysis. The numbers with missing items were deemed too few to justify item imputation.|2 weeks prior to interview|||units on a scale||95% Confidence Interval|Mean
643943|NCT02224508|Secondary|Pain Severity (Intensity, Interference With Activities, Enjoyment): PEG Scale|PEG (Pain - Enjoyment - Interference with General Activities) pain scale consisting of the average of 3 0-10 ratings of pain intensity, interference with activities due to pain, and reduced enjoyment of life due to pain. Estimates were weighted to account for non-response, with weights based on baseline patient characteristics assessed with electronic health care data available for all chronic opioid therapy patients sampled for the survey. The PEG score ranges from 0 to 30, with higher scores indicating greater pain severity. The number analyzed differs from the Participant Flow module due to persons with missing item data who were dropped from this analysis. The numbers with missing items were deemed too few to justify item imputation.|1 week prior to interview|||units on a scale||95% Confidence Interval|Mean
643958|NCT02224053|Secondary|AUC(0-t)|Assessment of the PK of AZD9291 (parent compound), AZ5104 (metabolite) and AZ7550 (metabolite) using area under the plasma concentration curve from zero extrapolated to o the time of the last quantifiable concentration, AUC(0-t)|PK samples collected in both period 1 and 2 at pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours post AZD9291 dose.|Pharmacokinetic population - all subjects who received at least 1 dose of AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product||nM.h||Full Range|Geometric Mean
644018|NCT02223364|Secondary|Average Pain POD 1 (24 Hours)|Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.|POD 1, approximately 12 am to 12 am next day|Intent-to-Treat Analysis||units on a scale||Inter-Quartile Range|Median
643944|NCT02224508|Primary|Proportion With Prescription Opioid Use Disorder (Defined by DSM5 Criteria).|Proportion with Prescription Opioid Use Disorder, which is defined by multiple indicators of opioid abuse and addiction from 9 criteria in the DSM5 manual of the American Psychiatric Association. In this research, it will be assessed using the Psychiatric Research Interview for Substance and Mental Disorders (PRISM5, Columbia University). Estimates were weighted to account for non-response, with weights based on baseline patient characteristics assessed with electronic health care data available for all chronic opioid therapy patients sampled for the survey. The number analyzed differs from the Participant Flow module due to persons with missing item data who were dropped from this analysis. The numbers with missing items were deemed too few to justify item imputation.|1 year prior to interview|Prevalent chronic opioid therapy (COT) patients defined as having received at least 70 days supply of opioids in the 90 days prior to sample selection, at least 70 days supply of opioids in at least one of the 3 other quarters in the preceding year, and at least 45 days supply of opioids in the other two quarters.||proportion of COT patients||95% Confidence Interval|Number
643945|NCT02224404|Secondary|Evaluate the Level of Pain at Week 6 Changes in Wound Status, Clinician's and Subject's Opinion, and Technical Performance|Pain during product removal at week 6, measured by Visual Analog scale.This will be measured by the following variables; visual analog scale, 0=no pain, 100= worst pain, scale from 0-100 mm|6 weeks|||units on a scale||Inter-Quartile Range|Median
643946|NCT02224404|Primary|Number of Participants With Worsening in Peri-Skin Wound.(Maceration From Baseline to 6 Weeks)|the subjects will be measured by the following variables; maceration,|6 weeks|||participants|||Number
643947|NCT02224053|Secondary|Parent to Metabolite Ratios of AZ5104 and AZ7550 AUC|Assessment of the PK of AZ5104 and AZ7550 AUC using the parent (AZD9291) to metabolite ratios|PK samples collected in both period 1 and 2 at pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours post AZD9291 dose.|Pharmacokinetic population - all subjects who received at least 1 dose of AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product||Ratio||Full Range|Geometric Mean
643948|NCT02224053|Secondary|Parent to Metabolite Ratios of AZ5104 and AZ7550 Cmax|Assessment of the PK of AZ5104 and AZ7550 Cmax using the parent (AZD9291) to metabolite ratios|PK samples collected in both period 1 and 2 at pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours post AZD9291 dose.|Pharmacokinetic population - all subjects who received at least 1 dose of AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product||Ratio||Full Range|Geometric Mean
643949|NCT02224053|Secondary|AUC of AZ5104 and AZ7550|Area under the plasma concentration-time curve from zero to infinity of AZ5104 and AZ7550 (metabolites to AZD9291)|PK samples collected in both period 1 and 2 at pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours post AZD9291 dose.|Pharmacokinetic population - all subjects who received at least 1 dose of AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product||nM.h||Full Range|Geometric Mean
643950|NCT02224053|Secondary|Cmax of AZ5104 and AZ7550|Assessment of the PK of AZ5104 and AZ7550 (metabolites to AZD9291) using the maximum plasma concentration, Cmax|PK samples collected in both period 1 and 2 at pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours post AZD9291 dose.|Pharmacokinetic population - all subjects who received at least 1 dose of AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product||nM||Full Range|Geometric Mean
643951|NCT02224053|Secondary|Vz/F of AZD9291|Assessment of the PK of AZD9291 using the apparent volume of distribution, Vz/F|PK samples collected in both period 1 and 2 at pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours post AZD9291 dose.|Pharmacokinetic population - all subjects who received at least 1 dose of AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product||L||Full Range|Geometric Mean
643952|NCT02224053|Secondary|CL/F of AZD9291|Assessment of the PK of AZD9291 using the apparent plasma clearance, CL/F|PK samples collected in both period 1 and 2 at pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours post AZD9291 dose.|Pharmacokinetic population - all subjects who received at least 1 dose of AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product||L/h||Full Range|Geometric Mean
643953|NCT02224053|Secondary|λz|Assessment of the PK of AZD9291 (parent compound), AZ5104 (metabolite) and AZ7550 (metabolite) using the terminal rate constant, λz|PK samples collected in both period 1 and 2 at pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours post AZD9291 dose.|Pharmacokinetic population - all subjects who received at least 1 dose of AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product||1/h||Full Range|Geometric Mean
643954|NCT02224053|Secondary|t(1/2)|Assessment of the PK of AZD9291 (parent compound), AZ5104 (metabolite) and AZ7550 (metabolite) using the terminal half-life, t(1/2)|PK samples collected in both period 1 and 2 at pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours post AZD9291 dose.|Pharmacokinetic population - all subjects who received at least 1 dose of AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product||h||Full Range|Geometric Mean
643955|NCT02224053|Secondary|Tlag|Assessment of the PK of AZD9291 (parent compound), AZ5104 (metabolite) and AZ7550 (metabolite) using lag time before observation of quantifiable analyte concentrations in plasma, tlag|PK samples collected in both period 1 and 2 at pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours post AZD9291 dose.|Pharmacokinetic population - all subjects who received at least 1 dose of AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product||h||Full Range|Median
644019|NCT02223364|Secondary|Maximum Pain Post-PACU|Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.|Post-operative Day 0, approximately 12 pm to 12 am|Intent-to-Treat Analysis||units on a scale||Inter-Quartile Range|Median
643959|NCT02224053|Primary|Cmax of AZD9291|Rate and extent of absorption of AZD9291 following single oral doses of AZD9291 tablet formulation by assessment of maximum plasma concentration (Cmax).|PK samples collected in both period 1 and 2 at pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours post AZD9291 dose.|Pharmacokinetic population - all subjects who received at least 1 dose of AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product||nM||Full Range|Geometric Mean
643960|NCT02224053|Primary|AUC of AZD9291|Area under the plasma concentration-time curve from zero to infinity for AZD9291|PK samples collected in both period 1 and 2 at pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours post AZD9291 dose|Pharmacokinetic population - all subjects who received at least 1 dose of AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product||nM.h||Full Range|Geometric Mean
643961|NCT02223871|Post-Hoc|Drug-specific Parasite Reduction Ratio (PRR48) of ACT-451840 Over 48 Hours Using a New Approach|"After the blood stage Plasmodium falciparum challenge (BSPC), malaria parasitemia was measured by polymerase chain reaction (PCR) in regularly collected blood samples.
The subject-specific and drug-specific parasite reduction rates over a 48 h period (PRR48) were calculated following the data-driven method by Marquart et al. (2015), removing potential lag and tail phases prior to log-linear regression modeling."|48 hours after study drug administration|Only subjects with appropriate overall fit (p-value of the overall model F-test <0.001) were taken into account (n = 8 with the method described by Marquart et al., 2015)||Ratio||95% Confidence Interval|Mean
643962|NCT02223871|Secondary|Change From Baseline in Respiratory Rate to End of Study (EOS)||Day 28 (EOS)|||Breaths/min||Full Range|Median
643963|NCT02223871|Secondary|Change From Baseline in Body Temperature up to End of Study (EOS)|Body temperature was measured orally|Day 28 (EOS)|||Degree Celsius||Full Range|Median
643964|NCT02223871|Secondary|Change From Baseline in Blood Pressure to End of Study (EOS)|Vital signs, including diastolic and systolic blood pressure (DBP/SBP), were measured at each outpatient visit up to 7 days after ACT-451840 administration, every day during confinement or when malaria symptoms were presented and at the end of study visit (EOS). Other measures were performed if required.|Day 28 (EOS)|||mmHg||Full Range|Median
643965|NCT02223871|Secondary|Terminal Half-life [t(1/2)]|Blood samples for pharmacokinetic characterization were drawn at pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 48, 72, 96, and 144 hours post-dose|From pre-dose to144 hours after study drug adminsitration|Per protocol set||Hours||95% Confidence Interval|Geometric Mean
643966|NCT02223871|Secondary|Areas Under the Plasma Concentration-time Curve of ACT-451840|"Two AUCs were calculated using non-compartmental analysis: AUC(0-t) from pre-dose to last time-point of measure and AUC(0-inf) from pre-dose and extrapolated to infinity.
Blood samples for pharmacokinetic characterization were drawn at pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 48, 72, 96, and 144 hours post-dose"|From pre-dose to144 hours after study drug administration|||ng*h/mL||95% Confidence Interval|Geometric Mean
643967|NCT02223871|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of ACT-451840|tmax was directly derived from the plasma concentration-time curves of ACT-451840. Blood samples for pharmacokinetic characterization were drawn at pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 48, 72, 96, and 144 hours post-dose.|From pre-dose to144 hours after study drug administration|||Hours||Full Range|Median
643968|NCT02223871|Secondary|Maximum Plasma Concentration (Cmax) of ACT-451840|Cmax was directly derived from the plasma concentrations-time curves of ACT-451840. Blood samples for pharmacokinetic characterization were drawn at pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 48, 72, 96, and 144 hours post-dose.|From pre-dose to 144 hours after study drug adminsitration|||ng/mL||95% Confidence Interval|Geometric Mean
643969|NCT02223871|Primary|Drug-specific Parasite Reduction Ratio (PRR48) of ACT-451840 Over 48 Hours Using a Standardized Approach|"After the blood stage Plasmodium falciparum challenge (BSPC), malaria parasitemia was measured by polymerase chain reaction (PCR) in regularly collected blood samples.
The subject-specific and drug-specific parasite reduction rates over a 48 h period (PRR48) were calculated using an objective standardized approach (observed data over 48 h)"|48 hours after study drug administration|Only subjects with appropriate overall fit (p-value of the overall model F-test <0.001) were taken into account (n = 5)||Ratio||95% Confidence Interval|Mean
643970|NCT02223754|Primary|Contact Lens Fitting|Contact Lens fitting is reported as a binary response. Yes- acceptable lens fit, No- unacceptable lens fit. The percentage of subject eyes with acceptable fit is reported.|8- 12 Days post wear|The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes.||Percentage of Subject Eyes|Participants||Number
643971|NCT02223754|Primary|Limbal Conjunctival Injection|The Limbus is the 1 to 2mm wide zone of conjunctiva and underlying tissue adjacent to where the cornea joins the sclera. Limbal Conjunctival Injection was assesed using the Efron grading scale in 1 unit increments. Grade 0: Normal, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate, Grade 4:Severe. The data was dichotomized into two group subjects with grade 3 or higher Conjunctival injection, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens.|8- 12 Days post wear|The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes.||Percentage of Subject Eyes|Participants||Number
643972|NCT02223754|Primary|Bulbar Conjunctival Injection|The bulbar is the scelra. Bulbar Conjunctival Injection was assessed using an Efron Grading scale by 1 unit increments. Grade 0: Normal, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate, Grade 4:Severe. The data was dichotomized into two group subjects with grade 3 or higher Conjunctival injection, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens.|8- 12 Days post wear|The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes.||Percentage of Subject Eyes|Participants||Number
644015|NCT02223364|Secondary|Maximum Pain POD 2 (24 Hours)|Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.|POD 2, approximately 12 am to 12 am next day|Intent-to-Treat Analysis. For POD 2, data are missing for 5 subjects (1 on PNB arm, 1 on PAI-R arm, and 3 on PAI-L arm).||units on a scale||Inter-Quartile Range|Median
643973|NCT02223754|Primary|Corneal Staining|Corneal staining is evaluated using Sodium Fluorescein strips. The Fluorescien strip was lightly placed on the subject’s inferior palpebral conjunctiva. The corneal Staining was graded using the scale Grade 0: No Staining, Grade 1: Trace(Minimal superficial staining or stippling), Grade 2: Mild (Regional or diffuse punctate staining), Grade 3:Moderate(Significant dense coalesced staining, corneal abrasion or foreign body tracks.), Grade 4 Severe(Severe abrasions greater than 2 mm in diameter, ulcerations, epithelial loss, or full thickness abrasion.). The data was dichotomized into two group subjects with grade 3 or higher staining, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens.|8 - 12 Days post wear|The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes.||percentage of Subject Eyes|Participants||Number
643974|NCT02223754|Primary|Near Binocular Visual Acuity (LogMAR)|Near time controlled LogMAR Visual Acuity was carried out binocularly using High lumiance and High Contrast.|8-12 days post wear|The analysis population consists of subjects that completed all study visits without a major protocol deviation.||LogMAR||Standard Deviation|Mean
643975|NCT02223754|Primary|Intermediate Binocular Visual Acuity (LogMAR)|Intermediate time controlled LogMAR Visual Acuity was carried out binocularly using High lumiance and High Contrast.|8-12 days post wear|The analysis population consists of subjects that completed all study visits without a major protocol deviation.||LogMAR||Standard Deviation|Mean
643976|NCT02223754|Primary|Distance Binocular Visual Acuity (LogMAR)|Distance time controlled LogMAR Visual Acuity was carried out binocularly with high luminance and high contrast.|8- 12 Days post wear|The analysis population consists of subjects that have completed all study visits without a major protocol deviation.||LogMAR||Standard Deviation|Mean
643977|NCT02223754|Primary|Overall Quality of Vision Using the Contact Lens User Experience (CLUE) TM Questionnaire|CLUE Overall Quality of Vision is assessed using the Contact Lens User Experience (CLUE)TM questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD).|8 -12 days post wear|The analysis population consists of subjects that completed all study visits without a major protocol deviation.||units on a scale||Standard Deviation|Mean
643978|NCT02223715|Secondary|Recurrence or Not After 2 Months Follow-up|"The patients were observed from the diagnosis to the end of the treatment and got a telephone follow up call after two month from the end of treatment.
Unknown includes patient lost, data missing"|From the time of CDI diagnosis to 2 months follow-up|||participants|||Number
643979|NCT02223715|Secondary|Clinical Complication|This study was non-interventional observational study. There were no restriction on the CDI treatment and we did not define to collect AE data. We just defined to collect the data for complications with CDI treatments indicating below. The complications to be checked were defined in the protocol. The information of other complications and AEs were not collected.|From the time of CDI diagnosis to recovery or recurrence|||participants|||Number
643980|NCT02223715|Primary|Status at the End of CDI Episode|The patients were observed from the diagnosis to the end of the treatment and got a telephone follow up call after two month from the end of treatment. The categories of the status indicating below are at the end of the treatment, not at the follow up call. Lost to follow-up means the patient number who were lost during the treatment course.|From the time of CDI diagnosis to the end of the treatment|||participants|||Number
643981|NCT02223715|Primary|Patient Demographics|Medical history is information which was collected at the CDI diagnosis in this study. The items of the Medical history are indicated below. Concomitant diseases at the CDI diagnosis were included in the Medical history.|At the study at the time of CDI diagnosis enrollment|Medical history is information which was collected at the CDI diagnosis in this study. The items of the Medical history are indicated below. Concomitant diseases at the CDI diagnosis were included in the Medical history.||participants|||Number
643982|NCT02223650|Secondary|Proportion of Subjects With Near Control Treatment Response|"A comparison of the proportion of subjects showing a treatment response, defined as an improvement of at least 1 point in near control (mean of the 3 assessments over the exam) between enrollment and 8 weeks."|8 weeks|||participants|||Number
643983|NCT02223650|Secondary|Symptom Survey Response to Question: Has Your Child Reported Blurry Vision?|A brief survey of symptoms that may be associated with overminus such as headaches, eye strain, and problems with spectacle wear will be administered to the parents of the subjects. Parents are asked to respond to the survey questions based on their observations of their child in the past 2 weeks. Response options are based on frequency of observations; never, rarely, sometimes, often, always, and not applicable. Survey items were derived based on expert opinion of pediatric ophthalmologists and optometrists on the study planning committee. The response options were a 5-point Likert-type scale based on frequency of observations: never = score of 0, almost never = 1, sometimes = 2, often = 3, and always = 4.|8 weeks|||participants|||Number
643984|NCT02223650|Secondary|Symptom Survey Response to Question: Since Enrollment Has Your Child Avoided Reading or Doing Things up Close?|A brief survey of symptoms that may be associated with overminus such as headaches, eye strain, and problems with spectacle wear will be administered to the parents of the subjects. Parents are asked to respond to the survey questions based on their observations of their child in the past 2 weeks. Response options are based on frequency of observations; never, rarely, sometimes, often, always, and not applicable. Survey items were derived based on expert opinion of pediatric ophthalmologists and optometrists on the study planning committee. The response options were a 5-point Likert-type scale based on frequency of observations: never = score of 0, almost never = 1, sometimes = 2, often = 3, and always = 4.|8 weeks|Spectacle-related questions at follow up apply only to observation participants prescribed correction (N=10 (32%) and to all overminus group participants N=27 (100%)).||participants|||Number
644016|NCT02223364|Secondary|Average Pain POD 2 (24 Hours)|Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.|POD 2, approximately 12 am to 12 am next day|Intent-to-Treat Analysis. For POD 2, data are missing for 5 subjects (1 on Peripheral Nerve Block (PNB) arm, 1 on Ropivacaine (PAI-R) arm, and 3 on Liposomal Bupivacaine (PAI-L) arm).||units on a scale||Inter-Quartile Range|Median
643985|NCT02223650|Secondary|Symptom Survey Response to Question: Has Your Child Had Eyestrain (Tired, Sore, or Uncomfortable Eyes)?|A brief survey of symptoms that may be associated with overminus such as headaches, eye strain, and problems with spectacle wear will be administered to the parents of the subjects. Parents are asked to respond to the survey questions based on their observations of their child in the past 2 weeks. Response options are based on frequency of observations; never, rarely, sometimes, often, always, and not applicable. Survey items were derived based on expert opinion of pediatric ophthalmologists and optometrists on the study planning committee. The response options were a 5-point Likert-type scale based on frequency of observations: never = score of 0, almost never = 1, sometimes = 2, often = 3, and always = 4.|8 weeks|||participants|||Number
643986|NCT02223650|Secondary|Binocular Near Visual Acuity|Binocular near visual acuity was tested in habitual correction using the ATS4 near visual acuity test. The treatment groups were not different with respect to 8-week control at near.|8 weeks|||prism diopters||Standard Deviation|Mean
643987|NCT02223650|Secondary|Distance Visual Acuity|Monocular distance visual acuity testing with the habitual correction and without cycloplegia was measured using the Amblyopia Treatment Study HOTV testing protocol on any certified visual acuity system. The treatment groups were not different with respect to 8-week control PACT at distance|8 weeks|||prism diopters||Standard Deviation|Mean
643988|NCT02223650|Secondary|Stereoacuity|Stereoacuity will be assessed with habitual correction using the Randot Preschool stereotest at near (performed at 40 cm). A specific level of stereoacuity is not required for eligibility.|8 weeks|||log arcsecond||Standard Deviation|Mean
643989|NCT02223650|Secondary|Symptom Survey Response to Question: Has Child Looked Over His/Her Spectacles Since Enrollment?|A brief survey of symptoms that may be associated with overminus such as headaches, eye strain, and problems with spectacle wear will be administered to the parents of the subjects. Parents are asked to respond to the survey questions based on their observations of their child in the past 2 weeks. Response options are based on frequency of observations; never, rarely, sometimes, often, always, and not applicable. Survey items were derived based on expert opinion of pediatric ophthalmologists and optometrists on the study planning committee. The response options were a 5-point Likert-type scale based on frequency of observations: never = score of 0, almost never = 1, sometimes = 2, often = 3, and always = 4.|8 weeks|Spectacle-related questions at follow up apply only to observation participants prescribed correction (N=10 (32%) and to all overminus group participants N=27 (100%)).||participants|||Number
643990|NCT02223650|Secondary|Proportion of Subjects With Distance Control Treatment Response|"A comparison of the proportion of subjects showing a treatment response, defined as an improvement of at least 1 point in distance control (mean of the 3 assessments over the exam) between enrollment and 8 weeks."|8 weeks|||participants|||Number
643991|NCT02223650|Secondary|Distribution of Near Control Score at 8-week Outcome|Control of exodeviation will be assessed in the habitual correction at distance (6 meters) and near (1/3 meter) using a standardized IXT control scale.|8 weeks|||participants|||Number
643992|NCT02223650|Secondary|Distribution of Distance Control Score at 8-week Outcome|Control of exodeviation will be assessed in the habitual correction at distance (6 meters) and near (1/3 meter) using a standardized IXT control scale.|8 weeks|||participants|||Number
643993|NCT02223650|Secondary|Mean Near Exotropia Control Score|"At each visit, control of the exodeviation was measured at near (1/3 meters) using the Office Control Score which ranges from 0 (phoria, best control) to 5 (constant exotropia, worst control). Due to the variability of single measures of control, we used a triple control score, which is a mean of 3 measures obtained at specific time-points during a 20- to 40-minute office examination. The secondary analysis was an intention-to-treat treatment group comparison of mean 8-week near control using an analysis of covariance (ANCOVA) model which adjusted for baseline near control."|8 weeks|||points on control score scale||Standard Deviation|Mean
643994|NCT02223650|Primary|Mean Distance Exotropia Control Score|"At each visit, control of the exodeviation was measured at distance (6 meters) and at near (1/3 meters) using the Office Control Score* which ranges from 0 (phoria, best control) to 5 (constant exotropia, worst control). Due to the variability of single measures of control, we used a “triple control score,” which is a mean of 3 measures obtained at specific time-points during a 20- to 40-minute office examination. The primary analysis was an intention-to-treat treatment group comparison of mean 8-week distance control using an analysis of covariance (ANCOVA) model which adjusted for baseline distance control.
*Mohney BG, Holmes JM. An office-based scale for assessing control in intermittent exotropia. Strabismus 2006;14(3):147-50."|8 weeks|||points on control score scale||Standard Deviation|Mean
643995|NCT02223429|Secondary|Mean Percent Signal Change in Right Lateral Septum|The effect of the drug will be assessed by determining changes in brain activation to own child pictures versus adult pictures (O-A) between AVP treatment and placebo treatments (AVP-PL) from functional magnetic resonance imaging (fMRI). Changes will be assessed in the AVP group only per protocol.|Baseline, Visit 2 (Up to 10 days)|The analysis was conducted in the AVP groups only per protocol. One person from each order of administration were excluded from the analysis due to motion issues in their imaging data.||Percent signal change||Standard Deviation|Mean
643996|NCT02223429|Secondary|Mean Percent Signal Change in Primary Auditory Cortex|The effect of the drug will be assessed by determining changes in brain activation to own child pictures versus adult pictures (O-A) between OT treatment and placebo treatments (OT-PL) from functional magnetic resonance imaging (fMRI). Changes will be assessed in the OT group only per protocol.|Baseline, Visit 2 (Up to 10 days)|The analysis was completed per protocol for the OT + placebo group only.||Percent signal change||Standard Deviation|Mean
643997|NCT02223429|Secondary|Difference in Cry Rating Scores Between AVP and Placebo|"The effect of the drug will be assessed by analyzing the differences between ratings of infant cries under AVP and placebo treatment on a 7-point likert scale. Sixteen adjectives will be used to describe two different cries. Participants will rate each cry from 1-7 where one represents not at all and 7 represents extremely. Difference is defined as AVP minus placebo scores."|Baseline, Visit 2 (Up to 10 days)|Analysis was completed according to protocol for all participants who were administered AVP in combination with placebo at any time point during the study.||units on a scale||Standard Deviation|Mean
644017|NCT02223364|Secondary|Maximum Pain POD 1 (24 Hours)|Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.|POD 1, approximately 12 am to 12 am next day|Intent-to-Treat Analysis||units on a scale||Inter-Quartile Range|Median
643998|NCT02223429|Secondary|Difference in Cry Rating Scores Between OT and Placebo|"The effect of the drug will be assessed by analyzing the differences between ratings of infant cries under OT and placebo treatment on a 7-point likert scale. Sixteen adjectives will be used to describe two different cries. Participants will rate each cry from 1-7 where one represents not at all and 7 represents extremely. Difference is defined as OT minus placebo scores."|Baseline, Visit 2 (Up to 10 days)|Of the 15 participants who were administered oxytocin in combination with placebo at any time point during the study, data were analyzed for 14 participants. One participant was excluded from the analysis due to missing data.||units on a scale||Standard Deviation|Mean
643999|NCT02223429|Secondary|Change in Plasma Levels of Oxytocin (OT)|Peripheral levels of OT will be assessed via assay of plasma collected.|Baseline, Visit 2 (Up to 10 days)|Zero participants were analyzed as samples were not assayed.|||||
644000|NCT02223429|Secondary|Change in Plasma Levels of Vasopressin (AVP)|Peripheral levels of AVP will be assessed via assay of plasma collected.|Baseline, Visit 2 (Up to 10 days)|Zero participants were analyzed as AVP samples were not assayed.|||||
644001|NCT02223429|Primary|Mean Percent Signal Change in the Anterior Cingulate Cortex|The effect of the drug will be assessed by determining changes in brain activation to own child pictures versus adult pictures (O-A) between OT treatment and placebo treatments (OT-PL) from functional magnetic resonance imaging (fMRI).|Baseline, Visit 2 (Up to 10 days)|Analysis was conducted in the OT+placebo groups only.||Percent signal change||Standard Deviation|Mean
644002|NCT02223429|Primary|Mean Percent Signal Change in the Visual Cortex|The effect of the drug will be assessed by determining changes in brain activation to own child pictures versus adult pictures (O-A) between OT treatment and placebo treatments (OT-PL) from functional magnetic resonance imaging (fMRI).|Baseline, Visit 2 (Up to 10 days)|The analysis was completed per protocol for the OT + placebo groups only.||Percent signal change||Standard Deviation|Mean
644003|NCT02223429|Primary|Mean Percent Signal Change in Caudate Nucleus|The effect of the drug will be assessed by determining changes in brain activation to own child pictures versus adult pictures (O-A) between OT treatment and placebo treatments (OT-PL) from functional magnetic resonance imaging (fMRI).|Baseline, Visit 2 (Up to 10 days)|The analysis was completed per protocol for the OT + placebo groups only.||Percent signal change||Standard Deviation|Mean
644004|NCT02223429|Primary|Mean Percent Signal Change in Right Medial Orbitofrontal Cortex|The effect of the drug will be assessed by determining changes in brain activation to own child pictures versus adult pictures (O-A) between OT treatment and placebo treatments (OT-PL) from functional magnetic resonance imaging (fMRI). Changes will be assessed in the OT group only per protocol.|Baseline, Visit 2 (Up to 10 days)|The analysis was completed per protocol for the OT + placebo groups only.||Percent signal change||Standard Deviation|Mean
644005|NCT02223429|Primary|Mean Percent Signal Change in Right Ventral Striatum|The effect of the drug will be assessed by determining changes in brain activation to own child pictures versus adult pictures (O-A) between OT treatment and placebo treatments (OT-PL) from functional magnetic resonance imaging (fMRI). Changes will be assessed in the OT group only per protocol.|Baseline, Visit 2 (Up to 10 days)|The analysis was completed per protocol for the OT + placebo groups only.||Percent signal change||Standard Deviation|Mean
644006|NCT02223429|Primary|Mean Percent Signal Change in Ventral Tegmental Area (VTA)|The effect of the drug will be assessed by determining changes in brain activation to own child pictures versus adult pictures (O-A) between OT treatment and placebo treatments (OT-PL) from functional magnetic resonance imaging (fMRI). Changes will be assessed in the OT group only per protocol.|Baseline, Visit 2 (Up to 10 days)|The analysis was completed per protocol for the OT + placebo groups only.||Percent signal change||Standard Deviation|Mean
644007|NCT02223364|Secondary|Balance Testing on Operative Leg Using Unipedal Stance Time|In order to measure clinical balance, unipedal stance time (UST) was collected as an indicator of balance and fall risk. Timing (in seconds) began upon withdrawal of support and continued until the uplifted foot returned to the floor, the subject required support, or if the subject reached a time limit of 30 seconds. The best performance of three repetitions was recorded for analysis. Normative values for the UST are available. A UST threshold of 30 seconds yields a sensitivity of 95% and a specificity of 58% in identifying those with a history of falls. The first five seconds of unipedal stance is indicative of dynamic balance; inability to maintain unipedal stance for five seconds is a significant predictor of injurious falls.|baseline, approximately 12 weeks|Intent-to-treat analysis||seconds||Inter-Quartile Range|Median
644008|NCT02223364|Secondary|Hospital Length of Stay|The hospital length of stay was measured from the date of admittance until the date of discharge.|Approximately 3 days|Intent-to-treat analysis||days||Inter-Quartile Range|Median
644009|NCT02223364|Secondary|POD 2 Opioid Use|Additional opioid medications that were taken by subjects (recorded at the same time as the time points for measuring pain). Opioid consumption was documented in the patient electronic medical record by the nursing staff caring for the patient.|POD 2, approximately 12 am to 12 am next day|Intent-to-treat analysis. For POD 2, data are missing for 5 subjects (1 on PNB arm, 1 on PAI-R arm, and 3 on PAI-L arm).||mg OME||Inter-Quartile Range|Median
644010|NCT02223364|Secondary|POD 1 Opioid Use|Additional opioid medications that were taken by subjects (recorded at the same time as the time points for measuring pain). Opioid consumption was documented in the patient electronic medical record by the nursing staff caring for the patient.|POD 1, approximately 12 am to 12 am next day|Intent-to-treat analysis||mg OME||Inter-Quartile Range|Median
644011|NCT02223364|Secondary|POD 0 Post-PACU Opioid Use|Additional opioid medications that were taken by subjects (recorded at the same time as the time points for measuring pain). Opioid consumption was documented in the patient electronic medical record by the nursing staff caring for the patient.|POD 0, approximately 12 pm to 12 am|Intent-to-treat||mg OME||Inter-Quartile Range|Median
644012|NCT02223364|Secondary|PACU Opioid Use|Opioid consumption was documented in the patient electronic medical record by the nursing staff caring for the patient.|Approximately 2 hours after entry in PACU|Intent-to-treat analysis||mg OME||Inter-Quartile Range|Median
644013|NCT02223364|Secondary|Intraoperative Opioid Use|Opioid consumption was documented in the patient electronic medical record by the nursing staff caring for the patient.|During the procedure, approximately 2 hours after start of the procedure|Intent-to-treat analysis||mg OME||Inter-Quartile Range|Median
644014|NCT02223364|Secondary|Preoperative Daily Opioid Use|Opioid consumption will be documented in the patient electronic medical record by the nursing staff caring for the patient.|baseline|Intent-to-Treat Analysis||mg oral morphine equivalents (OME)||Inter-Quartile Range|Median
644020|NCT02223364|Secondary|Average Pain Post-Postanesthesia Care Unit (PACU)|Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.|Post-operative Day 0, approximately 12 pm to 12 am|Intent-to-Treat analysis||units on a scale||Inter-Quartile Range|Median
644021|NCT02223364|Primary|Maximum Pain Post-Operative Day (POD) 1 (Morning)|Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.|Post-Operative Day 1, approximately 6 am to 12:00 pm|Intent-to-Treat Analysis||units on a scale||Inter-Quartile Range|Median
644022|NCT02223260|Secondary|Global Assessment of Acceptability and Tolerability of Study Medication|The investigator was to provide a global clinical assessment of tolerability and acceptability of study medication by the patient.This assessment was based on 5-point scale (good, satisfactory, not satisfactory, bad, not assessable).|Day 1 (immediately after dosing)|Treated set||percentage of participants|||Number
644023|NCT02223260|Secondary|Incidence of All AEs During the Treatment Period|Percentage of patients with all adverse events (AEs) during the treatment period (including REP).|Within two days after the administration of trial medication, up to 3 days|Treated set||percentage of participants|||Number
644024|NCT02223260|Secondary|Incidence of All Bleeding Events (Major, CRNM and Minor) During the Treatment Period.|"Percentage of patients with Incidence of all bleeding events(major, clinically relevant non-major (CRNM) & minor) during the treatment period (including the residual effect period).Bleeding events were classified as follow:
Major bleeding: 1) Fatal bleeding 2) Clinically overt bleeding associated with decrease in haemoglobin of at least 2 g/dL (20 g/L) in 24-h-period 3) Bleeding that was retroperitoneal, pulmonary, intracranial, or otherwise involved the central nervous system 4) Bleeding that required surgical intervention in an operating suite. CRNM bleeding: 1) Overt bleeding for which a blood product was administered & which was not directly attributable to the patient’s underlying medical condition 2) Bleeding that required medical or surgical intervention to restore haemostasis, other than in an operating suite. Minor bleeding defined as any overt or macroscopic evidence of bleeding that did not fulfil the criteria for either major bleeding or CRNM bleeding."|Within two days after the administration of trial medication, up to 3 days|Treated set||Percentage of participants|||Number
644025|NCT02223260|Secondary|PK-PD Relationship: Relationship Between Total Dabigatran Plasma Concentration and Coagulation Parameters dTT Values.|Linear regression models were used for modeling the relationship between total dabigatran plasma concentration and coagulation parameters dTT (AntiFactor IIa activity) values. For our simple regression model, R-squared is equal to the square of Pearson’s coefficient of correlation. The R-squared can be between 0 and 1. R-squared =1 means a perfect fit.|baseline (0.5 h before intake of study medication), 2 h, and 12 h after dosing on day 1|PKS||R-Square|||Number
644026|NCT02223260|Secondary|PK-PD Relationship: Relationship Between Total Dabigatran Plasma Concentration and Coagulation Parameters ECT Values.|Linear regression models were used for modeling the relationship between total dabigatran plasma concentration and coagulation parameters ECT values. For our simple regression model, R-squared is equal to the square of Pearson’s coefficient of correlation. The R-squared can be between 0 and 1. R-squared =1 means a perfect fit.|baseline (0.5 h before intake of study medication), 2 h, and 12 h after dosing on day 1|PKS||R-Square|||Number
644027|NCT02223260|Secondary|PK-PD Relationship: Relationship Between Total Dabigatran Plasma Concentration and Coagulation Parameters APTT Values.|Linear regression models were used for modeling the relationship between total dabigatran plasma concentration and coagulation parameters APTT values. For our simple regression model, R-squared is equal to the square of Pearson’s coefficient of correlation. The R-squared can be between 0 and 1. R-squared =1 means a perfect fit.|baseline (0.5 h before intake of study medication), 2 h, and 12 h after dosing on day 1|PKS||R-Square|||Number
644028|NCT02223260|Primary|Central Measurement: The Mean of dTT Ratio at 2h and 12h (+/-2h) Post Administration of Dabigatran Etexilate.|"Central measurement: The mean of dTT (AntiFactor IIa activity) ratio at 2 h and 12 h (±2 h) post administration of dabigatran etexilate. Standard deviation is actually the Coefficient of Variation.
dTT ratio= dTT(post dose)/dTT(baseline). The mean of dTT ratio is presented."|baseline (0.5 h before intake of study medication), 2 h, and 12 h after dosing on day 1|PKS||ratio||Standard Deviation|Mean
644029|NCT02223260|Primary|Central Measurement: The Mean ECT Ratio at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate.|"Central measurement: The mean Ecarin Clotting Time (ECT) ratio at 2 h and 12h (+/-2h) post administration of dabigatran etexilate. Standard deviation is actually the Coefficient of Variation.
ECT ratio= ECT(Post dose)/ECT(baseline), The mean of ECT ratio is presented."|baseline (0.5 h before intake of study medication), 2 h, and 12 h after dosing on day 1|PKS||Ratio||Standard Deviation|Mean
644030|NCT02223260|Primary|Central Measurement: The Mean aPTT Ratio at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate.|"Central measurement: The mean aPTT (activated partial thromboplastin time) ratio at 2 h and 12 h (±2 h) post administration of dabigatran etexilate. Standard deviation is actually the Coefficient of Variation.
aPTT ratio= aPTT (post dose)/aPTT (baseline). The mean of aPTT ratio is presented."|baseline (0.5 h before intake of study medication), 2 h, and 12 h after dosing on day 1|PKS||ratio||Standard Deviation|Mean
644031|NCT02223260|Primary|Central Measurement: The Mean of Diluted Thrombin Time (dTT) Coagulation Time at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate.|Central measurement: The mean of dTT (AntiFactor IIa activity) coagulation time at 2 h and 12h (+/-2h) post administration of dabigatran etexilate. Standard deviation is actually the Coefficient of Variation.|2 h, and 12 h after dosing on day 1|PKS||second||Standard Deviation|Mean
644032|NCT02223260|Primary|Central Measurement: The Mean of ECT Coagulation Time at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate.|Central measurement: The mean of Ecarin Clotting Time (ECT) coagulation time at 2 h and 12h (+/-2h) post administration of dabigatran etexilate. Standard deviation is actually the Coefficient of Variation.|2 h, and 12 h after dosing on day 1|PKS||second||Standard Deviation|Mean
644033|NCT02223260|Primary|Central Measurement: The Mean aPTT Coagulation Time at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate.|Central measurement: The mean activated partial thromboplastin time (aPTT) coagulation time at 2 h and 12 h (±2 h) post administration of dabigatran etexilate. Standard deviation is actually the Coefficient of Variation.|2 h, and 12 h after dosing on day 1|PKS||second||Standard Deviation|Mean
644332|NCT02213250|Secondary|Number of Participants With Vital Signs Post-Dose Data Met Criteria of Potential Clinical Concern (Without Regard to Baseline Abnormality)||Baseline up to 96 hours post-dose (Day 5 or early termination)|The safety analysis population included All participants who received at least 1 dose of BeneFIX.||Participants|||Number
644034|NCT02223260|Primary|Plasma Concentrations of Total Dabigatran, 2h and 12 h (+/-2h) Post Administration of Dabigatran Etexilate|Plasma concentrations of total dabigatran, 2h and 12 h (+/-2h) post administration of dabigatran etexilate.|2 hours (h) and 12h after drug administration on day 1|Pharmacokinetic set (PKS): This patient set included all treated patients who provided at least 1 PK/PD observation and had no important Protocol violations (PVs) with respect to statistical analysis of Pharmacokinetic (PK) or Pharmacodynamic (PD ) endpoints.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
644035|NCT02223065|Primary|Dapagliflozin AUC From Time 0 Extrapolated to Infinite Time (AUC[0-inf])|5-mg saxagliptin/10-mg dapagliflozin as a Fixed-dose Combination (FDC) and as Individual Tablets together in the fasted state|Day 1-3 (Period 1) and Day 8-10 (Period 2)|Evaluable PK Population||ng.h/mL||90% Confidence Interval|Geometric Mean
644036|NCT02223065|Primary|Saxagliptin AUC From Time 0 Extrapolated to Infinite Time (AUC[0-inf])|5-mg saxagliptin/10-mg dapagliflozin as a Fixed-dose Combination (FDC) and as Individual Tablets together in the fasted state|Day 1-3 (Period 1) and Day 8-10 (Period 2)|Evaluable PK Population||ng.h/mL||90% Confidence Interval|Geometric Mean
644037|NCT02223065|Primary|Dapagliflozin AUC From Time 0 to Time of the Last Quantifiable Concentration (AUC[0-T])|5-mg saxagliptin/10-mg dapagliflozin as a Fixed-dose Combination (FDC) and as Individual Tablets together in the fasted state|Day 1-3 (Period 1) and Day 8-10 (Period 2)|Evaluable PK Population||ng.h/mL||90% Confidence Interval|Geometric Mean
644038|NCT02223065|Primary|Saxagliptin AUC From Time 0 to Time of the Last Quantifiable Concentration (AUC[0-T])|5-mg saxagliptin/10-mg dapagliflozin as a Fixed-dose Combination (FDC) and as Individual Tablets together in the fasted state|Day 1-3 (Period 1) and Day 8-10 (Period 2)|Evaluable PK Population||ng.h/mL||90% Confidence Interval|Geometric Mean
644039|NCT02223065|Primary|Dapagliflozin Maximum Observed Concentrations (Cmax)|5-mg saxagliptin/10-mg dapagliflozin as a Fixed-dose Combination (FDC) and as Individual Tablets together in the fasted state|Day 1 to 3 (Period 1) and Day 8 to 10 (Period 2)|Evaluable PK Population||ng/mL||90% Confidence Interval|Geometric Mean
644040|NCT02223065|Primary|Saxagliptin Maximum Observed Concentrations (Cmax)|5-mg saxagliptin/10-mg dapagliflozin as a Fixed-dose Combination (FDC) and as Individual Tablets together in the fasted state|Day 1-3 (Period 1) and Day 8-10 (Period 2)|Evaluable PK Population||ng/mL||90% Confidence Interval|Geometric Mean
644041|NCT02222870|Secondary|Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine|Geometric titer ratios of influenza antibodies were assessed using the hemagglutination inhibition (HAI) assay.|Day 28 post-final vaccination|Geometric mean titer ratios were assessed in the Per-Protocol Analysis Set.||Titer ratio||95% Confidence Interval|Geometric Mean
644042|NCT02222870|Secondary|Percentage of Participants With Seroconversion Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine|Influenza antibodies were assessed using the hemagglutination inhibition (HAI) assay. Seroconversion is defined as either a pre-vaccination HAI titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and a ≥ 4-fold increase in post-vaccination titer.|Day 28 post-final vaccination|Seroconversion was assessed in the Per-Protocol Analysis Set.||Percentage of participants|||Number
644043|NCT02222870|Secondary|Number of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine|Influenza antibodies were assessed using the hemagglutination inhibition (HAI) assay. Seroprotection was defined as a titer ≥ 40 (l/dil) at pre-vaccination and at 28 days after the final vaccination.|Day 0 (pre-vaccination) and Day 28 post-final vaccination|Seroprotection was assessed in the Per-Protocol Analysis Set.||Percentage of participants|||Number
644044|NCT02222870|Secondary|Geometric Mean Titers (GMTs) of Influenza Antibodies Before and Post Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine|Geometric titers of influenza antibodies were assessed using the hemagglutination inhibition (HAI) assay.|Day 0 (pre-vaccination) and Day 28 post-final vaccination|Geometric mean titers were assessed in the Per-Protocol Analysis Set.||Titers (1/dilutions)||95% Confidence Interval|Geometric Mean
644045|NCT02222870|Primary|Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine|"Solicited Injection-site: 6 to < 36 months - Tenderness, Erythema, and Swelling; 3 to < 9 years - Pain, Erythema, and Swelling. Solicited systemic reactions: 6 to < 36 months - Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability; 3 to < 9 years - Fever, Headache, Malaise, and Myalgia.
Grade 3: Fever, > 39.5˚C (6 to < 36 months), ≥ 39.0˚C (3 to < 9 years); Vomiting, ≥ 6 episodes/24 hours or requires parenteral hydration; Crying abnormal, > 3 hours; Drowsiness, Sleeping often/difficult to wake; Appetite lost, Refuses ≥ 3 or most meals; Irritability, Inconsolable; Headache, Malaise, and Myalgia, Significant, prevents daily activity."|Day 0 up to Day 7 post-any injection|Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set.||Percentage of participants|||Number
644046|NCT02222818|Secondary|Percentage of Effective CRT Pacing During AF (Superiority Test)|The secondary objective is to demonstrate that the percent effective CRT pacing during AF when CAFRPlus is applied is greater than when CAFR is applied (superiority test).|Up to 4 months|Randomized subjects who had paired measurements available from both CAFR period and CAFRPlus period.||percentage of effective CRT pacing||Standard Deviation|Mean
644047|NCT02222818|Primary|Percentage of Effective CRT Pacing During AF (Non-inferiority Test)|The primary objective is to demonstrate that the percent effective CRT pacing during AF when CAFRPlus is applied is not inferior to when CAFR is applied (non-inferiority test).|Up to 4 months|Randomized subjects who had paired measurements available from both CAFR period and CAFRPlus period.||percentage of effective CRT pacing||Standard Deviation|Mean
644048|NCT02222558|Primary|Percentage of Responders|Percentage of subjects with response to treatment within each period. Response to treatment was considered when Testosterone Cavg was within the physiological range of Testosterone concentration, i.e. 300 - 1050 ng/dL.|Cavg from samples at Period 1: post dose hrs 0,1,2,3,4,5,6,8,12,16,24; Period 2: hrs 0,2,3,4,5,6,8,12,14,15,16,17,18,20,24; Period 3 BID: hrs 0,2,3,4,5,6,8,12,14,15,16,17,18,20,24; Period 3 TID: hrs 0,2,3,4,5,6,8,10,11,12,13,14,16,18,19,20,21,22,24|Subjects who received TSX-002 and provided PK concentrations for the protocol required 24 hour collection periods.||percentage of subjects|||Number
644049|NCT02222493|Primary|Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 14 in the Intent-to-Treat (ITT) Population|ACR20 response: greater than or equal to (≥) 20 percent (%) improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Week 0, Week 2, Week 4, Week 6, Week 12, and Week 14|The ITT Population was defined as all participants who were randomized to study treatment. The primary analyses for ACR20 at Week 14 were performed with the missing data imputed using a non-responder imputation method.||participants|||Number
644050|NCT02222246|Secondary|Incidence of the Need for Assistive Ventilation|Intubation or other assistive ventilation techniques - including bag, valve, or mask was performed during the ED stay; this was determined at discharge.|Following the initiation of opioid therapy until discharge from the ED, up to 6 hours|Each Emergency Department study visit was the unit of analysis for the statistical methods addressing the primary outcome.||Emergency Department Visits|Emergency Department Visits||Count of Units
644051|NCT02222246|Secondary|Incidence of the Administration of Naloxone During Emergency Department Visit|Naloxone administered during the Emergency Department stay; this was determined at discharge.|Following the initiation of opioid therapy until discharge from the ED, up to 6 hours|Each Emergency Department study visit was the unit of analysis for the statistical methods addressing the primary outcome.||Emergency Department Visits|Emergency Department Visits||Count of Units
644052|NCT02222246|Secondary|Incidence of the Need for Supplemental Oxygen During Emergency Department Visit|Need for supplemental oxygen during the Emergency Department stay; this was determined at discharge.|Following the initiation of opioid therapy until discharge from the ED, up to 6 hours|Each Emergency Department study visit was the unit of analysis for the statistical methods addressing the primary outcome.||Emergency Department Visits|Emergency Department Visits||Count of Units
644053|NCT02222246|Secondary|Incidence of Sedation During Emergency Department Visit|"Severe-to moderate sedation at any point from placement until discharge, based on sedation data collected every 30 minutes during that time period. Thus, a sedation variable was derived in which 0=no and 1=yes that moderate-severe sedation was reported by the patient at least once during the placement to discharge time interval. Sedations scoring was as follows: None was defined as awake and alert, Mild sedation was defined as responds to voice, Moderate sedation was defined as responds to touch, with or without voice and Severe sedation was defined as somnolent, difficult to arouse."|From placement in ED treatment room to discharge from the ED, up to 6 hours|Each Emergency Department study visit was the unit of analysis for the statistical methods addressing the primary outcome.||Emergency Department Visits|Emergency Department Visits||Count of Units
644054|NCT02222246|Secondary|Incidence of Respiratory Distress (YES) During Emergency Department Visit|Respiratory distress at any point from placement until discharge, based on data collected every 30 minutes during that time period. Thus, a respiratory distress variable was derived in which 0=no and 1=yes that respiratory distress was reported by the patient at least once during the placement to discharge time interval.|From placement in ED treatment room to discharge from the ED, up to 6 hours|Each Emergency Department study visit was the unit of analysis for the statistical methods addressing the primary outcome.||Emergency Department Visits|Emergency Department Visits||Count of Units
644055|NCT02222246|Secondary|Incidence of Oxygen Desaturation (< 95%) (YES) During Emergency Department Visit|Saturation of peripheral capillary oxygen < 95% (SPO2 < 95%) at any point from placement until discharge, based on SPO2 data collected every 30 minutes during that time period. Thus, a SPO2 variable was derived in which 0=no and 1=yes that SPO2 < 95% was reported by the patient at least once during the placement to discharge time interval.|From placement in ED treatment room to discharge from the ED, up to 6 hours|Each Emergency Department study visit was the unit of analysis for the statistical methods addressing the primary outcome.||Emergency Department Visits|Emergency Department Visits||Count of Units
644056|NCT02222246|Secondary|Incidence of a Decrease in Diastolic Blood Pressure Greater Than or Equal to 20% of Baseline During Emergency Department Visit|Decrease in diastolic blood pressure at any point from placement until discharge, based on blood pressure data collected every 30 minutes during that time period. A diastolic variable was derived in which 0=no and 1=yes that a > 20% decrease of baseline diastolic blood pressure was reported by the patient at least once during the placement to discharge time interval.|From placement in ED treatment room to discharge from the ED, up to 6 hours|Each Emergency Department study visit was the unit of analysis for the statistical methods addressing the primary outcome.||Emergency Department Visits|Emergency Department Visits||Count of Units
644057|NCT02222246|Secondary|Incidence of a Decrease in Systolic Blood Pressure Greater Than or Equal to 20% of Baseline During Emergency Department Visit|Decrease in systolic blood pressure at any point from placement until discharge, based on blood pressure data collected every 30 minutes during that time period. A systolic variable was derived in which 0=no and 1=yes that a >= 20% decrease of baseline systolic blood pressure was reported by the patient at least once during the placement to discharge time interval.|From placement in ED treatment room to discharge from the ED, up to 6 hours|Each Emergency Department study visit was the unit of analysis for the statistical methods.||Emergency Department Visits|Emergency Department Visits||Count of Units
644058|NCT02222246|Secondary|Incidence of Vomiting During Emergency Department Visits|Vomiting at any point from placement until discharge, based on vomiting data collected every 30 minutes during that time period. Thus, a vomiting variable was derived in which 0=no and 1=yes that vomiting was reported by the patient at least once during the placement to discharge time interval.|From placement in ED treatment room to discharge from the ED, up to 6 hours|Each Emergency Department study visit was the unit of analysis for the statistical methods.||Emergency Department Visits|Emergency Department Visits||Count of Units
644059|NCT02222246|Secondary|Incidence of Nausea During Emergency Department Visits|Nausea at any point from placement until discharge, based on nausea data collected every 30 minutes during that time period. Thus, a nausea variable was derived in which 0=no and 1=yes that nausea was reported by the patient at least once during the placement to discharge time interval.|From placement in Emergency Department (ED) treatment room to discharge from the ED, up to 6 hours|Each Emergency Department study visit was the unit of analysis for the statistical methods.||Emergency Department Visits|Emergency Department Visits||Count of Units
644060|NCT02222246|Secondary|Change in Pain Visual Analogue Scale (VAS) Scores Over Time|"Pain severity was assessed at arrival and every 30 minutes until discharge from the ED using a 100 mm visual analogue scale (VAS). The VAS range is 0 to 100 with 0 indicating “no pain” and 100 indicating “pain as bad as it could be” or “worst imaginable pain”. Discharge was defined by which one of the following occurred first: (a) decision to admit to hospital; (b) patient physically leaves the ED to home; or (c) after six hours of observation in the ED.
A hierarchical random coefficients regression model for repeated measurements (type of mixed hierarchical mixed-effect model) was conducted on the pain scores collected at six time points (arrival, post-placement 30-min, 60-min, 90-min,120-min, discharge) to evaluate the trajectory of change in pain. Discharge occurred at 120 minutes or later during each visit, with the exception of one discharge at 54 minutes."|Every 30 minutes from arrival in ED to discharge from the ED, up to 6 hours|The entire observation period was not evaluated because the patient-specific protocol has a shorter time to discharge, and, there was data missing at random after 120 minutes. To avoid a biased result, the mixed model was conducted on the data collected every 30 minutes during initial 120 minutes (2 hours) and at discharge.||Units on a 100 mm VAS|Emergency Department Visits|Standard Deviation|Mean
644061|NCT02222246|Primary|Difference in Pain Score as Measured by a Visual Analogue Scale (VAS)|Each ED study visit was the unit of analysis for the statistical methods addressing the primary outcome. The primary outcome was change in pain score from arrival to discharge. Pain severity was assessed at arrival and discharge from ED using a 100 mm visual analogue scale (VAS). The VAS range is 0 to 100 with 0 indicating “no pain” and 100 indicating “pain as bad as it could be” or “worst imaginable pain”.Discharge was defined by which one of the following occurred first: (a) decision to admit to hospital; (b) patient physically leaves the ED to home; or (c) after six hours of observation in the ED. Thus, the difference in pain scores were calculated as the arrival minus discharge VAS scores, with higher positive pain difference or change scores indicating greater pain reduction.|Arrival in ED to discharge from the ED, up to 6 hours|Each Emergency Department study visit was the unit of analysis for the statistical methods addressing the primary outcome.||Units on a 100 mm VAS|Emergency Department Visits|Standard Deviation|Mean
644062|NCT02222207|Secondary|Percentage of Participants With a Loss in BCVA of >= 10 Letters From Baseline to Study Week 12 for Study Part A|Participants were assessed at each clinic visit for BCVA using the early treatment diabetic retinopathy study chart. For participants that dropped out or received rescue treatment the last observation before drop-out or administration of rescue treatment was carried forward.|Baseline, Week 12|Full Analysis Set (FAS): included subjects who received at least one dose of study medication.||percentage of participants|||Number
644063|NCT02222207|Secondary|Percentage of Participants With Individual Changes in BCVA of Greater Than Equal to (>=) 0 Letters of Vision From Study Week 4 to Week 12 for Study Part A|Participants were assessed at each clinic visit for BCVA using the early treatment diabetic retinopathy study chart. For participants that dropped out or received rescue treatment the last observation before drop-out or administration of rescue treatment was carried forward.|Week 4, Week 12|Full Analysis Set (FAS): included subjects who received at least one dose of study medication.||percentage of participants|||Number
644064|NCT02222207|Primary|Change From Baseline in BCVA as Measured by ETDRS Letter Score at Study Week 12 for Study Part A|Participants were assessed at each clinic visit for best corrected visual acuity using the early treatment diabetic retinopathy study chart. Visual function of the study eye and the fellow eye was assessed using the ETDRS protocol. ETDRS testing score was recorded in the appropriate eCRF page at each study visit. For participants that dropped out or received rescue treatment the last observation before drop-out or administration of rescue treatment was carried forward. A higher score represents better functioning.|Baseline, Week 12|Full Analysis Set (FAS): included subjects who received at least one dose of study medication.||Score on scale||Standard Deviation|Mean
644065|NCT02222207|Primary|Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Study Week 4 for Study Part A|Participants will be assessed at each clinic visit for best corrected visual acuity using the early treatment diabetic retinopathy study chart. Visual function of the study eye and the fellow eye was assessed using the ETDRS. The participant’s ETDRS testing score was recorded in the appropriate eCRF page at each study visit. For participants that dropped out or received rescue treatment the last observation before drop-out or administration of rescue treatment was carried forward. A higher score represents better functioning.|Baseline, Week 4|Full Analysis Set (FAS): included participants who received at least one dose of study medication.||Score on scale||Standard Deviation|Mean
644066|NCT02222181|Secondary|Diastolic Blood Pressure|Diastolic pressure <90 mmHg|weekly|||mmHg||Standard Deviation|Mean
644067|NCT02222181|Secondary|Glycemia|Normal levels: 70-99mg/dL; diabetic: >121mg/dL.|two months|||mg/dL||Standard Deviation|Mean
644068|NCT02222181|Secondary|Triglycerides|Normal level: 150mg/dL|three months|||mg/dL||Standard Deviation|Mean
644069|NCT02222181|Secondary|Total Cholesterol|Total Cholesterol <200 mg/dL|Total Cholesterol|||mg/dL||Standard Deviation|Mean
644070|NCT02222181|Secondary|Systolic Blood Pressure|Systolic pressure <140 mmHg|weekly|||mmHg||Standard Deviation|Mean
644071|NCT02222181|Primary|Clinical Dementia Rating (CDR)|CDR: scale 1-3 (0-0.5: normal aging; 1- initial stage; 2- middle stage; 3- final stage)|six months|||score||Standard Deviation|Mean
644072|NCT02222181|Primary|Mini-mental State Examination (MMEE)|MMEE : scale 0-30 ( ≥25 - normal aging; 21-24 - initial stage; 20-10 - middle stage; ≤9 - final stage)|six months|||score||Standard Deviation|Mean
644073|NCT02222129|Secondary|Time to First Opioid Use.|Time to first opioid use.|All data was recorded during the patient's hospital stay, typically less than 5 days. All data was tabulated from the electronic medical record, typically within 30 days of discharge from hospital.||||||
644074|NCT02222129|Secondary|Length of Hospital Stay.|Length of hospital stay.|All data was recorded during the patient's hospital stay, typically less than 5 days. All data was tabulated from the electronic medical record, typically within 30 days of discharge from hospital.||||||
644075|NCT02222129|Secondary|Visual Analog Pain Scores.|Visual analog pain scores.|All data was recorded during the patient's hospital stay, typically less than 5 days. All data was tabulated from the electronic medical record, typically within 30 days of discharge from hospital.||||||
646152|NCT02153489|Other Pre-specified|Change From Baseline in Proportion of Sleep Stage REM as a Percentage of Total Sleep Time||Week 3 of treatment|||Percentage of total sleep time||Standard Error|Least Squares Mean
644076|NCT02222129|Primary|Total Opioid Consumption Measured in Intravenous Morphine Equivalents During the Postoperative Hospital Stay|Total opioid consumption measured in intravenous morphine equivalents during the postoperative hospital stay|All data was recorded during the patient's hospital stay, typically less than 5 days. All data was tabulated from the electronic medical record, typically within 30 days of discharge from hospital.|||mg (morphine equivalents)||Inter-Quartile Range|Median
644077|NCT02221947|Other Pre-specified|Pharmacokinetic Parameters (Cmax, Tmax, AUClast, AUCinf, λz, T1/2, CL, Vz) of Bryostatin.|Preliminary evaluation of pharmacokinetics, pharmacodynamics and to correlate the changes in protein kinase C (PKC) with plasma levels of bryostatin and with improvement in cognitive function in patients with AD. PBMC PKC activity at baseline (within 30 minutes prior to study drug infusion), during the infusion (30 and 60 min post the start of study drug infusion), and at 80 min, 2, 3, 6, 24, 48, 72 hrs and 2 weeks post start of study drug infusion. Blood will be drawn at baseline (within 30 minutes prior to study drug infusion), during the infusion (15, 30, and 60 min post start of study drug infusion), and at 80 min, 2, 3, 6, 12, 24, 36, 48, 72 hrs and 2 weeks post start of study drug infusion to assess pharmacokinetic parameters (Cmax, Tmax, AUClast, AUCinf, λz, T1/2, CL, Vz) of bryostatin.|Within 2 weeks of study drug dosing||||||
644078|NCT02221947|Secondary|Preliminary Efficacy of a Single Dose of Bryostatin in the Treatment of Patients With AD|MMSE-2 (Mini-Mental® State Examination, 2nd Edition) at 3 and 72 hours, and 2 weeks post start of study drug infusion|within 2 weeks of study drug dosing||||||
644079|NCT02221947|Secondary|Preliminary Efficacy of a Single Dose of Bryostatin in the Treatment of Patients With AD|CDR, Clinical Dementia Rating Sum of Boxes (CDR-SB) and individual items at 2 weeks post start of study drug infusion|within 2 weeks of study drug dosing||||||
644080|NCT02221947|Secondary|Preliminary Efficacy of a Single Dose of Bryostatin in the Treatment of Patients With AD|Digit Symbol Coding at 3, 24 and 48 hours and 2 weeks post start of study drug infusion|within 2 weeks of study drug dosing||||||
644081|NCT02221947|Secondary|Preliminary Efficacy of a Single Dose of Bryostatin in the Treatment of Patients With AD|HVLT-R (Hopkins Verbal Learning Test–Revised™ (HVLT-R™) delayed free recall, HVLT-R delayed cued recall, HVLT-R delayed recognition recall, RBANS figure recall at 48 hour post start of study drug infusion. HVLT-R delayed free recall, HVLT-R delayed cued recall, HVLT-R delayed recognition recall, RBANS figure recall at 24 hours and 2 weeks post start of study drug infusion HVLT-R delayed free recall, HVLT-R delayed cued recall, HVLT-R delayed recognition recall of stimuli presented 48 hours post study drug infusion, as assessed 72 hours post start of study drug infusion.|Within 2 weeks of study drug dosing||||||
644082|NCT02221947|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Evaluate the safety and tolerability of bryostatin 1 (hereinafter referred to as bryostatin) in patients with Alzheimer's Disease (AD) following a single intravenous (IV) dose.|Within 2 weeks of study drug dosing|||event|||Number
644083|NCT02221648|Secondary|Number of Subjects Showing Improvement on Quality of Life Scale for Pain|The Quality of Life Scale: A Measure of Function for People With Pain was developed by the American Chronic Pain Association (ACPA). The patient is asked to rank their quality of life on a scale of zero (non-functioning) to 10 (normal quality of life). Improvement was defined as 2 or more grades of improvement on the scale.|6 weeks|||participants|||Number
644084|NCT02221648|Secondary|Number of Patients With Improved Pain Using the Patient Global Impression of Change (PGIC)|"The PGIC is a 7 point scale that requires the clinician to assess how much the patient's pain has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as:
No change (or condition has gotten worse) (1) Almost the same, hardly any change at all (2) A little better, but no noticeable change (3) Somewhat better, but the change has not made any real difference (4) Moderately better, and a slight but noticeable change (5) Better and a definite improvement that has made a real and worthwhile difference (6) A great deal better and a considerable improvement that has made all the difference (7)
This outcome is number of patients who chose a 6 or above on the PGIC 6 weeks after treatment"|6 weeks|||participants|||Number
644085|NCT02221648|Primary|Proportion of Participants With Mild or no Pain on Visual Analog Scale (VAS)|The primary outcome measure in this protocol is the proportion of subjects that have VAS <4 (patients with no or mild pain) at week 6. The pain VAS is a continuous scale comprised of a line 10 centimeters in length, anchored by 2 verbal descriptors, one for each symptom extreme. For pain intensity, the scale is anchored by “no pain” (score of 0) and “worst imaginable pain” (score of 10).|6 weeks|||participants|||Number
644086|NCT02221557|Primary|Percentage Change in Radiographic Measurement of Alveolar Ridge Height|Radiographic measurement was taken at most-middle portion of the grafted site, perpendicular to the line drawn from reference point (e.g. adjacent tooth/teeth Cement-Enamel Junction (CEJ) or margin of the restoration).|Change from baseline to 6 months|||percentage of change||Standard Deviation|Mean
644087|NCT02220998|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as
On-treatment virologic failure:
Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)
Virologic relapse:
Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 24|Full Analysis Set||percentage of participants|||Number
644088|NCT02220998|Secondary|Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, and 12||Baseline; Weeks 1, 2, 4, 6, 8, 10, and 12|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
644089|NCT02220998|Secondary|Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12||Weeks 1, 2, 4, 6, 8, 10, and 12|||percentage of participants||95% Confidence Interval|Number
644090|NCT02220998|Secondary|Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set||percentage of participants||95% Confidence Interval|Number
644091|NCT02220998|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 12 weeks|Safety Analysis Set||percentage of participants|||Number
644092|NCT02220998|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants randomized or enrolled into the study and received at least 1 dose of study drug.||percentage of participants||95% Confidence Interval|Number
644093|NCT02220920|Secondary|"Percentage of Participants With Adverse Events and Hypoglycemia and Blood Glucose Decreased"||Week 16|"Safety analysis set. Safety Population reflects the as treated population, and one Canagliflozin (TA-7284) + Insulin participant actually received Placebo + Insulin."||percentage of participants|||Number
644094|NCT02220920|Secondary|Change in Blood Pressure||baseline and Week 16|Full analysis set, last observation carried forward||mmHg||Standard Error|Least Squares Mean
644095|NCT02220920|Secondary|Percent Change in Body Weight||baseline and Week 16|"Full analysis set, last observation carried forward. There was a lack of measurement of body weight at the end of treatment visit(Week 4) in one participant who was randomized to Canagliflozin(TA-7284) + Insulin group."||percent change||Standard Error|Least Squares Mean
644096|NCT02220920|Secondary|Change in Fasting Plasma Glucose||baseline and Week 16|"Full analysis set, last observation carried forward. There was a lack of measurement of fasting plasma glucose at the end of treatment visit(Week 4) in one participant who was randomized to Canagliflozin(TA-7284) + Insulin group."||mg/dL||Standard Error|Least Squares Mean
644097|NCT02220920|Primary|Change in HbA1c From Baseline||baseline and Week 16|Full analysis set, last observation carried forward||Percent||Standard Error|Least Squares Mean
644098|NCT02220764|Other Pre-specified|Number of of Fixed Dental Prostheses (FDPs) With Rough Surface|Measurement of the restorations with rough surface 6,12,18,24,30 and 36 months after placement of the restorations.|3 years|||FDPs with rough surface|||Number
644099|NCT02220764|Secondary|Number of Fixed Dental Prostheses (FDPs) With Chip/s|Measurement of the amount of fractures of the veneering material 6,12,18,24,30 and 36 months after placement of the restorations. The percentage of chips for the implant- and tooth- supported restorations will be reported.|3 years|||FDPs with chip/s|||Number
644100|NCT02220764|Primary|Number of Fixed Dental Prostheses (FDPs) With Failure|"Failure was recorded if there was a need to remove the Fixed Dental Prosthesis over the observation period."|3 years|||FDPs with failure|||Number
644101|NCT02220205|Secondary|Percent Change in Comfort Placing IUDs From Pre- to Post-insertion|Participants were given questionnaires at the initial study visit and at a three-month follow-up visit that assessed their comfort with IUD insertion using a modified Likert scale.|Baseline to three months|||Percent change in comfort|||Number
644102|NCT02220205|Primary|Insertion Score Before and Immediately After Initial Practice (Same Day), and 3 Months After Initial Practice|"Participants were filmed performing 3 IUD insertions each, for three IUDs available in the US. They then practiced on an assigned simulator for 30 minutes, and were re-recorded immediately afterwards. Three months after initial practice, they returned and performed the insertions again.
Sets of insertions were scored using a checklist. Participants earned up to 86 points for performing various elements of IUC insertion correctly: sounding the uterus (14 points), and loading as well as inserting the copper device (24 points), levonorgestrel 52mg device (26 points), and levonorgestrel 13.5mg device (22 points). Higher scores were better."|Before and immediately after initial practice on assigned simulator (same day), and three months after initial practice|||Percent of tasks performed correctly||Inter-Quartile Range|Median
644103|NCT02219997|Secondary|Change in Braking Reaction Time From No-glare to Glare (ACRYSOF® IQ IOL + Placebo Filter; Clear IOL + BLF)|Braking reaction time (time to brake, in seconds) was assessed using a driving simulator in no-glare and glare conditions. The subject was presented with a driving scenario during which an obstruction (car pulling over from either side of the road in a random fashion) was presented. Subjects braked in an attempt to avoid colliding with the obstruction, and the braking reaction time was recorded. The experiment was repeated with a glare source present. Both assessments (no-glare and glare) occurred on the same day. Change in braking reaction time was calculated as glare minus no-glare.|Visit 2, Up to Day 30|This analysis population is a subset of all randomized subjects with no major protocol violations and had non-missing values at the specific time point for each arm, respectively.||seconds||Standard Deviation|Mean
644104|NCT02219997|Secondary|Change in Braking Reaction Time From No-glare to Glare (Clear IOLs)|Braking reaction time (time to brake, in seconds) was assessed using a driving simulator in no-glare and glare conditions. The subject was presented with a driving scenario during which an obstruction (car pulling over from either side of the road in a random fashion) was presented. Subjects braked in an attempt to avoid colliding with the obstruction, and the braking reaction time was recorded. The experiment was repeated with a glare source present. Both assessments (no-glare and glare) occurred on the same day. Change in braking reaction time was calculated as glare minus no-glare. This outcome measure was pre-specified for Clear IOL only.|Visit 2, Up to Day 30|This analysis population is a subset of all randomized subjects with no major protocol violations and had non-missing values at the specific time point for each arm, respectively.||seconds||Standard Deviation|Mean
644105|NCT02219997|Primary|Change in Braking Reaction Time From No-glare to Glare|Braking reaction time (time to brake, in seconds) was assessed using a driving simulator in no-glare and glare conditions. The subject was presented with a driving scenario during which an obstruction (car pulling over from either side of the road in a random fashion) was presented. Subjects braked in an attempt to avoid colliding with the obstruction, and the braking reaction time was recorded. The experiment was repeated with a glare source present. Both assessments (no-glare and glare) occurred on the same day. Change in braking reaction time was calculated as glare minus no-glare.|Visit 2, up to Day 30|This analysis population includes subjects who were reaction tested with no major protocol violations (per protocol).||seconds||Standard Deviation|Mean
644113|NCT02219685|Secondary|Change From Baseline in Health-Related Quality of Life at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by WPAI: Hepatitis C - Activity Impairment|Activity impairment was measured using the WPAI: Hepatitis C questionnaire completed by participants during study visits throughout the study. This questionnaire measured the effect of hepatitis C on the ability to work and perform regular activities. Overall activity impairment is expressed as a percentage and ranges from 0% (no effect) to 100% (completely prevented from performing regular activities).|Baseline; Posttreatment Weeks 4 and 24|Participants in the Full Analysis Set with available data were analyzed.||units on a scale||Standard Deviation|Mean
644106|NCT02219932|Secondary|Change From Baseline in ABILHAND Score Over 24 Weeks|"The ABILHAND Questionnaire measures a participant’s perceived difficulty in performing everyday manual activities in the last 3 months. The participant completes a 56-item questionnaire by estimating their own difficulty or ease in performing each of 56 activities. Items are summed to generate a total score and transformed to a scale with a range of 0 (poor manual ability) to 100 (good manual ability); a positive change indicates an improvement in manual ability.
Data are based on an MMRM model using a common variance AR(1) variance-covariance matrix structure. Treatment, visit and treatment by visit interaction were included in the model as explanatory variables, adjusting for screening EDSS, baseline ABILHAND and prior aminopyridine as covariates. Missing data are handled using multiple imputation and baseline is defined as the Day 1 assessment."|Baseline to Week 24|Intent-to-treat population: participants who received at least 1 dose of study drug and had at least 1 postbaseline efficacy assessment and available data.||units on a scale||Standard Error|Least Squares Mean
644107|NCT02219932|Secondary|Change From Baseline in Berg Balance Scale (BBS) Over 24 Weeks|"The BBS is a widely used assessment tool to identify balance impairment. Functional activities such as reaching, bending, transferring, and standing are evaluated on the test to evaluate balance. Participants are asked to complete 14 tasks that are rated from 0 (cannot perform) to 4 (normal performance) for a total of 56 points. BBS scores range from 0 (poor balance) to 56 (good balance); a positive change indicates improvement.
Data are based on an MMRM model using a common variance AR(1) variance-covariance matrix structure. Treatment, visit and treatment by visit interaction were included in the model as explanatory variables, adjusting for screening EDSS, baseline BBS and prior aminopyridine as covariates. Missing data are handled using multiple imputation and baseline is defined as the mean over screening and Day 1."|Baseline to Week 24|Intent-to-treat population: participants who received at least 1 dose of study drug and had at least 1 postbaseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
644108|NCT02219932|Secondary|Change From Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) Physical Score Over 24 Weeks|"The 29-item MSIS-29 is a participant-reported outcome measure to assess the impact of MS on day-to-day life during the past 2 weeks from a participant’s perspective; it measures 20 physical items and 9 psychological items. The physical score is generated by summing individual items and then transforming to a scale with a range of 0 (no impact of MS) to 100 (extreme impact of MS); a negative change indicates an improvement in function.
Data are based on a mixed model for repeated measures (MMRM) model using a common variance AR(1) variance-covariance matrix structure. Treatment, visit and treatment by visit interaction were included in the model as explanatory variables, adjusting for screening EDSS, baseline MSIS-29 physical score and prior aminopyridine as covariates. Missing data are handled using multiple imputation and baseline is defined as the mean over screening and Day 1."|Baseline to Week 24|Intent-to-treat population: participants who received at least 1 dose of study drug and had at least 1 postbaseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
644109|NCT02219932|Secondary|Proportion of Participants Achieving a Mean Improvement From Baseline of ≥ 15% in Timed Up and Go (TUG) Speed Over 24 Weeks|"TUG is a timed walking test designed to measure gait performance and balance. It measures in seconds the time taken by an individual to stand up from a standard arm chair (approximate seat height of 46 cm [18in], arm height 65 cm [25.6 in]), walk a distance of 3 meters (118 inches, approximately 10 feet), turn, walk back to the chair, and sit down.
A responder is defined as a participant with a mean improvement of at least 15% in TUG speed over 24 weeks compared to baseline. Baseline is defined as the mean at Screening and Day 1 visits. Estimated proportion obtained from binomial proportions. There are 2 TUG tests given, and the average across the 2 tests is used to calculate average speed. Healthy participants below the age of 79 are expected to complete this task in 7-10 seconds (American College of Rheumatology). Missing data are handled using multiple imputation and baseline is defined as the mean over Screening and Day 1."|Baseline to Week 24|Intent-to-treat population: participants who received at least 1 dose of study drug and had at least 1 postbaseline efficacy assessment.||proportion of participants|||Number
644110|NCT02219932|Primary|Proportion of Participants Achieving a Mean Improvement of ≥ 8 Points From Baseline on the Multiple Sclerosis Walking Scale (MSWS-12) Over 24 Weeks|"MSWS-12 is a participant self-assessment of the walking limitations due to MS during the past 2 weeks. It contains 12 items that measure the impact of MS on walking. Items are summed to generate a total score and transformed to a scale with a range of 0 to 100, where higher scores indicate greater impact on walking.
A responder is defined as a participant with a mean improvement of at least 8 points over 24 weeks compared to baseline. Baseline is defined as the mean at Screening and Day 1 visits. If a participant has a mean MSWS-12 score of < 0.5 over the double-blind period, and a baseline MSWS-12 score of < 8 points, the participant is counted as a responder. A participant who indicates they cannot walk at all on MSWS-12 during any double-blind visit, and who shows severe disability and an inability to walk on other efficacy assessments is counted as a non-responder. Estimated proportion obtained from binomial proportions."|Baseline to 24 weeks|Intent-to-treat population: participants who received at least 1 dose of study drug and had at least 1 postbaseline efficacy assessment.||proportion of participants|||Number
644111|NCT02219685|Secondary|Change From Pre-treatment Assessment in Mood Related Assessment at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by Beck Hopelessness Scale (BHS)|The BHS is a 20-item scale for measuring the extent of negative attitudes about the future (pessimism) as perceived by adolescents and adults. The BHS consists of 20 true-false statements. Each of the 20 statements is scored 1 or 0. Of the 20 true-false statements, 9 are keyed FALSE, and 11 are keyed TRUE to indicate endorsement of pessimism about the future. The item scores are summed to yield a total score that can range from 0 to 20 with higher scores indicating greater hopelessness.|Baseline; Posttreatment Weeks 4 and 24|Full Analysis Set||units on a scale||Standard Deviation|Mean
644112|NCT02219685|Secondary|Change From Pre-treatment Assessment in Mood Related Assessment at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by Beck Depression Inventory-II (BDI-II)|The BDI-II is a 21-item self-report instrument for measuring the severity of depression. Each item is rated on a 4-point scale ranging from 0 to 3. The item scores are summed to yield a derived total score that can range from 0 to 63 with lower values indicating less depression.|Baseline; Posttreatment Weeks 4 and 24|Participants in the Full Analysis Set with available data were analyzed.||units on a scale||Standard Deviation|Mean
644114|NCT02219685|Secondary|Change From Baseline in Health-Related Quality of Life at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by Work Productivity and Activity Impairment Questionnaire, Hepatitis C (WPAI: Hepatitis C) - Overall Work Impairment|Impairment in overall work productivity was measured using the WPAI: Hepatitis C questionnaire completed by participants during study visits throughout the study. This questionnaire measured the effect of hepatitis C on the ability to work and perform regular activities. Overall work impairment is expressed as a percentage and ranges from 0% (no effect) to 100% (completely prevented from working).|Baseline; Posttreatment Weeks 4 and 24|Participants in the Full Analysis Set with available data were analyzed.||units on a scale||Standard Deviation|Mean
644115|NCT02219685|Secondary|Change From Baseline in Health-Related Quality of Life at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)|The FACIT-Fatigue score was measured using a 40-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale from 0 (Not at all) to 4 (Very much). The FACIT-F total score was calculated by taking the sum of all 40 individual scores and ranged from 0-160, with higher scores indicating better quality of life.|Baseline; Posttreatment Weeks 4 and 24|Participants in the Full Analysis Set with available data were analyzed.||units on a scale||Standard Deviation|Mean
644116|NCT02219685|Secondary|Change From Baseline in Health-Related Quality of Life at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by Chronic Liver Disease Questionnaire - HCV (CLDQ-HCV)|The CLDQ-HCV is a disease-specific questionnaire measuring health-related quality of life. CLDQ-HCV scores are calculated using participant responses to 29 questions divided into 4 domains: Activity/Energy, Emotion, Worry, and Systemic. An overall CLDQ-HCV score is calculated by taking the mean of all domain scores. Overall CLDQ-HCV scores range between 1 and 7, with higher scores representing better quality of life.|Baseline; Posttreatment Weeks 4 and 24|Participants in the Full Analysis Set with available data were analyzed.||units on a scale||Standard Deviation|Mean
644117|NCT02219685|Secondary|Change From Baseline in Health-Related Quality of Life at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by SF-36 Health Survey Scale - Mental Component Score|The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). The last 5 concepts constitute the mental component summary. The total score is an average of the individual question scores, which are scaled 0-100 with lower score representing more disability and higher scores representing less disability.|Baseline; Posttreatment (PT) Weeks 4 and 24|Participants in the Full Analysis Set with available data were analyzed.||units on a scale||Standard Deviation|Mean
644118|NCT02219685|Secondary|Change From Baseline in Health-Related Quality of Life at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by Short Form 36 (SF-36) Health Survey Scale - Physical Component Score|The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). The first 6 concepts constitute the physical component summary. The total score is an average of the individual question scores, which are scaled 0-100 with lower scores representing more disability and higher scores representing less disability.|Baseline; Posttreatment Weeks 4 and 24|Participants in the Full Analysis Set with available data were analyzed.||units on a scale||Standard Deviation|Mean
644119|NCT02219685|Secondary|Change From Baseline in Neurocognitive Function at 24 Weeks After Discontinuation of Therapy: Motor|"Neurocognitive function tests were administered by a licensed clinician. The sum of following neurocognitive test scores was used to determine the Motor score: dominant hand fine motor speed (time) (DomHtot) and non-dominant hand fine motor speed (time) (nonDOMHtot).
For this analysis, Motor score (total) ranged from 20 to 600, with lower scores indicating better fine motor speed."|Baseline; Posttreatment Week 24|"Participants in the Full Analysis Set with available data were analyzed. Data for the Open-Label Phase: LDV/SOF group are not presented because this group did not have a Posttreatment Week 24 visit after receiving placebo. These participants were enrolled into the Open-Label Phase after Posttreatment Week 4."||units on a scale||Standard Deviation|Mean
644120|NCT02219685|Secondary|Change From Baseline in Neurocognitive Function at 24 Weeks After Discontinuation of Therapy: Executive 2 Conceptual Shift and Initiation|"Neurocognitive function tests were administered by a licensed clinician. The sum of following neurocognitive test scores was used to determine the Executive 2 Conceptual Shift and Initiation score: trails B raw score (TrailBRS), age & education adjusted raw score (FASadj), color word interference score (time) (CWTrial3), and color word interference/shifting score (time) (CWTrial4).
For this analysis, Executive 2 Conceptual Shift and Initiation score (total) ranged from 1 to 570, with lower scores indicating better executive control."|Baseline; Posttreatment Week 24|"Participants in the Full Analysis Set with available data were analyzed. Data for the Open-Label Phase: LDV/SOF group are not presented because this group did not have a Posttreatment Week 24 visit after receiving placebo. These participants were enrolled into the Open-Label Phase after Posttreatment Week 4."||units on a scale||Standard Deviation|Mean
644121|NCT02219685|Secondary|Change From Baseline in Neurocognitive Function at 24 Weeks After Discontinuation of Therapy: Executive 1 Processing Speed|"Neurocognitive function tests were administered by a licensed clinician. The sum of following neurocognitive test scores was used to determine the Executive 1 Processing Speed score: symbol search total scaled score (SSSS) and trails A total raw score (TrailARS).
For this analysis, Executive 1 Processing Speed score (total) ranged from 1 to 108, with lower scores indicating better executive control."|Baseline; Posttreatment Week 24|"Participants in the Full Analysis Set with available data were analyzed. Data for the Open-Label Phase: LDV/SOF group are not presented because this group did not have a Posttreatment Week 24 visit after receiving placebo. These participants were enrolled into the Open-Label Phase after Posttreatment Week 4."||units on a scale||Standard Deviation|Mean
644133|NCT02219516|Primary|Renal Clearance Time 0 to 72 Hours Postdose (CLR 0-72)|CLR 0-72 following a single administration of RDEA3170 to subjects with various degrees of renal function|Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose|||mL/min||95% Confidence Interval|Geometric Mean
644122|NCT02219685|Secondary|Change From Baseline in Neurocognitive Function at 24 Weeks After Discontinuation of Therapy: Attention Scaled Score|"Neurocognitive function tests were administered by a licensed clinician. The sum of following neurocognitive test scores was used to determine the Attention Scaled Score: forward digit span scaled score (FSCORESS), backward digit span scaled score (BSCORESS), and symbol span total scaled score (SYMSPSS).
For this analysis, Attention Scaled Score (total) ranged from 3 to 57, with higher scores indicating better working memory capacity and control."|Baseline; Posttreatment Week 24|"Participants in the Full Analysis Set with available data were analyzed. Data for the Open-Label Phase: LDV/SOF group are not presented because this group did not have a Posttreatment Week 24 visit after receiving placebo. These participants were enrolled into the Open-Label Phase after Posttreatment Week 4."||units on a scale||Standard Deviation|Mean
644123|NCT02219685|Secondary|Change From Baseline in Neurocognitive Function at 24 Weeks After Discontinuation of Therapy: Memory T Score|"Neurocognitive function tests were administered by a licensed clinician. The sum of following neurocognitive test scores was used to determine the Memory T Score: visuospatial memory immediate total T score (BVMTTTs), visuospatial memory delayed T score (BVMTTDTS), verbal memory total T score (HVLTTTS), and verbal memory delayed T score (HVLTDTS).
For this analysis, Memory T Score (total) ranged from 80 to 320, with higher scores indicating better memory."|Baseline; Posttreatment Week 24|"Participants in the Full Analysis Set with available data were analyzed. Data for the Open-Label Phase: LDV/SOF group are not presented because this group did not have a Posttreatment Week 24 visit after receiving placebo. These participants were enrolled into the Open-Label Phase after Posttreatment Week 4."||units on a scale||Standard Deviation|Mean
644124|NCT02219685|Secondary|Percentage of Participants With Sustained Virologic Response (SVR) at 4, 12, and 24 Weeks After Discontinuation of Therapy (SVR4, SVR12, and SVR24)|SVR4, SVR12, and SVR24 were defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 4, 12, and 24 weeks after stopping study treatment with LDV/SOF, respectively.|Posttreatment Weeks 4, 12, and 24|Full Analysis Set||percentage of participants||95% Confidence Interval|Number
644125|NCT02219685|Primary|Change From Baseline in Neurocognitive Function at 4 Weeks After Discontinuation of Therapy: Motor|"Neurocognitive function tests were administered by a licensed clinician. The sum of following neurocognitive test scores was used to determine the Motor score: dominant hand fine motor speed (time) (DomHtot) and non-dominant hand fine motor speed (time) (nonDOMHtot).
For this analysis, Motor score (total) ranged from 20 to 600, with lower scores indicating better fine motor speed."|Baseline; Posttreatment Week 4|Full Analysis Set||units on a scale||Standard Deviation|Mean
644126|NCT02219685|Primary|Change From Baseline in Neurocognitive Function at 4 Weeks After Discontinuation of Therapy: Executive 2 Conceptual Shift and Initiation|"Neurocognitive function tests were administered by a licensed clinician. The sum of following neurocognitive test scores was used to determine the Executive 2 Conceptual Shift and Initiation score: trails B raw score (TrailBRS), age & education adjusted raw score (FASadj), color word interference score (time) (CWTrial3), and color word interference/shifting score (time) (CWTrial4).
For this analysis, Executive 2 Conceptual Shift and Initiation score (total) ranged from 1 to 570, with lower scores indicating better executive control."|Baseline; Posttreatment Week 4|Full Analysis Set||units on a scale||Standard Deviation|Mean
644127|NCT02219685|Primary|Change From Baseline in Neurocognitive Function at 4 Weeks After Discontinuation of Therapy: Executive 1 Processing Speed|"Neurocognitive function tests were administered by a licensed clinician. The sum of following neurocognitive test scores was used to determine the Executive 1 Processing Speed score: symbol search total scaled score (SSSS) and trails A total raw score (TrailARS).
For this analysis, Executive 1 Processing Speed score (total) ranged from 1 to 108, with lower scores indicating better executive control."|Baseline; Posttreatment Week 4|Full Analysis Set||units on a scale||Standard Deviation|Mean
644128|NCT02219685|Primary|Change From Baseline in Neurocognitive Function at 4 Weeks After Discontinuation of Therapy: Attention Scaled Score|"Neurocognitive function tests were administered by a licensed clinician. The sum of following neurocognitive test scores was used to determine the Attention Scaled Score: forward digit span scaled score (FSCORESS), backward digit span scaled score (BSCORESS), and symbol span total scaled score (SYMSPSS).
For this analysis, Attention Scaled Score (total) ranged from 3 to 57, with higher scores indicating better working memory capacity and control."|Baseline; Posttreatment Week 4|Full Analysis Set||units on a scale||Standard Deviation|Mean
644129|NCT02219685|Primary|Change From Baseline in Neurocognitive Function at 4 Weeks After Discontinuation of Therapy: Memory T Score|"Neurocognitive function tests were administered by a licensed clinician. The sum of following neurocognitive test scores was used to determine the Memory T Score: visuospatial memory immediate total T score (BVMTTTs), visuospatial memory delayed T score (BVMTTDTS), verbal memory total T score (HVLTTTS), and verbal memory delayed T score (HVLTDTS).
For this analysis, Memory T Score (total) ranged from 80 to 320, with higher scores indicating better memory."|Baseline; Posttreatment Week 4|Full Analysis Set||units on a scale||Standard Deviation|Mean
644130|NCT02219685|Primary|Change From Baseline in MRS Metabolic Ratio at 4 Weeks After Discontinuation of Therapy: Myoinositol|MRS was analyzed in the LCmodel program and measured in 3 specific areas of brain (basal ganglia, frontal cortex, and dorsolateral prefrontal cortex). The cerebral metabolic signal myoinositol was analyzed. Spectroscopy results are expressed as metabolic ratio with creatine used as the control metabolite, so there are no units of measure.|Baseline; Posttreatment Week 4|Full Analysis Set||ratio||Standard Deviation|Mean
644131|NCT02219685|Primary|Change From Baseline in MRS Metabolic Ratio at 4 Weeks After Discontinuation of Therapy: Choline|MRS was analyzed in the LCmodel program and measured in 3 specific areas of brain (basal ganglia, frontal cortex, and dorsolateral prefrontal cortex). The cerebral metabolic signal choline was analyzed. Spectroscopy results are expressed as metabolic ratio with creatine used as the control metabolite, so there are no units of measure.|Baseline; Posttreatment Week 4|Full Analysis Set||ratio||Standard Deviation|Mean
644132|NCT02219685|Primary|Change From Baseline in Magnetic Resonance Spectroscopy (MRS) Metabolic Ratio at 4 Weeks After Discontinuation of Therapy: NAA + NAAG|MRS was analyzed in the LCmodel program and measured in 3 specific areas of brain (basal ganglia, frontal cortex, and dorsolateral prefrontal cortex). The cerebral metabolic signal N-acetylaspartate (NAA) + N-acetylaspartylglutamate (NAAG) was analyzed. Spectroscopy results are expressed as metabolic ratio with creatine used as the control metabolite, so there are no units of measure.|Baseline; Posttreatment Week 4|Full Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug.||ratio||Standard Deviation|Mean
644134|NCT02219516|Primary|Total Body Clearance Corrected for Bioavailability (CL/F)|CL/F following a single administration of RDEA3170 to subjects with various degrees of renal function|Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose|||L/hr||95% Confidence Interval|Geometric Mean
644135|NCT02219516|Primary|Non-renal Clearance From Time 0 to 72 Hours Postdose (CLNR 0-72)|CLNR 0-72 following a single administration of RDEA3170 to subjects with various degrees of renal function|Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose|||L/hr||95% Confidence Interval|Geometric Mean
644136|NCT02219516|Primary|Apparent Terminal Half-life (t1/2)|t1/2 following a single administration of RDEA3170 to subjects with various degrees of renal function|Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose|||hr||95% Confidence Interval|Geometric Mean
644137|NCT02219516|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC∞)|AUC∞ following a single administration of RDEA3170 to subjects with various degrees of renal function|Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose|||ng.hr/mL||95% Confidence Interval|Geometric Mean
644138|NCT02219516|Primary|Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)|AUC last following a single administration of RDEA3170 to subjects with various degrees of renal function|Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose|||ng.hr/mL||95% Confidence Interval|Geometric Mean
644139|NCT02219516|Primary|Time of Occurrence of Maximum Observed Concentration (Tmax)|Tmax following a single administration of RDEA3170 to subjects with various degrees of renal function|Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose|||hr||Full Range|Median
644140|NCT02219516|Primary|Maximum Observed Plasma Concentration (Cmax)|Cmax following a single administration of RDEA3170 to subjects with various degrees of renal function|Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose|||ng/mL||95% Confidence Interval|Geometric Mean
644141|NCT02219516|Secondary|Pharmacodynamics (PD) Profiles of Uric Acid From Serum and Urine||Screening, Day -1 ( -24, -21, -18, -and -12 hours predose), and Day 1 (within 30 minutes prior to dosing and at 3, 6, 12, 24, 30, 36, 48, 54, 60, and 72 hours postdose)|||Maximum Percentage (%) Change||Standard Error|Mean
644142|NCT02219516|Secondary|Incidence of Treatment-Emergent Adverse Events||5 weeks|||Number of participants|||Number
644143|NCT02219503|Secondary|Percentage of Participants With Post-Treatment Relapse|Post- Treatment Relapse is defined as confirmed HCV RNA >= LLOQ between end of treatment and 12 weeks after last actual dose of active study drug [up to and including the SVR12 assessment time point] for a participant with HCV RNA < LLOQ at Final Treatment Visit who completes treatment.|Post-treatment Day 1 to Post-treatment Week 12|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).||percentage of participants||95% Confidence Interval|Number
644144|NCT02219503|Secondary|Percentage of Participants With On-Treatment Virologic Failure|On-Treatment Virologic Failure is defined as confirmed HCV RNA >= LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase from nadir (local minimum value) in HCV RNA [2 consecutive HCV RNA measurements > 1 log10 IU/mL above nadir] at any time point during treatment, or failure to suppress during treatment [all on-treatment values of HCV RNA >= LLOQ] with at least 6 weeks [defined as active study drug duration ≥ 36 days] of treatment.|Day 1 through Week 12|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).||percentage of participants||95% Confidence Interval|Number
644145|NCT02219503|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment|"Sustained Virologic Response 12 (SVR12) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (< LLOQ; < 25 IU/mL) 12 weeks after the last dose of study drug.
The primary efficacy endpoints were non-inferiority and superiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm compared with the historical threshold for sofosbuvir and peginterferon (pegIFN)/RBV for the treatment of subjects with HCV GT1b infection and cirrhosis."|Post-treatment Day 1 to Post-treatment Week 12|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).||percentage of participants||95% Confidence Interval|Number
644146|NCT02219477|Secondary|Percentage of Participants With Improvement From Baseline to Post-Treatment Week 12 in Model for End-Stage Liver Disease (MELD) Score|MELD is a scoring system for assessing the severity of chronic liver disease. Scores range from 6 to 40, with higher scores indicating more severity. Improvement was defined as a decrease of 1 or more from baseline to post-treatment Week 12.|Up to post-treatment Week 12|Intent to treat population: all participants who received at least 1 dose of study drug with values at both baseline and post-treatment Week 12.||percentage of participants|||Number
644147|NCT02219477|Secondary|Percentage of Participants With Improvement From Baseline to Post-Treatment Week 12 in Chld-Pugh Score|The The Child-Pugh score uses five clinical measures of liver disease (3 laboratory parameters and 2 clinical assessments) to measure severity of cirrhosis. Scores range from 5 to 15, with higher scores indicating more severity. Improvement was defined as a decrease of 1 or more from baseline to post-treatment Week 12.|Up to post-treatment Week 12|Intent to treat population: all participants who received at least 1 dose of study drug with values at both baseline and post-treatment Week 12.||percentage of participants|||Number
644148|NCT02219477|Secondary|Percentage of Participants With Improvement From Baseline to Post-Treatment Week 12 in FibroTest|The FibroTest score is used to assess liver fibrosis. Scores range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis. Improvement was defined as a decrease of more than 0.2 from baseline to post-treatment Week 12.|Up to post-treatment Week 12|Intent to treat population: all participants who received at least 1 dose of study drug with values at both baseline and post-treatment Week 12.||percentage of participants|||Number
644161|NCT02219256|Primary|Number of Participants Who Meet the TDC Markedly Abnormal Criteria for Safety 12-lead Electrocardiogram (ECG) Parameters at Least Once Post Dose||First dose up to Day 78|The safety analysis set included all participants who were enrolled, received 1 dose of study drug (after study drug dosing started) inclusive of those participants who did not complete all scheduled study visits.||participants|||Number
644149|NCT02219477|Secondary|Percentage of Participants With Improvement From Baseline to Post-Treatment Week 12 in Hepatic Function Tests|"Improvement was defined as:
increase of more than 0.2 g/L from baseline to post-treatment Week 12 in albumin
decrease of more than 0.3 µmol/L from baseline to post-treatment Week 12 in bilirubin
decrease of more than 5 ng/mL from baseline to post-treatment Week 12 in alpha-fetoprotein
increase of more than 15*10^9/L from baseline to post-treatment Week 12 in platelet count
decrease of more than 0.2 from baseline to post-treatment Week 12 in international normalized ratio."|Up to post-treatment Week 12|Intent to treat population: all participants who received at least 1 dose of study drug with values at both baseline and post-treatment Week 12 for the respective parameter.||percentage of participants|||Number
644150|NCT02219477|Secondary|Percentage of Participants With SVR12 Non-Response Due to Experiencing Relapse˅12|Relapse˅12 was defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of active study drug (up to and including the SVR12 window) for a participant with HCV RNA < LLOQ at final treatment visit who completes treatment and has post-treatment HCV RNA data. Completion of treatment was defined as a study drug duration ≥ 77 days for participants assigned to 12 weeks of treatment or ≥ 154 days for participants assigned to 24 weeks of treatment. SVR12 was defined as HCV RNA < LLOQ in the SVR12 window (12 weeks after the last actual dose of study drug) without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. The 95% confidence interval was calculated using the Wilson score method.|Up to 12 weeks after the last actual dose of study drug|Intent to treat population: all participants who received at least 1 dose of study drug and who had an assessment.||percentage of participants||95% Confidence Interval|Number
644151|NCT02219477|Secondary|Percentage of Participants With SVR12 Non-Response Due to Experiencing On-Treatment Virologic Failure|On-treatment virologic failure was defined as: confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment; confirmed increase from nadir in HCV RNA (two consecutive HCV RNA measurements > 1 log˅10 IU/mL above nadir) at any time point during treatment; or HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks (≥ 36 days) of treatment. The 95% confidence interval was calculated using Wilson score method. SVR12 was defined as HCV RNA < LLOQ in the SVR12 window (12 weeks after the last actual dose of study drug) without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window.|Up to 24 weeks during treatment|Intent to treat population: all participants who received at least 1 dose of study drug.||percentage of participants||95% Confidence Interval|Number
644152|NCT02219477|Secondary|Percentage of Participants With SVR12 in Group 3|SVR12, defined as HCV RNA < LLOQ in the SVR12 window (12 weeks after the last actual dose of study drug) without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Flanking imputation: for participants with missing HCV RNA at a visit, who have an undetectable HCV RNA or unquantifiable HCV RNA at the preceding visit and the succeeding visit, the missing value was imputed as undetectable or unquantifiable. For SVR analyses, if there was no value in the window after the flanking imputation but there was an HCV RNA value after the window, then it was imputed into the SVR window. After above imputations were applied, if there was still no value in the window but there was an HCV RNA value from a local laboratory present, then it was imputed into the SVR window. Otherwise, participants with missing data were counted as failures.|12 weeks after the last actual dose of study drug|Intent to treat population: all participants who received at least 1 dose of study drug; participants missing data = non-responders. See imputation details in the outcome measure description.||percentage of participants|||Number
644153|NCT02219477|Primary|Percentages of Participants With Sustained Virologic Response 12 Weeks Post-Treatment (SVR12) in Group 1 and in Group 2|SVR12, defined as HCV RNA < lower limit of quantification (LLOQ) in the SVR12 window (12 weeks after the last actual dose of study drug) without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Flanking imputation: for participants with missing HCV RNA at a visit who have an undetectable HCV RNA or unquantifiable HCV RNA at the preceding visit and the succeeding visit, the missing value was imputed as undetectable or unquantifiable. For SVR analyses, if there was no value in the window after the flanking imputation but there was an HCV RNA value after the window, then it was imputed into the SVR window. After above imputations were applied, if there was still no value in the window but there was an HCV RNA value from a local laboratory present, then it was imputed into the SVR window. Otherwise, participants with missing data were counted as failures. The 95% confidence interval was calculated using the Wilson score method.|12 weeks after the last actual dose of study drug|Intent to treat population: all participants who received at least 1 dose of study drug; participants missing data = non-responders. See imputation details in the outcome measure description.||percentage of participants||95% Confidence Interval|Number
644154|NCT02219464|Secondary|Number of Participants Who Needed Airway Assistance Interventions|(jaw lift, tongue retraction, oral airway placement, mask ventilation, increase in oxygen flow rate, ect.).|During surgical procedure|||Participants|||Count of Participants
644155|NCT02219464|Primary|Number of Participants With Oxygen Saturations Below 92%||During surgical procedure|||Participants|||Count of Participants
644156|NCT02219282|Secondary|Insertion Time of Laryngeal Mask|Duration of insertion (second) Laryngeal Mask;second|During placement of Laryngeal Mask|||seconds||Standard Deviation|Mean
644157|NCT02219282|Secondary|Ease of Placement Laryngeal Mask|Ease (according to Likert scale 1-4 point from easy to diffucult).|During Laryngeal mask placement|||Participants|||Count of Participants
644158|NCT02219282|Secondary|Haemodynamic Response to Insertion of Airway Device.|Mean blood pressure (MBP) (mmHg) were recorded in both groups.|Before anesthesia induction, before laryngeal mask insertion and in the 1st, 2nd, 3rd and 5th minutes after laryngeal mask insertion|||mmHg||Standard Deviation|Mean
644159|NCT02219282|Secondary|Oropharyngeal Leak Pressure|Oropharyngeal leak pressure (cm H20) in dentulous and edentulous elderly patients.|Baseline|||cm H20||Standard Deviation|Mean
644160|NCT02219282|Primary|Number of Participants With Successful Laryngeal Mask Placement|The aim of this study is primarily to measure the success of placement on first try in dentulous and edentulous elderly patients for success of placement on first try.|Baseline|For one patient in each group, dentulous and edentulous, insertion of the LMU was unsuccessful on the third attempt, and these patients were intubated; therefore, these two patients were excluded from the study and were not included in the statistical analysis||Participants|||Count of Participants
644162|NCT02219256|Primary|Number of Participants Who Meet the TDC Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose||First dose up to Day 78|The safety analysis set included all participants who were enrolled, received 1 dose of study drug (after study drug dosing started) inclusive of those participants who did not complete all scheduled study visits.||participants|||Number
644163|NCT02219256|Secondary|Percentage of Participants With Positive Antidrug Antibody (ADA) and Neutralizing Antibody (Nab)|Results for ADA analysis were reported.|Baseline up to Day 78|The safety analysis set included all participants who were enrolled, received 1 dose of study drug (after study drug dosing started) inclusive of those participants who did not complete all scheduled study visits. Due to change in planned analysis testing of NAb activity of ADA positive samples was not analysed.||percentage of participants|||Number
644164|NCT02219256|Secondary|AUC∞: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for TAK-079||Day 1 pre-dose and at multiple time-points (up to Day 78) post-dose|The PK analysis set included all participants who received study drug and had at least 1 measurable serum concentration of TAK-079. PK analysis was performed for TAK-079 0.6 mg/kg SC dose groups only, since serum concentrations of TAK-079 were below the LLOQ at all PK sampling time-points for remaining arms.||ng*day/mL||Standard Deviation|Mean
644165|NCT02219256|Secondary|AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-079||Day 1 pre-dose and at multiple time points (up to Day 78) post-dose|The PK analysis set:all participants who received study drug and had at least 1 measurable serum concentration of TAK-079.A valid AUClast was derived for TAK-079 0.6 mg/kgSC dose group only, since serum concentrations of TAK-079 were either below the LLOQ at all PK sampling time-points or too limited to estimate AUClast reliably for remaining arms.||nanogram*day per milliliter (ng*day/mL)||Standard Deviation|Mean
644166|NCT02219256|Secondary|Cmax: Maximum Observed Serum Concentration for TAK-079||Day 1 pre-dose and at multiple time-points (up to Day 78) post-dose|The pharmacokinetic(PK) analysis set included all participants who received study drug and had at least 1 measurable serum concentration of TAK-079. PK analysis was performed for TAK-079 0.03, 0.06 mg/kg IV and 0.6 SC mg/kg dose groups only, since serum concentrations of TAK-079 were below the LLOQ at all PK sampling time-points for remaining arms.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
644167|NCT02219256|Primary|Number of Participants Who Meet the Takeda Development Centre (TDC) Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose||First dose up to Day 78|The safety analysis set included all participants who were enrolled, received 1 dose of study drug (after study drug dosing started) inclusive of those participants who did not complete all scheduled study visits.||participants|||Number
644168|NCT02219256|Primary|Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. AE was assessed according to severity; mild (transient and easily tolerated by the participant), moderate (causes the participant discomfort and interrupts the participant’s usual activities) and severe (causes considerable interference with the participant’s usual activities).|First dose up to Day 94|The safety analysis set included all participants who were enrolled, received 1 dose of study drug (after study drug dosing started) inclusive of those participants who did not complete all scheduled study visits.||participants|||Number
646405|NCT02146352|Secondary|Technical Success Outcome Measure 1|Technical success: Successful placement of the AXIOS stent using the Electrocautery Enhanced AXIOS Delivery System|Index Procedure|Per Protocol||percentage of patients|||Number
644186|NCT02217280|Primary|Circumferential Contrast Spread|"Number of study subjects who achieved circumferential contrast spread in the epidural space. Circumferential contrast spread is achieved when the contrast reaches all directions in the epidural space in the horizontal/axial plane.
This includes contrast spread in the anterior, posterior, medial and lateral directions (in relation to the spinal cord)."|1 hour|||Participants|||Count of Participants
644187|NCT02217280|Primary|Injection Dispersal Patterns Measured (in cm) in the Superoinferior Directions on Post-injection MRI With a Calibrated Internal Measurement Software.|Determine the relative efficacy (diagnostic and therapeutic) of cervical epidural injections based on injectate diffusion. We will measure (with post-injection MRI) how far the injection travels in the superoinferior directions (in cm) within in the epidural space.|1 hour|||cm||Standard Deviation|Mean
644188|NCT02218307|Secondary|Quality of Life in Chronic Rhinosinusitis Patients|Measuring the quality of life in chronic rhinosinusitis through completion of a questionnaire named Visual Analog Scale for Nasal Obstruction/Congestion. VAS for nasal obstruction is scale from 0 to 100 where 100 mean worse.|3 months|||Units on a scale||Standard Deviation|Mean
644189|NCT02218307|Primary|Quality of Life in Chronic Rhinosinusitis Patients|"Measuring the quality of life in chronic rhinosinusitis through completion of a questionnaire named SNOT 20 ( 20 questions for Sino-Nasal Outcome Test)
Snot20:
Scale 1 to 5 for 20 symptoms numbered below where 5 is the worst symptom. Total SNOT is scale from 0-100 where 100 is the worst.
The following are the elements:
1. need to blow 2. sneezing 3. runny nose 4. cough 5. postnasal drip 6. Thick nasal discharge 7. Ear fullness 8. Dizziness 9. Ear pain 10. facial pain/pressure 11. difficulty falling asleep 12. wake up at night 13. lack of a good night's sleep 14. wake up tired 15. Fatigue 16. Reduced productivity 17. Reduced concentration 18. frustrated/ restless/irritable 19. sad 20. Embarrassed"|3 months|||Units on a scale||Standard Deviation|Mean
644190|NCT02218268|Primary|Determine the Difference Between Acute Effect of a Mixed Meal on Radial Artery Stiffness in Subjects With Type I Diabetes Mellitus Who do and Who do Not Take an Additional Bolus of Insulin.|Determine the difference between acute effect of a mixed meal on radial artery stiffness in subjects with type I diabetes mellitus who do and who do not take an additional bolus of insulin. Radial tonometry is used to calculate the augmentation index (AI). AI is expressed as a percentage of the pulse pressure and represents the difference between the first and second peaks of the central arterial waveform. The stiffer the artery the more positive elevation of the AI and the machine will indicate stiffness using a color indicator (green less stiff and red being stiff). AI is measured using the SphygmoCor VX version 7.01 (AtCor Medical, Syndey, Australia). AI will be corrected to a heart rate of 75 to eliminate differences related to heart rate variation.|From baseline to one hour then 2 hours|||Percent of Pulse Pressure||95% Confidence Interval|Mean
644191|NCT02218216|Primary|mTBI Progression Indicated by Clinical Neurological Characteristics, MRI Images, and Quantitative MRI Data From Novel Software|To determine associations between clinical neurological data, MR images, quantitative data from novel software post-processing (sponsor developed software including Volumetry, Kurtosis, Resting State [RS], functional magnetic resonance imaging [fMRI], and additional post-processing modules may be provided|Baseline to 3 months|Study was terminated and no subject outcome data were collected|||||
644192|NCT02217982|Other Pre-specified|Number of Participants With Pre-Existing GI Conditions|The tertiary objective is to gather further data regarding pre-existing conditions (GE reflex, gastric bypass, stomach ulcer, etc) and their possible relationship to GI symptoms when initiating DMF.|7 Weeks||||||
644193|NCT02217982|Secondary|Diarrhea Reduction|The secondary objective is to assess the reduction in diarrhea in the treatment group compared to the control.|7 Weeks|Not enough patients qualified and the study was terminated early.|||||
644194|NCT02217982|Primary|Reported GI Symptoms|The primary endpoint will be severity of GI events as measured by the MAGIS scale for subjects in the treatment arm compared to the standard therapy arm.|7 Weeks|Trial was shut down early as not enough patients qualified with GI symptoms their first 2 weeks after initiating DMF therapy|||||
644195|NCT02217878|Secondary|Time to Reach Platelet Reactivity Below the Cut-off Value for High Platelet Reactivity Evaluated With VerifyNow|Time to Reach Platelet Reactivity Below the Cut-off Value for High Platelet Reactivity (HPR) Evaluated With VerifyNow|12 hours|In line with the study protocol, VerifyNow pharmacodynamic evaluation involved >30% of the overall study population.||hours||Inter-Quartile Range|Median
644196|NCT02217878|Secondary|Time to Reach Platelet Reactivity Below the Cut-off Value for High Platelet Reactivity Evaluated With MEA|Time to Reach Platelet Reactivity Below the Cut-off Value for High Platelet Reactivity (HPR) Evaluated With MEA|12 hours|According to the study protocol multiple electrode aggregometry pharmacodynamic evaluation was performed in all patients except for those treated with glycoprotein (GP) IIb/IIIa receptor inhibitors.||hours||Inter-Quartile Range|Median
644197|NCT02217878|Secondary|Time to Reach Platelet Reactivity Below the Cut-off Value for High Platelet Reactivity Evaluated With VASP|Time to Reach Platelet Reactivity Below the Cut-off Value for High Platelet Reactivity (HPR) Evaluated With VASP|12 hours|||hours||Inter-Quartile Range|Median
644198|NCT02217878|Secondary|Percentage of Patients With High Platelet Reactivity After the Loading Dose of Ticagrelor Assessed With VerifyNow|Percentage of Patients With High Platelet Reactivity (HPR) After the Loading Dose of Ticagrelor Assessed With VerifyNow|2 hours|In line with the study protocol, VerifyNow pharmacodynamic evaluation involved >30% of the overall study population.||Percentage of Patients With HPR|||Number
644199|NCT02217878|Secondary|Percentage of Patients With High Platelet Reactivity After the Loading Dose of Ticagrelor Assessed With MEA|Percentage of Patients With High Platelet Reactivity (HPR) After the Loading Dose of Ticagrelor Assessed With MEA|2 hours|According to the study protocol multiple electrode aggregometry pharmacodynamic evaluation was performed in all patients except for those treated with glycoprotein (GP) IIb/IIIa receptor inhibitors.||Percentage of Patients With HPR|||Number
644200|NCT02217878|Secondary|Percentage of Patients With High Platelet Reactivity After the Loading Dose of Ticagrelor Assessed With VASP|Percentage of Patients With High Platelet Reactivity (HPR) After the Loading Dose of Ticagrelor Assessed With VASP|2 hours|||Percentage of Patients With HPR|||Number
644201|NCT02217878|Secondary|P2Y12 Reaction Units Assessed by VerifyNow|P2Y12 Reaction Units (PRU) Assessed by VerifyNow (cut-off value for high platelet reactivity: PRU >208)|12 hours post ticagrelor dose|In line with the study protocol, VerifyNow pharmacodynamic evaluation involved >30% of the overall study population.||P2Y12 Reaction Units||Inter-Quartile Range|Median
644202|NCT02217878|Secondary|P2Y12 Reaction Units Assessed by VerifyNow|P2Y12 Reaction Units (PRU) Assessed by VerifyNow (cut-off value for high platelet reactivity: PRU >208)|6 hours post ticagrelor dose|In line with the study protocol, VerifyNow pharmacodynamic evaluation involved >30% of the overall study population.||P2Y12 Reaction Units||Inter-Quartile Range|Median
644203|NCT02217878|Secondary|P2Y12 Reaction Units Assessed by VerifyNow|P2Y12 Reaction Units (PRU) Assessed by VerifyNow (cut-off value for high platelet reactivity: PRU >208)|4 hours post ticagrelor dose|In line with the study protocol, VerifyNow pharmacodynamic evaluation involved >30% of the overall study population.||P2Y12 Reaction Units||Inter-Quartile Range|Median
644204|NCT02217878|Secondary|P2Y12 Reaction Units Assessed by VerifyNow|P2Y12 Reaction Units (PRU) Assessed by VerifyNow (cut-off value for high platelet reactivity: PRU >208)|3 hours post ticagrelor dose|In line with the study protocol, VerifyNow pharmacodynamic evaluation involved >30% of the overall study population.||P2Y12 Reaction Units||Inter-Quartile Range|Median
644205|NCT02217878|Secondary|P2Y12 Reaction Units Assessed by VerifyNow|P2Y12 Reaction Units (PRU) Assessed by VerifyNow (cut-off value for high platelet reactivity: PRU >208)|2 hours post ticagrelor dose|In line with the study protocol, VerifyNow pharmacodynamic evaluation involved >30% of the overall study population.||P2Y12 Reaction Units||Inter-Quartile Range|Median
644206|NCT02217878|Secondary|P2Y12 Reaction Units Assessed by VerifyNow|P2Y12 Reaction Units (PRU) Assessed by VerifyNow (cut-off value for high platelet reactivity: PRU >208)|1 hour post ticagrelor dose|In line with the study protocol, VerifyNow pharmacodynamic evaluation involved >30% of the overall study population.||P2Y12 Reaction Units||Inter-Quartile Range|Median
644207|NCT02217878|Secondary|P2Y12 Reaction Units Assessed by VerifyNow|P2Y12 Reaction Units (PRU) Assessed by VerifyNow (cut-off value for high platelet reactivity: PRU >208)|30 minutes post ticagrelor dose|In line with the study protocol, VerifyNow pharmacodynamic evaluation involved >30% of the overall study population.||P2Y12 Reaction Units||Inter-Quartile Range|Median
644208|NCT02217878|Secondary|P2Y12 Reaction Units Assessed by VerifyNow|P2Y12 Reaction Units (PRU) Assessed by VerifyNow (cut-off value for high platelet reactivity: PRU >208)|prior to the initial ticagrelor dose|In line with the study protocol, VerifyNow pharmacodynamic evaluation involved >30% of the overall study population.||P2Y12 Reaction Units||Inter-Quartile Range|Median
644209|NCT02217878|Secondary|Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry|Platelet reactivity assessed by Multiple Electrode Aggregometry (cut-off value for high platelet reactivity: AUC >46 Platelet Arbitrary Aggregation Units)|12 hours post ticagrelor dose|According to the study protocol multiple electrode aggregometry pharmacodynamic evaluation was performed in all patients except for those treated with glycoprotein (GP) IIb/IIIa receptor inhibitors.||Platelet Arbitrary Aggregation Units||Inter-Quartile Range|Median
644210|NCT02217878|Secondary|Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry|Platelet reactivity assessed by Multiple Electrode Aggregometry (cut-off value for high platelet reactivity: AUC >46 Platelet Arbitrary Aggregation Units)|6 hours post ticagrelor dose|According to the study protocol multiple electrode aggregometry pharmacodynamic evaluation was performed in all patients except for those treated with glycoprotein (GP) IIb/IIIa receptor inhibitors.||Platelet Arbitrary Aggregation Units||Inter-Quartile Range|Median
644211|NCT02217878|Secondary|Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry|Platelet reactivity assessed by Multiple Electrode Aggregometry (cut-off value for high platelet reactivity: AUC >46 Platelet Arbitrary Aggregation Units)|4 hours post ticagrelor dose|According to the study protocol multiple electrode aggregometry pharmacodynamic evaluation was performed in all patients except for those treated with glycoprotein (GP) IIb/IIIa receptor inhibitors.||Platelet Arbitrary Aggregation Units||Inter-Quartile Range|Median
644212|NCT02217878|Secondary|Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry|Platelet reactivity assessed by Multiple Electrode Aggregometry (cut-off value for high platelet reactivity: AUC >46 Platelet Arbitrary Aggregation Units)|3 hours post ticagrelor dose|According to the study protocol multiple electrode aggregometry pharmacodynamic evaluation was performed in all patients except for those treated with glycoprotein (GP) IIb/IIIa receptor inhibitors.||Platelet Arbitrary Aggregation Units||Inter-Quartile Range|Median
644213|NCT02217878|Secondary|Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry|Platelet reactivity assessed by Multiple Electrode Aggregometry (cut-off value for high platelet reactivity: AUC >46 Platelet Arbitrary Aggregation Units)|2 hours post ticagrelor dose|According to the study protocol multiple electrode aggregometry pharmacodynamic evaluation was performed in all patients except for those treated with glycoprotein (GP) IIb/IIIa receptor inhibitors.||Platelet Arbitrary Aggregation Units||Inter-Quartile Range|Median
644214|NCT02217878|Secondary|Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry|Platelet reactivity assessed by Multiple Electrode Aggregometry (cut-off value for high platelet reactivity: AUC >46 Platelet Arbitrary Aggregation Units)|1 hour post ticagrelor dose|According to the study protocol multiple electrode aggregometry pharmacodynamic evaluation was performed in all patients except for those treated with glycoprotein (GP) IIb/IIIa receptor inhibitors.||Platelet Arbitrary Aggregation Units||Inter-Quartile Range|Median
644215|NCT02217878|Secondary|Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry|Platelet reactivity assessed by Multiple Electrode Aggregometry (cut-off value for high platelet reactivity: AUC >46 Platelet Arbitrary Aggregation Units)|30 minutes post ticagrelor dose|According to the study protocol multiple electrode aggregometry pharmacodynamic evaluation was performed in all patients except for those treated with glycoprotein (GP) IIb/IIIa receptor inhibitors.||Platelet Arbitrary Aggregation Units||Inter-Quartile Range|Median
644216|NCT02217878|Secondary|Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry|Platelet reactivity assessed by Multiple Electrode Aggregometry (cut-off value for high platelet reactivity: AUC >46 Platelet Arbitrary Aggregation Units)|prior to the initial ticagrelor dose|According to the study protocol multiple electrode aggregometry pharmacodynamic evaluation was performed in all patients except for those treated with glycoprotein (GP) IIb/IIIa receptor inhibitors.||Platelet Arbitrary Aggregation Units||Inter-Quartile Range|Median
644217|NCT02217878|Secondary|Platelet Reactivity Index Assessed by VASP Assay|Platelet Reactivity Index (PRI) evaluated by VASP assay (cut-off value for high platelet reactivity: PRI >50%)|12 hours post ticagrelor dose|||Platelet Reactivity Index (%)||Inter-Quartile Range|Median
644218|NCT02217878|Secondary|Platelet Reactivity Index Assessed by VASP Assay|Platelet Reactivity Index (PRI) evaluated by VASP assay (cut-off value for high platelet reactivity: PRI >50%)|6 hours post ticagrelor dose|||Platelet Reactivity Index (%)||Inter-Quartile Range|Median
644219|NCT02217878|Secondary|Platelet Reactivity Index Assessed by VASP Assay|Platelet Reactivity Index (PRI) evaluated by VASP assay (cut-off value for high platelet reactivity: PRI >50%)|4 hours post ticagrelor dose|||Platelet Reactivity Index (%)||Inter-Quartile Range|Median
644220|NCT02217878|Secondary|Platelet Reactivity Index Assessed by VASP Assay|Platelet Reactivity Index (PRI) evaluated by VASP assay (cut-off value for high platelet reactivity: PRI >50%)|3 hours post ticagrelor dose|||Platelet Reactivity Index (%)||Inter-Quartile Range|Median
644221|NCT02217878|Secondary|Platelet Reactivity Index Assessed by VASP Assay|Platelet Reactivity Index (PRI) evaluated by VASP assay (cut-off value for high platelet reactivity: PRI >50%)|2 hours post ticagrelor dose|||Platelet Reactivity Index (%)||Inter-Quartile Range|Median
644222|NCT02217878|Secondary|Platelet Reactivity Index Assessed by VASP Assay|Platelet Reactivity Index (PRI) evaluated by VASP assay (cut-off value for high platelet reactivity: PRI >50%)|1 hour post ticagrelor dose|||Platelet Reactivity Index (%)||Inter-Quartile Range|Median
644223|NCT02217878|Secondary|Platelet Reactivity Index Assessed by VASP Assay|Platelet Reactivity Index (PRI) evaluated by VASP assay (cut-off value for high platelet reactivity: PRI >50%)|30 minutes post ticagrelor dose|||Platelet Reactivity Index (%)||Inter-Quartile Range|Median
644224|NCT02217878|Secondary|Platelet Reactivity Index Assessed by VASP Assay|Platelet Reactivity Index (PRI) evaluated by VASP assay (cut-off value for high platelet reactivity: PRI >50%)|prior to the initial ticagrelor dose|||Platelet Reactivity Index (%)||Inter-Quartile Range|Median
644225|NCT02217878|Secondary|Area Under the Plasma Concentration-time Curve for AR-C124910XX (AUC 0-6)|Exposure to ticagrelor metabolite during the first 6 hours after ticagrelor loading dose|prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h post dose|||ng*h/mL||Inter-Quartile Range|Median
644226|NCT02217878|Secondary|Area Under the Plasma Concentration-time Curve for Ticagrelor (AUC 0-6h)|Exposure to ticagrelor during the first 6 hours after ticagrelor loading dose|prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h post dose|||ng*h/mL||Inter-Quartile Range|Median
644227|NCT02217878|Secondary|Time to Maximum Concentration for AR-C124910XX|Time to maximum concentration (Tmax) for AR-C124910XX|12 hours|||hours||Inter-Quartile Range|Median
644228|NCT02217878|Secondary|Time to Maximum Concentration for Ticagrelor|Time to maximum concentration (Tmax) for ticagrelor|12 hours|||hours||Inter-Quartile Range|Median
644229|NCT02217878|Secondary|Maximum Concentration of AR-C124910XX|Maximum concentration (Cmax) of AR-C124910XX|12 hours|||ng/mL||Inter-Quartile Range|Median
644230|NCT02217878|Secondary|Maximum Concentration of Ticagrelor|Maximum concentration (Cmax) of ticagrelor|12 hours|||ng/mL||Standard Deviation|Mean
644231|NCT02217878|Secondary|Area Under the Plasma Concentration-time Curve for AR-C124910XX (AUC 0-12h)|Exposure to ticagrelor metabolite during the first 12 hours after ticagrelor loading dose|prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h, 12h post dose|||ng*h/mL||Standard Deviation|Mean
644232|NCT02217878|Primary|Area Under the Plasma Concentration-time Curve for Ticagrelor (AUC 0-12h)|Exposure to ticagrelor during the first 12 hours after ticagrelor loading dose|prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h, 12h post dose|||ng*h/mL||Standard Deviation|Mean
644233|NCT02216695|Secondary|Mortality From Acute Kidney Injury in Each Five-year Period From 1998 to 2013|The secondary objective is evaluate factors affecting mortality due to acute kidney injury in the fifteen year period between 1998 and 2013.|Participants will be followed for the duration of hospital stay (average 13 days)|||participants|||Number
644234|NCT02216695|Secondary|Mortality From Acute Kidney Injury in Each Age Group From 1998 to 2013|The secondary objective is evaluate factors affecting mortality due to acute kidney injury in the fifteen year period between 1998 and 2013.|Participants will be followed for the duration of hospital stay (average 13 days)|||participants|||Number
644312|NCT02214186|Primary|Renal Function in Severe Preeclampsia With Restrictive Fluid Therapy|Renal function evaluated through creatinine levels in three moments: preoperative, first and second postoperative days.|preoperative, first and second day postoperative|Were included in the analysis the patients who violated the protocol and lost follow-up (intention to treat analysis)||mg/dl||Inter-Quartile Range|Median
644235|NCT02216695|Primary|Incidence of AKI-D From 1998-9 to 2012-13|The population incidence of acute kidney injury requiring dialysis (AKI-D) was calculated using mid-year population of England in each year from 1998 to 2013 and expressed as people per million population. This was calculated by dividing number of cases by mid year population of England and multiplying by million.|15-years|||cases per million population|||Number
644236|NCT02216695|Primary|Secular Trends in the Mortality After Acute Kidney Injury From 1998 to 2013|A retrospective cohort study of patients with acute kidney injury in England over a period of fifteen years, describing the trends in the mortality of acute kidney injury.|Participants will be followed for the duration of hospital stay (average of 15 days)|||participants|||Number
644237|NCT02216591|Other Pre-specified|Change in Mean Percent Adherence Across All Antiretroviral Medications||Baseline and 10 weeks|||Percent of doses||Standard Deviation|Mean
644238|NCT02216591|Secondary|Change in Delay Discounting|Measured by Monetary-Choice Questionnaire (MCQ), a standardized task that measures delay discounting. Participants are presented with choices between smaller, immediate rewards and larger, delayed rewards (e.g., “Would you prefer $54 today or $80 in 30 days?). Participants’ hyperbolic discount parameter (k value) is determined by fitting data to the following discount function equation: Vimmediate = Vdelayed / (1 + kD), in which V is the reward value in dollars and D is delay in days. K-values on this scale can range from 0.00016 to 4.00 and to normalize scores, these values were ranked from 1 to 13 for analyses. A higher rank indicates greater delay discounting.|Baseline and 10 weeks|||Mean K value rank for MCQ||Standard Deviation|Mean
644239|NCT02216591|Primary|Change in Working Memory|Standardized neuropsychological tests of working memory used in this study were the Paced Auditory Serial Addition Task-50 and Neuropsychological Assessment Battery Digits Forward/Digits Backward Test. Using the most up-to-date published normative data, raw test scores were converted to T-scores that corrected for demographic factors such as age and education. T scores can range from 0 to 100, with 50 being average and higher scores indicating better function. The overall working memory score was computed by averaging T-scores of each of the individual tests. To examine intervention effects on working memory outcomes, we conducted a 2 (Arm: ACT vs. CON) × 2 (Time: Baseline vs. Post) mixed-model general linear model analyses. Time was the within-subjects factor defined by baseline versus 10 week follow-up, and study arm was the between-subjects factor. Age and years of education were included as covariates. The means reported here are the mean scores at 10 weeks.|Baseline and 10 weeks|||mean T score on working memory tests||Standard Error|Mean
644240|NCT02216422|Secondary|Percentage of Participants With Post-Treatment Relapse|Post- Treatment Relapse is defined as confirmed HCV RNA >= LLOQ between end of treatment and 12 weeks after last actual dose of active study drug [up to and including the SVR12 assessment time point] for a participant with HCV RNA < LLOQ at Final Treatment Visit who completes treatment.|Post-treatment Day 1 to Post-treatment Week 12|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).||percentage of participants||95% Confidence Interval|Number
644241|NCT02216422|Secondary|Percentage of Participants With On-Treatment Virologic Failure|On-Treatment Virologic Failure is defined as confirmed HCV RNA >= LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase from nadir (local minimum value) in HCV RNA [2 consecutive HCV RNA measurements > 1 log10 IU/mL above nadir] at any time point during treatment, or failure to suppress during treatment [all on-treatment values of HCV RNA >= LLOQ] with at least 6 weeks [defined as active study drug duration ≥ 36 days] of treatment.|Day 1 through Week 12|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).||percentage of participants||95% Confidence Interval|Number
644242|NCT02216422|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment|Sustained Virologic Response 12 (SVR12) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (< LLOQ; < 25 IU/mL) 12 weeks after the last dose of study drug. Participants with missing data were imputed as failures.|Post-treatment Day 1 to Post-treatment Week 12|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).||percentage of participants||95% Confidence Interval|Number
644243|NCT02216357|Secondary|Proportion of Patients With an Aspirin Desensitization Dose Level of 30 mg, 60 mg, 100 mg, 150 mg, and 325 mg.||Study Day 2 and 3|||Participants|||Count of Participants
644244|NCT02216357|Secondary|Incidence and Severity of Asthmatic Reactions During the Treatment Period||Study Day 1 through 3|||Participants|||Count of Participants
644245|NCT02216357|Secondary|Amount of Rescue Medication Required During the Aspirin Challenge|The amount of rescue medication required during the aspirin challenge|Study Day 2 and 3|||number of rescue medications||Standard Deviation|Mean
644246|NCT02216357|Secondary|Proportion of Patients With a ≥ 25% Increase in TNSS Compared to Baseline During the Aspirin Challenge||Study Day 2 and 3|||Participants|||Count of Participants
644247|NCT02216357|Secondary|Proportion of Patients With a ≥ 25% Decrease in Peak Nasal Inspiratory Flow Rate (NIFR) Compared to Baseline During the Aspirin Challenge||Study Day 2 and 3|||Participants|||Count of Participants
644248|NCT02216357|Secondary|Proportion of Patients Who Experience a ≥ 20% Decrease in FEV1 Compared to Baseline During the Aspirin Challenge||Study Day 2 and 3|||Participants|||Count of Participants
644249|NCT02216357|Secondary|Incidence and Severity of Treatment-emergent Adverse Events||Up to Study Day 7|Number of subject reporting at least one adverse event||Participants|||Count of Participants
644250|NCT02216357|Secondary|Proportion of Patients With a ≥ 25% Increase in Total Nasal Symptom Score (TNSS) Compared to Baseline Following a Dose of IMP (Study Day 1 or 2) Prior to Initiation of the Aspirin Challenge||Up to Study Day 2|||Participants|||Count of Participants
644251|NCT02216357|Secondary|Proportion of Patients With a ≥ 25% Decrease in Peak Nasal Inspiratory Flow Rate Compared to Baseline Following a Dose of IMP (Study Day 1 or 2) Prior to Initiation of the Aspirin Challenge||Up to Study Day 2|||Participants|||Count of Participants
644252|NCT02216357|Primary|Proportion of Patients Who Experience a ≥ 20% Decrease in Forced Expiratory Volume in One Second (FEV1) Compared to Baseline Following a Dose of Investigational Medicinal Product (IMP) (Study Day 1 or 2) Prior to Initiation of the Aspirin Challenge||Study Day 2|||Participants|||Count of Participants
644253|NCT02216097|Secondary|Number of Participants With Post-Baseline Electrocardiogram (ECG) Values Meeting Criteria of Potential Clinical Concern|ECG criteria of potential clinical concern were QTc absolute value >=450 milliseconds (msec) or QTc absolute change >=30 msec.|Baseline up to Day 18|The safety analysis population included all participants who received study medication.||participants|||Number
644254|NCT02216097|Secondary|Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern|Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: supine pulse rate <40 or >120 beats per minute (bpm), standing pulse rate <40 or >140 bpm; systolic blood pressure (SBP) of >=30 millimeters of mercury (mmHg) change from baseline or SBP <90 mmHg; diastolic blood pressure (DBP) >=20 mmHg change from baseline or DBP <50 mmHg.|Baseline up to Day 18|The safety analysis population included all participants who received study medication.||participants|||Number
644255|NCT02216097|Secondary|Number of Participants With Clinical Laboratory Values Meeting Criteria for Potential Clinical Concern|The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell count, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes; liver function (aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, albumin, total protein); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (sodium, potassium, chloride, calcium, bicarbonate); chemistry (glucose); urinalysis (dipstick) (urine pH, urine glucose, urine protein, urine blood, urine ketones, urine bilirubin, urine nitrite, urine leukocyte esterase); urinalysis microscopy (urine red blood cell, urine white blood cell, urine bacteria). Only parameters with abnormal values were reported.|Baseline up to Day 18|The safety analysis population included all participants who received study medication.||participants|||Number
644256|NCT02216097|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Withdrawals Due to AEs|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last study drug administration that were absent before treatment or that worsened relative to pretreatment state. AEs included non-serious AEs and SAEs.|Baseline up to 28 days after last study drug administration (Day 35)|The safety analysis population included all participants who received study medication.||participants|||Number
644257|NCT02216097|Secondary|Number of Participants With Abnormal Physical Examination Findings|The full physical examination included head, ears, eyes, nose, mouth, skin, heart, and lung examinations, lymph nodes, gastrointestinal, skeletal, and neurological systems.|Baseline to up to Day 18|The safety analysis population included all participants who received study medication.||participants|||Number
644258|NCT02216097|Secondary|Change From Baseline in BOLD fMRI Percent Signal Change in Fearful Versus Neutral Face Contrast in Left Amygdala|Difference measured in BOLD fMRI percent signal change in the left amygdala in fearful versus neutral faces during face processing task.|Baseline, Day 8|There were no efficacy evaluations done in this study because of a change in the planned analysis after the study was prematurely terminated due to GCP non-compliance that resulted in data integrity and quality issues.|||||
644259|NCT02216097|Secondary|Change From Baseline in BOLD fMRI Percent Signal Change in Fearful Versus Neutral Face Contrast in Right Amygdala|Difference measured in BOLD fMRI percent signal change in the right amygdala in fear versus neutral faces during the emotional face processing task.|Baseline, Day 8|There were no efficacy evaluations done in this study because of a change in the planned analysis after the study was prematurely terminated due to GCP non-compliance that resulted in data integrity and quality issues.|||||
644260|NCT02216097|Secondary|Change From Baseline in BOLD fMRI Percent Activation in Bilateral Ventromedial Pre-Frontal Cortex (vmPFC)|Difference measured in BOLD fMRI percent activation in the bilateral vmPFC during the fear extinction recall phase of the fear extinction paradigm.|Baseline, Day 2|There were no efficacy evaluations done in this study because of a change in the planned analysis after the study was prematurely terminated due to GCP non-compliance that resulted in data integrity and quality issues.|||||
644261|NCT02216097|Primary|Change From Baseline Blood-Oxygen-Level Dependent (BOLD) Functional Magnetic Resonance Imaging fMRI) Percent Signal Change in Fearful Versus Neutral Face Contrast in Bilateral Amygdala|Baseline BOLD fMRI percent signal change measured from baseline in fearful versus neutral face contrast during the emotional face processing task in bilateral amygdala.|Baseline, Day 8|There were no efficacy evaluations done in this study because of a change in the planned analysis after the study was prematurely terminated due to Good Clinical Practice (GCP) non-compliance that resulted in data integrity and quality issues.|||||
644262|NCT02215954|Secondary|Evaluation of Acceptability of the Investigational Medicinal Products (IMPs) by Subjects Using a Questionnaire|"The frequency of the response for yes/no questions was summarized in each of question for each treatment arm.
Whether or not a subject will request for the assigned IMPs again when the next colonoscopy is needed, with yes-or-no answer
Whether or not a subject will refuse the assigned IMPs when it is prescribed for the next colonoscopy, with yes-or-no answer"|Day 0 - Day 1|Intention-To-Treat Analysis set||percentage of participants||95% Confidence Interval|Number
644263|NCT02215954|Secondary|Evaluation of Acceptability of the Investigational Medicinal Products (IMPs) by Subjects Using a Questionnaire|"The mean score of subjects who gave favourable impression on their assigned IMPs with 3 or 5 points scales, and the frequency of the response for yes/no questions was summarized in each of question for each treatment arm.
Ease of consuming the assigned IMPs with a scale of 1(Very easy) to 5 (Very difficult)
Overall impression of the assigned IMPs with a scale of 1(Excellent) to 5 (Bad)
Taste of the assigned IMPs with a scale of 1 (Excellent) to 5 (Bad)
Volume of the assigned IMPs with a scale of 1(Very much) to 3 (No problem)
Impression of the assigned IMPs compared with other colon cleansing products with a scale of 1 (Much better) to 5 (Much worse)"|Day 0 - Day 1|Intention-To-Treat Analysis set||units on a scale||95% Confidence Interval|Mean
644264|NCT02215954|Secondary|The Total Scores of the Colon Cleansing Effect by the Investigators at Sites Using the Ottawa Scale|The total Ottawa scale score was calculated by adding the ratings (0 to 4) for each of the three colon segments, Ascending colon (ascending, cecum), Mid colon (transverse, descending), and Recto-sigmoid colon, in addition to the overall fluid quantity rating (0 (small), 1 (medium), or 2 (large) ). This gave a sum of 0 (best) to 12 (worst) for overall assessment of colon cleansing, and an additional 0 to 2 for the global fluid quantity rating. The final range of the score was from 0 (excellent) to 14 (solid stool in each colon segment and lots of fluid).|Day 1 (day of colonoscopy)|Intention-To-Treat Analysis set||units on a scale||95% Confidence Interval|Mean
644265|NCT02215954|Secondary|The Efficacy Rate Based on the Overall Colon Cleansing Effect Assessed by the Investigators at the Sites Using the Japanese Colon Cleansing Scale|The efficacy rate was based on the overall colon cleansing effect as assessed by the investigators at sites: the rate of responders who were defined as subjects with a 1 or 2 rating in each colon segment on the Japanese colon cleansing scale, which has scale of 1 (Excellent observation) to 5 (Unable to judge). One of the 5 ratings to each of the colon segments (rectum, sigmoid colon, descending colon, transverse colon, and ascending colon/cecum) was given according to the description and the representative pictures of each rating. A subject who had a 1 or 2 rating in each colon segment was counted as a responder in the overall colon cleansing effect. Otherwise they were counted as a non-responder.|Day 1 (day of colonoscopy)|Intention-To-Treat Analysis set||percentage of participants|||Number
644266|NCT02215954|Primary|The Efficacy Rate Based on the Overall Colon Cleansing Effect as Assessed by the Independent Central Judging Committee Using the Japanese Colon Cleansing Scale|The efficacy rate was based on the overall colon cleansing effect as assessed by the independent central judging committee: the rate of responders who were defined as subjects with a 1 or 2 rating in each colon segment on the Japanese colon cleansing scale, which has scale of 1 (Excellent observation) to 5 (Unable to judge). One of the 5 ratings to each of the colon segments (rectum, sigmoid colon, descending colon, transverse colon, and ascending colon/cecum) was given according to the description and the representative pictures of each rating. A subject who had a 1 or 2 rating in each colon segment was counted as a responder in the overall colon cleansing effect. Otherwise they were counted as a non-responder.|Day 1 (day of colonoscopy)|Intention-To-Treat Analysis set||percentage of participants|||Number
644267|NCT02215252|Secondary|Plasma Concentration of PF-05089771|All participants in this group were analysed. Only plasma PK concentration of PF-05089771 was analysed.|Baseline, Week 2 and Week 4|The PK concentration analysis set included all randomized participants who received at least one dose of study medication and who had at least 1 measurable concentration.||ng/ml||Standard Deviation|Mean
644268|NCT02215252|Secondary|Fasted Low Density Lipoprotein (LDL) Cholesterol|Percentage Change from Baseline in LDL cholesterol Friedewald by PEG|Baseline, Week 2 and Week 4|The safety analysis set included all participants who receive at least 1 dose of study medication.||Perecent change||Standard Deviation|Mean
644269|NCT02215252|Secondary|Fasted Total Cholesterol Values|Percentage Change from Baseline in Fasted Total Cholesterol values|Baseline, Week 2 and Week 4|The safety analysis set included all participants who receive at least 1 dose of study medication.||Percent change||Standard Deviation|Mean
644270|NCT02215252|Secondary|Number of Participants With Laboratory Test Values of Potential Clinical Importance|The total number of participants with laboratory test abnormalities (without regard to baseline abnormality) was assessed. Clinical laboratory tests included hematology, chemistry, urinalysis and some other tests.|Screening, Day 1, Day 15 and Day 29|The safety analysis set included all participants who receive at least 1 dose of study medication.||Participants|||Number
644271|NCT02215252|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to Adverse Events (AEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect.|Screening to Day 36, and Day 64|The safety analysis set included all participants who receive at least 1 dose of study medication.||Participants|||Number
644272|NCT02215252|Secondary|Number of Days Participants Take Rescue Medication|Number of days participants take rescue medication per week.|Baseline, Week 1, Week 2, Week 3 and Week 4|The full analysis set included all randomized participants who received at least one dose of study medication.||days||Standard Deviation|Mean
644273|NCT02215252|Secondary|Total Amount of Rescue Medication Per Week|Total amount of rescue medication participants take per week|Baseline, Week 1, Week 2, Week 3, and Week 4|The full analysis set included all randomized participants who received at least one dose of study medication.||mg||Standard Deviation|Mean
644274|NCT02215252|Secondary|Daily Sleep Interference Scale Score (DSIS).|Participant rated 11-point Likert scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication. This score was measured as a weekly average.|Baseline, Week 1, Week 2, Week 3 and Week 4|The full analysis set included all randomized participants who received at least one dose of study medication.||number on a scale||Standard Deviation|Mean
644275|NCT02215252|Secondary|Patient’s Global Impression of Change Score (PGIC).|"Participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse) at week 4. The PGIC was combined to produce a 3-point scale, Improved, No Change and Worse."|Baseline, Week 2, and Week 4|The full analysis set included all randomized participants who received at least one dose of study medication.||Number of participants|||Number
644276|NCT02215252|Secondary|Neuropathic Pain Symptom Inventory (NPSI) - Total Score|Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.|Baseline, Week 2 and Week 4|The full analysis set included all randomized participants who received at least one dose of study medication.||Unit on a scale||Standard Deviation|Mean
644277|NCT02215252|Secondary|Neuropathic Pain Symptom Inventory (NPSI) - Paresthesia/Dysethesia|Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.|Baseline, Week 2 and Week 4|The full analysis set included all randomized participants who received at least one dose of study medication.||Unit on a scale||Standard Deviation|Mean
644278|NCT02215252|Secondary|Neuropathic Pain Symptom Inventory (NPSI) - Evoked Pain|Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.|Baseline, Week 2 and Week 4|The full analysis set included all randomized participants who received at least one dose of study medication.||Unit on a scale||Standard Deviation|Mean
644279|NCT02215252|Secondary|Neuropathic Pain Symptom Inventory (NPSI) - Paroxysmal Pain|Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.|Baseline, Week 2, and Week 4|The full analysis set included all randomized participants who received at least one dose of study medication.||Unit on a scale||Standard Deviation|Mean
644280|NCT02215252|Secondary|Neuropathic Pain Symptom Inventory (NPSI) - Pressing (Deep) Spontaneous Pain|Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.|Baseline, Week 2 and Week 4|The full analysis set included all randomized participants who received at least one dose of study medication.||Unit on a scale||Standard Deviation|Mean
644281|NCT02215252|Secondary|Neuropathic Pain Symptom Inventory (NPSI) - Burning (Superficial) Spontaneous Pain|Participants rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.|Baseline, Week 2, and Week 4|The full analysis set included all randomized participants who received at least one dose of study medication.||Unit on a scale||Standard Deviation|Mean
644282|NCT02215252|Secondary|Responder Rate Based on a 50% Improvement in Mean Pain Response Using the Daily Pain NRS Score|Percentage of participants that received ≥50% improvement from baseline in mean pain response (from the daily pain diary).|Baseline, Week 1, Week 2, Week 3, and Week 4|The full analysis set included all randomized participants who received at least one dose of study medication.||Percentage of participants|||Number
644283|NCT02215252|Secondary|Responder Rate Based on a 30% Improvement in Mean Pain Response Using the Daily Pain NRS Score|Percentage of participants that received ≥30% improvement from baseline in mean pain response (from the daily pain diary).|Baseline, Week 1, Week 2, Week 3 and Week 4|The full analysis set included all randomized participants who received at least one dose of study medication.||Percentage of participants|||Number
644284|NCT02215252|Primary|Daily Pain Numeric Rating Scale (NRS)|The endpoint average pain score, based on the mean of the last 7 days’ daily pain numeric rating scale (NRS) scores at (NRS is an 11-point scale where 0 = no pain and 10 = worst possible pain) from the daily pain diaries while receiving study medication during the treatment period.|Baseline, Week 1, Week 2, Week 3 and Week 4|The full analysis set included all randomized participants who received at least one dose of study medication.||Unit on a scale||Standard Deviation|Mean
644285|NCT02214615|Secondary|Carbamazepine Affects Mean Duration of Pain Episode||15 days|||minutes|||Number
644286|NCT02214615|Primary|Carbamazepine Affects Pain in Patients With S241T NaV1.7 IEM Mutation||15 days|||minutes|||Number
644287|NCT02214238|Secondary|PAP Compliance|Participants therapy utilisation will be compared between the two devices using the device data download, and the independent pressure-flow logger.|After 1 night in the sleep lab and 3 weeks use of the device in the home.|The overall number of participants analyzed is represented independent to which arm the participant started. Out of 49 total patients at baseline, 31 had usable data for analysis after using both devices. Compliance was compared between devices independent of which order the participants used each device.||Minutes||Standard Deviation|Mean
644288|NCT02214238|Secondary|PAP Treatment Comfort|Participants will be administered comfort questionnaires regarding the comfort of all devices. The range of responses is 1 to 5 with 1 being very uncomfortable to 5 being very comfortable.|After 1 night in the sleep lab and 3 weeks use of the device in the home.|The overall number of participants analyzed is represented independent to which arm the participant started. Out of 49 total patients at baseline, 35 had usable data for analysis after using each device. PAP treatment comfort was compared between devices independent of which order the participants used each device.||Units on a Scale||Full Range|Median
644289|NCT02214238|Primary|PAP Treatment Efficacy|The participants apnea hypopnea index (AHI) will be assessed using the PSG data, device download data and the independent pressure-flow logger. The apnea-hypopnea index is the total number of sleep disordered breathing events divided by total sleep time.|After 1 night in the sleep lab and 3 weeks use of the device in the home.|The overall number of participants analyzed is represented independent to which arm the participant started. Out of 49 total patients at baseline, 37 had usable data for analysis after using each device. AHI was compared between devices independent of which order the participants used each device.||Events per hour||Standard Deviation|Mean
644290|NCT02214225|Secondary|The Frequency of Serious Adverse Events (SAEs) for 6 Months Following Vaccination.|The number of participants reporting Serious Adverse Events for 6 months following vaccination.|For 6 months following vaccination.|The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.||participants|||Number
644291|NCT02214225|Secondary|The Frequency and Severity of Unsolicited AEs.|The overall number of subjects experiencing at least one event of an unsolicited AE, and the overall number of subjects with at least one severe (grade 3) unsolicited AE.|For 28 days following vaccination.|The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.||participants|||Number
644292|NCT02214225|Secondary|The Frequency of Cellulitis-like Reaction and Cellulitis.|The number of subjects experiencing at least one episode of each event.|For 28 days following vaccination.|The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.||participants|||Number
644293|NCT02214225|Secondary|The Frequency and Severity of Solicited Local and Systemic Adverse Events (AEs).|The overall number of subjects experiencing at least one event of a local and systemic solicited AE, and the overall number of subjects with at least one severe (grade 3) local and systemic solicited AE.|For 7 days following vaccination.|The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.||participants|||Number
644294|NCT02214225|Secondary|Seroconversion Rates|The immunogenicity of bioCSL QIV, bioCSL TIV-1 and bio CSL TIV-2 was assessed in terms of the seroconversion rate, ie, percentage of subjects with either a prevaccination HI titer < 1:10 and a postvaccination HI titer ≥ 1:40, or a prevaccination titer ≥ 1:10 and a ≥ 4-fold increase in post-vaccination titer. Data presented in age cohorts (per protocol population).|21 days after vaccination.|The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.||percentage of participants||95% Confidence Interval|Number
644295|NCT02214225|Secondary|Seroprotection Rates Prevaccination and Postvaccination.|The immunogenicity of bioCSL QIV, bioCSL TIV-1 and bioCSL TIV-2 was assessed in terms of percentage of subjects with a HI titer ≥40 (seroprotection rates) prevaccination (Day 1) and postvaccination (Day 21), in age cohorts (per protocol population).|21 days after vaccination.|The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.||percentage of participants||95% Confidence Interval|Number
644296|NCT02214225|Secondary|Geometric Mean Fold Titer Change From Prevaccination to Postvaccination.|The immunogenicity of bioCSL QIV, bioCSL TIV-1 and bioCSL TIV-2 assessed in terms of Geometric Mean Fold Increase (GMFI, defined as the geometric mean of the fold increases of postvaccination antibody titer over the prevaccination antibody titer) by Age Cohort (Per Protocol Population).|21 days after vaccination.|The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.||Fold Change Titer (GMFI)||95% Confidence Interval|Geometric Mean
644297|NCT02214225|Secondary|Geometric Mean of HI Titers (GMTs) Prevaccination and Postvaccination.|The immunogenicity of bioCSL QIV, bioCSL TIV-1 and bioCSL TIV-2 was assessed in terms of geometric mean HI titers (GMT) prevaccination (Day 1) and postvaccination (Day 21), in age cohorts (per protocol population).|21 days after vaccination.|The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.||Titer||95% Confidence Interval|Geometric Mean
644298|NCT02214225|Secondary|Immunologic Superiority of the Alternate B Strain in bioCSL QIV, as Determined by Seroconversion Rate (SCR) (Statistical Analysis: Difference in SCR) for This Strain, Overall and by Age Cohort (Per Protocol Population)|Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to < 65 years and ≥ 65 years of age), and overall. The SCR difference was calculated as bioCSL QIV SCR minus bioCSL TIV SCR, which is the reverse of how it was calculated for the non-inferiority analyses. For the SCR comparison superiority was demonstrated if the lower limit of the two-sided 95% CI of the difference of the seroconversion rates was greater than 0 for each B strain in QIV compared with the corresponding B strain not contained in each TIV.|21 days after vaccination.|The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.||percentage of participants analyzed|||Number
644299|NCT02214225|Secondary|Immunologic Superiority of the Alternate B Strain in bioCSL QIV, as Determined by the GMT (Statistical Analysis: GMT Ratio) for This Strain, Overall and by Age Cohort (Per Protocol Population).|"Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to < 65 years and ≥ 65 years of age), and overall. The GMT ratio was calculated as bioCSL QIV GMT/bioCSL TIV GMT for the superiority analyses, which is the reverse of how it was calculated for the non-inferiority analyses.
(GMT dispersion values are based on unadjusted GMT values.)"|21 days after vaccination.|The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.||Titer||Full Range|Geometric Mean
644331|NCT02213250|Secondary|Number of Participants With Inhibitor Development||From the subject provided informed consent through and including 28 calendar days after the last administration of the study drug.|The safety analysis population included All participants who received at least 1 dose of BeneFIX.||Participants|||Number
644300|NCT02214225|Secondary|The Seroconversion Rate (SCR) (Statistical Analyses: Difference in SCR) for Each Virus Strain, Assessed Separately Within Each Age Group (18 to < 65 Years and ≥ 65 Years of Age) (Per Protocol Population).|Non-inferiority of bioCSL QIV compared to bioCSL TIV-1, and to bioCSL TIV-2 was assessed separately within each age group (18 to < 65 years and ≥ 65 years of age) through assessment of SCR differences as described for the primary endpoint.|21 days after vaccination.|The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.||percentage of participants analyzed|||Number
644301|NCT02214225|Secondary|Postvaccination GMT (Statistical Analyses: GMT Ratios) Assessed Separately Within Each Age Group (18 Through 64 Years and ≥ 65 Years of Age) (Per-Protocol Population).|"Immunogenicity was assessed by measuring HI titers to the four virus strains. Postvaccination GMTs were determined. (GMT dispersion values are based on unadjusted GMT values.) The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was then determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.
Non-inferiority of bioCSL QIV compared to bioCSL TIV-1, and to bioCSL TIV-2 was assessed separately within each age group (18 to < 65 years and ≥ 65 years of age) through assessment of GMT ratios as described for the primary endpoint."|21 days after vaccination.|The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.||Titer||Full Range|Geometric Mean
644302|NCT02214225|Primary|The Seroconversion Rate (SCR) (Statistical Analysis: Difference in SCR) in Subjects Aged ≥18 Years.|SCR (defined as the percentage of subjects with either a prevaccination HI titer < 1:10 and a postvaccination HI titer ≥ 1:40 or a prevaccination HI titer ≥ 1:10 and a 4-fold increase in postvaccination HI titer) was determined for each virus strain included in the vaccines: bioCSL TIV-1 and bioCSL TIV-2 SCRs were pooled for analysis of the A strains. The SCR difference was defined as the SCR percentage for bioCSL Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus the SCR percentage for bioCSL QIV.|21 days after vaccination.|The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.||percentage of participants|||Number
644303|NCT02214225|Primary|Postvaccination Geometric Mean Titer (GMT) (Statistical Analysis: GMT Ratios) in Subjects Aged ≥18 Years (Per Protocol Population).|Immunogenicity was assessed by measuring HI titers to the four virus strains. Postvaccination GMTs were determined. (GMT dispersion values are based on unadjusted GMT values.) The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was then determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.|21 days after vaccination.|The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.||Titer||Full Range|Geometric Mean
644304|NCT02214186|Primary|Postoperative Renal Dysfunction Evaluated by the Acute Kidney Injury Network (AKIN) Index|Renal dysfunction was stratified by the Acute Kidney Injury Network (AKIN) index in three stages, in terms of creatinine increase from baseline: stage 1 included an interval of 150–200%, stage 2 200%–300%, and stage 3 more than 300% or hemodialysis|Postoperative renal dysfunction|||participants|||Number
644305|NCT02214186|Secondary|Activated Partial Thromboplastin Time in Restrictive Fluid Management of Severe Preeclampsia During Cesarean Section|"Compare activated partial thromboplastin time (APPT) and relation with control (R) in the restrictive and liberal groups.
APPT is a laboratory test that evaluates the efficiency of the intrinsic pathway of coagulation. The unit of measure is seconds and the results are presented as relation (R) with control."|preoperative, first and second day postoperative|The values are expressed in seconds and presented as a ration (R) with control patients.||ratio||Standard Deviation|Mean
644306|NCT02214186|Other Pre-specified|Urine Output During Cesarean Section in Severe Pre-eclampsia|Urine output during cesarean section in severe pre-eclampsia under two different regimes of hydration (restrictive and liberal)|urine output during cesarean section (an average of 60 minutes)|||ml/h||Inter-Quartile Range|Median
644307|NCT02214186|Secondary|International Normalized Ratio (INR) of Prothrombin Time (PT) in Restrictive Fluid Management of Severe Preeclampsia During Cesarean Section|"Compare International Normalized Ratio (INR) of Prothrombin Time (PT) in the restrictive and liberal groups in preoperative, first and second day postoperative.
PT is expressed in seconds and the entered values represented the INR of PT among study participants and a control population."|preoperative, first and second day postoperative|The values are expressed in seconds and presented as a ration (INR) with control patients.||ratio||Inter-Quartile Range|Median
644308|NCT02214186|Secondary|Platelets in Restrictive Fluid Management of Severe Preeclampsia|Compare platelets count in the restrictive and liberal groups during the first and second post-operative days.|preoperative, first and second day postoperative|||thrombocytes/mm3||Standard Deviation|Mean
644309|NCT02214186|Secondary|Proteinuria in Severe Pre-eclampsia Submitted to Cesarean Section Under Different Regimes of Hydration|Proteinuria in severe pre-eclampsia submitted to cesarean section under different regimes of hydration. Analyses in pre-operative and post-operative period.|Proteinuria in severe pre-eclampsia in in pre-operative and post-operative period|||g/dl||Inter-Quartile Range|Median
644310|NCT02214186|Secondary|Cystatin C as New Marker of Renal Injury in Preeclampsia|Evaluate new marker of renal injury (Cystatin C) in the specific population of patients with severe preeclampsia, comparing the values of first and second postoperative days to baseline.|preoperative, first and second day postoperative|||mg/L||Standard Deviation|Mean
644311|NCT02214186|Secondary|Neutrophil Gelatinase-associated Lipocalin (NGAL) as New Marker of Renal Injury in Preeclampsia|Evaluate new marker of renal injury (NGAL) in the specific population of patients with severe preeclampsia, comparing the values of first and second postoperative days to baseline.|preoperative, first and second day postoperative|||mg/L||Inter-Quartile Range|Median
644313|NCT02213900|Secondary|Efficacy of Low-dose Haloperidol in Reducing Cognitive Impairment at Post-operative Follow-up|Test the efficacy of low dose haloperidol in reducing cognitive impairment at post-operative follow-up among patients who are status post esophagectomy, pneumonectomy or thoracotomy compared to placebo. Cognitive status is assessed using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). The RBANS measures attention, language, visuospatial/constructional abilities, and memory. It is made up of 12 subtests. The subtests produce 5 index scores and a total scale score. All the subtest scores are summed to calculate a Total Index score. The Total Index score is presented. The Total Index score scale is from 0-100 with higher scores indicating less cognitive impairment.|Up to 3 months after hospital discharge on average.|||Units on a scale||Standard Deviation|Mean
644314|NCT02213900|Secondary|Efficacy of Low-dose Haloperidol in Reducing ICU and Hospital Length of Stay|Test the efficacy of low dose haloperidol in reducing ICU and hospital length of stay among patients who are status post esophagectomy or pneumonectomy compared to placebo.|Date of hospital admission through date of hospital discharge, up to 3 weeks on average.|||Days||Standard Deviation|Mean
644315|NCT02213900|Secondary|Efficacy of Low-dose Haloperidol in Reducing Days With Delirium|Test the efficacy of low dose haloperidol in reducing the number of days with delirium among patients who are status post esophagectomy, pneumonectomy or thoracotomy compared to placebo.|Up to 30 days|||Days with Delirium||Standard Deviation|Mean
644316|NCT02213900|Primary|Efficacy of Low-dose Haloperidol in Reducing Delirium Incidence|Test the efficacy of low dose haloperidol in reducing delirium incidence among patients who are status post esophagectomy, pneumonectomy or thoracotomy compared to placebo.|Up to 30 days|||Participants|||Count of Participants
644317|NCT02213666|Primary|Intracardiac and Transesophageal Echo Results|The right atrial appendage (RAA) and left atrial appendage (LAA) will be assessed for the presence or absence of intracardiac thrombi with the Siemens AcuNav Ultrasound catheter. This is also performed with the standard of care modality, transesophageal echocardiography (TEE) with both operators blinded to the opposing imaging modality. The presence of LAA thrombi requires cancellation of the clinical procedure. After a determination has been made by both operators regarding the presence or absence of thrombi will investigators be unblinded to the opposing imaging modality result. If intracardiac thrombi was detected, the procedure was cancelled according to standard clinical guidelines and practice. There is no follow-up data collected. Participants were followed during enrollment and the clinical ablation procedure which is an average of a 6 hour period.|Time of Clinical Procedure Only (Average 6 hours)|||participants|||Number
644318|NCT02213510|Secondary|Patient Incision Pain|Incision pain experienced by the patient was evaluated at 3 months post-procedure. This was evaluated on a scale of 0 (least pain) to 10 (worst pain).|3 months|||units on a scale||Standard Deviation|Mean
644319|NCT02213510|Secondary|Patient Incision Pain|At 2 week post-procedure, incision pain was evaluated on a scale 0 to 10 (worst pain).|2 weeks|||units on a scale||Standard Deviation|Mean
644320|NCT02213510|Secondary|Patient Incision Pain|At the discharge visit, patients evaluated their level of pain at the incision site based on a scale 1 (least pain) through 10 (worst pain).|1 day (discharge)|||units on a scale||Standard Deviation|Mean
644321|NCT02213510|Secondary|Patient Rating of Scar|"At 3 months post-procedure, patients were asked to rate their scar. Scale was measured from 0 (best scar) - 10 (worst scar)
Please note that only 18 patients were evaluated (of 19) in the Standard Suture Closure due to one patient withdrawing from the trial."|3 months|||units on a scale||Standard Deviation|Mean
644322|NCT02213510|Secondary|Patient Satisfaction With Scar|"Patient will complete questionnaires that includes assessments of the following:
Pain
Closure Method Comfort
Closure Method Satisfaction
Scar Satisfaction
Scar Satisfaction was measured on a scale from 1 (most satisfied) to 5 (least satisfied)
Please note that only 18 patients were evaluated (of 19) in the Standard Suture Closure due to one patient withdrawing from the trial."|3 months|||units on a scale||Standard Deviation|Mean
644323|NCT02213510|Secondary|Patient Comfort|At 2 weeks post-procedure, patient comfort was evaluated with a scale 1 (most favorable) to 5 (least favorable).|2 weeks|||units on a scale||Standard Deviation|Mean
644324|NCT02213510|Secondary|Surgeon Satisfaction With Scar|"At 3 months post-procedure, the surgeon evaluated their satisfaction on a scale from 1 to 5, 5 being the least favorable.
Please note that only 18 patients were evaluated (of 19) in the Standard Suture Closure due to one patient withdrawing from the trial."|3 months|||units on a scale||Standard Deviation|Mean
644325|NCT02213510|Secondary|Surgeon Evaluation Based on the Wound Evaluation Scale (WES)|"The surgeon will complete an assessment of the following:
Closure Method Satisfaction
Scar Satisfaction
Wound Healing as judged by Wound Evaluation Scale
Scale rated on 1 (least favorable) to 6 (most favorable)
Please note that only 18 patients were evaluated (of 19) in the Standard Suture Closure due to one patient withdrawing from the trial."|3 Months|||units on a scale||Standard Deviation|Mean
644326|NCT02213510|Secondary|Surgeon Wound Evaluation Scale (WES)|At 2 weeks post-procedure, the Wound Evaluation Scale was measured. The scale is based from 0 (representing normal skin) to 100 (representing a poor scar).|2 weeks|||units on a scale||Standard Deviation|Mean
644327|NCT02213510|Primary|Wound Healing as Determined by the CVAS (Cosmetic Visual Analogue Scale)|Based on photographs taken of scars taken at 3 months following CIED procedure. The CVAS scale is measured from 0mm (representing best scar) to 100 mm (representing worst scar).|3 Months|Please note that only 18 patients were evaluated (of 19) in the Standard Suture Closure due to one patient withdrawing from the trial.||mm||Standard Deviation|Mean
644328|NCT02213510|Primary|Overall Closure Time|Duration of time starting when suture needle (control) or Zip device touches the skin until final suture knot is cut or Zip device application is complete (e.g., top liner is removed.)|2 weeks|||seconds||Standard Deviation|Mean
644329|NCT02213250|Secondary|Number of Subjects With Thrombogenicity||From the subject provided informed consent through and including 28 calendar days after the last administration of the study drug.|The safety analysis population included All participants who received at least 1 dose of BeneFIX.||Participants|||Number
644330|NCT02213250|Secondary|Number of Participants With Allergic Reactions||From the subject provided informed consent through and including 28 calendar days after the last administration of the study drug.|The safety analysis population included All participants who received at least 1 dose of BeneFIX.||Participants|||Number
646406|NCT02146352|Secondary|Lumen Patency Outcome Measure|Lumen Patency: The stent lumen must be patent at 30 days and/or 60 days of implantation.|30 and/or 60 days post-procedure|Per Protocol||percentage of patients|||Number
644333|NCT02213250|Secondary|Number of Participants With Abnormal Clinical Laboratory Measurements (Without Regard to Baseline Abnormality)|Clinical laboratory analysis tests included hematology, serium chemistry, prothrombin time and urianalysis. Numbers of subjects with laboratory test abnormalities without regard to baseline abnormality were reported.|Baseline up to 96 hours post-dose (Day 5 or early termination)|The safety analysis population included All participants who received at least 1 dose of BeneFIX.||Participants|||Number
644334|NCT02213250|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAE), Serious Adverse Events (SAE), and Withdrawals Due to Adverse Events (AE)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAE is defined as newly occurring or worsening after first dose.|From the subject provided informed consent through and including 28 calendar days after the last administration of the study drug.|The safety analysis set was defined as all participants who received at least 1 dose of BeneFIX.||Particpants|||Number
644335|NCT02213250|Primary|Incremental Recovery|Incremental recovery: Increase in circulating increase in FIX activity for every IU of BeneFIX administered per kg of body weight.|Pre-dose, 0.25, 0.5 and 1 hour post-dose|The PK parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the PK parameters of primary interest. All participants were included in the PK analysis population.||(IU/dL)/(IU/Kg)||Geometric Coefficient of Variation|Geometric Mean
644336|NCT02213250|Primary|Systemic Clearance (CL)|CL is a quantitative measure of the rate at which a drug substance is removed from the body.|Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose|The PK parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the PK parameters of primary interest. All participants were included in the PK analysis population.||mL/hr/kg||Geometric Coefficient of Variation|Geometric Mean
644337|NCT02213250|Primary|Plasma Decay Half-Life (t½)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose|The PK parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the PK parameters of primary interest. All participants were included in the PK analysis population.||hours||Standard Deviation|Mean
644338|NCT02213250|Primary|Mean Residence Time (MRT)|AUMCinf/AUCinf, where AUMCinf is the area under the first moment curve from time 0 extrapolated to infinite time, calculated using the linear/log trapezoidal method.|Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose|The PK parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the PK parameters of primary interest. All participants were included in the PK analysis population.||hours||Geometric Coefficient of Variation|Geometric Mean
644339|NCT02213250|Primary|Terminal Phase Rate Constant (Kel)|Linear regression of the log linear concentration time curve. Only those data points judged to describe the terminal log linear decline were used in the regression.|Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose|The PK parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the PK parameters of primary interest. All participants were included in the PK analysis population.||1/hr||Geometric Coefficient of Variation|Geometric Mean
644340|NCT02213250|Primary|Volume of Distribution at Steady State (Vss)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vss is the apparent volume of distribution at steady-state.|Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose|The PK parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the PK parameters of primary interest. All participants were included in the PK analysis population.||milliliter/kilogram (mL/kg)||Geometric Coefficient of Variation|Geometric Mean
644341|NCT02213250|Primary|Time to Reach Cmax (Tmax)||Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose|The PK parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the PK parameters of primary interest. All participants were included in the PK analysis population.||hours||Full Range|Median
644342|NCT02213250|Primary|Area Under the Concentration Time Curve From Time 0 to Infinity (AUCinf)||Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose|The PK parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the PK parameters of primary interest. All participants were included in the PK analysis population.||IU*hr/ml||Geometric Coefficient of Variation|Geometric Mean
644343|NCT02213250|Primary|Area Under the Concentration Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast)||Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose|The PK parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the PK parameters of primary interest. All participants were included in the PK analysis population.||IU*hour/milliliter (IU*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
644344|NCT02213250|Primary|Maximum Observed Plasma Concentration (Cmax)||Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose|The pharmacokinetics (PK) parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the PK parameters of primary interest. All participants were included in the PK analysis population.||IU/milliliter (IU/mL)||Geometric Coefficient of Variation|Geometric Mean
644345|NCT02213198|Primary|Engagement in Treatment|Whether patient kept appointment post TCC|baseline throught study completion|All patients for whom survey (call data) were available post TCC discharge||Participants|||Count of Participants
644346|NCT02213198|Primary|Subjective Quality of Life|The Quality of Life Interview (QOLI; 91) is a 45-minute structured interview that assesses quality of life in the domains of family, social relations, leisure activities, finances, legal/safety issues, work/school, and health. It is one of the most psychometrically sound QoL instruments for use in mental illness. The subjective scale assesses quality of life from the perspective of the patient. Subjective QOL = Mean of items 1,3,8,9,11,13,16,18,20,21 . Scores range from 1-7. Higher scores indicate better quality of life|baseline through study completion|All patients with baseline and at least one follow up on QOL||units on a scale||Standard Deviation|Mean
648277|NCT02107014|Primary|Change in IL-10 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].|||pg/mL||95% Confidence Interval|Median
644347|NCT02213055|Primary|Number of Participants Free of Live Head Lice and Free of Viable Eggs|"A determination of head lice effectiveness, measured by number of subjects free of live lice and by number of subjects free of viable eggs, was calculated using two week post-treatment data as the primary study outcome. Measurements were calculated at Day 1 (day after first treatment) and Day 14.
At diagnosis, 55 subjects had viable eggs with three subjects meeting enrollment criteria for three or more live lice."|Day after first treatment and Day 14 of study|There were 58 evaluable subjects in the experimental (LiceMD) arm of the study.||Participants|||Number
644348|NCT02212977|Secondary|Closure Materials Cost|Per unit cost for suture and octylcyanoacrylate|Baseline|||dollars|||Number
644349|NCT02212977|Secondary|Closure Time|To compare closure time and associated costs between these two methods of skin closure.|Baseline|||minutes||Standard Deviation|Mean
644350|NCT02212977|Secondary|Healing-incision Cosmesis Score by Visual Analogue Scale|To compare resultant cosmesis with topic skin adhesive closure versus suture closure. Scale is 1-10 with 1 as the best possible outcome and 10 is the worst possible outcome.|3 months|Only participants who completed the Healing-incision cosmesis score by Visual Analogue Scale were included in the analysis.||units on a scale||Standard Deviation|Mean
644351|NCT02212977|Primary|Number of Participants With Complication of Infection|To compare complication rates, including wound dehiscence and infection rates between implantable port incisions closed with topical skin adhesive versus absorbable subcuticular sutures.|3 months|||participants|||Number
644352|NCT02212977|Primary|Number of Participants With Complication of Wound Dehiscence|To compare complication rates, including wound dehiscence and infection rates between implantable port incisions closed with topical skin adhesive versus absorbable subcuticular sutures.|3 months|||participants|||Number
644353|NCT02212834|Primary|Number of Breast Cancers Detected|Number of second breast cancers detected in the 12 months after surveillance mammogram or breast MRI|12 months post surveillance exam|||cancers detected|exams||Number
644354|NCT02212457|Secondary|Number of Subjects Reporting Any Serious AE (SAE)|The number of subjects reporting any SAE, possibly or probably related SAE(s), medically-attended AEs, AEs leading to premature withdrawal, AEs leading to death, AEs leading to hospitalization and AEs leading to dose reduction, interruption and delay in study vaccination during the entire study period is reported.|During the entire study period upto study completion, an average of 2 years|Analysis was done on all subjects in the Unsolicited Safety Set-all screened subjects who provided informed consent & provided demographic &/or other baseline screening measurements, regardless of the subject’s randomization & vaccination status, received a subject ID, received a study vaccination and have post-vaccination unsolicited AE records.||Subjects|||Number
644355|NCT02212457|Secondary|Number of Subjects Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity.|Number of subjects reporting any solicited local or systemic AEs and other indicators of reactogenicity from Day 1 (6 hours) to Day 7 after any meningococcal vaccination is reported.|At Day 1 (6 hours) to Day 7 after vaccination|Analysis was done on all subjects in the Solicited Safety Set-all screened subjects who provided informed consent & provided demographic &/ other baseline screening measurements,regardless of the subject’s randomization & vaccination status in the trial,received a subject ID,provided post-vaccination reactogenicity data & received study vaccination||Subjects|||Number
644356|NCT02212457|Secondary|Number of Subjects Reporting Unsolicited AEs After Any Vaccination|The number of subjects reporting unsolicited AEs and possibly or probably related unsolicited AEs is reported.|Day 1 through Day 30 after any vaccination|Analysis was done on subjects in the Unsolicited Safety Set -all screened subjects who provided informed consent & provided demographic &/or other baseline screening measurements, regardless of the subject’s randomization & vaccination status, received a subject ID, received a study vaccination & have either post-vaccination reactogenicity records.||Subjects|||Number
644357|NCT02212457|Secondary|Number of Subjects Reporting Any Unsolicited AEs|Number of subjects reporting any unsolicited AE within 30 minutes after each vaccination|Within 30 minutes after vaccination||11/2018||||
644358|NCT02212457|Secondary|Number of Subjects Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity.|Number of subjects reporting any solicited local or systemic AEs and other indicators of reactogenicity within 30 minutes after each vaccination.|Within 30 minutes after vaccination|Analysis was done on subjects in Solicited Safety Set - all screened subjects who provided informed consent & provided demographic &/or other baseline screening measurements, regardless of the subject’s randomization & vaccination status in the trial, received a subject ID,provided post-vaccination reactogenicity data & received a study vaccination||Subjects|||Number
644359|NCT02212457|Secondary|Percentages of Subjects With hSBA Titers ≥ LLQ for Serogroups C and Y, and for Three Serogroup B Test Strains.|The kinetic of immune response (at Months 0, 2, 3, 7 and 13) following different vaccination schedules as measured by the percentages of subjects with hSBA titers ≥ LLQ for serogroups C and Y, and for three serogroup B test strains (M14459, M01-0240364 and M07-0241084) is reported.|At Month 0, Month 2, Month 3, Month 7 and Month 13.||11/2018||||
644360|NCT02212457|Secondary|Percentages of Subjects With hSBA Titers ≥LLQ at Each Time Point Against Serogroups A, C, W and Y and Serogroup B Test Strains|The kinetic of immune response (at Months 0, 2, 3, 7 and 13) following different vaccination schedules as measured by the percentages of subjects with hSBA titers ≥LLQ against serogroups A, C, W and Y and serogroup B test strains, was described.|At Month 0, Month 2, Month 3, Month 7 and Month 13||11/2018||||
644361|NCT02212457|Secondary|Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains.|The kinetic of immune response (at Months 2, 3, 7 and 13) following different vaccination schedules as measured by the percentages of subjects with two-, three- and four-fold titer rise against serogroups A, C, W and Y and serogroup B test strains, is reported.|At Month 2, Month 3, Month 7 and Month 13||11/2018||||
644362|NCT02212457|Secondary|Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against Serogroups A, C, W and Y and Serogroup B Test Strains|The kinetic of immune response (at Months 0, 2, 3, 7 and 13) following different vaccination schedules as measured by the percentages of subjects with hSBA titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 against serogroups A, C, W and Y and serogroup B test strains, is reported.|At Month 0, Month 2, Month 3, Month 7 and Month 13.||11/2018||||
646407|NCT02146352|Secondary|Stent Retention Outcome Measure|Stent Retention: The stent must remain in place for up to 60 days|30 or 60 days post-procedure|Per Protocol Population||percentage of patients|||Number
644363|NCT02212457|Secondary|hSBA GMTs Against Serogroups A, C, W and Y and Serogroup B Test Strains at All the Relevant Time Points.|The kinetic of immune response (at Months 0, 2, 3, 7 and 13) following different vaccination schedules as measured by the hSBA GMTs against serogroups A,C, W and Y and serogroup B test strains is reported.|At Month 0, Month 2, Month 3, Month 7 and Month 13||11/2018||||
644364|NCT02212457|Secondary|Percentages of Subjects With hSBA Titers ≥ LLQ Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains.|The immunogenicity of MenABCWY vaccine, administered according to 0, 2 month schedule, was compared with those, administered according to 0, 1 month, 0, 6 month and 0, 11 month schedules, as measured by the percentages of subjects with hSBA titers ≥ LLQ against N. meningitidis serogroups A, C, W and Y and serogroup B test strains at 1 month after the second meningococcal vaccination.|At Month 2, Month 3, Month 7 and Month 12||11/2018||||
644365|NCT02212457|Secondary|Percentages of Subjects With hSBA Titers ≥ Lower Limit of Quantitation (LLQ) Against Serogroup B Test Strains.|The immunogenicity of MenABCWY vaccine, administered according to 0, 2, 6 month schedule, was compared with those, administered according to 0, 6 month schedule, as measured by the percentages of subjects with hSBA titers ≥ LLQ against serogroup B test strains at 1 month after the last meningococcal vaccination.|At baseline (Month 0) and 1 month after the last meningococcal vaccination (Month 3/Month 7)||11/2018||||
644366|NCT02212457|Secondary|Percentages of Subjects With hSBA Titers ≥ Lower Limit of Quantitation (LLQ) Against N. Meningitidis Serogroup B Test Strains.|The immunogenicity of the MenABCWY vaccine was compared to the immunogenicity of the Bexsero™ vaccine, administered according to 0, 2 month schedule, as measured by the percentages of subjects with hSBA titers ≥ Lower Limit of Quantitation (LLQ) against N. meningitidis serogroup B test strains at 1 month after the last meningococcal vaccination.|At Day 71||11/2018||||
644367|NCT02212457|Secondary|hSBA GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains|The immunogenicity of MenABCWY vaccine, administered according to 0, 2, 6 months schedule is compared with those administered according to 0, 6 months schedule, as measured by hSBA GMTs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains at 1 month after the last meningococcal vaccination.|At Month 7||11/2018||||
644368|NCT02212457|Secondary|Percentages of Subjects With hSBA Titers ≥ Lower Limit of Quantitation (LLQ) Against N. Meningitidis Serogroup B Test Strains.|"A sufficient immune response following Bexsero™ vaccine, administered according to 0, 2 month schedule, as measured by the percentage of subjects with hSBA titers ≥ Lower Limit of Quantitation (LLQ) against N. meningitidis serogroup B test strains at 1 month after the last meningococcal vaccination, was demonstrated. Criterion: the immune response will be considered sufficient if the lower limit of the two-sided 95% CI for the percentage of subjects with hSBA titers ≥ LLQ is greater than 75% for each of the four serogroup B test strains.
The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab."|At baseline (Month 0) and 1 month after the last meningococcal vaccination (Month 3)||11/2018||||
644369|NCT02212457|Secondary|hSBA GMTs Against Each of N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains|The immunogenicity of MenABCWY vaccine, administered according to 0, 2 months schedule, was compared with those, administered according to 0, 1 month, 0, 6 month and 0, 11 month schedules as measured by hSBA GMTs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains at 1 month after the second meningococcal vaccination.|At Month 0 (baseline), Month 2, Month 3, Month 7, and Month 13||11/2018||||
644370|NCT02212457|Secondary|Percentages of Subjects With hSBA Titers ≥ Lower Limit of Quantitation (LLQ) Against N. Meningitidis Serogroup B Test Strains|The immunogenicity of MenABCWY vaccine, administered according to 0, 2, 6 month schedule, was compared with those, administered according to 0, 2 month schedule, as measured by the percentages of subjects with hSBA titers ≥ LLQ against N. meningitidis serogroup B test strains at 1 month after the last meningococcal vaccination.|At baseline (Month 0) and 1 month after the last meningococcal vaccination (Month 3/Month 7)|Analysis was done on the FAS 1 month after the last meningococcal vaccination. Analysis for this outcome measure was carried out only on the subjects in the ABCWY_0_2 group and ABCWY_0_2_6 group in the FAS 1 month after the last meningococcal vaccination, at each visit.||Percentages of subjects||95% Confidence Interval|Number
644371|NCT02212457|Secondary|hSBA GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains.|"The immunogenicity of MenABCWY vaccine, administered according to 0, 2, 6 months schedule is compared with those administered according to 0, 2 months schedule, as measured by hSBA GMTs against N. meningitidis serogroup B test strains at 1 month after the last meningococcal vaccination.
The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab. This outcome measure was evaluated only in the ABCWY_ 0_2 and ABCWY_0_2_6 Groups.
The analysis was done on the Full analysis set (FAS) 1 month after the last meningococcal vaccination. 1 month post last meningococcal vaccination corresponds to Month 3 for ABCWY_0_2 Group and Month 7 for ABCWY_0_2_6 Group."|At baseline (Month 0) and 1 month after the last meningococcal vaccination (Month 3/Month 7)|Analysis was done on the FAS-1 month after the last meningococcal vaccination.All subjects in All Enrolled Set who received a study meningococcal vaccination & provided evaluable serum samples at pre- & at one month after the last meningococcal vaccination whose result is available for at least one A,C,W,or Y serogroup or serogroup B test strain.||Titers||95% Confidence Interval|Geometric Mean
644372|NCT02212457|Primary|Human Serum Bactericidal Assay (hSBA) Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup B Test Strains.|"The non-inferiority of the Meningococcal (groups A, C, W and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant (MenABCWY) vaccine to Meningococcal (group B) multicomponent recombinant adsorbed (Bexsero™) vaccine, administered according to 0, 2 month schedule, as measured by hSBA GMTs against N.meningitidis serogroup B test strains at 1 month after the last meningococcal vaccination, is reported.
The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab.
This outcome measure was evaluated only in the rMenB_0_2 and ABCWY_ 0_2 Groups."|At baseline (Month 0) and 1 month after the last meningococcal vaccination (Month 3)|Analysis was done on the Per Protocol Set (PPS)–Month 3, ie,subjects in All Enrolled Set who:received a study vaccination, provided evaluable serum samples at pre- & post-vaccination, with results available for at least 1 serogroup B test strain & who was not excluded due to protocol deviations or other reasons defined before unblinding or analysis||Titers||95% Confidence Interval|Geometric Mean
644373|NCT02212301|Primary|Time Controlled Visual Acuity|The Time Controlled Visual Acuity test is a proprietary test part of MG Vision Advanced Visual Performance Assessment. The test for distance vision is carried out at 4m under high contrast and dim luminance. The test is presented on a fast response 17” LCD screen (1280 by 1064). The test for intermediate vision is carried out at 64cm under high contrast dim luminance. The test was presented on a fast response 13.3” LCD screen (3200 by 1800). Visual acuity will be measured in a controlled environment using logMAR units.|8 hours post insertion|The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted for each lens at both near (40cm) and far distance (4m).||LogMAR||Standard Deviation|Mean
644374|NCT02212301|Primary|Tear Film Kinetics|The non-invasive tear film break-up-time (NIBUT) is the time elapsed (in seconds) between eye opening after a blink, and the appearance of the first dark spot within the tear film when observed with the wide diffuse light source of the Tearscope. This measurement is indicative of the tear film stability and the on eye wettability of contact lenses.|8 hour post insertion|The analysis population consists of subjects that completed all study visits without a major protocol deviation (per-protocol). One subjects was excluded from the analysis population due to a major protocol deviation.||Seconds||Standard Deviation|Mean
644375|NCT02212197|Secondary|Mean Prostate Specific Antigen (PSA) Concentration|The PD effects of leuprolide were assessed by measuring serum PSA concentrations during the trial. The following PD variable was analyzed: PSA (ng/mL) response to IMP. Blood samples for analyses of plasma PSA concentrations were collected at Screening and on Days 0 to 126.|Days 0-126|The Per-Protocol Set (PPS) consisted of all randomized participants in the safety population who had a complete PK profile. In the CAM2032 3.75 mg group 15 of the 19 randomized participants were included in the PPS.||ng/mL||Inter-Quartile Range|Median
644376|NCT02212197|Secondary|Profiles of Testesterone Concentration (ng/dL) Following Injections of the Investigational Medicinal Product (IMP)|The PD effects of leuprolide were assessed by measuring serum testosterone concentrations during the trial. The following PD variable was analyzed: The profiles of testosterone concentration (ng/dL) following injections of the IMP. Blood samples for analyses of serum testosterone concentrations were collected at Screening and on Days 0 to 126.|Days 0-126|The Per-Protocol Set (PPS) consisted of all randomized participants in the safety population who had a complete PK profile. In the CAM2032 3.75 mg group 15 of the 19 randomized participants were included in the PPS.||ng/dL||Inter-Quartile Range|Median
644377|NCT02212197|Secondary|Time (Days) to Testosterone Recovery After Dose 3|The pharmacodynamic (PD) effects of leuprolide were assessed by measuring serum testosterone during the trial. Time to testosterone recovery after last dose of the IMP. Blood samples for analyses of serum testosterone concentrations were collected at Screening and on Days 0 to 126.|Days 56-126|The Per-Protocol Set (PPS) consisted of all randomized participants in the safety population who had a complete PK profile. In the CAM2032 3.75 mg group 15 of the 19 randomized participants were included in the PPS.||days||Standard Deviation|Mean
644378|NCT02212197|Primary|Area Under the Serum Concentration-time Curve (AUC) Over the Dosing Interval (AUCtau) for Dose 1 and Dose 3|Blood samples for analysis of serum leuprolide concentrations were collected at pre-determined time points throughout the trial (with full PK profiles after Dose 1 and Dose 3). The PK parameter, AUCtau was derived for Doses 1 and 3 of the IMP.|Days 0-28 and Days 56-84 (0-672 hours after Doses 1 and 3)|The Per-Protocol Set (PPS) consisted of all randomized participants in the safety population who had a complete PK profile. In the CAM2032 3.75 mg group 15 of the 19 randomized participants were included in the PPS.||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
644379|NCT02212197|Primary|Apparent Terminal Half-life (t½) for Dose 1 and Dose 3|Blood samples for analysis of serum leuprolide concentrations were collected at pre-determined time points throughout the trial (with full PK profiles after Dose 1 and Dose 3). The PK parameter, t1/2 was derived for Doses 1 and 3 of the IMP.|Days 0-28 and Days 56-84|The Per-Protocol Set (PPS) consisted of all randomized participants in the safety population who had a complete PK profile. In the CAM2032 3.75 mg group 15 of the 19 randomized participants were included in the PPS.||hour||Standard Deviation|Mean
644380|NCT02212197|Primary|Observed Maximum Serum Leuprolide Concentration (Cmax) for Dose 1 and Dose 3|Blood samples for analysis of serum leuprolide concentrations were collected at pre-determined time points throughout the trial (with full PK profiles after Dose 1 and Dose 3). The PK parameter, Cmax was derived for Doses 1 and 3 of the investigational medicinal product (IMP).|84 days|The Per-Protocol Set (PPS) consisted of all randomized participants in the safety population who had a complete PK profile. In the CAM2032 3.75 mg group 15 of the 19 randomized participants were included in the PPS.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
644381|NCT02212106|Secondary|The Incidence of Serious Adverse Events (SAEs) Occurring up to 7 Days After the Last Administration of CSL TIV or the Comparator Influenza Virus Vaccine.|The number of subjects experiencing at least one SAE.|7 days after each administration of vaccine.|All randomized subjects who received at least one scheduled vaccination and had post-vaccination followup safety data available.||Number of subjects|||Number
644382|NCT02212106|Secondary|The Frequency and Intensity of Unsolicited AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.|The overall frequency and intensity of unsolicited Adverse Events (AEs) occurring during the 7 days after each administration of CSL TIV or the comparator influenza virus vaccine. Percentage of subjects who experienced each event are based on the number of subjects in the Safety Population group. Excludes subjects with missing intensity information for the whole 7 days. If a subject has multiple events of the same intensity or causality, then they are counted only once in that intensity or causality. However, subjects can be counted more than once overall.|7 days after each administration of vaccine.|All randomized subjects who received at least one scheduled vaccination and had post-vaccination followup safety data available.||Percentage of subjects|||Number
644436|NCT02209506|Secondary|Rac AUC(0-96): Accumulation Ratio of AUC(0-96) for MLN3126 and Its Metabolite|M-I is the inactive metabolite of MLN3126.|Days 1 and 15: pre-dose and at multiple timepoints (up to 96 hours) post-dose|The PK analysis set included all participants who received the study drug and had at least 1 measurable plasma concentration for either MLN3126 or its M-I metabolite.||ratio||Standard Deviation|Mean
644438|NCT02209506|Secondary|Cav: Average Plasma Concentration for MLN3126 and Its Metabolite on Day 1|M-I is the inactive metabolite of MLN3126.|Day 1: pre-dose and at multiple timepoints (up to 96 hours) post-dose|The PK analysis set included all participants who received the study drug and had at least 1 measurable plasma concentration for either MLN3126 or its M-I metabolite.||ng/mL||Standard Deviation|Mean
644383|NCT02212106|Secondary|The Frequency and Intensity of Solicited Systemic AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.|The overall frequency and intensity of solicited systemic Adverse Events (AEs) occurring during the 7 days after each administration of CSL TIV or the comparator influenza virus vaccine. Percentage of subjects who experienced each event are based on the number of subjects in the Safety Population group. Excludes subjects with missing intensity information for the whole 7 days. Percentages for intensity are based on the number of subjects with non-missing intensity data. Only the maximum intensity experienced between Day 1 and Day 7 are presented for each subject.|7 days after each administration of vaccine.|All randomized subjects who received at least one scheduled vaccination and had post-vaccination followup safety data available.||Percentage of subjects|||Number
644384|NCT02212106|Secondary|The Frequency and Intensity of Solicited Local Adverse Events (AEs) Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.|The overall frequency and intensity of solicited local Adverse Events (AEs) occurring during the 7 days after each administration of bioCSL TIV or the comparator influenza virus vaccine. Percentage of subjects who experienced each event are based on the number of subjects in the Safety Population group. Excludes subjects with missing intensity information for the whole 7 days. Percentages for intensity are based on the number of subjects with non-missing intensity data. Only the maximum intensity experienced between Day 1 and Day 7 are presented for each subject.|7 days after each administration of vaccine.|All randomized subjects who received at least one scheduled vaccination and had post-vaccination followup safety data available.||Percentage of subjects|||Number
644385|NCT02212106|Secondary|The Frequency and Intensity of Vaccine-related Fever Events Occurring During the 7 Days After Each Administration of CSL TIV Vaccine or Comparator Influenza Virus Vaccine.|Percentage of subjects with a related fever event (overall) by study vaccine group based on the number of subjects contributing any follow up safety information for at least one data value of an individual sign/symptom. Excludes subjects with missing intensity information for the whole 7 days. Mild fever: ≥ 100.4 to < 101.3º F (≥ 38.0 to < 38.5º C). Moderate fever: ≥ 101.3 to < 102.2º F (≥ 38.5 to < 39.0º C). Severe fever: ≥ 102.2º F (≥ 39.0º C).|7 days after each administration of vaccine.|All randomized subjects who received at least one scheduled vaccination and had post-vaccination followup safety data available.||Percentage of subjects|||Number
644386|NCT02212106|Secondary|The Frequency and Intensity of Fever Events Occurring During the 7 Days After Each Administration of the Comparator Influenza Virus Vaccine.|The overall percentage of subjects reporting at least one fever event after administration of the comparator influenza virus vaccine. A fever event was defined as an oral temperature ≥ 38°C (≥ 100.4°F). The intensity was calculated as follows: • Mild: ≥ 100.4 to < 101.3°F (≥ 38.0 to < 38.5°C) • Moderate: ≥ 101.3 to < 102.2°F (≥ 38.5 to < 39.0°C) • Severe: ≥ 102.2°F (≥ 39.0°C).|7 days after each administration of vaccine.|All randomized subjects who received at least one scheduled vaccination and had post-vaccination follow-up safety data available.||Percentage of subjects|||Number
644387|NCT02212106|Primary|The Frequency and Intensity of Fever Events Occurring During the 7 Days After Each Administration of CSL TIV Vaccine.|The overall percentage of subjects reporting at least one fever event after administration of bioCSL TIV. A fever event was defined as an oral temperature ≥ 38°C (≥ 100.4°F). The intensity was calculated as follows: • Mild: ≥ 100.4 to < 101.3°F (≥ 38.0 to < 38.5°C) • Moderate: ≥ 101.3 to < 102.2°F (≥ 38.5 to < 39.0°C) • Severe: ≥ 102.2°F (≥ 39.0°C)|7 days after each administration of vaccine.|All randomized subjects who received at least one scheduled vaccination and had post-vaccination follow-up safety data available.||Percentage of subjects|||Number
644388|NCT02212028|Secondary|Platelet Reactivity Index (PRI)|The secondary end-point of the study is the comparison in platelet reactivity expressed as PRI determined by whole blood vasodilator-stimulated phosphoprotein (VASP) between prasugrel 60 mg and crushed prasugrel 60 mg at 2 hours after LD administration|2 hrs|The primary population was defined as patients who received the randomized treatment and had a valid primary end point value (PRU at 2 hours) and was considered for analysis of all endpoints.||PRI||95% Confidence Interval|Least Squares Mean
644389|NCT02212028|Primary|P2Y12 Reaction Units (PRU)|The primary end-point of the study is the comparison in platelet reactivity expressed as PRU determined by VerifyNow P2Y12 between prasugrel 60 mg and crushed prasugrel 60 mg at 2 hours after LD administration|2 hrs|The primary population was defined as patients who received the randomized treatment and had a valid primary end point value (PRU at 2 hours) and was considered for analysis of all endpoints.||PRU||95% Confidence Interval|Least Squares Mean
644390|NCT02210208|Primary|Healing|Adequate take of skin graft (defined as at least 95% adherent and healed as assessed by clinical investigator)|14 days|Per protocol||Participants|||Count of Participants
644391|NCT02210195|Primary|Change From Week 0 in Drinking Quantity and Frequency Using Drinks Per Week at Week 8|Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. Change = (Week 8 - Week 0). More negative values indicate less use of alcohol.|Week 0 and Week 8|||drinks/week||Standard Deviation|Mean
644392|NCT02210195|Primary|Change From Week 0 in Cannabis Use Using Urinary CN-THCCOOH Levels at Week 8|Urinary THC/Cr ratio, also known as CN-THCCOOH (creatinine normalized tetrahydrocannabinol carboxylic acid), is a highly sensitive and specific quantitative analytic procedure to determine current marijuana metabolite levels in the urine as well as new marijuana use or abstinence. Gas chromatography mass spectrometric levels of 11-nor-9-carboxy-9-THC (THC-COOH), the primary marijuana metabolite, are normalized to the urine creatinine (CN) concentration to reduce the variability of drug measurement attributable to urine dilution. Negative values indicate decreased use. Change = (Week 8 value - Week 0 value).|Week 0 and Week 8|||ng/mg||Standard Deviation|Mean
644470|NCT02209181|Secondary|Pain Relief (PAR) Scores at 2 Hours Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|2 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
644437|NCT02209506|Secondary|Cavss: Average Plasma Concentration for MLN3126 and Its Metabolite at Steady State on Day 15|M-I is the inactive metabolite of MLN3126.|Day 15: pre-dose and at multiple timepoints (up to 96 hours) post-dose|The PK analysis set included all participants who received the study drug and had at least 1 measurable plasma concentration for either MLN3126 or its M-I metabolite.||ng/mL||Standard Deviation|Mean
644417|NCT02210052|Primary|Number of Procedures in Which Temperature of Screws Increased|The study will measure for increased temperature in pedicle screws adjacent to lumbar facet joints during radiofrequency neurotomy (RFN). Temperatures will be recorded by placing a thermistor probe on the surface of the adjacent hardware.|2 hours|There were 6 participants, but some participants had more than 1 procedure. There were a total of 10 procedures analyzed.||procedures|Procedures||Number
644418|NCT02209766|Secondary|AUC(0-tau) in Plasma Baseline-adjusted Total Eicosapentaenoic Acid (EPA), Single Dose||Day1-3, 4, 7, 11, 14, 17-18 and 25|||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
644419|NCT02209766|Secondary|AUC(0-tau) in Plasma Baseline-adjusted Total Docosahexaenoic Acid (DHA), Single Dose||Day1-3, 4, 7, 11, 14, 17-18 and 25|||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
644420|NCT02209766|Secondary|AUC(0-tau) in Plasma Baseline-adjusted Total EPA, Multiple Dose||Day1-3, 4, 7, 11, 14, 17-18 and 25|||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
644421|NCT02209766|Secondary|AUC(0-tau) in Plasma Baseline-adjusted Total DHA, Multiple Dose||Day1-3, 4, 7, 11, 14, 17-18 and 25|||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
644422|NCT02209766|Primary|Number of Patients With Treatment-emergent Adverse Events (TEAEs), by Treatment (Safety Analysis Set)|Number of patients with treatment-emergent adverse events (TEAEs), by treatment (Safety Analysis Set)|from first dosing (Day1) until follow-up (Day25)|||subjects|||Number
644423|NCT02209766|Secondary|Tmax in Plasma Baseline-adjusted Total DHA, Multiple Dose||Day1-3, 4, 7, 11, 14, 17-18 and 25|||h||Full Range|Median
644424|NCT02209766|Secondary|Cmax in Plasma Baseline-adjusted Total DHA, Multiple Dose||Day1-3, 4, 7, 11, 14, 17-18 and 25|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
644425|NCT02209766|Secondary|Tmax in Plasma Baseline-adjusted Total EPA, Multiple Dose||Day1-3, 4, 7, 11, 14, 17-18 and 25|||h||Full Range|Median
644426|NCT02209766|Secondary|Cmax in Plasma Baseline-adjusted Total EPA, Multiple Dose||Day1-3, 4, 7, 11, 14, 17-18 and 25|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
644427|NCT02209766|Secondary|Tmax in Plasma Baseline-adjusted Total DHA, Single Dose||Day1-3, 4, 7, 11, 14, 17-18 and 25|||h||Full Range|Median
644428|NCT02209766|Secondary|Cmax in Plasma Baseline-adjusted Total Docosahexaenoic Acid (DHA), Single Dose||Day1-3, 4, 7, 11, 14, 17-18 and 25|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
644429|NCT02209766|Secondary|Tmax in Plasma Baseline-adjusted Total EPA, Single Dose||Day1-3, 4, 7, 11, 14, 17-18 and 25|||h||Full Range|Median
644430|NCT02209766|Secondary|Cmax in Plasma Baseline-adjusted Total Eicosapentaenoic Acid (EPA), Single Dose||Day1-3, 4, 7, 11, 14, 17-18 and 25|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
644431|NCT02209506|Secondary|CLr: Renal Clearance of MLN3126 and Its Metabolite|CLr is the volume of plasma from which the drug is completely removed by the kidney in a given amount of time, calculated as the amount of drug excreted in the urine divided by the area under the plasma concentration-time curve, expressed in liter per hour (L/hr). M-I is the inactive metabolite of MLN3126.|Days 1 and 15: pre-dose and at multiple timepoints (up to 96 hours) post-dose|Data is not reported because the study was terminated early at Cohorts 2A and 1B, yielding limited data for only 2 dose levels of MLN3126 in non-Japanese participants and one dose level in Japanese participants. Therefore the analyses to determine urine PK parameters was not performed.|||||
644432|NCT02209506|Secondary|Fe (0-4): Fraction of Dose of MLN3126 and Its Metabolite Excreted Unchanged in Urine From 0 to 4 Hours Post Dose|M-I is the inactive metabolite of MLN3126.|Days 1 and 15: pre-dose and at multiple timepoints (up to 4 hours) post-dose|Data is not reported because the study was terminated early at Cohorts 2A and 1B, yielding limited data for only 2 dose levels of MLN3126 in non-Japanese participants and one dose level in Japanese participants. Therefore the analyses to determine urine PK parameters was not performed.|||||
644433|NCT02209506|Secondary|Ae (0-4): Amount of MLN3126 and Its Metabolite Excreted in Urine From 0 to 4 Hours Post Dose|M-I is the inactive metabolite of MLN3126.|Days 1 and 15: pre-dose and at multiple timepoints (up to 4 hours) post-dose|Data is not reported because the study was terminated early at Cohorts 2A and 1B, yielding limited data for only 2 dose levels of MLN3126 in non-Japanese participants and one dose level in Japanese participants. Therefore the analyses to determine urine PK parameters was not performed.|||||
644434|NCT02209506|Secondary|Ratio of AUC(0-tau): Ratio of Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Between MLN3126 and Its Metabolite|M-I is the inactive metabolite of MLN3126.|Days 1 and 15: pre-dose and at multiple timepoints (up to 96 hours) post-dose|The PK analysis set included all participants who received the study drug and had at least 1 measurable plasma concentration for either MLN3126 or its M-I metabolite.||ratio||Standard Deviation|Mean
644435|NCT02209506|Secondary|Cmax Ratio: Ratio of Maximum Plasma Concentration Between MLN3126 and Its Metabolite|M-I is the inactive metabolite of MLN3126.|Days 1 and 15: pre-dose and at multiple timepoints (up to 96 hours) post-dose|The PK analysis set included all participants who received the study drug and had at least 1 measurable plasma concentration for either MLN3126 or its M-I metabolite.||ratio||Standard Deviation|Mean
644439|NCT02209506|Secondary|Terminal Phase Elimination Half-life (T1/2) for MLN3126 and Its Metabolite|M-I is the inactive metabolite of MLN3126.|Days 1 and 15: pre-dose and at multiple timepoints (up to 96 hours) post-dose|The PK analysis set included all participants who received the study drug and had at least 1 measurable plasma concentration for either MLN3126 or its M-I metabolite.||hours||Standard Deviation|Mean
644440|NCT02209506|Secondary|CL/F: Apparent Oral Clearance of MLN3126 and Its Metabolite After Multiple Dosing (at Steady State)|M-I is the inactive metabolite of MLN3126.|Day 1: predose and at multiple timepoints (up to 96 hours) post-dose|The PK analysis set included all participants who received the study drug and had at least 1 measurable plasma concentration for either MLN3126 or its M-I metabolite.||liter per hour (L/hr)||Standard Deviation|Mean
644441|NCT02209506|Secondary|AUC (0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for MLN3126 and Its Metabolite|M-I is the inactive metabolite of MLN3126.|Days 1 and 15: predose and at multiple timepoints (up to 96 hours) post-dose|The PK analysis set included all participants who received the study drug and had at least 1 measurable plasma concentration for either MLN3126 or its M-I metabolite.||ng*hr/mL||Standard Deviation|Mean
644442|NCT02209506|Secondary|AUC(0-96): Area Under the Plasma Concentration-time Curve From Time 0 to 96 Hours Post Dose for MLN3126 and Its Metabolite|M-I is the inactive metabolite of MLN3126.|Days 1 and 15: pre-dose and at multiple timepoints (up to 96 hours) post-dose|The PK analysis set included all participants who received the study drug and had at least 1 measurable plasma concentration for either MLN3126 or its M-I metabolite.||ng*hr/mL||Standard Deviation|Mean
644443|NCT02209506|Secondary|AUC (0-last): Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for MLN3126 and Its Metabolite|M-I is the inactive metabolite of MLN3126.|Days 1 and 15: pre-dose and at multiple timepoints (up to 96 hours) post-dose|The PK analysis set included all participants who received the study drug and had at least 1 measurable plasma concentration for either MLN3126 or its M-I metabolite.||ng*hr/mL||Standard Deviation|Mean
644444|NCT02209506|Secondary|AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau for MLN3126 and Its Metabolite|M-I is the inactive metabolite of MLN3126.|Days 1 and 15: pre-dose and at multiple timepoints (up to 96 hours) post-dose|The PK analysis set included all participants who received the study drug and had at least 1 measurable plasma concentration for either MLN3126 or its M-I metabolite.||nanogram*hour per milliliter (ng*hr/mL||Standard Deviation|Mean
644445|NCT02209506|Secondary|Tmax- Time to Reach the Cmax for MLN3126 and Its Metabolite|M-I is the inactive metabolite of MLN3126.|Days 1 and 15: pre-dose and at multiple timepoints (up to 96 hours) post-dose|The PK analysis set included all participants who received the study drug and had at least 1 measurable plasma concentration for either MLN3126 or its M-I metabolite.||hours||Full Range|Median
644446|NCT02209506|Secondary|Cmax: Maximum Plasma Concentration for MLN3126 and Its Metabolite|M-I is the inactive metabolite of MLN3126.|Days 1 and 15: pre-dose and at multiple timepoints (up to 96 hours) post-dose|The pharmacokinetic (PK) analysis set included all participants who received the study drug and had at least 1 measurable plasma concentration for either MLN3126 or its M-I metabolite.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
644447|NCT02209506|Primary|Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose|The percentage of participants who meet markedly abnormal criteria designated by Takeda Global Research and Development Center, Inc. (TGRD). Criteria for markedly abnormal vital signs included body temperature, systolic blood pressure, diastolic blood pressure and pulse rate.|Baseline up to 7 days after last dose of study drug (Day 22)|Safety analysis set included all participants who received at least 1 dose of study drug.||percentage of participants|||Number
644448|NCT02209506|Primary|Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose|The percentage of participants with any markedly abnormal, according to Takeda criteria, standard safety laboratory values, including hematology, serum chemistry, and urinalysis, during the treatment period.|Baseline up to 7 days after last dose of study drug (Day 22)|Safety analysis set included all participants who received at least 1 dose of study drug.||percentage of participants|||Number
644449|NCT02209506|Primary|Percentage of Participants Who Meet the Markedly Abnormal Criteria for Electrocardiogram Measurements at Least Once Post Dose|A standard 12-lead ECG was performed. The percentage of participants with markedly abnormal electrocardiogram (ECG) findings during the study.|Baseline up to 7 days after last dose of study drug (Day 22)|Safety analysis set included all participants who received at least 1 dose of study drug.||percentage of participants|||Number
644450|NCT02209506|Primary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)|A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.|Baseline up to 7 days after last dose of study drug (Day 22)|Safety analysis set included all participants who received at least 1 dose of study drug.||participants|||Number
644451|NCT02209454|Secondary|t1/2|AUC(0-∞) will be analysed similarly to AUC(0-t) and Cmax. Time to achieve maximum plasma concentration (tmax) and t1/2 will be summarized descriptively.|Up to 24h post-dose (pre-dose, T+5’, T+10’, T+15’, T+20’, T+30’, T+40’, T+50’, T+1h, T+1.25h, T+1.5h, T+2h, T+3h, T+3.5h, T+4h, T+5h, T+6h, T+8h, T+12h and T+24h post-dose).|Analyses of the primary PK variables were conducted on all randomised subjects who received at least one dose of DKP.TRIS (PK population) and on all subjects in the PK population who did not experience major protocol violations (PP population).||h||95% Confidence Interval|Geometric Mean
644452|NCT02209454|Secondary|Tmax|AUC(0-∞) will be analysed similarly to AUC(0-t) and Cmax. Time to achieve maximum plasma concentration (tmax).|Up to 24h post-dose (pre-dose, T+5’, T+10’, T+15’, T+20’, T+30’, T+40’, T+50’, T+1h, T+1.25h, T+1.5h, T+2h, T+3h, T+3.5h, T+4h, T+5h, T+6h, T+8h, T+12h and T+24h post-dose).|Analyses of the primary PK variables were conducted on all randomised subjects who received at least one dose of DKP.TRIS (PK population) and on all subjects in the PK population who did not experience major protocol violations (PP population).||h||Full Range|Median
644471|NCT02209181|Secondary|Pain Relief (PAR) Scores at 1.5 Hours Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|1.5 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
644504|NCT02208310|Secondary|Change in C-reactive Protein|Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here. The delta between first (baseline) and last CRP (Day 180) is reported here.|Day 180|||mg/dL|||Number
644453|NCT02209454|Primary|AUC(0-t)|The absence of any difference in the rate and extent of absorption will be demonstrated if the 90% CI for the geometric mean ratio between Test and Reference formulations is within the range 80.00% - 125.00% for AUC(0-t).|Up to 24h post-dose (pre-dose, T+5’, T+10’, T+15’, T+20’, T+30’, T+40’, T+50’, T+1h, T+1.25h, T+1.5h, T+2h, T+3h, T+3.5h, T+4h, T+5h, T+6h, T+8h, T+12h and T+24h post-dose).|Analyses of the primary PK variables were conducted on all randomised subjects who received at least one dose of DKP.TRIS (PK population) and on all subjects in the PK population who did not experience major protocol violations (PP population).||h*ng/mL||95% Confidence Interval|Geometric Mean
644454|NCT02209454|Secondary|AUC(0-∞)|AUC(0-∞) will be analysed similarly to AUC(0-t) and Cmax. Time to achieve maximum plasma concentration (tmax) and t1/2 will be summarized descriptively.|Up to 24h post-dose (pre-dose, T+5’, T+10’, T+15’, T+20’, T+30’, T+40’, T+50’, T+1h, T+1.25h, T+1.5h, T+2h, T+3h, T+3.5h, T+4h, T+5h, T+6h, T+8h, T+12h and T+24h post-dose).|Analyses of the primary PK variables were conducted on all randomised subjects who received at least one dose of DKP.TRIS (PK population) and on all subjects in the PK population who did not experience major protocol violations (PP population).||h*ng/mL||95% Confidence Interval|Geometric Mean
644455|NCT02209454|Primary|Cmax|The absence of any difference in the rate and extent of absorption will be demonstrated if the 90% CI for the geometric mean ratio between Test and Reference formulations is within the range 80.00% - 133.00% for Cmax.|Up to 24h post-dose (pre-dose, T+5’, T+10’, T+15’, T+20’, T+30’, T+40’, T+50’, T+1h, T+1.25h, T+1.5h, T+2h, T+3h, T+3.5h, T+4h, T+5h, T+6h, T+8h, T+12h and T+24h post-dose).|Analyses of the primary PK variables were conducted on all randomised subjects who received at least one dose of DKP.TRIS (PK population) and on all subjects in the PK population who did not experience major protocol violations (PP population).||ng/mL||95% Confidence Interval|Geometric Mean
644456|NCT02209181|Secondary|Subject Global Evaluation|How the subject would rate the study medication as a pain-reliever on a scale of 0-4 (where 0=poor and 4=excellent).|Completed at hour 12 or at time of the first rescue medication (hours post dose).|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||percentage of participants|||Number
644457|NCT02209181|Secondary|Duration of Pain Relief After Dosing (Time to Rescue Medication)|Time (minutes) to rescue medication was measured as the elapsed time from when the investigational product was given until the time rescue medication was given.|Completed at time of the first rescue medication (hours post dose), estimated up through Day 2|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||minutes||95% Confidence Interval|Median
644458|NCT02209181|Secondary|Pain Relief (PAR) Scores at 24 Hours Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|24 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
644459|NCT02209181|Secondary|Pain Relief (PAR) Scores at 16 Hours Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|16 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
644460|NCT02209181|Secondary|Pain Relief (PAR) Scores at 12 Hours Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|12 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
644461|NCT02209181|Secondary|Pain Relief (PAR) Scores at 11 Hours Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|11 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
644462|NCT02209181|Secondary|Pain Relief (PAR) Scores at 10 Hours Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|10 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
644463|NCT02209181|Secondary|Pain Relief (PAR) Scores at 9 Hours Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|9 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
644464|NCT02209181|Secondary|Pain Relief (PAR) Scores at 8 Hours Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|8 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
644465|NCT02209181|Secondary|Pain Relief (PAR) Scores at 7 Hours Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|7 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
644466|NCT02209181|Secondary|Pain Relief (PAR) Scores at 6 Hours Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|6 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
644467|NCT02209181|Secondary|Pain Relief (PAR) Scores at 5 Hours Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|5 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
644468|NCT02209181|Secondary|Pain Relief (PAR) Scores at 4 Hours Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|4 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
644469|NCT02209181|Secondary|Pain Relief (PAR) Scores at 3 Hours Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|3 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
646408|NCT02146352|Primary|Safety/Adverse Event Outcome Measure 1|Freedom from access site-related bleeding requiring transfusion|Index procedure through 1-week post-stent removal|Entire patient cohort||percentage of patients|||Number
644472|NCT02209181|Secondary|Pain Relief (PAR) Scores at 1 Hour Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|1 hour post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
644473|NCT02209181|Secondary|Pain Relief (PAR) Scores at 45 Minutes Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|45 minutes post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
644474|NCT02209181|Secondary|Pain Relief (PAR) Scores at 30 Minutes Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|30 minutes post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
644475|NCT02209181|Secondary|Pain Relief (PAR) Scores at 15 Minutes Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|15 minutes post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
644476|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 24 Hours Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 24 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
644477|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 16 Hours Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 16 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
644478|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 12 Hours Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 12 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
644479|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 11 Hours Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 11 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
644480|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 10 Hours Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 10 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
644481|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 9 Hours Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 9 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
644482|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 8 Hours Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 8 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
644483|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 7 Hours Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 7 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
644484|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 6 Hours Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 6 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
644485|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 5 Hours Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 5 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
644486|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 4 Hours Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 4 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
644487|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 3 Hours Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 3 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
644488|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 2 Hours Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 2 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
644489|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 1.5 Hours Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 1.5 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
644490|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 1 Hour Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 1 hour post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
644491|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 45 Minutes Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 45 minutes post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
644492|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 30 Minutes Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 30 minutes post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
644493|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 15 Minutes Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 15 minutes post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
644494|NCT02209181|Primary|Analgesic Efficacy From 0 to 6 Hours After the Dose Using the Time-weighted Sum of Pain Intensity Difference (SPID 0-6)|Time-weighted sum of pain intensity difference by first multiplying each pain intensity difference (PID) score by the time from the previous time point, and adding them together for each scheduled time point within 0-6 hours. Time points included 15 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours. The minimum SPID 0-6 was -30 and the maximum SPID 0-6 was 60, where higher is better. Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain).|6 Hours|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
644495|NCT02209064|Other Pre-specified|Number of Patients in Whom Pericardial Access Was Achieved With the EpiAccess System|Number of patients in whom the EpiAccess system was equivalently able to access the pericardial space, compared with standard of care minimally invasive access techniques,documented by using intra procedure or post procedure clinician survey|Access through end of procedure|||participants|||Number
644496|NCT02209064|Secondary|Percentage of Participants With a Pericardial Effusion of >80ml|Secondary endpoint will measure whether or not there was a pericardial effusion greater than 80ml.|Access through discharge/approximately 4 days|||percentage of participants|||Number
644497|NCT02209064|Secondary|Percentage of Participants in Whom Equivalent or Better Access Was Achieved With EpiAccess System|EpiAccess will provide equivalent or better access (defined as guidewire entry into the pericardial space) as compared to access with standard of care minimally invasive, subxiphoid access techniques.|access through procedure completion|||percentage of patients|||Number
644498|NCT02209064|Primary|Percentage of Participants in Whom Pericardial Access Was Achieved With the EpiAccess System|EpiAccess device shall be used to access the pericardial space with measurements tracked noting if access was achieved. The percentage of patients in whom pericardial access was successful will be reported.|Through discharge / approx 4 days|Percentage of patients in whom epicardial access was successful using the EpiAccess system. Successful access is defined as the ability to introduce a guide wire into the epicardial space.||percentage of patients|||Number
644499|NCT02208310|Secondary|Participants With at Least One Crohn's Related Emergency Department (ED) Visit|Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here. No CD-related ED visits occurred in the 1 subject|Day 180|||participants|||Number
644500|NCT02208310|Secondary|Change in Fatigue Measurements|"Change in FACIT-F scale over the year. Scale is 0-160 with 0 being no fatigue and 160 being extreme fatigue. A positive change indicates worsening in symptoms and a negative change indicates an improvement.
Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here."|Day 180|||units on a scale|||Number
644501|NCT02208310|Secondary|Quality of Life Measure Changes|"change in quality of life measures based on Inflammatory bowel disease questionnaire (IBD-Q).
Scale from 0 to 224 with 0 being the poorest quality of life and 224 being the highest quality of life. A positive change indicates improvement while a negative change indicates worsening.
Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here."|Day 180|||units on a scale|||Number
644502|NCT02208310|Secondary|Percent With Escalation of Therapy|Patients who had to have a change in therapy Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here.|Day 180|||Participants|||Count of Participants
644503|NCT02208310|Secondary|Changes in Fecal Calprotectin|Originally planned to collect at Day 180 and Day 360. Results were not collected on any subjects, as the one participant did not provide a stool sample.|1 year|Results were not collected on any subjects|||||
648278|NCT02107014|Primary|Change in IL-9 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].|||pg/mL||95% Confidence Interval|Median
644505|NCT02208310|Secondary|Change in Modified Harvey-Bradshaw Index (HBI Without Examination)|"modified Harvey-Bradshaw is a disease assessment scale. 0 is the lowest score and would be considered remission. Scale ranges to over 16 (upper limit is defined by the number of bowel movements in the prior day) with numbers over 16 being severe disease. A positive change (such as that indicated below) therefore references slightly worsening disease while a negative change references improving disease.
Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here. 1 subject had an increase of 1 unit on the modified HBI."|Day 180|||units on a scale (0-16)|||Number
644506|NCT02208310|Secondary|Crohn's Related Surgeries (Dichotomous 0/1 Per Subject)|Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here. No CD-related surgeries occurred in the 1 subject|Day 180|||CD-related surgery occurred|||Number
644507|NCT02208310|Secondary|Steroid Prescription Given (Dichotomous 0/1)|Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here. No steroid prescriptions occurred|Day 180|||Steroid prescription occurred|||Number
644508|NCT02208310|Secondary|Crohn's Related Hospitalizations|Dichotomous (0/1) endpoint for each subject, depending on whether a CD-related hospitalization occurred. Relatedness to Crohn's disease as judged by the DSMB. Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here.|Day 180|||CD-related hospitalization occurred|||Number
644509|NCT02208310|Primary|Incidence of Nephrolithiasis|Incidence of nephrolithiasis associated with hypercalcemia (>10.8mg/dl) documented by imaging Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here.|Day 180|||Participants|||Count of Participants
644510|NCT02208310|Primary|Hypercalcemia|Hypercalcemia is presented as number of participants with Calcium >10.8 mg/dl Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here.|Day 180|||Participants|||Count of Participants
644511|NCT02208310|Primary|Composite Endpoint: Number of Participants With (Any of) a CD-related Hospitalization, CD-related Surgery, CD-related ER Visits and Steroid Prescriptions|"Composite endpoint of (any of) Crohn's disease(CD)-related hospitalizations, CD-related surgeries, CD-related ER visits, or steroid prescriptions.
Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here."|Day 180|||participants|||Number
644512|NCT02207907|Secondary|Plaque Control (Overall and Interproximal Dental Plaque Scores) Using Turesky Modification of Quigley &Amp; Hein Plaque Index at 6, 12 and 24 Weeks.|The dental examiner used the Turesky Modification of the Quigley Hein Index to assess plaque on all gradable teeth. The plaque was first disclosed using a dye solution. Participants then rinsed with disclosing solution according to instructions. They had expectorated and rinsed with 10 mL of water for 10 seconds and expectorated again. Plaque was assessed with each tooth being divided into 6 areas including the mesiofacial, facial, distofacial, mesiolingual, lingual and distolingual surfaces. Disclosed plaque was scored as follows: 0= No plaque; 1= Slight flecks of plaque at the cervical margin of the tooth; 2= A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth; 3= A band of plaque wider than 1 mm but covering less than 1/3 of the crown of the tooth; 4= Plaque covering at least 1/3 but less tan 2/3 of the crown of the tooth; 5= Plaque covering 2/3 or more of the crown of the tooth|Baseline, 6,12 and 24 weeks|Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement||Units on a scale||Standard Error|Mean
644513|NCT02207907|Secondary|Bleeding Index at 6, 12 and 24 Weeks|The Bleeding Index was performed by a single examiner using a color coded periodontal probe. The probe was engaged approximately 1 millimetre (mm) into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system to be used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed|Baseline, 6, 12 and 24 weeks|Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement||Units on a Scale||Standard Error|Mean
644514|NCT02207907|Secondary|Modified Gingival Index (MGI) at 6 and 12 Weeks.|MGI was assessed on facial and lingual surfaces at two sites on each tooth (papillae and margin). The scoring of the MGI was performed under dental office conditions using a standard dental light for illuminating the oral cavity. Compressed air, water and mouth mirrors were available to each examiner. This procedure was performed by a single examiner. The MGI scoring system is as follows: 0 = absence of inflammation; 1 = mild inflammation; slight change in color, little change in color; little change in texture of any portion of the marginal or papillary gingival unit; 2 = mild inflammation; criteria as above but involving the entire marginal or papillar gingival units; 3= moderate inflammation; glazing, redness, edema, and/ or hypertrophy of the marginal or papillary gingival unit; 4 = severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration|Baseline, 6 and 12 weeks|Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement||Units on a scale||Standard Error|Mean
644515|NCT02207907|Secondary|Number of Gingival Bleeding Sites at 6 and 12 Weeks.|Number of gingival bleeding sites were measured as bleeding index via a single examiner using a color coded periodontal probe. The probe was engaged approximately 1 millimetre (mm) into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system used to measure bleeding sites is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed. A bleeding site was considered as a BI score of 1 or 2.|Baseline, 6 and 12 weeks|Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement||number of gingival bleeding sites||Standard Error|Mean
644559|NCT02207413|Primary|Number of Subjects Aged 3-17 Years Reporting Solicited Local Adverse Events (AEs).|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain = Cried when limb was moved/spontaneously painful. Grade 3 redness and swelling = greater than 50 millimeters (mm) i.e. >50mm.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 3 to 17 years, with at least one vaccine administration documented.||Subjects|||Number
644516|NCT02207907|Primary|Modified Gingival Index (MGI) at 24 Weeks|The Modified Gingival Index (MGI) was assessed on facial and lingual surfaces at two sites on each tooth (papillae and margin). The scoring of the MGI was performed under dental office conditions using a standard dental light for illuminating the oral cavity. Compressed air, water and mouth mirrors were available to each examiner. This procedure was performed by a single examiner. The MGI scoring system is as follows: 0 = absence of inflammation; 1 = mild inflammation; slight change in color, little change in color; little change in texture of any portion of the marginal or papillary gingival unit; 2 = mild inflammation; criteria as above but involving the entire marginal or papillar gingival units; 3= moderate inflammation; glazing, redness, edema, and/ or hypertrophy of the marginal or papillary gingival unit; 4 = severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration|Baseline, 24 weeks|Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement||Units on a scale||Standard Error|Mean
644517|NCT02207907|Primary|Number of Gingival Bleeding Sites at 24 Weeks|Number of gingival bleeding sites were measured as bleeding index via a single examiner using a color coded periodontal probe. The probe was engaged approximately 1 millimetre (mm) into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system used to measure bleeding sites is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed. A bleeding site was considered as a BI score of 1 or 2.|Baseline, 24 weeks|Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement.||number of gingival bleeding sites||Standard Error|Mean
644518|NCT02207829|Primary|Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) on Day 85|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Day 85 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Day 84 (Week 12). Trough FEV1 measurements were taken electronically by spirometry on Days 2, 28, 56, 84 and 85. Baseline trough FEV1 is the mean of the two assessments made -30 and -5 minutes (min) pre-dose on Day 1. Change from baseline was calculated as the trough FEV1 value on Day 85 minus the BL value. Analysis performed using a repeated measures model with covariates of treatment, baseline FEV1, centre group, 24 hour subset flag, Day, Day by baseline and Day by treatment interactions. The least squares mean changes are presented here.|Baseline (BL) and Day 85|Per Protocol(PP) Population(pop): Participants(par) in the Intent-To-Treat pop who did not have a full protocol deviation considered to impact efficacy. Par represent those with data available at time point presented; however, all par. in the PP pop. without missing covariate information and >=1 post BL measurement are included in analysis||Liter||Standard Error|Least Squares Mean
644519|NCT02207608|Primary|Visual Analogue Scale for Pain|1 to 10 scale (1 minimum pain perceivable; 10 unbearable pain, as perceived by the patient)|Before and after six weeks of treatment (end of induction course)|||units on a scale||Standard Deviation|Mean
644520|NCT02207478|Secondary|The Duration Time Difference of ENB-GS-TBLB With Fluoroscopy as Compared to GS-TBLB With Fluoroscopy Alone|Including total procedure time，total X-ray time, duration time for finding lesions and X-ray time for finding lesions.|Up to half year|||seconds||Standard Deviation|Mean
644521|NCT02207478|Primary|The Difference of Diagnostic Value of ENB-GS-TBLB as Compared to GS-TBLB|The diagnostic yield in the ENB-GS-TBLB and GS-TBLB group was 87.2% and 61% individually.|Up to half year|||participants|||Number
644522|NCT02207413|Secondary|Number of Subjects Aged 6-35 Months, Reporting Any and Related Serious Adverse Events (SAEs)|A serious adverse event was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|During the entire study period [approximately 28 days (primed subjects) and 56 days (unprimed subjects)]|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 to 35 months, with at least one vaccine administration documented.||Subjects|||Number
644523|NCT02207413|Secondary|Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 unsolicited AE was defined as an event that prevented normal activity. Related unsolicited AE was defined as an event assessed by the investigator to be causally related to the study vaccination.|During the 28-day (Days 0-27) follow-up period after vaccination|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 to 35 months, with at least one vaccine administration documented.||Subjects|||Number
644524|NCT02207413|Secondary|Number of Subjects Aged 6-35 Months Reporting the Occurrence of All Medically Attended Events (MAEs)|MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s). Grade 3 was a MAE that prevented normal activities. Related was defined as a MAE assessed by the investigator to be causally related to the study vaccination.|During the entire study period (approximately 28 days (primed subjects) and 56 days (unprimed subjects) following vaccination|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 to 35 months, with at least one vaccine administration documented.||Subjects|||Number
644578|NCT02206607|Secondary|PF-04937319 Plasma Concentration at 24 Hours After Morning Dose (C24)||0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose|The PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of the PK parameters of interest measured and available in at least 1 period.||ng/dL||Geometric Coefficient of Variation|Geometric Mean
644525|NCT02207413|Secondary|Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms.|Oculorespiratory syndrome (ORS) was defined as the occurrence within 24 hours after vaccination of one or more of the following newly onset symptoms: bilateral red eyes, cough, wheeze, chest tightness, difficulty breathing, difficulty swallowing, hoarseness, sore throat, facial swelling. Any = occurrence of any ORS symptom regardless of intensity grade or relationship to vaccination. Grade 3 = ORS symptoms that prevented normal activities. Related = ORS symptom assessed by the investigator as causally related to the vaccination.|During a 3 day (Days 0-2) follow-up period after vaccination|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 to 35 months, with at least one vaccine administration documented.||Subjects|||Number
644526|NCT02207413|Secondary|Duration of Solicited General AEs in Subjects Aged 6-35 Months.|Duration was defined as number of days with any grade of general symptoms.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 to 35 months, with at least one vaccine administration documented.||Days||Full Range|Median
644527|NCT02207413|Secondary|Duration of Solicited Local AEs in Subjects Aged 6-35 Months.|Duration was defined as number of days with any grade of local symptoms.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 to 35 months, with at least one vaccine administration documented.||Days||Full Range|Median
644528|NCT02207413|Secondary|Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed were drowsiness, irritability/fussiness, loss of appetite and fever. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 irritability/fussiness was defined as crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite was defined as not eating at all. Grade 3 drowsiness was defined as drowsiness that prevented normal activity. Any fever was defined as subjects with a documented temperature of greater than or equal to (≥) 38°C/100.4°F by any route and all subjects reporting temperature less than (< )38°C but with missing values (MC) for at least one day during the solicited period. Grade 3 fever was defined as temperature greater than (>)39.0°C.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 to 35 months, with at least one vaccine administration documented.||Subjects|||Number
644529|NCT02207413|Secondary|Number of Subjects Aged 6 Months to <5 Years, Reporting Fever ≥38ºC (100.4°F) and >39.0°C (102.2ºF) Across Doses.|"Any fever = all subjects with a documented temperature of ≥ 38°C/100.4°F by any route and all subjects reporting temperature < 38°C but with missing values (MC) for at least one day during the solicited period. Grade 3 fever = temperature above 39.0°C/102.2ºF.
Data of 2 independent groups were pooled."|During the 2 days (Day 0-Day 1) post-vaccination period|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 months to <5 years, with at least one vaccine administration documented.||Subjects|||Number
644530|NCT02207413|Secondary|Number of Subjects Aged 6-35 Months Reporting Solicited Local Adverse Events (AEs).|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain = significant pain at rest and pain that prevented normal everyday activities. Grade 3 redness and swelling = greater than 50 millimeters (mm) i.e. > 50mm.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 to 35 months, with at least one vaccine administration documented.||Subjects|||Number
644531|NCT02207413|Secondary|Number of Subjects Aged 6-35 Months Reporting Fever ≥38ºC After Dose 1 and After Dose 2.|"Any fever = all subjects with a documented temperature of ≥ 38°C/100.4°F by any route and all subjects reporting temperature < 38°C but with missing values (MC) for at least one day during the solicited period.
Fever = temperature of ≥ 38°C/100.4°F by any route"|During 7 days (Days 0-6) post-vaccination|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 to 35 months, with at least one vaccine administration documented.||Subjects|||Number
644532|NCT02207413|Secondary|Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains in Subjects Aged 6-35 Months.|MGI was defined as the fold increase in serum haemagglutination inhibition (HI) GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Day 28 post last vaccination|Analysis was performed on the Pediatric According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 6 months to 17 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available||Fold increase||95% Confidence Interval|Geometric Mean
644533|NCT02207413|Secondary|Number of Subjects Aged 6-35 Months, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains.|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Day 0 and Day 28 post last vaccination|Analysis was performed on the Pediatric According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 6 months to 17 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available||Subjects|||Number
644579|NCT02206607|Secondary|PF-04937319 Plasma Concentration at 16 Hours After Morning Dose (C16)||0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose|The PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of the PK parameters of interest measured and available in at least 1 period.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
644906|NCT02196714|Secondary|Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose|Change in Mean Hematology Parameters (±SD) from Pre-dose to 12 Hours Post-dose (Erythrocytes)|12 Hours|Safety Population||10^12cells/L||Standard Deviation|Mean
644534|NCT02207413|Secondary|Number of Seroconverted Subjects Aged 6-35 Months for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains.|A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Day 28 post last vaccination|Analysis was performed on the Pediatric According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 6 months to 17 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available||Subjects|||Number
644535|NCT02207413|Secondary|Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 6-35 Months by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains|HI antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Day 0 and Day 28 post last vaccination|Analysis was performed on the Pediatric According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 6 months to 17 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available||Titers||95% Confidence Interval|Geometric Mean
644536|NCT02207413|Secondary|Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains in Subjects Aged 3-17 Years.|MGI was defined as the fold increase in serum haemagglutination inhibition (HI) GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Day 28 post last vaccination|Analysis was performed on the Pediatric According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 3 to 17 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available||Fold increase||95% Confidence Interval|Geometric Mean
644537|NCT02207413|Secondary|Number of Subjects Aged 3-17 Years, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains.|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Day 0 and Day 28 post last vaccination|Analysis was performed on the Pediatric According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 6 months to 17 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available||Subjects|||Number
644538|NCT02207413|Secondary|Number of Seroconverted Subjects Aged 3-17 Years for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains.|A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Day 28 post last vaccination|Analysis was performed on the Pediatric According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 3 to 17 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available||Subjects|||Number
644539|NCT02207413|Secondary|Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 3-17 Years by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains|HI antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Day 0 and Day 28 post last vaccination|The analysis was performed on the Pediatric According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 3 to 17 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were avail||Titers||95% Confidence Interval|Geometric Mean
644540|NCT02207413|Secondary|Number of Subjects Aged 5-17 Years Reporting Myalgia Across Doses.|Any = occurrence of any myalgia symptom regardless of intensity grade or relationship to vaccination.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 5 to 17 years, with at least one vaccine administration documented.||Subjects|||Number
644541|NCT02207413|Secondary|Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains in Subjects Aged 18-49 Years.|"MGI was defined as the fold increase in serum haemagglutination inhibition (HI) GMTs post-vaccination compared to pre-vaccination (Day 0).
The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria)."|At Day 21|The analysis was performed on the Adult According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 18 to 49 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.||Fold increase||95% Confidence Interval|Geometric Mean
644580|NCT02206607|Secondary|PF-04937319 Plasma Concentration at 5 Hours After Morning Dose (C5)||0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose|The PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of the PK parameters of interest measured and available in at least 1 period.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
644542|NCT02207413|Secondary|Number of Subjects Aged 18-49 Years, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains.|"A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults.
The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria)."|At Day 0 and Day 21|The analysis was performed on the Adult According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 18 to 49 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.||Subjects|||Number
644543|NCT02207413|Secondary|Number of Seroconverted Subjects Aged 18-49 Years for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains.|"A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.
The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria)."|At Day 21|The analysis was performed on the Adult According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 18 to 49 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.||Subjects|||Number
644544|NCT02207413|Secondary|Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 18-49 Years by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains|HI antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Day 0 and Day 21|The analysis was performed on the Adult According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 18 to 49 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.||Titers||95% Confidence Interval|Geometric Mean
644545|NCT02207413|Primary|Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 6-35 Months by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains.|HI antibody titres were expressed as geometric mean titers (GMTs) and adjusted GMT ratios. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), FluA/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Day 28 post last vaccination|Analysis was performed on the Pediatric According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 6 to 35 months, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available||Titers||95% Confidence Interval|Geometric Mean
644546|NCT02207413|Primary|Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 3-17 Years by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains.|HI antibody titres were expressed as geometric mean titers (GMTs) and adjusted GMT ratios. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), FluA/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Day 28 post last vaccination|Analysis was performed on the Pediatric According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 3 to 17 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available||Titers||95% Confidence Interval|Geometric Mean
644547|NCT02207413|Primary|Number of Subjects Aged 3-17 Years, Reporting Any and Related Serious Adverse Events (SAEs)|A serious adverse event was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|During the entire study period [approximately 28 days (primed subjects) and 56 days (unprimed subjects)]|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 3 to 17 years, with at least one vaccine administration documented.||Subjects|||Number
644548|NCT02207413|Primary|Number of Subjects Aged 18-49 Years, Reporting Any and Related Serious Adverse Events (SAEs)|A serious adverse event was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|During the entire study period (approximately 21 days)|The analysis was performed on the Adult-Total Vaccinated cohort which included all subjects aged 18 to 49 years with at least one vaccine administration documented.||Subjects|||Number
644549|NCT02207413|Primary|Number of Subjects Aged 6-35 Months Reporting Fever ≥38ºC Across Doses.|Any fever = all subjects with a documented temperature of ≥ 38°C/100.4°F by any route and all subjects reporting temperature < 38°C but with missing values (MC) for at least one day during the solicited period.|During 7 days (Days 0-6) post-vaccination|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 to 35 months, with at least one vaccine administration documented.||Subjects|||Number
644581|NCT02206607|Secondary|Maximum Observed PF-04937319 Plasma Concentration (Cmax)||0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose|The PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of the PK parameters of interest measured and available in at least 1 period.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
644907|NCT02196714|Secondary|Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose|Change in Mean Hematology Parameters (±SD) from Pre-dose to 12 Hours Post-dose (Ery. mean corpuscuar hemoglobin)|12 Hours|Safety Population||pg/cell||Standard Deviation|Mean
644550|NCT02207413|Primary|Number of Subjects Aged 3-17 Years Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 28-day (Days 0-27) follow-up period after vaccination|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 months to 17 years, with at least one vaccine administration documented.||Subjects|||Number
644551|NCT02207413|Primary|Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 21-day (Days 0-20) follow-up period after vaccination|The analysis was performed on the Adult-Total Vaccinated cohort which included all subjects aged 18 to 49 years with at least one vaccine administration documented.||Subjects|||Number
644552|NCT02207413|Primary|Number of Subjects Aged 3-17 Years Reporting the Occurrence of All Medically Attended Events (MAEs) .|MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s). Grade 3 was a MAE that prevented normal activities. Related was defined as a MAE assessed by the investigator to be causally related to the study vaccination.|During the entire study period (approximately 28 days (primed subjects) and 56 days (unprimed subjects) following vaccination|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 3 to 17 years, with at least one vaccine administration documented.||Subjects|||Number
644553|NCT02207413|Primary|Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms.|"Oculorespiratory syndrome (ORS) was defined as the occurrence within 24 hours after vaccination of one or more of the following newly onset symptoms: bilateral red eyes, cough, wheeze, chest tightness, difficulty breathing, difficulty swallowing, hoarseness, sore throat, facial swelling.
Any = occurrence of any ORS symptom regardless of intensity grade or relationship to vaccination. Grade 3 = ORS symptoms that prevented normal activities. Related = ORS symptom assessed by the investigator as causally related to the vaccination."|During the 3-day (Days 0-2) post-vaccination period|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 3 to 17 years, with at least one vaccine administration documented.||Subjects|||Number
644554|NCT02207413|Primary|Duration of Solicited General AEs in Subjects Aged 5-17 Years.|Duration was defined as number of days with any grade of general symptoms.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 5 to 17 years, with at least one vaccine administration documented.||Days||Full Range|Median
644555|NCT02207413|Primary|Duration of Solicited General AEs in Subjects Aged 3-4 Years.|Duration was defined as number of days with any grade of general symptoms.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 3 to 4 years, with at least one vaccine administration documented.||Days||Full Range|Median
644556|NCT02207413|Primary|Duration of Solicited Local AEs in Subjects Aged 3-17 Years.|Duration was defined as number of days with any grade of local symptoms.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 3 to 17 years, with at least one vaccine administration documented.||Days||Full Range|Median
644557|NCT02207413|Primary|Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache, joint pain, myalgia, shivering and fever (Fever = temperature above 38.0 degrees Celsius (°C)). Gastrointestinal symptoms included nausea, vomiting, diarrhoea and/or abdominal pain. Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Any fever = all subjects with a documented temperature of ≥ 38°C/100.4°F by any route and all subjects reporting temperature < 38°C but with missing values (MC) for at least one day during the solicited period. Grade 3 fever = temperature above 39.0°C.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 5 to 17 years, with at least one vaccine administration documented.||Subjects|||Number
644558|NCT02207413|Primary|Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed were drowsiness, irritability/fussiness, loss of appetite and fever. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 irritability/fussiness was defined as crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite was defined as not eating at all. Grade 3 drowsiness was defined as drowsiness that prevented normal activity. Any fever was defined as subjects with a documented temperature of greater than or equal to (≥) 38°C/100.4°F by any route and all subjects reporting temperature less than (< )38°C but with missing values (MC) for at least one day during the solicited period. Grade 3 fever was defined as temperature greater than (>) 39.0°C.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 3 to 4 years, with at least one vaccine administration documented.||Subjects|||Number
644632|NCT02204579|Primary|Change From Baseline in Serum Calcium at 12 Hours Postdose||Baseline (Predose) to 12 Hours Postdose|Post-amendment PD analysis population included all participants who received at least 5 minutes of the study drug infusion and had at least one PD measurement on at least 1 day of infusion. Here, n=number of participants analysed for specified category at the specified time points in each arm respectively.||millimole/liter (mmol/L)||Standard Deviation|Mean
644560|NCT02207413|Primary|Number of Subjects Aged 18-49 Years Reporting the Occurrence of Medically Attended Events (MAEs).|MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s). Grade 3 was defined as MAE that prevented normal activities. Related was defined as MAE assessed by the investigator to be causally related to the study vaccination.|During the entire study period (approximately 21 days following vaccination)|"The analysis was performed on the Adult-Total Vaccinated cohort which included all subjects aged 18 to 49 years with at least one vaccine administration documented.
1 subject withdrew consent in the Influsplit Tetra_LP Adult Group and did not complete the study but was administered a study vaccine dose."||Subjects|||Number
644561|NCT02207413|Primary|Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms.|Oculorespiratory syndrome (ORS) was defined as the occurrence within 24 hours after vaccination of one or more of the following newly onset symptoms: bilateral red eyes, cough, wheeze, chest tightness, difficulty breathing, difficulty swallowing, hoarseness, sore throat, facial swelling. Any was defined as any ORS symptom regardless of intensity grade or relationship to vaccination. Grade 3 ORS was defined as ORS symptoms that prevented normal activities. Related ORS was defined as ORS symptom(s) assessed by the investigator as causally related to the vaccination.|During the 3-day (Days 0-2) post-vaccination period|The analysis was performed on the Adult-Total Vaccinated cohort which included all subjects aged 18 to 49 years with at least one vaccine administration documented.||Subjects|||Number
644562|NCT02207413|Primary|Duration of Solicited Local and General AEs in Subjects Aged 18-49 Years.|Duration was defined as number of days with any grade of local and general symptoms.|During the 7-day (Days 0-6) post-vaccination period|"The analysis was performed on the Adult-Total Vaccinated cohort which included all subjects aged 18 to 49 years with at least one vaccine administration documented.
N = Number of subjects with the symptom and without the missing confirmed grade"||Days||Full Range|Median
644563|NCT02207413|Primary|Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed were fatigue,gastrointestinal symptoms, headache, Joint Pain, myalgia, shivering and fever. Gastrointestinal symptoms included nausea, vomiting, diarrhoea and/or abdominal pain. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Grade 3 was defined as symptoms that prevented normal activities. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Any fever was defined as subjects with a documented temperature of greater than or equal to (≥) 38°C/100.4°F by any route and all subjects reporting temperature less than (< )38°C but with missing values (MC) for at least one day during the solicited period. Grade 3 fever was defined as temperature ≥39.0°C.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Adult-Total Vaccinated cohort which included all subjects aged 18 to 49 years with at least one vaccine administration documented.||Subjects|||Number
644564|NCT02207413|Primary|Number of Subjects Aged 18-49 Years Reporting Solicited Local Adverse Events (AEs).|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain = significant pain at rest and pain that prevented normal everyday activities. Grade 3 redness and swelling = greater than 100 millimeters (mm) i.e. >100mm.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Adult-Total Vaccinated cohort which included all subjects aged 18 to 49 years with at least one vaccine administration documented.||Subjects|||Number
644565|NCT02207400|Secondary|Bacterial Count at Baseline, After 6, 12, 24 and 32 Weeks|Microbiological samples were collected at baseline, 6 weeks, 12 weeks, 24 weeks and 32 weeks. Plaque was harvested from contra-lateral 1st molar teeth, where no restorations are present, using a sterile paper point. The paper point was immersed into 4 ml of Calgon Ringer's solution in a sterile bijou and kept on ice until they can be taken to the laboratory for processing (within 24 hours).|Baseline, 6, 12, 24 and 32 weeks|ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement.||colony forming units per sample||Standard Deviation|Mean
644566|NCT02207400|Secondary|Plaque Control (Overall and Interproximal Dental Plaque Scores) at 6, 12 and 24 Weeks.|The dental examiner had used the Turesky Modification of the Quigley Hein Index to assess plaque on all gradable teeth. Interproximal Dental Plaque Scores were analyzed in the same way as for Overall scores but just based on mesiofacial, facial, distofacial, mesiolingual, lingual and distolingual surfaces. Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5: 0= No plaque; 1= Slight flecks of plaque at the cervical margin of the tooth; 2= A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth; 3= A band of plaque wider than 1 mm but covering less than 1/3 of the crown of the tooth; 4= Plaque covering at least 1/3 but less than 2/3 of the crown of the tooth; 5= Plaque covering 2/3 or more of the crown of the tooth.|6, 12 and 24 weeks|ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement.||Units on a scale||Standard Deviation|Mean
644567|NCT02207400|Secondary|Bleeding Index (BI) at 6, 12 and 24 Weeks|BI was performed by a single examiner using a color coded periodontal probe. The probe was engaged approximately 1mm into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed|6, 12 and 24 weeks|ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement.||Units on a Scale||Standard Deviation|Mean
644582|NCT02206607|Primary|Change From Reference in Weighted-Mean-Daily-Glucose (WMDG) on Day 1|MWG was calculated as the area under the curve (AUC) for the full 24 hours expressed.|0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, and 24 hours post-dose|The pharmacodynamic analysis included participants who had taken at least 1 dose of PF-04937319 and who had WMDG assessment for at least 1 modified-release formulation and the Reference (IR MST) formulation; n=number of participants evaluated in respective arms for category.||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
644647|NCT02204371|Secondary|Number of Participants With Urinalysis Data Meeting Criteria of Potential Clinical Concern|Protein – values of clinical concern if change from “trace” at baseline to 3+ any time on-therapy or from 0 at baseline to 2+ any time on-therapy.|Up to Week 16|Safety Population||Participants|||Number
644568|NCT02207400|Secondary|Modified Gingival Index (MGI)) at 6 and 12 Weeks.|MGI was assessed on facial and lingual surfaces at two sites on each tooth (papillae and margin). The scoring of the MGI was performed under dental office conditions using a standard dental light for illuminating the oral cavity. Compressed air, water and mouth mirrors were available to each examiner. This procedure was performed by a single examiner. The MGI scoring system is as follows: 0 = absence of inflammation; 1 = mild inflammation; slight change in color, little change in color; little change in texture of any portion of the marginal or papillary gingival unit; 2 = mild inflammation; criteria as above but involving the entire marginal or papillar gingival units; 3= moderate inflammation; glazing, redness, edema, and/ or hypertrophy of the marginal or papillary gingival unit; 4 = severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration|6 and 12 weeks|ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement.||Units on a scale||Standard Deviation|Mean
644569|NCT02207400|Secondary|Number of Gingival Bleeding Sites at 6 and 12 Weeks|BI was performed by a single examiner using a color coded periodontal probe. The probe was engaged approximately 1mm into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed|Baseline, 6 and 12 weeks|ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement.||Number of bleeding sites||Standard Deviation|Mean
644570|NCT02207400|Primary|Modified Gingival Index (MGI) at 24 Weeks|MGI was assessed on facial and lingual surfaces at two sites on each tooth (papillae and margin). The scoring of the MGI was performed under dental office conditions using a standard dental light for illuminating the oral cavity. Compressed air, water and mouth mirrors were available to each examiner. This procedure was performed by a single examiner. The MGI scoring system is as follows: 0 = absence of inflammation; 1 = mild inflammation; slight change in color, little change in color; little change in texture of any portion of the marginal or papillary gingival unit; 2 = mild inflammation; criteria as above but involving the entire marginal or papillar gingival units; 3= moderate inflammation; glazing, redness, edema, and/ or hypertrophy of the marginal or papillary gingival unit; 4 = severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration|24 weeks|ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement.||Units on a scale||Standard Deviation|Mean
644571|NCT02207400|Primary|Number of Gingival Bleeding Sites at 24 Weeks|The Bleeding Index was performed by a single examiner using a color coded periodontal probe. The probe was engaged approximately 1 millimetre (mm) into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed|24 weeks|ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement.||Number of bleeding sites||Standard Deviation|Mean
644572|NCT02206776|Primary|Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale.|Patients given YBOCS (Yale Brown Obsessive-Compulsive Scale), a gold standard measure of obsessions and compulsions. For the YBOCS the minimum units are 0 and Maximum units on the total scale are 40. The higher the number on the YBOCS, the more severe the symptoms. Response was defined as at least a 35% reduction on the YBOCS.|Baseline and 1 Week|||Participants|||Count of Participants
644573|NCT02206607|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.|Baseline up to 28 days after last study drug administration in Period 4|The safety analysis population included all participants who received at least 1 dose of open-label, sponsor-provided metformin.||participants|||Number
644574|NCT02206607|Secondary|Terminal Elimination Half-Life (t1/2)|t1/2 is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose|The PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of the PK parameters of interest measured and available in at least 1 period; number of participants analyzed (N) is number of evaluable participants for this outcome measure.||hour||Standard Deviation|Mean
644575|NCT02206607|Secondary|Area Under the Curve From Time Zero to Last Quantifiable PF-04937319 Concentration (AUClast)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose|The PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of the PK parameters of interest measured and available in at least 1 period.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
644576|NCT02206607|Secondary|Time to Reach Maximum Observed PF-04937319 Plasma Concentration (Tmax)||0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose|The PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of the PK parameters of interest measured and available in at least 1 period.||hours||Full Range|Median
644577|NCT02206607|Secondary|Ratio of Maximum to Approximate Trough PF-04937319 Concentration (Cmax/C24)|Cmax/C24 is the ratio of maximum to approximate trough concentration, where Cmax is the overall maximum observed plasma concentration and C24 is the plasma concentration at 24 hours after the morning dose.|0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose|The PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of the PK parameters of interest measured and available in at least 1 period.||ratio||Geometric Coefficient of Variation|Geometric Mean
644583|NCT02206607|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf]|AUCinf is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time.|0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose|The pharmacokinetic (PK) parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of the PK parameters of interest measured and available in at least 1 period; number of participants analyzed (N) is number of evaluable participants for this outcome measure.||nanogram*hour/milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
644584|NCT02205814|Secondary|Euro Quality of Life Questionnaire (EQ-5D-5L) Responder Rate|Response based on change ≥ 20 % from baseline for EQ-5D-5L index value|from baseline up to 6 weeks after randomisation|The secondary efficacy analysis was performed on the ITT-population (n=431).||percentage of responders|||Number
644585|NCT02205814|Secondary|Responder Rate According to OMERACT-OARSI Criteria|Percentage of responders according to Outcome Measures in Rheumatology-Osteoarthritis Research Society International criteria (OMERACT-OARSI criteria). Patients with at least 50 % improvement in pain or in function scores are considered responders. Alternatively, patients are considered responders if they show at least 20% improvement in at least two of the following scores: pain, function and Patients's Global Assessment (PGA) scores.|from baseline up to 6 weeks after randomisation|The secondary efficacy variables were analysed in the ITT population (n=431).||percentage of responders|||Number
644586|NCT02205814|Secondary|Change in WOMAC INDEX|The WOMAC VA 3.1 Index score (WOMAC INDEX) is the sum of WOMAC A (total pain), WOMAC B (stiffness) and WOMAC C (functional impairment) subscores. The WOMAC INDEX score ranges from 0 to 2400 mm, with higher scores indicating higher disease burden.|from baseline up to 6 weeks after randomisation|The secondary efficacy analysis was performed on the ITT population (n=431).||units on a scale||Standard Deviation|Mean
644587|NCT02205814|Primary|Change in WOMAC A|The validated Western Ontario and McMaster University questionnaire (WOMAC) was used to measure total knee pain choosing its visual analogue scale version (VAS). The WOMAC VA 3.1 A subscore (WOMAC A) ranges from 0 to 500 mm (summing up five VAS 0-100 mm) with higher scores indicating more pain.|from baseline up to 2 weeks after randomisation|The primary efficacy analysis was performed on the ITT-population (n=431).||units on a scale||Standard Deviation|Mean
644588|NCT02205476|Other Pre-specified|Volumetric & Colorimetric Scar Assessment (3D Imaging) at Part A Visit|Three-dimension digital photography was planned to be taken of the participants scars for determination of scar volume, height, and color performed in a subset of selected investigational centers equipped with specialized 3D photographic equipment.|52 weeks after initial scar revision surgery in study B5301001|The volumetric and colorimetric scar assessments were collected under this protocol but were not analyzed.|||||
644589|NCT02205476|Primary|Part B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs)|An Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 112 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Data for this outcome measure was not analyzed because part B was not initiated due to early termination of the study during Part A.|Part B: Baseline up to Week 15|Data for this outcome measure was not analyzed because part B was not initiated due to early termination of the study during Part A.|||||
644590|NCT02205476|Primary|Part B: Number of Participants With Clinical Laboratory Abnormalities|Clinical laboratory tests included clinical chemistry (sodium, potassium, chloride, bicarbonate, glucose, blood urea nitrogen (BUN), creatinine, albumin, calcium, total, direct and indirect bilirubin, gamma-glutamyltransferase (GGT), alanine aminotransferase (ALT), aspartate aminotransferase (AST), lactic dehydrogenase (LDH), alkaline phosphatase, creatine phosphokinase (CPK), uric acid, amylase and lipase) and hematology (hemoglobin, hematocrit, red blood cell count (RBC), white blood cell count (WBC) with differential, and platelet count) tests to be performed.|Part B: Baseline up to Week 15|Data for this outcome measure was not analyzed because part B was not initiated due to early termination of the study during Part A.|||||
644591|NCT02205476|Primary|Part B: Number of Participants With Clinically Significant Vital Sign Abnormalities|Vital signs included pulse rate and systolic blood pressure and diastolic blood pressure.|Part B: Baseline up to Week 15|Data for this outcome measure was not analyzed because part B was not initiated due to early termination of the study during Part A.|||||
644592|NCT02205476|Secondary|Physician and Participant Photoguide Scar Assessment Scale Score at Part A Visit|Physician and participants rated severity of each scar using a photonumeric guide on a scale ranging from 1 to 5 (where 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe).|52 weeks after initial scar revision surgery in study B5301001|Enrolled analysis set included all participants who signed an informed consent and for whom data were collected for Part A of this trial.||units on scale||Standard Deviation|Mean
644593|NCT02205476|Secondary|Patient-Reported Scar Evaluation Questionnaire (PR-SEQ) Symptom and Appearance Domain Score at Part A Visit|PR-SEQ questionnaire consisted of 30 different attributes of scars that included following four dimensions: appearance (5 attributes), symptoms (3 attributes), bothersomeness (8 attributes), and impacts on the quality of life (physical and emotional wellbeing [14 attributes]). Each question had 5 possible responses: not at all (0), slightly (1), moderately (2), very (3), and extremely (4). Subjects completed an abbreviated version which included only the Symptoms and Appearance dimensions to evaluate treatment outcomes. Each of the item scores were transformed into a 0 to 100 scale. Each dimension score was calculated from averaging the transformed scores (0 to 100 scaled) for specified items. Each domain score ranged from 0 to 100, with higher scores indicating higher severity.|52 weeks after initial scar revision surgery in study B5301001|Enrolled analysis set included all participants who signed an informed consent and for whom data were collected for Part A of this trial.||units on scale||Standard Deviation|Mean
644629|NCT02204579|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC[0-t]) of NPSP795||Baseline (Predose), and 15, 30 Minutes, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 5.5 and 8 Hours Postdose|Post amendment pharmacokinetic (PK) analysis population included all participants who received at least 5 minutes of the study drug infusion and had at least one PK measurement on at least 1 day of infusion.||nanogram*hour per millilitre (ng·h/mL)||Standard Deviation|Mean
644594|NCT02205476|Secondary|Patient Global Assessment Using Overall Opinion of Patient and Observer Scar Assessment Scale (POSAS) at Part A Visit|Patient global assessment was performed using the overall opinion question of the POSAS scale. Participants were asked to rate the severity of their scar compared to normal skin. The overall opinion scale score ranged from 1 (normal skin) to 10 (very different from normal skin).|52 weeks after initial scar revision surgery in study B5301001|Enrolled analysis set included all participants who signed an informed consent and for whom data were collected for Part A of this trial.||units on scale||Standard Deviation|Mean
644595|NCT02205476|Primary|Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) at Part A Visit|Physician scar assessment was performed using 10-point POSAS scale. Physician rated each of the items (vascularity, pigmentation, thickness, relief, pliability, surface area and overall opinion) for a scar on a score of 1 (normal skin) to 10 (worst scar imaginable).|52 weeks after initial scar revision surgery in study B5301001|Enrolled analysis set included all participants who signed an informed consent and for whom data were collected for Part A of this trial.||units on scale||Standard Deviation|Mean
644596|NCT02205333|Secondary|Number of Participants Positive for Human Anti-mouse Antibodies (HAMA)|The number of participants who developed detectable HAMA are presented. ImmuSTRIP® HAMA IgG ELISA Test System was used for detection, confirmation, and titration of HAMA in human serum with a HAMA positivity cut-off level of 74 nanogram per millilitre (ng/mL).|All treatment arms: Days 8, 15, 29, and end of treatment (up to 1 year). Additionally for MEDI6469 + rituximab arm: Days 3, 31, 59, and every 28 days thereafter until end of treatment (up to 1 year)|All the participants who received at least a one dose of MEDI6469.||Participant|||Number
644597|NCT02205333|Secondary|Terminal Phase Elimination Half-Life (T1/2)|The PK parameter was estimated using the non-compartmental analysis methods, based on the participant serum concentration-time data. The concentration-time curve was the result of blood sampling at specified time points and its measured concentration of MEDI6469|MEDI6469 monotherapy: Days 1, 2, 3, 8, 15, and 29; MEDI6469 + tremelimumab or durvalumab: Days 1, 2, 3, 4, 8, 15, 29, and end of treatment (up to 1 year); MEDI6469 + rituximab: Days 3, 4, 8, 15, 29, 31, 59, every 28 days thereafter, and end of treatment.|All the participants who received at least a one dose of MEDI6469 and for whom PK blood samples were collected and evaluated.||Day||Standard Deviation|Mean
644598|NCT02205333|Secondary|Systemic Clearance (CL)|The PK parameter was estimated using the non-compartmental analysis methods, based on the participant serum concentration-time data. The concentration-time curve was the result of blood sampling at specified time points and its measured concentration of MEDI6469|MEDI6469 monotherapy: Days 1, 2, 3, 8, 15, and 29; MEDI6469 + tremelimumab or durvalumab: Days 1, 2, 3, 4, 8, 15, 29, and end of treatment (up to 1 year); MEDI6469 + rituximab: Days 3, 4, 8, 15, 29, 31, 59, every 28 days thereafter, and end of treatment.|All the participants who received at least a one dose of MEDI6469 and for whom PK blood samples were collected and evaluated.||liter per day||Standard Deviation|Mean
644599|NCT02205333|Secondary|Area Under the Serum Concentration-time Curve From Time Zero to Infinity (AUC0-inf)|The PK parameter was estimated using the non-compartmental analysis methods, based on the participant serum concentration-time data. The concentration-time curve was the result of blood sampling at specified time points and its measured concentration of MEDI6469|MEDI6469 monotherapy: Days 1, 2, 3, 8, 15, and 29; MEDI6469 + tremelimumab or durvalumab: Days 1, 2, 3, 4, 8, 15, 29, and end of treatment (up to 1 year); MEDI6469 + rituximab: Days 3, 4, 8, 15, 29, 31, 59, every 28 days thereafter, and end of treatment.|All the participants who received at least a one dose of MEDI6469 and for whom PK blood samples were collected and evaluated.||day*microgram per milliliter||Standard Deviation|Mean
644600|NCT02205333|Secondary|Maximum Observed Serum Concentration (Cmax)|The pharmacokinetics (PK) parameter was estimated using the non-compartmental analysis methods, based on the participant serum concentration-time data. The concentration-time curve was the result of blood sampling at specified time points and its measured concentration of MEDI6469|MEDI6469 monotherapy: Days 1, 2, 3, 8, 15, and 29; MEDI6469 + tremelimumab or durvalumab: Days 1, 2, 3, 4, 8, 15, 29, and end of treatment (up to 1 year); MEDI6469 + rituximab: Days 3, 4, 8, 15, 29, 31, 59, every 28 days thereafter, and end of treatment|All the participants who received at least a one dose of MEDI6469 and for whom PK blood samples were collected and evaluated.||microgram per milliliter||Standard Deviation|Mean
644601|NCT02205333|Secondary|Overall Survival (OS)|The OS was the duration from the start of study treatment until death due to any cause.|From Study entry until early termination (up to 1 year)|As-treated population||Months||95% Confidence Interval|Median
644602|NCT02205333|Secondary|Progression-free Survival (PFS)|Progression-free survival was the duration measured from the start of study treatment until the first documentation of PD or death due to any cause, whichever occurred first. Progression was based on revised RECIST v1.1 criteria for monotherapy and combination tremelimumab and durvalumab arms, and Cheson criteria for combination rituximuab arms. PD according to revised RECIST v1.1 was defined as: at least a 20% increase in the sum of diameters of target lesions, or a substantial worsening in a non-target lesion, or the appearance of new lesions. PD per Cheson criteria was defined as: any new lesion or increase by at least 50% of previously involved sites from nadir.|From Study entry until early termination (up to 1 year)|As-treated population||Months||95% Confidence Interval|Median
644603|NCT02205333|Secondary|Duration of Response (DOR)|Duration of response was the duration from the first documented objective response to the first documented PD or death due to any cause, whichever occurred first. Progression was based on revised RECIST v1.1 criteria for monotherapy and combination tremelimumab and durvalumab arms, and Cheson criteria for combination rituximuab arms. PD according to revised RECIST v1.1 was defined as: at least a 20% increase in the sum of diameters of target lesions, or a substantial worsening in a non-target lesion, or the appearance of new lesions. PD per Cheson criteria was defined as: any new lesion or increase by at least 50% of previously involved sites from nadir.|From Study entry until early termination (up to 1 year)|All the participants with an OR were included.||Days|||Number
644630|NCT02204579|Primary|Change From Baseline in Serum Parathyroid Hormone (PTH) at Specified Time Point||Baseline (Predose), 5.5 Hours, 8 Hours Postdose|Post amendment PD analysis population included all participants who received at least 5 minutes of the study drug infusion and had at least one PD measurement on at least 1 day of infusion. Here, n=number of participants analysed for specified category at the specified time points in each arm respectively.||nanogram/liter (ng/L)||Standard Deviation|Mean
648279|NCT02107014|Primary|Change in IL-8 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].|||pg/mL||95% Confidence Interval|Median
644604|NCT02205333|Secondary|Disease Control Rate|Disease control rate: Percentage of participants with CR, PR, or SD (if they maintained SD for >= 8 weeks) according to revised RECIST v1.1 for monotherapy and combination tremelimumab and durvalumab arms, and Cheson criteria for combination rituximuab arms. Tumor assessments according to revised RECIST v1.1 were defined as follows: CR -disappearance of all target/non-target lesions; PR - at least a 30% decrease in sum of diameters of target lesions; SD - neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; PD - at least a 20% increase in sum of diameters of target lesions, or a substantial worsening in a non-target lesion, or the appearance of new lesions. Tumor assessments according to Cheson criteria were defined as follows: CR- disappearance of all evidence of disease; PR - regression of measurable disease and no new sites; SD- failure to attain CR/PR or PD; PD- any new lesion or increase by at least 50% of previously involved sites from nadir.|From study entry until early termination (up to 1 year)|As-treated population||Percentage of participants|||Number
644605|NCT02205333|Secondary|Objective Response Rate (ORR)|Objective response rate was defined as the percentage of participants with confirmed CR or confirmed PR according to revised RECIST v1.1 for monotherapy and combination tremelimumab and durvalumab arms, and Cheson criteria for combination rituximuab arms. Confirmed CR and PR were those that persisted on repeat consecutive assessment >= 4 weeks after the initial documentation of response. Tumor assessments according to revised RECIST v1.1 were defined as follows: CR - disappearance of all target/non-target lesions; PR - at least a 30% decrease in the sum of the diameters of target lesions. Tumor assessments according to Cheson criteria were defined as follows: CR - disappearance of all evidence of disease; PR- regression of measurable disease and no new sites.|From study entry until early termination (up to 1 year)|As-treated population||Percentage of participants|||Number
644606|NCT02205333|Secondary|Best Overall Response (BOR)|Best overall response: Percentage (%) of participants with CR, partial response (PR), stable disease (SD), progressive disease (PD), or non-evaluable disease based on revised Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST v1.1) for monotherapy and combination tremelimumab and durvalumab arms, and Cheson criteria for combination rituximuab arms. Per RECIST v1.1: CR-disappearance of all target/non-target lesions; PR at least a 30% decrease in sum of diameters of target lesions; SD-neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; PD-at least a 20% increase in sum of diameters of target lesions, or a substantial worsening in a non-target lesion, or the appearance of new lesions. Per Cheson criteria: CR-disappearance of all evidence of disease; PR-regression of measurable disease and no new sites; SD-failure to attain CR/PR or PD; PD-any new lesion or increase by at least 50% of previously involved sites from nadir.|From study entry until early termination (up to 1 year)|As-treated population||Percentage of participants|||Number
644607|NCT02205333|Primary|Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as TEAEs|Electrocardiogram (ECG) parameters included atrial rate, PR interval, QRS duration, QTC interval, QT interval, and ventricular rate. All 12-lead ECGs performed during the study were obtained in triplicate. The TEAEs related to these ECG evaluation abnormalities were reported.|From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)|As-treated population||Participant|||Number
644608|NCT02205333|Primary|Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as TEAEs|Vital signs examination included assessment of temperature, blood pressure, pulse rate, and respiratory rate. Physical examination included assessments of head, eyes, ears, nose, throat, respiratory, cardiovascular, gastrointestinal, urogenital, musculoskeletal, neurological, psychiatric, dermatological, hematologic/lymphatic, and endocrine systems. The TEAEs related to these vital sign and physical examination abnormalities were reported.|From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)|As-treated population||Participant|||Number
644609|NCT02205333|Primary|Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs|Laboratory evaluations of blood and urine samples were performed, including hematology (white blood cell [WBC] count with differential, red blood cell [RBC] count, hematocrit, hemoglobin, platelet count, mean corpuscular volume [MCV], and mean corpuscular hemoglobin concentration [MCHC]); serum chemistry (calcium, chloride, magnesium, creatinine, sodium, blood urea nitrogen [BUN], bicarbonate, glucose, aspartate transaminase [AST], total bilirubin, C-reactive protein, gamma-glutamyl transpeptidase [GGT], lactate dehydrogenase, uric acid, potassium, alanine transaminase [ALT], alkaline phosphatase, albumin, total protein, triglycerides, and cholesterol); urinalysis; and coagulation parameters.|From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)|As-treated population||Participant|||Number
644610|NCT02205333|Primary|Number of Participants With Treatment-emergent Serious Adverse Events|A serious adverse event (SAE) was any AE that resulted in death, immediately life threatening, required (or prolonged) inpatient (or existing) hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly or birth defect in offspring of the participant, or an important medical event that could jeopardize the participant or required medical intervention to prevent one of the outcomes listed above. Treatment-emergent SAEs were defined as SAEs present at baseline that worsened in intensity after administration of study treatment or SAEs absent at baseline that emerged after administration of study treatment.|From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)|As-treated population||Participant|||Number
644611|NCT02205333|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs)|An adverse event (AE) was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study treatment, whether or not considered related to the study treatment. TEAEs were events present at baseline that worsened in intensity after administration of study treatment or events absent at baseline that emerged after administration of study treatment.|From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)|As-treated population: all the participants who received any study treatment.||Participant|||Number
644631|NCT02204579|Primary|Change From Baseline in Urinary Calcium at 12 Hours Postdose||Baseline (Predose) to 12 Hours Postdose|PD analysis population included all participants who received at least 5 minutes of the study drug infusion and had at least one PD measurement on at least 1 day of infusion. Here, n=number of participants analysed for specified category at the specified time points in each arm respectively.||millimole/liter (mmol/L)||Standard Deviation|Mean
644612|NCT02205333|Primary|Number of Participants With DLTs|The DLT was any Grade 3 or higher treatment-related toxicity (including liver transaminase elevation higher than 8×upper limit of normal [ULN] or total bilirubin higher than 5×ULN; any >=Grade 2 pneumonitis that did not resolve to <=Grade 1 within 3 days) that occurred during the DLT time frame, and excluded the following: Grade 3 fatigue for less than or equal to (<=) 7 days; Grade 3 endocrinopathy that was managed and the participant was asymptomatic; Grade 3 inflammatory reaction attributed to a local antitumor response that resolved to <=Grade 1 within 30 days; concurrent vitiligo or alopecia of any grade; Grade 3 infusion-related reaction that resolved within 6 hours; and any more than or equal to (>=) Grade 3 lymphopenia (unless clinically significant).|From the first dose of study treatment through 28 days after the first dose (up to 28 days)|DLT-evaluable population||Participant|||Number
644613|NCT02205333|Primary|Maximum Tolerated Dose (MTD) of MEDI6469|The MTD was the highest dose within a cohort where no more than 1 out of 6 participants experienced dose-limiting toxicities (DLTs) or the highest protocol-defined dose for each agent in the absence of exceeding the MTD.|From the first dose of study treatment through 28 days after the first dose (up to 28 days)|DLT-evaluable population: All participants enrolled in the dose-escalation phase who received study treatment per protocol during the first 28 days and completed safety follow-up through the DLT-evaluation period or experienced any DLT.||milligram per kilogram (mg/kg)|||Number
644614|NCT02204748|Primary|Femoro-tibial Kinematics - Ramp Down|Degree of axial rotation and maximum weight-bearing range-of-motion for implanted knee in vivo under fluoroscopic surveillance during ramp down activity.|3 months post-operative|||degrees||Standard Deviation|Mean
644615|NCT02204748|Primary|Femoro-tibial Kinematics - Gait|Degree of axial rotation and weight-bearing range-of-motion for implanted knee in vivo under fluoroscopic surveillance during gait activity.|3 months post-operative|||degrees||Standard Deviation|Mean
644616|NCT02204748|Primary|Femoro-tibial Kinematics - Deep Knee Bend|Degree of axial rotation and weight-bearing range-of-motion for implanted knee in vivo under fluoroscopic surveillance during deep knee bend activity.|3 months post-operative|||degrees||Standard Deviation|Mean
644617|NCT02204748|Secondary|Max Ground Reaction Force - Ramp Down|"Collected simultaneously with fluoroscopy data, ground reaction forces were obtained using a force plate (fixed to the ground) while subject performed activity. Maximum force measured in the vertical direction measured during the described activity was normalized with respect to participant's body weight. As such, the data are presented as the percentage of the individuals' body weight that was supported on the implanted knee using a force plate (fixed to the ground) and has been termed maximum reaction force."|3 months post-operative|||percentage of body weight||Standard Deviation|Mean
644618|NCT02204748|Secondary|Max Ground Reaction Force - Gait|"Collected simultaneously with fluoroscopy data, ground reaction forces were obtained using a force plate (fixed to the ground) while subject performed activity. Maximum force measured in the vertical direction measured during the described activity, then normalized with respect to participant's body weight. As such, the data are presented as the percentage of the individuals' body weight that was supported on the implanted knee using a force plate (fixed to the ground) and has been termed maximum reaction force."|3 months post-operative|||percentage of body weight||Standard Deviation|Mean
644619|NCT02204748|Secondary|Max Ground Reaction Force - Deep Knee Bend|"Collected simultaneously with fluoroscopy data, ground reaction forces were obtained using a force plate (fixed to the ground) while subject performed activity. Maximum force measured in the vertical direction measured during the described activity, then normalized with respect to participant's body weight. As such, the data are presented as the percentage of the individuals' body weight that was supported on the implanted knee using a force plate (fixed to the ground) and has been termed maximum reaction force."|3 months post-operative|||percentage of body weight||Standard Deviation|Mean
644620|NCT02204748|Primary|Femoro-tibial Kinematics: Translation and Lift-off for Ramp Down|Amount of translation and lift-off for implanted knee in vivo under fluoroscopic surveillance during ramp down activity.|3 months post-operative|||mm||Standard Deviation|Mean
644621|NCT02204748|Primary|Femoro-tibial Kinematics: Translation and Lift-off for Gait|Amount of translation and lift-off for implanted knee in vivo under fluoroscopic surveillance during gait activity.|3 months post-operative|||mm||Standard Deviation|Mean
644622|NCT02204748|Primary|Femoro-tibial Kinematics - Translation and Lift-off for Deep Knee Bend|Amount of translation and lift-off for implanted knee in vivo under fluoroscopic surveillance during deep knee bend activity.|3 months post-operative|||mm||Standard Deviation|Mean
644623|NCT02204657|Secondary|Hypoglycemia||28 weeks until delivery|||episodes per patient||Inter-Quartile Range|Median
644624|NCT02204657|Primary|Glycemic Control by Measurement of HbA1c||From 28 weeks until delivery|||mean percentage||Standard Deviation|Mean
644625|NCT02204579|Secondary|Change From Baseline in Fractional Excretion of Calcium (FECa) at 12 Hours Postdose||Baseline (Predose) to 12 Hours Postdose|Post-amendment PD analysis population included all participants who received at least 5 minutes of the study drug infusion and had at least one PD measurement on at least 1 day of infusion. Here n=number of participants analysed for specified category at the specified time points in each arm respectively.||Fraction of excretion||Standard Deviation|Mean
644626|NCT02204579|Secondary|Elimination Half-life (t1/2) of NPSP795 in Plasma||Baseline (Predose), and 15, 30 minutes, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 5.5 and 8 Hours Postdose|Post amendment PK analysis population included all participants who received at least 5 minutes of the study drug infusion and had at least one PK measurement on at least 1 day of infusion.||hour||Standard Deviation|Mean
644627|NCT02204579|Secondary|Maximum Observed Drug Concentration (Cmax) of NPSP795 in Plasma||Baseline (Predose), and 15, 30 minutes, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 5.5 and 8 Hours Postdose|Post amendment PK analysis population included all randomized participants who received at least 5 minutes of the study drug infusion and had at least one PK measurement on at least one day of infusion.||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
644628|NCT02204579|Secondary|Area Under the Concentration Time Curve Extrapolated to Infinity (AUC0-infinity) of NPSP795||Baseline (Predose), and 15, 30 minutes, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 5.5 and 8 Hours Postdose|Post amendment PK analysis population included all participants who received at least 5 minutes of the study drug infusion and had at least one PK measurement on at least 1 day of infusion.||nanogram*hour per milliliter(ng·h/mL)||Standard Deviation|Mean
646825|NCT02138097|Secondary|Proportion of Days Covered for MarketScan Patients|Number of days supply dispensed divided by number of days followed|up to 12 months|All patients in MarketScan cohort||days covered||Standard Deviation|Mean
644633|NCT02204579|Primary|Change From Baseline in Ionised Calcium at Specified Timepoint||Baseline (Predose), 4 Hours and 8 Hours Postdose|Post-amendment pharmacodynamic (PD) analysis population included all participants who received at least 5 minutes of the study drug infusion and had at least one PD measurement on at least 1 day of infusion. Here, n=number of participants analysed for specified category at the specified time points in each arm respectively.||millimole/liter (mmol/L)||Standard Deviation|Mean
644634|NCT02204579|Primary|Number of Participants With Clinically Significant Abnormalities Related to Physical Examination||From Day 1 up to safety follow-up assessment (upto Day 17 after discharge)|Safety population included all participants who received at least 1 minute of study drug infusion (both pre-amendment and post-amendment participants).||participants|||Number
644635|NCT02204579|Primary|Number of Participants With Potentially Clinically Important Laboratory Abnormalities||From Day 1 up to safety follow-up assessment (upto Day 17 after discharge)|Safety population included all participants who received at least 1 minute of study drug infusion (pre-amendment and post-amendment).||participants|||Number
644636|NCT02204579|Primary|Number of Participants With Clinically Significant Vital Signs and Electrocardiogram (ECG) Abnormalities||From Day 1 up to safety follow-up assessment (upto Day 17 after discharge)|Safety population included all participants who received at least 1 minute of study drug infusion (both pre-amendment and post-amendment participants).||participants|||Number
644637|NCT02204579|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)||From Day 1 up to safety follow-up assessment (upto Day 17 after discharge)|Safety population included all participants who received at least 1 minute of study drug infusion (pre-amendment and post-amendment).||participants|||Number
644638|NCT02204449|Other Pre-specified|Cardiac Rehabilitation Enrollment in Site Closer to Home|A blinded research assistant will call those patients who were re-referred to a cardiac rehabilitation site closer to their home to see if they enrolled in cardiac rehabilitation. The study coordinator will then compare this to enrollment rates (already determined by the blinded research assistant) of those who enrolled in the program at the hospital system in which they were inpatients.|8 weeks after patient is discharged from hospital|||participants|||Number
644639|NCT02204449|Secondary|Cardiac Rehabilitation Referral|A blinded research assistant will examine patient medical records to determine if patients were referred to cardiac rehabilitation.|12 weeks after patient has been discharged from hospital|||participants|||Number
644640|NCT02204449|Primary|Cardiac Rehabilitation Enrollment|A blinded research assistant will either examine medical records or call the participant (i.e., patient) at home to determine if they have enrolled in cardiac rehabilitation.|12 weeks after patient is discharged from hospital|||participants|||Number
644641|NCT02204410|Primary|Clinical Global Impression (CGI) Improvement for Deficient Emotional Self-Regulation (DESR)|"The Clinical Global Impression (CGI) is a clinician rated measure of illness severity, improvement, and efficacy of treatment (collected at all study visits). We examined the CGI Improvement specifically. The CGI Improvement for Deficient Emotional Self-Regulation (DESR) was reported at baseline and completion. The CGI-I is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. It is rated as:
Very much improved
Much improved
Minimally improved
No change
Minimally worse
Much worse
Very much worse"|Baseline and 12 Weeks|Ten participants completed at least 6 weeks of the 12 week trial. These 10 participants were included in the analysis.||units on a scale||Standard Deviation|Mean
644642|NCT02204410|Primary|Emotional Control Subscale of the Behavior Rating Inventory of Executive Function - Parent Form (BRIEF-Parent)|"The Behavior Rating Inventory of Executive Function - Parent Form (BRIEF-Parent) is a 75-item checklist with a large normative sample, internal consistency, test-retest reliability, inter-rater reliability, and external and concurrent validity, divided into nine empirically and theoretically derived and T-scored subscales. The Emotional Control subscale measures the impact of executive function problems on emotional expression and assesses a child's ability to modulate or control his or her emotional responses. It is a 10-item subscale, and each item is scored Never, Sometimes, or Often. Raw scores for all scales are computed with Software Portfolio (BRIEF-SP), which provides a raw score and T score (based on child's age) for each scale. Higher scores represent more greater emotional dysregulation."|Baseline and 12 Weeks|Ten participants completed at least 6 weeks of the 12 week trial. These 10 participants were included in the analysis.||units on a scale||Standard Deviation|Mean
644643|NCT02204371|Secondary|PK/PD Modeling Analysis to Characterize the Relationship Between Pazopanib Trough Concentrations and Epistaxis Frequency and Duration/Severity|A repeated categorical event per time interval PK/PD modeling analysis was planned (data permitting) to characterize the relationship between pazopanib trough concentrations and epistaxis frequency and duration/severity. Due to the small sample size and the fact that only one dose was studied these analyses were not performed.|Weeks 3, 6, 9 and 12|Pharmacokinetic/Pharmacodynamic Population|||||
644644|NCT02204371|Secondary|Graphical Exploration of PK/Pharmacodynamic (PD) Relationships Between Pazopanib Exposure and Selected PD|Graphical exploration of PK/PD relationships between pazopanib exposure and selected parameters was to be explored if data permitted. Due to the small sample size and the fact that only one dose was studied these analyses were not performed.|Weeks 3, 6, 9 and 12|Pharmacokinetic/Pharmacodynamic Population|||||
644645|NCT02204371|Secondary|Plasma Concentration of GW786034 at the Indicated Time Points|Predose (trough) blood samples were collected at weeks 3, 6, 9, and 12. Blood samples for pharmacokinetic (PK) profile were collected at pre-dose, 1, 2, 3, 4, 6 and 8 hours post dose. Area under the curve (0-tau), Concentration tau (Ctau), and maximum concentration (Cmax) following repeat administration was to be studied if data permitted.|Weeks 3, 6, 9 and 12|Pharmacokinetic Population: The Pharmacokinetic Population includes participants who had a pharmacokinetic sample obtained and analyzed. Only those par. available at the indicated time points were analyzed (specified by n=X in the category titles).||µg/mL||Standard Deviation|Mean
644646|NCT02204371|Secondary|Number of Participants With Any Adverse Events (AE) or Serious Adverse Event (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.|From start of investigational product (IP) through the Study Phase (12 weeks post-dose) (assessed up to 28 weeks)|Safety Population||Participants|||Number
648280|NCT02107014|Primary|Change in IL-7 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].|||pg/mL||95% Confidence Interval|Median
644648|NCT02204371|Secondary|Number of Participants With Electrocardiogram (ECG) Data Meeting Criteria of Potential Clinical Concern|The following ECG parameters were analyzed: PR, QRS, QT, corrected QT [QTc] intervals. Criteria for clinical concern:. QT where value is > 450, QT[QTc] where value is > 450, PR where value is < 110 or > 220, QRS where value is < 75 or >110.|Up to Week 16|Safety population||Participants|||Number
644649|NCT02204371|Secondary|Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern|The following laboratory parameters were analyzed in supine position after 10 minutes rest: Diastolic blood pressure (DBP), Systolic blood pressure (SBP) and Heart rate (HR). Values above upper limit of normal and below lower limit to normal have been presented as high and low respectively.|Up to Week 16|Safety Population||Participants|||Number
644650|NCT02204371|Secondary|Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern|The following laboratory parameters were analyzed: hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, lymphocytes; alanine amino transferase (ALT), alkaline phosphatase (ALP), aspartate amino transferase (AST), gamma glutamyl transferase (GGT), total bilirubin, albumin, total protein, blood urea nitrogen, creatinine, uric acid, sodium, potassium, chloride, calcium, total carbondioxide, glucose, magnesium, and ferritin. Only those parameters for which at least one value of clinical concern are reported in the table. Values above upper limit of normal and below lower limit to normal have been presented as high and low respectively.|Up to Week 16|Safety Population: The Safety Population comprises of all participants who received at least one dose of study treatment. This population is based on the treatment the participant actually received.||Participants|||Number
644651|NCT02204371|Secondary|Overall Health-related (HR) Quality of Life (QOL) Score Measured Using SF-36v2 at Day 1, Week 6 and Week 12|SF-36v2 is a generic HR QOL instrument with 36 items covering 8 subscales (SS) clustering into 2 global scores, the physical component summary score (PCS: physical functioning (PF), role physical (RP), bodily pain (BP), and general health (GH)) and mental component summary score (MCS: vitality (VT), social functioning (SF), role emotional (RE) and mental health (MH)). All scores are normalized so that mean score for a representative US population = 50, with a standard deviation = 10. Information was used to observe a direction in overall QOL. Ranges are shown below. Higher scores represent better QOL and minimum important differences are PF, 3; RP, 3; BP, 3; GH, 2; VT, 2; SF, 3; RE, 4; and MH, 3 PCS, 2; MCS, 3. Response Consistency Index (RCI) measures the consistency of responses to individual survey responses. Lower the score the more consistent the individual responses. SF-6D Health Utility Index (HUI) Score = 0 (worst measured health state) to 1 (best measured health state).|Day (D) 1, Week (W) 6 and Week 12|Pharmacodynamic Population. Only those par. available at the indicated time points were analyzed (specified by n=X in the category titles).||Scores on a scale||Standard Deviation|Mean
644652|NCT02204371|Secondary|Change From Baseline in Ferritin at the Indicated Time Points|Only pre-infusion ferritin values have been included in the analyses. All ferritin measurements that fall within 5 days of iron infusion date are considered post-infusion. Baseline ferritin value is defined as the average of the last two measurements during the run-in period. Average of the last two measurements during the run-in period was calculated as sum of the last 2 measured values of ferritin divided by 2. Change from Baseline is calculated as the difference between the Post dose value at indicated visit minus Baseline value. Par. were evaluated at baseline, treatment period (Weeks 1.5, 3, 4.5, 6, 7.5, 9, 10.5 and 12) and follow-up period (16, 20, 24 and 28).|Baseline, Week 1.5, Week 3, Week 4.5, Week 6, Week 7.5, Week 9, Week 10.5, Week 12, Week 16, Week 20, Week 24 and Week 28|Pharmacodynamic Population. Only those par. available at the indicated time points were analyzed (specified by n=X in the category titles).||µg per L||Standard Deviation|Mean
644653|NCT02204371|Secondary|Change From Baseline in the Average of the Last 3 Ferritin Measures in the Dosing Period (Week 9, Week 10.5 and Week 12)|For post-Baseline ferritin assessments, average of the last 3 measurements of the dosing period (Weeks 9, 10.5 and 12) was computed. Only pre-infusion ferritin values have been included in the analyses. Baseline ferritin value is the average of the last two measurements during the run-in period. Average of the last two measurements during the run-in period was calculated as sum of the last 2 measured values of ferritin divided by 2. Change from Baseline was calculated as the average of the last 3 measured values of ferritin minus the Baseline value. Average of the last 3 measurements was calculated as sum of the last 3 measured values of ferritin divided by 3. If measurements were missing at one or two of the 3 visits at Weeks 9, 10.5 and 12, then the average was based on the available measurements.|Baseline, Week 9, Week 10.5 and Week 12|Pharmacodynamic Population. Only those par. available at the indicated time points were analyzed.||micrograms per liter (µg per L)||Standard Deviation|Mean
644654|NCT02204371|Primary|Total Units of Packed Red Blood Cells (PRBCs) Transfused During the Entire Dosing and Follow-up Period by 4 Week Interval|Baseline PRBC transfused is defined as the number of units of PRBC transfused during the last 4 weeks of run-in period (i.e., Day -28 to Day -1). Total units of PRBCs transfused during the entire dosing and follow-up period was listed by 4 week interval. Individual participant data been reported.|Over the last 4 weeks of run-in and at 4 week intervals during dosing and follow-up|Pharmacodynamic Population||Number of units|||Number
644655|NCT02204371|Primary|Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval|Total iron intake at Baseline is defined as the sum total of iron intake (oral + intravenous infusion) during the last 4 weeks of run-in period (i.e., Day -28 to Day -1). Total iron intake over the entire dosing and follow-up period was listed by 4 week interval. Individual participant data has been reported.|Last 4 weeks of run-in and during last 4 weeks of dosing period|Pharmacodynamic Population||Milligram|||Number
644656|NCT02204371|Primary|Total Iron Intake Over the Last 4 Weeks of the Dosing Period|Total iron intake at Baseline is defined as the sum total of iron intake (oral + intravenous infusion) during the last 4 weeks of run-in period (i.e., Day -28 to Day -1). Total iron intake over the last 4 weeks of run-in and during last 4 weeks of dosing period was listed. Individual participant data has been reported.|Last 4 weeks of run-in and during last 4 weeks of dosing period|Pharmacodynamic Population||Milligram|||Number
644657|NCT02204371|Primary|Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)|Intensity of epistaxis based on daily diaries has been reported as total gushing and total non gushing from Baseline, On-Therapy (OT) to Follow-up (F). Individual participant data from the daily diaries has been reported.|Over last 2 weeks of the run-in phase and then 2 week intervals throughout treatment period and follow-up period (from daily diaries)|Pharmacodynamic Population||Number of gushing/non-gushing nosebleeds|||Number
644658|NCT02204371|Primary|Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)|Frequency of epistaxis based on daily diaries has been reported over Baseline, On-Therapy (OT) to Follow-up (F). Individual participant data from the daily diaries has been reported.|Over last 2 weeks of the run-in phase and then 2 week intervals throughout treatment period and follow-up period (from daily diaries)|Pharmacodynamic Population||Number of nosebleeds|||Number
644659|NCT02204371|Primary|Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)|Duration of epistaxis based on daily diaries has been reported over Baseline, On-Therapy (OT) to Follow-up (F). Individual participant data from the daily diaries has been reported.|Over last 2 weeks of the run-in phase and then 2 week intervals throughout treatment period and follow-up period (from daily diaries)|Pharmacodynamic Population||Minutes|||Number
644660|NCT02204371|Primary|Change From Baseline in Hemoglobin at the Indicated Time Points|Only pre-transfusion hemoglobin values have been included in the analyses. All hemoglobin values that fall within 5 days of packed red blood cells (PRBC) transfusion are considered as post-transfusion values. Baseline hemoglobin value is defined as the average of the last two measurements during the run-in period. Average of the last two measurements during the run-in period was calculated as sum of the last 2 measured values of hemoglobin divided by 2. Change from Baseline was calculated as the Post dose value at the indicated visit minus the Baseline value. Par. were evaluated at Treatment period (Weeks 1.5, 3, 4.5, 6, 7.5, 9, 10.5 and 12) and Follow-up period (Weeks 16, 20, 24 and 28).|Baseline, Week 1.5, Week 3, Week 4.5, Week 6, Week 7.5, Week 9, Week 10.5, Week 12, Week 16, Week 20, Week 24 and Week 28|Pharmacodynamic Population. Only those par. available at the indicated time points were analyzed (specified by n=X in the category titles).||g/L||Standard Deviation|Mean
644661|NCT02204371|Primary|Change From Baseline in the Average of the Last 3 Hemoglobin Measures in the Dosing Period (Week 9, Week 10.5 and Week 12)|For post-Baseline hemoglobin assessments, average of the last 3 measurements of the dosing period (Weeks 9, 10.5 and 12) was computed. Only pre-transfusion hemoglobin values have been included in the analyses. Baseline hemoglobin value is the average of the last two measurements during the run-in period. . Average of the last two measurements during the run-in period was calculated as sum of the last 2 measured values of hemoglobin divided by 2. Change from Baseline was calculated as the average of the last 3 measured values of hemoglobin minus the Baseline value. Average of the last 3 measurements was calculated as sum of the last 3 measured values of hemoglobin divided by 3. If measurements were missing at one or two of the 3 visits at Weeks 9, 10.5 and 12, then the average was based on the available measurements.|Baseline, Week 9, Week 10.5 and Week 12|Pharmacodynamic Population. Only those par. available at the indicated time points were analyzed.||Grams per liter (g/L)||Standard Deviation|Mean
644662|NCT02204371|Primary|Change From Baseline in Epistaxis Severity Score at the Indicated Time Points|The Epistaxis (nose bleeding) severity score (ESS) is a 6-item par-reported outcome measure designed to be a uniform epistaxis severity scoring system to assess the effectiveness of specific treatments on HHT-related epistaxis. Four questions document epistaxis frequency, duration, intensity and need for treatment, whereas two additional questions detail the presence of anemia and if a par has required a blood transfusion as a consequence of their epistaxis. Questions are variably weighted and results are tabulated on a 0-10 scale (0=no disease, 10 = severe disease). The minimum important difference is 0.71. Baseline is the Day1 pre-dose assessment value. Change from Baseline is calculated as the Post dose value at the indicated visit minus the Baseline value. Par were evaluated at Baseline, Treatment period (Weeks 6 and 12) and Follow-up period (Weeks 16, 20, 24 and 28). Only those par available at the indicated timepoints were analysed (specified by n=X in the category titles).|Baseline, Week 6, Week 12, Week 16, Week 20, Week 24 and Week 28|Pharmacodynamic Population: All par. who received at least one dose of study treatment (Safety Population) and who also provided data from at least one pharmacodynamic assessment (hemoglobin, ferritin, epistaxis daily diary).||Scores on a scale||Standard Deviation|Mean
644663|NCT02204319|Other Pre-specified|Change in the Vulvar Pain Functional Scale Questionnaire|"Questionnaire of eleven questions involving specific functions that may impart pain in the vulvar region and patient response to present tolerance level. Questions have 4-5 answer choices weighted on a 0-3 scale of impairment, with 3 being worst.
Worst reported score of functional impact =33. No functional impact = 0"|Baseline, and after last treatment visit at Week 8|women average age of 26 +/- 5.533 Years with appropriate diagnoses||percent change||Standard Deviation|Mean
644664|NCT02204319|Secondary|Change in Patient Specific Functional Scale Questionnaire|Questionnaire that measures on a 0-10 scale (0= No function, and 10= normal function) one function that most impacts the patient's present symptoms (vaginal penetration/intercourse chosen as most important and pertinent) Measured amount of point change on the scale.|Baseline, and two weeks following last treatment at Week 8|women average 26+/- 5.533 Years of age who were not pregnant with appropriate diagnoses||units on a scale||Standard Deviation|Mean
644665|NCT02204319|Primary|Percent Improvement Change in Visual Analogue Pain Scale (VAS) Calculated With Q-tip Palpation Over 6 Sites From Baseline Visit to Follow up at Two Week From Last Visit|"III. Q-tip testing:
. Q-tip pressure will be applied at the following areas, in the exact order listed: 2:00, 10:00, 5:00, 7:00, 12:00, and 6:00. An average VAS report of pain taken overall and compared from first baseline visit to end of study re-assessment two weeks following last treatment.
• Pain intensity marked an a line with a point between 0-100 on the Visual Analogue Scale (VAS). A separate rating is recorded for each of the 6 numbered areas (see box 1 for reference). 100 is maximum pain level and 0 is no pain measured in centimeters per FDA guidelines for pain calculation on the VAS"|Average of all sites Compared from baseline visit and at 8 week (from start) follow up|||percent change from first to last Rx||Standard Deviation|Mean
644666|NCT02204007|Secondary|Operative Time|Duration of the surgical case|time of surgery|||minutes||Full Range|Mean
644667|NCT02204007|Primary|Acetabular Shell Version and Inclination|A CT scan of all patients will be obtained within 2 weeks of surgery to measure placement (acetabular version & inclination measured in degrees) of the acetabular shell|within 2 weeks of surgery|||degrees||Full Range|Mean
644849|NCT02198040|Primary|Changes in Biceps Strength|Measured by the breaking test for patients with haemophilia with a score from 0 to 5 (where 0 indicates normal strength and 5 is the absence of muscle contraction).|Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)|It has made an analysis by intention to treat with the 27 patients included in the study||points||Standard Deviation|Mean
644668|NCT02203916|Secondary|Percentage of Participants Who Achieved Both a Clinic DBP and SBP Response at Week 6|Percentage of participants who achieved both a clinic DBP and SBP response measured at week 6 defined as clinic DBP <90 mmHg and/or reduction of ≥10 mmHg from Baseline AND clinic SBP <140 mmHg and/or reduction of ≥20 mmHg from Baseline. DBP and SBP are based on the arithmetic mean of 3 serial blood pressure measurements.|Baseline and Week 6|Participants from the FAS, including all randomized participants, who received at least 1 dose of double-blind study drug, with both a Baseline value and at least 1 post-baseline value, who were randomized only once. Missing values were imputed using last observation carried forward (LOCF).||percentage of participants|||Number
644669|NCT02203916|Secondary|Percentage of Participants Who Achieved a Clinic SBP Response at Week 6|SBP response is defined as clinic SBP <140 mmHg and/or reduction of ≥20 mmHg from Baseline. SBP is the arithmetic mean of 3 serial systolic blood pressure measurements.|Baseline and Week 6|Participants from the FAS, including all randomized participants, who received at least 1 dose of double-blind study drug, with both a Baseline value and at least 1 post-baseline value, who were randomized only once. Missing values were imputed using last observation carried forward (LOCF).||percentage of participants|||Number
644670|NCT02203916|Secondary|Percentage of Participants Who Achieved a Clinic DBP Response at Week 6|Clinic DBP response is defined as clinic DBP <90 mmHg and/or reduction of ≥10 mmHg from Baseline. DBP is the arithmetic mean of 3 serial diastolic blood pressure measurements.|Baseline and Week 6|Participants from the FAS, including all randomized participants, who received at least 1 dose of double-blind study drug, with both a Baseline value and at least 1 post-baseline value, who were randomized only once. Missing values were imputed using last observation carried forward (LOCF).||percentage of participants|||Number
644671|NCT02203916|Secondary|Change From Baseline to Week 6 in Trough Clinic Sitting Diastolic Blood Pressure (DBP)|The change in trough clinic sitting diastolic blood pressure measured at week 6 relative to baseline. The trough is the average of the non-missing values of 3 serial trough sitting diastolic blood pressure measurements. Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 6 blood pressure was measured approximately 24 hours after the previous day's dose. An analysis of covariance (ANCOVA) model, with treatment group as a fixed effect and Baseline sitting clinic diastolic blood pressure as a covariate was used for analysis.|Baseline and Week 6|Participants from the FAS, including all randomized participants, who received at least 1 dose of double-blind study drug, with both a Baseline value and at least 1 post-baseline value, who were randomized only once. Missing values were imputed using last observation carried forward (LOCF).||mmHg||Standard Deviation|Mean
644672|NCT02203916|Primary|Change From Baseline to Week 6 in Trough Clinic Sitting Systolic Blood Pressure (SBP)|The change in trough clinic sitting systolic blood pressure measured at week 6 relative to baseline. The trough is the average of the non-missing values of 3 serial trough sitting systolic blood pressure measurements. Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 6 blood pressure was measured approximately 24 hours after the previous day's dose. An analysis of covariance (ANCOVA) model, with treatment group as a fixed effect and Baseline sitting clinic systolic blood pressure as a covariate was used for analysis.|Baseline and Week 6|Participants from the Full Analysis Set (FAS), including all randomized participants, who received at least 1 dose of double-blind study drug, with both a Baseline value and at least 1 post-baseline value, who were randomized only once. Missing values were imputed using last observation carried forward (LOCF).||mmHg||Standard Error|Least Squares Mean
644673|NCT02203786|Secondary|Winnings on Slot Machine Upon Completion of Game|Credits|15-minutes|||credits||Standard Deviation|Mean
644674|NCT02203786|Secondary|Speed of Play on Slot Machine Game|Number of individual spins in a 15-minute slot machine game. Each spin corresponds to one wager.|15-minutes|||individual spins/15-minutes||Standard Deviation|Mean
644675|NCT02203786|Secondary|Betting Behaviour in Laboratory-based Slot Machine Game|Risk taking was operationally defined as credits wagered per spin (mean computed for total spins)|1x per test session (total of 4 test sessions) for duration of the study: 4 weeks (1 session/week)|||credits/spin on slot machine||Standard Deviation|Mean
644676|NCT02203786|Secondary|Cognitive Task Performance|Response time to words (gambling, alcohol, positive affect, negative affect) as a percentage of neutral categorized words (parts of a building). This provides an index of the relative salience of stimuli from these four categories against a baseline of reaction to words with no clinical relevance or emotional valence. Smaller scores indicate faster relative response time to the test stimuli vs. neutral stimuli (i.e., greater salience)|At key points during testing: immediately after the slot machine, at expected peak subjective-behavioral effects for amphetamine (90-minutes post-capsule administration)|||percentage of neutral categorized words||Standard Deviation|Mean
644677|NCT02203786|Secondary|Diastolic Blood Pressure (DBP)|Measure changes from baseline, especially physiologic reactivity to the slot machine and amphetamine.|At key points in testing: immediately after the slot machine game (change from session baseline), and at expected peak subjective-behavioral effects for amphetamine (90-minutes post-capsule administration)(change from session baseline).|||mm Hg||Standard Deviation|Mean
644678|NCT02203786|Primary|Subjective Reinforcement Self-report Scales|Self-reported Confidence to Refrain from Gambling (0 - 10) was assessed at test session baseline, before the slot machine and after the slot machine (Phase 1); and before amphetamine and at peak amphetamine (Phase 2). The maximum score (10) denotes complete confidence to refrain from gambling (i.e., NO urge or compulsion to gamble); the minimum score (0) denotes complete lack of confidence to refrain from gambling (i.e., overwhelming urge to gamble). Scores between 10 and 0 denote intermediate confidence to refrain from gambling with LOWER scores denoting less confidence to refrain from gambling -- i.e., GREATER urge or compulsive motivation to gamble. Scores shown are based on single item visual analogue ratings 0-10 from each participant at the specified time point. The mean (SD) of these single item ratings is presented for each sub-group.|At key points in testing: immediately after the slot machine game, and at expected peak subjective-behavioral effects for amphetamine (90-minutes post-capsule administration).|||units on a scale||Standard Deviation|Mean
644897|NCT02196714|Secondary|Change in PR Interval From Pre-dose to 12 Hours Post Dose|Change in PR Interval from Pre-dose to 12 hours Post dose|12 hours|Safety Population||msec||Full Range|Mean
644898|NCT02196714|Secondary|Change in Heart Rate From Pre-dose to 12 Hours Post Dose|Change in Heart Rate from Pre-dose to 12 hours Post dose|12 hours|Safety Population||Beats/Min||Full Range|Mean
644679|NCT02203747|Primary|Visual Distortion Symptoms|"Subjective rating of visual distortion symptoms under overall conditions at baseline. Rating scale consisted of the following categories: did not experience (rating = 0), mild (rating = 1), moderate (rating = 2), or severe (rating = 3), therefore, the lower values represent the best outcome. The minimum score was 0 and the maximum score was 3."|1 week|"Of the 45 subjects in the Pseudophakic implanted with toric IOL group, one (#307) was excluded due to a protocol deviation (subject visit was completed outside of the protocol-defined visit interval)."||rating of visual distortion symptoms||Standard Deviation|Mean
644680|NCT02203747|Primary|Visual Distortion Symptoms|"Subjective rating of visual distortion symptoms under overall conditions at baseline. Rating scale consisted of the following categories: did not experience (rating = 0), mild (rating = 1), moderate (rating = 2), or severe (rating = 3), therefore, the lower values represent the best outcome. The minimum score was 0 and the maximum score was 3."|Baseline|"Of the 45 subjects in the Pseudophakic implanted with toric IOL group, one (#102) was excluded due to a protocol deviation (improper method used to simulate visual distortion)."||rating of visual distortion symptoms||Standard Deviation|Mean
644681|NCT02203721|Primary|Uncorrected Intermediate Visual Acuity|Uncorrected Intermediate Visual Acuity at 6 months.|6 months|Intent to Treat population||LogMAR||Standard Error|Mean
644682|NCT02203721|Primary|Distance Corrected Intermediate Visual Acuity|FDA has requested co-primary endpoints of distance corrected and uncorrected intermediate visual acuity.|At 6 months|Intent to Treat Population||LogMAR||Standard Error|Mean
644683|NCT02203578|Secondary|T Cell Kinetics - Reconstitution||Up to 12 months after initiation of romidepsin|Study was terminated early due to slow accrual and insufficient data was collected to assess this outcome measure.|||||
644684|NCT02203578|Secondary|Rate of Documented Infection||Up to 12 months after initiation of romidepsin|Study was terminated early due to slow accrual and insufficient data was collected to assess this outcome measure.|||||
644685|NCT02203578|Secondary|Total Duration of Immunosuppressive Therapy||Up to 12 months after initiation of romidepsin|Study was terminated early due to slow accrual and insufficient data was collected to assess this outcome measure.|||||
644686|NCT02203578|Primary|Incidence of cGVHD||At 12 months after initiation of romidepsin|Study was terminated early due to slow accrual and insufficient data was collected to assess this outcome measure.|||||
644687|NCT02203578|Primary|Incidence of cGVHD||At 9 months after initiation of romidepsin|Study was terminated early due to slow accrual and insufficient data was collected to assess this outcome measure.|||||
644688|NCT02203578|Primary|Incidence of cGVHD||At 6 months after initiation of romidepsin|Study was terminated early due to slow accrual and insufficient data was collected to assess this outcome measure.|||||
644689|NCT02203578|Primary|Incidence of cGVHD||At 3 months after initiation of romidepsin|Study was terminated early due to slow accrual and insufficient data was collected to assess this outcome measure.|||||
644690|NCT02203578|Primary|Incidence of cGVHD||At 1 month after initiation of romidepsin|Study was terminated early due to slow accrual and insufficient data was collected to assess this outcome measure.|||||
644691|NCT02203578|Primary|Incidence of aGVHD||At 28 days after initiation of romidepsin|Study was terminated early due to slow accrual and insufficient data was collected to assess this outcome measure.|||||
644692|NCT02203565|Primary|Percent of Women Who Develop Grade 3 or 4 Radiation Dermatitis (as Defined by the Stanford Radiation Dermatitis Scoring System) During a Course of Radiation Therapy|"Stanford Radiation Dermatitis Scoring System:
Grade Clinical finding
0 No skin change
1 Faint, barely detectable erythema 2 Follicular rash, hyperpigmentation, evolving erythema 3 Dry desquamation, brisk erythema 4 Moist desquamation 5 Bleeding, ulceration, and/or infection"|Baseline to up to 6 weeks after completion of therapy|Patients with complete data for analysis. While 20 patients were enrolled in the study, only 14 had data available for analysis.||Participants|||Count of Participants
644693|NCT02203162|Primary|Change in Cough Reflex Sensitivity (Log C5)|Measurement of cough reflex sensitivity to capsaicin (C5) performed 15 minutes and 24 hours after electronic cigarette use session. Changes in cough reflex sensitivity 15 minutes after e-cig use compared to baseline will be assessed. In addition, cough reflex sensitivity 24 hours after e-cig exposure will also be measured, so that duration of any changes noted after 15 minutes can be assessed. Increase in C5 means decrease in cough reflex sensitivity. Capsaicin cough challenge involves subjects breathing in incremental doubling concentrations of aerosolized capsaicin, 1 minute apart, until the concentration of capsaicin (micromolar) inducing 5 or more coughs (C5) is reached.|Baseline, 15 minutes, and 24 hours post-exposure to e-cig.|||log C5||95% Confidence Interval|Mean
644694|NCT02203149|Secondary|Part 2: Percentage of Participants Achieving HCV RNA <LLoQ Over Time After Active Treatment|Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® Taqman quantitative RT-PCR assay, v2.0, which had a LLoQ of 1.2 Log IU/mL (15 IU/mL) and a LLoD below 15 IU/ml (no specific value). Undetectable HCV RNA was defined as HCV RNA target not detected. The percentage of participants with HCV RNA <LLoQ at TW2, TW4, TW12, EOT, FUWK4, FUWK12, and FUWK24 is summarized for each arm. Data reported for the Part 2 Deferred Treatment Arm corresponds to the deferred active treatment weeks and subsequent follow-up. The Clopper-Pearson method was used to construct 95% CIs for SVR rates.|Part 2: Active TW2, TW4, TW12, End of Treatment (EOT), FUWK4, FUWK12, FUWK24|All randomized participants in Part 2 who have received ≥1 dose of active study treatment and who have any follow-up efficacy measurement. Data for participants in Part 1 were analyzed and reported separately.||percentage of participants||95% Confidence Interval|Number
644695|NCT02203149|Secondary|Part 2: Percentage of Participants Achieving Undetectable HCV RNA Over Time After Active Treatment|Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® Taqman quantitative RT-PCR assay, v2.0, which had a LLoQ of 1.2 Log IU/mL (15 IU/mL) and a LLoD below 15 IU/ml (no specific value). Undetectable HCV RNA was defined as HCV RNA target not detected. The percentage of participants with undetectable HCV RNA at TW2, TW4, TW12, EOT, FUWK4, FUWK12, and FUWK24 is summarized for each arm. Data reported for the Part 2 Deferred Treatment Arm corresponds to the deferred active treatment weeks and subsequent follow-up. The Clopper-Pearson method was used to construct 95% CIs for SVR rates.|Part 2: Active TW2, TW4, TW12, End of Treatment (EOT), FUWK4, FUWK12, FUWK24|All randomized participants in Part 2 who have received ≥1 dose of active study treatment and who have any follow-up efficacy measurement. Data for participants in Part 1 were analyzed and reported separately.||percentage of participants||95% Confidence Interval|Number
644696|NCT02203149|Primary|Part 2: Percentage of Participants That Discontinued Initial Treatment Due to an AE|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor’s product, was also an AE. The primary safety evaluation was limited to the initial treatment period and first 4 follow-up weeks, and the primary safety statistical analysis compared the percentage of participants with events between the Part 2 Immediate Treatment Arm and the Part 2 Deferred Treatment Arm while receiving placebo.|Up to Study Week 12 in Part 2|All randomized participants in Part 2 who received ≥1 dose of study treatment and had any safety follow-up data. Participants in the Deferred Arm would have received only placebo treatment up to Study Week 12. Data for participants in Part 1 were analyzed and reported separately.||percentage of participants|||Number
644697|NCT02203149|Primary|Part 2: Percentage of Participants Experiencing an AE During Initial Treatment and First 4 Follow-Up Weeks|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor’s product, was also an AE. The primary safety evaluation was limited to the initial treatment period and first 4 follow-up weeks, and the primary safety statistical analysis compared the percentage of participants with events between the Part 2 Immediate Treatment Arm and the Part 2 Deferred Treatment Arm while receiving placebo.|Up to 4 weeks following initial treatment in Part 2 (Up to total of 16 weeks)|All randomized participants in Part 2 who received ≥1 dose of study treatment and had any safety follow-up data. Participants in the Deferred Arm would have received only placebo treatment up to Study Week 16. Data for participants in Part 1 were analyzed and reported separately.||percentage of participants|||Number
644698|NCT02203149|Secondary|Part 1: Percentage of Participants Achieving HCV RNA Below the Lower Limit of Quantitation (<LLoQ) Over Time|Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® Taqman quantitative RT-PCR assay, v2.0, which had a LLoQ of 1.2 Log IU/mL (15 IU/mL) and a LLoD below 15 IU/ml (no specific value). Undetectable HCV RNA was defined as HCV RNA target not detected. The percentage of participants with HCV RNA <LLoQ at TW2, TW4, TW12, EOT, FUWK4, FUWK12, and FUWK24 is summarized for each arm. The Clopper-Pearson method was used to construct 95% CIs for SVR rates.|Part 1 TW2, TW4, TW12, EOT, FUWK4, FUWK12, FUWK24|All randomized participants in Part 1 who have received ≥1 dose of study treatment and who have any follow-up efficacy measurement. Data for participants in Part 2 were analyzed and reported separately.||percentage of participants||95% Confidence Interval|Number
644699|NCT02203149|Secondary|Part 1: Percentage of Participants Achieving Undetectable HCV RNA Over Time|Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® Taqman quantitative RT-PCR assay, v2.0, which had a LLoQ of 1.2 Log IU/mL (15 IU/mL) and a LLoD below 15 IU/ml (no specific value). Undetectable HCV RNA was defined as HCV RNA target not detected. The percentage of participants with undetectable HCV RNA at TW2, TW4, TW12, EOT, FUWK4, FUWK12, and FUWK24 is summarized for each arm. The Clopper-Pearson method was used to construct 95% CIs for SVR rates.|Part 1 Treatment Weeks (TW)2, TW4, TW12, End of Treatment (EOT), FUWK4, FUWK12, FUWK24|All randomized participants in Part 1 who have received ≥1 dose of study treatment and who have any follow-up efficacy measurement. Data for participants in Part 2 were analyzed and reported separately.||percentage of participants||95% Confidence Interval|Number
644700|NCT02203149|Primary|Part 1: Percentage of Participants That Discontinued Treatment Due to an AE|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, was also an AE. The primary safety evaluation was limited to the initial treatment period through FUWK4.|Up to Study Week 12 in Part 1|All randomized participants in Part 1 who received ≥1 dose of study treatment and had any safety follow-up data. Data for participants in Part 2 were analyzed and reported separately.||percentage of participants|||Number
644701|NCT02203149|Primary|Part 1: Percentage of Participants Experiencing an Adverse Event (AE) During Treatment and First 4 Follow-Up Weeks|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, was also an AE. The primary safety evaluation was limited to the initial treatment period through Follow-up Week 4 (FUWK4).|Up to 4 weeks post last dose in Part 1 (Up to total of 16 weeks)|All randomized participants in Part 1 who received ≥1 dose of study treatment and had any safety follow-up data. Data for participants in Part 2 were analyzed and reported separately.||percentage of participants|||Number
644711|NCT02202785|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An SAE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event.|From the first dose through 30 days after the last dose of study medication (Up to 7.9 months)|Safety population included all participants who received any amount of MLN0264.||Participants|||Number
644702|NCT02203149|Primary|Part 2: Percentage of Treatment-naïve Participants in the Immediate Treatment Arm Achieving Sustained Viral Response at 12 Weeks After The End of All Treatment (SVR12)|Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS® Taqman quantitative reverse transcription-polymerase chain reaction (RT-PCR) assay, v2.0, which had a lower limit of quantification (LLoQ) of 1.2 Log IU/mL (15 IU/mL) and a lower limit of detection (LLoD) below 15 IU/ml (no specific value). SVR12 was defined as undetectable HCV RNA (target not detected) at 12 weeks after the end of all study therapy. The Clopper-Pearson method was used to construct 95% confidence intervals (CIs) for the SVR12 rate. The lower limit of the 95% CI was compared to the reference rate of 75%; a lower CI limit that was higher than the reference rate would confirm the primary hypothesis and indicate that that the treatment combination was efficacious. As pre-specified in the protocol, only the Immediate Treatment Arm of Part 2 (treatment naïve participants) was included in the primary efficacy analysis.|12 weeks after end of all therapy in Part 2 (Study Week 24 of Part 2)|The primary efficacy analysis was assessed in all treatment-naïve participants randomized to the Part 2 Immediate Treatment Arm who received ≥1 dose of study treatment and had any follow-up efficacy measurement. No other arms were analyzed for this outcome measure.||percentage of participants||95% Confidence Interval|Number
644703|NCT02203032|Secondary|Percentage of Participants With an Investigator’s Global Assessment (IGA) Score of Cleared (0) or Minimal (1) and at Least a 2 Grade Improvement (From Week 16) at Week 28|The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants’ psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).|Week 28|Randomized population included all enrolled participants with IGA >=2 at Week 16 randomly assigned to 1 of the 2 treatment regimens (guselkumab or ustekinumab) at Week 16.||percentage of participants|||Number
644704|NCT02203032|Secondary|Number of Visits at Which Participants Achieved an IGA Score of Cleared (0) From Week 28 Through Week 40|The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants’ psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).|Week 28 through Week 40|Randomized population included all enrolled participants with IGA >=2 at Week 16 randomly assigned to 1 of the 2 treatment regimens (guselkumab or ustekinumab) at Week 16.||visits||Standard Deviation|Mean
644705|NCT02203032|Secondary|Number of Visits at Which Participants Achieved a Psoriasis Area and Severity Index (PASI) 90 Response From Week 28 Through Week 40|The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.|Week 28 through Week 40|Randomized population included all enrolled participants with IGA >=2 at Week 16 randomly assigned to 1 of the 2 treatment regimens (guselkumab or ustekinumab) at Week 16.||visits||Standard Deviation|Mean
644706|NCT02203032|Primary|Number of Visits at Which Participants Achieved an Investigator’s Global Assessment (IGA) Response of Cleared (0) or Minimal (1) and at Least a 2 Grade Improvement (From Week 16) From Week 28 Through Week 40|The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants’ psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).|Week 28 through Week 40|Randomized population included all enrolled participants with IGA >=2 at Week 16 randomly assigned to 1 of the 2 treatment regimens (guselkumab or ustekinumab) at Week 16.||visits||Standard Deviation|Mean
644707|NCT02202785|Secondary|Number of Participants With Antitherapeutic Antibodies (ATA)|Blood samples were collected to assess the immunogenicity of MLN0264 (ATA development) using a laboratory test. Neutralizing ATA assessment was performed for ATA-positive samples only.|Pre-dose of each 21 day cycle and 30 days after last dose of study medication (Up to 7.9 months)|Safety Population included all participant who received any amount of MLN0264.||Participants|||Number
644708|NCT02202785|Secondary|Percentage of Participants With Reduction From Baseline in Tumor Size|The percentage of participants with the best percentage of tumor reduction from baseline in the sum of the diameter was calculated|Day 21 of each 21-day cycle, 30 days after the last dose of study medication, and then every 12 weeks for up to an additional 6 months (Approximately 13.9 months)|Response-Evaluable Population was defined as all participants with measurable disease who receive at least 1 dose of MLN0264 and have at least 1 post-baseline response assessment.||percentage of participants|||Number
644709|NCT02202785|Secondary|Serum Concentration of Total Antibodies (Conjugated and Unconjugated)|Blood samples were collected and sent to a laboratory to be tested for conjugated and unconjugated antibodies.|Cycles 1-3 predose and 10 minutes, 4 hours, and 3, 4, 8 and 15 days postdose. Cycles 4+ predose, 10 minutes, 4 hours, and 4 and 8 days postdose.|"PK-Evaluable population included all participants who received at least 1 dose of MLN0264 and who have sufficient MLN0264 concentration−time data to permit reliable estimation of MLN0264 exposure.n in the categories is the number of participants with data available at the given time-point."||μg/mL||Standard Deviation|Mean
644710|NCT02202785|Secondary|MLN0264 Serum Concentrations|Blood samples were collected and sent to a laboratory to be tested for serum concentrations of MLN0264.|Cycles 1-3 predose and 10 minutes, 4 hours, and 3, 4, 8 and 15 days postdose. Cycles 4+ predose, 10 minutes, 4 hours, and 4 and 8 days postdose.|"Pharmacokinetic (PK)-Evaluable population included all participants who received at least 1 dose of MLN0264 and who have sufficient MLN0264 concentration−time data to permit reliable estimation of MLN0264 exposure. n in the categories is the number of participants with data available at the given time-point."||μg/mL||Standard Deviation|Mean
644712|NCT02202785|Secondary|Guanylyl Cyclase C (GCC) H-score Assessed by Immunohistochemistry (IHC)|GCC H-score is based on the sum of the 0 to 300 H-score for cytoplasmic staining and the 0 to 300 H-score for apical staining for a total possible H-score 0 to 600. Separate consent is required to obtain archival tumor specimens for GCC expression assessment prior to screening.|From pre-screening through end of study (approximately 18 months)|Safety population included all participants who received any amount of MLN0264.||scores on a scale||Full Range|Mean
644713|NCT02202785|Secondary|Serum Concentration of Monomethyl Auristatin E (MMAE)|Blood samples were collected and sent to a laboratory to be tested for MMAE.|Cycles 1-3 predose and 10 minutes, 4 hours, and 3, 4, 8 and 15 days postdose. Cycles 4+ predose, 10 minutes, 4 hours, and 4 and 8 days postdose.|"PK-Evaluable population included all participants who received at least 1 dose of MLN0264 and who have sufficient MLN0264 concentration−time data to permit reliable estimation of MLN0264 exposure. n in the categories is the number of participants with data available at the given time-point."||ng/mL||Standard Deviation|Mean
644714|NCT02202785|Secondary|Cmax: Maximum Observed Serum Concentration for MLN0264||Cycles 1-3 predose and 10 minutes, 4 hours, and 3, 4, 8 and 15 days postdose. Cycles 4+ predose, 10 minutes, 4 hours, and 4 and 8 days postdose.|Cmax was not a pre-specified secondary outcome measure. No data was collected.|||||
644715|NCT02202785|Secondary|Overall Survival (OS)|Overall survival is defined as the time in days from the date of first study drug administration to the date of death.|Until death or 6 months after the last patient completes treatment—whichever occurs first (Up to 16 months)|Safety population included all participants who received any amount of MLN0264.||days||Full Range|Median
644716|NCT02202785|Secondary|Disease Control Rate|Disease control rate is defined as the percentage of participants with complete response (CR) or partial response (PR) or stable disease (SD) with a minimum of 12 weeks' duration. Investigator response is based on the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. CR: Disappearance of all target lesions, non-target lesions, no new lesions, and normalization of tumor marker level. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesions. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum longest diameter (LD) since the treatment started.|Day 21 of every other 21-day cycle starting with Cycle 2, 30 days after the last dose of study medication, and then every 12 weeks for up to an additional 6 months (Up to 13.9 months)|Response-Evaluable population included all participants with measurable disease who received at least 1 dose of MLN0264 and had at least 1 post-baseline response assessment.||percentage of participants|||Number
644717|NCT02202785|Secondary|Duration of Response|Duration of response is defined as the time from the date of first documentation of a Partial Response or better to the date of first documentation of disease progression or relapse based on investigator assessment using RECIST version 1.1 guidelines. Per RECIST version 1.1 for target lesions and assessed by MRI: CR, Disappearance of all target lesions; PR, >=30% decrease in the sum of the longest diameter of target lesions.|From first documented response until disease progression (Up to 16 months)|Participants from the Response-Evaluable population, all participants with measurable disease who received at least 1 dose of MLN0264 and had at least 1 post-baseline response assessment, who had a response.||days||Full Range|Median
644718|NCT02202785|Secondary|Progression Free Survival (PFS)|PFS is defined as the time in days from the date of first study drug administration to the date of first documentation of disease progression or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Day 21 of every other 21-day cycle starting with Cycle 2, 30 days after the last dose of study medication, and then every 12 weeks for up to an additional 6 months (Up to 13.9 months)|Response-Evaluable population included all participants with measurable disease who received at least 1 dose of MLN0264 and had at least 1 post-baseline response assessment.||days||Full Range|Median
644719|NCT02202785|Secondary|Number of Participants With Potentially Clinically Significant Vital Signs Findings|Participants with at least one potentially clinically significant post-baseline vital sign finding including measurements of diastolic and systolic blood pressure, heart rate, and oral temperature.|Day 1 of each 21 day cycle and 30 days after the last dose of study medication (Up to 7.9 months)|Safety population included all participants who received any amount of MLN0264.||Participants|||Number
644720|NCT02202785|Secondary|Number of Participants With Potentially Clinically Significant Laboratory Evaluation Findings|Participants with at least one post-baseline potentially clinically significant serum chemistry, hematology, coagulation or urinalysis result. Clinically significant results are those that were assessed by the investigator to be Grade 3 or higher using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE). Grade 3=severe, Grade 4=life threatening or disabling and Grade 5=Death.|Day 1 of each 21 day cycle and 30 days after the last dose of study medication (Up to 7.9 months)|Safety population included all participants who received any amount of MLN0264.||Participants|||Number
644721|NCT02202785|Primary|Overall Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors (RECIST)|ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) as assessed by the investigator using Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR: Disappearance of all target lesions, non-target lesions, no new lesions, and normalization of tumor marker level. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesions.|Day 21, every other cycle, starting with Cycle 2 until disease progression, death or study closure (Up to 16 months)|Response-Evaluable population included all participants with measurable disease who received at least 1 dose of MLN0264 and had at least 1 post-baseline response assessment.||percentage of participants|||Number
644722|NCT02202759|Secondary|Number of Participants With Antitherapeutic Antibodies (ATA)|Blood samples were collected to assess the immunogenicity of MLN0264 (ATA development) using a laboratory test. Neutralizing ATA assessment was performed for ATA-positive samples only.|Pre-dose of each 21 day cycle and 30 days after last dose of study medication (Up to 10.7 months)|Safety Population included all participant who received any amount of MLN0264.||participants|||Number
644723|NCT02202759|Secondary|Guanylyl Cyclase C (GCC) H-score Assessed by Immunohistochemistry (IHC)|Analysis of GCC protein expression levels in tumor tissue (fresh biopsy pretreatment and whenever a biopsy is considered medically safe and technically feasible) was performed using a semiquantitative immunohistochemistry (IHC) assay and the total GCC H-Score was determined. GCC H-score is based on the sum of the 0 to 300 H-score for cytoplasmic staining and the 0 to 300 H-score for apical staining for a total possible H-score 0 to 600. Separate consent was required to obtain archival tumor specimens for GCC expression assessment prior to screening.|Approximately 20 months|Safety population included all participants who received any amount of MLN0264.||scores on a scale||Full Range|Mean
644724|NCT02202759|Secondary|Number of Participants With Reduction From Baseline in Tumor Size|The number of participants with the best percentage of tumor reduction from baseline in the sum of the diameter was calculated.|Day 21 of every other 21-day cycle starting with Cycle 2, 30 days after the last dose of study medication, and then every 12 weeks for up to an additional 6 months (Up to 16.7 months)|Response-Evaluable Population was defined as all participants with measurable disease who receive at least 1 dose of MLN0264 and have at least 1 postbaseline response assessment.||participants|||Number
644725|NCT02202759|Secondary|Serum Concentration of Monomethyl Auristatin E (MMAE)|Blood samples were collected and sent to a laboratory to be tested for MMAE.|Cycles 1-3 pre-dose and 10 minutes, 4 hours, and 3, 4, 8 and 15 days post-dose; Cycles 4-9 and 11-14 pre-dose and 10 minutes post-dose; End of Treatment.|"PK-Evaluable population included all participants who received at least 1 dose of MLN0264 and who had sufficient MLN0264 concentration−time data to permit reliable estimation of MLN0264 exposure. n in the categories is the number of participants with data available at the given time-point."||ng/mL||Standard Deviation|Mean
644726|NCT02202759|Secondary|Serum Concentration of Total Antibodies (Conjugated and Unconjugated)|Blood samples were collected and sent to a laboratory to be tested for conjugated and unconjugated antibodies.|Cycles 1-3 pre-dose and 10 minutes, 4 hours, and 3, 4, 8 and 15 days post-dose; Cycles 4-9 and 11-14 pre-dose and 10 minutes post-dose; End of Treatment.|"PK-Evaluable population included all participants who received at least 1 dose of MLN0264 and who had sufficient MLN0264 concentration−time data to permit reliable estimation of MLN0264 exposure. n in the categories is the number of participants with data available at the given time-point."||μg/mL||Standard Deviation|Mean
644727|NCT02202759|Secondary|MLN0264 Serum Concentrations|Blood samples were collected and sent to a laboratory to be tested for serum concentrations of MLN0264.|Cycles 1-3 pre-dose and 10 minutes, 4 hours, and 3, 4, 8 and 15 days post-dose; Cycles 4-9 and 11-14 pre-dose and 10 minutes post-dose; End of Treatment.|"Pharmacokinetic (PK)-Evaluable population included all participants who received at least 1 dose of MLN0264 and who had sufficient MLN0264 concentration−time data to permit reliable estimation of MLN0264 exposure. n in the categories is the number of participants with data available at the given time-point."||μg/mL||Standard Deviation|Mean
644728|NCT02202759|Secondary|Cmax: Maximum Observed Serum Concentration for MLN0264|Maximum observed serum concentration (Cmax) is the peak serum concentration of a drug after administration, obtained directly from the serum concentration-time curve.|Cycles 1-3 predose and 10 minutes, 4 hours, and 3, 4, 8 and 15 days postdose. Cycles 4+ predose, 10 minutes, 4 hours, and 4 and 8 days postdose.|Cmax was not a pre-specified secondary outcome measure. No data was collected.|||||
644729|NCT02202759|Secondary|Overall Survival (OS)|Overall survival is defined as the time in days from the date of first study drug administration to the date of death.|Until death or 6 months after the last patient completes treatment—whichever occurs first (Up to 17 months)|Response-evaluable population, all participants with measurable disease who received at least 1 dose of MLN0264 and had at least 1 postbaseline response assessment.||days||Full Range|Median
644730|NCT02202759|Secondary|Disease Control Rate|Disease control rate is defined as the percentage of participants with complete response (CR) or partial response (PR) or stable disease (SD) with a minimum of 12 weeks' duration. CR: Disappearance of all target lesions, non-target lesions, no new lesions, and normalization of tumor marker level. PR: At least a 30% decrease in the sum of the Longest Diameter (LD) of target lesions, taking as reference the baseline sum LD and no new lesions. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) of target lesions, taking as reference the smallest sum LD since the treatment started and no new lesions. Investigator response is based on the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.|Day 21 of every other 21-day cycle starting with Cycle 2, 30 days after the last dose of study medication, and then every 12 weeks for up to an additional 6 months (Up to 16.7 months)|Response-Evaluable population included all participants with measurable disease who received at least 1 dose of MLN0264 and had at least 1 post-baseline response assessment.||percentage of participants|||Number
644731|NCT02202759|Secondary|Duration of Response|Duration of response is defined as the time in days from the date of first documentation of a confirmed response to the date of first documentation of disease progression. Per RECIST v1.1 for target lesions and assessed by magnetic resonance imaging (MRI) - CR: Disappearance of all target lesions, non-target lesions, no new lesions, and normalization of tumor marker level. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesions.|From first documented response until disease progression (Up to 16.7 months)|Participants from the Response-Evaluable population, all participants with measurable disease who received at least 1 dose of MLN0264 and had at least 1 post-baseline response assessment, who had response.||days||Full Range|Median
644732|NCT02202759|Secondary|Progression Free Survival (PFS)|PFS is defined as the time in days from the date of first study drug administration to the date of first documentation of disease progression or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Time Frame: Day 21 of every other 21-day cycle starting with Cycle 2, 30 days after the last dose of study medication, and then every 12 weeks for up to an additional 6 months (Up to 16.7 months)|Response-Evaluable population included all participants with measurable disease who received at least 1 dose of MLN0264 and had at least 1 post-baseline response assessment.||days||Full Range|Median
644733|NCT02202759|Secondary|Number of Participants With Potentially Clinically Significant Vital Signs Findings|Participants with at least one potentially clinically significant post-baseline vital sign finding including measurements of diastolic and systolic blood pressure, heart rate, and oral temperature.|Day 1 of each 21 day cycle and 30 days after the last dose of study medication (Up to 10.7 months)|Safety population included all participants who received any amount of MLN0264.||participants|||Number
644748|NCT02202135|Primary|Clinical Response at TOC|Clinical cure is defined as resolution or improvement of signs and symptoms compared to baseline and no further antimicrobial therapy is necessary. Clinical failure is defined as any of the following: persistence or worsening in signs or symptoms, or requirement for concomitant antibiotic therapy, or requirement of an unplanned surgical intervention >48 hours after the first dose, or death caused by skin infection, or an AE leading to study drug discontinuation with alternative antimicrobial therapy required, or diagnosis of osteomyelitis >=8 days after the first dose.|7 to 20 days after last dose of study drug|Randomized||Participant|||Number
644734|NCT02202759|Secondary|Number of Participants With Potentially Clinically Significant Laboratory Evaluation Findings|Participants with at least one post-baseline potentially clinically significant serum chemistry, hematology, coagulation or urinalysis result. Clinically significant results are those that were assessed by the investigator to be Grade 3 or higher using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE). Grade 3=severe, Grade 4=life threatening or disabling and Grade 5=Death.|From the first dose through 30 days after the last dose of study medication (Up to 10.7 months)|Safety population included all participants who received any amount of MLN0264.||participants|||Number
644735|NCT02202759|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event. Relationship of each AE to study drug will be determined by the Investigator.|From the first dose through 30 days after the last dose of study medication (Up to 10.7 months)|Safety population included all participants who received any amount of MLN0264.||participants|||Number
644736|NCT02202759|Primary|Overall Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors (RECIST)|ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) as assessed by the investigator using Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR: Disappearance of all target lesions, non-target lesions, no new lesions, and normalization of tumor marker level. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesions.|Day 21, every other cycle, starting with Cycle 2 until disease progression, death or study closure (up to 17 months)|Response-Evaluable population included all participants with measurable disease who received at least 1 dose of MLN0264 and had at least 1 post-baseline response assessment.||percentage of participants|||Number
644737|NCT02202538|Secondary|Borg Rating of Perceived Exertion (BRPE) for Walking Indoors|"The BPRE characterizes the level of effort required by an individual to perform a task and takes into account both the person's fitness level and the difficulty of the task.
6: no exertion at all 7: extremely light 8-9: very light 10-11: light 12-13: somewhat hard 14-15: hard (heavy) 16-17: very hard 18-19: extremely hard 20: maximal exertion"|8 weeks|||units on a scale||Standard Deviation|Mean
644738|NCT02202538|Secondary|Functional Independence Measure (FIM) Score for Walking Indoors|"FIM measures an individual's level of disability and indicates how much assistance is needed for that individual to carry out activities of daily living.
7: complete independence 6: modified independence 5: supervision or setup assistance 4: minimal contact assistance 3: moderate assistance 2: maximal assistance
1: total assistance
Reference: rehabmeasures.org"|8 weeks|||units on a scale||Standard Deviation|Mean
644739|NCT02202538|Secondary|Walking Index for Spinal Cord Injury (WISCI-II) Assessment|"Assesses physical assistance and devices required for persons to walk following paralysis resulting from a Spinal Cord Injury.
0:unable
parallel bars, braces, help of 2 persons,<10m
parallel bars, braces, help of 2 persons,10m
parallel bars, braces, help of 1 person,10m
parallel bars, no braces, help of 1 person,10m
parallel bars, braces, no help,10m
walker, braces, help of 1 person,10m 7:2 crutches, braces, help of 1 person,10m
8:walker, no braces, help of 1 person,10m 9:walker, braces, no help,10m 10:1 cane/crutch, braces, help of 1 person,10m 11:2 crutches, no braces, help of 1 person,10m 12:2 crutches, braces, no help,10m 13:walker, no braces/help,10m 14:1 cane/crutch, no braces, help of 1 person,10m 15:1 cane/crutch, braces, no help,10m 16:2 crutches, no braces/help,10m 17:no devices/braces, help of 1 person,10m 18: no devices, braces, no help,10m 19:1cane/crutch, no braces/help,10m 20:no devices/braces/help,10m
Reference: rehabmeasures.org"|8 weeks|||units on a scale||Standard Deviation|Mean
644740|NCT02202538|Primary|Percentage of Subjects That Could Don/Doff the Device Independently|The percentage of participants that could don/doff the device independently at the end of the study, without the help of their Physical Therapist.|8 weeks|||percentage|||Number
644741|NCT02202538|Primary|Average Time to Don/Doff Device|Time needed for an individual to don or doff the device.|8 weeks|||minutes||Standard Deviation|Mean
644742|NCT02202538|Primary|Timed Up and Go (TUG) Test|Measures the time required for an individual to stand from a seated position, walk three meters, turn, walk back three meters, turn and return to a seated position.|8 weeks|||seconds||Standard Deviation|Mean
644743|NCT02202538|Primary|Average Speed of 10 Meter Walk Test (10MWT) Mid Study Versus End of Study|Measured time for an individual to complete walking 10 meters with the Indego and a stability aid midway through the study and at the end of the study.|4 weeks, 8 weeks|||meters/second||Standard Deviation|Mean
644744|NCT02202538|Primary|Percentage of Subjects Able to Complete the 600 Meter Walk Test (600MWT)|Measured time for an individual to complete walking 600 meters on a level surface with the Indego and stability aid at the end of the study, proposed to be representative of an individual's ability to ambulate in the community.|8 weeks|||percentage of participants|||Number
644745|NCT02202252|Other Pre-specified|Length of Hospital Stay||Participants will be followed for the duration of hospital stay, an expected average of 5 days|||days||Full Range|Median
644746|NCT02202252|Secondary|Seroma Formation|Seroma is defined as fluid accumulation below the flaps and will be examined daily after the operation. One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography..|Twenty-four hours after removal of the drains up to 4 weeks|||participants|||Number
644747|NCT02202252|Primary|Patient Comfort Scale|Patient comfort was measured with a comfort scale between 1-10 measuring incisional pain, pain caused by the drains, discomfort or sleep disturbances caused by the drains. 1 denotes no discomfort related to drains, 10 denotes maximum discomfort unrelieved even with nonsteroid antiinflammatory analgesics. The data will be presented by median value and range (minimum-maximum).|Postoperative 5 days|||units on a scale||Full Range|Median
644768|NCT02201901|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.|Posttreatment Week 12|The Full Analysis Set (FAS): participants who were randomized into the study and received at least 1 dose of study drug.||percentage of participants||95% Confidence Interval|Number
644749|NCT02201953|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as:
On-treatment virologic failure:
Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)
Virologic relapse:
Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 24|Full Analysis Set||percentage of participants|||Number
644750|NCT02201953|Secondary|Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24||Baseline; Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
644751|NCT02201953|Secondary|Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24||Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants||95% Confidence Interval|Number
644752|NCT02201953|Secondary|Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 are defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug.|Posttreatment Weeks 4 and 24|Full Analysis Set||percentage of participants||95% Confidence Interval|Number
644753|NCT02201953|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 24 weeks|Safety Analysis Set||percentage of participants|||Number
644754|NCT02201953|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug.||percentage of participants||95% Confidence Interval|Number
644755|NCT02201940|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as:
On-treatment virologic failure:
Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)
Virologic relapse:
Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 24|Full Analysis Set||percentage of participants|||Number
644756|NCT02201940|Secondary|Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, and 12||Baseline; Weeks 1, 2, 4, 6, 8, 10, and 12|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
644757|NCT02201940|Secondary|Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12||Weeks 1, 2, 4, 6, 8, 10, and 12|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants||95% Confidence Interval|Number
644758|NCT02201940|Secondary|Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set||percentage of participants||95% Confidence Interval|Number
644759|NCT02201940|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 12 weeks|Safety Analysis Set||percentage of participants|||Number
644760|NCT02201940|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants randomized or enrolled into the study and received at least 1 dose of study drug.||percentage of participants||95% Confidence Interval|Number
644761|NCT02201901|Secondary|Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 24 in Child-Pugh-Turcotte (CPT) Score|CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15; higher scores/increased scores indicate greater severity of disease.|Baseline to Posttreatment Week 24|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants|||Number
644762|NCT02201901|Secondary|Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 24 in MELD Score|Model for End-Stage Liver Disease (MELD) scores are used to assess prognosis and suitability for liver transplantation. Scores can range from 6 to 40; higher scores/increased scores indicate greater severity of disease.|Baseline to Posttreatment Week 24|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants|||Number
644763|NCT02201901|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as
On-treatment virologic failure
HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ, while on treatment,
> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment,
HCV RNA persistently ≥ LLOQ through 8 weeks of treatment (ie nonresponse)
Relapse
HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement"|Up to Posttreatment Week 24|Full Analysis Set||percentage of participants||95% Confidence Interval|Number
644764|NCT02201901|Secondary|Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24||Baseline; Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
644765|NCT02201901|Secondary|Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24||Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants|||Number
644766|NCT02201901|Secondary|Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set||percentage of participants||95% Confidence Interval|Number
644767|NCT02201901|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 24 weeks plus 30 days|Safety Analysis Set||percentage of participants|||Number
644769|NCT02201784|Other Pre-specified|Pulse Rate, Mean Arterial Pressure, SpO2|Intragroup and intergroup variation compared|8 hours||||||
644770|NCT02201784|Secondary|Duration of Motor Block|Time when the Bromage score will be back to zero|8 hours|||minutes||Standard Deviation|Mean
644771|NCT02201784|Secondary|Onset of Motor Block to Bromage3|Motor block in the lower limbs was graded according to the modified Bromage scale (Grade 0 = No motor block, Grade 1 = Inability to raise extended leg, able to move knees and feet, Grade 2 = Inability to raise extended leg and move knee, able to move feet, Grade 3 = Complete motor block of the lower limbs). Thereafter, It was performed every 5 minutes till the attainment of MB grade 3 followed by every 30 minutes until complete recovery (MB grade0).|8 hours|||minutes||Standard Deviation|Mean
644772|NCT02201784|Secondary|Time to Maximum Cephalic Spread of Sensory Block||8 hours|||minutes||Standard Deviation|Mean
644773|NCT02201784|Secondary|Median Maximum Level of Sensory Blockade|level of sensory block was assessed every 5 minutes till the loss of sensation to pinprick, using 22-guage hypodermic needle with 2mm protrusion through guard. Assessments continued at 30 min intervals following the completion of surgery until normal sensation returned.|8 hours||||||
644774|NCT02201784|Secondary|Onset of Sensory Block at T10|level of sensory block was assessed every 5 minutes till the loss of sensation to pinprick, using 22-guage hypodermic needle with 2mm protrusion through guard. Assessments continued at 30 min intervals following the completion of surgery until normal sensation returned.|30 minutes|||minutes||Standard Deviation|Mean
644775|NCT02201784|Primary|Duration of Analgesia|Defined as time for first analgesic request by the patient|8 hours|||minutes||Standard Deviation|Mean
644776|NCT02201524|Secondary|Number of Participants Reporting Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameters|ECG change data was reported as qualitative results, as per change in planned analysis. It was categorized as: normal; abnormal, not clinically significant or abnormal, clinically significant.|Baseline up to Week 8 (early termination)|The safety analysis population set included all enrolled participants who received at least 1 dose of study drug.||participants|||Number
644777|NCT02201524|Secondary|Number of Participants Reporting Clinically Significant Change From Baseline in Heart Rate||Baseline up to Week 8 (early termination)|The safety analysis population set included all enrolled participants who received at least 1 dose of study drug.||bpm|||Number
644778|NCT02201524|Secondary|Change From Baseline in Body Temperature at Week 1, 2, 3, 4, 5, 6, and 8||Baseline, Week 1, 2, 3, 4, 5, 6, 8 (early termination)|The safety analysis population set included all enrolled participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||degree celsius||Standard Deviation|Mean
644779|NCT02201524|Secondary|Change From Baseline in Respiratory Rate at Week 1, 2, 3, 4, 5, 6, and 8||Baseline, Week 1, 2, 3, 4, 5, 6, 8 (early termination)|The safety analysis population set included all enrolled participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||respiration per minute (resp/min)||Standard Deviation|Mean
644780|NCT02201524|Secondary|Change From Baseline in Pulse Rate at Week 1, 2, 3, 4, 5, 6, and 8||Baseline, Week 1, 2, 3, 4, 5, 6, 8 (early termination)|The safety analysis population set included all enrolled participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||beats per minute (bpm)||Standard Deviation|Mean
644781|NCT02201524|Secondary|Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8||Baseline, Week 1, 2, 3, 4, 5, 6, 8 (early termination)|The safety analysis population set included all enrolled participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||millimeter of mercury (mmHg)||Standard Deviation|Mean
644782|NCT02201524|Secondary|Number of Participants Reporting Clinically Significant Change From Baseline in Herpes Simplex Virus Deoxyribonucleic Acid (HSV DNA) Values|HSV DNA samples were collected and changes from baseline were evaluated by the PI for clinical significance. Clinical significance is levels outside of the normal range (abnormal levels) with clinically apparent viral disease, or that resulted in AEs or required follow-up.|Baseline up to Week 8 (early termination)|The safety analysis population set included all enrolled participants who received at least 1 dose of study drug.||participants|||Number
644783|NCT02201524|Secondary|Number of Participants Reporting Clinically Significant Change From Baseline in Cytomegalovirus (CMV) Values|CMV samples were collected and changes from baseline were evaluated by the PI for clinical significance. Clinical significance is levels outside of the normal range (abnormal levels) with clinically apparent viral disease, or that resulted in AEs or required follow-up.|Baseline up to Week 8 (early termination)|The safety analysis population set included all enrolled participants who received at least 1 dose of study drug.||participants|||Number
644784|NCT02201524|Secondary|Number of Participants Reporting Clinically Significant Change From Baseline in Epstein-Barr Virus (EBV) Values|EBV samples were collected and changes from baseline were evaluated by the principal investigator (PI) for clinical significance. Clinical significance is levels outside of the normal range (abnormal levels) with clinically apparent viral disease, or that resulted in adverse event (AEs) or required follow-up.|Baseline up to Week 8 (early termination)|The safety analysis population set included all enrolled participants who received at least 1 dose of study drug.||participants|||Number
644785|NCT02201524|Secondary|Change From Baseline in High Sensitivity C- Reactive Protein (hsCRP) at Week 1, 2, 3, 4, and 8|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Reference range for measurements is 0-0.5 mg/dL and lower limit of detection is less than (<) 0.015 mg/dL. Any value <0.015 mg/dL is imputed as 0.0075 mg/dL.|Baseline, Week 1, 2, 3, 4, 8 (early termination)|The safety analysis population set included all enrolled participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||mg/dL||Standard Deviation|Mean
644786|NCT02201524|Secondary|Change From Baseline in Lipid Ratios at Week 2, 4 and 8|The ratio of LDL-C/HDL-C was reported.|Baseline, Week 2, 4, 8 (early termination)|The safety analysis population set included all enrolled participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||ratio||Standard Deviation|Mean
644848|NCT02198040|Primary|Changes in the Pain Perception of Elbow|Using the visual analogue scale, VAS (subjective rating scale with a score from 0 to 10, where 0 indicates no pain and 10 the maximum pain imaginable by the patient).|Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)|||points||Standard Deviation|Mean
644787|NCT02201524|Secondary|Change From Baseline in Fasting Lipids at Week 2, 4 and 8|Participants were required to fast 9 hours prior to sampling for lipid profile which included following parameters: low-density lipoprotein-cholesterol (LDL-C), high-density lipoprotein-cholesterol (HDL-C), cholesterol, triglycerides.|Baseline, Week 2, 4, 8 (early termination)|The safety analysis population set included all enrolled participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||milligram per deciliter (mg/dL)||Standard Deviation|Mean
644788|NCT02201524|Secondary|Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear' at Week 1, 2, 3, 4, 5, 6, and 8|The PGA of psoriasis was scored on a 5-point scale, reflecting a global consideration of the erythema (E), induration (I), and scaling (S) across all psoriatic lesions. The severity rating scores (erythema: 0= no evidence of erythema to 4= dark, deep red; Induration: 0= no evidence of plaque elevation to 4= marked plaque elevation, hard/sharp borders; Scaling: 0= no evidence of scaling to 4= thick, coarse scale predominates) were summed (E + I + S= total) and the average (total/3) was taken. The total average was rounded to the nearest whole number score to determine the PGA. The 5-point scale for PGA was: 0= clear; 1= almost clear; 2= mild; 3= moderate; 4= severe, where higher score indicating more severity. Participants with response of clear and almost clear were reported. 90 percent confidence intervals were calculated using clopper-pearson (exact) method.|Week 1, 2, 3, 4, 5, 6, 8|The mITT analysis set included all randomized participants who received at least 1 dose of the randomized study drug. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||percentage of participants||90% Confidence Interval|Number
644789|NCT02201524|Secondary|Percentage of Participants Achieving 90 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8|PASI score is combined assessment of lesion severity and area affected into single score range:0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck [h], arms [u], trunk [t], legs [l]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated:0 (no involvement) to 6 (90–100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4). Participants who had at least 90 percent reduction in PASI score relative to baseline PASI Score are reported. 90 percent confidence intervals are calculated using clopper-pearson (exact) method.|Baseline, Week 1, 2, 3, 4, 5, 6, 8 (early termination)|The mITT analysis set included all randomized participants who received at least 1 dose of the randomized study drug. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||percentage of participants||90% Confidence Interval|Number
644790|NCT02201524|Secondary|Percentage of Participants Achieving 75 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6 and 8|PASI score is combined assessment of lesion severity and area affected into single score range:0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck [h], arms [u], trunk [t], legs [l]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated:0 (no involvement) to 6 (90–100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4). Participants who had at least 75 percent reduction in PASI score relative to baseline PASI Score are reported. 90 percent confidence intervals are calculated using clopper-pearson (exact) method.|Baseline, Week 1, 2, 3, 4, 5, 6, 8|The mITT analysis set included all randomized participants who received at least 1 dose of the randomized study drug. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||percentage of participants||90% Confidence Interval|Number
644791|NCT02201524|Secondary|Percentage of Participants Achieving 50 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8|PASI score is combined assessment of lesion severity and area affected into single score range:0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck [h], arms [u], trunk [t], legs [l]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated:0 (no involvement) to 6 (90–100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4). Participants who had at least 50 percent reduction in PASI score relative to baseline PASI Score are reported. 90 percent confidence intervals are calculated using clopper-pearson (exact) method.|Baseline, Week 1, 2, 3, 4, 5, 6, 8|The mITT analysis set included all randomized participants who received at least 1 dose of the randomized study drug. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||percentage of participants||90% Confidence Interval|Number
644792|NCT02201524|Secondary|Change From Baseline in PASI Score at Week 1, 2, 3, 5, 6 and 8|PASI score is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck [h], arms [u], trunk [t], legs [l]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated: 0 (no involvement) to 6 (90–100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4).|Baseline, Week 1, 2, 3, 5, 6, 8|The mITT analysis set included all randomized participants who received at least 1 dose of the randomized study drug. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||units on a scale||Standard Deviation|Mean
648281|NCT02107014|Primary|Change in IL-6 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].|||pg/mL||95% Confidence Interval|Median
644793|NCT02201524|Secondary|Percent Change From Baseline in PASI Score at Week 1, 2, 3, 4, 5, 6, and 8|PASI score is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck [h], arms [u], trunk [t], legs [l]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated: 0 (no involvement) to 6 (90–100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4).|Baseline, Week 1, 2, 3, 4, 5, 6, 8|The mITT analysis set included all randomized participants who received at least 1 dose of the randomized study drug. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||percent change||Standard Deviation|Mean
644794|NCT02201524|Primary|Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 4|PASI score is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck [h], arms [u], trunk [t], legs [l]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated: 0 (no involvement) to 6 (90–100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4).|Baseline, Week 4|The modified intent to treat (mITT) analysis set included all randomized participants who received at least 1 dose of the randomized study drug (PF-04965842 or placebo). Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||units on a scale||Standard Deviation|Mean
644795|NCT02201446|Secondary|MIF||Day 3|Only 62 ARDS patients with Day 3 blood samples were analyzed||ng/ml||Standard Deviation|Mean
644796|NCT02201446|Secondary|IL-6||Day 3|Only 62 ARDS patients with Day 3 blood samples were analyzed||pg/ml||Standard Deviation|Mean
644797|NCT02201446|Secondary|TNF-α||Day 3|Only 62 ARDS patients with Day 3 blood samples were analyzed||pg/ml||Standard Deviation|Mean
644798|NCT02201446|Secondary|Death||up to 28 days|||participants|||Number
644799|NCT02201446|Secondary|Days of Unassisted Ventilation||1 year|||days||Inter-Quartile Range|Mean
644800|NCT02201446|Secondary|Length of Hospital Stay||1 year|||days||Inter-Quartile Range|Mean
644801|NCT02201446|Secondary|Length of Stay in the ICU||1 year|not collected for healthy volunteers||days||Inter-Quartile Range|Mean
644802|NCT02201446|Primary|Serum Soluble Cluster of Differentiations 74 (sCD74)|The concentration of sCD74 was determined using Elx800 (BioTek Instruments, Inc. VT), and normalization was based on concentration-response curves, using CD74 recombinant protein.|Day 3|Only 62 ARDS patients with Day 3 blood samples were analyzed.||ng/ml||Standard Deviation|Mean
644803|NCT02201446|Primary|Serum Soluble Cluster of Differentiations 74 (sCD74)|The concentration of sCD74 was determined using Elx800 (BioTek Instruments, Inc. VT), and normalization was based on concentration-response curves, using CD74 recombinant protein.|Day 1|||ng/ml||Standard Deviation|Mean
644804|NCT02201446|Primary|Acute Physiology and Chronic Health Evaluation (APACHE) II Scores|APACHE II scores range from 0 to 71. A higher values represent a worse outcome.|up to 28 days|not collected for healthy volunteers||Scores on a scale||Standard Deviation|Mean
644805|NCT02201446|Primary|Fraction of Inspired Oxygen (FiO2)/Partial Arterial Oxygen Pressure (PO2)||up to 28 days|not collected for healthy volunteers||ratio||Standard Deviation|Mean
644806|NCT02201446|Primary|Number of Participants Receiving Mechanical Ventilation||up to 28 days|not collected for healthy volunteers||participants|||Number
644807|NCT02201420|Secondary|Time to Localization|Number of Participants with Localization at One Hour|1 hour|||participants localizing in 1 hour|||Number
644808|NCT02201420|Primary|Localization|Count of subjects with a localization by Tc 99m tilmanocept by imaging. Localization is based on the use of SPECT imaging and defined as the accumulation of radioactivity at intensity greater than background.|Up to 4 days|||participants|||Number
644809|NCT02201056|Secondary|AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity of TAK-935||Multiple time-points (Up to 96 hours) post-dose|PK set included all participants in the safety set who had at least 1 measurable plasma or urine concentration.||ng*hr/mL||Standard Deviation|Mean
644810|NCT02201056|Secondary|AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-935||Multiple time-points (Up to 96 hours) post-dose|PK set included all participants in the safety set who had at least 1 measurable plasma or urine concentration.||ng*hr/mL||Standard Deviation|Mean
644811|NCT02201056|Secondary|Cmax: Maximum Observed Plasma Concentration for TAK-935||Multiple time-points (Up to 96 hours) post-dose|Pharmacokinetic (PK) set included all participants in the safety set who had at least 1 measurable plasma or urine concentration.||ng/mL||Standard Deviation|Mean
644812|NCT02201056|Primary|Percentage of Participants Who Meet the Markedly Abnormal Criteria, for Electrocardiogram (ECG) Measurements at Least Once Post-dose|The percentage of participants with any markedly abnormal criteria for standard 12-lead ECG measured collected during the treatment period.|Day 1 to Day 14|Safety set included all participants who were enrolled and received study drug.||percentage of participants|||Number
644813|NCT02201056|Primary|Percentage of Participants Who Meet Markedly Abnormal Criteria, for Vital Sign Measurements at Least Once Post-dose|The percentage of participants with any markedly abnormal vital signs (oral temperature, respiration rate, pulse, and blood pressure) collected during the treatment period.|Day 1 to Day 14|Safety set included all participants who were enrolled and received study drug.||percentage of participants|||Number
644814|NCT02201056|Primary|Percentage of Participants Who Meet the Markedly Abnormal Criteria, for Safety Laboratory Tests at Least Once Post-dose|The percentage of participants with any markedly abnormal standard safety laboratory values (hematology, serum chemistries, and urinalysis) collected during the treatment period.|Day 1 to Day 14|Safety set included all participants who were enrolled and received study drug.||percentage of participants|||Number
644815|NCT02201056|Primary|Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE)|An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug and within 30 days after the last dose of study drug.|Day 1 to Day 30|Safety set included all participants who were enrolled and received study drug.||percentage of participants|||Number
644816|NCT02200536|Secondary|Change in Mother's Reported Bottle-feeding Practice.|Change in mother's reported bottle-feeding practice was measured by comparing mother's reported bottle-feeding practice at follow up and baseline. Change was present when mother's reported no bottle-feeding practice after one month compared to mother's reported bottle-feeding practice at baseline. Change was not present when mother's reported bottle-feeding practice after one month compared to mother's reported bottle-feeding practice at baseline.|Baseline (T0) and after one month (T1)|||percentage of mothers|||Number
644817|NCT02200536|Primary|Change in Mother's Reported Infant's Twice-a-day Tooth Brushing Practice.|Change in mother's reported infant's twice-a-day tooth brushing practice was measured by comparing mother's reported infant's twice-a-day tooth brushing practice at follow up and baseline. Change was present when mother's reported infant's twice-a-day tooth brushing practice after one month compared to mother's reported no infant's twice-a-day tooth brushing practice at baseline. Change was not present when mother's did not report infant's twice-a-day tooth brushing practice after one month compared to mother's reported no infant's twice-a-day tooth brushing practice at baseline.|Baseline (T0) and after one month (T1)|||percentage of mothers|||Number
644818|NCT02200458|Primary|Number of Participants for Whom Successful Visualization of Vasculature Was Achieved||One day|||participants|||Number
644819|NCT02200328|Secondary|Determine Differences in Clostridium Difficile Diarrhea Incidence Between Patients on Piperacillin/Tazobactam vs. Patients on Ciprofloxacin.||30 days|0 participants were analyzed due to large number of patients not complying to the instructions and loss to follow up.|||||
644820|NCT02200328|Primary|The Incidence of Clostridium Difficile Diarrhea in Both Study Groups at 30 Days Post Broad Spectrum Antibiotic Use.||30 days|0 participants were analyzed due to large number of patients not complying to the instructions and loss to follow up.|||||
644821|NCT02199717|Primary|Sedentary Time|To determine if the amount of time spent in sedentary time on a weekly basis differs by the level of disease severity in the pediatric hemophilia population.|7 days|All statistical analyses were completed using SAS 9.4 (SAS Institute Inc., Cary, NC, USA). Descriptive statistics such as mean (± SD) and range were calculated and provided for demographic variables, accelerometry variables and questionnaire outcomes. Differences between the two groups were examined in exploratory analyses.||minutes per day||Standard Deviation|Mean
644822|NCT02199717|Primary|MVPA|To determine if the amount of time spent performing moderate to vigorous physical activity (MVPA) engaged in on a weekly basis differs by the level of disease severity in the pediatric hemophilia population.|7 days|All statistical analyses were completed using SAS 9.4 (SAS Institute Inc., Cary, NC, USA). Descriptive statistics such as mean (± SD) and range were calculated and provided for demographic variables, accelerometry variables and questionnaire outcomes. Differences between the two groups were examined in exploratory analyses.||minutes per day||Standard Deviation|Mean
644823|NCT02199574|Primary|The Apparent Terminal Elimination Rate Constant (λz)||From time of study drug administration through Day 7 postdose|||1/hours||Standard Deviation|Mean
644824|NCT02199574|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC(0-infinity))||From time of study drug administration through Day 7 postdose|||hours*ng/mL||Standard Deviation|Mean
644825|NCT02199574|Primary|Apparent Terminal Elimination Half-life||From time of study drug administration through Day 7 postdose|||hours||Standard Deviation|Mean
644826|NCT02199574|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC(0-t))||From time of study drug administration through Day 7 postdose|||hours*ng/mL||Standard Deviation|Mean
644827|NCT02199574|Primary|Time to Maximum Plasma Concentration (Tmax)||From time of study drug administration through Day 7 postdose|||hours||Full Range|Median
644828|NCT02199574|Primary|Maximum Plasma Concentration (Cmax)||From time of study drug administration through Day 7 postdose|||ng/mL||Standard Deviation|Mean
644829|NCT02199509|Secondary|Percent Change of the Sum of Eyes and Upper Face, Lower Face and Jaw and Tongue Subscores of the GDS Rating Scale|The Global Dystonia Severity Scale provides a severity rating for ten body regions, i.e.,1) eyes and upper face, 2) lower face, 3) jaw and tongue, 4) larynx, 5) neck, 6) shoulder and proximal arm, 7) distal arm and hand including elbow, 8) pelvis and upper leg, 9) distal leg and foot, and 10) trunk. Each body area is rated from 0 to 10, with 0 representing no dystonia present in that body area and 10 representing severe dystonia. The secondary outcome measure includes the sum of the eyes and upper face, lower face and jaw and tongue subscores of the GDS rating scale and represents the percent change from baseline to either 3 and 6 weeks or 11 and 14 weeks (representing the end of the three week titration period (3 weeks and 11 weeks) and the post-3 week period (6 weeks and 14 weeks) at the maximum tolerated dose for Levetiracetam or Placebo). The total range of these combined sub scores is 0-30, with higher scores indicating more severe dystonia and 0 indicating absence of|3, 6, 11 and 14 compared to baseline|||Percentage of change||Standard Deviation|Mean
644830|NCT02199509|Secondary|Percent Change of the Sum of the Eyes, Mouth, Speech and Swallowing Subscores of Burke-Fahn-Marsten Dystonia Rating Scale (BFM)|The Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) is a measure of dystonia severity. The scale consists of evaluation of ten body parts (eyes, mouth, speech, swallowing, neck, trunk, right arm, right leg, left arm and left leg). The severity and provoking factors for each part are rated using a 5-point scale. These range from 0 (indicating no dystonia) to 4 (indicating the presence of dystonia at rest). The secondary outcome measure includes the sum of the eyes, mouth, speech and swallowing subscores and represents the percent change from baseline to either 3 weeks or 11 weeks (representing the end of the three week titration period up to the maximum tolerated dose for Levetiracetam or Placebo). The total range for these combined sub scores is 0-16, with higher scores indicating more severe dystonia and 0 indicating absence of dystonia.|3 and 11 weeks compared to baseline|||percent change||Standard Deviation|Mean
644831|NCT02199509|Primary|Percent Change of the Sum of the Eyes, Mouth, Speech and Swallowing Subscores of the Burke-Fahn-Marsden (BFM) Dystonia Scale.|The Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) is a measure of dystonia severity. The scale consists of evaluation of nine body parts (eyes, mouth, speech, swallowing, neck, trunk, right arm, right leg, left arm and left leg). The severity and provoking factors for each part are rated using a 5-point scale. These range from 0 (indicating no dystonia) to 4 (indicating the presence of dystonia at rest). The primary outcome measure includes the sum of the eyes, mouth, speech and swallowing subscores and represents the percent change from baseline to either 6 weeks or 14 weeks (representing the end of the 3 week period at the maximum tolerated dose for Levetiracetam or Placebo). The total range for these combined sub scores is 0-16, with higher scores indicating more severe dystonia and 0 indicating absence of dystonia.|6 and 14 weeks compared to baseline|||percent change||Standard Deviation|Mean
644832|NCT02198963|Primary|Cumulative Irritation Score of RUT058-60 Hypochlorous Acid Solution (106 mg/L) on Healthy Human Skin|"Primary Analysis After a 23-hour ± 1-hour period of exposure, patches were removed, and the sites evaluated and visually scored for irritancy. The procedures will be repeated on the same test sites an additional twenty times. On each day,mean values, sample sizes, ranges, etc., of the irritation scores, for a total of six configurations, were recorded.
Grading Scale for Visual Evaluation of Skin Condition: 0= no evidence of irritation, 1= minimal erythema, barely perceptible, 2= definite erythema, readily visible; minimal edema or minimal papular response, 3= erythema and papules, 4= definite edema, 5= erythema, edema, and papules, 6=' vesicular eruption, 7= strong reaction spreading beyond test site Visual observations of 3, 4, or 5 resulted in discontinuance of product application to that site. Observations of 6 or 7 were considered an adverse event and subject discontinued from the study."|21 days|Each subject had each study material (test, positive and negative controls) applied to separate abraded and non-abraded skin sites||units on a scale||Standard Deviation|Mean
644833|NCT02198833|Secondary|Device Specific Adverse Event Assessments|Patient will be assessed daily for signs and symptoms of infection. Catheter placement and patency will be confirmed. Insertion site will be evaluated for signs of inflammation and or trauma.|15 Days|No analysis completed. Study catheter placed in only 2 patients due to inability to clear bacterial from urinary bladder during screening.|||||
644834|NCT02198833|Secondary|Assess the Microbial Coverage and Biofilm Formation on Catheter Surface|Catheters will be cultured by Roll-plate method for microbial growth. Catheters removed at the Houston site will also be evaluated by scanning electron microscopy to determine microbial coverage and biofilm formation.|Day 15 or upon removal of Foley Catheter|No analysis completed. Study catheter placed in only 2 patients due to inability to clear bacterial from urinary bladder during screening.|||||
644835|NCT02198833|Secondary|Time to Occurrence of Asymptomatic Bacteruria or Funguria|Urine cultures will be obtained every third day to assess for the presence of microbial growth.|15 days|No analysis completed. Study catheter placed in only 2 patients due to inability to clear bacterial from urinary bladder during screening.|||||
644836|NCT02198833|Primary|Delay Onset of Catheter Associated Symptomatic Urinary Tract Infection|Patients will be assessed daily for the occurrence of signs and symptoms of urinary tract infection. A single, independent evaluator (PI/co-investigator) will determine whether the subject has a catheter associated urinary tract infection based on pre-defined criteria that involve symptom reports and lab values without knowledge of or access to the catheter type randomly assigned to the patient.|15 Days|No analysis completed due to inability to place study catheter due to persistent bacterial colonization.|||||
644837|NCT02198430|Secondary|Measure of Weight|Measure of weight|Screening visit (pretreatment assessment)|||Kg||Standard Deviation|Mean
644838|NCT02198430|Secondary|Assessment of Clinical Patient Variables|Hemophilia type measuring (A or B)|Screening visit|||Percentage of Participants with Hemophil|||Number
644839|NCT02198430|Primary|Assess the Perception of Quality of Life|Measurement through the Child health profile (Childhood Health and Illness Perception; CHIP-CE).|Screening visit|The score ranges from 0 (poor QoL) to 100 points (good perception of QoL).||points||Standard Deviation|Mean
644840|NCT02198430|Primary|Assess the Joint Damage|Measurement with Haemophilia Joint Health Score 2.1 (HJHS)|Screening visit|Haemophilia Joint Health Score assesses joint health in patients with hemophilia. It consists of eight dimensions: swelling, muscular atrophy, crepitation and range of motion, joint pain, strength, motion and axial alignment. The score range is from 0 to 24 points (a score of 0 indicates no joint damage. The higher the score, the higher).||points||Standard Deviation|Mean
644841|NCT02198235|Secondary|Median Time to Requiring Oral Opioids|Did patient have pain requiring oral opioids?|24 hours after the popliteal block is given|||hours||95% Confidence Interval|Median
644842|NCT02198235|Secondary|Numeric Rating Scale (NRS) Pain Score at Rest|Pain at rest at 24 hours from the nerve block (0-10; 0 = no pain, 10 = worst possible pain)|24 hours after the popliteal block is given|||units on a scale||Standard Error|Mean
644843|NCT02198235|Secondary|Block Duration|When did the nerve block entirely wear off?|24 hours and 48 hours after the popliteal block is given|||hours||95% Confidence Interval|Median
644844|NCT02198235|Primary|Numeric Rating Scale (NRS) Pain Score With Movement|Pain with movement at 24 hours from the nerve block (0-10; 0 = no pain, 10 = worst possible pain)|24 hours after the popliteal block is given|||units on a scale||Standard Deviation|Mean
644845|NCT02198040|Secondary|Frequency of Elbow Hemarthrosis|Number of elbow hemarthrosis in the month prior to study|Screening visit (pretreatment assessment)|||bleeding events||Standard Deviation|Mean
644846|NCT02198040|Secondary|Characteristics of the Patients|Age of patients included in teh study (years)|Screening visit (pretreatment assessment)|||years||Standard Deviation|Mean
644847|NCT02198040|Primary|Assessment of Radiological Joint Deterioration|Pettersson scale is an additive scale that assesses the radiological joint damage in patients with hemophilic arthropathy. It is scored as a range of 0-13 points (0: no joint damage; 13: maximum joint damage). This scale assesses: osteoporosis, widened epiphyseal, irregularity of the chondral surface, joint space narrowing, subchondral cyst formation, joint margins erosion, joint incongruence and joint deformity (angulation and displacement)|Screening visit (pretreatment assessment)|It has made an analysis by intention to treat with the 27 patients included in the study. It has been estimated the radiological joint damage means (and standard deviation) for elbow joint.||points||Standard Deviation|Mean
644899|NCT02196714|Secondary|Change in Mean Glucose and Potassium Results (±SD) From Pre-dose to 12 Hours Post-dose|Change in Mean Glucose and Potassium Results (±SD) from Pre-dose to 12 Hours Post-dose|12 hours|Safety Population||mmol/L||Full Range|Mean
644850|NCT02198040|Primary|Changes in the Circumference of Arm|Measurement of the arm circumference (in cm) at baseline as a result of hemophilic arthropathy and after treatment and follow-up. The measurement in the upper third of the arm, in the middle of the triceps muscle belly, with a tape measure. We use this outcome to measure circumference of the arm, it is the most clinical measurement used by physiotherapists.|Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)|It has made an analysis by intention to treat with the 27 patients included in the study||cm||Standard Deviation|Mean
644851|NCT02198040|Primary|Changes in Range of Motion of Elbow|Measurement the changes of flexion and extension of elbow (in degrees) using a universal goniometer. We were taken as anatomical references, those specified by Querol et al, using the zero-method-reference for the mobile arm goniometer as indicated Norkin et al.|Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)|It has made an analysis by intention to treat with the 27 patients included in the study.||degrees||Standard Deviation|Mean
644852|NCT02197806|Primary|Percentage of Participants With at Least a 2 Line Improvement From Baseline in Uncorrected Near Visual Acuity (UNVA) in the Non-Dominant Eye|UNVA is assessed without corrective lenses in the non-dominant eye. UNVA is measured using an eye chart and is reported as the number of lines read correctly. The lower the number of lines read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of lines read correctly means that vision has improved. The percentages of patients with at least a 2 or more line improvement in UNVA in the non-dominant eye are presented.|Baseline, Day 3|Modified Intent to Treat: all randomized patients with a baseline assessment and at least 1 postbaseline assessment of UNVA||Percentage of Patients|||Number
644853|NCT02197455|Secondary|Mean Change in Skindex 16 Scores|Skindex 16 is a quality of life questionaire with a range of 0-100 wherein 1 is not bothered by the condition and 100 is always bothered by the condition|3 months|||units on a scale||Full Range|Mean
644854|NCT02197455|Primary|Mean Change in Severity of Alopecia Tool (SALT) Score|SALT score range is from 0 (no hair loss) to 100 (100% hair loss)|3 months|||percent change in SALT score||Standard Deviation|Mean
644855|NCT02197273|Secondary|Readmission or Emergency Department (ED) Visit Due to Pain Control Within 30 Days||Date of discharge through 30 days following discharge|||participants|||Number
644856|NCT02197273|Secondary|Time to Post-operative Rescue Opioids (Hours)||Immediately following discharge from operating room until the participant was discharged from the hospital, an expected average of 3 days|||hours||Full Range|Median
644857|NCT02197273|Primary|Length of Stay in Hospital (Days)||Participants were followed for the duration of hospital stay, an expected average of 3 days|||days||Full Range|Median
644900|NCT02196714|Secondary|Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose|Change in Mean Chemistry Parameters (±SD) from Pre-dose to 12 Hours Post-dose (Ferritin)|12 hours|Safety Population||μg/L||Standard Deviation|Mean
644876|NCT02197234|Secondary|AUC(0-t) of Simvastatin and Simvastatin Acid|Pharmacokinetics of simvastatin and simvastatin acid by assessment of area under the plasma concentration time curve from time zero to last quantifiable dose|Blood samples collected on Days 1 and 31 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 28, and 32 hours post simvastatin dose in Part A|Pharmacokinetic population - all patients who received at least 1 dose of simvastatin or AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations.||ng.h/mL||Full Range|Geometric Mean
644877|NCT02197234|Secondary|AUC of Simvastatin Acid|Pharmacokinetics of simvastatin acid by assessment of area under the plasma concentration time curve from zero to infinity|Blood samples collected on Days 1 and 31 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 28, and 32 hours post simvastatin dose in Part A|Pharmacokinetic population - all patients who received at least 1 dose of simvastatin or AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations.||ng.h/mL||Full Range|Geometric Mean
644878|NCT02197234|Secondary|Cmax of Simvastatin Acid|Pharmacokinetics of simvastatin acid by assessment of maximum plasma simvastatin acid concentration|Blood samples collected on Days 1 and 31 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 28, and 32 hours post simvastatin dose in Part A|Pharmacokinetic population - all patients who received at least 1 dose of simvastatin or AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations.||ng/mL||Full Range|Geometric Mean
644879|NCT02197234|Secondary|CL/F of Simvastatin|Rate and extent of absorption of simvastatin by assessment of apparent clearance following oral administration|Blood samples collected on Days 1 and 31 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 28, and 32 hours post simvastatin dose in Part A|Pharmacokinetic population - all patients who received at least 1 dose of simvastatin or AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations.||L/h||Full Range|Geometric Mean
644880|NCT02197234|Secondary|Tmax of Simvastatin and Simvastatin Acid|Pharmacokinetics of simvastatin and simvastatin acid by time to Cmax|Blood samples collected on Days 1 and 31 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 28, and 32 hours post simvastatin dose in Part A|Pharmacokinetic population - all patients who received at least 1 dose of simvastatin or AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations.||hours||Full Range|Median
644881|NCT02197234|Primary|AUC of Simvastatin|Pharmacokinetics of simvastatin by assessment of area under the plasma concentration time curve from zero to infinity|Blood samples collected on Days 1 and 31 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 28, and 32 hours post simvastatin dose in Part A|Pharmacokinetic population - all patients who received at least 1 dose of simvastatin or AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations.||ng.h/mL||Full Range|Geometric Mean
644882|NCT02197234|Primary|Cmax of Simvastatin|Pharmacokinetics of simvastatin by assessment of maximum plasma simvastatin concentration|Blood samples collected on Days 1 and 31 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 28, and 32 hours post simvastatin dose in Part A|Pharmacokinetic population - all patients who received at least 1 dose of simvastatin or AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations.||ng/mL||Full Range|Geometric Mean
644883|NCT02197065|Secondary|Peri-operative Rise in Interleukin-6 (IL-6) Levels|The change in the level of IL-6 from baseline to POD2 in 16 arthroplasty patients randomized (1:1) to atorvastatin 40mg versus placebo.|Change from preoperative to postoperative day 2|16 arthroplasty patients||pg/mL||Inter-Quartile Range|Median
644884|NCT02197065|Primary|Peri-operative Rise in High Sensitivity C-reactive Protein (Hs-CRP)|The change in the level of hs-CRP from baseline to POD2 in 20 orthopedic patients randomized (1:1) to atorvastatin 40mg versus placebo.|Change from preoperative to post-operative day 2|||mg/L||Inter-Quartile Range|Median
644885|NCT02197065|Primary|Percentage of All Enrolled Patients With a Peri-operative Rise in High-sensitivity Cardiac Troponin I|The percentage of orthopedic patients with a ≥ 10 pg/mL rise in high-sensitivity cardiac troponin I (hs-cTnI) from baseline pre-operatively to post-operative day (POD)2|change from preoperative to postoperative day 2|20 orthopedic surgery patients.||percentage of patients|||Number
644886|NCT02196766|Primary|Ocular Health - Papillary Conjunctivitis|Papillary conjunctivitis for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).|1 week|||Eyes|Participants||Number
644887|NCT02196766|Primary|Ocular Health - Limbal Redness|Limbal redness for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).|1 week|||Eyes|Participants||Number
644888|NCT02196766|Primary|Ocular Health - Conjunctival Redness|Conjunctival redness for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).|1 week|||Eyes|Participants||Number
644889|NCT02196766|Secondary|Burning Sensation Right After Insertion (Subjective Rating)|Subjective rating of burning sensation right after insertion for each combination assessed at baseline. (Scale 0-10; 0=difficult to wear, 10=no sensation at all).|Baseline|||units on a scale||Standard Deviation|Mean
644890|NCT02196766|Secondary|Stinging Sensation Right After Insertion (Subjective Rating)|Subjective rating of stinging sensation for the combinations is assessed at baseline. (Scale 0-10; 0=difficult to wear, 10=no sensation at all).|Baseline|||units on a scale||Standard Deviation|Mean
644891|NCT02196766|Primary|Ocular Health - Corneal Staining|Corneal staining for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).|1 week|||Eyes|Participants||Number
644892|NCT02196714|Secondary|Change in QTc Fridericia's Interval From Pre-dose to 12 Hours Post Dose|Change in QTc Fridericia's Interval from Pre-dose to 12 hours Post dose|12 hours|Safety Population||msec||Full Range|Mean
644893|NCT02196714|Secondary|Change in QTc Bazett Interval From Pre-dose to 12 Hours Post Dose|Change in QTc Bazett Interval from Pre-dose to 12 hours Post dose|12 hours|Safety Population||msec||Full Range|Mean
644894|NCT02196714|Secondary|Change in QT Interval From Pre-dose to 12 Hours Post Dose|Change in QT Interval from Pre-dose to 12 hours Post dose|12 hours|Safety Population||msec||Full Range|Mean
644895|NCT02196714|Secondary|Change in QRS Duration From Pre-dose to 12 Hours Post Dose|Change in QRS duration from Pre-dose to 12 hours Post dose|12 hours|Safety Population||msec||Full Range|Mean
644896|NCT02196714|Secondary|Change in QRS Axis From Pre-dose to 12 Hours Post Dose|Change in QRS axis from Pre-dose to 12 hours Post dose|12 hours|Safety Population||QRS axis||Full Range|Mean
644908|NCT02196714|Secondary|Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose|Change in Mean Hematology Parameters (±SD) from Pre-dose to 12 Hours Post-dose (Ery. mean corpuscuar volume)|12 Hours|Safety Population||fL||Standard Deviation|Mean
644909|NCT02196714|Secondary|Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose|Change in Mean Hematology Parameters (±SD) from Pre-dose to 12 Hours Post-dose|12 Hours|Safety Population||g/L||Standard Deviation|Mean
644910|NCT02196714|Secondary|Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose|Change in Mean Hematology Parameters (±SD) from Pre-dose to 12 Hours Post-dose|12 Hours|Safety Population||Ratio||Standard Deviation|Mean
644911|NCT02196714|Secondary|Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose|Change in Mean Hematology Parameters (±SD) from Pre-dose to 12 Hours Post-dose|12 Hours|Safety Population||10^9cells/L||Standard Deviation|Mean
644912|NCT02196714|Primary|Lambda z|Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment|Day 1|Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)||1/h||Full Range|Mean
644913|NCT02196714|Primary|Lambda z|Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment|Day 1|Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)||1/h||Full Range|Mean
644914|NCT02196714|Primary|Vd/F|Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment|Day 1|Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)||L||Full Range|Mean
644915|NCT02196714|Primary|Vd/F|Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrroniuml by Treatment|Day 1|Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)||L||Full Range|Mean
644916|NCT02196714|Primary|CL/F|Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment|Day 1|Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)||L/h||Full Range|Mean
644917|NCT02196714|Primary|CL/F|Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment|Day 1|Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)||L/h||Full Range|Mean
644918|NCT02196714|Primary|T 1/2|Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (T 1/2)|Day 1|Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)||h||Full Range|Mean
644919|NCT02196714|Primary|T 1/2|Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (T 1/2)|Day 1|Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)||h||Full Range|Mean
644920|NCT02196714|Primary|Tmax|Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (tmax)|Day 1|Pharmacokinetic Population||h||Full Range|Mean
644921|NCT02196714|Primary|Tmax|Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (tmax)|Day 1|Pharmacokinetic Population||h||Full Range|Mean
644922|NCT02196714|Primary|AUC 0-∞|Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (AUC 0-∞)|Day 1|Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)||h*pg/mL||Full Range|Mean
644923|NCT02196714|Primary|AUC 0-∞|Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (AUC 0-∞)|Day 1|Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)||h*pg/mL||Full Range|Mean
644924|NCT02196714|Primary|AUC 0-t|Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (AUC 0-t)|Day 1|Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)||h*pg/mL||Full Range|Mean
644925|NCT02196714|Primary|AUC 0-t|Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (AUC 0-t)|Day 1|Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)||h*pg/mL||Full Range|Mean
644926|NCT02196714|Primary|AUC 0-12|Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (AUC 0-12)|Day 1|Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)||h*pg/mL||Full Range|Mean
644927|NCT02196714|Primary|AUC 0-12|Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (AUC 0-12)|Day 1|Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)||h*pg/mL||Full Range|Mean
644928|NCT02196714|Primary|Cmax|Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (Cmax)|Day 1|Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)||pg/mL||Full Range|Mean
644929|NCT02196714|Primary|Cmax|Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (Cmax)|Day 1|Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)||pg/mL||Full Range|Mean
644930|NCT02196675|Secondary|Time to Chest Tube Removal|Defined as the number of days from date of surgery to removal of the last chest tube inserted during the surgical procedure.|Post-operative period through hospital discharge and follow-up at Day 30|All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure||days||Standard Deviation|Mean
644931|NCT02196675|Secondary|Volume of Estimated Intra-operative Blood Loss||Blood loss intra-op and up to 5 days post-op|All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure||milliliters||Standard Deviation|Mean
644932|NCT02196675|Secondary|Length of Stay (LOS)|Determined as the length of time in days from hospital admission to initial hospital discharge|Post-operative period through hospital discharge and follow-up at Day 30|All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure and had complete data. One subject was missing the hospital discharge date, thus length of stay could not be calculated.||days||Standard Deviation|Mean
644933|NCT02196675|Secondary|Occurrence of Postoperative Air Leaks|Air leak was to be quantitatively assessed starting on the evening after surgery and then twice daily (during morning and evening rounds). Patients were instructed to perform standardized repeated forced expiratory maneuvers (coughing and blowing).|Post-operative period through hospital discharge and follow-up at Day 30|ll subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure||percentage of participants||95% Confidence Interval|Number
648282|NCT02107014|Primary|Change in IL-5 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].|||pg/mL||95% Confidence Interval|Median
644934|NCT02196675|Primary|Occurrence of Prolonged Air Leaks|Prolonged air leaks defined as longer than 5 days in continuous duration. Air leak was to be quantitatively assessed starting on the evening after surgery and then twice daily (during morning and evening rounds). Patients were instructed to perform standardized repeated forced expiratory maneuvers (coughing and blowing).|Post-operative period through hospital discharge and follow-up at Day 30|All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure||percentage of participants||95% Confidence Interval|Number
644935|NCT02196259|Primary|Functional Connectivity|"The imaging experiments and analysis of subject-specific data will lead to maps corresponding to separate measures: resting state functional connectivity maps. The outcome of interest is whether ketamine reduces functional connectivity between the anterior (subgenual anterior cingulate corte, sgACC) and posterior regions (posterior cingulate cortex, PCC) of the default mode network. This is the z-score of the functional connectivity correlation.
Timepoints for Initial fMRI were: Time 1:Immediately before Infusion, Time 2: After washout (Approx. 40 min after end of infusion).
Timepoints for Depression were: Time 1: 1 Day before Infusion, Time 2: 1 Day after Infusion"|8 minutes scans, acquired between 1 day and 3 days (see above)|Primary outcome measure is functional connectivity as measured using the MRI scans, which is only in the Initial MRI and Depression Arms.||z score||Standard Error|Mean
644936|NCT02196168|Secondary|Progression Free Survival|Estimated in each group by the Kaplan Meier method and differences between groups will be calculated by the log rank test. Hazard ratios for each group will be estimated using the Cox Regression model.|Time from start of treatment to time of progression or death, whichever occurs first, assessed at 12 months|||months||95% Confidence Interval|Median
644937|NCT02196168|Secondary|Progression Free Survival|Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression (20% increase in the sum of the longest diameter of target lesions or a measurable increase in a non-target lesion, or the appearance of new lesions) or death, whichever occurs first.|Time from start of treatment to time of progression or death, whichever occurs first, assessed at 6 months|||months||95% Confidence Interval|Median
644938|NCT02196168|Secondary|Overall Survival|Estimated in each group by the Kaplan Meier method and differences between groups will be calculated by the log rank test. Hazard ratios for each group will be estimated using the Cox Regression model.|12 months|||months||95% Confidence Interval|Median
644939|NCT02196168|Secondary|Levels of Predictive Biomarkers|Predictors of clinical outcomes will be investigated using logistic regression, Cox proportional hazards regression and/or generalized estimating equations as appropriate. Descriptive statistics and plotting of data will be used to better understand potential relationships.|Up to day 4 of course 1|No data are available as decision was made by PI not to do the analysis due to small number of patients.|||||
644940|NCT02196168|Secondary|Levels of Pharmacodynamic Biomarkers|Predictors of clinical outcomes will be investigated using logistic regression, Cox proportional hazards regression and/or generalized estimating equations as appropriate. Descriptive statistics and plotting of data will be used to better understand potential relationships.|Pre-dose, at 4-8 hours on day 3 or 20-24 hours on day 4|No data are available as decision was made by PI not to do the analysis due to small number of patients|||||
644941|NCT02196168|Secondary|Incidence of Adverse Events Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0|Gr 3, Gr 4 and Gr 5 AEs at least possibly related to study drug|Up to 1 year|||adverse events|||Number
644942|NCT02196168|Primary|Overall Response Rate (Complete Plus Partial Response) Using RECIST Criteria v1.1|Per Response Evaluation Criteria in solid Tumors (RECIST1.1) Target lesions are assessed as Complete Response(CR), Disappearance of all target lesions; Partial Response (PR),30% decrease in the sum of the diameters of target lesions; Progressive Disease (PD), At least a 20% increase (minimum 5 mm) from smallest sum (nadir); Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Nontarget lesions are assessed as Complete Response (CR), Disappearance of all non-target lesions; Non-CR/Non-PD, Persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits; Progressive Disease (PD),Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions; Overall Response(OR); PR=CR+non-CR/non-PD,SD=SD+non-PD; PD=PD+presence of any non-target lesions|Up to 1 year|||Participants|||Number
644943|NCT02196077|Secondary|Change From Baseline in Average Daily Use of Rescue Ventolin HFA Over the Last Week of Treatment||Visit 12-13 (7 days)|MITT Population is a subset of the ITT population which includes subjects who received treatment and had post-treatment efficacy data from at least two Treatment Periods||Puffs||95% Confidence Interval|Least Squares Mean
644944|NCT02196077|Secondary|Transition Dyspnea Index (TDI) Focal Score on Day 29|Min/Max Range of TDI scale -9 (major deterioration) to +9 (major improvement)|Day 29|MITT Population is a subset of the ITT population which includes subjects who received treatment and had post-treatment efficacy data from at least two Treatment Periods.||Index||Full Range|Least Squares Mean
644945|NCT02196077|Secondary|Forced Vital Capacity (FVC) AUC0-12 on Day 29||Day 29|MITT Population is a subset of the ITT population which includes subjects who received treatment and had post-treatment efficacy data from at least two Treatment Periods||Liters||95% Confidence Interval|Least Squares Mean
644946|NCT02196077|Secondary|Peak Change From Baseline in FEV1 on Day 1||Day 1|MITT Population is a subset of the ITT population which includes subjects who received treatment and had post-treatment efficacy data from at least two Treatment Periods||Liters||95% Confidence Interval|Least Squares Mean
644947|NCT02196077|Secondary|Peak Change From Baseline in FEV1 (in Liters) Day 29||Day 29|MITT Population is a subset of the ITT population which includes subjects who received treatment and had post-treatment efficacy data from at least two Treatment Periods||Liters||95% Confidence Interval|Least Squares Mean
644948|NCT02196077|Secondary|Peak Change From Baseline in FEV1 (in Liters) Day 15||Day 15|MITT Population is a subset of the ITT population which includes subjects who received treatment and had post-treatment efficacy data from at least two Treatment Periods||Liters||95% Confidence Interval|Least Squares Mean
644949|NCT02196077|Secondary|Change From Baseline in Morning Pre-dose Trough FEV1 Over 28 Days||Over 28 days|MITT Population is a subset of the ITT population which includes subjects who received treatment and had post-treatment efficacy data from at least two Treatment Periods||Liters||95% Confidence Interval|Least Squares Mean
648283|NCT02107014|Primary|Change in IL-4 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].|||pg/mL||95% Confidence Interval|Median
644950|NCT02196077|Primary|FEV1 AUC0-12 on Day 29|Change from Baseline in forced expiratory volume in 1 second (FEV1) area under the curve from 0 to 12 hours (AUC0-12)|Day 29|MITT Population is a subset of the ITT population which includes subjects who received treatment and had post-treatment efficacy data from at least two Treatment Periods.||Liters||95% Confidence Interval|Least Squares Mean
644951|NCT02195986|Secondary|Patient Self-assessment of the Symptoms of Vulvar and Vaginal Atrophy - Superiority to Placebo|Evaluation and comparison between treatment groups of the change from baseline in the most bothersome vulvar and/or vaginal atrophy symptom including vaginal dryness, vaginal and/or vulvar irritation/itching, dysuria, vaginal pain associated with sexual activity, or vaginal bleeding associated with sexual activity as identified by each subject. A score ≤ 1 on Study Day 8 for the most bothersome symptom as identified by the subject at baseline (Study Day -1) was considered a treatment success. A score ≥ 2 on Study Day 8 for the most bothersome symptom as identified by the subject at baseline (Study Day -1) was considered a treatment failure.|Day 8|The Intent-to-treat (ITT) population was used for the Superiority Analysis which consisted of all randomized subjects that used at least one dose of study product and returned for at least one post-baseline visit||Participants|||Count of Participants
644952|NCT02195986|Secondary|Patient Self-assessment of the Symptoms of Vulvar and Vaginal Atrophy - Equivalence|Evaluation and comparison between treatment groups of the change from baseline in the most bothersome vulvar and/or vaginal atrophy symptom including vaginal dryness, vaginal and/or vulvar irritation/itching, dysuria, vaginal pain associated with sexual activity, or vaginal bleeding associated with sexual activity as identified by each subject. A score ≤ 1 on Study Day 8 for the most bothersome symptom as identified by the subject at baseline (Study Day -1) was considered a treatment success. A score ≥ 2 on Study Day 8 for the most bothersome symptom as identified by the subject at baseline (Study Day -1) was considered a treatment failure.|Day 8|The Per Protocol population was used for the secondary endpoint equivalence comparison which consisted of all randomized subjects that were dosed with 75%-125% of scheduled applications and completed secondary endpoint evaluation on Study Day 8 +/- 2 days with no protocol violations that would affect treatment evaluation||Participants|||Count of Participants
644953|NCT02195986|Primary|Primary Endpoint (Vaginal Cytology + Vaginal pH) Superiority to Placebo|"Treatment comparison of the proportion of patients in the Per Protocol (PP) population that were identified as responders at the end of the treatment period on Study Day 8.
A responder was defined as a patient with at least a 25% reduction from baseline in the sum of % basal/parabasal + % intermediate cells on vaginal cytology AND vaginal pH ≤ 5.0 with a change from baseline vaginal pH of at least 0.5."|Study Day 8|The Intent-to-treat (ITT) population was used for the Superiority Analysis which consisted of all randomized subjects that used at least one dose of study product and returned for at least one post-baseline visit.||Participants|||Count of Participants
644954|NCT02195986|Primary|Primary Endpoint (Vaginal Cytology + Vaginal pH) Equivalence|"Treatment comparison of the proportion of patients in the Per Protocol (PP) population that were identified as responders at the end of the treatment period on Study Day 8.
A responder was defined as a patient with at least a 25% reduction from baseline in the sum of % basal/parabasal + % intermediate cells on vaginal cytology AND vaginal pH ≤ 5.0 with a change from baseline vaginal pH of at least 0.5."|Study Day 8|The Per Protocol population was used for the primary endpoint equivalence comparison which consisted of all randomized subjects that were dosed with 75%-125% of scheduled applications and completed primary endpoint evaluation on Study Day 8 +/- 2 days with no protocol violations that would affect treatment evaluation||Participants|||Count of Participants
644955|NCT02195713|Primary|Urine Output of SOC Device Versus Accuryn|Urine output as recorded by the SOC when connected to a standard Foley catheter and standard urinary drainage tube will be compared to urine output recorded by Accuryn and the SOC when connected to a standard Foley catheter and the Accuryn Drainage Tube.|2 - 5 days|||Patients with airlocks||95% Confidence Interval|Number
644956|NCT02195687|Secondary|Percentage of Subjects Achieving None or Mild on the Subject's Assessment of the Severity of Crow's Feet Lines (CFL) at Maximum Smile Using the Facial Wrinkle Scale-Asian (FWS-A)|The subject assessed the severity of their CFLs at maximum smile using the 4-point FWS-A where 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a score of none or mild at Day 30 is reported.|Day 30|Modified Intent-to-Treat: all randomized subjects who received at least 1 injection of study drug||Percentage of Subjects|||Number
644957|NCT02195687|Secondary|Percentage of Subjects Assessing Their Age-related Facial Appearance as Looking Younger on the Self-Perception of Age (SPA) Questionnaire|Subjects assessed their age-related appearance according to the following on the SPA questionnaire: look my current age, look younger, and look older when compared to their baseline assessment. The percentages of subjects who reported looking younger amongst subjects who rated themselves as looking their current age or older at baseline are noted.|Baseline, Day 30|Modified Intent-to-Treat: all randomized subjects who received at least 1 injection of study drug and rated themselves as looking their current age or older at baseline||Percentage of Subjects|||Number
644958|NCT02195687|Secondary|Percentage of Subjects Reporting Their Global Change in Appearance as Very Much Improved or Much Improved Using the 7-point Subject's Global Assessment of Change in CFL (SGA-CFL)|Subjects assessed their global change in appearance using the 7-point SGA-CFL scale where 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse. The percentage of subjects reporting very much improved or much improved are noted.|Day 30|Modified Intent-to-Treat: all randomized subjects who received at least 1 injection of study drug||Percentage of Subjects|||Number
644959|NCT02195687|Secondary|Percentage of Subjects With a ≥ 1-grade Improvement on the Investigator's Assessment of CFL Severity at Maximum Smile on the 4-point FWS-A|The Investigator assessed the severity of the subject's CFLs at maximum smile using the 4-point Facial Wrinkle Scale where 0=none, 1=mild, 2=moderate or 3=severe. The percentages of subjects with at least a 1-grade improvement are noted.|Day 30|Modified Intent-to-Treat: all randomized subjects who received at least 1 injection of study drug||Percentage of Subjects|||Number
644960|NCT02195687|Secondary|Percentage of Subjects With a ≥ 1-grade Improvement on the Investigator's Assessment of CFL Severity at Rest Using the 4-point FWS-A|The Investigator assessed the severity of the subject's CFLs at rest using the 4-point Facial Wrinkle Scale where 0=none, 1=mild, 2=moderate or 3=severe among subjects rated as at least mild at baseline by the Investigator. The percentages of subjects with at least a 1-grade improvement are noted.|Day 30|Modified Intent-to-Treat: all randomized subjects who received at least 1 injection of study drug||Percentage of Subjects|||Number
644961|NCT02195687|Primary|Percentage of Subjects Achieving None or Mild on the Investigator's Assessment of the Severity of Crow's Feet Lines (CFL) at Maximum Smile Using the Facial Wrinkle Scale-Asian (FWS-A)|The Investigator assessed the severity of the subject's CFLs at maximum smile using the 4-point FWS-A where 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a score of none or mild at Day 30 is reported.|Day 30|Modified Intent-to-Treat: all randomized subjects who received at least 1 injection of study drug||Percentage of Subjects|||Number
644962|NCT02195583|Secondary|Percentage Comparative Acid Resistance (% CAR)|Changes in the mineral content of the four centrally-located enamel specimens were evaluated using the SMH Test. The SMH was measured using a Wilson 2100 Hardness Tester. The baseline SMH was measured prior to the in vitro acid challenge. SMH was measured again after the in vitro acid challenge, after the in situ remineralization test, and again after the second in vitro acid challenge. The % CAR was calculated using the equation: % CAR= [(D2-R)/(D1-B)]*100 where B= Indentation length (μm) of sound enamel at baseline; R= Indentation length (μm) of enamel after in situ remineralization; D1= Indentation length (μm) after first acid challenge; D2= Indentation length (μm) after second acid challenge.|Baseline to 4 hours|The main population for the secondary efficacy analysis was the PP population, including participants with a protocol violation affecting some (but not all) of the efficacy assessments. However, data from assessments when a violation occurred were excluded.||Percentage of CAR||Standard Error|Least Squares Mean
644963|NCT02195583|Secondary|Percentage Net Acid Resistance (% NAR)|Changes in the mineral content of the four centrally-located enamel specimens were evaluated using the SMH Test. The SMH was measured using a Wilson 2100 Hardness Tester. The baseline SMH was measured prior to the in vitro acid challenge. SMH was measured again after the in vitro acid challenge, after the in situ remineralization test, and again after the second in vitro acid challenge. The % NAR was calculated using the equation: % NAR= [(D1-D2)/(D1-B)]*100 where B= Indentation length (μm) of sound enamel at baseline; D1= Indentation length (μm) after first acid challenge and D2= Indentation length (μm) after second acid challenge.|Baseline to 4 hours|The main population for the secondary efficacy analysis was the PP population, including participants with a protocol violation affecting some (but not all) of the efficacy assessments. However, data from assessments when a violation occurred were excluded.||Percentage of NAR||Standard Error|Least Squares Mean
644964|NCT02195583|Secondary|Enamel Fluoride Uptake|The microdrill enamel biopsy technique was used to analyze the fluoride uptake by enamel. Each enamel specimen was mounted on the long axis of a drill attached to a microdrill and drilled to a depth of approximately 100 micrometer (μm) through the entire lesion (four cores per specimen). The enamel powder pooled from four drilling sample was then immediately analyzed for fluoride content using fluoride specific electrode and pH/ion meter. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores and expressed as microgram per square centimeter (μg/cm^2).|Baseline to 4 hours|The main population for the secondary efficacy analysis was the PP population, including participants with a protocol violation affecting some (but not all) of the efficacy assessments. However, data from assessments when a violation occurred were excluded.||microgram per square centimeter(μg/cm^2)||Standard Error|Least Squares Mean
644965|NCT02195583|Primary|Percentage Surface Microhardness Recovery (% SMHR)|Changes in the mineral content of the four centrally-located enamel specimens were evaluated using the Surface Microhardness (SMH) Test. The SMH was measured using a Wilson 2100 Hardness Tester. The baseline SMH was determined prior to the in vitro acid challenge. SMH was determined again after the in vitro acid challenge, after the in situ remineralization test, and again after the second in vitro acid challenge. The extent of remineralization was calculated as the % recovery in SMH using the equation: % SMHR= [(D1-R)/(D1-B)]*100 Where B = indentation length (μm) of sound enamel at baseline; D1 = indentation length (μm) after first acid challenge; R = indentation length (μm) after in situ remineralization.|Baseline to 4 hours|The primary population for the efficacy analysis was the Per Protocol (PP) population, including participants with a protocol violation affecting some (but not all) of the efficacy assessments. However, data from assessments when a violation occurred were excluded.||Percentage of SMHR||Standard Error|Least Squares Mean
644966|NCT02195414|Secondary|MSCT Endpoint||3 years||10/2018||||
644967|NCT02195414|Secondary|MSCT Endpoint|mean/minimal vessel area, mean/minimal lumen area, mean/minimal stent area|1 year||10/2016||||
644968|NCT02195414|Secondary|IVUS Endpoint||5 years||10/2020||||
644969|NCT02195414|Secondary|IVUS Endpoint||2 years||10/2017||||
644970|NCT02195414|Secondary|IVUS Endpoint|mean/minimal vessel area, mean/minimal lumen area, mean/minimal stent area|6 months||04/2016||||
644971|NCT02195414|Secondary|OCT Endpoint||5 years||10/2020||||
644972|NCT02195414|Secondary|OCT Endpoint||2 years||10/2017||||
644973|NCT02195414|Secondary|OCT Endpoint|proportion of covered struts, malapposed struts; neointimal hyperplasia (NIH) area, volume; NIH volume obstruction.|6 months||04/2016||||
644974|NCT02195414|Secondary|Angiographic Endpoint||5 years||10/2020||||
644975|NCT02195414|Secondary|Angiographic Endpoint||2 years||10/2016||||
644976|NCT02195414|Secondary|Angiographic Endpoint|In-segment In-scaffold, proximal and distal Late lumen loss (mm); In-segment In-scaffold, proximal and distal Minimal lumen diameter(mm); In-segment In-scaffold, proximal and distal Diameter stenosis (%) Angiographic Binary Restenosis (%).|6 months||04/2016||||
644977|NCT02195414|Secondary|Scaffold Thrombosis||5 years||10/2020||||
644978|NCT02195414|Secondary|Scaffold Thrombosis||4 years||10/2019||||
644979|NCT02195414|Secondary|Scaffold Thrombosis||3 years||10/2018||||
644980|NCT02195414|Secondary|Scaffold Thrombosis||2 years||10/2017||||
644981|NCT02195414|Secondary|Scaffold Thrombosis||1 year||10/2016||||
644982|NCT02195414|Secondary|Scaffold Thrombosis||6 months||04/2016||||
644983|NCT02195414|Secondary|Scaffold Thrombosis|"Scaffold thrombosis will be categorized as acute (≤1day), subacute (>1day ≤30 days) and late (>30 days).
Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion).
In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)* in the distribution of the targetlesion within 30 days."|30days|||participants|||Number
645062|NCT02193074|Secondary|Number of Participants With AEs Corresponding to Changes in Blood Chemistry Values||up to Day 394 (± 7 days) or early termination|Safety Population: all subjects who received ≥ 1 dose of study drug/sham procedure.||participants|||Number
644984|NCT02195414|Secondary|Acute Success (Clinical Device and Clinical Procedure)|"Successful delivery and deployment of the Clinical Investigation scaffold at the intended target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable).
Successful delivery and deployment of the Clinical Investigation scaffold at the intended target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of ischemia driven major adverse cardiac event (MACE) during the hospital stay with a maximum of first seven days post index procedure. In dual lesion setting both lesions must meet clinical procedure success."|acute|||participants|||Number
644985|NCT02195414|Secondary|Patient Oriented Composite Endpoint||5 years||10/2019||||
644986|NCT02195414|Secondary|Patient Oriented Composite Endpoint||4 years||10/2018||||
644987|NCT02195414|Secondary|Patient Oriented Composite Endpoint||3 years||10/2017||||
644988|NCT02195414|Secondary|Patient Oriented Composite Endpoint||2 years||10/2016||||
644989|NCT02195414|Secondary|Patient Oriented Composite Endpoint||1 year||10/2016||||
644990|NCT02195414|Secondary|Patient Oriented Composite Endpoint|Patients oriented composite endpoint includes all-cause death, all myocardial infarction and any revascularization.|6 months||04/2016||||
644991|NCT02195414|Secondary|Patient Oriented Composite Endpoint|Patients oriented composite endpoint includes all-cause death, all myocardial infarction and any revascularization.|30 days|||participants|||Number
644992|NCT02195414|Secondary|Target Lesion Failure||5 years||10/2020||||
644993|NCT02195414|Secondary|Target Lesion Failure||4 years||10/2019||||
644994|NCT02195414|Secondary|Target Lesion Failure||3 years||10/2018||||
644995|NCT02195414|Secondary|Target Lesion Failure||2 years||10/2017||||
644996|NCT02195414|Secondary|Target Lesion Failure||1 year||10/2016||||
644997|NCT02195414|Secondary|Target Lesion Failure|Target lesion failure is a composite endpoint of cardiac death, target vessel related myocardial infarction (TV-MI) and the ischemia-driven target lesion revascularization.|6 months||04/2016||||
644998|NCT02195414|Primary|Target Lesion Failure(TLF)|Target lesion failure is a composite endpoint of cardiac death, target vessel related myocardial infarction (TV-MI) and the ischemia-driven target lesion revascularization.|30 days|||participants|||Number
644999|NCT02194621|Primary|Malodor Bacteria (Breath Odor Causing Bacteria)|Subjects brush their teeth with assigned toothpaste 2x/day for 13 days. On clinic visit day, subjects brush their teeth and return 12 hours later for clinical evaluation. Samples of dental plaque at the gumline will be collected for microbiological analysis to determine levels of mouth odor causing bacteria CFU - colony forming units.|12 hours|||colony forming units||Standard Error|Mean
645000|NCT02194621|Primary|Malodor Bacteria (Breath Odor Causing Bacteria)|Subjects brush their teeth with assigned toothpaste 2x/day for 13 days. On clinic visit day, subjects brush their teeth and return 12 hours later for clinical evaluation. Samples of dental plaque at the gumline will be collected for microbiological analysis to determine levels of mouth odor causing bacteria CFU - colony forming units.|Baseline|||colony forming units||Standard Deviation|Mean
645001|NCT02194621|Primary|Anaerobic Bacteria|Subjects brush their teeth with assigned toothpaste 2x/day for 13 days. On clinic visit day, subjects brush their teeth and return 12 hours later for clinical evaluation. Samples of dental plaque at the gumline will be collected for microbiological analysis to determine total levels of anaerobic bacteria CFU - colony forming units.|12 hours|||colony forming units||Standard Error|Mean
645002|NCT02194621|Primary|Anaerobic Bacteria|Subjects brush their teeth with assigned toothpaste 2x/day for 13 days. On clinic visit day, subjects brush their teeth and return 12 hours later for clinical evaluation. Samples of dental plaque at the gumline will be collected for microbiological analysis to determine total levels of anaerobic bacteria CFU - colony forming units.|Baseline|||colony forming units||Standard Deviation|Mean
645003|NCT02194088|Secondary|Side Effects|The investigators aimed assess if these would be a reason for discontinuation of treatment in a population with mild to moderate pain.Side effects will be assessed with a dichotomous measurement (yes/no)|baseline and 1 hour pain measurement|Participants were analyzed in terms of whether they endorsed or not the side effects (yes/no) Participants were not analyzed in terms of severity degree||Participants|||Count of Participants
645004|NCT02194088|Secondary|Catechol-O-methyltransferase (COMT) Polymorphism Correlation With Pain Relief|Difference in the baseline pain measurements compared to the 1-hour outcome measure will be correlated with Catechol-O-methyltransferase polymorphism|baseline and 1 hour pain measurement|Data were not collected|||||
645005|NCT02194088|Primary|Pain Scores on Standardized Experimental Pain Testing|Pain scores on standardized experimental pain testing, with collection of Visual analog scales (VAS) on a 0-100 scale 0 (no pain)- 100 (worst pain imaginable) Higher values represent a worse outcome (more pain)|baseline and 1 hour pain measurement|||units on a scale||Standard Deviation|Mean
645006|NCT02194062|Secondary|Lund-Kennedy Scoring for Nasal Endoscopy|The Lund Kennedy scoring system for nasal endoscopy rates the severity of the sinusitis based on the endoscopic appearance of the nasal mucosa. Edema, secretions and the presence of polyps are rated from 0-2, for a total maximum score of 6 per each side of the nose. Higher scores represent more severe disease.|6 months post-op|||units on a scale||95% Confidence Interval|Mean
645007|NCT02194062|Primary|SNOT-22 Scores|SNOT22 is a validated scale which measures sinonasal symptoms for sinusitis patients. The 22 questions are rated on a scale of 0-5 for a maximum total score of 110. Higher scores represent more symptomatic patients.|6 months post-op.|||units on a scale||95% Confidence Interval|Mean
645008|NCT02193828|Secondary|Composite Responder Analysis|A composite responder is a subject who had an improved assessment [values of 1 (very much improved), 2 (much improved), or 3 (minimally improved)] on the investigator global assessment and had a satisfied assessment [values of 1 (very satisfied) or 2 (quite satisfied)] on the subject assessment.|Day 57|Analysis based on mITT population; all randomized subjects who received an injection of study medication and had pre- and post-baseline nodule measurements for both ultrasound and calipers.||participants|||Number
645063|NCT02193074|Secondary|Number of Participants With AEs Corresponding to Changes in Hematology Values||up to Day 394 (± 7 days) or early termination|Safety Population: all subjects who received ≥ 1 dose of study drug/sham procedure.||participants|||Number
645009|NCT02193828|Secondary|Subject Satisfaction With Treatment|Subjects were asked to rate their satisfaction with treatment on a 5-point scale: 1 = very satisfied, 2 = quite satisfied, 3 = neither satisfied nor dissatisfied, 4 = quite dissatisfied, and 5 = very dissatisfied.|Day 57|Analysis based on mITT population; all randomized subjects who received an injection of study medication and had pre- and post-baseline nodule measurements for both ultrasound and calipers.||units on a scale||Standard Deviation|Mean
645010|NCT02193828|Secondary|Investigator Global Assessment of Improvement With Treatment|Investigators were asked to determine the degree of improvement in the subject’s treated nodule compared with screening on a 7-point scale: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.|Day 57|Analysis based on mITT population; all randomized subjects who received an injection of study medication and had pre- and post-baseline nodule measurements for both ultrasound and calipers.||units on a scale||Standard Deviation|Mean
645011|NCT02193828|Secondary|Change From Baseline in Nodular Pain of the Treated Nodule at Day 57|After the nodule was squeezed using a dynamometer, subjects were asked to rate the amount of pain they felt on an 11-point visual analog scale (VAS) from 0 (no pain or discomfort) to 10 (extreme pain or discomfort). A negative change from baseline value reflects improvement from baseline (less pain) while a positive value reflects worsening.|Baseline, Day 57|Analysis based on mITT population; all randomized subjects who received an injection of study medication and had pre- and post-baseline nodule measurements for both ultrasound and calipers. Subjects with an incomplete assessment (not done) on Day 57 were excluded.||units on a scale||Standard Deviation|Mean
645012|NCT02193828|Secondary|Percent Change From Baseline in Hardness of the Treated Nodule at Day 57|A durometer was used to assess nodule hardness on a scale of 0 (soft) to 100 (hard). Percent change = 100*(Day 57 hardness - baseline hardness)/baseline hardness. A negative value represents the improvement from baseline (softening) while a positive value represents worsening.|Baseline, Day 57|Analysis based on mITT population; all randomized subjects who received an injection of study medication and had pre- and post-baseline nodule measurements for both ultrasound and calipers. Subjects with an incomplete assessment (not done) on Day 57 were excluded.||percentage of change||Standard Deviation|Mean
645013|NCT02193828|Secondary|Change From Baseline in Consistency of the Treated Nodules at Day 57|Investigators determined the consistency of the nodule through palpitation using a 5-point scale: 5 = hard (solid), 4 = firm throughout, 3 = moderate firmness, 2 = soft, and 1 = non-palpable. The change scores could range from +4 (greatest worsening in consistency) to -4 (greatest improvement in consistency); a negative change from baseline value reflects improvement from baseline (softening) while a positive value reflects worsening.|Baseline, Day 57|Analysis based on mITT population; all randomized subjects who received an injection of study medication and had pre- and post-baseline nodule measurements for both ultrasound and calipers. Subjects with an incomplete assessment (not done) on Day 57 were excluded.||units on a scale||Standard Deviation|Mean
645014|NCT02193828|Secondary|Percent Change From Baseline in Surface Area and Volume of the Treated Nodule at Day 57 Using Ultrasound|Percent change from baseline in surface area and volume of the treated nodule was determined from ultrasound measurements of the length, width, and depth of the nodule. Percent change = 100*(Day 57 area [or volume] - baseline area [or volume])/baseline area [or volume]. A negative value represents the improvement from baseline (decreased size) while a positive value represents worsening.|Baseline, Day 57|Analysis based on mITT population; all randomized subjects who received study medication and had pre- and post-baseline nodule measurements for ultrasound and calipers. Analytical outliers (subjects whose percent change in ultrasound volume was greater than the 75th percentile + 3× the interquartile range) were excluded.||percentage of change||Standard Deviation|Mean
645015|NCT02193828|Primary|Percent Change From Baseline in Surface Area and Volume of the Treated Nodule at Day 57 Using Caliper Measurements|Percent change from baseline in surface area and volume of the treated nodule was determined from hand-held caliper measurements of the length and width of the nodule. Percent change = 100*(Day 57 area [or volume] - baseline area [or volume])/baseline area [or volume]. A negative value represents the improvement from baseline (decreased size) while a positive value represents worsening.|Baseline, Day 57|Analysis based on Modified Intent-to-Treat (mITT) population; all randomized subjects who received study medication and had pre- and post-baseline nodule measurements for ultrasound and calipers. Analytical outliers (subjects whose percent change in ultrasound volume was greater than the 75th percentile + 3× the interquartile range) were excluded.||percentage of change||Standard Deviation|Mean
645016|NCT02193815|Other Pre-specified|Number of Participants With Potentially Clinically Significant Vital Signs Findings|Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: supine/sitting pulse rate <40 or >120 beats per minute (bpm), standing pulse rate <40 or >140 bpm; systolic blood pressure (SBP) >=30 millimeters of mercury (mmHg) change from baseline in same posture or SBP <90 mmHg, diastolic blood pressure (DBP) >=20 mmHg change from baseline in same posture or DBP <50 mmHg.|Baseline up to Day 12|The safety population included all enrolled participants who received at least 1 dose of investigational product.||participants|||Number
645017|NCT02193815|Other Pre-specified|Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern|The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell [RBC] count, RBC morphology, platelet count, white blood cell [WBC] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen [BUN], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, alkaline phosphatase, uric acid, albumin, and total protein; urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, microscopy [if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase]); others (e.g., urine human chorionic gonadotropin [hCG] for females of childbearing potential).|Baseline up to Day 12|The safety population included all enrolled participants who received at least 1 dose of investigational product.||participants|||Number
645060|NCT02193074|Secondary|Summary of Shifts in 12-lead Electrocardiogram (ECG) Results|Shift to ‘abnormal, not clinically significant’ includes ‘unknown’ or ‘normal’ to ‘abnormal, not clinically significant’. Shift to ‘abnormal, clinically significant’ includes ‘unknown’ or ‘normal’ to ‘abnormal, clinically significant’.|up to Day 394 (± 7 days) or early termination|Safety Population: all subjects who received ≥ 1 dose of study drug/sham procedure and whose baseline value was not abnormal and who had at least one post-baseline value.||participants|||Number
645018|NCT02193815|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Specified Skin AEs|An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs. The number of participants with specified skin AEs was reported.|Baseline up to 28 days after last study drug administration (Day 21)|The safety population included all enrolled participants who received at least 1 dose of investigational product.||participants|||Number
645019|NCT02193815|Secondary|Global Clinical Assessment at Day 1, 8 and 12|"Global Clinical Assessment of the test fields was performed by visual examination using a 5-point score (-1=worsened; 0=unchanged [no effect]; 1=slight improvement; 2=clear improvement but not completely healed; 3=completely healed). Clinically apparent differences in erythema and infiltration will contribute to this global assessment. At baseline (Day 1), the score was documented as 0 (unchanged)."|Day 1, Day 8, Day 12|The ITT population included all participants who had investigational products dispensed and had at least 1 post-baseline assessment of the primary efficacy variable.||participants|||Number
645020|NCT02193815|Secondary|Area Under the Curve (AUC) of Psoriatic Skin Thickness/EPB|The AUC of psoriatic skin thickness/EPB from Day 1 to Day 12 was determined using the linear trapezoidal rule. The mean raw values are reported.|Day 1 (baseline) up to Day 12|The ITT population included all participants who had investigational products dispensed and had at least 1 post-baseline assessment of the primary efficacy variable.||micrometers*day||Standard Deviation|Mean
645021|NCT02193815|Secondary|Change From Baseline in Psoriatic Skin Thickness/EPB at Day 8||Day 1 (Baseline), Day 8|The ITT population included all participants who had investigational products dispensed and had at least 1 post-baseline assessment of the primary efficacy variable.||micrometers||Standard Deviation|Mean
645022|NCT02193815|Secondary|Change From Baseline in Psoriatic Skin Thickness/EPB for Tofacitinib 2% Ointment in Comparison to Corresponding Vehicle at Day 12||Day 1 (Baseline), Day 12|The ITT population included all participants who had investigational products dispensed and had at least 1 post-baseline assessment of the primary efficacy variable.||micrometers||Standard Deviation|Mean
645023|NCT02193815|Secondary|Change From Baseline in Psoriatic Skin Thickness/EPB for PF-06263276 4% Solution in Comparison to Daivonex Solution at Day 12||Day 1 (Baseline), Day 12|The ITT population included all participants who had investigational products dispensed and had at least 1 post-baseline assessment of the primary efficacy variable.||micrometers||Standard Deviation|Mean
645024|NCT02193815|Primary|Change From Baseline in Psoriatic Skin Thickness/Echo-Poor Band (EPB) for PF-06263276 4% Solution in Comparison to Corresponding Vehicle at Day 12|Psoriatic skin thickness was measured using a 20 megahertz (MHz) high frequency sonograph. Serial A-scans were composed and presented on a monitor as a section of the skin.|Day 1 (Baseline), Day 12|The Intent-to-Treat (ITT) population included all participants who had investigational products dispensed and had at least 1 post-baseline assessment of the primary efficacy variable.||micrometers||Standard Deviation|Mean
645025|NCT02193178|Primary|Investigator Acceptability|Investigator's preference on acceptability of refitting subjects in to comfilcon A lens based on lens performance assessed at baseline and 2 weeks.Scale 1-5, 1=Strongly agree, 5=Strongly disagree.|Baseline and 2 weeks|||percentage of subjects|||Number
645026|NCT02193178|Primary|Overall Preference|Overall subjective preference between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses|Baseline and 2 weeks|||percentage of subjects|||Number
645027|NCT02193178|Primary|Preference - Handling|Subjective preference for handling between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses|Baseline and 2 weeks|Missing data for handling preference for one participant.||percentage of subjects|||Number
645028|NCT02193178|Primary|Preference - Vision|Subjective preference for vision between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses|Baseline and 2 weeks|||percentage of subjects|||Number
645029|NCT02193178|Primary|Subjective Preference - Comfort|Subjective preference for comfort between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses|Baseline and 2 weeks|||percentage of subjects|||Number
645030|NCT02193178|Primary|Visual Acuity|Visual acuity for habitual lenses assessed 2 weeks prior to baseline and for comfilcon A assessed at baseline and 2 weeks post baseline using logMAR.|2 weeks prior to baseline, Baseline, 2 weeks post baseline|One participant discontinued and therefore data was not included in analysis.||LogMAR||Standard Deviation|Mean
645031|NCT02193178|Primary|Anterior Ocular Health - Conjunctival Staining and Indentation|Conjunctival staining and indentation for comfilcon A lenses assessed at baseline and 2 weeks. Conjuctival staining scale 0-4, 0=None, 4=Severe|Baseline and 2 weeks|||units on a scale|eyes|Standard Deviation|Mean
645032|NCT02193178|Primary|Anterior Ocular Health - Corneal Staining|Corneal staining for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=No staining; 4= >45% of area|Baseline and 2 weeks|||units on a scale|eyes|Standard Deviation|Mean
645033|NCT02193178|Primary|Anterior Ocular Health - Bulbar and Limbal Redness|Bulbar and limbal redness for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=None; 4=Severe injection|Baseline and 2 weeks|||units on a scale|eyes|Standard Deviation|Mean
645034|NCT02193178|Primary|Anterior Ocular Health - Palpebral Hyperemia and Roughness|Palpebral hyperemia and roughness for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=None, 4=Severe|Baseline and 2 weeks|||units on a scale|eyes|Standard Deviation|Mean
645035|NCT02193178|Primary|Lens Fit Acceptance|General lens fit acceptance for habitual lenses assessed 2 weeks prior to baseline and refitted with comfilcon A lenses, which were assessed at baseline and at 2 weeks. (Scale 0-4, 0=Can't be worn; 4=Optimum)|2 weeks prior to baseline, Baseline, 2 weeks post baseline|One participant discontinued and therefore data was not included in analysis. Another participant did not wear habitual lens and therefore data was not collected for habitual lenses.||units on a scale|eyes|Standard Deviation|Mean
645036|NCT02193178|Primary|Lens Fit - Overall Stability|Lens Fit (stability) for habitual lenses assessed 2 weeks prior to baseline and then refitted with comfilcon A lenses. After refitting with comfilcon A lenses, stability was assessed at baseline and 2 weeks. Scale 0-4, 0=Totally unstable, can't be worn to provide acceptable vision correction for an astigmatism, 4=Excellent orientation and optimum rotational recovery and stability|2 weeks prior to baseline, Baseline, 2 weeks post baseline|One participant discontinued and therefore data was not included in analysis. Another participant did not wear habitual lens and therefore data was not collected for habitual lenses.||units on a scale|eyes|Standard Deviation|Mean
645037|NCT02193178|Primary|Lens Fit - Rotation|Lens Fit (rotation) for habitual lenses were assessed 2 weeks prior to baseline and then refitted with comfilcon A lenses. After refitting with comfilcon A, lens fit rotation was assessed at baseline and 2 weeks. Lens rotation was measured within 10 degrees of the desired 6 o'clock position. Scale 0-180 degrees, 0=no rotation, 180=max rotation.|2 weeks prior to baseline, Baseline, 2 weeks post baseline|One participant discontinued and therefore data was not included in analysis. Another participant did not wear habitual lens and therefore data was not collected for habitual lenses.||percentage of eyes|eyes||Number
645038|NCT02193178|Primary|Overall Satisfaction|Subjective ratings for overall satisfaction for habitual lenses assessed 2 weeks prior to baseline and overall satisfaction for comfilcon A assessed at baseline and 2 weeks post baseline. Scale 0-100, 0=Extremely dissatisfied, 100=Extremely satisfied.|2 weeks prior to baseline, Baseline, 2 weeks post baseline|One participant discontinued and therefore data was not included in analysis.||units on a scale||Standard Deviation|Mean
645039|NCT02193178|Primary|Handling|Subjective ratings for handling for habitual lenses assessed 2 weeks prior to baseline and handling for comfilcon A assessed at baseline and 2 weeks post baseline. Scale 0-100, 0=Very difficult, 100=Very easy|2 weeks prior to baseline, Baseline, 2 weeks post baseline|One participant discontinued and therefore data was not included in analysis.||units on a scale||Standard Deviation|Mean
645040|NCT02193178|Primary|Overall Vision|Subjective ratings for overall vision for habitual lenses assessed 2 weeks prior to baseline and vision for comfilcon A assessed at baseline and 2 weeks post.Scale 0-100, 0=Extremely poor vision all of the time, cannot function, 100=Excellent vision all of the time.|2 weeks prior to baseline, Baseline, 2 weeks post|One participant discontinued and therefore data was not included in analysis.||units on a scale||Standard Deviation|Mean
645041|NCT02193178|Primary|Overall Comfort|Subjective ratings for overall comfort for habitual lenses assessed 2 weeks prior to baseline and for comfilcon A lenses assessed at baseline and 2 weeks post baseline. Scale 0-100, 0=cannot be worn, causes pain, and 100=cannot be felt ever.|2 weeks prior to baseline, Baseline, 2 weeks post baseline|One participant discontinued and therefore data was not included in analysis.||units on a scale||Standard Deviation|Mean
645042|NCT02193165|Primary|Gingivitis Scores|Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)|6 weeks|||units on a scale||Standard Deviation|Mean
645043|NCT02193165|Primary|Gingivitis Scores|Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)|4 weeks|||units on a scale||Standard Deviation|Mean
645044|NCT02193165|Primary|Gingivitis Scores|Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)|Baseline|||units on a scale||Standard Deviation|Mean
645045|NCT02193165|Primary|Dental Plaque Scores|Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|6 weeks|||units on a scale||Standard Deviation|Mean
645046|NCT02193165|Primary|Dental Plaque Scores|Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|4 weeks|||units on a scale||Standard Deviation|Mean
645047|NCT02193165|Primary|Dental Plaque Scores|Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|Baseline|||units on a scale||Standard Deviation|Mean
645048|NCT02193087|Secondary|Percentage of Participants With Markedly Abnormal Laboratory Values in the Safety Sub-Set|Percentage of participants with markedly abnormal standard safety laboratory values collected at any time after the first vaccination.|Days 8, 15, 91, 97 and 104|"The Safety Laboratory Sub-Set included randomly chosen participants from each treatment group for whom samples for clinical safety lab tests were collected and who received at least one vaccination dose. n in each of the categories is the number of participants with data available at the given time-point."||percentage of participants|||Number
645049|NCT02193087|Secondary|Percentage of Participants With Serious Adverse Events (SAEs)|A serious adverse event (SAE) is defined as any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.|Up to 6 Months after the last dose (9 months)|SS included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose.||percentage of participants|||Number
646826|NCT02138097|Secondary|Proportion of Days Covered for United Healthcare Patients|Number of days supply dispensed divided by number of days followed|up to 12 months|All patients in United Healthcare cohort||days covered||Standard Deviation|Mean
645050|NCT02193087|Secondary|Percentage of Participants With Any Unsolicited Adverse Events (AEs)|Unsolicited AEs are any AEs that are not solicited local or systemic AEs, as defined by this study, that occurred at least once within 28 days after either vaccination. An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. The investigator assessed whether the AE was related to the study vaccination.|Up to Day 28 after each vaccination|SS included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose.||percentage of participants|||Number
645051|NCT02193087|Secondary|Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity|The percentage of participants with solicited systemic AEs of varying severity are reported. Solicited systemic AEs are defined as asthenia, fever, headache, malaise, and myalgia that occurred at least once within 14 days after either vaccination, as recorded by the participants in a diary. Participants with multiple episodes are categorized using the highest severity level. Percentages are based on the number of participants with diary data available.|Days 1 through 14 after each vaccination|Participants from the SS with evaluable data and who received at least 1 dose of study vaccine (or placebo), including a partial dose.||percentage of participants|||Number
645052|NCT02193087|Secondary|Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity|The percentage of participants with solicited local AEs at injection site of varying severity are reported. Solicited local AEs are defined as pain, erythema and swelling that occurred at least once within 7 days after either vaccination, as recorded by the participants in a diary. Participants with multiple episodes are categorized using the highest severity level. Percentages are based on the number of participants with diary data available.|Days 1 through 7 after each vaccination|Participants from the SS with evaluable data and who received at least 1 dose of study vaccine (or placebo), including a partial dose. “n” in each of the categories is the number of participants with data available for analysis.||percentage of participants|||Number
645053|NCT02193087|Secondary|Percentage of Participants With Solicited Systemic Adverse Events (AEs)|Solicited systemic AEs are defined as asthenia, fever, headache, malaise, and myalgia that occurred at least once within 14 days after either vaccination, as recorded by the participants in a diary. Percentages are based on the number of participants with diary data available.|Days 1 through 14 after each vaccination|Participants from the SS with evaluable data and who received at least 1 dose of study vaccine (or placebo), including a partial dose.||percentage of participants|||Number
645054|NCT02193087|Secondary|Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs)|Solicited local AEs at injection site are defined as pain, erythema and swelling that occurred at least once within 7 days after either vaccination, as recorded by the participants in a diary. Percentages are based on the number of participants with diary data available.|Days 1 through 7 after each vaccination|Participants from the Safety Set (SS) with evaluable data and who received at least 1 dose of study vaccine (or placebo), including a partial dose. “n” in each of the categories is the number of participants with data available for analysis.||percentage of participants|||Number
645055|NCT02193087|Secondary|Percentage of Participants With a Seropositive Response for Each of the Four Dengue Serotypes Comparing Group D With Group B|A seropositive response is defined as a reciprocal neutralizing titer ≥ 10. The four dengue serotypes are DEN-1, DEN-2, DEN-3 and DEN-4.|Months 1 and 4|PPS included all randomized participants who received the planned number of investigational vaccine doses, had serology data at Baseline and Month 1 and had no major protocol violations. Participants seropositive at Baseline are not included. “n” in each of the categories is the number of participants with data available at the given time-point.||percentage of participants||95% Confidence Interval|Number
645056|NCT02193087|Secondary|Percentage of Participants With a Seropositive Response for Each of the Four Dengue Serotypes Comparing Group D With Groups A and B Combined|A seropositive response is defined as a reciprocal neutralizing titer ≥ 10. The four dengue serotypes are DEN-1, DEN-2, DEN-3 and DEN-4.|Month 1|Per-Protocol Set (PPS) included all randomized participants who received the planned number of investigational vaccine doses, had serology data at Baseline and Month 1, and have no major protocol violations. Participants seropositive at Baseline are not included.||percentage of participants||95% Confidence Interval|Number
645057|NCT02193087|Secondary|Geometric Mean Titers (GMT) of Neutralizing Antibodies for Each of the Four Dengue Serotypes Comparing Group D With Group B|Geometric mean titer (GMT) of neutralizing antibodies for each of the four dengue serotypes as measured by Plaque Reduction Neutralization Test resulting in 50% reduction in Plaques (PRNT50). The four dengue serotypes are DEN-1, DEN-2, DEN-3 and DEN-4. ANOVA model for the natural log-transformed GMT at month 1 with study group as a factor was used for analysis.|Months 1 and 4|"PPS included all randomized participants who received the planned number of investigational vaccine doses, had serology data at Baseline and Month 1 and had no major protocol violations. Participants seropositive at Baseline are not included. n in each of the categories is the number of participants with data available at the given time-point."||titer||90% Confidence Interval|Least Squares Mean
645058|NCT02193087|Primary|Geometric Mean Titer (GMT) of Neutralizing Antibodies for Each of the Four Dengue Serotypes Comparing Group D To Groups A and B Combined|"Geometric mean titer (GMT) of neutralizing antibodies for each of the four dengue serotypes as measured by Plaque Reduction Neutralization Test resulting in 50% reduction in Plaques (PRNT50). The four dengue serotypes are DEN-1, DEN-2, DEN-3 and DEN-4.
A 90% Confidence Interval (CI) for the ratio of GMT (or equivalently the difference of the log transformed GMT) was provided, for each serotype, for the comparison of the lyophilized formulation (Group D) versus the liquid formulation 1 (Groups A+B combined). An Analysis of Variance (ANOVA) model for the natural log-transformed GMT at month 1 with study group as a factor was used for analysis."|Month 1|Per-Protocol Set (PPS) included all randomized participants who received the planned number of investigational vaccine doses, had serology data at Baseline and Month 1 and had no major protocol violations. Participants seropositive at Baseline are not included.||titer||90% Confidence Interval|Least Squares Mean
645059|NCT02193074|Secondary|Number of Participants With Clinically Significant Changes From Baseline in Urinalysis Values||up to Day 394 (± 7 days) or early termination|Safety Population: all subjects who received ≥ 1 dose of study drug/sham procedure.||participants|||Number
645061|NCT02193074|Secondary|Number of Participants Meeting Selected Vital Sign Criteria Post-Baseline||up to Day 394 (± 7 days) or early termination|Safety Population: all subjects who received ≥ 1 dose of study drug/sham procedure and had an assessment.||participants|||Number
645064|NCT02193074|Secondary|Number of Participants Experiencing Adverse Events (AEs), Serious AEs (SAEs) and Discontinuations Due to AEs|AE: any unfavorable and unintended sign, symptom, or disease temporally associated with the study or use of investigational drug product, whether or not the AE is considered related to the investigational drug product. SAE: any AE that in the view of either the Investigator or Sponsor, meets any of the following criteria: results in death; is life threatening: that is, poses an immediate risk of death at the time of the event; requires in-patient hospitalization or prolongation of existing hospitalization; results in a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; results in congenital anomaly or birth defect in the offspring of the participant (whether male or female); is an important medical event in the opinion of the Investigator or Sponsor.|Screening through Day 394 (± 7 days) or early termination|Safety Population: all subjects who received ≥ 1 dose of study drug/sham procedure.||participants|||Number
645065|NCT02193074|Secondary|Time to Death or Permanent Ventilation in the Subgroup of Participants Above the Study Median Disease Duration|Estimated proportion of participants who died or required permanent ventilation (EAC-adjudicated events) among participants above the study median disease duration (13.1 weeks), by given duration thresholds, based on the Kaplan-Meier product-limit method.|Day 91, Day 182, Day 273, Day 364, Day 394|Intent-to-treat population: all randomized participants who received ≥ 1 dose of study drug/sham procedure and were above the study median disease duration.||proportion of participants|||Number
645066|NCT02193074|Secondary|Time to Death or Permanent Ventilation in the Subgroup of Participants Below the Study Median Disease Duration|Estimated proportion of participants who died or required permanent ventilation (EAC-adjudicated events) among participants below the study median disease duration (13.1 weeks), by given duration thresholds, based on the Kaplan-Meier product-limit method.|Day 91, Day 182, Day 273, Day 364, Day 394|Intent-to-treat population: all randomized participants who received ≥ 1 dose of study drug/sham procedure and were below the study median disease duration.||proportion of participants|||Number
645067|NCT02193074|Secondary|Percentage of Compound Muscular Action Potential (CMAP) Responders|CMAP is an electrophysiological technique that can be used to determine the approximate number of motor neurons in a muscle or group of muscles. A participant was defined as a CMAP responder if the CMAP amplitude at the peroneal nerve was increasing to or maintained at ≥ 1 mV (comparing to the baseline) based on assessment at the later of the Day 183, Day 302, or Day 394 study visits. Results are based on all available data.|assessed at the later of the Day 183, Day 302, or Day 394 study visits|Intent-to-treat population: all randomized participants who received ≥ 1 dose of study drug/sham procedure with Day 183, Day 302, or Day 394 data; the last available assessment was used. (Participants who died or withdrew from the study were counted as non-responders and were included in the denominator for the calculation of the percentages.)||percentage of participants|||Number
645068|NCT02193074|Secondary|Percentage of Participants Not Requiring Permanent Ventilation||Up to Day 394|Intent-to-treat population: all randomized participants who received ≥ 1 dose of study drug/sham procedure.||percentage of participants|||Number
645069|NCT02193074|Secondary|Summary of Time to Death|Estimated proportion of participants who died by given duration thresholds, based on the Kaplan-Meier product-limit method.|Day 91, Day 182, Day 273, Day 364, Day 394|Intent-to-treat population: all randomized participants who received ≥ 1 dose of study drug/sham procedure and who died. Results are based on all available data.||proportion of particiants|||Number
645070|NCT02193074|Secondary|Percentage of Children’s Hospital of Philadelphia Infant Test of Neuromuscular Disorders (CHOP-INTEND) Responders|A participants was considered a CHOP-INTEND responder if the change from baseline in CHOP-INTEND total score is ≥ 4 points based on assessment at the later of the Day 183, Day 302, or Day 394 study visits. CHOP-INTEND tests includes 16 items structured to move from easiest to hardest with the grading including gravity eliminated (lower scores) to antigravity movements (higher scores). Total scores range from 0 to 64, with higher scores indicating better movement functioning. Results are based on all available data.|assessed at Baseline and the later of the Day 183, Day 302, or Day 394 study visits|Intent-to-treat population: all randomized participants who received ≥ 1 dose of study drug/sham procedure with Day 183, Day 302, or Day 394 data; the last available assessment was used. (Participants who died or withdrew from the study were counted as non-responders and were included in the denominator for the calculation of the percentages.)||percentage of participants|||Number
645071|NCT02193074|Primary|Time to Death or Permanent Ventilation|Estimated proportion of participants who died or required permanent ventilation by a given study day, based on the Kaplan-Meier product-limit method. Time to death or permanent ventilation was defined as either tracheostomy or ≥ 16 hours ventilation/day continuously for > 21 days in the absence of an acute reversible event. This endpoint was adjudicated by a blinded, independent group of experienced clinicians, the Event Adjudication Committee (EAC), based on review of clinical study data and supporting information. Results are based on all available data.|Day 91, Day 182, Day 273, Day 364, Day 394|Intent-to-treat population: all randomized participants who received ≥ 1 dose of study drug/sham procedure and who died or required permanent ventilation.||proportion of participants|||Number
645072|NCT02193074|Primary|Percentage of Motor Milestones Responders|"The definition of a motor milestones responder was based on improvement in the motor milestones categories in Section 2 of the Hammersmith Infant Neurological Examination (HINE), with the exclusion of voluntary grasp, as follows:
(i) subject demonstrates ≥ 2-point increase in the motor milestones category of ability to kick or achievement of maximal score on that category (touching toes), or a 1-point increase in the motor milestones category of head control, rolling, sitting, crawling, standing, or walking, and (ii) among the motor milestone categories, with the exclusion of voluntary grasp, there are more categories where there is improvement as defined in (i) than worsening. (For the category of ability to kick, worsening is defined as ≥ 2-point decrease or decrease to the lowest possible score of no kicking. For the other categories, worsening is defined as ≥ 1-point decrease.) The lowest possible score for the HINE is 0 (zero), and the highest possible score for the HINE is 28."|assessed at the later of the Day 183, Day 302, or Day 394 study visits|Intent-to-treat population: all randomized participants who received ≥ 1 dose of study drug/sham procedure with Day 183, Day 302, or Day 394 data; the last available assessment was used. (Participants who died or withdrew from the study were counted as non-responders and were included in the denominator for the calculation of the percentages.)||percentage of participants|||Number
648284|NCT02107014|Primary|Change in IL-2 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].|||pg/mL||95% Confidence Interval|Median
645073|NCT02192879|Other Pre-specified|Serious Adverse Events Associated With Regional Catheter Placement|Serious adverse events in the 2 arms with regional catheters (TEA and PVB) will be monitored|postoperatively until removal of regional catheter removed, with an average of 3 days up to 7 days|only patients who had a catheter||serious adverse events|||Number
645074|NCT02192879|Secondary|Highest VAS Pain Scores With Coughing|Post-operative pain scores with coughing, as assessed by Pain Assessment Scales (Wong-Baker Faces Scale and Visual Analog Pain Scale (VAS) will be measured. Pain score is from 0 (no hurt) to 10 (hurts worst).|postoperatively until regional catheter removed, with an expected average of 3 days and up to 7 days|||units on a scale||Standard Deviation|Mean
645075|NCT02192879|Secondary|Incidence of Major Postoperative Complication|Major surgical, infectious, respiratory, cardiac, and renal complications will be recorded for subjects in each arm of the study.|time to discharge after surgery, with an expected average of approximately 7-10 days, up to 6 weeks if complications arise|||complications|||Number
645076|NCT02192879|Secondary|Cumulative Postoperative Opioid Requirement|Cumulative postoperative opioid use in morphine equivalents will be recorded for subjects in the 3 arms of the study. The investigators hypothesize that the TEA and/or PVB arms may show less opioid use over PCA.|postpoperatively until regional catheter removed or subjects transitioned to an oral pain management regimen, an expected average of 3 days and up to 7 days|||mg||Standard Deviation|Mean
645077|NCT02192879|Secondary|Gastrointestinal Recovery|Postoperative return of bowel function and time to first feeding will be recorded for each of the 3 groups.|postoperatively until return of bowel function, up to 7 days|||days||Standard Deviation|Mean
645078|NCT02192879|Secondary|Hospital Length of Stay|Hospital length of stay will be recorded for each of the 3 groups to see if there is a statistical difference between groups.|time to discharge after surgery, with an expected average of approximately 7-10 days, up to 6 weeks if complications arise|||days||Standard Deviation|Mean
645079|NCT02192879|Primary|Highest VAS Pain Score at Rest|Post-operative pain scores at rest, as assessed by Pain Assessment Scales (Wong-Baker Faces Scale and Visual Analog Pain Scale (VAS) will be the primary outcome measured. Pain scores will be collected per standard PACU protocol (every 60 minutes) and on the hospital ward at hours 2, 4, 6 and 12, and then daily until day 3 or when the epidural/paravertebral catheter is removed. Postoperative pain at rest will be defined as the highest VAS pain score reported by each patient at any time. Pain score is from 0 (no hurt) to 10 (hurts worst).|postoperatively until regional catheter removed, with an expected average of 3 days and up to 7 days|||units on a scale||Standard Deviation|Mean
645080|NCT02192814|Other Pre-specified|The Cumulative Partial-onset Seizure Frequency From Day -1 to Day 5|No descriptive statistics have been calculated for this exploratory Outcome Measure.|From Day -1 to Day 5||||||
645081|NCT02192814|Secondary|Maximum Plasma Concentration (Cmax) for Lacosamide (LCM) (End of Infusion) on Day 5||20 minutes prior infusion at Day 5|The Safety Set (SS) consisted of all enrolled subjects who received at least 1 infusion of iv LCM.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
645082|NCT02192814|Secondary|Maximum Plasma Concentration (Cmax) for Lacosamide (LCM) (End of Infusion) on Day 2||20 minutes prior infusion at Day 2|The Safety Set (SS) consisted of all enrolled subjects who received at least 1 infusion of iv LCM.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
645083|NCT02192814|Secondary|Maximum Plasma Concentration (Cmax) for Lacosamide (LCM) (End of Infusion) on Day 1||20 minutes prior infusion at Day 1|The Safety Set (SS) consisted of all enrolled subjects who received at least 1 infusion of iv LCM.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
645084|NCT02192814|Secondary|Plasma Trough Concentration (Ctrough) for Lacosamide (LCM) on Day 5||20 minutes prior infusion at Day 5|The Safety Set (SS) consisted of all enrolled subjects who received at least 1 infusion of iv LCM.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
645085|NCT02192814|Secondary|Plasma Trough Concentration (Ctrough) for Lacosamide (LCM) on Day 2||20 minutes prior infusion at Day 2|The Safety Set (SS) consisted of all enrolled subjects who received at least 1 infusion of iv LCM.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
645086|NCT02192814|Secondary|Plasma Trough Concentration (Ctrough) for Lacosamide (LCM) on Day 1||20 minutes prior infusion at Day 1|The Safety Set (SS) consisted of all enrolled subjects who received at least 1 infusion of iv LCM.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
645087|NCT02192814|Primary|The Total Number of Subject Withdrawal Due to Adverse Events During the Study|An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|During the study (Screening through End of Study (Day -1 through Day 6))|The Safety Set (SS) consisted of all enrolled subjects who received at least 1 infusion of iv LCM.||participants|||Number
645088|NCT02192814|Primary|The Total Number of Subjects Experiencing at Least One Adverse Event During the Study|An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|During the study (Screening through End of Study (Day -1 through Day 6))|The Safety Set (SS) consisted of all enrolled subjects who received at least 1 infusion of iv LCM.||participants|||Number
645089|NCT02192684|Primary|Change in Apnea-hypopnea Index (AHI) Outcome Measure in Response to Pioglitazone or Placebo|To evaluate the effects of pioglitazone versus placebo on AHI in patients with OSA.|8 weeks|||AHI events/hour||Inter-Quartile Range|Median
645090|NCT02192606|Secondary|Estimated Blood Loss at the Time of Total Laparoscopic Hysterectomy|The secondary endpoint is the surgeon estimated blood loss at the time of a total laparoscopic hysterectomy.|Time of Procedure End|||millileters||Standard Deviation|Mean
645166|NCT02189252|Secondary|Baseline-adjusted AUC0-24 for Plasma Total DPA||participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.|PK Population||hr*ug/mL||Geometric Coefficient of Variation|Geometric Mean
648285|NCT02107014|Primary|Change in IL-1Ra From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].|||pg/mL||95% Confidence Interval|Median
645091|NCT02192606|Primary|Vaginal Cuff Closure Times|The primary endpoint is the vaginal cuff closure time at the time of a total laparoscopic hysterectomy. As the 2D laparoscopy system is standard during laparoscopic cases, our objective is to assess if there is a difference in vaginal cuff closure time when a 3D laparoscopy system is used instead. At time of the surgery, that patient will be randomized to either system. A resident or fellow will close the vaginal cuff and time to close the vaginal cuff will be recorded.|Start of vaginal cuff closure to end of vaginal cuff closure|||minutes||Standard Deviation|Mean
645092|NCT02192164|Other Pre-specified|Smoking Habit Questionnaire: Mean Duration of Smoking Among Participants|Smoking habit questionnaire which was conducted on Day 1, assessed the data on smoking which included the mean duration (in years) of smoking among participants. Former smokers were defined as those participants who had stopped smoking at least 1 year prior to the study.|Day 1|All treated participants with available post-baseline documentation. Here, ‘N’ signifies those participants who were evaluable for this measure. Data for this outcome measure was planned to be analyzed in smokers and former smokers.||years||Standard Error|Mean
645093|NCT02192164|Other Pre-specified|Smoking Habit Questionnaire: Mean Age of Participants at Which Cigarette Smoking Started and Quitted|Smoking habit questionnaire that was conducted on Day 1, assessed the data on smoking which included the age of participants at which they started smoking and the age at which they quitted smoking. Former smokers were defined as those participants who had stopped smoking at least 1 year prior to the study.|Day 1|All treated participants with available post-baseline documentation. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies those participants who were evaluable for each arm. Data for this outcome measure was planned to be analyzed in smokers and former smokers.||years||Standard Error|Mean
645094|NCT02192164|Other Pre-specified|Smoking Habit Questionnaire: Smoking Status of Participants|Smoking habit questionnaire that was conducted on Day 1, assessed the data on smoking status of participants. Smoking status of participants was classified as never smoked, current smokers, and former smokers. Former smokers were defined as those participants who had stopped smoking at least 1 year prior to the study.|Day 1|All treated participants with available post-baseline documentation.||participants|||Number
645095|NCT02192164|Secondary|Percent Change From Baseline in Psoriasis Assessment and Severity Index (PASI) at Week 12 and 24|Percentage improvement in PASI score from baseline was calculated at Week 12 and 24 in terms of percent change from baseline. PASI score is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck [h], arms [u], trunk [t], legs [l]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated: 0 (no involvement) to 6 (90–100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4.|Baseline, Week 12, 24|All treated participants with available post-baseline documentation.||percent change||Standard Deviation|Mean
645096|NCT02192164|Secondary|Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12 and 24|PASI score is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck [h], arms [u], trunk [t], legs [l]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated: 0 (no involvement) to 6 (90–100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. PASI75 response was defined as at least a 75 percent (%) reduction in PASI relative to Baseline.|Week 12, 24|All treated participants with available post-baseline documentation.||percentage of participants|||Number
645097|NCT02192164|Secondary|Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at Week 12|PASI score is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck [h], arms [u], trunk [t], legs [l]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated: 0 (no involvement) to 6 (90–100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4.|Baseline, Week 12|All treated participants with available post-baseline documentation.||units on a scale||Standard Deviation|Mean
645098|NCT02192164|Primary|Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at Week 24|PASI score is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck [h], arms [u], trunk [t], legs [l]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated: 0 (no involvement) to 6 (90–100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4.|Baseline (Day 1), Week 24|All treated participants with available post-baseline documentation.||units on a scale||Standard Deviation|Mean
645099|NCT02191865|Secondary|Number (%) of Subjects With Drug-related Adverse Events (AEs)|Number (%) of subjects with drug-related Adverse events (AEs)|(AEs) during the 'on-treatment' period (from administration of trial medication until the end of the 28-day residual effect period); Up to 29 days|TS||percentage of participants|||Number
645167|NCT02189252|Secondary|Baseline-adjusted Cmax for Plasma Total DHA||This is a crossover study with two treatment periods. The estimated treatment effects were based on the within-subject comparison between the two treatments, each having a 4-week duration and a 4-week wash off period in between.|PK Population||ug/mL||Geometric Coefficient of Variation|Geometric Mean
645100|NCT02191865|Secondary|AUC (0-tz) of Nintedanib|AUC (0-tz) (Area under the concentration-time curve of the Nintedanib in plasma over the time interval from 0 to the last quantifiable drug plasma concentration)|Pre-dose and 1 hour (h), 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h and 168h after drug administration|Pharmacokinetic set (PKS): The PKS included all subjects of the TS who provided at least 1 observation for at least 1 primary PK endpoint, which was judged as PK evaluable and was not affected by important protocol violation(s) relevant to the evaluation of PK.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
645101|NCT02191865|Primary|Cmax of Nintedanib|Cmax (Maximum measured concentration of the Nintedanib in plasma)|Pre-dose and 1 hour (h), 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h and 168h after drug administration|Pharmacokinetic set (PKS): The PKS included all subjects of the TS who provided at least 1 observation for at least 1 primary PK endpoint, which was judged as PK evaluable and was not affected by important protocol violation(s) relevant to the evaluation of PK.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
645102|NCT02191865|Primary|AUC (0-inf) of Nintedanib|AUC (0-inf) (Area under the concentration-time curve of the Nintedanib in plasma over the time interval from 0 extrapolated to infinity)|Pre-dose and 1 hour (h), 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h and 168h after drug administration|Pharmacokinetic set (PKS): The PKS included all subjects of the TS who provided at least 1 observation for at least 1 primary PK endpoint, which was judged as PK evaluable and was not affected by important protocol violation(s) relevant to the evaluation of PK.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
645103|NCT02191046|Secondary|the Contamination in Nasal Irrigation Devices|compare the result of bacterial culture in both group of nasal irrigation devices. We reported in the following item; no growth, gram positive or gram negative or mixed organism|at second week after treatment||||||
645104|NCT02191046|Primary|the Effect of Squeezable Bottle and Syringe on Clinical Effectiveness in Sinusitis Children|For 5S-score, we measured the the mean 5-s score of both group at 2 weeks compare to the mean 5-s score at baseline visit and compare 5S-score between group at 2 weeks. The S5- score is a scale assessing severity of sinusitis. It compose of the symptom scores for nasal obstruction, day and nighttime cough, headache and nasal discharge. All symptom were graded from 0(no symptom) to 3 (severe ).The score were summed to give the mean 5S-score.It range from 0 (best possible outcome) to 15(worst possible outcome). 7-point Likert scale for satisfaction score is scale from 1 (indicating unsatisfactory) to 7 (indicating excellent). For satisfaction, we reported the result in the term of 7 points Likert scale and compare these scale between group at 2 weeks after treatment|compare 5S-score of both group at 2 week and at baseline visit .compare the mean 5S-score and satisfaction score between both group at 2 weeks after treatment|The S5- score is the symptom scores for nasal obstruction, day and nighttime cough, headache and nasal discharge. All symptom were graded from 0(no symptom) to 3 (severe ).The score were summed to give the mean 5S-score.7-point Likert scale for satisfaction score is scale from 1 (indicating unsatisfactory) to 7 (indicating excellent).||units on a scale||Standard Deviation|Mean
645105|NCT02191033|Secondary|Smoking Abstinence|biochemically confirmed point prevalence of self reported past 7-day abstinence|6- and 12- weeks|||Participants|||Count of Participants
645106|NCT02191033|Primary|Study Retention- Number of Participants Who Attend the 6- and 12-week Follow up Visits.|We will determine the number of enrolled participants who follow up at the 6- and 12- week follow up visit.|6- and 12- weeks|||Participants|||Count of Participants
645107|NCT02191033|Primary|Study Enrollment- Number of Participants Who Join the Study|We will report the number of persons who join the study.|baseline|||Participants|||Count of Participants
645108|NCT02190604|Secondary|Part 2: CLr in Healthy Volunteers|Pharmacokinetics of QBW251 in urine: renal clearance following drug administration. In this analysis CLr will be reported using urine samples taken on Day 1 from healthy volunteers.|Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose Day 1; Day 14 was calculated as urine was only collected up to 12 hours on Day 1 thus CLr cannot be calculated.|Pharmacokinetics analysis: All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis||L/hr||Standard Deviation|Mean
645109|NCT02190604|Secondary|Part 2: Ae0-t in Healthy Volunteers|Pharmacokinetics of QBW251 in urine: amount of drug excreted in urine from time zero until last measurable concentration. In this analysis Ae0-t will be reported using urine samples taken on Day 1 from healthy volunteers.|Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose Day 1|All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis||L/hr||Standard Deviation|Mean
645110|NCT02190604|Secondary|Part 3: Time to Maximum Concentration (Tmax)|Pharmacokinetics of QBW251 in plasma after multiple doses: time to reach the maximum concentration after administration of QBW251. In this analysis Tmax will be reported using blood samples taken on Days 1 and 14 in patients|Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4, 8 hr post-dose in Day 1, Day 14|Pharmacokinetics analysis: All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis||hr||Standard Deviation|Mean
645111|NCT02190604|Secondary|Part 3: Tlast in CF Patients|Blood samples were collected at timepoints prespecified in the study protocol. Tlast of QBW251 was the last time point when blood sample collected was quantifiable day 1 and day 14|Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4, 8 hr post-dose in Day 1, Day 14|Pharmacokinetics analysis: All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis||hr||Standard Deviation|Mean
645112|NCT02190604|Secondary|Part 3: Maximum Concentration (Cmax) in CF Patients|Observed maximum plasma concentration following administration of QBW251. In this analysis Cmax will be reported using blood samples taken on Day 1and day 14 from patients|Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4, 8 hr post-dose in Day 1, Day 14|Pharmacokinetics analysis: All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis||ng/mL||Standard Deviation|Mean
645113|NCT02190604|Secondary|Part 3: Plasma Concentration at the Last Quantifiable Time Point (Clast) of QBW251 in CF Patients|Blood samples were collected at timepoints prespecified in the study protocol. Tlast of QBW251 was the last time point when blood sample collected was quantifiable|Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4, 8 hr post-dose in Day 1, Day2|Pharmacokinetics analysis: All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis||ng/mL||Standard Deviation|Mean
645114|NCT02190604|Secondary|Part 3: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of QBW251 in CF Patients|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4, 8 hr post-dose in Day 1, Day 14|Pharmacokinetics analysis: All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis||ng × hr /mL||Standard Deviation|Mean
645115|NCT02190604|Secondary|Part 2: T1/2 in Healthy Volunteers|terminal elimination half-life (T1/2). In this analysis T1/2 will be reported using blood samples taken on Day 14 from healthy volunteers.|Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose Day 14; ( If B ID dosing, 12 hours samples will be pre-dosed)|Pharmacokinetics analysis: All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis||hr||Standard Deviation|Mean
645116|NCT02190604|Secondary|Part 2: Racc in Healthy Volunteers|Accumulation ratio (Racc). In this analysis Racc will be reported using blood samples taken on Days 1 - 14 from healthy volunteers.|Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose Day 1 - 14; ( If B ID dosing, 12 hours samples will be pre-dosed)|Pharmacokinetics analysis: All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis||Ratio||Standard Deviation|Mean
645117|NCT02190604|Secondary|Part 2: Vz/F in Healthy Volunteers|Apparent volume of distribution during the terminal elimination phase following extravascular administration. In this analysis Vz/F will be reported using blood samples taken on Day 14 from healthy volunteers.|Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose Day 14; ( If B ID dosing, 12 hours samples will be pre-dosed)|Pharmacokinetics analysis: All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis||Liters||Standard Deviation|Mean
645118|NCT02190604|Secondary|Part 2: CL/F in Healthy Volunteers|apparent systemic clearance from plasma following extravascular administration. In this analysis CL/F will be reported using blood samples taken on Day 14 from healthy volunteers.|Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose Day 14; ( If B ID dosing, 12 hours samples will be pre-dosed)|Pharmacokinetics analysis: All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis||L/hr||Standard Deviation|Mean
645119|NCT02190604|Secondary|Part 2: Cav in Healthy Volunteers|The average drug concentration in plasma during multiple dosing. In this analysis Cav will be reported using blood samples taken on Days 1 and 14 are from healthy volunteers.|Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose Day 1 and 14; ( If B ID dosing, 12 hours samples will be pre-dosed)|Pharmacokinetics analysis: All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis||ug/L||Standard Deviation|Mean
645120|NCT02190604|Secondary|Part 2: AUC0-t|Pharmacokinetics of QBW251 in plasma: area under the plasma concentration versus time curve from time zero to time of last measurable concentration. In this analysis AUC0-t will be reported using blood samples taken on Day 14 are from healthy volunteers.|Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose Day 14; ( If B ID dosing, 12 hours samples will be pre-dosed)|||hr*ng/mL||Standard Deviation|Mean
645121|NCT02190604|Secondary|Part 2: Time to Maximum Concentration (Tmax) in Healthy Volunteers|Pharmacokinetics of QBW251 in plasma after multiple doses: time to reach the maximum concentration after administration of QBW251. In this analysis Tmax will be reported using blood samples taken on Days 1 and 14 from healthy volunteers.|Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose Day 1 and 14; ( If B ID dosing, 12 hours samples will be pre-dosed)|Pharmacokinetics analysis: All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis||hr||Standard Deviation|Mean
645122|NCT02190604|Secondary|Part 2: Maximum Concentration (Cmax) in Healthy Volunteers|Pharmacokinetics of QBW251 in plasma after multiple doses: observed maximum plasma concentration following QBW251 at steady state. In this analysis Cmax will be reported using blood samples taken on Days 1 and 14 from healthy volunteers.|Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose Day 1 and 14; ( If B ID dosing, 12 hours samples will be pre-dosed)|Pharmacokinetics analysis: All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis||ug/L||Standard Deviation|Mean
645123|NCT02190604|Secondary|Part 2: AUCtau in Healthy Volunteers|Pharmacokinetics of QBW251 in plasma after multiple doses: the area under the plasma concentration-time curve from time zero to end of the dosing interval tau. In this analysis AUCtau will be reported. Samples taken on Days 1 and 14 from healthy volunteers|Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose Day 1 and 14; ( If B ID dosing, 12 hours samples will be pre-dosed)|Pharmacokinetics analysis: All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis||hr*ng/mL||Standard Deviation|Mean
645124|NCT02190604|Secondary|Part 1: Vz/F in Healthy Volunteers|Pharmacokinetics of QBW251 in plasma: apparent volume of distribution during the terminal elimination phase following extravascular administration. In this analysis Vz/F will be reported using blood samples taken on Days 1 - 5 from healthy volunteers.|Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose (i.e. Days 1 - 5)|All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis||Liters||Standard Deviation|Mean
645125|NCT02190604|Secondary|Part 1: CL/F in Healthy Volunteers|Pharmacokinetics of QBW251 in plasma: apparent systemic clearance from plasma following extravascular administration. In this analysis CL/F will be reported using blood samples taken on Days 1 - 5 from healthy volunteers. In part one of the study a single dose was administered and samples were collected up to 5 days. As a result the CL/F goes from Day 1 to Day 5 (for some lower doses QBW251 concentrations were not measured up to Day 5 as the concentrations were low due to the low dose administered)|Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose (i.e. Days 1 - 5)|All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis||L/hr||Standard Deviation|Mean
645126|NCT02190604|Secondary|Part 1: AUCinf in Healthy Volunteers|Pharmacokinetics of QBW251 in plasma: area under the plasma concentration time curve from time zero to infinity. In this analysis AUCinf will be reported using blood samples taken on Days 1 - 5 from healthy volunteers. In part one of the study a single dose was administered and samples were collected up to 5 days. As a result the AUCinf goes from Day 1 to Day 5 (for some lower doses QBW251 concentrations were not measured up to Day 5 as the concentrations were low due to the low dose administered)|Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose (i.e. Days 1 - 5)|All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis||hr*ng/mL||Standard Deviation|Mean
645127|NCT02190604|Secondary|Part 1: T1/2 in Healthy Volunteers|Pharmacokinetics of QBW251 in plasma: terminal elimination half-life. In this analysis T1/2 will be reported using blood samples taken on Days 1 - 5 from healthy volunteers. In part one of the study a single dose was administered and samples were collected up to 5 days. As a result the T1/2 goes from Day 1 to Day 5 (for some lower doses QBW251 concentrations were not measured up to Day 5 as the concentrations were low due to the low dose administered).|Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose (i.e. Days 1 - 5)|All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis||hr||Standard Deviation|Mean
645128|NCT02190604|Secondary|Part 1: Time to Maximum Concentration (Tmax) in Healthy Volunteers|Pharmacokinetics of QBW251 in plasma: time to reach the maximum concentration after administration of QBW251. In this analysis Tmax will be reported using blood samples taken on Days 1 - 5 from healthy volunteers. In this part of the study a single dose was administered and samples were collected up to 5 days. As a result the Tmax is one value as the concentration-time curve goes to Day 5 (for some lower does QBW251 concentrations were not measured up to Day 5 as the concentrations were low due to the low dose administered).|Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose (i.e. Days 1 - 5)|All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis||hr||Standard Deviation|Mean
645129|NCT02190604|Secondary|Part 1: Maximum Concentration (Cmax) in Healthy Volunteers|Pharmacokinetics of QBW251 in plasma: observed maximum plasma concentration following administration of QBW251. In this analysis Cmax will be reported using blood samples taken on Days 1- 5 are from healthy volunteers|Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose (i.e. Days 1 - 5)|All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis||ug/L||Standard Deviation|Mean
645130|NCT02190604|Secondary|Part 1: AUC0-t in Healthy Volunteers|Pharmacokinetics of QBW251 in plasma: area under the plasma concentration versus time curve from time zero to time of last measurable concentration (AUC0-t). In part one of the study a single dose was administered and samples were collected up to 5 days. As a result the AUC0-t goes from Day 1 to Day 5 (for some lower doses QBW251 concentrations were not measured up to Day 5 as the concentrations were low due to the low dose administered)|Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose (i.e. Days 2-5)|All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis.||hr*ng/mL||Standard Deviation|Mean
645131|NCT02190604|Secondary|Part 3: Change in Cystic Fibrosis Questionnaire-Revised Reported Outcomes|Change in Cystic Fibrosis Questionnaire data will be obtained from patient reported outcomes (CFQ-R PRO). Respiratory Domain, cores range from 0 to 100, with higher scores indicating better health, a change of 4 is considered clinically relevant|Baseline and Day 14|Pharmacodynamics (PD) analysis set: All randomized patients were included in the PD analysis||Units on a scale||Standard Error|Least Squares Mean
645132|NCT02190604|Secondary|Part 3:Change in Forced Expiratory Volume in 1 Second (FEV1) at Day 15|Forced Expiratory Volume in 1 second (FEV1) will be measured via spirometer according to international standards. Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation|Baseline and Day 15|Pharmacodynamics (PD) analysis set: All randomized patients were included in the PD analysis||Liters||Standard Error|Least Squares Mean
645133|NCT02190604|Primary|Part 3: Number of Participants (Patients) With Reported Adverse Events Receiving QBW251|All adverse events and serious adverse events (in patients) reported.|Day 1 to Day 56|Safety analysis set: All randomized patients were included in the safety analysis||Participants|||Number
647354|NCT02127567|Secondary|The Score for Completeness of Reporting for Blinding|on a scale from 0 to 10, 0 being the lowest and 10 the highest|one time measure after a four-hour writing session|||units on a scale|Participants|Standard Deviation|Mean
645134|NCT02190604|Primary|Part 3: Change in Lung Clearance Index (LCI) From Baseline to Day 15|Change in Lung Clearance Index (LCI) will be conducted according to international standards in cystic fibrosis patients. Lung clearance index (LCI) is a measure of ventilation inhomogeneity that is derived from a multiple-breath washout test, A reduction in mean change from baseline for LCI2.5 indicates improvement.|Baseline and Day 15|Pharmacodynamics (PD) analysis set: All randomized patients were included in the PD analysis||Ratio||Standard Deviation|Mean
645135|NCT02190604|Primary|Part 1 and 2:Number of Participants (Healthy Volunteers) With Reported Adverse Events Receiving QBW251|All adverse events (in healthy volunteers) reported.|Day 1 to Day 36|All treated subjects were included in the data analysis. Subjects were analyzed according to the study treatment(s) received.||Participants|||Number
645136|NCT02190591|Other Pre-specified|Third and Fourth Degree Lacerations|Measuring if use of the Peanut Labor Ball impacts third and fourth degree lacerations during delivery|within the last 15-30 minutes of birth|participants with vaginal delivery only||Participants|||Count of Participants
645137|NCT02190591|Secondary|Dilation to Second Stage Labor|Examining if use of the peanut labor ball has an effect on time between administration of epidural to complete dilation|thirty minutes after epidural given to birth of baby|Included participants with vaginal delivery only||minutes||Standard Deviation|Mean
645138|NCT02190591|Primary|Delivery Rate|Rate of patients who deliver by cesarean section|.5-72 hours|||participants|||Number
645139|NCT02190435|Secondary|Radiation Exposure|Intraoperative fluoroscopy exposure time for lag screw placement (seconds)|Intraoperative|||seconds||Standard Deviation|Mean
645140|NCT02190435|Primary|Tip-to-apex Distance|Distance between lag screw tip and head surface as measured on the ADAPT system|Intraoperative|||mm||Standard Deviation|Mean
645141|NCT02189954|Secondary|Postoperative Pharyngolaryngeal Morbidity at Postoperative 24.Hour|The primer outcome was a composite endpoint of any pharyngolaryngeal complications such as sore throat, dysphonia and dysphagia according to Likert scale ranges from 1 (none) to 4 (severe) at postoperative 24.hour|Postoperative 24.hour|Chi Square Test for categorical variables, for constant variables t test when suitable for normal distribution and when unsuitable for normal distrubition Mann Whitney U have been used for analysis. p < 0.05 was considered significant.||units on a scale||Full Range|Median
645142|NCT02189954|Primary|Postoperative Pharyngolaryngeal Morbidity Postoperative 1.Hour|The primary outcome was a composite endpoint of any pharyngolaryngeal complications such as sore throat, dysphonia and dysphagia according to Likert scale ranges from 1 (none) to 4 (severe) at postoperative 1.hour|Postoperative 1.hour|||units on a scale||Full Range|Median
645143|NCT02189941|Secondary|Safety and Tolerability of Deferiprone Sustained Release Tablets|The number of participants who experienced adverse events between the time of dosing up to 24 hours post-dose, including any changes of clinical significance in vital signs, 12-lead ECG, and clinical laboratory tests|From time of dose until 24 hours post dose|All subjects who received at least one dose of study medication and had at least one safety assessment||participants|||Number
645144|NCT02189941|Primary|Thalf for Serum Deferiprone and Deferiprone 3-O-glucuronide|Thalf (the apparent terminal elimination half-life of the drug) was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained prior to dosing and at 0.25, 0.5, 0.75, 1, 1.3333, 1.6667, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16 and 24 hours post-dose.|24-hour interval|All subjects who contributed evaluable pharmacokinetics data||h||Standard Deviation|Mean
645145|NCT02189941|Primary|Tmax for Serum Deferiprone and Deferiprone 3-O-glucuronide|Tmax (the time to Cmax) was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained prior to dosing and at 0.25, 0.5, 0.75, 1, 1.3333, 1.6667, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16 and 24 hours post-dose.|24-hour interval|All subjects who contributed evaluable pharmacokinetics data||h||Standard Deviation|Mean
645146|NCT02189941|Primary|Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide|Cmax (maximum concentration in the serum) was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained prior to dosing and at 0.25, 0.5, 0.75, 1, 1.3333, 1.6667, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16 and 24 hours post-dose.|24-hour interval|All subjects who contributed evaluable pharmacokinetics data||mcg/mL||Standard Deviation|Mean
645147|NCT02189941|Primary|AUCinf for Serum Deferiprone and Deferiprone 3-O-glucuronide|AUCinf (Area Under the Curve to infinity) was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained prior to dosing and at 0.25, 0.5, 0.75, 1, 1.3333, 1.6667, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16 and 24 hours post-dose.|24-hour interval|All subjects who contributed evaluable pharmacokinetics data||mcg*h/mL||Standard Deviation|Mean
645148|NCT02189941|Primary|AUCt for Serum Deferiprone and Deferiprone 3-O-glucuronide|AUCt (Area Under the Curve to the last measured time) was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained prior to dosing and at 0.25, 0.5, 0.75, 1, 1.3333, 1.6667, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16 and 24 hours post-dose.|24-hour interval|All subjects who contributed evaluable pharmacokinetics data||mcg*h/mL||Standard Deviation|Mean
645149|NCT02189915|Secondary|Phosphocreatine Levels Measured by Magnetic Resonance Spectroscopy|Phosphocreatine (PCr) was measured pre- and post-creatine treatment to assess changes in neurochemistry. Creatine treatment may increase brain intracellular PCr, and brain energy metabolism has been suggested to play a role in the pathophysiology of depression. Increased levels of PCr suggest reduced depressive symptoms. PCr levels are calculated using a ratio and remains unitless.|8 weeks|||Phosphocreatine levels (unitless)||Standard Deviation|Mean
645150|NCT02189915|Primary|Depression Rating Scores|Hamilton Depression Rating Scale scores is used to assess the level of depression. The Hamilton Depression Rating Scale ranges from 0 to 50. A score of 0-7 is considered to be normal. A score of 8-13 indicates mild depression. A score of 14-18 indicates moderate depression. Scores higher than 19 indicate severe depression.|8-week|||units on a scale||Standard Deviation|Mean
645151|NCT02189863|Secondary|Standard Deviation of Lateral Positioning|The standard deviation of lateral positioning (staying in the lane) was assessed during simulated night time driving and measured as the distance of deviation from the reference point, in meters. This outcome measure is prespecified for AOAMV and AOAMF.|Week 2, each period|This analysis population includes all randomized subjects in the groups to which they were randomly assigned who successfully completed both study lens follow-up evaluations without a protocol deviation that was documented as impacting the assessment of the hypotheses (Per-Protocol).||meters||Standard Deviation|Mean
645152|NCT02189863|Primary|Driving Reaction Time to Hazards (as Measured by Time to Brake, in Seconds)|Driving reaction time to hazards was assessed during simulated night time driving and measured as time to brake, in seconds. One eye (study eye) contributed to the analysis. This outcome measure was prespecified for AOAMV and AOAMF.|Week 2, each period|This analysis population includes all randomized subjects in the groups to which they were randomly assigned who successfully completed both study lens follow-up evaluations without a protocol deviation that was documented as impacting the assessment of the hypotheses (Per-Protocol).||seconds||Standard Deviation|Mean
645158|NCT02189759|Secondary|Duration of Kangaroo Mother Care|Skin to skin contact between baby and mother|Duration of hospitalization-an average of 2 weeks|"Infants in Standard Kanagroo Mother Care to one hour after birth and Standard Kangaroo Mother care to discharge groups received kangaroo mother care only during breastfeeding"||Hours||Standard Error|Mean
645159|NCT02189759|Secondary|Number Infants Admitted to the Neonatal Intensive Care Unit|Any admission to the neonatal intensive care unit for higher level care|Duration of hospitalization-an average of 2 weeks|||Participants|||Count of Participants
645160|NCT02189759|Primary|Number of Infants With Axillary Temperature < 36.0 Degrees Celsius at Discharge|Temperature taken per axilla using diigital thermometer at Discharge or 24hrs after birth|At discharge or 24 hours after birth (whichever is first)|||Participants|||Count of Participants
645161|NCT02189759|Primary|Number of Infants With Axillary Temperature <36.0 Degrees Celsius|Temperature taken per axilla using digital thermometer|Time of birth to 1 hour|||Participants|||Count of Participants
645162|NCT02189317|Secondary|Difference in Time to First Opioid Use|The time difference in hours to first Percocet (7.5/325 tablets) usage post-surgery.|Day of Surgery, Post-Operative Day 6 (Up to 144 hours)|"Participants who underwent ACL reconstruction surgery and returned a completed post-operative pain and medication journal (bupivacaine HCl group).
Participants who underwent ACL reconstruction surgery, returned a completed post-operative pain and medication journal, and did not require reoperation (Exparel liposomal/bupivacaine group)."||hours||Standard Deviation|Mean
645163|NCT02189317|Secondary|Change in Home Opioid Use|The difference in amount of Percocet (7.5/325 tablets) usage post-surgery.|Day of Surgery, Post-Operative Day 6 (Up to 144 hours)|"Participants who underwent ACL reconstruction surgery and returned a completed post-operative pain and medication journal (bupivacaine HCl group).
Participants who underwent ACL reconstruction surgery, returned a completed post-operative pain and medication journal, and did not require reoperation (Exparel liposomal/bupivacaine group)."||miligrams||Standard Deviation|Mean
645164|NCT02189317|Primary|Change in Numerical Rating Scale (NRS) Pain Score|The numerical rating scale (NRS) pain score is a self-reported pain scale from 0 to 10 where zero is equal to “no pain” and ten is equal to “worst possible” pain. The score was recorded every 12 hours for up to 144 hours (six days) post-operatively.|Day of Surgery, Post-Operative Day 6 (Up to 144 hours)|"Participants who underwent ACL reconstruction surgery and returned a completed post-operative pain and medication journal (bupivacaine HCl group).
Participants who underwent ACL reconstruction surgery, returned a completed post-operative pain and medication journal, and did not require reoperation (Exparel liposomal/bupivacaine group)."||units on a scale||Standard Deviation|Mean
645165|NCT02189252|Secondary|Baseline-adjusted Cmax for Plasma Total DPA||participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.|PK Population||ug/mL||Geometric Coefficient of Variation|Geometric Mean
645168|NCT02189252|Secondary|Baseline-adjusted AUC0-24 for Plasma Total DHA||participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.|PK Population||hr*ug/mL||Geometric Coefficient of Variation|Geometric Mean
645169|NCT02189252|Secondary|Baseline-adjusted Cmax for Plasma Total EPA||participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.|PK Population||ug/mL||Geometric Coefficient of Variation|Geometric Mean
645170|NCT02189252|Secondary|Baseline-adjusted AUC0-24 for Plasma Total EPA||participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.|PK Population||hr*ug/mL||Geometric Coefficient of Variation|Geometric Mean
645171|NCT02189252|Primary|Baseline-adjusted Cmax for Plasma Total EPA + Total DHA|Cmax: Maximum measured plasma concentration over the time span specified|participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.|PK population||nmol/mL||Geometric Coefficient of Variation|Geometric Mean
645172|NCT02189252|Primary|Baseline-adjusted AUC0-24 for Plasma Total EPA + Total DHA|AUC0-24: Area under the plasma concentration versus time curve, from time 0 to 24 hours after start of the meal|participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.|PK population||hr*nmol/mL||Geometric Coefficient of Variation|Geometric Mean
645173|NCT02189161|Secondary|Quality of Life Assessment: Subject Score for Worry About Anal Canal Condition|Median from subject scores for worry about anal canal condition at 0-2 weeks prior to RFA treatment and after 9-12 months post RFA. Median scale range: 0-10 (minimum concern=0, maximum concern=10)|0-2 weeks Prior RFA and after 9-12 months post RFA|||units on a scale||Full Range|Median
645174|NCT02189161|Secondary|Subject Tolerability: Post -Ablation Anal Pain|Median post-ablation anal pain from 10 patients' survey after RFA treatment. Anal pain scale range: 0-10 (minimum pain=0, maximum pain=10)|within 4 weeks post RFA|||units on a scale||Full Range|Median
645175|NCT02189161|Primary|Related Adverse Events|Adverse event : Device relationship - Definite, Probable, Possible|Within 12 months post RFA|||number of participants|||Number
645176|NCT02189122|Primary|Urine Prostacyclin Concentrations at 162.5 mg ASA or NHP-544C Dose||24 hour collection|Data are given for 162.5 mg study day||ng/mg creatinine||Inter-Quartile Range|Median
645177|NCT02189122|Primary|Urine Prostacyclin Concentrations at 81 mg ASA or NHP-544C Dose||24 hour collection|||ng/mg creatinine||Inter-Quartile Range|Median
645178|NCT02189122|Primary|Urine Prostacyclin Concentrations at Placebo ASA or Placebo NHP-544C Dose||24 hour collection|||ng/mg creatinine||Inter-Quartile Range|Median
645179|NCT02189122|Primary|Urine Thromboxane Concentrations at 162.5 mg ASA or NHP-544C Dose||24 hour collection|||ng/mg creatinine||Inter-Quartile Range|Median
645180|NCT02189122|Primary|Urine Thromboxane Concentrations at 81mg ASA or NHP-544C Dose||24 hour collection|||ng/mg creatinine||Inter-Quartile Range|Median
645181|NCT02189122|Primary|Urine Thromboxane Concentrations at Placebo ASA or Placebo NHP-544C Dose||24 hour collection|||ng/mg creatinine||Inter-Quartile Range|Median
645182|NCT02188849|Other Pre-specified|Serum Creatinine|Serum creatinine levels|Twelve weeks|||mg/dl||Standard Deviation|Mean
645183|NCT02188849|Secondary|Twelve Minutes Walk|Measurement of the distance that a participant can walk during 12 minutes|Twelve weeks|||meters||Standard Deviation|Mean
645184|NCT02188849|Secondary|Quadriceps Isometric Strength|Measurement of quadriceps isometric force using a quadriceps table|Twelve weeks|||Newtons||Standard Deviation|Mean
645185|NCT02188849|Primary|Rectus Femoris Cross Sectional Height|Measurement of rectus femoris cross sectional height in the mid thigh by ultrasound|Twelve weeks|||cm||Standard Deviation|Mean
645186|NCT02188784|Secondary|Change From Baseline in Ventilatory Efficiency Defined by Ve/VCO2|Change from baseline in Ventilatory Efficiency defined by Ve/VCO2 (carbon dioxide output) as measured by CPET|Measured at BL week 16|All randomized patients with available change data||VE/VCO2 Slope||Standard Deviation|Mean
645187|NCT02188784|Secondary|Change From Baseline in O2 Uptake Kinetics as Assessed by Mean Response Time From CPET|To determine the impact of oral Fe repletion on O2 Uptake Kinetics as measured by CPET|Measured at BL week 16|All randomized patients with available change data||seconds||Standard Deviation|Mean
645188|NCT02188784|Secondary|Change in Health Status: Kansas City Cardiomyopathy Questionnaire (KCCQ) - Clinical Summary Score|"To determine the impact of oral Fe repletion on Health Status: KCCQ.
KCCQ is a 23-item, self administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life for patients with congestive heart failure. It is a predictive tool that tracks how patients are doing if they have weakened heart muscle due to prior heart attacks, heart valve problems, viral infections, or other causes.
The KCCQs questions are used to calculate scores in ten domains. Physical Limitation, Symptom Stability, Frequency, Burden and Total Symptom. Social Limitation, Self-Efficacy, Quality of Life, and Clinical Summary. Overall summary: a combined measure of all the above.
For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Scores are transformed to a range of 0-100, in which higher scores reflect better health status."|Measured at Baseline, Week 8 and Week 16|All randomized patients with available change data||units on a scale||Standard Deviation|Mean
645189|NCT02188784|Secondary|Change in Plasma NT-pro BNP|To determine the impact of oral Fe repletion on Plasma N-terminal pro-B-type natriuretic peptide (NT-pro BNP)|Measured at Baseline and Week 16|All randomized patients with available change data||pg/ml||Standard Deviation|Mean
645190|NCT02188784|Secondary|Change From Baseline in Sub-maximal Exercise Capacity as Assessed by the 6 Minute Walk Test (6MWT)|To determine the impact of oral Fe repletion on Submaximal exercise capacity as measured by 6MWT|Measured at BL, week 8 and week 16|All randomized patients with available change data||meters||Standard Deviation|Mean
645191|NCT02188784|Primary|Change in Peak VO2 (ml/Min) (VO2 =Oxygen Consumption)|To determine if oral Fe (Iron) polysaccharide is superior to oral placebo in improving functional capacity as measured by change in peak VO2 by CPET (Cardiopulmonary Exercise Testing) , of a broad population of patients with HFrEF (Heart Failure with Reduced Ejection Fraction) and Fe deficiency at 16 weeks.|Baseline (BL) and Week 16|All randomized patients with available change data||mL/min||Standard Deviation|Mean
645192|NCT02188589|Secondary|Secondary Efficacy Endpoint|"Nasal patency assessed by validated NOSE (Nasal Obstruction Symptom Evaluation) Questionnaire. The NOSE score uses a 0 - 20 point scale to capture severity of breathing symptoms, with higher scores indicating more severe symptoms than lower scores. NOSE scores are converted to a 100-point scale by multiplying the total score by 5."|6 months|||scores on a scale||Standard Deviation|Mean
645193|NCT02188589|Primary|Implant Related Adverse Events|Implant related adverse events|6 months|||implant related adverse events|Number of Implants||Number
645194|NCT02187809|Secondary|Percentage of Initial Treatment Responders Who Returned to Their Baseline Tonic-clonic and Clonic Seizure Rate During the Study (an Assessment of Tachyphylaxis)||Baseline and from Day 0 to Day 360|At the time of study termination, only one patient had received IMP. No seizure data were summarised for that single patient.|||||
645195|NCT02187809|Secondary|Number of Initial Treatment Responders Who Returned to Their Baseline Tonic-clonic and Clonic Seizure Rate During the Study (an Assessment of Tachyphylaxis)||Baseline and from Day 0 to Day 360|At the time of study termination, only one patient had received IMP. No seizure data were summarised for that single patient.|||||
645196|NCT02187809|Secondary|Change in Mean Weekly Number of Tonic-clonic and Clonic Seizures||Baseline and from Day 0 to Day 360 and upon Study Completion/Withdrawal|At the time of study termination, only one patient had received IMP. No seizure data were summarised for that single patient.|||||
645197|NCT02187809|Primary|Change in Behavioural, Neurocognitive Measures Using Vineland Adaptive Behaviour Scale (VABS)||Baseline and from Day 0 to Day 360|At the time of study termination, only one patient had received IMP. No VABS data were recorded for that single patient.|||||
645198|NCT02187809|Primary|Columbia Suicide Severity Rating Scale (C-SSRS), Categorisation Based on Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories (1, 2, 3, 4 and 7) for Patients Aged ≥ 6 Years||Baseline and from Day 0 to Day 360|At the time of study termination, one patient had received IMP. No C-SSRS data were collected from that single patient.|||||
645199|NCT02187809|Primary|Number of Participants With Adverse Events of Special Interest as a Measure of Safety and Tolerability Based on Dose||Up to Day 390|At the time of study termination, only one patient had received IMP. No adverse events were observed in the study||participants|||Number
645200|NCT02187809|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability||Up to Day 390|At the time of study termination, only one patient had received IMP. No adverse events were observed in the study.||participants|||Number
645201|NCT02187744|Secondary|Incidence of Neutralizing Antibodies (NAb) at Cycles 1 Through 6.|The number of participants with positive (NAb response >=1.48) pre-dose NAb samples, participants counted towards the total if for at least one sample, the NAb was positive.|Cycles 1 through 6|All participants who received at least 1 dose of study drug.||Number of participants|||Number
645202|NCT02187744|Secondary|Incidence of Anti-trastuzumab Antibodies (ADAs) at Cycles 1 Through 6.|The number of participants with positive (titer >=1.00) pre-dose ADA samples, participants counted towards the total if for at least one sample, the ADA was positive.|Cycles 1 through 6|All participants who received at least 1 dose of study drug.||Number of participants|||Number
645203|NCT02187744|Secondary|Objective Response Rate (ORR) Defined as the Percentage of Participants Having Complete or Partial Response at End of Treatment, Based on Radiographic Assessments of the Tumor.|ORR was defined as Complete Response (CR), Partial Response (PR), Stable (SD), Progressive Disease (PD) or Indeterminate (IND). ORR was the percentage of participants who had CR or PR at Cycle 6/End of treatment.|Cycle 6/End of treatment|All participants who were HER2+ and randomized into the study; and who have received 6 cycles of PF-05280014 or trastuzumab-EU treatment; and had no temporary delays of PF-05280014 or trastuzumab-EU treatment lasting more than 1 week; and had no other significant protocol deviations.||Percentage of participants||95% Confidence Interval|Number
645204|NCT02187744|Secondary|Pathologic Complete Response (pCR) Defined as the Absence of Invasive Neoplastic Cells in the Breast and Lymph Nodes.|Following surgery after treatment completion, tumors were assessed as Complete Pathological Response, Partial Pathological Response, or No Pathological Response.|Cycle 6/End of treatment|All participants who were HER2+ and randomized into the study; and who have received 6 cycles of PF-05280014 or trastuzumab-EU treatment; and had no temporary delays of PF-05280014 or trastuzumab-EU treatment lasting more than 1 week; and had no other significant protocol deviations.||Percentage of participants||95% Confidence Interval|Number
645205|NCT02187744|Secondary|Mean Predose Trastuzumab-Pfizer and Trastuzumab-EU Concentrations at Cycles 1 Through 6.|Samples of blood were taken pre-dose on Cycles 1, 2, 4, 5, and 6, and at 1 hour post dose on Cycles 1 and 5 for pharmacokinetic evaluation.|Cycles 1 through 6|All participants who were HER2+ and randomized into the study; and who have received 6 cycles of PF-05280014 or trastuzumab-EU treatment; and had no temporary delays of PF-05280014 or trastuzumab-EU treatment lasting more than 1 week; and had no other significant protocol deviations.||μg/mL||Standard Deviation|Mean
645206|NCT02187744|Primary|Percentage of Participants With Steady State Drug Concentration Ctrough (Cycle 6 Pre-dose) >20 µg/mL at Cycle 5.|The percentage of participants with Cycle 5 Ctrough (Cycle 6 pre-dose) >20 μg/mL in each treatment group, the denominator being the number of participants in the per protocol population for each treatment group.|Cycle 5|All participants who were HER2+ and randomized into the study; and who had received 6 cycles of PF-05280014 or trastuzumab-EU treatment; and had no temporary delays of PF-05280014 or trastuzumab-EU treatment lasting more than 1 week; and had no other significant protocol deviations.||Percentage of participants||95% Confidence Interval|Number
645207|NCT02187029|Secondary|Change From Baseline in Urinary Hypoxanthine Levels at Day 1, Day 7, and Day 14|Change from baseline in urinary hypoxanthine cumulative amounts at Day 1, Day 7 and Day 14|Baseline, Day 1, Day 7 and Day 14|The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment; n=number of participants analyzed in each respective arm.||mg||Standard Deviation|Mean
645208|NCT02187029|Secondary|Change From Baseline in Urinary Xanthine Levels at Day 1, Day 7, and Day 14|Change from baseline in urinary xanthine cumulative amounts.|Baseline, Day 1, Day 7 and Day 14|The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment; n=number of participants analyzed in each respective arm.||mg||Standard Deviation|Mean
645392|NCT02179398|Primary|Antibiotic Prescription Rate||at PED (Pediatric Emergency Department) presentation|children 7 days – 36 months old presenting to the PED with fever without source (FWS) ≥38.0°C (≥ 100.4°F) after a thorough history and careful examination||participants|||Number
645209|NCT02187029|Secondary|Change From Baseline in Urinary Uric Acid Levels at Day 1, Day 7, and Day 14|Change from baseline in urinary uric acid cumulative amounts.|Baseline, Day 1, Day 7 and Day 14|The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment; n=number of participants analyzed in each respective arm.||mg||Standard Deviation|Mean
645210|NCT02187029|Secondary|Change From Baseline in Plasma Levels of Hypoxanthine at Day 1, Day 7, Day 14, and at Follow-up||Day 1, Day 7, Day 14, and at follow-up visit (Day 25-29)|The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment; n=number of participants analyzed in each respective arm.||mcg/mL||Standard Deviation|Mean
645211|NCT02187029|Secondary|Change From Baseline in Plasma Levels of Xanthine at Day 1, Day 7, Day 14, and at Follow-up|Change in plasma levels of xanthine from baseline at time points 0 (prior to dosing except on Day 1), 1, 2, 4, 8, 12 and 24 hours following dosing with PF-06743649 or placebo on days 1, 7 and 14 as well prior to dosing on days 3 and 11 and at follow-up of treatment with PF-06743649 or placebo.|Baseline, Day 1, Day 7, Day 14, and at follow-up visit (Day 25-29)|The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment; n=number of participants analyzed in each respective arm.||micrograms per milliliter (mcg/mL)||Standard Deviation|Mean
645212|NCT02187029|Secondary|Plasma Levels of PF-06743648 After Initiation of Dosing at Day 1, Day 7, and Day 14|PF-06743648 is an active metabolite of PF-06743649. Data has been calculated by setting concentration values below the lower limit of quantification to zero. The lower limit of quantification was 2.00 nanograms per milliliter (ng/mL).|Day 1, Day 7, and Day 14|The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment; n=number of participants analyzed in each respective arm.||ng/mL||Standard Deviation|Mean
645213|NCT02187029|Secondary|Plasma Levels of PF-06743649 After Initiation of Dosing at Day 1, Day 7, and Day 14|Data has been calculated by setting concentration values below the lower limit of quantification to zero. The lower limit of quantification was 10.0 nanograms per milliliter (ng/mL).|0, 1, 2, 4, 8, 12 and 24 hours at Day 1, Day 7, and Day 14|All participants randomized and treated who have at least 1 measureable concentration; n=number of participants analyzed in each respective arm.||ng/mL||Standard Deviation|Mean
645214|NCT02187029|Secondary|Duration of Gout Flare Attacks|Duration of gout flare attacks with participants who developed gout flare attacks.|Baseline up to Day 42|Participants who developed gout flare attacks (Duration was not assessed as no participant developed gout flare attacks).|||||
645215|NCT02187029|Secondary|Incidence and Severity of Gout Flare Attacks||Baseline up to Day 42|The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment.||participants|||Number
645216|NCT02187029|Secondary|Number of Participants Reaching Serum Uric Acid Levels <6, <5 and <4 mg/dL at 24 Hours Post Dose on Day 7 and Day 14|Number of participants reaching serum uric acid levels <6, <5 and <4 mg/dL at 7 and 14 days after initiation.|24 hours post dose on Day 7 and Day 14|The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment.||participants|||Number
645217|NCT02187029|Secondary|Change From Baseline in Serum Uric Acid Levels at Day 1, Day 3, Day 7, Day 11, Day 14 and Follow-up||Day 1, Day 3, Day 7, Day 11, Day 14 and follow-up visit (Day 25-29)|The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment; n=number of participants analyzed in each respective arm.||mg/dL||Standard Deviation|Mean
645218|NCT02187029|Primary|Number of Participants With Electrocardiogram (ECG) Values Meeting Categorical Summarization Criteria|Criteria for potential clinically important changes in ECG (12-lead) were defined as: the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization (PR interval) >=300 milliseconds (msec) or increase from baseline >=25% when baseline >200 msec or increase from baseline >=50% when baseline less than or equal to (<=) 200 msec; time from the beginning of the electrocardiogram Q wave to the end of the S wave corresponding to ventricular depolarization (QRS) interval >=140 msec or >=50% increase from baseline; the beginning of the Q wave to the end of the T wave corresponding to electrical systole (QT) interval corrected using the Fridericia formula (QTcF) of 450 to < 480 msec, 480 to <500 msec and >=500 msec, or an increase of 30 to <60 msec or >=60 msec from baseline.|Baseline up to Day 16|The safety analysis population included all participants who received at least 1 dose of study medication.||participants|||Number
645219|NCT02187029|Primary|Number of Participants With Potentially Clinically Significant Vital Signs Findings|Criteria for potential clinically important change in vital signs included: Systolic blood pressure (BP) less than (<) 90 millimeters of mercury (mmHg) or more than or equal to (>=)30 mmHg change from baseline, diastolic BP of <50 mmHg or >=20 mmHg change from baseline, Supine pulse rate of <40 or more than (>)120 beats per minute (bpm).|Baseline up to follow up visit (Day 25-29)|The safety analysis population included all participants who received at least 1 dose of study medication.||participants|||Number
645220|NCT02187029|Primary|Number of Participants With Laboratory Test Abnormalities|Number of participants with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters include hematology (Hemoglobin, Hematocrit, red blood cell [RBC] count, Platelet count, mean corpuscular volume [MCV], mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration [MCHC], white blood cell [WBC] count, Total neutrophils, Eosinophils, Monocytes, Basophils, Lymphocytes), hematocrit (blood urea nitrogen [BUN]/urea and Creatinine, Glucose , Calcium, Sodium, Potassium, Chloride, Total CO2 [Bicarbonate], aspartate transaminase [AST], alanine transaminase [ALT], Total Bilirubin, Alkaline phosphatase, Albumin, Total protein, Thyroid Stimulating Hormone [TSH], free T3 [FT3] and free T4 [FT4] ), urinalysis (pH, Glucose [qual], Protein, Blood, Ketones, Nitrites, Leukocyte esterase, Urobilinogen, Urine bilirubin, Microscopy [including crystals]) and other (follicle-stimulating hormone [FSH], Urine drug screen).|Baseline up to follow up visit (Day 25-29)|The safety analysis population included all participants who received at least 1 dose of study medication.||participants|||Number
645297|NCT02182895|Secondary|Patient Satisfaction|Diabetes Treatment Satisfaction Questionnaire - InPatient (DTSQ-IP). This questionnaire had 14 items that were scored on a scale of 0 to 6. Total score for each subjects could range from 0-84. Higher score means better satisfaction.|At the time of discharge or Day 5|||Score||Standard Deviation|Mean
645298|NCT02182895|Secondary|Length of Hospital Stay|Number of days in hospital|Admission to discharge, an expected average of 5 days|completed||days||Standard Deviation|Mean
645221|NCT02187029|Primary|Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state AEs included both serious and non-serious events.|Baseline up to 28 days after last study drug administration (Day 42)|The safety analysis population included all participants who received at least 1 dose of study medication.||participants|||Number
645222|NCT02187029|Primary|Percent Change From Baseline in Serum Uric Acid Level at 24 Hours Post Dose on Day 14||Day 14 Hour 24|The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment. Number of participants analyzed is number of evaluable participants for this outcome measure. No data due to “Cohort 2: PF-06743649 5 mg” termination after 2 days of dosing.||percent (%)||Standard Deviation|Mean
645223|NCT02187029|Primary|Baseline of Serum Uric Acid|An elevation in serum uric acid, hyperuricemia, is a prerequisite for the development of gout.|Baseline (pre-dose Day 1)|The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment.||milligram per deciliter(mg/dL)||Standard Deviation|Mean
645224|NCT02187016|Secondary|Change From Baseline in Rustogi Modification of Navy Plaque Index (RMNPI) Using a Dichotomous Scale at Day 28|RMNPI is a validated assessment of visual surface dental plaque using a dichotomous scale 0 (absence) to 1 (presence).|28 days|||units on a scale||Standard Error|Least Squares Mean
645225|NCT02187016|Secondary|Change From Baseline Using Rustogi Modification of the Navy Plaque Index (RMNPI) Using a Dichotomous Scale at Day 14|RMNPI is a validated assessment of visual surface dental plaque using a dichotomous scale 0 (absence) to 1 (presence).|14 days|||units on a scale||Standard Error|Least Squares Mean
645226|NCT02187016|Secondary|Change From Baseline in Gingival Bleeding Index (GBI) on a 4 Point Scale at Day 28|GBI is a validated assessment of gingival bleeding using a 4 point scale with 0 (no bleeding) to 3 (spontaneous bleeding).|28 days|||units on a scale||Standard Error|Least Squares Mean
645227|NCT02187016|Secondary|Change From Baseline in Gingival Bleeding Index (GBI) on a 4 Point Scale at Day 14|GBI is a validated assessment of gingival bleeding using a 4 point scale with 0 (no bleeding) to 3 (spontaneous bleeding).|14 days|||units on a scale||Standard Error|Least Squares Mean
645228|NCT02187016|Secondary|Change From Baseline in Gingival Inflammation on a 4 Point Scale Using the Modified Gingival Index (MGI) at Day 28|MGI is a validated assessment of Gingival inflammation using a 4 point scale from 0 (absence of inflammation) to 4 (severe inflammation).|28 days|||units on a scale||Standard Error|Least Squares Mean
645229|NCT02187016|Primary|Change From Baseline in Gingival Inflammation on a 4 Point Scale Using the Modified Gingival Index (MGI) at Day 14|MGI is a validated assessment of Gingival inflammation using a 4 point range where 0 (absence of inflammation) to 4 (severe inflammation).|14 days|||units on a scale||Standard Error|Least Squares Mean
645230|NCT02186808|Secondary|Success Rate of Bridge Procera Bridge Zirconia|The CDA index (1) is Romeo or Sierra at delivery and remains so 5 year post loading.|prosthesis delivery, 5 years|5 year data. Not all initially treated patients could be followed over the 5 years.||percentage of successful implants|Participants||Number
645231|NCT02186808|Primary|Success Rate of Bridge Procera Bridge Zirconia|The CDA index (1) is Romeo or Sierra at delivery and remains so up to 1 year post loading.|prosthesis delivery, 1 year|78 patients were treated in total. 4 of the patients received two bridges (which is complaint with the protocol). Therefore there are more bridges than patients.||percentage of successful implants|Participants||Number
645232|NCT02186665|Primary|Success of Investigator's Global Assessment (IGA)|"The number of subjects with a minimum improvement of 2 grades from baseline in the IGA score and a severity rating of 0 (clear) of 1 (almost clear) at Week 8 (LOCF).
The IGA was evaluated at each visit on the following 0 to 4 point scale:
0 - Clear: No signs of psoriasis except for residual hypopigmentation / hyperpigmentation
- Almost Clear: Just perceptible erythema, no induration, and no scaling
- Mild: Mild erythema, no induration, and mild or no scaling
- Moderate: Moderate erythema, mild induration, and mild or no scaling
- Severe: Severe erythema, moderate to severe induration, and scaling of any degree"|Baseline to Week 8|ITT: All randomized subjects to whom study medication was dispensed.||Participants|||Count of Participants
645233|NCT02186587|Primary|Distance Measured During 6-minute Walk Test|Subjects will walk for 6 minutes and the distance covered will be measured in feet.|6 months|||feet||Standard Deviation|Mean
645234|NCT02186223|Secondary|Incidence of PEs Averted|During the pre-removal cavogram, the presence of significant clot (>25% of the volume of the filter) trapped by the Angel® Catheter will be assessed. The number of subjects with significant clot trapped by the device will be reported as the number of PEs averted.|During the pre-removal cavogram (An average of 6.8 days after device insertion)|||Participants|||Count of Participants
645235|NCT02186223|Secondary|Incidence of Major Bleeding Event||Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever occurs first (maximum of 33 assessment days with an anticipated average of 7 days)|||Participants|||Count of Participants
645236|NCT02186223|Secondary|Incidence of Catheter Related Blood Stream Infections||Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever occurs first (maximum of 33 assessment days with an anticipated average of 7 days)|||Participants|||Count of Participants
645237|NCT02186223|Secondary|Incidence of Catheter Related Thrombosis||Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever occurs first (maximum of 33 assessment days with an anticipated average of 7 days)|||Participants|||Count of Participants
645238|NCT02186223|Secondary|Incidence of Acute Proximal Deep Vein Thrombosis||Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever occurs first (maximum of 33 assessment days with an anticipated average of 7 days)|||Participants|||Count of Participants
645299|NCT02182895|Secondary|Variability in Glucose Levels|Mean amplitude of glycemic excursions|Days 2 to 5|Patients who allowed a CGMS.||mmol/L||Standard Deviation|Mean
645239|NCT02186223|Primary|Freedom From Clinically Significant PE or Fatal PE During Treatment Period|"Clinically Significant PE: Subjects will be assessed daily for signs and symptoms of PE. If present and no alternative diagnosis is suspected, at least one of four defined diagnostic examinations will performed to confirm or rule out PE.
Fatal PE: Defined as unexpected death within 24 hours of onset of the acute event with a verified initial symptomatic DVT or PE where there is no other reasonable cause of death."|Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever is first (maximum of 33 assessment days with an anticipated average of 7 days)|||Participants|||Count of Participants
645240|NCT02185729|Primary|Flow Mediated Dilation|Endothelium-dependent brachial artery flow-mediated dilation (FMD) was assessed. Ultrasound images of the brachial artery were obtained and arterial diameters were measured with customized software. Brachial artery FMD was calculated as (hyperemic diameter − 24 hour diameter)/24 hour diameter × 100.|24 hours after infusion|||percentage of brachial artery diameter||Standard Error|Mean
645241|NCT02185729|Primary|Flow Mediated Dilation|Endothelium-dependent brachial artery flow-mediated dilation (FMD) was assessed. Ultrasound images of the brachial artery were obtained and arterial diameters were measured with customized software. Brachial artery FMD was calculated as (hyperemic diameter − 4 hour diameter)/4 hour diameter × 100.|4 hours after infusion|||percentage of brachial artery diameter||Standard Error|Mean
645242|NCT02185729|Primary|Flow Mediated Dilation|Endothelium-dependent brachial artery flow-mediated dilation (FMD) was assessed. Ultrasound images of the brachial artery were obtained and arterial diameters were measured with customized software. Brachial artery FMD was calculated as (hyperemic diameter − baseline diameter)/baseline diameter × 100.|Baseline|||percentage of brachial artery diameter||Standard Error|Mean
645243|NCT02185534|Secondary|Pharmacokinetics of Clopidogrel by Assessment of Area Under the Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC(0-last))|Comparison of the pharmacokinetic profile in terms of the area under the plasma concentration-curve from time zero to the time of last quantifiable clopidogrel or SR26334 concentration, AUC(0-last), of clopidogrel sourced in Europe and the US.|0 hours (pre-dose), as well as at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 and 36 hours post-dose|The pharmacokinetic population consisted of 79 subjects, i.e. all subjects in the safety population for whom AUC(0-last) and Cmax could be calculated for clopidogrel for the test treatment (European) and at least one of the reference treatments (Japanese, US)||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
645244|NCT02185534|Primary|Pharmacokinetics of Clopidogrel by Assessment of Observed Maximum Plasma Concentration (Cmax)|Comparison of the pharmacokinetic profile in terms of observed maximum plasma concentration, taken directly from the individual concentration-time curve, Cmax, of clopidogrel sourced in Europe and the US.|0 hours (pre-dose), as well as at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 and 36 hours post-dose|The pharmacokinetic population consisted of 79 subjects, i.e. all subjects in the safety population for whom AUC(0-last) and Cmax could be calculated for clopidogrel for the test treatment (European) and at least one of the reference treatments (Japanese, US)||ng/mL||Geometric Coefficient of Variation|Geometric Mean
645245|NCT02185534|Primary|Pharmacokinetics of Clopidogrel by Assessment of Area Under the Curve From Time Zero Extrapolated to Infinity (AUC(0-inf))|Comparison of the pharmacokinetic profile in terms of plasma concentration-time curve from time zero extrapolated to infinity, AUC(0-inf), of clopidogrel sourced in Europe and Japan.|0 hours (pre-dose), as well as at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 and 36 hours post-dose|The pharmacokinetic population consisted of 79 subjects, i.e. all subjects in the safety population for whom AUC(0-last) and Cmax could be calculated for clopidogrel for the test treatment (European) and at least one of the reference treatments (Japanese, US). AUC(0-inf) could not be reliably calculated for many of these subjects.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
645246|NCT02185339|Other Pre-specified|Postoperative Pain|"Postoperative pain was measured by Visual Analogue Scale (VAS). Participants were asked to report their level of pain by pointing to a horizontal line, 10 cm in length. The scale (0-10 scores) was anchored by “no pain” (score of 0) and “pain as bad as it could be” (score of 10).
Measurements were made at postoperative (PO) 1h, PO 2h, PO 6h, PO 24h, and PO 48h."|Postoperative 2 days|||Scores on a scale||Standard Deviation|Mean
645247|NCT02185339|Other Pre-specified|Surgical Condition|Subjective rating of the view on the operating field was assessed by the surgeon who performed the surgery (optimal condition, good, acceptable, poor, extremely poor)|At completion of pneumoperitoneum surgery|||Participants|||Number
645248|NCT02185339|Other Pre-specified|Cardiac Index|"Was obtained from arterial pressure waveform analysis using the FloTrac™ sensor and the Vigileo™ monitor.
Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP."|intraoperative|||L/min/m^2||Standard Deviation|Mean
645249|NCT02185339|Other Pre-specified|Stroke Volume Variation|"Was calculated by taking '(maximum stroke volume - minimum stroke volume) / mean stroke volume' over a respiratory cycle using the FloTrac™ sensor and the Vigileo™ monitor.
Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP."|intraoperative|||% of mean stroke volume||Standard Deviation|Mean
645250|NCT02185339|Secondary|Pulmonary Shunt|"Was calculated using the formula: pulmonary shunt = (pulmonary capillary oxygen content - arterial oxygen content) / (pulmonary capillary oxygen content - venous oxygen content). Pulmonary capillary oxygen partial pressure is assumed to be equal to alveolar oxygen partial pressure.
Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP."|intraoperative|||% of shunt||Standard Deviation|Mean
645251|NCT02185339|Secondary|Estimated Dead Space|Was calculated from arterial blood and expired carbon dioxide analysis. Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP.|intraoperative|||% of respiratory dead space||Standard Deviation|Mean
645252|NCT02185339|Secondary|Arterial to End-tidal Partial Pressure of Carbon Dioxide Difference|Was calculated from arterial blood and expired carbon dioxide analysis. Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP.|intraoperative|||mmHg||Standard Deviation|Mean
645253|NCT02185339|Secondary|Arterial Oxygen Tension/Inspired Oxygen Fraction|Was calculated from arterial blood oxygen analysis. Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP.|intraoperative|||mmHg||Standard Deviation|Mean
645300|NCT02182895|Secondary|Incidence of Hyperglycemia (Blood Glucose >200 mg/dL)|Proportion of BG readings in the severe hyperglycemic range.|Days 2 to 5|completed||% of blood glucose readings >200|||Number
645254|NCT02185339|Primary|Thoracopulmonary Compliance|"Was measured with a patient spirometry monitor through a flow sensor.
Measurements were obtained at the following four time points: (1) 15 min after a patient positioning in lateral decubitus before inducing the pneumoperitoneum (T Lateral); (2) 1 h after pneumoperitoneum induction with the patient in the lateral decubitus position (T Lat+PP1h); (3) 2 h after pneumoperitoneum induction with the patient in the lateral decubitus position (T Lat+PP2h); and (4) at the end of surgery, 15 min after abdominal deflation in the lateral decubitus position (T EndPP)."|intraoperative|||ml/cmH2O||Standard Deviation|Mean
645255|NCT02185183|Primary|Number of Participants With Improved in Disease Activity||15 weeks|||participants|||Number
645256|NCT02185131|Primary|Level of Depressive Symptoms|Level of depressive symptoms, as indicated by the score on the Beck Depression Inventory. The Beck Depression Inventory II scoring range is as follows: 0-13 minimal depressive symptoms, 14-19 mild depressive symptoms, 20-28 moderate depressive symptoms and 29-63 severe depressive symptoms.|12 Weeks|||Units on a scale||Standard Deviation|Mean
645257|NCT02185131|Primary|Drinks Per Drinking Day|Level of drinking, as indicated by the number of drinks per day as recorded on the Timeline Follow-Back calendar.|12 Weeks|||Drinks per drinking day||Standard Deviation|Mean
645258|NCT02185105|Primary|Anterior Ocular Health - Conjunctival Staining (Inferior)|Conjunctival staining (inferior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).|baseline & 6hrs|||units on a scale||Standard Deviation|Mean
645259|NCT02185105|Primary|Anterior Ocular Health - Conjunctival Staining (Temporal)|Conjunctival staining (temporal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).|baseline & 6hrs|||units on a scale||Standard Deviation|Mean
645260|NCT02185105|Primary|Anterior Ocular Health - Conjunctival Staining (Superior)|Conjunctival staining (superior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).|baseline & 6hrs|||units on a scale||Standard Deviation|Mean
645261|NCT02185105|Primary|Anterior Ocular Health - Conjunctival Staining (Nasal)|Conjunctival staining (nasal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).|baseline & 6hrs|||units on a scale||Standard Deviation|Mean
645262|NCT02185105|Primary|Anterior Ocular Health - Corneal Staining (Inferior)|Corneal staining (inferior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= >45% of area)|baseline & 6hrs|||units on a scale||Standard Deviation|Mean
645263|NCT02185105|Primary|Anterior Ocular Health - CornealStaining (Superior)|Corneal staining (superior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= >45% of area)|baseline & 6hrs|||units on a scale||Standard Deviation|Mean
645264|NCT02185105|Primary|Anterior Ocular Health - Corneal Staining (Temporal)|Corneal staining (temporal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= >45% of area)|baseline & 6hrs|||units on a scale||Standard Deviation|Mean
645265|NCT02185105|Primary|Anterior Ocular Health - Corneal Staining (Nasal)|Corneal staining (nasal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= >45% of area)|baseline & 6hrs|||units on a scale||Standard Deviation|Mean
645266|NCT02185105|Primary|Anterior Ocular Health - Corneal Staining (Central)|Corneal staining (central) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= >45% of area)|baseline & 6hrs|||units on a scale||Standard Deviation|Mean
645267|NCT02185105|Primary|Lens Fitting - Rotation/Mislocation|Investigator's observed the rotation/mislocation (toric mark) of study lenses from the desired 6 o'clock position following temp rotation 30 degrees, 10 blinks; rotation toward desired 6 o'clock position=(+); rotation away from desired 6 o'clock position=(-).|Baseline, 15min & 6hrs|||degrees||Standard Deviation|Mean
645268|NCT02185105|Primary|General Lens Fit - Fit Acceptance|Investigator's assessment for fit acceptance of study lenses. Scale: 0-4 (0=Should not be worn; 4=Perfect)|15min & 6hrs|||units on a scale||Standard Deviation|Mean
645269|NCT02185105|Primary|Investigator's Assessment of Stability|Investigator's assessment of the study lenses overall stability difference measured from 0-180 degrees, 0=very good stability, 180=very bad stability.|15min & 6hrs|||degrees||Standard Deviation|Mean
645270|NCT02185105|Primary|Subjective Rating For Handling - Removal|Participant's subjective rating for ease of removal of study lenses. Scale (0-100; 0=could not remove lens from eye;100=always easy to place remove from eye)|1 min|||units on a scale||Standard Deviation|Mean
645271|NCT02185105|Primary|Subjective Rating For Handling - Insertion|Participant's subjective rating for ease of insertion of the study lenses. Scale (0-100; 0=could not place lens on eye;100=always easy to place lens on eye)|1 min|||units on a scale||Standard Deviation|Mean
645272|NCT02185105|Primary|Subjective Rating For Comfort Preference|Participant's subjective rating of comfort preference of study lenses. Scale: (Strongly Prefer Right lens - Strongly Prefer Left Lens)|1min, 15min, 3hrs, 6hrs|||percentage of subjects|||Number
645273|NCT02185105|Primary|Subjective Rating For Comfort - Comfort Since Last Visit|Participant's subjective rating of comfort now of study lenses. Surveyed at 15min, 3hr, and 6hr. Scale (0-100; 0=cannot be worn, causes pain, 100=cannot be felt ever)|15min, 3hrs, 6hrs|||units on a scale||Standard Deviation|Mean
645274|NCT02185105|Primary|Lens Surface Assessment of Study Lenses - Surface Acceptance|Investigator's objective assessment of surface acceptance at 15min and 6hrs. Rated on a scale (0-4; 0=very poor, 4=excellent)|15min & 6hrs|||units on a scale||Standard Deviation|Mean
645275|NCT02185105|Primary|Lens Surface Assessment of Study Lenses - Deposits|Investigator's objective assessment of lens surface deposition at 15min and 6hrs. Graded on the appearance of lens surface by slit lamp. Rated on a scale (0-4; 0=no deposits, 4=deposits ≥0.5mm or film > 75% of surface)|15min & 6hrs|||units on a scale||Standard Deviation|Mean
645276|NCT02185105|Primary|Lens Surface Assessment of Study Lenses - Surface Wettability|Investigator's objective assessment of lens surface wettability at 15min and 6hrs. Scale (0-4; 0=non-wetting, 4=Excellent)|15min & 6hrs|||units on a scale||Standard Deviation|Mean
645301|NCT02182895|Secondary|Incidence of Hypoglycemia (BG <70 mg/dL)|Number of BG readings <70 mg/dL in each group|Days 2 to 5|completed||number of events|||Number
645302|NCT02182895|Secondary|Dose of Insulin|Average daily amount of insulin used|Days 2 to 5|completed subjects||Units||Standard Deviation|Mean
645277|NCT02184624|Secondary|Percentage of Participants Who Overall Found the ELLIPTA Device Easy to Use Compared With Non-ELLIPTA Inhalers as Assessed by the Ease of Use Questionnaire|After completing the demonstration procedures of the inhalers, the HCP asked the participant a number of questions from ease of use questionnaire. Ease of use questionnaire consisted of six questions each for ELLIPTA inhaler and the other inhaler under study. Each question had one response to choose from 5 options of ease of use (Very easy, easy, neutral, difficult and very difficult). Based upon the response given by the participants the number of participants who rated ease of use higher for ELLIPTA, higher for non- ELLIPTA, or rated the same were reported|Day 1|Modified Intent-to-Treat Population.||Percentage of participants|||Number
645278|NCT02184624|Secondary|Percentage of Participants Who Overall Preferred the ELLIPTA Device Compared to Non-ELLIPTA Inhalers as Assessed by the Preference Questionnaire|After completing the demonstration procedures of the inhalers, the HCP asked the participant a number of questions from preference questionnaire. Preference questionnaire consisted of eight questions related to both inhalers used during the study. Each question had one response to choose from 3 preference options (Other inhaler device, ELLIPTA inhaler device and No preference). The number of participants who overall preferred the ELLIPTA device compared to non-ELLIPTA inhalers (First question in the preference questionnaire) were reported.|Day 1|Modified Intent-to-Treat population. Only participants who completed the questionnaire were included in the analysis.||Percentage of participants|||Number
645279|NCT02184624|Secondary|Number of Participants Needed Instructions From HCP (Maximum Three Times) to Demonstrate Adequate Inhalation Technique|If the participant made any error while demonstrating the use of the first inhaler after reading the patient instruction leaflet, the HCP demonstrated the correct usage of the inhaler to the participant. The participant was then asked to demonstrate inhaler use again. Any errors made by the participant were recorded by the HCP. The same procedure was repeated if the participant continues to make errors in the use of the inhaler. In total, the HCP demonstrated the use of the inhaler up to three times. Same procedure was followed for second inhaler. The number of participants who demonstrated the adequate inhalation technique after third time instructions from HCP was reported.|Day 1|Modified Intent-to-Treat Population||Participants|||Number
645280|NCT02184624|Secondary|Percentage of Participants Making at Least One Overall Error After the First Instruction From the HCP|An overall error includes a critical and non-critical error. If the participant made any error while demonstrating the use of the inhaler after reading the patient instruction leaflet, the HCP demonstrated the correct usage of the inhaler to the participant. The participants were then asked to demonstrate inhaler use again. If any further error was made by the participant was recorded by HCP.|Day 1|Modified Intent-to-Treat Population.||Percentage of participants|||Number
645281|NCT02184624|Secondary|Percentage of Participants Making at Least One Critical Error After the First Instruction From the HCP|A critical error was defined as an error that was most likely to result in no or only minimal medication being inhaled. The errors considered as critical errors while handling the inhaler devices were failed to open cover, lever was not pushed back, shook the device after dose preparation, exhaled directly into mouthpiece, no seal by the lips round the mouthpiece during the inhalation. As per the crossover study design participants received placebo via the ELLIPTA inhaler first and then non-ELLIPTA inhaler or non-ELLIPTA inhaler first and then ELLIPTA on Day 1. If the participant made any error while demonstrating the use of the inhaler after reading the patient instruction leaflet, the HCP demonstrated the correct usage of the inhaler to the participant. The participants were then asked to demonstrate inhaler use again. If any further critical error were made by the participant, the error were recorded by HCP.|Day 1|Modified Intent-to-Treat Population||Percentage of participants|||Number
645282|NCT02184624|Secondary|Percentage of Participants Who Made at Least One Overall Error After Reading the Patient Information Leaflet|An overall error includes a critical and non-critical error. Any error made by the participants while demonstrating the use of the inhaler after reading the patient instruction leaflet was recorded by health care professional (HCP). The percentage of participants who made at least one overall error was reported. As per the crossover study design participants received placebo via the ELLIPTA inhaler first and then non-ELLIPTA inhaler or non-ELLIPTA inhaler first and then ELLIPTA on Day 1.|Day 1|Modified Intent-to-Treat Population.||Percentage of participants|||Number
645283|NCT02184624|Primary|Percentage of Participants Who Made at Least One Critical Error After Reading the Patient Information Leaflet|A critical error was defined as an error that was most likely to result in no or only minimal medication being inhaled. The errors considered as critical errors while handling the inhaler devices were failed to open cover, lever was not pushed back, shook the device after dose preparation, exhaled directly into mouthpiece, no seal by the lips round the mouthpiece during the inhalation. As per the crossover study design participants received placebo via the ELLIPTA inhaler first and then non-ELLIPTA inhaler or non-ELLIPTA inhaler first and then ELLIPTA on Day 1. The percentage of participants who made at least one critical error was reported for each inhaler regardless sequence.|Day 1|Modified Intent-to-Treat Population comprised of all participants in the Intent-to-Treat Population who completed demonstration of using both study inhaler devices after reading patient information leaflet.||Percentage of participants|||Number
645284|NCT02184494|Other Pre-specified|Fatigue/Depression Assessment|"Fatigue Severity Scale: 9-item, self-reporting rating that rates the severity of your fatigue symptoms on a Likert scale ranging from 1 to 7, with 1 indicating strong disagreement, and 7 indicating strong agreement. The sum of scores is calculated. The lower the score, the more severe the participant's fatigue symptoms.
Beck's Depression Inventory: 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression on a Likert scale ranging from 0 to 3, with 3 being the most severe. The sum of scores is calculated. A high score indicates more severe depression and related symptoms."|Collected at the same time as the other questionnaires. Lasted approximately 5-7 minutes.|2 of the 8 healthy, older adults did not complete all of the surveys, and were thus unable to be added to analysis.||units on a scale||Standard Deviation|Mean
645303|NCT02182895|Secondary|Percentage of Blood Glucose Readings in 70-140 mg/dL Range|Percentage of BG readings in the desired range of 70-140 mg/dl out of all avaialble BG readings.|Days 2 to 5|completed subjects||% of blood glucose readings|||Number
645304|NCT02182895|Primary|Mean Daily Blood Glucose Levels During Hospital|mean of average daily blood blood glucose for each patient day|Hospital days 2-5|Inpatients with diabetes||mg/dL||Standard Deviation|Mean
648286|NCT02107014|Primary|Change in IL-1β From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].|||pg/mL||95% Confidence Interval|Median
645285|NCT02184494|Other Pre-specified|Health and Activity Questionnaire|"Short Form 36 Health Survey questionnaire: patient-reported survey of 36 questions, yielding the participant’s degree of health on 8 different scale scores (each scale summed into a 0-100 score, with lower scores indicating more disability). The eight scales include vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health.
Schwab and England Activities of Daily Living Questionnaire: self-rated, single item assessment of the participant’s ability to perform daily activities with speed and independence, measured using a Likert scale of percentages, in 10% increments. A score of 100% indicates total independence, while 0% indicates complete dependence."|Collected immediately after the UPDRS (if PD population), or immediately after the resting energy expenditure measurement (if MS or healthy, older adult). Measured with other questionnaires and immediately before squatting exercise. Lasted ~10 minutes.|2 of the 8 healthy, older adults did not complete all of the surveys, and were thus, clearly unable to be added to analysis.||units on a scale||Standard Deviation|Mean
645286|NCT02184494|Other Pre-specified|Neurological Function|Neurological functional state will be assessed using the Unified Parkinson's Disease Rating Scale (UPDRS). Of the 5 sections of the examination, two parts were used. Part II (self-evaluation of aspects of the experiences of daily living) consisted of 13 Likert scale questions (graded 0 to 4, with 4 being most severe), including speech, saliva and drooling, chewing and swallowing, eating tasks, dressing, hygiene, handwriting, doing hobbies and other activities, turning in bed, tremor, getting out of bed/car/deep chair, walking and balance, and freezing. Part III (motor evaluation performed by trained research personnel) consisted of 14 Likert scale questions (graded 0 to 4, with 4 being most severe), including speech, facial expression, rigidity, finger tapping, hand movements, pronation-supination movements of hands, toe tapping, leg agility, arising from chair, gait, etc... Values were summed, with higher values indicating increased impairment and disability.|Measured immediately after the resting energy expenditure measurement, and before the other questionnaires. Lasted approximately 15 minutes.|The MS and healthy, older adults populations were not required to be assessed with the UPDRS because the assessment materials were for PD populations, specifically.||units on a scale||Standard Deviation|Mean
645287|NCT02184494|Secondary|Resting Energy Expenditure|Measured using using indirect calorimetry with a ventilated face mask and noseclip (Parvometrics, Sandy, UT). This involves laying supine for 30 to 60 minutes.|Measured immediately upon arriving to the laboratory. Lasted approximately 25 minutes.|"1 of the 12 PD participants had severe claustrophobia, and could not tolerate the breathing mask on their face.
1 of the 12 PD participants, and 1 of the 8 healthy, older adults participants: dysfunctional equipment, and thus invalid results."||kcal||Standard Deviation|Mean
645288|NCT02184494|Primary|Blood Lactate Response|Measured using a blood lactate analyzer, a finger prick test measured before, after, and 10 minutes after exercise|Before, immediately after, and 10 minutes after the squatting exercise protocol|"2 of the 8 participants in the healthy, older adults group did not return for this visit, and thus, were not included in analysis.
1 of the 12 MS participants did not return for this visit, and thus, were not included in analysis."||mmol/L||Standard Deviation|Mean
645289|NCT02183675|Primary|Area Under the Plasma Concentration Curve at Steady State for HCTZ|Area under the plasma concentration curve (AUC) of HCTZ in plasma at steady state over the dosing interval tau|15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h and 48h after 10 days drug administration|PK set||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
645290|NCT02183675|Primary|Maximum Measured Concentration (Cmax) at Steady State for HCTZ|Maximum measured concentration (Cmax) of HCTZ in plasma at steady state over the dosing interval tau|15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h and 48h after 10 days drug administration|PK set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
645291|NCT02183675|Primary|Area Under the Plasma Concentration Curve at Steady State for Amlodipine|Area under the plasma concentration curve (AUC) of amlodipine in plasma at steady state over the dosing interval tau|15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h, 96h, 120h and 144h after 10 days drug administration|PK set||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
645292|NCT02183675|Primary|Maximum Measured Concentration (Cmax) at Steady State for Amlodipine|Maximum measured concentration (Cmax) of amlodipine in plasma at steady state over the dosing interval tau|15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h, 96h, 120h and 144h after 10 days drug administration|PK set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
645293|NCT02183675|Secondary|Amount of HCTZ Excreted in Urine at Steady State From 0 to 24 Hours|Amount of HCTZ excreted in urine over the time interval from 0 to 24 hours at steady state|0-6 hours (h), 6-12h and 12-24h after drug administration on day 10|PK set||mg||Geometric Coefficient of Variation|Geometric Mean
645294|NCT02183675|Primary|Area Under the Plasma Concentration Curve at Steady State for Telmisartan|Area under the plasma concentration curve (AUC) of telmisartan in plasma at steady state over the dosing interval tau|15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h and 72h after 10 days drug administration|PK set||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
645295|NCT02183675|Primary|Maximum Measured Concentration (Cmax) at Steady State for Telmisartan|Maximum measured concentration (Cmax) of telmisartan in plasma at steady state over the dosing interval tau|15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h and 72h after 10 days drug administration|Pharmacokinetic (PK) set which included all subjects in the treated set who had evaluable PK variable of test (T80/A5/H12.5 mg) and at least one of two references (T80/H12.5 mg and T80/A5 mg) for treatment periods 1, 2, and 3. Subjects who had a protocol deviation relevant to the evaluation of relative bioavailability were excluded.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
645296|NCT02183519|Primary|Peak Expiratory Flow Rate|Peak expiratory flow rate is the maximum volume of air that is expelled per unit time for each cough in a cough epoch. Measured in liters/second.|1-2 hours|||Liters of air/second||Standard Deviation|Mean
645305|NCT02181790|Primary|Change in Dermatology Life Quality Index (DLQI) at Week 8 From Baseline|reduction in DLQI from baseline after 16 treatments with the excimer laser in the first phase of the study|baseline and week 8|study terminated before study completion, no data collected|||||
645306|NCT02181790|Primary|Psoriasis Area and Severity Index (PASI)|The percentage of patients achieving a 75% reduction in the Psoriasis Area and Severity Index (PASI) from baseline after 16 treatments with the excimer laser in the first phase of the study.|baseline and week 12|study terminated before study completion, no data collected|||||
645307|NCT02181530|Secondary|Time to OZURDEX® Re-Injection in the Study Eye||Up to 17 Months|All participants who had OZURDEX® re-injection.||days||Standard Deviation|Mean
645308|NCT02181530|Secondary|Time to Improvement of 3 Lines or More in BCVA in the Study Eye|BCVA following the injection of OZURDEX® is measured in the study eye using a special eye chart. BCVA measurements expressed in Snellen fractions were converted to logMAR units and approximate ETDRS letter scores based on the formula: approximate ETDRS letters = 85 + 50 x log10 (Snellen fraction). The converted scores hereinafter are referred to as “approxETDRS letters” to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. It was assumed that one line equals five ETDRS points. The time in days to improvement of 3 or more lines is reported.|Baseline, Up to 17 Months|All participants with improvement of 3 lines or more in BCVA.||days||Standard Deviation|Mean
645309|NCT02181530|Secondary|Time to Improvement of 2 Lines or More in BCVA in the Study Eye|BCVA following the injection of OZURDEX® is measured in the study eye using a special eye chart. BCVA measurements expressed in Snellen fractions were converted to logMAR units and approximate ETDRS letter scores based on the formula: approximate ETDRS letters = 85 + 50 x log10 (Snellen fraction). The converted scores hereinafter are referred to as “approxETDRS letters” to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. It was assumed that one line equals five ETDRS points. The time in days to improvement of 2 or more lines is reported.|Baseline, Up to 17 Months|All participants with improvement of 2 lines or more in BCVA.||days||Standard Deviation|Mean
645310|NCT02181530|Secondary|Change From Baseline in Retinal Thickness as Measured by Optical Coherence Tomography (OCT)|OCT is measured in the study eye following each injection of OZURDEX®. OCT is a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina to assess retinal thickness. A negative change indicates an improvement|Baseline, 7 to 12 weeks following the first OZURDEX® injection|All participants with data available at the given time-point.||μm||Standard Deviation|Mean
645311|NCT02181530|Secondary|Percentage of Patients With an Increase of 3 Lines or More in BCVA in the Study Eye|BCVA following the injection of OZURDEX® is measured in the study eye using a special eye chart. BCVA measurements expressed in Snellen fractions were converted to logMAR units and approximate ETDRS letter scores based on the formula: approximate ETDRS letters = 85 + 50 x log10 (Snellen fraction). The converted scores hereinafter are referred to as “approxETDRS letters” to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. It was assumed that one line equals five ETDRS points. An increase of 3 lines or more indicates an improvement.|Baseline, Up to 17 Months|All participants.||percentage of participants|||Number
645312|NCT02181530|Secondary|Percentage of Patients With an Increase of 2 Lines or More in BCVA in the Study Eye|BCVA following the injection of OZURDEX® is measured in the study eye using a special eye chart. BCVA measurements expressed in Snellen fractions were converted to logMAR units and approximate Early Treatment Diabetic Retinopathy Study (ETDRS) letter scores based on the formula: approximate ETDRS letters = 85 + 50 x log10 (Snellen fraction). The converted scores hereinafter are referred to as “approxETDRS letters” to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. It was assumed that one line equals five ETDRS points. An increase of 2 lines or more indicates an improvement.|Baseline, Up to 17 Months|All participants.||percentage of participants|||Number
645313|NCT02181530|Primary|Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA is measured in the study eye following each injection of OZURDEX® using a special eye chart. The number of letters read correctly Snellen fraction are converted to a decimal scale. There are 11 lines on a standard Snellen chart ranging from 0.1 (20/200) at worst to 2.0 (20/10) at best. 20/20 on the decimal scale is equal to 1.0. The lower the number of letters read correctly on the eye chart (lower number on the decimal scale) the worse the vision (or visual acuity). The higher the number of letters read correctly (higher number on the decimal scale), the better the vision (or visual acuity). A positive number improvement in the number of letters read means that the vision has improved.|Baseline, 7 to 12 weeks following the first OZURDEX® injection|All participants with data available at the time-point.||units on a scale||Standard Deviation|Mean
645314|NCT02181517|Secondary|Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye|CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from Baseline indicated improvement.|Baseline, Week 16, Week 20|mITT population included all randomized and treated participants with at least 1 follow-up visit.||microns||Standard Deviation|Mean
645315|NCT02181517|Secondary|Percentage of Patients With a BCVA Gain of 10 or More Letters in the Study Eye Using the ETDRS Scale|BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|Baseline, Week 20|mITT population included all randomized and treated participants with at least 1 follow-up visit.||percentage of participants|||Number
645316|NCT02181517|Secondary|Percentage of Patients With a BCVA Gain of 15 or More Letters in the Study Eye Using the ETDRS Scale|BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|Baseline, Week 20|mITT population included all randomized and treated participants with at least 1 follow-up visit.||percentage of participants|||Number
645317|NCT02181517|Secondary|Change From Baseline in BCVA in the Study Eye at Week 20 Using the ETDRS Scale|BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|Baseline, Week 20|mITT population included all randomized and treated participants with at least 1 follow-up visit.||letters||Standard Deviation|Mean
645318|NCT02181517|Primary|Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 16 Using the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale|BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|Baseline, Week 16|Modified Intent-to-Treat (mITT) population included all randomized and treated participants with at least 1 follow-up visit.||letters||Standard Deviation|Mean
645319|NCT02181504|Secondary|Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye|CRT is assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system that provides high-resolution imaging sections of the retina. SD-OCT is performed in the study eye after pupil dilation. A negative change from Baseline indicates improvement and a positive change from baseline indicates worsening.|Baseline, Week 16, Week 20|Modified Intent-to-Treat: all randomized and treated patients with at least 1 follow-up visit||microns||Standard Deviation|Mean
645320|NCT02181504|Secondary|Percentage of Patients With a BCVA Gain of ≥10 Letters in the Study Eye on the ETDRS Scale|BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The percentage of patients with a BCVA gain of ≥10 letters are noted.|Baseline, 20 Weeks|Modified Intent-to-Treat: all randomized and treated patients with at least 1 follow-up visit||Percentage of Patients|||Number
645321|NCT02181504|Secondary|Percentage of Patients With a BCVA Gain of ≥15 Letters in the Study Eye on the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale|BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The percentage of patients with a BCVA gain of ≥15 letters are noted.|Baseline, 20 Weeks|Modified Intent-to-Treat: all randomized and treated patients with at least 1 follow-up visit||Percentage of Patients|||Number
645322|NCT02181504|Secondary|Change From Baseline in BCVA in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase (positive number change from baseline) in the number of letters read correctly means that vision has improved and a decrease (negative number change from baseline) in the number of letters read correctly means that vision has worsened.|Baseline, Week 20|Modified Intent-to-Treat: all randomized and treated patients with at least 1 follow-up visit||Letters||Standard Deviation|Mean
645323|NCT02181504|Primary|Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase (positive number change from baseline) in the number of letters read correctly means that vision has improved and a decrease (negative number change from baseline) in the number of letters read correctly means that vision has worsened.|Baseline, Week 16|Modified Intent-to-Treat: all randomized and treated patients with at least 1 follow-up visit||Letters||Standard Deviation|Mean
645324|NCT02181387|Primary|Neuraxial Analgesic Drug Consumption Per Hour|subject evaluated every 2 hours with the amount of neuraxial analgesia consumed during that time period. Study med administered up to 24 hours. labor analgesia continue until delivery.|up to 24 hours|||milliliters||Standard Deviation|Mean
645325|NCT02181140|Secondary|Complication Rates|Complication rates of EUS FNA|day 0 and day 14|||participants|||Number
645326|NCT02181140|Secondary|EUS Pro Core FNA: Histology Samples|Histology (not cytology) samples for Pro-core Needle: Number of adequately evaluable histology samples|day 0 and day 14|Histology (not cytology) samples for Pro-core Needle||participants|||Number
645327|NCT02181140|Primary|Diagnostic Accuracy|"Diagnostic accuracy of Pro-core needle (22 G) will be compared to conventional fine needle aspiration (22 G). Therefore EUS-FNA with both needles is undertaken in a random order in each lesion. For Pro-core needle, a histological / cytological diagnosis and quality assessment will be made by pathologists.For Echotip aspiration needle, reference cytology evaluation is done by cytology experts.
The histopathological diagnosis after surgery or the clinical follow up of at least one year after EUS FNA is current standard."|up to 1 year|||Diagnostic accuracy (%)|||Number
645328|NCT02181127|Secondary|Documented Episodes of Nausea and Fraction on Glucagon vs. Placebo Days||2 weeks||||||
645329|NCT02181127|Secondary|Total Glucagon Dosing (mcg/kg/24 Hours)||2 weeks||||||
645330|NCT02181127|Secondary|Total Number of Grams of Carbohydrate Taken for Hypoglycemia Overnight (11:00 PM – 7:00 AM)||2 weeks||||||
645331|NCT02181127|Secondary|Number of Carbohydrate Interventions for Hypoglycemia Overnight (11:00 PM – 7:00 AM)||2 weeks||||||
645332|NCT02181127|Secondary|Total Number of Grams of Carbohydrate Taken for Hypoglycemia During the Daytime (7:00 AM – 11:00 PM)||2 weeks||||||
645333|NCT02181127|Secondary|• Number of Carbohydrate Interventions for Hypoglycemia During the Daytime (7:00 AM – 11:00 PM)||2 weeks||||||
645334|NCT02181127|Secondary|Insulin Total Daily Dose||2 weeks||||||
645335|NCT02181127|Secondary|Total Number of Grams of Carbohydrate Taken for Hypoglycemia||2 weeks||||||
645336|NCT02181127|Secondary|Number of Carbohydrate Interventions for Hypoglycemia||2 weeks||||||
645337|NCT02181127|Secondary|• Fraction of BG Values < 70 During Exercise Fraction of BG Values < 70 During Exercise||2 weeks||||||
645338|NCT02181127|Secondary|Mean BG During Exercise||2 weeks||||||
645339|NCT02181127|Secondary|Fraction Measurements Within Each of the Following Glucose Ranges as Determined From HemoCue Measurements Taken Before Meals and Before Bed: < 70 mg/dl,70-120 mg/dl,70-180 mg/dl,>180 mg/dl,>250 mg/dl||2 weeks||||||
645340|NCT02181127|Secondary|Percentage of Study Days With Mean BG < 154 mg/dl||2 weeks||||||
645341|NCT02181127|Secondary|Percentage of All BG Values Less Than 70 mg/dl||2 weeks||||||
645342|NCT02181127|Secondary|Percentage of the Above Subset of BG Values Less Than 70 mg/dl||2 weeks||||||
645349|NCT02181127|Secondary|Fraction of Time Spent Within Each of the Following Glucose Ranges as Determined From All CGMG Measurements.|"Measurements adjusted for the frequency of measurement (i.e. modeled so that more frequent measurements at the time of hypoglycemia and exercise will not skew the mean):
< 70 mg/dl,70-120 mg/dl,70-180 mg/dl, >180 mg/dl, >250 mg/dl"|2 weeks||||||
645350|NCT02181127|Secondary|Number of Hypoglycemic Episodes With CGMG < 70 mg/dl||2 weeks||||||
645351|NCT02181127|Secondary|Number of Hypoglycemic Episodes With CGMG < 60 mg/dl||2 weeks||||||
645352|NCT02181127|Secondary|Number of Hypoglycemic Episodes With CGMG < 50 mg/dl||2 weeks||||||
645353|NCT02181127|Secondary|Time With CGM Glucose Less Than 70 mg/dl Overnight and During Daytime||2 weeks||||||
645354|NCT02181127|Primary|Continuous Glucose Monitor (CGM) Glucose Total Area Over the Curve and Less Than 60 mg/dl||From t=0 to study stop after 2 weeks|||mg/dl/min||Standard Deviation|Mean
645355|NCT02180893|Secondary|Participant Satisfaction Score|Participants were asked to score their satisfaction with their postoperative pain control on a scale of 0 (least satisfied) to 10 (most satisfied)|48 hours|||units on a scale||Standard Deviation|Mean
645356|NCT02180893|Secondary|Participant Satisfaction|Participants were asked whether or not they were satisfied with their postoperative pain control (yes or no)|48 hours|||"percentage of yes responders"|||Number
645357|NCT02180893|Primary|Visual Analog Scale (VAS) Pain Scores|Possible scores range from 0-10, with 0 being no pain and 10 being highest level of pain|24 hours|||units on a scale||Standard Deviation|Mean
645358|NCT02180893|Primary|Postoperative Fentanyl||24 hours|||microgram/kilogram||Standard Deviation|Mean
645359|NCT02180828|Secondary|Total Adverse Events|Total adverse events(cases)|at day 7-14 follow up|||participants|||Number
645360|NCT02180828|Secondary|Adverse Events 4|Skin sensitivity, urticaria rash, erythematous rash, irritation|at day 7-14 follow up|||participants|||Number
645361|NCT02180828|Secondary|Adverse Events 3|Gastrointestinal tract: abdominal pain, diarrhoea, nausea|at day 7-14 follow up|||participants|||Number
645362|NCT02180828|Secondary|Adverse Events 2|Vulvovaginal pruritus, burning, irritation, and bleeding|at day 7-14 follow up|||participants|||Number
645363|NCT02180828|Secondary|Adverse Events 1|Systemic: weak, palpitation, tachycardia, migraine, headache, dizzy, rhinorrhea, numb, dizziness, fatigue.|at day 7-14 follow up|||participants|||Number
645364|NCT02180828|Primary|Therapeutic Efficacy 4|Mycological cure of clotrimazole group and fluconazole group: Mycological cure or failure was referred to as Candida negative or positive,respectively, on Candida culture at follow-up visits.|at days30-35 follow-up|||participants|||Number
645365|NCT02180828|Primary|Therapeutic Efficacy 3|Mycological cure of clotrimazole group and fluconazole group|at days 7-14 follow-up|||participants|||Number
645366|NCT02180828|Primary|Therapeutic Efficacy 2|The clinical cure rates of clotrimazole and fluconazol|at days 30-35 follow-up|||participants|||Number
645367|NCT02180828|Primary|Therapeutic Efficacy 1|The clinical cure rates of clotrimazole and fluconazol: Clinical cure was defined as the resolution of symptoms present at baseline with a total severity score of ≤2. Improvement was defined as considerable reduction in the severity of baseline signs and symptoms with a decrease in the total score by ≥50%.Patients not clinically cured or showing improvement were considered clinical failures.|7-14 days after treatment (=visit 2)|PPS||participants|||Number
645368|NCT02180646|Other Pre-specified|Post-meal Glucagon-like Peptide-1 (GLP-1) Level (AUC [0-4])|Blood samples taken after breakfast and lunch|0 and 5, 10, 15, 20, 30, 40, 50, 60, 75, 90, 120,150, 180, 210, 240, 245, 250, 255, 260, 265, 270, 280, 280, 290, 300, 315, 330, 360, 390, 420, 450, 480 minutes following breakfast, and the same time points following lunch||||||
645369|NCT02180646|Other Pre-specified|Post-meal Insulin Level (AUC [0-4])|Blood samples taken after breakfast and lunch|0 and 5, 10, 15, 20, 30, 40, 50, 60, 75, 90, 120,150, 180, 210, 240, 245, 250, 255, 260, 265, 270, 280, 280, 290, 300, 315, 330, 360, 390, 420, 450, 480 minutes following breakfast, and the same time points following lunch|||min*pg/ml||Standard Error|Mean
645370|NCT02180646|Secondary|Post-meal Level of Glucose-dependent Insulinotropic Peptide (GIP) (AUC [0-4])|Blood samples taken after breakfast and lunch|0 and 5, 10, 15, 20, 30, 40, 50, 60, 75, 90, 120,150, 180, 210, 240, 245, 250, 255, 260, 265, 270, 280, 280, 290, 300, 315, 330, 360, 390, 420, 450, 480 minutes following breakfast, and the same time points following lunch|||min*pg/ml||Standard Error|Mean
645371|NCT02180646|Primary|Plasma Glucose Level Post-meal (AUC [0-4])|Blood samples taken after breakfast and lunch|0 and 5, 10, 15, 20, 30, 40, 50, 60, 75, 90, 120,150, 180, 210, 240, 245, 250, 255, 260, 265, 270, 280, 280, 290, 300, 315, 330, 360, 390, 420, 450, 480 minutes following breakfast, and the same time points following lunch|||min*pg/ml||Standard Error|Mean
645372|NCT02180230|Secondary|Cumulative Survival Rates of the Implants|An implant was reported to be a surviving implant when it remained in the jaw and was functionally loaded even if not all the individual success criteria were fulfilled (i) an implant that causes no allergic, toxic or gross infectious reactions either locally or systemically, ii) offered anchorage to a functional prosthesis, iii) showed no signs of fracture or bending, iv) showed no signs of peri-implant radiolucency on an intraoral radiograph using a paralleling technique strictly perpendicular to the implant-bone interface, and v) showed no mobility when individually tested by either tapping or rocking with a hand instrument).|implant insertion to follow-up visits (6, 12, 36 and 60 months)|Intention to treat analysis (all participants who received at least one implant were analyzed). Missing data was not imputed and not included in evaluation.||percentage of surviving implants|Participants||Number
645373|NCT02180230|Primary|Marginal Bone Remodeling|"Marginal bone remodeling is calculated for each side of the implant (mesial and distal) separately, as the difference between bone levels at two time points. The average of mesial and distal remodeling is then calculated for each implant site (paired for each side between two different points). Negative numbers indicate bone loss. Implant insertion was defined as a baseline.
Missing data was not imputed and not included in evaluation."|from implant insertion to 6, 12, 36 and 60 months|Intention to treat analysis (all participants who received at least one implant were analyzed). Missing data was not imputed and not included in evaluation.||mm|Participants|Standard Deviation|Mean
645512|NCT02175212|Primary|Biochemical Disease Free Survival: Estimated Percentage of Participants With Biochemical Disease-free Survival at 5 Years|Biochemical relapse was defined as the time from inclusion in the study (randomization) until the patient meets criteria for Biochemical failure (Phoenix criteria: PSA nadir plus 2 ng/ml).|5 years|||percentage of patients||95% Confidence Interval|Number
645374|NCT02180061|Secondary|ORR Per Central Radiology Review Using Immune-related Response Criteria (irRC)|The ORR, using irRC, was defined as the percentage of participants in the analysis population who had a confirmed Complete Response (irCR; complete disappearance of all tumor lesions, whether measureable or not, and no new lesions) or a Partial Response (irPR; decrease in sum of the products of the 2 largest perpendicular diameters of 50% or greater) at any time during the study, based on central radiology review.|Up to 24 months|The FAS population consisted of all allocated participants who had irRC measurable lesions at the Baseline scan as assessed by central independent radiology review and received at least one dose of study drug.||Percentage of Participants||95% Confidence Interval|Number
645375|NCT02180061|Secondary|ORR Per Investigator Assessment Using RECIST 1.1|The ORR, using RECIST 1.1 criteria, was defined as the percentage of participants in the analysis population who had a confirmed Complete Response (CR; disappearance of all target lesions) or Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions) at any time during the study, based on Investigator assessment.|Up to 24 months|The FAS population consisted of all allocated participants who had measurable lesions at the Baseline scan as assessed by Investigator review and received at least one dose of study drug.||Percentage of Participants||95% Confidence Interval|Number
645376|NCT02180061|Primary|Overall Response Rate (ORR) Per Central Radiology Review Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1|The ORR, using RECIST 1.1, was defined as the percentage of participants in the analysis population who had a confirmed Complete Response (CR; disappearance of all target lesions) or Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions) at any time during the study, based on central radiology review.|Up to 24 months|The Full Analysis Set (FAS) population consisted of all allocated participants who had measurable lesions at the Baseline scan as assessed by central radiology review and received at least one dose of study drug.||Percentage of Participants||95% Confidence Interval|Number
645377|NCT02180061|Primary|Number of Participants Discontinuing Treatment Due to AEs|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.|Up to last dose of study drug (Up to 24 months)|The APaT population consisted of all participants who received at least one dose of study drug.||Participants|||Number
645378|NCT02180061|Primary|Number of Participants Experiencing Adverse Events (AEs)|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.|All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)|The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.||Participants|||Number
645383|NCT02179424|Secondary|Smoking Reduction|Reduced at least 50% of cigarette consumption|6 month follow-up and 12 month follow-up|||participants|||Number
645384|NCT02179424|Primary|Smoking Quit Rate|smoking quit rate was defined as the self-reported 7-day point prevalence abstinence|6 month follow-up and 12 month follow-up|In Phase 2, a sample of 642 employees enrolled in the study and chose 1 among the 4 conditions for smoking cessation.||participants|||Number
645385|NCT02179424|Primary|Employers' KAP|"A questionnaire aimed to examine the employers'/ managerial staff’s knowledge, attitudes and practices in promoting smoking cessation in the workplace.
The questionnaires consist of three parts:
Employers's knowledge was assessed by measuring the average number of correct answers on questions about smoking and quitting (Scale 1-7).
Employers' attitude was assessed by measuring the average number agreeing items about their willingness to support employees to quit which included implementation of measures to show support for smoking cessation in the workplace or participation in smoking cessation programme (Scale 1-17).
Employers' practice was assessed by the level of smoking ban in the workplace as reported by the employer. (Scale 1-4; 1: not prohibited, 2: prohibited by not strictly, 3: Strictly prohibited and 4: absolutely strictly prohibited)."|Before the health talk|In Phase 1, questionnaires were sent out to 580 companies and 292 of the company employers returned the complete questionnaire. These 292 employers were not participating in the Phase 2 of this study.||units on a scale||Standard Deviation|Mean
645386|NCT02179398|Secondary|Specificity of Standard Biological Marker for SBI|Specificity of standard biological marker for SBI: WBC ≥ 15'000/mm³ and/or bands ≥ 1’500/mm³ and/or CRP ≥ 40 mg/L|at 72 hours from PED presentation|||percentage of patients (specificity)||95% Confidence Interval|Number
645387|NCT02179398|Secondary|Sensitivity of Standard Biological Marker for SBI|Sensitivity of standard biological marker for SBI: WBC ≥ 15’000/mm³ and/or bands ≥ 1’500/mm³ and/or CRP ≥ 40 mg/L|at 72 hours from PED presentation|||percentage of patients (sensitivity)||95% Confidence Interval|Number
645388|NCT02179398|Secondary|Specificity of a Lab-score ≥ 3||at 72 hours from PED presentation|||percentage of patients (specificity)||95% Confidence Interval|Number
645389|NCT02179398|Secondary|Sensitivity of a Lab-score ≥ 3||at 72 hours from PED presentation|||percentage of patients (sensitivity)||95% Confidence Interval|Number
645390|NCT02179398|Secondary|Hospitalization Rate||at PED presentation|||participants|||Number
645391|NCT02179398|Secondary|Presence of Serious Bacterial Infection||at 72 hours from PED presentation|||participants|||Number
645393|NCT02178995|Post-Hoc|Hit Reaction Time (Open-Label)|"Hit reaction time represents the average number of milliseconds required for a participant to respond to target stimuli. There are no meaningful absolute minimum or maximum scores, though 101ms is the current fastest verified response time per our review. A higher score is WORSE.
This was not a pre-specified variable or an intentional post-hoc analysis, but it is calculated automatically and included here only for completeness of data submission."|Visits 2 vs 3 vs 4 on randomized medication doses.|||Milliseconds||Standard Deviation|Mean
645394|NCT02178995|Post-Hoc|Hit Reaction Time (Double Blind)|"Hit reaction time represents the average number of milliseconds required for a participant to respond to target stimuli. There are no meaningful absolute minimum or maximum scores, though 101ms is the current fastest verified response time per our review. A higher score is WORSE.
This was not a pre-specified variable or an intentional post-hoc analysis, but it is calculated automatically and included here only for completeness of data submission."|Visits 2 vs 3 vs 4 on randomized medication doses.|||ms||Standard Deviation|Mean
645395|NCT02178995|Post-Hoc|Remaining CPT Variables (Double-blind Portion)|"Remaining CPT variables are automatically calculated by the program. They were not pre-specified variables of interest nor intentional post-hoc analyses. They are included ONLY for completeness of data submission.
Hit reaction time represents to the average number of milliseconds required for a participant to respond to target stimuli. There are no meaningful absolute minimum or maximum scores, though 101ms is the current fastest verified response time per our review. A higher score is WORSE.
Variability refers to variations in response time across individual blocks of time within the trial. It differs from HRTSD in that HRTSD measures variability across the entire trial. Minimum is 0. There are no absolute maximums. A higher score is WORSE.
Perseverations are errors made either faster than physiologically possible (<100ms). Minimum is 0, there is no maximum. Higher scores are WORSE."|Placebo vs 10mg vs 20mg (visits 2, 3, 4)|||Units||Standard Deviation|Mean
645396|NCT02178995|Post-Hoc|Remaining CPT Variables (Open-label)|"These are automatically-calculated CPT variables which were not pre-specified variables of interest or intentional post-hoc analyses. They are included ONLY for completeness of data. They include hit reaction time (HRT), variability (VAR), and perseverations (PRS).
Hit reaction time represents to the average number of milliseconds required for a participant to respond to target stimuli. There are no meaningful absolute minimum or maximum scores, though 101ms is the current fastest verified response time per our review. A higher score is WORSE.
Variability refers to variations in response time across individual blocks of time within the trial. It differs from HRTSD in that HRTSD measures variability across the entire trial. Minimum is 0. There are no absolute maximums. A higher score is WORSE.
Perseverations are errors made either faster than physiologically possible (<100ms). Minimum is 0, there is no maximum. Higher scores are WORSE."|Baseline vs end of open-label (week 8)|Note: One participant's CPT data was invalid||Units||Standard Deviation|Mean
645397|NCT02178995|Post-Hoc|QOLIE-89 Additional Subscales (Open-label)|"These are the remaining subscales of the QOLIE-89. These were not pre-specified variables of interest or intentional post-hoc analyses, but are automatically calculated in scoring the QOLIE-89 and are included ONLY for completeness of data submission.
QOLIE aggregate scores and subscale scores are calculated based on individual patient responses throughout the survey, and according to scoring rules as determined by the creator of the questionnaire. Scores are rated 0 (worst) to 100 (best)."|Visit 1 (baseline) vs end of open-label (week 8)|||Points||Standard Deviation|Mean
645398|NCT02178995|Other Pre-specified|Neuropsychiatric Questionnaires|"Beck Depression Inventory, Beck Anxiety Inventory, Apathy Evaluation Scale. These were not primary or secondary variables of interest given methylphenidate's primary expected action being on cognition. Included given one author's interest, as other studies suggesting psychiatric improvements (particularly apathy and depression) with methylphenidate.
BDI is a common clinical and research measure of depression. It has 21 questions and is scored 0 (no depression) to 63 (most severe depression). A higher score is worse.
BAI is a measure of anxiety, which also has 21 questions and is scored 0 (no anxiety) to 63 (most severe anxiety). A higher score is worse.
AES is a measure of clinical apathy, and is an 18-item scale. It rates symptoms as not at all, slightly, somewhat, or a lot, which are then converted to numerical values 1 (least apathy) to 4 (most apathy). Scores range from 18 (no apathy) to 72 (most apathy)."|Baseline (Visit 1) vs end of Open-label (week 8)|||Points||Standard Deviation|Mean
645399|NCT02178995|Other Pre-specified|Stimulant Side-effects Checklist|"This is a questionnaire covering common stimulant side-effects, intended to help monitor for any significant or common adverse effects.
The scale lists 16 common stimulant side effects rated 0 (absent) to 9 (serious). Minimum score is 0, maximum is 144. A higher score is WORSE."|Baseline (Visit 1) vs end of Open-label (week 8)|||Points||Standard Deviation|Mean
645400|NCT02178995|Other Pre-specified|Adverse Events Profile (Open-Label)|"This is a side-effects reporting scale for anti-epileptic medications. Because it encompasses cognitive and non-cognitive side effects, it was not considered one of our main cognitive/quality of life outcomes of interest. It is used in other studies of AED side effects, however, so was included.
The scale consists of 19 symptoms rated 1 (Never a problem) to 4 (Always or often a problem). Minimum score is 19, maximum score is 76. A higher score is WORSE."|Baseline (Visit 1) vs end of Open-label (week 8)|||Points||Standard Deviation|Mean
645401|NCT02178995|Secondary|CPT Outcomes (Secondary Variables) (Open-label Portion)|"Omissions, commissions, and hits
Hits” represents the raw number of accurate responses to target stimuli, out of a maximum of 288. A higher number is better.
Omissions” are errors committed when a target stimuli is not appropriately responded to. A higher number is worse. Theoretically, the maximum number of omissions would be 288. A lower number is BETTER.
Commissions” are errors committed when a participant responds to a non-target stimuli. Because a participant may make multiple such errors for a given stimuli, there is no raw maximum. A lower number is BETTER."|Baseline (Visit 1) vs end of Open-label (week 8)|Note: one epilepsy participant's CPT data was invalid/unusable due to pressing the wrong button during the trial.||Points||Standard Deviation|Mean
645402|NCT02178995|Secondary|QOLIE-89 Selected Cognitive Subscales (Open-label)|"Pre-selected secondary variables were cognitive subscales on the QOLIE-89 felt likely to be affected by MPH: attention/concentration; memory; language; energy/fatigue.
QOLIE aggregate scores and subscale scores are calculated based on individual patient responses throughout the survey, and according to scoring rules as determined by the creator of the questionnaire. Scores are rated 0 (worst) to 100 (best)."|Comparing baseline (visit 1) to end of open-label (end of week 8)|||Points||Standard Deviation|Mean
648287|NCT02107014|Primary|Change in IL-1α From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].|||pg/mL||95% Confidence Interval|Median
645403|NCT02178995|Secondary|Seizure Frequency/Severity (Double-blind Portion)|Seizures per 28 'at-risk' days. This is a comparison of 28 days prior to baseline visit as compared to seizure rate while taking methylphenidate, adjusted to provide a 'number of seizures per 28 days' measurement.|Seizure rate during 28 days prior to study compared to during randomized, single-dose portion, rate adjusted to seizures per 28 patient days.|Only participants who were present in both groups are included here.||Seizures per 28 at-risk days||Standard Deviation|Mean
645404|NCT02178995|Secondary|CPT Scores (Double-blind Portion) (Secondary Variables)|"Secondary variables in CPT: hits, omissions, commissions
Hits” represents the raw number of accurate responses to target stimuli, out of a maximum of 288. A higher number is better.
Omissions” are errors committed when a target stimuli is not appropriately responded to. A higher number is worse. Theoretically, the maximum number of omissions would be 288. A lower number is BETTER.
Commissions” are errors committed when a participant responds to a non-target stimuli. Because a participant may make multiple such errors for a given stimuli, there is no raw maximum. A lower number is BETTER."|Difference between scores on MPH 20mg, 10mg, or placebo during randomized visits weeks 2, 3, or 4|||Units||Standard Deviation|Mean
645405|NCT02178995|Primary|QOLIE-89 Aggregate Score|"QOLIE-89 is a questionnaire to assess quality of life and subjective cognitive effects. The aggregate score is the overall calculated score. Note: most of its questions are specific to patients with epilepsy, and therefore the questionnaire cannot be validly completed by healthy controls. Therefore, only participants with epilepsy completed the questionnaire.
QOLIE aggregate scores and subscale scores are calculated based on individual patient responses throughout the survey, and according to scoring rules as determined by the creator of the questionnaire. Scores are rated 0 (worst) to 100 (best)."|Change from baseline to end of methylphenidate open label treatment (end month 2)|||Points||Standard Deviation|Mean
645406|NCT02178995|Primary|Seizure Frequency (Open-label Portion)|Seizures per 28 'at-risk' days. This is a comparison of 28 days prior to baseline visit as compared to seizure rate while taking methylphenidate, adjusted to provide a 'number of seizures per 28 days' measurement.|Randomized portion is followed by 1-month open-label portion.|This analysis only compares the 28 participants who were present in both groups. Participants who participated only in the double-blind portion are represented in that analysis.||Seizures per 28 at-risk days||Standard Deviation|Mean
645407|NCT02178995|Primary|MCG (Open-label Portion)|MCG paragraph memory test is a measure verbal memory. Participants are read aloud a long, detailed story, and are then asked to immediately repeat all information they can remember from the story. Each pertinent story element (as pre-defined on a key) is considered 1 correct response. Minimum score is 0, maximum is 100. A higher score is better.|The single-dose double blind phase was followed by an open-label 4-week treatment phase.|||Points||Standard Deviation|Mean
645408|NCT02178995|Primary|Symbol-digit Matching Test (Open Label Phase)|Symbol-digit matching test is a measure processing speed and working memory. The task involves matching nonsense symbols with numbers based on a key as quickly as possible within 90s. Score represents the number of correct responses within the time frame. Minimum score is 0. There is not a meaningful 'maximum' score, as there are too many symbols for a participant to successfully complete within the allotted time. A higher score is better.|The single-dose double blind phase was followed by an open-label 4-week treatment phase.|||points||Standard Deviation|Mean
645409|NCT02178995|Primary|Conners CPT Outcomes (Primary Variables) (Open-Label Portion)|"Within-groups comparison (between visit 1 and visit 5 within patients with epilepsy, comparing scores at baseline to scores on methylphenidate) as well as a comparison against healthy controls who repeated the cognitive measures an equal number of times (to assess and control for test/retest and placebo improvements).
D' represents 'detectability,' and is a derived statistic which measures a participant's ability to distinguish target stimuli from non-target stimuli, and incorporates response time and accuracy factors. The equation for deriving it is proprietary to the test which markets the CPT. A higher, or less negative, score is considered WORSE.
HRTSD represents the standard deviation of participant hit reaction time data, as measured for a variety of different stimuli types across the trial. It is a measure of the participant's ability to maintain attention across the trial. A higher score represents more variability and is considered WORSE."|Difference between scores at baseline (visit 1) and on methylphenidate open-label (visit 5), compared to untreated healthy controls|PLEASE NOTE: One participant with epilepsy did not record any usable data for Conners CPT due to pressing the wrong key throughout large portions of the trial. Therefore, he is not included in CPT variables (but is included in other analyses).||Units||Standard Deviation|Mean
645410|NCT02178995|Primary|MCG Paragraph Memory Test (Double-blind Portion)|MCG paragraph memory test is a measure of verbal memory. Participants are read aloud a long, detailed story, and are then asked to immediately repeat all information they can remember from the story. Each pertinent story element (as pre-defined on a key) is considered 1 correct response. Minimum score is 0, maximum is 100. A higher score is better.|Difference in scores between MPH 20mg, 10mg, or placebo, randomized to be given at weeks 2, 3, or 4|||Points||Standard Deviation|Mean
645411|NCT02178995|Primary|Symbol-digit Matching Test (Double-blind Portion)|Symbol-digit matching test is a measure processing speed and working memory. The task involves matching nonsense symbols with numbers based on a key as quickly as possible within 90s. Score represents the number of correct responses within the time frame. Minimum score is 0. There is not a meaningful 'maximum' score, as there are too many symbols for a participant to successfully complete within the allotted time. A higher score is better.|Difference in scores between MPH 20mg, 10mg, or placebo during double-blind portion during which medication was randomized to weeks 2, 3, or 4.|||points||Standard Deviation|Mean
645412|NCT02178995|Primary|Conners' Continuous Performance Test (CPT) (Double-blind Portion, Primary Variables)|"Scores on this test measure attentiveness/vigilance and response time. Primary measures are: D', HRTSD D' represents 'detectability,' and is a derived statistic which measures a participant's ability to distinguish target stimuli from non-target stimuli, and incorporates response time and accuracy factors. The equation for deriving it is proprietary to the test which markets the CPT. A higher, or less negative, score is considered WORSE.
HRTSD represents the standard deviation of participant hit reaction time data, as measured for a variety of different stimuli types across the trial. It is a measure of the participant's ability to maintain attention across the trial. A higher score represents more variability and is considered WORSE."|difference in scores on specific variables between MPH 20mg, 10mg, and placebo (randomized to administration at weeks 2, 3, or 4)|||Units||Standard Deviation|Mean
645413|NCT02178787|Secondary|To Compare Profiles of UTlight Blood Flow (UT_BF) and Regional Oximetry (UT_Ox).|CO2 reactivity will be measured as the slope of regression between UT_BF or UT_Ox and CO2 changes during baseline, hyperventilation, and CO2 re-breathing.|one year|The data analysis has determined that UT_BF and UT_OX signals were not reliable and required further algorithm modification and development during post processing (e.g. raw data signal to noise, signal averaging) that are beyond the scope of the study. Therefore, the results were inconsistent and inconclusive. No results to report.|||||
645414|NCT02178787|Primary|To Compare Profiles of TCD-blood Flow Velocities (TCD_BFV).|CO2 reactivity will be measured as the slope of regression between TCD_BFV and CO2 changes during baseline, hyperventilation, and CO2 re-breathing.|one year|||cm/sec||Standard Error|Mean
645415|NCT02178540|Primary|The Use of the Approved US TOBI Podhaler Instructions for Use (IFU) to Communicates the Information Necessary to Achieve Safe and Effective Use of the Podhaler Device|Recording all use errors and close calls associated with inhalation of one dose of TOBI Podhaler (i.e., inhaling the contents of four placebo capsules via the Podhaler device) by subjects (CF patients, and caregivers, if applicable). The study population consisted of CF patients (and caregivers) naïve to the Podhaler device and untrained in the use of the device. Assessing the root cause of use errors and close calls for 6 defined critical errors (agreed with the FDA) and establishing those which can be attributed to a lack of clarity or presence of ambiguities in the IFU content, i.e., errors attributable to a failure to understand the IFU.|1 Day|The Full Analysis Set (FAS) included all enrolled patients who completed an HF assessment as defined by completion of inhalation of the contents of at least one capsule and related HF assessment.||Patients failing to understand IFU|||Number
645416|NCT02178059|Primary|Maximum Observed Plasma Concentration (Cmax)|These will be taken at each treatment period|Samples will be taken at predose, and at 5, 10, 20, 40, 80, 100 minutes and at 2, 4, 6, 9, 12, 18, 24, 30, and 36 hours postdose|The PK analysis set included all healthy subjects who received at least 1 dose of the IMP and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the IMP.||nmol/L||95% Confidence Interval|Geometric Mean
645417|NCT02178059|Secondary|Terminal Half-life (t1/2)|These will be taken at each treatment period|Samples will be taken at predose, and at 5, 10, 20, 40, 80, 100 minutes and at 2, 4, 6, 9, 12, 18, 24, 30, and 36 hours postdose|||hour||Geometric Coefficient of Variation|Geometric Mean
645418|NCT02178059|Secondary|Area Under the Plasma Concentration-time Curve From Zero to 36 Hours Postdose [AUC(0-36)]|These will be taken at each treatment period|Samples will be taken at predose, and at 5, 10, 20, 40, 80, 100 minutes and at 2, 4, 6, 9, 12, 18, 24, 30, and 36 hours postdose|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
645419|NCT02178059|Secondary|Area Under the Plasma Concentration-time Curve From Zero Extrapolated to Infinity (AUC)|These will be taken at each treatment period|Samples will be taken at predose, and at 5, 10, 20, 40, 80, 100 minutes and at 2, 4, 6, 9, 12, 18, 24, 30, and 36 hours postdose|||nmol*h/L||95% Confidence Interval|Geometric Mean
645420|NCT02178059|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)|These will be taken at each treatment period|Samples will be taken at predose, and at 5, 10, 20, 40, 80, 100 minutes and at 2, 4, 6, 9, 12, 18, 24, 30, and 36 hours postdose|||hour||95% Confidence Interval|Median
645421|NCT02178059|Primary|Area Under the Plasma Concentration-time Curve From Zero to the Time of Last Measurable Concentration [AUC(0-t)]|These will be taken at each treatment period|Samples will be taken at predose, and at 5, 10, 20, 40, 80, 100 minutes and at 2, 4, 6, 9, 12, 18, 24, 30, and 36 hours postdose|The PK analysis set included all healthy subjects who received at least 1 dose of the IMP and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the IMP.||nmol*h/L||95% Confidence Interval|Geometric Mean
645422|NCT02177266|Other Pre-specified|Number of Participants With Serious and Non-Serious Adverse Events||Baseline - 3 months|The data were not analyzed because the 2 subjects enrolled withdrew before completing the study; the study was terminated early due to the difficulty in enrolling subjects.|||||
645423|NCT02177266|Secondary|Trans-thoracic Echocardiography for Constriction||Baseline to 3 months|The data were not analyzed because the 2 subjects enrolled withdrew before completing the study; the study was terminated early due to the difficulty in enrolling subjects.|||||
645424|NCT02177266|Primary|Number of Patients With Post Cardiac Surgery Atrial Fibrillation or Post-pericardiotomy Syndrome.||Baseline to 3 months|The data were not analyzed because the 2 subjects enrolled withdrew before completing the study; the study was terminated early due to the difficulty in enrolling subjects.|||||
645425|NCT02177201|Primary|Postoperative Vomiting|Presence of at least one episode of vomiting within the first 24 hours of postoperative is positive for definition|First 24 hours postoperative|||participants|||Number
645426|NCT02177032|Secondary|Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Adult Subjects, ≥ 18 Years of Age|Immunogenicity was assessed in terms of the number of subjects With Anti-RVNA concentration ≥0.5 IU/mL at Days 8, 15, 50, 91, 181 and 366 in Adult Subjects, ≥ 18 Years of Age|At Days 8, 15,50, 91, 181 and 366|Per Protocol Set (PPS): all subjects who correctly receive the vaccine doses, provided immunogenicity data at the relevant time points and were not excluded due to reasons defined prior to the analysis. This outcome measure is applicable only for 4-sites, 1-week with HRIG and 2-sites, TRC with HRIG Groups||Percentages of Subjects||95% Confidence Interval|Number
645427|NCT02177032|Secondary|Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration ≥0.5 IU/mL and Vaccine Group Differences in Adult Subjects, ≥ 18 Years of Age|Immunogenicity was assessed in terms of the Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration ≥0.5 IU/mL at Days 8, 15, 50,91, 181 and 366 in Adult Subjects, ≥ 18 Years of Age|At Days 8, 15, 50, 91, 181 and 366|Per Protocol Set (PPS): all subjects who correctly receive the vaccine doses, provided immunogenicity data at the relevant time points and were not excluded due to reasons defined prior to the analysis. This outcome measure is applicable only for 4-sites, 1-week with HRIG and 2-sites TRC with HRIG Groups.||IU/mL||95% Confidence Interval|Geometric Mean
645428|NCT02177032|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Safety was assessed in terms of the Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Day 1 to Day 366|Unsolicited Safety Set- All subjects in the Exposed Population who have post vaccination unsolicited adverse event records. The number of exposed set participants analyzed for safety is different from the Per Protocol Set (PPS) for immunogenicity.||Subjects|||Number
645429|NCT02177032|Secondary|Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination|Number of subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination|From day 1 to day 3; from day 4 to day 7; from day 8 to day 14; from day 29 to day 35(2-sites, TRC PEP, ID regimen)|Solicited Safety Set- All subjects in the Exposed Population who provide post vaccination solicited adverse event data. The number of exposed set participants analyzed for safety is different from the Per Protocol Set (PPS) for immunogenicity.||Subjects|||Number
645430|NCT02177032|Secondary|Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Children and Adult Subjects, ≥ 1 Years of Age|Immunogenicity was assessed in terms of the Percentages of Subjects With Anti-RVNA concentration ≥0.5 IU/mL at Days 8, 15, 50, 91, 181 and 366 in Children and Adult Subjects, ≥ 1 Years of Age|At Days 8, 15, 50, 91, 181 and 366|Per Protocol Set (PPS): all subjects who correctly receive the vaccine doses, provided immunogenicity data at the relevant time points and were not excluded due to reasons defined prior to the analysis. This outcome measure is only applicable for the 4-sites, 1-week without HRIG and 2-sites, TRC without HRIG Groups.||Percentages of Subjects||95% Confidence Interval|Number
645431|NCT02177032|Secondary|Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration in Children and Adult Subjects, ≥ 1 Years of Age|Immunogenicity was assessed in terms of the Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration at Days 8, 15, 50, 91, 181 and 366 in Children and Adult Subjects, ≥ 1 Years of Age|At Days 8, 15, 50, 91, 181 and 366|Per Protocol Set (PPS): all subjects who correctly receive the vaccine doses, provided immunogenicity data at the relevant time points and were not excluded due to reasons defined prior to the analysis. This outcome measure is applicable only for the 4-sites, 1-week without HRIG and 2-sites, TRC without HRIG Groups.||IU/mL||95% Confidence Interval|Geometric Mean
645432|NCT02177032|Secondary|Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Adult Subjects, ≥ 18 Years of Age|"Immunogenicity was assessed in terms of the Percentages of Subjects With Anti-RVNA concentration ≥0.5 IU/mL at Days 8, 15, 50, 91, 181 and 366 in Adult Subjects, ≥ 18 Years of Age.
Percentage of subjects with RVNA titer ≥ 0.5 IU/mL at days 8, 15, 50, 91, 181 and 366 and group differences (4-sites,1-week without HRIG versus 4-sites,1-week with HRIG; 4-sites,1-week with HRIG versus 2-sites,TRC with HRIG; 4-sites,1-week without HRIG versus 2-sites, TRC without HRIG)"|At Days 8, 15,50, 91, 181 and 366|Per Protocol Set (PPS): all subjects who correctly receive the vaccine doses, provided immunogenicity data at the relevant time points and were not excluded due to reasons defined prior to the analysis. This outcome measure is applicable only for the 4-sites, 1-week with HRIG and 4-sites, 1-week without HRIG Groups.||Percentages of Subjects||95% Confidence Interval|Number
645433|NCT02177032|Secondary|Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration and Vaccine Group Differences in Adult Subjects, ≥ 18 Years of Age|"Immunogenicity was assessed in terms of the Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration at Days 8, 15, 50,91, 181 and 366 in Adult Subjects, ≥ 18 Years of Age.
RVNA GMCs with RVNA titer ≥ 0.5 IU/mL at days 8, 15, 50, 91, 181 and 366 and group differences (4-sites,1-week without HRIG versus 4-sites,1-week with HRIG; 4-sites,1-week with HRIG versus 2-sites,TRC with HRIG; 4-sites,1-week without HRIG versus 2-sites, TRC without HRIG)"|At Days 8, 15, 50, 91, 181 and 366|Per Protocol Set (PPS): all subjects who correctly receive the vaccine doses, provided immunogenicity data at the relevant time points and were not excluded due to reasons defined prior to the analysis. This outcome measure is applicable only for the 4-sites, 1-week with HRIG and 4-sites, 1-week without HRIG Groups.||IU/mL||95% Confidence Interval|Geometric Mean
645434|NCT02177032|Secondary|Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL at Days 8, 15, 91, 181 and 366 in Children and Adult Subjects and Vaccine Group Differences (2 ID Rabies Vaccine Regimens (4-sites, 1-week and 2-sites, TRC), With or Without HRIG), ≥ 1 Years of Age|"Vaccine group differences are calculated assuming a binomial distribution and the associated confidence interval for the differences in percentage was based on M-N method.
RVNA percentage of subjects with RVNA titer ≥ 0.5 IU/mL at study days 8, 15, 91, 181, and 366 following administration of the 2 ID rabies vaccine regimens (4-sites, 1-week and 2-sites, TRC), with or without HRIG, in the whole study population."|At Days 8, 15, 91, 181 and 366|Per Protocol Set (PPS): all subjects who correctly receive the vaccine doses, provided immunogenicity data at the relevant time points and were not excluded due to reasons defined prior to the analysis.||Percentages of Subjects||95% Confidence Interval|Number
645435|NCT02177032|Secondary|Geometric Mean Rabies Virus Neutralizing Antibody Concentration at Days 8, 15, 91, 181 and 366 & Between-group (2 ID Rabies Vaccine Regimens (4-sites,1-week & 2-sites, TRC) With or Without HRIG) Ratio of GMCs in Children & Adult Subjects,≥ 1 Years of Age|"Immunogenicity was assessed in terms of the Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration at Days 8, 15, 91, 181 and 366 in Children and Adult Subjects, ≥ 1 Years of Age The GMCs, GMRs (i.e., within group ratio) and associated two sided 95% confidence intervals for each group were computed by exponentiating (base 10) of the least square means of the logarithmically transformed (base 10) concentration (and their differences) and the 95% CIs obtained from an Analysis of variance (ANOVA) with vaccine regimen, age strata and center as factors.
Non-inferiority of the immune response between the 2 ID rabies vaccine regimens (4-sites, 1-week and 2-sites, TRC) with or without HRIG administration as measured by RVNA GMCs at day 50 in the whole study population."|At Days 8, 15, 91, 181 and 366|Per Protocol Set (PPS): all subjects who correctly receive the vaccine doses, provided immunogenicity data at the relevant time points and were not excluded due to reasons defined prior to the analysis.||IU/mL||95% Confidence Interval|Geometric Mean
645436|NCT02177032|Secondary|Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration and Between-group (2 ID Rabies Vaccine Regimens (4-sites, 1-week and 2-sites, TRC) With or Without HRIG) Ratio of GMCs|"Immunogenicity was assessed in terms of Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration in Children and Adult Subjects, ≥ 1 Years of Age at day 50 The GMCs, GMRs (i.e., within group ratio) and associated two sided 95% confidence intervals for each group were computed by exponentiating (base 10) of the least square means of the logarithmically transformed (base 10) concentration (and their differences) and the 95% CIs obtained from an Analysis of variance (ANOVA) with vaccine regimen, age strata and center as factors.
Non-inferiority of the immune response between the 2 ID rabies vaccine regimens (4-sites, 1-week and 2-sites, TRC) with or without HRIG administration as measured by RVNA GMCs at day 50 in the whole study population."|Study Day 50|Per Protocol Set (PPS): all subjects who correctly receive the vaccine doses, provided immunogenicity data at the relevant time points and were not excluded due to reasons defined prior to the analysis||IU/mL||95% Confidence Interval|Geometric Mean
645437|NCT02177032|Primary|"Percentages of Subjects With RVNA Titer >= 0.5 and Vaccine Group Differences (4-sites, 1-week to That of 2-sites, TRC ID PEP Regimen of the PCEC Rabies Vaccine With or Without HRIG Administration)"|"Vaccine group differences are calculated assuming a binomial distribution and the associated confidence interval for the differences in percentage was based on M-N method.
Non-inferiority of the immune response of the new 4-sites, 1-week ID PEP regimen of the PCEC vaccine, with or without HRIG administration, to that of the currently recommended 2-sites, TRC ID PEP regimen of the PCEC rabies vaccine with or without HRIG administration, as measured by the percentage of subjects with RVNA titer ≥ 0.5 IU/ml at day 50 in the whole study population."|Study day 50 (D50)|Per Protocol Set (PPS): all subjects who correctly receive the vaccine doses, provided immunogenicity data at the relevant time points and were not excluded due to reasons defined prior to the analysis.||Percentages of Subjects||95% Confidence Interval|Number
645438|NCT02176655|Other Pre-specified|Meaningful Headache Relief|Time to meaningful headache relief for VVD-101 vs. placebo. Meaningful headache relief is defined as experiencing substantial relief as reported by the subject.|Time of Onset to Meaningful Headache Relief (up to 24 hours)|Given the design of the study, all subjects treated headaches 1-6 in a randomized fashion with either VVD-101 or placebo, therefore the same 25 subjects are in the VVD-101 and Placebo analysis population. A total of 25 subjects were analyzed for this endpoint.||minutes||Standard Deviation|Mean
645439|NCT02176655|Other Pre-specified|Comparing Acute Hangover Scale Individual Symptoms With Headache Severity 2 Hours Post Treatment|Comparison of headache severity 2 hours post treatment of headache treated with VVD-101 with each associated hangover symptom items on the AHS taken before treatment. Individual Hangover Symptoms Scores range from 0 [None] to 7 [Incapacitating]. The AHS scale is rated on a score of 0-63. A score of 0 indicates no symptoms and a total score of 63 indicates the maximum number of reported symptoms.Headache severity was measured on a 4 point Likert scale with 0 = no pain, 1 = mild pain, 2 = moderate, 3 = severe pain.|Immediately Before Treatment to 2 Hours Post Treatment|Given the design of the study, all subjects treated headaches 1-6 in a randomized fashion with either VVD-101 or placebo, therefore the same 25 subjects are in the VVD-101 and Placebo analysis population. A total of 25 subjects were analyzed for this endpoint.||units on a scale||Standard Deviation|Mean
645440|NCT02176655|Other Pre-specified|Number of Drinks Consumed Compared to Pain Severity 2 Hours Post Treatment|Comparison of the number of drinks consumed at one sitting with pain severity 2 hours post treatment for headaches treated with VVD-101. Headache severity was measured on a 4 point Likert scale with 0 = no pain, 1 = mild pain, 2 = moderate, 3 = severe pain.|Time of Last Sitting to 2 Hours Post Treatment (estimated 14 hours)|Given the design of the study, all subjects treated headaches 1-6 in a randomized fashion with either VVD-101 or placebo, therefore the same 25 subjects are in the VVD-101 and Placebo analysis population. A total of 25 subjects were analyzed for this endpoint.||Number of Drinks Consumed||Standard Deviation|Mean
645441|NCT02176655|Secondary|Acute Hangover Scale Compared to Pain Severity 2 Hours Post Treatment|Comparison of Acute Hangover Scale (AHS) score before treatment with headache pain severity 2 hours post treatment for headaches treated with VVD-101. The AHS scale is rated on a score of 0-63. A score of 0 indicates no symptoms and a total score of 63 indicates the maximum number of reported symptoms. Headache severity was measured on a 4 point Likert scale with 0 = no pain, 1 = mild pain, 2 = moderate, 3 = severe pain.|Immediately Before Treatment of 3 Headaches to 2 Hours Post Treatment|Given the design of the study, all subjects treated headaches 1-6 in a randomized fashion with either VVD-101 or placebo, therefore the same 25 subjects are in the VVD-101 and Placebo analysis population. A total of 25 subjects were analyzed for this endpoint.||units on a scale||Standard Deviation|Mean
645442|NCT02176655|Secondary|Satisfaction|To assess subject satisfaction with treatment results comparing VVD-101 vs. placebo. Satisfaction was measured on a 7 point Likert scale whereas 0 = extremely dissatisfied and 6 = extremely satisfied.|24 Hours Post Treatment for 3 Headaches (estimated 6 months)|Given the design of the study, all subjects treated headaches 1-6 in a randomized fashion with either VVD-101 or placebo, therefore the same 25 subjects are in the VVD-101 and Placebo analysis population. A total of 25 subjects were analyzed for this endpoint.||units on a scale||Standard Deviation|Mean
645443|NCT02176655|Secondary|Number of Participants With Consistent Response to VVD-101|To assess the consistency of response to VVD-101 over the three active treatments of VVD-101. Consistency is defined as meeting the requirements of headache relief 2 hours post treatment for 2 out of 3 active treated headaches. Headache relief is defined as a headache going from moderate or severe to mild or no headache or mild headache going to no headache. Headache severity was measured on a 4 point Likert scale with 0 = no pain, 1 = mild pain, 2 = moderate, 3 = severe pain.|Response to Treatment of Three Headaches (estimated 6 months)|Given the design of the study, all subjects treated headaches 1-6 in a randomized fashion with either VVD-101 or placebo, therefore the same 25 subjects are in the VVD-101 and Placebo analysis population. A total of 25 subjects were analyzed for this endpoint.||participants|||Number
645444|NCT02176655|Secondary|Number of Headaches With Sustained Pain Freedom at Twenty Four Hours Post Treatment|Number of headaches with sustained headache pain freedom at 24 hours post treatment for VVD-101 vs. placebo. Sustained headache pain freedom is defined as no pain 2 hours post treatment and headache freedom continuing for 24 hours post treatment without rescue. Headache severity was measured on a 4 point Likert scale with 0 = no pain, 1 = mild pain, 2 = moderate, 3 = severe pain.|Time of Treatment to 24 Hours Post Treatment|Given the design of the study, all subjects treated headaches 1-6 in a randomized fashion with either VVD-101 or placebo, therefore the same 25 subjects are in the VVD-101 and Placebo analysis population. A total of 25 subjects, with 28 headaches were analyzed for this endpoint.||Headaches|Headaches||Number
645445|NCT02176655|Secondary|Number of Headaches Relieved to Complete Pain Freedom at Two Hours Post Treatment|Number of headaches relieved (no head pain) at 2 hours post treatment for VVD-101 vs. placebo. Headache severity was measured on a 4 point Likert scale with 0 = no pain, 1 = mild pain, 2 = moderate, 3 = severe pain.|Immediately Prior to Treatment to 2 Hours Post Treatment|Given the design of the study, all subjects treated headaches 1-6 in a randomized fashion with either VVD-101 or placebo, therefore the same 25 subjects are in the VVD-101 and Placebo analysis population. A total of 25 subjects, with 87 headaches were analyzed for this endpoint.||Headaches|Headaches||Number
645594|NCT02171611|Secondary|t1/2 for Total Dabigatran|Terminal half-life of the analyte in plasma (t1/2) for total dabigatran|-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.|pharmacokinetic per-protocol set||hour||Geometric Coefficient of Variation|Geometric Mean
645446|NCT02176655|Secondary|Number of Headaches Relieved|Headache relief from before treatment, at 30 minutes, 1 hour, and 2 hours post treatment in attacks treated with VVD-101 vs. placebo. Headache relief is defined as a headache going from moderate or severe to mild or no headache or mild headache going to no headache. Headache severity was measured on a 4 point Likert scale with 0 = no pain, 1 = mild pain, 2 = moderate, 3 = severe pain.|Immediately Prior to Treatment to 2 Hours Post Treatment|Given the design of the study, all subjects treated headaches 1-6 in a randomized fashion with either VVD-101 or placebo, therefore the same 25 subjects are in the VVD-101 and Placebo analysis population. A total of 25 subjects, with 87 headaches were analyzed for this endpoint.||Headaches|Headaches||Number
645447|NCT02176655|Secondary|Headache Severity at Treatment, 30 Minutes and 1 Hour Post Treatment|Change in headache severity from before treatment, at 30 minutes, and 1 hour post treatment in attacks treated with VVD-101 vs. placebo. Headache severity was measured on a 4 point Likert scale with 0 = no pain, 1 = mild pain, 2 = moderate, 3 = severe pain.|Immediately Prior to Treatment through 1 Hours Post Treatment|Given the design of the study, all subjects treated headaches 1-6 in a randomized fashion with either VVD-101 or placebo, therefore the same 25 subjects are in the VVD-101 and Placebo analysis population. A total of 25 subjects were analyzed for this endpoint.||units on a scale||Standard Deviation|Mean
645448|NCT02176655|Primary|Headache Severity 2 Hours Post Treatment|Headache severity 2 hours post treatment in sumatriptan succinate 12.5 mg and acetylsalicylic acid 325 mg (VVD-101) vs. placebo. Headache severity was measured on a 4 point Likert scale with 0 = no pain, 1 = mild pain, 2 = moderate, 3 = severe pain.|Immediately Prior to Treatment through 2 Hours Post Treatment|Given the design of the study, all subjects treated headaches 1-6 in a randomized fashion with either VVD-101 or placebo, therefore the same 25 subjects are in the VVD-101 and Placebo analysis population. A total of 25 subjects were analyzed for this endpoint.||units on a scale||Standard Deviation|Mean
645449|NCT02176525|Secondary|Body Temperature|The body temperature will be presented as the mean values in visit 1 and visit 7. The number of participants analysed displays the number of participants included in the analysis set whereas the numbers for each timepoint display the number of participants with available data at that timepoint.|Visit 1, Visit 7|Treated set.||degree (°C)||Standard Deviation|Mean
645450|NCT02176525|Secondary|Assessment of Global Tolerability on a 4-point Scale|The global tolerability was presented on a four item scale: good, satisfactory, not satisfactory and bad. Rating was done by the investigator.|day 6|The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment, regardless of randomisation.||participants|||Number
645451|NCT02176525|Secondary|Number of Patients With Abnormal Findings in Physical Examination|The number of patients with abnormal findings in physical examination presents the number of patients with any treatment-emergent adverse events in this study.|up to day 14|The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment, regardless of randomisation.||participants|||Number
645452|NCT02176525|Secondary|Number of Patients With Adverse Events|Number of patients with any adverse event (AE)|up to 14 days|The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment, regardless of randomisation.||participants|||Number
645453|NCT02176525|Secondary|Number of Patients With Abnormal Changes in Laboratory Tests|Number of patients with abnormal changes in safety laboratory tests including urine protein diagnostics, and adrenocorticotropic hormone (ACTH) and cortisol measurements resulted in adverse events.|Baseline, up to day 14|The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment, regardless of randomisation.||participants|||Number
645454|NCT02176525|Secondary|Number of Patients With Abnormal Findings in 12-lead ECG (Electrocardiogram)|Number of patients with a new onset of an abnormal finding by central assessment are presented.|up to 14 days|Treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment, regardless of randomisation. Only patients included having no missing ECG measurements .||participants|||Number
645455|NCT02176525|Secondary|Number of Patients With Clinically Significant Changes in Vital Signs (Pulse Rate, Systolic and Diastolic Blood Pressure).|Number of patients with clinically significant changes in vital signs (pulse rate, systolic and diastolic blood pressure) presents the number of patients with an reported adverse event which has a symptom in changes in vital signs. Vascular disorders was identified as changes in vital signs. The number of participant with vascular disorders is presented in this outcome measure|Baseline, up to day 14|The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment, regardless of randomisation.||participants|||Number
645456|NCT02176525|Secondary|Plasma Concentration Time Profiles|Individual drug plasma concentrations of Deleobuvir after multiple oral administration. Within the categories PTM means planned time. The number of participants analysed displays the number of participants included in the analysis data set whereas the number of participants for each timepoint displays the number of participants with available data at that timepoint. Below the limit of quantification (BLQ) is abbreviated.|up to day 7|The full analysis set (FAS) included all randomised patients who were dispensed study medication and were documented to have taken at least one dose of study medication.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
645457|NCT02176525|Secondary|Vz/F,ss|"Apparent volume of Deleobuvir distribution during the terminal phase λz following an oral dose at steady state (Vz/F,ss) after the last dose of study drug.
more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h (*At these time points, in patients with cirrhosis only). The number of participants analysed displays the number of participants with available data at the timepoints of interest."|5 min prior to the first dose of study medication of Day 5; 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00, 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h thereafter|PKS||Litre (L)||Geometric Coefficient of Variation|Geometric Mean
648153|NCT02108171|Other Pre-specified|Duration of Anesthesia of Patients Receiving Intranasal Placebo|Duration of anesthesia of patients receiving intranasal placebo Duration from anesthesia intubation to anesthesia ending|1 day|||minutes|||Number
645458|NCT02176525|Secondary|CL/F,ss|"Apparent clearance of Deleobuvir in plasma after oral administration at steady state (CL/F,ss) measured after the last dose of study drug.
more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h (*At these time points, in patients with cirrhosis only). The number of participants analysed displays the number of participants with available data at the timepoints of interest."|5 min prior to the first dose of study medication of Day 5; 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00, 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h thereafter|PKS||Millilitre per minute (mL/min)||Geometric Coefficient of Variation|Geometric Mean
645459|NCT02176525|Secondary|t1/2,ss|"Terminal half-life of Deleobuvir in plasma at steady state (t1/2,ss) measured after the last dose of study drug.
more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h (*At these time points, in patients with cirrhosis only). The number of participants analysed displays the number of participants with available data at the timepoints of interest."|5 min prior to the first dose of study medication of Day 5; 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00, 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h thereafter|PKS||h||Full Range|Median
645460|NCT02176525|Secondary|λz,ss|"Terminal rate of Deleobuvir constant in plasma at steady state (λz,ss) measured after last dose of study drug.
more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h (*At these time points, in patients with cirrhosis only). The number of participants analysed displays the number of participants with available data at the timepoints of interest."|5 min prior to the first dose of study medication of Day 5; 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00, 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h thereafter|PKS||1/h||Full Range|Median
645461|NCT02176525|Secondary|AUC0-∞,ss|"Area under the concentration-time curve of Deleobuvir in plasma over the interval 0 hour (h) extrapolated to infinity at steady state (AUC0-∞,ss) measured after last administration of trial drug.
more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h (*At these time points, in patients with cirrhosis only). The number of participants analysed displays the number of participants with available data at the timepoints of interest."|5 min prior to the first dose of study medication of Day 5; 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00, 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h thereafter|PKS||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
645462|NCT02176525|Secondary|AUCτ,ss|"Area under the concentration-time curve of Deleobuvir in plasma at steady state over a uniform dosing interval τ (AUCτ,ss) measured after last dose of trial drug.
more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h (*At these time points, in patients with cirrhosis only). The number of participants analysed displays the number of participants with available data at the timepoints of interest."|5 min prior to the first dose of study medication of Day 5; 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00, 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h thereafter|PKS||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
645463|NCT02176525|Secondary|Tmax,ss|Time from dosing to the maximum measured concentration of Deleobuvir at steady state after the last dose of study drug (tmax,ss) more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h (*At these time points, in patients with cirrhosis only)|5 min prior to the first dose of study medication of Day 5; 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00, 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h thereafter|PKS||h||Full Range|Median
645464|NCT02176525|Secondary|Cmin,ss|"The minimum measured concentration of Deleobuvir in plasma at steady state (Cmin,ss).
more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h (*At these time points, in patients with cirrhosis only). The number of participants analysed displays the number of participants with available data at the timepoints of interest."|5 min prior to the first dose of study medication of Day 5; 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00, 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h thereafter|PKS||ng/mL||Geometric Coefficient of Variation|Geometric Mean
645465|NCT02176525|Secondary|Cmax,ss|"The maximum measured concentration of Deleobuvir in plasma at steady state after the last dose of study drug (Cmax,ss).
more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h (*At these time points, in patients with cirrhosis only)"|5 min prior to the first dose of study medication of Day 5; 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00, 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h thereafter|PKS||ng/mL||Geometric Coefficient of Variation|Geometric Mean
645466|NCT02176525|Secondary|AUC0-τ|Area under the concentration-time curve of Deleobuvir in plasma over the interval 0 hour (h) to the next dose of trial medication (AUC0-τ) measured after first administration of trial drug.|5 minutes (min) prior to the first dose of study medication and 30 minutes and 1:00, 2:00, 3:00, 4:00, 6:00, 7:55, 10:00, 12:00, 15:55, 18:00 hours (h) thereafter on day 1|PKS||Nanogram*hours/millilitre (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
645467|NCT02176525|Secondary|Tmax|Time from dosing to maximum measured concentration (tmax) of Deleobuvir determined after the first dose.|5 minutes (min) prior to the first dose of study medication and 30 minutes and 1:00, 2:00, 3:00, 4:00, 6:00, 7:55, 10:00, 12:00, 15:55, 18:00 hours (h) thereafter on day 1|PKS||hours (h)||Full Range|Median
645468|NCT02176525|Secondary|Cmin|Measured concentration of Deleobuvir in plasma determined immediately before the second dose (Cmin). The number of participants analysed displays the number of participants with available data at the timepoints of interest.|5 minutes (min) prior to the first dose of study medication and 30 minutes and 1:00, 2:00, 3:00, 4:00, 6:00, 7:55, 10:00, 12:00, 15:55, 18:00 hours (h) thereafter on day 1|PKS||ng/mL||Geometric Coefficient of Variation|Geometric Mean
645469|NCT02176525|Secondary|Cmax|Maximum measured concentration of Deleobuvir in plasma (Cmax) determined after the first dose.|5 minutes (min) prior to the first dose of study medication and 30 minutes and 1:00, 2:00, 3:00, 4:00, 6:00, 7:55, 10:00, 12:00, 15:55, 18:00 hours (h) thereafter on day 1|The PK set (PKS) included all patients in the full analysis set (FAS) with evaluable PK data. FAS included all randomised patients who were dispensed study medication and were documented to have taken at least one dose of study medication.||nanogram/millilitre (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
645470|NCT02176525|Secondary|Time Dependent Change From Baseline in Viral Load (VL)|Change of VL from baseline to day 7 is presented (VL at timepoint minus VL at baseline). Acronym used within the categories: planned time (PTM). The number of participants analysed displays the number of participants included in the analysis set whereas the number of participants for each timepoint display the number of participants with available data at that timepoint.|Baseline, up to day 7|The full analysis set (FAS) included all randomised patients who were dispensed study medication and were documented to have taken at least one dose of study medication.||log10 (U/L)||Standard Deviation|Mean
645471|NCT02176525|Primary|Virologic Response (VR)|Virologic response was defined as a ≥ 1 log10 reduction in serum Hepatitis C virus (HCV) Ribonucleic acid (RNA) level from baseline at any time from the start of administration of treatment up to day 5. In this Outcome Measure the percentage of participants with virologic response is presented.|Baseline (Visit 2_2 at planned time 5 minutes prior to first administration of trial drug), up to day 5|The full analysis set (FAS) included all randomised patients who were dispensed study medication and were documented to have taken at least one dose of study medication.||percentage of participants||95% Confidence Interval|Number
645472|NCT02176421|Secondary|Subject Overall Eye Appearance Total Score on the 5-Point Periorbital Aesthetic Appearance Questionnaire (PAAQ)|Subjects assessed their overall eye appearance on the PAAQ. The PAAQ includes 9 questions about how the subject’s overall eye appearance affected them over the past 7 days. Each question is assessed on a 5-point scale from 0 (never/best) to 4 (all of the time/worse), with the total score ranging from 0 (best) to 36 (worse).|Day 0, Day 14, Month 1, Month 6, Month 9, Month 12|All subjects with data for this outcome measure||Scores on a Scale||Standard Deviation|Mean
645473|NCT02176421|Secondary|Percentage of Subjects Assessed by the Subjects as Very Well Improved or Well Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS)|The subjects evaluated their global aesthetic improvement on the right and left sides using the 5-point GAIS (1=Very Well Improved, 2=Well Improved, 3=Improved, 4=Not Improved, 5=Worsened State). The percentage of subjects assessed as Very Well Improved and Well Improved are reported.|Day 0, Day 14, Month 1, Month 6, Month 9, Month 12|All subjects with data for this outcome measure||Percentage of Subjects|||Number
645474|NCT02176421|Secondary|Percentage of Subjects Assessed by the Investigator as Very Well Improved or Well Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS)|The Investigator evaluated the subjects global aesthetic improvement on right and left sides using the 5-point GAIS (1=Very Well Improved, 2=Well Improved, 3=Improved, 4=Not Improved, 5=Worsened State). The percentage of subjects assessed as Very Well Improved and Well Improved are reported.|Day 0, Day 14, Month 1, Month 6, Month 9, Month 12|All subjects with data for this outcome measure||Percentage of Subjects|||Number
645475|NCT02176421|Secondary|Injector Ease of Use on an 11-Point Scale|The injectors rated the ease of injection and ease of modeling of the product on an 11-point scale from 0 (extremely difficult) to 10 (extremely easy).|Day 0|All subjects with data for this outcome measure||Scores on a Scale||Standard Deviation|Mean
645476|NCT02176421|Secondary|Percentage of Subjects With a ≥1 Grade Improvement From Baseline in Infra-Orbital Area on the AIRS on the Right and Left Side|The Investigator evaluated the severity of skin crease and volume loss in the infra-orbital area on both the right and left sides on the 6-point AIRS ranging from 0 (least severe) to 5 (most severe).|Baseline, Day 0, Day 14, Month 6, Momth 9, Month 12|All subjects with data for this outcome measure||Percentage of Subjects|||Number
645477|NCT02176421|Primary|Percentage of Subjects With a ≥1 Grade Improvement From Baseline in Infra-Orbital Area on the Allergan Infra-Orbital Rating Scale (AIRS) on the Right and Left Side|The Investigator evaluated the severity of skin crease and volume loss in the infra-orbital area on both the right and left sides on the 6-point AIRS ranging from 0 (least severe) to 5 (most severe).|Baseline, Month 1|All subjects with data for this outcome measure||Percentage of Subjects|||Number
645478|NCT02176356|Secondary|Change From Baseline in the Participant Satisfaction With Appearance of Periorbital Area|Participants assessed how their overall eye appearance has affected them over the past 7 days using the 9-item Periorbital Aesthetic Appearance Questionnaire (PAAQ). Possible responses to each question were: 0=Never (best), 1=Rarely, 2=Some of the time, 3=Most of the time and 4=All of the time with a total possible score of 0 to 36. A negative change from Baseline indicates improvement.|Baseline, Month 4|Participants from the mITT population, all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment, with data available for analysis.||score on a scale||Standard Deviation|Mean
645595|NCT02171611|Secondary|λz for Free Dabigatran||-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.|pharmacokinetic per-protocol set||1/hour||Geometric Coefficient of Variation|Geometric Mean
645479|NCT02176356|Secondary|Change From Baseline in the Investigator’s Assessment of the Participant's Perioral Lines Severity|The investigator assessed the participant’s perioral lines severity using the 4-Point Perioral Lines at Rest Severity Scale (POLSS) where: 0=None (no lines) [best], 1=Mild (few, shallow lines), 2=Moderate (some moderate lines) or 3=Severe (many deep lines or crevices)[worst]. A negative change from Baseline indicates improvement.|Baseline, Month 4|Participants from the mITT population, all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment, with data available for analysis.||score on a scale||Standard Deviation|Mean
645480|NCT02176356|Secondary|Change From Baseline in the Investigator’s Assessment of the Participant’s Oral Commissures Severity|The investigator assessed the participant's oral commissure using the 4-Point Oral Commissure Severity Scale (OCSS) where: 0=None, 1=Mild, 2=Moderate or 3=Severe. A negative change from Baseline indicates improvement.|Baseline, Month 4|Participants from the mITT population, all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment, with data available for analysis.||score on a scale||Standard Deviation|Mean
645481|NCT02176356|Secondary|Change From Baseline in the Investigator’s Assessment of the Participant’s Nasolabial Folds Severity|The investigator assessed the participants nasolabial folds severity using the 5-Point Nasolabial Fold Severity (NLFS) Scale where: 0=None (no wrinkles) [best], 1=Mild (shallow, just perceptible wrinkle), 2=Moderate (moderately deep wrinkle), 3=Severe (deep wrinkle) or 4= Extreme (very deep wrinkle). A negative change from Baseline indicates improvement.|Baseline, Month 4|Participants from the mITT population, all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment, with data available for analysis.||score on a scale||Standard Deviation|Mean
645482|NCT02176356|Secondary|Change From Baseline in the Investigator’s Assessment of the Participant’s Overall Mid-Face Volume Deficit Using the 6-Point MFVDS|The investigator assessed overall mid-face volume deficit using the Mid-face Volume Deficit Scale (MFVDS) where: 0=None (moon face; fullness) [best], 1=Minimal (flattening), 2=Mild (mild concavity), 3=Moderate (moderate concavity, 4=Significant (significant concavity) and 5=Severe (wasting) [worst]. A negative change from Baseline indicates improvement.|Baseline, Month 4|Participants from the mITT population, all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment, with data available for analysis.||score on a scale||Standard Deviation|Mean
645483|NCT02176356|Secondary|Change From Baseline in Investigator's Global Eyelash Assessment Score (GEAS)|The investigator assessed the participant’s eyelash prominence using the 4-point GEAS where: 1=Minimal (worst), 2=Moderate, 3=Marked and 4=Very Marked (best). A positive change from Baseline indicates improvement.|Baseline, Month 4|Participants from the mITT population, all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment, with data available for analysis.||score on a scale||Standard Deviation|Mean
645484|NCT02176356|Secondary|Change From Baseline in Investigator’s Assessment of the Severity of Crow’s Feet Lines (CFLs) at Maximum Smile Using the FWS|The investigator assessed the severity of the participant’s CFLs using the 4-point FWS where: 0=None, 1=Mild, 2=Moderate or 3=Severe. A negative change from Baseline indicates improvement.|Baseline, Month 4|Participants from the mITT population, all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment, with data available for analysis.||score on a scale||Standard Deviation|Mean
645485|NCT02176356|Secondary|Change From Baseline in Investigator’s Assessment of Severity of Glabellar Lines (GLs) at Maximum Frown Using the Facial Wrinkle Scale (FWS)|The investigator assessed the severity of the participant’s GLs using the 4-point FWS where: 0=None, 1=Mild, 2=Moderate or 3=Severe. A negative change from Baseline indicates improvement.|Baseline, Month 4|Participants from the mITT population, all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment, with data available for analysis.||score on a scale||Standard Deviation|Mean
645486|NCT02176356|Secondary|Participant's Self- Perception of Age (SPA)|Participants assessed SPA by answering the question: How do you think your facial appearance looks compared to your age today? Participants recorded how many years younger or older they thought their facial appearance made them look. A negative result indicates improvement (a younger appearance).|Baseline, Month 4|mITT population included all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment.||years||Standard Deviation|Mean
645487|NCT02176356|Secondary|Change From Baseline in Psychological Well-Being Using a 10-item Questionnaire|Participants assessed their psychological well-being with their facial appearance in mind using a 10-item questionnaire. Possible responses for each question are 1=Definitely disagree, 2=Somewhat disagree, 3=Somewhat agree or 4= Definitely agree. The responses were added across items and transformed to a Rasch score ranging from 0 (worst) to 100 (best). A positive change from Baseline indicates improvement.|Baseline, Month 4|mITT population included all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment.||score on a scale||Standard Deviation|Mean
645488|NCT02176356|Secondary|Change From Baseline in Social Confidence Using an 8-item Questionnaire|Participants assessed their social confidence with their facial appearance in mind in the past week using an 8-item questionnaire. Possible responses for each question are 1=Definitely disagree, 2=Somewhat disagree, 3=Somewhat agree or 4= Definitely agree. The responses were added across items and transformed to a Rasch score ranging from 0 (worst) to 100 (best). A positive change from Baseline indicates improvement.|Baseline, Month 4|mITT population included all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment.||score on a scale||Standard Deviation|Mean
645489|NCT02176356|Secondary|Change From Baseline in Age Appraisal Using a Visual Analogue Scale (VAS)|Participants assessed how old they think they look compared to their actual age using a VAS by placing a mark on a number on a horizontal line where the far left of the line= -15 (look 15 years younger), 0=look current age, to the far right of the line=15 (look 15 years older). A positive change from Baseline indicates improvement.|Baseline, Month 4|Participants from the mITT population, all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment, with data available for analysis.||years||Standard Deviation|Mean
645596|NCT02171611|Secondary|λz for Total Dabigatran|Terminal rate constant in plasma (λz) for total dabigatran.|-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.|pharmacokinetic per-protocol set||1/hour||Geometric Coefficient of Variation|Geometric Mean
645490|NCT02176356|Secondary|Change From Baseline in Aging Appearance Using a 7-item Questionnaire|Participants rated how they look now using a 7-item questionnaire. Possible responses for each question are 1=Definitely disagree, 2=Somewhat disagree, 3=Somewhat agree or 4=Definitely agree. The responses were added across items and transformed to a Rasch score ranging from 0 (worst) to 100 (best). A positive change from Baseline indicates improvement.|Baseline, Month 4|mITT population included all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment.||score on a scale||Standard Deviation|Mean
645491|NCT02176356|Primary|Change From Baseline in Satisfaction With Facial Appearance Overall Using a 10-item Questionnaire|Participants assessed their satisfaction with the way they look right now with their entire face in mind using a 10-item questionnaire. Possible responses to each question were: 1=Very dissatisfied, 2=Somewhat dissatisfied, 3-=Somewhat satisfied and 4=Very satisfied. The responses were added across items and transformed to a Rasch scale ranging from 0 (worst) to 100 (best). A positive change from Baseline indicates improvement.|Baseline, Month 4|Modified Intent-to-Treat (mITT) population included all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment.||score on a scale||Standard Deviation|Mean
645492|NCT02176343|Primary|Mean IOL Rotation|Lens axis orientation (position of the lens within the capsular bag) as indicated by indentations on the IOL was assessed during slit lamp examination. IOL rotation (the difference between the achieved lens axis orientation at visit and achieved axis placement at surgery) was measured in degrees. One eye (primary eye) contributed to the analysis.|Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)|As Treated||degrees||Standard Deviation|Mean
645493|NCT02176343|Primary|Mean Best Corrected Distance Visual Acuity (BCDVA)|VA was tested monocularly with best correction under photopic lighting conditions using a 100% contrast ETDRS chart at 4 m away from the subject. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. One eye (primary eye) contributed to the analysis.|Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)|As Treated||logMAR||Standard Deviation|Mean
645494|NCT02176343|Primary|Mean Uncorrected Intermediate Visual Acuity|VA was tested monocularly without visual correction under photopic lighting conditions using a 100% contrast near ETDRS chart set at 53 cm on the nearpoint rod of the phoropter. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. One eye (primary eye) contributed to the analysis.|Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)|As Treated||logMAR||Standard Deviation|Mean
645495|NCT02176343|Primary|Mean Uncorrected Near Visual Acuity|VA was tested monocularly without visual correction under photopic lighting conditions using a 100% contrast near ETDRS chart set at 40 cm on the nearpoint rod of the phoropter. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. One eye (primary eye) contributed to the analysis.|Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)|As Treated||logMAR||Standard Deviation|Mean
645496|NCT02176343|Primary|Mean Uncorrected Distance Visual Acuity|Visual Acuity (VA) was tested monocularly without visual correction under photopic (well-lit) conditions using a 100% contrast ETDRS chart positioned 4 m from the subject. A +0.25 D spherical power additional lens was used to correct for optical infinity. VA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. One eye (primary eye) contributed to the analysis.|Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)|As Treated||logMAR||Standard Deviation|Mean
645497|NCT02176343|Primary|Percentage of Subjects (With Preoperative Astigmatism > 1.00 D) With Manifest Refraction Cylinder ≤ 1.00 D|Manifest refraction cylinder was measured monocularly with best correction under photopic lighting conditions using a 100% contrast ETDRS chart at 4 m from the subject. One eye (primary eye) contributed to the analysis.|Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)|This analysis population includes all subjects who provided informed consent and were determined eligible based upon the inclusion and exclusion criteria, having preoperative astigmatism > 1.00 D.||percentage of subjects|||Number
645498|NCT02176343|Primary|Percentage of Subjects With Manifest Refraction Cylinder ≤ 0.50 D|Manifest refraction cylinder was measured monocularly with best correction under photopic lighting conditions using a 100% contrast ETDRS chart at 4 m from the subject. One eye (primary eye) contributed to the analysis.|Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)|As Treated||percentage of subjects|||Number
645499|NCT02176343|Primary|Mean Percent Reduction in Cylinder|Manifest refraction cylinder was measured monocularly (each eye separately) with best correction (phoropter or trial lenses) under photopic (well-lit) lighting conditions using a 100% contrast ETDRS chart at 4 meters (m) from the subject. Percent reduction in cylinder was calculated as the difference between the postoperative magnitude of manifest refractive cylinder and the preoperative magnitude of keratometric cylinder divided by the intended reduction in cylinder [defined as the difference between the intended (from toric calculator) magnitude of the postoperative manifest refractive cylinder and the preoperative keratometric cylinder], multiplied by 100%. One eye (primary eye) contributed to the analysis.|Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)|As Treated||percent change||Standard Deviation|Mean
645500|NCT02175771|Secondary|Change From Baseline in Trough Forced Expiratory Volume in 1 Minute (FEV1) Over the 26-Week Treatment Period|"Spirometry measurements were obtained before the AM dose of study drug for the randomization visit (Day 1), at each of the treatment visits and at the early termination visit if applicable. At each visit where FEV1 was assessed, the highest acceptable results from each session were recorded.
The analysis is based on a mixed model for repeated measures (MMRM) with adjustment for baseline FEV1, sex, age, (pooled) investigational center, visit, treatment, and treatment-by-visit. An unstructured covariance matrix is used in the MMRM model."|Baseline (Day 1 pre-treatment), Weeks 2, 6, 10, 14, 18, 22 26, early termination visit if applicable|The full analysis set (FAS) included all participants in the intent-to-treat (ITT) population who received at least 1 dose of study drug and had at least 1 post-baseline trough FEV1 assessment.||liters||Standard Error|Least Squares Mean
645930|NCT02159040|Secondary|Prevalence of MDS/AML Related Gene Mutations|Prevalence of the following mutations in the study population (TP53, EZH2, ETV6, RUNX1, ASXL1, other mutation that is present in ≥ 5% of patients)|Baseline|Only one patient in trial. No analysis will ever be done.|||||
645501|NCT02175771|Secondary|Analysis of 24-Hour Urine Cortisol Free Over the 26-Week Treatment Period|"Samples for 24-hour urine cortisol were collected at baseline (Day 1, pretreatment), and Weeks 14 and 26. For participants requiring early termination (ET), this evaluation was performed at the ET visit. For participants requiring ET for safety reasons, the visit was not delayed in order to collect the 24-hour urine cortisol.
The analysis is based on a mixed model for repeated measures (MMRM) model with adjustment for visit, treatment, and a treatment*visit interaction. The urine cortisol result is log transformed prior to analysis and the results are back transformed after modeling. An unstructured covariance matrix is used in the MMRM model."|Baseline (Day 1, pre-treatment), Weeks 14 and 26 and early termination visit if applicable|A urine cortisol analysis subset of the safety population was defined that included participants whose urine samples did not have confounding factors at any visit that could affect the interpretation of the results.||mcg/24 hours||95% Confidence Interval|Geometric Mean
645502|NCT02175771|Secondary|Shifts From Baseline to Endpoint in Electrocardiogram (ECG) Findings|A 12 lead ECG was conducted at the screening visit and week 26 or the early termination visit. A qualified physician at a central diagnostic center was responsible for interpreting the ECG. The worst post-baseline finding for the participant is summarized. Endpoint refers to the last observation carried forward.|Screening (Day -14), Endpoint (week 26 if study was completed)|Safety population of participants with both screening and endpoint ECGs||Participants|||Count of Participants
645503|NCT02175771|Secondary|Participants With Potentially Clinically Significant Abnormal Vital Signs During the Treatment Period|"Data represents participants with potentially clinically significant (PCS) vital sign values during the Treatment period.
Significance criteria:
Systolic blood pressure - high: >=180 and increase >=20 mmHg
Systolic blood pressure - low: <=90 and decrease >=20 mmHg
Diastolic blood pressure - high: >=105 and increase of >=15 mmHg
Diastolic blood pressure - low: <=50 and decrease of >=15 mmHg
Pulse - high: >=120 and increase of >= 15 beats/minute from baseline
Pulse - low: <=50 and decrease of >=15 beats/minute"|Baseline (Day 1 pre-treatment), Weeks 2, 6, 10, 14, 18, 22 26, Endpoint|Safety population of participants with a baseline and postbaseline vital sign value.||Participants|||Count of Participants
645504|NCT02175771|Secondary|Participants With Positive Swab Test Results for Oral Candidiasis|"Oropharyngeal examinations for visual evidence of oral candidiasis were conducted at each visit by a qualified healthcare professional. Any visual evidence of oral candidiasis during the oropharyngeal exam was evaluated by obtaining and analyzing a swab of the suspect area.
This outcomes indicates how many participants had positive swab test results. The total number of participants who had oropharyngeal exams at each timepoint are specified in the timepoint field. Appropriate therapy was to be initiated immediately at the discretion of the investigator and was not to be delayed for culture confirmation. Participants with a culture-positive infection could continue participation in the study on appropriate anti-infective therapy, provided this therapy was not prohibited by the protocol."|Baseline (Day 1 pre-treatment), Weeks 2, 6, 10, 14, 18, 22 26, Endpoint|Safety population||Participants|||Count of Participants
645505|NCT02175771|Primary|Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period|An adverse event was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relationship of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 to Week 26 of the Treatment Period|"Safety population which included all randomized participants who received at least 1 dose of randomized study drug.
The randomization allocation ratio of 3:1 (study drug: active comparator) should be taken into account when comparing treatment groups within treatment/strength cohorts"||Participants|||Count of Participants
645506|NCT02175745|Primary|Percent Agreement of 18F FDOPA PET With Pathology|For the subset of lesions where pathology is available (mainly biopsied lesions), the accuracy of 18F FDOPA PET as percent agreement with pathology will be calculated. If the number of biopsy positive lesions is at least 10, an estimate of sensitivity will be calculate; if the number of biopsy negative lesions is at least 10 an estimate of specificity will be calculated.|Up to 30 minutes post-injection (at time of scan)|||percentage of agreement (sensitivity)|||Number
645507|NCT02175745|Primary|Number of Suspicious Lesions Identified by 18F FDOPA PET|The number of suspicious lesions will be identified by uptake of F18 FDOPA radiopharmaceutical using a positron emission tomography (PET) scan. Uptake of F-18 FDOPA is a measure of amino acid uptake and metabolism in tumors. Suspicious lesions will be visually identified by a board certified nuclear medicine physician.|Up to 30 minutes after injection of F18 FDOPA|||suspicious lesion(s)|||Number
645508|NCT02175212|Secondary|Late Toxicity|"Defined as the maximal rectal, urinary and cardiovascular (CV) toxicity per patient more than 90 days after completion of RT.
Scoring scales used were the radiation morbidity scoring criteria of the European Organization for Research and Treatment of Cancer–Radiation Therapy Oncology Group (EORTC/RTOG) and the Common Terminology Criteria for Adverse Events (CTCAEs) v 3.0 for the remained toxicity.
CV events were defined according to the World Health Organization criteria"|5 years|||percentage of patients|||Number
645509|NCT02175212|Secondary|Cause-specific Survival|Cause-specific survival included all deaths from prostate cancer or treatment complications, and deaths from unknown causes in patients with either active cancer or a previously documented relapse|5 years|||participants|||Number
645510|NCT02175212|Secondary|Overall Survival: Estimated Percentage of Participants Alive at 5 Years|Overall Survival: defined as the time that elapses from the patient enters the study until the patient dies from any cause.|5 years|||percentage of patients||95% Confidence Interval|Number
645511|NCT02175212|Secondary|Metastasis Free Survival: Estimated Percentage of Participants With Metastasis-free Survival at 5 Years|Metastasis free survival: defined as the time from inclusion in the study (randomization) until the appearance of distant metastases: a positive result in any of the tests performed (scintigraphy, chest radiography, thorax, abdominal and pelvic CT and MRI).|5 years|||percentage of participants||95% Confidence Interval|Number
646054|NCT02156271|Primary|Mean Latency to Persistent Sleep (LPS) Via Polysomnography|Elapsed time from the beginning of the Polysomnography recording to the onset of the first 20 minutes of continuous sleep was measured.|Day 89-90|||minutes||Standard Deviation|Least Squares Mean
645513|NCT02175199|Secondary|Lens Comfort 1-10 Scale Response|"Subject was instructed, Please rate your comfort with the study lenses, using a scale from 1-10, where 1=poor and 10=excellent. Both eyes were rated together."|Day 30|This analysis population includes all randomized subjects with data at visit excluding those who met the critical deviation criteria as specified in the Deviations and Evaluability Plan (DEP).||units on a scale||Standard Deviation|Mean
645514|NCT02175199|Secondary|Lens Comfort Likert Response at Day 14|"Subject indicated agreement with the following statement, These lenses provided the same excellent comfort at the end of two weeks as they did at the beginning of the two weeks using a 4-point Likert scale, where 1=Strongly disagree, 2=Disagree; 3=Agree; 4=Strongly agree. The Top 2 responses (agree, strongly agree) were calculated and reported as a percentage of all responses. Both eyes were rated together. This outcome measure is prespecified for the AIR OPTIX COLORS arm only."|Day 14|This analysis population includes all randomized subjects with data at visit excluding those who met the critical deviation criteria as specified in the Deviations and Evaluability Plan (DEP).||percentage of subjects|||Number
645515|NCT02175199|Primary|Lens Comfort Likert Response at Day 30|"Subject indicated agreement with the following statement, These lenses provided the same excellent comfort at the end of the month as they did at the beginning of the month using a 4-point Likert scale, where 1=Strongly disagree, 2=Disagree; 3=Agree; 4=Strongly agree. The Top 2 responses (agree, strongly agree) were calculated and reported as a percentage of all responses. Both eyes were rated together. This outcome measure was prespecified for the AIR OPTIX COLORS arm only."|Day 30|This analysis population includes all randomized subjects excluding those who met the critical deviation criteria as specified in the Deviations and Evaluability Plan (DEP).||percentage of subjects|||Number
645516|NCT02175121|Secondary|Apparent Clearance (CL/F)|Apparent oral clearance of PF-06291874.|Day 28 (samples taken at 0, 2, 4, 8 and 24 hours after Day 28 dose)|The PK analysis set was defined as all participants who received at least 1 dose of study medication. Samples for participants taking placebo were not analyzed. Number of participants analyzed represents the available number of participants for analysis at post-baseline days.||L/hr||Geometric Coefficient of Variation|Geometric Mean
645517|NCT02175121|Secondary|Minimum Plasma Concentration (Cmin)|Minimum PF-06291874 plasma concentration.|Day 28 (samples taken at 0, 2, 4, 8 and 24 hours after Day 28 dose)|The PK analysis set was defined as all participants who received at least 1 dose of study medication. Samples for participants taking placebo were not analyzed. Number of participants analyzed represents the available number of participants for analysis at post-baseline days.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
645518|NCT02175121|Secondary|Area Under the Concentration-Time Profile From Zero to Time Tau (AUCtau) (Where Tau=24 Hours)|Area under the PF-06291874 plasma concentration-time profile from time zero to time tau, the dosing interval, where tau=24 hours.|Day 28 (samples taken at 0, 2, 4, 8 and 24 hours after Day 28 dose)|The PK analysis set was defined as all participants who received at least 1 dose of study medication. Samples for participants taking placebo were not analyzed. Number of participants analyzed represents the available number of participants for analysis at post-baseline days.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
645519|NCT02175121|Secondary|Time to Reach Cmax (Tmax)|Time to maximum PF-06291874 plasma concentration.|Day 28 (samples taken at 0, 2, 4, 8 and 24 hours after Day 28 dose)|The PK analysis set was defined as all participants who received at least 1 dose of study medication. Samples for participants taking placebo were not analyzed. Number of participants analyzed represents the available number of participants for analysis at post-baseline days.||hour (hr)||Full Range|Median
645520|NCT02175121|Secondary|Maximum Plasma Concentration (Cmax)|Maximum PF-06291874 plasma concentration.|Day 28 (samples taken at 0, 2, 4, 8 and 24 hours after Day 28 dose)|The PK analysis set was defined as all participants who received at least 1 dose of study medication. Samples for participants taking placebo were not analyzed. Number of participants analyzed represents the available number of participants for analysis at post-baseline days.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
645521|NCT02175121|Secondary|Percent Change From Baseline in Lipoprotein A|The Lipoprotein A percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 28 (mean of Days 28 and 29).|Baseline and the mean of Days 28 and 29|The FAS was used in the analysis of the PD parameters. The FAS was defined as all subjects randomized and who received at least 1 dose of randomized treatment. Number of participants analyzed represents the available number of participants for analysis at post-baseline days.||% (percent change)||Standard Deviation|Mean
645522|NCT02175121|Secondary|Percent Change From Baseline in Apolipoprotein B100|The Apolipoprotein B100 was calculated as the difference between total Apolipoprotein B and Apolipoprotein B48 and analyzed the percent change from baseline (defined as mean of Day 0 and Day 1) on Day 28 (mean of Days 28 and 29).|Baseline and the mean of Days 28 and 29|The FAS was used in the analysis of the PD parameters. The FAS was defined as all subjects randomized and who received at least 1 dose of randomized treatment. Number of participants analyzed represents the available number of participants for analysis at post-baseline days.||% (percent change)||Standard Deviation|Mean
645523|NCT02175121|Secondary|Percent Change From Baseline in LDL Size|The LDL size percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 28 (the mean of Days 28 and 29).|Baseline and the mean of Days 28 and 29|The FAS was used in the analysis of the PD parameters. The FAS was defined as all subjects randomized and who received at least 1 dose of randomized treatment. Number of participants analyzed represents the available number of participants for analysis at post-baseline days.||% (percent change)||Standard Deviation|Mean
645524|NCT02175121|Secondary|Percent Change From Baseline in Total LDL Particles|Total LDL particles percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 28 (the mean of Days 28 and 29).|Baseline and the mean of Days 28 and 29|The FAS was used in the analysis of the PD parameters. The FAS was defined as all subjects randomized and who received at least 1 dose of randomized treatment. Number of participants analyzed represents the available number of participants for analysis at post-baseline days.||% (percent change)||Standard Deviation|Mean
645525|NCT02175121|Secondary|Percent Change From Baseline in Very Small LDL Particles|Very small LDL particles percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 28 (the mean of Days 28 and 29).|Baseline and the mean of Days 28 and 29|The FAS was used in the analysis of the PD parameters. The FAS was defined as all subjects randomized and who received at least 1 dose of randomized treatment. Number of participants analyzed represents the available number of participants for analysis at post-baseline days.||% (percent change)||Standard Deviation|Mean
645526|NCT02175121|Secondary|Percent Change From Baseline in Small LDL Particles|Small LDL particles percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 28 (the mean of Days 28 and 29).|Baseline and the mean of Days 28 and 29|The FAS was used in the analysis of the PD parameters. The FAS was defined as all subjects randomized and who received at least 1 dose of randomized treatment. Number of participants analyzed represents the available number of participants for analysis at post-baseline days.||% (percent change)||Standard Deviation|Mean
645527|NCT02175121|Secondary|Percent Change From Baseline in Medium Small LDL Particles|Medium small LDL particles percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 28 (the mean of Days 28 and 29).|Baseline and the mean of Days 28 and 29|The FAS was used in the analysis of the PD parameters. The FAS was defined as all subjects randomized and who received at least 1 dose of randomized treatment. Number of participants analyzed represents the available number of participants for analysis at post-baseline days.||% (percent change)||Standard Deviation|Mean
645528|NCT02175121|Secondary|Percent Change From Baseline in Large LDL Particles|Large LDL particles percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 28 (the mean of Days 28 and 29).|Baseline and the mean of Days 28 and 29|The FAS was used in the analysis of the PD parameters. The FAS was defined as all subjects randomized and who received at least 1 dose of randomized treatment. Number of participants analyzed represents the available number of participants for analysis at post-baseline days.||% (percent change)||Standard Deviation|Mean
645529|NCT02175121|Secondary|Percent Change From Baseline in Oxidized LDL|Oxidized LDL percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 28 (the mean of Days 28 and 29).|Baseline and the mean of Days 28 and 29|The FAS was used in the analysis of the PD parameters. The FAS was defined as all subjects randomized and who received at least 1 dose of randomized treatment. Number of participants analyzed represents the available number of participants for analysis at post-baseline days.||% (percent change)||Standard Deviation|Mean
645530|NCT02175121|Secondary|Percent Change From Baseline in Non-HDL-C|Non-HDL-C percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 14, and the mean of Days 28 and 29.|Baseline, Day 14 and the mean of Days 28 and 29|The FAS was used in the analysis of the PD parameters. The FAS was defined as all subjects randomized and who received at least 1 dose of randomized treatment. N in percent change from Baseline when different, represents the available number of participants for analysis at post-baseline days.||% (percent change)||Standard Deviation|Mean
645531|NCT02175121|Secondary|Percent Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C)|HDL-C percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 14, and the mean of Days 28 and 29.|Baseline, Day 14 and the mean of Days 28 and 29|The FAS was used in the analysis of the PD parameters. The FAS was defined as all subjects randomized and who received at least 1 dose of randomized treatment. N in percent change from Baseline when different, represents the available number of participants for analysis at post-baseline days.||% (percent change)||Standard Deviation|Mean
645532|NCT02175121|Secondary|Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C)|LDL-C percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 14, and the mean of Days 28 and 29.|Baseline, Day 14 and the mean of Days 28 and 29|The FAS was used in the analysis of the PD parameters. The FAS was defined as all subjects randomized and who received at least 1 dose of randomized treatment. N in percent change from Baseline when different, represents the available number of participants for analysis at post-baseline days.||% (percent change)||Standard Deviation|Mean
645533|NCT02175121|Secondary|Percent Change From Baseline in Total Cholesterol|Total cholesterol percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 14, and the mean of Days 28 and 29.|Baseline, Day 14 and the mean of Days 28 and 29|The FAS was used in the analysis of the PD parameters. The FAS was defined as all subjects randomized and who received at least 1 dose of randomized treatment. N in percent change from Baseline when different, represents the available number of participants for analysis at post-baseline days.||% (percent change)||Standard Deviation|Mean
645534|NCT02175121|Secondary|Percent Change From Baseline in Triglycerides|Triglycerides percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 14, and the mean of Days 28 and 29.|Baseline, Day 14 and the mean of Days 28 and 29|The FAS was used in the analysis of the PD parameters. The FAS was defined as all subjects randomized and who received at least 1 dose of randomized treatment. N in percent change from Baseline when different, represents the available number of participants for analysis at post-baseline days.||% (percent change)||Standard Deviation|Mean
645535|NCT02175121|Secondary|Change From Baseline in Fasting Plasma Glucose|Fasting plasma glucose response change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 14, and the mean of Days 28 and 29.|Baseline, Day 14 and the mean of Days 28 and 29|The FAS was used in the analysis of the PD parameters. The FAS was defined as all subjects randomized and who received at least 1 dose of randomized treatment. N in change from Baseline when different, represents the available number of participants for analysis at post-baseline days.||mg/dL||Standard Deviation|Mean
645536|NCT02175121|Secondary|Change From Baseline in Mean Daily Glucose|The mean daily glucose was determined from the area under the concentration (AUC) of the glucose concentrations measured at nominal times 0, 0.5, 1, 1.5, 2, 4, 6, 10, 12, 15 and 24 hours post dose. Mean daily glucose change from baseline (defined as Day 0) on Day 28.|Baseline and Day 28|The full analysis set (FAS) was used in the analysis of the pharmacodynamic (PD) parameters. The FAS was defined as all subjects randomized and who received at least 1 dose of randomized treatment. Number of participants analyzed represents the available number of participants for analysis at post-baseline days.||mg/dL||Standard Deviation|Mean
645549|NCT02173535|Primary|Number of Subject in Agreement (Defines Eyes)|"Subjects' responses to the question Define my eye were categorized into a binary variable. If a subject responded Agrees Somewhat or Agrees Strongly then response=1. If a subject responds Neither Agrees nor Disagrees, Disagrees Somewhat Disagrees Strongly then response=0. The number of subjects with response=1 was reported for each lens."|15-20 Minutes Post Lens Insertion|Subjects that completed all study visits without a major protocol deviation impacting any of the primary endpoints||Participants|||Number
645597|NCT02171611|Secondary|Tmax for Free Dabigatran|Time from dosing to the maximum concentration of the analyte in plasma (tmax) for free dabigatran|-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.|pharmacokinetic per-protocol set||hour||Full Range|Median
645537|NCT02175121|Primary|Number of Participants With Electrocardiogram (ECG) Data Meeting Criteria of Potential Clinical Concern|ECG criteria of potential clinical concern were 1), time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization (QRS interval): >=140 msec; >=50% increase from baseline; 2), the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization (PR interval): >=300 milliseconds (msec); >=25 percent (%) increase when baseline >200 msec; or increase >=50% when baseline less than or equal to (<=)200 msec; 3), time from ECG Q wave to the end of the T wave corresponding to electrical systole corrected for heart rate using Fridericia’s formula (QTcF interval): absolute value >=450 - <480 msec, >=480-<500 msec, >=500 msec; increase from baseline >=30 - <60, >=60 msec.|Baseline up to 10-14 days after last dose of study drug, up to 42 days|The safety analysis set was defined as all participants who received at least 1 dose of study drug.||participants|||Number
645538|NCT02175121|Primary|Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Criteria of Potential Clinical Concern|Vital Signs included seated supine systolic and diastolic blood pressure (BP) and pulse rate. Vital signs criteria of potential clinical concern were 1), BP: systolic (SBP) greater than or equal to (>=) 30 millimeters of mercury (mm Hg) change from baseline, systolic less than (<) 90 mm Hg; diastolic BP (DBP) >=20 mm Hg change from baseline, diastolic <50 mm Hg; 2), pulse rate <40 or greater than (>) 120 beats per minute (bpm).|Baseline up to 10-14 days after last dose of study drug, up to 42 days|The safety analysis set was defined as all participants who received at least 1 dose of study drug.||participants|||Number
645539|NCT02175121|Primary|Number of Participants With Laboratory Test Abnormalities|The total number of participants with laboratory test abnormalities (without regard to baseline abnormality) was assessed. Clinical laboratory tests included hematology, chemistry, urinalysis, and some other tests.|Baseline up to 10-14 days after last dose of study drug, up to 42 days|The safety analysis set was defined as all participants who received at least 1 dose of study drug.||participants|||Number
645540|NCT02175121|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs), or Serious Adverse Events (SAEs), or Hypoglycemic Adverse Events (HAE) or Withdrawals Due to Adverse Events (AEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. An HAE was identified by characteristic symptoms or blood glucose levels. TEAEs are events between first dose of study drug and up to 10-14 days after last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state.|Baseline up to 10-14 days after last dose of study drug, up to 42 days|The safety analysis set was defined as all participants who received at least 1 dose of study drug.||participants|||Number
645541|NCT02173769|Secondary|Patient Satisfaction: Satisfaction With Handling of Inhaler|"Patient satisfaction with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 Microgram plus Striverdi Respimat.
Patient´s satisfaction with study treatment and handling of the Respimat inhaler was assessed on a 7-point-ordinal scale extending from very satisfied (1) to very unsatisfied (7)."|4-6 weeks|FAS including patients with available handling of inhaler satisfaction data||Percentage of participants|||Number
645542|NCT02173769|Secondary|Patient Satisfaction: Satisfaction With Inhaler|"Patient satisfaction with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 Microgram plus Striverdi Respimat.
Patient´s satisfaction with study treatment and handling of the Respimat inhaler was assessed on a 7-point-ordinal scale extending from very satisfied (1) to very unsatisfied (7)."|4-6 weeks|FAS including patients with available inhaler satisfaction data||Percentage of participants|||Number
645543|NCT02173769|Secondary|Patient Satisfaction: Overall Satisfaction|"Patient satisfaction with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 Microgram plus Striverdi Respimat.
Patient´s satisfaction with study treatment and handling of the Respimat inhaler was assessed on a 7-point-ordinal scale extending from very satisfied (1) to very unsatisfied (7)."|4-6 weeks|FAS including patients with available satisfaction data||Percentage of participants|||Number
645544|NCT02173769|Secondary|General Health of the Patient After 4-6 Weeks|"General health of the patient as evaluated by the physician using the Physician´s Global Evaluation (PGE) score after 4-6 weeks.
The PGE score consists of an 8-point-scale which extends from 1 (very bad) to 8 (excellent)."|4-6 weeks|FAS including patients with available PGE score at end of study visit||Percentage of participants|||Number
645545|NCT02173769|Secondary|General Health of the Patient at Baseline|"General health of the patient as evaluated by the physician using the Physician´s Global Evaluation (PGE) score at the initial examination.
The PGE score consists of an 8-point-scale which extends from 1 (very bad) to 8 (excellent)."|Baseline|FAS including patients with available PGE score at baseline||Percentage of participants|||Number
645546|NCT02173769|Secondary|Absolute Changes in the PF-10 Score|"Absolute changes in the PF-10 score.
The PF-10 score is a subscale of the quality of life questionnaire Short Form 36 (SF-36) and contains 10 questions concerning physical activity and capacity. The total score ranges from 0 to 100. A higher score indicates a better physical functioning."|4-6 weeks|FAS||Units on a scale||Standard Deviation|Mean
645547|NCT02173769|Primary|"Percentage of Participants With Therapeutic Success"|"Percentage of participants with therapeutic success defined as a 10-point increase in the physical activity assessed by patient´s questionnaire (PF-10) score between the initial examination and after 4-6 weeks.
The PF-10 score is a subscale of the quality of life questionnaire Short Form 36 (SF-36) and contains 10 questions concerning physical activity and capacity. The total score ranges from 0 to 100. A higher score indicates a better physical functioning."|Baseline and 4-6 weeks|Full analysis (FAS) which includes all patients enrolled in the study who did not violated any inclusion or exclusion criteria.||Percentage of participants|||Number
645548|NCT02173535|Primary|Number of Subject in Agreement (Enhance Eyes)|"Subjects' responses to the question Enhance my overall appearance were categorized into a binary variable. If a subject responded Agrees Somewhat or Agrees Strongly then response=1. If a subject responds Neither Agrees nor Disagrees, Disagrees Somewhat Disagrees Strongly then response=0. The number of subjects with response=1 was reported for each lens."|15-20 Minutes Post Lens Insertion|Subjects that completed all study visits without a major protocol deviation impacting any of the primary endpoints||Participants|||Number
645635|NCT02170532|Secondary|Change in 8 Hour Area-under-the-curve FEV1||0 to 8 hours post dose|||percentage of change||Standard Deviation|Mean
645550|NCT02173535|Primary|Number of Subject in Agreement (Bigger Eyes)|"Subjects' responses to the question Make my eye look bigger were categorized into a binary variable. If a subject responded Agrees Somewhat or Agrees Strongly then response=1. If a subject responds Neither Agrees nor Disagrees, Disagrees Somewhat Disagrees Strongly then response=0. The number of subjects with response=1 was reported for each lens."|15-20 Minutes Post Lens Insertion|Subjects that completed all study visits without a major protocol deviation impacting any of the primary endpoints||Participants|||Number
645551|NCT02173392|Secondary|Immunogenicity|Presence of binding or neutralizing anti-brodalumab antibodies|60 days|||participants|||Number
645552|NCT02173392|Primary|Area Under the Drug Concentration Time Curve From Zero to the Time of Last Quantifiable Concentration of Brodalumab|Pharmacokinetic parameter estimates after a 210 mg dose of brodalumab, and after two 210 mg doses of brodalumab delivered subcutaneously as a single prefilled syringe (PFS) injection|60 days|Participants analyzed is a combination of period 1 and period 2 participants results, thus the higher number of overall participants analyzed||(day*mg/mL)||Standard Deviation|Mean
645553|NCT02173392|Primary|Pharmacokinetic Parameters for the Maximum Amount of Observed Brodalumab Concentration for Treatment A and Treatment B.|Pharmacokinetic parameter estimates after a 210 mg dose of brodalumab, and after two 210 mg doses of brodalumab delivered subcutaneously as a single prefilled syringe (PFS) injection|60 days|Number of participants analyzed reflects the combination of participants analyzed at period one and then again at period two||milligrams per milliliter||Standard Deviation|Mean
645554|NCT02173054|Secondary|Reduction of Severity of Acne: Acne Severity Index (ASI)|"The ASI score was calculated from the number of papules + (2 x pustules) + (comedones/4)
Decrease of ASI score are considered to be a better outcome"|baseline, 2nd week, 4th week and 8th week|||units on a scale||Standard Deviation|Mean
645555|NCT02173054|Primary|Skin Tolerability: Transepidermal Water Loss (TEWL)|Skin tolerability was assessed by measuring TEWL with the Tewameter TM300|Skin tolerability was assessed at baseline and week 8. The changes of skin tolerability between baseline and 8th week of the 3 groups were compared.|||g/m^2h||Standard Deviation|Mean
645556|NCT02173054|Primary|Skin Tolerability: Skin Sebum Content and Skin Hydration|Skin tolerability was assessed by measuring the skin surface sebum content, skin hydration with the Sebumeter SM815 and Corneometer CM825, respectively|Skin tolerability was assessed at baseline and week 8. The changes of skin tolerability between baseline and 8th week of the 3 groups were compared.|||µg/cm^2||Standard Deviation|Mean
645557|NCT02173054|Secondary|Reduction of Severity of Acne|"Evaluation from mean counts of inflammatory, noninflammatory, and total acne lesions at baseline, and at 2, 4, and 8 weeks
Total acne lesions = inflammatory + noninflammatory acne lesions
Reduction of lesions counts are considered to be a better outcome"|baseline, 2nd week, 4th week and 8th week|||Lesions||Standard Deviation|Mean
645558|NCT02173054|Primary|Reduction of Undesirable Effects|"Undesirable effects were evaluated from skin's condition/signs(erythema, dryness and scaling) are evaluated by dermatologist. (none; mild; moderate; severe) and subject interview/symptoms(stinging/burning and pruritis) are evaluated by participants.(none; mild; moderate; severe). There were assessed at 2nd week, 4th week, and 8th week.
The worst score of each parameter which was defined as the worst local tolerance score is demonstrated and compared among 3 groups as shown."|2nd week, 4th week, and 8th week|The reasons for drop out were lack of compliance (n=1, group A: adapalene gel alone) and consent withdrawal at patient's request (n=1, group C: adapalene with Eucerin)||participants|||Number
645559|NCT02172755|Secondary|AUC0-t - Area Under the Plasma Concentration-time Curve to Last Measurable Time Point|"Single-dose period: Day 1 at pre-dose, and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose.
Multiple-dose period: from Day 5 to Day 11 inclusive, early in the morning, before the daily dose (for trough levels).
Day 12: pre-dose, and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-last dose.
BIA 2-194, BIA 2-195, and oxcarbazepine are metabolites of BIA 2-093"|Day 1 at pre-dose, and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose From Day 5 to Day 11 inclusive, before the daily dose (for trough levels). On Day 12, pre-dose, and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours p|||ng.h/mL||Standard Deviation|Mean
645560|NCT02172755|Secondary|Tmax - Time of Maximum Observed Concentration|"Single-dose period: Day 1 at pre-dose, and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose.
Multiple-dose period: from Day 5 to Day 11 inclusive, early in the morning, before the daily dose (for trough levels).
Day 12: pre-dose, and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-last dose.
BIA 2-194, BIA 2-195, and oxcarbazepine are metabolites of BIA 2-093"|Day 1 at pre-dose, and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose From Day 5 to Day 11 inclusive, before the daily dose (for trough levels). On Day 12, pre-dose, and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours p|||hours||Standard Deviation|Mean
645561|NCT02172755|Primary|Maximum Drug Concentration (Cmax)|"Single-dose period: Day 1 at pre-dose, and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose.
Multiple-dose period: from Day 5 to Day 11 inclusive, early in the morning, before the daily dose (for trough levels).
Day 12: pre-dose, and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-last dose.
BIA 2-194, BIA 2-195, and oxcarbazepine are metabolites of BIA 2-093"|Day 1 at pre-dose, and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose From Day 5 to Day 11 inclusive, before the daily dose (for trough levels). On Day 12, pre-dose, and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours p|||ng/mL||Standard Deviation|Mean
645562|NCT02172742|Secondary|AUCτ - Steady-state Area Under the Plasma Concentration-time Profile Over 24 h|Steady-state Area Under the Plasma Concentration-time Profile Over 24 h of BIA 2-005 (BIA 2-093 metabolite) and Digoxin|Day 6 and Day 7: pre-dose; Day 8: pre-dose, ½, 1, 2, 3, 4, 6, 8, 12, 18, and 24 hours post-dose|||ng*h/mL||Standard Deviation|Mean
645563|NCT02172742|Secondary|Tmax - Time of Occurrence of Cmax at Steady-state|Time of Occurrence of Cmax Maximum steady-state plasma concentration of BIA 2-005 (BIA 2-093 metabolite) and Digoxin|Day 6 and Day 7: pre-dose; Day 8: pre-dose, ½, 1, 2, 3, 4, 6, 8, 12, 18, and 24 hours post-dose|||hours||Full Range|Median
645564|NCT02172742|Primary|Cmax - Maximum Steady-state Plasma Concentration|Cmax - Maximum steady-state plasma concentration of BIA 2-005 (BIA 2-093 metabolite) and Digoxin|Day 6 and Day 7: pre-dose; Day 8: pre-dose, ½, 1, 2, 3, 4, 6, 8, 12, 18, and 24 hours post-dose|||ng/mL||Standard Deviation|Mean
645684|NCT02169453|Primary|AUEC0-24 - Area Under the Effect-time Curve From t=0h to t=24h||pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose|||pmol/mg Hb/h.h||Standard Deviation|Mean
645565|NCT02172625|Secondary|Superoxide Dismutase (SOD)|Blood was collected in vacuum-sealed tubes designed to contain and preserve specimens in a manner appropriate for their respective analysis and shipped to Geneva Diagnostics for analysis using proprietary methodology (Oxidative Stress Analysis 2.0, Blood). Genova Diagnostics is a global, fully accredited clinical laboratory, located in Asheville, NC [Licensed by Clinical Laboratory Improvement Amendments (CLIA) Certification number #34D0655571]. This is another protective antioxidant enzyme measured from whole blood. The SOD enzymatic assay from Genova Diagnostics is designed to measure the activity of the SOD enzyme in the cytosol. The SOD assay is designed to measure the activity of SOD enzyme from whole blood. The SOD activity is determined spectrophotometrically based on the ability of the SOD compound to reduce reactive oxygen species in an enzymatic reaction necessary for the produc tion of an optically active compound.|Baseline, 30 days, 57 days, and 88 days|||U/g Hb x 1000||Standard Deviation|Mean
645566|NCT02172625|Secondary|Whole Blood Glutathione Content (GSH)|Blood was collected in vacuum-sealed tubes designed to contain and preserve specimens in a manner appropriate for their respective analysis and shipped to Geneva Diagnostics for analysis using proprietary methodology (Oxidative Stress Analysis 2.0, Blood). Genova Diagnostics is a global, fully accredited clinical laboratory, located in Asheville, NC [Licensed by Clinical Laboratory Improvement Amendments (CLIA) Certification number #34D0655571]. The total whole blood glutathione assay is designed to measure the level of glutathione in whole blood. The samples is first completely lysed and proteins are precipitated. The supernatant is then reduced and combined with a spectrophotometrically reactive compound which generates a detectable absorption peak. When compared to known concentrations of glutathione under the same reaction conditions a determination of glutathione levels in blood is determined.|Baseline and 88 (SD 4) days. All pre-exercise values.|Runners from the Louisville, KY, USA, community||umol/L x 10||Standard Deviation|Mean
645567|NCT02172625|Secondary|Total Antioxidant Capacity (TAC)|Blood was collected in vacuum-sealed tubes designed to contain and preserve specimens in a manner appropriate for their respective analysis and shipped to Geneva Diagnostics for analysis using proprietary methodology (Oxidative Stress Analysis 2.0, Blood). Genova Diagnostics is a global, fully accredited clinical laboratory, located in Asheville, NC[Licensed by Clinical Laboratory Improvement Amendments (CLIA) Certification number #34D0655571]. Total antioxidant capacity (TAC). The TAC measures the overall collective power of the blood to neutralize free radicals. Specifically, the TAC assay measures the antioxidant capacity of a serum sample via the ability of the antioxidants within the sample to neutralize a spectrophotometrically active compound that is optically active when oxidized. The decrease in color intensity of the compound when compared to the standard, Trolox, under the same reaction conditions is equivalent to the serum antioxidant capacity of the serum sample.|Baseline and 88 (SD 4) days. All pre-exercise values.|Runners from the Louisville, KY, USA, community||mmol/L||Standard Deviation|Mean
645568|NCT02172625|Secondary|Quality of Life as Assessed by the World Health Organization Quality of Life Questionnaire (Brief)|"This is a questionnaire that assessed quality of life across 4 domains over the supplementation period.
Physical Health domain: Scores range from 7 (lowest) to 35 (best, most favorable).
Psychological Health Domain: Scores range from 6 (lowest) to 30 (best, most favorable).
Social Relationships Domain: Scores range from 3 (lowest) to 15 (best, most favorable).
Environment Domain: Scores range from 8 (lowest) to 40 (best, most favorable)."|Baseline, 30 days, 57 days, and 88 days|Healthy community runners.||units on a scale||Standard Deviation|Mean
645569|NCT02172625|Secondary|Glutathione Peroxidase (GPX)|Blood was collected in vacuum-sealed tubes designed to contain and preserve specimens in a manner appropriate for their respective analysis and shipped to Geneva Diagnostics for analysis using proprietary methodology (Oxidative Stress Analysis 2.0, Blood). Genova Diagnostics is a global, fully accredited clinical laboratory, located in Asheville, NC [Licensed by Clinical Laboratory Improvement Amendments (CLIA) Certification number #34D0655571]. Glutathione peroxidase (GPX). This is a measure of glutathione peroxidase activity in red blood cell lysates sampled fromwhole blood. The level of GPX in the sample is determined spectrophotometrically based on the ability of the compound to catalyze a reduction reac- tion in the presence of glutathione. The change in the absorption level of the substrate is then utilized to determine the level of GPX present in the sample. The result is expressed as units of GPX relative to the gram amount of hemoglobin in the sample.|Baseline, 30 days, 57 days, and 88 days|||U/g Hb||Standard Deviation|Mean
645570|NCT02172625|Primary|Lipid Peroxides (TBARS)|Lipid peroxides (TBARS) is a measure of oxidative damage in the blood. The full report can be found here: http://dx.doi.org/10.1371/journal.pone.0160559|Baseline, 30 days, 57 days, and 88 days|The values reported here are the values in a fasted state. The full report can be found here: http://dx.doi.org/10.1371/journal.pone.0160559||umol/L||Standard Deviation|Mean
645571|NCT02172625|Primary|5-km Running Time|5-km running performance time was measured twice at the beginning of the study, and then once post-supplementation. The best 5 km time from both initial sessions was counted as the baseline 5-km time. The full report can be found here: http://dx.doi.org/10.1371/journal.pone.0160559|Baseline and 88 (SD 4) days|Runners from the Louisville, KY, USA, community||minutes||Standard Deviation|Mean
645572|NCT02172040|Secondary|Mean Change in Average Daytime (9:00 to 21:00) Ambulatory Systolic Blood Pressure (SBPday) - Secondary Endpoint||Baseline and 2 weeks|ITT Population as described for primary outcome||mmHg||Standard Deviation|Mean
645573|NCT02172040|Secondary|Mean Log-transformed Celecoxib Plasma Concentration||24 hours post-dose on Day 14|PK population: subset of overall trial population, consisting of participants at Investigational sites capable of obtaining PK blood samples in a protected light environment. No celecoxib PK statistical analyses were performed for the PK participants in the amlodipine+placebo and placebo+placebo arms.||log(ng/mL)||Standard Deviation|Mean
645574|NCT02172040|Secondary|Mean Log-transformed Amlodipine Plasma Concentration||24 hours post-dose on Day 14|PK population: subset of overall trial population, consisting of participants at Investigational sites capable of obtaining PK blood samples in a protected light environment. No amlodipine PK statistical analyses were performed for the PK participants in the placebo+celecoxib and placebo+placebo arms.||log(pg/mL)||Standard Deviation|Mean
645575|NCT02172040|Secondary|Mean Non-transformed Celecoxib Plasma Concentration||24 hours post-dose on Day 14|PK population: subset of overall trial population, consisting of participants at Investigational sites capable of obtaining PK blood samples in a protected light environment. No celecoxib PK statistical analyses were performed for the PK participants in the amlodipine+placebo and placebo+placebo arms.||ng/mL||Standard Deviation|Mean
645685|NCT02169453|Primary|tEmax - Time of Occurrence of Emax||pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose|||hours||Standard Deviation|Mean
645576|NCT02172040|Secondary|Mean Non-transformed Amlodipine Plasma Concentration||24 hours post-dose on Day 14|Pharmacokinetic (PK) population: subset of overall trial population, consisting of participants at Investigational sites capable of obtaining PK blood samples in a protected light environment. No amlodipine PK statistical analyses were performed for the PK participants in the placebo+celecoxib and placebo+placebo arms.||pg/mL||Standard Deviation|Mean
645577|NCT02172040|Secondary|Mean Change in Average Night-time (01:00 to 06:00) Ambulatory Diastolic Blood Pressure (DBPnight)||Baseline and 2 weeks|ITT Population as defined for primary outcome||mmHg||Standard Deviation|Mean
645578|NCT02172040|Secondary|Mean Change in Average Daytime (9:00 to 21:00) Ambulatory Diastolic Blood Pressure (DBPday)||Baseline and 2 weeks|ITT Population as described for primary outcome||mmHg||Standard Deviation|Mean
645579|NCT02172040|Secondary|Mean Change in Average 24-hour Ambulatory Diastolic Blood Pressure (DBP24h)||Baseline and 2 weeks|ITT Population as described for primary outcome||mmHg||Standard Deviation|Mean
645580|NCT02172040|Secondary|Mean Change in Average Night-time (01:00 to 06:00) Ambulatory Systolic Blood Pressure (SBPnight)||Baseline and 2 weeks|ITT Population as described for primary outcome||mmHg||Standard Deviation|Mean
645581|NCT02172040|Secondary|Mean Change in Average 24-hour Ambulatory Systolic Blood Pressure (SBP24h)||Baseline and 2 weeks|ITT population as described for primary outcome||mmHg||Standard Deviation|Mean
645582|NCT02172040|Primary|Frequency of Adverse Events (Number of Participants Affected/Number of Participants at Risk)|Including any untoward medical occurrence in a participant administered study drug, which do not necessarily have a causal relationship with the study drug [i.e., any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not related to the study drug].|1 month|Safety population: all randomized participants who received at least one dose of study drug.||Participants|||Count of Participants
645583|NCT02172040|Primary|Mean Change in Average Daytime (9:00 to 21:00) Ambulatory Systolic Blood Pressure (SBPday) - Primary Endpoint||Baseline and 2 weeks|Intent-to-treat (ITT): All randomized participants who received at least 1 dose of study drug and had at least a valid baseline ambulatory blood pressure monitor measurement (ABPM) and either: a) a valid Day 13-14 ABPM, where participant completed treatment or b) a valid Day 6-7 or Day 0-1 ABPM, where participant was withdrawn early.||mmHg||Standard Deviation|Mean
645584|NCT02171611|Secondary|Assessment of Tolerability by Investigator.|Tolerability will be assessed by the investigator according to the categories good, satisfactory, not satisfactory and bad.|From first drug administration until 7 days after the last drug administration of Dabigatran, ie., up to 10 days.|Treated Set||Percentage of Participants|||Number
645585|NCT02171611|Secondary|Percentage of Participants With Drug-related Adverse Events|Percentage of participants with investigator defined drug−releated Adverse events.|From first drug administration until 7 days after the last drug administration of Dabigatran, ie., up to 10 days.|Treated set||Percentage of participants|||Number
645586|NCT02171611|Secondary|Percentage of Participants With Findings in Physical Examination, Vital Signs , Pulse Rate (PR)), 12-lead ECG, Clinical Laboratory Tests.|"Percentage of participants with findings in Physical examination, Vital signs (blood pressure (BP), pulse rate (PR)), 12-lead ECG (electrocardiogram), Clinical laboratory tests (haematology, clinical chemistry and urinalysis). Relevant findings or worsening of baseline conditions were reported as Adverse events.
There were no clinically relevant finding reported for Physical examination, Vital signs (blood pressure, pulse rate), 12-lead ECG and Clinical laboratory tests."|From first drug administration until 7 days after the last drug administration of Dabigatran, ie., up to 10 days.|Treated Set||Percentage of participants|||Number
645587|NCT02171611|Secondary|Vz/F for Free Dabigatran|Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F) for free dabigatran.|-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.|pharmacokinetic per-protocol set||Liter||Geometric Coefficient of Variation|Geometric Mean
645588|NCT02171611|Secondary|Vz/F for Total Dabigatran|Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F) for total dabigatran.|-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.|pharmacokinetic per-protocol set||Liter||Geometric Coefficient of Variation|Geometric Mean
645589|NCT02171611|Secondary|CL/F for Free Dabigatran|Apparent clearance of the analyte in plasma following extravascular administration (CL/F) for free dabigatran.|-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.|pharmacokinetic per-protocol set||mL (milliliter)/min (minute)||Geometric Coefficient of Variation|Geometric Mean
645590|NCT02171611|Secondary|CL/F for Total Dabigatran|Apparent clearance of the analyte in plasma following extravascular administration (CL/F) for total dabigatran.|-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.|pharmacokinetic per-protocol set||mL (milliliter)/min (minute)||Geometric Coefficient of Variation|Geometric Mean
645591|NCT02171611|Secondary|MRTpo for Free Dabigatran|Mean residence time of the analyte in the body after po administration (MRTpo) for free dabigatran.|-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.|pharmacokinetic per-protocol set||hour||Geometric Coefficient of Variation|Geometric Mean
645592|NCT02171611|Secondary|MRTpo for Total Dabigatran|Mean residence time of the analyte in the body after po administration (MRTpo) for total dabigatran.|-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.|pharmacokinetic per-protocol set||hour||Geometric Coefficient of Variation|Geometric Mean
645593|NCT02171611|Secondary|t1/2 for Free Dabigatran|Terminal half-life of the analyte in plasma (t1/2) for free dabigatran.|-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.|pharmacokinetic per-protocol set||hour||Geometric Coefficient of Variation|Geometric Mean
645686|NCT02169453|Primary|Emax - Maximum Inhibition of COMT Activity|Emax - Maximum inhibition of Catechol-O-Methyltransferase (COMT) activity|pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose|||pmol/mg Hb/h||Standard Deviation|Mean
645598|NCT02171611|Secondary|Tmax for Total Dabigatran|Time from dosing to the maximum concentration of the analyte in plasma (tmax) for total dabigatran|-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.|pharmacokinetic per-protocol set||hour||Full Range|Median
645599|NCT02171611|Secondary|AUC0-tz for Free Dabigatran|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz) for free dabigatran.|-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.|pharmacokinetic per-protocol set||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
645600|NCT02171611|Secondary|AUC0-tz for Total Dabigatran|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz) for total dabigatran.|-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.|pharmacokinetic per-protocol set||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
645601|NCT02171611|Primary|Cmax for Free Dabigatran|Maximum measured concentration of the analyte in plasma (Cmax) for free dabigatran|-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.|pharmacokinetic per-protocol set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
645602|NCT02171611|Primary|Cmax for Total Dabigatran|Maximum measured concentration of the analyte in plasma (Cmax) for total dabigatran.|-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.|pharmacokinetic per-protocol set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
645603|NCT02171611|Primary|AUC0-inf for Free Dabigatran|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf) for free dabigatran.|-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.|pharmacokinetic per-protocol set||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
645604|NCT02171611|Primary|AUC0-inf for Total Dabigatran|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf) for total dabigatran.|-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.|PK-Per protocol set (PK-PPS): This subject set included all subjects in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations with respect to the evaluation of relative bioavailability and who did not vomit at or before 2 times the median tmax.||ng(nanogram)*h(hour)/mL(milliliter)||Geometric Coefficient of Variation|Geometric Mean
645605|NCT02171247|Primary|Attenuation of the Ascending Aorta and Coronary Arteries|The investigator will measure the length of visualized coronary artery for the left anterior descending, left circumflex and right coronary arteries as a way of quantifying visualization of distal coronary segments.|during scan, approximately 3 hours|||CNR||Standard Deviation|Mean
645606|NCT02171247|Primary|Motion Artifact|The outcome will be measured by individual scores. The scores from multiple readers will be averaged.|during scan, approximately 3 hours|Data was not collected and therefore not analysed|||||
645607|NCT02171247|Primary|Image Quality|Depiction of Branch Vessels - coronary branch depiction was performed as consensus decisions of two blinded radiologists. Criteria used was abscence or presence of vessels.|during scan, approximately 3 hours|||% of coronary branches visualized|||Number
645608|NCT02171247|Primary|Contrast to Noise Ratio|Contrast-to-noise ratios (CNRs) were calculated as follows: CNR = (vascular attenuation − myocardium attenuation) / SD of mean noise attenuation.|during scan, approximately 3 hours|||CNR||Standard Deviation|Mean
645609|NCT02171234|Primary|Total Number of Adverse Events|Total Number of Adverse Events.|up to 20 weeks|||Total Number of AE|||Number
645610|NCT02171234|Secondary|AUC0-τ|"AUC0-τ - Area under the plasma concentration time curve to last measurable time point
Day 1 - pre-dose, 30, 60, 90, 120, 180 minutes, 4, 6, 7, 8, 12, hours post final dose Day 8 - pre-dose, 30, 60, 90, 120, 180 minutes, 4, 6, 7, 8, 12, 24, 36, 48 and 72 hours post final dose"|Day 1 - pre-dose, 30, 60, 90, 120, 180 minutes, 4, 6, 7, 8, 12, hours post final dose Day 8 - pre-dose, 30, 60, 90, 120, 180 minutes, 4, 6, 7, 8, 12, 24, 36, 48 and 72 hours post final dose|||ng.h/ml||Standard Deviation|Mean
645611|NCT02171234|Secondary|Cmax|Cmax - Maximum observed plasma concentration|Day 1 and Day 8|||ng/ml||Standard Error|Mean
645612|NCT02171195|Primary|Total Number of Adverse Events|An adverse event was defined as any undesirable event occurring to a subject during the study, whether or not related to the investigational product|up to 20 weeks|||Number of Adverse Events|||Number
645613|NCT02170779|Secondary|Beck Depression Inventory II (BDI II)|"The BDI-II is a standardized self-report questionnaire to quantify depression.
The BDI-II contains 21 questions, each answer being scored on a scale value of 0 to 3. Answers to 21 questions added together. Higher scores indicate greater depression. Lowest possible score is a 0 whereas highest 63."|at average of 4 months|||units on a scale||Standard Deviation|Mean
645614|NCT02170779|Secondary|Multiple Sclerosis Spasticity Scale - 88 (MSSS-88)|"The modified MSSS-88 is a standardized self-report questionnaire to quantify subject's impact of the effects of spasticity.
The 88 questions each have a possible score of 1-4. All questions are totaled for a final total scores. Higher scores indicate greater spasticity. The lowest score is 88 and the highest possible is 352."|at average of 4 months|||units on a scale||Standard Deviation|Mean
645615|NCT02170779|Secondary|Spasticity Measured by the Modified Ashworth Scale|"The modified Ashworth Scale is a standard clinical and research method to quantify spasticity.
Each of the 6 leg groups is given a scale of 0-4.
0 - Normal. No increase in muscle tone.
- Mild. Barely increased muscle tone. (catch)
- Moderate. Moderately increased muscle tone that can be overcome and full range of motion is possible. (catch and resistance)
- Severe. Severely increased muscle tone that is extremely difficult to overcome and full range of motion is not possible. (resistance and stop)
- Contracted. All groups are summed for a total score for each side of the body. Higher scores indicate greater spasticity. Lowest possible score is a 0 whereas the highest possible score for each side is 24."|at average of 4 months|||units on a scale||Standard Deviation|Mean
645616|NCT02170779|Secondary|Multiple Sclerosis Impact Scale (MSIS-29)|"The MSIS-29 is designed to measure the physical and psychological impact of MS.
Each subscale summed separately. No total calculated. Scores transformed to have a range of 0-100. Lower scores indicate less impact, higher scores indicate higher impact."|at average of 4 months|||units on a scale||Standard Deviation|Mean
645617|NCT02170779|Secondary|Modified Fatigue Impact Scale (MFIS)|This self-report retrospective questionnaire measures fatigue symptoms. It consists of 21 items scored 0-4 for a total score between 0 and 84 and has a coefficient alpha of 0.81. Lower scores on the MFIS indicate less fatigue.|at average of 4 months|||units on a scale||Standard Deviation|Mean
645618|NCT02170779|Secondary|2 Minute Walk Test|The subject walks without assistance of another person for 2 minutes. The distance in feet the individual was able to walk in 2 minutes is then measured.|at average of 4 months|One subject was unable to complete this physical assessment at the visit.||feet||Standard Deviation|Mean
645619|NCT02170779|Secondary|Timed up and go Test|"The Timed Up and Go (TUG) test measures the time in seconds it takes to get up from a chair, walk 10 feet, turn around and return to sit in the chair.
The best score of the two attempts was analyzed."|at average of 4 months|One subject was unable to complete this physical assessment at the visit.||seconds||Standard Deviation|Mean
645620|NCT02170779|Secondary|Timed 25 Foot Walk|"The time to walk 25 feet is strongly related to its ordinal counterpart the Ambulation Index (Spearman r=0.91) without the variability the ordinal scale reflects.
The time is measured and recorded in seconds how long it takes for the participant to walk 25 feet."|at average of 4 months|One subject was unable to complete this physical assessment at the visit.||seconds||Standard Deviation|Mean
645621|NCT02170779|Primary|MS Walking Scale-12 (MSWS-12)|"The MSWS-12 is a clinically validated and reliable tool that is flexible and simple enough to use clinically and in research. It captures patients' perspectives on their ambulatory disability on the following: standing, ability to run, need for support, moving around the home, concentration needed to walk, walking speed, maintaining balance, climbing stairs, walking distance, effort needed to walk, ability to walk, and gait. It is simple to administer and responsive to changes in patient performance over time.
Individual items are scored on a 5 point Likert scale: 1 (Not at all), 2 (A little), 3 (Moderately), 4 (Quite a bit), 5 (Extremely). A total score is generated and reported on a 0 to 100 scale by subtracting the minimum score possible (12) from the patient’s score, dividing by the maximum score possible minus the minimum possible (60-12, or 48), and multiplying. Higher values represent a worse outcome and greater disability."|at average of 4 months|||units on a scale||Standard Deviation|Mean
645622|NCT02170688|Primary|Difference in Enhancement of the Liver and Blood Vessels Over Time, Measured in Hounsfield Units (HU)|Operator-defined regions-of-interest (ROI) will be obtained from liver parenchyma, the portal vein and the abdominal aorta prior to contrast administration and on each slice through the liver post-contrast. Sum of all three areas reported as Summed measurement.|baseline, post-dose imaging (approximately 1hr)|||Hounsfield units (HU)||Standard Deviation|Mean
645623|NCT02170688|Secondary|Difference in Volume of Contrast Used, Measured in Milliliters||baseline, post-dose imaging (approximately 1hr)|||Milliliters||Standard Deviation|Mean
645624|NCT02170662|Secondary|Percent Change in Hair Diameter|The percent change in hair diameter is a recent addition to the methods of assessing efficacy of hair growth promoters. It is a measure of hair mass and does not separate out the effect on terminal and vellus hairs but rather combines the effect on both. Since it is only terminal hairs that contributes to normal hair density, this measure does not add anything to the measures of total, terminal and vellus hair counts in terms of overall effect on hair growth and is therefore not analyzed or reported here.|Baseline to week 17; Week 17 to week 34|Data not analyzed, and therefore not reported.|||||
645625|NCT02170662|Secondary|Percent Change in the Target Area Vellus Hair Count|Vellus hairs are fine hairs that generally do not grow beyond 1 cm and do not contribute to overall hair density. For the most part, they have a diameter of <40 um. They are increased in number in male pattern baldness|Baseline to week 17; and week 17 to week 34|||Percent change of vellus hair count||Full Range|Mean
645626|NCT02170662|Secondary|Percent Change in the Target Area Terminal Hair Count|Terminal hairs are those which grow beyond a cm and contribute to overall hair density.|Baseline to week 17; and week 17 to week 34|||percent change of terminal hair count||Full Range|Mean
645627|NCT02170662|Primary|Percent Change in Target Area Total Hair Count|The primary endpoint is the percent change in total hair count from the beginning and end of each part of the study.|Baseline to week 17; and week 17 to week 34|intention to treat (ITT)||percentage change in total hair count||Full Range|Mean
645628|NCT02170649|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC0-oo)|Area under the plasma concentration versus time curve from time zero to infinity (AUC0-oo) of BIA 2-093|pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 hours post-dose|||ng.h/mL||Standard Deviation|Mean
645629|NCT02170649|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Sampling Time at Which Concentrations Were at or Above the Limit of Quantification (AUC0-t)|Area under the plasma concentration versus time curve from time zero to the last sampling time at which concentrations were at or above the limit of quantification (AUC0-t) of BIA 2-093|pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 hours post-dose|||ng.h/mL||Standard Deviation|Mean
645630|NCT02170649|Secondary|Time of Occurrence of Cmax (Tmax)|Time of occurrence of Cmax of BIA 2-093|pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 hours post-dose|||hours||Full Range|Median
645631|NCT02170649|Primary|Maximum Observed Plasma Concentration (Cmax)|Maximum observed plasma concentration of BIA 2-093|pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 hours post-dose|||ng/mL||Standard Deviation|Mean
645632|NCT02170532|Secondary|Change in Dyspnea Response as Measured by the University of California, San Diego (UCSD) Dyspnea Scale||Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment|Data for this outcome measure is not reported because the data was not collected.|||||
645633|NCT02170532|Secondary|Change in Tremor Assessment Measured by a Scale|Tremor assessment will be made on outstretched hands (0 = none, 1+ = fine tremor, barely perceptible, 2+ = obvious tremor).|Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment|Data for this outcome measure is not reported because the data was not collected.|||||
645634|NCT02170532|Secondary|Change in Heart Rate||Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment|Data for this outcome measure is not reported because the data was not collected.|||||
645636|NCT02170532|Primary|Change in Maximum Forced Expiratory Volume at One Second (FEV1)||Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment|The same 10 subjects received each of the 5 treatments in the same order. Subjects 1-5 were not included in 6 and 8 hour time points.||percentage of change||Standard Deviation|Mean
645637|NCT02170519|Secondary|Change in Mean Venous Oxygen Saturation (SvO2) From Baseline||dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)|Phase 1 subjects||percent change||Standard Deviation|Mean
645638|NCT02170519|Secondary|Change in Mean Venous Oxygen Saturation (SvO2) From Baseline|SvO2 represents an average of all the venous oxygen saturations of the various organs and tissues.|30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours|Phase 2 subjects: 4 subjects did not have a swan ganz catheter. 1 subject had a swan ganz catheter, but measurement was unattainable.||percent change||Standard Deviation|Mean
645639|NCT02170519|Primary|Change in Mean Pulmonary Artery Pressure (mPAP) From Baseline||dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)|Phase 1 subjects||percent change||Standard Deviation|Mean
645640|NCT02170519|Primary|Change in Mean Pulmonary Artery Pressure (mPAP) From Baseline||30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours|Phase 2 subjects: Measurement completed on subjects having a Swan Ganz catheter. 4 subjects did not have a swan ganz catheter.||percent change||Standard Deviation|Mean
645641|NCT02170519|Primary|Number of Treatment Failures|"Treatment failure is defined as Central venous pressure (CVP) ≥ 20 mm Hg and any one of the following:
Cardiac Index (CI) >/= 1.8 L/min/m2
Administration of >/=0.1 ug/kg/min Epinephrine or Norepinephrine
MAP </= 50 mmHg (or as appropriate for age in pediatrics).
SvO2</= 55% (or < 45% for patients with R to L intracardiac shunting and, thus, cyanosis at baseline.}"|as long as subject was on drug up to approximately 24 hours|||participants|||Number
645642|NCT02170519|Secondary|Change in Cardiac Output (CO) From Baseline||dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)|Phase 1 subjects||percent change||Standard Deviation|Mean
645643|NCT02170519|Secondary|Change in Cardiac Output (CO) From Baseline||30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours|Phase 2 subjects: 4 subjects did not have a swan ganz catheter. 1 subject had a swan ganz catheter, but measurement was unattainable.||percent change||Standard Deviation|Mean
645644|NCT02170519|Primary|Change in Mean Heart Rate From Baseline||dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)|Phase 1 subjects||percent change||Standard Deviation|Mean
645645|NCT02170519|Primary|Change in Mean Heart Rate From Baseline||30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours|Phase 2 subjects||percent change||Standard Deviation|Mean
645646|NCT02170519|Primary|Percent Change in Oxygen Saturation (SpO2) From Baseline||dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)|Phase 1 subjects||percent change||Standard Deviation|Mean
645647|NCT02170519|Primary|Percent Change in Oxygen Saturation (SpO2) From Baseline|Readings were taken from the medical record and the data may not have been present at the exact time frames.|30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours|Phase 2 subjects||percent change||Standard Deviation|Mean
645648|NCT02170376|Primary|t1/2 - Terminal Plasma Half-life|t1/2 - Terminal plasma half-life of levodopa (mean pharmacokinetic parameter) following first oral administration of 100/25 mg levodopa/carbidopa on Day 12 with 25, 50 and 75 mg OPC or placebo and 200 mg Entacapone.|pre-first dose and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0 and 5.0 h post-first and -second levodopa/carbidopa administration, and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 8.0 and 14.0 h post-third levodopa/carbidopa administration|||Hours||Standard Deviation|Mean
645649|NCT02170376|Primary|AUC0-5 - AUC Over 5 Hours|AUC0-5 - of levodopa (mean pharmacokinetic parameter) following first oral administration of 100/25 mg levodopa/carbidopa on Day 12 with 25, 50 and 75 mg OPC or placebo and 200 mg Entacapone.|pre-first dose and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0 and 5.0 h post-first and -second levodopa/carbidopa administration, and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 8.0 and 14.0 h post-third levodopa/carbidopa administration|||ng.h/mL||Standard Deviation|Mean
645650|NCT02170376|Primary|AUC0-t - Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Time (t) Corresponding to the Last Quantifiable Concentration.|AUC0-t - of levodopa (mean pharmacokinetic parameter) following first oral administration of 100/25 mg levodopa/carbidopa on Day 12 with 25, 50 and 75 mg OPC or placebo and 200 mg Entacapone.|pre-first dose and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0 and 5.0 h post-first and -second levodopa/carbidopa administration, and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 8.0 and 14.0 h post-third levodopa/carbidopa administration|||ng.h/mL||Standard Deviation|Mean
645651|NCT02170376|Primary|AUC0-∞ - Area Under the Concentration-time Curve From Time Zero up to Infinity With Extrapolation of the Terminal Phase|AUC0-∞ of levodopa (mean pharmacokinetic parameter) following first oral administration of 100/25 mg levodopa/carbidopa on Day 12 with 25, 50 and 75 mg OPC or placebo and 200 mg Entacapone.|pre-first dose and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0 and 5.0 h post-first and -second levodopa/carbidopa administration, and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 8.0 and 14.0 h post-third levodopa/carbidopa administration|||ng.h/mL||Standard Deviation|Mean
645652|NCT02170376|Primary|Tmax - Time of Occurrence of Maximum Plasma Concentration|Tmax - Time to Reach maximum plasma concentration of levodopa (mean pharmacokinetic parameter) following first oral administration of 100/25 mg levodopa/carbidopa on Day 12 with 25, 50 and 75 mg OPC or placebo and 200 mg Entacapone|pre-first dose and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0 and 5.0 h post-first and -second levodopa/carbidopa administration, and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 8.0 and 14.0 h post-third levodopa/carbidopa administration|||hours||Standard Deviation|Mean
645653|NCT02170376|Primary|Cmax - Maximum Plasma Concentration of Levodopa|Cmax - Maximum plasma concentration of levodopa (mean pharmacokinetic parameter) following first oral administration of 100/25 mg levodopa/carbidopa on Day 12 with 25, 50 and 75 mg OPC or placebo and 200 mg Entacapone.|pre-first dose and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0 and 5.0 h post-first and -second levodopa/carbidopa administration, and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 8.0 and 14.0 h post-third levodopa/carbidopa administration|||ng/mL||Standard Deviation|Mean
648288|NCT02106962|Secondary|Local Infection|After using Tranexamic Acid and Bacitracin, local infection rate measured at the end of study|2 months|no local infection in any particioant||participants||Full Range|Mean
645654|NCT02170220|Primary|Cmaxu: Maximum Observed Unbound Plasma Concentration for Vortioxetine|Maximum Observed Unbound Plasma Concentration (Cmaxu) is the peak unbound plasma concentration of a drug after administration, obtained directly from the unbound plasma concentration-time curve.|Predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, and 240 hours postdose|PK Analysis Set included all enrolled participants who received at least 1 dose of study drug with at least 1 measureable plasma concentration.||ng/mL||Standard Deviation|Mean
645655|NCT02170220|Primary|AUC(0-inf)u: Area Under the Unbound Plasma Concentration-time Curve From Time 0 to Infinity for Vortioxetine|AUC(0-inf)u is a measure of total unbound plasma exposure to the drug from time zero extrapolated to infinity.|Predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, and 240 hours postdose|PK Analysis Set included all enrolled participants who received at least 1 dose of study drug with at least 1 measureable plasma concentration.||ng*hr/mL||Standard Deviation|Mean
645656|NCT02170220|Primary|AUC(0-tlqc)u: Area Under the Unbound Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Vortioxetine|AUC(0-tlqc)u is a measure of total unbound plasma exposure to the drug from time 0 to time of the last quantifiable concentration (AUC[0-tlqc]u).|Predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, and 240 hours postdose|PK Analysis Set included all enrolled participants who received at least 1 dose of study drug with at least 1 measureable plasma concentration.||ng*hr/mL||Standard Deviation|Mean
645657|NCT02170220|Primary|Cmax: Maximum Observed Plasma Concentration for Vortioxetine Metabolite Lu AA39835|Maximum Observed Plasma Concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, and 240 hours postdose|PK Analysis Set included all enrolled participants who received at least 1 dose of study drug with at least 1 measureable plasma concentration.||ng/mL||Standard Deviation|Mean
645658|NCT02170220|Primary|Cmax: Maximum Observed Plasma Concentration for Vortioxetine Metabolite Lu AA34443|Maximum Observed Plasma Concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, and 240 hours postdose|PK Analysis Set included all enrolled participants who received at least 1 dose of study drug with at least 1 measureable plasma concentration.||ng/mL||Standard Deviation|Mean
645659|NCT02170220|Primary|Cmax: Maximum Observed Plasma Concentration for Vortioxetine|Maximum Observed Plasma Concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, and 240 hours postdose|PK Analysis Set included all enrolled participants who received at least 1 dose of study drug with at least 1 measureable plasma concentration.||ng/mL||Standard Deviation|Mean
645660|NCT02170220|Primary|AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Vortioxetine Metabolite Lu AA34443|AUC(0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.|Predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, and 240 hours postdose|PK Analysis Set included all enrolled participants who received at least 1 dose of study drug with at least 1 measureable plasma concentration.||ng*hr/mL||Standard Deviation|Mean
645661|NCT02170220|Primary|AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Vortioxetine|AUC(0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.|Predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, and 240 hours postdose|PK Analysis Set included all enrolled participants who received at least 1 dose of study drug with at least 1 measureable plasma concentration.||ng*hr/mL||Standard Deviation|Mean
645662|NCT02170220|Primary|AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Vortioxetine Metabolite Lu AA39835|(AUC(0-tlqc) is a measure of total plasma exposure to the drug from time 0 to time of the last quantifiable concentration (AUC[0-tlqc]).|Predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, and 240 hours postdose|PK Analysis Set included all enrolled participants who received at least 1 dose of study drug with at least 1 measureable plasma concentration.||ng*hr/mL||Standard Deviation|Mean
645663|NCT02170220|Primary|AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Vortioxetine Metabolite Lu AA34443|(AUC(0-tlqc) is a measure of total plasma exposure to the drug from time 0 to time of the last quantifiable concentration (AUC[0-tlqc]).|Predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, and 240 hours postdose|PK Analysis Set included all enrolled participants who received at least 1 dose of study drug with at least 1 measureable plasma concentration.||ng*hr/mL||Standard Deviation|Mean
645664|NCT02170220|Primary|AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Vortioxetine|(AUC(0-tlqc) is a measure of total plasma exposure to the drug from time 0 to time of the last quantifiable concentration (AUC[0-tlqc]).|Predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, and 240 hours postdose|Pharmacokinetic (PK) Analysis Set included all enrolled participants who received at least 1 dose of study drug with at least 1 measureable plasma concentration.||ng*hr/mL||Standard Deviation|Mean
645665|NCT02170207|Secondary|Percentage of Participants With Confirmed Hemostatic Effect Who Experienced Rebleeding After the Completion of Treatment|Rebleeding rate was reported as percentage of participants who experienced rebleeding after confirmed hemostasis by endoscopy and was calculated at 8 weeks after the completion of treatment with lansoprazole. It was calculated by dividing the percentage of the number of participants who experienced rebleeding after hemostasis divided by the total number of participants with confirmed hemostasis.|Week 17 (8 weeks after the last dose of study drug)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.||percentage of participants|||Number
645687|NCT02169453|Primary|AUC0-∞ - Area Under the Plasma Concentration-time Curve Extrapolated to Infinity|AUC0-∞ - Area under the plasma concentration-time curve extrapolated to infinity for levodopa|pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose|||ng.h/mL||Standard Deviation|Mean
645688|NCT02169453|Primary|AUC0-t - Area Under the Plasma Concentration-time Curve to Last Measurable Time Point|AUC0-t - Area under the plasma concentration-time curve to last measurable time point for levodopa|pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose|||ng.h/mL||Standard Deviation|Mean
645666|NCT02170207|Secondary|Percentage of Participants With Confirmed Hemostatic Effect Who Experienced Rebleeding During Treatment|Rebleeding rate was reported as percentage of participants who experienced rebleeding after confirmed hemostasis by endoscopy during treatment with lansoprazole. It was calculated by dividing the percentage of the number of participants who experienced rebleeding after hemostasis divided by the total number of participants with confirmed hemostasis.|Baseline up to Week 9|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.||percentage of participants|||Number
645667|NCT02170207|Secondary|Percentage of Participants With Confirmed Hemostatic Effect|Hemostatic effect was categorized on the basis of degree of improvement as: markedly improved, moderately improved, slightly improved and poor in the participants with confirmed hemostatic effect by endoscopy. Efficacy rate was reported as percentage of participants showing efficacy and was calculated as the sum of percentage of number of participants reporting markedly improved + moderately improved + slightly improved divided by the percentage of total number of participants with confirmed hemostatic effect.|Baseline up to Week 9|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.||percentage of participants|||Number
645668|NCT02170207|Secondary|Percentage of Participants With Observed Hemostatic Effect|Hemostatic effect was categorized on the basis of degree of improvement as: markedly improved, moderately improved, slightly improved and poor in the participants with observed hemostatic effect. Efficacy rate was reported as percentage of participants showing efficacy and was calculated as the sum of percentage of number of participants reporting markedly improved + moderately improved + slightly improved divided by the percentage of total number of participants with observed hemostatic effect.|Baseline up to Week 9|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.||percentage of participants|||Number
645669|NCT02170207|Primary|Number of Participants Reporting One or More Adverse Drug Reactions|Adverse drug reactions are defined as adverse events (AEs) which are in the investigator’s opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.|Baseline up to Week 9|The safety analysis set was defined as all participants who were enrolled and completed the study.||participants|||Number
645670|NCT02170077|Primary|"The Percentage of Participants With a 50% or Greater Reduction in Seizure Frequency (Further Referred to as Responders) in a Treatment Period Compared to the Baseline Period"||baseline, week 12|||percentage of responders|||Number
645671|NCT02170064|Secondary|Percentage Change in Seizure Frequency During Each 4-week Treatment Period Compared to the Baseline Phase|"The efficacy variables were the percentage change in seizure frequency during each 4-week treatment period compared to the baseline phase.
Seizures were recorded in the patient’s diary during the baseline phase and during the following 4-week treatment periods.
Seizure frequency for each patient was standardised to a frequency per 28 days period (i.e., mean daily frequency multiplied by 28). Changes in seizure frequency were analysed for each age group separately."|Baseline, end of 5 mg/kg/day treatment period (4 weeks), 15 mg/kg/day treatment period (4 weeks) and 30 mg/kg/day treatment period (4 weeks).|||percent change||95% Confidence Interval|Median
645672|NCT02170064|Primary|Time of Occurrence of Cmax (Tmax).||pre-dose, and ½, 1½, 3, 4½, 6 and 12 hours post-dose|||hours||Standard Deviation|Mean
645673|NCT02170064|Primary|Maximum Observed Plasma Drug Concentration (Cmax) Post-dose||pre-dose, and ½, 1½, 3, 4½, 6 and 12 hours post-dose|||ng/mL||Standard Deviation|Mean
645674|NCT02169895|Primary|AUC0-t - Area Under the Plasma Concentration-time Curve|AUC0-t - area under the plasma concentration-time curve of benserazide.|pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.|||ng.h/mL||Standard Deviation|Mean
645675|NCT02169895|Primary|Tmax - Time of Occurrence of Cmax|tmax - time of occurrence of Cmax of benserazide|pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose|||hours||Full Range|Median
645676|NCT02169895|Primary|Maximum Observed Plasma Drug Concentration (Cmax)|Cmax - Maximum observed plasma drug concentration of benserazide|pre-dose, 0.5,1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose|||ng/mL||Standard Deviation|Mean
645677|NCT02169479|Primary|AUC0-t - Area Under the Plasma Concentration-time Curve|Area under the plasma concentration-time curve for levodopa|pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose|||ng.h/mL||Standard Deviation|Mean
645678|NCT02169479|Primary|Tmax - Time of Occurrence of Cmax of Levodopa|Tmax - time of occurrence of Cmax of levodopa.|pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose|||hours||Full Range|Median
645679|NCT02169479|Primary|Cmax - Maximum Observed Plasma Concentration of Levodopa|Levodopa maximum observed plasma concentration (Cmax) (ng/mL)|pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose|||ng/mL||Standard Deviation|Mean
645680|NCT02169466|Primary|Tmax - Time to Cmax|Primary pharmacokinetic parameter: tmax - time to Cmax|pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods.||hours||Full Range|Mean
645681|NCT02169466|Primary|AUC0-∞ - AUC From Time Zero to Infinity|Primary pharmacokinetic parameter: Area under the plasma concentration-time curve from time zero to infinity for levodopa|pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods.||ng.h/mL||Standard Deviation|Mean
645682|NCT02169466|Primary|AUC0-t - Area Under the Plasma Concentration-time Curve|Primary pharmacokinetic parameter: Area under the plasma concentration-time curve for levodopa|pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods.||ng.h/mL||Standard Deviation|Mean
645683|NCT02169466|Primary|Cmax - Maximum Observed Plasma Concentration of Levodopa|Primary pharmacokinetic parameter: Levodopa maximum observed plasma concentration (Cmax) (ng/mL)|pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods.||ng/mL||Standard Deviation|Mean
645690|NCT02169440|Primary|AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to Last Observed Concentration (Warfarin + BIA 9-1067)|Mean plasma S-warfarin pharmacokinetic parameters obtained following an oral single dose of 25 mg warfarin co-administered with 25 mg BIA 9-1067|before dose and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 h post- dose.|||ng.h/mL||Standard Deviation|Mean
645691|NCT02169440|Primary|Tmax - Time to Maximum Observed Plasma Concentration (Warfarin + BIA 9-1067)|Mean plasma S-warfarin pharmacokinetic parameters obtained following an oral single dose of 25 mg warfarin co-administered with 25 mg BIA 9-1067|before dose and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 h post- dose.|||hours||Full Range|Median
645692|NCT02169440|Primary|Cmax - Maximum Observed Plasma Concentration (Warfarin + BIA 9-1067)|Mean plasma S-warfarin pharmacokinetic parameters obtained following an oral single dose of 25 mg warfarin co-administered with 25 mg BIA 9-1067|before dose and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 h post- dose.|||ng/mL||Standard Deviation|Mean
645693|NCT02169440|Primary|AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to Last Observed Concentration (Warfarin Alone)|Mean plasma S-warfarin pharmacokinetic parameters obtained following an oral singledose of 25 mg warfarin administered alone|before dose and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 h post- dose.|||ng.h/mL||Standard Deviation|Mean
645694|NCT02169440|Primary|Tmax - Time to Maximum Observed Plasma Concentration (Warfarin Alone)|Mean plasma S-warfarin pharmacokinetic parameters obtained following an oral singledose of 25 mg warfarin administered alone|before dose and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 h post- dose.|||hours||Full Range|Median
645695|NCT02169440|Primary|Cmax = Maximum Plasma Concentration (Warfarin Alone)|Mean plasma S-warfarin pharmacokinetic parameters obtained following an oral singledose of 25 mg warfarin administered alone|before dose and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 h post- dose.|||ng/mL||Standard Deviation|Mean
645696|NCT02169440|Primary|AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to Last Observed Concentration (BIA 9-1067 + Warfarin)|Mean plasma BIA 9-1067 pharmacokinetic parameters obtained following an oral single dose of 25 mg warfarin co-administered with 25 mg BIA 9-1067|before dose and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 h post- dose.|||ng.h/mL||Standard Deviation|Mean
645697|NCT02169440|Primary|Tmax - Time to Maximum Observed Plasma Concentration (BIA 9-1067 + Warfarin)|Mean plasma BIA 9-1067 pharmacokinetic parameters obtained following an oral single dose of 25 mg warfarin co-administered with 25 mg BIA 9-1067|before dose and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 h post- dose.|||hours||Full Range|Median
645698|NCT02169440|Primary|Cmax - Maximum Observed Plasma Concentration (BIA 9-1067 + Warfarin)|Mean plasma BIA 9-1067 pharmacokinetic parameters obtained following an oral single dose of 25 mg warfarin co-administered with 25 mg BIA 9-1067|before dose and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 h post- dose.|||ng/mL||Standard Deviation|Mean
645699|NCT02169427|Secondary|Tmax - Time to Attain Maximum Concentration|BIA 9-1103 is a Opicapone (OPC, BIA 9-1067) metabolite|pre-dose and 0-6, 6-12, 12-24, 24-48, 48 72, 72-96, 96 120, 120-144, 144-168, 168-192, 192-216 and 216-240 hours post-dose; 24-hour collections on Days 14/15, 21/22, 28/29|||hours||Standard Deviation|Mean
645700|NCT02169427|Secondary|Cmax - Maximum Concentration|BIA 9-1103 is a Opicapone (OPC, BIA 9-1067) metabolite|pre-dose and 0-6, 6-12, 12-24, 24-48, 48 72, 72-96, 96 120, 120-144, 144-168, 168-192, 192-216 and 216-240 hours post-dose; 24-hour collections on Days 14/15, 21/22, 28/29|||ng [eq]/mL||Standard Deviation|Mean
645701|NCT02169427|Primary|Cumulative Recovery of [14C]-Radioactivity|"AEurine: Cumulative Recovery of [14C]-Radioactivity in urine AEfaeces: Cumulative Recovery of [14C]-Radioactivity in urine AEair: Cumulative Recovery of [14C]-Radioactivity in urine AEtotal: Cumulative Recovery of [14C]-Radioactivity in urine
Recovery % of dose has been derived from area under the excretion rate (to infinity) from 240h onwards"|pre-dose and 0-6, 6-12, 12-24, 24-48, 48 72, 72-96, 96 120, 120-144, 144-168, 168-192, 192-216 and 216-240 hours post-dose; 24-hour collections on Days 14/15, 21/22, 28/29|||Recovery % of dose||Standard Deviation|Mean
645702|NCT02169414|Primary|AUC0-t - Area Under the Plasma Concentration-time Curve (AUC) of Levodopa From Time Zero to the Last Sampling Time at Which the Drug Concentration Was at or Above the Lower Limit of Quantification. (Levodopa/Benserazide)|Levodopa pharmacokinetic parameters following a single oral administration of 100/25 mg levodopa/benserazide administered 12 h after BIA 9-1067 (5 mg, 15 mg and 50 mg) or placebo on Day 18|pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose|||ng.h/mL||Standard Deviation|Mean
645703|NCT02169414|Primary|AUC0-∞ - Area Under the Plasma Concentration-time Curve (AUC) of Levodopa From Time Zero to Infinity (Levodopa/Benserazide)|Levodopa pharmacokinetic parameters following a single oral administration of 100/25 mg levodopa/benserazide administered 12 h after BIA 9-1067 (5 mg, 15 mg and 50 mg) or placebo on Day 18|pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose.|||ng.h/mL||Standard Deviation|Mean
645704|NCT02169414|Primary|Tmax - Time to Reach Maximum Plasma Concentration of Levodopa (Levodopa/Benserazide)|Levodopa pharmacokinetic parameters following a single oral administration of 100/25 mg levodopa/benserazide administered 12 h after BIA 9-1067 (5 mg, 15 mg and 50 mg) or placebo on Day 18|pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose.|||hours||Standard Deviation|Mean
645705|NCT02169414|Primary|Cmax - Maximum Plasma Concentration of Levodopa (Levodopa/Benserazide )|Levodopa pharmacokinetic parameters following a single oral administration of 100/25 mg levodopa/benserazide administered 12 h after BIA 9-1067 (5 mg, 15 mg and 50 mg) or placebo on Day 18|pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose.|||ng/mL||Standard Deviation|Mean
645706|NCT02169414|Primary|AUC0-t - Area Under the Plasma Concentration-time Curve (AUC) of Levodopa From Time Zero to the Last Sampling Time at Which the Drug Concentration Was at or Above the Lower Limit of Quantification. (Levodopa/Carbidopa)|AUC0-t - Area under the plasma concentration-time curve (AUC) of levodopa from time zero to the last sampling time following a single oral administration of 100/25 mg levodopa/carbidopa administered 12 h after BIA 9-1067 (5 mg, 15 mg and 50 mg) or placebo on Day 11|pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose.|||ng.h/mL||Standard Deviation|Mean
648447|NCT02103114|Secondary|Total Dose of Recombinant Factor 7a (VIIa) Used Intraoperatively|Total Dose of rescue recombinant factor 7a (VIIa) used intraoperatively|Intraoperatively|||mcg||Standard Deviation|Mean
645707|NCT02169414|Primary|AUC0-∞ - Area Under the Plasma Concentration-time Curve (AUC) of Levodopa From Time Zero to Infinity (Levodopa/Carbidopa)|Levodopa pharmacokinetic parameters following a single oral administration of 100/25 mg levodopa/carbidopa administered 12 h after BIA 9-1067 (5 mg, 15 mg and 50 mg) or placebo on Day 11|pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose.|||ng.h/mL||Standard Deviation|Mean
645708|NCT02169414|Primary|Tmax - Time to Reach Maximum Plasma Concentration of Levodopa (Levodopa/Carbidopa)|Tmax - Time to Reach maximum plasma concentration of levodopa following a single oral administration of 100/25 mg levodopa/carbidopa administered 12 h after BIA 9-1067 (5 mg, 15 mg and 50 mg) or placebo on Day 11|pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose.|||hours||Standard Deviation|Median
645709|NCT02169414|Primary|Cmax - Maximum Plasma Concentration of Levodopa (Levodopa/Carbidopa)|Cmax - Maximum plasma concentration of levodopa following a single oral administration of 100/25 mg levodopa/carbidopa administered 12 h after BIA 9-1067 (5 mg, 15 mg and 50 mg) or placebo on Day 11|pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose.|||ng/mL||Standard Deviation|Mean
645710|NCT02169336|Primary|Summed Pain Intensity Difference Over the First 48 Hours (SPID48).|Pain intensity was recorded using a Numeric Rating Scale (Range 0-10) where 0 equates to no pain, and 10 equates to the worst pain imaginable. Pain intensity scores were to be recorded at the following time points: 0.25, 0.5, 0.75, 1, 2, 4, and 6 hours post Dose 1. Thereafter pain assessments were to be recorded every 2 hours until 48 hours. Pain intensity differences from baseline at each time point were calculated and a time weighted SPID was then calculated. Time weighted SPID calculations were computed by multiplying a weight factor to each score prior to summation. The weight factor at each time point was the time elapsed since the previous observation.|48 hours|||units on a scale||Standard Deviation|Mean
645711|NCT02169115|Secondary|To Assess the Safety of Omalizumab in UF Patients|Safety of patients treated with omalizumab: This includes physical examination, routine safety laboratory assessments, vital signs and adverse event reporting|112 days||||||
645712|NCT02169115|Secondary|To Assess Long-term Effects of Omalizumab in UF Patients|To assess long-term effects of omalizumab in UF patients, change in friction thresholds from day 70 (week 10) to day 112 (week 16) will be assessed|112 days||||||
645713|NCT02169115|Secondary|To Assess the Effects of Omalizumab in UF Patients on Patient Global Assessment of Disease Severity|Change in patient global assessment of disease severity assessed by visual analogue scale by the patient from baseline to day 70 after treatment with omalizumab compared to placebo.|70 days||||||
645714|NCT02169115|Secondary|To Assess the Effects of Omalizumab in UF Patients on Physician Global Assessment of Disease Severity|Change in physician global assessment of disease severity assessed by visual analogue scale by a physician from baseline to day 70 after treatment with omalizumab compared to placebo.|70 days||||||
645715|NCT02169115|Secondary|To Assess the Effects of Omalizumab in UF Patients on Number of Symptom Free Days|Change in number of symptom free days as assessed by a patient diary from baseline to day 70 after treatment with omalizumab compared to placebo|70 days||||||
645716|NCT02169115|Secondary|To Assess the Effects of Omalizumab in Urticaria Factitia Patients on Quality of Life|Change in quality of life scores assessed by Dermatology Life Quality Index (DLQI) and UF specific life quality questions from baseline to day 70 after treatment with omalizumab compared to placebo.|70 days||||||
645717|NCT02169115|Primary|Change in Provocation Thresholds From Baseline to Day 70 in Urticaria Factitia Patients After Treatment With Omalizumab Compared to Placebo|Patients receive provocation test by FricTest (standardized stroking of the skin). FricTest ratings are from 0 (no wheal development to the longest pin) to 4 (wheal development to all four pins). The development of wheals within 30 minutes after provocation is monitored.|70 days|||wheal development up to four pins||Standard Deviation|Mean
645718|NCT02168491|Secondary|Change in Body Weight From Baseline to End of Study|A change between two time points is reported. Time Frame: baseline and 12 weeks.|12 weeks|||weight in kg||Standard Deviation|Mean
645719|NCT02168491|Secondary|Change in Fasting Plasma Glucose (FPG, Mean Over 2 Weeks)|"Patients will be instructed to record all insulin injections and a complete 7-point-blood glucose profile (fasting, 2h after breakfast, before lunch, 2h after lunch, before dinner, 2h after dinner, late before going to bed) during a one-week prestudy run-in period to confirm compliance and document current metabolic control and doses of premixed insulin.
Patients will be asked to record not only glucose profiles (at least 4 measurements per day) but also the occurrence of hypoglycemic symptoms or other adverse effects daily throughout the study.
During the last week of the study patients will be asked to again record a complete 7-point-blood glucose profile (fasting, 2h after breakfast, before lunch, 2h after lunch, before dinner, 2h after dinner, late before going to bed) and drug injections to confirm compliance and document metabolic control."|12 weeks|||glucose in mg/dl||95% Confidence Interval|Mean
645720|NCT02168491|Primary|Change in HbA1c From Baseline to End|A change between two time points is reported. Time Frame: baseline and 12 weeks.|12 weeks|||HbA1c in percent||Standard Deviation|Mean
645721|NCT02168478|Primary|Evidence of Pre-Existing Sensitization by Use of the Erythemal Scoring Scale (ESS)|"ESS is measured at 48, 96 and 168 hours post-application of study material. The Erythemal Scoring Scale (ESS) is defined as a 6 point scale (0-4). 0= no visible erythema; 0.5= slight, barely perceptible erythema; 1= mild erythema; 2= moderate erythema; 3= marked erythema; 4= severe erythema. An ESS score of 1 or greater that persists or worsens from one visit to the next is defined as pre-existing sensitization."|48, 96 and 168 Hours|||percentage of patients w allergic rxn|||Number
645722|NCT02168439|Other Pre-specified|Anxiolysis Satisfaction|"Likert scale parent, child life and proceduralist survey
5 point likert scale asking how satisfied the parent or proceduralist is with the anxiolysis from the medication.
1 being not satisfied at all, 3 neutral, 5 very satisfied."|Day 1|||units on a scale||Standard Deviation|Median
645723|NCT02168439|Other Pre-specified|Need for Procedural Sedation|Whether the patient required procedural sedation for completion of the procedure|Day 1|||percentage of participants|||Number
645724|NCT02168439|Other Pre-specified|Procedure Completion|note of whether the procedure was able to be completed|Day 1|||percentage of participants|||Number
645791|NCT02165111|Secondary|Number of Ulcers as Measure of Digital Ulcer Healing|A secondary outcome of this study is the number of digital ulcers as determined by clinical examination. Mean number of ulcers was calculated as total number of ulcers / total number of hands in each group.|Measured at one month post-injection.|||Number of ulcers||Standard Deviation|Mean
645725|NCT02168439|Secondary|VAS for Anxiety as Completed by Caregiver and Observer|"VAS, Visual Analog Scale for anxiety. Scale from 0-10 written on a 10 cm horizontal line with the extremes labeled as no anxiety to very anxious.
Vertical line is drawn on the scale at the level of anxiety. The distance was measured.
Higher numbers equal higher anxiety."|Day 1|||units on a scale||Standard Deviation|Mean
645726|NCT02168439|Secondary|mYPAS Scores at Other Time Points|mYPAS stands for modified Yale Preoperative anxiety scale. The scale is from minimum 23.3- maximum 100. Higher scores indicate higher anxiety. By prior characterization, scores less than or equal to 30 are classified as not anxious.|Day 1|||units on a scale||95% Confidence Interval|Median
645727|NCT02168439|Primary|mYPAS Score as Completed by Researchers to Assess Anxiety|"Primary outcome was the mYPAS scores at the time of positioning for procedure.
mYPAS stands for modified Yale Preoperative anxiety scale. The scale is from minimum 23.3- maximum 100. Higher scores indicate higher anxiety. By prior characterization, scores less than or equal to 30 are classified as not anxious."|Day 1|||units on a scale||95% Confidence Interval|Median
645728|NCT02168387|Secondary|Change in Quantity and Quality of Suctioned Mucus||baseline and 48 hours|These data were not obtained due to technical difficulties.|||||
645729|NCT02168387|Secondary|Change in Capnography (Vd/Vt)|The deadspace-to-tidal volume (Vd/Vt) ratio is a parameter that is measured in mechanically ventilated patients as a way to assess the severity of gas exchange impairment and to assist in determining whether a patient is ready to be weaned from the ventilator. The change from baseline was measured at 48 hours, with a decreasing ratio indicating improvement.|baseline and 48 hours|||ratio||Standard Deviation|Mean
645730|NCT02168387|Primary|Improvement of Atelectasis|"An atelectasis score (AS), as published by Deakins, et al. 2002, was assigned to each radiograph as follows:
0 Complete resolution of collapse
Partial collapse of 1 segment or lobe
Partial collapse of ≥ 2 segments or lobes
Complete collapse of 1 segment or lobe
Complete collapse of ≥ 2 segments or lobes
In the event of inter-rater disagreement, the scores were averaged. Improvement was defined as any decrease in AS ≥ 0.5. Worsening was defined as an increase in AS ≥ 0.5 or escalation of respiratory support modality (i.e. high frequency ventilation)."|after 48 hours of therapy|||participants|||Number
645731|NCT02168361|Secondary|Serum HCV RNA Level||4 and 12 weeks into therapy|All participants that received at least a single dose of medication||IU/ml||Full Range|Median
645732|NCT02168361|Primary|Proportion of Participants With Sustained Virologic Response 12 (SVR-12)|Undetectable virus (sensitive nucleic acid test) in Serum at 3 months post-therapy|12 weeks post-therapy|All participants that received at least a single dose of medication||participants|||Number
645733|NCT02167893|Secondary|Percentage of Participants With Disease-specific Survival|Disease-specific survival is defined as time interval between the date of randomization and the earliest date of local, regional or distant relapse, or death due to cancer.|Baseline up to 96 weeks|No results have been reported in this measure because as predefined in the protocol, the outcome measure was not planned to be assessed.|||||
645734|NCT02167893|Secondary|Percentage of Participants With Metastasis-free Survival||Baseline up to 96 weeks|No results have been reported in this measure because as predefined in the protocol, the outcome measure was not planned to be assessed.|||||
645735|NCT02167893|Secondary|Percentage of Participants With Overall Survival (OS) Based on TNM Classification|OS was defined as the duration from randomization to death (due to any cause). Probability of OS was reported using Kaplan-Meier method. TNM classification based on tumor size, if cancer cells had spread to nearby lymph nodes (LN), or distant metastasis. Stages included: stage 0(no evidence of cancer cells),stage 1(T1N0M0), stage IIA(T0N1M0, T1N1M0, T2N0M0), stage IIB(T2N1M0, T3N0M0), stage IIIA(T0N2M0, T1N2M0, T2N3M0, T3N1orN2M0),stage IIIb( T4 anyNM0, any TN3M0),stage IIIC(any TN3M0), stage IV(any T any NM1), where T0=early form of tumor, T1=<2 centimeter (cm), T2=2-5 cm, T3=>2 cm, T4=large sized, N0=not spread to LN, N1=spread to 1 to 3,N2=spread to 4 to 9,N3=spread >10 axillary LN, M0=no metastasis, M1= Metastasis.|Baseline up to 96 weeks or death (which ever occurs first)|The efficacy assessment population was defined as all participants whose efficacy data at baseline and at least 1 post-baseline time points was available.||percentage of participants||95% Confidence Interval|Number
645736|NCT02167893|Secondary|Percentage of Participants With Progression Free Survival (PFS) Based on TNM Classification|PFS was defined as the time from the first day of study treatment to documented disease progression or death on study. For participants who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate PFS. TNM classification based on tumor size, if cancer cells had spread to nearby lymph nodes (LN), or distant metastasis. Stages included: stage 0(no evidence of cancer cells),stage 1(T1N0M0), stage IIA(T0N1M0, T1N1M0, T2N0M0), stage IIB(T2N1M0, T3N0M0), stage IIIA(T0N2M0, T1N2M0, T2N3M0, T3N1orN2M0),stage IIIb( T4 anyNM0, any TN3M0),stage IIIC(any TN3M0), stage IV(any T any NM1), where T0=early form of tumor, T1=<2 centimeter (cm), T2=2-5 cm, T3=>2 cm, T4=large sized, N0=not spread to LN, N1=spread to 1 to 3,N2=spread to 4 to 9,N3=spread >10 axillary LN, M0=no metastasis, M1= Metastasis.|Baseline up to 96 weeks|The efficacy assessment population was defined as all participants whose efficacy data at baseline and at least 1 post-baseline time points was available.||percentage of participants||95% Confidence Interval|Number
645737|NCT02167893|Primary|Number of Participants Reporting One or More Serious Adverse Drug Reactions|Serious adverse drug reactions are defined as serious adverse events (SAE) which are in the investigator’s opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to Week 96|The safety analysis set was defined as all participants who were enrolled and completed the study.||participants|||Number
645738|NCT02167893|Primary|Number of Participants Reporting One or More Adverse Drug Reactions|Adverse drug reactions are defined as adverse events (AEs) which are in the investigator’s opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.|Baseline up to Week 96|The safety analysis set was defined as all participants who were enrolled and completed the study.||participants|||Number
646308|NCT02150044|Primary|Ear Outcome Success|Ear Outcome Success is successful delivery of the tympanostomy tube (TT) across the tympanic membrane (TM) per ear. This endpoint was evaluated for the 13 study cohort subjects only (not the 16 lead-in subjects).|Day 0 (at procedure visit)|||ears|Participants||Number
645739|NCT02167867|Primary|Average Change in Inches of Total Circumference Measurements for the Treatment Subject Group After 2 Weeks of Treatment With the ZERONA Z6|Circumference in inches for the waist, hips and both thighs were measured and added together to give a total circumference measurement at baseline and at the end of the 2 weeks of treatment. The change in the total circumference measurement from baseline to the end of treatment was calculated. A decrease (-) in circumference measurement suggests study success and an increase (+) in circumference measurement suggests study failure. A decrease (-) of 3.52 inches (-3.52 inches) or more is positive for study success based on prior published results.|Baseline and 2 weeks|||inches||Standard Deviation|Mean
645740|NCT02167867|Primary|Lay End User Ability to Correctly Use the ZERONA Z6 and Follow the Treatment Directions.|The number of lay end users who correctly used the ZERONA Z6 to administer treatments by following the treatment administration protocol was calculated|two weeks|||participants|||Number
645741|NCT02167867|Primary|Lay End User Ability to Correctly Choose Suitably Qualified Individuals to Get the ZERONA Z6 Treatments|The number of lay end users who correctly evaluated and selected fully qualified individuals to get the ZERONA Z6 treatment was calculated.|Baseline|||participants|||Number
645742|NCT02167815|Secondary|Measure of Actual Dressing Cost and Cost of Care, as Input for Health Economics Calculations.||16 weeks|the way to collect data differed to much betwen the sites, no analysis could be done.|||||
645743|NCT02167815|Secondary|Users Feedback After Handling or Use as a Measure of Performance.|"Investigator/Nurse and Subject evaluation of performance of the primary dressing ( n) Scale= Good , Very Good, Poor, Very Poor
1Ease of application, 2 Ease of removal, 3 Ability to retain exudate, 4 Adherence to healthy skin, 5 Confomability to be repositioned , 6 Overall satisfaction, 7 Dressing sticking to wound bed, 8 Presence of residues on the wound bed. 9 Presence of residues on the healthy skin. 10 Overall evaluation of change in periwound skin condition."|16 weeks|||participants|||Number
645744|NCT02167815|Secondary|Pain Scores on the Visual Analog Scale|Pain at baseline visit, compared with pain at week 16. VAS scale, minimum pain = 0, maximum pain = 100.|16 weeks|||units on a scale (VAS)||Standard Deviation|Mean
645745|NCT02167815|Primary|Changes From Baseline in Condition of the Peri Wound Skin|Deteriorationin of skin condition , Mepilex XT and Standard care (%)|16 weeks|Intention to treat, change from baseline in condition of the peri-wound skin.||percentage of subjects|||Number
645746|NCT02167139|Secondary|Disease Activity Score Based on a 28 Joint Count (DAS28)||Week 24, Week 52||||||
645747|NCT02167139|Secondary|American College of Rheumatology 50% Response Criteria (ACR50)||Week 24, Week 52|||percentage of participants|||Number
645748|NCT02167139|Secondary|ACR20||Week 52|||percentage of participants|||Number
645749|NCT02167139|Primary|American College of Rheumatology 20% Response Criteria (ACR20)||Week 24|||percentage of participants|||Number
645750|NCT02166697|Secondary|Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity + Blood Glucose Abnormalities + Lipid Abnormalities|Participants reporting cerebrovascular/cardiovascular events who had obesity, blood glucose and lipid abnormalities associated with Blopress at the time of enrollment were reported. The composite events classified under primary MACE1 and primary MACE2 were defined as: MACE1: sudden death, cerebral hemorrhage, cerebral infarction, subarachnoid hemorrhage, and acute myocardial infarction; MACE2: MACE1 + hospitalization for cardiac failure and intervention/hospitalization for angina pectoris. Renal events include (transition to dialysis + renal transplant).|Baseline up to 3 years|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.||Number of events/1,000 person-years|||Number
645751|NCT02166697|Secondary|Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity + Blood Glucose Abnormalities, Obesity + Lipid Abnormalities, or Blood Glucose Abnormalities + Lipid Abnormalities|Participants reporting cerebrovascular/cardiovascular events who had multiple underlying risk factors which included either obesity + blood glucose abnormalities, obesity + lipid abnormalities OR blood glucose + lipid abnormalities associated with Blopress at the time of enrollment were reported. The composite events classified under primary MACE1 and primary MACE2 were defined as: MACE1: sudden death, cerebral hemorrhage, cerebral infarction, subarachnoid hemorrhage, and acute myocardial infarction; MACE2: MACE1 + hospitalization for cardiac failure and intervention/hospitalization for angina pectoris. Renal events include (transition to dialysis + renal transplant).|Baseline up to 3 years|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.||Number of events/1,000 person-years|||Number
645752|NCT02166697|Secondary|Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity, Blood Glucose Abnormalities, or Lipid Abnormalities|Participants reporting cerebrovascular/cardiovascular events who had either obesity, blood glucose abnormalities, or lipid abnormalities as any one of the underlying risk factors associated with Blopress at the time of enrollment were reported.The composite events classified under primary MACE1 and primary MACE2 were defined as: MACE1: sudden death, cerebral hemorrhage, cerebral infarction, subarachnoid hemorrhage, and acute myocardial infarction; MACE2: MACE1 + hospitalization for cardiac failure and intervention/hospitalization for angina pectoris. Renal events include (transition to dialysis + renal transplant).|Baseline up to 3 years|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.||Number of events/1,000 person-years|||Number
645753|NCT02166697|Secondary|Incidence of Cerebrovascular/Cardiovascular Events|Cerebrovascular/cardiovascular events reported to be associated with Blopress were reported. The composite events classified under primary major adverse cardiac Events (MACE) 1 and primary MACE2 were defined as: MACE1: sudden death, cerebral hemorrhage, cerebral infarction, subarachnoid hemorrhage, and acute myocardial infarction; MACE2: MACE1 + hospitalization for cardiac failure and intervention/hospitalization for angina pectoris. Renal events include (transition to dialysis + renal transplant).|Baseline up to 3 years|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.||Number of events per 1,000 person-years|||Number
645817|NCT02163915|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-137|Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.|Days 1 and 7 pre-dose and at multiple timepoints (up to 24 hours) post-dose|Pharmacokinetic analysis set was defined as all participants who received at least one dose of study drug and had at least one measurable plasma concentration.||hours||Full Range|Median
645754|NCT02166697|Primary|Number of Participants Reporting One or More Serious Adverse Drug Reactions (SADR)|SADR are defined as serious adverse events (SAEs) which are in the investigator’s opinion of causal relationship to the study treatment. SADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to 3 years|The safety analysis set was defined as all participants who were enrolled and completed the study.||Participants|||Number
645755|NCT02166697|Primary|Number of Participants Reporting One or More Adverse Drug Reactions (ADR)|ADR are defined as adverse events (AEs) which are in the investigator’s opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.|Baseline up to 3 years|The safety analysis set was defined as all participants who were enrolled and completed the study.||Participants|||Number
645756|NCT02165826|Secondary|Median Simulated Absolute Change From Baseline in FEV1 at Weeks 4 and 12|The PK model predicted the total PDE4 inhibitory activity and the median simulated Change from Baseline (CFB) in FEV1 at Week 4 and the Change from Baseline in FEV1 at Week 12 during 12 weeks of treatment with roflumilast 500 μg OD based on 1000 participants simulated. Results are reported for the set of reference participants defined according to the covariates [weight, smoking status, sex, age, race, COPD severity, concomitant long acting muscarinic antagonist (LAMA) and Percent FEV1 reversibility] included in the final model and tPDE4i. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Pulmonary function testing was performed using spirometry prior to taking study medication. A positive change from Baseline indicates improvement.|Main period: Pre-dose and 1,2,3,4,6 hours post-dose or pre-dose and 2 hours post-dose at Days 15 and 57. FEV-1: Pre-dose and Weeks 4 and 12|Pharmacokinetic (PK) Set included all participants who had at least 1 quantifiable PK concentration. The number of participants analyzed is the number of participants simulated. Measured values are predicted values.||milliliters (mL)|||Number
645757|NCT02165826|Secondary|Median Simulated Percentage of Participants With Adverse Events of Interest|The PK model predicted the total PDE4 inhibitory activity and the median simulated percentage of participants with Adverse Events of Interest during 12 weeks of treatment based on 1000 participants simulated. Results are reported for the set of reference participants defined according to the covariates [weight, smoking status, sex, age and long acting muscarinic antagonist (LAMA)] included in the final model and tPDE4i. Adverse Events of Interest (AEI) for PK analyses included: headache, diarrhea, nausea, vomiting, abdominal pain, appetite disorders, sleep disorders, angioedema, psychiatric disorders (anxiety, nervousness), psychiatric disorders (depression, suicidal ideation, behaviour) and weight loss.|Main period: Pre-dose and 1,2,3,4,6 hours post-dose or pre-dose and 2 hours post-dose at Days 15 and 57. AEIs: 12 Weeks|Pharmacokinetic (PK) Set included all participants who had at least 1 quantifiable PK concentration. Number of participants analyzed is the number of participants simulated. Measured values are predicted values.||percentage of participants|||Number
645758|NCT02165826|Secondary|Summary Statistics of Predicted Total PDE4 Inhibitory Activity (tPDE4i)|tPDE4i was derived using in-vitro constants for protein binding and biochemical activity (IC50). An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. Adverse Events of Interest (AEI) for PK analyses included: headache, diarrhea, nausea, vomiting, abdominal pain, appetite disorders, sleep disorders, angioedema, psychiatric disorders (anxiety, nervousness), psychiatric disorders (depression,suicidal ideation,behaviour) and weight loss.|Main period: Pre-dose and 1,2,3,4,6 hours post-dose or pre-dose and 2 hours post-dose at Days 15 and 57. Down-titration: Pre-dose and 1,2,3,4,6 hours post-dose at Days 1 and 14 and pre-dose at Days 28 and 56.|"PK Set included all participants who had at least 1 quantifiable PK concentration. n in the category is the number of participants with available data. Study design only includes the 250 µg OD and 500 µg OD arms for analyses of this outcome measure. Measured values are predicted values reported as median and 90% prediction interval."||unitless||90% Confidence Interval|Median
645759|NCT02165826|Secondary|Total PDE4 Inhibitory Activity (tPDE4i)|tPDE4i was derived using in-vitro constants for protein binding and biochemical activity (IC50). tPDE4i is reported for a set of reference participants defined according to the covariates included in the final model.|Main period: Pre-dose and 1,2,3,4,6 hours post-dose or pre-dose and 2 hours post-dose at Days 15 and 57. Down-titration: Pre-dose and 1,2,3,4,6 hours post-dose at Days 1 and 14 and pre-dose at Days 28 and 56.|Participants from the PK Set, all participants who had at least 1 quantifiable PK concentration, with data available. Study design only includes the 250 µg arm for analyses of this outcome measure in the Down-Titration period. Measured values are predicted values reported as median and 90% prediction interval.||unitless||90% Confidence Interval|Median
645760|NCT02165826|Secondary|Population PK Model Point Estimate for Apparent Peripheral Volume (Vp/F) of Roflumilast and Roflumilast N-oxide|PK model point estimates for Vp/F are calculated using all available PK data for all doses of roflumilast combined and are presented for roflumilast and metabolite roflumilast N-oxide. Results are reported for the subgroups defined according to the covariates (weight, age, smoking status and sex) included in the final model.|Main period: Pre-dose and 1,2,3,4,6 hours post-dose or pre-dose and 2 hours at weeks 2 or 8|Pharmacokinetic (PK) Set included all participants who had at least 1 quantifiable PK concentration.||L|||Number
645761|NCT02165826|Secondary|Population PK Model Point Estimate for Apparent Central Volume (Vc/F) of Roflumilast and Roflumilast N-oxide|PK model point estimates for Vc/F are calculated using all available PK data for all doses of roflumilast combined and are presented for roflumilast and metabolite roflumilast N-oxide. Results are reported for the subgroups defined according to the covariates (weight, age, smoking status and sex) included in the final model.|Main period: Pre-dose and 1,2,3,4,6 hours post-dose or pre-dose and 2 hours at weeks 2 or 8|Pharmacokinetic (PK) Set included all participants who had at least 1 quantifiable PK concentration.||liters (L)|||Number
645818|NCT02163915|Secondary|Cmax, ss: Maximum Observed Plasma Concentration at Steady State for TAK-137|Maximum observed steady-state plasma concentration during a dosing interval.|Day 7 pre-dose and at multiple timepoints (up to 24 hours) post-dose|Pharmacokinetic analysis set was defined as all participants who received at least one dose of study drug and had at least one measurable plasma concentration.||ng/mL||Standard Deviation|Mean
645762|NCT02165826|Secondary|Population PK Model Point Estimate for Apparent Oral Clearance (CL/F) of Roflumilast and Roflumilast N-oxide|PK model point estimates for CL/F are calculated using all available PK data for all doses of roflumilast combined and are presented for roflumilast and metabolite roflumilast N-oxide. Results are reported for the subgroups defined according to the covariates (weight, age, smoking status and sex) included in the final model.|Main period: Pre-dose and 1,2,3,4,6 hours post-dose or pre-dose and 2 hours at weeks 2 or 8|Pharmacokinetic (PK) Set included all participants who had at least 1 quantifiable PK concentration.||liters per hour (L/h)|||Number
645763|NCT02165826|Secondary|Population PK Model Point Estimate for Absorption Rate Constant (Ka) of Roflumilast and Roflumilast N-oxide|PK model point estimates for Ka are calculated using all available PK data for all doses of roflumilast combined and are presented for roflumilast and metabolite roflumilast N-oxide. Results are reported for the subgroups defined according to the covariates (weight, age, smoking status and sex) included in the final model.|Main period: Pre-dose and 1,2,3,4,6 hours post-dose or pre-dose and 2 hours at weeks 2 or 8|Pharmacokinetic (PK) Set included all participants who had at least 1 quantifiable PK concentration.||units per hour (1/h)|||Number
645764|NCT02165826|Secondary|Change From Baseline in Treatment Satisfaction Scores During the Down-Titration Period|Participants will be asked to assess their satisfaction with their COPD therapy at each visit. The participants will rate their treatment satisfaction on a 7-point scale where 0=very satisfied, 1=satisfied, 2=somewhat satisfied, 3=neither satisfied nor dissatisfied, 4=somewhat dissatisfied, 5=dissatisfied and 6=very dissatisfied. A negative change from Baseline indicates improvement.|Baseline DT (Day 1 of Down-Titration Period) to Days 14, 28 and 56 (Down-Titration Period)|"Down-Titration Period Full Analysis Set (FAS) included all randomized participants who entered this period, regardless of whether they took study medication. n in each of the categories is the number of participants with data available at the given time-point."||score on a scale||Standard Deviation|Mean
645765|NCT02165826|Secondary|Change From Baseline in Treatment Satisfaction Scores During the Main Period|Participants will be asked to assess their satisfaction with their COPD therapy at each visit. The participants will rate their treatment satisfaction on a 7-point scale where 0=very satisfied, 1=satisfied, 2=somewhat satisfied, 3=neither satisfied nor dissatisfied, 4=somewhat dissatisfied, 5=dissatisfied and 6=very dissatisfied. A negative change from Baseline indicates improvement.|Baseline (Day 1 of Main Period) to Days 15, 29, 57 and 84 (Main Period)|"Main Period FAS included all randomized participants, regardless of whether they took study medication. n in each of the categories is the number of participants with data available at the given time-point."||score on a scale||Standard Deviation|Mean
645766|NCT02165826|Secondary|Change From Baseline in Pre-bronchodilator Forced Vital Capacity (FVC) During the Down-Titration Period|Forced vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Pulmonary function testing was performed using spirometry prior to taking study medication. A positive change from Baseline indicates improvement.|Baseline DT (Day 1 of Down-Titration Period) to Days 14, 28 and 56 (Down-Titration Period)|Down-Titration Period Full Analysis Set (FAS) included all randomized participants who entered this period, regardless of whether they took study medication.||Liters||Standard Deviation|Mean
645767|NCT02165826|Secondary|Change From Baseline in Pre-bronchodilator Forced Vital Capacity (FVC) During the Main Period|Forced vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Pulmonary function testing was performed using spirometry prior to taking study medication. A positive change from Baseline indicates improvement.|Baseline (Day 1 of Main Period) to Days 15, 29, 57 and 84 (Main Period)|"Main Period FAS included all randomized participants, regardless of whether they took study medication. n in each of the categories is the number of participants with data available at the given time-point."||Liters||Standard Deviation|Mean
645768|NCT02165826|Secondary|Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1) During the Main Period|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Pulmonary function testing was performed using spirometry prior to taking study medication. A positive change from Baseline indicates improvement.|Baseline (Day 1 of Main Period) to Days 15, 29, 57 and 84 (Main Period)|"Main Period FAS included all randomized participants, regardless of whether they took study medication. n in each of the categories is the number of participants with data available at the given time-point."||Liters||Standard Deviation|Mean
645769|NCT02165826|Secondary|Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1) During the Down-Titration Period|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Pulmonary function testing was performed using spirometry prior to taking study medication. A positive change from Baseline indicates improvement.|Baseline DT (Day 1 of Down-Titration Period) to Days 14, 28 and 56 (Down-Titration Period)|"Down-Titration Period Full Analysis Set (FAS) included all randomized participants who entered this period, regardless of whether they took study medication. n in each category is the number of participants with data available at the given time-point."||Liters||Standard Deviation|Mean
645770|NCT02165826|Secondary|Percentage of Participants Prematurely Discontinuing Study Treatment Due to Any Reason During Down-Titration Period||Baseline DT (Day 1 of Down-Titration Period) to Week 8 (Down-Titration Period)|Down-Titration Period Full Analysis Set (FAS) included all randomized participants who entered this period, regardless of whether they took study medication.||percentage of participants|||Number
645771|NCT02165826|Secondary|Change From Baseline (V0DT) in Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1) to Final Visit of the Down-Titration Period|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Pulmonary function testing was performed using spirometry prior to taking study medication A positive change from Baseline indicates improvement.|Baseline (V0DT) [assessment at end of main period] and Final Visit of Down-Titration Period (Up to Day 56)|Participants from the Down-Titration Period Full Analysis Set (FAS), all randomized participants who entered this period, regardless of whether they took study medication, with data available for analysis.||Liters||Standard Deviation|Mean
645772|NCT02165826|Secondary|Percentage of Participants With Adverse Events of Interest|Adverse events of interest to evaluate tolerability are defined as diarrhea, nausea, headache, decreased appetite, insomnia and abdominal pain.|Baseline to Week 12 (Main Period)|SAS included all randomized participants who took at least one dose of study medication.||percentage of participants|||Number
645773|NCT02165826|Primary|Percentage of Participants Prematurely Discontinuing Study Treatment Due to Any Reason|The primary endpoint is the percentage of participants prematurely discontinuing study treatment for any reason during the Main Period from Visit 1 (V1) to Last Visit (Vend). Discontinuation is defined as permanently stopping randomized treatment; participants who resume randomized treatment after an interval will not be counted as having discontinued. The analysis used discontinuations occurring during the Main Period, irrespective of whether a participant subsequently entered into the Down-Titration Period.|Baseline to Week 12 (Main Period)|Safety Analysis Set (SAS) included all randomized participants who took at least one dose of study medication.||percentage of participants|||Number
645774|NCT02165462|Secondary|Age of Patients With Haemophilia||Screening visit|||years||Standard Deviation|Mean
645775|NCT02165462|Secondary|Body Mass Index of Patients With Haemophilia|The body mass index of patients was calculated using a TANITA equipment (TBF-300WA model, Tanita Corporation of America, Inc., Illinois, USA).|Screening visit|||kg/m2||Standard Deviation|Mean
645776|NCT02165462|Secondary|Height of the Patients With Haemophilia|The height of patients was calculated using a TANITA equipment (TBF-300WA model, Tanita Corporation of America, Inc., Illinois, USA).|Screening visit|||cm||Standard Deviation|Mean
645777|NCT02165462|Secondary|Joint Bleeding Before the Assessment||Screening visit|||participants|||Number
645778|NCT02165462|Secondary|Diagnosis, Severity of Hemophilia, Treatment (Prophylactic or on Demand)|Patients fill out a registration key clinical data (type, severity of hemophilia, hemarthrosis in the previous month and current drug therapy).|Screening visit|||participants|||Number
645779|NCT02165462|Secondary|Weight of the Patients With Haemophilia|The weight were collected using a TANITA equipment (TBF-300WA model, Tanita Corporation of America, Inc., Illinois, USA)|Screening visit|||Kg||Standard Deviation|Mean
645780|NCT02165462|Primary|Assessment of Maximal Velocity of Movement|Assessment of maximal velocity of movement with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)|Screening visit|The maximum speed (Vmax) was calculated as the maximum value of the first integral of the force-time curve for bilateral contractions, left-sided and right-sided||m/s||Standard Deviation|Mean
645781|NCT02165462|Primary|Assessment of Rate of Development During the Acceleration Phase|Assessment of rate of development during the acceleration phase with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)|Screening visit|||N/s||Standard Deviation|Mean
645782|NCT02165462|Primary|Change of Joint Condition Based on Clinical Assessment|"Spanish version of the Haemophilia Joint Health Score 2.1 (HJHS). Additive scale that assesses from 0 to 24 points joint status of patients with haemophilia (0: no joint damage; 24: maximum joint damage).
The variables studied in this scale are: Swelling (range 0-3); Duration of swelling (range 0-1); Muscle atrophy (range 0-2); Crepitant in motion (range 0-2); Loss of Flexion (range 0-3); Loss of extension (range 0-3); Joint pain (range 0-2): Strength (range 0-4); Gait (range 0-4)"|Screening visit|||Units on a scale (range 0-24)||Standard Deviation|Mean
645783|NCT02165462|Primary|Assessment of Rate of Development During the Preparation Phase|Assessment of rate of development during the preparation phase with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)|Screening visit|||N/s||Standard Deviation|Mean
645784|NCT02165462|Primary|Assessment of Maximal Peak Force|Assessment of maximal peak force with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)|Screening visit|The maximum peak force (MPF) is defined as the maximum achieved in the force-time curve during the dynamic test plantar flexion for both bilateral conditions as right and left unilateral, normalized to body weight of the participants (N / kg value)||N/kg||Standard Deviation|Mean
645785|NCT02165462|Primary|Assessment of Bilateral Index of Rate of Development During the Acceleration Phase|Assessment of bilateral index of rate of development during the acceleration phase with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)|Screening visit|"Bilateral rates was calculated during the acceleration phase to express relative difference in strength between bilateral and unilateral conditions (calculated in percentages). Based on information in the Howard and Enoka (1991), the calculation detail for the Bilateral Index is [100x (bilateral) / (right unilateral + left unilateral)] - 100"||percentage||Standard Deviation|Mean
645786|NCT02165462|Primary|Assessment of Bilateral Index of Rate of Development During the Preparation Phase|Assessment of Bilateral index of rate of development during the preparation phase with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)|Screening visit|"Bilateral rates was calculated during the preparation phase to express relative difference in strength between bilateral and unilateral conditions (calculated in percentages). Based on information in the Howard and Enoka (1991), the calculation detail for the Bilateral Index is [100x (bilateral) / (right unilateral + left unilateral)] - 100"||percentage||Standard Deviation|Mean
645787|NCT02165462|Primary|Assessment of Bilateral Index of Maximal Peak Force|Assessment of bilateral index of maximal peak force with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA).|Screening visit|"Bilateral rates was calculated during the preparation phase and during the acceleration phase to express relative difference in strength between bilateral and unilateral conditions. Based on information in the Howard and Enoka (1991), the calculation detail for the Bilateral Index is [100x (bilateral) / (right unilateral + left unilateral)] - 100"||percentage||Standard Deviation|Mean
645788|NCT02165111|Secondary|Assessment of Raynaud's Symptom Severity Using the VAS for Pain.|A secondary outcome of this study is pain as measured by the validated visual-analog scale (VAS) for pain. The VAS pain instrument measures pain on a scale from 0 cm (no pain) to 10 cm (extreme pain)|Measured at one month post-injection.|||centimeters measured on a visual scale||Standard Deviation|Mean
645789|NCT02165111|Secondary|Assessment of Raynaud's Symptom Severity Using the McCabe Cold Sensitivity Score.|A secondary outcome of this study is the patient-reported sensitivity to coldness as measured by the McCabe Cold Sensitivity score. Patients' answers on this validated instrument are scored on a scale from 0 (no sensitivity) to 400 (extreme sensitivity), where a higher number represents a worse outcome.|Measured at one month post-injection.|||Units on a scale||Standard Deviation|Mean
645790|NCT02165111|Secondary|Assessment of Raynaud's Symptoms Severity Using the Quick-DASH Score.|A secondary outcome of this study is severity of Raynaud's symptoms as measured by the self-reported Quick-DASH score. The Quick-DASH scores measures the degree of hand and upper extremity function on a scale of 0 (not limited) to 100 (severely limited) where a higher value represents a worse outcome.|Measured at one month post-injection.|||Units on a scale||Standard Deviation|Mean
645792|NCT02165111|Secondary|Rate of Change in Raynaud's Phenomenon Symptoms Measured With the Raynaud's Condition Score.|"Raynaud's Condition Score is a patient-reported, validated outcomes scale that measures the severity of Raynaud's phenomenon on a scale of 0 (No difficulty) to 10 (Extreme difficulty), where higher values represent a worse outcome.
Data from each weekly report were combined using a statistical model (generalized linear population-average model) to calculate a weekly rate of change for each participant's hand, where a negative value represents a improvement over time and a positive value represents worsening over time."|Weekly rate of change over the four-month study period.|||change in RCS/week||95% Confidence Interval|Mean
645793|NCT02165111|Primary|Change in Digital Blood Flow From Pre- to Post-injection.|The primary outcome measure is change in blood flow to the fingers, from a pre-injection baseline to post-injection follow-up visit as measured by non-invasive laser Doppler imaging.|Measured pre-injection and at one month post-injection.|||Blood flow, measured in LDI flux units,||95% Confidence Interval|Mean
645794|NCT02165072|Primary|Percent Collapse of the Inferior Vena Cava in Patients With Acute Kidney Injury|The investigators will measure the maximum and minimum diameters of the inferior vena cava with patients with acute kidney injury and calculate the percent change between the maximum and minimum diameters.|Day 1 of ICU admission|||Percent change||Standard Deviation|Mean
645795|NCT02165072|Primary|Maximum and Minimum Diameters of the Inferior Vena Cava in Patients With Acute Kidney Injury|The investigators will measure the maximum and minimum diameters of the inferior vena cava with patients with acute kidney injury.|Day 1 of ICU admission|||cm||Standard Deviation|Mean
645816|NCT02163915|Secondary|AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for TAK-137|Area under the plasma concentration-time curve during a dosing interval, where tau is the length of the dosing interval.|Days 1 and 7 pre-dose and at multiple timepoints (up to 24 hours) post-dose|Pharmacokinetic analysis set was defined as all participants who received at least one dose of study drug and had at least one measurable plasma concentration.||nanogram hours per milliliter (ng*hr/mL)||Standard Deviation|Mean
645858|NCT02161016|Other Pre-specified|Time to Full Weight-bearing|This will be the time from the date of surgery until the patient has full, unassisted weight bearing, and will be measured in weeks.|up to 24 months||||||
645811|NCT02164396|Primary|Lid-Parallel Conjunctival Folds (LIPCOF)|LIPCOF was assessed at baseline to 2-, 4-, 8- and 12- week Follow-up. Each subject eye was graded using a 4- point using the scale (Grade 0: No conjunctival folds, Grade 1: One permanent and clear parallel fold, Grade 2: Two permanent and clear parallel folds, (normally lower than 0.2mm) and Grade 3: More than two permanent and clear parallel folds, (normally higher than 0.2mm) at two 2 locations in the eye (Temporal and Nasal). The graded responses for each location (Temporal and Nasal) was average. The sum of the average LIPCOF grade for Temporal and Nasal was reported. (Score=average Nasal Grade + average Temporal Grade).|Baseline, 2-, 4-, 8- and 12-Week Follow-up|The analysis population consists of all subjects that completed the study without a major protocol deviation.||Score|Participants|Standard Deviation|Mean
645815|NCT02163915|Primary|Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters at Least Once Post Dose||Day 1 up to Day 8|Safety analysis set was defined as all participants who received at least one dose of study drug.||percentage of participants|||Number
645819|NCT02163915|Secondary|Cmax: Maximum Observed Plasma Concentration for TAK-137|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Day 1 pre-dose and at multiple timepoints (up to 24 hours) post-dose|Pharmacokinetic analysis set was defined as all participants who received at least one dose of study drug and had at least one measurable plasma concentration.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
645820|NCT02163915|Primary|Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Heart Rate Measurements at Least Once Post Dose||Day 1 up to Day 8|Safety analysis set was defined as all participants who received at least one dose of study drug.||percentage of participants|||Number
645821|NCT02163915|Primary|Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Blood Pressure Measurements at Least Once Post Dose||Day 1 up to Day 8|Safety analysis set was defined as all participants who received at least one dose of study drug.||percentage of participants|||Number
645822|NCT02163915|Primary|Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Pulse Measurements at Least Once Post Dose||Day 1 up to Day 8|Safety analysis set was defined as all participants who received at least one dose of study drug.||percentage of participants|||Number
645823|NCT02163915|Primary|Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose||Day 1 up to Day 8|Safety analysis set was defined as all participants who received at least one dose of study drug.||percentage of participants|||Number
645824|NCT02163915|Primary|Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|Day 1 up to Day 14|Safety analysis set was defined as all participants who received at least one dose of study drug.||percentage of participants|||Number
645825|NCT02163733|Secondary|t1/2 of AZ5104 and AZ7550|Pharmacokinetics of AZ5104 and AZ7550 (metabolites to AZD9291) by assessment of the terminal half-life.|Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, and 216 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >10% of Cmax for respective metabolite).||h||Full Range|Geometric Mean
645826|NCT02163733|Secondary|Tmax of AZ5104 and AZ7550|Pharmacokinetics of AZ5104 and AZ7550 (metabolites to AZD9291) by assessment of time to Cmax.|Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, and 216 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >10% of Cmax for respective metabolite).||h||Full Range|Median
645827|NCT02163733|Secondary|AUC(0-120) of AZ5104 and AZ7550|Pharmacokinetics of AZ5104 and AZ7550 (metabolites to AZD9291) by assessment of area under the plasma concentration time curve from zero to 120 hours.|Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 120 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >10% of Cmax for respective metabolite).||nM*h||Full Range|Geometric Mean
645828|NCT02163733|Secondary|AUC(0-t) of AZ5104 and AZ7550|Area under the plasma concentration curve from time zero to last quantifiable dose for AZ5104 and AZ7550 (metabolites to AZD9291).|Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, and 216 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >10% of Cmax for respective metabolite).||nM*h||Full Range|Geometric Mean
645829|NCT02163733|Secondary|Cmax of AZ5104 and AZ7550|Pharmacokinetics of AZ5104 and AZ7550 (metabolites to AZD9291) by assessment of maximum plasma concentration.|Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, and 216 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >10% of Cmax for respective metabolite).||nM||Full Range|Geometric Mean
645830|NCT02163733|Secondary|AUC(0-72) of AZ5104 and AZ7550|Pharmacokinetics of AZ5104 and AZ7550 (metabolites to AZD9291) by assessment of area under the plasma concentration time curve from zero to 72 hours.|Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >10% of Cmax for respective metabolite).||nM*h||Full Range|Geometric Mean
645831|NCT02163733|Secondary|Vz/F of AZD9291|Rate and extent of absorption of AZD9291 by assessment of the apprarent volume of distribution.|Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, and 216 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >5% of Cmax).||L||Full Range|Geometric Mean
645859|NCT02161016|Secondary|CT Scan|A CT scan will be done at 6 months in order to assess bone fusion.|6 months||||||
645832|NCT02163733|Secondary|CL/F of AZD9291|Rate and extent of absorption of AZD9291 by assessment of apparent clearance following oral administration.|Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, and 216 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >5% of Cmax).||L/h||Full Range|Geometric Mean
645833|NCT02163733|Secondary|t1/2 of AZD9291|Pharmacokinetics of AZD9291 by assessment of the terminal half-life.|Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, and 216 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >5% of Cmax).||h||Full Range|Geometric Mean
645834|NCT02163733|Secondary|Tmax of AZD9291|Pharmacokinetics of AZD9291 by assessment of time to Cmax.|Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, and 216 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >5% of Cmax).||h||Full Range|Median
645835|NCT02163733|Secondary|AUC(0-120) of AZD9291|Pharmacokinetics of AZD9291 by assessment of area under the plasma concentration time curve from zero to 120 hours.|Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 120 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >5% of Cmax).||nM*h||Full Range|Geometric Mean
645836|NCT02163733|Secondary|AUC(0-t) of AZD9291|Area under the plasma concentration curve from time zero to last quantifiable dose.|Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, and 216 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >5% of Cmax).||nM*h||Full Range|Geometric Mean
645837|NCT02163733|Secondary|AUC of AZD9291|Area under the plasma concentration curve from zero extrapolated to infinity.|Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, and 216 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >5% of Cmax).||nM*h||Full Range|Geometric Mean
645838|NCT02163733|Primary|Cmax of AZD9291|Pharmacokinetics of AZD9291 by assessment of maximum plasma AZD9291 concentration.|Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, and 216 hours post AZD9291 dose in Part A.|All patients had at least 1 dose AZD9291 and had sufficient postdose PK to determine parameter without important protocol deviations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >5% of Cmax). Note 1 patient missing key 8 hour sample so not included in Cmax analysis.||nM||Full Range|Geometric Mean
645839|NCT02163733|Primary|AUC(0-72) of AZD9291|Pharmacokinetics of AZD9291 by assessment of area under the plasma concentration time curve from zero to 72 hours.|Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >5% of Cmax).||nM*h||Full Range|Geometric Mean
645840|NCT02163421|Primary|Population Mean Estimate for Bioavailability Following Subcutaneous (SC) Administration|Bioavailability is defined as the rate and extent to which the active moiety of the e.g. subcutaneous administered drug reaches the systemic circulation. Population mean estimate for bioavailability was based on population pharmacokinetic (PK) analysis to find one measure. The exposure data were pooled across visits and subjects to identify population PK parameter estimates and covariate effects. The outcome measure data was planned to be analyzed using a model collating all arms measures to report pooled data across arms, as per planned analysis. Bioavailability was estimated using population pharmacokinetic (popPK) analysis.|Day 1: predose and on multiple time points (up to Day 127)|The pharmacokinetic analysis set included all randomized participants who received study treatment and who had at least 1 measurable pharmacokinetic concentration.||percentage of drug||95% Confidence Interval|Number
645841|NCT02163395|Secondary|The Implant Survival|A surviving implant is an integrated implant in the patient's jaw bone at the time of assessment.|Measured at Week 26, Month 24 and Month 36|Implant survival rates provided for the patients of the ITT population, who had valid data. Missing data were not imputed.||percentage of participants||95% Confidence Interval|Number
645842|NCT02163395|Secondary|Mean Bone Level Changes (Distal and Mesial)|A radiographic stent was produced to have a standard measurement. The distal and mesial bone levels were combined into a single value by averaging the two values. Negative bone level changes representing bone loss between baseline and follow-up visits, vice versa positive changes representing bone gain.|Measured at Week 26, Month 12, Month 24 and Month 36|Standardised bone level measurements provided for the ITT population. Missing data were not imputed.||mm||Standard Deviation|Mean
645860|NCT02161016|Secondary|Foot Ankle Disability Index|The Foot Ankle Disability Index (FADI) is a self-report of function that assesses activities of daily living, with scores ranging from 0 to 100.|24 months||||||
645861|NCT02161016|Secondary|SF-36 Score|The SF-36 is a survey for health and well-being.|24 months||||||
645862|NCT02161016|Primary|AOFAS Foot-and-Ankle Score|The American Orthopaedic Foot and Ankle Society score returns an indexed score, from 0 - 100, to assess clinical outcomes following foot /ankle surgery.|24 months||||||
645843|NCT02163395|Secondary|The Implant Success|"According to Buser et al 1992 an implant will be deemed a success if all of the following success criteria apply.
Absence of persisting subjective discomfort such as pain, foreign body perception and or dysaesthesia (painful sensation)
Absence of a recurrent peri-implant infection with suppuration (where an infection is termed recurrent if it is observed at two or more follow-up visits after treatment with systemic antibiotics)
Absence of implant mobility on manual palpation
Absence of any continuous peri-implant radiolucency"|Measured at Week 26, Month 12, Month 24 and Month 36|Implant success rates provided for the patients of the ITT population, who had valid data. Missing data were not imputed.||percentage of participants||95% Confidence Interval|Number
645844|NCT02163395|Primary|The Implant Survival|A surviving implant is an integrated implant in the patient's jaw bone at the time of assessment.|Measured at 12 months +/- 4 weeks after implant placement|Implant survival rates provided for the patients of the ITT population, who had valid data. Missing data were not imputed.||percentage of participants||95% Confidence Interval|Number
645848|NCT02162862|Primary|Change in Baseline in Pittsburgh Sleep Quality Index (PSQI) for Each Arm|PSQI score range is 0-21 with higher score indicating greater sleep disturbance.|Baseline (week 0) to end of study (week 14)|||units on a scale||Standard Deviation|Mean
645849|NCT02162862|Primary|Change From Baseline in Multidimensional Fatigue Inventory (MFI) for Each Arm|MFI score range is 0-100. Higher score indicates higher level of fatigue.|Baseline (week 0) to end of study (week 14)|||units on a scale||Standard Deviation|Mean
645850|NCT02162758|Secondary|Change From Baseline in the Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) Total Score|The GERD-HRQL score consisted of 10 questions, where participants were required to answer each question on a scale of 0 to 5 (0: no symptoms; 1: symptoms noticeable but not bothersome; 2: symptoms noticeable and bothersome but not every day; 3: symptoms bothersome every day; 4: symptoms affect daily activity; 5: symptoms are incapacitating to do daily activities). The total score was derived by simply adding the individual score of each question. The total score ranged from 0 to 50 where a higher score indicated more severe disease. The best possible total GERD-HRQL score was 0 (asymptomatic in all questions) and the worst possible score is 50 (incapacitated in all questions).|Baseline and Month 12|The ITT population included all randomized participants who had documented CEIM at screening and took at least 1 dose of study drug during the treatment period.||units on scale||Standard Deviation|Mean
645851|NCT02162758|Secondary|Percentage of Participants With Erosive Esophagitis (EE)|The severity of EE was classified into following grades: Grade A: one or more mucosal breaks no longer than 5 millimeter (mm), none of which extends between the tops of the mucosal folds; Grade B: one or more mucosal breaks more than 5 mm long, none of which extends between the tops of two mucosal folds; Grade C: mucosal breaks that extend between the tops of two or more mucosal folds, but which involve less than 75 percent (%) of the esophageal circumference; Grade D: mucosal breaks which involve at least 75% of the esophageal circumference.|Baseline up to Month 12|The ITT population where EE assessment was available. The ITT population included all randomized participants who had documented CEIM at screening and took at least 1 dose of study drug during the treatment period.||percentage of participants|||Number
645852|NCT02162758|Secondary|Percentage of Participants With Recurrence of IM With Dysplasia|Recurrence of IM with dysplasia was defined as an esophageal biopsy result indicating BE with dysplasia.|Month 12|The ITT population where Month 12 esophageal biopsy assessment was available. The ITT population included all randomized participants who had documented CEIM at screening and took at least 1 dose of study drug during the treatment period.||percentage of participants|||Number
645853|NCT02162758|Primary|Percentage of Participants With Recurrence of Intestinal Metaplasia (IM)|Recurrence of IM was defined as an esophageal biopsy result indicating BE with or without dysplasia.|Month 12|The Intent-to-treat (ITT) population where Month 12 esophageal biopsy assessment was available. The ITT population included all randomized participants who had documented CEIM at screening and took at least 1 dose of study drug during the treatment period.||percentage of participants|||Number
645854|NCT02162680|Primary|Differences in Patients' Perceptions of Pain Between Treatment Methods|The visual analog pain scale is a patient-reported measure of pain on a 10-point scale with 0 being no pain and 10 being worst possible pain. The visual analog pain score will be completed at the following time points: pre injection, during injection, and during catheter insertion.|at pre injection, during anesthetic injection, and during catheter insertion, up to approximately 1 minute|||units on a scale||Standard Deviation|Mean
645855|NCT02161549|Primary|Mean Score of Boston Bowel Preparation Scale (BBPS) Index Prior and After the Use of MotusGI CleanUp System|Human colon has 3 segments and each segment can be scored 0 (unprepared colon) - 3 (clean colon). average of all colon segments BBPS score after the use of MotusGI CleanUp System|during colonoscopy procedure after cleansing with CleanUp System|the mean and standard deviation of the average score after cleansing the colon using the Motus CleanUp System||units on a scale||Standard Deviation|Mean
645856|NCT02161146|Secondary|Conjunctival Hyperemia Score|Hyperemia is the engorgement of the blood vessels (redness) of the eye. Ocular hyperemia was evaluated by the investigator 8 hours after AGN-229666 and vehicle administration and 4 hours after olopatadine administration, 15 minutes post allergen challenge using a 0 to 4 scale with 0.5 grade increments where: 0=none (no hyperemia) to 4.0=extremely severe (large, numerous dilated blood vessels characterized by severe deep red color). Data from Days 1 and 15 were pooled together and averaged.|Days 1 and 15|Participants from the Intent-to-Treat Population, all randomized participants, with data of treated eyes available for analysis.||score on a scale|Participants|Standard Deviation|Mean
645857|NCT02161146|Primary|Ocular Itching Score|Ocular itching was assessed by the participant 8 hours after AGN-229666 and vehicle administration and 4 hours after olopatadine administration, 5 minutes post allergen challenge using a 0 to 4 scale with 0.5 grade increments where: 0=none (no itching) to 4.0=incapacitating itch with an irresistible urge to rub (worst). Data from Days 1 and 15 were pooled together and averaged.|Days 1 and 15|Participants from the Intent-to-Treat Population, all randomized participants, with data of treated eyes available for analysis.||score on a scale|Participants|Standard Deviation|Mean
645863|NCT02160990|Secondary|Aggregate Satiation Symptom Score|"Postprandial fullness, nausea, bloating, and pain were measured 30 minutes after the liquid meal using 100 mm horizontal visual analog scales (VAS). The subscale scores could each range from none(0) to worst ever (100) at the left and right ends of the lines for each symptom. These satiation symptom scores (postprandial fullness, nausea, bloating, and pain) were combined to generate a total scale score with a different total scale range (0 - 400 mm) with 0 mm indicating none and 400 indicating worst ever."|Visit 3, approximately 30 min after ingestion of nutrient drink test|||mm||Inter-Quartile Range|Median
645864|NCT02160990|Secondary|Buffet Meal Intake (kcal)|"Five hours after the standard egg meal ingested to measure gastric emptying, subjects were invited to eat, over a 30 minute period, a standard all you can eat meal. This meal consisted of either meat or vegetable lasagna, vanilla pudding, and skim milk. Personnel from the study team weighed the food servings post-meal and reported the amount of food left from single portions partially consumed. The total kcal of the food consumed was analyzed by using validated software."|"Visit 4, approximately 30 minutes after start of all you can eat meal"|||kcal||Inter-Quartile Range|Median
645865|NCT02160990|Secondary|Maximum Tolerated Volume|In the last 5 days of medication administration, subjects did a satiation/nutrient drink test. Participants recorded their sensations every 5 minutes using a visual analog scale (VAS) from 0-5, with level 0 being no symptoms, level 3 corresponding to fullness sensation after a typical meal, and level 5 corresponding to the maximal tolerated volume (maximum or unbearable fullness/satiation). This measure was the volume consumed when the fullness sensation reached level 5.|Visit 3, approximately 30 minutes after liquid meal|||mL||Inter-Quartile Range|Median
645866|NCT02160990|Secondary|Satiation Expressed as Volume to Fullness|In the last 5 days of medication administration, subjects did a satiation/nutrient drink test. Participants recorded their sensations every 5 minutes using a visual analog scale (VAS) from 0-5, with level 0 being no symptoms, level 3 corresponding to fullness sensation after a typical meal, and level 5 corresponding to the maximal tolerated volume (maximum or unbearable fullness/satiation). This measure was the volume consumed when the fullness sensation reached level 3.|Visit 3, approximately 30 minutes after liquid meal|||mL||Inter-Quartile Range|Median
645867|NCT02160990|Secondary|Change in Body Weight||baseline, day 30|||kg||Inter-Quartile Range|Median
645868|NCT02160990|Secondary|Percentage of Gastric Contents Emptied at 1 Hour|Subjects were given a scrambled egg breakfast with toast and a glass of milk. The eggs contained a small amount of a radioactive substance. At the completion of the meal, subjects stood in front of a special camera and pictures were taken at specific intervals. This outcome measure is the proportion of the radiolabeled meal emptied at 1 hour.|Visit 4, approximately 1 hours after radiolabeled meal was ingested|||percentage of meal emptied||Inter-Quartile Range|Median
645869|NCT02160990|Primary|Gastric Emptying Half-time (T 1/2) of Solids|Gastric emptying of solids half-time is defined as the time for half of the ingested solids to leave the stomach. Subjects were given a scrambled egg breakfast with toast and a glass of milk. The eggs contained a small amount of a radioactive substance. Anterior and posterior gamma camera images were obtain immediately after radiolabeled meal ingestion, every 15 minutes for the first 2 hours, then 30 minutes for the next 2 hours (total 4 hours after the radiolabeled meal).|time frame is 30 days after the initiation of dose.|||minutes||Inter-Quartile Range|Median
645870|NCT02160977|Secondary|VAS(Visual Analogue Scale/Score) of the Knee Joint|Scale Name:score scale range:0~100,and a higher values represent a worse outcome|6 months|||units on a scale||Standard Deviation|Mean
645871|NCT02160977|Secondary|HSS(Hospital for Special Surgery) Score of the Knee Joint|Scale Name:score scale range:0~100,and a higher values represent a better outcome|6 months|||units on a scale||Standard Deviation|Mean
645872|NCT02160977|Primary|Proprioception of the Knee Post Operation|"Proprioception of the knee position sense was assessed by the knee angle reproduction test (10~20 degree, 30~40 degree, 80~90 degree of the knee flexion) prior operation, and 1 week, 6 weeks, 3 months and 6 months post operation.
Scale Name:degree scale range:0~180 degree,and a higher values represent a worse outcome"|six months|||units on a scale||Standard Error|Mean
645873|NCT02160873|Secondary|Urine Volume|Measurement of total urine output.|24 hour|||mililiters||Standard Deviation|Mean
645874|NCT02160873|Other Pre-specified|Exercise Metabolism|Indirect calorimetry will be used to assess macronutrient use during exercise via the respiratory exchange ratio|24 hours|||Respiratory exchange ratio||Standard Deviation|Mean
645875|NCT02160873|Secondary|Urine Specific Gravity|Changes in urine specific gravity will be measured pre and post a 10K time trial run on a treadmill|24 hours|||Urine specific gravity||Standard Deviation|Mean
645876|NCT02160873|Primary|Running Performance|10K time trial on a treadmill|24 hours|||minutes||Standard Deviation|Mean
645877|NCT02160314|Primary|Treatment-emergent Serious Adverse Event|proportion of intent-to-treat subjects who experience a treatment-emergent serious adverse event|3 month|Intent-to-treat (ITT)||participants|||Number
645878|NCT02159950|Other Pre-specified|Effects of Tasquinimod on the Inhibition of Immune Cells||Up to week 50|Due a Lack of funding data was not collected and no patients were analyzed.|||||
645879|NCT02159950|Secondary|Time to PSA Progression||Up to 3 years|Due a Lack of funding data was not collected and no patients were analyzed.|||||
645880|NCT02159950|Secondary|Progression-free Survival||Up to 3 years|Due a Lack of funding data was not collected and no patients were analyzed.|||||
645881|NCT02159950|Secondary|Overall Survival||Up to 3 years|Due a Lack of funding data was not collected and no patients were analyzed.|||||
645882|NCT02159950|Secondary|Objective Response Rates (Partial or Complete)||Up to 3 years|Due a Lack of funding data was not collected and no patients were analyzed.|||||
645883|NCT02159950|Secondary|Immune Response (Arm 2 Only)||Week 0|Due a Lack of funding data was not collected and no patients were analyzed.|||||
645884|NCT02159950|Secondary|Immune Response||Week 50|Due a Lack of funding data was not collected and no patients were analyzed.|||||
645885|NCT02159950|Secondary|Immune Response||Week 26|Due a Lack of funding data was not collected and no patients were analyzed.|||||
645886|NCT02159950|Secondary|Immune Response||Week 10|Due a Lack of funding data was not collected and no patients were analyzed.|||||
645887|NCT02159950|Secondary|Immune Response||Week 6|Due a Lack of funding data was not collected and no patients were analyzed.|||||
649394|NCT02081859|Primary|Clinical Pregnancy Rate|Patients will have a ultrasound to document fetal heart rate approximately 6 weeks after start of IVF cycle.|6 weeks|||Participants|||Count of Participants
645888|NCT02159950|Secondary|Frequency of Toxicities Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4|The frequency of participants with toxicities will be tabulated by grade across all dose levels and courses.|Up to 3 years|All treated and eligible patients.||participants|||Number
645889|NCT02159950|Secondary|Duration of PSA Response||Up to 3 years|Due a Lack of funding data was not collected and no patients were analyzed.|||||
645890|NCT02159950|Secondary|Change in PSA Response|PSA doubling time, PSA slope|Baseline to up to 3 years|Due a Lack of funding data was not collected and no patients were analyzed.|||||
645891|NCT02159950|Primary|Change in Immune Response Assessed by IFN-g ELISPOT Specific for PA2024||Baseline up to 50 weeks|Due a Lack of funding data was not collected and no patients were analyzed.|||||
645892|NCT02159859|Other Pre-specified|Number of Participants With Any Adverse Events|Evaluation of any adverse events will be performed by the study physician at screening, predose, 24 hours, and 5 to 7 days after the ertapenem dose or the last day of patient's stay in the hospital|Up to seven days after the administration of ertapenem|||Participants|||Count of Participants
645893|NCT02159859|Secondary|Number of Participants With Injection Site Reaction|Evaluation of injection site reaction will be performed by the study physician at screening, predose, 24 hours, and 5 to 7 days after the ertapenem dose or the last day of patient's stay in the hospital|Up to seven days after the administration of ertapenem|||Participants|||Count of Participants
645894|NCT02159859|Secondary|Number of Participants With Headache|Evaluation of headache will be performed by the study physician at screening, predose, 24 hours, and 5 to 7 days after the ertapenem dose or the last day of patient's stay in the hospital|Up to seven days after the administration of ertapenem|||Participants|||Count of Participants
645895|NCT02159859|Secondary|Number of Participants With Nausea and Vomiting|Evaluation of nausea and vomiting will be performed by the study physician at screening, predose, 24 hours, and 5 to 7 days after the ertapenem dose or the last day of patient's stay in the hospital|Up to seven days after the administration of ertapenem|||Participants|||Count of Participants
645896|NCT02159859|Secondary|Number of Participants With Diarrhea|Evaluation of diarrhea will be performed by the study physician at screening, predose, 24 hours, and 5 to 7 days after the ertapenem dose or the last day of patient's stay in the hospital|Up to seven days after the administration of ertapenem|||Participants|||Count of Participants
645897|NCT02159859|Primary|Mean Time to Cmax of Ertapenem in Hemodialysis Patients|Mean time to Cmax will be calculated from a series of ertapenem concentration from the blood samples, i.e.once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session|once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session|||hours||Standard Deviation|Mean
645898|NCT02159859|Primary|Mean Terminal Half Life (t1/2) of Ertpenem in Hemodialysis Patients|Mean t1/2 will be calculated from a series of ertapenem concentration from the blood samples, i.e.once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session|once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session|||hours||Standard Deviation|Mean
645899|NCT02159859|Primary|Mean Area Under the Curve (AUC) of Ertapenem in Hemodialysis Patients|Mean AUC will be calculated from a series of ertapenem concentration from the blood samples, i.e.once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session|once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session|||h*ug/mL||Standard Deviation|Mean
645900|NCT02159859|Primary|Mean Minimum Concentration (Cmin) of Ertapenem in Hemodialysis Patients|Mean Cmin will be calculated from a series of ertapenem concentration from the blood samples, i.e.once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session|once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session|||mcg/ml||Standard Deviation|Mean
645901|NCT02159859|Primary|Mean Maximum Concentration (Cmax) of Ertapenem in Hemodialysis Patients|Mean Cmax will be calculated from a series of ertapenem concentration from the blood samples, i.e.once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session|once after hemodialysis session prior to ertapenem administration and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session|||mcg/ml||Standard Deviation|Mean
645902|NCT02159768|Secondary|Transmission of Airtraq View of Larynx|The view of the larynx will be captured by the handphone attached to the Airtraq layryngoscope, and then transmitted to a second investigator.|Intra operative measurement, time frame within 5 minutes|The larynx could be visualized in all 30 patients using the handphone attached to the Airtraq. The images of the larynx could be transmitted to a remote assistant in all 30 patients.||participants|||Number
645903|NCT02159768|Primary|Visualization of Larynx With the Airtraq Laryngoscope and Handphone|The efficacy of viewing the larynx via the handphone attached to the Airtraq laryngoscope will be assessed.|Intra operative|Study participants in whom the Airtraq handphone visualization system was studied||participants|||Number
645904|NCT02159547|Secondary|Adverse Effects|The adverse effects is being recorded to the study form after the study drugs are administered at the 45th minutes.|45th minutes|||participants|||Number
645905|NCT02159547|Primary|Visual Analogue Scale Change|Change from baseline in Visual Analogue Scale, 100 mm, at 45th minutes. Visual Analogue Scale is measurement tool scoring tool between 0 (no pain) and 100 mm (worst pain). Minimum clinically significant change in pain score is 13 or 16 mm.|45 minutes|||units on a scale||95% Confidence Interval|Median
649986|NCT02063880|Secondary|Number of Participants With Potential Drug Toxicity|Participants with adverse events that are deemed to be potentially related to medications.|6 months post-HAART initiation|||participants|||Number
645906|NCT02159482|Secondary|Proportion of Patients Experiencing an Increase in the Magnitude of the Tumor Antigen-specific Immune Response|The proportion of patients experiencing an increase in the magnitude of the tumor antigen-specific immune response following the administration of interferon will also be estimated. Immune response will be determined by ELISPOT analysis.|4 weeks|Five subjects analysed due to one subject not completing blood draws.||percentage of participants|||Number
645907|NCT02159482|Primary|Proportion of Clinical Responders (Complete Response + Partial Response)|Response determination will be made according to the RECIST criteria. Complete response defined as the disappearance of target lesion, confirmed at 1-4 weeks. Partial response defined as 30% decrease in longest dimension of target lesion, confirmed at 1-4 weeks.|4 weeks|||percentage of participants|||Number
645908|NCT02159365|Secondary|Number of Participants With Any Grade and Grade 3 or Grade 4 (G3/4) Infusion Reactions Over the Entire Study Period|An infusion reaction in this study is defined as any relevant sign or symptom occurring during or after elotuzumab infusion and considered by the investigator as an infusion reaction. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Potentially Life-threatening or disabling, Gr 5=Death.|Date of first dose up to 60 days post last dose (approximately 4 years)||08/2018||||
645909|NCT02159365|Primary|Number of Participants With Grade 3 or Grade 4 (G3/4) Infusion Reactions by the End of Treatment Cycle 2 at Primary Endpoint|Infusion reaction was defined as any relevant sign or symptom occurring during or after elotuzumab infusion and considered by the investigator as an infusion reaction. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Potentially Life-threatening or disabling, Gr 5=Death.|From Day 1 to End of cycle 2 treatment (approximately 56 days)|All Treated Participants||participants||95% Confidence Interval|Number
645910|NCT02159352|Secondary|Number of Participants With Abnormalities in Urinalysis and Other Chemistry Testing Results|Criteria for marked abnormalities on laboratory test results: urinary dipstick blood: ≥2 if pretreatment (PreRx) <1, ≥2 if PreRx is missing or ≥2*PreRx if PreRx ≥1. Urinary microscopic red blood cell (RBC): ≥2 if PreRx <2, ≥2 if PreRx is missing or ≥4 if PreRx ≥2. Urinary microscopic white blood cell (WBC): ≥2 if PreRx <2, ≥2 if PreRx is missing or ≥4 if PreRx ≥2. Lactate dehydrogenase >1.25*upper limit of normal (ULN) if PreRx ≤ULN, >1.25*ULN if PreRx is missing and >1.5*PreRx if PreRx >ULN.|From start of study treatment (Day 1) to study discharge (up to 15 days)|All treated participants.||participants|||Number
645911|NCT02159352|Secondary|Number of Participants With Marked Abnormalities in Hematology Laboratory Test Results|Criteria for marked abnormalities in test results: Platelet count >1.5*upper limits of normal (ULN) value, >1.5*ULN if pretreatment (PreRx) value is missing, <0.85*lower limit of normal (LLN) if PreRx ≥LLN, <0.85*LLN if PreRx is missing, <0.85*PreRx if PreRx <LLN. Leukocytes >1.2*ULN if LLN ≤PreRx ≤ULN, >1.2*ULN if PreRx is missing, >1.5*PreRx if PreRx >ULN, >ULN if PreRx <LLN, <0.85*PreRx if PreRx <LLN, <0.9*LLN if LLN ≤PreRx ≤ULN, <0.9*LLN if PreRx is missing and <LLN if PreRx >ULN. Lymphocytes >7.5*10^3 c/uL and <0.75*10^3 c/uL. Neutrophils <0.85*PreRx if PreRx <1.5*ULN, <1.5*ULN if PreRx ≥1.5*ULN and <1.5*ULN if PreRx is missing.|From start of study treatment (Day 1) to study discharge (up to 15 days)|All treated participants.||participants|||Number
645912|NCT02159352|Secondary|Number of Participants With Abnormalities in Electrocardiogram (ECG) Findings|Abnormalities in ECG findings included: PR ≥210 msec, QRS ≥120 msec, QT ≥500 msec, QTcF ≥450 msec, and second- or third-degree heart block.|From start of study treatment (Day 1) to study discharge (up to 15 days)|All participants who received at least 1 dose of study drug||participants|||Number
645913|NCT02159352|Secondary|Number of Participants With Abnormalities in Vital Sign Measurements|Criteria for abnormalities in vital sign measurements: Diastolic blood pressure: Value >90 and change from baseline > 0 or value < 55 and change from baseline <-10. Systolic blood pressure: Value >140 and change from baseline >20 or value <90 and change from baseline <-20. Heart rate: Value >100 and change from baseline >30 or value <55 and change from baseline <-15. Respiration: Value >16 or change from baseline >10. Temperature: Value >38.3°C or change from baseline >1.6°C.|From start of study treatment (Day 1) to study discharge (up to 15 days)|Participants who received at least 1 dose of study drug||participants|||Number
645914|NCT02159352|Secondary|Number of Participants With Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs) and Who Died|AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.|From start of study treatment (Day 1) to study discharge for AEs (up to 15 days); Day 1 to 30 days after last dose of study treatment for SAEs (up to 44 days)|All participants who received at least 1 dose of study drug||participants|||Number
645915|NCT02159352|Secondary|Dose-normalized Area Under the Concentration-Time Curve in 1 Dosing Interval (AUC[TAU]/D) of Daclatasvir|AUC(TAU)/D was obtained from concentration-time plot of daclatasvir by using noncompartmental method by a validated pharmacokinetic analysis program.|Predose (0 hour) on Day 2, 3 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hours on Day 4 (Period 1); Predose (0 hour) on Day 12, 13 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hour on Day 14 (Period 2)|All treated participants with adequate pharmacokinetic profile. Here, N signifies number of participants evaluable for this outcome measure.||(ng*h/mL)/mg||Geometric Coefficient of Variation|Geometric Mean
645916|NCT02159352|Secondary|Dose-normalized Maximum Observed Plasma Concentration (Cmax/D) and Dose-normalized Plasma Concentration Observed at 24 Hours Postdose (C24/D) of Daclatasvir|Cmax/D and C24/D are obtained from concentration-time plot of daclatasvir by using noncompartmental method by a validated pharmacokinetic analysis program.|Predose (0 hour) on Day 2, 3 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hours on Day 4 (Period 1); Predose (0 hour) on Day 12, 13 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hour on Day 14 (Period 2)|All treated participants with adequate pharmacokinetic profile.||ng/mL/mg||Geometric Coefficient of Variation|Geometric Mean
645917|NCT02159352|Secondary|Plasma Concentration Observed at 24 Hours Postdose (C24) of Daclatasvir|C24 was obtained from concentration time plot of daclatasvir by using noncompartmental method by a validated pharmacokinetic analysis program.|Predose (0 hour) on Day 2, 3 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hours on Day 4 (Period 1); Predose (0 hour) on Day 12, 13 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hour on Day 14 (Period 2)|All treated participants with adequate pharmacokinetic profile. Here, N signifies number of participants evaluable for this outcome measure.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
645918|NCT02159352|Secondary|Time of Maximum Observed Plasma Concentration (Tmax) of Daclatasvir|Tmax was obtained from concentration-time plot of daclatasvir by using non-compartmental method by a validated pharmacokinetic analysis program.|Predose (0 hour) on Day 2, 3 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hours on Day 4 (Period 1); Predose (0 hour) on Day 12, 13 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hour on Day 14 (Period 2)|All treated participants with adequate pharmacokinetic profile. Here, N signifies number of participants evaluable for this outcome measure.||hours||Full Range|Median
645919|NCT02159352|Primary|Area Under the Concentration-Time Curve in 1 Dosing Interval (AUC[TAU]) for Daclatasvir|AUC(TAU) was the area under the curve from time zero to end of dosing interval. AUC(TAU) was obtained from concentration-time plot of daclatasvir using noncompartmental method and a validated pharmacokinetic analysis program.|Predose (0 hour) on Day 2, 3 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hours on Day 4 (Period 1); Predose (0 hour) on Day 12, 13 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hour on Day 14 (Period 2)|All treated participants with adequate pharmacokinetic profiles. Number of participants analyzed (N) signifies number of participants evaluable for this outcome measure.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
645920|NCT02159352|Primary|Maximum Observed Plasma Concentration (Cmax) for Daclatasvir|Cmax was obtained from concentration-time plot using a noncompartmental method and a validated pharmacokinetic analysis program.|Predose (0 hour) on Day 2, 3 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hours on Day 4 (Period 1); Predose (0 hour) on Day 12, 13 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hour on Day 14 (Period 2)|All treated participants with adequate pharmacokinetic profiles.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
645921|NCT02159118|Secondary|Amount of Time Lapsed From Needle to Skin Contact to Bone Marrow Biopsy Specimen Acquisition Using the Manual Device and the Powered Device|measurement of the amount of time required to acquire one bone marrow biopsy specimen. timing starts when the bone marrow aspiration and biopsy needle first contacts the skin and ends when the biopsy specimen has been collected.|at time of the bone marrow sampling procedure|All participants enrolled in the study were included in the analysis as the required sample size for the study was met. No participants were excluded from analysis. Analysis was made per protocol.||seconds||Standard Deviation|Mean
645922|NCT02159118|Secondary|Operator Satisfaction With Manual Device and Powered Device|Device operators will report their level of satisfaction with use of the manual device and the powered device to perform the bone marrow sampling procedure. Level of satisfaction is reported using a 0 to 10 scale, where higher numbers represent a higher level of satisfaction.|Within 24 hours of the bone marrow sampling procedure|All participants enrolled in the study were included in the analysis as the requires sample size for the study was met. No participants were excluded from analysis. Analysis was made per protocol.||units on a scale||Standard Deviation|Mean
645923|NCT02159118|Secondary|Patient Level of Post-procedural Pain Following Use of the Manual Device and the Powered Device|Within 4 hours of the bone marrow sampling procedure, the patient will report their level of pain post-procedure using the Wong-Baker FACES pain rating scale. The scale measures pain from 0-10, where higher numbers represent worse pain.|within 4 hours of the bone marrow sampling procedure|All participants enrolled in the study were included in the analysis as the required sample size for the study was met. No participants were excluded from analysis. Analysis was made per protocol.||units on a scale||Standard Deviation|Mean
645924|NCT02159118|Secondary|Amount of Time Lapsed From Needle to Skin Contact to Bone Marrow Aspiration Specimen Acquisition Using the Manual Device and the Powered Device|measurement of the amount of time required to acquire a bone marrow aspiration specimen. timing starts when the bone marrow aspiration and biopsy needle first contacts the skin and ends when the aspiration specimen has been collected.|at time of the bone marrow sampling procedure|All participants enrolled in the study were included in the analysis as the required sample size for the study was met. No participants were excluded from analysis. Analysis was made per protocol.||seconds||Standard Deviation|Mean
645925|NCT02159118|Secondary|Bone Marrow Biopsy Specimen Capture Rate for the Manual Device and the Powered Device|number of needle passes required to capture one bone marrow biopsy specimen using the manual device and the powered device|at time of the bone marrow sampling procedure|All participants enrolled in the study were included in the analysis, as the required sample size for the study was met. No participants were excluded from analysis. Analysis was made per protocol.||needle passes|Participants|Standard Deviation|Mean
645926|NCT02159118|Secondary|Bone Marrow Biopsy Specimen Size (Volume) Obtained Using the Manual Device and the Powered Device|bone marrow biopsy specimens will be evaluated by a blinded pathologist and measured for volume|within 24 hours of the bone marrow sampling procedure|All participants enrolled in the study were included in the analysis, as the required sample size for the study was met. No participants were excluded from analysis. Analysis was made per protocol.||mm3||Standard Deviation|Mean
645927|NCT02159118|Secondary|Bone Marrow Biopsy Specimen Size (Width) Obtained Using the Manual Device and the Powered Device|bone marrow biopsy specimens will be evaluated by a blinded pathologist and measured for width.|within 24 hours of the bone marrow sampling procedure|All participants enrolled in the study were included in the analysis, as the required sample size for the study was met. No participants were excluded from analysis. Analysis was made per protocol.||mm||Standard Deviation|Mean
645928|NCT02159118|Secondary|Bone Marrow Biopsy Specimen Size (Length) Obtained Using the Manual Device and the Powered Device|bone marrow biopsy specimens will be evaluated by a blinded pathologist and measured for length.|within 24 hours of the bone marrow sampling procedure|All participants enrolled in the study were included in the analysis, as the required sample size for the study was met. No participants were excluded from analysis. Analysis was made per protocol.||mm||Standard Deviation|Mean
645929|NCT02159118|Primary|Percent of Hematopoietic Tissue Present in Bone Marrow Biopsy Specimens Obtained Using the Manual Device and Powered Device|Bone marrow biopsy specimens will be evaluated by a blinded pathologist and measured for percent of hematopoietic tissue present. Higher percentage of hematopoietic tissue present in a biopsy specimen indicates a larger quantity of specimen for pathological evaluation.|within 24 hours of bone marrow sampling procedure|All participants enrolled in the study were included in analysis, as the required sample size for the study was met. No subjects were excluded from analysis. Analysis was made per protocol.||% Hematopoetic tissue present||Standard Deviation|Mean
646309|NCT02149875|Secondary|Barthel Index Score|Range from 0, indicating complete dependence on help with activities of daily living, to 100, indicating independence|At 11-day and 21-day after therapy|||units on a scale||Standard Deviation|Mean
645931|NCT02159040|Secondary|Rate of Infection|Median number of infections (positive bacterial, viral or fungal culture, or infection requiring IV antimicrobial, or infection resulting in hospitalization or death) in patients treated with azacitidine alone vs. azacitidine + deferasirox|up to 24 months|Only one patient in trial. No analysis will ever be done.|||||
645932|NCT02159040|Secondary|Incidence of Adverse Events|Incidence of adverse events (AEs) overall and by severity, and serious adverse events (SAEs).|up to 24 months|Only one patient in trial. No analysis will ever be done.|||||
645933|NCT02159040|Secondary|Change in Serum Ferritin|Change in Serum Ferritin|up to 24 months|Only one patient in trial. No analysis will ever be done.|||||
645934|NCT02159040|Secondary|Time to AML Transformation|Time to AML transformation is defined as time from the date of the first dose of study treatment to the date of the first documented bone marrow blast count ≥ 20% per WHO classification 1999.|Up to 24 months|Only one patient in trial. No analysis will ever be done.|||||
645935|NCT02159040|Secondary|Overall Survival|Overall survival is defined as time from the date of the first dose of study treatment to the date of death from any cause.|up to 24 months|Only one patient in trial. No analysis will ever be done.|||||
645936|NCT02159040|Secondary|Progression Free Survival|Progression free survival is defined as time from the date of the first dose of study treatment to the date of the first documented disease progression or relapse per IWG 2006 criteria.|Up to 24 months|Only one patient in trial. No analysis will ever be done.|||||
645937|NCT02159040|Secondary|Duration of Response|Duration of response is defined as time from the date of the first observed hematologic improvement to the date of the first subsequent documented disease progression or relapse per IWG 2006 criteria.|up to 24 months|Only one patient in trial. No analysis will ever be done.|||||
645938|NCT02159040|Secondary|Time to Response|Time to response is defined as time from the date of the first dose of study treatment to the date of the first documented hematologic improvement.|up to 24 months|Only one patient in trial. No analysis will ever be done.|||||
645939|NCT02159040|Primary|Overall Response Rate Per IWG 2006 Criteria|ORR (inclusive of CR, PR and HI) per IWG 2006 criteria including erythroid response, platelet response and neutrophil response over the course of one year. Hematologic improvement must be maintained for at least 8 weeks in order to count as HI.|1 year|Only one patient in trial. No analysis will ever be done.|||||
645940|NCT02158728|Primary|Number of Electrocardiograms (ECGs) Collected|Collected were the number of ECGs received from the enrolled subjects, the number of ECGs with SVT (supraventricular tachycardia) episodes, and the number of ECGs with SVT episodes qualified for algorithm development and validation of the potential new ICD. The ECG data were collected continuously during the indicated procedure (ICD/CRT-D implant, ICD/CRT-D change-out, electrophysiology (EP) study (including non invasive EP study)|After recorded ECGs had been received, which were collected until the end of the indicated procedure|Total number of ECGs received from the 80 enrolled subjects.||ECG|||Number
645941|NCT02158572|Other Pre-specified|Cycle Control|Number of episodes of breakthrough bleeding (BTB) and/or breakthrough spotting (BTS) per cycle.|1 year|Subjects that reported BTB and/or BTS||Episodes/cycle||Standard Deviation|Mean
645942|NCT02158572|Other Pre-specified|Self-reported Patch Adhesion|"Patch adhesion was reported using the following 5-point scoring method:
0: ≥ 90% adhered (none to minimal lift)
≥ 75% adhered but < 90% (some edges showing lift)
≥ 50% adhered but < 75% (at least half of system lifts off)
< 50% (more than half of the patch lifts off, but the patch remains attached)
Patch completely detached."|1 year|Subjects that reported patch adhesion||Score||Standard Deviation|Mean
645943|NCT02158572|Other Pre-specified|Self-reported Skin Itching at Application Site|"Self-reported skin itching at application site was assessed using the following scoring method:
0: None
Mild
Moderate
Severe"|1 year|Subjects who reported itching at the application site||Score||Standard Deviation|Mean
645944|NCT02158572|Other Pre-specified|Self-reported Skin Irritation at Application Site|"Self-reported skin irritation at application site was assessed using the following scoring method:
0: None
Mild
Moderate
Severe"|1 year|Subjects who reported irritation at the application site.||Score||Standard Deviation|Mean
645945|NCT02158572|Secondary|Contraception Efficacy of AG200-15 in Subjects ≤ 35 Years of Age Regardless of BMI , PPI|"Contraception efficacy measured by Pearl Index. Pearl Index is the number of on-therapy pregnancies times 1300 divided by the number of 28-day on-therapy cycles and is an estimate of the number of pregnancies per 100 woman-years of product use.
PPI dataset: All complete or incomplete on-therapy cycles in which intercourse occurred, excluding the following two cohorts of cycles.
Cohort 1: cycles in which a back-up method of contraception was used for reasons other than the protocol-specified procedures for missed days of patch use, unless pregnancy occurred; and Cohort 2: cycles in which the subject missed ≥ 1 day of patch use and did not adhere to the recommended procedures for missed days of patch use.)"|1 year|PPI population||Pearl Index||95% Confidence Interval|Number
645946|NCT02158572|Secondary|Contraception Efficacy of AG200-15 in Subjects ≤ 35 Years of Age With BMI < 30 kg/m2, Per-Protocol-Instructions (PPI) Dataset|"Contraception efficacy measured by Pearl Index. Pearl Index is the number of on-therapy pregnancies times 1300 divided by the number of 28-day on-therapy cycles and is an estimate of the number of pregnancies per 100 woman-years of product use.
PPI Efficacy Dataset: All complete or incomplete on-therapy cycles in which intercourse occurred, excluding the following two cohorts of cycles.
Cohort 1: cycles in which a back-up method of contraception was used for reasons other than the protocol-specified procedures for missed days of patch use, unless pregnancy occurred; and Cohort 2: cycles in which the subject missed ≥ 1 day of patch use and did not adhere to the recommended procedures for missed days of patch use.)"|1 year|PPI population||Pearl Index||95% Confidence Interval|Number
645947|NCT02158572|Secondary|Contraception Efficacy of AG200-15 in Subjects ≤ 35 Years of Age With BMI < 30 kg/m2, ITT Dataset|Contraception efficacy of AG200-15 by Pearl Index in subjects ≤ 35 years of age with BMI < 30 kg/m2, ITT dataset. Pearl Index is the number of on-therapy pregnancies times 1300 divided by the number of 28-day on-therapy cycles and is an estimate of the number of pregnancies per 100 woman-years of product use.|1 year|ITT population: all complete or incomplete on-therapy cycles in which intercourse occurred and no back-up contraception was used.||Pearl Index||95% Confidence Interval|Number
646055|NCT02156271|Primary|Sleep Onset Latency (SOL) as Measured by Self Report (Sleep Diary)|The average of a week of sleep onset latency data from the sleep diary filled out in the morning by the participating subjects. Sleep latency is defined as the length of time it takes from lying down for the night until sleep onset.|Day 89-90|||minutes||Standard Deviation|Least Squares Mean
645948|NCT02158572|Primary|Contraception Efficacy of AG200-15 in Subjects ≤ 35 Years of Age Regardless of BMI, Intent-to-treat (ITT) Dataset.|The Pearl Index will serve as the primary contraceptive efficacy endpoint for evaluation of pregnancy rates for the study. Pearl Index is the number of on-therapy pregnancies times 1300 divided by the number of 28-day on-therapy cycles and is an estimate of the number of pregnancies per 100 woman-years of product use.|1 year|ITT population: all complete or incomplete on-therapy cycles in which intercourse occurred and no back-up contraception was used.||Pearl Index||95% Confidence Interval|Number
645949|NCT02158442|Primary|Efficacy of Timentin Delivered by PILP Procedure (Treatment Group) Versus Intravenous Delivery (Control Group) at Reducing Microbiological Load in Subjects With Diabetes, and Significant Wound Infection of the Lower Limb.|Reduction in microbiological load, including assessment of CFU, infection type and antibiotic sensitivity between the two groups over time. To compare the efficacy of Timentin delivered by PILP procedure (Treatment Group) versus intravenous delivery (Control Group) at reducing microbiological load in subjects with diabetes, and significant wound infection of the lower limb.|Day 3|"Treatment Group: 5 of the 5 analyzable microbiological loads resulted in a reduction. 1 was not analyzable.
Control Group: 3 of the 3 analyzable microbiological loads resulted in a reduction. 4 were not analyzable."||participants|||Number
645950|NCT02158273|Secondary|Change From Baseline in Standard Drinks Per Week at 1 Week|Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. Change = (Week 1 - Baseline). More negative values indicate less use of alcohol.|1 week|||drinks/week||Standard Deviation|Mean
645951|NCT02158273|Primary|Visual Analog Scale of Craving to Drink at 1 Week Following Administration of Fenofibrate or Placebo During the Double-Blind Period|The four Visual Analog Scale (VAS) questions assess domains of alcohol craving: the intention to drink, loss of control, relief craving, and urge intensity. Each VAS scale item score ranges from 1-20 where a one indicates no craving and 20 indicates severe craving; thus, a higher score indicates a worse outcome. Total is a summation of the four VAS item scores (i.e. Intent, Impulse, Relief, Strength) and ranges in value from 4-80 with higher scores indicative of a worse outcome.|1 week following administration of fenofibrate|||units on a scale||Standard Deviation|Mean
645952|NCT02158247|Primary|Airway Length vs Height in Female||Endotracheal intubation time|||Centimeters||Standard Deviation|Mean
645953|NCT02158247|Primary|Airway Length vs Height in Male||Endotracheal intubation time|||Centimeters||Standard Deviation|Mean
645954|NCT02158247|Secondary|Comparison Between Conventional Method and Touch and Read Method for Normal Group of Female|"Normal group is defined as the patients whose airway length from medial incisor to carina is over 23cm.
Conventional method : depth of intubation is 21cm at the medial incisor for female.
Touch and read method : depth of intubation is calculated as follow : length from mouth angle to epiglottis tip plus 11.5cm for female."|Endotracheal intubation time|||Centimeters||Standard Deviation|Mean
645955|NCT02158247|Secondary|Comparison Between Conventional Method and Touch and Read Method for Risk Group of Female|"Risk group is defined as the patients whose airway length from medial incisor to carina is below 23cm.
Conventional method : depth of intubation is 21cm at the medial incisor for female.
Touch and read method : depth of intubation is calculated as follow : length from mouth angle to epiglottis tip plus 11.5cm for female."|Endotracheal intubation time|||Centimeters||Standard Deviation|Mean
645956|NCT02158247|Secondary|Comparison Between Conventional Method and Touch and Read Method for Normal Group of Male|"Normal group is defined as the patients whose airway length from medial incisor to carina is over 25cm.
Conventional method : depth of intubation is 23cm at the medial incisor for male.
Touch and read method : depth of intubation is calculated as follow : length from mouth angle to epiglottis tip plus 12.5cm for male."|Endotracheal intubation time|||Centimeters||Standard Deviation|Mean
645957|NCT02158247|Secondary|Comparison Between Conventional Method and Touch and Read Method for Risk Group of Male|"Normal group is defined as the patients whose airway length from medial incisor to carina is below 25cm.
Conventional method : depth of intubation is 23cm at the medial incisor for male.
Touch and read method : depth of intubation is calculated as follow : length from mouth angle to epiglottis tip plus 12.5cm for male."|Endotracheal intubation time|||Centimeters||Standard Deviation|Mean
645958|NCT02158247|Primary|Comparison of Airway Length Between Male and Female|Airway length is defined the distance from medial incisor to carina. It is divided into four parts. It is medial incisor to mouth angle, mouth angle to epiglottis tip, epiglottis tip to vocal cords and vocal cords to carina.|Endotracheal intubation time|||Centimeters||Standard Deviation|Mean
645959|NCT02158039|Primary|Number of Subjects With Complete or Partial Ablation of the Treated Cyst|Complete or partial ablation of cysts will be defined by the presence of a persistent cystic structure, and its volume and maximum diameter, as determined by cross-sectional imaging studies (CT, MR)|1 year after final treatment|||participants|||Number
645960|NCT02158039|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Adverse events include pancreatitis, bleeding, perforation, any other occurrence resulting in hospitalization, medical treatment, surgery, death, or disability|1 year after final treatment|||participants|||Number
645961|NCT02157948|Secondary|Percent Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (P1NP)||Baseline, month 1, month 6 and month 12|"The bone turnover marker (BTM) efficacy analysis subset includes all randomized participants who had a baseline measurement and at least one post baseline measurement. n indicates the number of participants with available data at each time point."||percent change||Inter-Quartile Range|Median
645962|NCT02157948|Secondary|Percent Change From Baseline in Serum Type I Collagen C-telopeptide (sCTX)||Baseline, month 1, month 6 and month 12|"The bone turnover marker (BTM) efficacy analysis subset includes all randomized participants who had a baseline measurement and at least one post baseline measurement. n indicates the number of participants with available data at each time point."||percent change||Inter-Quartile Range|Median
645963|NCT02157948|Primary|Percent Change From Baseline in Lumbar Spine BMD|Lumbar spine bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.|Baseline and Month 12|The primary efficacy analysis subset included all randomized participants who had a baseline lumbar spine DXA BMD measurement and at least 1 postbaseline lumbar spine DXA BMD measurement. Postbaseline BMD values obtained at the early termination visit were carried forward as the month-12 value.||percent change||Standard Deviation|Mean
645964|NCT02157935|Secondary|Nights With Awakening Due to COPD|"Nighttime awakening due to COPD symptoms correspond to the severity of nocturnal symptoms from COPD.
The average number of awakening per night over the treatment period was analyzed. It was derived as the number of night with awakening divided by the total number of nights with data in the recording period. Change from baseline period on awakening was summarized and compared between two arms using a mixed model."|From Run-in W -4 to EoT W 26|The change from baseline on awakening were analyzed on randomized patients with a baseline and a post-baseline value. Among 1219 patients who were randomized, only 603 patients in Symbicort group and 610 patients in Formoterol group had valid data and included in analysis.||awakening/night||Standard Deviation|Mean
645965|NCT02157935|Secondary|Total Rescue Medication Use (Average Puffs/Day)|"Use of rescue medication is a measure of symptoms that need to be treated with a short-acting bronchodilator.
The average daily use across the observation period was used for analysis. Change from baseline was summarized and compared between two arms using a mixed model."|From Run-in W -4 to EoT W 26|The change from baseline on rescue medication use were analyzed on randomized patients with a baseline and a post-baseline value. Among 1219 patients who were randomized, only 602 patients in Symbicort group and 607 patients in Formoterol group had valid data and included in analysis.||puffs/day||Standard Deviation|Mean
645966|NCT02157935|Secondary|Pre-dose/Pre-bronchodilator FEV1 at the Study Site|FEV1 from pre-dose spirometry is a measurement of lung function. The change from baseline on pre-dose FEV1 was summarized and compared between Symbicort and Formoterol groups using a mixed model.|From Run-in W -4 to EoT W 26|The change from baseline in pre-dose FEV1 were analyzed on randomized patients with a baseline pre-dose FEV1 and at least one post-baseline value. Among 1219 patients who were randomized, only 588 patients in Symbicort group and 589 patients in Formoterol group had valid data and included in analysis.||L||Standard Deviation|Mean
645967|NCT02157935|Secondary|St. George’s Respiratory Questionnaire (SGRQ)|"SGRQ is a standardized, self-administered tool for measuring impaired health and perceived wellbeing in respiratory diseases; a validated electronic version of the questionnaire in the relevant validated languages was used in this study.
The questionnaire contains 50 items divided into three dimensions (Symptoms, Activity and Impact).
Each of the three dimensions of the questionnaire is scored separately in the range from 0 to 100:
zero (0) score indicating no impairment of quality of life.
The total SGRQ score ranging from 0 to 100 is a summary score utilizing responses to all items calculated using weights attached to each item of the questionnaire.
Higher scores indicate poorer health and change of 4 units in the SGRQ has been determined to be the threshold for a clinically relevant change in health status.
The change from baseline was statistically summarized and compared between two arms in a mixed model."|From Run-in W -4 to EoT W 26|The change from baseline in SGRQ were analyzed on randomized patients with a baseline SGRQ and at least one post-baseline value. Among 1219 patients who were randomized, only 589 patients in Symbicort group and 593 patients in Formoterol group had valid data and included in analysis.||scores on a scale||Standard Deviation|Mean
645968|NCT02157935|Secondary|Number of Patients With Moderate or Severe COPD Exacerbation.|"The number of patients who developed moderate or severe COPD exacerbation during treatment period were reported. Cox proportional hazards regression model was fitted to data to compare the two treatment arms .
The hazard ratio and 95% CI were estimated."|From randomzation to EoT W 26|||Participants|||Number
645969|NCT02157935|Primary|The Rate of Moderate and Severe COPD Exacerbations Defined as: Worsening of ≥2 Major Symptoms or Worsening of 1 Major Symptom Together With ≥1 Minor Symptom for ≥2 Consecutive Days|"The annual COPD exacerbation rate was analyzed and compared between two arms.
Annual exacerbation rate for each subject is defined as number of exacerbations divided by duration of randomized treatment period in years.
The annual COPD exacerbation rate of Symbicort group was compared with annual rate of Formoterol group. The rate ratio of Symbicort vs. Formoteroal was assessed by a negative binomial model.
Exacerbations, that met the modified Anthonisen criteria and duration ≥2 days were classified as moderate and severe exacerbations.
Moderate exacerbation: treatment of symptoms with systemic corticosteroids (≥3 days) and/or antibiotics.
Severe exacerbation: symptoms that require hospitalization (including >24 hours in ED/urgent care setting)."|Randomization at Week 0 to End of Treatment (EoT) W 26|Full analysis set including all randomized subjects||COPD exacerbations per year||95% Confidence Interval|Least Squares Mean
645970|NCT02157909|Primary|Proportion of Subjects Satisfying the 'no Re-fit' Criteria in Both Eyes|With the contact lens on eye, the investigator assessed the lens fit immediately post-blink and following lower lid margin push-up with the lower lid using a 5-point scale, where -2 = Unacceptably tight (reduced movement, unacceptable), -1 = Acceptably tight (reduced movement, acceptable), 0 = Optimal fit / movement, +1 = Acceptably loose (excessive movement, acceptable), and +2 = Unacceptably loose (excessive movement, unacceptable). To meet the definition of “no re-fit,” an eye had to have an acceptable or optimal overall lens fit with the study lens, as well as be within 1 grade of the overall lens fit assessed with the habitual lens at baseline. Proportion of subjects is reported as a percentage.|Dispense (Day 0), Week 1|This analysis population includes all randomized and treated subjects.||percentage of subjects|||Number
645971|NCT02157883|Secondary|AUC of AZ7550|Pharmacokinetics of AZ7550 (metabolite to AZD9291) by assessment of area under the plasma concentration time curve from zero to infinity|Blood samples collected on Day 1 and Day 10 at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, and 216 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine outcome measure without important protocol deviations, where AUC possible to calculate, and including Period 2 data (all patients met carry over criteria of Period 2 pre-dose AZ7550 concentration >20% of Cmax).||nM*h||Full Range|Geometric Mean
645972|NCT02157883|Secondary|Cmax of AZ7550|Pharmacokinetics of AZ7550 (metabolite to AZD9291) by assessment of maximum plasma AZ7550 concentration|Blood samples collected on Day 1 and Day 10 at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, and 216 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine outcome measure without important protocol deviations/violations and including Period 2 data (since all patients met carry over criteria of Period 2 pre-dose AZ7550 concentration >20% of Cmax).||nM||Full Range|Geometric Mean
646088|NCT02155322|Primary|Percentage of Participants Discontinuing Study Drug Because of AEs|An adverse event was any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.|From first dose to last dose of treatment; up to 12 months|All participants who received at least one dose of study drug.||Percentage of participants|||Number
645973|NCT02157883|Secondary|AUC of AZ5104|Pharmacokinetics of AZ5104 (metabolite to AZD9291) by assessment of area under the plasma concentration time curve from zero to infinity|Blood samples collected on Day 1 and Day 10 at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, and 216 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine outcome measure without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose AZ5104 concentration >20% of Cmax).||nM*h||Full Range|Geometric Mean
645974|NCT02157883|Secondary|Cmax of AZ5104|Pharmacokinetics of AZ5104 (metabolite to AZD9291) by assessment of maximum plasma AZ5104 concentration|Blood samples collected on Day 1 and Day 10 at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, and 216 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine outcome measure without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose AZ5104 concentration >20% of Cmax).||nM||Full Range|Geometric Mean
645975|NCT02157883|Secondary|Vz/F of AZD9291|Rate and extent of absorption of AZD9291 by assessment of the apprarent volume of distribution|Blood samples collected on Day 1 and Day 10 at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, and 216 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine outcome measure without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >10% of Cmax).||L||Full Range|Geometric Mean
645976|NCT02157883|Secondary|CL/F of AZD9291|Rate and extent of absorption of AZD9291 by assessment of apparent clearance following oral administration|Blood samples collected on Day 1 and Day 10 at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, and 216 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine outcome measure without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >10% of Cmax).||L/h||Full Range|Geometric Mean
645977|NCT02157883|Secondary|t1/2 of AZD9291|Pharmacokinetics of AZD9291 by assessment of the terminal half-life|Blood samples collected on Day 1 and Day 10 at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, and 216 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine outcome measure without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >10% of Cmax).||hours||Full Range|Geometric Mean
645978|NCT02157883|Secondary|Tmax of AZD9291|Pharmacokinetics of AZD9291 by assessment of time to Cmax|Blood samples collected on Day 1 and Day 10 at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, and 216 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine outcome measure without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >10% of Cmax).||hours||Full Range|Median
645979|NCT02157883|Secondary|AUC(0-t) of AZD9291|Pharmacokinetics of AZD9291 by assessment of area under the plasma concentration curve from time zero to last quantifiable dose|Blood samples collected on Day 1 and Day 10 at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, and 216 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine outcome measure without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >10% of Cmax).||nM*h||Full Range|Geometric Mean
645980|NCT02157883|Secondary|AUC(0-120) of AZD9291|Pharmacokinetics of AZD9291 by assessment of area under the plasma concentration time curve from zero to 120 hours|Blood samples collected on Day 1 and Day 10 at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, and 216 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine outcome measure without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >10% of Cmax).||nM*h||Full Range|Geometric Mean
645981|NCT02157883|Primary|AUC of AZD9291|Pharmacokinetics of AZD9291 by assessment of area under the plasma concentration time curve from zero to infinity|Blood samples collected on Day 1 and Day 10 at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, and 216 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine outcome measure without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >10% of Cmax).||nM*h||Full Range|Geometric Mean
645982|NCT02157883|Primary|Cmax of AZD9291|Pharmacokinetics of AZD9291 by assessment of maximum plasma AZD9291 concentration|Blood samples collected on Day 1 and Day 10 at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, and 216 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine outcome measure without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >10% of Cmax).||nM||Full Range|Geometric Mean
645983|NCT02157623|Secondary|Patient Satisfaction Survey|Overall patient satisfaction with the technique will be assessed using a simple survey.|6 months||||||
645984|NCT02157623|Secondary|Pain Score on a Visual-Analog Scale|Tolerability, defined as pain during treatment using Red light versus Blue light PDT, will be assessed.|6 months||||||
645985|NCT02157623|Primary|Tumor Clearance Rate|The rate of clearance of existing BCC tumors will be assessed in patients with BCNS, using clinical and photographic measurements. The endpoint will be assessed for tumors in a Red light treatment field and a Blue light treatment field in each patient, and compared.|6 months|study terminated, no outcomes|||||
646034|NCT02156466|Primary|MSB0010841 Serum Concentration Over Time After Second Dose||0 hours (pre-dose), 24, 72, 96, 168, 336 hours post-second dose (Day 15)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure at the specified time points.||ng/mL||Standard Deviation|Mean
645986|NCT02157376|Secondary|Proportion of Patients With Any Overt Upper-GI Bleeding (Significant and Non-significant) During the Treatment Evaluation Phase|"Criteria for a significant upper GI bleeding as described in primary outcome measure or,
Criteria for a non-significant upper GI bleeding as:
Bright red blood per NG or OG tube that clear after NG or OG tube adjustment and 5 to 10 minutes of lavage with room temperature normal saline or,
Persistent gastroccult- positive coffee ground material
During IMP treatment Day 1-2:
Persistent gastroccult - positive coffee ground material for at less than eight consecutive hours or that clear with at least 100 ml of lavage with room temperature normal saline.
During IMP treatment Day 3-14:
Persistent gastroccult - positive coffee ground material in less than three consecutive gastric aspirates within 2 to 4 hours (at least 60±20 minutes apart), or that clear with at least 100 ml of lavage with room temperature normal saline or,
Any clinical signs of hematemesis or melena or haematochezia judged (by the Investigator) to be from an upper GI source."|1-14 days|Full analysis set (FAS). All randomized patients in whom at least one dose of randomized treatment has been initiated.||proportion of participants|||Number
645987|NCT02157376|Primary|The Percent of Patients With Clinically Significant Upper-GI Bleeding During the Treatment Evaluation Phase|"Criteria for a clinically significant upper GI bleeding as:
Bright red blood per NG or OG tube that did not clear after NG or OG tube adjustment and 5 to 10 minutes of at least 100 ml lavage with room temperature normal saline-or,
Persistent gastroccult- positive coffee ground material
During IMP treatment Day 1-2:
Persistent gastroccult- positive coffee ground material for at least eight consecutive hours that did not clear with at least 100 ml of lavage with room temperature normal saline.
During IMP treatment Day 3-14:
Persistent gastroccult- positive coffee ground material in at least three consecutive gastric aspirates within 2 to 4 hours (at least 60 ±20 minutes apart), that did not clear with at least 100 ml of lavage with room temperature normal saline."|1-14 days|Full analysis set (FAS). All randomized patients in whom at least one dose of randomized treatment has been initiated.||% of participants|||Number
645988|NCT02157298|Secondary|Proportion of Participants With Mean Daily Insulin Dose Reduction of Greater Than or Equal 10%|Proportion of participants with mean daily insulin dose reduction greater than or equal 10% from baseline to week 16 (LOCF) between dapagliflozin 5 mg versus placebo|Baseline to Week 16|Full Analysis Set, participants with non-missing baseline and Week 16 (LOCF) value||percentage of participants||95% Confidence Interval|Least Squares Mean
645989|NCT02157298|Secondary|Total Mean Daily Insulin Dose|Mean change in calculated mean daily insulin dose from baseline to Week 16 between dapagliflozin 5 mg versus placebo|Baseline to Week 16|Full Analysis Set, participants with non-missing baseline and at least one post-baseline value up to week 16||IU/Day||95% Confidence Interval|Least Squares Mean
645990|NCT02157298|Secondary|Total Body Weight|Mean change in total body weight from baseline to Week 16 between dapagliflozin 5 mg versus placebo|Baseline to Week 16|Full Analysis Set, participants with non-missing baseline and at least one post-baseline value up to week 16||kg||95% Confidence Interval|Least Squares Mean
645991|NCT02157298|Secondary|Fasting Plasma Glucose|Mean change in fasting plasma glucose from baseline to Week 16 between dapagliflozin 5 mg versus placebo|Baseline to Week 16|Full Analysis Set, participants with non-missing baseline and at least one post-baseline value up to week 16||mg/dL||95% Confidence Interval|Least Squares Mean
645992|NCT02157298|Primary|Adjusted Mean Change in HbA1c Levels|Mean change in HbA1c levels from baseline to Week 16 between dapagliflozin 5 mg versus placebo|Baseline to Week 16|Full Analysis Set, participants with non-missing baseline and at least one post-baseline value up to week 16||percentage of hemoglobin glycosylated||95% Confidence Interval|Least Squares Mean
645993|NCT02157116|Secondary|Overall Survival||Approximately 10 years|Due to insufficient accrual, the study was stopped prior to completing the 10 year followup for survival.|||||
645994|NCT02157116|Secondary|Number of Patients Who Were Able to Maintain Hemoglobin Between 11-13 g/dL During Induction||During induction, approximately 6 weeks|Due to insufficient accrual, data analysis was not performed.|||||
645995|NCT02157116|Secondary|Number of Grade III/IV Non-hematologic Adverse Events||During induction chemotherapy, approximately 6 weeks|Due to insufficient accrual, data analysis was not performed.|||||
645996|NCT02157116|Secondary|Number of Grade III/IV Hematologic Adverse Events||During induction chemotherapy, approximately 6 weeks|Due to insufficient accrual, data analysis was not performed.|||||
645997|NCT02157116|Primary|Differential Gene Expression Between Responsive and Resistant Tumor Treated With Dose-dense Therapy||at the end of the study, estimated 2.5 years|Due to insufficient accrual, gene analysis was not performed.|||||
645998|NCT02157116|Primary|Induction Response|Response will be assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Response is defined as the number patients with a Complete Response (CR), disappearance of all target lesions, or a Partial Response (PR), at least a 30% decrease in the sum of the longest diameter (LD) of target lesions.|Between 2 and 3 weeks after induction|Due to insufficient accrual, data analysis was not performed.|||||
645999|NCT02156466|Secondary|Percentage of Subjects With Exacerbation of Psoriasis|Psoriasis exacerbation was defined as either a worsening of 25% over the baseline value of the PASI score (PASI score at any visit >=125% of baseline PASI).|Baseline up to Day 85|Safety analysis set included all 41 subjects who received at least 1 dose of IMP (MSB0010841 or placebo).||percentage of subjects|||Number
646000|NCT02156466|Secondary|Mean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85|The BSA is the physician’s evaluation for the extent of disease. The entire body area is divided into 4 districts: head, upper limbs, trunk and lower limbs to which corresponds the 10%, 20%, 30% and 40% of the entire body surface respectively. The investigator assesses the percentage of the subjects' body surface area affected by psoriasis in each district. The final affected BSA value is the sum of the percentage of each district.|Baseline, Day 8, 15, 22, 29, 36, 43, 50 and 85|"Safety analysis set included all 41 subjects who received at least 1 dose of IMP (MSB0010841 or placebo). Here n signifies those subjects who were evaluable for this outcome measure at the specified time points."||percent change||Standard Deviation|Mean
646021|NCT02156466|Primary|Average Concentration (Cav) Post First Dose of MSB0010841|Cav was calculated by AUCtau/tau. Where tau is the dosing interval (336 hours).|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
646001|NCT02156466|Secondary|Percentage of Subjects With Static Physician’s Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From Baseline|The static Physician’s Global Assessment (sPGA) scale rated the investigator’s overall clinical assessment of a subjects plaque thickness, erythema, and scaling on a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (majority of plaques have severe thickness, erythema, and scale). To assign a sPGA score, the investigator examined all psoriatic lesions and assigned a severity score ranging from 0 to 5 for thickness, erythema, and scaling. Scores for thickness, erythema, and scaling are summed and the mean of these 3 scores equals the overall sPGA score. Overall sPGA score ranged from 0 to 5, where lower scores indicate clinical improvement. Percentage of subjects who achieved a sPGA rating of 0 (clear) or 1 (minimal) and had at Least 2 level reduction from Baseline score were reported.|Day 8, 15, 22, 29, 36, 43, 50, 85|Safety analysis set included all 41 subjects who received at least one dose of IMP (MSB0010841 or placebo).||percentage of subjects|||Number
646002|NCT02156466|Secondary|Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Day 43|PASI: a physician assessed index that measured psoriasis severity and evaluated erythema, infiltration, and desquamation (scaling) on different body areas including the head, upper extremities, the trunk, and lower extremities. T Erythema, infiltration, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. These values for each anatomic region are summed to yield the PASI score. PASI score ranged from 0 to 72, with higher scores reflecting greater disease severity. PASI 50% or 75% was defined as the percentage of subjects who achieved >=50 or 75% improvement in PASI score from Baseline.|Baseline, Day 43|Safety analysis set included all 41 subjects who received at least one dose of IMP (MSB0010841 or placebo).||units on a scale||Standard Deviation|Mean
646003|NCT02156466|Secondary|Percentage of Subjects With 50% or 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score|PASI: a physician assessed index that measured psoriasis severity and evaluated erythema, infiltration, and desquamation (scaling) on different body areas including the head, upper extremities, the trunk, and lower extremities. T Erythema, infiltration, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. These values for each anatomic region are summed to yield the PASI score. PASI score ranged from 0 to 72, with higher scores reflecting greater disease severity. PASI 50% or 75% was defined as the percentage of participants who achieved >=50 or 75% improvement in PASI score from Baseline.|Baseline up to Day 85|Safety analysis set included all 41 subjects who received at least 1 dose of IMP (MSB0010841 or placebo).||percentage of subjects|||Number
646004|NCT02156466|Primary|Observed Serum Concentration Immediately Before Second Dose (Cpre) of MSB0010841|The observed serum concentration immediately before second dose.|Pre-dose (0 hours) on Day 15|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
646005|NCT02156466|Primary|Maximum Observed Concentration (Cmax) Post Second Dose of MSB0010841||0 hours (pre-dose), 24, 72, 96, 168, 336 hours post-second dose (Day 15)|"PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here Number of subjects analyzed signifies those subjects who were evaluable for this outcome measure."||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
646006|NCT02156466|Primary|Accumulation Ratio of AUC (Racc(AUC))|Accumulation ratio for AUC, calculated as area under the serum concentration-time curve within one complete dosing interval at third dose divided by area under the serum concentration-time curve within one complete dosing interval at first dose.|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1) and 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.||ratio||Geometric Coefficient of Variation|Geometric Mean
646007|NCT02156466|Primary|Accumulation Ratio of Cmax (Racc (Cmax))|Accumulation ratio for Cmax was calculated as Cmax, after third dose / Cmax, after first dose.|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1) and 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.||ratio||Geometric Coefficient of Variation|Geometric Mean
646008|NCT02156466|Primary|Percentage Peak-Trough Fluctuation (PTF) Post Third Dose of MSB0010841|The peak trough fluctuation within one dosing interval, calculated as PTF (%) = ([Cmax - Cmin]/Cav ) multiplied by 100|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)|"PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here Number of subjects analyzed signifies those subjects who were evaluable for this outcome measure."||percentage fluctuation||Geometric Coefficient of Variation|Geometric Mean
646009|NCT02156466|Primary|Percentage Peak-Trough Fluctuation (PTF) Post First Dose of MSB0010841|The peak trough fluctuation within one dosing interval, calculated as PTF (%) = ([Cmax - Cmin]/Cav ) multiplied by 100|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)|"PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here Number of subjects analyzed signifies those subjects who were evaluable for this outcome measure."||percentage fluctuation||Geometric Coefficient of Variation|Geometric Mean
646310|NCT02149875|Primary|National Institutes of Health Stroke Scale Score|Scores range from 0 to 42, with higher scores indicating increasing severity|At 11-day and 21-day after therapy|||units on a scale||Standard Deviation|Mean
646010|NCT02156466|Primary|Apparent Volume of Distribution During Terminal Phase (Vz/f) Post Third Dose of MSB0010841|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/AUC0-inf multiplied by elimination rate constant [λz]) following first dose and Dose/(AUCtau multiplied by λz) after third dose.|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)|"PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here Number of subjects analyzed signifies those subjects who were evaluable for this outcome measure."||Liters||Geometric Coefficient of Variation|Geometric Mean
646011|NCT02156466|Primary|Apparent Clearance (CL/f) Post Third Dose of MSB0010841|Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent clearance after oral dose (CL/f) is influenced by the fraction absorbed.|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.||L/day||Geometric Coefficient of Variation|Geometric Mean
646012|NCT02156466|Primary|Terminal Rate Constant (λz) Post Third Dose of MSB0010841|Terminal rate constant was determined from the terminal slope of the logtransformed concentration curve using linear regression on terminal data points of the curve|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.||1/hour||Geometric Coefficient of Variation|Geometric Mean
646013|NCT02156466|Primary|Apparent Terminal Half-life (t1/2) Post Third Dose of MSB0010841|Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life is calculated by dividing the natural logarithm to the base e (Log e) multiplied by (*) 2/ λz, where ‘λz’ is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.||day||Geometric Coefficient of Variation|Geometric Mean
646014|NCT02156466|Primary|Time to Reach Maximum Observed Concentration (Tmax) Post Third Dose of MSB0010841||0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.||hour||Full Range|Median
646015|NCT02156466|Primary|Time to Maximum Observed Concentration (Tmax) Post Second Dose of MSB0010841||0 hours (pre-dose), 24, 72, 96, 168, 336 hours post-second dose (Day 15)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.||hour||Full Range|Median
646016|NCT02156466|Primary|Time to Reach Maximum Observed Concentration (Tmax) Post First Dose of MSB0010841||0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.||hour||Full Range|Median
646017|NCT02156466|Primary|Mean Residence Time of Drug in the Body From Time Zero Extrapolated to Infinity (MRT(0-inf) Post Third Dose of MSB0010841|Mean residence time of drug in the body from time zero extrapolated to infinity, based on the last predicted concentration at tlast.|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.||day||Geometric Coefficient of Variation|Geometric Mean
646018|NCT02156466|Primary|Mean Residence Time (MRT0-t) Post Third Dose of MSB0010841|MRT is the average time at which the number of absorbed molecules reside in the body, after single-dose administration, and calculated as AUMC(0-t)/AUC(0-t) where AUMC(0-t) is area under the plasma concentration-time first moment curve from time zero to time t (336 hours) and AUC(0-t) is the area under the plasma concentration-time curve from time zero to tome t (336 hours).|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-third dose (Day 29)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.||day||Geometric Coefficient of Variation|Geometric Mean
646019|NCT02156466|Primary|Mean Residence Time (MRT0-t) Post First Dose of MSB0010841|MRT is the average time at which the number of absorbed molecules reside in the body, after single-dose administration, and calculated as AUMC(0-t)/AUC(0-t) where AUMC(0-t) is area under the plasma concentration-time first moment curve from time zero to time t (336 hours) and AUC(0-t) is the area under the plasma concentration-time curve from time zero to tome t (336 hours).|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.||day||Geometric Coefficient of Variation|Geometric Mean
646020|NCT02156466|Primary|Average Concentration (Cav) Post Third Dose of MSB0010841|Cav was calculated by AUCtau/tau. Where tau is the dosing interval (336 hours).|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
646022|NCT02156466|Primary|Maximum Concentration Observed (Cmax) Post Third Dose of MSB0010841||0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
646023|NCT02156466|Primary|Maximum Concentration Observed (Cmax) Post First Dose of MSB0010841||0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
646024|NCT02156466|Primary|Minimum Concentration Observed (Cmin) During Third Dosing Interval of MSB0010841|The observed minimum serum concentration determined directly from the serum concentration-time profile of each subject.|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.||mcg/mL||Standard Deviation|Mean
646025|NCT02156466|Primary|Minimum Concentration Observed (Cmin) During First Dosing Interval of MSB0010841|The observed minimum serum concentration determined directly from the serum concentration-time profile of each subject.|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.||mcg/mL||Standard Deviation|Mean
646026|NCT02156466|Primary|Observed Serum Concentration Immediately Before Third Dose (Cpre) of MSB0010841|The observed serum concentration immediately before the third dose.|Pre-dose (0 hours) on Day 29|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.||mcg/mL||Standard Deviation|Mean
646027|NCT02156466|Primary|Observed Serum Concentration Immediately Before First Dose (Cpre) of MSB0010841|The observed serum concentration immediately before the first dose.|Pre-dose (0 hours) on Day 1|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.||mcg/mL||Standard Deviation|Mean
646028|NCT02156466|Primary|Area Under the Concentration-time Curve From Time Zero to Infinity (AUC 0-inf) Post Third Dose of MSB0010841|Area under the serum concentration-time curve from time zero to infinity (AUC0-inf). AUC0-infcalculated as AUC0-t + AUCextra. AUCextra represents the extrapolated part of AUC0-inf calculated by Clast calc/λz, where Clast calc is the calculated concentration at the last sampling time point at which the measured concentration is at or above LLOQ and λz is the terminal rate constant determined from the terminal slope of the log transformed concentration curve using linear regression on terminal data points of the curve.|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.||day*ug/mL||Geometric Coefficient of Variation|Geometric Mean
646029|NCT02156466|Primary|Area Under the Concentration-Time Curve From Time Zero up to Time Tau (AUCtau) Post Third Dose of MSB0010841|Area under the concentration-time curve from time zero up to time Tau, where Tau is the dosing interval (336 hours).|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-third dose (Day 29)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.||day*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
646030|NCT02156466|Primary|Area Under the Concentration-Time Curve From Time Zero up to Time Tau (AUCtau) Post First Dose of MSB0010841|Area under the concentration-time curve from time zero up to time Tau, where Tau is the dosing interval (336 hours).|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.||day*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
646031|NCT02156466|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) Post Third Dose of MSB0010841|Area under the serum concentration-time curve (AUC) from time zero to the last sampling time point at which the concentration is at or above LLOQ.|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.||day*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
646032|NCT02156466|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) Post First Dose of MSB0010841|Area under the serum concentration-time curve (AUC) from time zero to the last sampling time point at which the concentration is at or above lower limit of quantification (LLOQ).|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.||day*microgram per milliliter (day*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
646033|NCT02156466|Primary|MSB0010841 Serum Concentration Over Time After Third Dose||0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure at the specified time points.||ng/mL||Standard Deviation|Mean
646035|NCT02156466|Primary|MSB0010841 Serum Concentration Over Time After First Dose||0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)|PK analysis set included subjects who received first dose of MSB0010841 without protocol deviations affecting PK, and who provide evaluable PK data. Here “n” signifies those subjects who were evaluable for this outcome measure at the specified time points.||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
646036|NCT02156466|Primary|Levels of Pre-existing Anti-MSB0010841 Antibody Titers||Pre-dose on Day 1|All subjects who received placebo or MSB0010841 (30 mg, 60 mg, 90 mg or 240 mg) and had positive ADA titers before and/or after study drug administration were included in the analysis population.||log10titer|||Number
646037|NCT02156466|Primary|Levels of Anti-MSB0010841 Antibody Titers||Day 8, 15 (pre-dose), 22, 29 (pre-dose), 36, 43, 63 and 85|All subjects who received placebo or MSB0010841 (30 mg, 60 mg, 90 mg or 240 mg) and had positive ADA titers before and/or after study drug administration were included in the analysis population.||log10titer|||Number
646038|NCT02156466|Primary|Percentage of Subjects With Anti-MSB0010841 Binding Antibodies (Anti-Drug Antibodies [ADA])|Data were presented for MSB0010841 combined group and placebo.|Baseline up to Day 85|Safety analysis set included all 41 subjects who received at least one dose of IMP (MSB0010841 or placebo).||percentage of subjects|||Number
646039|NCT02156466|Primary|Amount of Pain at Injection Site Assessed By Visual Analog Scale (VAS)|Subjects were asked to assess their severity of injection site pain on a 100 millimeter (mm) VAS, where 0 = no pain and 100 = worst possible pain. Mean of amount of pain was calculated for the subjects having a value > 0. Maximum values per subjects (over injection site areas) are used for counting the amount of pain at injection site. Maximum pain scores recorded among all participants analysed in each arm are reported for each time point.|Day 1, 2, 8, 15, 16, 22, 29, 30, 36, 43|Safety analysis set included all 41 subjects who received at least one dose of IMP (MSB0010841 or placebo). Here “Number of subjects analyzed” signifies those subjects who were evaluable for this endpoint and “n” signifies those subjects who were evaluable at the specified time point.||mm|||Number
646040|NCT02156466|Primary|Number of Subjects With Local Injection Site Reactions (ISRs)|The injection site was assessed by the Principal Investigator (PI) or his/her designee for local reactions such as redness, swelling, indurations or bruising, and by the subject for itching. Redness and bruising were scaled as None (no visible redness or bruising present); Mild (less than or equal to [<=] 2.0 centimeters [cm] redness or bruising area); Moderate (greater than [>] 2 to <=5.0 cm redness or bruising area); Severe (>5.0 cm redness or bruising area). Swelling was scaled as None (no swelling detected); Mild (palpable ‘firmness’ only); Moderate (<= 4 cm swelling); Severe (>4 cm swelling). Induration was scaled as None (no induration); Mild (able to move skin parallel to plane (sliding) and perpendicular to skin (pinching up); Moderate (able to slide skin, unable to pinch skin); Severe (unable to slide or pinch skin). Itching was scaled as No itching; Mild itching; Moderate itching and Severe itching. Subjects who reported any of the local ISRs were reported.|Day 1, 2,8, 15, 16, 22, 29, 30, 36, 43|Safety analysis set included all 41 subjects who received at least one dose of IMP (MSB0010841 or placebo). Here “n” signifies those subjects who were evaluable for the specified injection site reaction. Subjects may be represented in more than 1 category.||subjects|||Number
646041|NCT02156466|Primary|Number of Subjects With Treatment Emergent Adverse Events (TEAEs)|An adverse event (AE) was defined as any untoward medical occurrence which does not necessarily have a causal relationship with this the study drug. An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug. TEAEs were the AEs occurring or worsening after treatment administration.|Baseline up to Day 85|Safety analysis set included all 41 subjects who received at least 1 dose of IMP (MSB0010841 or placebo).||subjects|||Number
646042|NCT02156271|Secondary|Interleukin 6 (IL-6)||Baseline|||pg/mL||Standard Deviation|Mean
646043|NCT02156271|Secondary|Insulin Resistance (IR)|In each subject, an insulin resistance score based on Homeostasis Model Assessment (HOMA-IR) was estimated at baseline. Formula: fasting plasma glucose (mmol/l) times fasting serum insulin (mU/l) divided by 22.5. Low HOMA-IR values indicate high insulin sensitivity, whereas high HOMA-IR values indicate low insulin sensitivity (insulin resistance).|Baseline|||HOMA-IR value||Standard Deviation|Mean
646044|NCT02156271|Secondary|Inflammatory Biomarkers C-reactive Protein (CRP)||Baseline|||mg/L||Standard Deviation|Mean
646045|NCT02156271|Primary|Sleep Onset Latency (SOL) as Measured by Self Report (Sleep Diary)|The average of a week of sleep onset latency data from the sleep diary filled out in the morning by the participating subjects.|Baseline|||minutes||Standard Deviation|Mean
646046|NCT02156271|Primary|Mean Latency to Persistent Sleep (LPS) Via Polysomnography|Elapsed time from the beginning of the Polysomnography recording to the onset of the first 20 minutes of continuous sleep was measured.|Baseline|||minutes||Standard Deviation|Mean
646047|NCT02156271|Primary|Sleep Onset Latency (SOL) as Measured by Pittsburgh Sleep Qualtiy Index (PSQI)|Subjects completed component 2 of the PSQI questionnaire. Component 2 asks questions about sleep latency and is scored on a scale from 0 (better) to 3 (worse).|day 89 - 90|||units on a scale||Standard Deviation|Least Squares Mean
646048|NCT02156271|Secondary|Insulin Resistance (IR)|In each subject, an insulin resistance score based on Homeostasis Model Assessment (HOMA-IR) was estimated at day 89-90. Formula: fasting plasma glucose (mmol/l) times fasting serum insulin (mU/l) divided by 22.5. Low HOMA-IR values indicate high insulin sensitivity, whereas high HOMA-IR values indicate low insulin sensitivity (insulin resistance).|Day 89-90|||HOMA-IR value||Standard Deviation|Least Squares Mean
646049|NCT02156271|Secondary|Interleukin 6 (IL-6)||Day 89-90|||pg/mL||Standard Deviation|Least Squares Mean
646050|NCT02156271|Secondary|Inflammatory Biomarkers C-reactive Protein (CRP)||Day 89-90|||ng/mL||Standard Deviation|Least Squares Mean
646051|NCT02156271|Secondary|Change in Total Sleep Time|Change in sleep time will be determined by PSG.|Day -1-0, Day 89-90|Data was not collected, and therefore not analyzed.|||||
646052|NCT02156271|Primary|Sleep Onset Latency (SOL) as Measured by Pittsburgh Sleep Qualtiy Index (PSQI)|Subjects completed component 2 of the PSQI questionnaire. Component 2 asks questions about sleep latency and is scored on a scale from 0 (better) to 3 (worse).|baseline|||units on a scale||Standard Deviation|Mean
646053|NCT02156271|Primary|Change in Metabolic Syndrome (MetSyn)||Baseline, Day 30, Day 60, Day 89-90|Data was not collected, and therefore not analyzed.|||||
646056|NCT02156167|Primary|Aided Speech Reception Threshold (SRT) in Noise Measured by Signal to Noise Ratio for 50% Correct Scores With the Oldenburger Sentence Test|"The Oldenburger Sentence test is an adaptive speech in noise test with a fixed noise level of typically 65 decibel (dB) sound pressure level (SPL) and a varying speech level, depending on how many words in a sentence were repeated correctly by the subject. The outcome of this test is the signal-to-noise ratio (SNR) at which 50% of words in the sentence list were correctly repeated by the subject. The SRT in noise with the Freedom sound processor at the initial study visit was compared to the SRT in noise with the CP810 at the 3 months follow-up at different measurement conditions.
Speech and noise coming from the front (S0N0)- Speech coming from the front and noise coming from the implanted side (S0N90)- Everyday program (E): omnidirectional microphone- Noise program (N): directional microphone- Freedom Sound Processor (Freedom)- CP810 Sound Processor (CP810)."|3 months after initial upgraded fitting|One subject did not visit the clinic for the 3 months follow-up, a second subject did not perform the speech in noise test at the 3 months follow-up due to tiredness||dB SNR||Standard Deviation|Mean
646057|NCT02155985|Secondary|Change in Brachial Artery Flow-mediated Dilation (FMD) From Entry to Week 12|Absolute change was calculated as the value at week 12 minus the value at entry.|Entry to Week 12|Analysis used the per-protocol population as in the primary analyses.||percentage of brachial artery diameter||95% Confidence Interval|Mean
646058|NCT02155985|Secondary|Change in Urine Thromboxane Per Creatinine From Entry to Week 12|Absolute change was calculated as the value at week 12 minus the value at entry.|Entry to Week 12|Analysis used the per-protocol population as in the primary analyses.||fold change||95% Confidence Interval|Mean
646059|NCT02155985|Secondary|Change in Serum Thromboxane B2 From Entry to Week 12|Absolute change was calculated as the value at week 12 minus the value at entry.|Entry to Week 12|Analysis used the per-protocol population as in the primary analyses.||fold change||95% Confidence Interval|Mean
646060|NCT02155985|Secondary|Change in Kynurenine to Tryptophan Ratio From Entry to Week 12|Absolute change was calculated as the value at week 12 minus the value at entry.|Entry to Week 12|Analysis used the per-protocol population as in the primary analyses.||1000 ng/ml kynurenine : ng/ml tryptophan||95% Confidence Interval|Mean
646061|NCT02155985|Secondary|Change in D-dimer From Baseline to Week 11/12|"Baseline is defined as the average of the Pre-Entry and Entry values. Week 11/12 is defined as the average of the Week 11 and Week 12 values. All values were log10 transformed prior to calculating change and conducting analyses. Values obtained within 6 days after the influenza vaccination were excluded.
Absolute change was calculated as the value at week 11/12 minus the value at baseline. Mean changes were exponentiated to be back on the untransformed scale and corresponds to a mean fold change."|Pre-entry and entry to weeks 11 and 12|Analysis used the per-protocol population as in the primary analyses.||fold change||95% Confidence Interval|Mean
646062|NCT02155985|Secondary|Change in IL-6 From Baseline to Week 11/12|"Baseline is defined as the average of the Pre-Entry and Entry values. Week 11/12 is defined as the average of the Week 11 and Week 12 values. All values were log10 transformed prior to calculating change and conducting analyses. Values obtained within 6 days after the influenza vaccination were excluded.
Absolute change was calculated as the value at week 11/12 minus the value at baseline. Mean changes were exponentiated to be back on the untransformed scale and corresponds to a mean fold change."|Pre-entry and entry to weeks 11 and 12|Analysis used the per-protocol population as in the primary analyses.||fold change||95% Confidence Interval|Mean
646063|NCT02155985|Secondary|Change in Expression of PD-1+ on CD8+ From Entry to Week 12|Absolute change was calculated as the value at week 12 minus the value at entry.|Entry to Week 12|Analysis used the per-protocol population as in the primary analyses.||percentage of CD8+ expressing PD-1+||95% Confidence Interval|Mean
646064|NCT02155985|Secondary|Change in Expression of PD-1+ on CD4+ From Entry to Week 12|Absolute change was calculated as the value at week 12 minus the value at entry.|Entry to Week 12|Analysis used the per-protocol population as in the primary analyses.||percentage of CD4+ expressing PD-1+||95% Confidence Interval|Mean
646065|NCT02155985|Secondary|Change in Expression of CD38+HLA-DR+ on CD8+ From Entry to Week 12|Absolute change was calculated as the value at week 12 minus the value at entry.|Entry to Week 12|Analysis used the per-protocol population as in the primary analyses.||percent of CD8+ expressing CD38+HLA-DR+||95% Confidence Interval|Mean
646066|NCT02155985|Secondary|Change in Expression of CD38+HLA-DR+ on CD4+ From Entry to Week 12|Absolute change was calculated as the value at week 12 minus the value at entry.|Entry to Week 12|Analysis used the per-protocol population as in the primary analyses.||percent of CD4+ expressing CD38+HLA-DR+||95% Confidence Interval|Mean
646067|NCT02155985|Secondary|Change in Expression of CD69+ on CD14+CD16+ From Entry to Week 12|Absolute change was calculated as the value at week 12 minus the value at entry.|Entry to Week 12|Analysis used the per-protocol population as in the primary analyses.||percent of CD14+CD16+ expressing CD69+||95% Confidence Interval|Mean
646068|NCT02155985|Secondary|Change in Expression of CD14+CD16+ From Entry to Week 12|Absolute change was calculated as the value at week 12 minus the value at entry.|Entry to Week 12|Analysis used the per-protocol population as in the primary analyses.||percentage of CD14+CD16+||95% Confidence Interval|Mean
646069|NCT02155985|Secondary|Change in Expression of CD69+ on CD14+CD16- From Entry to Week 12|Absolute change was calculated as the value at week 12 minus the value at entry.|Entry to Week 12|Analysis used the per-protocol population as in the primary analyses.||percent of CD14+CD16- expressing CD69+||95% Confidence Interval|Mean
646070|NCT02155985|Secondary|Change in Expression of CD14+CD16- From Entry to Week 12|Absolute change was calculated as the value at week 12 minus the value at entry.|Entry to Week 12|Analysis used the per-protocol population as in the primary analyses.||percentage of CD14+CD16-||95% Confidence Interval|Mean
646071|NCT02155985|Secondary|Change in Expression of CD69+ on CD14dimCD16+ From Entry to Week 12|Absolute change was calculated as the value at week 12 minus the value at entry.|Entry to Week 12|Analysis used the per-protocol population as in the primary analyses.||percent of CD14dimCD16+ expressing CD69+||95% Confidence Interval|Mean
646072|NCT02155985|Secondary|Change in Expression of CD14dimCD16+ From Entry to Week 12|Absolute change was calculated as the value at week 12 minus the value at entry.|Entry to Week 12|Analysis used the per-protocol population as in the primary analyses.||percentage of CD14dimCD16+||95% Confidence Interval|Mean
646311|NCT02149342|Other Pre-specified|Clearance of Field Cancerization in Hyperspectral Images|Data not collected|3 months||||||
646073|NCT02155985|Secondary|Change in sCD163 From Baseline to Week 11/12|"Baseline is defined as the average of the Pre-Entry and Entry values. Week 11/12 is defined as the average of the Week 11 and Week 12 values. All values were log10 transformed prior to calculating change and conducting analyses. Values obtained within 6 days after the influenza vaccination were excluded.
Absolute change was calculated as the value at week 11/12 minus the value at baseline. Mean changes were exponentiated to be back on the untransformed scale and corresponds to a mean fold change."|Pre-entry and entry to weeks 11 and 12|Analysis used the per-protocol population as in the primary analyses.||fold change||95% Confidence Interval|Mean
646074|NCT02155985|Secondary|Tolerability|Tolerability was summarized as the number of participants successfully completing the protocol-defined treatment period.|Treatment dispensation to Week 12|All randomized participants.||Participants|||Count of Participants
646075|NCT02155985|Secondary|Safety|"Safety was summarized as the highest grade sign/symptom, laboratory event, or diagnosis per participant.
Grading (Grade 0: normal, Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life-threatening) was done by site clinicians using DAIDS AE Grading table."|After study entry to Week 16|All randomized participants.||Participants|||Count of Participants
646076|NCT02155985|Primary|Change in sCD14 From Baseline to Week 11/12|"Baseline is defined as the average of the Pre-Entry and Entry values. Week 11/12 is defined as the average of the Week 11 and Week 12 values. All values were log10 transformed prior to calculating change and conducting analyses. Values obtained within 6 days after the influenza vaccination were excluded.
Absolute change was calculated as the value at week 11/12 minus the value at baseline. Mean changes were exponentiated to be back on the untransformed scale and corresponds to a mean fold change. Differences between arms are expressed as the percent difference between mean fold changes."|Pre-entry and entry to weeks 11 and 12|Analysis used the per-protocol population. Participants 1) without baseline AND week 11/12 sCD14 values, or 2) with premature discontinuation of study treatment, or 3) with a serious bacterial infection while on treatment, or 4) with <70% self-reported adherence (based on all available days of recall) to study treatment were excluded.||fold change||95% Confidence Interval|Mean
646077|NCT02155881|Secondary|Change From Baseline Over 2 Weeks in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Individual Domain Score|The RQLQ is a 28-item, disease-specific quality of life questionnaire that measures the functional (physical, emotional, and social) problems troublesome to adults with allergies. The RQLQ has 28 questions in 7 domains (activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms and emotional). All 28 questions were evaluated by the participant in an assessment diary over 2 weeks of treatment period and was rated on a 7-point severity scale ranging from 0 to 6, where 0 = least severe to 6 = extremely severe. Overall domain scores were calculated by taking the mean of the response of the relevant questions. The baseline value was defined as the average score over the Day -6 to Day 0. Change from Baseline was thus calculated as the 2-week average score recorded from Day 1 up to Day 14 minus the Baseline score.|Baseline and Week 1 up to Week 2 (entire treatment period)|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had 1 baseline and at least 1 post-baseline value. Missing data was imputed using LOCF.||scores on a scale||Standard Deviation|Mean
646078|NCT02155881|Secondary|Change From Baseline Over 2 Weeks in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Total Score|The RQLQ is a 28-item, disease-specific quality of life questionnaire that measures the functional (physical, emotional, and social) problems troublesome to adults with allergies. The RQLQ has 28 questions in 7 domains (activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms and emotional). All 28 questions were evaluated by the participant in an assessment diary over 2 weeks of treatment period and was rated on a 7-point severity scale ranging from 0 to 6, where 0 = least severe to 6 = extremely severe. Overall total score was calculated by taking the mean of the response of all individual 28 questions. The baseline value was defined as the average score over the Day -6 to Day 0. Change from Baseline was thus calculated as the 2-week average score recorded from Day 1 up to Day 14 minus the Baseline score.|Baseline and Week 1 up to Week 2 (entire treatment period)|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had 1 baseline and at least 1 post-baseline value. Missing data was imputed using LOCF.||scores on a scale||Standard Deviation|Mean
646079|NCT02155881|Secondary|Change From Baseline Over 2 Weeks in Participant-Reported Individual Morning and Evening Reflective Total Ocular Symptom Score|The reflective TOSS is defined as the sum of the participant-rated reflective symptom scores for 3 ocular symptoms of itching/burning eyes, tearing/watering eyes, and redness of eyes over the past 12 hours. Each symptom was evaluated by the participant in an assessment diary, once in the morning (AM score) and after 12 hours in the evening (PM score) over 2 weeks of treatment period and was rated on a severity scale ranging from 0 to 3, where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe (symptom hard to tolerate, interferes with daily activities/sleeping). Reflective TOSS score ranges from 0-9 with 0 representing an absence of symptoms and 9 representing severe symptoms. The baseline value was defined as the average score over the Day -6 to Day 0. Change from Baseline was thus calculated as the 2-week average score recorded from Day 1 up to Day 14 minus the Baseline score.|Baseline and Week 1 up to Week 2 (entire treatment period)|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had 1 baseline and at least 1 post-baseline value. Missing data was imputed using LOCF.||scores on a scale||Standard Deviation|Mean
646080|NCT02155881|Secondary|Change From Baseline Over 2 Weeks in Participant-Reported Individual Morning and Evening Reflective Total Nasal Symptom Score|The reflective TNSS is defined as the sum of the participant-rated reflective symptom scores for the 4 nasal symptoms of runny nose, itchy nose, sneezing, and nasal congestion over the past 12 hours. Each symptom was evaluated by the participant in an assessment diary, once in the morning (AM score) and after 12 hours in the evening (PM score) over 2 weeks of treatment period and was rated on a severity scale ranging from 0 to 3, where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe (symptom hard to tolerate, interferes with daily activities/sleeping). TNSS score ranges from 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms. The baseline value was defined as the average score over the Day -6 to Day 0. Change from Baseline was thus calculated as the 2-week average score recorded from Day 1 up to Day 14 minus the Baseline score.|Baseline and Week 1 up to Week 2 (entire treatment period)|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had 1 baseline and at least 1 post-baseline value. Missing data was imputed using LOCF.||scores on a scale||Standard Deviation|Mean
646081|NCT02155881|Secondary|Change From Baseline Over 2 Weeks in Participant-Reported Morning and Evening Instantaneous Total Ocular Symptom Scores|The instantaneous TOSS is defined as the sum of the participant-rated instantaneous symptom scores for 3 ocular symptoms of itching/burning eyes, tearing/watering eyes, and redness of eyes at the time of evaluation. Each symptom was evaluated by the participant in an assessment diary, once in the morning (AM score) and after 12 hours in the evening (PM score) over 2 weeks of treatment period and was rated on a severity scale ranging from 0 to 3, where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe (symptom hard to tolerate, interferes with daily activities/sleeping). Instantaneous TOSS score ranges from 0-9 with 0 representing an absence of symptoms and 9 representing severe symptoms. The baseline value was defined as the average score over the Day -6 to Day 0. Change from Baseline was thus calculated as the 2-week average score recorded from Day 1 up to Day 14 minus the Baseline score.|Baseline and Week 1 up to Week 2 (entire treatment period)|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had 1 baseline and at least 1 post-baseline value. Missing data was imputed using LOCF.||scores on a scale||Standard Deviation|Mean
646082|NCT02155881|Secondary|Change From Baseline Over 2 Weeks in Participant-Reported Morning and Evening Reflective Total Ocular Symptom Scores (TOSS)|The reflective TOSS is defined as the sum of the participant-rated reflective symptom scores for 3 ocular symptoms of itching/burning eyes, tearing/watering eyes, and redness of eyes over the past 12 hours. Each symptom was evaluated by the participant in an assessment diary, once in the morning (AM score) and after 12 hours in the evening (PM score) over 2 weeks of treatment period and was rated on a severity scale ranging from 0 to 3, where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe (symptom hard to tolerate, interferes with daily activities/sleeping). Reflective TOSS score ranges from 0-9 with 0 representing an absence of symptoms and 9 representing severe symptoms. The baseline value was defined as the average score over the Day -6 to Day 0. Change from Baseline was thus calculated as the 2-week average score recorded from Day 1 up to Day 14 minus the Baseline score.|Baseline and Week 1 up to Week 2 (entire treatment period)|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had 1 baseline and at least 1 post-baseline value. Missing data was imputed using LOCF.||scores on a scale||Standard Deviation|Mean
646083|NCT02155881|Secondary|Change From Baseline Over 2 Weeks in Participant-Reported Morning and Evening Instantaneous Total Nasal Symptom Scores|The instantaneous TNSS is defined as the sum of the participant-rated instantaneous symptom scores for the 4 nasal symptoms of runny nose, itchy nose, sneezing, and nasal congestion at the time of evaluation. Each symptom was evaluated by the participant in an assessment diary, once in the morning (AM score) and after 12 hours in the evening (PM score) over 2 weeks of treatment period and was rated on a severity scale ranging from 0 to 3, where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe (symptom hard to tolerate, interferes with daily activities/sleeping). TNSS score ranges from 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms. The baseline value was defined as the average score over the Day -6 to Day 0. Change from Baseline was thus calculated as the 2-week average score recorded from Day 1 up to Day 14 minus the Baseline score.|Baseline and Week 1 up to Week 2 (entire treatment period)|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had 1 baseline and at least 1 post-baseline value. Missing data was imputed using LOCF.||scores on a scale||Standard Deviation|Mean
646084|NCT02155881|Primary|Change From Baseline Over 2 Weeks in Participant-Reported Morning and Evening Reflective Total Nasal Symptom Scores (TNSS)|The reflective TNSS is defined as the sum of the participant-rated reflective symptom scores for the 4 nasal symptoms of runny nose, itchy nose, sneezing, and nasal congestion over the past 12 hours. Each symptom was evaluated by the participant in an assessment diary, once in the morning (AM score) and after 12 hours in the evening (PM score) over 2 weeks of treatment period and was rated on a severity scale ranging from 0 to 3, where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe (symptom hard to tolerate, interferes with daily activities/sleeping). TNSS score ranges from 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms. The baseline value was defined as the average score over the Day -6 to Day 0. Change from Baseline was thus calculated as the 2-week average score recorded from Day 1 up to Day 14 minus the Baseline score.|Baseline and Week 1 up to Week 2 (entire treatment period)|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had 1 baseline and at least 1 post-baseline value. Missing data was imputed using Last Observation Carried Forward (LOCF).||scores on a scale||Standard Deviation|Mean
646085|NCT02155543|Primary|Maximal Plasma Concentration (Cmax) of AGN-223575|Concentrations of AGN-223575 were measured in the plasma (the liquid component of the blood in which the blood cells are suspended) in samples collected up to 24 hours post-dose. The Cmax is reported.|Day 15|Pharmacokinetic Population: AGN-223575-treated subjects in cohorts with pharmacokinetic samples (i.e., Cohorts 2 to 5)||Nanograms/Milliliters (ng/mL)||Standard Deviation|Mean
646086|NCT02155335|Primary|Percentage of Participants Who Prefer Prefilled Syringe, Smartject™ Device, or Are Undecided (2 Weeks Post Injections)|Golimumab 50 mg supplied in a prefilled syringe administered 2 times (once by the treating physician and then by the participant under the supervision of the treating physician). Participant than is administered Golimumab 50 mg supplied in the Smartject 2 times, first by the physician and then by the participant. Participants completed a questionnaire 2 weeks after the injections in which they indicated if they preferred the syringe, the Smartject or were undecided as to which they preferred.|Day 14 (2 weeks post injections)|All enrolled participants who met all inclusion and none of the exclusion criteria, received all four injections of golimumab according to the protocol, and completed the device preference questionnaire||Percentage of Participants|||Number
646087|NCT02155335|Primary|Percentage of Participants Who Prefer Prefilled Syringe, Smartject™ Device, or Are Undecided (Day of Injections)|Golimumab 50 mg supplied in a prefilled syringe administered 2 times (once by the treating physician and then by the participant under the supervision of the treating physician). Participant is then administered Golimumab 50 mg supplied in the Smartject 2 times, first by the physician and then by the participant. Following the completion of the last injection, the participants completed a questionnaire in which they indicated if they preferred the syringe, the Smartject or were undecided as to which they preferred.|Day 0 (post last injection)|All enrolled participants who met all inclusion and none of the exclusion criteria, received all four injections of golimumab according to the protocol, and completed the device preference questionnaire||Percentage of Participants|||Number
646089|NCT02155322|Primary|Percentage of Participants Experiencing Adverse Events (AEs)|An adverse event was any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.|From first dose through follow-up; up to 13 months|All participants who received at least one dose of study drug.||Percentage of participants|||Number
646090|NCT02155283|Other Pre-specified|Change in Amount of Pain Determined by the NRS at the 1-week Follow-up After the End of the 3-week Treatment Plan Compared to Baseline (Before Treatment)|Pain level will be scored by the subject using the NRS on a 0 to 10 scale where 10 represents the highest level of pain and 0 represents no pain.|4 weeks|||units on a scale||Standard Deviation|Mean
646091|NCT02155283|Secondary|Change in Heart Rate Variability (and the Autonomic System)|"Gather information regarding:
Autonomic nervous system activity by measuring heart rate variability (HRV)."|3 weeks, 4 weeks||||||
646092|NCT02155283|Secondary|Change in Symmetry of Muscle Function on Either Side of the Spine|"Gather information regarding:
Symmetry of muscle function about the spine using static surface electromyography (SEMG)"|3 weeks, 4 weeks||||||
646093|NCT02155283|Secondary|Change in Functional Health Status by ODI|Functional health status will be determined by the ODI questionnaire completed by the subject (based upon answers from 10 multiple choice questions)|3 weeks, 4 weeks||||||
646094|NCT02155283|Secondary|Change in Proprioception and Vestibular Function.|"Gather information regarding:
Balance and Fall Prevention using digital posturography"|3 weeks, 4 weeks||||||
646095|NCT02155283|Primary|Change in Amount of Pain Determined by the NRS at the End of the 3-week Treatment Plan Compared to Baseline (Before Treatment)|Pain level will be scored by the subject using the NRS on a 0 to 10 scale where 10 represents the highest level of pain and 0 represents no pain.|3 weeks|Completers per protocol||units on a scale||Standard Deviation|Mean
646096|NCT02155010|Secondary|Patient's Anxiety|We compared patient's anxiety using spielberger's state-trait anxiety inventory before and after surgery. This consists of two self-evaluation scales designed to assess state-anxiety and trait-anxiety. Each scale contains 20 items, each of which is rated from 1 to 4. Clinically significant levels of state or trait-anxiety were defined as scores >50 on the state- or trait-anxiety scale. State or trait-anxiety inventory's minimal score is 20 and maximal score is 80. We analyzed State Anxiety Inventory scale before and after surgery.|up to 3 days|||points||Standard Deviation|Mean
646097|NCT02155010|Primary|Incidence of Hypotension|We compare incidence rate of hypotension during infusion of dexmedetomidine|up to 3 hours|||participants|||Number
646098|NCT02154906|Secondary|Change in Radiographic Bone Level|measurement of radiographic bone level at the time of surgical intervention will be compared with measurement of bone level 6 months after surgery|baseline and 6 months after surgery|||mm||Standard Deviation|Mean
646099|NCT02154906|Primary|Change in Clinical Attachment Level (CAL)|measurement of CAL at the time of surgical intervention will be compared with measurement of CAL and bone level 6 months after surgery|baseline and 6 months after surgery|||mm||Standard Deviation|Mean
646100|NCT02154425|Primary|The Average Daily Infant Dose of Certolizumab Pegol (CZP) Over the Dosing Interval (14 or 28 Days)|Mature breast milk samples will be collected (pre-dose, as applicable for subjects receiving CZP 200 mg Q2W) on Day 14 or on Day 28 of the Sampling Period for all subjects.|From Day 0 to Day 14 or 28|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.||mg/kg/day||Full Range|Median
646101|NCT02154425|Primary|The Calculated Infant Daily Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 28|In subjects receiving CZP 400 mg Q4W, a mature breast milk sample was collected on or about Day 28, prior to the next scheduled administration of CZP.|Day 28|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable. Measurement on day 28 applies to subjects on a CZP 400mg Q4W dosing regimen only.||mg/kg/day||Full Range|Median
646102|NCT02154425|Primary|The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast on Day 14|Mature breast milk samples was collected (pre-dose, as applicable for subjects receiving CZP 200 mg Q2W) on Day 14 of the Sampling Period for all subjects.|Day 14|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.||mg/kg/day||Full Range|Median
646103|NCT02154425|Primary|The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 12|Mature breast milk samples was collected on Day 12 of the Sampling Period for all subjects.|Day 12|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.||mg/kg/day||Full Range|Median
646104|NCT02154425|Primary|The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 10|Mature breast milk samples was collected on Day 10 of the Sampling Period for all subjects.|Day 10|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.||mg/kg/day||Full Range|Median
646105|NCT02154425|Primary|The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 8|Mature breast milk samples was collected on Day 8 of the Sampling Period for all subjects.|Day 8|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.||mg/kg/day||Full Range|Median
646106|NCT02154425|Primary|The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 6|Mature breast milk samples was collected on Day 6 of the Sampling Period for all subjects.|Day 6|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.||mg/kg/day||Full Range|Median
646107|NCT02154425|Primary|The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 4|Mature breast milk samples was collected on Day 4 of the Sampling Period for all subjects.|Day 4|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.||mg/kg/day||Full Range|Median
650039|NCT02062801|Secondary|Urgent Cesarean Delivery|Incidence of urgent cesarean delivery|Within 30 minutes of combined spinal epidural (CSE) placement|||participants|||Number
646108|NCT02154425|Primary|The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 2|Mature breast milk samples was collected on Day 2 of the Sampling Period for all subjects.|Day 2|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.||mg/kg/day||Full Range|Median
646109|NCT02154425|Primary|The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 28|In subjects receiving CZP 400 mg Q4W, a mature breast milk sample were collected on or about Day 28, prior to the next scheduled administration of CZP.|Day 28|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.||µg/mL||Full Range|Median
646110|NCT02154425|Primary|The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 14|Mature breast milk samples were collected (predose, as applicable for subjects receiving CZP 200 mg Q2W) on Day 14 of the Sampling Period for all subjects.|Day 14|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.||µg/mL||Full Range|Mean
646111|NCT02154425|Primary|The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 12|Mature breast milk samples were collected on Day 12 of the Sampling Period for all subjects.|Day 12|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.||µg/mL||Full Range|Median
646112|NCT02154425|Primary|The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 10|Mature breast milk samples were collected on Day 10 of the Sampling Period for all subjects.|Day 10|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.||µg/mL||Full Range|Median
646113|NCT02154425|Primary|The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 8|Mature breast milk samples were collected on Day 8 of the Sampling Period for all subjects.|Day 8|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.||µg/mL||Full Range|Median
646114|NCT02154425|Primary|The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 6|Mature breast milk samples were collected on Day 6 of the Sampling Period for all subjects.|Day 6|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.||µg/mL||Full Range|Median
646115|NCT02154425|Primary|The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 4|Mature breast milk samples were collected on Day 4 of the Sampling Period for all subjects.|Day 4|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.||µg/mL||Full Range|Median
646116|NCT02154425|Primary|The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 2|Mature breast milk samples were collected on Day 2 of the Sampling Period for all subjects.|Day 2|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.||µg/mL||Full Range|Median
646117|NCT02154425|Primary|The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 0|Mature breast milk samples were collected predose on Day 0 of the Sampling Period (CZP dosing day) for all subjects.|Day 0|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.||µg/mL||Full Range|Median
646118|NCT02154386|Secondary|Change in Buccal Ridge Height|Ridge height measured at time of tooth extraction and grafting and again at time of implant placement. Changes in ridge height are determined (negative number signifies loss of ridge height)|at time of implant placement at 8-10 or 18-20 weeks following tooth extraction and grafting|||change in bone height (mm)||Standard Deviation|Mean
646119|NCT02154386|Secondary|Change in Ridge Width|Ridge width measured at time of tooth extraction and grafting and again at time of implant placement. Changes in ridge width are determined (negative number signifies loss of ridge width)|at time of implant placement at 8-10 or 18-20 weeks following tooth extraction and grafting|||ridge width change (mm)||Standard Deviation|Mean
646120|NCT02154386|Primary|Percent New Vital Bone Formation|Bone core biopsy will be evaluated histologically for percent new vital bone formation|after removal of bone core from site of dental implant placement at 18-20 weeks following tooth extraction and grafting|||percentage of vital bone||Standard Deviation|Mean
646121|NCT02154243|Secondary|Length of Stay||Length of the hospital stay (average of 4 days)|DATA WAS NOT COLLECTED. STUDY TERMINATED EARLY.|||||
646122|NCT02154243|Primary|Change in Orthostatic Hypotension Questionnaire Score||From baseline assessment to post-intervention (30 min, 1 hr, 2 hrs, 3 hrs, 4 hrs)|DATA WAS NOT COLLECTED. STUDY TERMINATED EARLY.|||||
646123|NCT02154139|Secondary|Percentage of Participants With Recurrence-free Survival Who Were Treated With the Drug as Adjuvant Therapy|Recurrence-free survival was determined in participants who were treated with the drug as adjuvant therapy, and tabulated, based on the date recurrence is confirmed, the presence or absence of recurrence, continued survival or death, and the date of death.|Baseline up to 96 weeks|The efficacy assessment population was defined as participants with advanced or recurrent breast cancer whose efficacy data at baseline and at least 1 post-baseline time points was available.||percentage of participants||95% Confidence Interval|Number
646137|NCT02153788|Secondary|Mean Change in the Hospital Anxiety and Depression Scale - Anxiety (HADS-A)|A scale designed to detect states of anxiety and depression in the setting of an outpatient clinic, that consists of 2 sets: the HADS-A (Anxiety) and HADS-D (Depression). This is a series of 7 questions in each set (for a total of 14), assessed on a scale from 0-4, 0 being the response that indicates the least anxiety or depression, and 4 the most. Separate scores are calculated for anxiety and depression and a score (ranging from 0 to 21) is obtained for each subscale. The higher the score, the more severe the anxiety or depression.|Baseline, week 12|||units on a scale||Standard Deviation|Mean
647355|NCT02127567|Secondary|The Score for Completeness of Reporting for Randomization|The score for completeness of reporting (0-10) for the manuscript section randomization, 0 being the lowest and 10 the highest|one time measure after a four-hour writing session|||units on a scale|Participants|Standard Deviation|Mean
646124|NCT02154139|Secondary|Percentage of Participants With Progression Free Survival|Progression-free survival (PFS) was defined as the time from the first day of study treatment to documented disease progression or death on study (ie, death from any cause within 30 days of the last dose of study drug), whichever occurred first. Disease progression was at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. For patients who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate PFS.|Baseline up to 96 weeks|The efficacy assessment population was defined as participants with advanced or recurrent breast cancer whose efficacy data at baseline and at least 1 post-baseline time points was available.||percentage of participants||95% Confidence Interval|Number
646125|NCT02154139|Secondary|Percentage of Participants With Advanced or Recurrent Breast Cancer (Best Response)|Best overall response for a participant is the best observed post-baseline disease response as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 criteria. Objective response was defined as a complete response (CR) or partial response (PR) determined on 2 consecutive occasions greater than or equal to (>=) 4 weeks apart, using Response Evaluation Criteria in Solid Tumors (RECIST). CR: The disappearance of all target lesions and all non-target lesions, normalization of tumor marker level, and no new lesions. PR: Disappearance of all target lesions and persistence of >= 1 non-target lesions and/or the maintenance of tumor marker level above the normal limits, or, at least a 30 percent (%) decrease in the sum of the longest diameter of target lesions, and no new lesions or unequivocal progression of existing non-target lesions.|Week 24, 48,96|The efficacy assessment population was defined as participants with advanced or recurrent breast cancer whose efficacy data at baseline and at least 1 post-baseline time points was available.||percentage of participants||95% Confidence Interval|Number
646126|NCT02154139|Primary|Number of Participants Reporting One or More Serious Adverse Drug Reactions|Serious adverse drug reactions are defined as serious adverse events (SAE) which are in the investigator’s opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The event occurred was breast cancer female|Baseline up to 96 weeks|Safety analysis set was defined as participants who were enrolled and completed the study.||participants|||Number
646127|NCT02154139|Primary|Number of Participants Reporting One or More Adverse Drug Reactions|Adverse drug reactions are defined as adverse events (AE) which are in the investigator’s opinion of causal relationship to the study treatment. AE are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.|Baseline up to 96 weeks|Safety analysis set was defined as participants who were enrolled and completed the study.||participants|||Number
646128|NCT02154087|Primary|Determine Change From Baseline in Cell Numbers in Subjects With VLU Following the First Dose of HP802-247|The following mediators were to be measured for the chronic ulcer stage: IL-1β, IL-6, TNF-α, IFN, MMP-2, and MMP-9, and the following for the resolving ulcer stage: PGE-2, Lipoxin, GM-CSF, TGFβ, IL-10, LL-37, Indoleamine 2,3-Dioxygenase (IDO), and Arginase (ARG-1). Each of the soluble mediators were to be plotted versus measurement time point [i.e., (pre-study run-in visit (RV)1), baseline (RV3), study visit (SV)2, and SV3]) and by subjects’ quartile of percent reduction (%) in target wound area at SV3 from baseline (RV3).|Wound fluid samples were to be collected one week after the initial dose of HP802-247.|Due to the failure of HP802-247-09-029 to show superiority over its vehicle in study 802-247-09-029, this study was terminated after enrollment of one of the proposed 25 subjects. No data was collected.|||||
646129|NCT02154048|Primary|Time to First Analgesic Dose||48 hours|one subject in the Local Anesthetic (LA) Control Group was not analyzed because subject did not return the data sheet||hours||Standard Deviation|Mean
646130|NCT02153827|Secondary|Upper Quarter Y Balance Test|Measure of single arm reach with 0 being the least and higher numbers indicating greater distance reached.|6 months|||cm of reach divided by limb length||Standard Deviation|Mean
646131|NCT02153827|Secondary|Shoulder Active Range of Motion|Degrees of shoulder elevation with 0 being the least and 180 being the greatest.|6 months|||Degrees||Standard Deviation|Mean
646132|NCT02153827|Secondary|Numeric Pain Rating Scale|0-10 pain scale with 0 meaning no pain and 10 being maximal pain. This is derived from a single item questionnaire.|6 months|||units on a scale 0-10||Standard Deviation|Mean
646133|NCT02153827|Secondary|Global Rating of Change|Global rating of change is a single item questionnaire asking about total change since beginning treatment. The scale ranges from -7 (a great deal worse) to +7 (a great deal better). The unit of measure is scores on a scale.|6 months|||units on a scale||Standard Deviation|Mean
646134|NCT02153827|Primary|Change in Western Ontario Rotator Cuff Index|shoulder functional self report measure is a disease specific self reported outcome measure for individuals experiencing rotator cuff pathology. A score of 0 is the minimum score and indicates low levels of shoulder function. A score of 100 is the maximum score and indicates full shoulder function. Scores are derived by summing all 5 subscales and dividing that number by the total available number of 2100. Units for each item are derived from a visual analog scale totaling 100cm.|6 months|||units on a scale derived from 100cm vas||Standard Deviation|Mean
646135|NCT02153788|Secondary|Mean Change in the Hospital Anxiety and Depression Scale - Depression (HADS-D)|A scale designed to detect states of anxiety and depression in the setting of an outpatient clinic, that consists of 2 sets: the HADS-A (Anxiety) and HADS-D (Depression). This is a series of 7 questions in each set (for a total of 14), assessed on a scale from 0-4, 0 being the response that indicates the least anxiety or depression, and 4 the most. Separate scores are calculated for anxiety and depression and a score (ranging from 0 to 21) is obtained for each subscale. The higher the score, the more severe the anxiety or depression.|Baseline, week 12|||units on a scale||Standard Deviation|Mean
646136|NCT02153788|Secondary|Mean Change in the Distress Thermometer|A clinical tool that has been validated widely especially in cancer patients, to detect clinically significant emotional distress. This is a one-item scale that asks participants to rate their distress on scale from 0-100. Lower scores represent less distress and higher scores indicate greater distress.|Baseline, week 12|||units on a scale||Standard Deviation|Mean
646138|NCT02153788|Secondary|Mean Change in Piper Fatigue Score|A multidimensional scale for measuring fatigue, whose validity and reliability have been established across many patient populations including cancer patients, HIV, pregnancy, and myocardial infarction. There are 22 questions, in 3 subscales that measure behavioral, affective meaning, sensory and cognitive/mood aspects of fatigue, each scored on an 11-point likhert scale with a score of 0-10, 0 indicating no fatigue and 10 indicating the most severe fatigue. The Piper Fatigue Scale can range from 0 to 220 with higher scores indicating greater fatigue.|Baseline, week 12|||units on a scale||Standard Deviation|Mean
646139|NCT02153788|Secondary|Mean Change in Self-reported Total Sleep Time|Mean change in self-reported total sleep time from randomization to the end of the open label phase|Randomization to the end of the open label phase, approximately 1 week|Data not collected, and therefore not analyzed.|||||
646140|NCT02153788|Secondary|Mean Change in Self Reported Total Sleep Time|Mean change in self reported Total Sleep Time from Randomization to Final Study Visit in the placebo-controlled phase.|Randomization to final study visit, approximately 12 weeks|Data not collected, and therefore not analyzed.|||||
646141|NCT02153788|Primary|Mean Change in the Insomnia Severity Index|Mean change in the total score of the Insomnia Severity Index from Randomization to Final Study Visit after 12 weeks of double blind, placebo controlled dosing. The Insomnia Severity Index (ISI), is a 7-item questionnaire on a Likhert scale (0-4) assessing sleep initiation, sleep maintenance, satisfaction/distress over sleep problems, and daytime dysfunction. Responses to each item are summed to obtain a total score to determine the severity of insomnia. The total score can range from 0 to 28 with higher scores indicating greater insomnia severity.|Randomization to final study visit, approximately 12 weeks|||units on a scale||Standard Deviation|Mean
646142|NCT02153736|Secondary|Test of Infant Motor Performance (TIMP)|The TIMP is a standardized and norm references test of motor control and posture in infants 4 months of age and younger which is commonly used with infants starting at 34 weeks of post-menstrual age. Change in raw score from baseline to end of the intervention is reported. The TIMP raw score ranges from 0 to 142. A higher score represented greater performance in motor control and posture.|Baseline to End of intervention|Full Sample after infants lost to follow up who are not included in this analysis.||Raw Score on the TIMP||Inter-Quartile Range|Median
646143|NCT02153736|Secondary|Bayley Scales of Infant and Toddler Development (Bayley).|The Bayley-III is a norm references standardized developmental assessment of Motor, Cognitive, and Language skills. Composite scores for each domain have a mean of 100 and a standard deviation of 15. A score of 85-115 is considered average. Higher composite scores represent higher or better performance on that subtest. The Bayley was administered at the final follow-up visit and 3 months after the intervention ended.|3 month post intervention|At 3 months post intervention the sample was consistent with that described in the study sample post lose to followup.||Mean Composite Score on Bayley||Standard Deviation|Mean
646144|NCT02153736|Secondary|Parent Child Early Relational Assessment (PCERA)|The Parent-Child Early Relational Assessment (PCERA; Clark, 2010; Clark, 1999) was designed to assess mother-infant interaction. In this study PCERA was scored from a video of the feeding interaction. The PCERA is a 65-item observational rating scale (29 parental, 27 infant, and 8 dyadic), designed to assess the amount, duration, and intensity of interaction. Each item was rated on a 3-point ordinal scale with 1-2 indicating an area of concern, 3 indicating an area for some concern and 4- 5 indicating an area of strength. Eight subscales constructed from items of the PCERA have been theoretically derived and confirmed by factor analysis (Clark, 1999; Clark et al., 1997). For ease of analysis this scale was transformed to a -1 to +1 range. Scores were recorded as 1 or 2 = -1, 3= 0, 4 or 5 = 1. The total PCERA score is the mean of all the subscale mean scores and ranged -1 (highest risk of atypical interactions) to +1 (most positive interactions).|Baseline, End phase 1, End of intervention, 1 month post intervention|The sample varied some between visits do to a lack of video taping the parent child interaction on a few occasions because the parent who consented to the study was not present at the time of the visit and the visit could not be rescheduled. The 3 month post intervention visit was dropped.||Mean Score on PCERA||Standard Deviation|Mean
646145|NCT02153736|Secondary|Early Feeding Skill Assessment (FES)|The Early Feeding Skills (EFS) was used to assess the infant’s oral feeding skills during the video recorded feeding described above. The EFS is a 26-item observational tool that can be used from the start of oral feeding through the maturation of feeding skills. Each item can score 1-3 with one representing the least skill or high frequency of problem (an area of clinical concern), and three representing mature skill or absence of problem (area of strength). Subscales included were ability to maintain engagement in feeding, ability to organize oral-motor functioning, ability to coordinate swallowing, and ability to maintain physiological stability. The sum of all the items in a subscale divided by the number of items in the subscale gives the subscale score of 1-3. The sum of all subscales was used to create an EFS total score which could range from 2 to 12 with a higher score reflecting a better feeding performance.|Baseline, End phase 1, End of intervention, 1 and 3 months post intervention|Some infants were not able to orally feed in which case this measure was not included. In addition, some visits were missing feeding assessments for missing data. Thus the sample included varied some between visits.||EFS Total score||Standard Deviation|Mean
646146|NCT02153736|Primary|Early Problem Solving Indicator (EPSI)|Problem-solving behaviors were assessed using the Early Problem Solving Indicator (EPSI). The EPSI is the cognitive subtest of the Individual Growth and Development Indicators designed to measure infant and toddler play-based problem-solving through 36 months of age. It defines problem-solving as consisting of visual exploration, object manipulation and memory. The infant was video-recorded interacting with 3 standard toys: pop-up animals toy, 6 seriated, plastic cups, and a gum ball machine with 5 balls. Infants were given each toy for 2 minutes. The frequency of 4 mutually exclusive behaviors (look, explore, function, solution) were coded using definitions from the EPSI protocol. time. The total number of problem solving behaviors was calculated as a sum of look, explore, function, and solution for each infant at each visit and reported as the total EPSI frequency with a higher frequency reflecting more problem solving behaviors.|End of intervention, 1 and 3 months post intervention|Same as primary population with the 2 infants lost to follow up not included.||# of Problem Solving Behaviors in 6 min||Standard Deviation|Mean
646147|NCT02153736|Primary|Reaching (Toy Contact Duration)|Duration the infant is in contact with the target is used to quantify changes in reaching.|1 month post intervention|||Seconds||Standard Deviation|Mean
646148|NCT02153489|Other Pre-specified|Change From Baseline in Number of Steps Per Day||Week 3 of treatment|||Number of steps per day||Standard Error|Least Squares Mean
646153|NCT02153489|Other Pre-specified|Change From Baseline in Oxygen Desaturation Index (ODI) Per Hour of Total Sleep Time|The oxygen desaturation index (ODI) is the number of times per hour of sleep that the blood's oxygen level drop by a certain degree from baseline. In this study, any event with a 4% decrease in blood oxygen levels counted towards the total|Week 3 of treatment|||Events/hr||Standard Error|Least Squares Mean
646154|NCT02153489|Other Pre-specified|Change From Baseline in Apnea-hypopnea Index (AHI) Per Hour of Total Sleep Time|The Apnea Hypopnea Index (AHI) is used to indicate the severity of obstructive sleep apnea. The AHI is the number of apneas or hypopneas recorded during the study per hour of sleep|Week 3 of treatment|||Events/hr||Standard Error|Least Squares Mean
646155|NCT02153489|Other Pre-specified|Change From Baseline in the Average Rating of COPD Symptoms Limiting Evening Activities|The evening symptoms questionnaire was filled out after the second medication administration of the day and before bedtime. Scores ranged from 0 (no symptoms) to 4 (very severe symptoms). Symptoms assessed over 24 weeks included change from baseline in the severity of evening cough, wheezing, shortness of breath and tightness of the chest, chest congestion, difficulty bringing up phlegm, overall evening symptom severity, and limitation of evening activities due to COPD symptoms|Week 3 of treatment|||Score on a scale||Standard Deviation|Mean
646156|NCT02153489|Other Pre-specified|Change From Baseline in the Average Rating of COPD Symptoms Limiting Early Morning Activities|Night-time and early-morning symptoms were recorded every morning using the Early-Morning Symptoms of COPD Instrument [EMSCI] and the Night-time Symptoms of COPD Instrument [NiSCI]. Scores ranged from 0 (no symptoms) to 4 (very severe symptoms). The questionnaires also evaluated nocturnal awakenings and limitation of early-morning activities (scores ranged from 0 [no limitation] to 4 [a very great deal]). Symptoms assessed over 24 weeks included change from baseline in the severity of night-time and early-morning cough, wheezing, shortness of breath and difficulty bringing up phlegm, overall night-time and early-morning symptom severity, number of nocturnal awakenings and limitation of early-morning activities due to COPD symptoms|Week 3 of treatment|||Score on a scale||Standard Deviation|Mean
646157|NCT02153489|Other Pre-specified|Change From Baseline in the Average Rating of Overall Night-time COPD Symptom Severity|Night-time and early-morning symptoms were recorded every morning using the Early-Morning Symptoms of COPD Instrument [EMSCI] and the Night-time Symptoms of COPD Instrument [NiSCI]. Scores ranged from 0 (no symptoms) to 4 (very severe symptoms). The questionnaires also evaluated nocturnal awakenings and limitation of early-morning activities (scores ranged from 0 [no limitation] to 4 [a very great deal]). Symptoms assessed over 24 weeks included change from baseline in the severity of night-time and early-morning cough, wheezing, shortness of breath and difficulty bringing up phlegm, overall night-time and early-morning symptom severity, number of nocturnal awakenings and limitation of early-morning activities due to COPD symptoms|Week 3 of treatment|||Score on a scale||Standard Deviation|Mean
646158|NCT02153489|Other Pre-specified|Change From Baseline in the Average Rating of Overall Evening COPD Symptom Severity|The evening symptoms questionnaire was filled out after the second medication administration of the day and before bedtime. Scores ranged from 0 (no symptoms) to 4 (very severe symptoms). Symptoms assessed over 24 weeks included change from baseline in the severity of evening cough, wheezing, shortness of breath and tightness of the chest, chest congestion, difficulty bringing up phlegm, overall evening symptom severity, and limitation of evening activities due to COPD symptoms|Week 3 of treatment|||Score on a scale||Standard Deviation|Mean
646159|NCT02153489|Other Pre-specified|Change From Baseline in the Average Rating of Overall Early Morning COPD Symptom Severity|Night-time and early-morning symptoms were recorded every morning using the Early-Morning Symptoms of COPD Instrument [EMSCI] and the Night-time Symptoms of COPD Instrument [NiSCI]. Scores ranged from 0 (no symptoms) to 4 (very severe symptoms). The questionnaires also evaluated nocturnal awakenings and limitation of early-morning activities (scores ranged from 0 [no limitation] to 4 [a very great deal]). Symptoms assessed over 24 weeks included change from baseline in the severity of night-time and early-morning cough, wheezing, shortness of breath and difficulty bringing up phlegm, overall night-time and early-morning symptom severity, number of nocturnal awakenings and limitation of early-morning activities due to COPD symptoms|Week 3 of treatment|||Score on a scale||Standard Deviation|Mean
646160|NCT02153489|Other Pre-specified|Change From Baseline in Normalized FEV1 AUC12-24hr||12, 12.5, 13, 14, 15, 16, 19, 22, 23, and 24 hours at Week 3 of treatment|||L/sec*hr||Standard Error|Least Squares Mean
646161|NCT02153489|Other Pre-specified|Change From Baseline in Normalized FEV1 AUC0-12hr||0, 0.5, 1, 2, 3, 4, 6, 8, 10, 11 and 12 hours at Week 3 of treatment|||L/sec*hr||Standard Error|Least Squares Mean
646162|NCT02153489|Other Pre-specified|Change From Baseline in Peak FEV1||Week 3 of treatment|||Liters/sec||Standard Error|Least Squares Mean
646163|NCT02153489|Other Pre-specified|Change From Baseline in Morning Trough FEV1||Week 3 of treatment|||Liters/sec||Standard Error|Least Squares Mean
646164|NCT02153489|Primary|Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) AUC0-24hr||0, 0.5, 1, 2, 3, 4, 6, 8, 10, 11, 12, 12.5, 13, 14, 15, 16, 19, 22, 23, and 24 hours at Week 3 of treatment|||L/sec*hr||Standard Error|Least Squares Mean
646165|NCT02153398|Secondary|Apparent Volume of Distribution (Vz/F) of Esomeprazole After at Least 5 Days of Repeated Dose||0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose|All patients who had at least one plasma concentration data after administration of study drug without any protocol deviations that would have an impact on the PK.||L||Standard Deviation|Mean
646166|NCT02153398|Secondary|Apparent Total Clearance (CL/F) of Esomeprazole After at Least 5 Days of Repeated Dose||0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose|All patients who had at least one plasma concentration data after administration of study drug without any protocol deviations that would have an impact on the PK.||L/h||Standard Deviation|Mean
646167|NCT02153398|Secondary|Elimination Half-life (t1/2) of Esomeprazole After at Least 5 Days of Repeated Dose||0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose|All patients who had at least one plasma concentration data after administration of study drug without any protocol deviations that would have an impact on the PK.||hour||Standard Deviation|Mean
646168|NCT02153398|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Esomeprazole After at Least 5 Days of Repeated Dose||0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose|All patients who had at least one plasma concentration data after administration of study drug without any protocol deviations that would have an impact on the PK.||hour||Full Range|Median
646169|NCT02153398|Secondary|Maximum Plasma Concentration (Cmax) of Esomeprazole After at Least 5 Days of Repeated Dose||0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose|All patients who had at least one plasma concentration data after administration of study drug without any protocol deviations that would have an impact on the PK.||μmol/L||Standard Deviation|Mean
646170|NCT02153398|Secondary|AUC From Time Zero to Time of Last Quantifiable Concentration (AUC0-t) of Esomeprazole After at Least 5 Days of Repeated Dose||0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose|All patients who had at least one plasma concentration data after administration of study drug without any protocol deviations that would have an impact on the PK.||μmol*h/L||Standard Deviation|Mean
646171|NCT02153398|Secondary|Area Under the Plasma Concentration-time Curve During a Dosing Interval (AUCtau) of Esomeprazole After at Least 5 Days of Repeated Dose||0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose|All patients who had at least one plasma concentration data after administration of study drug without any protocol deviations that would have an impact on the pharmacokinetics (PK).||μmol*h/L||Standard Deviation|Mean
646172|NCT02153398|Primary|Aggravation of Regurgitation at Week 8 by Investigators|The investigators assessed the presence/absence and the intensity of regurgitation at baseline and Week 8 based on questioning the patients or patients’ guardians and the patient diary. Patients who recognized aggravation of regurgitation were defined as those who had no regurgitation at pre-dose and did have any of the corresponding symptoms at Week 8 judged by investigators.|8 weeks|Participants who had no regurgitation at pre-dose and were evaluated the symptom at Week 8 by investigators.||Participants|||Number
646173|NCT02153398|Primary|Aggravation of Upper Abdominal Discomfort at Week 8 by Investigators|The investigators assessed the presence/absence and the intensity of upper abdominal discomfort at baseline and Week 8 based on questioning the patients or patients’ guardians and the patient diary. Patients who recognized aggravation of upper abdominal discomfort were defined as those who had no upper abdominal discomfort at pre-dose and did have any of the corresponding symptoms at Week 8 judged by investigators.|8 weeks|Participants who had no upper abdominal discomfort at pre-dose and were evaluated the symptom at Week 8 by investigators.||Participants|||Number
646174|NCT02153398|Primary|Aggravation of Epigastric Pain at Week 8 by Investigators|The investigators assessed the presence/absence and the intensity of epigastric pain at baseline and Week 8 based on questioning the patients or patients’ guardians and the patient diary. Patients who recognized aggravation of epigastric pain were defined as those who had no epigastric pain at pre-dose and did have any of the corresponding symptoms at Week 8 judged by investigators.|8 weeks|Participants who had no epigastric pain at pre-dose and were evaluated the symptom at Week 8 by investigators.||Participants|||Number
646175|NCT02153398|Primary|Aggravation of Heartburn at Week 8 by Investigators|The investigators assessed the presence/absence and the intensity of heartburn at baseline and Week 8 based on questioning the patients or patients’ guardians and the patient diary. Patients who recognized aggravation of heartburn were defined as those who had no heartburn at pre-dose and did have any of the corresponding symptoms at Week 8 judged by investigators.|8 weeks|Participants who had no heartburn at pre-dose and were evaluated the symptom at Week 8 by investigators.||Participants|||Number
646176|NCT02153398|Primary|Disappearance of Regurgitation at Week 8 by Investigators|The investigators assessed the presence/absence and the intensity of regurgitation at baseline and Week 8 based on questioning the patients or patients’ guardians and the patient diary. Patients who recognized disappearance of regurgitation were defined as those who had a regurgitation at pre-dose and did not have the corresponding symptoms at Week 8 judged by investigators.|8 weeks|Participants who had a regurgitation at pre-dose and were evaluated the symptom at Week 8 by investigators.||Participants|||Number
646177|NCT02153398|Primary|Disappearance of Upper Abdominal Discomfort at Week 8 by Investigators|The investigators assessed the presence/absence and the intensity of upper abdominal discomfort at baseline and Week 8 based on questioning the patients or patients’ guardians and the patient diary. Patients who recognized disappearance of upper abdominal discomfort were defined as those who had an upper abdominal discomfort at pre-dose and did not have the corresponding symptoms at Week 8 judged by investigators.|8 weeks|Participants who had an upper abdominal discomfort at pre-dose and were evaluated the symptom at Week 8 by investigators.||Participants|||Number
646178|NCT02153398|Primary|Disappearance of Epigastric Pain at Week 8 by Investigators|The investigators assessed the presence/absence and the intensity of epigastric pain at baseline and Week 8 based on questioning the patients or patients’ guardians and the patient diary. Patients who recognized disappearance of epigastric pain were defined as those who had an epigastric pain at pre-dose and did not have the corresponding symptoms at Week 8 judged by investigators.|8 weeks|Participants who had an epigastric pain at pre-dose and were evaluated the symptom at Week 8 by investigators.||Participants|||Number
646179|NCT02153398|Primary|Disappearance of Heartburn at Week 8 by Investigators|The investigators assessed the presence/absence and the intensity of heartburn at baseline and Week 8 based on questioning the patients or patients’ guardians and the patient diary. Patients who recognized disappearance of heartburn were defined as those who had a heartburn at pre-dose and did not have the corresponding symptoms at Week 8 judged by investigators.|8 weeks|Participants who had a heartburn at pre-dose and were evaluated the symptom at Week 8 by investigators.||Participants|||Number
646180|NCT02153398|Primary|Aggravation of Regurgitation at Week 8 by Patient Diaries|"The aggravation of regurgitation was assessed by the intensity of the symptom at Week 8. Patients who recognized aggravation of regurgitation were defined as those who selected None to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of Mild, Moderate or Severe at Week 8."|8 weeks|Participants who had no regurgitation at pre-dose in patient diary and obtained available diary data at Week 8.||participants|||Number
646181|NCT02153398|Primary|Aggravation of Upper Abdominal Discomfort at Week 8 by Patient Diaries|"The aggravation of upper abdominal discomfort was assessed by the intensity of the symptom at Week 8. Patients who recognized aggravation of upper abdominal discomfort were defined as those who selected None to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of Mild, Moderate or Severe at Week 8."|8 weeks|Participants who had no upper abdominal discomfort at pre-dose in patient diary and obtained available diary data at Week 8.||participants|||Number
649051|NCT02092441|Secondary|Verbal Numerical Rating Scale Pain Score (0-10) at 10 Minutes Post Intervention|"Scale ranges from 0 (no pain) to 10 (worst pain imaginable)"|10 minutes post intervention|||VNRS||Inter-Quartile Range|Median
646182|NCT02153398|Primary|Aggravation of Epigastric Pain at Week 8 by Patient Diaries|"The aggravation of epigastric pain was assessed by the intensity of the symptom at Week 8. Patients who recognized aggravation of epigastric pain were defined as those who selected None to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of Mild, Moderate or Severe at Week 8."|8 weeks|Participants who had no epigastric pain at pre-dose in patient diary and obtained available diary data at Week 8.||participants|||Number
646183|NCT02153398|Primary|Aggravation of Heartburn at Week 8 by Patient Diaries|"The aggravation of heartburn was assessed by the intensity of the symptom at Week 8. Patients who recognized aggravation of heartburn were defined as those who selected None to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of Mild, Moderate or Severe at Week 8."|8 weeks|Participants who had no heartburn at pre-dose in patient diary and obtained available diary data at Week 8.||participants|||Number
646184|NCT02153398|Primary|Disappearance of Regurgitation at Week 8 by Patient Diaries|"The disappearance of regurgitation was assessed by the intensity of the symptom at Week 8. Patients who recognized disappearance of regurgitation were defined as those who selected Mild, Moderate, or Severe to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of None at Week 8."|8 weeks|Participants who had regurgitation at pre-dose in patient diary and obtained available diary data at Week 8.||Participants|||Number
646185|NCT02153398|Primary|Disappearance of Upper Abdominal Discomfort at Week 8 by Patient Diaries|"The disappearance of upper abdominal discomfort was assessed by the intensity of the symptom at Week 8. Patients who recognized disappearance of upper abdominal discomfort were defined as those who selected Mild, Moderate, or Severe to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of None at Week 8."|8 weeks|Participants who had upper abdominal discomfort at pre-dose in patient diary and obtained available diary data at Week 8.||Participants|||Number
646186|NCT02153398|Primary|Disappearance of Epigastric Pain at Week 8 by Patient Diaries|"The disappearance of epigastric pain was assessed by the intensity of the symptom at Week 8. Patients who recognized disappearance of epigastric pain were defined as those who selected Mild, Moderate, or Severe to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of None at Week 8."|8 weeks|Participants who had epigastric pain at pre-dose in patient diary and obtained available diary data at Week 8.||Participants|||Number
646187|NCT02153398|Primary|Disappearance of Heartburn at Week 8 by Patient Diaries|"The disappearance of heartburn was assessed by the intensity of the symptom at Week 8. Patients who recognized disappearance of heartburn were defined as those who selected Mild, Moderate, or Severe to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of None at Week 8."|8 weeks|Participants who had heartburn at pre-dose in patient diary and obtained available diary data at Week 8.||Participants|||Number
646188|NCT02153346|Secondary|Work Productivity Loss as Assessed in Hours Using Work Productivity and Activity Impairment (WPAI) During the Specified Time Points|WPAI is a self-administered instrument to determine the degree to which asthma affected work productivity while at work and affected activities outside of work in the last 7 days and yields 4 types of scores: Absenteeism (work time missed/missed due to other reasons); Presenteeism (actual time worked); Work Productivity Loss (affected productivity while working); and Activity Impairment (affected regular activities). The following parameters were presented: Hours (Hrs) missed due to asthma (HMA), Hrs missed due to other reasons (HMO), and Hrs actually worked (HAW); all in the last 7 days.|At BL, 4-Month, 8-Month and 12-Month FUP|Source Population. Only par. with available data in each category (represented by n=X in the category title) were analyzed. Among the 101 par., 35 (35%) were retired and 59 (58%) were working. Only par. working were who completed the WPAI questionnaire were included in the analysis (56 at BL; 49 at 4 months; 37 at 8 months; 44 at FUP).||Hours||Standard Deviation|Mean
646189|NCT02153346|Primary|Indirect Cost of Asthma by Level of Asthma Severity Per Participant Per 3 Months at BL and 12-month FUP|Costs of asthma may vary depending on the participant’s asthma severity. Asthma severity was based on the standard definitions for severity and ACQ scores: Mild (<0.75), Moderate (>0.75) and Severe (any ACQ score). The following parameters were presented: Cost of absenteeism due to asthma (CAA), cost of presenteeism due to asthma (CPA), cost of absenteeism due to asthma in whom TCC was possible (CAA TCC), cost of presenteeism due to asthma in whom TCC was possible (CPA TCC), and total indirect cost due to asthma (TICA).|BL and 12-month FUP|Source Population. Only participants with available data in each category (represented by n=X in the category title) were analyzed. One third of the participants selected were retired. Only 59 participants were active workers. Therefore the stratification for asthma control and severity included very low numbers (52 at BL; 40 at FUP).||Canadian Dollars||Standard Deviation|Mean
646190|NCT02153346|Primary|Indirect Cost of Asthma by Level of Asthma Control Per Participant Per 3 Months at BL and 12-month FUP|Costs of asthma are greater when the asthma is sub-optimally managed and controlled and varies depending on the par. asthma control. Asthma control was assessed using the Asthma Control Questionnaire (ACQ) and par. were asked to recall their experiences during the previous week and respond to the 6 specified questions on a 7-point Likert scale (0=well-controlled; 6=maximum impairment [poorly controlled]; a score of ≤0.75 indicates well controlled symptoms. The following parameters were presented: Cost of absenteeism due to asthma (CAA), cost of presenteeism due to asthma (CPA), cost of absenteeism due to asthma in whom TCC was possible (CAA TCC), cost of presenteeism due to asthma in whom TCC was possible (CPA TCC), and total indirect cost due to asthma (TICA). Only 59 par. were active workers. When stratified by asthma control and severity each stratum had a sample less than 59. Although results are presented. data may not be reliable due to the low number of par. in each stratum.|BL and 12-month FUP|Source Population. Only participants with available data in each category (represented by n=X in the category title) were analyzed. One third of the participants selected were retired. Only 59 participants were active workers. Therefore the stratification for asthma control and severity included very low numbers (52 at BL; 40 at FUP).||Canadian Dollars||Standard Deviation|Mean
646257|NCT02151253|Secondary|Clinical Global Impressions, Change in Severity of Excessive Daytime Sleepiness (EDS)|Scale consists of a 7 point likert rating scale where the anchors were 1= ”normal”; 2= ”borderline sleepiness”; 3= ”mild sleepiness”; 4= ”moderate sleepiness”; 5= ”marked sleepiness”; 6= ”severe sleepiness”; and 7= ”among the most extremely sleepy individuals”|week 4, of each phase|||units on a scale||Standard Deviation|Mean
646191|NCT02153346|Primary|Indirect Cost of Asthma Per Participant Per 3 Months at Baseline (BL) and 12-month Follow-up (FUP)|Participants completed questionnaires within 2 weeks post-recruitment, 4, 8 and 12 months to measure indirect cost of disease, specifically related to productivity. The following questionnaires were used: WPAI helps to determine presenteeism, absenteeism, and total cost calculation (TCC) possible (number of days during the year of study), while VOLP is used to assess the impact of health conditions on lost productivity in monetary units (United states dollars). The following parameters were calculated: Cost of absenteeism due to asthma (CAA), cost of presenteeism due to asthma (CPA), cost of absenteeism due to asthma in whom TCC was possible (CAA TCC), cost of presenteeism due to asthma in whom TCC was possible (CPA TCC), and total indirect cost due to asthma (TICA).|BL and at 12-month FUP|Source Population: all par. with asthma diagnosed by respirologist and followed at outpatient asthma clinic of the HSCM and registered in BD-Asthma/RESP. Only par. with available data in each category (represented by n=X in the category title) were analyzed. One third of par. selected were retired. Only 59 were active workers (52 at BL; 40 at FUP).||US Dollars||Standard Deviation|Mean
646192|NCT02153099|Secondary|Terminal Elimination Half-life (T1/2) Pharmacokinetic Parameter for ENV8058 (TAK-058)|Terminal Phase Elimination Half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.|Predose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hours postdose|PK population included all enrolled participants.||hours||Standard Deviation|Mean
646193|NCT02153099|Secondary|AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for ENV8058 (TAK-058)|AUC(0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.|Predose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hours postdose|PK Population included all enrolled participants.||ng*hr/mL||Standard Deviation|Mean
646194|NCT02153099|Secondary|AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for ENV8058 (TAK-058)|(AUC(0-tlqc) is a measure of total plasma exposure to the drug from time 0 to time of the last quantifiable concentration (AUC[0-tlqc]).|Predose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hours postdose|PK Population included all enrolled participants.||ng*hr/mL||Standard Deviation|Mean
646195|NCT02153099|Secondary|Cmax: Maximum Observed Plasma Concentration for ENV8058 (TAK-058)|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Predose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hours postdose|Pharmacokinetic (PK) Population included all enrolled participants.||ng/mL||Standard Deviation|Mean
646196|NCT02153099|Primary|Percentage of Participants With Markedly Abnormal Vital Sign Measurements|The percentage of participants who meet markedly abnormal criteria for vital signs, including oral body temperature, respiration rate, pulse [beats per minute (bpm)], and resting blood pressure and after standing.|Baseline up to Day 14|Safety population included all enrolled participants who received at least 1 dose of study drug.||percentage of participants|||Number
646197|NCT02153099|Primary|Percentage of Participants With Markedly Abnormal Safety Laboratory Tests|The percentage of participants with any markedly abnormal standard safety laboratory values, including hematology, serum chemistries, and urinalysis, during the treatment period.|Baseline up to Day 14|Safety population included all enrolled participants who received at least 1 dose of study drug.||percentage of participants|||Number
646198|NCT02153099|Primary|Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)|Treatment-emergent adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after the last dose of study drug, or if a serious adverse event, within 30 days after the last dose of study drug.|Baseline up to Day 30|Safety population included all enrolled participants who received at least 1 dose of study drug.||percentage of participants|||Number
646199|NCT02153086|Secondary|Percentage of Participants Reported With Improvement on the PGI Scale for Daytime Physical Condition/Function|"Daytime physical condition/function was defined as general condition of participant throughout the day after adequate or prolonged night time sleep. PGI is a participant rated instrument to measure participant's change in overall status on a 7-point scale. Participants provide their response on a PGI questionnaire. Total score range from 1 (very much improved) to 7 (very much worse). Percentage of participants with improvement rated as much better or a little better were reported. The data was assessed at Week 4, Week 52 and final visit (follow up visit up to Month 12)."|At Week 4, 52, and final assessment (up to 12 months)|The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available.||percentage of participants|||Number
646200|NCT02153086|Secondary|Percentage of Participants Reported With Improvement on the PGI Scale for Daytime Somnolence|"Daytime somnolence was defined as excessive daytime sleepiness (EDS), characterized by general lack of energy, even after adequate or prolonged night time sleep. PGI is a participant rated instrument to measure participant's change in overall status on a 7-point scale. Participants provide their response on a PGI questionnaire. Total score range from 1 (very much improved) to 7 (very much worse). Percentage of participants with improvement rated as much better or a little better were reported. The data was assessed at Week 4, Week 52 and final visit (follow up visit up to Month 12)."|At Week 4, 52, and final assessment (up to 12 months)|The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available.||percentage of participants|||Number
646201|NCT02153086|Secondary|Percentage of Participants Reported With Improvement on the PGI Scale for Remaining Tiredness in the Morning|"Remaining tiredness in the morning was defined as an experience of fatigue after complete or adequate sleep duration. PGI is a participant rated instrument to measure participant's change in overall status on a 7-point scale. Participants provide their response on a PGI questionnaire. Total score range from 1 (very much improved) to 7 (very much worse). Percentage of participants with improvement rated as much better or a little better were reported. The data was assessed at Week 4, Week 52 and final visit (follow up visit up to Month 12)."|At Week 4, 52, and final assessment (up to 12 months)|The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available.||percentage of participants|||Number
648658|NCT02098109|Secondary|Comparison of the Most Commonly Reported Adverse Events (Safety) Experienced by Participants Between the Two Arms|-Adverse events will be assessed using CTCAE version 4.0|Up to 20 days after last apheresis (Day 25-Day 28)|||participants|||Number
646202|NCT02153086|Secondary|Percentage of Participants Reported With Improvement on the PGI Scale for Morning Awakening|"Morning awakening was defined as the return to the awaked state from any non-rapid eye movement (NREM) to rapid eye movement (REM) sleep stages in the morning. PGI is a participant rated instrument to measure participant's change in overall status on a 7-point scale. Participants provide their response on a PGI questionnaire. Total score range from 1 (very much improved) to 7 (very much worse). Percentage of participants with improvement rated as much better or a little better were reported. The data was assessed at Week 4, Week 52 and final visit (follow up visit up to Month 12)."|At Week 4, 52, and final assessment (up to 12 months)|The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available.||percentage of participants|||Number
646203|NCT02153086|Secondary|Percentage of Participants Reported With Improvement on the PGI Scale for Sleep Quality|"Sleep quality was defined as participants satisfaction of the sleep experience, integrating aspects of sleep initiation, sleep maintenance, sleep quantity, and refreshment upon awakening. PGI is a participant rated instrument to measure participant's change in overall status on a 7-point scale. Participants provide their response on a PGI questionnaire. Total score range from 1 (very much improved) to 7 (very much worse). Percentage of participants with improvement rated as much better or a little better were reported. The data was assessed at Week 4, Week 52 and final visit (follow up visit up to Month 12)."|At Week 4, 52, and final assessment (up to 12 months)|The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available.||percentage of participants|||Number
646204|NCT02153086|Secondary|Percentage of Participants Reported With Improvement on the PGI Scale for Sleep Duration|"Sleep duration was defined as the total amount of sleep obtained. PGI is a participant rated instrument to measure participant's change in overall status on a 7-point scale. Participants provide their response on a PGI questionnaire. Total score range from 1 (very much improved) to 7 (very much worse). Percentage of participants with improvement rated as much better or a little better were reported. The data was assessed at Week 4, Week 52 and final visit (follow up visit up to Month 12)."|At Week 4, 52, and final assessment (up to 12 months)|The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available.||percentage of participants|||Number
646205|NCT02153086|Secondary|Percentage of Participants Reported With Improvement on the Patient Global Impression (PGI) Scale for Sleep Onset|"Sleep onset was defined as the transition from wakefulness into sleep. PGI is a participant rated instrument to measure participant's change in overall status on a 7-point scale. Participants provide their response on a PGI questionnaire. Total score range from 1 (very much improved) to 7 (very much worse). Percentage of participants with improvement rated as much better or a little better were reported. The data was assessed at Week 4, Week 52 and final visit (follow up visit up to Month 12)."|At Week 4, 52, and final assessment (up to 12 months)|The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available.||percentage of participants|||Number
646206|NCT02153086|Secondary|Sleep Status: Number of Awakenings|Sleep status of participants was assessed and summarized by calculating the number of times participants had awaken from the time of start of the investigation. The data was assessed at baseline, Week 4 and final visit (last visit for a participant in the study, up to Month 12).|Baseline, Week 4 and Month 12|The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available.||number of awakenings||Standard Deviation|Mean
646207|NCT02153086|Secondary|Sleep Status: Total Sleep Time|Sleep status was determined by measuring the total sleep time, defined as the amount of actual sleep time during a sleep episode. The data was assessed at baseline, Week 4 and final visit (last visit for a participant in the study, up to Month 12).|Baseline, Week 4 and Month 12|The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available.||hours||Standard Deviation|Mean
646208|NCT02153086|Secondary|Sleep Status: Sleep Onset Latency|Sleep status was determined by measuring the sleep onset latency, defined as the length of time taken from lying down for the night until sleep onset. The data was assessed at baseline, Week 4 and final visit (last visit for a participant in the study, up to Month 12).|Baseline, Week 4 and Month 12|The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available.||minutes||Standard Deviation|Mean
646209|NCT02153086|Primary|Number of Participants Reporting One or More Adverse Drug Reactions|Adverse drug reactions are defined as adverse events (AEs) which are in the investigator’s opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.|Baseline up to 12 months|The safety analysis set was defined as all participants who were enrolled and completed the study.||participants|||Number
646210|NCT02152605|Secondary|Change From Baseline (BL) in Mean Number of Puffs of Rescue Medication Per Day Used Over Weeks 1-12|Albuterol/salbutamol(A/S) was used as rescue medication and was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout treatment periods. The number of puffs of rescue medication (A/S) per day over the entire 12 week treatment period was recorded and analyzed. For rescue use, ‘day’ is referred as the period between one record of rescue use and the next. Total puffs of rescue for each day = number of salbutamol puffs + (2 x number of salbutamol nebules). Analysis performed using mixed model repeated measures with covariates of BL(mean number of total puffs over the duration from First Day; defined as Latest of [7 days before Visit 2 and day after Visit 1] to Last Day(defined as Day before Visit 2)), smoking status, centre group, four-week period, treatment and period by BL interaction. Change from BL used weeks 1-4, 5-8, and 9-12 as covariates in the model and the overall least squares mean change for weeks 1-12 is estimated.|Week 1 amd Week 12|Intent-to-Treat (ITT) Population: all par. randomized to trt. who received at least one dose of randomized study drug. Par. represents all par. in the ITT population without missing covariate information and with at least one post BL measurement.||puffs per day||Standard Error|Least Squares Mean
646258|NCT02151253|Primary|Change From Baseline in Epworth Sleepiness Scale [ESS]|Epworth sleepiness scale (ESS) is measure of subjective sleepiness. Tendency to fall asleep in 8 situations. Total varies from zero to 24. A ESS of 10 or less is considered normal. Change is calculated as value at baseline minus value at week 4.|Baseline, Week 4 of each phase|||units on a scale||Standard Deviation|Mean
646211|NCT02152605|Secondary|Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Day 84|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 measurements were taken electronically by spirometry on Days 28, 56 and 84. Baseline is defined as the assessment taken pre-dose on Treatment Day 1. Trough FEV1 is defined as the FEV1 value obtained 24 hours after the previous morning's dosing. Change from Baseline at a particular visit was calculated as the trough FEV1 at that visit minus Baseline. Analysis was performed using a repeated measures model with covariates of treatment, Baseline , smoking status, center group, day, and day by Baseline and day by treatment interactions.|Baseline and Day 84|Intent-to-Treat (ITT) Population: all par. randomized to trt. who received at least one dose of randomized study drug. Par. represents those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis.||Liter||Standard Error|Least Squares Mean
646212|NCT02152605|Primary|Change From Baseline in Mean St.George’s Respiratory Questionnaire (SGRQ) Total Score at Day 84|The SGRQ is a disease-specific questionnaire, self-completed by participants(par), used to evaluate the effect of UMEC/VI on health-related quality of life as compared to placebo in par with COPD. The scores range from 0 (minimum, best possible health status) to 100 (maximum, worst possible health status). The SGRQ contains 76 items grouped into three domains (symptoms, activity and impacts). Analysis was performed using mixed model repeated measures with covariates of Baseline (scores recorded prior to dosing on Day 1) SGRQ total score, centre group, smoking status, Day, treatment(trt), Day by Baseline interaction and Day by trt interaction, where Day is nominal. Change from Baseline at a particular visit was calculated as the SGRQ total score at that visit minus Baseline. Change from Baseline in total score of -4 units or lower is considered as clinically meaningful improvement in quality of life.|Baseline and Day 84|Intent-to-Treat (ITT) Population: all par. randomized to trt. who received at least one dose of randomized study drug. Par. represents those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis.||Score on scale||Standard Error|Least Squares Mean
646213|NCT02152566|Primary|Treatment Efficacy|The primary endpoint of the trial is to the efficacy of using nasal high flow therapy to stabilize breathing, as measured by the breath flow signal from PSG.|During 1 night of Sleep on PSG|Out of 6 patient enrolled, 2 withdrew before participating in the study, 1 did not turn up to his appointment. From 3 participants who took part in the study,1 had a positive diagnosis of Cheyne-Stokes Respiration (CSR). The 1 patient who underwent treatment found the device too uncomfortable therefore no outcome measure data were available.|||||
646214|NCT02152371|Secondary|Rate of Hypoglycemic Events up to 28 Weeks|The rate of total hypoglycemic events any type per 30 days is presented. The hypoglycemia rate per 30 days during defined period is calculated by the number of hypoglycemia events within the period/number of days participant at risk within the period*30 days.|Baseline through 28 Weeks|All randomized participants who received at least 1 dose of study drug.||rate of hypoglycemic events per 30 days||Standard Deviation|Mean
646215|NCT02152371|Secondary|Percentage of Participants Achieving HbA1c Target of <7.0% and Without Weight Gain (<0.1 kg)||28 Weeks|All randomized participants who received at least 1 dose of study drug and had baseline and post-baseline HbA1c data. Last observation carried forward (LOCF) methodology was used to impute missing post-baseline values.||percentage of participants|||Number
646216|NCT02152371|Secondary|Percentage of Participants Achieving HbA1c Target of <7.0% at 28 Weeks and Without Documented Symptomatic Hypoglycemia During the Maintenance Period (Weeks 12-28)|Percentage of participants achieving target HbA1c of <7.0% at 28 weeks without documented symptomatic hypoglycemia are presented. Documented symptomatic hypoglycemia is defined as any time a participant experienced symptoms and or signs associated with hypoglycemia and had a plasma glucose of <=70 mg/dL.|28 Weeks|All randomized participants who received at least 1 dose of study drug and had baseline and post-baseline HbA1c data. Last observation carried forward (LOCF) methodology was used to impute missing post-baseline values||percentage of participants|||Number
646217|NCT02152371|Secondary|Percentage of Participants Achieving HbA1c Target of <7.0% and Without Weight Gain (<0.1 Kilograms [kg]) at 28 Weeks and Without Documented Symptomatic Hypoglycemia During the Maintenance Period (Weeks 12-28)|Percentage of participants who achieved a target HbA1c target of <7%, without weight gain and without documented symptomatic hypoglycemia at 28 weeks were analyzed using regression model, controlling for treatment, pre-treatment, baseline HbA1c and country.|28 Weeks|All randomized participants who received at least 1 dose of study drug and had baseline and post-baseline HbA1c data.Last observation carried forward (LOCF) methodology was used to impute missing post-baseline values.||percentage of participants|||Number
646218|NCT02152371|Secondary|Percentage of Participants Achieving HbA1c Targets of <7.0% or ≤6.5%|Percentage of participants who achieved HbA1c levels of <7% or ≤6.5% were analyzed using a logistic regression model, controlling for treatment, pre-treatment, baseline HbA1c and country.|28 Weeks|All randomized participants who received at least 1 dose of study drug and had a baseline and post-baseline HbA1c data. Last observation carried forward (LOCF) methodology was used to impute missing post-baseline values.||percentage of participants|||Number
646219|NCT02152371|Secondary|Number of Participants With Dulaglutide Anti-Drug Antibodies|Dulaglutide anti-drug antibodies (ADA) were assessed at baseline, Weeks 12 and 28. A participant was considered to have treatment-emergent (TE) dulaglutide ADAs if the participant had at least 1 titer that was TE relative to baseline, defined as a 4-fold or greater increase in titer from baseline measurement.|Baseline, Week 12 and Week 28|All randomized participants who received at least 1 dose of study drug and had at least one post-baseline Dulaglutide ADA test result.||participants|||Number
646220|NCT02152371|Secondary|Number of Participants With Thyroid Tumors/Neoplasms (Including C-Cell Hyperplasia)||Baseline through 28 Weeks|All randomized participants who received at least 1 dose of study drug.||participants|||Number
646221|NCT02152371|Secondary|Number of Participants With Adjudicated Acute Pancreatitis Events|The number of cases of acute pancreatitis confirmed by adjudication. A summary of serious and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.|Baseline through 28 Weeks|All randomized participants who received at least 1 dose of study drug.||participants|||Number
646222|NCT02152371|Secondary|Percentage of Participants Discontinuing the Study Due to Severe, Persistent Hyperglycemia||Baseline through 28 Weeks|All randomized participants who received at least 1 dose of study drug.||percentage of participants|||Number
646223|NCT02152371|Secondary|Percentage of Participants With Self-Reported Events of Hypoglycemia|Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of =<3.9 mmol/L), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of =<3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The percentage of participants with self-reported hypoglycemic events is presented.|Baseline through 28 Weeks|All randomized participants who received at least 1 dose of study drug.||percentage of participants|||Number
646224|NCT02152371|Secondary|Number of Participants With Investigator Reported and Adjudicated Cardiovascular Events|Cardiovascular (CV) adverse events (AEs) were adjudicated by an independent committee of physicians with cardiology expertise external to the sponsor. Deaths occurring during the study treatment period and nonfatal CV AEs were to be adjudicated. Nonfatal CV events that were to be adjudicated were myocardial infarction; hospitalization for unstable angina; hospitalization for heart failure; coronary interventions (such as coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI); and cerebrovascular events, including cerebrovascular accident (CVA/stroke), and transient ischemic attack (TIA).|Baseline through 28 Weeks|All randomized participants who received at least 1 dose of study.||participants|||Number
646225|NCT02152371|Secondary|Change From Baseline to 28 Weeks in Daily Mean Insulin Glargine Dose|Least Square (LS) Means of the insulin dose change from baseline to primary endpoint at week 28 was adjusted by treatment, country, metformin use, week, treatment-by-week interaction, and baseline insulin dose as covariate, via a MMRM analysis.|Baseline, 28 Weeks|All participants who one dose of study drug and had evaluable baseline and post-baseline insulin glargine data.||units (u)||Standard Error|Least Squares Mean
646226|NCT02152371|Secondary|Change From Baseline to 28 Weeks in Body Weight|LS means of the body weight change from baseline to primary endpoint at week 28 was adjusted by treatment, country, metformin use, week, treatment-by-week interaction, and baseline body weight as covariate, via a MMRM analysis.|Baseline, 28 Weeks|All participants who received at least one dose of study drug and had evaluable baseline and post-baseline body weight data.||kilogram(kg)||Standard Error|Least Squares Mean
646227|NCT02152371|Secondary|Change From Baseline to 28 Weeks in 7-Point Self Monitored Plasma Glucose (SMPG)|The LS means of the 7-point SMPG change from baseline to primary endpoint at week 28 was measured using a MMRM analysis adjusted by treatment, country, metformin use, week, treatment-by-week interaction, and baseline SMPG as covariate.|Baseline, 28 Weeks|All randomized participants who received at least 1 dose of study drug and had evaluable baseline and post-baseline SMPG data.||mg/dL||Standard Error|Least Squares Mean
646228|NCT02152371|Secondary|Change From Baseline to 28 Weeks in Fasting Serum Glucose (FSG)|FSG is a test to determine glucose levels after an overnight fast. LS means FSG change from baseline to primary endpoint at week 28 was calculated using a mixed effects model for repeated measures (MMRM) analysis adjusted by treatment, country, metformin use, week, treatment-by-week interaction, and baseline FSG as covariate.|Baseline, 28 Weeks|All participants who received at least one dose of study drug and had evaluable baseline and post-baseline FSG data.||milligram per deciliter (mg/dL)||Standard Error|Least Squares Mean
646229|NCT02152371|Primary|Change From Baseline to 28 Weeks in Hemoglobin A1c (HbA1c)|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least-squares (LS) mean and standard error (SE) changes from baseline in HbA1c at 28 weeks were measured using mixed model regression and restricted maximum likelihood (REML) with treatment, pooled country, visit, and treatment-by -visit interaction as fixed effects, baseline as covariate, and participant as a random effect.|Baseline, 28 Weeks|All participants who received at least one dose of study drug and had evaluable baseline and post- baseline HbA1c.||percentage of change||Standard Error|Least Squares Mean
646230|NCT02152007|Other Pre-specified|Standardized Photographs|An expert in the disease who is blinded to the study treatment will read the photographs of the callus area taken at each study visit. The reader will assess changes to the calluses based on criteria such as blisters, cracks, small/large size, and red or bloody spots on the callus. Change in calluses will be reported for both the right and left foot.|Each study visit over 39 weeks||||||
646231|NCT02152007|Other Pre-specified|Investigator Assessment of Local Tolerability|Investigator assessment of local tolerability at the application sites on the plantar surfaces will be evaluated by the Investigator according to a 4-point scale (0, 1, 2, or 3; none to severe) with regard to: erythema, pruritis, stinging/burning, and crusting/erosion|Prior to application of study drug and within 15-45 minutes after application of study drug at each visit for 39 weeks|||units on a scale||Standard Deviation|Mean
646232|NCT02152007|Secondary|Daily Assessments Recording in the PC Measurement Diary||Weekly for 39 weeks||||||
646233|NCT02152007|Secondary|Weekly Assessments Recorded in the PC Quality of Life Index|Patient-reported weekly assessment in the PC Quality of Life Index|Weekly for 39 weeks||||||
646234|NCT02152007|Primary|Evaluation of Systemic Absorption Through Measurement of Serum Sirolimus Trough Levels|The primary outcome measure for this Phase 1b safety study is evaluation of system absorption through measurement of serum sirolimus trough levels. The limit of detection of the assay was 2.0 ng/mL.|Two weeks and every 1-2 months for 24 weeks or within 2 weeks after the last dose of study drug|Starting at week 13, visit 4, there were only 14 participants with available data.||participants|||Number
646235|NCT02151994|Primary|Percentage (%) of Subjects With Treatment-Emergent Adverse Event (TEAE) Related to Study Medication (SM) - Food Effect (FE)|"Just before drug administration and twice daily until 72 h after (last) drug administration, subjects were asked non-leading questions to determine the occurrence of AEs. Subjects were asked in general terms about any AEs at regular intervals during each study period. In addition, all AEs reported spontaneously during the course of the study were recorded. All answers were assessed by the Medical Investigator (MI), coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 14.0) and recorded in the AEs Record. The intensity of the AEs was rated as mild, moderate or severe and the relationship between the AEs and the study medication was indicated as not related, unlikely, possible, probable or ''definite."|Just before drug administration and twice daily until 72 h after (last) drug administration|||% of subject with TEAEs related to SM|||Number
646236|NCT02151994|Primary|Percentage (%) of Subjects With Treatment-Emergent Adverse Event (TEAE) Related to Study Medication (SM) - Multiple Ascending Dose (MAD) Period|"Just before drug administration and twice daily until 72 h after (last) drug administration, subjects were asked non-leading questions to determine the occurrence of AEs. Subjects were asked in general terms about any AEs at regular intervals during each study period. In addition, all AEs reported spontaneously during the course of the study were recorded. All answers were assessed by the Medical Investigator (MI), coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 14.0) and recorded in the AEs Record. The intensity of the AEs was rated as mild, moderate or severe and the relationship between the AEs and the study medication was indicated as not related, unlikely, possible, probable or ''definite."|Just before drug administration and twice daily until 72 h after (last) drug administration|No drug-related TEAEs were reported for the dose levels of 50 mg md and 400 mg md.||% of subject with TEAEs related to SM|||Number
646237|NCT02151994|Primary|Percentage (%) of Subjects With Treatment-Emergent Adverse Event (TEAE) Related to Study Medication (SM) - Single Ascending Dose (SAD) Period|"Just before drug administration and twice daily until 72 h after (last) drug administration, subjects were asked non-leading questions to determine the occurrence of AEs. Subjects were asked in general terms about any AEs at regular intervals during each study period. In addition, all AEs reported spontaneously during the course of the study were recorded. All answers were assessed by the Medical Investigator (MI), coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 14.0) and recorded in the AEs Record. The intensity of the AEs was rated as mild, moderate or severe and the relationship between the AEs and the study medication was indicated as not related, unlikely, possible, probable or ''definite."|Just before drug administration and twice daily until 72 h after (last) drug administration|||% of subject with TEAEs related to SM|||Number
646238|NCT02151981|Other Pre-specified|Number of Deaths|Total number of deaths at the time of the analysis|From randomisation until death, up to 19 months (at the time of analysis).|Full Analysis Set (all randomised patients)||Number of participants|||Number
646239|NCT02151981|Secondary|Tumour Shrinkage by Investigator Assessment|Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Tumour size was calculated as the sum of the longest diameters (SLD) of the Target Lesions. Tumour shrinkage is percentage change in tumour size from baseline using RECIST v1.1 tumour response.|RECIST tumour assessments every 6 weeks from randomisation until objective disease progression up to 19 months (at the time of analysis).|Full Analysis Set (All randomised patients)||% change from baseline||Standard Deviation|Mean
646240|NCT02151981|Secondary|Disease Control Rate (DCR) by Investigator Assessment|Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions; Stable disease (SD): Neither sufficient shrinkage to qualify as a response nor sufficient growth to qualify as progression; Progressive Disease (PD): >= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of >=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. DCR is the percentage of patients with best response of CR, PR or SD at >=6 weeks, prior to any progressive disease (PD).|RECIST tumour assessments every 6 weeks from randomisation until objective disease progression up to 19 months (at the time of analysis).|Full Analysis Set (All randomised patients)||% of participants|||Number
646241|NCT02151981|Secondary|Duration of Response (DoR) by Investigator Assessment|Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. DoR is the time from the date of first documented response until the date of documented progression or death in the absence of disease progression.|RECIST tumour assessments every 6 weeks from randomisation until objective disease progression up to 19 months (at the time of analysis).|Full Analysis Set (All randomised patients)||months||95% Confidence Interval|Median
646242|NCT02151981|Secondary|Objective Response Rate (ORR) by Investigator Assessment|Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. ORR is the percentage of patients with at least 1 visit response of CR or PR prior to progression or any further therapy.|RECIST tumour assessments every 6 weeks from randomisation until objective disease progression up to 19 months (at the time of analysis).|Full Analysis Set (All randomised patients)||% of participants|||Number
646243|NCT02151981|Primary|Progression Free Survival (PFS) by Investigator Assessment|Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Progressive Disease (PD): >= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of >=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. PFS is the time from date of randomisation until the date of PD (by investigator assessment) or death (by any cause in the absence of progression) regardless of whether the patient withdrew from randomised therapy or received another anti-cancer therapy prior to progression. Patients who had not progressed or died at the time of analysis were censored at the time of the latest date of assessment from their last evaluable RECIST 1.1 assessment.|RECIST tumour assessments every 6 weeks from randomisation until objective disease progression up to 19 months (at the time of analysis).|Full Analysis Set (All randomised patients)||Months|Events|95% Confidence Interval|Median
646244|NCT02151786|Secondary|Percentage of Participants With Confirmed Hemostatic Effect Who Experienced Rebleeding After the Completion of Treatment|Rebleeding rate was reported as percentage of participants who experienced rebleeding after confirmed hemostasis by endoscopy and was calculated at 8 weeks after the completion of treatment with lansoprazole. It was calculated by dividing the percentage of the number of participants who experienced rebleeding after hemostasis divided by the total number of participants with confirmed hemostasis.|Week 8 after the last dose of study drug (Week 17)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.||percentage of participants|||Number
646275|NCT02150954|Primary|Time to Delivery|Time from foley balloon placement until neonate delivery|foley bulb placement until delivery (during admission for delivery, up to approximately 4 days)|||hours||Inter-Quartile Range|Median
646245|NCT02151786|Secondary|Percentage of Participants With Observed Hemostatic Effect Who Experienced Rebleeding After the Completion of Treatment|Rebleeding rate was reported as percentage of participants who experienced rebleeding after observed hemostasis and was calculated at 8 weeks after the completion of treatment with lansoprazole. It was calculated by dividing the percentage of the number of participants who experienced rebleeding after hemostasis divided by the total number of participants with observed hemostasis.|Week 8 after the last dose of study drug (Week 17)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.||percentage of participants|||Number
646246|NCT02151786|Secondary|Percentage of Participants Who Experienced Rebleeding After Confirmed Hemostatic Effect|Rebleeding rate was reported as percentage of participants who experienced rebleeding after confirmed hemostasis by endoscopy and was calculated during the period starting from baseline until the completion of treatment with lansoprazole. It was calculated by dividing the percentage of the number of participants who experienced rebleeding after hemostasis divided by the total number of participants with confirmed hemostasis.|Baseline up to Week 9|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.||percentage of participants|||Number
646247|NCT02151786|Secondary|Percentage of Participants Who Experienced Rebleeding After Observed Hemostatic Effect|Rebleeding rate was reported as percentage of participants who experienced rebleeding after observed hemostasis and was calculated during the period starting from baseline until the completion of treatment with lansoprazole. It was calculated by dividing the percentage of the number of participants who experienced rebleeding after hemostasis divided by the total number of participants with observed hemostasis.|Baseline up to Week 9|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.||percentage of participants|||Number
646248|NCT02151786|Secondary|Percentage of Participants With Confirmed Hemostatic Effect|Hemostatic effect was categorized on the basis of degree of improvement as: markedly improved, moderately improved, slightly improved and poor in the participants with confirmed hemostatic effect by endoscopy. Efficacy rate was reported as percentage of participants showing efficacy and was calculated as the sum of percentage of number of participants reporting markedly improved + moderately improved + slightly improved divided by the percentage of total number of participants with confirmed hemostatic effect.|Baseline up to Week 9|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.||percentage of participants|||Number
646249|NCT02151786|Secondary|Percentage of Participants With Observed Hemostatic Effect|Hemostatic effect was categorized on the basis of degree of improvement as: markedly improved, moderately improved, slightly improved and poor in the participants with observed hemostatic effect. Efficacy rate was reported as percentage of participants showing efficacy and was calculated as the sum of percentage of number of participants reporting markedly improved + moderately improved + slightly improved divided by the percentage of total number of participants with observed hemostatic effect.|Baseline up to Week 9|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.||percentage of participants|||Number
646250|NCT02151786|Primary|Number of Participants Reporting One or More Serious Adverse Drug Reactions|Serious adverse drug reactions are defined as serious adverse events (SAEs) which are in the investigator’s opinion of causal relationship to the study treatment. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to Week 9|The safety analysis set was defined as all participants who were enrolled and completed the study.||participants|||Number
646251|NCT02151786|Primary|Number of Participants Reporting One or More Adverse Drug Reactions|Adverse drug reactions are defined as adverse events (AEs) which are in the investigator’s opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.|Baseline up to Week 9|The safety analysis set was defined as all participants who were enrolled and completed the study.||participants|||Number
646252|NCT02151773|Secondary|Number of Participants Reporting One or More Adverse Drug Reactions|Adverse drug reactions are defined as adverse events (AE) which are in the investigator’s opinion of causal relationship to the study treatment. AE are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.|Baseline up to Day 28|Safety analysis set included all participants who received at least one dose of study vaccination.||participants|||Number
646253|NCT02151773|Primary|Number of Participants With Serious Adverse Drug Reactions|Serious adverse drug reactions are defined as serious adverse events (SAE) which are in the investigator’s opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Frequency of adverse events and factors that may influence safety were not to be assessed as endpoints of this study and were registered as endpoints by mistake. Instead, adverse drug reactions were assessed as endpoint.|Baseline up to Day 28|Safety analysis set included all participants who received at least one dose of study vaccination.||participants|||Number
646254|NCT02151253|Secondary|Mean Number of Nocturic Events (Episode of Urination Preceded and Followed by Sleep)|Nocturic Events is defined as an episode of urination preceded and followed by sleep. Measurements are for the preceding week|week 4 of each phase.|||Nocturic Events||Standard Deviation|Mean
646255|NCT02151253|Secondary|Mean Number of Minutes Napped Per Day Based on Sleep Diary|measurements are for the preceding week|week 4 of each phase.|||minutes napped per day||Standard Deviation|Mean
646256|NCT02151253|Secondary|Mean Number of Naps/Day|measurements are for the preceding week|week 4 of each phase.|||naps per day||Standard Deviation|Mean
646276|NCT02150954|Primary|Time to the Second Stage of Labor|The second stage of labor was defined as the time from complete cervical dilation to delivery of the fetus.|foley bulb placement until second stage of labor (during admission for delivery, up to approximately 4 days)|||hours||Inter-Quartile Range|Mean
646259|NCT02151058|Secondary|Lobene Stain Index Intensity Scores at Day 15|Tooth stain surface was assessed by using scores on the Lobene Stain Index scored 0 – 3, where 0= no stain, 1 = light stain, 2 = moderate stain, and 3 = heavy stain.|15 Days|Analysis was based on the Full Analysis Set, which included all randomized subjects who used study product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
646260|NCT02151058|Secondary|Lobene Stain Index Intensity Scores at Day 8|Tooth stain surface was assessed by using scores on the Lobene Stain Index scored 0 – 3, where 0= no stain, 1 = light stain, 2 = moderate stain, and 3 = heavy stain.|8 Days|Analysis was based on the Full Analysis Set, which included all randomized subjects who used study product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
646261|NCT02151058|Secondary|Lobene Stain Index Intensity Scores at Day 4|Tooth stain surface was assessed by using scores on the Lobene Stain Index scored 0 – 3, where 0= no stain, 1 = light stain, 2 = moderate stain, and 3 = heavy stain.|4 Days|Analysis was based on the Full Analysis Set, which included all randomized subjects who used study product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
646262|NCT02151058|Secondary|Lobene Stain Index Area Scores at Day 15|Tooth stain surface was assessed by using scores on the Lobene Stain Index scored 0 – 3, where 0= no stain, 1 = covering up to 1/3 of the region, 2 = covering > 1/3 to 2/3 of the region, and 3 = covering > 2/3 of the region.|15 Days|Analysis was based on the Full Analysis Set, which included all randomized subjects who used study product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
646263|NCT02151058|Secondary|Lobene Stain Index Area Scores at Day 8|Tooth stain surface was assessed by using scores on the Lobene Stain Index scored 0 – 3, where 0= no stain, 1 = covering up to 1/3 of the region, 2 = covering > 1/3 to 2/3 of the region, and 3 = covering > 2/3 of the region.|8 Days|Analysis was based on the Full Analysis Set, which included all randomized subjects who used study product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
646264|NCT02151058|Secondary|Lobene Stain Index Area Scores at Day 4|Tooth stain surface was assessed by using scores on the Lobene Stain Index scored 0 – 3, where 0= no stain, 1 = covering up to 1/3 of the region, 2 = covering > 1/3 to 2/3 of the region, and 3 = covering > 2/3 of the region.|4 Days|Analysis was based on the Full Analysis Set, which included all randomized subjects who used study product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
646265|NCT02151058|Secondary|Lobene Stain Index Composite Score at Day 8|"Tooth stain surface and stain intensity were assessed by using scores on the Lobene Stain Index (two part visual scale), scored 0 - 3. Where 0 = no stain, 1 = light stain, 2 = moderate stain and 3 = heavy stain. The second part of the scale examined the surface of the tooth on a scale of 0-3, where 0= no stain, 1 = covering up to 1/3 of the region, 2 = covering > 1/3 to 2/3 of the region and 3 = covering > 2/3 of the region.
The mean composite score (0-9) was determined by multiplying the individual tooth stain surface and stain intensity scores and summing then dividing by the number of regions scored for the subject (or tooth)."|8 Days|Analysis was based on the Full Analysis Set, which included all randomized subjects who used study product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
646266|NCT02151058|Secondary|Lobene Stain Index Composite Score at Day 4|"Tooth stain surface and stain intensity were assessed by using scores on the Lobene Stain Index (two part visual scale), scored 0 - 3. Where 0 = no stain, 1 = light stain, 2 = moderate stain and 3 = heavy stain. The second part of the scale examined the surface of the tooth on a scale of 0-3, where 0= no stain, 1 = covering up to 1/3 of the region, 2 = covering > 1/3 to 2/3 of the region and 3 = covering > 2/3 of the region.
The mean composite score (0-9) was determined by multiplying the individual tooth stain surface and stain intensity scores and summing then dividing by the number of regions scored for the subject (or tooth)."|4 Days|Analysis was based on the Full Analysis Set, which included all randomized subjects who used study product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
646267|NCT02151058|Primary|Lobene Stain Index Composite Score at Day 15|"Tooth stain surface and stain intensity were assessed by using scores on the Lobene Stain Index (two part visual scale), scored 0 - 3. Where 0 = no stain, 1 = light stain, 2 = moderate stain and 3 = heavy stain. The second part of the scale examined the surface of the tooth on a scale of 0-3, where 0= no stain, 1 = covering up to 1/3 of the region, 2 = covering > 1/3 to 2/3 of the region and 3 = covering > 2/3 of the region.
The mean composite score (0-9) was determined by multiplying the individual tooth stain surface and stain intensity scores and summing then dividing by the number of regions scored for the subject (or tooth)."|15 Days|Analysis was based on the Full Analysis Set, which included all randomized subjects who used study product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
646268|NCT02150954|Secondary|Neonatal Outcome: Late Fetal Heart Rate Decelerations|Late fetal heart rate decelerations were defined as a gradual decrease in the fetal heart rate associated with uterine contraction with the nadir of the deceleration occurring after the peak of the contraction.|during admission for delivery, up to approximately 4 days|||neonates|||Number
646269|NCT02150954|Secondary|Neonatal Outcome: Placental Abruption|number of participants with placental abruption|during admission for delivery, up to approximately 4 days|||participants|||Number
646270|NCT02150954|Secondary|Neonatal Outcome: Birthweight||at time of birth (0 to 1 hour)|||gram||Standard Deviation|Mean
646271|NCT02150954|Secondary|Incidence of Uterine Hyperstimulation|Uterine hyperstimulation (tachysystole) was defined as uterine contractions occurring greater than 12 in 20 minutes.|during admission for delivery, up to approximately 4 days|||participants|||Number
646272|NCT02150954|Secondary|Time to Foley Expulsion or Removal|Time from foley balloon placement until the expulsion or removal of the foley balloon.|foley bulb placement until removal, up to 10 hours|||hours||Inter-Quartile Range|Median
646273|NCT02150954|Secondary|Time to Active Labor|Active labor was defined as the presence of regular, painful contractions and a minimum of 2 cm cervical dilation and complete effacement in nulliparous women or a minimum of 4 cm cervical dilation in multiparous women.|during admission for delivery, up to approximately 4 days|||hours||Inter-Quartile Range|Median
646274|NCT02150954|Secondary|Rate of Cesarean Delivery|Number of participants having a cesarean delivery|during admission for delivery, up to approximately 4 days|||participants|||Number
646277|NCT02150499|Secondary|Number and Percentage of Subjects Determined to be Stabilized After Treatment|Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided.|Day 1||||||
646278|NCT02150499|Secondary|Change From Baseline in Pulmonary Score (Individual Component Scores) After Each Dose|Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided.|20 minutes, 40 minutes, 60 minutes||||||
646279|NCT02150499|Secondary|Change From Baseline in Pulmonary Score (Total Score) After Each Dose|Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided.|20 minutes, 40 minutes, 60 minutes||||||
646280|NCT02150499|Secondary|Change From Baseline in Pulmonary Score (Individual Component Scores) to End of Treatment|Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided.|Day 1||||||
646281|NCT02150499|Secondary|Change From Baseline in Pulmonary Score (Total Score) to End of Treatment|Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided.|Day 1||||||
646282|NCT02150499|Primary|The Overall Safety of Treatment With Levalbuterol Tartrate HFA Inhalation Aerosol as Measured by the Number of Subjects With Treatment-emergent Adverse Events Leading to Discontinuation.|Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided.|Week 1|||Number of Discontinuations|||Number
646283|NCT02150499|Primary|The Overall Safety of Treatment With Levalbuterol Tartrate HFA Inhalation Aerosol as Measured by the Number of Subjects With Serious Adverse Events.|Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided.|Week 1|||Number of Serious Adverse Events|||Number
646284|NCT02150499|Primary|The Overall Safety of Treatment With Levalbuterol Tartrate HFA Inhalation Aerosol as Measured by the Number of Subjects With Treatment-emergent Adverse Events.|Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided.|Week 1|||Number of Adverse Events|||Number
646285|NCT02150460|Primary|Pain Score for Cataract Surgery|Pain was scored on a 4 point scale: 1 - no pain, 2 - mild pain, 3 - moderate pain, 4 - severe pain|20 minutes|||units on a scale||Standard Deviation|Mean
646286|NCT02150460|Secondary|Duration of Cataract Surgery (Minutes)|Time interval from conjunctival incision to application of eye pad|At the end of surgery|||minutes||Standard Deviation|Mean
646287|NCT02150460|Secondary|Acceptability of the Anaesthetic Block to the Subject|Subjects were asked if they would agree to have the same anaesthetic procedure the next time they needed cataract surgery in the other eye|25 minutes|||participants|||Number
646288|NCT02150460|Secondary|Surgeon Satisfaction Score for Local Anaesthetic Block|Surgeon subjectively scored satisfaction with the anaesthetic block on a 4 point scale: 1- poor (25%), 2 - fair (50%), 3 - good (75%), 4 - excellent (100%)|20 minutes|||units on a scale||Full Range|Median
646289|NCT02150460|Secondary|Total Number of Injections|Total number of injections required to achieve an akinesia score of <4|15 minutes|||injections||Standard Deviation|Mean
646290|NCT02150460|Secondary|Volume of Anaesthetic Drug (ml)|Total volume of anaesthetic drug injected into the orbit to achieve anaesthesia and akinesia adequate for cataract surgery|10 and 15 minutes|||milliliters||Standard Deviation|Mean
646291|NCT02150460|Primary|Pain Score for Local Anaesthetic Injection|Pain was scored using a 4 point scale: 1 - no pain, 2 - mild pain, 3 - moderate pain, 4 - severe pain|20 minutes|||units on a scale||Standard Deviation|Mean
646292|NCT02150460|Primary|Complications of Local Anaesthetic Injection|"Systemic complications: dyspnoea, bronchospasm, impaired consciousness, intravascular injection etc
Local complications: eyelid oedema, corneal oedema, conjunctival chemosis, conjunctival haemorrhage, globe perforation, vitreous haemorrhage, orbital haemorrhage etc"|0,10 and 15 minutes|||participants|||Number
646293|NCT02150460|Primary|Supplementary Injection(s)|After 10 minutes if akinesia score was more than 3, supplementary injections were given and the effect assessed was 5 minutes later|5 minutes|||participants|||Number
646294|NCT02150460|Primary|Time Taken to Achieve Adequate Akinesia|Time taken to achieve akinesia and anesthesia adequate for surgery. Ability to move the eye in each of four directions (up, down, right and left) was scored thus: 2- normal movement, 1- reduced movement and 0- flicker or no movement. Upper eyelid akinesia was scored as 2- normal opening, 1- reduced movement and 0- complete immobility. Maximum score of 10 and minimum of 0. Adequate akinesia was defined as a total score of <4 and was evaluated at 10 and 15 minutes.|10 minutes and 15 minutes|||participants|||Number
646295|NCT02150213|Primary|Incidence of Uterine Endometrial Stromal Sarcomas|Incidence of uterine endometrial stromal sarcomas as assessed by sonogram/biopsy (females)|Minimum of one year after last dose of BGG492 in study BGG492A2207 or BGG492A2212|Full Analysis Set (FAS):included all patients who signed informed consent to enter the study, but this assessment was only done on female patients. Of the 31 female patients, two had a hysterectomy and were not evaluated (N=29)||Participants|||Number
646296|NCT02150213|Primary|Incidence of Adrenal Cortical Adenomas|Incidence of adrenal cortical adenomas as assessed by non-contrast MRI of the abdomen (CT or ultrasound of the abdomen was permitted if MRI was contraindication)|Minimum of one year after last dose of BGG492 in study BGG492A2207 or BGG492A2212|Full analysis Set: included all patients who signed informed consent to enter the study||Particpants|||Number
646297|NCT02150109|Secondary|Number of Subject Responses That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements|Staff obtained responses from subjects WITH and WITHOUT diabetes using short questionnaires to provide feedback on instructions for use and the basic operation of the BGMS. Subjects could respond 'Strongly Agree' or 'Agree' or 'Neutral' or 'Disagree' or 'Strongly Disagree.'|1 hour|||Number who strongly agree,agree,neutral|||Number
646298|NCT02150109|Secondary|Number of Subject Fingerstick Blood Glucose (BG) Results Within +/- 20% of Laboratory Glucose Method When Obtained and Tested by Study Staff|Study staff obtained and tested subject (WITH and WITHOUT diabetes) fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma results were used to calculate the number of BGMS results within +/-20% across the tested YSI glucose range.|1 hour|369 (372-3) Blood glucose results were analyzed. One (1) subject had no hematocrit result, required per protocol. For one subject staff test was not performed and for one subject staff test was not evaluable due to protocol deviation.||Blood glucose results within +/- 20%|||Number
646299|NCT02150109|Secondary|Number of Subject Fingerstick Blood Glucose (BG) Results Within +/- 15% of Laboratory Glucose Method When Obtained and Tested by Study Staff|Study staff obtained and tested subject (WITH and WITHOUT diabetes) fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma results were used to calculate the number of BGMS results within +/-15% across the tested YSI glucose range.|1 hour|369 (372-3) Blood glucose results were analyzed. One (1) subject had no hematocrit result, required per protocol. For one subject staff test was not performed and for one subject staff test was not evaluable due to protocol deviation.||Blood glucose results within +/- 20%|||Number
646300|NCT02150109|Secondary|Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 20% of Laboratory Glucose Method Across the Tested Glucose Range|Untrained subjects WITH diabetes (329) and WITHOUT diabetes (43) self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the number of BGMS results within +/-20% of the laboratory method across the entire tested YSI glucose range.|1 hour|365 (372-7) Blood glucose results were analyzed. One (1) subject had no hematocrit result, required per protocol. For one subject time between subject meter test and collection of subject reference sample exceeded time allowed in protocol. Five subjects did not obtain meter BG result after three attempts.||Blood glucose results within +/- 20%|||Number
646301|NCT02150109|Secondary|Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15% of Laboratory Glucose Method Across the Tested Glucose Range|Untrained subjects WITH diabetes (329) and WITHOUT diabetes (43) self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the number of BGMS results within +/-15% of the laboratory method across the entire tested YSI glucose range.|1 hour|365 (372-7) Blood glucose results were analyzed. One (1) subject had no hematocrit result, required per protocol. For one subject time between subject meter test and collection of subject reference sample exceeded time allowed in protocol. Five subjects did not obtain meter BG result after three attempts.||Blood glucose results within +/- 15%|||Number
646302|NCT02150109|Secondary|Number of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements|Staff obtained responses from persons WITH diabetes (329) using short questionnaires to provide feedback on instructions for use and the basic operation of the BGMS. Subjects could respond 'Strongly Agree' or 'Agree' or 'Neutral' or 'Disagree' or 'Strongly Disagree.'|1 hour|||number who strongly agree,agree,neutral|||Number
646303|NCT02150109|Secondary|Number of Fingerstick Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method When Obtained and Tested by Study Staff|Study staff obtained and tested subject (329 WITH diabetes) fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma results were used to calculate the number of BGMS results within +/-15 mg/dL (<100 mg/dL YSI capillary plasma) and +/-15% (>=100 mg/dL YSI capillary plasma).|1 hour|326 (329-3) Blood glucose results were analyzed. One (1) subject had no hematocrit result, required per protocol. One subject had no BG result obtained by study staff. One subject's staff-obtained BG result was not evaluable due to protocol deviation.||Blood glucose results within 15mg/dL/15%|||Number
646304|NCT02150109|Secondary|Number of Venous Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method|Study staff tested venous blood of subjects WITH diabetes (329) using an investigational Blood Glucose Monitoring System (BGMS). Venous BGMS results were compared with subject venous plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer venous plasma BG results were used to calculate the number of BGMS results within +/-15 mg/dL (<100 mg/dL YSI venous plasma) and +/-15% (>=100 mg/dL YSI venous plasma).|1 hour|318 (329-11) Blood glucose results were analyzed. Eleven (11) subjects had unsuccessful venipuncture attempts, so no venous results were obtained for them.||Blood glucose results within 15mg/dL/15%|||Number
646305|NCT02150109|Primary|Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method|Untrained subjects WITH diabetes (329) self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the number of BGMS results within +/-15 mg/dL (<100 mg/dL YSI capillary plasma) and +/-15% (>=100 mg/dL YSI capillary plasma).|1 hour|324 (329-5) Blood glucose results were analyzed. One (1) subject had no hematocrit result, required per protocol. For one subject time between subject meter test and collection of subject reference sample exceeded time allowed in protocol. Three subjects did not obtain meter BG result after three attempts.||Blood glucose results within 15mg/dL/15%|||Number
646306|NCT02150044|Secondary|Tube Retention|Tube Retention is the presence of a TTDS-placed tympanostomy tube across the tympanic membrane (TM) at the Follow-Up visit evaluated by ear. This endpoint was evaluated for the 13 study cohort subjects only (not the 16 lead-in subjects).|1 week|||ears|Participants||Number
646307|NCT02150044|Secondary|Procedure Success|Procedure Success is the successful placement of any tympanostomy tube evaluated on a per subject basis. This endpoint was evaluated for the 13 study cohort subjects only (not the 16 lead-in subjects).|Day 0 (at procedure visit)|||participants|||Number
648659|NCT02098109|Primary|Comparison of the Mean Day 5 CD34+Cells/kg Yield Between the Two Arms||Day 5|||cells/kg||Standard Deviation|Mean
646312|NCT02149342|Secondary|Pain Assesment (Visual Analog Scale)|Pain using visual analog scale (VAS 0-10, where 0 is no pain and 10 is the worst pain imaginable) on both treatment sides is assessed in every 30 minutes during 2-hour sun-exposure and afterwards once in two hours until 9 p.m. (treatment day). Of these values, the mean maximal pain is assessed.|12 hours|||Mean maximal pain VAS score||Full Range|Mean
646313|NCT02149342|Secondary|Adverse Reactions|Adverse reactions are evaluated by blinded observer at one week after treatment. Severity of the reaction ( Redness, crusting and scaling) is assessed using grading: minimal, mild, intermediate, severe.|One week|||participants|||Number
646314|NCT02149342|Secondary|Clinical Lesion Clearance|Clinical lesion clearance is observed by a blinded observer|Baseline, 3 months|||percentage of lesions in complete respon|Participants|Full Range|Mean
646315|NCT02149342|Primary|Histological Lesion Clearance|Punch biopsies were taken symmetrically on both treatment fields from equally graded >6 mm AKs prior to treatment and again at 3 months, blinded observer (pathologist). HE- and p53-stainings. Samples not fulfilling the criteria of an AK were defined as healthy or completely cleared. The p53 reactivity expressed as average percentage of positive nuclei in three consecutive high power fields from the region of highest reactivity (<10 % normal)|Baseline, 3 months|One patient was excluded from the histological analysis because one biopsied lesion clinically taken as an AK appeared histologically to be seborrheic eczema.||percentage of complete histological clea|Participants|Full Range|Mean
646316|NCT02149303|Primary|Index Event Characteristics (i.e. Type of Bleeding and Anatomic Locations of the Index Event) at the Time of the ED / ER Presentation or Hospitalization|"Proportion of Index events by anatomic location and type are presented. The categories of Unknown and Other presented below correspond to, Unknown: Unknown location of bleeding met the criteria for major bleeding as defined by the International Society on Thrombosis and Haemostasis (ISTH).
Other: Other types of bleeding represent a combined category of all other locations of bleeding whose incidence was <1.7%."|From the time of presentation / admission to an ED / ER or hospitalization through all in-hospital referrals until discharge (between 20 August 2014 (the date of the first data entry) and 4 March 2015 (the date of data entry closure)); Up to 196 days|Patients who received treatment at the five study sites||Percentage of events|||Number
646317|NCT02149303|Primary|Proportion of Subjects Receiving Different Types of Interventions (i.e., Medication / Procedure and Surgery) to Manage the Index Events Until Their Hospital Discharge / Release|Proportion of subjects receiving different types of interventions (i.e., medication / procedure and surgery) to manage the index events until their hospital discharge / release.|From the time of presentation / admission to an ED / ER or hospitalization through all in-hospital referrals until discharge (between 20 August 2014 (the date of the first data entry) and 4 March 2015 (the date of data entry closure)); Up to 196 days|Patients who received treatment at the five study sites||Percentage of participants|||Number
646318|NCT02149303|Primary|Proportion of Subjects With Index Event Safety Outcomes (Resolved / Recovery Ongoing / Deceased) at the Time of Their Hospital Discharge / Release.|Proportion of subjects with index event safety outcomes (resolved / recovery ongoing / deceased) at the time of their hospital discharge / release.|From the time of presentation / admission to an ED / ER or hospitalization through all in-hospital referrals until discharge (between 20 August 2014 (the date of the first data entry) and 4 March 2015 (the date of data entry closure)); Up to 196 days|Patients who received treatment at the five study sites||Percentage of participants|||Number
646345|NCT02148445|Secondary|Cotinine (Continued Smokers Only)|Cotinine over 12 months, adjusted for creatinine. At Month 3, Month 6, and Month 12, participants provided a urine sample that was used to assess their level of urinary creatinine and cotinine. This analysis looks at NNAL among continuing smokers only.|Month 3, Month 6, Month 12|n=4 deceased participants were excluded from analysis, non-smokers at each time point excluded||ng/mg creatinine||Standard Deviation|Geometric Mean
646329|NCT02149108|Secondary|Disease Control (Complete Response + Partial Response + Stable Disease) by Central Review Assessment|Disease control was defined as best overall response of CR, PR, or Stable Disease (SD).|From randomisation until cut-off date 14JUN2016.|Randomised Set: This patient set included all patients who were randomised to receive treatment, whether treated or not.||Percentage of participants|||Number
646330|NCT02149108|Secondary|Objective Tumour Response (Complete Response (CR)) + Partial Response (PR) by Central Review Assessment|Objective tumour response was defined as best overall response of CR or PR determined by central review assessment.|From randomisation until cut-off date 14JUN2016.|Randomised Set: This patient set included all patients who were randomised to receive treatment, whether treated or not.||Percentage of participants|||Number
646331|NCT02149108|Primary|Overall Survival (OS)|"OS was defined as the time from randomisation to the time of death from any cause.
Median, 95% Confidence Interval were calculated from an unadjusted Kaplan−Meier curve for each treatment arm."|From randomisation until cut-off date 14JUN2016.|Randomised Set: This patient set included all patients who were randomised to receive treatment, whether treated or not.||Months||95% Confidence Interval|Median
646332|NCT02149108|Primary|Progression-Free Survival (PFS) by Central Review Assessment|"PFS by central review assessment was defined as the time from the date of randomisation to the date of disease progression according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 or death from any cause, whichever occurred first.
Median, 95% Confidence Interval were calculated from an unadjusted Kaplan−Meier curve for each treatment arm."|From randomisation until cut-off date 14JUN2016.|Randomised Set: This patient set included all patients who were randomised to receive treatment, whether treated or not.||Months||95% Confidence Interval|Median
646333|NCT02148809|Other Pre-specified|Change IN Plasma Volume PV|"An indicator dilution technique was used to measure the blood volume, plasma volume and red cell blood volume. Approved by the Food and Drug Administration in 1998, the BVA-100 blood volume analyzer (Daxor Corp.) is a semi-automated system for blood volume analysis. Prepared standards and injectates were used. The injectate consists of 31I-labeled HSA (370– 1,295 kBq [10–30 mCi]) in saline.
Measurement was performed directly before surgery in the holding area and 6 hours after surgery.
Each time, before injection of the tracer a baseline sample was taken. After injection of the tracer via standard i.v. line, the first sample was drawn from an arterial line after 12 minutes waiting time. Afterwards every 6 minutes a sample was taken. In a whole 5 samples were sent for analysis to Daxor® Corp.. Each sample is counted in duplicate."|preoperative and 6 hours postoperatively|||ml||Standard Deviation|Mean
646334|NCT02148809|Primary|Change in Total Blood Volume|The primary outcome is the change in total blood volume (TBV) during the first 6 hours after primary THA utilizing hypotensive anesthesia. Preoperative TBV will be compared to values 6 hours postoperatively.|preoperatively and 6 hours postoperatively|||ml||Standard Deviation|Mean
646335|NCT02148718|Secondary|Correlation Between Clinical Response and Remission|Statistical analysis will be performed to evaluate the correlation between a clinical response at day 4 and week 1 with remission at week 12. Secondary outcome measures are to be analyzed at the time of the final analysis.|Up to Week 12||01/2018||||
646336|NCT02148718|Secondary|Change in Analytic Markers of Inflammation|Analytic markers include hemogram, erythrocytes sedimentation rate (ESR), C-reactive protein (CRP), fecal calprotectin and coagulation (including fibrinogen). Secondary outcome measures are to be analyzed at the time of the final analysis.|From Week 1 to Week 12||01/2018||||
646337|NCT02148718|Secondary|Fatigue Impact Scale for Daily Use (D-FIS): Change From Baseline to Each Visit|The D-FIS is used to measure the impact of fatigue on the daily lives of persons. The D-FIS overall score was calculated as the sum of eight items, each scored on a 0 to 4 point scale, and ranges from 0 to 32. A higher score indicates a higher impact of fatigue on daily life. A negative change in D-FIS Overall Score means an improvement in HRQoL due to fatigue. Secondary outcome measures are to be analyzed at the time of the final analysis.|Baseline (Week 0), Day 4, and Weeks 1, 2, 4, and 12||01/2018||||
646338|NCT02148718|Secondary|Inflammatory Bowel Disease Quality-36 (IBDQ-36) Questionnaire Overall Score: Change From Baseline to Each Visit|The IBDQ-36 is used to assess the HRQoL related to bowel symptoms. The IBDQ-36 overall score is calculated as the sum of thirty-six items, each scored on a 1 to 7 likert point scale, and ranges from 7 to 252. The highest score indicates the best HRQoL related to bowel symptoms. A positive change in IBDQ-36 overall score indicates an improvement in HRQoL due to inflammatory bowel disease. Secondary outcome measures are to be analyzed at the time of the final analysis.|Baseline (Week 0), Day 4, and Weeks 1, 2, 4, and 12||01/2018||||
646339|NCT02148718|Secondary|European Quality of Life (EuroQol) 5 Dimensions 3 Levels Questionnaire (EQ-5D-3L) Index Score: Change From Baseline to Each Visit|"The EQ-5D-3L is a standardized instrument for use as a measure of health-related quality of life (HRQoL)consists of 2 components:
The EQ-5D-3L Index Score has five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) with 3 levels of severity for each dimension ('no problems', 'some problems', and 'extreme problems'). The level of severity reported on each of the EQ-5D-3L dimensions determines a unique health state. Health states are converted into a weighted health state index. These weights lie on a scale on which full health has a value of 1 and dead has a value of 0. A positive change in the EQ-5D-3L index score indications an improvement in HRQoL
The EQ-5D VAS is a 20-cm scale with endpoints labeled best imaginable health and worst imaginable health anchored at 100 and 0, respectively.
Secondary outcome measures are to be analyzed at the time of the final analysis."|Baseline (Week 0), Day 4, and Weeks 1, 2, 4, and 12||01/2018||||
646340|NCT02148718|Secondary|Percentage of Participants With Clinical Remission at Weeks 2 and 4|Clinical remission defined as Harvey- Bradshaw Index < 5. The HBI consists of only clinical parameters (general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications): The first 3 items are scored for the previous day. Patients with Crohn's disease who scored 3 or less on the HBI are very likely to be in remission. Patients with a score of 8 to 9 or higher are considered to have severe disease. Secondary outcome measures are to be analyzed at the time of the final analysis.|Weeks 2 and 4||01/2018||||
646341|NCT02148718|Secondary|Percentage of Participants With Clinical Response at Week 1|Clinical response defined as a decrease of at least 3 points in the Harvey-Bradshaw Index (HBI) score. The HBI consists of only clinical parameters (general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications): The first 3 items are scored for the previous day. Patients with Crohn's disease who scored 3 or less on the HBI are very likely to be in remission. Patients with a score of 8 to 9 or higher are considered to have severe disease. Secondary outcome measures are to be analyzed at the time of the final analysis.|Week 1||01/2018||||
646342|NCT02148718|Primary|Percentage of Participants With Clinical Response at Day 4|Clinical response defined as a decrease of at least 3 points in the Harvey-Bradshaw Index (HBI) score. The HBI consists of only clinical parameters (general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications): The first 3 items are scored for the previous day. Patients with Crohn's disease who scored 3 or less on the HBI are very likely to be in remission. Patients with a score of 8 to 9 or higher are considered to have severe disease.|Day 4|Modified Intent to Treat (mITT) population: all participants enrolled in the study and received at least 1 dose of study drug.||percentage of participants||95% Confidence Interval|Number
646343|NCT02148523|Secondary|Morisky Medication Adherence Scale (MMAS)|"The secondary outcome will be subjects' self-reports medication adherence. Morisky et al. developed this 8-item MMAS (MMAS-8) in 2008. The first seven items are Yes/No responses while the last item is a 5-point Likert response. The scoring scheme is: “Yes” = 0 and “No” = 1 (and 0 = 0 and 1-4 = 1 for Likert question). The items are summed to give a range of scores from 0 to 8. Respondents' summed score get grouped as follows: 0 = High Adherence; 1-2 = Medium Adherence; 3-8 = Low Adherence."|90 days|||units on a scale||Inter-Quartile Range|Median
646344|NCT02148523|Primary|Statin Adherence|The primary outcome will be the percent of statin doses taken during the study as measured by the GlowCaps.|90 days|||percentage of correct statin doses||Standard Deviation|Mean
646402|NCT02146352|Primary|Safety/Adverse Event Outcome Measure 3|Freedom from surgery for access-site related perforation|Index procedure through 1-week post-stent removal|Entire patient cohort||percentage of patients|||Number
646346|NCT02148445|Secondary|Carcinogen Exposure (Continued Smokers Only)|Creatinine-adjusted NNAL (4-(methylnitrosamino)-1-(3)pyridyl-1-butanol)) exposure over 12 months. At Month 3, Month 6, and Month 12, participants provided a urine sample that was used to assess their level of urinary creatinine and NNAL. This analysis looks at NNAL among continuing smokers only.|Month 3, Month 6, Month 12|n=4 deceased participants were excluded from analysis, non-smokers at each time point excluded||pg/mg creatinine||Standard Deviation|Geometric Mean
646347|NCT02148445|Secondary|Carbon Monoxide Exposure (Continued Smokers Only)|Carbon monoxide (CO) exposure over 12 months. At Month 3, Month 6, and Month 12, participants completed an expired carbon monoxide laboratory test, which measured CO in parts per million. This analysis looks at CO among those continuing to smoke.|Month 3, Month 6, Month 12|n=4 deceased participants excluded from analysis, non-smokers at each time point excluded||parts per million (ppm)||Standard Deviation|Mean
646348|NCT02148445|Secondary|Average Cigarettes Per Day (Continued Smokers Only)|"Average number of cigarettes per day over one year, among continued smokers. All participants were asked During the past 7 days, on those days that you smoked, what was the average number of cigarettes smoked per day? at Month 3, Month 6, and Month 12. This analysis looks at the number of cigarettes per day among participants who were still smoking."|Month 3, Month 6, Month 12|n=4 deceased participants excluded from analysis, non-smokers at each time point excluded||cigarettes per day||Standard Deviation|Mean
646349|NCT02148445|Secondary|Cotinine|Cotinine over 12 months, adjusted for creatinine. At Month 3, Month 6, and Month 12, participants provided a urine sample that was used to assess their level of urinary creatinine and cotinine.|Month 3, Month 6, Month 12|n=4 deceased participants were excluded from analysis||ng/mg creatinine||Standard Deviation|Geometric Mean
646350|NCT02148445|Secondary|7-day Abstinence|"Self-reported and biochemically verified 7-day abstinence. Participants were asked at Month 3, Month 6, and Month 12, Have you smoked any cigarettes or little cigars, even a puff, in the past 7 days? They also completed an exhaled carbon monoxide lab test at Month 3, 6 and 12. Biochemical verification= exhaled CO <=10 ppm. Month 12 biochemically verified abstinence is the primary outcome, and is not reported in this table."|Month 3, Month 6, Month 12|n=4 deceased participants were excluded from analysis. Missing responses were coded as smokers.||Participants|||Count of Participants
646351|NCT02148445|Secondary|Cardiac-related Hospital Visits|Number of cardiac-related hospital admissions and emergency room visits. Participants were asked how many times they had visited the ED or were admitted to the hospital for cardiac-related problems at Month 3, Month 6, and Month 12.|Month 3, Month 6, Month 12|n=4 deceased participants excluded from analysis||Participants|||Count of Participants
646352|NCT02148445|Secondary|Respiratory-related Hospital Visits|Number of respiratory-related hospital admissions and emergency room visits. Participants were asked how many times they had visited the ED or were admitted to the hospital for respiratory-related problems at Month 3, Month 6, and Month 12|Month 3, Month 6, Month 12|n=4 deceased participants excluded from analysis||Participants|||Count of Participants
646353|NCT02148445|Secondary|Respiratory Symptoms|Respiratory symptoms as measured by the COPD Assessment Test (CAT) respiratory questionnaire. Participants completed this 8-item assessment at Month 3, Month 6, and Month 12. Scores range from 0 to 40, with higher levels indicating higher impact of COPD on well-being and daily life.|Month 3, Month 6, Month 12|n=4 deceased participants excluded from analysis||units on a scale||Standard Deviation|Mean
646354|NCT02148445|Secondary|Respiratory Function|Change in respiratory function, as measured by spirometry (FEV1), at 12 months post-randomization.|Month 12|n=4 deceased participants excluded from analysis. Participants with missing data excluded.||% of predicted||Standard Deviation|Mean
646355|NCT02148445|Secondary|Carcinogen Exposure|Creatinine-adjusted NNAL (4-(methylnitrosamino)-1-(3)pyridyl-1-butanol)) exposure over 12 months. At Month 3, Month 6, and Month 12, participants provided a urine sample that was used to assess their level of urinary creatinine and NNAL.|Month 3, Month 6, Month 12|n=4 deceased participants were excluded from analysis.||pg/mg creatinine||Standard Deviation|Geometric Mean
646356|NCT02148445|Secondary|Carbon Monoxide Exposure|Carbon monoxide (CO) exposure over 12 months. At Month 3, Month 6, and Month 12, participants completed an expired carbon monoxide laboratory test, which measured CO in parts per million.|Month 3, Month 6, Month 12|n=4 deceased participants excluded from analysis||parts per million (ppm)||Standard Deviation|Mean
646357|NCT02148445|Secondary|Average Cigarettes Per Day|"Average number of cigarettes per day over one year. Participants were asked at Month 3, Month 6, and Month 12 During the past 7 days, on those days that you smoked, what was the average number of cigarettes or little cigars smoked per day?"|Month 3, Month 6, Month 12|n=4 deceased participants excluded from analysis||cigarettes per day||Standard Deviation|Mean
646358|NCT02148445|Secondary|Quit Attempts|Number of self-reported quit attempts over one year. At Month 3 and Month 6, participants reported the number of quit attempts in the last 3 months. At Month 12, participants reported the number of quit attempts in the last 6 months.|Month 3, Month 6, Month 12|n=4 deceased participants were excluded from analysis.||number of quit attempts||Standard Deviation|Mean
646359|NCT02148445|Secondary|Sustained Abstinence|"6 month sustained abstinence as measured by self-report at 6 and 12 months and confirmed by CO at 6 and 12 months. Participants who were confirmed as non-smokers by carbon monoxide (CO) at both Month 6 and Month 12 were considered to have 6-month sustained abstinence."|Month 6 through Month 12|n=4 deceased participants were excluded from analysis. Missing values were counted as smokers.||Participants|||Count of Participants
646360|NCT02148445|Primary|Smoking Abstinence (Point Prevalent)|7-day point prevalent abstinence at 12 months, confirmed by exhaled CO <=10|Month 12|n=4 deceased participants were excluded from analysis. Missing values were counted as smokers.||Participants|||Count of Participants
646361|NCT02148107|Secondary|Cmax,ss (Maximum Measured Concentration of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t)|"Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t).
This endpoint could not be calculated as no PK blood samples were analysed due to the early termination of the study."|312 hours (h), 312 h 10 minutes (min), 312h 20min, 312h 40min, 313, 313h 30min, 314h, 315h, 316h, 318h, 320h, 322h, 324h and 336h after first drug administration|PK set. As no PK blood samples were analysed due to the early termination of the study, no PK parameters could be calculated and so the PK set contains 0 participants.|||||
646403|NCT02146352|Primary|Safety/Adverse Event Outcome Measure 2|Freedom from access site-related infection requiring intravenous or intramuscular antibiotics and/or extended hospitalization|Index procedure through 1-week post-stent removal|Entire patient cohort||percentage of patients|||Number
646362|NCT02148107|Secondary|AUCt,ss (Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t)|"AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t).
This endpoint could not be calculated as no PK blood samples were analysed due to the early termination of the study."|312 hours (h), 312 h 10 minutes (min), 312h 20min, 312h 40min, 313, 313h 30min, 314h, 315h, 316h, 318h, 320h, 322h, 324h and 336h after first drug administration|PK set. As no PK blood samples were analysed due to the early termination of the study, no PK parameters could be calculated and so the PK set contains 0 participants.|||||
646363|NCT02148107|Secondary|Cmax (Maximum Measured Concentration of the Analyte Inplasma)|"Cmax (maximum measured concentration of the analyte inplasma).
This endpoint could not be calculated as no PK blood samples were analysed due to the early termination of the study."|0 minutes (min), 10min, 20min, 40min, 1 hour (h), 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h and 24h after first drug administration|PK set. As no PK blood samples were analysed due to the early termination of the study, no PK parameters could be calculated and so the PK set contains 0 participants.|||||
646364|NCT02148107|Secondary|AUCt,1 (Area Under the Concentration-time Curve of the Analyte in Plasma Over a Uniform Dosing Interval t After Administration of the First Dose)|"AUCt,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval t after administration of the first dose).
This endpoint could not be calculated as no PK blood samples were analysed due to the early termination of the study."|0 minutes (min), 10min, 20min, 40min, 1 hour (h), 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h and 24h after first drug administration|PK set. As no PK blood samples were analysed due to the early termination of the study, no PK parameters could be calculated and so the PK set contains 0 participants.|||||
646365|NCT02148107|Primary|Percentage of Subjects With Drug-related Adverse Events|Percentage of subjects with drug-related Adverse events (AEs)|From the time of administration of the respective treatment until 21 days after last administration of study drug or start of the post-study phase to the respective treatment, up to 35 days|Treated set||Percentage of participants|||Number
646366|NCT02147691|Secondary|DLQI|Total scores range from 0 ( no impact on life over the last week) to 30 (maximum impact on life over the last week)|Week 12|||units on a scale||Standard Deviation|Mean
646367|NCT02147691|Secondary|DLQI|Total scores range from 0 ( no impact on life over the last week) to 30 (maximum impact on life over the last week)|Week 8|||units on a scale||Standard Deviation|Mean
646368|NCT02147691|Secondary|Dermatology Life Quality Index (DLQI)|Total scores range from 0 ( no impact on life over the last week) to 30 (maximum impact on life over the last week)|Week 4|||units on a scale||Standard Deviation|Mean
646369|NCT02147691|Secondary|VAS|participant measures erythema on a scale of 0 mm to 10 mm with 0 = to none and 10 = unbearable|Week 12|||units on a scale||Standard Deviation|Mean
646370|NCT02147691|Secondary|VAS|participant measures erythema on a scale of 0 mm to 10 mm with 0 = to none and 10 = unbearable|Week 8|||units on a scale||Standard Deviation|Mean
646371|NCT02147691|Secondary|Visual Analog Scale (VAS)|participant measures erythema on a scale of 0 mm to 10 mm with 0 = to none and 10 = unbearable|Week 4|||units on a scale||Standard Deviation|Mean
646372|NCT02147691|Secondary|Erythema|Erythema as measured by the clinician on a scale of 0-4, 0 = no erythema, 1 = slight pinkness, 2 = moderate, definite redness, easily recognized, 3 = severe, marked erythema and 4 = very severe, fiery red|Week 12|||units on a scale||Standard Deviation|Mean
646373|NCT02147691|Secondary|Erythema|Erythema as measured by the clinician on a scale of 0-4, 0 = no erythema, 1 = slight pinkness, 2 = moderate, definite redness, easily recognized, 3 = severe, marked erythema and 4 = very severe, fiery red|Week 8|||units on a scale||Standard Deviation|Mean
646374|NCT02147691|Secondary|Erythema|Erythema as measured by the clinician on a scale of 0-4, 0 = no erythema, 1 = slight pinkness, 2 = moderate, definite redness, easily recognized, 3 = severe, marked erythema and 4 = very severe, fiery red|Week 4|||units on a scale||Standard Deviation|Mean
646375|NCT02147691|Secondary|Lesion Counts||Week 12|||lesions||Standard Deviation|Mean
646376|NCT02147691|Secondary|Lesion Counts||Week 8|||lesions||Standard Deviation|Mean
646377|NCT02147691|Secondary|Lesion Count||Week 4|||lesions||Standard Deviation|Mean
646378|NCT02147691|Primary|IGA|Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe|Week 12|||units on a scale||Standard Deviation|Mean
646379|NCT02147691|Primary|IGA|Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe|Week 8|||units on a scale||Standard Deviation|Mean
646380|NCT02147691|Primary|IGA|Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe|Week 4|||units on a scale||Standard Deviation|Mean
646381|NCT02147691|Secondary|Dermatology Life Quality Index (DLQI)|The DLQI is a self-administered questionnaire consisting of 10 questions that measure how much the individual's skin problem has affected their life in the past week. Score ranges 0 through 30, 0 being none and 30 worst possible.|Baseline|||units on a scale||Standard Deviation|Mean
646382|NCT02147691|Secondary|Erythema Visual Analog Scale (VAS) Assessment (Subject)|Subjects will self assess the level of erythema over the previous 24 period using a scale of None (0) through 10 (Unbearable)|Baseline|||units on a scale||Standard Deviation|Mean
646383|NCT02147691|Secondary|Clinician's Erythema Assessment|Erythema will be graded on a scale of 0-4., 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 very severe. If erythema is much worse on one or several parts of the face, the grade for the worst area will be captured.|Baseline|||units on a scale||Standard Deviation|Mean
646384|NCT02147691|Secondary|Lesion Counts|The number of inflammatory lesions (papules/pustules) will be counted using the whole face from the hairline edge to the mandibular line|Baseline|||lesions||Standard Deviation|Mean
646385|NCT02147691|Primary|Investigator Global Assessment (IGA) at Baseline|Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe|Baseline|Only participants who were not lost to follow up or did not withdraw consent were included in the final analysis.||units on a scale||Standard Deviation|Mean
646386|NCT02147561|Secondary|Physician Global Assessment of Outcome on a 3-Point Scale|Physicians evaluated patient migraines as improved, no change, or worse compared to baseline.|Baseline, Day 28|Efficacy Population: patients enrolled in the study, who received study drug, and who had an efficacy assessment||Patients|||Number
648660|NCT02097992|Primary|Airway Blood Flow Reactivity (Delta Qaw)|percentage of change on airway blood flow induced by albuterol.|Immediate or 4 weeks|||% of change||Standard Error|Mean
646387|NCT02147561|Secondary|Change From Baseline in Headache Impact Test-6 (HIT-6) Total Score|The HIT-6 is a 6 question 5-point scale used to measure the impact of headaches on daily life. The total score ranged from 36 (no impact) to 78 (worst impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening.|Baseline, Day 28|Efficacy Population: patients enrolled in the study, who received study drug, and who had an efficacy assessment||Scores on a Scale||Standard Deviation|Mean
646388|NCT02147561|Primary|Percentage of Patients With Adverse Events|An Adverse Event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.|28 Days|Safety Population: patients enrolled in the study who received study drug||Percentage of Patients|||Number
646389|NCT02147522|Other Pre-specified|Change From Baseline in Self-Efficacy for Managing Chronic Disease (SEMCD) Score|The Self-Efficacy for Managing Chronic Disease (SEMCD) contains 6 items that are common across chronic diseases: symptom control, role function, emotional functioning and communicating with physicians, rated in a scale 1 (not at all confident) to 10 (totally confident). The score for the scale is the mean of the six items. Higher number indicates higher self-efficacy.|baseline, 6- and 12-month follow-ups|Some participants did not complete follow-up assessments (6-month: 48 AHH and 37 UC; 12-month: 56 AHH and 48 UC).||units on a scale||Standard Deviation|Mean
646390|NCT02147522|Secondary|Change From Baseline in MOS Short-Form Health Survey Physical Component Summary (PCS)|The Physical Component Summary (PCS) is a norm-based score standardized to the general U.S. population with a mean of 50, and a SD of 10. Scores range from 0 to 100, a higher score indicating better physical health.|baseline, 6- and 12-month follow-ups|Some participants did not complete follow-up assessments (6-month: 48 AHH and 37 UC; 12-month: 56 AHH and 48 UC).||units on a scale||Standard Deviation|Mean
646391|NCT02147522|Primary|Response Rate – 50 Percent or Greater Reduction in Patient Health Survey-9 (PHQ-9) Score Since Baseline|"The PHQ-9, which establishes provisional depressive disorder diagnosis as well as grades depressive symptom severity, will be obtained from all study subjects at recruitment and during the four waves of data collection (up to 12 months). The PHQ-9 scores each of the 9 DSM-IV criteria as 0 (not at all) to 3 (nearly every day), with possible scores ranging from 0 to 27, with cut points of 5,10,15, and 20 representing the thresholds for mild, moderate, moderately severe, and severe depression. A validated Spanish version of the PHQ-9 will be used. Clinically meaningful improvement of depressive symptoms was assessed as a ≥50% score reduction since baseline assessment."|6- and12-month follow-ups|Analyses for hypothesis testing related to the evaluation of AHH effects were carried out according to the intention-to-treat rule consistent with standard practice in clinical trials.||Participants|||Count of Participants
646392|NCT02147288|Primary|Post-operative Seroma Formation|Quantitative assessment of fluid collection in pre-defined anatomic regions will be performed via ultrasound examination approximately two weeks following removal of drains (either JP or NPWT-associated)|Two weeks following drain removal|Among 21 completers (standard of care group); one outlier was excluded from the analysis; 20 subjects were analyzed. Among 22 completers (experimental group), one outlier and 1 who did not have an ultrasound (i.e., fluid was not measured) were excluded, leaving 20 subjects for analysis.||cm^3||Full Range|Mean
646393|NCT02147093|Primary|Near LogMAR Visual Acuity|Near time controlled LogMAR Visual Acuity was carried out binocularly, at 4cm under 250 cd/m^2 and 50 cd/m^2 luminance. The test was presented on under the two conditions; High Luminance (250cd/m^2) High Contrast (90%) & Low Contrast (10%) and Low Luminance (50cd/m^2) High Contrast (90%)|7 days post wear|All subjects that completed all study visits without a major protocol deviation.||LogMAR||Standard Deviation|Mean
646394|NCT02147093|Primary|Distance LogMAR Visual Acuity|Distance time controlled LogMAR (Logarithm of the Minimum Angle of Resolution) Visual Acuity was carried out binocularly, at 4m (meter) under 250 cd/m^2 and 2.5 cd/m^2 (candela per square meter) luminance. The test was presented under the two conditions; High luminance (250 cd/m^2) High Contrast (90%) & Low Contrast (10%) and Low Luminance (2.5 cd/m^2) High Contrast (90%)|7 days post wear|All subjects that completed all study visits without a major protocol deviation.||LogMAR||Standard Deviation|Mean
646395|NCT02146599|Primary|Use of Corrective Visual Aids (i.e., Spectacles, Contact Lenses) Post Intraocular Lens (IOL) Surgery|Patients will be assessed at a baseline visit and a visit 1 week later to determine their use of corrective visual aids (i.e., spectacles, contact lenses) post Intraocular Lens (IOL) surgery.|Baseline and 1 week|Of the 295 participants who provided data for this analysis (monofocal participants , n=138; accommodating participants, n=34; and multifocal participants, n=123), corrective visual aids (i.e., spectacles, contact lenses) post intraocular lens (IOL) surgery were required by 88 participants.||participants|||Number
646396|NCT02146482|Secondary|Change in Pain in Other Body Parts|The Brief Pain Inventory (BPI) allows patients to rate the severity of their pain and the degree to which their pain interferes with common dimensions of feeling and function.|At the conclusion of each work day for 12 weeks and 8 weeks later||12/2016||||
646397|NCT02146482|Primary|Change in Back Pain|The Roland-Morris Disability Questionnaire is designed to assess self-rated physical disability caused by low back pain. The patient is asked to agree or disagree with 24 different statements related to their back pain. The end score is the sum of the agreed statements. The score ranges from 0 (no disability) to 24 (maximum disability).|Baseline (Week 1) and Follow-Up (Week 18)|||units on a scale||Full Range|Median
646398|NCT02146352|Secondary|Technical Success Outcome Measure 2|Technical Success: Successful removal of AXIOS stent using standard endoscopic snare or forceps|30 or 60 Day Post-procedure|Per Protocol||percentage of patients|||Number
646399|NCT02146352|Primary|Safety/Adverse Event Outcome Measure 6|Freedom from serious adverse event associated with the AXIOS stent and/or (index) implant procedure|Index procedure through 1-week post-stent removal|Entire patient cohort||percentage of patients|||Number
646400|NCT02146352|Primary|Safety/Adverse Event Outcome Measure 5|Freedom from tissue injury, defined as ulceration at site of stent implant as observed to persist through 1-week post-stent removal|Index procedure through 1-week post-stent removal|Patients for which AXIOS stent was removed and tissue at site of stent implant was observed at time of removal||percentage of patients|||Number
646401|NCT02146352|Primary|Safety/Adverse Event Outcome 4|Freedom from stent migration/dislodgement into the pseudocyst or enteral lumen|Index procedure through 1-week post-stent removal|Patients for which AXIOS stent migration/dislodgement could be assessed||percentage of patients|||Number
646409|NCT02146326|Secondary|Patient Engagement-Missed Appointments|Patient engagement was assessed by the proportion of missed appointments (when the client cancelled or did not show for a scheduled appointment divided by the total scheduled). This data was retrieved from client medical records at the agencies. Data from 3 time periods were analyzed (6 months prior to baseline through baseline, baseline to 6 months, and 6 months to 12 months). The below table illustrates the missed appointments for each time period.|Measured with clients at baseline, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to missing data (medical records not available) and clients discontinuing treatment at their respective agency.||appointments at mental health agency||Standard Deviation|Mean
646410|NCT02146326|Secondary|Quality of Care Total|Perceived Quality of Care was assessed with a 31 item scale (e.g., Staff spent extra time with me when I needed them.) and then refined to 22 items through data collected and analyzed in this study. This scale for clients was adapted from the one developed for staff. Item scores were averaged. Scale: 0 (never) to 5 (always)|Measured with clients at baseline, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.||units on a scale||Standard Deviation|Mean
646411|NCT02146326|Secondary|Quality of Care-Inattentive Care|Perceived Quality of Care was assessed with a 31 item scale (e.g., Staff spent extra time with me when I needed them.). This scale for clients was adapted from the one developed for staff. Inattentive care was measured with a subset of questions from this scale. Item scores were averaged. Scale: 0 (never) to 5 (always)|Measured with clients at baseline, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.||units on a scale||Standard Deviation|Mean
646412|NCT02146326|Secondary|Quality of Care-Negative Interactions|Perceived Quality of Care was assessed with a 31 item scale (e.g., Staff spent extra time with me when I needed them.). This scale for clients was adapted from the one developed for staff. Negative Interactions were measured with a subset of questions from this scale. Item scores were averaged. Scale: 0 (never) to 5 (always)|Measured with clients at baseline, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.||units on a scale||Standard Deviation|Mean
646413|NCT02146326|Secondary|Quality of Care-Person Centered Care|Perceived Quality of Care was assessed with a 31 item scale (e.g., Staff spent extra time with me when I needed them.). This scale for clients was adapted from the one developed for staff. Person Centered Care was measured with a subset of questions from this scale. The item scores were averaged. Scale: 0 (never) to 5 (always)|Measured with clients at baseline, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.||units on a scale||Standard Deviation|Mean
646414|NCT02146326|Secondary|Client Satisfaction Questionnaire|Engagement was assessed with patient satisfaction using the Client Satisfaction Questionnaire, an 8-item satisfaction checklist (e.g., How would you rate the quality of service you have received? and, If a friend were in need of similar help, would you recommend [name of agency] to him or her?). The item scores were averaged. Scale: 1 to 4 with response text dependent upon the question (e.g., 1-Poor to 4-Excellent, 1-No, definitely not to 4-Yes, definitely, or 1-Quite dissatisfied to 4-Very satisfied).|Measured with clients at baseline, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.||units on a scale||Standard Deviation|Mean
646415|NCT02146326|Secondary|Generalized Anxiety Disorder (GAD-7)|"Anxiety was assessed with the 7-item Generalized Anxiety Disorder (GAD-7). It can be scored continuously on a 0-21 severity scale and cutpoints have been established for estimating the probability of the 4 most common and clinically relevant anxiety disorders – generalized anxiety disorder, panic disorder, post-traumatic stress disorder, and social anxiety disorder. Scale: 0 (not at all), 1 (several days), 2 (more than half the days), 3 (nearly every day)
Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Archives of Internal Medicine. May 22 2006;166(10):1092-1097.
Kroenke K, Spitzer RL, Williams JB, Monahan PO, Lowe B. Anxiety disorders in primary care: prevalence, impairment, comorbidity, and detection. Ann Intern Med. Mar 6 2007;146(5):317-325."|Measured with clients at baseline, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.||units on a scale||Standard Deviation|Mean
646416|NCT02146326|Secondary|Patient Health Questionnaire 9-item (PHQ-9)|"The PHQ-9 is a brief, self-report assessment. It provides a summed total score that indicates likelihood of major depressive disorder. Scores ≥10 are considered a positive screen (sensitivity 88%, specificity 88%) and also effectively measures response to treatment (<5 indicate remission, of 5-9 indicate partial response, and ≥10 indicates no response). Item scores are summed and averaged (range: 0-27). Scale: 0 (Not at all), 1 (Several days), 2 (More than half the days), 4 (Nearly every day). When problems are identified, the difficulty of those problems are rated on 4 point scale (Not difficult at all to Extremely difficult).
Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. Journal of General Internal Medicine. Sep 2001;16(9):606-613.
American Psychiatric Association. Diagnostic and statistical manual of mental disorders - Text Revision (4th ed.). Washington, DC: American Psychiatric Association; 2000."|Measured with clients at baseline, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.||units on a scale||Standard Deviation|Mean
646417|NCT02146326|Secondary|Short-Form Health Survey (SF-12)-Mental Health Functioning|"Physical and mental health functioning was assessed with the Short Form 12-Item Health Survey (SF-12). The SF-12 is a health-related quality of life measure, derived from the 36-item Medical Outcomes Study survey and containing items yielding a Mental Health Component Score and a Physical Health Component Score. Higher composite scores indicate higher health-related quality of life. Items are weighted and then transformed into norm-based scores (range: 0-100).
Ware JE, Jr. , Kosinski M, Keller SD. A 12-item short-form health survey: Construction of scales and preliminary tests of reliability and validity. Medical Care. 1996;34(3):220 –233."|Measured with clients at baseline, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.||units on a scale||Standard Deviation|Mean
647515|NCT02121535|Primary|Cmax for Amlodipine|Cmax (maximum measured concentration of the analyte in plasma)|3hours(h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h, 96h, 120h, 144h after drug administration|PKS||ng/mL||Geometric Coefficient of Variation|Geometric Mean
646418|NCT02146326|Secondary|Short-Form Health Survey (SF-12)-Physical Health Functioning|"Physical and mental health functioning was assessed with the Short Form 12-Item Health Survey (SF-12). The SF-12 is a health-related quality of life measure, derived from the 36-item Medical Outcomes Study survey and containing items yielding a Mental Health Component Score and a Physical Health Component Score. Higher composite scores indicate higher health-related quality of life. Items are weighted and then transformed into norm-based scores (range: 0-100).
Ware JE, Jr. , Kosinski M, Keller SD. A 12-item short-form health survey: Construction of scales and preliminary tests of reliability and validity. Medical Care. 1996;34(3):220 –233."|Measured with clients at baseline, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.||units on a scale||Standard Deviation|Mean
646419|NCT02146326|Secondary|Patient Activation Measure-Mental Health (PAM-MH)-0 to 100 Scale|"Competence related to mental health management was assessed with the 13-item Patient Activation Measure-Mental Health (PAM-MH) (e.g., I know what each of my prescribed mental health medications does.). Each question was answered on a 4-point Likert-type scale: 1 (Strongly Disagree) to 4 (Strongly Agree). Higher scores=greater activation.
Hibbard JH, Mahoney ER, Stockard J, Tusler M. Development and testing of a short form of the patient activation measure. Health Services Research. Dec 2005;40(6 Pt 1):1918-1930."|Measured with clients at baseline, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.||units on a scale||Standard Deviation|Mean
646420|NCT02146326|Secondary|Working Alliance Inventory (WAI) - Bonds Subscale|"Perceived relatedness was assessed with this short form of the patient version of the WAI and has 12 items in total. This outcome is for the bonds subscale. Clients were prompted to report on the specific clinician from whose caseload they were randomly selected. The items scores were summed and averaged (range: 4-28). Scale: 1 (Never) to 7 (Always)
Tracey TJ, Kokotovic AM. Factor structure of the Working Alliance Inventory. Psychological Assessment: A Journal of Consulting and Clinical Psychology. 1989;1(3):207."|Measured with clients at baseline, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data. Some clients did not recall the clinician being asked about and/or discontinued treatment with that clinician during their study participation.||units on a scale||Standard Deviation|Mean
646421|NCT02146326|Secondary|Working Alliance Inventory (WAI) - Goals Subscale|"Perceived relatedness was assessed with this short form of the patient version of the WAI and has 12 items in total. This outcome is for the goals subscale. Clients were prompted to report on the specific clinician from whose caseload they were randomly selected. The items scores were summed and averaged (range: 4-28). Scale: 1 (Never) to 7 (Always)
Tracey TJ, Kokotovic AM. Factor structure of the Working Alliance Inventory. Psychological Assessment: A Journal of Consulting and Clinical Psychology. 1989;1(3):207."|Measured with clients at baseline, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data. Some clients did not recall the clinician being asked about and/or discontinued treatment with that clinician during their study participation.||units on a scale||Standard Deviation|Mean
646422|NCT02146326|Secondary|Working Alliance Inventory (WAI) - Tasks Subscale|"Perceived relatedness was assessed with this short form of the patient version of the WAI and has 12 items in total. This outcome is for the tasks subscale. Clients were prompted to report on the specific clinician from whose caseload they were randomly selected. The item scores were summed and averaged (range: 4-28). Scale: 1 (Never) to 7 (Always)
Tracey TJ, Kokotovic AM. Factor structure of the Working Alliance Inventory. Psychological Assessment: A Journal of Consulting and Clinical Psychology. 1989;1(3):207."|Measured with clients at baseline, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data. Some clients did not recall the clinician being asked about and/or discontinued treatment with that clinician during their study participation.||units on a scale||Standard Deviation|Mean
646423|NCT02146326|Secondary|Working Alliance Inventory (WAI)|"Perceived relatedness was assessed with this short form of the patient version of the WAI and is 12 items (e.g., We agree on what is important for me to work on.). Clients were prompted to report on the specific clinician from whose caseload they were randomly selected. The item scores were averaged. Scale: 1 (Never) to 7 (Always)
Tracey TJ, Kokotovic AM. Factor structure of the Working Alliance Inventory. Psychological Assessment: A Journal of Consulting and Clinical Psychology. 1989;1(3):207."|Measured with clients at baseline, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data. Some clients did not recall the clinician being asked about and/or discontinued treatment with that clinician during their study participation.||units on a scale||Standard Deviation|Mean
646424|NCT02146326|Secondary|Health-Care Climate Questionnaire|"Perceived autonomy support was assessed with this 15-item scale (e.g., I am able to be open with [name] at our meetings.). Clients were prompted to report on the specific clinician from whose caseload they were randomly selected. The item scores were averaged. Scale: 1 (Strongly Disagree) to 7 (Strongly Agree)
Williams GC, McGregor HA, King D, Nelson CC, Glasgow RE. Variation in perceived competence, glycemic control, and patient satisfaction: relationship to autonomy support from physicians. Patient Education & Counseling. Apr 2005;57(1):39-45."|Measured with clients at baseline, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data. Some clients did not recall the clinician being asked about and/or discontinued treatment with that clinician during their study participation.||units on a scale||Standard Deviation|Mean
646425|NCT02146326|Secondary|Medication Adherence Rating Scale (MARS) - Medication Attitudes - 10-item|"Medication attitudes (for clients who are prescribed medications for their mental health) was rated with the MARS, a 10-item scale assessing attitudes toward medication (e.g., It is unnatural for my mind and body to be controlled by medication.). The items scores were summed and averaged (range: 0-10). Scale: 0 (No) to 1 (Yes)
Thompson K, Kulkarni J, Sergejew AA. Reliability and validity of a new Medication Adherence Rating Scale (MARS) for the psychoses. Schizophrenia Research. May 5 2000;42(3):241-247."|Measured with clients at baseline, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out, clients who reported they are not prescribed medications for their mental health, and/or missing data.||units on a scale||Standard Deviation|Mean
649766|NCT02071849|Secondary|Mean Gradient - Change From Baseline|Transthoracic echocardiography parameter|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.||mm Hg||Standard Deviation|Mean
646426|NCT02146326|Secondary|Medication Adherence Rating Scale (MARS) - Medication Adherence - 4-item|"Medication adherence (for clients who are prescribed medications for their mental health) was rated with a subset of 4 items from the MARS, a 10-item scale assessing attitudes toward medication (e.g., Do you ever forget to take your medication? Are you careless at times about taking your medicine?). The item scores were summed and averaged (range: 0-4). Scale: 0 (No) to 1 (Yes)
Thompson K, Kulkarni J, Sergejew AA. Reliability and validity of a new Medication Adherence Rating Scale (MARS) for the psychoses. Schizophrenia Research. May 5 2000;42(3):241-247."|Measured with clients at baseline, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out, clients reporting they are not prescribed medications for their mental health, and/or missing data.||units on a scale||Standard Deviation|Mean
646427|NCT02146326|Secondary|Adult State Hope Scale|"Hope was assessed with clients using the 12-item Adult State Hope Scale (e.g., I can think of many ways to get the things in life that are most important to me.). The item scores were averaged. Scale: 1 (Definitely False) to 8 (Definitely True)
Snyder CR, Sympson SC, Ybasco FC, Borders TF, Babyak MA, Higgins RL. Development and validation of the State Hope Scale. Journal of Personality and Social Psychology. 1996;70(2):321 - 335."|Measured with clients at baseline, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.||units on a scale||Standard Deviation|Mean
646428|NCT02146326|Secondary|Staff Turnover|Number of staff participants who separated from their respective agency before their anticipated study completion date. The mental health agencies provided separation dates, if applicable, for staff study participants.|Measured with staff at 12 months|||Participants|||Count of Participants
646429|NCT02146326|Secondary|Perceptions of Supervisory Support|The 19 item Perceptions of Supervisory Support Scale was used to gather information on staff's experience of interactions with their supervisors (e.g., How often did you think supervision improved your relationship with your supervisor?). The item scores were averaged. Scale: 1 (never) to 6 (always)|Measured with staff at baseline, 3 months, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.||units on a scale||Standard Deviation|Mean
646430|NCT02146326|Secondary|Quality of Care-Total|Perceived Quality of Care was assessed with a 31 item scale developed with one of the mental health agencies participating in this project and then refined to 22 items through data collected and analyzed in this study. Items were related to person or client centered care, work conscientiousness, errors, interactions with clients, and how stress affects client interactions or outcomes. The item scores were averaged. Scale: 0 (never) to 5 (always)|Measured with staff at baseline, 3 months, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.||units on a scale||Standard Deviation|Mean
646431|NCT02146326|Secondary|Quality of Care: Discordant Care|Perceived Quality of Care was assessed with a 31 item scale developed with one of the mental health agencies as part of this project. Discordant Care was measured with a subset of questions from this scale (e.g., I had conflicts with clients.). The item scores were averaged. Scale: 0 (never) to 5 (always)|Measured with staff at baseline, 3 months, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.||units on a scale||Standard Deviation|Mean
646432|NCT02146326|Secondary|Quality of Care: Person Centered Care|Perceived Quality of Care was assessed with a 31 item scale developed with one of the mental health agencies as part of this project. Person Centered Care was measured with a subset of questions from this scale (e.g., I felt like I was able to really show compassion to a client.). The item scores were averaged. Scale: 0 (never) to 5 (always)|Measured with staff at baseline, 3 months, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.||units on a scale||Standard Deviation|Mean
646433|NCT02146326|Secondary|Confidence: Client Interaction|"Staff were asked, How confident are you that you can consistently interact with consumers/clients in a relaxed, non-judgmental way? Scale: 1 (not at all confident) to 10 (extremely confident)"|Measured with staff at baseline, 3 months, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.||units on a scale||Standard Deviation|Mean
646434|NCT02146326|Secondary|Importance: Client Interaction|"Staff were asked, How important is it for you to consistently interact with consumers/clients in a relaxed, non-judgmental way? Scale: 1 (not at all important) to 10 (extremely important)"|Measured with staff at baseline, 3 months, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.||units on a scale||Standard Deviation|Mean
646435|NCT02146326|Secondary|Confidence: Reduce Work-Related Stress|"Staff were asked, How confident are you that you can reduce your work-related stress in your life? Scale: 1 (not at all confident) to 10 (extremely confident)"|Measured with staff at baseline, 3 months, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.||units on a scale||Standard Deviation|Mean
646436|NCT02146326|Secondary|Importance: Reduce Work-Related Stress|"Staff were asked, How important is it for you to reduce your work-related stress right now? This single item score was averaged. Scale: 1 (not at all important) to 10 (extremely important)"|Measured with staff at baseline, 3 months, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.||units on a scale||Standard Deviation|Mean
646437|NCT02146326|Secondary|Emotional Labor Scale: Genuine Emotions|The Emotional Labor Scale includes 14 questions regarding the relationship between emotions and interactions with clients. Genuine Emotions is a subset of these questions (e.g., The emotions that I express to clients are genuine). The item scores were averaged. Scale: 1 (strongly disagree) to 5 (strongly agree)|Measured with staff at baseline, 3 months, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.||units on a scale||Standard Deviation|Mean
646481|NCT02145468|Secondary|Number of Participants Re-hospitalized Within 30 Days of Discharge|Participants who had a death or re-hospitalization within 30 days of discharge, plus participants who were never discharged from the initial hospitalization were included.|Within up to 30 days of post discharge|ITT Population||Participants|||Number
646438|NCT02146326|Secondary|Emotional Labor Scale: Deep Acting|The Emotional Labor Scale includes 14 questions regarding the relationship between emotions and interactions with clients. Deep Acting is a subset of these questions (e.g., I try to actually experience the emotions that I must show to clients). The item scores were averaged. Scale: 1 (strongly disagree) to 5 (strongly agree)|Measured with staff at baseline, 3 months, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.||units on a scale||Standard Deviation|Mean
646439|NCT02146326|Secondary|Emotional Labor Scale: Surface Acting|The Emotional Labor Scale includes 14 questions regarding the relationship between emotions and interactions with clients. Surface Acting is a subset of these questions (e.g., I put on an act in order to deal with clients in an appropriate way). The item scores were averaged. Scale: 1 (strongly disagree) to 5 (strongly agree)|Measured with staff at baseline, 3 months, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.||units on a scale||Standard Deviation|Mean
646440|NCT02146326|Secondary|Home Life Interference With Work|"Work-Life Balance was assessed with a six-item measure adapted from an 18-item measure developed by Carlson et al. The measure assesses three types (time-, strain-, and behavior-based) and two directions (work conflict with family and family conflict with work) of balance. The outcome described here is family conflict with work. The measure consists of a series of statements regarding one’s work and family situation, to which participants are asked to indicate their level of agreement or disagreement on a 5-point Likert-type scale: 1 (Strongly disagree) to 5 (Strongly agree). The item scores were averaged.
Carlson DS, Kacmar KM, Williams LJ. Construction and initial validation of a multidimensional measure of work–family conflict. Journal of Vocational Behavior. 2000;56(2):249-276."|Measured with staff at baseline, 3 months, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.||units on a scale||Standard Deviation|Mean
646441|NCT02146326|Secondary|Work Interference With Home Life|"Work-Life Balance was assessed with a six-item measure adapted from an 18-item measure developed by Carlson et al. The measure assesses three types (time-, strain-, and behavior-based) and two directions (work conflict with family and family conflict with work) of balance. The outcome described here is work conflict with family. The measure consists of a series of statements regarding one’s work and family situation, to which participants are asked to indicate their level of agreement or disagreement on a 5-point Likert-type scale: 1 (Strongly disagree) to 5 (Strongly agree). The item scores were averaged.
Carlson DS, Kacmar KM, Williams LJ. Construction and initial validation of a multidimensional measure of work–family conflict. Journal of Vocational Behavior. 2000;56(2):249-276."|Measured with staff at baseline, 3 months, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.||units on a scale||Standard Deviation|Mean
646442|NCT02146326|Secondary|Turnover Intentions-Likely to Leave|"This is the second of two questions in which staff were asked about turnover intentions. Staff were asked, How likely are you to leave your job in the next six months? Scale: 1 (Not likely at all), 2 (Not very likely), 3 (Somewhat likely), 4 (Very likely)"|Measured with staff at baseline, 3 months, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.||units on a scale||Standard Deviation|Mean
646443|NCT02146326|Secondary|Turnover Intentions-Considered Leaving|"This is the first of two questions in which staff were asked about turnover intentions. Staff were asked, How often have you seriously considered leaving your job in the past six months? Scale: 1 (Never), 2 (Once every few months), 3 (Once a month), 4 (several times a month), 5 (Once a week), 6 (Several times a week)"|Measured with staff at baseline, 3 months, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.||units on a scale||Standard Deviation|Mean
646444|NCT02146326|Secondary|Job Satisfaction|"Job satisfaction was assessed with one item from the Job Diagnostics Survey: Overall, I am satisfied with my job. Scale: 1 (Strongly Disagree) to 7 (Strongly Agree)
Hackman JR, Oldham GR. The Job Diagnostic Survey: An Instrument for the Diagnosis of Jobs and the Evaluation of Job Redesign Projects. 1974."|Measured with staff at baseline, 3 months, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.||units on a scale||Standard Deviation|Mean
646445|NCT02146326|Primary|Maslach Burnout Inventory (MBI): Personal Accomplishment|"Burnout was assessed with the Maslach Burnout Inventory (MBI), a widely-used measure of three components of burnout: emotional exhaustion, depersonalization, and personal accomplishment. The survey contains 22 statements of job-related feelings and staff were ased to read each statement and decide if they ever felt that way about their job. The item scores were averaged. Scale: 0 (Never), 1 (A few times a year or less), 2 (Once a month or less), 3 (A few times a month), 4 (Once a week), 5 (A few times a week), 6 (Every Day).
Maslach C, Jackson, S. E., Leiter, M. P. Maslach Burnout Inventory Manual. 3 ed. Palo Alto, California: Consulting Psychologists Press; 1996."|Measured with staff at baseline, 3 months, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.||units on a scale||Standard Deviation|Mean
646446|NCT02146326|Primary|Maslach Burnout Inventory (MBI): Depersonalization|"Burnout was assessed with the Maslach Burnout Inventory (MBI), a widely-used measure of three components of burnout: emotional exhaustion, depersonalization, and personal accomplishment. The survey contains 22 statements of job-related feelings and staff were ased to read each statement and decide if they ever felt that way about their job. The item scores were averaged. Scale: 0 (Never), 1 (A few times a year or less), 2 (Once a month or less), 3 (A few times a month), 4 (Once a week), 5 (A few times a week), 6 (Every Day).
Maslach C, Jackson, S. E., Leiter, M. P. Maslach Burnout Inventory Manual. 3 ed. Palo Alto, California: Consulting Psychologists Press; 1996."|Measured with staff at baseline, 3 months, 6 months, and 12 months|The number analyzed at each time point differs from the overall number due to participant drop out and/or missing data.||units on a scale||Standard Deviation|Mean
646482|NCT02145468|Secondary|Number of Participants With First Occurrence of Definite or Probable Stent Thrombosis Through to Week 12 and Week 24|Number of participants with first occurrence of definite or probable stent thrombosis through to Week 12 and Week 24 are presented. Participants receiving stent prior to randomization or during the study prior to Week 12 were included.|Week 12, Week 24|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, in the category titles).||Participants|||Number
646447|NCT02146326|Primary|Maslach Burnout Inventory (MBI): Emotional Exhaustion|"Burnout was assessed with the Maslach Burnout Inventory (MBI), a widely-used measure of three components of burnout: emotional exhaustion, depersonalization, and personal accomplishment. The survey contains 22 statements of job-related feelings and staff were asked to read each statement and decide if they ever felt that way about their job. The item scores were averaged. Scale: 0 (Never), 1 (A few times a year or less), 2 (Once a month or less), 3 (A few times a month), 4 (Once a week), 5 (A few times a week), 6 (Every Day).
Maslach C, Jackson, S. E., Leiter, M. P. Maslach Burnout Inventory Manual. 3 ed. Palo Alto, California: Consulting Psychologists Press; 1996."|Measured with staff at baseline, 3 months, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.||units on a scale||Standard Deviation|Mean
646448|NCT02146248|Other Pre-specified|Number of Participants With Bilateral Tubal Patency as Assessed by HSG -- Post DMPA Add Back COC HSG||HSG on OC after DMPA|||Participants|||Count of Participants
646449|NCT02146248|Other Pre-specified|Number of Participants With Bilateral Tubal Patency as Assessed by HSG - DMPA HSG|HSG during DMPA treatment|HSG on DMPA|||Participants|||Count of Participants
646450|NCT02146248|Other Pre-specified|Number of Participants With Bilateral Tubal Patency as Assessed by HSG - OC HSG|HSG during OC treatment|HSG on OC|||Participants|||Count of Participants
646451|NCT02146248|Primary|Number of Participants With Bilateral Tubal Patency as Assessed by HSG - Luteal|Assessment of patency at luteal phase exam|luteal phase HSG|||Participants|||Count of Participants
646452|NCT02146248|Primary|Number of Participants With Bilateral Tubal Patency as Assessed by HSG-follicular|Assessment of patency at follicular phase exam|follicular phase HSG|||Participants|||Count of Participants
646453|NCT02146105|Secondary|Change in Biomechanical Outcomes|Participants will be asked to partake in a complete kinematic, kinetic, and electromyographic analysis of gait and static postures using floor-embedded force plates, a 9-camera motion capture system, and a wireless electromyography system. Knee adduction moment (KAM; Nm/kg), normalized electromyography to a percentage of their maximal effort (%MVIC), and muscular co-activation (%) are the variables of interest.|Week 1 and Week 13||||||
646454|NCT02146105|Secondary|Change in Cardiovascular Fitness|Cardiovascular fitness is assessed using a sub maximal oxygen consumption cycle ergometer test. Heart rate is monitored using a Polar Heart Rate monitor and the test is terminated upon one of two conditions: a) volitional fatigue, or b) within 10 beats of 85% of the age-predicted maximum heart rate is achieved. Values are recorded in mL/kg/min.|Week 1 and Week 13||||||
646455|NCT02146105|Secondary|Change in Subjective Scales|The Centre of Epidemiologic Studies Depression Scale (19-items), the Athens Insomnia Scale (8-items), and the Perceived Stress Scale (10-items) will be given to the participants to gather information on feelings of depression, sleeping patterns, and perceived stress, respectively.|Week 1 and Week 13||||||
646456|NCT02146105|Secondary|Change in Stair Ascent and Descent|Participants are asked to climb a standard flight of 9 stairs as quickly and safely as possible without compromising safety. Stair ascent and descent are assessed individually. Time to climb the stairs are recorded (in seconds) and averaged over two trials.|Week 1 and Week 13||||||
646457|NCT02146105|Secondary|Change in Timed Up and Go (TUG)|Participants are asked to raise from a standard chair, walk forward 3-metres until an orange cone is reached, walk around the cone, then walk back to the chair and sit down. The test is to be completed as quickly and safely as possible without running. The trial is repeated a second time and the quickest time (in seconds) is recorded.|Week 1 and Week 13||||||
646458|NCT02146105|Secondary|Change in 30-second Chair Stand|Participants are asked to cross their arms over their chest and rise and sit back down in a chair as many times as possible in 30 seconds.|Week 1 and Week 13||||||
646459|NCT02146105|Secondary|Change in Six Minute Walk Test (6MWT)|Participants are asked to walk as far as possible for a total of six minutes at a self-selected pace in an obstruction-free rectangular hallway. Distance traveled is recorded in metres (m).|Week 1 and Week 13||||||
646460|NCT02146105|Primary|Change in Knee Pain|Knee pain is assessed subjectively via the Knee Injury and Osteoarthritis Outcome Score (KOOS) and the Intermittent and Constant Osteoarthritis Pain (ICOAP) questionnaires.|Week 1 and Week 13||||||
646461|NCT02146105|Primary|Change in Knee Extensor Torque|Knee extensor torque (Newton*meter) is calculated on a Biodex dynamometer using an isometric protocol. Trials are completed as a voluntary maximum effort.|Week 1 and Week 13|||Nm||Standard Deviation|Mean
646462|NCT02146001|Secondary|Change in Objectively-monitored Moderate-to-vigorous Physical Activity|Subjects will wear a BodyMedia SenseWearPro armband for 7 days during all waking hours at baseline and 12 weeks (same as for the primary outcome of sedentary behavior). This multi-sensor armband will give an estimate of time spent in moderate-to-vigorous physical activity over a 1 week period.|Change from baseline to 12 weeks|||bouted minutes/week||Standard Error|Least Squares Mean
646463|NCT02146001|Secondary|Change in Physical Function (Short Physical Performance Battery [SPPB])|Physical function will be assessed by the Short Physical Performance Battery including a chair stand test (timed test to stand up and down 5 times without using hands), a 4-meter walk test for gait speed, and a standing balance test. Standard scoring of the SPPB was used where each test contributes up to 4 points x 3 tests and the score can, therefore, range from 0 (worst) to 12 (best).|Change from baseline to 12 weeks|||points||Standard Error|Mean
646464|NCT02146001|Primary|Change in Objectively Monitored Sedentary Behavior|Subjects will wear a BodyMedia SenseWearPro armband for 7 days during all waking hours at baseline and 12 weeks. This multi-sensor armband will give an estimate of time spent in sedentary behavior over a 1 week period. Sedentary time will be averaged across days and reported as hours per day.|Change from baseline to 12 weeks|||hours/day||Standard Error|Least Squares Mean
646465|NCT02145754|Primary|Detection of Borrelia Burgdorferi Sensu Lato by Microscopy in Dark Field (Positive vs. Negative)|number of erythema migrans skin samples with Borrelia Burgdorferi sensu lato detected by Microscopy in Dark Field|weekly examination during 9 weeks of cultivating for individual specimen|Each participant provided two skin samples for analysis, one sample was cultivated in MKP, the other in BSK-H media.||culture-positive skin samples|||Number
646483|NCT02145468|Secondary|Number of Participants With First Occurrence of the Composite of CV Death or Type I (Spontaneous) MI Through to Week 12 and Week 24|Number of participants with first occurrence of the composite of CV death or type I (spontaneous) MI through to Week 12 and Week 24 are presented.|Week 12, Week 24|ITT Population||Participants|||Number
646466|NCT02145676|Secondary|Change From Baseline in the Self-Care Domain Score on the Spasticity Impact Assessment-Upper Limb (SIA-UL)|The SIA-UL asks the patient to assess the impact of upper limb spasticity in his/her daily life on a 19-item scale. The scale covers impacts on activities of dressing, showering/bathing, and self-care. The SIA score ranged from 0 (not at all difficult) to 4 (extremely difficult) for each question. The self-care domain was calculated based on the average of 4 questions.|Baseline, Week 6|Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received||Scores on a Scale||Standard Deviation|Least Squares Mean
646467|NCT02145676|Secondary|Change From Baseline in the Showering/Bathing Domain Score on the Spasticity Impact Assessment-Upper Limb (SIA-UL)|The SIA-UL asks the patient to assess the impact of upper limb spasticity his/her daily life on a 19-item scale. The scale covers impacts on activities of dressing, showering/bathing, and self-care. The SIA score ranged from 0 (not at all difficult) to 4 (extremely difficult) for each question. The showering/bathing domain was based on a single question.|Baseline, Week 6|Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received||Scores on a Scale||Standard Deviation|Least Squares Mean
646468|NCT02145676|Secondary|Change From Baseline in the Dressing Domain Score on the Spasticity Impact Assessment-Upper Limb (SIA-UL)|The SIA-UL asks the patient to assess the impact of upper limb spasticity in his/her daily life on a 19-item scale. The scale covers impacts on activities of dressing, showering/bathing, and self-care. The SIA score ranged from 0 (not at all difficult) to 4 (extremely difficult) for each question. The dressing domain was calculated based on the average of 2 questions.|Baseline, Week 6|Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received||Scores on a Scale||Standard Deviation|Least Squares Mean
646469|NCT02145676|Secondary|Change From Baseline in Pain on an 11-Point Scale|The patient is asked to select a number that best describes his/her pain in the treated areas of the study limb on an 11-point scale from 0 = “no pain” to 10 = “pain as bad as can be imagined”. Patients are instructed to recall their average pain in the study limb during the 48-hour period prior to the visit. Patients with a baseline pain score >0 are included in the analyses. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.|Baseline, Week 6|Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received||Scores on a Scale||Standard Deviation|Least Squares Mean
646470|NCT02145676|Secondary|Change From Baseline in the MAS-B Score of Shoulder Adductors Using a 6-Point Scale|The MAS-B is a 6-point scale used to evaluate spasticity based on grading the resistance encountered in the shoulder adductors by passively moving the shoulder adductor muscles through their range of motion. The score ranges from 0 (no increase in muscle tone) to 4 (affected part(s) rigid in flexion or extension). Scores are converted to a 0 to 5 grade. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.|Baseline, Week 6|Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received||Scores on a Scale||Standard Deviation|Least Squares Mean
646471|NCT02145676|Primary|Change From Baseline in the Modified Ashworth Scale-Bohannon (MAS-B) Score of Elbow Flexors Using a 6-Point Scale|The MAS-B is a 6-point scale used to evaluate spasticity based on grading the resistance encountered in the elbow flexors by passively moving the elbow flexor muscles through their range of motion. The score ranges from 0 (no increase in muscle tone) to 4 (affected part(s) rigid in flexion or extension). Scores are converted to a 0 to 5 grade. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.|Baseline, Week 6|Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received||Scores on a Scale||Standard Deviation|Least Squares Mean
646472|NCT02145468|Secondary|Number of Participants With First Occurrence of Any Unplanned Coronary Revascularization Through to Week 12 and Week 24|Number of participants with first occurrence of any unplanned coronary revascularization through to Week 12 and Week 24 are presented.|Week 12, Week 24|ITT Population||Participants|||Number
646473|NCT02145468|Secondary|Number of Participants With First Occurrence of Hospitalization for HF Through to Week 12 and Week 24|Number of participants with first occurrence of hospitalization for HF through to Week 12 and Week 24 are presented.|Week 12, Week 24|ITT Population||Participants|||Number
646474|NCT02145468|Secondary|Number of Participants With First Occurrence of Stroke (Fatal and Non-fatal) Events Through to Week 12 and Week 24|Number of participants with first occurrence of stroke (fatal and non-fatal) events through to Week 12 and Week 24 are presented.|Week 12, Week 24|ITT Population||Participants|||Number
646475|NCT02145468|Secondary|Number of Participants With First Occurrence of SRI-UR Events Through to Week 12 and Week 24|Number of participants with first occurrence of SRI-UR events through to Week 12 and Week 24 are presented.|Week 12, Week 24|ITT Population||Participants|||Number
646476|NCT02145468|Secondary|Number of Participants With First Occurrence of Type I (Spontaneous) MI Events Through to Week 12 and Week 24|Number of participants with first occurrence of type I (spontaneous) MI events through to Week 12 and Week 24 are presented.|Week 12, Week 24|ITT Population||Participants|||Number
646477|NCT02145468|Secondary|Number of Participants With First Occurrence of Myocardial Infarction (Fatal and Non-fatal) Events Through to Week 12 and Week 24|Number of participants with first occurrence of myocardial infarction (fatal and non-fatal) events through to Week 12 and Week 24 are presented.|Week 12, Week 24|ITT Population||Participants|||Number
646478|NCT02145468|Secondary|Number of Participants With CHD Death Events Through to Week 12 and Week 24|Number of participants with CHD death events through to Week 12 and Week 24 are presented.|Week 12, Week 24|ITT Population||Participants|||Number
646479|NCT02145468|Secondary|Number of Participants With CV Death Events Through to Week 12 and Week 24|Number of participants with CV death events through to Week 12 and Week 24 are presented.|Week 12, Week 24|ITT Population||Participants|||Number
646480|NCT02145468|Secondary|Number of Participants With All-cause Mortality Through to Week 12 and Week 24|Number of participants with all-cause mortality through to Week 12 and Week 24 are presented.|Week 12, Week 24|ITT Population||Participants|||Number
647990|NCT02111083|Primary|Pharmacokinetic Parameter: Maximum Serum Insulin Concentration (Cmax)||Day 1, predose through 8 hours post dose in each period|All participants who had at least one study treatment and had evaluable PK data.||picomole/liter (pmol/L)||Geometric Coefficient of Variation|Geometric Mean
646484|NCT02145468|Secondary|Number of Participants With First Occurrence of the Composite of CV Death, Type I (Spontaneous) MI or SRI-UR Through to Week 12 and Week 24|Number of participants with first occurrence of the composite of CV death, type I (spontaneous) MI or SRI-UR through to Week 12 and Week 24 are presented.|Week 12, Week 24|ITT Population||Participants|||Number
646485|NCT02145468|Secondary|Number of Participants With First Occurrence of the Composite of All-cause Death or MI Through to Week 12 and Week 24|Number of participants with first occurrence of the composite of all-cause death or MI through to Week 12 and Week 24 are presented.|Week 12, Week 24|ITT Population||Participants|||Number
646486|NCT02145468|Secondary|Number of Participants With First Occurrence of the Composite of All-cause Death, MI or SRI-UR Through to Week 12 and Week 24|Number of participants with first occurrence of the composite of all-cause death, MI or SRI-UR through to Week 12 and Week 24 are presented.|Week 12, Week 24|ITT Population||Participants|||Number
646487|NCT02145468|Secondary|Number of Participants With First Occurrence of the Composite of CHD Death or MI Through to Week 12 and Week 24|Number of participants with first occurrence of the composite of CHD death or MI through to Week 12 and Week 24 are presented.|Week 12, Week 24|ITT Population||Participants|||Number
646488|NCT02145468|Secondary|Number of Participants With First Occurrence of the Composite of CHD Death, MI or SRI-UR Through to Week 12 and Week 24|Number of participants with first occurrence of the composite of CHD death, MI or SRI-UR through to Week 12 and Week 24 are presented.|Week 12, Week 24|ITT Population||Participants|||Number
646489|NCT02145468|Secondary|Number of Participants With First Occurrence of the Expanded Composite of CV Death, MI, SRI-UR, Stroke or Hospitalization for HF Through to Week 12 and Week 24|Number of participants with first occurrence of the expanded composite of CV death, MI, SRI-UR, stroke or hospitalization for HF through to Week 12 and Week 24 are presented.|Week 12, Week 24|ITT Population||Participants|||Number
646490|NCT02145468|Secondary|Number of Participants With First Occurrence of the Composite of CV Death, MI or Stroke Through to Week 12 and Week 24|Number of participants with first occurrence of the composite of CV death, MI or stroke through to Week 12 and Week 24 are presented.|Week 12, Week 24|ITT Population||Participants|||Number
646491|NCT02145468|Secondary|Number of Participants With First Occurrence of the Composite of CV Death or Hospitalization for HF Through to Week 12 and Week 24|Number of participants with first occurrence of the composite of CV death or hospitalization for HF through to Week 12 and Week 24 are presented.|Week 12, Week 24|ITT Population||Participants|||Number
646492|NCT02145468|Secondary|Number of Participants With First Occurrence of the Composite of Coronary Events Defined as CHD Death, MI, SRI-UR or Any Unplanned Coronary Artery Revascularization Through to Week 12 and Week 24|Number of participants with first occurrence of the composite of coronary events defined as coronary heart disease (CHD) death, MI, SRI-UR or any unplanned coronary artery revascularization through to Week 12 and Week 24 are presented.|Week 12, Week 24|ITT Population||Participants|||Number
646493|NCT02145468|Secondary|Number of Participants With First Occurrence of the Expanded Composite of Arterial CV Events Defined as CV Death, MI, SRI-UR or Stroke Through to Week 12 and Week 24|Number of participants with first occurrence of the expanded composite of arterial CV events defined as CV death, MI, SRI-UR or stroke through to Week 12 and Week 24 are presented.|Week 12, Week 24|ITT Population||Participants|||Number
646494|NCT02145468|Secondary|Number of Participants With First Occurrence of the Composite of CV Death, MI or Hospitalization for Heart Failure (HF) up to Week 12 and Week 24.|Number of participants with first occurrence of the composite of CV death, MI or hospitalization for HF up to Week 12 and Week 24 are presented.|Week 12 and Week 24|ITT Population||Participants|||Number
646495|NCT02145468|Secondary|Number of Participants With First Occurrence of the Composite of CV Death or MI up to Week 12 and Week 24|Week 12 results are considered the principal secondary endpoint. Number of participants with first occurrence of the composite of CV death or MI up to Week 12 and Week 24 are summarized.|Week 12 and Week 24|ITT Population||Participants|||Number
646496|NCT02145468|Secondary|Number of Participants With First Occurrence of MACE Through Week 24|Number of participants with first occurrence of MACE through Week 24 including CV death, MI or SRI-UR are presented. Death for which the CEC or investigator were unable to establish cause were analyzed as CV deaths.|Up to Week 24|ITT Population.||Participants|||Number
646497|NCT02145468|Primary|Number of Participants With First Occurrence of Major Adverse Cardiovascular Events (MACE) Through Week 12|The primary efficacy endpoint is the composite measure of adjudicated MACE that includes the time to first occurrence of CV death (death due to a cardiovascular cause), MI or SRI-UR (Severe Recurrent Ischemia requiring Urgent coronary artery Revascularization). Death for which the Clinical Events Committee (CEC) or investigator were unable to establish cause were analyzed as CV deaths.|Up to 12 weeks|Intent-To-Treat (ITT) Population. ITT population comprised of all randomized participants.||Participants|||Number
646498|NCT02145299|Secondary|Angiographic Perforation Classification and Rate|"Evaluated in-hospital. The occurrence of any extravasation of contrast during the procedure (detected by the physician performing the procedure, or preferentially the Angiographic Core Laboratory) will be tabulated according to the standard Type 1-3 classification. Type 1 – Extraluminal crater without contrast extravasation
Type 2 – Perivascular blush without contrast jet extravasation
Type 3 – Contrast jet extravasation through frank (≥1 mm) perforation"|Day of operation|These data were not fully captured and summarized as the study was terminated.|||||
646499|NCT02145299|Secondary|Target Vessel Revascularization|A repeat revascularization procedure (percutaneous or surgical) of the index procedure target vessel. TVR is classified as clinically-driven if the repeat intervention is driven by clinical findings (ischemic symptoms).|30 days post operation|||percentage of participants|||Number
646500|NCT02145299|Secondary|Ankle-brachial Index (ABI)|The ratio of systolic blood pressure at the ankle to systolic blood pressure in the arm|baseline to 30 days post operation|||ratio||Standard Deviation|Mean
646501|NCT02145299|Secondary|Target Lesion Revascularization|Describes the percentage of patients that had stented lesions that had to be re-treated due to clinically-driven restenosis.|30 days post operation|||percentage of participants|||Number
646502|NCT02145299|Secondary|Index Limb Amputation|Need for limb amputation|Day of Operation through 30 days post operation|||participants|||Number
648545|NCT02100514|Secondary|Absolute Change From Baseline in Fasting Lipoprotein (A) (Lp[A]) at Week 12||Baseline, Week 12|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."||mg/dL||Standard Deviation|Mean
646503|NCT02145299|Secondary|Walking Capacity|"Change in walking capacity from baseline to 30 days, measured by the Walking Impairment Questionnaire. The questionaire is a subjective measure of patient-perceived walking performance developed for individuals with peripheral arterial disease. Used to evaluate the change in walking capacity study endpoint."|Baseline and 30 days post operation|These data were not fully captured and summarized as the study was terminated.|||||
646504|NCT02145299|Secondary|Symptomatic Improvement|Symptomatic improvement, as assessed by change in Rutherford Class from baseline to 30 days|Baseline, and 30 days post operation|||percentage of participants|||Number
646505|NCT02145299|Secondary|Clinical Success|Clinical Success defined as procedure success in the absence of in-hospital all-cause death, index limb amputation above the ankle, and TLR.|Day of operation|These data were not fully captured and summarized as the study was terminated.|||||
646506|NCT02145299|Secondary|Procedural Success|Procedural success, defined as technical success and (1) residual stenosis <50% in the treated segment (2) and improved distal flow by angiography following the procedure|Day of operation|Due to early study termination for reason unrelated to safety, rather enrollment challenges, part the Procedural Success definition required % residual stenosis which was going to be a Core Laboratory assessment to eliminate bias and maintain consistency in the analysis. With only 8 subjects enrolled, laboratory analysis was not undertaken.|||||
646507|NCT02145299|Primary|In-hospital Safety|In-hospital safety, defined as a composite of all-cause death, index limb amputation above the ankle, and target lesion revascularization (TLR)|Operation through 30 day follow up|||percentage of participants|||Number
646508|NCT02145299|Primary|Technical Success|Technical success, defined as the ability to facilitate complete intraluminal crossing of a CTO into the true distal lumen with a TruePath or a CROSSER device and/or any subsequent conventional guidewire, as confirmed by IVUS imaging|Day of operation|||percentage of participants|||Number
646509|NCT02145156|Primary|Number of Adolescents Who Completed the HPV Vaccine Series Among Those Who Initiated the Series During the Study Period|This outcome describes the number of adolescent participants between the ages of 9-17 who had 0 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.|16 months|Includes adolescents in the sample who could be matched to vaccination data, who had not received all 3 doses of the HPV vaccine prior to baseline, and who also had 0 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.||participants|||Number
646510|NCT02145156|Primary|Number of Adolescents Who Completed the HPV Vaccine Series During the Study Period, Among Those Who Initiated the Series at Study Start|This outcome describes the number of adolescent participants between the ages of 9-17 who had 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.|16 months|Includes adolescents in the sample who could be matched to vaccination data, who had not received all 3 doses of the HPV vaccine prior to baseline, and who also had 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.||participants|||Number
646511|NCT02145156|Primary|Number of Adolescents, Among All Eligible, Who Completed the HPV Vaccine Series During the Study Period|This outcome describes the number of adolescent participants between the ages of 9-17 who had 0, 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.|16 months|Includes adolescents in the sample who could be matched to vaccination data, who had not received all 3 doses of the HPV vaccine prior to baseline, and who also had 0, 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.||participants|||Number
646512|NCT02145156|Primary|Number of Adolescents Who Initiated But Did Not Complete the HPV Vaccine Series During the Study Period|This outcome describes the number of adolescent participants between the ages of 9-17 who had 0 doses of the HPV vaccine at study enrollment and did not complete the vaccine series during the study period.|16 months|Includes adolescents in the sample who could be matched to vaccination data, who had not received all 3 doses of the HPV vaccine prior to baseline, and who also had 0 doses of the HPV vaccine prior to baseline and did not complete the vaccine series during the study period.||participants|||Number
646513|NCT02145156|Primary|Number of Adolescents Who Initiated the HPV Vaccine Series During the Study Period|This outcome describes the number of adolescent participants between the ages of 9-17 who had 0 doses of the HPV vaccine at study enrollment and received at least one dose during the study period.|16 months|Includes adolescents in the sample who could be matched to vaccination data, who had not received all 3 doses of the HPV vaccine prior to baseline, and who also had 0 doses of the HPV vaccine prior to baseline.||participants|||Number
646514|NCT02145156|Primary|Number of Adolescents Who Received Any Dose of the HPV Vaccine During the Study Period|This outcome describes the number of adolescent participants between the ages of 9-17 who received any dose of the HPV vaccine during the study period.|16 months|Includes adolescents in the sample who could be matched to vaccination data and had not received all 3 doses of the HPV vaccine prior to baseline.||participants|||Number
646515|NCT02145156|Primary|Number of Young Adults Who Completed the HPV Vaccine Series Among Those Who Initiated the Series During the Study Period|This outcome describes the number of young adult participants between the ages of 18-26 who had 0 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.|16 months|Includes young adults in the sample who could be matched to vaccination data, who had not received all 3 doses of the HPV vaccine prior to baseline, and who also had 0 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.||participants|||Number
646516|NCT02145156|Primary|Number of Young Adults Who Completed the HPV Vaccine Series During the Study Period, Among Those Who Initiated the Series at Study Start|This outcome describes the number of young adult participants between the ages of 18-26 who had 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.|16 months|Includes young adults in the sample who could be matched to vaccination data, who had not received all 3 doses of the HPV vaccine prior to baseline, and who also had 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.||participants|||Number
646559|NCT02143141|Secondary|Nausea/Vomiting|The nausea/vomiting assessment is made using a Visual Analog Scale (VAS). VAS is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. Scale ranges from 0 indicating no nausea/vomiting to 100 indicating the most severe nausea/vomiting.|24 hours|||units on a scale||Standard Deviation|Mean
646517|NCT02145156|Primary|Number of Young Adults, Among All Eligible, Who Completed the HPV Vaccine Series During the Study Period|This outcome describes the number of young adult participants between the ages of 18-26 who had 0, 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.|16 months|Includes young adults in the sample who could be matched to vaccination data, who had not received all 3 doses of the HPV vaccine prior to baseline, and who also had 0, 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.||participants|||Number
646518|NCT02145156|Primary|Number of Young Adults Who Initiated But Did Not Complete the HPV Vaccine Series During the Study Period|This outcome describes the number of young adult participants between the ages of 18-26 who had 0 doses of the HPV vaccine at study enrollment and did not complete the vaccine series during the study period.|16 months|Includes young adults in the sample who could be matched to vaccination data, who had not received all 3 doses of the HPV vaccine prior to baseline, and who also had 0 doses of the HPV vaccine prior to baseline and did not complete the vaccine series during the study period.||participants|||Number
646519|NCT02145156|Primary|Number of Young Adults Who Initiated the HPV Vaccine Series During the Study Period|This outcome describes the number of young adult participants between the ages of 18-26 who had 0 doses of the HPV vaccine at study enrollment and received at least one dose during the study period.|16 months|Includes young adults in the sample who could be matched to vaccination data, who had not received all 3 doses of the HPV vaccine prior to baseline, and who also had 0 doses of the HPV vaccine prior to baseline.||participants|||Number
646520|NCT02145156|Primary|Number of Young Adults Who Received Any Dose of the HPV Vaccine During the Study Period|This outcome describes the number of young adult participants between the ages of 18-26 who received any dose of the HPV vaccine during the study period.|16 months|Includes young adults in the sample who could be matched to vaccination data and had not received all 3 doses of the HPV vaccine prior to baseline.||participants|||Number
646521|NCT02144337|Primary|Feasibility: Number of Participants With Adverse Events|Number of participants experiencing and/or reporting adverse events.|Participants were followed from baseline to research completion|||number of participants|||Number
646522|NCT02144337|Secondary|Change in Parental Hypoglycaemia Fear Using the Hypoglycaemia Fear Survey (HFS-Parent)||0 months (baseline) and 6 months (follow-up)||||||
646523|NCT02144337|Secondary|Change in Clinical Outcome Measures (Hba1c, Height, Weight)|Data collected as routine clinic procedure and will be used to assess changes in HbA1c and BMI from baseline to follow-up.|0 months (baseline) and 6 months (follow-up)||||||
646524|NCT02144337|Secondary|Change in Children's Level of Physical Activity (Measured Subjectively Via Self-report Questionnaire)||0 months (baseline) and 6 months (follow-up)||||||
646525|NCT02144337|Secondary|Change in Children's Self-efficacy Using CSAPPA Scale (Children's Self‐Perceptions of Adequacy in and Predilection for Physical Activity)||0 months (baseline) and 6 months (follow-up)||||||
646526|NCT02144337|Primary|Feasibility: Rate of Adherence to the Intervention|Attendance at physical activity sessions and completion of activity diary Intervention group only as the Control group were not exposed to any intervention.|Participants were monitored for the duration of the STAK programme (6 weeks)|||percentage of the intervention group|||Number
646527|NCT02144337|Primary|Feasibility: Response Rate|Number of participants completing outcome measures at T3|Response rate at T3|||Number of participants|||Number
646528|NCT02144337|Primary|Feasibility: Response Rate|Number of participants completing outcome measures at T2|Response rate at T2|||number of participants|||Number
646529|NCT02144259|Other Pre-specified|Contraceptive Satisfaction|"Satisfaction will be measured in response to the question, How satisfied are you with your current birth control method? This question will be asked to the participant at the 6 month follow-up visit. Answer choices that participants could choose from range from Very Good to Very Poor. Good or Very Good responses will be analyzed as having been satisfied with the method."|1 year|||percentage of women satisfied w. method|||Number
646530|NCT02144259|Secondary|Pregnancy Rate|The secondary outcome variable is pregnancy rate. Pregnancy testing will occur at 3, 6 and 12 months postpartum or at any time that a participant felt that she might be pregnant.|1 year|||number of pregnancies|||Number
646531|NCT02144259|Primary|Weight|Weight will be measured at 6 months postpartum. Percent weight change will be compared amongst the groups|6 months from postpartum (baseline)|||percent weight lost||Standard Deviation|Mean
646532|NCT02144220|Secondary|Percentage of Patients Who Felt That the Recommendations Improved Their Health||6 months|||percentage of participants|||Number
646533|NCT02144220|Secondary|Feasibility (Descriptive)|Percentage of physician visits where the physician was were satisfied or very satisfied with the virtual visit overall.|6 months|||percentage of visits|||Number
646534|NCT02144220|Secondary|Acceptability|- The percent of patients participated who stated that they are interested in receiving ongoing care for their PD via telemedicine. (Goal >80%)|6 months|||percentage of participants|||Number
646535|NCT02144220|Primary|Change in Quality of Life as Measured by the PDQ-39 Assessment Tool|The impact on Quality of life (QoL) as measured by the change in PDQ-39 score from baseline to 6 months. The PDQ-39 is a 39-item self-report questionnaire, which assesses Parkinson’s disease-specific health related quality over the last month. 5-point ordinal scoring system: 0 = never, 1 = occasionally, 2 = sometimes, 3 = often, 4 = always. Each dimension total score range from 0 (never have difficulty) to 100 (always have difficulty). Lower scores reflect better quality of life.|Baseline and 6 months|||units on a scale||95% Confidence Interval|Number
646536|NCT02144220|Primary|Feasibility|The percent of telemedicine visits completed as scheduled. (Goal >80%)|6 months|||percentage of visits|||Number
646537|NCT02144012|Secondary|Patient-Reported Outcomes: Number of Participants Who Completed the FACT-Taxane Questionnaire|The FACT - Taxane is a self-reported instrument which measures the HRQOL of participants receiving taxane containing chemotherapy. The FACT-Taxane consists of 16 items and was designed to assess the impact of taxane treatment-related symptoms from the participant’s perspective.|Days 1 and 8 of Cycles 1 and 2 and on the first day of each subsequent 21-day cycle thereafter as well as at study drug completion or discontinuation visit (up to 20 months)|The ITT population included all randomized participants grouped according to the treatment assigned at randomization.||Participants|||Count of Participants
650040|NCT02062801|Secondary|Tetanic (Sustained) Uterine Contraction (TUC)|Incidence of Tetanic (sustained) Uterine Contraction (TUC)|Within 30 minutes of combined spinal epidural (CSE) placement|||participants|||Number
646538|NCT02144012|Secondary|Patient-Reported Outcomes: Number of Participants Who Completed the Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) Questionnaire|The FACT-B (version 4) is a self-reported instrument which measures health-related quality of life (HRQOL) of participants with breast cancer.The FACT-B includes the breast cancer sub-scale (BCS) and is comprised of nine items specific to assessing patients’ HRQOL in breast cancer.|On the first Day of each 21-day Cycle (Day 1, 22, 43, etc.) and at study drug completion or discontinuation visit (up to 20 months)|The ITT population included all randomized participants grouped according to the treatment assigned at randomization.||Participants|||Count of Participants
646539|NCT02144012|Secondary|Immunogenicity: Percentage of Positive Anti-Therapeutic Antibody (ATA) Response to Trastuzumab Emtansine||Day 1, Cycle 1 (Day 1), Day 1, Cycle 4 (Day 64) and at study drug completion or discontinuation visit (up to 20 months)|The ITT population included all randomized participants grouped according to the treatment assigned at randomization. Only participants with at least one post-dose sample available for ATA analysis were analyzed for this outcome measure.||percentage of participants|||Number
646540|NCT02144012|Secondary|Pharmacokinetics: Serum Concentrations of Study Medications|Pharmacokinetic (PK) parameters were to be determined in a subset of participants. PK samples from the first 100 Chinese participants were planned to be collected.|Day 1, Cycle 1 (Day 1), Day 1, Cycle 2 (Day 22), Day 1, Cycle 4 (Day 64) and at study drug completion or discontinuation visit (up to 20 months)|No PK analyses were performed as no participants were enrolled from China and no samples were collected.|||||
646541|NCT02144012|Secondary|Duration of Response (DOR)|DOR was defined as the time from the date of initial confirmed PR or CR to the date of disease progression or death within the study. CR: disappearance of all target lesions; PR: >=30% decrease in the sum of the longest diameter of target lesions. Disease progression was defined according to RECIST, v1.1 as at least a 20% increase in the sum of diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions.|At time of clinical data cut-off (up to 20 months)|The ITT population included all randomized participants grouped according to the treatment assigned at randomization. Participants, for whom data were collected, are included in the analysis for this outcome measure.||months||95% Confidence Interval|Median
646542|NCT02144012|Secondary|Objective Response Rate (ORR)|ORR was defined as percentage of participants with partial response (PR) or complete response (CR) determined on the basis of investigator assessments with the use of RECIST v1.1. Tumor assessments were performed with computed tomography (CT) or magnetic resonance imaging (MRI) scans of the chest, abdomen, and pelvis. CR: disappearance of all target lesions; PR: >=30% decrease in the sum of the longest diameter of target lesions; Objective Response Rate (OR) = CR + PR.|At time of clinical data cut-off (up to 20 months)|The ITT population included all randomized participants grouped according to the treatment assigned at randomization. Participants, for whom data were collected, are included in the analysis for this outcome measure.||percentage of participants||95% Confidence Interval|Number
646543|NCT02144012|Secondary|OS Truncated at 2 Years|OS truncated at 2 years was defined as the time from the date of randomization to the date of death from any cause, with deaths occurring beyond 2 years after the participant's randomization date censored at 2 years.|At 24 months|Data for this outcome measure were not collected and are therefore not reported. The study was terminated before the time point for data collection of this outcome measure.|||||
646544|NCT02144012|Secondary|One-Year Survival Rate|One-year survival rate as determined by Kaplan-Meier estimates.|At 12 months|The ITT population included all randomized participants grouped according to the treatment assigned at randomization. Participants, for whom data were collected, are included in the analysis for this outcome measure.||percentage of participants||95% Confidence Interval|Median
646545|NCT02144012|Secondary|Overall Survival (OS)|OS was defined as the time from the date of randomization to the date of death from any cause.|At time of clinical data cut-off (up to 20 months)|The ITT population included all randomized participants grouped according to the treatment assigned at randomization.||months||95% Confidence Interval|Median
646546|NCT02144012|Primary|Safety: Percentage of Participants With Significant Decline in Left Ventricular Ejection Fraction (LVEF)|Significant decline in LVEF was defined as LVEF below 50% and decrease from baseline of 15% points or more. Echocardiogram or multiple-gated acquisition (MUGA) scan was used to assess LVEF.|At time of clinical data cut-off (up to 20 months)|The safety analysis population consisted of all participants who received at least one dose of study drug. Safety analyses were based on the treatment that participants actually received.||percentage of participants|||Number
646547|NCT02144012|Primary|Safety: Percentage of Participants With Adverse Events Leading to Dose Reduction||At time of clinical data cut-off (up to 20 months)|The safety analysis population consisted of all participants who received at least one dose of study drug. Safety analyses were based on the treatment that participants actually received.||percentage of participants|||Number
646548|NCT02144012|Primary|Safety: Percentage of Participants With Adverse Events Leading to Treatment Interruption||At time of clinical data cut-off (up to 20 months)|The safety analysis population consisted of all participants who received at least one dose of study drug. Safety analyses were based on the treatment that participants actually received.||percentage of participants|||Number
646549|NCT02144012|Primary|Percentage of Participants With Adverse Events Leading to Treatment Discontinuation||At time of clinical data cut-off (up to 20 months)|The safety analysis population consisted of all participants who received at least one dose of study drug. Safety analyses were based on the treatment that participants actually received.||percentage of participants|||Number
646550|NCT02144012|Primary|Safety: Percentage of Participants With Grade 3 and 4 AEs|Grade 3 and 4 AEs were evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0. Grade 3 was defined as severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living, including bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden. Grade 4 was defined as life-threatening consequences; urgent intervention indicated.|At time of clinical data cut-off (up to 20 months)|The safety analysis population consisted of all participants who received at least one dose of study drug. Safety analyses were based on the treatment that participants actually received.||percentage of participants|||Number
649767|NCT02071849|Secondary|Mean Gradient - Change From Baseline|Transthoracic echocardiography parameter|Baseline and 6 months|Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.||mm Hg||Standard Deviation|Mean
646551|NCT02144012|Primary|Safety: Percentage of Participants With Adverse Events (AEs)|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|At time of clinical data cut-off (up to 20 months)|The safety analysis population consisted of all participants who received at least one dose of study drug. Safety analyses were based on the treatment that participants actually received.||percentage of participants|||Number
646552|NCT02144012|Primary|Progression-Free Survival (PFS)|PFS was defined as the time from randomization to the first occurrence of disease progression or death from any cause, whichever occurred first, on the basis of investigator assessments. Progression was defined according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as at least a 20% increase in the sum of diameters of target lesions with an absolute increase of at least 5 millimeter (mm) or the appearance of one or more new lesions.|At time of clinical data cut-off (up to 20 months)|The intent-to-treat (ITT) population included all randomized participants grouped according to the treatment assigned at randomization.||months||95% Confidence Interval|Median
646553|NCT02143947|Secondary|Maximum First Ray Complex Plantarflexion During Stance|The first ray complex plantarflexion during the stance phase of walking with the subject wearing a sandal and their assigned orthotic (Full Contact or Maximal Arch Subtalar Stabilization) was recorded 5 weeks post receiving their assigned orthotic. The stance phase of walking was divided into 4 subphases (Phase 1: 0 to 17%, Phase 2: 18 to 50%, Phase 3: 51 to 83%, and Phase 3: 84 to 100% of stance) and the maximum first ray complex plantarflexion during each subphase determined.|Absolute values measured at 5 weeks|The number of participants used for the analysis was based upon the availability of complete data sets.||Degrees||Standard Deviation|Mean
646554|NCT02143947|Secondary|Maximum Forefoot Inversion During Stance|The forefoot inversion motion during the stance phase of walking with the subject wearing a sandal and their assigned orthotic (Full Contact or Maximal Arch Subtalar Stabilization) was recorded 5 weeks post receiving their assigned orthotic. The stance phase of walking was divided into 4 subphases (Phase 1: 0 to 17%, Phase 2: 18 to 50%, Phase 3: 51 to 83%, and Phase 3: 84 to 100% of stance) and the maximum forefoot inversion during each subphase determined.|Absolute values measured at 5 weeks|The number of participants used for the analysis was based upon the availability of complete data sets.||Degrees||Standard Deviation|Mean
646555|NCT02143947|Secondary|Maximum Electromyographic Activity of Lower Leg Muscles|The maximum electromyographic activity of the lower leg muscles is with respect to the barefoot condition. The electromyographic activity of the lower extremity muscles were recorded during the stance phase of walking while barefoot and while wearing their assigned orthotic (Full Contact or Maximal Arch Subtalar Stabilization). All electromyographic measurements were taken at the 5 week time point. The peak electromyographic activity during the stance phase of barefoot walking was determined. The electromyographic activity during the orthotic condition was amplitude normalized to the barefoot condition by dividing the electromyographic activity of the orthotic condition by the peak barefoot electromyographic activity and multiplying by 100. The stance phase of walking was then divided into 4 subphases (Phase 1: 0 to 17%, Phase 2: 18 to 50%, Phase 3: 51 to 83%, and Phase 3: 84 to 100% of stance) and the peak amplitude normalized electromyographic activity of each subphase det|Absolute values measured at 5 weeks|The number of participants used for the analysis was based upon the availability of complete data sets.||percentage of maximum electromyo actvity||Standard Deviation|Mean
646556|NCT02143947|Primary|Maximum Rearfoot Eversion Motion During Stance|The rearfoot eversion motion during the stance phase of walking with the subject wearing a sandal and their assigned orthotic (Full Contact or Maximal Arch Subtalar Stabilization) was recorded 5 weeks post receiving their assigned orthotic. The stance phase of walking was divided into 4 subphases (Phase 1: 0 to 17%, Phase 2: 18 to 50%, Phase 3: 51 to 83%, and Phase 3: 84 to 100% of stance) and the maximum rearfoot eversion during each subphase determined.|Absolute values measured at 5 weeks|The number of participants used for the analysis was based upon the availability of complete data sets.||Degrees||Standard Deviation|Mean
646557|NCT02143583|Secondary|Average of the Total Score of the Validated Mini Rhinoconjunctivitis Quality-of-life Questionnaire© (Mini RQLQ) Obtained Weekly During the Birch Pollen Season|"The Mini-RQLQ will be used. This evaluation tool includes 14 questions assessing 5 domains (activity limitation, practical problems, nose symptoms, eye symptoms, and non-nose/eye symptoms).
For each question the answer is quoted from 0: no troubled to 6: extremely troubled; then the average of the score for the 14 questions is calculated resulting in a scale from 0 to 6, 0 being the best case and 6 the worst case"|between the 42nd day after the start of the season and the last day in the last occurrence of 3 consecutive days with a regional pollen count ≥ 10 grains/m3|Modified-ITT analysis set : patients having received at least 4 injections of AllerT or placebo in AN004T||units on a scale||Standard Deviation|Mean
646558|NCT02143583|Primary|Average of the Combined Rhinoconjunctivitis Symptom and Medication Score (RSMS) Obtained Daily During the Birch Pollen Season|"The scale range is from 0 to 3. Lower is the the RSMS value, better is the efficacy as this implies that lower is the symptoms and concomitant medication intake by the patient The RSMS includes 2 subscales : the Rhinoconjunctivitis Symptom Score (RSS) with a range of values from 0 to 3 and the Rhinoconjunctivitis Medication Score Score (RMS) with also a range of values from 0 to 3 The RSMS is the sum of the RSS and RMS divided by 2 The Rhinoconjunctivitis Symptom Score (RSS) comprises 6 different symptoms from the nose and eyes. The sum of the 6 symptom scores divided by 6 will be used as the RSS (scale of 0 to 3).
The daily Rhinoconjunctivitis Medication Score (RMS) will be determined by assigning daily scores as follows:
0 = no medication
= subject took topical antihistamine
= subject took oral antihistamine
= subject took oral corticosteroids"|from the first of 3 consecutive days with a regional pollen count > 10 grains/m3 to the earliest between the 42nd day after the start of the season and the last day in the last occurrence of 3 consecutive days with a regional pollen count ≥ 10 grains/m3|Modified-ITT analysis set : participants having received at least 4 injections of AllerT or placebo in AN004T||units on a scale||Standard Deviation|Mean
646624|NCT02142361|Primary|Participant's Subjective Rating for Vision Quality End of the Day|Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week end of the day. Rated on a visual analog scale (VAS). (0-100, 0=extremely poor vision totally blurred, 100= excellent vision totally sharp)|Baseline and 1 week|||units on a scale||Standard Deviation|Mean
646560|NCT02143141|Secondary|Itching|The itching assessment is made using a Visual Analog Scale (VAS). VAS is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. Scale ranges from 0 indicating no itching to 100 indicating the most severe itching.|24 hours|||units on a scale||Standard Deviation|Mean
646561|NCT02143141|Primary|Pain|Pain assessment is made using a Visual Analog Scale (VAS). VAS is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. Scale ranges from 0 indicating no pain to 100 indicating the most severe pain.|24 hours|||units on a scale||Standard Deviation|Mean
646562|NCT02142738|Secondary|Objective Response Rate (ORR)|ORR was defined as the percentage of participants in the analysis population who experienced a Complete Response (CR; disappearance of all target lesions) or a Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions) and was assessed using RECIST 1.1 based on BICR evaluation. The ORR through the data cutoff date of 09 May 2016 is presented for each treatment group.|Through data cutoff data of 09 May 2016 (Up to approximately 1.6 years)|The ITT population included all randomized participants. Participants were included in the treatment group to which they were randomized, regardless of whether or not they received study treatment.||Percentage of Participants||95% Confidence Interval|Number
646563|NCT02142738|Secondary|Overall Survival (OS) Rate at Month 6|OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up. In those instances where participants were confirmed to be alive on the visit cut-off date of 09 May 2016, survival was censored as of 09 May 2016. The OS rate at Month 6 was calculated.|Month 6|The ITT population included all randomized participants. Participants were included in the treatment group to which they were randomized, regardless of whether or not they received study treatment.||Percentage of Participants||95% Confidence Interval|Number
646564|NCT02142738|Primary|Progression Free Survival (PFS) Rate at Month 6|PFS was defined as the time from randomization to documented disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) or death due to any cause, whichever occurred first and was based on blinded independent central radiologists’ (BICR) review. Progressive Disease (PD) was defined as ≥20% increase in the sum of diameters of target lesions and an absolute increase of ≥5 mm. (Note: the appearance of one or more new lesions was also considered progression). Participants were evaluated every 9 weeks with radiographic imaging to assess their response to treatment. The PFS rate at Month 6 was calculated.|Month 6|The Intention-to-treat (ITT) population included all randomized participants. Participants were included in the treatment group to which they were randomized, regardless of whether or not they received study treatment.||Percentage of Participants||95% Confidence Interval|Number
646565|NCT02142712|Other Pre-specified|CT or MRI of Head Without Contrast|MRI of head or CT head done as part of your follow up care at 3 months. This will give us the information about the effect of dextromethorphan effect on the final brain damage from stroke.|At 3 months from baseline|The data was not collected since the participants did not come back for follow-ups.|||||
646566|NCT02142712|Primary|Barthel Index|"It is an ordinal scale used to measure performance in activities of daily living (ADL). Each performance item is rated on this scale with a given number of points assigned to each level or ranking. It uses ten variables describing ADL and mobility. A higher number is associated with a greater likelihood of being able to live at home with a degree of independence following discharge from hospital. It yields a score of 0-20.
The ten variables addressed in the Barthel scale are:
presence or absence of fecal incontinence
presence or absence of urinary incontinence
help needed with grooming
help needed with toilet use
help needed with feeding
help needed with transfers (e.g. from chair to bed)
help needed with walking
help needed with dressing
help needed with climbing stairs
help needed with bathing"|At 3 months from baseline|The data was not collected since the participants did not come back for follow-ups.|||||
646567|NCT02142712|Primary|Glasgow Coma Scale (GCS)|Glasgow Coma Scale (GCS) is assessed by physical neurological examination of the subject by a qualified neurologist. GSC is a common scoring system used to describe the level of consciousness in a person following a traumatic brain injury. The initial score correlates with the severity of brain injury and prognosis. It estimates Coma severity based on Eye (4), Verbal (5), and Motor (6) criteria with the following total score of between 3 (indicating deep unconsciousness) and 15 (indicating no issues).|Baseline|Data was collected only for the baseline visit, since the participants did not come back for follow-ups.||Glasgow Coma Scale|||Number
646568|NCT02142712|Primary|National Institutes of Health Stroke Severity (NIHSS) Scale|NIHSS is a tool used by healthcare providers to objectively quantify the degree of impairment caused by a stroke. It is composed of 11 items. Each item scores a specific ability between a score of 0-4. Usually, for each item, a score of 0 indicates normal function in that specific ability, while a higher score indicates some level of impairment. The individual scores from each item are added together to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.|Baseline|NIHSS data was only collected for the baseline visit, since the participants did not come back for follow-ups.||NIHSS scale|||Number
646569|NCT02142712|Primary|Modified Rankin Score|"The modified Rankin Scale (m-RS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people after they have suffered a stroke.It is one of the most widely used clinical outcome measure for stroke clinical trials. The score is given according to following scale.
0- No symptoms at all
No significant disability despite symptoms; able to carry out all usual duties and activities
Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance
Moderate disability; requiring some help, but able to walk without assistance
Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance
Severe disability; bedridden, incontinent and requiring constant nursing care and attention
Dead"|8 days and 3 months from the baseline|The data was not collected since the participants did not come back for follow-ups.|||||
646570|NCT02142504|Secondary|Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)|Geometric mean fold rise (GMFR) of anti-norovirus GII.4 VLP antibody titers as measured by the HBGA binding assay.|Day 28|Participants from the Per Protocol Set, all participants in Full Analysis Set, who had evaluable blood samples at baseline, and Day 28 within the specified window (+/- 7 days), and did not have major protocol violations, with data available for this outcome measure.||ratio||Standard Deviation|Geometric Mean
646571|NCT02142504|Secondary|Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)|Geometric mean fold rise (GMFR) of anti-norovirus GI.1 VLP antibody titers as measured by HBGA binding assay.|Day 28|Per Protocol Set included all participants in Full Analysis Set, who had evaluable blood samples at baseline, and Day 28 within the specified window (+/- 7 days), and did not have major protocol violations.||ratio||Standard Deviation|Geometric Mean
646572|NCT02142504|Secondary|Blocking Titers 50 (BT50) of Anti-Norovirus GII.4 VLP Antibody Titers (HBGA)|Blocking titers 50 (BT50) of anti-norovirus GII.4 VLP antibody titers as measured by HBGA binding assay.|Day 28|Participants from the Per Protocol Set, all participants in Full Analysis Set, who had evaluable blood samples at baseline, and Day 28 within the specified window (+/- 7 days), and did not have major protocol violations, with data available for this outcome measure.||titer||Standard Deviation|Geometric Mean
646573|NCT02142504|Secondary|Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)|Blocking titers 50 (BT50) of anti-norovirus GI.1 VLP antibody titers as measured by HBGA binding assay.|Day 28|Per Protocol Set included all participants in Full Analysis Set, who had evaluable blood samples at baseline, and Day 28 within the specified window (+/- 7 days), and did not have major protocol violations.||titer||Standard Deviation|Geometric Mean
646574|NCT02142504|Secondary|Percentage of Participants With a Seroresponse in Serum GII.4 VLP Antibody Titers (HBGA)|Seroresponse is defined as 4-fold rise or greater in serum anti-norovirus antibody titers for GII.4 virus-Like particle (VLP) as measured by HBGA binding assay.|Baseline and Day 28|Participants from the Per Protocol Set, all participants in Full Analysis Set, who had evaluable blood samples at baseline, and Day 28 within the specified window (+/- 7 days), and did not have major protocol violations, with data for this outcome measure||percentage of participants||95% Confidence Interval|Number
646575|NCT02142504|Secondary|Percentage of Participants With a Seroresponse in Serum GI.1 VLP Antibody Titers (HBGA)|Seroresponse is defined as 4-fold rise or greater in serum anti-norovirus antibody titers for GI.1 virus-Like particle (VLP) as measured by HBGA binding assay.|Baseline and Day 28|Per Protocol Set included all participants in Full Analysis Set, who had evaluable blood samples at baseline, and Day 28 within the specified window (+/- 7 days), and did not have major protocol violations.||percentage of participants||95% Confidence Interval|Number
646576|NCT02142504|Secondary|Percentage of Participants With a Seroresponse in Both Serum Anti-norovirus GI.1 VLP and GII.4 VLP (HBGA)|Seroresponse is defined as 4-fold rise or greater in serum anti-norovirus antibody titers for both GI.1 virus-Like particle (VLP) and GII.4 VLP as measured by histoblood group antigen (HBGA) binding assay.|Baseline and Day 28|Participants from the Per Protocol Set, all participants in Full Analysis Set, who had evaluable blood samples at baseline, and Day 28 within the specified window (+/- 7 days), and did not have major protocol violations, with data available for this outcome measure.||percentage of participants||95% Confidence Interval|Number
646577|NCT02142504|Secondary|Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)|Geometric mean fold rise (GMFR) of anti-norovirus GII.4 VLP antibody titers as measured by Pan-Ig ELISA.|Day 28|Per Protocol Set included all participants in Full Analysis Set, who had evaluable blood samples at baseline, and Day 28 within the specified window (+/- 7 days), and did not have major protocol violations.||ratio||Standard Deviation|Geometric Mean
646578|NCT02142504|Secondary|Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)|Geometric mean fold rise (GMFR) of anti-norovirus GI.1 VLP antibody titers as measured by Pan-Ig ELISA.|Day 28|Per Protocol Set included all participants in Full Analysis Set, who had evaluable blood samples at baseline, and Day 28 within the specified window (+/- 7 days), and did not have major protocol violations.||ratio||Standard Deviation|Geometric Mean
646579|NCT02142504|Secondary|Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)|Geometric mean titer (GMT) of anti-norovirus GII.4 VLP antibody titers as measured by Pan-Ig ELISA.|Day 28|Per Protocol Set included all participants in Full Analysis Set, who had evaluable blood samples at baseline, and Day 28 within the specified window (+/- 7 days), and did not have major protocol violations.||titer||Standard Deviation|Geometric Mean
646580|NCT02142504|Secondary|Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)|Geometric mean titer (GMT) of anti-norovirus GI.1 VLP antibody titers as measured by Pan-Ig ELISA.|Day 28|Per Protocol Set included all participants in Full Analysis Set, who had evaluable blood samples at baseline, and Day 28 within the specified window (+/- 7 days), and did not have major protocol violations.||titer||Standard Deviation|Geometric Mean
646581|NCT02142504|Secondary|Percentage of Participants With a Seroresponse in Serum Anti-norovirus GII.4 VLP (Pan-Ig ELISA)|Seroresponse is defined as 4-fold rise or greater in serum anti-norovirus antibody titers for GII.4 virus-like particles (VLP) as measured by pan immunoglobulin (Pan-Ig) enzyme-linked immunosorbent assay (ELISA).|Baseline and Day 28|Per Protocol Set included all participants in Full Analysis Set, who had evaluable blood samples at baseline, and Day 28 within the specified window (+/- 7 days), and did not have major protocol violations.||percentage of participants||95% Confidence Interval|Number
646582|NCT02142504|Secondary|Percentage of Participants With a Seroresponse in Serum Anti-norovirus GI.1 VLP (Pan-Ig ELISA)|Seroresponse is defined as 4-fold rise or greater in serum anti-norovirus antibody titers for GI.1 virus-Like particle (VLP) as measured by pan immunoglobulin (Pan-Ig) enzyme-linked immunosorbent assay (ELISA).|Baseline and Day 28|Per Protocol Set included all participants in Full Analysis Set, who had evaluable blood samples at baseline, and Day 28 within the specified window (+/- 7 days), and did not have major protocol violations.||percentage of participants||95% Confidence Interval|Number
646583|NCT02142504|Secondary|Percentage of Participants With a Seroresponse in Both Serum Anti-norovirus GI.1 VLP and GII.4 VLP (Pan-Ig ELISA)|Seroresponse is defined as 4-fold rise or greater in serum anti-norovirus antibody titers for both GI.1 virus-Like particle (VLP) and GII.4 VLP as measured by pan immunoglobulin (Pan-Ig) enzyme-linked immunosorbent assay (ELISA).|Baseline and Day 28|Per Protocol Set included all participants in Full Analysis Set, who had evaluable blood samples at baseline, and Day 28 within the specified window (+/- 7 days), and did not have major protocol violations.||percentage of participants||95% Confidence Interval|Number
646584|NCT02142504|Secondary|Percentage of Participants With Unsolicited Adverse Events (AEs) After the Second Injection|Unsolicited AEs are any AEs that are not solicited local or systemic AEs, as defined by this study.|Days 365 through 393|Participants from the Safety Analysis Set who received a second injection.||percentage of participants|||Number
650041|NCT02062801|Primary|Early Profound Fetal Bradycardia|Incidence of early profound fetal bradycardia|Within 30 minutes of combined spinal epidural (CSE) placement|||participants|||Number
646585|NCT02142504|Secondary|Percentage of Participants With Elevated Daily Oral Temperature (Fever) After the Second Injection|Fever is defined as greater than or equal to 38°C (100.4°F). Oral body temperature measurement was performed using the thermometer provided by the site for 7 days after each vaccination. The highest body temperature observed each day was recorded on the Diary Card also provided by the site.|Days 365 through 371|Participants from the Safety Analysis Set who received a second injection.||percentage of participants|||Number
646586|NCT02142504|Secondary|Percentage of Participants With Solicited Systemic Adverse Events (AEs) After the Second Injection|Solicited systemic AEs are defined as: headache, fatigue, myalgia, arthralgia, vomiting, and diarrhea that occurred within 7 days after the vaccination on Day 365.|Days 365 through 371|Participants from the Safety Analysis Set who received a second injection.||percentage of participants|||Number
646587|NCT02142504|Secondary|Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After the Second Injection|Solicited local AEs at injection site are defined as: pain, erythema, induration, and swelling that occurred within 7 days after the vaccination on Day 365.|Days 365 through 371|Participants from the Safety Analysis Set who received a second injection.||percentage of participants|||Number
646588|NCT02142504|Primary|Percentage of Participants With Any Adverse Event (AE) Leading to Withdrawal From the Study|Withdrawal due to an AE occurred if the participant experienced an AE that required early termination because continued participation imposed an unacceptable risk to the participant's health or the participant was unwilling to continue because of the AE.|Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)|Safety Analysis Set included all participants who received at least one dose of trial vaccination.||percentage of participants|||Number
646589|NCT02142504|Primary|Percentage of Participants With Adverse Events of Special Interest (AESI) After the Second Injection|AESIs are AEs that are not solicited local or systemic AEs, they are predefined AEs that required close monitoring and prompt reporting to the sponsor. AESI included protocol specified Cardiac Disorders, Gastrointestinal Disorders, Immune System Disorders, Infections and Infestations, Musculoskeletal and Connective Tissue Diseases, Neuroinflammatory Disorders, Renal and Urinary Disorders, Skin Disorders, Thyroid Disorders, Vascular Disorders and Other Disorders.|From second injection (Day 365) to 6 months after second injection (Up to Day 545)|Participants from the Safety Analysis Set who received a second injection.||percentage of participants|||Number
646590|NCT02142504|Primary|Percentage of Participants With Adverse Events of Special Interest (AESI) After the First Injection|AESIs are AEs that are not solicited local or systemic AEs, they are predefined AEs that required close monitoring and prompt reporting to the sponsor. AESI included protocol specified Cardiac Disorders, Gastrointestinal Disorders, Immune System Disorders, Infections and Infestations, Musculoskeletal and Connective Tissue Diseases, Neuroinflammatory Disorders, Renal and Urinary Disorders, Skin Disorders, Thyroid Disorders, Vascular Disorders and Other Disorders.|From first injection (Day 1) to second injection pre-dose (Up to Day 365)|Safety Analysis Set included all participants who received at least one dose of trial vaccination.||percentage of participants|||Number
646591|NCT02142504|Primary|Percentage of Participants With Serious Adverse Events (SAEs) After the Second Injection|A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.|From second injection (Day 365) to 6 months after second injection (Up to Day 545)|Participants from the Safety Analysis Set who received a second injection.||percentage of participants|||Number
646592|NCT02142504|Primary|Percentage of Participants With Serious Adverse Events (SAEs) After the First Injection|A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.|From first injection (Day 1) to second injection pre-dose (Up to Day 365)|Safety Analysis Set included all participants who received at least one dose of trial vaccination.||percentage of participants|||Number
646593|NCT02142504|Primary|Percentage of Participants With Unsolicited Adverse Events (AEs) After the First Injection|Unsolicited AEs are any AEs that are not solicited local or systemic AEs, as defined by this study.|Days 1 through 28|Safety Analysis Set included all participants who received at least one dose of trial vaccination.||percentage of participants|||Number
646594|NCT02142504|Primary|Percentage of Participants With Elevated Daily Oral Temperature (Fever) After the First Injection|Fever is defined as greater than or equal to 38°C (100.4°F). Oral body temperature measurement was performed using the thermometer provided by the site for 7 days after each injection. The highest body temperature observed each day was recorded on the Diary Card also provided by the site.|Days 1 through 7|Safety Analysis Set included all participants who received at least one dose of trial vaccination.||percentage of participants|||Number
646595|NCT02142504|Primary|Percentage of Participants With Solicited Systemic Adverse Events (AEs) After the First Injection|Solicited systemic AEs are defined as: headache, fatigue, myalgia, arthralgia, vomiting, and diarrhea that occurred within 7 days after the primary injection.|Days 1 through 7|Safety Analysis Set included all participants who received at least one dose of trial vaccination.||percentage of participants|||Number
646596|NCT02142504|Primary|Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After the First Injection|Solicited local AEs at injection site are defined as: pain, erythema, induration, and swelling that occurred within 7 days after the primary injection.|Days 1 through 7|Safety Analysis Set included all participants who received at least one dose of trial vaccination.||percentage of participants|||Number
646597|NCT02142361|Primary|Participant's Subjective Rating for Overall Satisfaction - Comfort|Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."||percentage of eyes|Participants||Number
650822|NCT02043379|Secondary|Hospital Discharge|From admit post-operative to the Pediatric cardiac intensive care unit until discharge from the hospital in days.|Approximately 1 month|||days||Inter-Quartile Range|Median
646598|NCT02142361|Primary|Clinician's Assessment Rotational Recovery in Degrees After 60 Seconds-Left Eye|Assessed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week . Slit lamp, with 10x magnification. Lens ability to return to its original position measured 60 seconds after manually rotating the lens 45 degrees temporally.|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."||degrees|Participants|Standard Deviation|Mean
646599|NCT02142361|Primary|Clinician's Assessment Rotational Recovery in Degrees After 60 Seconds-Right Eye|Assessed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week . Slit lamp, with 10x magnification. Lens ability to return to its original position measured 60 seconds after manually rotating the lens 45 degrees temporally.|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."||degrees|Participants|Standard Deviation|Mean
646600|NCT02142361|Primary|Clinician's Assessment Lens Orientation in Primary Position of Gaze-Left Eye|Assessed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week . Slit lamp, with 10x magnification. Nasal mislocation is recorded as (+) and temporal as (-). Mislocation of the axis mark on the lens relative to the 6 o'clock position, zero rotation, measured in degrees.|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."||percentage of eyes|Participants||Number
646601|NCT02142361|Primary|Clinician's Assessment Lens Orientation in Primary Position of Gaze- Right Eye|Assessed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week . Slit lamp, with 10x magnification. Nasal mislocation is recorded as (+) and temporal as (-). Mislocation of the axis mark on the lens relative to the 6 o'clock position, zero rotation, measured in degrees.|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."||percentage of eyes|Participants||Number
646602|NCT02142361|Primary|Clinician's Assessment Post-Blink Movement-Left Eye|Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Assessed immediately after the blink. (0-4, 0=insufficient, unacceptable movement, 1=minimal, but acceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."||percentage of eyes|Participants||Number
646603|NCT02142361|Primary|Clinician's Assessment Post-Blink Movement- Right Eye|Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Assessed immediately after the blink. (0-4, 0=insufficient, unacceptable movement, 1=minimal, but acceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."||percentage of eyes|Participants||Number
646604|NCT02142361|Primary|Clinicians Assessment Corneal Coverage-Left Eye|Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Assessed in primary gaze. (Y=yes, full corneal coverage at all times, N=no incomplete corneal coverage)|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."||percentage of eyes|Participants||Number
646605|NCT02142361|Primary|Clinician's Assessment Corneal Coverage-Right Eye|Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Assessed in primary gaze. (Y=yes, full corneal coverage at all times, N=no, incomplete corneal coverage)|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."||percentage of eyes|Participants||Number
646606|NCT02142361|Primary|Clinician's Assessment Lens Centration- Left Eye|Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Lens centration recorded by degree and direction in the primary positions. (0-2, 0=centered/optimal, 1=decentered slightlty, 2=substantially decentered (>0.5mm)|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."||percentage of eyes|Participants||Number
646607|NCT02142361|Primary|Clinician's Assessment Lens Centration-Right Eye|Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week . Lens centration recorded by degree and direction in the primary position. (0-2, 0=centered/optimal, 1=decentered slightly, 2=substantially decentered (>0.5mm))|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."||percentage of eyes|Participants||Number
646608|NCT02142361|Primary|Clinician's Assessment Overall Fit Acceptance- Left Eye|Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Overall fit acceptance based on lens fit alone (not comfort or vision). Likert scale. (0-4, 0=Very poor 1=Poor 2=Moderate, 3=Good, 4= Excellent)|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."||percentage of eyes|Participants||Number
646609|NCT02142361|Primary|Clinician's Assessment Overall Fit Acceptance- Right Eye|Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Overall fit acceptance based on lens fit alone (not comfort or vision). Likert scale. (0-4, 0=Very poor 1=Poor 2=Moderate, 3=Good, 4= Excellent)|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."||percentage of eyes|Participants||Number
646625|NCT02142361|Primary|Participant's Subjective Rating for Vision Quality During the Day|Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week . Rated on a visual analog scale (VAS). (0-100, 0=extremely poor vision totally blurred, 100= excellent vision totally sharp)|Baseline and 1 week|||units on a scale||Standard Deviation|Mean
646610|NCT02142361|Primary|Clinician's Assessment Overall Lens Stability-Left Eye|Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Overall performance of the lens in terms of axis stability on primary gaze, during lateral gaze, rotational recovery, and mislocation of the lens on blinking. Likert scale. (0-4, 0=very poor,1=poor, 2=moderate, 3=good, 4= excellent)|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."||percentage of eyes|Participants||Number
646611|NCT02142361|Primary|Clinician's Assessment Overall Lens Stability-Right Eye|Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Overall performance of the lens in terms of axis stability on primary gaze, during lateral gaze, rotational recovery, and mislocation of the lens on blinking. Likert scale. (0-4, 0=very poor,1=poor, 2=moderate, 3=good, 4= excellent)|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."||percentage of eyes|Participants||Number
646612|NCT02142361|Primary|Clinician's Objective Assessment Binocular High Contrast Distance Visual Acuity|Assessed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. LogMAR - Positive values denote poorer vision, negative values denote better vision than baseline 20/20 value|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."||LogMAR||Standard Deviation|Mean
646613|NCT02142361|Primary|Clinician's Objective Assessment Monocular High Contrast Distance Visual|Assessed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. LogMAR - Positive values denote poorer vision, negative values denote better vision than baseline 20/20 value.|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."||LogMAR||Standard Deviation|Mean
646614|NCT02142361|Primary|Participant's Subjective Rating for Overall Satisfaction - Overall|Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."||percentage of eyes|Participants||Number
646615|NCT02142361|Primary|Participant's Subjective Rating for Overall Satisfaction - Lens Fit|Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."||percentage of eyes|Participants||Number
646616|NCT02142361|Primary|Participant's Subjective Rating for Overall Satisfaction - Vision|Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week . Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."||percentage of eyes|Participants||Number
646617|NCT02142361|Primary|Participant's Subjective Rating for Overall Satisfaction - Handling|Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week . Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm.
Sum of percentage for the Study Lens Arm=101 as, Category title-  Somewhat dissatisfied- 1.7 was rounded to 2."||percentage of eyes|Participants||Number
646618|NCT02142361|Primary|Participant's Subjective Rating for Overall Satisfaction - Dryness|Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week . Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."||percentage of eyes|Participants||Number
646619|NCT02142361|Primary|Participant's Subjective Rating for Lens Pair Preference|Participants subjective preference in relation to comfort, dryness, handling, vision, lens fit and overall of the patient after wearing the study and their habitual lenses.|1 week|"All 60 paticipants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm. Vision category data for one participant was not collected."||Percentage of eyes|Participants||Number
646620|NCT02142361|Primary|Participant's Subjective Rating for Vision Stability at End of Day|Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-100, 0=Totally unstable Fluctuating/changing, 100= perfectly stable Not fluctuating/changing)|Baseline and 1 week|||units on a scale||Standard Deviation|Mean
646621|NCT02142361|Primary|Participant's Subjective Rating for Vision Stability During the Day|Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-100, 0=Totally unstable Fluctuating/changing, 100= perfectly stable Not fluctuating/changing)|Baseline and 1 week|||units on a scale||Standard Deviation|Mean
646622|NCT02142361|Primary|Participant's Subjective Rating for Vision Stability at Insertion|Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Rated on a visual analog scale (VAS). (0-100, 0=Totally unstable Fluctuating/changing, 100= perfectly stable Not fluctuating/changing)|Baseline and 1 week|||units on a scale||Standard Deviation|Mean
646623|NCT02142361|Primary|Participant's Subjective Rating for Night Vision Quality|Surveyed for each lens pair. Habitual pair at baseline. Study pair dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-100, 0=extremely poor vision totally blurred, 100= excellent vision totally sharp)|Baseline and 1 week|||units on a scale||Standard Deviation|Mean
649768|NCT02071849|Secondary|Peak Gradient - Change From Baseline|Transthoracic echocardiography parameter|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.||mm Hg||Standard Deviation|Mean
646626|NCT02142361|Primary|Participant's Subjective Rating for Vision Quality at Insertion|Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week .Rated on a visual analog scale (VAS). (0-100, 0=extremely poor vision totally blurred, 100= excellent vision totally sharp)|Baseline and 1 week|||units on a scale||Standard Deviation|Mean
646627|NCT02142361|Primary|Participant's Subjective Rating for Overall Vision Satisfaction|Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=completely dissatisfied, 10= very satisfied)|Baseline and 1 week|||units on a scale||Standard Deviation|Mean
646628|NCT02142361|Primary|Participant's Subjective Rating for Overall Lens Fit Stability|Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=very unstable / excessive movement, 10= very stable / good movement)|Baseline and 1 week|||units on a scale||Standard Deviation|Mean
646629|NCT02142361|Primary|Participant's Subjective Rating for Lens Handling - Insertion|Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=poor, 10= very easy)|Baseline and 1 week|||units on a scale||Standard Deviation|Mean
646630|NCT02142361|Primary|Participant's Subjective Rating for Overall Dryness|Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week . Rated on a visual analog scale (VAS). (0-10, 0=very dry, 10= no dryness)|Baseline and 1 week|||units on a scale||Standard Deviation|Mean
646631|NCT02142361|Primary|Participant's Subjective Rating for Dryness Prior to Removal|Surveyed prior to removal of each lens pair. Habitual pair at baseline . Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=very dry, 10= no dryness)|Baseline and 1 week|||units on a scale||Standard Deviation|Mean
646632|NCT02142361|Primary|Participant's Subjective Rating for Dryness During the Day|Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=very dry, 10= no dryness)|Baseline and 1 week|||units on a scale||Standard Deviation|Mean
646633|NCT02142361|Primary|Participant's Subjective Rating for Overall Lens Comfort|Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=poor, 10= can't feel)|Baseline and 1 week|||units on a scale||Standard Deviation|Mean
646634|NCT02142361|Primary|Participant's Subjective Rating for Lens Comfort Prior to Removal|Surveyed prior to removal of each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=poor, 10= can't feel)|Baseline and 1 week|||units on a scale||Standard Deviation|Mean
646635|NCT02142361|Primary|Participant's Subjective Rating for Lens Initial Comfort|Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=poor, 10= can't feel)|Baseline and 1 week|||units on a scale||Standard Deviation|Mean
646636|NCT02142153|Other Pre-specified|Pharmacokinetics|Blood samples (6 mL) for analysis of F901318 plasma concentration will be drawn pre-dose and at 1h, 2h, 3h and 4h and then 4.25, 4.5, 5.0, 5.5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 hours following the start of the infusion. (20 samples).|Single dose||||||
646637|NCT02142153|Secondary|Number of Subjects With Significant Clinical Safety Labs and ECG Abnormalities|Number of subjects with significant Clinical safety labs and ECG abnormalities as judged by the investigator from screening until final study visit|Single dose|||participants|||Number
646638|NCT02142153|Primary|Number of Subjects With Adverse Events|Adverse events will be collected from the time of screening until the final study visit|Single dose|Full analytical set||participants|||Number
646639|NCT02141997|Secondary|Percentage of Participants Achieving CR Based on Clinical Disease Activity Index (CDAI) at Week 12|The clinical disease activity index (CDAI) is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. CR is defined as a CDAI score ≤ 2.8 at Week 12. LOCF was used (only post-baseline values were carried forward).|Week 12|Participants in the FAS population with a baseline value and at least 1 post-baseline value||percentage of participants|||Number
646640|NCT02141997|Secondary|Percentage of Participants Achieving LDA or CR Based on Clinical Disease Activity Index (CDAI) at Week 12|The clinical disease activity index (CDAI) is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA is defined as a CDAI score from 2.8 to ≤ 10 at Week 12. CR is defined as a CDAI score ≤ 2.8 at Week 12. LOCF was used (only post-baseline values were carried forward).|Week 12|Participants in the FAS population with a baseline value and at least 1 post-baseline value||percentage of participants|||Number
646641|NCT02141997|Secondary|Percentage of Participants Achieving CR Based on DAS28 (hsCRP) at Week 12|The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10: a score >5.1 indicates high disease activity, a score <3.2 indicates low disease activity, and a score <2.6 indicates clinical remission. CR is defined as a DAS28 (hsCRP) score < 2.6 at Week 12. LOCF was used (only post-baseline values were carried forward).|Week 12|Participants in the FAS population with a baseline value and at least 1 post-baseline value||percentage of participants|||Number
646642|NCT02141997|Secondary|Percentage of Participants Achieving Low Disease Activity (LDA) or Clinical Remission (CR) Based on DAS28 (hsCRP) at Week 12|The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10: a score >5.1 indicates high disease activity, a score <3.2 indicates low disease activity, and a score <2.6 indicates clinical remission. LDA is defined as a DAS28 (hsCRP) score from 2.6 to < 3.2 at Week 12. CR is defined as a DAS28 (hsCRP) score < 2.6 at Week 12. LOCF was used (only post-baseline values were carried forward).|Week 12|Participants in the FAS population with a baseline value and at least 1 post-baseline value||percentage of participants|||Number
649769|NCT02071849|Secondary|Peak Gradient - Change From Baseline|Transthoracic echocardiography parameter|Baseline and 6 months|Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.||mm Hg||Standard Deviation|Mean
646643|NCT02141997|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 12|Response defined as at least 70% reduction (improvement) compared with baseline in tender joint count (TJC68), swollen joint count (SJC66), and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. LOCF was used (only post-baseline values were carried forward).|Baseline (Day 1) and Week 12|Participants in the FAS population with a baseline value and at least 1 post-baseline value||percentage of participants|||Number
646644|NCT02141997|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 12|Response defined as at least 50% reduction (improvement) compared with baseline in tender joint count (TJC68), swollen joint count (SJC66), and at least 3 of the 5 remaining ACR core set measures: patient’s assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. LOCF was used (only post-baseline values were carried forward).|Baseline (Day 1) and Week 12|Participants in the FAS population with a baseline value and at least 1 post-baseline value||percentage of participants|||Number
646645|NCT02141997|Secondary|Change in Disease Activity Score 28 With High Sensitivity C-Reactive Protein (DAS28 [hsCRP])|The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10: a score >5.1 indicates high disease activity, a score <3.2 indicates low disease activity, and a score <2.6 indicates clinical remission. A negative change from baseline represents improvement. n=the number of participants with evaluable data at each time point. LOCF was used (only post-baseline values were carried forward).|Baseline, Weeks 2, 4, 6, 8, and 12|Subjects in the FAS with a baseline value and at least 1 post-baseline value||units on a scale||95% Confidence Interval|Least Squares Mean
646646|NCT02141997|Primary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12|Response defined as at least 20% reduction (improvement) compared with baseline in tender joint count (TJC68), swollen joint count (SJC66), and at least 3 of the 5 remaining ACR core set measures: patient’s assessment of pain, patient's global assessment of disease activity (PtGA); physician's global assessment of disease activity (PGA), Health Assessment Questionnaire – Disability Index (HAQ-DI), and high-sensitivity C-reactive protein (hsCRP). Last observation carried forward (LOCF) was used for missing data (only post-baseline values were carried forward).|Baseline (Day 1) and Week 12|Full analysis set (FAS) defined as all randomized participants with at least 1 dose of study drug.||percentage of participants|||Number
646647|NCT02141984|Secondary|Parent’s Global Assessment for Effectiveness|Parent’s global assessment for effectiveness was evaluated as 'Improved,' 'Not changed,' 'Aggravated,' or 'Not assessable.'|From the first administration (Day 1) to approximately 12 weeks (±4 weeks)|Effectiveness analysis set: All participants who have been administered Humira for not less than 12 (± 4) weeks or more and for whom effectiveness evaluation parameters have been recorded including active joint count as well as Physician global assessment and Parent's global assessment at baseline and 12 weeks.||Participants|||Count of Participants
646648|NCT02141984|Secondary|Physician's Global Assessment of the Disease|The Physician's global assessment of the disease assessment was evaluated as 'Improved,' 'Not changed,' 'Aggravated,' or 'Not assessable.'|From the first administration (Day 1) to approximately 12 weeks (±4 weeks)|Effectiveness analysis set: All participants who have been administered Humira for not less than 12 (± 4) weeks or more and for whom effectiveness evaluation parameters have been recorded including active joint count as well as Physician global assessment and Parent's global assessment at baseline and 12 weeks.||participants|||Number
646649|NCT02141984|Secondary|Changes in Active Joint Count From Baseline and 12 Weeks Post-Treatment|Active Joint Count will be assessed and collected by participating investigators in routine medical practice. Sixty-eight joints were assessed by physical examination. Active joints are defined as joints with positive results for tenderness, swelling, pain on passive motion, or limitation of passive motion. Higher scores represent higher disease activity.|From the first administration (Day 1) to approximately 12 weeks (±4 weeks)|Effectiveness analysis set: All participants who have been administered Humira for not less than 12 (± 4) weeks or more and for whom effectiveness evaluation parameters have been recorded including active joint count as well as Physician global assessment and Parent's global assessment at baseline and 12 weeks.||active joint||Standard Deviation|Mean
646650|NCT02141984|Primary|Number of Participants With Adverse Events|An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either related, possible, probably not, not related, or unassessable. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above.|Adverse Events (AEs) were collected from informed consent to within 70 days following the last scheduled administration of Humira (up to 22 weeks)|Safety analysis set: All participants who received at least one administration of Humira during the study (after informed consent or first administration of Humira) and for 70 days following the last scheduled administration of Humira.||participants|||Number
646651|NCT02141867|Secondary|Duration of Critical Care Stay||Upto 30 days|||Days||Inter-Quartile Range|Median
646652|NCT02141867|Secondary|Admission to Critical Care After Surgery||Upto 30 days|||participants|||Number
646653|NCT02141867|Secondary|Duration of Hospital Stay||Upto 30 days|||Days||Inter-Quartile Range|Median
646654|NCT02141867|Primary|Mortality|In hospital mortality|Upto 30 days|||participants|||Number
646675|NCT02141620|Secondary|"Peak Ratings of Rush on the Visual Analog Scale"|"Subjects rated their feelings of Rush on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
649917|NCT02066051|Secondary|Number of Participants Who Experienced Adverse Events|Participants were screened for any sign of adverse events at each visit by the principal investigator or one of her colleagues.|12 months|||participants|||Number
646655|NCT02141854|Secondary|Patients With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period|An adverse event was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 to Week 12 of the Treatment Period|Safety population||Participants|||Count of Participants
646656|NCT02141854|Secondary|Kaplan-Meier Estimates for Time to 15% and 12% Improvement From Baseline in FEV1 Postdose on Day 1|"The baseline forced expiratory volume in 1 second (FEV1) was the average of the 2 predose FEV1 measurements (30 and 10 minutes predose) on Day 1. If one of these was missing, the other measurement was used as baseline value. If both were missing, the baseline trough FEV1 was treated as missing.
Time to target improvement (15% or 12%) was defined as the time elapsed from the time of first dose to the first time the target improvement in FEV1 was achieved. If an exact target increase was not achieved at a measured timepoint, then the time was estimated by linear interpolation between the timepoint when target was reached and the timepoint immediately before. Patients who did not achieve the target improvement were censored at the time of last serial spirometry assessment.
Values of NA indicate the values could not be estimated which happened when the estimated probability of not achieving target is more than 50%."|Day 1 of the Treatment Period (predose and postdose)|Patients who did not achieve the target improvement were censored at the time of last serial spirometry assessment.||hours||95% Confidence Interval|Median
646657|NCT02141854|Secondary|Change From Baseline in the Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ(S)) Score at Endpoint for Patients >=18 Years Old|"The AQLQ(S) (September 2010 version; patients aged ≥18 years) was self administered by the patients at the investigational center at the randomization visit and at Week 12 or end of trial. The questionnaire is a tool to measure the impact of asthma on a patient’s quality of life (physical, emotional, social, and occupational) with a recall period of 2 weeks. The AQLQ(S) was administered only to patients 18 years and older. The 32 individual questions in the AQLQ were equally weighted. The overall AQLQ score was the mean of the responses to each of the 32 questions, and ranged from 1 to 7. A score 7.0 indicated that the patient had no impairments due to asthma and a score of 1.0 indicated severe impairment.
Positive change from baseline scores indicate improved quality of life."|Day 1 (predose, baseline), end of trial (up to week 12)|Full analysis set of participants who contributed at least once to analysis and were >= 18 years old||units on a scale||Standard Error|Least Squares Mean
646658|NCT02141854|Secondary|Kaplan-Meier Estimate of Probability of Remaining in Study At Week 12|The analysis of probability of remaining in the study at Week 12 used the time to patient withdrawal for worsening asthma, defined as the number of days elapsed from the date of randomization to the date of withdrawal due to worsening asthma. Patients who were lost to follow-up, who had not withdrawn due to worsening asthma by week 12, or who had withdrawn due to reasons other than worsening asthma were right-censored at the date of last assessment.|up to Week 12 of the Treatment Period|Full analysis set||probability||95% Confidence Interval|Number
646659|NCT02141854|Secondary|Change From Baseline in the Weekly Average of the Total Daily (24-hour) Use of Albuterol/Salbutamol Inhalation Aerosol Over the 12-Week Treatment Period|"Patients recorded the number of inhalations of rescue medication (albuterol/salbutamol HFA MDI) each AM and PM in the diary. The average number of daily inhalations over the 7 days before the randomization visit was the baseline value. The weekly average was based on the available data for the 7 days before each analysis week.
The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using a mixed model for repeated measures."|Days -6 to Day 1 (predose, baseline), up to week 12|Full analysis set||puffs||Standard Error|Least Squares Mean
646660|NCT02141854|Secondary|Change From Baseline in the Weekly Average of the Total Daily Asthma Symptom Score Over the 12-Week Treatment Period|"The total daily asthma symptom score is the average of the daytime and nighttime scores as recorded in the patient diary.
Daytime Symptom Score:
0=No symptoms
1=Symptoms for 1 short period
2=Symptoms for 2+ short periods
3=Symptoms for most of the day - did not affect normal daily activities
4=Symptoms for most of the day - did affect normal daily activities
5=Symptoms so severe that I could not go to work or perform normal daily activities
Nighttime Symptom Score (determined in the AM):
0=No symptoms
1=Symptoms causing me to wake once (or wake early)
2=Symptoms causing me to wake twice or more (including waking early)
3=Symptoms causing me to be awake for most of the night
4=Symptoms so severe that I did not sleep Baseline was the average of recorded scores over the 7 days before randomization. The change from baseline in the weekly average over weeks 1 to 12 was analyzed using an mixed model for repeated measures (MMRM)."|Days -6 to Day 1 (predose, baseline), to Week 12|Full analysis set||units on a scale||Standard Error|Least Squares Mean
646661|NCT02141854|Secondary|Change From Baseline in the Weekly Average of the Daily Morning Trough Peak Expiratory Flow (PEF) Over the 12 Week Treatment|"Morning PEF tests were performed before administration of study drug or rescue medications (data were excluded if the time of PEF measurement was more than 5 minutes after the dose time). The patient recorded the highest value of 3 measurements obtained in the patient diary.
The baseline PEF was the average value of recorded (nonmissing) morning assessments over the 7 days prior to randomization on Day 1. For efficacy analyses of weekly average morning PEF measurements, values were the averages based on available data for that week."|Days -6 to Day 1 (predose, baseline), Day 1 (postdose) daily until Week 12|Full analysis set||liters/minute||Standard Error|Least Squares Mean
646662|NCT02141854|Primary|Change From Baseline in Morning Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12|Trough FEV1 is a morning spirometry taken predose and pre-rescue bronchodilator. The baseline for predose FEV1 was defined as the average of the 30-minute and 10-minute predose measurements obtained at the randomization visit (Day 1).|Day 1 (predose, baseline), Week 12|If the patient inadvertently administered asthma medication/study drug at home on the AM of the visit, or if the patient took rescue medication within 6 hours of testing, the visit was rescheduled.||liters||Standard Error|Least Squares Mean
649987|NCT02063880|Secondary|Number of Participants With Evidence of Immune Reconstitution and Inflammatory Syndrome (IRIS)|Confirmed, possible or likely IRIS based on external independent review|6 months post-HAART initiation|||participants|||Number
646663|NCT02141854|Primary|Standardized Baseline-Adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Effect Curve From Time Zero to 12 Hours PostDose (FEV1 AUEC0-12) at Week 12|A subset of patients performed postdose serial spirometry. Data from these assessments were used to analyze the primary endpoint of baseline-adjusted FEV1 AUEC0-12h at week 12 using the trapezoidal rule based on actual time of measurement. It was standardized by dividing it by the number of hours between the start time of dose administration and the end time of the last nonmissing FEV1 measurement. The baseline FEV1 was the average of the 2 predose FEV1 measurements (30 and 10 minutes predose). If 1 of these was missing, the nonmissing value was used; if both were missing, baseline was treated as missing. Baseline-adjusted FEV1 was calculated as postdose FEV1 after subtracting the baseline FEV1 value.|Day 1 (predose, baseline), Week 12 and was performed at the following times relative to the administration of study drug (±5 minutes): 15 and 30 minutes and 1, 2, 3, 4, 6, 8, 10, and 12 hours|A subset of patients who performed postdose serial spirometry at the baseline visit and week 12.||liters||Standard Error|Least Squares Mean
646664|NCT02141633|Secondary|Echocardiogram|to compare inhaled albuterol-induced changes in echocardiogram measuring mean pulmonary artery pressure (MPAP)in healthy current smokers and lifetime non-smokers as an index of endothelial function in the pulmonary circulation and to compare the results between smokers and non-smokers|MPAP before and 15 minutes after albuterol inhalation in smokers vs non-smokers|||ΔMPAP (mmHg)||Standard Error|Mean
646665|NCT02141633|Primary|Airway Blood Flow|compare inhaled albuterol-induced changes in airway blood flow (ΔQaw) in healthy current smokers and lifetime non-smokers as an index of endothelial function in the airway circulation and to compare the results between smokers and non-smokers|before and 15 minutes after albuterol inhalation|||ΔQaw (ul/min/ml)||Standard Error|Mean
646666|NCT02141620|Secondary|Peak Temperature|Oral temperature was measured with an automated monitor. Higher values represent greater temperature. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions.|This measure was completed at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.|||degrees Fahrenheit||Standard Error|Mean
646667|NCT02141620|Secondary|Peak Heart Rate|Heart rate was measured with an automated monitor. Higher values represent greater heart rate. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions.|This measure was completed at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.|||beats per minute||Standard Error|Mean
646668|NCT02141620|Secondary|Peak Systolic Blood Pressure|Systolic blood pressure was measured with an automated monitor. Higher values represent greater systolic pressure. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions.|This measure was completed at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.|||mm Hg||Standard Error|Mean
646669|NCT02141620|Secondary|Peak Diastolic Blood Pressure|Diastolic blood pressure was measured with an automated monitor. Higher values represent greater diastolic pressure. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions.|This measure was completed at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.|||mm Hg||Standard Error|Mean
646670|NCT02141620|Secondary|"Peak Ratings of Talkative/Friendly on the Visual Analog Scale"|"Subjects rated their feelings of Talkative/Friendly on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
646671|NCT02141620|Secondary|"Peak Ratings of Willing to Take Again on the Visual Analog Scale"|"Subjects rated their feelings of Willing to Take Again on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
646672|NCT02141620|Secondary|"Peak Ratings of Stimulated on the Visual Analog Scale"|"Subjects rated their feelings of Stimulated on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
646673|NCT02141620|Secondary|"Peak Ratings of Sluggish/Fatigued/Lazy on the Visual Analog Scale"|"Subjects rated their feelings of Sluggish/Fatigued/Lazy on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
646674|NCT02141620|Secondary|"Peak Ratings of Shaky/Jittery on the Visual Analog Scale"|"Subjects rated their feelings of Shaky/Jittery on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
646827|NCT02138097|Secondary|Treatment Discontinuation for Marketscan Patients|Number of patients with a treatment gap of >=6 months (i.e., no dispensing of non-insulin hypoglycemic agents within 6 months after the end of days supplied)|up to 12 months|All subjects in Marketscan cohort||participants/1000 participant years|||Number
646676|NCT02141620|Secondary|"Peak Ratings of Restless on the Visual Analog Scale"|"Subjects rated their feelings of Restless on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
646677|NCT02141620|Secondary|"Peak Ratings of Performance Improved on the Visual Analog Scale"|"Subjects rated their feelings of Performance Improved on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
646678|NCT02141620|Secondary|"Peak Ratings of Performance Impaired on the Visual Analog Scale"|"Subjects rated their feelings of Performance Impaired on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
646679|NCT02141620|Secondary|"Peak Ratings of Willing to Pay For on the Visual Analog Scale"|"Subjects rated their feelings of Willing to Pay For on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
646680|NCT02141620|Secondary|"Peak Ratings of Nervous/Anxious on the Visual Analog Scale"|"Subjects rated their feelings of Nervous/Anxious on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
646681|NCT02141620|Secondary|"Peak Ratings of Nauseous on the Visual Analog Scale"|"Subjects rated their feelings of Nauseous on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
646682|NCT02141620|Secondary|"Peak Ratings of Like Drug on the Visual Analog Scale"|"Subjects rated their feelings of Like Drug on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
646683|NCT02141620|Secondary|"Peak Ratings of Irregular/Racing Heartbeat on the Visual Analog Scale"|"Subjects rated their feelings of Irregular/Racing Heartbeat on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
646684|NCT02141620|Secondary|"Peak Ratings of High on the Visual Analog Scale"|"Subjects rated their feelings of High on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
646685|NCT02141620|Secondary|"Peak Ratings of Good Effects on the Visual Analog Scale"|"Subjects rated their feelings of Good Effects on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
646686|NCT02141620|Secondary|"Peak Ratings of Euphoric on the Visual Analog Scale"|"Subjects rated their feelings of Euphoric on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
646687|NCT02141620|Secondary|"Peak Ratings of Bad Effects on the Visual Analog Scale"|"Subjects rated their feelings of Bad Effects on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
646688|NCT02141620|Secondary|"Peak Ratings of Any Effect on the Visual Analog Scale"|"Subjects rated their feelings of Any Effect on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
646689|NCT02141620|Secondary|"Peak Ratings of Active, Alert, Energetic on the Visual Analog Scale"|"Subjects rated their feelings of Active, Alert, Energetic on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
646690|NCT02141620|Secondary|Peak Score on Stimulant Subscale of the Adjective Rating Scale|"Subjects completed 16 items that loaded into the Stimulant Subscale of the Adjective Rating Scale. The items were rated 0-4 on a Likert-type scale and the sum for the 16 sedative items was summed to yield the Stimulant Subscale score. The maximum score for this scale was 64, the minimum was 0. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
646691|NCT02141620|Secondary|Peak Score on Sedative Subscale of the Adjective Rating Scale|"Subjects completed 16 items that loaded into the Sedative Subscale of the Adjective Rating Scale. The items were rated 0-4 on a Likert-type scale and the sum for the 16 sedative items was summed to yield the Sedative Subscale score. The maximum score for this scale was 64, the minimum was 0. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
646692|NCT02141620|Primary|Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative|The reinforcing effects of cocaine were determined using a modified progressive ratio procedure (Stoops et al., 2010) in which subjects made 6 choices between available each available cocaine dose and money (US$0.25). Reinforcing effects are measured for each cocaine dose during both buspirone and placebo maintenance.|One test per cocaine dose level per intervention for each participant over his/her approximate 2 week inpatient admission.|||Number of Cocaine Choices||Standard Deviation|Mean
646693|NCT02141581|Other Pre-specified|Frequency of Vaccine-specific Antibody Secreting Cells on Day 5 and Day 7 After Vaccination||Baseline to Day 7||||||
646694|NCT02141581|Secondary|Number of Participants With Related Adverse Events|Number of participants with Related Adverse Events with a 0% Frequency Threshold|Baseline to Day 28|||Participants|||Count of Participants
646695|NCT02141581|Primary|Number of Participants From Each Arm Who Received Influenza Vaccine||Baseline to Day 28|||Participants|||Count of Participants
646696|NCT02141516|Primary|Number Of Subjects With Unsolicited Adverse Events (AEs).|Safety was assessed as the number of subjects who reported unsolicited AEs collected from Day1 through Day 7 after any vaccination; serious adverse events (SAEs), AEs leading to withdrawal and medically attended AEs were collected throughout the study period (Day1-Day 91).|At Day1 through Day 7 after any vaccination and throughout the study period (Day 1 to Day 91)|Analysis was done on the Unsolicited Safety Set (all subjects in the exposed set with postvaccination unsolicited AE records).||participants|||Number
646697|NCT02141516|Secondary|Number of Subjects Reporting Solicited Local and Systemic AEs.|Reactogenicity was presented in terms of percentages of subjects reporting solicited local and systemic AEs and other indicators.|From Day 1 until Day 7 after any vaccination.|Analysis was done on Solicited Safety Set (all subjects in the exposed set with any solicited AE data).||participants|||Number
646698|NCT02141516|Primary|Percentage of Subjects With Four-fold Increases in ELISA Concentrations Against the Vaccine Antigen 287-953.|Antibody responses were assessed in terms of percentage of subjects achieving 4-fold increase in ELISA concentrations against vaccine antigen 287-953 on Day 91 over baseline (Day 1), following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.|Day 91 (one month after the second dose of the study vaccine).|Analysis was done on Full Analysis Set||Percentage of Subjects||95% Confidence Interval|Number
646699|NCT02141516|Primary|ELISA GMRs of Antibodies Against Vaccine Antigen 287-953 Following a 2-dose Vaccination Schedule.|Immune responses were measured as ELISA GMRs of antibodies against vaccine antigen 287-953 following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.|Day 1 and Day 91 (one month after the second dose of the study vaccine).|Analysis was done on Full Analysis Set||Ratios||95% Confidence Interval|Geometric Mean
646700|NCT02141516|Primary|Geometric Mean Concentrations (GMCs) of Antibodies Against Vaccine Antigen 287-953 Following a 2-dose Vaccination Schedule.|Immune responses were measured as Enzyme-linked Immunosorbent Assay (ELISA) GMCs of antibodies against vaccine antigen 287-953 following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.|Day 1 and Day 91 (one month after the second dose of the study vaccine).|Analysis was done on Full Analysis Set||IU/mL||95% Confidence Interval|Geometric Mean
646701|NCT02141516|Primary|Percentages of Subjects With Four-fold Increases in hSBA Titers Against the Serogroup B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.|Antibody responses were assessed in terms of percentage of subjects achieving 4-fold increase in ELISA concentrations against vaccine antigen 287-953 on Day 91 over baseline (Day 1), following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.|Day 91 (one month after the second dose of the study vaccine).|Analysis was done on Full Analysis Set||Percentage of Subjects||95% Confidence Interval|Number
646702|NCT02141516|Primary|Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.|Immunogenicity was assessed in terms of GMTs against N. meningitidis serogroup B indicator strains (H44/76, 5/99, and NZ98/254) and M10713 strain following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.|Day 1 and Day 91 (one month after the second dose of the study vaccine).|Analysis was done on Full Analysis Set.||Titers||95% Confidence Interval|Geometric Mean
646703|NCT02141516|Primary|Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.|Immunogenicity was assessed in terms of GMRs against N. meningitidis serogroup B indicator strains (H44/76, 5/99, and NZ98/254) and M10713 strain following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.|Day 1 and Day 91 (one month after the second dose of the study vaccine).|Analysis was done on Full Analysis Set||Ratios||95% Confidence Interval|Geometric Mean
646704|NCT02141516|Primary|Percentages of Subjects With hSBA Titers ≥ 8 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.|Immunogenicity was assessed in terms of percentage of subjects with hSBA titers ≥ 8 against N. meningitidis serogroup B indicator strains (H44/76, 5/99, and NZ98/254) and M10713 strain following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.|Day 1 and Day 91 (one month after the second dose of the study vaccine).|Analysis was done on Full Analysis Set||Percentage of Subjects||95% Confidence Interval|Number
646705|NCT02141516|Primary|Percentages of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Titers ≥ 5 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.|Immunogenicity was assessed in terms of percentage of subjects with hSBA titers ≥ 5 against N. meningitidis serogroup B indicator strains (H44/76, 5/99, and NZ98/254) and M10713 strain following 2 doses of rMenB+Outer Membrane Vesicle (OMV) NZ, administered on Day 1 and Day 61.|Day 1 and Day 91 (one month after the second dose of the study vaccine)|Analysis was done on Full Analysis Set (all subjects in the enrolled set who: received a study vaccination and provided an evaluable serum sample at 1 month after the second dose of rMenB+OMV NZ, with assay result available for at least one of the serogroup B indicator strains or M10713 strain or ELISA).||Percentage of Subjects||95% Confidence Interval|Number
646706|NCT02141360|Primary|mTBI Progression Indicated by Clinical Neurological Characteristics, MRI Images, and Quantitative MRI Data From Novel Software|To determine associations between clinical neurological data, MR images, quantitative data from novel software post-processing (sponsor developed software including Volumetry, Kurtosis, Resting State [RS], functional magnetic resonance imaging [fMRI], and additional post-processing modules may be provided|Baseline to 3 months|Study was terminated and no subject outcome data were collected|||||
646707|NCT02141217|Secondary|Change From Baseline in Visual Analogue Scale Assessment of Swelling at Days 2, 5 and 7|Visual Analogue Scale (VAS) is used to measure the amount of swelling that the participant experiences. This scale has numerical ratings from 0 to 10. Zero indicates no swelling and 10 indicates worst possible swelling. Change in Pain/Swelling is calculated as VAS score at Baseline minus the score at a later time point (Day 2, 5 or 7).|Baseline, Days 2, 5 and 7|ITT-E Population. Only those participants available indicated time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT-E population.||Scores on a scale||95% Confidence Interval|Least Squares Mean
646708|NCT02141217|Secondary|Change From Baseline in the Visual Analogue Scale Assessment of Pain Score at Days 2, 5 and 7|Visual Analogue Scale (VAS) is used to measure the amount of pain that the participant experiences. This scale has numerical ratings from 0 to 10. Zero indicates no pain and 10 indicates worst possible pain. Change in Pain/Swelling is calculated as VAS score at Baseline minus the score at a later time point (Day 2, 5 or 7).|Baseline, Days 2, 5 and 7|ITT-E Population. Only those participants available indicated time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT-E population.||Scores on a scale||95% Confidence Interval|Least Squares Mean
646709|NCT02141217|Secondary|Number of Participants (Par.) Achieving Clinical Success (CS) (Cure or Improvement [Imp] in Signs [s] and Symptoms [sx] [s/sx]) Without Considering Clinical (cl) Judgment (Jdg) of the Investigator (Inv) at Day 5|CS is defined as cure or imp in s/sx of odontogenic infections. Cure is defined as the complete resolution of s/sx of infection present at Baseline (BL) and imp is defined as resolution of fever (if present at BL), >70% reduction in swelling and pain and imp in other s/sx such that no additional antimicrobial (ant) therapy is required. In event of cure or imp with complete resolution of fever and >70% reduction in swelling and pain, but ‘no change’ or ‘worsening from BL’ in other s/sx (like increased leucocyte count/tooth mobility), the inv’s opinion was sought on whether additional ant therapy was required. Par. that required no additional ant therapy were considered a 'success' while those requiring additional ant therapy were deemed a 'failure'. For a sensitivity analysis, all such par. with ‘no change’ or ‘worsening from BL’ in these other s/sx were considered as cl failures and termed ‘Without Considering Cl Jdg of Inv’, even though main s/sx are 'cured' or 'improved'. .|Day 5|ITT-E Population||Participants|||Number
646710|NCT02141217|Secondary|Number of Participants Achieving Clinical Success (Cure or Improvement) Considering Clinical Judgment of the Investigator at Day 5|Clinical success is defined as the achievement of cure or improvement in signs and symptoms of odontogenic infections. Cure is defined as the complete resolution of signs and symptoms of infection present at baseline, such that no additional antimicrobial therapy is required. Improvement is defined as the resolution of fever (if present at baseline), >70% reduction in swelling and pain and improvement in other signs and symptoms such that no additional antimicrobial therapy is required. Visual Analogue Scale (VAS) is used to measure the amount of pain and swelling that a participant experiences. This scale has numerical ratings from 0 to 10. Zero indicates no pain and 10 indicates worst possible pain.|Day 5|ITT-E Population. Only the participants with Day 5 assessments were considered for analysis.||Participants|||Number
646711|NCT02141217|Primary|Percentage of Participants Achieving Clinical Success (Cure or Improvement) Considering Clinical Judgment of the Investigator at the End of Treatment (Day 5 or Day 7)|Clinical success is defined as the achievement of cure or improvement in signs and symptoms of odontogenic infections. Cure is defined as the complete resolution of signs and symptoms of infection present at baseline, such that no additional antimicrobial therapy is required. Improvement is defined as the resolution of fever (if present at baseline), >70% reduction in swelling and pain and improvement in other signs and symptoms such that no additional antimicrobial therapy is required. Visual Analogue Scale (VAS) is used to measure the amount of pain and swelling that a participant experiences. This scale has numerical ratings from 0 to 10. Zero indicates no pain and 10 indicates worst possible pain.|Day 5 or Day 7 [End of treatment]|Intent-to-Treat (ITT) Population (randomized as per treatment allocation): all randomized participants who received at least one dose of study medication. If the post-Baseline assessment of clinical success response was missing then “Clinical Success” is considered as “No” i.e. the participant was treated as “Clinical Failure”.||Percentage of participants|||Number
646712|NCT02141217|Primary|Percentage of Participants Achieving Clinical Success (Cure or Improvement) Considering Clinical Judgment of the Investigator at the End of Treatment (Day 5 or Day 7)|Clinical success is defined as the achievement of cure or improvement in signs and symptoms of odontogenic infections. Cure is defined as the complete resolution of signs and symptoms of infection present at baseline, such that no additional antimicrobial therapy is required. Improvement is defined as the resolution of fever (if present at baseline), >70% reduction in swelling and pain and improvement in other signs and symptoms such that no additional antimicrobial therapy is required. Visual Analogue Scale (VAS) is used to measure the amount of pain and swelling that a participant experiences. This scale has numerical ratings from 0 to 10. Zero indicates no pain and 10 indicates worst possible pain.|Day 5 or Day 7 [End of treatment]|Intent-To-Treat-Efficacy (ITT-E) Population: all participants in the ITT participants who had at least one post-Baseline assessment of clinical success response (clinical response based on assessment on odontogenic infection and VAS Score).||Percentage of participants|||Number
646713|NCT02141217|Primary|Percentage of Participants Achieving Clinical Success (Cure or Improvement) Considering Clinical Judgment of the Investigator at the End of Treatment (Day 5 or Day 7)|Clinical success is defined as the achievement of cure or improvement in signs and symptoms of odontogenic infections. Cure is defined as the complete resolution of signs and symptoms of infection present at baseline, such that no additional antimicrobial therapy is required. Improvement is defined as the resolution of fever (if present at baseline), >70% reduction in swelling and pain and improvement in other signs and symptoms such that no additional antimicrobial therapy is required. Visual Analogue Scale (VAS) is used to measure the amount of pain and swelling that a participant experiences. This scale has numerical ratings from 0 to 10. Zero indicates no pain and 10 indicates worst possible pain.|Day 5 or Day 7 [End of treatment]|Per-Protocol (PP) Population: all participants in the Intent-to-Treat (ITT) Population (defined as all randomized participants who received at least one dose of study medication) who were without major protocol violations and had end of treatment clinical response assessment available.||Percentage of participants|||Number
646714|NCT02140957|Secondary|Current Nighttime Bottle Use|Current nighttime bottle use.|2 years|||participants|||Number
646715|NCT02140957|Secondary|Current Bottle Use|Current daytime bottle use.|2 years|||participants|||Number
646716|NCT02140957|Primary|Change in Iron Depletion|Iron depletion (serum ferritin < 10 μg/L).|Baseline, 2 years|||percentage of participants|||Number
646717|NCT02140788|Secondary|Changes in Total Scores on the 4 Positive Brief Psychiatric Rating Scale (BPRS) Items|The four positive items are: Suspiciousness, Unusual Thought Content, Hallucinations, Conceptual Disorganization.|baseline, 2 weeks, 4 weeks|Patients were not randomized per protocol and the study was terminated. Data analysis was not performed.|||||
646718|NCT02140788|Secondary|Changes in Mole Percentages of Omega-3 PUFAs in Fasting Serum and RBC Membranes||baseline, 2 weeks, 4 weeks|Patients were not randomized per protocol and the study was terminated. Data analysis was not performed.|||||
646719|NCT02140788|Secondary|Changes in C-reactive Protein and Sedimentation Rates||baseline, 2 weeks, 4 weeks|Patients were not randomized per protocol and the study was terminated. Data analysis was not performed.|||||
646720|NCT02140788|Secondary|Changes in Fasting Levels of Non-HDL Cholesterol and Triglycerides||baseline, 2 weeks, 4 weeks|Patients were not randomized per protocol and the study was terminated. Data analysis was not performed.|||||
646721|NCT02140788|Primary|Change in Weight||baseline, 2 weeks, 4 weeks|Patients were not randomized per protocol and the study was terminated. Data analysis was not performed.|||||
646722|NCT02140645|Primary|Binary EMR Characteristic: Pancreatitis|"The missing EMR characteristic pancreatitis defined as participants with any note of prior pancreatitis.
The associations between claims-based covariates and missingness on EMR characteristics were investigated by estimating a logistic regression model (and multinomial logistic regression, depending on the number of categories for the EMR characteristic) for each EMR characteristic where an indicator for missing the EMR characteristic pancreatitis was the dependent variable and all claims-based covariates were included as independent variables.
The estimated value represented is actually prediction accuracy defined by C-statistics."|Up to 20 months|All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available.||Percentage of participants|||Number
646723|NCT02140645|Primary|Binary EMR Characteristic: Retinopathy|"The missing EMR characteristic retinopathy defined as participants with any note of diabetic retinopathy.
The associations between claims-based covariates and missingness on EMR characteristics were investigated by estimating a logistic regression model (and multinomial logistic regression, depending on the number of categories for the EMR characteristic) for each EMR characteristic where an indicator for missing the EMR characteristic retinopathy was the dependent variable and all claims-based covariates were included as independent variables.
The estimated value represented is actually prediction accuracy defined by C-statistics."|Up to 20 months|All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available.||Percentage of participants|||Number
646724|NCT02140645|Primary|Binary EMR Characteristic: Nephropathy|"The missing EMR characteristic nephropathy defined as participants with any note of diabetic nephropathy.
The associations between claims-based covariates and missingness on EMR characteristics were investigated by estimating a logistic regression model (and multinomial logistic regression, depending on the number of categories for the EMR characteristic) for each EMR characteristic where an indicator for missing the EMR characteristic nephropathy was the dependent variable and all claims-based covariates were included as independent variables.
The estimated value represented is actually prediction accuracy defined by C-statistics."|Upto 20 months|All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available.||Percentage of participants|||Number
646756|NCT02140164|Secondary|Change in Cystoid Macular Edema (CME) Based on Optical Coherence Tomography (OCT) Measurements in the Study Eye at 12 Months Compared to the Average of the Pre-treatment Values|Three visits (two pre-treatment and one baseline) were conducted prior to the receipt of investigational product (IP) and an average of the OCT measurements at these three visits was used as the pre-treatment value.|Pre-treatment and 12 Months|||microns||Standard Deviation|Mean
649988|NCT02063880|Primary|All-cause Mortality||6 months post-HAART initiation|||participants|||Number
646725|NCT02140645|Primary|Binary EMR Characteristic: Neuropathy|"The missing EMR characteristic neuropathy defined as participants with any note of diabetic neuropathy.
The associations between claims-based covariates and missingness on EMR characteristics were investigated by estimating a logistic regression model (and multinomial logistic regression, depending on the number of categories for the EMR characteristic) for each EMR characteristic where an indicator for missing the EMR characteristic neuropathy was the dependent variable and all claims-based covariates were included as independent variables.
The estimated value represented is actually prediction accuracy defined by C-statistics."|Up to 20 months|All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available.||Percentage of participants|||Number
646726|NCT02140645|Primary|Missing EMR Characteristic: Diastolic BP|"The missing EMR characteristic diastolic BP defined as value in 6 months prior to and including index date.
The associations between claims-based covariates and missingness on EMR characteristics were investigated by estimating a logistic regression model (and multinomial logistic regression, depending on the number of categories for the EMR characteristic) for each EMR characteristic where an indicator for missing the EMR characteristic diastolic BP was the dependent variable and all claims-based covariates were included as independent variables.
The estimated value represented is actually prediction accuracy defined by C-statistics."|Up to 20 months|All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available.||mmHg||Standard Deviation|Mean
646727|NCT02140645|Primary|Missing EMR Characteristic: Systolic BP (Blood Pressure)|"The missing EMR characteristic systolic BP defined as value in 6 months prior to and including index date.
The associations between claims-based covariates and missingness on EMR characteristics were investigated by estimating a logistic regression model (and multinomial logistic regression, depending on the number of categories for the EMR characteristic) for each EMR characteristic where an indicator for missing the EMR characteristic systolic BP was the dependent variable and all claims-based covariates were included as independent variables.
The estimated value represented is actually prediction accuracy defined by C-statistics."|Up to 20 months|All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available.||mmHg||Standard Deviation|Mean
646728|NCT02140645|Primary|Missing EMR Characteristic: Total Cholesterol|"The missing EMR characteristic total cholesterol defined as value in 6 months prior to and including index date.
The associations between claims-based covariates and missingness on EMR characteristics were investigated by estimating a logistic regression model (and multinomial logistic regression, depending on the number of categories for the EMR characteristic) for each EMR characteristic where an indicator for missing the EMR characteristic total cholesterol was the dependent variable and all claims-based covariates were included as independent variables.
The estimated value represented is actually prediction accuracy defined by C-statistics."|Up to 20 months|All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available.||mg/dl||Standard Deviation|Mean
646729|NCT02140645|Primary|Missing EMR Characteristic: eGFR (Glomerular Filtration Rate)|"The missing EMR characteristic eGFR defined as value in 6 months prior to and including index date.
The associations between claims-based covariates and missingness on EMR characteristics were investigated by estimating a logistic regression model (and multinomial logistic regression, depending on the number of categories for the EMR characteristic) for each EMR characteristic where an indicator for missing the EMR characteristic eGFR was the dependent variable and all claims-based covariates were included as independent variables.
The estimated value represented is actually prediction accuracy defined by C-statistics."|Upto 20 months|All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available.||ml/min per 1.73 m^2||Standard Deviation|Mean
646730|NCT02140645|Primary|Missing EMR Characteristic: HbA1c (Hemoglobin A1c (Glycosylated Hemoglobin))|"The missing EMR characteristic HbA1c defined as value in 6 months prior to and including index date.
The associations between claims-based covariates and missingness on EMR characteristics were investigated by estimating a logistic regression model (and multinomial logistic regression, depending on the number of categories for the EMR characteristic) for each EMR characteristic where an indicator for missing the EMR characteristic HbA1c was the dependent variable and all claims-based covariates were included as independent variables.
The estimated value represented is actually prediction accuracy defined by C-statistics."|Up to 20 months|All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available.||Percentage||Standard Deviation|Mean
646731|NCT02140645|Primary|Missing EMR Characteristic: BMI (Continuous)|"The missing EMR characteristic BMI is BMI value. Linear regression models were ran using a prioritized list of claims-based covariates as predictors and the value of select EMR-based clinical characteristics BMI as continuous outcomes.
The estimated value represented is actually prediction accuracy defined by R-squared."|Up to 20 months|All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available.||Kg/m^2||Standard Deviation|Mean
646732|NCT02140645|Primary|Missing EMR Characteristic: BMI (Body Mass Index)|"The missing EMR characteristic BMI defined as not obese, overweight, obese, severe obesity.
The associations between claims-based covariates and missingness on EMR characteristics were investigated by estimating a logistic regression model (and multinomial logistic regression, depending on the number of categories for the EMR characteristic) for each EMR characteristic where an indicator for missing the EMR characteristic BMI was the dependent variable and all claims-based covariates were included as independent variables.
The estimated value represented is actually prediction accuracy defined by C-statistics."|Up to 20 months|All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available.||Percentage of participants|||Number
646733|NCT02140645|Primary|Missing EMR Characteristic: Duration of Diabetes (Continuous)|"The missing EMR characteristic duration of diabetes defined as starting year/starting age of diabetes.
Linear regression models were ran using a prioritized list of claims-based covariates as predictors and the value of select EMR-based clinical characteristics duration of diabetes as continuous outcomes.
The estimated value represented is actually prediction accuracy defined by R-squared."|Up to 20 months|All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available.||Months||Standard Deviation|Mean
646734|NCT02140645|Primary|Missing EMR Characteristic: Duration of Diabetes|"The missing EMR characteristic duration of diabetes defined as >7, 5-6, 3-5, 1-3, <1 (in years) in duration.
The associations between claims-based covariates and missingness on EMR characteristics were investigated by estimating a logistic regression model (and multinomial logistic regression, depending on the number of categories for the EMR characteristic) for each EMR characteristic where an indicator for missing the EMR characteristic duration of diabetes was the dependent variable and all claims-based covariates were included as independent variables.
The estimated value represented is actually prediction accuracy defined by C-statistics."|Up to 20 months|All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available.||Percentage of participants|||Number
646735|NCT02140645|Primary|Missing EMR (Electronic Medical Record) Characteristic: Smoking|"The missing EMR characteristic smoking defined as current, unknown, versus past/never smoker.
The associations between claims-based covariates and missingness on EMR characteristics were investigated by estimating a logistic regression model (and multinomial logistic regression, depending on the number of categories for the EMR characteristic) for each EMR characteristic where an indicator for missing the EMR characteristic smoking was the dependent variable and all claims-based covariates were included as independent variables.
The estimated value represented is actually prediction accuracy defined by C-statistics."|Up to 20 months|All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available.||Percentage of participants|||Number
646736|NCT02140593|Secondary|The Surgical Rating Score During Fascial Closure|After last suture of fascial closure surgical conditions are rated on a 5 point scale|Immediatly after fascial closure|||units on a scale||Full Range|Mean
646737|NCT02140593|Primary|Surgical Rating Score|The final score for the surgical conditions of a patient defined as the average of all scores provided during the surgical procedure. (Rated on a 5 point subjective rating scale; 1: extremely poor, 2: poor, 3: acceptable, 4: good, 5: optimal)|After randomization every 30 minutes during the operation from first incision to last suture of fascial closure, up to 300 minutes|||units on a scale||Full Range|Median
646738|NCT02140372|Secondary|Platelet Adhesion: 2 Hours||2 hours|||percentage of adhered platelets||Inter-Quartile Range|Median
646739|NCT02140372|Secondary|Platelet Adhesion: Baseline||Baseline|||percentage of adhered platelets||Inter-Quartile Range|Median
646740|NCT02140372|Secondary|Light Transmission Aggregometry: 2 Hours|In response to adenosine epinephrine|2 hours|||percentage of max platelet aggregation||Inter-Quartile Range|Median
646741|NCT02140372|Secondary|Light Transmission Aggregometry: Baseline|In response to adenosine epinephrine|baseline|||percentage of max platelet aggregation||Inter-Quartile Range|Median
646742|NCT02140372|Secondary|Light Transmission Aggregometry: 2 Hours|In response to adenosine diphosphate|2 hours|||percentage of max platelet aggregation||Inter-Quartile Range|Median
646743|NCT02140372|Primary|Monocyte Platelet Aggregate: 2 Hours||2 Hours|||percentage of monocyte-platelet aggregat||Inter-Quartile Range|Median
646744|NCT02140372|Secondary|Light Transmission Aggregometry: Baseline|In response to adenosine diphosphate|Baseline|||percentage of max platelet aggregation||Inter-Quartile Range|Median
646745|NCT02140372|Primary|Monocyte Platelet Aggregate: Baseline||Baseline|||percentage of monocyte-platelet aggregat||Inter-Quartile Range|Median
646746|NCT02140164|Secondary|Number of Severe Adverse Events||Study Duration, up to 16 Months|All participants were included in the safety analysis.||adverse events|||Number
646747|NCT02140164|Secondary|Number of Non-ocular Adverse Events||Study Duration, up to 16 Months|All participants were included in the safety analysis.||adverse events|||Number
646748|NCT02140164|Secondary|Number of Ocular Adverse Events||Study Duration, up to 16 Months|All participants were included in the safety analysis.||adverse events|||Number
646749|NCT02140164|Secondary|Number of Study Eyes Achieving a 15-letter or More Worsening in Electronic Visual Acuity (EVA) at 12 Months as Compared to Baseline|Visual Acuity was measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method.|Baseline and 12 Months|||eyes|eyes||Number
646750|NCT02140164|Secondary|Change in Visual Field as Measured by HVF 30-2 Visual Field Testing at 12 Months as Compared to the Average of Pre-treatment Values|Three visits (two pre-treatment and one baseline) were conducted prior to the receipt of investigational product (IP) and an average of the HVF 30-2 measurements at these three visits was used as the pre-treatment value.|Pre-treatment and 12 Months||06/2017||||
646751|NCT02140164|Secondary|Change in Visual Field as Measured by HVF 30-2 Visual Field Testing at 6 Months as Compared to the Average of Pre-treatment Values|Three visits (two pre-treatment and one baseline) were conducted prior to the receipt of investigational product (IP) and an average of the HVF 30-2 measurements at these three visits was used as the pre-treatment value.|Pre-treatment and 6 Months||06/2017||||
646752|NCT02140164|Secondary|Change in Microperimetry at 12 Months as Compared to the Average of Pre-treatment Values|Three visits (two pre-treatment and one baseline) were conducted prior to the receipt of investigational product (IP) and an average of the microperimetry measurements at these three visits was used as the pre-treatment value.|Pre-treatment and 12 Months||06/2017||||
646753|NCT02140164|Secondary|Change in Microperimetry at 6 Months as Compared to the Average of Pre-treatment Values|Three visits (two pre-treatment and one baseline) were conducted prior to the receipt of investigational product (IP) and an average of the microperimetry measurements at these three visits was used as the pre-treatment value.|Pre-treatment and 6 Months||06/2017||||
646754|NCT02140164|Secondary|Changes in Amplitude of Photopic and Scotopic Responses on Electroretinogram (ERG) Testing at 12 Months as Compared to the Average of Pre-treatment Values|This outcome measure will not be reported.|Pre-treatment and 12 Months|Participants had non-recordable ERGs; therefore, changes could not be measured.|||||
646755|NCT02140164|Secondary|Changes in Amplitude of Photopic and Scotopic Responses on Electroretinogram (ERG) Testing at 6 Months as Compared to the Average of Pre-treatment Values|This outcome measure will not be reported.|Pre-Treatment and 6 Months|Participants had non-recordable ERGs; therefore, changes could not be measured.|||||
646799|NCT02138838|Secondary|Percent Change in iPTH From Baseline to the Mean Value During Weeks 17 to 20||Baseline and weeks 17 to 20|This analysis was conducted using the full analysis set using last value carried forward imputation. Participants with no post-baseline values available were excluded from the analysis.||percent change||Standard Error|Least Squares Mean
646757|NCT02140164|Primary|Change in Cystoid Macular Edema (CME) Based on Optical Coherence Tomography (OCT) Measurements in the Study Eye at 6 Months Compared to the Average of the Pre-treatment Values.|Three visits (two pre-treatment and one baseline) were conducted prior to the receipt of investigational product (IP) and an average of the OCT measurements at these three visits was used as the pre-treatment value.|Pre-treatment and 6 Months|Participants receiving investigational product (IP) at the Month 6 visit were included in the primary efficacy analysis.||microns||Standard Deviation|Mean
646758|NCT02140060|Primary|Mean IOP at Week 6|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye (study eye) was used for the analysis.|Week 6, 8 AM, 10 AM, 12 PM, 4 PM, and 8 PM|"This analysis population includes all subjects who were randomized, received study medication, and completed at least 1 scheduled on-therapy study visit, based upon a last on-therapy carried forward (LOCF) analysis. Here, n is the number of subjects with non-missing values at the specific time point for each arm, respectively."||mmHg||Standard Error|Mean
646759|NCT02139982|Primary|Changes in Cross-sectional Area of Radial/Ulnar Artery From Baseline to 30min After Specific Nerve Block Followed by 30min After Brachial Plexus Block(Phase 1)|The cross-sectional area(CSA, cm2) of Radial/ulnar Artery was assessed with B-mode imaging. Probe was kept perpendicular to the long axis of the artery to obtain the largest oval arterial section. The image at end diastole was chosen and measured with the cine loop.|baseline(t0), 30 min after specific nerve block(t1), 30 min after brachial plexus block(t2)|||cm^2||Standard Deviation|Mean
646760|NCT02139982|Secondary|Changes in Skin Temperature From Baseline to 30min After Brachial Plexus Block(Phase 2)|Skin temperature was measured at the thenar. change= 30min after brachial plexus block minus baseline|Baseline,30 min after brachial plexus block|||℃||Standard Deviation|Mean
646761|NCT02139982|Secondary|Success of Brachial Plexus Block ( Phase 2)|Success of Brachial Plexus Block(BPB) was defined as the absence of sensation to in all innervation areas of above four nerves (musculocutaneous, ulnar, radial, and median nerves) 30min. after the BPB and no pain during the surgery.|30 min after brachial plexus block|||participants|||Number
646762|NCT02139982|Secondary|Changes in Skin Temperature From Baseline to 30 Min After Specific Nerve Block Followed by 30 Min After Brachial Plexus Block(Phase 1)|Skin temperature(Ts) was measured at four different points within the cutaneous innervation areas of the musculocutaneous(lateral skin of forearm), ulnar(hypothenar region), radial (thumb-index web) and median(thenar) Specific points were located with skin marker to provide consistency of measurement.|baseline, 30 min after specific nerve block, 30 min after brachial plexus block|||℃||Standard Deviation|Mean
646763|NCT02139982|Primary|Changes in Hemodynamic Parameters of Brachial Artery From Baseline to 30min After Brachial Plexus Block(Phase 2)|"These parameters included peak systolic velocity (PSV, cm/s), end-diastolic velocity (EDV, cm/s), time average maximum velocity (TAMAX), resistance index (RI), and pulsatility index (PI),The cross-sectional area of the artery imaging.Blood flow (BF) = TAMAX× CSA×60s.
Relative ratio of hemodymanic parameter=30 min after brachial plexus block divide by baseline"|baseline, 30 min after brachial plexus block|||ratio||Inter-Quartile Range|Median
646764|NCT02139982|Primary|Changes in Hemodynamic Parameters of Radial/Ulnar Artery From Baseline to 30min After Specific Nerve Block Followed by 30min After Brachial Plexus Block(Phase 1)|These parameters included peak systolic velocity (PSV, cm/s), end-diastolic velocity (EDV, cm/s), time average maximum velocity (TAMAX),and was measured by Pulsed-wave Doppler(PWD) ultrasound.|baseline(t0), 30 min after specific nerve block(t1), 30 min after brachial plexus block(t2)|||cm/s||Standard Deviation|Mean
646765|NCT02139943|Primary|Percentage of Participants With Adverse Events||Up to 22 Weeks|Safety Analysis Set included all randomized participants who took at least 1 dose of double-blind study drug.||percentage of participants|||Number
646766|NCT02139943|Primary|Percentage of Participants With Hemoglobin A1c (HbA1c) Reduction Greater Than or Equal to (>=) 0.4 Percent (%) and no Increase in Body Weight|Clinical response at Weeks 18 was assessed by the percentage of participants with Hemoglobin A1c (HbA1c) reduction greater than or equal to 0.4 % and had no increase in body weight.|Week 18|Modified intent-to-treat analysis set included all randomized participants who took at least 1 dose of double-blind study drug. 'N (Number of Participants Analyzed)’ signifies participants who were evaluable for this outcome measure.||percentage of participants|||Number
646767|NCT02139878|Secondary|Glucose|Plasma blood glucose concentrations|Up to 4 weeks|||mmol/L||Standard Error|Mean
646768|NCT02139878|Primary|Blood Pressure|Systolic blood pressure|Up to 4 weeks|||mm Hg||Standard Error|Mean
646769|NCT02139644|Secondary|Patients With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period|An adverse event was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relationship of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 to Week 12 of the Treatment Period|Safety population||Participants|||Count of Participants
646770|NCT02139644|Secondary|Kaplan-Meier Estimates for Time to 15% and 12% Improvement From Baseline in FEV1 Postdose on Day 1|"A subset of approximately 300 patients who performed postdose serial spirometry is based on sample size calculation. Baseline FEV1 was the average of 2 FEV1 measurements (30 and 10 minutes predose) on Day 1. If one of these was missing, the other measurement was used as baseline value. If both were missing, baseline was treated as missing. Time to target improvement (15% or 12%) was defined as the time elapsed from the time of first dose to the first time the target improvement in FEV1 was achieved. If an exact target increase was not achieved at a measured timepoint, then the time was estimated by linear interpolation between the timepoint when target was reached and the timepoint immediately before. Patients who did not achieve the target improvement were censored at the time of last serial spirometry assessment.
Values of 9999 indicate the values could not be estimated which happened when the estimated probability of not achieving target is more than 50%."|Day 1 of the Treatment Period (predose and postdose)|Full analysis set: a subset of patients who performed postdose serial spirometry on Day 1||hours||95% Confidence Interval|Median
646771|NCT02139644|Secondary|Change From Baseline in the Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ(S)) Score at Endpoint for Patients >=18 Years Old|"The AQLQ(S) (September 2010 version; patients aged ≥18 years) was self-administered by the patients at the investigational center at the randomization visit and at Week 12 or end of trial. The questionnaire is a tool to measure the impact of asthma on a patient’s quality of life (physical, emotional, social, and occupational) with a recall period of 2 weeks. The AQLQ(S) was administered only to patients 18 years and older. The 32 individual questions in the AQLQ were equally weighted. The overall AQLQ score was the mean of the responses to each of the 32 questions, and ranged from 1 to 7. A score of 7.0 indicated that the patient had no impairments due to asthma and a score of 1.0 indicated severe impairment.
Positive change from baseline scores indicate improved quality of life."|Day 1 (predose, baseline), end of trial (up to week 12)|FAS patients who contributed at least once to analysis and were >= 18 years old||units on a scale||Standard Error|Least Squares Mean
646772|NCT02139644|Secondary|Kaplan-Meier Estimate of Probability of Remaining in Study At Week 12|The analysis of probability of remaining in the study at Week 12 used the time to patient withdrawal for worsening asthma, defined as the number of days elapsed from the date of randomization to the date of withdrawal due to worsening asthma. Patients who were lost to follow-up, who had not withdrawn due to worsening asthma by week 12, or who had withdrawn due to reasons other than worsening asthma were right-censored at the date of last assessment.|up to Week 12 of the Treatment Period|FAS||probability||95% Confidence Interval|Number
646773|NCT02139644|Secondary|Change From Baseline in the Weekly Average of the Total Daily (24-hour) Use of Albuterol/Salbutamol Inhalation Aerosol Over the 12-Week Treatment Period|Patients recorded the number of inhalations of rescue medication (albuterol/salbutamol HFA MDI) each AM and PM in the diary. The average number of daily inhalations over the 7 days before the randomization visit was the baseline value. The weekly average was based on the available data for the 7 days before each analysis week. The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using a mixed model for repeated measures.|Days -6 to Day 1 (predose, baseline), up to week 12|FAS of patients who contributed at least once to the analysis||puffs||Standard Error|Least Squares Mean
646774|NCT02139644|Secondary|Change From Baseline in the Weekly Average of the Total Daily Asthma Symptom Score Over the 12-Week Treatment Period|"The total daily asthma symptom score is the average of the daytime and nighttime scores as recorded in the patient diary (range 0-9).
Daytime Symptom Score:
0=No symptoms
Symptoms for 1 short period
Symptoms for 2+ short periods
Symptoms for most of the day - did not affect normal daily activities
Symptoms for most of the day - did affect normal daily activities
Symptoms so severe that I could not go to work or perform normal daily activities
Nighttime Symptom Score (determined in the AM):
0=No symptoms
Symptoms causing me to wake once (or wake early)
Symptoms causing me to wake twice or more (including waking early)
Symptoms causing me to be awake for most of the night
Symptoms so severe that I did not sleep Baseline was the average of recorded scores over the 7 days before randomization. The change from baseline in the weekly average over weeks 1 to 12 was analyzed using an mixed model for repeated measures (MMRM)."|Days -6 to Day 1 (predose, baseline) to Week 12|Full analysis set of patients who contributed at least once to the analysis.||units on a scale||Standard Error|Least Squares Mean
646775|NCT02139644|Secondary|Change From Baseline in the Weekly Average of the Daily Morning Trough Peak Expiratory Flow (PEF) Over the 12 Week Treatment|Morning PEF tests were performed before administration of study drug or rescue medications (data were excluded if the time of PEF measurement was more than 5 minutes after the dose time). The patient recorded the highest value of 3 measurements obtained in the patient diary. The baseline PEF was the average value of recorded (nonmissing) morning assessments over the 7 days prior to randomization on Day 1. For efficacy analyses of weekly average morning PEF measurements, values were the averages based on available data for that week.|Days -6 to Day 1 (predose), Day 1 (postdose) daily until Week 12|Full analysis set of patients who contributed at least once to the analysis.||liters/minute||Standard Error|Least Squares Mean
646776|NCT02139644|Primary|Change From Baseline in Morning Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12|"Trough FEV1 was a morning spirometry taken predose and pre-rescue bronchodilator. If the patient inadvertently administered asthma medication/study drug at home on the AM of the visit, or if the patient took rescue medication within 6 hours of testing, the visit was rescheduled.
The baseline for predose FEV1 was defined as the average of the 30-minute and 10-minute predose measurements obtained at the randomization visit (Day 1)."|Day 1 (predose, baseline), Week 12|Full analysis set||liters||Standard Error|Least Squares Mean
646777|NCT02139644|Primary|Standardized Baseline-Adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Effect Curve From Time Zero to 12 Hours Postdose (FEV1 AUEC0-12h) at Week 12|"A subset of approximately 300 patients who performed postdose serial spirometry is based on sample size calculation. Data from these assessments were used to analyze the primary endpoint of baseline adjusted FEV1 AUEC0-12h at week 12 using the trapezoidal rule based on actual time of measurement. It was standardized by dividing it by the number of hours between the start time of dose administration and the end time of the last nonmissing FEV1 measurement.
The baseline FEV1 was the average of the 2 predose FEV1 measurements (30 and 10 minutes predose). If 1 of these was missing, the nonmissing value was used; if both were missing, baseline was treated as missing. Baseline-adjusted FEV1 was calculated as postdose FEV1 after subtracting the baseline FEV1 value."|Day 1 (predose, baseline), Week 12 and was performed at the following times relative to the administration of study drug (±5 minutes): 15 and 30 minutes and 1, 2, 3, 4, 6, 8, 10, and 12 hours|Full analysis set: a subset of patients who performed postdose serial spirometry at the baseline visit and week 12||liters||Standard Error|Least Squares Mean
646778|NCT02139228|Secondary|Percentages of Subjects With Anti-PRP Concentrations ≥1.0 μg/mL and ≥0.15 μg/mL at Day 1 (4 Years Post Booster Dose Administered in Study V37_07E1)|Immunogenicity was measured as the percentages of subjects with Anti-PRP Concentrations ≥1.0 μg/mL and ≥0.15 μg/mL approximately 4 years after booster vaccination with either Hib-CRM197 or Hib-TT in V37_07E1 trial.|At Day 1 (4 years post booster dose administered in study V37_07E1)|Analysis was evaluated on the Per Protocol set (PPS) (i.e. All subjects in the All Enrolled Set with no reportable protocol deviations).||Percentage of subjects||95% Confidence Interval|Number
646824|NCT02138097|Secondary|Persistence at 3 Months for United Healthcare Patients|Fraction of non-insulin hypoglycemic initiators with continued dispensing. Patients will be classified as persistent if they possess medication at 3 months. Grace period of 30 days will be allowed.|3 months|All patients in United Healthcare cohort||Percentage of participants|||Number
646779|NCT02139228|Primary|Geometric Mean Anti-PRP (Polyribosyl Ribitol Phosphate) Concentrations at Day 1 (4 Years Post Booster Dose Administered in Study V37_07E1)|Immunogenicity was measured as geometric mean of Anti- PRP Concentrations, approximately 4 years after booster vaccination with either Hib-CRM197 or Hib-TT in children participating in previous V37_07E1 trial.|At Day 1 (4 years post booster dose administered in study V37_07E1)|Analysis was evaluated on the Per Protocol set (PPS)-All subjects in the All Enrolled Set with no reportable protocol deviations.||Concentration in μg/mL||95% Confidence Interval|Geometric Mean
646780|NCT02139176|Secondary|Male Linkage to Care|It will be assessed whether newly diagnosed HIV-infected male partners are linked to care within one month of learning their HIV positive result with their partner. This will be assessed from abstraction of routine clinic records at Martin Preuss Center.|one month from male presentation to the clinic|These are only the HIV-infected men who participated in the study who were HIV-infected and not already engaged in care. That is why it is only a subset of the larger population.||partners linked to care|||Number
646781|NCT02139176|Secondary|Female First Option B+ Follow-up Visit|It will be assessed whether the female participants return for their first Option B+ visit (using the clinic's routine Option B+ records). The number retained will be compared.|three months|||participants|||Number
646782|NCT02139176|Primary|Number of Women Who Came With Their Partners and Received Couple Counseling and Testing|Based on whether the female partner brings her male partner to the antenatal clinic for couple HIV counseling and testing (as recorded on study case report forms) as the primary measure of uptake. We will compare time to couple HIV counseling and testing between groups using the Kaplan Meier method and a log rank test.|three months|||Female participants receiving CHTC|||Number
646783|NCT02139137|Secondary|Change in Functional Impairment; Sheehan Disability Scale|Range: 0-30; greater values indicate greater disability severity ratings|Baseline, Week 4|Data at one time point for one participant in the LIC condition are not available.||units on a scale||Standard Deviation|Mean
646784|NCT02139137|Secondary|Change in General Anxiety: Spielberger State-Trait Anxiety Inventory|Range: 20-80; higher scores indicate greater symptom severity|Baseline, Week 4|||units on a scale||Standard Deviation|Mean
646785|NCT02139137|Secondary|Change in Depression: Beck Depression Inventory|Scale Range: 0-63; higher scores indicate greater symptom severity|Baseline, Week 4|||units on a scale||Standard Deviation|Mean
646786|NCT02139137|Secondary|Clinician Administered PTSD Scale Total Score - Responder Status|Number of Participants Who Responded According to Clinician Administered PTSD Scale Total Score|Week 4|Number of participants analyzed is based on the number of participants who completed the post-treatment CAPS interview.||Participants|||Count of Participants
646787|NCT02139137|Primary|Change in Clinician Administered PTSD Scale; Re-experiencing|"Model estimations of the means and standard deviation of posttreatment score at the mean level of baseline severity reported below.
Scale range: 0-40, higher values indicate greater symptom severity"|Baseline, Week 4|||units on a scale||Standard Error|Mean
646788|NCT02139046|Secondary|Percentage of Participants With Serum Urate <6.0 mg/dL at Month 3||Month 3|FAS included all participants who were randomized and received at least 1 dose of double-blind study medication. Participants who discontinued double-blind study drug prior to the Month 3 visit were considered treatment failures, i.e. to have serum urate ≥ 5.0 mg/dL.||percentage of participants|||Number
646789|NCT02139046|Secondary|Percentage of Participants With at Least One Gout Flare Requiring Treatment|"A participant was considered to have a gout flare if the following criteria were met:
Participant-reported acute particular pain typical of a gout attack that was deemed by participant and/or investigator to require treatment and was treated with colchicine, nonsteroidal anti-inflammatory drugs (NSAIDs) or steroids, Participant experienced at least 3 or more of: 1) Joint swelling, 2) Redness, 3) Tenderness, 4) Pain, Participant experienced at least one or more of: 1) Rapid onset of pain, 2) Decreased range of motion, 3) Joint warmth, 4) Other symptoms similar to a prior gout flare."|Baseline to Month 3|FAS included all participants who were randomized and received at least 1 dose of double-blind study medication.||percentage of participants|||Number
646790|NCT02139046|Primary|Percentage of Participants With Serum Urate <5.0 mg/dL at Month 3||Month 3|Full Analysis Set (FAS) included all participants who were randomized and received at least 1 dose of double-blind study medication. Participants who discontinued double-blind study drug prior to the Month 3 visit were considered treatment failures, i.e. to have serum urate ≥ 5.0 mg/dL.||percentage of participants|||Number
646791|NCT02139007|Secondary|Osteonecrosis of the Jaw|Patients self report diagnoses of osteonecrosis of the jaw 6 months post enrollment via follow-up survey .|Baseline to 6 months following enrollment|||Participants|||Count of Participants
646792|NCT02139007|Secondary|Atypical Femoral Fracture|Patient reported fracture rate at 6 months after enrollment via follow-up survey|Baseline to 6 months following enrollment|||Participants|||Count of Participants
646793|NCT02139007|Secondary|Clinical Fracture Rate|Patient reported fracture rate at 6 months following enrollment via survey.|Baseline to 6 months following enrollment|||Participants|||Count of Participants
646794|NCT02139007|Primary|All Study Sites-Length of Time to 1st Participant Enrolled|Mean time from study initiation to 1st participant enrolled.|Length of time t for sites to recruit/enroll 1st participant|For sites enrolling at least one patient, the average (SD) time from contract execution to the first patient recruited.||Months|Sites|Standard Deviation|Mean
646795|NCT02139007|Primary|All Study Sites--Length of Time to Site IRB Approval|Mean time to gain site IRB approval|Length of time to site IRB approval|||Days|Sites|Standard Deviation|Mean
646796|NCT02139007|Primary|All Study Sites--Length of Contracting Procedures|Mean time Between Clinical Site Recruitment and Contract Execution|Length of time Between Clinical Site Recruitment and Contract Execution|Nine sites from six states (AL, CO, NM, CT, CA, and PA) participated in this pilot study.||Months|Sites|Standard Deviation|Mean
646797|NCT02138838|Secondary|Change in Serum Phosphorus From Baseline to the Mean Value During Weeks 17 to 20||Baseline and weeks 17 to 20|This analysis was conducted using the full analysis set using last value carried forward imputation. Participants with no post-baseline values available were excluded from the analysis.||mg/dL||Standard Error|Least Squares Mean
646798|NCT02138838|Secondary|Change in Corrected Serum Calcium From Baseline to the Mean Value During Weeks 17 to 20||Baseline and weeks 17 to 20|This analysis was conducted using the full analysis set using last value carried forward imputation. Participants with no post-baseline values available were excluded from the analysis.||mg/dL||Standard Error|Least Squares Mean
646800|NCT02138838|Secondary|Percentage of Participants Who Achieved a Mean iPTH ≤ 300 pg/mL (31.8 Pmol/L) During Weeks 17 to 20||Efficacy assessment period, weeks 17 to 20|This analysis was conducted using the full analysis set. For participants with no iPTH values in the EAP, the mean of the last 2 available postbaseline values was used. If only 1 postbaseline value was available, this value was used. If no postbaseline value was available, the participant was considered a non-responder.||percentage of participants|||Number
646801|NCT02138838|Primary|Percentage of Participants Who Achieved a ≥ 30% Reduction From Baseline in Mean Plasma Intact Parathyroid Hormone During the Efficacy Assessment Period|"Intact parathyroid hormone (iPTH) levels were measured at weeks 17, 18, 19 and 20; the mean value from these measurements was calculated.
This endpoint was specified as the the primary endpoint in all countries except the United States (US). In the US this endpoint was specified as a secondary efficacy endpoint."|Baseline and the efficacy assessment period (EAP), weeks 17 to 20|The full analysis set (all randomized participants) was used for this analysis. For participants with no iPTH values in the EAP, the mean of the last 2 available postbaseline values was used. If only 1 postbaseline value was available, this value was used. If no postbaseline value was available, the participant was considered a non-responder.||percentage of participants|||Number
646802|NCT02138838|Primary|Percentage of Participants Who Achieved a ≥ 30% Reduction From Baseline In Mean Plasma iPTH During Weeks 11 to 15|"Intact parathyroid hormone (iPTH) levels were measured at weeks 11 and 15; the mean value from these 2 measurements was calculated.
This endpoint was the primary endpoint in the US only."|Baseline and weeks 11 to 15|The analysis was conducted using the full analysis set; participants who had no week 11 or 15 iPTH values were considered non-responders (non-responder imputation).||percentage of participants|||Number
646803|NCT02138825|Secondary|Number of Participants With Clinical Worsening|The combined endpoint “time to clinical worsening”, made up of the following components, defined by the first occurrence: all-cause mortality; need for hospitalization due to worsening cardiopulmonary (CP) status, attributable to progression of disease (including but not limited to increased shortness of breath or increased leg swelling); >15% decrease in the 6MWD test; worsening of WHO functional class.|From baseline to week 26|Intent to treat (ITT) analysis set: participants randomized and received at least one dose of study medication.||Participants|||Number
646804|NCT02138825|Primary|Mean Change in 6 Minute Walking Distance (6MWD) From Baseline to Week 26|The 6MWD test is designed to evaluate a patient’s exercise capacity while performing an everyday activity.|Baseline to 26 weeks|Intent to treat (ITT) analysis set: participants randomized and received at least one dose of study medication.||Meter||Standard Deviation|Mean
646805|NCT02138747|Secondary|Number of Participants With Adverse Events|Safety was assessed by evaluation of treatment-emergent adverse events (TEAEs; frequency, severity, seriousness and relationship to study drug), AEs of special interest, vital signs (SBP, DBP, body temperature and pulse rate) and laboratory tests (liver function tests [LFTs]). Treatment-Emergent Adverse Event (TEAEs) were defined as any adverse event starting or worsening in the period from first dose of double-blind study drug until 15 days after last dose of double-blind study drug.|Baseline to EOT (Week 18) and follow up (Week 20)|Safety Analysis Set consisted of all participants who received at least 1 dose of double-blind study drug (SAF).||Participants|||Number
646806|NCT02138747|Secondary|Change From Baseline to End of Treatment (EOT) in Number of Micturitions Per 24 Hours||Baseline and EOT (Period 1-Week 8 and Period 2- Week 18)|"Full Analysis Set (FAS) consisted of all randomized participants who received at least 1 dose of double blind study drug and had filled out OAB-S tolerability scale at least once for a post baseline visit.
Last observation carried forward imputation (LOCF) was utilized."||Micturitions||Standard Error|Least Squares Mean
646807|NCT02138747|Secondary|Change From Baseline to End of Treatment (EOT) in Mean Number of Incontinence Episodes Per 24 Hours||Baseline and EOT (Period 1-Week 8 and Period 2- Week 18)|Full Analysis Set Incontinence (FAS I) consisted of all participants in the FAS who had at least 1 incontinence episode in the baseline 3-day micturition diary and at least 1 postbaseline diary during period 1.Last observation carried forward imputation (LOCF) was utilized.||Incontinence Episodes||Standard Error|Least Squares Mean
646808|NCT02138747|Secondary|Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Improvement in Day-to-Day Life Due to OAB Medication|Overall assessment of improvement in day-to-day life due to OAB medication was assessed on a scale from 1 to 5, with higher scores indicating greater improvement in day-to-day life due to current OAB medication.|Week 8 (End of Period 1) and Week 18 (End of Period 2)|Full Analysis Set (FAS) consisted of all randomized patients who received at least 1 dose of double blind study drug and had filled out OAB-S tolerability scale at least once for a postbaseline visit. Last observation carried forward imputation (LOCF) was utilized.||Units on a Scale||Standard Error|Mean
646809|NCT02138747|Secondary|Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Willingness to Continue OAB Medication|Overall assessment of willingness to continue OAB medication, was assessed on a scale from 1 to 5, with higher scores indicating greater desire to continue with current OAB medication.|Week 8 (End of Period 1) and Week 18 (End of Period 2)|Full Analysis Set (FAS) consisted of all randomized patients who received at least 1 dose of double blind study drug and had filled out OAB-S tolerability scale at least once for a postbaseline visit. Last observation carried forward imputation (LOCF) was utilized.||Units on a Scale||Standard Error|Mean
646810|NCT02138747|Secondary|Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Satisfaction With OAB Medication|Overall satisfaction with OAB medication was assessed on a scale of 1 to 5, with higher scores indicating greater satisfaction with current OAB medication.|Week 8 (End of Period 1) and Week 18 (End of Period 2)|Full Analysis Set (FAS) consisted of all randomized patients who received at least 1 dose of double blind study drug and had filled out OAB-S tolerability scale at least once for a postbaseline visit. Last observation carried forward imputation (LOCF) was utilized.||Units on a Scale||Standard Error|Mean
646811|NCT02138747|Secondary|Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Interruption of Day-to-Day Life Due to OAB|Overall assessment of interruption of day-to-day life due to OAB was assessed on a scale from 1 to 5, with higher scores indicating less interruption of day-to-day life due to OAB symptoms.|Week 8 (End of Period 1) and Week 18 (End of Period 2)|Full Analysis Set (FAS) consisted of all randomized patients who received at least 1 dose of double blind study drug and had filled out OAB-S tolerability scale at least once for a postbaseline visit. Last observation carried forward imputation (LOCF) was utilized.||Unit on a Scale||Standard Error|Mean
646812|NCT02138747|Secondary|Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Participant’s Fulfillment of OAB Medication Expectations|The final item score for overall assessment of patient’s fulfillment of OAB medication expectations ranged from 1 to 5, with higher scores indicating better fulfillment of OAB medication expectations.|Week 8 (End of Period 1) and Week 18 (End of Period 2)|Full Analysis Set (FAS) consisted of all randomized patients who received at least 1 dose of double blind study drug and had filled out OAB-S tolerability scale at least once for a postbaseline visit. Last observation carried forward imputation (LOCF) was utilized.||Units on a Scale||Standard Error|Mean
646813|NCT02138747|Secondary|Scale of the OAB-S Questionnaire at the End of Treatment Period: Satisfaction With OAB Control|Satisfaction with OAB control was scored from 0 to 100 with higher scores indicating greater satisfaction with OAB control.|Week 8 (End of Period 1) and Week 18 (End of Period 2)|Full Analysis Set (FAS) consisted of all randomized patients who received at least 1 dose of double blind study drug and had filled out OAB-S tolerability scale at least once for a postbaseline visit. Last observation carried forward imputation (LOCF) was utilized.||Units on a Scale||Standard Error|Mean
646814|NCT02138747|Secondary|Scale of the OAB-S Questionnaire at the End of Treatment Period: OAB Control|OAB control was scored from 0 to 100, with higher scores indicating better OAB control.|Week 8 (End of Period 1) and Week 18 (End of Period 2)|Full Analysis Set (FAS) consisted of all randomized patients who received at least 1 dose of double blind study drug and had filled out OAB-S tolerability scale at least once for a postbaseline visit. Last observation carried forward imputation (LOCF) was utilized.||Units on a Scale||Standard Error|Mean
646815|NCT02138747|Secondary|Scale of the OAB-S Questionnaire at the End of Treatment Period: Impact on Daily Living With OAB.|Impact on daily living with the OAB was scored from 0 to 100, with higher scores indicating greater satisfaction with ability to perform daily activities.|Week 8 (End of Period 1) and Week 18 (End of Period 2)|Full Analysis Set (FAS) consisted of all randomized patients who received at least 1 dose of double blind study drug and had filled out OAB-S tolerability scale at least once for a post baseline visit. Last observation carried forward imputation (LOCF) was utilized.||Units on a Scale||Standard Error|Mean
646816|NCT02138747|Secondary|Participants Preference Based on a 5-Point Scale at the End of Period 2 in Participants Who Completed at Least 14 Days of Study Drug in Both Study Treatment Periods.|"Participants were asked to choose which treatment period they preferred and the degree of preference. Preference was assessed on a 5-point scale assessed at the end of period 2 (“strong preference for period 1,” “mild preference for period 1,” “no preference,” “mild preference for period 2,” “strong preference for period 2”). Participants who selected either a “mild preference” or “strong preference” were considered as having a preference for a specific study drug and participants who selected “no preference” were considered as having no preference for one study drug over the other study drug."|Week 18 (End of Period 2)|Full Analysis Set (FAS-PNP [Preference/No Preference]) consisted of all randomized participant who took at least 14 days of double-blind study drug in each treatment period and had filled out the patient preference form.||Percentage of participants|||Number
646817|NCT02138747|Primary|Participants Tolerability Assessed by the Medication Tolerability Scale of the Overactive Bladder-Satisfaction (OAB-S) Questionnaire at the End of Treatment (EOT)|The medication tolerability scale measured the level of bothersomeness related to the occurrence of a side effect that was known to be related to the approved OAB medication (i.e., constipation, dry mouth, drowsiness, headache, nausea and blurred vision). The OAB medication tolerability score was calculated as a sum of the responses and converted to a scale from 0 to 100, where higher score indicates better perceived OAB medication tolerability (less bother from side-effects).|Week 8 (End of Period 1) and Week 18 (End of Period 2)|The Full Analysis Set (FAS) comprised of all randomized participants who received at least 1 dose of double blind study drug and had filled out OAB-S tolerability scale at least once for a postbaseline visit. Last observation carried forward imputation (LOCF) was utilized.||Units on a Scale||Standard Error|Least Squares Mean
646818|NCT02138461|Primary|Tolerability of Medications as Measured by the COMTOL Validated Instrument|Patients who are already taking the medications of interest will be enrolled from a general ophthalmology practice. Immediately after consenting to participate, they will complete a validated survey instrument called the Comparison of Ophthalmic Medication for Primary Outcome Measure Tolerability (COMTOL) questionnaire (Ophthalmology 1997; : 104:334-342). Because this study will not be a crossover trial design, and patients will only continue taking the medications they were prescribed in the course of their glaucoma therapy, the modified version will eliminate questions in the COMTOL related to subjective comparison of two medications and instead focus on tolerability of the single medication being taken by test subjects.|at the time of enrollment in the clinic, patients will immediately complete the questionnaire and exit the study|||percentage of patients|||Number
646819|NCT02138097|Secondary|Persistence at 12 Months for MarketScan Patients|Fraction of non-insulin hypoglycemic initiators with continued dispensing. Patients will be classified as persistent if they possess medication at 12 months. Grace period of 30 days will be allowed.|12 months|All patients in MarketScan cohort||Percentage of participants|||Number
646820|NCT02138097|Secondary|Persistence at 6 Months for MarketScan Patients|Fraction of non-insulin hypoglycemic initiators with continued dispensing. Patients will be classified as persistent if they possess medication at 6 months. Grace period of 30 days will be allowed.|6 months|All patients in MarketScan cohort||Percentage of participants|||Number
646821|NCT02138097|Secondary|Persistence at 3 Months for MarketScan Patients|Fraction of non-insulin hypoglycemic initiators with continued dispensing. Patients will be classified as persistent if they possess medication at 3 months. Grace period of 30 days will be allowed.|3 months|All patients in MarketScan cohort||Percentage of participants|||Number
646822|NCT02138097|Secondary|Persistence at 12 Months for United Healthcare Patients|Fraction of non-insulin hypoglycemic initiators with continued dispensing. Patients will be classified as persistent if they possess medication at 12 months. Grace period of 30 days will be allowed.|12 months|All patients in United Healthcare cohort||Percentage of participants|||Number
646823|NCT02138097|Secondary|Persistence at 6 Months for United Healthcare Patients|Fraction of non-insulin hypoglycemic initiators with continued dispensing. Patients will be classified as persistent if they possess medication at 6 months. Grace period of 30 days will be allowed.|6 months|All patients in United Healthcare cohort||Percentage of participants|||Number
650823|NCT02043379|Secondary|Respiratory Variables|Alive, ventilator free days will be recorded at hospital discharge.|until Hospital Discharge, an average of 30 days|||days||Inter-Quartile Range|Median
646828|NCT02138097|Secondary|Treatment Discontinuation for United Healthcare Patients|Number of patients with a treatment gap of >=6 months (i.e., no dispensing of non-insulin hypoglycemic agents within 6 months after the end of days supplied)|up to 12 months|All subjects in United Healthcare cohort||participants/1000 participant years|||Number
646829|NCT02138097|Primary|Subsequent Insulin Initiation for MarketScan Patients|Number of patients filling an insulin prescription subsequently to initiation of the original non-insulin agent without having filled one in the past 6 months|up to 12 months|All patients in MarketScan cohort||participants/1000 participant years|||Number
646830|NCT02138097|Primary|Subsequent Insulin Initiation for United Healthcare Patients|Number of patients filling an insulin prescription subsequently to initiation of the original non-insulin agent without having filled one in the past 6 months|up to 12 months|All patients in United Healthcare cohort||participants/1000 participant years|||Number
646831|NCT02138097|Primary|Treatment Augmentation for MarketScan Patients|Number of patients dispensing of a new non-insulin hypoglycemic agent while continuing to fill prescriptions for the initial therapy|up to 12 months|All patients in MarketScan cohort||participants/1000 participant years|||Number
646832|NCT02138097|Primary|Treatment Augmentation for United Healthcare Patients|Number of patients dispensing of a new non-insulin hypoglycemic agent while continuing to fill prescriptions for the initial therapy|up to 12 months|All patients in United Healthcare cohort||participants/1000 participant years|||Number
646833|NCT02138097|Primary|Treatment Switching for MarketScan Patients|Number of patients with dispensing of a new non-insulin hypoglycemic agent without subsequent to the end of days' supply of the original agent plus 30 days|up to 12 months|All subjects in MarketScan cohort||participants/1000 participant years|||Number
646834|NCT02138097|Primary|Treatment Switching for United Healthcare Patients|Number of patients with dispensing of a new non-insulin hypoglycemic agent without subsequent to the end of days' supply of the original agent plus 30 days|up to 12 months|All subjects in United Healthcare cohort||participants/1000 participant years|||Number
646835|NCT02138097|Primary|Proportion of Initiators for MarketScan Patients|Number of patients initiating each individual agent divided by the number of patients initiating any oral or non-insulin injected hypoglycemic agent.|up to 12 months|All subjects in MarketScan cohort||Percentage of participants|||Number
646836|NCT02138097|Primary|Proportion of Initiators for United Healthcare Patients|Number of patients initiating each individual agent divided by the number of patients initiating any oral or non-insulin injected hypoglycemic agent.|up to 12 months|All subjects in the United Healthcare cohort||Percentage of participants|||Number
646837|NCT02138006|Secondary|Morbidity of Cardiovascular Complications|Morbidity of: coronary heart disease, stroke and renal failure|Up to 28 years|||participants|||Number
646838|NCT02138006|Primary|Cardiovascular Mortality|All cause mortality and composite mortality from myocardial infarction, stroke and renal failure|Up to 28 years|||participants|||Number
646839|NCT02137785|Other Pre-specified|Oozing/Vesiculation/Crusting|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|12 Weeks after PDT #1|ITT||participants|||Number
646840|NCT02137785|Other Pre-specified|Oozing/Vesiculation/Crusting|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|8 Weeks after PDT #1|ITT||participants|||Number
646841|NCT02137785|Other Pre-specified|Oozing/Vesiculation/Crusting|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|4 Weeks after PDT #1|ITT||participants|||Number
646842|NCT02137785|Other Pre-specified|Oozing/Vesiculation/Crusting|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|2 Weeks after PDT #1|ITT||participants|||Number
646843|NCT02137785|Other Pre-specified|Oozing/Vesiculation/Crusting|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|24-48 hours after PDT #1|ITT||participants|||Number
646844|NCT02137785|Other Pre-specified|Oozing/Vesiculation/Crusting|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|Baseline|ITT||participants|||Number
653337|NCT01987453|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 24 Weeks|Safety Analysis Set||Percentage of participants|||Number
646845|NCT02137785|Other Pre-specified|Scaling & Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|12 Weeks after PDT #1|ITT||participants|||Number
646846|NCT02137785|Other Pre-specified|Scaling & Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|8 Weeks after PDT #1|ITT||participants|||Number
646847|NCT02137785|Other Pre-specified|Scaling & Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|4 Weeks after PDT #1|ITT||participants|||Number
646848|NCT02137785|Other Pre-specified|Scaling & Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|2 Weeks after PDT #1|ITT||participants|||Number
646849|NCT02137785|Other Pre-specified|Scaling & Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|24-48 hours after PDT #1|ITT||participants|||Number
646850|NCT02137785|Other Pre-specified|Scaling & Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Baseline|ITT||participants|||Number
646851|NCT02137785|Other Pre-specified|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|12 Weeks after PDT #1|ITT||participants|||Number
646852|NCT02137785|Other Pre-specified|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|8 Weeks after PDT #1|ITT||participants|||Number
646853|NCT02137785|Other Pre-specified|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|4 Weeks after PDT #1|ITT||participants|||Number
646854|NCT02137785|Other Pre-specified|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|2 Weeks after PDT #1|ITT||ITT|||Number
646855|NCT02137785|Other Pre-specified|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|24-48 Hours after PDT #1|ITT||participants|||Number
646856|NCT02137785|Other Pre-specified|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|5 minutes after PDT #1|ITT||participants|||Number
646857|NCT02137785|Other Pre-specified|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|During PDT #1|ITT||participants|||Number
646858|NCT02137785|Other Pre-specified|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|Baseline|ITT||participants|||Number
646859|NCT02137785|Other Pre-specified|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|12 Weeks after PDT #1|ITT||participants|||Number
646860|NCT02137785|Other Pre-specified|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|8 Weeks after PDT #1|ITT||participants|||Number
646861|NCT02137785|Other Pre-specified|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|4 Weeks after PDT #1|ITT||participants|||Number
646862|NCT02137785|Other Pre-specified|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|2 weeks after PDT #1|ITT||participants|||Number
646863|NCT02137785|Other Pre-specified|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|24-48 hours after PDT #1|ITT||participants|||Number
646864|NCT02137785|Other Pre-specified|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|5 minutes after PDT #1|ITT||participants|||Number
646865|NCT02137785|Other Pre-specified|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Baseline|ITT||participants|||Number
646866|NCT02137785|Other Pre-specified|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|12 Weeks after PDT #1|ITT||participants|||Number
646867|NCT02137785|Other Pre-specified|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|8 Weeks after PDT #1|ITT||participants|||Number
646868|NCT02137785|Other Pre-specified|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|4 Weeks after PDT #1|ITT||participants|||Number
646869|NCT02137785|Other Pre-specified|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|2 Weeks after PDT #1|ITT||participants|||Number
646870|NCT02137785|Other Pre-specified|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|24-48 hours after PDT #1|ITT||participants|||Number
646871|NCT02137785|Other Pre-specified|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|5 minutes after PDT #1|ITT||participants|||Number
646872|NCT02137785|Other Pre-specified|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Baseline|ITT||participants|||Number
646873|NCT02137785|Other Pre-specified|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|12 Weeks after PDT #1|ITT||participants|||Number
646874|NCT02137785|Other Pre-specified|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|8 Weeks after PDT #1|ITT||participants|||Number
646945|NCT02135900|Primary|Mean Oxygen Saturation (M SO2)|Assessment of M SO2 at baseline ( without heliox) and after 6-8 hours of sleep with heliox.|Baseline and in 6-8 hours.|Subjects with documented sleep apnea syndrome on nocturnal polysomnography||Percentage of oxygen saturation||95% Confidence Interval|Mean
646875|NCT02137785|Other Pre-specified|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|4 Weeks after PDT #1|ITT||participants|||Number
646876|NCT02137785|Other Pre-specified|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|2 Weeks after PDT #1|ITT||participants|||Number
646877|NCT02137785|Other Pre-specified|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|24-48 hours after PDT #1|ITT||participants|||Number
646878|NCT02137785|Other Pre-specified|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|Baseline|ITT||participants|||Number
646879|NCT02137785|Other Pre-specified|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|12 Weeks after PDT #1|ITT||participants|||Number
646880|NCT02137785|Other Pre-specified|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|8 Weeks after PDT #1|ITT||participants|||Number
646881|NCT02137785|Other Pre-specified|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|4 Weeks after PDT #1|ITT||participants|||Number
646882|NCT02137785|Other Pre-specified|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|2 Weeks after PDT #1|ITT||participants|||Number
646883|NCT02137785|Other Pre-specified|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|24-48 hours after PDT #1|ITT||participants|||Number
646884|NCT02137785|Other Pre-specified|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Baseline|ITT||participants|||Number
646885|NCT02137785|Secondary|Subject Satisfaction Score|"Subject satisfaction score
= Excellent (very satisfied)
= Good (moderately satisfied)
= Fair (slightly satisfied)
= Poor (not satisfied at all)"|Week 12|ITT||participants|||Number
646886|NCT02137785|Secondary|Complete Clearance Rate|proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area|Week 8|ITT||participants|||Number
646887|NCT02137785|Secondary|AK Clearance Rate|{1 - [(number of AK lesions at follow-up)/(number of AK lesions at Baseline)]} x 100|Baseline and Week 8|ITT using observed data only||percentage of baseline lesions cleared||Standard Deviation|Mean
646888|NCT02137785|Secondary|AK Clearance Rate|{1 - [(number of AK lesions at follow-up)/(number of AK lesions at Baseline)]} x 100|Baseline and Week 12|ITT using observed data only||percentage of baseline lesions cleared||Standard Deviation|Mean
646889|NCT02137785|Primary|Complete Clearance Rate|proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area|Week 12|ITT||participants|||Number
646890|NCT02137603|Secondary|Thirty Day Complication Rate|Superficial wound infection, deep organ space infection, ileus or bowel obstruction requiring hospitalization or re-operation|Thirty days|||participants|||Number
646891|NCT02137603|Primary|Post Operative Length of Stay||Post anesthesia care unit arrival to discharge home, an expected average of up to 48 hours|||Hours||Standard Deviation|Mean
646892|NCT02137512|Other Pre-specified|Reported Adverse Events|Reported adverse events during the 5-month extension phase.|Extension phase 5-month period||08/2016||||
646946|NCT02135900|Primary|Lowest Oxygen Saturation (L SO2)|Assessment of L SO2 at baseline ( without heliox) and after 6-8 hours of sleep with heliox.|Baseline and in 6-8 hours.|Subjects with documented sleep apnea syndrome on nocturnal polysomnography||Percentage of oxygen saturation||95% Confidence Interval|Mean
646893|NCT02137512|Other Pre-specified|Episodes of Severe Hypoglycemia Events|Episodes of severe hypoglycemia events during the 5-month extension phase defined as an event requiring assistance of another person due to altered consciousness to actively administer carbohydrate, glucagon, or other resuscitative actions. This means that the subject was impaired cognitively to the point that he/she was unable to treat him or herself, was unable to verbalize his or her needs, was incoherent, disoriented, and/or combative, or experienced seizure or coma. These episodes may be associated with sufficient neuroglycopenia to induce seizure or coma. If plasma glucose measurements are not available during such an event, neurological recovery attributable to the restoration of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration.|Extension phase 5-month period||08/2016||||
646894|NCT02137512|Other Pre-specified|Episodes of DKA Events|Episodes of DKA events that occurred during the 5-month extension phase.|Extension phase 5-month period||08/2016||||
646895|NCT02137512|Other Pre-specified|Glucose Coefficient of Variation (CV)|Glucose coefficient of variation in CGM measured glucose values over the course of the 5-month extension phase.|Extension phase 5-month period||08/2016||||
646896|NCT02137512|Other Pre-specified|Percentage of CGM Measured Glucose Values >300 mg/dL|Percentage of CGM measured glucose values >300 mg/dL in the 5-month extension phase of study system use at home in day+night closed-loop configuration.|Extension phase 5-month period||08/2016||||
646897|NCT02137512|Other Pre-specified|Percentage of CGM Measured Glucose Values >250 mg/dL|Percentage of CGM measured glucose values >250 mg/dL in the 5-month extension phase of study system use at home in day+night closed-loop configuration.|Extension phase 5-month period||08/2016||||
646898|NCT02137512|Other Pre-specified|Percentage of CGM Measured Glucose Values >180 mg/dL|Percentage of CGM measured glucose values >180 mg/dL in the 5-month extension phase of study system use at home in day+night closed-loop configuration.|Extension phase 5-month period||08/2016||||
646899|NCT02137512|Other Pre-specified|Percentage of CGM Measured Glucose Values 70-180 mg/dL|Percentage of CGM measured glucose values 70-180 mg/dL in the 5-month extension phase of study system use at home in day+night closed-loop configuration.|Extension phase 5-month period||08/2016||||
646900|NCT02137512|Other Pre-specified|Percentage of CGM Measured Glucose Values <70 mg/dL|Percentage of CGM measured glucose values <70 mg/dL in the 5-month extension phase of study system use at home in day+night closed-loop configuration.|Extension phase 5-month period||08/2016||||
646901|NCT02137512|Other Pre-specified|Percentage of CGM Measured Glucose Values <60 mg/dL|Percentage of CGM measured glucose values <60 mg/dL in the 5-month extension phase of study system use at home in day+night closed-loop configuration.|Extension phase 5-month period||08/2016||||
646902|NCT02137512|Other Pre-specified|Percentage of CGM Measured Glucose Values <50 mg/dL|Percentage of CGM measured glucose values <50 mg/dL in the 5-month extension phase of study system use at home in day+night closed-loop configuration.|Extension phase 5-month period||08/2016||||
646903|NCT02137512|Other Pre-specified|Mean CGM Sensor Glucose|Mean glucose during study system use at home during the extension phase in day+night closed-loop configuration|Extension phase 5-month period||08/2016||||
646904|NCT02137512|Other Pre-specified|Change in HbA1c|Comparison of HbA1c collected at baseline and at the end of the 5-month extension phase.|Extension phase 5-month period||08/2016||||
646905|NCT02137512|Secondary|High Blood Glucose Index (HBGI)|High blood glucose index (HBGI) in the 2 weeks of study system use at home in day+night closed-loop configuration when compared with the 2-weeks baseline sensor-augmented pump period. HBGI is a metric specifically designed to calculate the risk for hyperglycemia as reflected by blood glucose data. The HBGI is a non-negative quantity that increases when the number and/or extent of high blood glucose readings increases.|2-weeks|One participant was excluded due to missing baseline CGM data.||[ln(mg/dL)]^1.084||Inter-Quartile Range|Median
646906|NCT02137512|Secondary|Area Under the Curve (AUC) Glucose >180 mg/dL|Area under the Curve (AUC) glucose >180 mg/dL in the 2 weeks of study system use at home in day+night closed-loop configuration when compared with the 2-weeks baseline sensor-augmented pump period.|2-weeks|One participant was excluded due to missing baseline CGM data.||mg/dL * hours||Inter-Quartile Range|Median
646907|NCT02137512|Secondary|Percentage of Time CGM Measured Glucose Values >180 mg/dL|Percentage of time CGM measured glucose values >180 mg/dL in the 2 weeks of study system use at home in day+night closed-loop configuration when compared with the 2-weeks baseline sensor-augmented pump period.|2-weeks|One participant was excluded due to missing baseline CGM data.||percentage of sensor hours||Inter-Quartile Range|Median
646908|NCT02137512|Secondary|Percentage of Time CGM Measured Glucose Values >250 mg/dL|Percentage of time CGM measured glucose values >250 mg/dL in the 2 weeks of study system use at home in day+night closed-loop configuration when compared with the 2-weeks baseline sensor-augmented pump period.|2-weeks|One participant was excluded due to missing baseline CGM data.||percentage of sensor hours||Inter-Quartile Range|Median
646909|NCT02137512|Secondary|Low Blood Glucose Index (LBGI)|Low blood glucose index (LBGI) in the 2 weeks of study system use at home in day+night closed-loop configuration when compared with the 2-weeks baseline sensor-augmented pump period. LBGI is a metric specifically designed to calculate the risk for hypoglycemia as reflected by blood glucose data. The LBGI is a non-negative quantity that increases when the number and/or extent of low blood glucose readings increases.|2-weeks|One participant was excluded due to missing baseline CGM data.||[ln(mg/dL)]^1.084||Inter-Quartile Range|Median
646910|NCT02137512|Secondary|Area Under the Curve (AUC) Under 180 mg/dL|Area under the Curve (AUC) under 180 mg/dL in the 2 weeks of study system use at home in day+night closed-loop configuration when compared with the 2-weeks baseline sensor-augmented pump period.|2-weeks|One participant was excluded due to missing baseline CGM data||mg/dL * hours||Inter-Quartile Range|Median
646911|NCT02137512|Secondary|Percentage of Time CGM Measured Glucose Values <50 mg/dL|Percentage of time CGM measured glucose values <50 mg/dL in the 2 weeks of study system use at home in day+night closed-loop configuration when compared with the 2-weeks baseline sensor-augmented pump period.|2-weeks|One participant was excluded due to missing baseline CGM data.||percentage of sensor hours||Inter-Quartile Range|Median
646912|NCT02137512|Secondary|Percentage of Time CGM Measured Glucose Values <60 mg/dL|Percentage of time CGM measured glucose values <60 mg/dL in the 2 weeks of study system use at home in day+night closed-loop configuration when compared with the 2-weeks baseline sensor-augmented pump period.|2-weeks|One participant was excluded due to missing baseline CGM data||percentage of sensor hours||Inter-Quartile Range|Median
646913|NCT02137512|Secondary|Glucose Coefficient of Variation|Measure of CGM glucose variability in the 2 weeks of study system use at home in day+night closed-loop configuration when compared with the 2-weeks baseline sensor-augmented pump period.|2-weeks|One participant was excluded due to missing baseline CGM data.||percentage||Inter-Quartile Range|Median
646914|NCT02137512|Secondary|Percentage of Time Sensor Glucose Values 70 to 180 mg/dL|Percentage of time sensor glucose values 70 to 180 mg/dL during study system use at home in day+night closed-loop configuration when compared with the 2-weeks baseline sensor-augmented pump period.|2-weeks|One participant was excluded due to missing baseline CGM data||percentage of sensor hours||Inter-Quartile Range|Median
646915|NCT02137512|Secondary|Mean Glucose|Mean glucose during study system use at home in day+night closed-loop configuration when compared with the 2-weeks baseline sensor-augmented pump period.|2-weeks|One participant was excluded due to missing baseline CGM data.||mg/dl||Standard Deviation|Mean
646916|NCT02137512|Secondary|Time Spent in Hypoglycemia- Overnight Closed-loop Only|Percent median time spent with sensor glucose ≤70 mg/dl during study system use at home in closed-loop configuration at night only when compared with the 2-weeks baseline sensor-augmented pump period.|2-weeks|One participant was excluded due to missing baseline CGM data||percentage of hours||Inter-Quartile Range|Median
646917|NCT02137512|Primary|Time Spent in Hypoglycemia- 24 Hour Closed Loop|Percent median time spent with sensor glucose ≤70 mg/dl during study system use at home in day+night closed-loop configuration when compared with the 2-weeks baseline sensor-augmented pump period.|2-weeks|One participant was excluded due to missing baseline CGM data||percentage of hours||Inter-Quartile Range|Median
646918|NCT02137447|Secondary|Composite Secondary Outcomes of Non-infectious Abdominal Wound Complications, Damage to the Skin Caused by the Dressing, Need to End the Treatment Prior to Discharge or Prior to 5-7 Post-operative Days, and Need for Reapplication of the System.|"Secondary (composite) outcomes:
other non infectious abdominal wound complications,
damage to the skin caused by the dressing
need to end the treatment prior the discharge OR prior to 5 -7 post- operative days.
need for re-application of the system for any reason"|4 weeks|||Participants|||Count of Participants
646919|NCT02137447|Primary|Number of Participants With Surgical Site Infections Within 1 Month (4 Weeks ) From Index Operation|Incidence of SSIs within 1 month (4 weeks) from the index operation. SSI is defined by the Centers for Disease Control and Prevention's National Healthcare Surveillance Network|30 days|||Participants|||Count of Participants
646920|NCT02137382|Secondary|Percentage of Days With Formed/Normal Stools|The percentage of days with formed/normal stools is calculated from the diary during the treatment period: 100*(number of days with formed/normal stools/ number of days recorded in diary).|5 days|Per protocol||percentage of days||Standard Deviation|Mean
646921|NCT02137382|Secondary|Percentage of Days With no Abdominal Pain|The percentage of days with no abdominal pain is calculated from the diary during the treatment period: 100*(number of days with no abdominal pain/ number of days recorded in diary).|5 days|Per protocol||percentage of days||Standard Deviation|Mean
646922|NCT02137382|Secondary|Percentage of Days With no Flatulence|The percentage of days with no flatulence is calculated from the diary during the treatment period: 100*(number of days with no flatulence/number of days recorded in diary).|5 days|Per protocol||percentage of days||Standard Deviation|Mean
646923|NCT02137382|Secondary|Stool Frequency|Stool frequency is the average of the daily number of stools recorded during the treatment period|5 days|Per protocol||number of stools per day||Standard Deviation|Mean
646924|NCT02137382|Secondary|Total Fat Excretion|Total amount of fat excreted during the stool collection period in grams.|5 days|Per protocol||Grams||Standard Deviation|Mean
646925|NCT02137382|Secondary|Coefficient of Nitrogen Absorption (CNA).|CNA is calculated from nitrogen intake and nitrogen excretion, according to the formula: CNA (%) = 100 [nitrogen intake - nitrogen excretion] / nitrogen intake)|5 days|Per protocol||percentage of nitrogen intake||Standard Deviation|Mean
646926|NCT02137382|Primary|Coefficient of Fat Absorption (CFA)|CFA is calculated from fat intake and fat excretion, according to the formula: CFA (%) = 100 [fat intake - fat excretion] / fat intake|5 days|Per protocol||percentage of fat intake||Standard Deviation|Mean
646927|NCT02136498|Secondary|Number of Days of Varenicline Use|Number of days varenicline was used|5 mo follow-up|||Mean number of days||Standard Deviation|Mean
646928|NCT02136498|Primary|Point Prevalence Abstinence|Self-report of no-smoking, even a puff during the last 7 days.|5 month follow-up|Intent to treat analyses with missing cases imputed as smokers.||Percentage of people not smoking|||Number
646929|NCT02136238|Primary|Physical Function Performance 10 Test Score|Simulation of 10 activities of daily living (i.e. donning a shirt, sweeping, walking stairs). Measured in units of time, distance and mass to provide a singular, continuous scaled score of function (from 0-100). A score of 100 is the maximal score and indicates the highest level of independent function where a score of 0 indicates the poorest score. Persons scoring lower scores will likely be at increased risk of dependency with daily function.|Based on preliminary experience with the intervention, accommodation can range from 1 month to 2 months. Assessment was scheduled within 1-2 weeks following accommodation.|||units on a scale||Standard Deviation|Mean
646930|NCT02136238|Primary|Sternal Displacement During Towel Folding Task|Distance sternum is displaced while folding a towel was measured in meters.|Based on preliminary experience with the intervention, accommodation can range from 1 month to 2 months. Assessment was scheduled within 1-2 weeks following accommodation.|||meters||Standard Deviation|Mean
646931|NCT02136134|Secondary|Overall Survival (OS)|Overall Survival was measured from the date of randomization to the date of the participant's death.|Up to the end of the study (approximately of 3 years)|The intent-to-treat (ITT) population included all randomized participants.||months||95% Confidence Interval|Median
646932|NCT02136134|Secondary|Percentage of Participants With Negative Minimal Residual Disease (MRD)|The Minimal Residual Disease negativity rate was defined as the percentage of participants who had negative MRD assessment at any timepoint after the first dose of study drugs by evaluation of bone marrow aspirates or whole blood. MRD was assessed in participants who achieved complete response or stringent complete response (CR/sCR). IMWG criteria for CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and <5% PCs in bone marrow; sCR: CR plus normal FLC ratio, absence of clonal PCs by immunohistochemistry, immunofluorescence or 2 to 4 color flow cytometry.|Up to disease progression (approximately of 3 years)|The intent-to-treat (ITT) population included all randomized participants.||percentage of participants|||Number
646933|NCT02136134|Secondary|Overall Response Rate (ORR)|The Overall response rate was defined as the percentage of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) according to the International Myeloma Working Group (IMWG) criteria, during the study or during follow up. IMWG criteria for PR: >=50% reduction of serum M-protein and reduction in 24 hour urinary M-protein by >=90% or to <200 mg/24 hours, if the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria, in addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required.|Up to disease progression (approximately of 3 years)|The response-evaluable analysis set is defined as participants who have confirmed diagnosis of multiple myeloma and measurable disease at baseline or screening visit, received at least 1 administration of study treatment and had at least 1 post baseline disease assessment.||percentage of participants||95% Confidence Interval|Number
646934|NCT02136134|Secondary|Percentage of Participants With a Very Good Partial Response (VGPR) or Better|Response rate of VGPR or better was defined as the percentage of participants who achieved VGPR and CR (including sCR) according to the IMWG criteria during or after the study treatment. IMWG criteria for VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis, or >=90% reduction in serum M-protein plus urine M-protein <100 mg/24 hours, if the serum and urine M-protein are not measurable, a decrease of >90% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria, in addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required; CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and <5% PCs in bone marrow; sCR: CR and normal FLC ratio, absence of clonal PCs by immunohistochemistry, immunofluorescence or 2 to 4 color flow cytometry.|Up to disease progression (approximately of 3 years)|The response evaluable analysis set is defined as participants who have a confirmed diagnosis of multiple myeloma and measurable disease at baseline or screening visit, received at least 1 administration of study treatment, and had at least 1 post baseline disease assessment.||percentage of participants||95% Confidence Interval|Number
646935|NCT02136134|Secondary|Time to Disease Progression (TTP)|TTP was defined as time from date of randomization to date of first documented evidence of progressive disease (PD). PD was defined as meeting any one of following criteria: Increase of >=25% in level of serum M-protein from lowest response value and absolute increase must be >=0.5 g/dL; Increase of >=25% in 24-hour urinary light chain excretion (urine M-protein) from lowest response value and absolute increase must be >=200 mg/24hours; Only in participants without measurable serum and urine M-protein levels: increase of >=25% in difference between involved and uninvolved free light chain (FLC) levels from lowest response value and absolute increase must be >10 milligram per deciliter (mg/dL); Definite increase in size of existing bone lesions or soft tissue plasmacytomas; Definite development of new bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to Plasma Cell (PC) proliferative disorder.|From the date of randomization to the date of first documented evidence of progression or death due to PD whichever occurs first (approximately 3 years)|The intent-to-treat (ITT) population included all randomized participants.||months||95% Confidence Interval|Median
646936|NCT02136134|Primary|Progression-free Survival (PFS)|PFS was defined as duration from date of randomization to either progressive disease (PD)/death, whichever occurred first. PD was defined as meeting any one of following criteria: Increase of greater than equal to (>=)25 percent (%) in level of serum M-protein from lowest response value and absolute increase must be >=0.5 gram per deciliter (g/dL); Increase of >=25% in 24-hour urinary light chain excretion (urine M-protein) from lowest response value and absolute increase must be >=200 mg/24hours; Only in participants without measurable serum and urine M-protein levels: increase of >=25% in difference between involved and uninvolved FLC levels from lowest response value and absolute increase must be >10 mg/dL; Definite increase in size of existing bone lesions or soft tissue plasmacytomas; Definite development of new bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to PC proliferative disorder.|From the date of randomization to either progressive disease or death, whichever occurs first (approximately 3 years)|The intent-to-treat (ITT) population included all randomized participants.||months||95% Confidence Interval|Median
647028|NCT02133781|Primary|Number of Participants From Each Arm Who Received Influenza Vaccine||Day 0 to 28|||Participants|||Count of Participants
646947|NCT02135900|Primary|Apnea Index (AI)|Assessment of Apnea Index (AI) at baseline ( without heliox) and after 6-8 hours of sleep with heliox.|Baseline and in 6-8 hours. The reported data are at baseline ( without heliox) and after 6-8 hours of sleep with heliox.|Subjects with documented sleep apnea syndrome on nocturnal polysomnography||Number of apneas per hour sleep||95% Confidence Interval|Mean
646948|NCT02135900|Primary|Apnea Hypopnea Index|Assessment of Apnea/Hypopnea Index (AHI) at baseline ( without heliox) and after 6-8 hours of sleep with heliox.|Baseline and in 6-8 hours. The reported data are at baseline ( without heliox) and after 6-8 hours of sleep with heliox.|Subjects with documented sleep apnea syndrome on nocturnal polysomnography||Apneas or hypopneas per hour sleep||95% Confidence Interval|Mean
646949|NCT02135445|Secondary|Change From Baseline in 25-item Prostate Cancer-specific Questionnaire Supplement (EORTC QLQ-PR25) Score|EORTC QLQ-PR25 : EORTC module designed to supplement the QLQ-C30 for any application in prostate cancer. It Consist of 25 questions distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Questions used 4 point scale (1 'Not at all' to 4 'Very much'). All raw domain scores are linearly transformed to a 0-100 scale, with higher scores reflecting either more symptoms (urinary, bowel, hormonal treatment-related symptoms) or higher levels of activity or functioning (sexual).|Baseline and last post-baseline value up to Week 37|Safety population where baseline and post-baseline assessments were available. Safety population included all participants who received at least one dose of study medication.||units on scale||Standard Error|Least Squares Mean
646950|NCT02135445|Secondary|Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Score|EORTC QLQ-C30 included 30 questions comprising 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, nausea/vomiting), single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties) and a global health and QOL scale. Most questions used 4 point scale (1 'Not at all' to 4 'Very much'); 2 questions used 7-point scale (1 'Very poor' to 7 'Excellent'). All domain scores were calculated as an average of item scores and transformed to 0-100 score range where a high score from 0-100 indicates: A high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status/quality of life (QoL) represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problem.|Baseline and last post-baseline value up to Week 37|Safety population where baseline and post-baseline assessments were available. Safety population included all participants who received at least one dose of study medication.||units on scale||Standard Error|Least Squares Mean
646951|NCT02135445|Secondary|Percent Change From Baseline in Aging Male's Symptoms (AMS) Total Scale Score|AMS scale is a self-administered questionnaire used to 1) assess symptoms of aging (independent from those that are disease related) between groups of males under different conditions; 2) evaluate the severity of symptoms over time; and 3) measure changes before and after androgen therapy. Each question was answered between none (1) to extremely severe (5) for 17 items from psychological (5 items), somatic (7 items), and sexual (5 items) categories. Total score is sum of all the item scores and range from 17 (minimum) to 85 (maximum), where high score indicated high level of symptoms.|Day 1 of Weeks 5, 13, 25, 29, 33 and 37|Safety population where baseline and post-baseline assessments were available. Safety population included all participants who received at least one dose of study medication.||percent change||Standard Deviation|Mean
646952|NCT02135445|Secondary|Serum Sex Hormone-Binding Globulin (SHBG) Level||Baseline, Day 1 of Week 2, 5, 13, 25 and 29|Safety population where baseline and post-baseline assessments were available. Safety population included all participants who received at least one dose of study medication.||nmol/L||Standard Deviation|Mean
646953|NCT02135445|Secondary|Serum Follicle-Stimulating Hormone (FSH) Level||Baseline, Day 1 of Week 2, 5, 13, 25 and 29|Safety population where baseline and post-baseline assessments were available. Safety population included all participants who received at least one dose of study medication.||International units per liter (IU/L)||Standard Deviation|Mean
646954|NCT02135445|Secondary|Serum Luteinizing Hormone (LH) Level||Baseline, Day 1 of Weeks 2, 3, 5, 9, 13, 17, 21, 25, 29, and 37|Safety population where baseline and post-baseline assessments were available. Safety population included all participants who received at least one dose of study medication.||milli-international units per milliliter||Standard Deviation|Mean
646955|NCT02135445|Secondary|Plasma Concentrations of TAK-385||Day 1 Week 1, 2, 3, 5, 9, 13, 17, 25, 33, 37: Pre-dose; Day 1 Week 5, 13: 2 hrs Post-dose; Day 4 Week 1: Pre-dose|Safety population where TAK-385 assessments were available. Safety population included all participants who received at least one dose of study medication.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
646956|NCT02135445|Secondary|Serum PSA Concentration||Day 1 of Week 13, 25, 29, 33 and 37|Safety population where baseline and post-baseline assessments were available. Safety population included all participants who received at least one dose of study medication.||mcg/L||Standard Deviation|Mean
646957|NCT02135445|Secondary|PSA Nadir||Baseline up to Day 1 Week 25|Safety population included all participants who received at least one dose of study medication.||microgram per liter (mcg/L)||Standard Deviation|Mean
646958|NCT02135445|Secondary|Percent Change From Baseline in Serum PSA Concentration||Baseline, Day 1 of Week 2, 3 , 5, 9, 13, 17, 21, 25, 29, 33 and 37|Safety population where baseline and post-baseline assessments were available. Safety population included all participants who received at least one dose of study medication.||percent change||Standard Deviation|Mean
646959|NCT02135445|Secondary|Number of Participants With PSA Response of >=50% and >=90% Reduction|Prostate-specific Antigen (PSA) response was defined as 50% and 90% reduction from baseline in serum PSA levels.|Day 1 Week 13|Safety population included all participants who received at least one dose of study medication.||participants|||Number
646960|NCT02135445|Secondary|Percentage of Participants Who Have Recovered to >280 ng/dL Testosterone||Day 1 Week 25 up to Day 1 Week 37|Safety population included all participants who received at least one dose of study medication.||percentage of participants|||Number
646961|NCT02135445|Secondary|Percentage of Participants Who Have Recovered to Baseline Value of Testosterone||Up to Day 1 Week 37|Safety population included all participants who received at least one dose of study medication.||percentage of participants|||Number
650034|NCT02062905|Secondary|Conjunctival Redness|"Proprietary Ora Calibra Ocular Hyperemia Scale (0 - 4 with 0.5 unit increments allowed; 0 = no redness)"|14 days post insertion|||units on a scale (0 - 4)||Standard Deviation|Mean
646962|NCT02135445|Secondary|Estimated Time to Testosterone Recovery (TTR)|TTR is defined as the time from 1 day after the last dose of TAK-385 or 4 weeks plus 1 day after the last dose of degarelix to testosterone recovery. Testosterone recovery is defined as back to baseline or >280 ng/dL whichever occurs first. TTR was determined during 12 weeks after the discontinuation of androgen deprivation therapy (ADT).|Up to Day 1 Week 37|Safety population included all participants who received at least one dose of study medication.||days||95% Confidence Interval|Median
646963|NCT02135445|Secondary|Time to Achieve Profound Castration|Time to profound castration is defined as days from first dose to first testosterone measurement that is <20 ng/dL.|Baseline up to Week 37|Safety population included all participants who received at least one dose of study medication.||days||95% Confidence Interval|Median
646964|NCT02135445|Secondary|Time to Achieve Effective Castration|Time to effective castration is defined as days from first dose to first testosterone measurement that is <50 ng/dL.|Baseline up to Week 37|Safety population included all participants who received at least one dose of study medication.||days||95% Confidence Interval|Median
646965|NCT02135445|Secondary|Average Percent Change in Prostate Size|Percent change in prostate size was assessed at a follow up visit between Day 1 Week 9 to Day 1 Week 13.|Baseline, Day 1 Week 9 to Day 1 Week 13|Safety population where baseline and post-baseline assessments were available. Safety population included all participants who received at least one dose of study medication.||percent change||Standard Deviation|Mean
646966|NCT02135445|Secondary|Number of Participants Reporting One or More TEAEs and Serious Adverse Events (SAEs)||Baseline up to Week 29|Safety population included all participants who received at least one dose of study medication.||participants|||Number
646967|NCT02135445|Secondary|Number of Participants With TEAEs Categorized Into Investigations Related to Chemistry, Hematology or Urinalysis||Baseline up to Week 29|Safety population included all participants who received at least one dose of study medication.||participants|||Number
646968|NCT02135445|Secondary|Number of Participants With TEAEs Related to 12-lead Electrocardiogram (ECG) Findings||Baseline up to Week 29|Safety population included all participants who received at least one dose of study medication.||participants|||Number
646969|NCT02135445|Secondary|Number of Participants With TEAEs Related to Physical Findings||Baseline up to Week 29|Safety population included all participants who received at least one dose of study medication.||participants|||Number
646970|NCT02135445|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Vital Signs||Baseline up to Week 29|Safety population included all participants who received at least one dose of study medication.||participants|||Number
646971|NCT02135445|Primary|Percentage of Participants With Effective Castration Rate Over 25 Weeks|Castration rate is defined as the observed percentage of participants who have testosterone concentrations less than (<) 50 nanogram per deciliter (ng/dL) (1.73 nanomole per liter [nmol/L]) at all scheduled visits.|Day 1 Week 5 up to Day 1 Week 25|Safety population included all participants who received at least one dose of study medication.||percentage of participants||95% Confidence Interval|Number
646972|NCT02135432|Other Pre-specified|Pharmacokinetics as Described by AUC12 of Subjects Receiving Ivacaftor||baseline to 2 weeks||||||
646973|NCT02135432|Secondary|Change in COPD as Measured by Change in Percentage of FEV1 as Measured in Each Group|Spirometry will be analyzed by ATS criteria, and the best of three reproducible efforts will be used to calculate FEV1 in comparison to Hankinson standards. The primary analysis will be the change in FEV1% from day 0 to day 14 within subject, and will be tested against the null hypothesis that no change occurs using a paired t-test unless the distributions are notably skewed, in which case the non-parametric Wilcoxon signed-rank test will be implemented due to small sample size.|baseline to 2 weeks|||percentage of FEV1||Standard Deviation|Mean
646974|NCT02135432|Secondary|Number of Adverse Events Experienced by the Ivacaftor Subjects and Placebo Subjects.|Number of adverse events per subject in each the Ivacaftor subjects and placebo subjects|baseline to 2 weeks|||adverse events|||Number
646975|NCT02135432|Secondary|Change in COPD as Measured by Nasal Potential Difference|Evaluate the efficacy of ivacaftor treatment in patients with COPD including measures of CFTR activity and clinical outcome as measured by change in nasal potential difference measurement in each group. These data will be used to test the null hypothesis of no change in nasal potential difference (ΔLow Chloride plus isoproterenol) using a paired t-test unless the distributions are notably skewed, in which case the non-parametric Wilcoxon signed-rank test will be implemented due to small sample size.|baseline to 2 weeks|||millivolts||Standard Deviation|Mean
646976|NCT02135432|Primary|Change in COPD as Measured by the Sweat Analysis in Each Group|sweat analysis is measured by performing a sweat test in each participant. The primary analysis will compare the within group change in sweat chloride before (day 1) and after (day 14) ivacaftor or placebo administration and will be used to test the null hypothesis of no change in sweat chloride using a paired t-test unless the distributions are notably skewed, in which case the non-parametric Wilcoxon signed-rank test will be implemented due to small sample size.|baseline to 2 weeks|8 patients were analyzed in the ivacaftor Arm because 8 patients were randomized to study drug and only 4 patients were randomized in the placebo arm because 4 patients received placebl||mmol/L||Standard Deviation|Mean
646977|NCT02135016|Secondary|The Block Level of Epidural Anesthesia|The block level 20mins after epidural anesthesia and it is verified by the loss of sensation to alcohol swab before target controlled infusion of propofol.It is the number of block segments.The block level varies from 0 to 10(0, no block level; 1 to 5, narrow block level;6 to 10, wide block level).|20 mins after epidural anesthesia|||units on a scale||Standard Deviation|Mean
646978|NCT02135016|Secondary|The Heart Rate|The heart rate of each patient will be recorded at three different four points, as follows, baseline(the awake phase before epidural anesthesia), 10mins after epidural anesthesia, 20 mins after epidural anesthesia, loss of consciousness(when the participants are lost eyelash reflex during propofol TCI induction of anesthesia).|The participants will be followed for the duration of anesthesia induction, an expected average of half an hour|||beats per minute||Standard Deviation|Mean
646979|NCT02135016|Secondary|The Mean Blood Pressure|The mean arterial pressure of each patient will be recorded at four different time points, as follows, baseline(the awake phase before epidural anesthesia), 10 mins after epidural anesthesia, 20 mins after epidural anesthesia, loss of consciousness(when the participants are lost eyelash reflex during propofol TCI induction of anesthesia).|The participants will be followed for the duration of anesthesia induction, an expected average of half an hour|||mmHg||Standard Deviation|Mean
646980|NCT02135016|Secondary|The Bispectral Index|The bispectral index (BIS) of each patient will be recorded at four different time points,as follows, baseline(the awake phase before epidural anesthesia),10 mins after epidural anesthesia, 20 mins after epidural anesthesia, loss of consciousness(when the participants are lost eyelash reflex during propofol TCI induction of anesthesia). BIS values varies from 0 to 100(0, no cerebral activity; 40 to 60, general anesthesia; 60 to 85, sedated; 85 to 100, awake).|The participants will be followed for the duration of anesthesia induction, an expected average of half an hour|||units on a scale||Standard Deviation|Mean
646981|NCT02135016|Primary|The Effect-site Concentration of Propofol|The effect-site concentration of propofol when loss of consciousness during propofol target-controlled infusing(TCI) induction of anesthesia.|The participants will be followed for the duration of anesthesia induction, an expected average of half an hour|||µg/ml||Standard Deviation|Mean
646982|NCT02134977|Secondary|Number of Participants Reporting One or More Serious Adverse Drug Reactions|Serious adverse drug reactions are defined as serious adverse events (SAE) which are in the investigator’s opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The event was occurred in breast cancer female.|Baseline up to Week 48|Safety analysis set was defined as participants who received at least one dose of study medication.||participants|||Number
646983|NCT02134977|Secondary|Number of Participants Reporting One or More Adverse Drug Reactions|Adverse drug reactions are defined as adverse events (AE) which are in the investigator’s opinion of causal relationship to the study treatment. AE are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.|Baseline up to Week 48|Safety analysis set was defined as participants who received at least one dose of study medication.||participants|||Number
646984|NCT02134977|Secondary|Percentage of Participants With Positive Change in Agents|"The question was with regard to the assessment of convenience associated with the changes in agents, Was the change in agents good? and the options of the answers were very good, somewhat good, whether or not the change in agents was good cannot be determined, somewhat bad, very bad."|Week 48|Efficacy assessment population where Week 48 assessment for convenience assessment were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.||percentage of participants|||Number
646985|NCT02134977|Secondary|Percentage of Participants With Change in Pain at the Time of Injection Due to the Change in Medicinal Agents|"The question was with regard to the assessment of convenience associated with the changes in agents, Was there a change in pain at the time of injection due to the change in agents? and the options of the answers were significantly relieved, slightly relieved, whether or not the pain worsened or was relieved cannot be determined, worsened slightly, and worsened significantly."|Week 48|Efficacy assessment population where Week 48 assessment for convenience assessment were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.||percentage of participants|||Number
646986|NCT02134977|Secondary|Percentage of Participants With Change in Adverse Drug Reactions Due to the Change in Medicinal Agents|"The question was with regard to the assessment of convenience associated with the changes in agents, Was there a change in adverse drug reactions (e.g., menopausal-like symptoms such as hot flushes, injection-site abnormalities) due to the change in agents? and the options of the answers were events became much less severe, events became less severe, whether or not the events became severe cannot be determined, events became slightly more severe, and events became very severe."|Week 48|Efficacy assessment population where Week 48 assessment for convenience assessment were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.||percentage of participants|||Number
646987|NCT02134977|Secondary|Percentage of Participants Who Worried About the Effect of the Medicinal Agent|"The question was with regard to the assessment of convenience associated with the changes in agents, The change in agents reduced the frequency of injections by one third; for this reason, did you worry about the effect? and the options of the answers were not at all worried, not too worried, no thought either way, somewhat worried, and very worried."|Week 48|Efficacy assessment population where Week 48 assessment for convenience assessment were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.||percentage of participants|||Number
646988|NCT02134977|Secondary|Percentage of Participants With Relief From Financial Burden Due to the Change in Medicinal Agents|"The question was with regard to the assessment of convenience associated with the changes in agents, Did you feel relief from financial burden (example, 3 months’ drug costs and transportation fee) due to the change in agents? and the answers were categorized as felt extreme relief, felt slight relief, no feeling either way, felt little relief, felt no relief. The sum of all the categories is not 100% because of rounding error."|Week 48|Efficacy assessment population where Week 48 assessment for convenience assessment were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.||percentage of participants|||Number
646989|NCT02134977|Secondary|Percentage of Participants Who Felt Relief From Physical and Emotional Burden|"The question was with regard to the assessment of convenience associated with the changes in agents, The change in agents reduced the frequency of injections by one third; for this reason, did you feel relief from physical and emotional burden? and the answers were categorized as felt extreme relief, felt slight relief, no feeling either way, felt little relief, felt no relief."|Week 48|Efficacy assessment population where Week 48 assessment for convenience assessment were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.||percentage of participants|||Number
647029|NCT02133664|Primary|Controlled Oral Word Association Test (COWAT)|The COWAT is a letter fluency test. Participants are asked to generate as many words as possible beginning with a particular letter of the alphabet during one minute. Alternate versions using 3 letters are used for each examination. The change in total number of words produced for the 3 letters from baseline to 12 weeks will be the outcome.|baseline to 12 weeks|Only participant who completed COWAT at both baseline and 12 weeks were analyzed||words||Standard Deviation|Mean
646990|NCT02134977|Secondary|Percentage of Participants With Reduction in Frequency of Medical Visits Due to Change in Medicinal Agents|"The question was with regard to the assessment of convenience associated with the changes in agents, Did the change in agents reduce the frequency of your medical visits? and the answers were categorized as very much reduced, somewhat reduced, unchanged. Change in medicinal agents means participants with a historical diagnosis of premenopausal breast cancer who switched to leuprorelin acetate sustained-release 11.25 mg injection kit from a 4-week adjuvant therapy with a LH-RHa 1 month depot preparation as part of daily medical practice."|Week 48|Efficacy assessment population where Week 48 assessment for convenience assessment were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.||percentage of participants|||Number
646991|NCT02134977|Primary|Score of QOL-ACD-B Items 19, 20 and 21 at Week 48|QOL-ACD-B is a part of QOL-ACD (using questionnaire items 1 to 18). For questionnaire item 19 (Did you feel inferior to your child when you interact with him/her? [due to the impact of illness and treatment]), item 20 (Did you worry about child rearing? [due to the impact of illness and treatment]), and item 21 (Do you worry about pregnancy or delivery? [due to the impact of illness and treatment]), the calculation was based on the score of each item. Each item was scored on a 5-point scale, where 1 was the worst response and 5 was the best.|Week 48|Efficacy assessment population where Week 48 assessment for each item were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.||units on a scale||Standard Deviation|Mean
646992|NCT02134977|Primary|Score of QOL-ACD-B Items 19, 20 and 21 at Week 12|QOL-ACD-B is a part of QOL-ACD (using questionnaire items 1 to 18). For questionnaire item 19 (Did you feel inferior to your child when you interact with him/her? [due to the impact of illness and treatment]), item 20 (Did you worry about child rearing? [due to the impact of illness and treatment]), and item 21 (Do you worry about pregnancy or delivery? [due to the impact of illness and treatment]), the calculation was based on the score of each item. Each item was scored on a 5-point scale, where 1 was the worst response and 5 was the best.|Week 12|Efficacy assessment population where Week 12 assessment for each item were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.||units on a scale||Standard Deviation|Mean
646993|NCT02134977|Primary|Score of QOL-ACD-B Items 19, 20 and 21 at Baseline|QOL-ACD-B is a part of QOL-ACD (using questionnaire items 1 to 18). For questionnaire item 19 (Did you feel inferior to your child when you interact with him/her? [due to the impact of illness and treatment]), item 20 (Did you worry about child rearing? [due to the impact of illness and treatment]), and item 21 (Do you worry about pregnancy or delivery? [due to the impact of illness and treatment]), the calculation was based on the score of each item. Each item was scored on a 5-point scale, where 1 was the worst response and 5 was the best.|Baseline|Efficacy assessment population where baseline assessment for each item were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.||units on a scale||Standard Deviation|Mean
646994|NCT02134977|Primary|Score of QOL-ACD-B at Week 48|QOL-ACD-B is a part of QOL-ACD (using questionnaire items 1 to 18). QOL-ACD is a score used for cancer participants treated with anti-cancer drug and is a 22-item self-reported instrument assessing differences in symptom severity and health-related QOL. Participants answer each question on a 5-point scale (1: not at all [worst response] to 5: very much [best response]). Total score for QOL-ACD-B is calculated as a sum of 18 items, score range: 18 to 90 where less scores reflect greater symptom severity and symptom impact on health-related quality of life. Means and standard deviations were calculated for the total score and score of each subscale from questionnaire items 1 to 18.|Week 48|Efficacy assessment population where Week 48 assessment for total and subscale scores were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.||units on a scale||Standard Deviation|Mean
646995|NCT02134977|Primary|Score of QOL-ACD-B at Week 12|QOL-ACD-B is a part of QOL-ACD (using questionnaire items 1 to 18). QOL-ACD is a score used for cancer participants treated with anti-cancer drug and is a 22-item self-reported instrument assessing differences in symptom severity and health-related QOL. Participants answer each question on a 5-point scale (1: not at all [worst response] to 5: very much [best response]). Total score for QOL-ACD-B is calculated as a sum of 18 items, score range: 18 to 90 where less scores reflect greater symptom severity and symptom impact on health-related quality of life. Means and standard deviations were calculated for the total score and score of each subscale from questionnaire items 1 to 18.|Week 12|Efficacy assessment population where Week 12 assessment for total and subscale scores were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.||units on a scale||Standard Deviation|Mean
646996|NCT02134977|Primary|QOL-ACD Breast (QOL-ACD-B) Score at Baseline|QOL-ACD-B is a part of QOL-ACD (using questionnaire items 1 to 18). QOL-ACD is a score used for cancer participants treated with anti-cancer drug and is a 22-item self-reported instrument assessing differences in symptom severity and health-related QOL. Participants answer each question on a 5-point scale (1: not at all [worst response] to 5: very much [best response]). Total score was calculated over score range 0-100 for item 1 to 18 as ((a sum of 18 items)/18-1)*25). Score for physical condition and pain was calculated over score range 0-100 for item 1 to 6 as ((a sum of 6 items)/6-1)*25)). Score for health-care and illness satisfaction was calculated over score range 0-100 for item 7 to 10 as ((a sum of 4 items)/4-1)*25)), where less scores reflect greater symptom severity and symptom impact on health-related quality of life. Means and standard deviations were calculated for the total score and score of each subscale from questionnaire items 1 to 18.|Baseline|Efficacy assessment population where baseline assessment for total and subscale scores were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.||units on a scale||Standard Deviation|Mean
647030|NCT02133664|Primary|California Verbal Learning Test-II (CVLT-II)|"CVLT-II is a measure of verbal learning/memory. It is comprised of lists containing 16 words, each of which fit into one of four categories of shopping list items. Five trials are administered followed by presentation of a different list. Free and cued recall of the original list is assessed. The change in long delay free recall from baseline to 12 weeks will be the measurement used for outcome."|baseline to 12 weeks|Only participants who completed CVLT-II at baseline and 12 weeks were analyzed||correct responses||Standard Deviation|Mean
646997|NCT02134977|Primary|QOL-ACD Total and Subscale Score at Week 48|QOL-ACD score is a score used for cancer participants treated with anti-cancer drug and is a 22-item self-reported instrument assessing differences in symptom severity and health-related QOL. It includes 4 subscale domains: Daily Activities, Physical Condition, Social Activities, Mental and Psychological Status. Total and subscale scores are calculated as sum of items within each subscale: Daily Activity (items 1-6), Physical Condition (7-11), Psychological Condition (12-16), Social Attitude (17-21) and total (1-22). Face scale: 5-point score for 1 item (22). Participants answer each question on a 5-point scale (1: not at all [worst response] to 5: very much [best response]). Score range for total score is 22 to 110 and subscale score range for daily activity is 6 to 30, and for physical condition, psychological condition, and social attitude is 5 to 25. Less total/subscale scores reflect greater symptom severity and symptom impact on health-related QOL.|Week 48|Efficacy assessment population where Week 48 assessment for total and subscale scores were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.||units on a scale||Standard Deviation|Mean
646998|NCT02134977|Primary|QOL-ACD Total and Subscale Score at Week 12|QOL-ACD score is a score used for cancer participants treated with anti-cancer drug and is a 22-item self-reported instrument assessing differences in symptom severity and health-related QOL. It includes 4 subscale domains: Daily Activities, Physical Condition, Social Activities, Mental and Psychological Status. Total and subscale scores are calculated as sum of items within each subscale: Daily Activity (items 1-6), Physical Condition (7-11), Psychological Condition (12-16), Social Attitude (17-21) and total (1-22). Face scale:5-point score for 1 item (22). Participants answer each question on a 5-point scale (1: not at all [worst response] to 5: very much [best response]). Score range for total score is 22 to 110 and subscale score range for daily activity is 6 to 30, and for physical condition, psychological condition, and social attitude is 5 to 25. Less total/subscale scores reflect greater symptom severity and symptom impact on health-related QOL.|Week 12|Efficacy assessment population where Week 12 assessment for total and subscale scores were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.||units on a scale||Standard Deviation|Mean
646999|NCT02134977|Primary|Quality of Life Questionnaire for Cancer Patients Treated With Anticancer Drugs (QOL-ACD) Total and Subscale Score at Baseline|QOL-ACD score is a score used for cancer participants treated with anti-cancer drug and is a 22-item self-reported instrument assessing differences in symptom severity and health-related QOL. It includes 4 subscale domains: Daily Activities, Physical Condition, Social Activities, Mental and Psychological Status. Total and subscale scores are calculated as sum of items within each subscale: Daily Activity (items 1-6), Physical Condition (7-11), Psychological Condition (12-16), Social Attitude (17-21) and total (1-22). Face scale: 5-point score for 1 item (22). Participants answer each question on a 5-point scale (1: not at all [worst response] to 5: very much [best response]). Score range for total score is 22 to 110 and subscale score range for daily activity is 6 to 30, and for physical condition, psychological condition, and social attitude is 5 to 25. Less total/subscale scores reflect greater symptom severity and symptom impact on health-related QOL.|Baseline|Efficacy assessment population where baseline assessment for total and subscale scores were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.||units on a scale||Standard Deviation|Mean
647000|NCT02134717|Secondary|Chemokine Receptor 5 (CCR5) Expression Among These Immune Effector Cells|CCR5 expression among these immune effector cells before and after CCR5 inhibition. Measure was not performed be cause study was terminated before this measure was performed.|6 weeks||||||
647001|NCT02134717|Secondary|Mononuclear Cell (MNC) Activation and T-cell Differentiation|MNC activation and T-cell differentiation before and after CCR5 inhibition. Data was not collected because study was terminated before these analyses were performed.|6 weeks||||||
647002|NCT02134717|Primary|Total Cell Count and Differentials in Blood and Bronchoalveolar Lavage Fluid Pre- and Post Maraviroc|General indicators of inflammation following chemokine receptor 5 (CCR5) inhibition in blood and bronchoalveolar lavage|6 weeks|Data could not be analyzed|||||
647003|NCT02134587|Secondary|Quality of ADE Reports|Skills evaluation will be carried out according to the perception of the voluntary regarding the relevance´s degree of the information to be filled in ADE form. Therefore, in the first (prior to educational intervention) and fourth (post-educational intervention period) meetings, subjects will be asked to highlight the fields of ADE form, according to unnecessary, necessary or essential information to be reported. Minimal and desirable criteria to be filled in ADE form preconized by Pan-American Health Organization will be considered gold-standard answers. Scores from zero to ten will be assigned, according to gold-standard answers. Data will be compared, in order to estimate the impact of educational intervention on skills to fill ADE form.|Two days|The subjects were assessed regarding pharmacovigilance´s skills prior to educational interventions and after as well, in order to evaluate the effectiveness of the study in contribute on the improvement of the quality of information inserted on the form.||percent of correctly filled forms||Full Range|Median
647004|NCT02134587|Secondary|Knowledge (Awareness) Regarding Pharmacovigilance|Knowledge assessment will be performed by content analysis of answers obtained from questionnaire, being assigned scores from zero to ten. Definitions related to pharmacovigilance of World Health Organization will be considered gold-standard answers. Scores below five will be classified as unsatisfactory, among five and 7.5 were considered regular and above 7.6 satisfactory on the knowledge acquisition.The questionnaire will be applied in the first (prior to educational intervention) and fourth (post-educational intervention period) meetings. Data will be compared, in order to assess the impact of educational intervention on knowledge of health professionals.|Two days|The subjects were assessed regarding pharmacovigilance´s knowledge prior to educational interventions and after as well, in order to evaluate the effectiveness of the study in aware health professionals to report adverse drug events.||percentage of right answers||Full Range|Median
647046|NCT02133066|Secondary|Length of Antibiotic Use in Ultrasound-assisted Lumbar Puncture Patients Versus Non-ultrasound-assisted Patients|If a lumbar puncture is not successful, this may lead to unnecessary (prophylactic) antibiotic use until a lumbar puncture can be completed (with interventional radiology or other resources) to rule out meningitis. According to our hypothesis, we believe that ultrasound assistance will increase the proportion of successful lumbar punctures, and therefore, decrease the length of unnecessary antibiotics.|Participants will be followed until discontinuation of antibiotics, an expected average of 2 days|||hours||95% Confidence Interval|Median
647005|NCT02134587|Primary|Absolute Number of ADE Reporting (Change Behavior of Health Professionals)|Investigators are going to verify the numbers of adverse drug events reported by health professionals which was made 12 months before educational intervention. A follow up across 12 months post-educational intervention also will be performed, in order to identify the number of adverse drug events reported by health professionals. Prevalence of ADE in both periods will be estimated and compared, in order to asses the impact of the intervention on change behavior of health professionals.|12 months|Before educational intervention, health professionals reported only three adverse drug events, related to therapeutic failure. However, after the study, the number of reports rise 70-fold, since subjects reported 165 medication errors, 26 adverse drug reactions, 18 quality deviations, 5 therapeutic failure and one off-label use.||absolute number of adverse drug events|||Number
647006|NCT02134184|Other Pre-specified|To Compare the T- and B-cell Response to Licensed IM TIV in Elderly Individuals Dependent on the Presence and Duration of CMV Infection by Analyses of Vaccine-induced Plasmablasts, Antibodies and Antigen-specific T Cells||Day 0 to Day 28||||||
647007|NCT02134184|Secondary|Number of Participants With Related Adverse Events||Day 0 to Day 28|||Participants|||Count of Participants
647008|NCT02134184|Primary|Number of Participants From Each Arm Who Received Influenza Vaccine||Day 0 to Day 28|||Participants|||Count of Participants
647009|NCT02134119|Secondary|Hematological Measures - Hemoglobin|as measured by hemoglobin (Hb) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)|35 days|||g/dL||Standard Deviation|Mean
647010|NCT02134119|Secondary|Hematological Measures - Hemoglobin|as measured by hemoglobin (Hb) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)|14 days (mid-intervention)|||g/dL||Standard Deviation|Mean
647011|NCT02134119|Secondary|Hematological Measures - Hemoglobin|as measured by hemoglobin (Hb) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)|0 days (baseline)|||g/dL||Standard Deviation|Mean
647012|NCT02134119|Secondary|Hematological Measures - Hematocrit|as measured by hematocrit (Hct) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)|35 days|||percent of red blood cells in blood||Standard Deviation|Mean
647013|NCT02134119|Secondary|Hematological Measures -Hematocrit|as measured by hematocrit (Hct) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)|14 days (mid-intervention)|||percent of red blood cells in blood||Standard Deviation|Mean
647014|NCT02134119|Secondary|Hematological Measures - Hematocrit|as measured by hematocrit (Hct) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)|0 days (baseline)|||percent of red blood cells in blood||Standard Deviation|Mean
647015|NCT02134119|Secondary|Hematological Measures - Ferritin|as measured by ferritin at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)|35 days|||ng/mL||Standard Deviation|Mean
647016|NCT02134119|Secondary|Hematological Measures - Ferritin|as measured by ferritin at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)|14 days (mid-intervention)|||ng/mL||Standard Deviation|Mean
647017|NCT02134119|Secondary|Hematological Measures - Ferritin|as measured by ferritin at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)|0 days (baseline)|||ng/mL||Standard Deviation|Mean
647018|NCT02134119|Secondary|Hematological Measures - Erythropoietin|as measured by erythropoietin (EPO) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)|35 days|||mU/mL||Standard Deviation|Mean
647019|NCT02134119|Secondary|Hematological Measures - Erythropoietin|as measured by erythropoietin (EPO) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)|14 days (mid-intervention)|||mU/mL||Standard Deviation|Mean
647020|NCT02134119|Secondary|Hematological Measures - Erythropoietin|as measured by erythropoietin (EPO) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)|0 days (baseline)|||mU/mL||Standard Deviation|Mean
647021|NCT02134119|Secondary|Hematological Measures - Red Blood Cells|as measured by red blood cells (RBCs) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)|35 days|||M/uL||Standard Deviation|Mean
647022|NCT02134119|Secondary|Hematological Measures - Red Blood Cells|as measured by red blood cells (RBCs) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)|14 days (mid-intervention)|||M/uL||Standard Deviation|Mean
647023|NCT02134119|Secondary|Hematological Measures - Red Blood Cells|as measured by red blood cells (RBCs) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)|0 days (baseline)|||M/uL||Standard Deviation|Mean
647024|NCT02134119|Primary|VO2 Max|A maximal graded exercise test on a treadmill (TrackMaster, TMX 425, Newton, KS) was used to determine VO2max using the modified Balke protocol. During the treadmill test, expired O2 and CO2 were continually measured using an open circuit metabolic measurement system (MedGraphics Ultima, CardioO2, St. Paul, MN). Participants performed a 5-minute warm-up on a treadmill at 0% grade. After the warm-up, the treadmill speed was then increased until participants were at 75% of their age-predicted maximal heart rate. Once this steady-state HR was achieved, the speed was kept constant while the grade increased by 2.5% every two minutes until volitional exhaustion. Criteria for ensuring that participants achieved VO2max in this study were achieving at least two of the following objective criteria: obtaining at least 90% of age-predicted max HR, a respiratory exchange ratio above 1.05, and/or a plateau in the VO2 response to exercise.|35-days|||ml/kg/min||Standard Deviation|Mean
647025|NCT02134119|Primary|VO2 Max|A maximal graded exercise test on a treadmill (TrackMaster, TMX 425, Newton, KS) was used to determine VO2max using the modified Balke protocol. During the treadmill test, expired O2 and CO2 were continually measured using an open circuit metabolic measurement system (MedGraphics Ultima, CardioO2, St. Paul, MN). Participants performed a 5-minute warm-up on a treadmill at 0% grade. After the warm-up, the treadmill speed was then increased until participants were at 75% of their age-predicted maximal heart rate. Once this steady-state HR was achieved, the speed was kept constant while the grade increased by 2.5% every two minutes until volitional exhaustion. Criteria for ensuring that participants achieved VO2max in this study were achieving at least two of the following objective criteria: obtaining at least 90% of age-predicted max HR, a respiratory exchange ratio above 1.05, and/or a plateau in the VO2 response to exercise.|0-days (baseline)|||ml/kg/min||Standard Deviation|Mean
647026|NCT02133781|Other Pre-specified|To Investigate the Effects of Age and Vaccine Type on B-cell Responses to Influenza Vaccine||Day 0 to 28||||||
647027|NCT02133781|Secondary|Number of Participants With Related Adverse Events||Day 0 to 28 post-immunization|||Participants|||Count of Participants
647031|NCT02133664|Primary|Stroop Color-Word Test|The Stroop test assess attention and executive function.The task consists of 3 tasks with only red, green, and blue colors used. The first task asks the subject to name the colors of spots on cards. If a subject can perform this task the second task is performed in which a subject must read the names of colors listed on cards (which are printed in congruent colors). In the third task, the subject is shown a series of words naming colors but the words and colors are mismatched; so the word “yellow” may be red, the word “blue” may be green and so forth. The subject is instructed to ignore the word and name the color. The subject will have the tendency to read the word rather than name the color, the so-called Stroop effect. This third part of the test is referred to as the interference condition and is the critical measurement. The change in time it takes to complete the interference from baseline to 12 weeks is the outcome measure.|baseline to 12 weeks|Analysis occurs only for participants who completed Stroop at both baseline and 12 weeks||seconds||Standard Deviation|Mean
647032|NCT02133664|Primary|Paced Auditory Serial Addition Task (PASAT)|The PASAT is a measure of working memory and sustained attention frequently used in multiple sclerosis treatment outcome studies. The examinee is presented with a series of numbers at 2 second intervals on an audiotape and responds by always adding the last two numbers on the tape before the next number is presented. The change in total number of correct responses from baseline to 12 weeks is the measurement for the outcome.|Baseline to 12 weeks|Only participants who completed PASAT at both baseline and 12 weeks were analyzed.||correct responses||Standard Deviation|Mean
647033|NCT02133534|Primary|Improved Counts of Endothelial Progenitor Cells|Improvement of endothelial cell (EC) dysfunction will be assessed by improved counts of endothelial progenitor cells.|baseline, 30 days|Early termination because of insufficient accrual. With only one study participant, data could not be analyzed.|||||
647034|NCT02133352|Secondary|Change in BNP Cardiac Biomarker|"Assess the change from baseline in BNP cardiac biomarkers after 180 days of twice daily ranolazine.
Cardiac biomarkers may be completed at optional follow up visit for patients continuing on ranolazine following completion of the 180 day treatment period."|180 days|||pg/mL||Standard Deviation|Mean
647035|NCT02133352|Secondary|Change in Echocardiogram Parameters (LVEF)|"To assess the changes from baseline in echocardiographic parameters (left ventricular geometry and function, LVEF, evidence of diastolic dysfunction, SPAP, right ventricular geometry and function, degree of tricuspid regurgitation) after 180 days of twice daily ranolazine.
An additional echo may be completed at optional follow up visit for patients continuing on ranolazine following completion of the 180 day treatment period."|180 days|||LVEF %||Standard Deviation|Mean
647036|NCT02133352|Secondary|Change in Cardiac Size and Function|"Assess changes from baseline in measurements of cardiac size and function obtained by MRI after 180 days of twice daily ranolazine.
An additional MRI may be completed at optional follow up visit for patients continuing on ranolazine following completion of the 180 day treatment period."|180 days|||% ejection fraction||Standard Deviation|Mean
647037|NCT02133352|Secondary|6 Minute Walk Test (6MWT)|Assess the change from baseline in 6 minute walk test (6MWT) after 180 days of twice daily ranolazine Optional follow up for some patients also includes 6MWT.|180 days|||meters||Standard Deviation|Mean
647038|NCT02133352|Secondary|Percent Change in Other Hemodynamic Parameters|"Assess % change in other hemodynamic parameters, by RHC, from baseline afeter 180 days of ranolazine.
Right atrial pressure (RAP) Systolic pulmonary artery pressure (SPAP) Diastolic pulmonary artery pressure (DPAP) Cardiac output (CO) Cardiac index (CI)"|180 days|||percent change||Standard Deviation|Mean
647039|NCT02133352|Primary|Percent Change in mPAP, PAOP and Pulmonary Vascular Resistance (PVR)|"Assess the percent change in mPAP, PAOP and pulmonary vascular resistance (PVR) by RHC.
Additional RHC completed at optional follow up for patients remaining on ranolazine upon completion of 180 day period."|180 days|We hypothesize that patients with pulmonary hypertension associated with diastolic left ventricular dysfunction treated with Ranolazine (initiated at 500 mg twice daily and increased to 1000mg twice daily) would have improved hemodynamic parameters, functional capacity and exercise tolerance compared to baseline.||percentage change||Standard Deviation|Mean
647040|NCT02133235|Primary|Time Required for Proper Placement of the Endobronchial Blocker||10-15 minutes|||seconds||Standard Deviation|Mean
647041|NCT02133235|Primary|Surgical Grading for Lung Isolation|A: Optimal; B: Lung distension; C: Poor endobronchial blocker placement|10-15 minutes|||participants|||Number
647042|NCT02133131|Secondary|Percentage of Participants Achieving SVR 4 Weeks After Completing All Study Therapy (SVR4)|The percentage of participants achieving SVR4, defined as HCV ribonucleic acid (RNA) <15 IU/mL 4 weeks after completing all study therapy, was determined for each arm. Plasma levels of HCV RNA were measured using the Roche COBAS© AmpliPrep/COBAS© TaqMan© HCV Test v. 2.0.|Up to 16 weeks|Analysis of SVR4 is ongoing and results will be indicated in a future report.|||||
647043|NCT02133131|Primary|Number of Participants Discontinuing Study Therapy Due to an AE|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to Week 12|The APaT population consists of all participants who received ≥1 dose of study drug.||Number of participants|||Number
647044|NCT02133131|Primary|Number of Participants Experiencing at Least 1 Adverse Event (AE)|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to Week 14|The All Participants as Treated (APaT) population consists of all participants who received ≥1 dose of study drug.||Number of participants|||Number
647045|NCT02133131|Primary|Percentage of Participants With Sustained Viral Response (SVR) 12 Weeks After Completing All Study Therapy (SVR12)|The percentage of participants achieving SVR12, defined as HCV ribonucleic acid (RNA) <15 IU/mL 12 weeks after completing all study therapy, was determined for each arm. Plasma levels of HCV RNA were measured using the Roche COBAS© AmpliPrep/COBAS© TaqMan© HCV Test v. 2.0.|Up to 24 weeks|The Per Protocol (PP) population includes all randomized and treated participants who did not have protocol deviations that may substantially affect the results of the primary and secondary endpoints.||Percentage of participants||95% Confidence Interval|Number
647091|NCT02132572|Primary|Percentage of Subjects With First Reoperation Following Use of a BIOCELL™ Textured 410 Implant|Data were retrospectively collected on the percentage of subjects who had a first reoperation following previous breast augmentation with a BIOCELL™ Textured 410 Implant.|3 to 10 years|Per Protocol: Subjects who underwent a primary breast augmentation with BIOCELL™ textured 410 cohesive breast implants 3 to 10 years prior to data collection||Percentage of Subjects|||Number
647047|NCT02133066|Secondary|Length of Hospitalization in Ultrasound-assisted Lumbar Puncture Patients Versus Non-ultrasound-assisted Patients|If a lumbar puncture is not successful, this may lead to a longer hospitalization than necessary until a lumbar puncture can be completed (with interventional radiology or other resources). According to our hypothesis, we believe that ultrasound assistance will increase the proportion of successful lumbar punctures, and therefore, decrease the length of unnecessary hospitalization.|Participants will be followed for the duration of the hospital stay, an expected average of 2 days|||hours||95% Confidence Interval|Median
647048|NCT02133066|Secondary|Percentage of Overall Success of Lumbar Punctures in the Ultrasound-assisted Group Versus the Non-ultrasound-assisted Group|Overall success of lumbar punctures (within 3 attempts) in the non-ultrasound-assisted group compared to the ultrasound-assisted group|30 minutes|||percentage success||95% Confidence Interval|Number
647049|NCT02133066|Primary|Percentage of Successful First Attempt Lumbar Punctures in the Ultrasound-assisted Group as Compared to the Non-ultrasound Assisted Group|First attempt success in ultrasound-assisted group compared to first attempt success in non-ultrasound assisted group|30 minutes|||percent success||95% Confidence Interval|Number
647050|NCT02132949|Secondary|Overall Survival (OS)|OS was defined as the time from enrollment to death from any cause.|Baseline up to death (approximately 6.5 years)|Because the study is ongoing, results of this end point are anticipated by December 2020.|||||
647051|NCT02132949|Secondary|Invasive Disease Free Survival (iDFS) Determined by the Investigator According to RECIST v1.1|iDFS is defined as the time from the first date of no disease (the date of surgery) to the first documentation of progressive invasive disease, relapse, or death. PD: at least a 20% increase in the sum of the longest diameter, taking as reference the smallest sum of the longest diameter observed at previous tumor assessment, or the appearance of any new lesions.|Baseline until disease progression or death due to any cause up to approximately 6.5 years (assessed on Day 1 of Cycles 1-8 [cycle length=2-3 weeks] and every 3 months thereafter until study completion or early termination)|Because the study is ongoing, results of this end point are anticipated by December 2020.|||||
647052|NCT02132949|Secondary|Event-Free Survival Determined by the Investigator According to RECIST v1.1|EFS is defined as the time from enrollment to the first occurrence of progressive disease, relapse, or death from any cause. PD: at least a 20% increase in the sum of the longest diameter, taking as reference the smallest sum of the longest diameter observed at previous tumor assessment, or the appearance of any new lesions.|Baseline until disease progression or death due to any cause up to approximately 6.5 years (assessed on Day 1 of Cycles 1-8 [cycle length=2-3 weeks] and every 3 months thereafter until study completion or early termination)|Because the study is ongoing, results of this end point are anticipated by December 2020.|||||
647053|NCT02132949|Secondary|Percentage of Participants With Clinical Response as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 During the Neoadjuvant Treatment Period|Clinical response was classified as either complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD). CR: disappearance of all target lesions; PR: at least a 30% decrease in the sum of the longest diameter compared to Baseline. SD: neither sufficient shrinkage to qualify for PR nor sufficient (20%) increase to qualify for disease progression, in addition to no new target lesions. PD: at least a 20% increase in the sum of the longest diameter, taking as reference the smallest sum of the longest diameter observed at previous tumor assessment, or the appearance of any new lesions. 95% CIs are calculated with the use of the Clopper-Pearson method.|Baseline until disease progression or death due to any cause up to 24 weeks (assessed on Day 1 of Cycles 1-8 [cycle length=2-3 weeks])|ITT population||percentage of participants||95% Confidence Interval|Number
647054|NCT02132949|Secondary|Percentage of Participants With Total Pathological Complete Response (tpCR) Evaluated at the Time of Surgery Based on Local Pathologist's Assessment After Surgery|tpCR is defined as the absence of any residual invasive cancer in the breast and the absence of any metastatic cells in the regional lymph nodes.|24 weeks after neoadjuvant therapy (Post 8 cycles of neo-adjuvant therapy [cycle length=2¬3 weeks])|ITT population||percentage of participants||95% Confidence Interval|Number
647055|NCT02132949|Secondary|Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Pertuzumab||Screening then prior to pertuzumab infusion (Hour 0) in Cycles 5, 14, 18 thereafter anytime between Cycle 8 Day 21 and surgery, up to treatment completion visit (cycle length=2-3 weeks; up to approximately 6.5 years)|"ITT population. Here, number of participants analyzed include those who were evaluable for the outcome."||percentage of participants|||Number
647056|NCT02132949|Secondary|Percentage of Participants With Drop in LVEF of at Least 10 Points From Baseline and to Below 50% at End of Study|A confirmed event was defined as at least two consecutive readings of declines in LVEF. 95% CIs will be calculated with the use of the Clopper-Pearson method.|Baseline up to approximately 6.5 years|Because the study is ongoing, results of this end point are anticipated by December 2020.|||||
647057|NCT02132949|Secondary|Percentage of Participants With NYHA Class III and IV Heart Failure at the End of Study|LVSD is defined as heart failure. NYHA classifies participants' heart failure condition based on the participant's symptoms. Class III: marked limitation of the physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV: Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases. 95% CIs will be calculated with the use of the Clopper-Pearson method.|Baseline up to approximately 6.5 years|Because the study is ongoing, results of this end point are anticipated by December 2020.|||||
647058|NCT02132949|Secondary|Percentage of Participants With Drop in LVEF of at Least 10 Points From Baseline and to Below 50% During the Adjuvant Treatment Period at Primary Completion Date (03 March 2016)|A confirmed event was defined as at least two consecutive readings of declines in LVEF. 95% CIs was calculated with the use of the Clopper-Pearson method.|Cycle 9 to Cycle 21 (cycle length=3 weeks; up to approximately 8 months) up to clinical cut-off date, 03 March 2016 (Month 20)|Safety analysis population who have started adjuvant treatment and were analyzable at the clinical cut-off date (03 March 2016).||percentage of participants||95% Confidence Interval|Number
647092|NCT02132169|Secondary|Safety of AC 170 0.024% Compared to Its Vehicle|Safety measures (adverse events) of AC 170 0.024% compared to its vehicle were measured at Visit 1-4 and 5 (for subset of patients).|Up to 12 Weeks|Intent to Treat (ITT)||adverse events|||Number
651374|NCT02029755|Primary|Opioid Consumption|opioid consumption of the participants will be followed at postoperative 1, 6, 12, 24, 36, 48 hour (up to 48 hours).|postoperative 48 hour|||mg||Standard Deviation|Mean
647059|NCT02132949|Secondary|Percentage of Participants With NYHA Class III and IV Heart Failure During the Adjuvant Treatment Period at Primary Completion Date (03 March 2016)|LVSD is defined as heart failure. NYHA classifies participants' heart failure condition based on the participant's symptoms. Class III: marked limitation of the physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV: Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases. 95% CIs was calculated with the use of the Clopper-Pearson method.|Cycle 9 to Cycle 21 (cycle length=3 weeks; up to approximately 8 months) up to clinical cut-off date, 03 March 2016 (Month 20)|Safety analysis population who have started adjuvant treatment and were analyzable at the clinical cut-off date (03 March 2016).||percentage of participants||95% Confidence Interval|Number
647060|NCT02132949|Primary|Percentage of Participants With Drop in Left Ventricular Ejection Fraction (LVEF) of at Least 10 Percentage Points From Baseline and to Below 50% During the Neoadjuvant Treatment Period|A confirmed event was defined as at least two consecutive readings of declines in LVEF. 95% CIs are calculated with the use of the Clopper-Pearson method.|Baseline to 24 weeks|Safety analysis population||percentage of participants||95% Confidence Interval|Number
647061|NCT02132949|Primary|Percentage of Participants With New York Heart Association (NYHA) Class III and IV Heart Failure During the Neoadjuvant Treatment Period|Symptomatic left ventricular systolic dysfunction (LVSD) is defined as heart failure. NYHA classifies participants' heart failure condition based on the participant's symptoms. Class III: marked limitation of the physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV: Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases. 95 percent (%) confidence intervals (CIs) are calculated with the use of the Clopper-Pearson method.|Baseline to 24 weeks|Safety analysis population included all participants who received any amount of study drug.||percentage of participants||95% Confidence Interval|Number
647062|NCT02132936|Secondary|Change in Itch as Assessed on a VAS Scale From Baseline to Week 4 (LEO 90100) vs. Week 8 (Calcipotriol BDP Gel).|Maximum itch during the previous 24 hours was assessed on a Visual Analogue Scale - range from 0 (no itch at all) to 100 mm (worst itch one could imagine).|Baseline to Week 4; Baseline to Week 8|||units on a scale||95% Confidence Interval|Mean
647063|NCT02132936|Secondary|Change in Itch as Assessed on a VAS Scale (LEO 90100 vs. the Foam Vehicle Group).|Maximum itch during the previous 24 hours was assessed on a Visual Analogue Scale (VAS) - range from 0 (no itch at all) to 100 mm (worst itch one could imagine).|Baseline to Week 4|||units on a scale||95% Confidence Interval|Mean
647064|NCT02132936|Secondary|Time to ‘Treatment Success’ According to PGA.|"Time to treatment success was calculated as the number of weeks from baseline to the visit where the subject first achieved treatment success.
‘Treatment success’ was defined as achieving ‘clear’ or ‘almost clear’ for subjects with at least ‘moderate’ disease at baseline and ‘clear’ for subjects with ‘mild’ disease at baseline."|From Baseline to Week 12|||weeks||Inter-Quartile Range|Median
647065|NCT02132936|Secondary|Subjects With PASI 75 at Week 4 for LEO 90100 and at Week 8 for Calcipotriol BDP Gel.|Subjects with PASI 75 (a 75% reduction in the modified Psoriasis Area and Severity Index) at Week 4 for LEO 90100 and at Week 8 for calcipotriol BDP gel.|Week 4 for LEO 90100; Week 8 for calcipotriol BDP gel|||percentage of subjects|||Number
647066|NCT02132936|Primary|Treatment Success According to the PGA|"To compare the efficacy of treatment of LEO 90100 at Week 4 to that of calcipotriol BDP gel at Week 8 in subjects with psoriasis vulgaris.
Five-point assessment (clear, almost clear, mild, moderate, and severe) was made for the severity of psoriasis vulgaris on the trunk and limbs at all on-treatment visits using Physician’s Global Assessment of Disease Severity (PGA).
‘Treatment success’ was defined as achieving ‘clear’ or ‘almost clear’ for subjects with at least ‘moderate’ disease at baseline and ‘clear’ for subjects with ‘mild’ disease at baseline."|4 Weeks for LEO 90100 and 8 weeks for calcipotriol BDP gel|||percentage of subjects|||Number
647067|NCT02132832|Primary|Stress as Assessed by the Visual Analogue Stress Scale-Current (VASS-C)|"With the Visual Analogue Stress Scale – Current (VASS-C), current stress level is ranked on a 0 – 10 visual analog scale, with 0 as no stress and 10 as extreme stress, cued by the question “Please rate your current stress level."|week 3|||units on a scale||Standard Deviation|Mean
647068|NCT02132832|Primary|Stress as Assessed by the Visual Analogue Stress Scale-Current (VASS-C)|"With the Visual Analogue Stress Scale – Current (VASS-C), current stress level is ranked on a 0 – 10 visual analog scale, with 0 as no stress and 10 as extreme stress, cued by the question “Please rate your current stress level."|week 2|||units on a scale||Standard Deviation|Mean
647069|NCT02132832|Primary|Stress as Assessed by the Visual Analogue Stress Scale-Current (VASS-C)|"With the Visual Analogue Stress Scale – Current (VASS-C), current stress level is ranked on a 0 – 10 visual analog scale, with 0 as no stress and 10 as extreme stress, cued by the question “Please rate your current stress level."|week 1|||units on a scale||Standard Deviation|Mean
647070|NCT02132832|Primary|Anxiety as Assessed by the Zung Self-Rated Anxiety Scale|"The Zung Self-Rated Anxiety Scale is a widely-used 20 item scale that is scored on a Likert-type scale of 1-4, with 15 questions concerning increasing anxiety levels and five questions concerning decreasing anxiety levels. The scale focuses on the most common general anxiety symptoms and means of coping with stressors that produce anxiety. The range of scores is 20-80:
20-44 Normal Range
45-59 Mild to Moderate Anxiety Levels
60-74 Marked to Severe Anxiety Levels
75-80 Extreme Anxiety Levels"|week 3|||units on a scale||Standard Deviation|Mean
647071|NCT02132832|Primary|Anxiety as Assessed by the Zung Self-Rated Anxiety Scale|"The Zung Self-Rated Anxiety Scale is a widely-used 20 item scale that is scored on a Likert-type scale of 1-4, with 15 questions concerning increasing anxiety levels and five questions concerning decreasing anxiety levels. The scale focuses on the most common general anxiety symptoms and means of coping with stressors that produce anxiety. The range of scores is 20-80:
20-44 Normal Range
45-59 Mild to Moderate Anxiety Levels
60-74 Marked to Severe Anxiety Levels
75-80 Extreme Anxiety Levels"|week 2|||units on a scale||Standard Deviation|Mean
647093|NCT02132169|Primary|Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 3 (Day 22)|Tolerability was assessed upon instillation of study medication, at 30 seconds and 1 minute post study medication instillation. Drop comfort was assessed using a 0-to 10 scale where 0=very comfortable and 10=very uncomfortable.|Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation|Intent to Treat (ITT)||units on a scale||Standard Deviation|Mean
647072|NCT02132832|Primary|Anxiety as Assessed by the Zung Self-Rated Anxiety Scale|"The Zung Self-Rated Anxiety Scale is a widely-used 20 item scale that is scored on a Likert-type scale of 1-4, with 15 questions concerning increasing anxiety levels and five questions concerning decreasing anxiety levels. The scale focuses on the most common general anxiety symptoms and means of coping with stressors that produce anxiety. The range of scores is 20-80:
20-44 Normal Range
45-59 Mild to Moderate Anxiety Levels
60-74 Marked to Severe Anxiety Levels
75-80 Extreme Anxiety Levels"|week 1|||units on a scale||Standard Deviation|Mean
647073|NCT02132832|Primary|Stress as Assessed by the Perceived Stress Scale|The Perceived Stress Scale is a 10 item scale that was developed to measure the degree to which individuals appraise their life as stressful and has been widely used in health studies. The scale has a 5-point Likert response format. The total score is calculated by summing responses. The questions are general in nature and relatively content free with regard to specific population groups. The range of scores is 0-40, with 40 indicating the most stress.|week 3|||units on a scale||Standard Deviation|Mean
647074|NCT02132832|Primary|Stress as Assessed by the Perceived Stress Scale|The Perceived Stress Scale is a 10 item scale that was developed to measure the degree to which individuals appraise their life as stressful and has been widely used in health studies. The scale has a 5-point Likert response format. The total score is calculated by summing responses. The questions are general in nature and relatively content free with regard to specific population groups. The range of scores is 0-40, with 40 indicating the most stress.|week 2|||units on a scale||Standard Deviation|Mean
647075|NCT02132832|Primary|Stress as Assessed by the Perceived Stress Scale|The Perceived Stress Scale is a 10 item scale that was developed to measure the degree to which individuals appraise their life as stressful and has been widely used in health studies. The scale has a 5-point Likert response format. The total score is calculated by summing responses. The questions are general in nature and relatively content free with regard to specific population groups. The range of scores is 0-40, with 40 indicating the most stress.|week 1|||units on a scale||Standard Deviation|Mean
647076|NCT02132832|Primary|Attentional Bias to Marijuana Specific Stimuli Measured Via Analysis of Eye Movements|Eye movements are analyzed using a MiraMetrix S2 Eyetracker. This outcome measure reports a ratio: [(number of anti-saccade errors with marijuana-related images) divided by (total number of anti-saccade errors with marijuana-related images or neutral images)]. Anti-saccade errors are when the subject fails to inhibit fixation onto the image.|week 3|||ratio of errors (see OM description)||Standard Deviation|Mean
647077|NCT02132832|Primary|Attentional Bias to Marijuana Specific Stimuli Measured Via Analysis of Eye Movements|Eye movements are analyzed using a MiraMetrix S2 Eyetracker. This outcome measure reports a ratio: [(number of anti-saccade errors with marijuana-related images) divided by (total number of anti-saccade errors with marijuana-related images or neutral images)]. Anti-saccade errors are when the subject fails to inhibit fixation onto the image.|week 2|||ratio of errors (see OM description)||Standard Deviation|Mean
647078|NCT02132832|Primary|Attentional Bias to Marijuana Specific Stimuli Measured Via Analysis of Eye Movements|Eye movements are analyzed using a MiraMetrix S2 Eyetracker. This outcome measure reports a ratio: [(number of anti-saccade errors with marijuana-related images) divided by (total number of anti-saccade errors with marijuana-related images or neutral images)]. Anti-saccade errors are when the subject fails to inhibit fixation onto the image.|week 1|||ratio of errors (see OM description)||Standard Deviation|Mean
647079|NCT02132767|Secondary|Cost (Hospital)|Compare cost of index hospitalization and cost of rehospitalizations (including ED visits) between groups|Within 60 days of randomization||||||
647080|NCT02132767|Secondary|AF- or Treatment-related Events||Within 60 days of randomization||||||
647081|NCT02132767|Secondary|Outpatient Interventions|Compare frequency of outpatient visits between groups for any cause and AF-related causes|Within 60 days of randomization|||hospital stays < 24 hours|||Number
647082|NCT02132767|Secondary|Length of Stay (Rehospitalization, Including ED Visits)|Compare frequency of readmissions between groups for any cause and AF-related hospitalizations|Within 60 days of randomization|||days||Inter-Quartile Range|Median
647083|NCT02132767|Secondary|Length of Stay (Index Hospitalization)|Overall length of stay for the index hospitalization|Within 60 days post surgery|||days||Inter-Quartile Range|Median
647084|NCT02132767|Secondary|Heart Rhythm Comparison|Compare heart rhythm (number of patients in sustained, stable non-AF rhythm) between treatment arms at 60 days after randomization|60 days after randomization|||participants|||Number
647085|NCT02132767|Secondary|Heart Rhythm Comparison|Compare heart rhythm (patients in sustained, stable non-AF rhythm) between treatment arms at 30 days after randomization|30 days after randomization|||participants|||Number
647086|NCT02132767|Secondary|Heart Rhythm Comparison|Compare heart rhythm (number of patients in sustained, stable non-AF rhythm) between treatment arms at hospital discharge|Hospital discharge|||participants|||Number
647087|NCT02132767|Secondary|Time to Conversion to Sustained, Stable Non-AF Rhythm||Up to index hospital discharge or 7 days post surgery, whichever came first|All randomized patients (intent to treat)||days||Inter-Quartile Range|Median
647088|NCT02132767|Primary|Total Number of Days in Hospital|The total number of days in hospital for any hospitalization that occurs within 60 days of randomization to AF treatment strategy.|Within 60 days of randomization|All randomized patients (intent to treat)||days||Inter-Quartile Range|Median
647089|NCT02132611|Secondary|Procedural Success|Procedural success was defined as success in facilitating stent delivery with a residual stenosis of <50% and without the occurrence of an in-hospital MACE in de novo, severely calcified coronary lesions.|Participants were followed from baseline procedure through the duration of hospital stay, an average of 50.4 hours|||percentage of procedures||95% Confidence Interval|Number
647090|NCT02132611|Primary|Major Adverse Cardiac Event (MACE)|"A Kaplan-Meier analysis was performed to determine the percent probability that a study participant is free from major adverse cardiac events at 30 days.
30-Day MACE is composed of:
Cardiac death
Myocardial Infarction (MI) - defined as a Creatine Kinase Myocardial-Band Isoenzyme (CK-MB) level greater than three (3) times the Upper Limit of Lab Normal (ULN) value with or without new pathologic Q wave
Target Vessel Revascularization (TVR) - defined as a revascularization at the target vessel (inclusive of the target lesion) after the completion of the index procedure"|30 Days|||Percent Probability of Freedom from MACE||95% Confidence Interval|Number
647208|NCT02130999|Secondary|Number of Participants With Adverse Events|Number of participants with treatment-emergent adverse event per treatment arm and overall.|From Baseline to End of Study; Day 5 (± 2 days).|||participants|||Number
647094|NCT02132169|Primary|Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 2 (Day 8)|Tolerability was assessed upon instillation of study medication, at 30 seconds and 1 minute post study medication instillation. Drop comfort was assessed using a 0-to 10 scale where 0=very comfortable and 10=very uncomfortable.|Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation|Intent to Treat (ITT)||units on a scale||Standard Deviation|Mean
647095|NCT02132169|Primary|Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 1 (Day 1)|Tolerability was assessed upon instillation of study medication, at 30 seconds and 1 minute post study medication instillation. Drop comfort was assessed using a 0-to 10 scale where 0=very comfortable and 10=very uncomfortable.|Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation|Intent to Treat (ITT)||units on a scale||Standard Deviation|Mean
647096|NCT02132117|Secondary|Percentage of Participants With at Least a 1-Grade Improvement (Decrease) From Baseline on SSA at Hour 1 on Day 1|The participant assessed their overall severity of rosacea facial redness in the treatment area by using the 5-point SSA scale with photoguide where: 0=no signs of unwanted redness (best) to 4=severe redness (worst). A decrease in the score indicates improvement.|Baseline, Day 1 (Hour 1)|ITT Population included all randomized participants.||percentage of participants|||Number
647097|NCT02132117|Secondary|Change From Baseline on the Symptom Assessment for Rosacea Facial Redness (SA-RFR) Item # 4 at Hours 3, 6, 9 and 12 on Day 29|Participants assessed the burning sensation associated with rosacea facial redness by answering Item #4 of the SA-RFR: “Right now, how much does your face burn because of your facial redness?” using a 5-point scale where 0=less severe to 4=severe. A negative change from Baseline indicates improvement.|Baseline, Day 29 (Hours 3, 6, 9 and 12)|Participants from the ITT Population, all randomized participants, with data available for analysis at the given time-point. Only participants who had a SA-RFR score of 1-4 at Baseline are included in the Analysis.||score on a scale||Standard Deviation|Mean
647098|NCT02132117|Secondary|Percentage of Participants Satisfied or Very Satisfied on Item #9 of Satisfaction Assessment for Rosacea Facial Redness (SAT-RFR) at Hours 3, 6, 9 and 12 on Day 29|Participants assessed their treatment satisfaction by answering Item #9 of the SAT-RFR: “Right now, how satisfied are you with the effect your study medication had on your facial redness?” using a 5-point scale where 0= very dissatisfied, 1=dissatisfied, 2=neither satisfied or dissatisfied, 3=satisfied, or 4=very satisfied. The percentage of participants who answered Satisfied or Very Satisfied is reported.|Day 29 (Hours 3, 6, 9 and 12)|Participants from the ITT Population, all randomized participants with data available for analysis.||percentage of participants|||Number
647099|NCT02132117|Secondary|Percent Change From Baseline on Rosacea Facial Redness as Measured by Digital Imaging Analysis (DIA) at Hours 3, 6, 9 and 12 on Day 29|DIA of photographs was used to assess rosacea facial redness and was defined as percentage of facial area occupied by redness. A higher value in the percentage of facial area occupied by facial redness indicated more redness. A negative/ lower number percent change from Baseline indicates improvement.|Baseline, Day 29 (Hours 3, 6, 9 and 12)|ITT Population included all randomized participants.||percent change in area of redness||Full Range|Median
647100|NCT02132117|Secondary|Percentage of Participants With at Least a 2-Grade Improvement (Decrease) From Baseline on SSA at Hours 3, 6, 9 and 12 on Day 29|The participant assessed their overall severity of rosacea facial redness in the treatment area by using the 5-point SSA scale with photoguide where: 0=no signs of unwanted redness (best) to 4=severe redness (worst). A decrease in the score indicates improvement. The percentage of participants with at least a 2-grade decrease (improvement) on SSA from Baseline was evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) post-dose on Day 29.|Baseline, Day 29 (Hours 3, 6, 9 and 12)|ITT Population included all randomized participants.||percentage of participants|||Number
647101|NCT02132117|Primary|Percentage of Participants With at Least a 2-Grade Improvement (Decrease) From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment for Rosacea Facial Redness (SSA) 5-point Scales|The investigator assessed the participant’s overall severity of erythema in the treatment area by using the 5-point CEA scale with photonumeric guide where: 0=clear skin with no signs of erythema (best) to 4=severe erythema; fiery redness (worst). A decrease in the score indicates improvement. The participant assessed their overall severity of rosacea facial redness in the treatment area by using the 5-point SSA scale with photoguide where: 0=no signs of unwanted redness (best) to 4=severe redness (worst). A decrease in the score indicates improvement. The percentage of participants with at least a 2-grade decrease (improvement) on both CEA and SSA from Baseline was evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) post-dose on Day 29. Baseline was defined as the measurement at pre-dose on Day 1.|Baseline, Day 29 (Hours 3, 6, 9 and 12)|Intent-to-treat (ITT) Population included all randomized participants.||percentage of participants|||Number
647102|NCT02131636|Secondary|Percentage of Patients With at Least a 1-Grade Decrease From Baseline on the SSA 5-point Scale|The patient assessed the overall severity of rosacea facial redness in the treatment area on the 5 point SSA scale (ranging from 0=no signs of unwanted redness to 4=severe redness). The percentage of patients with at least a 1 grade decrease (improvement) on the SSA from baseline at Day 1 hour 1. Baseline was defined as the measurement at predose on Day 1.|Baseline, Day 1 (Hour 1)|Intent-to-Treat: all randomized patients||Percentage of Pateints|||Number
647103|NCT02131636|Secondary|Change From Baseline on the SA-RFR Questionnaire Item #4|The SA-RFR questionnaire item 4 is completed by patients assessing how much their face burned due to facial redness on a 5 point scale (range 0=does not burn at all and 4=burns a lot). Patients were evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) postdose on Day 29. A lower score change from baseline (negative number) indicates a decrease in facial redness (improvement), and a higher score change from baseline (positive number) indicates an increase in facial burning (worsening).|Baseline, Day 29 (Hours 3, 6, 9, and 12)|Intent-to-Treat: all randomized patients||Scores on a Scale||Standard Deviation|Mean
647104|NCT02131636|Secondary|Percentage of Patients Reporting Treatment Satisfaction on the Satisfaction Assessment for Rosacea Facial Redness (SA-RFR) Questionnaire Item 9|The SA-RFR questionnaire item 9 is completed by patients assessing treatment satisfaction on facial redness. Patients reporting treatment satisfaction as “very satisfied” or “satisfied” are noted. The percentage of patients was evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) postdose on Day 29.|Day 29 (Hours 3, 6, 9, and 12)|Intent-to-Treat: all randomized patients||Percentage of Patients|||Number
650035|NCT02062905|Primary|Ocular Itching|"Proprietary Ora Calibra Conjunctival Allergen Challenge Ocular Itching Scale (0 - 4 with 0.5 unit increments allowed; 0 = no itching)"|14 days post insertion|||units on a scale (0 -4)||Standard Deviation|Mean
647105|NCT02131636|Secondary|Percent Change From Baseline in Rosacea Facial Redness as Measured by Digital Imaging Analysis (DIA)|Rosacea facial redness in the treatment area was measured by DIA. The percent change was evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) postdose on Day 29. Baseline was defined as the measurement at predose on Day 1. A negative number change from baseline indicates a decrease in facial redness (improvement), and a positive number change from baseline indicates an increase in facial redness (worsening).|Baseline, Day 29 (Hours 3, 6, 9, and 12)|Intent-to-Treat: all randomized patients with data at the time point||Percent Change||Standard Deviation|Mean
647106|NCT02131636|Secondary|Percentage of Patients With at Least a 2-Grade Decrease From Baseline on the SSA 5-point Scale|The patient assessed the overall severity of rosacea facial redness in the treatment area on the 5 point SSA scale (ranging from 0=no signs of unwanted redness to 4=severe redness). The percentage of patients with at least a 2 grade decrease (improvement) from baseline was evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) postdose on day 29. Baseline was defined as the measurement at predose on Day 1.|Baseline, Day 29 (Hours 3, 6, 9, and 12)|Intent-to-Treat: all randomized patients||Percentage of Patients|||Number
647107|NCT02131636|Primary|Percentage of Patients With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Satisfaction Assessment (SSA) 5-point Scales|The investigator assessed the patient’s overall severity of erythema in the treatment area on the 5 point CEA scale (ranging from 0=clear skin with no signs of erythema to 4=severe erythema/fiery redness). The patient assessed the overall severity of rosacea facial redness in the treatment area on the 5 point SSA scale (ranging from 0=no signs of unwanted redness to 4=severe redness). The percentage of patients with at least a 2 grade decrease (improvement) on both CEA and SSA from baseline was evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) postdose on day 29. Baseline was defined as the measurement at predose on Day 1.|Baseline, Day 29 (Hours 3, 6, 9, and 12)|Intent-to-Treat: all randomized patients||Percentage of Patients|||Number
647108|NCT02131532|Primary|Feasibility of Follow-up Assessment at Three Months After the End of Treatment|Numbers of participants who completed and returned the questionnaires on time (as required) and of those who delayed the completion.|3 months after the end of treatment|||participants|||Number
647109|NCT02131532|Primary|Feasibility of Telephone-delivered Booster Sessions|Numbers of participants who attended the booster session as planned and those who rearranged the session|3 months after the end of treatment|||participants|||Number
647110|NCT02131532|Primary|Attendance of Treatment Sessions|Number of participants who completed all treatment sessions.|3 months after the end of treatment|||participants|||Number
647111|NCT02131532|Primary|Feasibility of Recruitment Process|The numbers of stroke patients involved at each stage of recruitment were reported under this outcome.|3 months after the end of treatment|||participants|||Number
647112|NCT02131532|Secondary|SIS - Social Activity|The social activity subscale of the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes.|3 months after the end of treatment|||units on a scale||Standard Deviation|Mean
647113|NCT02131532|Secondary|SIS - Hand Function|The hand function subscale of the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes.|3 months after the end of treatment|||units on a scale||Standard Deviation|Mean
647114|NCT02131532|Secondary|SIS - Mobility|The mobility subscale of the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes.|3 months after the end of treatment|||units on a scale||Standard Deviation|Mean
647115|NCT02131532|Secondary|SIS - Daily Activities|The daily activities subscale of the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes.|3 months after the end of treatment|||units on a scale||Standard Deviation|Mean
647116|NCT02131532|Secondary|SIS - Communication|The communication subscale of the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes.|3 months after the end of treatment|||units on a scale||Standard Deviation|Mean
647117|NCT02131532|Secondary|SIS - Emotion|The emotion subscale of the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes.|3 months after the end of treatment|||units on a scale||Standard Deviation|Mean
647118|NCT02131532|Secondary|SIS - Memory and Thinking|The memory and thinking subscale of the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes.|3 months after the end of treatment|||units on a scale||Standard Deviation|Mean
647119|NCT02131532|Secondary|SIS - Physical Strength|The physical strength subscale of the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes.|3 months after the end of treatment|||units on a scale||Standard Deviation|Mean
647120|NCT02131532|Secondary|Stroke Impact Scale (SIS) - General Rating of Recovery|The general rating scale on the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes of recovery.|3 months after the end of treatment|||units on a scale||Standard Deviation|Mean
647121|NCT02131532|Secondary|Nottingham Extended Activities of Daily Living (NEADL)|The total NEADL score ranges from 0 to 22, with higher scores indicating better outcomes of independence.|3 months after the end of treatment|||units on a scale||Standard Deviation|Mean
647122|NCT02131532|Secondary|Patient Health Questionnaire-9 (PHQ-9)|The total PHQ-9 score ranges from 0 to 27, with higher scores indicating worse outcomes of depressive symptoms.|3 months after the end of treatment|||units on a scale||Standard Deviation|Mean
647123|NCT02131532|Secondary|Fatigue Assessment Scale (FAS)|"This is the primary clinical outcome for this intervention (but clinical outcomes are all secondary outcomes for this pilot feasibility study).
The total FAS score ranges from 10 to 50, with higher scores indicating worse outcomes of fatigue severity."|3 months after the end of treatment|||units on a scale||Standard Deviation|Mean
647124|NCT02131402|Primary|Eye Care Practitioner's Objective Assessment of Binocular High Contrast Distance Visual Acuity - Enfilcon A / Methafilcon A|Visual acuity assessed after insertion of each study lens, prior to dispensing contralateral pairs- Pair #3. LogMAR Visual Acuity (VA) to nearest letter)|1 hour post settling|||LogMAR||Standard Deviation|Mean
647125|NCT02131402|Primary|Eye Care Practitioner's Objective Assessment of Binocular High Contrast Distance Visual Acuity - Enfilcon A / Ocufilcon D|Visual acuity assessed after insertion of each study lens, prior to dispensing contralateral pairs- Pair #2. LogMAR Visual Acuity (VA) to nearest letter)|1 hour post settling|||LogMAR||Standard Deviation|Mean
647126|NCT02131402|Primary|Eye Care Practitioner's Objective Assessment of Binocular High Contrast Distance Visual Acuity - Enfilcon A / Omafilcon A|Visual acuity assessed after insertion of each study lens, prior to dispensing contralateral pairs Pair #1. LogMAR Visual Acuity (VA) to nearest letter)|1 hour post settling|||LogMAR||Standard Deviation|Mean
647127|NCT02131402|Primary|Participant's Subjective Rating for Stinging/Burning - Enfilcon A / Methafilcon A|Surveyed after 1 hour post settling for Pair #3. Rated by questionnaires (0-100,0= no sensation of stinging/burning,100= extreme stinging).|1 hour post settling|||units on a scale||Standard Deviation|Mean
647128|NCT02131402|Primary|Participant's Subjective Rating for Stinging/Burning - Enfilcon A / Ocufilcon D|Surveyed after 1 hour post settling for Pair #2. Rated by questionnaires (0-100,0= no sensation of stinging/burning, 100= extreme stinging).|1 hour post settling|||units on a scale||Standard Deviation|Mean
647129|NCT02131402|Primary|Participants Subjective Rating for Stinging/Burning - Enfilcon A / Omafilcon A|Surveyed after 1 hour of lens wear for each lens at lens removal Pair #1. Rated by questionnaires (0-100,0=no sensation of stinging/burning 100=extreme stinging).|1 hour post settling|||units on a scale||Standard Deviation|Mean
647130|NCT02131402|Primary|Participant Subjective Rating for Stinging/Burning - Enfilcon A / Methafilcon A|Surveyed after insertion of each lens for Pair #3. Rated by questionnaires (0-100,0=no sensation of stinging/burning, 100=extreme stinging).|Baseline|||units on a scale||Standard Deviation|Mean
647131|NCT02131402|Primary|Participant Subjective Rating for Stinging/Burning - Enfilcon A / Ocufilcon D|Surveyed after insertion of each lens Pair #2 at baseline. Rated by questionnaires (0-100,0=no sensation of stinging/burning 100=extreme stinging)|Baseline|||units on a scale||Standard Deviation|Mean
647132|NCT02131402|Primary|Participant's Subjective Rating for Stinging/Burning - Enfilcon A / Omafilcon A|Surveyed after insertion of each lens for Pair #1 at baseline visit. Rated by questionnaires (0-100, 0=no sensation of stinging/burning, 100= extreme stinging).|Baseline|||units on a scale||Standard Deviation|Mean
647133|NCT02131402|Primary|Eye Care Practitioner's Objective Assessment of Lens Fit, Centration - Enfilcon A / Methafilcon A|Assessed after 1 hour post settling for Pair #3, (4 possible ratings: optimum, Decentration acceptable, Decentration unacceptable)|1 hour post settling|||percentage of eyes|Eyes||Number
647134|NCT02131402|Primary|Eye Care Practitioner's Objective Assessment of Lens Fit, Centration - Enfilcon A / Ocufilcon D|Assessed after 1 hour post settling for Pair #2. (4 possible ratings: optimum, Decentration acceptable, Decentration unacceptable)|1 hour post settling|||percentage of eyes|Eyes||Number
647135|NCT02131402|Primary|Eye Care Practitioner's Objective Assessment of Lens Fit, Centration - Enfilcon A / Omafilcon A|Assessed after 1 hour post settling of lens wear for Pair #1. (4 possible ratings: optimum, Decentration acceptable, Decentration unacceptable).|1 hour post settling|||percentage of eyes|Eyes||Number
647136|NCT02131402|Primary|Eye Care Practitioner's Objective Assessment of Lens Fit, Tightness Push-up Test - Enfilcon A / Methafilcon A|Assessed after 1 hour post settling for Pair #3. (Scale 0%-100%, 0%-100%, continuous scale where 100%=no movement, 50%=optimum, 0%=Falls from cornea without lid support)|1 hour post settling|||units on a scale||Standard Deviation|Mean
647137|NCT02131402|Primary|Eye Care Practitioner's Objective Assessment of Lens Fit, Tightness Push-up Test - Enfilcon A / Ocufilcon D|Assessed after 1 hour post settling for Pair #2, (0%-100%, continuous scale where 100%=no movement, 50%=optimum, 0%=Falls from cornea without lid support).|1 hour post settling|||units on a scale||Standard Deviation|Mean
647138|NCT02131402|Primary|Eye Care Practitioner's Objective Assessment of Lens Fit, Tightness Push-up Test - Enfilcon A / Omafilcon A|Assessed after 1 hour post settling of lens wear for Pair #1. Slit lamp. (0%-100%, continuous scale where 100%=no movement, 50%=optimum, 0%=Falls from cornea without lid support).|1 hour post settling|||units on a scale||Standard Deviation|Mean
647139|NCT02131402|Primary|Eye Care Practitioner's Objective Assessment of Lens Fit, Post-blink Movement, and Primary Gaze Lag - Enfilcon A / Methafilcon A|Assessed after 1 hour post settling for Pair #3. (0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement)|1 hour post settling|||units on a scale||Standard Deviation|Mean
647140|NCT02131402|Primary|Eye Care Practitioner's Objective Assessment of Lens Fit, Post-blink Movement, and Primary Gaze Lag - Enfilcon A / Ocufilcon D|Assessed after 1 hour post settling for Pair #2. (0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement)|1 hour post settling|||units on a scale||Standard Deviation|Mean
647141|NCT02131402|Primary|Eye Care Practitioner's Objective Assessment of Lens Fit, Post-blink Movement, and Primary Gaze Lag - Enfilcon A / Omafilcon A|Assessed after 1 hour post settling of lens wear for Pair #1. Slit lamp (0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement)|1 hour post settling|||units on a scale||Standard Deviation|Mean
647142|NCT02131402|Primary|Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Methafilcon A|Surveyed after 1 hour post settling for Pair #3. Rated by questionnaire (4 possible ratings: Strong Enfilcon A, Slight Enfilcon A, No preference, Slight Methafilcon A, Strong Methafilcon A).|1 hour post settling|||percentage of subjects|||Number
647143|NCT02131402|Primary|Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Ocufilcon D|Surveyed after 1 hour post settling for Pair #2. Rated by questionnaire (4 possible ratings: Strong Enfilcon A, Slight Enfilcon A, No preference, Slight Ocufilcon D, Strong Ocufilcon D).|1 hour post settling|||percentage of subjects|||Number
647144|NCT02131402|Primary|Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Omafilcon A|Surveyed after 1 hour post settling (1 hour) of lens wear for Pair #1. Rated by subjects preference for test lens or control lens (Strong Enfilcon A, Slight Enfilcon A, No preference, Slight Omafilcon A, Strong Omafilcon A).|1 hour post settling|||percentage of subjects|||Number
647145|NCT02131402|Primary|Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Methafilcon A|Surveyed after insertion of each lens for Pair #3. Rated by questionnaire (4 possible ratings: Strong Enfilcon A, Slight Enfilcon A, No preference, Slight Methafilcon A, Strong Methafilcon A).|Baseline|||percentage of eyes|||Number
647146|NCT02131402|Primary|Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Ocufilcon D|Surveyed at insertion of each lens Pair #2 by questionnaire (4 possible ratings: Strong Enfilcon A, Slight Enfilcon A, No preference, Slight Ocufilcon D, Strong Ocufilcon D).|Baseline|||percentage of subjects|||Number
647147|NCT02131402|Primary|Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Omafilcon A|Surveyed after insertion of each lens Pair #1 at (Baseline visit). Rated by questionnaire (4 possible ratings: Strong Enfilcon A, Slight Enfilcon A, No preference, Slight Omafilcon A, Strong Omafilcon A).|Baseline|||percentage of subjects|||Number
647148|NCT02131402|Primary|Participant's Subjective Rating for Lens Comfort - Enfilcon A / Methafilcon A|Surveyed after 1 hour post settling for Pair #3. Rated by questionnaires (0-100,0=Can't be worn and causes pain 100= can't feel).|1 hours post settling|||units on a scale||Standard Deviation|Mean
647149|NCT02131402|Primary|Participant's Subjective Rating for Lens Comfort - Enfilcon A / Ocufilcon D|Surveyed after 1 hour post settling for Pair #2. Rated by questionnaires (0-100 0=Can't be worn and causes pain, 100= can't feel).|1 hour post settling|||units on a scale||Standard Deviation|Mean
647150|NCT02131402|Primary|Participant's Subjective Rating for Lens Comfort - Enfilcon A / Omafilcon A|Surveyed after 1 hour post settling for Pair #1. Rated by questionnaires (0-100, 0= Can't be worn and causes pain, 100= can't feel).|1 hour post settling|||units on a scale||Standard Deviation|Mean
647151|NCT02131402|Primary|Participant's Subjective Rating for Lens Comfort - Enfilcon A / Methafilcon A|Surveyed after insertion Pair #3 (baseline). Rated by questionnaires (0-100, 0-Can't be worn, 100= can't feel).|Baseline|||units on a scale||Standard Deviation|Mean
647152|NCT02131402|Primary|Participant's Subjective Rating for Lens Comfort - Enfilcon A / Omafilcon A|Surveyed after insertion of each lens at baseline visit for Pair #1. Rated by questionnaires (0-100, 0-Can't be worn and causes pain,100= can't feel).|Baseline|||units on a scale||Standard Deviation|Mean
647153|NCT02131402|Primary|Participants Subjective Rating for Lens Comfort - Enfilcon A / Ocufilcon D|Surveyed after insertion of each lens Pair #2 (at insertion). Rated by Questionnaire (0-100,0=Can't be worn and causes pain, 100=can't feel).|Baseline|||units on a scale||Standard Deviation|Mean
647154|NCT02131402|Primary|Participant's Subjective Rating for Lens Handling - Enfilcon A / Methafilcon A|Surveyed after 1 hour of lens wear for each lens at lens removal Pair #3. Rated by questionnaires (0-100 0=Very difficult, 100= very easy).|1 hour post settling|||units on a scale||Standard Deviation|Mean
647155|NCT02131402|Primary|Participant's Subjective Rating for Lens Handling - Enfilcon A / Ocufilcon D|Surveyed after 1 hour of lens wear for each lens at lens removal for Pair #2 (1 hour). Rated by questionnaires (0=Very difficult 0-100, 100= very easy).|1 hour post settling|||units on a scale||Standard Deviation|Mean
647156|NCT02131402|Primary|Participant's Subjective Rating for Lens Handling - Enfilcon A / Omafilcon A|Surveyed after 1 hour of lens wear for each lens at lens removal Pair #1 (1 hour). Rated by questionnaires (0= Very difficult 0-100, 100= very easy).|1 hour post settling|||units on a scale||Standard Deviation|Mean
647157|NCT02131311|Secondary|Percentage of Responders for Pad Weight Gain or SUI Episodes||from the 14-day baseline period to the first 7 days of 14-day device usage period|"Intent-to-Treat (ITT) population. The Number of Participants Analyzed is the number subjects with available (non-missing) data in week 1"||percentage of subjects|||Number
647158|NCT02131311|Secondary|Change in Pad Weight Gain|change from baseline as measured as reduction (improvement) in pad weight gain. Positive values are indicative of efficacious outcome.|from the 14-day baseline period to the first 7 days of a 14-day device usage period|"Intent-to-Treat (ITT) population. The Number of Participants Analyzed is the number subjects with available (non-missing) data in week 1"||grams/usage period||Inter-Quartile Range|Median
647159|NCT02131311|Secondary|Change in Stress Urinary Incontinence Episodes|change from baseline as measured as reduction (improvement) in stress urinary incontinence episodes. Positive values are indicative of efficacious outcome.|from the 14-day baseline period to the first 7 days of 14-day device usage period|"Intent-to-Treat (ITT) population. The Number of Participants Analyzed is the number subjects with available (non-missing) data in week 1"||number of episodes/usage period||Inter-Quartile Range|Median
647160|NCT02131311|Secondary|Change in Quality of Life as Measured by Incontinence Impact Questionnaire (IIQ-7)|The IIQ-7 is based on 7 questions referring to areas which may have been influenced or changed by accidental urine loss and/or prolapse. These questions are assigned a value of, 0 = ‘Not at all,’ 1= ‘Slightly,’ 2 = ‘Moderately,’ or 3 ‘Greatly.’ The IIQ-7 is scored by taking the average score of items and then multiplying the average by 33 1/3 to put scores on a scale from 0 to 100. A lower score is considered less impact to quality of life and a higher score reflects more impact to quality of life. In the same manner, a reduction in scores from baseline reflects improved quality of life.|baseline and end-of-treatment|"Intent-to-Treat (ITT) population. The Number of Participants Analyzed is the number subjects with available (non-missing) data at end of treatment"||units on a scale||Inter-Quartile Range|Median
647161|NCT02131311|Secondary|Change in Pad Weight Gain|change from baseline as measured as reduction (improvement) in pad weight gain. Positive values are indicative of efficacious outcome.|from the 14-day baseline period to the last 7 days of 14-day device usage period|"Intent-to-Treat (ITT) population. The Number of Participants Analyzed is the number subjects with available (non-missing) data in week 2"||grams/usage period||Inter-Quartile Range|Median
647162|NCT02131311|Secondary|Change in Stress Urinary Incontinence Episodes|change from baseline as measured as reduction (improvement) in stress urinary incontinence episodes. Positive values are indicative of efficacious outcome.|from the 14-day baseline period to the last 7 days of 14-day device usage period|"Intent-to-Treat (ITT) population. The Number of Participants Analyzed is the number subjects with available (non-missing) data in week 2"||episodes/usage period||Inter-Quartile Range|Median
647163|NCT02131311|Primary|Percentage of Responders for Pad Weight Gain or SUI Episodes||from the 14-day baseline period to the last 7 days of 14-day device usage period|"Intent-to-Treat (ITT) population. The Number of Participants Analyzed is the number subjects with available (non-missing) data in week 2"||percentage of subjects|||Number
647164|NCT02131272|Secondary|Incidence of Adverse Events (AEs)|The total number of treatment emergent adverse events (the onset of the adverse event is on or after the first day of trial product administration, and no later than 7 days after the last day of trial product administration) reported during the 26 weeks of treatment.|weeks 0 - 26|Safety analysis set included all subjects receiving at least one dose of randomised treatment.||Number of events|||Number
647356|NCT02127567|Primary|The Primary Outcome Will be the Average Score for Completeness of Reporting on a Scale of 0-10.|Completeness of reporting will be determined according to a grading rubric individualized to each study protocol, 0 being the lowest and 10 the highest|one time measure after a four-hour writing session|||units on a scale|Participants|Standard Deviation|Mean
647165|NCT02131272|Secondary|Total Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes|Total number of treatment emergent severe (an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or blood glucose confirmed symptomatic hypoglycaemic episodes (plasma glucose value <3.1 mmol/L [56 mg/dL] with symptoms consistent with hypoglycaemia) experienced by the subjects during the trial.|Weeks 0 - 26|Safety analysis set included all subjects receiving at least one dose of randomised treatment.||Number of episodes|||Number
647166|NCT02131272|Secondary|Total Number of Treatment Emergent Nocturnal (23:00-06:59) Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes|The total number of blood glucose confirmed symptomatic nocturnal (time of onset between 23:00 and 06.59 both inclusive) severe (an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or blood glucose confirmed symptomatic hypoglycaemic episodes (plasma glucose value <3.1 mmol/L [56 mg/dL] with symptoms consistent with hypoglycaemia) experienced by the subjects during the trial.|Weeks 0 - 26|Safety analysis set included all subjects receiving at least one dose of randomised treatment.||Number of episodes|||Number
647167|NCT02131272|Secondary|Proportion of Subjects Achieving HbA1c Below 7.5%, Who Have Not Experienced Any Treatment Emergent Severe Hypoglycaemic Episodes Within the Last 14 Weeks of Treatment|Proportion of subjects achieving HbA1c below 7.5% is presented as percentage of subjects achieving HbA1c <7.5%, who have not experienced any treatment emergent severe hypoglycaemic episodes (an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) within the last 14 weeks of treatment.|At week 26|Full analysis set included all the randomised subjects. Only subjects who have been exposed for a minimum of 14 weeks contributed to the analysis (20 subjects in the Insulin detemir + metformin + diet/exercise arm and 21 subjects in the Insulin NPH + metformin + diet/exercise arm).||Percentage of subjects|||Number
647168|NCT02131272|Secondary|Proportion of Subjects Achieving HbA1c Below 7.0%, Who Have Not Experienced Any Treatment Emergent Severe Hypoglycaemic Episodes Within the Last 14 Weeks of Treatment.|Proportion of subjects achieving HbA1c <7.0% is presented as percentage of subjects achieving HbA1c <7.0%, who have not experienced any treatment emergent severe hypoglycaemic episodes (an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) within the last 14 weeks of treatment.|At week 26|Full analysis set included all the randomised subjects. Only subjects who have been exposed for a minimum of 14 weeks contributed to the analysis (20 subjects in the Insulin detemir + metformin + diet/exercise arm and 21 subjects in the Insulin NPH + metformin + diet/exercise arm).||Percentage of subjects|||Number
647169|NCT02131272|Secondary|Change in Body Weight Standard Deviation Score (SDS)|Change in body weight standard deviation score (SDS) from baseline to week 26. In order to reduce the variability in body weight measurements, SDS were calculated. SDS for weight was derived by comparing the actual measurements with standard growth charts for the United States. Standard values provided by the standard growth charts according to the subject’s sex and age at the time of the measurement were used to calculate the SDS.|week 0, week 26|Full analysis set included all the randomised subjects.||standard deviation score||Standard Deviation|Mean
647170|NCT02131272|Primary|Change in HbA1c (Glycosylated Haemoglobin)|Estimated mean change in HbA1c (glycosylated haemoglobin) from baseline to week 26.|week 0, week 26|Full analysis set included all the randomised subjects.||Percentage of glycosylated haemoglobin||Standard Error|Least Squares Mean
647171|NCT02131233|Secondary|Percentage of Participants Who Discontinued From Drug Therapy Due to an AE at Week 96|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an AE.|Up to Week 96||12/2017||||
647172|NCT02131233|Secondary|Percentage of Participants With a Serious and Drug-Related AE at Week 96|A SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. An investigator who is a qualified physician will evaluate whether or not a SAE is drug-related.|Up to Week 96||12/2017||||
647173|NCT02131233|Secondary|Percentage of Participants With a SAE at Week 96|A SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event.|Up to Week 96||12/2017||||
647174|NCT02131233|Secondary|Percentage of Participants With a Drug-Related AE at Week 96|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an AE. An investigator who is a qualified physician evaluated whether or not an AE was drug-related.|Up to Week 96||12/2017||||
647175|NCT02131233|Secondary|Percentage of Participants With an AE at Week 96|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an AE.|Up to Week 96||12/2017||||
647176|NCT02131233|Secondary|Percentage of Participants Who Discontinued From Drug Therapy Due to an AE at Week 48|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an AE|Up to Week 48|All randomized participants who received at least one dose of study treatment.||Percentage of participants|||Number
647177|NCT02131233|Secondary|Percentage of Participants With a Serious and Drug-Related AE at Week 48|A SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. An investigator who is a qualified physician evaluated whether or not a SAE is drug-related.|Up to Week 48|All randomized participants who received at least one dose of study treatment.||Percentage of participants|||Number
647178|NCT02131233|Secondary|Percentage of Participants With a Serious Adverse Event (SAE) at Week 48|A serious adverse event (SAE) is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event.|Up to Week 48|All randomized participants who received at least one dose of study treatment.||Percentage of participants|||Number
647179|NCT02131233|Secondary|Percentage of Participants With a Drug-Related AE at Week 48|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an AE. An investigator who is a qualified physician evaluated whether or not an AE was drug-related.|Up to Week 48|All randomized participants who received at least one dose of study treatment.||Percentage of participants|||Number
647180|NCT02131233|Secondary|Percentage of Participants With an Adverse Event (AE) at Week 48|An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an AE.|Up to Week 48|All randomized participants who received at least one dose of study treatment.||Percentage of participants|||Number
647181|NCT02131233|Secondary|Change From Baseline in CD4 Cell Count at Week 96|CD4 cells will be counted from blood collected at baseline and week 96, and the change from baseline determined from week 96 minus baseline values.|Baseline and Week 96||12/2017||||
647182|NCT02131233|Secondary|Percentage of Participants Achieving <40 Copies/mL HIV-1 RNA at Week 96|From blood samples collected at week 96, HIV-1 RNA levels will be determined by the Abbott RealTime HIV-1 Assay, which has a limit of reliable quantification (LoQ) of 40 copies/mL.|Week 96||12/2017||||
647183|NCT02131233|Secondary|Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 48|CD4 cells were counted from blood collected at baseline and week 48, and the change from baseline determined from week 48 minus baseline values.|Baseline and Week 48|All randomized participants who received at least one dose of study treatment and have baseline data. The Observed Failure (OF) approach to handling missing values assumed baseline-carry-forward for all failures, and excluded other missing values.||cells/mm^3||95% Confidence Interval|Mean
647184|NCT02131233|Primary|Percentage of Participants Achieving <40 Copies/mL Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) at Week 48|From blood samples collected at week 48, HIV-1 RNA levels were determined by the Abbott RealTime HIV-1 Assay, which has a limit of reliable quantification (LoQ) of 40 copies/mL. The NC=F approach as defined by FDA “snapshot” approach was used as the primary approach to analysis where all missing data were treated as failures regardless of the reason.|Week 48|All randomized participants who received at least one dose of study treatment||Percentage of participants||95% Confidence Interval|Number
647185|NCT02131064|Secondary|Percentage of Participants With ATA to Trastuzumab||Baseline (Pre-trastuzumab [0 hr] infusion [infusion duration = 90 min] on Day 1 of Cycle 1); post-baseline (Pre-trastuzumab infusion [0 hr] on Day 1 of Cycle 6) (each cycle = 21 days) in neoadjuvant and adjuvant period||01/2019||||
647186|NCT02131064|Secondary|Percentage of Participants With Anti-Therapeutic Antibodies (ATA) to TDM-1|Participants were considered post-baseline ATA positive if they had ATAs post-baseline that were either treatment-induced or treatment-enhanced. Participants had treatment-induced ATAs if they had a negative or missing ATA result at baseline, and at least one positive ATA result post-baseline. Participants had treatment-enhanced ATAs if they had a positive ATA result at baseline, and at least one positive ATA result post-baseline that was greater than or equal to (>/=) 0.60 titer units higher than the result at baseline.|Baseline (Pre-TDM1 [0 hr] infusion [infusion duration = 90 min] on Day 1 of Cycle 1); post-baseline (Pre-TDM1 infusion [0 hr] on Day 1 of Cycle 6) (each cycle = 21 days) in neoadjuvant period|ITT population, including participants from T-DM1 + P arm only. Overall number of participants analyzed = participants evaluable for this outcome measure. Number Analyzed = participants evaluable for the specified category.||percentage of participants|||Number
648546|NCT02100514|Secondary|Absolute Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12||Baseline, Week 12|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."||mg/dL||Standard Deviation|Mean
647187|NCT02131064|Secondary|Serum Levels of Plasma DM1-Containing Catabolites Concentrations (in ng/mL) (Nonreducible Thioether Linker [MCC]-DM1 and Lysine [Lys]-MCC-DM1)||Pre-study treatment infusion (0 hr) (infusion duration = 90 min) on Day 1 of Cycle 1 (cycle length = 21 days) in neoadjuvant period; 15-30 min post-study treatment infusion on Day 1 of Cycle 1 and 6 in neoadjuvant and adjuvant period||01/2019||||
647188|NCT02131064|Secondary|Plasma N2'-Deacetyl-N2'-(3-mercapto-1-oxopropyl)-Maytansine (DM1) Concentrations|DM1 is the metabolite of trastuzumab emtansine. Only participants who received trastuzumab emtansine were to be analyzed for this outcome.|Pre-study treatment infusion (0 hr) (infusion duration = 90 min) on Day 1 of Cycle 1 (cycle length = 21 days); 15-30 min post-study treatment infusion on Day 1 of Cycle 1 and 6 in neoadjuvant period|PK population. Overall number of participants analyzed = Participants in PK Population evaluable for this outcome measure. Number Analyzed = participants evaluable for specified category.||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
647189|NCT02131064|Secondary|Cmin of Trastuzumab Emtansine and Total Trastuzumab|Only participants who received trastuzumab emtansine were to be analyzed for this outcome.|Pre-study treatment infusion (0 hr) (infusion duration = 90 min) on Day 1 of Cycle 6 (cycle length = 21 days) in neoadjuvant period|PK population. Overall number of participants analyzed = Participants in PK Population evaluable for this outcome measure. Number Analyzed = participants evaluable for specified category.||mcg/mL||Standard Deviation|Mean
647190|NCT02131064|Secondary|Minimum Observed Serum Concentration (Cmin) of Trastuzumab|Only participants who received trastuzumab were to be analyzed for this outcome.|Pre-study treatment infusion (0 hours [hr]) (infusion duration = 90 min) on Day 1 of Cycle 6 (cycle length = 21 days) in neoadjuvant period|PK population. Overall number of participants analyzed = Number of participants in PK Population with evaluable samples at a given timepoint.||mcg/mL||Standard Deviation|Mean
647191|NCT02131064|Secondary|Cmax of Trastuzumab Emtansine and Total Trastuzumab|Only participants who received trastuzumab emtansine were to be analyzed for this outcome.|15-30 min post-study treatment infusion (infusion duration = 90 min) on Day 1 of Cycle 1 and 6 (each cycle = 21 days) in neoadjuvant period|PK population. Overall number of participants analyzed = Participants in PK Population evaluable for this outcome measure. Number Analyzed = participants evaluable for specified category.||mcg/mL||Standard Deviation|Mean
647192|NCT02131064|Secondary|Maximum Observed Serum Concentration (Cmax) of Trastuzumab|Only participants who received trastuzumab were to be analyzed for this outcome.|15-30 minutes (min) post-study treatment infusion (infusion duration = 90 min) on Day 1 of Cycle 1 and 6 (each cycle = 21 days) in neoadjuvant period|Pharmacokinetic (PK) population:all participants who received at least one dose of T-DM1 (in T-DM1 + P arm) or TCH (in TCH + P arm), and had at least one post-treatment serum sample. Overall number of participants analyzed=Participants in PK Population evaluable for this outcome. Number Analyzed=participants evaluable for specified category.||micrograms per milliliter (mcg/mL)||Standard Deviation|Mean
647193|NCT02131064|Secondary|Percentage of Participants With a Clinically Meaningful Increase in Symptom Subscales|Participants rated their symptoms on EORTC QLQ C-30 and mQLQ-BR23, with total scores ranging from 0 (worst) to 100 (best); where higher score indicates greater degree of symptoms. Clinically meaningful increase in symptoms was defined as an increase in score (deterioration) of 11 points in nausea and vomiting, pain, dyspnea; increase of 9 points in insomnia; increase of 14 points in appetite loss; increase of 15 points in diarrhea, constipation; increase of 10 points in fatigue, systemic therapy side effects, hair loss.|From Baseline (Day 1 Cycle 1) to Cycle 6 (each cycle = 21 days) in neoadjuvant period|ITT population. Participants were analyzed according to their randomized treatment. Overall number of participants analyzed = Number of participants evaluable for this outcome measure. Number Analyzed = participants evaluable for the specified category.||percentage of participants|||Number
647194|NCT02131064|Secondary|Time to Clinically Meaningful Deterioration in Function Subscale|Participants rated their function on EORTC QLQ C-30, with total scores ranging from 0 (worst) to 100 (best); where higher score indicates better functioning. Time to deterioration was defined as the time from baseline to first 10-point (or greater) decrease as measured by physical function; to first 14-point (or greater) decrease as measured by role function, to first 7-point (or greater) decrease as measured by cognitive function. Median time to deterioration was estimated with Kaplan-Meier method. The 95% CI for the median was computed using the method of Brookmeyer and Crowley.|From Baseline (Day 1 Cycle 1) to Cycle 6 (each cycle = 21 days) in neoadjuvant period|ITT population. Participants were analyzed according to their randomized treatment. Overall number of participants analyzed = Number of participants evaluable for this outcome measure.||months||95% Confidence Interval|Median
647195|NCT02131064|Secondary|Percentage of Participants With a Clinically Meaningful Deterioration in Function Subscales|Participants rated their function on EORTC QLQ C-30, with total score and single-item (physical, cognitive and role functioning) scores ranging from 0 (worst) to 100 (best); where higher score indicates better functioning. Clinically meaningful deterioration was defined as a decrease in score of 10 points in physical function; decrease of 7 points in cognitive function and decrease of 14 points in role function.|From Baseline (Day 1 Cycle 1) to Cycle 6 (each cycle = 21 days) in neoadjuvant period|ITT population. Participants were analyzed according to their randomized treatment. Overall number of participants analyzed = Number of participants evaluable for this outcome measure.||percentage of participants|||Number
647196|NCT02131064|Secondary|Time to Clinically Meaningful Deterioration in GHS/QoL Score|Participants rated their quality of life (global health status) on EORTC QLQ C-30, with total scores ranging from 0 (worst) to 100 (best); where higher score indicates better quality of life. Time to deterioration was defined as the time from baseline to first 10-point (or greater) decrease as measured by GHS/QoL. All valid GHS/QoL questionnaires of the neoadjuvant phase including surgery were used. Participants without deterioration were censored at the time of completing the last GHS/QoL plus 1 day. Median time to deterioration was estimated with Kaplan-Meier method. The 95% confidence interval (CI) for the median was computed using the method of Brookmeyer and Crowley.|From Baseline (Day 1 Cycle 1) to Cycle 6 (each cycle = 21 days) in neoadjuvant period|ITT population. Participants were analyzed according to their randomized treatment. Overall number of participants analyzed = Number of participants evaluable for this outcome measure.||months||95% Confidence Interval|Median
647209|NCT02130999|Secondary|Metabolite-to-parent AUC(Inf) Ratios After Oral Administration of a Single 20 mg Dose and IV Administration of a Single 2 mg Dose of Tasimelteon|Comparison of the metabolite-to-parent AUC(inf) ratios for the oral and IV routes.|pre-dose, -0.125, 0, 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose|||metabolite to parent AUC (inf) ratios||Standard Deviation|Mean
647197|NCT02131064|Secondary|Percentage of Participants With a Clinically Meaningful Deterioration in Global Health Status (GHS)/Quality of Life (QoL) Score|Participants rated their quality of life (global health status) on European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ- C30), with total scores ranging from 0 (worst) to 100 (best); where higher score indicates better quality of life. Clinically meaningful deterioration in GHS/QoL was defined as a decrease in score of 10 points in GHS/QoL.|From Baseline (Day 1 Cycle 1) to Cycle 6 (each cycle = 21 days) in neoadjuvant period|ITT population. Participants were analyzed according to their randomized treatment. Overall number of participants analyzed = Number of participants evaluable for this outcome measure.||percentage of participants|||Number
647198|NCT02131064|Secondary|Percentage of Participants by Response for Hair Loss Single Item|Participants answered the Question “Have you lost any hair?”, from the mQLQ-BR23, on a 5-point scale (1 ‘Not at all’, 2 ‘A little’, 3 'Somewhat', 4 ‘Quite a bit’, 5 ‘Very much’). Percentage of participants by each response was reported.|Baseline, Cycle 3, Cycle 5 of neoadjuvant period (each cycle = 21 days); pre-surgery visit (within 6 weeks after neoadjuvant therapy; up to approximately 6 months)|ITT population. Participants were analyzed according to their randomized treatment. Overall number of participants analyzed = participants evaluable for this outcome measure. Number Analyzed = participants evaluable for the specified category. Percentage values are based on ITT N.||percentage of participants|||Number
647199|NCT02131064|Secondary|Percentage of Participants by Response for Skin Problem Single Items|Participants answered the Question 1 “Did itching skin bother you?” and Question 2 “Have you had skin problems?”, from the mQLQ-BR23, on a 5-point scale (1 ‘Not at all’, 2 ‘A little’, 3 'Somewhat', 4 ‘Quite a bit’, 5 ‘Very much’). Percentage of participants by each response was reported.|Baseline, Cycle 3, Cycle 5 of neoadjuvant period (each cycle = 21 days); pre-surgery visit (within 6 weeks after neoadjuvant therapy; up to approximately 6 months)|ITT population. Participants were analyzed according to their randomized treatment. Overall number of participants analyzed = participants evaluable for this outcome measure. Number Analyzed = participants evaluable for the specified category. Percentage values are based on ITT N.||percentage of participants|||Number
647200|NCT02131064|Secondary|Percentage of Participants by Response for Neuropathy Single Item|Participants answered the question “Did you have tingling hands/feet?”, from the Modified Quality of Life Questionnaire Breast Cancer 23 (mQLQ-BR23), on a 5-point scale (1 ‘Not at all’, 2 ‘A little’, 3 'Somewhat', 4 ‘Quite a bit’, 5 ‘Very much’). Percentage of participants by each response was reported.|Baseline, Cycle 3, Cycle 5 of neoadjuvant period (each cycle = 21 days); pre-surgery visit (within 6 weeks after neoadjuvant therapy; up to approximately 6 months)|ITT population. Participants were analyzed according to their randomized treatment. Overall number of participants analyzed = participants evaluable for this outcome measure. Number Analyzed = participants evaluable for the specified category. Percentage values are based on ITT N.||percentage of participants|||Number
647201|NCT02131064|Secondary|Percentage of Participants With Selected Adverse Events (AEs)|Selected AEs included hepatotoxicity, pulmonary toxicity, cardiac dysfunction, neutropenia, thrombocytopenia, peripheral neuropathy, hemorrhage, infusion related reaction (IRR)/hypersensitivity, IRR/Hypersensitivity symptoms, rash, diarrhea and mucositis. An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution.|Neoadjuvant phase (Baseline up to Cycle 6, each cycle = 21 days)|Safety Population comprised all participants who received at least one full or partial dose of any study treatment. Participants were analyzed according to the treatment they actually received.||percentage of participants|||Number
647202|NCT02131064|Secondary|Percentage of Participants Who Received Breast-Conserving Surgery (BCS)|BCS rate was defined as the percentage of participants who achieve BCS out of the ITT population of participants without inflammatory breast cancer.|6 months|A subset of ITT population including participants who had non-inflammatory breast cancer at baseline. Participants were analyzed according to their randomized treatment.||percentage of participants||95% Confidence Interval|Number
647203|NCT02131064|Secondary|Overall Survival|Overall survival is defined as the time from randomization to death from any cause.|From randomization until death (up to approximately 45 months)||01/2019||||
647204|NCT02131064|Secondary|Invasive Disease-free Survival (IDFS)|IDFS is defined only for participants who undergo surgery. Participants who do not undergo surgery will be excluded from the analysis. IDFS is defined as the time from surgery to the first documented occurrence of an IDFS event, defined as: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast as the original primary lesion); Ipsilateral local−regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); Distant recurrence (i.e., evidence of breast cancer, excluding ipsilateral invasive or local-regional breast cancer, in any anatomic site that has been either histologically confirmed or clinically diagnosed as recurrent invasive breast cancer); Contralateral invasive breast cancer; and death from any cause.|From surgery to the first documented occurrence of IDFC event (up to approximately 45 months)||01/2019||||
647205|NCT02131064|Secondary|Event-free Survival (EFS) Assessed by Investigator Based on Radiological, Clinical and Histological Assessment|EFS is defined as the time from randomization to disease progression or disease recurrence (local, regional, distant, or contralateral, invasive or non-invasive), or death from any cause.|From randomization up to disease progression or recurrence or death (up to approximately 45 months)||01/2019||||
647206|NCT02131064|Primary|Percentage of Participants With Total Pathological Complete Response (tpCR) Assessed Based on Tumor Samples|tpCR was assessed by local pathology review on samples taken at surgery following completion of neoadjuvant therapy. tpCR was defined as the absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes ( that is [i.e.], ypT0/is, ypN0 in the American Joint Committee on Cancer [AJCC] staging system, 7th edition). Percentage of participants with tpCR was reported.|Pre-surgery (within 6 weeks after neoadjuvant therapy; up to approximately 6 months)|ITT population. Participants were analyzed according to their randomized treatment.||percentage of participants||95% Confidence Interval|Number
647207|NCT02130999|Other Pre-specified|Number of Participants That Reported Suicidal Ideation, Suicidal Behavior, or Suicide Attempts.|Number of Participants that reported suicidal ideation, suicidal behavior, or suicide attempts per treatment arm and overall.|Baseline to End of Study Day 5 (± 2 days).|||participants|||Number
647210|NCT02130999|Secondary|AUC(Inf) of Tasimelteon’s Metabolites After a Single Oral and I.V. Dose|The mean +/- SD for the AUC(inf) of tasimelteon’s metabolites after a single 20 mg oral dose of tasimelteon and after a single 2 mg I.V. administration of tasimelteon|pre-dose, -0.125, 0, 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose|Only 11 subjects could be analyzed for M11.||h*ng/mL||Standard Deviation|Mean
647211|NCT02130999|Secondary|Cmax of Tasimelteon's Metabolites After an Oral and I.V. Dose of Tasimelteon|The mean +/- SD for the Cmax of tasimelteon’s metabolites after a single 20 mg oral dose of tasimelteon and after a single 2 mg I.V. administration of tasimelteon|pre-dose, -0.125, 0, 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose|||ng/mL||Standard Deviation|Mean
647212|NCT02130999|Secondary|Total Clearance of Tasimelteon After a Single 20 mg Oral Dose and After a Single 2 mg I.V. Administration.|CL of tasimelteon will be compared when given orally or administered as an I.V.|pre-dose, -0.125, 0, 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose|||(mL/min)||Standard Deviation|Mean
647213|NCT02130999|Secondary|T1/2 of Tasimelteon After a Single 20 mg Oral Dose and After a Single 2 mg I.V. Administration.|T1/2 of tasimelteon will be compared when given orally or administered as an I.V.|pre-dose, -0.125, 0, 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours pos-dose|||hour||Standard Deviation|Mean
647214|NCT02130999|Secondary|AUC (Inf) of Tasimelteon After a Single 20 mg Oral Dose and After a Single 2 mg I.V. Administration.|AUC (inf) of Tasimelteon will be compared when given orally or administered as an I.V.|pre-dose, -0.125, 0, 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose|||(h*ng/mL)||Standard Deviation|Mean
647215|NCT02130999|Secondary|Cmax of Tasimelteon After a Single 20 mg Oral Dose and After a Single 2 mg I.V. Administration.|Cmax of tasimelteon will be compared when given orally or administered as an I.V.|pre-dose, -0.125, 0, 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose|||ng/mL||Standard Deviation|Mean
647216|NCT02130999|Primary|Absolute Bioavailability After a Single Oral Dose of Hetlioz™(Tasimelteon) 20mg|The absolute bioavailability (F) of tasimelteon will be estimated from the dose-corrected AUC(inf) after oral and I.V. administration using an analysis of variance (ANOVA) model with treatment, period, sequence, and subject within sequence as the classification variables, using natural log-transformed data. The geometric mean ratio (GMR), oral-to-I.V., and its associated 90% confidence interval (CI) will be used as the estimate of F and its variability.|pre-dose, -0.125, 0, 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose|||Geometric Mean Ratio (%)||90% Confidence Interval|Geometric Mean
647217|NCT02130635|Secondary|Part B: Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) at Screening and Follow-up|FEV1 and FVC are measures of lung function. FEV1 is defined as the maximal amount of air that can be forcefully exhaled in one second. FVC is defined as the maximum amount of air that can be forcibly blown out after a maximum inspiration. FEV1 and FVC measurements were repeated until three technically acceptable measurements (within 150 milliliters of each other) had been made. Only the best of three measurements were recorded.|Screening (up to 30 days prior to Day 1) and Follow-up (approximately Day 19)|Safety Population||Liters||95% Confidence Interval|Mean
647218|NCT02130635|Secondary|Part B: Number of Participants With Normal and Abnormal (Clinically Significant or Not Clinically Significant) Findings in 12-lead Electrocardiogram (ECG) at Any Visit Post-Baseline|Baseline was the Day 1 (pre-dose) measurement. Single 12-lead ECGs were obtained using an ECG machine that automatically calculates the HR and measures PR, QRS, QT, and corrected QT intervals. Day 7 assessments could be conducted on Day 7 or Day 8.|Day 1, Day 7, and Day 14|Safety Population||Participants|||Number
647219|NCT02130635|Secondary|Part B: Number of Participants Meeting Criteria of Potential Clinical Importance for Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), and Heart Rate (HR) at Any Visit Post-Baseline|Baseline was the Day 1 pre-dose measurement. Vital signs (SBP, DBP, and HR) were measured at Day 1 (30 minutes [min] and 6 h post-dose), Day 7 (pre-dose), and Day 14 (24 h post-dose). All measurements were obtained in supine position, after a 5-minute rest. Day 7 assessments could be conducted on Day 7 or Day 8.|Day 1, Day 7, and Day 14|Safety Population||Participants|||Number
647220|NCT02130635|Secondary|Part B: Change From Baseline in Calcium, Potassium, Sodium, Glucose, and Blood Urea Nitrogen (BUN) at the Indicated Time Points|Blood samples were collected for measurement for the indicated tests. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.|Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)|Safety Population||Millimoles per Liter (mmol/L)||Standard Deviation|Mean
647221|NCT02130635|Secondary|Part B: Change From Baseline in Creatinine, Bilirubin, and Total Bilirubin at the Indicated Time Points|Blood samples were collected for measurement for the indicated tests. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.|Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)|Safety Population||Micromoles/Liter (micromol/L)||Standard Deviation|Mean
647222|NCT02130635|Secondary|Part B: Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points|Blood samples were collected for measurement for the indicated tests. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.|Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)|Safety Population||International Units per Liter (IU/L)||Standard Deviation|Mean
647223|NCT02130635|Secondary|Part B: Change From Baseline in Albumin and Total Protein at the Indicated Time Points|Blood samples were collected for measurement for the indicated tests. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.|Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)|Safety Population||g/L||Standard Deviation|Mean
647224|NCT02130635|Secondary|Part B: Change From Baseline in Mean Corpuscle Volume (MCV) at the Indicated Time Points|Blood samples were collected for measurement for the indicated tests. MCV is one of the RBC indices. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.|Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)|Safety Population||fL||Standard Deviation|Mean
647225|NCT02130635|Secondary|Part B: Change From Baseline in Mean Corpuscle Hemoglobin (MCH) at the Indicated Time Points|Blood samples were collected for measurement for the indicated tests. MCH is one of the red blood cell indices. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.|Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)|Safety Population||pg||Standard Deviation|Mean
647226|NCT02130635|Secondary|Part B: Change From Baseline in Hematocrit at the Indicated Time Points|Blood samples were collected for measurement for the indicated tests. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.|Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)|Safety Population||Ratio||Standard Deviation|Mean
647227|NCT02130635|Secondary|Part B: Change From Baseline in Counts of RBCs and Reticulocytes at the Indicated Time Points|Blood samples were collected for measurement for the indicated tests. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.|Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)|Safety Population||10^12 cells/Liter (TI/L)||Standard Deviation|Mean
647228|NCT02130635|Secondary|Part B: Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at the Indicated Time Points|Blood samples were collected for measurement for the indicated tests. MCHC is one of the red blood cell (RBC) indices. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.|Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)|Safety Population||g/L||Standard Deviation|Mean
647229|NCT02130635|Secondary|Part B: Change From Baseline in Counts of Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, White Blood Cells (WBC), Total Neutrophils (Total ANC) at the Indicated Time Points|Blood samples were collected for measurement for the indicated tests. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.|Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)|Safety Population||10^9 cells per liter (GI/L)||Standard Deviation|Mean
647230|NCT02130635|Secondary|Part B: Number of Participants With at Least One Non-serious Adverse Event (AE), Serious Adverse Event (SAE), or Drug-related Adverse Event|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, associated with liver injury and impaired liver function defined as alanine aminotransferase >=3 x upper limit of normal (ULN), and total bilirubin >=2 x ULN or international normalized ratio >1.5. AEs were classified as potentially drug-related, based on the investigator's judgment. Refer to the general AE/SAE module for a list of AEs and SAEs.|From the start of study treatment until follow-up (assessed for approximately 19 days)|Safety Population||Participants|||Number
647231|NCT02130635|Secondary|Part B: Number of Times Rescue Medication Was Used by Participants Daily, During the Treatment Period|Rescue medication was identified from concomitant medication records and the patient diaries which were provided to the participants to record data throughout the treatment period. Only participants who used rescue medication were analyzed. The value NA indicates that the standard deviation could not be calculated as only one participant was analyzed.|Day 1 to Day 15|Safety Population||Number of times||Standard Deviation|Mean
647232|NCT02130635|Secondary|Part B: Trough Concentration (Ctau) of GSK2269577 on Day 7 and Day 15|Blood samples were collected to determine the (trough) plasma concentration of GSK2269577 on Day 7 (pre-dose) and Day 15 (24 hours after dosing on Day 14). Day 7 assessments could be done either on Day 7 or on Day 8.|Day 7 and Day 15|PK Population||pg/mL||95% Confidence Interval|Geometric Mean
647233|NCT02130635|Secondary|Part A: Trough Concentration (Ctau) of GSK2269577 on Day 7 and Day 15|Blood samples were collected to determine the (trough) plasma concentration of GSK2269577 on Day 7 (pre-dose) and Day 15 (24 hours after dosing on Day 14). Day 7 assessments could be done either on Day 7 or on Day 8.|Day 7 and Day 15|PK Population||pg/mL||95% Confidence Interval|Geometric Mean
647234|NCT02130635|Secondary|Part B: Maximum Observed Plasma Concentration (Cmax) of GSK2269577 on Day 7|Blood samples were collected to determine the plasma concentrations of GSK2269577 immediately after dosing on Day 7. Concentration values were log-transformed. Day 7 sampling could be done on Day 7 or Day 8.|Day 7 immediately after dosing|PK Population||pg/mL||95% Confidence Interval|Geometric Mean
647235|NCT02130635|Secondary|Part A: Maximum Observed Plasma Concentration (Cmax) of GSK2269577 on Day 7|Blood samples were collected to determine the plasma concentrations of GSK2269577 immediately after dosing on Day 7. Day 7 sampling could be done on Day 7 or Day 8.|Day 7 immediately after dosing|PK Population||pg/mL||95% Confidence Interval|Geometric Mean
647236|NCT02130635|Secondary|Part B: Day 1 Plasma Concentration of GSK2269577 up to 6 Hours Post Dose|A 2 mL blood sample for pharmacokinetic (PK) analysis was collected at each of the indicated time point. Concentration measurements were log-transformed. Only those participants who were available at the indicated time points were analyzed (represented by n=X,X in the category titles). A value of NA indicates that the geometric mean or 95% confidence interval is not available.|Pre-dose, and 5 min, 30 min, 1 h, 2 h, 4 h, and 6 h post-dose on Day 1|PK Population||pg/mL||95% Confidence Interval|Geometric Mean
647237|NCT02130635|Secondary|Part A: Day 1 Plasma Concentration of GSK2269577 up to 6 Hours Post Dose|A 2 mL blood sample for pharmacokinetic (PK) analysis was collected at each of the indicated time point. Only those participants who were available at the indicated time points were analyzed (represented by n=X in the category titles). A value of NA indicates that the geometric mean or 95% confidence interval is not available.|Day 1 (Pre-dose, 5 min, 30 min, 1, 2, 4 & 6 hours post-dose)|PK Population: participants in the Safety Population for whom a PK sample was obtained and analyzed.||pg/mL||95% Confidence Interval|Geometric Mean
647392|NCT02125877|Secondary|Frequency of Selected Gastro-intestinal (GI) Adverse Events|The percentage of participants with any GI adverse event, diarrhea, constipation, nausea, vomiting, abdominal pain was assessed.|28 weeks|The safety set, which included all participants who received at least one dose of study drug, was analyzed.||Percentage of participants|||Number
647238|NCT02130635|Primary|Part B: Adjusted Median Response of Cytokine (Interleukin 6 [IL6], Interleukin 8 [IL8], Tumor Necrosis Factor Alpha [TNFalpha]) Concentrations in Induced Sputum, on Day 7 and Day 14|This outcome measure was used to estimate the inhibition levels of various doses of GSK2269557 by analyzing inflammatory cytokines IL6, IL8, and TNF alpha using Bayesian methods of statistical analysis, using non-informative prior distributions for all modeling parameters. Posterior medians (adjusted median response) and 95% credible intervals are reported here as medians and 95% confidence intervals respectively. 95% credible interval is reported as 2-sided 95% confidence in the statistical analyses. Day 7 assessments could be conducted on Day 7 or Day 8.|Day 7 (pre-dose) and Day 14 (24 h post-dose)|Safety Population||Picograms/milliliter (pg/mL)||95% Confidence Interval|Median
647239|NCT02130635|Primary|Part A: Change From Baseline in Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) at the Indicated Time Points|Baseline is Day 1 pre-dose. FEV1 and FVC are measures of lung function. FEV1 is defined as the maximal amount of air that can be forcefully exhaled in one second. FVC is defined as the maximum amount of air that can be forcibly blown out after a maximum inspiration. FEV1 and FVC measurements were repeated until three technically acceptable measurements (within 150 milliliters of each other) had been made. Only the best of three measurements were recorded. Baseline was the maximum of the planned pre-dose measurements on Day 1. Change from Baseline at any post-dose time point was calculated as the post-dose value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.|Baseline (Day 1 [pre-dose]), Day 1 (1 h post-dose), Day 7 (pre-dose and 1 h post-dose), and Day 14 (24 h post-dose)|Safety Population||Liters||95% Confidence Interval|Mean
647240|NCT02130635|Primary|Part A: Number of Participants With Normal and Abnormal (Clinically Significant or Not Clinically Significant) Findings in 12-lead Electrocardiogram (ECG) at Any Visit Post-Baseline|Baseline was the Day 1 (pre-dose) measurement. Single 12-lead ECGs were obtained using an ECG machine that automatically calculates the HR and measures PR, QRS, QT, and corrected QT intervals. Clinical significance was judged by the investigator. Day 7 assessments could be conducted on Day 7 or Day 8.|Day 1, Day 7, and Day 14|Safety Population||Participants|||Number
647241|NCT02130635|Primary|Part A: Number of Participants Meeting Criteria of Potential Clinical Importance for Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), and Heart Rate (HR) at Any Visit Post-Baseline|Baseline was the Day 1 pre-dose measurement. Vital signs (SBP, DBP, and HR) were measured at Day 1 (30 minutes [min] and 6 h post-dose), Day 7 (pre-dose), and Day 14 (24 h post-dose). Potential clinical concern range for SBP was <85 millimeters of mercury (mmHg) (low) and >160 mmHg (high), for DBP <45 mmHg (low) and >100 mmHg (high) and for HR <40 bpm and >110 bpm. All measurements were obtained in supine position, after a 5-minute rest. Day 7 assessments could be conducted on Day 7 or Day 8.|Day 1, Day 7, and Day 14|Safety Population||Participants|||Number
647242|NCT02130635|Primary|Part A: Change From Baseline in Calcium, Potassium, Sodium, Glucose, and Blood Urea Nitrogen (BUN) at the Indicated Time Points|Blood samples were collected for measurement for the indicated tests. Baseline is Day 1 pre-dose. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.|Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)|Safety Population||Millimoles per Liter (mmol/L)||Standard Deviation|Mean
647243|NCT02130635|Primary|Part A: Change From Baseline in Creatinine, Bilirubin, and Total Bilirubin at the Indicated Time Points|Blood samples were collected for measurement for the indicated tests. Baseline is Day 1 pre-dose. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.|Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)|Safety Population||Micromoles/Liter (micromol/L)||Standard Deviation|Mean
647244|NCT02130635|Primary|Part A: Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points|Blood samples were collected for measurement for the indicated tests. Baseline is Day 1 pre-dose. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.|Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)|Safety Population||International Units per Liter (IU/L)||Standard Deviation|Mean
647245|NCT02130635|Primary|Part A: Change From Baseline in Albumin and Total Protein at the Indicated Time Points|Blood samples were collected for measurement for the indicated tests. Baseline is Day 1 pre-dose. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.|Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)|Safety Population||g/L||Standard Deviation|Mean
647246|NCT02130635|Primary|Part A: Change From Baseline in Mean Corpuscle Volume (MCV) at the Indicated Time Points|Blood samples were collected for measurement for the indicated tests. Baseline is Day 1 pre-dose. MCV is one of the RBC indices. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.|Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)|Safety Population||Femtoliters (fL)||Standard Deviation|Mean
647247|NCT02130635|Primary|Part A: Change From Baseline in Mean Corpuscle Hemoglobin (MCH) at the Indicated Time Points|Blood samples were collected for measurement for the indicated tests. Baseline is Day 1 pre-dose. MCH is one of the red blood cell indices. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.|Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)|Safety Population||Picograms (pg)||Standard Deviation|Mean
647248|NCT02130635|Primary|Part A: Change From Baseline in Counts of RBCs and Reticulocytes at the Indicated Time Points|Blood samples were collected for measurement for the indicated tests. Baseline is Day 1 pre-dose. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.|Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)|Safety Population||10^12 cells/Liter (TI/L)||Standard Deviation|Mean
647293|NCT02130193|Primary|Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) in Part A|12-lead ECG was taken on Day 1 pre-dose and on Follow-up visit (Day 21 to 28) in Part A using an ECG machine. Triplicate reading were taken on Day 1 pre-dose. Participants with abnormal-clinically not significant (NCS) and abnormal-clinically significant (CS) findings were sumarized.|Up to Day 28 in Part A|ITT Population||Participants|||Number
647249|NCT02130635|Primary|Part A: Change From Baseline in Hematocrit at the Indicated Time Points|Blood samples were collected for measurement for the indicated tests. Baseline is Day 1 pre-dose. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.|Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)|Safety Population||Ratio||Standard Deviation|Mean
647250|NCT02130635|Primary|Part A: Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at the Indicated Time Points|Blood samples were collected for measurement for the indicated tests. Baseline is Day 1 pre-dose. MCHC is one of the red blood cell (RBC) indices. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.|Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 h post-dose)|Safety Population||Grams/Liter (g/L)||Standard Deviation|Mean
647251|NCT02130635|Primary|Part A: Change From Baseline in Counts of White Blood Cells (WBC), Total Neutrophils (Total Absolute Neutrophil Count [ANC]), Lymphocytes, Monocytes, Eosinophils, Basophils, and Platelets at the Indicated Time Points|Blood samples were collected for measurement for the indicated tests. Baseline is Day 1 pre-dose. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.|Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)|Safety Population||10^9 cells per liter (GI/L)||Standard Deviation|Mean
647252|NCT02130635|Primary|Part A: Number of Participants With at Least One Non-serious Adverse Event (AE), Serious Adverse Event (SAE), or Drug-related Adverse Event|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, associated with liver injury and impaired liver function defined as alanine aminotransferase >=3 x upper limit of normal (ULN), and total bilirubin >=2 x ULN or international normalized ratio >1.5. AEs were classified as potentially drug-related, based on the investigator's judgment. Refer to the general AE/SAE module for a list of AEs and SAEs.|From the start of study treatment until follow-up (assessed for approximately 19 days)|Safety Population: all participants who received at least one dose of study treatment.||Participants|||Number
647253|NCT02130284|Other Pre-specified|Device Metric/Performance - All Device Deficiencies||From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures|||device performance issues|||Number
647254|NCT02130284|Other Pre-specified|Sensor Performance: Accuracy|MARD (Mean Absolute Relative Difference) between sensor glucose value and YSI. MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100).|From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures|Total of 71 subjects completed the study. However, two subjects who withdrew also had YSI and Sensor glucose values. Therefore, total of 73 subjects contributed to sensor accuracy analysis||percentage||Standard Deviation|Mean
647255|NCT02130284|Other Pre-specified|PLGM Performance - Hypoglycemia Event Rate at Threshold of YSI <= 65 mg/dL.|Hypoglycemic event rate among 71 subjects who underwent the PLGM experiment. Hypoglycemic events are defined based on: occurrence of 2 or more continuous YSI <= 65 mg/dL during in-clinic procedures.|From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures|Two subjects were excluded from analysis because the site staff did not set the pump up correctly prior to YSI and the PLGM feature was never set to activate.||percentage of total subjects|||Number
647256|NCT02130284|Primary|Rescue Events During In-clinic Procedues||From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures|||Participants|||Count of Participants
647257|NCT02130284|Primary|Diabetic Ketoacidosis|Evaluation of DKA during in-clinic procedures|From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures|||Participants|||Count of Participants
647258|NCT02130284|Primary|Severe Hypoglycemia|Evaluation of incidence of severe hypoglycemia during in-clinic procedures|From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures|||Participants|||Count of Participants
647259|NCT02130284|Primary|Unanticipated Device Effect (UADE)|Evaluation of incidence of UADE during in-clinic procedures|From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures|||Participants|||Count of Participants
647260|NCT02130284|Primary|Serious Adverse Events (SAE)|Evaluation of incidence of SAE during in-clinic procedures|From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures|||Participants|||Count of Participants
647261|NCT02130193|Secondary|Number of Participants With Patient Global Impression of Change (PGIC)Score in Part B|Participants completed a PGIC questions at Week 4, 8, 16, 24, 40 and 52. Response options were on a 7 point Likert scale ranging from much better to much worse. PGIC was re-coded from a categorical to numerical value prior to analysis as: much worse = -3, worse = -2, slightly worse = -1, no change = 0, slightly better = 1, better = 2, much better = 3.A categorical summary of PGIC is presented by treatment and visit.Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to Day 392 in Part B|ITT Population||Participants|||Number
647262|NCT02130193|Secondary|Number of Participants With Patient Global Rating of Severity (PGRS) Score in Part B|PGRS is a single global question and was asked to participants to rate their COPD severity on a four point scale ranging from 1-4 (1=mild, 2=moderate, 3=severe, 4=very severe). Participants completed PGRS at Week 0, 4, 8, 16, 24, 40 and 52. Baseline was considered as score on Day 1. A categorical summary of PGRS is presented by treatment and visit.Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to Day 392 in Part B|ITT Population||Participants|||Number
651409|NCT02029521|Secondary|Forced Vital Capacity|Percent predicted of forced vital capacity.|6 months|PFT's not done on children under age of 5.||Percent Predicted||Standard Deviation|Mean
647263|NCT02130193|Secondary|Number of Participants With Physician’s Global Assessment (PGA) Readings in Part B|The PGA is a single item clinician reported outcome measure assessing the overall severity of COPD. Physicians rated disease severity on a four point scale ranging from 1-4 (1=mild, 2=moderate, 3=severe, 4=very severe) at Week 0, 4, 8, 16, 24, 40 and 52. Baseline was considered as score on Day 1. A categorical summary of PGA is presented by treatment and visit.Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to Day 392 in Part B|ITT Population||Participants|||Number
647264|NCT02130193|Secondary|Change From Baseline for COPD Assessment Test (CAT) at the Indicated Time Points in Part B|The CAT is a validated, 8 item questionnaire which has been developed designed to measure overall COPD-related health status for the initial assessment and longitudinal follow up of par. with COPD. Participants completed each question by rating their experience on a 6 point scale ranging from 0 (no impairment) to 5 (maximum impairment) with a total scoring range of 0 - 40. CAT was assessed at Baseline (Day 1), Day 28, Day 112, Day 168, Day 280 and Day 364 where Baseline was considered as score on Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to Day 392 in Part B|ITT Population||Score on a scale||Standard Deviation|Mean
647265|NCT02130193|Secondary|Monthly Weighted Means of EXACT-RS Domain Scores in Part B|EXACT-RS is a tool which consists of 11 items from the 14 item EXACT-PRO instrument, intended to capture information related to the respiratory symptoms of COPD. EXACT-RS domains included breathlessness, cough and chest symptoms. The EXACT-RS has a scoring range of 0-40, higher scores indicate more severe symptoms. A par. had at least 10 days of diary data in any month to contribute a non-missing weighted mean AUC of daily values; otherwise the weighted mean for that month were considered missing. A mixed effects model in a Bayesian framework with repeated measures were performed. The posterior mean and corresponding 95 percent credible interval were calculated. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to Day 392 in Part B|ITT Population||Score on a scale||Standard Deviation|Mean
647266|NCT02130193|Secondary|Assessment of Severity of EXACT-PRO Events in Part B|EXACT-PRO tool was used to measure severity of COPD exacerbations in participants. Severity was indicated by the maximum EXACT-PRO total score during the course of event (from day of onset to day of recovery).|Up to Day 392 in Part B|ITT Population||Score on a scale||Standard Deviation|Mean
647267|NCT02130193|Secondary|Assessment of Duration of EXACT-PRO Events in Part B|Duration is the length of time in days from onset to recovery. It was calculated as the difference in days between day of onset and day of recovery. Onset of event was identified as either an increase in EXACT-PRO score of >=12 points above the par. current mean Baseline for 2 consecutive days, with Day 1 of the 2 days serving as Day 1 onset of the event, or an increase of >=9 points above the par. current mean Baseline for 3 consecutive days, with Day 1 of the 3 days serving as Day 1 onset of the event. Duration was 3-day rolling average was used, which was initiated on Day 1 of onset and ended on Day 1 of Recovery. Recovery was defined as the first day in which par. experienced a persistent, sustained improvement in their condition i.e. decrease in the rolling average EXACT-PRO total score >=9 point from the maximum observed value (highest rolling average EXACT-PRO total score observed the first 14 days of the event) during the first 14 days of an event that is sustained for 7 days.|Up to Day 392 in Part B|ITT Population||Days||Standard Deviation|Mean
647268|NCT02130193|Secondary|Time to First EXACT-PRO Event in Part B|The hazard ratio for the DNX versus placebo comparison, along with 95% credible interval and posterior probability was derived and a Bayesian Cox proportional hazards model was used for statistical analysis. The analysis was performed on ITT Population. One participant was excluded from analysis.|Up to Day 392 in Part B|ITT Population||Days||Standard Deviation|Mean
647269|NCT02130193|Secondary|Time to First HCRU COPD Exacerbation in Part B|HCRU COPD exacerbations are defined as moderate or severe exacerbations based on requirement of new prescription antibiotics or oral corticosteroids, hospitalization or emergency room visits for management of COPD exacerbation. The time to the first on-treatment HRCU exacerbation were summarized by treatment group. It was analyzed using a Bayesian Cox proportional hazards model. The hazard ratio for the danirixin vs. placebo comparison, along with 95 percent credible interval, was derived, with terms for treatment group, smoking status and country. Posterior probabilities of the ratio of the percentage of par. with an HCRU exacerbation, adjusted for time to first exacerbation, in the danirixin group relative to the placebo group were calculated. 1 par. was excluded from analysis.|Up to Day 392 in Part B|ITT Population||Days||Standard Deviation|Mean
647270|NCT02130193|Secondary|Monthly Weighted Means of Exacerbations of EXACT-PRO Total Score in Part B|EXACT-PRO is a 14 item patient reported outcome instrument designed to capture information on the occurrence, frequency, severity, and duration of COPD exacerbations. The total score for EXACT-PRO ranges from 0-100, higher scores indicate more severe symptoms. A par. had at least 10 days of diary data in any month to contribute a non-missing weighted mean AUC of daily values; otherwise the weighted mean for that month were considered missing. A mixed effects model in a Bayesian framework with repeated measures were performed on the EXACT-PRO monthly weighted mean AUC data. The posterior mean and corresponding 95 percent credible interval were calculated. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to Day 392 in Part B|ITT Population||Score on a scale||Standard Deviation|Mean
647271|NCT02130193|Secondary|Number of EXACT-PRO Exacerbations Per Year in Part B|EXACT-PRO is a 14 item patient reported outcome instrument designed to capture information on the occurrence, frequency, severity, and duration of COPD exacerbations. The total score for EXACT-PRO ranges from 0-100, higher scores indicate more severe symptoms. For par. with less than 364 days on-treatment, the annual exacerbation rate was imputed as the number of recorded on-treatment exacerbations, divided by the number of 4-week treatment period intervals for which the par. was in the study, multiplied by 13. For par. with 364 or more days on-treatment, the annual exacerbation rate was calculated as the number of recorded exacerbations between study days 1 and 364. Statistical analysis was done using a Bayesian Cox model, assuming a negative binomial distribution for the underlying exacerbation rate. The exacerbation rates and the ratio (danirixin/placebo), were estimated and 95 percent credible intervals were produced using non-informative priors. 1 par. was excluded from analysis.|Up to Day 392 in Part B|ITT Population||Exacerbations per year||Standard Deviation|Mean
651410|NCT02029521|Secondary|Bacteriology|Expectorated sputum or throat swab|3 months|||participants|||Number
647272|NCT02130193|Secondary|AUC(0-12) of Danirixin in Part B|AUC (0-12) of danirixin was derived from the PK samples collected at pre-dose and at 0.5, 1, 2, 4, 6, 8, 10 and 12 hour post-dose on Day 1 and Day 364; and at pre-dose and 2 hours on Day 28, 56 and 168 in Part B. PK analysis of danirixin was conducted by non-compartmental methods. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Pre-dose and at 0.5, 1, 2, 4, 6, 8, 10 and 12 hour post-dose on Day 1 and Day 364; and at pre-dose and 2 hours on Day 28, 56 and 168 in Part B|PK Population||Hour*ng/mL||95% Confidence Interval|Geometric Mean
647273|NCT02130193|Secondary|Tmax of Danirixin in Part B|Tmax of danirixin was derived from the PK samples collected at pre-dose and at 0.5, 1, 2, 4, 6, 8, 10 and 12 hour post-dose on Day 1 and Day 364; and at pre-dose and 2 hours on Day 28, 56 and 168 in Part B. PK analysis of danirixin was conducted by non-compartmental methods. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Pre-dose and at 0.5, 1, 2, 4, 6, 8, 10 and 12 hour post-dose on Day 1 and Day 364; and at pre-dose and 2 hours on Day 28, 56 and 168 in Part B|PK Population||Hour||Full Range|Median
647274|NCT02130193|Secondary|Cmax of Danirixin in Part B|Cmax of danirixin was derived from the PK samples collected at pre-dose and at 0.5, 1, 2, 4, 6, 8, 10 and 12 hour post-dose on Day 1 and Day 364; and at pre-dose and 2 hours on Day 28, 56 and 168 in Part B. PK analysis of danirixin was conducted by non-compartmental methods. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Pre-dose and at 0.5, 1, 2, 4, 6, 8, 10 and 12 hour post-dose on Day 1 and Day 364; and at pre-dose and 2 hours on Day 28, 56 and 168 in Part B|PK Population||ng/mL||95% Confidence Interval|Geometric Mean
647275|NCT02130193|Primary|Monthly Weighted Means of Exacerbations of Chronic Pulmonary Disease Tool-respiratory Symptoms (EXACT-RS) Total Score in Part B|EXACT-RS is a tool which consists of 11 items from the 14 item EXACT- patient reported outcomes (EXACT-PRO) instrument, intended to capture information related to the respiratory symptoms of COPD, i.e. breathlessness, cough, sputum production, chest congestion and chest tightness. The EXACT-RS has a scoring range of 0-40, higher scores indicate more severe symptoms. A par. had at least 10 days of diary data in any month to contribute a non-missing weighted mean AUC of daily values; otherwise the weighted mean for that month were considered missing. A mixed effects model in a Bayesian framework with repeated measures were performed on the EXACT-RS monthly weighted mean AUC data. The posterior mean and corresponding 95 percent credible interval were calculated. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to Day 392 in Part B|ITT Population||Score on a scale||Standard Deviation|Mean
647276|NCT02130193|Primary|Number of Health Care Resource Utilization (HCRU) Defined COPD Exacerbations Per Year in Part B|HCRU COPD exacerbations are defined as moderate or severe exacerbations based on requirement of new prescription antibiotics or oral corticosteroids, hospitalization or emergency room visits for management of COPD exacerbation. For par. with less than 364 days on-treatment, the annual exacerbation rate was imputed as the number of recorded on-treatment exacerbations, divided by the number of 4-week treatment period intervals for which the par. was in the study, multiplied by 13. For par. with 364 or more days on-treatment, the annual exacerbation rate was calculated as the number of recorded exacerbations between study days 1 and 364. Statistical analysis was done using a Bayesian Cox model, assuming a negative binomial distribution for the underlying exacerbation rate. The exacerbation rates along with the ratio (danirixin/placebo), were estimated and corresponding 95 percent credible intervals were produced using non-informative priors. 1 par. was excluded from the analysis.|Up to Day 392 in Part B|ITT Population||Exacerbations per year||Standard Deviation|Mean
647277|NCT02130193|Primary|Area Under the Blood Concentration-time Curve (AUC) Over Dosing Interval (AUC[0-12]) of Danirixin in Part A|AUC (0-12) of danirixin was derived from the PK samples collected at pre-dose and at 0.5, 1, 2, 4, 6, 8, 10 and 12 hour post-dose on Day 1 and Day 14 in Part A. PK analysis of danirixin was conducted by non-compartmental methods. A Bayesian random effects model was performed adjusting for the trial as a random effect. A non-informative normal prior distribution was used. Point estimates and corresponding 90 percent credible intervals were constructed.|Pre-dose and at 0.5, 1, 2, 4, 6, 8, 10 and 12 hour post-dose on Day 1 and Day 14 in Part A|PK Population||Hour*ng/mL||95% Confidence Interval|Geometric Mean
647278|NCT02130193|Primary|Time of Occurrence of Cmax (Tmax) of Danirixin in Part A|Tmax of danirixin was derived from the PK samples collected at pre-dose and at 0.5, 1, 2, 4, 6, 8, 10 and 12 hour post-dose on Day 1 and Day 14 in Part A. PK analysis of danirixin was conducted by non-compartmental methods.|Pre-dose and at 0.5, 1, 2, 4, 6, 8, 10 and 12 hour post-dose on Day 1 and Day 14 in Part A|PK Population||Hour||Full Range|Median
647279|NCT02130193|Primary|Maximum Observed Plasma Concentration (Cmax) of Danirixin in Part A|Cmax of danirixin was derived from the Pharmacokinetics (PK) samples collected at pre-dose and at 0.5, 1, 2, 4, 6, 8, 10 and 12 hour post-dose on Day 1 and Day 14 in Part A. PK analysis of danirixin was conducted by non-compartmental methods. PK Concenteration Population comprised of par. in the ITT Population and who had provided at least one on-treatment blood sample for determination of danirixin concentration.|Pre-dose and at 0.5, 1, 2, 4, 6, 8, 10 and 12 hour post-dose on Day 1 and Day 14 in Part A|PK Population||Nanogram per milliliter (ng/mL)||95% Confidence Interval|Geometric Mean
647280|NCT02130193|Primary|Change From Baseline in FEV1 and FVC at the Indicated Time Points in Part B|FEV1 and FVC were performed at Screening and on Day 1, 28, 56, 112, 168, 280, 364 and at Follow-up (Day 378 to 392) in Part B. FEV1 and FVC assessments at each time point (post-bronchodilator) were taken in triplicate. The maximum of the triplicate assessments were used. Baseline was considered as the measurement obtained at Day 1 pre-dose. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. Statistical analysis was performed using a repeated measures mixed effects model in a Bayesian framework. The estimate of the treatment difference and corresponding 95 percent credible interval was constructed for the difference between danirixin and placebo for each visit. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to Day 392 in Part B|ITT Population||Liter||Standard Deviation|Mean
647346|NCT02127892|Other Pre-specified|Number of Participants With Veno-occlusive Disease (VOD) - Moderate and Severe|Evaluation of veno-occlusive disease determined by the presence of the following features; fluid retention, weight gain, leaky capillary syndrome, painful liver enlargement, refractoriness to platelet tranfusion and hyperbilirubinemia|100 days|||Participants|||Count of Participants
647281|NCT02130193|Primary|Change From Baseline in Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) at the Indicated Time Points in Part A|FEV1 measures how much air a person can exhale during a forced breath in 1 second. FVC is the total amount of air exhaled during the FEV test. FEV1 and FVC were performed at Screening and on Day 1, 14 and at Follow-up visit (Day 21 to 28). FEV1 and FVC assessments at each time point (post-bronchodilator) were taken in triplicate. The maximum of the triplicate assessments were used. Baseline was considered as the measurement obtained at Day 1 pre-dose. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.|Up to Day 28 in Part A|ITT Population||Liter||Standard Deviation|Mean
647282|NCT02130193|Primary|Change From Baseline in Urine Specific Gravity of Urine in Part B|Urinalysis including urine specific gravity was done at Screening and on Day 28, 168 and 364 in Part B. Baseline was considered as the measurement obtained at Screening (Day -1). The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.|Up to Day 392 in Part B|ITT Population||urine specific gravity||Standard Deviation|Mean
647283|NCT02130193|Primary|Change From Baseline in Urine Specific Gravity of Urine in Part A|Urinalysis including urine specific gravity was done at Screening and Day 14 in Part A. Baseline was considered as the measurement obtained at Screening (Day -1). The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.|Up to Day 28 in Part A|ITT Population||urine specific gravity||Standard Deviation|Mean
647284|NCT02130193|Primary|Change From Baseline in Urine pH in Part B|Urinalysis including urine pH was done at Screening and on Day 28, 168 and 364 in Part B. Baseline was considered as the measurement obtained at Screening (Day -1). The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to Day 392 in Part B|ITT Population||pH||Standard Deviation|Mean
647285|NCT02130193|Primary|Change From Baseline in Urine Power of Hydrogen (pH) at Day 14 in Part A|Urinalysis including urine pH was done at Screening and Day 14 in Part A. Baseline was considered as the measurement obtained at Screening (Day -1). The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.|Up to Day 28 in Part A|ITT Population||pH||Standard Deviation|Mean
647286|NCT02130193|Primary|Number of Participants With Urinalysis Dipstick Results in Part B|Test strip urinalysis was done for glucose, ketones, occult blood and protein at Screening and on Day 28, 168, 224 and 364 in Part B. Results were presented as negative, trace, 1+, 2+ and 3+ for glucose, ketones, occult blood and protein. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to Day 392 in Part B|ITT Population||Participants|||Number
647287|NCT02130193|Primary|Number of Participants With Urinalysis Dipstick Results in Part A|Test strip urinalysis was done for glucose, ketones, occult blood and protein at Screening and Day 14 in Part A. Results were presented as negative, trace, 1+, 2+ and 3+ for glucose, ketones, occult blood and protein. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Up to Day 28 in Part A|ITT Population||Participants|||Number
647288|NCT02130193|Primary|Number of Participants With Clinical Chemistry Values of Potential Clinical Importance in Part B|Blood samples were collected at Screening and on Day 28, 168 and 364 in Part B to evaluate clinical chemistry parameters which included ALT, albumin, ALP, AST, total bilirubin, calcium, bicarbonate, chloride, creatinine, direct bilirubin, GGT, glucose, potassium, total protein, sodium, BUN and uric acid. Clinical chemistry values of potential clinical importance were presented as 'High' or 'Low' values based on the reference laboratory standards. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to Day 392 in Part B|ITT Population||Participants|||Number
647289|NCT02130193|Primary|Number of Participants With Clinical Chemistry Values of Potential Clinical Importance in Part A|Blood samples were collected at Screening and Day 14 in Part A to evaluate clinical chemistry parameters which included alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), total bilirubin, calcium, bicarbonate, chloride, creatinine, direct bilirubin, gamma glutamyl transferase (GGT), glucose, potassium, total protein, sodium, blood urea nitrogen (BUN) and uric acid. Additional liver monitoring chemistry (ALT, AST, ALP and total and direct bilirubin) was done on Day 1 pre-dose. Clinical chemistry values of potential clinical importance were presented as 'High' or 'Low' values based on the reference laboratory standards.|Up to Day 28 in Part A|ITT Population||Participants|||Number
647290|NCT02130193|Primary|Number of Participants With Hematology Values of Potential Clinical Importance in Part B|Blood samples were collected at Screening and on Day 28, 168, and 364 in Part B to evaluate hematology parameters which included hemoglobin, hematocrit, basophils, eosinophils, lymphocytes, monocytes, neutrophils, MCHC, MCH, MCV, RBC count, WBC count, platelet count and reticulocyte count. Hematology values of potential clinical importance were presented as 'High' or 'Low' values based on the reference laboratory standards. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to Day 392 in Part B|ITT Population||Participants|||Number
647291|NCT02130193|Primary|Number of Participants With Hematology Values of Potential Clinical Importance in Part A|Blood samples were collected at Screening and Day 14 in Part A to evaluate hematology parameters which included hemoglobin, hematocrit, basophils, eosinophils, lymphocytes, monocytes, neutrophils, mean corpuscular hemoglobin concentration (MCHC), mean corpuscular hemoglobin (MCH), mean corpuscular volume (MCV), red blood cell (RBC) count, white blood cell (WBC) count, platelet count and reticulocyte count. Hematology values of potential clinical importance were presented as 'High' or 'Low' values based on the reference laboratory standards.|Up to Day 28 in Part A|ITT Population||Participants|||Number
647292|NCT02130193|Primary|Number of Participants With Abnormal 12-lead ECG in Part B|12-lead ECG was taken on Day 1 pre-dose and on Day 28, 168 and at Follow-up (Day 378 to 392) in Part B using an ECG machine. Participants with abnormal-NCS and abnormal-CS findings were sumarized. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to Day 392 in Part B|ITT Population||Participants|||Number
647347|NCT02127892|Secondary|Number of Participants With Donor-derived CD3+ T Lymphocytes >/= 100/mm3|Absolute number of donor-derived CD3+ T lymphocytes >/= 100/mm3 in participating subjects.|1 year|||Participants|||Count of Participants
647294|NCT02130193|Primary|Number of Participants With Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Pulse Rate and Respiratory Rate Abnormalities of Potential Clinical Importance in Part B|Vital signs including SBP, DBP, pulse rate and respiratory rate were taken on Day 1 pre-dose and on Day 28, 56, 112, 168, 280, 364 and at Follow-up (Day 378 to 392) in Part B. Measurements were obtained in a semi-supine/ supine position after 5 minutes rest. The mean of replicate assessments at any given time point was used as the value for that time point. SBP <90 or >160 mmHg, DBP <40 or >110 mmHg, pulse rate <35 or >120 bpm and respiratory rate <8 or >30 breaths per minute were considered as values of potential clinical importance and were presented as 'High' or 'Low' values. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to Day 392 in Part B|ITT Population||Participants|||Number
647295|NCT02130193|Primary|Number of Participants With Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Pulse Rate, Respiratory Rate and Body Temperature Abnormalities of Potential Clinical Importance in Part A|Vital signs including SBP, DBP, pulse rate, respiratory rate and body temperature were taken on Day 1 pre-dose and on Day 14 and at Follow-up (Day 21 to 28) in Part A. Measurements were obtained in a semi-supine/ supine position after 5 minutes rest. The mean of replicate assessments at any given time point was used as the value for that time point. SBP <90 or >160 millimeter of mercury (mmHg); DBP <40 or >110 mmHg, pulse rate <35 or >120 beats per minute (bpm) and respiratory rate <8 or >30 breaths per minute were considered as values of potential clinical importance and were presented as 'High' or 'Low' values. Intent-to-Treat (ITT) Population comprised of all randomized par. who received at least one dose of study medication.|Up to Day 28 in Part A|ITT Population||Participants|||Number
647296|NCT02130193|Primary|Number of Participants With Any AE and SAE in Part B|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention, events associated with liver injury and impaired liver function were categorized as SAE. Participants with AE or SAE occurrences >= 5 percent were summarized.|Up to Day 392 in Part B|All Subjects Population||Participants|||Number
647297|NCT02130193|Primary|Number of Participants With Any Adverse Event (AE) and, Serious Adverse Event (SAE) in Part A|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention, events associated with liver injury and impaired liver function were categorized as SAE. Participants with any AE or SAE were summarized. Participants with AE or SAE occurrences >= 5 percent were summarized. All Subjects Population comprised of all participants who were screened and for whom a record existed on the study database.|Up to Day 28 in Part A|All Subjects Population||Participants|||Number
647298|NCT02129777|Secondary|Mean Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Weeks 2, 4, 6, 10, and 12|The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lunula, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis.|Baseline, Weeks 2, 4, 6, 10, and 12|FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.||units on a scale||Standard Error|Least Squares Mean
647299|NCT02129777|Secondary|Change From Baseline in EQ-5D-VAS Score at Week 12|EQ-5D-VAS is a participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (“Worst imaginable health state”) to 100 mm (“Best imaginable health state”); higher scores indicate a better health state.|Baseline, Week 12|FAS where baseline and Week 12 assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.||millimeter (mm)||Standard Error|Least Squares Mean
647300|NCT02129777|Secondary|Change From Baseline in EuroQoL Health Questionnaire (EQ-5D)- Index Score at Week 12|EQ-5D-Index score is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The score ranges from -0.594 to 1.000. The higher score indicates a better health state perceived by the participant.|Baseline, Week 12|FAS where baseline and Week 12 assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.||units on a scale||Standard Error|Least Squares Mean
647301|NCT02129777|Secondary|Change From Baseline in Short Form 36 Health Survey (SF-36) at Week 12|SF-36 is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects are summarized as physical and mental health summary scores. The score range for the physical and mental health scores is 0-100 (100=highest level of functioning).|Baseline, Week 12|FAS where baseline and Week 12 assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.||units on a scale||Standard Error|Least Squares Mean
647348|NCT02127892|Primary|Number of Participants With Engraftment|Engraftment is defined as recovery of blood counts (neutrophil and platelet engraftment) with cells of donor origin, documented by either bone marrow or peripheral blood chimerism assays after hematopoietic stem cell transplant.|100 day|||Participants|||Count of Participants
647302|NCT02129777|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 12|The DLQI is a 10-point rating scale for determining the impact of dermatological conditions on the participant’s quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). Maximum total score is 30, where 0-1 represents “No effect at all on participant's life” and 21-30 “Extremely large effect on participant's life” - higher scores indicating poorer quality of life.|Baseline, Week 12|FAS where baseline and Week 12 assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.||units on a scale||Standard Error|Least Squares Mean
647303|NCT02129777|Secondary|Change From Baseline in Duration of Morning Stiffness at Weeks 2, 4, 6, 10, and 12|Assessments were performed using a portable electronic device, which was kept and used by the participant throughout the duration of the study. Duration of stiffness was elicited in response to a standard question included in the portable device.|Baseline, Weeks 2, 4, 6, 10, and 12|FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.||minutes||Standard Error|Least Squares Mean
647304|NCT02129777|Secondary|Change From Baseline in VAS Morning Stiffness Score at Weeks 2, 4, 6, 10, and 12|Assessments were performed using a portable electronic device, which was kept and used by the participant throughout the duration of the study. Participants were asked to indicate their level of morning stiffness by marking a horizontal line with “No stiffness” at the left extreme and “Very severe stiffness” at the right extreme (scale ranging from 0 - 10, but not shown on the line). Each assessment was intended to capture the severity of stiffness experienced by the participant since waking on that particular day.|Baseline, Weeks 2, 4, 6, 10, and 12|FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.||units on a scale||Standard Error|Least Squares Mean
647305|NCT02129777|Secondary|Change From Baseline in VAS Joint Pain Score at Weeks 2, 4, 6, 10, and 12|Assessments were performed using a portable electronic device, which was kept and used by the participant throughout the duration of the study. Participants were asked to indicate their severity of joint pain by marking a horizontal line with “No pain” at the left extreme and “Worst pain imaginable” at the right extreme (scale ranging from 0 - 10, but not shown on the line). Each assessment was intended to capture the severity of pain experienced during the previous 24 hours.|Baseline, Weeks 2, 4, 6, 10, and 12|FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.||units on a scale||Standard Error|Least Squares Mean
647306|NCT02129777|Secondary|Change From Baseline in Visual Analogue Scale (VAS) Itching Score at Weeks 2, 4, 6, 10, and 12|Assessments were performed using a portable electronic device, which was kept and used by the participant throughout the duration of the study. Participants were asked to indicate their level of itching by marking a horizontal line with “No itch” at the left extreme and “Worst itch imaginable” at the right extreme (scale ranging from 0 - 10, but not shown on the line). Each assessment was intended to capture the severity of itching experienced during the previous 24 hours.|Baseline, Weeks 2, 4, 6, 10, and 12|FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.||units on a scale||Standard Error|Least Squares Mean
647307|NCT02129777|Secondary|Change From Baseline in Affected Body Surface Area (BSA) at Weeks 2, 4, 6, 10, and 12|Assessment of BSA with psoriasis was performed by means of the palm method, where the palm of the participant’s hand represented 1% of BSA. The affected areas were then calculated by their size compared to the participant’s palm.|Baseline, Weeks 2, 4, 6, 10, and 12|FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.||percentage of total body surface area||Standard Error|Least Squares Mean
647308|NCT02129777|Secondary|Change From Baseline in sPGA Score at Weeks 2, 4, 6, 10, and 12|sPGA for psoriasis is scored on a 6-point scale, reflecting a global consideration of the erythema, plaque elevation and skin scaling across all psoriatic lesions. sPGA of psoriasis scale ranges from 0 (clear) to 5 (very severe).|Baseline, Weeks 2, 4, 6, 10, and 12|FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.||units on a scale||Standard Error|Least Squares Mean
647309|NCT02129777|Secondary|Percentage of Participants Achieving a sPGA Response of Clear (0) or Almost Clear (1) at Weeks 2, 4, 6, 10 and 12|sPGA for psoriasis is scored on a 6-point scale, reflecting a global consideration of the erythema, plaque elevation and skin scaling across all psoriatic lesions. sPGA of psoriasis scale ranges from 0 (clear) to 5 (very severe). ‘Clear’ and 'Almost clear’ included all participants who had scored a 0 or 1.|Weeks 2, 4, 6, 10 and 12|FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.||percentage of participants|||Number
647310|NCT02129777|Secondary|Percentage of Participants Achieving Greater Than or Equal to (>=) 2 Point Improvement From Baseline in Static Physicians Global Assessment (sPGA) Score at Weeks 2, 4, 6, 10 and 12|sPGA for psoriasis is scored on a 6-point scale, reflecting a global consideration of the erythema, plaque elevation and skin scaling across all psoriatic lesions. sPGA of psoriasis scale ranges from 0 (clear) to 5 (very severe). Participants who had >=2 point improvement are reported.|Weeks 2, 4, 6, 10 and 12|FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.||percentage of participants|||Number
647349|NCT02127567|Secondary|Average Score for Completeness of Reporting of Essential Elements|Completeness of reporting scores calculated based on essential elements to report, on a scale from 0 to 10, 0 being the lowest and10 the highest|one time four hour writing session|||units on a scale|Participants|Standard Deviation|Mean
647350|NCT02127567|Secondary|The Score for Completeness of Reporting for Trial Design|on a scale from 0 to 10, 0 being the lowest and 10 the highest|one time measure after a four-hour writing session|||units on a scale|Participants|Standard Deviation|Mean
647311|NCT02129777|Secondary|Percentage of Participants Achieving 90 Percent Reduction From Baseline PASI Score (PASI90 Response) at Weeks 2, 4, 6, 10 and 12|PASI is an assessment of psoriasis lesion severity and affected body area combined into single score. The body was divided into 4 sections: head (h), trunk (t), upper (u) and lower (l) extremities. For each section, percent body surface area (A) involved was estimated: 0= No involvement to 6= 90–100 percent (%). Severity was estimated by clinical signs: erythema (E), induration (I), and desquamation (D); scale: 0= no symptoms to 4= very marked. Final PASI = 0.1(Eh + Ih + Dh)Ah + 0.3(Et + It + Dt)At + 0.2(Eu + Iu + Du)Au + 0.4(El + Il + Dl)Al where head: 0.1, upper extremities (arms): 0.2, trunk: 0.3, lower extremities (legs): 0.4 (corresponding to approximately 10%, 20%, 30%, and 40% of body surface area, respectively); total possible score range: 0= no disease to 72= maximal disease. Participants showing at least 90% reduction in PASI score relative to baseline PASI Score are reported.|Weeks 2, 4, 6, 10 and 12|FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.||percentage of participants|||Number
647312|NCT02129777|Secondary|Percentage of Participants Achieving 50 Percent Reduction From Baseline PASI Score (PASI50 Response) at Weeks 2, 4, 6, 10 and 12|PASI is an assessment of psoriasis lesion severity and affected body area combined into single score. The body was divided into 4 sections: head (h), trunk (t), upper (u) and lower (l) extremities. For each section, percent body surface area (A) involved was estimated: 0= No involvement to 6= 90–100 percent (%). Severity was estimated by clinical signs: erythema (E), induration (I), and desquamation (D); scale: 0= no symptoms to 4= very marked. Final PASI = 0.1(Eh + Ih + Dh)Ah + 0.3(Et + It + Dt)At + 0.2(Eu + Iu + Du)Au + 0.4(El + Il + Dl)Al where head: 0.1, upper extremities (arms): 0.2, trunk: 0.3, lower extremities (legs): 0.4 (corresponding to approximately 10%, 20%, 30%, and 40% of body surface area, respectively); total possible score range: 0= no disease to 72= maximal disease. Participants showing at least 50% reduction in PASI score relative to baseline PASI Score are reported.|Weeks 2, 4, 6, 10 and 12|FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.||percentage of participants|||Number
647313|NCT02129777|Secondary|Change From Baseline in PASI Score at Weeks 2, 4, 6, 10, and 12|PASI is an assessment of psoriasis lesion severity and affected body area combined into single score. The body was divided into 4 sections: head (h), trunk (t), upper (u) and lower (l) extremities. For each section, percent body surface area (A) involved was estimated: 0= No involvement to 6= 90–100 percent (%). Severity was estimated by clinical signs: erythema (E), induration (I), and desquamation (D); scale: 0= no symptoms to 4= very marked. Final PASI = 0.1(Eh + Ih + Dh)Ah + 0.3(Et + It + Dt)At + 0.2(Eu + Iu + Du)Au + 0.4(El + Il + Dl)Al where head: 0.1, upper extremities (arms): 0.2, trunk: 0.3, lower extremities (legs): 0.4 (corresponding to approximately 10%, 20%, 30%, and 40% of body surface area, respectively); total possible score range: 0= no disease to 72= maximal disease.|Baseline, Weeks 2, 4, 6, 10, and 12|FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.||units on a scale||Standard Error|Least Squares Mean
647314|NCT02129777|Secondary|Percentage of Participants Achieving 75 Percent Reduction From Baseline PASI Score (PASI75 Response) at Weeks 2, 4, 6, and 10|PASI is an assessment of psoriasis lesion severity and affected body area combined into single score. The body was divided into 4 sections: head (h), trunk (t), upper (u) and lower (l) extremities. For each section, percent body surface area (A) involved was estimated: 0= No involvement to 6= 90–100 percent (%). Severity was estimated by clinical signs: erythema (E), induration (I), and desquamation (D); scale: 0= no symptoms to 4= very marked. Final PASI = 0.1(Eh + Ih + Dh)Ah + 0.3(Et + It + Dt)At + 0.2(Eu + Iu + Du)Au + 0.4(El + Il + Dl)Al where head: 0.1, upper extremities (arms): 0.2, trunk: 0.3, lower extremities (legs): 0.4 (corresponding to approximately 10%, 20%, 30%, and 40% of body surface area, respectively); total possible score range: 0= no disease to 72= maximal disease. Participants showing at least 75% reduction in PASI score relative to baseline PASI Score are reported.|Weeks 2, 4, 6 and 10|FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.||percentage of participants|||Number
647315|NCT02129777|Primary|Percentage of Participants Achieving 75 Percent Reduction From Baseline Psoriasis Area and Severity Index (PASI) Score (PASI75 Response) at Week 12|PASI is an assessment of psoriasis lesion severity and affected body area combined into single score. The body was divided into 4 sections: head (h), trunk (t), upper (u) and lower (l) extremities. For each section, percent body surface area (A) involved was estimated: 0= No involvement to 6= 90–100 percent (%). Severity was estimated by clinical signs: erythema (E), induration (I), and desquamation (D); scale: 0= no symptoms to 4= very marked. Final PASI = 0.1(Eh + Ih + Dh)Ah + 0.3(Et + It + Dt)At + 0.2(Eu + Iu + Du)Au + 0.4(El + Il + Dl)Al where head: 0.1, upper extremities (arms): 0.2, trunk: 0.3, lower extremities (legs): 0.4 (corresponding to approximately 10%, 20%, 30%, and 40% of body surface area, respectively); total possible score range: 0= no disease to 72= maximal disease. Participants showing at least 75% reduction in PASI score relative to baseline PASI Score are reported.|Week 12|Full analysis set (FAS) where baseline and Week 12 assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.||percentage of participants|||Number
647316|NCT02129725|Primary|Insulin-stimulated AKT Phosphorylation|"measured using Western blot for pAkt and for total Akt from muscle biopsies obtained at the end of the baseline hyperinsulinemic clamp and the three-month hyperglycemic clamp.
The ratio of pAkt to Akt expression was calculated at each time point and the change in ratio from 0 to 3 months is presented."|3 months|||change in ratio||Standard Deviation|Mean
647317|NCT02129608|Primary|Change in Weight|The change in weight from baseline to 3 months|3 months|||kg||Standard Deviation|Mean
647318|NCT02129608|Primary|Change in Waist Circumference|The change in waist circumference from baseline to 3 months|3 months|||cm||Standard Deviation|Mean
647351|NCT02127567|Secondary|The Score for Completeness of Reporting for Outcomes|on a scale from 0 to 10, 0 being the lowest and 10 the highest|one time measure after a four-hour writing session|||units on a scale|Participants|Standard Deviation|Mean
647352|NCT02127567|Secondary|The Score for Completeness of Reporting for Interventions|on a scale from 0 to 10, 0 being the lowest and 10 the highest|one time measure after a four-hour writing session|||units on a scale|Participants|Standard Deviation|Mean
647319|NCT02129192|Secondary|Area Under the Concentration-time Curve (AUC 0-infinity) of the Analytes in Plasma Over the Time Interval From 0 to Extrapolated Infinity After Single Administration of T80/A5/H12.5 mg FDC Tablet|Area under the concentration-time curve (AUC 0-infinity) of telmisartan, amlodipine and HCTZ in plasma over the time interval from 0 to extrapolated infinity after single administration of T80/A5/H12.5 mg FDC tablet|3 hours (h) pre drug admin and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug admin, in addition 15min, 30min, 45min, 1h 30min, 2h 30min for telmisartan and HCTZ only, 72h for telmisartan and amlodipine only and 96h, 120h, 144h for amlodipine only|FEAS||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
647320|NCT02129192|Secondary|Area Under the Concentration-time Curve (AUC 0-infinity) of the Analytes in Plasma Over the Time Interval From 0 to Extrapolated Infinity|Area under the concentration-time curve (AUC 0-infinity) of telmisartan, amlodipine and HCTZ in plasma over the time interval from 0 to extrapolated infinity|3 hours (h) pre drug admin and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug admin, in addition 15min, 30min, 45min, 1h 30min, 2h 30min for telmisartan and HCTZ only, 72h for telmisartan and amlodipine only and 96h, 120h, 144h for amlodipine only|PKS||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
647321|NCT02129192|Primary|Area Under the Concentration-time Curve (AUC 0-tz) of the Analytes in Plasma Over the Time Interval From 0 to the Last Quantifiable Plasma Concentration After Single Administration of T80/A5/H12.5 mg FDC Tablet|Area under the concentration-time curve (AUC 0-tz) of telmisartan, amlodipine and HCTZ in plasma over the time interval from 0 to the last quantifiable plasma concentration after single administration of T80/A5/H12.5 mg FDC tablet|3 hours (h) pre drug admin and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug admin, in addition 15min, 30min, 45min, 1h 30min, 2h 30min for telmisartan and HCTZ only, 72h for telmisartan and amlodipine only and 96h, 120h, 144h for amlodipine only|FEAS||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
647322|NCT02129192|Primary|Area Under the Concentration-time Curve (AUC 0-tz) of the Analytes in Plasma Over the Time Interval From 0 to the Last Quantifiable Plasma Concentration|Area under the concentration-time curve (AUC 0-tz) of telmisartan, amlodipine and HCTZ in plasma over the time interval from 0 to the last quantifiable plasma concentration|3 hours (h) pre drug admin and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug admin, in addition 15min, 30min, 45min, 1h 30min, 2h 30min for telmisartan and HCTZ only, 72h for telmisartan and amlodipine only and 96h, 120h, 144h for amlodipine only|PKS||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
647323|NCT02129192|Primary|Maximum Measured Concentration (Cmax) of the Analytes in Plasma After Single Administration of T80/A5/H12.5 mg FDC Tablet|Maximum measured concentration (Cmax) of telmisartan, amlodipine and HCTZ in plasma after single oral administration of T80/A5/H12.5 mg FDC tablet|3 hours (h) pre drug admin and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug admin, in addition 15min, 30min, 45min, 1h 30min, 2h 30min for telmisartan and HCTZ only, 72h for telmisartan and amlodipine only and 96h, 120h, 144h for amlodipine only|Food effect analysis set (FEAS) which included healthy subjects of treatment sequence TRRTT in the TS who were judged appropriate to continue to period 5 by the investigator, had evaluable PK variables for both feeding conditions and did not have an important protocol violation relevant to relative bioavailability evaluation.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
647324|NCT02129192|Primary|Maximum Measured Concentration (Cmax) of the Analytes in Plasma|Maximum measured concentration (Cmax) of telmisartan, amlodipine and HCTZ in plasma|3 hours (h) pre drug admin and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug admin, in addition 15min, 30min, 45min, 1h 30min, 2h 30min for telmisartan and HCTZ only, 72h for telmisartan and amlodipine only and 96h, 120h, 144h for amlodipine only|Pharmacokinetic set (PKS) which included all healthy subjects in the TS who had evaluable PK variables for both treatments (i.e. had data of at least one analyte for both test and reference products) in periods 1, 2, 3 and 4. Subjects who had an important protocol violation relevant to PK evaluation were to be excluded from the PKS.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
647325|NCT02129062|Primary|Overall Survival Time|The time measurement from beginning treatment to recurrent or progressive disease is objectively documented. Overall survival time will be estimated using the Kaplan-Meier method. The two-sided log-rank test will be used to assess the differences of time to events between groups such as age groups, or Philadelphia chromosome-positive versus Philadelphia chromosome-negative B-ALL. Progressive disease is defined as a doubling of the peripheral blasts and an absolute increase of > 5 x 10^9/L.|Up to thirty days after after completion of study treatment anticipated to be 12 weeks for total of 16 weeks|Study terminated early due to slow enrollment, insufficient data . One participant was not evaluable due to early death, other two participants were removed from the study within 30 days of study start due to disease progression prior to scheduled treatment evaluations.|||||
647326|NCT02129062|Primary|Objective Response Rate (ORR)|ORR is defined as the proportion of participants with complete or partial response. Response definitions of Complete Response (CR): disappearance of leukemia as indicated by <5% marrow blasts & absence of peripheral blood leukemic blasts, with recovery of hematopoiesis defined by absolute neutrophil count (ANC) >1000/μL & platelets >100,000/μL. C1 extramedullary disease status required. CR with incomplete count recovery (CRi): CR except with ANC <1000/μL and/or platelets <100,000/μL. Partial response (PR): improved or no worsening of ALL as indicated by no peripheral blood blasts, neutrophils >1000/μL, platelets >100,000μL, and either or both of the following: >50% decrease in marrow blast percentage, compared to pretreatment value, & marrow blast percentage ≥ 5% and ≤ 25%. C2 extramedullary disease status. Treatment failures are defined as participants who fail to achieve CR, CRi or PR.|3 months after treatment|One of three participants was not evaluable for response.||percentage of participants|||Number
647327|NCT02128919|Other Pre-specified|Change From Baseline in Psychiatric Symptoms|The Positive and Negative Syndrome Scale (PANSS) was used to measure psychiatric symptoms. Item scores ranged from 1 (Absent) to 6 (Severe) for symptoms on the Positive Scale (total subscale range: 7-42), the Negative Scale (total subscale range: 7-42), and the General Psychopathology Scale (total subscale range:16-96). All three subscales were summed for the PANSS total score (total scale range: 30-180). Scores closer to 30 after baseline represented better outcomes. Here we report difference scores from post-treatment and baseline with negative difference scores representing better outcomes.|Baseline and after 5 tDCS sessions|||Units on a scale||Standard Deviation|Least Squares Mean
647353|NCT02127567|Secondary|The Score for Completeness of Reporting for Participants|on a scale from 0 to 10, 0 being the lowest and 10 the highest|one time measure after a four-hour writing session|||units on a scale|Participants|Standard Deviation|Mean
647328|NCT02128919|Secondary|Change From Baseline in Cognitive Performance|The MATRICS Consensus Cognitive Battery (MCCB) was used to measure cognitive performance. Seven Domain scores and a Composite score are calculated by the proprietary MCCB Computer Scoring Program from raw scores on 10 individually administered subtests. We used the revised MCCB program (beta version) which allows for calculation of Domain and Composite scores with missing data. The Domain T-scores are percentile-ranked and range from <20 (<0.1 percentile) to >80 (>99.9 percentile). The Composite scores are also percentile-ranked and range from <213 (T<20, <0.1 percentile) to >487 (T>80, >99.9 percentile). Higher scores after baseline represent better outcomes. Here we report difference scores from post-treatment and baseline with positive difference scores representing better outcomes.|Baseline and 1-3 days (mean 1.8 [SD 1.4] days after 5 tDCS sessions( mean 8.7 days after baseline)|||MATRICS domain difference scores||Standard Deviation|Least Squares Mean
647329|NCT02128919|Primary|Change From Baseline in Cigarette Craving|"The Brief Questionnaire on Smoking Urges (QSU-Brief) was used to measure cigarette cravings. Scores ranged from a minimum of 1 (Strongly Disagree) to a maximum of 7 (Strongly Agree) and were determined by self-reported responses to 10 statements about having cravings for smoking. Scores closer to 1 after treatment would indicate a better outcome. Responses to each of the 10 items in the scale were summed for one total score. With 10 items on this scale with a range of scores from 1 to 7, on each occasion of rating the minimum score would be 7 and the maximum score would be 70."|Baseline and after 5 tDCs sessions (mean time 8.7[SD 2.7] days after basleine)|Findings are based on31 subjects (15 active tDCS and 16 sham tDCS) who completed this QSU-Brief questionnaire in at baseline and after 5 tDCS sessions.. Complete sample who entered study and were randomized were 33 subjects 24 male and 9 female, but all subjects did not complete QSU brief rating scale..||Units on QSU-Brief Scale||Standard Error|Least Squares Mean
647330|NCT02128867|Other Pre-specified|Sa02|SaO2 will be measured during 15 minutes of treatment time|15 minutes||||||
647331|NCT02128867|Other Pre-specified|Heartrate|heartrate will be measured during 15 min of treatment time|15 minutes||||||
647332|NCT02128867|Secondary|Duration of Reflux Episodes|duration of reflux episodes will be measured during 15 min of treatment time|15 minutes||||||
647333|NCT02128867|Primary|Number of Refluxes|number of refluxes will be counted over a period of 15 minutes ( treatment time )|15 minutes|||number of refluxes||Standard Deviation|Mean
647334|NCT02128542|Secondary|Number of Participants With Nonstructural Protein 5B (NS5B) Nucleoside Inhibitor (NI) Resistance-Associated Variants (RAVs) and RBV RAVs at Pretreatment and Posttreatment|Deep sequencing of the HCV NS5B gene was attempted for all participants who had virologic failure at pretreatment and posttreatment time points if the level of HCV RNA in the plasma sample was ≥ 1000 IU/L.|Pretreatment and Posttreatment Week 12|Participants who relapsed and qualified for sequencing analysis were analyzed.||participants|||Number
647335|NCT02128542|Secondary|Percentage of Participants Experiencing Viral Relapse|Viral relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period after having achieved HCV RNA < LLOQ at end of treatment.|Up to Posttreatment Week 12|Participants in the Full Analysis Set with available data were analyzed||Percentage of participants|||Number
647336|NCT02128542|Secondary|Percentage of Participants Experiencing Viral Breakthrough|"Viral breakthrough was defined as either:
HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment
HCV RNA ≥ LLOQ at the last available on-treatment measurement with no subsequent follow-up values"|Up to Posttreatment Weak 12|Full Analysis Set||Percentage of participants|||Number
647337|NCT02128542|Secondary|Percentage of Participants With Sustained Virologic Response at 4 Weeks After Discontinuation of Therapy (SVR4)|SVR4 was defined as HCV RNA < LLOQ at 4 weeks following the last dose of study drug.|Posttreatment Week 4|Full Analysis Set||percentage of participants||95% Confidence Interval|Number
647338|NCT02128542|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 12 weeks|Safety Analysis Set: participants who received at least 1 dose of study drug||Percentage of participants|||Number
647339|NCT02128542|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug||Percentage of participants||95% Confidence Interval|Number
647340|NCT02128490|Secondary|Percentage of Participants With Serum Urate <6.0 mg/dL at Month 3||Month 3|FAS included all participants who were randomized and received at least 1 dose of double-blind study medication. Participants who discontinued double-blind study drug prior to the Month 3 visit were considered treatment failures, i.e. to have serum urate ≥ 5.0 mg/dL.||percentage of participants|||Number
647341|NCT02128490|Secondary|Percentage of Participants With at Least One Gout Flare Requiring Treatment|"A participant was considered to have a gout flare if the following criteria were met:
Participant-reported acute particular pain typical of a gout attack that was deemed by participant and/or investigator to require treatment and was treated with colchicine, nonsteroidal anti-inflammatory drugs (NSAIDs) or steroids, Participant experienced at least 3 or more of: 1) Joint swelling, 2) Redness, 3) Tenderness, 4) Pain, Participant experienced at least one or more of: 1) Rapid onset of pain, 2) Decreased range of motion, 3) Joint warmth, 4) Other symptoms similar to a prior gout flare."|Baseline to Month 3|FAS included all participants who were randomized and received at least 1 dose of double-blind study medication.||percentage of participants|||Number
647342|NCT02128490|Primary|Percentage of Participants With Serum Urate <5.0 mg/dL at Month 3||Month 3|Full Analysis Set (FAS) included all participants who were randomized and received at least 1 dose of double-blind study medication. Participants who discontinued double-blind study drug prior to the Month 3 visit were considered treatment failures, i.e. to have serum urate ≥ 5.0 mg/dL.||percentage of participants|||Number
647343|NCT02128269|Primary|Safety and Tolerability of Intravenous (IV) ALXN1007 as Measured by Percentage of Patients Reporting Adverse Events||Treatment Period (24 weeks)|||Participants|||Count of Participants
647344|NCT02127892|Other Pre-specified|Overall Survival|Overalls survival of patient at 1 year post transplant|1 year|||Participants|||Count of Participants
647345|NCT02127892|Other Pre-specified|Number of Participants With Graft Versus Host Disease (GVHD) - Grade III or IV|GVHD disease surveillance done by clinical evaluation, to include history, physical examination, specifically for rash, jaundice, liver dysfunction, nausea and vomiting, diarrhea and failure to thrive.|1 year|||Participants|||Count of Participants
647357|NCT02127372|Primary|Phase II - Radiographic Response|"The percentage of patients with a complete or partial response.
Responses for the Phase II portion of the trial will be by Response Evaluation Criteria In Solid Tumors (RECIST) criteria as follows:
Complete Response (CR): disappearance of all target lesions; Partial Response (PR): at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD."|After Cycle 6, approximately 18 weeks.|||percentage of participants||95% Confidence Interval|Number
647358|NCT02127372|Secondary|Change in Gd-MRI Measurement|The change in Gd-MRI perfusion/permeability measurement between pre and post 7-day of STI571 treatment.|Day 7|Because the study was terminated prior to completion, correlative studies were not run.|||||
647359|NCT02127372|Secondary|Phase 2: 1 Year Survival|Phase II: Percentage of patients alive 1 year from the start of protocol treatment.|1 year|||percentage of participants||95% Confidence Interval|Number
647360|NCT02127372|Primary|Phase 1 - Maximum Tolerated Dose (MTD) of Docetaxel and Cisplatin|To determine the maximum tolerated dose (MTD) of STI571, docetaxel, and cisplatin when administered in combination for the treatment of patients with chemo-naïve recurrent and metastatic (stage IV) NSCLC.|After cycle 1, day 22|One patient only received the lead-in dose of STI571 prior to withdrawing from the study without a DLT. This subject is not included in the DLT determination.||mg/m2|||Number
647361|NCT02127372|Primary|Phase 1 - Maximum Tolerated Dose (MTD) of STI571|To determine the maximum tolerated dose (MTD) of STI571, docetaxel, and cisplatin, when administered in combination for the treatment of patients with chemo-naïve recurrent and metastatic (stage IV) NSCLC.|After cycle 1, day 22|One patient only received the lead-in dose of STI571 prior to withdrawing from the study without a DLT. This subject is not included in the DLT determination.||mg|||Number
647362|NCT02127307|Primary|Relationship Between the Occurrence of Death and 123I-mIBG Uptake on Planar Scintigraphy With Heart to Mediastinum (H/M) Ratio of <1.60 vs H/M ≥1.60|H/M ratio for 123I-mIBG uptake at 3 hours 50 minutes post administration was calculated by dividing the counts/pixel in the total myocardium region of interest (ROI) by the counts/pixel in the 7x7 pixel mediastinal ROI. H/M ratios were categorized as ‘Low’ and ‘High’ based on being <1.6 or ≥1.6 respectively. The efficacy of 123I-mIBG was based on the prognostic value of the imaging data, as reflected by the H/M ratio, for identifying HF participants at lower risk of death during 60 months of follow-up.|From the date of administration of 123I-mIBG in studies MBG-311 or MBG-312 up to 60 months|Efficacy population was 961 participants who received investigational medicinal product (IMP) and had a diagnostic 3 hour 50 minute planar image in MBG311 or MBG312. Here, 'n' signifies number of participants with available data for specified category.||number of death or other adverse events|||Number
647363|NCT02126839|Secondary|Summary of Participants With Adverse Events|"Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator as mild (no limitation of usual activities), moderate, or severe (inability to carry out usual activities).
Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes."|6 Months|Safety Analysis set includes all participants who receive at least 1 dose of study drug. In this population, treatment is assigned based upon the treatment participants actually receive, regardless of the treatment to which they were randomized.||participants|||Number
647364|NCT02126839|Secondary|Baseline Adjusted Peak Expiratory Flow (PEF) Area Under The Concentration Time Curve Up From Time Zero up to 6 Hours (AUC0-6) Over 3 Weeks|Serial PEF measurements were obtained via spirometry. PEF measures for purpose of serial PEF assessment (pre and postdose) were collected from the spirometer assessed PEF, utilizing the values from the efforts selected based on the highest of 3 acceptable FEV1 maneuvers.|30 ±5 and 5 ±2 minutes prior to dosing, and at 5 ±2, 15 ±5, 30 ±5, 45 ±5, 60 ±10, 120 ±10, 240 ±10, and 360 ±10 minutes after completion of dosing on Days 1 and 22|Full analysis set||Liters/min*hour||Standard Error|Least Squares Mean
647365|NCT02126839|Primary|Baseline Adjusted Percent Predicted Forced Expiratory Volume In 1 Second (FEV1) Area Under The Concentration Time Curve Up From Time Zero up to 6 Hours (AUC0-6) Over 3 Weeks|Following measurement of the baseline FEV1 and dose administration on Days 1 and 22, FEV1 values (highest of 3 acceptable maneuvers) will be obtained at 5 (±2), 15 (±5), 30 (±5), 45 (±5), 60 (±10), 120 (±10), 240 (±10), and 360 (±10) minutes after the completion of dosing. Predicted FEV1 values were computed and adjusted for age, height, and gender according to Eigen et al (Eigen et al 2001) for participants 4 to 5 years of age and to Quanjer et al (Quanjer et al 1995) for participants aged 6 to 11 years using ATS criteria (American Thoracic Society/European Respiratory Society Statement 2007).|30 ±5 and 5 ±2 minutes prior to dosing, and at 5 ±2, 15 ±5, 30 ±5, 45 ±5, 60 ±10, 120 ±10, 240 ±10, and 360 ±10 minutes after completion of dosing on Days 1 and 22|The full analysis set (FAS) includes all participants in the ITT population who receive at least 1 dose of study medication and have at least 1 postbaseline assessment of the primary endpoint.||% predicted FEV1/hour||Standard Error|Least Squares Mean
647366|NCT02126748|Secondary|Oxygen Saturation (SaO2)|oxygen saturation (SaO2) measured by pulse -oximetry|before, after and 1h after treatment||||||
647367|NCT02126748|Secondary|Heartrate||before, after and 1h after intervention||||||
647368|NCT02126748|Secondary|Wang Score||before treatment, immediately after treatment and 1h after treatment||||||
647369|NCT02126748|Primary|Length of Hospital Stay|Previously publised data ( Luo et al. 2011) showed that the average hospital stay for infants with acute viral bronchiolitis, inhaling 4 ml NaCl3%, three times /day is 6 days ( SD 1,2)|6 days|||days||Standard Deviation|Mean
647370|NCT02126670|Secondary|Irritation Score|Percentage of participants with moderate or severe overall irritation at end of treatment.|up to Day 57|Overall irritation||percentage of participants|||Number
647371|NCT02126670|Primary|Treatment Success at End of Study Visit|Treatment success at end of study visit defined as % of participants with 100% clearance of AK lesions|up to Day 57|Per protocol||percentage of participants||95% Confidence Interval|Number
655247|NCT01953328|Secondary|Percent Change From Baseline in Triglycerides at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
647372|NCT02126319|Primary|Pca Related Intrusive Ideation|Intrusive ideation related to prostate cancer risk was assessed using the Impact of Events Scale (IES) (Horowitz et al., 1979). The full scale consists of two subscales, intrusive ideation and avoidant ideation but only the intrusive ideation subscale was used in the present study. The instrument has been used extensively in the cancer literature (Schwartz et al., 2002). Cronbach’s alpha for the intrusion subscale in the present study was 0.82. Values range from zero to 35, with higher values indicating higher level of intrusive ideation. Because of high skewness, a median split was used to create a high intrusive ideation group and a low intrusive ideation group.|Six months|||units on a scale||Standard Deviation|Mean
647373|NCT02126319|Primary|Negative Expectations Regarding Pca Risk|Negative expectations related to Pca risk screening comprised five items and assessed the costs and risks of screening, in terms of time and effort, fears of discrimination, insurance and employment, and financial concerns on a five-point scale (e.g., “Screening may have a negative impact on my health insurance”). Questionnaire items were author-constructed, based on our prior work and cognitive-affective theory (Miller et al., 1996). Reported means are based on a scale from one to five (average of five items). Cronbach’s alpha for the scale was 0.80. A higher score indicates more negative expectations.|Six months|||units on a scale||Standard Deviation|Mean
647374|NCT02126319|Primary|Pca-related Positive Expectations|Positive expectations regarding the effects of screening were assessed using two items on a five-point scale (“Regular screening will ensure that I stay healthy” and “Regular screening will prolong my life”). Questionnaire items were author-constructed, based on our prior work and cognitive-affective theory (Miller et al., 1996). Reported means are based on a scale from one to five (average of the two items). Cronbach’s alpha for the scale was 0.76. Higher score indicates more positive expectations.|six months|||units on a scale||Standard Deviation|Mean
647375|NCT02126319|Primary|Pca Perceived Risk|Perceived risk of Pca was assessed using four items where participants were asked to estimate their prostate cancer risk in general (e.g., “Do you feel as though you are the kind of person who is likely to develop prostate cancer?”) or comparing themselves to other men at risk for Pca (e.g., “Given your ethnicity, what are your chance of getting prostate cancer?”) on a five-point scale (Lerman et al., 1996). Reported means are based on a scale from one to five (based on the average of the four items). Cronbach’s alpha for the scale was 0.83. A higher score indicates higher Pca perceived risk.|six months|||units on a scale||Standard Deviation|Mean
647376|NCT02126319|Primary|Pca Risk-related Knowledge|Knowledge about Pca risk was measured using an eight item scale prepared for this study. It consisted of true/false items [e.g., “An abnormal digital rectal examination (DRE) and/or prostate-specific antigen (PSA) could be the result of conditions other than prostate cancer”]. Correct responses received a value of one, whereas false responses received a zero. Values ranged between zero and eight. Higher score means better knowledge of risk and issues.|six months|||units on a scale||Standard Deviation|Mean
647377|NCT02126319|Primary|Pca Related Intrusive Ideation|Intrusive ideation related to prostate cancer risk was assessed using the Impact of Events Scale (IES) (Horowitz et al., 1979). The full scale consists of two subscales, intrusive ideation and avoidant ideation. In this study only the intrusive ideation subscale was used. The instrument has been used extensively in the cancer literature (Schwartz et al., 2002). Values range from 0 to 35, with higher values indicating a higher level of intrusive ideation. Cronbach’s alpha for the intrusion subscale in the present study was 0.82. Because of high skewness, a median split was used to create a high intrusive ideation group and a low intrusive ideation group.|three weeks|||units on a scale||Standard Deviation|Mean
647378|NCT02126319|Primary|Negative Expectations Regarding Pca Risk|Negative expectations related to Pca screening comprised five items and assessed the costs and risks of screening, in terms of time and effort, fears of discrimination, insurance and employment, and financial concerns on a five-point scale (e.g., “Screening may have a negative impact on my health insurance”). Questionnaire items were author-constructed, based on our prior work and cognitive-affective theory (Miller et al., 1996). Reported means are based on a scale from one to five (average of five items). Cronbach’s alpha for the scale was 0.80. A higher score indicates more negative expectations.|three weeks|||units on a scale||Standard Deviation|Mean
647379|NCT02126319|Primary|Pca-related Positive Expectations|Positive expectations regarding the effects of screening were assessed using two items on a five-point scale (“Regular screening will ensure that I stay healthy” and “Regular screening will prolong my life”). Questionnaire items were author-constructed, based on our prior work and cognitive-affective theory (Miller et al., 1996). Reported means are based on a scale from one to five (average of the two items). Cronbach’s alpha for the scale was 0.76. Higher score indicates more positive expectations.|three weeks|||units on a scale||Standard Deviation|Mean
647380|NCT02126319|Primary|Pca Perceived Risk|Perceived risk of Pca was assessed using four items where participants were asked to estimate their prostate cancer risk in general (e.g., “Do you feel as though you are the kind of person who is likely to develop prostate cancer?”) or comparing themselves to other men at risk for Pca (e.g., “Given your ethnicity, what are your chance of getting prostate cancer?”) on a five-point scale (Lerman et al., 1996). Reported means are based on a scale from one to five (based on the average of the four items). Cronbach’s alpha for the scale was 0.83. A higher score indicates higher Pca perceived risk.|three weeks|||units on a scale||Standard Deviation|Mean
647381|NCT02126319|Primary|Pca Risk-related Knowledge|Knowledge about Pca risk was measured using an eight item scale prepared for this study. It consisted of true/false items [e.g., “An abnormal digital rectal examination (DRE) and/or prostate-specific antigen (PSA) could be the result of conditions other than prostate cancer”]. Correct responses received a value of one, whereas false responses received a zero. Values ranged between zero and eight. Higher score means better knowledge of risk and issues.|three weeks|||units on a scale||Standard Deviation|Mean
647393|NCT02125877|Primary|Overall Safety as Measured by Changes in Laboratory Values From Baseline|The percentage of participants with post-baseline laboratory values meeting specified criteria for notable/extended range was assessed. The following laboratory parameters were measured: platelet count, absolute neutrophils, serum creatinine , creatinine clearance, urinary protein/urinary creatinine ratio, alanine aminotransferase (ALT) and aspartate aminotransferase (AST). Note that within data categories, creat = creatinine, cons = consecutive, ULN = upper limit of normal and urin = urinary.|baseline (BL), 30 weeks|The safety set, which included all participants who received at least one dose of study drug, was analyzed.||Percentage of participants|||Number
647382|NCT02126306|Primary|Number of Participants With a Decrease of 2 Points in the Non-Alcoholic Fatty Liver Disease Activity Score (NAS) Analysis is Per Protocol|"Number of Participants who had a decrease of 2 points in the Non-Alcoholic Fatty Liver Disease Activity Score (NAS) from baseline at 40 weeks per protocol analysis. The score is performed on the liver biopsy before and after treatment. The total score is used with a range from 4-16. A decrease in the total score by 2 points or more is considered an improvement, while an increase in the total score by 2 points or more is considered deterioration. No use of subscales for the data analysis was made.
Allparticipants in both arms who showed a decrease of 2 points or more in the Non-Alcoholic Fatty Liver Disease Activity Score are conisdered as responders. Only values quantifying data that were actually measured and analyzed are included."|Total score from baseline compared with week 40.|||participants|||Number
647383|NCT02125877|Secondary|Dererasirox Plasma Concentration|Blood samples were collected to assess deferasirox concentration. Dose-adjusted calculations are presented: (concentration/actual dose)*20 for participants on DFX-DT and (concentration/actual dose)*14 for participants on DFX-FCT.|Week 3, day 1, pre-dose (0 hour (h)) and 2 h post-dose; week 13, day 1, pre-dose (0 hour (h)) and 2 h post-dose; and week 21, day 1, pre-dose (0 hour (h)) and 2 h post-dose|The Pharmacokinetic analysis set for all participants was considered for this analysis, but only participants with non-missing values were included in the analysis.||umol/L||Standard Deviation|Mean
647384|NCT02125877|Secondary|Time to Reach the Maximum Plasma Concentration After Drug Administration (Tmax)|Blood samples were collected to assess Tmax.|week 1, day 1: pre-dose (0 hour) and 1, 2, 3, 4, 8 and 24 hours post dose; week 3, day 1: pre-dose (0 hour) and 1, 2, 3, 4, 8 and 24 hours post dose|The Pharmacokinetic subset A analysis set was considered for the analysis, but only participants with non-missing values were analyzed||hour||Full Range|Median
647385|NCT02125877|Secondary|Observed Maximum Plasma Concentration Following Drug Administration (Cmax)|Blood samples were collected to assess Cmax.|week 1, day 1: pre-dose (0 hour) and 1, 2, 3, 4, 8 and 24 hours post dose; week 3, day 1: pre-dose (0 hour) and 1, 2, 3, 4, 8 and 24 hours post dose|The Pharmacokinetic subset A analysis set was considered for the analysis, but only participants with non-missing values were analyzed||umol/L||Standard Deviation|Mean
647386|NCT02125877|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)|Blood samples were collected to assess AUClast.|week 1, day 1: pre-dose (0 hour) and 1, 2, 3, 4, 8 and 24 hours post dose; week 3, day 1: pre-dose (0 hour) and 1, 2, 3, 4, 8 and 24 hours post dose|The Pharmacokinetic subset A analysis set was considered for the analysis, but only participants with non-missing values were analyzed.||umol/L*h||Standard Deviation|Mean
647387|NCT02125877|Secondary|Weekly Dose Violation Rate|The dose violation is defined as a dose either missed completely or not taken in accordance with the timing instruction (no later than 12:00 pm. The rate was calculated as [number of dose violations/drug exposure (days)] x 100.|weeks 1, 4, 8, 12, 16, 20, 24|The safety set, which included all participants who received at least one dose of study drug, was considered for the analysis. However, only participants with values at the given week were included in the analysis for that week.||percent dose violation||Standard Deviation|Mean
647388|NCT02125877|Secondary|Number of Participants With Weekly Average Compliance of Medication Consumption|A compliance questionnaire assessed whether the medication was taken. Weekly average compliance was calculated when there were at least four non-missing daily responses.|Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24|The safety set, which included all participants who received at least one dose of study drug, was analyzed.||Participants|||Number
647389|NCT02125877|Secondary|Weekly Average of Daily Scores of the Gastrointestinal (GI) Symptom Diary|The GI symptom diary consisted of 6 items, five which were scored using a 0 - 10 rating scale with item appropriate anchors to rate the symptom, for example, Pain in your belly: 0 = no pain and 10 = worst pain. The GI diary summary score was created using the 10 point response scale for the 5 items. The GI symptom daily diary had a minimum score of 0 and a maximum score of 50. The weekly average score for the 7 days was calculated for each individual item and the GI summary score was created from these weekly averages. Higher scores indicated worse symptoms. A meaningful difference between two treatment arms was determined to be 0.3 point.|weeks -1, 4, 8, 12, 16, 20, 24|The safety set, which included all participants who received at least one dose of study drug, was considered for the analysis. However, only participants with values at the given week were included in the analysis for that week.||score on a scale||Standard Deviation|Mean
647390|NCT02125877|Secondary|Palatability Questionnaire Score|"The palatability questionnaire consisted of 4 items. The first item measured the taste and aftertaste of the medication and were scored a on a 5-point response scale. The second item offered an additional response option of no aftertaste. The last 2 items referred to whether the medication was taken, i.e. swallowed or vomited, and how the participant perceived the amount of medication to be taken. The palatability summary score was calculated using a scoring matrix from items 1, 3 and 4 scores and the score ranges from 0 - 11. Higher scores indicated the best palatability. A meaningful difference between two treatment arms was determined to be 1 point."|weeks 2, 3, 13 and 24 (end of treatment or within 7 days of last dose)|The safety set, which included all participants who received at least one dose of study drug, was considered for the analysis. However, only participants with values at the given week were included in the analysis for that week.||score on a scale||Standard Deviation|Mean
647391|NCT02125877|Secondary|Mean Domain Scores of the Modified Satisfaction With Iron Chelation Therapy (Modified SICT)|The modified SICT consisted of 13 items that represent 3 domains: adherence, satisfaction and concerns. The adherence domain consisted of 7 items, 6 which were measured using a 5-point response scale and was calculated by summing the 6 items. The score range from 6 to 30 and higher scores indicated worse adherence. The satisfaction domain consisted of 3 items, 2 which were measured using a 5-point response scale and was calculated by summing the 2 items. The score range from 2 to 10 and higher scores indicated worse satisfaction. The concerns domain consisted of 3 items to address any concerns or worries with his/her medication. All 3 items were measured on a 5-point response scale and were calculated by summing the 3 items. The score range from 3 to 15 and higher scores indicated fewer concerns. For all three domains, the meaningful difference between two treatment arms was determined to be 1 point.|weeks 2, 3, 13 and 24 (end of treatment or within 7 days of last dose)|The safety set, which included all participants who received at least one dose of study drug, was considered for the analysis. However, only participants with values at the given week were included in the analysis for that week.||score on a scale||Standard Deviation|Mean
647394|NCT02125877|Primary|Overall Safety as Measured by Frequency of Adverse Events|The percentage of participants with adverse events, serious adverse events and deaths was assessed.|28 weeks|The safety set, which included all participants who received at least one dose of study drug, was analyzed.||Percentage of participants|||Number
647395|NCT02125838|Primary|Asses to Mean Pressure|mean pressures within the times below (cmH20) T1= 2 minutes after airway device insertion T2= 10 minutes after insufflation T3= Before desufflation T4= Before removal of airway device|during procedure|||cmH20||Standard Deviation|Mean
647396|NCT02125838|Primary|Asses to Peak Pressure|peak pressure (cmH20) at certain time intervals T1= 2 minutes after airway device insertion T2= 10 minutes after insufflation T3= Before desufflation T4= Before removal of airway device|intraoperative period|||cmH20||Standard Deviation|Mean
647397|NCT02125838|Secondary|Incidence of Post-operative Sore Throat|Patients were asked about the presence of sore throat - defined as the presence of constant pain in the throat, independent of swallowing, 1 hr and 24 hr after the end of surgery.|Baseline||||||
647398|NCT02125838|Secondary|Haemodynamic Response to Insertion of Airway Device|Systolic blood pressure and heart rate at two minutes after LM-S placement, before insufflation, 10 minutes after insufflation and trendelenburg position, before desufflation and before LM-S removal .|Baseline||||||
647399|NCT02125838|Secondary|Ease of Orogastric Tube Placement Classification|Ease of placement was classified by the person who inserted the orogastric tube as very easy, easy, difficult or very difficult.|Baseline|Ease of placement was classified by the person who inserted the orogastric tube as very easy, easy, difficult or very difficult.||participants|||Number
647400|NCT02125838|Secondary|Evaluation of Gastric Distention|To provide the adequate gastric distention of either the LM-Supreme or the tracheal tube, as assigned. Gastric distension was evaluated by a surgeon blind to the airway device used between 0-10 (0=empty stomach, 10=distension obstructing the surgical field)|Baseline|||units on a scale||Standard Deviation|Mean
647401|NCT02125838|Secondary|Quality of View According to Surgeon by Rate Scale|"Quality of surgical view will be assessed with points from 1 to 4 by the surgeon blind to the airway device by Rate Scale.
Grade of quality of view were evaluated between 1-4 points (1-poor to 4-excellent)"|intraoperative period|||percentage of participants|||Number
647402|NCT02125838|Primary|Asses to Ventilation Parameters|tidal volume (ml) at certain time intervals T1= 2 minutes after airway device insertion T2= 10 minutes after insufflation T3= Before desufflation T4= Before removal of airway device|intraoperative period|||ml||Standard Deviation|Mean
647403|NCT02125734|Secondary|Investigator Preference Per Patient After Experiencing Both Treatments for Future Suggestions.|The investigator preference for future treatment suggestion after experiencing both treatments was assessed at the end of treatment period 2 with the Investigator Preference Questionnaire|8 weeks|Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period. One patient with missing data for this analysis.||Participants|||Number
647404|NCT02125734|Secondary|Patient Preference After Experiencing Both Treatments Was Assessed at the End of Treatment Period 2 With a Patient Preference Questionnaire.|Patient preference after experiencing both treatments. The patient’s preference questionnaire was a two-choice question (preference for QVA149 OR Tiotropium.|8 weeks|Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period. Three patients were missing data for the patient preference analysis.||Participants|||Number
647405|NCT02125734|Primary|Forced Expiratory Volume in One Second (FEV1) at 1 h Post-inhalation|Forced Expiratory Volume in one second (FEV1) will be calculated as the volume of air forcibly exhaled in one second as measured by a spirometer.|week 4|Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period||Liters||95% Confidence Interval|Least Squares Mean
647406|NCT02125604|Primary|Duration of Gastrointestinal-Related Events in Participants Who Utilize Symptomatic Therapy During the 12-Week Treatment Period, MAGISS|Percentage of days with GI events as reported on MAGISS was calculated for each participant and each analysis period using the following formula: 100 x (# of days with [GI] events / # of days tolerability scale completed). The ST categories were provided by Biogen Medical team as follows: ST1=anti-acid production; ST2=anti-bloating/anti-constipation agent; ST3=multitarget/ herbal agents; ST4=anti-diarrheal (anti-peristaltic); ST5=analgesic (NSAID); ST6=anti-emetic (central); ST7=anti-emetic (pro-kinetic); ST8=antacid; ST9=other; ST10=laxative (pro-kinetic). Overall GI events were reported in the second day after the dose. Relative day for Overall GI events = assessment date-first dose date.|Up to Week 12|Safety Population: all participants who received at least 1 dose of dimethyl fumarate and used symptomatic therapy; n=participants with an evaluable assessment during given time period.||percentage of days||Standard Deviation|Mean
647407|NCT02125604|Secondary|Percentage of Participants Who Discontinued Dimethyl Fumarate Due To Gastrointestinal-Related Treatment-Emergent Adverse Events||Up to Week 12|Safety Population: all participants who received at least 1 dose of dimethyl fumarate.||percentage of participants|||Number
647408|NCT02125604|Secondary|Percentage of Participants Who Required Dimethyl Fumarate Dose Reduction In Response To Gastrointestinal-Related Events|Dose reductions are defined as participants who take any dimethyl fumarate 120 mg or 0 mg since initiation of dimethyl fumarate 240 mg.|Up to Week 12|Safety Population: all participants who received at least 1 dose of dimethyl fumarate.||percentage of participants|||Number
647409|NCT02125604|Secondary|Duration of Use of Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category|Symptomatic therapies were classified into 10 categories: anti-acid production (eg, pantoprazole, omeprazole, esomeprazole, ranitidine); anti-bloating/anti-constipation agents (eg, hyoscine butylbromide, sodium picosulfate, Agiolax, dimeticone, lactulose, Movicol, simethicone); multitarget/herbal agents (eg, Iberogast, Gaviscon, amaratropfen, Wikalin, Gaviscon & Iberogast, Iberogast & Wikalin); anti-diarrheal (anti-peristaltic; loperamide, racecadotril); analgesic (NSAID; ibuprofen, paracetamol, metamizole); anti-emetic (central; dimenhydrinate, domperidone); anti-emetic (pro-kinetic; metoclopramide); anti-acid (calcium carbonate, magaldrate, sodium hydrogen carbonate, sodium hydroxide/aluminium oxide, Talcid); other (Saccharomyces boulardii, carbon tablet, Lactobacillus acidophilus); laxative (pro-kinetic; bisacodyl). If a participant had multiple different therapies on the same day, the days on symptomatic therapy was calculated as 1 day in 'All therapies'.|Up to Week 12|Safety Population: all participants who received at least 1 dose of dimethyl fumarate and used symptomatic therapy; n=participants with an evaluable assessment during given time period.||days||Standard Deviation|Mean
647410|NCT02125604|Secondary|Number of Participants Who Used Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category|Symptomatic therapies were classified into 10 main categories: anti-acid production (eg, pantoprazole, omeprazole, esomeprazole, ranitidine); anti-bloating/anti-constipation agents (eg, hyoscine butylbromide, sodium picosulfate, Agiolax, dimeticone, lactulose, Movicol, simethicone); multitarget/herbal agents (includes Iberogast, Gaviscon, amaratropfen, Wikalin, Gaviscon & Iberogast, Iberogast & Wikalin); anti-diarrheal (anti-peristaltic; loperamide, racecadotril); analgesic (non-steroidal anti-inflammatory drug [NSAID]; ibuprofen, paracetamol, metamizole); anti-emetic (central; dimenhydrinate, domperidone); anti-emetic (pro-kinetic; metoclopramide); anti-acid (calcium carbonate, magaldrate, sodium hydrogen carbonate, sodium hydroxide/aluminium oxide, Talcid); other (Saccharomyces boulardii, carbon tablet, Lactobacillus acidophilus); laxative (pro-kinetic; bisacodyl). Participants may have taken > 1 symptomatic therapy but were counted only once for the 'All therapies' summary.|Up to Week 12|Safety Population: all participants who received at least 1 dose of dimethyl fumarate and used symptomatic therapy.||participants|||Number
647411|NCT02125604|Secondary|Percentage of Participants Who First Took Symptomatic Therapy for Gastrointestinal-Related Events at Weeks 4, 8, and 12|The cumulative percentage of dimethyl fumarate-treated participants with relapsing-remitting multiple sclerosis who required symptomatic therapy up to Week 4, Week 8, and Week 12 were estimated using the Kaplan-Meier method.|Week 4, Week 8, Week 12|Safety Population: all participants who received at least 1 dose of dimethyl fumarate and used symptomatic therapy.||percentage of participants|||Number
647412|NCT02125604|Primary|Duration of Gastrointestinal-Related Events in Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MOGISS|The percentage of days with GI events as reported on MOGISS was calculated for each participant and each analysis period using the following formula: 100 x (# of days with [GI] events / # of days tolerability scale completed). The symptomatic therapy (ST) categories were provided by Biogen Medical team as follows: ST1=anti-acid production; ST2=anti-bloating/anti-constipation agent; ST3=multitarget/ herbal agents; ST4=anti-diarrheal (anti-peristaltic); ST5=analgesic (NSAID); ST6=anti-emetic (central); ST7=anti-emetic (pro-kinetic); ST8=antacid; ST9=other; ST10=laxative (pro-kinetic). Overall GI events were reported in the second day after the dose. Relative day for Overall GI events = assessment date-first dose date.|Up to Week 12|Safety Population: all participants who received at least 1 dose of dimethyl fumarate and used symptomatic therapy; n=participants with an evaluable assessment during given time period.||percentage of days||Standard Deviation|Mean
647413|NCT02125604|Primary|Worst Severity Of Gastrointestinal-Related Events In Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MAGISS|The MAGISS is a questionnaire about the overall events related to the gastrointestinal system (including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, and flatulence) following drug administration (acute symptoms). MAGISS is based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms. The worst overall severity score for gastrointestinal-related events was calculated for each participant for the overall treatment period of 12 weeks, and for each 4-week period therein.|Up to Week 12|Safety Population: all participants who received at least 1 dose of dimethyl fumarate and used symptomatic therapy; n=participants with an evaluable assessment during given time period.||units on a scale||Standard Deviation|Mean
647414|NCT02125604|Primary|Worst Severity Of Gastrointestinal-Related Events In Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MOGISS|The MOGISS is a questionnaire about overall events related to the gastrointestinal system (including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, and flatulence) during the 24 hours prior to each AM dose. MOGISS is based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms. The worst overall severity score for gastrointestinal-related events was calculated for each participant for the overall treatment period of 12 weeks, and for each 4-week period therein.|Up to Week 12|Safety Population: all participants who received at least 1 dose of dimethyl fumarate and used symptomatic therapy; n=participants with an evaluable assessment during given time period.||units on a scale||Standard Deviation|Mean
647415|NCT02125604|Primary|Number of Participants Who Utilized Symptomatic Therapy With Gastrointestinal-Related Events During the 12-Week Treatment Period: Modified Acute Gastrointestinal Symptom Scale (MAGISS)|The MAGISS is a questionnaire in which participants reported overall acute gastrointestinal-related events, (especially symptoms of nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, and flatulence) for each 10 hours after the AM and PM doses of study drug. Participants who rated the intensity of gastrointestinal-related events reported on MAGISS, included the duration of the gastrointestinal-related events and each symptomatic therapy used in the eDiary are presented.|Up to Week 12|Safety Population: all participants who received at least 1 dose of dimethyl fumarate; n=participants with an assessment during given time period.||Participants|||Number
647416|NCT02125604|Primary|Number of Participants Who Utilized Symptomatic Therapy With Gastrointestinal-Related Events During the 12-Week Treatment Period: Modified Overall Gastrointestinal Symptom Scale (MOGISS)|The MOGISS is a questionnaire about the severity of overall gastrointestinal-related events, including specifically symptoms of nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, and flatulence for 24 hours before the AM dose. Participants who rated the intensity of symptoms reported on the MOGISS and included each symptomatic therapy used in the eDiary are presented.|Up to Week 12|Safety Population: all participants who received at least 1 dose of dimethyl fumarate; n=participants with an assessment during given time period.||Participants|||Number
647417|NCT02125292|Secondary|Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Results|Subjects underwent a standard 12-lead ECG 6 hours post-dose. The investigator assessed if the ECG tracing was normal or abnormal; if abnormal, the investigator made a determination of whether or not the abnormality was clinically significant.|1 day|Safety Set: all participants who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||participants|||Number
647445|NCT02124304|Secondary|Perceived Exertion|Thera-Band(R) RISE (Resistance Intensity Scale for Exercise) Scale to measure amount of perceived exertion during resistance band exercises. Participants were asked to rate the intensity of an exercise on a scale from 0 to 10, 0 being no resistance and 10 being the maximum resistance.|12 exercises during one 1 hour session|||units on a scale, ranging from 0 to 10||Full Range|Mean
647418|NCT02125292|Secondary|Number of Participants With Potentially Clinically Important Vital Signs|Vital sign assessments included systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate and body temperature measurements, all measured 6 hours post-dose. Study personnel used both absolute values and change from baseline values to determine if the vital sign was potentially clinically important. Criteria for the potential clinical importance of both absolute and change from baseline values were pre-specified. A participant's vital sign had to meet both the absolute and change from baseline criteria to be considered as potentially clinically important.|1 day|Safety Set: all participants who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||participants|||Number
647419|NCT02125292|Secondary|Number of Participants With Potentially Clinically Important Laboratory Results|Clinical laboratory assessments included hematology, chemistry and urinalysis parameters, all measured 6 hours post-dose. All clinical laboratory assays were performed according to the laboratory’s normal procedures. Reference ranges were supplied by the laboratory and were used to assess the clinical laboratory data for clinical significance and out-of-range pathological changes. The investigator assessed out-of-range clinical laboratory values for clinical significance and indicated whether or not the values were clinically significant.|1 day|Safety Set: all participants who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||participants|||Number
647420|NCT02125292|Secondary|Number of Participants Who Experienced an Adverse Event|Participants were monitored for treatment-emergent adverse events through the follow-up assessment, which occurred 2 days +/- 1 day post-dose.|4 days|Safety Set: all participants who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||participants|||Number
647421|NCT02125292|Primary|Number of Participants Willing to Take Mesalamine Via Treatment Method on a Regular Basis|"The participants were asked to answer Yes or No to the following question: Would you be willing to take medicine this way on a regular basis if necessary? The number of participants who answered Yes is reported."|Immediately post-dose|Pharmacodynamic Set: all participants who took at least 1 dose of investigational product and had at least 1 post-dose taste assessment.||participants|||Number
647422|NCT02125292|Primary|Number of Participants With Positive Responses to Palatability Assessment of The Aftertaste of Mesalamine|"An aftertaste assessment was completed 5 minutes after administration of investigational product to assess the subject's rating of aftertaste and means of administration. The assessment consisted of a 5-point rating scale. The participants were asked to choose one of the following responses to the statement The aftertaste (if present) was acceptable: strongly agree, agree, neutral, disagree, or strongly disagree. The number of participants who chose either of the top two responses (strongly agree, agree) is reported."|5 minutes post-dose|Pharmacodynamic Set: all participants who took at least 1 dose of investigational product and had at least 1 post-dose taste assessment.||participants|||Number
647423|NCT02125292|Primary|Number of Participants Who Detected an Aftertaste of Mesalamine|"An aftertaste assessment was completed 5 minutes after administration of investigational product to assess whether the participants detected an aftertaste. The participants answered Yes or No to the following question: Was there an aftertaste? The number of participants who answered Yes is reported."|5 minutes post-dose|Pharmacodynamic Set: all participants who took at least 1 dose of investigational product and had at least 1 post-dose taste assessment.||participants|||Number
647424|NCT02125292|Primary|Number of Participants With Positive Responses to Palatability Assessment of The Taste of Mesalamine|"A taste assessment was completed immediately after investigational product was administered to assess the subject’s taste/liking of the formulation. The assessment consisted of a 5-point rating scale. Participants were asked to choose one of the following responses to the statement The taste was acceptable: strongly agree, agree, neutral, disagree, or strongly disagree. The number of participants who chose either of the top two responses (strongly agree, agree) is reported."|Immediately post-dose|Pharmacodynamic Set: all participants who took at least 1 dose of investigational product and had at least 1 post-dose taste assessment.||participants|||Number
647425|NCT02124863|Primary|Number of Refluxes|Every two hours after feeding, the number of refluxes during 20 minutes are measured. The mean number of refluxes during these periods were calculated and compared to the number of refluxes during 20 minutes of IPV|during 20 minutes of IPV compared to mean number of refluxes during 20 minutes.|All patients receiving IPV were their own controls||number of refluxes||Standard Deviation|Mean
647426|NCT02124798|Secondary|Number of Participants Who Reported They Were Successfully Able to Self-administer Their Doses Outside the Clinic Setting in Weeks 3, 5, 6, and 7 (Outside Clinic)|Assessment was performed for suitability of the auto injector for self-administration of belimumab by participant with SLE outside the clinic setting. An overall assessment of usability and reliability for the device was determined by assessing the rate of successfully complete self-administered injections relative to attempted ones. The assessment for the parameter, drug successfully injected was elicited by a Yes/No response. The participants who were able to administer injections outside of the clinic without assistance were included.|Weeks 3, 5, 6, and 7 (Outside clinic)|ITT population. Only those participants with data available at the indicated time points were analyzed.||Participants|||Number
647427|NCT02124798|Secondary|Number of Participants Successfully Able to Self-administer Their Observed Doses in Weeks 4 and 8 (Inside Clinic)|The main objective was to assess the suitability of the auto injector for self-administration of belimumab by participants with SLE. An overall assessment of usability and reliability for the device was determined by assessing the rate of successfully complete self-administered injections relative to attempted ones. The assessment for the parameter, drug successfully injected was elicited by a Yes/No response. The participants who were able to administer injections inside and outside of the clinic without assistance were included.|Weeks 4 and 8 (Inside clinic)|ITT population. Only those participants with data available at the indicated time points were analyzed.||Participants|||Number
647460|NCT02124044|Primary|The Percentage of Subjects Who Achieve Sustained Viral Response (SVR12) 12 Weeks After the Stop of Treatment Drugs|The primary outcome was the percentage of patients with sustained viral response measured 12 weeks after the stop of treatment. The viral response was assessed by serum HCV RNA concentrations lower than 43 IU/mL - the lower limit of quantification.|12 weeks after stop of treatment|Subjects who received treatment drugs per arm as listed in the Outcome Measure Description||Percentage of subjects|||Number
651411|NCT02029521|Secondary|FEV1|Forced expiratory volume at one second, percent predicted|3 months|Pulmonary function tests not performed on children under the age of 5||Percent predicted||Standard Deviation|Mean
647428|NCT02124798|Primary|Number of Participants Successfully Able to Self-administer Their Observed First and Second Doses in Weeks 1 and 2 (Inside Clinic)|The primary objective was to assess the suitability of the auto injector for self-administration of belimumab. An overall assessment of usability and reliability for the device was determined by assessing the rate of successfully complete self-administered injections relative to attempted ones. The assessment for the parameter, drug successfully injected was elicited by a Yes/No response. The participants who were able to administer injections inside and outside of the clinic without assistance were included.|Weeks 1 and 2 (Inside clinic)|The intention-to-treat (ITT) population was defined as all participants who were enrolled and treated with at least 1 dose of belimumab. Only those participants with data available at the indicated time points were analyzed.||Participants|||Number
647429|NCT02124603|Secondary|Eradication Rate|Number of participants having positive culture at the screening visit with bacterial eradication before surgery|Day of surgery|Number of participants with positive culture at the screening visit||partecipants|||Number
647430|NCT02124603|Secondary|Antibiotic Susceptibility|Isolated bacteria were tested for their in vitro susceptibility to commercially available ophthalmic antibiotics by the disk diffusion test and categorized as susceptible, intermediate or resistant.|At least 14 days before surgery|Percentage of isolates susceptibility to antibiotics||percentage of susceptible isolates|Participants||Number
647431|NCT02124603|Primary|Positive Culture in Subjects Scheduled for Cataract Surgery|Number of participants with positive culture at the screening visit|At least 14 days before surgery|Number of participants with positive culture||subjects|||Number
647432|NCT02124460|Post-Hoc|Parent Very Satisfied With Information he/She Received About Resources in the Community|This is a feasibility and acceptability measure from the study.|1 year|The number of participant analyzed was based only on those who completed the follow-up survey (as the questions were not asked at baseline) and excluded those with missing responses. Additionally, only those who responded Yes to the previous question asking if they received community resources were included in this analysis.||Participants|||Count of Participants
647433|NCT02124460|Post-Hoc|Received Text Messages or Emails From Connect 4 Health|This is a feasibility and acceptability measure from the study.|1 year|The number of participant analyzed was based only on those who completed the follow-up survey (as the questions were not asked at baseline) and excluded those with missing responses.||Participants|||Count of Participants
647434|NCT02124460|Post-Hoc|Received Information From Connect 4 Health About Resources in the Community|This is a feasibility and acceptability measure from the study.|1 year|The number of participant analyzed was based only on those who completed the follow-up survey (as the questions were not asked at baseline) and excluded those with missing responses.||Participants|||Count of Participants
647435|NCT02124460|Post-Hoc|Parent Very Satisfied With Content of Connect 4 Health Text Messages or Emails.|This is a feasibility and acceptability measure from the study.|1 year|The number of participant analyzed was based only on those who completed the follow-up survey (as the questions were not asked at baseline) and excluded those with missing responses. Additionally, only those who responded Yes to the previous question asking if they received text messages were included in this analysis.||Participants|||Count of Participants
647436|NCT02124460|Post-Hoc|Increased Satisfaction With Care at Harvard Vanguard Medical Associates (HVMA)|This is a feasibility and acceptability measure from the study.|1 year|The number of participant analyzed was based only on those who completed the follow-up survey (as the questions were not asked at baseline) and excluded those with missing responses.||Participants|||Count of Participants
647437|NCT02124460|Secondary|Change in Consumption of Sugar-sweetened Beverages and Juice|Number of time child consumed juice (e.g., orange juice, apple juice, or grape juice), fruit-flavored drinks (e.g., Kool-Aid, sports drinks, Goya juice, etc.), regular soda, soft drinks, or Malta yesterday.|baseline and 1 year|||times/day||95% Confidence Interval|Mean
647438|NCT02124460|Secondary|Change in Fruit and Vegetable Consumption|Number of times the child consumed of vegetables and fruits yesterday|baseline and 1 year|||times/day||95% Confidence Interval|Mean
647439|NCT02124460|Secondary|Change in Physical Activity|In the past week, how many days the child was physically active for a total of at least 60 minutes per day.|baseline and 1 year|||days/week||95% Confidence Interval|Mean
647440|NCT02124460|Secondary|Change in Sleep|Average hours/day spent sleeping|baseline and 1 year|||hours/day||95% Confidence Interval|Mean
647441|NCT02124460|Secondary|Change in Screen Time|Average hours/day spent watching television, videos, or playing games displayed on media such as television, desktop computers, laptops, portable DVD players, iPads or smartphones.|baseline and one year|||hours/day||95% Confidence Interval|Mean
647442|NCT02124460|Primary|Change in Parent Resource Empowerment|The five items in the scale assessed parents’ perceived knowledge of resources, ability to access resources, comfort with accessing resources, knowledge of how to find resources, and ability to acquire resources related to child weight management. For each question, parents responded strongly disagree, disagree, agree, or strongly agree, which were worth 1 to 4 points, respectively. Items were averaged to create a summary parental resource empowerment score (range= 1-4), where a higher score indicated greater perceived knowledge and ability to access resources related to weight management. Cronbach’s α for this score was 0.87.|Baseline to one-year follow-up|||units on a scale||95% Confidence Interval|Mean
647443|NCT02124460|Primary|Change in Quality of Life|The PedsQL is an extensively validated, widely used, 23-item measure of health-related quality of life in children with chronic conditions such as obesity. Parents will be asked to complete 4 subscales: physical health, school, social, and emotional functioning which exists for parental report of children as young as 2 years of age. Items are reverse-scored and linearly transformed to a 0–100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0), so that higher scores indicate better HRQOL. Scale Scores are computed as the sum of the items divided by the number of items answered (this accounts for missing data). If more than 50% of the items in the scale are missing, the Scale Score is not computed.|baseline and one year|||units on a scale||95% Confidence Interval|Mean
647444|NCT02124460|Primary|Change in BMI z Score|Height and weight will be measured by the medical assistants at each site using standard protocols. BMI measures will be obtained from the electronic health record (EHR) as provided through usual care. BMI measures will be converted to z-scores using CDC age and sex-specific normative data for children between 2 and 20 years old. This will allow the research team to combine data across children of different ages.|baseline and one year|||BMI z score units||95% Confidence Interval|Mean
647446|NCT02124304|Primary|Percent of Peak Activation (%PA)|8 muscles during 12 exercises were analyzed in 30 subjects, totaling 2880 data points. At the beginning of the study, peak activation (PA) was assessed for each muscle during full flexion-extension, used as a reference exercise. For each subject, the EMG signals of the muscles during the 12 exercises were smoothed, rectified and analyzed using a root-mean-square algorithm and the greatest activation of each muscle was used. After the PA for each muscle was determined, it was compared to the PA of the reference exercise for the respective muscle group, and expressed as a percent of the peak activation (%PA). In some cases the %PA is greater than 100%. This is possible as the PA was assessed during a full flexion-extension movement. During an exercise some muscles generated greater PA and therefore when the calculations were performed the %PA was greater than 100%. Due to the extensive amount of data, we have provided the Left Cervical Paraspinals %PA results for each exercise.|One 1 hour session|||Percentage of Peak Activation (%PA)||Full Range|Mean
647447|NCT02124161|Secondary|Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition Assay (HAI) 1 Month After Vaccination 1 to Immediately Before Vaccination 1|"Fold rise 1 month after Vaccination 1 to before Vaccination 1 was calculated for each influenza virus strain (A/H1N1, A/H3N2, B/Brisbane and B/Massachusetts). GMFRs were calculated using all participants with available data from both the specified blood draws. CI for the GMFRs were back transformations of a CI based on the Student t distribution for mean fold rise. Here, number of participants analyzed signifies participants with valid and determinate assay results for specified strain at both the specified blood draws."|Immediately before Vaccination 1, 1 month after Vaccination 1|Evaluable immunogenicity population: eligible, randomized participants of 50 years of age or above, received all study vaccinations in assigned sequence with expected concomitant vaccination, had at least 1 valid, determinate assay results, had pre and post vaccination blood drawn within protocol-specified time frames, no major protocol violations.||fold rise||95% Confidence Interval|Geometric Mean
647448|NCT02124161|Secondary|Percentage of Participants Achieving Seroconversion in Hemagglutination Inhibition Assay (HAI) Titers|"Percentage of participants achieving seroconversion in HAI titers was defined as the percentage of participants with either before Vaccination 1 (pre-vaccination 1) HAI titer less than <1:10 and after Vaccination 1 (post-vaccination 1) HAI titer >=1:40 or before Vaccination 1 (pre-vaccination 1) HAI titer >=1:10 and a minimum 4-fold rise in after Vaccination 1 (post-vaccination 1) HAI antibody titer with respect to before Vaccination 1 (pre-vaccination) titer for influenza virus strains. Here, number of participants analyzed signifies the participants who were evaluable at this timepoint."|Immediately before Vaccination 1, 1 month after Vaccination 1|Evaluable immunogenicity population: eligible, randomized participants of 50 years of age or above, received all study vaccinations in assigned sequence with expected concomitant vaccination, had at least 1 valid, determinate assay results, had pre and post vaccination blood drawn within protocol-specified time frames, no major protocol violations.||percentage of participants||95% Confidence Interval|Number
647449|NCT02124161|Secondary|Geometric Mean Fold Rise (GMFR) for Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers 1 Month After 13vPnC Vaccination 2 to Immediately Before 13vPnC Vaccination 2|"GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) 1 month after Vaccination 2 to before Vaccination 2 (1 month after Vaccination 1) were computed using the logarithmically transformed assay results. CIs for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both before Vaccination 2 and 1 month after Vaccination 2 blood draws. Here, number of participants analyzed signifies total participants who were evaluable at this timepoint and n signifies participants with valid and determinate assay results for specified serotype at both the given visits. Number of participants who received at least 1 dose of 13vPnC during Vaccination 2 were analyzed."|Immediately before Vaccination 2, 1 month after Vaccination 2|Evaluable immunogenicity population: eligible, randomized participants of 50 years of age or above, received all study vaccinations in assigned sequence with expected concomitant vaccination, had at least 1 valid, determinate assay results, had pre and post vaccination blood drawn within protocol-specified time frames, no major protocol violations.||fold rise||95% Confidence Interval|Geometric Mean
647450|NCT02124161|Secondary|Geometric Mean Fold Rise (GMFR) for Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers 1 Month After 13vPnC Vaccination 1 to Immediately Before 13vPnC Vaccination 1|"GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) 1 month after Vaccination 1 to before Vaccination 1 were computed using the logarithmically transformed assay results. CIs for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both before Vaccination 1 and 1 month after Vaccination 1 blood draws. Here, n signifies participants with valid and determinate assay results for specified serotype at both the given visits. Number of participants who received at least 1 dose of 13vPnC during Vaccination 1 were analyzed."|Immediately before Vaccination 1, 1 month after Vaccination 1|Evaluable immunogenicity population: eligible, randomized participants of 50 years of age or above, received all study vaccinations in assigned sequence with expected concomitant vaccination, had at least 1 valid, determinate assay results, had pre and post vaccination blood drawn within protocol-specified time frames, no major protocol violations.||fold rise||95% Confidence Interval|Geometric Mean
647461|NCT02123745|Secondary|Significant Skin Irritation or Disruption to Skin Integrity|The number of IV sites that indicated significant skin irritation or disruption to skin integrity assessed at the end of the study.|After each participant has been infiltrated, an expected average of 1 hour|||participants|||Number
647462|NCT02123745|Secondary|Infiltrated Volume When Yellow Notification Issued|The amount of infiltrated isotonic saline solution when the yellow notification was issued by the ivWatch Model 400 device.|After each participant has been infiltrated, an expected average of 1 hour|||mL|Participants|Standard Deviation|Mean
647463|NCT02123745|Secondary|Infiltrated Volume When Red Notification Issued|The amount of infiltrated isotonic saline solution when the red notification was issued by the ivWatch Model 400 device.|After each participant has been infiltrated, an expected average of 1 hour|||mL|Participants|Standard Deviation|Mean
647464|NCT02123745|Secondary|Yellow Notification Sensitivity to Infiltrated Tissues|The ratio of the number of infiltrated IV sites where the ivWatch Model 400 device issued a yellow notification to the total number of infiltrated IV sites in the study. All infiltrations were limited to 10 mL of isotonic saline solution.|After each participant has been infiltrated, an expected average of 1 hour|||percentage of infiltrations|Participants|95% Confidence Interval|Number
647451|NCT02124161|Secondary|Percentage of Participants Achieving Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibody Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)|"Percentage of participants achieving predefined OPA antibody titer >= LLOQ for each of the 13 pneumococcal serotypes (LLOQs for each serotype OPA were set as- serotype 1: 18; serotype 3: 12; serotype 4: 21; serotype 5: 29; serotype 6A: 37; serotype 6B: 43; serotype 7F: 210; serotype 9V: 345; serotype 14: 35; serotype 18C: 31; serotype 19A: 18; serotype 19F: 48; and serotype 23F: 13) determined in blood samples of all participants were calculated. Exact, 2-sided 95% CIs based on the observed percentage of participants were determined by using Clopper and Pearson method. OPA titers were calculated using all participants with available data from 1 month after 13vPnC vaccination blood draw. Here, number of participants analyzed signifies the participants who were evaluable at this timepoint and n signifies participants with valid and determinate assay results to the specified serotype."|1 Month After Vaccination 1 for 13vPnC+QIV/Placebo, 1 month after Vaccination 2 for Placebo+QIV/13vPnC|Evaluable immunogenicity population: eligible, randomized participants of 50 years of age or above, received all study vaccinations in assigned sequence with expected concomitant vaccination, had at least 1 valid, determinate assay results, had pre and post vaccination blood drawn within protocol-specified time frames, no major protocol violations.||percentage of participants||95% Confidence Interval|Number
647452|NCT02124161|Primary|Percentage of Participants With Treatment-­Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) at the 6-Month Follow-up|An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious adverse events (Non-SAEs).|Within 168 to 196 days after Vaccination 2|Safety population included all participants who received at least 1 dose of vaccination.||percentage of participants|||Number
647453|NCT02124161|Primary|Percentage of Participants With Treatment-­Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) After 13vPnC Vaccination|An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious adverse events (Non-SAEs).|Baseline (Vaccination 1) up to 28 to 42 Days after Vaccination 2|"Safety population included all participants who received at least 1 dose of vaccination. Here, number of participants analyzed signifies participants who were evaluable at this timepoint."||percentage of participants|||Number
647454|NCT02124161|Primary|Percentage of Participants With Treatment-­Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) After Vaccination 2|An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious adverse events (Non-SAEs).|Within 28 to 42 days after Vaccination 2|"Safety population included all participants who received at least 1 dose of vaccination. Here, number of participants analyzed signifies participants who were evaluable at this timepoint."||percentage of participants|||Number
647455|NCT02124161|Primary|Percentage of Participants With Treatment-­Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) After Vaccination 1|An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious adverse events (Non-SAEs).|Within 28 to 42 days after Vaccination 1|Safety population included all participants who received at least 1 dose of vaccination.||percentage of participants|||Number
647456|NCT02124161|Primary|Hemagglutination Inhibition Assay (HAI) Geometric Mean Titers (GMTs) for Each Influenza Virus Strain in Quadrivalent Influenza Vaccine (QIV)|"HAI GMTs were computed for assay titers collected 1 month after Vaccination 1 by vaccine sequence for each influenza virus strain (A/H1N1, A/H3N2, B/Brisbane and B/Massachusetts). CIs were back-transformations of a CI based on the Student t distribution for the mean logarithm of the titers. HAI GMTs were calculated using all participants with available data for the specified blood draw. Here, number of participants analyzed signifies participants with a determinate HAI titer to the given strain."|1 month after Vaccination 1|Evaluable immunogenicity population: eligible, randomized participants of 50 years of age or above, received all study vaccinations in assigned sequence with expected concomitant vaccination, had at least 1 valid, determinate assay results, had pre and post vaccination blood drawn within protocol-specified time frames, no major protocol violations.||titer||95% Confidence Interval|Geometric Mean
647457|NCT02124161|Primary|Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 13 Pneumococcal Serotypes|"Serotype-specific OPA GMTs for each of the 13 pneumococcal common serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were logarithmically transformed for analysis. Confidence intervals (CIs) for GMT were back-transformed based on the Student t distribution for the mean logarithm of the titers. GMTs were calculated using all participants with available data for the specified blood draw. Here, number of participants analyzed signifies the participants who were evaluable at this timepoint and n signifies participants with a determinate OPA titer to the given serotype."|1 month after Vaccination 1 for 13vPnC+QIV/Placebo, 1 Month After Vaccination 2 for Placebo+QIV/13vPnC|Evaluable immunogenicity population: eligible, randomized participants of 50 years of age or above, received all study vaccinations in assigned sequence with expected concomitant vaccination, had at least 1 valid, determinate assay results, had pre and post vaccination blood drawn within protocol-specified time frames, no major protocol violations.||titer||95% Confidence Interval|Geometric Mean
647458|NCT02124122|Primary|Mean Daily Temperature|Mean of body temperatures recorded on study days listed, averaged across all participants at all time points|Study days 1-5, 8,12, 15, 18, 28, and 36|||Degrees Celsius||Standard Deviation|Mean
647459|NCT02124122|Primary|Number of Participants With Positive Blood Culture for L Reuteri||Participants are followed an average of 36 days|||Participants|||Count of Participants
647465|NCT02123745|Primary|Red Notification Sensitivity to Infiltrated Tissues|The ratio of the number of infiltrated IV sites where the ivWatch Model 400 device issued a red notification to the total number of infiltrated IV sites in the study. All infiltrations were limited to 10 mL of isotonic saline solution.|After each participant has been infiltrated, an expected average of 1 hour|||percentage of infiltrations|Participants|95% Confidence Interval|Number
647466|NCT02123472|Secondary|Pharmacokinetics: Maximum Concentration (Cmax) of Cephalexin||Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period|All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data.||Microgram per milliliter(μg/mL)||Geometric Coefficient of Variation|Geometric Mean
647467|NCT02123472|Secondary|Pharmacokinetics: Time to Reach Maximum Observed Concentration (Tmax) of Cephalexin Following a Single Dose Maximum||Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period|All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data.||Hours||Standard Deviation|Median
647468|NCT02123472|Primary|Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of Cephalexin Following a Single Dose||Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period|All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data.||hour*microgram per milliliter (h*µg/mL)||Geometric Coefficient of Variation|Geometric Mean
647469|NCT02123459|Secondary|Pharmacokinetics: Time to Reach Maximum Observed Concentration (Tmax) of Cephalexin Following a Single Dose Maximum||Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period|All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data.||Hours||Standard Deviation|Median
647470|NCT02123459|Secondary|Pharmacokinetics: Maximum Concentration (Cmax) of Cephalexin||Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period|All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data.||μg/mL||Geometric Coefficient of Variation|Geometric Mean
647471|NCT02123459|Primary|Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of Cephalexin Following a Single Dose||Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period|All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data.||Hours*microgram per milliliter(h*μg/mL)||Geometric Coefficient of Variation|Geometric Mean
647472|NCT02123446|Secondary|Pharmacokinetics: Time to Reach Maximum Observed Concentration (Tmax) of Cephalexin Following a Single Dose Maximum||Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period|All participants who had at least one study treatment and had evaluable PK data.||hours||Standard Deviation|Median
647473|NCT02123446|Secondary|Pharmacokinetics: Maximum Concentration (Cmax) of Cephalexin||Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period|All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data.||Microgram per milliliter(µg/ml)||Geometric Coefficient of Variation|Geometric Mean
647474|NCT02123446|Primary|Pharmacokinetics: Area Under the Concentration Versus Time Curve of Cephalexin From Time Zero to Infinity [AUC(0-∞)] of Cephalexin Following a Single Dose||Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period|All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data.||Hour*microgram per milliliter(h*µg/mL)||Geometric Coefficient of Variation|Geometric Mean
647475|NCT02123017|Secondary|Tolerability of and Preference for Bisacodyl and Lactulose as a Bowel Evacuant|Tolerability assessed by a patient questionnaire. Overall tolerability as given by Visual Analog Scale (VAS): 100 represents maximally tolerable; 0 represents minimally tolerable|1 day post last consumption|||units on a VAS scale||Standard Deviation|Mean
647476|NCT02123017|Secondary|Safety of Bisacodyl and Lactulose as a Bowel evacuant_AE Severity|Safety determined by the severity of treatment emergent adverse events.|1 day post last consumption|||Percentage of subjects|||Number
647477|NCT02123017|Secondary|Safety of Bisacodyl and Lactulose as a Bowel evacuant_AE Incidence|Safety determined by the incidence of treatment emergent adverse events.|1 day post last consumption|||% of patients with adverse events|||Number
647478|NCT02123017|Primary|Efficacy of Bisacodyl and Lactulose as a Preparation for Colonoscopy.|Efficacy assessed by the physician's determination of the cleanliness of the colon using the Boston Bowel Preparation Scale (BBPS). 9 is the maximum score, representing an fully cleansed colon; 0 is the minimal score, representing a colon with no cleaning.|10-14 hours post last consumption|||units on a scale||Standard Deviation|Mean
647479|NCT02122549|Primary|Percentage of Time Rhythm Monitoring by the HWD1000 is Compromised Due to ECG Noise.|The amount of time that the HWD1000 is unable to monitor the subject's rhythm status is the primary safety measure. The specific goals are that average monitoring will be inhibited by noise no greater than 2% of the time worn (at least 24 hours) and monitoring using single lead analysis will be no greater than 5% of the time worn (at least 24 hours).|24 hours or longer|Subjects who wore the HWD 1000 for a minimum of 24 hours.||percentage of time worn||Standard Deviation|Mean
647480|NCT02122445|Secondary|Perceived Exertion|The amount of perceived exertion was reported for each of the 4 exercises (ClamsR, Sidelying, StandingAB, ForwardBend) at 3 time points (Baseline[T1], Immediate post[T2], 24hrs[T3]), by 20 subjects, totaling 240 data points. This was measured using the TheraBand(R) Resistance Intensity Scale for Exercise (RISE Scale). Participants were asked to rate their perceived exertion on a scale of 0 to 10, 0 being no resistance and 10 being maximum resistance. The results of the 20 subjects were averaged for each exercise at each time point.|Perceived Exertion|||units on a scale, from 0 to 10||Full Range|Mean
647496|NCT02121847|Primary|Change From Baseline in Working With a Computer or Bank Machine on the OSDI|The OSDI consists of 12 questions measuring the presence of ocular symptoms. The working with a computer or bank machine question is assessed using a 5-point scale (0=none of the time; 4=all of the time). The working with a computer or bank machine score is converted to a 0-100 score where 0 is best and 100 is worst. Higher OSDI reading scores are associated with greater severity. A negative number change from baseline indicates improvement and a positive number change from baseline indicates worsening.|Baseline, Month 6|Intent-to-Treat: all enrolled patients who received at least one dose of the study drug and who have data for this outcome measure||Scores on a Scale||Standard Deviation|Mean
647481|NCT02122445|Primary|Percent of Maximal Voluntary Isometric Contraction (%MVIC)|3 muscles during 4 exercises (ClamsR, Sidelying, StandingAB, ForwardBend) at 3 time points (Baseline[T1], Immediate post[T2], 24hrs[T3]), were analyzed in 20 subjects, totaling 720 data points. Maximal voluntary isometric contraction(MVIC) was assessed using the standard manual muscle testing positions. For each subject, the EMG signals of the muscles during the exercises were smoothed, rectified and analyzed using a root-mean-square algorithm and the greatest activation of each muscle was used. After the peak activation(PA) for each muscle was determined, it was compared to the MVIC of the reference exercise for the respective muscle group, and expressed as a percent of MVIC (%MVIC). In some cases the %MVIC is greater than 100% because the MVIC was assessed during a manual muscle test position. During an exercise some muscles generated greater PA and therefore when calculated the %MVIC was greater than 100%. Due to the amount of data, we have provided the Gmax %MVIC results.|% Maximal Voluntary Isometric Contracion (%MVIC)|||% of Max Voluntary Isometric Contraction||Full Range|Mean
647482|NCT02122406|Primary|Hospital Anxiety and Depression Scale (HADS)|Hospital Anxiety and Depression Scale (HADS) questionnaire. The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The anxiety and depression subscales each range from 0 to 21, with higher scores indicating higher anxiety/depression complains. Patients were defined as having anxiety or depression or both if the score was 8 or more in the corresponding subscale.|1 day of enrollement|||participants|||Number
647483|NCT02121860|Primary|Cmax|Maximum concentration (Cmax)|48 Hours|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
647484|NCT02121860|Secondary|Levels of Caspase 3/7 RLU|Concentration of Caspase 3/7 Relative Light Units|predose, 0.5, 1,2,3,4,5,8,12,24, and 48 hours post dose|||RLU||Inter-Quartile Range|Median
647485|NCT02121860|Secondary|Levels of cCK18/M30|Caspase-cleaved cytokeratin levels (cCK18M30)|predose, 0.5, 1,2,3,4,5,8,12,24, and 48 hours post dose|||U/L||Inter-Quartile Range|Median
647486|NCT02121860|Primary|AUC|Area under the plasma concentration curve (AUC) to 12 hours post-dose (AUC0-12); AUC to the last observed plasma concentration (AUClast);|48 Hours|The analyzed sample size was 36 subjects: 12 subjects with mild, and 8 subjects each with moderate and severe hepatic impairment, and with normal hepatic function.||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
647487|NCT02121847|Secondary|Change From Baseline in Conjunctival Redness in the Worse Eye|Conjunctival redness is scored in the worse eye on a numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments were allowed). A positive number change from baseline indicates a worsening and a negative number change from baseline indicates an improvement.|Baseline, Month 6|Intent-to-Treat: all enrolled patients who received at least one dose of the study drug||Scores on a Scale||Standard Deviation|Mean
647488|NCT02121847|Secondary|Change From Baseline in the Interblink Interval in the Worse Eye|The interblink interval measures the time (seconds) between blinks in the worse eye. A positive number change from baseline indicates a worsening (more frequent blinks) and a negative number change from baseline (less frequent blinks) indicates an improvement.|Baseline, Month 6|Intent-to-Treat: all enrolled patients who received at least one dose of the study drug||Seconds||Standard Deviation|Mean
647489|NCT02121847|Secondary|Change From Baseline in Tear Film Break-up Time in the Worse Eye|TFBUT is defined as the time required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A positive number change from baseline indicates improvement and a negative number change from baseline indicates a worsening.|Baseline, Month 6|Intent-to-Treat: all enrolled patients who received at least one dose of the study drug||Seconds||Standard Deviation|Mean
647490|NCT02121847|Secondary|Change From Baseline in Ocular Discomfort on a 4-point Scale|Ocular discomfort is assessed on a 4-point scale where 0=no discomfort and 3=most discomfort. A positive number change from baseline indicates a worsening and a negative number change from baseline indicates an improvement.|Baseline, Month 6|||Scores on a Scale||Standard Deviation|Mean
647491|NCT02121847|Secondary|Change From Baseline in OSDI|The OSDI consists of 12 questions measuring the presence of ocular symptoms. Each of the 12 questions is assessed using a 5-point scale (0=none of the time; 4=all of the time). The score is converted to a 0-100 score where 0 is best and 100 is worst. Higher OSDI scores are associated with greater severity. A negative number change from baseline indicates improvement and a positive number change from baseline indicates worsening.|Baseline, Month 6|Intent-to-Treat: all enrolled patients who received at least one dose of the study drug||Scores on a Scale||Standard Deviation|Mean
647492|NCT02121847|Primary|Change From Baseline in Font Size|The minimum font (letter) size read correctly is assessed. Smaller font size indicates better ability. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.|Baseline, Month 6|Intent-to-Treat: all enrolled patients who received at least one dose of the study drug||Size||Standard Deviation|Mean
647493|NCT02121847|Primary|Change From Baseline in Words Read Incorrectly|The numbers of words read incorrectly are counted in 2 minutes. A positive change from baseline indicates a worsening, and a negative change from baseline indicates an improvement.|Baseline, Month 6|Intent-to-Treat: all enrolled patients who received at least one dose of the study drug||Words||Standard Deviation|Mean
647494|NCT02121847|Primary|Change From Baseline in Reading Rate|Reading speed is assessed as the number of words read correctly in 2 minutes.|Baseline, Month 6|Intent-to-Treat: all enrolled patients who received at least one dose of the study drug||Words/Minute||Standard Deviation|Mean
647495|NCT02121847|Primary|Change From Baseline in Watching TV on the OSDI|The OSDI consists of 12 questions measuring the presence of ocular symptoms. The watching TV question is assessed using a 5-point scale (0=none of the time; 4=all of the time). The watching TV score is converted to a 0-100 score where 0 is best and 100 is worst. Higher OSDI reading scores are associated with greater severity. A negative number change from baseline indicates improvement and a positive number change from baseline indicates worsening.|Baseline, Month 6|Intent-to-Treat: all enrolled patients who received at least one dose of the study drug and who have data for this outcome measure||Scores on a Scale||Standard Deviation|Mean
647514|NCT02121535|Primary|Cmax for Hydrochlorothiazide|Cmax (maximum measured concentration of the analyte in plasma)|3hours(h) before drug administration and 15minutes (m), 30m, 45m, 1h, 1h30m, 2h, 2h30m, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug administration|PKS||ng/mL||Geometric Coefficient of Variation|Geometric Mean
650320|NCT02058498|Secondary|Quality of Life at Baseline, 6 Weeks, and 4 Months|Participants reported their perceived quality of life using a scale 1 - 10, with 1 being the worst and 10 being the best.|Baseline, 6 weeks, 4 months|||units on a scale||Standard Deviation|Mean
647497|NCT02121847|Primary|Change From Baseline in Driving at Night on the OSDI|The OSDI consists of 12 questions measuring the presence of ocular symptoms. The driving at night question is assessed using a 5-point scale (0=none of the time; 4=all of the time). The driving at night score is converted to a 0-100 score where 0 is best and 100 is worst. Higher OSDI reading scores are associated with greater severity. A negative number change from baseline indicates improvement and a positive number change from baseline indicates worsening.|Baseline, Month 6|Intent-to-Treat: all enrolled patients who received at least one dose of the study drug and who have data for this outcome measure||Scores on a Scale||Standard Deviation|Mean
647498|NCT02121847|Primary|Change From Baseline in Reading on the Ocular Surface Disease Index (OSDI)|The OSDI consists of 12 questions measuring the presence of ocular symptoms. The reading question is assessed using a 5-point scale (0=none of the time; 4=all of the time). The reading score is converted to a 0-100 score where 0 is best and 100 is worst. Higher OSDI reading scores are associated with greater severity. A negative number change from baseline indicates improvement and a positive number change from baseline indicates worsening.|Baseline, Month 6|Intent-to-Treat: all enrolled patients who received at least one dose of the study drug||Scores on a Scale||Standard Deviation|Mean
647499|NCT02121847|Primary|Change From Baseline in Total Conjunctival Staining Score With Lissamine Green in the Worse Eye|Total conjunctival staining with lissamine is measured in the worse eye utilizing the Ora CalibraTM Conjunctiva Lissamine Staining Scale (0 to 4 scale where 0=no staining and 4= severe staining). The sum of the total includes 2 regions of the conjunctiva, resulting in a maximum possible score of 8 (severe staining score of 4 in both regions). A negative change from baseline represents a decrease in staining (improvement). A positive change from baseline represents an increase in staining (worsening).|Baseline, Month 6|Intent-to-Treat: all enrolled patients who received at least one dose of the study drug||Scores on a Scale||Standard Deviation|Mean
647500|NCT02121847|Primary|Change From Baseline in Total Corneal Staining Score With Lissamine Green in the Worse Eye|Total corneal staining with lissamine green is measured in the worse eye utilizing the Ora CalibraTM Corneal Lissamine Staining Scale (0 to 4 scale where 0=no staining and 4= severe staining). The sum of the total includes 3 regions of the cornea, resulting in a maximum possible score of 12 (severe staining score of 4 in all three regions). A negative change from baseline represents a decrease in staining (improvement). A positive change from baseline represents an increase in staining (worsening).|Baseline, Month 6|Intent-to-Treat: all enrolled patients who received at least one dose of the study drug||Scores on a Scale||Standard Deviation|Mean
647501|NCT02121847|Primary|Change From Baseline in Total Conjunctival Staining Score With Fluorescein in the Worse Eye|Total conjunctival staining with fluorescein is measured in the worse eye utilizing the Ora CalibraTM Conjunctiva Flourescein Staining Scale (0 to 4 scale where 0=no staining and 4= severe staining). The sum of the total includes 2 regions of the conjunctiva, resulting in a maximum possible score of 8 (severe staining score of 4 in both regions). A negative change from baseline represents a decrease in staining (improvement). A positive change from baseline represents an increase in staining (worsening).|Baseline, Month 6|Intent-to-Treat: all enrolled patients who received at least one dose of the study drug||Scores on a Scale||Standard Deviation|Mean
647502|NCT02121847|Primary|Change From Baseline in Total Corneal Staining Score With Fluorescein in the Worse Eye|Total corneal staining with fluorescein is measured in the worse eye utilizing the Ora CalibraTM Corneal Flourescein Staining Scale (0 to 4 scale where 0=no staining and 4= severe staining). The sum of the total includes 3 regions of the cornea, resulting in a maximum possible score of 12 (severe staining score of 4 in all three regions). A negative change from baseline represents a decrease in staining (improvement). A positive change from baseline represents an increase in staining (worsening).|Baseline, Month 6|Intent-to-Treat: all enrolled patients who received at least one dose of the study drug||Scores on a Scale||Standard Deviation|Mean
647503|NCT02121795|Secondary|Change From Baseline in CD4+ Cell Count at Week 96||Baseline; Week 96||||||
647504|NCT02121795|Secondary|Percent Change From Baseline in Hip and Spine BMD at Week 96||Baseline; Week 96||||||
647505|NCT02121795|Secondary|Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 96 as Defined by the FDA Snapshot Analysis||Week 96||||||
647506|NCT02121795|Secondary|Percent of Participants With HIV-1 RNA < 20 Copies/mL at Week 96 as Defined by the FDA Snapshot Analysis||Week 96||||||
647507|NCT02121795|Secondary|Change From Baseline in CD4+ Cell Count at Week 48||Baseline; Week 48|Participants in the Full Analysis Set with on-treatment data were analyzed.||cells/μL||Standard Deviation|Mean
647508|NCT02121795|Secondary|Percent of Participants With HIV-1 RNA < 20 Copies/mL at Week 48 as Defined by the FDA Snapshot Analysis||Week 48|Full Analysis Set||percentage of participants|||Number
647509|NCT02121795|Secondary|Percent Change From Baseline in Spine BMD at Week 48|Hip BMD was assessed by dual energy x-ray absorptiometry (DXA) scan.|Baseline; Week 48|Participants in the Spine DXA Analysis Set (participants who were randomized and received ≥ 1 dose of study drug and had nonmissing baseline spine BMD) with available data were analyzed.||percentage change in spine BMD (g/cm^2)||Standard Deviation|Mean
647510|NCT02121795|Secondary|Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48|Hip BMD was assessed by dual energy x-ray absorptiometry (DXA) scan.|Baseline; Week 48|Participants in the Hip DXA Analysis Set (participants who were randomized and received ≥ 1 dose of study drug and had nonmissing baseline hip BMD) with available data were analyzed.||percentage of change in hip BMD (g/cm^2)||Standard Deviation|Mean
647511|NCT02121795|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the FDA Snapshot Analysis||Week 48|Full Analysis Set: all participants who were randomized into the study and received at least 1 dose of study drug||Percentage of participants|||Number
647512|NCT02121535|Secondary|AUC0-∞ for Hydrochlorothiazide|AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)|3hours(h) before drug administration and 15minutes (m), 30m, 45m, 1h, 1h30m, 2h, 2h30m, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug administration|PKS||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
647513|NCT02121535|Primary|AUC0-tz for Hydrochlorothiazide|AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)|3hours(h) before drug administration and 15minutes (m), 30m, 45m, 1h, 1h30m, 2h, 2h30m, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug administration|PKS||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
647516|NCT02121535|Primary|AUC0-tz for Amlodipine|AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)|3hours(h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h, 96h, 120h, 144h after drug administration|PKS||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
647517|NCT02121535|Secondary|AUC0-∞ for Amlodipine|AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)|3hours(h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h, 96h, 120h, 144h after drug administration|PKS||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
647518|NCT02121535|Secondary|AUC0-∞ for Telmisartan|AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)|3hours(h) before drug administration and 15minutes (m), 30m, 45m, 1h, 1h30m, 2h, 2h30m, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h after drug administration|PKS||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
647519|NCT02121535|Primary|Cmax for Telmisartan|Cmax (maximum measured concentration of the analyte in plasma)|3hours(h) before drug administration and 15minutes (m), 30m, 45m, 1h, 1h30m, 2h, 2h30m, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h after drug administration|PKS||ng/mL||Geometric Coefficient of Variation|Geometric Mean
647520|NCT02121535|Primary|Area Under the Concentration-time Curve of the Telmisartan in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point (AUC0-tz)|Area under the concentration-time curve of the telmisartan in plasma over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz)|3hours(h) before drug administration and 15minutes (m), 30m, 45m, 1h, 1h30m, 2h, 2h30m, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h after drug administration|"Pharmacokinetic set (PKS):
included all subjects in the TS who had evaluable pharmacokinetic (PK) variables for both test drug and reference drugs. Subjects who had an important protocol violation (PV) for relevant PK evaluation were excluded from the PKS."||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
647521|NCT02121522|Secondary|Change From Baseline in Neovascular Leakage Area as Assessed by FA on Day 29|Change from baseline in neovascular leakage area as assessed by Fluorescein angiography (FA) on day 29. Baseline is defined as the last value collected before the first trial drug intake. Data collected after start of wet age-related macular degeneration (wAMD) therapy are set to missing.|Baseline and day 29|Treated set (OC). Observed Case (OC): This method analysed only available data that were observed while patients were on treatment, ie., missing data were not imputed.||mm²||Standard Deviation|Mean
647522|NCT02121522|Primary|Change From Baseline in CRT as Measured by SD-OCT on Day 29|Change from baseline in central 1-mm retinal thickness (CRT) as measured by spectral domain optical coherence tomography (SD-OCT) on day 29.|Baseline (day 1) and day 29|Treated set (WOCF). Missing values are imputed by the worst observation carried forward (WOCF) measurement (including baseline).||μm||Standard Deviation|Mean
647523|NCT02121509|Secondary|AUC0-inf of Metformin in Plasma|"AUC0−inf(area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) for Metformin.
The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS 1500 fast and PKS 1500 fed, included all treated subjects in Part 1 and Part 2, respectively, who provided at least 1 observation for at least 1 primary endpoint, without important protocol violations regarding the statistical evaluation of pharmacokinetic endpoints.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
647524|NCT02121509|Secondary|Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)|"AUC0−inf (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) for Linagliptin.
The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS 1500 fast and PKS 1500 fed, included all treated subjects in Part 1 and Part 2, respectively, who provided at least 1 observation for at least 1 primary endpoint, without important protocol violations regarding the statistical evaluation of pharmacokinetic endpoints.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
647525|NCT02121509|Primary|Cmax of Metformin in Plasma|Cmax (maximum measured concentration of the Metformin in plasma) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS 1500 fast and PKS 1500 fed, included all treated subjects in Part 1 and Part 2, respectively, who provided at least 1 observation for at least 1 primary endpoint, without important protocol violations regarding the statistical evaluation of pharmacokinetic endpoints.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
647526|NCT02121509|Primary|Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)|AUC 0-tz (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS 1500 fast and PKS 1500 fed, included all treated subjects in Part 1 and Part 2, respectively, who provided at least 1 observation for at least 1 primary endpoint, without important protocol violations regarding the statistical evaluation of pharmacokinetic endpoints.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
647551|NCT02120833|Secondary|Caregiver Questionnaire on Day 14 – Overall, my Baby’s Skin Looks Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|14 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
647527|NCT02121509|Primary|Maximum Measured Concentration of Linagliptin in Plasma (Cmax)|Cmax (maximum measured concentration of Linagliptin in plasma) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS 1500 fast and PKS 1500 fed, included all treated subjects in Part 1 and Part 2, respectively, who provided at least 1 observation for at least 1 primary endpoint, without important protocol violations regarding the statistical evaluation of pharmacokinetic endpoints.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
647528|NCT02121509|Primary|Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval From 0 to 72 Hours (AUC0-72)|AUC 0-72 (area under the concentration-time curve of the Linagliptin in plasma from 0 to 72 hours) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS1500 Fast and PKS1500 Fed, included all treated subjects in Part 1 and Part 2, who provided at least 1 observation for at least 1 primary endpoint, without important protocol violations regarding the statistical evaluation of pharmacokinetic endpoints.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
647529|NCT02121483|Secondary|Change From Baseline in 8-point Plasma Glucose Profile Over 24 h After Study Drug Intake|"Change from baseline in 8-point plasma glucose profile over 24h after study drug intake (as defined by change from baseline in Mean Daily Glucose (MDG) calculated at Day 1).
For the changes from baseline in MDG on Day 1, adjusted means per treatment group were to be calculated based on an ANCOVA including ‘treatment’ as fixed effect and ‘MDG at baseline’ as continuous covariate.
Means presented are the adjusted means."|baseline and 24 hours|Treated Set (TS) including patients with plasma glucose profile data on both visits||mg/dL||Standard Error|Mean
647530|NCT02121483|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at 24 h After Study Drug Intake|"Change from baseline in Fasting Plasma Glucose (FPG) at 24h after study drug intake.
For the change from baseline in FPG at 24 h postdose (in the morning of Day 2), adjusted means per treatment group were to be calculated based on an ANCOVA including ‘treatment’ as a fixed effect and ‘FPG at baseline’ as continuous covariate.
Means presented are the adjusted means."|baseline and 24 hours|Treated Set (TS) including patients with FPG data on both visits||mg/dL||Standard Error|Mean
647531|NCT02121483|Secondary|Change From Baseline in Urinary Glucose Excretion (UGE) Over 24 h After Study Drug Intake|"Change from baseline in Urinary Glucose Excretion (UGE) over 24 h after study drug intake.
For the changes from baseline in UGE on Day 1 (0 to 24 h postdose) , adjusted means per treatment group were to be calculated based on an ANCOVA including ‘treatment’ as a fixed effect and ‘UGE at baseline’ and ‘FPG at baseline’ as continuous covariates. Means presented are the adjusted means."|baseline and 24 hours|Treated Set (TS) including patients with UGE data on both visits||g/24h||Standard Error|Mean
647532|NCT02121483|Primary|t1/2|Terminal half-life in plasma (t1/2).|Before drug administration (-0:30 hours (h)) and 0:30h, 1:00h, 1:30h, 2:00h, 4:00h, 8:00h, 12:00 (Day 1), 24:00 (Day 2), 34:00 (Day 2), 48:00 (Day 3) after drug administration.|Pharmacokinetic Set (PKS): The PKS included all treated patients who provided at least 1 primary or secondary pharmacokinetic parameter for statistical assessment.||hours||Geometric Coefficient of Variation|Geometric Mean
647533|NCT02121483|Primary|Tmax|Maximum measured concentration in plasma (tmax).|Before drug administration (-0:30 hours (h)) and 0:30h, 1:00h, 1:30h, 2:00h, 4:00h, 8:00h, 12:00 (Day 1), 24:00 (Day 2), 34:00 (Day 2), 48:00 (Day 3) after drug administration.|Pharmacokinetic Set (PKS): The PKS included all treated patients who provided at least 1 primary or secondary pharmacokinetic parameter for statistical assessment.||hours||Full Range|Median
647534|NCT02121483|Primary|Cmax|Maximum measured concentration in plasma (Cmax).|Before drug administration (-0:30 hours (h)) and 0:30h, 1:00h, 1:30h, 2:00h, 4:00h, 8:00h, 12:00 (Day 1), 24:00 (Day 2), 34:00 (Day 2), 48:00 (Day 3) after drug administration.|Pharmacokinetic Set (PKS): The PKS included all treated patients who provided at least 1 primary or secondary pharmacokinetic parameter for statistical assessment.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
647535|NCT02121483|Primary|AUC0-tz|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable concentration (AUC0-tz).|Before drug administration (-0:30 hours (h)) and 0:30h, 1:00h, 1:30h, 2:00h, 4:00h, 8:00h, 12:00 (Day 1), 24:00 (Day 2), 34:00 (Day 2), 48:00 (Day 3) after drug administration.|Pharmacokinetic Set (PKS): The PKS included all treated patients who provided at least 1 primary or secondary pharmacokinetic parameter for statistical assessment.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
647536|NCT02121483|Primary|AUC0-inf|Area under the concentration-time curve of analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf).|Before drug administration (-0:30 hours (h)) and 0:30h, 1:00h, 1:30h, 2:00h, 4:00h, 8:00h, 12:00 (Day 1), 24:00 (Day 2), 34:00 (Day 2), 48:00 (Day 3) after drug administration.|Pharmacokinetic Set (PKS): The PKS included all treated patients who provided at least 1 primary or secondary pharmacokinetic parameter for statistical assessment.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
647537|NCT02121210|Secondary|Serum Sarilumab Concentration|Trough Concentration (Ctrough).|Pre-dose at Week 0 (Baseline), 2, 4, 12, 16, 20, 24 and 30|Analysis was performed on pharmacokinetic (PK) population consisted of all randomized population actually received at least one or partial dose of IMP, with at least one post-dose, non-missing serum sarilumab concentration. Number of participants analyzed=participants with serum sarilumab concentration assessment at specified time-points.||ng/mL||Standard Deviation|Mean
647552|NCT02120833|Secondary|Caregiver Questionnaire on Day 7 – In the Areas Affected by Eczema, my Baby's Skin Feels Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|7 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
647751|NCT02118597|Secondary|Percentage of Participants With Virological Response|Virological response is defined as HCV RNA <15 IU/mL.|Weeks 4, 8, 12, and 24|Intent to treat (ITT) population included all enrolled participants. Here, 'n' indicated number of participants with virological response data at evaluated time points.||percentage of participants|||Number
647538|NCT02121210|Primary|Percentage of Participants With Incidence of Antidrug Antibodies (ADA)|ADA to sarilumab and anti-sarilumab neutralizing antibodies in serum samples were determined using a validated electrochemiluminescence immunoassay method. Percentage of participants with positive ADA during treatment emergent adverse event (TEAE) period (time from first dose of investigational medicinal product [IMP] to last dose of IMP + 60 days) was determined. Persistent ADA Response: treatment-emergent ADA detected at 2 or more consecutive sampling time points during the TEAE period, where the first and last ADA positive samples were separated by a period of at least 16 weeks or if the last measured sample was positive. ADA samples were collected prior to IMP administration at Week 0 (baseline), Week 2, 4, 12, 24 and 30.|From Baseline to Week 30 [End of study (EOS)]|Analysis was performed on immunogenicity population included all randomized participants who received at least one dose of sarilumab with at least one post-dose, evaluable ADA sample.||Percentage of participants|||Number
647539|NCT02121067|Secondary|Number of Participants With Expulsion (Complete or Partial) of LNG-IUS at Six-months.|Expulsion will be defined as any of the following (1) patient report that the LNG-IUS came out, (2) ultrasound evaluation that demonstrates the LNG-IUS is not intrauterine (3) ultrasound or clinical evaluation that demonstrates the majority of the LNG-IUS is located in the cervix.|6 months postpartum|Of the 50 participants who enrolled and had an LNG-IUS placed at 2 weeks postpartum, only 43 were available at 6 months postpartum to provide data for expulsion.||Participants|||Count of Participants
647540|NCT02121067|Primary|Number of Participants Who Enrolled and Were Able to Have a Successful LNG-IUS Insertion in the 2 Week (Day 14-20) Postpartum Period.|Was the LNG-IUS successfully placed in the study period, as determined by whether the participant had an LNG-IUS placed on the day of insertion?|Day 14-20 postpartum|||Participants|||Count of Participants
647541|NCT02121067|Primary|Number of Participants Who Would Recommend the LNG-IUS to a Friend at 6-months Postpartum.|A dichotomous, yes/no answer to the following question “Would you recommend Mirena placement at two-weeks postpartum to a friend?”|6 months postpartum|Of the 50 participants who enrolled, only 43 were available at 6 months postpartum to provide data for the first primary outcome.||Participants|||Count of Participants
647542|NCT02121041|Primary|24 Hour Blood Pressure Average at the End of 4 Month Participation.||Participants will be on study average of 4 months.|||mm Hg||Standard Deviation|Mean
647543|NCT02120833|Secondary|Caregiver Questionnaire on Day 14 – I Would Recommend This Product to Another Parent.|Questions were answered immediately post-treatment by participant’s caregiver. Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|14 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
647544|NCT02120833|Secondary|Caregiver Questionnaire on Day 14 – In the Areas Affected by Eczema, my Baby's Skin Feels Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|14 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
647545|NCT02120833|Secondary|Caregiver Questionnaire on Day 14 – In the Areas Affected by Eczema, my Baby's Skin Feels Soft|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|14 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
647546|NCT02120833|Secondary|Caregiver Questionnaire on Day 14 – In the Areas Affected by Eczema, my Baby's Skin Looks Healthy|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|14 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
647547|NCT02120833|Secondary|Caregiver Questionnaire on Day 14 – In the Areas Affected by Eczema, my Baby's Skin Looks Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|14 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
647548|NCT02120833|Secondary|Caregiver Questionnaire on Day 14 – Overall, my Baby’s Skin Feels Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|14 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
647549|NCT02120833|Secondary|Caregiver Questionnaire on Day 14 – Overall, my Baby’s Skin Feels Soft|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|14 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
647550|NCT02120833|Secondary|Caregiver Questionnaire on Day 14 – Overall, my Baby’s Skin Looks Healthy|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|14 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
648289|NCT02106962|Primary|Clotting TIme|After completing dialysis, the clotting time of the arteriovenous fistula of each participant was measured, using either Tranexamic Acid 5% or Tranexamic Acid 25% and compared to the regular clotting time of the AV Fistula without using the Tranexamic Acid|13 minutes|||minutes||Full Range|Mean
647553|NCT02120833|Secondary|Caregiver Questionnaire on Day 7 – In the Areas Affected by Eczema, my Baby's Skin Feels Soft|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|7 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
647554|NCT02120833|Secondary|Caregiver Questionnaire on Day 7 – In the Areas Affected by Eczema, my Baby's Skin Looks Healthy|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|7 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
647555|NCT02120833|Secondary|Caregiver Questionnaire on Day 7 – In the Areas Affected by Eczema, my Baby's Skin Looks Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|7 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
647556|NCT02120833|Secondary|Caregiver Questionnaire on Day 7 – Overall, my Baby’s Skin Feels Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|7 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
647557|NCT02120833|Secondary|Caregiver Questionnaire on Day 7 – Overall, my Baby’s Skin Feels Soft|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|7 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
647558|NCT02120833|Secondary|Caregiver Questionnaire on Day 7 – Overall, my Baby’s Skin Looks Healthy|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|7 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
647559|NCT02120833|Secondary|Caregiver Questionnaire on Day 7 – Overall, my Baby’s Skin Looks Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|7 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
647560|NCT02120833|Secondary|Caregiver Questionnaire on Day 3 – In the Areas Affected by Eczema, my Baby's Skin Feels Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|3 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
647561|NCT02120833|Secondary|Caregiver Questionnaire on Day 3 – In the Areas Affected by Eczema, my Baby's Skin Feels Soft|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|3 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
647562|NCT02120833|Secondary|Caregiver Questionnaire on Day 3 – In the Areas Affected by Eczema, my Baby's Skin Looks Healthy|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|3 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
647563|NCT02120833|Secondary|Caregiver Questionnaire on Day 3 – In the Areas Affected by Eczema, my Baby's Skin Looks Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|3 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
647564|NCT02120833|Secondary|Caregiver Questionnaire on Day 3 – Overall, my Baby’s Skin Feels Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|3 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
647613|NCT02120833|Secondary|Eczema Area and Severity Index (EASI) on Day 7 - Change From Baseline|The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72.|Baseline to Day 7|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||units on a scale||Standard Deviation|Mean
647565|NCT02120833|Secondary|Caregiver Questionnaire on Day 3 – Overall, my Baby’s Skin Feels Soft|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|3 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
647566|NCT02120833|Secondary|Caregiver Questionnaire on Day 3 – Overall, my Baby’s Skin Looks Healthy|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|3 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
647567|NCT02120833|Secondary|Caregiver Questionnaire on Day 3 – Overall, my Baby’s Skin Looks Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|3 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
647568|NCT02120833|Secondary|Caregiver Questionnaire on Day 2 – In the Areas Affected by Eczema, my Baby's Skin Feels Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|2 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
647569|NCT02120833|Secondary|Caregiver Questionnaire on Day 2 – In the Areas Affected by Eczema, my Baby's Skin Feels Soft|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|2 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
647570|NCT02120833|Secondary|Caregiver Questionnaire on Day 2 – In the Areas Affected by Eczema, my Baby's Skin Looks Healthy|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|2 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
647571|NCT02120833|Secondary|Caregiver Questionnaire on Day 2 – In the Areas Affected by Eczema, my Baby's Skin Looks Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|2 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
647572|NCT02120833|Secondary|Caregiver Questionnaire on Day 2 – Overall, my Baby’s Skin Feels Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|2 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
647573|NCT02120833|Secondary|Caregiver Questionnaire on Day 2 – Overall, my Baby’s Skin Feels Soft|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|2 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
647574|NCT02120833|Secondary|Caregiver Questionnaire on Day 2 – Overall, my Baby’s Skin Looks Healthy|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|2 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
647575|NCT02120833|Secondary|Caregiver Questionnaire on Day 2 – Overall, my Baby’s Skin Looks Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|2 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
647576|NCT02120833|Secondary|Caregiver Questionnaire on Day 1 – In the Areas Affected by Eczema, my Baby's Skin Feels Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|1 Day|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
647577|NCT02120833|Secondary|Caregiver Questionnaire on Day 1 – In the Areas Affected by Eczema, my Baby's Skin Feels Soft|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|1 Day|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
647578|NCT02120833|Secondary|Caregiver Questionnaire on Day 1 – In the Areas Affected by Eczema, my Baby's Skin Looks Healthy|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|1 Day|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
647579|NCT02120833|Secondary|Caregiver Questionnaire on Day 1 – In the Areas Affected by Eczema, my Baby's Skin Looks Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|1 Day|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
647580|NCT02120833|Secondary|Caregiver Questionnaire on Day 1 – Overall, my Baby’s Skin Feels Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|1 Day|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
647581|NCT02120833|Secondary|Caregiver Questionnaire on Day 1 – Overall, my Baby’s Skin Feels Soft|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|1 Day|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
647582|NCT02120833|Secondary|Caregiver Questionnaire on Day 1 – Overall, my Baby’s Skin Looks Healthy|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|1 Day|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
647583|NCT02120833|Secondary|Caregiver Questionnaire on Day 1 – Overall, my Baby’s Skin Looks Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|1 Day|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
647584|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Post-treatment – In the Areas Affected by Eczema, my Baby's Skin Feels Soft and Smooth Instantly|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|0 Days - Post-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
647585|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Post-treatment – In the Areas Affected by Eczema, my Baby's Skin Feels Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|0 Days - Post-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
647586|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Post-treatment – In the Areas Affected by Eczema, my Baby's Skin Feels Soft|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|0 Days - Post-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
647587|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Post-treatment – In the Areas Affected by Eczema, my Baby's Skin Looks Healthy|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|0 Days - Post-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
647588|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Post-treatment – In the Areas Affected by Eczema, my Baby's Skin Looks Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|0 Days - Post-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
647589|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Post-treatment – Overall, my Baby’s Skin Feels Soft and Smooth Instantly|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|0 Days - Post-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
647638|NCT02120300|Secondary|Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, 12, 16, 20, and 24||Baseline; Weeks 1, 2, 4, 8, 12, 16, 20, and 24|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
647590|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Post-treatment – Overall, my Baby’s Skin Feels Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|0 Days - Post-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
647591|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Post-treatment – Overall, my Baby’s Skin Feels Soft|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|0 Days - Post-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
647592|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Post-treatment – Overall, my Baby’s Skin Looks Healthy|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|0 Days - Post-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
647593|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Post-treatment – Overall, my Baby’s Skin Looks Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|0 Days - Post-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
647594|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment – In the Areas Affected by Eczema, my Baby's Skin Feels Smooth|Questions were answered before treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|0 Days - Pre-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
647595|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment – In the Areas Affected by Eczema, my Baby's Skin Feels Soft|Questions were answered before treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|0 Days - Pre-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
647596|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment – In the Areas Affected by Eczema, my Baby's Skin Looks Healthy|Questions were answered before treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|0 Days - Pre-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
647597|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment – In the Areas Affected by Eczema, my Baby's Skin Looks Smooth|Questions were answered before treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|0 Days - Pre-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
647598|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment – Overall, my Baby’s Skin Feels Smooth|Questions were answered before treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|0 Days - Pre-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
647599|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment – Overall, my Baby’s Skin Feels Soft|Questions were answered before treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|0 Days - Pre-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
647600|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment – Overall, my Baby’s Skin Looks Healthy|Questions were answered before treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|0 Days - Pre-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
647601|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment – Overall, my Baby’s Skin Looks Smooth|Questions were answered before treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|0 Days - Pre-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
647639|NCT02120300|Secondary|Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24||Weeks 1, 2, 4, 8, 12, 16, 20, and 24|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants|||Number
647602|NCT02120833|Secondary|Corneometer Measurement on Day 14 - Change From Baseline|Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to eczema-affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated. Pre-treatment readings ranged from 2.0 to 68.0. On Day 14, corneometer readings ranged from 5.7 to 73.1.|Baseline to Day 14|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||arbitrary units||Standard Deviation|Mean
647603|NCT02120833|Secondary|Corneometer Measurement on Day 7 - Change From Baseline|Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to eczema-affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated. Pre-treatment readings ranged from 2.0 to 68.0. On Day 7, corneometer readings ranged from 6.8 to 65.0.|Baseline to Day 7|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||arbitrary units||Standard Deviation|Mean
647604|NCT02120833|Secondary|Corneometer Measurement on Day 3 - Change From Baseline|Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to eczema-affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated. Pre-treatment readings ranged from 2.0 to 68.0. On Day 3, corneometer readings ranged from 8.0 to 65.3.|Baseline to Day 3|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||arbitrary units||Standard Deviation|Mean
647605|NCT02120833|Secondary|Corneometer Measurement on Day 2 - Change From Baseline|Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to eczema-affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated. Pre-treatment readings ranged from 2.0 to 68.0. On Day 2, corneometer readings ranged from 8.5 to 74.0.|Baseline to Day 2|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||arbitrary units||Standard Deviation|Mean
647606|NCT02120833|Secondary|Corneometer Measurement on Day 1 - Change From Baseline|Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to eczema-affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated. Pre-treatment readings ranged from 2.0 to 68.0. On Day 1, corneometer readings ranged from 5.5 to 84.0.|Baseline to Day 1|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||arbitrary units||Standard Deviation|Mean
647607|NCT02120833|Secondary|Corneometer Measurement on Day 0 – Post-Treatment - Change From Baseline|Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to eczema-affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated. Pre-treatment readings ranged from 2.0 to 68.0. Post-treatment on Day 0, corneometer readings ranged from 10.3 to 86.3.|Baseline to Post -Treatment on Day 0|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||arbitrary units||Standard Deviation|Mean
647608|NCT02120833|Secondary|Investigator’s Global Atopic Dermatitis Assessment (IGADA) on Day 14 - Change From Baseline|The signs and symptoms of eczema are measured using the Investigator’s Global Atopic Dermatitis Assessment (IGADA). An assessment of atopic dermatitis based on a 4 point scale, ranging from 0 (none) and 3 (severe), is used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating is categorized as clear, almost clear, mild, moderate, severe, or very severe.|Baseline to Day 14|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||units on a scale||Standard Deviation|Mean
647609|NCT02120833|Secondary|Investigator’s Global Atopic Dermatitis Assessment (IGADA) on Day 7 - Change From Baseline|The signs and symptoms of eczema are measured using the Investigator’s Global Atopic Dermatitis Assessment (IGADA). An assessment of atopic dermatitis based on a 4 point scale, ranging from 0 (none) and 3 (severe), is used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating is categorized as clear, almost clear, mild, moderate, severe, or very severe.|Baseline to Day 7|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||units on a scale||Standard Deviation|Mean
647610|NCT02120833|Secondary|Investigator’s Global Atopic Dermatitis Assessment (IGADA) on Day 2 - Change From Baseline|The signs and symptoms of eczema are measured using the Investigator’s Global Atopic Dermatitis Assessment (IGADA). An assessment of atopic dermatitis based on a 4 point scale, ranging from 0 (none) and 3 (severe), is used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating is categorized as clear, almost clear, mild, moderate, severe, or very severe.|Baseline to Day 2|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||units on a scale||Standard Deviation|Mean
647611|NCT02120833|Secondary|Investigator’s Global Atopic Dermatitis Assessment (IGADA) on Day 1 - Change From Baseline|The signs and symptoms of eczema are measured using the Investigator’s Global Atopic Dermatitis Assessment (IGADA). An assessment of atopic dermatitis based on a 4 point scale, ranging from 0 (none) and 3 (severe), is used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating is categorized as clear, almost clear, mild, moderate, severe, or very severe.|Baseline to Day 1|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||units on a scale||Standard Deviation|Mean
647612|NCT02120833|Secondary|Eczema Area and Severity Index (EASI) on Day 14 - Change From Baseline|The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72.|Baseline to Day 14|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||units on a scale||Standard Deviation|Mean
647640|NCT02120300|Secondary|Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)|SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.|Posttreatment Week 4|Full Analysis Set||percentage of participants||95% Confidence Interval|Number
647614|NCT02120833|Secondary|Eczema Area and Severity Index (EASI) on Day 2 - Change From Baseline|The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72.|Baseline to Day 2|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||units on a scale||Standard Deviation|Mean
647615|NCT02120833|Secondary|Eczema Area and Severity Index (EASI) on Day 1 - Change From Baseline|The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72.|Baseline to Day 1|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||units on a scale||Standard Deviation|Mean
647616|NCT02120833|Primary|Investigator’s Global Atopic Dermatitis Assessment (IGADA) on Day 3 - Change From Baseline|The signs and symptoms of eczema are measured using the Investigator’s Global Atopic Dermatitis Assessment (IGADA). An assessment of atopic dermatitis based on a 4 point scale, ranging from 0 (none) and 3 (severe), is used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating is categorized as clear, almost clear, mild, moderate, severe, or very severe.|Baseline to Day 3|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||units on a scale||Standard Deviation|Mean
647617|NCT02120833|Primary|Eczema Area and Severity Index (EASI) on Day 3 - Change From Baseline|The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72.|Baseline to Day 3|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||units on a scale||Standard Deviation|Mean
647618|NCT02120664|Secondary|Variability of PET Images in Young Healthy Control Subjects.|Coefficient of variation for 11C-PiB and florbetapir (18F) SUVr. A cortical average to cerebellum SUVr was used for this outcome measure.|up to 70 minutes post injection|Young healthy controls enrolled in the study||SUVr||Standard Deviation|Mean
647619|NCT02120664|Secondary|Correlation of Florbetapir (18F) Centiloid and 11C-PiB Centiloid|Correlation coefficient between 11C-PiB and florbetapir (18F) SUVr as converted to centiloid units. The Centiloid is anchored at values of 0 and 100 corresponding to the median Pittsburgh Compound B (11C-PiB) SUVr value for a representative group of young (<45) cognitively and medically healthy control subjects (YHC) and the median SUVr value for a representative group of 11C-PiB positive patients diagnosed with Alzheimer’s disease, respectively. A cortical average to cerebellum SUVr was used for this outcome measure.|up to 70 minutes post injection|All participants receiving both a florbetapir and a PiB scan per protocol. One subject in the possible AD group did not complete the florbetapir scan due to excessive movement. One subject in the at risk elderly group elected to leave the study before the second PET scan.||centiloid||Standard Deviation|Mean
647620|NCT02120664|Primary|Florbetapir SUVr Conversion to Centiloid Units|Conversion of florbetapir (18F) positron emission tomography (PET) standard uptake value ratio (SUVr) to Centiloid units. The Centiloid is anchored at values of 0 and 100 corresponding to the median Pittsburgh Compound B (11C-PiB) SUVr value for a representative group of young (<45) cognitively and medically healthy control subjects (YHC) and the median SUVr value for a representative group of 11C-PiB positive patients diagnosed with Alzheimer’s disease, respectively. A cortical average to cerebellum SUVr was used for this outcome measure.|up to 70 minutes post injection|All participants receiving both a florbetapir and a PiB scan per protocol. One subject in the possible AD group did not complete a florbetapir scan due to excessive movement. One subject in the at risk elderly group elected to leave the study before the second PET scan.||centiloid||Standard Deviation|Mean
647621|NCT02120625|Secondary|Number of Participants With Serious and Non-Serious Adverse Events||Up to 6 weeks|||Participants|||Count of Participants
647622|NCT02120625|Primary|EMG Evidence of Lesion of the Targeted Medial Branches|EMG evidence of lesion of the targeted medial branches (Percentage of positive lesions)|3-6 weeks post radiofrequency ablation|||percentage of lesions|Lesions|95% Confidence Interval|Number
647623|NCT02120625|Primary|Volume of Lesions Were Recorded by the Reading Radiologists|Volume of lesions were recorded by the reading radiologists, including proximity to medial branches|7 days|||cubic millimeters||95% Confidence Interval|Mean
647624|NCT02120625|Primary|Percentage of Patients With Magnetic Resonance Imaging (MRI) Evidence of Tissue Ablation/Edema at Targeted Lumbar Medial Branches|Documentation of Magnetic Resonance Imaging (MRI) evidence of tissue ablation/edema at targeted lumbar medial branches as they course around the superior articular process and transverse process juncture of the vertebrae|7 days|Patients undergoing lumbar medial branch radiofrequency ablation using the Nimbus MEE Probe who undergo MRI and EMG validation testing of efficacy of intended lesion production. EMG of lumbar multifidi for medial branch lesion documentation was carried out and percent of successful lesions recorded and analyzed.||percentage of participants|||Number
647625|NCT02120443|Secondary|Significant Skin Irritation or Disruption to Skin Integrity|The number of IV sites with significant skin irritation or disruption to skin integrity assessed at the end of the study. The Clopper-Pearson method was used for estimating the binomial proportion confidence interval.|24 hours|Three participants were excluded for significant protocol deviations.||IV sites||95% Confidence Interval|Number
647626|NCT02120443|Secondary|Normal Tissue Yellow Notification Rate|The ivWatch Model 400 issues yellow notifications to communicate the need for a clinician to check an IV site. A yellow notification suggests an increased likelihood that an IV infiltration may be occurring, although at a lower likelihood relative to a red notification. This measure describes the average number of yellow notifications issued by the ivWatch device in a given day when monitoring normal, non-infiltrated tissues. The 95% confidence interval for the yellow notification rate was calculated using the Clopper-Pearson method.|24 hours|Three participants were excluded due to significant protocol deviations.||yellow notifications per day||95% Confidence Interval|Mean
647641|NCT02120300|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 24 weeks|Safety Analysis Set||percentage of participants|||Number
650406|NCT02056834|Primary|Articular Subsidence|Evidence of articular subsidence (collapse of surface pertaining to the joint) of ≥2 mm was assessed by the investigators|12 months|||participants|||Number
647627|NCT02120443|Primary|Normal Tissue Red Notification Rate|The ivWatch Model 400 issues red notifications to communicate the need for a clinician to check an IV site. A red notification suggests an increased likelihood that an IV infiltration may be occurring, with a greater likelihood relative to a yellow notification. This measure describes the average number of red notifications issued by the ivWatch device in a given day when monitoring normal, non-infiltrated tissues. The 95% confidence interval for the red notification rate was calculated using the Clopper-Pearson method.|24 hours|Three subjects were excluded from analysis due to significant protocol deviations.||red notifications per day||95% Confidence Interval|Mean
647628|NCT02120417|Primary|Percentage of Participants Achieving Overall Survival|Overall survival was assessed by the time to death or censoring up until 08Feb2016. Participants with no observed death were treated as right-censored at their last date known to be alive. The survival time was analyzed using the Kaplan-Meier method.|Randomization until death due to any cause at month 3, 6, 9, 12 and 15 or the data cutoff 08FEB2016.|The Intent-to-Treat (ITT) population consisted of all participants randomized to the study.||percentage of participants||95% Confidence Interval|Number
647629|NCT02120417|Secondary|Percentage of Participants Achieving Clinical Benefit Rate|Clinical benefit rate was defined as a complete response, partial response, or stable disease, determined by investigator assessment of objective radiographic disease assessments per RECIST (v1.1) that lasted for ≥ 6 months. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI) : Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions with no worsening of non-target lesions and no new lesions; Overall Response (OR) = CR + PR.|Randomization through end of study up to 19 months or the data cutoff 08FEB2016.|The Intent-to-Treat (ITT) population consisted of all participants randomized to the study.||percentage of participants|||Number
647630|NCT02120417|Secondary|Duration of Response (DOR)|The DOR was defined as the difference (in number of months) between the end of response and the start of response for participants who had at least 1 response measurement. The start of a response was the first visit where the participant achieved a partial response or better based on RECIST (v1.1) criteria. The end of response was the earlier of death or progressive disease based on RECIST (v1.1) criteria. The date of progressive disease was the date on which progression was first recorded. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI) : Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions with no worsening of non-target lesions and no new lesions; Overall Response (OR) = CR + PR.|Randomization through end of study up to 19 months or the data cutoff 08FEB2016.|The Intent-to-Treat (ITT) population consisted of all participants randomized to the study.||months||80% Confidence Interval|Median
647631|NCT02120417|Secondary|Percentage of Participants Achieving Objective Response Rate|Objective response rate determined by radiographic disease assessments per RECIST (v1.1), by investigator assessment and was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) by Response Evaluation Criteria in Solid Tumours (RECIST) at any post baseline visit. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI) : Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions with no worsening of non-target lesions and no new lesions; Overall Response (OR) = CR + PR.|Randomization through end of study up to 19 months or the data cutoff 08FEB2016.|The Intent-to-Treat (ITT) population consisted of all participants randomized to the study.||percentage of participants|||Number
647632|NCT02120417|Secondary|Progression-free Survival (PFS)|Progression-free survival was defined as the time from the randomization date to the earliest date of disease progression, as measured by investigator assessment of objective radiographic disease assessments per RECIST (v1.1), or death from any cause if earlier. Progression-free survival time distribution and median survival for each treatment group were analyzed using the Kaplan-Meier method.|Randomization to disease progression, or death due to any cause if sooner up to 19 months or the data cutoff 08FEB2016.|The Intent-to-Treat (ITT) population consisted of all participants randomized to the study.||months||95% Confidence Interval|Median
647633|NCT02120417|Primary|Median Survival|Survival was assessed by the time to death or censoring up until 08Feb2016. Participants with no observed death were treated as right-censored at their last date known to be alive. The survival time was analyzed using the Kaplan-Meier method.|Randomization until death due to any cause up to 19 months or the data cutoff 08FEB2016.|The Intent-to-Treat (ITT) population consisted of all participants randomized to the study.||months||95% Confidence Interval|Median
647634|NCT02120417|Primary|Overall Survival (OS)|Overall survival is reported here by the number of days from randomization to death until the data cutoff for the final analysis. The hazard ratio (80% CI) for ruxolitinib versus placebo was estimated using a Cox regression model stratified by hormone-receptor status.|Randomization until death due to any cause up to 19 months or the data cutoff 08FEB2016.|The Intent-to-Treat (ITT) population consisted of all participants randomized to the study.||Participants|||Count of Participants
647635|NCT02120300|Secondary|Change From Baseline in Serum Creatinine at the End of Treatment and at Posttreatment Week 12 (HIV-1/HCV Co-infected Participants Only)||Baseline; Weeks 12, 24, and Posttreatment Week 12|Participants coinfected with HIV-1 and HCV in the Safety Analysis Set with available data were analyzed.||mg/dL||Standard Deviation|Mean
647636|NCT02120300|Secondary|Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL at Weeks 4, 8, 12, 16, 20, and 24 (HIV-1/HCV Co-infected Participants Only)||Weeks 4, 8, 12, 16, 20, and 24|Only the participants coinfected with HIV-1 and HCV in the Safety Analysis Set with available data were analyzed.||percentage of participants|||Number
647637|NCT02120300|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as:
On-treatment virologic failure:
Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)
Virologic relapse:
Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 24|Full Analysis Set||percentage of participants|||Number
647642|NCT02120300|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants enrolled into the study and received at least 1 dose of study drug.||percentage of participants||95% Confidence Interval|Number
647643|NCT02120027|Secondary|Sustained Analysis of Response for Abdominal Pain AND Stool Consistency Over First 24-week Double-blind Treatment Period|Weekly response for abdominal pain intensity AND stool consistency over the first 24 weeks of treatment in at least 50% of the weeks of treatment (12 out of 24 weeks) with at least 2 weeks of response in the last 4 weeks of treatment (week 21 to 24). The patient will be considered a weekly responder as defined for the primary endpoint.|24 weeks|Modified ITT (mITT) Population: all patients included in the ITT population excluding patients from site 00179 (N=48), where a potential serious breach of Good Clinical Practice was reported, and site 00186 (N=34), where disqualification proceedings against the Investigator were initiated by the US Food and Drug Administration.||Participants|||Count of Participants
647644|NCT02120027|Secondary|Weekly Response for Relief of Overall IBS Signs and Symptoms Over the First 24 Weeks of Treatment in at Least 50% of the Weeks (12 Out of 24)|"The patient was considered a weekly responder if she has an IBS degree-of-relief equal to completely relieved/improved or considerably relieved/improved.
Weekly e-diary assessment of IBS degree-of-relief of overall on signs or symptoms over the last 7 days was collected using a balanced 7-point Likert scale with 1= Completely relieved/improved, 2= Considerably relieved/improved, 3=Somewhat relieved/improved, 4= Unchanged, 5= Somewhat worse, 6=Considerably worse, 7= As bad as I can imagine."|24 weeks|Modified ITT (mITT) Population: all patients included in the ITT population excluding patients from site 00179 (N=48), where a potential serious breach of Good Clinical Practice was reported, and site 00186 (N=34), where disqualification proceedings against the Investigator were initiated by the US Food and Drug Administration.||Participants|||Count of Participants
647645|NCT02120027|Secondary|Weekly Response for Stool Consistency Over the First 24 Weeks of Treatment in at Least 50% of the Weeks of Treatment (12 Out of 24 Weeks).|"The patient was considered a weekly stool consistency responder if she met the following criterion:
Decrease of at least 50% in the number of days per week with at least one stool that has a consistency of Type 6 or 7 compared with baseline."|24 weeks|Modified ITT (mITT) Population: all patients included in the ITT population excluding patients from site 00179 (N=48), where a potential serious breach of Good Clinical Practice was reported, and site 00186 (N=34), where disqualification proceedings against the Investigator were initiated by the US Food and Drug Administration.||Participants|||Count of Participants
647646|NCT02120027|Secondary|Weekly Response for Abdominal Pain Intensity Over the First 24 Weeks of Treatment in at Least 50% of the Weeks of Treatment (12 Out of 24 Weeks).|"The patient will be considered a weekly abdominal pain responder if she meets the following criterion:
Decrease in weekly average of worst abdominal pain score in the past 24 hours of at least 30% compared with baseline."|24 weeks|Modified ITT (mITT) Population: all patients included in the ITT population excluding patients from site 00179 (N=48), where a potential serious breach of Good Clinical Practice was reported, and site 00186 (N=34), where disqualification proceedings against the Investigator were initiated by the US Food and Drug Administration.||Participants|||Count of Participants
647647|NCT02120027|Primary|Weekly Response for Abdominal Pain Intensity AND Stool Consistency Over the First 24 Weeks of Treatment in at Least 50% of the Weeks of Treatment (12 Out of 24 Weeks).|"The patient will be considered a weekly responder if she meets both of the following criteria in the same week:
Abdominal pain response: decrease in weekly average of worst abdominal pain score in the past 24 hours of at least 30% compared with baseline (patients reported their worst abdominal pain on a 0 to 10 NRS scale, where 0 corresponds to no pain and 10 corresponds to worst possible pain);
Stool consistency response: decrease of at least 50% in the number of days per week with at least one stool that has a consistency of Type 6 or 7 compared with baseline (patients reported their stool consistency response using the Bristol Stool Chart score based on a 1 to 7 NRS scale where 1 corresponds to hard stool and 7 corresponds to watery diarrhoea)."|24 weeks|Modified ITT (mITT) Population: all patients included in the ITT population excluding patients from site 00179 (N=48), where a potential serious breach of Good Clinical Practice was reported, and site 00186 (N=34), where disqualification proceedings against the Investigator were initiated by the US Food and Drug Administration.||Participants|||Count of Participants
647648|NCT02120001|Secondary|Microbiological Colonization of Distal Airways|Investigators will collect data about distal airways samples performed for clinical reasons during the study period and, in addition, investigators will collect a specimen from the distal airways immediately before extubation.|At extubation (An expected average of 7 days)|||Log colony form unit (CFU)/ mL||Standard Deviation|Mean
647649|NCT02120001|Primary|Endotracheal Tube Colonization|Discarded ETTs will be collected after extubation and sent for quantitative and qualitative microbiological analysis after silver ion inactivation. Qualitative analysis was based on confocal microscopy, we described visually the distribution of microbial colonization. However, we did not report numerical value because the confounding factors (i.e., number and length of devices).|At extubation (an expected average of 7 days)|||Log colony form unit (CFU)/ mL||Standard Deviation|Mean
647650|NCT02119676|Secondary|Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)|TEAEs were defined as any adverse event (AE) during the study that began or worsened on or after the date of first dose of investigational product.|Baseline through approximately 30 days post treatment discontinuation;up to 16 months or data cut-off 27JAN 2016 for Substudy 1 and up to the data cut-off of 11FEB2016 for Substudy 2.|Safety Population consists of all enrolled participants that received at least one dose of study drug.||percentage of participants|||Number
647651|NCT02119676|Secondary|Percentage of Participants Achieving Disease Control|Disease control as measured by the percentage of participants whose best response was complete response (CR), partial response (PR), or stable disease (SD) per RECIST v.1.1.|Baseline through end of study; up to 16 months or data cut-off 11 FEB 2016.|Intent-to-treat (ITT) population included all subjects randomized in Substudy 1 and Substudy 2 of the study.||percentage of participants||95% Confidence Interval|Number
647766|NCT02117687|Secondary|Subject Assessment of Dry Eye Symptoms on a 5-Point Scale|Subjects assess dry eye symptoms on a 5-point scale (none, mild, moderate, severe, very severe).|Baseline, Day 35, Month 3|Per Protocol: all randomized subjects who received at least one dose of the study product, had at least one follow-up visit, and who did not adhere to a pre-defined list of protocol violation criteria||Subjects|||Number
647652|NCT02119676|Secondary|Duration of Response|Duration of response is defined as the time from response (CR/PR) until the earliest date of disease progression determined by investigator assessment of objective radiographic disease assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause.|Baseline through end of study; up to 16 months or data cut-off 11 FEB 2016.|No data displayed because outcome measure has not been analyzed. Duration of response analyses was not done since there were no responders in Substudy 1 and very few responders in Substudy 2 at data cutoff (27JAN2016 for Substudy 1 and 11Feb2016 for Substudy 2). Duration of response analysis was not done in both substudies.|||||
647653|NCT02119676|Secondary|Overall Response Rate (ORR)|Response defined per Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)=disappearance of all target and non-target lesions without new lesion; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions, non-target lesion not progressed, and no new lesion; Progressive Disease=20% increase in sum of longest diameter of target lesions, or non-target lesion progression, or identification of new lesion; Stable Disease=small changes that do not meet above criteria. ORR was defined as the proportion of participants who achieved a best response of either CR or PR. ORR=number of participants with CR or PR/number of participants randomized.|Baseline through end of study; up to 16 months or data cut-off 11 FEB 2016.|Intent-to-treat (ITT) population included all subjects randomized in Substudy 1 and Substudy 2 of the study.||percentage of responders||95% Confidence Interval|Number
647654|NCT02119676|Secondary|Progression Free Survival (PFS)|Progressive Disease (PD) is defined using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 at least a 20% increase in the sum of the Longest Diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, unequivocal progression of non-target lesions, or the appearance of new lesions.|Baseline through disease progression, or death due to any cause if sooner; up to 16 months or data cut-off 11 FEB 2016.|Intent-to-treat (ITT) population included all subjects randomized in Substudy 1 and Substudy 2 of the study.||months||95% Confidence Interval|Median
647655|NCT02119676|Primary|Overall Survival (OS)|Overall survival is defined as the time from randomization to death due to any cause. Participants without death observed at the time of the analysis will be censored at last date known to be alive. The median overall survival time was estimated using the Kaplan-Meier method. Overall survival was compared between treatment groups using log-rank test.|Baseline until death due to any cause; up to 16 months or data cut-off 11 FEB 2016.|Intent-to-treat (ITT) population included all subjects randomized in Substudy 1 and Substudy 2 of the study.||months||95% Confidence Interval|Median
647656|NCT02119663|Secondary|Participants With Treatment-Emergent Adverse Events (TEAEs)|A treatment-emergent AE was defined as an event occurring after exposure to at least 1 dose of study drug (ruxolitinib or placebo). A treatment-related AE was defined as an event with a definite, probable, or possible causality to study medication. A serious AE is an event resulting in death, hospitalization, persistent or significant disability/incapacity, or is life threatening, a congenital anomaly/birth defect or requires medical or surgical intervention to prevent 1 of the outcomes above. The intensity of an AE was graded according to the National Cancer Institute common terminology criteria for adverse events (NCI-CTCAE) version 4.03: Grade 1 (Mild); Grade 2 (Moderate); Grade 3 (Severe); Grade 4 (life-threatening).|Baseline through approximately 30 days post treatment discontinuation; up to 6-months or to the data cutoff 11FEB2016.|The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).||Participants|||Count of Participants
647657|NCT02119663|Secondary|Duration of Response|Duration of overall response was defined as the time in months from Complete Response (CR) or Partial Response (PR) by Response Evaluation Criteria in Solid Tumours (RECIST v1.1) until the first date Progressive Disease (PD) was objectively documented or until the date of death. Per RECIST for target lesions and assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI): Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions with no worsening of non-target lesions and no new lesions; Overall Response (OR) = CR + PR.|Baseline through end of study; up to 6-months or to the data cutoff 11FEB2016.|The intent-to-treat (ITT) population consisted of all participants randomized to the study.||days||95% Confidence Interval|Median
647658|NCT02119663|Secondary|Objective Response Rate (ORR)|Objective response rate determined by radiographic disease assessments per Response Evaluation Criteria in Solid Tumours RECIST (v1.1), by investigator assessment and was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) by RECIST at any post baseline visit. Per RECIST for target lesions and assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI): Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions with no worsening of non-target lesions and no new lesions; Overall Response (OR) = CR + PR.|Baseline through end of study; up to 6-months or to the data cutoff 11FEB2016.|The intent-to-treat (ITT) population consisted of all participants randomized to the study.||percentage of participants|||Number
647659|NCT02119663|Secondary|Percentage of Participants Achieving Progression Free Survival (PFS)|PFS is defined as the time from randomization until the earliest date of disease progression determined by investigator assessment of objective radiographic disease assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause if sooner. Progressive Disease (PD) is defined using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, unequivocal progression of non-target lesions, or the appearance of new lesions.|Randomization to disease progression, or death due to any cause if sooner; up to 6-months or to the data cutoff 11FEB2016.|The intent-to-treat (ITT) population consisted of all participants randomized to the study.||percentage of participants||95% Confidence Interval|Median
647670|NCT02119325|Secondary|Tmax for Insulin in IFG Status Participants|To evaluate the effect of fibre rich health food drink on Tmax for insulin in healthy overweight adults with IFG|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.||minutes||Standard Deviation|Mean
647660|NCT02119663|Secondary|Progression Free Survival (PFS)|PFS is defined as the time from randomization until the earliest date of disease progression determined by investigator assessment of objective radiographic disease assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause if sooner. Progressive Disease (PD) is defined using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, unequivocal progression of non-target lesions, or the appearance of new lesions.|Randomization to disease progression, or death due to any cause if sooner; up to 6-months or to the data cutoff 11FEB2016.|The intent-to-treat (ITT) population consisted of all participants randomized to the study.||days||95% Confidence Interval|Median
647661|NCT02119663|Primary|Overall Survival (OS)|Overall survival is reported here based on the number of deaths from randomization until the data cut-off.|Randomization until death due to any cause up to 6-months or to the data cutoff 11FEB2016.|The intent-to-treat (ITT) population consisted of all participants randomized to the study.||Participants|||Count of Participants
647667|NCT02119325|Secondary|Tmax for Insulin in Overweight Healthy Participants|To evaluate the effect of fibre rich health food drink on Tmax for insulin in healthy overweight adults|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.||minutes||Standard Deviation|Mean
647668|NCT02119325|Secondary|AUC for Insulin in Overweight Healthy Participants|To evaluate the effect of fibre rich health food drink on AUC for insulin in healthy overweight adults|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.||µIU*min/mL||Standard Deviation|Mean
647669|NCT02119325|Secondary|Cmax for Insulin in Overweight Healthy Participants|To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for insulin in healthy overweight adults|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.||µIU/mL||Standard Deviation|Mean
647671|NCT02119325|Secondary|AUC for Insulin in IFG Status Participants|To evaluate the effect of fibre rich health food drink on AUC for insulin in healthy overweight adults with IFG|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.||µIU*min/mL||Standard Deviation|Mean
647672|NCT02119325|Secondary|Cmax for Insulin in IFG Status Participants|To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for insulin in healthy overweight adults with IFG|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.||µIU/mL||Standard Deviation|Mean
647673|NCT02119325|Secondary|Tmax for RLP Cholesterol in Overweight Healthy Participants|To evaluate the effect of fibre rich health food drink on Tmax of RLP Cholesterol in healthy overweight adults|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.||minutes||Standard Deviation|Mean
647674|NCT02119325|Secondary|AUC for RLP Cholesterol in Overweight Healthy Participants|To evaluate the effect of fibre rich health food drink on AUC for RLP Cholesterol in healthy overweight adults|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.||mmole*min/L||Standard Deviation|Mean
647675|NCT02119325|Secondary|Cmax for RLP Cholesterol in Overweight Healthy Participants|To evaluate the effect of fibre rich health food drink on post prandial RLP Cholesterol peak (Cmax) in healthy overweight adults|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.||mmole/L||Standard Deviation|Mean
647676|NCT02119325|Secondary|Tmax for RLP Cholesterol in IFG Status Participants|To evaluate the effect of fibre rich health food drink on Tmax for RLP Cholesterol in healthy overweight adults with IFG|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.||minutes||Standard Deviation|Mean
647677|NCT02119325|Secondary|AUC for RLP Cholesterol in IFG Status Participants|To evaluate the effect of fibre rich health food drink on AUC for RLP Cholesterol in healthy overweight adults with IFG|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.||mmole*min/L||Standard Deviation|Mean
647678|NCT02119325|Secondary|Cmax for RLP Cholesterol in IFG Status Participants|To evaluate the effect of fibre rich health food drink on post prandial Remnant Lipoprotein Cholesterol (RLP Cholesterol) peak (Cmax) in healthy overweight adults with IFG|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.||mmole/L||Standard Deviation|Mean
647679|NCT02119325|Secondary|Tmax for Triglycerides in Overweight Healthy Participants|To evaluate the effect of fibre rich health food drink on Tmax of triglycerides in healthy overweight adults|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.||minutes||Standard Deviation|Mean
647680|NCT02119325|Secondary|AUC for Triglycerides in Overweight Healthy Participants|To evaluate the effect of fibre rich health food drink on area under the curve (AUC) for triglycerides in healthy overweight adults|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.||mg*min/dL||Standard Deviation|Mean
647681|NCT02119325|Secondary|Cmax for Triglyceride in Overweight Healthy Participants|To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for triglyceride in healthy overweight adults|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.||mg/dL||Standard Deviation|Mean
647748|NCT02118597|Secondary|Number of Participants With Treatment Discontinuation Due to Futility|Treatment discontinuation due to futility is defined as HCV RNA drop <3 log10 at Week 8, HCV RNA >/=100 IU/mL at Week 12, or HCV RNA >/=15 IU/mL at Week 24.|Up to Week 48|ITT population included all enrolled participants.||participants|||Number
647682|NCT02119325|Secondary|Tmax for Glucose in Overweight Healthy Participants|To evaluate the effect of fibre rich health food drink on the time when maximum post prandial concentration is reached (Tmax) of blood glucose in healthy overweight adults|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.||minutes||Standard Deviation|Mean
647683|NCT02119325|Secondary|AUC for Glucose in Overweight Healthy Participants|To evaluate the effect of fibre rich health food drink on area under the curve (AUC) for glucose in healthy overweight adults|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.||mg*min/dL||Standard Deviation|Mean
647684|NCT02119325|Secondary|Cmax for Glucose in Overweight Healthy Participants|To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for glucose in healthy overweight adults|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.||mg/dL||Standard Deviation|Mean
647685|NCT02119325|Primary|Cmax for Triglyceride in IFG Status Participants|To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for triglyceride in healthy overweight adults with IFG|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.||mg/dL||Standard Deviation|Mean
647686|NCT02119325|Primary|Cmax for Glucose in IFG Status Participants|To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for glucose in healthy overweight adults with impaired fasting glucose (IFG)|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.||mg/dL||Standard Deviation|Mean
647687|NCT02119299|Secondary|Device Compliance|Device compliance is calculated as 100*(# Device Uses Since Visit 5)/(# eating episodes since Visit 5).|Week 16|||% of eating episodes with device use||Standard Deviation|Mean
647688|NCT02119299|Secondary|Percentage Total Body Loss and Treatment Compliance Correlation|The measured relationship between SMART device usage and total weight loss.|16 weeks|Per Protocol Population||Pearson correlation|||Number
647689|NCT02119299|Secondary|Proportion of Subjects Achieving ≥12% EWL||16 weeks|Per Protocol Population||Participants|||Count of Participants
647690|NCT02119299|Secondary|Proportion of Subjects Achieving ≥4% Weight Loss||16 weeks|Per Protocol Population||Participants|||Count of Participants
647691|NCT02119299|Secondary|Mean Absolute Weight Loss (kg)||16 weeks|Per Protocol Population||Body weight (kg)||Standard Deviation|Mean
647692|NCT02119299|Secondary|Mean Percentage Excess Weight Loss (EWL)||16 weeks|Per Protocol Population||percentage of excess weight loss||Standard Deviation|Mean
647693|NCT02119299|Primary|Mean %Total Body Weight Loss (TBL) at 16 Weeks Compared to Week 0||16 weeks|Per Protocol population||% TBL||Standard Deviation|Mean
647694|NCT02119299|Primary|Proportion of Subjects Achieving ≥5% Weight Loss at 16 Weeks Compared to Week 0||16 weeks|Per Protocol Population||Participants|||Count of Participants
647695|NCT02119286|Secondary|Change From Baseline in Weighted Mean (WM), 0-6 Hour FEV1 Obtained Post-dose at Day 84|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The 0-6 hour weighted mean was derived by calculating the area under the FEV1/time curve over the nominal time points of 0 hour (trough value), 15 and 30 min, 1, 3 and 6 hours, using the trapezoidal rule, and then dividing by the actual time between dosing and the 6 hour assessment. Analysis was performed using MMRM with covariates of treatment, Baseline FEV1 (mean of the two assessments made 30 minutes and 5 minutes pre-dose on Day 1), smoking status, Day, and Day by Baseline and Day by treatment interactions. Baseline FEV1 is the mean of the two assessments made at 30 and 5 min pre-dose on Day 1. The change from baseline value is the difference between the on-treatment value and the baseline value.|Day 84|ITT Population. Number of participants presented represent those with data available at the time point being presented; however, all participants in the ITT population without missing covariate information and with at least one post baseline measurement are included in the analysis.||Liters||Standard Error|Least Squares Mean
647696|NCT02119286|Primary|Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) at Day 85|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Day 85 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Day 84. Analysis was performed using a mixed model repeated measures (MMRM) with covariates of treatment, Baseline FEV1, smoking status, Day, treatment, Day by baseline interaction and Day by treatment interaction, Day being nominal. Baseline FEV1 is the mean of the two assessments made at 30 and 5 minutes (min) pre-dose on Day 1. The change from baseline value is the difference between the on-treatment value and the baseline value.|Day 85|ITT Population: all pars. randomized to treatment who received ≥ 1 dose of randomized study medication in the Treatment Period. Number of pars. presented represent those with data available at given time point; however, all pars. in the ITT population without missing covariate information, with ≥ 1 post BL measurement are included in the analysis.||Liters||Standard Error|Least Squares Mean
647749|NCT02118597|Secondary|Number of Participants With Virological Relapse|Virological response is defined as HCV RNA >/=15 IU/mL during the treatment free follow-up period in participants with virological response at the end of treatment.|Week 49 up to Week 72|ITT population included all enrolled participants.||participants|||Number
647697|NCT02119104|Primary|Number of Participants With Adverse Reactions|An adverse reaction (vaccine-related adverse event) was any untoward medical occurrence which was considered to be related to Prevenar 13 in a participant who received Prevenar 13.|The entire observation period was from Day 1 of the 1st vaccination through Day 28 of the 4th vaccination.|The safety analysis population comprised of participants who had received Prevenar 13 at least once and provided the safety data and who did not meet the exclusion criteria for the safety analysis.||Participants|||Number
647698|NCT02118961|Secondary|Percentage of Participants With Adverse Events||28-42 days following vaccination|||percentage of participants|||Number
647699|NCT02118961|Secondary|Geometric Mean Titer Ratios of Anti-PT and Anti-FHA Antibodies|Ratios were calculated as 28-42 days after vaccination titers over pre vaccination titers|pre vaccination and 28-42 days after vaccination|The Outcome Measure was only pre-specified for the BK1301 Arm/Group.||titer ratio||95% Confidence Interval|Geometric Mean
647700|NCT02118961|Secondary|Geometric Mean Titer Ratios of Anti-D and Anti-T Antibodies|Ratios were calculated as 28-42 days after vaccination titers over pre vaccination titers|pre vaccination and 28-42 days after vaccination|||titer ratio||95% Confidence Interval|Geometric Mean
647701|NCT02118961|Secondary|Geometric Mean Titers (GMTs) of Anti-PT and Anti-FHA Antibodies||28-42 days after vaccination|The Outcome Measure was only pre-specified for the BK1301 Arm/Group.||EU/mL||95% Confidence Interval|Geometric Mean
647702|NCT02118961|Secondary|Geometric Mean Titers (GMTs) of Anti-D and Anti-T Antibodies||28-42 days after vaccination|||IU/mL||95% Confidence Interval|Geometric Mean
647703|NCT02118961|Secondary|Percentage of Participants With Anti-PT and Anti-FHA Antibody Titers Above Protocol Defined Cut-off Values|Protocol defined cut-off values were 10 EU/mL.|28-42 days after vaccination|The Outcome Measure was only pre-specified for the BK1301 Arm/Group.||percentage of Participants||95% Confidence Interval|Number
647704|NCT02118961|Secondary|Percentage of Participants With Anti-D and Anti-T Antibody Titers Above Protocol Defined Cut-off Values|Protocol defined cut-off values were 0.1 IU/mL for anti-D and 0.01 IU/mL for anti-T.|28-42 days after vaccination|||percentage of Participants||95% Confidence Interval|Number
647705|NCT02118961|Primary|Percentage of Participants With Booster Responses for Anti-pertussis Toxoid (Anti-PT) and Anti-Filamentous Hemagglutinin (Anti-FHA) Antibodies|Booster response was defined as post titer ≥ 20 EU/mL and post/pre titer ≥ 4 increase in a subject with pre titer < 20 EU/mL, or post/pre titer ≥ 2 increase in a subject with pre titer ≥ 20 EU/mL.|pre-vaccination and 28-42 days after vaccination|The Outcome Measure was only pre-specified for the BK1301 Arm/Group.||percentage of Participants||95% Confidence Interval|Number
647706|NCT02118961|Primary|Percentage of Participants With Booster Responses for Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibodies|Booster response was defined as post titer ≥ 0.4 IU/mL and post/pre titer ≥ 4 increase.|pre-vaccination and 28-42 days after vaccination|||percentage of Participants||95% Confidence Interval|Number
647707|NCT02118896|Post-Hoc|Efficacy Failure|Efficacy failure was defined as BCAR, graft loss, death, or an unknown outcome at the end of the study period. Start, event and censor times for the Kaplan-Meier analyses of efficacy failure were (Event time: onset of first episode of BCAR, graft loss, or death after study start, Censor Time: day of withdrawal (for participants prematurely withdrawn from the study), and day of last visit (for participants completing the study). No Kaplan-Meier estimates for PMR-EC-1210 due to the short subject participation period and the low number of subjects|Up to 5.75 years ((69 months (phase II) and 33 months (phase III)).|The study analysis population for this endpoint consisted of participants with efficacy failure.||participants with efficacy failure|||Number
647708|NCT02118896|Secondary|Number of Participants With Adverse Events|An AE was defined as any untoward medical occurrence in a participant administered study drug, which does not necessarily have a causal relationship with treatment. An AE was, therefore, any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use the study drug, whether or not related to the study drug. Causally-related is defined as a highly probably, probably, possible, not assessable or missing relationship as assessed by the investigator. An SAE was any untoward medical occurrence that at any dose: Resulted in death, was life threatening: did not refer to event which hypothetically might have caused death if more severe); resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect; required inpatient hospitalization/led to prolongation of hospitalization (treatment/observation/examination caused by AE was considered serious); other medically important events.|From first dose to duration of participation in the study (up to 6 years and 28 days after EOS).|FAS population.||participants with adverse events|||Number
647709|NCT02118896|Secondary|Time to First BCAR Episode|The time to first acute rejection episode was defined as the number of days from day 1 (defined as the day of study enrollment) to the first clinical, laboratory or histological signs that were considered to be related to the first acute rejection episode.|Up to 1344 days (3.75 years).|The study analysis population for this endpoint consisted of subjects with biopsy confimed acute rejection.||days||Standard Deviation|Mean
647710|NCT02118896|Secondary|Biopsy-confirmed Acute Rejection (BCAR) Episodes|FAS population. Evaluation of biopsy specimens performed by local histopathologist following “Histological Grading of Biopsies for Rejection” using grading relevant to type of organ allograft. Spontaneously resolving AR defined as episode not treated with new/increased corticosteroid medication, antibodies/any other medication and resolved irrespective of any MR4/MMF/azathioprine dose changes; corticosteroid sensitive AR was an episode which was treated with new/increased corticosteroid medication only and resolved, irrespective of any MR4, MMF or azathioprine dose changes; corticosteroid resistant AR was an episode which did not resolve following treatment with corticosteroids, if it was not treated with corticosteroids first but only with antibodies, it was included in this category; corticosteroid resistant AR episodes were further classified into episodes which resolved with further treatment and those which did not respond to further treatment/were ongoing at EOS/withdrawal.|Up to 6 years.|FAS population.||participants with with BCAR episodes|||Number
647750|NCT02118597|Secondary|Number of Participants With Virological Breakthrough|Virological breakthrough is defined as either HCV RNA >=15 IU/mL in participants with prior virological response or as an increase in HCV RNA >/=1 log10 above nadir.|Up to Week 48|ITT population included all enrolled participants.||participants|||Number
648547|NCT02100514|Secondary|Absolute Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12||Baseline, Week 12|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."||mg/dL||Standard Deviation|Mean
647711|NCT02118896|Primary|Graft Survival|Graft survival was analyzed using Kaplan-Meier Method procedures at 66 months (phase II) and 30 months (phase III). The two-sided 95% confidence intervals for the estimated rates of patients free from graft loss at EOS was calculated using Greenwood’s formula. Graft loss was defined as re-transplantation or death. For kidney transplantation graft loss was also defined as nephrectomy or return to long-term dialysis. The date of graft loss is the earliest date of either of these events. Start, event and censor times for the Kaplan-Meier analyses of graft survival were (Event time: day of death, Censor Time: day of last follow-up (for participants prematurely withdrawn from the study), and day of last visit (for participants completing the study) .|Up to 5.5 years ((66 months (phase II) and 30 months (phase III)).|Study analysis population for this primary endpoint consisted of the FAS.||survival probability||95% Confidence Interval|Number
647712|NCT02118896|Primary|Participant Survival|Participant survival was analyzed using Kaplan-Meier (KM) method procedures at 66 months (phase 2) and 24 months (phase III). The two-sided 95% confidence intervals (CI) for the estimated rates of patients alive at end of study (EOS) was calculated using Greenwood’s formula. Start, event and censor times for the Kaplan-Meier analyses of participant survival were (Event time: day of death, Censor Time: day of last follow-up (for participants prematurely withdrawn from the study), and day of last visit (for participants completing the study) .|Up to 5.5 years (66 months (phase II) and 24 months (phase III)).|The population for analysis was the Full Analysis Set (FAS) which included all subjects who received at least one dose of study drug, MR4, while participating in one of the phase II Pharmacokinetics (PK) or phase III studies and at least one dose of MR4 during this study.||survival probability||95% Confidence Interval|Number
647713|NCT02118831|Secondary|Change in Minimum Serum Levels of Free Vascular Endothelial Growth Factor From Baseline to Month 4 (One Month After Last Treatment)|Minimum serum levels of free vascular endothelial growth factor will be measured at baseline and at 4 months following treatment (one month after last treatment).|baseline and month 4|||pg/mL||95% Confidence Interval|Mean
647714|NCT02118831|Primary|Serum Pharmacokinetics Following Treatment From 1st and 3rd Doses|Maximum serum levels of ranibizumab, bevacizumab or aflibercept will be measured after the first and third injections, up to 28 days following each treatment.|Up to 4 months|||nM||Standard Deviation|Mean
647715|NCT02118792|Primary|Percentage of Participants With Local Tolerability Symptoms at Day 36|Local tolerability symptoms (burning/stinging) were assessed in participants at sites of study drug application. Symptoms were assessed on 4-point scale which ranges from 0 to 3, where 0 = none (no stinging/burning), 1 = mild (slight warm, tingling sensation); 2= moderate (definite warm; tingling/stinging sensation that is somewhat bothersome and severe); 3= severe (hot, tingling/stinging sensation that caused definite discomfort). Higher scores indicate high severity of symptoms. Percentage of participants with each level of local tolerability (none, mild, moderate, severe) symptoms were reported.|Day 36|"Safety population included all randomized participants who had at least 1 confirmed dose of study drug, and had at least 1 post-baseline assessment. Here, N signifies those participants who were evaluable for this outcome measure."||percentage of participants|||Number
647716|NCT02118792|Primary|Percentage of Participants With Local Tolerability Symptoms at Day 29|Local tolerability symptoms (burning/stinging) were assessed in participants at sites of study drug application. Symptoms were assessed on 4-point scale which ranges from 0 to 3, where 0 = none (no stinging/burning), 1 = mild (slight warm, tingling sensation); 2= moderate (definite warm; tingling/stinging sensation that is somewhat bothersome and severe); 3= severe (hot, tingling/stinging sensation that caused definite discomfort). Higher scores indicate high severity of symptoms. Percentage of participants with each level of local tolerability (none, mild, moderate, severe) symptoms were reported.|Day 29|"Safety population included all randomized participants who had at least 1 confirmed dose of study drug, and had at least 1 post-baseline assessment. Here, N signifies those participants who were evaluable for this outcome measure."||percentage of participants|||Number
647717|NCT02118792|Primary|Percentage of Participants With Local Tolerability Symptoms at Day 22|Local tolerability symptoms (burning/stinging) were assessed in participants at sites of study drug application. Symptoms were assessed on 4-point scale which ranges from 0 to 3, where 0 = none (no stinging/burning), 1 = mild (slight warm, tingling sensation); 2= moderate (definite warm; tingling/stinging sensation that is somewhat bothersome and severe); 3= severe (hot, tingling/stinging sensation that caused definite discomfort). Higher scores indicate high severity of symptoms. In this outcome, percentage of participants with each level of local tolerability (none, mild, moderate, severe) symptoms were reported.|Day 22|"Safety population included all randomized participants who had at least 1 confirmed dose of study drug, and had at least 1 post-baseline assessment. Here, number of participants analyzed N signifies those participants who were analyzed in this outcome measure."||percentage of participants|||Number
647718|NCT02118792|Primary|Percentage of Participants With Local Tolerability Symptoms at Day 15|Local tolerability symptoms (burning/stinging) were assessed in participants at sites of study drug application. Symptoms were assessed on 4-point scale ranging from 0 to 3, where 0= none (no stinging/burning), 1= mild (slight warm, tingling sensation); 2= moderate (definite warm; tingling/stinging sensation that is somewhat bothersome and severe); 3= severe (hot, tingling/stinging sensation that caused definite discomfort). Higher scores indicated more severe symptoms. Percentage of participants with each level of local tolerability (none, mild, moderate, severe) symptoms were reported.|Day 15|"Safety population included all randomized participants who had at least 1 confirmed dose of study drug, and had at least 1 post-baseline assessment. Here, N signifies those participants who were analyzed in this outcome measure."||percentage of participants|||Number
647719|NCT02118792|Primary|Percentage of Participants With Local Tolerability Symptoms at Day 8|Local tolerability symptoms (burning/stinging) were assessed in participants at sites of study drug application. Symptoms were assessed on 4-point scale ranging from 0 to 3, where 0= none (no stinging/burning), 1 = mild (slight warm, tingling sensation); 2= moderate (definite warm; tingling/stinging sensation that is somewhat bothersome and severe); 3= severe (hot, tingling/stinging sensation that caused definite discomfort). Higher scores indicated more severe symptoms. Percentage of participants with each level of local tolerability (none, mild, moderate, severe) symptoms were reported.|Day 8|"Safety population included all randomized participants who had at least 1 confirmed dose of study drug, and had at least 1 post-baseline assessment. Here, N signifies those participants who were evaluable for this outcome measure."||percentage of participants|||Number
650407|NCT02056834|Primary|Fracture Union|Fracture union (complete bone healing) was assessed by the investigators based on anteroposterior and lateral X-rays|12 months|||participants|||Number
647720|NCT02118792|Other Pre-specified|Change From Baseline in Dermatitis Family Impact Questionnaire (DFI) Score at Day 29|The DFI was a 10-item disease questionnaire that measures the impact of having a child with AD on family quality of life. It was completed by parent/legal guardian of the child (affected by AD), based on recall over the past week. Each question was scored on a 4-point scale ranging from 0 (good) to 3 (worst), where higher scores indicated worst quality of life of family. The DFI total score was the sum of individual scores of the 10 questions and ranges from 0 (good) to 30 (worst), where higher DFI scores indicated worst quality of life of family.|Baseline (Day 1), Day 29|ITT population included all participants who were randomized and received study drug. Here, ''N'' signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||units on a scale||Standard Deviation|Mean
647721|NCT02118792|Other Pre-specified|Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Day 29|The DLQI was a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.|Baseline (Day 1), Day 29|ITT population included all participants who were randomized and received study drug. Here, ''N'' signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||units on a scale||Standard Deviation|Mean
647722|NCT02118792|Other Pre-specified|Change From Baseline in Children’s Dermatology Life Quality Index (CDLQI) Score at Day 29|The CDLQI was a 10-item questionnaire that measures the impact of skin disease on children’s (aged 2-15 years) quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The CDLQI total score was the sum of individual scores of question 1-10 and ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the children’s life; 2-6 = small effect on the children’s life; 7-12 = moderate effect on the children’s life; 13-18 = very large effect on the children’s life; 19-30 = extremely large effect on the children’s life. Higher scores indicate more impact on quality of life of children.|Baseline (Day 1), Day 29|ITT population included all participants who were randomized and received study drug. Here, Number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||units on a scale||Standard Deviation|Mean
647723|NCT02118792|Other Pre-specified|Time to Improvement in Pruritus|Time to improvement in pruritus was defined as the time interval between the administration of first dose of study drug till the first documentation of improvement in pruritus. Improvement in pruritus was defined as achieving none (0) or mild (1) score with at least a 1- grade improvement from baseline. Severity of pruritus was assessed on 4-point numeric scale ranges from 0 to 3, where 0= none (no itching), 1= mild (occasional, slight itching/scratching), 2= moderate (constant or intermittent itching/scratching which is not disturbing sleep) and 3= severe (bothersome itching/scratching which is disturbing sleep). Higher scores indicated more severe condition. It was analyzed using Kaplan-Meier method.|Baseline (Day 1) up to Day 29|"ITT population included all participants who were randomized and received study drug. Here, N'' signifies those participants who were evaluable for this outcome measure."||days||95% Confidence Interval|Median
647724|NCT02118792|Secondary|Change From Baseline in Signs of Atopic Dermatitis at Day 29|Signs of AD included erythema, induration/papulation, exudation, excoriation and lichenification. Each sign was assessed on a 4- point scale ranges from 0 to 3, where 0= none, 1= mild, 2= moderate to 3= severe. Higher score indicates severe signs and symptoms of AD.|Baseline, Day 29|ITT population included all participants who were randomized and received study drug. Here, 'n' signifies those participants who were evaluable at specific time point for each arm.||units on a scale||Standard Deviation|Mean
647725|NCT02118792|Secondary|Time to Achieve Treatment Success Based on Investigator’s Static Global Assessment (ISGA)|Time to achieve treatment success based on ISGA was defined as the time interval between the administrations of first dose of study drug until first documentation of success in ISGA. Success in ISGA was defined as an ISGA score of clear (0) or almost clear (1) with at least 2-grade improvement from baseline. It was analyzed using Kaplan-Meier method.|Baseline up to Day 29|ITT population included all participants who were randomized and received study drug.||days||95% Confidence Interval|Median
647726|NCT02118792|Secondary|Percentage of Participants With an Investigator's Static Global Assessment (ISGA) Score of Clear (0) or Almost Clear (1) at Day 29|ISGA assessed the severity of AD (except scalp and venous access area) on a 5-point scale ranged from 0 (clear) to 4 (maximum severe), where higher scores indicate higher degree of AD. Grades for classification of severity: 0= clear (minor residual discoloration, no erythema or induration or papulation, no oozing or crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration or papulation and no oozing or crusting), 2= mild (faint pink erythema with mild induration or papulation and no oozing or crusting), 3= moderate (pink-red erythema with moderate induration or papulation with or without oozing or crusting) and 4= severe (deep or bright red erythema with severe induration or papulation and with oozing or crusting). Percentage of participants with an ISGA score of 0 or 1 were reported.|Day 29|ITT population included all participants who were randomized and received study drug.||percentage of participants|||Number
647727|NCT02118792|Primary|Percentage of Participants With Local Tolerability Symptoms at Baseline|Local tolerability symptoms (burning/stinging) were assessed in participants at sites of study drug application. Symptoms were assessed on 4-point scale ranging from 0 to 3, where 0 = none (no stinging/burning), 1 = mild (slight warm, tingling sensation); 2= moderate (definite warm; tingling/stinging sensation that is somewhat bothersome and severe); 3= severe (hot, tingling/stinging sensation that caused definite discomfort). Higher scores indicated more severe symptoms. Percentage of participants with each level of local tolerability (none, mild, moderate, severe) symptoms were reported.|Baseline (Day 1)|Safety population included all randomized participants who had at least 1 confirmed dose of study drug, and had at least 1 post-baseline assessment. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.||percentage of participants|||Number
647728|NCT02118792|Primary|Number of Participants With Clinically Significant Laboratory Values|Laboratory values included: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Albumin, Bilirubin, Blood Urea Nitrogen, Glucose, Hematocrit, Hemoglobin, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets, Basophils, Eosinophils, Erythrocytes, Potassium, Protein, Sodium. Clinically significant laboratory abnormalities were defined as abnormal laboratory test values that have clinical manifestations or require medical intervention, as per investigator’s discretion.|Baseline up to Day 36|Safety population included all randomized participants who had at least 1 confirmed dose of study drug, and had at least 1 post-baseline assessment.||participants|||Number
647729|NCT02118792|Primary|Number of Participants With Clinically Significant Change From Baseline in Vital Signs at Day 36|Following parameters were analyzed for examination of vital signs: systolic and diastolic blood pressure, pulse, respiratory rate and body temperature. Vital sign measurements were performed with the participant in the seated or supine position and after the participant had been calmly sitting or lying face up for a minimum of 5 minutes. Clinical significance of change from baseline value was determined by investigator.|Baseline (Day 1), Day 36|Safety population included all randomized participants who had at least 1 confirmed dose of study drug, and had at least 1 post-baseline assessment.||participants|||Number
647730|NCT02118792|Primary|Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings at Day 8|ECG parameters that were analyzed: PR interval, QRS interval, QT interval and corrected QT interval based on Fridericia’s formula (QTcF). Clinical significance of change from baseline in ECG findings was determined by investigator.|Baseline, Day 8|Safety population included all randomized participants who had at least 1 confirmed dose of study drug, and had at least 1 post-baseline assessment.||participants|||Number
647731|NCT02118792|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence attributed to a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; Initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug to the end of study, that were absent before treatment or that worsened relative to pre-treatment state.|AEs: Baseline (Day 1) up to Day 29, SAEs: Baseline (Day 1) up to Day 36|Safety population included all randomized participants who had at least 1 confirmed dose of study drug, and had at least 1 post-baseline assessment.||participants|||Number
647732|NCT02118792|Primary|Percentage of Participants Who Achieved Success in Investigator's Static Global Assessment (ISGA) Score at Day 29|ISGA assessed the severity of AD (except scalp) on a 5-point scale ranged from 0 (clear) to 4 (maximum severe), where higher scores indicate higher degree of AD. Grades for classification of severity: 0= clear (minor residual hypo/hyper pigmentation, no erythema or induration or papulation, no oozing or crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration or papulation and no oozing or crusting), 2= mild (faint pink erythema with mild induration or papulation and no oozing or crusting), 3= moderate (pink-red erythema with moderate induration or papulation with or without oozing or crusting) and 4= severe (deep or bright red erythema with severe induration or papulation and with oozing or crusting). Treatment success was defined as an ISGA score of Clear (0) or Almost Clear (1) with at least a 2-grade improvement from baseline.|Day 29|ITT population included all participants who were randomized and received study drug.||percentage of participants|||Number
647733|NCT02118766|Other Pre-specified|Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Day 29|The DLQI was a 10-item questionnaire that measures the impact of skin disease on participant’s quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant’s life; 2-6 = small effect on the participant’s life; 7-12 = moderate effect on the participant’s life; 13-18 = very large effect on the participant’s life; 19-30 = extremely large effect on the participant’s life. Higher scores indicate more impact on quality of life of participants.|Baseline, Day 29|Intent to treat population included all participants who were randomized and dispensed study drug. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||units on a scale||Standard Deviation|Mean
647734|NCT02118766|Other Pre-specified|Time to Improvement in Pruritus|Time to improvement in pruritus was defined as the time interval between the administration of first dose of study drug till the first documentation of improvement in pruritus. Improvement in pruritus was defined as achieving none (0) or mild (1) score with at least a 1- grade improvement from baseline. Severity of pruritus was assessed on 4-point numeric scale ranges from 0 to 3, where 0= none (no itching), 1= mild (occasional, slight itching/scratching), 2= moderate (constant or intermittent itching/scratching which is not disturbing sleep) and 3= severe (bothersome itching/scratching which is disturbing sleep). Higher scores indicated more severe condition. It was analyzed using Kaplan-Meier method.|Baseline up to Day 29|Intent to treat population included all participants who were randomized and dispensed study drug. Here, 'N' signifies those participants who were evaluable for this measure.||days||95% Confidence Interval|Median
647735|NCT02118766|Secondary|Change From Baseline in Signs of Atopic Dermatitis (AD) at Day 29|Signs of AD included erythema, induration/papulation, exudation, excoriation and lichenification. Each sign was assessed on a 4- point scale ranges from 0 to 3, where 0= none, 1= mild, 2= moderate to 3= severe. Higher score indicates severe signs and symptoms of AD.|Baseline, Day 29|Intent to treat population included all participants who were randomized and dispensed study drug. Here, Number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||units on a scale||Standard Deviation|Mean
647736|NCT02118766|Secondary|Time to Achieve Treatment Success Based on Investigator’s Static Global Assessment (ISGA)|Time to achieve treatment success based on ISGA was defined as the time interval between the administrations of first dose of study drug until first documentation of success in ISGA. Success in ISGA was defined as an ISGA score of clear (0) or almost clear (1) with at least 2-grade improvement from baseline. It was analyzed using Kaplan-Meier method.|Baseline (Day 1) up to Day 29|Intent to treat population included all randomized participants who received the study drug.||days||95% Confidence Interval|Median
647737|NCT02118766|Secondary|Percentage of Participants With an Investigator's Static Global Assessment (ISGA) Score of Clear (0) or Almost Clear (1) at Day 29|ISGA assessed the severity of AD (except scalp and venous access area) on a 5-point scale ranged from 0 (clear) to 4 (maximum severe), where higher scores indicate higher degree of AD. Grades for classification of severity: 0= clear (minor residual discoloration, no erythema or induration or papulation, no oozing or crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration or papulation and no oozing or crusting), 2= mild (faint pink erythema with mild induration or papulation and no oozing or crusting), 3= moderate (pink-red erythema with moderate induration or papulation with or without oozing or crusting) and 4= severe (deep or bright red erythema with severe induration or papulation and with oozing or crusting). Percentage of participants with an ISGA score of 0 or 1 were reported.|Day 29|Intent to treat population included all randomized participants who received the study drug.||percentage of participants|||Number
647738|NCT02118766|Primary|Number of Participants With Clinically Significant Change From Baseline in Laboratory Values at Day 29|Laboratory values included: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Albumin, Blood Urea Nitrogen, Creatinine, Hematocrit, Hemoglobin, Lymphocytes, Monocytes, Neutrophils, Platelets, Basophils, Eosinophils, Red blood cell count, White blood cell count, Total bilirubin and Glucose (nonfasting), Potassium, Total Protein, and Sodium. Clinical significance of change from baseline value was determined by investigator.|Baseline, Day 29|Safety population included all randomized participants who received at least 1 confirmed dose of study drug, and had at least 1 post-baseline assessment.||participants|||Number
647739|NCT02118766|Primary|Number of Participants With Clinically Significant Change From Baseline in Vital Signs at Day 29|Following parameters were analyzed for examination of vital signs: systolic and diastolic blood pressure, respiratory rate and body temperature. Vital sign measurements were performed with the participant in the seated or supine position. Clinical significance of change from baseline value was determined by investigator.|Baseline, Day 29|Safety population included all randomized participants who received at least 1 confirmed dose of study drug, and had at least 1 post-baseline assessment.||participants|||Number
647740|NCT02118766|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence attributed to a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; Initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to end of study that were absent before treatment or that worsened relative to pre-treatment state.|AEs: Baseline (Day 1) up to Day 29, SAEs: Baseline (Day 1) up to Day 36|Safety population included all randomized participants who received at least 1 confirmed dose of study drug, and had at least 1 post-baseline assessment.||participants|||Number
647741|NCT02118766|Primary|Percentage of Participants Who Achieved Treatment Success Based on Investigator’s Static Global Assessment (ISGA) at Day 29|ISGA assessed the severity of AD (except scalp and venous access area) on a 5-point scale ranged from 0 (clear) to 4 (maximum severe), where higher scores indicate higher degree of AD. Grades for classification of severity: 0= clear (minor residual hypo/hyper pigmentation, no erythema or induration or papulation, no oozing or crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration or papulation and no oozing or crusting), 2= mild (faint pink erythema with mild induration or papulation and no oozing or crusting), 3= moderate (pink-red erythema with moderate induration or papulation with or without oozing or crusting) and 4= severe (deep or bright red erythema with severe induration or papulation and with oozing or crusting). Treatment success was defined as an ISGA score of Clear (0) or Almost Clear (1) with at least a 2-grade improvement from baseline.|Day 29|Intent to treat population included all randomized participants who received the study drug.||percentage of participants|||Number
647742|NCT02118597|Secondary|Percentage of Participants With Positive Predictive Value of Previous Virological Response (Null-response, Partial Response, or Relapse)|Previous virological response was sub-categorized into the following categories: null-response, partial response, or relapse. Predictive value of these sub-categories for SVR rate were to be assessed.|Up to 72 weeks|Predictive values of previous virological response could not be analyzed as the SVR24 rate was based on one participant.|||||
647743|NCT02118597|Secondary|Predictive Value of HCV Disease Characteristics|HCV disease characteristics evaluated were HCV genotype (subtype), including HCV 1(a) and HCV 1(b). Predictive value of these disease characteristics for SVR rate were to be assessed.|Screening (before Week 1)|Predictive values of HCV disease characteristics could not be analyzed as the SVR24 rate was based on one participant.|||||
647744|NCT02118597|Secondary|Percentage of Participants With Positive Predictive Value of Liver Fibrosis|The following sub-categories of liver fibrosis were determined in this study: 1) no cirrhosis, 2) bridging fibrosis and 3) cirrhosis. Predictive value of these sub-categories of liver fibrosis for SVR rate was to be assessed.|Screening (before Week 1)|Predictive values of sub-categories of liver fibrosis could not be analyzed as the SVR24 rate was based on one participant.|||||
647745|NCT02118597|Secondary|Percentage of Participants With Positive Predictive Value of Participant Demographics for SVR Rate|Demographic characteristics recorded were age and gender. Predictive value of these characteristics for SVR rate was to be assessed.|Screening (before Week 1)|Predictive values of participant demographics could not be analyzed as the SVR24 rate was based on one participant.|||||
647746|NCT02118597|Secondary|Number of Participants With Adverse Events|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|Up to 72 weeks|ITT population included all enrolled participants.||participants|||Number
647747|NCT02118597|Secondary|Number of Participants With Treatment Discontinuation|Treatment discontinuation is reported by sub-categories of reasons for treatment discontinuation. Futility rule is defined as HCV RNA drop <3 log10 at Week 8, HCV RNA >/=100 IU/mL at Week 12, or HCV RNA >/=15 IU/mL at Week 24.|Up to Week 48|ITT population included all enrolled participants.||participants|||Number
647752|NCT02118597|Primary|Sustained Virological Response 24 (SVR24) Rate|The SVR 24 rate is defined as percentage of participants with Hepatitis C virus (HCV) Ribonucleic Acid (RNA) less than 15 international unit/milliliter (IU/mL) after the 24-weeks follow-up.|24 weeks after end of treatment (EOT) at Week 72|Due to the early termination of the study follow-up of the vast majority of the participants was not possible and data were not collected. Therefore, results for this outcome measure are based on one participant.||percentage of participants|||Number
647753|NCT02118441|Secondary|Complication Rate (Hematoma)|A hematoma was defined a collection of blood or formation of a bruise surrounding the site of radial artery catheterization|up to 5 minutes|||percentage of participants|||Number
647754|NCT02118441|Secondary|Number of Re-directions|A re-direct was defined as the needle being purposefully withdrawn at least 5 mm and re-directed (but not removed from the skin entirely).|up to 5 minutes|||number of re-directs||Inter-Quartile Range|Median
647755|NCT02118441|Secondary|Number of Attempts|An attempt was defined as a new purposeful penetration of the skin with the needle (i.e., following complete withdrawal of the needle from the skin).|up to 5 minutes|||number of attempts||Inter-Quartile Range|Median
647756|NCT02118441|Primary|Time to Successful Radial Arterial Catheterization|The time to successful radial arterial catheterization was defined as time zero to time of placement. Time zero for the DP group began when the anesthesiologist’s fingers were placed on the patient with the purpose of palpating the artery. Time zero for the US group began when the US transducer was first placed on the patient’s skin for the purpose of identifying the radial artery. Time to placement was defined as the interval from time zero until the time at which an arterial tracing was viewed on the monitor.|up to 5 minutes|||seconds||Inter-Quartile Range|Median
647757|NCT02117687|Secondary|Study Product Use|The number of times the study product is administered per day is recorded.|Day 8, Day 35, Month 3|Per Protocol: all randomized subjects who received at least one dose of the study product, had at least one follow-up visit, and who did not adhere to a pre-defined list of protocol violation criteria||Number of Times/Day||Standard Deviation|Mean
647758|NCT02117687|Secondary|Conjunctival Hyperaemia in the Study Eye|Macroscopic conjunctival hyperemia (eye redness) is graded in the study eye on a 5-point scale (none, trace, mild, moderate, severe).|Baseline, Day 35, Month 3|Per Protocol: all randomized subjects who received at least one dose of the study product, had at least one follow-up visit, and who did not adhere to a pre-defined list of protocol violation criteria||Subjects|||Number
647759|NCT02117687|Secondary|Change From Baseline in Conjunctival Staining in the Study Eye|The conjunctiva is the clear membrane covering the white surface of the eye. Staining of the conjunctiva followed ocular administration of lissamine green dye and was graded on a 6-point scale (0=no staining to 5=diffuse staining) in the temporal and nasal locations. A negative number change from baseline represents a decrease in corneal staining (improvement) and a positive number change from baseline represents an increase in corneal staining (worsening).|Baseline, Day 35, Month 3|Per Protocol: all randomized subjects who received at least one dose of the study product, had at least one follow-up visit, and who did not adhere to a pre-defined list of protocol violation criteria||Scores on a Scale||Standard Deviation|Mean
647760|NCT02117687|Secondary|Change From Baseline in Corneal Staining in the Study Eye|The cornea is the transparent front part of the eye which covers the iris and pupil. Staining of the cornea followed ocular administration of fluorescein dye and was graded on a 6-point scale (0=no staining to 5=diffuse staining). A negative number change from baseline represents a decrease in corneal staining (improvement) and a positive number change from baseline represents an increase in corneal staining (worsening).|Baseline, Day 35, Month 3|Per Protocol: all randomized subjects who received at least one dose of the study product, had at least one follow-up visit, and who did not adhere to a pre-defined list of protocol violation criteria||Scores on a Scale||Standard Deviation|Mean
647761|NCT02117687|Secondary|Work Productivity and Activity Impairment Questionnaire Score|The Work Productivity and Activity questionnaire assesses the effect of dry eye on the ability of subjects to work and perform regular activities on a scale from 0 to 10 during the past 7 days (0=dry eye had no effect on my work/daily activities to 10=dry eye completely prevented me from working/doing my daily activities). Since not all subjects were in full time employment during the study, not all items of the questionnaire were applicable to all subjects at each visit. Outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.|Baseline, Day 35, Month 3|Per Protocol: all randomized subjects who received at least one dose of the study product, had at least one follow-up visit, who did not adhere to a pre-defined list of protocol violation criteria, and who had data for this data point||Scores on a Scale||Standard Deviation|Mean
647762|NCT02117687|Secondary|Change From Baseline in Tear Break-up Time (TBUT) in the Study Eye|TBUT is the time required for dry spots to appear on the surface of the eye after blinking in the worse eye. The longer it takes, the more stable the tear film. A short TBUT is a sign of poor tear film. A positive number change from baseline indicates an increase in TBUT (improvement) and a negative number change from baseline indicates a decrease in TBUT (worsening).|Baseline, Day 35|Per Protocol: all randomized subjects who received at least one dose of the study product, had at least one follow-up visit, and who did not adhere to a pre-defined list of protocol violation criteria||Seconds||Standard Deviation|Mean
647763|NCT02117687|Secondary|Investigator Global Assessment of Treatment Efficacy on a 4-Point Scale|Investigators assess global treatment efficacy on a 4-point scale (very satisfactory, satisfactory, poor, very poor).|Day 35, Month 3|Per Protocol: all randomized subjects who received at least one dose of the study product, had at least one follow-up visit, and who did not adhere to a pre-defined list of protocol violation criteria||Subjects|||Number
647764|NCT02117687|Secondary|Subject Assessment of Treatment Acceptability on a 5-Point Scale|Subjects assess treatment acceptability (likability and comfort) on a 5-point scale (strongly agree, agree, neither agree nor disagree, disagree, strongly disagree).|Day 35|Per Protocol: all randomized subjects who received at least one dose of the study product, had at least one follow-up visit, and who did not adhere to a pre-defined list of protocol violation criteria||Subjects|||Number
647765|NCT02117687|Secondary|Subject Global Assessment of Treatment Efficacy on a 5-Point Scale|Subjects assess global treatment efficacy compared to baseline on a 5-point scale (much worse, worse, about the same, improved, much improved).|Baseline, Day 35, Month 3|Per Protocol: all randomized subjects who received at least one dose of the study product, had at least one follow-up visit, and who did not adhere to a pre-defined list of protocol violation criteria||Subjects|||Number
647767|NCT02117687|Secondary|Change From Baseline in the Schirmer Test in the Study Eye|The Schirmer's Test measures the rate of secretion of tears produced by the study eye over 5 minutes. The results indicate the presence of dry eye (Normal = greater than or equal to 10 millimeters (mm) of tears, Dry Eye = less than 10 mm of tears). The smaller the number, the more severe the dry eye. A positive number change from baseline indicates an increase in tears (improvement) and a negative number change from baseline indicates a decrease in tears (worsening).|Baseline, Day 35|Per Protocol: all randomized subjects who received at least one dose of the study product, had at least one follow-up visit, and who did not adhere to a pre-defined list of protocol violation criteria||Millimeters (mm)/5 Minutes||Standard Deviation|Mean
647768|NCT02117687|Secondary|Change From Baseline in Ocular Surface Disease Index© (OSDI) Score|The OSDI is a 12-question survey for patients to document their dry eye disease symptoms on a 5-point scale (0=none of the time and 4=all of the time). Higher scores represent greater disability. Scores are totaled over the 12 questions and converted to a score of 0-100 (0=no disability and 100=complete disability). A negative number change from baseline represents an improvement and a positive number change from baseline represents a worsening.|Baseline, Day 35|Per Protocol: all randomized subjects who received at least one dose of the study product, had at least one follow-up visit, and who did not adhere to a pre-defined list of protocol violation criteria||Scores on a Scale||Standard Deviation|Mean
647769|NCT02117687|Secondary|Change From Baseline in Global Ocular Staining Score in the Study Eye|Global ocular staining of the study eye was graded from 0 to 15 and was the sum of corneal fluorescein staining severity, nasal conjunctiva lissamine green staining severity, and temporal conjunctiva lissamine green staining severity. Staining of the cornea followed ocular administration of fluorescein dye and was graded on a 6-point scale (0=no staining to 5=diffuse staining). Staining of the conjunctiva followed ocular administration of lissamine green dye and was graded on a 6-point scale (0=no staining to 5=diffuse staining). Conjunctival staining was evaluated in two zones, nasal and temporal.|Baseline, Month 3|Per Protocol: all randomized subjects who received at least one dose of the study product, had at least one follow-up visit, and who did not adhere to a pre-defined list of protocol violation criteria||Scores on a Scale||Standard Deviation|Mean
647770|NCT02117687|Primary|Change From Baseline in Global Ocular Staining Score in the Study Eye|Global ocular staining of the study eye was graded from 0 to 15 and was the sum of corneal fluorescein staining severity, nasal conjunctiva lissamine green staining severity, and temporal conjunctiva lissamine green staining severity. Staining of the cornea followed ocular administration of fluorescein dye and was graded on a 6-point scale (0=no staining to 5=diffuse staining). Staining of the conjunctiva followed ocular administration of lissamine green dye and was graded on a 6-point scale (0=no staining to 5=diffuse staining). Conjunctival staining was evaluated in two zones, nasal and temporal.|Baseline, Day 35|Per Protocol: all randomized subjects who received at least one dose of the study product, had at least one follow-up visit, and who did not adhere to a pre-defined list of protocol violation criteria||Scores on a Scale||Standard Deviation|Mean
647771|NCT02117570|Primary|Percentage of Participants Reporting Adverse Events (AEs) to Month 2 and Serious AEs (SAEs) to Month 13 (65- to 85-Year Age Cohort)|An AE is any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. An SAE is any untoward medical occurrence at any dose that results in death, persistent or significant disability/incapacity, or congenital anomaly/birth defect; is life-threatening; or requires or prolongs inpatient hospitalization.|AEs: From informed consent to Visit 6 (Month 2). SAEs: From informed consent to Visit 9 (Month 13)|All randomized participants aged 65 to 85 who received at least 1 dose of study vaccine||Percentage of participants||95% Confidence Interval|Number
647772|NCT02117570|Primary|Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort)|Fever=temperature ≥38.0°C (100.4°C): Mild=38.0°C to 38.4°C (100.4°F-101.1°F); moderate=38.5°C to 38.9°C (101.2°F-102.0°F); severe=39.0°C to 40.0°C (102.1°F-104.0°F); Grade 4= >40.0°C (>104.0°F). Vomiting: Mild=1 to 2 times in 24 hours; moderate= >2 times in 24 hours; severe=requires intravenous hydration; Grade 4=emergency department visit or hospitalization for hypotensive shock. Diarrhea: Mild=2 to 3 loose stools in 24 hours; moderate=4 to 5 loose stools in 24 hours; severe= ≥6 loose stools in 24 hours; Grade 4=emergency department visit or hospitalization. Headache, fatigue, new or worsening joint or muscle pain: Mild=no interference with activity; moderate=some interference with activity; severe=significant interference with activity, prevents daily activity; Grade 4=emergency department visit or hospitalization. Any systemic event: Fever ≥38.0°C, vomiting, diarrhea, headache, fatigue, or new or worsening muscle or joint pain.|From Day of Dose 3 vaccination to within 14 days after Dose 3|All randomized participants aged 65 to 85 years who received all 3 doses of study vaccine||Percentage of participants||95% Confidence Interval|Number
647773|NCT02117570|Primary|Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort)|Fever=temperature ≥38.0°C (100.4°C): Mild=38.0°C to 38.4°C (100.4°F-101.1°F); moderate=38.5°C to 38.9°C (101.2°F-102.0°F); severe=39.0°C to 40.0°C (102.1°F-104.0°F); Grade 4= >40.0°C (>104.0°F). Vomiting: Mild=1 to 2 times in 24 hours; moderate= >2 times in 24 hours; severe=requires intravenous hydration; Grade 4=emergency department visit or hospitalization for hypotensive shock. Diarrhea: Mild=2 to 3 loose stools in 24 hours; moderate=4 to 5 loose stools in 24 hours; severe= ≥6 loose stools in 24 hours; Grade 4=emergency department visit or hospitalization. Headache, fatigue, new or worsening joint or muscle pain: Mild=no interference with activity; moderate=some interference with activity; severe=significant interference with activity, prevents daily activity; Grade 4=emergency department visit or hospitalization. Any systemic event: Fever ≥38.0°C, vomiting, diarrhea, headache, fatigue, or new or worsening muscle or joint pain.|From Day of Dose 2 vaccination to within 14 days after Dose 2|All randomized participants aged 65 to 85 years who received at least 2 doses of study vaccine||Percentage of participants||95% Confidence Interval|Number
647790|NCT02117479|Secondary|Duration of Response|Duration of overall response was defined as the time in months from Complete Response (CR) or Partial Response (PR) by Response Evaluation Criteria in Solid Tumours (RECIST v1.1) until the first date Progressive Disease (PD) was objectively documented or until the date of death.|Baseline through end of study; up to 6-months or to the data cutoff 11FEB2016.|The intent-to-treat (ITT) population consisted of all participants randomized to the study.||days||95% Confidence Interval|Median
651412|NCT02029521|Secondary|Forced Vital Capacity|Forced vital capacity percent predicted|3 months|Pulmonary function tests not performed on children under the age of 5||percent predicted||Standard Deviation|Mean
647774|NCT02117570|Primary|Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort)|Fever=temperature ≥38.0°C (100.4°C): Mild=38.0°C to 38.4°C (100.4°F-101.1°F); moderate=38.5°C to 38.9°C (101.2°F-102.0°F); severe=39.0°C to 40.0°C (102.1°F-104.0°F); Grade 4= >40.0°C (>104.0°F). Vomiting: Mild=1 to 2 times in 24 hours; moderate= >2 times in 24 hours; severe=requires intravenous hydration; Grade 4=emergency department visit or hospitalization for hypotensive shock. Diarrhea: Mild=2 to 3 loose stools in 24 hours; moderate=4 to 5 loose stools in 24 hours; severe= ≥6 loose stools in 24 hours; Grade 4=emergency department visit or hospitalization. Headache, fatigue, new or worsening joint or muscle pain: Mild=no interference with activity; moderate=some interference with activity; severe=significant interference with activity, prevents daily activity; Grade 4=emergency department visit or hospitalization. Any systemic event: Fever ≥38.0°C, vomiting, diarrhea, headache, fatigue, or new or worsening muscle or joint pain.|From Day of Dose 1 vaccination to within 7 days of Dose 1|All randomized participants aged 65 to 85 years who received at least 1 dose of study vaccine||Percentage of participants||95% Confidence Interval|Number
647775|NCT02117570|Primary|Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort)|Pain at injection site: mild=does not interfere with activity; moderate=interferes with activity; severe=prevents daily activity; Grade 4=emergency department visit or hospitalization. Redness/swelling: Mild=2.5 to 5.0 cm; moderate= >5.0 to 10.0 cm; severe= >10 cm; Grade 4=necrosis or exfoliative dermatitis for redness category and only necrosis for swelling category. Any local reaction=any pain at the injection site, any swelling, or any redness.|From Day of Dose 3 vaccination to 14 days after Dose 3|All randomized participants aged 65 to 85 years who received all 3 doses of study vaccine||Percentage of participants||95% Confidence Interval|Number
647776|NCT02117570|Primary|Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort)|Pain at injection site: mild=does not interfere with activity; moderate=interferes with activity; severe=prevents daily activity; Grade 4=emergency department visit or hospitalization. Redness/swelling: Mild=2.5 to 5.0 cm; moderate= >5.0 to 10.0 cm; severe= >10 cm; Grade 4=necrosis or exfoliative dermatitis for redness category and only necrosis for swelling category. Any local reaction=any pain at the injection site, any swelling, or any redness.|From Day of Dose 2 vaccination to 14 days after Dose 2|All randomized participants aged 65 to 85 years who received at least 2 doses of study vaccine||Percentage of participants||95% Confidence Interval|Number
647777|NCT02117570|Primary|Percentage of Participants With A Local Reaction Within 7 Days of Dose 1 (65- to 85-Year Age Cohort)|Pain at injection site: mild=does not interfere with activity; moderate=interferes with activity; severe=prevents daily activity; Grade 4=emergency department visit or hospitalization. Redness/swelling: Mild=2.5 to 5.0 cm; moderate= >5.0 to 10.0 cm; severe= >10 cm; Grade 4=necrosis or exfoliative dermatitis for redness category and only necrosis for swelling category. Any local reaction=any pain at the injection site, any swelling, or any redness.|From Day of Dose 1 vaccination to within 7 days of Dose 1|All randomized participants aged 65 to 85 years who received at least 1 dose of study vaccine.||Percentage of participants||95% Confidence Interval|Number
647778|NCT02117570|Primary|Percentage of Participants Reporting Adverse Events (AEs) to Month 2 and Serious AEs (SAEs) to Month 13 (50- to 64-Year Age Cohort)|An AE is any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. An SAE is any untoward medical occurrence at any dose that results in death, persistent or significant disability/incapacity, or congenital anomaly/birth defect; is life-threatening; or requires or prolongs inpatient hospitalization.|AEs: From informed consent to Visit 6 (Month 2). SAEs: From informed consent to Visit 9 (Month 13)|All randomized participants aged 50 to 64 years who received at least 1 dose of study vaccine||Participants||95% Confidence Interval|Number
647779|NCT02117570|Primary|Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort)|Fever=temperature ≥38.0°C (100.4°C): Mild=38.0°C to 38.4°C (100.4°F-101.1°F); moderate=38.5°C to 38.9°C (101.2°F-102.0°F); severe=39.0°C to 40.0°C (102.1°F-104.0°F); Grade 4= >40.0°C (>104.0°F). Vomiting: Mild=1 to 2 times in 24 hours; moderate= >2 times in 24 hours; severe=requires intravenous hydration; Grade 4=emergency department visit or hospitalization for hypotensive shock. Diarrhea: Mild=2 to 3 loose stools in 24 hours; moderate=4 to 5 loose stools in 24 hours; severe= ≥6 loose stools in 24 hours; Grade 4=emergency department visit or hospitalization. Headache, fatigue, new or worsening joint or muscle pain: Mild=no interference with activity; moderate=some interference with activity; severe=significant interference with activity, prevents daily activity; Grade 4=emergency department visit or hospitalization. Any systemic event: Fever ≥38.0°C, vomiting, diarrhea, headache, fatigue, or new or worsening muscle or joint pain.|From Day of Dose 3 vaccination to within 14 days after Dose 3|All randomized participants aged 50 to 64 years who received all 3 doses of study vaccine||Percentage of participants||95% Confidence Interval|Number
647780|NCT02117570|Primary|Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort)|Fever=temperature ≥38.0°C (100.4°C): Mild=38.0°C to 38.4°C (100.4°F-101.1°F); moderate=38.5°C to 38.9°C (101.2°F-102.0°F); severe=39.0°C to 40.0°C (102.1°F-104.0°F); Grade 4= >40.0°C (>104.0°F). Vomiting: Mild=1 to 2 times in 24 hours; moderate= >2 times in 24 hours; severe=requires intravenous hydration; Grade 4=emergency department visit or hospitalization for hypotensive shock. Diarrhea: Mild=2 to 3 loose stools in 24 hours; moderate=4 to 5 loose stools in 24 hours; severe= ≥6 loose stools in 24 hours; Grade 4=emergency department visit or hospitalization. Headache, fatigue, new or worsening joint or muscle pain: Mild=no interference with activity; moderate=some interference with activity; severe=significant interference with activity, prevents daily activity; Grade 4=emergency department visit or hospitalization. Any systemic event: Fever ≥38.0°C, vomiting, diarrhea, headache, fatigue, or new or worsening muscle or joint pain.|From Day of Dose 2 vaccination to within 14 days after Dose 2|All randomized participants aged 50 to 64 years who received at least 2 doses of study vaccine||Percentage of participants||95% Confidence Interval|Number
647803|NCT02117310|Primary|Number of Participants for Which Angiograghy is Used to Visualize Nasoseptal Mucosa Better Than What is Done Standard of Care in This Surgery.|The researcher will administer ICG, which is already widely used during open neurosurgical procedures, to identify the blood supply at two distinct stages of endonasal cranial base surgery: during nasoseptal flap harvest and after final positioning of the nasoseptal flap to ensure its viability before ending the case. This study will determine feasibility of other larger clinical trials using this method.|During surgery|||Participants|||Count of Participants
647804|NCT02117193|Secondary|Breath Alcohol||6 months||||||
647781|NCT02117570|Primary|Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort)|Fever=temperature ≥38.0°C (100.4°C): Mild=38.0°C to 38.4°C (100.4°F-101.1°F); moderate=38.5°C to 38.9°C (101.2°F-102.0°F); severe=39.0°C to 40.0°C (102.1°F-104.0°F); Grade 4= >40.0°C (>104.0°F). Vomiting: Mild=1 to 2 times in 24 hours; moderate= >2 times in 24 hours; severe=requires intravenous hydration; Grade 4=emergency department visit or hospitalization for hypotensive shock. Diarrhea: Mild=2 to 3 loose stools in 24 hours; moderate=4 to 5 loose stools in 24 hours; severe= ≥6 loose stools in 24 hours; Grade 4=emergency department visit or hospitalization. Headache, fatigue, new or worsening joint or muscle pain: Mild=no interference with activity; moderate=some interference with activity; severe=significant interference with activity, prevents daily activity; Grade 4=emergency department visit or hospitalization. Any systemic event: Fever ≥38.0°C, vomiting, diarrhea, headache, fatigue, or new or worsening muscle or joint pain.|From Day of Dose 1 vaccination to within 7 days of Dose 1|All randomized participants aged 50 to 64 years who received at least 1 dose of study vaccine||Percentage of participants||95% Confidence Interval|Number
647782|NCT02117570|Primary|Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort)|Pain at injection site: mild=does not interfere with activity; moderate=interferes with activity; severe=prevents daily activity; Grade 4=emergency department visit or hospitalization. Redness/swelling: Mild=2.5 to 5.0 cm; moderate= >5.0 to 10.0 cm; severe= >10 cm; Grade 4=necrosis or exfoliative dermatitis for redness category and only necrosis for swelling category. Any local reaction=any pain at the injection site, any swelling, or any redness.|From Day of Dose 3 vaccination to within 14 days after Dose 3|All randomized participants aged 50 to 64 years who received all 3 doses of study vaccine.||Percentage of participants||95% Confidence Interval|Number
647783|NCT02117570|Primary|Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort)|Pain at injection site: mild=does not interfere with activity; moderate=interferes with activity; severe=prevents daily activity; Grade 4=emergency department visit or hospitalization. Redness/swelling: Mild=2.5 to 5.0 cm; moderate= >5.0 to 10.0 cm; severe= >10 cm; Grade 4=necrosis or exfoliative dermatitis for redness category and only necrosis for swelling category. Any local reaction=any pain at the injection site, any swelling, or any redness.|From Day of Dose 2 vaccination to within 14 days after Dose 2|All randomized participants aged 50 to 64 years who received at least 2 doses of study vaccine||Percentage of participants||95% Confidence Interval|Number
647784|NCT02117570|Primary|Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort)|Pain at injection site: mild=does not interfere with activity; moderate=interferes with activity; severe=prevents daily activity; Grade 4=emergency department visit or hospitalization. Redness/swelling: Mild=2.5 to 5.0 cm; moderate= >5.0 to 10.0 cm; severe= >10 cm; Grade 4=necrosis or exfoliative dermatitis for redness category and only necrosis for swelling category. Any local reaction=any pain at the injection site, any swelling, or any redness.|From Day of Dose 1 vaccination to within 7 days after Dose 1|All randomized participants aged 50 to 64 years who received at least 1 dose of study vaccine||Percentage of participants||95% Confidence Interval|Number
647785|NCT02117544|Secondary|Low Contrast Visual Acuity (LCVA) Distance Monocular|Visual Acuity (clarity or sharpness of vision) was measured at low contrast level. LCVA was assessed monocularly (each eye separately) at 6 meters using an ETDRS chart and measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value indicates better visual acuity. Both eyes contributed to the analysis.|Day 1, 10 minutes after lens insertion, each product|This analysis population includes all randomized subjects excluding those who met the critical deviation criteria as specified in the Deviations and Evaluability Plan (DEP).||logMAR|Participants|Standard Error|Least Squares Mean
647786|NCT02117544|Secondary|HCVA Intermediate Monocular|Visual Acuity (clarity or sharpness of vision) was measured at high contrast level. HCVA was assessed monocularly (each eye separately) at 1 meter using an ETDRS chart and measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value indicates better visual acuity. Both eyes contributed to the analysis.|Day 1, 10 minutes after lens insertion, each product|This analysis population includes all randomized subjects excluding those who met the critical deviation criteria as specified in the Deviations and Evaluability Plan (DEP).||logMAR|Participants|Standard Error|Least Squares Mean
647787|NCT02117544|Secondary|HCVA Distance Monocular|Visual Acuity (clarity or sharpness of vision) was measured at high contrast level. HCVA was assessed monocularly (each eye separately) at 6 meters using an ETDRS chart and measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value indicates better visual acuity. Both eyes contributed to the analysis.|Day 1, 10 minutes after lens insertion, each product|This analysis population includes all randomized subjects excluding those who met the critical deviation criteria as specified in the Deviations and Evaluability Plan (DEP).||logMAR|Participants|Standard Error|Least Squares Mean
647788|NCT02117544|Primary|High Contrast Visual Acuity (HCVA) Near Monocular|Visual Acuity (clarity or sharpness of vision) was measured at high contrast level. HCVA was assessed monocularly (each eye separately) at 40 centimeters using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart and measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value indicates better visual acuity. Both eyes contributed to the analysis.|Day 1, 10 minutes after lens insertion, each product|This analysis population includes all randomized subjects excluding those who met the critical deviation criteria as specified in the Deviations and Evaluability Plan (DEP).||logMAR|Participants|Standard Error|Least Squares Mean
647789|NCT02117479|Secondary|Participants With Treatment-Emergent Adverse Events (TEAEs)|A treatment-emergent AE was defined as an event occurring after exposure to at least 1 dose of study drug (ruxolitinib or placebo). A treatment-related AE was defined as an event with a definite, probable, or possible causality to study medication. A serious AE is an event resulting in death, hospitalization, persistent or significant disability/incapacity, or is life threatening, a congenital anomaly/birth defect or requires medical or surgical intervention to prevent 1 of the outcomes above. The intensity of an AE was graded according to the National Cancer Institute common terminology criteria for adverse events (NCI-CTCAE) version 4.03: Grade 1 (Mild); Grade 2 (Moderate); Grade 3 (Severe); Grade 4 (life-threatening).|Baseline through approximately 30 days post treatment discontinuation; up to 6-months or to the data cutoff 11FEB2016.|The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).||Participants|||Count of Participants
647791|NCT02117479|Secondary|Objective Response Rate (ORR)|Objective response rate determined by radiographic disease assessments per RECIST (v1.1), by investigator assessment and was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) by Response Evaluation Criteria in Solid Tumours (RECIST) at any post baseline visit. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI) : Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions with no worsening of non-target lesions and no new lesions; Overall Response (OR) = CR + PR.|Baseline through end of study; up to 6-months or to the data cutoff 11FEB2016.|The intent-to-treat (ITT) population consisted of all participants randomized to the study.||percentage of participants|||Number
647792|NCT02117479|Secondary|Percentage of Participants Achieving Progression Free Survival (PFS)|PFS is defined as the time from randomization until the earliest date of disease progression determined by investigator assessment of objective radiographic disease assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause if sooner. Progressive Disease (PD) is defined using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, unequivocal progression of non-target lesions, or the appearance of new lesions.|Randomization to disease progression, or death due to any cause if sooner; up to 6-months or to the data cutoff 11FEB2016.|The intent-to-treat (ITT) population consisted of all participants randomized to the study.||percentage of participants||95% Confidence Interval|Median
647793|NCT02117479|Secondary|Progression-free Survival (PFS)|Progressive Disease (PD) is defined using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, unequivocal progression of non-target lesions, or the appearance of new lesions.|Randomization to disease progression, or death due to any cause if sooner; up to 6-months or to the data cutoff 11FEB2016.|The intent-to-treat (ITT) population consisted of all participants randomized to the study.||days||95% Confidence Interval|Median
647794|NCT02117479|Primary|Overall Survival (OS)|Overall survival is reported here based on the number of deaths from randomization up to 6-months or to the data cutoff 11FEB2016.|Randomization until death due to any cause; up to the data cutoff 11FEB2016.|The intent-to-treat (ITT) population consisted of all participants randomized to the study.||Participants|||Count of Participants
647795|NCT02117414|Secondary|Atrial Sensing Amplitude|Number of successful patients, where success is defined as not decreasing atrial sensing amplitude by more than 50% from pre-MRI/waiting to one month post.|MRI/waiting visit to 1-month post-MRI/Waiting visit|Only subjects with measured atrial sensing amplitude values at both the pre-MRI/waiting period and post-MRI/waiting period were used in the analysis.||Successful participants|||Number
647796|NCT02117414|Secondary|Atrial Pacing Capture Threshold (APCT)|Number of successful patients, where success is defined as not increasing APCT by more than 0.5V from pre-MRI/waiting to one month post.|Pre-MRI/Waiting Period visit to 1-month post-MRI/Waiting Period visit|To be included in the analysis, subjects in the MRI group must undergo an MRI scan and those in the Control group must complete the MRI/waiting period visit, and all the subjects must have valid APCT measurements pre-MRI/waiting period and post-MRI/waiting period.||Successful participants|||Number
647797|NCT02117414|Secondary|Superior Vena Cava (SVC) Defibrillation Impedance|Number of subjects whose SVC defibrillation impedance at the one-month post-MRI/waiting period visit is between 20 and 100 ohms|1-month post-MRI/Waiting Period visit|Only randomized subjects with measured SVC defibrillation impedance one month post-MRI/waiting period were used in the analysis. The percentages of subjects with an SVC defibrillation impedance between 20 and 100 ohms at the one month post-MRI/waiting period visit were calculated.||Successful participants|||Number
647798|NCT02117414|Secondary|RV Defibrillation Impedance|Number of subjects whose RV defibrillation impedance at the one-month post-MRI/waiting period visit is between 20 and 100 ohms|1-month post-MRI/Waiting Period visit|Only randomized subjects with measured RV defibrillation impedance one month post-MRI/waiting period were used in the analysis. The percentages of subjects with an RV defibrillation impedance between 20 and 100 ohms at the one month post-MRI/waiting period visit were calculated.||Successful participants|||Number
647799|NCT02117414|Secondary|System-related Complications|Number of subjects free of a system-related complication. The system includes the ICD and lead(s) attached to it.|Implant to 4 months post-implant|All subjects who are successfully implanted with the Evera MRI Study System or have an implant attempt will be included in the analysis.||Successful participants|||Number
647800|NCT02117414|Primary|Ventricular Sensing Amplitude (R-wave)|Number of successful patients who do not experience a decrease in ventricular sensing amplitude of >50% from the pre-MRI/waiting period to the one month post-MRI/waiting period, or a one month post-MRI/waiting value <3mV accompanied by a decrease of >25% from the pre-MRI/waiting period to the one month post-MRI/waiting period.|Pre-MRI/Waiting Period visit to 1-month post-MRI/Waiting Period visit|Only subjects with measured ventricular sensing amplitude values both pre-MRI/waiting period and post-MRI/waiting period were used in the analysis.||Successful participants|||Number
647801|NCT02117414|Primary|Ventricular Pacing Capture Threshold (VPCT)|Number of successful patients, where success is defined as not increasing VPCT by more than 0.5V from pre-MRI/waiting to one month post.|Pre-MRI/Waiting Period visit to 1-month post-MRI/Waiting Period visit|To be included in the analysis, subjects in the MRI group must undergo an MRI scan and those in the Control group must complete the MRI/waiting period visit, and all the subjects must have valid VPCT measurements pre-MRI/waiting period and post-MRI/waiting period.||Successful participants|||Number
647802|NCT02117414|Primary|MRI-related Events|Number of patients free of MRI-related events. Events include MRI-related complications, sustained tachyarrhythmia, and MRI-related loss of pacing ability.|MRI procedure to 1-month post-MRI|A total of 156 subjects underwent an MRI scan at the MRI/waiting period visit; of them 147 were followed through the one month post-MRI visit or later and are included in the analysis.||Participants free of MRI-related events|||Number
647805|NCT02117193|Secondary|Profile of Mood States||6 months||||||
647806|NCT02117193|Secondary|Hydration Status|Urine Specific Gravity|After each sequence, up to 8 hours|||g/ml||Standard Deviation|Mean
647807|NCT02117193|Primary|Biochemical Responses|Glucose after each situation in the morning|After each sequence, up to 8 hours|||mg/dl||Standard Deviation|Mean
647810|NCT02117050|Secondary|Annualized Relapse Rate (ARR)|A relapse is defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting for at least 24 hours, and accompanied by new objective neurologic findings. Episodes indicated by neurologist as “relapse” in the subjects chart were to be recorded.|Week 24|The study enrolled only 1 subject who did not receive any dose. Thus, the data for secondary endpoint was not collected.|||||
647811|NCT02117050|Secondary|Change From Baseline in Number of Combined Unique Active (CUA) Lesions, New Time or Enlarging Constant 2 (T2) Lesions, and New Gadolinium Enhanced (Gd+) Time Constant 1 (T1) Lesions at Week 24||Baseline, Week 24|The study enrolled only 1 subject who did not receive any dose. Thus, the data for secondary endpoint was not collected.|||||
647812|NCT02117050|Secondary|Change From Baseline in Work Productivity and Activity Impairment- General Health (WPAI-GH) Questionnaire Score at Week 24|WPAI-GH questionnaire is a subject reported quantitative assessment of general health conditions on productivity. The Total WPAI-GH score assessment was to be done on an 11-point scale ranging 0 to 10, with 0 indicating that health problems had no effect on work and 10 indicating that health problems completely prevented from working.|Baseline, Week 24|The study enrolled only 1 subject who did not receive any dose. Thus, the data for secondary endpoint was not collected.|||||
647813|NCT02117050|Secondary|Change From Baseline in TSQM (Version II) - Global Satisfaction, Medication Effectiveness, Side Effects, and Convenience Subscale Scores at Week 12|The TSQM (Version II) is a validated tool that measures patient satisfaction with medical treatments using a 100-point scale. Effectiveness, side effects, convenience and global satisfaction sub-scales of TSQM were to be used to measure overall satisfaction with medication. Subject were to respond about their satisfaction or dissatisfaction with medication they are taking in terms of effectiveness, side effects, convenience and global satisfaction, each sub-scale ranging on a scale of 0 to 100, where higher scores indicated greater satisfaction.|Baseline, Week 12|The study enrolled only 1 subject who did not receive any dose. Thus, the data for secondary endpoint was not collected.|||||
647814|NCT02117050|Secondary|Change From Baseline in TSQM (Version II) - Medication Effectiveness, Side Effects, and Convenience Subscale Scores at Week 24|The TSQM (Version II) is a validated tool that measures patient satisfaction with medical treatments using a 100-point scale. Effectiveness, side effects and convenience sub-scales of TSQM were to be used to measure overall satisfaction with medication. Subject were to respond about their satisfaction or dissatisfaction with medication they are taking in terms of effectiveness, side effects and convenience, each sub-scale ranging on a scale of 0 to 100, where higher scores indicated greater satisfaction.|Baseline, Week 24|The study enrolled only 1 subject who did not receive any dose. Thus, the data for secondary endpoint was not collected.|||||
647815|NCT02117050|Secondary|Change From Baseline in TSQM (Version II) - Total Score at Week 12 and Week 24|The TSQM (Version II) is an 11-item validated tool that measures patient satisfaction with medical treatments using a 100-point scale. Total TSQM score was the average of individual sub-scale scores (effectiveness, side effects, convenience and global satisfaction) and ranged from 0 to 100, where higher scores indicated greater satisfaction.|Baseline, Week 12 and Week 24|The study enrolled only 1 subject who did not receive any dose. Thus, the data for secondary endpoint was not collected.|||||
647816|NCT02117050|Secondary|Change From Baseline in Multiple Sclerosis Quality of Life-54 (MSQoL-54) Score at Week 24|The MSQOL-54 is a multidimensional health-related quality of life measure that combines both generic and MS-specific items into a single instrument. MSQoL-54 is a 54 item questionnaire which covers 12 sub-scales along with two summary scores, and two additional single-item measures. The 12 sub-scales are: physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life, and sexual function. The 2 summary scores are the physical health composite summary and the mental health composite summary. The 2 additional single item measures are satisfaction with sexual function and change in health. Each of the 12 sub-scale scores, the 2 summary scores and 2 single item measures were to be converted into an overall Total Score ranging from 0-100, where higher scores indicated better health status.|Baseline, Week 24|The study enrolled only 1 subject who did not receive any dose. Thus, the data for secondary endpoint was not collected.|||||
647817|NCT02117050|Secondary|Change From Baseline in Patient-Determined Disease Steps Questionnaire (PDDS) Score at Week 24|PDDS questionnaire was to be used to assess the walking ability of subjects. Subjects were to describe their walking ability on scale ranging from 0 to 8, where 0 indicated normal walking and 8 indicated subject’s condition as bedridden. Lesser score indicated better walking ability.|Baseline, Week 24|The study enrolled only 1 subject who did not receive any dose. Thus, the data for secondary endpoint was not collected.|||||
647818|NCT02117050|Primary|Change From Baseline in Treatment Satisfaction Score Determined by the Global Satisfaction Sub-scale of the Treatment Satisfaction Questionnaire for Medication (TSQM [Version II]) at Week 24|The TSQM (Version II) is a validated tool that measures patient satisfaction with medical treatments using a 100-point scale. Global satisfaction sub-scale of TSQM was to be used to measure overall satisfaction with medication using a 100-point scale. Subject were to respond about their satisfaction or dissatisfaction with medication they are taking on a scale ranging from 0 to 100, where higher scores indicated greater satisfaction.|Baseline, Week 24|The study enrolled only 1 subject who did not receive any dose. Thus, the data for primary endpoint was not collected.|||||
647819|NCT02116582|Secondary|Number of Participants With Adverse Events (AEs)|A treatment-emergent adverse event (TEAE) was defined as an adverse event occurring or worsening between the start of study treatment date and the latest date of 30 days after the last dose date or the 30-day follow-up visit date, and not later than the data cut-off date or the date of death. AEs, including abnormal clinical laboratory values, were graded using the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) guidelines (V4.03).|From the first day of treatment until 30 days after the last dose or the 30 day follow-up visit date, up to the data cut-of date of 08 May 2016; median duration of treatment was 5.7 months.|The analysis population consisted of the SAF.||Participants|||Number
647857|NCT02115269|Secondary|Proportion of Patients With Significant Pain Reduction in Case of First Dose no Response|significant pain reduction defined as improvement to mild or no pain 2 hours post-dose by 4-point pain severity scale: 0 = no pain; 1 = mild headache, allowing normal activities; 2 = moderate headache, disturbing normal activities; 3 = severe headache, disabling activities, requiring bed-rest|up to 2 hours|Patients who took second IndoProCaf dose at 2 hours post-dose||percentage of participants|||Number
647820|NCT02116582|Secondary|Time to PSA Progression|The time to PSA progression was calculated as the time interval from the date of first dose to the date of first observation of PSA progression. PSA progression was defined as a ≥ 25% increase and an absolute increase of ≥ 2 μg/L (i.e., 2 ng/mL or more) above the nadir or above the baseline value for patients who did not have a decline in PSA postbaseline values, and which was confirmed by a second consecutive value obtained at least 3 or more weeks later (i.e., a confirmed rising trend) (PCWG2 criteria). The 50th percentile of KM estimates was used as the estimate of the time to PSA progression median. A 2-sided 95% CI was provided for this estimate using the BCM.|From randomization until the data cut-off date of 08 May 2016; the median duration of treatment was 5.7 months.|The analysis population consisted of the SAF.||Months||95% Confidence Interval|Median
647821|NCT02116582|Secondary|Percentage of Participants With a Prostate-specific Antigen Response|PSA response was defined as at least a 50% decrease from baseline in PSA, and was a binary variable for achieving this criteria (or not) based on the lowest PSA value observed postbaseline. Participants with no postbaseline PSA value were regarded as non-responders. 95% CI for PSA response rate was computed using the Clopper-Pearson method based on the exact binomial distribution.|From randomization until the data cut-off date of 08 May 2016; the median duration of treatment was 5.7 months.|The analysis population consisted of the SAF.||Percentage of participants||95% Confidence Interval|Number
647822|NCT02116582|Secondary|Overall Survival (OS)|OS was defined as the time from first dose to death from any cause. All events of death were included. If patients discontinued study drug before the analysis data cut-off point, only OS status was assessed every 12 weeks until the data cut-off point date or until death, whichever occurred first. For patients who were alive at the time of the analysis data cut-off point, the OS time was censored on the last date the patient was known to be alive. Death from any cause was included, regardless of whether the event occurred while the patient was still taking study drug or after the patient discontinued study drug. OS median was estimated using the KM method. A 2-sided 95% CI was provided for this estimate using the BC method.|From randomization until the data cut-off date of 08 May 2016; up to 2 years.|The analysis population consisted of the SAF.||Months||95% Confidence Interval|Median
647823|NCT02116582|Primary|Radiographic Progression-free Survival (rPFS)|Radiographic PFS, was defined as the time from first dose to the first objective evidence of radiographic disease progression or death from any cause, whichever occurred first. For patients with no documented progression event, it was censored on the date of the last disease assessment performed prior to the analysis data cut-off point. Radiographic progression (RP) for soft tissue disease was defined by Response Evaluation Criteria in Solid Tumors (RECIST) V1.1 criteria. RP for bone disease was determined according to the consensus guidelines of a modification of the Prostate Cancer Clinical Trials Working Group 2 (PCWG2) guidelines. The 50th percentile of Kaplan-Meier (KM) estimates was used as the estimate of the rPFS median. A 2-sided 95% Confidence Interval (CI) was provided for this estimate using the Brookmeyer & Crowley method (BCM).|From randomization until treatment discontinuation or the the data cut-off date of 08 May 2016, whichever occurred first; the median duration of treatment was 5.7 months.|The analysis population consisted of the SAF.||Months||95% Confidence Interval|Median
647824|NCT02116530|Secondary|Frequency of Rescue Medication|Patients were asked to record daily number of extra nausea/vomiting pills taken because they developed nausea/vomiting in the following categories: None, One, Two, More than two in Nausea and Vomiting Daily Diary Questionnaire.|Day 2 to Day 6 after chemotherapy|All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations and had rescue medication data at each time point.||Participants|||Count of Participants
647825|NCT02116530|Secondary|Mean Scores of Potential Toxicities Related to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire|Patients were asked to record daily levels of undesired sedation and appetite increase using a visual-analogue scale ranging from 0 (none) to 10 (as bad as it can be).|Baseline and day 2 to 6 days after chemotherapy|All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations and had toxicities data at each time point.||units on a scale||Standard Deviation|Mean
647826|NCT02116530|Secondary|Proportion of Patients With Complete Response|Complete response was defined as no emetic episodes and no use of rescue medication during the acute (0-24 hours), delayed (25-120 hours) and overall (0-120 hours) periods as measured by the Nausea and Vomiting Daily Diary/Questionnaire.|0 to 120 hours after chemotherapy|All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations and had data on emetic and use of rescue medication questions.||percentage of participants|||Number
647827|NCT02116530|Secondary|Median Nausea Scores|Nausea scores was measured using a visual-analogue scale ranging from 0 (none) to 10 (as bad as it can be).|Baseline and Day 2 to Day 6 after chemotherapy|All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations and had Nausea data at each time point.||units on a scale||Full Range|Median
647828|NCT02116530|Primary|Proportion of Patients With no Nausea|No nausea was defined as a response of 0 in the nausea item of Nausea and Vomiting Daily Diary/Questionnaire in the acute (0-24 hours), delayed (25-120 hours) and overall (0-120 hours) periods after chemotherapy.|0 to 120 hours after chemotherapy|All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations and had Nausea data.||percentage of participants|||Number
647829|NCT02116322|Secondary|Diagnostic Yield of the FNA Using Corkscrew Technique|Diagnostic yield was defined as the proportion of masses in which the amount of FNA-obtained cellular material was enough for the histopathologist to make the pathological diagnosis.|30 days|||percentage of masses|||Number
647830|NCT02116322|Primary|Number of Participants With Adverse Events as a Measure of Safety||30 days|||participants|||Number
647831|NCT02115984|Primary|The Quantity of Leukocytes and Neutrophils in the Blood of Patients||Baseline, Day 21 after 2nd chemotherapy (Day 42 post-baseline), Day 21 after 3rd chemotherapy (Day 63 post-baseline)|||10^9 cells/L||Inter-Quartile Range|Median
647832|NCT02115815|Secondary|Percentage of Participants Who Experience a Post-dose 3-fold Cell-mediated Immune Response to RSV F on Day 8|Seroresponse defined as a greater than or equal to (>=) 3-fold rise from baseline|Day 8|Immunogenicity population included participants in the As-treated population who had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and had baseline and/or any post-baseline result.||percentage of participants||95% Confidence Interval|Number
647833|NCT02115815|Secondary|Post-dose Geometric Mean Fold Rises (GMFRs) of T Cell Response Against Respiratory Syncytial Virus (RSV) by RSV F Enzyme-Linked Immunospot (ELISPOT)|The ELISPOT assay for F protein-specific gamma interferon-producing T cells was performed using RSV F peptides.|Day 8 and 29|"Immunogenicity population included participants in ATP who had no protocol deviation judged to have potential to interfere with generation or interpretation of an immune response, and had baseline and/or any post-baseline result. Here, N and 'n' is number of participants analysed for this outcome measure and at given time points, respectively."||fold rise||95% Confidence Interval|Geometric Mean
647834|NCT02115815|Secondary|Post-dose Geometric Mean Counts (GMCs) From Baseline of T Cell Response Against Respiratory Syncytial Virus (RSV) by RSV F Enzyme-Linked Immunospot (ELISPOT)|The ELISPOT assay for F protein-specific gamma interferon-producing T cells was performed using RSV F peptides.|Baseline (Day 1), Day 8 and 29|"Immunogenicity population included participants in ATP who had no protocol deviation judged to have potential to interfere with generation or interpretation of an immune response, and had baseline and/or any post-baseline result. Here, N and 'n' is number of participants analysed for this outcome measure and at given time points, respectively."||spot forming counts per 10^6 PBMCs||95% Confidence Interval|Geometric Mean
647835|NCT02115815|Secondary|Percentage of Participants Who Experience a Post-dose Seroresponse to Respiratory Syncytial Virus (RSV) by Anti-Fusion Protein (F) Immunoglobulin G (IgG) Assay|Seroresponse defined as a greater than or equal to (>=) 4-fold rise from baseline.|Day 29|Immunogenicity population included participants in the As-treated population who had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and had baseline and/or any post-baseline result.||percentage of participants||95% Confidence Interval|Number
647836|NCT02115815|Secondary|Post-dose Geometric Mean Fold Rises (GMFRs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by Anti-Fusion Protein (F) Immunoglobulin G (IgG) Assay|Anti F IgG antibodies were determined by a multiplex IgG assay developed on the Meso Scale discovery platform.|Day 29, 61, 91, 181, 271 and 361|"Immunogenicity population included participants in the As-treated population who had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and had baseline and/or any post-baseline result. Here, n is number of participants analysed for this outcome measure at give time points."||fold rise||95% Confidence Interval|Geometric Mean
647837|NCT02115815|Secondary|Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by Anti-Fusion Protein (F) Immunoglobulin G (IgG) Assay|Anti F IgG antibodies were determined by a multiplex IgG assay developed on the Meso Scale discovery platform.|Baseline (Day 1), Day 29, 61, 91, 181, 271 and 361|"Immunogenicity population included participants in ATP who had no protocol deviation judged to have potential to interfere with generation or interpretation of an immune response, and had baseline and/or any post-baseline result. Here, n is number of participants analysed for this outcome measure at give time points."||titer||95% Confidence Interval|Geometric Mean
647838|NCT02115815|Secondary|Percentage of Participants Who Experience a Post-dose Seroresponse to Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay|Seroresponse defined as a greater than or equal to (>=) 4-fold rise from baseline.|Day 29|Immunogenicity population included participants in the As-treated population who had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and had baseline and/or any post-baseline result.||percentage of participants||95% Confidence Interval|Number
647839|NCT02115815|Secondary|Post-dose Geometric Mean Fold Rises (GMFRs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay|RSV neutralizing antibody titers were measured using green fluorescent protein tagged RSV A 2.|Day 29, 61, 91, 181, 271 and 361|"Immunogenicity population included participants in the As-treated population who had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and had baseline and/or any post-baseline result. Here, n is number of participants analysed for this outcome measure at give time points."||fold rise||95% Confidence Interval|Geometric Mean
647840|NCT02115815|Secondary|Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay|RSV neutralizing antibody titers were measured using green fluorescent protein tagged RSV A 2|Baseline (Day 1), Day 29, 61, 91, 181, 271 and 361|"Immunogenicity population included participants in the As-treated population who had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and had baseline and/or any post-baseline result. Here, n is number of participants analysed for this outcome measure at give time points."||titer||95% Confidence Interval|Geometric Mean
647841|NCT02115815|Primary|Number of Participants With Treatment-Emergent Adverse Events of Special Interest (TEAESIs), Treatment-Emergent Serious Adverse Events (TESAEs) and Treatment-Emergent New Onset Chronic Disease (NOCDs)|An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received investigational product. A serious adverse event (SAE) was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study product and Day 361 that were absent before treatment or that worsened relative to pretreatment state. An AESI was one of scientific and medical interest specific to understanding of study product and may have required close monitoring and rapid communication by investigator to the sponsor. A NOCD was a newly diagnosed medical condition that is of a chronic, ongoing nature. It was observed after receiving investigational product and was assessed by investigator as medically significant.|From Day 1 to Day 361|As-treated Population (ATP) included participants who received any study investigational product.||participants|||Number
647856|NCT02115269|Secondary|Proportion of Patients With Significant Pain Reduction in Case of Headache Relapse|significant pain reduction defined as improvement to mild or no pain 2 hours post-dose by 4-point pain severity scale: 0 = no pain; 1 = mild headache, allowing normal activities; 2 = moderate headache, disturbing normal activities; 3 = severe headache, disabling activities, requiring bed-rest|up to 48 hours|Patients who had headache relapse. Headache relapse was defined as a worsening of headache attack after 24 hours of the initial dosing and pain-free at 2h but no later than 48 hours of initial IndoProCaf dosing.||percentage of participants|||Number
647842|NCT02115815|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received investigational product. A serious adverse event (SAE) was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study product and Day 361 that were absent before treatment or that worsened relative to pretreatment state.|From Day 1 to Day 28|As-treated Population (ATP) included participants who received any study investigational product.||participants|||Number
647843|NCT02115815|Primary|Number of Participants With Solicited Symptoms|Solicited symptoms: tenderness or soreness at site of injection, pain at site of injection, fatigue or tiredness, headache, generalized muscle aches, swelling at the site of injection, redness at the site of injection, fever greater than or equal to (>=) 100.4 degrees F by any route from Day 1 to Day 7.|Day 1 to Day 7|As-treated Population (ATP) included participants who received any study investigational product.||participants|||Number
647844|NCT02115581|Primary|Improvement in Left Ventricular Filling Abnormality|Doppler-derived transmitral blood flow and pulmonary venous blood flow data were used for grading of the severity of diastolic filling abnormality in patients before and after the intervention. Diastolic filling abnormality was categorized as: 1- normal 2- abnormal relaxation 3- pseudonormal 4- restricted pattern based on echo data. The proportion of patients who showed improvement in the diastolic function grading was compared between the study groups.|6 months|||Percentage|||Number
647845|NCT02115581|Primary|Improvement in Left Ventricular Ejection Fraction|Ejection Fraction of left ventricle (percentage of blood pumped out of left ventricle with each heart beat) calculated by echocardiography|6 months|||Percentage||Standard Deviation|Mean
647846|NCT02115581|Secondary|Adverse Events|Number of patients with evidence of adverse reaction to coenzyme Q10 including nausea, vomiting, changes in blood pressure, neurological signs or any abnormal behavior like disquiet in young children.|6 months|||Participants|||Number
647847|NCT02115321|Secondary|Percentage of Participants Achieving Sustained Viral Response 24 Weeks After Completing Study Therapy (SVR24)|SVR24 was defined as HCV RNA levels <LLoQ 24 weeks after completing study therapy. HCV RNA was measured with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay which has a LLoQ of 15 IU/mL and a limit of detection of 15 IU/mL.|Week 36|The FAS consists of all randomized participants who received at least one dose of study medication.||Percentage of participants||95% Confidence Interval|Number
647848|NCT02115321|Secondary|Percentage of Participants Achieving Sustained Viral Response 4 Weeks After Completing Study Therapy (SVR4)|SVR4 was defined as HCV RNA levels <LLoQ 4 weeks after completing study therapy. HCV RNA was measured with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay which has a LLoQ of 15 IU/mL and a limit of detection of 15 IU/mL.|Week 16|The FAS consists of all randomized participants who received at least one dose of study medication.||Percentage of participants||95% Confidence Interval|Number
647849|NCT02115321|Secondary|Percentage of Participants With HCV RNA <LLoQ at Weeks 2, 4, and 12|HCV RNA was measured with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay which has a LLoQ of 15 IU/mL and a limit of detection of 15 IU/mL.|Weeks 2, 4, and 12|Per protocol, this measure was to be determined in Arm 4 (Part C); however, enrollment was halted after Part A and thus no data are available.|||||
647850|NCT02115321|Secondary|Percentage of Participants With HCV RNA Undetectable at Weeks 2, 4, and 12|HCV RNA was measured with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay which has a LLoQ of 15 IU/mL and a limit of detection of 15 IU/mL.|Week 2, 4, and 12|Per protocol, this measure was to be determined in Arm 4 (Part C); however, enrollment was halted after Part A and thus no data are available.|||||
647851|NCT02115321|Secondary|Mean Change From Baseline in Model for End-Stage Liver Disease (MELD) Scores in CP-B Participants|The MELD score provides an objective and granular assessment of liver improvement as a continuous variable. The calculation of MELD score is based on three biochemical variables (serum bilirubin, creatinine and international normalized ratio [INR] of prothrombin time). The MELD equation is as follows: 9.57 x ln(creatinine mg/dL) +3.78 x ln(bilirubin mg/dL) +11.2 x ln (INR) + 6.43. Scores are multiplied by 10 and rounded to the nearest whole number and range from 6 (less ill) to 40 (gravely ill). MELD scores were determined at Baseline (Day 1) and again at Week 12, Follow-up (FU) Week 12 (Week 24), and FU Week 24 (Week 36). Change from baseline in MELD score = Post-baseline MELD score - baseline MELD score.|Baseline and Weeks 12, 24, and 36|All CP-B participants in the FAS (all randomized participants who received at least one dose of study medication) with available data.||Units on a scale||Standard Deviation|Mean
647852|NCT02115321|Primary|Number of Participants Discontinuing Study Drug Due to an AE|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 12 weeks|The APaT population consisted of all randomized participants who received at least one dose of study medication.||Number of participants|||Number
647853|NCT02115321|Primary|Number of Participants Experiencing an Adverse Event (AE) During Treatment and First 14 Follow-up Days|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 14 weeks|The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one dose of study medication.||Number of participants|||Number
647854|NCT02115321|Primary|Percentage of Participants Achieving Sustained Viral Response 12 Weeks After Completing Study Therapy (SVR12)|SVR12 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) levels below the lower limit of quantification (LLoQ) 12 weeks after completing study therapy. HCV RNA was measured with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay which has a LLoQ of 15 IU/mL and a limit of detection of 15 IU/mL.|Week 24|The Full Analysis Set (FAS) consists of all randomized participants who received at least one dose of study medication.||Percentage of participants||95% Confidence Interval|Number
647855|NCT02115269|Secondary|Proportion of Patients Who Are Satisfied With Different Medicines Previously Used for Headache Attack|Defined as good and very good by Likert-type scale (e.g. very poor, poor, no opinion, good, very good)|baseline|Patients who took trip tans in the past (data are from Safety set which included all enrolled patients who have taken at least one dose of IndoProCaf).||percentage of participants|||Number
647858|NCT02115269|Secondary|Time to Significant Pain Reduction|Time to significant pain reduction (i.e. 1, 2, 4, 6 or 24 hours post-dose) will be summarized with number of patients in each category; significant pain reduction is defined as improvement to mild or no pain 2 hours post-dose by 4-point pain severity scale: 0 = no pain; 1 = mild headache, allowing normal activities; 2 = moderate headache, disturbing normal activities; 3 = severe headache, disabling activities, requiring bed-rest|up to 24 hours post-dose|Number of patients in full analysis set. Full analysis set included all patients who signed informed consent and complied with all the inclusion and exclusion criteria and who had at least one acceptable headache attack treated with IndoProCaf documented in the patient’s diary. This population was used for the effectiveness endpoints reporting.||participants|||Number
647859|NCT02115269|Primary|Proportion of Patients Who Are Satisfied With IndoProCaf Treatment|defined as good and very good by Likert-type scale (e.g. very poor, poor, no opinion, good, very good)|up to 24 hours post dose|Number of patients in full analysis set. Full analysis set included all patients who signed informed consent and complied with all the inclusion and exclusion criteria and who had at least one acceptable headache attack treated with IndoProCaf documented in the patient’s diary. This population was used for the effectiveness endpoints reporting.||percentage of participants|||Number
647860|NCT02115269|Primary|Proportion of Patients With Significant Pain Reduction|significant pain reduction defined as improvement to mild or no pain 2 hours post-dose by 4-point pain severity scale: 0 = no pain; 1 = mild headache, allowing normal activities; 2 = moderate headache, disturbing normal activities; 3 = severe headache, disabling activities, requiring bed-rest|up to 2 hours|Number of patients in full analysis set. Full analysis set included all patients who signed informed consent and complied with all the inclusion and exclusion criteria and who had at least one acceptable headache attack treated with IndoProCaf documented in the patient’s diary. This population was used for the effectiveness endpoints reporting.||percentage of participants|||Number
647861|NCT02115256|Secondary|Tachycardia|Number of participants that had tachycardia|average of 1 hour|||Participants|||Count of Participants
647862|NCT02115256|Secondary|Need for Cesarean Delivery|Number of participants that needed a cesarean delivery|average of 1 hour|||Participants|||Count of Participants
647863|NCT02115256|Secondary|Hypotension|Number of participants with hypotension|average of 1 hour|||Participants|||Count of Participants
647864|NCT02115256|Primary|Successful Version of the Fetus Into the Vertex Position|Number of participants that had successful version of the fetus into the vertex position.|average of 1 hour|||Participants|||Count of Participants
647865|NCT02114931|Secondary|Change From Parent Study Baseline in Disease Activity Score 28-C-reactive Protein (DAS28-CRP)|"The DAS28-CRP is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables:
The number of swollen and tender joints assessed using the 28-joint count;
C-reactive protein (CRP) level
Patient's global assessment of disease activity assessed on a score from 0 to 100 transformed from the result measured on a horizontal scale from 0 (no RA activity at all) to 10 (worst RA activity imaginable).
The DAS28-CRP score ranges from approximately zero to ten. Higher DAS28-CRP scores indicate higher disease activity."|Parent study baseline, extension study baseline and weeks 4, 24, 48 and 70|Full analysis set with available data at each time point||units on a scale||Standard Deviation|Mean
647866|NCT02114931|Secondary|Percentage of Participants With an American College of Rheumatology (ACR) 20 Response|"A participant was a responder if the following 3 criteria for improvement from Baseline of the parent study were met:
≥ 20% improvement in tender joint count;
≥ 20% improvement in swollen joint count; and
≥ 20% improvement in at least 3 of the 5 following parameters:
Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
Patient's global assessment of disease activity (measured on a likert scale from 0 to 10);
Physician's global assessment of disease activity (measured on a likert scale from 0 to 10);
Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);
C-Reactive Protein level."|Parent study baseline, extension study baseline and weeks 4, 24, 48, and 70|The full analysis set (all participants enrolled in the extension study) with available data at each time point||percentage of participants|||Number
647867|NCT02114931|Primary|Percentage of Participants Who Developed Antibodies to ABP 501|"Two validated assays were used to detect the presence of anti-drug antibodies. All samples were first tested in an electrochemiluminescence (ECL)-based bridging immunoassay to detect anti-drug antibodies against ABP 501 (Binding Antibody Assay). Samples confirmed to be positive for binding antibodies were subsequently tested in a non-cell based bioassay to determine neutralizing activity against ABP 501. If a sample was positive for binding antibodies and demonstrated neutralizing activity at the same time point, the sample was defined as positive for neutralizing antibodies.
Preexisting antibody positive indicates participants with a positive result at baseline of the extension study. Developing antibody positive indicates participants with a negative or no result at baseline of the extension study who were positive at any time point post-baseline during the extension study."|Up to week 72|The anti-drug antibody analysis set includes participants who received at least 1 dose of ABP 501 in the extension study and who had at least 1 evaluable antibody test assay against ABP 501 in the extension study.||percentage of participants|||Number
647868|NCT02114931|Primary|Number of Participants With Grade ≥ 3 Hematology and Chemistry Laboratory Results|"Laboratory results were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 according to the following scale:
1 = mild; 2 = moderate; 3 = severe; 4 = life-threatening; 5 = fatal."|From the first dose of study drug in the extension study to 28 days following the last dose; 72 weeks|Safety analysis set||participants|||Number
647869|NCT02114931|Primary|Number of Participants With Adverse Events|"Adverse events (AEs) were graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 according to the following scale:
1 = mild; 2 = moderate; 3 = severe; 4 = life-threatening; 5 = fatal. A treatment-related AE is defined as an event where the answer to the question “is there a reasonable possibility that the event may have been caused by the Investigational Medicinal Product” was yes.
A serious adverse event is defined as an AE that meets at least 1 of the following serious criteria:
fatal
life threatening (places the subject at immediate risk of death)
requires inpatient hospitalization or prolongation of existing hospitalization
results in persistent or significant disability/incapacity
congenital anomaly/birth defect
other medically important serious event."|From the first dose of study drug in the extension study to 28 days following the last dose; 72 weeks|The safety analysis set included all participants enrolled and treated with at least 1 dose of ABP 501 in the extension study.||participants|||Number
647870|NCT02114892|Primary|Diastolic Blood Pressure at Week 12|The diastolic blood pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the diastolic blood pressure at week 12|Week 12|All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)||mmHg||Standard Deviation|Mean
647871|NCT02114892|Primary|Waist Circumference at Week 12|Waist circumference was evaluated at baseline and at week 12 with a flexible tape and the entered values reflect the waist circumference measure at week 12|Week 12|All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)||cm||Standard Deviation|Mean
647872|NCT02114892|Secondary|Uric Acid at Week 12.|The uric acid levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the uric acid levels at week 12|Week 12.|All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)||µmol/l||Standard Deviation|Mean
647873|NCT02114892|Secondary|Creatinine at Week 12.|The creatinine levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the creatinine levels at week 12|Baseline. Week 12.|All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)||µmol/l||Standard Deviation|Mean
647874|NCT02114892|Secondary|Low Density Lipoproteins (c-LDL) at Week 12|The c-LDL levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the c-LDL levels at week 12|Week 12|All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)||mg/dL||Standard Deviation|Mean
647875|NCT02114892|Secondary|Total Cholesterol at Week 12|The total cholesterol was estimated by standardized techniques at baseline and week 12 and the entered values reflect the total cholesterol level at week 12|Week 12|All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)||mg/dL||Standard Deviation|Mean
647876|NCT02114892|Secondary|Body Mass Index at Week 12|The Body Mass index was calculated at baseline and at week 12 with the Quetelet index and the entered values reflect the body mass index at week 12|Week 12|All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)||kg/m2||Standard Deviation|Mean
647877|NCT02114892|Secondary|Weight at Week 12.|The weight was measured at baseline, week 4, week 8 and week 12 with a bioimpedance balance and the entered values reflect the weight at week 12|Week 12|All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)||kg||Standard Deviation|Mean
647878|NCT02114892|Primary|Total Insulin Sensitivity at Week 12.|The insulin sensitivity was calculated at baseline and week 12 with Matsuda index and the entered values reflect the insulin sensitivity at week 12|Week 12|All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)||unitless||Standard Deviation|Mean
647879|NCT02114892|Primary|Total Insulin Secretion at Week 12.|The total insulin secretion was calculated at baseline and week 12 with insulinogenic index and the entered values reflect the total insulin secretion at week 12|Week 12|All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)||unitless||Standard Deviation|Mean
647880|NCT02114892|Primary|First Phase of Insulin Secretion at Week 12.|The first phase of insulin secretion was calculated at baseline and week 12 with Stumvoll index and the entered values reflect the first phase of insulin secretion at week 12|Week 12|All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)||unitless||Standard Deviation|Mean
647881|NCT02114892|Primary|Systolic Blood Pressure at Week 12.|The systolic blood pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the systolic blood pressure at week 12|Week 12|All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)||mmHg||Standard Deviation|Mean
647882|NCT02114892|Primary|Fasting Glucose Levels at Week 12.|The fasting glucose levels were evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the fasting glucose level at week 12|Week 12|All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)||mmol/L||Standard Deviation|Mean
647883|NCT02114892|Primary|High Density Lipoprotein (c-HDL) Levels at Week 12.|The c-HDL levels were evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the c-HDL level at week 12|Week 12|All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)||mg/dL||Standard Deviation|Mean
647884|NCT02114892|Primary|Triglycerides Levels at Week 12|The triglycerides were evaluated at baseline and week 12 with enzymatic-colorimetric techniques and the entered values reflect the triglycerides level at week 12|Week 12|All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)||mg/dL||Standard Deviation|Mean
647885|NCT02114268|Secondary|Number of Participants With Positive Anti-Drug Antibody (ADA)|Participants were tested for anti-drug antibody to MEDI8897 prior to enrollment, predose and postdose.|Predose and Day 15, 31, 91, 181, 271 and 361|The As-treated Population included participants who receive any study investigational product.||participants|||Number
647886|NCT02114268|Secondary|Volume of Distribution (Vz) for MEDI8897|The Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a study drug. Apparent volume of distribution (Vz/F) for the IM dose groups. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation).|Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361|Pharmacokinetic parameter analysis population included all randomized population treated with MEDI8897. Number of participants analyzed signifies those participants who were evaluable for the measure.||milliliter (ml)||Standard Deviation|Mean
648154|NCT02108171|Other Pre-specified|Duration From Intranasal Drug Administration to Anesthesia Intubation of Patients Receiving Intranasal Dexmedetomidine|Duration of minutes From Intranasal Drug Administration to Anesthesia Intubation of Patients Receiving Intranasal dexmedetomidine surgical data of Patients Receiving Intranasal dexmedetomidine.|1 day|||minutes|||Number
647887|NCT02114268|Secondary|Systemic Clearance (CL) for MEDI8897|Systemic Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body. The total systemic clearance after the dose was estimated by dividing the total administered dose by the Area Under the Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]). Apparent clearance (CL/F) for the IM dose groups. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation).|Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361|Pharmacokinetic parameter analysis population included all randomized population treated with MEDI8897. Number of participants analyzed signifies those participants who were evaluable for the measure.||ml per day||Standard Deviation|Mean
647888|NCT02114268|Secondary|Terminal Phase Elimination Half Life (t1/2) for MEDI8897|The terminal elimination half-life (t1/2) is the time measured for the serum concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z). Here ‘n’ signifies participants evaluable for specified categories, for each arm, respectively. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation).|Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361|Pharmacokinetic parameter analysis population included all randomized population treated with MEDI8897. Number of participants analyzed signifies those participants who were evaluable for the measure.||Day||Standard Deviation|Mean
647889|NCT02114268|Secondary|Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) for MEDI8897|The AUC (0-infinity) is the area under the serum concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the serum concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation).|Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361|Pharmacokinetic parameter analysis population included all randomized population treated with MEDI8897. Number of participants analyzed signifies those participants who were evaluable for the measure.||Day*microgram per milliliter||Standard Deviation|Mean
647890|NCT02114268|Secondary|Maximum Observed Serum Concentration (Cmax) for MEDI8897|The Cmax is the maximum observed serum concentration of MEDI8897. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation).|Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361|Pharmacokinetic parameter analysis population included all randomized population treated with MEDI8897. Number of participants analyzed signifies those participants who were evaluable for the measure.||microgram per milliliter (mcg/ml)||Standard Deviation|Mean
647891|NCT02114268|Secondary|Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI8897|The Tmax is defined as actual sampling time to reach maximum observed MEDI8897 concentration. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation).|Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361|Pharmacokinetic parameter analysis population included all randomized population treated with MEDI8897. Number of participants analyzed signifies those participants who were evaluable for the measure.||Day||Standard Deviation|Mean
647892|NCT02114268|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) is defined as events present at baseline that worsened in intensity after administration of investigational products or events absent at baseline that emerged after administration of study drug, for the period extending to 391 (Day 361 ± 30 days) days after the last dose of study drug.|From start of study drug administration up to Day 391 (Day 361 +/- 30 days)|The As-treated population included participants who receive any study investigational product.||participants|||Number
647893|NCT02114216|Secondary|PAR2 and IL-8 Expression of Esophageal Mucosa|The primers used in real-time qPCR were designed using PrimerExpress Software V2.0 (Applied Biosystems, Foster City, CA, USA) based on sequence information from the National Center for Biotechnology Information database. Real-time qPCR was performed in triplicate by using a StepOnePlus Real-time PCR (Applied Biosystems) with SYBR Premix Ex TaqTM (Takara Bio, Shiga, Japan) according to manufacturers’ instructions and protocols. Thermal cycling was performed as follows: initial denaturation at 95 °C for 10s followed by 40 cycles of 95 °C for 5 s and 60 °C for 33s. Homo b-actin was used as a reference; i.e. each sample was normalized on the basis of its b-actin content. The relative change in all target genes expression was determined by the fold-change analysis.|up to 24weeks|||Fold change||Standard Error|Mean
647894|NCT02114216|Primary|TRPV1, GDNF, and NGF mRNA Expression of Esophageal Mucosa|The primers used in real-time qPCR were designed using PrimerExpress Software V2.0 (Applied Biosystems, Foster City, CA, USA) based on sequence information from the National Center for Biotechnology Information database. Real-time qPCR was performed in triplicate by using a StepOnePlus Real-time PCR (Applied Biosystems) with SYBR Premix Ex TaqTM (Takara Bio, Shiga, Japan) according to manufacturers’ instructions and protocols. Thermal cycling was performed as follows: initial denaturation at 95 °C for 10s followed by 40 cycles of 95 °C for 5 s and 60 °C for 33s. Homo b-actin was used as a reference; i.e. each sample was normalized on the basis of its b-actin content. The relative change in all target genes expression was determined by the fold-change analysis.|up to 24weeks|||Fold change||Standard Error|Mean
647895|NCT02114177|Secondary|Change From Baseline in EuroQol 5 Dimension (EQ-5D) Visual Analogue Scale|"The EQ-5D questionnaire is a brief, generic health-related quality of life assessment (HRQOL) that can also be used to incorporate participant preferences into health economic evaluations. The EQ-5D questionnaire assesses HRQOL in terms of degree of limitation on 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and as overall health using a thermometer visual analog scale with response options ranging from 0 (worst imaginable health) to 100 (best imaginable health). Lower scores indicate worsening."|Baseline (Day 1), Week 4, Week 8, Week 12, Follow-up Week 4, Follow-up Week 12 and Follow-up Week 24|The ITT population included all the randomized participants who took at least 1 dose of study drug. Here, “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure and ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.||units on a scale||Standard Error|Mean
647896|NCT02114177|Secondary|Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) Scores|The CES-D scale assesses how often during the past week participants experienced 20 symptoms commonly associated with major depression. CES-D scores range from 0 (no symptoms) to 60 (all 20 symptoms most or all of the time during the past 5-7 days). The CES-D scores between 16 and 23 points indicate mild to moderate depressive illness while CES-D scores greater than or equal to 23 indicate probable major depressive illness.|Baseline (Day 1), Week 4, Week 8, Week 12, Follow-up Week 4, Follow-up Week 12 and Follow-up Week 24|The ITT population included all the randomized participants who took at least 1 dose of study drug. Here, “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure and ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.||units on a scale||Standard Error|Mean
647897|NCT02114177|Secondary|Change From Baseline in Fatigue Severity Scale (FSS) Score up to Follow-up Week 24|The FSS was a self-administered questionnaire with 9 items developed to assess disabling fatigue that has been used extensively in studies of chronic HCV infection. Item responses were measured on a 7point Likert scale ranging from strongly disagree (1 point) to strongly agree (7 points). The 9 items were averaged to produce a total score; a lower total score indicates less severe fatigue. FSS scores have a range from 1 to 7 where higher scores indicate more severe fatigue.|Baseline (Day 1), Week 4, Week 8, Week 12, Follow-up Week 4, Follow-up Week 12 and Follow-up Week 24|The ITT population included all the randomized participants who took at least 1 dose of study drug. Here, “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure and ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.||units on a scale||Standard Error|Mean
647898|NCT02114177|Secondary|Change From Baseline in Hepatitis C Symptom and Impact Questionnaire 4 (HCV-SIQv4) Overall Body System Score (OBSS)|HCVSIQv4 OBSS was a self-administered questionnaire that contained 33 items: 29 questions developed to assess severity or frequency of symptoms associated with HCV or its treatment, 3 questions regarding the impact of symptoms on work/school attendance, and 1 question regarding the impact of symptoms on daily activities. A symptom severity score (the mean of responses to the 29 symptom items); each symptom score was transformed to have a range from 0 to 100 (most severe). Higher HCV SIQv4 scores indicates worse symptom severity, more time missed from work/school, and more impairment in daily activities, respectively.|Baseline (Day 1), Week 4, Week 8, Week 12, Follow-up Week 4, Follow-up Week 12 and Follow-up Week 24|The ITT population included all the randomized participants who took at least 1 dose of study drug. Here, “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure and ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.||units on a scale||Standard Error|Mean
647899|NCT02114177|Secondary|Percentage of Participants With Viral Relapse|Percentage of participants who did not achieve sustained virologic response 12, have less than 25 IU/mL undetectable plasma HCV RNA at end of treatment, and greater than or equal to 25 IU/mL plasma HCV RNA during the follow-up phase.|Up to Week 24|The ITT population included all the randomized participants who took at least 1 dose of study drug. Here, “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.||Percentage of participants|||Number
647900|NCT02114177|Secondary|Percentage of Participants With Viral Breakthrough|Percentage of participants with greater than 1 log10 IU/mL increase in plasma Hepatitis C virus ribonucleic acid level from the lowest level reached (ie, lowest value measured in between baseline and current value), or a confirmed plasma HCV RNA level of greater than 100 IU/mL in participants whose plasma HCV RNA had previously been less than 25 IU/mL.|Up to Week 24|The ITT population included all the randomized participants who took at least 1 dose of study drug.||Percentage of participants|||Number
647901|NCT02114177|Secondary|Percentage of Participants Achieving a On-treatment Virologic Response|Ontreatment virologic response was determined by HCV RNA results satisfying a specified threshold. <LLOQ undetectable was considered as threshold at any time point. The LLOQ value is 25 IU/mL. EOT=End of Treatment.|Day 14, Day 28, End of treatment (Week 8 or Week 12)|The ITT population included all the randomized participants who took at least 1 dose of study drug. Here, ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.||Percentage of participants|||Number
647902|NCT02114177|Secondary|Percentage of Participants Achieving a Sustained Virologic Response 24 Weeks After the Actual End of Treatment (SVR24)|Participants considered to have achieved SVR24, if the hepatitis C virus ribonucleic acid (HCV RNA) is less than (<) lower limit of quantification (LLOQ; 25 international unit per milliliter [IU/mL]) detectable or undetectable at 24 weeks after the Actual end of study drug treatment.|24 weeks after the end of treatment (EOT) (Week 32 or Week 36)|Intent-to-treat (ITT) population included all the randomized participants who took at least 1 dose of study drug.||Percentage of participants||95% Confidence Interval|Number
647903|NCT02114177|Secondary|Percentage of Participants Achieving a Sustained Virologic Response 4 Weeks After the Actual End of Treatment (SVR4)|Participants considered to have achieved SVR4, if the hepatitis C virus ribonucleic acid (HCV RNA) is less than (<) lower limit of quantification (LLOQ; 25 international unit per milliliter [IU/mL]) detectable or undetectable at 4 weeks after the actual end of study drug treatment.|4 weeks after the end of treatment (EOT) (Week 12 or Week 16)|Intent-to-treat (ITT) population included all the randomized participants who took at least 1 dose of study drug.||Percentage of Participants||95% Confidence Interval|Number
647904|NCT02114177|Primary|Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Actual End of Treatment (SVR12)|Participants considered to have achieved SVR12, if the hepatitis C virus ribonucleic acid (HCV RNA) is less than (<) lower limit of quantification (LLOQ; 25 international unit per milliliter [IU/mL]) detectable or undetectable at 12 weeks after the actual end of study drug treatment.|12 weeks after the end of treatment (EOT) (Week 20 or Week 24)|Intent-to-treat (ITT) population included all the randomized participants who took at least 1 dose of study drug.||Percentage of participants||95% Confidence Interval|Number
647915|NCT02114151|Secondary|Percentage of Participants With a Sustained Virologic Response (SVR) 4 Weeks After the Actual End of Treatment (EOT)|Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) 25 international unit per milliliter (IU/mL) (detectable or undetectable) at 4 weeks after the actual end of treatment.|Week 16|Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication.||Percentage of Participants||95% Confidence Interval|Number
647905|NCT02114151|Secondary|Number of Participants Not Achieving SVR Showing Emerging Mutation at Time of Failure in HCV NS3/4A Sequence and NS5B up to Follow-up Week 24|Sequencing of the HCV nonstructural protein 3/4A (NS3/4A) and nonstructural protein 5B (NS5B) genes was done to identify pre-existing sequence polymorphisms and characterize emerging HCV viral variants in participants not achieving SVR. Sequencing data is available for 16 participants.|Baseline, Day 3, Week 1, 2, 3, 4, 8, 12, Follow-up Week 4, 12 and 24|Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication. Here, “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.||Participants|||Number
647906|NCT02114151|Secondary|Change From Baseline in EuroQol 5 Dimension Questionnaire (EQ-5D) up to Follow-up Week 24|"The EQ-5D questionnaire was a brief, generic health-related quality of life (HRQOL) assessment that could also be used to incorporate participant preferences into health economic evaluations. The EQ-5D questionnaire assessed HRQOL in terms of degree of limitation on 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and as overall health using a thermometer visual analog scale with response options ranging from 0 (worst imaginable health) to 100 (best imaginable health)."|Baseline, Follow-up Week 12 and 24|Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication. Here, “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure and ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.||Units on a Scale||Standard Error|Mean
647907|NCT02114151|Secondary|Percentage of Participants With Depression by Using Center for Epidemiologic Studies Depression Scale (CES-D)|The CES-D Scale assessed how often during the past week participants experienced 20 symptoms commonly associated with major depression. The CES-D scores range from 0 (no symptoms) to 60 (all 20 symptoms most or all of the time during the past 5 to 7 days). The CES-D scores between 16 and 23 points indicate mild to moderate depressive illness while CES-D scores >=23 indicate probable major depressive illness.|Baseline, Week 12, Follow-up Week 12 and 24|Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication. Here, “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure and ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.||Percentage of Participants|||Number
647908|NCT02114151|Secondary|Change From Baseline in Fatigue Severity Score (FSS) up to Follow-up Week 24|The FSS was a self-administered questionnaire with 9 items developed to assess disabling fatigue that has been used extensively in studies of chronic HCV infection. Item responses were measured on a 7-point Likert scale ranging from strongly disagree (1 point) to strongly agree (7 points). The 9 items were averaged to produce a total score; a lower total score indicates less severe fatigue. FSS scores have a range from 1 to 7 where higher scores indicate more severe fatigue.|Baseline, Week 12, Follow-up Week 12 and 24|Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication. Here, “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure and ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.||Units on a Scale||Standard Error|Mean
647909|NCT02114151|Secondary|Change From Baseline in Hepatitis C Symptom and Impact Questionnaire Version 4 (HCV-SIQv4) Overall Body System Score (OBSS) up to Follow-up Week 12|The HCV-SIQv4 OBSS was a self-administered questionnaire that contained 33 items: 29 questions developed to assess severity or frequency of symptoms associated with HCV or its treatment, 3 questions regarding the impact of symptoms on work/school attendance, and 1 question regarding the impact of symptoms on daily activities. A symptom severity score (the mean of responses to the 29 symptom items); each symptom score was transformed to have a range from 0 to 100 (most severe). Higher HCV SIQv4 scores indicates worse symptom severity, more time missed from work/school, and more impairment in daily activities, respectively.|Baseline, Week 4, Week 12 and Follow-Up Week 12|Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication. Here, “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure and ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.||Units on a Scale||Standard Error|Mean
647910|NCT02114151|Secondary|Percentage of Participants With Viral Relapse|Viral relapse was defined as participants who did not achieve SVR12 and had HCV RNA < LLOQ (25 IU/mL) undetectable at EOT and had HCV RNA >= LLOQ (25 IU/mL) during the follow-up period.|During the Follow-up (Week 24)|Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication. Here “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.||Percentage of Participants|||Number
647911|NCT02114151|Secondary|Percentage of Participants With Viral Breakthrough|Viral breakthrough was defined as confirmed greater than (>) 1 log10 increase in HCV RNA from nadir or confirmed HCV RNA >100 IU/mL in participants who had previously achieved HCV RNA < LLOQ (25 IU/mL).|Up to End of Treatment (Week 12)|Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication.||Percentage of Participants|||Number
647912|NCT02114151|Secondary|Percentage of Participants With On-treatment Failure|On-treatment failure is defined as participants who do not achieve SVR12 and with confirmed detectable HCV RNA at the actual end of study drug treatment.|Week 12|Intent-to-treat (ITT) population included all randomized participants who took at least one dose of investigational drug.||Percentage of Participants|||Number
647913|NCT02114151|Secondary|Percentage of Participants With On-treatment Virologic Response|On-treatment virologic response was determined by HCV RNA results satisfying a specified threshold. <LLOQ undetectable was considered as threshold at any time point. The LLOQ value is 25 IU/mL. EOT=End of Treatment.|Week 2, 4 and End of Treatment (Week 12)|Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication. Here ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.||Percentage of Participants|||Number
647914|NCT02114151|Secondary|Percentage of Participants With a Sustained Virologic Response (SVR) 24 Weeks After the Actual End of Treatment (EOT)|Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) 25 international unit per milliliter (IU/mL) (detectable or undetectable) at 24 weeks after the actual end of treatment.|Week 36|Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication.||Percentage of Participants||95% Confidence Interval|Number
647916|NCT02114151|Primary|Percentage of Participants With a Sustained Virologic Response (SVR) 12 Weeks After the Actual End of Treatment (EOT)|Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) 25 international unit per milliliter (IU/mL) (detectable or undetectable) at 12 weeks after the actual end of treatment.|Week 24|Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication.||Percentage of Participants||95% Confidence Interval|Number
647917|NCT02113579|Secondary|Global Subjective VAS Score at Week 4|At each visit, participants rated their perception of the pain/discomfort experienced by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. Participants were instructed as follows:“Please rate the intensity of the pain/discomfort you have experienced in the last two weeks when drinking cold/hot beverages and/or foods, eating sweet and sour foods, breathing cold air, brushing your teeth or performing any habits/behaviors that elicit your dentinal hypersensitivity pain/discomfort since you have been using the product.” The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm.|4 Weeks|Analysis was based on the Full Analysis Set, which included all randomized subjects.||units on a scale (mm)||Standard Error|Least Squares Mean
647918|NCT02113579|Secondary|Global Subjective VAS Score at Week 2|At each visit, participants rated their perception of the pain/discomfort experienced by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. Participants were instructed as follows:“Please rate the intensity of the pain/discomfort you have experienced in the last two weeks when drinking cold/hot beverages and/or foods, eating sweet and sour foods, breathing cold air, brushing your teeth or performing any habits/behaviors that elicit your dentinal hypersensitivity pain/discomfort since you have been using the product.” The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm.|2 Weeks|Analysis was based on the Full Analysis Set, which included all randomized subjects.||units on a scale (mm)||Standard Error|Least Squares Mean
647919|NCT02113579|Secondary|Mean Tactile Sensitivity VAS Score at Week 4|Tooth sensitivity was measured using a Visual Analogue Scale (VAS). At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|4 Weeks|Analysis was based on the Full Analysis Set, which included all randomized subjects.||units on a scale (mm)||Standard Error|Least Squares Mean
647920|NCT02113579|Secondary|Mean Tactile Sensitivity VAS Score at Week 2|Tooth sensitivity was measured using a Visual Analogue Scale (VAS). At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|2 Weeks|Analysis was based on the Full Analysis Set, which included all randomized subjects.||units on a scale (mm)||Standard Error|Least Squares Mean
647921|NCT02113579|Secondary|Percentage of Subjects With Reduction From Baseline by at Least 30% in Mean Cold Air VAS Stimulus Score at Week 2|Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant. A participant was considered an individual success if the participant's mean cold air stimulus VAS score at Week 2 was at least 30% lower than the participant's mean baseline cold air stimulus VAS score.|2 Weeks|Analysis was based on the Full Analysis Set, which included all randomized subjects.||percentage of participants|||Number
647922|NCT02113579|Secondary|Mean Tactile Sensitivity Score at Week 2|Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant, at each visit.|2 Weeks|Analysis was based on the Full Analysis Set, which included all randomized subjects.||grams||Standard Error|Least Squares Mean
647923|NCT02113579|Secondary|Mean Cold Air Stimulus VAS Score at Week 2|Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|2 Weeks|Analysis was based on the Full Analysis Set, which included all randomized subjects.||units on a scale (mm)||Standard Error|Least Squares Mean
647924|NCT02113579|Secondary|Mean Tactile Sensitivity Score at Week 4|Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant, at each visit.|4 Weeks|Analysis was based on the Full Analysis Set, which included all randomized subjects.||grams||Standard Error|Least Squares Mean
647957|NCT02112370|Secondary|Maximum of Measured Diastolic Blood Pressures|The maximal diastolic blood pressure is monitored during surgery.|participants were followed for the duration of the operation, an average of approximately 2.5 hours|||mmHg||Standard Deviation|Mean
647958|NCT02112370|Secondary|Maximum of Measured Systolic Blood Pressures|The maximal systolic blood pressure is monitored during surgery.|participants were followed for the duration of the operation, an average of approximately 2.5 hours|||mmHg||Standard Deviation|Mean
647925|NCT02113579|Secondary|Mean Cold Air Stimulus VAS Score at Week 4|Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|4 Weeks|Analysis was based on the Full Analysis Set, which included all randomized subjects.||units on a scale (mm)||Standard Error|Least Squares Mean
647926|NCT02113579|Primary|Percentage of Subjects With Reduction From Baseline by at Least 30% in Mean Cold Air VAS Stimulus Score at Week 4|Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant. A participant was considered an individual success if the participant's mean cold air stimulus VAS score at Week 4 was at least 30% lower than the participant's mean baseline cold air stimulus VAS score.|4 Weeks|Analysis was based on Full Analysis Set, which included all randomized subjects.||percentage of participants|||Number
647927|NCT02113449|Primary|Provide a Score From 1-7 to Some Statements, Depending on How Much You Think Each Statement Applies or Does Not Apply to the Spray Product That You Used|A score of 1 indicates that the statement does not apply at all to the product that you used. A score of 7 indicates that it applies completely to it. You can use any score from 1 to 7 to indicate how much or how little you think the statement applies to this product|7 days|The per protocol (PP) population was the primary population for analysis. Of the 143 participants who completed this study, 10 participants had device failure (device that did not perform well), and therefore 133 participants were included in PP population.||Participants|||Number
647928|NCT02113449|Primary|How Often do You Think This Spray Product Would Last for You Personally?|There was one questionnaire used in this study which is divided into 3 parts: screening survey, after product trial questions, and at home usage experience. This question was asked after at-home use of the product. Participants could select only one option.|7 days|The per protocol (PP) population was the primary population for analysis. Of the 143 participants who completed this study, 10 participants had device failure (device that did not perform well), and therefore 133 participants were included in PP population.||Participants|||Number
647929|NCT02113449|Primary|Which One Statement Best Describes How Often, if Ever, You Think You Would Buy the Spray Product in the Future?|There was one questionnaire used in this study which is divided into 3 parts: screening survey, after product trial questions, and at home usage experience. This question was asked after at-home use of the product. Participants could select only one option.|7 days|The per protocol (PP) population was the primary population for analysis. Of the 143 participants who completed this study, 10 participants had device failure (device that did not perform well), and therefore 133 participants were included in PP population.||Participants|||Number
647930|NCT02113449|Primary|How Many Packages Would You Buy?|There was one questionnaire used in this study which was divided into 3 parts: screening survey, after product trial questions, and at home usage experience.This question was asked after at-home use of the product. Participants could select only one option.|7 days|The per protocol (PP) population was the primary population for analysis. Of the 143 participants who completed this study, 10 participants had device failure (device that did not perform well), and therefore 133 participants were included in PP population.||Participants|||Number
647931|NCT02113449|Primary|If the Product You Just Tried (After At-home Use) Was Available for the Following Price: $12.99 for 40 Doses, How Likely Would You be to Buy it?|There was one questionnaire used in this study which was divided into 3 parts: screening survey, after product trial questions, and at home usage experience. This question was asked after at-home use of the product. Participants could select only one option.|7 days|The per protocol (PP) population was the primary population for analysis. Of the 143 participants who completed this study, 10 participants had device failure (device that did not perform well), and therefore 133 participants were included in PP population.||Participants|||Number
647932|NCT02113449|Primary|Divide 11 Points Between Two Products (CO2 Nasal Spray and Brand Selected at Q1)?|There was one questionnaire used in this study which was divided into 3 parts: screening survey, after product trial questions, and at home usage experience. This question was asked after at-home use of the product. Participants could select only one option. It was done to compare the spray with the product selected by the participant in Q1. There were 11 points between the two products that participants could divide anyways thet wanted (11-0, 10-1, 9-2, 8-3, 7-4 or 6-5 etc). The more the participant liked a product compared to other, the higher the number of points were to be given to that product.|7 days|The per protocol (PP) population was the primary population for analysis. Of the 143 participants who completed this study, 10 participants had device failure (device that did not perform well), and therefore 133 participants were included in PP population.||Participants|||Number
647933|NCT02113449|Primary|Which of the Following Statements Best Describes the Extent to Which the Spray Reached Your Expectations?|There was one questionnaire used in this study which was divided into 3 parts: screening survey, after product trial questions, and at home usage experience. This question was asked after at-home use of the product. Participants could select only one option.|7 days|The per protocol (PP) population was the primary population for analysis. Of the 143 participants who completed this study, 10 participants had device failure (device that did not perform well), and therefore 133 participants were included in PP population.||Participants|||Number
647934|NCT02113449|Primary|Would You be Interested in Taking the Spray Product Home and Using it Over the Next Week?|There was one questionnaire used in this study which was divided into 3 parts: screening survey, after product trial questions, and at home usage experience. This question was asked after the first dose of the product. Participants could select only one option.|7 days|The per protocol (PP) population was the primary population for analysis. Of the 143 participants who completed this study, 10 participants had device failure (device that did not perform well), and therefore 133 participants were included in PP population.||Participants|||Number
647935|NCT02113449|Primary|If the Product You Just Tried (After First Dose) Was Available for the Following Price: $12.99 for 40 Doses, How Likely Would You be to Buy it?|There was one questionnaire used in this study which was divided into 3 parts: screening survey, after product trial questions, and at home usage experience. This question was asked after the first dose of the product. Participants could select only one option.|7 days|The per protocol (PP) population was the primary population for analysis. Of the 143 participants who completed this study, 10 participants had device failure (device that did not perform well), and therefore 133 participants were included in PP population.||Participants|||Number
647936|NCT02113449|Primary|Which of the Statements Best Describes the Extent to Which the Spray Reached Your Expectations?|There was one questionnaire used in this study which was divided into 3 parts: screening survey, after product trial questions, and at home usage experience. This question was asked after the first use. Participants could select only one option.|7 days|The per protocol (PP) population was the primary population for analysis. Of the 143 participants who completed this study, 10 participants had device failure (device that did not perform well), and therefore 133 participants were included in PP population.||Participants|||Number
647937|NCT02113449|Primary|Which One Product That Relieves Nasal Congestion do You Buy Most Often?|"There was one questionnaire used in this study which was divided into 3 parts: screening survey, after product trial questions, and at home usage experience. This question was asked as part of screening survey prior to concept viewing. If the participant answered I do not purchase any product to relieve congestion the participant was excluded. Participants could select only one option available."|7 days|The per protocol (PP) population was the primary population for analysis. Of the 143 participants who completed this study, 10 participants had device failure (device that didnot perform well), and therefore 133 participants were included in PP population.||Participants|||Number
647938|NCT02113436|Secondary|Mean Change From Baseline in Total Asthma Symptom Score (Daytime Plus Night Time) at the End of the Treatment Period 2 (TP2)|The participant's parent or legally acceptable representative recorded asthma symptoms experienced by the participant in a patient diary twice daily (daytime and night time) in the form of scores on a 4-point rating scale from Baseline (Week -1) until end of TP2 (Week 24). Scores ranged from 0 (none) to 3 (severe) and maximum score is 6 per day. Change from Baseline in the asthma symptom scores at daytime plus night time at the end of TP2 was analyzed. The Baseline value is a mean value of the last 7 consecutive days during the run-in period (excluding the day of Visit 2 [Randomization]).The end of the TP2 value is a mean value of the last 7 consecutive days during the TP2 (excluding the last day of the TP2). Change from Baseline is the difference between the value of the endpoint at the time point of interest and the Baseline value. Participants who received at least one dose of open-label medication in the TP2 were analyzed.|Baseline and Week 24|ITT Population||Scores on a scale||Standard Deviation|Mean
647939|NCT02113436|Secondary|Mean Change From Baseline in Use of Rescue Medication (Percentage of Days With Rescue-free 24-hour Period) at the End of Treatment Period 1 (TP1)|The number of inhalations of rescue salbutamol inhalation aerosol (medication used to relieve symptoms immediately) used during the day and night was recorded by the participant's parent or legally acceptable representative twice daily in a patient diary. A 24-hour period in which a participant's responses to both the morning and evening assessments indicated no use of rescue medication was considered as rescue free. Participants who were rescue free for 24-hour periods during the 8-week Treatment Period were assessed. The Baseline value was derived from the last 7 days of the patient diary prior to the randomization of the participant. Change from Baseline is the difference between the value of the endpoint at the time point of interest and the Baseline value. Participants who completed TP1 and completed their diary were analyzed.|Baseline and Week 8|ITT Population||Percentage of days||Standard Error|Least Squares Mean
647940|NCT02113436|Secondary|Mean Change From Baseline in Use of Rescue Medication (Number of Occasions Used During a 24-hour Period) in Treatment Period 1 (TP1)|The number of inhalations of rescue salbutamol inhalation aerosol (medication used to relieve symptoms immediately) used during the day and night was recorded by the participant's parent or legally acceptable representative twice daily in a patient diary from Baseline (Week -1) until Week 8. A 24-hour period in which a participant's responses to both the morning and evening assessments indicated no use of rescue medication was considered as rescue free. Participants who were rescue free for 24-hour periods during the 8 weeks in TP1 were assessed. The Baseline value was derived from the last 7 days of the patient diary prior to the randomization of the participant. Change from Baseline is the difference between the value of the endpoint at the time point of interest and the Baseline value. Participants who completed TP1 and completed their diary were analyzed.|Baseline and Week 8|ITT Population||Occasions per 24 hours||Standard Error|Least Squares Mean
647941|NCT02113436|Secondary|Mean Change From Baseline in Japanese Pediatric Asthma Control Program (JPAC) Score at the End of Treatment Period 1 (TP1)|Severity and control statuses based on Japanese pediatric guideline for the treatment and management of asthma (JPGL) can be assessed according to JPAC. Theoretically range of JPAC score was 0 (poor control) to 18 (complete control) point. JPAC questionnaire was recorded at Baseline (Week -2) and Week 8 by the participant's parent or legally acceptable representative who knew the participant's asthma for the last month. Change from Baseline is the difference between the value of the endpoint at the time point of interest and the Baseline value. Participants who completed TP1 were analyzed.|Baseline and Week 8|ITT Population||Scores on a scale||Standard Error|Least Squares Mean
647942|NCT02113436|Secondary|Number of Participants With at Least One Asthma Exacerbation in Treatment Period 1 (TP1)|The definition of exacerbations was amended during the study. <Original> An exacerbation is defined as deterioration of asthma requiring the use of systemic corticosteroids (oral, parenteral, or depot) for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. <Amendment> An asthma exacerbation is defined as deterioration of asthma requiring the use of prednisone or hydrocortisone equivalent systemic corticosteroids for at least 3 days, or requiring the use of dexamethasone or betametasone equivalent systemic corticosteroids (oral, intravenous or intramuscular), or requiring the use of systemic depot corticosteroids once, or an in-patient hospitalization that required treatment for respiratory symptom with wheezing, or emergency department visit due to asthma that required intravenous systemic corticosteroids.|Up to 8 weeks|ITT Population||Participants|||Number
648155|NCT02108171|Other Pre-specified|Duration From Intranasal Drug Administration to Anesthesia Intubation of Patients Receiving Intranasal Placebo|Duration from intranasal drug administration to anesthesia intubation of Patients Receiving Intranasal Placebo surgical data of patients receiving intranasal placebo|1 day|||minutes|||Number
647943|NCT02113436|Secondary|Mean Change From Baseline in Daytime Asthma Symptoms Score at the End of Treatment Period 1 (TP1)|The participant's parent or legally acceptable representative recorded asthma symptoms experienced by the participant during the day in a patient diary in the form of scores on a 4-point rating scale from Baseline (Week -1) until end of TP1 (Week 8). Scores ranged from 0 to 3(0: one, 1: mild, 2: moderate, 3: severe) and maximum score is 3 per day. Change from Baseline in the asthma symptom scores at day time at the end of TP1 was analyzed. The Baseline value is a mean value of the last 7 consecutive days during the run-in period (excluding the day of Visit 2 [Randomization]). The end of the TP1 value is a mean value of the last 7 consecutive days during the TP1 (excluding the last day of the TP1). Change from Baseline is the difference between the value of the endpoint at the time point of interest and the Baseline value. Participants who completed TP1 and completed their diary were analyzed.|Baseline and Week 8|ITT Population.||Scores on a scale||Standard Error|Least Squares Mean
647944|NCT02113436|Secondary|Mean Change From Baseline in Night-time Asthma Symptoms Score at the End of Treatment Period 1 (TP1)|The participant's parent or legally acceptable representative recorded asthma symptoms experienced by the participant during the night in a patient diary in the form of scores on a 4-point rating scale from Baseline (Week -1) until end of TP1 (Week 8). Scores ranged from 0 to 3(0: one, 1: mild, 2: moderate, 3: severe) and maximum score is 3 per day. Change from Baseline in the asthma symptom scores at night time at the end of TP1 was analyzed. The Baseline value is a mean value of the last 7 consecutive days during the run-in period (excluding the day of Visit 2 [Randomization]). The end of the TP1 value is a mean value of the last 7 consecutive days during the TP1 (excluding the last day of the TP1). Change from Baseline is the difference between the value of the endpoint at the time point of interest and the Baseline value. Participants who completed TP1 and completed their diary were analyzed.|Baseline and Week 8|ITT Population||Scores on a scale||Standard Error|Least Squares Mean
647945|NCT02113436|Primary|Mean Change From Baseline in Total Asthma Symptom Score (Daytime Plus Night Time) at the End of the Treatment Period 1 (TP1)|The participant’s parent or legally acceptable representative made entries asthma symptom experienced by the participant in a patient diary twice daily (day time and night time) in the form of scores on a 4-point rating scale from Baseline (Week -1) until end of TP1 (Week 8). Scores ranged from 0 to 3(0: one, 1: mild, 2: moderate, 3: severe) and maximum score is 6 per day. The Baseline value is a mean value of the last 7 consecutive days during the run-in period (excluding the day of Visit 2 [Randomization]). The end of the TP1 value is a mean value of the last 7 consecutive days during the TP1 (excluding the last day of the TP1). Change from Baseline is the difference between the value of the endpoint at the time point of interest and the Baseline value. Participants who completed TP1 and completed their diary were analyzed.|Baseline and Week 8|ITT Population: all randomized par. who received at least one dose of study medication.||Scores on a scale||Standard Error|Least Squares Mean
647946|NCT02113124|Primary|Change From Baseline of Concentrations of Essential Amino Acid at 1.5 Hours After Eating|5 ml of blood will be acquired following a 8-hour fasting period to determine baseline concentrations of amino acids. A meal will then be provided and another blood sample will be acquired 90 minutes after completing the meal to examine the change in amino acid concentration. These samples will be used to determine the levels of each essential amino acid present.|Samples collected on day 1 following 8 hour fasting period and again 90 minutes after eating a predetermined meal|||µM||Standard Error|Mean
647947|NCT02113007|Secondary|Number of Participants With Serious and Non-serious Adverse Events as a Measure of Safety.|Patients in the safety lead-in part of the study were monitored for up to 2 treatment cycles (4 weeks) to assure there were no unexpected or prohibitive toxicities. A non-serious adverse event is any untoward medical occurrence. A serious adverse event (SAE) is an event that meets one or more of the following: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; requires intervention to prevent permanent impairment or damage. Specific AE and SAE terms are provided in the Adverse event module.|up to 4 weeks|||participants|||Number
647948|NCT02113007|Secondary|Progression Free Survival (PFS)|Six and twelve-month CNS progression-free survival rate.|6 and 12 months|The study closed early due to slow accrual; outcome measure not reached.|||||
647949|NCT02113007|Primary|Overall Response Rate|Patients will be assessed for response by MRI of brain and/or spine after 4 cycles (8 weeks) of treatment according to Response Criteria for Primary CNS Lymphoma. Patients with stable disease or better (CR or PR) will continue treatment for 12 cycles (24 weeks). Complete Response (CR)=no contrast enhancement, normal eye exam. Partial Response (PR)=50 percent decrease in tumor enhancement, minor retinal pigment epithelium abnormality in eye exam. Stable disease (SD)= a change in lesion size that is neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for progressive disease.|approximately 32 weeks|The study closed early due to slow accrual. This outcome measure was not reached.|||||
647950|NCT02112448|Secondary|Length of Stay|Length of stay will be recorded for each subject.|From date of randomization until the date of first documented progression or date of death from any cause or discharge, whichever came first, assessed up to 100 months|||days||Standard Deviation|Mean
647951|NCT02112448|Primary|Total Morphine Dosage|Total dose of morphine used will be recorded for each patient.|24 hours|||mg/kg||Standard Deviation|Mean
647952|NCT02112370|Secondary|Pain Killer Dose|Change in pain killer usage with time|0, 1, 2, 4, 6, 9, 12, 24, and 48 hours post operation|||vials (15mg ketorolac per vial)||Standard Deviation|Mean
647953|NCT02112370|Secondary|NRS Change|"Change in NRS score a with time The numerical rating scale is utilized to assess the postoperative pain change for the first 12 hours according to location.
Range: 0(minimal pain, better outcome) ~ 10(maximum pain, worse outcome)"|0, 1, 2, 4, 6, 9, 12, 24, and 48 hours post operation|||scores on a scale||Standard Deviation|Mean
647954|NCT02112370|Secondary|Operation Time|The amount of time taken from start to the end of surgery|participants were followed for the duration of the operation, an average of approximately 2.5 hours|||minutes||Standard Deviation|Mean
647955|NCT02112370|Secondary|Blood Loss Amount|The blood loss amount is estimated at the end of surgery.|participants were followed for the duration of the operation, an average of approximately 2.5 hours|||ml||Standard Deviation|Mean
647956|NCT02112370|Secondary|Maximum of Measured Heart Rates|The maximal heart rate is monitored during surgery.|participants were followed for the duration of the operation, an average of approximately 2.5 hours|||beats per minute||Standard Deviation|Mean
647959|NCT02112370|Primary|NRS Pain Scores for the First 12 Hours|"The numerical rating scale is utilized to assess the postoperative pain change for the first 12 hours according to location.
Range: 0(minimal pain, better outcome) ~ 10(maximum pain, worse outcome)
Unlike the general NRS pain score as reported in the post-operative 48 hour result which deals with post-operative discomfort in general, this outcome measures the pain score of the specific location in which flap dissection had taken place."|Postoperative 12 hours|||points||Standard Deviation|Mean
647960|NCT02111863|Secondary|Overall Survival (OS) of Patients Receiving a Lymphocyte Depleting Preparative Regimen|OS is defined as the time between the first day of treatment to the day of death or date last known alive.|up to 3 years|||months||Full Range|Median
647961|NCT02111863|Primary|Objective Response Rate of Patients With Metastatic Melanoma|Objective response is defined as complete response + partial response and was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.|approximately 2 years|||percentage of participants|||Number
647962|NCT02111863|Primary|Count of Participants With Serious and Non-Serious Adverse Events|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE) v3.0. A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|2 years and 59 days|||Participants|||Count of Participants
647963|NCT02111603|Secondary|Concordance Correlation Coefficients of the Relative Composition of Stool Total and the Main Individual Bile Acids (BA)|"Stool 48 hour collections (for BAs) were collected during baseline before treatment, and then during days 9-10 of the 10 days of colesevelam dosing for fecal BAs. Relative composition of the main individual bile acids (cholic acid (CA), chenodeoxycholic acid (CDCA), deoxycholic acid (DCA), lithocholic acid (LCA) and ursodeoxycholic acid (UDCA)) in 48 hour stool collection after colesevelam treatment were compared to baseline values.
The concordance correlation coefficient (rc) measures agreement between two variables. The concordance correlation satisfies -1 ≤ rc ≤ +1. A value of rc = +1 corresponds to perfect agreement. A value of rc = -1 corresponds to perfect negative agreement, and a value of rc = 0 corresponds to no agreement."|baseline, 10 days|13 subjects were accrued. One subject withdrew from the study after the pre-drug activities, but before the treatment activities. Only the 12 participants with complete data at both baseline and after 10 days of treatment are included in the Outcome Measure.||concordance correlation coefficient||Standard Error|Mean
647964|NCT02111603|Secondary|Change in Stool Frequency (Number of Stools Per Week)|Change in stool frequency from baseline in response to treatment with colesevelam.|baseline, 10 days|13 subjects were accrued. One subject withdrew from the study after the pre-drug activities, but before the treatment activities. Only the 12 participants with complete data at both baseline and after 10 days of treatment are included in the Outcome Measure.||Number of stools per week||Standard Error|Mean
647965|NCT02111603|Secondary|Change in Stool Consistency|"The subjects rated their stool consistency using the Bristol Stool Form Scale. The Bristol Stool Form Scale is a medical aid designed to classify the form of human feces into seven categories or types. Types 1 and 2 indicate constipation with 3 and 4 being the ideal stools especially the latter, as they are the easiest to defecate, and 5-7 tending towards diarrhea."|baseline, 10 days|13 subjects were accrued. One subject withdrew from the study after the pre-drug activities, but before the treatment activities. Only the 12 participants with complete data at both baseline and after 10 days of treatment are included in the Outcome Measure.||units on a scale||Standard Error|Mean
647966|NCT02111603|Secondary|Change in Fecal Fat Excretion|Change in fecal fat excretion from baseline in response to treatment with colesevelam|baseline, 10 days|13 subjects were accrued. One subject withdrew from the study after the pre-drug activities, but before the treatment activities. Only the 12 participants with complete data at both baseline and after 10 days of treatment are included in the Outcome Measure.||g/day||Standard Error|Mean
647967|NCT02111603|Secondary|Change in Fasting Serum C4|Change in fasting serum C4 from baseline in response to treatment with colesevelam.|baseline, 10 days|13 subjects were accrued. One subject withdrew from the study after the pre-drug activities, but before the treatment activities. Only the 12 participants with complete data at both baseline and after 10 days of treatment are included in the Outcome Measure.||ng/mL||Standard Error|Mean
647968|NCT02111603|Primary|Change in Total 48 Hour Fecal Bile Acids (BA) From Baseline in Response to Treatment With Colesevelam|Stool 48 hour collections (for BAs) were collected during baseline before treatment, and then during days 9-10 of the 10 days of colesevelam dosing for fecal BAs. Total fecal BA were measured using HPLC/tandem mass spectrometry.|baseline, 10 days|13 subjects were accrued. One subject withdrew from the study after the pre-drug activities, but before the treatment activities. Only the 12 participants with complete data at both baseline and after 10 days of treatment are included in the Outcome Measure.||uM||Standard Error|Mean
647969|NCT02111369|Primary|Change in Acoustic Spectrograms|"Objective Voice Assessment
• Using the Computerized Speech Laboratory speech and voice analysis system (KayPENTAX, Montvale, NJ)"|baseline, 2 weeks, 6 weeks|Data were not collected as investigators found the Voice Related Quality of Life (VRQOL) scale to be a better measure.|||||
647970|NCT02111369|Primary|Change in Global Voice Rating|"Patient-Reported Measure
• 0-7 ranking"|Baseline, 2 weeks, 6 weeks|Data were not collected as investigators found the Voice Related Quality of Life (VRQOL) scale to be a better measure.|||||
647988|NCT02111083|Secondary|Pharmacodynamic Parameter: Total Amount of Glucose Infused (Gtot)|The total amount of glucose infused during the euglycemic clamp procedure.|Day1, predose through 8 hours post dose in each period.|All participants who had at least one study treatment and had evaluable pharmacodynamic(PD) data.||grams (g)||Geometric Coefficient of Variation|Geometric Mean
647989|NCT02111083|Secondary|Pharmacokinetic Parameter: Time of Maximum Observed Serum Concentration (Tmax)||Day 1, predose through 8 hours post dose in each period.|All participants who had at least one study treatment and had evaluable PK data.||hours||Full Range|Median
647971|NCT02111369|Primary|Change in Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) Score|"The CAPE-V is a clinically validated perceptual voice assessment tool that is used to describe the severity of auditory-perceptual attributes of a voice problem, in a way that can be communicated among clinicians. Participant's speech is recorded and evaluated by trained listeners. Listeners indicate overall tremor severity by making a tick mark on a 1 to 100 mm visual analog scale. Total scores range from 0 to 100 where 0 is the best score and 100 is the worst score."|Baseline, 2 weeks, 6 weeks|Participants who completed all three study visits (Baseline Visit 1, Visit 2, and Visit 3).||units on a scale||Standard Deviation|Mean
647972|NCT02111369|Primary|Change in Voice-Related Quality Of Life (VRQOL) Questionnaire Score|"The VRQOL is a ten question self-reported measure that asks patients to rate responses from 1-5 (1=none, not a problem, 2=a small amount, 3=a moderate (medium) amount, 4=a lot, 5=problem is as bad as it can be). Total scores range from 0 to 100. A higher score indicates more problems interfering with day to day activities."|Baseline, 2 weeks, 6 weeks|Participants who completed all three study visits (Baseline Visit 1, Visit 2, and Visit 3).||units on a scale||Standard Deviation|Mean
647973|NCT02111369|Primary|Change in Quality of Life in Essential Tremor (QUEST) Questionnaire Score|The QUEST questionnaire is a 30 item self-reported essential tremor-specific quality of life scale that asks participants to rate responses (never/no, rarely, sometimes, frequently, always/yes, or not applicable). Total scores range between 0 to 100 where 0 is the best score and 100 is the worst score. A higher score indicates a lower quality of life.|Baseline, 2 weeks, 6 weeks|Participants who completed all three study visits (Baseline Visit 1, Visit 2, and Visit 3).||units on a scale||Standard Deviation|Mean
647974|NCT02111252|Secondary|Geometric Mean Fold Increase in SRH Antibody Titer|Geometric mean fold increase in SRH antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination, as compared to baseline.|Day 22|||Fold Change||95% Confidence Interval|Geometric Mean
647975|NCT02111252|Secondary|Seroconversion Rate of SRH Antibody Titer|Seroconversion rate as measured by SRH antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination.|Day 22|||percentage of participants||95% Confidence Interval|Number
647976|NCT02111252|Secondary|Seroprotection Rate of SRH Antibody Titer|Seroprotection rate is measured by SRH antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination.|Day 22|The full analysis set was used.||percentage of participants||95% Confidence Interval|Number
647977|NCT02111252|Secondary|GMT of Single Radial Hemolysis (SRH) Antibody Titer|GMT of single radial hemolysis (SRH) antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination.|Day 22|The full analysis set was used.||mm^2||95% Confidence Interval|Geometric Mean
647978|NCT02111252|Secondary|Geometric Mean Titer (GMT) of HI Antibody Titer|Geometric mean titer (GMT) of HI antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination|Day 22|The full analysis set was used.||titer||95% Confidence Interval|Geometric Mean
647979|NCT02111252|Secondary|Change From Baseline in Safety Electrocardiogram (ECG) Parameters|The ECG data will be analyzed into 3 categories, `normal`, `abnormal but not clinically significant` and `abnormal clinically significant`. Using these variables, shift tables (before and after vaccination) will be created by individual participant. . The definitions for the acronyms are as follows: Within Normal Limits (WNL), Not Clinically Significant (NCS), and Clinically Significant (CS).|Day 1 and Day 22|||participants|||Number
647980|NCT02111252|Secondary|Change From Baseline in Blood Pressure|For continuous variables, summary statistics of measured values and respective changes from baseline will be calculated at each evaluation time point. In addition, figures illustrating individual changes will be created. For discrete variables, shift tables (before and after vaccination) will be created.|Day 1 (Baseline), Day 8, Day 22|||mmHg||Standard Deviation|Mean
647981|NCT02111252|Primary|Geometric Mean Fold Increase in HI Antibody Titer|Geometric mean fold increase in HI antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination, as compared to baseline.|Day 22|The full analysis set was used.||Fold Change||95% Confidence Interval|Geometric Mean
647982|NCT02111252|Primary|Seroconversion Rate of HI AntibodyTiter|Seroconversion rate is measured by HI antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination. Seroconversion Rate was defined as the perccentage of participants with a baseline HI antibody titer of ≥ 10 achieving a minimal 4-fold increase, or baseline HI antibody titer of < 10 achieving an HI antibody titer of ≥ 40 for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain).|Day 22|||Percentage of participants||95% Confidence Interval|Number
647983|NCT02111252|Primary|Percentage of Participants With Seroprotection Rate of Hemagglutination Inhibition [HI] Antibody Titer|Seroprotection rate is measured by HI antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination. Seroprotection Rate was defined as the percentage of participants with HI antibody titer ≥ 40 for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain).|Day 22|The full analysis set was used.||Percentage of participants||95% Confidence Interval|Number
647984|NCT02111252|Primary|Number of Participants With Solicited Injection Site and Systemic Adverse Events|Number of participants with injection site and systemic adverse events will be tabulated in its own, and by severity and day of onset. Described if solicited adverse event term is different from the PT.|For 22 days|The safety analysis set, comprised the volunteers who received a single dose of 0.5 mL TAK-850, was used.||participants|||Number
647985|NCT02111083|Primary|Pharmacokinetic Parameter: Area Under the Curve(AUC)||Zero to infinity [AUC(0-∞)]|All participants who had at least one study treatment and had evaluable PK data.||picomole*hour/liter (pmol*h/L)||Geometric Coefficient of Variation|Geometric Mean
647986|NCT02111083|Secondary|Pharmacodynamic Parameter: Time of Maximum Glucose Infusion Rate (tRmax)||Day 1, predose through 8 hours post dose in each period.|All participants who had at least one study treatment and had evaluable PD data.||hours||Geometric Coefficient of Variation|Geometric Mean
647987|NCT02111083|Secondary|Pharmacodynamic Parameter: Maximum Glucose Infusion Rate (Rmax)|The maximum observed glucose infusion rate during the euglycemic clamp procedure.|Day 1, predose through 8 hours post dose in each period.|All participants who had at least one study treatment and had evaluable PD data.||milligrams per minute (mg/min)||Geometric Coefficient of Variation|Geometric Mean
651723|NCT02022085|Secondary|Pain|Degree of pain and discomfort.|Week 6, Week 12, Month 6|Safety population; includes all patients who received the surgical intervention.||percentage of total population|||Number
647991|NCT02111083|Primary|Pharmacokinetic Parameter: Area Under the Serum Insulin Concentration Versus Time Curve From Zero to Time of Return to Baseline (AUC0-tlast)||Day 1, predose through 8 hours post dose in each period.|All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data.||picomole*hour/liter (pmol*h/L)||Geometric Coefficient of Variation|Geometric Mean
647992|NCT02110381|Secondary|Adherence to Dual Modality Exercise (Device Guided Breathing + Isometric Hand Grip)|Subjects recorded sessions on a log; they were expected to complete 5 days/week for 8 weeks of single modality exercise for a minimum of 40 reported sessions. Results are reported as number of subjects reporting a minimum of 40 sessions.|8 weeks|||Participants|||Count of Participants
647993|NCT02110381|Secondary|Adherence to Single Modality Exercise (Device Guided Breathing or Isometric Hand Grip)|Subjects recorded sessions on a log; they were expected to complete 5 days/week for 8 weeks of single modality exercise for a minimum of 40 reported sessions. Results are reported as number of subjects reporting a minimum of 40 sessions.|8 weeks|||Participants|||Count of Participants
647994|NCT02110381|Primary|Change in Blood Pressure|Blood pressure was measured using an automated cuff with subject in a seated position for at least 5 minutes. Six measurements were recorded at 1-minute intervals. The mean was used in analysis.|8 weeks and 16 weeks|9 subjects in each group were analyzed. These subjects represent the individuals who passed started the intervention phase of the study.||mmHg (millimeters of mercury)||Standard Deviation|Mean
647995|NCT02110238|Primary|WOMAC VAS (0:None -100:Extreme) Pain Subscale Score Change From Baseline|Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) 0-100mm Pain subscale score Change from Baseline (CFB). Over weeks 3, 6, and 12 least square mean difference in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) (0mm:None - 100mm:Extreme) pain subscale score Change from Baseline (CFB). A single estimate of least squares mean was calculated using data from baseline, weeks 3, 6, and 12.|Change from Baseline (CFB) over Weeks 3, 6, and 12|Per Protocol: All subjects with at least 1 post baseline primary outcome measure and no important protocol deviations.||millimeter||95% Confidence Interval|Least Squares Mean
647996|NCT02110147|Secondary|Patients With Levels of Uridine in the Plasma Consistent With Expected Therapeutic Benefit|HOA is principally a chronic uridine deficiency disorder. The purpose of uridine triacetate administration is to provide an exogenous source of uridine. Therefore, plasma uridine levels were assessed at various time points (prior to dosing, 30 min, 1 hour, 2 hours, 4 hours, 6 hours and 8 hours) following uridine triacetate dosing to ensure levels of uridine consistent with previously observed symptomatic improvement from administration of uridine were achieved. The table below shows the number of participants with uridine levels consistent with or exceeding previously observed symptomatic improvements.|Days 1 and 28|||Participants|||Count of Participants
647997|NCT02110147|Secondary|Patients With Stable or Improved Orotic Acid and Orotidine Levels|Significantly elevated urine orotic acid levels are characteristic of patients with HOA. Therefore, urinary orotic acid and orotidine levels were assessed in patients at baseline (on uridine or uridine naïve) and on Day 28 and Day 42 following the switch to uridine triacetate. The table below shows the number of participants with stable or improved orotic acid and orotidine levels at Day 28 and Day 42 compared to baseline.|Days 28 and 42|||Participants|||Count of Participants
647998|NCT02110147|Primary|Patients With Stable Predetermined Principal Hematologic Parameters|Hereditary orotic aciduria patients will be taking uridine triacetate as replacement therapy for uridine. The primary outcome measure will be based on predetermined principal hematologic parameter(s) based on the patient's response(s) to oral uridine when dosing is switched from oral uridine to oral uridine triacetate. The primary outcome measure in patients not previously receiving uridine replacement therapy will be improvement in the patient's principal affected hematologic parameter(s) on Days 28 and 42 compared to baseline (Day 0) of the Main Study.|Days 28 and 42|||Participants|||Count of Participants
647999|NCT02109731|Primary|Delta of Apnea Hypopnea Index (AHI) as Measured by Polysomnography (PSG)|The pre-study AHI (before the NAP treatment was applied) was measured and quantified and compared to the post study AHI (after three months of NAP treatment) and the difference between pre and post therapy is reported. The AHI is an hourly rate of breathing disturbance (apneas and hypopneas per hour) that is calculated while subjects are evaluated during an overnight sleep study, with polysomnography applied (PSG). For example, while a subject is spending the night in the PSG laboratory sleeping, his/her breathing is evaluated for evidence of apneas and hypopneas during various stages of sleep. Sleep is measured with electroencephalography. And breathing is measure with respiratory excursions via chest/abdominal plethysmography recordings and airflow from the nose/mouth.|three months|subjects with a diagnosis of OSA||events per hour||Standard Deviation|Mean
648000|NCT02109640|Secondary|Pain Scores|"Overall Benefit of Analgesia Score (OBAS): Score range 0-28 with low score=high benefit. Summed from subscales of 0-4 for the following questions:
Please rate your current pain at rest on a scale between 0⁄4 minimal pain and 4⁄4 maximum imaginable pain
Please grade any distress and bother from vomiting in the past 24 h (0⁄4 not at all to 4⁄4 very much)
Please grade any distress and bother from itching in the past 24 h (0⁄4 not at all to 4⁄4 very much)
Please grade any distress and bother from sweating in the past 24 h (0⁄4 not at all to 4⁄4 very much)
Please grade any distress and bother from freezing in the past 24 h (0⁄4 not at all to 4⁄4 very much)
Please grade any distress and bother from dizziness in the past 24 h (0⁄4 not at all to 4⁄4 very much)
How satisfied are you with your pain treatment during the past 24 h (0⁄4 not at all to 4⁄4 very much) Lehmann N. British Journal of Anaesthesia 105 (4): 511–18 (2010)"|Postoperative day 3|||units on a scale||Full Range|Median
648001|NCT02109640|Secondary|Total Opioid Analgesia Consumption|Total dose of systemic and oral Oxycodone or Targinact taken in hospital or at home until discontinued by the participant|Total postoperative period of analgesic consumption, an average of 1 week|||milligram morphine equivalents||Standard Deviation|Mean
648002|NCT02109640|Primary|Prevalence of Postoperative Gut Dysfunction|The proportion of participants with gut dysfunction, defined as the presence of any of the following sufficient to delay discharge on the 3rd postoperative day: nausea, vomiting, intolerance of oral intake or constipation.|Day 3 post-op|||Participants|||Count of Participants
648003|NCT02109497|Secondary|Safety and Tolerability of PBT2 in Healthy Volunteers Measured by the Number of Participants Reporting at Least One Treatment Emergent Adverse Event||Up to 19 days after first dose of caffeine|Safety population||participants|||Number
655305|NCT01952665|Primary|Handling|Participant rating for lens handling. Collected at 4 weeks. (0-10, 0= Very Difficult, 10= Very Easy).|4 weeks|||units on a scale||Standard Deviation|Mean
648004|NCT02109497|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) of Caffeine After a Dose of PBT2 250mg|PK Per Protocol Population, as defined as all participants who received scheduled doses of both caffeine and PBT2 and had sufficient samples collected to determine PK parameters from plasma concentrations of caffeine on Day 1 and Day 12.|prior to dose on Day 1 and 12 and then 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48 hours post each dose.|||ng*hr/mL||Standard Deviation|Mean
648005|NCT02109458|Secondary|Positive Diagnostic Yield of Bronchoscopic Biopsy of ETTNA + EBUS + NB|Positive diagnostic yield of bronchoscopic biopsy of ETTNA + EBUS + NB was defined by participants having benign or malignant pathology.|Approximately 1 week upon receipt of pathology report|||participants|||Number
648006|NCT02109458|Secondary|Positive Diagnostic Yield of Bronchoscopic Biopsy of Electromagnetic Guidance Trans-thoracic Needle Aspiration (ETTNA) Alone|Positive diagnostic yield of bronchoscopic biopsy of Electromagnetic Guidance Trans-thoracic Needle Aspiration (ETTNA) alone was defined by participants having benign or malignant pathology.|Approximately 1 week upon receipt of pathology report|||participants|||Number
648007|NCT02109458|Primary|Incidence of Pneumothorax|Presence of pneumothorax assessed in participants with successful completion of biopsy.|Immediately after procedure|||participants|||Number
648008|NCT02109458|Primary|Feasibility|Feasibility assessed by number of participants with successful completion of biopsy (i.e. a biopsy was able to be obtained to collect a tissue sample)|Immediately following procedure|||participants|||Number
648009|NCT02109445|Secondary|European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire (EORTC QLQ-C30) - Phase 2|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms.|Baseline till end of treatment|As Phase 2 was not performed due to early termination, there were no participants to analyse for this outcome measure.|||||
648010|NCT02109445|Secondary|Change From Baseline in European Quality of Life Questionnaire (EQ-5D) - Phase 2|EQ-5D: 6-item participant rated questionnaire to assess health-related quality of life in terms of a single utility score. There were 2 components: a Health State Profile and a Visual Analog Scale. Published weights are available that allow for the creation of a single summary score. Overall scores range from 0-1, with low scores representing a higher level of dysfunction.|Baseline till end of treatment|As Phase 2 was not performed due to early termination, there were no participants to analyse for this outcome measure.|||||
648011|NCT02109445|Secondary|Brief Pain Inventory-Short Form (BPI-sf) Score - Phase 2|BPI-sf is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions. BPI-sf are 4 questions that assess pain intensity (worst, least, average, right now) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each question is answered on a scale ranging from 0 to 10; ‘0=No pain and 10=Pain as bad as you can imagine’. Measure can be scored by item, with lower scores being indicative of less pain or pain interference.|Day 1 of Cycle 1 and subsequent cycles; end of treatment|As Phase 2 was not performed due to early termination, there were no participants to analyse for this outcome measure.|||||
648012|NCT02109445|Secondary|Progression-free Survival (PFS) in Phase 2|PFS was defined as the time from the date of first dose to the date of the first documentation of objective tumor progression or death on study due to any cause, whichever occurred first. PFS (in months) was calculated as (first event date – date of randomization +1) divided by 30.4.|From start of study treatment, collected every 3 months until death (up to 5 years)|All randomized participants in Phase 2 were to be analyzed for PFS. However, since Phase 2 was not carried out due to early termination, no subjects were analyzed for PFS.|||||
648013|NCT02109445|Secondary|1-year and 2-year OS in Phase 2|Overall survival was the duration from randomization to death. For participants who are alive, overall survival was censored at the last contact.|From start of study treatment, collected every 3 months until death (up to 5 years)|All randomized participants in Phase 2 were to be analyzed for OS. However, since Phase 2 was not carried out due to early termination, no subjects were analyzed for OS.|||||
648014|NCT02109445|Secondary|Duration of Response (DR) for Phases 1 and 2|Duration of response (DR) defined as the difference in days between the first date criteria for progression occurred or the participant died due to any cause and the first date that criteria for a PR or CR were met. DR calculated as (months) = (progression/death date - first date of OR + 1) divided by 30.4. CR: disappearance of all target lesions. PR: at least 30% decrease in the sum of diameters of target lesions.|Baseline, every 8 weeks until disease progression or unacceptable toxicity (up to 5 years)|No participants were analyzed for this outcome measure as there were no participants with OR in Phase 1 and Phase 2 was not done.|||||
648015|NCT02109445|Secondary|Number of Participants With Objective Response (OR) in Phase 2|"Number of participants with objective response based on assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria In Solid Tumors (RECIST).
CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than (<) 10 mm). No new lesions. PR was defined as more than or equal to (>=) 30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions."|Screening till 28-35 days post last administration of study drug|No participants were analyzed for this outcome measure as Phase 2 was not done.|||||
648044|NCT02109133|Secondary|Overall Surgical Condition|overall surgical conditions using the 5-point rating scale as previously described: Grade 5 (optimal), optimal surgical conditions; grade 4 (good), nonoptimal conditions, but an intervention is not required; grade 3 (acceptable), wide surgical view, but an intervention can improve surgical conditions, grade 2 (poor), inadequate conditions, there is a visible view, but an intervention is necessary to ensure acceptable surgical conditions; grade 1 (extremely poor), inability to perform surgery; therefore, intervention is necessary.|At the end of the Steep trendelenburg position, an average of 1 hour|||units on a scale||Inter-Quartile Range|Median
648016|NCT02109445|Secondary|Number of Participants With Objective Response (OR) in Phase 1|"Number of participants with objective response based on assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria In Solid Tumors (RECIST).
CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than (<) 10 mm). No new lesions. PR was defined as more than or equal to (>=) 30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions."|Screening till 28-35 days post last administration of study drug|All enrolled participants in Phase 1 who were eligible for enrollment, received study treatment, had measurable disease and adequate baseline assessments, and had at least 1 on-study tumor assessment, were considered evaluable for response. Only 1 participant was evaluable for OR in Phase 1.||participants|||Number
648017|NCT02109445|Secondary|Plasma Decay Half-life (t1/2) for PF-03084014, Nab-P and GEM in Phase 2||Cycle 1 Day 1 till end of last cycle|As Phase 2 was not performed, no participants were analyzed for this outcome measure.|||||
648018|NCT02109445|Secondary|Plasma Decay Half-life (t1/2) for Nab-P and GEM in Phase 1||Cycle 1 (Days 1 and 15 for gemcitabine; Days 1-3 and 15-17 for nab-paclitaxel)|All treated participants who had at least 1 of the PK parameters of interest of any of the study drugs. n=number of evaluable participants for that parameter at the specified time point.||hours||Standard Deviation|Mean
648019|NCT02109445|Secondary|Volume of Distribution at Steady State (Vss) for PF-03084014, Nab-P and GEM in Phase 2||Cycle 1 Day 1 till end of last cycle|As Phase 2 was not performed, no participants were analyzed for this outcome measure.|||||
648020|NCT02109445|Secondary|Volume of Distribution at Steady State (Vss) for Nab-P and GEM in Phase 1||Cycle 1 (Days 1 and 15 for gemcitabine; Days 1-3 and 15-17 for nab-paclitaxel)|All treated participants who had at least 1 of the PK parameters of interest of any of the study drugs. n=number of evaluable participants for that parameter at the specified time point.||liters||Geometric Coefficient of Variation|Geometric Mean
648021|NCT02109445|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-03084014, Nab-P and GEM in Phase 2||Cycle 1 Day 1 till end of last cycle|As Phase 2 was not performed, no participants were analyzed for this outcome measure.|||||
648022|NCT02109445|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-03084014, Nab-P and GEM in Phase 1||PF-03084014: Cycle 1 Days 3, 15, 22; Day 1 of subsequent cycles; and end of treatment. nab-P: Cycle 1 Days 1-3 and 15-17. Gemcitabine: Cycle 1 Days 1 and 15.|All treated participants who had at least 1 of the PK parameters of interest of any of the study drugs. n=number of evaluable participants for that parameter at the specified time point.||hours||Full Range|Median
648023|NCT02109445|Secondary|Systemic Clearance (CL) of PF-03084014, Nab-P and GEM in Phase 2||Cycle 1 Day 1 till end of last cycle|As Phase 2 was not performed, no participants were analyzed for this outcome measure.|||||
648024|NCT02109445|Secondary|Systemic Clearance (CL) of Gemcitabine in Phase 1||Cycle 1 Days 1 and 15|All treated participants who had at least 1 of the PK parameters of interest of any of the study drugs. n=number of evaluable participants for that parameter at the specified time point.||liter (L)/minute (min)||Geometric Coefficient of Variation|Geometric Mean
648025|NCT02109445|Secondary|Systemic Clearance (CL) of Nab-paclitaxel in Phase 1||Cycle 1 Days 1-3, and 15-17|All treated participants who had at least 1 of the PK parameters of interest of any of the study drugs. n=number of evaluable participants for that parameter at the specified time point.||liter (L)/hour (hr)||Geometric Coefficient of Variation|Geometric Mean
648026|NCT02109445|Secondary|Maximum Observed Plasma Concentration (Cmax) for PF-03084014, Nab-P and GEM in Phase 2||Cycle 1 Day 1 till end of last cycle|As Phase 2 was not performed, no participants were analyzed for this outcome measure.|||||
648027|NCT02109445|Secondary|Maximum Observed Plasma Concentration (Cmax) for PF-03084014, Nab-P and GEM in Phase 1||PF-03084014: Cycle 1 Days 3, 15, 22; Day 1 of subsequent cycles; and end of treatment. nab-P: Cycle 1 Days 1-3 and 15-17. Gemcitabine: Cycle 1 Days 1 and 15.|All treated participants who had at least 1 of the PK parameters of interest of any of the study drugs. n=number of evaluable participants for that parameter at the specified time point.||nanogram/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
648028|NCT02109445|Secondary|Area Under the Concentration-time Curve (AUC) for PF-03084014, Nab-P and Gemcitabine in Phase 2|AUC included AUC from time 0 extrapolated to infinite time (AUCinf), AUC from time 0 to end of dosing interval (AUCtau), and AUC from time 0 to last measured concentration (AUClast).|Cycle 1 Day 1 till end of last cycle|As Phase 2 was not performed, no participants were analyzed for this outcome measure.|||||
648029|NCT02109445|Secondary|Area Under the Concentration-time Curve (AUC) for PF-03084014, Nab-P and Gemcitabine in Phase 1|AUC included AUC from time 0 extrapolated to infinite time (AUCinf), AUC from time 0 to end of dosing interval (AUCtau, tau=12 hours), and AUC from time 0 to last measured concentration (AUClast).|PF-03084014: Cycle 1 Days 3, 15, 22; Day 1 of subsequent cycles; and end of treatment. nab-P: Cycle 1 Days 1-3 and 15-17. Gemcitabine: Cycle 1 Days 1 and 15.|All treated participants who had at least 1 of the pharmacokinetic (PK) parameters of interest of any of the study drugs. n=number of evaluable participants for that parameter at the specified time point.||nanogram*hour/milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
648030|NCT02109445|Secondary|Number of Participants With Worsening QTc Results in Phase 2|Triplicate 12-lead electrocardiogram (ECG) measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) were corrected for heart rate (QTc) using Fridericia (QTcF) and Bazett (QTcB) formulas. Any change from baseline in QTc was considered as worsening in ECG and was classified accordingly to the Common Terminology Criteria (CTC) grade. Grading was as follows: prolonged QTc of 450 to 480 milliseconds (msec)=Grade 1, 481 to 500 msec=Grade 2, more than or equal to (>=) 501 msec on at least 2 seperate ECGs=Grade 3, >=501 or more than (>) 60 msec change from baseline and Torsade de pointes or polymorphic ventricular tachycardia or signs of serious arrhythmia=Grade 4.|Screening, Cycle 1 Days 1 and 22, Cycles 2 and 3 Day 1, end of treatment|Due to early termination, Phase 2 was not performed and thus no participants were analyzed for this outcome measure.|||||
648085|NCT02108223|Secondary|Fertilization Rate|fertilization rate used to measure how many oocytes become fertilized by sperm cells|up to 9 month|||percentage of fertilized oocytes|||Number
648031|NCT02109445|Secondary|Number of Participants With Worsening QTc Results in Phase 1|Triplicate 12-lead electrocardiogram (ECG) measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) were corrected for heart rate (QTc) using Fridericia (QTcF) and Bazett (QTcB) formulas. Any change from baseline in QTc was considered as worsening in ECG and was classified accordingly to the Common Terminology Criteria (CTC) grade. Grading was as follows: prolonged QTc of 450 to 480 milliseconds (msec)=Grade 1, 481 to 500 msec=Grade 2, more than or equal to (>=) 501 msec on at least 2 seperate ECGs=Grade 3, >=501 or more than (>) 60 msec change from baseline and Torsade de pointes or polymorphic ventricular tachycardia or signs of serious arrhythmia=Grade 4.|Screening, Cycle 1 Days 3 and 22, Cycles 2 and 3 Day 1, end of treatment|All enrolled participants in Phase 1 who had at least 1 ECG assessment after receiving PF-03084014.||participants|||Number
648032|NCT02109445|Secondary|Number of Participants With Clinically Significant Change From Baseline in Vital Signs at Phases 1 and 2|Following parameters were analyzed for examination of vital signs: systolic and diastolic blood pressure, heart rate, weight and body surface area.|Baseline up to 28-35 days after treatment discontinuation|All enrolled participants in Phase 1, or all randomized participants in Phase 2, who received at least 1 dose of study medication. Due to early termination of the study, vital sign evaluations were not performed.|||||
648033|NCT02109445|Secondary|Number of Participants With Laboratory Abnormalities in Phase 2|Following parameters were analyzed for laboratory examination: hematology (hemoglobin, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (urea, creatinine, glucose, calcium, sodium, potassium, chloride, magnesium, phosphate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid); urinalysis (protein, blood, microscopy[if urine tested positive for blood or protein]).|Screening; Days 1, 8, 15 of each cycle; up to 28-35 days post last administration of study drug|Due to early termination, Phase 2 was not performed and thus no participants were included in this analysis.|||||
648034|NCT02109445|Secondary|Number of Participants With Laboratory Abnormalities in Phase 1|Following parameters were analyzed for laboratory examination: hematology (hemoglobin, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (urea, creatinine, glucose, calcium, sodium, potassium, chloride, magnesium, phosphate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid); urinalysis (protein, blood, microscopy[if urine tested positive for blood or protein]).|Screening; Cycle 1 Days 1, 8, 15, 22; up to 28-35 days post last administration of study drug|All participants who received any study treatment.||participants|||Number
648035|NCT02109445|Secondary|Number of Participants With Adverse Events (AEs) by Seriousness and Relationship to Treatment in Phase 2|Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category. Severity was graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE). Grade 1=mild, Grade 2=moderate, Grade 3=Severe or medically significant but not immediately life-threatening, Grade 4=life-threatening.|Baseline up to 28-35 days post last administration of study drug|No participants were analyzed since Phase 2 was not performed.|||||
648036|NCT02109445|Secondary|Number of Participants With Adverse Events (AEs) by Seriousness and Relationship to Treatment in Phase 1|Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category. Severity was graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE). Grade 1=mild, Grade 2=moderate, Grade 3=Severe or medically significant but not immediately life-threatening, Grade 4=life-threatening.|Baseline up to 28-35 days post last administration of study drug|All enrolled participants in Phase 1 who received at least 1 dose of study medication.||participants|||Number
648037|NCT02109445|Primary|Overall Survival (OS) in Phase 2|Overall survival was the duration from randomization to death. For participants who are alive, overall survival was censored at the last contact.|From start of study treatment, collected every 3 months until death (up to 5 years)|All randomized participants in Phase 2 were to be analyzed for OS. However, since Phase 2 was not carried out due to early termination, no subjects were analyzed for OS.|||||
648038|NCT02109445|Primary|Number of Participants With Dose-limiting Toxicities (DLTs) in Cycle 1|DLT was defined as any of the following events occurring during the first cycle of treatment and considered at least possibly-related to study medication: any Grade 3 or 4 clinically-relevant non-hematologic and/or hematologic toxicity, delay of more than 2 weeks in receiving the next scheduled cycle due to persisting treatment-related toxicities.|Cycle 1 (28 days)|All enrolled participants who received study treatment and who either experienced DLT during the first cycle, or completed the 1-cycle observation period, were considered evaluable for DLT. Only 2 of the 3 participants were evaluable for DLTs.||participants|||Number
648039|NCT02109172|Primary|Weighted Mean (0-24hr) Change From Baseline FEV1 (Forced Expiratory Volume in 1 Second)|Weighted mean (0-24hr) Change from baseline FEV1 (forced expiratory volume in 1 second). Measurement is change from baseline.|Following the Day 7 AM dose -12 hours post-dose and 24 hours post-dose|||mL||Standard Error|Least Squares Mean
648040|NCT02109159|Secondary|Number of Access to the Video Generated as a Result of Video Sharing by Each Participant|The distribution of the numbers of access to the video that each participant generated will be compared using the data collected with the computer programme to track access to the videos.|After 14 days of sending the online videos|||Number of views||95% Confidence Interval|Mean
648041|NCT02109159|Primary|Number of Participants Who Forwarded the Video|A computer programme to track the access to the videos has been made. The number of people who forwarded the video will be analysed based on the data collected with this programme.|After 14 days of sending the online videos|||participants|||Number
648042|NCT02109133|Other Pre-specified|Incidence of Residual Neuromuscular Blockade||During 24hours after operation|||participants|||Number
648043|NCT02109133|Other Pre-specified|Post-operative Nausea||During 24hours after operation|||events|||Number
648086|NCT02108223|Secondary|Number of Mature Oocyte|median number of mature oocytes retrieved per participant|up to 9 month|||oocytes||Standard Deviation|Median
648045|NCT02109133|Primary|Maximum Intraocular Pressure During RALRP Under Deep Neuromuscular Blockade|maximum intraocular pressure during RALRP under deep neuromuscular blockade after being positioned in the steep Trendelenburg position with CO2 pneumoperitoneum under deep neuromuscular blockade|Maximum intraocular pressure was measured at 60 minutes after CO2 pneumoperitoneum in the ST position|||mmHg||Standard Deviation|Mean
648046|NCT02109107|Secondary|Subject Satisfaction With Study Outcome Rating|At the end of the study procedure administration phase, the subject was asked to indicate how satisfied or dissatisfied they were with any change noticed in the appearance of the thighs, hips, waist and upper abdomen area after having received the procedures with the EZ6?”, using the following five-point scale: Very Satisfied; Somewhat Satisfied; Neither Satisfied nor Dissatisfied; Not Very Satisfied; Not at All Satisfied|6 weeks|||participants|||Number
648047|NCT02109107|Secondary|Change in Body Mass Index (BMI)|Body mass index (BMI) was measured in kilograms per meter squared (kg/m2) at each evaluation point. The change in BMI measured at 6 weeks post-procedure administration relative to baseline was calculated. An increase in BMI indicated that BMI increased across the study evaluation period which is negative for study success, while a decrease in BMI indicated that BMI decreased across the study evaluation period which is positive for study success.|Baseline and 6 weeks|||kg/m2||Standard Deviation|Mean
648048|NCT02109107|Secondary|Change in Body Weight|Body weight was measured in pounds at each evaluation point. The change in body weight measured in pounds at 6 weeks post-procedure administration relative to baseline was calculated. An increase in body weight indicated that weight was gained across the study evaluation period while a decrease in body weight indicated that weight was lost across the study evaluation period.|Baseline and 6 weeks|||pounds||Standard Deviation|Mean
648049|NCT02109107|Primary|Change in Combined Circumference Measurements|"Combined circumference measurement is calculated as the sum of the measurements for the individual body areas of the right and left thighs, hips, waist and upper abdomen. Change in combined circumference measurements is calculated as the difference in measurements from baseline to after completion of the 6-week procedure administration period. A negative (-) change indicates a reduction in combined circumference measurement across the evaluation period and is positive for study success. A positive (+) change indicates an increase in combined circumference measurements across the evaluation period and is negative for study success.
A mean change for the study subject group of -3.0 inches or more in combined circumference measurements will be considered a clinically meaningful and statistically significant positive change indicative of study success."|Baseline and 6 weeks|||inches||Standard Deviation|Mean
648055|NCT02108691|Secondary|Changes in LDLc/HDLc|LDLc/HDLc was measured in study visit 1(0week) and visit 3(8 week).|8 weeks|||ratio||Standard Deviation|Mean
648056|NCT02108691|Secondary|Changes in Non-HDLc|Non-HDLc was measured in study visit 1(0week) and visit 3(8 week).|8 weeks|||mg/dl||Standard Deviation|Mean
648057|NCT02108691|Secondary|Changes in LDLc|LDLc was measured in study visit 1(0week) and visit 3(8 week).|8 weeks|||mg/dl||Standard Deviation|Mean
648058|NCT02108691|Secondary|Changes in BMI(Body Mass Index)|BMI(body mass index) was measured in study visit 1(0week) and visit 3(8 week).|8 weeks|||kg/m^2||Standard Deviation|Mean
648059|NCT02108691|Secondary|Changes in Weight|Weight was measured in study visit 1(0 week)and visit 3(8 week).|8 weeks|||kg||Standard Deviation|Mean
648060|NCT02108691|Secondary|Changes in Percent Body Fat|Percent Body Fat was measured in study visit 1(0 week) and visit 3(8 week).|8 weeks|||percentage||Standard Deviation|Mean
648061|NCT02108691|Primary|Changes in Body Fat Mass|Body Fat Mass was measured in study visit 1(0 week) and visit 3(8 week).|8 weeks|||g||Standard Deviation|Mean
648062|NCT02108652|Secondary|Percentage of Participants Positive for Anti-therapeutic Antibodies (ATA) to Atezolizumab||Day 1 of all cycles (Cycle length = 21 days) and at treatment discontinuation (data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months)|Cohort 2 Safety Evaluable Population. Here, number of participants analyzed = participants for whom ATA samples were available.||percentage of participants|||Number
648063|NCT02108652|Secondary|Minimum Serum Concentration (Cmin) of Atezolizumab||Pre-dose (0 hours) on Day 1 of Cycles 1, 2, 3, 4, 8 (Cycle length = 21 days)|Cohort 2 PK evaluable population. Here, number of participants analyzed = participants who were evaluable for this outcome. “n” = participants who were evaluable at specified timepoint.||mcg/mL||Standard Deviation|Mean
648087|NCT02108223|Secondary|the Number of Oocytes Retrieved|median number of oocytes retrieved per participant|up to 9 month|||oocytes||Standard Deviation|Median
648064|NCT02108652|Secondary|Maximum Serum Concentration (Cmax) of Atezolizumab||Pre-dose (0 hours) and 30 minutes post-dose on Day 1 of Cycle 1 (Cycle length = 21 days)|Cohort 2 pharmacokinetic (PK) evaluable population was defined as participants who received any dose of atezolizumab treatment and had PK data at timepoints that were sufficient to determine PK parameters. Here, number of participants analyzed = participants who were evaluable for this outcome.||microgram(s)/milliliter (mcg/mL)||Standard Deviation|Mean
648065|NCT02108652|Secondary|Percentage of Participants Alive at 1-year||1-year|Cohort 2 ITT Population||percentage of participants||95% Confidence Interval|Number
648066|NCT02108652|Secondary|Overall Survival (OS)|OS was defined as the time from start of treatment to the time of death from any cause on study.|Baseline until death (data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months)|Cohort 2 ITT population||months||95% Confidence Interval|Median
648067|NCT02108652|Secondary|Percentage of Participants Who Died|The percentage of participants who died from any cause was reported.|Baseline until death (data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months)|Cohort 2 ITT population||percentage of participants|||Number
648068|NCT02108652|Secondary|Percentage of Participants With a Confirmed Objective Response of CR or PR as Assessed by the Investigator According RECIST v1.1|Tumor response was assessed by the investigator according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. The percentage of participants with a confirmed objective response of CR or PR was reported. The exact 95% CI was calculated using the Clopper-Pearson method.|Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months)|Cohort 2 objective response-evaluable population.||percentage of participants||95% Confidence Interval|Number
648069|NCT02108652|Secondary|PFS as Assessed by the Investigator According to Modified RECIST|PFS was defined as the time from start of treatment to the first event of death or PD. Tumor response was assessed by the investigator according to modified RECIST. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.|Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months)|Cohort 2 ITT population||months||95% Confidence Interval|Median
648070|NCT02108652|Secondary|Percentage of Participants With Death or Disease Progression as Assessed by the Investigator According to Modified RECIST|Tumor response was assessed by the investigator according to modified RECIST. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The percentage of participants who died or experienced PD was reported.|Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months)|Cohort 2 ITT population||percentage of participants|||Number
648071|NCT02108652|Secondary|PFS as Assessed by the Investigator According to RECIST v1.1|PFS was defined as the time from start of treatment to the first event of death or PD. Tumor response was assessed by the investigator according to RECIST v1.1. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.|Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months)|Cohort 2 ITT population||months||95% Confidence Interval|Median
648072|NCT02108652|Secondary|Percentage of Participants With Death or Disease Progression as Assessed by the Investigator According to RECIST v1.1|Tumor response was assessed by the investigator according to RECIST v1.1. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The percentage of participants who died or experienced PD was reported.|Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months)|Cohort 2 ITT population||percentage of participants|||Number
648073|NCT02108652|Secondary|Progression-Free Survival (PFS) as Assessed by the IRF According to RECIST v1.1|PFS was defined as the time from start of treatment to the first event of death or PD. Tumor response was assessed by the IRF according to RECIST v1.1. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.|Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months)|Cohort 2 ITT population||months||95% Confidence Interval|Median
648074|NCT02108652|Secondary|Percentage of Participants With Death or Disease Progression as Assessed by the IRF According to RECIST v1.1|Tumor response was assessed by the IRF according to RECIST v1.1. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The percentage of participants who died or experienced PD was reported.|Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months)|Cohort 2 ITT population||percentage of participants|||Number
648548|NCT02100514|Secondary|Absolute Change From Baseline in Fasting Total Cholesterol (TC) at Week 12||Baseline, Week 12|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."||mg/dL||Standard Deviation|Mean
648075|NCT02108652|Secondary|DOR as Assessed by the Investigator According to Modified RECIST|DOR was defined as the time from the initial occurrence of documented CR or PR (whichever occurred first) until documented disease progression or death due to any cause on study, whichever occurred first. Tumor response was assessed by the investigator according to modified RECIST. CR was defined as disappearance of all target and non-target lesions and no new measurable or unmeasurable lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to Baseline sum LD. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR.|Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months)|Cohort 2 objective response-evaluable population. Here, number of participants analyzed = participants who were evaluable for this outcome.||months||Full Range|Median
648076|NCT02108652|Secondary|DOR as Assessed by the Investigator According to RECIST v1.1|DOR was defined as the time from the initial occurrence of documented CR or PR (whichever occurred first) until documented disease progression or death due to any cause on study, whichever occurred first. Tumor response was assessed by the investigator according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to Baseline sum LD. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR.|Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months)|Cohort 2 objective response-evaluable population. Here, number of participants analyzed = participants who were evaluable for this outcome.||months||Full Range|Median
648077|NCT02108652|Secondary|Duration of Response (DOR) as Assessed by the IRF According to RECIST v1.1|DOR was defined as the time from the initial occurrence of documented CR or PR (whichever occurred first) until documented disease progression or death due to any cause on study, whichever occurred first. Tumor response was assessed by the IRF according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to Baseline sum LD. Disease progression or progressive disease (PD) was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR.|Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months)|Cohort 2 objective response-evaluable population. Here, number of participants analyzed = participants who were evaluable for this outcome.||months||Full Range|Median
648078|NCT02108652|Primary|Percentage of Participants With a Confirmed Objective Response of CR or PR as Assessed by the Investigator According Modified RECIST|Tumor response was assessed by the investigator according to modified RECIST. CR was defined as disappearance of all target and non-target lesions and no new measurable or unmeasurable lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. The percentage of participants with a confirmed objective response of CR or PR was reported. The exact 95% CI was calculated using the Clopper-Pearson method.|Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months)|Cohort 2 objective response-evaluable population.||percentage of participants||95% Confidence Interval|Number
648079|NCT02108652|Primary|Percentage of Participants With a Confirmed Objective Response of Complete Response (CR) or Partial Response (PR) as Assessed by the Independent Review Facility (IRF) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)|Tumor response was assessed by the IRF according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeters (mm). PR was defined as greater than or equal to (≥) 30 percent (%) decrease in sum of longest diameter (LD) of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. The percentage of participants with a confirmed objective response of CR or PR was reported. The exact 95% confidence interval (CI) was calculated using the Clopper-Pearson method.|Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months)|Cohort 2 objective response-evaluable population included Intent-to-treat (ITT) participants who had measurable disease per RECIST v1.1 at baseline. Cohort 2 ITT population included all participants from Cohort 2 who received any amount of study drug.||percentage of participants||95% Confidence Interval|Number
648080|NCT02108288|Secondary|Tmax of Latanoprost Acid||Day 1 and Day 7|||min||Full Range|Median
648081|NCT02108288|Secondary|Tmax of Carteolol||Day 1 and Day 7|||h||Full Range|Median
648082|NCT02108288|Primary|Cmax of Latanoprost Acid||Day 1 and Day 7|||pg/mL||Standard Deviation|Mean
648083|NCT02108288|Primary|Cmax of Carteolol||Day 1 and Day 7|||ng/mL||Standard Deviation|Mean
648084|NCT02108223|Secondary|Implantation Rates|Implantation rate is the percentage of embryos which successfully undergo implantation|up to 9 months|||percentage of embryo implantation|||Number
648088|NCT02108223|Primary|Pregnancy Rate|percentage of participants with a pregnancy (a b-HCG determination was obtained and considered positive if the value was greater than 10 mIU/ml)|Up to 9 month|In Group 1, transfer procedure could not be performed one patient. In Group 2, the cycle was cancelled in two patients. Oocyte could not be obtained in one patient during OPU. In other 2 patients, transfer couldn’t be done. In Group 3 transfer procedure could not be performed in one patient. The pregnancy rates per embryo transfer were calculated.||percentage of pregnant participants|||Number
648089|NCT02108171|Secondary|Perioperative Hypertonsion Episodes|Hypertension was defined as systolic blood pressure (SBP) increased 130% of the pre-operative value for more than 1 min.|1 day|||participant|||Number
648090|NCT02108171|Secondary|Perioperative Hypotension Episodes|Hypotension was defined as systolic blood pressure (SBP) decreased more than 30% of the pre-operative value for more than 1 min.|1 day|||participant|||Number
648091|NCT02108171|Secondary|Perioperative Tachycardia Episodes|Tachycardia was defined as heart rate (HR) >100 bpm for more than 10 s.|1 day|||participant|||Number
648092|NCT02108171|Secondary|Perioperative Bradycardia Episodes|Bradycardia was defined as heart rate (HR) <45 bpm for more than 10 s.|1 day|||participant|||Number
648093|NCT02108171|Secondary|Number of Participants With Satisfaction Score <2|"Patient satisfaction scores using a 3-point satisfaction score (1 = highly satisfactory, 2 = acceptable, and 3 = unacceptable) were collected when patients were discharged from the post-anesthesia care unit (PACU).
Satisfaction score <2 was considered to be better for the patient"|1 day|||participant|||Number
648094|NCT02108171|Secondary|Systolic Blood Pressure（SBP）of Patients Receiving Intranasal Placebo or Dexmedetomidine|Systolic blood pressure（SBP）of Patients Receiving Intranasal Placebo or Dexmedetomidine.|1 day|||mmHg||Standard Deviation|Mean
648095|NCT02108171|Secondary|Anxiety Score of Patients Receiving Intranasal Placebo or Dexmedetomidine|"4-point anxiety score:
= combative
= anxious
= calm
= amiable. Anxiety score >2 was considered to be better for the preoperative patients."|1 day|||units on a scale||Inter-Quartile Range|Median
648096|NCT02108171|Other Pre-specified|Visual Analogue Scale (VAS) in the Dexmedetomidine (DEX) Group|An investigator who was blinded from the grouping asked the patients to mark their pain level on a 0-100 visual analogue scale (VAS). A VAS higher than 50 was considered a worse outcome and need to be treated with intravenous 40 mg of parecoxib.|1 day|||units on a scale|||Number
648097|NCT02108171|Other Pre-specified|Visual Analogue Scale (VAS) in the Placebo Group|An investigator who was blinded from the grouping asked the patients to mark their pain level on a 0-100 visual analogue scale (VAS). A VAS higher than 50 was considered a worse outcome and need to be treated with intravenous 40 mg of parecoxib.|1 day|||units on a scale|||Number
648098|NCT02108171|Other Pre-specified|Patients With Intra-operative Awareness in Two Groups|Patients With intra-operative awareness in Two Groups. patients receiving intranasal placebo or dexmedetomidine|1 day|||participants|||Number
648099|NCT02108171|Other Pre-specified|Patients With Postoperative Shivering in Two Groups|Patients With postoperative shivering in Two Groups. the occurrence of postoperative shivering|1 day|||participants|||Number
648100|NCT02108171|Other Pre-specified|Patients With Postoperative Vomiting in Two Groups|Patients With postoperative vomiting in Two Groups. Nausea or vomiting was treated with 4 mg of intravenous ondansetron.|1 day|||participants|||Number
648101|NCT02108171|Other Pre-specified|Patients With Postoperative Nausea in Two Groups|Patients With postoperative nausea in Two Groups. Nausea or vomiting was treated with 4 mg of intravenous ondansetron.|1 day|||participants|||Number
648102|NCT02108171|Other Pre-specified|Number of Participants With VAS >50|Patients with postoperative analgesia in two groups. analgesic requests within 2 h after extubation were recorded. An investigator who was blinded from the grouping asked the patients to mark their pain level on a 0-100 visual analogue scale (VAS). A VAS higher than 50 was considered a worse outcome and need to be treated with intravenous 40 mg of parecoxib.|1 day|||Number of Participants with VAS >50|||Number
648103|NCT02108171|Other Pre-specified|HR in the Dexmedetomidine Group at Pre-induction|HR in the dexmedetomidine group at pre-induction. HR was monitored by fiber-optic pulse oximetry during patient transfer from the ward to the operating room|1 day|||bpm|||Number
648104|NCT02108171|Other Pre-specified|HR in the Placebo Group at Pre-induction|HR in the placebo group at pre-induction. HR was monitored by fiber-optic pulse oximetry during patient transfer from the ward to the operating room|1 day|||bpm|||Number
648105|NCT02108171|Other Pre-specified|HR in the Dexmedetomidine Group Before Intranasal Drugs|HR in the dexmedetomidine group Before Intranasal Drugs . HR was monitored by fiber-optic pulse oximetry during patient transfer from the ward to the operating room|1 day|||bpm|||Number
648106|NCT02108171|Other Pre-specified|HR in the Placebo Group Before Intranasal Drugs|HR in the placebo group Before Intranasal Drugs HR was monitored by fiber-optic pulse oximetry during patient transfer from the ward to the operating room|1 day|||bpm|||Number
648107|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Remifentanil After Intranasal Dexmedetomidine at Extubation|"Predicted effect-site concentrations of remifentanil after intranasal dexmedetomidine at extubation.
Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator"|1 day|||ng/ml|||Number
648108|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Remifentanil After Intranasal Placebo at Extubation|"Predicted effect-site concentrations of remifentanil after intranasal placebo at extubation.
Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator"|1 day|||ng/ml|||Number
648120|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Propofol After Intranasal Placebo at Extubation|"Predicted effect-site concentrations of propofol after intranasal placebo at extubation.
Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery."|1 day|||µg/ml|||Number
648109|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Remifentanil After Intranasal Dexmedetomidine at Emergence|"Predicted effect-site concentrations of remifentanil after intranasal dexmedetomidine at emergence.
Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator"|1 day|||ng/ml|||Number
648110|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Remifentanil After Intranasal Placebo at Emergence|"Predicted effect-site concentrations of remifentanil after intranasal placebo at emergence.
Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator"|1 day|||ng/ml|||Number
648111|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Remifentanil After Intranasal Dexmedetomidine at Return of Spontaneous Breathing|"Predicted effect-site concentrations of remifentanil after intranasal dexmedetomidine at return of spontaneous breathing.
Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator"|1 day|||ng/ml|||Number
648112|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Remifentanil After Intranasal Placebo at Return of Spontaneous Breathing|"Predicted effect-site concentrations of remifentanil after intranasal placebo at return of spontaneous breathing.
Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator"|1 day|||ng/ml|||Number
648113|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Remifentanil After Intranasal Dexmedetomidine on Removal of Operative Laryngoscope|"Predicted effect-site concentrations of remifentanil after intranasal dexmedetomidine on removal of operative laryngoscope.
Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator"|1 day|||ng/ml|||Number
648114|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Remifentanil After Intranasal Placebo on Removal of Operative Laryngoscope|"Predicted effect-site concentrations of remifentanil after intranasal placebo on removal of operative laryngoscope.
Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator"|1 day|||ng/ml|||Number
648115|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Remifentanil After Intranasal Dexmedetomidine Before Inserting Operative Laryngoscope|"Predicted effect-site concentrations of remifentanil after intranasal dexmedetomidine before inserting operative laryngoscope.
Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator"|1 day|||ng/ml|||Number
648116|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Remifentanil After Intranasal Placebo Before Inserting Operative Laryngoscope|"Predicted effect-site concentrations of remifentanil after intranasal placebo before inserting operative laryngoscope.
Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator"|1 day|||ng/ml|||Number
648117|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Remifentanil After Intranasal Dexmedetomidine at Tracheal Intubation|"Predicted effect-site concentrations of remifentanil after intranasal dexmedetomidine at tracheal intubation.
Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator"|1 day|||ng/ml|||Number
648118|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Remifentanil After Intranasal Placebo at Tracheal Intubation|"Predicted effect-site concentrations of remifentanil after intranasal placebo at tracheal intubation.
Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml–1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg–1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator"|1 day|||ng/ml|||Number
648119|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Propofol After Intranasal Dexmedetomidine at Extubation|"Predicted effect-site concentrations of propofol after intranasal dexmedetomidine at extubation.
Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery."|1 day|||µg/ml|||Number
648121|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Propofol After Intranasal Dexmedetomidine at Emergence|"Predicted effect-site concentrations of propofol after intranasal dexmedetomidine at emergence.
Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery."|1 day|||µg/ml|||Number
648122|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Propofol After Intranasal Placebo at Emergence|"Predicted effect-site concentrations of propofol after intranasal placebo at emergence.
Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery."|1 day|||µg/ml|||Number
648123|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Propofol After Intranasal Dexmedetomidine at Return of Spontaneous Breathing|"Predicted effect-site concentrations of propofol after intranasal dexmedetomidine at return of spontaneous breathing.
Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery."|1 day|||µg/ml|||Number
648124|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Propofol After Intranasal Placebo at Return of Spontaneous Breathing|"Predicted effect-site concentrations of propofol after intranasal placebo at return of spontaneous breathing.
Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery."|1 day|||ug/ml|||Number
648125|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Propofol After Intranasal Dexmedetomidine on Removal of Operative Laryngoscope|"Predicted effect-site concentrations of propofol after intranasal dexmedetomidine on removal of operative laryngoscope.
Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery."|1 day|||µg/ml|||Number
648126|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Propofol After Intranasal Placebo on Removal of Operative Laryngoscope|"Predicted effect-site concentrations of propofol after intranasal placebo on removal of operative laryngoscope.
Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery."|1 day|||µg/ml|||Number
648127|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Propofol After Intranasal Dexmedetomidine Before Inserting Operative Laryngoscope|"Predicted effect-site concentrations of propofol after intranasal dexmedetomidine before inserting operative laryngoscope.
Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery."|1 day|||µg/ml|||Number
648128|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Propofol After Intranasal Placebo Before Inserting Operative Laryngoscope|"Predicted effect-site concentrations of propofol after intranasal placebo before inserting operative laryngoscope.
Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery."|1 day|||µg/ml|||Number
648129|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Propofol After Intranasal Dexmedetomidine at Tracheal Intubation|"Predicted effect-site concentrations of propofol after intranasal dexmedetomidine at tracheal intubation.
Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml–1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml–1 at 2-min intervals to maintain the Narcotrend index between ‘D0’ and ‘E1’ until the end of surgery."|1 day|||µg/ml|||Number
648130|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Propofol After Intranasal Placebo at Tracheal Intubation|"Predicted effect-site concentrations of propofol after intranasal placebo at tracheal intubation.
Propofol was infused intraoperatively to a target-controlled infusion (TCI) plasma concentration of 2.5μg∙ml–1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml–1 at 2-min intervals to maintain the Narcotrend index between ‘D0’ and ‘E1’ until the end of surgery."|1 day|||µg/ml|||Number
648131|NCT02108171|Other Pre-specified|Time to Extubation of Patients Receiving Intranasal Dexmedetomidine|Time to extubation of patients receiving intranasal dexmedetomidine. The time elapsed between stopping anesthetic infusions and extubation|1 day|||minutes|||Number
648132|NCT02108171|Other Pre-specified|Time to Extubation of Patients Receiving Intranasal Placebo|Time to extubation of patients receiving intranasal placebo. The time elapsed between stopping anesthetic infusions and extubation|1 day|||minutes|||Number
648133|NCT02108171|Other Pre-specified|Time to Consciousness of Patients Receiving Intranasal Dexmedetomidine|Time to consciousness of patients receiving intranasal dexmedetomidine. The time elapsed between stopping anesthetic infusions and consciousness.|1 day|||minutes|||Number
648134|NCT02108171|Other Pre-specified|Time to Consciousness of Patients Receiving Intranasal Placebo|Time to consciousness of patients receiving intranasal placebo. The time elapsed between stopping anesthetic infusions and consciousness.|1 day|||minutes|||Number
648135|NCT02108171|Other Pre-specified|Time to Spontaneous Breathing of Patients Receiving Intranasal Dexmedetomidine|Time to spontaneous breathing of patients receiving intranasal dexmedetomidine. The time elapsed between stopping anesthetic infusions and adequate ventilation|1 day|||minutes|||Number
648136|NCT02108171|Other Pre-specified|Time to Spontaneous Breathing of Patients Receiving Intranasal Placebo|Time to spontaneous breathing of patients receiving intranasal placebo. The time elapsed between stopping anesthetic infusions and adequate ventilation|1 day|||minutes|||Number
648137|NCT02108171|Secondary|Number of Participants With Anxiety Score >2|"satisfaction using a 3-point satisfaction score (1 = highly satisfactory, 2 = acceptable, and 3 = unacceptable) anxiety levels using a 4-point anxiety score (1 = combative, 2 = anxious, 3 = calm, and 4 = amiable) were collected before intranasal drugs and at pre-induction.
Anxiety score >2 was considered to be better for the patient."|1 day|||participant|||Number
648138|NCT02108171|Other Pre-specified|Satisfaction Scores of Patients Receiving Intranasal Dexmedetomidine|Satisfaction scores of patients receiving intranasal dexmedetomidine. Satisfaction used a 3-point satisfaction score(1 = highly satisfactory, 2 = acceptable, and 3 = unacceptable).|1 day|||units on a scale|||Number
648139|NCT02108171|Other Pre-specified|Satisfaction Scores of Patients Receiving Intranasal Placebo|Satisfaction scores of patients receiving intranasal placebo. satisfaction was assessed using a 3-point satisfaction score(1 = highly satisfactory, 2 = acceptable, and 3 = unacceptable).|1 day|||units on a scale|||Number
648140|NCT02108171|Other Pre-specified|Anxiety Score of Patients Receiving Intranasal Dexmedetomidine at Pre-induction|"Anxiety score of Patients Receiving Intranasal dexmedetomidine at Pre-induction.
The patients were taught to rate their anxiety levels using a 4-point anxiety score (1 = combative, 2 =anxious, 3 = calm, and 4 = amiable)"|1 day|||units on a scale|||Number
648141|NCT02108171|Other Pre-specified|Anxiety Score of Patients Receiving Intranasal Placebo at Pre-induction|Anxiety score of Patients Receiving Intranasal Placebo at Pre-induction. The patients were taught to rate their anxiety levels using a 4-point anxiety score (1 = combative, 2 =anxious, 3 = calm, and 4 = amiable)|1 day|||units on a scale|||Number
648142|NCT02108171|Other Pre-specified|Anxiety Score of Patients Receiving Intranasal Dexmedetomidine Before Intranasal Drugs|"Anxiety score of Patients Receiving Intranasal dexmedetomidine Before Intranasal Drugs.
The patients were taught to rate their anxiety levels using a 4-point anxiety score (1 = combative, 2 =anxious, 3 = calm, and 4 = amiable)"|1 day|||units on a scale|||Number
648143|NCT02108171|Other Pre-specified|Anxiety Score of Patients Receiving Intranasal Placebo Before Intranasal Drugs|Anxiety score of Patients Receiving Intranasal Placebo Before Intranasal Drugs. The patients were taught to rate their anxiety levels using a 4-point anxiety score (1 = combative, 2 =anxious, 3 = calm, and 4 = amiable)|1 day|||units on a scale|||Number
648144|NCT02108171|Other Pre-specified|Modified OAA/S Score of Patients Receiving Intranasal Dexmedetomidine After Extubation|"Modified OAA/S score of patients receiving intranasal dexmedetomidine after extubation.
Modified Observer's Assessment of Alertness/Sedation Scale (Modified OAA/S score):
6 Appears alert and awake, responds readily to name spoken in normal tone 5 Appears asleep but responds readily to name spoken in normal tone 4 Lethargic response to name spoken in normal tone 3 Responds only after name is called loudly or repeatedly 2 Responds only after mild prodding or shaking
1 Does not respond to mild prodding or shaking 0 Does not respond to noxious stimulus"|1 day|||units on a scale|||Number
648145|NCT02108171|Other Pre-specified|Modified OAA/S Score of Patients Receiving Intranasal Placebo After Extubation|"Modified OAA/S score of patients receiving intranasal placebo After extubation. Modified Observer's Assessment of Alertness/Sedation Scale (Modified OAA/S score) 6 Appears alert and awake, responds readily to name spoken in normal tone 5 Appears asleep but responds readily to name spoken in normal tone 4 Lethargic response to name spoken in normal tone 3 Responds only after name is called loudly or repeatedly 2 Responds only after mild prodding or shaking
1 Does not respond to mild prodding or shaking 0 Does not respond to noxious stimulus"|1 day|||units on a scale|||Number
648146|NCT02108171|Other Pre-specified|Modified OAA/S Score of Patients Receiving Intranasal Dexmedetomidine at Pre-induction|"Modified OAA/S score of patients receiving intranasal dexmedetomidine at Pre-induction.
Modified Observer's Assessment of Alertness/Sedation Scale (Modified OAA/S score):
6 Appears alert and awake, responds readily to name spoken in normal tone 5 Appears asleep but responds readily to name spoken in normal tone 4 Lethargic response to name spoken in normal tone 3 Responds only after name is called loudly or repeatedly 2 Responds only after mild prodding or shaking
1 Does not respond to mild prodding or shaking 0 Does not respond to noxious stimulus"|1 day|||units on a scale|||Number
648147|NCT02108171|Other Pre-specified|Modified OAA/S Score of Patients Receiving Intranasal Placebo at Pre-induction|"Modified OAA/S score of patients receiving intranasal placebo at Pre-induction.
Modified Observer's Assessment of Alertness/Sedation Scale (Modified OAA/S score):
6 Appears alert and awake, responds readily to name spoken in normal tone 5 Appears asleep but responds readily to name spoken in normal tone 4 Lethargic response to name spoken in normal tone 3 Responds only after name is called loudly or repeatedly 2 Responds only after mild prodding or shaking
1 Does not respond to mild prodding or shaking 0 Does not respond to noxious stimulus"|1 day|||units on a scale|||Number
648148|NCT02108171|Other Pre-specified|Modified OAA/S Score of Patients Receiving Intranasal Dexmedetomidine Before Intranasal Drugs|"Modified OAA/S score of patients receiving intranasal dexmedetomidine Before intranasal drugs Modified Observer’s Assessment of Alertness/Sedation Scale (Modified OAA/S score) 6 Appears alert and awake, responds readily to name spoken in normal tone 5 Appears asleep but responds readily to name spoken in normal tone 4 Lethargic response to name spoken in normal tone 3 Responds only after name is called loudly or repeatedly 2 Responds only after mild prodding or shaking
1 Does not respond to mild prodding or shaking 0 Does not respond to noxious stimulus"|1 day|||units on a scale|||Number
648149|NCT02108171|Other Pre-specified|Modified OAA/S Score of Patients Receiving Intranasal Placebo Before Intranasal Drugs|"Modified OAA/S score of patients receiving intranasal placebo Before intranasal drugs Modified Observer’s Assessment of Alertness/Sedation Scale (Modified OAA/S score) 6 Appears alert and awake, responds readily to name spoken in normal tone 5 Appears asleep but responds readily to name spoken in normal tone 4 Lethargic response to name spoken in normal tone 3 Responds only after name is called loudly or repeatedly 2 Responds only after mild prodding or shaking
1 Does not respond to mild prodding or shaking 0 Does not respond to noxious stimulus"|1 day|||units on a scale|||Number
648150|NCT02108171|Other Pre-specified|Duration of Surgery of Patients Receiving Intranasal Dexmedetomidine|Duration of surgery of patients receiving intranasal dexmedetomidine. Duration from surgery beginning to anesthesia ending|1 day|||minutes|||Number
648151|NCT02108171|Other Pre-specified|Duration of Surgery of Patients Receiving Intranasal Placebo|Duration of surgery of patients receiving intranasal placebo Duration from surgery beginning to anesthesia ending|1 day|||minutes|||Number
648152|NCT02108171|Other Pre-specified|Duration of Anesthesia of Patients Receiving Intranasal Dexmedetomidine|Duration of anesthesia of patients receiving intranasal dexmedetomidine Duration from anesthesia intubation to anesthesia ending|1 day|||minutes|||Number
648156|NCT02108171|Other Pre-specified|Duration From Intranasal Drug Administration to Arrival at Operating Room of Patients Receiving Intranasal Dexmedetomidine|Duration From Intranasal Drug Administration to Arrival at Operating Room of Patients Receiving Intranasal dexmedetomidine surgical data of patients receiving intranasal dexmedetomidine|1 day|||minutes|||Number
648157|NCT02108171|Other Pre-specified|Duration From Intranasal Drug Administration to Arrival at Operating Room of Patients Receiving Intranasal Placebo|Duration from intranasal drug administration to arrival at operating room of patients receiving intranasal placebo surgical data of patients receiving intranasal placebo|1 day|||minutes|||Number
648158|NCT02108171|Other Pre-specified|Baseline Characteristics (ASA Status) of Patients Receiving Intranasal Placebo or Dexmedetomidine|"American Society of Anesthesiologists (ASA) status of patients receiving intranasal placebo or dexmedetomidine.
ASA I: No organic, physiologic, biochemical or psychiatric disturbance ASA II: A patient with mild systemic disease that results in no functional limitation.
ASA III: A patient with severe systemic disease that results in functional impairment.
ASA IV: Severe systemic disease that is a constant threat to life. ASA V: Moribund condition in a patient who is not expected to survive with or without the operation.
ASA VI: Declared brain death patient whose organs are being harvested for transplantation."|1 day|||participant|||Number
648159|NCT02108171|Other Pre-specified|Baseline Characteristics (Sex)of Patients Receiving Intranasal Placebo or Dexmedetomidine|Baseline characteristics (sex)of patients receiving intranasal placebo or dexmedetomidine The sex of 81 adult patients receiving intranasal placebo or dexmedetomidine|1 day|||participants|||Number
648160|NCT02108171|Other Pre-specified|Baseline Characteristic Data (Height) of Patients Receiving Intranasal Dexmedetomidine|Baseline characteristic data of patients receiving intranasal dexmedetomidine The heights of 40 adult patients receiving intranasal placebo|1 day|||cm|||Number
648161|NCT02108171|Other Pre-specified|Baseline Characteristic Data (Height) of Patients Receiving Intranasal Placebo|Baseline characteristic data of patients receiving intranasal placebo The heights of 41 adult patients receiving intranasal placebo|1 day|||cm|||Number
648162|NCT02108171|Other Pre-specified|Baseline Characteristic Data (Weight) of Patients Receiving Intranasal Dexmedetomidine|Baseline characteristic data of patients receiving intranasal dexmedetomidine The weights of 40 adult patients receiving intranasal dexmedetomidine|1 day|||kg|||Number
648163|NCT02108171|Other Pre-specified|Baseline Characteristic Data (Weight) of Patients Receiving Intranasal Placebo|Baseline characteristic data of patients receiving intranasal placebo The weights of 41 adult patients receiving intranasal placebo|1 day|||kg|||Number
648164|NCT02108171|Secondary|Heart Rate (HR) of Patients Receiving Intranasal Placebo or Dexmedetomidine|Heart rate (HR) of patients receiving intranasal placebo or dexmedetomidine. HR was monitored in the study.|1 day|||bpm||Standard Deviation|Mean
648165|NCT02108171|Secondary|Modified OAA/S Scores of Patients Receiving Intranasal Placebo or Dexmedetomidine|"Modified Observer’s Assessment of Alertness/Sedation scale (OAA/S) scores and 4 point anxiety score of patients receiving intranasal placebo or dexmedetomidine.
Modified Observer’s Assessment of Alertness/Sedation Scale:
6 Appears alert and awake, responds readily to name spoken in normal tone 5 Appears asleep but responds readily to name spoken in normal tone 4 Lethargic response to name spoken in normal tone 3 Responds only after name is called loudly or repeatedly 2 Responds only after mild prodding or shaking
1 Does not respond to mild prodding or shaking 0 Does not respond to noxious stimulus."|1 days|||units on a scale||Inter-Quartile Range|Median
648166|NCT02108171|Primary|Extubation Time After Intranasal Dexmedetomidine Premedication|The times from stopping anesthetic infusions to adequate ventilation, consciousness and extubation after intranasal dexmedetomidine or placebo administration|1 days|||min||Standard Deviation|Mean
648167|NCT02107898|Other Pre-specified|Percent Change From Baseline in Calculated LDL-C at Week 52 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 52 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|From Baseline to Week 52|mITT population.||Percent change||Standard Error|Least Squares Mean
648168|NCT02107898|Other Pre-specified|Percent Change From Baseline in Calculated LDL-C at Week 52 - ITT Analysis|Adjusted LS means and standard errors at Week 52 from MMRM model including available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.||Percent change||Standard Error|Least Squares Mean
648169|NCT02107898|Secondary|Percent Change From Baseline in Apo A1 at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Apo A1 ITT population.||percent change||Standard Error|Least Squares Mean
648170|NCT02107898|Secondary|Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|HDL-C ITT population.||percent change||Standard Error|Least Squares Mean
648171|NCT02107898|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.|From Baseline to Week 24|ITT population.||percent change||Standard Error|Mean
648172|NCT02107898|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.|From Baseline to Week 24|ITT population.||percent change||Standard Error|Mean
648173|NCT02107898|Secondary|Percent Change From Baseline in Apo A1 at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline Apo A1 value on- or off-treatment (Apo A1 ITT population).||percent change||Standard Error|Least Squares Mean
648174|NCT02107898|Secondary|Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline HDL-C value on- or off-treatment (HDL-C ITT population).||percent change||Standard Error|Least Squares Mean
648175|NCT02107898|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.|From Baseline to Week 24|ITT population.||percent change||Standard Error|Mean
648176|NCT02107898|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from a multiple imputation approach followed by robust regression model for handling of missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment were included in the imputation model.|From Baseline to Week 24|ITT population.||percent change||Standard Error|Mean
648177|NCT02107898|Secondary|Percentage of Participants Reaching Calculated LDL-C Goal at Week 24 - On-Treatment Analysis|Adjusted percentages at Week 24 were from multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection).|Up to Week 24|mITT population.||percentage of participants|||Number
648178|NCT02107898|Secondary|Percentage of Participants Reaching Calculated LDL-C Goal at Week 24 - ITT Analysis|"Calculated LDL-C goal was defined as:
<100 mg/dL (2.59 mmol/L) for heFH or non-FH participants who had a history of documented congestive heart disease (CHD), or
<120 mg/dL (3.10 mmol/L) for non-FH participants who had a history of documented diseases (ischemic stroke, peripheral artery disease, chronic kidney disease or diabetes) or other risk factors as defined in JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
Adjusted percentages at Week 24 were obtained from multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were included in imputation model."|Up to Week 24|ITT population.||percentage of participants|||Number
648179|NCT02107898|Secondary|Percent Change From Baseline in Total-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Total-C ITT population.||percent change||Standard Error|Least Squares Mean
648180|NCT02107898|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Non-HDL-C ITT population.||percent change||Standard Error|Least Squares Mean
648181|NCT02107898|Secondary|Percent Change From Baseline in Apo B at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Apo B ITT population.||percent change||Standard Error|Least Squares Mean
648182|NCT02107898|Secondary|Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline Total-C value on- or off-treatment (Total-C ITT population).||percent change||Standard Error|Least Squares Mean
648183|NCT02107898|Secondary|Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection).|From Baseline to Week 24|Participants of the mITT population with one baseline and at least one post-baseline non-HDL-C value on-treatment (non-HDL-C mITT population).||percent change||Standard Error|Least Squares Mean
648184|NCT02107898|Secondary|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment (non-HDL-C ITT population).||percent change||Standard Error|Least Squares Mean
648185|NCT02107898|Secondary|Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection).|From Baseline to Week 24|Participants of the mITT population with one baseline and at least one post-baseline Apo-B value on-treatment (Apo B mITT population).||percent change||Standard Error|Least Squares Mean
648186|NCT02107898|Secondary|Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline Apo B value on- or off-treatment (Apo B ITT population).||percent change||Standard Error|Least Squares Mean
648187|NCT02107898|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - On-treatment Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection).|From Baseline to Week 24|mITT population.||percent change||Standard Error|Least Squares Mean
648188|NCT02107898|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|ITT population.||percent change||Standard Error|Least Squares Mean
648189|NCT02107898|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection) (on-treatment analysis).|From Baseline to Week 24|Modified ITT (mITT) population: all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.||percent change||Standard Error|Least Squares Mean
648213|NCT02107313|Primary|Area Under the Concentration-Time Curve (AUC 0-t)||prior to the initial doses on day 1 and 8 and then 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 8,10,12,16, 24, 30, 36, 48 hours post each dose|PK Population, as defined as all participants who received at least one dose of PBT2 and had sufficient samples collected to determine PK parameters.||h*ng/mL||Standard Deviation|Mean
648190|NCT02107898|Primary|Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT Analysis)|Adjusted least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were used in the model (ITT analysis).|From Baseline to Week 24|ITT population: all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment.||percent change||Standard Error|Least Squares Mean
648191|NCT02107599|Secondary|Change in Scan Interpretation Reliability After Application of Quantitation Software|"Evaluate whether the use of quantitation software improves florbetapir (18F) scan interpretation by using the net reclassification index (NRI). The NRI is a prospective measure that quantifies the correctness of upward and downward reclassification or movement of predicted probabilities as a result of adding a new marker. NRI Values >0 indicate an improvement in scan interpretation accuracy and values <0 indicate a decline in scan interpretation accuracy after application of quantitation software.
NRI = [P(up,event)-P(down,event)]-[P(up,nonevent)-P(down,nonevent)] Where P(up,event) = # events up/# events P(down,event) = # events down/# events P(up,nonevent) = # nonevents up/# nonevents P(down,nonevent) = # nonevents down/# nonevents and events: true positive case nonevents: true negative case up: scan change from negative to positive down: scan change from positive to negative
Only the 46 scans with autopsy from A16 are used for this outcome measure."|Scan acquired 50-60 minutes post injection|||Fleiss Kappa||95% Confidence Interval|Number
648192|NCT02107599|Primary|Change in Reader Accuracy After Application of Quantitation Software|"Evaluate whether the use of quantitation software improves florbetapir (18F) scan interpretation by using the net reclassification index (NRI). The NRI is a prospective measure that quantifies the correctness of upward and downward reclassification or movement of predicted probabilities as a result of adding a new marker. NRI Values >0 indicate an improvement in scan interpretation accuracy and values <0 indicate a decline in scan interpretation accuracy after application of quantitation software.
NRI = [P(up,event)-P(down,event)]-[P(up,nonevent)-P(down,nonevent)] Where P(up,event) = # events up/# events P(down,event) = # events down/# events P(up,nonevent) = # nonevents up/# nonevents P(down,nonevent) = # nonevents down/# nonevents and events: true positive case nonevents: true negative case up: scan change from negative to positive down: scan change from positive to negative
Only the 46 scans with autopsy from A16 are used for this outcome measure."|Scan acquired 50-60 minutes post injection|||Net Reclassification Index|||Number
648193|NCT02107482|Secondary|Changes in Target Lesion Pruritus Visual Analog Scale (VAS) at Week 12||12 weeks|||Percent Change in Target Lesion Pruritus||Standard Deviation|Mean
648194|NCT02107482|Secondary|The Percentage of Change in Target Lesion Score||12 weeks|||percentage of change in TLS||Standard Deviation|Mean
648195|NCT02107482|Primary|The Percentage of Lesions With a Clear or Almost Clear Rating (Target Lesion Score of 3 or Less) on Target Lesion Scoring at Week 12||12 weeks|||percentage of lesions changed|||Number
648196|NCT02107339|Secondary|Chronic Persistent Surgical Pain|11-point verbal rating scale (0=no pain, 10=worst pain imaginable)|12 months after surgery||||||
648197|NCT02107339|Secondary|Chronic Persistent Surgical Pain|11-point verbal rating scale (0=no pain, 10=worst pain imaginable)|6 months after surgery||||||
648198|NCT02107339|Secondary|Chronic Persistent Surgical Pain|11-point verbal rating scale (0=no pain, 10=worst pain imaginable)|3 months after surgery||||||
648199|NCT02107339|Secondary|Chronic Persistent Surgical Pain|11-point verbal rating scale (0=no pain, 10=worst pain imaginable)|One month after surgery||||||
648200|NCT02107339|Secondary|Patient Satisfaction Scores|Patient satisfaction with overall pain management will be determined using a 101-point verbal rating scale (0=highly dissatisfied (worst), 100=highly satisfied (best))|Postoperative day 3|||units on a scale||Inter-Quartile Range|Median
648201|NCT02107339|Secondary|Patient Satisfaction Scores|Patient satisfaction with overall pain management will be determined using a 101-point verbal rating scale (0=highly dissatisfied (worst), 100=highly satisfied (best))|postoperative day 2|||units on a scale||Inter-Quartile Range|Median
648202|NCT02107339|Secondary|Patient Satisfaction Scores|Patient satisfaction with overall pain management will be determined using a 101-point verbal rating scale (0=highly dissatisfied (worst), 100=highly satisfied (best))|Postopertive day 1|||units on a scale||Inter-Quartile Range|Median
648203|NCT02107339|Secondary|Pain Scores Postoperative Day 3|11-point verbal rating scale (0=no pain, 10=worst pain imaginable)|Pain scores 72 hours after PACU admission|||units on a scale||Inter-Quartile Range|Median
648204|NCT02107339|Secondary|Pain Scores on Postoperative Day 2|11-point verbal rating scale (0=no pain, 10=worst pain imaginable)|Pain scores 48 hours after PACU admission|||units on a scale||Inter-Quartile Range|Median
648205|NCT02107339|Secondary|Pain Scores on Postoperative Day One|11-point verbal rating scale (0=no pain, 10=worst pain imaginable)|Pain scores one day after PACU admission|||units on a scale||Inter-Quartile Range|Median
648206|NCT02107339|Secondary|Pain Scores 2 Hours After PACU Arrival|11-point verbal rating scale (0=no pain, 10=worst pain imaginable)|Pain scores at 120 minutes after PACU admission|||units on a scale||Inter-Quartile Range|Median
648207|NCT02107339|Secondary|Pain Scores 1 Hour After PACU Arrival|11-point verbal rating scale (0=no pain, 10=worst pain imaginable)|Pain scores at 60 minutes after PACU admission|||units on a scale||Inter-Quartile Range|Median
648208|NCT02107339|Secondary|Pain Scores Postanesthesia Care Unit (PACU) Arrival|11-point verbal rating scale (0=no pain, 10=worst pain imaginable)|First 5 minutes after PACU arrival|||units on a scale||Inter-Quartile Range|Median
648209|NCT02107339|Secondary|Hydromorphone Use Third 24 Hours||48-72 hours after surgery|||milligrams||Inter-Quartile Range|Median
648210|NCT02107339|Secondary|Hydromorphone Use Second 24 Hours||24-48 hours after surgery|||milligrams||Inter-Quartile Range|Median
648211|NCT02107339|Primary|Hydromorphone Use at 24 Hours||Use of hydromorphone at 24 hours|||milligrams||Inter-Quartile Range|Median
648212|NCT02107313|Secondary|Safety and Tolerability of PBT2 in Healthy Volunteers Measured by the Number of Participants Reporting at Least One Treatment Emergent Adverse Events||Up to 15 days after the first dose of PBT2|Safety Population, as defined as all participants who received at least one dose of study drug||participants|||Number
648254|NCT02107014|Primary|Change in MIG From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].|||pg/mL||95% Confidence Interval|Median
648214|NCT02107274|Secondary|Spirometric Values: Forced Vital Capacity (FVC)|Pulmonary function testing using a spirometer will be carried out at visits 3, 6 and 8 inclusive. All testing should be done in the sitting position, except for obese patients, who commonly obtain deeper inspiration when tested in the standing position. Subjects should avoid the following prior to lung function testing: Smoking within 1 hour of testing Consuming alcohol within 4 hours of testing Performing vigorous exercise within 30 minutes of testing Wearing restrictive clothing around the chest or abdomen Eating a large meal within 2 hours of testing The following medications must be withheld prior to testing, with the minimum time from last dose indicated- short acting beta agonists (6 hours), long acting beta agonists (12 hours), ipratropium bromide (12 hours), antihistamines (12 hours), Iong acting bronchodilator combinations (12 hours)|Visit 3 (Baseline); Visit 6 (Week 12); Visit 8 (Week 24)|||Litres||Standard Deviation|Mean
648215|NCT02107274|Secondary|Spirometry Value; Forced Expiratory Volume at 1 Second (FEV1)|Pulmonary function testing using a spirometer will be carried out at visits 3, 6 and 8 inclusive. All testing should be done in the sitting position, except for obese patients, who commonly obtain deeper inspiration when tested in the standing position. Subjects should avoid the following prior to lung function testing: Smoking within 1 hour of testing Consuming alcohol within 4 hours of testing Performing vigorous exercise within 30 minutes of testing Wearing restrictive clothing around the chest or abdomen Eating a large meal within 2 hours of testing The following medications must be withheld prior to testing, with the minimum time from last dose indicated- short acting beta agonists (6 hours), long acting beta agonists (12 hours), ipratropium bromide (12 hours), antihistamines (12 hours), long acting bronchodilator combinations (12 hours)|Visit 3 (Baseline); Visit 6 (Week 12); Visit 8 (Week 24)|||Litres||Standard Deviation|Mean
648216|NCT02107274|Secondary|Health Status: St George's Respiratory Questionnaire Score|The St. George Respiratory Questionnaire is to be administered at visits 3, 6 and 8 inclusive. It should be administered in a quiet room where the participant can answer the questions without interruption, prior to any other protocol related procedures|Visit 3 (Baseline); Visit 6 (Week 12); Visit 8 (Week 24)|||Units||Standard Deviation|Mean
648217|NCT02107274|Primary|24 Hour Sputum Volume|Each participant must be instructed and enabled to collect 24 hour sputum volumes over the 24 hours prior to visits 3, 6 and 8, inclusive. As this is the primary endpoint of the study, it is critical that 24 hour sputum volumes are measured and recorded accurately, observing the following protocol: The subject should be given a sterile jar to collect the sputum, which has been weighed previously for convenience. Each jar will be labelled with subject name, start and finish time/date The collection should commence on rising in the morning and complete 24 hours later. Ensure that the sputum sample has minimal saliva in the collection Instruct subject to collect all sputum produced spontaneously or after coughing over a single daytime 24 hour period. The sample should come from the lungs and should not be salivary. Encourage subject not to swallow sputum, but to collect. Each 24 hour collection period should be as similar as possible in terms of physiotherapy and exercise regimens|Visit 3 (Baseline); Visit 6 (Week 12); Visit 8 (Week 24)|A total of 90 subjects were recruited. Among them, 78 subjects fulfilled the inclusion criteria and were randomized. Only 68 subjects completed the study and were subjected for analysis. We targeted to recruit 80 subjects and a dropout rate of 20% was anticipated as stated in the protocol.||gram||Standard Deviation|Mean
648218|NCT02107196|Secondary|Evaluation of Rebound Effects|"Comparison between average abdominal pain intensity (worst abdominal pain on a 0 to 10 NRS scale, where 0 corresponds to no pain and 10 corresponds to worst possible pain) and average stool consistency score (the patients reported Bristol Stool Chart score based on a 1 to 7 NRS scale where 1 corresponds to hard stool and 7 corresponds to watery diarrhoea) during the 4-week RW presented as change to baseline.
The analysis only included the patients randomised to ibodutant in the 12-week treatment period and re-randomised to placebo for the 4-week RW period. Baseline was considered as the average abdominal pain intensity/stool consistency in the 2-week Run-in period."|4 weeks|modified RW population: only patients randomised to ibodutant in the 12-week treatment period and re-randomized to placebo for the 4-week RW period (excluding patients from one site, where a potential serious breach of GCP was reported, and another site, where disqualification proceedings against the Investigator were confirmed by FDA).||units on a scale||Standard Deviation|Mean
648219|NCT02107196|Secondary|Weekly Response for Relief of Overall IBS Signs and Symptoms Over 12 Weeks of Treatment in at Least 50% of the Weeks of Treatment (6 Out of 12 Weeks).|"The patient will be considered a weekly responder if she has an IBS degree-of-relief equal to completely relieved/improved or considerably relieved/improved."|12 weeks|The secondary efficacy analysis was performed on the modified ITT population (n=437): all patients included in the ITT population excluding patients from one site, where a potential serious breach of GCP was reported, and from another site, where disqualification proceedings against the Investigator were confirmed by the FDA.||percentage of responders|||Number
648220|NCT02107196|Secondary|Weekly Response for Stool Consistency Over 12 Weeks of Treatment in at Least 50% of the Weeks of Treatment (6 Out of 12 Weeks).|"The patient will be considered a weekly stool consistency responder if she meets the following criterion:
Decrease of at least 50% in the number of days per week with at least one stool that has a consistency of Type 6 or 7 compared with baseline. The patients reported Bristol Stool Chart score based on a 1 to 7 scale where 1 corresponds to hard stool and 7 corresponds to watery diarrhoea."|12 weeks|The secondary efficacy analysis was performed on the modified ITT population (n=437): all patients included in the ITT population excluding patients from one site, where a potential serious breach of GCP was reported, and from another site, where disqualification proceedings against the Investigator were confirmed by the FDA.||percentage of responders|||Number
648221|NCT02107196|Secondary|Weekly Response for Abdominal Pain Intensity Over 12 Weeks of Treatment in at Least 50% of the Weeks of Treatment (6 Out of 12 Weeks).|"The patient will be considered a weekly abdominal pain responder if she meets the following criterion:
Decrease in weekly average of worst abdominal pain score in the past 24 hours of at least 30% compared with baseline."|12 weeks|The secondary efficacy analysis was performed on the modified ITT population (n=437): all patients included in the ITT population excluding patients from one site, where a potential serious breach of GCP was reported, and from another site, where disqualification proceedings against the Investigator were confirmed by the FDA.||percentage of responders|||Number
648255|NCT02107014|Primary|Change in MCP-3 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].|||pg/mL||95% Confidence Interval|Median
648256|NCT02107014|Primary|Change in MCP-1 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].|||pg/mL||95% Confidence Interval|Median
648222|NCT02107196|Primary|Weekly Response for Abdominal Pain Intensity AND Stool Consistency Over 12 Weeks of Treatment in at Least 50% of the Weeks of Treatment (6 Out of 12 Weeks).|"The patient will be considered a weekly responder if she meets both of the following criteria in the same week:
Abdominal pain response: decrease in weekly average of worst abdominal pain score in the past 24 hours of at least 30% compared with baseline;
Stool consistency response: decrease of at least 50% in the number of days per week with at least one stool that has a consistency of Type 6 or 7 compared with baseline. The patients reported Bristol Stoll Chart score based on a 1 to 7 scale where 1 corresponds to hard stool and 7 corresponds to watery diarrhoea."|12 weeks|The primary efficacy analysis was performed on the modified ITT population (n=437): all patients included in the ITT population excluding patients from one site, where a potential serious breach of GCP was reported, and from another site, where disqualification proceedings against the Investigator were confirmed by the FDA.||Percentage of Responders|||Number
648223|NCT02107014|Primary|Change in Overall Fibromyalgia Symptoms From Baseline.|"Visual analog scale (0-100) anchored at no symptoms at 0 and worst possible symptoms at 100. Improvement in overall fibromyalgia symptoms would be indicated by a decrease in the score."|Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].|||units on a scale||Standard Error|Mean
648224|NCT02107014|Primary|Change in Pain From Baseline.|"Visual analog scale (0-100) anchored at no pain at 0 and worst possible pain at 100. Improvement in pain would be indicated by a decrease in the score."|Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].|||units on a scale||Standard Error|Mean
648225|NCT02107014|Primary|Change in IL-22 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].|||pg/mL||95% Confidence Interval|Median
648226|NCT02107014|Primary|Change in FaSL From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].|||pg/mL||95% Confidence Interval|Median
648227|NCT02107014|Primary|Change in GROa From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].|||pg/mL||95% Confidence Interval|Median
648228|NCT02107014|Primary|Change in Resistin From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].|||pg/mL||95% Confidence Interval|Median
648229|NCT02107014|Primary|Change in Leptin From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].|||pg/mL||95% Confidence Interval|Median
648230|NCT02107014|Primary|Change in PAI-1 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].|||pg/mL||95% Confidence Interval|Median
648231|NCT02107014|Primary|Change in PDGF-BB From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].|||pg/mL||95% Confidence Interval|Median
648232|NCT02107014|Primary|Change in ENA-78 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].|||pg/mL||95% Confidence Interval|Median
648233|NCT02107014|Primary|Change in VCAM-1 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].|||pg/mL||95% Confidence Interval|Median
648234|NCT02107014|Primary|Change in ICAM-1 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].|||pg/mL||95% Confidence Interval|Median
648235|NCT02107014|Primary|Change in BDNF From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].|||pg/mL||95% Confidence Interval|Median
648236|NCT02107014|Primary|Change in M-CSF From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].|||pg/mL||95% Confidence Interval|Median
648237|NCT02107014|Primary|Change in FGF-β From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].|||pg/mL||95% Confidence Interval|Median
648238|NCT02107014|Primary|Change in EGF From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].|||pg/mL||95% Confidence Interval|Median
648239|NCT02107014|Primary|Change in NGF From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].|||pg/mL||95% Confidence Interval|Median
648240|NCT02107014|Primary|Change in VEGF From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].|||pg/mL||95% Confidence Interval|Median
648241|NCT02107014|Primary|Change in VEGF-D From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].|||pg/mL||95% Confidence Interval|Median
648242|NCT02107014|Primary|Change in HGF From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].|||pg/mL||95% Confidence Interval|Median
648243|NCT02107014|Primary|Change in SCF From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].|||pg/mL||95% Confidence Interval|Median
648244|NCT02107014|Primary|Change in PIGF-1 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].|||pg/mL||95% Confidence Interval|Median
648245|NCT02107014|Primary|Change in TNF-β From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].|||pg/mL||95% Confidence Interval|Median
648246|NCT02107014|Primary|Change in TNF-α From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].|||pg/mL||95% Confidence Interval|Median
648247|NCT02107014|Primary|Change in IFN-γ From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].|||pg/mL||95% Confidence Interval|Median
648248|NCT02107014|Primary|Change in IFN-β From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].|||pg/mL||95% Confidence Interval|Median
648249|NCT02107014|Primary|Change in IFN-α From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].|||pg/mL||95% Confidence Interval|Median
648250|NCT02107014|Primary|Change in TGF-β From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].|||pg/mL||95% Confidence Interval|Median
648251|NCT02107014|Primary|Change in TGF-α From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].|||pg/mL||95% Confidence Interval|Median
648252|NCT02107014|Primary|Change in CD40L From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].|||pg/mL||95% Confidence Interval|Median
648253|NCT02107014|Primary|Change in TRAIL From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].|||pg/mL||95% Confidence Interval|Median
648290|NCT02106923|Secondary|AUC0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity), for Metformin|Area under the concentration-time curve of metformin in plasma over the time interval from 0 extrapolated to infinity|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration|Pharmacokinetic (PK) set (PKS) which included all subjects of the treated set who provided at least one observation for at least one primary PK endpoint and had no important protocol violations with respect to the statistical evaluation of PK endpoints.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
648291|NCT02106923|Primary|Cmax (Maximum Measured Concentration of the Analyte in Plasma, for Metformin|Maximum measured concentration of metformin in plasma|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration|Pharmacokinetic (PK) set (PKS) which included all subjects of the treated set who provided at least one observation for at least one primary PK endpoint and had no important protocol violations with respect to the statistical evaluation of PK endpoints.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
648292|NCT02106923|Primary|Cmax (Maximum Measured Concentration of the Analyte in Plasma, for Empagliflozin|Maximum measured concentration of empagliflozin in plasma (Cmax).|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration|Pharmacokinetic (PK) set (PKS) which included all subjects of the treated set who provided at least one observation for at least one primary PK endpoint and had no important protocol violations with respect to the statistical evaluation of PK endpoints.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
648293|NCT02106923|Secondary|AUC0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity), for Empagliflozin|Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity).|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration|Pharmacokinetic (PK) set (PKS) which included all subjects of the treated set who provided at least one observation for at least one primary PK endpoint and had no important protocol violations with respect to the statistical evaluation of PK endpoints.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
648294|NCT02106923|Primary|AUC0-tz (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point) for Metformin|Area under the concentration-time curve of metformin in plasma over the time interval from 0 to the last quantifiable data point|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration|Pharmacokinetic (PK) set (PKS) which included all subjects of the treated set who provided at least one observation for at least one primary PK endpoint and had no important protocol violations with respect to the statistical evaluation of PK endpoints.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
648295|NCT02106923|Primary|AUC0-tz (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point), for Empagliflozin|Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz).|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration|Pharmacokinetic (PK) set (PKS) which included all subjects of the treated set who provided at least one observation for at least one primary PK endpoint and had no important protocol violations with respect to the statistical evaluation of PK endpoints.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
648296|NCT02106832|Primary|Time to First Exacerbation Event Within 48 Weeks - Cipro 14 vs. Pooled Placebo|Time to first exacerbation was defined as the time from randomization until the visit at which the first qualifying exacerbation is recorded by the investigator. Exacerbation events are defined as exacerbations with systemic antibiotic use and presence of fever or malaise / fatigue and worsening of at least three signs/symptoms.|Up to Week 48|Full analysis set (FAS) included participants who were randomized.||Days||95.1% Confidence Interval|Median
648297|NCT02106832|Secondary|Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at End of Treatment (Week 44/46)|FEV1 was defined as the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration, expressed in liters at body temperature and ambient pressure saturated with water vapor (BTPS).|Baseline and end of treatment (Week 44/46)|FAS with participants evaluable for this outcome measure.||Liter||Standard Deviation|Mean
648298|NCT02106832|Secondary|Mean Change From Baseline in Patient Reported Outcome Quality of Life Questionnaire for Bronchiectasis (QoL-B) Respiratory Symptoms Domain Score at End of Treatment (Week 44/46)|The QoL-B was a disease-specific questionnaire developed for non-Cystic fibrosis Bronchiectasis. It covers 8 dimensions: physical functioning, role functioning, emotional functioning, social functioning, vitality, treatment burden, health perceptions, and respiratory symptoms. Each dimension was scored separately on a scale of 0 to 100, and higher scores represent better outcomes. For this outcome measure, the respiratory symptoms domain score was reported.|Baseline and end of treatment (Week 44/46)|FAS with participants evaluable for this outcome measure.||Score on a scale||Standard Deviation|Mean
648299|NCT02106832|Secondary|Percentage of Participants With Occurrence of New Pathogens Present at End of Treatment (Week 44/46)|New pathogens were any of the pre-specified organisms not cultured before start of study medication. There was no imputation for participants who discontinued the study prematurely.|End of treatment (Week 44/46)|Full analysis set (FAS) included participants who were randomized.||Percentage of participants|||Number
648314|NCT02106403|Primary|Participant-perceived Cooling Sensation at 15 Min|The cooling sensation was assessed on VAS (0-100 mm, where 0= no cooling and 100= extreme cooling) at 15 min post study product application.|At 15 min after product application|Efficacy analysis was based on intent-to-treat (ITT) population defined as all randomized participants who received the product at least once and provided at least one post product use assessment of efficacy. One participant had one efficacy assessment outside the required time window but was included in ITT population||Score on a scale||Standard Error|Least Squares Mean
648300|NCT02106832|Secondary|Mean Change From Baseline in Patient Reported Outcome Saint George's Respiratory Questionnaire (SGRQ) Symptoms Component Score at End of Treatment (Week 44/46)|The SGRQ was a validated, disease-specific instrument that measures health-related quality of life (HRQoL) in adults with chronic obstructive pulmonary disease (COPD) and asthma and was later validated for use in bronchiectasis. The SGRQ covers 3 dimensions: symptoms, activity and impact on daily life. To determine the outcome, a score ranging from 1 to 100 was calculated for each individual domain and for the total score, and smaller scores indicate better health status. For this outcome measure, the symptoms component score was reported.|Baseline and end of treatment (Week 44/46)|FAS with participants evaluable for this outcome measure.||Score on a scale||Standard Deviation|Mean
648301|NCT02106832|Secondary|Percentage of Participants With Pathogen Eradication at End of Treatment (Week 44/46)|Pathogen eradication was defined as a negative culture result for all pre-specified pathogens at end of treatment (week 44 or 46 depending on treatment regimen) that were present in the participant at baseline. There was no imputation for participants who discontinued the study prematurely.|End of treatment (Week 44/46)|Full analysis set (FAS) included participants who were randomized.||Percentage of participants|||Number
648302|NCT02106832|Secondary|Number of Participants With Exacerbation Events With Worsening of at Least One Sign/Symptom Over 48 Weeks|For this outcome measure, exacerbation events were defined as exacerbations with systemic antibiotic use and worsening of at least one sign/symptom over 48 weeks.|Up to Week 48|Full analysis set (FAS) included participants who were randomized.||Participants|||Count of Participants
648303|NCT02106832|Secondary|Number of Participants With Exacerbation Events With Worsening of at Least Three Signs/Symptoms Over 48 Weeks|For this outcome measure, exacerbation events were defined as exacerbations with systemic antibiotic use and presence of fever or malaise / fatigue and worsening of at least three signs/symptoms over 48 weeks.|Up to Week 48|Full analysis set (FAS) included participants who were randomized.||Participants|||Count of Participants
648304|NCT02106832|Primary|Time to First Exacerbation Event Within 48 Weeks - Cipro 28 vs. Pooled Placebo|Time to first exacerbation was defined as the time from randomization until the visit at which the first qualifying exacerbation is recorded by the investigator. Exacerbation events are defined as exacerbations with systemic antibiotic use and presence of fever or malaise / fatigue and worsening of at least three signs/symptoms.|Up to Week 48|Full analysis set (FAS) included participants who were randomized.||Days||99.9% Confidence Interval|Median
648305|NCT02106728|Secondary|Change in Caregiver Functioning|EDSIS measures impact of ED.Subscales:Nutrition:0-32;Guilt:0-20;Dysregulated Behaviour:0-28;Social Isolation:0-16;Total: 0-96.Higher scores mean more negative appraisals of caregiving.Scores are summed.2)FQ measures criticism in families. Subscales:Critical Comments: 10-40;Emotional over-involvement: 10-40;Total:20-80.Higher scores mean higher perceived criticism.Scores are summed.3)SPS measures perceived social support. Attachment:4-16;Social Integration:4-16;Reassurance of Worth:4-16;Reliable Alliance Guidance:4-16;Opportunity for Nurturance:4-16;Total:24-96.Higher scores indicate higher social support.Scores are summed.4)Devaluation of consumers and consumer families measures perceived discrimination and stigma. Two subscales are:devaluation of consumers(8-32);devaluation of consumer’s families (7-28).Higher scores indicate higher levels of perceived discrimination and stigma. Subscales are summed separately.5)BDI, scored from 0-63:higher scores indicate higher levels of depression|Baseline, end of treatment(8 weeks for multi-family therapy/average 10 weeks for supportive family therapy), three months post-treatment|||units on a scale||Standard Deviation|Mean
648306|NCT02106728|Primary|Change in Weight|Change in weight is measured to gauge if there has been a loss, gain, or maintenance.|Baseline, End of treatment(8 weeks for multi-family therapy/average 10 weeks for supportive family therapy)|||pounds||Standard Deviation|Mean
648307|NCT02106728|Primary|Dropout|3 months post enrollment in the study, participant's program completion is measures (completed, withdrawn, dropped out)|3 months post enrollment|||participants|||Number
648308|NCT02106494|Secondary|Rate of No Emetic Episodes|To determine the effect of APF530 on the rate of no emetic episodes (vomiting or retching) in the overall phase (0 to 120 hours) of CINV.|0 - 120 Hours|Modified Intent to Treat (mITT) - all subjects in the randomized population who receive study drug and a HEC regimen and have post-baseline efficacy data.||percentage of participants|||Number
648309|NCT02106494|Secondary|Overall Complete Control Rate|To determine the effect of APF530 on complete control rates defined as no more than mild nausea, no emetic episodes [vomiting or retching], and no use of rescue medications in the overall phase (0 to 120 hours) of CINV.|0 - 120 Hours|Modified Intent to Treat (mITT) - all subjects in the randomized population who receive study drug and a HEC regimen and have post-baseline efficacy data.||percentage of participants|||Number
648310|NCT02106494|Secondary|Delayed Complete Control (CC) Rate|To determine the effect of APF530 on complete control rates defined as no more than mild nausea, no emetic episodes [vomiting or retching], and no use of rescue medications in the delayed phase (24 to 120 hours) of CINV.|24 - 120 Hours|Modified Intent to Treat (mITT) - all subjects in the randomized population who receive study drug and a HEC regimen and have post-baseline efficacy data.||percentage of participants|||Number
648311|NCT02106494|Secondary|Overall Complete Response Rate|To determine the effect of APF530 on complete response rates in the overall phase (0 to 120 hours) of CINV.|0 - 120 Hours|Modified Intent to Treat (mITT) - all subjects in the randomized population who receive study drug and a HEC regimen and have post-baseline efficacy data.||percentage of participants|||Number
648312|NCT02106494|Primary|Delayed Phase Complete Response (CR) Rate|Percentage of Participants with no emesis and no rescue medication in patients receiving HEC in the delayed phase (24 to 120 hours) of CINV.|24 - 120 Hours|Modified Intent to Treat (mITT) - all subjects in the randomized population who receive study drug and a HEC regimen and have post-baseline efficacy data.||percentage of participants|||Number
648313|NCT02106403|Secondary|Overall Sensory Liking of Study Products|Overall sensory liking of the study products was assessed immediately, 3min, 5 min and 15 min after products application. The assessment was done on a 9 point categorical scale where 1= Dislike it extremely, 2= Dislike it very much, 3= Dislike it moderately, 4= Dislike it slightly, 5= Neither like it nor dislike it, 6= Like it slightly, 7= Like it moderately, 8= Like it very much, 9= Like it extremely.|Immediatey, 3 min, 5 min and 15 min after product application|Efficacy analysis was based on intent-to-treat (ITT) population defined as all randomized participants who received the product at least once and provided at least one post product use assessment of efficacy. One participant had one efficacy assessment outside the required time window but was included in ITT population||Score on a scale||Standard Error|Least Squares Mean
648315|NCT02106403|Primary|Participant-perceived Cooling Sensation at 5 Min|The cooling sensation was assessed on VAS (0-100 mm, where 0= no cooling and 100= extreme cooling) at 5 min post study product application.|At 5 min after product application|Efficacy analysis was based on intent-to-treat (ITT) population defined as all randomized participants who received the product at least once and provided at least one post product use assessment of efficacy. One participant had one efficacy assessment outside the required time window but was included in ITT population||Score on a scale||Standard Error|Least Squares Mean
648316|NCT02106403|Primary|Participant-perceived Cooling Sensation at 3 Min|The cooling sensation was assessed on VAS (0-100 mm, where 0= no cooling and 100= extreme cooling) at 3 min post study product application.|At 3 min after product application|Efficacy analysis was based on intent-to-treat (ITT) population defined as all randomized participants who received the product at least once and provided at least one post product use assessment of efficacy. One participant had one efficacy assessment outside the required time window but was included in ITT population||Score on a scale||Standard Error|Least Squares Mean
648317|NCT02106403|Primary|Participant-perceived Cooling Sensation Immediately Post Product Application|The cooling sensation was assessed immediately after the study product application on 100 millimeter (mm) Visual Analogue Scale (VAS) (0-100 mm, where 0= no cooling and 100= extreme cooling).|Immediately after product application|Efficacy analysis was based on intent-to-treat (ITT) population defined as all randomized participants who received the product at least once and provided at least one post product use assessment of efficacy. One participant had one efficacy assessment outside the required time window but was included in ITT population||Score on a scale||Standard Error|Least Squares Mean
648318|NCT02106156|Secondary|Percentage of Participants With the Most Frequent Concomitant Medications|Most frequent concomitant medications were defined as those, which were observed in >1 % of participants.|At Baseline (Day 1)|Only main analysis set had evaluable data for this outcome measure.||percentage of participants|||Number
648319|NCT02106156|Secondary|Duration of Peginterferon Alfa-2a Therapy|Treatment duration was evaluated for participants for whom dates of treatment start and end of therapy were documented.|Up to Week 72|Only treated participants were analyzed for this Outcome Measure. Only participants with evaluable data for this Outcome Measure were included in the analysis.||weeks||Full Range|Median
648320|NCT02106156|Secondary|Percentage Cumulative Dose of Ribavirin Received|Data for the accumulation of the cumulative dose of ribavirin were analyzed and reported as the percentage of the intended dose participants received. Cumulative doses were evaluated for participants for whom dosage data were documented consistently throughout the observational period. If the treatment was ongoing at the study end, the cumulative dose was aggregated for the documented observational period.|Up to Week 96|Only treated participants were analyzed for this Outcome Measure. Only participants with evaluable data for this Outcome Measure were included in the analysis.||percentage of cumulated dose||Full Range|Median
648321|NCT02106156|Secondary|Percentage Cumulative Dose of Peginterferon Alfa-2a Received|Data for the accumulation of the cumulative dose of peginterferon alfa-2a were analyzed and reported as the percentage of the intended dose participants received. Cumulative doses were evaluated for participants for whom dosage data were documented consistently throughout the observational period. If the treatment was ongoing at the study end, the cumulative dose was aggregated for the documented observational period.|Up to Week 96|Only treated participants were analyzed for this Outcome Measure. Only participants with evaluable data for this Outcome Measure were included in the analysis.||percentage of cumulated dose||Full Range|Median
648322|NCT02106156|Primary|Percentage of Participants With Serious Adverse Drug Reactions (SADR)||Up to Week 96|Only treated participants were analyzed for this Outcome Measure. All participants within each analysis set were included in the analysis.||percentage of participants|||Number
648323|NCT02106156|Primary|Percentage of Participants With Sustained Virologic Response (SVR)|SVR is defined as HCV-PCR assay result below limit of detection or viral load ≤50 IU/ml and/or qualitatively negative at least 12 weeks after the end of treatment at follow up. Follow-up visit occurred at 12 to 24 weeks following discontinuation of treatment.|Up to Week 96|Only treated participants were analyzed for this Outcome Measure. All participants within each analysis set were included in the analysis.||percentage of participants|||Number
648324|NCT02106156|Primary|Percentage of Participants With End of Treatment (EOT) Response|EOT Response is defined as HCV-PCR assay result below limit of detection or viral load ≤50 IU/ml and/or qualitatively negative at the end of treatment.|Up to Week 72|Only treated participants were analyzed for this Outcome Measure. All participants within each analysis set were included in the analysis.||percentage of participants|||Number
648325|NCT02106156|Primary|Percentage of Participants With Early Virologic Response (EVR)|EVR is defined as HCV-PCR assay result qualitatively negative and/or decline of viral load of ≥2 log levels and/or viral load ≤50 IU/ml at Week 12.|At Week 12|Only treated participants were analyzed for this Outcome Measure. In each analysis set only those participants were included for whom a valid HCV PCR result was available or who discontinued from treatment before Week 12.||percentage of participants|||Number
648326|NCT02106156|Primary|Percentage of Participants With Rapid Virologic Response (RVR)|RVR is defined as Hepatitis C-Virus (HCV) Polymerase Chain Reaction (PCR) assay result qualitatively negative and/or viral load ≤50 International Units/milliliter (IU/ml) at Week 4.|At Week 4|Only treated participants were analyzed for this Outcome Measure. In each analysis set only those participants were included for whom a valid HCV PCR result was available or who discontinued from treatment before Week 4.||percentage of participants|||Number
648327|NCT02105987|Secondary|Number of Participants With Incidence of Genotypic and Phenotypic Resistance Meeting Confirmed Virologic Withdrawal Criteria Over 24 Weeks|Genotypic and phenotypic testing was conducted for participants who met the confirmed virologic withdrawal criteria, i.e., confirmed HIV-1 RNA >=400 c/mL any time after Day 1. The sample from the “suspected virologic withdrawal criterion” visit was tested for HIV-1 PRO and RT genotype and phenotype and HIV-1 integrase genotype and phenotype (i.e., the first of the two consecutive results >=400 c/mL). At the time of the data cut-off for this Week 24 analysis, no participants met the confirmed virologic withdrawal criteria over 24 weeks; therefore, the virologic analyses were not assessed.|Baseline and up to 24 weeks|Viral Genotypic and Phenotypic Populations: Comprised of all participants in the ITT-E Population with available on-treatment genotypic and phenotypic resistance data, respectively, at the time confirmed virologic withdrawal criterion was met.|||||
648328|NCT02105987|Secondary|Percent Change From Baseline in Cardiovascular Marker Analyte, Glucose at Week 24|Cardiovascular biomarkers were analyzed based on log transformed data. Estimates were from an ANCOVA model adjusting for ART third agent class, interaction of treatment and original ART third agent class, sex, race (white, black or african american, other), and Baseline biomarker level.|Baseline and Week 24|Safety Population. Only participants with a non-missing value at Week 24 are included.||Percent||95% Confidence Interval|Geometric Mean
648329|NCT02105987|Secondary|Percent Change From Baseline in Cardiovascular Marker Analyte, Soluble CD163 at Week 24|Cardiovascular biomarkers were analyzed based on log transformed data. Estimates were from an ANCOVA model adjusting for ART third agent class, interaction of treatment and original ART third agent class, sex, race (white, black or african american, other), and Baseline biomarker level.|Baseline and Week 24|Safety Population. Only participants with a non-missing value at Week 24 are included.||Percent||95% Confidence Interval|Geometric Mean
648330|NCT02105987|Secondary|Percent Change From Baseline in Cardiovascular Marker Analyte, Insulin at Week 24|Cardiovascular biomarkers were analyzed based on log transformed data. Estimates were from an ANCOVA model adjusting for ART third agent class, interaction of treatment and original ART third agent class, sex, race (white, black or african american, other), and Baseline biomarker level.|Baseline and Week 24|Safety Population. Only participants with a non-missing value at Week 24 are included.||Percent||95% Confidence Interval|Geometric Mean
648331|NCT02105987|Secondary|Percent Change From Baseline in Cardiovascular Marker Analyte, Homostat Model Assess of Insulin Resistance at Week 24|Cardiovascular biomarkers were analyzed based on log transformed data. Estimates were from an ANCOVA model adjusting for ART third agent class, interaction of treatment and original ART third agent class, sex, race (white, black or african american, other), and Baseline biomarker level.|Baseline and Week 24|Safety Population. Only participants with a non-missing value at Week 24 are included.||Percent||95% Confidence Interval|Geometric Mean
648332|NCT02105987|Secondary|Percent Change From Baseline in Cardiovascular Marker Analyte, D-Dimer at Week 24|Cardiovascular biomarkers were analyzed based on log transformed data. Estimates were from an ANCOVA model adjusting for ART third agent class, interaction of treatment and original ART third agent class, sex, race (white, black or African American, Other), and Baseline biomarker level.|Baseline and Week 24|Safety Population. Only participants with a non-missing value at Week 24 are included.||Percent||95% Confidence Interval|Geometric Mean
648333|NCT02105987|Secondary|Percent Change From Baseline in Cardiovascular Marker Analyte, C-reactive Protein at Week 24|Cardiovascular biomarkers were analyzed based on log transformed data. Estimates were from an ANCOVA model adjusting for ART third agent class, interaction of treatment and original ART third agent class, sex, race (white, black or African American, Other), and Baseline biomarker level.|Baseline and Week 24|Safety Population. Only participants with a non-missing value at Week 24 are included.||Percent||95% Confidence Interval|Geometric Mean
648334|NCT02105987|Secondary|Percent Change From Baseline in Cardiovascular Marker Analytes at Week 24|Cardiovascular biomarkers were analyzed based on log transformed data. Estimates were from an ANCOVA model adjusting for ART third agent class, interaction of treatment and original ART third agent class, sex, race (white, black or African American, Other), and Baseline biomarker level.|Baseline and Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).||Percent||95% Confidence Interval|Geometric Mean
648335|NCT02105987|Secondary|Percent Change From Baseline in Bone Marker Analytes at Week 24|Outcome Measure Description: Bone biomarkers analytes include bone specific alkaline phosphatase, osteocalcin, procollagen 1 n-terminal propeptide, type I collagen c-telopeptides and were analyzed based on log transformed data. Estimates were from an ANCOVA model adjusting for ART third agent class, interaction of treatment and original ART third agent class, age, sex (male or female), body mass index (BMI) (<25 kilogram per meter [kg/m] or >=25 kg/m), smoking status (never smoked or former smoker or current smoker), Baseline vitamin D (no vitamin D use at Baseline or vitamin D use at Baseline), and Baseline biomarker level.|Baseline and Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).||Percent||95% Confidence Interval|Geometric Mean
648336|NCT02105987|Secondary|Change From Baseline in Urine Albumin/Creatinine Ratio at Week 24|Renal markers included urine albumin/creatinine ratioand summarized based on an OC data set at Week 24. Adjusted mean is the estimated mean change from Baseline in each biomarker at Week 24 in each arm calculated from an ANCOVA analysis of covariance model including the following covariates: treatment, original ART third agent class, interaction of treatment and original ART third agent class, and Baseline biomarker level. Differences are calculated as ABC/DTG/3TC - Current ART regimen.|Baseline and Week 24|Safety Population. Only participants with a non-missing value at Week 24 are included.||Gram per mole (G/mol) creatinine||95% Confidence Interval|Least Squares Mean
648337|NCT02105987|Secondary|Change From Baseline in Urea at Week 24|Renal markers included urea and summarized based on an OC data set at Week 24. Adjusted mean is the estimated mean change from Baseline in each biomarker at Week 24 in each arm calculated from an ANCOVA analysis of covariance model including the following covariates: treatment, original ART third agent class, interaction of treatment and original ART third agent class, and Baseline biomarker level. Differences are calculated as ABC/DTG/3TC - Current ART regimen.|Baseline and Week 24|Safety Population. Only participants with a non-missing value at Week 24 are included.||Millimoles per liter (mmol/L)||95% Confidence Interval|Least Squares Mean
648338|NCT02105987|Secondary|Change From Baseline in GFR From Creatinine Adjusted Using MDRD Enzymatic Equation at Week 24|Renal markers included GFR from creatinine adjusted using modification of diet in renal disease (MDRD) enzymatic equation and summarized based on an OC data set at Week 24. Adjusted mean is the estimated mean change from Baseline in each biomarker at Week 24 in each arm calculated from an ANCOVA analysis of covariance model including the following covariates: treatment, original ART third agent class, interaction of treatment and original ART third agent class, and Baseline biomarker level. Differences are calculated as ABC/DTG/3TC - Current ART regimen.|Baseline and Week 24|Safety Population. Only participants with a non-missing value at Week 24 are included.||mL/second/1.73 meter square||95% Confidence Interval|Least Squares Mean
648445|NCT02103114|Secondary|Incidence of Extracorporeal Membrane Oxygenation (ECMO) Support Within 24 Hours Postoperatively|Study the safety profile of dosing the ATIII by monitoring the incidence of extracorporeal membrane oxygenation (ECMO) support within 24 hours postoperatively.|Baseline (intraoperatively) (Time 1) to Time 7 (Post OP Day 4)|||number|||Number
648339|NCT02105987|Secondary|Change From Baseline in Glomerular Filtration Rate (GFR) From Creatinine Adjusted Using CKD-EPI Equation at Week 24|Renal markers included GFR from creatinine adjusted using chronic kidney disease epidemiology collaboration (CKD-EPI) equation and summarized based on an OC data set at Week 24. Adjusted mean is the estimated mean change from Baseline in each biomarker at Week 24 in each arm calculated from an ANCOVA analysis of covariance model including the following covariates: treatment, original ART third agent class, interaction of treatment and original ART third agent class, and Baseline biomarker level. Differences are calculated as ABC/DTG/3TC - Current ART regimen.|Baseline and Week 24|Safety Population. Only participants with a non-missing value at Week 24 are included.||mL/second||95% Confidence Interval|Least Squares Mean
648340|NCT02105987|Secondary|Change From Baseline in Creatinine at Week 24|Renal markers included creatinine and summarized based on an observed case (OC) data set at Week 24. Adjusted mean is the estimated mean change from Baseline in each biomarker at Week 24 in each arm calculated from an ANCOVA analysis of covariance model including the following covariates: treatment, original ART third agent class, interaction of treatment and original ART third agent class, and Baseline biomarker level. Differences are calculated as ABC/DTG/3TC - Current ART regimen.|Baseline and Week 24|Safety Population. Only participants with a non-missing value at Week 24 are included.||Micromoles per liter (umol/L)||95% Confidence Interval|Least Squares Mean
648341|NCT02105987|Secondary|Change From Baseline in Treatment Satisfaction at Week 4 and Week 24|The HIV treatment satisfaction questionnaire (TSQ) is a 10 item self-reported scale. Individual item scores range from 6 (very satisfied) to 0 (very dissatisfied). The treatment satisfaction total score (range 0-60) is the sum of all the 10 individual items. The general satisfaction/Clinical subscale (range 0-30) is the sum of the 5 clinical items and the lifestyle/ease subscale (range 0-30) is the sum of the remaining 5 lifestyle items. Last observation carried forward (LOCF) were used for the analysis. If a participant had a missing value at Week 24, his previous non-missing available value while on the same treatment was carried forward (ie the Week 4 or withdrawal value is used in the Week 24 summary for participants in the ABC/DTG3TC with missing Week 24 value). Data were analyzed using an ANCOVA model with factors including treatment, Baseline score and stratification factor. Treatment group difference (ABC/DTG/3TC-cART) estimate and 95% CI were presented.|Baseline, Week 4 and Week 24|ITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).||Units on a scale||Standard Error|Mean
648342|NCT02105987|Secondary|Change From Baseline in Fasting Lipids (Total Cholesterol/HDL Cholesterol Ratio) at Week 24|Change from Baseline for fasting lipid parameter total cholesterol/HDL cholesterol ratio. Adjusted mean is the estimated mean change from Baseline at Week 24 in each arm calculated from an analysis of covariance (ANCOVA) model which includes the following covariates: treatment, original ART third agent class, interaction of treatment and original ART 3rd agent, use of lipid modifying agent and Baseline lipid level. Difference is calculated as ABC/DTG/3TC - Current ART regimen. For fasting lipid assessments, an overnight fast is preferred; however, a minimum of a 6-hour fast was acceptable for participants with afternoon appointments.|Baseline and Week 24|Safety Population. Only those participants available at the specified time points.||Ratio||95% Confidence Interval|Least Squares Mean
648343|NCT02105987|Secondary|Change From Baseline in Fasting Lipids (Cholesterol, LDL Cholesterol, HDL Cholesterol, and Triglycerides) at Week 24|Change from Baseline for each fasting lipid parameters included cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides. Adjusted mean is the estimated mean change from Baseline in each parameter at Week 24 in each arm calculated from an analysis of covariance (ANCOVA) model which includes the following covariates: treatment, original ART third agent class, interaction of treatment and original ART 3rd agent, use of lipid modifying agent and Baseline lipid level. Difference is calculated as ABC/DTG/3TC - Current ART regimen. For fasting lipid assessments, an overnight fast is preferred; however, a minimum of a 6-hour fast was acceptable for participants with afternoon appointments.|Baseline and Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).||Millimoles per liter (mmol/L)||95% Confidence Interval|Least Squares Mean
648344|NCT02105987|Secondary|Number of Participants With AEs Leading to Withdrawal Over 24 Weeks|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, based on medical or scientific judgment and all events of possible drug-induced liver injury with hyperbilirubinemia.|Baseline and up to 24 weeks|Safety Population||Participants|||Number
648345|NCT02105987|Secondary|Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to 24 Weeks|The number of participants with maximum post-Baseline emergent hematology toxicities for each grade were summarized by parameter. A toxicity is considered emergent if it develops or increases in intensity from Baseline. For participants who were originally randomized to current ART regimen on Day 1 and then switched to ABC/DTG/3TC on Week 24, Baseline is defined as the last non-missing value from the early switch phase and maximum post-Baseline emergent during the late switch phase was determined relative to this Baseline. The DAIDS table for grading the severity of adult and pediatric AEs was utilized for AE reporting. The DAIDS defined the severity grade as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (potentially life threatening) for each parameter.|Baseline and up to 24 weeks|Safety Population||Participants|||Number
648346|NCT02105987|Secondary|Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to 24 Weeks|The number of participants with maximum post-Baseline emergent chemistry toxicities for each grade were summarized by parameter. A toxicity is considered emergent if it develops or increases in intensity from Baseline. For participants who were originally randomized to current ART regimen on Day 1 and then switched to ABC/DTG/3TC on Week 24, Baseline is defined as the last non-missing value from the early switch phase and maximum post-Baseline emergent during the late switch phase was determined relative to this Baseline. The DAIDS table for grading the severity of adult and pediatric AEs was utilized for AE reporting. The DAIDS defined the severity grade as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (potentially life threatening) for each parameter.|Baseline and up to 24 weeks|Safety Population||Participants|||Number
648446|NCT02103114|Secondary|Length of Post Operative Ventilation in Days|Length of post operative ventilation in days|ICU arrival (Time 5) to Time 7 (Post-Operative Day 4)|||days||Standard Deviation|Mean
648347|NCT02105987|Secondary|Number of Participants With Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) up to 24 Weeks|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, based on medical or scientific judgment and all events of possible drug-induced liver injury with hyperbilirubinemia. The DAIDS table for grading the severity of adult and pediatric AEs was utilized for AE reporting. The DAIDS estimates the severity grade as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (potentially life threatening) for each parameter.|Baseline and up to 24 weeks|Safety Population: all participants who received at least one dose of study drug.||Participants|||Number
648348|NCT02105987|Secondary|Number of Participants in the Virologic Non-response Category From the Snapshot Analysis at Week 24|Virologic non-responders were defined as the participants with a viral load >=50 c/mL in the Week 24 analysis window. Virologic non-response includes participants who had HIV-1 RNA >=50 c/mL, who discontinued for lack of efficacy, who discontinued for other reasons while not suppressed, data in window but not <50 c/mL, and who changed ART regimen at Week 24. Difference is calculated as the proportion on ABC/DTG/3TC - proportion on current ART regimen.|Week 24|ITT-E Population||Participants|||Number
648349|NCT02105987|Secondary|Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at Week 24|Change from Baseline in CD4+ cell counts were assessed at Baseline, Weeks 4, 8, 16 and 24. No imputation for missing data or premature discontinuation was performed and the observed values were used. Baseline value is defined as the last pre-treatment value observed. Change from Baseline was calculated as the observed value minus the Baseline value. The Week 24 data were summarized.|Baseline and Week 24|ITT-E Population. Only participants with non-missing CD4 data at Week 24 are included.||Cells per cubic millimeter (cells/mm^3)||Inter-Quartile Range|Median
648350|NCT02105987|Primary|Number of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <50 Copies Per Milliliter (c/mL) at Week 24 Using the Snapshot Algorithm|The Food and Drug Administration (FDA) snapshot (Missing, Switch or Discontinuation = Failure) algorithm is intended to be primarily a virologic assessment of the endpoint, and as such follows a “virology first” hierarchy. Virologic Success (e.g., <50 c/mL) or virologic failure within an analysis window is typically determined by the last available HIV-1 RNA measurement in that window and in the treatment phase of interest (e.g., Week 24 snapshot outcomes of the early switch phase will not use HIV-1 RNA data from the late switch phase, even if such data is within the Week 24 analysis window). A virologic failure occurs when a participant changes to their ART regimen (e.g., addition of other ARTs to the study-specified regimens, or switches in components of the current ART regimen).|Week 24|Intent-to-Treat Exposed (ITT-E) Population: all participants randomized to ABC/DTG/3TC and receive at least one dose of study drug or randomized to remain on current ART regimen and continue in the study past Day 1.||Participants|||Number
648351|NCT02105974|Secondary|Time to First On-treatment Occurrence of Moderate or Severe COPD Exacerbation|Time to first on-treatment exacerbation was analysed using a Cox proportional hazards model with terms for treatment, reversibility status and percent predicted FEV1 at screening. Exacerbation of COPD is defined by a worsening of symptoms requiring additional treatment. Moderate COPD exacerbation is worsening symptoms of COPD that require treatment with antibiotics and/or systemic corticosteroids. Severe COPD exacerbation is worsening symptoms of COPD that require treatment with in-patient hospitalization. The number of participants with On-Treatment moderate or severe COPD exacerbations are presented.|From the start of double blind study medication until visit 7 (week 12)/Early withdrawal|ITT Population||Participants|||Number
648352|NCT02105974|Secondary|Percentage of Rescue-free 24-hour Periods Over the Entire 12-week Treatment Period|Participants were given daily record cards for daily completion from BL (Week -1) through Week 12 (Visit 7) each morning and prior prior to taking study medication (i.e., single-blind and double-blind study medication), supplemental medication (albuterol [salbutamol] if received). Participants recorded number of occasions supplemental albuterol/salbutamol (MDI and/or nebules) or oxitropium bromide (applicable sites in Japan) used over the previous 24 hours and any medical problems that they had experienced and any medication used to treat these medical problems over the previous 24 hours. Rescue-free 24-hour periods are defined as the 24-hour periods in which the rescue medication (albuterol [salbutamol]) was not used. The percentage of 24-hour periods are summarized for the entire treatment period (12 weeks). Analysis was performed using an analysis of covariance (ANCOVA) model with covariates of treatment, reversibility status (stratum), baseline (week -1) and region.|BL (Week -1), Week 1 to Week 12|ITT Population, all randomized participants who received at least one dose of study medication. Only those participants with at least 1 on treatment rescue medication measurement during the treatment period and without missing covariate information were analyzed.||Percentage of rescue-free periods||Standard Error|Least Squares Mean
648353|NCT02105974|Primary|Mean Change From Baseline (BL) in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) FEV1, on Treatment Day 84|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. Trough FEV1 measurements were taken electronically by spirometry on Days 2, 14, 28, 56 and 84. BL was defined as the mean of the assessments made 30 minutes pre-dose and immediately pre-dose on Treatment Day 1.Trough FEV1 was defined as the mean of the FEV1 values obtained 23 and 24 hours after previous morning's dosing. Change from BL was calculated as the average at each visit minus the BL value. Analysis was performed using a repeated measures model with covariates of treatment, reversibility status (stratum), BL, region, day, day by BL and day by treatment interactions.|Baseline to Day 84|Intent-to-Treat (ITT) Population: all randomized par. who received at least one dose of study medication. Number of par. presented represent those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis||Liter||Standard Error|Least Squares Mean
648371|NCT02105636|Primary|Overall Survival (OS) Rate in All Randomized Participants at Primary Endpoint|The overall survival rate is the probability that a participant will be alive at 3, 6, 9, and 12 months following randomization. Overall survival was defined as the time between the date of randomization and the date of death as a result of any cause. Survival rates were determined via Kaplan-Meier estimates.|Randomization to 3, 6, 9, and 12 months|All randomized participants||percent probability of OS||95% Confidence Interval|Number
648354|NCT02105740|Secondary|Change of Anxiety and Depression in the Hospital Anxiety and Depression Scale (HADS)|Comparison was made through the scores in the Hospital Anxiety and Depression Scale (HADS) to measure the effect of hypnosis in anxiety and depression among the 12 patients of the hypnosis group comparing to the 11 patients of the control group. The scale has 14 items, seven of which are directed to the evaluation of anxiety (HADS-A) and seven to depression (HADS-D). Each item can be scored from zero to three, establishing a score range of 0 to 21 points for each subscale. The better outcome occurs when the mean is lower or equal to 9 for each subscale. The subscales are independent for each result of depression and anxiety.|The study was done with each patient in the first three consecutive weeks after randomization|Were allocated 24 cancer patients, aged between 40-70 years, of both genders, with depression and anxiety score ≥ 9 in Hospital Anxiety and Depression Scale (HADS). One patient of the control group left the research.||units on a scale||Standard Deviation|Mean
648355|NCT02105740|Primary|Change of Pain Score in the Visual Analogue Scale|Comparison was made through the scores in the Visual Analogue Scale (VAS) to measure the effect of hypnosis in pain among the 12 patients of the hypnosis group comparing to the 11 patients of the control group. The scale ranged from 0 to 10 points, without subscales. The better outcome occurs when the mean of the second or the third week decrease 3 points comparing with the first week, or when the mean of the third week decrease 3 points comparing with the second week.|The study was done with each patient in the first three consecutive weeks after randomization|24 cancer patients were allocated. They were aged between 40-70 years, of both genders, with pain scores ≥ 3 measured by Visual Analogue Scale (VAS). One patient of the control group left the research.||units on a scale||Standard Deviation|Mean
648356|NCT02105701|Secondary|Percentage of Participants Achieving Undetectable HCV RNA 24 Weeks After the End of All Treatment (SVR24)|HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.|24 weeks after the end of all study treatment (up to 40 weeks)|The Full Analysis Set (FAS) population consists of all randomized subjects who receive at least one dose of study treatment.||Percentage of participants||95% Confidence Interval|Number
648357|NCT02105701|Primary|Number of Participants Discontinuing Study Treatment Due to an AE|An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 16 weeks|The All Participants as Treated (APaT) population consists of all participants who received at least one dose of study treatment.||Number of participants|||Number
648358|NCT02105701|Primary|Number of Participants Experiencing Adverse Events (AE)|An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 18 weeks|The All Participants as Treated (APaT) population consists of all participants who received at least one dose of study treatment.||Number of participants|||Number
648359|NCT02105701|Primary|Percentage of Participants Achieving Undetectable HCV RNA 12 Weeks After Completing Study Therapy (SVR12)|HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.|12 weeks after the end of all study treatment (up to 28 weeks)|The Full Analysis Set (FAS) population consists of all randomized subjects who receive at least one dose of study treatment.||Percentage of participants||95% Confidence Interval|Number
648406|NCT02104895|Secondary|Excellent Cosmesis|Physician-rated cosmesis, Cosmetic outcome was scored on the four-category Harvard Breast Cosmesis Scale. An excellent cosmetic result score was assigned when the treated breast looked like the contralateral one; a good cosmetic score was assigned for minimal but identifiable radiation effects of the treated breast; a fair score was used if significant radiation effects were readily observable; a poor score was used for severe sequelae due to radiation effects|5 years|||percentage of participants|||Number
648364|NCT02105662|Secondary|Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After the End of All Study Therapy (SVR24)|Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 (High Pure System). The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a lower limit of quantification of 15 IU/mL and a limit of detection of 9.3 IU/mL (in plasma). SVR24 was defined as undetectable (<9.3 IU/mL) HCV RNA at 24 weeks after the end of all study therapy.|24 weeks after end of all therapy (Study Week 36)|FAS; all allocated participants who received at least 1 dose of study treatment.||percentage of participants|||Number
648365|NCT02105662|Primary|Percentage of Participants Discontinuing Study Therapy Due to AEs During the Treatment Period|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol -specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an AE.|Treatment Period (up to 12 weeks)|APaT Population; all participants who received at least one dose of study treatment.||percentage of participants|||Number
648366|NCT02105662|Primary|Percentage of Participants Experiencing Adverse Events (AEs) During the Treatment Period and First 14 Follow-up Days|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol -specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an AE.|Treatment Period plus first 14 follow-up days (up to 14 weeks)|All Participants as Treated (APaT) Population; all participants who received at least one dose of study treatment.||percentage of participants|||Number
648367|NCT02105662|Primary|Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After the End of All Study Therapy (SVR12)|Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 (High Pure System). The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a lower limit of quantification of 15 IU/mL and a limit of detection of 9.3 IU/mL (in plasma). SVR12 was defined as undetectable (<9.3 IU/mL) HCV RNA at 12 weeks after the end of all study therapy.|12 weeks after end of all therapy (Study Week 24)|Full Analysis Set (FAS); all allocated participants who received at least 1 dose of study treatment.||percentage of participants|||Number
648368|NCT02105636|Other Pre-specified|Number of Participants With Death, Study Drug-Related Death, Serious Adverse Events (SAEs), and Study Drug-Related SAEs in All Treated Participants at Primary Endpoint|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug.|Date of first dose of study drug to 30 days post last dose of study drug, approximately 18 months|All Treated Participants: All randomized participants who received at least one dose of study drug||participants|||Number
648369|NCT02105636|Secondary|Objective Response Rate (ORR)|ORR was defined as the proportion of randomized participants who achieved a best response of complete response (CR) or partial response (PR) using the RECIST1.1 criteria as per investigator assessment. Best overall response (BOR) was defined as the best response designation, recorded between the date of randomization and the date of progression, as assessed by the investigator per RECIST 1.1 or the date of subsequent anticancer therapy (including tumor-directed radiotherapy and tumor-directed surgery), whichever occurs first. For participants without evidence of RECIST 1.1 progression or subsequent anticancer therapy, all available response assessments will contribute to the BOR assessment. For participants who continue treatment beyond progression, the BOR was determined based on response assessments up to the time of initial RECIST 1.1 progression.|Randomization to disease progression or study drug is discontinued, whichever occurs first; Approximately 5 years||09/2019||||
648370|NCT02105636|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time between the date of randomization and the first date of documented progression, as determined by the investigator (as per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria), or death due to any cause, whichever occurs first. Participants who die without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants without any on study tumor assessments and did not die were censored on their date of randomization. Participants who received subsequent systemic anti-cancer therapy prior to documented progression were censored at the date of the last tumor assessment prior to the initiation of the new therapy.|Randomization to disease progression or death, whichever occurs first; Approximately 5 years||09/2019||||
648372|NCT02105636|Primary|Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint|Overall survival was defined as the time from randomization to the date of death from any cause. Participants were censored at the date they were last known to be alive and at the date of randomization if they were randomized but had no follow-up. Median OS time was calculated using Kaplan-Meier (KM) method. Hazard ratio (HR) and the corresponding Confidence Interval (CI) were estimated in a stratified Cox proportional hazards model for distribution of OS in each randomized arm. Interim analysis (Primary Endpoint) occurred at 218 deaths.|From date of randomization to date of death, approximately 18 months|All randomized participants.||months||95% Confidence Interval|Median
648373|NCT02105467|Secondary|Percentage of Participants Achieving Sustained Virologic Response at 24 Weeks After the End of Treatment (SVR24)|Hepatitis C Virus RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay. SVR24 was defined as HCV RNA <Lower Limit of Quantitation (<15 IU/mL) 24 weeks after the end of all study therapy.|Week 36 (24 weeks after the end of treatment)|The Full Analysis Set included randomized participants who received at least one dose of study treatment. This outcome measure applied only to the Immediate Treatment group.||Percentage of participants||95% Confidence Interval|Number
648374|NCT02105467|Other Pre-specified|Percentage of Participants Achieving Sustained Virologic Response at 4 Weeks After the End of Treatment (SVR4)|Hepatitis C Virus RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay. SVR4 was defined as HCV RNA <Lower Limit of Quantitation (<15 IU/mL) 4 weeks after the end of all study therapy.|Week 16 (4 weeks after the end of treatment)|The Full Analysis Set included randomized participants who received at least one dose of study treatment. This outcome measure applied only to the Immediate Treatment group.||Percentage of participants||95% Confidence Interval|Number
648375|NCT02105467|Primary|Percentage of Participants Discontinued From Study Treatment Because of an Adverse Event|An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an adverse event.|Up to Week 12 (end of Blinded Treatment)|The All Subjects as Treated population included randomized participants who received at least one dose of study treatment. This outcome measure applied only to the blinded treatment period.||Percentage of participants|||Number
648376|NCT02105467|Primary|Percentage of Participants Experiencing at Least One Adverse Event|An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an adverse event.|Up to Week 14 (14 days after the Blinded Treatment was completed)|The All Subjects as Treated population included randomized participants who received at least one dose of study treatment. This outcome measure applied only to the blinded treatment period.||Percentage of participants|||Number
648377|NCT02105467|Primary|Percentage of Participants Achieving Sustained Virologic Response at 12 Weeks After the End of Treatment (SVR12)|Hepatitis C Virus (HCV) ribonucleic acid (RNA) was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay. SVR12 was defined as HCV RNA <Lower Limit of Quantification (<15 IU/mL) 12 weeks after the end of all study therapy.|Week 24 (12 weeks after the end of treatment)|The Full Analysis Set included randomized participants who received at least one dose of study treatment. This outcome measure applied only to the Immediate Treatment group.||Percentage of participants||95% Confidence Interval|Number
648378|NCT02105454|Secondary|Percentage of Participants Achieving SVR12 by Prior Direct-acting Antiviral (DAA) Therapy|SVR12 is defined as participants having HCV RNA level lower than the LLoQ (<15 IU/mL in plasma), either target detected and unquantifiable or undetectable 12 weeks after the end of all study therapy. Prior DAA therapy regimen included boceprevir, telaprevir, simeprevir, or sofosbuvir taken concomitantly with peginterferon and ribavirin. Below categories specify with our without resistance-associated variants (RAVs) of the hepatitis C virus.|Up to 24 weeks|Per protocol population excludes participants due to important deviations from the protocol that may substantially affect the results of the primary and key secondary efficacy endpoints.||Percentage of participants||95% Confidence Interval|Number
648379|NCT02105454|Primary|Percentage of Participants Discontinuing Study Drug Due to an Adverse Event|Adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product.|Up to 12 weeks|All participants as treated population defined as all participants who received at least one dose of study medication.||Percentage of participants|||Number
648380|NCT02105454|Primary|Percentage of Participants Experiencing Adverse Events|Adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product.|Up to 40 weeks (from Day 1 [post-dose] through 24 [-12/+4] weeks following last dose of study drug)|All participants as treated population defined as all participants who received at least one dose of study medication.||Percentage of participants|||Number
648381|NCT02105454|Primary|Percentage of Participants Achieving Sustained Virologic Response (SVR) at 12 Weeks After the End of All Study Therapy (SVR12)|SVR12 is defined as participants having hepatitis C virus ribonucleic acid (HCV RNA) level lower than the limit of quantification (LLoQ, <15 IU/mL in plasma), either target detected and unquantifiable or undetectable 12 weeks after the end of all study therapy.|Up to 24 weeks|Per protocol population excludes participants due to important deviations from the protocol that may substantially affect the results of the primary and key secondary efficacy endpoints.||Percentage of participants||95% Confidence Interval|Number
648407|NCT02104895|Secondary|Acute Skin Toxicity|"Acute skin toxicity ≥ grade 2, here we report the percentage of participants in each arm who experienced Acute skin toxicity ≥ grade 2"|5 years|||percentage of participants|||Number
648382|NCT02105285|Secondary|Change From Baseline in Intraocular Pressure at Week 8 at 8 Hours After IMP Administration|"Comparison of each group in change from baseline in intraocular pressure at Week 8 at 8 hours after IMP administration.
Arm of a treatment group coming together with latanoprost / carteolol is a reference group． As for Primary Outcome and Secondary Outcome analysis , the OPC-1085EL group was compared only to the carteolol group, not to the latanoprost/carteolol concomitant group.
The number of subjects showed in the Participant Flow comes from all the subjects administered IMP. For efficacy analysis, on the other hand, several subjects were excluded from the analysis according to the statistical analysis plan. For example, subjects without IOP after administration were excluded. In addition, IOP measurement at 8 hours was not mandatory. That is why there are differences between the number in the Participant Flow and Outcome."|Baseline, Week 8 at 8 hours after IMP administration|||mmHg||95% Confidence Interval|Mean
648383|NCT02105285|Secondary|Decrease From Baseline in Intraocular Pressure at Week 8 at 2 Hours After IMP Administration|"Comparison of each group in change from baseline in intraocular pressure at Week 8 at 2 hours after IMP administration.
Arm of a treatment group coming together with latanoprost / carteolol is a reference group． As for Primary Outcome and Secondary Outcome analysis , the OPC-1085EL group was compared only to the carteolol group, not to the latanoprost/carteolol concomitant group.
The number of subjects showed in the Participant Flow comes from all the subjects administered IMP. For efficacy analysis, on the other hand, several subjects were excluded from the analysis according to the statistical analysis plan. For example, subjects without IOP after administration were excluded. In addition, IOP measurement at 8 hours was not mandatory. That is why there are differences between the number in the Participant Flow and Outcome."|Baseline, Week 8 at 2 hours after IMP administration|||mmHg||95% Confidence Interval|Mean
648384|NCT02105285|Secondary|Intraocular Pressure at Week 8 at 8 Hours After IMP Administration|"Comparison of each group in intraocular pressure at Week 8 at 8 hours after IMP administration.
Arm of a treatment group coming together with latanoprost / carteolol is a reference group． As for Primary Outcome and Secondary Outcome analysis , the OPC-1085EL group was compared only to the carteolol group, not to the latanoprost/carteolol concomitant group.
The number of subjects showed in the Participant Flow comes from all the subjects administered IMP. For efficacy analysis, on the other hand, several subjects were excluded from the analysis according to the statistical analysis plan. For example, subjects without IOP after administration were excluded. In addition, IOP measurement at 8 hours was not mandatory. That is why there are differences between the number in the Participant Flow and Outcome."|Week 8 at 8 hours after IMP administration|||mmHg||Standard Error|Mean
648385|NCT02105285|Secondary|Intraocular Pressure at Week 8 at 2 Hours After IMP Administration|"Comparison of each group in intraocular pressure at Week 8 at 2 hours after IMP administration.
Arm of a treatment group coming together with latanoprost / carteolol is a reference group． As for Primary Outcome and Secondary Outcome analysis , the OPC-1085EL group was compared only to the carteolol group, not to the latanoprost/carteolol concomitant group.
The number of subjects showed in the Participant Flow comes from all the subjects administered IMP. For efficacy analysis, on the other hand, several subjects were excluded from the analysis according to the statistical analysis plan. For example, subjects without IOP after administration were excluded. In addition, IOP measurement at 8 hours was not mandatory. That is why there are differences between the number in the Participant Flow and Outcome."|Week 8 at 2 hours after IMP administration|||mmHg||Standard Error|Mean
648386|NCT02105285|Secondary|Intraocular Pressure at Week 8 Predose|"Comparison of each group in intraocular pressure at Week 8 Predose. Arm of a treatment group coming together with latanoprost / carteolol is a reference group． As for Primary Outcome and Secondary Outcome analysis , the OPC-1085EL group was compared only to the carteolol group, not to the latanoprost/carteolol concomitant group.
The number of subjects showed in the Participant Flow comes from all the subjects administered IMP. For efficacy analysis, on the other hand, several subjects were excluded from the analysis according to the statistical analysis plan. For example, subjects without IOP after administration were excluded. In addition, IOP measurement at 8 hours was not mandatory. That is why there are differences between the number in the Participant Flow and Outcome."|Week 8 Predose|||mmHg||Standard Error|Mean
648387|NCT02105285|Primary|Decrease From Baseline in Intraocular Pressure at Week 8 Predose|"Comparison of each group in change from baseline in intraocular pressure. Arm of a treatment group coming together with latanoprost / carteolol is a reference group． As for Primary Outcome and Secondary Outcome analysis , the OPC-1085EL group was compared only to the carteolol group, not to the latanoprost/carteolol concomitant group."|Baseline, Week 8 Predose|||mmHg||95% Confidence Interval|Mean
648388|NCT02105272|Secondary|Decrease From Baseline in Intraocular Pressure at Week 8 at 8 Hours After IMP Administration|"Comparison of each group in change from baseline in intraocular pressure at 8 at 8 hours after IMP administration.
The number of subjects showed in the Participant Flow comes from all the subjects administered IMP. For efficacy analysis, on the other hand, several subjects were excluded from the analysis according to the statistical analysis plan. For example, subjects without IOP after administration were excluded. In addition, IOP measurement at 8 hours was not mandatory. That is why there are differences between the number in the Participant Flow and Outcome."|Baseline, Week 8 at 8 hours after IMP administration|||mmHg||95% Confidence Interval|Mean
648389|NCT02105272|Secondary|Decrease From Baseline in Intraocular Pressure at Week 8 at 2 Hours After IMP Administration|"Comparison of each group in change from baseline in intraocular pressure at Week 8 at 2 hours after IMP administration.
The number of subjects showed in the Participant Flow comes from all the subjects administered IMP. For efficacy analysis, on the other hand, several subjects were excluded from the analysis according to the statistical analysis plan. For example, subjects without IOP after administration were excluded. In addition, IOP measurement at 8 hours was not mandatory. That is why there are differences between the number in the Participant Flow and Outcome."|Baseline, Week 8 at 2 hours after IMP administration|||mmHg||95% Confidence Interval|Mean
648390|NCT02105272|Secondary|Intraocular Pressure at Week 8 at 8 Hours After IMP Administration|"Comparison of each group in intraocular pressure at Week 8 at 8hours after IMP administration.
The number of subjects showed in the Participant Flow comes from all the subjects administered IMP. For efficacy analysis, on the other hand, several subjects were excluded from the analysis according to the statistical analysis plan. For example, subjects without IOP after administration were excluded. In addition, IOP measurement at 8 hours was not mandatory. That is why there are differences between the number in the Participant Flow and Outcome."|Week 8 at 8 hours after IMP administration|||mmHg||Standard Error|Mean
648391|NCT02105272|Secondary|Intraocular Pressure at Week 8 at 2 Hours After IMP Administration|"Comparison of each group in intraocular pressure at Week 8 at 2 hours after IMP administration.
The number of subjects showed in the Participant Flow comes from all the subjects administered IMP. For efficacy analysis, on the other hand, several subjects were excluded from the analysis according to the statistical analysis plan. For example, subjects without IOP after administration were excluded. In addition, IOP measurement at 8 hours was not mandatory. That is why there are differences between the number in the Participant Flow and Outcome."|Week 8 at 2 hours after IMP administration|||mmHg||Standard Error|Mean
648392|NCT02105272|Secondary|Intraocular Pressure at Week 8 Predose|Comparison of each group in intraocular pressure at Week 8 Predose. The number of subjects showed in the Participant Flow comes from all the subjects administered IMP. For efficacy analysis, on the other hand, several subjects were excluded from the analysis according to the statistical analysis plan. For example, subjects without IOP after administration were excluded. In addition, IOP measurement at 8 hours was not mandatory. That is why there are differences between the number in the Participant Flow and Outcome.|Week 8 Predose|||mmHg||Standard Error|Mean
648393|NCT02105272|Primary|Decrease From Baseline in Intraocular Pressure||Baseline, week 8 predose|||mmHg||95% Confidence Interval|Mean
648394|NCT02105012|Secondary|Change From Baseline in Asthma Control Questionnaire (ACQ-5) Score|The ACQ-5 measures 5 symptoms (woken at night by symptoms, wake in the morning with symptoms, limitation of daily activities, shortness of breath, and wheeze). The scale is 0-6, where 0=minimum and 6=maximum|Baseline to End of Treatment Period (Day 29 or Day 15 if Day 29 is missing)|MITT||Scores on a scale||95% Confidence Interval|Least Squares Mean
648395|NCT02105012|Secondary|Change From Baseline in Mean Number of Puffs of Rescue Ventolin HFA|Change from baseline in mean number of puffs of rescue Ventolin HFA|Baseline to Last 7 Days of Treatment|MITT||Puffs/Day||95% Confidence Interval|Least Squares Mean
648396|NCT02105012|Secondary|Change From Baseline in Mean Evening Pre-dose Diary Peak Expiratory Flow Rate (PEFR)|Change From Baseline in Mean Evening Pre-dose Diary Peak Expiratory Flow Rate (PEFR)|Baseline to Last 7 Days of Treatment Period|MITT||Liters/min||95% Confidence Interval|Least Squares Mean
648397|NCT02105012|Secondary|Change From Baseline in Mean Morning Pre-dose Diary Peak Expiratory Flow Rate (PEFR)|Change From Baseline in Mean Morning Pre-dose Diary Peak Expiratory Flow Rate (PEFR)|Baseline to Last 7 Days of Treatment Period|MITT||Liters/min||95% Confidence Interval|Least Squares Mean
648398|NCT02105012|Primary|Change From Baseline in Morning Pre-dose Trough Forced Expiratory Volume in 1 Second (FEV1) at the End of the Treatment Period|Change from baseline in morning pre-dose trough Forced Expiratory Volume in 1 second (FEV1) at the end of the Treatment Period.|Baseline to End of Treatment Period (Day 29 or Day 15 if Day 29 is missing)|Modified Intent to Treat Population (MITT)||Liters||95% Confidence Interval|Least Squares Mean
648399|NCT02104947|Secondary|Reversal of Anticoagulation as Measured by Diluted Thrombin Time (dTT) or Ecarin Clotting Time (ECT) After the First Vial of Idarucizumab and Before the Start of Second Vial|"Reversal of anticoagulation as measured by diluted Thrombin Time (dTT) or Ecarin Clotting Time (ECT) after the first vial of idarucizumab and before the start of second vial.
Reversal is defined for patients with at least one post−dose coagulation test results and pre−dose result higher than 100% ULN (evaluable patients). Reversal is calculated as 100*(pre−dose value minus post dose value)/(pre−dose value minus 100% x ULN); if calculated reversal is > 100, it was set to 100."|after the first vial of idarucizumab and before the start of second vial on Day1|Treated Set||percentage||95% Confidence Interval|Median
648400|NCT02104947|Secondary|Cmin,1 of Unbound Sum (Free) Dabigatran|Cmin,1 (Minimum concentrations at any time point since the end of first vial of idarucizumab up to 4 hours after the completion of second vial) of unbound sum (free) dabigatran, provided that two vials given not more than 15 min apart in group A and B.|Since the end of first vial of idarucizumab up to 4 hours after the completion of second vial|The Pharmacokinetic Set (PKS): This analysis set was used for all PK analyses and was defined as all patients in the Treated Set who provided at least one PK data point.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
648401|NCT02104947|Secondary|Time to Cessation of Bleeding (for Group A Only)|Time to cessation of bleeding (for Group A only) since first infusion up to 24 hours after the completion of second infusion; bleeding status was to be categorized before and at several time points after treatment.|from the first infusion up to 24 hours after the last infusion on Day 1|Treated set with patients who stopped bleeding within 24 hours||hours||95% Confidence Interval|Median
648402|NCT02104947|Secondary|Occurrence of Major/Life-threatening/Fatal Bleeding (for Group B Only) Intraoperatively|Occurrence of major/life-threatening/fatal bleeding (for group B only) intraoperatively and up to 24 hours post-surgery were classified according to major or life-threatening bleeding (ISTH [International Society for Thrombosis and Hemostasis] definition). 95% Confidence Interval (CI) is from Clopper-Pearson method.|within 24 hours of surgery|Treated Set||percentage of participants||95% Confidence Interval|Number
648403|NCT02104947|Secondary|Duration of Reversal|Duration of reversal, defined as the time period a patient remained completely reversed based on dTT or ECT, up to 24 hours or re-starting the treatment of dabigatran.|from the first infusion up to 24 hours after the last infusion on Day 1|Treated Set||hours||Standard Deviation|Mean
648404|NCT02104947|Secondary|Reversal of aPTT and TT From Central Laboratory|"Reversal of anticoagulation as measured by Activated Partial Thromboplastin Time (aPTT) and Thrombin time (TT), at any time point since the end of first infusion up to 4 hours after the completion of the last infusion. Reversal is defined for patients with at least one post−dose coagulation test results and pre−dose result higher than 100% ULN (evaluable patients).
Reversal is calculated as 100* (pre−dose value minus post dose value)/(pre−dose value minus 100% x ULN); if calculated reversal is > 100, it was set to 100."|from the end of the first infusion up to 4 hours after the last infusion on Day 1|Treated Set||percentage||95% Confidence Interval|Median
648405|NCT02104947|Primary|Maximum Reversal of Anticoagulant Effect of Dabigatran Based on Central Laboratory Determination of dTT or ECT|"Maximum reversal of anticoagulant effect of dabigatran based on central laboratory determination of diluted thrombin time (dTT) or ecarin clotting time (ECT), at any time point from the end of the first infusion up to 4 hours after the last infusion.
Reversal is defined for patients with at least one post−dose coagulation test results and pre−dose result higher than 100% ULN (evaluable patients).
Reversal is calculated as 100* (pre−dose value minus post dose value)/(pre−dose value minus 100% x ULN); if calculated reversal is > 100, it was set to 100."|from the end of the first infusion up to 4 hours after the last infusion on Day 1|Treated Set||percentage||95% Confidence Interval|Median
648408|NCT02104895|Primary|Ipsilateral Breast Tumor Recurrence|"We defined local relapse (true recurrence) as the reappearance of the breast cancer in the index quadrant and ipsilateral breast tumours as any new breast cancer diagnosed in other quadrants of the same breast. The sum of local relapses and new ipsilateral breast tumours was defined as the ipsilateral breast tumour recurrence (IBTR). Locoregional tumour recurrence also included any recurrence in the ipsilateral axillary, supraclavicular, or internal mammary chain nodal regions.here we report the percentage of participants in each arm who experienced Ipsilateral Breast Tumor Recurrence"|5-year|||percentage of participants|||Number
648409|NCT02104830|Secondary|Duration From ANC Nadir to ANC < 2.0 x 10^9/L||1st cycle (week 3), 2nd cycle (week 6), 3rd cycle (week 9), 4th cycle (week 12)|The efficacy analysis included only those patients who received at least one dose of study drug, and who were participated in the study for 2 weeks or more.||days||Standard Deviation|Mean
648410|NCT02104830|Secondary|Neutropenia Duration, Any Grade||1st cycle (week 3), 2nd cycle (week 6), 3rd cycle (week 9), 4th cycle (week 12)|The efficacy analysis included only those patients who received at least one dose of study drug, and who were participated in the study for 2 weeks or more.||days||Standard Deviation|Mean
648411|NCT02104830|Secondary|Low Level (Nadir) ANC x 10^9/L||1st cycle (week 3), 2nd cycle (week 6), 3rd cycle (week 9), 4th cycle (week 12)|The efficacy analysis included only those patients who received at least one dose of study drug, and who were participated in the study for 2 weeks or more.||cells x 10^9/L||Standard Deviation|Mean
648412|NCT02104830|Secondary|The Incidence of Severe Neutropenia (Grade 3-4)||16 weeks|The efficacy analysis included only those patients who received at least one dose of study drug, and who were participated in the study for 2 weeks or more.||participants|||Number
648413|NCT02104830|Secondary|The Duration of Grade 4 Neutropenia From the 2nd (Week 6) to 4th Cycle (Week 12);||2nd cycle (week 6), 3rd cycle (week 9), 4th cycle (week 12)|The efficacy analysis included only those patients who received at least one dose of study drug, and who were participated in the study for 2 weeks or more.||days||Standard Deviation|Mean
648414|NCT02104830|Primary|Duration of Neutropenia CTCAE Grade 4|The primary endpoint, which will allow to compare the efficacy of the single dose of Extimia® versus nonpegylated daily filgrastim is the number of breast cancer patients developing CTCAE grade 3/4 neutropenia after the first AT chemotherapy cycle (doxorubicin+docetaxel).|3 weeks|The efficacy analysis included only those patients who received at least one dose of study drug, and who were participated in the study for 2 weeks or more.||days||Standard Deviation|Mean
648415|NCT02104804|Secondary|Analysis of Change in Mean Total Daily Dose of Insulin From Baseline to Week 24||Baseline to 24 weeks|232 and 230 indicate the number of participants with non-missing baseline and Week 24 values in the Full Analysis Set of 232 and 230 respectively.||IU||95% Confidence Interval|Least Squares Mean
648416|NCT02104804|Secondary|The Analysis of Change in Fasting Plasma Glucose From Baseline to Week 24 (This Was the Average of Weeks 20 and 24)||Baseline to Average of Weeks 20 and 24|232 and 229 indicate the number of participants with non-missing baseline and Week 24 values in the Full Analysis Set of 232 and 229 for this outcome measure respectively.||mg/dL||95% Confidence Interval|Least Squares Mean
648417|NCT02104804|Secondary|Percentage of Patients Achieving a Therapeutic Glycaemic Response of HbA1c <7%||At Week 24|229 and 227 indicate the number of participants with non-missing baseline and Week 24 values in the Full Analysis Set of 232 and 230 respectively.||% of participants|||Number
648418|NCT02104804|Secondary|Analysis of Change in 120-minute PPG From Baseline to Week 24 During a Meal Tolerance Test||Baseline to 24 weeks|215 and 211 indicate the number of participants with non-missing baseline and Week 24 values in the Full Analysis Set of 232 and 230 respectively.||mg/dL||95% Confidence Interval|Least Squares Mean
648419|NCT02104804|Secondary|Change in Postprandial Glucose AUC From Baseline to Week 24 During a Meal Tolerance Test||Baseline to 24 weeks|213 and 206 indicate the number of participants with non-missing baseline and Week 24 values in the Full Analysis Set of 232 and 230 respectively.||mg*min/dL||95% Confidence Interval|Least Squares Mean
648420|NCT02104804|Primary|Change in HbA1c From Baseline to Week 24||Baseline to 24 weeks|229 and 227 indicate the number of participants with non-missing baseline and Week 24 values in the Full Analysis Set of 232 and 230 respectively.||Percentage change||95% Confidence Interval|Least Squares Mean
648421|NCT02104219|Other Pre-specified|Rickets Severity Sale - RSS|The RSS is a 10-point scale, developed for nutritional rickets, that evaluates the degree of metaphyseal cupping and fraying and the proportion of growth plate affected (10 points = severe cupping/fraying, 0 points = absence of cupping/fraying).|Any available data during the period of patients’ aged 5 to 15 years, inclusive. Baseline is the earliest available assessment value during the period.|All patients who met all of the inclusion and none of the exclusion criteria were defined as the enrolled population, which was also the analysis population.||units on a scale||Inter-Quartile Range|Median
648422|NCT02104219|Secondary|Change in Weight Z-score From Baseline to Last Assessment|Weight measurements were assigned a Z-score which was calculated using the Centers for Disease Control and Prevention (CDC) 2000 growth charts and methodology. The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. Higher Z-scores indicate a better outcome.|Any available growth data during the period of patients’ aged 5 to 15 years, inclusive. Baseline is the earliest available assessment while Post baselines are time points after Baseline during the defined age period.|All patients who met all of the inclusion and none of the exclusion criteria were defined as the enrolled population, which was also the analysis population.||Z-score||Inter-Quartile Range|Median
648423|NCT02104219|Secondary|Change in Height Z-score From Baseline to Last Assessment|Height measurements were assigned to Z-scores which were calculated using the Centers for Disease Control and Prevention (CDC) 2000 growth charts and methodology. The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. Higher Z-scores indicate a better outcome.|Any available growth data during the period of patients’ aged 5 to 15 years, inclusive. Baseline is the earliest available assessment while post baselines are time points after Baseline during the defined age period.|||Z-score||Inter-Quartile Range|Median
648444|NCT02103114|Secondary|Incidence of Mediastinal Exploration Within 24 Hours Postoperatively|Study the safety profile of dosing the ATIII by monitoring the incidence of mediastinal exploration within 24 hours postoperatively|Baseline (intraoperatively) (Time 1) to Time 7 (Post OP Day 4)|||count of participants|||Number
648424|NCT02104219|Primary|Radiographic Global Impression of Change - RGI-C|The RGI-C scale is a 7-point ordinal scale that is used to evaluate musculoskeletal characteristics of HPP (eg, metaphyseal fraying, demineralization of distal metaphyses). The scores range from -3 (severe worsening) to +3 (complete or near-complete healing).|Between Baseline (earliest available, complete, and readable x-ray set) and all available, readable post-Baseline x-ray sets during the period of patients' aged 5 to 15 years, inclusive.|Patients diagnosed with juvenile-onset HPP.||units on a scale||Inter-Quartile Range|Median
648425|NCT02103855|Secondary|Pancreas Transplant Function as Measured by Fasting Serum Glucose Level.|Fasting Serum Glucose level measured at 1 year after conversion from Tacrolimus to Belatacept.|1 Year|4 subjects who completed 1 year of Belatacept.||mg/dl||Standard Deviation|Mean
648426|NCT02103855|Secondary|Change From Baseline Serum Hemoglobin A1c|Pancreas Transplant Function was measured by assessing change in Pre HbA1c to Post HbA1c at1 year after conversion.|Baseline and 1 year|||percentage of glycosylated hemoglobin||Standard Deviation|Mean
648427|NCT02103855|Secondary|Number of Participants With Pancreas Transplant Rejection|Pancreas Rejection as measured by serum amylase, serum lipase.|1 year|||Participants|||Count of Participants
648428|NCT02103855|Primary|Serum Creatinine at Year 1|Serum Creatinine measured at 1 year after conversion from Tacrolimus to Belatacept.|1 year|4 subjects who completed 1 year of Belatacept were analyzed.||mg/dl||Standard Deviation|Mean
648429|NCT02103855|Primary|Change From Baseline in Serum Estimated Glomerular Filtration Rate (eGFR)|Change in serum eGFR from baseline to 1 year following conversion from tacrolimus to belatacept|Baseline and 1 year|||ml/min/1.73m2||Standard Deviation|Mean
648430|NCT02103439|Secondary|Biochemical Response|Proportion of patients in each group with alanine aminotransferase level ≤ upper normal limit after 12 weeks of therapy|12 weeks|||percentage of patients|||Number
648431|NCT02103439|Primary|Early Virological Response in Patients With Different Hepatitis C Virus Genotypes|Proportion of randomized patients with different Hepatitis C Virus (HCV) genotypes achieving early virologic response - negative polymerase chain reaction result for HCV ribonucleic acid (< 15 IU/ml) or ≥ 2log10 decrease of viral load after 12 weeks of study treatment|12 weeks|||percentage of patients|||Number
648432|NCT02103439|Secondary|Viral Breakthrough|Proportion of patients in each groups with level of Hepatitis C Virus ribonucleic acid > 15 IU/ml after Hepatitis C Virus ribonucleic acid was not present or Hepatitis C Virus ribonucleic acid was increased by more than 1log10 from baseline at 4 or 12 weeks of treatment|screening data and at 4 or 12 weeks of treatment.|||percentage of patients|||Number
648433|NCT02103439|Secondary|Rapid Virological Response in Patients With Different Hepatitis C Virus Genotypes|Proportion of randomized patients with different Hepatitis C Virus (HCV) genotypes achieving rapid virological response - negative polymerase chain reaction result for HCV ribonucleic acid (< 15 IU/ml) after 4 weeks of treatment|4 weeks|||percentage of patients|||Number
648434|NCT02103439|Secondary|Rapid Virological Response|Proportion of randomized patients achieving rapid virologic response - negative polymerase chain reaction result for Hepatitis C Virus ribonucleic acid (< 15 IU/ml) after 4 weeks of treatment|4 weeks|||percentage of patients|||Number
648435|NCT02103439|Primary|Early Virological Response|Proportion of randomized patients achieving early virologic response - negative polymerase chain reaction result for Hepatitis C Virus ribonucleic acid (< 15 IU/ml) or ≥ 2log10 decrease of viral load after 12 weeks of study treatment|12 weeks|||percentage of patients|||Number
648436|NCT02103309|Secondary|Average Subjective Ratings Score (Lens Wearing Conditions and Visual Performance During Ball Sports)|The participant rated the lens wearing conditions and visual performance of the contact lenses during ball sports on a 10-point scale, where 10=Agree and 1=Disagree. “Overall Vision” was rated with 10=Excellent and 1=Poor. Both eyes contributed to the mean.|After 1 week of wear|This analysis population includes all enrolled participants minus missing data.||units on a scale||Standard Deviation|Mean
648437|NCT02103309|Secondary|Average Subjective Ratings Score (Lens Handling and Overall Vision)|The participant rated the handling and overall vision of the contact lenses on a 10-point scale, where 10=Excellent and 1=Poor. Both eyes contributed to the mean.|After 1 week of wear|This analysis population includes all enrolled participants minus missing data.||units on a scale||Standard Deviation|Mean
648438|NCT02103309|Secondary|Mean Investigator-Rated Lens Fit|Lens fit was assessed by the investigator and rated on a 5-point scale with -2=Unacceptable tight fit, -1=Acceptable tight fit, 0=Optimal, 1=Acceptable loose fit, and 2=Uacceptable loose fit. Both eyes contributed to the mean.|After 1 week of wear|This analysis population includes all enrolled participants minus missing data.||units on a scale||Standard Deviation|Mean
648439|NCT02103309|Primary|Mean Investigator-Rated Lens Centration|Lens centration was assessed by the investigator using slit-lamp microscopy and rated on a 5-point scale, where 0=Optimal and 4=Severe decentration. Both eyes contributed to the mean.|After 1 week of wear|This analysis population includes all enrolled participants minus missing data.||units on a scale||Standard Deviation|Mean
648440|NCT02103114|Secondary|Length of Time to Delayed Sternal Closure Measured in Days|Study the safety profile of dosing the ATIII by monitoring the length of time to delayed sternal closure measured in days|Baseline (intraoperatively) (Time 1) to Time 7 (Post OP Day 4)|||days||Standard Deviation|Mean
648441|NCT02103114|Secondary|Incidence (Number) of Newly Diagnosed Intracranial Hemorrhage|Study the safety profile of dosing the ATIII by monitoring the incidence (number) of newly diagnosed intracranial hemorrhage|Baseline (intraoperatively) (Time 1) to Time 7 (Post OP Day 4)|||participants|||Number
648442|NCT02103114|Secondary|Incidence of New Onset Renal Failure, Defined by Stage 3 of the AKIN Criteria|"Study the safety profile of dosing the ATIII by monitoring the incidence of new onset renal failure, defined by stage 3 of the Acute Kidney Injury Network (AKIN) criteria.
Serum creatinine increase ≥26.5 μmol/l (≥0.3 mg/dl) or increase to 1.5–2.0-fold from baseline, urine output <0.5 ml/kg/h for 6 hours
Serum creatinine increase >2.0–3.0-fold from baseline, urine output <0.5 ml/kg/h for 12 hours
Serum creatinine increase >3.0-fold from baseline or serum creatinine ≥354 μmol/l (≥4.0 mg/dl) with an acute increase of at least 44 μmol/l (0.5 mg/dl) or need for Renal replacement therapy (RRT), urine output <0.3 ml/kg/h for 24 h or anuria for 12 hours or need for RRT"|Baseline (intraoperatively) (Time 1) to Time 7 (Post OP Day 4)|||count of participants|||Number
648443|NCT02103114|Secondary|Incidence (Number) of Thrombotic Events Documented|Study the safety profile of dosing the ATIII by monitoring the incidence (number) of thrombotic events documented.|Baseline (intraoperatively) (Time 1) to Time 7 (Post OP Day 4)|||events|||Number
648448|NCT02103114|Secondary|Number of Total Blood Product Units Transfused 24-hours Post-operatively by Group|Number of total blood product units (including packed Fresh frozen plasma units, Platelet Units, cryo-precipitate units, and Red Blood Cell units) transfused 24 hours post-operatively for each group (not total units transfused for each subject)|24 Hours Post-Operatively|||Units|||Number
648449|NCT02103114|Secondary|Number of Total Blood Product Units Transfused by Type 24-hours Post-operatively by Group|Number of packed Fresh frozen plasma units, Platelet Units, cryo-precipitate units, and Red Blood Cell units transfused 24 hours post-operatively for each group (not total units transfused for each subject)|24 Hours Post-Operatively|Unable to be calculated accurately as blood products given in CPB prime were only designated in Units administered and not mls (no record of how many mls present in each unit). Therefore unable to back calculate total mls given from start of surgery to 24 hours postop||Units|||Number
648450|NCT02103114|Secondary|Chest Tube Output (Protamine Time Plus 24 Hours) in Milliliters|Chest Tube output (protamine time plus 24 hours) in milliliters|protamine time plus 24 hours|||milliters||Inter-Quartile Range|Median
648451|NCT02103114|Secondary|Volume of Postoperative Blood Loss|Volume of postoperative blood loss from 10min post protamine administration to 24 hour post protamine administration- (ml/kg)|From 10min post protamine administration to 24 hour post protamine administration|||ml/kg||Standard Deviation|Mean
648452|NCT02103114|Secondary|Incidence of Recombinant Factor 7a (VIIa) Use Intraoperatively|Incidence of Recombinant Factor 7a (VIIa) Use Intraoperatively|Baseline (Intraoperatively)|||count of participants|||Number
648453|NCT02103114|Secondary|Total Volume of Fresh Frozen Plasma Given Prior to CPB|Total volume of Fresh Frozen Plasma given prior to CPB, including the pump prime (ml/kg)|Baseline (intraoperatively) (Time 1) to before termination of bypass (Time 4)|||ml/kg||Standard Deviation|Mean
648454|NCT02103114|Secondary|Time From Protamine Administration to Skin Dressing|Time from protamine administration to skin dressing|Baseline (intraoperatively) (Time 1) to before termination of bypass (Time 4)|||minutes||Inter-Quartile Range|Median
648455|NCT02103114|Secondary|Total Volume of Blood Products While on CPB|Total volume of blood products exposed intraoperatively including the pump prime (ml/kg)|Baseline (intraoperatively) (Time 1) to before termination of bypass (Time 4)|||mls||Standard Deviation|Mean
648456|NCT02103114|Secondary|Protamine Dose Determined by Hemostasis Management System Machine (mg/kg)|Protamine dose determined by Hemostasis Management system machine (mg/kg)|T1 (Baseline) to T5 (Arrival in ICU)|||mg/kg||Inter-Quartile Range|Median
648457|NCT02103114|Secondary|Total Dose of Heparin While on Cardiopulmonary Bypass|Total dose of Heparin while on Cardiopulmonary Bypass|T1 (Baseline) to T5 (Arrival in ICU)|||units||Inter-Quartile Range|Median
648458|NCT02103114|Secondary|Evidence of Decreased Inflammation Represented by a Decrease in Inflammatory Markers in the ATIII Group|Evidence of decreased inflammation represented by a decrease in inflammatory markers in the ATIII group.|Baseline (T1) to Post-Operative Day 4 (T7)|Laboratory testing not performed.|||||
648459|NCT02103114|Secondary|Residual Heparin at the ICU Arrival Time Point Represented by a Decreased Anti Factor Xa Level.|Evidence of a decreased amount of residual heparin at the Intensive Care Unit arrival time point (T5) represented by a decreased anti factor Xa level.|T5 (Intensive Care Unit Arrival)|In both arms, heparin level was undetectable as Anti factor Xa level was less than or equal to 0.1 IU/ml in all subjects.||International Units/milliter||Standard Deviation|Mean
648460|NCT02103114|Secondary|Difference in the Median of the D Dimer of the Control and ATIII Groups at T1, T5, T6 and T7|Evidence of decreased activation of the coagulation and fibrinolytic systems represented by a difference in the median of the D dimer of the control and ATIII groups at T1 (Baseline), T5 (Arrival in Intensive Care Unit), T6 (Post-Operative Day 2) and T7 (Post-Operative Day 4).|T1, T5, T6 and T7|||mcg/ml||Inter-Quartile Range|Median
648461|NCT02103114|Secondary|Difference in the Median of the ATIII (Functional Assay) of the Control and ATIII Groups at T4|Evidence of decreased activation of the coagulation and fibrinolytic systems represented by a difference in the median of the ATIII (functional assay) of the control and ATIII groups at T4 (just prior to coming off of CPB). Data reported as % Functional Activity, which is calculated as the ability of Antithrombin (AT) to suppress FIIa or FXa in the presence of heparin compared to normograms, and expressed as a percentage.|T4 (just prior to coming off of CPB)|||% Functional Activity||Inter-Quartile Range|Median
648462|NCT02103114|Secondary|Difference in the Mean the ATIII (Functional Assay) of the Control and ATIII Groups at T1, T2, T3, T5, T6 and T7|Evidence of decreased activation of the coagulation and fibrinolytic systems represented by a difference in the mean of the ATIII (functional assay) of the control and ATIII groups at T1, T2, T3, T5, T6 and T7 (Baseline, 30 min after study drug, 30 min on CPB, Arrival in ICU, POD 2, and POD 4). Data reported as % Functional Activity, which is calculated as the ability of Antithrombin (AT) to suppress FIIa or FXa in the presence of heparin compared to normograms, and expressed as a percentage.|T1, T2, T3, T5, T6 and T7|||% Functional Activity||Standard Deviation|Mean
648463|NCT02103114|Secondary|Difference in the Mean and SD of the Calibrated Automated Thrombography (CAT) Measurements of the Control and ATIII Groups at Times 5-Time 7 (ICU Arrival to Post Operative Day 4)|Evidence of decreased activation of the coagulation and fibrinolytic systems represented by a difference in the mean and SD of the Calibrated Automated Thrombography (CAT) measurements of the control and ATIII groups at times 5-Time 7 (ICU arrival to Post Operative Day 4)|ICU arrival (Time 5) to Time 7 (Post-operative Day 4)|The laboratory was unable to perform this blood assay due to technical difficulties and no results were generated.|||||
648464|NCT02103114|Primary|Difference in the Mean and Standard Deviation (SD) of the Calibrated Automated Thrombography (CAT) Measurements of the Control and ATIII Groups at Time 5 (on Arrival in ICU)|Evidence of decreased activation of the coagulation and fibrinolytic systems represented by a difference in the mean and Standard Deviation (SD) of the Calibrated Automated Thrombography (CAT) measurements of the control and ATIII groups at Time 5 (on arrival in ICU).|Time 5 (on arrival in ICU)|The laboratory was unable to perform this blood assay due to technical issues and no results were generated.|||||
648465|NCT02103062|Other Pre-specified|Kaplan Meier Estimate of PFS by Investigator Assessment|PFS was measured as time from the date of first dose to the date of disease progression according to RECIST 1.1 or death from any cause, whichever was earlier.|Up to 241 days|Intent-to-treat Population defined as participants who received treatment and met all eligibility criteria||weeks||95% Confidence Interval|Median
653965|NCT01972776|Primary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) (Part 2)||Baseline, 8 weeks|Part 2 was terminated early. Therefore, primary and secondary outcomes for part 2 were not assessed.|||||
648466|NCT02103062|Secondary|Number of Participants With Adverse Events|A treatment emergent adverse events (TEAE) was defined as any AE occurring or worsening on or after the first dose of study drug and within 28 days after the last dose of study drug. A TESAE is defined as any serious adverse event (SAE) occurring or worsening on or after the first dose of study drug and within 28 days after the last dose of study drug. Safety and Severity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0; Severity of AEs were graded (including second primary malignancies) as Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe; Grade 4- Lifethreatening; Grade 5-Fatal;|Time of the first dose of study treatment to 28 days after the last dose of study drug; maximum treatment duration was 24 weeks|Safety population includes all participants who received at least one dose of study treatment||participants|||Number
648467|NCT02103062|Secondary|Duration of Response (DOR)|Duration of response was defined as the time from the first tumor assessment when the confirmed CR/PR response criterion was met to the date of disease progression based on investigational assessment following RECIST 1.1.|Up to 241 days|The data from the primary efficacy endpoint met the stopping criteria defined by the Simon 2-stage design, which did not support further assessment of nab-paclitaxel as a monotherapy in the analysis of this group of participants. Duration of response was not analyzed as there were no responders observed in the study.|||||
648468|NCT02103062|Secondary|Percentage of Participants With Stable Disease for ≥ 8 Weeks, or Complete or Partial Response According to RECIST Version 1.1; Disease Control Rate (DCR)|DCR was defined as the combined incidence of stable disease confirmed CR or PR and stable disease (SD) measured at the Week 8 assessment or later.|At week 8 and later; up to day 241|ITT Population defined as participants who received treatment and met all eligibility criteria||Percentage of participants||95% Confidence Interval|Number
648469|NCT02103062|Secondary|Overall Response Rate (ORR)|"ORR was defined as the combined incidence of Complete Response (CR) and Partial Response (PR), confirmed no less than 4 weeks after the criteria for response were first met based on RECIST 1.1. Tumor responses were assessed every 2 cycles using RECIST 1.1 and defined as:
Complete response-disappearance of all target lesions
Partial response- At least a 30% decrease in the sum of diameters of target lesions from baseline
Stable disease-neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for Progressive disease (PD)
Progressive Disease- At least a 20% increase in the sum of diameters of target lesions from nadir."|Up to 241 days|ITT population defined as participants who received treatment and met all eligibility criteria.||percentage of participants||95% Confidence Interval|Number
648470|NCT02103062|Secondary|Overall Survival|Overall Survival was the time from the first dose of study drug to patient death from any cause.|Up to 241 days|The data from the primary efficacy endpoint met the stopping criteria defined by the Simon 2-stage design, which did not support further assessment of nab-paclitaxel as a monotherapy in the analysis of this group of participants. The study was stopped early and the analysis of overall survival was not performed.|||||
648471|NCT02103062|Primary|Progression Free Survival (PFS) Rate as Measured at Week 8|PFS rate was measured by Investigator Assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 from the start of study treatment to disease progression or death from any cause, whichever occurred first.|At week 8 assessment period; up to 56 days|Per the Simon 2-stage design, only 30 participants from Stage 1 (the first 15 participants in the Intent to Treat (ITT) population from each cohort) were included. The ITT population was defined as those who received treatment and met all eligibility criteria; four ineligible participants were excluded based on the protocol deviations/violations||percentage of participants||95% Confidence Interval|Number
648472|NCT02102932|Secondary|AUC(0-tz) of Metformin|Area under the concentration-time curve of the metformin in plasma over the time interval from 0 up to the last quantifiable data point|1 hour (h) before drug administration and 20 min (m), 40m, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|"Pharmacokinetic set (PKS):
The PKS included all evaluable subjects of the TS who provided at least 1 observation for at least 1 primary PK endpoint in both treatment periods without Important protocol violations (IPV) relevant to the evaluation of PK."||ng* h/mL||Geometric Coefficient of Variation|Geometric Mean
648473|NCT02102932|Secondary|AUC(0-tz) of Empagliflozin|Area under the concentration-time curve of the empagliflozin in plasma over the time interval from 0 up to the last quantifiable data point|1 hour (h) before drug administration and 20 min (m), 40m, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|"Pharmacokinetic set (PKS):
The PKS included all evaluable subjects of the TS who provided at least 1 observation for at least 1 primary PK endpoint in both treatment periods without Important protocol violations (IPV) relevant to the evaluation of PK."||nmol * h/L||Geometric Coefficient of Variation|Geometric Mean
648474|NCT02102932|Primary|Cmax for Metformin|Maximum measured concentration of the metformin in plasma|1 hour (h) before drug administration and 20 min (m), 40m, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|"Pharmacokinetic set (PKS):
The PKS included all evaluable subjects of the TS who provided at least 1 observation for at least 1 primary PK endpoint in both treatment periods without Important protocol violations (IPV) relevant to the evaluation of PK."||ng/mL||Geometric Coefficient of Variation|Geometric Mean
648475|NCT02102932|Primary|Cmax for Empagliflozin|Maximum measured concentration of the empagliflozin in plasma|1 hour (h) before drug administration and 20 min (m), 40m, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|"Pharmacokinetic set (PKS):
The PKS included all evaluable subjects of the TS who provided at least 1 observation for at least 1 primary PK endpoint in both treatment periods without Important protocol violations (IPV) relevant to the evaluation of PK."||nmol/L||Geometric Coefficient of Variation|Geometric Mean
648476|NCT02102932|Primary|AUC(0-∞) for Metformin|Area under the concentration-time curve of the metformin in plasma over the time interval from 0 extrapolated to infinity|1 hour (h) before drug administration and 20 min (m), 40m, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|"Pharmacokinetic set (PKS):
The PKS included all evaluable subjects of the TS who provided at least 1 observation for at least 1 primary PK endpoint in both treatment periods without Important protocol violations (IPV) relevant to the evaluation of PK."||ng * h/mL||Geometric Coefficient of Variation|Geometric Mean
648549|NCT02100514|Secondary|Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12||Baseline, Week 12|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."||mg/dL||Standard Deviation|Mean
648477|NCT02102932|Primary|AUC(0-∞) for Empagliflozin|Area under the concentration-time curve of the empagliflozin in plasma over the time interval from 0 extrapolated to infinity|1 hour (h) before drug administration and 20 min (m), 40m, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|"Pharmacokinetic set (PKS):
The PKS included all evaluable subjects of the TS who provided at least 1 observation for at least 1 primary PK endpoint in both treatment periods without Important protocol violations (IPV) relevant to the evaluation of PK."||nmol * h/L||Geometric Coefficient of Variation|Geometric Mean
648481|NCT02102399|Secondary|Post-treatment Questionnaire (Compliance With Intervention)|"The post-treatment questionnaire was based on the original designed by Roy (2003) for assessing the teachers' perception of voice improvement and compliance with the intervention. Participants rated their degree of compliance on a 3-point Likert scale (not at all/somewhat; moderate; a lot). The questionnaire was applied only after the intervention. The answers were dichotomized in two categories (moderate/a lot and not at all/somewhat). It was considered compliance the answers moderate and a lot in comparison of not at all/somewhat, considered as no compliance. The results were presented in frequency/percentage of subjects in each intervention."|After 6 weeks of intervention|Between-group analysis||percentage of subjects|||Number
648482|NCT02102399|Secondary|Post-treatment Questionnaire (Easier to Talk)|"The post-treatment questionnaire was based on the original designed by Roy (2003) for assessing the teachers' perception of voice improvement and compliance with the intervention. Participants rated their extent of improvement on a 3-point Likert scale (not at all/somewhat; moderate; a lot). The questionnaire was applied only after the intervention. The answers were dichotomized in two categories (moderate/a lot and not at all/somewhat). The results were presented in frequency/percentage of subjects that answered moderate/a lot in each intervention."|After 6 weeks of intervention|Between-group analysis||percentage of subjects|||Number
648483|NCT02102399|Secondary|Post-treatment Questionnaire (Voice Clearer)|"The post-treatment questionnaire was based on the original designed by Roy (2003) for assessing the teachers' perception of voice improvement and compliance with the intervention. Participants rated their extent of improvement on a 3-point Likert scale (not at all/somewhat; moderate; a lot). The questionnaire was applied only after the intervention. The answers were dichotomized in two categories (moderate/a lot and not at all/somewhat). The results were presented in frequency/percentage of subjects that answered moderate/a lot in each intervention."|After 6 weeks of intervention|Between-group analysis||percentage of subjects|||Number
648484|NCT02102399|Primary|Change in GNE|"Glottal to Noise Excitation ratio (GNE) is an acoustic measurement to calculate the noise in a series of pulses produced by the oscillation of the vocal folds. This parameter is based on the hypothesis that resulting pulses of vocal fold collision generate a synchronous excitation of different frequency bands. Moreover, the noise produced by the vocal folds compressed generates uncorrelated excitations.
Normal levels > 0.5 dB"|Baseline, 6 weeks|Between-group analysis (mean difference posttest minus pretest)||Decibel (dB)||Standard Deviation|Mean
648485|NCT02102399|Primary|Change in Noise|Noise is the analysis of aperiodic components of the sound's signal. It is an important correlate of that the human ear considers voice disorders. Normal levels < 2.5 dB|Baseline, 6 weeks|Between-group analysis (mean difference posttest minus pretest)||Decibel (dB)||Standard Deviation|Mean
648486|NCT02102399|Primary|Change in Shimmer|Shimmer measures the amplitude perturbations, e. g. how fast the amplitude changes on a sustained vowel for a few seconds. Shimmer high levels are normally associated with pathological voice. This can be attributed due to changes in size, shape or firmness of the vocal folds. Normal values < 6.5%|Baseline, 6 weeks|||percentage of shimmer||Standard Deviation|Mean
648487|NCT02102399|Primary|Change in Jitter|"Jitter is the perturbation cycle-to-cycle of the fundamental frequency. High levels of jitter are normally associated with pathological voice. The instability of the fundamental frequency can be attributed to changes in size, shape or firmness of the vocal folds.
Normal values must be < 0.6%."|Baseline, 6 weeks|Between-group analysis (mean difference posttest minus pretest)||percentage of jitter||Standard Deviation|Mean
648543|NCT02100514|Secondary|Absolute Change From Baseline in Ratio of Fasting Total Cholesterol (TC) to High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."||ratio||Standard Deviation|Mean
648488|NCT02102399|Primary|Change in Fundamental Frequency|The measurement of fundamental frequency directly reflects the rate of vibration of the vocal folds. The fundamental frequency term refers to the frequency of more occurrence of vocal fold vibration, featuring a certain production.|Baseline, 6 weeks|Between-group analysis (mean difference posttest minus pretest)||Hertz (Hz)||Standard Deviation|Mean
648489|NCT02102399|Primary|Change in Voice Handicap Index (VHI-10)|The voice handicap index (VHI) is a self-assessment questionnaire which quantifies the functional, physical and emotional impacts of a voice disorder on the quality of life. The VHI-10 is a reduced version and it consists of 10 questions about the severity of the voice problem perceived by the subject. It is presented as an ordinal scale (range 0-4) that indicates how frequently the subject has experienced the same situation (0 = never; 1 = almost never; 2 = sometimes; 3= almost always; 4 = always). Total VHI Score ranges from 0 (never) to 40 (always). Higher scores indicate greater voice handicap. Abnormal values > 11.|Baseline, 6 weeks|Between-group analysis (mean difference posttest minus pretest)||units on a scale||Standard Deviation|Mean
648490|NCT02102399|Primary|Acoustic Analysis (GNE) 2|"Glottal to Noise Excitation ratio (GNE) is an acoustic measurement to calculate the noise in a series of pulses produced by the oscillation of the vocal folds. This parameter is based on the hypothesis that resulting pulses of vocal fold collision generate a synchronous excitation of different frequency bands. Moreover, the noise produced by the vocal folds compressed generates uncorrelated excitations.
Normal levels > 0.5 dB"|Baseline, 6 weeks|Within-group analysis (pretest vs. posttest)||Decibel (dB)||Standard Deviation|Mean
648491|NCT02102399|Primary|Acoustic Analysis (Noise) 2|Noise is the analysis of aperiodic components of the sound's signal. It is an important correlate of that the human ear considers voice disorders. Normal levels < 2.5 dB|Baseline, 6 weeks|Within-group analysis (pretest vs. posttest)||Decibel (dB)||Standard Deviation|Mean
648492|NCT02102399|Primary|Acoustic Analysis (Shimmer) 2|"The shimmer measures the amplitude's disturbance, e. g. how fast the amplitude changes on a sustained vowel for a few seconds. Shimmer high levels are normally associated with pathological voice. This can be attributed due to changes in size, shape or firmness of the vocal folds.
Normal values < 6.5%."|Baseline, 6 weeks|Within-group analysis (pretest vs. posttest)||percentage of shimmer||Standard Deviation|Mean
648493|NCT02102399|Primary|Acoustic Analysis (Jitter) 2|"Jitter is the perturbation cycle-to-cycle of the fundamental frequency. High levels of jitter are normally associated with pathological voice. The instability of the fundamental frequency can be attributed to changes in size, shape or firmness of the vocal folds.
Normal values must be < 0.6%."|Baseline, 6 weeks|Within-group analysis (pretest vs. posttest)||percentage of jitter||Standard Deviation|Mean
648494|NCT02102399|Primary|Acoustic Analysis (Fundamental Frequency) 2|The measurement of fundamental frequency directly reflects the rate of vibration of the vocal folds. The fundamental frequency term refers to the frequency of more occurrence of vocal fold vibration, featuring a certain production.|Baseline, 6 weeks|Within-group analysis (pretest vs. posttest)||Hertz (Hz)||Standard Deviation|Mean
648495|NCT02102399|Primary|Voice Handicap Index (VHI-10) 2|The voice handicap index (VHI) is a self-assessment questionnaire which quantifies the functional, physical and emotional impacts of a voice disorder on the quality of life. The VHI-10 is a reduced version and it consists of 10 questions about the severity of the voice problem perceived by the subject. It is presented as an ordinal scale (range 0-4) that indicates how frequently the subject has experienced the same situation (0 = never; 1 = almost never; 2 = sometimes; 3= almost always; 4 = always). Total VHI Score ranges from 0 (never) to 40 (always). Higher scores indicate greater voice handicap. Abnormal values > 11.|Baseline, 6 weeks|Within-group analysis (pretest vs. posttest)||units on a scale||Standard Deviation|Mean
648496|NCT02102399|Primary|Acoustic Analysis (GNE)|"Glottal to Noise Excitation ratio (GNE) is an acoustic measurement to calculate the noise in a series of pulses produced by the oscillation of the vocal folds. This parameter is based on the hypothesis that resulting pulses of vocal fold collision generate a synchronous excitation of different frequency bands. Moreover, the noise produced by the vocal folds compressed generates uncorrelated excitations.
Normal levels > 0.5 dB"|Baseline, 6 weeks|Within-group analysis (pretest vs. posttest)||Decibel (dB)||Standard Deviation|Mean
648497|NCT02102399|Primary|Acoustic Analysis (Noise)|Noise is the analysis of aperiodic components of the sound's signal. It is an important correlate of that the human ear considers voice disorders. Normal levels < 2.5 dB|Baseline, 6 weeks|Within-group analysis (pretest vs. posttest)||Decibel (dB)||Standard Deviation|Mean
648498|NCT02102399|Primary|Acoustic Analysis (Shimmer)|"The shimmer measures the amplitude's disturbance, e. g. how fast the amplitude changes on a sustained vowel for a few seconds. Shimmer high levels are normally associated with pathological voice. This can be attributed due to changes in size, shape or firmness of the vocal folds.
Normal values < 6.5%."|Baseline, 6 weeks|Within-group analysis (pretest vs. posttest)||percentage of shimmer||Standard Deviation|Mean
648499|NCT02102399|Primary|Acoustic Analysis (Jitter)|"Jitter is the perturbation cycle-to-cycle of the fundamental frequency. High levels of jitter are normally associated with pathological voice. The instability of the fundamental frequency can be attributed to changes in size, shape or firmness of the vocal folds.
Normal values must be < 0.6%."|Baseline, 6 weeks|Within-group analysis (pretest vs. posttest)||percentage of jitter||Standard Deviation|Mean
648500|NCT02102399|Secondary|Post-treatment Questionnaire (Voice Symptoms Improvement)|"The post-treatment questionnaire was based on the original designed by Roy (2003) for assessing the teachers' perception of voice improvement and compliance with the intervention. Participants rated their extent of improvement on a 3-point Likert scale (not at all/somewhat; moderate; a lot). The questionnaire was applied only after the intervention. The answers were dichotomized in two categories (moderate/a lot and not at all/somewhat). The results were presented in frequency/percentage of subjects that answered moderate/a lot in each intervention."|After 6 weeks of intervention|Between-group analysis||percentage of participants|||Number
648501|NCT02102399|Primary|Acoustic Analysis (Fundamental Frequency)|The measurement of fundamental frequency directly reflects the rate of vibration of the vocal folds. The fundamental frequency term refers to the frequency of more occurrence of vocal fold vibration, featuring a certain production.|Baseline, 6 weeks|Within-group analysis (pretest vs. posttest)||Hertz (Hz)||Standard Deviation|Mean
648517|NCT02101112|Primary|Adjusted Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Apixaban|Maximum observed plasma concentration (Cmax) measured in nanograms per milliliter (ng/mL)|Days 1, 5, and 9 predose and 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60 and 72 hours post dose|All evaluable pharmacokinetic (PK) participants who were treated with apixaban||ng/mL||90% Confidence Interval|Geometric Mean
648502|NCT02102399|Primary|Voice Handicap Index (VHI-10)|The voice handicap index (VHI) is a self-assessment questionnaire which quantifies the functional, physical and emotional impacts of a voice disorder on the quality of life. The VHI-10 is a reduced version and it consists of 10 questions about the severity of the voice problem perceived by the subject. It is presented as an ordinal scale (range 0-4) that indicates how frequently the subject has experienced the same situation (0 = never; 1 = almost never; 2 = sometimes; 3= almost always; 4 = always). Total VHI Score ranges from 0 (never) to 40 (always). Higher scores indicate greater voice handicap. Abnormal values > 11.|Baseline, 6 weeks|Within-group analysis (pretest vs. posttest)||units on a scale||Standard Deviation|Mean
648503|NCT02101359|Primary|The Primary Efficacy Variable is Response Based on the Realisation of the Capsulorhexis Without Use of Any Additive Mydriatic Treatment.||Day 0|Modified ITT (mITT) Set: All randomised patients for whom there was evidence they used the study medication, and who satisfied the non-inclusion criterion concerning unauthorized previous and concomitant medications. Patients were assigned to the treatment group as treated.||percentage of responders|||Number
648504|NCT02101294|Secondary|Measurement of Increase in Wrist Swelling Following FingerRelief Typing|Before and after the typing session, the subject's wrist was measured. The mean change score of all participants is reported here.|Pre and Post|||centimeters||Standard Deviation|Mean
648505|NCT02101294|Primary|Length of Time Typing FingerRelief Prior to Experiencing Symptoms of CTS|Subjects were instructed to type until they experienced a change in symptoms, the length of time that the subjected typed until experiencing symptoms was recorded as this outcome measure, averaged across the two typing sessions that were FingerRelief.|Participants will be assessed at each study of 4 sessions, two typing with the traditional QWERTY keyboard and two typing with the experimental device, each typing session will be separated by approximately one week to allow CTS symptoms to subside|||minutes||Standard Deviation|Mean
648506|NCT02101294|Secondary|Measurement of Wrist Swelling Following Cessation of QWERTY Typing|Before and after typing, the subject's wrists were measured with a tape measure. The change score is reported here.|Participants will be assessed at each study of 4 sessions, two typing with the traditional QWERTY keyboard and two typing with the experimental device, each typing session will be separated by approximately one week to allow CTS symptoms to subside|||centimeters||Standard Deviation|Mean
648507|NCT02101294|Primary|Length of Time Typing QWERTY Prior to Experiencing Symptoms of CTS (Carpal Tunnel Syndrome)|Subjects were instructed to type until they experienced a change in symptoms, the length of time that the subjected typed until experiencing symptoms was recorded as this outcome measure. Length of time typing at each QWERTY session was averaged across the two sessions to determine Length of time typing QWERTY.|Participants will be assessed at each study of 4 sessions, two typing with the traditional QWERTY keyboard and two typing with the experimental device, each typing session will be separated by approximately one week to allow CTS symptoms to subside|||minutes||Standard Deviation|Mean
648508|NCT02101190|Primary|Area Under the Curve (AUC0-t)|BIA 9-1067 AUC0-t following a single dose of 50mg BIA 9-1067|pre-dose (within 1 hour before dose administration) and then at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 60 and 72 hours post-dose|||ng.hr/mL||Standard Deviation|Mean
648509|NCT02101190|Primary|Tmax - Time to Reach Cmax|BIA 9-1067 Tmax following a single dose of 50mg BIA 9-1067|pre-dose (within 1 hour before dose administration) and then at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 60 and 72 hours post-dose|||hours||Full Range|Median
648510|NCT02101190|Primary|Cmax - Maximum Plasma Concentration of BIA 9-1067|BIA 9-1067 Cmax following a single dose of 50mg BIA 9-1067|pre-dose (within 1 hour before dose administration) and then at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 60 and 72 hours post-dose|||ng/mL||Standard Deviation|Mean
648511|NCT02101112|Secondary|Relative Bioavailability (Frel) of Apixaban|Frel is calculated using the treatment ratio of AUC(INF) where the denominator is the AUC(INF) of the reference therapy, 10mg of Apixaban (whole tablet).|Days 1, 5 and 9 pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 9, 12 24, 36, 48, 60 and 72 hrs post dose|All evaluable pharmacokinetic (PK) participants who were treated with apixaban||ratio||Geometric Coefficient of Variation|Geometric Mean
648512|NCT02101112|Secondary|Terminal Plasma Half-life (T-HALF) of Apixaban|Terminal plasma half-life (T-HALF) was derived from plasma concentration versus time data. T-HALF was the time required for one half of the total amount of administered drug to be eliminated from the body.|Days 1, 5 and 9 pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 9, 12 24, 36, 48, 60 and 72 hrs post dose|All evaluable pharmacokinetic (PK) participants who were treated with apixaban||hours||Standard Deviation|Mean
648513|NCT02101112|Secondary|Time of Maximum Observed Plasma Concentration (Tmax) of Apixaban|Time of maximum observed plasma concentration (Tmax) measured in hours (h)|Days 1, 5 and 9 pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 9, 12 24, 36, 48, 60 and 72 hrs post dose|All evaluable pharmacokinetic (PK) participants who were treated with apixaban||hours||Full Range|Median
648514|NCT02101112|Secondary|Number of Participants With Serious Adverse Events, Death, or Discontinuation Due to Adverse Events by Study Completion|Adverse Event (AE) = any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Serious Adverse Event (SAE)= a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|Randomization to May 2014; approximately 6 weeks|All randomized and treated participants||participants|||Number
648515|NCT02101112|Primary|Adjusted Geometric Mean of Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] of Apixaban|Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Last Quantifiable Concentration [AUC (0-T)] is measured as nanograms multiplied by hours per milliliter (ng*h/mL)|Days 1, 5, and 9 predose and 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, and 72 hours post dose|All evaluable pharmacokinetic (PK) participants who were treated with apixaban||ng*h/mL||90% Confidence Interval|Geometric Mean
648516|NCT02101112|Primary|Adjusted Geometric Mean of Area Under the Plasma Concentration-time Curve (AUC) From Time Zero Extrapolated to Infinite Time [AUC(INF)] of Apixaban|Area Under the Plasma Concentration-time Curve (AUC) From Time of Zero Extrapolated to Infinite Time (INF) [AUC (INF)] is measured as nanograms multiplied by hours per milliliter (ng*h/mL)|Days 1, 5, and 9 predose and 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, and 72 hours post dose|All evaluable pharmacokinetic (PK) participants who were treated with apixaban||ng*h/mL||90% Confidence Interval|Geometric Mean
648519|NCT02101008|Primary|Overall Response Rate to Treatment of Melanoma With Disulfiram and Chelated Zinc|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT scanning of the chest, abdomen and pelvis, or PET/CT scanning.: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Response to treatment will be measured by RECIST evaluation at disease assessment time-points from date of randomization until the date of first documented progression or death from any cause whichever came first (up to five years).|||participants|||Number
648520|NCT02100839|Secondary|Very Low Density Lipoprotein Cholesterol (VLDL-C) Percent Change|Maximum observed percentage change in VLDL-C level relative to baseline for all time points measured in Parts A or Part B with highest dose, i.e. 3.54 mg/kg.|Part A (SAD): Day 1 to Day 15; Part B (MAD): Day 1 to Day 57|||Max % Change Versus Baseline||Standard Deviation|Mean
648521|NCT02100839|Primary|Number of Participants Who Incurred Moderate Treatment Emergent Events|"Safety and tolerability to AEM-28 were evaluated through the assessment of adverse events (i.e., seriousness, severity, relationship to the study medication, outcome, duration, and management), vital signs, 12-lead ECG, telemetry, clinical laboratory parameters, physical examination, and local response to each injection, and body weight (Part B only). Treatment-emergent adverse events were tabulated by treatment. Changes from baseline values in vital signs, ECG, clinical laboratory parameters, physical examination, and body weight (Part B only) were evaluated.
Safety and tolerability data were reported using descriptive statistics."|Part A (SAD): Day -1 to Day 15; Part B (MAD): Day 1 to Day 57|||Number of Participants|||Number
648522|NCT02100839|Primary|Number of Participants Who Incurred Mild Treatment Emergent Adverse Events|"Safety and tolerability to AEM-28 were evaluated through the assessment of adverse events (i.e., seriousness, severity, relationship to the study medication, outcome, duration, and management), vital signs, 12-lead ECG, telemetry, clinical laboratory parameters, physical examination, and local response to each injection, and body weight (Part B only). Treatment-emergent adverse events were tabulated by treatment. Changes from baseline values in vital signs, ECG, clinical laboratory parameters, physical examination, and body weight (Part B only) were evaluated.
Safety and tolerability data were reported using descriptive statistics."|Part A (SAD): Day -1 to Day 15; Part B (MAD): Day 1 to Day 57|||Number of Participants|||Number
648523|NCT02100839|Primary|Number of Participants Who Incurred at Least One Treatment Emergent Event|"Safety and tolerability to AEM-28 were evaluated through the assessment of adverse events (i.e., seriousness, severity, relationship to the study medication, outcome, duration, and management), vital signs, 12-lead ECG, telemetry, clinical laboratory parameters, physical examination, and local response to each injection, and body weight (Part B only). Treatment-emergent adverse events were tabulated by treatment. Changes from baseline values in vital signs, ECG, clinical laboratory parameters, physical examination, and body weight (Part B only) were evaluated.
Safety and tolerability data were reported using descriptive statistics."|Part A (SAD): Day -1 to Day 15; Part B (MAD): Day 1 to Day 57|||participants|||Number
648524|NCT02100826|Secondary|Pharmacokinetics: Maximum Concentration (Cmax) of Cephalexin||Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period|All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data.||Microgram per milliliter(µg/ml)||Geometric Coefficient of Variation|Geometric Mean
648525|NCT02100826|Secondary|Pharmacokinetics: Time to Reach Maximum Observed Concentration (Tmax) of Cephalexin Following a Single Dose Maximum||Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period|All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data||Hours||Standard Deviation|Median
648526|NCT02100826|Primary|Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of Cephalexin Following a Single Dose||Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period|All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data.||hour*microgram per milliliter(h*μg/mL)||Geometric Coefficient of Variation|Geometric Mean
648527|NCT02100644|Secondary|Number of Participants With Adverse Events (AEs), AEs Leading to Discontinuation of the Investigational Product and/or Withdrawal From the Study, Drug-related AEs, Deaths and Serious Adverse Events (SAEs) Throughout the Study|An AE is defined as untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in disability/incapacity, is a congenital anomaly/birth defect, based on medical or scientific judgement and all events of possible drug-induced liver injury.|From the start of study treatment until follow-up (up to 50 weeks)|Safety Population: comprised of participants who received at least one dose of the investigational product during the LTG Escalation Phase.||Participants|||Number
648528|NCT02100644|Secondary|Percentage of Participants Who Completed or Discontinued From the Study|Following cases were considered for participants to have completed a part of or whole of the study. For whole period completion: participants who completed the last LTG and VPA Maintenance Phase visit (M5) in the LTG and VPA Maintenance Phase and follow-up examination. For LTG Escalation Phase completion: participants who reached 200 mg/d of LTG (or 100-200 mg/d of LTG if there were safety concerns) within 8-18 weeks of the phase. For VPA Reduction Phase completion: participants who completed the last fixed dose of VPA Reduction Phase visit (0 mg/d) (FR4) of the phase. For LTG and VPA Maintenance Phase completion: participants who completed M5 of the phase. Participants who met any of the withdrawal criteria after the start of investigational product were considered to have discontinued the study. Percentage of participants who completed or discontinued/withdrawn from the study is presented.|Up to 50 weeks|Enrolled Population: comprised of all participants who had a Baseline (Week 0) visit.||Percentage of participants|||Number
648541|NCT02100514|Secondary|Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 100 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52||Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm respectively.||percentage of participants|||Number
648544|NCT02100514|Secondary|Absolute Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12||Baseline, Week 12|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."||mg/dL||Standard Deviation|Mean
648529|NCT02100644|Secondary|Change From Baseline in Quality of Life in Epilepsy for Adolescents (QOLIE-AD-48) in Participants Aged 15-17 Years|QOLIE-AD-48 is a questionnaire analyzed according to the scoring manual at Baseline, at the end of the LTG/VPA Maintenance Phase and withdrawals for participants aged 15-17 years (n=6). Particpants who has started by QOLIE-AD-48 were using the same questionnaire even after 18 years old. Overall score was calculated as an average of sub scores that were normalized to 0 to 100. QOLIE-AD-48 has 8 subscale items (epilepsy impact, memory/concentration, physical fuctioning, stigma, social support, school behavior, attitudes towards epilepsy and health perceptions). Higher score presents higher quality of life. Epileptic symptoms generally affect the QOL of participants, and so QOLIE-AD-48 is world widely used for the QOL assessment of non-adult participants. Baseline is defined as Day 1 (pre-dose) value. Change from Baseline is calculated as post-dose visit value minus Baseline value.|Baseline and up to 46 weeks|FAS Population. Only those participants available at the indicated phase were analyzed (represented by n=X in the category titles).||Units on a scale||Standard Deviation|Mean
648530|NCT02100644|Secondary|Change From Baseline in Quality of Life in Epilepsy-31-P (QOLIE-31-P) in Participants Aged 18 Years and Older|QOLIE-31-P is a questionnaire analyzed according to the scoring manual at Baseline, at the end of LTG/VPA Maintenance Phase and withdrawals for the participants aged 18 years and older (n=26, excluding 1 participant withdrawn due to protocol violation). Overall score was calculated as an average of sub scores that were normalized to 0 to 100. QOLIE-31-P has 7 subscale items (energy, mood, daily activities, cognition, medication effect, seizure worry and overall QOL). Higher score presents higher quality of life. Epileptic symptoms generally affect the QOL of participants, and so QOLIE-31-P is world widely used for the QOL assessment of adult participants. Baseline is defined as Day 1 (pre-dose) value. Change from Baseline is calculated as post-dose visit value minus Baseline value.|Baseline and up to 46 weeks|FAS Population. Only those participants available at the indicated phase were analyzed (represented by n=X in the category titles).||Scores on a scale||Standard Deviation|Mean
648531|NCT02100644|Secondary|Number of Days in Total That Epileptic Seizures Occurred up to the LTG and VPA Maintenance Phase|The participants with no seizure, had no record in seizure dairy. Only those participants with more than one seizure were assessed for this Outcome Measure.|Baseline and up to 46 weeks|FAS Population||Days|||Number
648532|NCT02100644|Primary|Percent Change in the VPA Dose|Percent change in VPA dose is calculated as (pre-dose - post-dose) / pre-dose x 100. Pre-dose is the VPA dose at the Baseline visit and post-dose is the last VPA dose during the LTG and VPA Maintenance Phase.|Baseline and at the end of the LTG and VPA Maintenance Phase, 24-46 weeks that can be varied by durations of the LTG Escalation Phase and VPA Reduction Phase|FAS Population||Percentage of reduction||Standard Deviation|Mean
648533|NCT02100644|Primary|Percentage of Participants Who Achieved Reduction in Daily VPA Dose|The VPA dose reduction from Baseline is defined as post VPA dose minus the Baseline VPA dose < 0. Baseline VPA dose is the dose at the Baseline visit (Week 0) and the post VPA dose is the last VPA dose during the LTG and VPA Maintenance Phase. Percentage of participants with dose reduction during the LTG and VPA Maintenance Phase is presented.|Baseline and at the end of the LTG and VPA Maintenance Phase, 24-46 weeks that can be varied by durations of the LTG Escalation Phase and VPA Reduction Phase|Full analysis set (FAS): comprised of all participants in the Safety Population who provided at least one efficacy data after the first dose of the investigational product during the LTG Escalation Phase.||Percentage of participants||95% Confidence Interval|Number
648534|NCT02100579|Secondary|Length of Hospitalization|The average time to discharge in hours. Participants were discharged home went physical therapy criteria were met.|0 to 192 hours|||hours||95% Confidence Interval|Mean
648535|NCT02100579|Secondary|Visual Analog Scale Pain Score|Visual Analog Scale pain score; 0 = no pain, 10 = excruciating pain) in the knee recorded every 6 hours up to 36hrs following surgery.|Pain burden at 36hr|||scores*hours||Inter-Quartile Range|Median
648536|NCT02100579|Primary|Opioid Consumption (mg morEq)|Opioid consumption (morphine equivalents)|36 hours|||Morphine Equivalents||Inter-Quartile Range|Median
648537|NCT02100514|Secondary|Percentage of Participants With Positive Anti-drug Antibodies (ADA) of PF-04950615|Percentage of participants with at least 1 positive ADA titer were reported. Participants with their ADA titer >=6.23 were considered to be ADA positive.|Baseline up to end of study (up to 58 weeks)|"Analysis set included all participants who received at least 1 dose of PF-04950615 150 mg. This outcome measure was planned not to be analysed for placebo reporting arm. Here N signifies number of participants who were evaluable for this outcome measure."||Percentage of participants|||Number
648538|NCT02100514|Secondary|Percentage of Participants With Adverse Events (AEs) Related to Type 1 and 3 Hypersensitivity Reactions and Injection Site Reactions|Type 1 hypersensitivity or allergic reactions were possible in response to any injected protein and included shortness of breath, urticaria, anaphylaxis and angioedema. Type 3 hypersensitivity reactions were similar to Type 1 hypersensitivity reactions but were likely to be delayed from the time of injection and included symptoms such as rash, urticaria, polyarthritis, myalgia’s, polysynovitis, fever and if severe then included glomerulonephritis. Injection site reactions included injection site bruising, discolouration, erythema, haematoma, haemorrhage, nodule, induration, inflammation, mass, pain, paraesthesia, pruritus, swelling, vesicles, warmth, scab and rash. Participants with type 1 or type 3 hypersensitivity reactions and participants with injection site reactions were reported in this outcome measure.|Baseline up to end of study (up to 58 weeks)|Safety analysis set included all participants who received at least 1 dose of study treatment.||Percentage of participants|||Number
648539|NCT02100514|Secondary|Plasma Concentration Versus Time Summary of PF-04950615||Week 12, 24, 52|"Analysis set included participants who received at least 1 dose of PF-04950615. This outcome measure was planned not to be analysed for placebo reporting arm. Here, n signifies those participants who were evaluable at specified time points."||microgram per milliliter||Standard Deviation|Mean
648540|NCT02100514|Secondary|Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 70 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52||Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm respectively.||percentage of participants|||Number
648542|NCT02100514|Secondary|Absolute Change From Baseline in Ratio of Fasting Apolipoprotein B (ApoB) to Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"FAS included all participants who were randomized. Here, n signifies number of participants evaluable at specified time points."||ratio||Standard Deviation|Mean
648550|NCT02100514|Secondary|Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Greater Than or Equal to (>=) 200 Milligram Per Deciliter (mg/dL) at Week 12||Baseline, Week 12|"A subset of FAS included all participants who were randomized and had TG >=200 mg/dL at pre-randomization. Here, n signifies number of participants evaluable at specified time points."||mg/dL||Standard Deviation|Mean
648551|NCT02100514|Secondary|Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Less Than (<) 200 Milligram Per Deciliter (mg/dL) at Week 12||Baseline, Week 12|"A subset of FAS included all participants who were randomized and had TG <200 mg/dL at pre-randomization. Here, n signifies number of participants evaluable at specified time points."||mg/dL||Standard Deviation|Mean
648552|NCT02100514|Secondary|Percent Change From Baseline in Fasting Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."||percent change||Standard Deviation|Mean
648553|NCT02100514|Secondary|Percent Change From Baseline in Fasting Apolipoprotein A-II (ApoA-II) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."||percent change||Standard Deviation|Mean
648554|NCT02100514|Secondary|Percent Change From Baseline in Fasting Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."||percent change||Standard Deviation|Mean
648555|NCT02100514|Secondary|Percent Change From Baseline in Fasting Triglycerides (TG) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."||percent change||Standard Deviation|Mean
648556|NCT02100514|Secondary|Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 and 52||Baseline, Week 24, 52|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."||percent change||Standard Deviation|Mean
648557|NCT02100514|Secondary|Percent Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."||percent change||Standard Deviation|Mean
648558|NCT02100514|Secondary|Percent Change From Baseline in Fasting Lipoprotein (A) (Lp[A]) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at the specified time points."||percent change||Standard Deviation|Mean
648559|NCT02100514|Secondary|Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Greater Than or Equal to (>=) 200 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"A subset of FAS included all participants who were randomized and had TG >=200 mg/dL at pre-randomization. Here, n signifies number of participants evaluable at specified time points."||percent change||Standard Deviation|Mean
648560|NCT02100514|Secondary|Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Less Than (<) 200 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"A subset of FAS included all participants who were randomized and had TG <200 mg/dL at pre-randomization. Here, n signifies number of participants who were evaluable at the specified time points."||percent change||Standard Deviation|Mean
648561|NCT02100514|Secondary|Percent Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at the specified time points."||percent change||Standard Deviation|Mean
648562|NCT02100514|Secondary|Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at the specified time points."||percent change||Standard Deviation|Mean
648563|NCT02100514|Secondary|Percent Change From Baseline in Fasting Total Cholesterol (TC) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at the specified time points."||percent change||Standard Deviation|Mean
648564|NCT02100514|Primary|Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12||Baseline, Week 12|"FAS included all participants who were randomized. Here, Number of participants analyzed (N) signifies number of participants who were evaluable for this outcome measure."||percent change||Standard Deviation|Mean
648565|NCT02100475|Secondary|Number of Treatment-emergent Confirmed Hypoglycaemic Episodes|Treatment-emergent hypoglycaemic episodes: if the onset of the episode occurred on or after the first day of investigational medicinal product administration, and no later than 7 days after the last day on investigational medicinal product. Confirmed hypoglycaemia: subject unable to treat himself/herself and/or have a recorded plasma glucose < 3.1 mmol/L (56 mg/dL).|Week 0 - 26|Safety analysis set (SAS) included all subjects receiving at least one dose of the investigational product or comparator (31 subjects). Confirmed hypoglycaemic episodes were reported by 2 subjects in IDegLira arm and 2 subjects in IDegLira + IAsp arm.||Number of episodes|||Number
648566|NCT02100475|Secondary|Change From Baseline in Body Weight|Change from baseline in body weight after 26 weeks of treatment.|Week 0, week 26|FAS included all randomised subject (31 subjects). Missing data were imputed using the LOCF method.||Kilograms||Standard Deviation|Mean
648567|NCT02100475|Primary|Change From Baseline in HbA1c (Glycosylated Haemoglobin)|Change from baseline in HbA1c after 26 weeks of treatment.|Week 0, week 26|Full analysis set (FAS) included all randomised subjects (31 subjects). Missing data were imputed using the last observation carried forward (LOCF) method.||Percentage of glycosylated haemoglobin||Standard Deviation|Mean
648568|NCT02100410|Secondary|Handling on Removal|Handling on removal (after 30 minutes of wear) was assessed by the participant on a scale from 1 to 10 (1=poor and 10=excellent). This outcome measure was pre-specified for the embossed lenses only (TEST1, TEST3, and TEST5).|Day 1|This analysis population includes all all randomized participants satisfying all of the inclusion/exclusion criteria.||units on a scale||Standard Deviation|Mean
648569|NCT02100410|Secondary|Lens Awareness|Lens awareness was assessed by the participant on a 5-point scale (0=none and 4=severe) within the first 5 minutes of wear for each eye separately.|Day 1|This analysis population includes all all randomized participants satisfying all of the inclusion/exclusion criteria.||units on a scale||Standard Deviation|Mean
648570|NCT02100410|Primary|Percentage of Lenses With Axis Orientation ≤ 10 Degrees From Ideal Location After 3 Minutes of Wear|Axis orientation (the rotational positioning of the lens on the eye) was indicated by an axis mark. The actual location of the axis mark was evaluated during slit lamp review and compared to the ideal location for the axis mark, with the difference measured in degrees (0 to +/- 180). The ideal location for the axis mark was iteration-specific (either 6 o'clock or 3 and 9 o'clock). This outcome measure was pre-specified for the embossed lenses only (TEST1, TEST3, and TEST5).|Day 1|This analysis population includes all all randomized participants satisfying all of the inclusion/exclusion criteria.||percentage of lenses|||Number
648571|NCT02100189|Secondary|Tolerability of FISH Spongy Cytology|Tolerability is defined as the patient's willingness to repeat procedure.|After completion of FISH and EGD|Intent to Treat (ITT)||percentage of subjects tolerating test|||Number
648572|NCT02100189|Secondary|Adverse Events Associated With FISH Sponge Cytology Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0|Descriptive statistics will be used to summarize all adverse events associated with FISH sponge cytology test.|At the time of sponge cytology procedure|Intent to Treat (ITT)||adverse events|||Number
648573|NCT02100189|Primary|Specificity of Sponge Cytology Using FISH|All processed (FISH) esophageal cells will be compared to the final pathologic esophageal diagnoses determined by EGD or surgical resection to assess the test’s sensitivity and specificity for the diagnosis of esophageal cancer. Using EGD diagnostic outcomes as the gold standard, the sensitivity and specificity will be computed with corresponding 95% confidence interval of the FISH sponge cytology test in the study population.|At the time of sponge cytology and EGD|Per protocol||Percentage of non-cases among neg tests||95% Confidence Interval|Number
648574|NCT02100189|Primary|Sensitivity of Sponge Cytology Using FISH|All processed (FISH) esophageal cells will be compared to the final pathologic esophageal diagnoses determined by EGD or surgical resection to assess the test’s sensitivity and specificity for the diagnosis of esophageal cancer. Using EGD diagnostic outcomes as the gold standard, the sensitivity and specificity will be computed with corresponding 95% confidence interval of the FISH sponge cytology test in the study population.|At the time of sponge cytology and EGD|Analysis was per protocol||percentage of cases among positive tests||95% Confidence Interval|Number
648575|NCT02100007|Secondary|Estimate the Overall Survival (OS)|41 subjects were analysed. Overall survival is defined as the first day of study drug administration to death.|Up to 2 years|||months||95% Confidence Interval|Median
648576|NCT02100007|Secondary|Estimate Overall Response Rate for ME-344 Given in Combination With Topotecan|Overall response rate was defined as the total number of patients with Complete Response plus Partial Response. All efficacy assessments were to include a baseline assessment and follow-up assessments at a minimum of every 8 weeks for the first 6 cycles, then every 12 weeks thereafter, while receiving study drug. Tumor response and progression-free survival were assessed using RECIST 1.1 criteria or GCIG criteria for CA-125 levels.|Response was assessed throughout the trial up to 13 months|Part 1 (N =12), Part 2 (N=29)||participants|||Number
648577|NCT02100007|Secondary|Mean Terminal Half-life (t 1/2)|Various pharmacokinetic parameters for ME-344 in plasma were calculated based on the plasma concentration data.|Cycle 1 Day 1, at 0, .5, 1, 2, 4, 6 and 24 hours post-dose and Day 15 at 0 and end of infusion|Samples were collected from patients in Part 1 of the study for measurement of plasma concentration of ME-344. Samples were collected from 13 patients in Part 1.||hours||Standard Deviation|Mean
648578|NCT02100007|Secondary|Minimum Plasma Concentration (Cmin) of ME-344|Various pharmacokinetic parameters for ME-344 in plasma were calculated based on the plasma concentration data.|Cycle 1 Day 1, at 0, .5, 1, 2, 4, 6 and 24 hours post-dose and Day 15 at 0 and end of infusion|Samples were collected from patients in Part 1 of the study for measurement of plasma concentration of ME-344. Samples were collected from 13 patients in Part 1.||ng/mL||Standard Deviation|Mean
648579|NCT02100007|Secondary|Time to Maximum Plasma Concentration for ME-344 (Tmax)|Various pharmacokinetic parameters for ME-344 in plasma were calculated based on the plasma concentration data.|Cycle 1 Day 1, at 0, .5, 1, 2, 4, 6 and 24 hours post-dose and Day 15 at 0 and end of infusion|Samples were collected from patients in Part 1 of the study for measurement of plasma concentration of ME-344. Samples were collected from 13 patients in Part 1||hours||Full Range|Mean
648580|NCT02100007|Secondary|Maximum Plasma Concentration (Cmax)|Peak Plasma Concentration (Cmax) of ME-344 in combination with topotecan|Cycle 1 Day 1, at 0, .5, 1, 2, 4, 6 and 24 hours post-dose and Day 15 at 0 and end of infusion|Pharmacokinetic parameters for ME-344 in plasma were calculated based on the plasma concentration data from 13 patients who received treatment in Part 1 of the study.||ng/mL||Standard Deviation|Mean
648581|NCT02100007|Primary|Number of Serious Adverse Events|The SAE Profile will be determined by the number of SAEs|Through study completion- an average of 2 years|46 subjects received > 2 doses of ME-344 and topotecan and were eligible for DLT analysis.||SAEs|||Number
648582|NCT02100007|Primary|Number of Adverse Events|The AE Profile will be determined by the number of AEs regardless of severity|Through study completion- an average of 2 years|46 subjects received > 2 doses of ME-344 and topotecan and were eligible for DLT analysis.||adverse events|||Number
648583|NCT02099838|Other Pre-specified|Change of DBil From Baseline at Week 12|Measuring venous level of DBil(direct bilirubin) at the start of the trail and at week 12 in all subjects, then analyzing the change in DBil from baseline at week 12 and comparing that between experiment group and control group. Change = (Baseline Level - Week 12 Level).|Baseline, Week 12|Based on safety set：all participants who received intervention at least once and had actual data of safety record.||mmol/L||Standard Deviation|Mean
648584|NCT02099838|Other Pre-specified|Change of TBil From Baseline at Week 12|Measuring venous level of TBil(total bilirubin) at the start of the trail and at week 12 in all subjects, then analyzing the change in TBil from baseline at week 12 and comparing that between experiment group and control group. Change = (Baseline Level - Week 12 Level).|Baseline, Week 12|Based on safety set：all participants who received intervention at least once and had actual data of safety record.||mmol/L||Standard Deviation|Mean
651494|NCT02028676|Primary|Induction ART: Change From Baseline in CD4% to 144 Weeks From ART Initiation||Baseline, 144 weeks|All participants alive in follow-up with CD4% (95% completeness)||percentage of total lymphocytes||Standard Error|Mean
648585|NCT02099838|Other Pre-specified|Change of AST From Baseline at Week 12|Measuring venous level of AST at the start of the trail and at week 12 in all subjects, then analyzing the change in AST from baseline at week 12 and comparing that between experiment group and control group. Change = (Baseline Level - Week 12 Level).|Baseline, Week 12|Based on safety set：all participants who received intervention at least once and had actual data of safety record.||U/L||Standard Deviation|Mean
648586|NCT02099838|Other Pre-specified|Change of ALT From Baseline at Week 12|Measuring venous level of ALT at the start of the trail and at week 12 in all subjects, then analyzing the change in ALT from baseline at week 12 and comparing that between experiment group and control group. Change = (Baseline Level - Week 12 Level).|Baseline, Week 12|Based on safety set：all participants who received intervention at least once and had actual data of safety record.||U/L||Standard Error|Mean
648587|NCT02099838|Secondary|Change of LDL From Baseline at Week 12|Measuring venous level of LDL(Low-Density Lipoprotein) at the start of the trail and at week 12 in all subjects, then using the natural logarithm of LDL to analyze the change in LDL from baseline at week 12 and compare that between experiment group and control group, since the LDL wasn't normal distribution and was logarithmic normal distribution. Change = ln(Baseline Level) - ln(Week 12 Level).|Baseline, Week 12|Based on the full analysis set: all participants who were eligible or drop-out, but eliminated participants were excluded.||ln(mmol/L)||Standard Deviation|Mean
648588|NCT02099838|Secondary|Change of HDL From Baseline at Week 12|Measuring venous level of HDL(High-Density Lipoprotein) at the start of the trail and at week 12 in all subjects, then analyzing the change in HDL from baseline at week 12 and comparing that between experiment group and control group. Change = (Baseline Level - Week 12 Level).|Baseline, Week 12|Based on the full analysis set: all participants who were eligible or drop-out, but eliminated participants were excluded.||mmol/L||Standard Deviation|Mean
648589|NCT02099838|Secondary|Change of TG From Baseline at Week 12|Measuring venous level of TG(Triglyceride) at the start of the trail and at week 12 in all subjects, then analyzing the change in TG from baseline at week 12 and comparing that between experiment group and control group. Change = (Baseline Level - Week 12 Level).|Baseline, Week 12|Based on the full analysis set: all participants who were eligible or drop-out, but eliminated participants were excluded.||mmol/L||Standard Deviation|Mean
648590|NCT02099838|Secondary|Change of TC From Baseline at Week 12|Measuring venous level of TC(Total Cholesterol) at the start of the trail and at week 12 in all subjects, then analyzing the change in TC from baseline at week 12 and comparing that between experiment group and control group. Change = (Baseline Level - Week 12 Level).|Baseline, Week 12|Based on the full analysis set: all participants who were eligible or drop-out, but eliminated participants were excluded.||mmol/L||Standard Deviation|Mean
648591|NCT02099838|Secondary|Change of 2-hour Postprandial Insulin From Baseline at Week 12|Measuring venous level of 2-hour postprandial insulin at the start of the trail and at week 12 in all subjects, then using the natural logarithm of 2-hour postprandial insulin to analyze the change in 2-hour postprandial insulin from baseline at week 12 and compare that between experiment group and control group, since the 2-hour postprandial insulin wasn't normal distribution and was logarithmic normal distribution. Change = ln(Baseline Level) - ln(Week 12 Level).|Baseline, Week 12|Based on the full analysis set: all participants who were eligible or drop-out, but eliminated participants were excluded.||ln(mU/L)||Standard Deviation|Mean
648592|NCT02099838|Secondary|Change of Fasting Insulin From Baseline at Week 12|Measuring venous level of fasting insulin at the start of the trail and at week 12 in all subjects, then using the natural logarithm of fasting insulin to analyze the change in fasting insulin from baseline at week 12 and compare that between experiment group and control group, since the fasting insulin wasn't normal distribution and was logarithmic normal distribution. Change = ln(Baseline Level) - ln(Week 12 Level).|Baseline, Week 12|Based on the full analysis set: all participants who were eligible or drop-out, but eliminated participants were excluded.||ln(mU/L)||Standard Deviation|Mean
648593|NCT02099838|Secondary|Change of 2hPPG From Baseline at Week 12|Measuring venous level of 2hPPG(2-hour postprandial glucose) at the start of the trail and at week 12 in all subjects, then analyzing the change in 2hPPG from baseline at week 12 and comparing that between experiment group and control group. Change = (Baseline Level - Week 12 Level).|Baseline, Week 12|Based on the full analysis set: all participants who were eligible or drop-out, but eliminated participants were excluded.||mmol/L||Standard Deviation|Mean
648594|NCT02099838|Secondary|Change of FPG From Baseline at Week 12|Measuring venous level of FPG(fasting plasma glucose) at the start of the trail and at week 12 in all subjects, then using the natural logarithm of FPG to analyze the change in FPG from baseline at week 12 and compare that between experiment group and control group, since the FPG wasn't normal distribution and was logarithmic normal distribution. Change = ln(Baseline Level) - ln(Week 12 Level).|Baseline, Week 12|Based on the full analysis set: all participants who were eligible or drop-out, but eliminated participants were excluded.||ln(mmol/L)||Standard Deviation|Mean
648595|NCT02099838|Primary|Change of HbA1c From Baseline at Week 12|Measuring venous level of HbA1c at the start of the trail and at week 12 in all subjects, then using the natural logarithm of HbA1c to analyze the change in HbA1c from baseline at week 12 and compare that between experiment group and control group, since the HbA1c wasn't normal distribution and was logarithmic normal distribution. Change = ln(Baseline Level) - ln(Week 12 Level).|Baseline, Week 12|Based on the full analysis set: all participants who were eligible or drop-out, but eliminated participants were excluded. Intention to treat analysis and last observational carried forward(LOCF) imputation method.||ln(percent)||Standard Deviation|Mean
648596|NCT02099708|Secondary|Treatment Outcome (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions|Summary of data on the outcome of treatment for gastric or duodenal ulcers or hemorrhagic lesions.|From baseline to 12 months|Efficacy Analysis Set: all participants from the SAS, excluding those for whom usage of NSAIDs during the treatment of lansoprazole was not confirmed and those who had gastric or duodenal ulcers at the start of administration of lansoprazole.||participants|||Number
648597|NCT02099708|Secondary|Details of Treatment for Gastric or Duodenal Ulcers or Hemorrhagic Lesions|"Summary of data on the details of treatment for gastric or duodenal ulcers or hemorrhagic lesions.
Participants could be counted in more than 1 treatment category."|From baseline to 12 months|Efficacy Analysis Set: all participants from the SAS, excluding those for whom usage of NSAIDs during the treatment of lansoprazole was not confirmed and those who had gastric or duodenal ulcers at the start of administration of lansoprazole.||participants|||Number
648598|NCT02099708|Secondary|Treatment for Gastric/Duodenal Ulcer or Lesion|Summary of data on the presence or absence of treatment for duodenal ulcers or hemorrhagic lesions.|From baseline to 12 months|Efficacy Analysis Set: all participants from the SAS, excluding those for whom usage of NSAIDs during the treatment of lansoprazole was not confirmed and those who had gastric or duodenal ulcers at the start of administration of lansoprazole.||participants|||Number
648599|NCT02099708|Secondary|Presence of Either Gastric/Duodenal Ulcer, or Gastric/Duodenal Hemorrhagic Lesion|Summary of data on the presence or absence of gastric/duodenal ulcer gastric/duodenal hemorrhagic lesion.|From baseline to 12 months|Efficacy Analysis Set: all participants from the SAS, excluding those for whom usage of NSAIDs during the treatment of lansoprazole was not confirmed and those who had gastric or duodenal ulcers at the start of administration of lansoprazole.||participants|||Number
648600|NCT02099708|Secondary|Presence of Onset of Gastric or Duodenal Hemorrhagic Lesion|Summary of data on the presence or absence of gastric or duodenal hemorrhagic lesion.|From baseline to 12 months|Efficacy Analysis Set: all participants from the SAS, excluding those for whom usage of NSAIDs during the treatment of lansoprazole was not confirmed and those who had gastric or duodenal ulcers at the start of administration of lansoprazole.||participants|||Number
648601|NCT02099708|Secondary|Presence of Gastric or Duodenal Ulcer|Summary of data on the presence or absence of gastric or duodenal ulcer.|From baseline to 12 months|Efficacy Analysis Set: all participants from the SAS, excluding those for whom usage of NSAIDs during the treatment of lansoprazole was not confirmed and those who had gastric or duodenal ulcers at the start of administration of lansoprazole.||Participants|||Number
648602|NCT02099708|Secondary|Presence or Absence of Endoscopic Examinations|Summary of data on the presence or absence of gastric or duodenal ulcers by using endoscopic examinations.|From baseline to 12 months|Efficacy Analysis Set: all participants from the SAS, excluding those for whom usage of NSAIDs during the treatment of lansoprazole was not confirmed and those who had gastric or duodenal ulcers at the start of administration of lansoprazole.||participants|||Number
648603|NCT02099708|Primary|Frequency of Adverse Drug Reactions|Frequency was defined as the number of participants for each adverse event Frequency, severity, and time to onset of adverse drug reactions tabulated by each symptom. Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.|12 months|Safety analysis set (SAS) - All participants who received at least 1 dose of open-label study drug.||participants|||Number
648604|NCT02099682|Secondary|Treatment Outcome (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions|Summary of data on the outcome of treatment for gastric or duodenal ulcers or hemorrhagic lesions.|From baseline to 12 months|Efficacy analysis set: all participants who took the study drug at least once excluding those with gastric ulcers or duodenal ulcers at initiation of study drug treatment, or participants for whom low-dose aspirin use during study drug treatment could not be confirmed.||participants|||Number
648605|NCT02099682|Secondary|Details of Treatment (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions|Summary of data on the details of treatment for gastric or duodenal ulcers or hemorrhagic lesions.|From baseline to 12 months|Efficacy analysis set: all participants who took the study drug at least once excluding those with gastric ulcers or duodenal ulcers at initiation of study drug treatment, or participants for whom low-dose aspirin use during study drug treatment could not be confirmed.||participants|||Number
648606|NCT02099682|Secondary|Treatment for Gastric/Duodenal Ulcer or Lesion|Summary of data on the presence or absence of treatment for duodenal ulcers or hemorrhagic lesions.|From baseline to 12 months|Efficacy analysis set: all participants who took the study drug at least once excluding those with gastric ulcers or duodenal ulcers at initiation of study drug treatment, or participants for whom low-dose aspirin use during study drug treatment could not be confirmed.||participants|||Number
648607|NCT02099682|Secondary|Presence of Either Gastric/Duodenal Ulcer, or Gastric/Duodenal Hemorrhagic Lesion|Summary of data on the presence or absence of gastric/duodenal ulcer gastric/duodenal hemorrhagic lesion.|From baseline to 12 months|Efficacy analysis set: all participants who took the study drug at least once excluding those with gastric ulcers or duodenal ulcers at initiation of study drug treatment, or participants for whom low-dose aspirin use during study drug treatment could not be confirmed.||participants|||Number
648608|NCT02099682|Secondary|Presence of Gastric or Duodenal Hemorrhagic Lesion|Summary of data on the presence or absence of gastric or duodenal hemorrhagic lesions.|From baseline to 12 months|Efficacy analysis set: all participants who took the study drug at least once excluding those with gastric ulcers or duodenal ulcers at initiation of study drug treatment, or participants for whom low-dose aspirin use during study drug treatment could not be confirmed.||participants|||Number
648609|NCT02099682|Secondary|Presence of Gastric or Duodenal Ulcer|Summary of data on the presence or absence of gastric or duodenal ulcers.|From baseline to 12 months|Efficacy analysis set: all participants who took the study drug at least once excluding those with gastric ulcers or duodenal ulcers at initiation of study drug treatment, or participants for whom low-dose aspirin use during study drug treatment could not be confirmed.||participants|||Number
648610|NCT02099682|Secondary|Presence or Absence of Endoscopic Examinations|Summary of data on the presence or absence of endoscopic examinations.|From baseline to 12 months|Efficacy analysis set: all participants who took the study drug at least once excluding those with gastric ulcers or duodenal ulcers at initiation of study drug treatment, or participants for whom low-dose aspirin use during study drug treatment could not be confirmed.||participants|||Number
648611|NCT02099682|Primary|Frequency of Adverse Drug Reactions|Frequency, severity, and time to onset of adverse drug reactions tabulated by each symptom. Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.|12 months|Safety analysis set - All participants who received at least 1 dose of lansoprazole.||participants|||Number
648641|NCT02098733|Secondary|Glycosylated Hemoglobin (HbA1c)|Tabulated glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at each test time point or final visit relative to baseline.|Baseline, and Months 3, 6, 9, 12 and at Final Assessment|All enrolled participants with data available.||percentage of glycosylated haemoglobin||Standard Deviation|Mean
648612|NCT02099461|Primary|Log Ratio of Post-baseline to Baseline Ki-67 Index in Mammary Epithelial Cells|Ki-67 is a marker for cell proliferation. Participants underwent percutaneous core needle breast biopsies on Day 1 (Baseline, prior to treatment) and Day 28. Levels of Ki67 were measured using immunohistochemical staining and digital imaging. The proliferation index was calculated as the percentage of Ki-67 positive terminal ductal lobular unit (TDLU) and duct epithelial cells. The higher the percentage, the higher the rate of epithelial cell proliferation.|Baseline and Day 28|Pharmacodynamic analysis set with non-missing data||log ratio||Standard Deviation|Mean
648613|NCT02099344|Secondary|Examine Incidence of Complications in Patients Receiving the Artegraft Bovine Graft vs. Gore Propaten Graft|Complication incidence will be collected from the time of access creation until the graft fails and is abandoned.|12 months||||||
648614|NCT02099344|Primary|Primary Objective: The Primary Objective is to Assess the Primary, Primary Assisted and Secondary Patency Rate of Each Graft|The primary outcome will be determined by Kaplan-Meier life table analysis. Patency determination will be from access creation until the first occlusion of the graft.|12 months|Data not collected due to early study termination|||||
648615|NCT02099318|Other Pre-specified|Wasted Number of Aneurysm Clips|Number of of aneurysm clips wasted according to OR records.|At time of surgery-Time (minutes/seconds) from first aneurysm clip attempt to final clip placement|Data was lost; no results can be reported|||||
648616|NCT02099318|Other Pre-specified|Microsurgical Time|"Number of minutes of total microsurgical time:
Defined as the time elapsed from the time the aneurysm was first observed in the OR microscope until the time that the final clip was applied"|At time of surgery-Total time (minutes/seconds) from aneurysm first seen in video to final clip placement|Data was lost; no results can be reported|||||
648617|NCT02099318|Other Pre-specified|Temporary Clip Time|"Total Number of minutes of temporary clip occlusion:
Defined as the time the temporary clip is released from the clip applier until the temporary clip is removed. (For several temporary occlusions, a cumulative total of all temporary occlusions and total time of overall temporary occlusion time as observed in the operating microscope's video.)"|At time of surgery-Total time (minutes/seconds) of all temporary clip applications to all temporary clip removal|Data was lost; no results can be reported|||||
648618|NCT02099318|Secondary|Number of Trial Aneurysm Clips Used But Not Implanted|"Number of Clips evaluated:
Defined as clips that were brought in proximity to the aneurysm for evaluation (i.e., were visible in the microscopic field) but were not applied, as observed in the operating microscope's video."|At time of surgery-Time (minutes/seconds) from first clip to contact aneurysm to final clip placement|Data was lost; no results can be reported|||||
648619|NCT02099318|Primary|Aneurysm Clip Time|"Number of Clipping attempts:
Applying a clip (i.e., closing a clip on the aneurysm)
Removing a clip (i.e., a clip was applied on the aneurysm and then removed)
Adjusting a clip (i.e., the clip was applied on the aneurysm and then opened, adjusted, and closed again)."|At time of surgery-Time (minutes/seconds) from first clip attempt to final clip position(up to 5 minutes)|Data was lost; no results can be reported|||||
648620|NCT02099266|Secondary|Proportion of Reduced Intensity Conditioning Participants With Complete Engraftment.|Complete engraftment is defined as as marrow reconstitution of greater than 90% of donor cells. Degree of engraftment will be determined through bone marrow chimerism assessment at either day 21 or day 28.|28 days|||Participants|||Count of Participants
648621|NCT02099266|Secondary|Determine the Effects of HBO Therapy on Neutrophil Count Recovery.|Time in days until neutrophil count recovery is achieved; neutrophil count recovery is defined as three consecutive days of achieving a neutrophil level >/= 500 u/L.|Daily measurement of neutrophil counts up to 90 days post transplant.|||Days||Full Range|Median
648622|NCT02099266|Primary|Safety of HBO Administration in the Setting of UCB Stem Cell Transplantation|Treatment limiting toxicities are defined as the occurrence of any of the following complications within 24hrs of treatment: pneumothorax, death, irreversible grade III or any grade IV toxicity that is determined by the treating physician to be related to HBO therapy.|Toxicity assessment with 24hrs of treatment|One patient treatment was shortened by approximately 10 minutes because of nausea attributed to concomitant medications.||Participants|||Count of Participants
648623|NCT02099084|Other Pre-specified|Urine Volume at 8 Hours|After an overnight fast, subjects received a single dose of placebo or Teduglutide 1 hour before breakfast, then consumed a radiolabeled meal. Urine was collected twice: from the start of the ingestion of the meal to 2 hours, and 2-8 hours. The total volume of urine collected was the sum of these two collections.|Start of the ingestion of the radiolabeled meal until 8 hours after the meal|||mL||Standard Deviation|Mean
648624|NCT02099084|Other Pre-specified|Stool Weight at 8 Hours|After an overnight fast, subjects received a single dose of placebo or Teduglutide 1 hour before breakfast, then consumed a radiolabeled meal. After 8 hours a stool collection was taken.|approximately 8 hours after ingestion of radiolabeled meal|||g||Standard Deviation|Mean
648625|NCT02099084|Secondary|Change in Small Intestinal and Colonic Permeability as Measured by Lactulose/Mannitol Ratio at 2 Hours|Permeability is measured through differential excretion of urine saccharides. A sugar solution (200 mg of mannitol and 1 g lactulose in 30 mL of water) was administered with the radiolabeled test meal at visits 1 and 2. Urine was collected during 0-2 and 2-8 hours. A baseline urine sample was also collected prior to ingestion of the sugars. Chemical analysis was preformed with high-speed liquid chromatography tandem mass spectrometry.|baseline, approximately 2 hours after ingestion of radiolabeled meal|||ratio||Standard Deviation|Mean
648626|NCT02099084|Secondary|Change in Small Intestinal and Colonic Permeability as Measured by Urinary Excretion of Lactulose at 2 Hours|Permeability is measured through differential excretion of urine saccharides. A sugar solution (200 mg of mannitol and 1 g lactulose in 30 mL of water) was administered with the radiolabeled test meal at visits 1 and 2. Urine was collected during 0-2 and 2-8 hours. A baseline urine sample was also collected prior to ingestion of the sugars. Chemical analysis was preformed with high-speed liquid chromatography tandem mass spectrometry.|baseline, approximately 2 hours after ingestion of radiolabeled meal|||mg||Standard Deviation|Mean
648642|NCT02098733|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|Tabulated the changes from baseline in glycosylated hemoglobin (HbA1c) values at each test time point (test value at each test time point after baseline - test value at baseline). A negative change from Baseline indicates improvement.|Baseline, and Months 3, 6, 9, 12 and at Final Assessment|All enrolled participants with data available.||percentage of glycosylated haemoglobin||Standard Deviation|Mean
648627|NCT02099084|Primary|Overall Gut Transit|Given the variable extent of the residual length of the small intestine and colon, the proportion emptied from the body at 6 hours was assessed as an overall estimate of the whole gut transit. The 6-hour values for intra-abdominal counts were then compared with the 100% reference values of counts (at time zero, which is immediately after ingestion of the radiolabeled meal) to determine the percentage of isotope retained in the abdomen. 100% minus the percentage of retained isotope reflected the amount emptied from the GI tract.|baseline, approximately 6 hours after ingestion of radiolabeled meal|||Percentage of isotope emptied||Standard Deviation|Mean
648628|NCT02099084|Secondary|Change in Small Intestinal and Colonic Permeability as Measured by Urinary Excretion of Mannitol|Permeability is measured through differential excretion of urine saccharides. A sugar solution (200 mg of mannitol and 1 g lactulose in 30 mL of water) was administered with the radiolabeled test meal at visits 1 and 2. Urine was collected during 0-2 and 2-8 hours. A baseline urine sample was also collected prior to ingestion of the sugars. Chemical analysis was preformed with high-speed liquid chromatography tandem mass spectrometry.|baseline, approximately 2 hours and 8 hours after ingestion of radiolabeled meal|||mg||Standard Error|Mean
648629|NCT02099084|Primary|Gastric Emptying Half-Time (T1/2)|The time for half of the ingested solids or liquids to leave the stomach.|approximately 2 hours after radiolabeled meal is ingested|||minutes||Standard Deviation|Mean
648630|NCT02099006|Secondary|Reduction in Tampon Test Pain|"Reduction in the pain, as measured on a 10 point Likert scale, associated with the insertion and removal of a tampon. This is a validated surrogate for pain associated with intercourse. Subjects were asked to insert and remove a tampon each week and report the degree of pain associated with this. A score of 0 was defined as no pain, and a score of 10 was defined as worst imaginable pain."|13 weeks|For each placebo entry the data is limited to include only those participates who also received the named intervention.||units on a scale||Standard Deviation|Mean
648631|NCT02099006|Primary|Reduction in Daily Genital Pain.|"Each subject was asked to keep a symptom diary recording her daily genital pain, measured on a 10 point Likert scale. A score of 0 was defined as no pain and a score of 10 was defined as worst imaginable pain. These daily values were collected and a mean pain score for the period of treatment was calculated."|13 weeks|For each placebo entry the data is limited to include only those participates who also received the named intervention.||units on a scale||Standard Deviation|Mean
648632|NCT02098746|Primary|Frequency of Serious Adverse Drug Reactions|Frequency of serious adverse drug reactions is defined at the number of participants with serious adverse drug reactions. Frequency of serious adverse drug reactions were tabulated by each symptom. Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.|12 months|The Safety Analysis Set (safety assessment population) included all patients who received at least one dose of pioglitazone/glimepiride (N=289).||participants|||Number
648633|NCT02098746|Secondary|Change From Baseline in Fasting Insulin Level|Tabulation of fasting insulin level and the changes from Baseline at each test time point (test value at each test time point after Baseline – test value at Baseline). A negative change from Baseline indicates improvement. A positive change from Baseline indicates a worsening.|Baseline, Months 3, 6, 9, 12 and at Final assessment|The analysis was performed on the efficacy assessment population (N=250) with data available at the given time-point.||μU/dL||Standard Deviation|Mean
648634|NCT02098746|Secondary|Change From Baseline in Fasting Blood Glucose Level|Tabulation of fasting blood glucose level and the changes from Baseline at each test time point (test value at each test time point after Baseline – test value at Baseline). A negative change from Baseline indicates improvement.|Baseline, Months 3, 6, 9, 12 and at Final assessment|The analysis was performed on the efficacy assessment population (N=250) with data available at the given time-point.||mg/dL||Standard Deviation|Mean
648635|NCT02098746|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|Tabulation of HbA1c values and the changes from Baseline at each test time point (test value at each test time point after Baseline – test value at Baseline). A negative change from Baseline indicates improvement.|Baseline, Months 3, 6, 9, 12 and at Final assessment|The analysis was performed on the efficacy assessment population (N=250) with data available at the given time-point.||percent||Standard Deviation|Mean
648636|NCT02098746|Primary|Frequency of Adverse Drug Reactions|Frequency of adverse drug reactions is defined as the number of participants with adverse drug reactions. Frequency, seriousness, and time to onset of adverse drug reactions were tabulated by each symptom. Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.|12 months|The Safety Analysis Set (safety assessment population) included all patients who received at least one dose of pioglitazone/glimepiride (N=289).||participants|||Number
648637|NCT02098733|Secondary|Fasting Insulin Level|Tabulated fasting insulin level at each test time point.|Baseline, Months 3, 6, 9, 12 and at Final Assessment|All enrolled participants with data available.||μU/dL||Standard Deviation|Mean
648638|NCT02098733|Secondary|Change From Baseline in Fasting Insulin Level|Tabulated the changes from baseline at each test time point (test value at each test time point after baseline – test value at baseline). A negative change from Baseline indicates improvement.|Baseline, Months 3, 6, 9, 12 and at Final Assessment|All enrolled participants with data available.||μU/dL||Standard Deviation|Mean
648639|NCT02098733|Secondary|Fasting Blood Glucose Level|Tabulated fasting blood glucose level from baseline at each test time point.|Baseline, Months 3, 6, 9, 12 and at Final Assessment|All enrolled participants with data available.||mg/dL||Standard Deviation|Mean
648640|NCT02098733|Secondary|Change From Baseline in Fasting Blood Glucose Level|Tabulated the changes from baseline in fasting blood glucose level at each test time point (test value at each test time point after baseline - test value at baseline). A negative change from Baseline indicates improvement.|Baseline, Months 3, 6, 9, 12 and at Final Assessment|All enrolled participants with data available.||mg/dL||Standard Deviation|Mean
648643|NCT02098733|Primary|Number of Participants With Adverse Drug Reactions|Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.|For 12 months|All enrolled participants with available data.||participants|||Number
648644|NCT02098395|Secondary|Number of Treatment-emergent Symptomatic Hypoglycaemic Episodes|Number of treatment-emergent symptomatic hypoglycaemic episodes during 26 weeks of treatment. Symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the American Diabetes Association (ADA) classification or a self-measured plasma glucose (SMPG) value of <3.1 mmol/L (56 mg/dL), with symptoms consistent with hypoglycaemia. Severe hypoglycaemia as per ADA classification is defined as an episode that required assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions.|Weeks 0-26|Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo (SAS = 832 subjects). Symptomatic hypoglycaemic episodes were reported by 166 subjects in liraglutide 0.6 mg arm, 175 subjects in liraglutide 1.2 mg, 160 subjects in liraglutide 1.8 mg arm and 162 subjects in liraglutide placebo arm.||episodes|||Number
648645|NCT02098395|Secondary|Change From Baseline in Body Weight|Change from baseline body weight, after 26 weeks of treatment. Full analysis set (FAS = 831) included all randomised subjects who had received at least one dose and had any post-randomisation data.|Week 0, Week 26|Of the 831 subjects in FAS, 27 subjects in lira 0.6 mg arm, 38 subjects in lira 1.2 mg arm, 35 subjects in lira 1.8 mg arm and 26 in placebo arm did not contribute to the analysis. Missing data imputed from a mixed model for repeated measurements (MMRM) method.||kg||Standard Deviation|Mean
648646|NCT02098395|Primary|Change From Baseline in Glycosylated Haemoglobin (HbA1c)|Change from baseline in glycosylated haemoglobin (HbA1c), after 26 weeks of treatment. Full analysis set (FAS = 831) included all randomised subjects who had received at least one dose and had any post-randomisation data.|Week 0, Week 26|Out of the 831 subjects in FAS, 22 subjects in lira 0.6 mg arm, 33 subjects in lira 1.2 mg arm, 35 subjects in lira 1.8 mg arm and 16 in placebo arm did not contribute to this analysis. Missing data imputed from a mixed model for repeated measurements (MMRM) method.||Percent (%) glycosylated haemoglobin||Standard Deviation|Mean
648647|NCT02098304|Secondary|User Experience|Completion of User Questionnaires after imaging with the Calcivis System|0 day|User Questionnaires comprised nine questions and users were asked to tick the most appropriate response i.e. extremely easy, easy etc. No numerical values were assigned to the responses.||User questionnaires|||Number
648648|NCT02098304|Secondary|Patient Experience|Completion of Patient Questionnaires after imaging with the Calcivis System|Day 0|Patient Questionnaires comprised five questions and the patient was asked to tick the most appropriate response i.e very good, good etc. No numerical values were assigned to the responses||Patient Questionnaires|Participants||Number
648649|NCT02098304|Primary|Measure Safety of the Calcivis Caries Imaging System|Collection of all adverse events recorded and reported throughout the duration of the study|Day 0 and Day 7|Adverse events||adverse events|||Number
648650|NCT02098304|Primary|Percentage Agreement of Sound/Unsound Teeth Between ICDAS Score and Calcivis System|% agreement calculated as no. of teeth where ICDAS assessment & Calcivis System assessment is in agreement/total number of teeth assessed multiplied by 100. Agreement defined as a sound tooth without luminescence & an unsound tooth with luminescence.|Day 0|All 42 patients recruited are included in the Safety Population, which included any subjects on whom the Calcivis System was used. 31 patients are included in the Agreement Population which included all subjects with at least one tooth with an eligible image. From the 31 patients, 65 teeth were analysed; in some patients multiple teeth were imaged.||percentage agreement|Participants|95% Confidence Interval|Number
648651|NCT02098109|Secondary|Comparison of the Percentage of Patients Who Collect > 5.0x10^6 CD34+Cells/kg in One Apheresis Procedure Following PBSC Mobilization Between the Two Arms||Day 5|||percentage of participants|||Number
648652|NCT02098109|Secondary|Comparison of the Percentage of Patients Who Collect > 2.0x10^6 CD34+Cells/kg in One Apheresis Procedure Following PBSC Mobilization Between the Two Arms||Day 5|||percentage of participants|||Number
648653|NCT02098109|Secondary|Comparison of the Percentage of Patients Who Collect > 5.0x10^6 CD34+Cells/kg Following PBSC Mobilization Between the Two Arms||Up to Day 8 (total collection)|||percentage of participants|||Number
648654|NCT02098109|Secondary|Comparison of the Percentage of Patients Who Collect > 2.0x10^6 CD34+Cells/kg Following PBSC Mobilization Between the Two Arms||Up to Day 8 (total collection)|||percentage of participants|||Number
648655|NCT02098109|Secondary|Comparison of the Readmission Rate Between the Two Arms|Readmission rate is defined as the frequency at which patients are readmitted (after initial post-transplant discharge) following post-infusion of mobilized PBSC product for reasons other than progressive disease/relapse|Up to Day 100|(2) participants in the XM02 Filgrastim (Granix) & Plerixafor arm did not receive ASCT and were not evaluable for this outcome measure. (1) participant in the Filgrastim (Neupogen) & Plerixafor arm did not receive ASCT and were not evaluable for this outcome measure.||Participants|||Count of Participants
648656|NCT02098109|Secondary|Comparison of the Time to Platelet Engraftment Between the Two Arms|Time to platelet engraftment is measured by determining the first of 3 consecutive measurements of platelet count ≥ 50,000/µl without platelet transfusion support for 7 days. Patients who do not have platelet engraftment by Day 100 post-infusion of mobilized PBSC product will be considered a platelet engraftment failure.|Up to Day 100|(2) participants in the XM02 Filgrastim (Granix) & Plerixafor arm did not receive ASCT and were not evaluable for this outcome measure. (1) participant in the Filgrastim (Neupogen) & Plerixafor arm did not receive ASCT and were not evaluable for this outcome measure.||days||95% Confidence Interval|Median
648657|NCT02098109|Secondary|Comparison of the Time to Neutrophil Engraftment Between the Two Arms|Time to neutrophil engraftment is measured by determining the first of 3 consecutive measurements of neutrophil count ≥ 500/µl following conditioning regimen-induced nadir. Patients who do not have neutrophil engraftment by Day 30 post-infusion of mobilized PBSC product will be considered a neutrophil engraftment failure.|Up to Day 30 post-infusion|(2) participants in the XM02 Filgrastim (Granix) & Plerixafor arm did not receive ASCT and were not evaluable for this outcome measure. (1) participant in the Filgrastim (Neupogen) & Plerixafor arm did not receive ASCT and were not evaluable for this outcome measure.||days||95% Confidence Interval|Median
648661|NCT02097849|Secondary|Number of Participants With Abnormalities in Vital Signs|Temperature increase: > 38 celcius (C) or ≥ 1 C increase from baseline. Pulse increase: > 120 beats per minute (bpm) or > 20 bpm increase from baseline. Pulse decrease: < 50 bpm or > 20 bpm decrease from baseline. Systolic blood pressure (SBP) increase: > 180 millimeters of mercury (mmHg) or > 40 mmHg from baseline. SBP decrease: < 90 mmHg or > 30 mmHg decrease from baseline. Diastolic blood pressure (DBP) increase: > 105 mmHg or > 30 mmHg increase from baseline. DBP decrease: < 50 mmHg or > 20 mmHg decrease from baseline.|Screening to Week 4|Participants who had a baseline assessment and at least one postbaseline assessment.||participants|||Number
648662|NCT02097849|Secondary|Number of Participants With Shifts From Baseline in Blood Chemistry|Shift to low includes normal to low, high to low, and unknown to low. Shift to high includes normal to high, low to high, and unknown to high.|Screening to Week 4|n=participants whose baseline value was not low (or high) and who had at least one postbaseline value.||participants|||Number
648663|NCT02097849|Secondary|Number of Participants With Shifts From Baseline in Hematology|Shift to low includes normal to low, high to low, and unknown to low. Shift to high includes normal to high, low to high, and unknown to high.|Screening to Week 4|n=participants whose baseline value was not low (or high) and who had at least one postbaseline value.||participants|||Number
648664|NCT02097849|Secondary|Number of Participants Experiencing Vaccination-Emergent Adverse Events (AEs) and Serious AEs|An AE was any untoward medical occurrence that did not necessarily have a causal relationship with this treatment. A serious AE was any untoward medical occurrence that at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigator, could have jeopardized the participant or required intervention to prevent one of the other outcomes listed in the definition above.|Day 1 to Week 4|Participants who received at least one vaccination.||participants|||Number
648665|NCT02097849|Secondary|Ratio of Serum Meningococcal Antibodies (Serogroup C) Level at Day 28 to Prevaccination|Median serum titer ratios from prevaccination to 4 weeks after MCV4 vaccination.|Up to Week 4 (Day 28) postvaccination|One participant in the IFN group did not have an assessment.||ratio||Inter-Quartile Range|Median
648666|NCT02097849|Secondary|Ratio of Serum Pneumococcal Antibodies (Serotype 8) Level at Day 28 to Prevaccination|Median serum titer ratios from prevaccination to 4 weeks after PPSV23 vaccination.|Up to Week 4 (Day 28) postvaccination|||ratio||Inter-Quartile Range|Median
648667|NCT02097849|Secondary|Ratio of Serum Pneumococcal Antibodies (Serotype 3) Level at Day 28 to Prevaccination|Median serum titer ratios from prevaccination to 4 weeks after PPSV23 vaccination.|Up to Week 4 (Day 28) postvaccination|||ratio||Inter-Quartile Range|Median
648668|NCT02097849|Secondary|Ratio of Serum Tetanus Level at Day 28 to Prevaccination|Median serum titer ratios from prevaccination to 4 weeks after Td vaccination.|Up to Week 4 (Day 28) postvaccination|||ratio||Inter-Quartile Range|Median
648669|NCT02097849|Secondary|Percentage of Meningococcal Serogroup C Responders (≥ 4-Fold Rise) Compared to Prevaccination Level|Percentage of participants with a ≥ 4-fold rise in anti-meningococcal serum IgG levels against serotype C from prevaccination to 4 weeks after MCV4 vaccination.|Up to Week 4 (Day 28) postvaccination|One participant in the IFN group did not have an assessment.||percentage of participants||95% Confidence Interval|Number
648670|NCT02097849|Secondary|Percentage of Meningococcal Serogroup C Responders (≥ 2-Fold Rise) Compared to Prevaccination Level|Percentage of participants with a ≥ 2-fold rise in anti-meningococcal serum IgG levels against serotype C from prevaccination to 4 weeks after MCV4 vaccination.|Up to Week 4 (Day 28) postvaccination|One participant in the IFN group did not have an assessment.||percentage of participants||95% Confidence Interval|Number
648671|NCT02097849|Secondary|Percentage of Pneumococcal Serotype 8 (≥ 4-Fold Rise) Responders Compared to Prevaccination Level|Percentage of participants with a ≥ 4-fold rise in anti-pneumococcal serum IgG levels against serotype 8 from prevaccination to 4 weeks (28 days) after PPSV23 vaccination.|Up to Week 4 (Day 28) postvaccination|||percentage of participants||95% Confidence Interval|Number
648672|NCT02097849|Secondary|Percentage of Pneumococcal Serotype 8 (≥ 2-Fold Rise) Responders Compared to Prevaccination Level|Percentage of participants with a ≥ 2-fold rise in anti-pneumococcal serum IgG levels against serotype 8 from prevaccination to 4 weeks (28 days) after PPSV23 vaccination.|Up to Week 4 (Day 28) postvaccination|||percentage of participants||95% Confidence Interval|Number
648673|NCT02097849|Secondary|Percentage of Pneumococcal Serotype 3 (≥ 4-Fold Rise) Responders Compared to Prevaccination Level|Percentage of participants with a ≥ 4-fold rise in anti-pneumococcal serum IgG levels against serotype 3 from prevaccination to 4 weeks (28 days) after PPSV23 vaccination.|Up to Week 4 (Day 28) postvaccination|||percentage of participants||95% Confidence Interval|Number
648674|NCT02097849|Secondary|Percentage of Pneumococcal Serotype 3 (≥ 2-Fold Rise) Responders Compared to Prevaccination Level|Percentage of participants with a ≥ 2-fold rise in anti-pneumococcal serum IgG levels against serotype 3 from prevaccination to 4 weeks (28 days) after PPSV23 vaccination.|Up to Week 4 (Day 28) postvaccination|||percentage of participants||95% Confidence Interval|Number
648675|NCT02097849|Secondary|Percentage of Tetanus Responders (≥ 4-Fold Rise) at Day 28 Compared to Prevaccination Level|Percentage of participants with a ≥ 4-fold rise in anti-tetanus serum IgG levels (responders) from prevaccination to 4 weeks after Td vaccination.|Up to Week 4 (Day 28) postvaccination|||percentage of participants||95% Confidence Interval|Number
648676|NCT02097849|Primary|Percentage of Tetanus Responders (≥ 2-Fold Rise) at Day 28 Compared to Prevaccination Level|Percentage of participants with a ≥ 2-fold rise in anti-tetanus serum immunoglobulin G (IgG) levels (responders) from prevaccination to 4 weeks after Td vaccination.|Up to Week 4 (Day 28) postvaccination|||percentage of participants||95% Confidence Interval|Number
648677|NCT02097823|Other Pre-specified|Number of Participants With Adverse Events.|Olanzapine will be considered tolerable if less than 10% of patients experience a grade III or IV adverse event attributable to olanzapine.|Ongoing, throughout the study. Will be fully evaluated in approximately 1 year, at the conclusion of data collection. Each patient will be followed during 2 cycles of chemotherapy, an expected average of 6 weeks.|||participants|||Number
649052|NCT02092441|Primary|Nausea Verbal Numerical Rating Scale (0-10) at 10 Minutes Post Intervention|"Primary outcome is nausea and vomiting measured on a scale from 0 (no nausea) to 10 (worst nausea imaginable) Verbal Numerical Response Scale (VNRS) at 10 minutes post intervention."|10 minutes post intervention|||VNRS||Inter-Quartile Range|Median
648678|NCT02097823|Secondary|Good Control of Nausea|"Good control of nausea will be ratings <25 on visual analog scale by parents and <2 on baxter retching faces scale by patients. Will look at the proportions of patients with good control of nausea.
The visual analog scale ranged from 0-100, with 0 being no nausea and 100 being very very severe nausea. The Baxter retching faces scale ranged from 0-10 using only even numbers (0,2,4,6,8,10) and each number has a corresponding face depicting someone experiencing varying levels of nausea, with 0 being no nausea and 10 being a picture of face vomiting."|Participants will be followed during 2 cycles of chemotherapy, an expected average of 6 weeks. Data will be collected over 5 days during each cycle.|could only analyze cycles where subjects had returned completed forms||percentage of participant w/good control|||Number
648679|NCT02097823|Secondary|Complete Response in Delayed Phase|This will measure what percentage of patients have a complete response (no emesis or use of breakthrough medications) in the delayed phase (25-120 hours).|Participants will be followed during 2 cycles of chemotherapy, an expected average of 6 weeks. Data will be collected over 5 days during each cycle.|||percentage of participants with CR|||Number
648680|NCT02097823|Secondary|Complete Response in Acute Phase|This will measure what percentage of patients have a complete response (no emesis or use of breakthrough medications) in the acute phase (0-24 hours).|Participants will be followed during 2 cycles of chemotherapy, an expected average of 6 weeks. Data will be collected over 5 days during each cycle.|||percentage of participants with CR|||Number
648681|NCT02097823|Secondary|Complete Response in Overall Phase|This will measure what percentage of patients have a complete response (no emesis or use of breakthrough medications) in the overall phase (0-120 hours).|Participants will be followed during 2 cycles of chemotherapy, an expected average of 6 weeks. Data will be collected over 5 days during each cycle.|||percentage of participants with CR|||Number
648682|NCT02097823|Primary|Feasibility of Recruitment and Data Collection.|Primary objective of this study is to determine the feasibility of recruitment and data collection for conducting a larger trial. Recruitment and data collection will be feasible if at least 20 subjects can be recruited in 1 year and there is a 90% form completion rate.|Approximately 1 year after study opens, at the conclusion of data collection. Participants will be followed during 2 cycles of chemotherapy, an expected average of 6 weeks. Data will be collected over 5 days during each cycle.|||percentage of completed forms|Administered forms||Number
648683|NCT02097745|Secondary|Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Year 5|The HAQ-DI is a questionnaire specific for rheumatoid arthritis and consists of 20 questions referring to 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Participants completed the questionnaire by answering the 20 questions on a scale of 0 (without difficulty) to 3 (unable to do). The total score ranges from 0 (no disability) to 3 (completely disabled). A negative change score indicates improvement. Data is reported for 2 groups.|Baseline to Year 5|Intent-to-treat population: All participants who received any part of an infusion of study medication in study WA17531. Only participants who had radiographs available at Baseline and Year 5 were included in the analysis.||Units on a scale||Standard Deviation|Mean
648684|NCT02097745|Secondary|Change From Baseline in the Genant-modified Sharp Joint Space Narrowing Score at Year 5|The Genant-modified Sharp scoring system assesses structural damage due to rheumatoid arthritis in radiographs. A score joint space narrowing of 0-4 (9 gradations) is assigned to 13 joints in each hand and 6 joints in each foot. The maximum joint space narrowing score is 38 x 4.0 = 152 which is normalized to a score of 145. The minimum score is 0 and the maximum score is 145. A higher score indicates more damage. A negative change score indicates improvement. Data is reported for 2 groups.|Baseline to Year 5|Intent-to-treat population: All participants who received any part of an infusion of study medication in study WA17531. Only participants who had radiographs available at Baseline and Year 5 were included in the analysis.||Units on a scale||Standard Deviation|Mean
648685|NCT02097745|Secondary|Change From Baseline in the Genant-modified Sharp Erosion Score at Year 5|The Genant-modified Sharp scoring system assesses structural damage due to rheumatoid arthritis in radiographs. A score for erosions of 0-3.5 (8 gradations) is assigned for 14 joints in each hand and wrist, and 6 joints in each foot. The maximum erosion score is 40 x 3.5 = 140 which is normalized to 145. The minimum score is 0 and the maximum score is 145. A higher score indicates more damage. A negative change score indicates improvement. Data is reported for 2 groups.|Baseline to Year 5|Intent-to-treat population: All participants who received any part of an infusion of study medication in study WA17531. Only participants who had radiographs available at Baseline and Year 5 were included in the analysis.||Units on a scale||Standard Deviation|Mean
648686|NCT02097745|Secondary|Change From Baseline in the Total Genant-modified Sharp Score at Year 5|The Genant-modified Sharp scoring system assesses structural damage due to rheumatoid arthritis in radiographs. A score for erosions of 0-3.5 (8 gradations) is assigned for 14 joints in each hand and wrist, and 6 joints in each foot. Joint space narrowing scores of 0-4 (9 gradations) are assigned to 13 joints in each hand and 6 joints in each foot. The maximum erosion score is 40 x 3.5 = 140. The maximum joint space narrowing score is 38 x 4.0 = 152. Both the erosion and joint space narrowing scores are normalized to 145 and are added together for a maximum total Genant-modified Sharp score of 290; the minimum score is 0. A higher score indicates more damage. A negative change score indicates improvement. Data is reported for 2 groups.|Baseline to Year 5|Intent-to-treat population: All participants who received any part of an infusion of study medication in study WA17531. Only participants who had radiographs available at Baseline and Year 5 were included in the analysis.||Units on a scale||Standard Deviation|Mean
648687|NCT02097745|Secondary|Percentage of Participants With no Radiographic Progression From Baseline to Year 5|Radiographic progression was defined as a change of ≤ 0 in the total Genant-modified Sharp score. The Genant-modified Sharp scoring system assesses structural damage due to rheumatoid arthritis in radiographs. A score for erosions of 0-3.5 (8 gradations) is assigned for 14 joints in each hand and wrist, and 6 joints in each foot. Joint space narrowing scores of 0-4 (9 gradations) are assigned to 13 joints in each hand and 6 joints in each foot. The maximum erosion score is 40 x 3.5 = 140. The maximum joint space narrowing score is 38 x 4.0 = 152. Both the erosion and joint space narrowing scores are normalized to 145 and are added together for a maximum total Genant-modified Sharp score of 290; the minimum score is 0. A higher score indicates more damage. Data is reported for 2 groups.|Baseline to Year 5|Intent-to-treat population: All participants who received any part of an infusion of study medication in study WA17531. Only participants who had radiographs available at Baseline and Year 5 were included in the analysis.||Percentage of participants||95% Confidence Interval|Number
648688|NCT02097745|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score|The FACIT-F is a 13-item participant self-reporting questionnaire that assesses fatigue over the previous 7 days by scoring each item on a 5-point scale (0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit, 4=Very much). An overall FACIT-F score was obtained by summing the scores of all 13 items. The overall score ranged from 0 to 52. A lower score indicates less fatigue. A negative change score indicates improvement.|Baseline to the end of the retreatment period (up to 7 years, 6 months)|Intent-to-treat population: All participants who received any part of an infusion of study medication in study WA17531.||Units on a scale||Standard Deviation|Mean
648689|NCT02097745|Secondary|Change From Baseline in the Physical and Mental Component Scores of the Short Form 36 (SF-36) Health Survey|The SF-36 Health Survey uses patient-reported symptoms on 8 subscales to assess health-related quality of life (HRQoL). The Physical Component Summary (PCS) score summarizes the subscales Physical Functioning, Role-Physical, Bodily Pain, and General Health. The Mental Component Summary (MCS) score summarizes the subscales Vitality, Social Functioning, Role-Emotional, and Mental Health. Each score was scaled from 0 to 100 with a higher score indicating better HRQoL. A positive change score indicates an improvement in HRQoL.|Baseline to the end of the retreatment period (up to 7 years, 6 months)|Intent-to-treat population: All participants who received any part of an infusion of study medication in study WA17531.||Units on a scale||Standard Deviation|Mean
648690|NCT02097745|Secondary|Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score|The HAQ-DI is a questionnaire specific for rheumatoid arthritis and consists of 20 questions referring to 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Participants completed the questionnaire by answering the 20 questions on a scale of 0 (without difficulty) to 3 (unable to do). The total score ranges from 0 (no disability) to 3 (completely disabled). A negative change score indicates improvement.|Baseline to the end of the retreatment period (up to 7 years, 6 months)|Intent-to-treat population: All participants who received any part of an infusion of study medication in study WA17531.||Units on a scale||Standard Deviation|Mean
648691|NCT02097745|Secondary|Change From Baseline in the American College of Rheumatology n (ACRn) Response|The ACRn response was defined as each participant’s least favorable percentage change from Baseline in 3 measures, tender joint count, swollen joint count (28 assessed joints), and improvement score achieved in at least 3 of the 5 remaining ACR parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, left end=no disease activity, right end=maximum disease activity; patient assessment of pain in previous 24 hours on a VAS (left end=no pain, right end=unbearable pain); Health Assessment Questionnaire-Disability Index (20 questions, 8 components, 0=without difficulty to 3=unable to do); and acute-phase reactant (either C-reactive protein or erythrocyte sedimentation rate). A higher change percentage indicates greater improvement from Baseline. The ACRn response was compared to Baseline in the precursor study WA17042. The first retreatment may have occurred in the precursor study WA17042.|Baseline to the end of the retreatment period (up to 7 years, 6 months)|Intent-to-treat population: All participants who received any part of an infusion of study medication in study WA17531.||Percentage change||Standard Deviation|Mean
648692|NCT02097745|Secondary|Percentage of Participants With Good, Moderate, or no European League Against Rheumatism (EULAR) Responses|Change of the Disease Activity Score 28 score from baseline was used to determine EULAR responses of good, moderate, or no response. For a post-baseline score ≤ 3.2, a change from baseline of < -1.2 was a good response, < -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-baseline score > 3.2 to ≤ 5.1, a change from baseline of < -0.6 was a moderate response and ≥ -0.6 was no response. For a post-baseline score > 5.1, a change from baseline < -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-baseline scores > 3.2. The first retreatment may have occurred in the precursor study WA17042.|Baseline to the end of the retreatment period (up to 7 years, 6 months)|Intent-to-treat population: All participants who received any part of an infusion of study medication in study WA17531.||Percentage of participants|||Number
648693|NCT02097745|Secondary|Percentage of Participants With DAS28 Low Disease Activity and DAS28 Remission|The DAS28 is an index for measuring disease activity in rheumatic arthritis and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient’s global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. Low disease activity was defined as a DAS28 score ≤ 3.2. DAS28 remission was defined as a DAS28 score < 2.6. The first retreatment may have occurred in the precursor study WA17042.|Baseline to the end of the retreatment period (up to 7 years, 6 months)|Intent-to-treat population: All participants who received any part of an infusion of study medication in study WA17531.||Percentage of participants|||Number
648694|NCT02097745|Secondary|Change From Baseline in the Disease Activity Score 28 (DAS28)|The DAS28 is an index for measuring disease activity in rheumatic arthritis and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient’s global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where a higher score represents higher disease activity. A negative change score indicates improvement. The first retreatment may have occurred in the precursor study WA17042.|Baseline to the end of the retreatment period (up to 7 years, 6 months)|Intent-to-treat population: All participants who received any part of an infusion of study medication in study WA17531.||Units on a scale||Standard Deviation|Mean
649053|NCT02092415|Primary|Muscle Perfusion|Contrast ultrasound perfusion imaging will be performed at baseline and 1 min after application of the JT.|baseline and 1 min post occlusion|||IU/s||Standard Error|Mean
648695|NCT02097745|Primary|Percentage of Participants With an American College of Rheumatology 20 (ACR20) Response|A patient had an ACR20 response if there was at least a 20% improvement, ie, reduction from Baseline, in tender and swollen joint counts (28 assessed joints) and in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, left end=no disease activity [symptom-free and no arthritis symptoms], right end=maximum disease activity; patient assessment of pain in previous 24 hours on a VAS (left end=no pain and right end=unbearable pain); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and acute-phase reactant (either C-reactive protein or erythrocyte sedimentation rate). The ACR20 response was compared to Baseline in the precursor study WA17042. The first retreatment may have occurred in the precursor study WA17042.|Baseline to the end of the retreatment period (up to 7 years, 6 months)|Intent-to-treat population: All participants who received any part of an infusion of study medication in study WA17531.||Percentage of participants|||Number
648696|NCT02097719|Primary|Intraocular Pressure (IOP) in the Study Eye at 8 AM, 12 PM, and 4 PM|IOP is a measurement of the fluid pressure inside the eye. IOP of the study eye (worse eye) is measured at 8 AM, 12 PM, and 4 PM. IOP is either the average of 2 measurements, or, if a third measurement is required, the average of 3 measurements.|Week 12 at 8 AM, 12 PM, and 4 PM|Intent-to-Treat: all subjects who were randomized to study medication with data at the noted time point||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
648697|NCT02097537|Secondary|The Summary Statistics of PC20|PC20 : the concentration of methacholine causing 20% fall in FEV1.|Visit 1 (Day 1)|||mg/mL||Standard Deviation|Mean
648698|NCT02097537|Secondary|The Rate of Subjects Whose FEV1 Falls More Than 20% From Baseline Before the Highest Concentration Inhalation||Visit 1 (Day 1)|||percentage of the subjects|||Number
648699|NCT02097537|Primary|The Rate of Number of Subjects Whose PC20 is Less Than 8 mg/mL|"The methacholine challenge test is for assessment of bronchial sensitivity, it is assessed by FEV1 (Forced Expiratory Volume in one second) with spirometer.
For measurement of FEV1, a patient is inhaled saline as baseline and each dose of methacholine which be gradually diluted, inhalations are discontinued with a drop in FEV1 of 20% or more.
The concentration of methacholine causing 20% fall in FEV1 is PC20."|Visit 1 (Day 1)|||percentage of the subjects|||Number
648700|NCT02097290|Secondary|LVAT Secondary Efficacy Endpoint: The Percent of LVAT Commanded Tests That Result in an Appropriate Outcome|"This endpoint will evaluate the percent of LVAT commanded tests that result in an appropriate outcome. There are three possible outcomes to a commanded test:
A device-determined threshold
A threshold test code (indicating that a threshold could not be determined) representing an error condition that is beyond the control of the LVAT feature and could occur in the manual threshold tests
A threshold test code (indicating that a threshold could not be determined) that was due to a limitation of the LVAT feature and might not occur in manual threshold tests An appropriate LVAT outcome consists of the first two outcomes listed above: a device-determined threshold and a threshold test code representing an error condition that is beyond the control of the LVAT feature and could occur in the manual threshold tests. An inappropriate LVAT outcome consists of the last of the three outcomes listed above."|3-month follow up visit|A total of 182 unique subjects in whom a paired LVAT dataset was collected at the 3-month follow up visit. A paired dataset consisted of an LVAT threshold test outcome and core lab determined threshold test outcome.||percentage of appropriate outcome||95% Confidence Interval|Number
648701|NCT02097290|Secondary|RVAT Secondary Efficacy Endpoint: The Percent of RVAT Commanded Tests That Result in an Appropriate Outcome|"This endpoint will evaluate the percent of RVAT commanded tests that result in an appropriate outcome. There are three possible outcomes to a commanded test:
A device-determined threshold
A threshold test code (indicating that a threshold could not be determined) representing an error condition that is beyond the control of the RVAT feature and could occur in the manual threshold tests
A threshold test code (indicating that a threshold could not be determined) that was due to a limitation of the RVAT feature and might not occur in manual threshold tests An appropriate RVAT outcome consists of the first two outcomes listed above: a device-determined threshold and a threshold test code representing an error condition that is beyond the control of the RVAT feature and could occur in the manual threshold tests. An inappropriate RVAT outcome consists of the last of the three outcomes listed above."|3-month follow up visit|A total of 157 unique subjects in whom a paired RVAT dataset was collected at the 3-month follow up visit. A paired dataset consisted of an RVAT threshold test outcome and core lab determined threshold test outcome.||percentage of appropriate outcome||95% Confidence Interval|Number
648702|NCT02097290|Primary|The Accuracy of the LVAT Ambulatory Test Will be Evaluated by Comparing the LVAT Determined Threshold to a Core Lab (Independent Physician) Determined Threshold|"Accuracy of the algorithm will be measured for all patients, by comparing algorithm determined threshold to a core lab determined threshold at both the 1-month and 3-month follow-up visits. The LVAT determined threshold for all patients at 1-month and 3-month follow-up visits are pooled for final analysis. An accurate Ambulatory threshold is defined by: |Ambulatory threshold – ECG threshold| ≤ 1.0 V. Paired datasets from the 1-month and 3-month visits were pooled for the purpose of this endpoint analysis. Subjects were allowed to contribute multiple paired datasets for this endpoint analysis, one set each from the 1-month and 3-month visits. Paired datasets form the 1-month and 3-month visits were pooled for purposes of endpoint analysis."|1-month and 3-month follow up visits|A total of 300 paired datasets (from 175 unique subjects in whom LVAT threshold was available), each dataset consisting of a ambulatory LVAT threshold and a core lab determined threshold, were collected at the 1-month and 3- month visits and pooled for final analysis.||Percentage of accurate threshold|LVAT ambulatory threshold paired dataset|95% Confidence Interval|Number
648727|NCT02097030|Secondary|Overall Satisfaction, Handling|Participant’s subjective response for overall handling satisfaction. Measured after 3 days of daily disposable lens wear. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied.|3 Days|Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.||participants|||Number
648728|NCT02097030|Secondary|Overall Satisfaction, Comfort|Participant’s subjective response for overall comfort satisfaction. Measured after 3 days daily disposable wear of lenses. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied.|3 Days Follow-up|Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.||participants|||Number
648703|NCT02097290|Primary|The Accuracy of the RVAT Ambulatory Test Will be Evaluated by Comparing the RVAT Determined Threshold to a Core Lab (Independent Physician) Determined Threshold|"Accuracy of the algorithm will be measured for all patients, by comparing algorithm determined threshold to a core lab determined threshold at both the 1-month and 3-month follow-up visits.The RVAT determined threshold for all patients at 1-month and 3-month follow-up visits are pooled for final analysis. An accurate Ambulatory threshold is defined by:|Ambulatory threshold – ECG threshold| ≤ 0.6 V; if the ECG threshold is ≤ 3.5V or |Ambulatory threshold – ECG threshold| ≤ 1.0 V; if the ECG threshold is > 3.5V. Subjects were allowed to contribute multiple paired datasets for this endpoint analysis, one set each from the 1-month and 3-month visits. Paired datasets form the 1-month and 3-month visits were pooled for purposes of endpoint analysis."|1-month and 3-month follow up visits|A total of 314 paired datasets (from 183 unique subjects in whom RVAT threshold was available), each dataset consisting of an ambulatory RVAT threshold and a core lab determined threshold, were collected at the 1-month and 3- month visits and pooled for final analysis.||Percentage of RVAT ambulatory thresholds|RVAT ambulatory threshold paired dataset|95% Confidence Interval|Number
648704|NCT02097290|Primary|The Accuracy of the LVAT Commanded Test Will be Evaluated by Comparing the LVAT Determined Threshold to a Core Lab (Independent Physician) Determined Threshold.|"Accuracy of the algorithm will be measured for all patients, by comparing algorithm determined threshold to a core lab determined threshold at both the 1-month and 3-month follow-up visits. The LVAT determined threshold for all patients at 1-month and 3-month follow-up visits are pooled for final analysis. An accurate commanded threshold is defined by: commanded threshold – core lab determined threshold| ≤ 0.2 V; if the commanded threshold is ≤ 3.5V or |commanded threshold – core lab determined threshold| ≤ 0.5 V; if the commanded threshold is > 3.5V. Paired datasets from the 1-month and 3-month visits were pooled for the purpose of this endpoint analysis. Subjects were allowed to contribute multiple paired datasets for this endpoint analysis, one set each from the 1-month and 3-month visits. Paired datasets from the 1-month and 3-month visits were pooled for the purpose of this endpoint analysis."|1-month and 3-month follow up visits|A total of 324 paired datasets (from 182 unique subjects in whom LVAT threshold was available), each dataset consisting of a commanded LVAT threshold and a core lab determined threshold, were collected at the 1-month and 3- month visits and pooled for final analysis.||Percentage of commanded LVAT thresholds|Commanded LVAT thresholds-paired dataset|95% Confidence Interval|Number
648705|NCT02097290|Primary|The Accuracy of the RVAT Commanded Test Will be Evaluated by Comparing the RVAT Determined Threshold to a Core Lab (Independent Physician) Determined Threshold.|"Accuracy of the algorithm will be measured for all patients, by comparing algorithm determined threshold to a core lab determined threshold at both the 1-month and 3-month follow-up visits. The RVAT determined threshold for all patients at 1-month and 3-month follow-up visits are pooled for final analysis. An accurate commanded threshold is defined by: |commanded threshold – core lab determined threshold| ≤ 0.2 V; if the commanded threshold is ≤ 3.5V or |commanded threshold – core lab determined threshold| ≤ 0.5 V; if the commanded threshold is > 3.5V. Subjects were allowed to contribute multiple paired datasets for this endpoint analysis, one set each from the 1-month and 3-month visits. Paired datasets from the 1-month and 3-month visits were pooled for the purpose of this endpoint analysis."|1-month and 3-month follow-up visits|A total of 288 paired datasets (from 171 unique subjects in whom RVAT threshold was available), each dataset consisting of a commanded RVAT threshold and a core lab determined threshold, were collected at the 1-month and 3- month visits and pooled for final analysis.||percentage of commanded RVAT thresholds|Commanded RVAT thresholds paired dataset|95% Confidence Interval|Number
648706|NCT02097290|Primary|Primary Safety Endpoint is to Evaluate the System-related Complication-free Rate|Safety of the AUTOGEN was evaluated by the system-related complication-free rate (CFR) at 3-months post-implant. The system consists of the implanted AUTOGEN CRT-D pulse generator, RA lead (if implanted), RV lead, and LV lead.|3 months|Implant + Attempt Subjects||Percentage of participants||95% Confidence Interval|Number
648707|NCT02097238|Secondary|PK Parameters of Eribulin Mesylate|Data from all patients who provide samples for pharmacokinetic analysis will be aggregated. The sample mean and variance of the area under the curve, clearance and half-life will be calculated. The analytic unit for monitoring for excessive toxicity will be the patient-cycle: Each cycle where the patient receives eribulin and does not receive non-protocol anticancer therapy will be considered in the analysis.|Per Cycle Incidence of dose limiting toxicity.||12/2017||||
648708|NCT02097238|Secondary|Number of Cycles Where a Dose Limiting Toxicity Was Identified|Each cycle where the patient receives eribulin and does not receive nonprotocol anticancer therapy will be considered in the analysis. A dose limiting toxicity is defined to be: Day 8 eribulin dose is held due to Grade 3 or Grade 4 nonhematological toxicity attributable to the investigational drug and does not resolve to meet eligibility or baseline criteria by Day 11. Any ≥ Grade 3 nonhematological toxicity attributable to the investigational drug with the specific exclusion of: Grade 3 nausea and vomiting < 3 days duration Grade 3 liver enzyme elevation, including ALT/AST/GGT, that returns to Grade ≤ 1 or baseline prior to the time for the next treatment cycle.|39 cycles were considered for this analysis|19 patients were treated on protocol therapy. Thirty-nine cycles were reported for the analysis of dose limiting toxicity.||Cycle|Cycles||Number
648709|NCT02097238|Primary|RECIST Response|The number of patients who experience a complete or partial response according the the RECIST criteria as defined in Eisenhauer et al. Eur J Cancer 45:228-47, 2009.|First 5 cycles of protocol therapy|||participants|||Number
648710|NCT02097238|Primary|Disease Control Success|The number of patients who do not experience disease progression or death in the four months following enrollment on AOST1322.|Four Months following enrollment on the study|||participants|||Number
648711|NCT02097108|Secondary|High-density Lipoprotein (HDL) Cholesterol Baseline and After 24 Weeks||baseline to week 24|||mg/dl||Standard Deviation|Mean
648712|NCT02097108|Secondary|Triglycerides Baseline and After 24 Weeks||baseline to week 24|||mg/dl||Standard Deviation|Mean
648713|NCT02097108|Secondary|Total Cholesterol Baseline and After 24 Weeks||baseline to week 24|||mg/dl||Standard Deviation|Mean
648714|NCT02097108|Primary|Patients With Low-density Lipoprotein (LDL) Cholesterol Reduction|A reduction of > 5% in the plasma concentration of direct LDL cholesterol from baseline to week 12 or > 10% reduction of total cholesterol or reduction of lipid lowering agents is expected. Reduction of lipid lowering agents is defined as reduction due to amelioration of lipid profiles and does not include reduction due to side effects or other toxicity issues.|baseline to week 12|all patients||percentage of participants||95% Confidence Interval|Number
648715|NCT02097056|Secondary|Change From Baseline in the Neuropsychiatric Inventory Questionnaire (NPI-Q) Severity and Distress Total Scores|The NPI-Q assessed twelve behavioral domains common in dementia including; hallucinations, delusions, agitation/aggression, dysphoria/depression, anxiety, irritability, disinhibition, euphoria, apathy, aberrant motor behavior, sleep/night-time behavior change, and appetite/eating change. The questionnaire is given by the clinician to the patient’s caregiver who was asked if the behavior described is present in the patient. If “Yes”, the informant then rates both the Severity of the symptoms present within the last month on a 3-point scale (1 = mild, 2= moderate, and 3= severe) and the associated impact of the symptom manifestations on them (i.e. Caregiver Distress) using a 5-point scale (0 = not distressing at all, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, and 5 = extreme or very severe). The total severity score represents the sum of individual scores and ranges from 0 to 36. The total distress score represents the sum of individual symptom scores and ranges from 0 to 60.|Baseline, Week 12, and Week 24 (Follow up visit)|Efficacy analysis population included all participants who took at least one dose of study drug and had at least one baseline and at least one post-baseline assessment of the efficacy parameter. Twenty participants had no efficacy variables collected.||Scores on a scale||Standard Deviation|Mean
648716|NCT02097056|Secondary|Change From Baseline in the Mini-Mental State Examination (MMSE) Score|The MMSE was used to measure cognitive impairment. The MMSE can evaluate overall cognitive function, and is widely used for the assessment of cognitive impairment in dementia patients. The questionnaire consists of 11 items, and each item aims to evaluate different cognitive domains such as orientation, memory, attention, and construction. The score ranged from 0 to 30, with a higher score indicating better function. A positive change score indicated improvement from baseline. The mean change was analyzed by Wilcoxon’s signed rank test.|Baseline, Week 12, and Week 24 (Final visit)|Efficacy analysis population included all participants who took at least one dose of study drug and had at least one baseline and at least one post-baseline assessment of the efficacy parameter. Twenty participants had no efficacy variables collected.||Scores on a scale||Standard Deviation|Mean
648717|NCT02097056|Primary|Overall Summary of Adverse Events (AEs)|Safety of study drug was assessed by clinical laboratory assessments, vital signs, weight, 12-lead electrocardiogram (ECG), physical and neurological examination. Treatment-Emergent Adverse Events (TEAEs) were defined as any event not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Serious adverse events were defined as AEs that led to or were life-threatening, resulted in or prolonged hospitalization, caused important or long-lasting disability, caused congenital abnormality or malformation, or resulted in death. Adverse drug reactions were defined as any harmful or unintended reaction to study treatment and were considered possibly related or probably related to study drug. Specific AEs and SAEs due to changes in clinical laboratory assessments, vital signs, weight, ECG, and physical and neurological exam are listed in the safety section.|Baseline (Day 1) up to Week 24|Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment.||Percentage of participants|||Number
648718|NCT02097030|Secondary|Ocular Health - Biomicroscopy|The investigator’s objective assessment of ocular health assessed for each study Pair after 3 days wear by biomicroscopy. Bulbar and Limbal Hyperemia; Corneal Staining Type, Extent and Depth, Conjunctival Staining and Indentation. BrienHolden Vision Institute Continuous Scale: 1-4, 0.5 steps (1=Very, 2=Slight, 3=Moderate, 4=Severe)|3 Days Follow-up|Only right eye data shown. Left eye data virtually identical. One subject had non-contact lens related adverse event in the nelfilcon A group. Subject temporarily discontinued and went on to complete the study.||units on a scale||Standard Deviation|Mean
648719|NCT02097030|Secondary|Lens Fit and Performance - Tightness (Baseline and 3 Day Follow-up)|The investigator's objective assessment for contact lens fit and performance - tightness. Measured at baseline (10-15mins settling) for both study pairs. Tightness (Scale 0-4, 0.25 steps, 0=Should not be worn, 4=Perfect).|Baseline and 3 day follow-up|||units on a scale||Standard Deviation|Mean
648720|NCT02097030|Secondary|Lens Fit and Performance - Fit Acceptance|The investigator's objective assessment for contact lens fit and performance - fit acceptance. Measured at baseline and 3 day follow-up (10-15mins settling) for both study pairs. Fit acceptance (Scale 0-4, 0.25 steps, 0=Should not be worn, 4=Perfect).|Baseline and 3 day follow-up|||units on a scale||Standard Deviation|Mean
648721|NCT02097030|Secondary|Lens Fit and Performance - Movement (Baseline and 3 Days Follow-up)|The investigator's objective assessment for contact lens fit and performance - movement. Measured at baseline (10-15mins settling) for both study pairs. Movement (scale in millimeters).|Baseline and 3 days follow-up|||units on a scale||Standard Deviation|Mean
648722|NCT02097030|Secondary|Lens Fit and Performance - Debris (Baseline and 3 Day Follow-up)|The investigator's objective assessment for contact lens fit and performance - debris. Measured at baseline (10-15mins settling) for both study pairs. (Debris scale 0-4; 0.25 steps; 0=no debris, 4=significant debris)|Baseline and 3 day follow-up|||units on a scale||Standard Deviation|Mean
648723|NCT02097030|Secondary|Lens Fit and Performance - Deposits (Baseline and 3 Days Follow-up)|The investigator's objective assessment for contact lens fit and performance - deposits. Measured at baseline (10-15mins settling) for both study pairs. Deposits (scale 0-4, 0.25 steps, 0=excellent, 4 severely reduced);|Baseline and 3 days follow-up|||units on a scale||Standard Deviation|Mean
648724|NCT02097030|Secondary|Lens Fit and Performance - Wettability (Baseline and 3 Days Follow-up)|The investigator's objective assessment for contact lens fit and performance - wettability. Measured at baseline (10-15mins settling) for both study pairs. Wettability (scale 0-4, 0.25 steps, 0=excellent, 4 severely reduced).|Baseline and 3 days follow-up|||units on a scale||Standard Deviation|Mean
648725|NCT02097030|Secondary|Overall Satisfaction|Participant’s subjective response for overall satisfaction. Measured after 3 days of daily disposable lens wear. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied.|3 Days Follow-up|Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.||participants|||Number
648726|NCT02097030|Secondary|Overall Satisfaction, Dryness|Participant’s subjective response for overall dryness satisfaction. Measured after 3 days daily disposable wear of lenses. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied.|3 Days Follow-up|Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.||participants|||Number
648729|NCT02097030|Secondary|Overall Satisfaction, Vision|Participant’s subjective response for overall vision satisfaction. Measured after 3 days daily disposable wear of lenses. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied.|3 Days Follow-up|Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.||participants|||Number
648730|NCT02097030|Secondary|Subjective Response for Dryness|Participant’s subjective response for dryness, measured at baseline and after 3 day follow-up of daily disposable wear of lenses. (Dryness Scale 0-100, 0=Cannot be worn/extremely dry, 100=no dryness experienced at any time).|3 Days Follow-up|Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.||units on a scale||Standard Deviation|Mean
648731|NCT02097030|Secondary|Subjective Response for Handling (Insertion and Removal)|Participant’s subjective response for handling (insertion and removal) measured at 3 day follow-up of daily disposable wear of lenses. (Handling Scale 0-100, 0=very hard to handle, 100=very easy to handle).|3 days follow-up|Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.||units on a scale||Standard Deviation|Mean
648732|NCT02097030|Secondary|Subjective Response for Insertion|Participant’s subjective response for insertion measured at baseline. (Insertion Handling Scale 0-100, 0=very hard to handle, 100=very easy to handle).|Baseline|Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.||units on a scale||Standard Deviation|Mean
648733|NCT02097030|Secondary|Subjective Response for Vision|Participant’s subjective response for vision measured at baseline and at 3 day follow-up of daily disposable wear of lenses. (Vision Scale 0-100, 0=very blurry, 100=very clear).|Baseline and 3 day follow-up|Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.||units on a scale||Standard Deviation|Mean
648734|NCT02097030|Secondary|Subjective Response for Comfort|Participant’s subjective response for comfort measured at baseline and 3 day follow-up. (Continuous Comfort Scale 0-100, 0=cannot be worn/causes pain, 100=cannot be felt ever)|Baseline and 3 day follow-up|Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.||units on a scale||Standard Deviation|Mean
648735|NCT02097030|Primary|Overall Lens Preference - Hydrogel vs. Filcon II 3|Participant’s subjective response for overall lens preference after 3 days of daily disposable wear of each pair. Surveyed at exit. (4 possible ratings: Strongly prefer pair#1, Slightly prefer pair #1, Slightly prefer pair #2, Strongly prefer pair #2).|Study Exit|30 subjects||participants|||Number
648736|NCT02097030|Primary|Overall Lens Preference - All Study Lenses|Participant’s subjective response for overall lens preference after 3 days of daily disposable wear of each pair of lenses. Surveyed at exit. (4 possible ratings: Strongly prefer pair#1, Slightly prefer pair #1, Slightly prefer pair #2, Strongly prefer pair #2).|Study Exit|Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.||participants|||Number
648737|NCT02096900|Post-Hoc|Modified Yale Preoperative Anxiety Scale (mYPAS) Score at Separation (mYPAS2) Based on Baseline (mYPAS1) Score.|"Midazolam group participants will be separated into two groups; non-anxious (mYPAS1 ≤ 30) at baseline and anxious (mYPAS1 > 30) at baseline. The mYAPS2 scores of these two groups will be compared to the mYPAS2 scores of the Zolpidem group participants.
The modified Yale Preoperative Anxiety scale (m-YPAS) is a structured observational measure of preoperative anxiety in children that takes less than a minute to preform. It consists of assessment of 27 items in 5 domains of behavior indicating anxiety in young children; activity, emotional expressivity, state of arousal, vocalization, and use of parents. Each item is weighted in calculation of the total score that ranges from 22.5 -100. A cut off 30 on the m-YPAS scale was found to balance the high specificity and sensitivity while maintaining high positive predictive value. Children with a score above 30 are considered anxious while those with the score of 30 or less were considered not anxious."|Up to 24 hours including pre-operative, peri-operative and post-operative periods.|||units on a scale||Inter-Quartile Range|Median
648738|NCT02096900|Secondary|Parental/Caregiver Anxiety Assessed Using the Validated State-Trait Anxiety Inventory for Adults (STAI)|"Parental/caregiver anxiety, was assessed using the validated State-Trait Anxiety Inventory for Adults (STAI), a validated self-evaluation questionnaire.
The STAI is compromised of separate self-report scales for measuring state and trait anxiety. The S-Anxiety scale (STAI Form Y-1) consists of twenty statements that evaluate how respondents feel “right now, at this moment”. The T-Anxiety scale (STAI Form Y-2) consists of twenty statements that assess how respondents generally feel. The score ranges from 20 (most relaxed) to 80 (highest stress).
The baseline STAI inventory was completed by e parent/caregiver after obtaining the informed consent in the preoperative holding area and before the subject was separated from the caregiver. Baseline STAI inventory consisted of form STAIY-1 (State Anxiety) and form STAIY-2 (Trait Anxiety) anxiety.
After caregiver/patient separation,form STAIY-1(State Anxiety) was completed again by the caregiver."|Preoperative holding area from the time of informed consent until caregiver/patient separation.|only total of 51 subjects were analyzed. Caregivers of 29 subjects were given incorrect form to fill at time of separation rendering data not applicable for analysis for the 29 subjects.||units on a scale||Standard Deviation|Mean
648739|NCT02096900|Secondary|Presence of Emergence Delirium During Recovery|Presence or absence of emergence delirium during recovery, will be assessed using the pediatric anesthesia emergence delirium (PAED) scale recorded at 5-minute intervals for 20 minutes following the child's spontaneous eye opening. PAED score of ≥12 at any time indicates presence of emergence delirium.|Up to 30 minutes after child's first eye opening in the post-operative period.|||Participants|||Count of Participants
648740|NCT02096900|Secondary|Mask Acceptance Score|"Mask acceptance by the patient, will be measured on a 4-point scale adapted from a similar trial.
Score of 1 and 2 indicates satisfactory mask acceptance. Score of 3 or 4 indicates unsatisfactory mask acceptance during induction of general anesthesia."|During induction of general anesthesia.|||Participants|||Count of Participants
648939|NCT02093923|Secondary|Apparent Volume of Distribution (Vd/F)||Pharmacokinetic samples were drawn on Days 1, 2, 4, 8, 15, 16, 18, 22, 29, 36, 50, 64, 92, and 120.|All randomized HAE subjects who received at least 1 dose of DX-2930 and who have sufficient blood samples for pharmacokinetic analyses. Results from placebo-treated subjects were not analyzed for summary statistics since these subjects did not have detectable drug levels.||liters||Standard Deviation|Mean
648741|NCT02096900|Primary|Patient Anxiety at the Time of Separation|"The primary outcome measure of patient anxiety will be measured using the validated Modified Yale Preoperative Anxiety Score (mYPAS). The mYPAS is the current standard for evaluation of anxiety in children receiving anesthesia for surgical procedures.
The modified Yale Preoperative Anxiety scale (m-YPAS) is a structured observational measure of preoperative anxiety in children. It was developed by the study group lead by Kain Z. It consists of assessment of 27 items in 5 domains of behavior indicating anxiety in young children; activity, emotional expressivity, state of arousal, vocalization, and use of parents. Each item is weighted in calculation of the total score that ranges from 22.5 -100. Children with a score above 30 are considered anxious while those with the score of 30 or less were considered not anxious."|Up to 24 hours including preoperative, preoperative, and postoperative periods.|||units on a scale||Inter-Quartile Range|Median
648742|NCT02096835|Other Pre-specified|Need of Postoperative Metoclopramide|the number of patients who needed metoclopramide as a rescue medicine postoperatively|within 48h after operation|||participants|||Number
648743|NCT02096835|Secondary|Number of Participants Experiencing Postoperative Vomiting in 24h Postoperatively|including retching and vomiting|within 24h after operation|||participants|||Number
648744|NCT02096835|Secondary|Number of Participants Experiencing Postoperative Nausea in 24h Postoperatively||within 24h after the operation|||participants|||Number
648745|NCT02096835|Primary|Number of Participants Experiencing Postoperative Nausea and Vomiting in 24h Postoperatively|the total number including nausea, retching and vomiting within 24h after operation|within 24h after operation|||participants|||Number
648746|NCT02096744|Secondary|Cmax (Maximum Concentration of Clonidine in Plasma)|Cmax (maximum concentration of clonidine in plasma) The values for geometric mean and gCV are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.|1 hour (h) before patch administration and 12h, 24h, 48h, 72h, 96h, 120h, 144h, 168h, 192h, 216h, 240h after patch administration|PKS included all treated subjects who provided at least one observation for at least one primary endpoint without protocol violations with respect to the statistical evaluation of PK endpoints.||pg/mL||Geometric Coefficient of Variation|Geometric Mean
648747|NCT02096744|Secondary|AUC0-inf(Area Under the Concentration-time Curve of Clonidine in Plasma Over the Time Interval From 0 to Infinity)|AUC 0-inf(area under the concentration-time curve of clonidine in plasma over the time interval from 0 to infinity) The values for geometric mean and gCV are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.|1 hour (h) before patch administration and 12h, 24h, 48h, 72h, 96h, 120h, 144h, 168h, 192h, 216h, 240h after patch administration|PKS included all treated subjects who provided at least one observation for at least one primary endpoint without protocol violations with respect to the statistical evaluation of PK endpoints.||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
648748|NCT02096744|Primary|Cavg (Average of Measured Concentrations of Clonidine in Plasma on Days 5, 6, and 7)|Cavg (average of measured concentrations of clonidine in plasma on Days 5, 6, and 7) The values for geometric mean and gCV are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.|1 hour (h) before patch administration and 12h, 24h, 48h, 72h, 96h, 120h, 144h, 168h, 192h, 216h, 240h after patch administration|PKS included all treated subjects who provided at least one observation for at least one primary endpoint without protocol violations with respect to the statistical evaluation of PK endpoints.||pg/mL||Geometric Coefficient of Variation|Geometric Mean
648749|NCT02096744|Primary|AUC0-168 (Area Under the Concentration-time Curve of Clonidine in Plasma Over the Time Interval From 0 to 168 h)|AUC0-168 (area under the concentration-time curve of clonidine in plasma over the time interval from 0 to 168 h) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.|1 hour (h) before patch administration and 12h, 24h, 48h, 72h, 96h, 120h, 144h, 168h after patch administration|PKS included all treated subjects who provided at least one observation for at least one primary endpoint without protocol violations with respect to the statistical evaluation of PK endpoints.||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
648750|NCT02096731|Primary|Community Acquired Pneumonia|"The community acquired pneumonia rate per 1000 patients per year after matching on high-dimensional propensity score and inhaled corticosteroid (ICS) use in the year prior to cohort entry.
Pt. = Patient"|Up to 12 months|The subset of patients from the base cohort who were either on monotherapy (who stayed on monotherapy) or combination therapy (who added tiotropium to LABA or added LABA to tiotropium), who can be linked to the Hospital Episode Statistics database, and were matched via propensity score.||No.of incident Pneumonia/1000 pt./year|||Number
648751|NCT02096731|Primary|Cardiac Arrhythmia|The cardiac arrhythmia (CA) rate per 1000 patients per year after matching on high-dimensional propensity score and inhaled corticosteroid (ICS) use in the year prior to cohort entry.|Up to 12 months|The subset of patients from the base cohort who were either on monotherapy (who stayed on monotherapy) or combination therapy (who added tiotropium to LABA or added LABA to tiotropium), who can be linked to the Hospital Episode Statistics database, and were matched via propensity score.||No. of incident CA/1000patients /year|||Number
648752|NCT02096731|Primary|Heart Failure|The heart failure (HF) rate per 1000 patients per year after matching on high-dimensional propensity score and inhaled corticosteroid (ICS) use in the year prior to cohort entry.|Up to 12 months|The subset of patients from the base cohort who were either on monotherapy (who stayed on monotherapy) or combination therapy (who added tiotropium to LABA or added LABA to tiotropium) and were matched via propensity score.||No. of incident HF/1000patients/year|||Number
648753|NCT02096731|Primary|Stroke|The stroke rate per 1000 patients per year after matching on high-dimensional propensity score and inhaled corticosteroid (ICS) use in the year prior to cohort entry.|Up to 12 months|The subset of patients from the base cohort who were either on monotherapy (who stayed on monotherapy) or combination therapy (who added tiotropium to LABA or added LABA to tiotropium) and were matched via propensity score.||No. of incident stroke/1000patients/year|||Number
648754|NCT02096731|Primary|Myocardial Infarction|"The acute myocardial infarction (MI) rate per 1000 patients per year after matching on high-dimensional propensity score and inhaled corticosteroid (ICS) use in the year prior to cohort entry.
No. = Number"|Up to 12 months|The subset of patients from the base cohort who were either on monotherapy (who stayed on monotherapy) or combination therapy (who added tiotropium to LABA or added LABA to tiotropium) and were matched via propensity score.||No. of incident MI/1000patients/ year|||Number
648755|NCT02096718|Secondary|AUC 0-inf of Afatinib (BIBW 2992)|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity|PK plasma samples were taken at: 1 hour before drug administration and 0.5 hour (h), 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 312h after first drug administration|The pharmacokinetic set (PKS): included all patients in the treated set who provided evaluable data for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
648756|NCT02096718|Primary|Cmax of Afatinib (BIBW 2992)|Maximum measured concentration of the analyte in plasma|PK plasma samples were taken at: 1 hour before drug administration and 0.5 hour (h), 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 312h after first drug administration|The pharmacokinetic set (PKS): included all patients in the treated set who provided evaluable data for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
648757|NCT02096718|Primary|AUC 0-tz of Afatinib (BIBW 2992)|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 up to the last quantifiable data point|PK plasma samples were taken at: 1 hour before drug administration and 0.5 hour (h), 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 312h after first drug administration|The pharmacokinetic set (PKS): included all patients in the treated set who provided evaluable data for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
648758|NCT02096705|Secondary|Adjusted Mean Change in Absolute Calculated Mean Total Daily Dose of Insulin (TDDI) From Baseline to Week 24|The adjusted mean change in absolute calculated mean Total Daily Dose of Insulin (TDDI) from baseline to week 24 was reported for each arm in International Units (IU).|Baseline (Day 1) and 24 weeks|All randomized participants with non-missing baseline and at least one post-baseline value||International Units (IU)||Standard Error|Mean
648759|NCT02096705|Secondary|Adjusted Mean Change in Body Weight From Baseline to Week 24|Adjusted mean change in body weight from baseline to week 24 was reported for each arm in kilograms (kg).|Baseline (Day 1) and 24 weeks|All randomized participants with non-missing baseline and at least one post-baseline value||kilograms||Standard Error|Mean
648760|NCT02096705|Secondary|Adjusted Mean Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24|The adjusted mean change from baseline to 24 weeks in Fasting Plasma Glucose (FPG) was reported for each arm in milligrams per deciliter (mg/dL).|Baseline (Day 1) and 24 weeks|All randomized participants with non-missing baseline and at least one post-baseline value||mg/dL||Standard Error|Mean
648761|NCT02096705|Primary|Adjusted Mean Change in HbA1c From Baseline to Week 24|The adjusted mean change in the percentage of Hemoglobin A1c (HbA1c) from baseline to Week 24 was reported for each arm.|Baseline (Day 1) and 24 weeks|All randomized participants with non-missing baseline and at least one post-baseline value||percentage of hemoglobin||Standard Error|Mean
648762|NCT02096692|Primary|Percentage of Participants Free of R-wave Sensing Attenuation|Evaluate the percentage of subjects free of R-wave attenuation between the Pre-MRI and one-month post-MRI follow-up.|Between Pre-MRI and 1 Month Post-MRI|All participants who had measurable R-waves at both pre-MRI and and 1 Month Post-MRI.||percentage of participants||95% Confidence Interval|Number
648763|NCT02096692|Primary|Percentage of Participants Free of Ventricular Pacing Threshold Rise|Evaluate the percentage of ICD leads free of ventricular pacing threshold increase between the Pre-MRI and one-month post-MRI follow-up.|Between Pre-MRI and 1 Month Post-MRI|||percentage of participants||95% Confidence Interval|Number
648764|NCT02096692|Primary|MRI and ICD System Related Serious Adverse Device Effect (SADE) Free Rate||1 Month Post-MRI|||percentage of participants||95% Confidence Interval|Number
648765|NCT02096679|Secondary|Pharmacokinetics of AZD9291 and Urine [14C] Total Radioactivity by Assessment of Percentage (or Fraction) of Actually Administered Dose / Radioactivity (Feu)|Pharmacokinetics of AZD9291 and urine [14C] total radioactivity by assessment of percentage (or fraction) of actually administered dose / radioactivity (feu), derived from the curve taken during the treatment period.|Urine (h): 0-4, 4-8, 8-12, 12-24, every 24 hrs to 504, 648-72, 816-40, 984-1008 and 1992-2016.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product||Percentage of administered dose||Standard Deviation|Mean
648766|NCT02096679|Secondary|Pharmacokinetics of AZD9291, Its Metabolites and Urine [14C] Total Radioactivity by Assessment of Urine Concentration or Concentration Equivalent x Urine Volume (Aeu)|Pharmacokinetics of AZD9291, its metabolites and urine [14C] total radioactivity by assessment of urine concentration or concentration equivalent x urine volume (Aeu), derived from the curve taken during the treatment period.|Urine (h): 0-4, 4-8, 8-12, 12-24, every 24 hrs to 504, 648-72, 816-40, 984-1008 and 1992-2016.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product||nmol||Standard Deviation|Mean
648767|NCT02096679|Secondary|Pharmacokinetics of AZD9291, Its Metabolites and Whole Blood and Plasma [14C] Radioactivity by Assessment of Area Under the Concentration-time Curve AUC|Pharmacokinetics of AZD9291, its metabolites and whole blood and plasma [14C] radioactivity by assessment of area under the concentration-time curve AUC, derived from the curve taken during the treatment period.|Blood samples (hrs) – 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, every 24 to 168, 336, 504, 648, 816, 904 and 1992.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product||nM*h||Full Range|Geometric Mean
648777|NCT02096679|Secondary|Pharmacokinetics of AZD9291 Plasma, Whole Blood and Plasma [14C] Radioactivity by Assessment of Apparent Oral Clearance (CL/F)|Pharmacokinetics of AZD9291 plasma, whole blood and plasma [14C] radioactivity by assessment of apparent oral clearance (CL/F), derived from the curve taken during the treatment period.|Blood samples (hrs) – 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, every 24 to 168, 336, 504, 648, 816, 904 and 1992.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product||L/h||Full Range|Mean
648768|NCT02096679|Secondary|Pharmacokinetics of AZD9291, Its Metabolites and Whole Blood and Plasma [14C] Radioactivity by Assessment of AUC Ratio of WBR to PR (AUC(WBR)/AUC(PR))|Pharmacokinetics of AZD9291, its metabolites and whole blood and plasma [14C] radioactivity by assessment of AUC ratio of WBR to PR (AUC(WBR)/AUC(PR)), derived from the curves taken during the treatment period.|Blood samples (hrs) – 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, every 24 to 168, 336, 504, 648, 816, 904 and 1992.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product||ratio||Full Range|Geometric Mean
648769|NCT02096679|Secondary|Pharmacokinetics of AZD9291, Its Metabolites and Whole Blood and Plasma [14C] Radioactivity by Assessment of AUC Ratio of Plasma AZD9291, AZD7550 or AZD5104 (PL) to Plasma Radioactivity (PR) AUC(PL)/AUC(PR)|Pharmacokinetics of AZD9291, its metabolites and whole blood and plasma [14C] radioactivity by assessment of AUC ratio of plasma AZD9291, AZD7550 or AZD5104 (PL) to plasma radioactivity (PR) AUC(PL)/AUC(PR), derived from the curves taken during the treatment period.|Blood samples (hrs) – 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, every 24 to 168, 336, 504, 648, 816, 904 and 1992.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product||ratio||Full Range|Geometric Mean
648770|NCT02096679|Secondary|Pharmacokinetics of AZD9291, Its Metabolites and Whole Blood and Plasma [14C] Radioactivity by Assessment of Cmax Ratio of Whole Blood Radioactivity (WBR) to PR Cmax (WBR)/Cmax(PR)|Pharmacokinetics of AZD9291, its metabolites and whole blood and plasma [14C] radioactivity by assessment of Cmax ratio of whole blood radioactivity (WBR) to PR Cmax (WBR)/Cmax(PR), derived from the curves taken during the treatment period.|Blood samples (hrs) – 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, every 24 to 168, 336, 504, 648, 816, 904 and 1992.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product||ratio||Full Range|Geometric Mean
648771|NCT02096679|Secondary|Pharmacokinetics of AZD9291, Its Metabolites and Whole Blood and Plasma [14C] Radioactivity by Assessment of Cmax Ratio of Plasma AZD9291, AZ7550 or AZ5104 (PL) to Plasma Radioactivity (Cmax(PL)/Cmax(PR))|Pharmacokinetics of AZD9291, its metabolites and whole blood and plasma [14C] radioactivity by assessment of Cmax ratio of plasma AZD9291, AZ7550 or AZ5104 (PL) to plasma radioactivity (Cmax(PL)/Cmax(PR)), derived from the curves taken during the treatment period.|Blood samples (hrs) – 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, every 24 to 168, 336, 504, 648, 816, 904 and 1992.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product||ratio||Full Range|Geometric Mean
648772|NCT02096679|Secondary|Pharmacokinetics of AZD9291, Its Metabolites and Whole Blood and Plasma [14C] Radioactivity by Assessment of Cmax Metabolite to Parent Ratio, AZ7550 or AZ5104 (M/PCmax)|Pharmacokinetics of AZD9291, its metabolites and whole blood and plasma [14C] radioactivity by assessment of Cmax metabolite to parent ratio, AZ7550 or AZ5104 (M/PCmax), derived from the curves taken during the treatment period.|Blood samples (hrs) – 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, every 24 to 168, 336, 504, 648, 816, 904 and 1992.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product||ratio||Full Range|Geometric Mean
648773|NCT02096679|Secondary|Pharmacokinetics of AZD9291, Its Metabolites and Whole Blood and Plasma [14C] Radioactivity by Assessment of AUC Metabolite to Parent Ratio, AZ7550 or AZ5104 AUC/AZD9291 AUC Adjusted for Differences in Molecular Weight (M/PAUC)|Pharmacokinetics of AZD9291, its metabolites and whole blood and plasma [14C] radioactivity by assessment of AUC metabolite to parent ratio, AZ7550 or AZ5104 AUC/AZD9291 AUC adjusted for differences in molecular weight (M/PAUC), derived from the curves taken during the treatment period.|Blood samples (hrs) – 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, every 24 to 168, 336, 504, 648, 816, 904 and 1992.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product||Ratio||Full Range|Geometric Mean
648774|NCT02096679|Secondary|Pharmacokinetics of AZD9291, Its Metabolites and Whole Blood and Plasma [14C] Radioactivity by Assessment of Elimination Rate Constant (λz)|Pharmacokinetics of AZD9291, its metabolites and whole blood and plasma [14C] radioactivity by assessment of elimination rate constant (λz), derived from the curve taken during the treatment period.|Blood samples (hrs) – 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, every 24 to 168, 336, 504, 648, 816, 904 and 1992.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product||1/h||Full Range|Geometric Mean
648775|NCT02096679|Secondary|Pharmacokinetics of AZD9291, Its Metabolites and Whole Blood and Plasma [14C] Radioactivity by Assessment of Elimination Half-life (t1/2,λz)|Pharmacokinetics of AZD9291, its metabolites and whole blood and plasma [14C] radioactivity by assessment of elimination half-life (t1/2,λz), derived from the curve taken during the treatment period.|Blood samples (hrs) – 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, every 24 to 168, 336, 504, 648, 816, 904 and 1992.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product||hour||Full Range|Mean
648776|NCT02096679|Secondary|Pharmacokinetics of AZD9291 Plasma, Whole Blood and Plasma [14C] Radioactivity by Assessment of Apparent Volume of Distribution (Vz/F)|Pharmacokinetics of AZD9291, its metabolites and whole blood and plasma [14C] radioactivity by assessment of apparent volume of distribution (Vz/F), derived from the curve taken during the treatment period.|Blood samples (hrs) – 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, every 24 to 168, 336, 504, 648, 816, 904 and 1992.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product||L||Full Range|Mean
657594|NCT01919229|Secondary|Change From Baseline in Expression of Cyclin-Dependent Kinase 1 (CDK1)||Baseline, Day 15|Since the study was terminated, no efficacy data was obtained.|||||
648778|NCT02096679|Secondary|Pharmacokinetics of AZD9291, Its Metabolites and Whole Blood and Plasma [14C] Radioactivity by Assessment of Lag Time Before Observation of Quantifiable Analyte Concentrations (Tlag)|Pharmacokinetics of AZD9291, its metabolites and whole blood and plasma [14C] radioactivity by assessment of lag time before observation of quantifiable analyte concentrations (tlag), derived from the curve taken during the treatment period.|Blood samples (hrs) – 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, every 24 to 168, 336, 504, 648, 816, 904 and 1992.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product||hours||Inter-Quartile Range|Median
648779|NCT02096679|Secondary|Pharmacokinetics of AZD9291, Its Metabolites and Whole Blood and Plasma [14C] Radioactivity by Assessment of Time to Cmax (Tmax)|Pharmacokinetics of AZD9291, its metabolites and whole blood and plasma [14C] radioactivity by assessment of by assessment of time to Cmax (tmax), derived from the curve taken during the treatment period.|Blood samples (hrs) – 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, every 24 to 168, 336, 504, 648, 816, 904 and 1992.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product||hours||Inter-Quartile Range|Median
648780|NCT02096679|Secondary|Pharmacokinetics of AZD9291, Its Metabolites and Whole Blood and Plasma [14C] Radioactivity by Assessment of Maximum Plasma Concentration (Cmax)|Pharmacokinetics of AZD9291, its metabolites and whole blood and plasma [14C] radioactivity by assessment of maximum plasma concentration (Cmax), derived from the curve taken during the treatment period.|Blood samples (hrs) – 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, every 24 to 168, 336, 504, 648, 816, 904 and 1992.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product||nM||Full Range|Geometric Mean
648781|NCT02096679|Secondary|Pharmacokinetics of AZD9291, Its Metabolites and Whole Blood and Plasma [14C] Radioactivity by Assessment of Area Under the Concentration-time Curve From Time Zero to 24 Hours AUC(0-24)|Pharmacokinetics of AZD9291, its metabolites and whole blood and plasma [14C] radioactivity by assessment of area under the concentration-time curve from time zero to the time of 24 hours AUC(0-24), derived from the curve taken during the treatment period.|Blood samples (hrs) – 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product||nM*h||Full Range|Geometric Mean
648782|NCT02096679|Secondary|Pharmacokinetics of AZD9291, Its Metabolites and Whole Blood and Plasma [14C] Radioactivity by Assessment of Area Under the Concentration-time Curve From Time Zero to the Time of 72 Hours AUC(0-72)|Pharmacokinetics of AZD9291, its metabolites and whole blood and plasma [14C] radioactivity by assessment of area under the concentration-time curve from time zero to the time of 72 hours AUC(0-72), derived from the curve taken during the treatment period.|Blood samples (hrs) – 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product||nM*h||Full Range|Geometric Mean
648783|NCT02096679|Secondary|Pharmacokinetics of AZD9291, Its Metabolites and Whole Blood and Plasma [14C] Radioactivity by Assessment of Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration AUC(0-t)|Pharmacokinetics of AZD9291, its metabolites and whole blood and plasma [14C] radioactivity by assessment of area under the concentration-time curve from time zero to the time of the last quantifiable concentration AUC(0-t), derived from the curve taken during the treatment period.|Blood samples (hrs) – 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, every 24 to 168, 336, 504, 648, 816, 904 and 1992.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product||nM*h||Full Range|Geometric Mean
648784|NCT02096679|Primary|Percentage of Radioactive Dose of [14C] Radiolabelled AZD9291 Recovered in Urine, Faeces, and in Total.|The percentage of radioactive dose of [14C] radiolabelled AZD9291 recovered in urine, faeces, and in total, up to Day 85.|Blood samples (hrs) – 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, every 24 to 168, 336, 504, 648, 816, 904 and 1992. Urine (h): 0-4, 4-8, 8-12, 12-24, every 24 hrs to 504, 648-72, 816-40, 984-1008 and 1992-2016. Faeces: 0-24h and then as per urine.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product||Percentage radioactive dose recovered||Standard Deviation|Mean
648785|NCT02096575|Secondary|Visual Analog Scale to Measure Anticipated Pain.|Anticipated pain is assessed before the procedure. Pain was assessed using the Visual Analog Scale (VAS). 0 = no pain, 100 = maximum pain|Anticipated pain assessed on average within 30 minutes before procedure|||units on a scale||Standard Deviation|Mean
648786|NCT02096575|Secondary|Pain Management Satisfaction|Quantitative assessment of pain management. Pain was assessed using the Visual Analog Scale (VAS). 0 = no pain, 100 = maximum pain|Visual analog scale for satisfaction administered on average within 20 minutes after procedure completion.|||units on a scale||Standard Deviation|Mean
648787|NCT02096575|Secondary|Visual Analog Scale for Post-procedure Pain|A quantitative assessment of post-procedure pain. Pain was assessed using the Visual Analog Scale (VAS). 0 = no pain, 100 = maximum pain|Visual analog scale administered on average 20 minutes after procedure completed|||units on a scale||Standard Deviation|Mean
648788|NCT02096575|Secondary|Visual Analog Scale Score for Baseline Pain|A quantitative assessment of pain prior to the procedure. Pain was assessed using the Visual Analog Scale (VAS). 0 = no pain, 100 = maximum pain|Baseline pain assessment on average within 30 minutes before procedure|||units on a scale||Standard Deviation|Mean
648789|NCT02096575|Primary|Visual Analog Pain Score for Mean Maximum Procedural Pain|"The primary outcome of this study is to evaluate the difference in mean maximum pain experienced during the procedure between groups as assessed 5 minutes after the procedure is completed.
Pain was assessed using the Visual Analog Scale (VAS). 0 = no pain, 100 = maximum pain"|Mean maximum pain experienced during the procedure and assessed 5 minutes after the procedure|||units on a scale||Full Range|Mean
648790|NCT02096458|Primary|Time to In-Vivo Disintegration of Dexlansoprazole 30 mg Orally Disintegrating Tablets|The disintegration time is the total time from when the participant places the tablet on their tongue until the time at which the participant would normally swallow the remaining materials from the disintegrated tablet. The average disintegration time will be calculated for each participant based on 3 separate tests.|Day 1|The populations consisted of all enrolled participants.||Seconds||Full Range|Mean
649104|NCT02091752|Secondary|Proportion of Patients Achieving ≥25% and ≥50% Reduction, Respectively, From Baseline in Total Symptom Score (MPN-SAF TSS)||Week 24|The study was terminated early due to low enrollment. Analysis was not done.|||||
648805|NCT02096042|Primary|Overall Response Rate|Response defined as number of participants with complete response (CR), CR with incomplete platelet recovery (CRp), CR with insufficient hematological recovery (CRi) or partial remission (PR).|Response assessed after four 28-day cycles, up to 120 days|Study was stopped with only one participant; no analysis done on outcome.|||||
648806|NCT02096042|Primary|Maximum Tolerated Dose (MTD) of Brentuximab Vedotin in Combination With 5-Azacytidine|MTD defined as maximum dose at which <33% of patients experience a dose-limiting toxicity (DLT) during cycle 1.|After 1, 28 day cycle|Study terminated early.|||||
648807|NCT02095873|Other Pre-specified|Aortal Pulse Wave Velocity (aPWV)|Aortal pulse wave velocity is measured by a non-invasive oscillometric device.|Week 0 and Week 8 (first intervention); Week 14 and Week 22 (second intervention)|Subjects for which PWV data were obtained at baseline and post 8-weeks treatment.||m/s||Inter-Quartile Range|Median
648808|NCT02095873|Secondary|Flow-mediated Dilatation (FMD)|Brachial artery FMD will be assessed. Ultrasound imaging of the brachial artery will be performed. Percent FMD will be calculated using the averaged minimum mean brachial artery diameter at baseline compared to the largest mean values obtained after either release of the forearm occlusion.|Week 0 and Week 8 (first intervention); Week 14 and Week 22 (second intervention)|All subjects completing the study per protocol||percentage of baseline value||Inter-Quartile Range|Median
648809|NCT02095873|Secondary|Finger-fold Capillary Density by Capillaroscopy|After 20 min seated at rest, measurements are made with the subject seated and the left hand at heart level. Nail-fold capillaries in the dorsal skin of the third finger are visualized using a stereo microscope linked to a monochrome digital camera. Capillary density is defined as the number of capillaries per mm2 of nail-fold skin and is computed as the mean of 4 measurements.|Week 0 and Week 8 (first intervention); Week 14 and Week 22 (second intervention)|All subjects with where baseline and post-8 treatment data were obtained.||number of capillaries per mm2||Inter-Quartile Range|Median
648810|NCT02095873|Primary|Area Under the Curve for Oral Glucose Tolerance Test (oGGT)|A standard 75 g glucose oGTT will be performed, as routinely used in clinical practice. Participants will be instructed to eat carbohydrate rich diet (> 150 g/day) for at least three days before the test, followed by an overnight fast. Participants will be instructed to have comparable macronutrient composition of the dinner before the respective study days in the metabolic unit. During the oGTT both capillary and venous blood samples will be collected after 0, 15, 30, 60, 90 and 120 min. To minimize the inconvenience of repeated blood tests during the oGTT, a venous cannula will be inserted, under sterile conditions, prior to the test, for blood sampling.|Week 0 and Week 8 (first intervention); Week 14 and Week 22 (second intervention)|Highly overweight/obese (BMI>27.5 kg/m2) subgroup, based on subject BMI at study entry.||mM h||Standard Error|Mean
648811|NCT02095691|Secondary|Incidence of Subjects Achieving a ≥ 10 mmHg Reduction in Systolic Blood Pressure (SBP) at 1, 3, 6 and 12 Months Post Procedure|Incidence of subjects achieving a 10 mmHg or more reduction in Systolic Blood Pressure (SBP) at 1, 3, 6 and 12 months post procedure.|12 months post-procedure|Effectiveness analysis population, which consists of enrolled subjects without enrollment deviation and experiencing technical success. Technical success is defined as the investigational catheter being successfully inserted into the femoral artery with radiofrequency energy successfully applied in at least one artery.||percentage of participants|||Number
648812|NCT02095691|Secondary|Incidence of Subjects Achieving Target Systolic Blood Pressure (SBP) at 1, 3, 6 and 12 Months Post Procedure|The pre-specified target SBP is defined as SBP <130 mmHg. This endpoint is defined at each of 1, 3, 6 and 12 months post procedure.|12 months post-procedure|Effectiveness analysis population, which consists of enrolled subjects without enrollment deviation and experiencing technical success. Technical success is defined as the investigational catheter being successfully inserted into the femoral artery with radiofrequency energy successfully applied in at least one artery.||percentage of participants|||Number
648813|NCT02095691|Secondary|Mean Change in Office Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 1 ,3, 6 and 12 Months Post Procedure|Office systolic blood pressure (SBP) and diastolic blood pressure (DBP) measures were summarized to assess the reduction in blood pressure from baseline visit to post baseline at 1, 3, 6, and 12 months. Negative values for change represent reductions.|12 months post-procedure|Effectiveness analysis population, which consists of enrolled subjects without enrollment deviation and experiencing technical success. Technical success is defined as the investigational catheter being successfully inserted into the femoral artery with radiofrequency energy successfully applied in at least one artery.||mmHg||Standard Deviation|Mean
648814|NCT02095691|Secondary|Incidence of Adverse Cardiovascular and Renal Events Within the 12 Month Follow-up Visit|These adverse events include renal artery stenosis (≥60% diameter reduction confirmed by MRI or renal angiography); peri-procedural renal artery dissection or perforation requiring intervention, serious arterial access site related complications requiring intervention or prolonging hospitalization; ≥25% reduction between baseline and 12 months in renal function measured by the estimated Glomerular Filtration Rate (eGFR), as well as composite of major adverse cardiovascular and/or renal events.|12 months post-procedure|The safety analysis population consists of all enrolled subjects who have undergone insertion of the study ablation catheter.||percentage of participants|||Number
649105|NCT02091752|Secondary|Change From Baseline in Spleen Length and Spleen Volume||Baseline, Week 24|The study was terminated early due to low enrollment. Analysis was not done.|||||
659067|NCT01888900|Secondary|Sustained Virological Responder|sustained virological response at follow-up week 12|Week 12 post treatment|||Participants|||Count of Participants
648815|NCT02095691|Primary|Incidence of Major Adverse Events That Occurred Within 30 Days Post-procedure.|Major adverse events include Acute myocardial infarction; Death from progressive heart failure, death from aortic or peripheral artery disease, from renal failure and sudden cardiac death; New-onset heart failure; Stroke; Aortic or lower limb revascularization procedure; Lower limb amputation; Beginning dialysis; Hospital admission for hypertensive emergency unrelated to non-adherence or non-persistence with drugs at each follow up visit; Hospitalization for atrial fibrillation.|30 days post-procedure|The Safety Analysis population which consists of all enrolled subjects who have undergone insertion of the study ablation catheter.||percentage of participants|||Number
648816|NCT02095561|Secondary|HPV Positivity|Calculated as the percentage of women with positive HPV test over total number of tested women, both for women with self-testing and those HPV tests taken at health centers.|within 6 months after the CHW visits|Population included in the HPV self-testing group to calculate positivity includes only women who were self-tested (n=2519). It excludes 99 women from this group who were not self-tested and were tested at health centers.||percentage of positive tests/tested wome|||Number
648817|NCT02095561|Secondary|CIN2+ Detection Rate|calculated as the percentage of women with histologically confirmed CIN2+ over total number of tested women, both for women with self-testing and those HPV tests taken at health centers.|within one year after the CHW visits|Population included in the HPV self-testing group to calculate CIN2+ detection rate includes only women who were self-tested (n=2519). It excludes 99 women from this group who were not self-tested and were tested at health centers.||percentage of CIN2+/ women screened|||Number
648818|NCT02095561|Secondary|Acceptability|Defined as the proportion of women from the intervention group who were offered self-testing and accepted, as documented in the questionnaire, independently of if they ended up with a test in the information system.|within 6 months|||participants|||Number
648819|NCT02095561|Primary|Screening Uptake|The primary outcome was screening uptake, defined as: a) the proportion of participant women with any HPV test (self-test or HPV at health centers) in the information system, in the 6 months after the CHW visit, and b) the proportion of women in the intervention group with a self-test in SITAM, in the same 6 month period.|within 6 months after the intervention|||participants|||Number
648820|NCT02095535|Primary|Length of Drying Time|Length of drying time from when Chloraprep solution is applied to skin to when skin is deemed dry.|At Chloraprep application|||seconds||Standard Deviation|Mean
648821|NCT02095223|Secondary|Change From Baseline in Quadriceps Hoffmann Reflex|We will record muscle reflex activity by delivering a short percutaneous (through the skin) electrical stimulation to femoral nerve located in the inguinal fold. We will measure the reflex response of the quadriceps with surface electromyography. Subjects will be positioned comfortably in a lying-down position on a treatment table. Stimuli will be delivered to the femoral nerve by increasing the intensity in small increments with a 10-sec rest interval after each stimulus, until the maximum H-reflex amplitude is recorded (Hmax). The H-reflex represents the proportion of the quadriceps motor neuron pool that is available for voluntary contraction and the M-wave represents the total volume of the quadriceps motor neuron pool and will be used to normalize the H-reflex recordings as H:M ratio. This measurement will be performed bilaterally.|Baseline and 14 days|This measure was exclude from the study protocol due to an issue with the equipment utilized to generate the electical pulse. No participants of this study completed the Hoffmann reflex testing protocol at baseline or follow-up visits.|||||
648822|NCT02095223|Primary|Change From Baseline in Quadriceps Central Activation Ratio|Subjects will be secured to a chair (Biodex multi-mode dynamometer) with their knees and hips bent to approximately 90-degrees. Subjects will perform a maximal, voluntary isometric knee extension contraction (MVIC) with continuous verbal encouragement from the tester. Once the MVIC reaches a plateau (representing subjects' maximal effort) an electrical stimulus will be manually triggered and delivered directly to the quadriceps through 2 stimulating electrodes which will be secured to the subjects' anterior thigh. The stimulus will cause the quadriceps to twitch resulting in a temporary increase in force production which we will measure. A ratio between the MVIC force and the highest force achieved due to the electrical stimulation will be calculated - this is called the central activation ratio.|Baseline and 14 days|||percentage change from baseline||Standard Deviation|Mean
648823|NCT02095197|Secondary|Greater Than or Equal to a 30% Reduction in Oswestry Neck Disability Index Score|This questionnaire has been designed to give us information to how neck pain has affected the ability to manage in everyday life. There are ten sections, 0 to 5 rating scale, in which zero means 'No pain' and 5 means 'Worst imaginable pain'. All the points can be summed to a total score. The maximum points scored is 50. The reported score divided by 50 is then transformed to a percentage score by multiplying by 100. The Minimum dectectable change (90 % confidence) is 5 points or 10 percent.|1 month|Both demonstrate a difference from pretreatment baseline (P=0.05).||Participants|||Count of Participants
648824|NCT02095197|Secondary|Patient Global Impression of Change Score (PGIC) Less Than 3|"PGIC is a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change as:
1=Very Much Improved, 2=Much Improved, 3=Minimally Improved, 4=No Change, 5=Minimally Worse, 6=Much Worse, 7=Very Much Worse.
A PGIC score less than 3 means the patient reported much improved to very much improved."|1 month|||Participants|||Count of Participants
648825|NCT02095197|Secondary|Decrease of > 6.8 Point Reduction in Medication Quntification Scale (MQS-III)|The Medication Quantification Scale was designed as a method of quantifying different drug regimens (Harden et al, Journal of Pain, 2005). The detriment weights derived from the healthcare survey for each of the 22 medication classes are the critical values that when multiplied by a dosage score it gives a patient MQS score. It computes a single numeric value for a patient's pain medication profile. We recorded the names and doses of each medication being used then quantified the total burden of each subject’s medication using the MQS-III. which assigns a measurement to each drug based on both the dose taken and its burdensomeness (derived from expert consensus).|1 month|||Participants|||Count of Participants
648826|NCT02095197|Primary|Percentage of Participants With ≥50% Pain Reduction on the Numeric Rating Score (NRS) for Pain|"The percentage of participants who reported ≥50% pain reduction on the numeric rating score for pain at the 1 month follow-up assessment period.
Numeric Rating Scale (NRS) for pain consists of a range where 0 (is no pain) and 10 (is extreme pain).
Percentage of participants with pain reduction = 100% (number of participants with pain reduction/all participants)"|1 month|||percentage of participants||95% Confidence Interval|Number
648827|NCT02095158|Secondary|Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Satisfaction Assessment (SSA) Using 5-Point Scales|The investigator assessed the participant’s overall severity of erythema in the treatment area by using the 5-point CEA scale with photonumeric guide where: 0=clear skin with no signs of erythema (best) to 4=severe erythema; fiery redness (worst). A decrease in the score indicates improvement. The participant assessed their overall severity of rosacea facial redness in the treatment area by using the 5-point SSA scale with photoguide where: 0=no signs of unwanted redness (best) to 4=severe redness (worst). A decrease in the score indicates improvement. The percentage of participants with at least a 2-grade decrease (improvement) on both CEA and SSA from Baseline was evaluated over the 6-hour evaluation period (hours 3 and 6) post-dose.|Baseline, Day 1 Hours 3 and 6, Week 4 Predose and Hours 3 and 6, Week 12 Predose, Week 26 Predose and Hours 3 and 6, Week 39 Predose, Week 52 Predose and Hours 3 and 6, Week 54 Predose|Modified-intent-to-treat (mITT) population consisted of all participants who had at least 1 post-baseline CEA and SSA measurement.||percentage of participants|||Number
648828|NCT02095158|Primary|Percentage of Participants With Treatment-Related Adverse Events|An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. A Treatment-Related Adverse Event is an Adverse Event determined by the investigator to be causally related to the study medication.|56 Weeks|Safety population included all participants who received at least 1 dose of study medication.||percentage of participants|||Number
648829|NCT02094937|Secondary|Proportion of Subjects With ACT Score >= 20 at Visit 11 (Week 20)|Asthma control test is a five item questionnaire with each response rating from 1 to 5 (1 is severe and 5 is no event) of asthma events over previous 4-weeks. The questions were designed to be self-completed by the participant. The percentage of participants with ACT score >=20 at the end of the Period 2 were analyzed using a logistic regression model including covariates for baseline ACT score, gender, age and treatment group.|Week 20|ITT population. Only those participants who completed the ACT score at the end of Period 2 (Visit 11) were evaluated.||Percentage of participants||95% Confidence Interval|Number
648830|NCT02094937|Secondary|Least Squares Mean Change From Baseline in Asthma Control Test (ACT) Score at the End of Period 2|The total ACT score is the sum of the scores attributed to the five questions, ranging from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. An ACT score >=20 indicates well-controlled asthma. The questions were designed to be self-completed by the participant. Mean change from Baseline was calculated as ACT score at the end of Period 2 (Week 20) minus Baseline value. The Baseline value was the predose value at randomization (Visit 5: Week 8). Adjusted mean change from baseline is presented [least square mean(LSM)].|Week 20|ITT population. Only those participants who completed the ACT score at the end of Period 2 (Visit 11) were evaluated.||Score on scale||Standard Error|Least Squares Mean
648831|NCT02094937|Secondary|Least Squares Mean Change From Baseline in the Percentage of Rescue Free 24 Hour (hr) Periods During Period 2|The time during which the participants did not have to take any rescue medication (medication intended to relieve symptoms immediately) was considered as a rescue free period. Participants who did not require inhalation of salbutamol (rescue medication) for 24-hours were captured with the help of a daily dairy, all participants were required to record use of rescue medication daily for day and night time separately on e-diary. Mean change from Baseline was calculated as percentage of rescue free 24 hour period during Period 2 (Week 9 to Week 20) minus Baseline value. The Baseline value was the mean of the daily values in one week prior to randomization (Visit 5: Week 8). Adjusted mean change from baseline is presented [least square mean (LSM)].|From Week 9 to Week 20|ITT population. Only those participants available at specified time point were analyzed||Percentage of rescue-free 24-hr periods||Standard Error|Least Squares Mean
648832|NCT02094937|Secondary|Least Squares Mean Change From Baseline in the Percentage of Symptom Free 24 Hour Periods During Period 2|Participants who were symptom free for 24-hours were assessed with the help of a daily Dairy. It included the details on daily asthma symptom scores ranging from 0 (no symptoms) to 5-symptoms so severe that participant could not perform normal activity [morning] or to 4-symptoms so severe that participants could not sleep at all [nightly]. Mean change from Baseline was calculated as percentage of symptom free 24 hours during Period 2 (Week 9 to Week 20) minus Baseline. The Baseline value was the mean of the daily values in one week prior to randomization (Visit 5: Week 8). Adjusted mean change from baseline is presented [least square mean (LSM)].|From Week 9 to Week 20|ITT population. Only those participants available at specified time point were analyzed||Percentage of symptom-free 24-h period||Standard Error|Least Squares Mean
648833|NCT02094937|Secondary|Least Squares Mean Change From Baseline in Daily Morning (AM) and Evening (PM) PEF Averaged During Period 2|Peak expiratory flow is a person's maximum speed of expiration, as measured with a peak flow meter which determines person's ability to breathe out air. PEF was measured each morning and evening prior to study medication or any rescue salbutamol inhalation aerosol use, using an electronic peak flow meter. Mean change from Baseline was calculated as PEF value averaged during Period 2 (Week 9 to Week 20) minus Baseline. Data is presented separately for morning(AM) and evening(PM) assessments. The Baseline value was the mean of the daily values in one week prior to randomization (Visit 5: Week 8) separately for morning and evening. Adjusted mean change from baseline is presented [least square mean (LSM)].|From Week 9 to Week 20|ITT population. Only those participants available at specified timepoints were analyzed||Liter per minute (L/min)||Standard Error|Least Squares Mean
648834|NCT02094937|Secondary|Least Squares Mean Change From Baseline in Clinic Visit Trough FEV1 at the End of Period 2|FEV measures amount of air a person can exhale during a forced breath. The amount of air exhaled in one second of the forced breath is FEV1. Trough FEV1 was measured between 3pm and 11pm excluding Visit 1. Highest value from the three acceptable measurements were recorded. Change from Baseline was calculated as adjusted mean FEV1 value during Period 2 minus Baseline. The Baseline value was the predose value at the randomization (Visit 5: Week 8). Analysis of covariance (ANCOVA) Model was used with covariates of baseline FEV1, gender, age and treatment group. The adjusted mean from this model is presented [least square mean (LSM)].|Week 20|ITT population. Number of participants available for the last post-baseline value during Period 2 were used for analysis.||Liter||Standard Error|Least Squares Mean
649106|NCT02091752|Secondary|Proportion of Patients Achieving ≥25% and ≥50% Reduction, Respectively From Baseline, in Spleen Length||Week 24|The study was terminated early due to low enrollment. Analysis was not done.|||||
648835|NCT02094937|Primary|Percentage of Participants With 'Well-controlled Asthma' at the End of Period 2|Asthma symptom scores(SS) were recorded by par using ratings 0 (no symptoms) to 5-symptoms so severe that par could not perform normal activity[morning] or to 4-symptoms so severe that par could not sleep at all[nightly]. “Well-controlled asthma” was defined as having no exacerbation/asthma worsening, no night-time symptoms, a best pre-bronchodilator forced expiratory volume in 1 second ≥80% at clinic, and ≥2 per week of: daytime symptoms on ≤1 day, rescue use on ≤1 day, or morning peak expiratory flow ≥80% of the best effort value. “Well-controlled asthma” at the end of period 2 was assessed in the week prior to Visit 11 (Week 20). Percentage of participants were calculated as the number of participants with “well-controlled asthma” divided by total number participants excluding withdrawals prior to visit 11 (end of period 2) other than asthma worsening/exacerbation. A Logistic Regression Model was used with covariates of Baseline FEV1, gender, age and treatment group.|Week 20|ITT population. Participants who withdrew prior to Visit 11 for the reasons other than exacerbation were excluded.||Percentage of Participants||95% Confidence Interval|Number
648836|NCT02094937|Primary|"Percentage of Participants (Par) Withdrawn From the Study Due to Poorly-controlled Asthma During Period 2"|Asthma symptom scores (SS) were recorded by par using ratings 0 (no symptoms) to 5-symptoms so severe that par could not perform normal activity [morning] or to 4-symptoms so severe that par could not sleep at all [nightly]. Withdrawal due to poorly-controlled(WPC) (required step-up therapy) asthma was defined as asthma worsening/exacerbation or ≧3 per week of : day symptoms on ≧ 2 days, rescue use on ≧2 days, morning PEF <80 % of best effort on ≧ 1 day, night symptoms on ≧1 or more day, a best pre-bronchodilator forced expiratory volume in 1s (FEV1) < 80% at clinic . Percentage of par WPC asthma at visit 6, 7, 9 and 11 (Week 10, 12, 16 and 20 respectively) were reported. Cox Proportional Hazards Model was used with covariates of Baseline FEV1, gender, age and treatment group. Analysis was descriptive only, no p -values calculated, treatment differences and associated 95% CI were produced.|From Week 9 to Week 20|Intent-to-treat (ITT) population defined as participants randomized to treatment and who received at least one dose of randomized study medication in Period 2.||Percentage of Participants||95% Confidence Interval|Number
648837|NCT02094898|Secondary|CGI-S Score, Percentage Change From Baseline at Last Acute Phase Observation|The Clinical Global Impression Severity Subscale is an observer rated scale that measures illness severity. It has a range of responses from 1 (normal) through to 7 (among the most extremely ill patients).|baseline, last acute phase observation (approximately 2 weeks)|Statistical analyses included all subjects who received at least one acute-phase ketamine infusion.||percentage change in score||Standard Deviation|Mean
648838|NCT02094898|Secondary|Clinical Global Impression-severity Subscale (CGI-S) at Baseline and Last Acute Phase Observation|The Clinical Global Impression Severity Subscale is an observer rated scale that measures illness severity. It has a range of responses from 1 (normal) through to 7 (among the most extremely ill patients).|baseline, last acute phase observation (approximately 2 weeks)|Statistical analyses included all subjects who received at least one acute-phase ketamine infusion.||units on a scale||Standard Deviation|Mean
648839|NCT02094898|Secondary|MADRS Suicide (Item 10) Score, Percentage Change From Baseline at Last Acute Phase Observation|The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. Item 10 scores can range from 0 to 6 (with 0 indicating enjoying life, and 6 indicating explicit plans for suicide.)|baseline, last acute phase observation (approximately 2 weeks)|Statistical analyses included all subjects who received at least one acute-phase ketamine infusion.||percentage change in score||Standard Deviation|Mean
648840|NCT02094898|Secondary|MADRS Suicide Thoughts (Item 10) Score at Last Acute Phase Observation|The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. Item 10 scores can range from 0 to 6 (with 0 indicating enjoying life, and 6 indicating explicit plans for suicide.)|baseline, last acute phase observation (approximately 2 weeks)|Statistical analyses included all subjects who received at least one acute-phase ketamine infusion.||units on a scale||Standard Deviation|Mean
648841|NCT02094898|Secondary|MADRS Factor 4 Score, Percentage Change From Baseline at Last Acute Phase Observation|The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. MADRS Factor 4 (neurovegetative symptoms) consisted of MADRS items 3-5 (Inner Tension, Reduced Sleep, and Reduced Appetite). The MADRS Factor 4 Score is derived by adding all the scores from the 3 items, meaning the lowest possible score is 0 and the highest possible is 18.|baseline, last acute phase observation (approximately 2 weeks)|Statistical analyses included all subjects who received at least one acute-phase ketamine infusion.||percentage change in score||Standard Deviation|Mean
648842|NCT02094898|Secondary|MADRS Factor 4 Score at Baseline and Last Acute Phase Observation|The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. MADRS Factor 4 (Neurovegetative Symptoms) consisted of MADRS items 3-5 (Inner Tension, Reduced Sleep, and Reduced Appetite). The MADRS Factor 4 Score is derived by adding all the scores from the 3 items, meaning the lowest possible score is 0 and the highest possible is 18.|baseline, last acute phase observation (approximately 2 weeks)|Statistical analyses included all subjects who received at least one acute-phase ketamine infusion||units on a scale||Standard Deviation|Mean
648843|NCT02094898|Secondary|MADRS Factor 3 Score, Percentage Change From Baseline at Last Acute Phase Observation|The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. MADRS Factor 3 (detachment) consisted of MADRS items 6 - 8 (Concentration Difficulties, Lassitude, and Inability to Feel). The MADRS Factor 3 Score is derived by adding all the scores from the 3 items, meaning the lowest possible score is 0 and the highest possible is 18.|baseline, last acute phase observation (approximately 2 weeks)|Statistical analyses included all subjects who received at least one acute-phase ketamine infusion.||percentage change in score||Standard Deviation|Mean
648844|NCT02094898|Secondary|MADRS Factor 3 Score at Baseline and Last Acute Phase Observation|The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. MADRS Factor 3 (Detachment) consisted of MADRS items 6 - 8 (Concentration Difficulties, Lassitude, and Inability to Feel). The MADRS Factor 3 Score is derived by adding all the scores from the 3 items, meaning the lowest possible score is 0 and the highest possible is 18.|baseline, last acute phase observation (approximately 2 weeks)|Statistical analyses included all subjects who received at least one acute-phase ketamine infusion.||units on a scale||Standard Deviation|Mean
648845|NCT02094898|Secondary|MADRS Factor 2 Score, Percentage Change From Baseline at Last Acute Phase Observation|The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. MADRS Factor 2 (negative thoughts) consisted of MADRS items 9 (Pessimistic Thoughts) and 10 (Suicidal Thoughts). The MADRS Factor 2 Score is derived by adding all the scores from the 2 items, meaning the lowest possible score is 0 and the highest possible is 12.|baseline, last acute phase observation (approximately 2 weeks)|Statistical analyses included all subjects who received at least one acute-phase ketamine infusion.||percentage change in score||Standard Deviation|Mean
648846|NCT02094898|Secondary|MADRS Factor 2 Score at Baseline and Last Acute Phase Observation|The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. MADRS Factor 2 (Negative Thoughts) consisted of MADRS items 9 (Pessimistic Thoughts) and 10 (Suicidal Thoughts). The MADRS Factor 2 Score is derived by adding all the scores from the 2 items, meaning the lowest possible score is 0 and the highest possible is 12.|baseline, last acute phase observation (approximately 2 weeks)|Statistical analyses included all subjects who received at least one acute-phase ketamine infusion.||units on a scale||Standard Deviation|Mean
648847|NCT02094898|Secondary|MADRS Factor 1 Score, Percent Change From Baseline at Last Acute Phase Observation|The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. MADRS Factor 1 (Sadness) consisted of MADRS items 1 (Apparent Sadness) and 2 (Reported Sadness). The MADRS Factor 1 Score is derived by adding all the scores from the 2 items, meaning the lowest possible score is 0 and the highest possible is 12.|baseline, last acute phase observation|Statistical analyses included all subjects who received at least one acute-phase ketamine infusion.||percentage change in score||Standard Deviation|Mean
648848|NCT02094898|Secondary|MADRS Factor 1 Score at Baseline and Last Acute Phase Observation|The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. MADRS Factor 1 (Sadness) consisted of MADRS items 1 (Apparent Sadness) and 2 (Reported Sadness). The MADRS Factor 1 Score is derived by adding all the scores from the 2 items, meaning the lowest possible score is 0 and the highest possible is 12.|baseline, last acute phase observation (approximately 2 weeks)|Statistical analyses included all subjects who received at least one acute-phase ketamine infusion.||units on a scale||Standard Deviation|Mean
648849|NCT02094898|Secondary|MADRS Total Score, Percent Change From Baseline at Last Acute Phase Observation|The Montgomery Asberg Depression Scale (MADRS) is a 10-item observer rating scale assessing symptoms of depression. The score ranges from 0 (no depression) to 60 (very depressed). For this study a score of less than or equal to 9 was considered clinical remission of depression.|baseline, last acute phase observation (approximately 2 weeks)|Statistical analyses included all subjects who received at least one acute-phase ketamine infusion.||percentage change in score||Standard Deviation|Mean
648850|NCT02094898|Primary|MADRS Total Score at Baseline and Last Acute Phase Observation|The Montgomery Asberg Depression Scale (MADRS) is a 10-item observer rating scale assessing symptoms of depression. The score ranges from 0 (no depression) to 60 (very depressed). For this study a score of less than or equal to 9 was considered clinical remission of depression.|baseline, last acute phase observation (approximately 2 weeks)|Statistical analyses included all subjects who received at least one acute-phase ketamine infusion.||units on a scale||Standard Deviation|Mean
648851|NCT02094885|Secondary|Incidence of Potential Bleeding-related Adverse Events.||30-days follow-up|||percentage of participants||95% Confidence Interval|Number
648852|NCT02094885|Secondary|Incidence of Treatment Failures.||Intra-operative, 10 minutes following randomization|||participants|||Number
648853|NCT02094885|Secondary|Hemostasis at the TBS at 3 and 6 Minutes Following the Completion of Treatment Application||Intra-operative, 3 and 6 minutes following randomization|||percentage of participants||95% Confidence Interval|Number
648854|NCT02094885|Primary|Hemostasis at the TBS at 10 Minutes Following the Completion of Treatment Application.||Intra-operative, 10 minutes following randomization|||percentage of patients||95% Confidence Interval|Number
648855|NCT02094677|Secondary|Ocular Health, Conjunctival Hyperemia – Filcon II 3 and Nelfilcon A|The ophthalmologist’s objective assessment of conjunctival bulbar and limbal hyperemia assessed at screening (before lens insertion of filcon II 3 and nelfilcon A) by biomicroscopy (Scale 0-4, 0.5 increments, 0=no redness, 4=redness).|Baseline and 6 hours|These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants.||units on a scale||Standard Deviation|Mean
648856|NCT02094677|Secondary|Ocular Health, Conjunctival Hyperemia – Filcon II 3 and Etafilcon A|The ophthalmologist’s objective assessment of conjunctival bulbar and limbal hyperemia assessed at screening (before lens insertion) by biomicroscopy (Scale 0-4, 0.5 increments, 0=no redness, 4=redness).|Baseline and 6 hours|These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants.||units on a scale||Standard Deviation|Mean
648857|NCT02094677|Secondary|Ocular Health, Corneal Staining (Extent) – Filcon II 3 and Nelfilcon A|"The ophthalmologist’s objective assessment of corneal staining (extent) assessed at 6 hours by biomicroscopy (Grade as a % of each zone).
N - Nasal, T - Temporal, S - Superior, I - Interior, C - Central"|6 hours|These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants.||percentage of the area of each zone||Standard Deviation|Mean
648858|NCT02094677|Secondary|Ocular Health, Corneal Staining (Extent) – Filcon II 3 and Etafilcon A|"The ophthalmologist’s objective assessment of corneal staining (extent) assessed at screening (before lens insertion) by biomicroscopy (Grade as a % of each zone).
N - Nasal, T - Temporal, S - Superior, I - Interior, C - Central"|6 hours|These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants.||percentage of the area of each zone||Standard Deviation|Mean
648859|NCT02094677|Secondary|High Contrast Visual Acuity – Filcon II 3 and Nelfilcon A|The ophthalmologist's objective assessment of High Contrast Visual Acuity following filcon II 3 and nelfilcon A insertion (assessed at baseline visit and 6 hours) by computerized charts. (Positive logMAR values indicate poorer vision, negative values denote better vision than baseline 20/20 value)|Baseline and 6 hours|These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants.||logMAR||Standard Deviation|Mean
649107|NCT02091752|Secondary|Proportion of Patients Achieving ≥35% Reduction From Baseline in Spleen Volume||Week 24|The study was terminated early due to low enrollment. Analysis was not done.|||||
648860|NCT02094677|Secondary|High Contrast Visual Acuity – Filcon II 3 and Etafilcon A|The ophthalmologist's objective assessment of High Contrast Visual Acuity following filcon II 3 and etafilcon A insertion (assessed at baseline visit and 6 hours) by computerized charts. (Positive logMAR values indicate poorer vision, negative values denote better vision than baseline 20/20 value).|Baseline and 6 hours|These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants.||logMAR||Standard Deviation|Mean
648861|NCT02094677|Secondary|Lens Surface Deposition – Filcon II 3 and Nelfilcon A|The ophthalmologist’s objective assessment for lens surface deposition of filcon II 3 and nelfilcon A following insertion (assessed at 6 hour visit) by biomicroscopy (Scale 0-4, 0.25 steps, 0=no deposits, 4=severe deposits).|6 hour|These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants.||units on a scale||Standard Deviation|Mean
648862|NCT02094677|Secondary|Lens Surface Deposition – Filcon II 3 and Etafilcon A|The ophthalmologist’s objective assessment for lens surface deposition of filcon II 3 and etafilcon A following insertion (assessed at 6 hour visit) by biomicroscopy (Scale 0-4, 0.25 steps, 0=no deposits, 4=severe deposits).|6 hour|These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants.||units on a scale||Standard Deviation|Mean
648863|NCT02094677|Secondary|Lens Fit, Tightness – Filcon II 3 and Nelfilcon A|The ophthalmologist’s objective assessment for lens fit for tightness of filcon II 3 and nelfilcon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (Percentage of tightness, 5 increments, 0-100, 0=extremely loose, 100=extremely tight).|Baseline and 6 hours|These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants.||percentage of tightness||Standard Deviation|Mean
648864|NCT02094677|Secondary|Lens Fit, Tightness – Filcon II 3 and Etafilcon A|The ophthalmologist’s objective assessment for lens fit for tightness of filcon II 3 and etafilcon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (Percentage of tightness, 5 increments, 0-100, 0=extremely loose, 100=extremely tight).|Baseline and 6 hours|These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants.||percentage of tightness||Standard Deviation|Mean
648865|NCT02094677|Secondary|Lens Fit, Post-Blink Movement – Filcon II 3 and Nelfilcon A|The ophthalmologist’s objective assessment for lens fit for Post-Blink Movement of filcon II 3 and nelfilcon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (measured in Primary Gaze and recorded in 0.1mm steps).|Baseline and 6 hours|These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants.||mm steps||Standard Deviation|Mean
648866|NCT02094677|Secondary|Lens Fit, Post-Blink Movement – Filcon II 3 and Etafilcon A|The ophthalmologist’s objective assessment for lens fit for Post-Blink Movement of filcon II 3 and etafilcon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (measured in Primary Gaze and recorded in 0.1mm steps).|Baseline and 6 hours|These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants.||mm steps||Standard Deviation|Mean
648867|NCT02094677|Secondary|Lens Fit, Centration - Filcon II 3 and Nelfilcon A|The ophthalmologist's objective assessment for lens fit for centration of filcon II 3 and nelfilcon A following insertion (assessed at 6 hours) by biomicroscopy (Optimum or Decentered N T S I) N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior, T/I - Temporal/Interior|After 6 hours|These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants.||participants|||Number
648868|NCT02094677|Secondary|Lens Fit, Centration - Filcon II 3 and Nelfilcon A|The ophthalmologist's objective assessment for lens fit for centration of filcon II 3 and nelfilcon A following insertion (assessed at baseline) by biomicroscopy (Optimum or Decentered N T S I) N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior, T/I - Temporal/Interior|Baseline|These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants.||participants|||Number
648869|NCT02094677|Secondary|Lens Fit, Centration - Filcon II 3 and Etafilcon A|The ophthalmologist's objective assessment for lens fit for centration of filcon II 3 and etafilcon A following insertion (assessed at 6 hours) by biomicroscopy (Optimum or Decentered N T S I) N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior, T/I - Temporal/Interior|6 hours|These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants.||participants|||Number
648870|NCT02094677|Secondary|Lens Fit, Centration - Filcon II 3 and Etafilcon A|"The ophthalmologist's objective assessment for lens fit for centration of filcon II 3 and etafilcon A following insertion (assessed at baseline visit) by biomicroscopy (Optimum or Decentered N T S I).
N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior T/I - Temporal/Interior"|Baseline|These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants.||participants|||Number
648871|NCT02094677|Secondary|Lens Wettability – Filcon II 3 and Nelfilcon A|The ophthalmologist’s objective assessment for lens wettability of filcon II 3 and nelficon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (Scale 0-4, 0.25 increments, 0=excellent wettability, 4=severely reduced wettability).|Baseline and 6 hours|These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants.||units on a scale||Standard Deviation|Mean
648872|NCT02094677|Secondary|Lens Wettability – Filcon II 3 and Etafilcon A|The ophthalmologist’s objective assessment for lens wettability of filcon II 3 and etafilcon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (Scale 0-4, 0.25 increments, 0=excellent wettability, 4=severely reduced wettability).|Baseline and 6 hours|These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants.||units on a scale||Standard Deviation|Mean
648873|NCT02094677|Secondary|Lens Handling (Removal) – Filcon II 3 and Nelfilcon A|Participant’s subjective response for lens handling of filcon II 3 and nelfilcon A following removal (surveyed 6 hours after baseline visit) rated by questionnaire (Scale 0-100, 0=very hard to handle, causes pain, 100=very easy to handle).|6 hours|These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants. Habitual data collected before study lens dispensed.||units on a scale||Standard Deviation|Mean
649108|NCT02091752|Primary|Proportion of Patients Achieving ≥20% Reduction From Baseline in Spleen Volume||Week 24|The study was terminated early due to low enrollment. Analysis was not done.|||||
648874|NCT02094677|Secondary|Lens Handling (Removal) – Filcon II 3 and Etafilcon A|Participant’s subjective response for lens handling of filcon II 3 and etafilcon A following insertion (surveyed 6 hours after baseline visit) rated by questionnaire (Scale 0-100, 0=very hard to handle, causes pain, 100=very easy to handle).|6 hours|These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants. Habitual data collected before study lens dispensed.||units on a scale||Standard Deviation|Mean
648875|NCT02094677|Secondary|Lens Handling – Filcon II 3 and Nelfilcon A|Participant’s subjective response for lens handling of filcon II 3 and nelfilcon A following insertion (surveyed at baseline visit) rated by questionnaire (Scale 0-100, 0=very hard to handle, causes pain, 100=very easy to handle).|Baseline visit|These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants. Habitual data collected before study lens dispensed.||units on a scale||Standard Deviation|Mean
648876|NCT02094677|Secondary|Lens Handling – Filcon II 3 and Etafilcon A|Participant’s subjective response for lens handling of filcon II 3 and etafilcon A following insertion (surveyed at baseline visit) rated by questionnaire (Scale 0-100, 0=very hard to handle causes pain, 100=very easy to handle).|Baseline visit|These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants. Habitual data collected before study lens dispensed.||units on a scale||Standard Deviation|Mean
648877|NCT02094677|Secondary|Lens Dryness - Filcon II 3 and Nelfilcon A|Participant's subjective response for lens dryness of filcon II 3 and nelfilcon A (surveyed at 3 and 6 hours after baseline visit) rated by questionnaire (Scale 0-100, 0=cannot be worn, extremely dry, 100=no dryness experienced).|3 hours and 6 hours|These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants. Habitual data collected before study lens dispensed.||units on a scale||Standard Deviation|Mean
648878|NCT02094677|Secondary|Lens Dryness – Filcon II 3 and Etafilcon A|Participant’s subjective response for lens dryness of filcon II 3 and etafilcon A (surveyed at 3 and 6 hours after baseline visit) rated by questionnaire (Scale 0-100, 0=cannot be worn, extremely dry 100=no dryness experienced).|3 hours and 6 hours|These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants. Habitual data collected before study lens dispensed.||units on a scale||Standard Deviation|Mean
648879|NCT02094677|Secondary|Lens Comfort - Filcon II 3 and Nelficon A|Participant's subjective response for lens comfort of filcon II 3 and nelfilcon A after settling 10-15mins (surveyed at baseline visit, 3 hours, and 6 hours) rated by questionnaire (Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever).|Baseline, 3 hours, 6 hours|These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants. Habitual data collected before study lens dispensed.||units on a scale||Standard Deviation|Mean
648880|NCT02094677|Secondary|Lens Comfort - Filcon II 3 and Etafilcon A|Participant's subjective response for lens comfort of filcon II 3 and etafilcon A after settling 10-15mins (surveyed at baseline visit, 3 hours, and 6 hours) rated by questionnaire (Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever).|Baseline, 3 hours, 6 hours|These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants. Habitual data collected before study lens dispensed.||units on a scale||Standard Deviation|Mean
648881|NCT02094677|Primary|Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A|Participant's subjective response for lens preference of filcon II 3 and etafilcon A after 6 hours lens wear rated by questionnaire (5 possible ratings: Strongly prefer filcon II 3, Slightly prefer filcon II 3, No preference, Slightly prefer etafilcon A/nelfilcon A, Strongly prefer etafilcon A/nelfilcon A).|6 hours|||participants|||Number
648882|NCT02094677|Primary|Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A|Participant's subjective response for lens preference of filcon II 3 and etafilcon A after 3 hours lens wear rated by questionnaire. (5 possible ratings: Strongly prefer filcon II 3, Slightly prefer filcon II 3, No preference, Slightly prefer etafilcon A/nelfilcon A, Strongly prefer etafilcon A/nelfilcon A).|3 hours|||participants|||Number
648883|NCT02094677|Primary|Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A|"Participant's subjective response for lens preference of filcon II 3 and etafilcon A or filcon II 3 and nelfilcon A at baseline visit, following insertion, after settling 10-15mins (surveyed at baseline visit) rated by questionnaire.
(5 possible ratings: Strongly prefer filcon II 3, Slightly prefer filcon II 3, No preference, Slightly prefer etafilcon A/nelfilcon A, Strongly prefer etafilcon A/nelfilcon A)."|Baseline visit|||participants|||Number
648884|NCT02094612|Secondary|Other Health Services Use|"Update: Outcome measure reported is number of psychiatric and ED visits during the 6 month follow up period.
Use of healthcare services outside of pediatrics, including the emergency room and psychiatric services."|Baseline to six months|||visits|||Number
648885|NCT02094612|Secondary|Satisfaction With Care|"Update: Outcome measure reported is number of participants who responded very satisfied with their ADHD care on 5-point Likert scale.
Likert scale single item measure of how satisfied the pediatric patient's parent was with care received"|Six months|||Participants|||Count of Participants
648886|NCT02094612|Secondary|Medication Adherence|"Update: Outcome reported is number of participants taking medication as prescribed at all study follow up visits.
Sustained use of ADHD medication"|Baseline to six months|||Participants|||Count of Participants
648887|NCT02094612|Secondary|Persistence in Care|"Update: Outcome measure reported is the # of participants who attended all study follow-up visits.
Use of pediatric health care services"|Baseline to Six Months|||Participants|||Count of Participants
648888|NCT02094612|Secondary|Academic Performance|Academic performance will be measured by student report cards, and converted to a standardized scale|Baseline and Six Months|Academic performance was not measured, as there were a very low number of report cards collected (11 of 25 in Quotient arm and 16 of 33 in UC arm).|||||
648889|NCT02094612|Secondary|ADHD Symptomatology|"Outcomes reported are average SNAP IV scores at baseline and 6 monhts. ADHD symptomatology is measured by the Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV), developed by James Swanson, Edith Nolan and William Pelham. We used the 18-item self-report inventory designed to measure attention deficit hyperactivity disorder (ADHD) symptoms in children and young adults. Each question measures the frequency of a variety of symptoms or behaviors.The subscales measure Inattention (9 items) and Hyperactivity/impulsivity (9 items), using 0-3 rating, 0=not at all, 1=just a little, 2=quite a bit, or 3=very much. Each 9-item subscale results in a score in range 0-27. The two subscale scores were averaged to create a single score for the 18-item SNAP."|6 months post baseline|||Score on a scale||Standard Deviation|Mean
648890|NCT02094612|Primary|Number of Participants With 25% Reduction in SNAP Scores|Outcome measure reported is the number of participants with at least one 25% reduction in SNAP between visits. In treatment of ADHD, the therapeutic dose is defined as a 25% reduction in SNAP IV score between consecutive clinic visits. SNAP is itemized rating scale (Swanson, Nolan, and Pelham-IV Questionnaire) designed to measure ADHD symptoms and severity on a 4 point scale. It is based on DSM IV criteria, and is designed to measure attention deficit hyperactivity disorder (ADHD) and oppositional defiant disorder (ODD) symptoms in children and young adults ages 6–18.|One month, 3 month and six month follow ups|Fifty eight (58) participants completed the study (i.e., had their 6 month follow up appointment) when the study was terminated.||Participants|||Count of Participants
648891|NCT02094573|Secondary|Patient-reported Symptoms Global Health Status/Quality of Life (QoL) Scores|"Patient-reported symptoms global health status/quality of life (QoL) scores were based on questions 29 and 30 of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-C30 (QLQ-C30). The first 28 questions used 4-point scale (1=not at all,2=a little,3=quite a bit,4=very much) for evaluating 5 functional scales (physical, role, cognitive, emotional, and social functioning); 3 symptom scales (fatigue, pain, and nausea/vomiting); and last 2 questions on global health status/QoL scale are coded on 7-point scale (1=very poor to 7=excellent). Six single-item scales also are included (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Raw scores for multi-item scales and single-item measures will be linearly transformed to obtain the score ranging from 0 to 100, where higher score represents a higher (better) level of functioning."|Up to 30 days after the last dose of study drug or up to data cut-off date: 29 Feb 2016 (approximately up to 20 months)|ITT Population included all participants who were randomized to each regimen regardless of whether they received study drug or adhered to the assigned dose. Here, n represents number of participants who were evaluable at specific time point.||unit on a scale||Standard Deviation|Mean
648892|NCT02094573|Secondary|Pre-dose Brigatinib Plasma Concentration||Day 1 Cycle 1 pre-dose; Cycle 2 pre-dose and at multiple time points (up to 6-8 hours) post dose; Cycles 3, 4 and 5 pre-dose and at 1-8 hours post dose|ITT Population included all participants who were randomized to each regimen regardless of whether they received study drug or adhered to the assigned dose. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.||ng/ml||Standard Deviation|Mean
648893|NCT02094573|Secondary|Number of Participants Who Had at Least One Treatment-Emergent Adverse Event (TEAE)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|From first dose of study drug up to 30 days following the last dose of study drug (up to 20 months)|Safety population included all participants who received at least one dose of study drug.||participants|||Number
648894|NCT02094573|Secondary|Overall Survival (OS)|OS is defined as the time interval from the date of the first dose of the study treatment until death due to any cause. Intracranial OS was calculated by Kaplan-Meier estimation.|Up to data cut-off date: 29 Feb 2016 (approximately up to 20 months)|ITT Population included all participants who were randomized to each regimen regardless of whether they received study drug or adhered to the assigned dose.||months||95% Confidence Interval|Median
648895|NCT02094573|Secondary|Progression Free Survival (PFS)|PFS is defined as the time interval from the date of the first dose of the study treatment until the first date at which disease progression is objectively documented, or death due to any cause, whichever occurs first. Disease progression for target lesion: SLD increased by at least 20% from the smallest value on study (including baseline, if that is the smallest) and SLD must also demonstrate an absolute increase of at least 5 mm or development of any new lesion. Disease progression for non-target lesion: Unequivocal progression of existing non-target lesions. (Subjective judgment by experienced reader).|Up to data cut-off date: 29 Feb 2016 (approximately up to 20 months)|ITT Population included all participants who were randomized to each regimen regardless of whether they received study drug or adhered to the assigned dose.||months||95% Confidence Interval|Median
648896|NCT02094573|Secondary|Disease Control Rate|Disease control rate (DCR) is defined as the proportion of randomized participants who were confirmed to have achieved CR or PR or have a best overall response as stable disease (SD) for 6 weeks or more after initiation of the study drug. CR for target lesion: disappearance of all extranodal lesions and all pathological lymph nodes must have decreased to <10 mm in short axis. CR for non-target lesion: Disappearance of all extranodal non-target lesions, all lymph nodes must be non-pathological in size (<10mm short axis) and norrmalization of tumor marker level. PR: at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD).|Screening, at 8-week intervals thereafter (on Day 1 of every odd-numbered cycle) through 15 cycles and every 3 cycles thereafter until disease progression or up to data cut-off date: 29 Feb 2016 (approximately up to 20 months)|ITT Population included all participants who were randomized to each regimen regardless of whether they received study drug or adhered to the assigned dose.||percentage of participants||95% Confidence Interval|Number
648897|NCT02094573|Secondary|Time on Treatment|Time on treatment is defined as the time from the first to the last dose of study drug. For participants who have not discontinued, time on treatment was censored as of the last dose of the study drug.|Up to data cut-off date: 29 Feb 2016 (approximately up to 20 months)|Safety population included all participants who received at least one dose of study drug.||days||Standard Deviation|Mean
648923|NCT02094300|Primary|Number of Patients With Major Complications|Major complication is defined as: Retrograde dissection, cardiac events requiring surgical management, prolonged ventilation requiring tracheotomy, renal failure requiring dialysis (where not previously needed), aortic fistula, mesenteric ischemia requiring surgical management, paralysis or paraparesis unresolved after 30 days of therapy, pulmonary embolism, stroke, and multi-system organ failure, unless related to presenting condition.|30 days|There were 8 patients experienced 30-day major complications.||participants|||Number
648940|NCT02093923|Secondary|Apparent Clearance (CL/F)||Pharmacokinetic samples were drawn on Days 1, 2, 4, 8, 15, 16, 18, 22, 29, 36, 50, 64, 92, and 120.|All randomized HAE subjects who received at least 1 dose of DX-2930 and who have sufficient blood samples for pharmacokinetic analyses. Results from placebo-treated subjects were not analyzed for summary statistics since these subjects did not have detectable drug levels.||liters/day||Standard Deviation|Mean
648898|NCT02094573|Secondary|Duration of Response|Duration of response is defined as the time interval from the time that the measurement criteria are first met for CR/PR (whichever is first recorded) until the first date that the progressive disease is objectively documented or death. Patients without progressive disease or death were censored at the last valid response assessment. CR for target lesion: disappearance of all extranodal lesions and all pathological lymph nodes must have decreased to <10 mm in short axis. CR for non-target lesion: Disappearance of all extranodal non-target lesions, all lymph nodes must be non-pathological in size (<10mm short axis) and norrmalization of tumor marker level. PR: at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline sum diameters.|Up to data cut-off date: 29 Feb 2016 (approximately up to 20 months)|ITT Population included all participants who were randomized to each regimen regardless of whether they received study drug or adhered to the assigned dose. Participants who had confirmed CR or PR were evaluable for this outcome measure.||months||95% Confidence Interval|Median
648899|NCT02094573|Secondary|Time to Response|Time to response is defined as the time interval from the date of the first dose of the study drug until the initial observation of CR or PR for participants with confirmed CR/PR. CR for target lesion: disappearance of all extranodal lesions and all pathological lymph nodes must have decreased to <10 mm in short axis. CR for non-target lesion: Disappearance of all extranodal non-target lesions, all lymph nodes must be non-pathological in size (<10mm short axis) and norrmalization of tumor marker level. PR: at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline sum diameters.|Up to data cut-off date: 29 Feb 2016 (approximately up to 20 months)|ITT Population included all participants who were randomized to each regimen regardless of whether they received study drug or adhered to the assigned dose. Participants who had confirmed CR or PR were evaluable for this outcome measure.||months||Full Range|Median
648900|NCT02094573|Secondary|Intracranial CNS Progression Free Survival (PFS) in Participants With Active Brain Metastases|Intracranial CNS PFS as evaluated by IRC is defined as the time interval from the date of the first dose of the study drug until the first date at which intracranial CNS disease progression, an increase of 20% or more in the sum of diameters of intracranial CNS target lesions, unequivocal progression of non-target lesions, or the appearance of new lesions in the intracranial CNS, was objectively documented by a scan, or death due to any cause, whichever occurred first.|Screening, at 8-week intervals thereafter (on Day 1 of every odd-numbered cycle) through 15 cycles and every 3 cycles thereafter until disease progression or up to data cut-off date: 29 Feb 2016 (approximately up to 20 months)|ITT Population included all participants who were randomized to each regimen regardless of whether they received study drug or adhered to the assigned dose. Participants with active brain metastases at baseline were evaluated for this outcome measure.||months||95% Confidence Interval|Median
648901|NCT02094573|Secondary|Confirmed Intracranial Central Nervous System Objective Response Rate (CNS ORR) in Participants With Only Non-measurable Active Brain Metastases|Confirmed intracranial CNS ORR is defined as the proportion of the participants with CR or PR in the intracranial CNS per modification of RECIST v1.1 as evaluated by IRC after the initiation of study drug. Confirmed responses were those that persisted on repeat imaging 4 weeks or more after initial response. CR for target lesion: disappearance of all extranodal non-target lesions, all lymph nodes must be non-pathological in size (<10mm short axis). CR for non-target lesion: disappearance of all extranodal non-target lesions, all lymph nodes must be non-pathological in size (<10mm short axis) and norrmalization of tumor marker level. PR: at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline sum diameters.|Screening, at 8-week intervals thereafter (on Day 1 of every odd-numbered cycle) through 15 cycles and every 3 cycles thereafter until disease progression or up to data cut-off date:29 Feb 2016 (approximately up to 20 months)|ITT Population included all participants who were randomized to each regimen regardless of whether they received study drug or adhered to the assigned dose. Participants with only non-measurable active brain metastases at baseline were evaluated for this outcome measure.||percentage of participants||95% Confidence Interval|Number
648902|NCT02094573|Secondary|Confirmed Intracranial Central Nervous System Objective Response Rate (CNS ORR) in Participants With Measurable Active Brain Metastases|Confirmed intracranial CNS ORR is defined as the proportion of the participants with CR or PR in the intracranial CNS per modification of RECIST v1.1 as evaluated by IRC after the initiation of study drug. Confirmed responses were those that persisted on repeat imaging 4 weeks or more after initial response. CR for target lesion: disappearance of all extranodal non-target lesions, all lymph nodes must be non-pathological in size (<10mm short axis). CR for non-target lesion: disappearance of all extranodal non-target lesions, all lymph nodes must be non-pathological in size (<10mm short axis) and norrmalization of tumor marker level. PR: at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline sum diameters.|Screening, at 8-week intervals thereafter (on Day 1 of every odd-numbered cycle) through 15 cycles and every 3 cycles thereafter until disease progression or up to data cut-off date:29 Feb 2016 (approximately up to 20 months)|ITT Population included all participants who were randomized to each regimen regardless of whether they received study drug or adhered to the assigned dose. Participants with measurable active brain metastases at baseline were evaluated for this outcome measure.||percentage of participants||95% Confidence Interval|Number
648903|NCT02094573|Secondary|Confirmed Objective Response Rate (ORR) as Assessed by Independent Review Committee (IRC)|ORR assessed by the IRC, is defined as the proportion of the participants with confirmed Clinical response (CR) or partial response (PR) according to RECIST v1.1 (confirmed ≥4 weeks after initial response), after the initiation of study treatment. CR for target lesion: disappearance of all extranodal lesions and all pathological lymph nodes must have decreased to <10 mm in short axis. CR for non-target lesion: Disappearance of all extranodal non-target lesions, all lymph nodes must be non-pathological in size (<10mm short axis) and norrmalization of tumor marker level. PR: at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline sum diameters. The exact 2-sided 95% confidence interval was calculated.|Screening, at 8-week intervals thereafter (on Day 1 of every odd-numbered cycle) through 15 cycles and every 3 cycles thereafter until disease progression or up to data cut-off date: 29 Feb 2016 (approximately up to 20 months)|ITT Population included all participants who were randomized to each regimen regardless of whether they received study drug or adhered to the assigned dose.||percentage of participants||95% Confidence Interval|Number
659068|NCT01888900|Secondary|End of Treatment Responder|end of treatment response (HCV RNA <LLOQ Target not Detected at week24)|Week 24 post treatment|||Participants|||Count of Participants
648904|NCT02094573|Primary|Confirmed Objective Response Rate (ORR) as Assessed by Investigator|ORR assessed by the investigator, is defined as proportion of the participants with confirmed Complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid tumors (RECIST) v1.1 (confirmed ≥4 weeks after initial response), after initiation of study treatment. CR for target lesion: disappearance of all extranodal lesions and all pathological lymph nodes must have decreased to <10 mm in short axis. CR for non-target lesion: Disappearance of all extranodal non-target lesions, all lymph nodes must be non-pathological in size (<10mm short axis) and norrmalization of tumor marker level. PR: at least 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline sum diameters. The exact 2-sided 97.5% confidence interval was calculated. The treatment regimen was considered to have achieved the primary objective when lower bound of the 97.5% confidence interval for ORR assessed by investigator is greater than 20%.|Screening, at 8-week intervals thereafter (on Day 1 of every odd-numbered cycle) through 15 cycles and every 3 cycles thereafter until disease progression or up to data cut-off date: 29 Feb 2016 (approximately up to 20 months)|Intention to Treat (ITT) Population included all participants who were randomized to each regimen regardless of whether they received study drug or adhered to the assigned dose.||percentage of participants||97.5% Confidence Interval|Number
648905|NCT02094534|Secondary|Mean Nighttime, Daytime, and Fasting Glucose Levels|Mean glucose levels (by continuous glucose monitoring (CGM)) in Type 1 diabetes patients treated with ORMD-0801, compared to the mean glucose levels (by continuous glucose monitoring) for patients treated with placebo.|last two days (day 6 and day 7, averaged)|Intent to treat (ITT) population; This measurement is reported for those subjects who had at least 80% of the CGM readings. This explains why there are two fewer subjects from the ITT population reported for this endpoint.||mg/dL||Standard Deviation|Mean
648906|NCT02094534|Primary|Change From Baseline in Total, Basal, and Bolus Exogenous Insulin Requirements|Change from baseline (Run-in Average) to treatment days 6 and 7 (average of day 6 and 7) in exogenous insulin requirements in patients treated with ORMD-0801 compared to patients treated with placebo.|Baseline:Run-In Average (run in days 1-7), and treatment (day 6 and day 7)|Intend-to-treat polpulation||mg/dL||Standard Deviation|Mean
648907|NCT02094443|Secondary|Percentage of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Had Normalized ALT at Treatment End and Study End|ALT is an enzyme found mostly in the cells of the liver and kidney. When the liver is damaged, ALT is released into the blood. This makes ALT a common test for liver damage, because higher ALT levels may indicate more liver damage. ALT upper limit of normal is commonly considered to be 40 international units per liter (IU/L), so abnormal ALT is above 40 IU/L.|Up to 24 weeks|Full Analysis Set||percentage of participants|||Number
648908|NCT02094443|Secondary|Percentage of Participants With End of Treatment Response (ETR)|ETR was defined as serum HCV RNA < LLOQ at treatment end (completed or prematurely discontinued).|Up to 24 weeks|Full Analysis Set||percentage of participants|||Number
648909|NCT02094443|Secondary|Percentage of Participants With Rapid Virologic Response (RVR)|eRVR was defined as serum HCV RNA < LLOQ after 4 weeks of treatment|4 weeks|Full Analysis Set||percentage of participants|||Number
648910|NCT02094443|Secondary|Percentage of Participants With Extended Rapid Virologic Response|Extended rapid virologic response (eRVR) was defined as serum HCV RNA < LLOQ after 2 weeks of treatment|2 weeks|Full Analysis Set||percentage of participants|||Number
648911|NCT02094443|Secondary|Percentage of Participants Achieving Sustained Virologic Response (SVR) 4, 12, and 24 Weeks After Treatment|SVR is defined as HCV RNA less than the lower limit of quantification (LLOQ), i.e., <15 IU/mL, at 4 weeks (SVR4), 12 weeks (SVR12), and 24 weeks (SVR24) after treatment, respectively.|Up to 24 weeks posttreatment|Full Analysis Set||percentage of participants|||Number
648912|NCT02094443|Primary|Change From Baseline in Alanine Aminotransferase (ALT) at Week 12|ALT levels were assessed as part of clinical chemistry assessments throughout the study as a measure of biochemical liver recovery. A negative change from baseline indicates less liver damage.|Baseline, Week 12|Participants in the safety set with available data at the given time point||U/L||Standard Deviation|Mean
648913|NCT02094443|Primary|Change From Baseline in Hepatitis C Virus Ribonucleic Acid Viral Load at Week 12|The change in log transformed Hepatitis-C Virus (HCV) Ribonucleic acid (RNA) from baseline to Week 12.|Baseline, Week 12|Full Analysis Set||log10 IU/mL||Standard Deviation|Mean
648914|NCT02094352|Secondary|Safety|Verify the safety of dosing as defined in the protocol (e.g., adverse events, complications).|6 months post infusion||||||
648915|NCT02094352|Secondary|Improved Pain-related Quality of Life and Mental Status|Compare pain-related quality of life and mental status data (including MMSE, SF-26v2, ORSDS, HADS, RASQ, WAQ, AROM, and threshold for touch) over six months.|6 months post infusion||||||
648916|NCT02094352|Primary|Pain Reduction|Evidence of changes in NRS pain scores between baseline and six months post infusion|6 months post infusion|Study terminated early due to lack of enrollment. We did not measure or analyze any data.|||||
648917|NCT02094326|Secondary|Exposure Time of Methotrexate|methotrexate|6 years|||months||Standard Deviation|Mean
648918|NCT02094326|Secondary|Percentage of Patients Who Receive Subcutaneous Methotrexate||6 years|||percentage of participants||95% Confidence Interval|Number
648919|NCT02094326|Secondary|Percentage of Patients Who Require an Alternative DMARD Due to Lack of Efficacy, Defined as Primary or Secondary Failure According to the Rheumatologist In-charge of Treatment||6 years|||percentage of participants||95% Confidence Interval|Number
648920|NCT02094326|Secondary|Percentage of Patients Who Experience Adverse Events While on Treatment With Synthetic DMARDs Which Forces Drug Withdrawal||6 years|||percentage of participants||95% Confidence Interval|Number
648921|NCT02094326|Secondary|Percentage of Patients Who Present Adverse Events While on Treatment With Synthetic Disease-modifying Antirheumatic Drug (DMARDs) and Require a Dose Reduction of the Synthetic DMARD in Question||6 years|||percentage of participants||95% Confidence Interval|Number
648922|NCT02094326|Primary|Percentage of Patients Who Present Adverse Events, Intolerance or Lack of Efficacy to Synthetic DMARDs That Causes a Change in Treatment Prescription When Used in Routine Clinical Practice||6 years|||percentage of participants||95% Confidence Interval|Number
649109|NCT02091726|Secondary|Participant Fully Satisfied and Would Recommend to Friends and Family|Yes to both of the following questions: Are you fully satisfied with your circumcision result? Would you recommend circumcision to friends or family?|4 weeks|104 men came for their 4-week followup, but 1 man did not complete the satisfaction questions.||participants|||Number
648924|NCT02094261|Secondary|Progression-Free Survival (PFS)|Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Progressive Disease (PD): >= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of >=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. PFS is the time from date of first dose until the date of PD (by independent review) or death (by any cause in the absence of progression) regardless of whether the patient withdrew from AZD9291 therapy or received another anti-cancer therapy prior to progression. Patients who had not progressed or died at the time of analysis were censored at the time of the latest date of assessment from their last evaluable RECIST 1.1 assessment.|RECIST tumour assessments every 6 weeks from first dose until objective disease progression, up to approximately 11 months (at the time of analysis)|All patients who received at least 1 dose of study treatment.||months||95% Confidence Interval|Median
648925|NCT02094261|Secondary|Disease Control Rate (DCR)|Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions; Stable disease (SD): Neither sufficient shrinkage to qualify as a response nor sufficient growth to qualify as progression; Progressive Disease (PD): >= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of >=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. DCR is the percentage of patients with best response of CR, PR or SD (according to independent review), prior to progression (PD) or further anti-cancer therapy.|RECIST tumour assessments every 6 weeks from first dose until objective disease progression, up to approximately 11 months (at the time of analysis)|All patients who received at least 1 dose of study treatment and had measurable disease at baseline according to the independent review of baseline imaging data.||% of participants||95% Confidence Interval|Number
648926|NCT02094261|Secondary|Duration of Response (DoR)|Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. DoR was defined as the time from the date of first documented response (CR or PR that was subsequently confirmed) until the date of documented progression (PD) or death in the absence of disease progression (by investigator assessment).|RECIST tumour assessments every 6 weeks from first dose until objective disease progression, up to approximately 11 months (at the time of analysis)|All patients who received at least 1 dose of study treatment, had measurable disease at baseline according to the independent review of baseline imaging data and had confirmed response.||months||Full Range|Median
648927|NCT02094261|Primary|Objective Response Rate (ORR)|Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. ORR is the percentage of patients with at least 1 visit response of CR or PR (according to independent review) that was confirmed at least 4 weeks later, prior to progression or further anti-cancer therapy.|RECIST tumour assessments every 6 weeks from first dose until objective disease progression, up to approximately 11 months (at the time of analysis)|All patients who received at least 1 dose of study treatment and had measurable disease at baseline according to the independent review of baseline imaging data.||% of participants||95% Confidence Interval|Number
648928|NCT02093962|Primary|Overall Survival|To assess the efficacy of pemetrexed in combination with TH-302 as determined by overall survival in patients with advanced non-squamous NSCLC in the second-line chemotherapy setting compared with pemetrexed in combination with placebo|2 years|||Participants|||Count of Participants
648929|NCT02093949|Secondary|Spontaneous AF at the Beginning of the Procedure|Spontaneous AF at the beginning of the procedure|baseline|||Participants|||Count of Participants
648930|NCT02093949|Secondary|Mean LA Volume|Left Atrial volume before ablation in ml|baseline|||ml||Standard Deviation|Mean
648931|NCT02093949|Secondary|Maximum Sustained AF Duration|duration of the longest AF epiodes in months before ablation|from first AF episode to baseline|||months|||Number
648932|NCT02093949|Secondary|Number of Patients With Major Adverse Events During and up to 18 Months After Procedure|Adverse events|18 months post ablation|||participants|||Number
648933|NCT02093949|Secondary|Percentage of Patients Free From Atrial Fibrillation 18 Months Post Ablation|% of patients in sinus rhythm or in atrial tachycardia assessed by ECG and/ot 24h-Holter monitoring and clinical examination during follow-up.|18 Months post ablation|||% of participants|||Number
648934|NCT02093949|Secondary|Radiofrequency Time (Min)||up to 300 min|||min|||Number
648935|NCT02093949|Secondary|% of Patients With Sinus Rhythm Conversion During the Procedure||180 min|||% of participants|||Number
648936|NCT02093949|Primary|Percentage of Patient With Atrial Fibrillation Termination at the End of the Procedure|percentage of patient in sinus rhythm or in atrial tachycardia at the end of the procedure|up to 240 min|||Percentage of participants|||Number
648937|NCT02093923|Other Pre-specified|HAE Attack Rate Per Week|The pre-specified, primary efficacy analysis was based on subjects in the 300 mg, 400 mg, and placebo dose groups with a historical baseline attack rate of at least 2 attacks over the last 3 months prior to enrollment. The result is based on General Estimating Equation (GEE) analysis of repeated counts per week during the prespecified assessment period (Days 8 to 50; predicted to correspond to a period of notable drug exposure). Baseline HAE attack rate per week is a covariate, treatment group is a fixed effect, and subject is a random effect in the GEE model with independence working correlation structure.|Baseline, Day 8 to Day 50|Only subjects who had a baseline attack rate of at least 2 attacks in the last 3 months prior to enrollment are included.||attacks/week||Standard Error|Mean
648938|NCT02093923|Secondary|Terminal Elimination Half-life (t1/2)||Pharmacokinetic samples were drawn on Days 1, 2, 4, 8, 15, 16, 18, 22, 29, 36, 50, 64, 92, and 120.|All randomized HAE subjects who received at least 1 dose of DX-2930 and who have sufficient blood samples for pharmacokinetic analyses. Results from placebo-treated subjects were not analyzed for summary statistics since these subjects did not have detectable drug levels.||days||Standard Deviation|Mean
649110|NCT02091726|Secondary|Cosmetic Result Excellent|Excellent: scar line straight without any irregularity Irregular: Some irregularity to scar line Scalloped: wavy appearane to scar line|4 weeks|104 men came for their 4-week followup but the doctor(s) failed to note the cosmetic result in 2 men.||participants|||Number
648941|NCT02093923|Secondary|Area Under the Plasma Concentration-time Curve (AUC)||Pharmacokinetic samples were drawn on Days 1, 2, 4, 8, 15, 16, 18, 22, 29, 36, 50, 64, 92, and 120.|All randomized HAE subjects who received at least 1 dose of DX-2930 and who have sufficient blood samples for pharmacokinetic analyses. Results from placebo-treated subjects were not analyzed for summary statistics since these subjects did not have detectable drug levels.||day*ng/mL||Standard Deviation|Mean
648942|NCT02093923|Secondary|Time to Maximum Plasma Concentration (Tmax)||Pharmacokinetic samples were drawn on Days 1, 2, 4, 8, 15, 16, 18, 22, 29, 36, 50, 64, 92, and 120.|All randomized HAE subjects who received at least 1 dose of DX-2930 and who have sufficient blood samples for pharmacokinetic analyses. Results from placebo-treated subjects were not analyzed for summary statistics since these subjects did not have detectable drug levels.||days||Standard Deviation|Mean
648943|NCT02093923|Secondary|Maximum Plasma Concentration (Cmax)||Pharmacokinetic samples were drawn on Days 1, 2, 4, 8, 15, 16, 18, 22, 29, 36, 50, 64, 92, and 120.|All randomized HAE subjects who received at least 1 dose of DX-2930 and who have sufficient blood samples for pharmacokinetic analyses. Results from placebo-treated subjects were not analyzed for summary statistics since these subjects did not have detectable drug levels.||ng/mL||Standard Deviation|Mean
648944|NCT02093923|Primary|Proportion of Patients With Serious Adverse Events|"As per the DX-2930-02 clinical protocol, a SAE was any adverse experience occurring at any dose that resulted in any of the following outcomes:
Death
Life-threatening experience: “life-threatening” referred to a situation in which the subject was at risk of death at the time of the event, it did not refer to an event that might have caused death if it were more severe.
Required inpatient hospitalization or prolongation of existing hospitalization: this did not include hospitalization for observation with release within 24 hours. A scheduled hospitalization for a pre-existing condition that had not worsened during participation in the study did not meet this criterion. Pre-planned hospitalizations for an elective medical/surgical procedure or routine check-ups did not meet this criterion.
Resulted in persistent or significant disability or incapacity.
Was a congenital anomaly or birth defect.
Was considered to be an important medical event"|through 4 months|All randomized subjects who received at least 1 dose of study drug. The outcome measure data is presented as proportion (percentage) of participants with serious adverse events.||percentage of participants|||Number
648945|NCT02093923|Primary|Number of Patients With Serious Adverse Events (SAEs)|"As per the DX-2930-02 clinical protocol, a SAE was any adverse experience occurring at any dose that resulted in any of the following outcomes:
Death
Life-threatening experience: “life-threatening” referred to a situation in which the subject was at risk of death at the time of the event, it did not refer to an event that might have caused death if it were more severe.
Required inpatient hospitalization or prolongation of existing hospitalization: this did not include hospitalization for observation with release within 24 hours. A scheduled hospitalization for a pre-existing condition that had not worsened during participation in the study did not meet this criterion. Pre-planned hospitalizations for an elective medical/surgical procedure or routine check-ups did not meet this criterion.
Resulted in persistent or significant disability or incapacity.
Was a congenital anomaly or birth defect.
Was considered to be an important medical event"|through 4 months|All randomized subjects who received at least 1 dose of study drug. The outcome measure data is presented as number of participants with serious adverse events||participants|||Number
648946|NCT02093923|Primary|Proportion of Patients With Treatment-Emergent Adverse Events (TEAE)|As per the DX-2930-02 clinical protocol, an AE was considered treatment-emergent if the onset time was after administration of study drug through the Day 120 post-dose final follow-up visit or, in the event that onset time preceded study drug administration, the AE increased in severity during the 120-day post-dose follow-up period.|through 4 months|All randomized subjects who received at least 1 dose of study drug. The outcome measure data is presented as proportion (percentage) of participants with Treatment-Emergent Adverse Events (TEAE)||percentage of participants|||Number
648947|NCT02093923|Primary|Number of Patients With Treatment-Emergent Adverse Events (TEAE)|As per the DX-2930-02 clinical protocol, an AE was considered treatment-emergent if the onset time was after administration of study drug through the Day 120 post-dose final follow-up visit or, in the event that onset time preceded study drug administration, the AE increased in severity during the 120-day post-dose follow-up period.|through 4 months|All randomized subjects who received at least 1 dose of study drug. The outcome measure data is presented as number of participants with Treatment-Emergent Adverse Events (TEAE).||participants|||Number
648948|NCT02093897|Secondary|Number of Subjects With Inhibitor Formation to rVIII-SingleChain|The number of subjects who develop inhibitors to rVIII-SingleChain, defined as a rVIII-SingleChain antibody titer of at least 0.6 Bethesda Units (BU) per mL after receiving study drug.|At screening, then after dosing at approximately monthly intervals for 6 months, then every 3 months until reaching 50 EDs, and at the end of study visit (up to approximately 12 months).|||participants|||Number
648949|NCT02093897|Secondary|Clearance (Cl) of rVIII-SingleChain|Clearance (Cl) of rVIII-SingleChain, baseline uncorrected; plasma FVIII activity measured using the chromogenic substrate assay.|Immediately before dosing, and at approximately 1, 5, 10, 24, and 48 hours after dosing.|PK Population||mL/h/kg||Standard Deviation|Mean
648950|NCT02093897|Secondary|Area Under the Concentration Curve (AUC)|AUC to the last sample with quantifiable drug concentration (AUC0–t), baseline uncorrected; plasma FVIII activity measured using the chromogenic substrate assay.|Immediately before dosing, and at approximately 1, 5, 10, 24, and 48 hours after dosing.|PK Population||IU*h/dL||Standard Deviation|Mean
648951|NCT02093897|Secondary|Half-life (t1/2) of rVIII-SingleChain|Half-life (t1/2) of rVIII-SingleChain, baseline uncorrected; plasma FVIII activity measured using the chromogenic substrate assay.|Immediately before dosing, and at approximately 1, 5, 10, 24, and 48 hours after dosing.|PK Population||hour||Standard Deviation|Mean
648952|NCT02093897|Secondary|Incremental Recovery|Incremental recovery expressed as (IU/dL)/(IU/kg) corrected for subject's predose plasma FVIII activity measured using the chromogenic substrate assay.|At 1 hour after the start of infusion|PK Population||(IU/dL)/(IU/kg)||Standard Deviation|Mean
648953|NCT02093897|Secondary|Consumption of rVIII-SingleChain (On-demand Regimen) - Number of Infusions Per Subject Per Year||Up to 1 year|Subjects assigned to the on-demand treatment regimen.||number of infusions per subject per year||Full Range|Median
648954|NCT02093897|Secondary|Consumption of rVIII-SingleChain (On-demand Regimen) - Number of Infusions Per Subject Per Month||Up to 1 year|Subjects assigned to the on-demand treatment regimen.||number of infusion per subject per month||Full Range|Median
648955|NCT02093897|Secondary|Consumption of rVIII-SingleChain - IU/kg Per Bleeding Event||Up to 1 year|The Efficacy Population comprised all subjects who received at least 1 rVIII-SingleChain dose for prophylaxis or on-demand treatment. One subject was excluded from the efficacy population because of a pre-existing inhibitor to FVIII (confirmed by reexamination of a screening sample initially reported as negative due to laboratory error).||IU/kg per event||Full Range|Median
648956|NCT02093897|Secondary|Consumption of rVIII-SingleChain - IU/kg Per Subject Per Year||Up to 1 year|The Efficacy Population comprised all subjects who received at least 1 rVIII-SingleChain dose for prophylaxis or on-demand treatment. One subject was excluded from the efficacy population because of a pre-existing inhibitor to FVIII (confirmed by reexamination of a screening sample initially reported as negative due to laboratory error).||IU/kg per subject per year||Full Range|Median
648957|NCT02093897|Secondary|Consumption of rVIII-SingleChain - IU/kg Per Subject Per Month||Up to 1 year|The Efficacy Population comprised all subjects who received at least 1 rVIII-SingleChain dose for prophylaxis or on-demand treatment. One subject was excluded from the efficacy population because of a pre-existing inhibitor to FVIII (confirmed by reexamination of a screening sample initially reported as negative due to laboratory error).||IU/kg per subject per month||Full Range|Median
648958|NCT02093897|Secondary|Percentage of Bleeding Episodes Requiring 1, 2, 3, or More Than 3 Infusions of rVIII-SingleChain to Achieve Hemostasis.||Up to 1 year|Efficacy Population||Percentage (%) of bleeding episodes|Number of Treated Bleeds||Number
648959|NCT02093897|Secondary|Annualized Bleeding Rate|The annualized bleeding rate was defined as the number of bleeding episodes requiring treatment divided by the efficacy evaluation period in days, x 365.25, and is presented separately for the on-demand regimen and the prophylaxis regimens.|Up to 1 year|The Efficacy Population comprised all subjects who received at least 1 rVIII-SingleChain dose for prophylaxis or on-demand treatment. One subject was excluded from the efficacy population because of a pre-existing inhibitor to FVIII (confirmed by reexamination of a screening sample initially reported as negative due to laboratory error).||Treated bleeding episodes per year||Inter-Quartile Range|Median
648960|NCT02093897|Primary|Treatment Success|"Rate of treatment success where treatment success of a bleeding episode is defined as a rating of excellent or good based on the investigator's overall clinical assessment of hemostatic efficacy (using a 4-point scale of excellent, good, moderate or poor/no response) on the on-demand and prophylaxis regimens combined. The rate of success was based on the number of treated bleeding events; there were 347 treated bleeding events in the Efficacy Population."|Up to 1 year|Efficacy Population||Percentage of treated bleeding events|Treated bleeding events|95% Confidence Interval|Number
648961|NCT02093819|Secondary|AUC 0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity)|AUC 0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)|2 hour (h) before drug administration and 15minutes (min), 30min, 45min, 1h,1h 30min, 1h 45min, 2h, 3h, 4h, 4h 15min, 6h, 7h, 8h, 10h, 12h, 24h, 34h and 48h after drug administration|The PKS included 59 subjects of the TS who provided at least 1 value of the endpoints Cmax, AUC0-∞, or AUC0-tz.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
648962|NCT02093819|Secondary|Cmax (Maximum Measured Concentration of the Analyte in Plasma)|Cmax (maximum measured concentration of the analyte in plasma)|2 hour (h) before drug administration and 15minutes (min), 30min, 45min, 1h,1h 30min, 1h 45min, 2h, 3h, 4h, 4h 15min, 6h, 7h, 8h, 10h, 12h, 24h, 34h and 48h after drug administration|The PKS included 59 subjects of the TS who provided at least 1 value of the endpoints Cmax, AUC0-∞, or AUC0-tz.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
648963|NCT02093819|Primary|Percentage of Subjects With Drug-related Adverse Events|Percentage of subjects with drug-related adverse events|AEs were recorded throughout the trial|The PKS included 59 subjects of the TS who provided at least 1 value of the endpoints Cmax, AUC0-∞, or AUC0-tz.||percentage of participants|||Number
648964|NCT02093702|Secondary|Mean Change in Adherence to the Canadian Diabetes Association's Clinical Practice Guidelines Resistance Exercise Recommendations|The Canadian Diabetes Association's Clinical Practice Guidelines recommends at least 2 sessions per week of resistance exercise.|Baseline and 12 months|||sessions/week||Full Range|Mean
648965|NCT02093702|Secondary|Mean Change in Adherence to the Canadian Diabetes Association's Clinical Practice Guidelines Aerobic Exercise Recommendations|The Canadian Diabetes Association's Clinical Practice Guidelines recommends at least 150 minutes per week of aerobic exercise.|Baseline and 12 months|||minutes/week||Full Range|Mean
648966|NCT02093702|Primary|Mean Change in Diastolic Blood Pressure||Baseline and 12 months|||mm Hg||Full Range|Mean
648967|NCT02093702|Primary|Mean Change in Total Cholesterol: HDL-C Ratio||Baseline and 12 months|||mmol/L:mmol/L||Full Range|Mean
648968|NCT02093702|Primary|Mean Change in Triglycerides (TGs)||Baseline and 12 months|||mmol/L||Full Range|Mean
648969|NCT02093702|Primary|Mean Change in LDL-C||Baseline and 12 months|||mmol/L||Full Range|Mean
648970|NCT02093702|Primary|Mean Change in HDL-C||Baseline and 12 months|||mmol/L||Full Range|Mean
648971|NCT02093702|Primary|Mean Change in Serum Total Cholesterol||Baseline and 12 months|||mmol/L||Full Range|Mean
648972|NCT02093702|Primary|Mean Change in Body Mass Index||Baseline and 12 months|||kg/m^2||Full Range|Mean
648973|NCT02093702|Primary|Mean Change in Waist Circumference||Baseline and 12 months|||cm||Full Range|Mean
648974|NCT02093702|Primary|Mean Change in Systolic Blood Pressure||Baseline and 12 months|||mm Hg||Full Range|Mean
648975|NCT02093702|Primary|Mean Change in Hemoglobin A1c (HbA1c) Levels||Baseline and 12 months|||mmol/mol||Full Range|Mean
648976|NCT02093520|Secondary|Number of Participants Who Achieved a Clinically Significant Improvement in the Zurich Claudication Questionnaire (ZCQ) at 12 Months|Proportion of ZCQ Responders from baseline to one year follow-up in each of the two treatment groups using validated Minimal Important Change value as the clinically significant efficacy threshold.|12 months|Six participants in the MILD and 22 in the ESI group did not receive study treatment, therefore 143/149 MILD participants and 129/153 ESI participants were analyzed for outcome.||Participants|||Count of Participants
649111|NCT02091726|Secondary|Wound Separation|Wound separation caused by adhesive failure (minor --requires no treatment)|4 weeks|Wound dehiscence < 2 cm. None required treatment. There were no participants with wound dehiscence > 2 cm.||participants|||Number
649112|NCT02091726|Secondary|Completely Healed at 4 Weeks|Definition: Completely epithelialized; no superficial ulcerations or granulation tissue present|4 weeks|||participants|||Number
648977|NCT02093520|Secondary|Number of Participants Who Acheived a Clinical Significant Improvement in the Numeric Pain Rating Scale (NPRS) at 12 Months|Proportion of NPRS Responders from baseline to one year follow-up in each of the two treatment groups using validated Minimal Important Change value as the clinically significant efficacy threshold.|12 months|Six participants in the MILD and 22 in the ESI group did not receive study treatment, therefore 143/149 MILD participants and 129/153 ESI participants were analyzed for outcome.||Participants|||Count of Participants
648978|NCT02093520|Primary|Number of Participants Who Achieved a Clinically Significant Improvement in the Oswestry Disability Index at 12 Months|Proportion of ODI Responders from baseline to one year follow-up in the treatment group versus the proportion of ODI Responders from baseline to one year follow-up in the control group. ODI Responders are defined as those patients achieving the validated Minimal Important Change in ODI score from baseline to follow-up as a clinically significant efficacy threshold.|12 months|Six participants in the MILD and 22 in the ESI group did not receive study treatment, therefore 143/149 MILD participants and 129/153 ESI participants were analyzed for outcome.||Participants|||Count of Participants
648979|NCT02093390|Secondary|Plasma Trough Concentrations for Atorvastatin|Blood samples for atorvastatin trough levels were collected predose (before dosing with atorvastatin and before breakfast) on Days 8 through 12.|Days 8 to 12 Predose|PK-Evaluable population included all enrolled participants who received at least one dose of study drug and had data available for analysis of the PK parameters.||ng/mL||Standard Deviation|Mean
648980|NCT02093390|Secondary|Plasma Trough Concentrations for Fluconazole|Blood samples for fluconazole trough levels were collected predose (before dosing with fluconazole and before breakfast) on Days 8 through 12.|Days 8 to 12 Predose|PK-Evaluable population included all enrolled participants who received at least one dose of study drug and had data available for analysis of the PK parameters.||ng/mL||Standard Deviation|Mean
648981|NCT02093390|Secondary|Fraction Excreted Unchanged (Fe) of TAK-385|Fraction of TAK-385 excreted in the urine unchanged.|Days 1 and 10 (Predose and multiple time points up to 120 hours postdose)|PK-Evaluable population included all enrolled participants who received at least one dose of study drug and had data available for analysis of the PK parameters.||percent of TAK-385||Standard Deviation|Mean
648982|NCT02093390|Secondary|Apparent Total Body Clearance (CL/F) of TAK-385||Days 1 and 10 (Predose and multiple time points up to 120 hours postdose)|PK-Evaluable population included all enrolled participants who received at least one dose of study drug and had data available for analysis of the PK parameters.||liters/hour||Standard Deviation|Mean
648983|NCT02093390|Secondary|Terminal Disposition Half-life (t1/2) of TAK-385|Terminal disposition half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.|Days 1 and 10 (Predose and multiple time points up to 120 hours postdose)|PK-Evaluable population included all enrolled participants who received at least one dose of study drug and had data available for analysis of the PK parameters.||hours||Standard Deviation|Mean
648984|NCT02093390|Secondary|AUC (0-120): Area Under the Plasma Concentration-Time Curve From Time 0 to 120 Hours of TAK-385|Area under the plasma concentration versus time curve from 0 to 120 hours after study drug administration.|Days 1 and 10 (Predose and multiple time points up to 120 hours postdose)|PK-Evaluable population included all enrolled participants who received at least one dose of study drug and had data available for analysis of the PK parameters.||ng*hr/mL||Standard Deviation|Mean
648985|NCT02093390|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration of TAK-385|Tmax is the time to reach the maximum concentrations (Cmax), equal to time (hours) to Cmax.|Days 1 and 10 (Predose and multiple time points up to 120 hours postdose)|PK-Evaluable population included all enrolled participants who received at least one dose of study drug and had data available for analysis of the PK parameters.||hours||Full Range|Median
648986|NCT02093390|Secondary|Number of Participants With Clinical Significant Changes in Laboratory Tests|Blood samples were collected for analysis of clinical chemistry and hematological parameters and urine samples were obtained for urinalysis. Clinical laboratory evaluations were performed at central and /local laboratories.|Baseline and First dose of study drug through the end of the study (22 days ± 3 days)|Safety population included all randomized participants with at least one dose of study drug.||participants|||Number
648987|NCT02093390|Secondary|Number of Participants With Clinical Significant Changes in Electrocardiogram (ECG) Findings|A 12-lead ECG was administered on Days 1,9,10,11,15.|Baseline and First dose of study drug through Day 15|||participants|||Number
648988|NCT02093390|Secondary|Number of Participants With Clinical Significant Changes in Vital Signs|Vital sign measurements included oral temperature, heart rate, supine (after 3 to 5 minutes in this position) and standing (after 3 to 5 minutes in this position) measurements of diastolic and systolic blood pressure.|Baseline and First dose of study drug through the end of the study (22 days ± 3 days)|Safety population included all randomized participants with at least one dose of study drug.||participants|||Number
648989|NCT02093390|Secondary|Number of Participants With at Least 1 Treatment Emergent Adverse Event (AE)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|First dose of study drug through the end of the study (22 days ± 3 days)|Safety population included all randomized participants with at least one dose of study drug.||participants|||Number
648990|NCT02093390|Primary|AUC(0-inf): Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of TAK-385 on Day 10|Area under the plasma concentration-time curve from time 0 to infinity.|Day 10 (Predose and multiple time points up to 120 hours postdose)|PK-Evaluable population included all enrolled participants who received at least one dose of study drug and had data available for analysis of the PK parameters.||ng*hr/mL||Standard Deviation|Mean
648991|NCT02093390|Primary|AUC(0-inf): Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of TAK-385 on Day 1|Area under the plasma concentration-time curve from time 0 to infinity.|Day 1 (Predose and multiple time points up to 120 hours postdose)|PK-Evaluable population included all enrolled participants who received at least one dose of study drug and had data available for analysis of the PK parameters.||ng*hr/mL||Standard Deviation|Mean
649113|NCT02091726|Primary|Time for Procedure|Intraoperative time, total|1 hour|||Min||Inter-Quartile Range|Median
648992|NCT02093390|Primary|AUC(0-tlast): Area Under the Plasma Concentration Curve From Time Zero to the Time of the Last Quantifiable Concentration of TAK-385 on Day 10|Area under the plasma concentration versus time curve from zero to the time of the last quantifiable concentration.|Day 10 (Predose and multiple time points up to 120 hours postdose)|PK-Evaluable population included all enrolled participants who received at least one dose of study drug and had data available for analysis of the PK parameters.||ng*hr/mL||Standard Deviation|Mean
648993|NCT02093390|Primary|AUC(0-tlast): Area Under the Plasma Concentration Curve From Time Zero to the Time of the Last Quantifiable Concentration of TAK-385 on Day 1|Area under the plasma concentration versus time curve from zero to the time of the last quantifiable concentration.|Day 1 (Predose and multiple time points up to 120 hours postdose)|PK-Evaluable population included all enrolled participants who received at least one dose of study drug and had data available for analysis of the PK parameters.||ng*hr/mL||Standard Deviation|Mean
648994|NCT02093390|Primary|Cmax: Maximum Observed Plasma Concentration of TAK-385 on Day 10|Cmax is the peak concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Day 10 (Predose and multiple time points up to 120 hours postdose)|PK-Evaluable population included all enrolled participants who received at least one dose of study drug and had data available for analysis of the PK parameters.||ng/mL||Standard Deviation|Mean
648995|NCT02093390|Primary|Cmax: Maximum Observed Plasma Concentration of TAK-385 on Day 1|Cmax is the peak concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Day 1 (Predose and multiple time points up to 120 hours postdose)|Pharmacokinetic (PK)-Evaluable population included all enrolled participants who received at least one dose of study drug and had data available for analysis of the PK parameters.||ng/mL||Standard Deviation|Mean
648996|NCT02093351|Primary|Effect of Letrozole on Exposure to Olaparib - AUC0-τ|Olaparib AUC0-τ, in the presence and absence of co-administered letrozole, and associated AUC0-τ treatment ratios|Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours post morning dose on Day 5 and Day 43|The PK Analysis set included all patients who received a study drug dose and provided evaluable PK profiles for at least 1 treatment period in Part A.||mcg*h/mL||Geometric Coefficient of Variation|Geometric Mean
648997|NCT02093351|Primary|Effect of Olaparib on Exposure to Letrozole - AUC0-τ|Letrozole AUC0-τ, in the presence and absence of co-administered olaparib, and associated AUC0-τ treatment ratios|Pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 38 and Day 43|The PK Analysis set included all patients who received a study drug dose and provided evaluable PK profiles for at least 1 treatment period in Part A.||mcg*h/mL||Geometric Coefficient of Variation|Geometric Mean
648998|NCT02093351|Primary|Effect of Anastrozole on Exposure to Olaparib - AUC0-τ|Olaparib AUC0-τ, in the presence and absence of co-administered anastrozole, and associated AUC0-τ treatment ratios|Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours post morning dose on Day 5 and Day 24|The PK Analysis set included all patients who received a study drug dose and provided evaluable PK profiles for at least 1 treatment period in Part A.||mcg*h/mL||Geometric Coefficient of Variation|Geometric Mean
648999|NCT02093351|Primary|Effect of Olaparib on Exposure to Anastrozole - AUC0-τ|Anastrozole Area under plasma concentration-time curve over the dosing interval at steady state (AUC0-τ), in the presence and absence of co-administered olaparib, and associated AUC0-τ treatment ratios|Pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 19 and Day 24|The PK Analysis set included all patients who received a study drug dose and provided evaluable PK profiles for at least 1 treatment period in Part A.||mcg*h/mL||Geometric Coefficient of Variation|Geometric Mean
649000|NCT02093351|Primary|Effect of Tamoxifen on Exposure to Olaparib - AUC0-τ|Olaparib AUC0-τ, in the presence and absence of co-administered tamoxifen, and associated AUC0-τ treatment ratios|Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours post morning dose on Day 5 and Day 31|The PK Analysis set included all patients who received a study drug dose and provided evaluable PK profiles for at least 1 treatment period in Part A.||mcg*h/mL||Geometric Coefficient of Variation|Geometric Mean
649001|NCT02093351|Primary|Effect of Olaparib on Exposure to Tamoxifen - AUC0-τ|Tamoxifen, N-DMT and endoxifen AUC0-τ, in the presence and absence of co-administered olaparib, and associated AUC0-τ treatment ratios|Pre-dose and at 1, 2, 4, 5, 6, 8, 12 and 24 hours post-dose on Day 26 and Day 31|The PK Analysis set included all patients who received a study drug dose and provided evaluable PK profiles for at least 1 treatment period in Part A.||microgram x hour/millilitre (mcg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
649002|NCT02093351|Primary|Effect of Letrozole on Exposure to Olaparib - Cmax ss|Olaparib Cmax ss in the presence and absence of co-administered letrozole, and associated Cmax ss treatment ratios|Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours post morning dose on Day 5 and Day 43|The PK Analysis set included all patients who received a study drug dose and provided evaluable PK profiles for at least 1 treatment period in Part A.||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
649003|NCT02093351|Primary|Effect of Olaparib on Exposure to Letrozole - Cmax ss|Letrozole Cmax ss in the presence and absence of co-administered olaparib, and associated Cmax ss treatment ratios|Pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 38 and Day 43|PK Analysis set included all patients who received a study drug dose and provided evaluable PK profiles for at least 1 treatment period in Part A.||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
649004|NCT02093351|Primary|Effect of Anastrozole on Exposure to Olaparib - Cmax ss|Olaparib Cmax ss in the presence and absence of co-administered anastrozole, and associated Cmax ss treatment ratios|Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours post morning dose on Day 5 and Day 24|PK Analysis set included all patients who received a study drug dose and provided evaluable PK profiles for at least 1 treatment period in Part A.||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
649005|NCT02093351|Primary|Effect of Olaparib on Exposure to Anastrozole - Cmax ss|Anastrozole maximum plasma concentration at steady state (Cmax ss) in the presence and absence of co-administered olaparib, and associated Cmax ss treatment ratios|Pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 19 and Day 24|PK Analysis set included all patients who received a study drug dose and provided evaluable PK profiles for at least 1 treatment period in Part A.||micrograms per millilitre (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
649209|NCT02087059|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability||24 weeks|||Participants|||Number
653966|NCT01972776|Primary|Change From Baseline in Transition Dyspnea Index (TDI) (Part 2)||Baseline, 8 weeks|Part 2 was terminated early. Therefore, primary and secondary outcomes for part 2 were not assessed.|||||
649006|NCT02093351|Primary|Effect of Tamoxifen on Exposure to Olaparib - Cmax ss|Olaparib Cmax ss in the presence and absence of co-administered tamoxifen, and associated Cmax ss treatment ratios|Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours post morning dose on Day 5 and Day 31|The PK Analysis set included all patients who received a study drug dose and provided evaluable PK profiles for at least 1 treatment period in Part A.||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
649007|NCT02093351|Primary|Effect of Olaparib on Exposure to Tamoxifen - Cmax ss|Tamoxifen, N-desmethyl tamoxifen (N-DMT) and endoxifen Cmax ss in the presence and absence of co-administered olaparib, and associated Cmax ss treatment ratios|Pre-dose and at 1, 2, 4, 5, 6, 8, 12 and 24 hours post-dose on Day 26 and Day 31|The PK Analysis set included all patients who received a study drug dose and provided evaluable PK profiles for at least 1 treatment period in Part A.||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
649008|NCT02093234|Secondary|Change in Medication Adherence|Medication adherence Improvement from baseline after 1 year as measured by the Morisky Medication Adherence Survey. Range 1-4 . 1= least adherent , 4= most adherent|baseline and 1 year|||units on a scale||Standard Deviation|Mean
649009|NCT02093234|Secondary|Change in Hemoglobin A1C|Change in HbA1c after 1 year from baseline|Baseline and 1 year|||Percentage of total hemoglobin||Standard Error|Mean
649010|NCT02093234|Secondary|Change in Distress From Baseline as Measured With Fisher Brief Diabetes Distress Screening Instrument|"Participants completed the Fisher Brief Diabetes Screening Instrument at baseline and after 1 year of intervention. The instrument consists of 4 questions regarding how participants feel about dealing with diabetes. They are answered using a scale that goes from 1-6, 1= not a bother and 6=very bothersome. Range 4-24.
Low distress < 12 : moderate / high distress > or = 12."|Baseline and 1 year|||units on a scale||Standard Error|Mean
649011|NCT02093234|Primary|Change From Baseline in the Unmet Behaviors/Goals That Were Not Achieved at Year 1|The study staff will determine the status of the 13 behaviors/goals for the year prior to study enrollment. Our primary endpoint will be the mean change after 1 year in number of behaviors/goals met from baseline.|baseline and 1 year|Sample size estimates were based on the study hypotheses and the associated primary endpoint. Dropouts were analyzed using intention to treat methodology.||incomplete behaviors/goals||Standard Error|Mean
649012|NCT02093026|Secondary|Time Since Last Treatment Course|Time since last treatment course = The last day of the last dose of rituximab to date of last contact. Date of last contact is the last available date of efficacy, complete medication start date, laboratory, adverse event assessments, early withdrawal visit, date of last contact, or date of death.|Baseline up to 10 years|ITT Population. Here, number of participants analyzed = participants who entered into safety follow-up.||years||Standard Deviation|Mean
649013|NCT02093026|Secondary|Percentage of Participants Who Discontinued Treatment Due to Insufficient Response||First, second, third, fourth, fifth, sixth, and seventh course of rituximab (up to a median of approximately 2, 62, 124, 186, 248, 310, and 372 weeks, respectively)|Safety Population. Number analyzed = participants who were evaluable for specified category.||percentage of participants|||Number
649014|NCT02093026|Secondary|Change From Baseline in Total Rheumatoid Factors (RF) at 24 Weeks Following Each Course||24 weeks after first, second, third, fourth, fifth, sixth, and seventh course of rituximab (median duration of 26, 90.9, 162.9, 232, 297.3, 354.4, and 406.7 weeks, respectively)|The data for this outcome measure was not analyzed as this outcome was removed per changes in the planned analysis. Per changes in the planned analysis, only key efficacy parameters were analyzed as the long-term efficacy of rituximab is well established.|||||
649015|NCT02093026|Secondary|Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at 24 Weeks Following Each Course|The HAQ-DI is a questionnaire specific for rheumatoid arthritis and consists of 20 questions referring to 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Participants completed the questionnaire by answering the 20 questions on a scale of 0 (without difficulty) to 3 (unable to do). The total score ranges from 0 (no disability) to 3 (completely disabled). A negative change score indicates improvement.|24 weeks after first, second, third, fourth, fifth, sixth, and seventh course of rituximab (median duration of 26, 90.9, 162.9, 232, 297.3, 354.4, and 406.7 weeks, respectively)|ITT Population. Here, number of participants analyzed = participants who were evaluable for this outcome. Number analyzed = participants who were evaluable for specified category.||units on a scale||Standard Deviation|Mean
649016|NCT02093026|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Response of 'Good' or 'Moderate'|DAS28-ESR was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and Physician's Global Assessment of Disease Activity (VAS: 0=no disease activity to 100=maximum disease activity). DAS28-ESR = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014*Patient's Global Assessment of Disease Activity. The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders had a change from baseline greater than (>) 1.2 with a DAS28 score less than or equal to (≤) 3.2; moderate responders had a change from baseline >1.2 with a DAS28 score >3.2 to less than or equal to (≤) 5.1 or a change from baseline >0.6 to ≤1.2 with a DAS28 score ≤5.1.|24 weeks after first, second, third, fourth, fifth, sixth, and seventh course of rituximab (median duration of 26, 90.9, 162.9, 232, 297.3, 354.4, and 406.7 weeks, respectively)|ITT Population. Here, number of participants analyzed = participants who were evaluable for this outcome. Number analyzed = participants who were evaluable for specified category.||percentage of participants|||Number
649017|NCT02093026|Secondary|Percentage of Participants With Low Disease Activity and Clinical Remission Based on DAS28-ESR|DAS28-ESR was calculated from SJC and TJC using 28 joints count, ESR (millimeters per hour [mm/hour]), and Patient's Global Assessment of Disease Activity (VAS: 0=no disease activity to 100=maximum disease activity). DAS28-ESR = 0.56*square root (sqrt)(TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*Patient's Global Assessment of Disease Activity. Total score range: 0-10, higher score=more disease activity. DAS28-ESR <= 3.2 implied low disease activity (LDA) and DAS28-ESR <2.6 = clinical remission.|24 weeks after first, second, third, fourth, fifth, sixth, and seventh course of rituximab (median duration of 26, 90.9, 162.9, 232, 297.3, 354.4, and 406.7 weeks, respectively)|ITT Population. Here, number of participants analyzed = participants who were evaluable for this outcome. Number analyzed = participants who were evaluable for specified category.||percentage of participants|||Number
649018|NCT02093026|Secondary|American College of Rheumatology Index of Improvement (ACRn) Response|The ACRn is calculated for each participant by taking the lowest percentage improvement in (1) SJC or (2) TJC or (3) the median of the remaining 5 components of the ACR response (patient’s assessment of disease activity; patient’s global assessment of pain; physician's assessment of disease activity; participant's assessment of physical function; an acute phase reactant value [either CRP or ESR]). The index of improvement in RA, where 0 indicates no improvement and 100 indicates a 100% improvement across all signs and symptoms of RA. ACRn scores were calculated considering the original baseline in the precursor studies WA16291 or WA17043.|24 weeks after first, second, third, fourth, fifth, sixth, and seventh course of rituximab (median duration of 26, 90.9, 162.9, 232, 297.3, 354.4, and 406.7 weeks, respectively)|ITT Population. Here, number of participants analyzed = participants who were evaluable for this outcome. Number analyzed = participants who were evaluable for specified category.||units on a scale||Standard Deviation|Mean
649019|NCT02093026|Secondary|Percentage of Participants With ACR50 and ACR70 Response|A participant had an ACR50 and ACR70 response if there was at least a 50% or 70% improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of disease activity [VAS: 0=no disease activity to 100=maximum disease activity]; 2) Patient's Global Assessment of Disease Activity [VAS: 0=no disease activity to 100=maximum disease activity]; 3) Patient's Assessment of Pain [VAS: 0=no pain to 100=unbearable pain]; 4) Health Assessment Questionnaire [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do] and 5) an acute-phase reactant (CRP or ESR). The ACR50 and ACR70 responses were compared to Baseline in the precursor studies WA16291 or WA17043.|24 weeks after first, second, third, fourth, fifth, sixth, and seventh course of rituximab (median duration of 26, 90.9, 162.9, 232, 297.3, 354.4, and 406.7 weeks, respectively)|ITT Population. Here, number of participants analyzed = participants who were evaluable for this outcome. Number analyzed = participants who were evaluable for specified category.||percentage of participants|||Number
649020|NCT02093026|Primary|Percentage of Participants With ACR20 Response After Seventh Course|A participant had an ACR20 response if there was at least a 20% improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity [VAS: 0=no disease activity to 100=maximum disease activity]; 2) Patient's Global Assessment of Disease Activity [VAS: 0=no disease activity to 100=maximum disease activity]; 3) Patient's Assessment of Pain [VAS: 0=no pain to 100=unbearable pain]; 4) Health Assessment Questionnaire [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do] and 5) an acute-phase reactant (either CRP or ESR). The ACR20 response was compared to Baseline in the precursor studies WA16291 or WA17043.|24 weeks after seventh course of rituximab (median duration of 406.7 weeks)|ITT Population. Here, number of participants analyzed = participants who were evaluable for this outcome.||percentage of participants|||Number
649021|NCT02093026|Primary|Percentage of Participants With ACR20 Response After Sixth Course|A participant had an ACR20 response if there was at least a 20% improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity [VAS: 0=no disease activity to 100=maximum disease activity]; 2) Patient's Global Assessment of Disease Activity [VAS: 0=no disease activity to 100=maximum disease activity]; 3) Patient's Assessment of Pain [VAS: 0=no pain to 100=unbearable pain]; 4) Health Assessment Questionnaire [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do] and 5) an acute-phase reactant (either CRP or ESR). The ACR20 response was compared to Baseline in the precursor studies WA16291 or WA17043.|24 weeks after sixth course of rituximab (median duration of 354.4 weeks)|ITT Population. Here, number of participants analyzed = participants who were evaluable for this outcome.||percentage of participants|||Number
649022|NCT02093026|Primary|Percentage of Participants With ACR20 Response After Fifth Course|A participant had an ACR20 response if there was at least a 20% improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity [VAS: 0=no disease activity to 100=maximum disease activity]; 2) Patient's Global Assessment of Disease Activity [VAS: 0=no disease activity to 100=maximum disease activity]; 3) Patient's Assessment of Pain [VAS: 0=no pain to 100=unbearable pain]; 4) Health Assessment Questionnaire [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do] and 5) an acute-phase reactant (either CRP or ESR). The ACR20 response was compared to Baseline in the precursor studies WA16291 or WA17043.|24 weeks after fifth course of rituximab (median duration of 297.3 weeks)|ITT Population. Here, number of participants analyzed = participants who were evaluable for this outcome.||percentage of participants|||Number
649023|NCT02093026|Primary|Percentage of Participants With ACR20 Response After Fourth Course|A participant had an ACR20 response if there was at least a 20% improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity [VAS: 0=no disease activity to 100=maximum disease activity]; 2) Patient's Global Assessment of Disease Activity [VAS: 0=no disease activity to 100=maximum disease activity]; 3) Patient's Assessment of Pain [VAS: 0=no pain to 100=unbearable pain]; 4) Health Assessment Questionnaire [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do] and 5) an acute-phase reactant (either CRP or ESR). The ACR20 response was compared to Baseline in the precursor studies WA16291 or WA17043.|24 weeks after fourth course of rituximab (median duration of 232 weeks)|ITT Population. Here, number of participants analyzed = participants who were evaluable for this outcome.||percentage of participants|||Number
649048|NCT02092610|Secondary|Longterm Survival of Implant|"To compare the long term survival of the novel implant and abutment and the standard implant and abutment in the Baha system.
All patients will be asked if they have experienced any implant osseointegration problems which would have made the implant to get loose. The time from implant implantation until implant loss or removal will be collected. In case of implant removal, reason for removal shall be recorded."|At the single 60 months visit|Survival population, all patients in the ITT population in the original study CAG5173 (all randomized patients who get surgery).||% survival rate of implants|||Number
659257|NCT01883908|Primary|Side Effects of Acupuncture Treatment|All acupuncture side effects will be recorded|16 weeks|Zero participants analyzed due to early termination of study.|||||
649024|NCT02093026|Primary|Percentage of Participants With ACR20 Response After Third Course|A participant had an ACR20 response if there was at least a 20% improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity [VAS: 0=no disease activity to 100=maximum disease activity]; 2) Patient's Global Assessment of Disease Activity [VAS: 0=no disease activity to 100=maximum disease activity]; 3) Patient's Assessment of Pain [VAS: 0=no pain to 100=unbearable pain]; 4) Health Assessment Questionnaire [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do] and 5) an acute-phase reactant (either CRP or ESR). The ACR20 response was compared to Baseline in the precursor studies WA16291 or WA17043.|24 weeks after third course of rituximab (median duration of 162.9 weeks)|ITT Population. Here, number of participants analyzed = participants who were evaluable for this outcome.||percentage of participants|||Number
649025|NCT02093026|Primary|Percentage of Participants With ACR20 Response After Second Course|A participant had an ACR20 response if there was at least a 20% improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity [VAS: 0=no disease activity to 100=maximum disease activity]; 2) Patient's Global Assessment of Disease Activity [VAS: 0=no disease activity to 100=maximum disease activity]; 3) Patient's Assessment of Pain [VAS: 0=no pain to 100=unbearable pain]; 4) Health Assessment Questionnaire [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do] and 5) an acute-phase reactant (either CRP or ESR). The ACR20 response was compared to Baseline in the precursor studies WA16291 or WA17043.|24 weeks after second course of rituximab (median duration of 90.9 weeks)|ITT Population. Here, number of participants analyzed = participants who were evaluable for this outcome.||percentage of participants|||Number
649026|NCT02093026|Primary|Percentage of Participants With an American College of Rheumatology 20 (ACR20) Response After First Course|A participant had an ACR20 response if there was at least a 20 percent (%) improvement, ie, reduction from Baseline, in tender joint count (TJC) and swollen joint count (SJC) (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity [visual analog scale (VAS): 0=no disease activity to 100=maximum disease activity]; 2) Patient's Global Assessment of Disease Activity [VAS: 0=no disease activity to 100=maximum disease activity]; 3) Patient's Assessment of Pain [VAS: 0=no pain to 100=unbearable pain]; 4) Health Assessment Questionnaire [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do] and 5) an acute-phase reactant (either C-reactive protein [CRP] or erythrocyte sedimentation rate [ESR]). The ACR20 response was compared to Baseline in the precursor studies WA16291 or WA17043.|24 weeks after first course of rituximab (up to approximately 26 weeks)|Intent to treat (ITT) Population included all participants who received any part of an infusion of study medication under Study WA16855. Here, number of participants analyzed = participants who were evaluable for this outcome.||percentage of participants|||Number
649027|NCT02092961|Other Pre-specified|DAS-CRP Score - Comparison of Change From Baseline Between Fostamatinib and Placebo or Adalimumab|DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patient's own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. Mean changes from baseline in DAS28-CRP score are shown at each visit and are presented as decreases from baseline (defined as baseline minus post-baseline) with larger changes indicative of a better clinical condition. ANCOVA = analysis of covariance, BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, MRI = magnetic resonance imaging, PO = orally, SC = subcutaneous.|Baseline, 6 and 24 weeks|The sub-study analysis set includes those patients who received at least 1 dose of investigational product in the MRI sub-study. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Units on a scale||Standard Deviation|Mean
649028|NCT02092961|Other Pre-specified|OMERACT RAMRIS Erosions Score - Comparison of Change From Baseline Between Fostamatinib and Placebo or Adalimumab (Van Elteren)|OMERACT RAMRIS erosions score was based on 25 joints and ranged from 0 to 250 with a smaller value indicating a better clinical condition. Median changes from baseline are shown at each visit (defined as post-baseline minus baseline) with negative values indicative of a better clinical condition. BID = twice daily, CI = confidence interval, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, MRI = magnetic resonance imaging, OMERACT = Outcome Measures in Rheumatoid Arthritis Clinical Trials, PO = orally, RAMRIS = Rheumatoid Arthritis Magnetic Resonance Image Scoring system, SC = subcutaneous.|Baseline, 6 and 24 weeks|The sub-study analysis set includes those patients who received at least 1 dose of investigational product in the MRI sub-study. Patients were analysed by randomised treatment, but only those with available images were included in the analysis.||Units on a scale||Inter-Quartile Range|Median
649029|NCT02092961|Other Pre-specified|Joint Space Narrowing - Comparison of Change From Baseline Between Fostamatinib and Placebo or Adalimumab (Van Elteren)|Joint space narrowing score was based on 20 joints, scored from MRI images and ranged from 0 to 80 with a smaller value indicating a better clinical condition. Median changes from baseline are shown at each visit (defined as post-baseline minus baseline) with negative values indicative of a better clinical condition. BID = twice daily, CI = confidence interval, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, JSN = joint space narrowing, MRI = magnetic resonance imaging, PO = orally, SC = subcutaneous.|Baseline, 6 and 24 weeks|The sub-study analysis set includes those patients who received at least 1 dose of investigational product in the MRI sub-study. Patients were analysed by randomised treatment, but only those with available images were included in the analysis.||Units on a scale||Inter-Quartile Range|Median
649049|NCT02092610|Primary|Implant Stability|To show superiority of the novel implant compared to standard implants regarding stability of the implants measured as ISQ values at the abutment level. The ISQ value ranges from 1 to 100, the higher ISQ value, the higher the implant stabilty. Mean AUC 0-60 months ISQ represents a weighted average of the implant stability during the 60 months from start of the CAG5173 study to the measurement in this study CBAS5562. The ISQ 5 years value represents the single ISQ measurment at 5 years.|At the single 60 months visit|The 5 year follow up population consisted of the patients in the ITT population (all randomized subjects who received surgery) in the CAG5173 study who attended this study which was a 5-year follow up visit.||ISQ scores||Standard Deviation|Mean
649030|NCT02092961|Other Pre-specified|OMERACT RAMRIS Osteitis Score - Comparison of Change From Baseline Between Fostamatinib and Placebo or Adalimumab (Van Elteren)|OMERACT RAMRIS osteitis score was based on 25 joints, scored from MRI images, and ranged from 0 to 75 with a smaller value indicating a better clinical condition. Median changes from baseline are shown at each visit (defined as post-baseline minus baseline) with negative values indicative of a better clinical condition. BID = twice daily, CI = confidence interval, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, MRI = magnetic resonance imaging, OMERACT = Outcome Measures in Rheumatoid Arthritis Clinical Trials, PO = orally, RAMRIS = Rheumatoid Arthritis Magnetic Resonance Image Scoring system, SC = subcutaneous.|Baseline, 6 and 24 weeks|The sub-study analysis set includes those patients who received at least 1 dose of investigational product in the MRI sub-study. Patients were analysed by randomised treatment, but only those with available images were included in the analysis.||Units on a scale||Inter-Quartile Range|Median
649031|NCT02092961|Primary|OMERACT RAMRIS Synovitis Score - Comparison of Change From Baseline Between Fostamatinib and Placebo or Adalimumab (Van Elteren)|OMERACT RAMRIS synovitis score was based on 8 joints, scored from MRI images, and ranged from 0 to 24 with a smaller value indicating a better clinical condition. Median changes from baseline are shown at each visit (defined as post-baseline minus baseline) with negative values indicative of a better clinical condition. BID = twice daily, CI = confidence interval, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, MRI = magnetic resonance imaging, OMERACT = Outcome Measures in Rheumatoid Arthritis Clinical Trials, PO = orally, RAMRIS = Rheumatoid Arthritis Magnetic Resonance Image Scoring system, SC = subcutaneous.|Baseline, 6 and 24 weeks|The sub-study analysis set includes those patients who received at least 1 dose of investigational product in the MRI sub-study. Patients were analysed by randomised treatment, but only those with available images were included in the analysis.||Units on a scale||Inter-Quartile Range|Median
649032|NCT02092857|Primary|Number of Antigen-presenting B Cells||10 weeks|||percentage of CD20+ B cells|||Number
649033|NCT02092662|Secondary|Handwriting Off-paper Time.|Assessed by electronic tablet with specific software called ComPET. Patient make writing tasks. The time the pen is on air is measured. The data from the tablet passed to the computer to be processed by the software.|T1 at the beginning of the hospital stay and folloew up at T2 one mont...||||||
649034|NCT02092662|Secondary|Handwriting Pressure.|Assessed by electronic tablet with specific software called ComPET. Patient make writing tasks, and the pressure exerted with the pen on the tablet is recorded. The data from the tablet passed to the computer to be processed by the software.|T1 at the beginning of the hospital stay and folloew up at T2 one mont...||||||
649035|NCT02092662|Secondary|% Maximum Voluntary Contraction.|T1 at the beginning of the hospital stay and folloew up at T2 one month later.|The outcome will be measured twice. First at the beginning of the hospital stay and again at the end of the hospital stay, that is 4 weeks on average.||||||
649036|NCT02092662|Primary|Muscle Onset Time.|Assessed by surface electromyography device. The time period it takes the muscle to be activated and contract from a voice prompting is measured. Shorter time onset probably charcterized healthy people compared to patients after a stroke.|the study group was assessed T1 at the beginning of the hospital stay and follow up at T2 one month later. The control group assessed for the the time onset and compared to the study group at T1|||seconds||Standard Deviation|Mean
649037|NCT02092662|Secondary|Handwriting Velocity|Assessed by electronic tablet with specific software called ComPET. Patient make writing tasks. The velocity of his writing is measured and pass from the tablet to the computer to be processed by the software.|T1 at the beginning of the hospital stay and follow up at T2 one month later.||||||
649038|NCT02092662|Secondary|Muscle Co-activation Index.|Assessed by surface electromyography device. Indicate for the level by which muscles contract at the same time and amplitude. It will be calculated in percentage from 100%, as 100% indicate for complete co-activation between a pair of muscles.|T1 at the beginning of the hospital stay and folloew up at T2 one month later.||||||
649039|NCT02092662|Primary|Fugl-Meyer Assessment.|zero to 66 points scale, measuring the impairment level of the upper extremity. Zero indicates a high level of impairment or minimum hand motor function, while 66 points indicates an increased motor function which is similar to normal upper extremity function.|T1 at the beginning of the hospital stay and folloew up at T2 one month later.|||units on a scale||Standard Deviation|Mean
649040|NCT02092649|Secondary|Change in Fasted Blood Triglyceride Concentration From Baseline||Baseline, 12 weeks|||percent change||Standard Deviation|Mean
649041|NCT02092649|Secondary|Variability of Resting Metabolic Rate Measurement on 2 Consecutive Days||Baseline, 6 weeks, 12 weeks|||percent variability||Standard Deviation|Mean
649042|NCT02092649|Secondary|Change in Whole Body Resting Carbohydrate Oxidation From Baseline||Baseline, 6 weeks, 12 weeks|||percent change||Standard Deviation|Mean
649043|NCT02092649|Secondary|Change in Whole Body Resting Fat Oxidation From Baseline||Baseline, 6 weeks, 12 weeks|||percent change||Standard Deviation|Mean
649044|NCT02092649|Secondary|Change in Maximum Oxygen Consumption From Baseline||Baseline, 12 weeks|||percent change||Standard Deviation|Mean
649045|NCT02092649|Primary|Change in Resting Metabolic Rate From Baseline|Percent change in resting metabolic rate|Baseline, 6 weeks, 12 weeks|||percent change||Standard Deviation|Mean
649046|NCT02092610|Secondary|Implant Survival||60 months|"These data are already presented in the Longterm Survival of Implant section."|||||
649047|NCT02092610|Secondary|Soft Tissue Status|"To evaluate the status of the soft tissue at the implant site.
The scale Holgers Index 4 is designed to capture signs and symptoms of inflammation or infection at the site of implantation. The scale should be completed at the visit.
The scale consists of the following steps:
0. No irritation. Epidermal debris removed, if present
Slight redness. Local temporary treatment, if needed
Red and slightly moist tissue. No granulation formation, local treatment and extra controls as indicated
Reddish and moist; sometimes granulations tissue, revision surgery is indicated
Removal of the abutment/implant necessary due to infection R. Removal of abutment/implant for reasons not related to skin problems"|At the single 60 months visit|Five year follow up population||% of participants|||Number
649050|NCT02092441|Other Pre-specified|Satisfaction Measured on a 5-point Likert Scale|"Patient satisfaction of smelling prep pad to alleviate nausea on a scale from 1 (completely unsatisfied) to 5 (completely satisfied)"|10 minutes post intervention|||5 point Likert Scale||Inter-Quartile Range|Median
649054|NCT02092389|Secondary|Correlation Between fC and Workability Determined by WPAI:UC Questionnaire|Fecal calprotectin (fC) is a non-invasive surrogate marker of inflammation in the small intestine and levels below 250 ug/g is associated with mucosal healing. fC levels were measured using enzyme-linked immunosorbent assay (ELISA) and/or a validated quantitative rapid test. The WPAI:UC is a questionnaire used to evaluate lost productivity (work time missed and work and activity impairment) during the past 7 days due to UC. The scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.|Baseline (Day 0) to Month 12|The study was terminated due to low enrollment and data were not collected.|||||
649055|NCT02092389|Secondary|Correlation Between fC and Patient's QoL Determined by the sIBDQ|fC is a non-invasive surrogate marker of inflammation in the small intestine and levels below 250 ug/g is associated with mucosal healing. fC levels were measured using enzyme-linked immunosorbent assay (ELISA) and/or a validated quantitative rapid test. The sIBDQ is a disease-specific health-related QoL questionnaire, able to detect and define meaningful clinical changes in IBD patients by measuring physical, social and emotional status. The sIBDQ consists of 10 questions, each question is scored on a scale from 1 (poor QoL) to 7 (good QoL). The scores are summed up and divided by 10 for a mean score ranging from 1 (poor QoL) to 7 (good QoL).|Baseline (Day 0) to Month 12|The study was terminated due to low enrollment and data were not collected.|||||
649056|NCT02092389|Secondary|Correlation Between fC and Disease Activity Determined by Partial Mayo Score|Fecal calprotectin (fC) is a non-invasive surrogate marker of inflammation in the small intestine and levels below 250 ug/g is associated with mucosal healing. fC levels were measured using enzyme-linked immunosorbent assay (ELISA) and/or a validated quantitative rapid test. A partial mayo score (mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and PGA).|Baseline (Day 0) to Month 12|The study was terminated due to low enrollment and data were not collected.|||||
649057|NCT02092389|Secondary|Change From Baseline to Month 12 in Disease Activity Determined by Partial Mayo Score|A partial mayo score (mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment [PGA]).|Baseline (Day 0) to Month 12|The study was terminated due to low enrollment and data were not collected.|||||
649058|NCT02092389|Secondary|Change From Baseline to Month 12 in Patient's Quality of Life (QoL) Measured Using the Short Inflammatory Bowl Disease Questionnaire (sIBDQ)|The sIBDQ is a disease-specific health-related quality of life (QoL) questionnaire, able to detect and define meaningful clinical changes in inflammatory bowel disease (IBD) patients by measuring physical, social and emotional status. The sIBDQ consists of 10 questions, each question is scored on a scale from 1 (poor QoL) to 7 (good QoL). The scores are summed up and divided by 10 for a mean score ranging from 1 (poor QoL) to 7 (good QoL). Increased scores correspond to an improvement in QoL.|Baseline (Day 0) to Month 12|The study was terminated due to low enrollment and data were not collected.|||||
649059|NCT02092389|Secondary|Change From Baseline to Month 12 in Patient's Workability Measured Using the Work Productivity and Activity Impairment:Ulcerative Colitis (WPAI:UC) Questionnaire|The WPAI:UC is a questionnaire used to evaluate lost productivity (work time missed and work and activity impairment) during the past 7 days due to UC. The scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Change in WPAI-UC is calculated by deducting the final score from the baseline score. Increased (positive) scores correspond to a reduction in the percentage of lost work productivity.|Baseline (Day 0) to Month 12|The study was terminated due to low enrollment and data were not collected.|||||
649060|NCT02092389|Primary|Percentage of Patients With Fecal Calprotectin (fC) Level ≤ 150 µg/g After 12 Months of Treatment With Adalimumab|Fecal calprotectin (fC) is a non-invasive surrogate marker of inflammation in the small intestine and levels below 250 ug/g is associated with mucosal healing. fC levels were measured using enzyme-linked immunosorbent assay (ELISA) and/or a validated quantitative rapid test. The study was terminated due to low enrollment. Although no meaningful analysis can be presented, data for subjects with available data for fC levels at Month 12 at the end of study (termination) are provided.|Month 12|Enrolled participants with Month 12 data at the time of study termination||percentage of participants|||Number
649061|NCT02092350|Secondary|Percentage of Participants With Sustained Virologic Response 4 Weeks After Completing Study Therapy (SVR4)|SVR4 was defined as HCV RNA <LLoQ 4 weeks after completing study therapy. HCV RNA was measured using the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0®, which has a LLoQ of 15 IU/mL.|Week 16 (Immediate Treatment + Intensive PK) or Week 32 (Deferred Treatment)|The mFAS includes all participants receiving ≥1 dose of drug and without missing data due to death or early discontinuation from study therapy for reasons unrelated to response to HCV treatment.||Percentage of participants||95% Confidence Interval|Number
649062|NCT02092350|Secondary|Percentage of Participants With Sustained Virologic Response 24 Weeks After Completing Study Therapy (SVR24)|SVR24 was defined as HCV RNA <LLoQ 24 weeks after completing study therapy. HCV RNA was measured using the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0®, which has a LLoQ of 15 IU/mL.|Week 36 (Immediate Treatment + Intensive PK) or Week 52 (Deferred Treatment)|The mFAS includes all participants receiving ≥1 dose of drug and without missing data due to death or early discontinuation from study therapy for reasons unrelated to response to HCV treatment.||Percentage of participants||95% Confidence Interval|Number
649063|NCT02092350|Primary|Number of Participants Discontinuing Study Drug Due to AEs During the Initial Treatment Period|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. This analysis includes the Immediate Treatment + Intensive PK group and the placebo treatment period for the Deferred Treatment group.|Up to Week 12|The APaT population includes all enrolled participants who received at least one dose of study drug.||Participants|||Number
649064|NCT02092350|Primary|Number of Participants Experiencing an Adverse Event (AE) During the Initial Treatment and 14-day Follow-up Periods|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. This analysis includes the Immediate Treatment + Intensive PK group and the placebo treatment period for the Deferred Treatment group.|Up to Week 14|The All Participants as Treated (APaT) population includes all enrolled participants who received at least one dose of study drug.||Participants|||Number
649065|NCT02092350|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Completing Study Therapy (SVR12)|SVR12 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) lower than the limit of quantification (LLoQ) 12 weeks after completing study therapy. HCV RNA was measured using the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0®, which has a LLoQ of 15 IU/mL.|Week 24 (Immediate Treatment + Intensive PK) or Week 40 (Deferred Treatment)|The modified Full Analysis set (mFAS) includes all participants receiving ≥1 dose of drug and without missing data due to death or early discontinuation from study therapy for reasons unrelated to response to HCV treatment.||Percentage of participants||95% Confidence Interval|Number
649066|NCT02092311|Other Pre-specified|Post-varicocelectomy Testicular Atrophy|development of testicular atrophy is assessed by physical exam at intervals of 3 and 6 months after surgery|6months|||Participants|||Number
649067|NCT02092311|Secondary|Post-varicocelectomy Hydrocele|Development of hydrocele is assessed by physical exam at intervals of 10 days,3months and 6months after surgery|6months|||Participants|||Number
649068|NCT02092311|Primary|Recurrent Varicocele|post-varicocelectomy recurrence is measured by physical exam at intervals of 10 days,3months and 6months after surgery|6 months|||participants|||Number
649069|NCT02092168|Primary|AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to Last Observed Concentration|AUC0-t - Area under the plasma concentration-time curve of BIA 9-1067 from time 0 to last observed concentration|Day 1 and Day 7|||ng.h/mL||Standard Deviation|Mean
649070|NCT02092168|Primary|Tmax - Time to Reach Cmax|Tmax - Time to reach maximum plasma concentration of BIA 9-1067|Day 1 and Day 7|||hours||Full Range|Median
649071|NCT02092168|Primary|Cmax - Maximum Plasma Concentration|Cmax (BIA 9-1067) - maximum plasma concentration of BIA 9-1067|Day 1 and Day 7|||ng/mL||Standard Deviation|Mean
649072|NCT02092116|Secondary|Part B: Level of HIV-1 Transcription.|At day 105, 112 and 119 patients receive romidepsin and 4 hours after each administration HIV transcription is measured as unspliced HIV-1 RNA.|Day 105, 112 and 119|All available samples were included in this analysis; 3 withdrew consent and 2 (3 for day 119) did not have analyzable samples.||copies/10^6 CD4+ T cells||Standard Deviation|Mean
649073|NCT02092116|Secondary|Part B: Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|Safety and tolerability evaluation of romidepsin and Vacc-4x in combination with GM-CSF as measured by adverse events (AE) and serious adverse events (SAE).|287 days|||participants|||Number
649074|NCT02092116|Secondary|Part A: Changes From Baseline in HIV-1 Reservoir (Total HIV-1DNA; Integrated HIV-1 DNA in Unfractionated CD4+ T Cells and Replication Competent Provirus. Estimates of Change From Baseline of the Size of the Latent HIV-1 Reservoir in CD4+ Cells.|"Total HIV-1 DNA and integrated HIV-1 DNA were analysed by MMRM analysis (copies/10^6 CD4+ T cells). To estimate the frequency of infectious units per 10^6 resting memory CD4+ T cells a quantitative viral outgrowth assay (qVOA) was used.
Total HIV-1 DNA was measured at Day 84"|Day 56/84|1 patient did not have a quantifiable load of total HIV-1 DNA at Day 84 and 2 patients diod not have a quantifiable load of replication competent provirus at day 56.||copies/10^6 CD4+ T cells||Standard Deviation|Mean
649075|NCT02092116|Primary|Part B: Changes From Baseline in HIV-1 Reservoir (Total HIV-1DNA; Integrated HIV-1 DNA in Unfractionated CD4+ T Cells and Replication Competent Provirus.|"Total HIV-1 DNA and integrated HIV-1 DNA were analysed by MMRM analysis (copies/10^6 CD4+ T cells). To estimate the frequency of infectious units per 10^6 resting memory CD4+ T cells a quantitative viral outgrowth assay (qVOA) was used.
Blood samples were obtained at Day 0, Day 105 and Day 161."|Day 161/175|"4 patients were excluded; 3 discontinued and 1 sample was not eligible for analysis.
Sensitivity of the qVOA was low; 2/3 of all measurements were under the limit of detection. 6 subjects had quantifiable viral outgrowth on baseline, 8 had viral outgrowth after immunization (Day 105) and 6 had viral outgrowth after romidepsin (Day 161)."||Estimated % change from baseline||95% Confidence Interval|Mean
649076|NCT02092116|Primary|Part A: Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|Safety and tolerability evaluation as measured by adverse events (AE) and serious adverse events (SAE).|3 weeks|||participants|||Number
649077|NCT02091986|Secondary|Number of Patients With an Asthma Exacerbation During Study|Number of patients that experienced an asthma exacerbation that required either emergency room treatment, hospitalization, systemic steroids, or an increase in, or additional asthma maintenance medication, during the study.|Week 0 (baseline) up to Week 12|"All patients randomized who:
received at least one dose of study medication;
data collected after randomisation. Patients accounted for according to the treatment they actually received."||Partcicipants|||Number
649078|NCT02091986|Secondary|Change From Baseline to Study Period Average in Overall PAQLQ Score|"Study period average is defined as the average of the post-baseline values during the study taken after first dose of investigational product up to and including withdrawal from study or Week 12, minus the baseline assessment at randomization, for patients who remain in the study (irrespective of whether IP has been discontinued).
The PAQLQ(S) is a 23-item patient-reported questionnaire, each one reported on a 7-point scale (e.g. 1 = extremely bothered/all of the time; 7 = not bothered/none of the time). The PAQLQ(S) generates an overall score, as well as 3 domain scores: activity limitations (5 items), symptoms (10 items) and emotional function (8 items). The overall score will be calculated as the mean of the responses to each of the 23 questions (ie the range of 1–7, where higher scores indicate better quality of life). If any of the domain scores are missing, no total score will be calculated."|Week 0 (baseline), week 4, week 8, week 12|"All patients randomized who:
received at least one dose of study medication;
the patient contributed data for at least one efficacy endpoint. Patients accounted for according to the treatment to which they were randomized."||unit on a scale||95% Confidence Interval|Least Squares Mean
649079|NCT02091986|Secondary|Change From Baseline to End of Study Average in Total Daily Reliever Medication|End of study average is defined as the average of available records from 7 days before up to and including the day prior to withdrawal from study or Week 12, minus the baseline measurement at randomization, for patients who remain in the study (irrespective of whether IP has been discontinued).|Week 0 (baseline), Week 12|"All patients randomized who:
received at least one dose of study medication;
the patient contributed data for at least one efficacy endpoint. Patients accounted for according to the treatment to which they were randomized."||Number of reliever medication use||Standard Deviation|Mean
649243|NCT02084797|Other Pre-specified|Performance|To determine if exercise performance, as determined by overall exercise time, was affected in response to the V2R antagonist, agonist and placebo conditions.|4 trials (4 weeks)||||||
649080|NCT02091986|Secondary|Change From Baseline to End of Study Average in % of Night Time Awakenings Due to Asthma Symptoms|End of study average is defined as the percentage of nighttime awakenings due to asthma symptoms from 6 days before up to and additionally including the morning of withdrawal from study or Week 12, minus the baseline measurement at randomization, for patients who remain in the study (irrespective of whether IP has been discontinued).|Week 0 (baseline), Week 12|"All patients randomized who:
received at least one dose of study medication;
the patient contributed data for at least one efficacy endpoint. Patients accounted for according to the treatment to which they were randomized."||Percentage of nighttime awakenings||Standard Deviation|Mean
649081|NCT02091986|Secondary|Change From Baseline to End of Study Average in Total Asthma Symptoms|"End of study average is defined as the average of available records from 7 days before up to and including the day prior to withdrawal from study or Week 12, minus the baseline measurement at randomization, for patients who remain in the study (irrespective of whether IP has been discontinued).
Patient to record his/her asthma symptom score twice daily. The following rating scales are to be used: 0 = None; no symptoms of asthma
= Mild symptoms; awareness of asthma symptoms and/or signs that are easily tolerated
= Moderate symptoms, asthma symptoms with some discomfort, causing some interference with daily activities or sleep
= Severe symptoms; incapacitating asthma symptoms and/or signs, with inability to perform daily activities or to sleep
Total asthma symptom score is derived as the sum of the daytime score plus the score from the previous nighttime, ie possible range (0 to 6)."|Week 0 (baseline), Week 12|"All patients randomized who:
received at least one dose of study medication;
the patient contributed data for at least one efficacy endpoint. Patients accounted for according to the treatment to which they were randomized."||units on a scale||Standard Deviation|Mean
649082|NCT02091986|Secondary|Change From Baseline to Week 12 in 15 Min Post-dose FEV1|15 min Post-dose FEV1 is defined as the 15 min post-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).|Week 0 (baseline), Week 12|"All patients randomized who:
received at least one dose of study medication;
the patient contributed data for at least one efficacy endpoint. Patients accounted for according to the treatment to which they were randomized."||Liters||95% Confidence Interval|Least Squares Mean
649083|NCT02091986|Secondary|Change From Baseline to Week 12 in Pre-dose FVC|Pre-dose FVC is defined as the pre-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).|Week 0 (baseline), Week 12|"All patients randomized who:
received at least one dose of study medication;
the patient contributed data for at least one efficacy endpoint. Patients accounted for according to the treatment to which they were randomized."||Liters||95% Confidence Interval|Least Squares Mean
649084|NCT02091986|Secondary|Change From Baseline to Week 12 in Pre-dose FEF25-75|Pre-dose FEF25-75 is defined as the pre-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).|Week 0 (baseline), Week 12|"All patients randomized who:
received at least one dose of study medication;
the patient contributed data for at least one efficacy endpoint. Patients accounted for according to the treatment to which they were randomized."||Liters per minute||95% Confidence Interval|Least Squares Mean
649085|NCT02091986|Secondary|Change From Baseline to Week 12 in Pre-dose PEF|Pre-dose PEF is defined as the pre-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).|Week 0 (baseline), Week 12|"All patients randomized who:
received at least one dose of study medication;
the patient contributed data for at least one efficacy endpoint. Patients accounted for according to the treatment to which they were randomized."||Liters per minute||95% Confidence Interval|Least Squares Mean
649086|NCT02091986|Secondary|Change From Baseline to Week 12 in Pre-dose FEV1|Pre-dose FEV1 is defined as the pre-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).|Week 0 (baseline), Week 12|"All patients randomized who:
received at least one dose of study medication;
the patient contributed data for at least one efficacy endpoint. Patients accounted for according to the treatment to which they were randomized."||Liters||95% Confidence Interval|Least Squares Mean
649087|NCT02091986|Secondary|Change From Baseline to Week 12 in 1h Post-dose FVC|1h post-dose FVC is defined as the 1-hour post-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).|Week 0 (baseline), Week 12|"All patients randomized who:
received at least one dose of study medication;
the patient contributed data for at least one efficacy endpoint. Patients accounted for according to the treatment to which they were randomized."||Liters||95% Confidence Interval|Least Squares Mean
649088|NCT02091986|Secondary|Change From Baseline to Week 12 in 1h Post-dose FEF25-75|1h post-dose FEF25-75 is defined as the 1-hour post-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).|Week 0 (baseline), Week 12|"All patients randomized who:
received at least one dose of study medication;
the patient contributed data for at least one efficacy endpoint. Patients accounted for according to the treatment to which they were randomized."||Liters per second||95% Confidence Interval|Least Squares Mean
649089|NCT02091986|Secondary|Change From Baseline to Week 12 in 1h Post-dose PEF|1h post-dose PEF is defined as the 1-hour post-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).|Week 0 (baseline), Week 12|"All patients randomized who:
received at least one dose of study medication;
the patient contributed data for at least one efficacy endpoint.
Patients accounted for according to the treatment to which they were randomized."||Liters per minute||95% Confidence Interval|Least Squares Mean
649090|NCT02091986|Primary|Change From Baseline to Week 12 in 1h Post-dose FEV1|1h post-dose FEV1 is defined as the 1-hour post-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).|Week 0 (baseline), Week 12|"All patients randomized who:
received at least one dose of study medication;
the patient contributed data for at least one efficacy endpoint.
Patients accounted for according to the treatment to which they were randomized."||Liters||95% Confidence Interval|Least Squares Mean
649095|NCT02091856|Primary|Beck Depression Inventory II (BDI-II)|"The Beck Depression Inventory-II (BDI-II) was designed to measure participant’s level of depression. The scale is unidimensional and the total score rages from 0 to 63. Low scores are associated with low levels of depression, while high scores are associated with high levels of depression.
This represents the measure of depression at 6 month after the intervention."|Absolute values (average score) of BDI-II at 37 weeks (follow-up)|Only 10 participants from the C-CBT and 9 participants from the R-CBT completed the follow-up assessment questionnaires. Participants from the Wailt-List Control Group were lost at follow-up.||units on a scale||Standard Deviation|Mean
649096|NCT02091856|Secondary|Quick Inventory of Depressive Symptomatology – Self Report (QIDS-SR)|"The Quick Inventory of Depressive Symptomatology – Self Report (QIDS-SR) was designed to measure participant’s level of depression. The scale is unidimensional and the total score rages from 0 to 27. Low scores are associated with low levels of depression, while high scores are associated with high levels of depression.
This represents a secondary outcome measure for depression taken immediately after the intervention."|Absolute values (average score) of QIDS-SR after 11 weeks (post-treatment)|||units on a scale||Standard Deviation|Mean
649097|NCT02091856|Secondary|Quality of Life Inventory (QOLI)|"The Quality of Life Inventory (QOLI) is an established rating scale of self-perceived quality of life across 16 domains. The scale is unidimensional and the total score rages from -6 to +6. Low scores are associated with low self-perceived life quality, while high scores are associated with high self-perceived life quality.
This represents the post-intervention assessment."|Absolute values (average score) of QOLI at 11 weeks (post-intervention)|||units on a scale||Standard Deviation|Mean
649098|NCT02091856|Secondary|Beck Anxiety Inventory (BAI)|"The Beck Anxiety Inventory (BAI) was designed to measure participant’s level of anxiety. The scale is unidimensional and the total score rages from 0 to 63. Low scores are associated with low levels of anxiety, while high scores are associated with high levels of anxiety.
This represent the post-intervention assessment."|Absolute values (average score) of Back Anxiety Inventory at 11 weeks (post-intervention)|||units on a scale||Standard Deviation|Mean
649099|NCT02091856|Primary|Beck Depression Inventory-II (BDI-II)|"The Beck Depression Inventory-II (BDI-II) was designed to measure participant’s level of depression. The scale is unidimensional and the total score rages from 0 to 63. Low scores are associated with low levels of depression, while high scores are associated with high levels of depression.
This represents the post-intervention assessment."|Absolute values (average score) of Back Depression Inventory-II at 11 weeks (post-intervention)|||units on a scale||Standard Deviation|Mean
649100|NCT02091778|Primary|Change in Peri-wound Skin|Measured by the following variables; maceration, redness/irritation, rash/eczema, blistering, dermatitis, skin stripping, trauma to wound edges and product degradation on the skin|12 weeks|number of patients with healthy/intact peri-wound skin that increased from baseline to final visit. (From 6 to 14)||participants|||Number
649101|NCT02091752|Secondary|Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and EuroQol (EQ)-5D-5L Scores||Baseline, Day 1, Week 8, Week 12, Week 16, Week 24|The study was terminated early due to low enrollment. Analysis was not done.|||||
649102|NCT02091752|Secondary|Patient Global Impression of Change (PGIC) Score||Week 1, Week 24|The study was terminated early due to low enrollment. Analysis was not done.|||||
649103|NCT02091752|Secondary|Change From Baseline in MPN-SAF TSS Score||Baseline, Week 24|The study was terminated early due to low enrollment. Analysis was not done.|||||
649114|NCT02091466|Primary|Maternal Hypothermia|Hypothermia was measured by means of tympanic temperatures.|60 minutes|Sample size was calculated to be 20 subjects in each group to ensure that a difference of 0.5ºC at 60 minutes could be detected at significance level of 5% with a statistical power of 90%, assuming the standard deviation of differences to be 0.5ºC, considering a temperature below 36.0ºC could be considered hypothermia||Centigrades||Standard Deviation|Mean
649115|NCT02091414|Secondary|Percentage of Participants With Abnormal Serum Creatinine and BUN Values at Baseline and During Treatment||Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24|ITT population||percentage of participants|||Number
649116|NCT02091414|Secondary|Percentage of Participants With Abnormal Serum Creatinine and BUN Values at Baseline and Normal Values During Treatment||Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24|ITT population||percentage of participants|||Number
649117|NCT02091414|Secondary|Percentage of Participants With Normal Serum Creatinine and BUN Values at Baseline and Abnormal Values During Treatment||Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24|ITT population||percentage of participants|||Number
649118|NCT02091414|Secondary|Percentage of Participants With Normal Serum Creatinine and Blood Urea Nitrogen (BUN) Values At Baseline (BL) And During Treatment||Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24|ITT population||percentage of participants|||Number
649119|NCT02091414|Secondary|Percentage of Participants Lost To Follow Up Within 24 Weeks of Transplantation||Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24|ITT population||percentage of participants|||Number
649120|NCT02091414|Secondary|Percentage of Participants Discontinuing Immunosuppressants (MMF) for More Than 14 Consecutive Days or 30 Cumulative Days Within 24 Weeks of Transplantation||Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24|ITT population||percentage of participants||95% Confidence Interval|Number
649121|NCT02091414|Secondary|Percentage of Participants Requiring Use of Additional Immunosuppressants Not Specified in the Protocol Within 24 Weeks of Transplantation||Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24|ITT population||percentage of participants|||Number
649122|NCT02091414|Secondary|Percentage of Participants With Graft Loss Within 24 Weeks of Transplantation||Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24|ITT population||percentage of participants|||Number
649123|NCT02091414|Primary|Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) by Week|Percentage of participants with BPAR of greater than or equal to (≥) International Society of Heart and Lung Transplant (ISHLT) Grade III. The ISHLT graded symptoms on a scale of Grade 0 through VI. Grade 0 equals (=) no rejection. Grade IA = regional (perivascular or interstitial) infiltration and no necrosis, and grade IB = dissemination but little infiltration and no necrosis. Grade II = 1 focus of invasive infiltration with or without (+/-) associated cardiomyocyte necrosis. Grade IIIA = 2 or more foci of invasive infiltration +/- associated cardiomyocyte necrosis, and grade IIIB = diffuse inflammatory pathological changes associated with cardiomyocyte necrosis. Grade IV = diffuse, infiltrative multi-foci +/- edema; +/- hemorrhage; and +/-vasculitis.|Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24|ITT population||percentage of participants||95% Confidence Interval|Number
649124|NCT02090855|Secondary|Specificity Percentage of Blinded Visual PET Image Interpretations|Specificity of blinded visual image interpretations according to neuropathological criteria, which is defined as the neuritic plaque density, neurofibriilary tangles and vasculpoathy in the brain.|Brain images will be assessed up to 1 year post subject's death.|There are 30 autopsy cases confirmed to be normal. The majority interpretation is the interpretation made independently by more than half of the readers.||Percentage of Specificity|||Number
649125|NCT02090855|Primary|Sensitivity Percentage of Blinded Visual PET Image Interpretations of Subjects With Abnormal Scans|Blinded visual assessment of each subject's Flutemetamol (18F) Injection brain PET images as positive or negative will be performed by 5 independent blinded readers trained in the interpretation of [18F]flutemetamol PET images through an electronic training program.|Brain images will be assessed up to 1 year post subject's death.|There are 76 autopsy cases confirmed to be abnormal. The majority interpretation is the interpretation made independently by more than half of the readers.||Percent of Sensitivity|||Number
649126|NCT02090855|Secondary|Number of Blinded Visual PET Image Interpretations|Specificity of blinded visual image interpretations according to neuropathological criteria.|Brain images will be assessed up to 1 year post subject's death.|There are 30 autopsy cases confirmed to be normal. The majority interpretation is the interpretation made independently by more than half of the readers.||Number of Blinded Image Intrepretations|||Number
649127|NCT02090855|Primary|The Number of Abnormal Blinded Visual PET Image Interpretations.|Blinded visual assessment of each subject's Flutemetamol (18F) Injection brain PET images as positive or negative will be performed by 5 independent blinded readers trained in the interpretation of [18F]flutemetamol PET images through an electronic training program.|Brain images will be assessed up to 1 year post subject's death.|There are 76 autopsy cases confirmed to be abnormal. The majority interpretation is the interpretation made independently by more than half of the readers.||Number of Blinded Image Interpretations|||Number
649128|NCT02090777|Primary|Glaucoma Medication Adherence|Glaucoma medication adherence will be tracked using a dose recording device to record eye drop usage. The average of the participants percentage of time they adhered to using the medication will be reported.|6 Months|||percentage of adherence time||Standard Deviation|Mean
649129|NCT02090764|Primary|Clinical Success|"Clinical response (clinical success or clinical failure) at end of therapy (Visit 3) in the intent to treat clinical (ITTC) population.
Clinical success at V3 was defined as: SIRS score 0 for blistering, exudates/pus, crusting and itching/pain and no more than 1 for erythema/inflammation such that no additional antimicrobial therapy in the baseline (Visit 1) affected area is necessary.
The skin infection rating scale (SIRS) is a severity index based on five signs or symptoms: blistering, exudate/pus, crusting, erythema/inflammation, itching/pain."|Visit 3 (Day 6-7)|"Intent-to-treat clinical (ITTC) population was defined as all randomized patients.
The % of clinical success for the treatment comparison were calculated excluding the unable to determine: OZN (112/203), PLB (78/199)"||percentage of Participants|||Number
649130|NCT02090413|Secondary|Change From Baseline to Week 24 and Week 48 in Quality of Life Measurements as Assessed by the EQ-VAS|For the EQ-VAS, the participant was instructed to draw a line on a 20-cm vertical scale at the point that best describes his or her own health, where 0 represents the “worst imaginable health state” and 100 represents the “best imaginable health state.”|Baseline, Week 24, Week 48 or ET|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug); n=number of participants with an assessment at given timepoint.||units on a scale||Standard Deviation|Mean
649131|NCT02090413|Secondary|Change From Baseline to Week 24 and Week 48 in Quality of Life Measurements as Assessed by the EQ-5D-5L Questionnaire: Anxiety/Depression|EQ-5D-5L is a standardized, subject-rated instrument for use as a measure of health outcomes. The EQ 5D-5L includes 2 components: the EQ-5D-5L descriptive system and the EQ-VAS. The EQ-5D-5L descriptive system provides a profile of the participant’s health state in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each dimension, the participant is instructed to indicate whether he or she has “no problems” (1), “some problems” (2), or “severe problems” (3). A negative change from Baseline indicates improvement.|Baseline, Week 24, Week 48 or ET|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug); n=number of participants with an assessment at given timepoint.||units on a scale||Standard Deviation|Mean
649132|NCT02090413|Secondary|Change From Baseline to Week 24 and Week 48 in Quality of Life Measurements as Assessed by the EQ-5D-5L Questionnaire: Pain/Discomfort|EQ-5D-5L is a standardized, subject-rated instrument for use as a measure of health outcomes. The EQ 5D-5L includes 2 components: the EQ-5D-5L descriptive system and the EQ-VAS. The EQ-5D-5L descriptive system provides a profile of the participant’s health state in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each dimension, the participant is instructed to indicate whether he or she has “no problems” (1), “some problems” (2), or “severe problems” (3). A negative change from Baseline indicates improvement.|Baseline, Week 24, Week 48 or ET|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug); n=number of participants with an assessment at given timepoint.||units on a scale||Standard Deviation|Mean
649133|NCT02090413|Secondary|Change From Baseline to Week 24 and Week 48 in Quality of Life Measurements as Assessed by the EQ-5D-5L Questionnaire: Usual Activities|EQ-5D-5L is a standardized, subject-rated instrument for use as a measure of health outcomes. The EQ 5D-5L includes 2 components: the EQ-5D-5L descriptive system and the EQ-VAS. The EQ-5D-5L descriptive system provides a profile of the participant’s health state in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each dimension, the participant is instructed to indicate whether he or she has “no problems” (1), “some problems” (2), or “severe problems” (3). A negative change from Baseline indicates improvement.|Baseline, Week 24, Week 48 or ET|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug); n=number of participants with an assessment at given timepoint.||units on a scale||Standard Deviation|Mean
649134|NCT02090413|Secondary|Change From Baseline to Week 24 and Week 48 in Quality of Life Measurements as Assessed by the EQ-5D-5L Questionnaire: Self-Care|EQ-5D-5L is a standardized, subject-rated instrument for use as a measure of health outcomes. The EQ 5D-5L includes 2 components: the EQ-5D-5L descriptive system and the EQ-VAS. The EQ-5D-5L descriptive system provides a profile of the participant’s health state in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each dimension, the participant is instructed to indicate whether he or she has “no problems” (1), “some problems” (2), or “severe problems” (3). A negative change from Baseline indicates improvement.|Baseline, Week 24, Week 48 or ET|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug); n=number of participants with an assessment at given timepoint.||units on a scale||Standard Deviation|Mean
649135|NCT02090413|Secondary|Change From Baseline to Week 24 and Week 48 in Quality of Life Measurements as Assessed by the European Quality of Life 5-Dimensions Questionnaire (EQ-5D-5L) Questionnaire: Mobility|EQ-5D-5L is a standardized, subject-rated instrument for use as a measure of health outcomes. The EQ 5D-5L includes 2 components: the EQ-5D-5L descriptive system and the EQ-Visual Analog Scale (EQ-VAS). The EQ-5D-5L descriptive system provides a profile of the participant’s health state in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each dimension, the participant is instructed to indicate whether he or she has “no problems” (1), “some problems” (2), or “severe problems” (3). A negative change from Baseline indicates improvement.|Baseline, Week 24, Week 48 or ET|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug); n=number of participants with an assessment at given timepoint.||units on a scale||Standard Deviation|Mean
649136|NCT02090413|Secondary|Change From Baseline at Weeks 24 and 48 in Quality of Life Measurements as Assessed by Short Form-36 (SF-36) Questionnaire: Mental Component Summary (MCS)|SF-36 is a self-administered, generic health status questionnaire consisting of 36 questions that measure 8 health concepts: physical functioning, role limitations due to physical problems, bodily pain, general health perception, vitality, social functioning, role limitations due to emotional problems and mental health. The score for a domain is an average of the individual question scores, which are scaled 0 (worst health-related quality of life) to 100 (best health-related quality of life). Score from mental health, role emotional, social functioning, and vitality domains were averaged to calculate MCS. Total score range for MCS was 0 (lowest level of physical functioning) to 100 (highest level of physical functioning).|Baseline, Week 24, Week 48 or ET|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug); n=number of participants with an assessment at given timepoint.||units on a scale||Standard Deviation|Mean
649137|NCT02090413|Secondary|Change From Baseline at Weeks 24 and 48 in Quality of Life Measurements as Assessed by Short Form-36 (SF-36) Questionnaire: Physical Component Summary (PCS)|SF-36 is a self-administered, generic health status questionnaire consisting of 36 questions that measure 8 health concepts: physical functioning, role limitations due to physical problems, bodily pain, general health perception, vitality, social functioning, role limitations due to emotional problems and mental health. The score for a domain is an average of the individual question scores, which are scaled 0 (worst health-related quality of life) to 100 (best health-related quality of life). Score from physical function, role physical, bodily pain, and general health domains were averaged to calculate PCS. Total score range for PCS was 0 (lowest level of physical functioning) to 100 (highest level of physical functioning).|Baseline, Week 24, Week 48 or early termination (ET)|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug); n=number of participants with an assessment at given timepoint.||units on a scale||Standard Deviation|Mean
649244|NCT02084797|Other Pre-specified|Sodium Palatability Ratings|To determine if sodium preference ratings were appropriately regulated in response to the V2R antagonist, agonist and placebo conditions during exercise.|4 weeks (4 trials)||||||
649138|NCT02090413|Secondary|Number of Participants Discontinuing Treatment and Discontinuing the Study Due to Treatment-Emergent Flushing AEs in Weeks 13 to 48|A treatment-emergent AE is defined as any AE that occurs after the first administration of DMF or ASA/Placebo drug. Flushing AEs include redness, warmth, tingling, and/or itching of the skin.|Week 13 to Week 48|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug).||participants|||Number
649139|NCT02090413|Secondary|Number of Participants Discontinuing Treatment and Discontinuing the Study Due to Treatment-emergent Flushing AEs in the First 12 Weeks|A treatment-emergent AE is defined as any AE that occurs after the first administration of DMF or ASA/Placebo drug. Flushing AEs include redness, warmth, tingling, and/or itching of the skin.|Day 1 to Week 12|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug).||participants|||Number
649140|NCT02090413|Secondary|Number of Participants Experiencing Treatment-Emergent AEs, SAEs, and Discontinuations Due to AEs in Weeks 13 to 48|AE: any untoward medical occurrence that does not necessarily have a causal relationship with treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity, or; results in a congenital anomaly/birth defect. An SAE may also be any other medically important event that, in the opinion of the Investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed above. A treatment-emergent AE is defined as any AE that occurs after the first administration of DMF or ASA/Placebo drug.|Week 13 to Week 48|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug).||participants|||Number
649141|NCT02090413|Secondary|Number of Participants Experiencing Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations Due to AEs in the First 12 Weeks|AE: any untoward medical occurrence that does not necessarily have a causal relationship with treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity, or; results in a congenital anomaly/birth defect. An SAE may also be any other medically important event that, in the opinion of the Investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed above. A treatment-emergent AE is defined as any AE that occurs after the first administration of DMF or ASA/Placebo drug.|Day 1 to Week 12|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug).||participants|||Number
649142|NCT02090413|Secondary|Number of Participants With Self-Reported Flushing Events During Weeks 13 to 48|Participant-reported flushing events (which include redness, warmth, tingling, and/or itching of the skin) during Weeks 13 to 48 of treatment were recorded in the CRF.|Week 13 to Week 48|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug).||participants|||Number
649143|NCT02090413|Secondary|Duration of Flushing Episodes During Weeks 1-4, 5-8 and 9-12 of the Study, as Assessed by MFSS|Duration of participant-reported flushing events during weeks 1-4, 5-8 and 9-12 of the study recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). For participants with more than 1 flushing event during a visit interval, the average duration for the visit interval was used.|Day 1 to Week 12|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug). n=number of evaluable participants at given time period.||hours||Standard Deviation|Mean
649144|NCT02090413|Secondary|Duration of Flushing Episodes During Weeks 1-4, 5-8 and 9-12 of the Study, as Assessed by MGFSS|Duration of participant-reported flushing events during weeks 1-4, 5-8 and 9-12 of the study recorded on the eDiary as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).|Day 1 to Week 12|Although designated as a secondary endpoint, the duration of flushing events based on MGFSS could not be calculated because specific flushing events with start and end times was not captured in the MGFSS.|||||
649145|NCT02090413|Secondary|Worst Severity Scores of Overall Flushing During Weeks 5-8 and Weeks 9-12 of the Study, as Assessed by MFSS|Worst severity of participant-reported flushing events during Weeks 5-8 and Weeks 9-12 of the study recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).|Week 5 to Week 12|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug). n=number of evaluable participants at given time period.||units on a scale||Standard Deviation|Mean
649146|NCT02090413|Secondary|Worst Severity Scores of Overall Flushing During Weeks 5-8 and Weeks 9-12 of the Study, as Assessed by MGFSS|Worst severity of participant-reported flushing events during Weeks 5-8 and Weeks 9-12 of the study recorded on the eDiary as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).|Week 5 to Week 12|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug). n=number of evaluable participants at given time period.||units on a scale||Standard Deviation|Mean
649245|NCT02084797|Other Pre-specified|Thirst Rating|To determine if fluid intake behaviors were appropriately regulated in response to the V2R antagonist, agonist and placebo conditions during exercise.|4 trials (4 weeks)||||||
651785|NCT02020369|Secondary|Total Amount of Study Drug Administered Per Mild/Moderate Bleeding Episode||Through study completion|Treated Population with non-missing measurements||µg/kg per bleeding episode|Bleeding Episodes|Standard Deviation|Mean
649147|NCT02090413|Secondary|Percentage of Participants Reporting Overall Flushing Events During Weeks 5-8 and Weeks 9-12 of Treatment, as Assessed by MFSS|Participant-reported flushing events during Weeks 5-8 and Weeks 9-12 of the study recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).|Week 5 to Week 12|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug).||percentage of participants|||Number
649148|NCT02090413|Secondary|Percentage of Participants Reporting Overall Flushing Events During Weeks 5-8 and Weeks 9-12 of Treatment, as Assessed by MGFSS|Participant-reported flushing events during Weeks 5-8 and Weeks 9-12 of the study recorded on the eDiary as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).|Week 5 to Week 12|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug). n=number of evaluable participants at given time period.||percentage of participants|||Number
649149|NCT02090413|Primary|Worst Severity Scores of Overall Flushing During the First 4 Weeks of Treatment, as Assessed by MFSS|Worst severity of participant-reported flushing events during the first 4 weeks of treatment recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin.This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).|Day 1 to Week 4|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug).||units on a scale||Standard Deviation|Mean
649150|NCT02090413|Primary|Worst Severity Scores of Overall Flushing During the First 4 Weeks of Treatment, as Assessed by MGFSS|Worst severity of participant-reported flushing events during the first 4 weeks of treatment recorded on the eDiary as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). Day 1 data are not included in the analysis because MGFSS question refers to last 24 hours flushing score.|Day 2 to Week 4|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug).||units on a scale||Standard Deviation|Mean
649151|NCT02090413|Primary|Percentage of Participants Reporting Overall Flushing Events During the First 4 Weeks of Treatment, as Assessed by the Modified Flushing Severity Scale (MFSS)|Participant-reported flushing events during the first 4 weeks of treatment recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).|Day 1 to Week 4|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug).||percentage of participants|||Number
649152|NCT02090413|Primary|Percentage of Participants Reporting Overall Flushing Events During the First 4 Weeks of Treatment, as Assessed by the Modified Global Flushing Severity Scale (MGFSS)|Participant-reported flushing events during the first 4 weeks treatment, recorded on the hand-held participant reporting device (eDiary) as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). Day 1 data are not included in the analysis because MGFSS question refers to last 24 hours flushing score.|Day 2 to Week 4|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug); n=number of participants evaluable at given time point.||percentage of participants|||Number
649153|NCT02090088|Secondary|Number of Participants With Adverse Events||Throughout pregnancy and for up to 6 weeks after delivery|All enrolled participants||participants|||Number
649154|NCT02090088|Secondary|Number of Infants With Adverse Events|In the first year of life, the incidence of all serious adverse events, as well as of nevi (birthmarks) and angiomata (benign tumors with blood vessels or lymph vessels), among infants whose mothers received Nplate® therapy at any time during the pregnancy.|12 months from birth|Children born to enrolled participants during the study||infants|||Number
649155|NCT02090088|Secondary|Number of Children Born With Intrauterine Growth Restriction|Number of children born with intrauterine growth restriction (weight, length or head circumference less than tenth percentile for sex and gestational age) among mothers who have received Nplate® therapy at any time during the pregnancy.|At birth|Children born to enrolled participants during the study||children|||Number
649156|NCT02090088|Secondary|Number of Children With Preterm Birth or Low Birth Weight|Number of children with preterm birth (<37 weeks gestation) or low birth weight (<2,500 grams) among children born to mothers who have received Nplate® therapy at any time during the pregnancy.|At birth|Children born to enrolled participants during the study||children|||Number
649157|NCT02090088|Secondary|Number of Participants With Spontaneous and Elective Abortions or Stillbirths|Number of each of spontaneous abortions, elective abortions, and stillbirths among mothers who received Nplate® therapy at any time during the pregnancy.|9 months (during pregnancy)|All enrolled participants||participants|||Number
649158|NCT02090088|Secondary|Number of Children Born With a Specific Pattern of Minor Birth Defects|Only those infants who have received medical evaluation and who have three or more minor defects will be considered “affected” for purposes of the evaluation of a pattern of minor defects.|At birth|Children born with 3 or more minor birth defects|||||
649246|NCT02084797|Other Pre-specified|Core Temperature|Measurement of core temperature using an ingestible CorTemp sensor during the V2R antagonist, agonist and placebo trials will allow researchers to assess if fluid homeostasis and thermoregulation were intertwined in response to each pharmacological intervention.|4 trials (4 weeks)||||||
649159|NCT02090088|Secondary|Number of Children Born With Any 3 or More Minor Birth Defects|An external, independent Congenital Malformation Adjudication Panel (CMAP) comprised of two clinical dysmorphologists and/or teratologists organized malformations based upon organ system and embryology, and determined whether structural defects were major or minor according to a modification of the Metropolitan Atlanta Congenital Defects Program (MACDP) birth defect classification system. A minor structural defect is defined as a defect which occurs in less than 4% of the population but which has neither cosmetic nor functional significance to the child (eg, complete 2,3 syndactyly of the toes).|At birth|Children born to enrolled participants during the study||children|||Number
649160|NCT02090088|Primary|Number of Children Born With Major Birth Defects|An external, independent Congenital Malformation Adjudication Panel (CMAP) comprised of two clinical dysmorphologists and/or teratologists organized malformations based upon organ system and embryology, and determined whether structural defects were major or minor according to a modification of the Metropolitan Atlanta Congenital Defects Program (MACDP) birth defect classification system. A major structural defect is defined as a defect which has either cosmetic or functional significance to the child (eg, a cleft lip), require surgery, or are life-limiting).|At birth|Children born to enrolled participants during the study||children|||Number
649161|NCT02089737|Secondary|Overall Survival|Overall survival was defined as the time to death from the start of panitumumab administration was tabulated.|Up to Week 42 or death (whichever occurred first)|All participants that received panitumumab monotherapy as a third-line or later therapy.||weeks||95% Confidence Interval|Median
649162|NCT02089737|Secondary|Progression-free Survival|Progression-free Survival (PFS) was defined as the time from the first day of study treatment to documented disease progression or death on study. For participants who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate PFS.|Up to Week 42 or death (whichever occurred first)|Participants who were included in the efficacy analysis set and received panitumumab monotherapy as a third-line or later therapy.||Months||95% Confidence Interval|Median
649163|NCT02089737|Primary|Number of Participants With Adverse Drug Reactions|The number of participants with adverse drug reactions reported during the observation period were tabulated by type, seriousness, and time of onset. . Adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug to the last dose of study drug.|Baseline through Week 42|Of the 3086 participants who completed the survey form, 3085 participants were included in the safety analysis set after excluding 1 participant for whom information regarding panitumumab treatment and adverse events were missing.||Participants|||Number
649164|NCT02089347|Secondary|Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Single Booster Dose of SP306 or DT Vaccine|Solicited injection-site: Pain, Erythema, Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3 injection-site: Pain Significant, prevents daily activity; Erythema and Swelling >100 mm. Grade 3 systemic reactions: Fever, >39˚C; Headache, Malaise, and Myalgia, Significant, prevents daily activity.|Day 0 up to Day 7 post-vaccination|Solicited injection-site reactions and systemic reactions were assessed in the Safety Analysis Set.||Percentage of Participants|||Number
649165|NCT02089347|Secondary|Geometric Mean Concentration of Pertussis Antibodies Before and Following Vaccination With Either SP306 or DT Vaccine|Pertussis antitoxin concentration were assayed by the enzyme-linked immunosorbent assay (ELISA) method|Day 0 (pre-vaccination) and Day 28 post-vaccination|Geometric Mean Concentration was assessed in the per-protocol population||Titers||95% Confidence Interval|Geometric Mean
649166|NCT02089347|Secondary|Percentage of Participants With Pertussis (Pertactin and Fimbriae Types 2 and 3) Booster Response Following Vaccination With Either SP306 or DT Vaccine|"Pertussis booster response was defined as a pre-vaccination antibody concentration less than the lower limit of quantitation (LLOQ) and a post-vaccination level ≥ 4XLLOQ; or a pre-vaccination antibody concentration ≥ LLOQ but < 4XLLOQ and a 4-fold rise (i.e. post/pre-vaccination ≥ 4); or a pre-vaccination antibody concentrations ≥ 4XLLOQ and a 2-fold rise (i.e. post/pre-vaccination ≥2).
Pertussis antitoxin concentration were assayed by the enzyme-linked immunosorbent assay (ELISA) method."|Day 28 post-vaccination|Post-vaccination pertussis booster response was determined in the per-protocol population||Percentage of Participants|||Number
649167|NCT02089347|Secondary|Geometric Mean Concentration of Diphtheria and Tetanus Antibodies Before and Following Vaccination With Either SP306 or DT Vaccine|Diphtheria antitoxin concentration was assayed by the toxin neutralization test; Tetanus antitoxin concentration was assayed by the enzyme-linked immunosorbent assay (ELISA) method|Day 0 (pre-vaccination) and Day 28 post-vaccination|Geometric Mean Concentration were assessed in the per-protocol population||Titers||95% Confidence Interval|Geometric Mean
649168|NCT02089347|Secondary|Percentage of Participants With Seroprotection to Diphtheria and Tetanus Antigens Before and Following Vaccination With Either SP306 or DT Vaccine|"Seroprotection was defined as the proportion of participants with diphtheria and tetanus antitoxin concentration level ≥ 0.01 IU/mL.
Diphtheria antitoxin concentration was assayed by the toxin neutralization test; Tetanus antitoxin concentration was assayed by the enzyme-linked immunosorbent assay (ELISA) method."|Day 0 (pre-vaccination) and Day 28 post-vaccination|Seroprotection was assessed in the per-protocol population||Percentage of Participants|||Number
649169|NCT02089347|Secondary|Percentage of Participation With Seroprotection to Diphtheria and Tetanus Antigens Before Vaccination With Either SP306 or DT Vaccine|"Seroprotection was defined as the proportion of participants with pre-vaccination with diphtheria and tetanus antitoxin concentration ≥ 0.1 IU/mL.
Diphtheria antitoxin concentration was assayed by the toxin neutralization test; Tetanus antitoxin concentration was assayed by the enzyme-linked immunosorbent assay (ELISA) method."|Pre-vaccination (Day 0)|Seroprotection was assessed in the per-protocol population||Percentage of Participants|||Number
649170|NCT02089347|Primary|Percentage of Participants With Pertussis Booster Response Following Vaccination With Either SP306 or DT Vaccine|"Pertussis booster response was defined as a pre-vaccination antibody concentration less than the lower limit of quantitation (LLOQ) and a post vaccination level ≥ 4XLLOQ; or a pre-vaccination antibody concentration ≥ LLOQ but < 4XLLOQ and a 4-fold rise (i.e. post/pre-vaccination ≥ 4); or a pre-vaccination antibody concentrations ≥ 4XLLOQ and a 2-fold rise (i.e. post/pre-vaccination ≥2).
Pertussis antitoxin concentration were assayed by the enzyme-linked immunosorbent assay (ELISA) method."|Day 28 post-vaccination|Post-vaccination pertussis booster response was determined in the per-protocol population||Percentage of Participants|||Number
649171|NCT02089347|Primary|Percentage of Participants With Seroprotection to Diphtheria and Tetanus Antigens Post-booster Vaccination With Either SP306 or DT Vaccine|"Seroprotection was defined as the proportion of subjects at 28 days post-vaccination with diphtheria and tetanus antitoxin concentration ≥0.1 IU/mL.
Diphtheria antitoxin concentration was assayed by the toxin neutralization test; Tetanus antitoxin concentration was assayed by the enzyme-linked immunosorbent assay (ELISA) method"|Day 28 post-vaccination|Seroprotection was assessed in the per-protocol population||Percentage of Participants|||Number
649172|NCT02089347|Primary|Percentage of Participants With Diphtheria and Tetanus Post-vaccination Booster Response Following Vaccination With Either SP306 or DT|"Diphtheria booster response was defined as a ≥4-fold rise in pre- to post-vaccination antitoxin concentration in a subject with a pre-vaccination antitoxin concentration ≤ 2.56 IU/mL or a ≥ 2-fold rise in a subject with a pre-vaccination antitoxin concentration >2.56 IU/mL. A tetanus booster response is defined as a ≥ 4-fold rise in pre- to post-vaccination antitoxin concentration in a subject with a pre-vaccination antitoxin concentration ≤ 2.7 IU/mL or a ≥ 2-fold rise in a subject with a pre-vaccination antitoxin concentration >2.7 IU/mL.
Diphtheria antitoxin concentration was assayed by the toxin neutralization test; Tetanus antitoxin concentration was assayed by the enzyme-linked immunosorbent assay (ELISA) method"|Day 28 post-vaccination|Post-vaccination booster response was determined in the per-protocol population||Percentage of Participants|||Number
649173|NCT02089191|Secondary|Mean Speed of Tear Film Break-up at 15 Seconds Post-blink After 12 Hours of Lens Wear|The participant blinked twice, then kept eye open. Circular images were projected onto tear film layer located on the surface of the contact lens. Measuring software automatically detected areas where the tear film destabilized after the blink. The slope of the regression line (distorted areas vs. time) was calculated. A slower speed (higher number) indicates a more stable tear film. The right eye was evaluated.|Hour 12|This analysis population includes all randomized subjects who did not meet the critical deviation criteria as specified in the Deviations and Evaluability Plan.||percent distortion per second||Standard Deviation|Mean
649174|NCT02089191|Primary|Mean Time Post-blink to 15% Distortion of the Projected Rings After 12 Hours of Lens Wear|The participant blinked twice, then kept eye open. Circular images were projected onto tear film layer located on the surface of the contact lens. Measuring software automatically detected areas where the tear film destabilized after the blink. The time to 15% destabilization of the tear film was calculated. A longer time indicates a more stable tear film. The right eye was evaluated.|Day 1, Hour 12, each period|This analysis population includes all randomized subjects who did not meet the critical deviation criteria as specified in the Deviations and Evaluability Plan.||seconds||Standard Deviation|Mean
649175|NCT02089113|Primary|Absence of Cells in Anterior Chamber of the Study Eye||Day 14|||percentage of participants|||Number
649176|NCT02088957|Secondary|Time to First Onset of Seizure Cessation Relative to the Start of the First Acute Intravenous (iv) Administration|Seizure cessation is based on cEEG/vEEG (continuous video electroencephalogram) monitoring.|From start of first acute iv administration|This variable was not analyzed and no results are available.|||||
649177|NCT02088957|Secondary|Percentage of Subjects Requiring a Second Acute Intravenous (iv) Administration Between 15 Minutes to 12 Hours After First Acute iv Administration||Between 15 minutes to 12 hours after first acute iv administration|This variable was not analyzed and no results are available.|||||
649178|NCT02088957|Secondary|Time to Achievement of 12 Hours of Seizure Freedom Relative to the Start of the Last Acute Intravenous (iv) Administration That Occurred Prior to the Initiation of Bid (Twice a Day) Dosing|Seizure freedom is based on cEEG/vEEG (continuous video electroencephalogram) monitoring.|From start of last acute iv administration prior to initiation of bid dosing (which begins 12 hours after the last acute iv administration of study drug)|This variable was not analyzed and no results are available.|||||
649179|NCT02088957|Secondary|Time to Achievement of 12 Hours of Seizure Freedom Relative to the Start of the First Acute Intravenous (iv) Administration|Seizure freedom is based on cEEG/vEEG (continuous video electroencephalogram) monitoring.|From start of first acute iv administration on Day 1|This variable was not analyzed and no results are available.|||||
649180|NCT02088957|Secondary|Percentage of Subjects With Seizure Freedom for 12 Hours Based on cEEG/vEEG Monitoring Which Starts After the End of the Last Acute Intravenous (iv) Administration of Study Drug and Prior to the Initiation of Bid (Twice a Day) Dosing|Seizure freedom is based on cEEG/vEEG (continuous video electroencephalogram) monitoring.|From end of the last acute iv administration of study drug and prior to initiation of bid dosing (which begins 12 hours after the last acute iv administration of study drug)|This variable was not analyzed and no results are available.|||||
649181|NCT02088957|Primary|Percentage of Subjects With Seizure Freedom for 12 Hours Based on cEEG/vEEG Monitoring Which Starts 1 Hour After the End of the Last Acute iv Administration of Study Drug and Prior to the Initiation of Bid (Twice a Day) Dosing|Seizure freedom is based on cEEG/vEEG (continuous video electroencephalogram) monitoring.|From 1 hour after end of the last acute iv administration of study drug and prior to initiation of bid dosing (which begins 12 hours after the last acute iv administration of study drug)|This variable was not analyzed and no results are available.|||||
649182|NCT02088177|Primary|Number of Participants Receiving the Second Injection of Study Medication|The number of participants who accept the second injection at week 5 will be used as one measure of tolerability.|Weeks 1 - 5|||Participants|||Count of Participants
649183|NCT02088177|Primary|Change in Marijuana Use|Change in marijuana use, as measured by comparing the mean number of self reported days of marijuana use per week in the final study week, which will be week 8 or earlier if the participant discontinues as compared to the mean number of self reported days of marijuana use in week 1|Weeks 1 - 8|||days||Standard Deviation|Mean
649184|NCT02087995|Primary|The Percentage of Agreement of the Continuous Glucose Monitoring System Glucose Values Comparing to a Laboratory Reference, Yellow Sprint Instrument (YSI) Measurement.|The percentage of CGM system values that are within 20% of the reference value for YSI glucose levels > 80 mg/dL or within 20 mg/dL at the reference glucose levels < 80 mg/dL.|7-day wear period|For the demographic and other baseline characteristic information, data from all 51 enrolled subjects was summarized.||Units analyzed% matched pairs w/i %20/20|||Number
649247|NCT02084797|Other Pre-specified|Body Weight|Changes in body weight during the V2R antagonist, agonist and placebo conditions will provide researchers with an additional measure of overall fluid balance (fluid in versus fluid out) as well as an estimate of overall sweat water losses.|4 trials (4 weeks)||||||
649185|NCT02087943|Secondary|Number of Participants With TEAEs During the Apremilast Exposure Period|A TEAE is an adverse event with a start date on or after the date of the first dose of investigational product (IP) and no later than 28 days after the last dose of IP. An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a pre existing condition) should be considered an AE. A serious AE is any which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect; constitutes an important medical event.|Baseline to Week 24; median duration of apremilast 30 mg was 23.3 weeks and 22.4 weeks for apremilast 40 mg|Safety population includes all participants who received at least one dose of IP. These were Apremilast participants as treated.||participants|||Number
649186|NCT02087943|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Placebo Controlled Period|A TEAE is an adverse event with a start date on or after the date of the first dose of IP and no later than 28 days after the last dose of IP for participants who discontinued early. An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a pre existing condition) should be considered an AE. A serious AE is any which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect; constitutes an important medical event.|Baseline to Week 12|Safety population includes all participants who received at least one dose of IP.||participants|||Number
649187|NCT02087943|Secondary|The Percentage Change From Baseline in the Average Weekly Pruritus Numerical Rating Scale (NRS) Score at Week 4|The participant completed a daily diary recording the average intensity of pruritus they experienced during the preceding 24 hrs. The intensity of pruritus was assessed using a validated 11-point NRS, ranging from 0 (“no pruritus”) to 10 (“the worst pruritus imaginable”). It should be noted that this NRS is distinct from the pruritus, Visual Analogue Scale (VAS) in the Modified SCORAD Index with respect to recall period (three days for the VAS). The weekly NRS score was calculated as the average of the NRS scores over 7 days within the specified week. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.|Baseline to Week 4|All participants who were randomized as specified in the protocol and who received at least one dose of IP with a baseline and at least 1 postbaseline value at or before Week 4 were included. LOCF.||percent change||Standard Error|Least Squares Mean
649188|NCT02087943|Secondary|Percentage of Participants Who Achieved at Least a 50% Reduction From Baseline in the EASI Score (EASI 50) at Week 12|The EASI 50 reduction (defined as ≥ 50% reduction from baseline in EASI score) was selected to serve as the key responder endpoint. A ≥ 50% improvement is clinically meaningful for this population.|Baseline to Week 12|ITT includes all participants who were randomized as specified in the protocol and received at least one dose of IP. LOCF.||percentage of participants|||Number
649189|NCT02087943|Secondary|Percentage of Participants Who Achieved a Score of 0 (Cleared) or 1 (Almost Cleared) and at Least a 2-point Reduction From Baseline in a Static Physician’s Global Assessment of Acute Signs (sPGA-A) at Week 12.|The sPGA-A is intended to assess the global severities (ie, a “visual average” integrating all areas of AD) of key acute clinical signs of AD, including erythema, induration/papulation, oozing/crusting (lichenification excluded) based on a 5-point scale of cleared (0), almost cleared (1), mild (2), moderate (3) and severe (4).|Baseline to Week 12|ITT includes all participants who were randomized as specified per protocol and received at least one dose of IP. LOCF for missing data handling.||percentage of participants|||Number
649190|NCT02087943|Primary|Percentage Change From Baseline in the Eczema Area and Severity Index (EASI) Score at Week 12.|EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). A representative lesion is selected for each of the four body regions for assessing the intensity of each of the four signs (erythema, induration /papulation, excoriation, and lichenification). Symptoms (eg, pruritus) and secondary signs (eg, xerosis, scaling) are excluded from the assessment. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.|Baseline to Week 12|All participants who were randomized as specified per protocol and who received at least one dose of IP with a baseline and at least 1 post baseline value at or before week 12; A missing value at Week 12 was imputed by last observation carried forward (LOCF), including the value obtained at the Early Termination Visit prior to Week 12.||percent change||Standard Error|Least Squares Mean
649191|NCT02087774|Primary|Change From Baseline to After Intervention for After-Exercise Heart Rate|"Immediate cool-down, after-exercise heart rate was taken.
Difference in heart rate from baseline measurements is reported"|Baseline to 12 weeks later|||beats per minute||95% Confidence Interval|Mean
649192|NCT02087774|Primary|Change From Baseline to After Intervention in 75 Foot Laps Completed in 2 Minutes|"Subjects run for 2 minutes around cone separated by 75ft. One lap was one 75 foot length completed.
Difference in laps completed from baseline was taken."|Baseline to 12 weeks later|||Difference in Laps Completed||95% Confidence Interval|Mean
649193|NCT02087748|Secondary|Mean Reduction in SPID Scores of DOMS While Standing Over 24 Hours|"The secondary outcome is the mean reduction in DOMS scores while standing in the leg receiving Topical Voltaren® gel versus the leg receiving placebo over the first 24 hours post treatment initiation.
Pain intensity was assessed at predefined time points (at Predose, 3, 9, 15, 21, and 24 hours after first drug administration) using an 11-point Numeric Rating Scale (NPRS) where a score of zero indicates no pain and a score of ten indicates pain as bad as you can imagine. Pain Intensity Differences at each predefined time point (calculated as post-baseline NPRS values - baseline NPRS values) were analyzed. The theoretical maximum range of Sum of pain intensity differences (SPID24) is from -50 (indicative of an increase in pain) to 50 (indicative of a decrease in pain)."|7 days|||units on a scale||Standard Deviation|Mean
660901|NCT01849770|Secondary|Mean Pain Severity - Ratios for Comparisons of Doses for Weeks 3-12||Week 3-12, post titration of study medication|||ratio||95% Confidence Interval|Number
649194|NCT02087748|Secondary|Mean Reduction in SPID Scores of DOMS at Rest Over 24 Hours|"The secondary outcome is the mean reduction in DOMS scores at rest in the leg receiving Topical Voltaren® gel versus the leg receiving placebo over the first 24 hours post treatment initiation.
Pain intensity was assessed at predefined time points (at Predose, 3, 9, 15, 21, and 24 hours after first drug administration) using an 11-point Numeric Rating Scale (NPRS) where a score of zero indicates no pain and a score of 10 indicates pain as bad as you can imagine. Pain Intensity Differences at each predefined time point (calculated as post-baseline NPRS values - baseline NPRS values) were analyzed. The theoretical maximum range of Sum of pain intensity differences (SPID24) is from -50 (indicative of an increase in pain) to 50 (indicative of a decrease in pain)."|7 days|||units on a scale||Standard Deviation|Mean
649195|NCT02087748|Primary|Mean Reduction in SPID Scores of DOMS on Walking Over 24 Hours|"The primary outcome is the analgesic efficacy of Topical Voltaren® gel compared to placebo in the reduction of the pain associated with DOMS. The statistical comparison of interest will be the mean reduction in DOMS scores upon walking in the leg receiving Topical Voltaren® gel vs the leg receiving placebo over the first 24 hours post treatment. Pain intensity was assessed at predefined time points (Predose, 3, 9, 15, 21, and 24 hours after first drug administration) using an 11-point Numeric Rating Scale (NPRS) where a score of zero indicates no pain and 10 indicates pain as bad as you can imagine. Pain Intensity Differences at each predefined time point (calculated as post-baseline NPRS values - baseline NPRS values) were analyzed. The theoretical maximum range of Sum of pain intensity differences (SPID24) is from -50 (indicative of an increase in pain) to 50 (indicative of a decrease in pain)."|7 days|||units on a scale||Standard Deviation|Mean
649196|NCT02087670|Secondary|Oxygen Consumption||8 weeks|||ml/min||Standard Deviation|Mean
649197|NCT02087670|Primary|Natriuretic Brain Pro-peptid||8 weeks|||pg/ml||Full Range|Median
649198|NCT02087241|Secondary|Assess Overall Survival in Each Treatment Arm|Overall survival is defined as the time from the date of randomization until death due to any cause.|Up to a maximum of 4 treatment cycles (treatment cycles will be repeated every 21 days)|Overall Survival (OS) data were not collected.|||||
649199|NCT02087241|Secondary|Assess the Duration of Response in Each Treatment Arm|Duration of response is defined as the time from the date of first documented response until the date of documented progression or any cause death.|Up to a maximum of 4 treatment cycles (treatment cycles will be repeated every 21 days)|Duration of response data were not collected.|||||
649200|NCT02087241|Secondary|Assess the Disease Control Rate in Each Treatment Arm|the disease control rate is defined as the percentage of FAS subjects with a best overall response of CR, PR or SD).|Up to a maximum of 4 treatment cycles (treatment cycles will be repeated every 21 days)|||Percentage of Participants||90% Confidence Interval|Number
649201|NCT02087241|Secondary|Assess the Objective Response Rates in Each Arm|The objective response rate is defined as the number of the subjects with a confirmed best overall response of CR or PR divided by the number of subjects in the Full Analysis Set (FAS) for whom measureable disease is present at baseline|Up to a maximum of 4 treatment cycles (treatment cycles will be repeated every 21 days)|||Percentage of Participants||90% Confidence Interval|Number
649202|NCT02087241|Primary|Progression Free Survival|Progression free survival is defined as the time from randomisation until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the subject withdraws from randomised therapy or receives another anti-cancer therapy prior to progression.|6 months|Progression-Free Survival data were not collected.|||||
649203|NCT02087176|Primary|Objective Response Rate|Response evaluation is determined by using Response Evaluation Criteria in Solid Tumours (RECIST v1.1) for target lesions assessed by medical imaging scan (e.g. CT or MRI). The same method of assessment and the same technique was to be used to characterize each identified and reported lesion at baseline and during subsequent imaging procedures. The objective response rate is defined as the percentage of patients with a confirmed best overall response of Complete Response (CR) or Partial Response (PR). Complete Response is defined as disappearance of all target lesions since baseline. Any pathological lymph nodes selected as target lesions must have a reduction in short axis to < 10 mm. Partial Response is defined as at least a 30% decrease in the sum of the diameters of the Target Lesion, taking as reference the baseline sum of diameters.|Up to 20 months|Thirty-two (32) subjects were enrolled in Part A, but the study was terminated early. Patients on-study at the time the study was terminated have been censored.||Percentage of Participants||90% Confidence Interval|Number
649204|NCT02087176|Secondary|Pharmacokinetic Profile of AZD 1775 in Combination With Docetaxel|Venous blood samples taken for determination of AZD1775, metabolites of 1775 on Cycle 1, Day 1 pre-dose and 2 hours post dose, Cycle 2 Day 1 pre-dose and 2 hours post dose, and Cycle 4 pre-dose and 2 hours post dose. However, the study was terminated early by the sponsor; therefore, pharmacokinetic data were not collected.|Up to projected 20 months, subjects will be restaged after every 2 cycles (every 6 weeks.) continue until disease progression or unacceptable toxicity|The study was terminated early by the sponsor. Pharmacokinetic data have not been analyzed.|||||
649205|NCT02087059|Secondary|Summary of Summary of EORTC QLQ-C30 Responses by Time|The QLQ-C30 version 1.0 (QLQ-C30) incorporates five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), a global health status / QoL scale, and a number of single items assessing additional symptoms commonly reported by cancer patients (dyspnoea, loss of appetite, insomnia, constipation and diarrhea) and perceived financial impact of the disease.All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.|24 weeks|FAS||units on a scale||Standard Deviation|Mean
649206|NCT02087059|Secondary|Summary of Total Symptom Score as Measured by Seven-day Modified Myelofibrosis Symptom Assessment Form (MFSAF) v2.0 by Time|The modified MFSAF v2.0 diary captures a patient's symptom severity on a scale of 0 (absent) to 10 (worst imaginable),with a maximal summary score of 60|24 weeks|||score on a scale||Standard Deviation|Mean
649207|NCT02087059|Secondary|Charge in Spleen Size From Baseline up to the Specified Week|Number of patients with spleen length reduced by ≥ 50% up to specified week|Baseline, 24 weeks|||particiapants|||Number
649208|NCT02087059|Secondary|Charge in Spleen Size From Baseline at Specified Week|Number of patients with spleen length reduced by ≥ 50% at specified week|Baseline, 24 weeks|||particiapants|||Number
649210|NCT02086786|Other Pre-specified|Positive and Negative Syndrome Scale (PANSS) Total Score|"The change in PANSS score from Baseline by visit 48.
The PANSS combines 3 subscales: The positive scale (7 items), the negative scale (7 items) and the general psychopathology scale (16 items).
PANSS Items Scores: 1 = Absent, 2 = Minimal, 3 = Mild, 4 = Moderate, 5 = Moderate Severe, 6 = Severe, 7 = Extreme.
Subscales are summed to compute a total score Range for each of the subscales: Positive scale (7-49); Negative scale (7-49); General psychopathology scale (16-112) Range for the PANSS total scale: 30-210 PANSS total score ≤70: stable schizophrenia PANSS total score between >70: decompensated schizophrenia"|Baseline, Days 5, 7, 10, 14, 18, and 21 post Dose 1; Dose 2, 3 and 4 post dose; Days 5, 7, 10, 14, 18, and 21 post Dose 2, 3, and 4; Days 25, 28, 32, 37, 42, 60, 75, 90, and 105 post Dose 4; Day 120 post Dose 4 or early termination.|The analysis was conduct in the Intent-to-Treat (ITT) Population, which includes all patients in Safety Population with baseline (Day -1) efficacy data and at least 1 post-baseline efficacy evaluation. ITT Population includes 66 patients; 33 on each arm.||points||Standard Deviation|Mean
649211|NCT02086786|Secondary|Accumulation Ratio (RA) for Active Moiety|Defined as AUC (0-28 days) after the 4th dose divided by the AUC (0-28 days) of the first dose.|Dose 1, 2 and 3: Pre-dose; at 2, 8, 12, 24 and 48 hours post-dose; 5, 7, 10, 14, 18, and 21 days post-dose. Dose 4: Pre dose; at 2, 8, 12, 24, and 48 hours post-dose; at 5, 7, 10, 14, 18, 21, 25, 28, 32, 37, 42, 60, 75, 90, 105, and 120 days post-dose.|The analysis was conducted in the PK population (patients who had at least 1 PK sample taken and had no major protocol deviations that would exclude them from PK analysis). As determined by the pharmacokineticist, for this analysis, 18 patients in the gluteal and 22 in the deltoid group had concentration amenable to evaluation.||Ratio||Geometric Coefficient of Variation|Geometric Mean
649212|NCT02086786|Primary|PTF for Active Moiety|Peak to Trough Fluctuation ratio for the Active Moiety|Dose 1, 2 and 3: Pre-dose; at 2, 8, 12, 24 and 48 hours post-dose; 5, 7, 10, 14, 18, and 21 days post-dose. Dose 4: Pre dose; at 2, 8, 12, 24, and 48 hours post-dose; at 5, 7, 10, 14, 18, 21, 25, 28, 32, 37, 42, 60, 75, 90, 105, and 120 days post-dose.|The analysis was conduct in the PK population, which includes 43 patients (20 in the gluteal and 23 in the deltoid site injection group) who had at least 1 PK sample taken and had no major protocol deviations that would exclude them from PK analysis. They also had concentration data amenable to evaluation as determined by the pharmacokineticist.||Ratio||Geometric Coefficient of Variation|Geometric Mean
649213|NCT02086786|Primary|Terminal Half-life (t1/2) for Active Moiety||Dose 1, 2 and 3: Pre-dose; at 2, 8, 12, 24 and 48 hours post-dose; 5, 7, 10, 14, 18, and 21 days post-dose. Dose 4: Pre dose; at 2, 8, 12, 24, and 48 hours post-dose; at 5, 7, 10, 14, 18, 21, 25, 28, 32, 37, 42, 60, 75, 90, 105, and 120 days post-dose.|The analysis was conducted in the PK population (patients who had at least 1 PK sample taken and had no major protocol deviations that would exclude them from PK analysis). As determined by the pharmacokineticist, for this analysis, 12 patients in the gluteal and 19 in the deltoid group had concentration amenable to evaluation.||h||Geometric Coefficient of Variation|Geometric Mean
649214|NCT02086786|Primary|Time to Peak Concentration (Tmax) for Active Moiety||Dose 1, 2 and 3: Pre-dose; at 2, 8, 12, 24 and 48 hours post-dose; 5, 7, 10, 14, 18, and 21 days post-dose. Dose 4: Pre dose; at 2, 8, 12, 24, and 48 hours post-dose; at 5, 7, 10, 14, 18, 21, 25, 28, 32, 37, 42, 60, 75, 90, 105, and 120 days post-dose.|The analysis was conducted in the PK population, which includes 43 patients (20 in the gluteal and 23 in the deltoid site injection group) who had at least 1 PK sample taken and had no major protocol deviations that would exclude them from PK analysis. They also had concentration data amenable to evaluation as determined by the pharmacokineticist.||h||Full Range|Median
649215|NCT02086786|Primary|AUCτ for Active Moiety|AUCτ is the area under the curve over the dosing interval (τ), where the dosing interval is 28 days|Dose 1, 2 and 3: Pre-dose; at 2, 8, 12, 24 and 48 hours post-dose; 5, 7, 10, 14, 18, and 21 days post-dose. Dose 4: Pre dose; at 2, 8, 12, 24, and 48 hours post-dose; at 5, 7, 10, 14, 18, 21, 25, 28, 32, 37, 42, 60, 75, 90, 105, and 120 days post-dose.|The analysis was conducted in the PK population: 43 patients (20 in the gluteal and 23 in the deltoid site injection group). As determined by the pharmacokineticist, for Dose 4th analysis, 18 patients in the gluteal and 22 in the deltoid group had concentration amenable to evaluation.||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
649216|NCT02086786|Primary|Area Under the Curve Extrapolated to Infinity (AUC∞) for Active Moiety||Dose 1, 2 and 3: Pre-dose; at 2, 8, 12, 24 and 48 hours post-dose; 5, 7, 10, 14, 18, and 21 days post-dose. Dose 4: Pre dose; at 2, 8, 12, 24, and 48 hours post-dose; at 5, 7, 10, 14, 18, 21, 25, 28, 32, 37, 42, 60, 75, 90, 105, and 120 days post-dose.|The analysis was conducted in the PK population (patients who had at least 1 PK sample taken and had no major protocol deviations that would exclude them from PK analysis). As determined by the pharmacokineticist, for this analysis, 11 patients in the gluteal and 18 in the deltoids had concentration amenable to evaluation.||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
649217|NCT02086786|Primary|Area Under the Curve to the Last Quantified Concentration (AUClast) for Active Moiety||Dose 1, 2 and 3: Pre-dose; at 2, 8, 12, 24 and 48 hours post-dose; 5, 7, 10, 14, 18, and 21 days post-dose. Dose 4: Pre dose; at 2, 8, 12, 24, and 48 hours post-dose; at 5, 7, 10, 14, 18, 21, 25, 28, 32, 37, 42, 60, 75, 90, 105, and 120 days post-dose.|The analysis was conducted in the PK population (patients who had at least 1 PK sample taken and had no major protocol deviations that would exclude them from PK analysis). As determined by the pharmacokineticist, for this analysis, 18 patients in the gluteal and 22 in the deltoids had concentration amenable to evaluation..||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
649218|NCT02086786|Primary|Trough Plasma Concentration (Cmin) for Active Moiety||Dose 1, 2 and 3: Pre-dose; at 2, 8, 12, 24 and 48 hours post-dose; 5, 7, 10, 14, 18, and 21 days post-dose. Dose 4: Pre dose; at 2, 8, 12, 24, and 48 hours post-dose; at 5, 7, 10, 14, 18, 21, 25, 28, 32, 37, 42, 60, 75, 90, 105, and 120 days post-dose.|The analysis was conducted in the PK population, which includes 43 patients (20 in the gluteal and 23 in the deltoid site injection group) who had at least 1 PK sample taken and had no major protocol deviations that would exclude them from PK analysis. They also had concentration data amenable to evaluation as determined by the pharmacokineticist.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
649248|NCT02084797|Secondary|Saliva Sodium Concentration|Measurement of salivary sodium concentration will allow us to determine if the V2R antagonist, agonist and placebo interventions activate aquaporin-5 (AQP5) water channels that are also located in sweat glands. If the V2R acts on the sweat glands through AQP5, there should be parallel changes in sweat, urine and saliva sodium concentrations with each pharmaceutical intervention.|4 trials (4 weeks)|||mEq/L||Standard Deviation|Mean
649219|NCT02086786|Primary|Peak Plasma Concentration (Cmax) for Active Moiety||Dose 1, 2 and 3: Pre-dose; at 2, 8, 12, 24 and 48 hours post-dose; 5, 7, 10, 14, 18, and 21 days post-dose. Dose 4: Pre dose; at 2, 8, 12, 24, and 48 hours post-dose; at 5, 7, 10, 14, 18, 21, 25, 28, 32, 37, 42, 60, 75, 90, 105, and 120 days post-dose.|The analysis was conducted in the PK population, which includes 43 patients (20 in the gluteal and 23 in the deltoid site injection group) who had at least 1 PK sample taken and had no major protocol deviations that would exclude them from PK analysis. They also had concentration data amenable to evaluation as determined by the pharmacokineticist.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
649220|NCT02086708|Primary|Measure Liver Elasticity Value Using Sonoelastography.|Assess liver stiffness as measured by sonoelastography with results of liver biopsy as read by a single-pathologist using the METAVIR criteria (F0-F4).|Day one|||kPa||95% Confidence Interval|Mean
649221|NCT02086591|Other Pre-specified|Exploratory Objective|To investigate change in plasma matrix metalloproteinase 9 (MMP9) levels as a biomarker of treatment response; to assess plasma matrix metalloproteinase 9 (MMP9) expression by immunohistochemistry (IHC) and correlate to response in order to test the hypothesis that elevated intratumoral levels of plasma matrix metalloproteinase 9 (MMP9) can predict response to doxycycline. To assess activation/expression of nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kb) and Signal transducer and activator of transcription 3 (STAT 3) pathways in archived tumor by immunohistochemistry (IHC) to predict response or resistance to doxycycline.|One year|No data displayed because Outcome Measure has zero total participants analyzed|||||
649222|NCT02086591|Secondary|Percentage of Patients With Progression Free Survival|Progression free survival is defined as the percentage of patients with stable disease or no death. Stable disease is defined as less than a partial response but is not progressive disease. Partial Response (PR)-At least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses as determined byFDG-PET for CT scan. No increase should be observed in the size of other nodes, liver, or spleen. Patients who achieve a CR by the above criteria, but who have persistent morphologic bone marrow involvement will be considered partial responders. When the bone marrow was involved before therapy and a clinical CR was achieved, but with no bone marrow assessment after treatment, patients should be considered partial responders.|One year|Data was collected on all patients who were enrolled.||percentage of participants|||Number
649223|NCT02086591|Primary|Overall Response Rate|"Overall response rate is defined as the percentage of patients with disease progression. Progression is defined as:
Appearance of a new lesion on fluorodeoxyglucose (FDG)-positron emission tomography or computerized tomography
≥50% increase in sum of the product of the node dimensions (SPD) of more than one node or in greatest diameter of any previously identified node >1 cm in its short axis from nadir.
To be considered progressive disease, a lymph node with a diameter of the short axis of less than 1.0 cm must increase by 50% and to a size of 1.5 x 1.5 cm or more than 1.5 cm in the long axis.
At least a 50% increase in the longest diameter of any single previously identified node more than 1 cm in its short axis."|Three months|||percentage of participants|||Number
649224|NCT02085785|Secondary|Change in 6-minute Walk Distance|Change in 6-minute walk distance (ft) from baseline to follow-up|Baseline and at follow-up assessment (20-weeks after randomization)|Baseline carried forward if 20-week follow-up data not collected||feet||95% Confidence Interval|Mean
649225|NCT02085785|Secondary|Change in Weight|Changes between baseline and 20-weeks later (end of intervention)|Baseline and follow-up assessment (20-weeks after randomization)|Those who were not assessed at 20 weeks were assumed to have the same values as at baseline (last observation carried forward)||pounds||95% Confidence Interval|Mean
649226|NCT02085785|Secondary|Acceptability|Acceptability of intervention will be assessed via a brief satisfaction survey - % who would recommend the program to a friend|At follow-up assessment (20-weeks follow-up)|Number who reported that they would recommend the program to a friend. Intervention assessment questionnaires were not linked to other study data, so we are unable to report study group information. The number analyzed are those who completed the 20-week follow-up measure.||Participants|||Count of Participants
649227|NCT02085785|Secondary|Feasibility - Retention|Number of randomized individuals who complete baseline and study exit visit|Follow-up assessments (all participants) and during intervention (intervention group only) (weekly, for 20 weeks)|||participants|||Number
649228|NCT02085785|Primary|Number of Individuals That Were Randomized of Those Contacted (Feasibility)|Specific components include yield by method, recruitment rate, refusal rates and reasons|During recruitment (expected duration of 12-15 months)|313 individuals were assessed for this outcome measure. Note that the number analyzed are those that we contacted via a mailing or who contacted the study after seeing a study flyer.||participants|||Number
649229|NCT02085720|Secondary|Sleep and Health Questionnaire Result||1 year|||% of participants|||Number
649230|NCT02085720|Secondary|AHI Result||1 year|||% of participants|||Number
649231|NCT02085720|Secondary|CPAP Compliance Among Chinese Elderly|Elderly subjects who agree for home CPAP treatment are prescribed nasal CPAP units with time clocks to assess objective compliance (run time).|1 year|||hours||Standard Deviation|Mean
649232|NCT02085720|Secondary|Prevalence of Restless Leg Syndrome (RLS)|RLS is a disorder characterized by disagreeable leg sensations that usually occur before sleep onset, causing an almost irresistible urge to move the legs. As minimal criteria for diagnosis, the following four features were required: (1) desire to move the extremities, often associated with paresthesias and/or dysesthesias; (2) motor restlessness; (3) worsening of symptoms at rest, with at least temporary relief by activity; and (4) worsening of symptoms in the evening or at night.|3 years|||% of participants|||Number
649233|NCT02085720|Primary|Prevalence of Obstructive Sleep Apnea Syndrome in Chinese Elderly|Subjects who have completed the questionnaires and consented for sleep study are invited to undergo a portable at-home sleep study (EMBLETTA). It is a multi-channel screening tool that measures airflow through a nasal cannula connected to a pressure transducer, providing an apnea hypopnea index (AHI) based on recording time. AHI is the average number of events per hour while 5-15 events per hour denotes mild OSA, 16-30 events moderate OSA, and >30 events severe OSA. Obstructive sleep apnea syndrome is defined as AHI 15 events or above or AHI being 5 or above pulus ESS 10 or more. This measure is reporting the percentage of participants with OSAS.|3 years|||% of participants|||Number
649446|NCT02081014|Secondary|Glucose Cmax (Fasting)|Pharmacodynamic parameter: Maximum concentration of glucose|Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 180 minutes post-injection|All randomized subjects who received at least one dose of study drug||mg/dl||Standard Error|Mean
649234|NCT02085161|Secondary|Resting Inspiratory Capacity (IC) Measured at 1.5 Hours Post Dose After 8 Weeks of Treatment|Resting inspiratory capacity (IC) measured at 1.5 hours post dose after 8 weeks of treatment.|Week 8|Full analysis set (FAS): This patient set included all patients in the TS who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint. Patients were assigned to the FAS after implementation of any data handling rules that set measurements to missing. Patients with available data were included.||Liter||Standard Error|Least Squares Mean
649235|NCT02085161|Secondary|One Hour, Post-dose Forced Vital Capacity (FVC) After 8 Weeks of Treatment|One hour, Post-dose Forced Vital Capacity (FVC) after 8 weeks of treatment.|Week 8|Full analysis set (FAS): This patient set included all patients in the TS who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint. Patients were assigned to the FAS after implementation of any data handling rules that set measurements to missing. Patients with available data were included.||Liter||Standard Error|Least Squares Mean
649236|NCT02085161|Secondary|One Hour, Post-dose Forced Expiratory Volume in One Second (FEV1) After 8 Weeks of Treatment|One hour, Post-dose Forced Expiratory Volume in One Second (FEV1) after 8 weeks of treatment.|Week 8|Full analysis set (FAS): This patient set included all patients in the TS who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint. Patients were assigned to the FAS after implementation of any data handling rules that set measurements to missing. Patients with available data were included.||Liter||Standard Error|Least Squares Mean
649237|NCT02085161|Secondary|Endurance Time During Endurance Shuttle Walk Test (ESWT) to Symptom Limitation After 12 Weeks|Endurance time during ESWT to symptom limitation at walking speed corresponding to 85% of maximum oxygen consumption (VO2 peak) after 12 weeks of pharmacological treatment and non-pharmacological intervention. The numerical value of endurance time in seconds was transformed in log10 scale to correct for skewness and then the ANCOVA was fitted to the log10-transformed data and the least square means and SE were obtained. To present the results in a way easier for interpretation, the least square mean from the ANCOVA fitted to the log10-transformed data were transformed back taking 10 to the power of the least square estimate to obtain the geometric mean and the corresponding SE was transformed using delta method to get the corresponding SE of the geometric mean.|Week 12|Full analysis set (FAS): This patient set included all patients in the TS who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint. Patients were assigned to the FAS after implementation of any data handling rules that set measurements to missing. Patients with available data were included.||Second||Standard Error|Geometric Mean
649238|NCT02085161|Secondary|Perceived Difficulties as Evaluated With Functional Performance Inventory-Short Form (FPI-SF) Total Score at Week 12|Perceived difficulties as evaluated with FPI-SF. FPI-SF self-report questionnaire has 6 domains: Body care(5 items), Household maintenance(8 items), Physical exercise(5 items), Recreation(5 items), Spiritual activities(4 items) and Social interaction(5 items) with five possible answers on each item: Do with no difficulty - 3, Do with some difficulty - 2, Do with great difficulty - 1, don’t do because of health reasons - 0, and don’t do because choose not to - 0. Domain scores are expressed as mean values, with at least 6 non-missing items required for the household maintenance domain and at least 3 non-missing items for the other domains. Total score is the mean across the six domains. So total and domain scores range from 0 to 3, with higher scores indicating higher levels of functional activity within and across domains. Respondents engaged in many activities with no difficulty will score high on the FPI, while those who perform few activities with much difficulty will score low.|Week 12|Full analysis set (FAS): This patient set included all patients in the TS who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint. Patients were assigned to the FAS after implementation of any data handling rules that set measurements to missing. Patients with available data were included.||Units on a scale||Standard Error|Least Squares Mean
649239|NCT02085161|Secondary|Average Daily Walking Intensity Measured by the Activity Monitor in the Week Prior to 12 Weeks of Treatment|Average daily walking intensity measured by the activity monitor in the week prior to 12 weeks of treatment. The Movement Intensity (MI) is derived from the acceleration signals. Since seismic sensors measure gravitational acceleration (g) in static situations, the acceleration signal is expressed relative to g (1g = 9.81m/s2). To calculate movement intensity (MI) the gravitational acceleration in static situations was removed and the rotation vector of the three accelerometer signals was calculated. The MI gives an indication of the power of movements.|Week 12|Full analysis set (FAS): This patient set included all patients in the TS who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint. Patients were assigned to the FAS after implementation of any data handling rules that set measurements to missing. Patients with available data were included.||Multiple of 9.8*(meters / (second^2))||Standard Error|Least Squares Mean
649240|NCT02085161|Secondary|Average Daily Walking Time Measured by the Activity Monitor in the Week Prior to Week 12|Average daily walking time measured by the activity monitor in the week prior to Week 12.|Week 12|Full analysis set (FAS): This patient set included all patients in the TS who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint. Patients were assigned to the FAS after implementation of any data handling rules that set measurements to missing. Patients with available data were included.||Second||Standard Error|Least Squares Mean
649241|NCT02085161|Primary|Endurance Time During Endurance Shuttle Walk Test (ESWT) to Symptom Limitation After 8 Weeks|Endurance time during ESWT to symptom limitation at walking speed corresponding to 85% of predicted maximum oxygen consumption (VO2 peak) after 8 weeks of pharmacological treatment and non-pharmacological intervention. The numerical value of endurance time in seconds was transformed in log10 scale to correct for skewness and then an analysis of covariance (ANCOVA) was fitted to the log10-transformed data and the least square means (LSMean) and standard error (SE) were obtained. To present the results in a way easier for interpretation, the least square mean from the ANCOVA fitted to the log10-transformed data were transformed back taking 10 to the power of the least square estimate to obtain the geometric mean and the corresponding SE was transformed using delta method to get the corresponding SE of the geometric mean.|Week 8|Full analysis set (FAS): This patient set included all patients in the Treated set (TS) who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint. Patients were assigned to the FAS after implementation of any data handling rules that set measurements to missing. Patients with available data were included.||Second||Standard Error|Geometric Mean
649242|NCT02084797|Other Pre-specified|Fluid Intake|To determine if fluid intake behaviors were appropriately regulated in response to the V2R antagonist, agonist and placebo conditions during exercise.|4 weeks (4 trials)||||||
649249|NCT02084797|Secondary|Blood Sodium Concentration|Measurement of blood sodium concentration will determine if normonatremia (blood sodium concentrations within the normal physiological range of 135-145mmol/L) were maintained throughout the trial with appropriate fluid intake during the V2R antagonist, agonist and placebo intervention trials.|4 study trials (4 weeks)|||mEq/L||Standard Deviation|Mean
649250|NCT02084797|Secondary|Urine Sodium Concentration After the Steady-state Portion of the Trial|Changes in urine sodium concentration after use of the V2R antagonist, agonist and placebo interventions will verify whether or not pharmacologic activation or inhibition was successfully induced.|4 study trials (4 weeks)|||mEq/L||Standard Deviation|Mean
649251|NCT02084797|Primary|Sweat Sodium Concentration Obtained After the Steady-state Portion of the Trial|Changes in sweat sodium concentration will parallel changes in urine sodium concentration with use of the V2R antagonist, agonist and placebo if the primary hypothesis is true (sweat sodium is regulated by the V2R, similar to how urine sodium is regulated by principle cells located within in the kidney collecting duct)|4 study trials (4 weeks)|||mEq/L||Standard Deviation|Mean
649252|NCT02084706|Primary|Difference in Visual-analog Score (VAS) for Anticipated Pain Prior to Injection and Actual Pain After Injection|Members of both study groups completed the Visual Analog Scale (VAS) pain assessment both prior for anticipated pain and after injection for actual pain; these recorded scores were the primary study endpoint and were later compared to determine the difference in anticipated pain versus actual pain experienced. The VAS ranges from 0-10, where 0 is no pain and 10 is worst possible pain. The outcome measure is the mean anticipated pain minus the actual pain experienced.|Our outcome measure was collected within the 60 seconds before and following the steroid injection.|||units on a scale||Standard Deviation|Mean
649253|NCT02084628|Secondary|Diagnostic Confidence for the Pre-contrast and Combined Images Assessed by Yes or no Question|Diagnostic confidence was classified as not confident (No), confident (Yes), very confident (Yes).|Images were taken pre-injection and post-injection (within about 15 minutes)|||number of responses|||Number
649254|NCT02084628|Secondary|Change in Diagnosis for the Combined Images Compared With Precontrast Images|Diagnosis based on the pre-contrast images will be indicated. If there is a change in the diagnosis based on the combined images, then the combined images diagnosis will be recorded.|Images were taken pre-injection and post-injection (within about 15 minutes)|||participants|||Number
649255|NCT02084628|Secondary|Visualization of the Biliary System for the Pre-contrast and Combined Images Assessed by Yes or no Question||Images were taken pre-injection and post-injection (within about 15 minutes)|||participants|||Number
649256|NCT02084628|Secondary|Contrast Enhancement of the Biliary System for the Combined Images Assessed by Yes or no Question|"Biliary system included
Gall bladder
Cystic duct
Common bile duct
Right main bile duct
Left main bile duct"|Images were taken pre-injection and post-injection (within about 15 minutes)|||number of responses|||Number
649257|NCT02084628|Secondary|Contrast Enhancement of the Liver for the Combined Images Assessed by Yes or no Question||Images were taken pre-injection and post-injection (within about 15 minutes)|||number of responses|||Number
649258|NCT02084628|Secondary|Number of Lesions Detected for the Combined Images||Images were taken pre-injection and post-injection (within about 15 minutes)|||number of lesions|||Number
649259|NCT02084628|Secondary|Number of Lesions Detected for the Pre-contrast Images||Images were taken pre-injection|||number of lesions|||Number
649260|NCT02084628|Primary|Number of Subjects With Serious Adverse Events|An serious adverse events (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|From the signing of the informed consent form until the 6 month post MRI follow-up|||participants|||Number
649261|NCT02084628|Primary|Number of Subjects With Adverse Events|An adverse event (AE) was any untoward medical occurrence that is, any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease in a subject or clinical investigation subject after providing written informed consent for participation in the study.|From the signing of the informed consent form until the 6 month post MRI follow-up|||participants|||Number
649262|NCT02084628|Primary|Number of Subjects With Additional Diagnostic Information From Combined (Pre-contrast And Post-contrast) Images Compared With Pre-contrast Images|Additional diagnostic information such as better delineation of the border of the lesion, better definition of the internal morphology of the lesion, better characterization of the lesion, better definition of the location of the lesion, better assessment of the communication of the lesion with respect to the biliary system obtained from the combined magnetic resonance (MR) images compared with pre-contrast MR images. Number of subjects with additional diagnostic information were recorded and analyzed.|Images were taken pre-injection and post-injection (within about 15 minutes)|||participants|||Number
649263|NCT02084238|Secondary|Safety Assessment|Adverse events includes injection site reactions, influenza-like symptoms, infection, fever, tumor, cardiovascular event，drug-induced liver and kidney damage.|up to Day 180||11/2015||||
649264|NCT02084238|Secondary|Number of Relapses|Relapses mean that if the patient's SELENA SLEDAI Score is lower than 4 during the treatment, while the SELENA SLEDAI Score increase after stopping using the study drugs in 3 months.|24 weeks||11/2015||||
649265|NCT02084238|Secondary|SELENA SLEDAI Score|"Assessment version of the SLE Disease Activity Index (SELENA-SLEDAI) change. The higher the score represent the worse of the disease. The total score ranges from 0 to 105 points, score> 8 means the disease is moderate-to-severe active."|week 0, week 10|||score||Standard Deviation|Median
649266|NCT02084238|Secondary|The Immunologic Impact of Low Dose IL-2 Treatment in SLE Patients|Laboratory measures were detected, including, C3, C4 and anti-dsDNA titres.|week 0 and week 10|||g/L||Full Range|Median
649267|NCT02084238|Secondary|Immunological Responses|Analysis regulatory CD4+ T (Treg) cells , interleukin 17 (IL-17)-producing helper T (Th17) cells and follicular helper T (Tfh) cells before and during IL-2 treatment. P values below 0.05 are considered statistically significant in this study.|week 0 and week 10|regulatory CD4+ T (Treg) cells , interleukin 17 (IL-17)-producing helper T (Th17) cells and follicular helper T (Tfh) cells||Percentage of CD4+ T cells||Full Range|Median
649268|NCT02084238|Primary|Number of Participants Who Were SLE Responders (SRI)|SRI response was defined as (1) a ≥ 4-point reduction in SELENA-SLEDAI score, (2) no new BILAG A score or ≤ 1 new BILAG B score, and (3) no deterioration from baseline in the physician's global assessment by ≥ 0.3 points.|week 2，week 4，week 6，week 8，week 10|||paticipants|||Number
649269|NCT02084082|Secondary|AUC0-inf of Metformin in Plasma|"AUC0−inf(area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) for Metformin.
The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS 1000 fast and PKS 1000 fed, included all treated subjects in Part 1 and Part 2, respectively, who provided at least 1 observation for at least 1 primary endpoint, without important protocol violations regarding the statistical evaluation of pharmacokinetic endpoints.||ng∙h/mL||Geometric Coefficient of Variation|Geometric Mean
649270|NCT02084082|Secondary|Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)|"AUC0−inf (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) for Linagliptin.
The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS 1000 fast and PKS 1000 fed, included all treated subjects in Part 1 and Part 2, respectively, who provided at least 1 observation for at least 1 primary endpoint, without important protocol violations regarding the statistical evaluation of pharmacokinetic endpoints.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
649271|NCT02084082|Primary|Cmax of Metformin in Plasma|Cmax (maximum measured concentration of the Metformin in plasma) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS 1000 fast and PKS 1000 fed, included all treated subjects in Part 1 and Part 2, respectively, who provided at least 1 observation for at least 1 primary endpoint, without important protocol violations regarding the statistical evaluation of pharmacokinetic endpoints.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
649272|NCT02084082|Primary|Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)|AUC 0-t (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS 1000 fast and PKS 1000 fed, included all treated subjects in Part 1 and Part 2, respectively, who provided at least 1 observation for at least 1 primary endpoint, without important protocol violations regarding the statistical evaluation of pharmacokinetic endpoints.||ng∙h/mL||Geometric Coefficient of Variation|Geometric Mean
649273|NCT02084082|Primary|Maximum Measured Concentration of Linagliptin in Plasma (Cmax)|Cmax (maximum measured concentration of Linagliptin in plasma) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS 1000 fast and PKS 1000 fed, included all treated subjects in Part 1 and Part 2, respectively, who provided at least 1 observation for at least 1 primary endpoint, without important protocol violations regarding the statistical evaluation of pharmacokinetic endpoints.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
649274|NCT02084082|Primary|Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval From 0 to 72 Hours (AUC0-72)|AUC 0-72 (area under concentration-time curve of the Linagliptin in plasma from 0 to 72 hours) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS 1000 fast and PKS 1000 fed, included all treated subjects in Part 1 and Part 2, respectively, who provided at least 1 observation for at least 1 primary endpoint, without important protocol violations regarding the statistical evaluation of pharmacokinetic endpoints.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
649275|NCT02084069|Primary|Atrial Fibrillation Incidence After Open Cardiac Valve Repair||Within 5 days after open cardiac valve repair|||participants|||Number
649276|NCT02084056|Secondary|AUC0-inf of Metformin in Plasma|"AUC0−inf(area under the concentration-time curve of the metformin in plasma over the time interval from 0 extrapolated to infinity) for Metformin.
The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS 2000 fast and PKS 2000 fed, included all treated subjects in Part 1 and Part 2, respectively, who provided at least 1 observation for at least 1 primary endpoint, without important protocol violations regarding the statistical evaluation of pharmacokinetic endpoints.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
649277|NCT02084056|Secondary|Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)|"AUC0−inf (area under the concentration-time curve of linagliptin in plasma over the time interval from 0 extrapolated to infinity) for Linagliptin.
The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS2000 Fast and PKS2000 Fed, consists of the subjects who provided at least 1 observation for at least 1 primary endpoint without Important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
649327|NCT02083380|Secondary|Kaplan-Meier Estimate of Recrudescence|Kaplan-Meier estimate of number of patients with recrudescence|Day 63|modified Intent to Treat (mITT) population : all patients who provided written informed consent, were randomised, were compliant with the single dose combination of OZ439/PQP study drug and had a confirmed positive blood film for P. falciparum asexual parasitaemia at inclusion.||% patients with recrudescence|||Number
649278|NCT02084056|Primary|Cmax of Metformin in Plasma|Cmax (maximum measured concentration of Metformin in plasma) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS2000 Fast and PKS2000 Fed, consists of the subjects who provided at least 1 observation for at least 1 primary endpoint without Important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
649279|NCT02084056|Primary|Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)|AUC 0-tz (Area under the concentration-time curve of metformin in plasma over the time interval from 0 to the last quantifiable data point) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS2000 Fast and PKS2000 Fed, consists of the subjects who provided at least 1 observation for at least 1 primary endpoint without Important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
649280|NCT02084056|Primary|Maximum Measured Concentration of Linagliptin in Plasma (Cmax)|Cmax (maximum measured concentration of Linagliptin in plasma) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS2000 Fast and PKS2000 Fed, consists of the subjects who provided at least 1 observation for at least 1 primary endpoint without Important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
649281|NCT02084056|Primary|Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval From 0 to 72 Hours (AUC0-72)|AUC 0-72 (area under the concentration-time curve of Linagliptin in plasma from 0 to 72 hours) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS2000 Fast and PKS2000 Fed, consists of the subjects who provided at least 1 observation for at least 1 primary endpoint without Important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
649282|NCT02083965|Secondary|Development of Inhibitor as Measured by the Nijmegen-Modified Bethesda Assay|An inhibitor test result ≥0.6 Bethesda units (BU)/mL, confirmed on 2 separate samples drawn 2 to 4 weeks apart, was considered positive. Both tests were to be performed by the central laboratory using the Nijmegen-modified Bethesda Assay. An exact 95% confidence interval (CI) for the proportion of subjects with a confirmed inhibitor was calculated using the Clopper-Pearson method for a binomial proportion. Percentage of participants with confirmed inhibitor development was summarized overall.|Predose, Month 3, Month 6/early withdrawal. Additionally: If inhibitor suspected; at 10-15 EDs; 2-4 weeks prior to scheduled surgery; preoperatively on day of surgery; 1-2 weeks post-surgery; at last postoperative visit (last 2 for major surgery only)|The Safety Analysis Set included participants who received at least 1 dose of rFVIIIFc.||percentage of participants||95% Confidence Interval|Number
649283|NCT02083965|Secondary|Vz as Measured by Two-Stage Chromogenic Clotting Assay|The theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.||mL/kg||95% Confidence Interval|Geometric Mean
649284|NCT02083965|Secondary|DNAUC as Measured by Two-Stage Chromogenic Clotting Assay|Dose normalized area under the FVIII activity-time curve.|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.||IU*h/dL per IU/kg||95% Confidence Interval|Geometric Mean
649285|NCT02083965|Secondary|AUCext as Measured by Two-Stage Chromogenic Clotting Assay|Percentage of AUCinf extrapolated from the last data point to infinity.|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.||percentage of AUCinf||95% Confidence Interval|Geometric Mean
649286|NCT02083965|Secondary|Lambda Z as Measured by Two-Stage Chromogenic Clotting Assay|First order rate constant associated with the terminal portion of the curve (lambda z).|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.||1/h||95% Confidence Interval|Geometric Mean
649287|NCT02083965|Secondary|AUClast as Measured by Two-Stage Chromogenic Clotting Assay|Area under the plasma concentration time-curve from zero to the last measured concentration.|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.||IU*h/dL||95% Confidence Interval|Geometric Mean
649288|NCT02083965|Secondary|Tmax as Measured by Two-Stage Chromogenic Clotting Assay|Time at which maximum activity (Cmax) is observed.|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.||hours||95% Confidence Interval|Geometric Mean
649289|NCT02083965|Secondary|MRT as Measured by Two-Stage Chromogenic Clotting Assay|The average time at which the number of absorbed molecules reside in the body, after single-dose administration.|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.||hours||95% Confidence Interval|Geometric Mean
649290|NCT02083965|Secondary|Vss as Measured by Two-Stage Chromogenic Clotting Assay|The apparent volume of distribution at steady state. (Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.)|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.||mL/kg||95% Confidence Interval|Geometric Mean
649291|NCT02083965|Secondary|CL as Measured by Two-Stage Chromogenic Clotting Assay|The measure of the efficiency of the body to remove the drug and the unit is the volume of the plasma or blood cleared of drug per unit time.|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.||mL/h/kg||95% Confidence Interval|Geometric Mean
649292|NCT02083965|Secondary|t½ as Measured by Two-Stage Chromogenic Clotting Assay|Time required for the concentration of the drug to reach half of its original value.|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.||hours||95% Confidence Interval|Geometric Mean
649293|NCT02083965|Secondary|Cmax as Measured by Two-Stage Chromogenic Clotting Assay|Maximum measured concentration of rFVIIIFc.|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.||IU/dL||95% Confidence Interval|Geometric Mean
649294|NCT02083965|Secondary|IR, K Value as Measured by Two-Stage Chromogenic Clotting Assay|The rise in FVIII activity in IU/dL per unit dose administered in IU/kg (IR, K value), as estimated from the FVIII activity data.|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.||IU/dL per IU/kg||95% Confidence Interval|Geometric Mean
649295|NCT02083965|Secondary|AUCinf as Estimated From the FVIII Activity Data as Measured by Two-Stage Chromogenic Clotting Assay|Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞).|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.||IU*h/dL||95% Confidence Interval|Geometric Mean
649296|NCT02083965|Secondary|Terminal Exponential Volume of Distribution (Vz) as Measured by aPTT|The theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.||mL/kg||95% Confidence Interval|Geometric Mean
649297|NCT02083965|Secondary|Dose Normalized Area Under the Curve (DNAUC) as Measured by aPTT Clotting Assay|Dose normalized area under the FVIII activity-time curve.|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.||IU*h/dL per IU/kg||95% Confidence Interval|Geometric Mean
649298|NCT02083965|Secondary|Percentage of AUCinf From the Last Data Point to Infinity (AUCext) as Measured by aPTT Clotting Assay|Percentage of AUCinf extrapolated from the last data point to infinity.|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.||percentage of AUCinf||95% Confidence Interval|Geometric Mean
653967|NCT01972776|Primary|Change From Baseline in Absolute Number of Sputum Neutrophils (Part 2)||Baseline, 8 weeks|Part 2 was terminated early. Therefore, primary and secondary outcomes for part 2 were not assessed.|||||
649299|NCT02083965|Secondary|Terminal Exponential Rate Constant (Lambda Z) as Measured by aPTT Clotting Assay|First order rate constant associated with the terminal portion of the curve (lambda z) .|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.||1/h||95% Confidence Interval|Geometric Mean
649300|NCT02083965|Secondary|Area Under the Curve to the Last Measurable Time Point (AUClast) as Measured by aPTT Clotting Assay|Area under the plasma concentration time-curve from zero to the last measured concentration.|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.||IU*h/dL||95% Confidence Interval|Geometric Mean
649301|NCT02083965|Secondary|Time of Cmax (Tmax) as Measured by aPTT Clotting Assay|Time at which maximum activity (Cmax) is observed.|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.||hours||95% Confidence Interval|Geometric Mean
649302|NCT02083965|Secondary|Mean Residence Time (MRT) as Measured by the aPTT Clotting Assay|The average time at which the number of absorbed molecules reside in the body, after single-dose administration.|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.||hours||95% Confidence Interval|Geometric Mean
649303|NCT02083965|Secondary|Volume of Distribution at Steady State (Vss) as Measured by the aPTT Clotting Assay|The apparent volume of distribution at steady state. (Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.)|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.||mL/kg||95% Confidence Interval|Geometric Mean
649304|NCT02083965|Secondary|Clearance (CL) as Measured by the aPTT Clotting Assay|The measure of the efficiency of the body to remove the drug and the unit is the volume of the plasma or blood cleared of drug per unit time.|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.||mL/h/kg||95% Confidence Interval|Geometric Mean
649305|NCT02083965|Secondary|Half-life (t½) as Measured by aPTT Clotting Assay|Time required for the concentration of the drug to reach half of its original value.|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.||hours||95% Confidence Interval|Geometric Mean
649306|NCT02083965|Secondary|Maximum Activity (Cmax) as Measured by the aPTT Clotting Assay|Maximum measured concentration of rFVIIIFc.|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.||IU/dL||95% Confidence Interval|Geometric Mean
649307|NCT02083965|Primary|Incremental Recovery (IR, K Value) as Estimated From the FVIII Activity Data Measured by aPTT Clotting Assay|The rise in FVIII activity in IU/dL per unit dose administered in IU/kg (IR, K value), as estimated from the FVIII activity data.|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.||IU/dL||95% Confidence Interval|Geometric Mean
649308|NCT02083965|Primary|Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) as Measured by Activated Partial Thromboplastin Time (aPTT) Clotting Assay|Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞).|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.||IU*h/dL||95% Confidence Interval|Geometric Mean
649328|NCT02083380|Secondary|Kaplan-Meier Estimate of Recurrence|Kaplan-Meier estimate of number of recurrent infections (either recrudescence or new infection)|Day 63|modified Intent to Treat (mITT) population : all patients who provided written informed consent, were randomised, were compliant with the single dose combination of OZ439/PQP study drug and had a confirmed positive blood film for P. falciparum asexual parasitaemia at inclusion.||% population recurring|||Number
649470|NCT02080481|Secondary|> 1 Block Attempt|Number of block attempts was collected for each patient as > 1 block attempt versus 1 attempt. A block attempt was defined as pulling the block needle back to skin and redirecting it.|from start of block procedure until block placement|||Participants|||Count of Participants
649309|NCT02083679|Secondary|Number of Subjects With Treatment-emergent Adverse (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death|An adverse event (AE) was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. AEs were considered treatment emergent if they started on or after the day of first administration of the first trial treatment given (Sym004 or one of the individual Platinum-Doublet therapies) or if they worsened after receiving first dose of treatment.|Day 1 up to 28 days after last dose of study drug (up to 53 weeks)|The safety analysis set included all 15 subjects who were administered any dose of the trial medication.||subjects|||Number
649310|NCT02083679|Primary|Number of Subjects With Dose Limiting Toxicities (DLTs)|DLT: any National Cancer Institute Common Toxicity Criteria for Adverse Events Version 4.03 Grade 4 hematologic or Grade 3/4 non-hematologic toxicities that occurred during DLT observation period and were considered by Investigator to be at least possibly related to trial treatment, and were confirmed by Safety Monitoring Committee (SMC), with exception of Grade 4 neutropenia for not >5 days; Grade 4 lymphocytopenia/ thrombocytopenia for not >5 days; fatigue/headache lasting < 7 days; nausea/vomiting/diarrhoea lasting not >3 days; asymptomatic Grade 3 increase in liver function tests that resolve to baseline within 7 days; Mucositis >= Grade 3 lasting < 7 days; Grade 3 hyperglycemia that resolves in < 7 days; any laboratory values >Grade 3 without any clinical correlate (resolve within 5 days); Grade 3 skin toxicities that resolve to Grade 2 within 7 days; Grade 3/4 hypomagnesemia that resolves within 5 days. Subjects with DLTs presented based on investigator and SMC decision.|Day 1 to Day 21 of Cycle 1|The dose limiting toxicity set included all 15 subjects in the safety analysis set (SAF) who received all planned trial medication doses during the first 21 days following the first dose of Sym004.||Subjects|||Number
649311|NCT02083406|Secondary|PQ Cmax|PQ Maximum observed concentration|Up to 168h post-dose|All subjects who received at least one dose of study drug and had sufficient plasma concentration data for PK parameter estimation||ng/mL||Geometric Coefficient of Variation|Geometric Mean
649312|NCT02083406|Secondary|Piperaquine (PQ) AUC(0-168h)|PQ Area under the plasma concentration versus time curve|Up to 168h post-dose|All subjects who received at least one dose of study drug and had sufficient plasma concentration data for PK parameter estimation||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
649313|NCT02083406|Primary|OZ439 Cmax|OZ439 Maximum observed concentration|Up to 168 hours post-dose|All subjects who received at least one dose of study drug and had sufficient plasma concentration data for PK parameter estimation||ng/mL||Geometric Coefficient of Variation|Geometric Mean
649314|NCT02083406|Primary|OZ439 AUC(0-168h)|OZ439 Area under the plasma concentration (AUC) versus time curve|Up to 168 hours post-dose|All subjects who received at least one dose of study drug and had sufficient plasma concentration data for pharmacokinetics (PK) parameter estimation||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
649315|NCT02083380|Other Pre-specified|Artefenomel Cday7 African Patients (>=0.5 to <= 2 Years)|Artefenomel concentration on Day 7 in African Patients >= 0.5 to <=2 years. All Treatment arms.|Day 7|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
649316|NCT02083380|Other Pre-specified|Artefenomel Cday7 African Patients (>2 to <= 5 Years)|Artefenomel concentration on Day 7 in African Patients >2 to <= 5 years. All Treatment arms.|Day 7|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
649317|NCT02083380|Other Pre-specified|Artefenomel Cday7 African Patients (> 5 Years)|Artefenomel concentration on Day 7 in African Patients > 5 years. All Treatment arms.|Day 7|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
649318|NCT02083380|Other Pre-specified|Artefenomel Cday7 Asian Patients (All Ages)|Artefenomel concentration on Day 7 in Asian Patients (all ages). All Treatment arms.|Day 7|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
649319|NCT02083380|Other Pre-specified|Piperaquine: Cday7 Africa (>=0.5 to <= 2 Years)|Piperaquine concentration at Day7 in African patients >= 0.5 and <= 2 years|Day 7|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
649320|NCT02083380|Other Pre-specified|Piperaquine: Cday7 Africa (>2 to <= 5 Years)|Piperaquine concentration at Day7 in African patients > 2 and <= 5years|Day 7|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
649321|NCT02083380|Other Pre-specified|Piperaquine: Cday7 Africa (> 5 Years)|Piperaquine concentration at Day7 in African patients > 5 years|Day 7|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
649322|NCT02083380|Other Pre-specified|Piperaquine: Cday7 Asia (All Ages)|Piperaquine concentration at Day7 in Asian patients all ages|Day 7|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
649323|NCT02083380|Secondary|PRR48|Parasite reduction ratio at 48 hours post dose|0, 6, 12, 18, 24, 30, 36 and 48 hours post dose|Primary analysis population was the per protocol population defined as all patients comprising the ITT set and without major protocol deviations. Including insufficient evidence of study indication, no baseline parasitemia and non-compliance with study drug administration. Subjects with sufficient data points to determine PRR48||ratio||Inter-Quartile Range|Median
649324|NCT02083380|Secondary|Fever Clearance Time|Time to fever clearance (hours)|Day 42|Primary analysis population was the per protocol population defined as all patients comprising the ITT set and without major protocol deviations. Including insufficient evidence of study indication, no baseline parasitemia and non-compliance with study drug administration.||hours||95% Confidence Interval|Median
649325|NCT02083380|Secondary|Parasite Clearance Time|Time post dose to parasite clearance|0, 6, 12, 18, 24, 30, 36, 48 and 72 hours post dose|Primary analysis population was the per protocol population defined as all patients comprising the ITT set and without major protocol deviations. Including insufficient evidence of study indication, no baseline parasitemia and non-compliance with study drug administration.||hours||95% Confidence Interval|Median
649326|NCT02083380|Secondary|Kaplan-Meier Estimate of New Infection Rate|Kaplan-Meier estimate of number of patients with new infections|Day 63|modified Intent to Treat (mITT) population : all patients who provided written informed consent, were randomised, were compliant with the single dose combination of OZ439/PQP study drug and had a confirmed positive blood film for P. falciparum asexual parasitaemia at inclusion.||% population with new infection|||Number
649329|NCT02083380|Secondary|Crude ACPR at Day 63 in the ITT Population|Crude adequate clinical and parasitological response at Day 63 in the ITT population|Day 63|Intent to Treat (ITT) population : all patients who provided written informed consent, were randomised, received the single dose combination of OZ439/PQP study drug (or part thereof), and had a confirmed positive blood film for P. falciparum asexual parasitaemia at inclusion.||% ACPR unadjusted (crude)||95% Confidence Interval|Number
649330|NCT02083380|Secondary|Crude ACPR at Day 42 in the ITT Population|Crude adequate clinical and parasitological response at Day 42 in the ITT population|Day 42|Intent to Treat (ITT) population : all patients who provided written informed consent, were randomised, received the single dose combination of OZ439/PQP study drug (or part thereof), and had a confirmed positive blood film for P. falciparum asexual parasitaemia at inclusion.||% ACPR unadjusted (crude)||95% Confidence Interval|Number
649331|NCT02083380|Secondary|Crude ACPR at Day 28 in the ITT Population|Crude adequate clinical and parasitological response at Day 28 in the ITT population|Day 28|Intent to Treat (ITT) population : all patients who provided written informed consent, were randomised, received the single dose combination of OZ439/PQP study drug (or part thereof), and had a confirmed positive blood film for P. falciparum asexual parasitaemia at inclusion.||% ACPR unadjusted (crude)||95% Confidence Interval|Number
649332|NCT02083380|Secondary|PCR-adjusted ACPR at Day 63 in the ITT Population|PCR-adjusted adequate clinical and parasitological response at Day 63 in the ITT population|Day 63|Intent to Treat (ITT) population : all patients who provided written informed consent, were randomised, received the single dose combination of OZ439/PQP study drug (or part thereof), and had a confirmed positive blood film for P. falciparum asexual parasitaemia at inclusion.||% ACPR PCR-adjusted||95% Confidence Interval|Number
649333|NCT02083380|Secondary|PCR-adjusted ACPR at Day 42 in the ITT Population|PCR-adjusted adequate clinical and parasitological response at Day 42 in the ITT population|Day 42|Intent to Treat (ITT) population : all patients who provided written informed consent, were randomised, received the single dose combination of OZ439/PQP study drug (or part thereof), and had a confirmed positive blood film for P. falciparum asexual parasitaemia at inclusion.||% ACPR PCR-adjusted||95% Confidence Interval|Number
649334|NCT02083380|Secondary|PCR-adjusted ACPR at Day 28 in the ITT Population|PCR-adjusted adequate clinical and parasitological response at Day 28. Intent to Treat ( ITT) population.|Day 28|Intent to Treat (ITT) population : all patients who provided written informed consent, were randomised, received the single dose combination of OZ439/PQP study drug (or part thereof), and had a confirmed positive blood film for P. falciparum asexual parasitaemia at inclusion.||% ACPR PCR-adjusted||95% Confidence Interval|Number
649335|NCT02083380|Secondary|Crude ACPR at Day 63 in the PP Population|Crude adequate clinical and parasitological response at Day 63|Day 63|Primary analysis population was the per protocol population defined as all patients comprising the ITT set and without major protocol deviations. Including insufficient evidence of study indication, no baseline parasitemia and non-compliance with study drug administration. The PP population comprised 93.3% of the randomized population.||% ACPR unadjusted (crude)||95% Confidence Interval|Number
649336|NCT02083380|Secondary|Crude ACPR at Day 42 in the PP Population|Crude adequate clinical and parasitological response at Day 42|Day 42|Primary analysis population was the per protocol population defined as all patients comprising the ITT set and without major protocol deviations. Including insufficient evidence of study indication, no baseline parasitemia and non-compliance with study drug administration.||% ACPR unajusted (crude)||95% Confidence Interval|Number
649337|NCT02083380|Secondary|Crude ACPR at Day 28 in the PP Population|Crude adequate clinical and parasitological response at Day 28|Day 28|Primary analysis population was the per protocol population defined as all patients comprising the ITT set and without major protocol deviations. Including insufficient evidence of study indication, no baseline parasitemia and non-compliance with study drug administration. The PP population comprised 93.3% of the randomized population.||% ACPR unadjusted (crude)||95% Confidence Interval|Number
649338|NCT02083380|Secondary|PCR-adjusted ACPR at Day 63 in the PP Population|PCR-adjusted adequate clinical and parasitological response at Day 63|Day 63|Primary analysis population was the per protocol population defined as all patients comprising the ITT set and without major protocol deviations. Including insufficient evidence of study indication, no baseline parasitemia and non-compliance with study drug administration.||% ACPR PCR-adjusted||95% Confidence Interval|Number
649339|NCT02083380|Secondary|PCR - Adjusted ACPR at Day 42 in the PP Population|PCR - adjusted adequate clinical and parasitological response at Day 42|Days 42|Primary analysis population was the per protocol population defined as all patients comprising the ITT set and without major protocol deviations. Including insufficient evidence of study indication, no baseline parasitemia and non-compliance with study drug administration.||% ACPR PCR-adjusted||95% Confidence Interval|Number
649340|NCT02083380|Primary|PCR-adjusted ACPR at Day 28 in the PP Population: Africa (>= 0.5 to <= 2 Years)|"PCR-adjusted adequate clinical and parasitological response (ACPR) at Day 28: defined as: absence of parasitaemia on Day 28, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure (ETF), late clinical failure (LCF) or late parasitological failure (LPF). Definition of ETF, LCF and LPF according to a modified standard WHO classification.
95% Clopper-Pearson 2-sided CI constructed around the single binomial proportion per treatment arm and total."|Day 28|Primary analysis population was the per protocol population defined as all patients comprising the ITT set and without major protocol deviations. Including insufficient evidence of study indication, no baseline parasitemia and non-compliance with study drug administration.||% ACPR PCR-adjusted||95% Confidence Interval|Number
649341|NCT02083380|Primary|PCR-adjusted ACPR at Day 28 in the PP Population: Africa (>2 to <= 5 Years)|"PCR-adjusted adequate clinical and parasitological response (ACPR) at Day 28: defined as: absence of parasitaemia on Day 28, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure (ETF), late clinical failure (LCF) or late parasitological failure (LPF). Definition of ETF, LCF and LPF according to a modified standard WHO classification.
95% Clopper-Pearson 2-sided CI constructed around the single binomial proportion per treatment arm and total."|Day 28|Primary analysis population was the per protocol population defined as all patients comprising the ITT set and without major protocol deviations. Including insufficient evidence of study indication, no baseline parasitemia and non-compliance with study drug administration.||% ACPR PCR-adjusted||95% Confidence Interval|Number
649360|NCT02082912|Secondary|Change in Memory and Information Processing Speed||Baseline and at end of 3 weeks of treatment||||||
649342|NCT02083380|Primary|PCR-adjusted ACPR at Day 28 in the PP Population: Africa (< = 5 Years)|"PCR-adjusted adequate clinical and parasitological response (ACPR) at Day 28: defined as: absence of parasitaemia on Day 28, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure (ETF), late clinical failure (LCF) or late parasitological failure (LPF). Definition of ETF, LCF and LPF according to a modified standard WHO classification.
95% Clopper-Pearson 2-sided CI constructed around the single binomial proportion per treatment arm and total."|Day 28|Primary analysis population was the per protocol population defined as all patients comprising the ITT set and without major protocol deviations. Including insufficient evidence of study indication, no baseline parasitemia and non-compliance with study drug administration.||% ACPR PCR-adjusted||95% Confidence Interval|Number
649343|NCT02083380|Primary|PCR-adjusted ACPR at Day 28 in the PP Population: Africa (> Than 5 Years)|"PCR-adjusted adequate clinical and parasitological response (ACPR) at Day 28: defined as: absence of parasitaemia on Day 28, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure (ETF), late clinical failure (LCF) or late parasitological failure (LPF). Definition of ETF, LCF and LPF according to a modified standard WHO classification.
95% Clopper-Pearson 2-sided CI constructed around the single binomial proportion per treatment arm and total."|Day 28|Primary analysis population was the per protocol population defined as all patients comprising the ITT set and without major protocol deviations. Including insufficient evidence of study indication, no baseline parasitemia and non-compliance with study drug administration.||% ACPR PCR-adjusted||95% Confidence Interval|Number
649344|NCT02083380|Primary|PCR-adjusted ACPR at Day 28 in the PP Population: Africa (All Ages)|"PCR-adjusted adequate clinical and parasitological response (ACPR) at Day 28: defined as: absence of parasitaemia on Day 28, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure (ETF), late clinical failure (LCF) or late parasitological failure (LPF). Definition of ETF, LCF and LPF according to a modified standard WHO classification.
95% Clopper-Pearson 2-sided CI constructed around the single binomial proportion per treatment arm and total."|Day 28|Primary analysis population was the per protocol population defined as all patients comprising the ITT set and without major protocol deviations. Including insufficient evidence of study indication, no baseline parasitemia and non-compliance with study drug administration.||% ACPR PCR-adjusted||95% Confidence Interval|Number
649345|NCT02083380|Primary|PCR-adjusted ACPR at Day 28 in the PP Population: Asia (All Ages)|"PCR-adjusted adequate clinical and parasitological response (ACPR) at Day 28: defined as: absence of parasitaemia on Day 28, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure (ETF), late clinical failure (LCF) or late parasitological failure (LPF). Definition of ETF, LCF and LPF according to a modified standard WHO classification.
95% Clopper-Pearson 2-sided CI constructed around the single binomial proportion per treatment arm and total."|Day 28|Primary analysis population was the per protocol population defined as all patients comprising the ITT set and without major protocol deviations. Including insufficient evidence of study indication, no baseline parasitemia and non-compliance with study drug administration.||% ACPR PCR-adjusted||95% Confidence Interval|Number
649346|NCT02083380|Primary|PCR-adjusted ACPR at Day 28 in the PP Population (All Patients)|"Polymerase chain reaction (PCR)-adjusted adequate clinical and parasitological response (ACPR) at Day 28: defined as: absence of parasitaemia on Day 28, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure (ETF), late clinical failure (LCF) or late parasitological failure (LPF). Definition of ETF, LCF and LPF according to a modified standard WHO classification. Per protocol population (PP).
95% Clopper-Pearson 2-sided Confidence Interval (CI) constructed around the single binomial proportion per treatment arm and total."|Day 28|Primary analysis population was the per protocol population defined as all patients comprising the ITT set and without major protocol deviations. Including insufficient evidence of study indication, no baseline parasitemia and non-compliance with study drug administration.||% ACPR PCR-adjusted||95% Confidence Interval|Number
649347|NCT02083263|Secondary|Blood Gases:1 Month After Chest Physiotherapy Will Take Blood Gases (Kpa).|After physiotherapy will take blood gases (kpa) before chest physiotherapy and perform once a month.|1 month||||||
649348|NCT02083263|Primary|Lung Function: Lung Clearance Index|Lung clearance index was calculated as the number of lung volume turnovers (cumulative expired volume divided by the functional residual capacity) required to reduce end-tidal nitrogen concentration to 1/40th of the starting value.|up to 3 months|||lung clearance index||Standard Deviation|Mean
649349|NCT02083107|Other Pre-specified|Change in Hematocrite Value||24 hours postoperative from baseline hematocrite value|||Percentage Hematocrit||Standard Deviation|Mean
649350|NCT02083107|Secondary|Incidence of Adverse Effects||24 hours|||no. of cases experiencing side effects|||Number
649351|NCT02083107|Secondary|Incidence of Wound Sepsis||upto one week|||no. of cases experiencing wound sepsis|||Number
649352|NCT02083107|Secondary|Need for Postoperative Blood Transfusion||average 24 hours|||participants|||Number
649353|NCT02083107|Secondary|Need for Extra Analgesics||average 24 hours|||participants|||Number
649354|NCT02083107|Secondary|Time to Resume Bowel Habits||average 24 hours|||hours||Standard Deviation|Mean
649355|NCT02083107|Secondary|APGAR Score|The Apgar score is the first test given to a newborn, it is referred to as an acronym for: Appearance, Pulse, Grimace, Activity, and Respiration. Scores obtainable are between 10 and 0, with 10 being the highest possible score. Pulse: above 100 beats per minute (2), below 100 beats per minute (1), absent (0). Respiration: Normal rate and effort, good cry (2), Slow or irregular,weak cry (1), absent (0). Grimace: Pulls away, sneezes, coughs, or cries with stimulation (2), Facial movement only (1), absent (0). Activity: Active, spontaneous movement (2), Arms and legs flexed with little movement (1), absent (0). Appearance: Normal color (2), Normal color (but hands and feet are bluish) (1), Bluish-gray or pale all over (0).|1minute and 5 minutes from delivery of the fetus|||units on a scale||Standard Deviation|Mean
649356|NCT02083107|Other Pre-specified|Change in Hemoglobin Concentration||24 hours postoperative from baseline hemoglobin|||gram/dL||Standard Deviation|Mean
649357|NCT02083107|Secondary|Need for Extra Ecbolics (Oxytocin).||from start of cesarean section till the end of operation (average one hour)|||participants|||Number
649358|NCT02083107|Primary|Intraoperative Blood Loss||from start of cesarean section till the end of operation (average one hour)|||millilitres||Standard Deviation|Mean
649359|NCT02082912|Secondary|Change in Functional Motor Task Performance||Baseline and at end of 3 weeks of treatment||||||
649363|NCT02082912|Primary|Mean Change in Grip Strength of Affected Hand|Hand-grip strength was assessed using the whole hand and defined as the average of 3 trials using a calibrated Jamar dynamometer (Jamar Dynamometer, Asimow Engineering Co., Santa Monica, CA), with the elbow flexed to 90º and the forearm in a neutral position. This is the standardized method for measuring hand-grip strength with a Jamar dynamometer recommended by the American Society of Hand Therapists. Change was calculated by subtracting baseline from outcome at week 3.|Baseline, 3 weeks (end of treatment)|||Newton||Standard Deviation|Mean
649364|NCT02082769|Other Pre-specified|Absolute Change in the Serum Urate Level at the Final Visit Relative to Baseline||Baseline and Final Visit (up to 26 weeks)|||umol/l||Standard Deviation|Mean
649365|NCT02082769|Secondary|Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Final Visit||Final Visit (up to 26 weeks)|||percentage of participants|||Number
649366|NCT02082769|Primary|Percentage of Subjects Whose Last Three Serum Urate Levels Are <6.0 Milligram Per Deciliter (mg/dL)||Last 3 visits (any last 3 visits up to week 26)|||percentage of participants|||Number
649367|NCT02082392|Secondary|Blind Assessment—Patient Version|rates subject's guess as to the identity of study medication and the confidence in that guess. This assessment is necessary to document the effectiveness of the study's methods of treatment allocation concealment.|8 weeks|Data were not collected|||||
649368|NCT02082392|Secondary|California Pharmacotherapy Alliance Scale (CALPAS)—Patient Version|24 item Likert scale rating the patient's assessment of the therapeutic alliance, particularly about medication issues, with the clinician. This scale is superior to other therapeutic alliance scales because it is focused on drug treatment and does not contain items specific to psychotherapy.|8 weeks|Data were not collected|||||
649369|NCT02082392|Secondary|Schedule for Adaptive and Nonadaptive Personality (SNAP)|this questionnaire is a widely used assessment tool for personality disorders that we will also use to identify predictors of response to varying visit frequency.|8 weeks|Data were not collected|||||
649370|NCT02082392|Secondary|Revised Life Orientation Test (LOT-R)|scale developed to assess individual differences in generalized optimism versus pessimism. Degree of optimism on this scale has been correlated with the magnitude of placebo response observed in studies of placebo analgesia, and we will determine whether LOT-R scores moderate effects of therapeutic contact.|8 weeks|Data were not collected|||||
649371|NCT02082392|Secondary|Cornell Treatment Preference Index|"scale used in mental health studies to document the type and strength of patients' treatment preferences. We will use a modified version in this study asking subjects Based on your experience and how you feel right now, which of the visit frequencies in this study would be your first choice? The strength of this preference will be measured on a 5-point Likert scale."|8 weeks|Data were not collected|||||
649372|NCT02082392|Secondary|Client Satisfaction Questionnaire 8 (CSQ 8)|self-administered scale with items rating respondents’ satisfaction with mental health services they are receiving on a 4 point Likert scale. Use of the CSQ 8 will allow us to determine whether CFM and RFM are associated with differences in participant satisfaction.|8 Weeks|Data were not collected|||||
649373|NCT02082392|Secondary|Treatment Credibility and Expectancy Scale (CES)|"8 item scale in which subjects rate their impression of the credibility of the treatment and how they estimate their expectation of improvement. The CES is the most widely used measure of expectancy and has demonstrated good psychometric properties in multiple studies. For this study, the primary measure of expectancy will be item 4: By the end of the treatment period, how much improvement in your depressive symptoms do you think will occur? (0-100%)."|8 Weeks|Data were not collected|||||
649374|NCT02082392|Secondary|Quick Inventory of Depressive Symptoms—Self Report (QIDS-SR) 16 Item Scale|rating scale for depressive symptoms based on DSM criteria. A self-report measure for depressive symptoms is valuable in this study, because it is less susceptible to clinician and rater bias. The QIDS-SR has been increasingly used in antidepressant studies (e.g., STAR*D) due to its equivalent weightings for each symptom item, clearly understandable anchor points, and inclusion of all DSM criteria for depression|8 Weeks|Data were not collected|||||
649375|NCT02082392|Secondary|Blind Assessment—Clinician Version|Rates clinician's guess as to the identity of study medication and the confidence in that guess. This assessment is necessary to document the effectiveness of the study's methods of treatment allocation concealment.|8 weeks|Data were not collected|||||
649376|NCT02082392|Secondary|California Pharmacotherapy Alliance Scale (CALPAS)—Clinician Version|24 item Likert scale rating the clinician's assessment of the therapeutic alliance, particularly about medication issues, with the patient. This scale is superior to other therapeutic alliance scales because it is focused on drug treatment and does not contain items specific to psychotherapy. Prior studies using the CALPAS reported an association between therapeutic alliance and outcome, and some studies found alliance mediated the effect of expectancy on depression outcome.|Baseline week|Data were not collected|||||
649377|NCT02082392|Secondary|Treatment Emergent Symptom Scale|rating scale for physical symptoms reported during the study. This is a standard means of recording drug-related adverse effects that will allow us to assess whether contact frequency is associated with differences in side effects among study subjects.|Baseline week|Data were not collected|||||
649378|NCT02082392|Secondary|CGI Severity and Improvement|"scales developed to measure the clinician’s view of subjects’ global functioning before and after initiating a study medication. The CGI correlates well with other standard outcome measures for depression (e.g., HRSD), is sensitive to change in antidepressant trials, and offers clinically understandable anchor points.
7-point scale: 0 = Not assessed 4 = Moderately ill
1 = Normal, not at all ill 5 = Markedly ill 2 = Borderline mentally ill 6 = Severely ill 3 = Mildly ill 7 = Among the most extremely ill patients"|Baseline week|||units on a scale||Standard Deviation|Mean
649379|NCT02082392|Secondary|Hamilton Anxiety Rating Scale (HARS) 14-item Scale|Scale for anxiety symptoms administered by trained rater. The HARS is a standard measure of anxiety severity in pharmacotherapy studies that has been shown to have acceptable reliability and validity in studies of depressed patients. Each item is scored on a scale of 0 (not present) to 4(severe), with a total score range of 0–56, where <17 indi-cates mild severity, 18–24 mild to moderate severity and25–30 moderate to severe.|Baseline week|||units on a scale||Standard Deviation|Mean
649447|NCT02081014|Secondary|Glucagon Tmax (Post-insulin)|Pharmacokinetic parameter: Time to reach maximum concentration of glucagon|Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection|All randomized subjects who received at least one dose of study drug||minutes||Standard Error|Mean
649380|NCT02082392|Primary|Hamilton Rating Scale for Depression|"scale for depressive symptoms administered by trained rater. The HRSD is the standard measure of depression severity for clinical trials of antidepressants and was chosen as the primary outcome measure over other depression rating scales to ensure compatibility of study results with our meta-analyses and ongoing studies of expectancy. Although the HRSD list 21 items, the scoring is based on the first 17 items.
sum of the scores of the first 17 items (range from 0 to 54): 0-7 = NORMAL 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severe Depression >=23 = Very Severe Depression"|Baseline week|||units on a scale||Standard Deviation|Mean
649381|NCT02082288|Primary|Clinical Pregnancy|A clinical pregnancy will be determined by identifying the presence of a gestational sac at six weeks gestation on transvaginal ultrasonography.|6 weeks|||participants|||Number
649382|NCT02082262|Primary|Change From Baseline In Ocular Itching Frequency Score Using a 6-point Scale|Ocular itching frequency is assessed on a 6-poing scale, where 0 = did not occur, 1 = once in 3 days, 2 = twice in 3 days, 3 = once every day, 4 = 2 or more times every day, and 5 = virtually all the time over the past 3 days. Ocular itching frequency is evaluated over the 3 days prior to the visit. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.|Baseline, Day 70|Modified Intent-to-Treat: all enrolled patients with at least one follow-up ocular itching frequency score||Scores on a Scale||Standard Deviation|Mean
649383|NCT02082184|Secondary|Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 194.|"The Diabetes Treatment Satisfaction Questionnaire change (DTSQc) score is used to assess relative change in participant satisfaction from baseline. The questionnaire consists of 8 items, 6 of which (1 and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale (which ranges from -3 (much less satisfied) to +3 (much more satisfied). The scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from -18 (much less satisfied) to +18 (much more satisfied).
There is one question to assess the change in perceived frequency of Hypoglycaemia and one question to assess change in perceived frequency of Hyperglycaemia. Each question is rated on a 7-point Likert scale (-3 to +3), -3 (much less of the time now) to +3 (much more of the time now).
The ANCOVA adjusts for baseline DTSQs (status version)."|Baseline and Day 194|||units on a scale||Standard Deviation|Mean
649384|NCT02082184|Secondary|System Utilisation|Sensor utilisation assessed by percentage of sensor glucose data collected by the intervention group.|Days 15 to 208|138 subjects included in the analysis, 11 were not included due to missing data.||percentage of sensor glucose collected||Standard Deviation|Mean
649385|NCT02082184|Secondary|Number of Glucose Measurements Performed|Number of blood glucose fingerstick tests per day by intervention and control group during days 15 to 208. The number of sensor scans performed by the intervention group during days 15 to 208.|Days 15 to 208|||number of measurements per day||Standard Deviation|Mean
649386|NCT02082184|Secondary|Time Spent >180 mg/dL and >240 mg/dL|Difference in time >180 mg/dL and >240mg/dL (hours per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15) using ANCOVA.|Baseline and Days 194 to 208|||hours per day||Standard Deviation|Mean
649387|NCT02082184|Secondary|Frequency of Episodes <70 mg/dL and <55 mg/dL|Difference in frequency of episodes <70 mg/dL and <55 mg/dL (number per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15) using ANCOVA.|Baseline and Days 194 to 208|||number of episodes per day||Standard Deviation|Mean
649388|NCT02082184|Secondary|Time Spent <70 mg/dL and <55 mg/dL|Difference in time <70 mg/dL and <55 mg/dL (hours per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15) using ANCOVA.|Baseline and Days 194 to 208|||hours per day||Standard Deviation|Mean
649389|NCT02082184|Secondary|Time in Range|Difference in time in range 70-180 mg/dL between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15 time in range) using ANCOVA.|Baseline and Days 194 to 208|||hours per day||Standard Deviation|Mean
649390|NCT02082184|Primary|HbA1c at 6 Months|Difference in HbA1c between intervention and control group at day 194 adjusting for baseline HbA1c at day 1 using ANCOVA.|Baseline and Day 194|||percentage of Glycated Haemoglobin||Standard Deviation|Mean
649391|NCT02082158|Secondary|To Collect Healthcare Worker Feedback About Perceived Tolerability of Novel Respirator Designs|Subjects will answer questions concerning comfort of respirator utilizing a Likert scale instrument that has been validated to capture comfort and tolerability assessments. This is a single visit study; there is no follow-up. Comfort and tolerability measurements will be compared between new and standard respirator models. The Respirator Comfort, Wearing Experience and Function Instrument (R-COMFI) is made up of 3 subscales: 1) Discomfort subscale (10 items, scored 0 to 2, score range of 0-20), 2) General Wearing Experience subscale (6 items, scored 0 to 2, score range of 0-12), and the 3) Function subscale (5 items, scored 0 to 3, score range of 0-15). An overall comfort and tolerability score is achieved by the sum total of all subscales. The instrument score range is 0-47. Higher scores equate to higher levels of discomfort and inability to tolerate respirator.|Visit 1|Subjects who passed fit-testing, performed study activities and completed survey on the comfort and tolerability of the respirator worn.||units on a scale||Standard Deviation|Mean
649392|NCT02082158|Primary|To Collect Healthcare Worker Feedback About Perceived Comfort of Novel Respirator Designs|Subject will participate in set study activities wearing the respirator that he/she was randomized to. Following, Subjects will answer questions concerning comfort of respirator utilizing a Likert scale instrument that has been validated to capture comfort and tolerability assessments. This is a single visit study; there is no follow-up. Comfort and tolerability measurements will be compared between new and standard respirator models. The Respirator Comfort, Wearing Experience and Function Instrument (R-COMFI) is made up of 3 subscales: 1) Discomfort subscale (10 items, scored 0 to 2, score range of 0-20), 2) General Wearing Experience subscale (6 items, scored 0 to 2, score range of 0-12), and the 3) Function subscale (5 items, scored 0 to 3, score range of 0-15). An overall comfort and tolerability score is achieved by the sum total of all subscales. The instrument score range is 0-47. Higher scores equate to higher levels of discomfort and inability to tolerate respirator.|Visit 1|Subjects who passed fit-testing, performed study activities and completed survey on the comfort and tolerability of the respirator worn.||units on a scale||Standard Deviation|Mean
649393|NCT02081859|Secondary|Implantation Rate|Percent of embryos implanted assessed at time of ultrasound|6 weeks|||Percentage of embryos|||Number
649395|NCT02081677|Primary|Percentage of Reported Ocular Symptoms (Variable Vision)|The Ocular symptom Variable Vision was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.|Baseline and 4-Week Follow-up|Subjects that completed all study visits without a major protocol deviation.||Percentage of Eyes|Eyes||Number
649396|NCT02081677|Primary|Percentage of Reported Ocular Symptoms (Redness)|The Ocular symptom Redness wasassessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.|Baseline and 4-Week Follow-up|Subjects that completed all study visits without a major protocol deviation.||Percentage of Eyes|Eyes||Number
649397|NCT02081677|Primary|Percentage of Reported Ocular Symptoms (Lens Awareness)|The Ocular symptom Lens awareness was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.|Baseline and 4-Week Follow-up|Subjects that completed all study visits without a major protocol deviation.||Percentage of Eyes|Eyes||Number
649398|NCT02081677|Primary|Percentage of Reported Ocular Symptoms (Itchiness/Scratchiness)|The Ocular symptom Itchiness/Scratchiness was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.|Baseline and 4-Week Follow-up|Subjects that completed all study visits without a major protocol deviation.||Percentage of Eyes|Eyes||Number
649399|NCT02081677|Primary|Percentage of Reported Ocular Symptoms (Irritation/Discomfort)|The Ocular symptom Irritation/Discomfort was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.|Baseline and 4-Week Follow-up|Subjects that completed all study visits without a major protocol deviation.||Percentage of Eyes|Eyes||Number
649400|NCT02081677|Primary|Percentage of Reported Ocular Symptoms (Grittiness/Foreign Body Sensation)|The Ocular symptom Grittiness/Foreign Body Sensation was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.|Baseline and 4-Week Follow-up|Subjects that completed all study visits without a major protocol deviation.||Percentage of Eyes|Eyes||Number
649401|NCT02081677|Primary|Percentage of Reported Ocular Symptoms (Dryness)|The Ocular symptom Dryness was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.|Baseline and 4-Week Follow-up|Subjects that completed all study visits without a major protocol deviation.||Percentage of Eyes|Eyes||Number
649402|NCT02081677|Primary|Percentage of Reported Ocular Symptoms (Cloudy/Blurry/Hazy)|The Ocular symptom Cloudy/Blurry/Hazy was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.|Baseline and 4-Week Follow-up|Subjects that completed all study visits without a major protocol deviation.||Percentage of Eyes|Eyes||Number
649403|NCT02081677|Primary|Tarsal Abnormalities|Tarsal abnormalities were assessed using a biomicroscope at baseline, post lens fitting, 1-, 2- and 4- week evaluations in both eyes and was graded with a 5-point scale (Grade 0, 1, 2, 3 and 4) with grade 0 represents the absence of abnormalities and 1 to 4 representing successively worse abnormalities (i.e. Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). The percentage of eyes with Grade 3 or higher was reported.|1-, 2- and 4-Week Follow-up|The analysis population consists of all subjects that completed all study visits without a major protocol deviation.||Percentage of Eyes|Subject Eyes||Number
649404|NCT02081677|Primary|Corneal Staining|Corneal Staining was assessed using a bio-microscope at baseline and 4- week evaluations in both eyes and was graded with a 5-point scale (Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). The Percentage of eyes with Grade 3 or higher was reported.|Baseline and 4-Week Follow-up|All subjects that completed all study visits without a major protocol deviation.||Percentage of Eyes|Subject Eyes||Number
649405|NCT02081677|Primary|Corneal Neovascularization|Corneal Neovascularization was assessed using a bio-microscope at baseline and 4- week evaluations in both eyes and was graded with a 5-point scale (Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). The Percentage of eyes with Grade 3 or higher was reported.|Baseline and 4-Week Follow-up|All subjects that completed all study visits without a major protocol deviation.||Percentage of Eyes|Subject Eyes||Number
649406|NCT02081677|Primary|Conjunctival Injection|Conjunctival Injection was assessed using a bio-microscope at baseline and 4- week evaluations in both eyes and was graded with a 5-point scale (Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). The Percentage of eyes with Grade 3 or higher was reported.|Baseline and 4-Week Follow-up|All subjects that completed all study visits without a major protocol deviation.||Percentage of Eyes|Subject Eyes||Number
649448|NCT02081014|Secondary|Glucagon Tmax (Fasting)|Pharmacokinetic parameter: Time to reach maximum concentration of glucagon|Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 180 minutes post-injection|All randomized subjects who received at least one dose of study drug||minutes||Standard Error|Mean
649407|NCT02081677|Primary|Corneal Edema|Corneal Edema was assessed using a bio-microscope at baseline and 4- week evaluations in both eyes and was graded with a 5-point scale (Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). The Percentage of eyes with Grade 3 or higher was reported.|Baseline and 4-Week Follow-up|All subjects that completed all study visits without a major protocol deviation.||Percentage of Eyes|Subject Eyes||Number
649408|NCT02081677|Primary|Percentage of Reported Ocular Symptoms (Burning/Stinging)|The Ocular symptom Burning/Stinging was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.|Baseline and 4-Week Follow-up|Subjects that completed all study visits without a major protocol deviation.||Percentage of Eyes|Eyes||Number
649409|NCT02081677|Primary|Lens Fitting Characteristics|Lens fit was assessed for each subject eye at post lens fitting and 4- week follow-up evaluations. Lens fit is a binary response as acceptable or unacceptable lens fit. The percentage of eyes with acceptable lens fit was reported.|Post Lens Fitting and 4-Week Follow-up|The analysis population consists of all subjects that completed all study visits without a major protocol deviation.||Percentage of Eyes|Eyes||Number
649410|NCT02081677|Primary|Visual Acuity (LogMAR)|Visual Acuity (LogMAR) was assessed bionocularly at the 4-week follow-up evaluations. The average visual acuity (LogMAR) for each lens was reported.|4-Week Follow-up|Subjects that completed all study visits without a major protocol deviation.||LogMAR|Eyes|Standard Deviation|Mean
649411|NCT02081677|Primary|Bulbar Conjunctival Redness|Bulbar Conjunctival Redness was assessed for each subject and eye at baseline and 2-week follow-up evaluations. Bulbar Redness was assessed in 4 regions Inferior, Nasal, Temporal and Superior and Graded using an Efron Grading scale for bulbar redness in 0.5 unit increments (Grade 0:None, Grade 1:Trace, Grade 2: Mild, Grade 3: Moderate and Grade 4: Severe). The average Grade across all four regions can range from 0 to 16 where lower values indicate better performance. The average Grade for each individual region can range from 0 to 4. The average grade across all regions was reported for each lens and time point.|Baseline and 2-Week Follow-up|Subjects that completed all study visits without a major protocol deviation.||units on a scale|Subject Eye|Standard Deviation|Mean
649412|NCT02081677|Primary|Limbal Conjunctival Redness|Limbal Conjunctival Redness was assessed for each subject and eye at baseline and 2-week follow-up evaluations. Limbal Redness was assessed in 4 regions Inferior, Nasal, Temporal and Superior and Graded using an Efron Grading scale for limbal redness in 0.5 unit increments (Grade 0:None, Grade 1:Trace, Grade 2: Mild, Grade 3: Moderate and Grade 4: Severe). The average Grade across all four regions can range from 0 to 16 where lower values indicate better performance. The average Grade for each individual region can range from 0 to 4. The average grade across all regions was reported for each lens and time point.|Baseline and 2-Week Follow-up|Subjects that completed all study visits without a major protocol deviation.||units on a scale|Subject Eye|Standard Deviation|Mean
649413|NCT02081677|Primary|Corneal Staining (Type)|Corneal Staining was collected at baseline and 4- week evaluations in both eyes using a slit lamp and was graded with a 5-point scale (i.e. Grade 0= None, Grade 1 =Micropunctate, Grade 2 = Macropunctate, Grade 3 = Coalesced Macropunctate and Grade 4 = Patch (greater or equal to 1mm). Central, interior, nasal, temporal and superior locations were evaluated. The average grade for each lens and time point was reported.|Baseline and 4-Week Follow-up|The analysis population consist of all subjects that completed all study visits without a major protocol.||Units on a scale|Subject Eyes|Standard Deviation|Mean
649414|NCT02081677|Primary|Corneal Staining (Depth)|Corneal Staining Depth was collected at baseline and 4- week evaluations in both eyes using a slit lamp and was graded with a 4-point scale (i.e. Grade 0= None, Grade 1 =Superficial epithelial, Grade 2 = Full epithelial, Grade 3 =stromal glow). Central, interior, nasal, temporal and superior locations were evaluated. The average grade for each lens and time point was reported.|Baseline and 4-Week Follow-up|The analysis population consist of all subjects that completed all study visits without a major protocol.||Units on a scale|Subject Eyes|Standard Deviation|Mean
649415|NCT02081677|Primary|Corneal Staining (Area)|Corneal Staining Area was collected at baseline and 4- week evaluations in both eyes using a slit lamp and was graded with a 11-point scale (i.e. Grade 0= 0% of region covered, Grade 1 =10% of region covered, Grade 2 = 20% of region covered, Grade 3 = 30% of region covered, Grade 4= 40% of region covered, Grade 5 = 50% of region covered, Grade 6 = 60% of region covered,Grade 7 = 70% of region covered, Grade 8 = 80% of region covered, Grade 9 = 90% of region covered and Grade 10 = 100% of region covered). Central, interior, nasal, temporal and superior locations were evaluated. The average grade for each lens and time point was reported.|Baseline and 4-Week Follow-up|The analysis population consist of all subjects that completed all study visits without a major protocol.||Units on a scale|Subject Eyes|Standard Deviation|Mean
649416|NCT02081599|Secondary|Change From Baseline in 2-hour Postprandial Plasma Glucose|The change from Baseline in 2-hour Postprandial Plasma Glucose collected at Week 16. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline 2-hour Postprandial Plasma Glucose as a covariate.|at Week 0 and Week 16|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization.||mg/dL||Standard Error|Least Squares Mean
649417|NCT02081599|Secondary|Change From Baseline in the Areas Under the Curve From 0 to 2 h (AUC0–2h) for Postprandial Plasma Glucose|The change from Baseline in AUC0–2h for Postprandial Plasma Glucose collected at Week 16. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline AUC0–2h for Postprandial Plasma Glucose as a covariate.|0, 0.5, 1, 2 hours post-dose at Week 0 and Week 16|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization.||mg*hr/dL||Standard Error|Least Squares Mean
649449|NCT02081014|Secondary|Glucagon AUC (Post-insulin)|Pharmacokinetic parameter: Area under the glucagon concentration curve from 0 to 120 minutes|Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection|All randomized subjects who received at least one dose of study drug||(pg/ml)*hour||Standard Error|Mean
649471|NCT02080481|Secondary|Block Failure|Number of patients who had block failure|start of surgery until femoral nerve block completion|||Participants|||Count of Participants
649418|NCT02081599|Secondary|Change From Baseline in Fasting Plasma Glucose|The change from Baseline in Fasting Plasma Glucose collected at Week 16. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline Fasting Plasma Glucose as a covariate.|at Week 0 and Week 16|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization. Analysis based on last observation carried forward, where the last post baseline double-blind observed value was carried forward and used for Week 16 where data was missing.||mg/dL||Standard Error|Least Squares Mean
649419|NCT02081599|Primary|Change From Baseline in HbA1c|The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 16. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate.|at Week 0 and Week 16|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization. Analysis based on last observation carried forward, where the last post baseline double-blind observed value was carried forward and used for Week 16 where data was missing.||percentage of HbA1c||Standard Error|Least Squares Mean
649420|NCT02081586|Secondary|Body Mass Index Change|Change in Body Mass Index from baseline to post intervention|baseline to 16 weeks|Of 13 initially randomized, there were 2 dropouts and one was withdrawn from the study.||kg/m^2||Full Range|Mean
649421|NCT02081586|Secondary|Diabetes Distress Scale- Change Score|Levels of diabetes distress per standardized questionnaire will be measured before intervention and after intervention. Percent change of mean score between baseline and 16 weeks is reported. Adapted from Fisher, L., Glasgow, R.E., Mullan, J.T., Skaff, M.M., Polonsky, W.H. (2008) Development of a Brief Diabetes Screening Instrument. Annals of Family Medicine; 6:246-252.|baseline to 16 weeks|Of thirteen initially randomized, one was withdrawn prior to treatment, one is missing data, and two dropped out. Therefore we do not have change scores for these pariticipants.||percent change||Full Range|Mean
649422|NCT02081586|Secondary|MEMS (Medication Electronic Monitoring System) Cap Electronic Pill Bottle Adherence|Electronically measured medication adherence, percent adherence over entire study phase. Change score was not evaluated, this measure is to determine feasability of use over time. Percent adherence is measured by the number of correct doses per day divided by the number of prescribed doses per day X 100. Percent adherence was calculated as the percentage of the prescribed doses of the medication actually taken by the patient over 16 weeks|16 weeks|||percent adherent||Full Range|Mean
649423|NCT02081586|Primary|Computer System Usability Questionnaire (CSUQ)|"The CSUQ measures feasibility and acceptability of the phone application. Adapted from Lewis JR.: IBM Computer Usability Satisfaction Questionnaires: Psychometric Evaluation and Instructions for Use. International Journal of Human-Computer Interaction 1995; 7 (1):67-78.
Scale is scored as a mean value, range is from 1 to 7. In this adaptation lower scores are better usability."|16 weeks|As per protocol, usability was analyzed for participants administered phone CBT, regardless of duration. Six subjects completed the CSUQ. Of ten initially assigned treatment, one was withdrawn prior to treatment, one missed the CSUQ, and two dropped out. Treatment as usual Arm did not use the phone.||units on a scale (1-7)||Standard Deviation|Mean
649424|NCT02081586|Primary|HbA1c Level Change Scores From Baseline to 16 Weeks|Change from baseline HbA1c level to post intervention|baseline to 16 weeks|per protocol||percent||Standard Deviation|Mean
649425|NCT02081443|Secondary|PRI Measured by VASP|PRI determined by VASP between before and after incubation with 500 nM Cangrelor in each arm of treatment|4 hours|||%PRI||Standard Error|Mean
649426|NCT02081443|Secondary|PRI Measured by VASP|PRI determined by VASP between before and after incubation with 500 nM Cangrelor in each arm of treatment|1 hour|||%PRI||Standard Error|Mean
649427|NCT02081443|Primary|Platelet Reactivity Index (PRI) Determined by Whole Blood Vasodilator-stimulated Phosphoprotein (VASP)|PRI determined by VASP between before and after incubation with 500 nM Cangrelor in each arm of treatment|Baseline|||%PRI||Standard Error|Mean
649428|NCT02081365|Secondary|Change in Avoidance Rating for Specific Phobia Module of Anxiety Disorders Interview Schedule for DSM-IV|The Anxiety Disorders Interview Schedule for DSM-IV is a semi-structured diagnostic interview for assessing DSM-IV criteria for current anxiety, depressive, somatoform, and substance use disorders. For the present investigation, only the specific phobia module of the ADIS-IV was administered to assess the presence and severity of a current diagnosis of dental phobia. Various aspects of dental phobia were assessed using the specific phobia module of the ADIS-IV. Interviewers assessed participants’ anxiety and avoidance of dental procedures on scales that ranged from 0 (none) to 8 (very severe). They also rated patients’ overall distress and impairment due to their dental phobia symptoms and assigned a clinician’s severity rating (CSR) that also ranged from 0 (none) to 8 (very severe); a CSR > 4 indicated that the participant met criteria for diagnosis of dental phobia.|Change from one week before appointment to one month after appointment|||units on a scale||Standard Error|Mean
649429|NCT02081365|Secondary|Change in Fear Rating for Specific Phobia Module of Anxiety Disorders Interview Schedule for DSM-IV|The Anxiety Disorders Interview Schedule for DSM-IV is a semi-structured diagnostic interview for assessing DSM-IV criteria for current anxiety, depressive, somatoform, and substance use disorders. For the present investigation, only the specific phobia module of the ADIS-IV was administered to assess the presence and severity of a current diagnosis of dental phobia. Various aspects of dental phobia were assessed using the specific phobia module of the ADIS-IV. Interviewers assessed participants’ anxiety and avoidance of dental procedures on scales that ranged from 0 (none) to 8 (very severe). They also rated patients’ overall distress and impairment due to their dental phobia symptoms and assigned a clinician’s severity rating (CSR) that also ranged from 0 (none) to 8 (very severe); a CSR > 4 indicated that the participant met criteria for diagnosis of dental phobia.|Change from one week before appointment to one month after appointment|||units on a scale||Standard Error|Mean
649450|NCT02081014|Secondary|Glucagon Area Under the Curve (AUC) (Fasting)|Pharmacokinetic parameter: Area under the glucagon concentration curve from 0 to 120 minutes|Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection|All randomized subjects who received at least one dose of study drug||(pg/ml)*hour||Standard Error|Mean
649451|NCT02081014|Secondary|Glucagon Cmax (Post-insulin)|Pharmacokinetic parameter: Maximum concentration of glucagon|Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection|All randomized subject who received at least one dose of study drug||pg/ml||Standard Error|Mean
649430|NCT02081365|Secondary|Change in Clinical Severity Rating for Specific Phobia Module of Anxiety Disorders Interview Schedule for DSM-IV|The Anxiety Disorders Interview Schedule for DSM-IV is a semi-structured diagnostic interview for assessing DSM-IV criteria for current anxiety, depressive, somatoform, and substance use disorders. For the present investigation, only the specific phobia module of the ADIS-IV was administered to assess the presence and severity of a current diagnosis of dental phobia. Various aspects of dental phobia were assessed using the specific phobia module of the ADIS-IV. Interviewers assessed participants’ anxiety and avoidance of dental procedures on scales that ranged from 0 (none) to 8 (very severe). They also rated patients’ overall distress and impairment due to their dental phobia symptoms and assigned a clinician’s severity rating (CSR) that also ranged from 0 (none) to 8 (very severe); a CSR > 4 indicated that the participant met criteria for diagnosis of dental phobia.|Change from one week before dental appointment to one-month after dental appointment|||units on a scale||Standard Error|Mean
649431|NCT02081365|Primary|Change in Modified Dental Anxiety Scale|The Modified Dental Anxiety Scale a five-item self-report measure that assesses fear of dental procedures, including drilling, scaling and polishing (i.e., cleaning), and local anesthetic injections. Sample items include, “If you went to your dentist for treatment tomorrow, how would you feel?” and “If you were about to have your tooth drilled, how would you feel?” Items are rated on a five-point Likert-type scale ranging from 1 (not anxious) to 5 (extremely anxious). Scale 0-25. We considered patients who scored > 19 on the MDAS at baseline or endorsed at least two MDAS items > 4 to have high dental anxiety.|Change from one week before dentist appointment to 1 month after dentist appointment|||units on a scale||Standard Error|Mean
649432|NCT02081183|Primary|Serum Albumin|Albumin is a protein made by the liver. A serum albumin test measures the amount of this protein in the clear liquid portion of the blood. Decreased serum albumin levels can be an indicator of liver and/or kidney disease, The normal range is 3.4 - 5.4 grams (g)/dL.|18 months|Data were not analyzed because the study was terminated early.|||||
649433|NCT02081183|Primary|Serum Creatinine|Serum creatinine is an indicator of kidney function. Creatinine is a substance formed from the metabolism of creatine, commonly found in blood, urine, and muscle tissue. It is removed from the blood by the kidneys and excreted in urine. An increased level of creatinine in the blood indicates decreased kidney function. Normal adult blood levels of creatinine are 0.5 to 1.1 mg/dL for females and 0.6 to 1.2 mg/dL for males, however the normal values are age-dependent as elderly participants typically have smaller muscle mass.|18 months|Data were not analyzed because the study was terminated early.|||||
649434|NCT02081183|Primary|Urinary Protein|Protein in urine is an indicator of kidney function. An increased urinary protein level indicates decreased kidney function. Normal values are approximately 0 to 8 milligrams per deciliter (mg/dL).|18 months|Data were not analyzed because the study was terminated early.|||||
649435|NCT02081183|Primary|Creatinine Clearance|Creatinine clearance in an indicator of kidney function. An increased level of creatinine in the blood indicates decreased kidney function. Normal adult values are 97 to 137 milliliters per minute (mL/min) for males and 88 to 128 mL/min for females.|18 months|Data were not analyzed because the study was terminated early.|||||
649436|NCT02081079|Secondary|Change From Baseline in HCV RNA at Weeks 2, 4, 8, and 12||Baseline; Weeks 2, 4, 8, and 12|Full Analysis Set||log10 IU/mL||Standard Deviation|Mean
649437|NCT02081079|Secondary|Percentage of Patients With Virologic Failure|"Virologic failure was defined as either:
On-treatment virologic failure:
Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment); or
Relapse:
HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment"|Up to posttreatment Week 24|Full Analysis Set||percentage of participants|||Number
649438|NCT02081079|Secondary|Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set||percentage of participants|||Number
649439|NCT02081079|Primary|Percentage of Participants Who Permanently Discontinued LDV/SOF Due to an Adverse Event||Up to 12 weeks|Safety Analysis Set: participants were enrolled and received at least 1 dose of study drug||percentage of participants|||Number
649440|NCT02081079|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants with genotype 4 or 5 HCV infection who were enrolled and received at least on dose of study drug.||percentage of participants|||Number
649441|NCT02081014|Secondary|Glucose Tmax (Post-insulin)|Pharmacodynamic parameter: Time to reach maximum concentration of glucose|Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection|All randomized subjects who received at least one dose of study drug||minutes||Standard Error|Mean
649442|NCT02081014|Secondary|Glucose Tmax (Fasting)|Pharmacodynamic parameter: Time to reach maximum concentration of glucose|Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 180 minutes post-injection|All randomized subjects who received at least one dose of study drug||minutes||Standard Error|Mean
649443|NCT02081014|Secondary|Glucose AUC (Post-insulin)|Pharmacodynamic parameter: baseline adjusted area under the glucose concentration curve from 0-120 minutes|Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection|All randomized subjects who received at least one dose of study drug||(mg/dl)*minutes||Standard Error|Mean
649444|NCT02081014|Secondary|Glucose AUC (Fasting)|Pharmacodynamic parameter: baseline adjusted area under the glucagon concentration curve from 0 to 120 minutes|Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection|All randomized subjects who received at least one dose of study drug||(mg/dl)*minutes||Standard Error|Mean
649445|NCT02081014|Secondary|Glucose Cmax (Post-insulin)|Pharmacodynamic parameter: Maximum concentration of glucose|Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection|All randomized subjects who received at least one dose of study drug||mg/dl||Standard Error|Mean
649469|NCT02080481|Secondary|Percentage of Time With Perfect Needle Visibility|Percentage of time that perfect needle visibility was visualized on ultrasound.|From start of block procedure until block placement|||percentage of time||Standard Deviation|Mean
649452|NCT02081014|Secondary|Glucagon Cmax (Fasting)|Pharmacokinetic parameter: Maximum concentration of glucagon|Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 180 minutes post-injection|All randomized subjects who received at least one dose of study drug||pg/ml||Standard Error|Mean
649453|NCT02081014|Primary|Serious Adverse Events|Number of serious adverse events (SAEs) per treatment|From first dose until follow-up call, up to 7 weeks per subject|All randomized subjects who received at least one dose of study drug||participants|||Number
649454|NCT02081001|Secondary|Infusion Site Discomfort Score at 30 Minutes|Infusion site discomfort was assessed by the subject using a 100 mm Visual Analog Scale (VAS) questionnaire at 30 minutes following the initiation of dosing. Subjects were asked to draw a vertical line across the horizontal scale to indicate their current level of discomfort from 0 = no discomfort to 100 = worst possible discomfort. The distance in mm from the left hand anchor to the the first point where the subject's mark crossed the horizontal scale was measured and reported as the infusion site discomfort score.|At 30 minutes post-dosing|All treated subjects||mm||Standard Deviation|Mean
649455|NCT02081001|Secondary|Infusion Site Discomfort Score at 10 Minutes|Infusion site discomfort was assessed by the subjects using a 100 mm Visual Analog Scale (VAS) questionnaire at 10 minutes following the initiation of dosing. Subjects were asked to draw a vertical line across the horizontal scale to indicate their current level of discomfort from 0 = no discomfort to 100 = worst possible discomfort. The distance in mm from the left hand anchor to the the first point where the subject's mark crossed the horizontal scale was measured and reported as the infusion site discomfort score.|At 10 minutes post-dosing|All treated subjects||mm||Standard Deviation|Mean
649456|NCT02081001|Secondary|Glucose AUC|Area under the plasma concentration time curve for glucose|From 0 to 150 minutes post-dosing|All randomized, evaluable subjects. Two subjects not evaluable for response to GlucaGen due to dosing errors were excluded from the analysis.||(mg/dl)*minutes||Standard Deviation|Mean
649457|NCT02081001|Secondary|Glucagon AUC|Area under the plasma concentration time curve for glucagon|From 0 to 150 minutes post-dosing|All randomized, evaluable subjects. Two subjects not evaluable for response to GlucaGen due to dosing errors were excluded from the analysis.||(pg/dl)*minutes||Standard Deviation|Mean
649458|NCT02081001|Secondary|Glucose Tmax|Time to maximum plasma concentration of glucose|From 0 to 150 minutes post-dosing|All randomized, evaluable subjects. Two subjects not evaluable for response to GlucaGen due to dosing errors were excluded from the analysis. In addition, subjects with no increase in glucose concentration post-dosing (i.e., maximum concentration was at time zero) were not evaluable for response and consequently were not included in the analysis.||minutes||Standard Deviation|Mean
649459|NCT02081001|Secondary|Glucagon Tmax|Time to maximum plasma concentration of glucagon|From 0 to 150 minutes post-dosing|All randomized, evaluable subjects. Two subjects not evaluable for response to GlucaGen due to dosing errors were excluded from the analysis.||minutes||Standard Deviation|Mean
649460|NCT02081001|Secondary|Glucose Cmax|Maximum plasma concentration of glucose|From 0 to 150 minutes post-dosing|All randomized, evaluable subjects. Two subjects not evaluable for response to GlucaGen due to dosing errors were excluded from the analysis.||mg/dl||Standard Deviation|Mean
649461|NCT02081001|Secondary|Glucagon Cmax|Maximum plasma concentration of glucagon|From 0 to 150 minutes post-dosing|All randomized, evaluable subjects. Two subjects not evaluable for response to GlucaGen due to dosing errors were excluded from the analysis.||pg/dl||Standard Deviation|Mean
649462|NCT02081001|Primary|Time to Reach 50% of Maximum Glucagon Concentration (Glucagon T50%-Early)|The speed of absorption was assessed by determining the time in minutes required to achieve 50% of the maximum plasma concentration of glucagon following each dose of glucagon.|0 to 150 minutes post-dosing|All randomized, evaluable subjects. Two subjects not evaluable for response to GlucaGen due to dosing errors were excluded from the analysis.||minutes||Standard Deviation|Mean
649463|NCT02081001|Primary|Time to Reach 50% of Maximum Glucose Concentration (Glucose T50%-Early)|The onset of action was assessed by determining the time in minutes required to achieve 50% of the maximum plasma concentration of glucose following each dose of glucagon.|0 to 150 minutes post-dosing|All randomized, evaluable subjects. Two subjects not evaluable for response to GlucaGen due to dosing errors were excluded from the analysis. In addition, subjects with no increase in glucose concentration post-dosing (i.e., maximum concentration was at time zero) were not evaluable for response and consequently were not included in the analysis.||minutes||Standard Deviation|Mean
649464|NCT02080780|Primary|Peak Plasma Concentration (Cmax) of 2% Diltiazem|To evaluate the drug-drug interaction potential of clarithromycin XL on Diltiazem hydrochloride (DTZ) 2% cream.|9 days|||ng / mL||Standard Deviation|Mean
649465|NCT02080546|Secondary|Incidence of Clinical Surrogates of Compromised Vaginal Cuff Healing|a difference between arms in the proportion of patients who have at least one of the following post-operatively: vaginal vault granulation tissue, vaginal cuff separation/dehiscence, or vaginal apex infection|4 weeks, 3 months, and 6 months after hysterectomy for a post-operative check and pelvic examination|This secondary objective was not evaluated||participants||95% Confidence Interval|Number
649466|NCT02080546|Primary|Degree of Thermal Injury at the Time of Laparoscopic Hysterectomy|"distance in millimeters over which thermal tissue injury extends (henceforth referred to as injury)."|up to 36 months|49 participants were included in the cut/coag arm and 52 participants in the V mode arm. Thermal injury was assessed at the anterior margin in 91 specimens and at the posterior margin in 93 specimens.||mm|Participants|Full Range|Mean
649467|NCT02080507|Secondary|Quality of Life Assessed by the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-Les-SF) Score|The Q-Les-SF assesses the degree of enjoyment and satisfaction experienced by individuals in various areas of daily functioning. The minimum raw score is 14, and the maximum score is 70. Higher scores indicate better satisfaction with life domains (physical health, feelings, work, household duties, school/course work, leisure time activities, and social relations).|Baseline, Week 6|||units on a scale||Standard Deviation|Mean
649468|NCT02080507|Primary|Depression Severity as Assessed by the Montgomery Åsberg Depression Rating Scale (MADRS) Score|The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. The MADRS-S instrument has nine questions, with an overall score ranging from 0 to 60 points. A higher score indicates greater depressive symptoms.|Baseline, Week 6|||units on a scale||Standard Deviation|Mean
661775|NCT01833988|Secondary|Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Mean CGMG at Night|Day 2-5|Day 2-5|||mg/dl||Standard Deviation|Mean
649472|NCT02080481|Primary|Time Spent in Performing Ultrasound Guided Femoral Nerve Blocks With InfinitiPlusTM Needle Guidance System||time elapsed from beginning the block procedure (after prepping and draping) until the catheter was successfully inserted or the end of the day of surgery.|||seconds||Inter-Quartile Range|Median
649473|NCT02080312|Secondary|Extension of Contrast From Perilymph to CSF|The fundus of the internal auditory canal (IAC) was visually inspected to determine if there was conspicuous, subtle, or no enhancement extending in the setting of prior IT contrast injection, indicating permeability of the cochlear modiolus.|24 hours post injection|||participants|||Number
649474|NCT02080312|Primary|"Cochlear Endolymphatic Hydrops (EH)"|The relative volume of the scala media of the basal turn of the cochlea (non-enhancing endolymph) was visually assessed relative to the scala tympani and scala vestibuli (enhancing perilymph) on delayed post-IT contrast FLAIR MRI sequences. Cases were characterized as: No Cochlear EH (no perceptible distention of the scala media), Cochlear EH (perceptible distention of the scala media), or Absent enhancement (no contrast in the cochlear perilymph)|24 hours post injection|||participants|||Number
649475|NCT02080312|Primary|"Vestibular Endolymphatic Hydrops (EH)"|The relative volume of the non-enhancing endolymphatic space was visually assessed relative to the enhancing perilymphatic space on delayed post-IT contrast FLAIR MRI sequences and characterized as <34%, 34-50% or >50% of endolymphatic/perilymphatic volume.|24 hours post injection|||participants|||Number
649476|NCT02080091|Secondary|Retinal Center Subfield Thickness|Observed and change from baseline SD-OCT values will be summarized using descriptive statistics.|24 months|23 Patients received ILUVIEN, one patient was treated bilaterally||microns|Participants|Standard Deviation|Mean
649477|NCT02080091|Primary|Number of Patients With Ocular Adverse Events||24 Months|23 Patients received ILUVIEN, one patient was treated bilaterally||participants|Participants||Number
649478|NCT02080091|Primary|Visual Acuity|Observed and change from baseline visual acuity LogMAR scores will be summarized using descriptive statistics.|24 Months|23 Patients received ILUVIEN, one patient was treated bilaterally||LogMAR|Participants|Standard Error|Mean
649479|NCT02079844|Secondary|Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurement|Vital signs were oral body temperature, respiration rate, supine blood pressure (after 5 minutes resting), and pulse rate.|From Day 1 until Day 63|Safety population, including all randomized participants who received at least 1 dose of study drug and completed the vital sign tests on Day 8 of each treatment period.||percentage of participants|||Number
649480|NCT02079844|Secondary|Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests|Percentage of participants with markedly abnormal safety laboratory tests (Hematology, Serum Chemistry and Urinalysis) collected throughout the study.|From Day 1 until Day 63|Safety population, including all randomized participants who received at least 1 dose of study drug and completed the laboratory tests during treatment.||percentage of participants|||Number
649481|NCT02079844|Secondary|Percentage of Participants Who Experience at Least 1 Treatment-Emergent Adverse Event|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|From Day 1 until Day 63|Safety population included all randomized participants who received at least 1 dose of study drug.||percentage of participants|||Number
649482|NCT02079844|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score|PANSS assesses the positive symptoms, negative symptoms, and general psychopathology associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Positive subscale consists of 7 items which assesses the positive symptoms with subscale score ranging from 7 to 49, where higher score indicates greater severity. Negative subscale consists of 7 items which assesses the negative symptoms with subscale score ranging from 7 to 49, where higher score indicates greater severity. General psychopathology subscale consists of 16 items which assesses the general symptoms of schizophrenia with subscale score ranging from 16 to 96, where higher score indicates greater severity. A negative change from Baseline indicates improvement. ANOVA with treatment sequence, study period and treatment group as fixed effects and participant nested within treatment sequence as a random effect was used for analysis.|Baseline and Day 8 of Treatment Periods 1, 2 and 3|Participants from the Pharmacodynamic Analysis Set, all randomized participants who received at least 1 dose of study drug and had at least 1 pharmacodynamic result post-dose, with data available for analysis at Baseline and Day 8.||score on a scale||Standard Error|Least Squares Mean
649483|NCT02079844|Secondary|Change From Baseline in Frontal Theta Power (EEG) During N-Back Working Memory Task|EEG, a test that measures brain electrical activity, was performed during the n-back task. In the n-back task participants are required to monitor a series of letters and report when the current letter matches the letter n integers back, where n=1 (1-back) or n=2 (2-back), the latter requiring a greater working memory resources. The task requires continuous updating of information stores. In the 0-back condition (which does not require manipulation of material in working memory), participants respond to the appearance of a pre-specified letter. The task consists of alternating 30-second (s) blocks of 0-back with 1-back, and 2-back conditions, with letters displayed every 2 s for 1 s within each block. A positive change from Baseline indicates improvement. ANOVA with treatment sequence, study period, and treatment as fixed effects and subject nested within treatment sequence as a random effect was used for analysis.|Baseline and Day 8 of Treatment Periods 1, 2 and 3|Participants from the Pharmacodynamic Analysis Set, all randomized participants who received at least 1 dose of study drug and had at least 1 pharmacodynamic result post-dose, with data available for analysis at Baseline and Day 8.||μV||Standard Error|Least Squares Mean
649490|NCT02079844|Secondary|Change From Baseline in Category Fluency Animal Naming Scores|The Category Fluency test assesses the participant's speed of processing. The test is administered orally, with the participant naming as many animals as he can in 1 minute. The key outcome variable for the test is the total number of correct, valid category words in 60 seconds. A positive change from Baseline indicates improvement. ANOVA with treatment sequence, study period, and treatment as fixed effects and participant nested within treatment sequence as a random effect.|Baseline and Day 8 of Treatment Periods 1, 2 and 3|Participants from the Pharmacodynamic Analysis Set, all randomized participants who received at least 1 dose of study drug and had at least 1 pharmacodynamic result post-dose, with data available for analysis.||correct words||Standard Error|Least Squares Mean
649484|NCT02079844|Secondary|Change From Baseline in High Beta/Low Gamma Power During Resting EEG|Participants are asked to open and close their eyes in 30 second alternating blocks to maintain an approximately constant level of arousal. The eyes closed EEG, a test that measures brain electrical activity, is dominated by alpha (8-14Hz) and the eyes open EEG dominated by beta (14-30Hz eyes open) with the two states analyzed separately to increase sensitivity to drug effects in these bands. Ratio is calculated as High Beta/Low Gamma Power. A positive change from Baseline indicates improvement. ANOVA with treatment sequence, study period, and treatment as fixed effects and subject nested within treatment sequence as a random effect.|Baseline and Day 8 of Treatment Periods 1, 2 and 3|Participants from the Pharmacodynamic Analysis Set, all randomized participants who received at least 1 dose of study drug and had at least 1 pharmacodynamic result post-dose, with data available for analysis at Baseline and Day 8.||ratio||Standard Error|Least Squares Mean
649485|NCT02079844|Secondary|Change From Baseline in Amplitude of the C1 Component of the Visual Evoked Potentials at the Midline Occipital Electrode (Oz)|EEG, a test that measures brain electrical activity was used. Participants had a baseline Visual Evoked Potentials (VEP) recording (2 minute checkerboard VEP) followed by a period of high frequency stimulation (2 minutes 9 Hz checkerboard stimulation). The VEP was repeated 2 minutes after the end of high frequency stimulation. A positive change from Baseline indicates improvement. ANOVA with treatment sequence, study period, and treatment as fixed effects and subject nested within treatment sequence as a random effect was used for analysis.|Baseline and Day 8 of Treatment Periods 1, 2 and 3|Participants from the Pharmacodynamic Analysis Set, all randomized participants who received at least 1 dose of study drug and had at least 1 pharmacodynamic result post-dose, with data available for analysis.||μV||Standard Error|Least Squares Mean
649486|NCT02079844|Secondary|Change From Baseline in Mismatch Negativity (MMN) Amplitude at the Midline Frontal Electrode (Fz)|EEG, a test that measures brain electrical activity was performed during the MMN. The MMN is an auditory event related potential that is elicited by any discriminable change in auditory stimulation irrespective of the participant or participant's attention. The response to stimuli is being recorded by EEG electrodes while participants read a book. A positive change from Baseline indicates improvement. ANOVA with treatment sequence, study period, and treatment as fixed effects and subject nested within treatment sequence as a random effect was used for analysis.|Baseline and Day 8 of Treatment Periods 1, 2 and 3|Participants from the Pharmacodynamic Analysis Set, all randomized participants who received at least 1 dose of study drug and had at least 1 pharmacodynamic result post-dose, with data available for analysis at Baseline and Day 8.||μV||Standard Error|Least Squares Mean
649487|NCT02079844|Secondary|Change From Baseline in P300 Amplitude at the Midline Parietal Electrode (Pz)|"Brain electrical activity changes were quantified with electroencephalogram (EEG) battery tests. The P300 occurs after the presentation of a novel, behaviorally relevant target stimulus embedded among irrelevant stimuli. It reflects allocation of attention and activation of immediate memory.
The amplitude of P300 indexes brain actions when the mental representation of the stimulus environment is updated, while its latency indexes stimulus classification speed unrelated to response selection processes. The participants are instructed to push a button when hearing the target stimulus, but not when hearing the standard. They are asked to press the button as fast as possible. A positive change from Baseline indicates improvement. ANOVA with treatment sequence, study period, and treatment as fixed effects and subject nested within treatment sequence as a random effect was used for analysis."|Baseline and Day 8 of Treatment Periods 1, 2 and 3|Participants from the Pharmacodynamic Analysis Set, all randomized participants who received at least 1 dose of study drug and had at least 1 pharmacodynamic result post-dose, with data available for analysis at Baseline and Day 8.||microvolts (μV)||Standard Error|Least Squares Mean
649488|NCT02079844|Secondary|Ventral Striatum Activation During the Reward Trials|"BOLD fMRI, a test that measures brain activity, was used during the Reward Task (Monetary Incentive Delay Test). Participants were instructed to respond as quickly as possible to a light-flash on the display screen. The flash was preceded by an arrow icon that informed participants about the consequences of their response to the flash stimulus. Four conditions were included in the paradigm, as follows:
Win condition (arrow up): win 2 pound sterling if the response was sufficiently fast.
Avoidance of loss condition (arrow down: lose 2 pound sterling if the response was too slow.
Verbal control (vertical double arrow): no gain or loss of money.
Passive control condition (horizontal double arrow): No response was required. Each of the above conditions was presented at least 10 times in a random order. ANOVA with treatment sequence, study period, and treatment as fixed effects and participant nested within treatment sequence as a random effect was used for analysis."|Baseline and Day 8 of Treatment Periods 1, 2 and 3|Participants from the Pharmacodynamic Analysis Set, all randomized participants who received at least 1 dose of study drug and had at least 1 pharmacodynamic result post-dose, with data available for analysis.||unitless parameter estimates||Standard Error|Least Squares Mean
649489|NCT02079844|Secondary|Ventrolateral Prefrontal (VLPF) Cortex and Orbitofrontal (OFX) Cortex Activation During the Shift Trials|BOLD fMRI, a test that measures brain activity, was used during the Shifting Task at VLPF and OFX. Participants worked out which pair in a stimulus set consisting of a face and a building; transparent and overlapping, was the target. 1 pair appeared on the left of the screen, the other on the right. In each trial, participants indicated using a button box which side of the screen they thought the target was located on. Every second response, feedback was presented on the screen for 0.6 seconds, indicating whether or not the stimulus chosen was the target. If both of the last 2 choices were correct, the feedback was the word ‘‘correct’’ in green; otherwise, the feedback was the word ‘‘incorrect’’ in red. After 3 positive feedback events, a change of target occurred. A positive change from Baseline indicates improvement. ANOVA with treatment sequence, study period, and treatment as fixed effects and participant nested within treatment sequence as a random effect was used for analysis.|Baseline and Day 8 of Treatment Periods 1, 2 and 3|Participants from the Pharmacodynamic Analysis Set, all randomized participants who received at least 1 dose of study drug and had at least 1 pharmacodynamic result post-dose, with data available for analysis.||unitless parameter estimates||Standard Error|Least Squares Mean
649501|NCT02079805|Secondary|Change in Fasting Blood Glucose From Baseline at the End of the Treatment Period (Week 12)|Change from baseline in fasting blood glucose values collected at week 12 or final visit relative to baseline was reported.|Baseline and Week 12|The full analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period.||mg/dL||Standard Deviation|Mean
649491|NCT02079844|Secondary|Change From Baseline in Brief Assessment of Cognition in Schizophrenia: Symbol-Coding|The Brief Assessment of Cognition in Schizophrenia (BACS): Symbol-Coding assesses the participant's speed of processing. The test is a timed paper-and-pencil test in which the participant uses a key to write digits that correspond to nonsense symbols. The key outcome variable for this task is the total number of correct, valid symbols in 90 seconds. A positive change from Baseline indicates improvement. ANOVA with treatment sequence, study period and treatment group as fixed effects and participant nested within treatment sequence as a random effect.|Baseline and Day 8 of Treatment Periods 1, 2 and 3|Participants from the Pharmacodynamic Analysis Set, all randomized participants who received at least 1 dose of study drug and had at least 1 pharmacodynamic result post-dose, with data available for analysis.||correct symbols||Standard Error|Least Squares Mean
649492|NCT02079844|Secondary|Change From Baseline in the Continuous Performance Test (CPT)|The CPT is a computerized test that assesses the participant’s attention and vigilance. The participant was asked to attend to digits flashing on a computer screen and to click the mouse when the same string of digits flashed consecutively. The test consisted of 3 trials: the first contained 2-digit sequences, the second contained 3-digit sequences, and the third contained 4-digit sequences. Scoring was based the number of correct hits. The total score was an average of the 3 trials. A positive change from Baseline indicates improvement. ANOVA with treatment sequence, study period, and treatment as fixed effects and subject nested within treatment sequence as a random effect was used for analysis.|Baseline and Day 8 of Treatment Periods 1, 2 and 3|Participants from the Pharmacodynamic Analysis Set, all randomized participants who received at least 1 dose of study drug and had at least 1 pharmacodynamic result post-dose, with data available for analysis.||correct hits||Standard Error|Least Squares Mean
649493|NCT02079844|Primary|Dorsolateral Prefrontal Cortex Activation During the Rewarded Delayed Response Working Memory|BOLD Functional magnetic resonance imaging (fMRI) changes in the blood-oxygen-level-dependent (BOLD) - signal, which changes in response to neural activity. Baseline fMRI measurements will be followed by rewarded delayed response Working Memory (WM) task measurements in which participants are required to remember the spatial location of a target stimulus (a dot) relative to a fixation cross. Participants are given feedback indicating success or failure. ANOVA with treatment sequence, study period, and treatment as fixed effects and participant nested within treatment sequence as a random effect.|Baseline and Day 8 of Treatment Periods 1, 2 and 3|Participants from the Pharmacodynamic Analysis Set, all randomized participants who received at least 1 dose of study drug and had at least 1 pharmacodynamic result post-dose, with data available for analysis.||unitless parameter estimates||Standard Error|Least Squares Mean
649494|NCT02079844|Primary|Change From Baseline in Hopkins Verbal Learning Test (HVLT) Score|The HVLT assesses the participant's verbal learning. The test consists of a list of 12 words from three taxonomic categories which are presented orally, and the participant is asked to recall as many as possible after each of three learning trials. The key outcome variable for this task is the total correct responses in the three learning trials. A positive change from Baseline indicates improvement. ANOVA with treatment sequence, study period, and treatment as fixed effects and participant nested within treatment sequence as a random effect was used for analysis.|Baseline and Day 8 of Treatment Periods 1, 2 and 3|Participants from the Pharmacodynamic Analysis Set, all randomized participants who received at least 1 dose of study drug and had at least 1 pharmacodynamic result post-dose, with data available at both Baseline and Day 8 for analysis.||correct responses||Standard Error|Least Squares Mean
649495|NCT02079844|Primary|Change From Baseline in Spatial Span Test Score|The Spatial Span test assesses the participant’s working memory. During this task, participants are presented with a board containing blue blocks randomly arranged. The rater first taps out a pattern of blocks, beginning with two blocks and increasing with participant proficiency, and the participant is tasked with tapping the same pattern. After discontinuation of this part of the subtest, the participant is then tasked with tapping out the reverse pattern after the rater's demonstration. These patterns also begin with two blocks and increase with participant proficiency. The total score for this subtest ranges from 0 (worst) to 32 (best). A positive change from Baseline indicates improvement. Analysis of Variance (ANOVA) with treatment sequence, study period, and treatment as fixed effects and participant nested within treatment sequence as a random effect was used for analysis.|Baseline and Day 8 of Treatment Periods 1, 2 and 3|Participants from the Pharmacodynamic Analysis Set, all randomized participants who received at least 1 dose of study drug and had at least 1 pharmacodynamic result post-dose, with data available at both Baseline and Day 8 for analysis.||score on a scale||Standard Error|Least Squares Mean
649496|NCT02079805|Secondary|Number of Participants With Treatment-Emergent Adverse Events||Up to Week 12|The safety analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period.||participants|||Number
649497|NCT02079805|Secondary|Change in 1,5-anhydroglucitol (1,5-AG) From Baseline at the End of the Treatment Period (Week 12)|Change from baseline in 1,5-G concentration collected at week 12 or final visit relative to baseline was reported.|Baseline and Week 12|The full analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period.||μg/mL||Standard Deviation|Mean
649498|NCT02079805|Secondary|Change in Homeostasis Model Assessment of Beta Cell Function (HOMA-β) From Baseline at the End of the Treatment Period (Week 12)|Change from baseline in HOMA-β collected at week 12 or final visit relative to baseline was reported. Homeostasis model assessment of beta cell function measures as following; HOMA-β = fasting insulin (μU/mL) ×360/{fasting glucose (mg/dL) - 63}.|Baseline and Week 12|The full analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period.||percent||Standard Deviation|Mean
649499|NCT02079805|Secondary|Change in Glycosylated Hemoglobin (HbA1c) From Baseline at the End of the Treatment Period (Week 12)|Change from baseline in the values of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 or final visit relative to baseline was reported.|Baseline and Week 12|The full analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period.||percent||Standard Deviation|Mean
649500|NCT02079805|Secondary|Change in Fasting Insulin From Baseline at the End of the Treatment Period (Week 12)|Change from baseline in fasting insulin values collected at week 12 or final visit relative to baseline was reported.|Baseline and Week 12|The full analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period.||µU/mL||Standard Deviation|Mean
649502|NCT02079805|Primary|Change in Insulin Resistance Index (HOMA-R) From Baseline at the End of the Treatment Period (Week 12)|Change from the start of the treatment period (baseline) at the end of the treatment period (Week 12) was reported. Insulin Resistance Index (HOMA-R) measures insulin resistance, calculated by fasting insulin (μU/mL) multiplied by fasting glucose (mg/dL), and divided by a constant (405).|Baseline and Week 12|The full analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period.||HOMA-R Score||Standard Deviation|Mean
649503|NCT02079649|Secondary|Mean Change From Baseline in Ocular Itching, Area Under the Curve From Time Zero to Hour 10 [AUC (0-10)] at Day 7|Ocular itching was assessed by the subject with both eyes rated together and scored on a scale from 0 (none) to 4 (incapacitating itch with irresistible urge to rub). AUC was calculated using the trapezoidal rule with unequal intervals as determined by the assessment time points. Change was calculated as AUC(0-10)[Day 7] - AUC(0-10) [Baseline].|0.0, 0.25, 0.50, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, and 10.0 hours on Days 1 (baseline) and 7|This analysis population includes all randomized subjects who had a baseline evaluation minus those who had important protocol deviations that could have affected the outcome of the study.||hours x units on a scale||Standard Error|Mean
649504|NCT02079649|Primary|Mean Change From Baseline in Ocular Redness, Area Under the Curve From Time Zero to Hour 10 [AUC (0-10)] at Day 7|Ocular redness ratings were collected for nasal and temporal areas of each eye and assessed by investigational center staff using a visual scale (ie, scored by comparing the subject's eye with a series of photographs) and graded on a scale from 0 (none) to 4 (extremely severe), 0.5 unit steps permitted. AUC was calculated using the trapezoidal rule with unequal intervals as determined by the assessment time points. Change was calculated as AUC(0-10)[Day 7] - AUC(0-10) [Baseline]. Both eyes contributed to the analysis.|0.0, 0.25, 0.50, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, and 10.0 hours on Days 1 (baseline) and 7|This analysis population includes all randomized subjects who had a baseline evaluation minus those who had important protocol deviations that could have affected the outcome of the study.||hours x units on a scale||Standard Error|Mean
649505|NCT02079610|Secondary|Change From Baseline Hamilton Rating Scale for Depression at 2 Weeks|"Depression symptom severity rating scale. The overall score ranges on HDRS are from from 0 to 50, with higher scores indicating more severe depression. Usual cutoff points are:
0 to 7 – normal /symptom absent 8 to 16 – mild depression 17 to 23 – moderate depression >24 – severe depression"|baseline and 2 weeks|One participant in each group did not complete all study visits||units on a scale||Standard Deviation|Mean
649506|NCT02079610|Secondary|Change From Baseline Beck Depression Inventory at 2 Weeks|"Depression symptom severity rating scale. The overall score ranges on BDI are from from 0 to 63, with higher scores indicating more severe depression. Usual cutoff points are:
0 to 13 – normal /symptom absent 14 to 19 – mild depression 20 to 28 – moderate depression >29 – severe depression"|baseline and 2 weeks|One participant in each group did not complete all study visits||units on a scale||Standard Deviation|Mean
649507|NCT02079610|Primary|Change From Baseline in Montgomery Asberg Depression Rating Scale at 2 Weeks|"Depression symptom severity rating scale. The overall score ranges on MADRS are from from 0 to 60, with higher scores indicating more severe depression. Usual cutoff points are:
0 to 6 – normal /symptom absent 7 to 19 – mild depression 20 to 34 – moderate depression >34 – severe depression"|baseline and 2 weeks|1 participant in each group did not complete all study visits||units on a scale||Standard Deviation|Mean
649508|NCT02079532|Secondary|Rheumatoid Factor (RF)|Mean RF as measured by international unit per milliliter (IU/mL) at screening and Weeks 8, 16, and 24.|Screening and Weeks 8, 16, and 24|ITT population; n=number of participants assessed at a given visit.||IU/mL||Standard Deviation|Mean
649509|NCT02079532|Secondary|Erythrocyte Sedimentation Rate (ESR)|Mean ESR, as an acute phase reactant, measured in mm/hr at screening, Days 1 and 15, and Weeks 8, 16, and 24.|Screening, Days 1 and 15, and Weeks 8, 16, and 24|ITT population; n=number of participants assessed at a given visit.||mm/hr||Standard Deviation|Mean
649510|NCT02079532|Secondary|C-Reactive Protein (CRP)|Mean CRP as measured as an acute phase reactant by mg per deciliter (mg/dL) at screening, Days 1 and 15, and Weeks 8, 16, and 24.|Screening, Days 1 and 15, and Weeks 8, 16, and 24|ITT population; n=number of participants assessed at a given visit.||mg/dL||Standard Deviation|Mean
649511|NCT02079532|Secondary|Patient's Assessment of Pain|Participants were to assess their current level of pain on a 100 mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as “no pain” and the right-hand (100 mm) as “unbearable pain”.|Screening and Weeks 8, 16, and 24|ITT population; n=number of participants assessed at a given visit.||mm||Standard Deviation|Mean
649512|NCT02079532|Secondary|Patient's Assessment of Disease Activity|Participants were to assess the disease (RA) activity on a 100 mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as “no disease activity” (symptom-free and no arthritis symptoms) and the right hand extreme (100 mm) as “maximum disease activity” (maximum arthritis disease activity).|Screening and Weeks 8, 16, and 24|ITT population; n=number of participants assessed at a given visit.||mm||Standard Deviation|Mean
649513|NCT02079532|Secondary|Physician's Global Assessment of Disease Activity|Physicians assessed the disease (RA) activity on a 100 mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as “no disease activity” (symptom-free and no arthritis symptoms) and the right hand extreme (100 mm) as “maximum disease activity” (maximum arthritis disease activity).|Screening and Weeks 8, 16, and 24|ITT population; n=number of participants assessed at a given visit.||mm||Standard Deviation|Mean
649514|NCT02079532|Secondary|Tender Joint Count (TJC)|The 28 joints to be assessed for tenderness and swelling were shoulder, elbow, wrist, metacarpophalangeal (MCP) joints 1-5, proximal interphalangeal (PIP) joints 1-5, and knee on both sides of the body. The sum of tender joints ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status.|Screening and Weeks 8, 16, and 24|ITT population; n=number of participants assessed at a given visit.||tender joints||Standard Deviation|Mean
649515|NCT02079532|Secondary|Swollen Joint Count (SJC)|The 28 joints to be assessed for tenderness and swelling were shoulder, elbow, wrist, metacarpophalangeal (MCP) joints 1-5, proximal interphalangeal (PIP) joints 1-5, and knee on both sides of the body. The sum of swollen joints, each, ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status.|Screening and Weeks 8, 16, and 24|ITT population; n=number of participants assessed at a given visit.||swollen joints||Standard Deviation|Mean
649618|NCT02075073|Primary|Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)||57 days|||µg·h/mL||Standard Deviation|Mean
649516|NCT02079532|Secondary|Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Percent (%), 50% or 70% Response (ACR20/ACR50/ACR70)|ACR20/50/70 response: ≥20%, ≥50%, or ≥70% improvement, respectively, in tender or swollen joint counts and ≥20%, ≥50%, or ≥70% improvement, respectively, in 3 of the following 5 criteria: 1) Physician's Global Assessment of Disease Activity, 2) Patient's Global Assessment of Disease Activity, 3) Patient's Assessment of Pain, 4) participant assessment of functional disability via a HAQ-DI, and 5) C-reactive protein or ESR at each visit.|Weeks 8, 16, and 24|ITT population||percentage of participants|||Number
649517|NCT02079532|Secondary|SF-36 Domain Scores|The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to two distinct higher-ordered clusters: the physical and mental composite t-scores (PCS and MCS). The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.|Screening and Weeks 8, 16, and 24|ITT population; n=number of participants assessed at a given visit.||scores on a scale||Standard Deviation|Mean
649518|NCT02079532|Secondary|Short-Form 36 (SF-36) Physical Composite Scores (PCS) and Mental Composite Scores (MCS)|The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the physical and mental composite t-scores (PCS and MCS). The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.|Screening and Weeks 8, 16, and 24|ITT population; n=number of participants assessed at a given visit.||scores on a scale||Standard Deviation|Mean
649519|NCT02079532|Secondary|Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score|The FACIT fatigue scale is base on a 13-item questionnaire to assess the therapy-induced fatigue. Participants were requested to score each question on a scale ranging from 0 (best) to 4 (worst). The scoring system of the FACIT fatigue scale adds up to a total scale ranging from 0 (best) to 52 (worst). The assessment was originally developed for chronic illnesses and is now validated for patients with rheumatoid arthritis (RA). The questionnaire was provided in a German translation.|Screening and Weeks 8, 16, and 24|ITT population; n=number of participants assessed at a given visit.||scores on a scale||Standard Deviation|Mean
649520|NCT02079532|Secondary|Health Assessment Questionnaire - Disability Index (HAQ-DI) Score|The HAQ-DI score consists of questions referring to 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. For each of the categories, participants reported the amount of difficulty they had in performing 2 or 3 specific sub-category items. The standard disability score was calculated from the 8 categories by dividing the sum of the individual categories by the number of categories answered, yielding a score from 0 (without any difficulty) to 3 (unable to do).|Screening and Weeks 8, 16, and 24|ITT population; n=number of participants assessed at a given visit.||scores on a scale||Standard Deviation|Mean
649521|NCT02079532|Secondary|Percentage of Participants Achieving a Response By EULAR Category|Percentage of participants achieving a response by EULAR category, including 'moderate', 'good', or no response at follow-up Weeks 8, 16, and 24. The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders had a change from baseline >1.2 with a DAS28 score ≤ 3.2; moderate responders had a change from baseline >1.2 with a DAS28 score of >3.2 to ≤5.1 or a change from baseline >0.6 to ≤1.2 with a DAS28 score of ≤5.1; non-responders had a change from baseline ≤0.6 or change from baseline >0.6 and ≤1.2 with a DAS28 score of >5.1.|Weeks 8, 16, and 24|ITT population||percentage of participants|||Number
649522|NCT02079532|Secondary|Percentage of Participants Achieving Remission (DAS28 <2.6) at Week 24|Percentage of participants with remission defined as DAS28 <2.6 at follow-up Week 24. The DAS28 consists of SJC and TJC measurements, the ESR in mm/hr, and the Patient’s Global Assessment of Disease Activity (participant rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|Week 24|ITT population||percentage of participants|||Number
649523|NCT02079532|Secondary|Percentage of Participants With Low Disease Activity (DAS28 ≤3.2) at Week 24|Percentage of participants with low disease activity defined as DAS28 ≤3.2 at follow-up Week 24. The DAS28 consists of SJC and TJC measurements, the ESR in mm/hr, and the Patient’s Global Assessment of Disease Activity (participant rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity).|Week 24|ITT population||percentage of participants|||Number
649524|NCT02079532|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Response of Good or Moderate|The DAS28-based EULAR response criteria were used to measure individual responses as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders experienced a change from baseline of >1.2 with a DAS28 score ≤3.2 and moderate responders experienced a change from baseline >1.2 with DAS28 >3.2 to ≤5.1 or a change from baseline >0.6 to ≤1.2 with a DAS28 score of ≤5.1.|Weeks 8, 16, and 24|ITT population; n=number of participants assessed at a given visit||percentage of participants|||Number
649525|NCT02079532|Secondary|DAS28 Score|The DAS28 consists of SJC and TJC measurements, the ESR in mm/hr, and the Patient’s Global Assessment of Disease Activity (participant-rated RA assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|Screening and Weeks 8, 16, and 24|ITT population; n (number) = number of participants assessed at a given visit.||scores on a scale||Standard Deviation|Mean
649619|NCT02075021|Secondary|the Number of Patients Who Achieve Complete Response (CR) or Partial Response (PR) (Phase II)|The response will be determined using the International Uniform Response Criteria for Multiple Myeloma.|up to 2 years|Results were not analyzed due to lack of sufficient data. PI left the institution.|||||
649526|NCT02079532|Primary|Change From Baseline to Week 24 in Disease Activity Score Based on 28-Joint Count (DAS28)|The DAS28 consists of swollen joint count (SJC) and tender joint count (TJC) measurements, the erythrocyte sedimentation rate (ESR) in millimeters per hour (mm/hr), and the Patient’s Global Assessment of Disease Activity (participant-ated rheumatoid arthritis [RA] activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 less than or equal to (≤)3.2 equals (=) low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity.|Week 24|Intent to Treat (ITT) population: all participants who signed informed consent, received at least 1 dose of study drug, and where DAS28 was measured at least once under study medication (Weeks 8, 16, or 24 or unscheduled or withdrawal visit up to Week 24); those with no RA or no DAS28 score at screening were excluded, regardless if treated or not.||scores on a scale||Standard Deviation|Mean
649527|NCT02079519|Secondary|Overall Survival|Overall survival was defined as the time from the first dose of study medication until death.|Baseline to the end of the study (up to 1 year)||||||
649528|NCT02079519|Secondary|Progression-free Survival|Progression-free survival was defined as the time from the first dose of study drug to disease progression or death due to progression.|Baseline to the end of the study (up to 1 year)||||||
649529|NCT02079519|Primary|Percentage of Participants With a Complete Response or a Partial Response|A complete response was defined as the disappearance of the original monoclonal protein from the blood and urine on at least 2 determinations 6 weeks apart; < 5% plasma cells in the bone marrow on at least 2 determinations 6 weeks apart; if a skeletal survey is available, no increase in the size or number of lytic bone lesions; and the disappearance of soft tissue plasmacytomas for at least 6 weeks. A partial response was defined as a ≥ 50% reduction of monoclonal protein in the blood on at least 2 determinations 6 weeks apart; if present, reduction in 24-hour urinary light chain excretion by either ≥ 90% or to < 200 mg for at least 2 determinations 6 weeks apart; ≥ 50% reduction in the size of tissue plasmacytomas for at least 6 weeks; and if a skeletal survey is available, no increase in the size or number of lytic bone lesions.|Baseline to the end of the study (up to 1 year)|Intent-to-treat population: All participants who received at least 1 dose of study drug.||Percentage of participants|||Number
649530|NCT02079311|Primary|The Difference in Core Body Temperature in the Two Treatment Groups.|Temperature assessments will be made using an oesophageal temperature probe when the subject is under general anaesthesia and by oral thermometer for all other temperature assessments performed in pre-, intra- and post-op. The mean value is calculated on all temperature measured during pre-, intra- and post-op.|Subjects will be followed for one day of hospital stay, data to be collected during the perioperative phase. Expected to be between 5-8 hours.|||degree celsius||Standard Deviation|Mean
649531|NCT02078492|Secondary|Adverse Effect of Headache|The number of study patients who reported headache after administration of medication|120 minutes|||Participants|||Count of Participants
649532|NCT02078492|Secondary|Adverse Effect of Nausea|The number of study patients who reported nausea after administration of medication|120 minutes|||Participants|||Count of Participants
649533|NCT02078492|Secondary|Adverse Effect of Dizziness|the number of study patients who reported having dizziness after administration of medication.|120 minutes|||Participants|||Count of Participants
649534|NCT02078492|Primary|Pain Score at 30 Minutes|Pain score of each group at 30 minutes. The Numeric Rating Pain (NRS) scale was used for the study. The NRS ranges from 0 (no pain) to 10 (very severe pain). A score of 5 is moderate pain. The higher the pain score the higher the pain severity.|30 minutes|||pain score||Standard Deviation|Mean
649535|NCT02078193|Other Pre-specified|Number of Participants With Chronic Kidney Rejection|Incidence of chronic kidney rejection|One year|||participants|||Number
649536|NCT02078193|Secondary|Safety|Incidence of infections|one year|Number of participants with infections||Participant|||Number
649537|NCT02078193|Primary|Change of Donor Specific Antibodies (DSA)|DSA levels will be measured using microbeads coated with Class I or Class II human leukocyte antigens (HLA) and read using a Luminex flow cytometer. Participants will be converted from their current Mycophenolate Mofetil (MMF) to once a month infusions of Belatacept.|one year|||percent change in DSAs||Standard Deviation|Mean
649538|NCT02078180|Secondary|Comparision of the Buproprion Maximum Concentration (Cmax) by Type of Formulation and Dosage|Each formulation of buproprion has a different rate of release. Some release the drug immediately while others release the drug slowly. We will compare the exposure of buproprion by formulation and dose by looking at the maximum concentration. The maximum concentration depends on the rate of drug release and so looking at this value can help us compare differences between formulation.|4 days|||nanogram/milliliter||Standard Error|Mean
649539|NCT02078180|Primary|Comparision of the Buproprion Area Under the Concentration Time Curve (AUC) From Time 0 to 96 Hours by Type of Formulation and Dosage|Each formulation of buproprion has a different rate of release. Some release the drug immediately while others release the drug slowly. We will compare the exposure of buproprion by formulation and dose by looking at the area under the concentration time curve. The area under the concentration time curve is a mathematical way of looking at drug exposure in the body. The reported values are AUC (0-96 hours).|4 days|||h*nanogram/milliliter||Standard Deviation|Mean
649540|NCT02077374|Secondary|Levels of flCK18/M65|Difference in the change in full-length cytokeratin 18 (flCK18/M65) in units per liter (U/L) from Baseline to Day 28/ET between IDN-6556 and placebo|Day 28/ET|The full analysis set (FAS) included all subjects who were randomized and received at least one dose of study drug. For the FAS, subjects were assigned to the treatment group based on the randomization schedule, regardless of the treatment they actually received. All efficacy analyses were conducted on the FAS.||U/L||Full Range|Median
649541|NCT02077374|Secondary|Levels of Caspase 3/7 RLU|Difference in the change of caspase 3/7 (Relative Light Units) from baseline to Day 28/ET between IDN-6556 and Placebo|Day 28/ET|The full analysis set (FAS) included all subjects who were randomized and received at least one dose of study drug. For the FAS, subjects were assigned to the treatment group based on the randomization schedule, regardless of the treatment they actually received. All efficacy analyses were conducted on the FAS.||RLU||Full Range|Median
649620|NCT02075021|Primary|Maximum Tolerated Dose (Phase I)|Dose limiting toxicity will be accessed based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0|4 weeks|Results were not analyzed due to lack of sufficient data. PI left the institution.|||||
653968|NCT01972776|Primary|Change From Baseline in Lung Clearance Index (LCI) (Part 2)||Baseline, 8 weeks|Part 2 was terminated early. Therefore, primary and secondary outcomes for part 2 were not assessed.|||||
649542|NCT02077374|Secondary|Levels of cCK18/M30|Difference in the change in Caspase-cleaved cytokeratin serum levels (cCK18/M30) in units per liter (U/L) from baseline to Day 28/ET between IDN-6556 and placebo|Day 28/ET|The full analysis set (FAS) included all subjects who were randomized and received at least one dose of study drug. For the FAS, subjects were assigned to the treatment group based on the randomization schedule, regardless of the treatment they actually received. All efficacy analyses were conducted on the FAS.||U/L||Full Range|Median
649543|NCT02077374|Secondary|Change in Aspartate Aminotransferase (AST)|Difference in the change in aspartate aminotransferase (AST) from Baseline to Day 28/ET in units per liter (U/L) between IDN-6556 and placebo.|Day 28/ET|The full analysis set (FAS) included all subjects who were randomized and received at least one dose of study drug. For the FAS, subjects were assigned to the treatment group based on the randomization schedule, regardless of the treatment they actually received. All efficacy analyses were conducted on the FAS.||U/L||Full Range|Median
649544|NCT02077374|Primary|Relative Percent Change in Alanine Aminotransferase (ALT)|Back transformation from log-transformed analysis results to original scale in alanine aminotransferase (ALT) from Baseline to Day 28/ET between IDN-6556 vs Placebo|Baseline to Day 28/ET|The full analysis set (FAS) included all subjects who were randomized and received at least one dose of study drug. For the FAS, subjects were assigned to the treatment group based on the randomization schedule, regardless of the treatment they actually received. All efficacy analyses were conducted on the FAS.||Relative percent change||Standard Deviation|Mean
649545|NCT02077374|Primary|Change in Alanine Aminotransferase (ALT)|Mean change in alanine aminotransferase (ALT) from Baseline to Day 28/ET between IDN-6556 vs Placebo|Day 28/ET|The full analysis set (FAS) included all subjects who were randomized and received at least one dose of study drug. For the FAS, subjects were assigned to the treatment group based on the randomization schedule, regardless of the treatment they actually received. All efficacy analyses were conducted on the FAS.||U/L||Standard Deviation|Mean
649546|NCT02076919|Secondary|Change From Mean Arterial Blood Pressure at Each Post Dose Timepoint, Part 2|Mean arterial blood pressure (average pressure in the arteries during one cardiac cycle) was measured using an automated validated device, with an appropriately sized cuff, and assessed in the sitting position after the subject had rested for at least 3 minutes, and again (when required) after 3 minutes in the standing position.|Day 1 and 7: 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose|This analysis population includes all enrolled subjects in Part 2.||mmHg||Standard Error|Least Squares Mean
649547|NCT02076919|Secondary|Change From Baseline in Systolic Blood Pressure at Each Post Dose Timepoint, Part 2|Systolic blood pressure (pressure when the heart is contracting) was measured using an automated validated device, with an appropriately sized cuff, and assessed in the sitting position after the subject had rested for at least 3 minutes, and again (when required) after 3 minutes in the standing position.|Day 1 and 7: 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose|This analysis population includes all enrolled subjects in Part 2.||mmHg||Standard Error|Least Squares Mean
649548|NCT02076919|Secondary|Change From Baseline in Diastolic Blood Pressure at Each Post Dose Timepoint, Part 2|Diastolic blood pressure (pressure in the arteries when the heart rests between beats) was measured using an automated validated device, with an appropriately sized cuff, and assessed in the sitting position after the subject had rested for at least 3 minutes, and again (when required) after 3 minutes in the standing position.|Day 1 and 7: 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose|This analysis population includes all enrolled subjects in Part 2.||mmHg||Standard Error|Least Squares Mean
649549|NCT02076919|Secondary|Change From Baseline in Mean Arterial Blood Pressure at Each Post Dose Timepoint, Part 1|Mean arterial blood pressure (average pressure in the arteries during one cardiac cycle) was measured using an automated validated device, with an appropriately sized cuff, and assessed in the sitting position after the subject had rested for at least 3 minutes, and again (when required) after 3 minutes in the standing position.|Day 1: 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose|This analysis population includes all enrolled subjects in Part 1.||mmHg||Standard Error|Least Squares Mean
649550|NCT02076919|Secondary|Change From Baseline in Systolic Blood Pressure at Each Post Dose Timepoint, Part 1|Systolic blood pressure (pressure when the heart is contracting) was measured using an automated validated device, with an appropriately sized cuff, and assessed in the sitting position after the subject had rested for at least 3 minutes, and again (when required) after 3 minutes in the standing position.|Day 1: 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose|This analysis population includes all enrolled subjects in Part 1.||mmHg||Standard Error|Least Squares Mean
649551|NCT02076919|Primary|Number of Subjects Experiencing a Non-serious Adverse Event, Part 2|An adverse event (AE) was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment.|From time of consent until 30 days after stopping the trial/study drug|This analysis population includes all enrolled subjects in Part 2.||participants|||Number
649552|NCT02076919|Primary|Number of Subjects Experiencing a Non-serious Adverse Event, Part I|An adverse event (AE) was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment.|From time of consent until 30 days after stopping the trial/study drug|This analysis population includes all enrolled subjects in Part 1.||participants|||Number
649553|NCT02076919|Secondary|Change From Baseline in Diastolic Blood Pressure at Each Post Dose Timepoint, Part 1|Diastolic blood pressure (pressure in the arteries when the heart rests between beats) was measured using an automated validated device, with an appropriately sized cuff, and assessed in the sitting position after the subject had rested for at least 3 minutes, and again (when required) after 3 minutes in the standing position.|Day 1: 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose|This analysis population includes all enrolled subjects in Part 1.||mmHg||Standard Error|Least Squares Mean
649621|NCT02075008|Primary|Numbers of Participants With Non-serious Adverse Events (AEs), Serious AEs and Deaths as a Measure of Safety and Tolerability|Safety was monitored throughout the study.|52 weeks|The safety set, which included all participants, was analyzed.||Participants|||Count of Participants
649554|NCT02076919|Secondary|The Terminal Elimination Half-life [Time] (T1/2), Part 2|Plasma concentrations were quantitated using a high performance liquid chromatography/tandem mass spectometry method. Timepoints of assessment for Arms 1-4 were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose; and Day 15: 0h. Timepoints of assessment for LHA Highest BID were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h and 12h post-dose; and Day 15: 0h. Timepoints of assessment for LHA510 Highest TID were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 0h (pre-2nd dose), 0.5h, 2h, 0h (pre-3rd dose), 0.25h, 0.5h, 1h, 2h, 4h, 12h post-dose; and Day 15: 0h.|Up to Day 15|This analysis population includes all enrolled subjects in Part 2.||hour||Standard Deviation|Mean
649555|NCT02076919|Secondary|The Area Under the Plasma (or Serum or Blood) Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [Mass x Time/Volume] (AUClast), Part 2|Plasma concentrations were quantitated using a high performance liquid chromatography/tandem mass spectometry method. Timepoints of assessment for Arms 1-4 were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose; and Day 15: 0h. Timepoints of assessment for LHA Highest BID were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h and 12h post-dose; and Day 15: 0h. Timepoints of assessment for LHA510 Highest TID were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 0h (pre-2nd dose), 0.5h, 2h, 0h (pre-3rd dose), 0.25h, 0.5h, 1h, 2h, 4h, 12h post-dose; and Day 15: 0h.|Up to Day 15|This analysis population includes all enrolled subjects in Part 2.||ng*h/mL||Standard Deviation|Mean
649556|NCT02076919|Secondary|The Time to Reach the Maximum Concentration After Drug Administration [Time] (Tmax), Part 2|Plasma concentrations were quantitated using a high performance liquid chromatography/tandem mass spectometry method. Timepoints of assessment for Arms 1-4 were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose; and Day 15: 0h. Timepoints of assessment for LHA Highest BID were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h and 12h post-dose; and Day 15: 0h. Timepoints of assessment for LHA510 Highest TID were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 0h (pre-2nd dose), 0.5h, 2h, 0h (pre-3rd dose), 0.25h, 0.5h, 1h, 2h, 4h, 12h post-dose; and Day 15: 0h.|Up to Day 15|This analysis population includes all enrolled subjects in Part 2.||hour||Standard Deviation|Mean
649557|NCT02076919|Secondary|The Observed Maximum Plasma (or Serum or Blood) Concentration Following Drug Administration [Mass / Volume] (Cmax), Part 2|Plasma concentrations were quantitated using a high performance liquid chromatography/tandem mass spectometry method.Timepoints of assessment for Arms 1-4 were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose; and Day 15: 0h. Timepoints of assessment for LHA Highest BID were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h and 12h post-dose; and Day 15: 0h. Timepoints of assessment for LHA510 Highest TID were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 0h (pre-2nd dose), 0.5h, 2h, 0h (pre-3rd dose), 0.25h, 0.5h, 1h, 2h, 4h, 12h post-dose; and Day 15: 0h.|Up to Day 15|This analysis population includes all enrolled subjects in Part 2.||ng/mL||Standard Deviation|Mean
649558|NCT02076919|Primary|Number of Subjects With a Serious Adverse Event That, in the Opinion of the Investigator, is Related to the Study Drug, Part 2|A serious adverse event (SAE) was defined as any event which is fatal or life-threatening, which requires or prolongs hospitalization, which is significantly or permanently disabling or incapacitating, which constitutes a congenital anomaly or a birth defect, or which is medically significant, may jeopardize the subject and may require medical or surgical intervention to prevent one of the outcomes listed above.|From time of consent until 30 days after stopping the trial/study drug|This analysis population includes all enrolled subjects in Part 2.||participants|||Number
649559|NCT02076919|Primary|Number of Subjects With a Serious Adverse Event That, in the Opinion of the Investigator, is Related to the Study Drug, Part 1|A serious adverse event (SAE) was defined as any event which is fatal or life-threatening, which requires or prolongs hospitalization, which is significantly or permanently disabling or incapacitating, which constitutes a congenital anomaly or a birth defect, or which is medically significant, may jeopardize the subject and may require medical or surgical intervention to prevent one of the outcomes listed above.|From time of consent until 30 days after stopping the trial/study drug|This analysis population includes all enrolled subjects in Part 1.||participants|||Number
649560|NCT02076334|Secondary|Creatine Kinase||baseline, 24 hrs and 48 hrs post|||u/L||Standard Error|Mean
649561|NCT02076334|Primary|Maximal Voluntary Contraction (MVC)||up to 72 hours|||Newton-meters||Standard Deviation|Mean
649562|NCT02076009|Secondary|Duration of Response (DOR)|DOR was defined for participants with confirmed response (PR or better) as time between first documentation of response and disease progression/death due to PD, whichever occurs first. PD was defined as meeting any one of following criteria: Increase of >=25% in level of serum M-protein from lowest response value and absolute increase must be >=0.5g/dL; Increase of >=25% in 24-hour urinary light chain excretion (urine M-protein) from lowest response value and absolute increase must be >=200mg/24hours; Only in participants without measurable serum and urine M-protein levels: increase of >=25% in difference between involved and uninvolved FLC levels from lowest response value and absolute increase must be >10mg/dL; Definite increase in size of existing bone lesions/soft tissue plasmacytomas; Definite development of new bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5mg/dL) that can be attributed solely to PC proliferative disorder.|From randomization to the date of first documented evidence of PD until 3 years|Response-evaluable set included participants who have a confirmed diagnosis of multiple myeloma and measurable disease and must have received at least 1 administration of study treatment and have at least 1 post baseline disease assessment. Here 'N' signifies number of participants who had PR or better response.||months||95% Confidence Interval|Median
649563|NCT02076009|Secondary|Time to Response|Time to response was defined as the time between the date of randomization and the first efficacy evaluation that the participant met all criteria for partial response (PR) or better.|From randomization up to first documented CR or PR until 3 years|Response-evaluable set is defined as participants who have a confirmed diagnosis of multiple myeloma and measurable disease at baseline or screening visit. In addition, participants must have received at least 1 administration of study treatment and have at least 1 post baseline disease assessment.||months||95% Confidence Interval|Median
649564|NCT02076009|Secondary|Overall Survival (OS)|Overall survival was measured from the date of randomization to the date of the participant's death.|Up to approximately 5 years (anticipated) after the last participant is randomized|ITT analysis set included all participants who were randomly assigned to the DRd or Rd group.||months||95% Confidence Interval|Median
649565|NCT02076009|Secondary|Overall Response Rate|Overall response rate was defined as the percentage of participants who achieved a partial response (PR) or better according to the International Myeloma Working Group (IMWG) criteria, during or after study treatment. IMWG criteria for PR: >=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to <200 mg/24 hours, if the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria, in addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required.|From randomization to disease progression (approximately up to 3 years)|Response-evaluable set included participants who have a confirmed diagnosis of multiple myeloma and measurable disease and must have received at least 1 administration of study treatment and have at least 1 post baseline disease assessment.||percentage of participants|||Number
649566|NCT02076009|Secondary|Percentage of Participants With Negative Minimal Residual Disease (MRD)|Minimal residual disease was assessed for all participants who achieved a complete response (CR) or stringent complete response (sCR). The MRD negativity rate was defined as the percentage of participants who had negative MRD assessment at any time point after the first dose of study drugs by evaluation of bone marrow aspirates or whole blood at 10^- 4 threshold.|From randomization to the date of first documented evidence of PD until 3 years|ITT analysis set included all participants who were randomly assigned to the DRd or Rd group.||percentage of participants|||Number
649567|NCT02076009|Secondary|Percentage of Participants Who Achieved Very Good Partial Response (VGPR) or Better|VGPR or better is defined as the percentage of participants who achieved VGPR, complete response (CR) and stringent complete response (sCR) according to the International Myeloma Working Group criteria (IMWG). IMWG criteria for VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis, or >=90% reduction in serum M-protein plus urine M-protein <100 mg/24 hours, if the serum and urine M-protein are not measurable, a decrease of >90% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria. In addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required; CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and <5% PCs in bone marrow; sCR: CR and normal FLC ratio, absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4 color flow cytometry.|From randomization to disease progression (approximately up to 3 years)|Response-evaluable set included participants who have a confirmed diagnosis of multiple myeloma and measurable disease and must have received at least 1 administration of study treatment and have at least 1 post baseline disease assessment.||percentage of participants||95% Confidence Interval|Number
649568|NCT02076009|Secondary|Time to Disease Progression (TTP)|TTP was defined as time from date of randomization to date of first documented evidence of progressive disease (PD). PD was defined as meeting any one of following criteria: Increase of >=25% in level of serum M-protein from lowest response value and absolute increase must be >=0.5 g/dL; Increase of >=25% in 24-hour urinary light chain excretion (urine M-protein) from lowest response value and absolute increase must be >=200 mg/24hours; Only in participants without measurable serum and urine M-protein levels: increase of >=25% in difference between involved and uninvolved free light chain (FLC) levels from lowest response value and absolute increase must be >10 milligram per deciliter (mg/dL); Definite increase in size of existing bone lesions or soft tissue plasmacytomas; Definite development of new bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to Plasma Cell (PC) proliferative disorder.|From randomization to disease progression until 3 years|ITT analysis set included all participants who were randomly assigned to the DRd or Rd group.||months||95% Confidence Interval|Median
649569|NCT02076009|Primary|Progression-free Survival (PFS)|PFS was defined as duration from date of randomization to either progressive disease (PD)/death, whichever occurred first. PD was defined as meeting any one of following criteria: Increase of greater than equal to (>=)25 percent (%) in level of serum M-protein from lowest response value and absolute increase must be >=0.5 gram per deciliter (g/dL); Increase of >=25% in 24-hour urinary light chain excretion (urine M-protein) from lowest response value and absolute increase must be >=200 mg/24hours; Only in participants without measurable serum and urine M-protein levels: increase of >=25% in difference between involved and uninvolved FLC levels from lowest response value and absolute increase must be >10 mg/dL; Definite increase in size of existing bone lesions or soft tissue plasmacytomas; Definite development of new bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to PC proliferative disorder.|From randomization to either disease progression or death whichever occurs first until 3 years|Intent-to-treat (ITT) analysis set included all participants who were randomly assigned to the daratumumab, lenalidomide, dexamethasone (DRd) or lenalidomide, low-dose dexamethasone (Rd) group.||months||95% Confidence Interval|Median
649570|NCT02075632|Secondary|Number of Days of Use|The number of days subjects used the study medication was summarized for all subjects and by cohort in evaluable subjects.|Day 1-Day 14|A subject was evaluable for summaries of number of days of use, if he or she used the study medication at least once and provided use information at Visit 2. Data for 4 subjects was not available for this analysis.||Days||Standard Deviation|Mean
649571|NCT02075632|Secondary|Number of Times Per Day Participants Used the Product|The number of study medication applications, was summarized for all subjects and by cohort in evaluable subjects.|Day1-Day14|A subject was evaluable for average number of applications per day and maximum number of applications per day if he or she used the study medication at least once and provided use information at Visit 2. Data for four subjects was not available for this analysis.||Applications||Standard Deviation|Mean
649572|NCT02075632|Primary|Number of Participants With Incorrect Duration of Use of the Medication|Incorrect duration of use was defined as the use of study medication for more than 7 consecutive days and/or more than three times in a day. Participants were asked the reasons of doing so and they were allowed to select multiple reasons also, if applicable.|Day1-Day 14|A participant was evaluable for analysis of the rate of incorrect use if he or she used the study medication at least once and provided use information at least 8 days after the enrollment visit.||Participants|||Number
649622|NCT02074995|Secondary|Serum Pharmacokinetics (PK) of BVS857: CL/F; The Apparent Systemic (or Total Body) Clearance From Plasma (or Serum or Blood) Following Extravascular Administration||Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105|Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided|||||
649573|NCT02075515|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From first vaccination up to 30 days post last vaccination (Month 0-Month 3) and from Month 4 to study end (Month 14)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered.||Subjects|||Number
649574|NCT02075515|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During 30 days (Days 0-29) after each vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered.||Subjects|||Number
649575|NCT02075515|Secondary|Number of Subjects With Any Potential Immune-Mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology|From first vaccination up to 30 days post last vaccination (Month 0-Month 3) and from Month 4 until study end (Month 14)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered.||Subjects|||Number
649576|NCT02075515|Secondary|Number of Days With Any Solicited General Symptoms|The number of days with any general symptoms reported during the solicited post-vaccination period.|During the 7 days (Days 0-6) after each vaccine dose|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and with results available for this assessment.||Days||Inter-Quartile Range|Median
649577|NCT02075515|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal (nausea, vomiting, diarrhea and/or abdominal pain), headache, myalgia, shivering and temperature [defined as oral temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature= temperature > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|Within 7 days (Days 0-6) after each vaccine dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered, only on those subjects with the symptom sheets filled in.||Subjects|||Number
649578|NCT02075515|Secondary|Number of Days With Any Solicited Local Symptoms|The number of days with any local symptoms reported during the solicited post-vaccination period.|During the 7 days (Days 0-6) after each vaccine dose|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and with results available for this assessment.||Days||Inter-Quartile Range|Median
649579|NCT02075515|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest, that prevented normal every day activities.|Within 7 days (Days 0-6) after each vaccine dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered, only on those subjects with the symptoms sheet filled in.||Subjects|||Number
649580|NCT02075515|Secondary|Number of Vaccine Responders for Anti-gE Concentrations as Determined by ELISA|"Vaccine response was defined as:
For initially seronegative subjects, antibody concentration at post-vaccination ≥ 4 fold the cut-off for Anti-gE (4x97 mIU/mL); For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration."|At Month 3|The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who had post-vaccination immunogenicity results and who complied with the protocol, including the time schedule for vaccination and blood sample draw.||Subjects|||Number
649581|NCT02075515|Secondary|Anti-gE Humoral Immunogenicity|Anti-gE antibody concentrations, were determined by ELISA, expressed as Geometric Mean Concentrations (GMCs), in milli international units per milliliter (mIU/mL).|At Month 0 and Month 3|The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who had post-vaccination immunogenicity results and who complied with the protocol, including the time schedule for vaccination and blood sample draw.||mIU/mL||95% Confidence Interval|Geometric Mean
649582|NCT02075515|Primary|Number of Subjects With Anti-gE Antibody Concentrations Equal to or Above the Cut-off Value|Anti-gE antibody concentrations, as determined by Enzyme-linked Immunosorbent Assay (ELISA). The cut-off value was ≥ 97 milli international units per milliliter (mIU/mL).|At Month 3|The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all eligible subjects who had post-vaccination immunogenicity results and who complied with the protocol, including the time schedule for vaccination and blood sample draw.||Subjects|||Number
649583|NCT02075463|Secondary|Plasma Concentrations of GSK1278863 and Its Metabolites at the Indicated Time Points|Blood samples were collected for individual plasma GSK1278863and metabolite (GSK2391220, GSK2499166, GSK2531403, GSK2531400, GSK2531399, and GSK2531398) concentrations measurement on Day (D) 1 (pre-dose [PrD]), at Week (W) 4 (6-12, 7-13, 8-14, and 9-15 hour [hr] post-dose [PoD), and at W12 (PrD, 1, 2, and 3 hour PoD). Pharmacokinetic population: All participants from whom a PK sample has been obtained and analyzed.|Day 1, Week 4 and Week 12|Pharmacokinetic population||ng/mL||Standard Deviation|Mean
649584|NCT02075463|Secondary|Final Dose of GSK1278863|For the first 4 weeks, subjects received 12mg QD of GSK1278863 with dose decrease permitted at Week 2. After 4 weeks of treatment with GSK1278863, need for dose adjustment was evaluated at visits 4, 8 and 12, to maintain hemoglobin within the target range. Target range was defined as: Hgb Criteria of 10.0 to 11.5 g/dL. Data has been presented for only those participants who were available at indicated time points.|Up to 16 Weeks|ITT population||mg|||Number
662134|NCT01828476|Secondary|Circulating Tumor Cells Pre-enrollment and During Therapy||5 years|Study was terminated early and insufficient data was collected to assess this outcome measure.|||||
649585|NCT02075463|Secondary|Maximum Observed Change From Baseline in Erythropoietin (EPO)|Blood samples were collected on Day 1 (pre-dose), Week 4 (6-12 hours post-dose, then 1, 2 and 3 hours after first sample), Week 8 (pre-dose), Week 12 (pre-dose and 3 hour post-dose) and Week 16 (pre-dose) for EPO measurement. The maximum observed change from baseline in EPO was reported. Baseline value for EPO is the last pre-dose value on Day 1. Change from baseline is calculated as the maximum observed value minus the baseline value. Participants who were available at the indicated time point were analyzed.|Baseline (Day 1) to Week 16|ITT population||international units(IU)/Liter (L)||Standard Deviation|Mean
649586|NCT02075463|Secondary|Maximum Observed Percent Change From Baseline in Vascular Endothelial Growth Factor (VEGF)|Blood samples were collected on Day 1 (pre-dose), Week 4 (6-12 hours post-dose, then 1, 2 and 3 hours after first sample), Week 8 (pre-dose), Week 12 (pre-dose and 3 hour post-dose) and Week 16 (pre-dose) for VEGF measurement. The maximum observed percent change from Baseline in VEGF in the subjects was reported. Baseline value for VEGF is the last pre-dose value on Day 1. Percent change was calculated as 100 multiplied by exponential (log observed maximum value minus log Baseline value) minus 1. Participants who were available at the indicated time point were analyzed.|Baseline (Day 1) to Week 16|ITT population||Percent change||95% Confidence Interval|Geometric Mean
649587|NCT02075463|Secondary|Change From Baseline in Reticulocyte Number at Week 16|Baseline value for reticulocyte number is the pre-dose value on Day 1. Change from Baseline in reticulocyte number was calculated as the Week 16 value minus the Baseline value. Data has been presented for only those participants who were available at indicated time points.|Baseline (Day 1) and Week 16|ITT population||10^12/L|||Number
649588|NCT02075463|Secondary|Change From Baseline in Red Blood Cell (RBC) at Week 16|Baseline value for RBC (or erythrocytes) is the last pre-dose value on Day 1. Change from Baseline in red blood cells was calculated as the Week 16 value minus the Baseline value. Data has been presented for only those participants who were available at indicated time points|Baseline (Day 1) and Week 16|ITT population||10^12/L|||Number
649589|NCT02075463|Secondary|Change From Baseline in Hematocrit at Week 16|Hematocrit is the ratio of the volume of red blood cells to the total volume of blood. Baseline value for hematocrit is the pre-dose value on Day 1. Change from Baseline in hematocrit was calculated as the Week 16 value minus the Baseline value. Data has been presented for only those participants who were available at indicated time points.|Baseline (Day 1) and Week 16|ITT population||Fraction of 1|||Number
649590|NCT02075463|Secondary|Mean Corpuscular Hemoglobin (MCH) at Week 16|Data has been presented for only those participants who were available at indicated time points.|Week 16|Safety population||pg|||Number
649591|NCT02075463|Secondary|Mean Corpuscular Volume (MCV) at Week 16|Data has been presented for only those participants who were available at indicated time points.|Week 16|Safety population||Femtoliter (fL)|||Number
649592|NCT02075463|Secondary|Reticulocyte Hgb Content (CHr) at Week 16|Data has been presented for only those participants who were available at indicated timepoints|Week 16|Safety population consisted of all participants who received at least one dose of study drug||Picogram (pg)|||Number
649593|NCT02075463|Secondary|Change From Baseline in Total Iron Binding Capacity (TIBC) at Week 16|Total iron-binding capacity is a medical laboratory test that measures the blood's capacity to bind iron with transferrin. Baseline value for total iron binding capacity is the last pre-dose value on Day 1. Change from Baseline in total iron binding capacity was calculated as the Week 16 value minus the Baseline value. Data has been presented for only those participants who were available at indicated time points.|Baseline (Day 1) and Week 16|ITT population||µmol/ L|||Number
649594|NCT02075463|Secondary|Change From Baseline in Total Iron at Week 16|Baseline value for total iron is the last pre-dose value on Day 1. Change from Baseline in total iron was calculated as the Week 16 value minus the Baseline value. Data has been presented for only those participants who were available at indicated time points.|Baseline (Day 1) and Week 16|ITT population||Micromoles (µmol)/L|||Number
649595|NCT02075463|Secondary|Percent Change From Baseline in Transferrin Saturation at Week 16|Transferrin saturation is measured in percentage, it is the ratio of serum iron and total iron-binding capacity, multiplied by 100. Baseline value for transferrin saturation is the pre-dose value on Day 1. Percent change is 100 times [exponential (log Week 16 value minus log Baseline value) -1]. Participants who were available at the indicated time point were analyzed.|Baseline (Day 1) and Week 16|ITT population||Percent change in transferrin||95% Confidence Interval|Geometric Mean
649596|NCT02075463|Secondary|Change From Baseline in Transferrin at Week 16|Baseline value for transferrin is the last pre-dose value on Day 1. Change from Baseline in transferrin was calculated as the Week 16 value minus the Baseline value. Participants who were available at the indicated time point were analyzed.|Baseline (Day 1) and Week 16|ITT population||Percent change||Standard Deviation|Mean
649597|NCT02075463|Secondary|Change From Baseline in Ferritin at Week 16|Baseline value for ferritin is the last pre-dose value on Day 1. Change from Baseline in ferritin was calculated as the Week 16 value minus the Baseline value. Participants who were available at the indicated time point were analyzed.|Baseline (Day 1) and Week 16|ITT population||Micrograms/Liter||Standard Deviation|Mean
649598|NCT02075463|Secondary|Percent Change From Baseline in Hepcidin at Week 16|Hepcidin is a regulator of iron metabolism. Baseline value for hepcidin is the pre-dose value on Day 1. Percent change was calculated as 100 multiplied by [exponential (log Week 16 value - log Baseline value) minus 1]. Participants who were available at the indicated time point were analyzed.|Baseline (Day 1) and Week 16|ITT population||Percent change in hepcidin||95% Confidence Interval|Geometric Mean
649599|NCT02075463|Secondary|Number of Participants Reaching Pre-defined Hgb Stopping Criteria|The number of participants who reached the Hgb stopping criteria of Hgb concentration <7.5 g/dL from baseline to Week 16 were presented. Participants who were available at the indicated time point were analyzed.|Up to Week 16|ITT population||Participants|||Number
649600|NCT02075463|Secondary|Number of Participants With Hgb in the Target Range at Week 16|The number of participants with Hgb in the target range of 10.0 to 11.5 g/dL at Week 16 were analyzed. Participants who were available at the indicated time point were analyzed.|Week 16|ITT population||Participants|||Number
649601|NCT02075463|Secondary|Number of Participants Achieving at Least 1 g/dL Increase in Hgb From Baseline at Week 16|Number of participants achieving at least 1 g/dL increase in Hgb from baseline at Week 16 were presented. Participants who were available at the indicated time point were analyzed.|Baseline and Week 16|ITT population.||Participants|||Number
649602|NCT02075463|Secondary|Percentage of Time (Days) Hgb Levels Within, Below and Above Target Range at the Indicated Time Point|The percentage of time in Hgb levels were in target range (10.0 to 11.5 g/dL) between Weeks 12 and 16 for a participant was calculated by adding the total number of days that Hgb is within target range while on treatment during Weeks 12 to 16 and dividing by the total number of days the participant remained on treatment during Weeks 12 to 16 (using Rosendaal linear interpolation method). Similarly, percentage of time above Hgb target range and percentage of time below Hgb target range were calculated. Participants who were available at the indicated time point were analyzed.|Week 12 to Week 16|ITT population.||Percentage of days||Standard Deviation|Mean
649603|NCT02075463|Secondary|Change From Baseline in Hgb Levels at Week 16|Hgb values measured at Week 16 are presented. Change from baseline was calculated as Week 16 minus baseline value . Participants who were available at the indicated time point were analyzed.|Week 16|ITT population.||g/dL||Standard Deviation|Mean
649604|NCT02075463|Primary|Percentage of Participants Demonstrating an Increase in Hgb of >=1 g/dL (if Baseline Hgb is <9.5 g/dL), or >=0.5 g/dL (if Baseline Hgb is 9.5-<10 g/dL), or Stay Within Target Range and do Not Drop by >0.5 g/dL (if Baseline Hgb is >= 10 g/dL) at Week 16|Percentage of participants with increased Hgb >=1 g/dL (if baseline Hgb is <9.5 g/dL), or >=0.5 g/dL (if baseline Hgb is 9.5-<10 g/dL), or within the target range and not dropped by >0.5 g/dL (if baseline Hgb is >= 10 g/dL) at Week 16 are presented. Participants who were available at the indicated time point were analyzed|Week 16|ITT population: participants who received at least one dose of drug, have a baseline Hgb and at least one corresponding on treatment Hgb assessment.||Percentage of participants||95% Confidence Interval|Number
649605|NCT02075411|Other Pre-specified|Failure of Nerve Block Procedures|We will determine the proportion of failure of the nerve block procedures as assessed by absence of a sensory block in the distribution of the femoral or sciatic nerves. The analysis will be of the numerical rating scale (NRS) scores immediately on arrival (baseline) in the recovery room and then every 6 hours over the first 72 hours post-op in the 2 groups.|72 hours post-operatively|Sample size was too small to conduct outcome analysis|||||
649606|NCT02075411|Secondary|Duration of Analgesia in the Single Injection Nerve Block and the Continuous Peripheral Neural Infusion Group|Determine the duration of analgesia in the 2 groups. Analgesic duration will be the time interval between the end of the operation and the time of first administration of opioid for pain relief|72 hours post-operatively|Sample size was too small to conduct outcome analysis|||||
649607|NCT02075411|Primary|Opioid Pain Medication|total postoperative opioid pain medication used during the first 72 hours after the procedure|72 hours post-operatively|Sample size was too small to conduct outcome analysis|||||
649608|NCT02075125|Secondary|Pre-procedure Platelet Reactivity Index (PRI)|Platelet reactivity was measured using vasodilator-stimulated phosphoprotein (VASP) phosphorylation P2Y12 assay. Platelet reactivity values were presented as platelet reactivity index (PRI).|Baseline|Analysis population was performed on an intention to treat basis, descriptive analysis was performed by presenting the data as median (Inter-Quartile Range).||percentage||Inter-Quartile Range|Median
649609|NCT02075125|Secondary|Number of Participants With Low Platelet Reactivity|Platelet reactivity were measured using VerifyNow (volumetrics accuretic, San Diego, California, USA), and vasodilator-stimulated phosphoprotein (VASP) phosphorylation P2Y12 assay (BioCytex, Marseille, France) with FACSCalibur flow cytometer (BD Biosciences, San Jose, California, USA) using. Measurement time gap +/- 12 hours were allowed. Low platelet reactivity (LPR) is defined as the result of P2Y12 reaction units (PRU) <85 and platelet reactivity index (PRI)<16%. The PRU value for LPR, 18 patients were in prasugrel groups and 19 patients in ticagrelor groups, regarding the PRI value for LPR, 16 patients were in each groups.|48 hours after loading dose of study drug|Analysis population was performed on an intention to treat basis, descriptive analysis was performed by presenting the data as number (proportion), compared with chi-square statistics or Fisher’s exact test, as appropriate.||participants|||Number
649610|NCT02075125|Secondary|Pre-procedure P2Y12 Reaction Units (PRU)|Platelet reactivity was measured using VerifyNow (volumetrics accuretic, San Diego, California, USA). Platelet reactivity values were presented as P2Y12 reaction units (PRU).|Baseline|Analysis population was performed on an intention to treat basis, descriptive analysis was performed by presenting the data as median (Inter-Quartile Range).||PRU units||Inter-Quartile Range|Median
649611|NCT02075125|Secondary|Adverse Drug Reaction|Any adverse reaction related to study drug until 30 days after percutaneous coronary intervention.|30 days|Analysis population was performed on an intention to treat basis, descriptive analysis was performed by presenting the data as number, compared with chi-square statistics or Fisher’s exact test, as appropriate.||participants|||Number
649612|NCT02075125|Secondary|Bleeding Event|Any event related to bleeding including access site bleeding and peri-procedural bleeding based on Bleeding Academic Research Consortium (BARC) criteria.|30 days|Analysis population was performed on an intention to treat basis, descriptive analysis was performed by presenting the data as number (proportion), compared with chi-square statistics or Fisher’s exact test, as appropriate.||participants|||Number
649613|NCT02075125|Secondary|Major Adverse Cardiac and Cerebrovascular Events|Any major adverse cardiac and cerebrovascular event including (death, myocardial infarction, or revascularization and stroke) until day 30.|30 days|Analysis population was performed on an intention to treat basis, descriptive analysis was performed by presenting the data as number (proportion), compared with chi-square statistics or Fisher’s exact test, as appropriate.||participants|||Number
649614|NCT02075125|Primary|Number of Participants With High Platelet Reactivity|Platelet reactivity were measured by VerifyNow (volumetrics accuretic，San Diego, California, USA), and vasodilator-stimulated phosphoprotein (VASP) phosphorylation P2Y12 assay (BioCytex, Marseille, France) with FACSCalibur flow cytometer (BD Biosciences, San Jose, California, USA) using. Measurement time gap +/- 12 hours were allowed. High platelet reactivity (HPR) is defined as the result of P2Y12 reaction units (PRU) >235 and platelet reactivity index (PRI) >50%.|48 hours after loading dose of study drug|Analysis population was performed on an intention to treat basis, descriptive analysis was performed by presenting the data as number (proportion), compared with chi-square statistics or Fisher’s exact test, as appropriate.||participants|||Number
649615|NCT02075073|Secondary|Time to Cmax (Tmax)||57 days|||hour||Standard Deviation|Mean
649616|NCT02075073|Primary|Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)||57 days|||µg·h/mL||Standard Deviation|Mean
649617|NCT02075073|Primary|Maximum Serum Concentration (Cmax)||57 days|||µg/mL||Standard Deviation|Mean
649623|NCT02074995|Secondary|Serum Pharmacokinetics (PK) of BVS857: Vz/F; The Apparent Volume of Distribution During the Terminal Elimination Phase Following Extravascular Administration||Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105|Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided|||||
649624|NCT02074995|Secondary|Serum Pharmacokinetics (PK) of BVS857: Vss; The Volume of Distribution at Steady State Following Intravenous Administration||Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105|Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided|||||
649625|NCT02074995|Secondary|Serum Pharmacokinetics (PK) of BVS857: Vz; The Volume of Distribution During the Terminal Elimination Phase Following Intravenous Administration||Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105|Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided|||||
649626|NCT02074995|Secondary|Serum Pharmacokinetics (PK) of BVS857: CL; The Systemic (or Total Body) Clearance From Plasma (or Serum or Blood) Following Intravenous Administration||Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105|Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided|||||
649627|NCT02074995|Secondary|Serum Pharmacokinetics (PK) of BVS857: T1/2; The Terminal Elimination Half-life||Groups 1: Day 1through to Day 56: Groups 2,3&4:ay D1 through to Day 105|Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided|||||
649628|NCT02074995|Secondary|Serum Pharmacokinetics (PK) of BVS857: AUCinf; The Area Under the Plasma (or Serum or Blood) Concentration-time Curve From Time Zero to Infinity||Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105|Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided|||||
649629|NCT02074995|Secondary|Serum Pharmacokinetics (PK) of BVS857: AUClast; The Area Under the Plasma (or Serum or Blood) Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration||Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105|Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided|||||
649630|NCT02074995|Secondary|Serum Pharmacokinetics (PK) of BVS857: Tmax; The Time to Reach the Maximum Concentration After Drug Administration||Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105|Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided|||||
649631|NCT02074995|Secondary|Serum Pharmacokinetics (PK) of BVS857: Cmax; The Observed Maximum Plasma (or Serum or Blood) Concentration Following Drug Administration||Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105|Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided|||||
649632|NCT02074995|Primary|Efficacy Measure by Change in Lean Body Mass (LBM)|Total LBM is measured by dual energy X-ray absorptiometry (DXA) scan.|Groups 2,3&4: Baseline, Day 35, Day 85 and Day 106|Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided|||||
649633|NCT02074995|Primary|Number of Patients With Adverse Events as a Measure of Safety and Tolerability|Number of patients with adverse events as a measure of safety and tolerability|Over 1 year|||Participants|||Number
649634|NCT02074982|Secondary|Percentage of Participants With Moderate to Severe Plaque Psoriasis Who Achieved Psoriasis Area and Severity Index (PASI) 90 at Week 52|"Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).
PASI 90 responders were defined as participants achieving ≥ 90% improvement at Week 52"|Week 52|Full Analysis Set (FAS) included all randomized patient minus 1 patient that was excluded due to missing informed consent prior to initiating study procedures.||percentage of participants|||Number
649635|NCT02074982|Secondary|Speed of Onset Based on the Percentage of Participents Achieving PASI 75 at Week 4|"Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).
Speed of Onset was based on percentage PASI 75 responders and were defined as participants achieving ≥ 75% improvement at Week 4"|Week 4|Full Analysis Set (FAS) included all randomized patient minus 1 patient that was excluded due to missing informed consent prior to initiating study procedures.||percentage of participants|||Number
649636|NCT02074982|Primary|Percentage of Participants With Moderate to Severe Plaque Psoriasis Who Achieved Psoriasis Area and Severity Index (PASI) 90 at Week 16|"Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).
PASI 90 responders were defined as participants achieving ≥ 90% improvement at Week 16"|Week 16|Full Analysis Set (FAS) included all randomized patient minus 1 patient that was excluded due to missing informed consent prior to initiating study procedures.||Percentage of Participants|||Number
649637|NCT02074709|Primary|Postoperative Pain Score on Coughing at 6 hr|Visual Analog Pain Scores (VAS); 0 (no pain) to 10 (worst possible pain)|Participants` pain score was assessed at 6 hr after surgery|||units on a scale||Standard Deviation|Mean
649638|NCT02074553|Secondary|Time to Reach Last Quantifiable Plasma Concentration (Tlast) of Alectinib and RO5468924|Tlast is the time from alectinib administration to reach last quantifiable concentration of alectinib and its major pharmacologically active metabolite RO5468924.|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set||hours||Full Range|Median
649639|NCT02074553|Secondary|Molecular Weight Adjusted M/P Ratio for Cmax|Cmax is the maximum observed plasma concentration of the alectinib and RO5468924 (major pharmacologically active metabolite of alectinib). The molecular weight adjusted M/P ratio (RO5468924/alectinib) for Cmax is presented.|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set||ratio||Standard Deviation|Geometric Mean
649640|NCT02074553|Secondary|Molecular Weight Adjusted M/P Ratio for AUC(0-last)|AUC(0-last) is the area under the plasma concentration versus time curve from time zero to the time of last measured concentration. AUC is a measure of the plasma concentration of the alectinib and RO5468924 (major pharmacologically active metabolite of alectinib) over time. The molecular weight adjusted M/P ratio (RO5468924/alectinib) for AUC(0-last) is presented.|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set||ratio||Standard Deviation|Geometric Mean
649641|NCT02074553|Secondary|Molecular Weight Adjusted Metabolite to Parent (M/P) Ratio for AUC(0-inf)|AUC(0-inf) is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). AUC is a measure of the plasma concentration of the alectinib and RO5468924 (major pharmacologically active metabolite of alectinib) over time. The molecular weight adjusted M/P ratio (RO5468924/alectinib) for AUC(0-inf) is presented.|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set||ratio||Standard Deviation|Geometric Mean
649642|NCT02074553|Secondary|Adjusted r^2 Value (Rsq) for Regression Estimation of Kel for Alectinib and RO5468924||Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set||no units||Standard Deviation|Mean
649643|NCT02074553|Secondary|Percent Extrapolated AUC(0-inf) (AUC%Extrap[0-inf]) for Alectinib and RO5468924|The AUC%extrap(0-inf), that is, area obtained after extrapolation from Tlast to infinity is calculated by using the formula AUC%extrap(0-inf) = 100*(AUC[0-inf] minus AUC[0-last])/AUC(0-inf); where AUC(0-inf) = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time and AUC(0-last) is area under the plasma concentration time-curve from zero (pre-dose) to the time of last measured concentration. The function of this parameter is to provide information about what percentage of the theoretical curve AUC(0-inf) was possible to determine experimentally (AUC0-last).|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set||percent AUC||Standard Deviation|Mean
649644|NCT02074553|Secondary|Apparent Volume of Distribution (Vz/F) of Alectinib|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction of drug absorbed.|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set||liters||Standard Deviation|Mean
649645|NCT02074553|Secondary|Apparent Oral Clearance (CL/F) of Alectinib|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set||liters/hour||Standard Deviation|Mean
649646|NCT02074553|Secondary|Total Molar Concentration of Alectinib and RO5468924 as Derived by AUC(0-last)|AUC(0-last) is the area under the alectinib + RO5468924 (major pharmacologically active metabolite of alectinib) molar plasma concentration versus time curve from time zero to the time of last measured concentration of alectinib + RO5468924. AUC(0-last) is presented in nmol*hour/L.|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set||nmol*hour/L||Standard Deviation|Mean
649647|NCT02074553|Secondary|Total Molar Concentration of Alectinib and RO5468924 as Derived by Cmax|Cmax is the maximum observed molar plasma concentration for alectinib + RO5468924 (major pharmacologically active metabolite of alectinib). Cmax is presented in nanomoles per liter (nmol/L).|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set||nmol/L||Standard Deviation|Mean
649648|NCT02074553|Secondary|Total Molar Concentration of Alectinib and RO5468924 as Derived by AUC(0-inf)|AUC(0-inf) is the area under the alectinib + RO5468924 (major pharmacologically active metabolite of alectinib) molar plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). AUC is a measure of the plasma concentration of the alectinib + RO5468924 over time. AUC(0-inf) is presented in nanomoles times (*) hour per liter (nmol*hour/L).|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set||nmol*hour/L||Standard Deviation|Mean
649649|NCT02074553|Secondary|Elimination Rate Constant (Kel) of Alectinib and RO5468924|First-order terminal elimination rate constant (Kel) was calculated as the negative slope of the linear regression of the terminal phase in plasma alectinib and RO5468924 concentration versus time profile using appropriate time points. RO5468924 is the major pharmacologically active metabolite of alectinib.|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set||1/hour||Standard Deviation|Mean
649650|NCT02074553|Secondary|Plasma Terminal Half-Life (t1/2) of Alectinib and RO5468924|Plasma terminal half-life is the time measured during drug elimination phase for the plasma drug concentration to decrease by one half. RO5468924 is the major pharmacologically active metabolite of alectinib.|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set||hours||Standard Deviation|Mean
649651|NCT02074553|Secondary|AUC(0-last) of RO5468924|AUC(0-last) is the area under the RO5468924 plasma concentration versus time curve from time zero to the time of last measured concentration of RO5468924. RO5468924 is the major pharmacologically active metabolite of alectinib. AUC is a measure of the plasma concentration of a drug over time. AUC(0-last) is presented in ng*hour/mL.|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set||ng*hour/mL||Standard Deviation|Mean
649801|NCT02071082|Secondary|Change From Baseline in FibroTest® Score at Week 48|The FibroTest® score is used to assess liver fibrosis. Scores range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis.|Baseline; Week 48|Participants in the Full Analysis Set with available data were analyzed.||units on a scale||Inter-Quartile Range|Median
649652|NCT02074553|Secondary|AUC(0-inf) of RO5468924|AUC(0-inf) is the area under the RO5468924 plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). RO5468924 is the major pharmacologically active metabolite of alectinib. AUC is a measure of the plasma concentration of a drug over time. AUC(0-inf) is presented in ng*hour/mL.|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set||ng*hour/mL||Standard Deviation|Mean
649653|NCT02074553|Secondary|Tmax of RO5468924|Tmax is the time from alectinib administration to reach Cmax for RO5468924 (the major pharmacologically active metabolite of alectinib).|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set||hours||Full Range|Median
649654|NCT02074553|Secondary|Cmax of RO5468924|Cmax is the maximum observed plasma RO5468924 concentration, presented in ng/mL. RO5468924 is the major pharmacologically active metabolite of alectinib.|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set||ng/mL||Standard Deviation|Mean
649655|NCT02074553|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Alectinib|Tmax is the time from alectinib administration to reach Cmax for alectinib.|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set||hours||Full Range|Median
649656|NCT02074553|Primary|Maximum Observed Plasma Concentration (Cmax) of Alectinib|Cmax is the maximum observed plasma alectinib concentration, presented in nanogram per milliliter (ng/mL).|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set||ng/mL||Standard Deviation|Mean
649657|NCT02074553|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC[0-last]) of Alectinib|AUC(0-last) is the area under the alectinib plasma concentration versus time curve from time zero to the time of last measured concentration of alectinib. AUC is a measure of the plasma concentration of a drug over time. AUC(0-last) is presented in ng*hour/mL.|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set||ng*hour/mL||Standard Deviation|Mean
649658|NCT02074553|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to Extrapolated Infinite Time (AUC[0-inf]) of Alectinib|AUC(0-inf) is the area under the alectinib plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). AUC is a measure of the plasma concentration of a drug over time. AUC(0-inf) is presented in nanogram times (*) hour per milliliter (ng*hour/mL).|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|The Pharmacokinetic (PK) analysis set included all participants who received the reference formulation 50% SLS alectinib (Treatment A) and at least 1 test formulation (Treatments B, C, or D) and provided adequate PK assessments.||ng*hour/mL||Standard Deviation|Mean
649659|NCT02074514|Secondary|Percentage of Participants With Virologic Failure and Viral Relapse|"Virologic failure was defined as:
On-treatment virologic failure:
Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)
Virologic relapse:
Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 24|Full Analysis Set||percentage of participants|||Number
649660|NCT02074514|Secondary|Percentage of Participants With Sustained Virologic Response (SVR) at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set||percentage of participants||95% Confidence Interval|Number
649661|NCT02074514|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 24 weeks|Safety Analysis Set||percentage of participants|||Number
649662|NCT02074514|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) 12 weeks following the last dose of study drug.|Posttreatment Week 12|Full Analysis Set (FAS): participants with genotype 1 or 3 HCV infection who were randomized into the study and received at least 1 dose of study drug.||percentage of participants||95% Confidence Interval|Number
649663|NCT02074384|Primary|Portion of Study Participants Reporting Greater Utility From AGP vs. Traditional Glucose Data Reports|Patients will use either SMBG or CGM for a two week period following their screening visit. At the end of the two week period they will return to the study site to download their device and have an AGP report printed. They will then complete a preference and utility survey.|At the end of the two week SMBG or CGM period|||participants|||Number
649664|NCT02074358|Secondary|Mean Change From Baseline Temperature on Day 4 and Day 7|Temperature was recorded at screening, Day -1 of Period 1, and Days 4 and 7 of each period and was measured in degrees centigrade (C). Baseline was last non-missing result with a collection date-time less than the date-time of the first active dose.|Screening, Day -1 first treatment period, Days 4 and 7 post treatment|Those participants who received any study medication and had temperature data at baseline and post baseline were analyzed.||C||Standard Deviation|Mean
649665|NCT02074358|Secondary|Mean Change From Baseline in Respiration Rate on Day 4 and Day 7|Respiration Rate was recorded at screening, Day -1 of Period 1, and Days 4 and 7 of each period. Respiration Rate was measured after the participant had been seated quietly for at least 5 minutes and was measured in respirations (breaths) per minute. Baseline was last non-missing result with a collection date-time less than the date-time of the first active dose.|Screening, Day -1 first treatment period, Days 4 and 7 post treatment|Those participants who received any study medication and had respiration rate data at baseline and post baseline were analyzed.||breaths per minute||Standard Deviation|Mean
649666|NCT02074358|Secondary|Mean Change From Baseline in Heart Rate on Day 4 and Day 7|Heart Rate was recorded at screening, Day -1 of Period 1, and Days 4 and 7 of each period. Heart Rate was measured after the participant had been seated quietly for at least 5 minutes and was measured in beats per minute (bpm). Baseline was last non-missing result with a collection date-time less than the date-time of the first active dose.|Screening, Day -1 first treatment period, Days 4 and 7 post treatment|Those participants who received any study medication and had heart rate data at baseline and post baseline were analyzed.||bpm||Standard Deviation|Mean
649667|NCT02074358|Secondary|Mean Change From Baseline in Diastolic and Systolic Blood Pressure on Day 4 and Day 7|Blood pressures were recorded at screening, Day -1 of Period 1, and Days 4 and 7 of each period. Blood pressure was measured after the participant had been seated quietly for at least 5 minutes and was measured in millimeters of mercury (mmHg). Baseline was last non-missing result with a collection date-time less than the date-time of the first active dose.|Screening, Day -1 first treatment period, Days 4 and 7 post treatment|Those participants who received any study medication and had blood pressure data at baseline and post baseline were analyzed.||mmHg||Standard Deviation|Mean
649668|NCT02074358|Secondary|Number of Participants With Out of Range Electrocardiogram (ECG) Intervals and Number of Participants With a Change From Baseline of Greater Than 30 Milliseconds in QT and QTcF|Single 12-lead ECGs were obtained at screening, Day -1 of Period 1, and Days 4 and 7 of each treatment period after the participant had been supine for at least 5 minutes. Pulse Rate (PR), Complex of Q, R, S waves (QRS), and contraction of ventricle between the beginning of the Q wave and end of the T wave (QT) were measured in milliseconds (msec). QT was corrected by the Fridericia method (QTcF) and measured in msec. Baseline was Day -1 of first treatment period. Crossover study: same participant with out of range ECG intervals could be reported in multiple arms.|Day -1 first treatment period, Days 4 and 7 each treatment period|Those participants who received any study medication and had available ECG data at baseline and Days 4 and 7 in each treatment period were analyzed.||participants|||Number
649669|NCT02074358|Secondary|Number of Participants With Marked Abnormalities (MA) in Laboratory Tests - Treated Population|Blood, urine samples obtained at screening, Days -1, 4, and 7 of each treatment period, and study discharge (Day 11 of Treatment Period 3). MA: Leukocyte White Blood Cells (WBC) *10^3 cells per microliter (c/µL); High (H): > 1.2*upper limits normal (ULN) if lower limits normal (LLN) <= pre-therapy (PreRx) <= ULN; > 1.2*ULN if PreRx = Missing; > 1.5*PreRx if PreRx > ULN; > ULN if PreRx < LLN. Alanine Aminotransferase (ALT) units per liter (U/L); H: > 1.25*PreRx if PreRx > ULN; > 1.25*ULN if PreRx <= ULN; > 1.25*ULN if PreRx = Missing. Total and Direct Bilirubin in milligrams/deciliter (mg/dL) H: > 1.1*ULN if PreRx <= ULN;> 1.1*ULN if PreRx = Missing; > 1.25*PreRx if PreRx > ULN. Blood in Urine H: >= 2*PreRx if PreRx >= 1; >= 2 if PreRx < 1; >= 2 if PreRx = Missing. Urine Red Blood Cells (RBC) and Urine WBC/ high powered field (hpf) H: >= 2 if PreRx = Missing; >= 2 if PreRx < 2; >= 4 if PreRx >= 2. Crossover study: same participant with MA could be reported in multiple arms.|Day 1 (first dose) to Day of Study Discharge (Day 11 of Treatment Period 3)|All participants who received any study medication and had available laboratory test data were analyzed. n=number of participants evaluated.||participants|||Number
649670|NCT02074358|Secondary|Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs), and Discontinuation Due to AEs - Treatment Population|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. Medical Dictionary for Regulatory Activities (MedDRA) version 17.0 was used.|Day 1 to 30 days Post Last Dose|Treated population: All participants who received at least one dose of study medication were analyzed.||participants|||Number
649671|NCT02074358|Secondary|Mean Terminal Elimination Half-Life (T-HALF) of Apixaban on Day 4|Plasma samples for PK analysis were obtained on Day 4 at 0 hour (pre-dose), 0.5, 1, 2, and 3 hours post apixaban dose, and at 0.5, 1, 2, 4, 6, 9 hours post infusion (PCC or Placebo), and at 21, 45, and 69 hours post infusion (Days 5, 6, and 7) in each treatment period. PK parameters were derived from plasma concentration versus time. Concentration of apixaban was determined using a validated LC/MS/MS assay within the period of known analyte stability. T-HALF was measured in hours|Day 4|Those participants who received any study medication and had adequate PK profiles were included; 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.||hours||Standard Deviation|Mean
649672|NCT02074358|Secondary|Geometric Mean Trough Observed Plasma Concentration at the End of One Dosing Interval (12h) [Cmin] of Apixaban on Day 4|Plasma samples for PK analysis were obtained on Day 4 at 0 hour (pre-dose), 0.5, 1, 2, and 3 hours post apixaban dose, and at 0.5, 1, 2, 4, 6, 9 hours post infusion (PCC or Placebo), and at 21, 45, and 69 hours post infusion (Days 5, 6, and 7) in each treatment period. PK parameters were derived from plasma concentration versus time. Concentration of apixaban was determined using a validated LC/MS/MS assay within the period of known analyte stability. Cmin was measured in nanograms per milliliter (ng/mL).|Day 4|Those participants who received any study medication and had adequate PK profiles were included; 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
649673|NCT02074358|Secondary|Adjusted Geometric Mean AUC (0-24) for Apixaban on Day 4|Plasma samples for PK analysis were obtained on Day 4 at 0 hour (pre-dose), 0.5, 1, 2, and 3 hours post apixaban dose, and at 0.5, 1, 2, 4, 6, 9 hours post infusion (PCC or Placebo), and at 21, 45, and 69 hours post infusion (Days 5, 6, and 7) in each treatment period. PK parameters were derived from plasma concentration versus time. Concentration of apixaban was determined using a validated LC/MS/MS assay within the period of known analyte stability.|Day 4|Those participants who received any study medication and had adequate PK profiles were included; 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.||ng*h/mL||90% Confidence Interval|Geometric Mean
649674|NCT02074358|Secondary|Geometric Mean Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours After Dose Administration [AUC(0-24)] of Apixaban on Day 4|Plasma samples for PK analysis were obtained on Day 4 at 0 hour (pre-dose), 0.5, 1, 2, and 3 hours post apixaban dose, and at 0.5, 1, 2, 4, 6, 9 hours post infusion (PCC or Placebo), and at 21, 45, and 69 hours post infusion (Days 5, 6, and 7) in each treatment period. PK parameters were derived from plasma concentration versus time. Concentration of apixaban was determined using a validated LC/MS/MS assay within the period of known analyte stability. AUC(0-24) was measured in ng*h/mL.|Day 4|Those participants who received any study medication and had adequate PK profiles were included; 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
649820|NCT02070640|Secondary|Incidence of Anatomic Identification With NIRF-C|Incidence of anatomic identification with NIRF-C and intraoperative cholangiography.|Intraoperative|||percentage of biliary anatomy observatio|||Number
649675|NCT02074358|Secondary|Adjusted Geometric Mean AUC (0-12) of Apixaban on Day 4|Plasma samples for PK analysis were obtained on Day 4 at 0 hour (pre-dose), 0.5, 1, 2, and 3 hours post apixaban dose, and at 0.5, 1, 2, 4, 6, 9 hours post infusion (PCC or Placebo), and at 21, 45, and 69 hours post infusion (Days 5, 6, and 7) in each treatment period. PK parameters were derived from plasma concentration versus time. Concentration of apixaban was determined using a validated LC/MS/MS assay within the period of known analyte stability.|Day 4|Those participants who received any study medication and had adequate PK profiles were included; 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.||ng*h/mL||90% Confidence Interval|Geometric Mean
649676|NCT02074358|Secondary|Geometric Mean Area Under the Plasma Concentration-Time Curve in One Dosing Interval [AUC(0-12)] of Apixaban on Day 4|Plasma samples for PK analysis were obtained on Day 4 at 0 hour (pre-dose), 0.5, 1, 2, and 3 hours post apixaban dose, and at 0.5, 1, 2, 4, 6, 9 hours post infusion (PCC or Placebo), and at 21, 45, and 69 hours post infusion (Days 5, 6, and 7) in each treatment period. PK parameters were derived from plasma concentration versus time. Concentration of apixaban was determined using a validated LC/MS/MS assay within the period of known analyte stability. AUC(0-12) was measured in ng*hours/mL (ng*h/mL)|Day 4|Those participants who received any study medication and had adequate PK profiles were included; 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
649677|NCT02074358|Secondary|Geometric Mean Time of Maximum Observed Plasma Concentration (Tmax) of Apixaban on Day 4|Plasma samples for PK analysis were obtained on Day 4 at 0 hour (pre-dose), 0.5, 1, 2, and 3 hours post apixaban dose, and at 0.5, 1, 2, 4, 6, 9 hours post infusion (PCC or Placebo), and at 21, 45, and 69 hours post infusion (Days 5, 6, and 7) in each treatment period. PK parameters were derived from plasma concentration versus time. Concentration of apixaban was determined using a validated LC/MS/MS assay within the period of known analyte stability. Tmax was measured in hours.|Day 4|Those participants who received any study medication and had adequate PK profiles were included; 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.||hours||Full Range|Median
649678|NCT02074358|Secondary|Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Apixaban on Day 4|Plasma samples for pharmacokinetic (PK) analysis were obtained on Day 4 at 0 hour (pre-dose), 0.5, 1, 2, and 3 hours post apixaban dose, and at 0.5, 1, 2, 4, 6, 9 hours post infusion (PCC or Placebo), and at 21, 45, and 69 hours post infusion (Days 5, 6, and 7) in each treatment period. PK parameters were derived from plasma concentration versus time. Concentration of apixaban was determined using a validated liquid chromatography tandem mass spectrometry (LC/MS/MS) assay within the period of known analyte stability. Cmax was measured in nanograms per milliliter (ng/mL).|Day 4|Those participants who received any study medication and had adequate PK profiles were included; 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
649679|NCT02074358|Secondary|PD Parameter: Adjusted Mean Change in Coagulation Parameter INR From Day 1 Pre-Dose Apixaban Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo|Coagulation parameters were evaluated by Quintiles Laboratories Europe using an ACL TOP analyzer and Instrumentation Laboratory reagents [HemosIL(Registered) Recombiplastin 2G for PT and Synthasil for aPTT]. A second PT was also measured at Esoterix using a Diagnostica Stago STA Compact coagulation analyzer and Diagnostica Stago reagents STA-Neoplastin CI Plus (Registered). Baseline was Day 1, 0 hour pre-dose apixaban. Samples on Day 4 were obtained at 0 and 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. INR was measured as a fraction|Day 1, pre-dose apixaban (Baseline), Day 4, 30 minutes post infusion.|PD Population included all participants who received any study medication and had PD data available for at least the analysis-specified baseline and 30 minutes after the start of the study drug infusion. 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.||fraction||95% Confidence Interval|Mean
649680|NCT02074358|Secondary|PD Parameter: Adjusted Mean Change in Coagulation Parameters PT and aPTT From Day 1 Pre-Dose Apixaban Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo|Coagulation parameters were evaluated by Quintiles Laboratories Europe using an ACL TOP analyzer and Instrumentation Laboratory reagents [HemosIL(Registered) Recombiplastin 2G for PT and Synthasil for aPTT]. A second PT was also measured at Esoterix using a Diagnostica Stago STA Compact coagulation analyzer and Diagnostica Stago reagents STA-Neoplastin CI Plus (Registered). Baseline was Day 1, pre-apixaban dose. Samples on Day 4 were obtained at 0 and 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period.|Day 1, pre-dose apixaban (Baseline), Day 4, 30 minutes post infusion.|PD Population included all participants who received any study medication and had PD data available for at least the analysis-specified baseline and 30 minutes after the start of the study drug infusion. 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.||seconds||95% Confidence Interval|Mean
649681|NCT02074358|Primary|PD Parameter: Adjusted Mean Change in Endogenous Thrombin Potential (ETP) From Day 1 Pre-Dose Apixaban Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo|ETP was evaluated using a Thrombin Generation Assay (TGA), a validated automated ex vivo assay performed on platelet-poor plasma samples and based on the automated, calibrated thrombin generation method: thrombin formation was triggered with recombinant tissue factor and phospholipids. Thrombin concentration in each sample was calculated over time by measuring the cleavage of a fluorogenic substrate in the context of a paired calibration sample. A dedicated software program (Thrombinoscope, Thrombinoscope B.V., Maastricht, The Netherlands) performed the calculations and derived ETP as area under the curve from the resulting “thrombogram” curve. Pre-dose Apixaban baseline was Day 1 pre-dose (0 hour). Samples on Day 4 were obtained at 0, 0.5, 1, 2, 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period.|Day 1 pre-dose apixaban (pre-apixaban Baseline), Day 4 at 30 minutes post infusion (PCC or Placebo)|PD Population included all participants who received any study medication and had PD data available for at least the analysis-specified baseline and 30 minutes after the start of the study drug infusion. 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.||nM*minute||95% Confidence Interval|Mean
649821|NCT02070640|Primary|Complications Related to ICG|A patient's negative reaction to indocyanine green (ICG) will be monitored from the time of injection through the 2 week post-operative follow-up visit.|From time of injection to 1st post-op follow-up|||% of Participants with Complications|||Number
649682|NCT02074358|Secondary|PD Parameter: Adjusted Mean Change in TGA Velocity Index From Day 1 Pre-Dose Apixaban Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo|TGA is a validated, automated ex vivo assay performed on platelet-poor plasma samples and based on the automated, calibrated thrombin generation method: thrombin formation was triggered with recombinant tissue factor and phospholipids and the concentration in each sample was calculated over time by measuring the cleavage of a fluorogenic substrate in the context of a paired calibration sample; dedicated software program was Thrombinoscope, B.V., Maastricht, The Netherlands. Baseline was Day 1, 0 hour (pre-dose apixaban). Samples on Day 4 were obtained at 0, 0.5, 1, 2, 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. TGA velocity index was measured in nM/min.|Day 1, pre-dose apixaban (Baseline), Day 4, 30 minutes post infusion.|PD Population included all participants who received any study medication and had PD data available for at least the analysis-specified baseline and 30 minutes after the start of the study drug infusion. 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.||nM/min||95% Confidence Interval|Mean
649683|NCT02074358|Secondary|PD Parameter: Adjusted Mean Change in TGA Peak Height From Day 1 Pre-Dose Apixaban Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo|TGA is a validated, automated ex vivo assay performed on platelet-poor plasma samples and based on the automated, calibrated thrombin generation method: thrombin formation was triggered with recombinant tissue factor and phospholipids and the concentration in each sample was calculated over time by measuring the cleavage of a fluorogenic substrate in the context of a paired calibration sample; dedicated software program was Thrombinoscope, B.V., Maastricht, The Netherlands. Baseline was Day 1, 0 hour pre-dose apixaban. Samples on Day 4 were obtained at 0, 0.5, 1, 2, 3 hours post apixaban dose and 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. TGA Lag Time and Time to Peak parameters were measured in minutes.|Day 1, pre-dose apixaban (Baseline), Day 4, 30 minutes post infusion.|PD Population included all participants who received any study medication and had PD data available for at least the analysis-specified baseline and 30 minutes after the start of the study drug infusion. 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.||nM||95% Confidence Interval|Mean
649684|NCT02074358|Secondary|PD Parameter: Adjusted Mean Change in TGA Lag Time and TGA Time to Peak From Day 1 Pre-Dose Apixaban Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo|TGA is a validated, automated ex vivo assay performed on platelet-poor plasma samples and based on the automated, calibrated thrombin generation method: thrombin formation was triggered with recombinant tissue factor and phospholipids and the concentration in each sample was calculated over time by measuring the cleavage of a fluorogenic substrate in the context of a paired calibration sample; dedicated software program was Thrombinoscope, B.V., Maastricht, The Netherlands. Baseline was Day 1, 0 hour pre-dose apixaban. Samples on Day 4 were obtained at 0, 0.5, 1, 2, 3 hours post apixaban dose and 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. TGA Lag Time and Time to Peak parameters were measured in minutes.|Day 1, pre-dose apixaban (Baseline), Day 4, 30 minutes post infusion.|PD Population included all participants who received any study medication and had PD data available for at least the analysis-specified baseline and 30 minutes after the start of the study drug infusion. 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.||minutes||95% Confidence Interval|Mean
649685|NCT02074358|Secondary|PD Parameter: Adjusted Mean Change in Plasma Anti-Xa Activity From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo|Anti-FXa activity was measured using a validated method at Esoterix Coagulation Laboratory (Englewood, CO) using the Diagnostica Stago Rotachrom (Registered) Heparin assay on a STA-Compact (Registered) analyzer. Samples on Day 4 were obtained at 0, 0.5, 1, 2, 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. The results of this chromogenic assay were reported in low molecular weight heparin (LMWH) activity units per milliliter (U/mL), which are equivalent to international units per milliliter (IU/mL) with assay reportable range: 0.1 to 18.4 IU/mL.|Day 4 at 3 hours post apixaban dose and prior to infusion (Pre-infusion Baseline), Day 4 at 30 minutes post infusion.|PD Population included all participants who received any study medication and had PD data available for at least the analysis-specified baseline and 30 minutes after the start of the study drug infusion. 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.||U/mL||95% Confidence Interval|Mean
649686|NCT02074358|Secondary|PD Parameter: Adjusted Mean Change in Coagulation Parameter International Normalized Ratio (INR) From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo|Coagulation parameters were evaluated by Quintiles Laboratories Europe using an ACL TOP analyzer and Instrumentation Laboratory reagents [HemosIL(Registered) Recombiplastin 2G for PT and Synthasil for aPTT]. A second PT was also measured at Esoterix using a Diagnostica Stago STA Compact coagulation analyzer and Diagnostica Stago reagents STA-Neoplastin CI Plus (Registered). Samples on Day 4 were obtained at 0 and 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. INR was measured as a fraction.|Day 4 at 3 hours post apixaban dose and prior to infusion (Pre-infusion Baseline), Day 4 at 30 minutes post infusion.|PD Population included all participants who received any study medication and had PD data available for at least the analysis-specified baseline and 30 minutes after the start of the study drug infusion. 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.||fraction||95% Confidence Interval|Mean
649693|NCT02074345|Secondary|Percentage of Participant With Anti-PRP Antibody Titer ≥ 0.15 μg/mL|Blood was collected and was sent to a central laboratory for the evaluation of anti-PRP antibody titer against Hib as an assessment of immunogenicity.|For 64 weeks|FAS, all participants who received at least 1 dose of the study vaccination, with available data.||percentage of participants||95% Confidence Interval|Number
649694|NCT02074345|Secondary|Percentage of Participant With Anti-PRP Antibody Titer ≥ 1.0 μg/mL|Blood was collected and was sent to a central laboratory for the evaluation of anti-PRP antibody titer against Haemophilus influenzae type b (Hib) as an assessment of immunogenicity.|For 64 weeks|FAS, all participants who received at least 1 dose of the study vaccination, with available data.||percentage of participants||95% Confidence Interval|Number
649822|NCT02070588|Secondary|Operator Set MRI Parameters|To record operator-adjusted parameters of the novel software on the MRI system|Per-patient 1 to 3 months, until dataset completion 1 yr|Study was terminated and no subject outcome data were collected|||||
649687|NCT02074358|Secondary|PD Parameter: Adjusted Mean Change in Coagulation Parameters Prothrombin Time (PT) and Activated Partial Thromboplastin Time (aPTT) From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo|Coagulation parameters were evaluated by Quintiles Laboratories Europe using an ACL TOP analyzer and Instrumentation Laboratory reagents [HemosIL(Registered) Recombiplastin 2G for PT and Synthasil for aPTT]. A second PT was also measured at Esoterix using a Diagnostica Stago STA Compact coagulation analyzer and Diagnostica Stago reagents STA-Neoplastin CI Plus (Registered). Samples on Day 4 were obtained at 0 and 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. PT (Neoplastin CT+), PT (Recombiplastin 2G) and activated partial thromboplastin time (aPTT) parameters were measured in seconds.|Day 4 at 3 hours post apixaban dose and prior to infusion (Pre-infusion Baseline), Day 4 at 30 minutes post infusion.|PD Population included all participants who received any study medication and had PD data available for at least the analysis-specified baseline and 30 minutes after the start of the study drug infusion. 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.||seconds||95% Confidence Interval|Mean
649688|NCT02074358|Secondary|PD Parameter: Adjusted Mean Change in TGA Velocity Index From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo|TGA is a validated automated ex vivo assay performed on platelet-poor plasma samples and based on the automated, calibrated thrombin generation method: thrombin formation was triggered with recombinant tissue factor and phospholipids and the concentration in each sample was calculated over time by measuring the cleavage of a fluorogenic substrate in the context of a paired calibration sample; dedicated software program was Thrombinoscope, B.V., Maastricht, The Netherlands. Samples on Day 4 were obtained at 0, 0.5, 1, 2, 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. TGA Velocity Index parameter was measured in nM per minute (nM/min).|Day 4 at 3 hours post apixaban dose and prior to infusion (Pre-infusion Baseline), Day 4 at 30 minutes post infusion.|PD Population included all participants who received any study medication and had PD data available for at least the analysis-specified baseline and 30 minutes after the start of the study drug infusion. 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.||nM/min||95% Confidence Interval|Mean
649689|NCT02074358|Secondary|PD Parameter: Adjusted Mean Change in TGA Peak Height From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo|TGA is a validated automated ex vivo assay performed on platelet-poor plasma samples and based on the automated, calibrated thrombin generation method: thrombin formation was triggered with recombinant tissue factor and phospholipids and the concentration in each sample was calculated over time by measuring the cleavage of a fluorogenic substrate in the context of a paired calibration sample; dedicated software program was Thrombinoscope, B.V., Maastricht, The Netherlands. Samples on Day 4 were obtained at 0, 0.5, 1, 2, 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. Peak height parameter was measured in nanomolar (nM).|Day 4 at 3 hours post apixaban dose and prior to infusion (Pre-infusion Baseline), Day 4 at 30 minutes post infusion.|PD Population included all participants who received any study medication and had PD data available for at least the analysis-specified baseline and 30 minutes after the start of the study drug infusion. 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.||nM||95% Confidence Interval|Mean
649690|NCT02074358|Secondary|PD Parameters: Adjusted Mean Change in TGA Lag Time and Adjusted Mean Change in TGA Time to Peak From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo|TGA is a validated automated ex vivo assay performed on platelet-poor plasma samples and based on the automated, calibrated thrombin generation method: thrombin formation was triggered with recombinant tissue factor and phospholipids and the concentration in each sample was calculated over time by measuring the cleavage of a fluorogenic substrate in the context of a paired calibration sample; dedicated software program was Thrombinoscope, B.V., Maastricht, The Netherlands. Samples on Day 4 were obtained at 0, 0.5, 1, 2, 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. Lag Time and Time to Peak parameters were measured in minutes.|Day 4 at 3 hours post apixaban dose and prior to infusion (Pre-infusion Baseline), Day 4 at 30 minutes post infusion.|PD Population included all participants who received any study medication and had PD data available for at least the analysis-specified baseline and 30 minutes after the start of the study drug infusion. 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.||minutes||95% Confidence Interval|Mean
649691|NCT02074358|Primary|Pharmacodynamic (PD) Parameter: Adjusted Mean Change in Endogenous Thrombin Potential (ETP) From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo|ETP was evaluated using a Thrombin Generation Assay (TGA), a validated automated ex vivo assay performed on platelet-poor plasma samples and based on the automated, calibrated thrombin generation method: thrombin formation was triggered with recombinant tissue factor and phospholipids. Thrombin concentration in each sample was calculated over time by measuring the cleavage of a fluorogenic substrate in the context of a paired calibration sample. Dedicated software (Thrombinoscope, Thrombinoscope B.V., Maastricht, The Netherlands) performed the calculations and derived ETP as area under the curve from the resulting “thrombogram” curve. Pre-infusion baseline= sample on Day 4, 3 hours post apixaban dose (just prior to IV infusion of PCC or placebo). Samples on Day 4 were obtained at 0 (pre-dose), 0.5, 1, 2, 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. ETP was measured as nanomolar*minute (nM*min).|Day 4 at 3 hours post apixaban dose and prior to infusion (Pre-infusion Baseline), Day 4 at 30 minutes post infusion (PCC or Placebo)|PD Population included all participants who received any study medication and had PD data available for at least the analysis-specified baseline and 30 minutes after the start of the study drug infusion. 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.||nM*min||95% Confidence Interval|Mean
649692|NCT02074345|Secondary|Geometric Mean Titer (GMT) of Anti-PRP Antibody|Blood was collected and was sent to a central laboratory for the evaluation of anti-PRP antibody titer against Hib as an assessment of immunogenicity.|For 64 weeks|FAS, all participants who received at least 1 dose of the study vaccination, with available data.||μg/mL||95% Confidence Interval|Geometric Mean
662135|NCT01828476|Secondary|Measurable Tumor Response in Patients With Measurable Disease||5 years|Study was terminated early and insufficent data was collected to assess this outcome measure.|||||
649695|NCT02074345|Primary|Number of Participants With Adverse Reactions Related to Systemic Reactions|Systemic Reactions were assessed 14 days after each vaccination and were recorded by the caregiver in a diary. Systemic reactions were rash, irritability, crying, decreased appetite, vomiting, diarrhoea, somnolence (sleepiness) and insomnia (sleeplessness).|For 64 Weeks|FAS included all participants who received at least 1 dose of the study vaccination.||participants|||Number
649696|NCT02074345|Primary|Number of Participants With Adverse Reactions Related to Local Reactions|Local Reactions were assessed 14 days after each vaccination and were recorded by the caregiver in a diary. Local reactions (injection site) were erythema, swelling, induration and pain (tenderness).|For 64 Weeks|FAS included all participants who received at least 1 dose of the study vaccination.||participants|||Number
649697|NCT02074345|Primary|Number of Participants With Adverse Reactions Related to Body Temperature (Pyrexia)|Body temperature was assessed for 14 days after each vaccination and was recorded by the caregiver in a diary. Adverse reactions related body temperature was reported as pyrexia.|For 64 Weeks|FAS included all participants who received at least 1 dose of the study vaccination.||participants|||Number
649698|NCT02074345|Primary|Number of Participants With Adverse Events|Adverse events are defined as unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product, regardless of relationship to the medicinal product. Among these, events which are considered possibly associated with a medicinal product are defined as adverse reactions.|For 64 Weeks|Full Analysis Set (FAS) included all participants who received at least 1 dose of the study vaccination.||participants|||Number
649699|NCT02074059|Secondary|PCO2|Arterial carbon dioxide|Within 3 Hours of Randomization|Safety Population||percentage of arterial carbon dioxide||Standard Deviation|Mean
649700|NCT02074059|Primary|Serum Electrolytes||24 Hours Post Randomization|All randomized subjects||mEq/L||Standard Deviation|Mean
649701|NCT02074059|Primary|Oxygen Saturation Levels|Oxygen saturation as determined by pulse oximetry|Within 3 Hours of Randomization|Safety Population||percentage of oxygen saturation||Standard Deviation|Mean
649702|NCT02074059|Primary|All Cause Mortality||Within 36 Weeks PMA|Safety Population||participants|||Number
649703|NCT02074059|Primary|Peri-Dosing Events|Pre-specified adverse events that occured during treatment administration; does not include nCPAP alone|Within 48 Hours after Initiation of Study Treatment|Safety Population||participants|||Number
649704|NCT02073747|Primary|Number of Subjects With a Change From Baseline Serum Lactate Following a One Hour Albuterol Nebulizer Treatment.|We powered our study to detect a difference of 0.5 mmol/L between pre and post-treatment lactate levels, but hypothesize that the difference will be greater than 1.0 mmol/L.|Change in serum lactate from baseline to 1 hour|||mmol/L||95% Confidence Interval|Mean
649705|NCT02073656|Secondary|For Participants in the Retreatment Substudy, Percentage of Participants With Virologic Failure|"Virologic failure was defined as:
On-treatment virologic failure:
Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)
Virologic relapse:
Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 24 of Retreatment Substudy|Participants in the Full Analysis Set who entered the Retreatment Substudy were analyzed.||percentage of participants|||Number
649706|NCT02073656|Secondary|For Participants in the Retreatment Substudy, Change From Baseline in HCV RNA at Retreatment Weeks 2, 4, and 8||Baseline; Weeks 2, 4, and 8 of Retreatment Substudy|Participants in the Full Analysis Set who entered the Retreatment Substudy were analyzed.||log10 IU/mL||Standard Deviation|Mean
649707|NCT02073656|Secondary|For Participants in the Retreatment Substudy, Percentage of Participants With HCV RNA < LLOQ at Retreatment Weeks 2, 4, 8, 12, 16, 20, and 24||Weeks 2, 4, 8, 12, 16, 20, and 24 of the Retreatment Substudy|Participants in the Full Analysis Set who entered the Retreatment Substudy were analyzed.||percentage of participants||95% Confidence Interval|Number
649708|NCT02073656|Secondary|For Participants in the Retreatment Substudy, Percentage of Participants With SVR at 4, 12, and 24 Weeks After Discontinuation of Therapy (SVR4, SVR12, and SVR24)|SVR4, SVR12, and SVR 24 were defined as HCV RNA < LLOQ at 4, 12, and 24 weeks after stopping study treatment, respectively.|Posttreatment Weeks 4, 12, and 24 of Retreatment Substudy|Participants in the Full Analysis Set who entered the Retreatment Substudy were analyzed.||percentage of participants||95% Confidence Interval|Number
649709|NCT02073656|Secondary|Change From Baseline in Serum Creatinine at the End of Treatment (Week 12) and at Posttreatment Weeks 12 and 24||Baseline; Week 12, Posttreatment Weeks 12 and 24|Participants in the Safety Analysis Set with available data were analyzed.||mg/dL||Standard Deviation|Mean
649710|NCT02073656|Secondary|Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL While on HCV Treatment||Weeks 4, 8, and 12|Participants in the Safety Analysis Set with available data were analyzed.||percentage of participants|||Number
649711|NCT02073656|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as:
On-treatment virologic failure:
Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)
Virologic relapse:
Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 24|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants|||Number
649712|NCT02073656|Secondary|Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, and 8||Baseline; Weeks 1, 2, 4, 6, and 8|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
649713|NCT02073656|Secondary|Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12||Weeks 1, 2, 4, 6, 8, 10, and 12|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants||95% Confidence Interval|Number
649714|NCT02073656|Secondary|Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set||percentage of participants||95% Confidence Interval|Number
649715|NCT02073656|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 12 weeks|Safety Analysis Set: participants who enrolled and received at least 1 dose of study drug.||percentage of participants|||Number
649716|NCT02073656|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants who enrolled and received at least 1 dose of study drug.||percentage of participants||95% Confidence Interval|Number
649717|NCT02073461|Secondary|Local Tolerability (Stinging/Burning)|Highest severity of local tolerability scores worse than Baseline|12 weeks|||participants|||Number
649718|NCT02073461|Secondary|Local Tolerability (Pruritus)|Highest severity of local tolerability scores worse than Baseline|12 weeks|||participants|||Number
649719|NCT02073461|Secondary|Local Tolerability (Dryness)|Highest severity of local tolerability scores worse than Baseline|12 weeks|||participants|||Number
649720|NCT02073461|Secondary|Local Tolerability (Scaling)|Highest severity of local tolerability scores worse than Baseline|12 weeks|||participants|||Number
649721|NCT02073461|Secondary|Local Tolerability (Erythema)|Highest severity of local tolerability scores worse than Baseline|12 weeks|||participants|||Number
649722|NCT02073461|Secondary|Percent of Subjects With Adverse Events|Adverse events which were observed in 5% or more patients with either group are listed.|up to 12 weeks|||percentage of participants|||Number
649723|NCT02073461|Primary|Percent Changes From Baseline in Total Lesion Counts|Median percent reductions from Baseline in total lesion count (ITT-LOCF)|Baseline - Week 12|||percent change||Full Range|Median
649724|NCT02073448|Secondary|Local Tolerability (Stinging/Burning)|Highest severity of local tolerability scores worse than Baseline|12 weeks|||participants|||Number
649725|NCT02073448|Secondary|Local Tolerability (Pruritus)|Highest severity of local tolerability scores worse than Baseline|12 weeks|||participants|||Number
649726|NCT02073448|Secondary|Local Tolerability (Dryness)|Highest severity of local tolerability scores worse than Baseline|12 weeks|||participants|||Number
649727|NCT02073448|Secondary|Local Tolerability (Scaling)|Highest severity of local tolerability scores worse than Baseline|12 weeks|||participants|||Number
649728|NCT02073448|Secondary|Local Tolerability (Erythema)|Highest severity of local tolerability scores worse than Baseline|12 weeks|||participants|||Number
649729|NCT02073448|Secondary|Percent of Subjects With Adverse Events||up to 12 weeks|||percentage of participants|||Number
649730|NCT02073448|Primary|Percent Changes From Baseline in Total Lesion Counts||Baseline - Week12|||percent change||Full Range|Median
649731|NCT02072980|Secondary|Average Coefficient of Friction at 15 Minutes|Worn contact lenses were removed from the participant's eye and the CF was calculated. A lower CF may indicate higher contact lens lubricity. The ex-vivo lubricity was carried out on one lens (one eye) only.|Day 1 (for each period), 15 minutes|This analysis population includes all participants who completed the study.||unitless||Standard Deviation|Mean
649732|NCT02072980|Primary|Average Coefficient of Friction (CF) at 16 Hours Compared to Unworn|Worn contact lenses were removed from the participant's eye. The CF was calculated and compared to the CF for unworn contact lenses. A lower CF may indicate higher contact lens lubricity. The ex-vivo lubricity was carried out on one lens (one eye) only.|Day 1 (for each period), 16 hours|This analysis population includes all participants who completed the study.||unitless||Standard Deviation|Mean
649733|NCT02072421|Secondary|Major Vascular Complications|Major vascular complications, including access site complications and major bleeding events requiring transfusion,through 30 days post-procedure.|30 days|||participants|||Number
649734|NCT02072421|Secondary|Revascularization|Repeat coronary revascularization including emergency or urgent revascularization through 30 days post-procedure|30 days|||participants|||Number
649735|NCT02072421|Secondary|Stroke|Stroke through 30 days post-procedure|30 days|||participants|||Number
649736|NCT02072421|Secondary|All-Cause Mortality|all-cause mortality through 30 days post-procedure|30 days|||participants|||Number
649737|NCT02072421|Primary|Major Adverse Cardiac Event (MACE)|MACE is a composite of all cause mortality, myocardial infarction (Q wave and non-Q wave), repeat coronary revascularization (of the target vessel or non-target vessel) by either percutaneous or coronary artery bypass graft (CABG) methods, or stroke, at 30-days.|30-days|||participants|||Number
649738|NCT02072200|Secondary|Change of Functional Disability Index of the Korea Health Assessment Questionnaire (KHAQ) From Baseline to Week 12|Change in KHAQ score from baseline to Week 12 post-treatment: KHAQ is composed of 8 functional disability indices. The scale for each index is from 0 (without any difficulty) to 3 (unable to do). Scores for each disability index were summed to obtain the total score for each subject, ranging between 0 to 24, with higher scores reflecting higher functional disability. The scores were then averaged across all subjects.|12 weeks|ITT set was 145 patients, but 11 patients data was not assessed except baseline score.||scores on a scale||Standard Deviation|Mean
649739|NCT02072200|Secondary|Change of Baseline Severity of Morning Stiffness at Week 12 Using Visual Analog Scale (VAS) Scale|The VAS is a 100 mm line ranging from 0 mm (no pain) on the left end and 100 mm (worst pain) on the right end. Subjects marked on the line to indicate their pain severity. The distance in mm was measured from the left end to the subject's marking.|Baseline and 12 weeks|ITT population was 145, but 3 patients were not assessed for primary efficacy parameter of morning stiffness severity. So, Last Observation Carried Forward (LOCF) was not done for these 3 patients after baseline . Other patients' missing data were handled using LOCF method.||mm||Standard Deviation|Mean
649740|NCT02072200|Primary|Change From Baseline in Morning Stiffness Duration at Week 12 as Assessed by Patient Diary|"Data for the duration of morning stiffness will be obtained from patient diaries. Duration of morning stiffness will be from wake-up time to time of resolution of morning stiffness.
Relative reduction rate of the morning stiffness duration from baseline to Week 12 of the study drug treatment was calculated for this outcome measure."|Baseline and 12 weeks|ITT set = 145 patients. Missing data was handled as LOCF.||minutes||Standard Deviation|Mean
649741|NCT02072096|Other Pre-specified|Change From Baseline in Mini-mental State Examination (MMSE) Score||Baseline, Week 72|Unable to conduct change from baseline analysis due to study closure and lack of endpoint data.|||||
649742|NCT02072096|Other Pre-specified|Change From Baseline in European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L) Score||Baseline, Week 72|Unable to conduct change from baseline analysis due to study closure and lack of endpoint data.|||||
649743|NCT02072096|Other Pre-specified|Change From Baseline in Adult Low Blood Sugar Survey (ALBSS) Score||Baseline, Week 72|Unable to conduct change from baseline analysis due to study closure and lack of endpoint data.|||||
649744|NCT02072096|Secondary|Change From Baseline of Estimated Glomerular Filtration Rate (eGFR)|The eGFR is used in addition to the Urinary Albumin to Creatinine Ratio to measure the incidence and progression of diabetic kidney disease.|Baseline, Week 72|All participants who received at least one dose of study drug and had evaluable baseline and post-baseline eGFR data.||milliliter per minute/1.73 square meter||Standard Deviation|Mean
649745|NCT02072096|Secondary|Change From Baseline in Body Mass Index (BMI)||Baseline, Week 72|All participants who received at least one dose of study drug and had evaluable baseline and post-baseline BMI data.||kilogram per square meter (kg/m^2)||Standard Deviation|Mean
649746|NCT02072096|Secondary|Change From Baseline of Urinary Albumin to Creatinine Ratio|The Urinary Albumin to Creatinine Ratio is used in addition to Estimated Glomerular Filtration Rate (eGFR) to measure the incidence and progression of diabetic kidney disease.|Baseline, Week 72|All participants who received at least one dose of study drug and had evaluable baseline and post-baseline urinary albumin to creatinine ratio.||milligram per millimole (mg/mmol)||Standard Deviation|Mean
649747|NCT02072096|Secondary|Number of Participants With Total Hypoglycemia and Other Categories of Hypoglycemia||Baseline to last participant visit (up to 72 weeks)|All participants who received at least one dose of study drug.||Participants|||Number
649748|NCT02072096|Secondary|Percentage of Participants Requiring Alternative Treatment Due to Glycemic Failure of First Line Injectable Therapy||Baseline to last participant visit (up to 72 weeks)|All participants who received at least one dose of study drug.||percentage of participants|||Number
649749|NCT02072096|Primary|Percentage of Participants Achieving and Maintaining Individualized Glycated Hemoglobin A1c (HbA1c) Targets Without Clinically Significant Hypoglycemia|Failed to reach and maintain HbA1c target, without clinically significant hypoglycemia, is defined as having 2 consecutive HbA1c > upper limit of HbA1c target over 12 weeks starting from Week 24 for participants with HbA1c data beyond Week 24, or Week 24 HbA1c > upper limit of HbA1c target for participants without HbA1c data beyond Week 24. Clinically significant hypoglycemia is defined as any severe hypoglycemia or repeated hypoglycemia interrupting participants activities or sleep and associated with blood glucose ≤3.9 millimole per liter (mmol/L), or repeated asymptomatic hypoglycemia associated with blood glucose <3.0 mmol/L. Success is defined as lacking of failure.|Baseline to last participant visit (up to 72 weeks)|All participants who received at least one dose of study drug.||percentage of participants||95% Confidence Interval|Number
649750|NCT02071849|Secondary|Cardiac Index - Change From Baseline|Hemodynamic parameter computed as cardiac output divided by body surface area|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.||l/min/m^2||Standard Deviation|Mean
649751|NCT02071849|Secondary|Cardiac Index - Change From Baseline|Hemodynamic parameter computed as cardiac output divided by body surface area|Baseline and 6 months|Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.||l/min/m^2||Standard Deviation|Mean
649752|NCT02071849|Secondary|Cardiac Output - Change From Baseline|Stroke volume x heart rate. Transthoracic echocardiography parameter.|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.||l/min||Standard Deviation|Mean
649753|NCT02071849|Secondary|Cardiac Output - Change From Baseline|Stroke volume x heart rate. Transthoracic echocardiography parameter.|Baseline and 6 months|Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.||l/min||Standard Deviation|Mean
649754|NCT02071849|Secondary|Left Ventricular Ejection Fraction (LVEF) - Change From Baseline|Left ventricular ejection fraction. Transthoracic echocardiography parameter.|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.||percentage of blood volume||Standard Deviation|Mean
649755|NCT02071849|Secondary|Left Ventricular Ejection Fraction (LVEF) - Change From Baseline|Left ventricular ejection fraction. Transthoracic echocardiography parameter.|Baseline and 6 months|Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.||percentage of blood volume||Standard Deviation|Mean
649756|NCT02071849|Secondary|LV Systolic Volume - Change From Baseline|Left ventricular systolic volume. Transthoracic echocardiography parameter.|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.||ml||Standard Deviation|Mean
649757|NCT02071849|Secondary|LV Systolic Volume - Change From Baseline|Left ventricular systolic volume. Transthoracic echocardiography parameter.|Baseline and 6 months|Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.||ml||Standard Deviation|Mean
649758|NCT02071849|Secondary|LV Diastolic Volume - Change From Baseline|Left ventricular diastolic volume. Transthoracic echocardiography parameter.|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.||ml||Standard Deviation|Mean
649759|NCT02071849|Secondary|LV Diastolic Volume - Change From Baseline|Left ventricular diastolic volume. Transthoracic echocardiography parameter.|Baseline and 6 months|Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.||ml||Standard Deviation|Mean
649760|NCT02071849|Secondary|LVID Systole - Change From Baseline|Left ventricular internal dimension. Transthoracic echocardiography parameter.|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.||cm||Standard Deviation|Mean
649761|NCT02071849|Secondary|LVID Systole - Change From Baseline|Left ventricular internal dimension. Transthoracic echocardiography parameter.|Baseline and 6 months|Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.||cm||Standard Error|Mean
649762|NCT02071849|Secondary|LVID Diastole - Change From Baseline|Left ventricular internal dimension. Transthoracic echocardiography parameter.|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.||cm||Standard Deviation|Mean
649763|NCT02071849|Secondary|Left Ventricular Internal Dimension (LVID) Diastole - Change From Baseline|Left ventricular internal dimension. Transthoracic echocardiography parameter.|Baseline and 6 months|Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.||cm||Standard Deviation|Mean
649764|NCT02071849|Secondary|LV Mass - Change From Baseline|Left ventricular mass. Transthoracic echocardiography parameter.|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.||g||Standard Deviation|Mean
649765|NCT02071849|Secondary|Left Ventricular (LV) Mass - Change From Baseline|Left ventricular mass. Transthoracic echocardiography parameter.|Baseline and 6 months|Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.||g||Standard Deviation|Mean
649770|NCT02071849|Secondary|NYHA Functional Capacity Classification|Four classes describing the effect of cardiac disease on physical activity: Class I - disease does not limit activity; Class II - slight limitation; Class III - marked limitation; Class IV - inability to carry out any physical activity without discomfort|2 years postprocedure|Participants with an evaluation of this measure.||Participants|||Count of Participants
649771|NCT02071849|Secondary|New York Heart Association (NYHA) Functional Capacity Classification|Four classes describing the effect of cardiac disease on physical activity: Class I - disease does not limit activity; Class II - slight limitation; Class III - marked limitation; Class IV - inability to carry out any physical activity without discomfort|6 months postprocedure|Participants with an evaluation of this measure.||Participants|||Count of Participants
649772|NCT02071849|Secondary|Aortic Insufficiency (AI) at 2 Years|Aortic insufficiency assessed by transthoracic echocardiography and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+)|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure.||Participants|||Count of Participants
649773|NCT02071849|Secondary|Survival Defined as Survival Free From All Cause Death at 2 Years Postprocedure.||2 years|||percentage of participants||95% Confidence Interval|Number
649774|NCT02071849|Secondary|Actuarial Freedom From Clinical Cardiovascular Events|Freedom from specified clinical cardiovascular events 6 months postprocedure: - Device-related mortality - Complete heart block - Structural device failure - Endocarditis - Periprosthetic leak or dehiscence - Thromboembolism - Bleeding Event - Native Valve Deterioration - Valve Thrombosis - Hemolysis - Reoperation and explant at 6 months|2 years postprocedure|||percentage of participants||95% Confidence Interval|Number
649775|NCT02071849|Secondary|Actuarial Freedom From Clinical Cardiovascular Events|Freedom from specified clinical cardiovascular events 6 months postprocedure: - Device-related mortality - Complete heart block - Structural device failure - Endocarditis - Periprosthetic leak or dehiscence - Thromboembolism - Bleeding Event - Native Valve Deterioration - Valve Thrombosis - Hemolysis - Reoperation and explant at 6 months|6 months postprocedure|||percentage of participants||95% Confidence Interval|Number
649776|NCT02071849|Secondary|Implant Procedure Success|Success is defined as the absence of specified adverse events evaluated through discharge following the procedure: - Aortic annular dissection, rupture, or leaflet damage - Mitral valve impingement due to implant - implant dehiscence/migration into aorta - implant dehiscence/migration into left ventricle - Hemodynamics requiring intervention - Other adverse event resulting in reoperation, explantation, or permanent disability.|discharge or 14 days postprocedure, whichever comes first|||percentage of participants||95% Confidence Interval|Number
649777|NCT02071849|Primary|Primary Efficacy Outcome Measure: Aortic Insufficiency (AI) at 6 Months|Aortic insufficiency assessed by transthoracic echocardiography and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderately Severe (3+), or Severe (4+)|6 months postprocedure|Participants with an echocardiogram evaluable for this measure.||Participants|||Count of Participants
649778|NCT02071849|Primary|Primary Safety Outcome Measure: Survival Defined as Survival Free From All Cause Death at 6 Months Postprocedure.||6 months postprocedure|||percentage of participants||95% Confidence Interval|Number
649779|NCT02071823|Primary|Area Under the Concentration-time Curve Extrapolated to Infinity (AUC∞)|Area Under the Concentration-time Curve Extrapolated to Infinity (AUC∞) for BIA 9-1067|Day 1|||ng·h/mL||Standard Deviation|Mean
649780|NCT02071823|Primary|AUCt - Cumulative Area Under the Plasma Concentration Time Curve|AUCt - Cumulative Area Under the plasma concentration time Curve for BIA 9-1067|Day 1|||ng·h/mL||Standard Deviation|Mean
649781|NCT02071823|Primary|Cmax - Maximum Observed Plasma Concentration|Cmax - Maximum observed plasma concentration of BIA 9-1067|Day 1|||ng/mL||Standard Deviation|Mean
649782|NCT02071810|Primary|Number of Patients With at Least One Adverse Event||participants will be followed for the duration of hospital stay, an expected average of 6 weeks|||Number of patients|||Number
649783|NCT02071771|Secondary|Lens Oscillation at Blink at Day 10|Lens oscillation (rotational stability of the lens on the eye) at blink was video-recorded. Digital images were used to measure the rotational characteristics of the lenses and objectively measure the amplitude of the lens oscillation. A higher value indicates greater lens movement on the eye. This outcome measure was collected at one site only.|Day 10, each product|This analysis group includes all randomized subjects at the UK site with data at visit who had no major protocol violations excluding those who met the critical deviation criteria as specified in the Deviations and Evaluability Plan.||degrees||Standard Deviation|Mean
649784|NCT02071771|Primary|High Contrast Time Controlled Visual Acuity (TCVA) at Day 10|TCVA test was performed at 4 meters under high illumination (90%) using a Landolt ring test. For each acuity level, a series of single rings with gaps in one of four directions was presented and the percentage of correctly identified rings constituted the score. TCVA was measured in VA units and a higher TCVA value indicates an improvement in visual acuity. Both eyes contributed to the analysis.|Day 10, each product|This analysis group includes all randomized subjects who had no major protocol violations excluding those who met the critical deviation criteria as specified in the Deviations and Evaluability Plan.||VA units||Standard Deviation|Mean
649785|NCT02071108|Other Pre-specified|Exploratory Endpoint|The clinical protocol provided for an Exploratory Secondary Endpoint to assess the ability of the device to achieve ≤30% residual stenosis without adjunctive PTA as assessed by the investigator via visual estimate.|Day of Procedure|Per-Protocol Cohort - the group of subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment was successfully completed||percentage of lesions|lesions||Number
649786|NCT02071108|Secondary|Rutherford Clinical Category|Change in Rutherford Clinical Category (RCC) at 6 months. RCC identifies three grades of claudication and three grades of critical limb ischemia ranging from rest pain alone to minor and major tissue loss. Grade I includes Category 0 - Asymptomatic, Category 1 - Mild claudication, Category 2 - Moderate claudication, and Category 3 - Severe claudication. Grade II includes Category 4 - Ischemic rest pain and Category 5 - Minor tissue loss. Grade III includes Category 6 - Ulceration or grangrene. Change of at least 2 categories considered statistically significant.|Baseline and 6 months|Per-Protocol Cohort - the group of subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment was successfully completed||Rutherford Clinical Category||95% Confidence Interval|Mean
653625|NCT01978743|Secondary|Markers of Immune Activation|Change in markers of immune activation and inflammation associated with change to RAL (ie, sCD14, IL-6, hsCRP, D-dimer, CRP, LPS, sCD163, EndoCab)|week 0 and week 8|||pg/ml||Standard Deviation|Mean
649787|NCT02071108|Secondary|Ankle Brachial Index (ABI)|Change in Ankle Brachial Index (ABI) of the target limb at 6 months. The Ankle Brachial Index (ABI) is the systolic pressure at the ankle, divided by the systolic pressure at the arm.|Baseline and 6 months|Per-Protocol Cohort - the group of subjects who were enrolled in the study and where delivery of the Shockwave Medical Lithoplasty treatment was successfully completed||Ankle Brachial Index||95% Confidence Interval|Mean
649788|NCT02071108|Secondary|Patency|Vessel patency at 6 months at Doppler Ultrasound defined as freedom from greater than 50% restenosis (as assessed by Duplex ultrasound peak systolic velocity ratio of =2.5).|6 months|Per-Protocol Cohort - the group of subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment was successfully completed||percentage of lesions|lesions|95% Confidence Interval|Number
649789|NCT02071108|Secondary|Freedom From Target Lesion Revascularization (TLR)|Freedom from Target Lesion Revascularization (TLR) at 6 months|6 months|Per-Protocol Cohort - the group of subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment was successfully completed||percentage of lesions|lesions||Number
649790|NCT02071108|Secondary|Freedom From Major Adverse Events|Freedom from Major Adverse Events at 6 months|6 months|Full Analysis Cohort - All subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment was attempted||percentage of participants|||Number
649791|NCT02071108|Secondary|Rutherford Clinical Category|Change in Rutherford Clinical Category (RCC) at 30 days. RCC identifies three grades of claudication and three grades of critical limb ischemia ranging from rest pain alone to minor and major tissue loss. Grade I includes Category 0 - Asymptomatic, Category 1 - Mild claudication, Category 2 - Moderate claudication, and Category 3 - Severe claudication. Grade II includes Category 4 - Ischemic rest pain and Category 5 - Minor tissue loss. Grade III includes Category 6 - Ulceration or grangrene. Change of at least 2 categories considered statistically significant.|Baseline and 30 days|Per-Protocol Cohort - the group of subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment was successfully completed||change in RCC from baseline||95% Confidence Interval|Mean
649792|NCT02071108|Secondary|Ankle Brachial Index (ABI)|Change in Ankle Brachial Index (ABI) of the target limb at 30 days. The Ankle Brachial Index (ABI) is the systolic pressure at the ankle, divided by the systolic pressure at the arm.|Baseline and 30 days|Per-Protocol Cohort - the group of subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment was successfully completed. Four subjects were not included in the analysis because ABI could not be measured due to non-compressible disease that inhibited accurate ABI measurement.||change in ABI score from baseline||95% Confidence Interval|Mean
649793|NCT02071108|Secondary|Patency|Vessel patency at 30 days by Doppler Ultrasound defined as freedom from greater than 50% restenosis (as assessed by Duplex ultrasound peak systolic velocity ratio of ≥2.5).|30 days|Full Analysis Cohort - All subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment was attempted. Due to device malfunctions, one subject received partial treatment. To provide a more accurate account of actual device usage, the subject was omitted from the analysis of device usage only.||percentage of lesions|lesions|95% Confidence Interval|Number
649794|NCT02071108|Secondary|Freedom From Target Lesion Revascularization (TLR)|Freedom from Target Lesion Revascularization (TLR) at 30 days|30 days|Per-Protocol Cohort - the group of subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment was successfully completed||percentage of lesions|lesions||Number
649795|NCT02071108|Secondary|Freedom From Major Adverse Events|Freedom from Major Adverse Events at 30 days.|30 days|Full Analysis Cohort - All subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment was attempted||percentage of participants|||Number
649796|NCT02071108|Secondary|Technical Success:|The ability of the Shockwave Medical Lithoplasty System to delivery ShockWave treatment to the desired location in the target vessel. Up to two Shockwave Medical Lithoplasty Systems maybe used to complete treatment in the target vessel.|Day of Procedure|Full Analysis Cohort - All subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment was attempted||percentage of lesions|lesions|95% Confidence Interval|Number
649797|NCT02071108|Secondary|Clinical Success:|The ability of the Shockwave Medical Lithoplasty System to achieve a post-Shockwave residual diameter stenosis of <50% (with or without adjunctive percutaneous transluminal angioplasty therapy) as assessed by the investigator via visual estimate and freedom from procedural major adverse events.|Day of Procedure|Full Analysis Cohort - All subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment was attempted||percentage of participants||95% Confidence Interval|Number
649798|NCT02071108|Secondary|Device Success|The ability of the Shockwave Medical Lithoplasty System to achieve a post-Shockwave residual diameter stenosis of <50% (without adjunctive percutaneous transluminal angioplasty therapy) as assessed via quantitative angiography via core lab evaluation.|Day of Procedure|Full Analysis Cohort - All subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment attempted||percentage of lesions|lesions|95% Confidence Interval|Number
649799|NCT02071108|Primary|Procedural Success:|The ability of the Shockwave Medical Lithoplasty System to achieve a post-Shockwave residual diameter stenosis of <50% (with or without adjunctive Percutaneous Transluminal Angioplasty therapy) as assessed by quantitative angiography via core lab evaluation.|Day of Procedure|Full Analysis Cohort - All subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment was attempted.||percentage of lesions|lesions|95% Confidence Interval|Number
649800|NCT02071108|Primary|Composite of New-onset Major Adverse Events (MAE)|Need for emergency surgical revascularization of target limb. Unplanned target limb amputation (above the ankle). Symptomatic thrombus or distal emboli, defined as clinical signs or symptoms of thrombus or distal emboli detected in the treated limb in the area of the treated lesion, or distal to the treated lesion, after the index procedure or noted angiographically, and requiring mechanical or pharmacologic means to improve flow. Perforations and dissections of grade D or greater that require an intervention to resolve, including bail-out stenting.|30 days|||participants|||Number
650942|NCT02039687|Secondary|Frequency of Adverse Events, Serious Adverse Events, and Laboratory Parameters|Patients reporting at least one treatment emergent adverse event (TEAE) or serious TEAE|Continuous reporting from baseline through 16 weeks|||Participants|||Count of Participants
649802|NCT02071082|Secondary|Change From Baseline in FibroTest® Score at Week 24|The FibroTest® score is used to assess liver fibrosis. Scores range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis.|Baseline; Week 24|Participants in the Full Analysis Set with available data were analyzed.||units on a scale||Inter-Quartile Range|Median
649803|NCT02071082|Secondary|Percentage of Participants With Seroconversion to Anti-HBe at Week 48|Seroconversion to antibody is defined as (1) antigen loss and (2) positive postbaseline antibody value. Missing = excluded method.|Baseline; Week 48|Participants in the Full Analysis Set with available data were analyzed who had positive antigen and negative antibody at baseline.||percentage of participants|||Number
649804|NCT02071082|Secondary|Percentage of Participants With Seroconversion to Hepatitis B e Antibody (Anti-HBe) at Week 24|Seroconversion to antibody is defined as (1) antigen loss and (2) positive postbaseline antibody value. Missing = excluded method.|Baseline; Week 24|Participants in the Full Analysis Set with available data were analyzed who had positive antigen and negative antibody at baseline.||percentage of participants|||Number
649805|NCT02071082|Secondary|Percentage of Participants With Seroconversion to Anti-HBs at Week 48|Seroconversion to antibody is defined as (1) antigen loss and (2) positive postbaseline antibody value. Missing = excluded method.|Baseline; Week 48|Participants in the Full Analysis Set with available data were analyzed who had positive antigen and negative antibody at baseline.||percentage of participants|||Number
649806|NCT02071082|Secondary|Percentage of Participants With Seroconversion to Hepatitis B Surface Antibody (Anti-HBs) at Week 24|Seroconversion to antibody is defined as (1) antigen loss and (2) positive postbaseline antibody value. Missing = excluded method.|Baseline; Week 24|Participants in the Full Analysis Set with available data were analyzed who had positive antigen and negative antibody at baseline.||percentage of participants|||Number
649807|NCT02071082|Secondary|Percentage of Participants With Normalized ALT at Week 48|ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit.|Baseline; Week 48|Participants in the Full Analysis Set who had ALT values above the normal range at baseline were analyzed.||percentage of participants|||Number
649808|NCT02071082|Secondary|Percentage of Participants With Normalized Alanine Aminotransferase (ALT) at Week 24|ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit.|Baseline; Week 24|Participants in the Full Analysis Set who had ALT values above the normal range at baseline were analyzed.||percentage of participants|||Number
649809|NCT02071082|Secondary|Percentage of Participants With Plasma HBV DNA Levels < 29 IU/mL|The percentage of participants with HBV DNA < 29 IU/mL at Week 48 was calculated using the missing = failure method.|Week 48|Full Analysis Set||percentage of participants|||Number
649810|NCT02071082|Secondary|Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Full Analysis Set||percentage of participants|||Number
649811|NCT02071082|Primary|Percentage of Participants With Plasma HBV DNA Levels < 29 IU/mL|The percentage of participants with HBV DNA < 29 IU/mL at Week 24 was calculated using the missing = failure method.|Week 24|Full Analysis set||percentage of participants|||Number
649812|NCT02071082|Primary|Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 24|Full Analysis Set: participants who were enrolled, received at least 1 dose of study drug, had at least 1 post-Day 1 plasma HBV DNA or HIV-1 RNA result while on study, and had no major protocol violations from the eligibility criteria.||percentage of participants|||Number
649813|NCT02070965|Primary|The Number of Subjects With HPA Axis Suppression||Day 15|Three subjects in the 28 day DFD01 Treatment Group, three subjects in the 14 day Comp01 Treatment Group, and one subject in the 14 day DFD01 Treatment Group did not have ACTH stimulation test results.||Participants|||Count of Participants
649814|NCT02070692|Secondary|Number of Participants Experiencing Ovulation After First Use of Study Drug|A third secondary objective is to determine whether taking tamoxifen at this dose compromises ovulation suppression in ENG users. Tamoxifen is known to transiently raise serum estradiol levels, but does not affect gonadotropin release in premenopausal women. Therefore, it is unlikely to interact with the ovulation suppression provided by the implant. However, to further investigate any theoretical interaction between tamoxifen and etonogestrel, urine markers of ovulation will be collected to document ongoing ovulation suppression with intermittent tamoxifen use.|30 days|Number of subjects analyzed are those that provided urine samples. No subject who provided urine samples was excluded from this analysis.||Participants|||Count of Participants
649815|NCT02070692|Secondary|Satisfaction (as Recorded on a 100mm Visual Analog Scale Where 0 is Not at All Satisfied and 100mm is Completely Satisfied)|Secondary objective is to determine whether tamoxifen can improve satisfaction with the implant and with bleeding patterns.|180 days|Number of subjects analyzed is the number of subjects who completed a final study visit (either completion of full study or early termination visit) to provide a final estimation of satisfaction.||units on a scale||Standard Deviation|Mean
649816|NCT02070692|Primary|Consecutive Bleeding-free Days After Study Drug|Consecutive bleeding-free days after study drug|up to 180 days|Number of subjects analyzed is the number of subjects who started taking the study drug. One subject in the tamoxifen arm and there in the placebo arm did not initiate study drug.||days||Standard Deviation|Mean
649817|NCT02070692|Primary|Bleeding/Spotting Days|Bleeding/spotting days|30 days|Number of patients analyzed is number of patients who completed 30 days of follow up. Two subjects in the tamoxifen arm and three in the placebo arm were lost to follow up prior to 30 days.||days||Standard Deviation|Mean
649818|NCT02070692|Primary|Bleeding Days|The primary objective of this study is to determine whether tamoxifen taken by users of the ENG implant on an as-needed basis for frequent or prolonged bleeding can reduce the number of bleeding days by at least 40% over 180 days, when compared to placebo.|180 days|||days||Standard Deviation|Mean
649819|NCT02070640|Secondary|Time to Complete NIRF-C and IOC|The time required to complete NIRF-C and intraoperative cholangiography will be analyzed.|Intraoperative|||minutes||Full Range|Mean
649823|NCT02070588|Secondary|Subject Demographics|To comprehensively collect subject information (i.e. baseline health data, demographics, socioeconomics, injury presentation, post-injury status, and injury type, place, and cause) for mTBI subjects in context of MRI data.|Per-patient 1 to 3 months, until dataset completion 1 yr|Study was terminated and no subject outcome data were collected|||||
649824|NCT02070588|Primary|mTBI Progression Indicated by Clinical Neurological Characteristics, MRI Images, and Quantitative MRI Data From Novel Software|To determine associations between clinical neurological data, MR images, quantitative data from novel software post-processing (sponsor developed software including volumetry, Resting State [RS] functional magnetic resonance imaging [fMRI], kurtosis).|Per-patient 1 to 3 months, until dataset completion 1 yr|Study was terminated and no subject outcome data were collected|||||
649825|NCT02070380|Secondary|Lesion-brain Contrast-to-noise Ratio|"The Unit of Measure is contrast-to-noise ratio based on lesions assessed. For each lesion, Lesion-brain Contrast-to-noise Ratio (CNR) = [(SI of lesion - SI of brain)/SD for SI of noise] on Postdose Images of each lesion was calculated for each contrast agent image separately, then the difference in CNR between MultiHance and Dotarem was calculated. The number presented in the result table below is the mean difference in CNR (MultiHance - Dotarem)"|5-10 minutes Postdose|||ratio based on lesions assessed|Lesions|Standard Deviation|Mean
649826|NCT02070380|Secondary|Lesion to Background Ratio on Post T1-weighed Spin Echo Images|The Unit of Measure is lesion-to-background ratio based on lesions assessed. For each lesion, Lesion-to-background ratio (LBR) = SI of lesion/SI of brain. Firstly, LBR of each lesion was assessed for each contrast agent postdose image separately, then the difference in LBR between MultiHance and Dotarem was calculated. The number presented in the result table below is “the mean difference in LBR postdose (MultiHance – Dotarem)”|5-10 minutes Postdose|||ratio based on lesions assessed|Lesions|Standard Deviation|Mean
649827|NCT02070380|Secondary|Lesion Contrast Enhancement|Assessed by 3 blinded readers for each of the 159 patients who had post-dose exams for both MultiHance, 0.1 mmol/kg and 0.05 mmol/kg doses, and Dotarem 0.1 mmol/kg. Readers assessed whether images with MultiHance were preferred or images with Dotarem were preferred, or whether images after both exams were considered equal. An image set deemed technically inadequate by a blinded reader was excluded from efficacy analysis for that specific reader. Therefore, the number of participant exams evaluated by each reader differed slightly across readers and endpoints.|Comparison of image sets obtained within 2 to 14 days|||Participant Exams|||Number
649828|NCT02070380|Secondary|Extent of Disease|Assessed by 3 blinded readers for each of the 159 patients who had post-dose exams for both MultiHance, 0.1 mmol/kg and 0.05 mmol/kg doses, and Dotarem 0.1 mmol/kg. Readers assessed whether images with MultiHance were preferred or images with Dotarem were preferred, or whether images after both exams were considered equal. An image set deemed technically inadequate by a blinded reader was excluded from efficacy analysis for that specific reader. Therefore, the number of participant exams evaluated by each reader differed slightly across readers and endpoints.|Comparison of image sets obtained within 2 to 14 days|||participant exams|||Number
649829|NCT02070380|Secondary|Lesion Internal Morphology|Assessed by 3 blinded readers for each of the 159 patients who had post-dose exams for both MultiHance, 0.1 mmol/kg and 0.05 mmol/kg doses, and Dotarem 0.1 mmol/kg. Readers assessed whether images with MultiHance were preferred or images with Dotarem were preferred, or whether images after both exams were considered equal. An image set deemed technically inadequate by a blinded reader was excluded from efficacy analysis for that specific reader. Therefore, the number of participant exams evaluated by each reader differed slightly across readers and endpoints.|Comparison of image sets obtained within 2 to 14 days|||participant exams|||Number
649830|NCT02070380|Secondary|Lesion Border Delineation|Assessed by 3 blinded readers for each of the 159 patients who had post-dose exams for both MultiHance, 0.1 mmol/kg and 0.05 mmol/kg doses, and Dotarem 0.1 mmol/kg. Readers assessed whether images with MultiHance were preferred or images with Dotarem were preferred, or whether images after both exams were considered equal. An image set deemed technically inadequate by a blinded reader was excluded from efficacy analysis for that specific reader. Therefore, the number of participant exams evaluated by each reader differed slightly across readers and endpoints.|Comparison of image sets obtained within 2 to 14 days|||participant exams|||Number
649831|NCT02070380|Primary|Global Diagnostic Preference Between the Two Exams|Assessed by 3 blinded readers for each of the 159 patients who had post-dose exams for both MultiHance, 0.1 mmol/kg and 0.05 mmol/kg doses, and Dotarem 0.1 mmol/kg. Readers assessed whether images with MultiHance were preferred or images with Dotarem were preferred, or whether images after both exams were considered equal. An image set deemed technically inadequate by a blinded reader was excluded from efficacy analysis for that specific reader. Therefore, the number of participant exams evaluated by each reader differed slightly across readers and endpoints.|Comparison of image sets obtained within 2 to 14 days|Per Protocol=patients who completed both exams, had global paired image data available, and had no major protocol violations||participant exams|||Number
649832|NCT02070302|Primary|Change From Baseline Jamar Pinch (Unrelated Dominant Hand - Mean Value of All Repetitions/Positions) at Weeks 6, 12,18.|Mean value of one finger and two finger opposition pinch between 1st and 5th and 1st with 4th and 5th phalanges.|Baseline-Week 18|||Pounds of Force (LBF)||Standard Deviation|Mean
649833|NCT02070302|Primary|Change From Baseline Electrodiagnostics Motor Median Nerve Latency at Week 6, Week 12, and Week 18.|Latency is the interval between the stimulation of a muscle and the observed response measuring nerve conduction speed in milliseconds.|Baseline to Week 18|||milliseconds||Standard Deviation|Mean
649834|NCT02070302|Primary|Change From Baseline Electrodiagnostics Distal Sensory Median Nerve Latency at Week 6, Week 12, and Week 18.|Latency is the interval between the stimulation of a muscle and the observed response, measuring conduction speed in milliseconds compared to baseline|Baseline, week 6, week 12, and week 18.|||milliseconds||Standard Deviation|Mean
649835|NCT02070302|Primary|Change From Baseline in Median Nerve Compression on Neuromuscular Ultrasound at Week 6, Week 12, and Week 18.|Neuromuscular ultrasound measures nerve compression (swelling) by cross sectional area of median nerve, in format % change from baseline.|Baseline to Week 18|||% change||Standard Deviation|Mean
649850|NCT02068443|Secondary|Fasting Blood Glucose|The value of the fasting plasma glucose collected at Baseline and Weeks 2, 4, 8, 12, 16, 20, 24 and EOT.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24 and EOT (Up to Week 24)|FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses.||mg/dL||Standard Deviation|Mean
649836|NCT02070302|Primary|Change From Baseline Levine Function Severity Scale Status at Weeks 6, 12,18.|Patients with Levine score of < 4 were included in the study. The score for this assessment can range from 8-40|Baseline-Week 18|Levine functional severity scale is a measure of mean of median value calculated for both Onabot and Placebo groups based on patient answered questions. This scale ranges from 1 (no symptoms) to 5 (severe symptoms). The function severity scale indicate interference of the symptoms on activities of daily living. Mean values reported for each group.||Scores on a scale||Standard Deviation|Mean
649837|NCT02070302|Primary|Change From Baseline Levine Symptom Severity Scale Status at Weeks 6, 12,18.|Patients with Levine score < 4 were included in the study. The score for this assessment can range from 11-55.|Baseline-Week 18|Levine symptom severity scale is a measure of mean of median value calculated for both Onabot and Placebo groups based on patient answered questions. It ranges from 1 (no symptoms) to 5 (severe symptoms). This scale indicate how severe the CTS symptoms feel to the patient. Mean values (std deviation) are reported both Onabot and Placebo groups.||Scores on a scale||Standard Deviation|Mean
649838|NCT02070237|Secondary|Supraprophylactic Range Anti Xa Level|We will assess if any of the subjects has an Anti Xa level that is in the supraprophylactic range (treatment range).|3.5-4 hours after the third dose of Lovenox (enoxaparin)|||participants|||Number
649839|NCT02070237|Primary|Anti Xa Level|Our primary outcome will be to assess the Anti Xa level drawn 3.5-4 hours after the third dose of Lovenox (enoxaparin) to assess if this is in the prophylactic range.|3.5-4 hours after the third dose of Lovenox (enoxaparin)|||IU/mL||95% Confidence Interval|Mean
649840|NCT02069093|Secondary|Blood Concentration of Everolimus and Exemestane|Blood samples were collected and analyzed.|28 days (pre-dose)|The PK analysis set, which was a subset of the FAS, was considered for the analysis. However, only participants who had evaluable data were analyzed.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
649841|NCT02069093|Secondary|Dose Intensity of Everolimus and Exemestane|The dose intensity was calculated as the cumulative dose of everolimus or exemestane divided by the length of time on treatment during the first 56 days of treatment.|56 days|FAS: The FAS consisted of all participants who received at least one dose of study treatment (everolimus and/or exemestane) and at least one dose of investigational treatment (dexamethasone mouth wash).||mg/day||Full Range|Median
649842|NCT02069093|Secondary|Number of Participants With All Grades of Stomatitis|The number of participants with all grades of stomatitis was defined as the number of participants who had stomatitis grade 1 or higher. Grade 1 = minimal symptoms, normal diet; grade 2 = symptomatic, but able to swallow a modified diet; grade 3 = symptomatic and unable to aliment or hydrate orally; and grade 4 = symptoms associated with life-threatening consequences.|56 days|The FAS, consisting of all participants who received at least one dose of study treatment (everolimus and/or exemestane) and at least one dose of investigational treatment (dexamethasone mouth wash), was considered for the analysis. However, only those participants, who were evaluable for stomatitis grade, were analyzed.||Participants|||Number
649843|NCT02069093|Secondary|Median Number of Mouthwashes Per Day|The median number of mouthwashes per day was assessed.|56 days|FAS: The FAS set consisted of all participants who received at least one dose of study treatment (everolimus and/or exemestane) and at least one dose of investigational treatment (dexamethasone mouth wash).||Number of mouthwashes||Full Range|Median
649844|NCT02069093|Secondary|Time to Resolution of Stomatitis From Grade 2 or Greater to Grade 1 or Less|The number of days to achieve resolution of stomatitis from grade 2 or greater to grade 1 or less was assessed. Grade 1 = minimal symptoms, normal diet; grade 2 = symptomatic, but able to swallow a modified diet; grade 3 = symptomatic and unable to aliment or hydrate orally; and grade 4 = symptoms associated with life-threatening consequences.|56 days|FAS: The FAS consisted of all participants who received at least one dose of study treatment (everolimus and/or exemestane) and at least one dose of investigational treatment (dexamethasone mouth wash).||Days||Full Range|Median
649845|NCT02069093|Primary|Number of Participants With Stomatitis Grade ≥ 2|The incidence of grade ≥ 2 stomatitis was reported. Grade 1 = minimal symptoms, normal diet; grade 2 = symptomatic, but able to swallow a modified diet; grade 3 = symptomatic and unable to aliment or hydrate orally; and grade 4 = symptoms associated with life-threatening consequences.|56 days|Full analysis set (FAS): The FAS consisted of all participants who received at least one dose of study treatment (everolimus and/or exemestane) and at least one dose of investigational treatment (dexamethasone mouth wash).||Participants|||Number
649846|NCT02068443|Secondary|Number of Participants Who Had Clinically Relevant Changes in 12-Lead Electrocardiogram (ECG) Findings|Number of participants who had ECG findings changed from “normal” or “abnormal but not clinically relevant” at Baseline to “abnormal and clinically relevant”.|Baseline and Weeks 12 and 24|"Safety Analysis Set, all participants who received at least 1 dose of study drug, with ECG values normal or abnormal not clinically significant at Baseline."||participants|||Number
649847|NCT02068443|Secondary|Percentage of Participants With TEAEs Related to Vital Signs|Vital signs included sitting systolic and diastolic blood pressures (mmHg) (measured after resting for ≥ 5 minutes) and pulse rate (beats per minute [bpm]).|24 Weeks|Safety Analysis Set included all participants who received at least 1 dose of study drug.||percentage of participants|||Number
649848|NCT02068443|Secondary|Percentage of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis|The percentage of participants with any clinically relevant safety laboratory changes (chemistry, hematology and urinalysis) collected throughout study and recorded as AEs.|24 Weeks|Safety Analysis Set included all participants who received at least 1 dose of study drug.||percentage of participants|||Number
649849|NCT02068443|Secondary|Percentage of Participants With Treatment-Emergent Adverse Events (TEAE)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|24 Weeks|Safety Analysis Set included all participants who received at least 1 dose of study drug.||percentage of participants|||Number
651341|NCT02030535|Secondary|RR Change From Patient Baseline at Individual Post-dose Time Points|RR change from patient baseline at individual post-dose time points|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)||ms||Standard Deviation|Mean
649851|NCT02068443|Secondary|Change From Baseline in Fasting Blood Glucose|The change in the value of the fasting plasma glucose collected at Weeks 2, 4, 8, 12, 16, 20 and 24 relative to Baseline. A negative change from Baseline indicates improvement.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24 and EOT (Up to Week 24)|FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses.||mg/dL||Standard Deviation|Mean
649852|NCT02068443|Secondary|Percentage of Participants Achieving Target HbA1c (NGSP) Levels at the EOT Period|HbA1c (NGSP) is the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound. The percentage of participants with HbA1c levels of ≥6.0, ≥7.0 and ≥8.0 at the end of Screening (Baseline) with change to target values <6.0, <7.0 and <8.0 respectively at EOT.|Baseline and EOT (Up to Week 24)|FAS included all randomized participants who received at least 1 dose of study drug.||percentage of participants|||Number
649853|NCT02068443|Secondary|HbA1c (NGSP)|The value of HbA1c (NGSP) (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, and EOT.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24 and EOT (Up to Week 24)|FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses.||percent||Standard Deviation|Mean
649854|NCT02068443|Secondary|Change From Baseline in HbA1c (NGSP)|The change in the value of HbA1c (NGSP) (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Weeks 2, 4, 8, 12, 16, 20, 24, and EOT relative to Baseline. A negative change from Baseline indicates improvement.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24 and EOT (Up to Week 24)|FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses.||percent||Standard Deviation|Mean
649855|NCT02068443|Primary|Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) National Glycohemoglobin Standardization Program (NGSP) at the End of Treatment (EOT) Period|The change in the value of HbA1c (NGSP) (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at End of Treatment Period relative to Baseline. A negative change from Baseline indicates improvement. An Analysis of Covariate (ANCOVA) model with change from Baseline as a dependent variable and Baseline and treatment as independent variables was used for main analyses.|Baseline and End of Treatment (EOT) (Up to Week 24)|Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study drug.||percent||Standard Error|Least Squares Mean
649856|NCT02068222|Secondary|The Percentage of Subjects With Post-Treatment Relapse|Percentage of subjects with confirmed quantifiable HCV RNA within 12 weeks of last dose among subjects with unquantifiable hepatitis C virus ribonucleic acid at the end of treatment.|Within 12 weeks after the last dose of study drug|||percentage of participants||95% Confidence Interval|Number
649857|NCT02068222|Secondary|The Percentage of Subjects With Virologic Failure During Treatment|Percentage of subjects with quantifiable HCV RNA throughout the entire treatment period, confirmed quantifiable HCV RNA after previously having unquantifiable HCV RNA, or a confirmed increase of at least one log10 in HCV RNA during treatment.|Up to Treatment Week 12|||percentage of participants||95% Confidence Interval|Number
649858|NCT02068222|Secondary|The Percentage of Subjects Who Achieve 24-week Sustained Virologic Response (SVR24)|SVR24 defined as HCV RNA LLOQ 24 weeks after last dose of study drug.|24 weeks after last dose of study drug|||percentage of participants||95% Confidence Interval|Number
649859|NCT02068222|Primary|The Percentage of Subjects Who Achieve 12-week Sustained Virologic Response (SVR12)|SVR12 defined as hepatitis C (HCV) ribonucleic acid (RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.|12 weeks after last dose of study drug|||percentage of participants||95% Confidence Interval|Number
649862|NCT02068027|Secondary|Mean Daily Worst Pain Intensity Numeric Pain Rating Scale Scores|The Numeric Pain Rating Scale is a single reading that measures the patients interpretation of their pain on a scale from 0, no pain to 10, worst pain imaginable. The change from baseline can range from -10 to 10. The change from Baseline (worst score from Day -14 to Day -8) to End-of-Treatment (worst score during Days 78 to 84 [±3 days]) in the Numeric Pain Rating Scale score assessing the “worst pain in the past 24 hours in the painful areas of the feet” from Days 78 to 84 compared to the 7 days at the Baseline Phase (Days -14 to -8). For the endpoint, the change in worst pain intensity from Baseline to Week 12 was analyzed using an analysis of covariance (ANCOVA) model with the Baseline worst pain intensity score serving as a covariate. The statistical model also included treatment, site, site by treatment interaction, and strata. If the site by treatment interaction term was not significant at the 0.1 level, then it was excluded from the model.|The change from Baseline (worse over Day -14 to Day -8) to End-of-Treatment (worse over Days 78 to 84 [±3 days])|||units on a scale||Standard Deviation|Mean
649863|NCT02068027|Primary|Change From Baseline to Day 84 (Week 12) in Numeric Pain Rating Scale Score|The Numeric Pain Rating Scale is a single reading that measures the patients interpretation of their pain on a scale from 0, no pain to 10, worst pain imaginable. The change from baseline can range from -10 to 10. The change from Baseline (averaged over Day -14 to Day -8) to End-of-Treatment (averaged over Days 78 to 84 [±3 days]) in the Numeric Pain Rating Scale score assessing the “average pain in the past 24 hours in the painful areas of the feet” averaged over Days 78 to 84 compared to the 7 days at the Baseline Phase (Days -14 to -8). For the primary efficacy endpoint, the mean change in pain intensity from Baseline to Week 12 was analyzed using an analysis of covariance (ANCOVA) model with the Baseline pain intensity score serving as a covariate. The statistical model also included treatment, site, site by treatment interaction, and strata. If the site by treatment interaction term was not significant at the 0.1 level, then it was excluded from the model.|The change from Baseline (averaged over Day -14 to Day -8) to End-of-Treatment (averaged over Days 78 to 84 [±3 days])|||units on a scale||Standard Deviation|Mean
649864|NCT02067728|Secondary|BMI Z-score Change for Ages 11-17 Years||Baseline and 6 months post encounter|||BMI z-score||Standard Deviation|Mean
649865|NCT02067728|Secondary|BMI Z-score Change for Ages 4-10 Years||Baseline and 6 months post encounter|||BMI z-score||Standard Deviation|Mean
649866|NCT02067728|Secondary|Success of Other Health Goals|Degree to which other health behavior goals (non-obesiogenic) were set and carried out at 6 months post encounter. Success defined as response of 2-4 on health behaviors survey, with 2=success some of the time, 3=success most of the time, and 4=success almost always.|6 months post encounter|This analysis population only includes subjects who set a health goal, which was not obesiogenic focused, during the initial visit and responded to the survey regarding success of achieving the goal 6 months post encounter.||percentage of participants|||Number
649867|NCT02067728|Secondary|Success of Other Health Goals|Degree to which other health behavior goals (non-obesiogenic) were set and carried out at 1 month post encounter. Success defined as response of 2-4 on health behaviors survey, with 2=success some of the time, 3=success most of the time, and 4=success almost always.|1 month post encounter|This analysis population only includes subjects who set a health goal, which was not obesiogenic focused, during the initial visit and responded to the survey regarding success of achieving the goal 1 month post encounter.||percentage of participants|||Number
649868|NCT02067728|Secondary|Success of Obesiogenic Goals|Degree to which an obesiogenic goal was set and successfully carried out at 6 months post encounter. Success is defined as rating of 3 or 4 on the 1 month health behavior survey, with 3=goal met most of the time and 4= goal met almost always.|6 months post encounter|This analysis population only includes those participants who initially set an obesiogenic focused goal at their well child check and then responded to the survey 6 months after to rate their success level in achieving that goal.||percentage of participants|||Number
649869|NCT02067728|Secondary|Success of Obesiogenic Goals|Degree to which an obesiogenic goal was set and successfully carried out at 1 month post encounter. Success is defined as rating of 3 or 4 on the 1 month health behavior survey, with 3=goal met most of the time and 4= goal met almost always.|1 month post encounter|This analysis population only includes the subjects who had initially set an obesiogenic goal at the well child appointment and responded to the survey at 1 month after the medical encounter to rate their level of success in achieving that goal.||percentage of participants|||Number
649870|NCT02067728|Secondary|Obesiogenic Goal Setting Success|Degree to which an obesiogenic goal was set and carried out at 6 months after the encounter. Success defined as response of 2-4 on survey, with 2=success some of the time, 3=success most of the time, and 4=success almost always.|6 months after encounter|This analysis population only includes the subjects who had initially set an obesiogenic goal at the well child appointment and responded to the survey at 6 months after the medical encounter when goal was set.||percentage of participants|||Number
649871|NCT02067728|Other Pre-specified|Obesity Follow-up Adherence|Subjects identified as obese with recommended follow-up appointment who are adherent to recommendation within 6 months of encounter|6 months after the encounter|This analysis population only includes the subjects who were identified as obese at their initial appointment and had a 6 month follow up appointment scheduled at that time.||percentage of participants|||Number
649872|NCT02067728|Other Pre-specified|Perception of Patient Centeredness of Encounter|Patient centeredness survey which measures the parent's and patient's (if 12 years and older) perception of how patient centered the communication was with the provider. Survey Coding for Patient Centeredness: 1=Not at all; 2=A little; 2.5=Can't say; 3=Somewhat; 4=A lot|1 month after the encounter|||units on a scale||Standard Deviation|Mean
649873|NCT02067728|Other Pre-specified|BMI Z-score Change for All|Anthropometric measures of weight and height and calculated BMI z score change at 6 months post encounter.|Baseline and 6 months after the encounter|The number of participants analyzed is low because returning for measurement checks was optional at 6 months & only 28% usual care and 27% intervention group attended. We also included chart abstraction measurements for those who had a return clinic visit with measurements within 6 months +/- 2 months from initial encounter.||BMI z-score||Standard Deviation|Mean
649874|NCT02067728|Secondary|Obesiogenic Goal Setting Success|Degree to which an obesiogenic goal was set and carried out at 1 month after the encounter. Success defined as response of 2-4 on health behaviors survey, with 2=success some of the time, 3=success most of the time, and 4=success almost always.|1 month after the encounter|This analysis population only includes the participants who set an obesiogenic goal at the initial appointment and completed the 1 month post survey to rate their success level in achieving that goal.||percentage of participants|||Number
649875|NCT02067728|Primary|Percentage of Patients With Documented Goal Setting|Health behavior change goal documented in charting of well-child visits.|2 weeks from encounter|Manual chart review of the electronic medical record (EMR) was completed by the Research Team for all enrolled subjects in both study groups. Goal documentation was defined as any type of goal consisting of an active verb written either on the FNPA Tool which was completed during the well child visit or in Physician notes in the EMR for the visit.||percentage of participant charts|||Number
649876|NCT02067585|Secondary|Glucose||6 hours|||mmol/L||Standard Deviation|Mean
649877|NCT02067585|Secondary|Glucose||4 hours|||mmol/L||Standard Deviation|Mean
649878|NCT02067585|Secondary|Glucose||90 minutes|||mmol/L||Standard Deviation|Mean
649879|NCT02067585|Secondary|Glucose||30 minutes|||mmol/L||Standard Deviation|Mean
649880|NCT02067585|Secondary|Blood Glucose||0 minute|||mmol/L||Standard Deviation|Mean
649881|NCT02067585|Primary|Triglyceride||6 hours|||mmol/L||Standard Deviation|Mean
649882|NCT02067585|Primary|Triglyceride||4 hours|||mmol/L||Standard Deviation|Mean
649883|NCT02067585|Primary|Triglyceride||90 minutes|||mmol/L||Standard Deviation|Mean
649884|NCT02067585|Primary|Triglycerides||30 minutes|||mmol/L||Standard Deviation|Mean
649885|NCT02067585|Primary|Triglycerides Post-prandial||0 minutes|||mmol/L||Standard Deviation|Mean
649886|NCT02067533|Primary|Knee Range of Motion (ROM)|in all patients ROM is measure 1 year after knee surgery by one of the study investigator using goniometer.|1 year after total knee arthroplasty|||degree||Standard Deviation|Mean
649887|NCT02067273|Primary|Present Pain Intensity|Present pain intensity was reported by participants using a visual analog scale (VAS) from scores ranging from 1-10; lower scores represent less pain, higher scores represent more severe pain.|Baseline, post-treatment, one week follow-up|Data from participants who completed the study were analyzed.||Units on a scale||Standard Deviation|Mean
650036|NCT02062879|Secondary|Median Pain Score|Median daily pain score measures on a visual analogue scale for pain, with a range of 0 to 10. Higher scored indicate worse pain.|Participants will be followed for their entire hospital stay, an expected average of 1 week|||scores on a scale||Inter-Quartile Range|Median
649888|NCT02066922|Secondary|Number of Eyes With Change of >1.00 Diopter (D) in Spherical Equivalent of Subjective Refraction From Baseline at Week 1|Subjective manifest refraction was assessed using a phoropter or trial frame set with the subject’s current prescription at Baseline (Visit 2) after a 2-day washout period and approximately 15 minutes after study lens removal following 8 hours of wear (Week 1). Spectacle over-refraction, if required, was performed. Higher myopia is indicated by larger negative values in manifest refraction.|Baseline, Week 1 (Day 8 of lens wear)|This analysis group includes all randomized participants with data present at visit.||Eyes|||Number
649889|NCT02066922|Primary|Change in Average Central Corneal Curvature From Dispense at Week 1|Corneal curvature (horizontal and vertical keratometry values on the same eye) was measured using a calibrated keratometer prior to study lens dispense (Day 1) and approximately 15 minutes after study lens removal following 8 hours of wear (Week 1). Minus values in change-from-baseline indicate corneal flattening.|Dispense (Day 1 of lens wear), Week 1 (Day 8 of lens wear)|This analysis group includes all randomized participants with data present at visit.||diopters||Standard Deviation|Mean
649890|NCT02066896|Secondary|Salivary Flux Measurement|"The salivary flux was measured at the same time, without previous meal or tooth brushing, drinking or eating, in a quiet room. Spilled saliva was collected in a graduated Falcon 15ml tube. The samples of saliva were frozen and stored at -20° C.
Normal salivary stimulated flux is above 0,5 ml/min. Normal unstimulated salivary flux is above 0,2 ml/min."|6 weeks|||ml/min||Standard Deviation|Median
649891|NCT02066896|Secondary|Salivary Biomarker Analysis. Beta 2 Microglobulin.|"The saliva in Sögren`s syndrome patients has a high level of beta 2 microglobulin reflecting progression of the disease and inflammatory process at glandular epithelium.
The saliva samples were collected at the baseline and end point. Beta 2 microglobulin was determined by Elisa human kit (ABCAM ab 108885).
The normal levels are 1,2 +/- 0,7 microg/ml, and for primary Sjögren`s syndrome 5,3 +/- 4,6 microg/ml.
This measure was done in the samples of saliva before and after the lasertherapy for all patients."|6 weeks|||microg/ml||Standard Deviation|Median
649892|NCT02066896|Primary|The Xerostomia Inventory|"The Xerostomia Inventory (XI) is an 11-item questionnaire (Thomson et al, 1999). Scores to the 11 items are summated, providing a single score (5-55) representing the subjective severity of xerostomia. In 2012, da Mata published a validated version in portuguese and we used this version. The better score is the lowest. The significant variation is defined as 6 or more.
Bellow we describe all the 11 questions:
I sip liquids to aid in swallowing food
My mouth feels dry when eating a meal
I get up at night to drink
My mouth feels dry
I have difficulty in eating dry foods
I suck sweets or cough lollies to relieve dry mouth
I have difficulties swallowing certain foods
The skin of my face feels dry
My eyes feel dry
My lips feel dry
The inside of my nose feels dry __________________________________________________________
Score:
Never’ (1), Hardly ever’ (2), Occasionally’ (3), Fairly often’ (4), Very often’ (5)"|6 weeks|Intent to treat population. Last observation carried forward imputation method.||units on a scale||Standard Deviation|Mean
649893|NCT02066857|Secondary|Change in SF-12 QOL|The SF-12 QOL is a self-administered measure asking views about participant's health and how well they are able to perform usual activities.|Baseline, Month 3|No participants completed this survey as this outcome measure was removed from the protocol. No data were collected.|||||
649894|NCT02066857|Secondary|Mean Disabilities of the Arm and Shoulder (DASH) Questionnaire Score|The DASH questionnaire asks about symptoms as well as ability to perform certain activities. Scores range on a 0-100 scale. A higher score indicates greater disability.|Baseline, Week 2, Week 6, Week 12|Of the 5 participants who were enrolled, data were analyzed for the 3 participants who completed all study visits.||units on a scale||Standard Deviation|Mean
649895|NCT02066857|Primary|Mean Pain Score|"Pain will be assessed by a visual analog scale (VAS). Participants rate their pain level in a scale from 0 to 10; 0 representing no pain and 10 representing the worst pain imaginable. The assessment was completed at all study visits."|Baseline, Week 2, Week 6, Week 12|Of the 5 participants who were enrolled, data were analyzed for the 3 participants who completed all study visits.||units on a scale||Standard Deviation|Mean
649896|NCT02066857|Primary|Complication Rate|The number of participants who experienced treatment related complications including the need for manipulation in the case of lost reduction.|Duration of Study (Up to 3 Months)|Of the 5 participants who were enrolled, data were analyzed for the 3 participants who completed all study visits.||Participants|||Count of Participants
649897|NCT02066857|Primary|Change in Grip Strength|Grip strength will be assessed by bilateral dynamometer testing.|Baseline, Month 3|Data for this outcome measure are not available for analysis.|||||
649898|NCT02066857|Primary|Mean Mayo Wrist Score|The Mayo Wrist Score is a clinician-completed scoring system used to evaluate the level of functionality in the wrist, assessing pain, functional status (able to work), range of motion and grip strength. Total scores for functionality range from 0-100 and are categorized as follows: 90-100 indicates excellent, 80-90 indicates good, 60-80 indicates satisfactory, below 60 indicates poor. The assessment was completed at all study visits.|Baseline, Week 2, Week 6, Week 12|Of the 5 participants who were enrolled, data were analyzed for the 3 participants who completed all study visits.||units on a scale||Standard Deviation|Mean
649899|NCT02066857|Primary|Change in Wrist Range of Motion (ROM)|Wrist ROM will be assessed by a goniometer exam.|Baseline, Month 3|Data for this outcome measure are not available for analysis.|||||
649900|NCT02066740|Primary|Successful Stent Deployment|Successful stent deployment to be assessed based on stent delivery, lesion coverage and accuracy of deployment.|Procedure|||percentage - successful stent deployment|Participants||Number
649901|NCT02066740|Primary|Absence of Stent Elongation|Absence of stent elongation is achieved when the implanted stent length does not exceed the allowed stent length|Intra operative|||percentage absence of stent elongation|Participants||Number
649902|NCT02066727|Secondary|Complication Related With Nerve Block|Complication related with nerve block is defined as the presence of either bradycardia, delayed recovery, persistent groin pain, neuropathy during operation and postoperatively|during operation, 0.5,24hour postoperatively||||||
649915|NCT02066233|Secondary|Preference for Either of the Two Procedures, EG II Scan Versus Standard Endoscopy|"Subjects were asked the following question: Based on the overall experience (including need for sedation, ability to drive, time off work, procedure comfort, procedure time, etc.). Which procedure would you prefer to have in the future? Possible answers were: Nasal camera test (EG), oral camera test (Gastroscopy), or either test."|Two weeks|Two subjects on the reflux and/or heartburn arm didn't answer this question.||Participants|||Count of Participants
649903|NCT02066727|Primary|Median Effective Concentration(EC50)|"Median effective concentration(EC50) was not calculated per-participants, the up-and-down sequential allocation method was used to determine the median effective concentration(EC50) of lidocaine, running the two groups in parallel. The concentration of lidocaine for the second and subsequent patients in each group were dictated by the response of the previous patient in the group, such that an effective block led to a decreased concentration of the next patient, an ineffective block led to an increased concentration.
For each group, we collected: the logarithm of lidocaine concentration, the number of effective block, ineffective block, total number of the patient, and successful rate. Then lgEC50 and slgEC50 was calculated as formulas. The logarithm of confidence intervals(95% CI) was calculated as lgEC50±1.96slgEC50. All of the calculation can be performed by SPSS19.0 for windows."|10min|||mg/ml(the concentration of lidocaine)||95% Confidence Interval|Number
649904|NCT02066402|Secondary|Change From Baseline in the Faces Rating Scale (FRS) Pain Scores at Each Time Point|The patient-reported level of pain were assessed by the faces rating scale (FRS) pain score. The patient-reported level of pain were assessed by the faces rating scale (FRS) pain score. Ask the patient to rate their pain from 0 to 10 with 0 being no pain at all and 10 being the worst pain then enter the numerical value.|Up to EOT visit (Day 11)|ITT||Units on a scale||Standard Deviation|Mean
649905|NCT02066402|Secondary|Value of the Faces Rating Scale (FRS) Pain Scores at Each Time Point|The patient-reported level of pain were assessed by the faces rating scale (FRS) pain score. Ask the patient to rate their pain from 0 to 10 with 0 being no pain at all and 10 being the worst pain then enter the numerical value.|Up to EOT visit (Day 11)|ITT||Units on a scale||Standard Deviation|Mean
649906|NCT02066402|Secondary|Change From Baseline in the Visual Analog Scale (VAS) Pain Scores at Each Time Point|The patient-reported level of pain were assessed by the visual analog scale (VAS) pain score. VAS pain score ranged from 0 mm (no pain) to 100 mm (worst pain ever). It used a 100 mm VAS to instruct the patient to indicate the point along the line that represents the pain they are feeling. Once the patient indicates how much pain they are feeling, measure the distance from no pain and enter the value.|Up to EOT visit (Day 11)|ITT||Units on a scale||Standard Deviation|Mean
649907|NCT02066402|Secondary|Value of the Visual Analog Scale (VAS) Pain Scores at Each Time Point|The patient-reported level of pain were assessed by the visual analog scale (VAS) pain score. VAS pain score ranged from 0 mm (no pain) to 100 mm (worst pain ever). It used a 100 mm VAS to instruct the patient to indicate the point along the line that represents the pain they are feeling. Once the patient indicates how much pain they are feeling, measure the distance from no pain and enter the value.|Up to EOT visit (Day 11)|ITT||Units on a scale||Standard Deviation|Mean
649908|NCT02066402|Secondary|Investigator’s Assessment of Clinical Response at Day 7 Visit|The Investigator made an assessment of clinical response at Day 7 Visit based on following definition: Improving (Improvement in overall clinical status of ABSSSI compatible with continuation of study drug therapy); Other.|Baseline and Day 7 visit|ITT||Percentage of participants|||Number
649909|NCT02066402|Secondary|Investigator’s Assessment of Clinical Response at 48-72 Hours|The Investigator made an assessment of clinical response at the 48-72 Hour Visit based on following definition: Improving (Improvement in overall clinical status of ABSSSI compatible with continuation of study drug therapy); Stable (Signs and symptoms stable, no apparent change in overall clinical status but compatible with continuation of study drug therapy); Other.|Baseline and at 48-72 hours|ITT||Percentage of participants|||Number
649910|NCT02066402|Secondary|Overall Investigator’s Assessment of Clinical Success at Post Therapy Evaluation (PTE) Visit (7-14 Days After EOT Visit) in the Clinically Evaluable at Post Therapy Evaluation (CE-PTE) Analysis Set|The Investigator made an assessment of clinical response at the PTE Visit (7-14 days after the EOT Visit +2 days). Participants assessed as a clinical failure at the EOT Visit are considered a clinical failure at the PTE Visit. Percentage of participants with clinical success, clinical failure or indeterminate were reported.|Baseline and post-therapy evaluation visit (7-14 days after Day 11)|CE-PTE||Percentage of participants|||Number
649911|NCT02066402|Secondary|Overall Investigator’s Assessment of Clinical Success at Post Therapy Evaluation (PTE) Visit (7-14 Days After EOT Visit) in the ITT Analysis Set|The Investigator made an assessment of clinical response at the PTE Visit (7-14 days after the EOT Visit +2 days). Participants assessed as a clinical failure at the EOT Visit are considered a clinical failure at the PTE Visit. Percentage of participants with clinical success, clinical failure or indeterminate were reported.|Baseline and post-therapy evaluation visit (7-14 days after Day 11)|ITT||Percentage of participants|||Number
649912|NCT02066402|Secondary|Programmatically Defined Clinical Response at End of Therapy (EOT) Visit in the Clinically Evaluable at EOT (CE-EOT) Analysis Set|Clinical response will be defined as percentage of participants with clinical success, clinical failure or indeterminate.|Baseline and EOT visit (Day 11)|CE-EOT||Percentage of participants|||Number
649913|NCT02066402|Secondary|Programmatically Defined Clinical Response at End of Therapy (EOT) Visit in the ITT Analysis Set|Clinical Failure: Presence of fever; No lesion size decrease from baseline; Clinician assessment of tenderness worse than mild; Persistent same or great intensity purulent drainage of wound infection; Confounding use of systemic concomitant antibiotic; TEAE lead to study drug discontinuation; Require additional antibiotic treatment for primary lesion; Unplanned major surgical intervention. Clinical Success: Afebrile or fever due to other cause; Lesion size decrease from baseline; Clinician assessment of mild/absent tenderness; None/lesser intensity purulent drainage of wound infection; None confounding use of systemic concomitant antibiotic; None TEAE leading to study drug discontinuation; No additional antibiotic therapy for primary lesion; No unplanned major surgical intervention; No osteomyelitis after baseline; For wound/abscess: no incision/drainage of the ABSSSI site after Day1 unless planned. For cellulitis/ersipelas: no incision/drainage of the ABSSSI site after 48‑72 H Visit.|Baseline and EOT visit (Day 11)|ITT||Percentage of participants|||Number
649914|NCT02066402|Primary|Percentage of Participants With Early Clinical Response at 48-72 Hours After the First Infusion of Study Drug in the ITT Analysis Set.|Early clinical response is defined as responder if there is >=20% reduction in the area of erythema, edema, and/or induration (length × width) of the primary acute bacterial skin and skin structure infections (ABSSSI) lesion, compared with baseline at the 48-72 Hour visit.|Baseline and 48-72 hours visit|ITT||Percentage of participants|||Number
649916|NCT02066233|Primary|Median Tolerability Score on 10-point Visual Analog Scale (VAS)|"On the 10-point VAS, 0 represented the worst experience and 10 the best experience."|Within 48 hours|||units on a scale||Full Range|Median
649918|NCT02066051|Primary|Number of Participants Who Responded to Intense Pulsed Light (IPL)|Participants received treatment over 4 months and were monitored for safety and response for an additional 8 months. The symptoms were scored with the Standard Patient Evaluation of Eye Dryness (SPEED2) questionnaire. The SPEED questionnaire presents the four most commonly experienced dry eye symptom groups and asks patients to tick a box for all symptoms that apply to them. The frequency section ratings run from 0 (never) to 3 (constant), and the severity section ratings run from 0 (no problems) to 4 (intolerable), for a total score ranging from 0 (no problem) to 28 (severe problems). Over a 30% improvement in the SPEED2 score equated a response. None of the subjects were expected to get a complete response due to the nature of the damage to their ocular surface from GVHD.|12 months|||participants|||Number
649919|NCT02065453|Primary|The Primary Endpoint of This Study is Time Difference Between Cauterizing One Side of the Uterine Attachments, From the Round Ligament to the Uterine Artery on One Side, to the Time Detaching the Same Tissues on the Other Side|duration of surgery|Primary outcome study data is collected with the first incision and completed with skin closure at the completion of the surgery.|Uterine Vessel Desiccation and Electrosurgical Cutting Time (min)||minutes||Full Range|Median
649920|NCT02064985|Secondary|Pharmacokinetics Parameters of Metabolite : Parent on Day 7---AUC(0-12h)|To determine AUC(0-12h) ratio of metabolite to that of the parent compound on Day 7.|Day 7|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.||ratio||Standard Deviation|Mean
649921|NCT02064985|Secondary|Pharmacokinetics Parameters of Metabolite : Parent on Day 1--AUC(0-inf)|To determine AUC(0-inf) ratio for the metabolite to that of the parent compound on Day 1|Day 1|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.||ratio||Standard Deviation|Mean
649922|NCT02064985|Secondary|Safety---Clinical Chemistry Variables Over Time---Bicarbonate|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Clinical Chemistry---Bicarbonate"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.||mmol/L||Standard Deviation|Mean
649923|NCT02064985|Secondary|Safety---Clinical Chemistry Variables Over Time---Blood Urea Nitrogen|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Clinical Chemistry---Blood Urea Nitrogen"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.||mmol/L||Standard Deviation|Mean
649924|NCT02064985|Secondary|Safety---Clinical Chemistry Variables Over Time---Protein|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Clinical Chemistry---Protein"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.||g/L||Standard Deviation|Mean
649925|NCT02064985|Secondary|Safety---Clinical Chemistry Variables Over Time---Albumin|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Clinical Chemistry---Albumin"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.||g/L||Standard Deviation|Mean
649926|NCT02064985|Secondary|Safety---Clinical Chemistry Variables Over Time---Phosphate|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Clinical Chemistry---Phosphate"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.||mmol/L||Standard Deviation|Mean
649927|NCT02064985|Secondary|Safety---Clinical Chemistry Variables Over Time---Chloride|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Clinical Chemistry---Chloride"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.||mmol/L||Standard Deviation|Mean
649928|NCT02064985|Secondary|Safety---Clinical Chemistry Variables Over Time---Potassium|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Clinical Chemistry---Potassium"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.||mmol/L||Standard Deviation|Mean
649929|NCT02064985|Secondary|Safety---Clinical Chemistry Variables Over Time---Sodium|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Clinical Chemistry---Sodium"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.||mmol/L||Standard Deviation|Mean
649930|NCT02064985|Secondary|Safety---Clinical Chemistry Variables Over Time---Total Bilirubin|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Clinical Chemistry---Total Bilirubin"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.||umol/L||Standard Deviation|Mean
649931|NCT02064985|Secondary|Safety---Clinical Chemistry Variables Over Time---Creatinine|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Clinical Chemistry---Creatinine"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.||umol/L||Standard Deviation|Mean
653969|NCT01972776|Primary|Percentage of Participants With Adverse Events (Part 1)|Adverse events were counted and corresponding percentages were tabulated.|14 days|All randomized part 1 participants||percentage of participants|||Number
649932|NCT02064985|Secondary|Safety---Clinical Chemistry Variables Over Time---Alkaline Phosphatase|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Clinical Chemistry---Alkaline Phosphatase"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.||ukat/L||Standard Deviation|Mean
649933|NCT02064985|Secondary|Safety---Clinical Chemistry Variables Over Time---Aspartate Aminotransferase|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Clinical Chemistry---Aspartate Aminotransferase"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.||ukat/L||Standard Deviation|Mean
649934|NCT02064985|Secondary|Safety---Clinical Chemistry Variables Over Time---Alanine Aminotransferase|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Clinical Chemistry---Alanine Aminotransferase"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.||ukat/L||Standard Deviation|Mean
649935|NCT02064985|Secondary|Safety---Clinical Chemistry Variables Over Time---Glucose|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Clinical Chemistry---Glucose"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.||mmol/L||Standard Deviation|Mean
649936|NCT02064985|Secondary|Safety---Hematology Laboratory Variables Over Time---Platelets|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Haematology---Platelets"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.||10^9/L||Standard Deviation|Mean
649937|NCT02064985|Secondary|Safety---Hematology Laboratory Variables Over Time---Leukocytes|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Haematology---Leukocytes"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.||10^9/L||Standard Deviation|Mean
649938|NCT02064985|Secondary|Safety---Hematology Laboratory Variables Over Time---Hemoglobin|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Haematology---Hemoglobin"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.||g/L||Standard Deviation|Mean
649939|NCT02064985|Secondary|Safety---Hematology Laboratory Variables Over Time---Erythrocytes|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Haematology---Erythrocytes"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.||10^12/L||Standard Deviation|Mean
649940|NCT02064985|Secondary|Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 7(3)|Pharmacokinetics parameters of Metabolite (AR-C124910XX) on Day 7---Accumulation ratio(ratio of Day 7 AUC(0-12h) to Day 1 AUC(0-12h))|Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.||ratio||Geometric Coefficient of Variation|Geometric Mean
649941|NCT02064985|Secondary|Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 7(2)|Pharmacokinetics parameters of Metabolite (AR-C124910XX) on Day 7---AUC(0-12h)|Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
649942|NCT02064985|Secondary|Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 1(2)|Pharmacokinetics parameters of AR-C124910XX (active metabolite) on Day 1---AUC(0-12h), AUC(0-t) and AUC(0-inf)|Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
649943|NCT02064985|Secondary|Safety---Vital Signs Over Time---Pulse Rate|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Vital signs (Pulse Rate)"|Baseline, Day 1 to Day 7 and 2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.||BEATS/MIN||Standard Deviation|Mean
649944|NCT02064985|Secondary|Safety---Vital Signs Over Time---Weight|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Vital signs (Weight)"|Baseline|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.||kg||Standard Deviation|Mean
649945|NCT02064985|Secondary|Safety---Vital Signs Over Time---Height|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Vital signs (Height)"|Baseline|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.||cm||Standard Deviation|Mean
650037|NCT02062879|Secondary|Breakthrough Daily Opioid Requirement|Breakthrough daily opioid requirement in milligrams of morphine equivalents/day|Participants will be followed for their entire hospital stay, an expected average of 1 week|||mg morphine equivalents/day||Inter-Quartile Range|Median
649946|NCT02064985|Secondary|Pharmacokinetics Parameters of Ticagrelor on Day 7(4)|Pharmacokinetics parameters of Ticagrelor on Day 7---Accumulation ratio(ratio of Day 7 AUC(0-12h) to Day 1 AUC(0-12h))|Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.||ratio||Geometric Coefficient of Variation|Geometric Mean
649947|NCT02064985|Secondary|Pharmacokinetics Parameters of Ticagrelor on Day 7(3)|Pharmacokinetics parameters of Ticagrelor on Day 7---AUC(0-12h)|Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
649948|NCT02064985|Secondary|Pharmacokinetics Parameters of Ticagrelor on Day 1(1)|The pharmacokinetics parameters of Ticagrelor on Day 1---Cmax|Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
649949|NCT02064985|Secondary|Safety---Causally Related Adverse Events by System Organ Class and Preferred Term|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Assessment of adverse events"|Includes adverse events with an onset date on or after the date of first dose and up to and including the last study visit (up to 2-5 days after last dose).|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.||Participants|||Number
649950|NCT02064985|Secondary|Safety---All Allowed Concomitant Medications During Study Treatment|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Concomitant medications"|All allowed concomitant medications during study treatment(up to 2-5 days after last dose), includes medications that began prior to randomization but were ongoing after randomization.|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.||Participants|||Number
649951|NCT02064985|Secondary|Safety---Hematology Laboratory Variables Over Time---hematocrit|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Haematology---hematocrit"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.||ratio||Standard Deviation|Mean
649952|NCT02064985|Secondary|Safety---Physical Examination, Summary of Abnormalities|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Physical examination"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.||Participants|||Number
649953|NCT02064985|Secondary|Pharmacokinetics Parameters of Metabolite : Parent on Day 7---Cmax|To determine Cmax ratio of metabolite to that of the parent compound on Day 7|Day 7|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.||ratio||Standard Deviation|Mean
649954|NCT02064985|Secondary|Pharmacokinetics Parameters of Metabolite : Parent on Day 1--Cmax|To determine Cmax ratio for the metabolite to that of the parent compound on Day 1|Day 1|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.||ratio||Standard Deviation|Mean
649955|NCT02064985|Secondary|Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 7(4)|Pharmacokinetics parameters of AR-C124910XX (active metabolite) on Day 7---tmax|Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.||hour||Full Range|Median
649956|NCT02064985|Secondary|Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 7(1)|Pharmacokinetics parameters of Metabolite (AR-C124910XX) on Day 7---Cmax|Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
649957|NCT02064985|Secondary|Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 1(3)|Pharmacokinetics parameters of AR-C124910XX (active metabolite) on Day 1: tmax and t1/2|Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.||hour||Full Range|Median
649958|NCT02064985|Secondary|Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 1(1)|Pharmacokinetics parameters of AR-C124910XX (active metabolite) on Day 1---Cmax|Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
653970|NCT01972659|Secondary|Postoperative Morphine Consumption||after 12 hour surgery||||||
653971|NCT01972659|Secondary|Rocuronium Supplementation||during surgery||||||
649959|NCT02064985|Secondary|Pharmacokinetics Parameters of Ticagrelor on Day 7(2)|The pharmacokinetics parameters of ticagrelor on Day 7---tmax|Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.||hour||Full Range|Median
649960|NCT02064985|Secondary|Pharmacokinetics Parameters of Ticagrelor on Day 1(2)|The pharmacokinetics parameters of Ticagrelor on Day 1---AUC(0-inf), AUC(0-12h) and AUC(0-t).|Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
649961|NCT02064985|Secondary|Pharmacokinetics Parameters of Ticagrelor on Day 1(3)|The pharmacokinetics parameter of ticagrelor on Day 1---tmax and t1/2|Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.||hour||Full Range|Median
649962|NCT02064985|Secondary|AUEC(Final Extent) on Day 7|The area-under-the-effect curve (AUEC) was estimated for ADP-induced final extent IPA.|IPA was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7|All randomly assigned patients who received at least 1 dose of ticagrelor with post-dose PD measurements available and no protocol deviation considered to significantly affect the integrity of PD results (eg, non-compliance with study drug).||%*h||Standard Deviation|Mean
649963|NCT02064985|Secondary|AUEC(Final Extent) on Day 1|The area-under-the-effect curve (AUEC) was estimated for ADP-induced final extent IPA.|IPA was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1|All randomly assigned patients who received at least 1 dose of ticagrelor with post-dose PD measurements available and no protocol deviation considered to significantly affect the integrity of PD results (eg, non-compliance with study drug).||%*h||Standard Deviation|Mean
649964|NCT02064985|Secondary|TIPA(Max)---Day 7|The time to peak IPA (TIPAmax) was estimated for ADP-induced final extent IPA.|Day 7|All randomly assigned patients who received at least 1 dose of ticagrelor with post-dose PD measurements available and no protocol deviation considered to significantly affect the integrity of PD results (eg, non-compliance with study drug).||hour||Inter-Quartile Range|Median
649965|NCT02064985|Secondary|TIPA(Max)---Day 1|The time to peak IPA (TIPAmax) was estimated for ADP-induced final extent IPA.|Day 1|All randomly assigned patients who received at least 1 dose of ticagrelor with post-dose PD measurements available and no protocol deviation considered to significantly affect the integrity of PD results (eg, non-compliance with study drug).||hour||Inter-Quartile Range|Median
649966|NCT02064985|Secondary|Percent Change From Baseline in PRU on Day 7|Percent Change from baseline in Platelet P2Y12 Reaction Units (PRU)(measured by VerifyNow) profiles of multiple doses of ticagrelor 45, 60, and 90 mg in Chinese patients with stable coronary heart disease on chronic low dose ASA.|Baseline and at 0 hour, 0.5 hour, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours after dose intake on Day 7|All randomly assigned patients who received at least 1 dose of ticagrelor with post-dose PD measurements available and no protocol deviation considered to significantly affect the integrity of PD results (eg, non-compliance with study drug).||% change from baseline||Standard Deviation|Mean
649967|NCT02064985|Primary|IPA on Day 7|"The inhibition of Platelet Aggregation (IPA) profiles of single and multiple doses of ticagrelor 45, 60, and 90 mg in Chinese patients with stable coronary heart disease (CHD) on chronic low dose ASA (75-100mg daily).
Primary variable: IPA (final extent) induced by 20µM ADP at each assessment point after single and multiple doses of ticagrelor measured by Light-Transmittance Aggregometry (LTA)."|Baseline and at 0 hour, 0.5 hour, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours after dose intake on Day 7|All randomly assigned patients who received at least 1 dose of ticagrelor with post-dose PD measurements available and no protocol deviation considered to significantly affect the integrity of PD results (eg, non-compliance with study drug).||% IPA||Standard Deviation|Mean
649968|NCT02064985|Secondary|Safety---Vital Signs Over Time---Blood Pressure|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Vital signs (seated blood pressure [BP])"|Baseline, Day 1 to Day 7 and 2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.||mmHg||Standard Deviation|Mean
649969|NCT02064985|Secondary|Pharmacokinetics Parameters of Ticagrelor on Day 7(1)|Pharmacokinetics parameters of Ticagrelor on Day 7---Cmax|Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
649970|NCT02064985|Secondary|Percent Change From Baseline in PRU on Day 1|Percent Change from baseline in Platelet P2Y12 Reaction Units (PRU)(measured by VerifyNow) profiles of multiple doses of ticagrelor 45, 60, and 90 mg in Chinese patients with stable coronary heart disease on chronic low dose ASA.|Baseline and at 0.5 hour, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours, 36 hours,48 hours after dose intake on Day 1|All randomized patients who received at least one dose of investigational product with post-dose PD measurements available and no protocol deviation considered to significantly affect the integrity of PD results (e.g., non-compliance with study drug) will be included in the PD analysis set.||% change from baseline||Standard Deviation|Mean
649984|NCT02064205|Secondary|The Appetite Suppressive Effect of Polydextrose During Meal Consumption (Satiation) and Satiety (After Food Consumption)|The appetite suppressive effect of polydextrose measured with Visual Analogue rating Scales (VAS). The AUCs were calculated for the scores obtained before - first score after meal intake (satiation) and for score after meal till start of next meal (in between meals, satiety). The VAS scores ranged from 0-100 for hunger and fullness (HUNGER: 0 = no hunger , 100 = very hungry; FULNESS: 0 = not full, 100 = very full)|one day|||mm*min||Standard Deviation|Mean
653972|NCT01972659|Secondary|Rocuronium Onset Time||during the surgery||||||
649971|NCT02064985|Primary|IPA on Day 1|"The Inhibition of Platelet Aggregation (IPA) profiles of single and multiple doses of ticagrelor 45, 60, and 90 mg in Chinese patients with stable coronary heart disease (CHD) on chronic low dose ASA (75-100mg daily).
Primary variable: IPA (final extent) induced by 20µM ADP at each assessment point after single and multiple doses of ticagrelor measured by Light-Transmittance Aggregometry (LTA)."|Baseline and at 0.5 hour, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours, 36 hours,48 hours after dose intake on Day 1|All randomly assigned patients who received at least 1 dose of ticagrelor with post-dose PD measurements available and no protocol deviation considered to significantly affect the integrity of PD results (eg, non-compliance with study drug).||% IPA||Standard Deviation|Mean
649972|NCT02064920|Secondary|Percentage of Correct Responses in the OCL Task Over 12 Weeks of Treatment|OCL is one of the Cogstate battery of tests, and is a continuous visual recognition task that assesses visual recognition, memory and attention using a pattern separation algorithm. The percentage of correct responses to 80 OCL questions is defined as the number of correct responses x 100 divided by the number of total responses; and ranges from 0 to 100, where 100 is best, and 0 is the worst outcome.|Weeks 4, 8, 12 and 16|All participants who received study medication and yielded at least one measurement for that endpoint.||Percentage of Corrrect Responses||Standard Deviation|Mean
649973|NCT02064920|Primary|One-card Learning (OCL) Measurement Over 12 Weeks of Treatment|OCL is one of the Cogstate battery of tests, and is a continuous visual recognition task that assesses visual recognition, memory and attention using a pattern separation algorithm. OCL is a score defined as the arcsine transformation of the square root of the proportion of correct responses to 80 OCL questions. The score ranges from 0 to 1.5708 where a higher score means better performance.|Weeks 4, 8, 12 and 16|All participants who received study medication and yielded at least one measurement for that endpoint.||Score on a scale||Standard Deviation|Mean
649974|NCT02064907|Primary|AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval on Day 5|AUC(0-tau) is a measure of the area under the plasma concentration-time curve from time 0 to time tau over a dosing interval, where tau is the length of the dosing interval (24 hours).|Day 5 predose and up to 24 hours post-dose|Participants from the PK population - all participants who received at least 1 dose of study drug and had at least 1 measurable plasma concentration-with data available for analysis.||ng*hr/mL||Standard Deviation|Mean
649975|NCT02064907|Primary|AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity on Day 1|AUC(0-inf) is a measure of the area under the plasma concentration-time curve from time 0 extrapolated to infinity.|Day 1 predose and up to 24 hours post-dose|Participants from the PK population - all participants who received at least 1 dose of study drug and had at least 1 measurable plasma concentration-with data available for analysis.||ng*hr/mL||Standard Deviation|Mean
649976|NCT02064907|Primary|AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration on Day 5|AUC(0-tlqc) is a measure of total plasma exposure to a drug from time 0 to time of the last quantifiable concentration.|Day 5 predose and up to 24 hours post-dose|Participants from the PK population - all participants who received at least 1 dose of study drug and had at least 1 measurable plasma concentration-with data available for analysis.||ng*hr/mL||Standard Deviation|Mean
649977|NCT02064907|Primary|AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration on Day 1|AUC(0-tlqc) is a measure of total plasma exposure to a drug from time 0 to time of the last quantifiable concentration.|Day 1 predose and up to 24 hours post-dose|Participants from the PK population - all participants who received at least 1 dose of study drug and had at least 1 measurable plasma concentration-with data available for analysis.||ng*hr/mL||Standard Deviation|Mean
649978|NCT02064907|Primary|Cmax: Maximum Observed Plasma Concentration for Dexlansoprazole on Day 5|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Day 5 predose and up to 24 hours post-dose|Participants from the PK population - all participants who received at least 1 dose of study drug and had at least 1 measurable plasma concentration-with data available for analysis.||ng/mL||Standard Deviation|Mean
649979|NCT02064907|Primary|Cmax: Maximum Observed Plasma Concentration for Dexlansoprazole on Day 1.|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Day 1 predose and up to 24 hours post-dose|Participants from the PK population - all participants who received at least 1 dose of study drug and had at least 1 measurable plasma concentration-with data available for analysis.||ng/mL||Standard Deviation|Mean
649980|NCT02064894|Secondary|Serious Adverse Event - Side Effects and Serious Adverse Events|To verify the occurence of any serious adverse event, such as respiratory depression or deep sedation, during all the time-periods of the study|60, 90 and 120 minutes|||Participants|||Count of Participants
649981|NCT02064894|Primary|Pain Intensity - Percentage of Children Who Achieved VAS < 30 mm|"Percentage of participants which pain intensity has decreased under 30 mm on the VAS at 60 minutes.
The Visual Analogue Scale is a 0 to 100 mm continuous scale measuring the pain intensity. Score of 0=No Pain; Score of 100=Worst imaginable pain"|60 minutes post-analgesia|||Percentage of participants||95% Confidence Interval|Number
649982|NCT02064231|Primary|Degree of Leakage|Degree of leakage is measured on a 24 point scale where 0 represents no leakage (best possible outcome) and 24 represents leakage on the whole plate (worst possible outcome).|14 days|||units on a scale|baseplates|Standard Deviation|Mean
649983|NCT02064205|Secondary|Evaluate Effect of Pre-load on Satiety Hormones in Normal Weight and Overweight Women.|"The satiety hormones CCK, GLP-1, ghrelin and PYY are measured before (t=0) and after breakfast consumption (at t=30, 60, 90, 150, 240) . This is done on day 01, day 08, day 15 and day 22 with at least four days wash-out in-between.
The satiety hormones were only measured in the conditions when the pre-load was given with breakfast (condition A and B).
Area under the curves were calculated of the time curves."|Four hour curves (t=0, 30, 60, 90, 150 and 240 min) of day 01, day 08, day 15 and day 22.|Only in condition A and B blood was drawn and satiety hormones were analyzed.||(mcg*min)/mL||Standard Deviation|Mean
649985|NCT02064205|Primary|Energy Intake at an ad Libitum Lunch on a Test-day in Normal Weight and Overweight Women.|Yogurt with a polydextrose (fiber with satiating effect) is consumed in the morning with breakfast or later in the morning. The satiating effect of the addition of polydextrose is tested on the amount of food consumed with lunch four hours or 1.5h later.|Four hours or 1.5 hour after consumption of a pre-load at up to day 22|Energy intake||kJ||Standard Deviation|Mean
649989|NCT02063854|Secondary|Percentage of Participants With New Non-traumatic Vertebral Fractures (Including the Worsening of Pre-existing Fractures)|New non-traumatic vertebral fractures were identified by interpretable X-ray images of 13 vertebrae from the fourth thoracic to the fourth lumbar vertebra. A Central Review Committee member for X-ray determined the presence or absence of new vertebral fractures, the number of new fractures, the presence or absence of worsening pre-existing vertebral fractures, and the number of worsened fractures. The assessment of new vertebral fractures and the worsening of pre-existing vertebral fractures was semiquantitative. The X-ray images were visually inspected and classified into normal (Grade 0), mild deformation (Grade 1), moderate deformation (Grade 2), or severe deformation (Grade 3). If the assessment of any vertebra became worse by at least 1 grade after starting the treatment, its height was measured. A new vertebral fracture or a worsening pre-existing vertebral fracture was concluded if the vertebra’s height was reduced from the baseline by at least 20% and by at least 4 mm.|Baseline to Month 12|FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses.||percentage of participants|||Number
649990|NCT02063854|Secondary|Percent Change From Baseline in Bone Turnover Marker Urine Type 1 Collagen Cross-linked N-telopeptide (NTX) at Each Visit|Urine samples for urine bone turnover markers were collected at specified visits according to the study schedule. Urine samples were to be collected at about the same time of the day, as far as possible, throughout the study. Urine NTX was corrected by creatinine value.|Baseline and Months 1, 3, 6, 9 and 12 and End of Study (Last observation carried forward at Month 12)|"FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses. n in the category is the number of participants with data available at the given time-point."||percent change||Standard Deviation|Mean
649991|NCT02063854|Secondary|Percent Change From Baseline in Bone Turnover Marker Serum Procollagen 1 N-terminal Peptide (P1NP) at Each Visit|Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. Blood samples were to be collected at about the same time of the day, as far as possible, throughout the study.|Baseline and Months 1, 3, 6, 9 and 12 and End of Study (Last observation carried forward at Month 12)|"FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses. n in the category is the number of participants with data available at the given time-point."||percent change||Standard Deviation|Mean
649992|NCT02063854|Secondary|Percent Change From Baseline in Bone Turnover Marker Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Each Visit|Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. Blood samples were to be collected at about the same time of the day, as far as possible, throughout the study.|Baseline and Months 1, 3, 6, 9 and 12 and End of Study (Last observation carried forward at Month 12)|"FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses. n in the category is the number of participants with data available at the given time-point."||percent change||Standard Deviation|Mean
649993|NCT02063854|Secondary|Percent Change From Baseline in Bone Turnover Marker Serum Bone-type Alkaline Phosphatase (BAP) at Each Visit|Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. Blood samples were to be collected at about the same time of the day, as far as possible, throughout the study.|Baseline and Months 1, 3, 6, 9 and 12 and End of Study (Last observation carried forward at Month 12)|"FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses. n in the category is the number of participants with data available at the given time-point."||percent change||Standard Deviation|Mean
649994|NCT02063854|Secondary|Percent Change From Baseline in Bone Turnover Marker Serum Creatinine (CTX) at Each Visit|Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. Blood samples were to be collected at about the same time of the day, as far as possible, throughout the study.|Baseline and Months 1, 3, 6, 9 and 12 and End of Study (Last observation carried forward at Month 12)|"FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses. n in the category is the number of participants with data available at the given time-point."||percent change||Standard Deviation|Mean
649995|NCT02063854|Secondary|Percent Change From Baseline in Femur (Femoral Neck) BMD Measured by DXA at Each Visit|The change in BMD in the femur (femoral neck) at each visit relative to baseline. DXA is a means of measuring BMD through x-ray.|Baseline and Month 6, Month 12, and End of Study (Last observation carried forward at Month 12)|"FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses. n in the category is the number of participants with data available at the given time-point."||percent change||Standard Deviation|Mean
649996|NCT02063854|Secondary|Percent Change From Baseline in Femur (Trochanter) BMD Measured by DXA at Each Visit|The change in BMD in the femur (trochanter) at each visit relative to baseline. DXA is a means of measuring BMD through x-ray.|Baseline and Month 6, Month 12, and End of Study (Last observation carried forward at Month 12)|"FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses. n in the category is the number of participants with data available at the given time-point."||percent change||Standard Deviation|Mean
649997|NCT02063854|Secondary|Percent Change From Baseline in Femur (Total Proximal Femur) BMD Measured by DXA at Each Visit|The change in BMD in the total proximal femur (whole bone, trochanteric region, and neck region) at each visit relative to baseline. DXA is a means of measuring BMD through x-ray.|Baseline and Month 6, Month 12, and End of Study (Last observation carried forward at Month 12)|"FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses. n in the category is the number of participants with data available at the given time-point."||percent change||Standard Deviation|Mean
649998|NCT02063854|Secondary|Percent Change From Baseline in Mean Lumbar Spine (L2-L4) BMD Measured by DXA at Each Visit|The change in BMD in each vertebra, L2 to L4, and the averages of L2 to L4 at each visit relative to baseline. DXA is a means of measuring BMD through x-ray.|Baseline and Month 6, Month 12, and End of Study (Last observation carried forward at Month 12)|"FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses. n in the category is the number of participants with data available at the given time-point."||percent change||Standard Deviation|Mean
650038|NCT02062879|Primary|Total Daily Opioid Requirement|Daily breakthrough opioid requirement plus non-breakthrough opioid use in milligrams of morphine equivalents|Participants will be followed for their entire hospital stay, an expected average of 1 week.|||mg morphine equivalents/day||Inter-Quartile Range|Median
649999|NCT02063854|Primary|Percent Change From Baseline in Mean Lumbar Spine (L2-L4) Bone Mineral Density (BMD) Measured by Dual Energy X-Ray Absorptiometry (DXA) at End of Study|The change in BMD in the second to the fourth lumbar vertebrae, L2 to L4, and the averages of L2 to L4 at end of study relative to baseline. DXA is a means of measuring BMD through x-ray.|Baseline and End of Study (up to Month 12)|Full Analysis Set (FAS), all randomized participants who received at least 1 dose of study drug, with data available for analyses.||percent change||Standard Deviation|Mean
650000|NCT02063737|Secondary|Intentions Subscale of the SFAB|An individual’s intent to engage in behaviors that may promote improved alertness and reduced feelings of sleepiness or fatigue while at work with higher scores indicating greater intent. Range is 0 (strongly agree) to 100 (strongly disagree).|end of study at 90 day follow up|Intention to treat among participants with 90 day data (completers)||units on a scale||Standard Deviation|Mean
650001|NCT02063737|Secondary|Habits Subscale of the SFAB|Endorsement of behaviors that may promote improved alertness and reduced feelings of sleepiness or fatigue while at work ranging from 0 (strongly agree) to 100 (strongly disagree). Strongly agree (lower score) is associated with high level of endorsement of behaviors (habits) that promote improved alertness.|end of study at the 90 day follow up|Intention to treat among participants with 90 day data (completers)||units on a scale||Standard Deviation|Mean
650002|NCT02063737|Secondary|Environmental Constraints Three Subscale of the SFAB|Degree of importance of personal/work-life barriers that might limit ability to reduce feelings of fatigue and sleepiness while on duty. Scale ranges from 0 (not at all important) to 100 (very important). Higher scores indicate the individual perceives his/her responsibilities unrelated to the organization as factors that inhibit the individual’s ability to engage in behaviors that can improve alertness and reduce feelings of sleepiness or fatigue while at work|end of study at 90 day follow up|Intention to treat among participants with 90 day data (completers)||units on a scale||Standard Deviation|Mean
650003|NCT02063737|Secondary|Environmental Constraints Two Subscale of the SFAB|Degree of importance of employer policies that might limit ability to reduce feelings of fatigue and sleepiness while on duty. Scale ranges from 0 (not at all important) to 100 (very important). Higher scores indicate the individual perceives his/her employer’s policies and organizational related procedures/protocols as factors that inhibit the individual’s ability to engage in behaviors that can improve alertness and reduce feelings of sleepiness or fatigue while at work.|end of study at 90 day follow up|Intention to treat among participants with 90 day data (completers)||units on a scale||Standard Deviation|Mean
650004|NCT02063737|Secondary|Environmental Constraints One Subscale of the SFAB|Degree of importance of employer based barriers that might limit ability to reduce feelings of fatigue and sleepiness while on duty. Scale ranges from 0 (not at all important) to 100 (very important). Higher scores indicate the individual perceives his/her employer’s policies and organizational related procedures/protocols as factors that inhibit the individual’s ability to engage in behaviors that can improve alertness and reduce feelings of sleepiness or fatigue while at work.|end of study at 90 day follow up|Intention to treat among participants with 90 day data (completers)||units on a scale||Standard Deviation|Mean
650005|NCT02063737|Secondary|Importance Subscale of SFAB|Level of importance an individual places on the need to maintain alertness and reduce feelings of fatigue and/or sleepiness while at work ranging from 0 (strongly disagree) to 100 (strongly agree). Strongly agree (higher score) is associated with high level of importance (endorsement) placed on the need to maintain alertness and reduce feelings of fatigue while at work.|end of study at 90 day follow up|Intention to treat among participants with 90 day data (completers)||units on a scale||Standard Deviation|Mean
650006|NCT02063737|Secondary|Knowledge-two Subscale of the SFAB|Perceived degree of evidence that fatigue and sleepiness at work increases risks to safety ranging from 0 (strongly disagree) to 100 (strongly agree). Higher scores indicate an individual has a high-level of awareness for the negative effects of sleepiness and fatigue while at work, that may be attributed to the acquisition of information, an increased understanding, or through experiences or education.|end of study at 90 day follow up|Intention to treat among participants with 90 day data (completers)||units on a scale||Standard Deviation|Mean
650007|NCT02063737|Secondary|Knowledge-one Subscale of SFAB|Perception that fatigue and sleepiness at work increases risks to safety ranging from 0 (strongly disagree) to 100 (strongly agree). Higher scores indicate an individual has a high-level of awareness for the negative effects of sleepiness and fatigue while at work, that may be attributed to the acquisition of information, an increased understanding, or through experiences or education.|end of study at 90 day follow up|Intention to treat among participants with 90 day data (completers)||units on a scale||Standard Deviation|Mean
650008|NCT02063737|Secondary|Self Efficacy Subscale of the SFAB|Degree of confidence from 0 (cannot do at all) to 100 (highly certain can do) for completing activities. Higher scores indicate the individual has a high-level of self-confidence he/she can perform select behaviors that may improve alertness and reduce feelings of sleepiness or fatigue while at work.|end of study at 90 day follow up|Intention to treat among participants with 90 day data (completers)||units on a scale||Standard Deviation|Mean
650009|NCT02063737|Secondary|Normative Beliefs Scale Two Subscale of the SFAB|Belief of people's views if they thought you were very fatigued mentally or physically while at work. Scale ranges from 0 (strongly approve) to 100 (strongly disapprove). Higher scores indicate a person believes the social norms and beliefs of his/her social network possess a negative view of behaviors that places an individual at work while very sleepy or fatigued.|end of study at 90 day follow up|Intention to treat among participants with 90 day data (completers)||units on a scale||Standard Deviation|Mean
650010|NCT02063737|Secondary|Normative Beliefs Scale One Subscale of the SFAB|Belief of people's views if they thought you were sleepy and fighting the urge to sleep while at work. Scale ranges from 0 (strongly approve) to 100 (strongly disapprove). Higher scores indicate a person believes the social norms and beliefs of his/her social network possess a negative view of behaviors that places an individual at work while very sleepy or fatigued.|end of study at 90 day follow up|Intention to treat among participants with 90 day data (completers)||units on a scale||Standard Deviation|Mean
650011|NCT02063737|Secondary|Attitudes Two Subscale of the Sleep Fatigue and Alertness Behavior Tool|Individual attitudes towards maintaining alertness and reducing fatigue at work on future shifts. Scale ranges from 0 to 100 with higher scores indicating a more positive/favorable attitude towards maintaining alertness and reducing fatigue while at work.|end of study at 90 day follow up|Intention to treat among participants with 90 day data (completers)||units on a scale||Standard Deviation|Mean
650012|NCT02063737|Secondary|Attitude One Subscale of the Sleep Fatigue and Alertness Behavior (SFAB) Tool|Individual attitudes towards maintaining alertness and reducing fatigue at work. Scale ranges from 0 to 100 with higher scores indicating a more positive/favorable attitude towards maintaining alertness and reducing fatigue while at work.|Assessed at the end of 90-day study period|Intention to treat among participants with 90 day data (completers)||units on a scale||Standard Deviation|Mean
650013|NCT02063737|Primary|Self-Reported Fatigue at End of Shift Work|Self-reported fatigue based on scale ranging from 0 (Not At All) to 5 (Very Much).|At the end of scheduled work shifts during a 90 day study period|Analysis using intention to treat.||units on a scale|Participants|Standard Error|Least Squares Mean
650014|NCT02063659|Secondary|Change in the Frequency of Rescue Short-acting, Somatostatin Analog Used to Treat Carcinoid Syndrome Symptoms||Baseline and 12 weeks|Population only includes patients with both Baseline and Week 12 values.||frequency of dose count/day||Standard Deviation|Mean
650015|NCT02063659|Secondary|Change From Baseline in Abdominal Pain|Patients record the level of any abdominal pain they feel in the daily diary using an 11- point numeric rating system (NRS) based on the following: “Rate your worst abdominal (belly or tummy) pain in the past 24 hours, with “0” being “no pain” and “10” being “worst pain ever experienced”.”|Baseline and 12 weeks|Population only includes patients with both Baseline and Week 12 values.||units on a scale||Standard Deviation|Mean
650016|NCT02063659|Secondary|Change From Baseline in the Number of Cutaneous Flushing Episodes||Baseline and 12 weeks|Population only includes patients with both Baseline and Week 12 values.||Number of flushing episodes||Standard Deviation|Mean
650017|NCT02063659|Secondary|Change From Baseline in Stool Consistency|Patients rate stool consistency using the Bristol Stool Scale. The Bristol Stool Chart shows seven categories of stool. Type 1–2 indicate constipation, Type 3–4 are ideal stools as they are easier to pass, and Type 5–7 may indicate diarrhea and urgency.|Baseline and 12 weeks|Population only includes patients with both Baseline and Week 12 values.||units on a scale||Standard Deviation|Mean
650018|NCT02063659|Secondary|Change From Baseline in the Number of Daily Bowel Movements||Baseline and 12 weeks|Population only includes patients with both Baseline and Week 12 values.||bowel movements/day||Standard Deviation|Mean
650019|NCT02063659|Primary|Percent Change From Baseline in 24-hour Urinary 5-hydroxyindoleacetic Acid (5-HIAA)||Week 12|Population only includes patients with both Baseline and Week 12 values.||percentage of mg/24 hours||Standard Deviation|Mean
650020|NCT02063659|Primary|Incidence of Treatment-emergent Adverse Events||12 weeks|Safety population||Participants|||Count of Participants
650021|NCT02063516|Other Pre-specified|Amount of Air Added to Keep Cuff Pressure 60cmH20.|The accuracy of the intrinsic cuff pressure indicator is assessed by documenting which colour band the indicator is displaying when inflated according to manufacturers instructions, and measuring the numeric cuff pressure at the same time with a standard analogue cuff pressure gauge. The manufacturer has documented what pressure range is meant to be indicated by each of three colour ranges.|30 minutes, 60 minutes, 90 minutes and 120 minutes|||ml||Standard Deviation|Mean
650022|NCT02063516|Secondary|Anatomic Position|This will be determined fiberscopically via the airway tube over the full range of cuff volumes and at an intracuff pressure of 60 cm H2O.|5 min|"Fiber-optic scoring system:
1, clear view of vocal cord 2, Only arytenoids visible 3, Only epiglottis visible 4, No laryngeal structures visible"||participants|||Number
650023|NCT02063516|Primary|Oropharyngeal Seal Pressure|This will be measured over the full range of cuff volumes (0-40 ml) and at an intracuff pressure of 60 cm H2O.|5 min|||cmH2O||Standard Deviation|Mean
650024|NCT02063230|Primary|Dose Normalized Cmax, Unbound Selumetinib||0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post dose|||ng/mL/mg||Geometric Coefficient of Variation|Geometric Mean
650025|NCT02063230|Primary|Dose Normalized AUC, Unbound Selumetinib||0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post dose|||ng*h/mL/mg||Geometric Coefficient of Variation|Geometric Mean
650026|NCT02063230|Primary|Dose Normalized Cmax, Total Selumetinib||0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post dose|||ng/mL/mg||Geometric Coefficient of Variation|Geometric Mean
650027|NCT02063230|Primary|Dose Normalized AUC, Total Selumetinib||0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post dose|||ng*h/mL/mg||Geometric Coefficient of Variation|Geometric Mean
650028|NCT02063230|Primary|Cmax of Total Selumetinib||0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post dose|In the moderate group, 2 patients received Selumetinib 25mg and are not included here but are included in the Dose Normalised Cmax outcome measure||ng/mL||Geometric Coefficient of Variation|Geometric Mean
650029|NCT02063230|Primary|AUC (0 to Infinity) of Total Selumetinib||0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post dose|In the moderate group, 2 patients received Selumetinib 25mg and are not included here but are included in the Dose Normalised AUC outcome measure||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
650030|NCT02063035|Secondary|Post-operative Blood Transfusions During Hospitalization|All units of blood transfused during the hospital stay after surgery were recorded. One red blood cell unit contains 300 to 360 mL of whole blood.|From end of surgery on Day 1 to end of hospital stay up to approximately 5 days|||units of blood||Inter-Quartile Range|Median
650031|NCT02063035|Secondary|Hospital Length of Stay in Days|The number of days the participants stayed in the hospital after surgery was recorded.|From end of surgery on Day 1 to end of hospital stay up to approximately 2 weeks|||days||Inter-Quartile Range|Median
650032|NCT02063035|Secondary|Blood Loss Volume Following Surgery|Blood loss following surgery was defined as the total amount of fluid collected from the drain in the wound site during the hospital stay.|From end of surgery on Day 1 to end of hospital stay up to approximately 5 days|||mL||Inter-Quartile Range|Median
650033|NCT02063035|Primary|Change in Hemoglobin Level From Preoperative Appointment to Postoperative Hospital Discharge|Blood loss was calculated from the difference between the level of hemoglobin at the preoperative appointment and the lowest level during the postoperative hospitalization period. Reported here is the change in hemoglobin level after surgery. A negative number indicates a reduction in hemoglobin level.|From preoperative appointment approximately one week before surgery to end of hospital stay up to approximately 5 days after surgery|Only participants, for whom both preoperative and postoperative time points were collected, are reported in this outcome measure.||grams per deciliter (g/dL)||Inter-Quartile Range|Median
650042|NCT02062710|Primary|Change in Cough Reflex Sensitivity to Capsaicin|increase in C5 (decrease in cough reflex sensitivity). Capsaicin cough challenge involves subjects breathing in incremental doubling concentrations of aerosolized capsaicin, 1 minute apart, until the concentration of capsaicin (micromolar) inducing 5 or more coughs (C5) is reached.|2 hours after study drug administration|||log C5 (uM)||Standard Error|Mean
650043|NCT02062658|Primary|Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale|Patients given YBOCS (Yale Brown Obsessive-Compulsive Scale), a gold standard measure of obsessions and compulsions. For the YBOCS the minimum units are 0 and Maximum units on the total scale are 40. The higher the number on the YBOCS, the more severe the symptoms. Response was defined as at least a 35% reduction on the YBOCS.|2 weeks|||participants|||Number
650044|NCT02062645|Secondary|SBP and DBP in Patients With High Sodium Intake at Week 4 and 8|Change in systolic and diastolic blood pressure measured in office from baseline at week 4 and 8.|At week 4 and 8|All patients received amlodipine/valsartan 160/5 mg daily at Day 0 and were up titrated to amlodipine/valsartan 160/10 mg daily at visit 2 (week 4) if their hypertension can not be controlled. The duration of treatment period was 8 weeks.||mmHg||Standard Deviation|Mean
650045|NCT02062645|Secondary|Percentage of Participants With High Sodium Intake and Blood Pressure (BP) <140/90 mmHg at Week 4 and 8|Control rate of BP is defined as blood pressure lower than 140/90 mmHg at office visits in patients with high sodium intake (>100 mEq/day)|At week 4 and 8|The ITT (intent to treat) population defined as: met all entry criteria, received study drug and had at least one blood pressure measurement after Visit 1 (Day 0). One hundred patients had BP measurements at Visit 2 and 91 patients at Visit 3. LOCF (Visit 2 to Visit 3). Analysis performed both with original and imputed values||Percentage of participants|||Number
650046|NCT02062645|Secondary|Diastolic Blood Pressure (DBP) at Baseline, Week 4 and 8|Change in diastolic blood pressure measured in office from baseline at week 4 and week 8.|baseline, week 4, week 8|The ITT (intent to treat) population defined as: met all entry criteria, received study drug and had at least one blood pressure measurement after Visit 1 (Day 0). One hundred patients had BP measurements at Visit 2 and 91 patients at Visit 3. LOCF (Visit 2 to Visit 3). Analysis performed both with original and imputed values||mmHg||Standard Deviation|Mean
650047|NCT02062645|Secondary|Systolic Blood Pressure (SBP) at Baseline, Week 4 and 8|Change in systolic blood pressure measured in office from baseline at week 4 and 8.|baseline, week 4, week 8|The ITT (intent to treat) population defined as: met all entry criteria, received study drug and had at least one blood pressure measurement after Visit 1 (Day 0). One hundred patients had BP measurements at Visit 2 and 91 patients at Visit 3. LOCF (Visit 2 to Visit 3). Analysis performed both with original and imputed values||mmHg||Standard Deviation|Mean
650048|NCT02062645|Primary|Percentage of Participants With Blood Pressure (BP) <140/90 mmHg at Week 4 and 8|Control rate of BP defined as BP lower than 140/90 mmHg at office visits|At week 4 and 8|The ITT (intent to treat) population defined as: met all entry criteria, received study drug and had at least one blood pressure measurement after Visit 1 (Day 0). One hundred patients had BP measurements at Visit 2 and 91 patients at Visit 3. LOCF (Visit 2 to Visit 3). Analysis performed both with original and imputed values||Percentage of Participants|||Number
650049|NCT02062580|Secondary|Vaccine Immunogenicity|Percent of CD4+ T cells expressing Ki67 after stimulation in vitro with BCG.|6 weeks after BCG vaccination|Analysis population n is smaller than enrollment numbers as we calculated that that only 28 were needing in each arm to detect a difference.||percentage of Ki67% CD4+ T cells||Inter-Quartile Range|Median
650050|NCT02062580|Primary|T Cell Activation|Percentage of all CD4+ T cells expressing HLADR (NOT BCG-specific activation as in Tchakoute et al and as in secondary outcome). The n is smaller than the enrollment number as some participants were lost to follow-up, some were excluded due to HIV infection etc, and some samples did not have sufficient cells to analyse.|at 6 weeks|||percentage of CD4+ T cells||Inter-Quartile Range|Median
650051|NCT02062502|Secondary|Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, and Injection-site Pain/Tenderness After Vaccination 2||Up to 5 days after Vaccination 2|The analysis population is All Subjects as Treated with results after vaccination 2.||Percentage of participants|||Number
650052|NCT02062502|Secondary|Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, and Injection-site Pain/Tenderness After Vaccination 1||Up to 5 days after Vaccination 1|The analysis population is All Subjects as Treated with results after Vaccination 1.||Percentage of participants|||Number
650053|NCT02062502|Secondary|Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like Rash, Mumps-like Symptoms, and Injection-site Rash After Vaccination 2||Up to 42 days after Vaccination 2|The analysis population is All Subjects as Treated with results after vaccination 2||Percentage of participants|||Number
650054|NCT02062502|Secondary|Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like Rash, Mumps-like Symptoms, and Injection-site Rash After Vaccination 1||Up to 42 days after Vaccination 1|The analysis population is All Subjects as Treated with results after Vaccination 1.||Percentage of participants|||Number
650055|NCT02062502|Secondary|Percentage of Participants With Fever (>=102.2 °F Oral Equivalent)||Up to 42 days after Vaccination 1 and Vaccination 2 (up to 133 days)|The analysis population is All Subjects as Treated with temperature data at the time of assessment.||Percentage of participants|||Number
650056|NCT02062502|Primary|Geometric Mean Titer of VZV Antibodies|Antibody titers were measured with gpELISA.|6 weeks (43 days) after vaccination 1|The analysis population is participants with seronegative antibody titer at baseline and postvaccination serology contributing to the per-protocol analysis.||gpELISA units/mL||95% Confidence Interval|Geometric Mean
650057|NCT02062502|Primary|Percentage of Participants With Varicella Zoster Virus (VZV) Antibody Levels >=5 Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Units/mL||6 weeks (43 days) after vaccination 1|The analysis population is participants with a seronegative antibody titer at baseline and postvaccination serology contributing to the per-protocol analysis.||Percentage of participants|||Number
650058|NCT02062450|Primary|Implant Survivorship|Implant survivorship criteria was assessed by investigators during patients visits : is the implanted device still in place 2 years after surgery ? Negative answers were quantified.|2-year postoperative|||percentage of implants|||Number
650227|NCT02059187|Secondary|Percentage of Participants With Hemoglobin A1C <7% at Week 24|Percentage of participants with A1C <7.0% (53 mmol/mol) at Week 24.|Week 24|The analysis population included all randomized, treated participants with a Week 24 A1C measurement.||Percentage of participants|||Number
650059|NCT02062450|Secondary|Clinical Performance - HARRIS Score|The HARRIS score is a physician questionnaire assessing hip pain, function and mobility on a total of 100 points, 100 being the maximum score. A result between 90 and 100 points is considered “excellent”, between 80 and 90 “good”, between 70 and 80 “mediocre” and less than 70 “poor”.|2-year postoperative|||percentage of partipants|||Number
650060|NCT02062450|Secondary|Clinical Performance - HOOS Score|The HOOS (Hip disability and Osteoarthritis Outcome Score) is a patient questionnaire evaluating patients' feelings about their operated hip. It consists of 40 questions divided into 5 subgroups: pain, symptoms, daily living, quality of life, sports and recreational activities. Each category is scored on 100 points, 0 being the worse outcome and 100 the best outcome.|2 years postoperative|||units on a scale of 100||Standard Deviation|Mean
650061|NCT02062450|Secondary|Clinical Performance - PMA Score|"Postel-Merle-d'Aubigné (PMA) score is known since 1954 and is a very widespread mean of evaluating the clinical function of the hip by the physician.
It contains three items: pain, function and hip mobility, each noted on 6 points (0 is the worst possible score and 18 is the best possible score) :
a score between 15 and 18 points is defined as good,
a score between 12 and 14 points is defined as average,
a score inferior to 12 is defined as bad"|2 years postoperative|||units on a scale||Standard Deviation|Mean
650062|NCT02062450|Primary|Percentage of Participants With an Implant Dislocation After Surgery (= Dislocation Rate)|The primary safety outcome (implant dislocation) was assessed by a single question to the patients : Did you experience any implant dislocation since your surgery ? Positive answers were quantified.|2-year postoperative|||percentage of participants|||Number
650063|NCT02062450|Primary|Number of Participants With an Implant Dislocation After Surgery|The primary safety outcome (implant dislocation) was assessed by a single question to the patients : Did you experience any implant dislocation since your surgery ? Positive answers were quantified.|2-year postoperative|2 implants dislocations were reported in the 379 patients making up the Total Safety Population, of which 1 concerned a Primary surgery and the other concerned a Revision surgery. In both cases, orthopaedic reduction was performed without changing the implant.||participants|||Number
650064|NCT02062437|Other Pre-specified|General Performance: Radiological Assessment.|"Radiological assessment is based on :
Cup radiological signs of osteolysis or radiolucencies.
Stem radiological signs of osteolysis or radiolucencies.
Ossifications according to Brooker classification from class I: Ossification around the hip joint. to class IV: shows apparent bone ankylosis of the hip. (i.e Class 0 = no ossification)
Other Radiological signs"|2-year Follow-up visit|Patients with X-ray data available||participants|||Number
650065|NCT02062437|Other Pre-specified|General Performance: Objective Clinical Score (PMA)|Postel Merle d'Aubigne (PMA) rating contains three items; pain, function and hip mobility; each noted 0 to 6 points (0 is the worst possible score and 18 is the best possible PMA score).|2-year follow-up visit|Within per protocol population, data were not complete to calculate the total PMA score for 3 patients at 2-year visit.||score on a scale||Standard Deviation|Mean
650066|NCT02062437|Secondary|General Performance: Mobility|"Mobility of the hip is assessed by the maximum value in the range of motions, expressed in degrees (°).
Normal values (usually observed range of motions) are:
extension (from 0 to 30°), flexion (from 0 to 120°), abduction (from 0 to 45°), adduction (from 0 to 30°), external rotation (from 0 to 45°) and internal rotation (from 0 to 45°).
Higher values are the best and a negative value indicates that the patient(s) can't reach the minimum normal range of motion."|2-year Follow-up visit|80 patients were available but per-protocol some pre-operative data were not available for the analysis of mobilities||Degrees||Standard Deviation|Mean
650067|NCT02062437|Other Pre-specified|General Performance: Objective Clinical Score (PMA)|Postel Merle d'Aubigne (PMA) rating contains three items; pain, function and hip mobility; each noted 0 to 6 points (0 is the worst possible score and 18 is the best possible PMA score).|Baseline|Within per protocol population, data were not complete to calculate the total PMA score for 3 patients at 2-year visit.||score on a scale||Standard Deviation|Mean
650068|NCT02062437|Secondary|General Performance: Mobility|"Mobility of the hip is assessed by the maximum value in the range of motions, expressed in degrees (°).
Normal values (usually observed range of motions) are:
extension (from 0 to 30°), flexion (from 0 to 120°), abduction (from 0 to 45°), adduction (from 0 to 30°), external rotation (from 0 to 45°) and internal rotation (from 0 to 45°).
Higher values are the best and a negative value indicates that the patient(s) can't reach the minimum normal range of motion."|Baseline|80 patients were available but per-protocol some pre-operative data were not available for the analysis of mobilities||Degrees||Standard Deviation|Mean
650069|NCT02062437|Primary|Number of Participants With Adverse Events|"Surgical incidents.
Post-operative complications.
Failure and revisions analysis."|2-year follow-up visit|The total of 80 patients were seen for their 2-Year follow-up visit.||participants|||Number
650070|NCT02062385|Secondary|Percentage of Participants Seropositive to Diphtheria, Pertussis, or Tetanus Antigens|The percentage of participants seropositive to diphtheria, pertussis, or tetanus antigens was assessed. Seropositive was defined as the following: 1) anti-diphtheria antibody titers >=0.1 International Units (IU)/mL, 2) anti-tetanus antibody titers >=0.1 IU/mL, 3) antipertussis toxin antibody titers >=20 Enzyme-linked Immunosorbent Assay (ELISA) Units (EU)/mL, 4) anti-pertussis filamentous hemagglutinin (FHA) antibody titers >=20 EU/mL. This outcome was evaluated only in participants receiving concomitant administration of V260 and EPI.|Baseline and between 28 and 51 days after the third DTaP vaccination|Participants in the concomitant EPI groups who receive their scheduled doses of DTaP without intervening disease specific to the antigen before the blood sample collection postdose 3, adhere to the guidelines for administration of vaccine, and have valid values available for analysis within specified day ranges.||Percentage of participants||95% Confidence Interval|Number
650071|NCT02062385|Secondary|Percentage of Participants With Any Adverse Event|An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the sponsor’s product, is also an adverse event.|Up to 30 days after any dose of V260 or Placebo|All Subjects as Treated with safety follow-up||Percentage of participants|||Number
653973|NCT01972659|Primary|TOF 0.9 Achieving Time||end of the surgery|||minutes||Standard Deviation|Mean
650072|NCT02062385|Secondary|Percentage of Participants Who Achieved Seroprotection Against Poliovirus Type 1, 2, or 3|The percentage of participants who achieved seroprotection against poliovirus Type 1, 2, or 3 was assessed. Seroprotection was defined as a neutralizing antibody titer >=1:8. This outcome was evaluated only in participants receiving concomitant administration of V260 and OPV.|Baseline and between 28 and 56 days after the third OPV vaccination|Participants in the concomitant EPI groups who receive their scheduled doses of OPV without intervening disease specific to the antigen before the blood sample collection postdose 3, adhere to the guidelines for administration of vaccine, and have valid values available for analysis within specified day ranges.||Percentage of participants||95% Confidence Interval|Number
650073|NCT02062385|Secondary|Number of Participants With Severe Rotavirus Gastroenteritis|The number of participants with severe rotavirus gastroenteritis (RVGE) caused by naturally-occurring wild-type rotavirus (regardless of serotype or disease severity) was assessed. The case definition of RVGE included 1) 3 or more watery or looser-than-normal stools within a 24-hour period and/or forceful vomiting, and 2) naturally-occurring wild-type rotavirus must be detected in a stool specimen taken within 7 days after the onset of symptoms. Severe RVGE was defined as >=11 on the Vesikari Scoring System, a composite of the seven parameters related to symptoms and treatment with an overall range from 0 to 20.|From 14 days after the third dose of V260 or placebo through the first rotavirus season (up to 15 months)|Participants who were vaccinated in either the staggered EPI or concomitant EPI groups, were not protocol violators, and were classified as evaluable for RVGE according to the per-protocol case definition.||Participants|||Number
650074|NCT02062385|Secondary|Percentage of Participants With Intussusception|Episodes of intussusception were collected from the time of written consent until the end of study. The percentage of participants with an episode of intussusception was assessed.|Up to 15 months|All Subjects as Treated with safety follow-up||Percentage of participants|||Number
650075|NCT02062385|Secondary|Percentage of Participants With Vomiting or Diarrhea|Episodes of vomiting and diarrhea were noted by the guardian and recorded on the Vaccination Record Card during Day 1 to Day 14 after each dose of vaccination. Vomiting and diarrhea reported by the guardian were also collected as an adverse event during Day 15 to Day 30 after any dose of vaccination. The percentage of participants with an episode or an adverse event of vomiting or diarrhea was assessed.|Up to 30 days after any dose of V260 or Placebo|All Subjects as Treated with safety follow-up||Percentage of participants|||Number
650076|NCT02062385|Secondary|Percentage of Participants With Elevated Temperature|Elevated temperature (temperature >=37.5°C axillary or equivalent) was noted by the guardian and recorded on the Vaccination Report Card during Day 1 to Day 14 after each dose of vaccination. Elevated temperature reported by the guardian was also collected as an adverse event (pyrexia) during Day 15 to Day 30 after each dose of vaccination. The percentage of participants with axillary temperature >=37.5 °C or an adverse event of pyrexia was assessed.|Up to 30 days after any dose of V260 or Placebo|All Subjects as Treated with follow-up specific to the endpoint||Percentage of participants|||Number
650077|NCT02062385|Primary|Number of Participants With Any Severity of Rotavirus Gastroenteritis|The number of participants with rotavirus gastroenteritis (RVGE) caused by naturally-occurring wild-type rotavirus (regardless of serotype or disease severity) was assessed. The case definition of RVGE included 1) 3 or more watery or looser-than-normal stools within a 24-hour period and/or forceful vomiting, and 2) naturally-occurring wild-type rotavirus must be detected in a stool specimen taken within 7 days after the onset of symptoms.|From 14 days after the third dose of V260 or placebo through the first rotavirus season (up to 15 months)|Participants who were vaccinated in either the staggered EPI or concomitant EPI groups, were not protocol violators, and were classified as evaluable for RVGE according to the per-protocol case definition.||Participants|||Number
650078|NCT02062359|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|3 months|||participants|||Number
650079|NCT02062359|Secondary|Persistence of Genetically Engineered, Adoptively Transferred Cluster of Differentiation 62L (CD62L) + Derived Lymphocytes|Estimate the persistence of cells via enzyme linked immunosorbent spot (ELISPOT) and tetramer analysis by fluorescence activated cell sorting (FACS).|3 months|No data was collected or analyzed, thus we did not perform an evaluation of persistence for this trial. The reason is that we did not accrue a sufficient number of patients in a timely manner. A minimum of 22 subjects was needed to perform an analysis.|||||
650080|NCT02062359|Primary|Objective Response (Complete Response (CR) + Partial Response (PR)) of Melanoma Tumors|Response was determined by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progression (PD) is at least a 20% increase in the sum of the LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.|3 months|None of the participants achieved a complete response or partial response and no data were collected for this assessment.|||||
650081|NCT02062294|Secondary|Number of Participants With Any Serious Adverse Events (SAEs) or Adverse Events (AEs)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.|6 months|Safety Analysis population (SAP) comprised all 14 participants which entered study.||participants|||Number
650082|NCT02062294|Primary|Proportion of Patients Developing Cytomegalovirus (CMV) Disease Within 6 Months of Liver Transplantation Under Valcyte Prophylaxis|Participants with clinical manifestation of CMV disease within 6 months after liver transplantation under Valcyte prophylaxis were evaluated.|6 months|Per Protocol (PP) population comprised all 14 participants receiving Valganciclovir within 10 days post-transplantation for at least 70 days and for whom source data from the time period between liver transplantation until 6 months post-transplantation was available.||participants|||Number
650083|NCT02062177|Secondary|Number of Participants With Adverse Events as a Measure of Safety|Number of patients with adverse events (hypotension, bradycardia, hypoxemia,...)|one day||||||
650084|NCT02062177|Secondary|Time (Minutes) to Dischargeability of Patient From Endoscopic Unit|After endoscopy, patients will be transferred to recovery area and evaluated every 5 minutes until they will be ready to be discharged from the Endoscopy Unit. Recovery will be assessed using the Modified Aldrete Scoring System; patients will be considered fit for discharge with a Modified Aldrete Scoring System score of 18 or more, stable vital signs and without nausea, vomiting, or itching.|one day||||||
650085|NCT02062177|Primary|Patient's Satisfaction (Visual Analog Scale) About Sedation 24-72 Hours After Procedure|Patients will be contacted by telephone 24-72 hours after discharge and asked about their satisfaction about the quality of sedation, rated on a verbal rating scale, from 0 to 100 (0=dissatisfaction; 100=complete satisfaction)|at 24-72 hours after procedure|||units on a scale||Standard Deviation|Mean
650086|NCT02062177|Primary|Patient's Satisfaction (Visual Analog Scale) About Sedation Before Discharge|When completely awake, patients will be asked to rate the degree of pain/discomfort and the degree of satisfaction about quality of sedation from 0 to100 (0=dissatisfaction - 100=complete satisfaction)|before discharge|||units on a scale||Standard Deviation|Mean
650087|NCT02062177|Primary|Endoscopist's Satisfaction (Visual Analog Scale) About Sedation|Visual Analog Scale from 0 to100 (0=dissatisfaction - 100=complete satisfaction) will be used to assess the technical difficulty of examination and the satisfaction with sedation of patient experienced by endoscopist|at the end of the exam|||units on a scale||Standard Deviation|Mean
650088|NCT02061748|Secondary|All-cause Death (Post-hoc Analysis)|"This outcome measure describes the incidence of death for dabigatran and warfarin in the post-hoc analysis.
A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.||Events per 1000 patient-years||95% Confidence Interval|Number
650089|NCT02061748|Secondary|All-cause Death (Primary Analysis)|This outcome measure describes the incidence of death for dabigatran and warfarin in the primary analysis. Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.||Events per 1000 patient-years||95% Confidence Interval|Number
650090|NCT02061748|Secondary|Pulmonary Embolism (Post-hoc Analysis)|"This outcome measure describes the incidence of pulmonary embolism for dabigatran and warfarin in the post-hoc analysis.
Pulmonary embolism includes acute pulmonary heart disease. A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.||Events per 1000 patient-years||95% Confidence Interval|Number
650091|NCT02061748|Secondary|Pulmonary Embolism (Primary Analysis)|This outcome measure describes the incidence of pulmonary embolism for dabigatran and warfarin in the primary analysis. Pulmonary embolism includes acute pulmonary heart disease. Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.||Events per 1000 patient-years||95% Confidence Interval|Number
650092|NCT02061748|Secondary|Deep Vein Thrombosis (Post-hoc Analysis)|"This outcome measure describes the incidence of deep vein thrombosis for dabigatran and warfarin in the post-hoc analysis.
Deep vein thrombosis includes phlebitis and thrombophlebitis and other venous embolism and thrombosis.
A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.||Events per 1000 patient-years||95% Confidence Interval|Number
650093|NCT02061748|Secondary|Deep Vein Thrombosis (Primary Analysis)|This outcome measure describes the incidence of deep vein thrombosis for dabigatran and warfarin in the primary analysis. Deep vein thrombosis includes phlebitis and thrombophlebitis and other venous embolism and thrombosis. Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.||Events per 1000 patient-years||95% Confidence Interval|Number
650109|NCT02061748|Secondary|Major GI Bleeding (Primary Analysis)|"This outcome measure describes the incidence of major GI bleeding for dabigatran and warfarin in the primary analysis. Major GI bleeding includes major upper GI bleeding and major lower GI bleeding.
Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.||Events per 1000 patient-years||95% Confidence Interval|Number
650094|NCT02061748|Secondary|Venous Thromboembolism (Post-hoc Analysis)|"This outcome measure describes the incidence of venous thromboembolism for dabigatran and warfarin in the post-hoc analysis.
Venous thromboembolism includes the deep vein thrombosis and the pulmonary embolism.
A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.||Events per 1000 patient-years||95% Confidence Interval|Number
650095|NCT02061748|Secondary|Venous Thromboembolism (Primary Analysis)|"This outcome measure describes the incidence of venous thromboembolism for dabigatran and warfarin in the primary analysis. Venous thromboembolism includes the deep vein thrombosis and the pulmonary embolism.
Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.||Events per 1000 patient-years||95% Confidence Interval|Number
650096|NCT02061748|Secondary|MI (Post-hoc Analysis)|"This outcome measure describes the incidence of MI for dabigatran and warfarin in the post-hoc analysis.
MI includes the acute myocardial infarction. A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.||Events per 1000 patient-years||95% Confidence Interval|Number
650097|NCT02061748|Secondary|Myocardial Infarction (MI) (Primary Analysis)|This outcome measure describes the incidence of MI for dabigatran and warfarin in the primary analysis. MI includes the acute myocardial infarction. Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.||Events per 1000 patient-years||95% Confidence Interval|Number
650098|NCT02061748|Secondary|TIA (Post-hoc Analysis)|"This outcome measure describes the incidence of TIA for dabigatran and warfarin in the post-hoc analysis.
TIA includes transient cerebral ischemia as the principal (primary) discharge diagnosis.
A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.||Events per 1000 patient-years||95% Confidence Interval|Number
650099|NCT02061748|Secondary|Transient Ischemic Attack (TIA) (Primary Analysis)|"This outcome measure describes the incidence of TIA for dabigatran and warfarin in the primary analysis. TIA includes transient cerebral ischemia as the principal (primary) discharge diagnosis.
Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.||Events per 1000 patient-years||95% Confidence Interval|Number
650100|NCT02061748|Secondary|Other Major Bleeds (Post-hoc Analysis)|"This outcome measure describes the incidence of other major bleeds for dabigatran and warfarin in the post-hoc analysis.
Other major bleeds includes hemarthrosis, hemopericardium, hemoptysis, epistaxis, hemorrhage (not specified) and acute posthemorrhagic anemia.
A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.||Events per 1000 patient-years||95% Confidence Interval|Number
650101|NCT02061748|Secondary|Other Major Bleeds (Primary Analysis)|"This outcome measure describes the incidence of other major bleeds for dabigatran and warfarin in the primary analysis. Other major bleeds includes hemarthrosis, hemopericardium, hemoptysis, epistaxis, hemorrhage (not specified) and acute posthemorrhagic anemia.
Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.||Events per 1000 patient-years||95% Confidence Interval|Number
650132|NCT02061683|Secondary|Percentage of Patients With an Adverse Event of Conjunctival Hyperemia|Conjunctival hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). An adverse event is any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.|3 Months|Safety population defined as all enrolled patients who completed at least 1 follow-up visit||Percentage of Patients|||Number
650102|NCT02061748|Secondary|Major Urogenital Bleeding (Post-hoc Analysis)|"This outcome measure describes the incidence of major urogenital bleeding for dabigatran and warfarin in the post-hoc analysis.
Major urogenital bleeding includes hematuria and excessive/frequent menstruation and secondary diagnosis indicating acute bleeding (anemia).
A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.||Events per 1000 patient-years||95% Confidence Interval|Number
650103|NCT02061748|Secondary|Major Urogenital Bleeding (Primary Analysis)|"This outcome measure describes the incidence of major urogenital bleeding for dabigatran and warfarin in the primary analysis. Major urogenital bleeding includes hematuria and excessive/frequent menstruation and secondary diagnosis indicating acute bleeding (anemia).
Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.||Events per 1000 patient-years||95% Confidence Interval|Number
650104|NCT02061748|Secondary|Major Lower GI Bleeding (Post-hoc Analysis)|"This outcome measure describes the incidence of major lower GI bleeding for dabigatran and warfarin in the post-hoc analysis.
Major lower GI bleeding includes diverticulosis or diverticulitis of small intestine or of colon with hemorrhage, hemorrhage of rectum and anus, angiodysplasia of intestine with hemorrhage, blood in stool and hemorrhage of GI tract (unspecified).
A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.||Events per 1000 patient-years||95% Confidence Interval|Number
650105|NCT02061748|Secondary|Major Lower GI Bleeding (Primary Analysis)|"This outcome measure describes the incidence of major lower GI bleeding for dabigatran and warfarin in the primary analysis. Major lower GI bleeding includes diverticulosis or diverticulitis of small intestine or of colon with hemorrhage, hemorrhage of rectum and anus, angiodysplasia of intestine with hemorrhage, blood in stool and hemorrhage of GI tract (unspecified).
Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.||Events per 1000 patient-years||95% Confidence Interval|Number
650106|NCT02061748|Secondary|Major Upper GI Bleeding (Post-hoc Analysis)|This outcome measure describes the incidence of major upper GI bleeding for dabigatran and warfarin in the post-hoc analysis. Major upper GI bleeding includes acute, chronic or unspecified gastric ulcer, acute duodenal ulcer, chronic or unspecified duodenal ulcer, acute, chronic or unspecified peptic ulcer, acute, chronic or unspecified gastrojejunal ulcer with hemorrhage with/without (w/wo) obstruction and with hemorrhage and perforation w/wo obstruction, hematemesis, endoscopic control of gastric or duodenal bleeding, upper gastrointestinal endoscopy including esophagus, stomach, and either the duodenum and/or jejunum as appropriate with control of bleeding, any method. A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. This was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization.|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.||Events per 1000 patient-years||95% Confidence Interval|Number
650107|NCT02061748|Secondary|Major Upper GI Bleeding (Primary Analysis)|This outcome measure describes the incidence of major upper GI bleeding for dabigatran and warfarin in the primary analysis. Major upper GI bleeding includes acute gastric ulcer, chronic or unspecified gastric ulcer, acute duodenal ulcer, chronic or unspecified duodenal ulcer, acute, chronic or unspecified peptic ulcer, acute gastrojejunal ulcer, chronic or unspecified gastrojejunal ulcer with hemorrhage with/without obstruction and with hemorrhage and perforation with/without obstruction, hematemesis, endoscopic control of gastric or duodenal bleeding, upper gastrointestinal endoscopy including esophagus, stomach, and either the duodenum and/or jejunum as appropriate with control of bleeding, any method. Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.||Events per 1000 patient-years||95% Confidence Interval|Number
650108|NCT02061748|Secondary|Major GI Bleeding (Post-hoc Analysis)|"This outcome measure describes the incidence of major GI bleeding for dabigatran and warfarin in the post-hoc analysis. Major GI bleeding includes major upper GI bleeding and major lower GI bleeding.
A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.||Events per 1000 patient-years||95% Confidence Interval|Number
650110|NCT02061748|Secondary|Major Extracranial Bleeding (Post-hoc Analysis)|"This outcome measure describes the incidence of major extracranial bleeding for dabigatran and warfarin in the post-hoc analysis. Major extracranial bleeding includes: major gastrointestinal (GI) bleeding, major urogenital bleeding and major other bleeding.
A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.||Events per 1000 patient-years||95% Confidence Interval|Number
650111|NCT02061748|Secondary|Major Extracranial Bleeding (Primary Analysis)|"This outcome measure describes the incidence of major extracranial bleeding for dabigatran and warfarin in the primary analysis. Major extracranial bleeding includes: major gastrointestinal (GI) bleeding, major urogenital bleeding and major other bleeding.
Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.||Events per 1000 patient-years||95% Confidence Interval|Number
650112|NCT02061748|Secondary|Major Intracranial Bleeding (Post-hoc Analysis)|"This outcome measure describes the incidence of major intracranial bleeding for dabigatran and warfarin in the post-hoc analysis. Major intracranial bleeding includes: Subarachnoid hemorrhage, intracerebral hemorrhage, other and unspecified intracranial hemorrhage, subarachnoid, subdural or extradural hemorrhage following injury without mention of open intracranial wound other and unspecified intracranial hemorrhage following injury without mention of open intracranial wound but excludes these codes if concomitant discharge diagnosis of major trauma was present.
A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.||Events per 1000 patient-years||95% Confidence Interval|Number
650113|NCT02061748|Secondary|Major Intracranial Bleeding (Primary Analysis)|"This outcome measure describes the incidence of major intracranial bleeding for dabigatran and warfarin in the primary analysis. Major intracranial bleeding includes: Subarachnoid hemorrhage, intracerebral hemorrhage, other and unspecified intracranial hemorrhage, subarachnoid, subdural or extradural hemorrhage following injury without mention of open intracranial wound other and unspecified intracranial hemorrhage following injury without mention of open intracranial wound but excludes these codes if concomitant discharge diagnosis of major trauma was present.
Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.||Events per 1000 patient-years||95% Confidence Interval|Number
650114|NCT02061748|Secondary|Hemorrhagic Stroke (Post-hoc Analysis)|"This outcome measure describes the incidence of hemorrhagic stroke for dabigatran and warfarin in the post-hoc analysis. Hemorrhagic stroke includes: Subarachnoid hemorrhage and intracerebral hemorrhage but excludes these codes if “traumatic brain injury” or “rehabilitation care” as primary code is present.
A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.||Events per 1000 patient-years||95% Confidence Interval|Number
650115|NCT02061748|Secondary|Hemorrhagic Stroke (Primary Analysis)|"This outcome measure describes the incidence of hemorrhagic stroke for dabigatran and warfarin in the primary analysis. Hemorrhagic stroke includes: subarachnoid hemorrhage, intracerebral hemorrhage but excludes these codes if “traumatic brain injury” or “rehabilitation care” as primary code is present.
Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.||Events per 1000 patient-years||95% Confidence Interval|Number
650116|NCT02061748|Secondary|Ischemic Stroke (Post-hoc Analysis)|"This outcome measure describes the incidence of ischemic stroke for dabigatran and warfarin in the post-hoc analysis. Ischemic stroke includes: Occlusion and stenosis of precerebral arteries with cerebral infarction, Occlusion of cerebral arteries with cerebral infarction and Acute, but ill-defined, cerebrovascular disease but excludes above diagnosis if hospitalization lasted less than 48 hours and was accompanied by carotid endarterectomy.
A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.||Events per 1000 patient-years||95% Confidence Interval|Number
650117|NCT02061748|Secondary|Ischemic Stroke (Primary Analysis)|"This outcome measure describes the incidence of ischemic stroke for dabigatran and warfarin in the primary analysis. Ischemic stroke includes: Occlusion and stenosis of precerebral arteries with cerebral infarction, Occlusion of cerebral arteries with cerebral infarction and Acute, but ill-defined, cerebrovascular disease but excludes above diagnosis if hospitalization lasted less than 48 hours and was accompanied by carotid endarterectomy.
Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.||Events per 1000 patient-years||95% Confidence Interval|Number
650118|NCT02061748|Primary|Major Bleeding (Post-hoc Analysis)|This outcome measure describes the incidence of major bleeding (Inclusive of hemorrhagic stroke, major intracranial bleeding and major extracranial bleeding) for dabigatran and warfarin in the post-hoc analysis. A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization.|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.||Events per 1000 patient-years||95% Confidence Interval|Number
650119|NCT02061748|Primary|Major Bleeding (Primary Analysis)|"This outcome measure describes the incidence of major bleeding (hemorrhagic stroke, major intracranial bleeding and major extracranial bleeding) for dabigatran and warfarin in the primary analysis.
Major Intracranial Bleeding includes subarachnoid hemorrhage, intracerebral hemorrhage, other and unspecified intracranial hemorrhage, subarachnoid hemorrhage following injury without mention of open intracranial wound, subdural hemorrhage following injury without mention of open intracranial wound, extradural hemorrhage following injury without mention of open intracranial wound, other and unspecified intracranial hemorrhage following injury without mention of open intracranial wound but excludes these codes if major trauma was present. Major extracranial bleeding includes major gastrointestinal (GI) bleeding, major urogenital bleeding and major other bleeding. Either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization were used."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.||Events per 1000 patient-years||95% Confidence Interval|Number
650120|NCT02061748|Primary|Stroke (Post-hoc Analysis)|This outcome measure describes the incidence of stroke (hemorrhagic and ischemic) for dabigatran and warfarin in the post-hoc analysis. A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization.|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.||Events per 1000 patient-years||95% Confidence Interval|Number
650121|NCT02061748|Primary|Stroke (Primary Analysis)|"This outcome measure describes the incidence of stroke (hemorrhagic and ischemic) for dabigatran and warfarin in the primary analysis.
Ischemic stroke includes: Occlusion and stenosis of precerebral arteries with cerebral infarction, Occlusion of cerebral arteries with cerebral infarction and Acute, but ill-defined, cerebrovascular disease but excludes above diagnosis if hospitalization lasted less than 48 hours and was accompanied by carotid endarterectomy.
Hemorrhagic stroke includes: Subarachnoid hemorrhage (SAH) and Intracerebral hemorrhage (ICH) but excludes previous listed diagnoses if “traumatic brain injury” or “rehabilitation care” is present.
Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.||Events per 1000 patient-years||95% Confidence Interval|Number
650122|NCT02061696|Other Pre-specified|Pain Score||Up to 37 days post procedure||||||
650123|NCT02061696|Other Pre-specified|Patient Satisfaction|Assessed by a patient satisfaction questionnaire.|Upt to 37 days post procedure||||||
650124|NCT02061696|Secondary|Minor Access Site Related Complications|Observation of any minor access site related complications.|Up to 37 days post procedure||||||
650125|NCT02061696|Secondary|Ability to Sit up at a 45 Degree Angle|Defined as the ability to sit up at 45 degree angle within 15 minutes of successful hemostasis without re-bleed|within 15 minutes of successful hemostasis||||||
650126|NCT02061696|Secondary|Time to Ambulation|The time the procedural sheath is removed and the subject can stand or walk 20 ft without rebleeding. Ambulation to be evaluated at 1, 2, and 4 hours post sheath removal until the subject can ambulate.|Up to 1 day post procedure||||||
650127|NCT02061696|Secondary|Time to Actual Discharge|Discharge following procedural sheath removal until actual discharge.|Up to 1 day post procedure||||||
650128|NCT02061696|Secondary|Time to Discharge Eligibility|The time from sheath removal and ambulation to when subject can be discharged after examination of access site.|Up to 1 day post procedure||||||
650129|NCT02061696|Secondary|Time to Hemostasis|Difference between the time the procedural sheath is removed and hemostasis is observed.|Participants will be followed from procedural sheath removal until hemostasis is achieved, an average of 15 minutes||||||
650130|NCT02061696|Secondary|AXERA 2 Access System Success|Achievement of femoral artery access with AXERA and placement of procedural sheath.|At the time of the femoral artery access procedure up to 1 hour post procedure||||||
650131|NCT02061696|Primary|Observation of Any Site Related Major Adverse Events|Observation of any major access site related complications (number of participants).|Up to 37 days post procedure|||Participants|||Count of Participants
650133|NCT02061683|Primary|Intraocular Pressure (IOP) in the Study Eye|IOP is a measure of the fluid pressure inside the study eye. Patients were categorized by pre-study therapies and the bimatoprost-containing study therapy into the following 5 groups: Group A (pre-study: treatment naïve; during study: bimatoprost monotherapy); Group B (pre-study: prostaglandin analog [PGA] monotherapy, excluding bimatoprost; during study: bimatoprost monotherapy); Group C (pre-study: non-PGA monotherapy or combination therapy; during study: bimatoprost monotherapy); Group D (pre-study: combination therapy including PGA, without bimatoprost; during study: pre-study combination therapy with PGA switched to bimatoprost); and Group E (pre-study: non-PGA monotherapy or combination therapy; during study: bimatoprost adjunctive to pre-study therapy).|Month 3|All enrolled patients with data available for analysis||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
650134|NCT02061592|Primary|Monocular logMar Visual Acuity - Standard Low Contrast Bright|LogMar visual acuity within each eye was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts. A LogMar acuity value of 0 indicates that a subject has 20/20 vision. Positive LogMar acuity values indicate worsened vision while negative LogMar acuity values would indicated improved vision.|1- week Follow-up|Analysis population consisted of subjects that successfully completed all study visits without any major protocol deviations.||LogMar|Participants|Standard Deviation|Mean
650135|NCT02061592|Primary|Monocular Logarithm of the Minimum Angle of Resolution (logMAR) Visual Acuity - Standard High Contrast Dim|LogMar visual acuity within each eye was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts. A LogMar acuity value of 0 indicates that a subject has 20/20 vision.Positive LogMar acuity values indicate worsened vision while negative LogMar acuity values would indicated improved vision.|1-week follow-up|Consisted of subjects that successfully completed all study visits without any major protocol deviations. 13 Subjects were not included in the analysis population due to study procedures not properly followed from one of the investigational sites where the measured results were not collected in the lighting conditions described in the protocol.||LogMar|Participants|Standard Deviation|Mean
650136|NCT02061592|Primary|Overall Vision|Subjective assessment of vision was performed using the Contact Lens User Experience TM (CLUE) questionnaire. CLUE was a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact lens-wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicated a more favorable/positive response with a range of 0 to 120.|1- week Follow-up|Analysis population consisted of subjects that successfully completed the study visits without any major protocol deviations.||units on a scale||Standard Deviation|Mean
650137|NCT02061592|Primary|Overall Comfort|Subjective assessment of comfort was performed using the Contact Lens User Experience TM (CLUE) questionnaire. CLUE was a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact lens- wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicated a more favorable/positive response with a range of 0 to 120.|1-week follow-up|Analysis population consisted of subjects that successfully completed the study visits without any major protocol deviations.||units on a scale||Standard Deviation|Mean
650138|NCT02061540|Other Pre-specified|Change From Baseline for Other Biochemical Markers of Cholestasis: Total Cholesterol, Low Density Lipoprotein Cholesterol|Total cholesterol (TC) level and low density lipoprotein cholesterol (LDLC) level were considered as biochemical markers of cholestasis.|Baseline, Week 14|mITT population included all participants who received at least 1 dose of investigational product and had at least 1 post baseline serum bile acid laboratory assessment.||mg/dL||Standard Deviation|Mean
650139|NCT02061540|Secondary|Change From Baseline in Pruritus as Measured by Adult Itch Reported Outcome (ItchRO) Weekly Sum Score|The Adult ItchRO instrument was completed twice daily using an electronic diary (eDiary). Each morning and evening score had a range from 0-10, with the higher score indicating increasing itch severity. The following was used for assessing the Adult ItchRO daily score: The score which represented the most severe itching for the day (morning or evening) was taken for each day as the daily score (maximum daily score of 10); If only 1 of the 2 scores was available for the day, the score that was available was used as the daily score; If both the morning and the evening scores were missing, the score was considered missing for the day.|Baseline, Week 14|mITT population included all participants who received at least 1 dose of investigational product and had at least 1 post baseline serum bile acid laboratory assessment.||units on scale||Standard Deviation|Mean
650140|NCT02061540|Secondary|Change From Baseline in Bilirubin Levels at Week 14|Total Bilirubin and Direct (Conjugated) Bilirubin levels were evaluated.|Baseline, Week 14|mITT population included all participants who received at least 1 dose of investigational product and had at least 1 post baseline serum bile acid laboratory assessment.||milligram per deciliter (mg/dL)||Standard Deviation|Mean
650141|NCT02061540|Secondary|Change From Baseline in Liver Enzyme Levels in Serum|Levels of liver enzymes such as Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) in serum were evaluated.|Baseline, Week 14|mITT population included all participants who received at least 1 dose of investigational product and had at least 1 post baseline serum bile acid laboratory assessment.||units per liter (U/L)||Standard Deviation|Mean
650142|NCT02061540|Primary|Change From Baseline in Fasting Serum Bile Acid Level at Week 14|Serum bile acid levels were evaluated using blood samples collected.|Baseline, Week 14|Modified intent-to-treat (mITT) population included all participants who received at least 1 dose of investigational product and had at least 1 post baseline serum bile acid laboratory assessment.||micromoles per liter||Standard Deviation|Mean
650143|NCT02061540|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|An Adverse Event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding, for example), symptom, or disease temporally associated with the study or use of investigational drug product, whether or not the AE was considered to be related to the investigational drug product. TEAEs were AEs with a start date on or after the first dose of investigational product and started prior to the last dose of investigational product plus 14 days.|From start of study drug administration until Week 18|Safety population included all participants who received at least 1 dose of the investigational product.||participant|||Number
655248|NCT01953328|Secondary|Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
650144|NCT02061358|Secondary|CLr by Treatment Group: UV-4|CLr is the renal clearance, calculated at Ae(0-last) divided by AUC(0-last).|Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)|The pharmacokinetic (PK) population consisted of all subjects who received active investigational product, UV-4B, and had at least 1 measured concentration at a scheduled PK time after start of dosing.L/h||L/h||Geometric Coefficient of Variation|Geometric Mean
650145|NCT02061358|Secondary|Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group|fe is the by-interval percentage of UV-4 drug excreted in urine. Intervals were 0 to 6, 6 to 12, 12 to 24, and 24 to 48 hours postdose. fe = Ae/(UV-4B dose x 100). fe(0-12), fe(0-24) and fe(0-last) are the cumulative percentages of UV-4 drug excreted in urine over 24 hours and the entire collection period, respectively.|Pooled urine samples were collected at predose (-12 to 0 hour), and from 0 to 6, 6 to 12, 12 to 24, and 24 to 48 hours postdose|The pharmacokinetic (PK) population consisted of all subjects who received active investigational product, UV-4B, and had at least 1 measured concentration at a scheduled PK time after start of dosing for UV-4B.||percentage of dose||Standard Deviation|Mean
650146|NCT02061358|Secondary|Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group|Ae is the by-interval and cumulative amounts of UV-4 drug excreted in urine. Intervals were 0 to 6, 6 to 12, 12 to 24, and 24 to 48 hours postdose. Ae by-interval amounts were calculated as the product of urine volume and urine concentration. Ae(0-last) is the cumulative amount of UV-4 drug excreted in urine over the entire collection period, 48 hours. Cumulative amounts were calculated as the summation of the amounts excreted in collection intervals.|Pooled urine samples were collected at predose (-12 to 0 hour), and from 0 to 6, 6 to 12, 12 to 24, and 24 to 48 hours postdose|The pharmacokinetic (PK) population consisted of all subjects who received active investigational product, UV-4B, and had at least 1 measured concentration at a scheduled PK time after start of dosing for UV-4B. Subjects in this population were used for all PK summaries.||mg||Standard Deviation|Mean
650147|NCT02061358|Secondary|t(1/2) by Treatment Group: UV-4|t(1/2) is the apparent terminal half-life, determined as ln(2)/λ(z).|Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)|The pharmacokinetic (PK) population consisted of all subjects who received active investigational product, UV-4B, and had at least 1 measured concentration at a scheduled PK time after start of dosing for UV-4B.||hours||Full Range|Median
650148|NCT02061358|Secondary|Vz/F by Treatment Group: UV-4|Vz/F is the apparent volume of distribution of UV-4 based on the terminal phase, calculated as dose (free-base equivalent) divided by [λ(z) × AUC(0-inf)].|Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)|The pharmacokinetic (PK) population consisted of all subjects who received active investigational product, UV-4B, and had at least 1 measured concentration at a scheduled PK time after start of dosing for UV-4B.||L||Geometric Coefficient of Variation|Geometric Mean
650149|NCT02061358|Secondary|CL/F by Treatment Group: UV-4|CL/F is the apparent systematic clearance, calculated as dose (free-base equivalent) divided by AUC(0-inf).|Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)|The pharmacokinetic (PK) population consisted of all subjects who received active investigational product, UV-4B, and had at least 1 measured concentration at a scheduled PK time after start of dosing for UV-4B.||L/h||Geometric Coefficient of Variation|Geometric Mean
650150|NCT02061358|Secondary|AUC(0-inf) by Treatment Group: UV-4|AUC(0-inf) is the area under the concentration-time curve in the sample from pre-dose extrapolated to infinite time, calculated by linear up/log down trapezoidal summation and extrapolated to infinity by addition of the last quantifiable concentration divided by the apparent terminal rate constant: AUC(0-last) - C(last)/λ(z).|Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)|The pharmacokinetic (PK) population consisted of all subjects who received active investigational product, UV-4B, and had at least 1 measured concentration at a scheduled PK time after start of dosing for UV-4B. Subjects in this population were used for all PK summaries.||ng * h/mL||Geometric Coefficient of Variation|Geometric Mean
650151|NCT02061358|Secondary|AUC(0-last) by Treatment Group: UV-4|AUC(0-last) is the area under the concentration-time curve from time zero (pre-dose) to time of last quantifiable concentration, calculated by linear up/log down trapezoidal summation.|Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)|The pharmacokinetic (PK) population consisted of all subjects who received active investigational product, UV-4B, and had at least 1 measured concentration at a scheduled PK time after start of dosing for UV-4B.||ng * h/mL||Geometric Coefficient of Variation|Geometric Mean
650152|NCT02061358|Secondary|Tmax by Treatment Group: UV-4|Tmax is the time of maximum concentration observed directly from the observed concentration versus time data.|Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)|The pharmacokinetic (PK) population consisted of all subjects who received active investigational product, UV-4B, and had at least 1 measured concentration at a scheduled PK time after start of dosing for UV-4B.||hours||Full Range|Median
650153|NCT02061358|Secondary|Cmax by Treatment Group: UV-4|Cmax is the maximum plasma concentration, obtained directly from the observed concentration versus time data.|Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)|The pharmacokinetic (PK) population consisted of all subjects who received active investigational product, UV-4B, and had at least 1 measured concentration at a scheduled PK time after start of dosing for UV-4B.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
650154|NCT02061358|Primary|Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group|Number of subjects with Grade 1 toxicity or higher for hematology, coagulation, chemistry and urinalysis analytes. ULN=upper limit of normal; WBC=white blood cell count.|Day 9 ± 1|Safety Population: all subjects who received any investigational product, UV-4B or placebo||Participants|||Number
650155|NCT02061358|Primary|Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group|Number of subjects in a treatment group with outlier ECG findings: QTcF (Fridericia's), PR, and QRS intervals|From time of the first dose administration through Day 9 ± 1|Safety Population: all subjects who received any investigational product, UV-4B or placebo||participants|||Number
650156|NCT02061358|Primary|Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population)|Number of subjects in a treatment group, who had a vital sign value of toxicity Grade 1 or higher: supine and standing systolic blood pressure (BP), supine and standing diastolic BP, supine and standing pulse rate, respiratory rate, and temperature|From time of the first dose administration through Day 9 ± 1|Safety Population: all subjects who received any investigational product, UV-4B or placebo||Participants|||Number
650157|NCT02061358|Primary|Subjects With Serious Adverse Event (SAEs) by Treatment Group|Subjects with AEs considered serious by the investigator|From time of the first dose administration through Day 9 ± 1|Safety Population: all subjects who received any investigational product, UV-4B or placebo||Subjects with at least 1 SAE|||Number
650158|NCT02061358|Primary|Subjects With Treatment-emergent Adverse Event (TEAEs) by Treatment Group|TEAEs are those AEs occurring only after administration of investigational product|From time of the first dose administration through Day 9 ± 1|Safety Population: all subjects who received any investigational product, UV-4B or placebo||Subjects with at least 1 TEAE|||Number
650159|NCT02060838|Primary|Time to Platelet Aggregation as Measured Using Collagen–Adenosine (ADP)|The membrane of the cartridges are coated with collagen and adenosine diphosphate (ADP) inducing a platelet plug to form which closes the aperture.|Just prior to re-transfusion, assessed up to 5 minutes|||seconds||Inter-Quartile Range|Median
650160|NCT02060838|Primary|Time to Platelet Aggregation as Measured Using Collagen-epinephrine (EPI)|The membrane of the cartridges are coated with collagen and epinephrine (EPI) inducing a platelet plug to form which closes the aperture.|Just prior to re-transfusion, assessed up to 5 minutes|||seconds||Inter-Quartile Range|Median
650161|NCT02060539|Secondary|Average Wearing Time|"Participant response when asked, Number of hours worn today? (hours per day) Obtained at 2 weeks."|2 Weeks|||hours||Standard Deviation|Mean
650162|NCT02060539|Secondary|Average Wearing Time|"Participant response when asked, Number of hours worn today? (hours per day) Obtained for habitual lens at baseline."|Baseline|||hours||Standard Deviation|Mean
650163|NCT02060539|Secondary|Anterior Ocular Physiological Response|Ocular response assessed with the slit lamp using a Visual Analog Scale (0-4, 0=none, 4=severe). Obtained at 2 weeks.|2 Weeks|Overall Conjunctival Staining (n=16), Overall Palpebral Papillae (n=8) Missing data as not all sites collected this data.||units on a scale|Participants|Standard Deviation|Mean
650164|NCT02060539|Secondary|Anterior Ocular Physiological Response|Ocular response assessed with the slit lamp using a Visual Analog Scale (0-4, 0=none, 4=severe). Obtained for habitual lenses at baseline.|Baseline|Overall Conjunctival Staining (n=16), Overall Palpebral Papillae (n=8) Missing data as not all sites collected this data.||units on a scale|Participants|Standard Deviation|Mean
650165|NCT02060539|Secondary|Visual Acuity|Objective measurement by investigator of monocular high and low contrast logMar visual acuity. Visual Acuity High-Contrast (VA HC), Visual Acuity Low-Contrast (VA LC), Visual Acuity High-Contrast OU (VA HC OU), Visual Acuity Low-Contrast OU (VA LC OU). Obtained at 2 weeks.|2 Weeks|||logMar||Standard Deviation|Mean
650166|NCT02060539|Secondary|Visual Acuity|Objective measurement by investigator of monocular high and low contrast logMar visual acuity. Visual Acuity High-Contrast (VA HC), Visual Acuity Low-Contrast (VA LC), Visual Acuity High-Contrast OU (VA HC OU), Visual Acuity Low-Contrast OU (VA LC OU). Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.|Dispense|||logMar||Standard Deviation|Mean
650167|NCT02060539|Secondary|Visual Acuity|Objective measurement by investigator of monocular high and low contrast logMar visual acuity. Visual Acuity High-Contrast (VA HC), Visual Acuity Low-Contrast (VA LC), Visual Acuity High-Contrast OU (VA HC OU), Visual Acuity Low-Contrast OU (VA LC OU). Obtained for habitual lenses at baseline.|Baseline|||logMar||Standard Deviation|Mean
650168|NCT02060539|Secondary|Overall Fit Acceptance|Objective measurement by investigator of overall fit acceptance. (scale 0-4; 0=very poor, 4=very good) Obtained at 2 weeks.|2 Weeks|||units on a scale|Participants|Standard Deviation|Mean
650169|NCT02060539|Secondary|Overall Fit Acceptance|Objective measurement by investigator of overall fit acceptance. (scale 0-4; 0=very poor, 4=very good) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.|Dispense|||units on a scale|Participants|Standard Deviation|Mean
650170|NCT02060539|Secondary|Overall Fit Acceptance|Objective measurement by investigator of overall fit acceptance. (scale 0-4; 0=very poor, 4=very good) Obtained for habitual lenses at baseline.|Baseline|||units on a scale|Participants|Standard Deviation|Mean
650171|NCT02060539|Secondary|Lens Movement|Objective measurement by investigator of overall post-blink lens movement. (Average Grade; Graded 0-4; 0=exceptionally tight, 2=optimal, 4=exceptionally loose) Obtained at 2 weeks wear.|2 Weeks|||units on a scale|Participants|Standard Deviation|Mean
650172|NCT02060539|Secondary|Lens Movement|Objective measurement by investigator of overall post-blink lens movement. (Average Grade; Graded 0-4; 0=exceptionally tight, 2=optimal, 4=exceptionally loose) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.|Dispense|||units on a scale|Participants|Standard Deviation|Mean
650173|NCT02060539|Secondary|Lens Movement - Habitual Lenses|Objective measurement by investigator of overall post-blink lens movement. (Average Grade; Graded 0-4; 0=exceptionally tight, 2=optimal, 4=exceptionally loose) Obtained for habitual lenses at baseline.|Baseline|||units on a scale|Participants|Standard Deviation|Mean
650174|NCT02060539|Secondary|Lens Centration|Objective measurement by investigator. (Assessed as optimum, slightly decentered, extremely decentered) Obtained at 2 weeks.|2 Weeks|||percentage of lenses|Participants||Number
650175|NCT02060539|Secondary|Lens Centration|Objective measurement by investigator. (Assessed as optimum, slightly decentered, extremely decentered) Obtained at baseline at dispense.|Dispense|||percentage of lenses|Participants||Number
650176|NCT02060539|Primary|Overall Preference|Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at 2 weeks.|2 Weeks|||percentage of participants|||Number
650177|NCT02060539|Primary|Overall Preference|Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.|Dispense|||percentage of participants|||Number
650178|NCT02060539|Primary|Handling Preference|Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at 2 weeks.|2 Weeks|||percentage of participants|||Number
650179|NCT02060539|Primary|Vision Preference|Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at 2 weeks.|2 Weeks|||percentage of participants|||Number
650180|NCT02060539|Primary|Vision Preference|Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.|Dispense|||percentage of participants|||Number
650181|NCT02060539|Primary|Comfort Preference|Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at 2 weeks.|2 Weeks|||percentage of participants|||Number
650182|NCT02060539|Primary|Comfort Preference|Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.|Dispense|||percentage of participants|||Number
650183|NCT02060539|Primary|Overall Satisfaction of Comfort, Vision, Handling|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely dissatisfied; 100=Extremely satisfied.) Obtained at baseline at 2 weeks.|2 Weeks|||units on a scale||Standard Deviation|Mean
650184|NCT02060539|Primary|Overall Satisfaction of Comfort, Vision, Handling|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely dissatisfied; 100=Extremely satisfied.) Obtained habitual lens history at baseline.|Baseline|||units on a scale||Standard Deviation|Mean
650185|NCT02060539|Primary|Overall Satisfaction of Comfort, Vision, Handling|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely dissatisfied; 100=Extremely satisfied.) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.|Dispense|||units on a scale||Standard Deviation|Mean
650186|NCT02060539|Primary|Handling (Insertion, Removal, Overall)|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained at 2 weeks.|2 weeks|||units on a scale||Standard Deviation|Mean
650187|NCT02060539|Primary|Handling (Insertion, Removal, Overall)|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained habitual lens history at baseline.|Baseline|||units on a scale||Standard Deviation|Mean
650188|NCT02060539|Primary|Vision Quality (During Day and at Night)|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely poor vision all the time. Cannot function; 100=Excellent vision all of the time.) Obtained at 2 weeks.|2 Weeks|||units on a scale||Standard Deviation|Mean
650189|NCT02060539|Primary|Vision Quality (During Day)|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely poor vision all the time. Cannot function; 100=Excellent vision all of the time.) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.|Dispense|||units on a scale||Standard Deviation|Mean
650190|NCT02060539|Primary|Vision Quality (During Day and at Night)|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely poor vision all the time. Cannot function; 100=Excellent vision all of the time.) Obtained habitual lens history at baseline.|Baseline|||units on a scale||Standard Deviation|Mean
650191|NCT02060539|Primary|Hazing (Blurred Edges)|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreme haze. Cannot be worn. 100=No hazing experienced at any time.) Obtained at 2 weeks.|2 Weeks|||units on a scale||Standard Deviation|Mean
650192|NCT02060539|Primary|Hazing (Blurred Edges)|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreame haze. Cannot be worn. 100=No hazing experienced at any time.) Obtained habitual lens history at baseline.|Baseline|||units on a scale||Standard Deviation|Mean
650193|NCT02060539|Primary|Ghosting (Multiple Images)|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreme ghosting. Cannot be worn. 100=No ghosting ever.) Obtained at 2 weeks.|2 Weeks|||units on a scale||Standard Deviation|Mean
650194|NCT02060539|Primary|Ghosting (Multiple Images)|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreme ghosting. Cannot be worn. 100=No ghosting ever.) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.|Dispense|||units on a scale||Standard Deviation|Mean
650195|NCT02060539|Primary|Ghosting (Multiple Images)|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreame ghosting. Cannot be worn. 100=No ghosting ever.) Obtained habitual lens history at baseline.|Baseline|||units on a scale||Standard Deviation|Mean
650196|NCT02060539|Primary|Comfort (Insertion, End of Day, Overall)|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained at 2 weeks.|2 Weeks|||units on a scale||Standard Deviation|Mean
650197|NCT02060539|Primary|Comfort (Insertion)|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.|Dispense|||units on a scale||Standard Deviation|Mean
650198|NCT02060539|Primary|Comfort (Insertion, End of Day, Overall)|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained habitual lens history at baseline.|Baseline|||units on a scale||Standard Deviation|Mean
650199|NCT02060539|Primary|Dryness (During Day and Dryness at Night)|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn, Extremely dry. 100=No dryness experienced at any time.) Obtained at two weeks.|2 Weeks|||units on a scale||Standard Deviation|Mean
650200|NCT02060539|Primary|Dryness (During Day)|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn, Extremely dry. 100=No dryness experienced at any time.) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.|Dispense|||units on a scale||Standard Deviation|Mean
650201|NCT02060539|Secondary|Lens Centration - Habitual Lenses|Objective measurement by investigator. (Assessed as optimum, slightly decentered, extremely decentered) Obtained for habitual lenses at baseline.|Baseline|||percentage of lenses|Participants||Number
650202|NCT02060539|Primary|Dryness (During Day and Dryness at Night)|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn, Extremely dry. 100=No dryness experienced at any time.) Obtained habitual lens history at baseline.|Baseline|||units on a scale||Standard Deviation|Mean
650203|NCT02060526|Secondary|Maximum Observed Drug Concentration (Cmax) of Recombinant Human Heparan-N-Sulfatase (rhHNS) in Serum|Cmax of rhHNS in serum was evaluated using enzyme-linked immunosorbent assay (ELISA) method and liquid chromatography tandem mass spectrometry (LC-MS) method.|Predose, 0.5 h, 1 h, 2 h, 4 h, 8 h, 12 h, 24 h, and 48 h post-dose on Week 0 and Week 48|Pharmacokinetic (PK) population included all participants who received HGT-1410, participated in the scheduled PK studies, and had sufficient samples available for analysis.||ng/ml||Standard Deviation|Mean
650204|NCT02060526|Secondary|Concentration of Recombinant Human Heparan-N-Sulfatase (rhHNS) in Cerebrospinal Fluid (CSF)|Concentration of rhHNS in CSF was assessed using validated enzyme-linked immunosorbent assay (ELISA) method.|Pre-dose, 4, 48 hours on Week 0 and Week 48|Pharmacokinetic (PK) population included all participants who received HGT-1410, participated in the scheduled PK studies, and had sufficient samples available for analysis.||nanogram per milliliter (ng/ml)||Standard Deviation|Mean
650205|NCT02060526|Secondary|Change From Baseline in Concentration of GAG in Urine at Week 48|The concentration of GAG in urine was normalized to the urine creatinine value and reported as milligram (mg) GAG per millimole (mmol) creatinine.|Baseline (Week 0), Week 48|ITT population included all randomized participants.||mg GAG/mmol creatinine||Standard Deviation|Mean
650206|NCT02060526|Secondary|Change From Baseline in Concentration of Glycosaminoglycan (GAG) in Cerebrospinal Fluid (CSF) at Week 48|Change from baseline in concentration of GAG in CSF at Week 48 was reported.|Baseline (Week 0), Week 48|ITT population included all randomized participants.||micromolar||Standard Deviation|Mean
650207|NCT02060526|Secondary|Change From Baseline in Total Cortical Grey Matter Volume at Week 48|The change from baseline in grey matter volume at Week 48 was assessed by magnetic resonance imaging (MRI).|Baseline (Week 0), Week 48|ITT population included all randomized participants.||cubic centimeter (cc)||Standard Deviation|Mean
650208|NCT02060526|Secondary|Change From Baseline in Development Quotient (DQ) Using Bayley Scales of Infant Development Assessment Third Edition (BSID-III) at Week 48|The BSID-­III is a series of measurements to assess the motor (fine and gross), language (receptive and expressive), and cognitive development of infants and toddlers and consists of a series of developmental play tasks. The DQ is a means to express a neurodevelopmental/cognitive delay which was computed as a ratio and expressed as a percentage using the age-equivalent score divided by the age at testing ([age-equivalent score/chronological age] × 100; range: 0, 100). The BSID-­III DQ score is based on the cognitive domain. A positive value indicates improvement in health and cognition.|Baseline (Week 0), Week 48|ITT population included all randomized participants.||percentage of chronological age||Standard Deviation|Mean
650209|NCT02060526|Secondary|Change From Baseline in Vineland Adaptive Behavior Scales Second Edition (VABS-II) Development Quotient (DQ) Score at Week 48|The VABS-II test measures adaptive behaviors, including the ability to cope with environmental changes, to learn new everyday skills, and to demonstrate independence. The DQ is a means to express a neurodevelopmental/cognitive delay. The DQ was computed as a ratio and expressed as a percentage using the age-equivalent score divided by the age at testing ([age-equivalent score/chronological age] × 100; range, 0, 100). The overall DQ score is calculated from the mean age-equivalent score obtained by averaging out the age-equivalent scores for the all the sub-domains except for Gross and Fine motor skills. This test measures the following 5 key domains: communication, daily living skills, socialization, motor skills, and the adaptive behavior composite (a composite of the other 4 domains). A positive value indicates improvement in health and cognition.|Baseline (Week 0), Week 48|ITT population included all randomized participants.||percentage of chronological age||Standard Deviation|Mean
650210|NCT02060526|Secondary|Number of Participants With Positive Anti-recombinant Human Heparan-N-Sulfatase (rhHNS) Antibody in Serum at Week 48|A participant was considered positive if they had at least 1 positive result during the study. Once a participant reported antibody positive, they were considered positive for the remainder of the study.|Baseline (Week 0) up to Week 48|Safety population included all participants who received a dose of HGT-1410 using either the IDDD implantation or LP; underwent the IDDD surgical implant procedure without receiving a dose of HGT-1410; were randomly assigned to the untreated group and had any safety followup data.||participants|||Number
650211|NCT02060526|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs)|An adverse event (AE) was any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in any phase of a clinical study, whether or not considered investigational product related. This included an exacerbation of a pre-existing condition. TEAEs were defined as AE occurring on or after the time of first IDDD implantation or LP procedure to the end of study (EOS) visit (+30 days).|Baseline (Week 0) up to Week 52|Safety population included all participants who received a dose of HGT-1410 using the IDDD implantation or LP; underwent the IDDD surgical implant procedure without receiving a dose of HGT-1410; were randomly assigned to the untreated group and had any safety follow-up data.||participants|||Number
650225|NCT02059291|Primary|Percentage of Participants With Resolution of Initial Flare and Absence of New Flares up to the End of the Randomized Treatment Epoch (16weeks)|Resolution of the initial disease flare is defined as: Physical Global Assessment of Disease activity (PGA) <2 and C-reactive protein (CRP) within normal range (<= 10 mg/L) or reduction by at least 70% from baseline. The PGA was evaluated by the investigator based on a 5-point scale: 0 = None (no) disease associated with clinical signs and symptoms; 1 = minimal disease associated signs and symptoms; 2 = mild disease associated signs and symptoms; 3 = moderate disease associated signs and symptoms; and 5 = severe disease associated signs and symptoms.|16 weeks|The Full Analysis Set (FAS), which consisted of all randomized participants in the randomized treatment epoch who received at least one dose of study drug in Epoch 2, was analyzed.||Percentage of participants|||Number
650212|NCT02060526|Secondary|Number of Participants With Serious Adverse Events (SAE)|An adverse event (AE) was any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in any phase of a clinical study, whether or not considered investigational product related. This included an exacerbation of a pre-existing condition. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline (Week 0) up to Week 52|Safety population included all participants who received a dose of HGT-1410 either using IDDD implantation or LP; underwent the IDDD surgical implant procedure without receiving a dose of HGT-1410; were randomly assigned to the untreated group and had any safety follow-up data.||participants|||Number
650213|NCT02060526|Primary|Number of Participants With Overall Response Using Bayley Scales of Infant Development Assessment Third Edition (BSID-III)|The BSID-­III is a series of measurements to assess the motor (fine and gross), language (receptive and expressive), and cognitive development of infants and toddlers and consists of a series of developmental play tasks. The development quotient (DQ) is a means to express a neurodevelopmental/cognitive delay which was computed as a ratio and expressed as a percentage using the age equivalent score divided by the age at testing ([age-equivalent score/chronological age] × 100; range: 0, 100). The BSID-­III DQ score is based on the cognitive domain. A positive value indicates improvement in health and cognition. Overall response was the maximum decline in the DQ of 10 points or less over 48 weeks. Number of participants with the overall response were reported here.|Baseline (Week 0) up to Week 48|ITT population included all randomized participants.||participants|||Number
650214|NCT02059993|Primary|Change of Daytime Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Pre-treatment and Post-treatment||baseline and follow-up at 36 months|4 participants withdrew before the end of study. Two subjects were lost to follow-up in the control group, and 4 patients (all of them had no SCCE) with very poor CPAP compliance were also excluded.||mm Hg||Standard Deviation|Mean
650215|NCT02059993|Other Pre-specified|Cardiovascular and Cerebrovascular Events||Baseline, 1 month, 3 month, 6 month, 12 month, 18 month, 24 month, 30 month, 36 month||||||
650216|NCT02059993|Secondary|Change in Epworth Sleepiness Scale (ESS)||1 month，3 month，6 month，12 month，18 month，24 month，30 month，36 month||||||
650217|NCT02059993|Secondary|Change in Glucose and Lipid Metabolism||Baseline, 1 month, 3 month, 6 month, 12 month, 18 month, 24 month, 30 month, 36 month||||||
650218|NCT02059928|Primary|Standardized Ratio as a Percentage Between Mean IOP and Mean Arterial Pressure|External cuff pressure readings were recorded every 15 minutes, and IO pressure data obtained via pressure transducer was recorded continuously for up to 12 hours. IO systolic, diastolic, and mean pressure (IO SBP, IO DBP, IO Mean) readings were summarized for the minute before and minute following an external cuff pressure reading. The ratios as a percentage of IO pressures to external cuff pressures (IO Systolic Blood Pressure / Cuff SBP; IO DBP / Cuff DBP; IO Mean / Cuff Mean) were calculated.|Up to 12 hour data collection period|Inclusion criteria included: age ≥ 18 year old, presence of an IO placed by EMS or in the Emergency Department, and planned admission to the Medical or Surgical Intensive Care Unit. Patients were excluded if they had anticipated surgery within 12 hours of IO placement, ongoing infection at the placement site.||percentage of IO pressure to cuff pressu|||Number
650219|NCT02059902|Primary|Narcotic Consumption (Measured in mg/kg Narcotic Consumption)|The infusion was initiated at 1.5mg/kg for 30 minutes prior to surgery start, followed by a 2.0 mg/kg/hr infusion at the time of incision start. The rate was reduced to 1.5mg/kg/hr for the remainder of the 24 hour period. A standardized post-operative pain management strategy (morphine and oxycodone) was followed by clinical staff, based on a standardized pain scale rating tool. The difference in narcotic consumption and number of pain medication doses over the 72-hour post-operative period was compared using an unadjusted Wilcoxon rank sum test due to non-normal data distribution.|24-hours post surgery|||mg/kg narcotic consumption||Inter-Quartile Range|Median
650220|NCT02059642|Secondary|Safety Evaluation of Treatment on the Basis of Percentage of Participants With Treatment Emergent Adverse Events|Safety assessments will be based on changes from Baseline of clinical AEs reported by the subject or observed by the Investigator and concomitant medication use, treatment adherence (eg, dropouts due to AEs)|6 weeks|Safety population||Percentage of participants with TEAEs|||Number
650221|NCT02059642|Primary|Change in Total ADHD Symptom Score With Adult Prompts of the Conners Adult ADHD Rating Scale:O-SV in ADHD Adults From Baseline to 6 Weeks|Primary efficacy endpoint: change from Baseline in the total ADHD symptom score with adult prompts of the CAARS-Inv. The CAARS is a scale to assess the presence and severity of ADHD symptoms and behaviors in adults. During an interview with the investigator, subject rates items pertaining to their behavior using a 4-point Likert-style format ranging from 0 (‘Not at all’) to 3 (‘Very much). The scale measures ADHD symptoms across clinically significant domains using a 30 item questionnaire, while examining the manifestations of those symptoms. The scale includes an assessment of 9 inattentive symptoms (Subset A) and 9 hyperactive & impulsive symptoms (Subset B). The total ADHD symptom score, Subset C (the sum of the inattentive symptom scores from Subset A and the hyperactive & impulsive symptoms from Subset B) is the primary outcome measure. Scores of the scale for Subset C, comprised of scores from 18 questions,range from 0 (no ADHD symptoms) to 54, highest rating of ADHD symptoms.|baseline, 6 weeks|Intent to Treat||Change in Score from Baseline||95% Confidence Interval|Least Squares Mean
650222|NCT02059291|Secondary|Percentage of Participants With Normalized Serum Amyloid A (SAA) Level|Normalized SAA was defined as SAA <= 10 mg/L.|16 weeks||06/2018||||
650223|NCT02059291|Secondary|Percentage of Participants With the Serologic Remission|Serologic remission was defined as C-reactive protein <= 10 mg/L.|16 weeks||06/2018||||
650224|NCT02059291|Secondary|Percentage of Participants Who Achieve Physician's Global Assessment < 2|The PGA was evaluated by the investigator based on a 5-point scale: 0 = None (no) disease associated with clinical signs and symptoms; 1 = minimal disease associated signs and symptoms; 2 = mild disease associated signs and symptoms; 3 = moderate disease associated signs and symptoms; and 5 = severe disease associated signs and symptoms.|16 weeks||06/2018||||
650226|NCT02059187|Secondary|Percentage of Participants With Hemoglobin A1C <6.5% at Week 24|Percentage of participants with A1C <6.5% (48 mmol/mol) at Week 24.|Week 24|The analysis population included all randomized, treated participants with a Week 24 A1C measurement.||Percentage of participants|||Number
650228|NCT02059187|Secondary|Change From Baseline in Participant 7-Point Average of Self-Monitored Blood Glucose (SMBG) at Week 24|7-Point Average of SMBG was defined as the mean of blood glucose measurements taken at the following 7 times: before morning meal, after morning meal, before midday meal, after midday meal, before evening meal, after evening meal or at bedtime, and between 2 AM and 4 AM.|Baseline and Week 24|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.||mg/dL||95% Confidence Interval|Least Squares Mean
650229|NCT02059187|Secondary|Change From Baseline in Participant Fasting Plasma Glucose (FPG) at Week 24|Participants fasted (no food or drink except water and non-antihyperglycemic non-study medications as prescribed) for at least 8 hours prior to all study visits.|Baseline and Week 24|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.||mg/dL||95% Confidence Interval|Least Squares Mean
650230|NCT02059187|Secondary|Daily Basal Insulin Dose Per Body Weight (Units/kg) at Week 24|Basal insulin dose per body weight was calculated as total insulin dose (units) per day divided by body weight in kilograms (kg).|Week 24|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.||Units/kg||95% Confidence Interval|Least Squares Mean
650231|NCT02059187|Secondary|Daily Basal Insulin Dose (Units) at Week 24|The daily basal insulin dose (measured in units) for any given visit is defined as the average dose from the three most recent days preceding the visit date.|Week 24|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.||Units||95% Confidence Interval|Least Squares Mean
650232|NCT02059187|Secondary|Percentage of Participants Experiencing an AE Over the 24-week Treatment Period|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the investigational product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the investigational product, is also an AE.|Up to 24 weeks|All randomized participants who received at least one dose of study treatment.||Percentage of participants|||Number
650233|NCT02059187|Secondary|Percentage of Participants Experiencing an Adverse Event (AE) of Hypoglycemia Up to Week 24|Symptomatic events assessed as likely to be hypoglycemia were to be reported by investigators as adverse events of hypoglycemia; a concurrent glucose measurement was not required. Asymptomatic events with confirmed glucose levels </= 70mg/dL (</= 3.9mmol/L) could also be reported as adverse events at the discretion of the investigator.|Up to 24 weeks|All randomized participants who received at least one dose of study treatment.||Percentage of participants|||Number
650234|NCT02059187|Secondary|Change From Baseline in Participant Body Weight at Week 24|Change from baseline in participant body weight at Week 24.|Baseline and Week 24|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.||kilograms||Standard Deviation|Mean
650235|NCT02059187|Primary|Percentage of Participants With Confirmed Anti-Insulin Antibodies (AIA) up to Week 24|Percentage of participants is a cumulative percentage of participants with any confirmed AIA (including baseline) up to Week 24.|Up to 24 weeks|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.||Percentage of participants|||Number
650236|NCT02059187|Primary|Change From Baseline in Participant Hemoglobin A1C Level at Week 24|A1C is measured as a percent. A1C is the key glycemic parameter which correlates with reduction of risk of diabetic complications.|Baseline and Week 24|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.||Percent A1C||95% Confidence Interval|Least Squares Mean
650237|NCT02059174|Secondary|M1 Glargine Metabolite PK: Area Under the Plasma Concentration Versus Time Curve Over the Second 12 Hours After Dosing (AUC12-24)|M1 glargine is the dominant circulating glargine-derived insulin metabolite after subcutaneous injection and it is pharmacologically active. AUC12-24 is a measure of the total amount of drug in the plasma from Hour 12 to Hour 24. Analysis was performed on log scale with results back transformed to original scale.|From 12 to 24 hours postdose|The Per-Protocol population consists of 75 participants, including the 70 with complete data across all 4 treatment periods and 5 participants with partial data. One participant was not included in the PP population due to a medical issue. All available data from 5 of the participants who discontinued the study were included in the analyses.||pg∙hr/mL||95% Confidence Interval|Geometric Mean
650238|NCT02059174|Secondary|M1 Glargine Metabolite PK: Area Under the Plasma Concentration Versus Time Curve Over the First 12 Hours After Dosing (AUC0-12)|M1 glargine is the dominant circulating glargine-derived insulin metabolite after subcutaneous injection and it is pharmacologically active. AUC0-12 is a measure of the total amount of drug in the plasma from the dose to Hour 12. Analysis was performed on log scale with results back transformed to original scale.|Up to 12 hours postdose|The Per-Protocol population consists of 75 participants, including the 70 with complete data across all 4 treatment periods and 5 participants with partial data. One participant was not included in the PP population due to a medical issue. All available data from 5 of the participants who discontinued the study were included in the analyses.||pg∙hr/mL||95% Confidence Interval|Geometric Mean
650239|NCT02059174|Primary|M1 Glargine Metabolite PK: Maximum Plasma Concentration (Cmax)|M1 glargine is the dominant circulating glargine-derived insulin metabolite after subcutaneous injection and it is pharmacologically active. Cmax is a measure of the maximum amount of drug in the plasma after the dose is given. Analysis was performed on log scale with results back transformed to original scale.|Up to 24 hours postdose|The Per-Protocol population consists of 75 participants, including the 70 with complete data across all 4 treatment periods and 5 participants with partial data. One participant was not included in the PP population due to a medical issue. All available data from 5 of the participants who discontinued the study were included in the analyses.||pg/mL||95% Confidence Interval|Geometric Mean
650254|NCT02059161|Secondary|Percentage of Participants Attaining A1C Glycemic Goals of <7% and <6.5% After 52 Weeks of Treatment.|Percentage of participants attaining A1C glycemic goals of <7.0% and <6.5% after 52 weeks of treatment.|52 weeks|The analysis population included all randomized, treated participants with a Week 52 A1C measurement.||Percentage of participants|||Number
651413|NCT02029521|Primary|BMI Percentile|Body Mass Index percentile adjusted for sex and age. Standard BMI are not available for participants under 2 years of age|3 months|BMI percentile not available for children under 2 years of age.||Percentile adjusted for age and sex||Standard Deviation|Mean
650240|NCT02059174|Primary|M1 Glargine Metabolite Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve (AUC0-24)|M1 glargine is the dominant circulating glargine-derived insulin metabolite after subcutaneous injection and it is pharmacologically active. AUC0-24 is a measure of the total amount of drug in the plasma from the dose to Hour 24. Analysis was performed on log scale with results back transformed to the original scale|Up to 24 hours postdose|The Per-Protocol population consists of 75 participants, including the 70 with complete data across all 4 treatment periods and 5 participants with partial data. One participant was not included in the PP population due to a medical issue. All available data from 5 of the participants who discontinued the study were included in the analyses.||pg∙hr/mL||95% Confidence Interval|Geometric Mean
650241|NCT02059174|Primary|PD: Maximum Glucose Infusion Rate (GIRmax)|Maximum glucose infusion rate (GIR[max]) based on smoothed data for participants who received either MK-1293 or EU-Lantus™ administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design was measured from blood samples obtained during a euglycemic clamp procedure.|Up to 30 hours postdose|The Per-Protocol population included 70 participants with complete data and 5 participants with partial data. One participant was not included in the PP population due to a medical issue. Data from 5 discontinued participants were included in the analyses; data from 1 participant was not (incomplete clamp data, only out to 18.5 hours).||mg/kg/min||95% Confidence Interval|Mean
650242|NCT02059174|Primary|PD: Area Under the Glucose Infusion Rate Versus Time Curve Over the Second 12 Hours After Dosing (GIR-AUC12-24hr)|The area under the glucose infusion rate curve from hours 12 to 24 after injection (AUC[GIR{12-24}]) for participants who received either MK-1293 or Lantus™ administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design was measured from blood samples obtained during a euglycemic clamp procedure.|From 12 to 24 hours postdose|The Per-Protocol population included 70 participants with complete data and 5 participants with partial data. One participant was not included in the PP population due to a medical issue. Data from 5 discontinued participants were included in the analyses; data from 1 participant was not (incomplete clamp data, only out to 18.5 hours).||mg/kg||95% Confidence Interval|Mean
650243|NCT02059174|Primary|PD: Area Under the Glucose Infusion Rate Versus Time Curve Over the First 12 Hours After Dosing (GIR-AUC0-12hr)|The area under the glucose infusion rate curve from hours 0 to 12 after injection (AUC[GIR{0-12}]) for participants who received either MK-1293 or EU-Lantus™ administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design was measured from blood samples obtained during a euglycemic clamp procedure.|Up to 12 hours postdose|The Per-Protocol population consists of 75 participants, including the 70 with complete data across all 4 treatment periods and 5 participants with partial data. One participant was not included in the PP population due to a medical issue. All available data from 5 of the participants who discontinued the study were included in the analyses.||mg/kg||95% Confidence Interval|Mean
650244|NCT02059174|Primary|PD: Area Under the Glucose Infusion Rate Versus Time Curve Over 24 Hours After Dosing (GIR-AUC0-24hr)|The area under the glucose infusion rate curve from hours 0 to 24 after injection (AUC[GIR{0-24}]) for participants who received either MK-1293 or EU-Lantus™ administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design was measured from blood samples obtained during a euglycemic clamp procedure.|Up to 24 hours postdose|The Per-Protocol population included 70 participants with complete data and 5 participants with partial data. One participant was not included in the PP population due to a medical issue. Data from 5 discontinued participants were included in the analyses; data from 1 participant was not (incomplete clamp data, only out to 18.5 hours).||mg/kg||95% Confidence Interval|Mean
650245|NCT02059174|Primary|Comparison of MK-1293 and EU-Approved Lantus Duration of Pharmacodynamic Action During a 30-Hour Euglycemic Clamp Study|Duration of Action (DOA) is defined as the length of time from dosing to End of Action. End of Action is defined as the time point at which plasma glucose has been above 150 mg/dL for 30 minutes and no glucose has been infused for 30 minutes. Median and max below are reported for the length of clamp duration (i.e. 30 hours).|Up to 30 hours postdose|The Per-Protocol population consists of 75 participants, including the 70 with complete data across all 4 treatment periods and 5 participants with partial data. One participant was not included in the PP population due to a medical issue. All available data from 5 of the participants who discontinued the study were included in the analyses.||Hours||Full Range|Median
650246|NCT02059161|Secondary|Bolus Insulin Dose Per kg of Body Weight at Week 24|Bolus Insulin Dose per kg of Body Weight at Week 24.|Week 24|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.||Units/kg||95% Confidence Interval|Least Squares Mean
650247|NCT02059161|Secondary|Bolus Insulin Dose at Week 24|Bolus Insulin Dose at Week 24.|Week 24|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.||Units||95% Confidence Interval|Least Squares Mean
650248|NCT02059161|Secondary|Basal Insulin Dose Per kg of Body Weight at Week 24|Basal Insulin Dose per kg of Body Weight at Week 24.|Week 24|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.||Units/kg||95% Confidence Interval|Least Squares Mean
650249|NCT02059161|Secondary|Basal Insulin Dose at Week 24|Basal Insulin Dose at Week 24.|Week 24|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.||Units||95% Confidence Interval|Least Squares Mean
650250|NCT02059161|Secondary|Bolus Insulin Dose Per kg of Body Weight at Week 52|Bolus Insulin Dose per kg of Body Weight at Week 52.|Week 52|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.||Units/kg||95% Confidence Interval|Least Squares Mean
650251|NCT02059161|Secondary|Bolus Insulin Dose at Week 52|Bolus Insulin Dose at Week 52.|Week 52|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.||Units||95% Confidence Interval|Least Squares Mean
650252|NCT02059161|Secondary|Basal Insulin Dose Per kg of Body Weight at Week 52|Basal Insulin Dose per kg of Body Weight at Week 52.|Week 52|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.||Units/kg||95% Confidence Interval|Least Squares Mean
650253|NCT02059161|Secondary|Basal Insulin Dose at Week 52|Basal Insulin Dose at Week 52.|Week 52|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.||Units||95% Confidence Interval|Least Squares Mean
650255|NCT02059161|Secondary|Percentage of Participants Attaining A1C Glycemic Goals of <7% and <6.5% After 24 Weeks of Treatment.|Percentage of participants attaining A1C glycemic goals of <7.0% and <6.5% after 24 weeks of treatment.|24 weeks|The analysis population included all randomized, treated participants with a Week 24 A1C measurement.||Percentage of participants|||Number
650256|NCT02059161|Secondary|Change From Baseline in 7-point SMBG at Week 52|The 7-point SMBG profile consisted of the following measurements by glucose meter: morning pre-meal (fasting), 2 hours after morning meal, midday pre-meal, 2 hours after midday meal, evening pre meal, pre-bedtime (pre-dose and at least 2 hours after evening meal), between 2:00 AM and 4:00 AM in the morning.|Baseline and Week 52|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.||mg/dL||95% Confidence Interval|Least Squares Mean
650257|NCT02059161|Secondary|Change From Baseline in 7-point Self-monitored Blood Glucose (SMBG) at Week 24|The 7-point SMBG profile consisted of the following measurements by glucose meter: morning pre-meal (fasting), 2 hours after morning meal, midday pre-meal, 2 hours after midday meal, evening pre meal, pre-bedtime (pre-dose and at least 2 hours after evening meal), between 2:00 AM and 4:00 AM in the morning.|Baseline and Week 24|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.||mg/dL||95% Confidence Interval|Least Squares Mean
650258|NCT02059161|Secondary|Percentage of Participants Who Develop Insulin Neutralizing Antibodies Up Through Week 52|Percentage of Participants Who Develop Insulin Neutralizing Antibodies Up Thought Week 52. This immunogenicity analysis assessed the effect of treatment with MK-1293 and with Lantus on insulin-neutralizing antibody (INAb) development up through 52 weeks of treatment.|Up to Week 52|The analysis population included all randomized, treated participants who were INAb negative at baseline and who had data for INAb at or before Week 52.||Percentage of participants|||Number
650259|NCT02059161|Secondary|Change From Baseline in FPG at Week 52|Blood glucose was measured on a fasting basis (collected after a 10-hour fast). This change from baseline reflects the FPG level at Week 52 minus the FPG level at Week 0.|Baseline and Week 52|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.||mg/dL||95% Confidence Interval|Least Squares Mean
650260|NCT02059161|Secondary|Total Insulin Dose Per Kilogram (kg) of Body Weight (Unit/kg) at Week 52|Total insulin dose = basal insulin (MK-1293 or Lantus) + bolus (prandial) insulin (non-study medication).|Week 52|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.||Insulin units/kg.||95% Confidence Interval|Least Squares Mean
650261|NCT02059161|Secondary|Total Insulin Dose at Week 52|Total insulin dose = basal insulin (MK-1293 or Lantus) + bolus (prandial) insulin (non-study medication).|Week 52|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.||Insulin units||95% Confidence Interval|Least Squares Mean
650262|NCT02059161|Secondary|Change From Baseline in AIA Titer After 52 Weeks of Treatment|This immunogenicity analysis assessed the effect of treatment with MK-1293 compared with Lantus on anti-insulin antibody development after 52 weeks of treatment. This change from baseline reflects the AIA titers at Week 52 minus the AIA titers at Week 0.|Baseline and Week 52|The analysis population included all randomized, treated participants who had AIA data at baseline and Week 52.||AIA Titers||Standard Deviation|Mean
650263|NCT02059161|Secondary|Percentage of Participants With Negative AIA at Baseline Who Develop Confirmed Positive AIA at Any Time Up Through Week 52|Percentage of participants who became positive to AIA at or before Week 52, among participants who were AIA negative at baseline.|Up to Week 52|The analysis population included all randomized, treated participants who had data for AIA at baseline and Week 52.||Percentage of participants|||Number
650264|NCT02059161|Secondary|Percentage of Participants With Confirmed Positive AIA Up Through Week 52|Percentage of participants with confirmed positive AIA at any time up through Week 52 including baseline.|Up to Week 52 including baseline|The analysis population included all randomized, treated participants who had data for AIA at or before Week 52.||Percentage of participants|||Number
650265|NCT02059161|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Blood glucose was measured on a fasting basis (collected after a 10-hour fast). FPG is expressed as mg/dL. This change from baseline reflects the FPG level at Week 24 minus the FPG level at Week 0.|Baseline and Week 24|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.||mg/dL||95% Confidence Interval|Least Squares Mean
650266|NCT02059161|Secondary|Total Insulin Dose Per Kilogram (kg) of Body Weight (Unit/kg) at Week 24|Total insulin dose = basal insulin (MK-1293 or Lantus) + bolus (prandial) insulin (non-study medication).|Week 24|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.||Insulin units/kg.||95% Confidence Interval|Least Squares Mean
650267|NCT02059161|Secondary|Total Insulin Dose at Week 24|Total insulin dose = basal insulin (MK-1293 or Lantus) + bolus (prandial) insulin (non-study medication).|Week 24|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.||Insulin units||95% Confidence Interval|Least Squares Mean
650268|NCT02059161|Secondary|Change From Baseline in A1C at Week 52|A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 52 A1C minus the Week 0 A1C.|Baseline and Week 52|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.||Percent||95% Confidence Interval|Least Squares Mean
650269|NCT02059161|Primary|Percentage of Participants Who Develop Insulin Neutralizing Antibodies Up Through Week 24|Percentage of Participants Who Develop Insulin Neutralizing Antibodies Up Through Week 24. This immunogenicity analysis assessed the effect of treatment with MK-1293 and with Lantus on insulin-neutralizing antibody (INab) development up through 24 weeks of treatment.|Up to Week 24|The analysis population included all randomized, treated participants who were INAb negative at baseline and who had data for INAb at or before Week 24.||Percentage of participants|||Number
650270|NCT02059161|Primary|Change From Baseline in AIA Titer After 24 Weeks of Treatment|This immunogenicity analysis will assess the effect of treatment with MK-1293 compared with Lantus on anti-insulin antibody development after 24 weeks of treatment. This change from baseline reflects the Week 24 AIA titer minus the Week 0 AIA titer.|Baseline and Week 24|The analysis population included all randomized, treated participants who had AIA data at baseline and Week 24.||AIA Titers||Standard Deviation|Mean
650271|NCT02059161|Primary|Percentage of Participants With Negative AIA at Baseline Who Develop Confirmed Positive AIA at Any Time Up Through Week 24|Percentage of participants who became positive to AIA at or before Week 24, among participants who were AIA negative at baseline.|Up to Week 24|The analysis population included all randomized, treated participants who were AIA negative at baseline and had data for AIA at or before Week 24.||Percentage of participants|||Number
650272|NCT02059161|Primary|Percentage of Participants With Any Confirmed Positive Anti-insulin Antibody (AIA) at Any Time Up Through Week 24|Percentage of participants with confirmed positive AIA at any time up through Week 24 including baseline.|Up to Week 24|The analysis population included all randomized, treated participants who had data for AIA at or before Week 24.||Percentage of participants|||Number
650273|NCT02059161|Primary|Primary: Change From Baseline in Hemoglobin A1c (A1C) at Week 24|A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 24 A1C minus the Week 0 A1C.|Baseline and Week 24|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.||Percent||95% Confidence Interval|Least Squares Mean
650274|NCT02059135|Other Pre-specified|Number of Participants Experiencing Individual Maternal, Perinatal and Neonatal Outcomes and Number of Participants Who Avoided All Neonatal Morbidity and Mortality|Maternal and fetal/neonatal outcomes of specific interest were defined in the protocol. Maternal subjects were assessed through 4-6 weeks post delivery to determine if outcomes had occurred. Neonatal outcomes were assessed from birth until 36 weeks post menstrual age, or through the 4-6 week post delivery visit (if 36 weeks PMA occurs <28 days following delivery). A second fetal/neonatal composite outcome was the avoidance of fetal/neonatal mortality and neonatal morbidity [BPD, IVH grade ≥ 3, cystic PVL, ROP stage ≥ 3, late sepsis, and NEC (Bell’s stage ≥ 2)].|Maternal-till 4-6 weeks post delivery.Neonatal -birth until the later of 36 weeks PMA and the 36 weeks PMA visit, or through the 4-6 weeks post-delivery visit (if both 36 weeks PMA and the 36 weeks PMA visit occurred less than 28 days following delivery).|ITT||participants|||Number
650275|NCT02059135|Secondary|Composite Measure of Specific Fetal and Neonatal Outcomes Based on Protocol Defined 5-point Scale (Scores of 0 to 4)|"Composite score was calculated based on the following fetal and neonatal events: bronchopulmonary dysplasia (BPD), intraventricular hemorrhage (IVH), cystic periventricular leucomalacia (PVL), retinopathy of prematurity (ROP), late Sepsis, necrotizing enterocolitis (NEC) and mortality (fetal and neonatal). The endpoint is measured on a 5 point scale where 0 represents no outcomes experienced and no mortality, and 4 represents death, as shown below. Should the same outcome occur more than once, it will only be counted once.
Score Outcome 0 No events, no mortality
One event, no mortality
Two events, no mortality
Three or more events, no mortality
Death"|Neonatal outcomes were assessed from birth until the later of 36 weeks (wks) Post Menstrual Age (PMA) and the 36 wks PMA visit, or through the 4-6 weeks post-delivery visit (if both 36 wks PMA and the 36 wks PMA visit occurred < 28 days post delivery)|ITT||scores on a scale of 0 to 4||Standard Deviation|Mean
650276|NCT02059135|Primary|Increase in Gestational Age in Days|Increase in gestational age is defined as the gestational age at delivery minus the gestational age at randomization.|Subjects will continue on study drug until maternal and/or fetal indications for delivery necessitate cessation of expectant management or until 34 0/7 weeks of gestation.|ITT||days||Full Range|Median
650277|NCT02059070|Secondary|Post-operative Oxycodone Use (mg)|The total amount of oxycodone medication (mg) that the patient consumed in the 24 hours post surgery.|The 24 hour period following surgery|||mg||Standard Deviation|Mean
650278|NCT02059070|Other Pre-specified|Highest Patient Pain Level|The Visual analog pain scale ranges from 0 to 10, with higher scores indicating higher pain|Within 36 hours of surgery|||VAS units on a scale||Standard Deviation|Mean
650279|NCT02059070|Secondary|Ultrasonographic Evaluation of Diaphragmatic Excursion- Operative Side Sigh Test|For ultrasonographic evaluation if caudad movement of the hemidiaphragm was observed, the distance was measured recorded and assigned a positive (+) value. If paradoxical cephalad movement of the diaphragm was observed, the distance was given a negative value (-). Each measurement was performed 3 times and the best value was recorded.|Within 36hrs following surgery|||percentage of baseline change||Standard Deviation|Mean
650280|NCT02059070|Primary|Forced Expiratory Volume at 1 Second (% Change From Baseline)||Within the first 4 days following surgery|||percentage of change from baseline||Standard Deviation|Mean
650281|NCT02058992|Secondary|Percentage of Participants Who Responded With Improvement on the Patient Global Impression (PGI) Scale at Week 4|"PGI is a participant rated instrument to measure participant's change in overall status on a 7-point scale. 7 items on scale include sleep onset, sleep time, sleep quality, morning awakening, morning tiredness, daytime somnolence, and daytime physical condition/function. Participants provide their response on a PGI questionnaire. The results of survey using the PGI questionnaire was scored, summarized and assessed. Total score range from 1 (very much improved) to 7 (very much worse). Percentage of participants with improvement rated as much better or a little better were reported for sleep onset,time, quality; morning awakening, tiredness and daytime sleepiness, physical condition."|Week 4|The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available.||percentage of participants|||Number
650282|NCT02058992|Secondary|Sleep Status: Number of Awakenings|Sleep status of participants was assessed and summarized by calculating the number of times participants had awaken from the time of start of the investigation.|Baseline and Week 4|The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available.||number of awakenings||Standard Deviation|Mean
650283|NCT02058992|Secondary|Sleep Status: Total Sleep Time|Sleep status was determined by measuring the total sleep time, defined as the amount of actual sleep time during a sleep episode.|Baseline and Week 4|The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available.||hours||Standard Deviation|Mean
650284|NCT02058992|Secondary|Sleep Status: Sleep Onset Latency|Sleep status was determined by measuring the sleep onset latency, defined as the length of time taken from lying down for the night until sleep onset.|Baseline and Week 4|The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available.||minutes||Standard Deviation|Mean
651414|NCT02029521|Primary|Height Percentile|Height Percentile adjusted for sex and age|3 months|All participants.||Percentile adjusted for age and sex||Standard Deviation|Mean
650285|NCT02058992|Primary|Number of Participants Reporting One or More Serious Adverse Drug Reactions|Serious adverse drug reactions are defined as serious adverse events (SAE) which are in the investigator’s opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to 6 weeks|SAS was defined as participants who were enrolled and completed the study.||participants|||Number
650286|NCT02058992|Primary|Number of Participants Reporting One or More Adverse Drug Reactions|Adverse drug reactions are defined as adverse events (AE) which are in the investigator’s opinion of causal relationship to the study treatment. AE are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.|Baseline up to 6 weeks|Safety analysis set was defined as participants who were enrolled and completed the study.||participants|||Number
650287|NCT02058628|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAEs) Related to Study Medication|Adverse events are defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Serious adverse events are defined as any untoward medical occurrence that results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect and medically significant. TEAEs and TESAEs were reported up to 12 weeks.|Up to Week 12|ITT population.||Participants|||Count of Participants
650288|NCT02058628|Secondary|Absolute Change From Baseline in Total Score as Per Children’s Dermatology Life Quality Index (CDLQI) at Week 2,4,8 and 12|This outcome measure was a measure of QOL. The CDLQI was used to assess the quality of life at each visit. Participants completed the questionnaire to evaluate how their acne has affected their life. The DLQI is a 10 item questionnaire, which addresses feelings, daily activities, leisure, work, school, personal relationships, and treatment. Each question was scored out of 0–3, as follows: 0- Not at all, 1- A little, 2- A lot, 3- very much, indicating 0 as the least and 3 as the best quality Index. The sub-scale scores of 10 questions were combined and a composite score was presented. The total score ranged from 0 to 30, 0 indicated the least and highest score indicated the best quality Index. The CDLQI was for participants with 12 to 16 years of age. Baseline was defined at Visit 1 (Day 1). Change from Baseline is the value at indicated time point minus the Baseline value.|Baseline (Day 1) up to Weeks 2, 4, 8, 12|MITT population. Only those participants available at the indicated time points were analyzed.||Scores on a scale||Standard Deviation|Mean
650289|NCT02058628|Secondary|Absolute Change From Baseline in Total Score as Per Dermatology Life Quality Index (DLQI) at Week 2,4,8 and 12|This outcome measure was a measure of quality of life (QOL). The DLQI was used to assess the quality of life at each visit. Participants completed the questionnaire to evaluate how their acne has affected their life. The DLQI is a 10 item questionnaire, which addresses feelings, daily activities, leisure, work, school, personal relationships, and treatment. Each question was scored out of 0–3, as follows: 0- Not at all, 1- A little, 2- A lot, 3- very much, indicating 0 as the least and 3 as the best quality Index. The sub-scale scores of 10 questions were combined and a composite score was presented. The total score ranged from 0 to 30, 0 indicated the least and highest score indicated the best quality Index. The DLQI was for participants with 17 to 45 years of age. Baseline was defined at Visit 1 (Day 1). Change from Baseline is the value at indicated time point minus the Baseline value.|Baseline (Day 1) up to Weeks 2, 4, 8, 12|MITT population. Only those participants available at the indicated time points were analyzed.||Scores on a scale||Standard Deviation|Mean
650290|NCT02058628|Secondary|Number of Treatment Adherent Participants at Week 12|The general assessment of ‘overall satisfaction’ with study therapy was assessed at week 12 on a 0-4 point rating scale (0-Very satisfied, 1- Satisfied, 2- Neutral, 3- Unsatisfied and 4- Very unsatisfied).|Week 12|MITT population.||Participants|||Count of Participants
650291|NCT02058628|Secondary|Number of Participants With Participant Satisfaction Score at Week 12 (Simple Grading)|The product acceptability and preference questionnaire (PAP-Q ) served as a patient satisfaction score and was performed only once at the final study visit (ie, after 12 weeks (V5) or earlier in case of premature termination). Severity of each facial acne sign and symptom (scaling, redness, dryness, burning, itching) was based on a 0-5 point rating scale (0- None, 1- Very minimal, 2- Mild, 3- Moderate, 4- Severe, 5- Very severe).|Week 12|MITT population.||Participants|||Count of Participants
650292|NCT02058628|Secondary|Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12|Tolerability was assessed by the participants based on a 0–3 point rating scale for stinging/burning (S/B) and pruritus of the face (0- None, 1- Slight, 2- Moderate and 3- Strong). A shift table was provided to deduce how the results are varying from the Baseline visit to post-baseline visits.|Baseline (Day 1), Weeks 2, 4, 8 and 12|MITT population.||Participants|||Count of Participants
650293|NCT02058628|Secondary|Number of Participants With Participant Global Change Assessment Score 12 Weeks|An SGCA was conducted by the participant to assess the efficacy of treatment on Week 2, 4, 8 and 12 as Very Much Improved, Much Improved, Minimally Improved, No Change, Minimally Worse, Much Worse, Very Much Worse and missing.|Weeks 2, 4, 8 and 12|MITT population.||Participants|||Count of Participants
650294|NCT02058628|Secondary|Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12|Tolerability was assessed by investigator on a 0-3 point rating scale for erythema (0- None, 1- Slight, 2- Some and 3- Very red), dryness (0- None, 1- Slight, 2- Some and 3- Very dry) and peeling (0- None, 1- Slight, 2- Moderate and 3- Strong). A shift table was provided to deduce how the results are varying from the baseline visit to post-baseline visits. Change from Baseline is the value at indicated time point minus the Baseline value.|Baseline (Day 1) and Weeks 2, 4, 8, 12|MITT population.||Participants|||Count of Participants
650307|NCT02058563|Secondary|Number of Subjects Reporting Fever|Fever was assessed:Any fever (≥38°C) = occurrence of any fever regardless of its intensity grade or relationship to vaccination. Grade3 fever = fever >39.5°C. . Related = symptom assessed by the investigator as causally related to study vaccination.The preferred route for recording temperature in this study was oral.|During the 43 days (Days 0-42) post-vaccination period.|Total Vaccinated cohort included all vaccinated subjects with a documented vaccine administration.||Subjects|||Number
650295|NCT02058628|Secondary|Number of Participants With Change From Baseline in Investigator’s Static Global Assessment (ISGA) to Weeks 2,4,8 and 12|ISGA was conducted at all study visits. The area considered for the ISGA was confined to the face. A 0–5 point rating scale was used: 0 means Clear- Clear skin with no IL or NIL, 1 means Almost Clear- Rare NIL with no more than one small IL, 2 means Mild- Some NIL with no more than a few IL (papules/pustules only, no nodular lesions), 3 means Moderate- Up to many NIL and may have some IL, but no more than one small nodular lesion, 4 means Severe- Up to many NIL and IL, but no more than a few nodular lesions and 5 means Very Severe- Many NIL and IL and more than a few nodular lesions, may have cystic lesions.|Baseline (Day 1) up to Weeks 2, 4, 8, 12|MITT population.||Participants|||Count of Participants
650296|NCT02058628|Secondary|Speed of Onset : Time to 50 Percent Reduction in Total Lesion Count|The average time to 50 percent reduction of the calculated total lesion count was analyzed by determination of the number of days between Baseline and the first visit with a 50 percent reduction of the count.|Week 12|MITT population. Only those participants available at the indicated time points were analyzed.||Days||Full Range|Median
650297|NCT02058628|Secondary|Percentage Change From Baseline in IL, NIL and Calculated Total Lesions at Weeks 2, 4, 8 and 12|A count of IL (papules and pustules, including nasal lesions),NIL (open and closed comedones) and total lesions was performed at baseline and up to Week 12. Lesion counts were confined to the face. Baseline was defined at Visit 1 (Day 1). Change from Baseline in the number of IL was defined as week 12 values minus the Baseline values.|Baseline (Day 1) up to Week 2, 4, 8, 12|MITT population. Only those participants available at the indicated time points were analyzed.||Percent change||Standard Deviation|Mean
650298|NCT02058628|Secondary|Absolute Change From Baseline in IL, Non-inflammatory Lesions (NIL) and Calculated Total Lesions to Weeks 2, 4, 8 and 12|A count of IL (papules and pustules, including nasal lesions), NIL (open and closed comedones) and total lesions was performed at baseline and up to Week 12. Lesion counts were confined to the face. Baseline was defined at Visit 1 (Day 1). Change from Baseline in the number of IL was defined as week 12 values minus the Baseline values.|Baseline (Day 1) up to Week 2, 4, 8, 12|MITT population. Only those participants available at the indicated time points were analyzed.||Lesions||Standard Deviation|Mean
650299|NCT02058628|Primary|Percentage Change From Baseline (Day 1) of Inflammatory Lesion (IL) Count at Week 4 – Superiority Analysis|A count of IL (papules and pustules, including nasal lesions) was performed at baseline and up to Week 12. Lesion counts were confined to the face. Baseline was defined at Visit 1 (Day 1). Change from Baseline in the number of IL was defined as Week 4 values minus the Baseline values. Raw data has been presented for outcome measure results; however, p value is derived from the Wilcoxon test mean scores.|Baseline (Day 1) and Week 4|Modified intent-to-treat (MITT) population consisted of all participants in the ITT analysis set who had a baseline measurement of the number of IL and who had at least one post-baseline measurement of the number of IL.||Percent change||Standard Deviation|Mean
650300|NCT02058563|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|A serious adverse event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity.|Day 0 through the end of the study (Day 180)|Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
650301|NCT02058563|Secondary|Number of Subjects Reporting Adverse Events Prompting ER Visits|Occurrence of AEs prompting emergency room (ER) visits.|Day 0 through the end of the study (Day 180)|Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
650302|NCT02058563|Secondary|Number of Subjects Reporting NOCDs|Occurrence of new onset chronic diseases (NOCDs)|Day 0 through the end of the study (Day 180)|Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
650303|NCT02058563|Secondary|Number of Subjects Reporting Solicited Joint Pain (Arthralgia/Arthritis)|Assessed any, Grade-3, Related. Any= occurrence of any general symptom regardless of its intensity grade or relationship to vaccination; Grade3 joint pain (arthralgia/arthritis)= Pain which prevented normal, everyday activities (In adults/adolescents, such an AE could, for example, prevented attendance at work/school and could necessitated the administration of corrective therapy). Related = symptom assessed by the investigator as causally related to study vaccination.|During the 43 days (Days 0-42) post-vaccination period.|Total Vaccinated cohort included all vaccinated subjects with a documented vaccine administration.||subjects|||Number
650304|NCT02058563|Secondary|Number of Subjects Reporting Solicited Rash Symptom|Assessed any rash, Grade 3, Related, Localized rash, Generalized rash,measles/rubella-rash. Any= occurrence of any general symptom regardless of its intensity grade or relationship to vaccination. Grade3 rash/exanthema= Rash which prevented normal, everyday activities (In adults/adolescents, such an AE could, for example, prevented attendance at work/school and could necessitated the administration of corrective therapy). Grade 3 measles/rubella/varicella-like rash = Rash with more than150 lesions. Related = symptom assessed by the investigator as causally related to study vaccination.|During the 43 days (Days 0-42) post-vaccination period.|Total Vaccinated cohort included all vaccinated subjects with a documented vaccine administration.||Subjects|||Number
650305|NCT02058563|Secondary|Number of Subjects Reporting Unsolicited AEs|Any untoward medical occurrence in a patient or clinical investigation child, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product|During the 43 days (Days 0-42) post-vaccination period.|Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
650306|NCT02058563|Secondary|Number of Subjects Reporting Solicited General Symptoms as Parotid/Salivary Gland Swelling and Any Sign of Meningism/Seizure.|Assessed MMR specific symptoms were parotid/salivary gland swelling and any sign of meningism/seizure. Parotid/salivary gland swelling: Any = occurrence of any general symptoms regardless of their intensity grade or relationship to vaccination; Grade 3 Parotid/salivary gland swelling = Swelling accompanied with general symptoms. Meningism/seizure: Any= occurrence of any general symptoms regardless of their intensity grade or relationship to vaccination; Grade-3 meningism/seizure= Prevented normal, everyday activities (In adults/adolescents, such an AE could, for example, prevented attendance at work/school and could necessitated the administration of corrective therapy). Related symptom = symptom assessed by the investigator as causally related to study vaccination.|During the 43 days (Days 0-42) post-vaccination period.|Total Vaccinated cohort included all vaccinated subjects with a documented vaccine administration.||Subjects|||Number
651415|NCT02029521|Primary|Weight Percentile at 3 Months|Weight Percentile at 3 months adjusted for sex and age|3 months|All participants.||Weight Percentile, sex and age adjusted||Standard Deviation|Mean
650308|NCT02058563|Secondary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = Occurrence of any local symptom regardless of their intensity grade. Grade 3 Pain = Significant pain at rest. Prevented normal every day activities. Grade 3 redness = redness with surface diameter >50mm. Grade 3 swelling = swelling with surface diameter >50mm.|During the 4-day (Days 0-3) post-vaccination period|Total Vaccinated cohort included all vaccinated subjects with a documented vaccine administration.||Subjects|||Number
650309|NCT02058563|Secondary|Number of Subjects Who Achieved a 4-fold or Greater Rise in Anti-measles, Anti-mumps and Anti-rubella Virus Antibody Concentrations.|For subjects with seronegative status at pre-vaccination, a 4-fold rise in antibody concentration is defined as 4 times the cut-off level of the assay. Cut-off levels for anti-measles, anti-mumps and anti-rubella virus antibody concentrations are 150 mIU/mL, 5 EU/mL and 4 IU/mL.|At Day 42|ATP cohort for immunogenicity: included all eligible subjects with post-dose serology results available for at least one antigen of measles, mumps, or rubella, who complied with the protocol, who did not meet any elimination criteria and had no intercurrent medical conditions leading to elimination up to the Visit 2 (Day 42) blood sample.||Subjects|||Number
650310|NCT02058563|Secondary|Number of Subjects With Anti-rubella Virus Antibody Concentration Equal or Above the Threshold of 10 IU/mL (Seroresponse Rate).|"Seroresponse was defined as:
Anti-rubella virus antibody concentration equal to or above the threshold of 10 IU/mL after administration of INV_MMR vaccine vs. COM_MMR at Day 42."|At Day 42|ATP cohort for immunogenicity: included all eligible subjects with post-dose serology results available for at least one antigen of measles, mumps, or rubella, who complied with the protocol, who did not meet any elimination criteria and had no intercurrent medical conditions leading to elimination up to the Visit 2 (Day 42) blood sample.||Subjects|||Number
650311|NCT02058563|Secondary|Number of Subjects With Anti-mumps Virus Antibody Concentration Equal or Above the Threshold of 10 EU/mL (Seroresponse Rate).|"Seroresponse was defined as:
Anti-mumps virus antibody concentration equal to or above the threshold of 10 EU/mL after administration of INV_MMR vaccine vs. COM_MMR at Day 42."|At Day 42|ATP cohort for immunogenicity: included all eligible subjects with post-dose serology results available for at least one antigen of measles, mumps, or rubella, who complied with the protocol, who did not meet any elimination criteria and had no intercurrent medical conditions leading to elimination up to the Visit 2 (Day 42) blood sample.||Subjects|||Number
650312|NCT02058563|Secondary|Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Threshold of 200 mIU/mL (Seroresponse Rate)|"Seroresponse was defined as:
Anti-measles virus antibody concentration equal to or above the threshold of 200 mIU/mL after administration of INV_MMR vaccine vs. COM_MMR at Day 42."|At Day 42|ATP cohort for immunogenicity: included all eligible subjects with post-dose serology results available for at least one antigen of measles, mumps, or rubella, who complied with the protocol, who did not meet any elimination criteria and had no intercurrent medical conditions leading to elimination up to the Visit 2 (Day 42) blood sample.||Subjects|||Number
650313|NCT02058563|Primary|Anti-rubella Virus Antibody Concentrations.|Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in IU/mL. Seropositivity was defined as subjects with anti-rubella virus antibody concentration equal or greater than 4 IU/mL|At Day 42|ATP cohort for immunogenicity: included all eligible subjects with post-dose serology results available for at least one antigen of measles, mumps, or rubella, who complied with the protocol, who did not meet any elimination criteria and had no intercurrent medical conditions leading to elimination up to the Visit 2 (Day 42) blood sample.||IU/mL||95% Confidence Interval|Geometric Mean
650314|NCT02058563|Primary|Anti-mumps Virus Antibody Concentrations|Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in EU/mL. Seropositivity was defined as subjects with anti-mumps virus antibody concentration equal or greater than 5 EU/mL|At Day 42|ATP cohort for immunogenicity: included all eligible subjects with post-dose serology results available for at least one antigen of measles, mumps, or rubella, who complied with the protocol, who did not meet any elimination criteria and had no intercurrent medical conditions leading to elimination up to the Visit 2 (Day 42) blood sample.||EU/mL||95% Confidence Interval|Geometric Mean
650315|NCT02058563|Primary|Anti-measles Virus Antibody Concentrations.|Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in milli International Units per milliliter (mIU/mL). Seropositivity was defined as subjects with anti-measles virus antibody concentration equal or greater than 150 mIU/mL.|At Day 42|ATP cohort for immunogenicity: included all eligible subjects with post-dose serology results available for at least one antigen of measles, mumps, or rubella, who complied with the protocol, who did not meet any elimination criteria and had no intercurrent medical conditions leading to elimination up to the Visit 2 (Day 42) blood sample.||mIU/mL||95% Confidence Interval|Geometric Mean
650316|NCT02058537|Other Pre-specified|Change From Baseline Composite Vital Signs to Day 7|Vital signs include temperature, heart rate, breathing rate, and blood pressure. This variables will be measured during the study in order to assess any negative systemic effects of the study drug. These measurements are assessed as a composite and not individually therefore are grouped together as one outcome measure.|Day 1 and Day 7|We did not do the data analysis since the originating PI left the institution and the study was terminated.|||||
650317|NCT02058537|Secondary|Change From Baseline Evaluation of Esophageal Function Questionnaire to Day 7|This questionnaire allows the patient to assess their own symptoms and report their opinions about drug effectiveness.|Day 1 and Day 7|We did not do the data analysis since the originating PI left the institution and the study was terminated.|||||
650318|NCT02058537|Primary|Change From Baseline High Resolution Esophageal Manometry With Impedance to Day 7|The high resolution esophageal manometry with impedance involves a thin, pressure-sensitive tube that is passed through the nose and into the stomach. Once in place, the tube is pulled slowly back into the esophagus (food pipe). When the tube is in the esophagus, the patient is asked to swallow several times while swallowing water, applesauce, crackers, and marshmallows. These swallows will be completed while laying down, sitting upright, and standing. The pressure of the muscle contractions will be measured along several sections of the tube. The tube is removed after the tests are completed. This test allows for a quantitative measure of the pressure in the esophagus that can be correlated to difficulty or ease of bolus swallowing.|Day 1 and Day 7|We did not do the data analysis since the originating PI left the institution and the study was terminated.|||||
650319|NCT02058498|Secondary|Number of Patients Who Document Their Physical Activity|8 participants documented their physical activity at 6 weeks. 6 participants documented their physical activity at 4 months.|Baseline to 6 weeks, repeated measure at 4 months|||participants|||Number
650321|NCT02058498|Primary|Physical Activity Measured by the International Physical Activity Questionnaire (IPAQ)|The IPAQ calculates the metabolic equivalent (MET) score by asking participants the days and minutes exercised in three categories of intensity (vigorous, moderate, and walking) during the previous one week. The following formula is used to calculate the MET: MET=8(vigorous activity) (minutes) + 4 (moderate activity)(minutes) +3.3 (walking activity) (minutes).|Baseline, 6 weeks|||MET||Full Range|Median
650322|NCT02058290|Secondary|Patient Satisfaction With Pain Treatment After Surgery|Responses to question pertaining to patient satisfaction with pain treatment|Wound closure at time hospital discharge order is written or Day 30, whichever is sooner.|Of the 77 subjects who were enrolled in Group 1, 56 were included in the efficacy analysis set. Of the 45 subjects who were enrolled in Group 2, 26 were included in the efficacy analysis set.||participants|||Number
650323|NCT02058290|Secondary|Incidence of Opioid-related Adverse Events|Incidence of opioid-related adverse events defined as somnolence, respiratory depression, hypoventilation, hypoxia, dry mouth, nausea, vomiting, constipation, sedation, confusion, pruritus, urinary retention, and postoperative ileus.|Wound closure at time hospital discharge order is written or Day 30, whichever is sooner.|Of the 77 subjects who were enrolled in Group 1, 56 were included in the efficacy analysis set. Of the 45 subjects who were enrolled in Group 2, 26 were included in the efficacy analysis set.||participants|||Number
650324|NCT02058290|Primary|Health Economic Benefits - Length of Stay (LOS)|Length of stay, recorded in days, defined as the time of completion of the wound closure until the hospital discharge order is written or through Day 30, whichever is sooner.|Wound closure at time hospital discharge order is written or Day 30, whichever is sooner|Of the 77 subjects who were enrolled in Group 1, 56 were included in the efficacy analysis set. Of the 45 subjects who were enrolled in Group 2, 26 were included in the efficacy analysis set.||days||Full Range|Median
650325|NCT02058290|Primary|Health Economic Benefits - Total Cost of Hospitalization|Total cost of hospitalization until the time hospital discharge order is written or through Day 30, whichever was sooner.|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|Of the 77 subjects who were enrolled in Group 1, 56 were included in the efficacy analysis set. Of the 45 subjects who were enrolled in Group 2, 26 were included in the efficacy analysis set.||dollars||Standard Deviation|Mean
650326|NCT02058290|Primary|Total Opioid Burden|Total opioid consumed (IV and PO) postsurgically until hospital discharge order is written or through Day 30, whichever is sooner.|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|Of the 77 subjects who were enrolled in Group 1, 56 were included in the efficacy analysis set. Of the 45 subjects who were enrolled in Group 2, 26 were included in the efficacy analysis set.||mg||Standard Deviation|Mean
650327|NCT02058160|Secondary|Percentage of Participants With Severe Symptomatic Hypoglycemia|Severe symptomatic hypoglycemia was an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Plasma glucose measurements might not had been available during such an event, but neurological recovery attributable to the restoration of plasma glucose to normal was considered sufficient evidence that the event had been induced by a low plasma glucose concentration. Severe symptomatic hypoglycemia included all episodes in which neurological impairment was severe enough to prevent self-treatment, and which were thus thought to place participants at risk for injury to themselves or others.|First dose of study drug up to 1 day after the last dose administration (median treatment exposure 211 days [FRC], 210 days [Insulin glargine])|Analysis was performed on safety population.||percentage of participants|||Number
650328|NCT02058160|Secondary|Percentage of Participants With Documented Symptomatic Hypoglycemia|Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L).|First dose of study drug up to 1 day after the last dose administration (median treatment exposure 211 days [FRC], 210 days [Insulin glargine])|Analysis was performed on safety population.||percentage of participants|||Number
650329|NCT02058160|Secondary|Number of Documented Symptomatic Hypoglycemia Events Per Subject-Year|Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L).|First dose of study drug up to 1 day after the last dose administration (median treatment exposure 211 days [FRC], 210 days [Insulin glargine])|Analysis was performed on safety population defined as all randomized participants who received at least one dose of IMP regardless of the amount of treatment administered.||events per subject-year|||Number
650330|NCT02058160|Secondary|Percentage of Participants Requiring Rescue Therapy During 30-Week Treatment Period|Routine fasting SMPG and central laboratory FPG (and HbA1c after Week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after Week 12) were performed. Threshold values - from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 30: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >8%.|Baseline up to Week 30|mITT population.||percentage of participants|||Number
650331|NCT02058160|Secondary|Percentage of Participants Reaching HbA1c <7.0% With No Documented Symptomatic Hypoglycemia (PG ≤ 70 mg/dL [3.9 mmol/L]) During 30-Week Treatment Period|Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L).|Baseline up to Week 30|mITT population. Participants with no value for HbA1c at Week 30 were counted as non-responders.||percentage of participants|||Number
650332|NCT02058160|Secondary|Change in 2-hour PPG From Baseline to Week 30|Change in PPG was calculated by subtracting baseline value from Week 30 value.|Baseline, Week 30|mITT population. Here, number of participants analyzed= participants with baseline and at least one post-baseline PPG assessment during study period.||mmol/L||Standard Error|Least Squares Mean
650333|NCT02058160|Secondary|Change in FPG From Baseline to Week 30|Change in FPG was calculated by subtracting baseline value from Week 30 value.|Baseline, Week 30|mITT population. Here, number of participants analyzed= participants with baseline and at least one post-baseline FPG assessment during study period.||mmol/L||Standard Error|Least Squares Mean
650408|NCT02056392|Primary|Change From Baseline in QTcF|Change from baseline in QTcF at 24 hours (msec)|24 hours|All patients who had evaluable pharmacodynamic data available for at least one treatment group were included in the PD analysis set||msec|Participants|95% Confidence Interval|Least Squares Mean
650334|NCT02058160|Secondary|Percentage of Participants Reaching HbA1c <7.0% With No Body Weight Gain at Week 30 and No Documented Symptomatic Hypoglycemia (Plasma Glucose [PG] ≤ 70 mg/dL [3.9 mmol/L]) During 30-Week Treatment Period|Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L).|Baseline up to Week 30|mITT population. Participants without HbA1c and/or body weight value at Week 30 were counted as non-responders.||percentage of participants|||Number
650335|NCT02058160|Secondary|Change in Daily Insulin Glargine Dose From Baseline to Week 30||Baseline, Week 30|mITT population. The analysis included scheduled measurements obtained up to the date of last injection of IMP. Here, number of participants analyzed= participants with insulin glargine dose assessment during study period.||Units (U)||Standard Error|Least Squares Mean
650336|NCT02058160|Secondary|Percentage of Participants Reaching HbA1c <7.0% With No Body Weight Gain at Week 30||Week 30|mITT population. Participants without HbA1c and/or body weight value at Week 30 were counted as non-responders.||percentage of participants|||Number
650337|NCT02058160|Secondary|Mean Change in 7-point Self-monitored Plasma Glucose (SMPG) Profile From Baseline to Week 30|Participants recorded a 7-point plasma glucose profile measured before and 2-hours after each meal and at bedtime, two times in a week before baseline, before visit Week 12 and before visit Week 30 and the average value across the profiles performed in the week before a visit for the 7 time points was calculated. Change in average 7 point SMPG was calculated by subtracting baseline value from Week 30 value. The analysis included all scheduled measurements obtained during the study. The missing data was handled by mixed effect model with repeated measures (MMRM) approach.|Baseline, Week 30|mITT population. Here, number of participants analyzed= participants with baseline and at least one post-baseline 7-point SMPG assessment during study period.||mmol/L||Standard Error|Least Squares Mean
650338|NCT02058160|Secondary|Change in Body Weight From Baseline to Week 30|Change in body weight was calculated by subtracting baseline value from Week 30 value.|Baseline, Week 30|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline body weight assessment during study period.||kg||Standard Error|Least Squares Mean
650339|NCT02058160|Secondary|Change in 2-hour Plasma Blood Glucose Excursion From Baseline to Week 30|Plasma glucose excursion = 2-hour postprandial glucose (PPG) minus plasma glucose value obtained 30 minutes prior to the start of the meal and before investigational medicinal product (IMP) administration, if IMP was injected before breakfast. Change in plasma glucose excursions was calculated by subtracting baseline value from Week 30 value.|Baseline, Week 30|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline plasma glucose excursion assessment during study period. Missing data was imputed using last observation carried forward (LOCF).||mmol/L||Standard Error|Least Squares Mean
650340|NCT02058160|Secondary|Percentage of Participants With HbA1c <7.0% or ≤6.5% at Week 30||Week 30|mITT population. Participants with no value for HbA1c at Week 30 were counted as non-responders.||percentage of participants|||Number
650341|NCT02058160|Primary|Change in Glycated Hemoglobin (HbA1c) From Baseline to Week 30|Change in HbA1c was calculated by subtracting baseline value from Week 30 value.|Baseline, Week 30|Modified intent-to-treat (mITT) population: all randomized participants who had both baseline and at least one post-baseline efficacy assessment. Here, number of participants analyzed = participants with baseline and at least one post-baseline HbA1c assessment during study period.||percentage of HbA1c||Standard Error|Least Squares Mean
650342|NCT02058147|Secondary|Percentage of Participants With Severe Symptomatic Hypoglycemia|Severe symptomatic hypoglycemia was an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Plasma glucose measurements might not have been available during such an event, but neurological recovery attributable to the restoration of plasma glucose to normal was considered sufficient evidence that the event had been induced by a low plasma glucose concentration. Severe symptomatic hypoglycemia included all episodes in which neurological impairment was severe enough to prevent self-treatment, and which were thus thought to place participants at risk of injury to themselves or others.|First dose of study drug up to 1 day after the last dose administration (median treatment exposure: 211 days)|Safety population.||percentage of participants|||Number
650343|NCT02058147|Secondary|Percentage of Participants With Documented Symptomatic Hypoglycemia|Documented symptomatic hypoglycemia was an event during which symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤ 70 mg/dL (3.9 mmol/L).|First dose of study drug up to 1 day after the last dose administration (median treatment exposure: 211 days)|Safety population.||percentage of participants|||Number
650344|NCT02058147|Secondary|Number of Documented Symptomatic Hypoglycemia Events Per Subject-Year|Documented symptomatic hypoglycemia was an event during which symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤ 70 mg/dL (3.9 mmol/L).|First dose of study drug up to 1 day after the last dose administration (median treatment exposure: 211 days)|Analysis was performed on safety population defined as all randomized participants who received at least one dose of IMP regardless of the amount of treatment administered.||Events per subject-year|||Number
650345|NCT02058147|Secondary|Percentage of Participants Requiring Rescue Therapy During 30-Week Treatment Period|Routine fasting SMPG and central laboratory FPG (and HbA1c after Week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after Week 12) was performed. Threshold values - from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 30: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >8%.|Baseline up to Week 30|mITT population.||percentage of participants|||Number
650346|NCT02058147|Secondary|Percentage of Participants Reaching HbA1c <7.0% at Week 30 With No Documented Symptomatic Hypoglycemia (PG ≤ 70 mg/dL [3.9 mmol/L]) During 30-Week Treatment Period|Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L). The analysis included all HbA1c measurements at Week 30, including those obtained after the IMP discontinuation or the introduction of rescue medication.|Baseline up to Week 30|mITT population. Participants without Week 30 value for HbA1c were counted as non-responders.||percentage of participants|||Number
650409|NCT02056392|Primary|Change From Baseline in QTcF|Change from baseline in QTcF at 12 hours (msec)|12 hours|All patients who had evaluable pharmacodynamic data available for at least one treatment group were included in the PD analysis set||msec|Participants|95% Confidence Interval|Least Squares Mean
650347|NCT02058147|Secondary|Change in 2-Hour Postprandial Plasma Glucose (PPG) From Baseline to Week 30|The 2-hour PPG test measured blood glucose 2 hours after eating a liquid standardized breakfast meal. Change in PPG was calculated by subtracting baseline value from Week 30 value. Missing data was imputed using LOCF.|Baseline, Week 30|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline 2-hour PPG assessment during study period.||mmol/L||Standard Error|Least Squares Mean
650348|NCT02058147|Secondary|Average Daily Insulin Glargine Dose at Week 30|The analysis included scheduled measurements obtained up to the date of last injection of the IMP, including those obtained after introduction of rescue therapy.|Week 30|mITT population. Here, number of participants analyzed = participants with insulin glargine dose assessment during study period. Data of this endpoint was planned to be analyzed for Insulin Glargine/Lixisenatide FRC and Insulin glargine arms only, not for lixisenatide arm.||Units (U)||Standard Error|Least Squares Mean
650349|NCT02058147|Secondary|Percentage of Participants Reaching HbA1c <7.0% With No Body Weight Gain at Week 30 and No Documented Symptomatic Hypoglycemia (Plasma Glucose [PG] ≤ 70 mg/dL [3.9 mmol/L]) During 30-Week Treatment Period|Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L).|Baseline up to Week 30|mITT population. Participants without any HbA1c and/or body weight value at Week 30 were counted as non-responders.||percentage of participants|||Number
650350|NCT02058147|Secondary|Percentage of Participants Reaching HbA1c <7.0% With No Body Weight Gain at Week 30||Week 30|mITT population. Participants without any HbA1c and/or body weight value at Week 30 were counted as non-responders.||percentage of participants|||Number
650351|NCT02058147|Secondary|Mean Change in 7-point Self-monitored Plasma Glucose (SMPG) Profile From Baseline to Week 30|Participants recorded a 7-point plasma glucose profile measured before and 2 hours after each meal and at bedtime two times in a week before baseline, before visit Week 12 and before visit Week 30 and the average value across the profiles performed in the week before a visit for the 7-time points was calculated. Change in average 7-point SMPG was calculated by subtracting baseline value from Week 30 value. The analysis included all scheduled measurements obtained during the study. The missing data was handled by mixed effect model with repeated measures (MMRM) approach.|Baseline, Week 30|mITT population. Here,number of participants analyzed = participants with baseline and at least one post baseline 7-point SMPG assessment during study period.||mmol/L||Standard Deviation|Least Squares Mean
650352|NCT02058147|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 30|Change in FPG was calculated by subtracting baseline value from Week 30 value.|Baseline, Week 30|mITT population. Here, number of participants analysed = participants with baseline and at least one post-baseline FPG assessment during study period.||mmol/L||Standard Error|Least Squares Mean
650353|NCT02058147|Secondary|Change in Body Weight From Baseline to Week 30|Change in body weight was calculated by subtracting baseline value from Week 30 value.|Baseline, Week 30|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline body weight assessment during study period.||kg||Standard Error|Least Squares Mean
650354|NCT02058147|Secondary|Change in Plasma Glucose Excursion From Baseline to Week 30|Plasma glucose excursion = 2-hour postprandial plasma glucose (PPG) value minus plasma glucose value obtained 30 minutes prior to the start of meal and before investigational medicinal product (IMP) administration if IMP was injected before breakfast. Change in plasma glucose excursions were calculated by subtracting baseline value from Week 30 value. Missing data was imputed using last observation carried forward (LOCF).|Baseline, Week 30|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline plasma glucose excursion assessment during study period.||mmol/L||Standard Error|Least Squares Mean
650355|NCT02058147|Secondary|Percentage of Participants With HbA1c <7.0% or ≤6.5% at Week 30|Participants without Week 30 value for HbA1c were counted as non-responders.|Week 30|mITT population.||percentage of participants|||Number
650356|NCT02058147|Primary|Change in HbA1c From Baseline to Week 30|"Primary outcome was to test superiority of FRC versus Lixisenatide and non-inferiority versus Insulin glargine.
Change in HbA1c was calculated by subtracting baseline value from Week 30 value."|Baseline, Week 30|Modified intent-to-treat (mITT) population: all randomized participants who had both baseline and at least one post-baseline efficacy assessment. Here, number of participants analyzed = participants with baseline and at least one post-baseline HbA1c assessment during study period.||percentage of hemoglobin||Standard Error|Least Squares Mean
650357|NCT02058069|Other Pre-specified|Patient Satisfaction - Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC)|"The WOMAC collects information specific to osteoarthritis outcomes. The patient-response questionnaire uses a visual analog scale for pain, measuring factors of general pain, stiffness, and function. Each question is scored from 0 to 4 for each set of factors, with 0 indicating no pain, stiffness, or limit in function, and 4 indicating extreme pain, stiffness, or limit in function. Total WOMAC scores range from 0 to 96 with lower values representing better outcomes.
The posted mean, noted as a negative number, represents the mean DECREASE in total WOMAC score from pre-operative to 3 month post-operative patient assessment."|Pre-Op, 3 Month Post Op [change assessed between the two time periods]|participants = knees.||units on a scale||Standard Deviation|Mean
650358|NCT02058069|Secondary|Participants With Limb Alignment Difference <4.38 Degrees|The difference between the actual 3 month limb alignment was compared to the pre-op planned alignment. Any measurement difference <4.38 was considered a success; >4.38 degrees was considered a failure.|Pre-op Plan, 3 Month Post Op|Participants = knees||Participants|||Count of Participants
650359|NCT02058069|Secondary|Change in the Radiographic Assessment of Limb Alignment From Pre-Operative to 3 Months Post-Operative|Radiographic limb alignment of the operative knee according to the technique defined by Barrack et al. was assessed at the 3 month post-operative follow-up by two independent reviewers. The measured post-operative limb alignment was to be compared to the planned pre-operative limb alignment as extracted from the system log file.|pre-op plan, 3 Month Post Op|Of the 89 patients who received a robotic assisted total knee arthroplasty as part of the IDE, 2 patients were excluded from analysis for the Secondary Endpoint only due to issues related to the accurate measurement of limb alignment from the radiographs available (not for reasons involving the surgical procedure or clinical outcomes).||degrees||Standard Deviation|Mean
654458|NCT01965288|Primary|Overall Stability|Assessment of Lens Fit Performance for overall lens stability. Collected at 4 weeks for each lens. (Excellent or Good.|4 weeks|All 60 subjects randomized to both sets of lenses.||percentage of lenses|Participants||Number
650360|NCT02058069|Primary|Intra-Operative Complications|Surgeon assessment of standardized TKA complications (Healey et al. CORR 2012) both intra-operatively and at short term follow up. The nine complications relating to soft tissue damage for primary TKA that were assessed as part of this study were as follows: Blood loss, Vascular injury, MCL injury, Periprosthetic fracture, Extensor mechanism disruption, Patellofemoral dislocation, Tibiofemoral dislocation, Neurological impairment, Instability.|3 Month Post Op|participants = knees.||intra-operative complications|||Number
650361|NCT02058069|Primary|Intra-Operative Complications|Surgeon assessment of standardized TKA complications (Healey et al. CORR 2012) both intra-operatively and at short term follow up. The nine complications relating to soft tissue damage for primary TKA that were assessed as part of this study were as follows: Blood loss, Vascular injury, MCL injury, Periprosthetic fracture, Extensor mechanism disruption, Patellofemoral dislocation, Tibiofemoral dislocation, Neurological impairment, Instability.|Subjects will be assessed for incidence of intra-operative complications at the conclusion of their hospital stay, or an average of 3 days post-operatively.|participants = knees.||intra-operative complications|||Number
650362|NCT02058069|Primary|Intra-Operative Complications|Surgeon assessment of standardized TKA complications (Healey et al. CORR 2012) both intra-operatively and at short term follow up. The nine complications relating to soft tissue damage for primary TKA that were assessed as part of this study were as follows: Blood loss, Vascular injury, MCL injury, Periprosthetic fracture, Extensor mechanism disruption, Patellofemoral dislocation, Tibiofemoral dislocation, Neurological impairment, Instability.|Subject will be assessed for these complications intra-operatively. The assessment occurs after the surgeon has completed the surgical procedure, but while the subject is still in the operating room with the surgeon.|participants = knees.||intra-operative complications|||Number
650363|NCT02057835|Secondary|Terminal Half-life of the Analyte (T1/2) - Overall|Terminal half-life (T1/2) of the analyte in plasma/whole blood for all participants (Chinese and Japanese)|1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration|All subjects of the treated set with the pharmacokinetic (PK) parameter calculated.||hours||Geometric Coefficient of Variation|Geometric Mean
650364|NCT02057835|Secondary|Terminal Half-life of the Analyte (T1/2)|Terminal half-life (T1/2) of the analyte in plasma/whole blood|1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration|All subjects of the treated set with the pharmacokinetic (PK) parameter calculated.||hours||Geometric Coefficient of Variation|Geometric Mean
650365|NCT02057835|Secondary|Area Under the Concentration-time Curve of the Analyte Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point (AUC0-tz) - Overall|Area under the concentration-time curve of the analyte in plasma/whole blood over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz) for all participants (Chinese and Japanese)|1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration|All subjects of the treated set with the pharmacokinetic (PK) parameter calculated.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
650366|NCT02057835|Secondary|Area Under the Concentration-time Curve of the Analyte Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point (AUC0-tz)|Area under the concentration-time curve of the analyte in plasma/whole blood over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz)|1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration|All subjects of the treated set with the pharmacokinetic (PK) parameter calculated.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
650367|NCT02057835|Secondary|Area Under the Concentration-time Curve of the Analyte Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity) - Overall|Area under the concentration-time curve of the analyte in plasma/whole blood over the time interval from 0 extrapolated to infinity for all participants (Chinese and Japanese)|1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration|All subjects of the treated set with the pharmacokinetic (PK) parameter calculated.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
650368|NCT02057835|Secondary|Area Under the Concentration-time Curve of the Analyte Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity)|Area under the concentration-time curve of the analyte in plasma/whole blood over the time interval from 0 extrapolated to infinity (AUC0-infinity)|1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration|All subjects of the treated set with the pharmacokinetic (PK) parameter calculated.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
650369|NCT02057835|Secondary|Time From Dosing to the Maximum Measured Concentration of the Analyte (Tmax) - Overall|Time from (last) dosing to the maximum measured concentration of the analyte in plasma/whole blood for all participants (Chinese and Japanese)|1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration|All subjects of the treated set with the pharmacokinetic (PK) parameter calculated.||hours||Full Range|Median
650370|NCT02057835|Secondary|Time From Dosing to the Maximum Measured Concentration of the Analyte (Tmax)|Time from (last) dosing to the maximum measured concentration of the analyte in plasma/whole blood|1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration|All subjects of the treated set with the pharmacokinetic (PK) parameter calculated.||hours||Full Range|Median
650371|NCT02057835|Secondary|Maximum Measured Concentration of the Analyte (Cmax) - Overall|Maximum measured concentration of the analyte in plasma/whole blood for all participants (Chinese and Japanese)|1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration|All subjects of the treated set with the pharmacokinetic (PK) parameter calculated.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
650372|NCT02057835|Secondary|Maximum Measured Concentration of the Analyte (Cmax)|Maximum measured concentration of the analyte in plasma/whole blood|1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration|All subjects of the treated set with the pharmacokinetic (PK) parameter calculated.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
650373|NCT02057835|Primary|Percentage of Participants With Drug Related Adverse Events|Percentage of participants with drug related adverse events (AEs)|From drug administration until 31 days after drug administration, 31 days|Treated set||Percentage of participants|||Number
650374|NCT02057549|Secondary|Nausea Relief as Indicated by Number of Participants Not Requesting Additional Antiemetic Medication||1 hour after study medication given|||Participants|||Count of Participants
650375|NCT02057549|Secondary|Nausea Score as Measured by a Visual Analogue Scale (VAS)|The Visual Analogue Scale (VAS) ranges from 1-5, with 1 being minimal nausea and 5 being severe nausea.|1 hour after study medication given|||units on a scale||Standard Deviation|Mean
650376|NCT02057549|Secondary|Nausea Score as Measured by a Visual Analogue Scale (VAS)|The Visual Analogue Scale (VAS) ranges from 1-5, with 1 being minimal nausea and 5 being severe nausea.|before study medication given|||units on a scale||Standard Deviation|Mean
650377|NCT02057549|Secondary|Pain Score as Measured by a Visual Analogue Scale (VAS)|The Visual Analogue Scale (VAS) ranges from 0-10, with 0 being the absence of pain and 10 the worst imaginable pain.|1 hour after study medication given|||units on a scale||Standard Deviation|Mean
650378|NCT02057549|Secondary|Pain Score as Measured by a Visual Analogue Scale (VAS)|The Visual Analogue Scale (VAS) ranges from 0-10, with 0 being the absence of pain and 10 the worst imaginable pain.|before study medication given|||units on a scale||Standard Deviation|Mean
650379|NCT02057549|Secondary|Emergency Department Length of Stay (EDLOS)|"The time frame starts from the moment of receiving the study drug to the time when the decision for final disposition is made. Usually after symptoms are controlled, patients are given a PO challenge (food or drink) in order to establish if they are OK to go home. If symptoms return, additional medications are given, the treatment is consider failed and they are admitted to the Hospital.
Patients will not be followed up if admitted to any service. The study ends when final disposition is made.
Patients follow up after final disposition is not part of the study and will not be done."|at the time the decision for final disposition is made (about 8 hours)|||hours||Inter-Quartile Range|Median
650380|NCT02057549|Secondary|Number of Participants Admitted to the Hospital After Emergency Department Visit||2 hours after study medication given|||Participants|||Count of Participants
650381|NCT02057549|Primary|Pain Relief as Indicated by Number of Participants Not Requesting Additional Pain Medication||1 hour after study medication given|||Participants|||Count of Participants
650382|NCT02057406|Primary|Endpoint Red Blood Cell/Plasma EPA Values Adjusted for Age, Sex, Treatment Site, and Baseline Red Blood Cell/Plasma EPA Values.|Endpoint EPA values are mean values adjusted for age, race, sex, treatment site, and the baseline EPA value. Red blood cell/plasma EPA values are expressed as a percent of total identified fatty acids.|Week 12|"The numbers at baseline reflect the total number of patients who provided samples for the assay of omega 3 percentage of total fatty acids.
The numbers at endpoint reflect the total number of patients included in the intention to treat analysis."||percentage of total fatty acids||Standard Error|Mean
650383|NCT02057406|Primary|Endpoint Hamilton Depression Rating Scale (HAMD) Scores Adjusted for Age, Sex, Treatment Site, and Baseline HAMD Scores.|Endpoint HAMD scores are mean values adjusted for age, race, sex, treatment site, and the baseline HAMD value. The range for the HAMD scores is 0 to 52 with higher scores indicating a greater severity of depressive symptoms.|Week 12|||units on a scale||Standard Error|Mean
650384|NCT02057393|Primary|Equivalence of ICG and Real Time Lymphangiography to technetium99 and Blue Dye in Localizing Sentinel Nodes|The primary outcome measure is the accuracy of indocyanine green (ICG) and real time lymphangiography to identify sentinel nodes (SLN) in patients with melanoma, compared to tech99 and methylene blue. Tech99 is considered the standard, for comparison. Accuracy is being determined by the number of sentinel nodes that are identified with ICG, compared to tech99 or methylene blue.|2 weeks|||number of sentinel nodes per patient||Standard Deviation|Mean
650385|NCT02057276|Other Pre-specified|"Change in the Melbourne Assessment of Unilateral Upper Limb Function"||"Change in the Melbourne Assessment of Unilateral Upper Limb Function between baseline and 12 weeks after rTMS/OT"|After signing consent forms, two separate participants did not proceed with the study. The study was then terminated.|||||
650386|NCT02057276|Other Pre-specified|"Change in the Melbourne Assessment of Unilateral Upper Limb Function"||"Change in the Melbourne Assessment of Unilateral Upper Limb Function between baseline and 7 days after rTMS/OT"|After signing consent forms, two separate participants did not proceed with the study. The study was then terminated.|||||
650387|NCT02057276|Primary|"Change in the Melbourne Assessment of Unilateral Upper Limb Function"||"Change in the Melbourne Assessment of Unilateral Upper Limb Function between baseline and 3 days after rTMS/OT"|After signing consent forms, two separate participants did not proceed with the study. The study was then terminated.|||||
650388|NCT02057250|Secondary|Area Under the Serum Concentration Versus Time Curve Calculated Using the Trapezoidal Method During a Dose Interval (AUC[0-tau]) for Sarilumab|AUC(0-tau) is defined as area under the serum concentration versus time curve calculated using the trapezoidal method during a dose interval, where dose interval was 2 weeks. Serum concentrations of sarilumab were analyzed using validated enzyme linked immunosorbent assay (ELISA).|Week 0-2: pre-dose on Day 1, anytime post-dose on Day 3, Day 5, Day 8, Day 12, Day 15; Week 10-12: pre-dose on Day 71, anytime post-dose on Day 73, Day 75, Day 78, Day 82, Day 85|Pharmacokinetic(PK) population included all randomized participants who received at least 1 dose of IMP and have least 1 PK parameter calculated using non compartmental methods following the first (Day 1) or sixth administration (Day 71). Here, Number Analyzed = participants with available data for specified category for each arm, respectively.||mg*day/L||Standard Deviation|Mean
650410|NCT02056392|Primary|Change From Baseline in QTcF|Change from baseline in QTcF at 8 hours (msec)|8 hours|All patients who had evaluable pharmacodynamic data available for at least one treatment group were included in the PD analysis set||msec|Participants|95% Confidence Interval|Least Squares Mean
651495|NCT02028676|Primary|Induction ART: Change From Baseline in CD4% 72 Weeks After ART Initiation||Baseline, 72 weeks|All participants alive at 72 weeks with CD4 measured (completeness in those in follow-up was 96.6%).||percentage of total lymphocytes||Standard Error|Mean
650389|NCT02057250|Primary|Number of Validated AID Associated Product Technical Failures (PTFs)|A PTF was defined as any product technical complaint (PTC) related to the use of the AID that had a validated technical cause. Each participant was given a diary having questions related to participant's ability to remove the cap, to start the injection, to complete the injection and regarding confirmation of completing the injection. Participants were asked to answer the questions each time they self-inject the sarilumab. If the response was “no” to any of the first 3 questions, this was considered as a PTC. The used AID, for which PTC was reported, was sent to sponsor, examined and evaluated for the occurrence of a PTF.|Baseline up to Week 12|Modified intent-to-treat (mITT) population included all randomized participants who received at least 1 dose of investigational medicinal product (IMP) with AID and attended at least 1 post-baseline visit during AID assessment phase of the study.||PTFs|Injections||Number
650390|NCT02057237|Secondary|Prostate Specific Antigen (PSA) Response Rate|"Continue increase of serum PSA beyond 8 weeks indicate PSA progression. Response and progression will be primarily evaluated in this study using PSA response criteria from the Prostate Cancer Working Group 2. Criteria used to define response include: at least a 50% decline in PSA, confirmed by a second measurement ≥4 weeks later. PSA progression is defined by a >25% increase from baseline in patients whose PSA did not decrease, and of 50% from the nadir value in patients whose PSA decreased. This increase in PSA must be >5 ng/ml, and confirmed by a second measurement, at least 1 week later; PSA nadir is defined as the minimum PSA value that was confirmed by a second measurement.
PSA progression free survival is defined as the time between the randomization date and the date of PSA progression or the date of death due to prostate cancer, whichever occurs first."|PSA progression free survival and excessive toxicity. Plan to keep the patients on Mitotane for atleast 8 weeks, despite increasing level of PSA as other trials shown early increase in PSA followed by a subsequent decline.||||||
650391|NCT02057237|Primary|The Primary Endpoint is the Proportion of Patients Maintained on Mitotane After 12 Consecutive Weeks of Therapy. A Positive Outcome Would be Seeing 50% or More Patients Maintained on Therapy. Secondary Endpoint Include Proportion of Adverse Events||maintain 50% of the patients on Mitotane at the 12 week mark|As only 1 patient was accrued to this trial, no data analysis was performed.|||||
650392|NCT02056834|Primary|Mean Time to Union|Mean time to union was calculated based on the Kaplan-Meier estimator of the survivorship function|12 months|||months||Standard Deviation|Mean
650393|NCT02056834|Secondary|Lysholm Knee Scale|The Lysholm knee scale is a condition-specific outcome measure that was originally designed to assess ligament injuries of the knee. The survey was administered to subject at follow-up visits and comprises 8 subscales related to limp, support, stair climbing, squatting, walking, running and jumping as well as a question related to the atrophy of the thigh. The responses to these 8 questions are graded to provide a maximum result of 100 points.|12 months|||participants|||Number
650394|NCT02056834|Secondary|VAS Leg Pain Frequency|The subjects completed questionnaires assessing the intensity and frequency of pain experienced in the leg at the baseline visit and postoperatively. Pain frequency was rated on a 100-mm visual analog scale where zero indicated no pain at all and 100 represented pain always.|12 months|||units on a scale||Standard Deviation|Mean
650395|NCT02056834|Secondary|VAS Leg Pain Intensity|The subjects completed questionnaires assessing the intensity and frequency of pain experienced in the leg at the baseline visit and postoperatively. Pain intensity was rated on a 100-mm visual analog scale where zero indicated no pain at all, and 100 represented the worst possible pain.|12 months|||units on a scale||Standard Deviation|Mean
650396|NCT02056834|Secondary|SF-12 Short Form Health Survey Mental Composite Score (MCS)|The SF-12 short form health survey was self-administered to subjects preoperatively and at follow up visits. This health survey comprises 12 questions related to health and wellbeing over the prior four weeks. The responses to these 12 questions are entered into a standardized algorithm to provide summaries of physical and mental health (i.e., physical composite score [PCS] and mental composite score [MCS]). The summary scores are standardized and normalized such that a score of 50 for either the PCS or MCS corresponds to that of an average, healthy person. A score lower than 50 indicates poorer physical and mental health compared to an average, healthy person.|12 months|||units on a scale||Standard Deviation|Mean
650397|NCT02056834|Secondary|SF-12 Short Form Health Survey Physical Composite Score (PCS)|The SF-12 short form health survey was self-administered to subjects preoperatively and all follow up visits. This health survey comprises 12 questions related to health and wellbeing over the prior four weeks. The responses to these 12 questions are entered into a standardized algorithm to provide summaries of physical and mental health (i.e., physical composite score [PCS] and mental composite score [MCS]). The summary scores are standardized and normalized such that a score of 50 for either the PCS or MCS corresponds to that of an average, healthy person. A score lower than 50 indicates poorer physical and mental health compared to an average, healthy person.|12 months|||units on a scale||Standard Deviation|Mean
650398|NCT02056834|Secondary|Peri-operative Complications||12 months|||participants|||Number
650399|NCT02056834|Secondary|Extension Ability and Stability|"The following was assessed:
extension ability of the knee
stability of the knee in extension"|12 months|||participants|||Number
650400|NCT02056834|Secondary|Surgeon’s Satisfaction With the Product|Satisfaction with product was assessed by the surgeon post-operatively, where surgeons indicated their satisfaction with treatment on a 100-mm visual analog scale. A score of zero indicated absolutely unacceptable, while a score of 100 indicated very satisfying.|Post-surgery|||units on a scale||Standard Deviation|Mean
650401|NCT02056834|Secondary|Patient’s Satisfaction|Satisfaction with treatment was assessed by the subjects, where subjects indicated their satisfaction with treatment on a 100-mm visual analog scale. A score of zero indicated no satisfaction, while a score of 100 indicated completely satisfied.|12 months|||units on a scale||Standard Deviation|Mean
650402|NCT02056834|Secondary|Anatomical Gradings Assessed Radiographically|"The following was assessed:
depression of knee joint: presence or absence
condylar widening (enlargement of the knee joint): presence or absence
angulation; valgus/varus (abnormal outward/inward turning of the knee): presence or absence"|12 months|||participants|||Number
650403|NCT02056834|Secondary|Total Range of Motion||12 months|||participants|||Number
650404|NCT02056834|Secondary|Patients Who Reached Full Weight Bearing||12 months|||participants|||Number
650405|NCT02056834|Secondary|Absorption Rate of Calcium Phosphate Cement|Absorption of calcium phosphate cement over time was calculated from X-rays with the INFINITT program.|12 months|||percentage of absorption at 12 months||Standard Deviation|Mean
650411|NCT02056392|Primary|Change From Baseline in QTcF|Change from baseline in QTcF at 6 hours (msec)|6 hours|All patients who had evaluable pharmacodynamic data available for at least one treatment group were included in the PD analysis set||msec|Participants|95% Confidence Interval|Least Squares Mean
650412|NCT02056392|Primary|Change From Baseline in QTcF|Change from baseline in QTcF at 4 hours (msec)|4 hours|All patients who had evaluable pharmacodynamic data available for at least one treatment group were included in the PD analysis set||msec|Participants|95% Confidence Interval|Least Squares Mean
650413|NCT02056392|Primary|Change From Baseline in QTcF|Change from baseline in QTcF at 3 hours (msec)|3 hours|All patients who had evaluable pharmacodynamic data available for at least one treatment group were included in the PD analysis set||msec|Participants|95% Confidence Interval|Least Squares Mean
650414|NCT02056392|Primary|Change From Baseline in QTcF|Change from baseline in QTcF at 2 hours (msec)|2 hours|All patients who had evaluable pharmacodynamic data available for at least one treatment group were included in the PD analysis set||msec|Participants|95% Confidence Interval|Least Squares Mean
650415|NCT02056392|Primary|Change From Baseline in QTcF|Change from baseline in QTcF at 1 hour 30 min (msec)|1 hour 30 min|All patients who had evaluable pharmacodynamic data available for at least one treatment group were included in the PD analysis set||msec|Participants|95% Confidence Interval|Least Squares Mean
650416|NCT02056392|Primary|Change From Baseline in QTcF|Change from baseline in QTcF at 1 hour (msec)|1 hour|All patients who had evaluable pharmacodynamic data available for at least one treatment group were included in the PD analysis set||msec|Participants|95% Confidence Interval|Least Squares Mean
650417|NCT02056392|Primary|Change From Baseline in QTcF|Change from baseline in QTcF at 30 minutes (msec)|30 min|All patients who had evaluable pharmacodynamic data available for at least one treatment group were included in the PD analysis set||msec|Participants|95% Confidence Interval|Least Squares Mean
650418|NCT02055430|Other Pre-specified|Factors Affecting the Outcome of Each Group (Operative Time, Safety and Efficacy)|"age, site of stones, size of stones, degree of hydronephrosis
they were calculated per 45 ureterorenal units in PCN group and 90 ureterorenal units in Double J group"|1 week||||||
650419|NCT02055430|Secondary|The Number of Subsequent Interventions Needed for Clearance of Stones .|The number of subsequent interventions needed for clearance of stones after normalization of serum creatinine in relation to initial urinary drainage method using percutaneous nephrostomy or ureteric stent in children with Obstructive Anuria and Acute Renal Failure|6 months||||||
650420|NCT02055430|Primary|Complications of Each Drainage Method|"complications of initial urinary drainage using percutaneous nephrostomy or ureteric stent in children with Obstructive Anuria and Acute Renal Failure (mucosal complications, failure of insertion, slippage, fever and infection, hematuria, leakage)
complications were calculated per 45 ureterorenal units in PCN group and 90 ureterorenal units in Double J group"|1 week||||||
650421|NCT02055430|Primary|Period to Return to Normal Creatinine|"period required for normalization of serum creatinine after initial urinary drainage using percutaneous nephrostomy or ureteric stent in children with obstructive calcular anuria and Acute Renal Failure
serum creatinine was compared to normal values in matched healthy children"|1 week|||days||Standard Deviation|Mean
650422|NCT02055404|Primary|Visibility of Rotation Mark (Clearly Visible, Slightly Visible Acceptable)|"Each lens (containing 8 rotation marks and one reference mark, in total 9 marks) was assessed for visibility by 10 investigators using the following scale: N/A; Not visible; Slightly visible, not acceptable; Slightly visible, acceptable; Clearly visible; More visible than necessary. Visibility assessments were made after all marks had been evaluated. S9 Mark (test lens) functioned as a starting marker only and was not rated. The control lens was not used as a comparison, but rather as a reference for what a mark looks like on a commercial product. Visibility of Rotation Mark is reported as the percentage of assessments rating the rotation mark as Clearly visible or Slightly visible, acceptable."|Day 1|The analysis population includes all enrolled participants. Assessments from all 10 investigators were analyzed, hence sample size for each rotational mark is 30.||Percentage of assessments|||Number
650423|NCT02055352|Secondary|Change in Health Status - SGRQ-C|St George’s Respiratory Questionnaire short version questionnaire will be completed by participants. The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life)|Baseline, week 12 and week 24|Per-protocol set (PPS) included all patients in the FAS without any major protocol deviations. Major protocol deviations were defined in the validation analysis plan prior to database lock and the unblinding of the study. Patients were analyzed according to the treatment they are randomized to||Score on a scale||Standard Error|Least Squares Mean
650424|NCT02055352|Secondary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second at Week 24 (Analysis of Superiority)|Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing.|Baseline and week 24|Per-protocol set (PPS) included all patients in the FAS without any major protocol deviations. Major protocol deviations were defined in the validation analysis plan prior to database lock and the unblinding of the study. Patients were analyzed according to the treatment they are randomized to||Liters||Standard Error|Least Squares Mean
650425|NCT02055352|Secondary|Change From Baseline in Mean Daily Number of Puffs of Rescue Medication Used Over the 24 Week Treatment|A day with no rescue medication use is defined from the diary data as any day where the patient recorded no rescue medicine use during the previous 12 hours.|24 weeks|Per-protocol set (PPS) included all patients in the FAS without any major protocol deviations. Major protocol deviations were defined in the validation analysis plan prior to database lock and the unblinding of the study. Patients that were not discontinued before Visit 3 (day 28±3).||Puffs||Standard Deviation|Mean
650439|NCT02054715|Secondary|The Decision Regret Scale (DRS)|The Decision Regret Scale (DRS) is a five-item paper and pencil self-report measure that asks subjects to reflect on a particular decision and then rate each item on a Likert scale from 1 (strongly agree) to 5 (strongly disagree). A mean score for the DRS is calculated by reverse scoring the two negatively phrased items and dividing by five. The mean scores are converted to a score ranging from 0 to 100 by subtracting 1 and multiplying by 25 and higher scores represent increases in the severity of decision regret. Higher scores are worse.|Day 49-56|The population for this outcome is 192 (PE) + 173 (MP) = 365 This is defined as follow-up 2 (Day 49-56).||percentage of DRS (0 - 100)||Standard Error|Mean
662136|NCT01828476|Secondary|Progression Free Survival||5 years|Study was terminated early and insufficient data were collected to assess this outcome measure.|||||
650426|NCT02055352|Secondary|Change in Health Status - mMRC|Modified Medical Research Council scale (mMRC) questionnaire will be completed by participants. 0 Not troubled with breathlessness except with strenuous exercise; 1 Troubled by shortness of breath when hurrying on the level or walking up a slight hill; 2 Walks slower than people of the same age on the level because of breathlessness or has to stop for breath when walking at own pace on the level; 3 Stops for breath after walking about 100 yards or after a few minutes on the level; 4 Too breathless to leave the house or breathless when dressing or undressing|Baseline, week 12 and week 24|Per-protocol set (PPS) included all patients in the FAS without any major protocol deviations. Major protocol deviations were defined in the validation analysis plan prior to database lock and the unblinding of the study. Patients were analyzed according to the treatment they are randomized to||Score on a scale||Standard Error|Least Squares Mean
650427|NCT02055352|Primary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (Non-inferiority Analysis).|Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.|Baseline and week 12|Per-protocol set (PPS) included all patients in the FAS without any major protocol deviations. Major protocol deviations were defined in the validation analysis plan prior to database lock and the unblinding of the study. Patients were analyzed according to the treatment they are randomized to||Liters||Standard Error|Least Squares Mean
650428|NCT02054910|Secondary|% of Subjects in Each Group That Are Employed at 6 Months Post Procedure.|Subjects will be asked about employment at 6 months post procedure|baseline to 6 months|All subjects were lost to follow up by 6 months; the secondary endpoint was not collected for any subject|||||
650429|NCT02054910|Secondary|Mean Number of Times Subjects in Each Group Accessed the Health Care System Within 6 Months Post Procedure|The number of times each subject accessed the health care system will be collected, and then the mean will be calculated for each group|baseline to 6 months|All subjects were lost to follow up by 6 months; since everyone dropped out at different times before the 6 month point, the data would not be evaluable.|||||
650430|NCT02054910|Secondary|Mean Mental State Between Groups Using the Beck's Depression Index at 6 Months.|"The Beck's Depression scale was used to indicate subject's depression:
0–9: indicates minimal depression 10–18: indicates mild depression 19–29: indicates moderate depression 30–63: indicates severe depression."|baseline to 6 months|All subjects were lost to follow up by 6 months; the secondary endpoint was not collected for any subject|||||
650431|NCT02054910|Secondary|Number of Subject in Each Group Requiring Administration of Narcotics During 6 Months Post Baseline|the number of subjects receiving a narcotic drug during the 6 months post baseline will be noted.|baseline to 6 months|All subjects were lost to follow up by 6 months; the secondary endpoint was not collected for any subject|||||
650432|NCT02054910|Secondary|Mean Quality of Life Score Between Each Group at 6 Months|The American Chronic Pain Association, Quality of Life Score will be used. This scoring ranges from 0 (Stay in bed all day Feel hopeless and helpless about life - non-functioning) to 10 (Go to work/volunteer each day Normal daily activities each day Have a social life outside of work Take an active part in family life - normal life).|6 months post baseline|All subjects were lost to follow up by 6 months; the secondary endpoint was not collected for any subject|||||
650433|NCT02054910|Primary|Change in Pain Response Over a 6 Month Period of Time Using the VAS Score|Pain scores will be assessed by comparing the mean number change using the Visual Analog Scale (VAS) from baseline to 6 month. The scale is 10 - 0, with 10 being agonizing pain and 0 being no pain.|baseline to 6 months|All subjects were lost to follow up by 6 months; the primary endpoint was not collected for any subject|||||
650434|NCT02054754|Other Pre-specified|Pharmacodynamic Biomarker Assessment|Blood samples taken and analysed for the purposes of the identification and quantification of pharmacodynamic biomarkers pre-dose and at several points after dosing.|Pre-dose, 1, 6 and 24 hours post dose||||||
650435|NCT02054754|Secondary|Area Under the Curve of the Compound Dexanabinol (ETS2101) From Pre-dose up to 48 Hours Post Dose|Pharmacokinetic parameters will be assessed in a blinded fashion at the end of each cohort, prior to dose escalation.|Pre-dose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16,24,36,48 hours post dose|||ng.h/mL||Standard Deviation|Mean
650436|NCT02054754|Primary|Safety and Tolerability Based on the Number of Participants With Adverse Events and Comparison of Baseline and Post Dose Parameters|"Safety and tolerability based on the number of participants with adverse events. Assessment and comparison to baseline of the following:
Physical exam
Safety bloods and urinalysis
12-lead ECG
Vital signs"|Participants will be followed until follow up visit, 6-11 days after dosing|||participants|||Number
650437|NCT02054715|Other Pre-specified|To Explore the Effects of Intervention Assignment on Clinical Trial Participation.|Given the ethical perspective that patients have a right to make autonomous decisions about clinical trial participation, no hypothesis is offered about the effect of intervention assignment on clinical trial participation rates. To conduct the exploratory analysis regarding the effects of intervention assignment on clinical trial participation, data for all patients offered participation in a therapeutic clinical trial will be entered into a 2 (Intervention: MP or PE) x 2 (Clinical Trial Participation: Yes or No/Still Deciding) contingency table and analyzed using either a Fisher exact test or chi-square test as appropriate.|Day 49-56|The population for this outcome is 192 (PE) + 170 (MP) = 362 Note: There were 3 individuals (MP) who did not answer this question. This is defined as follow-up 2 (Day 49-56).||Participants|||Count of Participants
650438|NCT02054715|Secondary|The Decisional Conflict Scale (DCS)|The Decisional Conflict Scale (DCS) is a valid and reliable 16-item self-report measure that assesses the extent to which respondents experience certainty, satisfaction, and confidence following a health care decision. In the present study, it will be keyed to the decision about therapeutic clinical trial participation. Instructions given to respondents include asking them to reflect on the decisions have just made or are about to make and to respond to statements in the DCS using a five-point Likert scale. Responses to each statement are scored from 1 (strongly agree) to 5 (strongly disagree), with negative statements having reverse scoring; thus high scores indicate higher decisional conflict.|Day 49-56|The population for this outcome is 192 (PE) + 173 (MP) = 365 This is defined as follow-up 2 (Day 49-56).||Percentage of DCS (0 - 100)||Standard Error|Mean
650453|NCT02054572|Secondary|Number of Participants With Anti-etelcalcetide Antibodies|The presence of anti-etelcalcetide antibodies was assessed and confirmed using a dual-flow cell biosensor immunoassay at baseline (day -1) and at the end of study visit (day 39).|Day -1 and day 39|Participants who received any amount of [¹⁴C]etalcalcetide||participants|||Number
650440|NCT02054715|Primary|Preparedness for Decision Making About Clinical Trial Participation, Measured Using Scores From the Preparation for Decision Making Scale|Preparation for Decision Making Scale (PDMS) is a valid and reliable 10-item self-report measure for which respondents rate the usefulness of materials they were provided in preparing them to communicate with their health care provider and make a health care decision. Each item is scored 1 to 5 where 1=Not at All, 2=A Little, 3=Somewhat, 4=Quite a Bit, 5=A Great Deal. Larger number is better. All 10 scores are summed, then divided by 10; The result - 1 is then multiplied by 25 and we have a range from 0 (less prepared) - 100 (most prepared).|Day 3 to 7|There were 219 (PE) + 199 (MP) = 418 at Baseline. The population for this outcome is 211 (PE) + 192 (MP) = 403 This is defined as follow-up 1 (Day 3-7).||percentage of PDMS (0 - 100)||Standard Error|Mean
650441|NCT02054702|Secondary|Change From Baseline to Week 6 in Barratt Impulsiveness Scale (BIS-11 Item) Total Score|The BIS-11, a subject-rated scale designed to assess impulsive personality traits, was administered at the baseline and Week 6 visits. The BIS-11 consisted of 30 items scored on a 4-point scale ranging from 1 (rarely/never) to 4 (almost always/always). The scores provided information to assess 6 first-order factors (attention, motor, self-control, cognitive complexity, perseverance, and cognitive instability impulsiveness) and 3 second-order factors (motor impulsiveness, nonplanning impulsiveness, and attentional impulsiveness). The total score ranged from 30 to 120, higher scores indicate better personality trait.|Baseline to Week 6|All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. Analysis was performed on the LOCF dataset.||Units on a scale||95% Confidence Interval|Least Squares Mean
650442|NCT02054702|Secondary|Change From Baseline to Week 6 in Specific Levels of Functioning Scale (SLOF) Total Score|"The SLOF questionnaire used in this trial consisted of 30 items grouped into 4 areas: interpersonal relationships, social acceptability, activities, and work skill. The SLOF correlates with a subject’s quality of life. Each of the questions in the domains is rated on a 5-point Likert scale ranging from 1 not well at all to 5 very well. The possible total score range for SLOF is from 30 to 150, higher score indicating better overall functioning of the participant."|Baseline to Week 6|All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. Analysis was performed on the LOCF dataset.||Units on a scale||95% Confidence Interval|Least Squares Mean
650443|NCT02054702|Secondary|Response Rate by Study Week|The response rate was defined as reduction of ≥30% from Baseline in PANSS Total Score or CGI-I score of of 1 (very much improved) or 2 (much improved).|Baseline to Week 6|All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. Analysis was performed on the LOCF dataset.||percentage of participants|||Number
650444|NCT02054702|Secondary|Mean Change in Clinical Global Impression–Improvement (CGI-I) Score at Week 6|The efficacy of trial medication was rated for each participant using the CGI-I. The study physician would rate the participant's total improvement whether or not it is due entirely to drug treatment. All responses were compared to the participant's condition at Baseline prior to the first dose of double-blind study medication. Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.|Baseline to Week 6|All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. Analysis was performed on the LOCF dataset.||Units on a scale||Standard Deviation|Mean
650445|NCT02054702|Secondary|Mean Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score|The severity of illness for each participant was rated using the CGI-S. To perform this assessment, the study physician answered the following question: “Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?” Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.|Baseline to Week 6|All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. The efficacy analyses were performed by fitting a MMRM analysis with an unstructured variance covariance structure.||Units on a scale||Standard Error|Least Squares Mean
650446|NCT02054702|Secondary|Change From Baseline in Cognitive Test Battery Scores of One Card Learning Task|The cognitive test battery contains 8-tasks, including the Detection Task (DET, speed of processing), Identification Task (IDN, attention/vigilance), One Card Learning Task (OCL, visual learning), One-back Memory Task (ONB, working memory), Two Back Task (TWOB, working memory), the Groton Maze Learning Task (GML, problem solving/error monitoring), Social Emotional Cognition Task (SECT, social cognition), International shopping List Task (ISL, verbal learning and memory). The results of each domain on the cognitive test battery were calculated into Z-scores, where the healthy control mean was set to zero and the standard deviation to 1. A composite score was generated, with higher values representing better cognitive performance. The composite score is then the mean of z-scores for appropriate tasks where z-score = − 1 × z-score for DET, GML, IDN and ONB to correct for the direction of improvement.|Baseline to Week 6|All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. The efficacy analyses were performed by fitting a MMRM analysis with an unstructured variance covariance structure.||z-score||Standard Error|Least Squares Mean
650454|NCT02054572|Secondary|Number of Participants With Adverse Events|A treatment-related adverse event (TRAE) is any adverse event (AE) that per investigator review has a reasonable possibility of being caused by the investigational product.|From first dose of etelcalcetide to day 39|Participants who received any amount of [¹⁴C]etalcalcetide||participants|||Number
650455|NCT02054572|Secondary|Hemodialysis Extraction Ratio for Etelcalcetide During Hemodialysis on Day 4||Day 4 within 10 minutes after the start of hemodialysis, at 2 hours after the start of hemodialysis, and within 10 minutes before the end of hemodialysis.|Participants who received any part of the [¹⁴C]etelcalcetide dose and had measurable concentrations in at least 1 sample were included in the analysis.||ratio||Standard Deviation|Mean
650562|NCT02051426|Primary|Change in Visual Analogue Scale (VAS) of Anxiety - From Baseline to 2 Hours|The subject was asked to point on the VAS scale according to his anxiety level. VAS anxiety scale 0 to 10 ( 0 [no anxiety] to 10 [maximum anxiety] ).|Baseline, 2 hours post intervention|||units on a scale||Standard Deviation|Mean
650447|NCT02054702|Secondary|Change From Baseline in Cognitive Test Battery Scores of Identification Task|The cognitive test battery contains 8-tasks, including the Detection Task (DET, speed of processing), Identification Task (IDN, attention/vigilance), One Card Learning Task (OCL, visual learning), One-back Memory Task (ONB, working memory), Two Back Task (TWOB, working memory), the Groton Maze Learning Task (GML, problem solving/error monitoring), Social Emotional Cognition Task (SECT, social cognition), International shopping List Task (ISL, verbal learning and memory). The results of each domain on the cognitive test battery were calculated into Z-scores, where the healthy control mean was set to zero and the standard deviation to 1. A composite score was generated, with higher values representing better cognitive performance. The composite score is then the mean of z-scores for appropriate tasks where z-score = − 1 × z-score for DET, GML, IDN and ONB to correct for the direction of improvement.|Baseline to Week 6|All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. The efficacy analyses were performed by fitting a MMRM analysis with an unstructured variance covariance structure.||z-score||Standard Error|Least Squares Mean
650448|NCT02054702|Secondary|Change From Baseline in Cognitive Test Battery Scores of Detection Task|The cognitive test battery contains 8-tasks, including the Detection Task (DET, speed of processing), Identification Task (IDN, attention/vigilance), One Card Learning Task (OCL, visual learning), One-back Memory Task (ONB, working memory), Two Back Task (TWOB, working memory), the Groton Maze Learning Task (GML, problem solving/error monitoring), Social Emotional Cognition Task (SECT, social cognition), International shopping List Task (ISL, verbal learning and memory). The results of each domain on the cognitive test battery were calculated into Z-scores, where the healthy control mean was set to zero and the standard deviation to 1. A composite score was generated, with higher values representing better cognitive performance. The composite score is then the mean of z-scores for appropriate tasks where z-score = − 1 × z-score for DET, GML, IDN and ONB to correct for the direction of improvement.|Baseline to Week 6|All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. The efficacy analyses were performed by fitting a MMRM analysis with an unstructured variance covariance structure.||z-score||Standard Error|Least Squares Mean
650449|NCT02054702|Secondary|Change From Baseline in Cognitive Test Battery Scores of Groton Maze Learning (GML)|The cognitive test battery contains 8-tasks, including the Detection Task (DET, speed of processing), Identification Task (IDN, attention/vigilance), One Card Learning Task (OCL, visual learning), One-back Memory Task (ONB, working memory), Two Back Task (TWOB, working memory), the Groton Maze Learning Task (GML, problem solving/error monitoring), Social Emotional Cognition Task (SECT, social cognition), International shopping List Task (ISL, verbal learning and memory). The results of each domain on the cognitive test battery were calculated into Z-scores, where the healthy control mean was set to zero and the standard deviation to 1. A composite score was generated, with higher values representing better cognitive performance. The composite score is then the mean of z-scores for appropriate tasks where z-score = − 1 × z-score for DET, GML, IDN and ONB to correct for the direction of improvement.|Baseline to Week 6|All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment.||z-score||Standard Error|Least Squares Mean
650450|NCT02054702|Secondary|Change From Baseline in Cognitive Test Battery of Early Phase Battery Score|The cognitive test battery contains 8-tasks, including the Detection Task (DET, speed of processing), Identification Task (IDN, attention/vigilance), One Card Learning Task (OCL, visual learning), One-back Memory Task (ONB, working memory), Two Back Task (TWOB, working memory), the Groton Maze Learning Task (GML, problem solving/error monitoring), Social Emotional Cognition Task (SECT, social cognition), International shopping List Task (ISL, verbal learning and memory). A composite score was generated, with higher values representing better cognitive performance. The composite score is then the mean of z-scores for appropriate tasks where z-score = − 1 × z-score for DET, GML, IDN and ONB to correct for the direction of improvement. The cognitive test early phase battery was analyzed; tasks included Groton Maze Learning Task, Detection Task, Identification Task, and One Card Learning Task.|Baseline to Week 6|All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. The efficacy analyses were performed by fitting a MMRM analysis with an unstructured variance covariance structure.||z-score||Standard Error|Least Squares Mean
650451|NCT02054702|Secondary|Change From Baseline in Cognitive Test Battery Composite Score|The cognitive test battery contains 8-tasks, including the Detection Task (DET, speed of processing), Identification Task (IDN, attention/vigilance), One Card Learning Task (OCL, visual learning), One-back Memory Task (ONB, working memory), Two Back Task (TWOB, working memory), the Groton Maze Learning Task (GML, problem solving/error monitoring), Social Emotional Cognition Task (SECT, social cognition), International shopping List Task (ISL, verbal learning and memory). The results of each domain on the cognitive test battery were calculated into Z-scores, where the healthy control mean was set to zero and the standard deviation to 1. A composite score was generated, with higher values representing better cognitive performance. The composite score is then the mean of z-scores for appropriate tasks where z-score = − 1 × z-score for DET, GML, IDN and ONB to correct for the direction of improvement.|Baseline to Week 6|All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. The efficacy analyses were performed by fitting a MMRM analysis with an unstructured variance covariance structure.||z-score||Standard Error|Least Squares Mean
650452|NCT02054702|Primary|Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline to Week 6|All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. The efficacy analyses were performed by fitting a mixed model repeated measures (MMRM) analysis with an unstructured variance covariance structure.||Units on a scale||Standard Error|Least Squares Mean
655249|NCT01953328|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
650456|NCT02054572|Secondary|Hemodialysis Clearance of Etelcalcetide During Hemodialysis on Day 4||Day 4 within 10 minutes after the start of hemodialysis, at 2 hours after the start of hemodialysis, and within 10 minutes before the end of hemodialysis.|Participants who received any part of the [¹⁴C]etelcalcetide dose and had measurable concentrations in at least 1 sample were included in the analysis.||mL/hr||Standard Deviation|Mean
650457|NCT02054572|Secondary|Area Under the Curve From Time Zero to 10 Days Post-dose (AUC10d) of Etelcalcetide||Samples were collected from pre-dose on day 1 to day 39; additional samples were collected at 3 consecutive hemodialysis sessions from days 129 -148 and approximately 1 month later at an additional 3 consecutive hemodialysis sessions from days 157-176.|Participants who received any part of the [¹⁴C]etelcalcetide dose and had measurable concentrations in at least 1 sample were included in the analysis.||day*ng/mL||Standard Deviation|Mean
650458|NCT02054572|Secondary|Area Under the Curve From Time Zero to 3 Days Post-dose (AUC3d) of Etelcalcetide||Samples were collected from pre-dose on day 1 to day 39; additional samples were collected at 3 consecutive hemodialysis sessions from days 129 -148 and approximately 1 month later at an additional 3 consecutive hemodialysis sessions from days 157-176.|Participants who received any part of the [¹⁴C]etelcalcetide dose and had measurable concentrations in at least 1 sample were included in the analysis.||day*ng/mL||Standard Deviation|Mean
650459|NCT02054572|Secondary|Last Observed Plasma Concentration (Clast) of Etelcalcetide||Samples were collected from pre-dose on day 1 to day 39; additional samples were collected at 3 consecutive hemodialysis sessions from days 129 -148 and approximately 1 month later at an additional 3 consecutive hemodialysis sessions from days 157-176.|Participants who received any part of the [¹⁴C]etelcalcetide dose and had measurable concentrations in at least 1 sample were included in the analysis.||ng/mL||Full Range|Median
650460|NCT02054572|Secondary|Time to Last Observed Plasma Concentration of Etelcalcetide||Samples were collected from pre-dose on day 1 to day 39; additional samples were collected at 3 consecutive hemodialysis sessions from days 129 -148 and approximately 1 month later at an additional 3 consecutive hemodialysis sessions from days 157-176.|Participants who received any part of the [¹⁴C]etelcalcetide dose and had measurable concentrations in at least 1 sample were included in the analysis.||days||Full Range|Median
650461|NCT02054572|Secondary|Maximum Observed Concentration (Cmax) of Etelcalcetide||Samples were collected from pre-dose on day 1 to day 39; additional samples were collected at 3 consecutive hemodialysis sessions from days 129 -148 and approximately 1 month later at an additional 3 consecutive hemodialysis sessions from days 157-176.|Participants who received any part of the [¹⁴C]etelcalcetide dose and had measurable concentrations in at least 1 sample were included in the analysis.||ng/mL||Standard Deviation|Mean
650462|NCT02054572|Secondary|Time to Maximum Observed Concentration (Tmax) of Etelcalcetide|Etelcalcetide plasma concentrations were determined by liquid chromatography-tandem mass spectrometry (LC-MS/MS).|Samples were collected from pre-dose on day 1 to day 39; additional samples were collected at 3 consecutive hemodialysis sessions from days 129 -148 and approximately 1 month later at an additional 3 consecutive hemodialysis sessions from days 157-176.|Participants who received any part of the [¹⁴C]etelcalcetide dose and had measurable concentrations in at least 1 sample were included in the analysis.||minutes||Full Range|Median
650463|NCT02054572|Primary|Area Under the Venous Plasma Concentration-time Curve Obtained During Hemodialysis on Day 4 for Etelcalcetide|Etelcalcetide plasma concentrations were determined by liquid chromatography-tandem mass spectrometry (LC-MS/MS).|Day 4 within 10 minutes after the start of hemodialysis, at 2 hours after the start of hemodialysis, and within 10 minutes before the end of hemodialysis.|Participants who received any part of the [¹⁴C]etelcalcetide dose and had measurable concentrations in at least 1 sample were included in the analysis.||ng*day/mL||Standard Deviation|Mean
650464|NCT02054572|Primary|Area Under the Arterial Plasma Concentration-time Curve Obtained During Hemodialysis on Day 4 for Etelcalcetide|Etelcalcetide plasma concentrations were determined by liquid chromatography-tandem mass spectrometry (LC-MS/MS).|Day 4 within 10 minutes after the start of hemodialysis, at 2 hours after the start of hemodialysis, and within 10 minutes before the end of hemodialysis.|Participants who received any part of the [¹⁴C]etelcalcetide dose and had measurable concentrations in at least 1 sample were included in the analysis.||ng*day/mL||Standard Deviation|Mean
650465|NCT02054572|Primary|Area Under the Curve From Time Zero to 10 Days Post-dose (AUC10d) of [¹⁴C]Etelcalcetide-derived Radioactivity in Plasma||Samples were collected from pre-dose on day 1 to day 39; additional samples were collected at 3 consecutive hemodialysis sessions from days 129 -148 and approximately 1 month later at an additional 3 consecutive hemodialysis sessions from days 157-176.|Participants who received any part of the [¹⁴C]etelcalcetide dose and had measurable concentrations in at least 1 sample were included in the analysis.||day*ng-eq/mL||Standard Deviation|Mean
650466|NCT02054572|Primary|Area Under the Curve From Time Zero to 3 Days Post-dose (AUC3d) of [¹⁴C]Etelcalcetide-derived Radioactivity in Plasma||Samples were collected from pre-dose on day 1 to day 39; additional samples were collected at 3 consecutive hemodialysis sessions from days 129 -148 and approximately 1 month later at an additional 3 consecutive hemodialysis sessions from days 157-176.|Participants who received any part of the [¹⁴C]etelcalcetide dose and had measurable concentrations in at least 1 sample were included in the analysis.||day*ng-eq/mL||Standard Deviation|Mean
650467|NCT02054572|Primary|Apparent Terminal Half-life (T½) of [¹⁴C]Etelcalcetide-derived Radioactivity in Plasma||Samples were collected from pre-dose on day 1 to day 39; additional samples were collected at 3 consecutive hemodialysis sessions from days 129 -148 and approximately 1 month later at an additional 3 consecutive hemodialysis sessions from days 157-176.|Participants who received any part of the [¹⁴C]etelcalcetide dose and had measurable concentrations in at least 1 sample were included in the analysis.||days||Standard Deviation|Mean
650468|NCT02054572|Primary|Last Observed Plasma Concentration (Clast) of [¹⁴C]Etelcalcetide-derived Radioactivity in Plasma||Samples were collected from pre-dose on day 1 to day 39; additional samples were collected at 3 consecutive hemodialysis sessions from days 129 -148 and approximately 1 month later at an additional 3 consecutive hemodialysis sessions from days 157-176.|Participants who received any part of the [¹⁴C]etelcalcetide dose and had measurable concentrations in at least 1 sample were included in the analysis.||ng-eq/mL||Full Range|Median
650500|NCT02053493|Secondary|Improvement in Daily Activity - Hours Active Per Day (Phase II)|To evaluate whether isosorbide mononitrate in comparison to placebo improves daily activity as measured by Hours active per day during maximal dose of study drug|11-12 weeks|Participants with usable data included in the results||Hours/day||Standard Deviation|Mean
650469|NCT02054572|Primary|Time to Last Observed Plasma Concentration of [¹⁴C]Etelcalcetide-derived Radioactivity in Plasma||Samples were collected from pre-dose on day 1 to day 39; additional samples were collected at 3 consecutive hemodialysis sessions from days 129 -148 and approximately 1 month later at an additional 3 consecutive hemodialysis sessions from days 157-176.|Participants who received any part of the [¹⁴C]etelcalcetide dose and had measurable concentrations in at least 1 sample were included in the analysis.||days||Full Range|Median
650470|NCT02054572|Primary|Maximum Observed Concentration (Cmax) of [¹⁴C]Etelcalcetide-derived Radioactivity in Plasma||Samples were collected from pre-dose on day 1 to day 39; additional samples were collected at 3 consecutive hemodialysis sessions from days 129 -148 and approximately 1 month later at an additional 3 consecutive hemodialysis sessions from days 157-176.|Participants who received any part of the [¹⁴C]etelcalcetide dose and had measurable concentrations in at least 1 sample were included in the analysis.||ng-eq/mL||Standard Deviation|Mean
650471|NCT02054572|Primary|Time to Maximum Observed Concentration (Tmax) of [¹⁴C]Etelcalcetide-derived Radioactivity in Plasma|Total radioactive counts in plasma was determined by accelerator mass spectrometry (AMS).|Samples were collected from pre-dose on day 1 to day 39; additional samples were collected at 3 consecutive hemodialysis sessions from days 129 -148 and approximately 1 month later at an additional 3 consecutive hemodialysis sessions from days 157-176.|Participants who received any part of the [¹⁴C]etelcalcetide dose and had measurable concentrations in at least 1 sample were included in the analysis.||minutes||Full Range|Median
650472|NCT02054572|Primary|Cumulative Excretion of Radioactivity|The total radioactivity in excreta (urine and feces) or dialysate and dialysis membrane is expressed as a percentage of the total radioactive [¹⁴C] administered (dose). Total radioactive counts in dialysate, dialyzer, feces, and urine were determined by accelerator mass spectrometry (AMS). Radioactivity excreted during non-sampled days was estimated by interpolation and extrapolation of the measured data.|Day 1 to day 176|Participants who received any amount of [¹⁴C]etelcalcetide with available excretion data||Percentage of administered dose||Standard Deviation|Mean
650473|NCT02054481|Secondary|Time to Loss of PASI50 Response|Time to loss of PASI50 response.|From first drug administration until end of follow-up period, up to 48 weeks|FAS||Days||95% Confidence Interval|Median
650474|NCT02054481|Secondary|Achievement of sPGA Clear or Almost Clear at Week 12|"Percentage of participants who achieved static Physician Global Assessment (sPGA) clear or almost clear at Week 12.
sPGA is assessed on a six-point scale from 0 (clear) to 5 (severe)."|Week 12|FAS||Percentage of participants||95% Confidence Interval|Number
650475|NCT02054481|Secondary|Percentage Change in PASI Score From Baseline at Week 12|"Percentage change in Psoriasis Area and Severity Index (PASI) from baseline at Week 12.
PASI score ranges from 0 (best) to 72 (worst)."|Baseline and Week 12|FAS including patients with available data.||Percentage of PASI score||Standard Deviation|Mean
650476|NCT02054481|Secondary|Achievement of PASI90 at Week 24|"Percentage of participants who achieved PASI90 at Week 24.
PASI score ranges from 0 (best) to 72 (worst)."|Week 24|FAS||Percentage of participants||95% Confidence Interval|Number
650477|NCT02054481|Secondary|Achievement of ≥50% Reduction From Baseline in PASI Score (PASI50) at Week 12|"Percentage of participants who achieved ≥50% reduction from baseline in Psoriasis Area and Severity Index score (PASI50) at Week 12.
PASI score ranges from 0 (best) to 72 (worst)."|Baseline and Week 12|FAS||Percentage of participants||95% Confidence Interval|Number
650478|NCT02054481|Secondary|Achievement of 100% Reduction From Baseline in PASI Score (PASI100) at Week 12|"Percentage of participants who achieved 100% reduction from baseline in Psoriasis Area and Severity Index score (PASI100) at Week 12.
PASI score ranges from 0 (best) to 72 (worst)."|Baseline and Week 12|FAS||Percentage of participants||95% Confidence Interval|Number
650479|NCT02054481|Secondary|Achievement of ≥75% Reduction From Baseline in PASI Score (PASI75) at Weeks 12 and 24|"Percentage of participants who achieved ≥75% reduction from baseline in Psoriasis Area and Severity Index score (PASI75) at Weeks 12 and 24.
PASI score ranges from 0 (best) to 72 (worst)."|Baseline, Week 12 and Week 24|FAS||Percentage of participants||95% Confidence Interval|Number
650480|NCT02054481|Primary|Achievement of ≥90% Reduction From Baseline PASI Score (PASI90) at Week 12|"Percentage of participants who achieved ≥90% reduction from baseline in Psoriasis Area and Severity Index score (PASI90) at Week 12.
PASI score ranges from 0 (best) to 72 (worst)."|Baseline and Week 12|Full Analysis Set (FAS) which included all randomised patients who received at least 1 dose of trial medication and was based on the randomised treatment.||Percentage of participants||95% Confidence Interval|Number
650481|NCT02054325|Secondary|The Safety of the Treatment: Mean Percent of Skin Hyperpigmentation Two Months After Treatment|"Skin hyperpigmentation was defined as a brownish hue stain superimposing the previous treated vein site (by visual photographic analyses). Skin hyperpigmentation was firstly evaluated according to its occurence and labeled as Yes or No. Afterwards, when there was stain in the previous treated area, a line was drawn on the stain with Image J software , and the Mean Percent of Skin Hyperpigmentation was proportionaly compared with length of vein treated, previuos mesuread (mean and SD)."|Two months after treatment.|||Percent of Skin Hyperpigmentation||Standard Deviation|Mean
650482|NCT02054325|Primary|Efficacy in Treating Reticular Veins by Photographs: Mean Percent Reticular Vein Disappearance Two Months After Treatment.|Photographs were performed pretreatment and two months after the treatment, these were analyzed for efficacy in treat reticular veins by two blind analyzers objectively with measurement through the use of free software ImageJ.|Mean Percent of reticular vein disappearance two months after treatment|||% of Reticular Veins that Disappeared||Standard Deviation|Mean
650483|NCT02053610|Secondary|European Organization for Research and Treatment of Cancer (EORTC) QLQ-CLL16 Questionnaire|EORTC Quality of Life Questionnaire (QLQ-CLL16) module was used to assess patient-reported outcomes and symptom burden. The QLQ-CLL16 module includes three multi-item scales assessing fatigue (2 items), treatment side effects and disease symptoms (8 items), infection (4 items) and two single item scales on social activities and future health worries. Final scores are transformed such that they range from 0 − 100, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms, with changes of 5 − 10 points considered to be of minimally important difference to participants. A positive change from Baseline indicated improvement.|Baseline and Cycle 4 Day 1 (Cy4D1)|ITT population. Here, n signifies the number of participants who were evaluated for specified category.||unit on a scale||Standard Deviation|Mean
662137|NCT01828476|Secondary|Time to PSA Progression||5 years|Study was terminated early and insufficient data were collected to assess this outcome measure.|||||
650484|NCT02053610|Secondary|European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire|The EORTC Quality of Life Questionnaire (QLQ-C30) was used to assess patient-reported outcomes (PRO) and symptom burden. The QLQ-C30 contains 30 items including the functional scales of physical functioning (5 items), role functioning (2 items), emotional functioning (4 items), cognitive functioning (2 items), social functioning (2 items) and symptom scales including fatigue (3 items), nausea and vomiting (2 items), and pain (4 items) and six single item scales on dyspnea, sleep disturbance, appetite loss, constipation, diarrhea and financial impact. Final scores are transformed such that they range from 0 − 100, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms, with changes of 5 − 10 points considered to be of minimally important difference to participants. A positive change from Baseline indicated improvement.|Baseline and Cycle 4 Day 1 (Cy4D1)|ITT population. Here, n signifies the number of participants who were evaluated for specified category.||unit on a scale||Standard Deviation|Mean
650485|NCT02053610|Secondary|Time to Re-Treatment/New-antileukemic Therapy|Time to re-treatment/new anti-leukemic therapy was defined as time between the date of randomization and the date of first intake of re-treatment or new anti-leukemic therapy.|Randomization to clinical cutoff (median observation 39 months)|ITT population included all randomized participants. Participants who were reported as not having started re-treatment or new anti−leukemic therapy were censored at the last visit date they were assessed with regard to start of new treatment or the date of death.||months||95% Confidence Interval|Median
650486|NCT02053610|Secondary|Percentage of Participants With Molecular Remission at the End of Treatment|Molecular remission was defined as a minimal residual disease (MRD)-negative result at the end of treatment (assessment that occurred between 56 days and 6 months of last treatment). Molecular remission was assessed for all patients using a blood sample. Additionally, a bone marrow sample was obtained from patients whom the investigator assumed to have a complete response, consistent with the IWCLL guidelines. A combined analysis of blood and bone marrow results was conducted. A patient was considered MRD negative if result was less than 1 chronic lymphocytic leukemia (CLL) cell in 10000 leukocytes (MRD value < 0.0001) based on the method of allele specific polymerase chain reaction (ASO-PCR).|Randomization to clinical cutoff (median observation 39 months)|Participants from the ITT population, all randomized participants, with data available for analysis. Participants who had not reached the 3-month follow-up visit at the time of the clinical cut-off were excluded from analysis.||percentage of participants||95% Confidence Interval|Number
650487|NCT02053610|Secondary|Duration of Response|Duration of Response was defined as the date the response [either Complete Response (CR) or Partial Response (PR)] was first recorded until the date of Disease Progression or death due to any cause. Response was assessed according IWCLL guidelines.|Randomization to clinical cutoff (median observation 39 months)|Participants from the ITT population, all randomized participants, with response.||months||95% Confidence Interval|Median
650488|NCT02053610|Secondary|Overall Survival|Overall Survival (OS) was defined as the time between the date of randomization and the date of death due to any cause.|Randomization to clinical cutoff (median observation 39 months)|ITT population included all randomized participants. Participants who were not reported as having died at the time of the analysis were censored at the date when they were last known to be alive.||months||95% Confidence Interval|Median
650489|NCT02053610|Secondary|Event Free Survival|Event-free survival (EFS) was defined as the time between date of randomization and the date of disease progression/relapse, death, or start of a new anti-leukemic therapy. Progressive disease as per IWCLL criteria required at least one of the following: ≥50% increase in the absolute number of lymphocytes, appearance of new palpable lymph nodes (>15 mm in longest diameter) or any new extra nodal lesion, ≥50% increase in the longest diameter of any previous site of clinically significant lymphadenopathy, ≥50% increase in the enlargement of the liver and/or spleen, Transformation to a more aggressive histology or After treatment, the progression of any cytopenia (a decrease of hemoglobin levels >20 g/L or <10 g/dL or a decrease of platelet counts >50% or <100 x 10^9/L or by a decrease of neutrophil counts >50% or <1.0 x 10^9/L).|Randomization to clinical cutoff (median observation 39 months)|ITT population included all randomized participants. Participants were censored at the date of last tumor assessment. In cases where no tumor assessment is available, participants were censored at the date of randomization plus one day.||months||95% Confidence Interval|Median
650490|NCT02053610|Secondary|Percentage of Participants With Best Overall Response [Time Frame: Randomization to Clinical Cutoff (Median Observation 14.2 Months)]|Best overall response according to IWCLL guidelines was defined as the percentage of patients with CR, CRi, PR or nodular Partial Response (nPR). CR required all of the following: Peripheral blood lymphocytes below 4 x 10^9/L, Absence of significant lymphadenopathy, No hepatomegaly, No splenomegaly, Absence of disease, Blood counts above the following values (Neutrophils >1.5 x 10^9/L, Platelets >100 x 10^9/L, Hemoglobin >11g/dL) and Bone marrow at least normocellular for age. CRi was CR with incomplete bone marrow recovery. PR required the following for at least 2 months from end of treatment: ≥50% decrease in peripheral blood lymphocyte count from the pre-treatment value AND Either a ≥ 50% reduction in lymphadenopathy OR ≥50% reduction of liver enlargement OR ≥50% reduction of spleen enlargement PLUS at least one of the following: Neutrophils >1.5 x 10^9/ or ≥50% increase, Platelets >100 x 10^9/L or ≥50% increase, Hemoglobin 11 g/dL or ≥50% increase.|Randomization to clinical cutoff (median observation 39 months)|Participants from the ITT population, all randomized participants, with data available for analysis. Participants who had not reached the 3-month follow-up visit at the time of the clinical cut-off were excluded from analysis.||percentage of participants||95% Confidence Interval|Number
650501|NCT02053493|Secondary|Improvement in Daily Activity - Hours Active Per Day (Phase I)|To evaluate whether isosorbide mononitrate in comparison to placebo improves daily activity as measured by Hours active per day during maximal dose of study drug|5-6 weeks|Participants with usable data included in the results||Hours/day||Standard Deviation|Mean
650502|NCT02053493|Secondary|N-terminal Pro-B-type Natriuretic Peptide Level (Phase II)|To evaluate whether isosorbide mononitrate improves natriuretic peptide levels in comparison to placebo|Week 13|Participants with usable data included in the results||pg/mL||Standard Deviation|Mean
650503|NCT02053493|Secondary|N-terminal Pro-B-type Natriuretic Peptide Level (Phase I)|To evaluate whether isosorbide mononitrate improves natriuretic peptide levels in comparison to placebo|Week 7|Participants with usable data included in the results||pg/mL||Standard Deviation|Mean
662323|NCT01824446|Primary|AUC 0→∞ Whole Blood Total Radioactivity of Radiolabelled SSP-004184||Up to 288 hours post-dose|PAS||ng equivalents*hr/g||Standard Deviation|Mean
650491|NCT02053610|Secondary|Percentage of Participants With End of Treatment Response (EOTR)|EOTR was the first response assessment 56 days from the last dose according to the International Workshop on Chronic Lymphocytic Leukaemia (IWCLL) guidelines. Complete Response (CR) required: Peripheral blood lymphocytes below 4 x 10^9/L, Absence of significant lymphadenopathy, No hepatomegaly, No splenomegaly, Absence of disease, Blood counts above the following values (Neutrophils >1.5 x 10^9/L, Platelets >100 x 10^9/L, Hemoglobin >11g/dL) and Bone marrow at least normocellular for age. CRi was CR with incomplete bone marrow recovery. Partial Response (PR) required the following for at least 2 months from end of treatment: ≥50% decrease in peripheral blood lymphocyte count from the pre-treatment value AND Either a ≥ 50% reduction in lymphadenopathy OR ≥50% reduction of liver enlargement OR ≥50% reduction of spleen enlargement PLUS at least one of the following: Neutrophils >1.5 x 10^9/ or ≥50% increase, Platelets >100 x 10^9/L or ≥50% increase, Hemoglobin 11 g/dL or ≥50% increase.|Randomization to clinical cutoff (median observation 39 months)|Participants from the ITT population, all randomized participants, with data available for analysis. Participants who had not reached the 3-month follow-up visit at the time of the clinical cut-off were excluded from analysis.||percentage of participants||95% Confidence Interval|Number
650492|NCT02053610|Secondary|Percentage of Participants With Progression Free Survival Events Based on Independent Review Committee (IRC) Data|Percentage of Participants with Progression Free Survival Events: progression, relapse, or death from any cause as assessed by an Independent Review Committee.|Randomization to clinical cutoff (median observation 14.2 months)|ITT participants included all randomized participants.||percentage of participants|||Number
650493|NCT02053610|Secondary|Progression Free Survival Based on Independent Review Committee (IRC) Data|PFS was defined as the time from randomization to the first occurrence of progression, relapse, or death from any cause as assessed by Independent Review Committee. Progressive disease required at least one of the following: ≥50% increase in the absolute number of lymphocytes, appearance of new palpable lymph nodes (>15 mm in longest diameter) or any new extra nodal lesion, ≥50% increase in the longest diameter of any previous site of clinically significant lymphadenopathy, ≥50% increase in the enlargement of the liver and/or spleen, Transformation to a more aggressive histology or After treatment, the progression of any cytopenia (a decrease of hemoglobin levels >20 g/L or <10 g/dL or a decrease of platelet counts >50% or <100 x 10^9/L or by a decrease of neutrophil counts >50% or <1.0 x 10^9/L).|Randomization to clinical cutoff (median observation 18.8 months GClb and 18.6 months RClb)|Intent-to-treat population (ITT) included all randomized participants. Data for patients without disease progression or death was censored at the time of the last response assessment, or, if no response assessments were performed after the baseline visit, at the time of randomization plus one day.||months||95% Confidence Interval|Median
650494|NCT02053610|Primary|Percentage of Participants With Progression Free Survival Events|Percentage of Participants with Progression Free Survival Events: progression, relapse, or death.|Randomization to clinical cutoff (median observation 39 months)|ITT population included all randomized participants.||percentage of participants|||Number
650495|NCT02053610|Primary|Progression-free Survival (PFS)|PFS was defined as the time from randomization to the first occurrence of progression, relapse, or death from any cause as assessed by the investigator. Progressive disease required at least one of the following: ≥50% increase in the absolute number of lymphocytes, appearance of new palpable lymph nodes (>15 mm in longest diameter) or any new extra nodal lesion, ≥50% increase in the longest diameter of any previous site of clinically significant lymphadenopathy, ≥50% increase in the enlargement of the liver and/or spleen, Transformation to a more aggressive histology or After treatment, the progression of any cytopenia (a decrease of hemoglobin levels >20 g/L or <10 g/dL or a decrease of platelet counts >50% or <100 x 10^9/L or by a decrease of neutrophil counts >50% or <1.0 x 10^9/L).|Randomization to clinical cutoff (median observation 39 months)|Intent--to-treat population (ITT) included all randomized participants. Data for patients without disease progression or death was censored at the time of the last response assessment, or, if no response assessments were performed after the baseline visit, at the time of randomization plus one day.||months||95% Confidence Interval|Median
650496|NCT02053493|Secondary|Improvement in Daily Activity - Area Under the Curve (Phase II)|To evaluate whether isosorbide mononitrate in comparison to placebo improves daily activity as measured by Area under the curve (AUC) of arbitrary accelerometry units during study drug administration. An arbitrary accelerometer unit is calculated within the accelerometer device that is worn by the patient and represents level of activity based on patient movement. Higher values indicate more movement. 0 indicates no movement. Area under the curve is defined as ((7*average acceleromtery units/day during 30 mg) + (7*average acceleromtery units/day during 60 mg) + (14*average acceleromtery units/day during 120 mg))/28|9-12 weeks|Participants with usable data included in the results||accelerometry units||Standard Deviation|Mean
650497|NCT02053493|Secondary|Improvement in Daily Activity - Area Under the Curve (Phase I)|To evaluate whether isosorbide mononitrate in comparison to placebo improves daily activity as measured by Area under the curve (AUC) of arbitrary accelerometry units during study drug administration. An arbitrary accelerometer unit is calculated within the accelerometer device that is worn by the patient and represents level of activity based on patient movement. Higher values indicate more movement. 0 indicates no movement. Area under the curve is defined as ((7*average acceleromtery units/day during 30 mg) + (7*average acceleromtery units/day during 60 mg) + (14*average acceleromtery units/day during 120 mg))/28|3-6 weeks|Participants with usable data included in the results||accelerometry units||Standard Deviation|Mean
650498|NCT02053493|Secondary|Improvement in Daily Activity - Slope of Daily Average (Phase II)|To evaluate whether isosorbide mononitrate in comparison to placebo improves daily activity as measured by Slope of daily averaged arbitrary accelerometry units during study drug administration. An arbitrary accelerometer unit is calculated within the accelerometer device that is worn by the patient and represents level of activity based on patient movement. Higher values indicate more movement. 0 indicates no movement.|9-12 weeks|Participants with usable data included in the results||accelerometry units/day||Standard Deviation|Mean
650499|NCT02053493|Secondary|Improvement in Daily Activity - Slope of Daily Average (Phase I)|To evaluate whether isosorbide mononitrate in comparison to placebo improves daily activity as measured by Slope of daily averaged arbitrary accelerometry units during study drug administration. An arbitrary accelerometer unit is calculated within the accelerometer device that is worn by the patient and represents level of activity based on patient movement. Higher values indicate more movement. 0 indicates no movement.|3-6 weeks|Participants with usable data included in the results||accelerometry units/day||Standard Deviation|Mean
650504|NCT02053493|Primary|Arbitrary Accelerometry Units (AAU) (Phase II)|To evaluate whether isosorbide mononitrate increases daily activity as assessed by 14-day averaged arbitrary accelerometry units in comparison to placebo. An arbitrary accelerometer unit is calculated within the accelerometer device that is worn by the patient and represents level of activity based on patient movement. Higher values indicate more movement. 0 indicates no movement.|11-12 weeks|Participants with usable data included in the results||accelerometry units||Standard Deviation|Mean
650505|NCT02053493|Secondary|Kansas City Cardiomyopathy Questionnaire Overall Summary Score (Phase II)|To evaluate whether isosorbide mononitrate improves quality of life in comparison to placebo. • The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a disease-specific patient-reported outcomes measure for patients with heart failure. It consists of 23 items, is comprised of 7 clinically relevant scales (Symptom Frequency, Symptom Burden, Symptom Stability, Physical Limitation, Social Limitation, Quality of Life, and Self-Efficacy), and yields 3 summary scores (Clinical Summary, Total Symptom, and Overall Summary Scores). Scale and summary scores range between 0 and 100, with higher scores indicating better health status (eg, better functioning, fewer symptoms, better quality of life).Higher values of the overall KCCQ score are considered to be better than lower values.|Week 13|Participants with usable data included in the results||units on a scale||Standard Deviation|Mean
650506|NCT02053493|Secondary|Kansas City Cardiomyopathy Questionnaire Overall Summary Score (Phase I)|To evaluate whether isosorbide mononitrate improves quality of life in comparison to placebo. The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a disease-specific patient-reported outcomes measure for patients with heart failure. It consists of 23 items, is comprised of 7 clinically relevant scales (Symptom Frequency, Symptom Burden, Symptom Stability, Physical Limitation, Social Limitation, Quality of Life, and Self-Efficacy), and yields 3 summary scores (Clinical Summary, Total Symptom, and Overall Summary Scores). Scale and summary scores range between 0 and 100, with higher scores indicating better health status (eg, better functioning, fewer symptoms, better quality of life).|Week 7|Participants with usable data included in the results||units on a scale||Standard Deviation|Mean
650507|NCT02053493|Secondary|Borg Score During 6 Minute Walk Test (Phase II)|To evaluate whether isosorbide mononitrate improves quality of life in comparison to placebo. The Borg Scale consists of scale range of 0 to 10 (where 0 indicates no breathlessness at all and 10 indicates maximum breathlessness). Lower values are considered to be better than higher values.|Week 13|Participants with usable data included in the results||units on a scale||Standard Deviation|Mean
650508|NCT02053493|Secondary|Borg Score During 6 Minute Walk Test (Phase I)|To evaluate whether isosorbide mononitrate improves quality of life in comparison to placebo. The Borg Scale consists of scale range of 0 to 10 (where 0 indicates no breathlessness at all and 10 indicates maximum breathlessness). Lower values are considered to be better than higher values.|Week 7|Participants with usable data included in the results||units on a scale||Standard Deviation|Mean
650509|NCT02053493|Secondary|Patient Preference for Isosorbide Mononitrate Treatment at the End of Study.|Self reported participant preference for study period 1 vs. study period 2.|Week 13|Participants with usable data included in the results||participants|||Number
650510|NCT02053493|Secondary|Six Minute Walk Distance (Phase II)|To evaluate whether isosorbide mononitrate (ISMN) improves functional capacity by 6 minute walk distance in comparison to placebo.|Week 13|Participants with usable data included in the results||meters||Standard Deviation|Mean
650511|NCT02053493|Secondary|Six Minute Walk Distance (Phase I)|To evaluate whether isosorbide mononitrate (ISMN) improves functional capacity by 6 minute walk distance in comparison to placebo.|Week 7|Participants with usable data included in the results||meters||Standard Deviation|Mean
650512|NCT02053493|Primary|Arbitrary Accelerometry Units (AAU) (Phase I)|To evaluate whether isosorbide mononitrate increases daily activity as assessed by 14-day averaged arbitrary accelerometry units in comparison to placebo. An arbitrary accelerometer unit is calculated within the accelerometer device that is worn by the patient and represents level of activity based on patient movement. Higher values indicate more movement. 0 indicates no movement.|5-6 weeks|Participants with usable data included in the results||accelerometry units||Standard Deviation|Mean
650513|NCT02052895|Primary|Area Under the Receiver Operating Characteristic Curve (ROC-AUC) of the Plasma Presepsin Concentration for Discriminating Between SIRS and Sepsis|For the analysis, plasma presepsin levels on Day 0 were used and Sepsis/SIRS adjudication was made on Day 7 or day of discharge. ROC-AUC of presepsin for discriminating between SIRS and sepsis is compared to that of procalcitonin.|Up to 7 days|Out of 196 Sepsis/SIRS patients, 6 were excluded due to inclusion/exclusion criteria violation and 4 were excluded due to insufficient data for Sepsis/SIRS adjudication||probability||95% Confidence Interval|Least Squares Mean
650514|NCT02052752|Secondary|To Assess the Change in Perceptions of the Overall Appearance of Their Skin for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel|The participants were asked to rate the overall appearance of their facial skin as; 1= Very Dissatisfied; 2= Slightly Dissatisfied; 3= Neither Satisfied nor Dissatisfied; 4= Slightly Satisfied; 5= Very Satisfied. The responses were then tabulated.|Baseline to 2 hours, 4 hours, Day 1, Day 2, and Day 4|The analysis population consists of the ITT population. The ITT analysis set comprised of all participants who were randomized and received at least 1 application of study product and had baseline assessment.||Units on a scale||Standard Deviation|Mean
650515|NCT02052752|Secondary|To Assess the Change in Facial Skin Clarity for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel|The Skin clarity was measured using the following scale; 0 Very Clear; 1 Clear; 2 Dull; 3 Very Dull; 4 Unclear. The responses were then tabulated|Baseline to 2 hours, 4 hours, Day 1, Day 2, and Day 4|The analysis population consists of the ITT population. The ITT analysis set comprised of all participants who were randomized and received at least 1 application of study product and had baseline assessment.||Units on a scale||Standard Deviation|Mean
650516|NCT02052752|Secondary|To Assess the Percentage Change in Acne Lesion Diameter (Size) for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel.|The Investigator assessed and score each target lesion’s diameter (size). Diameter scores were the actual dimensions, i.e. the value in millimeters at the lesion’s widest or highest points.|Baseline to 2 hours, 4 hours, Day 1, Day 2, and Day 4|The analysis population consists of the ITT population. The ITT analysis set comprised of all participants who were randomized and received at least 1 application of study product and had baseline assessment.||Percentage change||Standard Deviation|Mean
650517|NCT02052752|Secondary|To Assess the Change in Acne Lesion Redness (Erythema) for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel.|The investigator assessed the erythema of the target lesion according to the following scale and tabulated the responses: 0=none, 1=minimal, 2=mild, 3=-moderate, 4=severe.|Baseline to 2 hours, 4 hours, Day 1, Day 2, and Day 4|The analysis population consists of the ITT population. The ITT analysis set comprised of all participants who were randomized and received at least 1 application of study product and had baseline assessment.||Units on a scale||Standard Deviation|Mean
650518|NCT02052752|Secondary|To Assess the Percentage Change in Acne Lesion Swelling (Height) for the 3% Benzoyl Peroxide Gel Test Product and Positive Control Relative to the Vehicle Gel.|The Investigator assessed and score each target lesion’s swelling (elevation), elevation scores were the actual dimensions, i.e. the value in millimeters at the lesion’s highest points. Percent change in height of all three target lesions were calculated and averaged for each participant. The average lesion height at baseline was calculated for each participant|Baseline to 2 hours, 4 hours, Day 1, Day 2 and Day 4|The analysis population consists of the ITT population. The ITT analysis set comprised of all participants who were randomized and received at least 1 application of study product and had baseline assessment.||Percentage change||Standard Deviation|Mean
650519|NCT02052752|Primary|To Assess the Percentage Change in Acne Lesion Swelling (Height) of the Target Lesion for 3% Benzoyl Peroxide (BPO) Gel Test Product Relative to the Vehicle Gel After 4 Once-daily Applications.|The Investigator assessed and score each target lesion’s swelling (elevation), elevation scores were the actual dimensions, i.e. the value in millimeters at the lesion’s highest points. Percent change in height of all three target lesions were calculated and averaged for each participant. The average lesion height at baseline was calculated for each participant. An analysis of covariance (ANCOVA) was performed with average percentage change in target lesion height as the response variable, treatment group (3% BPO or vehicle) as a main effect, and average baseline target lesion height as a covariate. A greater reduction in the percentage change in height of the target lesions indicated a better outcome measure|Baseline to Day 4|The analysis population consists of the intent-to-treat (ITT) population. The ITT analysis set comprised of all participants who were randomized and received at least 1 application of study product and had baseline assessment.||Percentage change||Standard Error|Mean
650520|NCT02052661|Secondary|Number of Subjects With Serious Adverse Events (SAEs).|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Month 0 to Month 1|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.||Subject|||Number
650521|NCT02052661|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs).|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Day 0–30) follow-up period after the single challenge dose of Engerix™-B Kinder vaccine.|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.||Subject|||Number
650522|NCT02052661|Secondary|Number of Subjects With Any Solicited General Symptoms.|Assessed solicited general symptoms were fatigue, gastrointestinal, headache and temperature [defined as axillary temperature equal to oe above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade.|During the 4-day (Day 0–3) follow-up period after the single challenge dose of Engerix™-B Kinder vaccine.|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.||Subject|||Number
650523|NCT02052661|Secondary|Number of Subjects With Any Solicited Local Symptoms.|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.|During the 4-day (Day 0–3) follow-up period after the single challenge dose of Engerix™-B Kinder vaccine.|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.||Subject|||Number
650524|NCT02052661|Secondary|Number of Subjects With an Anamnestic Response to the Single Challenge Dose of Engerix™-B Kinder Vaccine.|The amnestic response to the challenge dose was defined as: for initially seronegative subjects, antibody concentration ≥ 10mIU/mL; for initially seropositive subjects, antibody concentration at least four times the pre-challenge antibody concentration.|One month after the single challenge dose of Engerix™-B Kinder vaccine.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.||Subject|||Number
650525|NCT02052661|Secondary|Number of Subjects With Anti-HBs Antibody Concentrations ≥ 6.2 mIU/ml and ≥ 10 mIU/ml.|A seropositive subject was defined as a subject with anti-HBs antibody concentrations ≥ 6.2 mIU/ml. A seroprotected subjects was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/ml.|1 month after the single challenge dose of Engerix™-B Kinder vaccine.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.||Subject|||Number
650526|NCT02052661|Secondary|Number of Subjects With Anti-HBs Antibody Concentrations ≥ 6.2 mIU/ml, ≥ 10 mIU/ml, 10 to < 100 mIU/ml and ≥ 100 mIU/ml.|A seropositive subject was defined as a subject with anti-HBs antibody concentrations ≥ 6.2 milli-international units per milliliter (mIU/ml). A seroprotected subjects was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/ml.|Before the single challenge dose of Engerix™-B Kinder vaccine.|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects, aged 12-13 years at the time of enrolment, who did not received any additional dose of hepatitis B vaccine other than four doses of Infanrix™ hexa during first two years of life, for whom the serological results were available.||Subject|||Number
655250|NCT01953328|Secondary|Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
650527|NCT02052661|Secondary|Anti-HBs Antibody Concentrations at 12-13 Years of Age, After Previous Vaccination With Infanrix™ Hexa.|Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off of 6.2 mIU/ml.|Before (PRE) and 1 month after (POST) the single challenge dose of Engerix™-B Kinder vaccine.|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects, aged 12-13 years at the time of enrolment, who did not received any additional dose of hepatitis B vaccine other than four doses of Infanrix™ hexa during first two years of life, for whom the serological results were available.||mIU/mL||95% Confidence Interval|Geometric Mean
650528|NCT02052661|Primary|Anti-HBs Immune Response|Anti-HBs immune response was defined as the number of subjects with Anti-HBs antibody concentrations ≥ 100 mIU/ml.|One month after the single challenge dose of Engerix™-B Kinder vaccine (Month 1)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.||Subject|||Number
650529|NCT02052635|Primary|P2Y12 Reaction Units (PRU) Using VerifyNow™ at 1 Hour After Loading Dose|PRU at 1 hour after a single oral loading dose of either ticagrelor 180 mg or clopidogrel 600 mg given at the time of the bivalirudin bolus|1 hour post loading dose|10 patients were included in the PD analysis: 6 patients in the ticagrelor group and 4 patients in the clopidogrel group. Out of the 10 patients in the PD analysis, 1 patient in Ticagrelor group does not have PRU value at 1 hour post loading dose.||PRUs||Standard Deviation|Mean
650530|NCT02052635|Primary|P2Y12 Reaction Units (PRU) Using VerifyNow™ at 0.5 Hours After Loading Dose|PRU at 0.5 hours after a single oral loading dose of either ticagrelor 180 mg or clopidogrel 600 mg given at the time of the bivalirudin bolus|0.5 hours post loading dose|10 patients were included in the pharmacodynamic (PD) analysis: 6 patients in the ticagrelor group and 4 patients in the clopidogrel group. 3 out 13 randomized pateints are excluded (1 patient without any PRU data, 2 pateints with protocol deviations)||PRUs||Standard Deviation|Mean
650531|NCT02052544|Primary|Overall Sensitivity and Specificity of Pefakit and Hemosil.|Sensitivity is the proportion of positive cases identified as positive. Specificity is the proportion of negative cases identified as negative. The Sensitivity and Specificity of Pefakit and Hemosil were calculated for the overall study population and separately for each of the three medical centers. Sensitivity and Specificity of Pefakit and Hemosil were each assessed relative to the reference method (Biophen)|within 2 - 4 days|AVS (all valid subjects) population: All valid subjects with no major deviation affecting outcome.413 samples total analyzed||percentage of cases||95% Confidence Interval|Number
650532|NCT02052466|Secondary|Passive Shoulder Range of Motion - External Rotation|External rotation|At least 24 months after reverse TSA|||Degrees||Standard Deviation|Mean
650533|NCT02052466|Secondary|Passive Shoulder Range of Motion - Abduction|Abduction|At least 24 months after reverse TSA|||Degrees||Standard Deviation|Mean
650534|NCT02052466|Secondary|Passive Shoulder Range of Motion - Flexion|Flexion|At least 24 months after reverse TSA|||Degrees||Standard Deviation|Mean
650535|NCT02052466|Secondary|Active Shoulder Range of Motion - External Rotation|External rotation|At least 24 months after reverse TSA|||Degrees||Standard Deviation|Mean
650536|NCT02052466|Secondary|Active Shoulder Range of Motion - Abduction|Abduction|At least 24 months after reverse TSA|||Degrees||Standard Deviation|Mean
650537|NCT02052466|Secondary|Active Shoulder Range of Motion - Flexion|Flexion|At least 24 months after reverse TSA|||Degrees||Standard Deviation|Mean
650538|NCT02052466|Secondary|Shoulder Strength - External Rotation|Muscle strength test will be performed three times with each motion and recorded, using the Lafayette Manual Muscle Test System (Model # 01163). Units of output are pounds.|At least 24 months after TSA|||pounds||Standard Deviation|Mean
650539|NCT02052466|Secondary|Shoulder Strength - Internal Rotation|Muscle strength test will be performed three times with each motion and recorded, using the Lafayette Manual Muscle Test System (Model # 01163). Units of output are pounds.|At least 24 months after TSA|||pounds||Standard Deviation|Mean
650540|NCT02052466|Secondary|Shoulder Strength - Abduction|Muscle strength test will be performed three times with each motion and recorded, using the Lafayette Manual Muscle Test System (Model # 01163). Units of output are pounds.|At least 24 months after TSA|||pounds||Standard Deviation|Mean
650541|NCT02052466|Secondary|Shoulder Strength - Flexion|Muscle strength test will be performed three times with each motion and recorded, using the Lafayette Manual Muscle Test System (Model # 01163). Units of output are pounds.|At least 24 months after TSA|||pounds||Standard Deviation|Mean
650542|NCT02052466|Secondary|Patient Reported Pain, Satisfaction and Function (Penn Shoulder Score)|"The Penn Shoulder Score is a shoulder-specific patient reported outcome measure. Best possible score is 100; worst possible score is 0. There are 3 sub-scores: pain (3 questions, 30 possible points), satisfaction (1 question, 10 possible points), and function (20 questions, 60 possible points). Total score is the sum of the 3 sub-scores. For all sub-scores, higher is better.
The pain questions are based on a 10-point numeric rating scale. Points are added for the pain sub-score.
The satisfaction question asks the patient to rate their satisfaction with their shoulder. It is based on a 10-point numeric rating scale, with 0 as not satisfied and 10 as very satisfied.
The function sub-score has 20 questions concerning activities of daily living. The response options are: 0 (can't do at all), 1 (can do with much difficulty), 2 (can do with some difficulty) and 3 (can do with no difficulty). If all activities can be done without difficulty, a score of 60 is achieved."|At least 24 months after reverse TSA|||Scores on the Penn Shoulder Score scale||Standard Deviation|Mean
650543|NCT02052466|Primary|Actual Versus Predicted Scapular Notching|At minimum 2 year follow-up, compare presence of scapular notching as assessed by 2D x-ray and 3D CT imaging with predicted scapular notching as assessed by 3D computer modeling using video motion analysis of subject range of motion.|At least 24 months after reverse TSA|Patients who had video motion analysis of their range of motion at minimum 2 year follow-up||percentage of accurate predictions|||Number
650544|NCT02052414|Other Pre-specified|Patient Global Impression of Change (PGIC)|Patient Global impression of Change (PGIC) is an outcome commonly used measure of the efficacy of treatments. PGIC is a 7 point scale that requires the subjects to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.|15 Weeks.|||units on a scale||Standard Deviation|Mean
650545|NCT02052414|Secondary|Fibromyalgia Impact Questionnaire (FIQ)|The Fibromyalgia Impact Questionnaire (FIQ) is an instrument designed to quantitate the overall impact of fibromyalgia over many dimensions (e.g. function, pain level, fatigue, sleep disturbance, psychological distress etc.). It is scored from 0 to 100 with the latter number being the worst case. The average score for patients seen in tertiary care settings is about 50. The FIQ is widely used to assess change in fibromyalgia status.|15 weeks.|FM patients who took study medication.||units on a scale||Standard Deviation|Mean
650546|NCT02052414|Secondary|Self Reported Side Effects.|Side / adverse effects were assessed at each follow up visits and resulted are as follows.|15 Weeks|Subject who experienced pain, acute delirium, symptoms related to adhesions due to prior surgical procedures, extremity swelling, and possible drug interactions discontinued medications. Other reported side effects dissipated after subjects reached therapeutic dose of 1800mg of study medication taken at bedtime.||participants|||Number
650547|NCT02052414|Secondary|Medical Outcome Study (MOS) Sleep Questionnaires|"Medical Outcomes Study (MOS) sleep questionnaires to assess how Fibromyalgia impacts patients' sleep in various areas.
Specifically, Data reported below measured number of hours subjects spent per night sleeping. MOS sleep questionnaires were assessed at each follow up visits. (visits 1, 2, 3, 4, and 5)."|15 weeks|||Hours||Standard Error|Mean
650548|NCT02052414|Primary|Numeric Pain Rating System (NPRS)|Fibromyalgia pain experienced by study subjects will be captured using NPRS at baseline visit, at each follow visits that are scheduled to occur every 4 weeks over 12 weeks of treatment period, and at the end of treatment visit that will occur 3 weeks after treatment period (12 weeks treatment period + 3 weeks = 15 weeks). Any difference in NPRS scores between baseline and any subsequent visits will indicate the magnitude of pain relief as reflected in digital scale of 0-10 (0=no pain, 10=worst pain imaginable).|15 weeks|All subjects had diagnosis of fibromyalgia and met the inclusion and exclusion criteria.||units on a scale||Standard Deviation|Mean
650549|NCT02052011|Primary|Coronary Flow Reserve|Compare changes in coronary flow reserve as measured by cardiac PET(Positron Emission Tomography) in patients receiving Ranolazine versus control. This is the ratio between stress and rest myocardial blood flow in response to stress.|4 weeks|||ratio||Standard Deviation|Mean
650550|NCT02051816|Secondary|Grade View of the Glottis|Best Cormack-Lehane grade view of the glottis (grade 1-4) on first laryngoscopy attempt. Higher grades on the 1-4 scale indicate worse glottic views.|1 hour|||units on a scale||Standard Deviation|Mean
650551|NCT02051816|Secondary|Number of Esophageal Intubations Per Group|Number of esophageal intubations Per Study Group|1 hour|||number of esophageal intubations|||Number
650552|NCT02051816|Secondary|Ventilator-free Days|Number of days alive and free of mechanical ventilation after endotracheal intubation|28 days|||DAYS||Standard Deviation|Mean
650553|NCT02051816|Secondary|Adjusted Lowest Arterial Oxygen Saturation During Procedure|Arterial oxygen saturation nadir (defined as lowest noninvasive oxygenation saturation value observed between the administration of sedation and/or neuromuscular blockade and 2 minutes after successfully secured airway or death) adjusted for arterial oxygen saturation at the time of administering intubation drugs.|1 hour|||PERCENT SATURATION||Standard Deviation|Mean
650554|NCT02051816|Secondary|ICU-mortality|Death from any cause in the ICU and at anytime after the procedure|28 days|||Participants|||Count of Participants
650555|NCT02051816|Secondary|Procedure-related Mortality|Death within 1 hour of beginning the procedure|1 hour|||Participants|||Count of Participants
650556|NCT02051816|Primary|Arterial Oxygen Saturation Nadir (Defined as Lowest Noninvasive Oxygenation Saturation Value Observed Between the Administration of Sedation and/or Neuromuscular Blockade and 2 Minutes After Successfully Secured Airway or Death).|The primary outcome for the apneic oxygenation arm of the study is arterial oxygen saturation nadir (defined as lowest noninvasive oxygenation saturation value observed between the administration of sedation and/or neuromuscular blockade and 2 minutes after successfully secured airway or death).|1 hour|||percent arterial oxygen saturation||Inter-Quartile Range|Median
650557|NCT02051816|Primary|Successful First Attempt at Endotracheal Intubation (Defined by Confirmed Placement of an Endotracheal Tube in the Trachea During First Laryngoscopy Attempt) After Controlling for the Operator’s Past Number of Procedures With the Equipment Used.|The primary outcome for the video laryngoscopy compared with direct laryngoscopy arm of the study will be the successful first attempt at endotracheal intubation (defined by confirmed placement of an endotracheal tube in the trachea during first laryngoscopy attempt) after controlling for the operator’s past number of procedures with the equipment used.|1 hour|||participants|||Number
650558|NCT02051790|Primary|Agreement Between Expert Panel and Clinical Practice Reads|Agreement between expert panel consensus scan interpretations and clinical practice reader scan interpretations was calculated as a weighted Kappa value across all cases and all clinical practice readers.|Scan acquired 50-60 minutes post injection|||Weighted Kappa statistic||95% Confidence Interval|Number
650559|NCT02051595|Primary|Circulating Vancomycin Concentration|Blood samples to monitor the vancomycin concentration will be collected at several time points during surgery.|Time points: pre CPB (t=1), post CPB at 5 (t=2), 30 (t=3), 60 (t=4), 108 (t=5), 240 (t=6) minutes, prior to ultrafiltration (t=7), end of ultrafiltration (t=8), ultrafiltrate (t=9) ,effluent of cell saver (t=10)|||µg/mL||Standard Deviation|Mean
650560|NCT02051426|Primary|Change in Rey Auditory Verbal Learning Test RAVLT (Trial 7) - From Baseline to 2 Hours|RAVLT measures short term verbal memory, verbal learning, susceptibility to (proactive and retroactive) interference, retention of information after a certain period of time during which other activities are performed and recognition memory. The test consists of a list of 15 common nouns, which are read to the subject in five consecutive trials (trials 1 through 5); each reading is followed by a free-recall task. In trial 6, an interface list of 15 new common nouns is presented, followed by free recall of these new nouns. In trial 7, without additional reading, subjects are again asked to recall the first list. Twenty minutes later, without an additional reading, subjects are asked to recall once more the first list (trial 8). The RAVLT score range from 0-90 correctly recalled words. For trial 7 the score ranges from 0 to 15 correctly recalled words.|Baseline, 2 hours post intervention|||units on a scale||Standard Deviation|Mean
650561|NCT02051426|Primary|Change in Cognitive Function- CPT-IP D-prime Score - From Baseline to 2 Hours|"The d-prime score is a score given to each participant on a scale of 0.0 - 1.0 in which discrimination sensitivity is measured. A score of 0 equates to no sensitivity whereas a score of 1.0 equates to perfect sensitivity."|Baseline, 2 hours post intervention|||units on a scale||Standard Deviation|Mean
650563|NCT02051335|Secondary|Percentage of Participants With Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters at Least Once Post-Dose|The percentage of participants who meet markedly abnormal criteria specified by the protocol and statistical analysis plan=abnormal clinically significant.|Day 1 up to Day 95|Safety Analysis Set included all enrolled participants who received at least one dose of study drug.||percentage of participants|||Number
650564|NCT02051335|Secondary|Percentage of Participants With Markedly Abnormal Vital Sign Measurements at Least Once Post-dose|The percentage of participants who meet markedly abnormal criteria for vital signs, including oral body temperature, respiration rate, pulse, and resting blood pressure and after standing.|Day 1 up to Day 95|Safety Analysis Set included all enrolled participants who received at least one dose of study drug.||percentage of participants|||Number
650565|NCT02051335|Secondary|Percentage of Participants With Markedly Abnormal Safety Laboratory Tests|The percentage of participants with any markedly abnormal standard safety laboratory values, including hematology, serum chemistries, and urinalysis. LLN=lower limit of normal. ULN=upper limit of normal.|Day 1 up to Day 95|Safety Analysis Set included all enrolled participants who received at least one dose of study drug.||percentage of participants|||Number
650566|NCT02051335|Secondary|Percentage of Participants Who Experience at Least 1 Treatment Emergent Adverse Event (TEAE)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as any adverse event, regardless of relationship to study drug that occurs or worsens after the first dose of study drug and no more than 14 days after the last dose of study drug.|Day 1 up to Day 95|Safety Analysis Set included all enrolled participants who received at least one dose of study drug.||percentage of participants|||Number
650567|NCT02051335|Secondary|Change From Baseline in the Spatial Working Memory (SWM) Total Number of Between Errors at the 10-Box Stage and the 12-Box Stage at All Time-points Assessed After Scopolamine Administration|SWM assesses the ability to retain spatial information and manipulate it in working memory. In this task, colored boxes are shown on the screen, and participants must search for blue tokens by touching the colored boxes to open them. When the blue token has been found the participant has to place the token in the black column (‘home’) on the right-hand side of the screen by touching this area. The participant must not return to a box where a token has previously been found. The task becomes more difficult as the number of boxes increases (one trial at each of 6-box and 8-box stages; three trials at each of 10-box and 12-box stages). Between Errors is the total number of times the participant revisits a box in which a token has previously been found in the same problem. The possible range of errors is 0 (best) to 1040 (worst). Lower number of errors in the test indicates a better outcome.|Baseline and at 1, 2 and 4 hours after scopolamine administration on Day 1 of each treatment period.|Participants from the Full Analysis Set with data available for analysis at the given time-point.||errors||Standard Deviation|Mean
650568|NCT02051335|Secondary|Change From Baseline in the Rapid Visual Information Processing (RVP) Median Latency at All Time-points Assessed After Scopolamine Administration|RVP is a task of continuous performance and visual sustained attention. The task consists of a 2-minute practice stage and a 7-minute assessed stage. There is a white box in the centre of the screen in which single digits from 2 to 9 appear one at a time in a pseudo-random order at a rate of 100 digits per minute. Participants must detect target sequences of digits (2-4-6, 3-5-7, and 4-6-8) and touch a button when they see the last digit of a target sequence. Nine target sequences appear every 100 numbers. Assessment will be based on a median latency. The possible range for RVP median latency is 100 (worst) to 1900 (best). Higher number in the test indicates a better outcome. “Median latency” is a measure captured by computerized test measure and given as “one” time value (between 100 and 1900). The “mean” of these values is presented.|Baseline and at 1, 2 and 4 hours after scopolamine administration on Day 1 of each treatment period.|Participants from the Full Analysis Set with data available for analysis at the given time-point.||msec||Standard Deviation|Mean
650569|NCT02051335|Secondary|Change From Baseline in the Rapid Visual Information Processing (RVP) A Prime Signal Detection at All Time-points Assessed After Scopolamine Administration|RVP is a task of continuous performance and visual sustained attention. The task consists of a 2-minute practice stage and a 7-minute assessed stage. There is a white box in the centre of the screen in which single digits from 2 to 9 appear one at a time in a pseudo-random order at a rate of 100 digits per minute. Participants must detect target sequences of digits (2-4-6, 3-5-7, and 4-6-8) and touch a button when they see the last digit of a target sequence. Nine target sequences appear every 100 numbers. A prime (A′) is a signal detection measure that reflects target sensitivity regardless of the participant’s tendency, or bias, to respond. Detection sensitivity for RVP A’ prime: 0 to 1. Lower numbers in the test indicates worsening in the performance.|Baseline and at 1, 2 and 4 hours after scopolamine administration on Day 1 of each treatment period.|Participants from the Full Analysis Set with data available for analysis at the given time-point.||unitless||Standard Deviation|Mean
650570|NCT02051335|Secondary|Change From Baseline in the Paired Associates Learning (PAL) Total Number of Errors Adjusted at All Time-points Assessed After Scopolamine Administration|PAL assesses visuospatial associative learning and memory. Boxes are displayed on the screen and open in a randomised order to reveal a number of patterns. The patterns are then displayed in the middle of the screen, one at a time, and the participant must touch the box where the pattern was originally located. If the participant makes an error, the patterns are re-presented to remind the participant of their locations. If the participant has not responded correctly within six attempts, ie, one presentation and five re-presentations, the task is terminated. As the task progresses the difficulty level increases with the number of patterns to be remembered. For participants who fail to complete all levels, an adjusted total is calculated that takes into account errors predicted in the stages that were not attempted. The possible range for total errors is 0 (best) to 91 (worst). Fewer number of errors in the test indicates a better outcome.|Baseline and at 1, 2 and 4 hours after scopolamine administration on Day 1 of each treatment period.|Participants from the Full Analysis Set with data available for analysis at the given time-point.||errors||Standard Deviation|Mean
651342|NCT02030535|Secondary|Peak RR Change From Patient Baseline Over All Post-dose Time Points|Peak RR change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)||ms||Standard Deviation|Mean
650571|NCT02051335|Secondary|Change From Baseline in the Verbal Recall Memory (VRM) Total Number of Correct Responses for Immediate and Delayed Recall at 2 and 4 Hours After Scopolamine Administration|VRM measures the ability to encode and subsequently retrieve verbal information. This task begins with the first presentation phase in which 18 words are shown in turn on the screen. The participant is then asked to recall as many words as possible during the first immediate recall phase. The same 18 words are then shown in a second presentation phase which is followed by a second immediate recall phase. After a delay of approximately 20-30 minutes, a delayed recall stage is completed. The possible range of correct responses is 0 (worst) to 18 (best). Higher number of correct responses in the test indicates a better outcome. A negative change from baseline indicates a worsening of the score.|Baseline and 2 and 4 hours after scopolamine administration on Day 1 of each treatment period.|Participants from the Full Analysis Set with data available for analysis at the given time-point.||correct responses||Standard Deviation|Mean
650572|NCT02051335|Primary|Change From Baseline in the Verbal Recall Memory (VRM) Total Number of Correct Responses for Immediate Recall at 1 Hour After Scopolamine Administration|VRM measures the ability to encode and subsequently retrieve verbal information. This task begins with the first presentation phase in which 18 words are shown in turn on the screen. The participant is then asked to recall as many words as possible during the first immediate recall phase. The possible range of correct responses is 0 (worst) to 18 (best). Higher number of correct responses in the test indicates a better outcome. A negative change from baseline indicates a worsening of the score.|Baseline and 1 hour after scopolamine administration on Day 1 of each treatment period.|Participants from the Full Analysis Set with data available for analysis at the given time-point.||correct responses||Standard Deviation|Mean
650573|NCT02051335|Primary|Change From Baseline in the Verbal Recall Memory (VRM) Total Number of Correct Responses for Delayed Recall at 1 Hour After Scopolamine Administration|VRM measures the ability to encode and subsequently retrieve verbal information. This task begins with the first presentation phase in which 18 words are shown in turn on the screen. The participant is then asked to recall as many words as possible during the first immediate recall phase. The same 18 words are then shown in a second presentation phase which is followed by a second immediate recall phase. After a delay of approximately 20-30 minutes, a delayed recall stage is completed. The possible range of correct responses is 0 (worst) to 18 (best). Higher number of correct responses in the test indicates a better outcome. A negative change from baseline indicates a worsening of the score.|Baseline and 1 hour after scopolamine administration on Day 1 of each treatment period. Baseline is defined as the assessment 1 hour before roflumilast/donepezil administration (3 hours before scopolamine administration).|Participants from the Full Analysis Set with data available for analysis at the given time-point.||correct responses||Standard Deviation|Mean
650574|NCT02050334|Secondary|Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0.5, 1, 2, 3, 4, 5, 8, 12, 24 hrs post CC100|16 of 18 participants had data from drug level assays.The PK parameter analysis population included participants who received single CC100 dose(s) of 2, 5, 10, and/or 20 mg. Some PK parameters had fewer participants, if there were too few data points to analyze from a participant.||hours||Standard Error|Mean
650575|NCT02050334|Secondary|Pharmacokinetics (PK)|Time to Reach Maximum Observed Plasma Concentration (Tmax)|0.5, 1, 2, 3, 4, 5, 8, 12, 24 hrs post CC100|16 of 18 participants had data from drug level assays.The PK parameter analysis population included participants who received single CC100 dose(s) of 2, 5, 10, and/or 20 mg. Some PK parameters had fewer participants, if there were too few data points to analyze from a participant.||hours||Standard Error|Mean
650576|NCT02050334|Primary|Unsolicited Adverse Event Reports|Safety and Tolerability assessed by arm/group and dose received measured by number of unsolicited AEs within a minimum of 24 hours after each dose.|Minimum of 24 hours after each dose.|All 18 subjects analyzed, per protocol.||Unsolicited Adverse Event Reports|||Number
650577|NCT02050321|Secondary|Adverse Events|The study period during which all AEs must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier. All adverse events will be classified using either the MedDRA term or NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0|Basline through 30 Days post Treatment||||||
650578|NCT02050321|Primary|Rate of Development of cSCC at 6 Months (Biopsy Confirmed).||6 months post treatment||||||
650579|NCT02050048|Secondary|Number of Participants With Adverse Events Related to Fluid Overload|A portion of the study will assess whether there is a significant risk of adverse events related to fluid overload states in the high volume (HV) intervention arm. We anticipate the rate of adverse events in patients randomized to the HV arm to be small. By using more modest, weight based regimens, we aim to optimize benefit while eliminating overly aggressive fluid administration and causing undue harm.|Phase II portion (~1 year)||||||
650580|NCT02050048|Primary|Development of Post-ERCP Pancreatitis|Patients will be monitored after procedure to see if they develop abdominal pain. If so, serum amylase and lipase blood draws will be completed at least once every 24 hours following procedure to monitor the development of post-ERCP pancreatitis. If patients do not develop abdominal pain following the procedure, research staff will follow up with the patients 5 days and 29 days after the procedure to evaluate for the development of post-ERCP pancreatitis and other related or unrelated complications.|Assessed 90 minutes after procedure, 5 days after procedure, and 29 days after procedure|||participants|||Number
650581|NCT02049931|Secondary|the Progression of Body Compression Ratio Over All Follow-up Assessments||at the initial enrollment, 2 weeks, 6 weeks, and 12 weeks after compression fracture||||||
650582|NCT02049931|Secondary|General Health Status|The general health status was assessed with use of the Short Form-36 (SF-36) at the initial enrollment and 12 weeks after compression fracture.|at the initial enrollment and 12 weeks after compression fracture||||||
650583|NCT02049931|Secondary|Oswestry Disability Index (ODI)||at 2 weeks, 6 weeks, and 12 weeks after compression fracture.||||||
650584|NCT02049931|Secondary|Visual Analog Pain Scale (VAS) for Back Pain|The VAS for back pain comprised a 10-cm line with “none” (0) on one end and “disabled pain” (10) on the other. Participants were asked to place a mark on the 10-cm line, which represented his or her perceived level of back pain, and the measured distance (cm) from the mark to the zero point was considered the score.|2 weeks, 6 weeks, 12 weeks after injury||||||
655251|NCT01953328|Secondary|Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12||Week 12|Full analysis set||percentage of participants||95% Confidence Interval|Number
650585|NCT02049931|Primary|Oswestry Disability Index (ODI) at 12 Weeks|The primary outcome was the score for Oswestry Disability Index (ODI) at 12 weeks after compression fracture. The ODI is a self-reported questionnaire measuring back-specific function including pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling. The questionnaire consists of 10 items each with 6 response levels. Each item is scored from 0 to 5, and the total score is converted to a 0 to 100 scale (zero is equated with no disability and 100 is the maximum disability possible).|12 weeks after injury|||units on a scale||95% Confidence Interval|Mean
650586|NCT02049450|Secondary|Pharmacokinetics (PK) Parameter of Cmax|"Cmax (1h) of INC424 by actual dose administered from 10mg bid to 20mg bid. Plasma PK samples were collected at Day 1, Week 2, and Week 12. Cmax was collected within a +/- 1 hour post dose.
n= number of patients with valid PK samples as per definition of the PK analysis set."|Day 1, Week 2 (Day 15), Week 12 (Day 85)|The PK analysis set includes all patients with at least one evaluable PK sample at any visit.||ng/mL||Standard Deviation|Mean
650587|NCT02049450|Secondary|Pharmacokinetics (PK) Parameter of Cmin|C min of INC424 by actual dose administered from 10mg bid to 20mg bid. Plasma PK samples were collected at Day 15 (Week 2), and Day 85 (Week 12). Cmin was collected immediately prior to dosing. n= number of patients with valid PK samples as per definition of the PK analysis set.|week 2, week 12|The PK analysis set includes all patients with at least one evaluable PK sample at any visit.||ng/mL||Standard Deviation|Mean
650588|NCT02049450|Secondary|Percentage Change in Spleen Length (cm) Below the Left Coastal Margin|Change of spleen length from baseline over time measured by palpitation by time|baseline, weeks 1,2,3,4,6,12,18,24,30|The Safety Set consists of all patients who received at least one dose of ruxolitinib. All safety data was analyzed using the Safety set. The FAS and Safety set are identical in this study.||percentage change in spleen length||Standard Deviation|Mean
650589|NCT02049450|Secondary|Percentage Change in Mean Pre-transfusion Hemoglobin by 6 Week Time Intervals|Change from baseline in pre-transfusion hemoglobin levels|baseline, weeks 0 - 30|The Safety Set consists of all patients who received at least one dose of ruxolitinib. All safety data was analyzed using the Safety set. The FAS and Safety set are identical in this study.||percentage change of hemoglobin levels||Standard Deviation|Mean
650590|NCT02049450|Secondary|Percentage Change in Spleen Volume (cm3)|Change of spleen volume from baseline at week 12 and week 30 as measured by magnetic imaging resonance (MRI) or computed tomography (CT).|baseline, week 12, week 30|The Safety Set consisted of all patients who received at least one dose of ruxolitinib. All safety data was analyzed using the Safety set. The FAS and Safety set are identical in this study.||percentage change||Standard Deviation|Mean
650591|NCT02049450|Primary|Change of Hematocrit Adjusted Volume of Red Blood Cells (RBC)|Change of RBC transfusion requirement measured as percent change of the hematocrit-adjusted volume of transfused RBC and observed during within on-treatment interval (any time-points of RBC transfusion between week 6 and week 30 driven by the individual patient’s need) compared to baseline (defined by pre-treatment interval between Week – 24 to start of treatment).|week 6 to week 30 interval|Per-Protocol Set (PPS) consisted of a subset of patients in the Safety Set who were compliant with requirements of the Study Protocol. Patients were excluded from the PPS if: they had no or incomplete history of RBC transfusions within 24 weeks prior to the first dose of ruxolitinib or discontinued treatment with ruxolitinib prior to Week 18.||% change of hematocrit-adjusted volume||Standard Deviation|Mean
650592|NCT02049151|Secondary|Number Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, National Cancer Institute-Common Toxicity Criteria (NCI−CTC)Grade 3/4 TEAEs, TEAEs Leading to Permanent Discontinuation, TEAEs Leading to Death, Injection Site Reactions (ISRs)|An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. A serious TEAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs occurred between the first dose of study drug and up to 42 days after the last dose that were absent before treatment or that worsened relative to pretreatment state. Number of Subjects With TEAEs, Serious TEAEs, NCI−CTC Grade 3/4 TEAEs, TEAEs Leading to Permanent Discontinuation, TEAEs Leading to Death, and ISRs were reported.|Time from first dose up to 42 days after the last dose of the trial treatment: assessed maximum up to 16 months|Safety Analysis Set included all subjects who had taken at least one dose of trial treatment (tecemotide [L-BLP25] or placebo), including cyclophosphamide or saline.||subjects|||Number
650593|NCT02049151|Secondary|Time to Progression (TTP)|TTP was measured from the date of randomization to the date of tumor progression. Date of tumor progression was date of radiological diagnosis of PD, performed as per RECIST 1.1. PD is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1 or more new lesions is also considered progression. For participants alive without tumor progression at time of analysis, the time between date of randomization and date of last trial treatment was calculated and used as a censored observation in the analysis. Subjects dying from causes other than PD was censored at time of death.|Time from date of randomization until PD, assessed up to 16 months|Analysis was not performed due to the premature termination of this study and the tecemotide program based on negative results in EMR 63325-009 (NCT00960115).|||||
650594|NCT02049151|Secondary|Progression Free Survival (PFS)|PFS was defined as the time from date of randomization until date of the first documentation of PD or death due to any cause in the absence of documented PD, whichever occurred first. PFS was assessed as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). PD was defined as at least a 20% increase in the sum of longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. Subjects without event were censored on the date of last tumor assessment.|Time from date of randomization until PD or death, assessed up to 16 months|Analysis was not performed due to the premature termination of this study and the tecemotide program based on negative results in EMR 63325-009 (NCT00960115).|||||
650621|NCT02046772|Primary|Measurement of Time to Start the Anaesthetic Effect|To compare whether the addition of morphine chloride to a low dose intradural solution of the local anaesthetic bupivacaine is as effective as an administration of a single dose of bupivacaine.|First 20 minutes between administration and beginning of surgery|||minutes||Standard Deviation|Mean
650595|NCT02049151|Secondary|Time to Symptom Progression (TTSP)|TTSP was measured from date of randomization to date of disease progression (defined based on RECIST v1.1), using the lung cancer symptom scale (LCSS), a validated questionnaire consisting of an observer scale and a subject scale used to specifically measure symptom changes relevant to quality of life (QoL) for individuals undergoing treatment for lung cancer. Subject scale was used as a tool to determine TTSP. It was a 9-item questionnaire used to document subject-reported outcomes for a variety of lung cancer associated symptoms. The average symptomatic burden index (ASBI) was used to determine differences in the treatment groups. ASBI was the mean of the 6 symptom scores derived from the LCSS questionnaire. Symptom progression was defined as an increase (worsening) of the ASBI score of 10% of the scale breadth (10 mm on a scale of 0-100 mm) from the baseline score on at least 2 consecutive assessments during the period when assessments are performed every 3 weeks and every 6 weeks.|Time from date of randomization until progressive disease (PD), assessed up to 16 months|Analysis was not performed due to the premature termination of this study and the tecemotide program based on negative results in EMR 63325-009 (NCT00960115).|||||
650596|NCT02049151|Primary|Overall Survival|Overall survival (OS) was defined as the time (in months) from randomization to death. Data has been presented in terms of number subjects who died and number of censored subjects.|Time from date of randomization until death, assessed maximum up to 16 months|Safety Analysis Set included all subjects who had taken at least one dose of trial treatment (tecemotide [L-BLP25] or placebo), including cyclophosphamide or saline. Analysis was not performed due to the premature termination of this study and the tecemotide program based on negative results in EMR 63325-009 (NCT00960115).||subjects|||Number
650597|NCT02048904|Primary|Change in Microalbuminuria Level|Decrease in microalbuminuria level|Six months|Zero participants were analyzed due to early termination of study related to technical/operational difficulties at the study site.|||||
650598|NCT02048891|Secondary|Patients Comfort During the Luteal Phase||During 2 weeks from day of oocyte retrieval||||||
650599|NCT02048891|Primary|Fetal Heart Activity 1 Month After Oocyte Retrieval|Fetal heart activity as seen by vaginal ultrsound imaging 1 month after oocyte retrieval|1 month after oocyte retrieval|||participants with fetal heart activity|||Number
650600|NCT02048072|Primary|RMSSD Normal Breathing|"Root Mean Square of the Successive Differences (RMSSD) is one of a few time-domain tools used to assess heart rate variability, the successive differences being neighboring RR or pulse intervals.
It is calculated as the square root of the mean of the squares of the successive differences between adjacent RR intervals or pulse intervals.
In this study pulse intervals were measured non-invasively during five minutes, while subjects were supine, breathing regularly.
Measurements were done at two timepoints t=0 and t=4,5hours. RMSSD was compared between these two timepoints."|t-4,5 hours|||milliseconds||95% Confidence Interval|Mean
650601|NCT02047747|Secondary|Treatment-emergent Adverse Events||End of Treatment (4-6 weeks after permanent discontinuation of study treatment for any reason)|The study was terminated due to slow enrollment. Please see adverse event section for additional information.|||||
650602|NCT02047747|Primary|Intra-cranial Objective Response Rate|Intra-cranial objective response rate at 2 months as assessed by the Response Assessment in Neuro-oncology (RANO) criteria|2 months|Subjects did not complete the study as planned. Zero participants analyzed due to termination of study. Data not available.|||||
650603|NCT02047227|Secondary|Biochemical Pregnancy Rate|Biochemical pregnancy rate was defined as the percentage of subjects with a positive beta-hCG result from the serum pregnancy test.|15 to 20 days post r-hCG administration (Day 132)|MITT Analysis Set included all randomized subjects who received at least 1 dose of GONAL-f or Pergoveris and did not have spontaneous pregnancy or death at approximately 34-38 hours after rhCG administration.||percentage of subjects|||Number
650604|NCT02047227|Secondary|Clinical Pregnancy Rate|Clinical pregnancy rate defined as the percentage of subjects with a ultrasound confirmation of a gestational sac, with or without fetal heart activity.|35-42 days post r-hCG administration (Day 154)|MITT analysis set included all randomized subjects who received at least 1 dose of GONAL-f or Pergoveris and did not have spontaneous pregnancy or death at approximately 34-38 hours after rhCG administration.||percentage of subjects|||Number
650605|NCT02047227|Secondary|Embryo Implantation Rate|Embryo implantation rate was measured as the number of gestational sacs observed divided by the number of embryos transferred multiplied by 100.|35-42 days post r-hCG administration (Day 154)|"MITT analysis set included all randomized subjects who received at least 1 dose of GONAL-f or Pergoveris and did not have spontaneous pregnancy or death at approximately 34-38 hours after rhCG administration. Here Number of subjects analyzed signifies those subjects who were evaluable for this outcome measure."||percent sacs per embryo|||Number
650606|NCT02047227|Secondary|Live Birth Rate|Live birth rate was defined as the percentage of subjects with at least one live-born neonate.|Approximately 180 days following ongoing pregnancy determination (Day 365)|MITT analysis set included all randomized subjects who received at least 1 dose of GONAL-f or Pergoveris and did not have spontaneous pregnancy or death at approximately 34-38 hours after rhCG administration.||percentage of subjects|||Number
650607|NCT02047227|Secondary|Ongoing Pregnancy Rate|Ongoing pregnancy rate was defined as the percentage of subjects with a ultrasound confirmation of at least one viable fetus (positive fetal heart beat).|70 days after embryo transfer (Day 185)|Modified intent-to-treat (MITT) analysis set included all randomized subjects who received at least 1 dose of GONAL-f or Pergoveris and did not have spontaneous pregnancy or death at approximately 34-38 hours after rhCG administration.||percentage of subjects|||Number
650608|NCT02047227|Primary|Number of Oocytes Retrieved|Mean number of oocytes retrieved on the day of ovum pick up (OPU) was calculated. Oocyte retrieval was a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body.|At approximately 34 to 38 hours after r-hCG administration (Day 113)|Intent-to-treat (ITT) analysis set included all subjects randomized who received at least 1 dose of GONAL-f or Pergoveris.||oocytes||Standard Deviation|Mean
650622|NCT02046265|Primary|Human Papilloma Virus (HPV) Vaccine #1 Acceptance||For each participant, at end of first study visit. Will assess until all subjects enrolled in study.|All participants in the analysis were eligible to recieve the HPV vaccine.||Participants|||Count of Participants
650623|NCT02046226|Secondary|Incidence of Complete Wound Closure|number of wounds undergoing complete reepithelialization without drainage or dressing requirements, maintained for at least 2 weeks.|3 months|Study subjects were not available to provide data when the secondary outcome was to be reported, and thus there are no secondary outcome data to report.|||||
650609|NCT02046993|Primary|Comparison Between Mean Home Systolic and Diastolic Blood Pressure HSBP and HDBP Readings at 6 Months Between the Smartphone Based Telemonitoring Group and Control Group on Enhanced Usual Care|At baseline and follow-up visits, research assistants will collect the HSBP and HSBP readings of both groups at baseline, 3rd and 6th month FU. Regular home BP measurement is taken as the average of at least 3 or more BP measurement readings per week. The research assistant are not blinded and will collect the average of paper SBP and DBP measurement recordings ( if done) of the control group at baseline,at 3rd month and 6th month. The research assistant are not blinded and will collect the average of smartphone based SBP and DBP measurement recordings ( if done) and sent to the data center of the intervention group at baseline,at 3rd month and 6th month.|6 months|The mean average of the HSBP and HDBP of both groups who have taken and recorded their blood pressure readings at least 3x or more per week are collected||mmHg||Standard Deviation|Mean
650610|NCT02046993|Primary|Comparison of Mean Home Systolic and Diastolic Blood Pressure mHSBP and mHDBP Readings at 3 Months Between Smart Phone Based Telemonitoring Group and Control Group on Enhanced Usual Care|At baseline and follow-up visits, research assistants will collect the HSBP and HSBP readings of both groups at baseline, 3rd and 6th month FU. Regular home BP measurement is taken as the average of at least 3 or more BP measurement readings per week. The research assistant are not blinded and will collect the average of paper SBP and DBP measurement recordings ( if done) of the control group at baseline,at 3rd month and 6th month. The research assistant are not blinded and will collect the average of smartphone based SBP and DBP measurement recordings ( if done) and sent to the data center of the intervention group at baseline,at 3rd month and 6th month.|3 months|The mean average of the HSBP and HDBP of both groups who have taken and recorded their blood pressure readings at least 3x or more per week are collected||mmHg||Standard Deviation|Mean
650611|NCT02046993|Primary|Comparison of Mean Home Systolic and Diastolic Blood Pressure mHSBP and mHDBP Readings Between Intervention and Control Grp at Baseline|At baseline and follow-up visits, research assistants will collect the HSBP and HSBP readings of both groups at baseline, 3rd and 6th month FU. Regular home BP measurement is taken as the average of at least 3 or more BP measurement readings per week. The research assistant are not blinded and will collect the average of paper SBP and DBP measurement recordings ( if done) of the control group at baseline,at 3rd month and 6th month. The research assistant are not blinded and will collect the average of smartphone based SBP and DBP measurement recordings ( if done) and sent to the data center of the intervention group at baseline,at 3rd month and 6th month.|baseline|The mean average of the HSBP and HDBP of both groups who have taken and recorded their blood pressure readings at least 3x or more per week are collected||mmHg||Standard Deviation|Mean
650612|NCT02046993|Secondary|Self-efficacy for Managing Chronic Disease: 6 Items Scale (SEMCD-6 Items) Comparing Both Groups at 3 and 6 Months Post-intervention|This is a 6-items scale for measuring confidence of patients in self management of their chronic disease. Each item has a likert scale from 1 to 10 with 10 as most confident. Higher score indicating higher self-efficacy|6 months|||units on a scale||Standard Deviation|Mean
650613|NCT02046993|Primary|Change in Mean Clinic Systolic and Diastolic Blood Pressure CSBP and CDBP Readings at 3 and 6 Months From Baseline|At baseline and follow-up visits, research assistants who are blinded to allocation outcomes will meaure blood pressure after 15 minutes rest with validated electronic automated sphygmanometer ( ) . Four blood pressure readings taken at 1 minute interval will done for each subject and the mean of the second and third reading would be used for the primary outcome ,|baseline, 3rd month and 6 month|Intention to treat analysis was used and the last known data were carried forward to replace missing values for drop-outs.||mmHg||Standard Deviation|Mean
650614|NCT02046993|Primary|Percentage of Subjects Doing Home BP Monitoring|Percentage of subjects doing home BP monitoring with at least BP recordings of three or more times/week|Baseline, 3rd month, 6th month|||percentage of subjects doing HBPM|||Number
650615|NCT02046980|Primary|Conversion in Direction of Nystagmus From Apogeotropic to Geotropic or Disappearance of Nystagmus||2 days|217 patients enrolled in the study but 8 retracted their agreements.||participants|||Number
650616|NCT02046863|Primary|Percent Change From Baseline in Kinesia HomeView Symptom Ratings After Guided DBS Programming|Symptoms were first assessed with the implanted pulse generator (IPG) turned off for at least 30 minutes to allow the after-effects of stimulation to wear off (baseline). Symptoms were measured again with the IPG turned on at a setting that both minimized the average severity of tremor and bradykinesia and minimized side effects. The Kinesia score rated symptom severity (0, normal; 4, most severe) in four categories: tremor, finger tapping speed, finger tapping amplitude, and finger tapping rhythm. Scores for the four motor symptoms were averaged and converted to percent change from baseline.|Within two days of standard clinical DBS programming session|||Percentage change||Standard Deviation|Mean
650617|NCT02046772|Secondary|Time of Hospitalization|To see if the hospitalization time is shortened or not by the experimental treatment.|Up to 72 hours after the intervention|||participants|||Number
650618|NCT02046772|Secondary|Number of Adverse Events|To assess if the experimental treatment causes less, equal or more adverse events than the comparator treatment.|Up to 72 hours from the intervention and the hopitalary stay and during the next 7 days after discharge|||participants|||Number
650619|NCT02046772|Secondary|Greater and Earlier Mobilization Measured by Bromage Scale.|"To assess whether the administration of morphine chloride in addition to a low dose solution of local intradural anaesthetic (bupivacaine) improves the mobilization of the patients after surgery more than the single intradural administration of bupivacaine.
Total Score in the Bromage Scale goes from 1 to 5, where:
1: complete motor blocking - 2: capable to move the feet - 3: moves the feet and bends the knee - 4: raise the leg straight more or less than 30 degrees but no against resistance - 5: raise the leg straight more than 30 degrees against resistance (no motor blocking)"|During the first 24 hours after surgery and at the entry and exit of the resuscitation unit|||units on a scale||Standard Deviation|Mean
650620|NCT02046772|Primary|Measurement of the Analgesic Effect After Surgery by VAS From 0 to 10, Where 0 is no Pain and 10 is the Worst Pain Imaginable.|To compare whether the addition of morphine chloride to a low dose solution of bupivacaine and improves the analgesic treatment than a single administration of bupivacaine.|Up to 72 hours from the end of the surgery in the hospital stay and during the next 7 days at home, after discharge|||units on a scale||Standard Deviation|Mean
650624|NCT02046226|Primary|Rate of Wound Healing|Percentage reduction in target wound area (length x width).|3 months|Study subjects were not available to provide data when the primary outcome was to be reported, and thus there are no primary outcome data to report.|||||
650625|NCT02046200|Secondary|Stress-induced Alcohol Craving|Alcohol Urge Questionnaire (AUQ)|pre-post exposure to an imaginal stress script|The stress paradigm (pre-post exposure to an imaginal stress script) was not implemented from the outset of the study due to feasibility reasons. In particular, the investigators were concerned that the timing of the stress exposure might contaminate the effects of the alcohol administration.|||||
650626|NCT02046200|Secondary|Ivermectin Pharmacokinetics: Half-life (T1/2)|This study will collect blood samples for pharmacokinetic (PK) and pharmacodynamic profiling in order to examine whether IVM metabolism corresponds to its effects on alcohol response. Half-life of ivermectin (T1/2), measured in hours, provided below.|Hours post-drug administration: 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 48|||hours||Standard Deviation|Mean
650627|NCT02046200|Secondary|Ivermectin Pharmacokinetics: Area Under the Time-concentration Curve (AUC)|This study will collect blood samples for pharmacokinetic (PK) and pharmacodynamic profiling in order to examine whether IVM metabolism corresponds to its effects on alcohol response. Area under the time-concentration curve (AUC) from 0 to 48 hours after IVM administration, provided below.|Hours post-drug administration: 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 48|All randomized subjects included.||ng*h/mL||Standard Deviation|Mean
650628|NCT02046200|Secondary|Ivermectin Pharmacokinetics: Time to Cmax (Tmax)|This study will collect blood samples for pharmacokinetic (PK) and pharmacodynamic profiling in order to examine whether IVM metabolism corresponds to its effects on alcohol response. Time to Cmax (Tmax), measured in hours, provided below.|Hours post-drug administration: 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 48|All randomized subjects included.||hours||Standard Deviation|Mean
650629|NCT02046200|Secondary|Ivermectin Pharmacokinetics: Peak Concentration (Cmax)|This study will collect blood samples for pharmacokinetic (PK) and pharmacodynamic profiling in order to examine whether IVM metabolism corresponds to its effects on alcohol response. Maximum plasma concentration (Cmax), measured in ng/mL, provided below.|Hours post-drug administration: 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 48|All randomized subjects included.||ng/mL||Standard Deviation|Mean
650630|NCT02046200|Primary|Adverse Effects|Adverse effects will be monitored to determine the safe of combining IVM (30 mg) with moderate doses of alcohol (0.08 g/dl) using the Systematic Assessment for Treatment Emergent Effects (SAFTEE). The SAFTEE is a 24-item checklist in which the participant can identify whether a symptom is present (yes/no), its severity (mild, moderate, severe) and whether it was caused by the medication (yes/no). Data below represents a count of individual adverse effects reported on the SAFTEE during the alcohol infusion.|During alcohol infusion at BrAC = 0.00, 0.04, 0.08 g/dl|All randomized subjects included.||adverse effect count|||Number
650631|NCT02046200|Primary|Cue-induced Craving Using the Alcohol Urge Questionnaire (AUQ)|Cue-induced craving will be measured using the Alcohol Urge Questionnaire (AUQ), which consists of 8 items associated with urge to drink alcohol, rated on a 7 point scale (0 = strongly disagree, 6 = strongly agree). Item scores were averaged and the total score also ranges from 0-6.|6 hours post-medication administration|||scores on a scale||Standard Deviation|Mean
650632|NCT02046200|Primary|Subjective Effects of Alcohol Using the Biphasic Alcohol Effects Scale (BAES) - Sedative Subscale|Subjective effects of alcohol will be measured using the Biphasic Alcohol Effects Scale (BAES) , which consists of 14 items designed to capture the stimulant and sedative effects of alcohol, each rated on an 11-point scale (0 = not at all, 10 = extremely). The total score for the Sedative Subscale ranges from 0 to 70. Mean scores across subjects are reported below.|During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl period; which is expected to last approximately 6 hours.|All randomized subjects included.||scores on a scale||Standard Deviation|Mean
650633|NCT02046200|Primary|Subjective Effects of Alcohol Using the Biphasic Alcohol Effects Scale (BAES) - Stimulant Subscale|Subjective effects of alcohol will be measured using the Biphasic Alcohol Effects Scale (BAES) , which consists of 14 items designed to capture the stimulant and sedative effects of alcohol, each rated on an 11-point scale (0 = not at all, 10 = extremely). The total score for the Stimulant Subscale ranges from 0 to 70. Mean scores across all subjects are reported below.|During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl period; which is expected to last approximately 6 hours.|All randomized subjects included.||scores on a scale||Standard Deviation|Mean
650634|NCT02046200|Primary|"Subjective Effects of Alcohol Using the Drug Effects Questionnaire (DEQ) - High Subscale"|"Subjective effects of alcohol will be measured using the Drug Effects Questionnaire, which consists of 4 items that capture subjective effects, (feeling effects, liking effects, wanting more and being high). The question Are you high? was rated on an 11 point scale from 0 to 10 (higher values represent more effects)."|During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl period; which is expected to last approximately 6 hours.|All randomized subjects included.||scores on a scale||Standard Deviation|Mean
650635|NCT02046200|Primary|"Subjective Effects of Alcohol Using the Drug Effects Questionnaire (DEQ) - More Subscale"|"Subjective effects of alcohol will be measured using the Drug Effects Questionnaire, which consists of 4 items that capture subjective effects, (feeling effects, liking effects, wanting more and being high). The question Would you like more of the drug right now? was rated on an 11 point scale from 0 to 10 (higher values represent more effects)."|During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl period; which is expected to last approximately 6 hours.|All randomized subjects included.||scores on a scale||Standard Deviation|Mean
650636|NCT02046200|Primary|"Subjective Effects of Alcohol Using the Drug Effects Questionnaire (DEQ) - Like Subscale"|"Subjective effects of alcohol will be measured using the Drug Effects Questionnaire, which consists of 4 items that capture subjective effects, (feeling effects, liking effects, wanting more and being high). The question Do you like the effects you are feeling right now? was rated on an 11 point scale from 0 to 10 (higher values represent more effects)."|During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl period; which is expected to last approximately 6 hours.|All randomized subjects included.||scores on a scale||Standard Deviation|Mean
650637|NCT02046200|Primary|"Subjective Effects of Alcohol Using the Drug Effects Questionnaire (DEQ) - Feel Subscale"|"Subjective effects of alcohol will be measured using the Drug Effects Questionnaire, which consists of 4 items that capture subjective effects, (feeling effects, liking effects, wanting more and being high). The question Do you feel any drug effects? was rated on an 11 point scale from 0 to 10 (higher values represent more effects)."|During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl period; which is expected to last approximately 6 hours.|All randomized subjects included.||scores on a scale||Standard Deviation|Mean
650638|NCT02046200|Primary|Subjective Effects of Alcohol Using the Alcohol Urge Questionnaire (AUQ)|Subjective effects of alcohol will be measured using the Alcohol Urge Questionnaire (AUQ), which consists of 8 items associated with urge to drink alcohol, rated on a 7 point scale (1 = strongly disagree, 7 = strongly agree).|During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl period; which is expected to last approximately 6 hours.|All randomized subjects included.||scores on a scale||Standard Deviation|Mean
650639|NCT02046200|Primary|Diastolic Blood Pressure|"Blood pressure (measured in mmHg) will be monitored to determine the safety of combining IVM (30 mg) with moderate doses of alcohol (0.08 g/dl).
Blood pressure is measured at 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post-medication administration; and during alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl. During the infusion, the times for collecting BP will vary based on how long it takes participants to reach the targeted BrACs."|Post-medication administration (hours): 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48; During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl|All randomized subjects included.||mmHg||Standard Deviation|Mean
650640|NCT02046200|Primary|Systolic Blood Pressure|"Blood pressure (measured in mmHg) will be monitored to determine the safety of combining IVM (30 mg) with moderate doses of alcohol (0.08 g/dl).
Blood pressure is measured at 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post-medication administration; and during alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl. During the infusion, the times for collecting BP will vary based on how long it takes participants to reach the targeted BrACs."|Post-medication administration (hours): 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48; During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl|All randomized subjects included.||mmHg||Standard Deviation|Mean
650641|NCT02046200|Primary|Heart Rate|"Heart rate (measured in beats per minute; BPM) will be monitored to determine the safety of combining IVM (30 mg) with moderate doses of alcohol (0.08 g/dl).
During the infusion, the times for collecting HR will vary based on how long it takes participants to reach the targeted BrACs."|Post-medication administration (hours): 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48; During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl|All randomized subjects included.||BPM||Standard Deviation|Mean
654459|NCT01965288|Primary|Overall Stability|Assessment of Lens Fit Performance for overall lens stability. Collected at 2 weeks for each lens. (Excellent or Good.|2 weeks|All 60 subjects randomized to both sets of lenses.||percentage of lenses|Participants||Number
650735|NCT02045732|Primary|Number of Treatment-Emergent AEs and SAEs by Severity|AE severity was graded as mild, moderate, or severe. Mild AEs do not interfere with the participant's usual function. Moderate AEs interfere to some extent with the participant's usual function. Severe AEs interfere significantly with the participant's usual function.|Baseline through Day 127/Early Termination|The safety analysis population consists of all participants who received at least 1 dose of study drug.||adverse events|||Number
650670|NCT02045836|Secondary|Number of Subjects With Potential Immune Mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|During the period starting after 30 days post last vaccination up to study end (Month 3 – Month 14 for the Co-Ad Group &amp; Month 5 – Month 16 for the Control Group)|The analyses were performed on the Total Vaccinated cohort, which included all subjects with at least one administered vaccine and with the symptoms sheet filled in.||Participants|||Count of Participants
650671|NCT02045836|Secondary|Number of Subjects With Potential Immune Mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|From first vaccination up to 30 days post last vaccination (Month 0 – Month 3 for the Co-Ad Group &amp; Month 0 – Month 5 for the Control Group)|The analyses were performed on the Total Vaccinated cohort, which included all subjects with at least one administered vaccine and with the symptoms sheet filled in.||Participants|||Count of Participants
650672|NCT02045836|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From the first dose up to 30 days post last vaccination period|The analyses were performed on the Total Vaccinated cohort, which included all subjects with at least one administered vaccine and with the symptoms sheet filled in.||Participants|||Count of Participants
650673|NCT02045836|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|From the first dose up to 30 days post last vaccination period|||Participants|||Count of Participants
650674|NCT02045836|Secondary|Number of Days With Any Solicited Local and General Symptoms|The Co-Ad Group received only 2 vaccine doses, hence the number of participants for the Dose 3 categories in this group is 0.|Within 7 days (Days 0 - 6) after each vaccination|The analyses were performed on the Total Vaccinated cohort, which included all subjects with at least one administered vaccine and with the symptoms sheet filled in.||days||Inter-Quartile Range|Median
650675|NCT02045836|Secondary|Number of Subjects With Solicited Local Symptoms, Across Doses, by Vaccine|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|Within 7 days (Days 0 - 6) after vaccination|The analyses were performed on the Total Vaccinated cohort, which included all subjects with at least one administered vaccine and with the symptoms sheet filled in.||Participants|||Count of Participants
650676|NCT02045836|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. The Co-Ad Group received only 2 vaccine doses.|Within 7 days (Days 0 - 6) after each vaccination|The analyses were performed on the Total Vaccinated cohort, which included all subjects with at least one administered vaccine and with the symptoms sheet filled in.||Participants|||Count of Participants
650677|NCT02045836|Primary|Adjusted GMCs Between Groups|The Adjusted ratios of GMCs between groups (Control group and Co-Ad group) was presented for anti-gE antibody ELISA concentrations|At 1 month after last vaccine dose|This analysis was perfrmed on the According-to-Protocol (ATP) cohort for immunigenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the procedures and intervals allowed for the analysis, not eliminated during the study and for whom data concerning immunogenicity endpoint measures were available.||mIU/mL||95% Confidence Interval|Geometric Mean
650678|NCT02045836|Primary|Adjusted Ratios of Geometric Mean Titers (GMTs) Between Groups|The Adjusted ratios of GMTs between groups (Control group and Co-Ad group) were presented for each individual pneumococcal conjugate serotype Opsonophagocytic Activity (OPA).|At 1 month after vaccination|This analysis was perfrmed on the According-to-Protocol (ATP) cohort for immunigenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the procedures and intervals allowed for the analysis, not eliminated during the study and for whom data concerning immunogenicity endpoint measures were available.||Titers||95% Confidence Interval|Geometric Mean
650679|NCT02045836|Primary|Anti-pneumococcal Antibody Titers|Anti-pneumococcal antibody titers were presented as geometric mean titers (GMTs) for the 12 following serotypes as determined by Opsonophagocytic Assay (OPA): 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F.|At one month post-dose (Month 1)|This analysis was perfrmed on the According-to-Protocol (ATP) cohort for immunigenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the procedures and intervals allowed for the analysis, not eliminated during the study and for whom data concerning immunogenicity endpoint measures were available.||Titers||95% Confidence Interval|Geometric Mean
650680|NCT02045836|Primary|Anti-glicoprotein E (gE) Antibody Concentrations|Antibody concentrations were determined by ELISA, presented as geometric mean concentrations and expressed as milli international units per milliliter (mIU/mL).|At one month post-dose 2 (Month 3 for the Co-Ad Group and Month 5 for the Control Group)|This analysis was perfrmed on the According-to-Protocol (ATP) cohort for immunigenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the procedures and intervals allowed for the analysis, not eliminated during the study and for whom data concerning immunogenicity endpoint measures were available.||mIU/mL||95% Confidence Interval|Geometric Mean
650681|NCT02045836|Primary|Number of Subjects With a Vaccine Response for Anti-gE Antibodies|"Vaccine response rate for anti-gE antibody concentrations, as determined by enzyme-linked immunosorbent assay (ELISA), in subjects from the Co-Ad group. Vaccine response defined as :
For initially seronegative subjects, antibody concentration at post-vaccination ≥ 4 fold the cut-off for Anti-gE (4x97 mIU/mL) For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration"|At Month 3|This analysis was perfrmed on the According-to-Protocol (ATP) cohort for immunigenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the procedures and intervals allowed for the analysis, not eliminated during the study and for whom data concerning immunogenicity endpoint measures were available.||Participants|||Count of Participants
650682|NCT02045797|Secondary|Number of Participants With Abnormal Urinalysis Dipstick Results|Samples for urinalysis assessment was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28 for Glucose, Ketones, Occult Blood, Protein and pH. Participants with abnormal urinalysis result was reported.|Up to day 28|Safety Population. Only those participants available at the indicated time points were analyzed.||Participants|||Count of Participants
650683|NCT02045797|Secondary|Change From Baseline in Hematology Parameters: Hematocrit|Blood samples for assessment of hematology parameter of hematocrit was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.|Baseline (Day 1) up to Day 28|Safety Population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.||Ratio||Standard Deviation|Mean
650684|NCT02045797|Secondary|Change From Baseline in Hematology Parameters: Erythrocytes|Blood samples for assessment of hematology parameter of erythrocyte was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.|Baseline (Day 1) up to Day 28|Safety Population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.||Trillion cells per liter||Standard Deviation|Mean
650685|NCT02045797|Secondary|Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Volume (EMCV)|Blood samples for assessment of hematology parameter of EMCV was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.|Baseline (Day 1) up to Day 28|Safety Population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.||Femtoliter||Standard Deviation|Mean
650686|NCT02045797|Secondary|Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin (EMCH)|Blood samples for assessment of hematology parameter of EMCH was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.|Baseline (Day 1) up to Day 28|Safety Population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.||Picograms||Standard Deviation|Mean
650687|NCT02045797|Secondary|Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin|Blood samples for assessment of hematology parameters of EMCHC and hemoglobin was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.|Baseline (Day 1) up to Day 28|Safety Population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.||Gram per liter||Standard Deviation|Mean
650688|NCT02045797|Secondary|Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets|Blood samples for assessment of hematology parameters of basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.|Baseline (Day 1) up to Day 28|Safety Population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.||Giga cells per liter||Standard Deviation|Mean
650689|NCT02045797|Secondary|Estradiol Values at Baseline|Blood samples for assessment of clinical chemistry parameter of estradiol was collected at Baseline (Day 1). No post-baseline values were reported.|Baseline (Day 1)|Safety Population. Only those participants available at the indicated time points were analyzed.||Picomole per liter||Standard Deviation|Mean
650690|NCT02045797|Secondary|Change From Baseline in Clinical Chemistry Parameters: Creatinine Clearance, Estimated|Blood samples for assessment of clinical chemistry parameter of estimated creatinine clearance was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.|Baseline (Day 1) up to Day 28|Safety Population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.||Milliliter per minute||Standard Deviation|Mean
650691|NCT02045797|Secondary|Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea|Blood samples for assessment of clinical chemistry parameters of calcium, carbon dioxide, chloride, glucose, magnesium, potassium, sodium and urea was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.|Baseline (Day 1) up to Day 28|Safety population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.||Millimole per liter||Standard Deviation|Mean
650692|NCT02045797|Secondary|Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate|Blood samples for assessment of clinical chemistry parameters of bilirubin, creatinine, direct bilirubin and urate was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.|Baseline (Day 1) up to Day 28|Safety population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.||Micromoles per liter||Standard Deviation|Mean
650693|NCT02045797|Secondary|Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein|Blood samples for assessment of clinical chemistry parameters of albumin and total protein was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.|Baseline (Day 1) up to Day 28|Safety population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.||Gram per liter||Standard Deviation|Mean
650694|NCT02045797|Secondary|Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT)|Blood samples for assessment of clinical chemistry parameters of ALT, ALP, AST, FSH and GGT was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.|Baseline (Day 1) up to Day 28|Safety population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.||International units per liter||Standard Deviation|Mean
650695|NCT02045797|Secondary|Number of Participants With Maximum Post-Baseline Electrocardiogram (ECG) Readings|The 12-lead ECGs was obtained at Day 1, Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28 for corrected QT, using Fridericia formula (QTcF), corrected QT using Bazett’s formula (QTcB) and QRS intervals. The number of participants with maximum post-baseline ECG value exceeding the following limits have been reported: QTcB/QTcF interval > 450 and ≤ 480 millisecond (msec), QTcB/QTcF interval > 480 and ≤ 500 msec, QTcB/QTcF interval > 500 msec, QRS interval < 70 msec and QRS interval > 120 msec.|Up to Day 28|Safety Population. Only those participants available at the indicated time points were analyzed.||Participants|||Count of Participants
650696|NCT02045797|Secondary|Change From Baseline in Vital Sign: Body Temperature|Body temperature was measured with the participant in a supine or semi-supine position, having rested in that position for at least 10 minutes. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.|Baseline (Day 1) up to Day 28|Safety population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.||Celcius||Standard Deviation|Mean
650697|NCT02045797|Secondary|Change From Baseline in Respiratory Rate|Respiratory rate was measured with the participant in a supine or semi-supine position, having rested in that position for at least 10 minutes. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.|Baseline (Day 1) up to Day 28|Safety population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.||Breaths per minute||Standard Deviation|Mean
650923|NCT02040532|Primary|Reason for Non-tolerability and Discontinuation of Gabapentin|Reason why subjects who initiated treatment with gabapentin chose to discontinue before study completion|Baseline, Week 4 Visit, and study completion at 7 weeks|Four subjects initiated treatment with gabapentin but discontinued prior to study completion due to side effects.||Participants|||Count of Participants
650698|NCT02045797|Secondary|Change From Baseline in Pulse Rate|Pulse rate was measured with the participant in a supine or semi-supine position, having rested in that position for at least 10 minutes. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.|Baseline (Day 1) up to Day 28|Safety population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.||Beats per minute||Standard Deviation|Mean
650699|NCT02045797|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|SBP and DBP was measured with the participant in a supine or semi-supine position, having rested in that position for at least 10 minutes. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.|Baseline (Day 1) up to Day 28|Safety population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.||Millimeters of mercury||Standard Deviation|Mean
650700|NCT02045797|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, medically significant or all events of possible drug-induced liver injury with hyperbilirubinemia.|Up to Day 28|Safety population comprised the same set of participants from MITT population and received at least one dose of study medication.||Participants|||Count of Participants
650701|NCT02045797|Secondary|Number of Participants Demonstrating a Decrease in GSK2140944 Susceptibility When Comparing Isolates Recovered From Baseline With Those From Any Time Post-Baseline Skin Specimens|Reduction in susceptibility was defined as a >=4-fold increase in minimum inhibitory concentration (MIC) or >=6 millimeter decrease in zone size between an isolate obtained at Baseline and the same pathogen at subsequent visits.|Up to Day 28|Modified MITT Population.||Participants|||Count of Participants
650702|NCT02045797|Secondary|PK Parameters (From GSK2140944 Plasma Concentration-time Data): AUC (0-t) and AUC(0-tau) on Oral Dose Therapy|Samples for assessment of PK parameters AUClast and AUC0-tau was done at predose, 1, 2, 3 hours after first orally administered drug and one predose time point anytime from Day 7 to 10. The AUC 0-t and AUC0-tau was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. Data for participants while on oral dose therapy has been presented.|Predose, 1, 2, 3 hours after first orally administered drug and Day 7 to 10 (predose)|PK Parameter Population. Only those participants available at the indicated time points were analyzed.||Hour nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
650703|NCT02045797|Secondary|PK Parameters (From GSK2140944 Plasma Concentration-time Data): Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Time of the Last Quantifiable Concentration [AUC (0-t)] and AUC Over the Dosing Interval [AUC(0-tau)] on IV Therapy|Samples for assessment of PK parameters AUClast and AUC0-tau was done at predose, 1, 2, 2.5, 3, 6, 12 hours post dose on Day 1 to 3. The AUC 0-t and AUC0-tau was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. Data for participants while on IV therapy has been presented.|Predose, 1, 2, 2.5, 3, 6, 12 hours post dose on Day 1 to 3|PK Parameter Population. Only those participants available at the indicated time points were analyzed.||Hour nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
650704|NCT02045797|Secondary|PK Parameters (From GSK2140944 Plasma Concentration-time Data): Tmax on Oral Dose Therapy|Samples for assessment of PK parameter tmax was done at Predose, 1, 2, 3 hours after first orally administered drug and one predose time point anytime from Day 7 to 10. The time at which Cmax was observed was determined directly from the raw concentration-time data. Data for participants while on oral dose therapy has been presented.|Predose, 1, 2, 3 hours after first orally administered drug and Day 7 to 10 (predose)|PK Parameter Population. Only those participants available at the indicated time points were analyzed.||Hours||Full Range|Median
650705|NCT02045797|Secondary|PK Parameters (From GSK2140944 Plasma Concentration-time Data): Time to Cmax (Tmax) on IV Therapy|Samples for assessment of PK parameter tmax was done at predose, 1, 2, 2.5, 3, 6, 12 hours post dose on Day 1 to 3. The time at which Cmax was observed was determined directly from the raw concentration-time data. Data for participants while on IV therapy has been presented.|Predose, 1, 2, 2.5, 3, 6, 12 hours post dose on Day 1 to 3|PK Parameter Population. Only those participants available at the indicated time points were analyzed.||Hours||Full Range|Median
650706|NCT02045797|Secondary|PK Parameters (From GSK2140944 Plasma Concentration-time Data): Cmax on Oral Dose Therapy|Samples for assessment of PK parameter Cmax was done at Predose, 1, 2, 3 hours after first orally administered drug and one predose time point anytime from Day 7 to 10. The first occurrence of the Cmax was determined directly from the raw concentration-time data. Data for participants while on oral dose therapy has been presented.|Predose, 1, 2, 3 hours after first orally administered drug and Day 7 to 10 (predose)|PK Parameter Population. Only those participants available at the indicated time points were analyzed.||Nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
650707|NCT02045797|Secondary|Pharmacokinetic (PK) Parameters (From GSK2140944 Plasma Concentration-time Data): Maximum Observed Concentration (Cmax) on IV Therapy|Samples for assessment of PK parameter Cmax was done on at predose, 1, 2, 2.5, 3, 6, 12 hours post dose on Day 1 to 3. The first occurrence of the Cmax was determined directly from the raw concentration-time data. Data for participants while on IV therapy has been presented.|Predose, 1, 2, 2.5, 3, 6, 12 hours post dose on Day 1 to 3|PK Parameter Population consisted of all participants in the PK concentration population for whom valid and evaluable PK parameters were derived. Only those participants available at the indicated time points were analyzed.||Nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
650940|NCT02039778|Primary|Progression-free Survival|The progression-free survival of patients with newly diagnosed HGG treated with concurrent ScRT and temozolomide, followed by post-radiation temozolomide (and compare to historical controls).|12 months|no data available due to no subject completed the study. data not collected|||||
650708|NCT02045797|Secondary|Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for SA, MRSA and All Gram-positive Aerobic Pathogens in Blood Sample|Microbiological outcome was determined by comparing Baseline blood culture, to culture results at final follow up visit. Corresponding response (success or failure) was then assigned. Microbiological eradication was culture documented elimination of Baseline pathogens from a bacteriology specimen taken at final follow up visit. Presumed microbiological eradication was when there was a clinical success and no bacteriological specimen was obtained at final follow up visit. Culture documented presence of Baseline pathogens in a bacteriology specimen taken at final follow up visit was microbiological recurrence. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at final follow up visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine. Data for SA, MRSA and all Gram-positive aerobic pathogens in lesion sample has been presented.|Day 21 to Day 28|Modified Microbiological ITT population.||Number of pathogens|||Number
650709|NCT02045797|Secondary|Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for All Gram-positive Aerobic Pathogens in Lesion Sample|Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at final follow up visit. Corresponding response (success or failure) was then assigned. Microbiological eradication was culture documented elimination of Baseline pathogens from a bacteriology specimen taken at final follow up visit. Presumed microbiological eradication was when there was a clinical success and no bacteriological specimen was obtained at final follow up visit. Culture documented presence of Baseline pathogens in a bacteriology specimen taken at final follow up visit was microbiological recurrence. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at final follow up visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine. Data for all Gram-positive aerobic pathogens in lesion sample has been presented.|Day 21 to Day 28|Modified Microbiological ITT population.||Number of pathogens|||Number
650710|NCT02045797|Secondary|Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for Other Gram-positive Aerobic Pathogens in Lesion Sample|Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at final follow up visit. Corresponding response (success or failure) was then assigned. Microbiological eradication was culture documented elimination of Baseline pathogens from a bacteriology specimen taken at final follow up visit. Presumed microbiological eradication was when there was a clinical success and no bacteriological specimen was obtained at final follow up visit. Culture documented presence of Baseline pathogens in a bacteriology specimen taken at final follow up visit was microbiological recurrence. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at final follow up visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine. Data for other Gram-positive aerobic pathogens in lesion sample has been presented.|Day 21 to Day 28|Modified Microbiological ITT population.||Number of pathogens|||Number
650711|NCT02045797|Secondary|Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for MSSA in Lesion Sample|Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at final follow up visit. Corresponding response (success or failure) was then assigned. Microbiological eradication was culture documented elimination of Baseline pathogens from a bacteriology specimen taken at final follow up visit. Presumed microbiological eradication was when there was a clinical success and no bacteriological specimen was obtained at final follow up visit. Culture documented presence of Baseline pathogens in a bacteriology specimen taken at final follow up visit was microbiological recurrence. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at final follow up visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine. Data for MSSA pathogen in lesion sample has been presented.|Day 21 to Day 28|Modified Microbiological ITT population.||Number of pathogens|||Number
650712|NCT02045797|Secondary|Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for MRSA in Lesion Sample|Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at final follow up visit. Corresponding response (success or failure) was then assigned. Microbiological eradication was culture documented elimination of Baseline pathogens from a bacteriology specimen taken at final follow up visit. Presumed microbiological eradication was when there was a clinical success and no bacteriological specimen was obtained at final follow up visit. Culture documented presence of Baseline pathogens in a bacteriology specimen taken at final follow up visit was microbiological recurrence. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at final follow up visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine. Data for MRSA pathogen in lesion sample has been presented.|Day 21 to Day 28|Modified Microbiological ITT population.||Number of pathogens|||Number
650713|NCT02045797|Secondary|Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for SA Pathogen in Lesion Sample|Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at final follow up visit. Corresponding response (success or failure) was then assigned. Microbiological eradication was culture documented elimination of Baseline pathogens from a bacteriology specimen taken at final follow up visit. Presumed microbiological eradication was when there was a clinical success and no bacteriological specimen was obtained at final follow up visit. Culture documented presence of Baseline pathogens in a bacteriology specimen taken at final follow up visit was microbiological recurrence. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at final follow up visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine. Data for SA pathogen in lesion sample has been presented.|Day 21 to Day 28|Modified Microbiological ITT.||Number of pathogens|||Number
650751|NCT02045264|Primary|Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of Icatibant and Metabolites|AUCinf is the area under the plasma concentration versus time curve extrapolated from time 0 to infinity, calculated using the observed value of the last non-zero concentration. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Over 48 hours post-dose|The Pharmacokinetic Set consisted of all subjects who had taken the single dose of icatibant and for whom the primary pharmacokinetic data were considered sufficient and interpretable.||ng*hr/mL||Standard Deviation|Mean
650714|NCT02045797|Secondary|Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for SA, MRSA and All Gram-positive Aerobic Pathogens in Blood Sample|Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at post therapy visit. Corresponding response (success or failure) was then assigned. Microbiological eradication or persistence was culture documented elimination or presence of Baseline pathogens from a specimen taken at post therapy visit respectively. Presence of pathogens which was presumed to be eradicated at early efficacy visit was microbiological recurrence. Presumed microbiological eradication or persistence was when there was a clinical success or failure and no bacteriological specimen was obtained post therapy respectively. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at post therapy visit for pathogens presumed eradicated at early efficacy visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine.|Day 12 to Day 18|Modified Microbiological ITT population.||Number of pathogens|||Number
650715|NCT02045797|Secondary|Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for All Gram-positive Aerobic Pathogens in Lesion Sample|Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at post therapy visit. Corresponding response (success or failure) was then assigned. Microbiological eradication or persistence was culture documented elimination or presence of Baseline pathogens from a specimen taken at post therapy visit respectively. Presence of pathogens which was presumed to be eradicated at early efficacy visit was microbiological recurrence. Presumed microbiological eradication or persistence was when there was a clinical success or failure and no bacteriological specimen was obtained post therapy respectively. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at post therapy visit for pathogens presumed eradicated at early efficacy visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine.|Day 12 to Day 18|Modified Microbiological ITT population.||Number of pathogens|||Number
650716|NCT02045797|Secondary|Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for Other Gram-positive Aerobic Pathogens in Lesion Sample|Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at post therapy visit. Corresponding response (success or failure) was then assigned. Microbiological eradication or persistence was culture documented elimination or presence of Baseline pathogens from a specimen taken at post therapy visit respectively. Presence of pathogens which was presumed to be eradicated at early efficacy visit was microbiological recurrence. Presumed microbiological eradication or persistence was when there was a clinical success or failure and no bacteriological specimen was obtained post therapy respectively. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at post therapy visit for pathogens presumed eradicated at early efficacy visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine.|Day 12 to Day 18|Modified Microbiological ITT population.||Number of pathogens|||Number
650717|NCT02045797|Secondary|Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for MSSA in Lesion Sample|Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at post therapy visit. Corresponding response (success or failure) was then assigned. Microbiological eradication or persistence was culture documented elimination or presence of Baseline pathogens from a specimen taken at post therapy visit respectively. Presence of pathogens which was presumed to be eradicated at early efficacy visit was microbiological recurrence. Presumed microbiological eradication or persistence was when there was a clinical success or failure and no bacteriological specimen was obtained post therapy respectively. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at post therapy visit for pathogens presumed eradicated at early efficacy visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine. Data for MSSA in lesion sample has been presented.|Day 12 to Day 18|Modified Microbiological ITT population.||Number of pathogens|||Number
650718|NCT02045797|Secondary|Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for MRSA in Lesion Sample|Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at post therapy visit. Corresponding response (success or failure) was then assigned. Microbiological eradication or persistence was culture documented elimination or presence of Baseline pathogens from a specimen taken at post therapy visit respectively. Presence of pathogens which was presumed to be eradicated at early efficacy visit was microbiological recurrence. Presumed microbiological eradication or persistence was when there was a clinical success or failure and no bacteriological specimen was obtained post therapy respectively. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at post therapy visit for pathogens presumed eradicated at early efficacy visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine. Data for MRSA in lesion sample has been presented.|Day 12 to Day 18|Modified Microbiological ITT population.||Number of pathogens|||Number
650719|NCT02045797|Secondary|Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for SA Pathogen in Lesion Sample|Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at post therapy visit. Corresponding response (success or failure) was then assigned. Microbiological eradication or persistence was culture documented elimination or presence of Baseline pathogens from a specimen taken at post therapy visit respectively. Presence of pathogens which was presumed to be eradicated at early efficacy visit was microbiological recurrence. Presumed microbiological eradication or persistence was when there was a clinical success or failure and no bacteriological specimen was obtained at post therapy respectively. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at post therapy visit for pathogens presumed eradicated at early efficacy visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine. Data for SA in lesion sample has been presented.|Day 12 to Day 18|Modified Microbiological ITT population.||Number of pathogens|||Number
650752|NCT02045264|Primary|Drug Concentration Half-Life (T1/2) of Icatibant and Metabolites|The time it takes for the blood plasma concentration of a substance to halve.|Over 48 hours post-dose|The Pharmacokinetic Set consisted of all subjects who had taken the single dose of icatibant and for whom the primary pharmacokinetic data were considered sufficient and interpretable.||hr||Standard Deviation|Mean
650720|NCT02045797|Secondary|Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for SA, MRSA and All Gram-positive Aerobic Pathogens in Blood Sample|The microbiological outcome was determined by comparing Baseline bacteriology blood culture, to the culture results at early efficacy visit. The corresponding microbiological response (success or failure) by participant was then assigned. Microbiological eradication or persistence was defined as culture documented elimination or presence of Baseline pathogens from a bacteriology specimen taken at early efficacy visit respectively. Participant was considered to have outcome of presumed microbiological eradication or persistence when the participant was a clinical success or clinical failure and no bacteriological specimen was obtained at early efficacy visit respectively. When the determination of Baseline pathogen microbiological response could not be made, the outcome was considered as unable to determine. The data for SA, MRSA and all Gram-positive aerobic pathogens in blood sample has been presented.|Up to Day 3|Modified Microbiological ITT population.||Number of pathogens|||Number
650721|NCT02045797|Secondary|Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for All Gram-positive Aerobic Pathogens in Lesion Sample|The microbiological outcome was determined by comparing Baseline bacteriology lesion sample, to the culture results at early efficacy visit. The corresponding microbiological response (success or failure) by participant was then assigned. Microbiological eradication or persistence was defined as culture documented elimination or presence of Baseline pathogens from a bacteriology specimen taken at early efficacy visit respectively. Participant was considered to have outcome of presumed microbiological eradication or persistence when the participant was a clinical success or clinical failure and no bacteriological specimen was obtained at early efficacy visit respectively. When the determination of Baseline pathogen microbiological response could not be made, the outcome was considered as unable to determine. The data for all Gram-positive aerobic pathogens in lesion sample has been presented.|Up to Day 3|Modified Microbiological ITT population.||Number of pathogens|||Number
650722|NCT02045797|Secondary|Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Other Gram-positive Aerobic Pathogens in Lesion Sample|The microbiological outcome was determined by comparing Baseline bacteriology lesion sample, to the culture results at early efficacy visit. The corresponding microbiological response (success or failure) by participant was then assigned. Microbiological eradication or persistence was defined as culture documented elimination or presence of Baseline pathogens from a bacteriology specimen taken at early efficacy visit respectively. Participant was considered to have outcome of presumed microbiological eradication or persistence when the participant was a clinical success or clinical failure and no bacteriological specimen was obtained at early efficacy visit respectively. When the determination of Baseline pathogen microbiological response could not be made, the outcome was considered as unable to determine. The data for other Gram-positive aerobic pathogens in lesion sample has been presented.|Up to Day 3|Modified Microbiological ITT population.||Number of pathogens|||Number
650723|NCT02045797|Secondary|Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Methicillin-susceptible Staphylococcus Aureus (MSSA) in Lesion Sample|The microbiological outcome was determined by comparing Baseline bacteriology lesion sample, to the culture results at early efficacy visit. The corresponding microbiological response (success or failure) by participant was then assigned. Microbiological eradication or persistence was defined as culture documented elimination or presence of Baseline pathogens from a bacteriology specimen taken at early efficacy visit respectively. Participant was considered to have outcome of presumed microbiological eradication or persistence when the participant was a clinical success or clinical failure and no bacteriological specimen was obtained at early efficacy visit respectively. When the determination of Baseline pathogen microbiological response could not be made, the outcome was considered as unable to determine. The data for MSSA in lesion sample has been presented.|Up to Day 3|Modified Microbiological ITT population.||Number of pathogens|||Number
650724|NCT02045797|Secondary|Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Methicillin-resistant Staphylococcus Aureus (MRSA) in Lesion Sample|The microbiological outcome was determined by comparing Baseline bacteriology lesion sample, to the culture results at early efficacy visit. The corresponding microbiological response (success or failure) by participant was then assigned. Microbiological eradication or persistence was defined as culture documented elimination or presence of Baseline pathogens from a bacteriology specimen taken at early efficacy visit respectively. Participant was considered to have outcome of presumed microbiological eradication or persistence when the participant was a clinical success or clinical failure and no bacteriological specimen was obtained at early efficacy visit respectively. When the determination of Baseline pathogen microbiological response could not be made, the outcome was considered as unable to determine. The data for MRSA in lesion sample has been presented.|Day 3|Modified Microbiological ITT population.||Number of pathogens|||Number
650725|NCT02045797|Secondary|Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Staphylococcus Aureus (SA) Pathogen in Lesion Sample|The microbiological outcome was determined by comparing Baseline bacteriology lesion sample, to the culture results at early efficacy visit. The corresponding microbiological response (success or failure) by participant was then assigned. Microbiological eradication or persistence was defined as culture documented elimination or presence of Baseline pathogens from a bacteriology specimen taken at early efficacy visit respectively. Participant was considered to have outcome of presumed microbiological eradication or persistence when the participant was a clinical success or clinical failure and no bacteriological specimen was obtained at early efficacy visit respectively. When the determination of Baseline pathogen microbiological response could not be made, the outcome was considered as unable to determine. The data for SA in lesion sample has been presented.|Up to Day 3|Modified Microbiological ITT consisted of all randomized participants who received at least one dose of study medication and had a Gram-positive pathogens identified from their Baseline bacteriology lesion sample.||Number of pathogens|||Number
650753|NCT02045264|Primary|Time to Peak Plasma Concentration (Tmax) of Icatibant and Metabolites|Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached.|Over 48 hours post-dose|The Pharmacokinetic Set consisted of all subjects who had taken the single dose of icatibant and for whom the primary pharmacokinetic data were considered sufficient and interpretable.||hr||Standard Deviation|Mean
650941|NCT02039778|Primary|Overall Survival|The overall survival of patients with newly diagnosed high-grade glioma (HGG) treated with concurrent ScRT and temozolomide, followed by post-radiation temozolomide (and compare to historical controls).|12 months|||Participants|||Count of Participants
650726|NCT02045797|Secondary|Number of Participants With Clinical Response and Outcome at the Final Follow up Visit (Day 21-28)|The assessment was used to determine whether to continue the participant in the study. Clinical response was assessed as either a clinical success or a clinical failure and the clinical outcome was subsequently determined programmatically, based on the clinical response. Clinical success was defined as no increase in the total surface area of the lesion (as calculated by digital imaging) compared to post therapy visit and no further administration of antibacterial therapy for the lesion under study. Clinical recurrence was defined as death of participant; increase in the area of the lesion compared to post therapy visit or administration of additional antibacterial therapy for the lesion under study before the efficacy endpoint assessment for participants who were a clinical success at post therapy visit. In addition when the participant refused to consent to clinical examination, the clinical outcome was assessed as unable to determine with subsequent response as failure.|Day 21 to Day 28|MITT population.||Participants|||Count of Participants
650727|NCT02045797|Secondary|Number of Participants With Clinical Response and Outcome at the Post Therapy Visit (Day 12-18)|The assessment was used to determine whether to continue the participant in the study. Clinical response was assessed as either a clinical success or a clinical failure and the clinical outcome was subsequently determined programmatically, based on the clinical response. Clinical success was defined as a reduction in the total surface area of the lesion (as calculated by digital imaging) of >=20% compared to Baseline and no administration of additional antibacterial therapy for the lesion under study. Clinical failure was defined as death of participant; increase or insufficient decrease (i.e., <20%) in the area (as calculated by digital imaging) of the lesion or administration of non-trial antibacterial drug therapy for treatment of the lesion under study before the primary efficacy endpoint assessment. In addition when the participant refused to consent to clinical examination, the clinical outcome was assessed as unable to determine with subsequent response as failure.|Day 12 to Day 18|MITT population.||Participants|||Count of Participants
650728|NCT02045797|Secondary|Number of Participants With Clinical Response and Outcome at Early Efficacy Visit|The assessment was used to determine whether to continue the participant in the study. Clinical response was assessed as either a clinical success or a clinical failure and the clinical outcome was subsequently determined programmatically, based on the clinical response. Clinical success was defined as a reduction in the total surface area of the lesion (as calculated by digital imaging) of >=20% compared to Baseline and no administration of additional antibacterial therapy for the lesion under study. Clinical failure was defined as death of participant; increase or insufficient decrease (i.e., <20%) in the area (as calculated by digital imaging) of the lesion or administration of non-trial antibacterial drug therapy for treatment of the lesion under study before the primary efficacy endpoint assessment. In addition when the participant refused to consent to clinical examination, the clinical outcome was assessed as unable to determine with subsequent response as failure.|Up to Day 3|MITT population.||Participants|||Count of Participants
650729|NCT02045797|Primary|Number of Participants With Composite of the Cure Rate as Measured by Clinical Response and Outcome at the Early Efficacy Visit Combined With Withdrawal Rate|Cure rate and withdrawal rate data points was jointly assessed in a composite endpoint for all participants who received at least one dose of GSK2140944. Cure rate was defined as the percentage of participants exhibiting clinical improvement (=>20% reduction in overall lesion area) at the early efficacy visit. Withdrawal rate was defined as the percentage of participants who withdrew from study treatment due to a drug-related adverse event (AE) at any point while on treatment.|Up to Day 3|Modified Intent-to-Treat (MITT) population consisted of all randomized participants who received at least one dose of study medication.||Participants|||Count of Participants
650730|NCT02045732|Secondary|Concentration of PF-06342674||Baseline through Day 127/Early Termination|Participants in the placebo arm did not receive PF-06342674. Due to the early termination of the study, the small enrollment number and minimal data, concentration data were listed but not summarized, and pharmacokinetic (PK) parameters were not calculated for the PF-06342674 0.25 mg/kg arm.||nanogram/milliliter (ng/ml)||Geometric Coefficient of Variation|Geometric Mean
650731|NCT02045732|Primary|Number of Participants With Confirmed Positive Anti-Drug Antibodies (ADAs)|Assays for the determination of a positive immune response was performed. An antibody immune response was defined as a confirmed post-treatment positive enzyme-linked immunosorbent assay (ELISA) result in combination with a negative baseline sample ELISA result. ADA positive was defined as ADA titer (ie, the reciprocal of the highest dilution that gives a value equivalent to the cut point of the assay) >=4.32.|Baseline, and Days 15, 29, 57, 85 and Day 127/Early Termination|The safety analysis population consists of all participants who received at least 1 dose of study drug.||participants|||Number
650732|NCT02045732|Primary|Number of Participants With Abnormal Electrocardiogram (ECG)|Criteria for potential clinical concern in ECG parameters: The maximum of the beginning of the Q wave to the end of the T wave corresponding to electrical systole (QT) interval corrected using the Fridericia formula (QTcF) >=450 milliseconds (msec), maximum QTcF interval change from baseline in range of 30 to <60 msec and >=60 msec.|Baseline through Day 127/Early Termination|The safety analysis population consists of all participants who received at least 1 dose of study drug. The QTcF interval of the participant in the placebo arm was in this range of 450 to <480 msec at Baseline. This participant experienced a decrease in QTcF of 30 to <60 msec on Day 30, which then returned to baseline levels on Day 57.||participants|||Number
650733|NCT02045732|Primary|Number of Participants With Clinically Significant Changes in Vital Signs|Categorical summarization criteria in vital signs included: supine systolic blood pressure (SBP) of <90 millimeters of mercury (mm Hg) or change in supine SBP of >=30 mm Hg; supine diastolic blood pressure (DBP) of <50 mm Hg or change in supine DBP of >=20 mm Hg; supine pulse rate of <40 or more than (>)120 beats per minute (bpm).|Baseline through Day 127/Early Termination|The safety analysis population consists of all participants who received at least 1 dose of study drug.||participants|||Number
650734|NCT02045732|Primary|Number of Participants With Clinical Laboratory Abnormalities|Number of participants with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters included hematology, liver function, renal function, electrolytes, hormones, clinical chemistry, and urinalysis (dipstick and microscopy). Abnormal laboratory findings included: lymphocytes (absolute) less than (<)0.8 x lower limit of normal (LLN); urine blood/hemoglobin (qualitative) more than or equal to (>=)1; urine nitrite >=1; urine leukocyte esterase >=1; urine red blood cell (RBC) >=20/high-power field (HPF).|Baseline through Day 127/Early Termination|The safety analysis population consists of all participants who received at least 1 dose of study drug.||participants|||Number
650736|NCT02045732|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Withdrawals Due to AEs|An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs are events between first dose of study drug and up to Day 127/Early Termination that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs.|Baseline through Day 127/Early Termination|The safety analysis population consists of all participants who received at least 1 dose of study drug.||participants|||Number
650737|NCT02045511|Secondary|Change From Baseline in SF-36 Physical Component at 3 Months|"Mean change, Unpooled - comparing baseline to 3 month follow-up visit
Measure collected via one-on-one interview conducted by trained data collectors.
Standard scoring can be found at http://www.rand.org/health/surveys_tools/mos/36-item-short-form/scoring.html.
Higher scores indicate better physical health functioning; U.S. population norm: M = 50, SD = 9.95, range = [4-71]."|3 months|||units on a scale||Standard Deviation|Mean
650738|NCT02045511|Secondary|Change From Baseline in SF-36 Mental Component at 3 Months|"Mean change, Unpooled - comparing baseline to 3 month follow-up visit
Data were collected via one-on-one interviews with trained data collectors.
Standard scoring can be found at http://www.rand.org/health/surveys_tools/mos/36-item-short-form/scoring.html.
Higher scores indicate better mental health functioning; U.S. population norm: M = 50.0, SD = 10.0, range = [2-74]."|3 months|||units on a scale||Standard Deviation|Mean
650739|NCT02045511|Secondary|Change From Baseline in PHQ-9 at 3 Months|"Mean change, Unpooled - comparing baseline to 3 month follow-up visit
[1] Measure Description: Measure collected via one-on-one interview conducted by trained data collectors.
Total of 9 questions, scored from 0 to 3. The score from each question are summed to a total score, which can range from 0 to 27.
Interpretation of Total Score Total Score Depression Severity 0 No depression 1-4 Minimal depression 5-9 Mild depression 10-14 Moderate depression 15-19 Moderately severe depression 20-27 Severe depression.
Change from baseline to 3 months was reported. An increase in the score from baseline to three months (a positive number) indicates a worsening in depression severity. A decrease in the score from baseline to three months (a negative number) indicates a reduction in depression severity."|3 months|||units on a scale||Standard Deviation|Mean
650740|NCT02045511|Secondary|Change From Baseline in Revised UCLA at 3 Months|"Mean change, Unpooled - comparing baseline to 3 month follow-up visit
[1] Measure Description: Measure was collected via a one-on-one interview conducted by a trained data collector.
20-item Likert-type scale. Total score is sum of the 20 items, scores range from 20 to 80. Lower values equate to lower levels of loneliness and higher values equate to higher levels of loneliness.
Perry et al., 1990 uses the following score ranges:
20-34 - Low degree of loneliness 35-49 - Moderate degree of loneliness 50-64 - Moderately high degree of loneliness 65-80 - High degree of loneliness"|3 months|||units on a scale||Standard Deviation|Mean
650741|NCT02045511|Secondary|Change From Baseline in Revised QDS at 3 Months|"Mean change, Unpooled - comparing baseline to 3 month follow-up visit
[1] Measure Description: Measure was collected through a one-on-one interview conducted by a trained data collector.
Survey includes 5 questions, scored Strongly disagree, Slightly disagree, neither, slightly agree, or strongly agree (1, 2, 3, 4, 5)
Scoring is from 1 (worst) to 5 (best). Scores were summed across each of the 5 survey questions resulting in a total range of 5 (worst) to 25 (best)
Although utilized in multiple studies, including Yueh et al., 2001, there are no numerical anchors for what would represent a clinically important difference."|3 months|||units on a scale||Standard Deviation|Mean
650742|NCT02045511|Primary|Change From Baseline in Hearing Handicap Inventory for the Elderly (HHIE)-S at 3 Months|"Mean change, Unpooled - comparing baseline to 3 month follow-up visit
Measure Description: Measure was collected through a one-on-one interview with a trained data collector.
Scoring:
0-8 suggests no hearing handicap 10-24 suggests mild-moderate hearing handicap 26-40 suggests significant hearing handicap"|3 months|||units on a scale||Standard Deviation|Mean
650743|NCT02045264|Secondary|Change From Baseline in Pulse Rate||Over 48 hours post-dose|The Safety Set consisted of all subjects who had taken the single dose of icatibant.||beats per minute||Standard Deviation|Mean
650744|NCT02045264|Secondary|Change From Baseline in Systolic Blood Pressure||Over 48 hours post-dose|The Safety Set consisted of all subjects who had taken the single dose of icatibant.||mmHg||Standard Deviation|Mean
650745|NCT02045264|Secondary|Change From Baseline in Diastolic Blood Pressure||Over 48 hours post-dose|The Safety Set consisted of all subjects who had taken the single dose of icatibant.||mmHg||Standard Deviation|Mean
650746|NCT02045264|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-t) of Icatibant and Metabolites|AUC0-t is the area under the plasma concentration versus time curve extrapolated from time 0 to to the last quantifiable concentration. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Over 48 hours post-dose|The Pharmacokinetic Set consisted of all subjects who had taken the single dose of icatibant and for whom the primary pharmacokinetic data were considered sufficient and interpretable.||ng*hr/mL||Standard Deviation|Mean
650747|NCT02045264|Secondary|Safety Evaluation Measured by Percentage of Subjects With Not Clinically Significant Abnormalities in ECG Results||Over 48 hours post-dose|The Safety Set consisted of all subjects who had taken the single dose of icatibant.||percentage of participants|||Number
650748|NCT02045264|Secondary|The Percentage of Subjects With Any Injection Site Reactions.||Over 48 hours post-dose|The Safety Set consisted of all subjects who had taken the single dose of icatibant.||percentage of participants|||Number
650749|NCT02045264|Secondary|The Total Number of Treatment-Emergent Adverse Events|Treatment-emergent adverse events (TEAEs) were those that started after the single dose of icatibant.|TEAEs were collected after the single dose of icatibant until follow up, 5-7 days after icatibant administration|The Safety Set consisted of all subjects who had taken the single dose of icatibant.||Treatment Emergent Adverse Events|||Number
650750|NCT02045264|Primary|Total Body Clearance (CL/F) of Icatibant|The rate at which a drug is removed from the body.|Over 48 hours post-dose|The Pharmacokinetic Set consisted of all subjects who had taken the single dose of icatibant and for whom the primary pharmacokinetic data were considered sufficient and interpretable.||mL/hr||Standard Deviation|Mean
650754|NCT02045264|Primary|Peak Plasma Concentration (Cmax) of Icatibant and Metabolites|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Over 48 hours post-dose|The Pharmacokinetic Set consisted of all subjects who had taken the single dose of icatibant and for whom the primary pharmacokinetic data were considered sufficient and interpretable.||ng/mL||Standard Deviation|Mean
650755|NCT02045238|Secondary|Incidence of Adverse Effects|Any adverse effects directly attributable to treatment shall be noted. Mere lack of improve or worsening of symptoms attributable to the disease clinical course will not be considered as adverse effects.|24 hours|Number of patients too small to achieve statistical significance||participants|||Number
650756|NCT02045238|Secondary|Rate of Readmission After Discharge|The mere attendance to the Emergency Department will not be isolately considered, as it may be due to a scheduled reevaluation.|5 days||||||
650757|NCT02045238|Secondary|Time to Discharge|Actual time to discharge was considered of secondary importance as it can be influenced by individual considerations like patient age or time of the day.|24 hours||||||
650758|NCT02045238|Primary|Time to Attain Discharge Criteria|Discharge criteria are: Room air saturation >94% AND respiratory rate < 60 AND Respiratory Distress Assessment Instrument (RDAI) score inferior than 4, maintained over a 4 hour period.|24 hours||||||
650759|NCT02045238|Primary|Rate of Admission|Patients staying longer than 24h are considered to be admitted to ward.|24 hours|Number of participants analyzed was too small to obtain statistic significance||participants|||Number
650760|NCT02044991|Secondary|Disability|Disability is measured at baseline (0 weeks) and week 8 using the Oswestry Disability Index (ODI), which is a measure of low back pain that ranges from 0 points to 100 with higher scores indicating greater disability. The change in disability between these two time points (i.e., the difference score) is compared between the two groups.|8 weeks|The trial was prematurely terminated in February 2017 due to poor recruitment. No statistical analysis is conducted.||change score on the ODI scale||Full Range|Median
650761|NCT02044991|Secondary|Pelvic Functioning|Pelvic functioning is measured at baseline (0 weeks) and week 8 using the Pelvic Girdle Questionnaire (PGQ), which ranges from 0 to 100 points with higher scores revealing greater pelvic girdle pain. The change in pelvic functioning between these two time points (i.e., the difference score) is compared between the two groups.|8 weeks|The trial was prematurely terminated in February 2017 due to poor recruitment. No statistical analysis is conducted.||change score on the PGQ scale||Full Range|Median
650762|NCT02044991|Primary|Change in Pain|Pain is measured using the Pain Numeric Rating Scale (NRS), which ranges from 0 to 10 with higher scores indicating greater pain. This measure is recorded at baseline (0 weeks) and 8 weeks. The change in pain between these two time points (i.e., the difference score) is compared between the two groups.|8 weeks|The trial was prematurely terminated in February 2017 due to poor recruitment. No statistical analysis is conducted.||change score on the NRS pain scale||Full Range|Median
650763|NCT02044848|Primary|Stimulated C-peptide in Response to a Standard Mixed Meal Tolerance Test|Study was terminated and no data were collected for the Outcome Measure.|Week 52|Study was terminated and no data were collected for the Outcome Measure|||||
650764|NCT02044822|Secondary|Minimal Residual Disease Negativity Rate at Week 36|Minimal residual disease (MRD) negativity rate was defined as the proportion of participants with MRD < 10^-4 assessed by flow cytometry in bone marrow at Week 36 after therapy initiation. For participants receiving the final dose of rituximab after the original scheduled date, the MRD assessment will be performed no fewer than 12 weeks after the last dose of rituximab.||Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.|||||
650765|NCT02044822|Secondary|Overall Survival|Overall survival was defined as the interval from the start of study treatment to death from any cause.||Due to the early termination of the study, efficacy data were not mature for all participants, and therefore the prespecified analyses were not conducted.|||||
650766|NCT02044822|Secondary|Progression-Free Survival|Progression-free survival (PFS) was defined as the interval from first dose of study drug to the first documentation of definitive disease progression or death from any cause. Definitive disease progression is CLL progression based on standard criteria, excluding lymphocytosis alone. PFS was to be assessed by an IRC.||Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.|||||
650767|NCT02044822|Secondary|Complete Response Rate|Complete response rate was defined as the proportion of participants who achieve a confirmed complete response. Complete response rate was to be assessed by an IRC.||Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.|||||
650768|NCT02044822|Secondary|Nodal Response Rate|Nodal response rate was defined as the proportion of participants who achieve a 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters of index lesions. Nodal response rate was to be assessed by an IRC.||Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.|||||
650769|NCT02044822|Secondary|Duration of Response|Duration of response (DOR) was defined as the interval from the first documentation of confirmed complete response or partial response (by IRC) to the first documentation of definitive disease progression or death from any cause. Definitive disease progression is chronic lymphocytic leukemia (CLL) progression based on standard criteria, excluding lymphocytosis alone.||Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.|||||
650770|NCT02044822|Primary|Overall Response Rate|Overall response rate (ORR) was defined as the proportion of participants who achieve a confirmed complete or partial response. ORR was to be assessed by an independent review committee (IRC).||Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.|||||
650771|NCT02044458|Other Pre-specified|Failure Rates of the Placement of a Foley Catheter|To compare the failure rate of the placement of a Foley catheter for the induction of labor in women randomly allocated to rigid stylette or no stylette|Followed throughout patient's hospital stay, approximately 10 days|||failed attempt|||Number
655252|NCT01953328|Secondary|Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL||Weeks 10 and 12|Full analysis set||percentage of participants||95% Confidence Interval|Number
650772|NCT02044458|Secondary|Pain Assessed by Visual Analog Scale (VAS)|To compare the pain assessed by visual analogue scale(VAS), in women randomly allocated to ridged stylette or no ridged stylette. Patient-assessed pain level was determined by verbally asking patients to assess their pain (on a scale from 0-10 [no pain-worst pain]) following taping of the catheter tail. Pain was only assessed once.|Followed throughout patient's hospital stay, approximately 10 days|The pain level of one successful attempt with stylette was not recorded.||units on a scale||95% Confidence Interval|Mean
650773|NCT02044458|Primary|Duration of Insertion Between Foley Catheter Groups With and Without a Stylette.|Difference in insertion times between women randomly allocated to ridged stylette or no ridged stylette. Patient's may have experienced multiple insertions only if a patient failed initial randomized insertion method. Subsequent treatment methods were used when a patient failed and time was summarized as length of time of attempt. Failure was defined as either inadvertent amniotomy, excessive time in placement (subjectively determined by the provider using the catheter), or excessive patient pain (subjectively defined by the provider but based on patient response).|Followed throughout patient's hospital stay, approximately 10 days|The insertion time of two failed attempts with no stylette were not recorded.||minutes||Inter-Quartile Range|Median
650774|NCT02044393|Secondary|AUC0-infinity (Area Under the Concentration-time Curve of BI 691751 in Plasma and Whole Blood Over the Time Interval From 0 Extrapolated to Infinity)|AUC0-infinity (area under the concentration-time curve of BI 691751 in plasma and whole blood over the time interval from 0 extrapolated to infinity).|from day 1 to 31 days postdose relative to BI 691751 administration time: -2:00, 0:10, 0:20, 0:40, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 47:00, 71:00, 95:00, 119:00, 143:00, 215:00, 287:00, 383:00, 551:00, 719:00h.|PKS||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
650775|NCT02044393|Primary|Cmax (Maximum Measured Concentration of BI 691751 in Plasma and Whole Blood)|Cmax (maximum measured concentration of BI 691751 in plasma and whole blood).|From day 1 to 31 days postdose relative to BI 691751 administration (h:min): -2:00, 0:10, 0:20, 0:40, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 47:00, 71:00, 95:00, 119:00, 143:00, 215:00, 287:00, 383:00, 551:00, 719:00h.|PKS||nmol/L||Geometric Coefficient of Variation|Geometric Mean
650776|NCT02044393|Primary|AUC0-tz (Area Under the Concentration-time Curve of BI 691751 in Plasma and Whole Blood Over the Time Interval From 0 up to the Last Quantifiable Concentration)|AUC0-tz: area under the concentration-time curve of BI 691751 in plasma and whole blood over the time interval from 0 up to the last quantifiable concentration.|from day 1 to 31 days postdose relative to BI 691751 administration (h:min): -2:00, 0:10, 0:20, 0:40, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 47:00, 71:00, 95:00, 119:00, 143:00, 215:00, 287:00, 383:00, 551:00, 719:00h.|Pharmacokinetic Set (PKS): included all subjects from the TS who provided at least one primary or secondary pharmacokinetic endpoint in any period that is judged as evaluable for pharmacokinetics and is not affected by protocol violations relevant to the statistical evaluation of bioavailability||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
650777|NCT02044380|Primary|Safety Assesment|"Safety was assessed by:
All serious adverse events (SAEs)
All adverse events (AEs) leading to treatment discontinuation or dose reduction of afatinib
Non-serious AEs assessed by the treating physician as related to afatinib."|From first administration of treatment until 28 days after last drug administration, up to 80 weeks.|Treated set||Percentage of participants|||Number
650778|NCT02044367|Secondary|Palatability Rating for Pellets (on Food) and Oral Solution Will be Assessed by Asking the Subjects 1 Multiple Choice Verbal Question.|"Palatability question: How do you rank the taste? with 5 possible answers: Very good - Good - Fair - Acceptable - Not acceptable."|once on day 3 (48 hours after first dose)|Treated set including all subjects that provided at least 1 observation for at least 1 of the questions for at least 1 of the test products.||participants|||Number
650779|NCT02044367|Secondary|Acceptability Rating for Pellets (on Food) and Oral Solution Will be Assessed by Asking the Subjects 1 Multiple Choice Verbal Question.|"Acceptability question: Would you accept to take this medication for chronic use? with 3 possible answers: Yes - No - I am not sure."|once on day 3 (48 hours after first dose)|Treated set including all subjects that provided at least 1 observation for at least 1 of the questions for at least 1 of the test products.||participants|||Number
650780|NCT02044367|Secondary|Maximum Measured Concentration of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t for Free Dabigatran.|Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t for free dabigatran.|47:55, 48:30, 49:00, 49:30, 50:00, 50:30, 51:00, 51:30, 52:00, 54:00, 56:00, 58:00, 60:00 relative to first drug administration|Pharmacokinetic analysis set (PKS) included all treated subjects that provided at least 1 observation for at least 1 primary or secondary PK endpoint without relevant protocol deviations with respect to the statistical evaluation of PK endpoints.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
650781|NCT02044367|Secondary|Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t for Free Dabigatran.|Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t for free dabigatran.|47:55, 48:30, 49:00, 49:30, 50:00, 50:30, 51:00, 51:30, 52:00, 54:00, 56:00, 58:00, 60:00 relative to first drug administration|Pharmacokinetic analysis set (PKS) included all treated subjects that provided at least 1 observation for at least 1 primary or secondary PK endpoint without relevant protocol deviations with respect to the statistical evaluation of PK endpoints.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
650782|NCT02044367|Primary|Maximum Measured Concentration of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t for Total Dabigatran.|Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t for total dabigatran.|47:55, 48:30, 49:00, 49:30, 50:00, 50:30, 51:00, 51:30, 52:00, 54:00, 56:00, 58:00, 60:00 relative to first drug administration|Pharmacokinetic analysis set (PKS) included all treated subjects that provided at least 1 observation for at least 1 primary or secondary PK endpoint without relevant protocol deviations with respect to the statistical evaluation of PK endpoints.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
650798|NCT02043808|Secondary|Major Extracranial Bleeding|"Event rate of major extracranial bleeding.
The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period."|From October 1, 2009 through July 31, 2013 (the study period).|All patients in the post-propensity score matching cohort||Events per 1000 person-years||95% Confidence Interval|Number
650783|NCT02044367|Primary|Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t for Total Dabigatran.|Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t for total dabigatran.|47:55, 48:30, 49:00, 49:30, 50:00, 50:30, 51:00, 51:30, 52:00, 54:00, 56:00, 58:00, 60:00 relative to first drug administration|Pharmacokinetic analysis set (PKS) included all treated subjects that provided at least 1 observation for at least 1 primary or secondary PK endpoint without relevant protocol deviations with respect to the statistical evaluation of PK endpoints.||ng∙h/mL||Geometric Coefficient of Variation|Geometric Mean
650784|NCT02044302|Secondary|Pain Score Questionnaire|The patient records their feeling of pain scaled in a subjective scale from 0 to 10. 0 means that there is no pain and 10 means that the worst pain. The other numbers mean that pain is perceived as in between. The investigator will also mark a pain score in the facial expression scale of Mosby© by evaluating your facial appearance.|Post Operation One Month|The study was terminated after 2 subjects enrolled and outcomes were never summarized.|||||
650785|NCT02044302|Secondary|Pain Score Questionnaire|The patient records their feeling of pain scaled in a subjective scale from 0 to 10. 0 means that there is no pain and 10 means that the worst pain. The other numbers mean that pain is perceived as in between. The investigator will also mark a pain score in the facial expression scale of Mosby© by evaluating your facial appearance.|Post Operation Week 1|The study was terminated after 2 subjects enrolled and outcomes were never summarized.|||||
650786|NCT02044302|Primary|Pain Score Questionnaire|The patient records their feeling of pain scaled in a subjective scale from 0 to 10. 0 means that there is no pain and 10 means that the worst pain you had. The other numbers mean that pain is in perceived as in between. The investigator will also mark a pain score in the facial expression scale of Mosby© by evaluating your facial appearance.|Post Operation Day 1|The study was terminated after 2 subjects enrolled and outcomes were never fully collected not summarized.|||||
650787|NCT02043808|Secondary|Death|"Event rate of death, due to any cause.
The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period."|From October 1, 2009 through July 31, 2013 (the study period).|All patients in the post-propensity score matching cohort||Events per 1000 person-years||95% Confidence Interval|Number
650788|NCT02043808|Secondary|Pulmonary Embolism|"Event rate of pulmonary embolism.
The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period."|From October 1, 2009 through July 31, 2013 (the study period).|All patients in the post-propensity score matching cohort||Events per 1000 person-years||95% Confidence Interval|Number
650789|NCT02043808|Secondary|Deep Vein Thrombosis|"Event rate of deep vein thrombosis.
The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period."|From October 1, 2009 through July 31, 2013 (the study period).|All patients in the post-propensity score matching cohort||Events per 1000 person-years||95% Confidence Interval|Number
650790|NCT02043808|Secondary|Venous Thromboembolism|"Event rate of venous thromboembolism.
The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period."|From October 1, 2009 through July 31, 2013 (the study period).|All patients in the post-propensity score matching cohort||Events per 1000 person-years||95% Confidence Interval|Number
650791|NCT02043808|Secondary|Myocardial Infarction|"Event rate of myocardial infarction.
The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period."|From October 1, 2009 through July 31, 2013 (the study period).|All patients in the post-propensity score matching cohort||Events per 1000 person-years||95% Confidence Interval|Number
650792|NCT02043808|Secondary|Transient Ischemic Attack|"Event rate of transient ischemic attacks.
The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period."|From October 1, 2009 through July 31, 2013 (the study period).|All patients in the post-propensity score matching cohort||Events per 1000 person-years||95% Confidence Interval|Number
650793|NCT02043808|Secondary|Major Other Bleeding|"Event rate of major other bleeding.
The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period."|From October 1, 2009 through July 31, 2013 (the study period).|All patients in the post-propensity score matching cohort||Events per 1000 person-years||95% Confidence Interval|Number
650794|NCT02043808|Secondary|Major Urogenital Bleeding|"Event rate of major urogenital bleeding.
The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period."|From October 1, 2009 through July 31, 2013 (the study period).|All patients in the post-propensity score matching cohort||Events per 1000 person-years||95% Confidence Interval|Number
650795|NCT02043808|Secondary|Major Lower GI Bleeding|"Event rate of major lower gastrointestinal (GI) bleeding.
The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period."|From October 1, 2009 through July 31, 2013 (the study period).|All patients in the post-propensity score matching cohort||Events per 1000 person-years||95% Confidence Interval|Number
650796|NCT02043808|Secondary|Major Upper GI Bleeding|"Event rate of major upper gastrointestinal (GI) bleeding.
The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period."|From October 1, 2009 through July 31, 2013 (the study period).|All patients in the post-propensity score matching cohort||Events per 1000 person-years||95% Confidence Interval|Number
650797|NCT02043808|Secondary|Major GI Bleeding|"Event rate of major gastrointestinal (GI) bleeding.
The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period."|From October 1, 2009 through July 31, 2013 (the study period).|All patients in the post-propensity score matching cohort||Events per 1000 person-years||95% Confidence Interval|Number
650820|NCT02043379|Secondary|Interferon-gamma Plasma Cytokine Levels|Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively.|Pre-operative to 48 hours post-operative|||pg/mL||Inter-Quartile Range|Median
650799|NCT02043808|Secondary|Major Intracranial Bleeding|"Event rate of major intracranial bleeding.
The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period."|From October 1, 2009 through July 31, 2013 (the study period).|All patients in the post-propensity score matching cohort||Events per 1000 person-years||95% Confidence Interval|Number
650800|NCT02043808|Secondary|Hemorrhagic Stroke|"Event rate of hemorrhagic stroke.
The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period."|From October 1, 2009 through July 31, 2013 (the study period).|All patients in the post-propensity score matching cohort||Events per 1000 person-years||95% Confidence Interval|Number
650801|NCT02043808|Secondary|Ischemic Stroke|"Event rate of ischemic stroke.
The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period."|From October 1, 2009 through July 31, 2013 (the study period)|All patients in the post-propensity score matching cohort||Events per 1000 person-years||95% Confidence Interval|Number
650802|NCT02043808|Primary|Major Bleeding|"Event rate of major bleeding.
The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period."|From October 1, 2009 through July 31, 2013 (the study period)|All patients in the post-propensity score matching cohort||Events per 1000 person-years||95% Confidence Interval|Number
650803|NCT02043808|Primary|Stroke (Hemorrhagic, Ischemic)|"Event rate of stroke (hemorrhagic, ischemic).
Variables in the final propensity score model: age, gender index year, baseline CHADS(2) score (Congestive heart failure, Hypertension, Age ≥75 years, Diabetes mellitus, Prior Stroke or transient ischemic attack (TIA) or Thromboembolism), baseline CHA(2)DS(2)-VASc score (Congestive heart failure, Hypertension, Age ≥75 years (doubled), Diabetes mellitus, Stroke (doubled), Vascular disease, Age 65–74 years, Sex category), baseline HAS-BLED score (Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile International Normalized Ratio, Elderly, Drugs/alcohol concomitantly), baseline use of several medications and presence of several baseline co-morbidities.
The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period."|From October 1, 2009 through July 31, 2013 (the study period)|All patients in the post-propensity score matching cohort||Events per 1000 person-years||95% Confidence Interval|Number
650804|NCT02043782|Primary|Degree of Leakage|The degree of leakage is investigated on a 32-point scale (including 0 for no leakage). O represents no leakage and 32 represents the worst leakage.|14 +/- 3 days|||units on a scale|Participants|Standard Deviation|Mean
650805|NCT02043379|Secondary|Lactic Acid||pre-operative through 24 hours post-operative|||mmol/L||Standard Deviation|Mean
650806|NCT02043379|Secondary|Serum Creatinine|Pre-operative and 48 hour post-operative maximum creatinine recorded.|48 hours|||mg/dL||Standard Deviation|Mean
650807|NCT02043379|Secondary|Immunoglobulin Concentration in Peritoneal Dialysis Drainage|Immunoglobulin concentration will be measured from chest tube and peritoneal drain every 4 hours for first 12 hours post-operative and 24 hours post-operative.|24 hours post-op|||mg/dL||Inter-Quartile Range|Median
650808|NCT02043379|Secondary|Tumor Necrosis Factor Plasma Cytokine Levels|Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively.|pre-operative through 48 hours post-operative|||pg/dL||Inter-Quartile Range|Median
650809|NCT02043379|Secondary|Interleukin-8 Plasma Cytokine Levels|Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively.|pre-operative through 48 hours post-operative|||pg/dL||Inter-Quartile Range|Median
650810|NCT02043379|Secondary|Interleukin-6 Plasma Cytokine Levels|Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively.|pre-operative through 48 hours post-operative|||pg/mL||Inter-Quartile Range|Median
650811|NCT02043379|Secondary|Interleukin-1b Plasma Cytokine Levels|Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively.|pre-operative through 48 hours post-operative|||pg/mL||Inter-Quartile Range|Median
650812|NCT02043379|Secondary|Interleukin-12p70 Plasma Cytokine Levels|Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively.|pre-operative through 48 hours post-operative|||pg/mL||Inter-Quartile Range|Median
650813|NCT02043379|Secondary|Interleukin-10 Plasma Cytokine Levels|Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively.|pre-operative through 48 hours post-operative|||pg/mL||Inter-Quartile Range|Median
650814|NCT02043379|Secondary|Respiratory Variables|Total time duration of post-operative length of mechanical ventilation until hospital discharge|until extubation, an average of 2 days|||hours||Inter-Quartile Range|Median
650815|NCT02043379|Secondary|Respiratory Variables|Time until first extubation in hours|until extubation, an average of 2 days|||hours||Inter-Quartile Range|Median
650816|NCT02043379|Secondary|Fluid Overload Variables|The following fluid overload variables will be assessed at 0-24 hours, 25-48 hours, and 0-48 hours post-cardiopulmonary bypass: blood product and albumin administration, chest tube output, urine output, peritoneal dialysis output, net fluid balance, and percent fluid overload.The total output the subject's produce (urine, chest tube, peritoneal drainage, etc.) will be subtracted from the total input (medications, blood products, albumin administration, etc) to determine the total fluid intake in milliliters. This total number will then be divided by the subject's weight in kilograms to determine the fluid overload in mL/kg.|0-48 hours post-CPB|||militers/kilogram||Inter-Quartile Range|Median
650817|NCT02043379|Secondary|Intensive Care Unit Length of Stay|The length of stay in the pediatric cardiac intensive care unit from admit post-operative until either discharge home, discharge to another unit/hospital/care facility, or death. This value is calculated in hours. Admit post-operative is recorded as hour 0.|1 month|||hours||Inter-Quartile Range|Median
650818|NCT02043379|Secondary|Mortality|Incidence of mortality from admit to Pediatric cardiac intensive care unit post-operatively until hospital discharge .|Approximately 1 month|||subjects|||Number
650819|NCT02043379|Secondary|Immunoglobulin Concentration in Chest Tube Drainage|Immunoglobulin concentration will be measured from chest tube every 4 hours for first 12 hours post-operative and then 24 hours post-operative.|24 hours post-op|||mg/dL||Inter-Quartile Range|Median
650821|NCT02043379|Secondary|Plasma Immunoglobulins|Plasma Immunoglobulin levels will be checked pre-operatively, 12 hours post-op and 5 days post-op|5 days post-op|||mg/dL||Standard Deviation|Mean
650824|NCT02043379|Secondary|Post-operative Inotrope Score|"The average admit, 12 hour, 24 hour, and 48 hour post-operative inotrope score will be calculated excluding Milrinone. To calculate the inotrope score the following formula was used: (Epinephrine/Norepinephrine dose in mcg/kg/min x 100) + (Dopamine dose in mcg/kg/min x 1) + (Phenylephrine dose in mcg/kg/min x 10) + (Vasopressin dose unit/kg/hr x 60/10000). The higher the inotrope score the more cardiac support the subject requires. There is not a normal scale or range used for this calculation."|first 48 hours post-CPB|||inotropic score||Inter-Quartile Range|Median
650825|NCT02043379|Secondary|Fluid Overload Variables|The following fluid overload variables will be assessed in milliliters per kilogram at 0-24 hours post-cardiopulmonary bypass: blood product and albumin administration, chest tube output, urine output, peritoneal dialysis output, net fluid balance, and percent fluid overload. The total output the subject's produce (urine, chest tube, peritoneal drainage, etc.) will be subtracted from the total input (medications, blood products, albumin administration, etc) to determine the total fluid intake in milliliters. This total number will then be divided by the subject's weight in kilograms to determine the fluid overload in mL/kg.|0-24 hours post-CPB|||mililiters/kilogram||Inter-Quartile Range|Median
650826|NCT02043379|Secondary|Post-operative Plasma Albumin|Plasma albumin will be assessed at 24 and 48 hours.|up to 48 hours post CPB|||g/dL||Standard Deviation|Mean
650827|NCT02043379|Primary|Blood Stream Infection Within 1 Week of Surgery||7 days|||subjects|||Number
650828|NCT02043379|Primary|Blood Stream Infection|Any positive blood culture during the post-operative period until hospital discharge|until Hospital Discharge, an average of 30 days|||subjects|||Number
650829|NCT02043379|Primary|Post-operative Infection|Any positive culture or treatment for culture negative sepsis within 1 week of surgery|within 1 week of surgery|||Subjects|||Number
650830|NCT02043379|Primary|Post-Operative Infections|The primary endpoint of this study is incidence of post-operative infections through hospital discharge|until Hospital Discharge, an average of 30 days|||subjects|||Number
650831|NCT02043366|Secondary|Normalized Area of Hyperalgesia Around the Incision|The skin around the incision is stimulated in steps of 5 mm at intervals of 1 s starting outside of the hyperalgesic area in the direction of the incision. The distance from the incision to the first point where a ‘painful’, ‘sore’ or ‘sharper’ feeling occurred is measured and noted. This measurement is repeated at predefined radial lines around the incision. To eliminate the variable length of incision, this length is subtracted from the longer diameter leaving four radial distances from the end and from the middle of the incision. The normalized area of hyperalgesia is calculated by summing up the areas of the remaining four triangles measured by and Von Frey filament.|24 hours after surgery|||cm^2||Standard Deviation|Mean
650832|NCT02043366|Secondary|Cumulative Sufentanyl Consumption|Each patient was administered analgesics using a PCA pump containing sufentanil (100μg) in normal saline at a total volume of 100 ml after leaving PACU. This device was set to deliver a basal infusion of 2 ml/h and bolus doses of 0.5 ml with a 15-min lockout period. Sufentanyl cumulative consumption is recorded 24 hours postoperatively|24 hours||||||
650833|NCT02043366|Secondary|Total Dose of First Postoperative Analgesic Requirement|First postoperative pain (NRS≥5) is initially controlled by titration of sufentanyl.|1 hour after surgery||||||
650834|NCT02043366|Secondary|Occurrence of Side Effects|Occurrence of side effects: nausea, vomiting, dizziness, headache, shivering, pruritus|24 hours||||||
650835|NCT02043366|Secondary|Time of First Postoperative Analgesic Requirement|First postoperative pain (NRS≥5) is initially controlled by titration of sufentanyl.|1 hour post surgery||||||
650836|NCT02043366|Secondary|Pain Score (NRS)|The pain score at rest was evaluated by pain 11-point numerical rating scale (NRS): 0 = no pain, 10 = greatest imaginable pain.|3h, 6h, 12h, and 24h after surgery||||||
650837|NCT02043366|Primary|Mechanical Hyperalgesia Threshold on the Dominant Inner Forearm|The mechanical hyperalgesia threshold was defined as the lowest force (g) necessary to bend a Von Frey filament, which was perceived to be painful by the patient and measured by Von Frey filament at 24 hours postoperatively|24 hours after surgery|||g||Standard Deviation|Mean
650838|NCT02043145|Primary|Change From Baseline in the Investigator Assessment of Glabellar Line Severity Using a 4-point Scale|The Investigator assessed the severity of the patient’s glabellar lines at maximum frown using the 4-point Facial Wrinkle Scale (FWS) where: 0=none, 1=mild, 2=moderate or 3=severe. A negative change from Baseline indicated improvement.|Pre-dose (Baseline), Post-dose (Up to 4 Years)|Efficacy population included all participants who were treated with BOTOX® as prescribed. Participants previously treated with survey drug (BOTOX®), who violated dose/administration or who were missing data were excluded.||score on a scale||Standard Deviation|Mean
650839|NCT02043145|Primary|Change From Baseline in the Modified Ashworth Scale (MAS) Using a 6-Point Scale|The MAS assessed the degree of muscle tone during movement of the upper limbs compared to normal muscle tone using a 6-point scale at where: 0=no increase in muscle tone, 1=Slight increase in muscle tone manifested by a catch and release or by minimal resistance at the end of the range of motion when the part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). A negative change from Baseline indicated improvement.|Pre-dose (Baseline), Post-dose (Up to 4 Years)|Efficacy population included all participants who were treated with BOTOX® as prescribed. Participants previously treated with survey drug (BOTOX®), who violated dose/administration or who were missing data were excluded.||score on a scale||Standard Deviation|Mean
650840|NCT02043145|Primary|Change From Baseline in the Hyperhidrosis Disease Severity Scale (HDSS) Using a 4-Point Scale|Participants assessed their underarm sweat using the 4-point HDSS where: 1=Never noticeable and never interferes with my daily activities, 2=Tolerable but sometimes interferes with my daily activities, 3=Barely tolerable and frequently interferes with my daily activities or 4=Intolerable and always interferes with my daily activities. A negative change from Baseline indicated improvement.|Pre-dose (Baseline), Post-dose (Up to 4 Years)|Efficacy population included all participants who were treated with BOTOX® as prescribed. Participants previously treated with survey drug (BOTOX®), who violated dose/administration or who were missing data were excluded.||score on a scale||Standard Deviation|Mean
663852|NCT01797029|Secondary|Percentage of Participants With Symptomatic, Laboratory-confirmed, Influenza Virus Infection (All Strains)||Through 16 to 19 months post-vaccination||||||
650841|NCT02043145|Primary|Number of Patients With Adverse Events (AEs) and Serious Adverse Drug Reactions (SADRs)|An AE was defined as any undesirable changes in medical findings (including laboratory test findings) identified during medical examinations as well as AEs associated with the study drug application that occurred during or after administration of the study drug, regardless of causal relationship to the study drug. A SADR was any drug reaction that: resulted in death or was life threatening, required hospitalization or prolonged hospitalization, caused persistent or significant disability/incapacity, caused a congenital anomaly/birth defect or other medically important event.|4 Years|Safety population included all participants treated with BOTOX® as prescribed. Participants previously treated with survey drug (BOTOX®) were excluded.||participants|||Number
650842|NCT02043132|Secondary|Number of Participants Experiencing Infection as a Surgical Site Complication|"The occurrence of the following systemic and surgical site complications within 6 weeks of surgery will be recorded. Data will be obtained from EMR and from patient at standard of care 2 week and 6 week follow-up appointment.
Infection"|up to 6-weeks post-operatively|||Participants|||Count of Participants
650843|NCT02043132|Secondary|Number of Participants Experiencing Hematoma as a Surgical Site Complication|"The occurrence of the following systemic and surgical site complications within 6 weeks of surgery will be recorded. Data will be obtained from EMR and from patient at standard of care 2 week and 6 week follow-up appointment.
Hematoma"|up to 6-weeks post-operatively|||Participants|||Count of Participants
650844|NCT02043132|Secondary|Number of Participants Experiencing Deep Vein Thrombosis|"The occurrence of the following systemic and surgical site complications within 6 weeks of surgery will be recorded. Data will be obtained from EMR and from patient at standard of care 2 week and 6 week follow-up appointment.
Deep venous thrombosis"|up to 6-weeks post-operatively|||Participants|||Count of Participants
650845|NCT02043132|Secondary|Number of Participants Experiencing Myocardial Infarction|"The occurrence of the following systemic and surgical site complications within 6 weeks of surgery will be recorded. Data will be obtained from EMR and from patient at standard of care 2 week and 6 week follow-up appointment.
Myocardial infarction"|up to 6-weeks post-operatively|||Participants|||Count of Participants
650846|NCT02043132|Secondary|Number of Participants Experiencing Pulmonary Embolism|"The occurrence of the following systemic and surgical site complications within 6 weeks of surgery will be recorded. Data will be obtained from EMR and from patient at standard of care 2 week and 6 week follow-up appointment.
Pulmonary Embolism"|up to 6-weeks post-operatively|||Participants|||Count of Participants
650847|NCT02043132|Primary|Total Drain Output|Total Drain Output as measured postoperatively 0-48 hours|0-48 hours postoperatively|||mL||95% Confidence Interval|Mean
650848|NCT02043132|Primary|Total Hemoglobin Loss|Total hemoglobin loss estimated using the formula for total blood volume described by Nadler et al Hb(loss) = blood volume (L) x [Hb(initial)(g/L) - Hb(final)(g/L)] + Hb(transfused)|Preoperative through Postoperative Days 1 and 2|||g||95% Confidence Interval|Mean
650849|NCT02043132|Primary|Total Blood Loss|Total Blood Loss as calculated according to method as described by Good et al. Total Blood Loss (mL) = 1000 X Hb(loss)/Hb(initial)|Preoperative through Postoperative Days 1 and 2|||Total Blood Loss (mL)||Standard Deviation|Mean
650850|NCT02042924|Primary|Percentage of Proliferating Bone Marrow in the Femur|The difference in the percentage of proliferating bone marrow between baseline and day 100 post transplant in the femur|100 days|Only one patient was enrolled in each cohort and therefore any analysis would not be meaningful.|||||
650851|NCT02042924|Primary|Difference in Water Fat|The difference in the water-fat MRI between baseline and day 100 post transplant in L4 and femoral neck.|100 days|Only one patient was enrolled in each cohort and therefore any analysis would not be meaningful.|||||
650852|NCT02042924|Primary|Difference in Percentage of Proliferating Bone Marrow Between Baseline and 100 Days|The difference in percentage of proliferating bone marrow will be calculated for the following sites: skull, proximal humeri, ribs, clavicles, cervical spine, thoracic spine, lumbar spine, sacrum, pelvis and proximal femur.|100 days|Only one patient was enrolled in each cohort and therefore any analysis would not be meaningful.|||||
650853|NCT02042911|Secondary|Number of Subjects With Clinically Significant Physical Examination Values|Number of subjects with abnormal or severe values of vital signs, electrocardiogram, and physical examination including ECOG performance status|Up to 30 months|||participants|||Number
650854|NCT02042911|Secondary|Number of Subjects With Clinically Significant Laboratory Test Values of Grade 3 or More|Abnormalities in laboratory test values in overall study period were analyzed. Severity of abnormalities were evaluated using Common Terminology Criteria for Adverse Events (CTCAE). grade 1 : mild grade 2 : moderate grade 3 : severe or medically significant but not immediately life-threatening grade 4 : life threatening or disabling grade 5 : death related to adverse event|Up to 30 months|||participants|||Number
650855|NCT02042911|Secondary|Adverse Events|All undesirable medical events experienced by the subject treated with the investigational product (including abnormal changes in laboratory values) are treated as adverse events and evaluated for safety.|Up to 30 months|||participants|||Number
650856|NCT02042911|Secondary|Overall Survival (OS)|The period from the date of patient registration to the date of death.|Up to 30 months|||months||95% Confidence Interval|Median
650857|NCT02042911|Secondary|Duration of Remission|The period from the day of CR or PR confirmation to recurrence/relapse.|Up to 30 months|||months||95% Confidence Interval|Median
650858|NCT02042911|Secondary|Progression-free Survival (PFS)|The period from the first day of the study drug administration (Day1) to progressive disease (PD), recurrence/relapse, or death.|Up to 30 months|||months||95% Confidence Interval|Median
650859|NCT02042911|Secondary|Complete Remission Rate (CR+CRi) Based on IWCLL Guideline||Up to 30 months|||Percentage of participants||95% Confidence Interval|Number
650885|NCT02041533|Secondary|Time to Response in Participants With PD-L1 Expression >= 5%|Time to Response (TTR) was defined as the time from randomization to the date of the first response (CR or PR), as assessed by IRRC assessment. TTR was evaluated for responders only. CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measureable disease and no new sites; Stable Disease (SD)= Failure to attain CR/PR or PD; Progressive Disease (PD)= Any new lesion or increase by >=50% of previously involved sites from nadir.|From date of randomization to date of first confirmed response (assessed up to August 2016, approximately 18 months)|All randomized participants with a confirmed response and PD-L1 expression >= 5%||months||Full Range|Median
663853|NCT01797029|Secondary|Safety Profile of LAIV: Protocol Defined Wheezing Illness||Through 16 to 19 months post-vaccination||||||
650860|NCT02042911|Secondary|National Cancer Institute-sponsored Working Group (NCI-WG) Response Rate (CR+nPR+PR) Based on IWCLL Guideline|"The criteria for nPR and PR based on IWCLL guideline are shown below.
nPR: Fulfills all CR criteria other than residual lymphoid nodules confirmed by bone marrow examination.
PR: Fulfills two or more items from Group A and one or more items from Group B for a minimal duration of 8 weeks.
Group A;
50% or greater reduction in lymphocyte count in peripheral blood from baseline
50% or greater reduction (size reduction) in Sum of the products of the greatest diameters (SPD) and no new lesion emergence or no new enlarged lymph node
A decrease in the size of the liver and/or spleen by 50% more
A decrease in marrow infiltration or lymphoid nodules by 50% more Group B;
1) Neutrophil count ＞1.5×10^9/L or 50% improvement from baseline 2) Platelet count ＞100×10^9/L or 50% improvement from baseline 3) Hemoglobin 11.0 g/dL or 50% improvement from baseline without transfusions"|Up to 30 months|||Percentage of participants||95% Confidence Interval|Number
650861|NCT02042911|Primary|Response Rate [Complete Remission (CR) +Complete Remission / Incomplete (CRi) + Nodular Partial Remission (nPR) + Partial Remission (PR)] Based on International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Guideline|"The criteria for CR, CRi, nPR and PR based on IWCLL guideline are shown below. For the criteria for nPR and PR, please refer to the description of NCI-WG response rate (CR+nPR+PR).
CR: Assessment should be made at least 8 weeks after completion of administration.
Absence of significant lymphadenopathy (lymph nodes greater than 1.5 cm in diameter)
No hepatomegaly or splenomegaly
Absence of B symptoms
Meet the following laboratory test values;
lymphocyte count in peripheral blood: ＜4.0×10^9/L
neutrophil count: ＞1.5×10^9/L
platelet count: 100×10^9/L
hemoglobin: 11.0 g/dL without transfusions
less than 30% of nucleated cells are lymphocytes (confirmed by bone marrow aspiration and no lymphoid nodules).
No new lesion emergence
CRi: Fulfills all of the following criteria
Delayed anemia, thrombocytopenia, or neutropenia is observed.
Fulfills all CR criteria other than 4).
Delayed symptoms are all judged to be caused by drug."|Up to 30 months|||Percentage of participants||95% Confidence Interval|Number
650862|NCT02042872|Secondary|Bone Mineral Density (BMD) at the Total Hip at Baseline and Month 12|An imaging method known as dual energy x-ray absorptiometry (DXA) was used to obtain BMD of the total hip.|Baseline and 12 months|||g/cm2||Standard Deviation|Mean
650863|NCT02042872|Primary|Bone Mineral Density (BMD) at the Distal Femur and Proximal Tibia at Baseline and Month 12.|An imaging method known as dual energy x-ray absorptiometry (DXA) was used to obtain BMD of the distal femur and proximal tibia by using a customized research software program supplied by the manufacturer. This measurement will be the primary determinant (dependent measure) of difference among the treatment and control groups, and they will be followed over time at the previously specified time points.|Baseline and 12 months|||g/cm2||Standard Deviation|Mean
650864|NCT02042534|Secondary|Number of Participants With Modified Rankin Score of 0 or 1 at Week 4|"modified Rankin Score
0 : No symptoms at all
: No significant disability despite symptoms; able to carry out all usual duties and activities
: Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance
: Moderate disability; requiring some help, but able to walk without assistance
: Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance
: Severe disability; bedridden, incontinent and requiring constant nursing care and attention
: Dead"|at 1 month|Modified ITT (mRS 0,1 at Week 4, n(%)||participants|||Number
650865|NCT02042534|Secondary|Length of Hospitalization|Time to event will be calculated|at 1month|||days||Standard Deviation|Mean
650866|NCT02042534|Secondary|The Number of Patients With Recurrent Ischemic Lesion|Recurrent ischemic lesion confirmed by relevant neuroimagings|at 1 month|Modified ITT||Participants|||Number
650867|NCT02042534|Secondary|The Number of Patients With Intracranial Bleeding|Intracranial bleeding confirmed by relevant neuroimagings|at 1 month|Modified ITT||Participants|||Number
650868|NCT02042534|Primary|Number of Participants With Intracranial Bleeding and/or Recurrent Ischemic Lesion as Confirmed by MRI Imaging|"Intracranial bleeding: symptomatic hemorrhage confirmed by CT or MRI or asymptomatic hemorrhage on follow-up GRE or SWI imaging at 1 month
Recurrent ischemic lesion: symptomatic ischemic stroke confirmed by relevant neuroimagings or asymptomatic recurrent ischemic lesion on follow-up or FLAIR imaging at 1 month"|1 month after randomization|"modified Intention to treat: 95 / 88 (Rivaroxaban/Warfarin)
Per protocol: 93 / 87 (Rivaroxaban/Warfarin)
Safety: 98 / 90 (Rivaroxaban/Warfarin)"||Participants|||Number
650869|NCT02042443|Secondary|Progression-free Survival|From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact.|Up to 2 years from registration|Eligible and analyzable patients.||months||95% Confidence Interval|Median
650870|NCT02042443|Secondary|Objective Response Rate|Confirmed response (CR) is two or more objective statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration. Partial response (PR) is two or more objective statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration. Unconfirmed CR is one objective status of CR documented before progression or symptomatic deterioration but not qualifying as CR or PR. Unconfirmed PR is one objective status of PR documented before progression or symptomatic deterioration but not qualifying as CR, PR or unconfirmed CR.|Up to 2 years from registration|All eligible and analyzable patients with measurable disease.||Participants|||Count of Participants
650871|NCT02042443|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Adverse event reporting followed the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.|Up to 2 years|Eligible patients who received any treatment and were assessed for adverse events are included in this summary. One patient was hospitalized prior to receiving protocol treatment and was not assessed for adverse events.||Participants|||Count of Participants
650872|NCT02042443|Primary|Overall Survival|From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Up to 2 years from registration|Eligible and analyzable patients.||months||95% Confidence Interval|Median
650873|NCT02042404|Other Pre-specified|Determine the Incidence of Serious Device- and Procedure-related Adverse Events.|The analysis of the incidence of serious device- and procedure-related adverse events through the study period. All adverse events will be recorded on case report forms and determinations will be made as to the whether the events are related to the investigational device.|120 days|Both Primary Cohort and Roll-in Cohort were included in all safety analyses.||serious device- or procedure-related AEs|||Number
650874|NCT02042404|Secondary|Change in Aided HINT 90 Speech Reception Thresholds (SRTs) When Compared to the Baseline Unaided Condition.|Change in aided HINT 90 speech reception thresholds (SRTs) when compared to the baseline unaided condition. SRTs will be measured using HINT materials with the signal (speech level presented from 0 degrees) adapted relative to the noise (presented from 90 degrees held fixed at 60 dB SPL) to determine the signal-to-noise ratio for reporting the whole sentence correct 50% of the time (Nilsson et al., 1994). An improvement in HINT score is indicated as a negative (-) dB value change. A more negative value indicating an improvement of understanding speech and noise. An improvement of -1dB is equivalent to a 10% improvement in understanding speech and noise and is likely of clinical benefit. HINT 90 will be measured twice and averaged to obtain the per subject HINT SRT. All subject data will be averaged to obtain the means. Analysis includes calculation of the unaided measurements (before device placement) minus the aided measurements.|Baseline and 30 days|39 subjects available for analysis between enrollment/treatment and 30 day measurement.||dB difference in HINT scores||Standard Deviation|Mean
650875|NCT02042404|Secondary|Functional Gain Over the Frequency Range From 2000 to 10,000 Hz|10 dB (decibel) change in the averaged pure tone thresholds for the subject population over the frequency range from 2000 to 10,000 Hz (2000, 3000, 4000, 6000, 8000, 9000 and 10,000 Hz). Measurement to be used in analysis are the baseline unaided soundfield thresholds measured prior to device placement and the aided soundfield thresholds measured at least 30 days post placement. Analysis includes calculation of the unaided soundfield thresholds minus aided soundfield thresholds.|Baseline and 30 days|39 subjects available for analysis between enrollment/treatment and 30 day measurement.||dB difference in Soundfield Hearing||Standard Deviation|Mean
650876|NCT02042404|Primary|Audiometric Safety as Shown by no Hearing Change Pre and Post Treatment|"The unaided air conduction hearing thresholds will be measured for each individual ear twice before device placement at Visit #1 and averaged to obtain the baseline unaided air conduction hearing thresholds, and the post wear unaided air conduction hearing thresholds will be measured after device removal at Visit #5. A PTA4 (Pure Tone Average at 4 frequencies; 500, 1000, 2000, and 4000 Hz) will be computed both for baseline unaided hearing pre-placement and unaided hearing post-removal for each ear, then averaged across both ears for each subject . A determination of No Hearing Change for the subject population will be made if the calculated Hearing Changes of the subject population are 10 dB or less."|Baseline and 120 days|43 subjects available for analysis between enrollment/treatment and 120 day measurement.||dB difference in Unaided Hearing||Standard Deviation|Mean
650877|NCT02042404|Primary|Change in Mean Aided Word Recognition Scores (WRS) When Compared to the Baseline Unaided Condition.|Change in mean aided Word Recognition Scores (WRS) when compared to the baseline unaided condition. WRS will be measured using 50-word NU-6 (Northwestern University Auditory Test No.6) recorded materials, presented at 45 dB Hearing Level on a per-ear basis with the test ear isolated for measurement and the results, expressed as a percentage of words correct, averaged across the two ears for each subject. All subject data will then be averaged to obtain the means. The baseline unaided measurements will occur prior to device placement, and the aided condition will be measured at least 30 days post device placement.|Baseline and 30 days|39 subjects available for analysis between enrollment/treatment and 30 day measurement.||percentage of words correctly identified||Standard Deviation|Mean
650878|NCT02042274|Secondary|Blood Glucose|Blood glucose levels measured at distinct time points: baseline, after 3 months supplementation, and after a 2 month wash out period.|Baseline, 3 months, 5 months|||mmol/L||Standard Deviation|Mean
650879|NCT02042274|Primary|Blood Triglyceride|Blood triglycerides were measured at distinct time points: baseline, after 3 months supplementation, and after a 2 month wash out period.|Baseline, 3 months, 5 months|Healthy adults, ranging in age from 18-65 years.||mmol/L||Standard Deviation|Mean
650880|NCT02042131|Other Pre-specified|Number of Participants Who Were Admitted for Psychiatric Hospitalization Immediately Post-intervention by a Blinded Clinician|Doctoral-level clinicians (i.e., physicians or psychologists) who were blind to treatment condition made a determination regarding psychiatric inpatient admission (either admit or not admit) immediately following the intervention.|Immediately post-intervention|||Participants|||Count of Participants
650881|NCT02042131|Secondary|Inpatient Psychiatric Hospitalization Days|Mean number of days of inpatient psychiatric hospitalization|6 months|||days||Standard Error|Mean
650882|NCT02042131|Secondary|Beck Scale for Suicide Ideation (BSSI)|The BSSI is used to evaluate the intensity of the patient’s specific attitudes, behaviors, and plans to make a suicide attempt. BSSI total score was used as the outcome measure. Total scores range from 0 to 38, with higher scores indicating more severe suicide ideation.|1 month, 3 months, and 6 months|||units on a scale||Standard Error|Mean
650883|NCT02042131|Primary|Estimated Proportion of Participants With Suicide Attempt|Suicide attempts were assessed using the Suicide Attempt Self Injury Interview (SASII; Linehan et al., 2006). The SASII is a valid and reliable clinician-administered interview for categorizing suicide-related and self-injurious behaviors. Suicide attempt was defined as behavior that is self-directed and deliberately results in injury or the potential for injury to oneself for which there is evidence, whether implicit or explicit, of suicidal intent|6 months|all participants enrolled, regardless of dropout or withdrawal||estimated proportion of participants|||Number
650884|NCT02041533|Secondary|Disease-related Symptom Improvement Rate by Week 12|The Lung Cancer Symptom Score (LCSS) is a validated instrument designed to assess the impact of treatment on disease-related symptoms. It consists of 6 symptom-specific questions related to dyspnea, cough, fatigue, pain, hemoptysis and anorexia plus 3 summary items: symptom distress, interference with activity, and global HRQoL. The degree of impairment was recorded on a 100 mm visual analogue scale with scores from 0 to 100 with zero representing the best score. Disease-related symptom improvement rate by Week 12 is defined as the proportion of all randomized (all PD-L1+) participants who had 10 points or more decrease from baseline in average symptom burden index score at any time between randomization and Week 12.|From date of randomization to week 12|All randomized participants||Percentage of participants||95% Confidence Interval|Number
650899|NCT02041520|Primary|Change on Malondialdehyde After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients||The difference of this value at 6 months in relation to baseline value|||nM/mg protein||95% Confidence Interval|Mean
650900|NCT02041377|Secondary|Number of Subject Responses That Strongly Agree or Agree or Are Neutral With Questionnaire Statements|Staff obtained subject responses using short questionnaires to provide feedback on instructions for use and the basic operation of the BGMS. Subjects could respond Strongly Agree; Agree; Neutral; Disagree; or Strongly Disagree.|1 hour|||participants|||Number
650886|NCT02041533|Secondary|Duration of Response in Participants With PD-L1 Expression>= 5%|Duration of Response (DOR) was summarized for participants with objective response and was defined as the time between the date of first confirmed response (CR or PR) to the date of the first documented tumor progression as determined by IRRC assessment (per RECIST v1.1) or death due to any cause, whichever occurs first. DOR censoring rules were the same as the PFS primary definition. CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measureable disease and no new sites; Stable Disease (SD)= Failure to attain CR/PR or PD; Progressive Disease (PD)= Any new lesion or increase by >=50% of previously involved sites from nadir|From date of first confirmed response to date of tumor progression (Assessed up to August 2016, approximately 28 months)|All randomized participants with a confirmed response and PD-L1 expression >= 5%||months||Full Range|Median
650887|NCT02041533|Secondary|Objective Response Rate (ORR) in Participants With PD-L1 Expression >= 5%|ORR was defined as the proportion of randomized participants who achieved a Best Overall Response (BOR) of CR or PR using the RECIST v1.1 criteria per Independent Radiology Review Committee (IRRC) assessment. BOR was defined as the best response designation recorded between the date of randomization and the date of objectively documented progression or start of subsequent anti-cancer therapy, whichever occurred first. For participants without documented progression or subsequent therapy, all available response designations contributed to the BOR assessment. For participants who continued treatment beyond progression, BOR was determined from response designations recorded up to the time of initial progression. CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measureable disease and no new sites; Stable Disease (SD)= Failure to attain CR/PR or PD; Progressive Disease (PD)= Any new lesion or increase by >=50% of previously involved sites from nadir.|From date of randomization until date of documented tumor progression or subsequent anti-cancer therapy, whichever occurs first (assessed up to August 2016, approximately 28 months)|All randomized participants with PD-L1 expression >= 5%||Percentage of participants||95% Confidence Interval|Number
650888|NCT02041533|Secondary|Overall Survival in All Randomized Participants|Overall Survival (OS) was defined as the time from randomization to the date of death. A participant who had not died was censored at the last known alive date. OS was censored at the date of randomization for participants who were randomized but had no follow-up.|From date of randomization to date of death (assessed up to August 2016, approximately 28 months)|All randomized participants||months||95% Confidence Interval|Median
650889|NCT02041533|Secondary|Overall Survival in Participants With PD-L1 Expression >= 5%|Overall Survival (OS) was defined as the time from randomization to the date of death. A participant who had not died was censored at the last known alive date. OS was censored at the date of randomization for participants who were randomized but had no follow-up.|From date of randomization to date of death (assessed up to August 2016, approximately 28 months)|All randomized participants with PD-L1 expression >= 5%||months||95% Confidence Interval|Median
650890|NCT02041533|Secondary|Progression-Free Survival in All Randomized Participants|Progression-Free Survival (PFS) was defined as the time between the date of randomization and the first date of documented tumor progression, as determined by the Independent Radiology Review Committee (IRRC) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause, whichever occurs first. Participants who die without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who did not have any on-study tumor assessments and did not die were censored on the day they were randomized. Participants who received subsequent anti-cancer therapy prior to documented progression were censored at the last evaluable tumor assessment prior to the initiation of new therapy.|From date of randomization until date of documented tumor progression (assessed up to August 2016, approximately 28 months)|All randomized participants||months||95% Confidence Interval|Median
650891|NCT02041533|Primary|Progression-Free Survival in Participants With PD-L1 Expression >= 5%|Progression-Free Survival (PFS) was defined as the time between the date of randomization and the first date of documented tumor progression, as determined by the Independent Radiology Review Committee (IRRC) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause, whichever occurs first. Participants who die without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who did not have any on-study tumor assessments and did not die were censored on the day they were randomized. Participants who received subsequent anti-cancer therapy prior to documented progression were censored at the last evaluable tumor assessment prior to the initiation of new therapy.|From date of randomization until date of documented tumor progression (assessed up to August 2016, approximately 28 months)|All randomized participants with PD-L1 expression levels >= 5%||months||95% Confidence Interval|Median
650892|NCT02041520|Secondary|Change on Aspartate Aminotransferase After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients||The difference of this value at 6 months in relation to baseline value|||UI/L||95% Confidence Interval|Mean
650893|NCT02041520|Secondary|Change on Alanine Aminotransferase After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients||The difference of this value at 6 months in relation to baseline value|||UI/L||95% Confidence Interval|Mean
650894|NCT02041520|Secondary|Change on Reduced- Glutathion After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients||The difference of this value at 6 months in relation to baseline value|||µM||95% Confidence Interval|Mean
650895|NCT02041520|Secondary|Change on Oxidized- Glutathion After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients||The difference of this value at 6 months in relation to baseline value|||µM||95% Confidence Interval|Mean
650896|NCT02041520|Secondary|Change on Viral Load After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients||The difference of this value at 6 months in relation to baseline value|||copies/ml||95% Confidence Interval|Mean
650897|NCT02041520|Secondary|Change on Nitric Oxide After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients||The difference of this value at 6 months in relation to baseline value|||µM/ml||Standard Deviation|Mean
650898|NCT02041520|Secondary|Change on Total Glutathion After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients||The difference of this value at 6 months in relation to baseline value|||µM||95% Confidence Interval|Mean
650901|NCT02041377|Secondary|Number of Subject Fingerstick Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method When Obtained and Tested by Study Staff|Study staff obtained and tested subject fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma results were used to calculate the number of BGMS results within +/-15 mg/dL (<100 mg/dL YSI capillary plasma) and +/-15% (>=100 mg/dL YSI capillary plasma).|1 hour|133 (134-1) Blood glucose results were analyzed. Lab reference replicates for one subject were discrepant and not evaluable per protocol.||Blood glucose results|||Number
650902|NCT02041377|Secondary|Number of Blood Glucose (BG) Results From Alternative Site Testing (AST) Palm Blood Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method|Subjects with diabetes self-tested Alternative Site (AST) palm blood using an investigational Blood Glucose Monitoring System (BGMS) with no training. BGMS AST palm results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the number of BGMS results within +/-15 mg/dL (<100 mg/dL YSI capillary plasma) and +/-15% (>=100 mg/dL YSI capillary plasma).|1 hour|129 (134-5) Blood glucose results were analyzed. Lab reference replicates for one subject were discrepant and not evaluable per protocol. One subject had low blood sugar and AST result was not evaluable per protocol. One subject with low blood sugar did not attempt AST testing per protocol. No AST palm results were obtained for 2 subjects.||Blood glucose results|||Number
650903|NCT02041377|Secondary|Number of Venous Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method|Study staff tested subject venous blood using an investigational Blood Glucose Monitoring System (BGMS). Venous BGMS results were compared with subject venous plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer venous plasma BG results were used to calculate the number of BGMS results within +/-15 mg/dL (<100 mg/dL YSI venous plasma) and +/-15% (>=100 mg/dL YSI venous plasma).|1 hour|131 (134-3) Blood glucose results were analyzed. Lab reference replicates for one subject were discrepant and not evaluable per protocol. Venipuncture was not successful for 2 subjects.||Blood glucose results|||Number
650904|NCT02041377|Primary|Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method|Subjects with diabetes self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS) with no training. BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the number of BGMS results within +/-15 mg/dL (<100 mg/dL YSI capillary plasma) and +/-15% (>=100 mg/dL YSI capillary plasma).|1 hour|132 (134-2)Blood glucose results were analyzed. Lab reference replicates for one subject were discrepant and not evaluable per protocol. One subject had no fingerstick result.||Blood glucose results|||Number
650905|NCT02041325|Secondary|Phenotypic Changes|Phenotypic changes in peripheral blood cells following CC-5013 (lenalidomide) administration especially in regards to CD3, CD4, CD8 T cells, and NK and NKT cells.|6 weeks|||cells/cmm||Full Range|Median
650906|NCT02041325|Secondary|Quantity of Subjects With a T-cell Response|Participants who displayed a T cell responses against HbSAg following vaccination|6 weeks|||participants|||Number
650907|NCT02041325|Secondary|Safety|Number of participants with adverse events as a measure of safety and tolerability|6 weeks|||participants|||Number
650908|NCT02041325|Primary|Positive for Hepatitis B Surface Antigen|The number of participants who test positive for the antibody titer against hepatitis B surface antigen (HbSAg).|6 weeks|||participants|||Number
650909|NCT02041286|Secondary|Number of Subject Responses That Strongly Agree or Agree or Are Neutral With Questionnaire Statements|Staff will obtain subject responses using short questionnaires to provide feedback on instructions for use and the basic operation of the BGMS. Subjects may respond Strongly Agree; Agree; Neutral; Disagree; or Strongly Disagree.|1 hour|||participants|||Number
650910|NCT02041286|Secondary|Number of Subject Fingerstick Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method When Obtained and Tested by Study Staff|Study staff obtain and test subject fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results are compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma results are used to calculate the number of BGMS results within +/-15 mg/dL (<100 mg/dL YSI capillary plasma) and +/-15% (>=100 mg/dL YSI capillary plasma).|1 hour|135 (136-1) Blood glucose results were analyzed. One subject discontinued from all testing after hypoglycemia AE.||Blood glucose results|||Number
650911|NCT02041286|Secondary|Number of Blood Glucose (BG) Results From Alternative Site Testing (AST) Palm Blood Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method|Subjects with diabetes self-test Alternative Site (AST) palm blood using an investigational Blood Glucose Monitoring System (BGMS) with no training. BGMS AST palm results are compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results are used to calculate the number of BGMS results within +/-15 mg/dL (<100 mg/dL YSI capillary plasma) and +/-15% (>=100 mg/dL YSI capillary plasma).|1 hour|130 (136-6) Blood glucose results were analyzed. One subject discontinued from all testing after hypoglycemia AE. One (1) subject with low blood sugar did not attempt AST testing per protocol. No AST palm results were obtained for one (1) subject. Three (3) subjects had low blood sugar; AST results were not evaluable per protocol.||Blood glucose results|||Number
650912|NCT02041286|Secondary|Number of Venous Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method|Study staff test subject venous blood using an investigational Blood Glucose Monitoring System (BGMS). Venous BGMS results are compared with subject venous plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer venous plasma BG results are used to calculate the number of BGMS results within +/-15 mg/dL (<100 mg/dL YSI venous plasma) and +/-15% (>=100 mg/dL YSI venous plasma).|1 hour|132 (136-4) Blood glucose results were analyzed. One subject discontinued from all testing after hypoglycemia AE. One (1) subject lab reference replicates were discrepant and not evaluable per protocol. Venipuncture was not successful for 2 subjects.||Blood glucose results|||Number
655253|NCT01953328|Secondary|Percent Change From Baseline in the Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
650913|NCT02041286|Primary|Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method|Subjects with diabetes self-test fingerstick blood use an investigational Blood Glucose Monitoring System (BGMS) with no training. BGMS results are compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results are used to calculate the number of BGMS results within +/-15 mg/dL (<100 mg/dL YSI capillary plasma) and +/-15% (>=100 mg/dL YSI capillary plasma).|1 hour|135 (136-1) Blood glucose results were analyzed. One subject discontinued from testing after low BG fingerstick result (hypoglycemia AE), thus no reference result available.||Blood glucose results|||Number
650914|NCT02041221|Primary|Number of Subjects With Adverse Events|The no of adverse events will be assessed to evaluate the safety and tolerability of compound SO597 in healthy male subjects and asthma patients|Two (2) Weeks|||participants|||Number
650915|NCT02040792|Primary|Change From Baseline in Trough FEV1 (Forced Expiratory Volume in One Second)||Baseline to 28 days|||mL||Standard Error|Least Squares Mean
650916|NCT02040623|Primary|Change From Baseline (Visit 1) of Total Corneal Fluorescein Staining Score at 12 Weeks.|Change from baseline (Visit 1) of total CFS score at 12 weeks. Total CFS score range 0-20, where '0' represents no fluorescein staining of any region and '20' represents severe staining the entire cornea.|Baseline to 12 weeks|The per-protocol (PP) population excludes subjects with significant protocol deviations or with early study termination||units on a scale||Standard Deviation|Mean
650917|NCT02040532|Other Pre-specified|Quality of Life-Menopause Specific|"The Quality of life-Menopause specific is assessed by the Menopause Specific Quality of Life (MENQOL).
The MENQOL is self-administered and consists of a total of 29 items in a Likert-scale format. Each item assesses the impact of one of four domains of menopausal symptoms, as experienced over the last month: vasomotor (items 1–3), psychosocial (items 4–10), physical (items 11–26), and sexual (items 27–29). Items pertaining to a specific symptom are rated as present or not present, and if present, how bothersome on a zero (not bothersome) to six (extremely bothersome) scale. Means are computed for each subscale by dividing the sum of the domain’s items by the number of items within that domain. Non-endorsement of an item is scored a “1” and endorsement a “2,” plus the number of the particular rating, so that the possible score on any item ranges from 1-8. Total score also ranges from 1-8."|Baseline, study completion at 7 weeks|Analyzable population includes all 20 completers of the study, since all 20 completers of the study had MENQOL data at baseline and study completion.||scores on a scale||Full Range|Mean
650918|NCT02040532|Other Pre-specified|Quality of Life-Overall|Quality of life-Overall was assessed with the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q). The Q-LES-Q is a 16-item self-report questionnaire that assesses enjoyment of and satisfaction with life. The scoring of the Q-LES-Q-SF involves summing only the first 14 items to yield a raw total score. The last two items are not included in the total score but are standalone items. The raw total score ranges from 14 to 70 with higher scores indicating higher quality of life enjoyment and satisfaction.|Baseline, study completion at 7 weeks|Analyzable population includes all 20 completers of the study, since all 20 completers of the study had Q-LES-Q data at baseline and study completion.||scores on a scale||Full Range|Mean
650919|NCT02040532|Primary|Sleep Quality and Disturbances Over Past Month|"Sleep quality and disturbances during the past month were assessed with the Pittsburgh Sleep Quality Index (PSQI). The PSQI also incorporates daytime functioning into the total score.
In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality."|Baseline, study completion at 7 weeks|Analyzable population includes all 20 completers of the study, since all 20 completers of the study had PSQI data at baseline and study completion.||scores on a scale||Full Range|Mean
650920|NCT02040532|Primary|Severity of Insomnia|"Severity of insomnia was measured throughout the study using the Insomnia Severity Index (ISI) .The ISI is a 7-item scale that evaluates the severity of insomnia retrospectively over the past week. The scale is more specific to insomnia symptoms than the Pittsburgh scale (PSQI), which focuses more broadly on overall sleep quality.
The ISI score ranges from a minimum of 0 to 28. A score of 0-7=no clinically significant insomnia, 8-14=subthreshold insomnia, 5-21=clinical insomnia (moderate severity), 22-28=clinical insomnia (severe), with higher values indicating more severe insomnia."|Baseline, study completion at 7 weeks|Analyzable population includes all 20 completers of the study, since all 20 completers of the study had ISI data at baseline and study completion.||scores on a scale||Full Range|Mean
650921|NCT02040532|Primary|Vasomotor Symptoms (VMS) Frequency, Severity, and Bothersomeness During Nighttime|Vasomotor symptoms (VMS) were tracked and quantified prospectively using a daily hot flash diary. The hot flash diary was adapted from a 7-day self-report tool for vasomotor symptoms originally developed by the North Central Cancer Treatment Group (NCCTG). The diary asks for the subject to log number of hot flashes during the day and night, severity of hot flashes during day and night, and how bothersome the hot flashes were during day and night. Vasomotor symptoms were also systematically assessed at baseline, week 4, and week 7 using the Hot Flash-Related Daily Interference Scale (HFRDIS), a 10-item self-report questionnaire to determine perceived hot flash interference with quality of life and daily activities.|Baseline, study completion at 7 weeks|Though 20 participants completed the study, the analyzable population includes only the 19 completers who have VMS data for both baseline and the final visit.||vasomotor symptoms (VMS) per night||Full Range|Mean
650922|NCT02040532|Primary|Vasomotor Symptoms (VMS) Frequency, Severity, and Bothersomeness During Daytime|Vasomotor symptoms (VMS) were tracked and quantified prospectively using a daily hot flash diary. The hot flash diary was adapted from a 7-day self-report tool for vasomotor symptoms originally developed by the North Central Cancer Treatment Group (NCCTG). The diary asks for the subject to log number of hot flashes during the day and night, severity of hot flashes during day and night, and how bothersome the hot flashes were during day and night. Vasomotor symptoms were also systematically assessed at baseline, week 4, and week 7 using the Hot Flash-Related Daily Interference Scale (HFRDIS), a 10-item self-report questionnaire to determine perceived hot flash interference with quality of life and daily activities.|Baseline, study completion at 7 weeks|Though 20 participants completed the study, the analyzable population includes only the 19 completers who have VMS data for both baseline and the final visit.||vasomotor symptoms (VMS) per day||Full Range|Mean
655254|NCT01953328|Secondary|Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
650924|NCT02040532|Primary|Tolerability of Gabapentin|Tolerability of gabapentin was assessed by self-report at the week 1, week 4 and week 7 contacts by asking participants to complete the SAFTEE-SI and CPFQ questionnaires and prompting subjects to report any adverse events at each study visit. Tolerability of gabapentin is defined as the proportion of participants that is able to increase the dose from 300-mg to 600-mg and to remain on the higher dose for the duration of the trial.|Baseline, Week 4 visit, and study completion at 7 weeks|All 26 participants who initiated treatment with gabapentin were included in this analysis.||Participants|||Count of Participants
650925|NCT02040428|Secondary|Number of Participants With Re-bleeding at the Target Bleeding Site (TBS) Requiring Additional Treatment|The number of subjects who, after the initial establishment of TBS hemostasis at 3 minutes, had intra-operative re-bleeding requiring treatment at the TBS|Intra-operative, prior initiation of final chest wall closure.|||Participants|||Number
650926|NCT02040428|Secondary|Number of Participants With Hemostasis at the Target Bleeding Site (TBS) at 10 Minutes Following Treatment Application|The number of subjects achieving hemostatic success at 10 minutes following treatment application, with no re-bleeding at the TBS any time prior to the initiation of final chest wall closure.|Intraoperative, 10 minutes following treatment application|||Participants|||Number
650927|NCT02040428|Secondary|Number of Participants With Hemostasis at the Target Bleeding Site (TBS) at 6 Minutes Following Treatment Application|The number of subjects achieving hemostatic success at 6 minutes following treatment application with no re-bleeding at the TBS any time prior to the initiation of final chest wall closure.|Intraoperative, 6 minutes following treatment application|The secondary endpoint analyses were based on the Intent to Treat (ITT) analysis set.||Participants|||Number
650928|NCT02040428|Primary|Number of Participants With Hemostasis at the Target Bleeding Site (TBS) at 3 Minutes Following Treatment Application.|Number of subjects achieving hemostasis at the Target Bleeding Site (TBS) at 3 minutes following treatment application, with no re-bleeding at the TBS any time prior to the initiation of final chest wall closure|Intraoperative, 3 minutes following treatment application|The primary endpoint analysis was based on the Intent to Treat (ITT) analysis set, consisting of all randomized subjects.||Participants|||Number
650929|NCT02040116|Primary|Grade of Infusion Related Reactions With Rapid Infusion Will be Reported|Patients are given therapy on day 1 and if infusion is tolerated with < grade 2 reaction based on the CTCAE v4 then then will proceed to rapid infusion on day 14 which is given over 90 minutes. The grade of infusion reaction is measured for all patients and in all infusions given. According to the National Cancer Institute, there are 5 grades of IRR. In general, grade 1 reactions are classified as asymptomatic or only mild symptoms that do not require intervention. Grade 2 reactions are classified as moderate with minimal, local, or noninvasive interventions required. Grade 3 reactions are classified as severe and medically significant, but not immediately life-threatening. These reactions require hospitalization or prolongation of a current hospitalization. Grade 4 reactions are classified as life-threatening with urgent interventions required. Grade 5 reactions are classified as death related to an adverse drug event.|14 Days|Due to their being no reactions, the Grade of reactions for Standard infusion will and can not be reported, as the lowest grade requires there to be a reaction.|||||
650930|NCT02040116|Secondary|Change in Chair Time With Rapid Infusion Will be Reported|The amount of time spent administering the rituximab will be compared to the time from the first infusion to the second infusion. The change was calculated from two time points as the value at the later time point minus the value at the earlier time point.|14 Days|||Hours||Full Range|Mean
650931|NCT02040116|Primary|Incidence of Infusion Related Reactions With Rapid Infusion Will be Reported|Patients are given therapy on day 1 and if infusion is tolerated with < grade 2 reaction based on the CTCAE v4 then then will proceed to rapid infusion on day 14 which is given over 90 minutes. The number of infusion reaction is measured for all patients and in all infusions given.|14 Days|||infusion reactions|||Number
650932|NCT02040077|Secondary|Percent Participants Who Would Recommend the Intervention to a Family Member or Friend.|Participant willingness (yes or no) to recommend the intervention to a family member or friend.|Immediately after the intervention|||Participants|||Count of Participants
650933|NCT02040077|Primary|Knowledge Gain|"The primary outcome is based on performance in the randomized, controlled trial and is change from baseline on a knowledge test that is administered immediately before and after the intervention.
At the time of the study, no validated scales to assess general information regarding overdose in a true/false manner were available. Therefore the study developed a scale for the purpose of measuring knowledge increase. The scale included 51 items, rated as true, false, or I don't know (to discourage random guessing from resulting in accurate responses accidentally). The answers to all items were included as part of the intervention content so it was possible for every answer to be learned. The scale was summed together as a single measure of number correct responses (range 0-51) with no subscales. Higher values indicated more correct responses."|Before the intervention (pre-test) and immediately after the intervention (post-test)|||units on a scale||Standard Deviation|Mean
650934|NCT02039817|Primary|Cmax|Maximum concentration (Cmax)|48 hours|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
650935|NCT02039817|Secondary|Levels of cCK18|Biomarker cCK18 (Cleaved cytokeratin 18) PK evaluations from pre-dose to 48 hours|48 hours|||U/L||Inter-Quartile Range|Median
650936|NCT02039817|Primary|AUC|Area under the plasma concentration curve (AUC) parameters include AUC0-12, AUCinf, AUClast|48 hours|7 subjects were used in the calculation of AUC0-inf for the healthy volunteer group as one subject had no identifiable terminal log-linear phase.||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
650937|NCT02039778|Secondary|Quality of Life|The impact of ScRT on health-related quality of life (HRQOL) as assessed by EORTC Quality of Life Questionnaire (EORTC QLQ-C30)/Brain Cancer Module (BCM 20), Functional Assessment of Cancer Therapy with Brain Subscale (FACT-BR), and Activities of Daily Living Scale (ADLS) during ScRT.|36 months|no data available due to no subject completed the study. data not collected|||||
650938|NCT02039778|Secondary|Neurocognition|The potential neurocognitive effects of ScRT by the Hopkins Verbal Learning Test (HVLT), Mini-mental status exam (MMSE), Trail Making Tests A/B (TMT), and Controlled Word Association Test (COWAT).|36 month|no data available due to no subject completed the study. data not collected|||||
650939|NCT02039778|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|The short-and long-term toxicity of ScRT (and compare to historical controls).|36 months|||Participants|||Count of Participants
650943|NCT02039687|Secondary|Change in the Scores of the SFNSL, BPI, NPSI, and FAS Questionnaires|"Change in mean score from baseline to Day 28 is recorded for each outcome. Brief Pain Inventory (BPI), Pain Severity - scale of 0 (no pain) to 10 (worst pain imaginable) in 4 time frames, averaged.
BPI, Pain Interference - scale of 0 (does not interfere) to 10 (completely interferes) how pain interferes with 7 lifestyle parameters, averaged.
Small Fiber Neuropathy Screening List (SFNSL) - scale of 0 to 84 (higher score indicates greater neuropathy), sum of 21 questions.
Neuropathic Pain Symptom Inventory (NPSI) - scale of 0 (least pain) to 10 (most pain) in 10 questions, summed. Total score range from 0 to 100.
Fatigue Assessment Scale (FAS) - scale of 1 (never) to 5 (always) in 10 questions related to fatigue, summed. Total score range from 0 to 50, with 0 being the best possible score and 50 the worst.."|Baseline to 28 days|Questionnaires incomplete for some subjects||units on a scale||Standard Deviation|Mean
650944|NCT02039687|Secondary|Change in Intra-epidermal Nerve Fiber Density (IENFD)|Measurement of small fiber density in skin biopsies. Density is reduced in sarcoidosis patients, an indication of neuropathy.|Baseline and 28 days|||fibers/mm||Standard Deviation|Mean
650945|NCT02039687|Secondary|Change in the 6 Minute Walk Test|Measurement of the distance a patient can walk in 6 minutes|Baseline and 28 days|||meters||Standard Deviation|Mean
650946|NCT02039687|Primary|Change in Corneal Nerve Fiber Area|Measurement of corneal nerve fiber area is a non-invasive procedure performed at baseline and at the end of dosing and at 12 weeks follow-up. The nerve fiber area in sarcoidosis patients is reduced compared to normal humans, a measurement of small fiber loss.|Baseline and 28 days|||µm^2||Standard Deviation|Mean
650947|NCT02039427|Other Pre-specified|Potential Side Effects Associated With the Study Drugs|Potential side effects associated with the study drugs, such as anlgesic use, nausea and vomiting.|at 1, 6 and 24 hours after extubation|||Participants|||Count of Participants
650948|NCT02039427|Secondary|The Incidence of Postoperative Hoarseness(PH) Using Ketorolac and Dexamethasone in Womend After Thyroidectomy|"The investigator asked scales to patients at 1, 6 and 24h after extubation. PH was assessed using a 4-grade scale (0–3): 0, none; 1, mild (noticed by the patient only); 2, severe (obvious to observer); 3 aphonia (silence of voice)
● Incidence of hoarseness: If patient exhibit hoarseness scale more than 1, investigator will record as positive sign"|at 1, 6 and 24 hours after thyroidectomy|||Participants|||Count of Participants
650949|NCT02039427|Primary|The Incidence of Postoperative Sore Throat(POST) Using Ketorolac and Dexamethasone in Womend After Thyroidectomy|"The investigator asked scales to patients at 1, 6 and 24h after extubation. POST was defined as discomfort at larynx or pharynx at rest and during swallowing after surgery and was assessed using a 4-grade scale (0–3) based on verbal responses to questions: 0, none; 1, mild (less severe than with a cold); 2, moderate (similar with a cold); 3 severe (more severe than with a cold)
● Incidence of sore throat : if patient rates sore throat scale more than 1, investigator will record as positive symptom."|at 1, 6 and 24 hours after thyroidectomy|||Participants|||Count of Participants
650950|NCT02039414|Secondary|Maternal Lipid Oxidation|The investigators will measure maternal lipid oxidation rate using indirect calorimetry (True One 2400, Parvo Medics, Sandy, UT) before, during, and after acute exercise. This will involve placing a hoodlike device over the subject's head as they lay supine (rest).During exercise, this involved using a mouthpiece and noseclips. Using both techniques, The investigators will be able to calculate lipid oxidation rates from the volumes of CO2 produced and volumes of O2 used.The reported measure is lipid oxidation rate during exercise. The equation used to calculate lipid oxidation is: lipid oxidation (g/min) = 1.695 VO2- 1.701 VCO2 .|Visit 2 (32-37 weeks gestation)- reported lipid oxidation is the average of lipid oxidation over the course of the 30min exercise bout (i.e. data collected at minutes 8-10, minutes 18-20, and minutes 28-30 of exercise, all averaged together).|Of the 40 women consented, only 32 (16 per group) completed all study visits and have lipid oxidation data.||g/min||Standard Deviation|Mean
650951|NCT02039414|Secondary|Maternal Inflammation|High-Sensitivity C-reactive protein was measured.|This was taken while fasted and under resting conditions at the beginning of visit 2 (between 32 and 37 weeks gestation). This value was only measured at baseline (i.e. one timepoint).|Of the 40 women consented, only 32 (16 in each group, completed the study visits). Thus, these 32 have CRP data.||mg/L||Standard Deviation|Mean
650952|NCT02039414|Primary|Neonatal Insulin Resistance|Infant HOMA-IR will be determined by measuring umbilical cord plasma glucose and insulin concentrations at parturition vis cord blood collection. Cord blood will be collected within 30 min of delivery, centrifuged for 10 min at 3000rpm to remove plasma, and stored at -80.|Immediately after delivery|We could not obtain cord blood on all infants (thus, specimens were obtained fro 14 obese active and 12 obese inactive women). Due to medical emergencies or lack-of cord blood available, there were several instances where these specimens could not be obtained by the study team.||HOMA_IR, unitless measure||Standard Deviation|Mean
650953|NCT02039414|Primary|Neonatal Adiposity|Within 48 hours of delivery, neonatal body composition (% fat mass) will be measured by skin fold thickness measurement and by air displacement plethysmography (Pea Pod, Life Measurement, Inc., Concord, CA) in the CRU at WUSM.|24-48 hr after delivery|Several babies were not able to be measured for this part of the study- the primary reason being a weekend delivery that was discharged before measurements could be obtained by the study team. Our clinical research unit was not open on weekends to the the Peapod scans. This explains why there were only 15 babies per group for this outcome.||% fat||Standard Deviation|Mean
650954|NCT02039115|Primary|Stricture Formation|Primary outcome measure is the rate of symptomatic esophageal stricture formation.|98 weeks|||Participants|||Count of Participants
650955|NCT02038959|Secondary|Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part 4|Parkinson disease clinical characteristics will be assessed by a physician independent rater, blinded to treatment group, at baseline and at the conclusion of the study, using the Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS). Part IV concerns motor complications. The scale ranges from 0 to 24 with higher numbers indicated more severe disease.|baseline to one year|Data was not collected in 6 participants from the usual care arm and 9 participants from the virtual visits arm.||units on a scale||Standard Error|Mean
650978|NCT02038907|Secondary|Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: Cross-Protection Assay: GII.2 EC50 (HBGA)|"Blocking titers 50 (BT50) of anti-norovirus Cross-Protection Assay: GII.2 EC50 antibody titers as measured by HBGA binding assay. Data was collected for selected arms only.
D=Day"|Day 1 (Baseline) and Day 56|Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. Data was only collected for 2 of the arms.||titer||Standard Deviation|Geometric Mean
650956|NCT02038959|Secondary|Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part 3|Parkinson disease clinical characteristics will be assessed by a physician independent rater, blinded to treatment group, at baseline and at the conclusion of the study, using the Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS). Part III is retained as the motor examination. The scale ranges from 0 to 108 with higher numbers indicated more severe disease.|baseline to one year|Data was not collected in 9 participants from the usual care arm and 9 participants from the virtual visits arm.||units on a scale||Standard Error|Mean
650957|NCT02038959|Secondary|Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part 2|Parkinson disease clinical characteristics will be assessed by a physician independent rater, blinded to treatment group, at baseline and at the conclusion of the study, using the Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS). Part II concerns motor experiences of daily living. The scale ranges from 0 to 52 with higher numbers indicated more severe disease.|baseline to one year|Data was not collected in 12 participants from the usual care arm and 7 participants from the virtual visits arm.||units on a scale||Standard Error|Mean
650958|NCT02038959|Secondary|Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part IB|Parkinson disease clinical characteristics will be assessed by a physician independent rater, blinded to treatment group, at baseline and at the conclusion of the study, using the Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS). Part I concerns nonmotor experiences of daily living. The scale ranges from 0 to 52 with higher numbers indicated more severe disease.|baseline to one year|Data was not collected in 11 participants from the usual care arm and 7 participants from the virtual visits arm.||units on a scale||Standard Error|Mean
650959|NCT02038959|Secondary|Minutes Spend on Last Parkinson's Disease Provider Visit||One year|Data was not collected on 10 participants in the usual care arm and 28 participants in the virtual visits arm.||minutes||Inter-Quartile Range|Median
650960|NCT02038959|Secondary|Change in Patient Assessment of Chronic Illness Care|We will assess change in the perceived quality of care using the Patient Assessment of Chronic Illness Care (PACIC). Each scale is scored by averaging the items completed within that scale, and the overall PACIC is scored by averaging scores across all 20 items. The scale ranges from 1-5 with higher scores indicating better care by the health team.|baseline to one year|Data was not collected in 16 participants from the usual care arm and 12 participants from the virtual visits arm.||units on a scale||Standard Error|Mean
650961|NCT02038959|Secondary|Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part IA|Parkinson disease clinical characteristics will be assessed by a physician independent rater, blinded to treatment group, at baseline and at the conclusion of the study, using the Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS). Part I concerns nonmotor experiences of daily living. The scale ranges from 0 to 24 with higher numbers indicated more severe disease.|baseline to one year|Data was not collected in 6 participants from the usual care arm and 8 participants from the virtual visits arm.||units on a scale||Standard Error|Mean
650962|NCT02038959|Secondary|Change in Montreal Cognition Assessment|We will assess changes in cognition from baseline to the end of the study using the Montreal Cognitive Assessment (MoCA), administered remotely. The scale ranges from 0-30 with higher numbers indicating better cognition.|baseline to one year|Data was not collected on 6 participants in the usual care arm and 9 participants in the virtual visits arm.||units on a scale||Standard Error|Mean
650963|NCT02038959|Secondary|Change in EQ-5D Index Value|EuroQol five dimensions questionnaire (EQ-5D) is a standardized instrument for measuring generic health status. Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scale ranges from 11111 to 55555 with higher numbers indicating worse health status. The five-digit descriptors are converted to EQ-5D Index Values, which range from -0.109 (corresponding to 55555, the worst possible health) to 1.000 (corresponding to 11111, the best possible health).|baseline to one year|Data was not collected in 6 participants from the usual care arm and 9 participants from the virtual visits arm.||units on a scale||Standard Error|Mean
650964|NCT02038959|Primary|Change From Baseline in the Quality of Life Measured by Parkinson Disease Questionnaire 39|Assessed as the change in quality of life, measured by the Parkinson Disease Questionnaire 39 (PDQ-39). The PDQ-39 is a 39-item self-report questionnaire, which assesses Parkinson’s disease-specific health related quality over the last month. Assesses how often patients experience difficulties across the 8 quality of life dimensions. Assesses impact of Parkinson’s Disease (PD) on specific dimensions of functioning and well-being. The score ranges from 0-100 with lower scores reflecting better quality of life.|Baseline to One year|Data was not collected on 17 participants in the usual care arm and 18 participants in the virtual visits arm.||units on a scale||Standard Error|Mean
650965|NCT02038959|Primary|Feasibility of Virtual Visits for Parkinson Disease|Feasibility of virtual visits will be determined by the number of participants who complete at least one virtual visit successfully.|One year|||participants|||Number
650966|NCT02038933|Secondary|Objective Response Rate (ORR) Per Investigator Assessment|"ORR is defined as the number of subjects with a BOR of CR or PR, according to investigator assessment, divided by the number of treated subjects.
CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measureable disease and no new sites; Stable Disease (SD)= Failure to attain CR/PR or PD; Progressive Disease (PD)= Any new lesion or increase by >=50% of previously involved sites from nadir."|From first dose until date of documented disease progression or subsequent therapy, whichever occurs first (assessed up to April 2016, approximately 25 months)|All treated participants||Percentage of participants||95% Confidence Interval|Number
650967|NCT02038933|Secondary|Progression Free Survival|PFS is defined as the time from first dosing date to the date of the first documented progression, as determined by an IRRC according to the 2007 revised IWG Criteria for Malignant Lymphoma, or death due to any cause, whichever occurs first.|From date of first dose to date of documented disease progression or death due to any cause, whichever occurs first (assessed up to April 2016, approximately 25 months)|All treated participants||months||95% Confidence Interval|Median
650979|NCT02038907|Secondary|Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)|"Blocking Titers 50 (BT50) of anti-norovirus GII.4 Sydney antibody titers as measured by HBGA binding assay.
D=Day"|Day 1 (Baseline) and Days 28, 56, 208 and 393|"Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. n in the category is the number of participants with data available at the given time-point."||titer||Standard Deviation|Geometric Mean
650968|NCT02038933|Secondary|Duration of Partial Remission|"Duration of PR is defined as the time from first documentation of PR to the date of initial objectively documented progression as determined using the 2007 IWG criteria, based on IRRC assessment, or death due to any cause, whichever occurs first.
CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measureable disease and no new sites; Stable Disease (SD)= Failure to attain CR/PR or PD; Progressive Disease (PD)= Any new lesion or increase by >=50% of previously involved sites from nadir."|From date of first documentation of PR to date of disease progression or death due to any cause, whichever occurs first (assessed up to April 2016, approximately 25 months)|All participants with BOR of PR||months||Full Range|Median
650969|NCT02038933|Secondary|Rate of Partial Remission|"PR rate is defined as the number of subjects with a BOR of PR according to the 2007 revised IWG Criteria for Malignant Lymphoma, based on IRRC assessment, divided by the number of treated subjects.
CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measureable disease and no new sites; Stable Disease (SD)= Failure to attain CR/PR or PD; Progressive Disease (PD)= Any new lesion or increase by >=50% of previously involved sites from nadir."|From date of first dose to date of documentation of PR (assessed up to April 2016, approximately 25 months)|All treated participants||Percent of participants with BOR of PR||95% Confidence Interval|Number
650970|NCT02038933|Secondary|Duration of Complete Remission|"The duration of CR is defined as the time from first documentation of CR (the date of first negative FDG-PET scan or the date of first documentation of no disease involvement in the bone marrow [if required], whichever occurs later) to the date of initial objectively documented progression as determined using the 2007 IWG criteria, based on IRRC assessment, or death due to any cause, whichever occurs first.
CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measureable disease and no new sites; Stable Disease (SD)= Failure to attain CR/PR or PD; Progressive Disease (PD)= Any new lesion or increase by >=50% of previously involved sites from nadir."|From time of first documentation of CR to the date of initial documented disease progression or death due to any cause, whichever occurs first (Assessed up to April 2016, approximately 25 months)|All participants with BOR of CR||months||Full Range|Median
650971|NCT02038933|Secondary|Complete Remission Rate|Complete Remission Rate is defined as the number of subjects with a BOR of CR according to the 2007 revised IWG Criteria for Malignant Lymphoma, based on IRRC assessment, divided by the number of treated subjects. CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measureable disease and no new sites; SD= Failure to attain CR/PR or PD; PD= Any new lesion or increase by >=50% of previously involved sites from nadir.|From date of first dose to date of documented CR|All treated participants||Percent of participants with BOR of CR||95% Confidence Interval|Number
650972|NCT02038933|Secondary|Duration of Response (DOR)|DOR is defined as the time from first response (CR or PR) to the date of initial objectively documented progression as determined using the 2007 revised IWG Criteria for Malignant Lymphoma, based on IRRC assessment, or death due to any cause, whichever occurs first. CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measureable disease and no new sites; SD= Failure to attain CR/PR or PD; PD= Any new lesion or increase by >=50% of previously involved sites from nadir.|From date of first response to the date of documented disease progression or death, whichever occurs first (assessed up to April 2016, approximately 25 months)|All participants with BOR of CR or PR||months||95% Confidence Interval|Median
650973|NCT02038933|Primary|Objective Response Rate (ORR) Per Independent Radiologic Review Committee (IRRC) Assessment|ORR is defined as the number of subjects with a Best Overall Response (BOR) of Complete Remission (CR) or Partial Remission (PR), according to the 2007 revised International Working Group (IWG) Criteria for Malignant Lymphoma, , based on IRRC assessment, divided by the number of treated subjects. CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measureable disease and no new sites; Stable Disease (SD)= Failure to attain CR/PR or PD; Progressive Disease (PD)= Any new lesion or increase by >=50% of previously involved sites from nadir.|From first dose until date of documented disease progression or subsequent therapy, whichever occurs first (assessed up to April 2016, approximately 25 months)|All treated participants||Percentage of participants||95% Confidence Interval|Number
650974|NCT02038907|Secondary|Percentage of Participants With Any Adverse Event (AE) Leading to Withdrawal From the Study|Withdrawal due to an AE will occur if the participant experiences an AE that requires early termination because continued participation imposes an unacceptable risk to the participant's health or the participants is unwilling to continue because of the AE.|Day 1 up to Day 56|Safety Analysis Set included all participants who received at least one dose of trial vaccine.||percentage of participants|||Number
650975|NCT02038907|Secondary|Percentage of Participants With Significant New Medical Conditions|"Significant new medical conditions will be evaluated by the investigator for the co-existence of any of the following conditions: Adverse events of special interest (AESIs) are predefined events for potential immune mediated disorders. All AESIs are medically evaluated to assess if they might indicate an immune-mediated disorder.
Immune mediated events (IMEs) are AEs that represent a new diagnosis of a chronic medical condition that was not present or suspected prior to enrollment."|Day 1 up to Day 56|Safety Analysis Set included all participants who received at least one dose of trial vaccine.||percentage of participants|||Number
650976|NCT02038907|Secondary|Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: Cross-Protection Assay: GII.4.2012 EC50 (HBGA)|"Blocking titers 50 (BT50) of anti-norovirus Cross-Protection Assay: GII.4.2012 EC50 antibody titers as measured by HBGA binding assay. Data was collected for selected arms only.
D=Day"|Day 1 (Baseline) and Day 56|Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. Data was only collected for 2 of the arms.||titer||Standard Deviation|Geometric Mean
650977|NCT02038907|Secondary|Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: Cross-Protection Assay: GI.3 EC50 (HBGA)|"Blocking titers 50 (BT50) of anti-norovirus Cross-Protection Assay: GI.3 EC50 antibody titers as measured by HBGA binding assay. Data was collected for selected arms only.
D=Day"|Day 1 (Baseline) and Day 56|Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. Data was only collected for 2 of the arms.||titer||Standard Deviation|Geometric Mean
651038|NCT02038075|Secondary|Beck Depression Inventory, Second Edition (BDI-II)|The BDI-II is a 21-item self-report instrument developed to measure severity of depression in adults and adolescents. Each of the items consists of four statements reflecting increasing levels of severity for a particular symptom of depression.|24 months||||||
650980|NCT02038907|Secondary|Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)|"Blocking titers 50 (BT50) of anti-norovirus GII.4 Cincinnati antibody titers as measured by HBGA binding assay.
D=Day"|Day 1 (Baseline) and Days 28, 56, 208 and 393|"Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. n in the category is the number of participants with data available at the given time-point."||titer||Standard Deviation|Geometric Mean
650981|NCT02038907|Secondary|GMFR of Antibody Titers of Strains Not Represented in the Investigational Vaccine: Cross-Protection Assays|"GMFR of anti-norovirus Cross-Protection Assays: GII.2 EC50, GI.3 EC50 and GII.4.2012 EC50 antibody titers as measured by HBGA binding assay. Data was collected for selected arms only.
D=Day"|Day 56|Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. Data was only collected for 2 of the arms.||titer||Standard Deviation|Geometric Mean
650982|NCT02038907|Secondary|GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)|"GMFR of anti-norovirus GII.4 Sydney antibody titers as measured by HBGA binding assay.
D=Day"|Days 28, 56, 208 and 393|"Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. n in the category is the number of participants with data available at the given time-point."||titer||Standard Deviation|Geometric Mean
650983|NCT02038907|Secondary|GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)|"GMFR of anti-norovirus GII.4 Cincinnati antibody titers as measured by HBGA binding assay.
D=Day"|Days 28, 56, 208 and 393|"Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. n in the category is the number of participants with data available at the given time-point."||titer||Standard Deviation|Geometric Mean
650984|NCT02038907|Secondary|Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)|"Geometric mean fold rise (GMFR) of anti-norovirus GII.4 VLP antibody titers as measured by the HBGA binding assay.
D=Day"|Days 28, 56, 208 and 393|"Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. n in the category is the number of participants with data available at the given time-point."||titer||Standard Deviation|Geometric Mean
650985|NCT02038907|Secondary|Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)|"Geometric mean fold rise (GMFR) of anti-norovirus GI.1 VLP antibody titers as measured by HBGA binding assay.
D=Day"|Days 28, 56, 208 and 393|"Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. n in the category is the number of participants with data available at the given time-point."||titer||Standard Deviation|Geometric Mean
650986|NCT02038907|Secondary|Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)|"Blocking titers 50 (BT50) of anti-norovirus GII.4 VLP antibody titers as measured by HBGA binding assay.
D=Day"|Day 1 (Baseline) and Days 28, 56, 208 and 393|"Full Analysis Set included all participants who received at least one dose of trial vaccine. n in the category is the number of participants with data available at the given time-point."||titer||Standard Deviation|Geometric Mean
650987|NCT02038907|Secondary|Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)|"Blocking titers 50 (BT50) of anti-norovirus GI.1 VLP antibody titers as measured by HBGA binding assay.
D=Day"|Baseline (Day 1) and Days 28, 56, 208 and 393|"Full Analysis Set included all participants who received at least one dose of trial vaccine. n in the category is the number of participants with data available at the given time-point."||titer||Standard Deviation|Geometric Mean
650988|NCT02038907|Secondary|Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)|"The percentage of participants with a 4-fold rise or greater in serum anti-norovirus antibody titers for GII.4 virus-like particle (VLP) as measured by HBGA binding assay.
D=Day"|Baseline and Days 28, 56, 208 and 393|"Per-Protocol Set included all participants who received both doses of study drug and who had no major protocol violations. n in the category is the number of participants with data available at the given time-point."||percentage of participants||95% Confidence Interval|Number
650989|NCT02038907|Secondary|Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)|"The percentage of participants with a 4-fold rise or greater in serum anti-norovirus antibody titers for GI.1 virus-like particle (VLP) as measured by HBGA binding assay.
D=Day"|Baseline and Days 28, 56, 208 and 393|"Per-Protocol Set included all participants who received both doses of study drug and who had no major protocol violations. n in the category is the number of participants with data available at the given time-point."||percentage of participants||95% Confidence Interval|Number
650990|NCT02038907|Secondary|Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA)|"Percentage of participants with a 4-fold rise or greater in serum anti-norovirus antibody titers for both GI.1 VLP and GII.4 VLP as measured by histoblood group antigen (HBGA) binding assay.
D=Day"|Baseline and Days 28, 56, 208 and 393|"Full Analysis Set included all randomized participants who received at least one dose of trial vaccine. n in the category is the number of participants with data available at the given time-point."||percentage of participants||95% Confidence Interval|Number
650991|NCT02038907|Secondary|Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)|"Geometric mean fold rise (GMFR) of anti-norovirus GII.4 VLP antibody titers as measured by IgA ELISA for all arms on day 28 and day 56 and for selected arms on day 208 and day 393.
D=Day"|Days 28, 56, 208 and 393|"Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. n in the category is the number of participants with data available at the given time-point."||ratio||Standard Deviation|Geometric Mean
650992|NCT02038907|Secondary|Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)|"Geometric mean fold rise (GMFR) of anti-norovirus GI.1 VLP antibody titers as measured by IgA ELISA for all arms on day 28 and day 56 and for selected arms on day 208 and day 393.
D=Day"|Days 28, 56, 208 and 393|"Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. n in the category is the number of participants with data available at the given time-point."||ratio||Standard Deviation|Geometric Mean
651021|NCT02038790|Secondary|Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Burning or Stinging?|Participant responses were captured on a 10-point scale with 0 = None and 9= Extreme.|Days 0-1|The per-protocol population included participants who did not miss any visit and had no major protocol violations.||percentage of participants|||Number
650993|NCT02038907|Secondary|Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)|"Geometric mean titer (GMT) of anti-norovirus GII.4 VLP antibody titers as measured by IgA ELISA for all arms on day 28 and day 56 and for selected arms on day 208 and day 393.
D=Day"|Day 1 (Baseline) and Days 28, 56, 208 and 393|"Full Analysis Set included all randomized participants who received at least one dose of trial vaccine. n in the category is the number of participants with data available at the given time-point."||titer||Standard Deviation|Geometric Mean
650994|NCT02038907|Secondary|Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)|"Geometric mean titer (GMT) of anti-norovirus GI.1 VLP antibody titers as measured by IgA ELISA for all arms on day 28 and day 56 and for selected arms on day 208 and day 393.
D=Day"|Day 1 (Baseline) and Days 28, 56, 208 and 393|"Full Analysis Set included all randomized participants who received at least one dose of trial vaccine. n in the category is the number of participants with data available at the given time-point."||titer||Standard Deviation|Geometric Mean
650995|NCT02038907|Secondary|Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)|"The percentage of participants with a 4-fold rise from or greater in serum anti-norovirus antibody titers for GII.4 virus-like particle (VLP) as measured by immunoglobulin A (IgA) enzyme-linked immunosorbent assay (ELISA) for all arms on day 28 and day 56 and for selected arms on day 208 and day 393.
D=Day"|Baseline and Days 28, 56, 208 and 393|"Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. n in the category is the number of participants with data available at the given time-point."||percentage of participants||95% Confidence Interval|Number
650996|NCT02038907|Secondary|Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)|"The percentage of participants with a 4-fold rise or greater in serum anti-norovirus antibody titers for GI.1 virus-like particle (VLP) as measured by immunoglobulin A (IgA) enzyme-linked immunosorbent assay (ELISA) for all arms on day 28 and day 56 and for selected arms on day 208 and day 393.
D=Day"|Baseline and Days 28, 56, 208 and 393|"Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. n in the category is the number of participants with data available at the given time-point."||percentage of participants||95% Confidence Interval|Number
650997|NCT02038907|Secondary|Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)|"Percentage of participants with a 4-fold rise or greater in serum anti-norovirus antibody titers for both GI.1 VLP and GII.4 VLP as measured by immunoglobulin A (IgA) enzyme-linked immunosorbent assay (ELISA) for all arms on day 28 and day 56 and for selected arms on day 208 and day 393.
D=Day"|Baseline and Days 28, 56, 208 and 393|"Full Analysis Set included all randomized participants who received at least one dose of trial vaccine. n in the category is the number of participants with data available at the given time-point."||percentage of participants||95% Confidence Interval|Number
650998|NCT02038907|Secondary|Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)|"Geometric mean fold rise (GMFR) of anti-norovirus GII.4 VLP antibody titers as measured by pan-Ig ELISA.
D=Day"|Days 28, 56, 208 and 393|"Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. n in the category is the number of participants with data available at the given time-point."||ratio||Standard Deviation|Geometric Mean
650999|NCT02038907|Secondary|Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)|"Geometric mean fold rise (GMFR) of anti-norovirus GI.1 VLP antibody titers as measured by pan-Ig ELISA.
D=Day"|Days 28, 56, 208 and 393|"Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. n in the category is the number of participants with data available at the given time-point."||ratio||Standard Deviation|Geometric Mean
651000|NCT02038907|Secondary|Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)|"Geometric mean titer (GMT) of anti-norovirus GII.4 VLP antibody titers as measured by pan-Ig ELISA.
D=Day"|Day 1 (Baseline) and Days 28, 56, 208 and 393|"Full Analysis Set included all randomized participants who received at least one dose of trial vaccine. n in the category is the number of participants with data available at the given time-point."||titer||Standard Deviation|Geometric Mean
651001|NCT02038907|Secondary|Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)|"Geometric mean titer (GMT) of anti-norovirus GI.1 VLP antibody titers as measured by pan-Ig ELISA.
D=Day"|Day 1 (Baseline) and Days 28, 56, 208 and 393|"Full Analysis Set included all randomized participants who received at least one dose of trial vaccine. n in the category is the number of participants with data available at the given time-point."||titer||Standard Deviation|Geometric Mean
651002|NCT02038907|Secondary|Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA)|"The percentage of participants with a 4-fold rise or greater from in serum anti-norovirus antibody titers for GII.4 virus-like particle (VLP) as measured by pan immunoglobulin (Pan-Ig) enzyme-linked immunosorbent assay (ELISA).
D=Day"|Baseline and Days 28, 56, 208 and 393|"Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. n in the category is the number of participants with data available at the given time-point."||percentage of participants||95% Confidence Interval|Number
651003|NCT02038907|Secondary|Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)|"The percentage of participants with a 4-fold rise or greater in serum anti-norovirus antibody titers for GI.1 virus-like particle (VLP) as measured by pan immunoglobulin (Pan-Ig) enzyme-linked immunosorbent assay (ELISA).
D=Day"|Baseline and Days 28, 56, 208 and 393|"Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. n in the category is the number of participants with data available at the given time-point."||percentage of participants||95% Confidence Interval|Number
651004|NCT02038907|Secondary|Percentage of Participants With a Seroresponse on Day 28, Day 208 and Day 393 (Pan-Ig ELISA)|"Seroresponse was defined as 4-fold rise or greater in serum anti-norovirus antibody titers for both GI.1 virus-Like particle (VLP) and GII.4 VLP as measured by pan immunoglobulin (Pan-Ig) enzyme-linked immunosorbent assay (ELISA).
D=Day"|Baseline and Days 28, 208 and 393|"Full Analysis Set included all randomized participants who received at least one dose of trial vaccine. n in the category is the number of participants with data available at the given time-point."||percentage of participants||95% Confidence Interval|Number
651067|NCT02037347|Secondary|Time-to-mucosal Re-epithelialization||The number of days between the start of palifermin administration and complete re-epithelialization of oral mucosa up to 14 days|Adverse event experienced by participant precluded measuring this outcome.|||||
651005|NCT02038907|Primary|Percentage of Participants With Serious Adverse Events (SAEs)|A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.|Day 1 up to Day 393|Safety population included all participants who received at least one dose of trial vaccine.||percentage of participants|||Number
651006|NCT02038907|Primary|Percentage of Participants With Unsolicited Adverse Events (AEs)|Unsolicited AEs are any AEs that are not solicited local or systemic AEs, as defined by this study.|Day 1 up to Day 56|Safety population included all participants who received at least one dose of trial vaccine.||percentage of participants|||Number
651007|NCT02038907|Primary|Oral Body Temperature Within 7 Days After Dose 2|Oral body temperature measurement is to be performed using the thermometer provided by the site for 7 days after each vaccination. The highest body temperature observed each day will be recorded on the Diary Card also provided by the site.|Days 28 through 34|Safety population included all participants who received at least one dose of trial vaccine.||degrees Celsius||Standard Deviation|Mean
651008|NCT02038907|Primary|Oral Body Temperature Within 7 Days After Dose 1|Oral body temperature measurement is to be performed using the thermometer provided by the site for 7 days after each vaccination. The highest body temperature observed each day will be recorded on the Diary Card also provided by the site.|Days 1 through 7|Safety population included all participants who received at least one dose of trial vaccine.||degrees Celsius||Standard Deviation|Mean
651009|NCT02038907|Primary|Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2|Solicited systemic AEs are defined as: headache, fatigue, myalgia, arthralgia, vomiting, and diarrhea that occurred within 7 days after each vaccination.|Days 28 through 34|Safety population included all participants who received at least one dose of trial vaccine.||percentage of participants|||Number
651010|NCT02038907|Primary|Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1|Solicited systemic AEs are defined as: headache, fatigue, myalgia, arthralgia, vomiting, and diarrhea that occurred within 7 days after each vaccination.|Days 1 through 7|Safety population included all participants who received at least one dose of trial vaccine.||percentage of participants|||Number
651011|NCT02038907|Primary|Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2|Solicited local AEs at injection site are defined as: pain, erythema, induration, and swelling that occurred within 7 days after each vaccination.|Days 28 through 34|Safety population included all participants who received at least one dose of trial vaccine.||percentage of participants|||Number
651012|NCT02038907|Primary|Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1|Solicited local AEs at injection site are defined as: pain, erythema, induration, and swelling that occurred within 7 days after each vaccination.|Days 1 through 7|Safety population included all participants who received at least one dose of trial vaccine.||percentage of participants|||Number
651013|NCT02038907|Primary|Percentage of Participants With a Seroresponse (Pan-Ig ELISA)|Seroresponse was defined as 4-fold rise or greater in serum anti-norovirus antibody titers for both GI.1 virus-Like particle (VLP) and GII.4 VLP as measured by pan immunoglobulin (Pan-Ig) enzyme-linked immunosorbent assay (ELISA).|Baseline and Day 56|Full Analysis Set included all randomized participants who received at least one dose of trial vaccine.||percentage of participants||95% Confidence Interval|Number
651014|NCT02038790|Secondary|Change From Baseline in Subject Opiate Withdrawal Scale (SOWS)|"Participants completed the Subject Opiate Withdrawal Scale (SOWS) at baseline, and the end of each day of treatment.
SOWS is a validated scale when used as defined. The research site did not use SOWS as defined. The sponsor made the decision to not report this data since it was not captured in a validated format."|Day 0 prior to dosing, end of Day 0 (post dose), end of Day 1 (post dose)|Per protocol set.|||||
651015|NCT02038790|Secondary|Dissolution Time of Intervention as Recorded by a Trained Observer|The subject was observed and times documented for time of administration and time dissolution (recorded in minutes and seconds) was completed by designated qualified study personnel at the site.|Days 0-1|The per-protocol population included participants who did not miss any visit and had no major protocol violations.||minutes||Standard Deviation|Mean
651016|NCT02038790|Secondary|Percentage of Participant Response to the Question: Compared to the Medication That You Are Currently Using for Treatment of Opioid Dependence, The Study Medication You Just Used Was.....|"Choices to the question above are:
More effective as a treatment for opioid dependence
Equally effective as a treatment for opioid dependence
Less effective as a treatment for opioid dependence
The same medication that I normally use"|Days 0-1|The per-protocol population included participants who did not miss any visit and had no major protocol violations.||percentage of participants|||Number
651017|NCT02038790|Secondary|Percentage of Participant Response to the Question: If You Did Want to Abuse This Medication, Would You Prefer to......|"Choices to the question above are:
Crush and snort
Liquefy and inject
Not able to abuse this formulation"|Days 0-1|The per-protocol population included participants who did not miss any visit and had no major protocol violations.||percentage of participants|||Number
651018|NCT02038790|Secondary|Percentage of Participant Response to the Request: When Thinking About the Medication You Used Today, Indicate on the Line Below Your Ability to Abuse This Medication|Participant responses were captured on a 10-point scale with 0 = No desire to abuse and 9= Extremely high desire to abuse.|Days 0-1|The per-protocol population included participants who did not miss any visit and had no major protocol violations.||percentage of participants|||Number
651019|NCT02038790|Secondary|Percentage of Participant Response to the Request: Please Rate the Medication You Received Today in Terms of the Drug's Ability to Product a 'High'|Participant responses were captured on a 10-point scale with 0 = No high and 9= Extremely strong high.|Days 0-1|The per-protocol population included participants who did not miss any visit and had no major protocol violations.||percentage of participants|||Number
651020|NCT02038790|Secondary|Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Skin Irritation or Blisters?|Participant responses were captured on a 10-point scale with 0 = None and 9= Extreme.|Days 0-1|The per-protocol population included participants who did not miss any visit and had no major protocol violations.||percentage of participants|||Number
655255|NCT01953328|Secondary|Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
651022|NCT02038790|Secondary|Percentage of Participant Favorable and Unfavorable Response to the Question: How Easily Did the Medication Dissolve in Your Mouth?|Responses were captured on a 5-point scale with the 5 representing the most favorable response, 3 representing a neutral response and 1 representing a negative response. 'Favorable' responses include assessments 5 and 4, while 'Unfavorable' responses include assessments 3, 2 and 1.|Days 0-1|The per-protocol population included participants who did not miss any visit and had no major protocol violations.||percentage of participants|||Number
651023|NCT02038790|Secondary|Percentage of Participant Favorable and Unfavorable Response to the Question: How Comfortable Did It Feel In Your Mouth?|Responses were captured on a 5-point scale with the 5 representing the most favorable response, 3 representing a neutral response and 1 representing a negative response. 'Favorable' responses include assessments 5 and 4, while 'Unfavorable' responses include assessments 3, 2 and 1.|Days 0-1|The per-protocol population included participants who did not miss any visit and had no major protocol violations.||percentage of participants|||Number
651024|NCT02038790|Secondary|Percentage of Participant Favorable and Unfavorable Response to the Question: How Easy or Difficult Were the Package Instructions to Follow?|Responses were captured on a 5-point scale with the 5 representing the most favorable response, 3 representing a neutral response and 1 representing a negative response. 'Favorable' responses include assessments 5 and 4, while 'Unfavorable' responses include assessments 3, 2 and 1.|Days 0-1|The per-protocol population included participants who did not miss any visit and had no major protocol violations.||percentage of participants|||Number
651025|NCT02038790|Secondary|Percentage of Participant Favorable and Unfavorable Response to the Question: How Easy or Difficult Was it to Open the Package?|Responses were captured on a 5-point scale with the 5 representing the most favorable response, 3 representing a neutral response and 1 representing a negative response. 'Favorable' responses include assessments 5 and 4, while 'Unfavorable' responses include assessments 3, 2 and 1.|Days 0-1|The per-protocol population included participants who did not miss any visit and had no major protocol violations.||percentage of participants|||Number
651026|NCT02038790|Secondary|Participant Assessments With Regard to Ease of Dissolution of Interventions|At the conclusion of Study Day 1, participants completed a study exit product comparison questionnaire. This outcome summarizes the percentage of participant answers to the question: Which one did you think dissolve easier in your mouth?|Day 1|The per-protocol population included participants who did not miss any visit and had no major protocol violations.||percentage of participants|||Number
651027|NCT02038790|Secondary|Participant Preference With Regard to Overall Taste of Interventions|At the conclusion of Study Day 1, participants completed a study exit product comparison questionnaire. This outcome summarizes the percentage of participant answers to the question: Which one did you prefer in regards to overall taste?|Day 1|The per-protocol population included participants who did not miss any visit and had no major protocol violations.||percentage of participants|||Number
651028|NCT02038790|Primary|Overall Intervention Preference As Assessed by Participants|At the conclusion of Study Day 1, participants completed a study exit product comparison questionnaire. This outcome summarizes the percentage of participant answers to the question: When thinking about the two medications you evaluated over the last two days, which medication type did you prefer?|Day 1|The per-protocol population included participants who did not miss any visit and had no major protocol violations.||percentage of participants|||Number
651029|NCT02038543|Secondary|Mean Percent Conversion of Hydroxyproline (Hyp) to Urinary Glycolate (UGIc)|The overall contribution of Hyp catabolism to urinary oxalate (UOx) and glycolate (UGlc) excretion is determined by the excess mole percent enrichment of urine with 13C2-oxalate and glycolate corrected for the fraction of labelled [15N,13C5]-Hyp that is circulating in the plasma.|Participants will be followed for the duration of the study infusion and observations, an average of 24 hours|2 subjects from the PH Type Non 1,2,3 withdrew from the study. Subjects with PH Type Non 1,2,3 were not included in the analysis as only 1 subject completed the study.||percent converted||Standard Error|Mean
651030|NCT02038543|Primary|Mean Percent Conversion of Hydroxyproline (Hyp) to Urinary Oxalate (UOx)|The overall contribution of hydroxyproline catabolism to urinary oxalate (UOx) and glycolate (UGlc) excretion is determined by the excess mole percent enrichment of urine with 13C2-oxalate and glycolate corrected for the fraction of labelled [15N,13C5]-Hyp that is circulating in the plasma.|Participants will be followed for the duration of study infusion and observation, an average of 24 hours.|2 subjects from the PH Type Non 1,2,3 withdrew from the study. Subjects with PH Type Non 1,2,3 were not included in the analysis as only 1 subject completed the study.||percent converted||Standard Error|Mean
651031|NCT02038075|Other Pre-specified|Post Treatment Health Interview (PTHI)|Frequency, intensity, and location of each patient’s accessing of medical services will be assessed via medical record review.|24 months||||||
651032|NCT02038075|Other Pre-specified|Suicide Cognitions Scale (SCS)|The SCS-R is an 18-item self-report measure that measures two aspects of suicide-specific hopelessness: 1) unlovability (which measures more trait-like aspects of hopelessness), and 2) unbearability (which measures more state-like aspects of hopelessness).|24 months||||||
651033|NCT02038075|Other Pre-specified|Interpersonal Needs Questionnaire (INQ)|The INQ is a 10-item self-report questionnaire that measures current beliefs about the extent to which the respondent feels connected to others (i.e., thwarted belongingness), and the extent to which he or she feels like a burden on the people in their lives (i.e., perceived burdensomeness).|24 months||||||
651034|NCT02038075|Other Pre-specified|Suicide Intent Scale|The SIS is a 15-item, interviewer-administered assessment of the intensity of an individual’s intent to die at the time of a suicide attempt. It assesses verbal and nonverbal indicators of suicidal attempt including objective circumstances surrounding the attempt, and the attempters’ perceptions of the attempt.|24 months||||||
651035|NCT02038075|Other Pre-specified|Structured Clinical Interview for DSM-IV, Axis I and II (SCID)|The SCID (patient version with psychotic screen) is a diagnostic instrument based on DSM-IV diagnostic criteria for Axis I disorders.|Intake||||||
651036|NCT02038075|Secondary|Beck Anxiety Inventory|The BAI is a 21-item scale that measures the severity of anxiety in adults and adolescents.|24 months||||||
651037|NCT02038075|Secondary|Beck Hopelessness Scale (BHS)|The BHS consists of 20 true-false statements designed to assess the extent of positive and negative beliefs about the future.|24 months||||||
651068|NCT02037347|Primary|Time-to-cutaneous Re-epithelialization||The number of days between the start of palifermin administration and complete re-epithelialization of skin up to 14 days|||days|||Number
651039|NCT02038075|Secondary|Scale for Suicide Ideation (SSI)|The SSI is a 21-item, interviewer-administered scale used to evaluate the current intensity of the patient’s specific attitudes, behaviors, and plans to commit suicide. The SSI has moderately high internal consistency and good concurrent and discriminant validity for psychiatric outpatients. Inter-rater reliability has been found to be higher than .98, with good evidence of predictive validity.|24 months||||||
651040|NCT02038075|Primary|Estimated Percentage of Participants Making Suicide Attempt During 24-month Follow-up|The SASII is a clinician-administered interview designed to assess the factors involved in nonfatal suicide attempts and intentional self-injury. The SASII assesses variables related to method, reliability, lethality, impulsivity, likelihood of rescue, suicidal intent, consequences, and habitual self-injury. Interrater reliabilities for each item range from .87-.98, with the correlation for rater classification of behavior (i.e., suicide attempt or non-suicidal self-injury) being .92. The SASII demonstrates very high agreement in identifying and classifying suicide-related events when compared to clinician therapy notes, patient diary cards, and medical records (for events requiring medical attention).|24 months|intent to treat||estimated percentage w/ suicide attempt|||Number
651041|NCT02037776|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale (HAD)|"The HAD is a 14-item scale with 2 subscales of depression (Question 1, 3, 5, 7, 9, 11, and 13) and anxiety (Question 2, 4, 6, 8, 10, 12, and 14). Each item on the questionnaire is scored from 0 to 3 (ranging from 0 to 21, lower value represents a better outcome).
The point scores of HAD are calculated from changes from baseline in overall (sum of scores for depression and anxiety, i.e., total point score ranging from 0 to 42, lower value represents a better outcome), depression, and anxiety at final evaluation."|Baseline and week 8|||score||Standard Deviation|Mean
651042|NCT02037776|Secondary|Change From Baseline in Short-form Health Survey-8 (SF-8)|"The SF-8 scores comprised of Physical component summary (PCS) scores (ranging between 5.32-70.69, higher value represents a better outcome) and Mental component summary (MCS) scores (ranging between 10.11-74.51, higher value represents a better outcome), and a total scores of PCS and MCS using a formula specified in SF-8 Scoring Algorithm.
The point scores of SF-8 are calculated from changes from baseline in PCS and MCS at final evaluation."|Baseline and week 8|||units on a scale||Standard Deviation|Mean
651043|NCT02037776|Secondary|Change From Baseline in Global Overall Symptom (GOS)|The GOS scale are calculated by a total score of a 7-point Likert scale ranging from 1 = no problem to 7 = a very severe problem over 8 questions. The point scores of GOS are calculated from changes from baseline at final evaluation.|Baseline and Week 8|||units on a scale||Standard Deviation|Mean
651044|NCT02037776|Secondary|Change From Baseline in the Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM)|"PAGI-SYM questionnaire is composed of the following 6 categories that consisted of Questions 1 to 20 (each question composed of 6 subscales, i.e., point scores from 0 to 5, lower value represents a better outcome). Subscale scores are calculated by averaging across items in each category. A total score (lower value represents a better outcome, ranging from 0 to 5) is calculated as the mean of the subscale scores.
Heartburn/Regurgitation, Nausea/Vomiting, Postprandial Fullness/Early satiety, Bloating, Upper Abdominal Pain, and Lower Abdominal Pain
The point scores of PAGI-SYM are calculated from changes from baseline in total score and each category score at final evaluation."|Baseline and Week 8|||units on a scale||Standard Deviation|Mean
651045|NCT02037776|Secondary|Change From Baseline in Modified Frequency Scale for the Symptoms of Gastroesophageal Reflux Disease (GERD) (Modified FSSG)|"The modified FSSG questionnaire is composed of 7 questions regarding GERD symptoms (Questions 1-7, scored from 0 to 4) ranging between 0-28, lower value represents a better outcome, and 7 questions regarding dyspeptic symptoms (Questions 8-14, each question scored from 0 to 4) ranging between 0-28, lower value represents a better outcome, and a total scores, ranging from 0 to 56, lower value represents a better outcome of the all questions (Questions 1-14). Each question was assigned a score based on the frequency of symptoms.
The point scores of modified FSSG are calculated from changes from baseline in each score for all symptoms (sum of point scores from Questions 1-14), GERD symptoms, and dyspeptic symptoms at final evaluation."|Baseline and Week 8|||units on a scale||Standard Deviation|Mean
651046|NCT02037776|Primary|Patient's Evaluation of Symptomatic Improvement by Overall Treatment Efficacy (OTE)|"Patient's Evaluation of Symptomatic Improvement by OTE is classified into the following 7 categories:
Significantly improved
Improved
Slightly improved
No change
Slightly worse
Worse
Much worse
The numbers of patients at the final evaluation (i.e, the latest evaluable time point of the all patients including discontinued patients) are shown by category."|8 weeks|||Participants|||Count of Participants
651048|NCT02037477|Secondary|Number of Participants With Markedly Abnormal Laboratory Values|The number of participants with markedly abnormal laboratory values for Chemistry, Hematology and Urinalysis during the study is reported.|At Screening, baseline (Day -3), administration period (Day 1, Day 8), and post-test (Day 28)|Safety analysis set - All participants who received at least 1 dose of study drug.||participants|||Number
651049|NCT02037477|Secondary|Number of Participants With Abnormal 12-lead Electrocardiogram (at Rest) Findings||At Screening, baseline (Day -3), administration period (Day 8), and post-test (Day 28)|Safety analysis set - All participants who received at least 1 dose of study drug.||participants|||Number
651050|NCT02037477|Secondary|Number of Participants With Abnormal Changes From Baseline in Vital Signs|Vital signs included body temperature (oral or tympanic measurement), sitting blood pressure (after the participant has rested for at least 5 minutes), and pulse (bpm).|At screening, baseline (Day -3, Day -2, Day -1), administration period (Days 1, Day 2, Day 7, Day 8), and post-test (Day 28)|Safety analysis set - All participants who received at least 1 dose of study drug.||participants|||Number
651051|NCT02037477|Secondary|Frequency of Adverse Events|The frequency of adverse events by type, seriousness, time to onset. Adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug to the last dose of study drug.|31 days|Safety analysis set - All participants who received at least 1 dose of study drug.||participants|||Number
651069|NCT02036840|Primary|Number of Subjects With Antibiotic Related Adverse Event||24 hours|||participants|||Number
651786|NCT02020369|Secondary|Number of Administrations of Study Drug Per Mild/Moderate Bleeding Episode||Within 24 hours of Bleeding Episode|Treated Population with non-missing measurements||Number of Administrations of Study Drug|Bleeding episodes|Standard Deviation|Mean
651052|NCT02037477|Primary|Intragastric pH Time Course Over 24 Hours|Intragastric pH was measured continuously for 24 hours (hr) by pH monitor. pH holding time ratio (HTR) is the percentage of time a pH is maintained at a particular level. For example, pH 4 HTR is the percentage of time the pH = 4.|At baseline (Day -2 to Day -1), administration period (Days 1 to Day 2 and Days 7 to Day 8)|Pharmacodynamic (PD) Analysis Set - Participants receiving study medication who completed protocol procedures without serious violation of the protocol were eligible for PD analysis. All 10 subjects from Cohort 1 were included. Three subjects in Cohort 2 were excluded from the PD analysis set, which therefore consisted of 7 subjects.||percentage of time||Standard Deviation|Mean
651053|NCT02037425|Other Pre-specified|Neuronal Regrowth|Compare neuronal regrowth in the skin biopsies with duration of benefit of onabotulinumtoxinA in Groups A, B, C from baseline to 12 weeks post randomization. Neuronal regrowth change was scored on a 0-3 point scale with 0 being no change from baseline in regrowth and 3 being significant change from baseline.|Baseline & Week 12 Post Randomization|Only a subset of subjects (n = 14) completed this endpoint for the trial based on the protocol design.||units on a scale||Standard Deviation|Mean
651054|NCT02037425|Secondary|Duration of onabotulinumtoxinA Over 3 Injection Cycles|Compare duration of benefit of onabotulinumtoxinA response through 3 injection cycles as measured by headache days per week (including the last 4 weeks of every injection cycle). A percent of responders was calculated using a 30% reduction of the number of headache days compared to average number of headache per week during baseline.|Weeks 9, 10, 11, 12, 21, 22, 23, 24, 33, 34, 35, 36 Post Randomization|||percentage of responders|||Number
651055|NCT02037425|Secondary|Consistency of Response to onbotulinumtoxinA Over Three Injection Cycles|Compare the consistency of duration of onabotulinumtoxinA response by the group assignment at 12 weeks to assessments at 24, and 36 weeks evaluations as measured by the number of responders. A responder is defined as a 30% reduction from baseline in the number of headache days.|Weeks 12, 24, and 36 Post Randomization|||participants|||Number
651056|NCT02037425|Secondary|Acute Medication Usage|Comparison of acute medication usage between Groups A, B, and C during baseline, Treatment Period 1, 2, and 3.|From day 1 (first day of baseline) to day 281 (84th day of injection cycle 3) plus or minus 12 days|||number of medications used||Standard Deviation|Mean
651057|NCT02037425|Secondary|Sleep Quality Question|Comparison between Group A, B, and C for sleep quality scores measured at baseline and weeks 12, 24, and 36 post-randomization. A single sleep quality question was asked indicating quality of sleep over the past four weeks. The scale ranged from 1-5, with 1 being very poor quality and 5 being very good quality of sleep.|Baseline, Week 12, Week 24, and Week 36 Post Randomization|||units on a scale||Standard Deviation|Mean
651058|NCT02037425|Secondary|State-Trait Anxiety Inventory (STAI)|Comparison between Group A, B, and C for STAI scores measured at baseline and weeks 12, 24, and 36. Scores range from 20-80, with 20 indicating lower levels of anxiety most generally, and 80 indicating higher levels of anxiety most generally.|Baseline, Week 12, Week 24, and Week 36 Post Randomization|||units on a scale||Standard Deviation|Mean
651059|NCT02037425|Secondary|Beck Depression Inventory II (BDI-II)|Comparison between Group A, B, and C for BDI-II scores measured at baseline and weeks 12, 24, and 36. A total score of 0-10 = these ups and downs are considered normal, 11-16 = mild mood disturbance,17-20 = borderline clinical depression, 21-30 = moderate depression, 31-40 = severe depression, over 40 = extreme depression|Baseline, Week 12, Week 24, and Week 36 Post Randomization|||units on a scale||Standard Deviation|Mean
651060|NCT02037425|Secondary|Physician Global Impression of Change (PGIC)|Comparison between Group A, B, and C for PGIC scores measured at weeks 12, 24, and 36. the PGIC scale scores range from 0-7 with 0 being Very Much Worse and 7 being Very Much Improved. A higher score indicates a greater impression of change.|Week 12, Week 24, and Week 36 Post Randomization|||units on a scale||Standard Deviation|Mean
651061|NCT02037425|Secondary|Social Readjustment Rating Scale (SRRS)|Comparison between Group A, B, and C for SRRS scores (impact of common stressors) measured at baseline and weeks 12, 24, and 36. Scores can range from 0 to an undetermined amount, as subjects are allowed to rate unlisted events according to their own sense of stress. A total lower than 150 suggests a low level of stress and a low probability of developing a stress-related disorder. Scores greater than 150 suggest higher levels of stress and higher probabilities of developing stress-related disorders.|Baseline, Week 12, Week 24, and Week 36 Post Randomization|||units on a scale||Standard Deviation|Mean
651062|NCT02037425|Secondary|Migraine Disability Assessment Scale (MIDAS)|"Comparison between Group A, B, and C for MIDAS total scores (effect migraine headaches have on subjects daily function) measured at baseline and weeks 12, 24, and 36.
Total score of disability ranges:
0 to 5, MIDAS Grade I, Little or no disability
6 to 10, MIDAS Grade II, Mild disability
11 to 20, MIDAS Grade III, Moderate disability
21+, MIDAS Grade IV, Severe disability Score ranges from 0-450. No subscales are present."|Baseline, Week 12, Week 24, and Week 36 Post Randomization|||units on a scale||Standard Deviation|Mean
651063|NCT02037425|Secondary|Headache Days|Comparison of headache days per month over each injection cycle between Groups A, B, and C (Baseline (28 days), Treatment Period 1(84 days), Treatment Period 2(84 days), and Treatment Period 3(84 days). Subjects will remain in their assigned groups based on assessment at 12 weeks.|From day 29 (first day of injection cycle 1) to day 281 (84th day of injection cycle 3) plus or minus 12 days|||number of headache days||Standard Deviation|Mean
651064|NCT02037425|Primary|Duration of onabotulinumtoxinA Over 3 Injection Cycles in Groups A, B, and C|Compare the duration of onabotulinumtoxinA response through the 3 injection cycles of the study for Groups A, B, and C as measured by headache days during each period (Baseline (28 days), Treatment Period 1(84 days), Treatment Period 2(84 days), and Treatment Period 3(84 days). Duration of response is defined as a 30% reduction in the number of headache days compared to baseline.|From day 29 (first day of injection cycle 1) to day 281 (84th day of injection cycle 3) plus or minus 12 days|||percentage of responders|||Number
651065|NCT02037425|Primary|Subject Global Impression of Change|Changes in the Subject's Global Impression of Change (SGIC) measured at weeks 12, 24, and 36 for Groups A, B, and C. Subject global impression of change was measured on a 7 point scale with 0 being Very Much Worse and 7 Very Much Improved.|Weeks 12, 24, and 36 Post Randomization|Subjects included in this outcome measure analysis include those completing treatment period 1 injection cycle and returning at visit 3.||units on a scale||Standard Deviation|Mean
651066|NCT02037347|Secondary|Time-to-cessation of Epidermal Necrosis||The number of days between the start of palifermin administration and cessation of further epidermal necrosis up to 14 days|||days|||Number
651070|NCT02036775|Secondary|Plateau Time During Which Concentration of the Analyte in Plasma Exceeds 75% of Cmax ss|Plateau time during which concentration of the analyte in plasma exceeds 75% of Cmax ss (T(C>75% Cmax ss))|Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg|PK-BA set||hours||Full Range|Median
651071|NCT02036775|Secondary|Time Period When Concentration of the Analyte Exceeds Cav ss|Time period when the concentration of the analyte exceeds Cav ss (T (C>Cav ss))|Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg|PK-BA set||hours||Full Range|Median
651072|NCT02036775|Secondary|Peak-trough Swing|Peak-trough swing (PTS) calculated as ((Cmax,ss - Cmin,ss / Cav,ss)*100)|Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg|PK-BA set||percentage of ng/mL||Standard Deviation|Mean
651073|NCT02036775|Secondary|Peak-trough Fluctuation Between Minimum and Maximum Concentration of the Analyte in Plasma|Peak-trough fluctuation between minimum and maximum concentration of the analyte in plasma (PTF)|Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg|PK-BA set||ng/mL||Standard Deviation|Mean
651074|NCT02036775|Secondary|Time From Dosing to the Maximum Concentration of the Analyte in Plasma at Steady State|Time from dosing to the maximum concentration of the analyte in plasma at steady state (tmax ss). For Lasolvan 30mg and Lasolvan 60mg, tmax ss was determined as tmax ss 0-12 and tmax ss 12-24.|Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg|PK-BA set||hours||Full Range|Median
651075|NCT02036775|Secondary|Average Concentration of the Analyte in Plasma in the Time Interval of 0 to 24 h at Steady State|Average concentration of the analyte in plasma in the time interval of 0 to 24 h at steady state (Cav ss)|Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg|PK-BA set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
651076|NCT02036775|Secondary|Steady State Concentration of the Analyte in Plasma at the End of Dosing Interval|Steady state concentration of the analyte in plasma at the end of dosing interval (Cmin ss)|Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
651077|NCT02036775|Secondary|Rate of Absorption at Steady State (Cmax ss/AUCss 0-24)|Metric which characterises the rate of absorption at steady state (Cmax ss/AUCss 0-24)|Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg|PK-BA set||1/h||Geometric Coefficient of Variation|Geometric Mean
651078|NCT02036775|Secondary|Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State During 0-24 h, Adjusted to a Daily Dose of 60 mg|Area under the concentration-time curve of the analyte in plasma at steady state during 0-24 h, adjusted to a daily dose of 60 mg (AUCss 0-24 norm)|Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg|PK-BA set||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
651079|NCT02036775|Primary|Maximum Measured Concentration of the Analyte in Plasma at Steady State|Maximum measured concentration of the analyte in plasma at steady state (Cmax ss)|Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg|PK-BA set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
651080|NCT02036775|Primary|Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to 24 h at Steady State|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 h at steady state (AUCss 0-24)|Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg|Pharmacokinetic (PK) set relative bioavailability set (PK-BA set) which includes all subjects in the treated set who completed 3 periods and for whom the PK profiles in 3 periods could be adequately characterized in respect to at least 1 of the PK parameters of primary interest without important protocol violations relevant to the evaluation of PK.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
651081|NCT02036580|Secondary|Immunogenecity|The incidence rate of positive serum antibodies to tralokinumab will be reported.|From baseline to Week 48|Safety population||Patients|||Number
651082|NCT02036580|Secondary|Serum Tralokinumab Concentration Data|Serum tralokinumab concentration data will be summarized by treatment group.|From baseline to Week 48 (Week 0 [post-dose, within +5 minutes after end of infusion], Week 4 [pre-dose], Week 12 [pre-dose]. Week 28, Week 40, Week 48)|PK population||Microgram per milliliter||Standard Deviation|Mean
651083|NCT02036580|Primary|Safety and Tolerability Primarily Assessed by the Number of Patients With Adverse Events|Adverse events and serious adverse events using the Safety Population. Other variables used for the safety assessments include electrocardiogram, vital signs, and routine laboratory assessments. These variables as well as their changes from baseline will be summarized descriptively.|From baseline to Week 48 (treatment-emergent only)|Safety population||Patients|||Number
651151|NCT02034591|Secondary|Adjusted Geometric Mean of the Maximum Observed Plasma Concentration (Cmax) of Apixaban|Maximum observed plasma concentration (Cmax) is measured in nanograms per milliliter (ng/mL)|Pre-dose and 0.25, 0.50, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, 72 hours post-dose for each intervention|All randomized participants with available PK data||ng/mL||90% Confidence Interval|Geometric Mean
651084|NCT02036541|Primary|Mean Change in IOP From Baseline|Mean change in IOP from baseline was calculated for subjects who completed the 12-month visit and the worst within-eye IOP was used for subjects who underwent a glaucoma-related secondary surgical intervention.|12 Months|All subjects who completed the 12-month visit or underwent a glaucoma-related secondary surgical procedure prior to the 12-month visit were evaluated in this analysis.||mmHg||Standard Deviation|Mean
651085|NCT02036541|Primary|Proportion of Subjects Achieving a 20% or Greater Reduction in IOP From Baseline on the Same or Less Number of Medications|Proportion of subjects achieving a 20% or greater reduction in IOP from baseline on the same or less number of medications. Subjects who underwent a glaucoma-related secondary surgical intervention prior to the 12-month visit were considered failures in this analysis.|12 Months|All subjects who completed the 12-month visit or underwent a glaucoma-related secondary surgical procedure prior to the 12-month visit were evaluated in this analysis.||Participants|||Count of Participants
651086|NCT02036515|Secondary|Change From Baseline in EQ-5D-3L Score at Week 52|"The EQ-5D-3L is a health profile questionnaire that assesses quality of life along 5 dimensions. Participants rate 5 aspects of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) by choosing from 3 answering options (1=no problems; 2=some problems; 3=extreme problems). The summed score ranges from 3-15 with 3 corresponding to no problems and 15 corresponding to severe problems in the 5 dimensions. EQ-5D-3L also includes an EQ VAS that ranges between 100 (best imaginable health) and 0 (worst imaginable health). Decrease from baseline in EQ-5D-3L signifies improvement. Total index EQ-5D-3L summary score is weighted with a range of -0.594 (worst) to 1.0 (best). Data presented exclude data following the initiation of rescue therapy."|Baseline and Week 52|Analysis population included all randomized participants who took at least one dose of study medication and had at least one EQ-5D-3L measurement (baseline or post-baseline).||Score on a scale||95% Confidence Interval|Least Squares Mean
651087|NCT02036515|Secondary|Change From Baseline in EQ-5D-3L Questionnaire Score at Week 26|"The EQ-5D-3L is a health profile questionnaire that assesses quality of life along 5 dimensions. Participants rate 5 aspects of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) by choosing from 3 answering options (1=no problems; 2=some problems; 3=extreme problems). The summed score ranges from 3-15 with 3 corresponding to no problems and 15 corresponding to severe problems in the 5 dimensions. EQ-5D-3L also includes an EQ VAS that ranges between 100 (best imaginable health) and 0 (worst imaginable health). Decrease from baseline in EQ-5D-3L signifies improvement. Total index EQ-5D-3L summary score is weighted with a range of -0.594 (worst) to 1.0 (best). Data presented exclude data following the initiation of rescue therapy."|Baseline and Week 26|Analysis population included all randomized participants who took at least one dose of study medication and had at least one EQ-5D-3L measurement (baseline or post-baseline).||Score on a scale||95% Confidence Interval|Least Squares Mean
651088|NCT02036515|Secondary|Baseline EQ-5D 3-level Version (EQ-5D-3L) Questionnaire Score|"The EQ-5D-3L is a health profile questionnaire that assesses quality of life along 5 dimensions. Participants rate 5 aspects of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) by choosing from 3 answering options (1=no problems; 2=some problems; 3=extreme problems). The summed score ranges from 1-15 with 3 corresponding to no problems and 15 corresponding to severe problems in the 5 dimensions. EQ-5D-3L also includes an EQ visual analogue score (VAS) that ranges between 100 (best imaginable health) and 0 (worst imaginable health). Total index EQ-5D-3L summary score is weighted with a range of -0.594 (worst) to 1.0 (best)."|Baseline|Analysis population included all randomized participants who took at least one dose of study medication and had a baseline EQ-5D-3L measurement.||Score on a scale||Standard Deviation|Mean
651089|NCT02036515|Secondary|Change From Baseline in HOMA-%β at Week 52|HOMA-%β is a well-accepted means of assessing fasting β-cell function, and is calculated using measured C-peptide and glucose levels and is measured as a percentage of a normal reference population. HOMA-%β = [20 x fasting insulin (μU/mL)] / [fasting plasma glucose (mmol/L) - 3.5]. Data presented exclude data following the initiation of rescue therapy.|Baseline and Week 52|Analysis population included all randomized participants who took at least one dose of study medication and had at least one HOMA-%β measurement (baseline or post-baseline).||Percentage||95% Confidence Interval|Least Squares Mean
651090|NCT02036515|Secondary|Change From Baseline in HOMA-%β at Week 26|HOMA-%β is a well-accepted means of assessing fasting β-cell function, and is calculated using measured C-peptide and glucose levels and is measured as a percentage of a normal reference population. HOMA-%β = [20 x fasting insulin (μU/mL)] / [fasting plasma glucose (mmol/L) - 3.5]. Data presented exclude data following the initiation of rescue therapy.|Baseline and Week 26|Analysis population included all randomized participants who took at least one dose of study medication and had at least one HOMA-%β measurement (baseline or post-baseline).||Percentage||95% Confidence Interval|Least Squares Mean
651091|NCT02036515|Secondary|Baseline Homeostasis Model Assessment of β-cell Function (HOMA-%β) Value|HOMA-%β is a well-accepted means of assessing fasting β-cell function, and is calculated using measured C-peptide and glucose levels and is measured as a percentage of a normal reference population. HOMA-%β = [20 x fasting insulin (μU/mL)] / [fasting plasma glucose (mmol/L) - 3.5]|Baseline|Analysis population included all randomized participants who took at least one dose of study medication and had HOMA-%β measurement at baseline.||Percentage||Standard Deviation|Mean
651092|NCT02036515|Secondary|Time to Initiation of Glycemic Rescue by Week 52|Glycemic rescue medication was initiated for participants who met progressively more stringent glycemic rescue criteria. Rescue medication included glimepiride (or insulin glargine if glimepiride was not considered appropriate for the participant). Data presented are the minimum and maximum times to the initiation of rescue therapy in days.|Up to week 52|Analysis population included all randomized participants who took at least one dose of trial treatment.||Days|||Number
651093|NCT02036515|Secondary|Time to Initiation of Glycemic Rescue by Week 26|Glycemic rescue medication was initiated for participants who met progressively more stringent glycemic rescue criteria. Rescue medication included glimepiride (or insulin glargine if glimepiride was not considered appropriate for the participant). Data presented are the minimum and maximum times to the initiation of rescue therapy in days. Below data include data from 1 participant in the Placebo arm who continued Phase A treatment for an additional 30 days.|Up to Week 26 (plus 30 days for 1 placebo participant)|Analysis population included all randomized participants who took at least one dose of trial treatment||Days|||Number
655256|NCT01953328|Secondary|Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
651094|NCT02036515|Secondary|Percentage of Participants Receiving Glycemic Rescue Medication by Week 52|Glycemic rescue medication was initiated for participants who met progressively more stringent glycemic rescue criteria. Rescue medication included glimepiride (or insulin glargine if glimepiride was not considered appropriate for the participant).|Week 52|Analysis population included all randomized participants who took at least one dose of trial treatment.||Percentage of participants|||Number
651095|NCT02036515|Secondary|Percentage of Participants Receiving Glycemic Rescue Medication by Week 26|Glycemic rescue medication was initiated for participants who met progressively more stringent glycemic rescue criteria. Rescue medication included glimepiride (or insulin glargine if glimepiride was not considered appropriate for the participant).|Week 26|Analysis population included all randomized participants who took at least one dose of trial treatment.||Percentage of participants|||Number
651096|NCT02036515|Secondary|Change From Baseline in Sitting Diastolic Blood Pressure at Week 52|The change from baseline is the Week 52 diastolic blood pressure minus the Week 0 diastolic blood pressure. Sitting blood pressure was measured in triplicate. Data presented exclude data following the initiation of rescue therapy.|Baseline and Week 52|Analysis population included all randomized participants who took at least one dose of study medication and had at least one diastolic blood pressure measurement (baseline or post-baseline).||mmHg||Standard Error|Least Squares Mean
651097|NCT02036515|Secondary|Change From Baseline in Sitting Diastolic Blood Pressure at Week 26|The change from baseline is the Week 26 diastolic blood pressure minus the Week 0 diastolic blood pressure. Sitting blood pressure was measured in triplicate. Data presented exclude data following the initiation of rescue therapy.|Baseline and Week 26|Analysis population included all randomized participants who took at least one dose of study medication and had at least one diastolic blood pressure measurement (baseline or post-baseline).||mmHg||Standard Error|Least Squares Mean
651098|NCT02036515|Secondary|Change From Baseline in Sitting Systolic Blood Pressure at Week 52|The change from baseline is the Week 52 systolic blood pressure minus the Week 0 systolic blood pressure. Sitting blood pressure was measured in triplicate. Data presented exclude data following the initiation of rescue therapy.|Baseline and Week 52|Analysis population included all randomized participants who took at least one dose of study medication and had at least one systolic blood pressure measurement (baseline or post-baseline).||mmHg||Standard Error|Least Squares Mean
651099|NCT02036515|Secondary|Percentage of Participants With an A1C <7% (53 mmol/Mol) at Week 52|A1C is measured as percent. Laboratory measurements were performed after an overnight fast ≥10 hours in duration. Data presented exclude data following the initiation of rescue therapy.|Week 52|Analysis population included all randomized participants who took at least one dose of study medication and had at least one A1C measurement (baseline or post-baseline).||Percentage of participants|||Number
651100|NCT02036515|Secondary|Change From Baseline in Body Weight at Week 52|The change from baseline is the Week 52 body weight minus the Week 0 body weight. Data presented exclude data following the initiation of rescue therapy.|Baseline and Week 52|Analysis population included all randomized participants who took at least one dose of study medication and had at least one body weight measurement (baseline or post-baseline).||kg||95% Confidence Interval|Least Squares Mean
651101|NCT02036515|Secondary|Change From Baseline in FPG at Week 52|The change from baseline is the Week 52 FPG minus the Week 0 FPG. Laboratory measurements were performed after an overnight fast ≥10 hours in duration. Data presented exclude data following the initiation of rescue therapy.|Baseline and Week 52|Analysis population included all randomized participants who took at least one dose of study medication and had at least one FPG measurement (baseline or post-baseline).||mg/dL||95% Confidence Interval|Least Squares Mean
651102|NCT02036515|Secondary|Change From Baseline in Hemoglobin A1C at Week 52|A1C is measured as percent. Thus this change from baseline reflects the Week 52 A1C percent minus the Week 0 A1C percent. Laboratory measurements were performed after an overnight fast ≥10 hours in duration. Data presented exclude data following the initiation of rescue therapy.|Baseline and Week 52|Analysis population included all randomized participants who took at least one dose of study medication and had at least one A1C measurement (baseline or post-baseline).||Percent||95% Confidence Interval|Least Squares Mean
651103|NCT02036515|Secondary|Change From Baseline in Sitting Systolic Blood Pressure at Week 26|The change from baseline is the Week 26 systolic blood pressure minus the Week 0 systolic blood pressure. Sitting blood pressure was measured in triplicate. Data presented exclude data following the initiation of rescue therapy.|Baseline and Week 26|Analysis population included all randomized participants who took at least one dose of study medication and had at least one systolic blood pressure measurement (baseline or post-baseline).||mmHg||Standard Error|Least Squares Mean
651104|NCT02036515|Secondary|Percentage of Participants With an A1C <7% (53 mmol/Mol) at Week 26|A1C is measured as percent. Laboratory measurements were performed after an overnight fast ≥10 hours in duration. Data presented exclude data following the initiation of rescue therapy.|Week 26|Analysis population included all randomized participants who took at least one dose of study medication and had at least one A1C measurement (baseline or post-baseline).||Percentage of participants|||Number
651105|NCT02036515|Secondary|Change From Baseline in Body Weight at Week 26|The change from baseline is the Week 26 body weight minus the Week 0 body weight. Data presented exclude data following the initiation of rescue therapy.|Baseline and Week 26|Analysis population included all randomized participants who took at least one dose of study medication and had at least one body weight measurement (baseline or post-baseline).||kg||95% Confidence Interval|Least Squares Mean
651106|NCT02036515|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26|The change from baseline is the Week 26 FPG minus the Week 0 FPG. Laboratory measurements were performed after an overnight fast ≥10 hours in duration. Data presented exclude data following the initiation of rescue therapy.|Baseline and Week 26|Analysis population included all randomized participants who took at least one dose of study medication and had at least one FPG measurement (baseline or post-baseline).||mg/dL||95% Confidence Interval|Least Squares Mean
651107|NCT02036515|Primary|Percentage of Participants Discontinuing Study Treatment Due to an AE|An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment. Data presented include data following the initiation of rescue therapy.|Up to Week 52|Analysis population consisted of all randomized participants who took at least one dose of study medication.||Percentage of participants|||Number
651108|NCT02036515|Primary|Percentage of Participants Experiencing An Adverse Event (AE)|An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment. Data presented include data following the initiation of rescue therapy.|Up to Week 54|Analysis population consisted of all randomized participants who took at least one dose of study medication.||Percentage of participants|||Number
651109|NCT02036515|Primary|Change From Baseline in Hemoglobin A1C at Week 26|A1C is measured as percent. Thus this change from baseline reflects the Week 26 A1C percent minus the Week 0 A1C percent. Laboratory measurements were performed after an overnight fast ≥10 hours in duration. Data presented exclude data following the initiation of rescue therapy.|Baseline and Week 26|Analysis population included all randomized participants who took at least one dose of study medication and had at least one A1C measurement (baseline or post-baseline).||Percent||95% Confidence Interval|Least Squares Mean
651110|NCT02036424|Primary|Change in Optical Coherence Tomography (OCT) Central Subfield Thickness (CST) From Baseline to Month Seven|Optical coherence tomography (OCT) is an established medical imaging technique that uses light to capture micrometer-resolution, three-dimensional images. The image is presented in grid form which divides that retina into sections. The center most section (CST) is used for this outcome measurement.|baseline to month seven|||microns|Participants|Standard Deviation|Mean
651111|NCT02036424|Primary|Mean Visual Acuity Change|Visual acuity was obtained using ETDRS method and the total number of letters correct using that method was used to calculate mean visual acuity change.|baseline to month 7|||ETDRS letters|Participants|Standard Deviation|Mean
651112|NCT02036320|Primary|"Lens Does Not Exhibit Hula Hoop Effect"|"The number of subjects that did not exhibit a hula hoop effect as recorded by Eye Care Practitioner (ECP) judgment of acceptable physiology, in primary gaze, without a slit lamp."|15 mins post insertion|The analysis population consists of subjects that completed all study visits, without a major protocol deviation||Subject|||Number
651113|NCT02036320|Primary|Cosmetic Lens Fit Acceptance|The number of subject eyes that were classified as having acceptable cosmetic lens fit in primary gaze, without a slit lamp.|15 mins post insertion|The analysis population consists of subjects that completed all study visits without a major protocol deviation.||Eyes|Participants||Number
651114|NCT02036320|Primary|Mechanical Lens Fit Acceptance|The number of subject eyes that were classified as having acceptable mechanical lens fit, with a slit lamp.|15 mins post insertion|The analysis population consists of subjects that completed all study visits without a major protocol deviation.||Eyes|Participants||Number
651115|NCT02035748|Secondary|Mean Nonsurgical Change From Baseline in Central Foveal Thickness (CFT)|Nonsurgical change in central foveal thickness (CFT values after a vitrectomy were imputed with the last non-missing value prior to the vitrectomy) was determined by subtracting the measurements in subretinal fluid and retinal pigment epithelium (RPE) elevations and/or SHRM (subretinal hyper-reflective material, such as choroidal neovascularization (CNV)) from the value in total retinal measurement. A lower CFT indicates improvement. One eye (study eye) contributed to the analysis.|Baseline (Day 0), Day 28, Day 180|Full Analysis Set. Missing data is imputed using LOCF. CFT values after a vitrectomy were imputed with the last non-missing value prior to the vitrectomy.||micrometers||Standard Deviation|Mean
651116|NCT02035748|Secondary|Proportion of Subjects Experiencing Pars Plana Vitrectomy (PPV) at Day 180|Pars plana vitrectomy (the surgical removal of vitreous gel from the eye) was captured in Concomitant Ocular Procedures. Proportion of subjects is reported as a percentage. One eye (study eye) contributed to the analysis.|Day 180|Full Analysis Set||percentage of subjects|||Number
651117|NCT02035748|Secondary|Proportion of Subjects With Nonsurgical Resolution of VMT/sVMA|Vitreous separation was assessed by SD-OCT using scores ranging from 1 (vitreous attached from macula to ON; separated elsewhere cannot determine foveal) to 12 (unable to determine state of separation). Nonsurgical resolution was defined as a change from baseline score of 5/6/8 to 7/9/10 at Day 90 and Day 180. The assessment of resolution of VMT/sVMA was based upon the anatomical resolution of VMA only, i.e. no resolution of the related symptoms was considered. Thus, the term VMA is used interchangeably with VMT/sVMA. Proportion of subjects is presented as a percentage, with percentage based on the number of subjects who have VMT/sVMA at baseline and SD-OCT value at Day 90/Day 180. One eye (study eye) contributed to the analysis.|Baseline, Day 90, Day 180|Full Analysis Set. Missing data imputed using LOCF. Subjects who had vitrectomy after VMT/sVMA resolution were considered as 'no resolution' after the timepoint of vitrectomy.||percentage of subjects|||Number
651118|NCT02035748|Secondary|Proportion of Subjects With Nonsurgical Closure of Macular Hole (MH), if Present at Baseline|The closure of macular hole (a full thickness defect of the retinal tissue involving the anatomical fovea) is defined as a flattened and reattached hole rim along the whole circumference of macular hole. Closure was determined by SD-OCT evaluation and the percentage of subjects tabulated. Proportion of subjects is presented as a percentage, with percentage based on the number of subjects who had macular hole at baseline and OCT value at each specific visit. One eye (study eye) contributed to the analysis.|Day 28, Day 90, Day 180|Full Analysis Set. Missing data imputed using LOCF. Subjects who had vitrectomy after MH closure were considered as 'no MH closure' after the timepoint of vitrectomy.||percentage of subjects|||Number
651119|NCT02035748|Secondary|Nonsurgical Change From Baseline in Best-corrected Visual Acuity (BCVA) at Distance|BCVA (with spectacles or other visual corrective devices) was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) testing at 4 meters. The charts contain 14 rows of letters. BCVA was calculated as the number of letters read correctly and improvement defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.|Baseline (Day 0), Day 28, Day 90, Day 180|Full Analysis Set. Missing data imputed using LOCF. BCVA values after a vitrectomy were imputed with the last non-missing value prior to the vitrectomy.||letters||Standard Deviation|Mean
651149|NCT02034591|Secondary|Adjusted Geometric Mean of the Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] of Apixaban|AUC(0-T) is measured in nanogram hours per milliliter (ng*h/mL)|Pre-dose and 0.25, 0.50, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, 72 hours post-dose for each intervention|All randomized participants with available PK data||ng*h/mL||90% Confidence Interval|Geometric Mean
651416|NCT02029495|Secondary|Psoriasis Area and Severity Index (PASI)75|PASI75 indicates that the subject has had a response of a 75% reduction on the severity of the psoriasis area based of off effected area size, erythema, scaling, and itching.|16 Weeks|||percentage of participants||95% Confidence Interval|Number
651120|NCT02035748|Primary|Proportion of Subjects With Nonsurgical Resolution of Focal Vitreomacular Traction (VMT/VMA) at Day 28, as Determined by Central Reading Center (CRC) Spectral Domain Optical Coherence Tomography (SD‐OCT) Evaluation|Vitreous separation was assessed by SD-OCT using scores ranging from 1 (vitreous attached from macula to ON; separated elsewhere cannot determine foveal) to 12 (unable to determine state of separation). Nonsurgical resolution was defined as a change from baseline score of 5/6/8 to 7/9/10 at Day 28. The assessment of resolution of VMT/sVMA was based upon the anatomical resolution of VMA only, i.e. no resolution of the related symptoms was considered. Thus, the term VMA is used interchangeably with VMT/sVMA. Proportion of subjects is presented as a percentage, with percentage based on the number of subjects who have VMT/sVMA at baseline and SD-OCT value at Day 28. One eye (study eye) contributed to the analysis.|Baseline, Day 28|This analysis population includes all subjects who received treatment with IP and had at least one post-treatment measurement of SD-OCT (FAS). Missing data imputed using the last observation carried forward (LOCF) method. Subjects who had vitrectomy after VMT/sVMA resolution were considered as 'no resolution' after timepoint of vitrectomy.||percentage of subjects|||Number
651148|NCT02034591|Secondary|Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths or Discontinuation of Study Drug Due to AEs|AE=any new unfavorable symptom, sign or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity or drug dependency/abuse; is life-threatening, an important medical event or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible or missing relationship to study drug. Death=during the study and up to 28 days past study discontinuation. The select AEs were determined using the Medical Dictionary for Regulatory Activities (MedDRA, v15.1) and graded using the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0|Day 1 to 30 days after last dose of study drug|All randomized participants||participants|||Number
663854|NCT01797029|Secondary|Safety Profile of LAIV: Serious Adverse Events||Through 16 to 19 months post-vaccination||||||
651133|NCT02035475|Secondary|Surgical Complications|Evaluate perioperative and postoperative surgical outcomes at 4 months after surgery. Possible outcomes include “no complications” (0), “minor complications” (1), and “major complications” (2).|4 months|||participants|||Number
651134|NCT02035475|Primary|Incidence of Lymphoceles|Identify whether the use of the Vessel Sealer for PLND reduces the incidence of screening detected lymphoceles via CT scan of the pelvis by comparing the Vessel Sealer side of the pelvis with the control side of the pelvis.|4 months|Lymphoceles were identified by CT scan at 3 months post surgery.||participants|||Number
651135|NCT02035345|Primary|Number of Patients With Carboplatin Reactions of Different Severity|To characterize the nature and symptoms of carboplatin reactions associated with the slowed infusion protocol.|2 Years|Among the 15 patients enrolled, the HSR rate was 40% which occurred after a median of 2 protocol treatments, which prompted early termination of this study.||participants|||Number
651136|NCT02035345|Primary|Number of Participants With Carboplatin Infusion Hypersensitivity Reactions Using a Slowed Carboplatin Infusion Program|To determine the frequency of carboplatin infusion hypersensitivity reactions using a slowed carboplatin infusion program|2 Years|Total number of patients in the study that received carboplatin via slowed infusion.||participants|||Number
651137|NCT02035332|Post-Hoc|Subjects With Amenorrhea at 12 Months|Amenorrhea at 12 Months- Number of Subjects experiencing no menstrual bleeding|12 Months|Protocol Intent-to-treat||participants|||Number
651138|NCT02035332|Secondary|Procedure Time|Procedure time defined as time from insertion of the Disposable Handpiece to the time of removal.|Day of procedure|Subjects completing treatment||Minutes||Standard Deviation|Mean
651139|NCT02035332|Primary|Reduction in Menstrual Blood Loss to Normal Levels at 12-months|Number of subjects in whom menstrual blood loss was reduced to normal or below normal levels at 12 months, as measured by a pictorial blood loss assessment chart (PBLAC) score of <=75. A score of 0 represents no bleeding.|12 Months|Protocol Intent-to-treat population (all subjects in whom the experimental device was attempted to be placed.)||participants|||Number
651140|NCT02034877|Primary|Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After 13vPnC Vaccination|Percentage of participants achieving serotype-specific pneumococcal OPA titer >=LLOQ, along with the corresponding 95% CIs for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) are presented. Exact 2-sided CIs for the observed proportion of participants were calculated using Clopper and Pearson method. LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43; Pn7F, 210 (for adult participants); Pn7F, 113 (for pediatric participants) Pn09V, 345 (for adult participants); Pn09V, 141 (for pediatric participants); Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; Pn23F, 13. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure.|1 month after 13vPnC vaccination|Evaluable immunogenicity population: eligible participants received 13vPnC;had blood drawn within pre-specified time-frames with at least 1 valid,determinate assay result,no major protocol violation. Only 400 adults were selected for immunogenicity analysis, ‘n’=number of participants with valid and determinate assay results for specified serotype.||Percentage of participants||95% Confidence Interval|Number
651343|NCT02030535|Secondary|Mean RR (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points|Mean RR change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)||ms||Standard Deviation|Mean
651141|NCT02034877|Primary|Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) Before 13vPnC Vaccination|Percentage of participants achieving serotype-specific pneumococcal OPA titer >=LLOQ, along with the corresponding 95% CIs for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) are presented. Exact 2-sided CIs for the observed proportion of participants were calculated using Clopper and Pearson method. LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43; Pn7F, 210 (for adult participants); Pn7F, 113 (for pediatric participants) Pn09V, 345 (for adult participants); Pn09V, 141 (for pediatric participants); Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; Pn23F, 13. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure.|Before 13vPnC vaccination|Evaluable immunogenicity population: eligible participants received 13vPnC;had blood drawn within pre-specified time-frames with at least 1 valid,determinate assay result,no major protocol violation. Only 400 adults were selected for immunogenicity analysis, ‘n’=number of participants with valid and determinate assay results for specified serotype.||Percentage of participants||95% Confidence Interval|Number
651142|NCT02034877|Primary|Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Vaccination to 1 Month After 13vPnC Vaccination|GMFRs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC vaccination to 1 month after 13vPnC vaccination were computed using the logarithmically transformed assay results. CIs for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both before and after vaccination blood draws. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure.|Before 13vPnC vaccination, 1 month after 13vPnC vaccination|Evaluable immunogenicity population: eligible participants received 13vPnC;had blood drawn within pre-specified time-frames with at least 1 valid,determinate assay result,no major protocol violation. Only 400 adults were selected for immunogenicity analysis, ‘n’=number of participants with valid and determinate assay results for specified serotype.||Fold rise||95% Confidence Interval|Geometric Mean
651143|NCT02034877|Primary|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After 13vPnC Vaccination|Antibody-mediated opsonophagocytic activity against each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were measured using a quantitative functional OPA assay. OPA titers were expressed as the reciprocal of the highest serum dilution that reduces survival of the pneumococci by at least 50%. For each serotype, GMTs were calculated using the logarithmically transformed assay results. CIs for GMTs were back transformations of a CI based on the Student t distribution for the mean of the logarithmically transformed assay results. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure.|1 month after 13vPnC vaccination|Evaluable immunogenicity population: eligible participants received 13vPnC;had blood drawn within pre-specified time-frames with at least 1 valid,determinate assay result,no major protocol violation. Only 400 adults were selected for immunogenicity analysis, ‘n’=number of participants with valid and determinate assay results for specified serotype.||Titers||95% Confidence Interval|Geometric Mean
651144|NCT02034877|Primary|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before 13vPnC Vaccination|Antibody-mediated opsonophagocytic activity against each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were measured using a quantitative functional OPA assay. OPA titers were expressed as the reciprocal of the highest serum dilution that reduces survival of the pneumococci by at least 50 percent (%). For each serotype, GMTs were calculated using the logarithmically transformed assay results. Confidence intervals (CIs) for GMTs were back transformations of a CI based on the Student t distribution for the mean of the logarithmically transformed assay results. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure.|Before 13vPnC vaccination|Evaluable immunogenicity population: eligible participants received 13vPnC;had blood drawn within pre-specified time-frames with at least 1 valid,determinate assay result,no major protocol violation. Only 400 adults were selected for immunogenicity analysis, ‘n’=number of participants with valid and determinate assay results for specified serotype.||Titers||95% Confidence Interval|Geometric Mean
651145|NCT02034877|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) Within 1 Month After 13vPnC Vaccination|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 1 month after last dose that were absent before treatment or that worsened relative to pre-treatment state.|Within 1 month after 13vPnC vaccination|Safety population included all participants who received 1 dose of 13vPnC vaccination.||Percentage of participants|||Number
651146|NCT02034708|Primary|Percentage of Patients With Overall Lesion Visualization and Characterization Scored as Good or Excellent|"Overall lesion visualization and characterization, based on assessment of the primary or largest lesion if there is more than one lesion present, was assessed by 3 independent off-site readers on a 4-point scale:
0. Poor: does not allow adequate visualization and characterization of the lesion; 1. Fair: allows partial visualization and characterization of the lesion ; 2. Good: allows adequate visualization and characterization of the lesion; 3. Excellent: allows excellent visualization and characterization of the lesion."|Up to 15 days after randomization|Patients with at least one valid assessment of the primary outcome and without major protocol deviation||percentage of patients|||Number
651147|NCT02034591|Secondary|Number of Participants With Marked Laboratory Abnormalities|Marked laboratory abnormalities were defined as laboratory assessments meeting the following investigator-specified criteria: Leukocytes >1.2* upper limits of normal (ULN) , Basophils >3%, Eosinophils >1.5*ULN, Blood Urine >=2, Red Blood Cell (RBC) Urine >=2, White Blood Cell (WBC) Urine >=2|Day 1 to 30 days after last dose of study drug|All randomized participants||participants|||Number
651150|NCT02034591|Secondary|Adjusted Geometric Mean of the Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of Apixaban|AUC(INF) is measured in nanogram hours per milliliter (ng*h/mL)|Pre-dose and 0.25, 0.50, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, 72 hours post-dose for each intervention|All randomized participants with available PK data||ng*h/mL||90% Confidence Interval|Geometric Mean
651152|NCT02034591|Primary|Adjusted Geometric Mean of the Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] of Apixaban|AUC(0-T) is measured in nanogram hours per milliliter (ng*h/mL)|Pre-dose and 0.25, 0.50, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, 72 hours post-dose for each intervention|All randomized participants with available PK data||ng*h/mL||90% Confidence Interval|Geometric Mean
651153|NCT02034591|Primary|Adjusted Geometric Mean of the Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero Extrapolated to Infinite Time AUC(INF) of Apixaban|AUC(INF) is measured in nanogram hours per milliliter (ng*h/mL)|Pre-dose and 0.25, 0.50, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, 72 hours post-dose for each intervention|All randomized participants with available PK data||ng*h/mL||90% Confidence Interval|Geometric Mean
651154|NCT02034591|Primary|Adjusted Geometric Mean of the Maximum Observed Plasma Concentration (Cmax) of Apixaban|Maximum observed plasma concentration (Cmax) is measured in nanograms per milliliter (ng/mL)|Pre-dose and 0.25, 0.50, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, 72 hours post-dose for each intervention|All randomized participants with available pharmacokinetic (PK) data||ng/mL||90% Confidence Interval|Geometric Mean
651155|NCT02034578|Secondary|Number of Participants With Marked Abnormality in Hematology, Chemistry and Urinalysis Laboratory Tests|Participants were required to fast for at least 10 hours prior to the collection of specimens for clinical laboratory tests. Tests were performed at Screening, Day -1, and Day 4 of each period 1 - 3. Leukocyte criteria: Lower limits of normal (LLN), upper limits of normal (ULN), pre-treatment (preRX). Low Leukocytes: if value < 0.9*LLN, or if preRX < LLN then use < 0.85* preRX. High lymphocytes: if value > 7.500 10^3 cells/ µL. Low neutrophils plus bands: if value <= 1.500 10^3 cells/µL. High creatine kinase: if value > 1.5* ULN. Blood in urine: if value >= 2 plus, or if preRX >= 1 plus then use >= 2*preRX.|Screening, Day -1, Day 4 of Periods, 1, 2, and 3|Participants who received study drug were analyzed.||participants|||Number
651156|NCT02034578|Secondary|Number of Participants With Clinically Significant Electrocardiogram, Vital Sign, or Physical Examination Findings|12-lead electrocardiograms (ECGs) and Vital Signs were performed at Screening, and Day 1 of Periods 1, 2 and 3 (pre-dose and prior to NGT placement, if done). Vital signs and ECGs were also performed on Day 4 of Period 3, prior to discharge from the study. Vital signs included body temperature, respiratory rate, seated blood pressure and heart rate. Blood pressure and heart rate were measured after the participant had been seated quietly for at least 5 minutes. Participants had physical examinations on Period 1, Day 1 (pre-dose) and Day 4 of Period 3, prior to study discharge.|Screening, Day 1 of Periods, 1, 2, and 3, and Day 4 of Period 3|All participants who received study drug were analyzed.||participants|||Number
651157|NCT02034578|Secondary|Mean Plasma Elimination Half-Life (T-HALF) of Apixaban|Samples of plasma from participants were obtained at the following times: 0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h, relative to the single dose on Day 1 in each cross over period. Apixaban was assayed using a validated LC-MS/MS method during the period of known analyte stability. T-HALF was measured in hours (h).|Day 1 (0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h post dose) in Periods 1, 2 and 3|All participants who received study drug and had adequate PK profiles were included in the analysis.||h||Standard Deviation|Mean
651158|NCT02034578|Secondary|Adjusted Geometric Mean Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time, AUC(INF), of Apixaban|Samples of plasma from participants were obtained at the following times: 0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h, relative to the single dose on Day 1 in each cross over period. Apixaban was assayed using a validated LC-MS/MS method during the period of known analyte stability. AUC(0-INF) was measured in ng*h/mL.|Day 1 (0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h post dose) in Periods 1, 2 and 3|All participants who received study drug and had adequate PK profiles were included in the analysis.||ng*h/mL||90% Confidence Interval|Geometric Mean
651159|NCT02034578|Secondary|Adjusted Geometric Mean Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of Last Quantifiable Plasma Concentration, AUC(0-T), of Apixaban|Samples of plasma from participants were obtained at the following times: 0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h, relative to the single dose on Day 1 in each cross over period. Apixaban was assayed using a validated LC-MS/MS method during the period of known analyte stability. AUC(0-T) was measured in nanograms*hours per milliliter (ng*h/mL).|Day 1 (0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h post dose) in Periods 1, 2 and 3|All participants who received study drug and had adequate PK profiles were included in the analysis.||ng*h/mL||90% Confidence Interval|Geometric Mean
651160|NCT02034578|Secondary|Median Time of Maximum Observed Plasma Concentration (Tmax) of Apixaban|Samples of plasma from participants were obtained at the following times: 0 hour (h), 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h, relative to the single dose on Day 1 in each cross over period. Apixaban was assayed using a validated LC-MS/MS method during the period of known analyte stability. Maximum observed plasma concentration (Tmax) was measured in hours (h).|Day 1 (0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h post dose) in Periods 1, 2 and 3|||h||Full Range|Median
651161|NCT02034578|Primary|Adjusted Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Apixaban|Samples of plasma from participants were obtained at the following times: 0 hour (h) and post dose at 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h. Apixaban was assayed using a validated Liquid chromatography tandem mass spectrometry (LC-MS/MS) method during the period of known analyte stability. Maximum observed plasma concentration (Cmax) was measured in nanograms per milliliter (ng/mL).|Day 1 (0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h post dose) in Periods 1, 2 and 3|All participants who received study drug and had adequate PK profiles were included in the analysis.||ng/mL||90% Confidence Interval|Geometric Mean
651162|NCT02034578|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs, Death|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|Day 1 to Day 12|All participants who received study drug were analyzed.||participants|||Number
655257|NCT01953328|Secondary|Percent Change From Baseline in Total Cholesterol at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
651163|NCT02034565|Secondary|Number of Participants With Marked Laboratory Abnormalities|Clinical laboratory tests were performed pre-study and at selected times throughout the study. Marked laboratory abnormalities were defined as laboratory assessments meeting the following investigator-specified criteria: Leukocytes < 0.9* lower limits of normal (LLN), absolute neutrophils + bands <= 1.500 10*3 cells/microliter, white blood cells (WBC) urine value >= 2+. These laboratory abnormalities were not considered clinically significant and therefore not adverse events.|Pre-study screen (Day -1) to Day 8 or day of study discharge|All treated participants||participants|||Number
651164|NCT02034565|Secondary|Number of Participants With Serious Adverse Events (SAEs), Treatment-Related Adverse Events (AEs), Deaths or Discontinuation of Study Drug Due to AEs|AE=any new unfavorable symptom, sign or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity or drug dependency/abuse; is life-threatening, an important medical event or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible or missing relationship to study drug. Death=during the study and up to 28 days past study discontinuation. The select AEs were determined using the Medical Dictionary for Regulatory Activities (MedDRA, v13).|Day 1 to 30 days after last dose of study drug|All treated participants||participants|||Number
651165|NCT02034565|Primary|Adjusted Geometric Mean of the Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] of Apixaban|Serial blood samples for pharmacokinetic analysis were collected at selected times up to 72 hours after each dose. AUC(0-T) is measured in nanogram hours per milliliter (ng*h/mL)|Pre-dose and 0.25, 0.50, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, 72 hours post-dose per intervention|All treated participants with available pk data||ng*h/mL||90% Confidence Interval|Geometric Mean
651166|NCT02034565|Primary|Adjusted Geometric Mean of the Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero Extrapolated to Infinite Time AUC(INF) of Apixaban|Serial blood samples for pharmacokinetic analysis were collected at selected times up to 72 hours after each dose. AUC(INF) is measured in nanogram hours per milliliter (ng*h/mL)|Pre-dose and 0.25, 0.50, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, 72 hours post-dose per intervention|All treated participants with available pk data||ng*h/mL||90% Confidence Interval|Geometric Mean
651167|NCT02034565|Primary|Adjusted Geometric Mean of the Maximum Observed Plasma Concentration (Cmax) of Apixaban|Serial blood samples for pharmacokinetic analysis were collected at selected times up to 72 hours after each dose. Maximum observed plasma concentration (Cmax) is measured in nanograms per milliliter (ng/mL)|Pre-dose and 0.25, 0.50, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, 72 hours post-dose per intervention|All treated participants with available pharmacokinetic (pk) data||ng/mL||90% Confidence Interval|Geometric Mean
651168|NCT02034552|Secondary|Overall Survival (OS)||From randomization to the date of radiological disease progression, up to 7.5 years|Data were not collected and are anticipated to be reported in November, 2018.|||||
651169|NCT02034552|Secondary|Time to First Symptomatic Skeletal Event (SSE)||From randomization to first SSE or death, up to 30 months|Data were not collected and are anticipated to be reported in November, 2018.|||||
651170|NCT02034552|Secondary|Symptomatic Skeletal Event-free Survival (SSE-FS)||From randomization to the earlier SSE or death, up to 30 months|Data were not collected and are anticipated to be reported in November, 2018.|||||
651171|NCT02034552|Secondary|Time to Radiological Bone Progression by Treatment Group||From randomization to radiological bone progression up to 30 months|Data were not collected and are anticipated to be reported in November, 2018.|||||
651172|NCT02034552|Secondary|Radiological Progression-free Survival (rPFS)||From randomization to radiological disease progression or death from any cause, up to 30 months|Data were not collected and are anticipated to be reported in November, 2018.|||||
651173|NCT02034552|Primary|Patient Bone Scan Response Rate|Radiological bone scan response based on change from baseline of digitized technetium-99 bone scans using computer-aided detection software. Responder (R): 30% or greater resolution of the BSLA compared to baseline. Stable Disease (SD): Not meeting the criteria for R, PD, or UE. Progressive Disease (PD): Two or more new areas of radiotracer uptake attributable to metastatic disease in regions of bone that had not previously shown radiotracer uptake or greater than 30% increase from baseline in BSLA attributable to metastatic disease. Unable to Evaluate (UE): Assigned if bone scan results cannot be interpreted due to inconsistent image acquisition parameters compared to the reference scan, incomplete imaging, or other similar technical deficiencies.|At 24 weeks|Imaging endpt analysis set (IMG): consists of mITT subj. (ITT subj. who received at least one dose of each study drug as randomized) with evaluable imaging scan at baseline, eg. bl quantitated technetium-99 bone scan imaging of sufficient completeness and quality to be assessable and having a non-zero BSLA, as determ. by the central reviewer.||Percentage|||Number
651174|NCT02034513|Secondary|FPG (Fasting Plasma Glucose)|Fasting plasma glucose values at week 32 and week 64.|Week 32 and Week 64|Results are based on the FAS. Here, 'n' specifies the number of subjects with available data at specified time-point.||mmol/L||Standard Deviation|Mean
651175|NCT02034513|Secondary|Change From Baseline in HbA1c (Glycosylated Haemoglobin)|Change from baseline in HbA1c (glycosylated haemoglobin) at week 32 (treatment period 1) and at week 64 (treatment period 2). Week 32 HbA1c absolute value was considered as baseline for calculating change from baseline in HbA1c at week 64.|Week 32, Week 64|Both descriptive analysis and statistical analysis were based on the FAS. Here, 'n' specifies the number of subjects with available data at specified time-point.||Percentage of glycosylated haemoglobin||Standard Deviation|Mean
651176|NCT02034513|Secondary|Incidence of Treatment Emergent Adverse Events|Treatment emergent adverse event was defined as an event with onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.|During 32 weeks of treatment for each treatment period|The trial followed a cross over design. Results are based on the SAS.||Event|||Number
651208|NCT02032901|Primary|Percentage of Treatment-Experienced Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) Target Detected (TD) or Target Not Detected (TND)|SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation ie., 25 IU/mL, target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 12 (Follow-up period)|The analysis was performed in all treated participants who received at least 1 dose of active study therapy.||percentage of participants||95% Confidence Interval|Number
651177|NCT02034513|Secondary|Proportion of Subjects With One or More Severe Hypoglycaemic Episodes During the Maintenance Period|Percentage of subjects who experienced one or more severe hypoglycaemic episodes during the maintenance period. Severe hypoglycaemia (according to the American Diabetes Association 2013 definition): A hypoglycaemic episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose values may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration.|After 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64)|The trial followed a cross over design. Descriptive analysis was based on the SAS. Number of subjects analysed=subjects in the SAS, who were exposed in at least one maintenance period.||Percentage of subjects|||Number
651178|NCT02034513|Secondary|Number of Treatment Emergent Severe or BG Confirmed Symptomatic Nocturnal Hypoglycaemic Episodes During the Maintenance Period|Severe or BG confirmed symptomatic nocturnal hypoglycaemic episodes were defined as episodes that were severe and/or BG confirmed by a plasma glucose value of <3.1 mmol/L (56 mg/dL), with symptoms consistent with hypoglycaemia and with time of onset between 00:01 and 05.59 a.m., both inclusive. Treatment emergent hypoglycaemic episode was defined as an event with onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.|After 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64)|The trial followed a cross over design. Descriptive analysis was based on the SAS. Number of subjects analysed=subjects in the SAS, who were exposed in at least one maintenance period.||Event|||Number
651179|NCT02034513|Primary|Number of Treatment Emergent Severe or BG (Blood Glucose) Confirmed Symptomatic Hypoglycaemic Episodes During the Maintenance Period|Severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe and/or BG confirmed by a plasma glucose value of <3.1 mmol/L (56 mg/dL), with symptoms consistent with hypoglycaemia. Treatment emergent hypoglycaemic episode was defined as an event with onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment. Maintenance period: 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64).|A 16-week treatment period.|The trial followed a cross over design. Descriptive analysis was based on the safety analysis set (SAS: subjects receiving at least 1 dose of the investigational product, IDeg or its comparator, IGlar). Number of subjects analysed=subjects in the SAS, who were exposed in at least one maintenance period.||Event|||Number
651180|NCT02034162|Secondary|Area Under the Plasma Concentration-Time Curve From Time Zero to Time of the Last Quantifiable Concentration AUC(0-last) of Mebendazole|The (AUC [0-last]) is the area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration.|Predose, 1, 2, 3, 5, 8 and 24 hours postdose at visit 4 (Day 20; 1 day after Visit 3)|PK population included all randomized participants who received at least 1 dose of the study drug and had valid pharmacokinetic profile. Here 'N' signifies number of participants analysed for this outcome measure.||ng*h/mL||Standard Deviation|Mean
651181|NCT02034162|Secondary|Area Under the Plasma Concentration-time Curve From Time 0 to 8 Hours (AUC8h) of Mebendazole|The (AUC8h) is the area under the plasma concentration-time curve from time 0 to 8 hours Post-dose.|Predose, 1, 2, 3, 5, 8 and 24 hours postdose at visit 4 (Day 20; 1 day after Visit 3)|PK population included all randomized participants who received at least 1 dose of the study drug and had valid pharmacokinetic profile. Here 'N' signifies number of participants analysed for this outcome measure.||nanogram hour per Milliliters(ng*h/mL)||Standard Deviation|Mean
651182|NCT02034162|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Mebendazole|The Time to Reach Maximum Plasma Concentration (Tmax) is time to reach the maximum plasma concentration.|Predose, 1, 2, 3, 5, 8 and 24 hours postdose at visit 4 (Day 20; 1 day after Visit 3)|PK population included all randomized participants who received at least 1 dose of the study drug and had valid pharmacokinetic profile. Here 'N' signifies number of participants analysed for this outcome measure.||hours||Full Range|Mean
651183|NCT02034162|Primary|Number of Participants Reporting Treatment Emergent Adverse Event (TEAE) in Open-Label Treatment Period|An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|At Visit 3 (Day 19+/-2) followed up to Visit 5 (Day 7+/-1 from Visit 3)|The open-label follow-up safety analysis set consisted of all randomized participants who received a 500-mg chewable tablet of mebendazole at Visit 3. Here 'N' signifies number of participants analysed for this outcome measure.||participants|||Number
651184|NCT02034162|Secondary|Maximum Plasma Concentration (Cmax) of Mebendazole|The Cmax is the maximum plasma concentration.|Predose, 1, 2, 3, 5, 8 and 24 hours postdose at visit 4 (Day 20; 1 day after Visit 3)|Pharmacokinetic (PK) population included all randomized participants who received at least 1 dose of the study drug and had valid pharmacokinetic profile. Here 'N' signifies number of participants analysed for this outcome measure.||nanogram per Milliliters (ng/mL)||Standard Deviation|Mean
651185|NCT02034162|Secondary|Egg Count Reduction Rate (Percent) for Trichuris Trichiura Infestation at the End of Double-blind Treatment Period|Percent egg count reduction is calculated as average egg count at end of treatment period of a treatment group minus average egg count at baseline of the treatment group divided by average egg count at baseline of the treatment group.|Baseline and Day 19 (Visit 3) at the End of Double-blind Treatment Period|The ITT analysis set included all randomized participants with a pretreatment stool sample positive for 1 or more worms of interest. Here 'N' signifies number of participants analysed for this outcome measure.||percent change in egg count|||Number
651186|NCT02034162|Secondary|Egg Count Reduction Rate (Percent) for Ascaris Lumbricoides Infestation at the End of Double-blind Treatment Period|Percent egg count reduction is calculated as average egg count at end of treatment period of a treatment group minus average egg count at baseline of the treatment group divided by average egg count at baseline of the treatment group.|Baseline and Day 19 (Visit 3) at the End of Double-blind Treatment Period|The ITT analysis set included all randomized participants with a pretreatment stool sample positive for 1 or more worms of interest. Here 'N' signifies number of participants analysed for this outcome measure.||percent change in egg count|||Number
655258|NCT01953328|Secondary|Percent Change From Baseline in Total Cholesterol at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
651187|NCT02034162|Primary|Number of Participants Reporting Treatment Emergent Adverse Event (TEAE) in Double-Blind Treatment Period|An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Up to Visit 3 (Day 19 +/-2)|The safety analysis set consisted of all randomized participants who received 1 dose of study agent (mebendazole or placebo) at baseline. Here 'N' signifies number of participants analysed for this outcome measure.||participants|||Number
651188|NCT02034162|Primary|Cure Rate for Trichuris Trichiura at the End of Double-blind Treatment Period|Cure is defined as a post-treatment egg count of zero in participants who had a positive egg count at baseline.|At Visit 3 (Day 19) of Double-blind treatment period|The ITT analysis set included all randomized participants with a pretreatment stool sample positive for 1 or more worms of interest. Here 'N' signifies number of participants analysed for this outcome measure.||percentage of participants||95% Confidence Interval|Number
651189|NCT02034162|Primary|Cure Rate for Ascaris Lumbricoides at the End of Double-blind Treatment Period|Cure is defined as a post-treatment egg count of zero in participants who had a positive egg count at baseline.|At Visit 3 (Day 19) of Double-blind treatment period|The intent-to-treat (ITT) analysis set included all randomized participants with a pretreatment stool sample positive for 1 or more worms of interest. Here 'N' signifies number of participants analysed for this outcome measure.||percentage of participants||95% Confidence Interval|Number
651190|NCT02033317|Primary|Change From Baseline in Fecal Potassium Excretion (Day -7 Through Day -1) and Treatment (Day 1 Through 7)||Day -7 Through Day -1 and Day 1 Through Day 7|||mg/Day||Standard Deviation|Mean
651191|NCT02033317|Primary|Change in Serum Potassium (Day 1 to Day 8)||Day 1 and Day 8|||mmol/L||Standard Deviation|Mean
651192|NCT02033213|Secondary|Total Volume of Administered Intraoperative Fluid|Total volume of intraoperatively given fluid according to the protocol will be measured and compared between two groups.|End of surgery|||milliliters||Standard Deviation|Mean
651193|NCT02033213|Secondary|Duration of Surgery|Total time of Lewis-Tanner procedure will be measured and compared between two groups.|End of surgery.|||minutes||Standard Deviation|Mean
651194|NCT02033213|Primary|Changes in Lactate Levels During Esophageal Carcinoma Surgery Using Restrictive or Liberal Fluid Management.|At the given time points, ten minutes after beginning of the Lewis Tanner procedure and six hours after procedure, blood levels of the lactate will be measured and compared inside the same group (liberal or restrictive).|10 minutes, 6 hours|||mmol/L||Standard Deviation|Mean
651195|NCT02033213|Primary|Lactate Values During and After Esophageal Carcinoma Surgery|At the given time points, ten minutes after beginning of the Lewis Tanner procedure and six hours after procedure, blood levels of the lactate will be measured and compared between two groups for each time point separately.|10 minutes, 6 hours|||mmol/L||Standard Deviation|Mean
651196|NCT02033213|Primary|Creatinine Values During and After Esophageal Carcinoma Surgery|At the given time points, 10 minutes after beginning of the Lewis Tanner procedure and 6 hours after, creatinine blood levels will be measured. The results will be compared between two groups for each time point separately.|10 minutes, 6 hours|||μmol/L||Standard Deviation|Mean
651197|NCT02033213|Primary|Pulmonary Gas Exchange During and After Esophageal Carcinoma Surgery (PaO2/FiO2 Ratio)|At the given time point, 10 minutes after beginning of the Lewis Tanner procedure and 6 hours after, arterial oxygen partial pressure (PaO2), inspired oxygen fraction (FiO2), and the PaO2/FiO2 ratio will be measured. The results of Pa02/FiO2 ratio will be compared between two groups for each time point separately.|10 minutes, 6 hours|||mmHg||Standard Deviation|Mean
651198|NCT02033200|Secondary|Change From Baseline in Intraocular Pressure 24 Hour Post Dosing|Intraocular pressure was measuring using the Goldman applanation tonometry|24 hours|||mm Hg||Standard Deviation|Mean
651199|NCT02033200|Secondary|Change From Baseline in Color Vision Discrimination 24 Hour Post Dosing||24 hours|||total error score||Standard Deviation|Mean
651200|NCT02033200|Secondary|Change From Baseline in Pupil Dilation 24 Hour Post Dosing||24 hour|||mm||Standard Deviation|Mean
651201|NCT02033200|Secondary|Change From Baseline in Visual Acuity 24 Hours Post Dosing||24 hours|||LogMar||Standard Deviation|Mean
651202|NCT02033200|Primary|Change From Baseline in Intraocular Pressure 1 Hour Post Dosing|Intraocular Pressure was measured using the Goldman applanation tonometry|1 hour|||mm Hg||Standard Deviation|Mean
651203|NCT02033200|Primary|Change From Baseline in Pupil Dilation 1 Hour Post Dosing|Pupil dilation was measured using the Neuroptics Model VIP 200 pupillometer under standard lighting conditions.|1 hour|||millimeter||Standard Deviation|Mean
651204|NCT02033200|Primary|Change From Baseline in Visual Acuity 1 Hour Post Dosing|Visual acuity was measured using the Logarithm of the Minimum Angle Resolution (LogMAR) chart. The LogMAR value of the best line read was noted and the number of letters read in the next row was multiplied by 0.02, then subtracted from the LogMAR value of the best line completely read.|1 hour|||LogMar||Standard Deviation|Mean
651205|NCT02033200|Primary|Change From Baseline in Color Vision Discrimination 1 Hour Post Dosing|Color vision discrimination was performed using the Lanthony 40-Hue Test according to Farnsworth-Munsell 100-Hue Test. The total error score was derived by counting the number of caps misplaced.|1 hour|||total error score||Standard Deviation|Mean
651206|NCT02033174|Primary|Change From Baseline in Concentrations of Antioxidant Profile After Red Wine Intake|In order to determine total antioxidant capacity a quantitative immunoassay using commercial kits (R&D Systems, Inc. Minneapolis, USA) was conducted.|Baseline and 5 days|All participants who completed all study visits were included||percentage of change in TAC||Inter-Quartile Range|Median
651207|NCT02032901|Secondary|Number of Participants With Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs)|AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.|From Day 1 first dose to last dose plus 7 days|The analysis was performed in all treated participants who received at least 1 dose of active study therapy.||Participants|||Number
663855|NCT01797029|Secondary|The Viral Etiologies of Acute Respiratory and Febrile Illness||Through 16 to 19 months post-vaccination||||||
651209|NCT02032901|Secondary|Percentage of Participants With CC or Non-CC Genotype at the IL28B rs12979860 Single Nucleotide Polymorphisms (SNPs) Who Achieved Sustained Virologic Response After 12 Weeks of Follow-up (SVR12)|Participants categorized into 2 genotypes (CC and non-CC) based on SNPs in the IL28B gene were assessed for SVR12, defined as response in which hepatitis C virus (HCV) RNA levels below lower limit of quantitation (LLOQ) below target detected or target not detected at follow-up Week 12 (LLOQ: 25 IU/mL). HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 12 (Follow-up period)|The analysis was performed in all treated participants who received at least 1 dose of active study therapy. Here, ''n'' signifies number of participants evaluable for the specified category.||Percentage of participants||95% Confidence Interval|Number
651210|NCT02032901|Secondary|Percentage of Participants With Or Without Cirrhosis at Baseline Who Achieved Sustained Virologic Response at Follow-up Week 12 (SVR12)|SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation ie. 25 IU/mL, target detected or target not detected at follow-up Week 12. Cirrhosis was considered a negative predictor of SVR in participants treated with an interferon formulation or ribavirin. Presence or absence of cirrhosis was determined at baseline and follow-up Week 12 in the participants to evaluate the post-treatment relapse.|Baseline, Week 12 (Follow-up period)|The analysis was performed in all treated participants who received at least 1 dose of active study therapy. The 'n' signifies the number of evaluable participants with or without cirrhosis in the reporting arm and time point, respectively.||Percentage of participants||95% Confidence Interval|Number
651211|NCT02032901|Secondary|Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Less Than the Lower Limit of Quantitation (LLOQ)- Target Detected (TD) or Target Not Detected (TND)|Percentage of participants who achieved HCV RNA <LLOQ,TD or TND was determined (LLOQ: 25 IU/mL). HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 1, 2, 4, 6, 8, 12, End of treatment (treatment period), Week 4 (follow-up period), Week 24 (follow-up period)|The analysis was performed in all treated participants who received at least 1 dose of active study therapy.||Percentage of participants||95% Confidence Interval|Number
651212|NCT02032901|Secondary|Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Less Than the Lower Limit of Quantitation (LLOQ) - Target Not Detected (TND)|Percentage of participants who achieved HCV RNA <LLOQ, TND was determined (LLOQ: 25 IU/mL). HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 1, 2, 6, 8 (treatment period)|The analysis was performed in all treated participants who received at least 1 dose of active study therapy.||Percentage of participants||95% Confidence Interval|Number
651213|NCT02032901|Secondary|Percentage of Participants With End of Treatment Response (EOTR) Target Not Detected (TND)|EOTR were defined as hepatitis C virus RNA levels to be < lower limit of quantitation ie, 25 IU/mL TND at end of treatment. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Up to the end of treatment (up to 24 weeks)|The analysis was performed in all treated participants who received at least 1 dose of active study therapy.||percentage of participants||95% Confidence Interval|Number
651214|NCT02032901|Secondary|Percentage of Participants With Complete Early Virologic Response (cEVR) Target Not Detected (TND)|cEVR was defined as hepatitis C virus RNA levels to be < lower limit of quantitation ie, 25 IU/mL TND at Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 12|The analysis was performed in all treated participants who received at least 1 dose of active study therapy.||Percentage of participants||95% Confidence Interval|Number
651215|NCT02032901|Secondary|Percentage of Participants With Rapid Virologic Response at Week 4 (RVR) Target Not Detected (TND)|RVR was defined as hepatitis C virus RNA levels to be < lower limit of quantitation ie, 25 IU/mL TND at Week 4. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 4|The analysis was performed in all treated participants who received at least 1 dose of active study therapy.||Percentage of participants||95% Confidence Interval|Number
651216|NCT02032901|Primary|Percentage of Treatment-Naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) Target Detected (TD) or Target Not Detected (TND)|SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation ie., 25 IU/mL, TD or TND at follow-up Week 12. HCV RNA levels were measured by the Roche Cobas® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 12 (Follow-up period)|The analysis was performed in all treated participants who received at least 1 dose of active study therapy.||Percentage of participants||95% Confidence Interval|Number
651217|NCT02032888|Secondary|Number of Participants With Treatment-emergent Grade 3-4 Abnormalities on Laboratory Test Results|Grade 3-4 abnormalities on laboratory test results were defined as: International normalized ratio as 2.1–3.0*upper limit of normal (ULN) for grade 3 and >3.0*ULN for grade 4. Leukocytes as 1.0*10^9–1.5*10^9/L for grade 3 and <1.0*10^9/L for grade 4. Aspartate aminotransferase as 5.1–10.0*ULN for grade 3 and >10.0*ULN for grade 4. Bilirubin (total) as 2.6–5.0*ULN for grade 3 and >5.0*ULN for grade 4. Lipase (total) as 3.1–5.0*ULN for grade 3 and >5.0*ULN for grade 4. Alanine aminotransferase as 5.1-10.0*ULN for grade 3 and >10.0*ULN for grade 4.|From screening up to week 24 of post treatment follow­-up|All participants who received at least 1 dose of study drug||Participants|||Number
651218|NCT02032888|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-related AEs/SAEs, Grade 3 to 4 AEs/SAEs, and Who Died During Follow-up Period|AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may or may not have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.|AEs: Day 1 of follow-up period (Week 9 or Week 13) to 7 days after end of 24 weeks follow-up period. SAEs: Day 1 of follow-up period (Week 9 or Week 13) to 30 days after end of 24 weeks follow-up period.|All participants who received at least 1 dose of study drug||Participants|||Number
651239|NCT02032706|Secondary|Assess the Accuracy of Night Shift's Detection of Sleep vs. Wake|Compare the epochs staged wake and sleep by the reference standard (polysomnography) to the epochs staged wake and sleep by Night Shift to determine the sleep (sensitivity) and wake (specificity) classification accuracy.|baseline and follow-up|||percentage of epochs||Standard Deviation|Mean
651219|NCT02032888|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Interruption or Discontinuation, Treatment-related AEs/SAEs and Grade 3 to 4 AEs/SAEs and Who Died During Treatment Period|AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may or may not have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.|AEs: Day 1 to 7 days after last dose of study treatment (8 weeks or 12 weeks). SAEs: Day 1 to 30 days after last dose of study treatment (8 weeks or 12 weeks)|All participants who received at least 1 dose of study drug.||Participants|||Number
651220|NCT02032888|Secondary|Percentage of Participants With CC or Non-CC Genotype at the IL28B rs12979860 Single Nucleotide Polymorphisms Who Achieved Sustained Virologic Response at Follow-up Week 12 (SVR12)|SVR is defined as hepatitis C virus RNA <lower limit of quantitation, target detected or target not detected at follow-up Week 12. Percentage calculated as number of responders/number of patients receiving treatment.|At Follow-up Week 12|All participants who received at least 1 dose of study drug. n=participants with CC or non-CC Genotype.||Percentage of participants||95% Confidence Interval|Number
651221|NCT02032888|Secondary|Percentage of Participants Coinfected With Hepatitis C Virus/HIV Who Achieved HCV RNA Levels<Lower Limit of Quantitation (LLOQ), Target Not Detected (TND)|Participants with HCV RNA levels <LLOQ, TND. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|At Weeks 1, 2, 4, 6, 8, and 12 and at End of Treatment|All participants who received at least 1 dose of study drug||Percentage of participants||95% Confidence Interval|Number
651222|NCT02032888|Secondary|Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels to be <Lower Limit of Quantitation, Target Detected (TD)or Target Not Detected (TND) at Weeks: 1, 2, 4, 6, 8, and 12; at End of Treatment; and at Follow-up Weeks 4 and 24|Participants with hepatitis C virus CV) levels to be <lower limit of quantitation, TD or TND at each visit. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 1, 2, 4, 6, 8, 12, End of treatment, and follow-up Week 4 and 24|All participants who received at least 1 dose of study drug||Percentage of participants||95% Confidence Interval|Number
651223|NCT02032888|Secondary|Percentage of Participants of All Genotypes Coinfected With Hepatitis C Virus (HCV)/HIV Who Achieved Sustained Virologic Response Rate at Follow-up Week 12 (SVR12)|SVR12 was defined as HCV RNA levels <lower limit of quantitation, target detected or target not detected. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window.|At follow-up Week 12|All participants who received at least 1 dose of study drug.||Percentage of participants||95% Confidence Interval|Number
651224|NCT02032888|Secondary|Percentage of Hepatitis C Virus (HCV)/HIV-coinfected Treatment-experienced Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)|SVR12 was defined as HCV RNA <lower limit of quantitation, target detected or target not detected, at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window.|At follow-up Week 12|All treatment-experienced participants coinfeted with HCV/HIV who received at least 1 dose of study therapy. Here, 'N' signifies the number of participants evaluable for this outcome measure.||Percentage of participants||95% Confidence Interval|Number
651225|NCT02032888|Secondary|Percentage of Hepatitis C Virus (HCV)/HIV-coinfected Treatment-naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)|SVR12 was defined as HCV RNA<lower limit of quantitation, target detected, or target not detected, at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window.|At follow-up Week 12|All treatment-naive participants coinfected with genotype 1 HCV and HIV who received at least 1 dose of study therapy. Here, 'N' signifies the number of participants evaluable for this outcome measure.||Percentage of participants||95% Confidence Interval|Number
651226|NCT02032888|Primary|Percentage of Genotype 1 Hepatitis C Virus (HCV)-Infected Treatment-naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)|SVR12 was defined as HCV RNA <lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window.|At follow-up Week 12|All genotype 1 treatment-naive participants who received at least 1 dose of study therapy. Here, 'number of participants analyzed' (N) signifies the number of participants evaluable for this outcome measure.||Percentage of participants||95% Confidence Interval|Number
651227|NCT02032875|Secondary|Number of Participants With Treatment Emergent Grade 3-4 Laboratory Abnormalities|Grade 3-4 laboratory abnormalities were defined as: Hemoglobin as 6.50–7.4 g/dL for grade 3 and/or < 6.5 g/dL for grade 4, Platelet count as 25*10^9–50*10^9 /L for grade 3 and/or < 25.000*10^9 /L for grade 4, International normalized ratio as 2.1–3.0*upper limit of normal (ULN) > 3.0*ULN for grade 3 and/or > 3.0*ULN for grade 4, Leukocytes as 1.0*10^9–1.5*10^9/L for grade 3 and/or <1.0*10^9/L for grade 4, Lymphocytes (Absolute) as 0.350*109–0.499*10^9 /L for grade 3 and/or < 0.350*10^9 /L for grade 4, Alanine aminotransferase as 5.1–10.0*ULN for grade 3 and/or > 10.0*ULN for grade 4, Aspartate aminotransferase as 5.1–10.0*ULN for grade 3 and/or > 10.0*ULN for grade 4, Alkaline phosphatase as 5.1–10.0*ULN for grade 3 and/or > 10.0*ULN for grade 4, Bilirubin (Total) as 2.6–5.0*ULN for grade 3 and/or > 5.0*ULN for grade 4, Albumin as < 20 g/L, Lipase (Total) as 3.1–5.0*ULN for grade 3 and/or > 5.0*ULN for grade 4, and Creatinine as 1.9–3.4*ULN for grade 3 and/or ≥ 3.5*ULN for grade 4.|From start of study treatment up to 7 days post last dose of study treatment|All treated participants.||participants|||Number
651344|NCT02030535|Secondary|Heart Rate Change From Patient Baseline at Individual Post-dose Time Points|Heart rate change from patient baseline at individual post-dose time points|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)||bpm||Standard Deviation|Mean
651228|NCT02032875|Secondary|Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), AEs Leading to Interruption, Treatment-related AEs/SAEs, Grade 3 to 4 AEs/SAEs, and Death|AE was defined as any new unfavorable symptom, sign, or disease or worsening of a pre-existing condition that does not have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.|From start of study treatment up to 7 days post last dose of study treatment (approximately 13 weeks)|All treated participants.||participants|||Number
651229|NCT02032875|Secondary|Percentage of Participants With CC or Non-CC Genotype Who Achieved Sustained Virologic Response at 12 Weeks After the Last Dose of Study Drug (SVR12)|Participants categorized into 2 genotypes (CC and non-CC) based on single nucleotide polymorphism in the IL28B gene were assessed for SVR12, defined as response in which hepatitis C virus RNA levels be <lower limit of quantitation ie, 25 IU/mL or below target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window.|Post-treatment follow-up Week 12|All treated participants. Here, 'n' signifies participants evaluable for SVR12 at the specified time point in each group, respectively.||Percentage of participants||95% Confidence Interval|Number
651230|NCT02032875|Secondary|Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels Below the Lower Limit of Quantitation Target Not Detected at Each of the Following Weeks: 1, 2, 4, 6, 8, 12, End of Treatment|Participants who responded to treatment were assessed using proportion of subjects with hepatitis C Virus RNA levels below the lower limit of quantitation i.e., 25 IU/mL target not detected, at each on-treatment visit.|Week 1, 2, 4, 6, 8, 12, End of treatment|All treated participants.||Percentage of participants||95% Confidence Interval|Number
651231|NCT02032875|Secondary|Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels Below the Lower Limit of Quantitation Target Detected or Target Not Detected at Each of the Following Weeks: 1, 2, 4, 6, 8, 12, End of Treatment; Follow Up Weeks 4, 8, and 24|Participants who responded to treatment were assessed using proportion of subjects with hepatitis C Virus RNA levels below the lower limit of quantitation i.e., 25 IU/mL target detected or target not detected, at each visit.|Week 1, 2, 4, 6, 8, 12, End of treatment, Follow-up Week 4, 8, and 24|All treated participants.||Percentage of participants||95% Confidence Interval|Number
651232|NCT02032875|Secondary|Percentage of Participants Who Achieved Sustained Virologic Response at Post-treatment Week 12 (SVR12) for All Genotypes and Genotypes 2, 3, 4, 6|SVR12 was defined as hepatitis C Virus (HCV) RNA levels below the lower limit of quantitation i.e., 25 IU/mL target detected or target not detected, at post-treatment Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window.|Post-treatment follow-up Week 12|All treated participants who took at least 1 dose of study medication. Here, ‘n’ signifies participants evaluable for SVR12 at the specified time point in each group, respectively.||Percentage of participants||95% Confidence Interval|Number
651233|NCT02032875|Primary|Percentage of Genotype-1 Infected Cirrhotic Participants With Sustained Virologic Response at Post-treatment Week 12 (SVR12)|SVR12 was defined as hepatitis C Virus (HCV) RNA levels below the lower limit of quantitation i.e., 25 IU/mL target detected or target not detected, at post-treatment Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window.|Post-treatment follow-up Week 12|All genotype 1 cirrhotic participants who received at least 1 dose of study therapy.||Percentage of participants||95% Confidence Interval|Number
651234|NCT02032875|Primary|Percentage of HCV Genotype-1 Infected Post-liver Transplanted Participants With Sustained Virologic Response at Post-treatment Week 12 (SVR12)|SVR12 was defined as hepatitis C Virus (HCV) RNA levels below the lower limit of quantitation (<LLOQ) i.e., 25 IU/mL target detected or target not detected, at post-treatment Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window.|Post-treatment follow-up Week 12|All HCV genotype 1 infected post-transplant participants who received at least 1 dose of study therapy.||Percentage of participants||95% Confidence Interval|Number
651235|NCT02032758|Secondary|Mean Total Putter Face Rotation Before Impact|“Total putter face rotation before impact” is the degrees of rotation of the putter from the start of the forward swing until the time of impact with the golf ball.|baseline, approximately 45 minutes after propranolol dosing|This variable was measured at baseline and then again approximately 45 minutes after propranolol in the group with golfer's cramp on the same day. The pro golfers did not take propranolol so they were only tested once, at baseline.||degrees||Standard Deviation|Mean
651236|NCT02032758|Primary|Mean Dynamic Change of Rotation at Impact|“Dynamic change of rotation at impact” is the velocity of rotation of the putter from the start of the forward swing until the time of impact with the golf ball.|baseline, approximately 45 minutes after propranolol dosing|This variable was measured at baseline and then again approximately 45 minutes after propranolol in the group with golfer's cramp on the same day. The pro golfers did not take propranolol so they were only tested once, at baseline.||degrees/sec||Standard Deviation|Mean
651237|NCT02032706|Secondary|Assess the Accuracy of Night Shift Measurement of Sleep Efficiency|Compare Sleep Efficiency (SE) obtained from PSG and compared to the Night Shift SE to determine if outliers are within the range (19.1 to -17.2%) defined by the predicate device|one night|Studies included 35 baseline comparisons and 30 comparisons at follow-up||% studies|||Number
651238|NCT02032706|Secondary|Assess the Accuracy of Night Shift's Measurement of Total Sleep Time|Compared the Total Sleep Time (TST) from polysomnography to the Night Shift TST to tally the number of records with differences outside the range (151 to -129) defined by the predicate device.|one night|Comparisons included 35 studies at baseline and 30 follow-up studies||% of studies|||Number
651360|NCT02029846|Other Pre-specified|Diabetes Quality of Life|zero|6 months|zero|||||
651361|NCT02029846|Secondary|Overall Hypoglycemia Measured by Glucose Meter|zero|6 months|zero|||||
651240|NCT02032706|Secondary|Evaluate Impact of Positional Therapy on Quality of Life Scores|Compare the Functional Outcomes of Sleep (FOSQ) scores obtained at baseline and compare to results after 4 weeks of therapy to determine the percentage of compliant participants who demonstrate >2 point improvement. The FOSQ includes thirty questions with numerically scaled responses which are totaled with an overall score of 1 identifying the most impaired and 120 identifying the least impaired.|four weeks|||Percentage of participants|||Number
651241|NCT02032706|Secondary|Evaluate Efficacy by Confirming Position Therapy Reduces Daytime Somnolence in Patients With Positional OSA|The percentage of compliant participants who show an improved Epworth Sleepiness Score of >= 2 after 4 weeks of therapy when compared to the baseline score. Epworth scores range from 0 (no daytime somnolence) to 21 being extreme somnolence. A difference of 2 or more indicates some positive benefit from therapy.|baseline and followup|||percentage of participants|||Number
651242|NCT02032706|Secondary|Evaluate Whether Patients Adapt and Sleep Through the Position Therapy Feedback|Evaluate the percent time supine across four weeks of use and confirm that participants average less than 15% time supine across the four weeks of home use|four weeks|||% participants averaged < 15% supine|||Number
651243|NCT02032706|Secondary|Evaluate Whether Night Shift Disrupts Sleep Such That Users Are Non-compliant|Measure the percentage of nights across the 4 weeks of therapy the Night Shift was worn for a minimum of 5.5 hours/night or the length of time in bed by each participant.|four weeks|||Percent of nights||Full Range|Median
651244|NCT02032706|Secondary|Confirmation That Night Shift Accurately Detects Supine Position|Compute the percentage of participants at baseline and at followup in which the Night Shift's measurement of the supine position was within+/- 5% of the percent time supine by video recordings plus chest sensor (gold standard).|baseline and 4-weeks later at follow up|35 subjects completed the baseline polysomnography (PSG) while wearing the device. One subject's PSG study was conducted prior to enrollment but qualified as a baseline. 30 subjects completed a follow-up PSG.||percentage of participants|||Number
651245|NCT02032706|Primary|Evaluate Efficacy Based on a Change in Obstructive Sleep Apnea (OSA) Severity as a Result of Therapy|Determine the percentage of participants that exhibited at least a 50% reduction in OSA severity measured by AHI after 4 weeks of therapy.|30-days|||percentage of participants|||Number
651246|NCT02032706|Primary|Percentage of Participants Who Completed the Study at 4 Weeks Without Adverse Events|Assess the potential for adverse events by evaluating whether more than 20% of participants chose to terminate the study prior to completing 4 weeks of therapy.|Four weeks|||Percentage of participants|||Number
651247|NCT02032641|Secondary|Hair Loss|After each laser session, subjects were asked to rate perceived amount of hair loss from both the treated and control scars on a 1-10 scale, with 1 being none at all and 10 being extremely significant|within 1 hour after final treatment|Within 1 hour after treatment, subjects were given a mirror and asked to rate perceived hair loss for each side on a 1-10 scale, with 1 representing none and 10 representing very significant||units on a scale|BROW|Standard Deviation|Mean
651248|NCT02032641|Secondary|Overall Appearance|Subjects were asked to rate overall cosmesis of both the treated and control scars on a 1-10 scale, with 1 being extremely poor and 10 being extremely excellent, as rated by participant|10 minutes before first treatment and at the final visit|Patients were asked to grade overall cosmesis of both the treated and control scars on a 1-10 scale, with 1 being extremely poor and 10 being extremely excellent. Grading was done 10 minutes prior to each laser treatment and 4 weeks after final treatment||units on a scale|BROW|Standard Deviation|Mean
651249|NCT02032641|Primary|Relative Improvement|Which scar, overall, appears to have improved more from initial to final visit, as rated by blinded examiner of photographs|1 month after final treatment|3 graders masked to treatments were asked to judge side-by-side photographs of first and final visits for which scar improved more. Each pair of before-and-after photos was graded twice by each examiner. Results are percentage of times treated scar was chosen by examiners as most improved (an analysis of 6 results per pair of photos).||percentage of times treated scar chosen|BROW|Standard Deviation|Mean
651250|NCT02032420|Post-Hoc|Inability to Complete Assigned Task at All in Three Attempts|Some participants found the task too difficult to complete.|Immediately after training|||participants|||Number
651251|NCT02032420|Secondary|Performer Fatigue|Self-reported trainee fatigue on a numerical rating scale (1= least fatigued; 10=most fatigued); lower scores indicate less fatigue|During task|||units on a scale||Inter-Quartile Range|Median
651252|NCT02032420|Secondary|Needle-not-seen Time|Median percentage of attempt time on 3 iterations in which the needle is not adequately visualized, across participants within a study arm|During attempt|||percentage of attempt time||Inter-Quartile Range|Median
651253|NCT02032420|Primary|Task Completion Time|Median time taken to complete 3 iterations of the assigned task, across participants within a study arm|Immediately after training|||seconds||Inter-Quartile Range|Median
651254|NCT02032407|Secondary|ASIS Impact Domain Score|The participant assessed the impact of acne vulgaris using the ASIS. The impact domain is a composite of 8 items assessing the psychosocial impacts (6 items emotional and 2 items social) of the 17 items on the overall scale. Each of the items is answered on a 5-point scale: 0 (best) to 4 (worst). The impact domain score is calculated as the average of the 8 items for a total possible score of 0 to 4. Higher scores on the ASIS Impact Domain indicate greater negative impact of acne on health-related quality of life and appearance.|Weeks 2, 6 and 12|Participants from the mITT population, all enrolled participants who received at least one application of study treatment and had at least one post-Baseline efficacy assessment, with data available for analysis at the given time-point.||score on a scale||Standard Deviation|Mean
651255|NCT02032407|Secondary|Acne Symptom and Impact Scale (ASIS) Sign Domain Score|The participant assessed signs of acne vulgaris using the ASIS. The sign domain is a composite of 9 items of the 17 items on the overall scale. Each of the items is answered on a 5-point scale: 0 (best) to 4 (worst). The sign domain score is calculated as the average of the 9 items for a total possible score of 0 to 4. Higher scores indicate the presence of more severe signs of acne.|Weeks 2, 6 and 12|Participants from the mITT population, all enrolled participants who received at least one application of study treatment and had at least one post-Baseline efficacy assessment, with data at the given time-point.||score on a scale||Standard Deviation|Mean
651362|NCT02029846|Primary|Time to Achieve Glycemic Target (HbA1c <7.5%).|Zero|6 months|Zero|||||
651363|NCT02029755|Secondary|Number of Participants With Intervention-related Complication|participants will be followed for the duration of hospital stay|an expected average of 5 days||||||
651256|NCT02032407|Secondary|Percentage of Participants With 0 (None) or 1 (Minimal) on the GAAS|The investigator evaluated the participant’s acne severity using the 5-point GAAS grading scale: 0= No evidence of facial acne vulgaris to 4= Significant degree of inflammatory disease; papules/pustules were a predominant feature; a few nodulo-cystic lesions could have been present; comedones (small pumps on the skin caused by acne) could have been present. The percentage of participants with a score of 0=none or 1=minimal is reported.|Weeks 2, 6 and 12|Participants from the mITT, all enrolled participants who received at least one application of study treatment and had at least one post-Baseline efficacy assessment, with data available at the given time-point.||percentage of participants|||Number
651257|NCT02032407|Secondary|Percent Change From Baseline in Non-Inflammatory Lesion Counts|The investigator evaluated Non-inflammatory (blackhead and whitehead) lesions. A negative percent change from baseline indicates a reduction in lesion counts (improvement).|Baseline, Weeks 2, 6 and 12|Participants from the Modified Intent-to treat (mITT) population, all enrolled participants who received at least one application of study treatment and had at least one post-Baseline efficacy assessment, with data available at the given time-point.||percent change||Standard Deviation|Mean
651258|NCT02032407|Secondary|Percent Change From Baseline in Inflammatory Lesion Counts|The investigator evaluated Inflammatory lesions (papule, pustule and nodule/cyst). A negative percent change from baseline indicates a reduction in lesion counts (improvement).|Baseline, Weeks 2, 6 and 12|Participants from the Modified Intent-to treat (mITT) population, all enrolled participants who received at least one application of study treatment and had at least one post-Baseline efficacy assessment, with data available at the given time-point.||percent change||Standard Deviation|Mean
651259|NCT02032407|Secondary|Percent Change From Baseline in Total Lesion Counts|The investigator evaluated Inflammatory (papule, pustule and nodule/cyst) and Non-inflammatory (blackhead and whitehead) lesions. A papule is a small, red, solid elevation less than 1.0 cm in diameter, a pustule is a small, circumscribed elevation of the skin that contains yellow-white exudate and a nodule/cyst is a circumscribed, elevated, solid lesion generally more than 0.5 cm in diameter with palpable depth. The total lesion count was the sum of the inflammatory and non-inflammatory lesion counts. A negative percent change from baseline indicates a reduction in lesion counts (improvement).|Baseline, Weeks 2, 6 and 12|Participants from the Modified Intent-to treat (mITT) population, all enrolled participants who received at least one application of study treatment and had at least one post-Baseline efficacy assessment, with data available at the given time-point.||percent change||Standard Deviation|Mean
651260|NCT02032407|Secondary|Change From Baseline in the GAAS|The investigator evaluated the participant’s acne severity using the 5-point GAAS grading scale: 0= No evidence of facial acne vulgaris to 4= Significant degree of inflammatory disease; papules/pustules were a predominant feature; a few nodulo-cystic lesions could have been present; comedones (small pumps on the skin caused by acne) could have been present. A negative change from Baseline indicated improvement.|Baseline, Weeks 2 and 6|Modified Intent-to treat (mITT) population included all enrolled participants who received at least one application of study treatment and had at least one post-Baseline efficacy assessment.||score on a scale||Standard Deviation|Mean
651261|NCT02032407|Primary|Change From Baseline in the Global Assessment of Acne Severity (GAAS) Score by Physician|The investigator evaluated the participant’s acne severity using the 5-point GAAS grading scale: 0= No evidence of facial acne vulgaris to 4= Significant degree of inflammatory disease; papules/pustules were a predominant feature; a few nodulo-cystic lesions could have been present; comedones (small pumps on the skin caused by acne) could have been present. A negative change from Baseline indicated improvement.|Baseline, Week 12|Modified Intent-to treat (mITT) population included all enrolled participants who received at least one application of study treatment and had at least one post-Baseline efficacy assessment.||score on a scale||Standard Deviation|Mean
651262|NCT02032238|Primary|Percentage of Eyes That Received Retreatment||12 months|||Percentage of eyes that received retreat|||Number
651263|NCT02032212|Secondary|Nicotine Craving|Craving was assessed with the Brief Questionnaire of Smoking Urges (QSU-Brief). Subject had to rate 10 statements, such as “I have a desire for a cigarette right now”, by a number ranging from 1 (strongly disagree) to 7 (strongly agree). Scores can range from a minimum of 0 to a maximum of 70. A higher score means a stronger urge to smoke a cigarette.|30 minutes after the third product use|||score on a scale||Standard Deviation|Mean
651264|NCT02032212|Secondary|Nicotine Withdrawal Symptoms|Withdrawal symptoms were evaluated with the Minnesota Nicotine Withdrawal Scale questionnaire, to which only the 15 questions of the subject’s part were completed. Subjects had to rate behaviours (e.g. angry, irritable, frustrated, depressed, restless, insomnia) from 0 (none) to 4 (severe). A higher score means more severe withdrawal symptoms. Scores range from a minimum of 0 to a maximum of 60.|30 minutes after the third product use|||score on a scale||Standard Deviation|Mean
651265|NCT02032212|Secondary|Exhaled Carbon Monoxide|Measured with a Smokerlyser device|25 minutes|||ppm||Standard Deviation|Mean
651266|NCT02032212|Primary|Area Under the Concentration-time Curve for Plasma Nicotine (AUCt)||1, 2, 3, 4, 5, 6, 7, 8, 10, 13, 15, 30, 45, 60 minutes, 2, 4, 6, 8, 12 and 21 hours|||min*ng/ml||Geometric Coefficient of Variation|Geometric Mean
651267|NCT02032212|Primary|Nicotine Plasma Concentration|Maximum plasma nicotine concentration (Cmax)|1, 2, 3, 4, 5, 6, 7, 8, 10, 13, 15, 30, 45, 60 minutes, 2, 4, 6, 8, 12 and 21 hours|||ng/ml||Geometric Coefficient of Variation|Geometric Mean
651268|NCT02031679|Secondary|The Ability of AZD1981 to Inhibit Prostaglandin D2 (PGD2)-Induced Eosinophil Shape|The measure of Eosinophil shape change was assessed by cell scatter characteristics using a flow cytometer. Cellular scatter was established with buffer and then several doses of PGD2 stimulation.|Baseline, End of treatment, end of washout|Insufficient samples were obtained for one active and 2 placebo patients.||Mean fluorescence units area under curve||Standard Deviation|Mean
651269|NCT02031679|Secondary|The Number of Participants With Adverse Events|The safety of AZD1981 will be assessed using the following outcome measures: incidence and severity of treatment-emergent adverse events and serious adverse events, clinical laboratory measures, and vital signs. In particular we will measure CBC’s with differential at baseline and week 4 and liver function tests every 2 weeks based on past trial experience of dose-related toxicity.|8 weeks|||participants with adverse events|||Number
651364|NCT02029755|Secondary|Length of Hospital Stay|participants will be followed for the duration of hospital stay|an expected average of 5 days||||||
651365|NCT02029755|Secondary|Time to Flatus|participants will be followed for the duration of hospital stay|an expected average of 5 days||||||
651270|NCT02031679|Primary|The Change in Diary-based Clinical Symptoms as Measured by the Urticaria Activity Score 7 (UAS7)|The UAS score, which is the sum of pruritus and hives, will be used to calculate the UAS7. UAS is a validated measure of Chronic Spontaneous Urticaria (CSU) disease activity which scores the intensity of pruritus (0–3, with 0 = no itch and 3 is severe itch) and number of hives (0–3 0 means no hives and 3 means greater than 50 hives) with a maximum value of 6 for a given day. The UAS7 is the sum of the daily average UAS scores (average of a.m. and p.m.) for 7 days with a minimum score of 0 and a maximum value of 42. The UAS7 is a sum of the daily average (average of a.m. and p.m.) for 7 days. The baseline score was established during the second placebo therapy week and compared to the final week of the 4 week active treatment period.|7 Days|One placebo subject had diary data compromised by device malfunction so only full data for 11 subjects were analyzed||UAS7 Scores||Standard Error|Mean
651271|NCT02031471|Secondary|Safety: Percentage of Participants With Anti-tocilizumab Antibodies||Baseline, Week 24|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here, n is the number of participants with evaluable data for this outcome measure.||percentage of participants|||Number
651272|NCT02031471|Secondary|Safety: Percentage of Participants With Adverse Events|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|Up to 52 weeks|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab.||percentage of participants|||Number
651273|NCT02031471|Secondary|Treatment Satisfaction Questionnaire for Medication (TSQM ) Scores|The abbreviated 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) derived from the TSQM Version 1.4 but without the five items of the side effects domain, is a reliable and valid measure to assess participants’ satisfaction with treatment. The TSQM-9 domain scores range from 0 to 100 with higher scores representing higher satisfaction on that domain. Domains included are effectiveness, convenience and global satisfaction.|Week 24|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.||Units on a scale||Standard Deviation|Mean
651274|NCT02031471|Secondary|Change From Baseline in Work Instability Scale for Rheumatoid Arthritis (RA-WIS)|The 23-item RA-WIS is a simple, validated screening tool for work instability, i.e., the consequences of a mismatch between an individual’s functional ability and their work tasks. This self-administered questionnaire covers a broad range of specific work-related issues and enables monitoring the risk of work disability in rheumatoid arthritis patients. The RA-WIS is scored by summing responses from all 23 scale items. The scale ranges from 0 to 23. Cut points have been established to differentiate levels of work instability: low < 10, moderate 10-17 and high > 17. A negative change from baseline indicates an improvement.|From Baseline to Week 24|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.||Units on a scale||Standard Deviation|Mean
651275|NCT02031471|Secondary|Change From Baseline in Patient Satisfaction VAS|The Patient Satisfaction VAS assessment represents the participant’s assessment of his/her current satisfaction with treatment on a 100 mm horizontal VAS. The extreme left end of the line represents 0=“no satisfaction” and the extreme right end 100=“extremely satisfied”. A positive change from baseline indicates an improvement.|From Baseline to Week 2, Week 24 and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.||Units on a scale||Standard Deviation|Mean
651276|NCT02031471|Secondary|Change From Baseline in Patient Fatigue VAS|The Patient Fatigue VAS assessment represents the participant’s assessment of his/her current level of fatigue on a 100 mm horizontal VAS. The extreme left end of the line represents 0=“no fatigue” and the extreme right end 100=“extreme fatigue”. A negative change from baseline indicates an improvement.|From Baseline to Week 2, Week 24 and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.||Units on a scale||Standard Deviation|Mean
651277|NCT02031471|Secondary|Change From Baseline in Arthritis Impact Measurement Scale-Short Form (AIMS-SF)|The AIMS-SF is a reduced version of the validated AIMS2 questionnaire. The Short Form has been developed using a comprehensive expert-based approach and supported by psychometric testing. The AIMS-SF is a self-administered questionnaire to measure changes in global health, pain, mobility and social function in adult patients with arthritis and reports scores for physical, symptoms, affect, social and work assessments. Scores range from 0 to 10, higher scores indicating higher impact of arthritis on the assessments. A negative change from baseline indicates an improvement.|From Baseline to Week 4, Week 24 and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here, n is the number of participants with evaluable data for this outcome measure.||Units on a scale||Standard Deviation|Mean
651278|NCT02031471|Secondary|Change From Baseline in Patient Quality of Sleep VAS|The Patient Quality of Sleep VAS assessment represents the participant’s assessment of his/her current quality of sleep on a 100 mm horizontal VAS. The extreme left end of the line represents 0=“no difficulty to sleep” and the extreme right end 100=“extreme sleeping difficulties”. A negative change from baseline indicates an improvement.|From Baseline to Week 2, Week 24 and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.||Units on a scale||Standard Deviation|Mean
651337|NCT02030535|Secondary|Mean QTcB (Heart Rate Corrected QT Interval (Using Bazett Adjustment)) Change From Patient Baseline Over All Post-dose Time Points|Mean QTcB (Heart Rate Corrected QT Interval (Using Bazett Adjustment))change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)||ms||Standard Deviation|Mean
651366|NCT02029755|Secondary|Heart Rate Variability||preoperative, postoperative 1 hour and 1 day||||||
651367|NCT02029755|Secondary|Quality of Recovery 40||postoperative 48 hour||||||
651279|NCT02031471|Secondary|Change From Baseline in Pittsburgh Sleep Quality Index (PSQI)|The PSQI is a self-rated questionnaire which assesses sleep quality and disturbances over 1-month time interval. Nineteen individual items generate seven “component” scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The participant self-rates each of these seven areas of sleep. Scoring of answers is based on a 0 to 3 scale, whereby 3 reflects the negative extreme on the Likert Scale. Global scores range from 0 to 21 and a global sum of “5” or greater indicates a “poor” sleeper. Although there are several questions that request the evaluation of the participant’s bed mate or roommate, these are not scored. A negative change from baseline indicates an improvement.|From Baseline to Week 4, Week 24 and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.||Units on a scale||Standard Deviation|Mean
651280|NCT02031471|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)|The symptom-specific measure FACIT-F was developed to assess chronic illness therapy with special emphasis on fatigue in the past 7 days. In this study, only the FACIT-F short questionnaire, which is a shorter version of the initial FACIT-F questionnaire, was used. Each of the questions is categorically answered using the scales 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much. The figures are reversed during score calculations, so that higher score values indicate more favorable conditions. The 13 items included in the FACIT-F short can be used to calculate the brief score for FACIT-F scale (score range: 0-52). A positive change from baseline indicates an improvement.|From Baseline to Week 2, Week 24 and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.||Units on a scale||Standard Deviation|Mean
651281|NCT02031471|Secondary|Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)|The Stanford HAQ-DI is a patient-oriented outcome assessment questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other common activities. Each category contains multiple questions, which were answered using a 4-point scale from 0 to 3. The overall index score was an average of the individual item responses and may range from 0 to 3, where higher scores indicate more difficulty in daily living activities. A negative change from baseline indicates an improvement.|From Baseline to Week 2, Week 24 and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.||Units on a scale||Standard Deviation|Mean
651282|NCT02031471|Secondary|Acute Phase Reactants: Change From Baseline in ESR|A negative change from baseline in ESR indicates an improvement.|From Baseline to Week 2, Week 24 and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.||millimeters per hour (mm/hr)||Standard Deviation|Mean
651283|NCT02031471|Secondary|Acute Phase Reactants: Change From Baseline in CRP|A negative change from baseline in CRP level indicates an improvement.|From Baseline to Week 2, Week 24 and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.||milligrams per liter (mg/L)||Standard Deviation|Mean
651284|NCT02031471|Secondary|Change From Baseline in Patient’s Assessment of Pain VAS|Patient’s Assessment of Pain VAS represents the participant’s assessment of his/her current level of pain on a 100 mm horizontal VAS. The extreme left end of the line represents 0=“no pain” and the extreme right end 100=“unbearable pain”. A negative change from baseline indicates an improvement.|From Baseline to Week 2 and Week 24|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.||Units on a scale||Standard Deviation|Mean
651285|NCT02031471|Secondary|Change From Baseline in Patient’s Global Assessment of Disease Activity VAS|PGA VAS represents the participant’s overall assessment of their current disease activity on a 100 mm horizontal VAS. The extreme left end of the line represents 0= “no disease activity” (symptom-free and no arthritis symptoms) and the extreme right end 100=“maximum disease activity” (maximum arthritis disease activity). A negative change from baseline indicates an improvement.|From Baseline to Week 2, Week 24 and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.||Units on a scale||Standard Deviation|Mean
651286|NCT02031471|Secondary|Change From Baseline in Physician’s Global Assessment of Disease Activity VAS|Physician’s Global Assessment of disease activity VAS represents the physician’s assessment of the participant’s current disease activity on a 100 mm horizontal VAS. The extreme left end of the line represents 0= “no disease activity” (symptom-free and no arthritis symptoms) and the extreme right end 100= “maximum disease activity”. This was completed by the Treating Physician (or designee). A negative change from baseline indicates an improvement.|From Baseline to Week 2, Week 24 and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.||Units on a scale||Standard Deviation|Mean
651287|NCT02031471|Secondary|Percentage of Participants Achieving a Clinically Significant Improvement in DAS28|The DAS28 score is a measure of the participant’s disease activity calculated using TJC28, SJC28, PGA VAS with 0=no disease activity to 100=maximum disease activity displayed on the 100-millimeter (mm) horizontal VAS and acute phase reactant (erythrocyte sedimentation rate [ESR] or C-reactive protein [CRP]) for a total possible score of 0 to 10. For this study ESR was used to calculate the DAS28 score. The index is calculated using the following formula: DAS28 = (0.56*√[TJC28]) + (0.28*√[SJC28]) + (0.70*ln[ESR]) + (0.014*VAS). Higher scores represent higher disease activity. DAS28 Clinically Significant Improvement was defined as a DAS28 score reduction of at least 1.2 units from Baseline.|From Baseline to Week 2, Week 24 and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here, n is the number of participants with evaluable data for this outcome measure.||percentage of participants|||Number
651368|NCT02029755|Secondary|Pruritus||postoperative 1, 6, 24, 48 hour||||||
651288|NCT02031471|Secondary|Percentage of Participants Achieving DAS28-ESR Remission, DAS28-ESR LDA, Moderate Disease Activity and High Disease Activity|The DAS28 score is a measure of the participant’s disease activity calculated using TJC28, SJC28, PGA VAS with 0=no disease activity to 100=maximum disease activity displayed on the 100-millimeter (mm) horizontal VAS and acute phase reactant (erythrocyte sedimentation rate [ESR] or C-reactive protein [CRP]) for a total possible score of 0 to 10. For this study ESR was used to calculate the DAS28 score. The index is calculated using the following formula: DAS28 = (0.56*√[TJC28]) + (0.28*√[SJC28]) + (0.70*ln[ESR]) + (0.014*VAS). Higher scores represent higher disease activity. Clinical remission = score <2.6; Low disease activity = score ≥2.6 and ≤3.2; Moderate disease activity = score > 3.2 and ≤5.1; High disease activity = score >5.1.|From Baseline to Week 2, Week 24 and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here, n is the number of participants with evaluable data for this outcome measure.||percentage of participants|||Number
651289|NCT02031471|Secondary|Percentage of Participants Achieving SDAI Remission, SDAI LDA, Moderate Disease Activity and High Disease Activity|SDAI is calculated by simple arithmetical addition of TJC28 and SJC28, PGA VAS and Physician Global Assessment of disease activity VAS, and CRP concentration in mg/L. VAS range was 0=no disease activity to 100=maximum disease activity displayed on the 100-mm horizontal VAS. Total SDAI score ranges from 0 to 86 with higher scores indicating increased disease activity. Clinical remission = score ≤ 3.3; Low disease activity = score > 3.3 and ≤ 11.0; Moderate disease activity = score > 11.0 and ≤ 26.0; high disease activity = score > 26.0.|From Baseline to Week 2, Week 24 and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here, n is the number of participants with evaluable data for this outcome measure.||percentage of participants|||Number
651290|NCT02031471|Secondary|Percentage of Participants Achieving CDAI Remission, CDAI Low Disease Activity, Moderate Disease Activity and High Disease Activity|CDAI is calculated by simple arithmetical addition of TJC28 and SJC28, PGA VAS and Physician Global Assessment of disease activity VAS. VAS range was 0=no disease activity to 100=maximum disease activity displayed on the 100-mm horizontal VAS. Total CDAI score ranges from 0 to 76 with higher scores indicating increased disease activity. Clinical remission = score ≤ 2.8; Low disease activity = score > 2.8 and ≤ 10.0; Moderate disease activity = score > 10.0 and ≤ 22.0; High disease activity = score > 22.0.|Baseline to Week 2, Week 24 and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here, n is the number of participants with evaluable data for this outcome measure.||percentage of participants|||Number
651291|NCT02031471|Secondary|Percentage of Participants With Corticosteroid Dose Reduction/Discontinuation||Up to Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure.||percentage of participants|||Number
651292|NCT02031471|Secondary|Change in Total Tender/Swollen Joint Counts (TJC/SJC)|An assessment of 66 joints for swelling and 68 joints for tenderness was made. Joints were assessed and classified as swollen/not swollen and tender/not tender by pressure and joint manipulation on physical examination. Joint prosthesis, arthrodesis or fused joints were not taken into consideration for swelling or tenderness. A negative change from baseline indicates an improvement.|From Baseline to Week 2, Week 24 and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here, n is the number of participants with evaluable data for this outcome measure||Joint Counts||Standard Deviation|Mean
651293|NCT02031471|Secondary|Change From Baseline in Simplified Disease Activity Index (SDAI)/Clinical Disease Activity Index (CDAI)|SDAI is a similar index to DAS28 but has the advantage of not needing a complicated mathematical formula for its determination, but a simple arithmetical addition of TJC28 and SJC28, PGA VAS and Physician Global Assessment of disease activity VAS, and CRP concentration in mg/L. CDAI does not incorporate an acute response, therefore it can be used to evaluate disease activity in the absence of laboratory testing of CRP and ESR. VAS range for all assessments was 0=no disease activity to 100=maximum disease activity displayed on the 100-mm horizontal VAS. SDAI scores ranged from 0 to 86, CDAI from 0 to 76 with higher scores indicating increased disease activity. A negative change from baseline indicates an improvement.|From Baseline to Week 2, Week 24 and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.||Units on a scale||Standard Deviation|Mean
651294|NCT02031471|Secondary|Percentage of Participants With Responses According to European League Against Rheumatism (EULAR ) Criteria|EULAR response was calculated as the difference between DAS28-ESR scores at baseline and Week 24, and reported as the percentage of participants with good, moderate, or no response. Good responders = decrease from baseline >1.2 with a DAS28 score of <=3.2; moderate responders = decrease from baseline >1.2 with a DAS28 score of >3.2, or decrease from baseline >0.6 to <=1.2 with a DAS28 score of <=5.1; non-responders = decrease from baseline <=0.6 or decrease from baseline >0.6 and <=1.2 with a DAS28 score of >5.1.|From Baseline to Week 2, Week 24|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.||percentage of participants|||Number
651295|NCT02031471|Secondary|Percentage of Participants With Positive American College of Rheumatology (ACR) Response Scores|The ACR core set of outcome measures and their definition of improvement includes a >= 20% improvement (ACR20) compared to Baseline in both SJC and TJC as well as in three out of five additional parameters: Physician’s Global Assessment of disease activity VAS, PGA VAS, patient’s assessment of pain VAS, Health Assessment Questionnaire-Disability Index (HAQ-DI), and acute phase reactant (CRP or ESR). VAS range for all assessments was 0=no disease activity to 100=maximum disease activity displayed on the 100-mm horizontal VAS. Achievement of an ACR50 requires a >= 50% improvement in the same parameters and an ACR70 requires a >= 70% improvement.|From Baseline to Week 2, Week 24, and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here, n is the number of participants with evaluable data for this outcome measure.||percentage of participants|||Number
651338|NCT02030535|Secondary|QT Change From Patient Baseline at Individual Post-dose Time Points|QT change from patient baseline at individual post-dose time points|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)||ms||Standard Deviation|Mean
651296|NCT02031471|Primary|Change From Baseline in Disease Activity Score 28 - Erythrocyte Sedimentation Rate (DAS28-ESR) Score in the Per Protocol Set (PPS)|The DAS28 score is a measure of the participant’s disease activity calculated using the TJC28, SJC28, PGA VAS with 0=no disease activity to 100=maximum disease activity displayed on the 100-mm horizontal VAS and acute phase reactant (ESR or CRP) for a total possible score of 0 to 10. For this study ESR was used to calculate the DAS28 score. The index is calculated using the following formula: DAS28 = (0.56*√[TJC28]) + (0.28*√[SJC28]) + (0.70*ln[ESR]) + (0.014*VAS). Higher scores represent higher disease activity. A negative change from baseline indicates an improvement.|From baseline to Week 24|The PPS consisted of all participants of the FAS having a value at baseline and at Week 24 for the endpoint DAS28-ESR, excluding sponsor defined deviation(s) which could have affected the evaluation of the primary endpoint (DAS28-ESR). Here, n is the number of participants with evaluable data for this outcome measure.||Units on a scale||Standard Deviation|Mean
651297|NCT02031471|Primary|Change From Baseline in Disease Activity Score 28 - Erythrocyte Sedimentation Rate (DAS28-ESR) Score in the Full Analysis Set (FAS)|The DAS28 score is a measure of the participant’s disease activity calculated using the tender joint count of 28 joints (TJC28), swollen joint count of 28 joints (SJC28), patient’s global assessment of disease activity visual analog scale (PGA VAS) with 0=no disease activity to 100=maximum disease activity displayed on the 100-millimeter (mm) horizontal VAS and acute phase reactant (erythrocyte sedimentation rate [ESR] or C-reactive protein [CRP]) for a total possible score of 0 to 10. For this study ESR was used to calculate the DAS28 score. The index is calculated using the following formula: DAS28 = (0.56*√[TJC28]) + (0.28*√[SJC28]) + (0.70*ln[ESR]) + (0.014*VAS). Higher scores represent higher disease activity. A negative change from baseline indicates an improvement.|From baseline to Week 24|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.||Units on a scale||Standard Deviation|Mean
651298|NCT02031458|Secondary|Percentage of Participants With Event (Disease Progression or Death) as Assessed by INV Per Modified RECIST v1.1|PD was defined as at least 20% increase from nadir in the sum of diameters of new and/or existing target lesions (with an absolute increase of at least 5 mm).|Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)|Efficacy evaluable population; n = number of participants analyzed at the specified time point.||percentage of participants|||Number
651299|NCT02031458|Secondary|Percentage of Participants With Event (Disease Progression or Death) as Assessed by INV Per RECIST v1.1|PD was defined as one or more of the following: at least 20% increase from nadir in the sum of diameters of target lesions (with an absolute increase of at least 5 mm), appearance of new lesions, and/or unequivocal progression of non-target lesions.|Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)|Efficacy evaluable population; n = number of participants analyzed at the specified time point.||percentage of participants|||Number
651300|NCT02031458|Secondary|Percentage of Participants With Event (Disease Progression or Death) as Assessed by IRF Per RECIST v1.1|PD was defined as one or more of the following: at least 20% increase from nadir in the sum of diameters of target lesions (with an absolute increase of at least 5 mm), appearance of new lesions, and/or unequivocal progression of non-target lesions.|Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)|Efficacy evaluable population; n = number of participants analyzed at the specified time point.||percentage of participants|||Number
651301|NCT02031458|Secondary|Percentage of Participants With Positive Anti-Therapeutic Antibody (Anti-Atezolizumab Antibody) Status|Anti-therapeutic antibodies is a measurement to explore the potential relationship of immunogenicity response with pharmacokinetics, safety and efficacy.|Baseline, post-baseline (up to 16 months)|Efficacy evaluable population; n = number of participants analyzed at the specified time point. Number of participants analyzed = number participants who were evaluable for this outcome.||percentage of participants|||Number
651302|NCT02031458|Secondary|Atezolizumab Serum Concentrations|Serum concentrations were determined for all participants after administration of atezolizumab up to Cycle 8. Time (T) = time from first dose in days.|Pre-dose (hour 0) and 0.5 hours post dose on Cycle 1 Day 1 (Cycle length = 21days), Cycle 1 Days 2, 4, 8, 15, and 21, Cycle 2 Day 21, Cycle 3 Day 21, Cycle 7 Day 21|Pharmacokinetic evaluable population; n = number of participants analyzed for the specified time point.||micrograms per milliliter (μg/mL)||Standard Deviation|Mean
651303|NCT02031458|Secondary|TIR as Assessed by IRF Per RECIST v1.1|TIR is interval between date of first occurrence of a CR or PR that is subsequently confirmed (whichever status is recorded first) and first date that PD or death is documented, whichever occurs first as measured by RECIST v1.1. For responders, TIR was the same as DOR; for non-responders, TIR was considered as an event and defined as the date of first treatment plus one day. TIR was assessed by Kaplan-Meier estimates.|Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)|Efficacy evaluable population||months||95% Confidence Interval|Median
651304|NCT02031458|Secondary|TIR as Assessed by INV Per Modified RECIST|TIR is interval between date of first occurrence of a CR or PR that is subsequently confirmed (whichever status is recorded first) and first date that PD or death is documented, whichever occurs first as measured by modified RECIST. For responders, TIR was the same as DOR; for non-responders, TIR was considered as an event and defined as the date of first treatment plus one day. TIR was assessed by Kaplan-Meier estimates.|Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)|Efficacy evaluable population||months||95% Confidence Interval|Median
651339|NCT02030535|Secondary|Peak QT (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points|Peak QT change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)||ms||Standard Deviation|Mean
651369|NCT02029755|Secondary|Time to the First Request of Analgesics|participants will be followed for the duration of hospital stay|an expected average of 5 days||||||
651305|NCT02031458|Secondary|Time in Response (TIR) as Assessed by INV Per RECIST v1.1|TIR is interval between date of first occurrence of a CR or PR that is subsequently confirmed (whichever status is recorded first) and first date that PD or death is documented, whichever occurs first as measured by RECIST v1.1. For responders, TIR was the same as DOR; for non-responders, TIR was considered as an event and defined as the date of first treatment plus one day. TIR was assessed by Kaplan-Meier estimates.|Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)|Efficacy evaluable population||months||95% Confidence Interval|Median
651306|NCT02031458|Secondary|PFS: Percentage of Participants Alive and Progression Free at 12 Months|PD is defined as one or more of the following: at least 20% increase from nadir in the sum of diameters of target lesions (with an absolute increase of at least 5mm), appearance of new lesions, and/or unequivocal progression of non-target lesions.|Month 12|Efficacy evaluable population; n = number of participants analyzed within the specified group.||percentage of participants||95% Confidence Interval|Number
651307|NCT02031458|Secondary|PFS: Percentage of Participants Alive and Progression Free at 6 Months|PD is defined as one or more of the following: at least 20% increase from nadir in the sum of diameters of target lesions (with an absolute increase of at least 5mm), appearance of new lesions, and/or unequivocal progression of non-target lesions.|Month 6|Efficacy evaluable population; n = number of participants analyzed within the specified group.||percentage of participants||95% Confidence Interval|Number
651308|NCT02031458|Secondary|Percentage of Participants Without an Event (Death) at 12 Months||Month 12|Efficacy evaluable population; n = number of participants analyzed within the specified group.||percentage of participants||95% Confidence Interval|Number
651309|NCT02031458|Secondary|Percentage of Participants Without an Event (Death) at 6 Months||Month 6|Efficacy evaluable population; n = number of participants analyzed within the specified group.||percentage of participants||95% Confidence Interval|Number
651310|NCT02031458|Secondary|Overall Survival : Median Time to Event (Death)|Overall survival is measured as interval between the first dose of atezolizumab and date of death from any cause.|Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)|Efficacy evaluable population; n = number of participants analyzed within the specified group.||months||95% Confidence Interval|Median
651311|NCT02031458|Secondary|Overall Survival : Percentage of Participants Without Event (Death)||Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)|Efficacy evaluable population; n = number of participants analyzed within the specified group.||percentage of participants|||Number
651312|NCT02031458|Secondary|PFS as Assessed by INV Per Modified RECIST|PFS is the interval between the first dose of atezolizumab and date of disease progression or death due to any cause, whichever occurred first as measured by modified RECIST. PD: at least 20% increase from nadir in the sum of diameters of new and/or existing target lesions (with an absolute increase of at least 5mm). PFS was assessed by Kaplan-Meier estimates.|Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)|Efficacy evaluable population; n = number of participants analyzed within the specified group.||months||95% Confidence Interval|Median
651313|NCT02031458|Secondary|PFS as Assessed by INV Per RECIST v1.1|PFS is the interval between the first dose of atezolizumab and date of disease progression or death due to any cause, whichever occurred first as measured by RECIST v1.1. PD: one or more of the following: at least 20% increase from nadir in the sum of diameters of target lesions (with an absolute increase of at least 5mm), appearance of new lesions, and/or unequivocal progression of non-target lesions. PFS was assessed by Kaplan-Meier estimates.|Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)|Efficacy evaluable population; n = number of participants analyzed within the specified group.||months||95% Confidence Interval|Median
651314|NCT02031458|Secondary|Progression Free Survival (PFS) as Assessed by IRF Per RECIST v1.1|PFS is the interval between the first dose of atezolizumab and date of disease progression or death due to any cause, whichever occurred first as measured by RECIST v1.1. PD is defined as one or more of the following: at least 20% increase from nadir in the sum of diameters of target lesions (with an absolute increase of at least 5mm), appearance of new lesions, and/or unequivocal progression of non-target lesions. PFS was assessed by Kaplan-Meier estimates.|Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)|Efficacy evaluable population; n = number of participants analyzed within the specified group.||months||95% Confidence Interval|Median
651315|NCT02031458|Secondary|DOR as Assessed by INV Per Modified RECIST|DOR is the interval between the date of the first occurrence of a CR or PR that is subsequently confirmed (whichever status is recorded first) and the first date that PD or death is documented, whichever occurs first as measured by modified RECIST. CR: disappearance of all target lesions. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10mm; PR: at least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR; PD: one or more of the following: at least 20% increase from nadir in the sum of diameters of existing and/or new target lesions (with an absolute increase of at least 5mm). DOR was assessed by Kaplan-Meier estimates. Results were reported by line of therapy (reporting arms) and PD-L1 Expression Subgroup (TC3 or IC3, TC3 or IC2/3, TC2/3 or IC2/3).|Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)|Efficacy evaluable population; n = number of participants analyzed within the specified group. Number of participants analyzed = overall number of participants who were evaluable for this outcome||months||95% Confidence Interval|Median
651340|NCT02030535|Secondary|Mean QT (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points|Mean QT change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)||ms||Standard Deviation|Mean
651316|NCT02031458|Secondary|DOR as Assessed by INV Per RECIST v1.1|DOR is interval between date of the first occurrence of a CR or PR that is subsequently confirmed (whichever status is recorded first) and first date that PD or death is documented, whichever occurs first as measured by RECIST v1.1. CR: disappearance of all target and non-target lesions. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10mm; PR: > or = 30 % decrease from baseline in sum of diameters of target lesions, non-PD non-target lesions and no new lesions; PD: one or more of the following: at least 20% increase from nadir in sum of diameters of target lesions (with an absolute increase of at least 5mm), appearance of new lesions, and/or unequivocal progression of non-target lesions. DOR was assessed by Kaplan-Meier estimates. Results were reported by line of therapy (reporting arms) and PD-L1 Expression Subgroup (TC3 or IC3, TC3 or IC2/3, TC2/3 or IC2/3).|Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)|Efficacy evaluable population; n = number of participants analyzed within the specified group. Number of participants analyzed = overall number of participants who were evaluable for this outcome.||months||95% Confidence Interval|Median
651317|NCT02031458|Secondary|Duration of Response (DOR) Assessed by IRF Per RECIST v1.1|DOR is interval between date of first occurrence of a CR or PR that is subsequently confirmed (whichever status is recorded first) and the first date that PD or death is documented, whichever occurs first as measured by RECIST v1.1. CR: disappearance of all target and non-target lesions. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10mm; PR: > or = 30 % decrease from baseline in sum of diameters of target lesions, non-PD non-target lesions and no new lesions; PD: one or more of the following: at least 20% increase from nadir in sum of diameters of target lesions (with an absolute increase of at least 5mm), appearance of new lesions, and/or unequivocal progression of non-target lesions. DOR was assessed by Kaplan-Meier estimates. Results were reported by line of therapy (reporting arms) and PD-L1 Expression Subgroup (TC3 or IC3, TC3 or IC2/3, TC2/3 or IC2/3).|Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)|Efficacy evaluable population; n = number of participants analyzed within the specified group. Number of participants analyzed = overall number of participants who were evaluable for this outcome.||months||95% Confidence Interval|Median
651318|NCT02031458|Secondary|Percentage of Participants Achieving Objective Response Per Modified RECIST as Assessed by the INV|ORR was the percentage of participants whose confirmed best overall response was either a PR or a CR based upon the Investigator assessment per modified RECIST. CR: disappearance of all target lesions. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10mm; PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR. Results were reported by line of therapy (reporting arms) and PD-L1 Expression Subgroup (TC3 or IC3, TC3 or IC2/3, TC2/3 or IC2/3).|Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)|Efficacy evaluable population; n= number of participants analyzed within the specified group.||percentage of participants||95% Confidence Interval|Number
651319|NCT02031458|Secondary|Percentage of Participants Achieving Objective Response Per RECIST v1.1 as Assessed by the Investigator (INV)|ORR was the percentage of participants whose confirmed best overall response was either a PR or a CR based upon the Investigator assessment per RECIST v1.1. CR: disappearance of all target and non-target lesions. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10mm; PR: > or = 30 % decrease from baseline in sum of diameters of target lesions, non-PD non-target lesions and no new lesions. Results were reported by line of therapy (reporting arms) and PD-L1 Expression Subgroup (TC3 or IC3, TC3 or IC2/3, TC2/3 or IC2/3).|Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)|Efficacy evaluable population; n = number of participants analyzed within the specified group.||percentage of participants||95% Confidence Interval|Number
651320|NCT02031458|Primary|Percentage of Participants Achieving Objective Response (ORR) Per Response Evaluation Criteria In Solid Tumors (RECIST) Version (v) 1.1 as Assessed by Independent Review Facility (IRF)|ORR was the percentage of participants whose confirmed best overall response was either a Partial Response (PR) or a Complete Response (CR) based upon the IRF assessment per RECIST v1.1. CR: disappearance of all target and non-target lesions. Any pathological lymph nodes (target or non-target) must have reduction in short axis to less than (<) 10 millimeters (mm); PR:greater than (>) or equal to (=) 30 percent (%) decrease from baseline in sum of diameters of target lesions, non-progressive disease (PD) non-target lesions and no new lesions. Results were reported by line of therapy and programmed death-ligand 1 (PD-L1) Expression Subgroup (tumor cell [TC]3 [TC3] or tumor-infiltrating immune cell [IC] 3 [IC3], TC3 or IC2/3, TC2/3 or IC2/3).|Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)|Efficacy evaluable population; Number (n) equals (=) number of participants analyzed within the specified group.||percentage of participants||95% Confidence Interval|Number
651321|NCT02030600|Secondary|FPG (Fasting Plasma Glucose)|Fasting plasma glucose values at week 32 and week 64.|week 32, week 64|Full analysis set. Here, 'n' specifies the number of subjects with available data at specified timepoint.||mg/dL||Standard Deviation|Mean
651322|NCT02030600|Secondary|Change From Baseline in HbA1c (Glycosylated Haemoglobin)|Change from baseline in HbA1c (glycosylated haemoglobin) at week 32 (treatment period 1) and at week 64 (treatment period 2). Week 32 HbA1c value was considered as baseline for calculating change from baseline in HbA1c at week 64.|Week 32, Week 64|Full analysis set. Here, 'n' specifies the number of subjects with available data at specified timepoint.||percentage of glycosylated haemoglobin||Standard Deviation|Mean
651323|NCT02030600|Secondary|Incidence of Treatment Emergent Adverse Events|Treatment emergent adverse event was defined as an event with onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.|During 32 weeks of treatment for each treatment period|Safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator (Total number of subjects analysed for this endpoint: 713).||events|||Number
651324|NCT02030600|Secondary|Proportion of Subjects With One or More Severe Hypoglycaemic Episodes During the Maintenance Period|Percentage of subjects who experienced one or more severe hypoglycaemic episodes during the maintenance period. Severe hypoglycaemia (according to the American Diabetes Association 2013 definition): A hypoglycaemic episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose values may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration.|After 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64)|The trial followed a cross over design. Descriptive analysis was based on the safety analysis set. Number of subjects analysed=subjects with available data for the endpoint as per individual trial products. Statistical analysis was performed on subjects in full analysis set with exposure in both maintenance periods.||percentage of subjects|||Number
651325|NCT02030600|Secondary|Number of Treatment Emergent Severe or BG Confirmed Symptomatic Nocturnal Hypoglycaemic Episode During the Maintenance Period|Severe or BG confirmed symptomatic nocturnal hypoglycaemic episodes were defined as episodes that were severe and/or BG confirmed by a plasma glucose value of <56 mg/dL (3.1 mmol/L), with symptoms consistent with hypoglycaemia and with time of onset between 00:01 and 05.59 a.m., both inclusive. Treatment emergent hypoglycaemic episode was defined as an event with onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.|After 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64)|The trial followed a cross over design. Descriptive analysis was based on the safety analysis set (subjects receiving at least one dose of the investigational product or its comparator). Number of subjects analysed=subjects with available data for the endpoint as per individual trial products. Statistical analysis was performed on full analysis set||events|||Number
651326|NCT02030600|Primary|Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Maintenance Period|Severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe and/or BG confirmed by a plasma glucose value of <56 mg/dL (3.1 mmol/L), with symptoms consistent with hypoglycaemia. Treatment emergent hypoglycaemic episode was defined as an event with onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.|After 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64)|The trial followed a cross over design. Descriptive analysis was based on the safety analysis set (subjects receiving at least one dose of the investigational product or its comparator). Number of subjects analysed=subjects with available data for the endpoint as per individual trial products. Statistical analysis was performed on full analysis set||events|||Number
651327|NCT02030574|Secondary|Number of Participants Experiencing Toxicities With Neoadjuvant Gemcitabine and Fractionated Cisplatin for Patients With Bladder Cancer|Toxicities assessed while patients are on treatments|Prior to each of the 4 cycles of treatment, after 4 months of treatment, 30 days post the last dose of drug (for a total of approximately 5 months)|||participants|||Number
651328|NCT02030574|Primary|Pathologic Complete Response Rate of Neoadjuvant Gemcitabine and Fractionated Cisplatin for Patients With Muscle Invasive Bladder Cancer Whom Are Not Candidates for High Dose Cisplatin.|Response will be evaluated in this study using the international criteria proposed in the Revised Response Evaluation Criteria in Solid Tumors (RECIST) Guideline version 1.1 [Eur J Cancer. 2009;45:228-247.].Complete Response (CR): Disappearance of all target lesions; Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficie|at approximately 6 months|||participants|||Number
651329|NCT02030535|Secondary|QRS Change From Patient Baseline at Individual Post-dose Time Points|QRS change from patient baseline at individual post-dose time points|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)||ms||Standard Deviation|Mean
651330|NCT02030535|Secondary|Peak QRS (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points|Peak QRS change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)||ms||Standard Deviation|Mean
651331|NCT02030535|Secondary|Mean QRS (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points|Mean QRS change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)||ms||Standard Deviation|Mean
651332|NCT02030535|Secondary|PR Change From Patient Baseline at Individual Post-dose Time Points|PR change from patient baseline at individual post-dose time points|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)||ms||Standard Deviation|Mean
651333|NCT02030535|Secondary|Peak PR (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points|Peak PR change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)||ms||Standard Deviation|Mean
651334|NCT02030535|Secondary|Mean PR (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points|Mean PR change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)||ms||Standard Deviation|Mean
651335|NCT02030535|Secondary|QTcB Change From Patient Baseline at Individual Post-dose Time Points|QTcB change from patient baseline at individual post-dose time points|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)||ms||Standard Deviation|Mean
651336|NCT02030535|Secondary|Peak QTcB (Heart Rate Corrected QT Interval (Using Bazett Adjustment)) Change From Patient Baseline Over All Post-dose Time Points|Peak QTcB (Heart Rate Corrected QT Interval (Using Bazett Adjustment))change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)||ms||Standard Deviation|Mean
651370|NCT02029755|Secondary|Rescue Antiemetics Use||postoperative 1, 6, 12, 24, 36, 48 hour||||||
651345|NCT02030535|Primary|Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) (0-3hours) Response After Single-dose Administration|"The response was defined as the change from patient baseline. Patient baseline was the average of the mean pre-dose values (period baseline) on each test day (Visit 2 (Day 1), Visit 3 (Day 22 (±7days)), and Visit 4 (Day 43±7days)).
For patients who did not complete all periods, patient baseline was the average of the available period baselines.
The means presented are the adjusted means."|1 hour (h) and 10 min pre-dose and at 15 min, 30 min, 1 h, 2 h and 3 h post-dose|Full Analysis Set (FAS): This patient set included all patients in the TS who had at least 1 visit (Visit 2(Day1), Visit 3(Day22), or Visit 4(Day43)) with both the period baseline value plus any evaluable post-dose spirometry measurement from the same visit.||Litres||Standard Error|Mean
651346|NCT02030535|Secondary|Peak Heart Rate Change From Patient Baseline Over All Post-dose Time Points|Peak heart rate change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)||bpm||Standard Deviation|Mean
651347|NCT02030535|Secondary|Mean Heart Rate Change From Patient Baseline Over All Post-dose Time Points|Mean heart rate change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)||bpm||Standard Deviation|Mean
651348|NCT02030535|Secondary|Peak QTcF Interval Change From Patient Baseline Over All Post-dose Time Points|Peak QTcF interval change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)||ms||Standard Deviation|Mean
651349|NCT02030535|Secondary|Mean (Heart Rate Corrected QT Interval (Using Fredericia Adjustment)) QTcF Interval Change From Patient Baseline Over All Post-dose Time Points|Mean QTcF interval change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)||ms||Standard Deviation|Mean
651350|NCT02030405|Secondary|Overall Survival (OS)|Overall survival (OS) from time of study entry to the earlier of death from any cause or end of follow up at 1 year|1 year|||Participants|||Count of Participants
651351|NCT02030405|Primary|Overall Response Rate|"Overall response rate after 3 cycles of treatment (9 weeks) was assessed as complete remission (CR); CR with incomplete recovery (CRi); and partial remission (PR) with MLN9708, in patients with NPM1-mutated AML by LeukemiaNet1 guidelines:
CR is defined as either a full CR, or a CR with incomplete recovery. Although achievement of CR has unique clinical significance for improved overall survival and relapsed free survival compared to achievement of CR with incomplete platelet recovery, the latter is still a clinically meaningful response, as it is independently superior to resistant disease. Partial remission (PR) is defined as meeting all hematologic criteria for CR with an allowance for 5% to 25% bone marrow blasts or decrease of pretreatment bone marrow blast percentage by at least 50%. Stable disease is defined as a change in bone marrow aspirate blast count within 10% of baseline. Relapsed disease is defined as reappearance of blasts in the blood or bone marrow blasts"|9 weeks|||Participants|||Count of Participants
651352|NCT02030041|Primary|Skeletal Muscle Mitochondrial Content|Skeletal muscle citrate synthase activity is a validated marker of mitochondrial content. Skeletal muscle biopsy was obtained from vastus lateralis muscle of five patients in either groups before and after the intervention. Under aseptic conditions, samples were taken in protease inhibitor cocktail and stored at -80ºC. Mitochondrial citrate synthase activity (the working range of the kit was 1.56-100 µg/mL, with intra and inter assay CV of 4.35-6.55 % and 8.3 % respectively) was measured using ELISA Kit (Abcam, Cambridge, UK) as per manufacturer’s instructions.Skeletal muscle citrate synthase activity is a validated marker of mitochondrial content.|Twelve weeks|||change in mOD/min at 412nm||Standard Deviation|Mean
651353|NCT02030041|Primary|Peak Oxygen Consumption|Peak oxygen consumption( VO2peak) is defined as the highest rate at which oxygen can be taken up and utilized by the body during severe exercise. The participants were encouraged to exercise to exhaustion with progressive 2-minutes increments in the power output during the test. VO2peak was obtained when participants reached volitional exhaustion and met at least one of the following criteria: plateau in oxygen consumption despite increase in workload, rating of perceived exertion >18, Respiratory exchange ratio > 1.10 and peak heart rate within 10 beats of age predicted maximum. . As VO2peak (expressed as liters of oxygen consumed per minute) is also dependent on age, sex, and body size, it was expressed as percentage of the predicted value(VO2peak%).|Twelve weeks|||percentage of predicted value||Standard Deviation|Mean
651354|NCT02029989|Secondary|Sustainability of Cholestech LDX ® Glucose/Lipid and Glycosylated Hemoglobin A1c Now® Testing|Assess sustainability by comparing third party payor reimbursements for Cholestech LDX ® glucose/lipid and glycosylated hemoglobin A1c Now® tests to the actual cost of laboratory testing over a 12 month duration in community mental health clinic settings.|12 months||||||
651355|NCT02029989|Secondary|Comprehensive Medication Management (CMM) Service|Evaluate pharmacist provided comprehensive medication management (CMM) services ability to: (a) identify and reduce the number of drug therapy related problems (i.e., need for additional medications, non-adherence, unnecessary drug therapy problems, etc.) and increase primary care follow-up visits in the past 12 months compared to controls; (b) Reduce the odds of metabolic syndrome by increasing the number of subjects achieving treatment goals for dyslipidemia, hypertension, and diabetes based POCT analyses and the criteria established by the American Diabetes Association (ADA) 2013, National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III, and Joint National Committee 7 (JNC-7) at the end of 12-months compared to controls.|Baseline, 6 months, and 12 months||||||
651356|NCT02029989|Primary|Metabolic Syndrome (MetS)|compare test results in subjects between the PCS and NCS groups, with or without pre-existing MetS and/or related metabolic conditions at baseline|Baseline|||percentage of participants|||Number
651357|NCT02029911|Post-Hoc|Subjects With Amenorrhea at 12 Months|Amenorrhea at 12 Months- Number of subjects experiencing no menstrual bleeding|12 Months|Protocol Intent-to-treat||participants|||Number
651358|NCT02029911|Secondary|Procedure Time|Procedure Time defined as time from insertion of the Disposable Handpiece to the time of removal.|< 1 hour|Subjects completing treatment||Minutes||Standard Deviation|Mean
651359|NCT02029911|Primary|Reduction in Menstrual Blood Loss to Normal Levels at 12 Months|Number of subjects in whom menstrual blood loss was reduced to normal or below normal levels at 12 months, as measured by a pictorial blood loss assessment chart (PBLAC) score of <=75.|12 Months|Protocol Intent-to-treat populations (all subjects in whom the experimental device was attempted to be placed)||participants|||Number
651375|NCT02029755|Primary|Pain Score (NRS: Numerical Rating Scale)|"pain scores of the participants will be followed at postoperative 1, 6, 24, 48 hour (up to 48 hours).
(NRS: from 0 to 10, 0 = no pain, 10 = the worst pain) The higher score idicates the worse outcome."|postoperative 24 hour dynamic|||units on a scale||Standard Error|Mean
651376|NCT02029703|Primary|Difference in Pain Score Between Groups|"The primary objective of this study is the inter-group difference in the KOOS (Knee injury and Osteoarthritis Outcome Score) pain subscale score over 12 and 24 weeks in subjects diagnosed with primary knee OA that are treated with standardized PT and Synvisc-One versus those that are treated with standardized PT and a sham injection.
The scale range is 0-100 with a higher score being better. The pain scale is a subscale of the overall KOOS, and there are no smaller subscales described or used to create this score."|12 and 24 weeks|||units on a scale||Standard Deviation|Mean
651377|NCT02029521|Secondary|Severity of Less Than 2 Bowel Movements Per Week|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe|6 months|||participants|||Number
651378|NCT02029521|Secondary|Frequency of Less Than 2 Bowel Movements Per Week|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent|6 months|||participants|||Number
651379|NCT02029521|Secondary|Severity of More Than 2 Bowel Movements Per Day|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe|6 months|||participants|||Number
651380|NCT02029521|Secondary|Frequency of More Than 2 Bowel Movements Per Day|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent|6 months|||participants|||Number
651381|NCT02029521|Secondary|Severity of Diarrhea|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe|6 months|||participants|||Number
651382|NCT02029521|Secondary|Frequency of Diarrhea|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent|6 months|||participants|||Number
651383|NCT02029521|Secondary|Severity of Heart Burn|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe|6 months|||participants|||Number
651384|NCT02029521|Secondary|Frequency of Heart Burn|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent|6 months|||participants|||Number
651385|NCT02029521|Secondary|Severity of Vomiting|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe|6 months|||participants|||Number
651386|NCT02029521|Secondary|Frequency of Vomiting|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent|6 months|||participants|||Number
651387|NCT02029521|Secondary|Severity of Nausea|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe|6 months|||participants|||Number
651388|NCT02029521|Secondary|Frequency of Nausea|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent|6 months|||participants|||Number
651389|NCT02029521|Secondary|Severity of Bloating|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe|6 months|||participants|||Number
651390|NCT02029521|Secondary|Frequency of Bloating|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent|6 months|||participants|||Number
651391|NCT02029521|Secondary|Severity of Lack of Appetite|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe|6 months|||participants|||Number
651392|NCT02029521|Secondary|Frequency of Lack of Appetite|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent|6 months|||participants|||Number
651393|NCT02029521|Secondary|Severity of Flatulence|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe|6 months|||participants|||Number
651394|NCT02029521|Secondary|Frequency of Flatulence|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent|6 months|||participants|||Number
651395|NCT02029521|Secondary|Severity of Belching|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe|6 months|||participants|||Number
651396|NCT02029521|Secondary|Frequency of Belching|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent|6 months|||participants|||Number
651397|NCT02029521|Secondary|Severity of Abdominal Pain|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe|6 months|||participants|||Number
651398|NCT02029521|Secondary|Frequency of Abdominal Pain|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent|6 months|||participants|||Number
651399|NCT02029521|Secondary|Bacteriology|Expectorated sputum or throat swab|6 Months|||participants|||Number
651400|NCT02029521|Secondary|Alanine Aminotransferase (ALT)|ALT was measured to determine if liver function was affected by treatment over the course of the study.|6 Months|All participants.||units per liter||Standard Deviation|Mean
651401|NCT02029521|Primary|Fecal Calprotectin|Fecal Calprotectin, a measure of gut inflammation, was measured to see if the treatment decreased this outcome.|6 months|All participants.||Micrograms/gram feces||Standard Deviation|Mean
651402|NCT02029521|Primary|Height Percentile|The subjects were measured over the course of the study to determine if treatment improved height percentile.|6 Months|All participants.||Percentile adjusted for age and sex||Standard Deviation|Mean
651403|NCT02029521|Primary|Weight Percentile|Weight percentile, adjusted for sex and age|6 months|All participants.||Percentile adjusted for age and sex||Standard Deviation|Mean
651404|NCT02029521|Secondary|Vitamin E|Serum Vitamin E levels were measured to determine if treatment affected this test.|6 months|All participants.||milligrams per liter||Standard Deviation|Mean
651405|NCT02029521|Secondary|White Blood Cell Count|White blood cell count was measure at the beginning and end of the study to determine if treatment affected this test.|6 months|All participants.||1000 cells/mm^3||Standard Deviation|Mean
651406|NCT02029521|Primary|BMI Percentile|Body Mass Index percentile adjusted for sex and age. Not available for participants under 2 years of age.|6 months|All old enough to have BMI percentile calculated. BMI percentile not available for children under 2 years of age||Percentile adjusted for age and sex||Standard Deviation|Mean
651407|NCT02029521|Secondary|C-Reactive Protein (CRP)|CRP was measured to determine if this test fell during the course of treatment.|6 months|All participants.||milligrams per liter||Standard Deviation|Mean
651408|NCT02029521|Secondary|FEV1|Forced expiratory volume at one second, percent predicted.|6 months|PFT's not done on children under age of 5.||Percent predicted||Standard Deviation|Mean
651417|NCT02029495|Primary|American College of Rheumatology (ACR) 20 Response|An ACR20 response is defined as at least 20% improvement of tender and swollen joint counts combined with at least 20% improvement in at least 3 of the following 5 parameters: Patients Global Assessment, PtGA of disease activity, patient’s assessment of pain, Health Assessment Questionnaire-Disability Index (HAQ-DI), and either Erythrocycte sedimentation rate (ESR) or C-Reactive protein (CRP) (ACR components).|16 weeks|||percentage of participants||95% Confidence Interval|Number
651418|NCT02029417|Primary|Frequency of Adverse Events, Graded According to NCI CTCAE v4.0|Maximum grade per participant of any AE.|Up to 30 days after last dose of study drugs|All treated and eligible patients.||participants|||Number
651419|NCT02029417|Primary|Proportion of the Evaluable Population of Interest Who Experience a Complete Response in the Poor and Good Prognosis Groups|Defined as recovery of morphologically normal bone marrow (< 5% blasts) and blood counts (absolute neutrophil count >= 1x10^9/L, platelet counts >= 100x10^9/LO) and rare circulating leukemic blasts or evidence of extramedullary disease. Analyzed using exact binomial probabilities in a two-stage design. The number of responses will be tabulated.|Up to 4 years|Due to the study's early termination and low accrual, data were not collected for this assessment.|||||
651420|NCT02029196|Secondary|Exhaled Carbon Monoxide|Level of exhaled carbon monoxide at Week 12|12 weeks|Measure performed on subjects who completed the 12-week study (286 in the e-vapour product arm and 100 in the conventional cigarette arm).||parts per million (ppm)||Standard Deviation|Mean
651421|NCT02029196|Primary|Adverse Events|Frequency of adverse events|12 weeks|All subjects who used the study product at least once.||percentage of adverse events||95% Confidence Interval|Least Squares Mean
651422|NCT02028780|Secondary|AUEC2-12|"Area under the effect curve over the time interval from 2 to 12h, AUEC2-12 on Days 4 and 11 for diluted thrombin time (dTT).
For dose groups 5 to 7(day4-Part-II): 74h, 74.5h, 75h, 76h, 78h, 80h, 82h, 84h on day 4. For dose groups 5 to 7(day11-Part-II): 242h, 242.083h, 242.167h, 242.5h, 243h, 244h, 246h, 248h, 250h, 252h. For dose groups 8(day4-Part-II): 74.5 h, 78 h, 84 h on day 4. For dose groups 8(day11-Part-II): 242h, 242.083h,242.25h, 242.333h, 243.333h, 244h, 246h, 248h, 252h on day 11.
AUEC is calculated by multiplying the ratio (Value at each time point/Ebase, unit of Vaue is [s] and Ebase is value [s] at baseline) by time. Therefore, Unit for AUEC2-12 is [h]."|Day 4 and Day 11 (Part II); Time frame are provided in detail in the Description section|Pharmacodynamic set (PDS): The PDS comprised all subjects in the TS who provided at least 1 evaluable predose and 1 on-treatment pharmacodynamic observation.||h||Standard Deviation|Mean
651423|NCT02028780|Secondary|Ae0-73 for the Dose Group 4 in the Part I|Amount of the analyte excreted in urine over the time interval 0-73|For dose group 4 (day1 to day4-Part-1): 0-7h, 7-13h, 13-25h, 25-49h, 49-73h|PKS set. The results from dose group 4 has been disclosed, because only dose group 4 had 1hr infusion, Ae 0-73 was reported, instead of Ae0-72.||μmol||Geometric Coefficient of Variation|Geometric Mean
651424|NCT02028780|Secondary|Ae0-72 for Idarucizumab in the Part I & Part II.|Amount of idarucizumab eliminated in urine over the time interval 0-72. Time frame: For dose groups 1 to 3 (day1 to day4-Part-1):0–4 h, 4–8 h, 8–12 h, 12–24 h, 24–48 h, 48–72 h. For dose groups 5 to 7 (day 11 to day14-Part-II): 0-4 h, 4–8 h, 8–10 h, 10–12 h,12–24 h, 24–48 h, and 48–72 h. For dose groups 8 (day11 to day14-Part-II): 0-4h, 4–8 h, 8–10 h, 10–24 h, 24–48 h, 48–72 h.|Day 1 to 4 (Part I) and Day 11 to 14 (Part II); Time frame are provided in detail in the Description section|PKS set. Ae 0-72 data is not available for BI8000mg_1h (Dose group 4 - Part I) due to longer infusion time resulting different urine collection interval. Instead, Ae 0-73 is presented for BI8000mg_1h as separate endpoint.||μmol||Geometric Coefficient of Variation|Geometric Mean
651425|NCT02028780|Secondary|AUC0-inf for Idarucizumab in the Part I & Part II.|"Area under the concentration-time curve of the analyte in plasma for idarucizumab over the time interval from 0 extrapolated to infinity.
Time frame: For dose group 1 to 3 (Day 1 to 3-Part-I): predose, 0 (end of infusion), 0.033h, 0.083, 0.167h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h. For dose group 4 (Day 1 to 3-Part-I): predose, −0.5h, 0 (end of infusion), 0.033h, 0.083h, 0.167h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 48h. For dose group 5-7 (Day11 to Day13-Part II): predose, 242h (end of infusion), 242.033h, 242.083h, 242.167h, 242.25h, 242.5h, 242.75h, 243h, 243.5h, 244h, 244.5h, 245h, 246h, 248h, 250h, 252h, 254h, 258h, 266h, 290h.For dose group 8 (day11 to Day13-Part II): predose, 242h (end of infusion), 242.083h, 242.25h, 242.333h, 242.367h, 242.5h, 242.833h, 243.333h, 244h, 245h, 246h, 248h, 252h, 254h, 266h, 290h, 314h."|Day 1 to 3 (Part I) and Day 11 to 13 (Part II); Time frame are provided in detail in the Description section|PKS set||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
651426|NCT02028780|Secondary|Cmax for Idarucizumab in the Part I & Part II.|Maximum measured concentration of the analyte in plasma for idarucizumab Time frame: For dose group 1 to 3 (Day 1 to 3-Part-I): predose, 0 (end of infusion), 0.033h, 0.083h, 0.167h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h. For dose group 4 (Day 1 to 3-Part-I): predose, −0.5h, 0 (end of infusion), 0.033h, 0.083h, 0.167h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 48h. For dose group 5-7 (Day11 to Day13-Part II): predose, 242h (end of infusion), 242.033h, 242.083h, 242.167h, 242.25h, 242.5h, 242.75h, 243h, 243.5h, 244h, 244.5h, 245h, 246h, 248h, 250h, 252h, 254h, 258h, 266h, 290h.For dose group 8 (day11 to Day13-Part II): predose, 242h (end of infusion), 242.083h, 242.25h, 242.333h, 242.367h, 242.5h, 242.833h, 243.333h, 244h, 245h, 246h, 248h, 252h, 254h, 266h, 290h, 314h.|Day 1 to 3 (Part I) and Day 11 to 13 (Part II); Time frame are provided in detail in the Description section|PKS set||nmol/L||Geometric Coefficient of Variation|Geometric Mean
651427|NCT02028780|Secondary|AUC2-12,ss on Days 4 and 11 for Unbound Sum Dabigatran (Part II).|"Area under the concentration-time curve of the dabigatran in plasma at steady state over the time interval 2 hours-12 hours.
Time Frame: For dose group 5 to 7 (Day 1 to 3-Part-I):74hours (h), 74.5h, 75h, 76h, 78h, 80h, 82h, 84h, For dose group 8 (Day 1 to 3-Part-I): 74h, 74.5h, 75h, 76h, 78h, 80h, 82h, 84h and For dose group 5-7 (Day11 to Day13-Part II):242h, 242.167h, 242.5h, 243h, 244h,246h, 248h, 250h, 252h. For dose group 8 (Day11 to Day13-Part II):242h, 242.083h, 242.25h, 242.333h, 243.333h, 244h, 246h, 248h, 252h."|Day 4 (Part I) and Day 11 (Part II). Time frame are provided in detail in the Description section|PKS set||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
651457|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: New Grade 3 or 4 Adverse Event (AE), Not Solely Related to HIV|Number of participants with a new grade 3 or 4 adverse event (AE), not solely related to HIV, to be analysed using time-to-event methods|Median 2 years (from once vs twice daily randomization to 16 March 2012; maximum 2.6 years)|||participants|||Number
651428|NCT02028780|Secondary|Ae0−74,ss on Days 4 and 11 for Sum Dabigatran (Part II)|Amount of analyte eliminated in urine at steady state from the time point 0 hours to time point 74 hours.|0–2 h, 2–6 h, 6–10 h, 10–12 h,12–14h, 14-26 h, 26-50 h, 50-74 h after drug administration of dabigatran etexilate on Day 4 and Day 11.|PKS set: This subject set included all subjects who received the idarucizumab and who had at least one pharmacokinetic parameter. For the Part 2, subjects who had the emesis with onset at or before twice the median tmax of dabigatran were not included in this set.||μg||Geometric Coefficient of Variation|Geometric Mean
651429|NCT02028780|Primary|Percentage of Subjects With Drug-related Adverse Events in Part 1 and Part 2|Percentage of subjects with drug-related adverse events in Part 1 and Part 2.|From first drug administration until 13 weeks after the last drug administration, upto 98 days (Part-I) & upto 108 days (Part-II)|Treated set (TS)||Percentage of participants|||Number
651430|NCT02028767|Secondary|AUC (0-infinity) (Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval From 0 Extrapolated to Infinity)|AUC (0-infinity) (Area under the concentration-time curve of metformin in plasma over the time interval from 0 extrapolated to infinity)|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|PKS: includes all subjects of the TS who provided at least 1 observation for at least 1 primary pharmacokinetic endpoint, and had no important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
651431|NCT02028767|Primary|Cmax (Maximum Measured Concentration of Metformin in Plasma)|Cmax (maximum measured concentration of metformin in plasma)|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|PKS: includes all subjects of the TS who provided at least 1 observation for at least 1 primary pharmacokinetic endpoint, and had no important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
651432|NCT02028767|Primary|AUC (0-tz) (Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point)|AUC (0-tz) (area under the concentration-time curve of metformin in plasma over the time interval from 0 to the last quantifiable data point)|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|Pharmacokinetic set (PKS): includes all subjects of the TS who provided at least 1 observation for at least 1 primary pharmacokinetic endpoint, and had no important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
651433|NCT02028754|Secondary|Subjective Symptom Total Score in the Study Eye|The following 11 subjective symptoms are evaluated in the study eye: foreign body sensation, photophobia, itching, pain in the eye, dry eye, eye heaviness, blurred vision, eye fatigue, eye discomfort, eye secretions and tears. Each of these symptoms is divided into 4 classes: no symptom=0; occasional symptoms=1; intermittent mild symptoms=2; and persistent obvious symptoms=3. The total score ranged from 0 (best) to 33 (worst).|Day 7, Day 30|All patients with data at this time point||Scores on a Scale||Standard Deviation|Mean
651434|NCT02028754|Secondary|Ocular Surface Disease Index (OSDI) Questionnaire Score in the Study Eye|The OSDI is a 12-question survey for patients to document their dry eye disease symptoms in the study eye. The OSDI consists of a 5-point scale (0=none of the time and 4 = all of the time), with higher scores representing greater disability. The scores are totaled over the 12 questions and converted to a score of 0-100 (0=no disability and 100=complete disability).|Day 7, Day 30|All patients with data at this time point||Scores on a Scale||Standard Deviation|Mean
651435|NCT02028754|Secondary|Results of Schirmer I Test With Anesthetics in the Study Eye|The Schirmer I test consists of anesthetic drops being placed into the lower eyelid of the study eye. Patients then close their eyes. Test paper is placed on the lower eyelid of the patient's closed eyes. The paper is then removed and the moisture length on the paper recorded. Shorter distances indicate worse dry eye symptoms.|Day 7, Day 30|All patients with data at this time point||Millimeters||Standard Deviation|Mean
651436|NCT02028754|Secondary|Lissamine Green Staining Score in the Study Eye|Conjunctival and corneal staining are evaluated following ocular administration of lissamine green dye in the study eye. The conjunctiva is the clear membrane covering the white surface of the eye. The cornea is the transparent front part of the eye which covers the iris and pupil. The conjunctiva and cornea are divided into 5 regions that are scored based on the extent of staining. Scores range from 0 to 3 points: 0=non-staining, 1=staining range < 1/2 of the conjunctiva and cornea, 2=staining range ≥ 1/2 of the conjunctiva and cornea, and 3=regional whole staining of the conjunctiva and cornea. The total score ranges from 0 to 15 points. The higher the grade score, the worse the dry eye condition.|Day 7, Day 30|All patients with data at this time point||Scores on a Scale||Standard Deviation|Mean
651437|NCT02028754|Secondary|Fluorescein Staining Score in the Study Eye|The cornea is evaluated following ocular administration of fluorescein stain in the study eye. The cornea is the transparent front part of the eye which covers the iris and pupil. The cornea is divided into 3 regions. Each region is scored according to the extent of staining, with scores ranging from 0 to 3 points: 0=non-staining, 1=staining range < 1/2 of the cornea, 2=staining range ≥ 1/2 of the cornea, and 3=regional whole staining of the cornea. The total score ranges from 0 to 9 points. The higher the staining score, the worse the dry eye condition.|Day 7, Day 30|All patients with data at this time point||Scores on a Scale||Standard Deviation|Mean
651438|NCT02028754|Primary|Tear Break-Up Time (TBUT) in the Study Eye|TBUT is the time required for dry spots to appear on the surface of the study eye after blinking. The longer it takes, the more stable the tear film. A short TBUT is a sign of poor tear film.|Day 30|All patients with data at this time point||Seconds||Standard Deviation|Mean
651439|NCT02028754|Primary|Tear Break-Up Time (TBUT) in the Study Eye|TBUT is the time required for dry spots to appear on the surface of the study eye after blinking. The longer it takes, the more stable the tear film. A short TBUT is a sign of poor tear film.|Day 7|All patients with data at this time point||Seconds||Standard Deviation|Mean
651475|NCT02028676|Secondary|LCM vs CDM, Induction ART: Cessation of First-line Regimen for Clinical/Immunological Failure|Number of participants stopping their first-line regimen for clinical/immunological failure, to be analysed using time-to-event methods|Median 4 years (from randomization to 16 March 2012; maximum 5 years)|||participants|||Number
651440|NCT02028676|Secondary|Cotrimoxazole: Adherence to ART as Measured by Self-reported Questionnaire (Missing Any Pills in the Last 4 Weeks)|Binary outcome measure: missed any doses of ART in the last 4 weeks by self-report. Mean calculated across all 12-weekly visits attended over the whole follow-up (no specific timepoint prespecified), giving the percentage of visits attended where the carer/participant reported missing any pills in the last 4 weeks.|Mean over median 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)|||% of visits reporting missed pills||Standard Deviation|Mean
651441|NCT02028676|Secondary|Cotrimoxazole: New Serious Adverse Events Not Solely Related to HIV|Number of participants with a new serious adverse event not solely related to HIV, to be analysed using time-to-event methods|Median 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)|||participants|||Number
651442|NCT02028676|Secondary|Cotrimoxazole: Change From Baseline in Absolute CD4 to Week 72|Estimated in those >5 years at randomization to stop vs continue, in whom absolute CD4 is meaningful. (In uninfected children, CD4 decreases with age during early childhood.)|Baseline, week 72|All participants aged >5 years at randomization to stop versus continue alive in follow-up with CD4 measured||cells per mm3||Standard Deviation|Mean
651443|NCT02028676|Secondary|Cotrimoxazole: Change From Baseline in CD4% to Week 72||Baseline, week 72|All participants alive in follow-up with CD4%||percentage of total lymphocytes||Standard Deviation|Mean
651444|NCT02028676|Secondary|Cotrimoxazole: Body Mass Index-for-age Z-score|Age-adjusted change in body mass index-for-age Z-score at all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29).|Baseline and a median of 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)|||age-adjusted z-score||Standard Deviation|Mean
651445|NCT02028676|Secondary|Cotrimoxazole: Height-for-age Z-score|Age-adjusted change in height-for-age Z-score at all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29).|Baseline and a median of 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)|||age-adjusted z-score||Standard Deviation|Mean
651446|NCT02028676|Secondary|Cotrimoxazole: Weight-for-age Z-score|Age-adjusted change in weight-for-age Z-score at all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29).|Baseline and a median of 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)|||age-adjusted z-score||Standard Deviation|Mean
651447|NCT02028676|Secondary|Cotrimoxazole: All-cause Mortality|Number of participants who died, to be analysed using time-to-event methods|Median 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)|||participants|||Number
651448|NCT02028676|Secondary|Cotrimoxazole: New WHO Stage 4 Event or Death|Number of participants with a new WHO stage 4 event or death, to be analysed using time-to-event methods|Median 2 years (from randomization to 16 March 2012; maximum 2.5 years)|||participants|||Number
651449|NCT02028676|Secondary|Cotrimoxazole: New WHO Stage 3 Severe Recurrent Pneumonia or Diarrhoea|Number of participants with a new WHO stage 3 severe recurrent pneumonia or diarrhoea, to be analysed using time-to-event methods|Median 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)|||participants|||Number
651450|NCT02028676|Secondary|Cotrimoxazole: New WHO Stage 3 or 4 Event or Death|Number of participants with a new WHO stage 3 or 4 event or death, to be analysed using time-to-event methods|Median 2 years (from randomization to 16 March 2012; maximum 2.5 years)|||participants|||Number
651451|NCT02028676|Secondary|Cotrimoxazole: New Severe Pneumonia|Number of participants with a new severe pneumonia, to be analysed using time-to-event methods|Median 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)|||participants|||Number
651452|NCT02028676|Secondary|Cotrimoxazole: New Clinical and Diagnostic Positive Malaria|Number of participants with a new clinical and diagnostic positive malaria, to be analysed using time-to-event methods. Diagnostic positive by either microscopy (thick film) or rapid diagnostic test (RDT)|Median 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)|||participants|||Number
651453|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: Adherence to ART as Measured by Self-reported Questionnaire (Missing Any Pills in the Last 4 Weeks)|Binary outcome measure: missed any doses of ART in the last 4 weeks by self-report. Mean calculated across all 12-weekly visits attended over the whole follow-up (no specific timepoint prespecified), giving the percentage of visits attended where the carer/participant reported missing any pills in the last 4 weeks.|Mean over median 2 years (from once vs twice daily randomization to 16 March 2012; maximum 2.6 years)|||% of visits reporting missed pills||Standard Deviation|Mean
651454|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: Adherence to ART as Measured by Self-reported Questionnaire (Missing Any Pills in the Last 4 Weeks) at 96 Weeks|Number of participants reporting missing any doses of ART in the last 4 weeks by self-report at 96 weeks.|96 weeks after randomization to once- versus twice-daily|All participants completing the questionnaire||participants|||Number
651455|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: Adherence to ART as Measured by Self-reported Questionnaire (Missing Any Pills in the Last 4 Weeks) at 48 Weeks|Number of participants reporting missing any doses of ART in the last 4 weeks by self-report at 48 weeks.|48 weeks after randomization to once- versus twice-daily|All participants completing the questionnaire||participants|||Number
651456|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: New Serious Adverse Events Not Solely Related to HIV|Number of participants with a new serious adverse event not solely related to HIV, to be analysed using time-to-event methods|Median 2 years (from once vs twice daily randomization to 16 March 2012; maximum 2.6 years)|||participants|||Number
651458|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: Body Mass Index-for-age Z-score|Age-adjusted change in body mass index-for-age Z-score at all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29).|Baseline and a median of 2 years (from once vs twice daily randomization to 16 March 2012; maximum 2.6 years)|||age-adjusted z-score||Standard Deviation|Mean
651459|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: Weight-for-age Z-score|Age-adjusted change in weight-for-age Z-score at all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29).|Baseline and a median of 2 years (from once vs twice daily randomization to 16 March 2012; maximum 2.6 years)|||age-adjusted z-score||Standard Deviation|Mean
651460|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: Height-for-age Z-score|Age-adjusted change in height-for-age Z-score over all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29).|Baseline and a median of 2 years (from once vs twice daily randomization to 16 March 2012; maximum 2.6 years)|||age-adjusted z-score||Standard Deviation|Mean
651461|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: New WHO Stage 3 or 4 Event or Death|Number of participants with a new WHO stage 3 or 4 event or death, to be analysed using time-to-event methods|Median 2 years (from randomization to 16 March 2012; maximum 2.6 years)|||participants|||Number
651462|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: New WHO Stage 4 Event or Death|Number of participants with a new WHO stage 4 event or death, to be analysed using time-to-event methods|Median 2 years (from randomization to 16 March 2012; maximum 2.6 years)|||participants|||Number
651463|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: All-cause Mortality|Number of participants who died, to be analysed using time-to-event methods|Median 2 years (from randomization to 16 March 2012; maximum 2.6 years)|||participants|||Number
651464|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in Absolute CD4 to Week 96|All participants aged >5 years at randomization to once versus twice daily alive in follow-up with CD4 measured|Randomisation to once vs twice daily, week 96|All participants aged >5 years at randomization to once versus twice daily alive in follow-up with CD4 measured||cells per mm3||Standard Deviation|Mean
651465|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in Absolute CD4 to Week 72|All participants aged >5 years at randomization to once versus twice daily alive in follow-up with CD4 measured|Baseline, week 72|All participants aged >5 years at randomization to once versus twice daily alive in follow-up with CD4 measured||cells per mm3||Standard Deviation|Mean
651466|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in Absolute CD4 to Week 48|Estimated in those >5 years at enrolment, in whom absolute CD4 is meaningful. (In uninfected children, CD4 decreases with age during early childhood.)|Randomisation to once vs twice daily, week 48|All participants aged >5 years at randomization to once versus twice daily alive in follow-up with CD4 measured||cells per mm3||Standard Deviation|Mean
651467|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in CD4% to Week 96||Randomisation to once vs twice daily, week 96|All participants alive in follow-up with CD4%||percentage of lymphocytes||Standard Deviation|Mean
651468|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in CD4% to Week 72||Baseline, week 72|All participants alive in follow-up with CD4%||percentage of total lymphocytes||Standard Deviation|Mean
651469|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in CD4% to Week 48||Randomisation to once vs twice daily, week 48|All participants alive in follow-up with CD4%||percentage of total lymphocytes||Standard Deviation|Mean
651470|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: Suppression of HIV RNA Viral Load 96 Weeks After Randomisation|Number of participants with HIV RNA viral load <80 copies/ml at 96 weeks. Threshold for suppression <80 copies/ml as samples had to be diluted due to low volumes.|96 weeks|All participants with viral load assayed in stored specimens (98% of those randomized)||participants|||Number
651471|NCT02028676|Secondary|LCM vs CDM, Induction ART: Adherence to ART as Measured by Self-reported Questionnaire (Missing Any Pills in the Last 4 Weeks)|Binary outcome measure: missed any doses of ART in the last 4 weeks by self-report. Mean calculated across all 12-weekly visits attended over the whole follow-up (no specific timepoint prespecified), giving the percentage of visits attended where the carer/participant reported missing any pills in the last 4 weeks.|Median 4 years (from randomization to 16 March 2012; maximum 5 years)|||% of visits reporting missed pills||Standard Deviation|Mean
651472|NCT02028676|Secondary|LCM vs CDM, Induction ART: New ART-modifying Adverse Event|Number of participants with a new ART-modifying adverse event, to be analysed using time-to-event methods|Median 4 years (from randomization to 16 March 2012; maximum 5 years)|||participants|||Number
651473|NCT02028676|Secondary|LCM vs CDM, Induction ART: New Serious Adverse Events Not Solely Related to HIV|Number of participants with a new serious adverse events not solely related to HIV, to be analysed using time-to-event methods|Median 4 years (from randomization to 16 March 2012; maximum 5 years)|||participants|||Number
651474|NCT02028676|Secondary|LCM vs CDM, Induction ART: New Grade 3 or 4 Adverse Event Definitely/Probably or Uncertainly Related to ART|Number of participants with a new grade 3 or 4 adverse event definitely/probably or uncertainly related to ART, to be analysed using time-to-event methods|Median 4 years (from randomization to 16 March 2012; maximum 5 years)|||participants|||Number
655259|NCT01953328|Secondary|Percent Change From Baseline in Apolipoprotein B at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
651476|NCT02028676|Secondary|CDM vs LCM, Induction ART: Suppression of HIV RNA Viral Load 144 Weeks After Baseline|Number of participants with HIV RNA viral load <80 copies/ml 144 weeks after baseline. Threshold for suppression <80 copies/ml as samples had to be diluted due to low volumes.|144 weeks|Viral load was assayed retrospectively at week 144 on a random subset of participants, plus all those aged <5 years at enrolment||participants|||Number
651477|NCT02028676|Secondary|CDM vs LCM, Induction ART: Suppression of HIV RNA Viral Load 72 Weeks After Baseline|Number of participants with HIV RNA viral load <80 copies/ml 72 weeks after baseline. Threshold for suppression <80 copies/ml as samples had to be diluted due to low volumes.|72 weeks|Viral loads were assayed retrospectively in a random subset of children||participants|||Number
651478|NCT02028676|Secondary|LCM vs CDM, Induction ART: Change From Baseline in Absolute CD4 to Week 144|Estimated in those >5 years at enrolment, in whom absolute CD4 is meaningful. (In uninfected children, CD4 decreases with age during early childhood.)|Baseline, week 144|All participants alive in follow-up with CD4||absolute cells per mm3||Standard Error|Mean
651479|NCT02028676|Secondary|LCM vs CDM, Induction ART: Change From Baseline in Absolute CD4 to Week 72|Estimated in those >5 years at enrolment, in whom absolute CD4 is meaningful. (In uninfected children, CD4 decreases with age during early childhood.)|Baseline, week 72|All participants alive in follow-up with CD4||absolute cells per mm3||Standard Error|Mean
651480|NCT02028676|Secondary|LCM vs CDM: Change From Baseline in CD4% to Week 144||Baseline, week 144|All participants alive in follow-up with CD4% (95% completeness)||percentage of total lymphocytes||Standard Error|Mean
651481|NCT02028676|Secondary|LCM vs CDM: Change From Baseline in CD4% to Week 72||Baseline, week 72|All participants alive in follow-up with CD4% (97% completeness)||percentage of total lymphocytes||Standard Error|Mean
651482|NCT02028676|Secondary|LCM vs CDM, Induction ART: Body Mass Index-for-age Z-score|Age-adjusted change in body mass index-for-age Z-score at all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29).|Baseline and a median of 4 years (maximum 5 years)|||age-adjusted z-score||Standard Deviation|Mean
651483|NCT02028676|Secondary|LCM vs CDM, Induction ART: Height-for-age Z-score|Age-adjusted change in weight-for-age Z-score at all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29).|Baseline and a median of 4 years (maximum 5 years)|||age-adjusted z-score||Standard Deviation|Mean
651484|NCT02028676|Secondary|LCM vs CDM, Induction ART: Weight-for-age Z-score|Age-adjusted change in weight-for-age Z-score at all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29).|Baseline and a median of 4 years (maximum 5 years)|||age-adjusted z-score||Standard Deviation|Mean
651485|NCT02028676|Secondary|LCM vs CDM, Induction ART: New or Recurrent WHO Stage 3 or 4 Event or Death|Number of participants with a new or recurrent WHO stage 3 or 4 event or death, to be analysed using time-to-event methods|Median 4 years (from randomization to 16 March 2012; maximum 5 years)|||participants|||Number
651486|NCT02028676|Secondary|LCM vs CDM, Induction ART: New WHO Stage 3 or 4 Event or Death|Number of participants with a new WHO stage 3 or 4 event or death, to be analysed using time-to-event methods|Median 4 years (from randomization to 16 March 2012; maximum 5 years)|||participants|||Number
651487|NCT02028676|Secondary|Induction ART: New WHO Stage 4 Event or Death|Number of participants with a new WHO stage 4 event or death, to be analysed using time-to-event methods|Median 4 years (from randomization to 16 March 2012; maximum 5 years)|||participants|||Number
651488|NCT02028676|Secondary|LCM vs CDM, Induction ART: All-cause Mortality|Number of participants who died from any cause, to be analysed using time-to-event methods|Median 4 years (from randomization to 16 March 2012; maximum 5 years)|||participants|||Number
651489|NCT02028676|Primary|Cotrimoxazole: New Grade 3 or 4 Adverse Event (AE), Not Solely Related to HIV|Number of participants with a new grade 3 or 4 adverse event (AE), not solely related to HIV, to be analysed using time-to-event methods|Median 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)|||participants|||Number
651490|NCT02028676|Primary|Cotrimoxazole: New Hospitalisation or Death|Number of participants with a new hospitalisation or death, to be analysed using time-to-event methods|Median 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)|||participants|||Number
651491|NCT02028676|Primary|Once Versus Twice Daily Abacavir+Lamivudine: New Grade 3 or 4 Adverse Event (AE), Not Solely Related to HIV, Judged Definitely/Probably or Uncertain Whether Related to Lamivudine or Abacavir|Number of participants with a new grade 3 or 4 adverse event (AE), not solely related to HIV, judged definitely/probably or uncertain whether related to lamivudine or abacavir, to be analysed using time-to-event methods|Median 2 years (from once vs twice daily randomization to 16 March 2012; maximum 2.6 years)|||participants|||Number
651492|NCT02028676|Primary|Once Versus Twice Daily Abacavir+Lamivudine: Suppressed HIV RNA Viral Load 48 Weeks After Randomisation|Number of participants with HIV RNA viral load <80 copies/ml at 48 weeks. Measured retrospectively on stored plasma specimens: due to low stored volumes from some children, samples had to be diluted and therefore a threshold of <80 copies/ml was used to indicate suppression.|48 weeks|All randomized participants with VL result from stored plasma specimen (available for 661/669, 99%, randomized participants)||participants|||Number
651493|NCT02028676|Primary|Induction ART: New Grade 3 or 4 Adverse Event (AE), Not Solely Related to HIV|Number of participants with a new grade 3 or 4 adverse event (AE), not solely related to HIV, to be analysed using time-to-event methods|Median 4 years (from randomization to 16 March 2012; maximum 5 years)|||participants|||Number
651496|NCT02028676|Primary|LCM vs CDM: New Grade 3 or 4 Adverse Event (AE), Not Solely Related to HIV|Number of participants with a new Grade 3 or 4 adverse event (AE), not solely related to HIV, to be analysed using time-to-event methods|Median 4 years (from randomization to 16 March 2012; maximum 5 years)|||participants|||Number
651497|NCT02028676|Primary|LCM vs CDM: Disease Progression to a New WHO Stage 4 Event or Death|Number of participants with disease progression to a new WHO stage 4 event or death, to be analysed using time-to-event methods|Median 4 years (from randomization to 16 March 2012; maximum 5 years)|All randomized participants (time-to-event)||participants|||Number
651498|NCT02028325|Primary|Concordance Between Surgical Impression of Residual Lesion and Appearance on Post-operative Imaging|We will perform fluorescein fluorescence/angiography at surgery and assess if fluorescence reveals any residual tumor or vascular lesion (aneurysm, arteriovenous malformation, or arteriovenous fistula) following surgical intervention. For subjects with brain tumors we will then perform a regular postoperative MRI and assess if there was any residual tumor and measure the accuracy of fluorescein fluorescence to assess the amount of the residual tumor seen on the postoperative MRI. Similarly, for the aneurysms or other vascular lesions, we will perform a regular postoperative angiogram and assess the accuracy of fluorescein angiography results in estimating the amount of residual lesion.|up to 1 week. For subjects where clinical post-operative MRI/angiography was not performed within 7 days, MRI/angiography completed within 3 months post-operatively was utilized for evaluation.|||participants|||Number
651499|NCT02028169|Secondary|Number of Participants With Serious Adverse Events (SAEs) and Discontinuations Due to Treatment-Related Adverse Events (AEs) Up to Month 9|Number of participants with any serious adverse event (SAE) occurring during treatment with anti-TNF agents and/or participants who discontinued treatment due to SAEs or AEs which were caused by the treatment with anti-TNF agents during the course of treatment. An SAE is defined as an event that: results in the death; is life-threatening; results in an admission to the hospital or prolongation of hospitalization; is a congenital anomaly; results in a condition that substantially interferes with the activities of daily living of a study subject; is an important medical event according to the Investigator.|Up to Month 9|All participants||Participants|||Count of Participants
651500|NCT02028169|Secondary|Participant’s Assessment of Pain and Fatigue VAS Up to Month 9|A VAS was used to measure the participant's assessment of pain and fatigue. For this assessment a 10-point scale was used (0: very well; 10: very poor).|Baseline, Month 3, Month 6, Month 9|Participants with an assessment at given time point.||units on a scale||Standard Deviation|Mean
651501|NCT02028169|Secondary|Participant’s Assessment of Total Back Pain VAS Up to Month 9|A VAS was used to measure the participant's assessment of back pain. For this assessment a 10-point scale was used (0: very well; 10: very poor).|Baseline, Month 3, Month 6, Month 9|Participants with an assessment at given time point.||units on a scale||Standard Deviation|Mean
651502|NCT02028169|Secondary|Participant’s Assessment of Nocturnal Back Pain and Fatigue VAS Up to Month 9|A VAS was used to measure the participant's assessment of nocturnal back pain and fatigue. For this assessment a 10-point scale was used (0: very well; 10: very poor).|Baseline, Month 3, Month 6, Month 9|Participants with an assessment at given time point.||units on a scale||Standard Deviation|Mean
651503|NCT02028169|Secondary|Physician’s Global Assessment of Disease Activity VAS Up to Month 9|A VAS was used to measure the physician's assessment of disease activity. For this assessment a 10-point scale was used (0: very well; 10: very poor).|Baseline, Month 3, Month 6, Month 9|Participants with an assessment at given time point.||units on a scale||Standard Deviation|Mean
651504|NCT02028169|Secondary|Participant’s Global Assessment of Disease Activity Visual Analog Scale (VAS) Up to Month 9|A VAS was used to measure the participant's assessment of disease activity. For this assessment a 10-point scale was used (0: very well; 10: very poor).|Baseline, Month 3, Month 6, Month 9|Participants with an assessment at given time point.||units on a scale||Standard Deviation|Mean
651505|NCT02028169|Secondary|C-reactive Protein (CRP) Up to Month 9|CRP values were measured as an inflammatory parameter. Low CRP values mean less inflammation.|Baseline, Month 3, Month 6, Month 9|Participants with an assessment at given time point.||mg/dL||Standard Deviation|Mean
651506|NCT02028169|Secondary|Erythrocyte Sedimentation Rate (ESR) Up to Month 9|ESR values were measured as an inflammatory parameter. Low ESR values mean less inflammation.|Up to Month 9|Participants with an assessment at given time point.||mm/h||Standard Deviation|Mean
651507|NCT02028169|Secondary|Levels of Rheumatoid Factor||Up to Month 9|Since sufficient data could not be collected, this analysis was not performed.|||||
651508|NCT02028169|Secondary|Number of Tender Joints Up to Month 9|Twenty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination. The presence of tenderness is scored 1 and no tenderness is 0; range of score is 0-28, with higher scores indicating more tender joints.|Baseline, Month 3, Month 6, Month 9|Participants with an assessment at given time point.||tender joints||Standard Deviation|Mean
651509|NCT02028169|Secondary|Number of Swollen Joints Up to Month 9|Twenty-eight joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination. The presence of swelling is scored 1 and no swelling is 0; range of score is 0-28, with higher scores indicating more swollen joints.|Baseline, Month 3, Month 6, Month 9|Participants with an assessment at given time point.||swollen joints||Standard Deviation|Mean
651510|NCT02028169|Secondary|Dactylitis Score Up to Month 9|A total of 20 digits were assessed as entire digits, looking for signs of tender dactylitis. Dactylitis is defined as a uniform swelling of the digits where the joints cannot be defined. Investigators entered scores between 0 (no swelling or pain) and 6 (most severe swelling and pain).|Baseline, Month 3, Month 6, Month 9|Participants with an assessment at given time point.||units on a scale||Standard Deviation|Mean
651511|NCT02028169|Secondary|Maastricht Ankylosing Spondylitis Enthesitis Scale (MASES) Up to Month 9|For calculation of the enthesitis (tenderness) score, MASES was used in practice by the physicians. This scale takes into account the sites (first costochondral joint, seventh costochondral joint, posterior superior iliac spine, anterior superior iliac spine, iliac crest, fifth lumbar spinous process and proximal insertion of the Achilles tendon) and they scored from 0 to 13. Minimum tenderness score was 0; maximum tenderness score was 13.|Baseline, Month 3, Month 6, Month 9|Participants with an assessment at given time point.||units on a scale||Standard Deviation|Mean
653514|NCT01982435|Secondary|Number of Participants With Nonperfusion|Number of participants with peripheral nonperfusion in their study eye from baseline to months 3, 6, and 12 (i.e. presence of ischemia).|3, 6 and 12 months|||Participants|||Count of Participants
651512|NCT02028169|Secondary|Disease Activity Score (DAS 28) Up to Month 9|"The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity. Participants were classified according to their scores as below:
DAS28 > 5.1 = High disease activity
DAS28 < 3.2 = Low disease activity
DAS28 < 2.6 = Remission"|Baseline, Month 3, Month 6, Month 9|All participants||Participants|||Count of Participants
651513|NCT02028169|Secondary|Percentage of Participants With American College of Rheumatology 20%, 50%, 70% (ACR20, ACR50, ACR70) Response at Month 9|"A participant is an ACR20, ACR50, or ACR70 responder if the following 3 criteria for improvement from Baseline are met:
≥ 20%, ≥ 50%, or ≥ 70% improvement in tender joint count;
≥ 20%, ≥ 50%, or ≥ 70% improvement in swollen joint count; and
≥ 20%, ≥ 50%, or ≥ 70% improvement in at least 3 of the 5 following parameters:
Physician's global assessment of disease activity
Participant's global assessment of disease activity
Participant's assessment of pain
HAQ-DI
Acute phase reactant (erythrocyte sedimentation rate/C-reactive protein)."|Month 9|Participants with an assessment.||percentage of participants|||Number
651514|NCT02028169|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI) Score Up to Month 9|The HAQ-DI is a participant-reported questionnaire. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide a total score ranging from 0 (no disability) to 3 (very severe, high-dependency disability).|Baseline, Month 3, Month 6, Month 9|Participants with an assessment at given time point.||units on a scale||Standard Deviation|Mean
651515|NCT02028169|Primary|WPAI Questionnaire: Mean Percentage of Activity Impairment Due to PsA Up to Month 9|Activity impairment due to PsA (the extent to which PsA affected the ability to perform usual daily activities) is presented as the mean percentage of activity impairment, calculated as 100*scale value of WPAI question 6 (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.|Baseline, Month 3, Month 6, Month 9|Participants with an assessment at given time point.||percentage of activity impairment||Standard Deviation|Mean
651516|NCT02028169|Primary|WPAI Questionnaire: Mean Percentage of Overall Work Productivity Impairment (OWPI) Due to PsA Up to Month 9|The mean percentage of OWPI due to PsA (based on the WPAI questionnaire) is presented, calculated as: Absenteeism (%) +[1- Absenteeism(%)*Presenteeism(%)]. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.|Baseline, Month 3, Month 6, Month 9|Participants with an assessment at given time point.||percentage of OWPI||Standard Deviation|Mean
651517|NCT02028169|Primary|WPAI Questionnaire: Mean Percentage of Impairment While Working Due to PsA (Presenteeism) Up to Month 9|Presenteeism (the extent to which PsA decreased productivity) is presented as the mean percentage of impairment while working due to PsA, and calculated as: 100*scale value of question 5 on the WPAI (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.|Baseline, Month 3, Month 6, Month 9|Participants with an assessment at given time point.||percentage of impairment while working||Standard Deviation|Mean
651518|NCT02028169|Primary|Work Productivity and Activity Impairment (WPAI) Questionnaire: Mean Percentage of Work Time Missed (Absenteeism) Up to Month 9|Absenteeism, presented as the mean percentage of work time missed due to PsA (as reported on the WPAI), and calculated as: 100*number of hours of work missed due to PsA / (number of hours of work missed due to PsA + number of hours worked). WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.|Baseline, Month 3, Month 6, Month 9|Participants with an assessment at given time point.||percentage of work time missed||Standard Deviation|Mean
651519|NCT02028065|Secondary|Percentage of Participants With Adjudicated Anaphylaxis|The investigator or designated clinician performed a THA in each participant at 0.5, 4 and 24 hours after each dose. The THA could also be performed at other times if possible hypersensitivity signs were observed. Each potential hypersensitivity case identified by presence of any sign or symptom in a pre-defined list of hypersensitivity signs and symptoms that were found through the THA was reviewed by an independent, blinded adjudication committee, which determined whether the referred case was a case of anaphylaxis (yes/no) using Sampson Criterion 1 - Acute onset of an illness with involvement of the skin, mucosal tissue or both, and at least one of the following: a) respiratory compromise, b) reduced blood pressure or associated symptoms of end-organ dysfunction (J Allergy Clin Immunol 2006;117:391-397). All AEs occurring in study were reviewed for terms associated with hypersensitivity or anaphylaxis, and could also result in referral to the adjudication committee for evaluation.|Up to approximately 28 days after last dose (approximately 14 weeks)|APaT - All randomized participants who received at least one dose of study treatment, with each participant included in arm corresponding to treatment actually received.||percentage of participants||95% Confidence Interval|Number
651535|NCT02026453|Secondary|Mean Severity-Weighted Admission Medication Order (AMO) Error Score|The severity-weighted admission medication order (AMO) error score are weighted error counts. Significant, serious, and life-threatening errors count for 1, 4, and 9 points each, respectively. Higher scores indicate either more errors or errors of greater severity. The range includes integers starting with 0 (indicating zero errors) up to infinity. For each AMH error identified, two physicians independently reviewed the relevant medications ordered at hospital admission in the context of the clinical chart. They classified each AMH error as either resulting in no AMO error, or an AMO error of significant, serious, or life-threatening severity. A third physician adjudicated disagreements. In cases where the admitting physician's knowledge of an AMH error was unclear and the orders clinically reasonable, we determined the AMH error did not lead to any AMO error. Because reviewers needed chart access to determine error severity, there was no practicable way to mask study arm.|Attempted to obtain the day after admission|||Mean Severity-Weighted AMO Error Score||95% Confidence Interval|Mean
651520|NCT02028065|Primary|Percentage of Participants With Adjudicated Symptoms of Hypersensitivity|The investigator or designated clinician performed a targeted hypersensitivity assessment (THA) in each participant at 0.5, 4 and 24 hours after each dose for each dosing period. The THA could also be performed at other times if possible hypersensitivity signs were observed. The THA included elicitation of symptoms as well as examination of the participant, covering neurologic, pulmonary, cardiovascular, gastrointestinal and dermatologic domains. Each potential hypersensitivity case identified by the presence of any sign or symptom in a pre-defined list of hypersensitivity signs and symptoms that were found through the THA was reviewed by an independent, blinded adjudication committee, which determined whether the referred case was a case of hypersensitivity (yes/no). In addition, all adverse events (AEs) occurring in study were reviewed for terms associated with hypersensitivity or anaphylaxis, and could also result in referral to the adjudication committee for evaluation.|Up to approximately 28 days after last dose (approximately 14 weeks)|APaT - All randomized participants who received at least one dose of study treatment, with each participant included in arm corresponding to treatment actually received.||percentage of participants||95% Confidence Interval|Number
651521|NCT02027883|Other Pre-specified|Safety Monitoring|Number of participants that were monitored for safety issues, including increased heart rate, blood pressure, decreased oximetry levels, and stable rhythm during the entire procedure.|2 hours|||participants|||Number
651522|NCT02027883|Secondary|Factors|Determine if any pre-implant patient demographics are factors impacting T-shock success according to parameter settings.|2 hours|||participants|||Number
651523|NCT02027883|Primary|Sustained Ventricular Fibrillation|The primary endpoint is the successful induction of sustained ventricular fibrillation.|2 hours|||participants|||Number
651524|NCT02027844|Other Pre-specified|Postoperative Behavioral Changes|"The investigators measure negative postoperative behavioral change of children after discharge of postanesthetic care unit using posthospital behavioral questionnaires( PHBQ ) at postoperative day (POD) 1 by visiting and followed at POD 14 by phone interview.
The PHBQ consists of 27 items concerning sleep, eating, anxiety, aggressive behaviour, etc.
The subscales were: general anxiety and regression, separation anxiety, anxiety about sleep, eating disturbance, aggression towards authority, and withdrawal.
Negative behavior change was evaluated in 6 subscales categories. If more than one negative behavior change developed, the investigators calculated number of children who developed new-onset negative behavior change."|1. postoperative 2 days, 2 postoperative 14 days|If more than one negative behavior change in children developed, the investigators calculated number of the children who developed new-onset negative behavior change.||participants|||Number
651525|NCT02027844|Other Pre-specified|Postoperative Emergence Delirium|"The investigators measure postoperative emergence delirium of children after recovery of anesthesia using Children's Hospital of Eastern Ontario Pain(CHEOP) Scale at 20 minute in postanesthetic care unit
The CHEOPS (Children's Hospital of Eastern Ontario Pain Scale) is a behavioral scale for evaluating postoperative pain in young children. It can be used to monitor the effectiveness of interventions for reducing the pain and discomfort.
CHEOPS pain score = SUM(points for all 6 parameters) : Cry, facila, Child verbal, Torso, Touch, legs
Interpretation:
minimum score: 4 = no pain
maximum score: 13 = the worst pain
When the highest CHEOPS score recorded at any time exceeded 10, emergence delirium was deemed to be present."|at 20 minute in postanesthetic care unit|When the highest CHEOPS score recorded at any time exceeded 10, emergence delirium was deemed to be present.||participants|||Number
651526|NCT02027844|Secondary|Change From Baseline Parental Anxiety at Postinduction of Anesthesia|"The investigators measure change of parental anxiety using State-Trait Anxiety Inventory (STAI)
The State-Trait Anxiety Inventory (STAI) is a psychological inventory and consists of 40 questions on a self-report basis.
The STAI measures two types of anxiety - state anxiety, or anxiety about an event, and trait anxiety, or anxiety level as a personal characteristic.
Higher scores are positively correlated with higher levels of anxiety.
Each type of anxiety has its own scale of 20 different questions that are scored.
Scores range from 20 to 80, with higher scores correlating with greater anxiety."|1. baseline: 15 minute after arrival at preoperative holding area before induction of anesthesia 2. postinduction : after induction of anesthesia|||units on a scale||Inter-Quartile Range|Median
651527|NCT02027844|Primary|Modified Yale Preoperative Anxiety Scale Scores at Baseline, Arrival in Operating Room, and Inhalation Induction|"The investigators measure change in anxiety of children using Modified Yale Preoperative Anxiety scale (m-YPAS): Scale changes from Activities, Vocalization, Expressing emotions, State of arousal, Interaction with family members.
Each domain received a partial score based on the punctuation observed divided by the number of categories of that domain. The score of each domain is added to the others
Total scores ranged from 23.4 to 100 The scores considered “cut points” to determine whether a patient had/had not anxiety were 23
Without anxiety: 23.4 e 30
With anxiety: greater than 30."|1. baseline (10 minute after arrival in the preoperative holding area) 2. on arrival in the operating room, 3. during inhalational induction with sevoflurane|||units on a scale||Inter-Quartile Range|Median
651528|NCT02027402|Secondary|Postoperative Pain Score|Postoperative pain was estimated using the visual analog scale (VAS) from 0 (no pain) to 10 (worst pain imaginable) at 6, 24, and 48 hours after the operation.|6hr after operation - 24hr after operation - 48hr after operation|||units on a scale||Standard Deviation|Mean
651529|NCT02027402|Secondary|Postoperative Hospital Stay||2weeks|||day||Standard Deviation|Mean
651530|NCT02027402|Secondary|Operative Time||1day|||minutes||Standard Deviation|Mean
651531|NCT02027402|Primary|Complication|complication is subhepatic fluid collection with abscess or subhepatic hematoma or bile leakage.|2 weeks|||participants|||Number
651532|NCT02027311|Secondary|Event of Hypoxia|Hypoxia defined as peripheral blood oxygen saturation measured by pulse oxymeter < 90%|Every 5min in Preoperative, intraoperative phase and 15 min in Recovery phase|||Hypoxia events|||Number
651533|NCT02027311|Primary|Number of Intervention|The frequency of intervention which was defined as any restraint of the patient’s head, arms, or legs if they became agitated, or if patient movement was not controlled with verbal instruction from the endoscopist during the whole intraoperative phases.|Throughout the whole ERCP procedure|||Number of intervention||Standard Deviation|Mean
651534|NCT02027272|Primary|Eclampsia and Posterior Reversible Encephalopathy Syndrome (PRES): Arandomized Clinical Trial Evaluating Corticosteroid Efficacy to Augment Standard Therapy and Shorten Recovery|To learn if giving IV dexamethasone to eclamptic women with PRES will accelerate normalization of CNS function.|36 months|Logistic hurdles caused to stop the study after the first participant and not proceed further. No analysis was undertaken.|||||
651536|NCT02026453|Primary|Mean Severity-weighted Admission Medication History (AMH) Error Score|The primary outcome was severity-weighted mean admission medication history (AMH) error score which are weighted error counts. Significant, serious, and life-threatening errors count for 1, 4, and 9 points each, respectively. As such, higher scores indicate either more errors or errors of greater severity. The range includes integers starting with 0 (indicating zero errors) up to infinity. To detect AMH errors, all patients received reference standard AMHs, which were compared with intervention and control group AMHs. AMH errors and resultant AMO errors were independently identified and rated by ≥2 investigators as significant, serious or life-threatening.|Attempted to obtain the day after admission|||Mean Severity-weighted AMH Error Score||95% Confidence Interval|Mean
651537|NCT02026258|Secondary|Questionnaire Involving Pain Management and Satisfaction With the Procedure|"Binomial measurement in questionnaire on medications taken and satisfaction with the procedure
Did you take any pain medication after the procedure? Y/N (Count Yes)
Would you undergo this procedure again? Y/N (Count Yes)
Would you recommend this procedure to a friend? Y/N (Count Yes)"|4-5 weeks after first wire placement|||Participants|||Count of Participants
651538|NCT02026258|Secondary|Questionnaire on Easiness and Satisfaction With the Procedure|"Visual analogue Scale from 0-100
Are you satisfied with your treatment? Very- Not Satisfied (0-100)
How easy was the procedure to you? Easy-Complicated (0-100)"|4-5 weeks after first wire placement|||units on a scale||Standard Deviation|Mean
651539|NCT02026258|Secondary|Questionnaires Involving Pain Level|"Specific questions questionnaire included:
1) How much pain/discomfort at the following time points? 1) Immediately after first wire placement (T0), 2) 1 hour, (T1) 3) 12 hrs (T2) and 4) Seven days after (T3). Rated on a scale from 0-100 (No pain-Unbearable pain)"|Immediate to 1 week after wire placement (T0-T3)|||units on a scale||Standard Deviation|Mean
651540|NCT02026258|Primary|Number of Days to Complete Alignment of Mandibular Anterior Teeth Based on Little's Irregularity Index|Days until complete alignment of mandibular anterior alignment was achieved after wire insertion on both groups. Complete alignment was based on Little's Irregularity index (Sum of contact displacement in mm between the anterior teeth from mesial of one canine to the mesial of the contralateral canine) of less than 2mm.|From the placement of the first wire to complete alignment of mandibular anteiror teeth, assessed up to 9 months|||Days to complete alignment||Standard Deviation|Mean
651541|NCT02026206|Secondary|Quality of Life|The secondary outcome measures were quality of life as assessed by the EQ-5D (minimun 0.00, maximum 1.00). The EQ-5D descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. The subscales combined to compute a total score according to EQ-5D equation formula. The higher values represent a better outcome.All data collected by self-reported sheet. Before treatment, the participants conducted a self-evaluation of pain intensity and quality of life after the next menstruation started (pre-treatment score) using the EQ-5D questionnaire. After self-therapy on 3 menstrual cycles, the participants conducted a self-evaluation of quality of life after the next menstruation started (post-treatment score) using the EQ-5D questionnaire.|within 3 months after treatment|||units on a scale||Standard Deviation|Mean
651542|NCT02026206|Primary|Dysmenorrheal Pain Severity|The primary outcome was menstrual pain intensity described using a 0-10 VAS scale (minimum 0, maximum 10). The higher values represent a worse outcome. All data collected by self-reported sheet. Before treatment, the participants conducted a self-evaluation of pain intensity after the next menstruation started (pre-treatment score) using the VAS. After self-therapy on 3 menstrual cycles, the participants conducted a self-evaluation of pain intensity after the next menstruation started (post-treatment score) using the VAS.|within 3 months after treatment|||units on a scale||Standard Deviation|Mean
651543|NCT02026193|Primary|Fetal Heart Activity 1 Month Post Embryo Transfer|Fetal heart activity as demonsrated by vaginal ultrasound 1 month post embryo transfer|1 month after embryo transfer|||participants with fetal heart activity|||Number
651544|NCT02026141|Other Pre-specified|VAS Scores|Patients will be asked to chart their VAS pain score at the 6, 12 , and 24 hour mark.|6, 12 and 24 hour marks.||||||
651545|NCT02026141|Secondary|Time of First Analgesia Request||time of first analgesia request from closure of skin up to 24 hours.||||||
651546|NCT02026141|Primary|Morphine Consumption|Patients will be provided with a patient-controlled-analgesia in which they will have morphine available for pain scores greater than 3.|24 hours|||milligrams||Standard Deviation|Mean
651547|NCT02025907|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) at Week 26||Baseline and Week 26|mITT population included all randomized participants who received at least 1 dose of double-blind study drug. A total of 3 participants were excluded from the mITT population due to potential misconduct and GCP compliance issues. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||millimeter of mercury (mmHg)||Standard Error|Least Squares Mean
651548|NCT02025907|Secondary|Percentage of Participants With HbA1c Less Than (<) 7.0 Percent at Week 26||Week 26|mITT population included all randomized participants who received at least 1 dose of double-blind study drug. A total of 3 participants were excluded from the mITT population due to potential misconduct and GCP compliance issues. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||percentage of participants|||Number
651549|NCT02025907|Secondary|Percent Change From Baseline in Body Weight at Week 26||Baseline and Week 26|mITT population included all randomized participants who received at least 1 dose of double-blind study drug. A total of 3 participants were excluded from the mITT population due to potential misconduct and GCP compliance issues. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||percent change||Standard Error|Least Squares Mean
651550|NCT02025907|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26||Baseline and Week 26|mITT population included all randomized participants who received at least 1 dose of double-blind study drug. A total of 3 participants were excluded from the mITT population due to potential misconduct and GCP compliance issues. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||millimoles per liter||Standard Error|Least Squares Mean
651686|NCT02023125|Secondary|AUClast of RO5468924: Group 2|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). RO5468924 is M4 metabolite of alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment period|PK Analysis Population [Group 2]||h*ng/mL||Standard Deviation|Mean
651551|NCT02025907|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26||Baseline and Week 26|mITT population included all randomized participants who received at least 1 dose of double-blind study drug. A total of 3 participants were excluded from the mITT population due to potential misconduct and GCP compliance issues. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
651552|NCT02025829|Secondary|Sputum Inflammatory Mediators: IL-1β, IL-6, IL-8, IL-17A, and Neutrophil Elastase|In the Exacerbation/IV Antibiotics Cohort--Measurement of sputum inflammatory mediators by multiplex assay for IL-1β, IL-6, IL-8, and IL-17A. Neutrophil elastase determined by colorimetric assay. Measurements at the beginning of IV antibiotic treatment and after 2 weeks antibiotic treatment for a pulmonary exacerbation|End of Treatment, two weeks. Samples will be obtained from each study volunteer at the beginning of IV antibiotic treatment and at the completion of antibiotic treatment for a pulmonary exacerbation|||pg/ml||Standard Deviation|Mean
651553|NCT02025829|Secondary|Sputum Inflammatory Mediators: IL-1β, IL-6, IL-8, IL-17A, TGF-β, TNF-α, and Neutrophil Elastase|In the Clinically Stable Cohort--Measurement of sputum inflammatory mediators: IL-1β, IL-6, IL-8, IL-17A, TGF-β, TNF-α, and neutrophil elastase|Samples will be obtained at one outpatient clinic visit during the next calendar year|Data not collected and will never be analyzed.|||||
651554|NCT02025829|Primary|Change in Sputum IL-17 Neutrophils|In the Exacerbation/IV Antibiotics Cohort--Subjects will serve as their own controls. The percentage of neutrophils (in sputum) positive for IL-17 was determined by flow cytometry for each subject at the beginning and end of treatment for a pulmonary exacerbation. Sputum IL-17 neutrophil counts will be compared to the change in lung function (FEV1) as determined by spirometry (American Thoracic Society standards).|End of Treatment, two weeks. Samples will be obtained from each study volunteer at the beginning of IV antibiotic treatment and at the completion of antibiotic treatment for a pulmonary exacerbation|"Regarding Clinically Stable Arm: Because very few neutrophils at the end of treatment for a pulmonary exacerbation were positive for IL-17, it was determined not to undertake studies examining sputum neutrophils during periods of clinical stability."||% of neutrophils positive for IL-17||Standard Deviation|Mean
651555|NCT02025647|Post-Hoc|Mental Health Prevalence Rates Comparison|"What is the percentage of subjects where the provider was unaware of any mental health concerns yet Innerview identified them as having hit a rule out or diagnostic consideration for a mental health disorder vs the US 12 Month Prevalence Rate?
US 12 Month Prevalence Rate = 26.2% (http://www.ncbi.nlm.nih.gov/pubmed/15939839)"|Study Duration|104 subjects had no known mental health concerns||percentage of subjects|||Number
651556|NCT02025647|Other Pre-specified|Completion Times|On average, the number of minutes taken to complete both the narrative and rating modules?|Study Duration|||minutes||Inter-Quartile Range|Median
651557|NCT02025647|Secondary|Subject Survey (Question 10)|It took an acceptable amount of time to tell my story. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree|Immediate|||units on a scale||Standard Deviation|Mean
651558|NCT02025647|Secondary|Subject Survey (Question 9)|The demonstration showed me how to use the system. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree|Immediate|||units on a scale||Standard Deviation|Mean
651559|NCT02025647|Secondary|Subject Survey (Question 8)|Telling my story helped me prepare for treatment. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree|Immediate|||units on a scale||Standard Deviation|Mean
651560|NCT02025647|Secondary|Subject Survey (Question 7)|Q7. I would encourage other doctors to use this system. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree|Immediate|||units on a scale||Standard Deviation|Mean
651561|NCT02025647|Secondary|Subject Survey (Question 6)|"I was able to select words and phrases that I normally use to talk about my symptoms.
Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree"|Immediate|||units on a scale||Standard Deviation|Mean
651562|NCT02025647|Secondary|Subject Survey (Question 5)|The program included all of the symptoms I wanted to share with my doctor. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree|Immediate|||units on a scale||Standard Deviation|Mean
651563|NCT02025647|Secondary|Subject Survey (Question 4)|This tool will contribute positively to my health care. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree|Immediate|||units on a scale||Standard Deviation|Mean
651564|NCT02025647|Secondary|Subject Survey (Question 3)|The program was easy to use. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree|Immediate|||units on a scale||Standard Deviation|Mean
651565|NCT02025647|Secondary|Subject Survey (Question 2)|"Compared to other health care questionnaires I have taken, I would rate this system highly.
Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree"|Immediate|||units on a scale||Standard Deviation|Mean
651566|NCT02025647|Secondary|Subject Survey (Question 1)|I am satisfied with how I was able to tell my story. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree|Immediate|||units on a scale||Standard Deviation|Mean
651567|NCT02025647|Secondary|Provider Survey (Question 11)|On average, how much extra time do you estimate that you spent with your patients evaluating and discussing the information collected through Innerview?|Administered Innerview session on at least 15 subjects|This is an investigator survey meant to measure the usefullness, feasibility and acceptability of the tool. Therefore, this question was not asked of the subjects but of their providers. There were a total of 6 providers/investigators that enrolled 15 or more subjects.||minutes||Full Range|Mean
651568|NCT02025647|Secondary|Provider Survey (Question 10)|The benefits of Innerview will outweigh the effort to implement and operate it. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree|Administered Innerview session on at least 15 subjects|This is an investigator survey meant to measure the usefullness, feasibility and acceptability of the tool. Therefore, this question was not asked of the subjects but of their providers. There were a total of 6 providers/investigators that enrolled 15 or more subjects.||units on a scale||Full Range|Mean
651623|NCT02024698|Primary|Handling (Subjective Assessment)|Subjective Assessment: Handling on Insertion and Removal, Overall Handling for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very difficult, 10=very easy)|1 Week|One participant received etafilcon A twice which explains the uneven number of participants analyzed in the study results for week 1.||units on a scale||Standard Deviation|Mean
651569|NCT02025647|Secondary|Provider Survey (Question 9)|In my opinion, incorporating Innerview into my practice would require an acceptable amount of time and effort from myself and staff Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree|Administered Innerview session on at least 15 subjects|This is an investigator survey meant to measure the usefullness, feasibility and acceptability of the tool. Therefore, this question was not asked of the subjects but of their providers. There were a total of 6 providers/investigators that enrolled 15 or more subjects.||units on a scale||Full Range|Mean
651570|NCT02025647|Secondary|Provider Survey (Question 8)|My patients reacted positively to Innerview. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree|Administered Innerview session on at least 15 subjects|This is an investigator survey meant to measure the usefullness, feasibility and acceptability of the tool. Therefore, this question was not asked of the subjects but of their providers. There were a total of 6 providers/investigators that enrolled 15 or more subjects.||units on a scale||Full Range|Mean
651571|NCT02025647|Secondary|Provider Survey (Question 7)|Innerview will function well within my current work flow Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree|Administered Innerview session on at least 15 subjects|This is an investigator survey meant to measure the usefullness, feasibility and acceptability of the tool. Therefore, this question was not asked of the subjects but of their providers. There were a total of 6 providers/investigators that enrolled 15 or more subjects, one investigator did not respond to this item.||units on a scale||Full Range|Mean
651572|NCT02025647|Secondary|Provider Survey (Question 6)|"Innerview will help me better identify patients who suffer from a mental health concern.
Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree"|Administered Innerview session on at least 15 subjects|This is an investigator survey meant to measure the usefullness, feasibility and acceptability of the tool. Therefore, this question was not asked of the subjects but of their providers. There were a total of 6 providers/investigators that enrolled 15 or more subjects.||units on a scale||Full Range|Mean
651573|NCT02025647|Secondary|Provider Survey (Question 5)|"In my opinion, the Innerview narrative process will help prepare patients for treatment.
Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree"|Administered Innerview session on at least 15 subjects|This is an investigator survey meant to measure the usefullness, feasibility and acceptability of the tool. Therefore, this question was not asked of the subjects but of their providers. There were a total of 6 providers/investigators that enrolled 15 or more subjects.||units on a scale||Full Range|Mean
651574|NCT02025647|Secondary|Provider Survey (Question 4)|The information provided by Innerview was well communicated in the reports. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree|Administered Innerview session on at least 15 subjects|This is an investigator survey meant to measure the usefullness, feasibility and acceptability of the tool. Therefore, this question was not asked of the subjects but of their providers. There were a total of 6 providers/investigators that enrolled 15 or more subjects.||units on a scale||Full Range|Mean
651575|NCT02025647|Secondary|Provider Survey (Question 3)|The information provided by Innerview was well organized in the reports. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree|Administered Innerview session on at least 15 subjects|This is an investigator survey meant to measure the usefullness, feasibility and acceptability of the tool. Therefore, this question was not asked of the subjects but of their providers. There were a total of 6 providers/investigators that enrolled 15 or more subjects.||units on a scale||Full Range|Mean
651576|NCT02025647|Secondary|Provider Survey (Question 2)|"The information provided by Innerview was consistent with my previous observations of my patients.
Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree"|Administered Innerview session on at least 15 subjects|This is an investigator survey meant to measure the usefullness, feasibility and acceptability of the tool. Therefore, this question was not asked of the subjects but of their providers. There were a total of 6 providers/investigators that enrolled 15 or more subjects.||units on a scale||Full Range|Mean
651577|NCT02025647|Secondary|Provider Survey (Question 1)|"The information provided by Innerview is valuable in understanding and treating my patients.
Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree"|Administered Innerview session on at least 15 subjects|This is an investigator survey meant to measure the usefullness, feasibility and acceptability of the tool. Therefore, this question was not asked of the subjects but of their providers. There were a total of 6 providers/investigators that enrolled 15 or more subjects.||units on a scale||Full Range|Mean
651578|NCT02025647|Primary|Standard Error of Measure for the Individualized Rating Scale (Rating Module)|What is the standard error of measurement (SEM) for test/retest symptom ratings on a 0 - 10 point scale|approximate 5 minutes between ratings|||units on a scale|||Number
651579|NCT02025647|Primary|Reliability of the Narrative Module|What is the consistency of the diagnostic criteria generated by two administrations, 1 to 2 days apart?|24-48 hours|||percentage of agreement||Standard Deviation|Mean
651580|NCT02025647|Primary|Accuracy of the Narrative Module|Out of 139 subjects using Innerview for the first time, how many subjects approved their initial version of their narrative versus chose to start over?|Immediate|||participants|||Number
651581|NCT02025075|Secondary|Postoperative Pain|The patient will be inquired about pain with a visual analogue scale (VAS). Pain will be evaluated as incisional pain using VAS (0 = no pain; 100 = worst possible pain).|Postoperative Day 1|||units on a scale||Standard Deviation|Mean
651582|NCT02025075|Primary|Cerebral Oximetry (%)|Regional cerebral oxygenation will be assessed continuously during the intraoperative period using NIRS technology.|BL; During pneumoperitoneum; Stage w/2 depths neuromuscular blockade targeted - TOF1 and Deep: 1-2 twitches in post-tetanic count (50-Hz tetanus followed by three-second pause and 15 1-Hz stimuli); and immediately after release of pneumoperitoneum|||percent cerebral saturation||Standard Deviation|Mean
651583|NCT02025075|Primary|Ejection Fraction (%)|To assess cardiac performance, transthoracic echocardiography will be used. Ejection fraction was measured as fractional shortening (FS). FS is the fraction of any diastolic dimension that is lost in systole. FS = 100*(LVEDD - LVESD) / LVEDD, LVEDD = LV end-diastolic dimension (mm); LVESD = LV end-systolic dimension (mm).|BL; During pneumoperitoneum; Stage w/2 depths neuromuscular blockade targeted - TOF1 and Deep: 1-2 twitches in post-tetanic count (50-Hz tetanus followed by three-second pause and 15 1-Hz stimuli); and immediately after release of pneumoperitoneum|||% fractional shortening||Standard Deviation|Mean
651584|NCT02025075|Primary|Regional Change in Air Content (Delta Z, %)|We will measure continuous respiratory flows and pressures in the intraoperative period to assess continuously the compliance and resistance of the respiratory system (T1 to T5). In addition, we will use an esophageal balloon to assess esophageal pressures and partition the global mechanical properties of the respiratory system, into their lung and chest wall components (T1 to T5). Regional lung aeration will be assessed for quantification of intraoperative lung recruitment using Electrical Impedance Tomography (EIT) (T0 to T6). Percent change was calculated using electrical impedance measurements obtained at time T0 as reference.|BL; During pneumoperitoneum; Stage w/2 depths neuromuscular blockade targeted - TOF1 and Deep: 1-2 twitches in post-tetanic count (50-Hz tetanus followed by three-second pause and 15 1-Hz stimuli); and immediately after release of pneumoperitoneum|||percent change||Standard Deviation|Mean
651585|NCT02024971|Secondary|Change From Baseline in Fasting Insulin|Tabulation of fasting insulin test values and change at each test time point (test value at each test time point after baseline – test value at baseline). A negative change from Baseline indicates improvement. n=number of participants analyzed at each time point. Final assessment is defined as a cumulative assessment of Month 12 and Early Termination Visit data.|Baseline and Months 3, 6, 9, 12 and final assessment|The analysis was performed in the efficacy assessment population (n=905).||μU/dL||Standard Deviation|Mean
651586|NCT02024971|Secondary|Change From Baseline in Fasting Blood Glucose|Tabulation of fasting blood glucose test values and change at each test time point (test value at each test time point after baseline – test value at baseline). A negative change from Baseline indicates improvement. n=number of participants analyzed at each time point. Final assessment is defined as a cumulative assessment of Month 12 and Early Termination Visit data.|Baseline and Months 3, 6, 9, 12 and final assessment|The analysis was performed in the efficacy assessment population (n=905).||mg/dL||Standard Deviation|Mean
651587|NCT02024971|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|Tabulation of the HbA1c test value and change at each test time point (test value at each test time point after baseline – test value at baseline). A negative change from Baseline indicates improvement. n=number of participants analyzed at each time point. Final assessment is defined as a cumulative assessment of Month 12 and Early Termination Visit data.|Baseline and Months 3, 6, 9, 12 and final assessment|The analysis was performed in the efficacy assessment population (n=905).||percentage of HbA1c||Standard Deviation|Mean
651588|NCT02024971|Primary|Number of Participants With Adverse Drug Reactions|Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.|12 months|Safety Analysis Set, all patients for whom data was collected in case report forms, except those who were treated before the contract period, those who were enrolled after Day 15 of the start of treatment with Metact Combination Tablets, and those with missing data after treatment (missed visits).||participants|||Number
651589|NCT02024932|Secondary|Compare Dose Normalized Log-transformed AUCinf Following IV and SC Administrations|Serum samples were obtained for PK assessment.|In Part A: days 1 and 15, pre-dose, 1, 4, 12, 24, 48, 168 hours post-dose.|This PK parameter was not analyzed in either Part A or Part B because there were insufficient data points after Cmax. Therefore, this parameter could not be calculated.|||||
651590|NCT02024932|Secondary|Plasma Pharmacokinetics (PK) of BVS857: The Area Under the Serum Concentration-time Curve From Time Zero to Infinity (AUCinf)|Serum samples were obtained for PK assessment.|Part A: days 1, 15, 29, 43: pre-dose, 1, 4, 12, 24, 48, 168 hours post-dose. Day 57: pre-dose, 1, 4, 12, 24, 48, 168, 504 hours post-dose. Part B: days 1 and 36: pre-dose, 1, 4, 24, 48 hours post-dose. Day 78: pre-dose, 1, 4, 24, 48, 168 hours post-dose.|This PK parameter was not analyzed in either Part A or Part B because there were insufficient data points after Cmax. Therefore, this parameter could not be calculated.|||||
651591|NCT02024932|Secondary|Plasma Pharmacokinetics (PK) of BVS857: The Terminal Elimination Half-life (T1/2)|Serum samples were obtained for PK assessment.|Part A: days 1, 15, 29, 43: pre-dose, 1, 4, 12, 24, 48, 168 hours post-dose. Day 57: pre-dose, 1, 4, 12, 24, 48, 168, 504 hours post-dose. Part B: days 1 and 36: pre-dose, 1, 4, 24, 48 hours post-dose. Day 78: pre-dose, 1, 4, 24, 48, 168 hours post-dose.|This PK parameter was not analyzed in either Part A or Part B because there were insufficient data points after Cmax. Therefore, this parameter could not be calculated.|||||
651592|NCT02024932|Secondary|Plasma Pharmacokinetics (PK) of BVS857: The Area Under the Serum Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau)|Serum samples were obtained for PK assessment.|Part A: days 1, 15, 29, 43: pre-dose, 1, 4, 12, 24, 48, 168 hours post-dose. Day 57: pre-dose, 1, 4, 12, 24, 48, 168, 504 hours post-dose. Part B: days 1 and 36: pre-dose, 1, 4, 24, 48 hours post-dose. Day 78: pre-dose, 1, 4, 24, 48, 168 hours post-dose.|This PK parameter was not analyzed in either Part A or Part B because there were insufficient data points after Cmax. Therefore, this parameter could not be calculated.|||||
651593|NCT02024932|Secondary|Plasma Pharmacokinetics (PK) of BVS857:The Area Under the Plasma Concentration-time Curve From Zero to 48 Hours (AUC0_48h) in Part B, Cohort 5||Days 1 and 36: pre-dose, 1, 4, 24, 48 hours post-dose. Day 78: pre-dose, 1, 4, 24, 48, 168 hours post-dose.|For each time point, only participants from the PK set with valid measurements at that time point were analyzed. The PK analysis set included participants with at least one available valid PK concentration measurement who received any study drug and experienced no protocol deviations with relevant impact on PK data.||h*ng/mL||Standard Deviation|Mean
651594|NCT02024932|Secondary|Plasma Pharmacokinetics (PK) of BVS857:The Area Under the Plasma Concentration-time Curve From Zero to 48 Hours (AUC0_48h) in Part B, Cohort 4|Serum samples were obtained for the PK assessment.|Days 1: pre-dose, 1, 4, 24, 48 hours post-dose|The PK analysis set, which included participants with at least one available valid PK concentration measurement who received any study drug and experienced no protocol deviations with relevant impact on PK data, was analyzed.||H*ng/mL||Standard Deviation|Mean
651606|NCT02024932|Secondary|Plasma Pharmacokinetics (PK) of BVS857: Observed Maximum Concentration Following Drug Administration (Cmax) in Part A, Cohort 2|Serum samples were obtained for PK assessment.|Days 1, 15, 29, 43: pre-dose, 1, 4, 12, 24, 48, 168 hours post-dose. Day 57: pre-dose, 1, 4, 12, 24, 48, 168, 504 hours post-dose|For each time point, only participants from the PK set with valid measurements at that time point were analyzed. The PK analysis set included participants with at least one available valid PK concentration measurement who received any study drug and experienced no protocol deviations with relevant impact on PK data.||ng/mL||Standard Deviation|Mean
651595|NCT02024932|Secondary|Plasma Pharmacokinetics (PK) of BVS857: The Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) in Part B, Cohort 5|Serum samples were obtained for PK assessment.|Day 36: pre-dose, 1, 4, 24, 48 hours post-dose. Day 78: pre-dose, 1, 4, 24, 48, 168 hours post-dose.|For each time point, only participants from the PK set with valid measurements at that time point were analyzed. The PK analysis set included participants with at least one available valid PK concentration measurement who received any study drug and experienced no protocol deviations with relevant impact on PK data.||h*ng/mL||Standard Deviation|Mean
651596|NCT02024932|Secondary|Plasma Pharmacokinetics (PK) of BVS857: Time to Reach the Maximum Concentration After Drug Administration (Tmax) in Part B, Cohort 5|Serum samples were obtained for PK assessment.|Days 1 and 36: pre-dose, 1, 4, 24, 48 hours post-dose. Day 78: pre-dose, 1, 4, 24, 48, 168 hours post-dose.|For each time point, only participants from the PK set with valid measurements at that time point were analyzed. The PK analysis set included participants with at least one available valid PK concentration measurement who received any study drug and experienced no protocol deviations with relevant impact on PK data.||hours||Standard Deviation|Mean
651597|NCT02024932|Secondary|Plasma Pharmacokinetics (PK) of BVS857: Time to Reach the Maximum Concentration After Drug Administration (Tmax) in Part B, Cohort 4|Serum samples were obtained for PK assessment.|Days 1: pre-dose, 1, 4, 24, 48 hours post-dose|The PK analysis set, which included participants with at least one available valid PK concentration measurement who received any study drug and experienced no protocol deviations with relevant impact on PK data, was analyzed.||hours||Standard Deviation|Mean
651598|NCT02024932|Secondary|Plasma Pharmacokinetics (PK) of BVS857: Observed Maximum Concentration Following Drug Administration (Cmax) in Part B, Cohort 5|Serum samples were obtained for PK assessment.|Days 1 and 36: pre-dose, 1, 4, 24, 48 hours post-dose. Day 78: pre-dose, 1, 4, 24, 48, 168 hours post-dose.|For each time point, only participants from the PK set with valid measurements at that time point were analyzed. The PK analysis set included participants with at least one available valid PK concentration measurement who received any study drug and experienced no protocol deviations with relevant impact on PK data.||ng/mL||Standard Deviation|Mean
651599|NCT02024932|Secondary|Plasma Pharmacokinetics (PK) of BVS857: Observed Maximum Concentration Following Drug Administration (Cmax) in Part B, Cohort 4|Serum samples were obtained for PK assessment.|Days 1: pre-dose, 1, 4, 24, 48 hours post-dose|The PK analysis set, which included participants with at least one available valid PK concentration measurement who received any study drug and experienced no protocol deviations with relevant impact on PK data, was analyzed.||ng/mL||Standard Deviation|Mean
651600|NCT02024932|Secondary|Plasma Pharmacokinetics (PK) of BVS857: The Area Under the Plasma Concentration-time Curve From Zero to 48 Hours (AUC0_48h) in Part A, Cohort 2|Serum samples were obtained for PK assessment.|Days 1, 15, 29, 43: pre-dose, 1, 4, 12, 24, 48, 168 hours post-dose. Day 57: pre-dose, 1, 4, 12, 24, 48, 168, 504 hours post-dose|For each time point, only participants from the PK set with valid measurements at that time point were analyzed. The PK analysis set included participants with at least one available valid PK concentration measurement who received any study drug and experienced no protocol deviations with relevant impact on PK data.||h*ng/mL||Standard Deviation|Mean
651601|NCT02024932|Secondary|Plasma Pharmacokinetics (PK) of BVS857: The Area Under the Plasma Concentration-time Curve From Zero to 48 Hours (AUC0_48h) in Part A, Cohort 1|Serum samples were obtained for PK assessment.|Days 1, 15, 29, 43: pre-dose, 1, 4, 12, 24, 48, 168 hours post-dose|For each time point, only participants from the PK set with valid measurements at that time point were analyzed. The PK analysis set included participants with at least one available valid PK concentration measurement who received any study drug and experienced no protocol deviations with relevant impact on PK data.||h*ng/mL||Standard Deviation|Mean
651602|NCT02024932|Secondary|Plasma Pharmacokinetics (PK) of BVS857: The Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) in Part A, Cohort 2|Serum samples were obtained for PK assessment.|Days 1, 15, 29, 43: pre-dose, 1, 4, 12, 24, 48, 168 hours post-dose. Day 57: pre-dose, 1, 4, 12, 24, 48, 168, 504 hours post-dose|For each time point, only participants from the PK set with valid measurements at that time point were analyzed. The PK analysis set included participants with at least one available valid PK concentration measurement who received any study drug and experienced no protocol deviations with relevant impact on PK data.||H*ng/mL||Standard Deviation|Mean
651603|NCT02024932|Secondary|Plasma Pharmacokinetics (PK) of BVS857: The Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) in Part A, Cohort 1|Serum samples were obtained for PK assessment.|Days 1, 15, 29, 43: pre-dose, 1, 4, 12, 24, 48, 168 hours post-dose|For each time point, only participants from the PK set with valid measurements at that time point were analyzed. The PK analysis set included participants with at least one available valid PK concentration measurement who received any study drug and experienced no protocol deviations with relevant impact on PK data.||h*ng/mL||Standard Deviation|Mean
651604|NCT02024932|Secondary|Plasma Pharmacokinetics (PK) of BVS857: Time to Reach the Maximum Concentration After Drug Administration (Tmax) in Part A, Cohort 2|Serum samples were obtained for PK assessment.|Day 1, 15, 29, 43: pre-dose, 1, 4, 12, 24, 48, 168 hours post-dose. Day 57: pre-dose, 1, 4, 12, 24, 48, 168, 504 hours post-dose|For each time point, only participants from the PK set with valid measurements at that time point were analyzed. The PK analysis set included participants with at least one available valid PK concentration measurement who received any study drug and experienced no protocol deviations with relevant impact on PK data.||hours||Standard Deviation|Mean
651605|NCT02024932|Secondary|Plasma Pharmacokinetics (PK) of BVS857: Time to Reach the Maximum Concentration After Drug Administration (Tmax) in Part A, Cohort 1|Serum samples were obtained for PK assessment.|Days 1, 15, 29, 43: pre-dose, 1, 4, 12, 24, 48, 168 hours post-dose|For each time point, only participants from the PK set with valid measurements at that time point were analyzed. The PK analysis set included participants with at least one available valid PK concentration measurement who received any study drug and experienced no protocol deviations with relevant impact on PK data.||hours||Standard Deviation|Mean
651622|NCT02024698|Primary|Eye Whiteness/Redness (Subjective Assessment)|Subjective Assessment: Eye Whiteness/Redness for each pair using questionnaire and rated on subjective response scale. (0-10; 0= significant redness, 10=totally white)|1 Week|One participant received etafilcon A twice which explains the uneven number of participants analyzed in the study results for week 1.||units on a scale||Standard Deviation|Mean
651607|NCT02024932|Secondary|Plasma Pharmacokinetics (PK) of BVS857: Observed Maximum Concentration Following Drug Administration (Cmax) in Part A, Cohort 1|Serum samples were obtained for PK assessment.|Days 1, 15, 29, 43: pre-dose, 1, 4, 12, 24, 48, 168 hours post-dose|For each time point, only participants from the PK set with valid measurements at that time point were analyzed. The PK analysis set included participants with at least one available valid PK concentration measurement who received any study drug and experienced no protocol deviations with relevant impact on PK data.||ng/mL||Standard Deviation|Mean
651608|NCT02024932|Secondary|Mean Change From Baseline in Total Lean Body Mass (LBM) in Part B, Cohort 5|LBM was assessed by dual-energy X-ray (DXA) absorptiometry. A positive change from baseline indicate improvement.|Baseline, Day 85|The PD analysis set was considered for the analysis. However, only participants who had evaluable data at both baseline and day 85, were included in the analysis. The PD set included participants with evaluable PD data who received any study drug and had no protocol deviations with relevant impact on PD data.||kilograms||Standard Deviation|Mean
651609|NCT02024932|Secondary|Mean Change From Baseline in Score on the Adult Myopathy Assessment Tool (AMAT) in Part B, Cohort 5|The AMAT rated physical function and muscle endurance, with higher scores indicating better performance. The tool includes 7 timed functional tasks rated on a scale from 0 - 21 and 6 endurance tasks rated on a scale from 0 - 24. The range for the total score was from 0 (worst) to 45 (best). A positive change from baseline indicates improvement.|Baseline, Day 85|The PD set included, which included participants with evaluable PD data who received any study drug and had no protocol deviations with relevant impact on PD data, was analyzed.||score on a scale||Standard Deviation|Mean
651610|NCT02024932|Primary|Mean Percent Change From Baseline in Thigh Muscle Volume in Part B, Cohort 5|Thigh muscle volume was assessed by magnetic resonance imaging (MRI). Change from baseline was calculated from the ratio of the post-baseline mean value to the baseline mean value: [(Day 85/baseline) - 1)] x 100. A positive change from baseline indicates improvement.|Baseline, Day 85|The PD analysis set was considered for the analysis. However, only participants who had evaluable data at both baseline and day 85, were included in the analysis. The PD set included participants with evaluable PD data who received any study drug and had no protocol deviations with relevant impact on PD data.||Percent change||Standard Deviation|Mean
651611|NCT02024932|Primary|Number of Mild, Moderate and Severe Adverse Events as a Measure of Safety and Tolerability|Safety was monitored throughout the study.|After 78 days in Part A and after 85 days in Part B.|The safety analysis set, which included participants who received any study drug, was analyzed.||Participants|||Number
651612|NCT02024932|Primary|Number of Patients With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths as a Measure of Safety and Tolerability|Safety was monitored throughout the study.|After 78 days in Part A and after 85 days in Part B.|The safety analysis set, which included participants who received any study drug, was analyzed.||Participants|||Number
651613|NCT02024867|Secondary|Recurrent Skin Infections Among Patients Infected With Methicillin-Sensitive Staphylococcus Aureus|Rate of recurrent skin infection among follow-up responders 1 month after enrollment. Patients who were treatment failures were excluded from this analysis since they all received additional medical intervention that could affect the outcome measure.|1 month after surgical drainage|||participants|||Number
651614|NCT02024867|Secondary|Recurrent Skin Infections Among Patients Infected With Methicillin-Resistant Staphylococcus Aureus|Rate of recurrent skin infection among follow-up responders 1 month after enrollment. Patients who were treatment failures were excluded from this analysis since they all received additional medical intervention that could affect the outcome measure.|1 month after surgical drainage|||participants|||Number
651615|NCT02024867|Primary|Treatment Failures Among Patients Infected With Methicillin-Sensitive Staphylococcus Aureus|Treatment failures were defined as persistent or increased size of the original abscess requiring further medical or surgical intervention. Treatment cure was defined as no or minimal tenderness, erythema, fever, wound drainage, warmth, fluctuance or induration at the 10 to 14 day follow-up.|up to 2 weeks after surgical drainage|||participants|||Number
651616|NCT02024867|Primary|Treatment Failures Among Patients Infected With Methicillin-Resistant Staphylococcus Aureus|Treatment failures were defined as persistent or increased size of the original abscess requiring further medical or surgical intervention. Treatment cure was defined as no or minimal tenderness, erythema, fever, wound drainage, warmth, fluctuance or induration at the 10 to 14 day follow-up.|up to 2 weeks after surgical drainage|||participants|||Number
651617|NCT02024867|Secondary|Recurrent Skin Infections|Rate of recurrent skin infection among follow-up responders 1 month after enrollment. Patients who were treatment failures were excluded from this analysis since they all received additional medical intervention that could affect the outcome measure.|1 month after surgical drainage|||participants|||Number
651618|NCT02024867|Primary|Treatment Failures|Treatment failures were defined as persistent or increased size of the original abscess requiring further medical or surgical intervention. Treatment cure was defined as no or minimal tenderness, erythema, fever, wound drainage, warmth, fluctuance or induration at the 10 to 14 day follow-up.|up to 2 weeks after surgical drainage|||participants|||Number
651619|NCT02024724|Primary|The Proportion of Subjects Reporting at Least 50% Overall Pain Relief|The number of subjects reporting a minimum of 50% pain relief after receiving the injection.|2 weeks|Subjects reported percent relief at 2 weeks from receiving the ultrasound guided injection.||Participants|||Count of Participants
651620|NCT02024698|Primary|Overall Satisfaction for Lens|"Subjective Assessment: Satisfaction overall at 1 Week wear for each pair when asked Overall, how satisfied was the subject with the study lenses, during the last week, with regards to: Overall? (Likert 1-4; 1=completely satisfied, 2=somewhat satisfied, 3=somewhat dissatisfied, 4=completely dissatisfied)"|1 Week|One participant received etafilcon A twice which explains the uneven number of participants analyzed in the study results for week 1.||participants|||Number
651621|NCT02024698|Primary|Overall Sensation of Smoothness (Subjective Assessment)|"Subjective Assessment: Overall sensation of smoothness at 1 week wear for each pair when asked How would you rate the overall sensation of smoothness (deposit resistance) of the first study lenses, over the last week of wear? (Likert 1-5; 1=excellent, 2=good, 3=average, 4=below average, 5=poor)"|1 Week|One participant received etafilcon A twice which explains the uneven number of participants analyzed in the study results for week 1.||participants|||Number
651720|NCT02022670|Secondary|Baseline and Week 10 Plasma Nitrite Concentrations||Baseline (Week 0), Week 10|||micromolar||Standard Error|Mean
651624|NCT02024698|Primary|Dryness (Subjective Assessment)|Subjective Assessment: Dryness During Day, Dryness Prior to Removal, Overall Dryness for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very dry, 10=no dryness)|1 Week|One participant received etafilcon A twice which explains the uneven number of participants analyzed in the study results for week 1.||units on a scale||Standard Deviation|Mean
651625|NCT02024698|Primary|Vision Satisfaction (Subjective Assessment)|Subjective Assessment: Vision Satisfaction for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very unsatisfied, 10=very satisfied)|1 Week|One participant received etafilcon A twice which explains the uneven number of participants analyzed in the study results for week 1.||units on a scale||Standard Deviation|Mean
651626|NCT02024698|Primary|Vision Quality (Subjective Assessment)|Subjective Assessment: Visual quality on insertion at baseline for each pair using questionnaire and rated on subjective response scale (0-10; 0= clear vision, 10=perfectly sharp)|Baseline|||units on a scale||Standard Deviation|Mean
651627|NCT02024698|Primary|Hydration (Subjective Assessment)|Subjective Assessment: Initial Hydration, Hydration During Day, Hydration Prior to Removal for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very dehydrated, not hydrophilic, very dry, 10=very hydrated, ultra hydrophilic)|1 Week|One participant received etafilcon A twice which explains the uneven number of participants analyzed in the study results for week 1.||units on a scale||Standard Deviation|Mean
651628|NCT02024698|Primary|Hydration (Subjective Assessment)|Subjective Assessment of hydration on insertion at baseline for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very dehydrated, not hydrophilic, very dry, 10=very hydrated, ultra hydrophilic)|Baseline|||units on a scale||Standard Deviation|Mean
651629|NCT02024698|Primary|Comfort (Subjective Assessment)|Subjective Assessment: Insertion Comfort, Comfort During Day, Comfort Prior to Removal, Comfort Overall for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very uncomfortable, 10=cannot feel)|1 Week|One participant received etafilcon A twice which explains the uneven number of participants analyzed in the study results for week 1.||units on a scale||Standard Deviation|Mean
651630|NCT02024698|Primary|Comfort (Subjective Assessment)|Subjective Assessment of comfort on insertion at baseline for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very uncomfortable, 10=cannot feel)|Baseline|||units on a scale||Standard Deviation|Mean
651631|NCT02024386|Secondary|Cardiac Output|Arterial blood samples will be obtained before, during, and after the VO2max exercise test in the hypobaric chamber at a simulated altitude of 15,000 feet. Exercise level will be increased every 3 minutes until test termination criteria are achieved. Samples will be obtained during the fifth minute of rest prior to exercise, during the third minute of each exercise level (referred to as stage below) and during the fifth minute post exercise. Cardiac output (CO) will be calculated using the Fick Principle: CO = V̇O2/(CaO2 – Cv̄O2) where CaO2 and Cv̄O2 represent the arterial and mixed venous oxygen content, respectively. CaO2 and CvO2 will be determined from analysis of the arterial blood samples using an IL GEM 4000 analyzer. VO2 will be reported as the final 30 secon average value of each stage. Subjects in the Riociguat cohorts will be tested prior to receiving drug and 90 minutes after receiving drug (midway through a three hour rest period between altitude exposures).|At rest, every 3 minutes during the exercise test and 5 minutes after each exercise test|Not all subjects performed the same number of exercise stages to achieve VO2max.||L/min||Standard Deviation|Mean
651632|NCT02024386|Secondary|Mean Work Rate at Exhaustion|Subject work rates at exhaustion (in watts) will be continuously monitored using an ergometer (exercise bicycle) during the VO2max exercise test in the hypobaric chamber at a simulated altitude of 15,000 feet. Exercise level will be increased every 3 minutes until test termination criteria are achieved. Measurements will be obtained at rest, every 3 minutes during the exercise test (referred to as a stage below) and at 5 minutes post exercise. Results will be reported as a 30 second average. Subjects in the Riociguat cohorts will be tested prior to receiving drug and 90 minutes after receiving drug (midway through a three hour rest period between altitude exposures).|At rest, every 3 minutes during the exercise test and 5 minutes after each exercise test|Not all subjects performed the same number of exercise stages to achieve VO2max.||watts||Standard Deviation|Mean
651633|NCT02024386|Secondary|Mean Ventilation Rate|Subject ventilation rates will be monitored continuously using a multi-channel A/D converter (PowerLab™) connected to a personal computer, using Chart™ software (ADInstruments, Colorado Springs, CO) during the VO2max exercise test in the hypobaric chamber at a simulated altitude of 15,000 feet. Exercise level will be increased every 3 minutes until test termination criteria are achieved. Measurements will be obtained at rest, every 3 minutes during the exercise test (referred to as a stage below) and at 5 minutes post exercise. Results will be reported as a 30 second average. Subjects in the Riociguat cohorts will be tested prior to receiving drug and 90 minutes after receiving drug (midway through a three hour rest period between altitude exposures).|At rest, every 3 minutes during the exercise test and 5 minutes after each exercise test|Not all subjects performed the same number of exercise stages to achieve VO2max.||L/min||Standard Deviation|Mean
651634|NCT02024386|Secondary|Mean Arterial Oxygen Saturation (SaO2)|Subject arterial oxygen saturation (SaO2) will be periodically monitored at fixed intervals via arterial blood gas measurements during the VO2max exercise test in the hypobaric chamber at a simulated altitude of 15,000 feet. Measurements will be obtained at rest, every 3 minutes during the exercise test (referred to as a stage below) and at 5 minutes post exercise. Results will be reported as a 30 second average. Subjects in the Riociguat cohorts will be tested prior to receiving drug and 90 minutes after receiving drug (midway through a three hour rest period between altitude exposures).|At rest, every 3 minutes during the exercise test and 5 minutes after each exercise test|Not all subjects performed the same number of exercise stages to achieve VO2max.||% oxygen saturation||Standard Deviation|Mean
651635|NCT02024386|Secondary|Mean Radial Arterial Pressure|Subject systemic arterial pressures will be continuously monitored via radial artery catheterization during the VO2max exercise test in the hypobaric chamber at a simulated altitude of 15,000 feet. Exercise level will be increased every 3 minutes until test termination criteria are achieved. Measurements will be obtained at rest, every 3 minutes during the exercise test (referred to as a stage below) and at 5 minutes post exercise. Results will be reported as a 30 second average. Subjects in the Riociguat cohorts will be tested prior to receiving drug and 90 minutes after receiving drug (midway through a three hour rest period between altitude exposures).|At rest, every 3 minutes during the exercise test and 5 minutes after each exercise test|Not all subjects performed the same number of exercise stages to achieve VO2max.||mm Hg||Standard Deviation|Mean
651636|NCT02024386|Primary|Mean Pulmonary Artery Pressure|Subject pulmonary artery pressures will be continuously monitored during the VO2max exercise test in the hypobaric chamber at a simulated altitude of 15,000 feet. Exercise level will be increased every 3 minutes until test termination criteria are achieved. Measurements will be obtained at rest, every 3 minutes during the exercise test (referred to as a stage below) and at 5 minutes post exercise. Results will be reported as a 30 second average. Subjects in the Riociguat cohorts will be tested prior to receiving drug and 90 minutes after receiving drug (midway through a three hour rest period between altitude exposures).|At rest, every 3 minutes during the exercise test and 5 minutes after each exercise test|Not all subjects performed the same number of exercise stages to achieve VO2max.||mm Hg||Standard Deviation|Mean
651637|NCT02024165|Primary|Fetal Heart Rate Interpretability|The Fetal Heart Rate (or FHR) of the electrode sensor will be compared to the FHR of the ultrasound when both are compared to the FSE. Percentage of time that signals are interpretable will be compared between devices|2 hours|||percentage of time the signals are inter||Standard Deviation|Mean
651640|NCT02023918|Secondary|Lipolysis|Treatment with pegvisomant is expected to alter lipolysis. To assess this investigators will do fasting and steady state stable isotope measurements prior to treatment with pegvisomant and at day 28 after treatment with pegvisomant.|28 days|Ra glycerol reported||mg/kg/min||Standard Deviation|Mean
651641|NCT02023918|Primary|Insulin Sensitivity|"Investigators will measure insulin sensitivity via hyperinsulinemic euglycemic clamp prior to the initiation of the study medication and then again at the end of the 28 days to evaluate the effect of pegvisomant on insulin sensitivity and reported as HOMA-IR.
HOMA-IR was derived from fasting insulin and fasting glucose by the calculation: fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5"|28 days|Patients were compared after treatment to their own baseline||units on a scale||Standard Deviation|Mean
651642|NCT02023879|Secondary|Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.|From Baseline to Week 24|ITT population. Number of participants analyzed = participants of the ITT population with available data at specified time-points.||percent change||Standard Error|Least Squares Mean
651643|NCT02023879|Secondary|Percent Change From Baseline in Apo A-1 at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.|From Baseline to Week 24|ITT population. Number of participants analyzed = participants of the ITT population with available data at specified time-points.||percent change||Standard Error|Least Squares Mean
651644|NCT02023879|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from a multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.|From Baseline to Week 24|ITT population.||percent change||Standard Error|Mean
651645|NCT02023879|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from a multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.|From Baseline to Week 24|ITT population.||percent change||Standard Error|Mean
651646|NCT02023879|Secondary|Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.|From Baseline to Week 24|ITT population.||percent change||Standard Error|Least Squares Mean
651647|NCT02023879|Secondary|Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.|From Baseline to Week 24|ITT population.||percent change||Standard Error|Least Squares Mean
651648|NCT02023879|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from a multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|ITT population.||percent change||Standard Error|Mean
651649|NCT02023879|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from a multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.|From Baseline to Week 24|ITT population.||percent change||Standard Error|Mean
651650|NCT02023879|Secondary|Percentage of Participants Achieving Calculated LDL-C <70 mg/dL (<1.81 mmol/L) at Week 24 – On-treatment Analysis|Adjusted percentages at Week 24 from LOCF approach including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection).|From Baseline to Week 24|mITT population.||percentage of participants|||Number
651651|NCT02023879|Secondary|Percentage of Participants Achieving Calculated LDL-C< 70 mg/dL (<1.81 mmol/L) at Week 24 - ITT Analysis|Adjusted percentages at Week 24 from last observation carried forward (LOCF) approach including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|ITT population.||percentage of participants|||Number
655260|NCT01953328|Secondary|Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
651652|NCT02023879|Secondary|Percentage of Very High CV Risk Participants Achieving Calculated LDL-C< 70 mg/dL (<1.81 mmol/L) or Moderate or High CV Risk Participants Achieving Calculated LDL-C< 100 mg/dL (<2.59 mmol/L) at Week 24 – On-treatment Analysis|Adjusted percentages at Week 24 from multiple imputation approach including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection).|From Baseline to Week 24|mITT population.||percentage of participants|||Number
651653|NCT02023879|Secondary|Percentage of Very High Cardiovascular (CV) Risk Participants Achieving Calculated LDL-C <70 mg/dL (<1.81 mmol/L) or Moderate or High CV Risk Participants Achieving Calculated LDL-C <100 mg/dL (<2.59 mmol/L) at Week 24 - ITT Analysis|"Moderate CV risk: 10-year fatal cardiovascular disease (CVD) risk Systemic Coronary Risk Evaluation (SCORE) ≥1 and <5%.
High CV risk: 10-year fatal CVD risk SCORE ≥5% or moderate chronic kidney disease or type 1 or type 2 diabetes mellitus without target organ damage or familial hypercholesterolemia.
Very high CV risk: history of documented coronary heart disease, ischemic stroke, peripheral artery disease, transient ischemic attack, abdominal aortic aneurysm, or carotid artery occlusion >50% without symptoms; carotid endarterectomy or carotid artery stent procedure; renal artery stenosis, or renal artery stent procedure; or type 1 or type 2 diabetes mellitus with target organ damage.
Adjusted percentages at Week 24 were obtained from a multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were included."|From Baseline to Week 24|ITT population.||percentage of participants|||Number
651654|NCT02023879|Secondary|Percent Change From Baseline in Total-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.|From Baseline to Week 24|ITT population.||percent change||Standard Error|Least Squares Mean
651655|NCT02023879|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.|From Baseline to Week 24|ITT population.||percent change||Standard Error|Least Squares Mean
651656|NCT02023879|Secondary|Percent Change From Baseline in Apo B at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.|From Baseline to Week 24|ITT population. Number of participants analyzed = participants of the ITT population with available data at specified time-points.||percent change||Standard Error|Least Squares Mean
651657|NCT02023879|Secondary|Percent Change From Baseline in Total-C at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.|From Baseline to Week 24|ITT population.||percent change||Standard Error|Least Squares Mean
651658|NCT02023879|Secondary|Percent Change From Baseline in Non-HDL-C at Week 24 – On-treatment Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection).|From Baseline to Week 24|mITT population.||percent change||Standard Error|Least Squares Mean
651659|NCT02023879|Secondary|Percent Change From Baseline in Non-HDL-C at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.|From Baseline to Week 24|ITT population.||percent change||Standard Error|Least Squares Mean
651660|NCT02023879|Secondary|Percent Change From Baseline in Apo B at Week 24 – On-treatment Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection).|From Baseline to Week 24|mITT population. Number of participants analyzed = participants of the mITT population with available data at specified time-points.||percent change||Standard Error|Least Squares Mean
651661|NCT02023879|Secondary|Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.|From Baseline to Week 24|ITT population. Number of participants analyzed = participants of the ITT population with available data at specified time-points.||percent change||Standard Error|Least Squares Mean
651662|NCT02023879|Secondary|Percent Change From Baseline in Calculated LDL-C at Averaged Week 9 to 12 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection) and assigning a weight of 0.25 for Week 9, 10, 11 and 12 time points.|From Baseline to Week 24|mITT population.||percent change||Standard Error|Least Squares Mean
651663|NCT02023879|Secondary|Percent Change From Baseline in Calculated LDL-C to Averaged Weeks 9 to 12 – ITT- Analysis|Adjusted LS means and standard errors at Week 12 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment and assigning a weight of 0.25 for Week 9, 10, 11 and 12 time points.|From Baseline to Week 24|ITT population.||percent change||Standard Error|Least Squares Mean
651664|NCT02023879|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection).|From Baseline to Week 24|mITT population.||percent change||Standard Error|Least Squares Mean
651665|NCT02023879|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.|From Baseline to Week 24|ITT population.||percent change||Standard Error|Least Squares Mean
651666|NCT02023879|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection) (on-treatment analysis).|From Baseline to Week 24|Modified ITT (mITT) population that included all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.||percent change||Standard Error|Least Squares Mean
652457|NCT02007278|Secondary|Number of Patients With Incidence of Hypoglycemia|Hypoglycemia defined as Glycemia < 70 mg/dl|12 weeks|Analysis set includes all randomized patients excluding the ones who were prematurely withdrawn and the ones who have no data from visit 7 which required for comparison.||Patients|||Number
651667|NCT02023879|Primary|Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT Analysis)|Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were used in the model (ITT analysis).|From Baseline to Week 24|ITT population that included all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment.||percent change||Standard Error|Least Squares Mean
651668|NCT02023801|Post-Hoc|Subjects With Amenorrhea at 12 Months|Amenorrhea at 12 Months- Number of Subjects experiencing no menstrual bleeding|12 months|Protocol Intent-to-treat||participants|||Number
651669|NCT02023801|Secondary|Procedure Time|Procedure time defined as time from insertion of the Disposable Handpiece to the time of removal|< 1 hour|Subjects completing treatment||Minutes||Standard Deviation|Mean
651670|NCT02023801|Primary|Reduction in Menstrual Blood Loss to Normal Levels at 12 Months|Number of subjects in whom menstrual blood loss was reduced to normal or below normal levels at 12 months, as measured by a pictorial blood loss assessment chart (PBLAC) score of <=75.|12 Months|Protocol Intent-to-treat population (all subjects in whom the experimental device was attempted to be placed.)||participants|||Number
651671|NCT02023515|Secondary|Decrease in Stress|Stress was measured by the Perceived Stress Scale (PSS). This scale measures stress on a scale of 0 to 40 points. The results are reported as a total score on the scale. Higher numbers indicate more stress than lower numbers.|PSS change from baseline to 20 weeks|||units on a scale||90% Confidence Interval|Mean
651672|NCT02023515|Primary|Weight Loss|Weight change from baseline to 20 weeks|Weight change from baseline to 20 weeks|||kg||Standard Deviation|Mean
651673|NCT02023268|Primary|Global Ocular Staining (With Oxford Scale - Ranges : 0-15)|"Change from Baseline in the worse eye on Day 35 (decrease of Oxford score = better outcome)
Global Ocular Staining With the Oxford Scale measured surface damage to treated eyes(by T2762 or vismed)."|Baseline and Day 35|14 patients with major protocol deviations were excluded of the analysed population.||score on a scale||Standard Deviation|Mean
651674|NCT02023125|Secondary|Vz/F for Alectinib: Group 2|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vz/F is influenced by the fraction absorbed.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment period|PK Analysis Population [Group 2]||Liters||Standard Deviation|Mean
651675|NCT02023125|Secondary|Apparent Volume of Distribution (Vz/F) for Alectinib: Group 1|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vz/F is influenced by the fraction absorbed.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment arm|PK Analysis Population [Group 1]||Liters||Standard Deviation|Mean
651676|NCT02023125|Secondary|CL/F for Alectinib: Group 2|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment period|PK Analysis Population [Group 2]||L/h||Standard Deviation|Mean
651677|NCT02023125|Secondary|Apparent Oral Clearance (CL/F) for Alectinib: Group 1|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment arm|PK Analysis Population [Group 1]||Liters per hour (L/h)||Standard Deviation|Mean
651678|NCT02023125|Secondary|t1/2 of RO5468924: Group 2|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. RO5468924 is M4 metabolite of alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment period|PK Analysis Population [Group 2]||hours||Standard Deviation|Mean
651679|NCT02023125|Secondary|t1/2 of RO5468924: Group 1|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. RO5468924 is M4 metabolite of alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period|PK Analysis Population [Group 1]||hours||Standard Deviation|Mean
651680|NCT02023125|Secondary|t1/2 of Alectinib: Group 2|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment period|PK Analysis Population [Group 2]||hours||Standard Deviation|Mean
651681|NCT02023125|Secondary|Terminal Half-life (t1/2) of Alectinib: Group 1|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment arm|PK Analysis Population [Group 1]||hours||Standard Deviation|Mean
651682|NCT02023125|Secondary|Tmax of RO5468924: Group 2|RO5468924 is M4 metabolite of alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment period|PK Analysis Population [Group 2]||hours||Full Range|Median
651683|NCT02023125|Secondary|Tmax of RO5468924: Group 1|RO5468924 is M4 metabolite of alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment arm|PK Analysis Population [Group 1]||hours||Full Range|Median
651684|NCT02023125|Secondary|Tmax of Alectinib: Group 2||Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment period|PK Analysis Population [Group 2]||hours||Full Range|Median
651685|NCT02023125|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Alectinib: Group 1||Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment arm|PK Analysis Population [Group 1]||hours||Full Range|Median
652458|NCT02007278|Secondary|Change in HbA1c at Week 12 of Treatment in Comparison to HbA1c at Baseline||baseline, 12 weeks of treatment|Analysis set includes all randomized patients excluding the ones who were prematurely withdrawn and the ones who have confirmed non-concordant data||Percentage of glycosylated haemoglobin||Standard Deviation|Mean
651687|NCT02023125|Secondary|AUClast of RO5468924: Group 1|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). RO5468924 is M4 metabolite of alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment arm|PK Analysis Population [Group 1]||h*ng/mL||Standard Deviation|Mean
651688|NCT02023125|Secondary|AUClast of Alectinib: Group 2|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment period|PK Analysis Population [Group 2]||h*ng/mL||Standard Deviation|Mean
651689|NCT02023125|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Alectinib: Group 1|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment arm|PK Analysis Population [Group 1]||h*ng/mL||Standard Deviation|Mean
651690|NCT02023125|Secondary|Metabolite/Parent Ratio for AUC0-inf: Group 2|AUC (0-inf) = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0 - t) plus AUC (t - inf). RO5468924 is M4 metabolite of alectinib. The ratio is molecular weight adjusted.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment period|PK Analysis Population [Group 2]||ratio||Standard Deviation|Geometric Mean
651691|NCT02023125|Secondary|Metabolite/Parent Ratio for AUC0-inf: Group 1|AUC (0-inf) = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0 - t) plus AUC (t - inf). RO5468924 is M4 metabolite of alectinib. The ratio is molecular weight adjusted.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment arm|PK Analysis Population [Group 1]||ratio||Standard Deviation|Geometric Mean
651692|NCT02023125|Secondary|AUC0-inf of RO5468924: Group 2|AUC (0-inf) = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0 - t) plus AUC (t - inf). RO5468924 is M4 metabolite of alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment period|PK Analysis Population [Group 2]||h*ng/mL||Standard Deviation|Mean
651693|NCT02023125|Secondary|AUC0-inf of RO5468924: Group 1|AUC (0-inf) = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0 - t) plus AUC (t - inf). RO5468924 is M4 metabolite of alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment arm|PK Analysis Population [Group 1]||h*ng/mL||Standard Deviation|Mean
651694|NCT02023125|Secondary|Cmax of RO5468924: Group 2|RO5468924 is M4 metabolite of alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment period|PK Analysis Population [Group 2]||ng/mL||Standard Deviation|Mean
651695|NCT02023125|Secondary|Cmax of RO5468924: Group 1|RO5468924 is M4 metabolite of alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment arm|PK Analysis Population [Group 1]||ng/mL||Standard Deviation|Mean
651696|NCT02023125|Primary|AUC0-inf of Alectinib: Group 2|AUC (0-inf) = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0 - t) plus AUC (t - inf).|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment period|PK Analysis Population [Group 2]||h*ng/mL||Standard Deviation|Mean
651697|NCT02023125|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC0-inf) of Alectinib: Group 1|AUC (0-inf) = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0 - t) plus AUC (t - inf).|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment arm|PK Analysis Population [Group 1]||hours*nanograms per milliliter (h*ng/mL)||Standard Deviation|Mean
651698|NCT02023125|Primary|Cmax of Alectinib: Group 2||Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment period|PK Analysis Population [Group 2] consisted of all participants who received both scheduled doses of Alectinib, and provided adequate PK assessments.||ng/mL||Standard Deviation|Mean
651699|NCT02023125|Primary|Maximum Observed Plasma Concentration (Cmax) of Alectinib: Group 1||Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment arm|Pharmacokinetic (PK) Analysis Population [Group 1] consisted of all participants who received both scheduled doses of Alectinib, and provided adequate PK assessments.||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
651700|NCT02023112|Secondary|Percentage of Participants With Post-treatment Relapse Within Different Subpopulations|"The percentage of participants with relapse by post-treatment Week 12 in each treatment arm within the following subpopulations: noncirrhotic participants; noncirrhotic treatment-experienced (T-exp) participants; participants with compensated cirrhosis.
Relapse by post-treatment Week 12 was defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug for a participant with HCV RNA < LLOQ at the final treatment visit and who completed study treatment. Completion of treatment was defined as a study drug duration ≥ 77 days for the 12-week treatment arm or ≥ 105 days for the 16-week treatment arm."|within 12 weeks after the last dose of study drug|ITT population: all randomized participants who received at least 1 dose of study drug with HCV RNA < LLOQ at the final treatment visit who completed treatment; n=participants in given subpopulation.||percentage of participants|||Number
651701|NCT02023112|Secondary|Percentage of Participants in Each Treatment Arm With On-treatment Virologic Failure During the Treatment Period for Each Treatment Arm Within Different Subpopulations|"The percentage of participants with on-treatment virologic failure in each treatment arm within the following subpopulations: noncirrhotic participants; noncirrhotic treatment-experienced (T-exp) participants; participants with compensated cirrhosis.
On-treatment virologic failure was defined as rebound (confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase from nadir in HCV RNA [> 1 log10 IU/mL above nadir] at any time point during treatment) or failure to suppress HCV during treatment (all on-treatment values of HCV RNA ≥ LLOQ with at least 6 weeks of treatment)."|12 or 16 weeks (end of treatment period)|ITT population: all randomized participants who received at least 1 dose of study drug; n=participants in given subpopulation.||percentage of participants|||Number
651702|NCT02023112|Secondary|Percentage of Participants With SVR12 Weeks Post-treatment for Each Treatment Arm Within Different Subpopulations|The percentage of participants with SVR12 in each treatment arm within the following subpopulations: noncirrhotic participants; noncirrhotic treatment-experienced (T-exp) participants; noncirrhotic participants who relapsed after prior IFN-based therapy (relapsers); noncirrhotic T-exp participants who were non-responders to prior IFN-based therapy; noncirrhotic T-exp participants who were intolerant to IFN-based therapy; participants with compensated cirrhosis.|12 weeks after last dose of study drug|ITT population: all randomized participants who received at least 1 dose of study drug; n=participants in given subpopulation.||percentage of participants||95% Confidence Interval|Number
651703|NCT02023112|Secondary|Percentage of Participants With Post-treatment Relapse|Relapse by post-treatment Week 12 was defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug for a participant with HCV RNA < LLOQ at the final treatment visit and who completed study treatment. Completion of treatment was defined as a study drug duration ≥ 77 days for the 12-week treatment arm or ≥ 105 days for the 16-week treatment arm.|within 12 weeks after the last dose of study drug|Primary efficacy population: all treatment-naïve, noncirrhotic participants in the ITT population (all randomized participants who received at least 1 dose of study drug) with HCV RNA < LLOQ at the final treatment visit who completed treatment.||percentage of participants|||Number
651704|NCT02023112|Secondary|Percentage of Participants in Each Treatment Arm With On-treatment Virologic Failure During the Treatment Period|On-treatment virologic failure was defined as rebound (confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase from nadir in HCV RNA [> 1 log10 IU/mL above nadir] at any time point during treatment) or failure to suppress HCV during treatment (all on-treatment values of HCV RNA ≥ LLOQ with at least 6 weeks of treatment).|12 or 16 weeks (end of treatment period)|Primary efficacy population: all treatment-naïve, noncirrhotic participants in the ITT population (all randomized participants who received at least 1 dose of study drug).||percentage of participants|||Number
651705|NCT02023112|Primary|Percentage of Non-cirrhotic, Treatment-naive Participants in Each Treatment Group With a Sustained Virologic Response 12 Weeks Post-treatment (SVR12)|The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after last dose of study drug|Primary efficacy population: all treatment-naïve, noncirrhotic participants in the intent-to-treat (ITT) population (all randomized participants who received at least 1 dose of study drug).||percentage of participants|||Number
651706|NCT02023099|Secondary|Percentage of Participants in Substudy 1 Arm A Active Treatment Group With Sustained Virologic Response 12 Weeks Post-Treatment, by Subpopulation|Sustained virologic response (plasma HCV RNA level < LLOQ) 12 weeks after the last dose of study drug for all randomized non-cirrhotic participants who received at least one dose of DB ABT-450/r/ABT-267 in the following subpopulations: noncirrhotic T-naïve participants with a high BL viral load (HCV RNA ≥ 100,000 IU/mL) who are eligible for IFN-BT; noncirrhotic T-naïve participants with low BL viral load (HCV RNA < 100,000 IU/mL); noncirrhotic T-naïve participants who are ineligible for IFN-BT; noncirrhotic T-exp participants who relapsed after prior IFN-BT; noncirrhotic T-exp participants who were nonresponders to prior IFN-BT; noncirrhotic T-exp participants who were intolerant to IFN-BT. The 95% confidence interval was calculated using the Wilson's score method.|12 weeks after last dose of study drug|ITT population: all randomized/enrolled participants who received at least 1 dose of active DB study drugs in Substudy 1 (Substudy 1 ITT population, Arm A); n=number of participants in the given subpopulation (among noncirrhotic participants, a single participant could potentially be included in more than 1 subpopulation).||percentage of participants||95% Confidence Interval|Number
651707|NCT02023099|Secondary|Percentage of Participants in the Active Treatment Group With Sustained Virologic Response 12 Weeks Post-treatment|Sustained virologic response (plasma HCV RNA level < LLOQ) 12 weeks after the last dose of study drug for all randomized non-cirrhotic participants who received at least one dose of DB ABT-450/r/ABT-267 and for all enrolled participants with compensated cirrhosis who received at least one dose of open-label ABT-450/r/ABT-267. The 95% confidence interval was calculated using the Wilson's score method.|12 weeks after last dose of study drug|ITT population: all randomized/enrolled participants who received at least 1 dose of DB study drugs in Substudy 1 (Substudy 1 ITT population) or at least 1 dose of OL study drugs in Substudy 2 (Substudy 2 ITT population).||percentage of participants||95% Confidence Interval|Number
651708|NCT02023099|Secondary|Percentage of Participants in Substudy 1 Arm A Active Treatment Group With Post-treatment Relapse, by Subpopulation|"Post-treatment relapse among all randomized non-cirrhotic participants who received at least one dose of DB ABT-450/r/ABT-267 and completed treatment, in the following subpopulations: noncirrhotic treatment-naïve (T-naïve) participants with a high baseline (BL) viral load (HCV RNA ≥ 100,000 IU/mL) who are eligible for IFN-based therapy (IFN-BT), a low BL viral load (HCV RNA < 100,000 IU/mL), or who are ineligible for IFN-BT; noncirrhotic treatment-experienced (T-exp) participants who relapsed after prior IFN-BT, who were nonresponders to prior IFN-BT, or who were intolerant to IFN-BT.
Relapse was defined as confirmed HCV RNA ≥ LLOQ (defined as 2 consecutive HCV RNA measurements ≥ LLOQ) between the final treatment visit and 12 weeks after the last dose of study drugs among participants completing treatment and with HCV RNA < LLOQ at the final treatment visit and at least one post-treatment HCV RNA value. The 95% confidence interval was calculated using the Wilson's score method."|within 12 weeks after last dose of study drug|ITT population: all randomized/enrolled participants who received at least 1 dose of active DB study drugs in Substudy 1 (Substudy 1 ITT population, Arm A) and completed treatment; n=number of participants in the given subpopulation (among noncirrhotic participants, a single participant could potentially be included in more than 1 subpopulation).||percentage of participants||95% Confidence Interval|Number
651721|NCT02022670|Primary|Baseline and Week 10 Flow-Mediated Dilation|Brachial artery flow mediated dilation (FMD) is assessed prior to entering the study. If subjects pass the inclusion requirements, FMD is analyzed at baseline and week 10. Flow-Mediated Dilation is calculated as the percent change in artery diameter in response to 5 minutes of cuff occlusion at Baseline and Week 10 timepoints; i.e. (Peak Diameter-Baseline Diameter)/Baseline Diameter x 100.|Baseline (Week 0), Week 10|||%Change||Standard Error|Mean
651722|NCT02022085|Secondary|Numbness|Degree of numbness when tested with a pin|Day 10, Week 4, Week 6, Week 12, Month 6|Safety population; includes all patients who received the surgical intervention.||percentage of total polulation|||Number
651709|NCT02023099|Secondary|Percentage of Participants in the Active Treatment Group With Post-treatment Relapse|Post-treatment relapse among all randomized non-cirrhotic participants who received at least one dose of DB ABT-450/r/ABT-267 and completed treatment, and all enrolled participants with compensated cirrhosis who received at least one dose of OL ABT-450/r/ABT-267 and completed treatment. Relapse was defined as confirmed HCV RNA ≥ LLOQ (defined as 2 consecutive HCV RNA measurements ≥ LLOQ) between the final treatment visit and 12 weeks after the last dose of study drugs among participants completing treatment and with HCV RNA < LLOQ at the final treatment visit and at least one post-treatment HCV RNA value. The 95% confidence interval was calculated using the Wilson's score method.|within 12 weeks after last dose of study drug|ITT population: all randomized/enrolled participants who received at least 1 dose of active DB study drugs in Substudy 1 (Substudy 1 ITT population, Arm A) or at least 1 dose of OL study drugs in Substudy 2 (Substudy 2 ITT population).||percentage of participants||95% Confidence Interval|Number
651710|NCT02023099|Secondary|Percentage of Participants in the Substudy 1 Arm A Active Treatment Group With On-treatment Virologic Failure During Treatment, by Subpopulation|On-treatment virologic failure among all randomized non-cirrhotic participants who received at least one dose of DB ABT-450/r/ABT-267 in the following subpopulations: noncirrhotic treatment-naïve (T-naïve) participants with a high baseline (BL) viral load (HCV RNA ≥ 100,000 IU/mL) who are eligible for IFN-based therapy (IFN-BT), a low viral load (HCV RNA < 100,000 IU/mL), or who are ineligible for IFN-BT; noncirrhotic treatment-experienced (T-exp) participants who relapsed after prior IFN-BT, who were nonresponders to prior IFN-BT, or who were intolerant to IFN-BT. On-treatment virologic failure is defined in Outcome measure 2. The 95% confidence interval was calculated using the Wilson's score method.|up to 12 weeks|ITT population: all randomized/enrolled participants who received at least 1 dose of active DB study drugs in Substudy 1 (Substudy 1 ITT population, Arm A).||percentage of participants||95% Confidence Interval|Number
651711|NCT02023099|Secondary|Percentage of Participants in the Active Treatment Group With On-treatment Virologic Failure During Treatment|"On-treatment virologic failure among all randomized non-cirrhotic participants who received at least one dose of DB ABT-450/r/ABT-267 and all enrolled participants with compensated cirrhosis who received at least one dose of OL ABT-450/r/ABT-267. On-treatment virologic failure is defined as the occurrence of at least one of the following:
confirmed HCV RNA ≥ LLOQ (defined as 2 consecutive HCV RNA measurements ≥ LLOQ) at any point during treatment after HCV RNA < LLOQ (rebound), or
confirmed increase from nadir in HCV RNA (defined as 2 consecutive HCV RNA measurements > 1 log10 IU/mL above nadir) at any time point during treatment (rebound), or
HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks (≥ 36 days) of treatment (failure to suppress).
The 95% confidence interval was calculated using the Wilson's score method."|up to 12 weeks|Intent-to-treat (ITT) population: randomized/enrolled participants who received at least 1 dose of DB study drugs in Substudy 1 (Substudy 1 ITT population) and completed treatment; n=number of participants in the given subpopulation (among noncirrhotic participants, a single participant could potentially be included in more than 1 subpopulation).||percentage of participants||95% Confidence Interval|Number
651712|NCT02023099|Primary|Percentage of Non-cirrhotic Treatment-Naïve Participants Who Are Eligible for Interferon (IFN)-Based Therapy and Who Have High Viral Load in the DB Active Treatment Group With a Sustained Virologic Response 12 Weeks Post-treatment|The percentage noncirrhotic treatment-naïve participants who were eligible for IFN-based therapy and who had high viral load at baseline (HCV RNA ≥ 100,000 IU/mL) in the DB active treatment group with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of active study drug (SVR12). Among noncirrhotic treatment-naïve participants who were eligible for IFN-based therapy and who had high viral load at baseline, superiority of Arm A to a clinically relevant threshold based on historical SVR rate with telaprevir plus pegylated interferon alpha/ribavirin (pegIFN/RBV) in treatment-naïve, non-cirrhotic patients with high viral load; the lower bound of 95% confidence interval (LCB) had to exceed 63% to achieve superiority. The 95% confidence interval was calculated using the normal approximation to the binomial distribution.|12 weeks after the last dose of study drug|Primary Efficacy Population: randomized non-cirrhotic treatment-naïve participants who are eligible for interferon-based therapy and who have high viral load and received at least one dose of double-blind ABT-450/r/ABT-267.||percentage of participants||95% Confidence Interval|Number
651713|NCT02022748|Secondary|Pharmacokinetic Parameter t1/2 of AR-C124910XX||3 days|The PK analysis set included all subjects who received at least 1 dose of study medication and for whom PK data are available with no major protocol deviations thought to significantly affect the pharmacokinetics of ticagrelor or its active metabolite AR-C124910XX.||hour||Standard Deviation|Mean
651714|NCT02022748|Secondary|Pharmacokinetic Parameter t1/2 of Ticagrelor||3 days|The PK analysis set included all subjects who received at least 1 dose of study medication and for whom PK data are available with no major protocol deviations thought to significantly affect the pharmacokinetics of ticagrelor or its active metabolite AR-C124910XX.||hour||Standard Deviation|Mean
651715|NCT02022748|Primary|Pharmacokinetic Parameter AUC0-∞ of AR-C124910XX||3 days|The PK analysis set included all subjects who received at least 1 dose of study medication and for whom PK data are available with no major protocol deviations thought to significantly affect the pharmacokinetics of ticagrelor or its active metabolite AR-C124910XX.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
651716|NCT02022748|Primary|Pharmacokinetic Parameter AUC0-∞ of Ticagrelor||3 days|The PK analysis set included all subjects who received at least 1 dose of study medication and for whom PK data are available with no major protocol deviations thought to significantly affect the pharmacokinetics of ticagrelor or its active metabolite AR-C124910XX.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
651717|NCT02022748|Primary|Pharmacokinetic Parameter Cmax of AR-C124910XX||3 days|The PK analysis set included all subjects who received at least 1 dose of study medication and for whom PK data are available with no major protocol deviations thought to significantly affect the pharmacokinetics of ticagrelor or its active metabolite AR-C124910XX.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
651718|NCT02022748|Primary|Pharmacokinetic Parameter Cmax of Ticagrelor||3 days|The PK analysis set included all subjects who received at least 1 dose of study medication and for whom PK data are available with no major protocol deviations thought to significantly affect the pharmacokinetics of ticagrelor or its active metabolite AR-C124910XX.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
651719|NCT02022670|Secondary|Baseline and Week 10 Aortic Pulse Wave Velocity||Baseline (Week 0), Week 10|||cm/sec||Standard Error|Mean
651724|NCT02022085|Secondary|Sound Processor Magnet Choice|To investigate how sound processor magnet choice will change over time. Six different magnetic strength could be chosen; SPM 1 had the lowest strength and SPM 6 the the highest.|4, 6, 12 weeks, 6 months|Intention-to-Treat (ITT) population; includes all patients who received surgical intervention at week 4. At week 6, 12 and month 6 one patient had left the study.||participants|||Number
651725|NCT02022085|Secondary|Magnetic Force|To investigate if the magnetic force required for sound processor magnet retention will change over time|4, 6, 12 weeks, 6 months|Intention-to-Treat (ITT) population; includes all patients who received surgical intervention.||Newton||Standard Deviation|Mean
651726|NCT02022085|Secondary|Implant Stability|Implant Stability Quotient - ISQ, a scale from 1 to 100, where 100 represent the highest stability|Visit 2 (surgery)|Intention-to-treat (ITT) population; includes all patients who received surgical intervention.||units on a scale||Standard Deviation|Mean
651727|NCT02022085|Secondary|Tissue Reduction Performed During Surgery|Surgical thinning of the soft tissue flap was advocated when the soft tissue thickness exceeded 6 mm|Visit 2 (surgery)|Intention-to-Treat (ITT) population; all patients who received surgical intervention.||participants|||Number
651728|NCT02022085|Secondary|Time to Perform Surgery|Time of first incision to time of last suture|Visit 2 (Surgery)|Intention-to-Treat (ITT) population; includes all patients who received the surgical intervention.||Minutes||Standard Deviation|Mean
651729|NCT02022085|Secondary|Speech, Spatial and Qualities of Hearing Scale (SSQ)|"Measuring change of speech, spatial and hearing experiences with the Baha Attract System from the pe-operative unaided situation. A scale from 0 to 10, where 0 represents can not hear at all, and 10 hear perfectly. The change from unaided to aided hearing is presented. A positive value indicates improved hearing, a negative value indicates impaired hearing."|Baseline before surgery, 6 months after surgery|Intention-to-Treat (ITT) population; includes all patient who received the surgical intervention.||units on scale||Standard Deviation|Mean
651730|NCT02022085|Secondary|Abbreviated Profile of Hearing Aid Benefit (APHAB)|Measuring change of Ease of communication, Reverberation, Background noise, Aversiveness and a Global score with the Baha Attract System from the pe-operative unaided situation. The absolute APHAB scale is between 0 and 100%, where 0% indicates no problems and 100% indicates always problem. The change from unaided to aided hearing is presented. A positive value indicates an improvement, a negative value an impairment.|Baseline before surgery, 6 months after surgery|Intention-to-Treat (ITT) population; includes all patients who received the surgical intervention.||units on scale||Standard Deviation|Mean
651731|NCT02022085|Secondary|Health Utility Index (HUI)|Change of health status and health related quality of life using the generic quality of life scale Health Utilities Index (HUI3) when wearing Baha Attract System compared to the pre-operative unaided situation. A health utility value of 1.00 indicates perfect health while a score of 0.00 indicates death. The change from unaided to aided hearing is presented. A positive value indicates an improved quality of life, a negative value indicates impaired quality of life.|Baseline before surgery, 6 months after surgery|Intention-to-Treat (ITT) population; includes all patients who received the surgical intervention.||units on a scale||Standard Deviation|Mean
651732|NCT02022085|Secondary|Speech in Quiet, Sound Processor on Softband Versus Baha Attract|The change of hearing performance with the Baha Attract System at 6 months compared to the pre-operative aided situation with the Sound Processor on a softband; Speech in quiet at 50, 65 and 80dB|Baseline before surgery, 6 months after surgery|Intention-to-Treat (ITT) population; includes all patients who received the surgical intervention.||Change of % correct words at the dB leve||Standard Deviation|Mean
651733|NCT02022085|Secondary|Adaptive Speech Recognition in Noise, Sound Processor on Softband Versus Baha Attract|The change of hearing performance with the Baha Attract System compared to the pre-operative aided situation with Sound Processor on a softband; Adaptive speech recognition in noise measured as signal to noise ratio|Baseline before surgery, 6 months after surgery|Intention-to-Treat (ITT) population; includes all patient who received the surgical intervention.||dB||Standard Deviation|Mean
651734|NCT02022085|Secondary|Hearing Performance; Threshold Audiometry Individual Frequencies, Sound Processor on Softband Versus Baha Attract|"The change of hearing performance with the Baha Attract System (aided) from the aided hearing performance with Sound processor on a softband before surgery; measured as free-field hearing tests:
Threshold audiometry at individual frequencies"|Baseline before surgery, 6 months after surgery|Intention-to-Treat population (ITT); includes all subjects who received the surgical intervention.||dB||Standard Deviation|Mean
651735|NCT02022085|Secondary|Hearing Performance; Threshold Audiometry PTA4, Sound Processor on Softband Versus Baha Attract|The change of hearing performance with the Baha Attract System (aided) from the aided hearing performance, sound processor on a softband, before surgery; measured as free-field hearing tests: Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz)|Baseline before surgery, 6 months after surgery|Intention-to-Treat (ITT) population; includes all subjects who received the surgical intervention.||dB||Standard Deviation|Mean
651736|NCT02022085|Secondary|Speech in Quiet, Unaided Versus Baha Attract|The change of hearing performance with the Baha Attract System at 6 months compared to the pre-operative unaided situation; Speech in quiet at 50, 65 and 80dB|Baseline before surgery, 6 months after surgery|Intention-to-Treat (ITT) population; includes all patients who received the surgical intervention.||Change of % correct words at the dB leve||Standard Deviation|Mean
651737|NCT02022085|Secondary|Adaptive Speech Recognition in Noise, Unaided Versus Baha Attract|The change of hearing performance with the Baha Attract System compared to the pre-operative unaided situation; Adaptive speech recognition in noise measured as signal to noise ratio|Baseline before surgery, 6 months after surgery|Intention-to-Treat (ITT) population; includes all patient who received the surgical intervention.||dB||Standard Deviation|Mean
651738|NCT02022085|Secondary|Hearing Performance; Threshold Audiometry Individual Frequencies, Unaided Versus Baha Attract|"The change of hearing performance with the Baha Attract System (aided) from the unaided hearing performance before surgery; measured as free-field hearing tests:
Threshold audiometry at individual frequencies"|Baseline before surgery, 6 months after surgery|Intention-to-Treat population (ITT); includes all subjects who received the surgical intervention.||dB||Standard Deviation|Mean
651739|NCT02022085|Primary|Hearing Performance; Threshold Audiometry PTA4, Unaided Versus Baha Attract|The change of hearing performance with the Baha Attract System (aided) from the unaided hearing performance before surgery; measured as free-field hearing tests: Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz)|Baseline before surgery, 24 months after surgery||||||
651740|NCT02022085|Primary|Hearing Performance; Threshold Audiometry PTA4, Unaided Versus Baha Attract|The change of hearing performance with the Baha Attract System (aided) from the unaided hearing performance before surgery; measured as free-field hearing tests: Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz)|Baseline before surgery, 12 months after surgery||||||
651741|NCT02022085|Primary|Hearing Performance; Threshold Audiometry PTA4, Unaided Versus Baha Attract|The change of hearing performance with the Baha Attract System (aided) at 6 months from the unaided hearing performance before surgery; measured as free-field hearing tests: Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz).|Baseline before surgery, 6 months after surgery|Intention-to-Treat (ITT) population; includes all subjects who received the surgical intervention.||dB||Standard Deviation|Mean
651742|NCT02022020|Primary|Percentage of Bleeding Types and Anatomic Locations of the Index Event at Time of ED/ER Presentation|Percentages of patients with index events by type (i.e. GI and/or GU) and anatomic location are presented. Multiple bleed locations are possible.|From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge (between 28OCT2010 (the date of the first data entry)) and 01AUG2013 (the date of data entry closure); Up to 1008 days.|Patients who received treatment at two countries (United States and Canada).||Percentage of participants|||Number
651743|NCT02022020|Primary|Percentage of Patients Receiving Different Types of Interventions to Stop Index Events Until Hospital Discharge|Percentages of patients receiving general intervention and general intervention combinations (i.e., medications, surgery, therapeutic procedures, transfusion/infusion, discontinuation of dabigatran) to manage the index events until their hospital discharge/release. Multiple interventions are possible.|From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge (between 28OCT2010 (the date of the first data entry)) and 01AUG2013 (the date of data entry closure); Up to 1008 days.|Patients who received treatment at two countries (United States and Canada).||Percentage of participants|||Number
651744|NCT02022020|Primary|Percentage of Patients With Index Event Safety Outcomes (Ongoing/Resolved/Deceased) at Time of Hospital Discharge|"Percentages of patients with index event safety outcomes (ongoing/resolved/deceased) at the time of their hospital discharge/release.
Emergency Department/Room (ED/ER).
Bleeding status at the time of discharge were classified by the principal investigator, using medical record information and medical opinion, as:
Ongoing, if symptoms of bleeding not completely resolved at time of discharge;
Deceased in case of death;
Resolved otherwise."|From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge (between 28October2010 (the date of the first data entry)) and 01August2013 (the date of data entry closure); Up to 1008 days.|Patients who received treatment at two countries (United States and Canada).||Percentage of participants|||Number
651745|NCT02022007|Other Pre-specified|Number of Participants With No Clinically Significant Changes in Liver Enzyme Levels or Positive Pregnancy Tests|The safety criteria will include laboratory values for liver enzymes and document the absence of pregnancy in all participants during the trial|16 weeks|||Participants|||Count of Participants
651746|NCT02022007|Secondary|Free Androgen Index (FAI)|Hyperandrogenism is measured by a combination of total testosterone (T) and sex hormone binding globulin (SHBG). The FAI was calculated as the quotient 100 x T/SHBG; hyperandrogenism was defined by a FAI value >3.85.|16 weeks|||index||Standard Deviation|Mean
651747|NCT02022007|Secondary|Triglyceride (TRG) /HDL-cholesterol Ratio|The measure of TRG levels and HDL- cholesterol levels are used as an estimate of insulin sensitivity. A TRG/HDL-C ratio of greater than 3.0 is used as an indirect measure of insulin resistance|16 weeks|||Ratio||Standard Deviation|Mean
651748|NCT02022007|Secondary|Menstrual Cycle Interval at 16 Weeks|The number of menstrual cycles during the previous year was recorded and the average menstrual interval calculated by dividing 365 by the number of menstrual cycles in the previous year . During the study period, the patients in a menstrual diary recorded vaginal bleeding over 16 weeks. The effects of treatment intervention on menstrual cycle interval was calculated evaluated by dividing 112 days by the number of menstrual cycles recorded in each patient’s menstrual cycle diary.|16 weeks|||days between menstrual cycles||Standard Deviation|Mean
651749|NCT02022007|Secondary|Waist Circumference at 16 Weeks|The circumference measurement was taken in the upright position using a 15-mm width flexible metric tape held close to the body but not tight enough to indent the skin. Waist circumference (WC) was measured in centimeters at the narrowest level midway between the lowest ribs and the iliac crest.|16 weeks|||centimeters||Standard Deviation|Mean
651750|NCT02022007|Secondary|Body Mass Index at 16 Weeks|Height and weight measurements were used to calculate body mass index (BMI), defined as kg/m2.|16 weeks|||kg/mg2||Standard Deviation|Mean
651751|NCT02022007|Secondary|Pancreatic ß-cell Compensatory Function|Post-treatment corrected early phase insulin secretion index (IGI/HOMA-IR). . Early pancreatic β-cell response is estimated as the insulinogenic index (IGI) derived from the ratio of the increment of insulin to that of glucose 30 minutes after a glucose load (insulin 30 min − insulin 0 min/glucose 30 min − glucose 0 min) corrected for by the relative level of insulin resistance (IGI/HOMA-IR which is estimated by homeostasis model assessment of insulin resistance using fasting insulin and glucose levels).|16 weeks|||Ratio||Standard Deviation|Mean
651752|NCT02022007|Secondary|Matsuda Index of Insulin-Sensitivity (SI OGTT)|Post-treatment insulin sensitivity index. The Matsuda index of whole-body insulin sensitivity is calculated from an oral glucose tolerance test (10,000/square root of [fasting glucose x fasting insulin] x [mean glucose x mean insulin during OGTT]), and is highly correlated with the rate of whole-body glucose disposal during the euglycemic insulin clamp|16 weeks|||Index||Standard Deviation|Mean
651753|NCT02022007|Secondary|Mean Blood Glucose During the OGTT|Post-treatment mean blood glucose levels. Mean blood glucose (MBG) concentrations were calculated by summing glucose values obtained at 0,30,60 and 120 minutes during the OGTT and dividing by 4.|16 weeks|||mmol/L||Standard Deviation|Mean
651754|NCT02022007|Secondary|Fasting Glucose|Post-treatment fasting glucose levels|16 weeks|||mmol/L||Standard Deviation|Mean
651772|NCT02020941|Secondary|Overall Response Rate (ORR) After 4 Courses of Treatment|Evaluate the overall response rate of patients receiving therapy. Patients are considered as having a response if their overall response is Partial Response or better. The percentage of patients achieving this and the exact 95% confidence interval will be calculated. Responses will be defined using the International Myeloma Working Group-Uniform Response Criteria (IMWG-URC).|At 16 weeks|All patients receiving at least one dose of study drug and having at least one evaluable post-baseline visit||percentage of participants||95% Confidence Interval|Number
651755|NCT02022007|Primary|Oral Disposition Index|Post-treatment in insulin-sensitivity-secretion index . The insulin secretion-sensitivity index (IS-SI) provides an estimate of β-cell compensation relative to the prevailing insulin resistance, not absolute insulin secretion. It is derived by applying the concept of the disposition index (DI) to measurements obtained during the 2-h OGTT. The IS-SI, a surrogate measure of the DI derived from the OGTT (IGI multiplied by the SIOGTT], was calculated as the product of acute β-cell response [IGI] and Matsuda index (SIOGTT) based on the existence of the predicted hyperbolic relationship between these two measures|16 weeks|||index||Standard Deviation|Mean
651756|NCT02022007|Primary|Glucose Metabolism|Glucose metabolic secretory status after drug treatment (normal, impaired or diabetic). We used the American Diabetes Association (ADA) definition of impairment which is fasting glucose greater than 100 mg/dL and/or 2 hour glucose greater than 140 mg/dL.|16 weeks|Change from impaired to normal was evaluated. No patients were diabetic at the start or completion of the study||Participants|||Count of Participants
651757|NCT02021812|Secondary|Number of Participants With 1 Month Device Related Endoleaks Assessed by an Independent Core Lab|Device-related endoelaks are defined as the presence of contrast within the aneurysm sac originating from the junction between any Branched TAG® Device component and the adjacent tissue (endoleak type IA or IB) OR the junction between the Aortic Component and either the SB Component or the Aortic Extender (type III endoleak).|1 month post procedure|1 participant was not assessed at 1 Month||Participants|||Count of Participants
651758|NCT02021812|Secondary|Number of Participants With 1 Month Side Branch Primary Patency Assessed by an Independent Core Lab||1 month post procedure|||Participants|||Count of Participants
651759|NCT02021812|Primary|Number of Participants With Primary Procedural Side Branch Patency as Assessed by Angiography|The presence of forward flow through the implanted Side Branch Component into the target branch vessel.|At conclusion of the treatment procedure (day 0)|||Participants|||Count of Participants
651760|NCT02021812|Primary|Number of Participants With Successful Study Device Deployment|Absence of deployment failure will be considered a successful deployment. Deployment failure will be considered the failure of any Branched TAG® Device component (Aortic Component, Aortic Extender, or SB Component) to be released from the delivery catheter resulting in a serious adverse event (SAE) due to mechanical failure or use error.|During treatment procedure (day 0)|||Participants|||Count of Participants
651761|NCT02021812|Primary|Number of Participants With Successful Study Device Access|Access to the aneurysm and target landing zone location is obtained via conventional vascular access and endovascular techniques.|During treatment procedure (day 0)|||Participants|||Count of Participants
651762|NCT02021461|Primary|Assessment of Taste Preference|Subject preference for 3 flavours of the ESL oral suspension was assessed based on a measured score using a 0-10 cm (minimum and maximum measured values) Visual Analogue Scale (VAS). Higher values represent the stronger preference.|single Study Day|||units on a scale (0-10 cm VAS)||Standard Deviation|Mean
651763|NCT02021331|Other Pre-specified|Bony Dimensional Changes|Measurements will be based off of standardized x-rays and CBCT.|Baseline, 6mo & 12mo after baseline|Data was not collected|||||
651764|NCT02021331|Secondary|Implant Survival|Checking to make sure the implant is stable.|2wk, 4wk, 6wk, 3mo, 6mo, 12mo|||Participants|||Count of Participants
651765|NCT02021331|Primary|Soft Tissue Diemensional Change|Tissue thickness will be measured from the digital impression and CBCT data from the hard tissue.|Baseline, 12mo after baseline|Data was not collected.|||||
651766|NCT02021071|Secondary|Fluoroscopy Time|Measure fluoroscopy time (minutes) needed during needle interventional procedure and compare the collected results with existing data from needle interventional procedures performed using XperGuide alone.|Patients will be followed starting from the procedure until hospital discharge or until 2 weeks after date of procedure at the latest|||Minutes||Full Range|Median
651767|NCT02021071|Primary|System Usability Scale (SUS) Score as a Measure of Qualitative Clinical Usefulness|"Evaluate the workflow, usability, and clinical impact of device by assessing clinical outcome and success of the procedures.
The SUS is a simple, ten-item attitude Likert scale giving a global view of subjective assessments of usability developed by Brooke, J. The user needs to provide agreement or disagreement for the 10 statements. After the appearing of the SUS in literature and once part of the ISO standard ISO 9241 Part 11 it has become an industry standard and has been used for over 25 years to measure usability.
The minimum score is 0 and the maximum core is 100. Analysis of 500 studies with SUS showed that the average SUS score is a 68. A SUS score above a 68 would be considered above average and anything below 68 is below average"|Patients will be followed starting from the procedure until hospital discharge or until 2 weeks after date of procedure at the latest|SUS Score is only assessed for new technology (arm/group: XperGuide with virtual path planning)||Scores on a scale||Standard Deviation|Mean
651768|NCT02020941|Secondary|Treatment Related Adverse Events Grade 3 or Higher|Number of unique patients who had a treatment related (possible, probable or definite) adverse events that were graded 3 or greater.|Up to 30 days after completion of study treatment, up to 2 years|All patients enrolled and received treatment.||participants|||Number
651769|NCT02020941|Secondary|Duration of Response (DOR)|Analysis will be performed using Kaplan-Meier estimates. Time from date of first confirmed response of partial response or better to date of progression or death. Only patients who had a response of partial response or better will be included in this analysis.|Time from first evidence of PR or better to disease progression or death, assessed up to 2 years|All patients who had a response of partial response or better||months||95% Confidence Interval|Median
651770|NCT02020941|Secondary|Time to Progression (TTP)|Analysis will be performed using Kaplan-Meier estimates. Time from date on treatment to date of progression. The observations of patients who died or remained alive and progression free were censored at date of death or last disease evaluation, respectively.|Time from first dose to disease progression, assessed up to 2 years|All patients enrolled and received treatment.||months||95% Confidence Interval|Median
651771|NCT02020941|Secondary|Progression-free Survival (PFS)|Analysis will be performed using Kaplan-Meier estimates. Time from date on treatment to date of progression for patients who progressed or date of death for patients who died without progressing. The observations of patients remaining alive and progression free were censored at date of last disease evaluation.|Time from first dose to first observed disease progression or death, assessed up to 2 years|All patients enrolled and received treatment.||months||95% Confidence Interval|Median
655261|NCT01953328|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
651773|NCT02020941|Primary|Overall Response Rate (ORR) After 8 Courses of Treatment|: Evaluate the overall response rate of patients receiving therapy. Patients are considered as having a response if their overall response is Partial Response or better. The percentage of patients achieving this and the exact 95% confidence interval will be calculated. Responses will be defined using the International Myeloma Working Group-Uniform Response Criteria (IMWG-URC).|At 32 weeks|All patients receiving at least one dose of study drug and having at least one evaluable post-baseline visit||percentage of participants||95% Confidence Interval|Number
651774|NCT02020863|Primary|Fluid Status During Surgery|The primary outcome between groups is preload independence, defined as % case time where Stroke Volume Variation (SVV) is ≤12%.|Duration of Surgery, up to 8 hours|Closed Loop Study population at Stroke Volume Variation (SVV) ≤12%||percentage of case time||Standard Deviation|Mean
651775|NCT02020577|Secondary|Recommended Phase II Dose Based on the Number of Patients With Dose Limiting Toxicity Events (Afatinib)|MTD was deemed the recommended Phase II dose based on the number of patients with dose limiting toxicity events at all treatment cycles.|All treatment cycle (each treatment cycle of 21 days)|Treated Set||mg|||Number
651776|NCT02020577|Secondary|Disease Control Rate|"For patients with measurable disease, disease control was defined as the proportion of patients having at least a best overall response of CR, PR or stable disease (SD).
As Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI:
Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression"|Post baseline tumour-imaging was performed at every 6 weeks (in the week preceding the start of Cycles 3, 5, 7, 9, 11, etc.) until EOT; up to 19 months|Treated set||Percentage of participants|||Number
651777|NCT02020577|Secondary|Objective Response|"Objective response was defined as the proportion of patients with measurable disease having at least a best overall response of complete response (CR) or partial response (PR), according to RECIST version 1.1.
As Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI:
Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression."|Post baseline tumour-imaging was performed at every 6 weeks (in the week preceding the start of Cycles 3, 5, 7, 9, 11, etc.) until EOT; up to 19 months|Treated set||Percentage of participants|||Number
651778|NCT02020577|Secondary|Best Overall Response|"Best overall response (according to RECIST version 1.1) was defined as the best response recorded at any time from the first administration of afatinib or cetuximab to the End of Treatment (EOT).
As Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI:
Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression."|Post baseline tumour-imaging was performed at every 6 weeks (in the week preceding the start of Cycles 3, 5, 7, 9, 11, etc.) until EOT; up to 19 months|Treated set||Percentage of participants|||Number
651779|NCT02020577|Secondary|Recommended Phase II Dose Based on the Number of Patients With Dose Limiting Toxicity Events (Cetuximab)|MTD was deemed the recommended Phase II dose based on the number of patients with dose limiting toxicity events at all treatment cycles.|All treatment cycle (each treatment cycle of 21 days)|Treated Set||mg/m2|||Number
651780|NCT02020577|Secondary|Dose Limiting Toxicities During All Treatment Cycles|Number of patients with DLT occuring during all treatment cycle is presented|All treatment cycle (each treatment cycle of 21 days)|Treated Set||Participants|||Number
651781|NCT02020577|Primary|MTD of Afatinib in Combination With Cetuximab Based on the Number of Patients With DLTs During the First Treatment Cycle (Cetuximab).|Maximum Tolerated Dose (MTD) of Afatinib in combination with cetuximab based on the number of patients with DLTs during the first treatment cycle (Dose escalation part).|First treatment cycle|Dose finding cohort treated set||mg/m2|||Number
651782|NCT02020577|Primary|Dose Limiting Toxicities During Cycle 1|"Number of Patients With Dose Limiting Toxicity (DLT) Occurring during Cycle 1. The following drug related AEs qualified as DLT:
1) CTCAE Grade ≥2 decrease in cardiac left ventricular function 2) CTCAE Grade 2 diarrhoea lasting for ≥7 days, despite appropriate use of standard antidiarrheal therapy based on Protocol Amendment 1 dated 22 Oct 2013 3) CTCAE Grade ≥3 diarrhoea despite appropriate use of standard anti-diarrheal therapy for at least 2 days. 4) CTCAE Grade ≥3 nausea and/or vomiting despite appropriate use of standard anti-emetics for at least 3 days 5) CTCAE Grade ≥3 rash despite standard medical management. 6) CTCAE Grade ≥3 fatigue lasting more than 7 days. 7) All other AEs of CTCAE Grade ≥3 (except alopecia and allergic reaction) that led to an interruption of afatinib and/or cetuximab dosing for more than 14 days until recovery to baseline or Grade 1, whichever was higher. 8) CTCAE Grade 4 hypomagnesemia or Grade 3 hypomagnesemia with clinically-significant sequelae"|First 21-day treatment cycle|Dose finding cohort treated set.||Participants|||Number
651783|NCT02020577|Primary|MTD of Afatinib in Combination With Cetuximab Based on the Number of Patients With DLTs During the First Treatment Cycle (Afatinib).|Maximum Tolerated Dose (MTD) of Afatinib in combination with cetuximab based on the number of patients with dose limiting toxicity (DLT) during the first treatment cycle (Dose escalation part). The MTD is defined as the highest dose level at which less than 33% of the patients experience DLT in first treatment cycle.|First 21 days treatment cycle|Dose finding cohort treated set: This patient set includes all patients enrolled in part A of the trial who were documented to have taken at least one dose of study medication.||mg|||Number
651784|NCT02020512|Primary|Change From Baseline in Intraocular Pressure (IOP) in the Study Eye|IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening).|Baseline, Week 5|Intent-to-Treat: all treated patients||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
651787|NCT02020369|Secondary|Time to Assessment of a “Good” or “Excellent” Response of Mild/Moderate Bleeding Episodes by the Patient|"Categories of Response to Treatment are Described as Follows:
None: No noticeable effect of the treatment on the bleed or worsening of patient’s condition. Continuation of treatment with the study drug was needed.
Moderate: Some effect of the treatment on the bleed was noticed, e.g., pain decreased or bleeding signs improved, but bleed continued and required continued treatment with the study drug. Good: Symptoms of bleed (e.g., swelling, tenderness, and decreased range of motion in the case of musculoskeletal haemorrhage) had largely been reduced by the treatment, but had not completely disappeared. Symptoms had improved enough to not require more infusions of the study drug.
Excellent: Full relief of pain and cessation of objective signs of bleed (e.g., swelling, tenderness, and decreased range of motion in the case of musculoskeletal haemorrhage). No additional infusion of study drug was required."|Within 24 hours of Bleeding Episode|Treated Population with non-missing measurements||Hours|Bleeding Episodes with event|95% Confidence Interval|Median
651788|NCT02020369|Secondary|Proportion of Mild/Moderate Bleeding Episodes With Patient (Pt)-Reported “Good” or “Excellent” Responses at 12 Hours|"Based on Patient-Reported Good or Excellent responses as per the below descriptions:
Good: Symptoms of bleed (e.g., swelling, tenderness, and decreased range of motion in the case of musculoskeletal haemorrhage) had largely been reduced by the treatment, but had not completely disappeared. Symptoms had improved enough to not require more infusions of the study drug.
Excellent: Full relief of pain and cessation of objective signs of bleed (e.g., swelling, tenderness, and decreased range of motion in the case of musculoskeletal haemorrhage). No additional infusion of study drug was required."|at 12 hours|Treated Population||Pt-reported proportion success of BEs|Bleeding Episodes (BEs)|95% Confidence Interval|Number
651789|NCT02020369|Primary|Proportion of Successfully Treated Mild/Moderate Bleeding Episodes|"For the primary efficacy endpoint, successful treatment of a bleeding episode was defined as a combination of the following:
“Good” or “Excellent” response noted by the patient
Study drug treatment: No further treatment with study drug beyond timepoint for this bleeding episode
No other hemostatic treatment needed for this bleeding episode
No administration of blood products that would indicate continuation of bleeding beyond timepoint
No increase of pain beyond timepoint that could not otherwise be explained"|12 hours after first administration of study drug|Treated Population||Proportion of Success of BEs|Bleeding Episodes (BEs)|95% Confidence Interval|Number
651790|NCT02020304|Secondary|Pruritus|patients reporting pruritis at 30 minutes after CSE injection, self reported and measured on a scale of 0 (no itching at all) up to 10 (itching as bad as can be imagined)|30 minutes|||units on a scale||Standard Deviation|Mean
651791|NCT02020304|Secondary|Analgesia Onset-15 Minutes Post Injection||up to 3 hours|number of subjects who achieved a VAS pain score of </= 3 at 15 minutes after injection||Participants|||Count of Participants
651792|NCT02020304|Secondary|Analgesia Onset-10 Minutes Post Injection||up to 3 hours|number of subjects who achieved a VAS pain score of </= 3 at 10 minutes after CSE injection||Participants|||Count of Participants
651793|NCT02020304|Secondary|Analgesia Onset-5 Minutes Post Injection||from time of CSE administration|number of subjects who achieved a VAS pain score of </=3 at 5 minutes after CSE injection||Participants|||Count of Participants
651794|NCT02020304|Primary|Time|length of time in minutes the combined spinal epidural dose duration is calculated from the time of administration until the request is made for additional analgesia (~1.5-3 hours) post dose. The subjects epidural is then dosed as per standard of care.|up to 3 hours|||minutes||Standard Deviation|Mean
651795|NCT02020135|Primary|Overall Radiologic Response|Overall radiologic response was measured at baseline and post-baseline. Imaging techniques used at screening were used throughout the study. The preferred imaging techniques include: bone scan, contrast enhanced CT of chest, contrast enhanced CT of pelvis, and contrast enhanced CT of upper & lower abdomen. Best overall radiologic response (confirmed), target and non-target lesions, was defined as responses in bone, visceral or nodal metastases according to the Modified Response Evaluation Criteria (RECIST 1.1). The best overall radiologic response is the best response recorded from the start of the treatment until disease progression/recurrence (taking, as reference for progressive disease, the smallest measurements recorded since the treatment started). The subject's best response assignment depended on the achievement of both measurement and confirmation criteria.|25 weeks|Both groups must also have received and progressed on abiraterone acetate and/or enzalutamide prior to the study (once these agents were commercially available for use). All subjects (n=9) enrolled in 2301EXT were evaluated.||% of subjects|||Number
651796|NCT02020135|Primary|CTC Response|Circulating tumor cells (CTC) response was measured at baseline and had at least one post-baseline assessment. Response was assessed as the maximum decrease over the extension study. Response was defined as any decrease from baseline of at least 50%.|25 weeks|Both groups must also have received and progressed on abiraterone acetate and/or enzalutamide prior to the study (once these agents were commercially available for use). The population examined was those subjects with a CTC baseline value and at least one post-baseline value.||% of responders|||Number
651797|NCT02020135|Primary|Percentage of Participants With Total Serum PSA Response|Total serum PSA (prostate-specific antigen) was measured at baseline and had at least one post-baseline assessment. PSA response was examined at two levels: at least 30% decrease or at least 50% decrease in serum PSA. Response was assessed as the maximum decrease over the extension study. Response was defined as any decrease from baseline of at least 30% or 50%.|25 Weeks|Both groups must also have received and progressed on abiraterone acetate and/or enzalutamide prior to the study (once these agents were commercially available for use). The population examined was those subjects with a PSA baseline value and at least one post-baseline value.||% of responders|||Number
651798|NCT02020031|Primary|Mean Concentration of Vancomycin in Bone Samples|During the procedure, bone samples (approximately 0.5 cm^3) were taken at regular intervals were taken at regular intervals until skin closure. All bone samples were taken from the femur, distant from the tibial intraosseous injection site. Vancomycin concentrations were determined by liquid chromatography coupled with tandem mass spectrometry. Times are given as minutes post surgical incision.|baseline to 24 hours|||µg/g||Standard Deviation|Mean
651799|NCT02020031|Primary|Mean Concentration of Vancomycin in Subcutaneous Fat|During the procedure, subcutaneous fat samples (approximately 0.5 cm^3) were taken at regular intervals until skin closure. Vancomycin concentrations were determined by liquid chromatography coupled with tandem mass spectrometry. Times are given as minutes post surgical incision.|Baseline to 24 hours|||µg/g||Standard Deviation|Mean
651800|NCT02019563|Secondary|MTA/FS Pulpotomy and RCT Treated Incisor Survival|Kaplan-Meier survival curves were generated for the MTA/FS pulpotomy and RCT treatment groups. One treated incisor was selected by random draw from each subject for survival analysis to preserve independence of observations. The log-rank test was used to statistically compare survival of incisors.|12 and 18 months|Four participants in the MTA/FS and two participants in the RCT group did not have data collected due to lost to follow-up. Remaining participants were censored if lost to follow-up, exfoliated, lost to trauma or had a non-occurrence of a failure before the trial end.||Proportion of participants|||Number
651801|NCT02019563|Secondary|Comparison of MTA/FS Pulpotomy Versus RCT Treated Incisors With Unacceptable Clinical Outcome at 18 Months Post-procedure.|Pulp treated incisors presenting with spontaneous pain, tenderness to percussion, fistula/sinus tract, soft tissue swelling and/or pathological tooth mobility were considered unacceptable clinical outcomes.|18 months after the procedure|||Proportion of incisors|Participants||Number
651802|NCT02019563|Secondary|Comparison of MTA/FS Pulpotomy Versus RCT Treated Incisors With Unacceptable Clinical Outcome at 12 Months Post-procedure.|Pulp treated incisors presenting with spontaneous pain, tenderness to percussion, fistula/sinus tract, soft tissue swelling and/or pathological tooth mobility were considered unacceptable clinical outcomes. Clinical outcomes between the MTA/FS pulpotomy and RCT groups were compared using Fisher’s Exact test.|12 months after the procedure|||Proportion of incisors|Participants||Number
651803|NCT02019563|Primary|Comparison of MTA/FS Pulpotomy Versus RCT Treated Incisors With Acceptable Radiographic Outcomes 18 Months Post-procedure.|Two disinterested pediatric dentists classified each treated incisor into one of three outcomes: N=incisor without pathologic change; Po=pathologic change present, follow-up recommended; and Px=pathologic change present, extract. Incisors rated N or Po were considered an acceptable radiographic outcome while incisors rated as Px were considered unacceptable.|18 months after the procedure|||Proportion of incisors|Participants||Number
651804|NCT02019563|Primary|Comparison of MTA/FS Pulpotomy Versus RCT Treated Incisors With Acceptable Radiographic Outcome at 12 Months Post-procedure.|Two disinterested pediatric dentists classified each treated incisor into one of three outcomes: N=incisor without pathologic change; Po=pathologic change present, follow-up recommended; and Px=pathologic change present, extract. Incisors rated N or Po were considered an acceptable radiographic outcome while incisors rated as Px were considered unacceptable.|12 months after the procedure|||Proportion of incisors|Participants||Number
651805|NCT02019550|Secondary|Change From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Scores to Week 8|The MusiQoL is a validated 31-item questionnaire describing 9 dimensions named according to its constitutive items:activities of daily living (8 items);psychological well-being (4 items);symptoms (3 items);friends relationships (4 items);family relationships (3 items);satisfaction with health care (RHCS 3 items);sentimental and sexual life (2 items);coping (2 items);and rejection (2 items). Each of the questions was answered using a 6-point Likert scale, defined as 1–Never/Not at all, 2–Rarely/A little, 3–Sometimes/Somewhat, 4–Often/A lot, 5–Always/Very much and 6–Not applicable. The scores of each dimension were obtained by computing mean of the item scores of dimension with negatively worded item scores reversed so that higher scores indicated higher health-related QoL. All 9 dimension scores were linearly transformed to a 0–100 scale,where higher score=higher health-related QoL. Global index score was computed as mean of the 9 dimension scores (range 0-100;higher score=higher QoL).|Baseline, up to Week 8|"FAS included all relapsing remitting multiple sclerosis subjects who received at least 1 injection of Rebif using either Rebif Rebidose or Rebiject II and had at least 1 post-baseline evaluation/assessment. Here Number of Participants Analyzed = subjects evaluable for this outcome, “Number Analyzed” = subjects evaluable for specified dimensions."||score on a scale||Standard Deviation|Mean
651806|NCT02019550|Secondary|Percentage of Subjects Rating Each Device on Ease of Use Based on User Trial Questionnaire (UTQ)|The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess their overall experience with using the device as “very difficult”, “difficult”, “neither easy nor difficult”, “easy”, or “very easy”. Percentage of subjects who rated the overall use of device as very difficult”, “difficult” or “neither easy nor difficult” were reported. Here results are presented by device sequence.|Weeks 4 and 8|"FAS included all relapsing remitting multiple sclerosis subjects who received at least 1 injection of Rebif using either Rebif Rebidose or Rebiject II and had at least 1 post-baseline evaluation/assessment. Here Number of Participants Analyzed signifies subjects evaluable for this outcome."||percentage of subjects|||Number
651807|NCT02019550|Secondary|Percentage of Subjects Rating Each Device on Overall Satisfaction With the Injection Device Based on User Trial Questionnaire (UTQ)|The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess their overall satisfaction with using the device. Subjects responded as “Strongly disagree”, “Disagree”, “Neither agree nor disagree”, “Agree”, “Strongly agree” that they were satisfied with the device. Here results are presented by device sequence.|Weeks 4 and 8|"FAS included all relapsing remitting multiple sclerosis subjects who received at least 1 injection of Rebif using either Rebif Rebidose or Rebiject II and had at least 1 post-baseline evaluation/assessment. Here Number of Participants Analyzed signifies subjects evaluable for this outcome."||percentage of subjects|||Number
651808|NCT02019550|Secondary|Percentage of Subjects Rating Each Device on Likelihood of Recommending the Device to Others Based on User Trial Questionnaire (UTQ)|The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked they would recommend injection device to others needing REBIF therapy. Subjects responded as “Very unlikely”, “Unlikely”, “Neutral/no opinion”, “Likely”, “Very likely”. Here results are presented by device sequence.|Weeks 4 and 8|"FAS included all relapsing remitting multiple sclerosis subjects who received at least 1 injection of Rebif using either Rebif Rebidose or Rebiject II and had at least 1 post-baseline evaluation/assessment. Here Number of Participants Analyzed signifies subjects evaluable for this outcome."||percentage of subjects|||Number
651848|NCT02016963|Primary|Number of Participants Who Developed a Positive Anti-raxibacumab Antibody Response|Number of participants who developed an positive anti-raxibacumab antibody response during the study were assessed.The antibody response to raxibacumab was assessed using a screening assay (i.e. by electrochemiluminescence counts). Positive samples would be further tested in an inhibition of binding assay to confirm the specificity of binding.|From the date of the dose administration of study agent for this study (Day 0) until Day 70|As-treated population : all participants who received 1 dose of study treatment.||Participants|||Number
651809|NCT02019550|Secondary|Percentage of Subjects Rating Each Device on Level of Satisfaction With Information Provided by the Trainer Based on User Trial Questionnaire (UTQ)|The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess whether the trainer provided easily understandable, unbiased and practical information about proper injection. Subjects responded as “Strongly disagree”, “Disagree”, “Neither agree nor disagree”, “Agree”, “Strongly agree”. Here results are presented by device sequence.|Weeks 4 and 8|"FAS included all relapsing remitting multiple sclerosis subjects who received at least 1 injection of Rebif using either Rebif Rebidose or Rebiject II and had at least 1 post-baseline evaluation/assessment. Here Number of Participants Analyzed signifies subjects evaluable for this outcome."||percentage of subjects|||Number
651810|NCT02019550|Secondary|Percentage of Subjects Rating Each Device on Amount of Needle Anxiety While Using the Device Based on User Trial Questionnaire (UTQ)|The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess their level of anxiety while giving themselves an injection with device. Subjects assessed their anxiety as “Not at all anxious”, “A little anxious”, “Moderately anxious”, “Very anxious”, “Extremely anxious”. Here results are presented by device sequence.|Weeks 4 and 8|"FAS included all relapsing remitting multiple sclerosis subjects who received at least 1 injection of Rebif using either Rebif Rebidose or Rebiject II and had at least 1 post-baseline evaluation/assessment. Here Number of Participants Analyzed signifies subjects evaluable for this outcome."||percentage of subjects|||Number
651811|NCT02019550|Secondary|Percentage of Subjects Rating Each Device on Minimization of Safety Hazards Based on User Trial Questionnaire (UTQ)|The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess whether the device features help minimize safety hazards. Subjects responded as “Strongly disagree”, “Disagree”, “Neither agree nor disagree”, “Agree”, “Strongly agree”. Here results are presented by device sequence.|Weeks 4 and 8|"FAS included all relapsing remitting multiple sclerosis subjects who received at least 1 injection of Rebif using either Rebif Rebidose or Rebiject II and had at least 1 post-baseline evaluation/assessment. Here Number of Participants Analyzed signifies subjects evaluable for this outcome."||percentage of subjects|||Number
651812|NCT02019550|Secondary|Percentage of Subjects Rating Each Device on Level of Convenience of Storing the Device Based on User Trial Questionnaire (UTQ)|The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess how convenient it was to store the injection device. Subjects responded as “Strongly disagree”, “Disagree”, “Neither agree nor disagree”, “Agree”, “Strongly agree” that the device was convenient to store.|Weeks 4 and 8|"FAS included all relapsing remitting multiple sclerosis subjects who received at least 1 injection of Rebif using either Rebif Rebidose or Rebiject II and had at least 1 post-baseline evaluation/assessment. Here Number of Participants Analyzed signifies subjects evaluable for this outcome. Here results are presented by device sequence."||percentage of subjects|||Number
651813|NCT02019550|Secondary|Percentage of Subjects Rating Each Device on Level of Convenience of Using the Device Based on User Trial Questionnaire (UTQ)|The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess their level of convenience of using the device as “Extremely inconvenient”, “Somewhat inconvenient”, “Neutral/no opinion”, “Somewhat convenient”, or “Extremely convenient”. Here results are presented by device sequence.|Weeks 4 and 8|"FAS included all relapsing remitting multiple sclerosis subjects who received at least 1 injection of Rebif using either Rebif Rebidose or Rebiject II and had at least 1 post-baseline evaluation/assessment. Here Number of Participants Analyzed signifies subjects evaluable for this outcome."||percentage of subjects|||Number
651814|NCT02019550|Secondary|Number of Subjects Rating Each Device on Level of Satisfaction With Using the Device Away From Home Based on User Trial Questionnaire (UTQ)|The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess their level of satisfaction with using the device while away from home. Subjects assessed if they were satisfied with their ability to use the device while away from home as “Strongly disagree”, “Disagree”, “Neither agree nor disagree”, “Agree”, “Strongly agree”. Here results are presented by device sequence.|Weeks 4 and 8|"FAS included all relapsing remitting multiple sclerosis subjects who received at least 1 injection of Rebif using either Rebif Rebidose or Rebiject II and had at least 1 post-baseline evaluation/assessment. Here Number of Participants Analyzed = subjects evaluable for this outcome, Number Analyzed=subjects evaluable at the specified time point."||subjects|||Number
651815|NCT02019550|Secondary|Percentage of Subjects Rating Each Device on Ease of Holding Based on User Trial Questionnaire (UTQ)|The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess their overall experience with holding the device as “very difficult”, “difficult”, “neither easy nor difficult”, “easy”, or “very easy”. Here results are presented by device sequence.|Weeks 4 and 8|"FAS included all relapsing remitting multiple sclerosis subjects who received at least 1 injection of Rebif using either Rebif Rebidose or Rebiject II and had at least 1 post-baseline evaluation/assessment. Here Number of Participants Analyzed signifies subjects evaluable for this outcome."||percentage of subjects|||Number
651816|NCT02019550|Secondary|Percentage of Subjects Rating Each Device on Number of Steps Involved in Completing the Injection Based on User Trial Questionnaire (UTQ)|The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess their level of satisfaction with respect to number of steps it took to complete an injection with the device. Subjects assessed if they were satisfied as “Strongly disagree”, “Disagree”, “Neither agree nor disagree”, “Agree”, “Strongly agree”. Here results are presented by device sequence.|Weeks 4 and 8|"FAS included all relapsing remitting multiple sclerosis subjects who received at least 1 injection of Rebif using either Rebif Rebidose or Rebiject II and had at least 1 post-baseline evaluation/assessment. Here Number of Participants Analyzed signifies subjects evaluable for this outcome."||percentage of subjects|||Number
651849|NCT02016690|Secondary|Mean Duration of Respiratory Support|The presence/absence of respiratory support (oxygen therapy, mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure, and other mechanical respiratory support or Intensive Care Unit admission) and the start and end dates of respiratory support were documented on the case report form (CRF).|From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks|Participants with available data||days||Standard Deviation|Mean
651817|NCT02019550|Secondary|Percentage of Subjects Rating Each Device on Amount of Time Needed to Complete the Injection Based on User Trial Questionnaire (UTQ)|The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess their level of satisfaction with respect to the amount of time it took to complete injection with the device. Subjects assessed if they were satisfied as “Strongly disagree”, “Disagree”, “Neither agree nor disagree”, “Agree”, “Strongly agree”. Here results are presented by device sequence.|Weeks 4 and 8|"FAS included all relapsing remitting multiple sclerosis subjects who received at least 1 injection of Rebif using either Rebif Rebidose or Rebiject II and had at least 1 post-baseline evaluation/assessment. Here Number of Participants Analyzed signifies subjects evaluable for this outcome."||percentage of subjects|||Number
651818|NCT02019550|Secondary|Number of Subjects Rating Each Device on Level of Satisfaction With Using the Device While Traveling Based on User Trial Questionnaire (UTQ)|The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess their level of satisfaction with using the device while traveling (defined as being away from home overnight). Subjects assessed if they were satisfied with their ability to use the device while traveling overnight as “Strongly disagree”, “Disagree”, “Neither agree nor disagree”, “Agree”, “Strongly agree”. Here results are presented by device sequence.|Weeks 4 and 8|FAS included all relapsing remitting multiple sclerosis subjects who received at least 1 injection of Rebif using either Rebif Rebidose or Rebiject II and had at least 1 post-baseline evaluation/assessment. Here “Number of Participants Analyzed” = subjects evaluable for this outcome, “Number Analyzed”=subjects evaluable at the specified time point.||subjects|||Number
651819|NCT02019550|Primary|Percentage of Subjects Rating Each Device as “Easy/Very Easy to Use” Based on User Trial Questionnaire (UTQ) up to Week 8|The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess their overall experience with using the device as “very difficult”, “difficult”, “neither easy nor difficult”, “easy”, or “very easy”. Percentage of subjects who rated the overall use of device as “easy” or “very easy” were reported. Here results are presented by device used.|Baseline up to Week 8|FAS included all relapsing remitting multiple sclerosis subjects who received at least 1 injection of Rebif using either Rebif Rebidose or Rebiject II and had at least 1 post-baseline evaluation/assessment. Here “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome.||percentage of subjects|||Number
651820|NCT02019550|Primary|Percentage of Subjects Rating Each Device as “Easy/Very Easy to Use” Based on User Trial Questionnaire (UTQ) at Week 8|The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess their overall experience with using the device as “very difficult”, “difficult”, “neither easy nor difficult”, “easy”, or “very easy”. Percentage of subjects who rated the overall use of device as “easy” or “very easy” were reported. Here results are presented by device sequence.|Week 8|FAS included all relapsing remitting multiple sclerosis subjects who received at least 1 injection of Rebif using either Rebif Rebidose or Rebiject II and had at least 1 post-baseline evaluation/assessment. Here “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome.||percentage of subjects|||Number
651821|NCT02019550|Primary|Percentage of Subjects Rating Each Device as “Easy/Very Easy to Use” Based on User Trial Questionnaire (UTQ) at Week 4|The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess their overall experience with using the device as “very difficult”, “difficult”, “neither easy nor difficult”, “easy”, or “very easy”. Percentage of subjects who rated the overall use of device as “easy” or “very easy” were reported. Here results are presented by device sequence.|Week 4|FAS included all relapsing remitting multiple sclerosis subjects who received at least 1 injection of Rebif using either Rebif Rebidose or Rebiject II and had at least 1 post-baseline evaluation/assessment. Here “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome.||percentage of subjects|||Number
651850|NCT02016690|Secondary|Number of Hospitalized Participants Requiring Respiratory Support|The presence/absence of respiratory support, (oxygen therapy, mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure, and other mechanical respiratory support or Intensive Care Unit admission) the start and end dates of respiratory support, and the dates of hospitalization and discharge were documented on the case report form (CRF).|From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks|Participants with available data||Participants|||Count of Participants
652459|NCT02007278|Secondary|Percentage of Patients Who Achieved a Decrease Equal to or Greater Than 0.3% in Value of HbA1c at Week 12||Screening visit , 12 weeks of treatment|Analysis set includes all randomized patients excluding the ones who were prematurely withdrawn and the ones who have confirmed non-concordant data||percentage of patients|||Number
651826|NCT02018809|Secondary|Morisky Medication Adherence Scale (MMAS)|"The secondary outcome will be subjects' self-reports medication adherence. Morisky et al. developed this 8-item MMAS (MMAS-8) in 2008. The first seven items are Yes/No responses while the last item is a 5-point Likert response. The scoring scheme is: “Yes” = 0 and “No” = 1 (and 0 = 0 and 1-4 = 1 for Likert question). The items are summed to give a range of scores from 0 to 8. Respondents' summed score get grouped as follows: 0 = High Adherence; 1-2 = Medium Adherence; 3-8 = Low Adherence."|90 days|||units on a scale||Inter-Quartile Range|Median
651827|NCT02018809|Primary|Statin Adherence|The primary outcome will be the percent of statin doses taken during the study as measured by the GlowCaps.|90 days|||percentage of correct statin doses||Standard Deviation|Mean
651828|NCT02017574|Secondary|EEG Derived High Alpha Power|Brain electrophysiology measure of attentional processes as indexed by high alpha power (10-13 Hz). The unit of measurement is a percentage as the amount of power (microvolts squared) in the high alpha band was divided by the total power in the spectrum (i.e. 1-50 Hz). This method is commonly employed to normalize the power of a particular frequency if the statistical design includes a between subjects factor.|2 Years|Of the 24 participants recruited , 4 were excluded from the analysis due to poor data quality.||percentage of the total power||Standard Error|Mean
651829|NCT02017574|Primary|Quality of Motor Performance|Quality of motor behavior was indexed by the percentage of samples in which the participants were within the trained (i.e. optimal) trajectory. The trained trajectory was a 2cm wide channel in the shape of a half circle between two targets which were 25cm apart from each other. Therefore, the scale measure is a percentage which can range between 0 and 100%.|2 Years|Of the 24 participants recruited , 4 were excluded from the analysis due to poor data quality.||percentage of samples not 'on' task||Standard Deviation|Mean
651830|NCT02017093|Primary|Fugl-Meyer Assessment Score|The Fugl-Meyer assessment score (FM) is a zero (disabaled function) to 66 points (high level of function) scale that evaluates the level of the motor impairment of the upper extremity, in stroke patients.|The measured assessed at the begining of the rehabilitation (T1) and about 5 weeks later at the end of the rehabilitation (T2).|||units on a scale||Standard Deviation|Mean
651831|NCT02017093|Primary|Improvement in Average Movement Trajectory Error From T1 to T2|While reaching, people have typical movement pattern of trajectory, moving the end-effector (hand) in straight line. The abnormal motor control after a stroke may cause these patients to deviate from this pattern. Our robotic device enabled us to measure the magnitude of the deviation from the optimal profile of healthy people. This was followed by a calculation of the average error the paricipants made in each treatment session. So we finally recieved a score of the average magnitude of trajectory error the participants made through a treatment session. Each treatment seesoin composed of about 100 reaching movements. The outcome measure expresses the change in the movement error from T1 to T2.|The outcome was assessed at the begining of the rehabilitation (T1) and about 5 weeks later at the end of rehabilitation (T2).|||cm||Standard Deviation|Mean
651832|NCT02017015|Secondary|Kaplan-Meier Estimate of Overall Survival (OS)|Overall survival was defined as the time from the date of first treatment to the date of death. Participants who did not die at the end of study or clinical data cut were censored on the last-known-to-be-alive date or the clinical cut-off date, whichever was earlier.|From the first participant enrolled to data cut off of 01 June 2015; up to approximately 70 weeks|ITT population includes all enrolled participants||months||95% Confidence Interval|Median
651833|NCT02017015|Secondary|Duration of Response (DoR) Based on IRR According to RECIST Guidelines|DoR was defined as the time from the first tumor assessment when the confirmed CR/PR response criterion is met to the date of disease progression based on IRR following RECIST 1.0. Only for those participants with a confirmed CR/PR. If a participant had disease progression, then the date of disease progression was the event date. For a participant who did not develop disease progression or disease progression occurred after 2 or more missing tumor assessments, the participant was censored on the date of last tumor assessment where the participant was documented to be progression free. If a participant died prior to disease progression, the participant was censored on the date of death. If patient started new anti-cancer therapy, the patient was censored on the last tumor assessment date on or prior to the start date of new anti-cancer therapy|Assessment performed every 8 weeks; from the first participant enrolled to cut off date of 01 June 2015; up to approximately 70 weeks|Includes participants with a Confirmed Complete or Partial Response||months||95% Confidence Interval|Median
651916|NCT02016105|Secondary|DLQI|Proportion of patients reporting a DLQI of 0 or 1 (no effect at all on patient's life)|At Week 17 only|The Per-protocol analysis set (PPS) consists of patients who completed the study up to Week 16 and had no major protocol deviations or additional exclusion criteria up to and including Week 16.||% of patients with DLQI of 0 or 1|||Number
651834|NCT02017015|Primary|Overall Response Rate (ORR) Based on Independent Radiological Review (IRR)|ORR was defined as the percentage of participants who achieve a complete response (CR) or partial response (PR) based on independent radiological review per Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (V1.0). Using RECIST Version 1.0, participants were to achieve either a complete response defined as the disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation or partial response defined as at least a 30% decrease in the sum of the longest diameters of target lesions and no progression in non-target lesions based on confirmed responses from the independent radiological review of best overall response during study treatment.|Assessment every 8 weeks; Day 1 to data cut off of 01 June 2015; Up to approximately 70 weeks|Intent to Treat (ITT) population included all participants enrolled into the study||percentage of participants||95% Confidence Interval|Number
651835|NCT02017015|Secondary|Number of Participants Experiencing Treatment Emergent Adverse Events (TEAE)|TEAEs were defined as adverse events (AEs) that began or worsened in severity on or after the date of the first dose of study drug and within 30 days of the last dose of study drug. A Serious AE (SAE) = any AE that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability, is a congenital anomaly/birth defect; constitutes an important medical event. Treatment-related AEs (TRAEs) were any TEAEs considered to be related to the study drug. A TRAE is a TEAE with relationship as suspected to either ABI-007 or gemcitabine The intensity of AEs were graded 1 to 5 according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. Other AEs not described in the CTCAE criteria, the intensity will be assessed by the investigator as mild grade (Gr 1), moderate (grade 2), severe (grade 3), life-threatening (grade 4) or death (grade 5)|Study drug initiation through 30 days after the last dose of study drug or End Of Study, whichever is later; maximum treatment duration was 54.9 weeks|Safety population includes all enrolled participants who received at least 1 dose of study drug||participants|||Number
651836|NCT02016963|Secondary|Mean Raxibacumab Concentration-time Following an IV Infusion Raxibacumab Dose|Blood was collected from each participant at the selected times: pre-dose (Day 0), 0.00347 hours (Day 0), 0.3333 hours (Day 0), Day 1, Day 3, Day 7, Day 14, Day 21, Day 28, Day 42, and Day 56 post-dose. Serum specimens were analyzed for raxibacumab using a validated electrochemiluminescense-based assay. The individual serum raxibacumab concentration data were summarized by nominal collection time and treatment group using descriptive statistics|From the date of the dose administration of study agent for this study (Day 0) until Day 56|As-treated population||Micrograms/milliliter (µg/mL)||Standard Deviation|Mean
651837|NCT02016963|Secondary|Number of Participants With at Least a 2-grade Worsening From Baseline in Urinalysis Toxicities|Urinalysis parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.Baseline is defined as the value of the variable measured at Day 0 prior to dosing.|From the date of the dose administration of study agent for this study (Day 0) until Day 70|As-treated population||Participants|||Number
651838|NCT02016963|Secondary|Number of Participants With Urinalysis Toxicities of the Indicated Grade|Urinaysis parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.|From the date of the dose administration of study agent for this study (Day 0) until Day 70|As-treated population||Participants|||Number
651839|NCT02016963|Secondary|Number of Participants With at Least a 2-grade Worsening From Baseline in Other Chemistry Toxicities|The number of participants with at least a 2-grade worsening from Baseline in other chemistry toxicities is presented. Other clinical chemistry parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.Baseline is defined as the value of the variable measured at Day 0 prior to dosing.|From the date of the dose administration of study agent for this study (Day 0) until Day 70|As-treated population||Participants|||Number
651840|NCT02016963|Secondary|Number of Participants With Other Chemistry Toxicities of the Indicated Grade|Other chemistry parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.|From the date of the dose administration of study agent for this study (Day 0) until Day 70|As-treated population||Participants|||Number
651851|NCT02016690|Secondary|Mean Hospitalization Length Due to Respiratory Syncytial Virus (RSV) Infection|The date of hospitalization due to RSV infection and the date of hospital discharge were documented on the case report form (CRF).|From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks|Participants with available data||days||Standard Deviation|Mean
651841|NCT02016963|Secondary|Number of Participants With at Least a 2-grade Worsening From Baseline in Electrolyte Toxicities|The number of participants with at least a 2-grade worsening from Baseline in electrolyte toxicities is presented. Electrolyte function parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0.Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable. Baseline is defined as the value of the variable measured at Day 0 prior to dosing.|From the date of the dose administration of study agent for this study (Day 0) until Day 70|As-treated population||Participants|||Number
651842|NCT02016963|Secondary|Number of Participants With Electrolyte Toxicities of the Indicated Grade|Electrolyte function parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.|From the date of the dose administration of study agent for this study (Day 0) until Day 70|As-treated population||Participants|||Number
651843|NCT02016963|Secondary|Number of Participants With at Least a 2-grade Worsening From Baseline in Liver Toxicities|The number of participants with at least a 2-grade worsening from Baseline in liver toxicities is presented. Liver function parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable. Baseline is defined as the value of the variable measured at Day 0 prior to dosing.|From the date of the dose administration of study agent for this study (Day 0) until Day 70|As-treated population||Participants|||Number
651844|NCT02016963|Secondary|Number of Participants With Liver Toxicities of the Indicated Grade|Liver function parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.|From the date of the dose administration of study agent for this study (Day 0) until Day 70|As-treated population||Participants|||Number
651845|NCT02016963|Secondary|Number of Participants With at Least a 2-grade Worsening From Baseline in Hematological Toxicities|The number of participants with at least a 2-grade worsening from Baseline in hematological toxicities is presented. Clinical hematological parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable. Baseline is defined as the value of the variable measured at Day 0 prior to dosing.|From the date of the dose administration of study agent for this study (Day 0) until Day 70|As-treated population||Participants|||Number
651846|NCT02016963|Secondary|Number of Participants With Hematological Toxicities of the Indicated Grade|Clinical hematological parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.|From the date of the dose administration of study agent for this study (Day 0) until Day 70|As-treated population||Participants|||Number
651847|NCT02016963|Secondary|Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. This includes worsening (eg, increase in frequency or severity) of pre-existing conditions. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in deciding whether reporting is appropriate in other situations. Refer to the General Adverse AE/SAE module for a complete list of AEs and SAEs.|From the date of the dose administration of study agent for this study (Day 0) until Day 70|As-treated population||Participants|||Number
651917|NCT02016105|Secondary|IGA Response Rate|Proportion of patients achieving a score of 0 (“clear”) or 1 (“almost clear”) or improved by at least 2 points of the IGA scale compared to baseline at Week 51|At Week 51 only|||percent of participants|||Number
651852|NCT02016690|Secondary|Number of Participants Hospitalized Due to Respiratory Syncytial Virus (RSV) Infection|Hospitalization due to RSV infection or the presence/absence of positive RSV antigen test results during hospitalization was documented on the case report form (CRF).|From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks|Participants with available data||Participants|||Count of Participants
651853|NCT02016690|Secondary|Change in Lower Respiratory Tract Infection (LRI) Score During the Study|The Lower Respiratory Tract Infection (LRI) Score ranged from 0 (well or baseline); 1 (Upper Respiratory tract Infection [URI]), mild); 2 (LRI); 3 (LRI, moderate); 4 (LRI, severe) to 5 (Respiratory Failure). Components of the score included respiratory rate per minute, oxygen saturation, and physical findings of LRI. LRI scores were documented on the case report form (CRF).|From the first administration of palivizumab up to the last administration of palivizumab, up to 36 weeks|Participants with available data||units on a scale||Standard Deviation|Mean
651854|NCT02016690|Primary|Number of Participants With Adverse Drug Reactions|"An adverse event (AE) was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with their treatment. If a causal relationship with palivizumab was: Related, Causality cannot be ruled out, or Not assessable as determined by the investigator, it was classified as an adverse drug reaction (ADR). An AE was considered a serious adverse event (SAE) and a serious adverse drug reaction (SADR) if the severity of the AE or ADR was any one of the following, as determined by the investigator: Death, Life-threatening condition, Hospitalization or prolonged hospitalization, Persistent or significant disability, or Other medically important condition. Information about AEs and ADRs was documented on the case report form (CRF)."|From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks|Participants enrolled via consecutive enrollment method who had a completed CRF. Participants were excluded if there was enrollment at a non-contracting institution or beyond the contracted number; duplicate enrollment; no palivizumab administration; or if palivizumab administration began outside of the investigation period.||Participants|||Count of Participants
651855|NCT02016690|Primary|Number of Participants With Serious Adverse Events|A serious adverse event was defined as any untoward medical occurrence in a participant that the investigator believed to be causally related to the study treatment and met at least one of the following criteria: death, life-threatening, hospitalization or prolongation of hospitalization, persistent or significant disability/incapacity, or important medical event requiring medical or surgical intervention to prevent serious outcome. Serious adverse events were documented on the case report form (CRF).|From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks|Participants enrolled via consecutive enrollment method who had a completed CRF. Participants were excluded if there was enrollment at a non-contracting institution or beyond the contracted number; duplicate enrollment; no palivizumab administration; or if palivizumab administration began outside of the investigation period.||Participants|||Count of Participants
651856|NCT02016690|Primary|Number of Participants With Adverse Events|An adverse event (AE) was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with their treatment. Adverse events were documented on the case report form (CRF).|From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks|Participants enrolled via consecutive enrollment method who had a completed CRF. Participants were excluded if there was enrollment at a non-contracting institution or beyond the contracted number; duplicate enrollment; no palivizumab administration; or if palivizumab administration began outside of the investigation period.||Participants|||Count of Participants
651857|NCT02016625|Primary|AUC τ,ss (Area Under the Concentration-time Curve of the FDV [Followed by Tac Treatment] in Plasma at Steady State Over a Uniform Dosing Interval τ)|"AUC τ,ss (area under the concentration-time curve of the FDV [followed by tac treatment] in plasma at steady state over a uniform dosing interval τ).
PK sampling (relative to the first cyclo administration [h:min]):
period 2 For FDV
-144:00h, -120:00h, -96:00h, -72:00h, -48:00h, -24:00h, -23:30h, -23:00h, -22:30h, -22:00h, -21:00h, -20:00h, -18:00h, -16:00h, -14:00h, -12:00h, -8:00h, 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h."|up to 168 hours (details in description)|PKS tac||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
651858|NCT02016625|Primary|C24,ss (Maximum Measured Concentration of the FDV [Followed by Tac Treatment] in Plasma at Steady State Over a 24 Hour Dosing Interval)|"PK sampling (relative to the first tac administration [h:min]):
period 2 For FDV
-144:00h, -120:00h, -96:00h, -72:00h, -48:00h, -24:00h, -23:30h, -23:00h, -22:30h, -22:00h, -21:00h, -20:00h, -18:00h, -16:00h, -14:00h, -12:00h, -8:00h, 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h."|up to 168 hours (details in description)|PKS tac||ng/mL||Geometric Coefficient of Variation|Geometric Mean
651859|NCT02016625|Primary|Cmax,ss (Maximum Measured Concentration of the FDV [Followed by Tac Treatment] in Plasma at Steady State Over a Uniform Dosing Interval τ)|"Cmax,ss (maximum measured concentration of the FDV [followed by tac treatment] in plasma at steady state over a uniform dosing interval τ).
PK sampling (relative to the first tac administration [h:min]):
period 2 For FDV
-144:00h, -120:00h, -96:00h, -72:00h, -48:00h, -24:00h, -23:30h, -23:00h, -22:30h, -22:00h, -21:00h, -20:00h, -18:00h, -16:00h, -14:00h, -12:00h, -8:00h, 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h."|up to 168 hours (details in description)|PKS tac||ng/mL||Geometric Coefficient of Variation|Geometric Mean
651860|NCT02016625|Primary|Cmax (Maximum Measured Concentration of the Tac in Plasma)|"Cmax (maximum measured concentration of the tac in plasma).
PK sampling (relative to the first tac administration [h:min]):
Period 1:
for tac 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 144:00h, 168:00h, 192:00h Period 2 For tac
-192:00h, -168:00h, 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h"|up to 192 hours (details in description)|PKS tac||ng/mL||Geometric Coefficient of Variation|Geometric Mean
651870|NCT02016482|Secondary|Percentage of Participants With a New Diagnosis of Psoriatic Arthritis (PsA) During the Study|The percentage of participants with a new diagnosis of PsA (ie, with an adverse event of PsA) during the study, among participants without PsA at Baseline.|up to Week 26|ITT Population in Period A: all participants who were randomized at Baseline and did not have PsA at Baseline. Observed cases.||percentage of participants|||Number
651861|NCT02016625|Primary|AUC 0-tz (Area Under the Concentration-time Curve of the Tac in Plasma Over the Time Interval From 0 to the Last Quantifiable Point)|"AUC 0-tz (area under the concentration-time curve of the tac in plasma over the time interval from 0 to the last quantifiable point).
PK sampling (relative to the first tac administration [h:min]):
Period 1: for tac
0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 144:00h, 168:00h, 192:00h
Period 2 For tac
-192:00h, -168:00h, 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h"|up to 192 hours (details in description)|PKS tac||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
651862|NCT02016625|Primary|AUC 0-infinity (Area Under the Concentration-time Curve of the Tac in Plasma Over the Time Interval From 0 Extrapolated to Infinity)|"AUC 0-infinity (area under the concentration-time curve of the tac in plasma over the time interval from 0 extrapolated to infinity).
PK sampling (relative to the first tac administration):
Period 1: for tac 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 144:00h, 168:00h, 192:00h period 2 for tac
-192:00h, -168:00h, 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h"|up to 192 hours (details in description)|pharmacokinetic set of tac (PKS tac): The subject set for the evaluation of PK endpoints was to include all treated subjects who provided at least 1 observation of tac in plasma for at least 1 primary endpoint, and who did not have important protocol violations with respect to the statistical evaluation of PK endpoints.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
651863|NCT02016625|Primary|AUC τ,ss (Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval τ)|"AUC τ,ss (area under the concentration-time curve of the FDV in plasma at steady state over a uniform dosing interval τ).
PK sampling (relative to the first cyclo administration [h:min]):
period 2 For FDV
-144:00h, -120:00h, -96:00h, -72:00h, -48:00h, -24:00h, -23:30h, -23:00h, -22:30h, -22:00h, -21:00h, -20:00h, -18:00h, -16:00h, -14:00h, -12:00h, -8:00h, 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h"|up to 168 hours (details in description)|PKS cyclo + treated with FDV alone (arm: Faldaprevir) or started combination treatment FDV+cyclosporine in treatment period 2.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
651864|NCT02016625|Primary|C24,ss (Maximum Measured Concentration of the FDV in Plasma at Steady State Over a 24 Hour Dosing Interval)|"PK sampling (relative to the first cyclo administration [h:min]):
period 2 For FDV
-144:00h, -120:00h, -96:00h, -72:00h, -48:00h, -24:00h, -23:30h, -23:00h, -22:30h, -22:00h, -21:00h, -20:00h, -18:00h, -16:00h, -14:00h, -12:00h, -8:00h, 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h"|up to 168 hours (details in description)|PKS cyclo + treated with FDV alone (arm: Faldaprevir) or started combination treatment FDV+cyclosporine in treatment period 2.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
651865|NCT02016625|Primary|Cmax,ss (Maximum Measured Concentration of the FDV [Followed by Cyclo Treatment] in Plasma at Steady State Over a Uniform Dosing Interval τ)|"Cmax,ss (maximum measured concentration of the FDV [followed by cyclo treatment] in plasma at steady state over a uniform dosing interval τ).
PK sampling (relative to the first cyclo administration [h:min]):
period 2 For FDV
-144:00h, -120:00h, -96:00h, -72:00h, -48:00h, -24:00h, -23:30h, -23:00h, -22:30h, -22:00h, -21:00h, -20:00h, -18:00h, -16:00h, -14:00h, -12:00h, -8:00h, 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h"|up to 168 hours (details in description)|PKS cyclo + treated with FDV alone (arm: Faldaprevir) or started combination treatment FDV+cyclosporine in treatment period 2.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
651866|NCT02016625|Primary|Cmax (Maximum Measured Concentration of the Cyclo in Plasma)|"Cmax (maximum measured concentration of the cyclo in plasma).
PK sampling (relative to the first cyclo administration [h:min]):
Period 1: for cyclo 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h period 2 for cyclo 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h"|up to 168 hours (details in description)|PKS cyclo||ng/mL||Geometric Coefficient of Variation|Geometric Mean
651867|NCT02016625|Primary|AUC 0-tz (Area Under the Concentration-time Curve of the Cyclo in Plasma Over the Time Interval From 0 to the Last Quantifiable Point)|"AUC 0-tz (area under the concentration-time curve of the cyclo in plasma over the time interval from 0 to the last quantifiable point).
PK sampling (relative to the first cyclo administration [h:min]):
Period 1:
for cyclo 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h period 2 for cyclo 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h."|up to 168 hours (details in description)|PKS cyclo||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
651868|NCT02016625|Primary|AUC 0-infinity (Area Under the Concentration-time Curve of the Cyclo in Plasma Over the Time Interval From 0 Extrapolated to Infinity)|"AUC 0-infinity (area under the concentration-time curve of the cyclo in plasma over the time interval from 0 extrapolated to infinity).
PK sampling (relative to the first cyclo administration [h:min])
Period 1:
for cyclo 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h.
period 2 for cyclo 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h."|up to 168 hours (details in description)|pharmacokinetic set of cyclo (PKS cyclo): The subject set for the evaluation of PK endpoints was to include all treated subjects who provided at least 1 observation of cyclo in plasma for at least 1 primary endpoint, and who did not have important protocol violations with respect to the statistical evaluation of PK endpoints.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
651869|NCT02016482|Secondary|Change From Baseline in Nail Psoriasis Quality of Life (Nail PsQoL) Score at Week 26|Participants were asked how their fingernail psoriasis impacted their overall quality of life over the past 7 days on an 11-point scale, with 0 indicating no impact, and 10 indicating severe impact. A negative change from Baseline indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline and had an assessment. Multiple imputation.||units on a scale||Standard Error|Least Squares Mean
651915|NCT02016105|Secondary|DLQI|Proportion of patients reporting a DLQI of 0 or 1 (no effect at all on patient's life)|At Week 35 only|||% of patients with DLQI of 0 or 1|||Number
651871|NCT02016482|Secondary|Change From Baseline in Hospital Anxiety Depression Scale (HADS) at Week 26|Participants rated their anxiety and depression over the past 7 days at Week 26. The range of possible scores was 0 to 21, with a score of 0 indicating absence of anxiety and depression and 21 indicating the most severe anxiety and depression. A decrease in HADS score indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline; n=number of participants with a given assessment. Multiple imputation.||units on a scale||Standard Error|Least Squares Mean
651872|NCT02016482|Secondary|Change From Baseline in EQ-5D Visual Analogue Scale (VAS) at Week 26|The EQ-5D VAS records the participant's self-rated health status on a vertical graduated scale from 0 to 100, with 0 indicating the worst imaginable health state and 100 indicating the best imaginable health state. An increase in EQ-5D-5L VAS score indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline and had an assessment. Multiple imputation.||units on a scale||Standard Error|Least Squares Mean
651873|NCT02016482|Secondary|Change From Baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Health State Assessment at Week 26|The EQ-5D-5L descriptive system comprises 5 dimensions of health (mobility, self -care, usual activities, pain/discomfort, and anxiety/depression) to describe the subject's current health state. Each dimension comprises 5 levels with corresponding numeric scores, where 1 indicates no problems, and 5 indicates extreme problems. A unique EQ-5D-5L health state is defined by combining the numeric level scores for each of the 5 dimensions and the total score is normalized from –0.594 to 1.000, with higher scores representing a better health state. An increase in the EQ-5D-5L total score indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline and had an assessment. Multiple imputation.||units on a scale||Standard Error|Least Squares Mean
651874|NCT02016482|Secondary|Change From Baseline in Work Productivity and Activity Impairment Nail Psoriasis (WPAI:NPSO) at Week 26|"The WPAI: NPSO assessed impact of fingernail psoriasis on work productivity and non-work activity limitation. Participants were asked during the past 7 days, how many hours did you miss from work because of problems associated with your fingernail psoriasis (absenteeism), during the past seven days, how many hours did you miss from work because of any other reason, such as vacation, holidays, time off to participate in this study (presenteeism), how much did your fingernail psoriasis affect your productivity while you were working (overall work impairment), and much did your fingernail psoriasis affect your ability to do your regular daily activities, other than work at a job (activity impairment). Answers were rated on an 11-point scale, with 0 indicating fingernail psoriasis had no effect on this and 10 indicating fingernail psoriasis completely prevented me from this. A decrease in the WPAI:NPSO score indicates improvement."|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline; n=number of participants with given assessment. Multiple imputation.||units on a scale||Standard Error|Least Squares Mean
651875|NCT02016482|Secondary|Percentage of Participants Achieving DLQI of 0 and 0/1 at Week 26|Participants assessed symptoms and impacts of dermatologic diseases on their QoL over the past 7 days, with 0 indicating not at all, and 3 indicating very much. The range of possible DLQI scores was 0 to 30, with a score of 0 indicating no effect at all on a participant's life and a score of 30 indicating extremely large effect on participant's life. A decrease in DLQI score indicates improvement. Data presents the percentage of participants with a score of 0 (no effect) or 1 (little effect) at Week 26.|Week 26|ITT Population in Period A: all participants who were randomized at Baseline and had an assessment. Multiple imputation.||percentage of participants|||Number
651876|NCT02016482|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 26|Participants assessed symptoms and impacts of dermatologic diseases on their QoL over the past 7 days, with 0 indicating not at all, and 3 indicating very much. The range of possible DLQI scores was 0 to 30, with a score of 0 indicating no effect at all on a participant's life and a score of 30 indicating extremely large effect on participant's life. A decrease in DLQI score indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline and had an assessment. Multiple imputation.||units on a scale||Standard Error|Least Squares Mean
651877|NCT02016482|Secondary|Percent Change From Baseline in Nail Assessment in NAPPA QoL at Week 26|Participants rated specific impacts of fingernail psoriasis on various aspects of their QoL over the past 7 days on a 5-point scale, with 0 indicating not at all, and 4 indicating very impactful. A participant's overall global score was the mean of all items and could range from 0 to 4, with 0 indicating no impact and 4 indicating most impact. A decrease in NAPPA QoL score indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.||percent change||Standard Error|Least Squares Mean
651878|NCT02016482|Secondary|Change From Baseline in Nail Assessment in Psoriasis and Psoriatic Arthritis Quality of Life (NAPPA QoL) at Week 26|Participants rated specific impacts of fingernail psoriasis on various aspects of their QoL over the past 7 days on a 5-point scale, with 0 indicating not at all, and 4 indicating very impactful. A participant's overall global score was the mean of all items and could range from 0 to 4, with 0 indicating no impact and 4 indicating most impact. A decrease in NAPPA QoL score indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.||units on a scale||Standard Error|Least Squares Mean
651879|NCT02016482|Secondary|Percent Change From Baseline in Nail Psoriasis Physical Functioning Severity Score at Week 26|Participants were asked to rate the impact of their fingernail psoriasis on their ability to perform physical tasks (eg, typing, housework, buttoning a shirt or blouse, picking up coins from a table, tying shoes, yard work, etc.) over the past 7 days on a scale of 0 indicating no impact on ability to perform physical tasks, to 10 indicating severe impact on ability to perform physical tasks. A negative change from Baseline indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline and had an assessment (participants with an observed baseline value >0). Multiple imputation.||percent change||Standard Error|Least Squares Mean
651880|NCT02016482|Secondary|Percent Change From Baseline in Nail Psoriasis Pain NRS at Week 26|An NRS was used to capture a participant's self-reporting of her/his worst fingernail pain and average fingernail pain due to fingernail psoriasis. The participant rated the severity of fingernail pain over the past 7 days on a scale from 0 indicating no pain, to 10 indicating severe pain. A negative change from Baseline indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline and had an assessment (participants with an observed baseline value >0). Multiple imputation.||percent change||Standard Error|Least Squares Mean
651881|NCT02016482|Secondary|Percent Change From Baseline in Total BSA at Week 26|BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.||percent change||Standard Error|Least Squares Mean
651882|NCT02016482|Secondary|Change From Baseline in Total Body Surface Area (BSA) at Week 26|BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.||percentage of affected BSA||Standard Error|Least Squares Mean
651883|NCT02016482|Secondary|Percentage of Participants Achieving 50% Improvement in the Inverse Psoriasis Component of the B-SNIPI at Week 26|The range of possible B-SNIPI scores was 0 to 20 for inverse psoriasis, with a score of 0 indicating absence of psoriasis and a score of 20 indicating most severe psoriasis. A decrease in B-SNIPI score indicates improvement. Data presents the percentage of participants achieving 50% improvement in the inverse component of the B-SNIPI among participants with a Baseline inverse psoriasis score of ≥ 6.|Week 26|ITT Population in Period A: all participants who were randomized at Baseline and had Baseline inverse psoriasis score ≥ 6. Inverse psoriasis was assessed for participants enrolled under Protocol Amendment 1 in the US and Puerto Rico only. Multiple imputation.||percentage of participants|||Number
651884|NCT02016482|Secondary|"Percentage of Participants Achieving PGA-S of Clear at Week 26"|"The PGA-S is a 6-point scale used to measure the severity of skin disease at the time of the qualified investigator's evaluation of the participant. The degree of overall lesion severity was assessed, with 0 indicating cleared and 5 indicating severe. A decrease in PGA-S score indicates improvement. Data present the percentage of participants achieving a PGA-S of clear (0) with at least a 2-grade improvement relative to Baseline at Week 26."|Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.||percentage of participants|||Number
651885|NCT02016482|Secondary|"Percentage of Participants Achieving Physician's Global Assessment of Skin Psoriasis (PGA-S) Clear or Minimal at Week 26"|"The PGA-S is a 6-point scale used to measure the severity of skin disease at the time of the qualified investigator's evaluation of the participant. The degree of overall lesion severity was assessed, with 0 indicating cleared and 5 indicating severe. A decrease in PGA-S score indicates improvement. Data present the percentage of participants achieving a PGA-S of clear (0) or minimal (1) with at least a 2-grade improvement relative to Baseline at Week 26."|Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.||percentage of participants|||Number
651886|NCT02016482|Secondary|Percentage of Participants Achieving PASI 75/50/90/100 Responses at Week 26|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 to 72, with 0 indicating no psoriasis and 72 indicating very severe psoriasis. PASI-75, 50, 90, and 100 responses are the percentage of participants with a Baseline PASI score ≥ 5 who achieved at least a 75%, 50%, 90%, or 100% reduction (improvement), respectively, from Baseline in PASI score at Week 26. A 100% reduction was considered complete clearance of psoriasis. Data presents the percentage of participants achieving PASI 75/50/90/100 responses at Week 26 among participants with a Baseline PASI score ≥ 5.|Week 26|ITT Population in Period A: all participants who were randomized at Baseline and had a Baseline PASI score ≥ 5. Multiple imputation.||percentage of participants|||Number
651887|NCT02016482|Secondary|Percent Change From Baseline in PASI Score at Week 26|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 to 72, with 0 indicating no psoriasis and 72 indicating very severe psoriasis. A decrease in PASI score indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.||percent change||Standard Error|Least Squares Mean
651888|NCT02016482|Secondary|Change From Baseline in Psoriasis Area Severity Index (PASI) Score at Week 26|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 to 72, with 0 indicating no psoriasis and 72 indicating very severe psoriasis. A decrease in PASI score indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.||units on a scale||Standard Error|Least Squares Mean
651889|NCT02016482|Secondary|Change From Baseline in Total Fingernail NAPSI Score at Week 26|Each fingernail was assessed for nail matrix psoriasis and nail bed psoriasis with NAPSI and the scores of all 10 fingernails were combined. The range of possible scores was 0 to 80, with a score of 0 indicating absence of nail psoriasis and 80 indicating most severe nail psoriasis. A decrease in NAPSI score indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.||units on a scale||Standard Error|Least Squares Mean
651890|NCT02016482|Secondary|Percent Change From Baseline in Target Fingernail NAPSI Score at Week 26|The target fingernail was assessed for nail matrix psoriasis and nail bed psoriasis with NAPSI. The range of possible scores was 0 to 8, with a score of 0 indicating absence of nail psoriasis and 8 indicating most severe nail psoriasis. A decrease in NAPSI score indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.||percent change||Standard Error|Least Squares Mean
651918|NCT02016105|Secondary|IGA Response Rate|Proportion of patients achieving a score of 0 (“clear”) or 1 (“almost clear”) or improved by at least 2 points of the IGA scale compared to baseline at Week 51|At Week 35 only|||percent of participants|||Number
651891|NCT02016482|Secondary|Change From Baseline in Target Fingernail NAPSI Score at Week 26|The target fingernail was assessed for nail matrix psoriasis and nail bed psoriasis with NAPSI. The range of possible scores was 0 to 8, with a score of 0 indicating absence of nail psoriasis and 8 indicating most severe nail psoriasis. A decrease in NAPSI score indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.||units on a scale||Standard Error|Least Squares Mean
651892|NCT02016482|Secondary|Percentage of Participants Achieving Target Fingernail NAPSI Score of 0 at Week 26|The target fingernail was assessed for nail matrix psoriasis and nail bed psoriasis with NAPSI. The range of possible scores was 0 to 8, with a score of 0 indicating absence of nail psoriasis and 8 indicating most severe nail psoriasis. A decrease in NAPSI score indicates improvement.|Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.||percentage of participants|||Number
651893|NCT02016482|Secondary|Percentage of Participants Achieving Total Fingernail NAPSI Score of 0 at Week 26|Each fingernail was assessed for nail matrix psoriasis and nail bed psoriasis with NAPSI and the scores of all 10 fingernails were combined. The range of possible scores was 0 to 80, with a score of 0 indicating absence of nail psoriasis and 80 indicating most severe nail psoriasis. A decrease in NAPSI score indicates improvement.|Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.||percentage of participants|||Number
651894|NCT02016482|Secondary|Percent Change From Baseline in Total Fingernail mNAPSI Score at Week 26|Each fingernail was assessed for psoriasis with mNAPSI, and the scores of all 10 fingernails were combined. The range of possible scores was 0 to 130, with a score of 0 indicating absence of nail psoriasis and a score of 130 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.||percent change||Standard Error|Least Squares Mean
651895|NCT02016482|Secondary|Change From Baseline in Total Fingernail mNAPSI Score at Week 26|Each fingernail was assessed for psoriasis with mNAPSI, and the scores of all 10 fingernails were combined. The range of possible scores was 0 to 130, with a score of 0 indicating absence of nail psoriasis and a score of 130 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.||units on a scale||Standard Error|Least Squares Mean
651896|NCT02016482|Secondary|Percent Change From Baseline in Target Fingernail mNAPSI Score at Week 26|The target fingernail was assessed for psoriasis with mNAPSI. The range of possible scores was 0 to 13, with a score of 0 indicating absence of nail psoriasis and a score of 13 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.||percent change||Standard Error|Least Squares Mean
651897|NCT02016482|Secondary|Change From Baseline in Target Fingernail mNAPSI Score at Week 26|The target fingernail was assessed for psoriasis with mNAPSI. The range of possible scores was 0 to 13, with a score of 0 indicating absence of nail psoriasis and a score of 13 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.||units on a scale||Standard Error|Least Squares Mean
651898|NCT02016482|Secondary|Percentage of Participants Achieving Total Fingernail mNAPSI Score of ≤ 2 at Week 26|Each fingernail was assessed for psoriasis with mNAPSI, and the scores of all 10 fingernails were combined. The range of possible scores was 0 to 130, with a score of 0 indicating absence of nail psoriasis and a score of 130 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement.|Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.||percentage of participants|||Number
651899|NCT02016482|Secondary|Percentage of Participants Achieving Target Fingernail mNAPSI Score of ≤ 2 at Week 26|The target fingernail was assessed for psoriasis with mNAPSI. The range of possible scores was 0 to 13, with a score of 0 indicating absence of nail psoriasis and a score of 13 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement.|Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.||percentage of participants|||Number
651900|NCT02016482|Secondary|Percentage of Participants Achieving Target Fingernail mNAPSI Score of 0 at Week 26|The target fingernail was assessed for psoriasis with mNAPSI. The range of possible scores was 0 to 13, with a score of 0 indicating absence of nail psoriasis and a score of 13 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement.|Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.||percentage of participants|||Number
651901|NCT02016482|Secondary|"Percentage of Participants Achieving Clear or Minimal in Nail Matrix Component of the PGA-F At Week 26"|"The PGA-F is a 5-point scale used to assess fingernails separately for nail bed signs and nail matrix signs of disease. A global score of between 0 indicating clear, and 4 indicating severe, was separately assigned for nail bed involvement and nail matrix involvement. A participant's overall global score was the worse of the nail bed and nail matrix score. Data presents the percentage of participants with a nail matrix component of the PGA-F that met definition of clear (0) or minimal (1) among those with a Baseline nail matrix component of moderate or worse."|Week 26|"ITT Population in Period A: all participants who were randomized at Baseline and had a Baseline nail matrix component of moderate or worse. Multiple imputations."||percentage of participants|||Number
651902|NCT02016482|Secondary|"Percentage of Participants Achieving Clear or Minimal in Nail Bed Component of the PGA-F at Week 26"|"The PGA-F is a 5-point scale used to assess fingernails separately for nail bed signs and nail matrix signs of disease. A global score of between 0 indicating clear, and 4 indicating severe, was separately assigned for nail bed involvement and nail matrix involvement. A participant's overall global score was the worse of the nail bed and nail matrix score. Data presents the percentage of participants with a nail bed component of the PGA-F that met definition of clear (0) or minimal (1) among those with a Baseline nail bed component of moderate or worse."|Week 26|"ITT Population in Period A: all participants who were randomized at Baseline and had a Baseline nail bed component of moderate or worse. Multiple imputation."||percentage of participants|||Number
652786|NCT01998919|Secondary|Percentage of Participants With Non-Progression at Week 16 as Assessed by RECIST|Non-progression defined as documented best overall tumor response of CR, PR, or SD (where SD was maintained for >16 weeks) per RECIST.|Week 16|FAS||percentage of participants||95% Confidence Interval|Number
651903|NCT02016482|Secondary|Percentage of Participants With at Least 50% Improvement in the Scalp Component of the Brigham Scalp Nail Inverse Palmo-Plantar Psoriasis Index (B-SNIPI) at Week 26|The range of possible scores was 0 to 20 for scalp psoriasis, with a score of 0 indicating absence of psoriasis. A decrease in B-SNIPI score indicates improvement. Data presents the percentage of participants achieving 50% improvement in the scalp component of the B-SNIPI among participants with Baseline scalp score of ≥ 6.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Scalp psoriasis was assessed by B-SNIPI at Week 26 for participants enrolled under Protocol Amendment 1 in the US and Puerto Rico only. Multiple imputation.||percentage of participants|||Number
651904|NCT02016482|Secondary|Change From Baseline in Nail Psoriasis Physical Functioning Severity Score at Week 26|Participants were asked to rate the impact of their fingernail psoriasis on their ability to perform physical tasks (eg, typing, housework, buttoning a shirt or blouse, picking up coins from a table, tying shoes, yard work, etc.) over the past 7 days on a scale of 0 indicating no impact on ability to perform physical tasks, to 10 indicating severe impact on ability to perform physical tasks. A negative change from Baseline indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline.||units on a scale||Standard Error|Least Squares Mean
651905|NCT02016482|Secondary|Percent Change From Baseline in Nail Psoriasis Pain Numeric Rating Scale (NRS) at Week 26|An NRS was used to capture a participant's self-reporting of her/his worst fingernail pain and average fingernail pain due to fingernail psoriasis. The participant rated the severity of fingernail pain over the past 7 days on a scale from 0 indicating no pain, to 10 indicating severe pain. A negative change from Baseline indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline.||percent change||Standard Error|Least Squares Mean
651906|NCT02016482|Secondary|Percentage of Participants Achieving Total Fingernail mNAPSI Score of 0 at Week 26|Each fingernail was assessed for psoriasis with mNAPSI, and the scores of all 10 fingernails were combined. The range of possible scores was 0 to 130, with a score of 0 indicating absence of nail psoriasis and a score of 130 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement.|Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.||percentage of participants|||Number
651907|NCT02016482|Secondary|Percent Change From Baseline in Total Fingernail Nail Psoriasis Severity Index (NAPSI) Score at Week 26|Each fingernail was assessed for nail matrix psoriasis and nail bed psoriasis with NAPSI and the scores of all 10 fingernails were combined. The range of possible scores was 0 to 80, with a score of 0 indicating absence of nail psoriasis and 80 indicating most severe nail psoriasis. A decrease in NAPSI score indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline.||percent change||Standard Error|Least Squares Mean
651908|NCT02016482|Primary|"For United States (US) Regulatory Purposes: Percentage of Participants With a Physician's Global Assessment of Fingernails (PGA-F) of Clear or Minimal at Week 26"|"The PGA-F is a 5-point scale used to assess fingernails separately for nail bed signs and nail matrix signs of disease. A global score of between 0 indicating clear, and 4 indicating severe, was separately assigned for nail bed involvement and nail matrix involvement. A participant's overall global score was the worse of the nail bed and nail matrix score. Data presents the percentage of participants with a PGA-F overall global score that met the definition of “clear” (0) or “minimal (1) with at least a 2-grade improvement relative to Baseline at Week 26."|Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.||percentage of participants|||Number
651909|NCT02016482|Primary|Percentage of Participants Achieving a Total Fingernail Modified Nail Psoriasis Severity Index (mNAPSI) 75 Response at Week 26|Each fingernail was assessed for psoriasis with mNAPSI, and the scores of all 10 fingernails were combined. Investigators assessed each nail abnormality for each of a participant's nails by grading 3 features or groups of features (pitting, onycholysis and oil-drop dyschromia, and crumbling) and noting the presence or absence of 4 features (leukonychia, splinter hemorrhages, hyperkeratosis, and red spots in the lunula). The range of possible scores was 0 to 130, with a score of 0 indicating absence of nail psoriasis and a score of 130 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement. The mNAPSI 75 response is defined as at least 75% reduction from baseline in mNAPSI.|Week 26|Intent-to-treat (ITT) Population in Period A: all participants who were randomized at Baseline.||percentage of participants|||Number
651910|NCT02016170|Secondary|Platelet Reactivity Index (PRI) Measured by Whole Blood Vasodilator-stimulated Phosphoprotein (VASP).|The secondary hypothesis of our study was that after 1 week of randomized treatment PRI levels would be non-inferior in patients switched from prasugrel to ticagrelor (two arms combined) compared with patients remaining on prasugrel. VASP was measured by quantitative flow cytometry using commercially available labelled monoclonal antibodies.|7 days|||PRI||Standard Deviation|Least Squares Mean
651911|NCT02016170|Primary|Platelet Reactivity Measured as P2Y12 Reaction Units (PRU) Determined by Verify Now-P2Y12 Assay|The primary hypothesis of our study was that after 1 week of randomized treatment PRU levels would be non-inferior in patients switched from prasugrel to ticagrelor (two arms combined) compared with patients remaining on prasugrel.|7 days|Analysis was conducted in patients who received the randomized treatment and had a valid primary end point value (PRU at 1 week).||PRU||Standard Error|Least Squares Mean
651912|NCT02016105|Secondary|ADA Formation Against GP2017 Adalimumab and Humira® Adalimumab From Randomization Until Week 51|"Proportion of patients with at least one confirmed positive anti-drug antibodies (ADA) response to adalimumab from Randomization to Week 51.
Patients with ADA positive results at baseline were excluded from subsequent results."|At Week 51 only|The Safety analysis set (SAF) includes all patients who received at least one dose of study treatment during Treatment Period 1. Patients were analyzed according to the treatment received.||% patients with at least 1 ADA+ sample|||Number
651913|NCT02016105|Secondary|ADA Formation Against GP2017 Adalimumab and Humira® Adalimumab From Randomization Until Week 17|"Proportion of patients with at least one confirmed positive anti-drug antibodies (ADA) response to adalimumab from Randomization to Week 17.
Patients with ADA positive results at baseline were excluded from subsequent results."|At Week 17 only|The Safety analysis set (SAF) includes all patients who received at least one dose of study treatment during Treatment Period 1. Patients were analyzed according to the treatment received.||% patients with at least 1 ADA+ sample|||Number
651914|NCT02016105|Secondary|DLQI|Proportion of patients reporting a DLQI of 0 or 1 (no effect at all on patient's life)|At Week 51 only|||% of patients with DLQI of 0 or 1|||Number
651919|NCT02016105|Secondary|IGA Response Rate|Proportion of patients achieving a score of 0 (“clear”) or 1 (“almost clear”) or improved by at least 2 points of the IGA scale compared to baseline at Week 17.|At Week 17 only|The Per-protocol analysis set (PPS) consists of patients who completed the study up to Week 16 and had no major protocol deviations or additional exclusion criteria up to and including Week 16.||percent of participants|||Number
651920|NCT02016105|Secondary|PASI 50, PASI75, PASI 90 and PASI100 Response Rates|Proportion of Patients Achieving PASI 50, 75, 90 and 100 at Week 51 (Entire Study)|At Week 51 only|||percent of participants|||Number
651921|NCT02016105|Secondary|PASI 50, PASI75, PASI 90 and PASI100 Response Rates|Proportion of Patients Achieving PASI 50, 75, 90 and 100 at Week 35 (end of Treatment Period 2)|At Week 35 only|||percent of participants|||Number
651922|NCT02016105|Secondary|PASI 50, PASI 75, PASI 90 and PASI 100 Response Rates|Proportion of patients achieving PASI 50, 75, 90 and 100 at Week 17 (end of Treatment Period 1)|At Week 17 only|The Per-protocol analysis set (PPS) consists of patients who completed the study up to Week 16 and had no major protocol deviations or additional exclusion criteria up to and including Week 16.||percent of participants|||Number
651923|NCT02016105|Secondary|Mean ATE of Percent Change From Baseline in PASI Score up to Week 16 (ANCOVA)|The key secondary efficacy variable was the average treatment effect (ATE) which is the weighted average of % change from baseline in PASI scores between Week 1 and Week 16 (weights based on the time interval between two consecutive visits).|Baseline to Week 16|The Per-protocol analysis set (PPS) consists of patients who completed the study up to Week 16 and had no major protocol deviations or additional exclusion criteria up to and including Week 16.||percentage change from baseline||Standard Error|Least Squares Mean
651924|NCT02016105|Secondary|Mean Percent Change From Baseline in PASI Score up to Week 16 (MMRM)|The key secondary efficacy variable was the percentage change from baseline in PASI score at each visit up to Week 16.|Baseline to Week 16|The Per-protocol analysis set (PPS) consists of patients who completed the study up to Week 16 and had no major protocol deviations or additional exclusion criteria up to and including Week 16.||percentage change from baseline||Standard Error|Least Squares Mean
651925|NCT02016105|Primary|PASI 75 Response Rate at Week 16 - GP2017 Adalimumab vs Humira ® Adalimumab|The primary variable was the PASI75 response rate at Week 16, defined as the proportion of patients achieving a reduction of 75% or more of the PASI score at Week 16 compared with baseline.|At Week 16 only|The Per-protocol analysis set (PPS) consists of patients who completed the study up to Week 16 and had no major protocol deviations or additional exclusion criteria up to and including Week 16.||percent of participants|||Number
651926|NCT02015910|Primary|Percent Wounds Healed|Compare the rate of healing as well as percent of wounds healed in Type II diabetic patients with chronic foot ulcerations receiving sitagliptin versus placebo.|12 weeks|Data analysis not completed due to insufficient enrollment.|||||
651927|NCT02015793|Other Pre-specified|Number of Subjects Positive for Anti-Adalimumab Antibodies (AAA) From Baseline to Week 8|Serum samples with adalimumab concentration below 2 μg/mL were selected for AAA analyses. Samples were considered AAA positive if the measured AAA concentration was above 2 μg/mL. A subject was considered to be AAA positive if the subject had at least one AAA positive sample observed within 30 days following the subject's last adalimumab dose. No samples were tested because all samples had adalimumab concentrations >2 μg/mL.|Baseline (Week 0) to Week 8|ITT population.|||||
651928|NCT02015793|Secondary|Fecal Calprotectin: Change From Baseline (Week 0) to Week 8|Stool samples for fecal calprotectin were collected before study drug administration when possible. Decreases in calprotectin are associated with decreased inflammation in the gastrointestinal tract. LOCF was used for missing data.|Baseline (Week 0) and Weeks 4 and 8|ITT population.||μg/g||Full Range|Median
651929|NCT02015793|Secondary|High-sensitivity C-reactive Protein (hsCRP): Median Change From Baseline (Week 0) to Week 26|hsCRP was measured from blood samples as a marker for inflammation. Higher levels are indicative of more inflammation. Normal concentration in healthy human serum is usually lower than 3 mg/L, slightly increasing with age. LOCF was used for missing data.|Baseline (Week 0) and Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, and 26|ITT population.||mg/L||Full Range|Median
651930|NCT02015793|Secondary|CDAI: Mean Change From Baseline to Each Visit|CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease. Scores range from 0 to approximately 600. A score below 150 indicates remission and a score of 220 to 450 reflects moderate to severe disease. Last observation carried forward (LOCF) for missing CDAI observations was used.|Baseline (Week 0) and Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26|ITT population.||units on a scale||Standard Deviation|Mean
651931|NCT02015793|Secondary|Percentage of Participants Who Achieved Clinical Response (CDAI Decrease ≥ 70 From Week 0) Every 2 Weeks up to Week 26|CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score of 220 to 450 reflects moderate to severe disease. Non-responder imputation (NRI) for missing CDAI observations was used.|Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26|ITT population.||percentage of participants||95% Confidence Interval|Number
651932|NCT02015793|Secondary|Percentage of Participants Who Achieved Clinical Remission (Crohn's Disease Activity Index [CDAI] < 150) Every 2 Weeks up to Week 26|CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score of 220 to 450 reflects moderate to severe disease. Non-responder imputation (NRI) for missing CDAI observations was used.|Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26|ITT population.||percentage of participants||95% Confidence Interval|Number
651933|NCT02015793|Secondary|Number of Participants With Adverse Events (AEs)|"An AE is any untoward medical occurrence in a participant which does not necessarily have a causal relationship with this treatment. A serious AE (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs or TESAE) are defined as any event that began or worsened in severity after the first dose of study drug. The investigator assessed the relationship of each event to the use of study drug as either Reasonable possibility or No reasonable possibility of being related to study drug.
For more details on adverse events please see the AE section below."|35 weeks|Safety Analysis Set.||participants|||Number
655262|NCT01953328|Secondary|Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
651934|NCT02015793|Secondary|Number of Participants With Potentially Significant Vital Signs Parameters During Administration of Adalimumab|Blood pressure and pulse were measured while the participant was sitting. The number of participants with a postbaseline vital sign result that meets Common Toxicity Criteria (CTC) version 3.0 (or later) Grade 3 or higher and is also more extreme than the baseline value is summarized. Terms abbreviated in the table include systolic blood pressure (SBP) and diastolic blood pressure (DBP). Increase and decrease are signified by ↑ and ↓, respectively.|26 weeks|Safety Analysis Set.||participants|||Number
651935|NCT02015793|Secondary|Number of Participants With Potentially Significant Clinical Chemistry Parameters During Administration of Adalimumab|The number of participants with an abnormal laboratory result meeting Common Toxicity Criteria (CTC) Version 3.0 (or later) of Grade 3 or higher is summarized.|From Week 0 to Week 26|Safety Analysis Set.||participants|||Number
651936|NCT02015793|Secondary|Number of Participants With Potentially Significant Hematology Parameters During Administration of Adalimumab|The number of participants with an abnormal laboratory result meeting Common Toxicity Criteria (CTC) Version 3.0 (or later) of Grade 3 or higher is summarized. n=the number of participants with CTC Grade <3 at baseline and a post-baseline value for each parameter.|26 weeks|Safety Analysis Set: all participants who received at least 1 dose of study drug.||participants|||Number
651937|NCT02015793|Primary|Mean Serum Adalimumab Concentration at Week 8|Blood samples were drawn prior to drug administration. Adalimumab concentrations in serum were determined using a validated enzyme-linked immunosorbent assay (ELISA) method.|Week 8|All participants in the intent-to-treat (ITT) population, defined as all randomized participants who received at least 1 dose of double-blind study drug, who had evaluable data.||μg/mL||Standard Deviation|Mean
651938|NCT02015676|Secondary|Overall Survival|The time, in months, from the start of treatment to OS event. The mean survival time and it's standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time.|BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)|All participants enrolled in Phase II of this study were included in the analysis.||months||Standard Error|Mean
651939|NCT02015676|Secondary|Overall Survival (OS) - Percentage of Participants With an Event|OS was defined as the time from the date of the start of treatment to the date of death or the last date the participant was known to be alive.|BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)|All participants enrolled in Phase II of this study were included in the analysis.||percentage of participants|||Number
651940|NCT02015676|Secondary|Time to Therapy Failure|The median time, in months, from treatment start to therapy failure event. Participants were censored at the last date of treatment if no event was recorded.|BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)|All participants enrolled in Phase II of this study were included in the analysis.||months||95% Confidence Interval|Median
651941|NCT02015676|Secondary|Time to Therapy Failure - Percentage of Participants With an Event|Therapy failure was defined as the date of the start of therapy to the date of withdrawal due to adverse events, progressive disease/insufficient therapeutic response, death, failure to return, or refusal of treatment/lack of cooperation/withdrawal of consent. Participants were censored at the last dose of treatment if no event was recorded.|BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)|All participants enrolled in Phase II of this study were included in the analysis.||percentage of participants|||Number
651942|NCT02015676|Secondary|Duration of Response|The median time, in months, from enrollment to duration of response event to Week 52.|BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)|All participants enrolled in Phase II of this study were included in the analysis.||months||95% Confidence Interval|Median
651943|NCT02015676|Secondary|Duration of Response - Percentage of Participants With an Event|Duration of response was defined as the time from date CR was first recorded to the date progressive disease (PD) was first noted. For measurable disease, PD was defined as a ≥25% increase in the sum of the products of diameters of 1 or more measurable lesions with a minimal area of >2 cm^2, or the appearance of new lesions; and for malignant lesions with a minimal area of 2 cm^2, an increase of ≥1 cm^2. For immeasurable disease, PD was defined as the appearance of any new lesion not previously identified or an estimated increase of ≥50% in existent lesions.|BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)|Only participants with a response were included in the analysis.||percentage of participants|||Number
651944|NCT02015676|Secondary|Time to Treatment Response|The median time, in months, from the start of treatment to treatment response event.|BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)|All participants enrolled in Phase II of this study were included in the analysis.||months||95% Confidence Interval|Median
651945|NCT02015676|Secondary|Time to Treatment Response - Percentage of Participants With an Event|Treatment response was defined as the time from the start of treatment to the date of recorded CR or PR of measurable disease.|BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)|All participants enrolled in Phase II of this study were included in the analysis.||percentage participants|||Number
651946|NCT02015676|Secondary|Time to Disease Progression|The median time, in months, from the start of treatment to disease progression event.|BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)|All participants enrolled in Phase II of this study were included in the analysis.||months||95% Confidence Interval|Median
651947|NCT02015676|Secondary|Time to Disease Progression - Percentage of Participants With an Event|Disease progression was defined as the time from the start of treatment to the date of the first recorded incident of disease progression, or the date of death due any cause. For measurable disease, disease progression was defined as a ≥25% increase in the sum of the products of diameters of 1 or more measurable lesions with a minimal area of greater than (>)2 square centimeters (cm^2), or the appearance of new lesions; and for malignant lesions with a minimal area of 2 cm^2, an increase of ≥1 cm^2. For immeasurable disease, disease progression was defined as the appearance of any new lesion not previously identified or an estimated increase of ≥50% in existent lesions.|BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)|All participants enrolled in Phase II of this study were included in the analysis.||percentage of participants|||Number
652812|NCT01998880|Primary|Percentage of Participants With Progression Free Survival Events|Percentage of Participants with Progression Free Survival Events: progression, relapse, or death.|Randomization to clinical cutoff (median observation 15.2 months)|Intent-to-treat population included all randomized participants.||Percentage of participants|||Number
651948|NCT02015676|Primary|Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) According to World Health Organization (WHO) Handbook for Reporting Results of Cancer Treatment|For measurable disease, CR was defined as the disappearance of all clinically detectable disease determined by 2 observations not less than 4 weeks apart; and PR was defined as a 50 percent (%) decrease in the sum of the products of the 2 greatest diameters of all measurable lesions by 2 observations not less than 4 weeks apart, and no appearance of new lesions or progression of any lesion. For immeasurable disease, CR was defined as the complete disappearance of all known disease for at least 4 weeks; and PR was defined as an estimated decrease in tumor size of 50% or more for at least 4 weeks.|Baseline (BL), Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)|All participants enrolled in Phase II of this study were included in the analysis.||percentage of participants|||Number
651949|NCT02015663|Secondary|Change From Baseline in Tobramycin Minimal Inhibitory Concentration for Pseudomonas Aeruginosa|Change from baseline in tobramycin minimal inhibitory concentration for Pseudomonas aeruginosa will be measured by laboratory testing.|Baseline and day 168|The study intended to randomize 200 patients within 18 months; however, after 9 months, only 32 patients were successfully randomized, with a screen fail rate of 50%. Study was terminated with only safety data analyzed. No data collected met the pre-specified powering of 200 patients needed for analysis (only 32 patients randomized)|||||
651950|NCT02015663|Secondary|Duration of Use of Anti-pseudomonal Antibiotic|Number of days of use of anti-pseudomonal antibiotic per patient will be assessed.|Day 1 to day 168|The study intended to randomize 200 patients within 18 months; however, after 9 months, only 32 patients were successfully randomized, with a screen fail rate of 50%. Study was terminated with only safety data analyzed. No data collected met the pre-specified powering of 200 patients needed for analysis (only 32 patients randomized)|||||
651951|NCT02015663|Secondary|Percentage of Patients Who Use Anti-pseudomonal Antibiotic|Percentage of patients who use anti-pseudomonal antibiotic will be assessed.|Day 1 to day 168|The study intended to randomize 200 patients within 18 months; however, after 9 months, only 32 patients were successfully randomized, with a screen fail rate of 50%. Study was terminated with only safety data analyzed. No data collected met the pre-specified powering of 200 patients needed for analysis (only 32 patients randomized)|||||
651952|NCT02015663|Secondary|Time to First Usage of Anti-pseudomonal Antibiotic|Time to first usage of anti-pseudomonal antibiotic per patient will be assessed by number of days|Day 1 to day 168|The study intended to randomize 200 patients within 18 months; however, after 9 months, only 32 patients were successfully randomized, with a screen fail rate of 50%. Study was terminated with only safety data analyzed. No data collected met the pre-specified powering of 200 patients needed for analysis (only 32 patients randomized)|||||
651953|NCT02015663|Secondary|Length of Hospital Stay Due to Respiratory-related Events|The number of days in length of hospital stay per patient due to respiratory-related events will be measured.|Day 1 to day 168|The study intended to randomize 200 patients within 18 months; however, after 9 months, only 32 patients were successfully randomized, with a screen fail rate of 50%. Study was terminated with only safety data analyzed. No data collected met the pre-specified powering of 200 patients needed for analysis (only 32 patients randomized)|||||
651954|NCT02015663|Secondary|Percentage of Patients With Hospitalizations Due to Respiratory-related Events|Percentage of patients with hospitalization due to respiratory-related events|Day 1 to day 168|The study intended to randomize 200 patients within 18 months; however, after 9 months, only 32 patients were successfully randomized, with a screen fail rate of 50%. Study was terminated with only safety data analyzed. No data collected met the pre-specified powering of 200 patients needed for analysis (only 32 patients randomized)|||||
651955|NCT02015663|Secondary|Time to First Hospitalization Due to Respiratory-related Events|Time to the first hospitalization due to respiratory-related events (number of days) per patient.|Day 1 to day 168|The study intended to randomize 200 patients within 18 months; however, after 9 months, only 32 patients were successfully randomized, with a screen fail rate of 50%. Study was terminated with only safety data analyzed. No data collected met the pre-specified powering of 200 patients needed for analysis (only 32 patients randomized)|||||
651956|NCT02015663|Secondary|Change From Baseline in Pseudomonas Aeruginosa Sputum Density|Change from baseline in Pseudomonas aeruginosa sputum density will be measured by log10 colony forming units per gram of sputum.|Baseline and day 168|The study intended to randomize 200 patients within 18 months; however, after 9 months, only 32 patients were successfully randomized, with a screen fail rate of 50%. Study was terminated with only safety data analyzed. No data collected met the pre-specified powering of 200 patients needed for analysis (only 32 patients randomized)|||||
651957|NCT02015663|Secondary|Percent Change From Baseline in Forced Expiratory Flow (FEF) 25%-75% Predicted|The Forced Expiratory Flow (FEF) 25%-75% measurement describes the amount of air expelled from the lungs during the middle half (25% - 75%) of the forced vital capacity test and is measured using spirometry. A positive change from baseline in FEF indicates improvement in lung function. The predicted percent will be assessed.|Baseline and day 168|The study intended to randomize 200 patients within 18 months; however, after 9 months, only 32 patients were successfully randomized, with a screen fail rate of 50%. Study was terminated with only safety data analyzed. No data collected met the pre-specified powering of 200 patients needed for analysis (only 32 patients randomized)|||||
651958|NCT02015663|Secondary|Percent Change From Baseline in Forced Vital Capacity (FVC) Percent Predicted|Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC will be assessed via spirometry. A positive change from baseline in FVC indicates improvement in lung function.|Baseline and Day 168|The study intended to randomize 200 patients within 18 months; however, after 9 months, only 32 patients were successfully randomized, with a screen fail rate of 50%. Study was terminated with only safety data analyzed. No data collected met the pre-specified powering of 200 patients needed for analysis (only 32 patients randomized)|||||
652031|NCT02014584|Secondary|Number of Participants Who Discontinued Study Treatment Due to AEs Related to Sexual Function in the Open-label Treatment Period|An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders.|24 weeks|Open-Label Period Population||Participants|||Number
652832|NCT01998399|Secondary|Myocardial Infarction|Did the patient have a myocardial infarction during the 90 day study?|90 days||||||
651959|NCT02015663|Secondary|Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Percent Predicted|"The Forced Expiratory Volume in 1 second (FEV1) percent predicted expresses FEV1 as a percentage of the predicted values for participants of similar characteristics (height, age, sex, and sometimes race and weight). A positive change from baseline in FEV1 percent predicted indicates improvement in lung function."|Baseline and Day 168|The study intended to randomize 200 patients within 18 months; however, after 9 months, only 32 patients were successfully randomized, with a screen fail rate of 50%. Study was terminated with only safety data analyzed. No data collected met the pre-specified powering of 200 patients needed for analysis (only 32 patients randomized)|||||
651960|NCT02015663|Primary|Change From Baseline in Forced Expiratory Volume in 1 Second ( FEV1) Percent Predicted|"The Forced Expiratory Volume in 1 second (FEV1) percent predicted expresses FEV1 as a percentage of the predicted values for participants of similar characteristics (height, age, sex, and sometimes race and weight). A positive change from baseline in FEV1 percent predicted indicates improvement in lung function."|Baseline and Day 168|The study intended to randomize 200 patients within 18 months; however, after 9 months, only 32 patients were successfully randomized, with a screen fail rate of 50%. Study was terminated with only safety data analyzed. No data collected met the pre-specified powering of 200 patients needed for analysis (only 32 patients randomized)|||||
651961|NCT02015546|Secondary|MADRS Remission|MADRS remission is defined as MADRS score < 10|Week 8|||participants|||Number
651962|NCT02015546|Secondary|MADRS Response|Number of subjects who had a ≥ 50% decrease in MADRS score from baseline|Baseline, Week 8|||participants|||Number
651963|NCT02015546|Secondary|Change in Clinical Global Impression-Severity (CGI-S) Scale|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher scores indicate worsening."|Baseline, 8 week|||units on a scale||Standard Deviation|Mean
651964|NCT02015546|Secondary|Change in Clinical Global Impression-Improvement (CGI-I) Scale|The CGI-I is a 7-point scale that requires the clinician to assess how much the participant’s illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.|Baseline, Week 8|||units on a scale||Standard Deviation|Mean
651965|NCT02015546|Secondary|Change in Sheehan Disability Scale (SDS)|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment.|Baseline, 8 week|||units on a scale||Standard Deviation|Mean
651966|NCT02015546|Secondary|Change in Hamilton Anxiety Rating Scale (HAM-A) Total Scores|HAM-A=clinician-rated interview measuring presence of anxiety-related symptoms in 14 areas including anxiety, tension, depressed mood, palpitations, breathing difficulties, sleep disturbances, & restlessness. Total score ranges from 0 to 56; higher score indicates greater anxiety.|Baseline, 8 weeks|||units on a scale||Standard Deviation|Mean
651967|NCT02015546|Primary|Change in Safety as Assessed by the Arizona Sexual Experience Scale (ASEX)|"The Arizona Sexual Experience Scale (ASEX) is a 5-item, patient selfrated scale that evaluates a patient's recent sexual experience. Patients are asked to assess their own experience over the last week (for example, How strong is your sex drive?, Are your orgasms satisfying?) and respond on a 6-point scale for each item. The ASEX is used to identify individuals with sexual dysfunction. Possible total score ranges from 5 to 30, with the higher score indicating more patient sexual dysfunction."|Baseline, Weeks 8|||units on a scale||Standard Deviation|Mean
651968|NCT02015546|Primary|Change in the Discontinuation Emergent Signs and Symptoms Check List (DESS)|"DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The primary tolerability measure for discontinuation symptoms will be The Discontinuation Emergent Signs and Symptoms Check List (DESS). Discontinuation symptoms that do not respond to education and supportive psychotherapy will be managed by reinstituting the last dose of Vilazodone at which patients did not experience discontinuation symptoms and slowly tapering the dose over 1 week or longer, if necessary.
Total possible range is 0 to 172. A higher score indicates more symptoms."|Baseline, week 9|||units on a scale||Standard Deviation|Mean
651969|NCT02015546|Primary|Change in Total MADRS Scores From Baseline to Week 8|The efficacy of switching to three different doses of vilazodone (10 mg/d, 20 mg/d, 40 mg/d) from equivalent dose range of generic SSRIs or SSNRIs in patients with MDD measured by the MADRS. The MADRS is a 10-item scale that evaluates the core symptoms and cognitive features of clinical depression. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms.|Baseline, Week 8|||units on a scale||Standard Deviation|Mean
652032|NCT02014584|Secondary|Number of Participants Who Discontinued Study Treatment Due to AEs Related to Sexual Function in the Double-blind Treatment Period|An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders.|24 weeks|Safety Population||Participants|||Number
652833|NCT01998399|Secondary|Composite Endpoint: Stroke, Myocardial Infarct, Mortality||90 days||||||
651974|NCT02015234|Secondary|Responder Analysis of Patient's Global Impression of Change (PGIC)|"PGIC is a fibromyalgia-specific validated instrument to gauge the patient's assessment of change in condition.The scores are categorized as provided below. A responder was defined by a score of 1 (very much improved), or 2 (much improved).
= Very much improved
= Much improved
= Minimally improved
= No change
= Minimally worse
= Much worse
= Very much worse"|Months 1, 3, 6, 9, 12|Patients who took at least 1 dose of study drug prior to study discontinuation were included in the efficacy analysis. Overall, 36 patients from the Placebo - TNX-102 SL group and 25 patients from the TNX-102 SL - TNX-102 SL group had discontinued the study early. Any missing PGIC responses were included in the “scores 3-7” for that visit.||Participants|||Count of Participants
651975|NCT02015234|Secondary|Change From Baseline in Numerical Rating Scale (NRS) Assessments of Average Pain Based on a 7 Day Recall|The NRS for average pain over the past 7 days was an 11-point scale (0=no pain → 10=worst pain imaginable) that was assessed on a 7-day recall basis.|Month 1, 3, 6, 9, 12|Patients who took at least 1 dose of study drug prior to study discontinuation were included in the efficacy analysis. By the end of the study, 36 patients from the Placebo - TNX-102 SL group and 25 patients from the TNX-102 SL - TNX-102 SL group had discontinued the study.||Scores on a scale||Standard Deviation|Mean
651976|NCT02015234|Secondary|Change From Baseline in Numerical Rating Scale (NRS) Assessments of Average Pain Based on 24 Hour Recall|The NRS for average pain was an 11-point scale (0=no pain → 10=worst pain imaginable) that was assessed on a 24-hour recall basis.|Months 1, 3, 6, 9 and 12.|Patients who took at least 1 dose of study drug prior to study discontinuation were included in the efficacy analysis. By the end of the study, 36 patients from the Placebo - TNX-102 SL group and 25 patients from the TNX-102 SL - TNX-102 SL group had discontinued the study.||Scores on a scale||Standard Deviation|Mean
651977|NCT02015234|Primary|Newly-emergent Adverse Events (NEAEs) During Treatment With TNX-102 SL Tablets Taken Daily at Bedtime Over 12 Months in Patients With Fibromyalgia.|NEAEs and Serious Adverse events (SAEs) were collected and are coded using the latest version of the Medical Dictionary for Regulatory Activities (MedDRA).|Up to 12 months|All of the 158 enrolled patients took at least 1 dose of study drug and were included in the safety analysis population.||Participants|||Count of Participants
651978|NCT02015221|Primary|Ease of Use and Comfort for Subjects Using the ACTitouch System.|Ease of application and removal (donning and doffing) the treatment at the baseline visit. Comfort of treatment after the treatment was first applied.|30 days|||Percent of participants|Participants|95% Confidence Interval|Number
651979|NCT02015195|Primary|Mean Change in Erythema (Redness) in the Treated Human Arm (Not Placebo) From Baseline Determined by Measures (3) Taken Over 24 Hours|"Visual inspection of sting sites will be done at 30 minutes post sting (after treatment completed), 1 hour post sting, and 24 hours post sting. Erythema Index (EI) imeasures increase in cutaneous vasodilation. A computer-measured (Image-J software) EI was used to remove subjectivity. A numeric score was created for the level of erythema, with 0 representing baseline erythema on the control arm. Any positive number indicates more and negative number less erythema on treatment arm compared to placebo. EI values were measured on a scale from -20 to +20 with 0 being the midpoint where there would be equal amounts of erythema on both the treatment and control arm. The erythema they experienced on the treatment arm was then measured as more erythema (a positive value up to 20) or less erythema (a negative value up to -20)."|30 minutes, 1 hour, and 24 hours|||units on a scale||95% Confidence Interval|Mean
651980|NCT02015195|Primary|Mean Change in Pain in the Treated Human Arm (Not Placebo) From Baseline Determined by Measures (17) Taken Over 24 Hours|"Pain is measured on a scale of 1-10 with 0 being no pain and 10 being worse pain ever felt. Baseline pain will be measured immediately after being stung for 2 minutes without any treatment. Subsequent pain felt at every 2 minutes for 30 minutes, at 1 hour post sting, and at 24 hours post sting will be based on changes from the original baseline pain. Mean change is defined as the mean change in pain from all time points measured from each participant and then averaged for each group. The control arm (placebo) was collected and analyzed in parallel to the treatment arm. The mean change for the treatment arm was then compared with the mean change for the control arm as a baseline. Hence, the data presented are the estimated effect for each treatment group compared to the control arms for each group."|24 hours|one participant excluded because of adverse local skin reaction to household ammonia||units on a scale||95% Confidence Interval|Mean
651981|NCT02014584|Secondary|Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period|The global assessment questions consist of 2 questions, recording how much the participant perceives his sexual life has changed and how he perceives his ability to achieve and maintain erections has changed, compared to how it was before he began receiving treatment in this study. The wording of these questions were based on the Patient Global Impression of Improvement questionnaire, which was validated for use in the assessment of improvement in stress urinary incontinence. The questions were scored on a 7-point scale.The Baseline assessment was defined as the latest assessment on or before the OL treatment start.|Baseline and up to Week 24|open-label period population||Participants|||Number
651982|NCT02014584|Secondary|Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions in the Double-blind Treatment Period|The global assessment questions consist of 2 questions, recording how much the participant perceives his sexual life has changed and how he perceives his ability to achieve and maintain erections has changed, compared to how it was before he began receiving treatment in this study. The wording of these questions were based on the Patient Global Impression of Improvement questionnaire, which was validated for use in the assessment of improvement in stress urinary incontinence. The questions were scored on a 7-point scale.The Baseline assessment was defined as the latest assessment on or before the DB treatment start.|Baseline and up to Week 24|Safety Population||Participants|||Number
651983|NCT02014584|Secondary|Change From Baseline in the Total Score of the DLQI in the Open-label Treatment Period|The DLQI was a 10-item questionnaire designed to evaluate the effect of skin conditions (alopecia) on the participants quality of life. Each item was scored on a 4-point scale ranging from 0 to 3 with a maximum score of 30. Higher scores represent greater impairment in quality of life. The Baseline assessment was defined as the latest assessment on or before the OL treatment start. Change from Baseline is post-Baseline value minus Baseline value.|Baseline and Upto Week 24|Open-label Period Population||Scores on a Scale||Standard Deviation|Mean
652834|NCT01998399|Secondary|Stroke|Did the patient develop a stroke during the 90 day study?|90 days||||||
651984|NCT02014584|Secondary|Change From Baseline in the Total Score of the Dermatology Life Quality Index (DLQI) in the Double-blind Treatment Period|The DLQI was a 10-item questionnaire designed to evaluate the effect of skin conditions (alopecia) on the participants quality of life. Each item was scored on a 4-point scale ranging from 0 to 3 with a maximum score of 30. Higher scores represent greater impairment in quality of life. The Baseline assessment was defined as the latest assessment on or before the DB treatment start. Change from Baseline is post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 12 and Week 24|Safety Population||Scores on a Scale||Standard Error|Least Squares Mean
651985|NCT02014584|Secondary|Change From Baseline in Participant Satisfaction With Hair Growth as Assessed by the Total Score of the HGSS in the Open-label Treatment Period|The HGSS assessed participants satisfaction with hair appearance and growth by scoring 5 questions on a 7-point scale ranging from 1=very dissatisfied to 7=very satisfied with a maximum score of 35. The Baseline assessment was defined as the latest assessment on or before the OL treatment start. Change from Baseline is post-Baseline value minus Baseline value. A decrease from Baseline indicates a worsening. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 24|Open-label Period Population||Scores on a Scale||Standard Deviation|Mean
651986|NCT02014584|Secondary|Change From Baseline in Participant Satisfaction With Hair Growth as Assessed by the Total Score of the Hair Growth Satisfaction Scale (HGSS) in the Double-blind Treatment Period|The HGSS assessed participants satisfaction with hair appearance and growth by scoring 5 questions on a 7-point scale ranging from 1=very dissatisfied to 7= very satisfied with a maximum score of 35. The Baseline assessment was defined as the latest assessment on or before the DB treatment start. Change from Baseline is post-Baseline value minus Baseline value. A decrease from Baseline indicates a worsening. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 12 and Week 24|Safety Population||Scores on a Scale||Standard Error|Least Squares Mean
651987|NCT02014584|Secondary|Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Open-label Treatment Period|The IIEF is a validated 15-item questionnaire with individual items of the questionnaire assigned to five separate domains of sexual function (i.e., erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction). The IIEF was employed to assess treatment-related changes in men with erectile dysfunction. Overall score range is 0-75. The erectile function score range is 0-30, intercourse satisfaction score range is 0-15, orgasmic function score range is 0-10, sexual desire score range is 0-10, overall satisfaction score range is 0-10. A decrease from Baseline indicates a worsening. The Baseline assessment was defined as the latest assessment on or before the OL treatment start. Change from Baseline is post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 4, Week 12 and Week 24|Open-label Period Population||Scores on a Scale||Standard Deviation|Mean
651988|NCT02014584|Secondary|Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Double-blind Treatment Period|The IIEF is a validated 15-item questionnaire with individual items of the questionnaire assigned to five separate domains of sexual function (i.e., erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction). The IIEF was employed to assess treatment-related changes in men with erectile dysfunction. Overall score range is 0-75. The erectile function score range is 0-30, intercourse satisfaction score range is 0-15, orgasmic function score range is 0-10, sexual desire score range is 0-10, overall satisfaction score range is 0-10. A decrease from Baseline indicates a worsening. The Baseline assessment was defined as the latest assessment on or before the DB treatment start. Change from Baseline is post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 4, Week 12 and Week 24|Safety Population||Scores on a Scale||Standard Error|Least Squares Mean
651989|NCT02014584|Secondary|Change From Baseline in Total Score of the IIEF in the Open-label Treatment Period|The IIEF is a validated 15-item questionnaire with individual items of the questionnaire assigned to five separate domains of sexual function (i.e., erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction). The IIEF was employed to assess treatment-related changes in men with erectile dysfunction. Overall score range is 0-75. The erectile function score range is 0-30, intercourse satisfaction score range is 0-15, orgasmic function score range is 0-10, sexual desire score range is 0-10, overall satisfaction score range is 0-10. A decrease from Baseline indicates a worsening. The change from Baseline values are presented for Week 4, Week 12 and Week 24. The Baseline assessment was defined as the latest assessment on or before the DB treatment start. Change from Baseline is post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 4, Week 12 and Week 24|Open-Label Period Population||Scores on a Scale||Standard Deviation|Mean
651990|NCT02014584|Secondary|Change From Baseline in Total Score of the IIEF in the Double-blind Treatment Period|The IIEF is a validated 15-item questionnaire with individual items of the questionnaire assigned to five separate domains of sexual function (i.e., erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction). The IIEF was employed to assess treatment-related changes in men with erectile dysfunction. Overall score range is 0-75. The erectile function score range is 0-30, intercourse satisfaction score range is 0-15, orgasmic function score range is 0-10, sexual desire score range is 0-10, overall satisfaction score range is 0-10. A decrease from Baseline indicates a worsening. The change from Baseline values are presented for Week 4, Week 12 and Week 24. The Baseline assessment was defined as the latest assessment on or before the DB treatment start. Change from Baseline is post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 4, Week 12 and Week 24|Safety Population||Scores on a Scale||Standard Error|Least Squares Mean
652348|NCT02009865|Secondary|Percent Change in Triglycerides for Subjects With at Least 1 Qualifying Triglyceride >885 mg/dL|This first secondary endpoint in subjects with at least 1 qualifying triglyceride >885 mg/dL was tested in parallel together with the primary endpoint, each at 0.025 Type I error rate.|From Baseline to Week 12 Endpoint|FAS||Percentage of change (%)||Inter-Quartile Range|Median
651991|NCT02014584|Secondary|Number of Participants With a Change in Sexual Function Defined as a Negative Change From Baseline in the IIEF Erectile Function Domain (IIEF-EF) Score of >=4 Units in the Open-label Treatment Period|The IIEF is a validated 15-item questionnaire with individual items of the questionnaire assigned to five separate domains of sexual function (i.e., erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction). The IIEF was employed to assess treatment-related changes in men with erectile dysfunction. The erectile function domain of the IIEF (IIEF-EF) includes Questions 1 through 5 and Question 15 (maximum score of 30). A clinically meaningful gradient of severity of erectile dysfunction (ED) has been developed, indicating that a score of greater than 25 represents an individual without ED while men scoring <=25 may be classified as having ED. The values are presented for Week 4, Week 12 and Week 24. The Baseline assessment was defined as the latest assessment on or before the DB treatment start. Change from Baseline is post-Baseline value minus Baseline value.|Baseline, Week 4, Week 12 and Week 24|Open-Label Period Population||Participants|||Number
651992|NCT02014584|Secondary|Number of Participants With a Change in Sexual Function Defined as a Negative Change From Baseline in the International Index of Erectile Function (IIEF) Erectile Function Domain (IIEF-EF) Score of >=4 Units in the Double-blind Treatment Period|The IIEF is a validated 15-item questionnaire with individual items of the questionnaire assigned to five separate domains of sexual function (i.e., erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction). The IIEF was employed to assess treatment-related changes in men with erectile dysfunction. The erectile function domain of the IIEF (IIEF-EF) includes Questions 1 through 5 and Question 15 (maximum score of 30). A clinically meaningful gradient of severity of erectile dysfunction (ED) has been developed, indicating that a score of greater than 25 represents an individual without ED while men scoring <=25 may be classified as having ED. The values are presented for Week 4, Week 12 and Week 24. The Baseline assessment was defined as the latest assessment on or before the DB treatment start. Change from Baseline is post-Baseline value minus Baseline value.|Baseline, Week 4, Week 12 and Week 24|Safety Population||Participants|||Number
651993|NCT02014584|Secondary|Incidence of Premature Discontinuations in the Open-label Treatment Period|Participants were referred as premature discontinuations if they do not complete the open-label treatment period. The reasons for premature withdrawal were protocol deviation, lost to follow-up and withdrawal of consent by participants.|Week 48|ITT population||Participants|||Number
651994|NCT02014584|Secondary|Incidence of Premature Discontinuations in the Double-blind Treatment Period|Participants were referred as premature discontinuations if they do not complete the double-blind period. The reasons for premature withdrawal were protocol deviation, lost to follow-up and withdrawal of consent by participants.|Week 24|ITT population||Participants|||Number
651995|NCT02014584|Secondary|Change From Baseline in the Indicated Clinical Chemistry Parameters in the Open-label Treatment Period: Glucose, Potassium, Sodium and Urea/BUN.|Clinical chemistry parameters included: glucose, potassium, sodium, and urea/BUN at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 24|Open-Label Period Population||MMOL/L||Standard Deviation|Mean
651996|NCT02014584|Secondary|Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period: Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN)|Clinical chemistry parameters included: glucose, potassium, sodium, and urea/BUN at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the double-blind treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 24|Safety Population||MMOL/L||Standard Deviation|Mean
651997|NCT02014584|Secondary|Change From Baseline in the Clinical Chemistry Parameters in the Open-label Treatment Period: Creatinine, Direct Bilirubin and Total Bilirubin.|Clinical chemistry parameters included: creatinine, direct bilirubin, total bilirubin at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 24|Open-Label Period Population||UMOL/L||Standard Deviation|Mean
651998|NCT02014584|Secondary|Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period: Creatinine, Direct Bilirubin and Total Bilirubin|Clinical chemistry parameters included: creatinine, direct bilirubin, total bilirubin at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the double-blind treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 24|Safety Population||UMOL/L||Standard Deviation|Mean
651999|NCT02014584|Secondary|Change From Baseline in the Indicated Clinical Chemistry Parameters in the Open-label Treatment Period|Clinical chemistry parameters included: ALT, ALP, AST, and GGT at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 24|Open-Label Period Population||IU/L||Standard Deviation|Mean
652349|NCT02009865|Primary|Percent Change in Triglyceride for All Subjects|This primary endpoint was tested in parallel together with the first of the secondary endpoints, each at 0.025 Type I error rate.|From Baseline to Week 12 Endpoint|Full Analysis Set (FAS)||Percentage of change (%)||Inter-Quartile Range|Median
652835|NCT01998399|Secondary|Hospital Free Days|Number of days the patient is not in the hospital|60 days||||||
652000|NCT02014584|Secondary|Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period|Clinical chemistry parameters included: alanine aminotransferase (ALT), alkaline phosphatase (ALP), aspartate aminotransferase (AST) and gamma glutamyl transferase (GGT) at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the double-blind treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 24|Safety Population||IU/L||Standard Deviation|Mean
652001|NCT02014584|Secondary|Change From Baseline in Clinical Chemistry Parameters in the Open-label Treatment Period: Albumin and Total Protein|Clinical chemistry parameters included: albumin and total protein at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 24|Open-Label Period Population||G/L||Standard Deviation|Mean
652002|NCT02014584|Secondary|Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period: Albumin and Total Protein|Clinical chemistry parameters included: albumin and total protein at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 24|Safety Population||G/L||Standard Deviation|Mean
652003|NCT02014584|Secondary|Change From Baseline in the Indicated Hematology Parameter in the Open-label Treatment Period: Red Blood Cell (RBC) Count|Hematology parameter included: RBC at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 24|Open-Label Period Population||T/L||Standard Deviation|Mean
652004|NCT02014584|Secondary|Change From Baseline in the Indicated Hematology Parameter in the Double-blind Treatment Period: Red Blood Cell (RBC) Count|Hematology parameter included: RBC at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the double-blind treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 24|Safety Population||T/L||Standard Deviation|Mean
652005|NCT02014584|Secondary|Change From Baseline in the Indicated Hematology Parameter in the Open-label Treatment Period: Hemoglobin|Hematology parameters included: hemoglobin at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 24|Open-Label Period Population||G/L||Standard Deviation|Mean
652006|NCT02014584|Secondary|Change From Baseline in the Indicated Hematology Parameter in the Double-blind Treatment Period: Hemoglobin|Hematology parameter included: hemoglobin at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the double-blind treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 24|Safety Population||G/L||Standard Deviation|Mean
652007|NCT02014584|Secondary|Change From Baseline in the Indicated Hematology Parameter in the Open-label Treatment Period: Hematocrit|Hematology parameter included: hematocrit at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 24|Open-Label Period Population||Proportion of RBCs||Standard Deviation|Mean
652008|NCT02014584|Secondary|Change From Baseline in the Indicated Hematology Parameter in the Double-blind Treatment Period: Hematocrit|Hematology parameter included: hematocrit at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the double-blind treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 24|Safety Population||Proportion of RBCs||Standard Deviation|Mean
652009|NCT02014584|Secondary|Change From Baseline in the Indicated Hematology Parameters in the Open-label Treatment Period|Hematology parameters included: platelet count, white blood cell (WBC) count, basophils, eosinophils, lymphocytes, monocytes, segmented neutrophils, and total neutrophils at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 24|Open-Label Period Population||Giga per Liter (GI/L)||Standard Deviation|Mean
652836|NCT01998399|Secondary|In-hospital Mortality|Did the patient die during the hospitalization?|Throughout hospitalization||||||
652837|NCT01998399|Secondary|Ventilator Free Days||28 days||||||
652010|NCT02014584|Secondary|Change From Baseline in the Indicated Hematology Parameters in the Double-blind Treatment Period|Hematology parameters included: platelet count, white blood cell (WBC) count, basophils, eosinophils, lymphocytes, monocytes, segmented neutrophils and total neutrophils at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the double-blind treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 24|Safety Population||Giga per Liter (GI/L)||Standard Deviation|Mean
652011|NCT02014584|Secondary|Number of Participants With Frequency of Heart Rate of Clinical Concern in the Open-label Treatment Period|Baseline heart rate assessment was defined as the latest assessment on or before the open-label treatment start. The clinical concern range for heart rate was defined as: (lower: <40, upper: >100).|Baseline and up to Week 24|Open-Label Period Population||Participants|||Number
652012|NCT02014584|Secondary|Number of Participants With Frequency of Heart Rate of Clinical Concern in the Double-blind Treatment Period|The Baseline heart rate assessment was defined as the latest assessment on or before the double-blind treatment start. The clinical concern range for heart rate was defined as: (lower: <40, upper: >100).|Baseline and up to Week 24|Safety Population||Participants|||Number
652013|NCT02014584|Secondary|Number of Participants With Frequency of Systolic and Diastolic Blood Pressure of Clinical Concern in the Open-label Treatment Period|The Baseline blood presssure assessment was defined as the latest assessment on or before the open-label treatment start. The clinical concern range for vital signs was defined as: systolic blood pressure (lower: <80, upper: >165) and diastolic blood pressure: (lower: <40, upper: >105).|Baseline and up to Week 24|Open-Label Period Population||Participants|||Number
652014|NCT02014584|Secondary|Number of Participants With Frequency of Systolic and Diastolic Blood Pressure of Clinical Concern in the Double-blind Treatment Period|The Baseline blood presssure assessment was defined as the latest assessment on or before the double-blind treatment start. The clinical concern range for vital signs was defined as: Systolic blood pressure (lower: <80, upper: >165) and diastolic blood pressure: (lower: <40, upper: >105).|Baseline and up to Week 24|Safety Population||Participants|||Number
652015|NCT02014584|Secondary|Change From Baseline in Heart Rate in the Open-label Treatment Period|Baseline heart rate assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 12 and Week 24|Open-Label Period Population||Beats per Minute||Standard Deviation|Mean
652016|NCT02014584|Secondary|Change From Baseline in Heart Rate in the Double-blind Treatment Period|The Baseline heart rate assessment was defined as the latest assessment on or before the double-blind treatment start. Change from Baseline is post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 12 and Week 24|Safety Population||Beats per Minute||Standard Deviation|Mean
652017|NCT02014584|Secondary|Change From Baseline in Systolic and Diastolic Blood Pressure in the Open-label Treatment Period|Baseline blood presure assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 12 and Week 24|Open-Label Period Population||mmHg||Standard Deviation|Mean
652018|NCT02014584|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in the Double-blind Treatment Period|The Baseline blood presssure assessment was defined as the latest assessment on or before the double-blind treatment start. Change from Baseline is post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 12 and Week 24|Safety Population||millimeter of mercury (mmHg)||Standard Deviation|Mean
652019|NCT02014584|Secondary|Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Open-label Treatment Period|Assessment of suicidality were done through use of the Columbia Suicide Severity Rating Scale (C-SSRS) for suicidal ideation with the ratings 1 to 5 (1. wish to be dead, 2. Non-specific suicidal thoughts, 3. without intent, 4. with intent but no plan, 5. with plan and intent) and for suicidal behavior with the ratings 6 to 9 (6.Prep acts/behavior, 7.aborted attempt, 8. interrupted attempt and 9. actual attempt). C-SSRS was administered at Day 1, Week 12, Week 24, and the early withdrawal visit if applicable .|24 weeks|Safety Population||Participants|||Number
652020|NCT02014584|Secondary|Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Double-blind Treatment Period|Assessment of suicidality were done through use of the Columbia Suicide Severity Rating Scale (C-SSRS) for suicidal ideation with the ratings 1 to 5 (1. wish to be dead, 2. Non-specific suicidal thoughts, 3..without intent, 4. with intent but no plan, 5. with plan and intent) and for suicidal behavior with the ratings 6 to 9 (6.Prep acts/behavior, 7.aborted attempt, 8. interrupted attempt and 9. actual attempt). C-SSRS was administered at Day 1, Week 12, Week 24, and the early withdrawal visit if applicable .|24 weeks|Safety Population||Participants|||Number
652021|NCT02014584|Secondary|Number of Participants With AEs of Special Interest in the Double-blind and Open-label Combined Periods|An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs of special interest included those of sexual function: breast disorders (breast enlargement and breast tenderness), prostate cancer, cardiovascular events, and possible suicidality-related AEs (PSRAEs). Infrequent AEs of special interest included breast cancer, allergic reactions, depressed mood, hair changes, interference with formation of external genitalia in a male fetus, potential for decreased male fertility, and testicular pain and swelling. Special interest AEs are groups of MedDRA terms which have been defined in the analysis plan.|48 weeks|Dutasteride DB/OL Combined population||Participants|||Number
652350|NCT02009722|Secondary|Treatment for Pruritus|The number of patients needing medical treatment for pruritus in first 24 hours after surgery|First 24 hours after spinal|only patients receiving most commonly used doses of IT hydromorphone (50,75,100 mcg) and morphine (100,150 mcg)||participants|||Number
652838|NCT01998399|Secondary|Shock Free Days|Not requiring pressor support for hypotension|14 days||||||
652022|NCT02014584|Secondary|Number of Participants With AEs of Special Interest in the Open-label Treatment Period|An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs of special interest included those of sexual function: breast disorders (breast enlargement and breast tenderness), prostate cancer, cardiovascular events, and possible suicidality-related AEs (PSRAEs). Infrequent AEs of special interest included breast cancer, allergic reactions, depressed mood, hair changes, interference with formation of external genitalia in a male fetus, potential for decreased male fertility, and testicular pain and swelling. Special interest AEs are groups of MedDRA terms which have been defined in the analysis plan.|24 weeks|Open-Label Period Population||Participants|||Number
652023|NCT02014584|Secondary|Number of Participants With AEs of Special Interest in the Double-blind Treatment Period|An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs of special interest included those of sexual function: breast disorders (breast enlargement and breast tenderness), prostate cancer, cardiovascular events, and possible suicidality-related AEs (PSRAEs). Infrequent AEs of special interest included breast cancer, allergic reactions, depressed mood, hair changes, interference with formation of external genitalia in a male fetus, potential for decreased male fertility, and testicular pain and swelling. Special interest AEs are groups of MedDRA terms which have been defined in the analysis plan.|24 weeks|Safety Population||Participants|||Number
652024|NCT02014584|Secondary|Number of Participants With Treatment-related AEs in the Double-blind and Open-label Combined Periods|An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment related AE included events which the investigator classified as having a reasonable possibility of being caused by the investigational product or whose classification was missing.|48 weeks|Dutasteride DB/OL Combined population||Participants|||Number
652025|NCT02014584|Secondary|Number of Participants With Treatment-related AEs in the Open-label Treatment Period|An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment related AE included events which the investigator classified as having a reasonable possibilty of being caused by the investigational product or whose classification was missing.|24 weeks|Open-Label Period Population||Participants|||Number
652026|NCT02014584|Secondary|Number of Participants With Treatment-related AEs in the Double-blind Treatment Period|An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment related AE included events which the investigator classified as having a reasonable possibilty of being caused by the investigational product or whose classification was missing.|24 weeks|Safety Population||Participants|||Number
652027|NCT02014584|Secondary|Number of Participants With AEs, SAEs and PSRAEs in the Double-blind and Open-label Combined Periods|An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.. SAE is defined as any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment, all events of possible drug-induced liver injury with hyperbilirubinemia, breast cancer in male participants, or spontaneous abortion in female partner of male participant. The PSRAE form was used in this study to collect detailed information on the circumstances of reported AEs which, in the investigator's opinion, were possibly suicidality-related.|48 weeks|Dutasteride DB/OL Combined population||Participants|||Number
652028|NCT02014584|Secondary|Number of Participants With AEs, SAEs and PSRAEs in the Open-label Treatment Period|An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.. SAE is defined as any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment, all events of possible drug-induced liver injury with hyperbilirubinemia, breast cancer in male participants, or spontaneous abortion in female partner of male participant. The PSRAE form was used in this study to collect detailed information on the circumstances of reported AEs which, in the investigator's opinion, were possibly suicidality-related.|24 weeks|Open-Label Period Population||Participants|||Number
652029|NCT02014584|Secondary|Number of Participants With AEs, Serious AEs (SAEs) and Possible Suicidality Related Adverse Events (PSRAEs) in the Double-blind Treatment Period|An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment, all events of possible drug-induced liver injury with hyperbilirubinemia, breast cancer in male participants, or spontaneous abortion in female partner of male participant. The PSRAE form was used in this study to collect detailed information on the circumstances of reported AEs which, in the investigator's opinion, were possibly suicidality-related.|24 weeks|Safety Population||Participants|||Number
652030|NCT02014584|Secondary|Number of Participants Who Discontinued Study Treatment Due to AEs Related to Sexual Function in the Double-blind and Open-label Combined Periods|An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders.|48 weeks|Dutasteride DB/OL Combined population||Participants|||Number
652351|NCT02009722|Secondary|Treatment for Nausea|number of patients needing medication treatment for nausea in first 24 hours|First 24 hours|patients receiving most commonly used doses of IT medication (50,75,100 mcg for hydromorphone; 100, 150 mcg for morphine)||participants|||Number
652033|NCT02014584|Secondary|Duration and Persistence of AEs Related to Sexual Function in the Double-blind and Open-label Combined Periods|An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders. Duration is the total number of non-overlapping days for all events per subject. A duration is censored if there is at least one event with unknown start date or end date, in which case the censored duration is the minimum number of days that a subject has experienced any of these events. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). NA=not applicable.|48 weeks|Dutasteride DB/OL Combined population||Days||Standard Deviation|Mean
652034|NCT02014584|Secondary|Duration and Persistence of AEs Related to Sexual Function in the Open-label Treatment Period|An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders. Duration is the total number of non-overlapping days for all events per subject. A duration is censored if there is at least one event with unknown start date or end date, in which case the censored duration is the minimum number of days that a subject has experienced any of these events. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). NA=not applicable.|24 weeks|Safety Population||Days||Standard Deviation|Mean
652035|NCT02014584|Secondary|Duration and Persistence of AEs Related to Sexual Function in the Double-blind Treatment Period|An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders. Duration is the total number of non-overlapping days for all events per subject. A duration is censored if there is at least one event with unknown start date or end date, in which case the censored duration is the minimum number of days that a subject has experienced any of these events. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). NA=not applicable.|24 weeks|Safety Population||Days||Standard Deviation|Mean
652036|NCT02014584|Primary|Number of Participants With AE Related to Sexual Function for the Double-blind and Open-label Combined Periods|An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders.|48 weeks|Dutasteride DB/OL Combined: all participants who entered the OL Period and taken Dutasteride in both the DB and the OL periods.||Participants|||Number
652037|NCT02014584|Primary|Number of Participants With AE Related to Sexual Function in the Open-label Treatment Period|An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders.|24 weeks|Open-Label Period Population: all participants who entered the open-label period.||Participants|||Number
652038|NCT02014584|Primary|Number of Participants With Adverse Events (AE) Related to Sexual Function in the Double-blind Treatment Period|An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders.|24 weeks|Safety Population: all randomized participants who received at least one dose of study treatment.||Participants|||Number
652039|NCT02014480|Secondary|Change From Baseline in Clinic Visit Pre-dose Trough FEV1 at Day 15 of Each Treatment Period|Trough FEV1 on Treatment Day 15 is defined as the mean of the FEV1 values obtained at 23 and 24 hours after dosing on Day 14. Analysis was performed using an ANCOVA model with covariates of treatment, period, mean Baseline (BL), period BL, response type, and treatment by response type interaction. A participant is a reponder to UMEC if they were a responder to UMEC monotherapy or a responder to both UMEC monotherapy and VI monotherapy. A participant is a responder to VI if they were a responder to VI monotherapy or a responder to both UMEC monotherapy or VI monotherapy. BL is the mean FEV1 recorded 30 min and 5 min pre-dose on Day 1 of each treatment period, mean BL is the mean of the BLs for each participant, and period BL is the difference between BL and the mean BL in each treatment period for each participant. Change from BL for each treatment period is the Day 15 value minus the BL value for that treatment period.|Baseline and Day 15 of each treatment period (up to study day 81)|ITT Population. Only those participants available at the specified time points were analyzed. Different participants may have been analyzed for different parameters; the overall number of participants analyzed reflects everyone in the ITT Population.||Liters||Standard Error|Least Squares Mean
652040|NCT02014480|Secondary|Number of Participants With a Larger Change From Baseline in 0-6 Hour Weighted Mean FEV1 at Day 14 of Each Treatment Period With UMEC/VI Compared With UMEC and VI Alone|The number of participants with a larger change from Baseline in weighted mean FEV1 with UMEC/VI compared with UMEC and VI alone was recorded. Participants who improved on UMEC/VI had a larger change from Baseline difference in 0-6 hour weighted mean FEV1 on Day 14 on UMEC/VI compared to UMEC or VI alone. Baseline is the mean FEV1 values recorded 30 min and 5 min pre-dose on Day 1 of each treatment period, mean Baseline is the mean of the Baselines for each participant, and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Change from Baseline for each treatment period is the Day 14 value minus the Baseline value for that treatment period.|Baseline and Day 14 of each treatment period (up to study day 85)|ITT Population. Only those participants available at the indicated time point were assessed.||participants|||Number
652125|NCT02013830|Secondary|Time to Disease Progression - Percentage of Participants Progression-free at 12 Months|Time to progression was measured from time of treatment commencement to time of disease progression, or the date of death. Participants who were not progressed at the time of study completion (including participants who died before progressive disease) or who were lost to follow-up were censored at the date of last tumor assessment.|Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.|ITT population.||percentage of participants||95% Confidence Interval|Number
652041|NCT02014480|Secondary|Number of Participants (Par.) Who Were Responsive to UMEC/VI, UMEC or, VI According to FEV1 at Day 1 of Each Treatment Period (TP)|A responder is a par. with an increase from BL of >=12% and 200 milliliters (mL) at >=1 time point over 0-6 hours post-dose (PD) in FEV1 on Day 1. A non-responder (NR) is a par. with >=1 FEV1 assessment over 0-6 hours PD on Day 1 but no increase from BL of >=12% and 200 mL at any assessment(s). Missing: no FEV1 data recorded over 0-6 hours PD on Day 1. Response type is defined based on a par.’s response to each individual monotherapy treatment. A responder to UMEC is a par. who is a responder in the UMEC treatment period (TP) and either a NR or has missing data in the VI TP. A responder to VI is a par. who is a responder in the VI TP and either a NR or has missing data in the UMEC TP. A responder to UMEC and VI is a par. who is a responder in both the UMEC and VI TPs. A responder to neither is a par. who is a NR in both the UMEC and VI TPs. Missing: a par. who has missing data in both the UMEC and VI TPs, or who has missing data in one monotherapy period and is a NR in the other.|Baseline (BL) and 0-6 hours post-dose (15 minutes, 30 minutes, and 1, 3, and 6 hours post-dose) on Day 1 of each treatment period (up to study day 66)|ITT Population||participants|||Number
652042|NCT02014480|Primary|Change From Baseline (BL) in Weighted Mean (WM) 0-6 Hour Forced Expiratory Volume in One Second (FEV1) Obtained Post-dose at Day 14 of Each Treatment Period (TP) by Response Type|FEV1 is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. The WM FEV1 was derived by calculating the area under the FEV1/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. The WM FEV1 was calculated using 0-6 hour post-dose measurements at Day 14 of each TP, which included pre-dose (trough value for Day 14 [mean of the 23 and 24 hour assessments post Day 13 dosing]) and post-dose 15 minutes (min), 30 min, and 1, 3, and 6 hours. BL is the mean FEV1 values recorded 30 min and 5 min pre-dose on Day 1 of each TP, mean BL is the mean of the BLs for each participant, and period BL is the difference between the BL and the mean BL in each TP for each participant. Change from BL for each TP is the Day 14 value minus the BL value for that TP.|Baseline and Day 14 of each treatment period (up to study day 85)|Intent-to-Treat (ITT) Population: all participants (par.) randomized to treatment who received >=1 dose of randomized study medication in a TP. Only par. available at the specified time points were analyzed. Different par. may have been analyzed for different parameters; the overall number of par, analyzed reflects everyone in the ITT Population.||Liters||Standard Error|Least Squares Mean
652043|NCT02014467|Secondary|Number of Participants With Any Adverse Events (AEs), Serious Adverse Events (Non-fatal Serious Adverse Events and Fatal Serious Adverse Events)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or other events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcome listed above, liver injury and impaired liver function and grade 4 laboratory abnormalities. Number of participants with any AEs, serious non-fatal AEs, serious fatal AEs have been presented.|From start of IP through the Study Phase (6 months post-dose) (assessed up to 12 months)|Safety Population. Two participants randomized to placebo group received denosumab by mistake.||Participants|||Number
652044|NCT02014467|Secondary|Number of Participants With Confirmed Anti-denosumab Antibody Formation at Baseline and Month 12|Anti-denosumab antibody formation was assessed at Baseline (Visit 3) and Month 12. Binding antibody and neutralizing antibody assays were used to assess number of participants with anti-denosumab antibody.|Baseline and Month 12|Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).||Participants|||Number
652045|NCT02014467|Secondary|Change From Baseline in Red Blood Cell Count at Month 6 and Month 12|Baseline value was obtained at screening (visit 2). If missing, the most recent non-missing value was used. Change in baseline value was assessed as: Value at Indicated visit minus Baseline value. Blood samples were collected for measurement. Red blood cell count was assessed at Baseline, Month 6 and Month 12.|Baseline, Month 6 and Month 12|Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).||Trillion cells per liter (TI/L)||Standard Deviation|Mean
652046|NCT02014467|Secondary|Change From Baseline in Mean Corpuscle Volume at Month 6 and Month 12.|Baseline value was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in baseline value was assessed as the value at the indicated visit minus the Baseline value. Blood samples were collected for measurement. Mean corpuscle volume was assessed at Baseline, Month 6 and Month 12.|Baseline, Month 6 and Month 12|Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).||Femtoliter (FL)||Standard Deviation|Mean
652047|NCT02014467|Secondary|Change From Baseline in Mean Corpuscle Hemoglobin at Month 6 and Month 12.|Baseline value was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Blood samples were collected for measurement. Mean corpuscle hemoglobin was assessed at Baseline, Month 6 and Month 12.|Baseline, Month 6 and Month 12.|Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).||Picograms (PG)||Standard Deviation|Mean
652048|NCT02014467|Secondary|Change From Baseline in Hematocrit at Month 6 and Month 12.|Baseline value was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Blood samples were collected for measurement. Hematocrit was assessed at Baseline, Month 6 and Month 12.|Baseline, Month 6 and Month 12.|Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).||Ratio||Standard Deviation|Mean
652839|NCT01998399|Primary|All-cause Mortality|Alive or dead on day 90|90 day|number of patients that completed the study was too low for a valid statistical analysis||participants|||Number
652049|NCT02014467|Secondary|Change From Baseline in Creatinine and Uric Acid at Month 6 and Month 12|Baseline value was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Blood samples were collected for measurement. Creatinine and uric acid were assessed at Baseline, Month 6 and Month 12.|Baseline, Month 6 and Month 12|Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).||Micromoles per liter (UMOL/L)||Standard Deviation|Mean
652050|NCT02014467|Secondary|Change From Baseline in Direct Bilirubin, Total Bilirubin at Month 1, Month 6 and Month 12.|Baseline value was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Blood samples were collected for measurement. Direct bilirubin and total bilirubin were assessed at Baseline, Month 1, Month 6 and Month 12.|Baseline, Month 1, Month 6 and Month 12|Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).||Micromoles per liter (UMOL/L)||Standard Deviation|Mean
652051|NCT02014467|Secondary|Change From Baseline in Chloride, Cholesterol, Glucose, Magnesium, Inorganic Phosphorous, Potassium, Sodium, Triglycerides, Urea/Blood Urea Nitrogen (BUN) at Month 6 and Month 12.|Baseline value was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Blood samples were collected for measurement. Chloride, cholesterol, glucose, magnesium, inorganic phosphorous, potassium, sodium, triglycerides and urea/BUN were assessed at Baseline, Month 6 and Month 12.|Baseline, Month 6 and Month 12|Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).||Millimoles per liter (mmol/L)||Standard Deviation|Mean
652052|NCT02014467|Secondary|Change From Baseline in Calcium (Corrected), Calcium at Month 1, Month 6 and Month 12.|Baseline value was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Blood samples were collected for measurement. Calcium (corrected) and calcium were assessed at Baseline, Month 1, Month 6 and Month 12.|Baseline, Month 1, Month 6 and Month 12.|Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).||Millimoles per liter (mmol/L)||Standard Deviation|Mean
652053|NCT02014467|Secondary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils-total Absolute Neutrophil Count (ANC), White Blood Cell Count at Month 6 and Month 12.|Baseline value was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Blood samples were collected for measurement. Basophils, eosinophils, lymphocytes, monocytes, platelet count, total neutrophils-total ANC and white blood cell count were assessed at Baseline, Month 6 and Month 12.|Baseline, Month 6 and Month 12|Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).||Giga per liter (GI/L)||Standard Deviation|Mean
652054|NCT02014467|Secondary|Change From Baseline in Hemoglobin and Total Protein at Month 6 and Month 12.|Baseline value was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at indicated visit minus the Baseline value. Blood samples were collected for measurement. Hemoglobin and total protein were assessed at Baseline, Month 6 and Month 12.|Baseline, Month 6 and Month 12|Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).||Grams per liter (G/L)||Standard Deviation|Mean
652055|NCT02014467|Secondary|Change From Baseline in Globulin at Month 6 and Month 12.|Baseline value was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at indicated visit minus the Baseline value. Blood samples were collected for measurement. Globulin was assessed at Baseline, Month 6 and Month 12.|Baseline, Month 6 and Month 12|Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).||Grams per liter (G/L)||Standard Deviation|Mean
652056|NCT02014467|Secondary|Change From Baseline in Albumin at Month 1, Month 6 and Month 12.|Baseline value was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Blood samples were collected for measurement. Albumin was assessed at Baseline, Month 1, Month 6 and Month 12.|Baseline, Month 1, Month 6 and Month 12.|Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).||Gram per liter (G/L)||Standard Deviation|Mean
652057|NCT02014467|Secondary|Change From Baseline in Creatine Kinase, Lactate Dehydrogenase at Month 6 and Month 12.|Baseline values was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Blood samples were collected for measurement. Creatine kinase and lactate dehydrogenase were assessed at Baseline, Month 6 and Month 12.|Baseline, Month 6 and Month 12|Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).||International unit per liter (IU/L)||Standard Deviation|Mean
652082|NCT02014441|Secondary|Percentage of Samples From the Anogenital Area With Detectable Talimogene Laherparepvec DNA After the End of Treatment|Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of swab samples from the anogenital area with detectable talimogene laherparepvec DNA after the end of treatment is reported.|30 to 60 days after the last dose of talimogene laherparepvec.|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab from the anogenital area collected after end of treatment.||percentage of samples|samples||Number
652058|NCT02014467|Secondary|Change From Baseline in Alanine Amino Transferase, Alkaline Phosphatase, Aspartate Amino Transferase, and Gamma Glutamyl Transferase at Month 1, Month 6 and Month 12|Baseline values were obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Blood samples were collected for measurement. Alanine amino transferase, alkaline phosphatase, aspartate amino transferase, and gamma glutamyl transferase were assessed at Baseline, Month 1, Month 6 and Month 12.|Baseline, Month 1, Month 6, and Month 12|Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).||International unit per liter (IU/L)||Standard Deviation|Mean
652059|NCT02014467|Secondary|Change From Baseline in Heart Rate at Month 1, Month 3, Month 6, and Month 12|Baseline value was obtained at Randomization (Visit 3). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Change from Baseline in heart rate was assessed at Baseline, Month 1, Month 3, Month 6 and Month 12.|Baseline, Month 1, Month 3, Month 6 and Month 12|Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).||Beats per minute||Standard Deviation|Mean
652060|NCT02014467|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Month 1, Month 3, Month 6, and Month 12|Baseline value was obtained at Randomization (Visit 3). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Change from Baseline in SBP and DBP was assessed at Baseline, Month 1, Month 3, Month 6, and Month 12.|Baseline, Month 1, Month 3, Month 6 and Month 12|Safety Population: all participants who received at least one dose of study medication. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).||Millimeters of mercury (mmHg)||Standard Deviation|Mean
652061|NCT02014467|Secondary|Percent Change in Serum Procollagen Type I N Propeptideserum (s-PINP) From Baseline to Month 6 and Month 12|s-PINP is biomarker of bone resorption and formation. s-PINP was assessed during Screening, Month 6 and Month 12 in the Double-blind Treatment Phase. The value during Screening was considered as the Baseline value. Percent change from Baseline was assessed as the value at the indicated visit minus the Baseline value divided by the Baseline value x 100. A two-sided Wilcoxon rank sum test was used to compare percent change in serum CTX. Between group inferences is presented by p-values, Hodges-Lehmann estimates along with 95% confidence intervals.|Baseline, Month 6, Month 12|ITT Population: Only those participants with values at Baseline and Month 6 and Month 12 are included in the analysis (represented by n=X, X in the category titles).||Percentage change||Inter-Quartile Range|Median
652062|NCT02014467|Secondary|Percent Change in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (s-CTX) From Baseline to Month 6 and Month 12|s-CTX is biomarker of bone resorption and formation. s-CTX was assessed during Screening, Month 6 and Month 12 in the Double-blind Treatment Phase. The value during Screening was considered as the Baseline value. Percent change from Baseline was assessed as the value at the indicated visit minus the Baseline value divided by the Baseline value x 100. A two-sided Wilcoxon rank sum test was used to compare percent change in s-CTX. Between group inferences is presented by p-values, Hodges-Lehmann estimates along with 95% confidence intervals.|Baseline, Month 6 and Month 12|ITT Population. Only those participants with values at Baseline and Month 6 and Month 12 are included in the analysis (represented by n=X, X in the category titles).||Percentage change||Inter-Quartile Range|Median
652063|NCT02014467|Secondary|Percent Change From Baseline in BMD at the Trochanter at Month 12|BMD is the amount of bone mineral in bone tissue. BMD scan was done using DXA. It is used to identify osteoporosis, determine risk for fractures, and measure response to osteoporosis treatment. The percentage change from Baseline for BMD was calculated as the value at the indicated time point minus the Baseline value multiplied by 100 and divided by the Baseline value. ANCOVA model adjusted for treatment, center/region and Baseline BMD for the skeletal site under consideration as a continuous covariate for assessment. Region and treatment by region interaction was included in the model. Screening visit was considered as baseline for BMD. For participants who withdrew early, the missing BMD assessments was estimated by the LOCF, provided the assessment was taken on or after at least one month on-therapy.|Baseline and Month 12|ITT Population. Participants with values at Baseline and Month 12 were included in the analysis.||Percentage change||Standard Error|Least Squares Mean
652064|NCT02014467|Secondary|Percent Change From Baseline in BMD at the Femoral Neck at Month 12|BMD is the amount of bone mineral in bone tissue. BMD scan was done using DXA. It is used to identify osteoporosis, determine risk for fractures, and measure response to osteoporosis treatment. The percentage change from Baseline for BMD was calculated as the value at the indicated time point minus the Baseline value multiplied by 100 and divided by the Baseline value. ANCOVA model adjusted for treatment, center/region and Baseline BMD for the skeletal site under consideration as a continuous covariate for assessment. Region and treatment by region interaction was included in the model. Screening visit was considered as baseline for BMD. For participants who withdrew early, the missing BMD assessments was estimated by the LOCF, provided the assessment was taken on or after at least one month on-therapy.|Baseline and Month 12|ITT Population. Participants with values at Baseline and Month 12 were included in the analysis.||Percentage change||Standard Error|Least Squares Mean
652065|NCT02014467|Secondary|Percent Change From Baseline in BMD at the Total Hip at Month 12|BMD is the amount of bone mineral in bone tissue. BMD scan was done using DXA. It is used to identify osteoporosis, determine risk for fractures, and measure response to osteoporosis treatment. The percentage change from Baseline for BMD was calculated as the value at the indicated time point minus the Baseline value multiplied by 100 and divided by the Baseline value. ANCOVA model adjusted for treatment, center/region and Baseline BMD for the skeletal site under consideration as a continuous covariate for assessment. Region and treatment by region interaction was included in the model. Screening visit was considered as baseline for BMD. For participants who withdrew early, the missing BMD assessments was estimated by the LOCF, provided the assessment was taken on or after at least one month on-therapy.|Baseline and Month 12|ITT Population. Participants with values at Baseline and Month 12 were included in the analysis.||Percentage change||Standard Error|Least Squares Mean
652066|NCT02014467|Secondary|Percent Change From Baseline in BMD at the Trochanter at Month 6|BMD is the amount of bone mineral in bone tissue. BMD scan was done using DXA. It is used to identify osteoporosis, determine risk for fractures, and measure response to osteoporosis treatment. The percentage change from Baseline for BMD was calculated as the value at the indicated time point minus the Baseline value multiplied by 100 and divided by the Baseline value. ANCOVA model adjusted for treatment, center/region and Baseline BMD for the skeletal site under consideration as a continuous covariate for assessment. Region and treatment by region interaction was included in the model. Screening visit was considered as baseline for BMD. For participants who withdrew early, the missing BMD assessments was estimated by the LOCF, provided the assessment was taken on or after at least one month on-therapy.|Baseline and Month 6|ITT Population. Participants with values at Baseline and Month 6 were included in the analysis.||Percentage change||Standard Error|Least Squares Mean
652067|NCT02014467|Secondary|Percent Change From Baseline in BMD at the Femoral Neck at Month 6|BMD is the amount of bone mineral in bone tissue. BMD scan was done using DXA. It is used to identify osteoporosis, determine risk for fractures, and measure response to osteoporosis treatment. The percentage change from Baseline for BMD was calculated as the value at the indicated time point minus the Baseline value multiplied by 100 and divided by the Baseline value. ANCOVA model adjusted for treatment, center/region and Baseline BMD for the skeletal site under consideration as a continuous covariate for assessment. Region and treatment by region interaction was included in the model. Screening visit was considered as baseline for BMD. For participants who withdrew early, the missing BMD assessments was estimated by the LOCF, provided the assessment was taken on or after at least one month on-therapy.|Baseline and Month 6|ITT Population. Participants with values at Baseline and Month 6 were included in the analysis.||Percentage change||Standard Error|Least Squares Mean
652068|NCT02014467|Secondary|Percent Change From Baseline in BMD at the Total Hip at Month 6|BMD is the amount of bone mineral in bone tissue. BMD scan was done using DXA. It is used to identify osteoporosis, determine risk for fractures, and measure response to osteoporosis treatment. The percentage change from Baseline for BMD was calculated as the value at the indicated time point minus the Baseline value multiplied by 100 and divided by the Baseline value. ANCOVA model adjusted for treatment, center/region and Baseline BMD for the skeletal site under consideration as a continuous covariate for assessment. Region and treatment by region interaction was included in the model. Screening visit was considered as baseline for BMD. For participants who withdrew early, the missing BMD assessments was estimated by the LOCF, provided the assessment was taken on or after at least one month on-therapy.|Baseline and Month 6|ITT Population. Participants with values at Baseline and Month 6 were included in the analysis.||Percentage change||Standard Error|Least Squares Mean
652069|NCT02014467|Secondary|Percent Change From Baseline in BMD at the Lumbar Spine at Month 6|BMD is the amount of bone mineral in bone tissue. BMD scan was done using DXA. It is used to identify osteoporosis, determine risk for fractures, and measure response to osteoporosis treatment. The percentage change from Baseline for BMD was calculated as the value at the indicated time point minus the Baseline value multiplied by 100 and divided by the Baseline value. ANCOVA model adjusted for treatment, center/region and Baseline BMD for the skeletal site under consideration as a continuous covariate for assessment. Region and treatment by region interaction was included in the model. Screening visit was considered as baseline for BMD. For participants who withdrew early, the missing BMD assessments was estimated by the LOCF, provided the assessment was taken on or after at least one month on-therapy.|Baseline and Month 6|ITT Population. Participants with values at Baseline and Month 6 were included in the analysis.||Percentage change||Standard Error|Least Squares Mean
652070|NCT02014467|Primary|Percent Change From Baseline in Bone Mineral Density (BMD) at the Lumbar Spine at Month 12|Bone mineral density (BMD) is the amount of bone mineral in bone tissue. BMD scan was done using dual energy x-ray absorptiometry (DXA). It is used to identify osteoporosis, determine risk for fractures, and measure response to osteoporosis treatment. The percentage change from Baseline for BMD was calcuated as the value at the indicated time point minus the Baseline value multiplied by 100 and divided by the Baseline value. The analysis was performed by Analysis of Covariance (ANCOVA) model adjusted for treatment, region and Baseline BMD for the skeletal site under consideration as a continuous covariate for assessment. Region and treatment by region interaction was included in the model. Screening visit was considered as Baseline for BMD. For participants who withdrew early, the missing BMD assessments was estimated by the Last Observation Carried Forward (LOCF), provided the assessment was taken on or after at least one month on-therapy.|Baseline and Month 12|Intent-to-Treat (ITT) Population: all safety Population participants (consisting of all participants who received at least one dose of study medication) who had a Baseline and at least one valid post-Baseline efficacy measure. Participants with values at Baseline and Month 12 were included in the analysis.||Percentage change||Standard Error|Least Squares Mean
652071|NCT02014441|Secondary|Number of Participants With Adverse Events (AEs)|The Common Terminology Criteria for Adverse Events version 3.0 was used to grade severity of adverse events, based on the following general guideline: Grade 1 = Mild AE Grade 2 = Moderate AE Grade 3 = Severe AE Grade 4 = Life-threatening or disabling AE Grade 5 = Death related to AE. A serious adverse event was defined as an adverse event that meets at least 1 of the following serious criteria: • fatal • life threatening • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • congenital anomaly/birth defect • other medically important serious event Treatment-related adverse events (TRAEs) are defined as adverse events possibly caused by talimogene laherparepvec, as assessed by the investigator.|From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median treatment duration was 21.1 weeks.|All participants who received at least 1 dose of talimogene laherparepvec.||participants|||Number
652072|NCT02014441|Secondary|Overall Survival|Overall Survival (OS) was defined as the interval from first dose of talimogene laherparepvec to death from any cause; participants still alive were censored at the last known alive date.|From first dose of talimogene laherparepvec up to the data cut-off date. The median actual follow-up time was 21.0 weeks (range: 3 to 73 weeks).|All participants who received at least 1 dose of talimogene laherparepvec.||months||95% Confidence Interval|Median
652352|NCT02009722|Secondary|Nausea|Patients will be evaluated by a member of the study team at 24 hours after spinal administration. The number of patients with moderate or severe nausea will be recorded.|24 hours after spinal|The number of patients at the most commonly used doses of IT medication (50, 75, 100 mcg for hydromorphone) and (100, 150 mcg) for morphine were used in analysis||participants|||Number
652073|NCT02014441|Secondary|Durable Response Rate|"Response was assessed according to modified World Health Organization (WHO) criteria using both clinical (cutaneous, subcutaneous, or nodal tumor measurement by caliper) and radiological imaging (computed tomography, magnetic resonance imaging or ultrasound of the chest, abdomen, and pelvis and all other sites of disease). Durable response rate is defined as the percentage of participants with a complete response or partial response maintained continuously for at least 6 months (183 days).
Complete response: disappearance of all index and non-index lesions. Partial Response:≥ 50% reduction in size of all index lesions and any new measurable lesions."|Tumor response was assessed at weeks 12 and 24 and then at least every 3 months up to 6 months after end of treatment; The median actual follow-up time was 21.0 weeks (range: 3 to 73 weeks).|All participants who received at least 1 dose of talimogene laherparepvec.||percentage of participants||95% Confidence Interval|Number
652074|NCT02014441|Secondary|Duration of Response|Duration of response (DOR) was calculated only for those participants with an objective response and defined as the longest interval from an initial objective response (complete response or partial response) to disease progression per the modified WHO criteria or death, whichever occurred earlier; otherwise, DOR was censored at the last evaluable tumor assessment for participants who did not die or progress.|Tumor response was assessed at weeks 12 and 24 and then at least every 3 months up to 6 months after end of treatment; The median actual follow-up time was 21.0 weeks (range: 3 to 73 weeks).|All participants who received at least 1 dose of talimogene laherparepvec and had an objective response.||months||95% Confidence Interval|Median
652075|NCT02014441|Secondary|Time to Response|Time to response was defined as the interval from the first dose of talimogene laherparepvec to the first event of complete response or partial response per modified WHO criteria; participants who did not respond were censored at the last evaluable tumor assessment.|Tumor response was assessed at weeks 12 and 24 and then at least every 3 months up to 6 months after end of treatment; The median actual follow-up time was 21.0 weeks (range: 3 to 73 weeks).|All participants who received at least 1 dose of talimogene laherparepvec.||months||95% Confidence Interval|Median
652076|NCT02014441|Secondary|Objective Response Rate|"Response was assessed according to modified World Health Organization (WHO) criteria using both clinical (cutaneous, subcutaneous, or nodal tumor measurement by caliper) and radiological imaging (computed tomography, magnetic resonance imaging or ultrasound of the chest, abdomen, and pelvis and all other sites of disease). Objective response rate is defined as the percentage of participants with either a complete response or partial response. Subsequent confirmation was not required.
Complete response: disappearance of all index and non-index lesions. Partial Response: ≥ 50% reduction in size of all index lesions and any new measurable lesions."|Tumor response was assessed at weeks 12 and 24 and thenat least every 3 months up to 6 months after end of treatment; The median actual follow-up time was 21.0 weeks (range: 3 to 73 weeks).|All participants who received at least 1 dose of talimogene laherparepvec.||percentage of participants||95% Confidence Interval|Number
652077|NCT02014441|Secondary|Best Overall Response|"Response was assessed according to modified World Health Organization (WHO) criteria using both clinical (cutaneous, subcutaneous, or nodal tumor measurement by caliper) and radiological imaging (computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound of the chest, abdomen, and pelvis and all other sites of disease).
Complete response: disappearance of all index and non-index lesions. Partial Response: ≥ 50% reduction in size of all index lesions and any new measurable lesions.
Stable disease: Neither sufficient tumor shrinkage of index lesion to qualify for response nor sufficient tumor increase of index lesion to qualify for progressive disease, assessed a minimum interval of 77 days from the first dose of study drug.
Progressive Disease: ≥ 25% increase in size of index lesions or appearance of one or more non-index lesions."|Tumor response was assessed at weeks 12 and 24 and then at least every 3 months up to 6 months after end of treatment; median actual follow-up time was 21.0 weeks (range: 3 to 73 weeks).|All participants who received at least 1 dose of talimogene laherparepvec.||participants|||Number
652078|NCT02014441|Secondary|Number of Samples With Detectable Talimogene Laherparepvec in Lesions Suspected to be Herpetic in Origin|Any lesion such as a cold sore or vesicle thought to be herpetic in origin was evaluated by the investigator and swabbed if HSV infection was suspected. Quantitative PCR was performed on the swab sample to evaluate whether talimogene laherparepvec DNA was detectable in the sample.|From first dose until 60 days after last dose of talimogene laherparepvec; The median actual follow-up time was 21.0 weeks (range: 3 to 73 weeks).|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab sample collected from lesions suspected to be herpetic in origin during the study.||samples|samples||Number
652079|NCT02014441|Secondary|Percentage of Participants With Detectable Talimogene Laherparepvec Virus in Swabs From the Anogenital Area After the End of Treatment|If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity.|30 to 60 days after the last dose of talimogene laherparepvec.|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab from the anogenital area collected after the end of treatment with a positive qPCR result.|||||
652080|NCT02014441|Secondary|Percentage of Participants With Detectable Talimogene Laherparepvec DNA in Swabs From the Anogenital Area After the End of Treatment|Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of participants with detectable talimogene laherparepvec DNA in swabs from the anogenital area after the end of treatment is reported.|30 to 60 days after the last dose of talimogene laherparepvec.|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab from the anogenital area collected after the end of treatment.||percentage of participants|||Number
652081|NCT02014441|Secondary|Percentage of Samples From the Anogenital Area With Detectable Talimogene Laherparepvec Virus After the End of Treatment|If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity.|30 to 60 days after the last dose of talimogene laherparepvec.|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab from the anogenital area collected after the end of treatment with a positive qPCR result.|||samples||
652353|NCT02009722|Secondary|Nausea|Patients will be evaluated by a member of the study team at 12 hours after spinal administration. The number of patients with moderate or severe nausea will be recorded.|12 hours after spinal|The number of patients at the most commonly used doses of IT medication (50, 75, 100 mcg for hydromorphone) and (100, 150 mcg) for morphine were used in analysis||participants|||Number
652083|NCT02014441|Secondary|Percentage of Participants With Detectable Talimogene Laherparepvec Virus in Oral Mucosa After the End of Treatment|If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity. The percentage of participants with detectable talimogene laherparepvec virus in swabs taken from oral mucosa after the end of treatment treatment is reported.|30 to 60 days after the last dose of talimogene laherparepvec.|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one oral mucosa swab collected after the end of treatment with a positive qPCR result.|||||
652084|NCT02014441|Secondary|Percentage of Participants With Detectable Talimogene Laherparepvec DNA in Oral Mucosa After the End of Treatment|Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of participants with detectable talimogene laherparepvec DNA in swabs taken from oral mucosa after the end of treatment is reported.|30 to 60 days after the last dose of talimogene laherparepvec.|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one oral mucosa swab collected after the end of treatment.||percentage of participants|||Number
652085|NCT02014441|Secondary|Percentage of Samples From Oral Mucosa With Detectable Talimogene Laherparepvec Virus After the End of Treatment|If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity. The percentage of samples taken from oral mucosa with detectable talimogene laherparepvec virus after the end of treatment is reported.|30 to 60 days after the last dose of talimogene laherparepvec.|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one oral mucosa swab collected after the end of treatment with a positive qPCR result.|||samples||
652086|NCT02014441|Secondary|Percentage of Samples From Oral Mucosa With Detectable Talimogene Laherparepvec DNA After the End of Treatment|Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of swab samples from oral mucosa with detectable talimogene laherparepvec DNA after the end of treatment is reported.|30 to 60 days after the last dose of talimogene laherparepvec.|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one oral mucosa swab collected after the end of treatment.||percentage of samples|samples||Number
652087|NCT02014441|Secondary|Percentage of Participants With Detectable Talimogene Laherparepvec Virus in Swabs From the Anogenital Area|If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity. Results for TCID50 for swabs of the anogenital area were not available as of the data cutoff date.|Cycle 1 on days 2, 3, 8, and 15, cycle 2 on days 1 (pre-dose), 2, 3, and 8, cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab from the anogenital area collected during treatment with a positive qPCR result.|||||
652088|NCT02014441|Secondary|Percentage of Participants With Detectable Talimogene Laherparepvec DNA in Swabs From the Anogenital Area|Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of participants with detectable talimogene laherparepvec DNA in swabs from the anogenital area at any time during treatment is reported.|Cycle 1 on days 1 (pre-dose), 8, and 15, cycles 2 and 3 on days 1 (pre-dose), and 8, cycle 4 and subsequent cycles (up to 37) on day 1 (pre-dose), Cycle 25 on day 1 (pre-dose) and day 8.|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab from the anogenital area collected during treatment.||percentage of participants|||Number
652089|NCT02014441|Secondary|Percentage of Samples With Detectable Talimogene Laherparepvec Virus in Swabs From the Anogenital Area|If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity. Results for TCID50 for swabs of the anogenital area were not available as of the data cutoff date.|Cycle 1 on days 1 (pre-dose), 8, and 15, cycles 2 and 3 on days 1 (pre-dose), and 8, cycle 4 and subsequent cycles (up to 37) on day 1 (pre-dose), Cycle 25 on day 1 (pre-dose) and day 8.|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab from the anogenital area collected during treatment with a positive qPCR result.|||samples||
652090|NCT02014441|Secondary|Percentage of Samples From the Anogenital Area With Detectable Talimogene Laherparepvec DNA|Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of swab samples from the anogenital area with detectable talimogene laherparepvec DNA at any time during treatment (cycles 1 - 37) is reported.|Cycle 1 on days 1 (pre-dose), 8, and 15, cycles 2 and 3 on days 1 (pre-dose), and 8, cycle 4 and subsequent cycles (up to 37) on day 1 (pre-dose), Cycle 25 on day 1 (pre-dose) and day 8.|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab from the anogenital area collected during treatment.||percentage of samples|samples||Number
652091|NCT02014441|Secondary|Percentage of Participants With Detectable Talimogene Laherparepvec Virus in Oral Mucosa|If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity. The percentage of participants with detectable talimogene laherparepvec virus in swabs taken from oral mucosa at any time during treatment is reported.|Cycle 1 on days 2, 3, 8, and 15, cycle 2 on days 1 (pre-dose), 2, 3, and 8, cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one oral mucosa swab collected during treatment with a positive qPCR result.||percentage of participants|||Number
652092|NCT02014441|Secondary|Percentage of Participants With Detectable Talimogene Laherparepvec DNA in Oral Mucosa|Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of participants with detectable talimogene laherparepvec DNA on swabs taken from oral mucosa at any time during treatment is reported.|Cycle 1 on days 1 (pre-dose), 8, and 15, cycles 2 and 3 on days 1 (pre-dose), and 8, cycle 4 and subsequent cycles (up to 37) on day 1 (pre-dose), Cycle 25 on day 1 (pre-dose) and day 8.|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one oral mucosa swab collected during treatment.||percentage of participants|||Number
652840|NCT01998360|Secondary|Cosmetic Result|"Regular: scar line straight without any irregularity
Irregular: Some irregularity to scar line
Scalloped: wavy appearane to scar line"|6 weeks|||participants|||Number
652093|NCT02014441|Secondary|Percentage of Samples From Oral Mucosa With Detectable Talimogene Laherparepvec Virus|If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity. The percentage of samples taken from oral mucosa with detectable talimogene laherparepvec virus at any time during treatment (cycles 1-37) is reported.|Cycle 1 on days 1 (pre-dose), 8, and 15, cycles 2 and 3 on days 1 (pre-dose), and 8, cycle 4 and subsequent cycles (up to 37) on day 1 (pre-dose), Cycle 25 on day 1 (pre-dose) and day 8.|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one oral mucosa swab collected during treatment with a positive qPCR result.||percentage of samples|samples||Number
652094|NCT02014441|Secondary|Percentage of Samples From Oral Mucosa With Detectable Talimogene Laherparepvec DNA|Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of swab samples from oral mucosa with detectable talimogene laherparepvec DNA at any time during treatment (cycles 1 - 37) is reported.|Cycle 1 on days 1 (pre-dose), 8, and 15, cycles 2 and 3 on days 1 (pre-dose), and 8, cycle 4 and subsequent cycles (up to 37) on day 1 (pre-dose), cycle 25 on day 1 (pre-dose) and day 8.|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one oral mucosa swab collected during treatment.||percentage of samples|Samples||Number
652095|NCT02014441|Secondary|Percentage of Participants With Detectable Talimogene Laherparepvec Virus on the Surface of Injected Lesions|If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity. The percentage of participants with detectable talimogene laherparepvec virus on swabs taken from the surface of injected lesions at any time during cycles 1 to 3 is reported.|Cycle 1 on days 2, 3, 8, and 15, cycle 2 on days 1 (pre-dose), 2, 3, and 8, cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one injected lesion swab collected with a positive qPCR result.||percentage of participants|||Number
652096|NCT02014441|Secondary|Percentage of Participants With Detectable Talimogene Laherparepvec DNA on the Surface of Injected Lesions|Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of participants with detectable talimogene laherparepvec DNA swabs taken from the surface of injected lesions at any time during cycles 1 to 3 is reported.|Cycle 1 on days 2, 3, 8, and 15, cycle 2 on days 1 (pre-dose), 2, 3, and 8, cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one injected lesion swab collected.||percentage of participants|||Number
652097|NCT02014441|Secondary|Percentage of Samples From the Surface of Injected Lesions With Detectable Talimogene Laherparepvec Virus|If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity. The percentage of samples taken from the surface of injected lesions with detectable talimogene laherparepvec virus at any time during cycles 1 to 3 is reported.|Cycle 1 on days 2, 3, 8, and 15, cycle 2 on days 1 (pre-dose), 2, 3, and 8, cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one injected lesion swab collected with a positive qPCR result.||percentage of samples|samples||Number
652098|NCT02014441|Secondary|Percentage of Samples From the Surface of Injected Lesions With Detectable Talimogene Laherparepvec DNA|Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of swab samples from the surface of injected lesions with detectable talimogene laherparepvec DNA at any time during cycles 1 to 3 is reported.|Cycle 1 on days 2, 3, 8, and 15, cycle 2 on days 1 (pre-dose), 2, 3, and 8, cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one injected lesion swab collected.||percentage of samples|Samples||Number
652099|NCT02014441|Secondary|Percentage of Participants With Detectable Talimogene Laherparepvec Virus on the Exterior of the Occlusive Dressing|If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity. The percentage of participants with detectable talimogene laherparepvec virus on the exterior of the occlusive dressing at any time during cycles 1 to 3 is reported.|Cycle 1 on days 2, 3, 8, and 15, cycle 2 on days 1 (pre-dose), 2, 3, and 8, cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab collected from the exterior of the occlusive dressing with a detectable qPCR result.||percentage of participants|||Number
652100|NCT02014441|Secondary|Percentage of Participants With Detectable Talimogene Laherparepvec DNA on the Exterior of the Occlusive Dressing|Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of participants with detectable talimogene laherparepvec DNA on the exterior of the occlusive dressing at any time during cycles 1 to 3 is reported.|Cycle 1 on days 2, 3, 8, and 15, cycle 2 on days 1 (pre-dose), 2, 3, and 8, cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab collected from the exterior of the occlusive dressing.||percentage of participants|||Number
652101|NCT02014441|Secondary|Percentage of Samples With Detectable Talimogene Laherparepvec Virus on the Exterior of the Occlusive Dressing|If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity. The percentage of swab samples from the exterior of the occlusive dressing with detectable talimogene laherparepvec virus at any time during cycles 1 to 3 is reported.|Cycle 1 on days 2, 3, 8, and 15, cycle 2 on days 1 (pre-dose), 2, 3, and 8, cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab collected from the exterior of the occlusive dressing with a detectable qPCR result.||percentage of samples|samples||Number
652112|NCT02014272|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)|Tmax was reported for rifampicin and isoniazid.|0 hour (pre-dose), 0.25, 0.5, 0.75, 1, 1.33 (1 hour 20 minutes), 1.67 (1 hour 40 minutes), 2, 2.33 (2 hours 20 minutes), 2.67 (2 hours 40 minutes), 3, 3.5, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1|Pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest.||hour||Full Range|Median
652102|NCT02014441|Secondary|Percentage of Samples With Detectable Talimogene Laherparepvec DNA on the Exterior of the Occlusive Dressing|Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of swab samples from the exterior of the occlusive dressing with detectable talimogene laherparepvec DNA at any time during cycles 1 to 3 is reported.|Cycle 1 on days 2, 3, 8, and 15, cycle 2 on days 1 (pre-dose), 2, 3, and 8, cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab collected from the exterior of the occlusive dressing.||percentage of samples|samples||Number
652103|NCT02014441|Secondary|Percentage of Participants With Clearance of Talimogene Laherparepvec DNA From Urine|A participant was defined as having cleared talimogene laherparepvec if a negative urine sample was obtained following a prior positive test and if there were no subsequent positive tests.|Cycles 1 and 2 on days 1 (pre-dose and 1, 4, and 8 hours post-dose), 2, 3, 8, and 15 (cycle 1 only), cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).|Participants received at least 1 dose of talimogene laherparepvec, had at least 2 post-dose urine samples collected within the same dosing cycle with at least 1 positive talimogene laherparepvec DNA sample and at least 1 subsequent sample at any time during the cycle.||percentage of participants||95% Confidence Interval|Number
652104|NCT02014441|Secondary|Percentage of Participants With Clearance of Talimogene Laherparepvec DNA From Blood|A participant was defined as having cleared talimogene laherparepvec if a negative blood sample was obtained following a prior positive test and if there were no subsequent positive tests.|Cycles 1 and 2 on days 1 (pre-dose and 1, 4, and 8 hours post-dose), 2, 3, 8, and 15 (cycle 1 only), cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).|Participants must have received at least 1 dose of talimogene laherparepvec, had at least 2 post-dose blood samples collected within the same dosing cycle with at least 1 positive talimogene laherparepvec DNA sample and at least 1 subsequent sample at any time during the cycle.||percentage of participants||95% Confidence Interval|Number
652105|NCT02014441|Primary|Percentage of Participants With Detectable Talimogene Laherparepvec Deoxyribonucleic Acid (DNA) During the First Three Cycles|Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of participants with detectable talimogene laherparepvec DNA in blood or urine at any time during cycles 1 to 3 is reported.|Cycles 1 and 2 on days 1 (pre-dose and 1, 4, and 8 hours post-dose), 2, 3, 8, and 15 (cycle 1 only), cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).|Participants who were enrolled, received at least 1 dose of talimogene laherparepvec, and had at least 1 postdose blood/urine sample collected.||percentage of participants||95% Confidence Interval|Number
652106|NCT02014402|Secondary|Prevalence of Treatment Failures|Protocol-defined bleeding at the target bleeding site after the start of treatment or the use of alternative hemostatic treatments or maneuvers at the target bleeding site after the start of treatment|From start of treatment up to surgical closure by layers of the exposed surgical field containing the TBS, a median of 34 minutes|Data are presented for subjects in the Human Thrombin and Bovine Thrombin treatment groups in the mITT population||percent of subjects|||Number
652107|NCT02014402|Secondary|Cumulative Proportion of Subjects Having Achieved Hemostasis at the Target Bleeding Site by Specified Time Points|"Cumulative proportion of subjects having achieved hemostasis by each of the following time points:
At 3 minutes following start of study treatment
At 4 minutes following start of study treatment"|From start of treatment until 4 minutes after treatment start|Data are presented for subjects in the Human Thrombin and Bovine Thrombin treatment groups in the mITT population||percent of subjects achieving hemostasis|||Number
652108|NCT02014402|Primary|Proportion of Subjects Achieving Hemostasis by Five Minutes After Treatment Start at the TBS|Subjects achieving hemostasis at the target bleeding site by 5 minutes following the start of treatment without the occurrence of re-bleeding until the completion of surgical closure|From start of treatment until 5 minutes after treatment start|Data are presented for subjects in the Human Thrombin and Bovine Thrombin treatment groups in the modified intent-to-treat (mITT) population||percent of subjects achieving hemostasis|||Number
652109|NCT02014363|Primary|Change From Baseline in Baseline-adjusted (Montgomery-Asberg Depression Scale) MADRS Score at the End of Treatment.|The mean difference in baseline-adjusted MADRS score at the end of treatment in the per protocol population using the last observation carried forward (LOCF) method. MADRS is used to assess the range of symptoms that are most frequently observed in patients with major depression. The MADRS test includes 10 items and uses a 0 to 6 severity scale, with higher scores indicating increasing depressive symptoms. The total MADRS score is derived by adding all the scores from the 10 items, meaning the lowest possible score is 0 and the highest possible is 60.|Baseline (start of randomized treatment) and 8 weeks post start of treatment|Per protocol population (all subjects of the full analysis set for whom no relevant protocol deviations were documented).||Scores on a scale||Standard Error|Least Squares Mean
652110|NCT02014272|Other Pre-specified|Number of Participants With Laboratory Test Abnormalities|Criteria for laboratory tests abnormalities included: hemoglobin, hematocrit and red blood cells (less than [<] 0.8*lower limit of normal[LLN]); leucocytes (<0.6/ greater than [>] 1.5*limit of reference range [LRR]); platelets (<0.5/>1.75*LRR); neutrophils, lymphocytes (<0.8/>1.2*LRR); eosinophils, basophils, monocytes (>1.2*upper LN [ULN]); bilirubin (>1.5*ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (>3*ULN); creatinine, urea (>1.3*ULN); fasting glucose (<0.6 />1.5*LRR); uric acid (>1.2*ULN); sodium (<0.95/>1.05*LRR); potassium, calcium, chloride, bicarbonate (<0.9/>1.1*LRR); albumin, total protein (<0.8/>1.2*LRR); creatine kinase (>2.0*ULN); urine red blood cells (RBCs), urine white blood cells (WBCs) (>=20 high-powered field). Total number of participants with any laboratory abnormalities was reported.|Screening up to Day 2 of intervention period 2|Safety analysis set consisted of all participants who received at least 1 dose of study medication. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||participants|||Number
652111|NCT02014272|Other Pre-specified|Number of Participants With Clinically Significant Changes in Vital Signs|Criteria for clinical significant change in vital signs: systolic blood pressure (BP) less than (<) 90 millimeters of mercury (mmHg), diastolic BP <50 mmHg, supine and sitting heart rate <40 beats per minute (bpm) or greater than (>) 120 bpm, standing and erect heart rate <40 bpm or >140 bpm. Maximum change from baseline in systolic BP >=30 mmHg, maximum change from baseline in diastolic BP >=20 mmHg. Participants who met the criteria were reported.|Screening up to Day 2 of intervention period 2|Safety analysis set consisted of all participants who received at least 1 dose of study medication.||participants|||Number
652113|NCT02014272|Secondary|Plasma Decay Half-Life (t1/2)|Plasma decay half life (t1/2) was reported for rifampicin and isoniazid.|0 hour (pre-dose), 0.25, 0.5, 0.75, 1, 1.33 (1 hour 20 minutes), 1.67 (1 hour 40 minutes), 2, 2.33 (2 hours 20 minutes), 2.67 (2 hours 40 minutes), 3, 3.5, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1|Pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. Here, n=participants in the treatment group who were evaluable for this measure for specified drug of each group with reportable t½ values, respectively.||hour||Standard Deviation|Mean
652114|NCT02014272|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞) was reported for rifampicin and isoniazid. It is obtained from AUC (0 - t) plus AUC (t - ∞).|0 hour (pre-dose), 0.25, 0.5, 0.75, 1, 1.33 (1 hour 20 minutes), 1.67 (1 hour 40 minutes), 2, 2.33 (2 hours 20 minutes), 2.67 (2 hours 40 minutes), 3, 3.5, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1|Pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. Here, n=participants in the treatment group who were evaluable for this measure for specified drug of each group with reportable AUC (0 - ∞) values, respectively.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
652115|NCT02014272|Primary|Maximum Observed Plasma Concentration (Cmax)|Cmax was reported for rifampicin and isoniazid.|0 hour (pre-dose), 0.25, 0.5, 0.75, 1, 1.33 (1 hour 20 minutes), 1.67 (1 hour 40 minutes), 2, 2.33 (2 hours 20 minutes), 2.67 (2 hours 40 minutes), 3, 3.5, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1|Pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
652116|NCT02014272|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) was reported for rifampicin and isoniazid.|0 hour (pre-dose), 0.25, 0.5, 0.75, 1, 1.33 (1 hour 20 minutes), 1.67 (1 hour 40 minutes), 2, 2.33 (2 hours 20 minutes), 2.67 (2 hours 40 minutes), 3, 3.5, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1|Pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest.||(nanogram*hour) per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
652117|NCT02014051|Other Pre-specified|Maximum Tolerated Dose (MTD)|MTD was investigated with an index of DLT|Up to 18 weeks||||||Number
652118|NCT02014051|Secondary|Hematologic Improvement Effect (IWG 2006 Criteria, Responses Must Last at Least 8 Weeks)|"Definition
Hematologic Improvement Erythrocyte (HI-E):
Hgb increase by >= 1.5 g/dL Relevant reduction of units of red blood cell (RBC) transfusions by an absolute number of at least 4 RBC transfusions/8 week compared with the pretreatment transfusion number in the previous 8 week. Only RBC transfusions given for a Hgb of <= 9.0 g/dL pretreatment will count in the RBC transfusion response evaluation
Hematologic Improvement Platelet (HI-P):
Absolute increase of >= 30×10^9/L for patients starting with > 20×10^9/L platelets Increase from < 20×10^9/L to > 20×10^9/L and by at least 100%
Hematologic Improvement Neutrophil (HI-N):
At least 100% increase and an absolute increase > 0.5×10^9/L
Progressive disease / Relapse:
At least 1 of the following:
At least 50% decrement from maximum response levels in granulocytes or platelets Reduction in Hgb by >= 1.5 g/dL Transfusion dependence"|Up to 18 weeks|||participants|||Number
652119|NCT02014051|Secondary|Hematologic Remission Effect (IWG 2006 Criteria, Responses Sustained >= 4 Weeks)|"Definition
Complete remission (CR) Bone marrow: <= 5% myeloblasts; normal maturation of all cell lines Peripheral blood: Hemoglobin (Hgb) >= 11 g/dL, Platelets >= 100×10^9/L, Neutrophils >= 1.0×10^9/L, Blasts 0%
Partial remission (PR) Same as CR except bone marrow blasts decreased by >= 50% over pretreatment but still > 5%
Marrow CR Bone marrow: <= 5% myeloblasts and decrease by >= 50% over pretreatment Peripheral blood: will be noted in addition to marrow CR
Stable disease Failure to achieve at least PR, but no evidence of progression for > 8 weeks Disease progression
Patients with:
Less than 5% blasts: >= 50% increase in blasts to > 5% blasts 5%-10% blasts: >= 50% increase to > 10% blasts 10%-20% blasts: >= 50% increase to > 20% blasts 20%-30% blasts: >= 50% increase to > 30% blasts
Any of the following:
At least 50% decrement from maximum remission/response in granulocytes or platelets Reduction in Hgb by >= 2 g/dL Transfusion dependence"|Up to 60 weeks|||participants|||Number
652120|NCT02014051|Primary|Number of Participants Who Experienced Dose-limiting Toxicities (DLTs)|"A DLT was defined as adverse events for which a causal relationship with the investigational drug could not be ruled out and which met the following criteria that occurred by the final observation in Cycle 1. DLTs were also assessed in the Efficacy and Safety Assessment Committee.
Criteria
Grade 3 or higher non-hematologic toxicity. However, nausea, vomiting, diarrhoea, pyrexia, stomatitis, and esophagitis/dysphagia are excluded (Grade 3 nausea, vomiting, diarrhoea, and pyrexia that cannot be controlled with antiemetic, antidiarrheal, or antifebrile agents are regarded as DLTs)
Grade 3 or higher stomatitis, esophagitis, and dysphagia that persist for >= 4 days"|Up to 21 days|||participants|||Number
652121|NCT02014051|Primary|Adverse Events|Total Number Affected by Any Adverse Event (Details are presented in Adverse Event section)|Up to 18 weeks|||participants|||Number
652122|NCT02013830|Secondary|Overall Survival - Percentage of Participants Event Free at 12 Months|Overall Survival was defined as the time in months from randomization to date of death due to any cause. Participants without an event were censored the last time they were known to be alive.|Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.|ITT population.||percentage of participants||95% Confidence Interval|Number
652123|NCT02013830|Secondary|Overall Survival|Overall Survival was defined as the time in months from randomization to date of death due to any cause. Participants without an event were censored the last time they were known to be alive. Median Overall Survival was estimated using the Kaplan-Meier method.|Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.|ITT Population.||months||95% Confidence Interval|Median
652124|NCT02013830|Secondary|Overall Survival - Percentage of Participants With an Event|Overall Survival was defined as the time in months from randomization to date of death due to any cause. Participants without an event were censored the last time they were known to be alive.|Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.|ITT population.||percentage of participants|||Number
652841|NCT01998360|Secondary|Number of Participants With Complete Epithelialization (Completely Healed) at 4 Weeks|The number of participants with complete epithelialization (completely healed) at 4 weeks|1 month|||participants|||Number
652126|NCT02013830|Secondary|Time to Disease Progression|Time to progression was measured from time of treatment commencement to time of disease progression, or the date of death. Participants who were not progressed at the time of study completion (including participants who died before progressive disease) or who were lost to follow-up were censored at the date of their tumor assessment.|Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up|Intent-To-Treat (ITT) Population included all enrolled participants who received at least one dose of study medication.||months||95% Confidence Interval|Median
652127|NCT02013830|Secondary|Time to Disease Progression - Percentage of Participants With an Event|Time to progression was measured from time of treatment commencement to time of disease progression, or the date of death. Participants who were not progressed at the time of study completion (including participants who died before progressive disease) or who were lost to follow-up were censored at the date of last tumor assessment.|Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up|ITT population.||percentage of participants|||Number
652128|NCT02013830|Secondary|Percentage of Participants With Disease Control|The percentage of participants with disease control was based on assessment of confirmed CR, PR, or stable disease (SD) according to RECIST criteria. Confirmed responses were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. The best overall response achieved within the time from first drug administration to progressive disease or end of study was reported. CR was defined as complete disappearance of all target lesions and non-target disease, with the normalization of tumor marker levels. No new lesions. PR was defined as ≥ 30 % decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target lesions. Persistence of one or more non-target lesion(s) or/and maintenance of tumor marker levels above the normal limits. No new lesions. SD was defined as not qualifying for PR or progressive disease.|Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up|PP population.||percentage of participants||95% Confidence Interval|Number
652129|NCT02013830|Primary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. The best overall response achieved within the time from first drug administration to progressive disease or end of study was reported. CR was defined as complete disappearance of all target lesions and non-target disease, with the normalization of tumor marker levels. No new lesions. PR was defined as greater than or equal to (≥) 30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target lesions. Persistence of one or more non-target lesion(s) or/and maintenance of tumor marker levels above the normal limits. No new lesions.|Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up|Per Protocol (PP) Population included participants who: received greater than or equal to (≥) 1 dose of study medication, ≥6 weeks of treatment (unless excluded for allowed reasons), did not severely violate inclusion/exclusion criteria, had tumor assessment, greater than (>) 50% of first 6 weeks of treatment, and were not replaced.||percentage of participants||95% Confidence Interval|Number
652130|NCT02013817|Secondary|Percentage of Participants With Adverse Events (AEs)|AEs were recorded from the date of first medication administration until 28 days after the last trial medication.|Day 1 of Cycles 1, 2, 3, 4, 5, and 6 to 28 days after the last trial medication.|ITT population||percentage of participants|||Number
652131|NCT02013817|Secondary|Time to Next Treatment - Time to Event|Time to next treatment was calculated as the number of days from either discontinuation of the study drug or the administration of the last dose, until the participants needed next treatment.|Weeks 1, 5, 9, 12, 13, 17, 21 and 24 and every 8 weeks for 64 Weeks and every 6 months|||days||Standard Deviation|Mean
652132|NCT02013817|Secondary|Time to Next Treatment - Percentage of Participants With an Event|Time to next treatment was calculated as the number of days from either discontinuation of the study drug or the administration of the last dose, until the participants needed next treatment.|Weeks 1, 5, 9, 12, 13, 17, 21 and 24 and every 8 weeks for 64 Weeks and every 6 months|||percentage of participants|||Number
652133|NCT02013817|Secondary|Percentage of Participants With the Best Clinical Response by Visit (Clinical + Radiological Assessment)|Best clinical response was determined according to the NCI clinical evaluation and through radiological assessment. CR, CRi, CRu, PR, PRTox, PD, and SD were evaluated. Assessment of response was performed according to the NCI revised guidelines for the diagnosis and treatment of CLL with additional CT scan evaluation of lymphadenopathy during the treatment period (Radiological). Response assessment for interim (Week 12), end of induction (Week 24) and at Final Staging (4 weeks after last maintenance dose). LOCF method was used for missing data. Percentages are based on the number of nonmissing observations within each stratum.|Weeks 12 and 24 and at Final Staging (Week 4 after last maintenance dose)|ITT Population||percentage of participants||95% Confidence Interval|Number
652134|NCT02013817|Secondary|Percentage of Participants With the Best Clinical Response by Visit (Clinical Assessment)|Best clinical response was determined according to the NCI clinical evaluation and through radiological assessment. CR, CRi, CRu, partial remission (PR), partial remission with toxicity associated (PRTox), progressive disease (PD), and stable disease (SD) were evaluated. Assessment of response was performed according to the NCI revised guidelines for the diagnosis and treatment of CLL with additional CT scan evaluation of lymphadenopathy during the treatment period (Radiological). Response assessment for interim (Week 12), end of induction (Week 24) and at Final Staging (4 weeks after last maintenance dose). Last observation carried forward (LOCF) method was used for missing data. Percentages are based on the number of nonmissing observations within each stratum.|Weeks 12 and 24 and at Final Staging (Week 4 after last maintenance dose)|ITT Population||percentage of participants||95% Confidence Interval|Number
652155|NCT02013622|Secondary|Mean Change From Baseline to Week 16 in Go/No-Go Task (Mean Reaction Time)|Executive function and working memory were assessed using computer based neuropsychological instruments at Baseline and Week 16/Early Termination (ET). These instruments focused on measuring impulse inhibition.|Baseline and Week 16|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and Post-Baseline efficacy assessment. The LOCF dataset recorded at scheduled treatment phase visit or, if no observation was recorded at that visit, data carried forward from the previous scheduled treatment phase visit.||milliseconds||Standard Deviation|Mean
652842|NCT01998360|Secondary|Blood Loss|Number of ml of blood lost during the procedure, as assessed by the surgeon|During procedure (up to 1 hour)|||ml||Inter-Quartile Range|Median
652135|NCT02013817|Primary|Percentage of Participants With a Best Clinical Response of Clinical Remission (CR)|Best clinical response was determined according to the National Cancer Institute (NCI) Clinical and Clinical plus (+) Radiological evaluations by central response assessment. Assessment of response was performed according to the NCI revised guidelines for the diagnosis and treatment of chronic lymphocytic lymphoma (CLL) with additional computerized tomography (CT) scan evaluation of lymphadenopathy. Per NCI guidelines, CR requires all of the following criteria at least 2 months after the last treatment: no lymphadenopathy (Ly)/ hepatomegaly/ splenomegaly/constitutional symptoms; neutrophils greater than (>)1500 per microliter (/µL), platelets (PL) >100,000/µL, hemoglobin (Hb) >11.0 grams per deciliter (g/dL), lymphocytes (LC) (less than) <4000/µL, bone marrow (BM) sample must be normocellular for age, <30% LC.|Weeks 1, 5, 9, 12, 13, 17, 21 and 24|ITT Population||percentage of participants||95% Confidence Interval|Number
652136|NCT02013765|Primary|Percentage of Participants Progression Free at 12 and 24 Months||Months 12 and 24|FAS||percentage of participants||95% Confidence Interval|Number
652137|NCT02013765|Secondary|Percentage of Participants by Best Overall Response to Treatment|Per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. Complete response (CR) was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal [(short axis less than (<)10 millimeters (mm)]. No new lesions. Partial response (PR) was defined as greater than or equal to (≥)30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. Stable disease (SD) was defined as not qualifying for CR, PR, or progressive disease (PD).|Screening, every 3 months during treatment (up to 37 weeks), and at end of treatment|FAS||percentage of participants|||Number
652138|NCT02013765|Primary|Progression-Free Survival - Time to Event|The median time, in months, from the first study drug treatment to a PFS event.|Screening, every 3 months during treatment (up to 37 weeks), and at end of treatment|FAS||months||95% Confidence Interval|Median
652139|NCT02013765|Secondary|Percentage of Participants Surviving at 12 and 24 Months||Months 12 and 24|FAS||percentage of participants||95% Confidence Interval|Number
652140|NCT02013765|Secondary|Overall Survival - Time to Event|The median time, in months, from the start of study treatment to an OS event.|Screening, every 4 weeks during treatment (up to 37 weeks), at end of treatment, and every 3 months thereafter|FAS||months||95% Confidence Interval|Median
652141|NCT02013765|Secondary|Overall Survival (OS) - Percentage of Participants With an Event|OS was defined as the time from the start of study treatment to date of death due to any cause.|Screening, every 4 weeks during treatment (up to 37 weeks), at end of treatment, and every 3 months thereafter|FAS||percentage of participants|||Number
652142|NCT02013765|Primary|Progression-Free Survival (PFS) - Percentage of Participants With an Event|PFS was defined as the time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause.|Screening, every 3 months during treatment (up to 37 weeks), and at end of treatment|FAS||percentage of participants|||Number
652143|NCT02013687|Secondary|Assessment of Transmission Reducing Activity (TRA) of Malaria Parasite|Assessment of TRA, as measured by the standard membrane feeding assay (SMFA), showing ≥80% reduction of oocysts in Anopheles mosquito gut in ≥50% of the subjects with Study Day 196 sera (one month after the third vaccination) (Study Day 196) in either the 30 μg or 100 μg dose groups.|196 days|||% TRA||95% Confidence Interval|Mean
652144|NCT02013687|Secondary|Assessment of Transmission Reducing Activity (TRA) of Malaria Parasite|Assessment of TRA, as measured by the standard membrane feeding assay (SMFA), one month after the second vaccination (Study Day 84) in either the 30 μg or 100 μg dose groups.|84 days|||% TRA||95% Confidence Interval|Mean
652145|NCT02013687|Secondary|Assessment of Anti-Pfs25 IgG Following the Third Immunization.|Serum anti-Pfs25 antibody IgG titers determined using an ELISA unit assay.|196 days|"In the 30 µg + Alhydrogel group, 15 out of 16 patient samples were analyzed as 1 patient in the group had withdrawn from the study by study day 196. In the 100 µg + Alhydrogel group, 13 out of 16 patient samples were analyzed due to 2 patients in the group withdrawing from the study and an insufficient serum sample from a third patient."||Antibody Titer||95% Confidence Interval|Geometric Mean
652146|NCT02013687|Primary|Subjects With Solicited Local Adverse Events||336 days|||Participants|||Count of Participants
652147|NCT02013687|Primary|Subjects With Solicited Systemic Adverse Events||336 days|||Participants|||Count of Participants
652148|NCT02013687|Primary|Subjects With at Least One Adverse Event||336 days|||Participants|||Count of Participants
652149|NCT02013622|Secondary|Mean Change From Baseline to Week 16 in Barratt Impulsiveness Scale (BIS) 11-Item|The BIS-11 was a participant-rated scale designed to assess impulsive personality traits. The BIS-11 consisted of 30 items scored on a 4-point scale ranging from 1 (rarely/never) to 4 (almost always/always). The scores provided information to assess 6 first-order factors (attention, motor, self-control, cognitive complexity, perseverance, and cognitive instability impulsiveness) and 3 second-order factors (motor impulsiveness, non-planning impulsiveness, and attentional impulsiveness). The total score ranged from 30 to 120, with higher scores indicating impulsive personality traits. It took 10 to 15 minutes to complete the BIS-11. The BIS-11 was administered at the following visits: Baseline and Week 16/ET.|Baseline and Week 16|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and Post-Baseline efficacy assessment. The LOCF dataset recorded at scheduled treatment phase visit or, if no observation was recorded at that visit, data carried forward from the previous scheduled treatment phase visit.||Units on a scale||Standard Deviation|Mean
652156|NCT02013622|Secondary|Mean Change From Baseline to Week 16 in Go/No-Go Task (P-inhibition Failures)|Executive function and working memory were assessed using computer based neuropsychological instruments at Baseline and Week 16/Early Termination (ET). These instruments focused on measuring impulse inhibition. Proportions of inhibitory failures (p-inhibitory failures) is measured as the proportion of no-go targets in the go-cue condition in which a participant failed to inhibit a response.|Baseline and Week 16|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and Post-Baseline efficacy assessment. The LOCF dataset recorded at scheduled treatment phase visit or, if no observation was recorded at that visit, data carried forward from the previous scheduled treatment phase visit.||failures||Standard Deviation|Mean
652150|NCT02013622|Secondary|Mean Change From Baseline to Week 16 in Money Delay Discounting Task|"Delay discounting was a participant-completed task considered as an index of impulsive behavior. The participant chose between a reward they could have today and another that they could get after a specified amount of time. The participant would not receive the rewards, but was asked to make decisions as though he or she were really going to receive them. AUC is defined as area under the concentration-time curve; AUC for money is presented below. The data are computerized and reflect delay discounting and impulsivity (higher discounting shows greater impulsivity). To calculate the AUC, the X-axis is days, Y-axis is Money value, the actual area underneath the curve was calculated by summing the results for each delay and present value pair: x2 −x1[(y1 + y2)/2], where x1 and x2 are successive delays and y1 and y2 are the present values associated with those delays. The AUC can range from 1 (no discounting) to 0 (maximum discounting)."|Baseline and Week 16|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and Post-Baseline efficacy assessment. The LOCF dataset recorded at scheduled treatment phase visit or, if no observation was recorded at that visit, data carried forward from the previous scheduled treatment phase visit.||unitless||Standard Deviation|Mean
652151|NCT02013622|Secondary|Mean Change From Baseline to Week 16 in Food Delay Discounting Task|"Delay discounting was a participant-completed task considered as an index of impulsive behavior. The participant chooses between a reward they could have today and another that they could get after a specified amount of time. The participant would not receive the rewards, but was asked to make decisions as though he or she were really going to receive them. AUC is defined as area under the concentration-time curve; AUC for food is presented below. The data are computerized and reflect delay discounting and impulsivity (higher discounting shows greater impulsivity). To calculate the AUC, the X-axis is days, Y-axis is Food value, the actual area underneath the curve was calculated by summing the results for each delay and present value pair: x2 −x1[(y1 + y2)/2], where x1 and x2 are successive delays and y1 and y2 are the present values associated with those delays. The AUC can range from 1 (no discounting) to 0 (maximum discounting)."|Baseline and Week 16|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and Post-Baseline efficacy assessment. The LOCF dataset recorded at scheduled treatment phase visit or, if no observation was recorded at that visit, data carried forward from the previous scheduled treatment phase visit.||unitless||Standard Deviation|Mean
652152|NCT02013622|Secondary|Change From Baseline to Week 16 in the Mean Number of Impulsive Choices in the Delayed Reward Task (DRT)|Delay discounting was a participant-completed task considered as an index of impulsive behavior. It measured the extent to which the value of a reward decreased as the delay to obtaining that reward increased. During a training session, a single button with letter A or B appeared on the screen. The participant had to wait until the letter began to flash, and press the button only once. An amount of money was added to a counter and another single button appeared. During the test session, both buttons with letters A and B appeared on the screen. The participant had to choose one of the letters that remained; the other disappeared. The participant had to wait until the letter began to flash and then press the button again. An amount of money was added to the counter, and both letters appeared again. The data are computerized and reflect delay discounting and impulsivity (higher discounting shows greater impulsivity). A total score was not calculated for this task.|Baseline and Week 16|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and Post-Baseline efficacy assessment. The LOCF dataset recorded at scheduled treatment phase visit or, if no observation was recorded at that visit, data carried forward from the previous scheduled treatment phase visit.||Number of Impulsive Choices||Standard Deviation|Mean
652153|NCT02013622|Secondary|Mean Change From Baseline to Week 16 in Delay and Probability Discounting Task (DPDT) - Experiential Discounting Task Scores|Delay discounting measures the extent to which the value of a reward decreased as the delay to obtaining that reward increased. The propensity of participants to delay reward was assessed with an MCQ with completion of an Experiential Discounting task (EDT). The participant chose between different amounts of money available at different delays or with different chances (probability to get the money). At the end of the session, one of the choices was selected at random, and the participant received whatever they chose in response of that question (immediate, delayed, or probabilistic amount). Formula for h-value:value = A / (1 + hO) p is probability of reward and O is odds against.The value of h indicates how the value of a reward and the probability of its occurrence decreases. The data are computerized and reflect delay discounting and impulsivity (higher discounting and higher Probability discounting shows greater impulsivity). A total score is not computed for this task.|Baseline and Week 16|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and Post-Baseline efficacy assessment. The LOCF dataset recorded at scheduled treatment phase visit or, if no observation was recorded at that visit, data carried forward from the previous scheduled treatment phase visit.||unitless||Standard Deviation|Mean
652154|NCT02013622|Secondary|Mean Change From Baseline to Week 16 in Delay Discounting Task - Monetary Choice Questionnaire (MCQ) Scores|"Delay discounting was a participant-completed task is an index of impulsive behavior. It measured the extent to which the value of a reward decreased as the delay to obtaining that reward increased. The propensity of participants to delay reward was assessed with an MCQ. Discounting rate is estimated using, k= (A/V)1/D, where k is the discounting rate parameter, V is the immediate reward, A is the higher delayed reward and D is the amount of days to the delayed reward. The MCQ consists of 27 choices between immediate and delayed rewards. The participant chooses repeatedly between 2 hypothetical sums of money: a smaller amount now or a larger amount in the future (for example, would you prefer $27 today or $50 in 21 days?) The answers provide an estimate of the participant's discounting rate; higher discounting rates indicate greater impulsivity. A total score is not computed for all 27 questions."|Baseline and Week 16|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and Post-Baseline efficacy assessment. The LOCF dataset recorded at scheduled treatment phase visit or, if no observation was recorded at that visit, data carried forward from the previous scheduled treatment phase visit.||unitless||Standard Deviation|Mean
652354|NCT02009722|Secondary|Pruritus|Patients will be evaluated by a member of the study team at 24 hours after spinal administration. The number of patients with moderate or severe pruritus will be recorded.|24 hours after spinal|The number of patients at the most commonly used doses of IT medication (50, 75, 100 mcg for hydromorphone) and (100, 150 mcg) for morphine were used in analysis||participants|||Number
652843|NCT01998360|Secondary|Number of Participants With Adverse Events|Bleeding, hematoma, infection and other rare adverse events|1 month|||participants|||Number
652157|NCT02013622|Secondary|Mean Change From Baseline to Week 16 in Treatment Satisfaction Questionnaire for Medication (TSQM) Total Score|The TSQM-14 was a participant-rated scale used to assess subjective satisfaction with medication. The TSQM-14 provided scores on 4 domains: effectiveness (questions 1 to 3) side effects (4 to 8), convenience (9 to 11), and global satisfaction (12 to 14). The effectiveness domain was rated on a 7-point scale from “extremely satisfied” to “extremely dissatisfied.” The side effects domain provided an option to skip questions 5 to 8 if the subject provided a negative response to item number 4, ie, “As a result of taking this medication, do you currently experience any side effects at all?” Scores for each domain were transformed into a final score ranging from 0 to 100, with higher numbers indicating a higher level of satisfaction.|Baseline and Week 16|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The OC data set consisted of actual observations recorded at each visit during treatment phase and no missing data was imputed. MMRM was performed on the OC dataset.||Units on a scale||Standard Error|Least Squares Mean
652158|NCT02013622|Secondary|Mean Change From Baseline to Week 16 in Pittsburgh Sleep Quality Index (PSQI) Total Score|The PSQI was a self-rated questionnaire that assessed sleep quality and disturbances over a 1-month time interval. Seven domains were measured: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction over the last month. The PSQI contains 19 self-rated questions and 5 questions rated by the bed partner or roommate (if 1 is available). Only self-rated questions are included in the scoring.The 19 self-rated items are combined to form 7 “component” scores, each of which has a range of 0 - 3 points. In all cases, a score of “0” indicates no difficulty, while a score of “3” indicates severe difficulty. The 7 component scores are then added to yield 1 “global” score, with a range of 0 - 21 points, “0” indicating no difficulty and “21” indicating severe difficulties in all areas.|Baseline and Week 16|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The OC data set consisted of actual observations recorded at each visit during treatment phase and no missing data was imputed. MMRM was performed on the OC dataset.||Units on a scale||Standard Error|Least Squares Mean
652159|NCT02013622|Secondary|Mean Change From Baseline to Week 16 in Specific Levels of Functioning (SLOF) Total Score|The SLOF questionnaire used in this trial consists of 30 items grouped into 4 areas: social functioning, social acceptability, activities, and work skill. The SLOF scale correlates with a participant's quality of life. Total SLOF scale is sum of these 4 areas score. Each of the questions in the above domains is rated on a 5-point Likert scale. Scores on the instrument range from 30 to 150 with higher scores indicating the better the overall functioning of the patient.|Baseline and Week 16|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The OC data set consisted of actual observations recorded at each visit during treatment phase and no missing data was imputed. MMRM was performed on the OC dataset.||Units on a scale||Standard Error|Least Squares Mean
652160|NCT02013622|Secondary|Mean Change From Baseline to Week 16 in Personal and Social Performance (PSP) Total Score|The PSP was used to measure personal and social functioning in 4 domains: socially useful activities (e.g., work and study), personal and social relationships, self-care, and disturbing and aggressive behaviors. Impairment in each of these domains was rated as absent, mild, manifest, marked, severe, or very severe. These ratings were then converted to a total score based on a 100-point scale using algorithms to identify the appropriate 10-point interval, and the study physician's judgment to determine the total score within the 10-point interval. Participants with a PSP total score of 71 to 100 were considered to have mild functional difficulty. Scores of 31 to 70 represented manifest disabilities of various degrees, and ratings of 1 to 30 indicated minimal functioning that required intense support and/or supervision.|Baseline and Week 16|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The OC data set consisted of actual observations recorded at each visit during treatment phase and no missing data was imputed. MMRM was performed on the OC dataset.||Units on a scale||Standard Error|Least Squares Mean
652161|NCT02013622|Secondary|CGI-I Response Rate|The CGI-I response rate was defined as percentage of participants with CGI-I score of 1 (very much improved) or 2 (much improved).|Weeks 4, 8, 12, and 16|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and Post-Baseline efficacy assessment. The LOCF dataset recorded at scheduled treatment phase visit or, if no observation was recorded at that visit, data carried forward from the previous scheduled treatment phase visit.||percentage of participants|||Number
652162|NCT02013622|Secondary|Mean Clinical Global Impression-Improvement (CGI-I) Score|The improvement of each participants condition was rated for each participant using the CGI-I. The study physician rated the participants total improvement whether or not it was due entirely to drug treatment. To perform this assessment, the study physician answered the following question: “Compared to his/her condition at baseline, how much has the participant changed?” Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. The response at a given week was compared with the participants condition at Baseline prior to the first dose of study medication.|Week 1 to Week 16|All participants who took one dose of brexpiprazole and who had a valid Baseline assessment and Post-Baseline efficacy assessment, the last observation carried forward (LOCF) dataset recorded at scheduled treatment phase visit or, if no observation was recorded at that visit, data carried forward from the previous scheduled treatment phase visit.||Units on a scale||Standard Deviation|Mean
652163|NCT02013622|Secondary|Mean Change From Baseline to Week 16 in Clinical Global Impression-Severity (CGI-S) Score|The severity of illness for each participant was rated using the CGI-S. To perform this assessment, the study physician answered the following question: “Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?” Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.|Baseline and Week 16|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The OC data set consisted of actual observations recorded at each visit during treatment phase and no missing data was imputed. MMRM was performed on the OC dataset.||Units on a scale||Standard Error|Least Squares Mean
652164|NCT02013622|Secondary|Mean Change From Baseline to Week 16 Scores of the Following Negative Scale Items: Active Social Avoidance, Emotional Withdrawal, Passive/Apathetic Social Withdrawal, and Difficulty in Abstract Thinking|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS Negative Subscale ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms).|Baseline and Week 16|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The OC data set consisted of actual observations recorded at each visit during treatment phase and no missing data was imputed. MMRM was performed on the OC dataset.||Units on a scale||Standard Error|Least Squares Mean
652165|NCT02013622|Primary|Mean Change From Baseline to Week 16 in Positive and Negative Syndrome Scale (PANSS) Total Score|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline and Week 16|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The observed case (OC) data set consisted of actual observations recorded at each visit during treatment phase and no missing data was imputed. MMRM was performed on the OC dataset.||Units on a scale||Standard Error|Least Squares Mean
652166|NCT02013609|Secondary|Mean Change From Baseline to Week 12 in Barratt Impulsiveness Scale 11-Item (BIS-11) Total Score|The BIS-11 was a participant-rated scale designed to assess impulsive personality traits. The BIS-11 consisted of 30 items scored on a 4-point scale ranging from 1 (rarely/never) to 4 (almost always/always). The scores provided information to assess 6 first-order factors (attention, motor, self-control, cognitive complexity, perseverance, and cognitive instability impulsiveness) and 3 second-order factors (motor impulsiveness, non-planning impulsiveness, and attentional impulsiveness). The total score ranged from 30 to 120, with higher scores indicating impulsive personality traits.|Baseline and Week 12|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. Mixed model repeated measures was performed on the OC dataset.||Units on a scale||Standard Error|Least Squares Mean
652167|NCT02013609|Secondary|Mean Change From Baseline in Money Delay Discounting Task|"Delay discounting was a participant-completed task considered as an index of impulsive behavior. The participant chose between a reward they could have today and another that they could get after a specified amount of time. The participant would not receive the rewards, but was asked to make decisions as though he or she were really going to receive them. AUC is defined as area under the concentration-time curve; AUC for money is presented below. The data are computerized and reflect delay discounting and impulsivity (higher discounting shows greater impulsivity). To calculate the AUC, the X-axis is days, Y-axis is Money value, the actual area underneath the curve was calculated by summing the results for each delay and present value pair: x2 −x1[(y1 + y2)/2], where x1 and x2 are successive delays and y1 and y2 are the present values associated with those delays. The AUC can range from 1 (no discounting) to 0 (maximum discounting)."|Baseline and Week 12|Participants who took at least 1 dose of brexpiprazole with a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, data was carried forward from the previous scheduled treatment phase visit, if no observation was recorded at that visit.||unitless||Standard Deviation|Mean
652168|NCT02013609|Secondary|Mean Change From Baseline in Food Delay Discounting Task (DDT)|"Delay discounting was a participant-completed task considered as an index of impulsive behavior. The participant chooses between a reward they could have today and another that they could get after a specified amount of time. The participant would not receive the rewards, but was asked to make decisions as though he or she were really going to receive them. AUC is defined as area under the concentration-time curve; AUC for food is presented below. The data are computerized and reflect delay discounting and impulsivity (higher discounting shows greater impulsivity). To calculate the AUC, the X-axis is days, Y-axis is Food value, the actual area underneath the curve was calculated by summing the results for each delay and present value pair: x2 −x1[(y1 + y2)/2], where x1 and x2 are successive delays and y1 and y2 are the present values associated with those delays. The AUC can range from 1 (no discounting) to 0 (maximum discounting)."|Baseline and Week 12|Participants who took at least 1 dose of brexpiprazole with a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, data was carried forward from the previous scheduled treatment phase visit, if no observation was recorded at that visit.||unitless||Standard Deviation|Mean
652169|NCT02013609|Secondary|Mean Change From Baseline to Week 12 in Delay and Probability Discounting Task (DPDT)|The experiential discounting task (EDT) was a subject-completed computerized task designed to measure delay discounting, an index of impulsive behavior. It measured the extent to which the value of a reward decreased as the delay to obtaining that reward increased. The participant chose between different amounts of money available at different delays or with different chances (probability to get the money). At the end of the session, one of the choices was selected at random, and the participant received whatever they chose in response of that question (immediate, delayed, or probabilistic amount). Formula for h-value:value = A / (1 + hO) p is probability of reward and O is odds against.The value of h indicates how the value of a reward and the probability of its occurrence decreases.The data are computerized and reflect delay discounting and impulsivity (higher discounting and higher probability discounting shows greater impulsivity). A total score is not computed for this task.|Baseline and Week 12|Participants who took at least 1 dose of brexpiprazole with a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, data was carried forward from the previous scheduled treatment phase visit, if no observation was recorded at that visit.||unitless||Standard Deviation|Mean
652170|NCT02013609|Secondary|Mean Change From Baseline to Week 12 in the Number of Impulsive Choices in the Delayed Reward Task (DRT)|Delay discounting was a participant-completed task considered as an index of impulsive behavior. It measured the extent to which the value of a reward decreased as the delay to obtaining that reward increased. During a training session, a single button with letter A or B appeared on the screen. The participant had to wait until the letter began to flash, and press the button only once. An amount of money was added to a counter and another single button appeared. During the test session, both buttons with letters A and B appeared on the screen. The participant had to choose one of the letters that remained; the other disappeared. The participant had to wait until the letter began to flash and then press the button again. An amount of money was added to the counter, and both letters appeared again. The data are computerized and reflect delay discounting and impulsivity (higher discounting shows greater impulsivity). A total score was not calculated for this task.|Baseline and Week 12|Participants who took at least 1 dose of brexpiprazole with a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, data was carried forward from the previous scheduled treatment phase visit, if no observation was recorded at that visit.||Number of Impulsive Choices||Standard Deviation|Mean
652171|NCT02013609|Secondary|Mean Change From Baseline in Delay Discounting Task - Monetary Choice Questionnaire (MCQ) k Value|"Delay discounting was a participant-completed task is an index of impulsive behavior. It measured the extent to which the value of a reward decreased as the delay to obtaining that reward increased. The propensity of participants to delay reward was assessed with an MCQ. Discounting rate is estimated using, k= (A/V)1/D, where k is the discounting rate parameter, V is the immediate reward, A is the higher delayed reward and D is the amount of days to the delayed reward. The MCQ consists of 27 choices between immediate and delayed rewards. The participant chooses repeatedly between 2 hypothetical sums of money: a smaller amount now or a larger amount in the future (for example, would you prefer $27 today or $50 in 21 days?) The answers provide an estimate of the participant's discounting rate; higher discounting rates indicate greater impulsivity. A total score is not computed for all 27 questions."|Baseline and Week 12|Participants who took at least 1 dose of brexpiprazole with a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, data was carried forward from the previous scheduled treatment phase visit, if no observation was recorded at that visit.||unitless||Standard Deviation|Mean
652172|NCT02013609|Secondary|Mean Change From Baseline to Week 12 in Go/No-Go Task (Mean Reaction Time)|Executive function and working memory were assessed for the Go/No-go Task using computer-based and paper-pencil neuropsychological instruments. These instruments focused on measuring impulse inhibition.|Baseline and Week 12|Participants who took at least 1 dose of brexpiprazole with a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, data was carried forward from the previous scheduled treatment phase visit, if no observation was recorded at that visit.||milliseconds||Standard Deviation|Mean
652173|NCT02013609|Secondary|Mean Change From Baseline to Week 12 in Go/No-Go Task (P-inhibition Failure)|Executive function and working memory were assessed for the Go/No-go Task using computer-based and paper-pencil neuropsychological instruments. These instruments focused on measuring impulse inhibition. Proportions of inhibitory failures (p-inhibitory failures) is measured as the proportion of no-go targets in the go-cue condition in which a participant failed to inhibit a response.|Baseline and Week 12|Participants who took at least 1 dose of brexpiprazole with a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, data was carried forward from the previous scheduled treatment phase visit, if no observation was recorded at that visit.||failures||Standard Deviation|Mean
652174|NCT02013609|Secondary|Mean Change From Baseline to Week 12 in Kellner Symptom Questionnaire (KSQ) Total Score|KSQ is a subject-rated scale designed to assess distress using symptoms of depression, anxiety, anger-hostility and somatization. The questionnaire contains 92 items of which 68 items indicate symptoms and 24 items are antonyms of some of the symptoms that indicate well-being. The maximum score for each symptom subscale is 17, the well-being subscales 6 and for the total scale scores 23.The total subscale scores will be unevaluable if less than 19 of the 23 items are recorded. If 19 to 22 of the 23 items are recorded, the total subscale score is the mean of the recorded items multiplied by 23 and then rounded to the first decimal place. The total score will be unevaluable if less than 76 of the 92 items are recorded. If 76 to 91 of the 92 items and no less than 19 of the 23 items of each subscale are recorded, the total score will be the mean of the recorded items multiplied by 92 and then rounded to the first decimal place. A higher score indicates more distress than a lower score.|Baseline and Week 12|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. Mixed model repeated measures was performed on the OC dataset.||Units on a scale||Standard Error|Least Squares Mean
652175|NCT02013609|Secondary|Mean Change From Baseline to Week 12 in Massachusetts General Hospital-Cognitive and Physical Functioning Questionnaire (MGH-CPFQ) Total Score|The MGH-CPFQ was a participant-rated scale designed to assess cognitive and executive dysfunction including symptoms of fatigue in mood and anxiety disorders. The MGH-CPFQ consisted of 7 items, each rated on a scale from 1 (greater than normal functioning) to 6 (poorer than normal functioning). The total score of the 7 items ranged from 7 to 42.|Baseline and Week 12|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. Mixed model repeated measures was performed on the OC dataset.||Units on a scale||Standard Error|Least Squares Mean
652184|NCT02013609|Secondary|Mean Change From Baseline to Week 12 in Clinical Global Impression-Severity (CGI-S) Total Score|The severity of illness for each participant was rated using the CGI-S. To perform this assessment, the study physician answered the following question: “Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?” Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.|Baseline and Week 12|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment.||Units on a scale||Standard Error|Least Squares Mean
652844|NCT01998360|Primary|Intraoperative Duration|The number of minutes required to perform the surgical procedure|1 hour|||Min||Inter-Quartile Range|Median
652176|NCT02013609|Secondary|Mean Change From Baseline to Week 12 in Social Adaptation Self-evaluation Scale (SASS) Total Score|The SASS was a self-rated instrument to assess the social motivation and behavior in participants with depression. It contained 21 items covering the different aspects of social interactions, global social attitude, and self-perception. The SASS total score will be un-evaluable if less than 16 of the 20 items (for item number 1 and item number 2, participant is to answer either one of these) are recorded. If 16 to 19 of the 20 items are recorded, the SASS total score will be the mean of the recorded items multiplied by 20 and then rounded to the first decimal place.Each item is scored from 0 to 3, corresponding to minimal and maximal social adjustment, with a total score range of 0 to 60 (higher scores, indicating worse outcome).|Baseline and Week 12|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. Mixed model repeated measures was performed on the OC dataset.||Units on a scale||Standard Error|Least Squares Mean
652177|NCT02013609|Secondary|Mean Change From Baseline to Week 12 in Sheehan Disability Scale (SDS) Single Item Sub-scores|The SDS was a self-rated instrument used to measure the effect of the participant's symptoms on work/school, social life, and family/home responsibilities. The SDS was a visual analogue scale that used spatio-visual, numeric, and verbal descriptive anchors simultaneously to assess disability across the 3 domains. The number most representative of how much each area was disrupted by symptoms was marked along the line from 0 = not at all to 10 = extremely. Scores of 5 and above were associated with significant functional impairment.|Baseline and Week 12|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. Mixed model repeated measures was performed on the OC dataset.||Units on a scale||Standard Error|Least Squares Mean
652178|NCT02013609|Secondary|Mean Change From Baseline to Week 12 in Sheehan Disability Scale (SDS) 3-item Total/Summed Score|The SDS was a self-rated instrument used to measure the effect of the participant's symptoms on work/school, social life, and family/home responsibilities. The SDS was a visual analogue scale that used spatio-visual, numeric, and verbal descriptive anchors simultaneously to assess disability across the 3 domains. The number most representative of how much each area was disrupted by symptoms was marked along the line from 0 = not at all to 10 = extremely. Scores of 5 and above were associated with significant functional impairment. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired).|Baseline and Week 12|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. Mixed model repeated measures was performed on the OC dataset.||Units on a scale||Standard Error|Least Squares Mean
652179|NCT02013609|Secondary|Mean Change From Baseline to Week 12 in Hamilton Depression Rating Scale (HAM-D17) Total Score|The HAM-D17 was utilized as an assessment of a participants level of depression and was administered utilizing the Structured Interview Guide for the Hamilton Depression Rating Scale (SIGH-D). Detailed instructions for administration of this structured interview were provided in the SIGH-D. HAM-D17 is a 17-item questionnaire with a total score of 0 to 52 with higher scores indicating more depressive symptoms.|Baseline and Week 12|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. Mixed model repeated measures was performed on the OC dataset.||Units on a scale||Standard Error|Least Squares Mean
652180|NCT02013609|Secondary|Percentage of Participants With MADRS Remission|MADRS remission rate, where remission is defined as MADRS Total Score ≤ 10 and 50% reduction in MADRS Total Score from Baseline to Week 12.|Baseline and Week 12|Participants who took at least 1 dose of brexpiprazole with a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, data was carried forward from the previous scheduled treatment phase visit, if no observation was recorded at that visit.||percentage of participants|||Number
652181|NCT02013609|Secondary|Percentage of Participants With MADRS Response|MADRS response rate was defined as ≥ 50% reduction in respective total scores from Baseline to Week 12.|Baseline and Week 12|Participants who took at least 1 dose of brexpiprazole with a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, data was carried forward from the previous scheduled treatment phase visit, if no observation was recorded at that visit.||percentage of particpants|||Number
652182|NCT02013609|Secondary|Number of Participants With CGI-I Response|The CGI-I response rate was defined as a CGI-I score of 1 (very much improved) or 2 (much improved).|Weeks 1, 2, 3, 4, 6, 8 ,10 and 12|Participants who took at least 1 dose of brexpiprazole with a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment; the last-observation-carried-forward (LOCF) dataset included data recorded at a scheduled visit or, data was carried forward from the previous scheduled visit, if no observation was recorded at that visit||participants|||Number
652183|NCT02013609|Secondary|Mean Clinical Global Impression-Improvement (CGI-I) Score at Week 12|The improvement of each participants condition was rated for each participant using the CGI-I. The study physician rated the participants total improvement whether or not it was due entirely to drug treatment. To perform this assessment, the study physician answered the following question: “Compared to his/her condition at baseline, how much has the participant changed?” Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. The response at a given week was compared with the participants condition at Baseline prior to the first dose of study medication.|Weeks 1, 2, 3, 4, 5, 6, 8, 10 and 12|Participants who took at least 1 dose of brexpiprazole with a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment; the last-observation-carried-forward (LOCF) dataset included data recorded at a scheduled visit or, data was carried forward from the previous scheduled visit, if no observation was recorded at that visit||Units on a scale||Standard Deviation|Mean
652217|NCT02013388|Primary|Pharmacokinetics: Day 1 AUClast|Day 1 AUClast plasma values from treatment groups completing 14 days of N91115 administration|Day 1|All patients that had plasma samples collected were included in the analysis||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
652218|NCT02013388|Primary|Safety and Tolerability of N91115|Assessments are based on numbers of subjects with abnormal clinical evaluations, abnormal laboratory assessments, and adverse events.|21 Days|All patients enrolled in the study were evaluated for safety endpoints||participants|||Number
652185|NCT02013609|Primary|Mean Change From Baseline to Week 12 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score|The MADRS was utilized as the primary efficacy assessment of the participant's level of depression and was administered utilizing the Structured Interview Guide for the MADRS (SIGMA). Detailed instructions for administration of this structured interview was provided in the SIGMA. The MADRS consists of 10 items, all rated on a 0 to 6 scale with 0 being the “best” rating and 6 being the “worst” rating. The MADRS Total Score is the sum of ratings for all 10 items. The possible Total scores are from 0 to 60.|Baseline and Week 12|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment.||Units on a scale||Standard Error|Least Squares Mean
652186|NCT02013544|Secondary|Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color|To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, the vaginal color (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.||units on a scale||Standard Error|Mean
652187|NCT02013544|Secondary|Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness|To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, the vaginal epithelial surface thickness (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.||units on a scale||Standard Error|Mean
652188|NCT02013544|Secondary|Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity|To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, the vaginal epithelial integrity (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.||units on a scale||Standard Error|Mean
652189|NCT02013544|Secondary|Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions|To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, the vaginal secretions (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy were analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.||units on a scale||Standard Error|Mean
652190|NCT02013544|Secondary|Change From Baseline to Week 12 in Severity of Vaginal Dryness|The severity of vaginal dryness was evaluated by a questionnaire filled out by women. The severity of vaginal dryness recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Efficacy analyses on vaginal dryness were performed on a sub-group of the Intent to Treat (ITT) population (defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria) who had self-identified moderate to severe vaginal dryness at Baseline.||units on a scale||Standard Error|Mean
652191|NCT02013544|Primary|Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Dyspareunia|The severity of dyspareunia was evaluated by a questionnaire filled out by women. The severity of dyspareunia recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.||units on a scale||Standard Error|Mean
652192|NCT02013544|Primary|Change From Baseline to Week 12 in Vaginal pH|A pH strip fixed on an Ayre spatula (or equivalent) was applied directly to the lateral wall of the vagina. The change in color of the pH indicator strip was compared to the color chart for pH evaluation. The corresponding pH value (with one decimal) was recorded. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.||units on a scale||Standard Error|Mean
652193|NCT02013544|Primary|Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear|The percentage of parabasal cells was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.||Percentage of parabasal cells||Standard Error|Mean
652219|NCT02013245|Secondary|Number of Participants With Three-cytokine-positive CD4+ T-cell Response|Measure of the kinetics of CD4+ T-cell responses to MTBVAC or BCG vaccination by tracking the expression of IFNγ, TNFα and IL-2 upon stimulation with live MTBVAC or BCG|Day 28|Number of Participants with Three-cytokine-positive CD4+ T-cell Response (per protocol analysis)||participants|||Number
652194|NCT02013544|Primary|Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear|The percentage of superficial cells was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.||Percentage of superficial cells||Standard Error|Mean
652195|NCT02013531|Secondary|Mean Change From Baseline in Barratt Impulsiveness Scale 11-item (BIS-11) Total Score|The BIS-11 was a participant-rated scale designed to assess impulsive personality traits. The BIS-11 consisted of 30 items scored on a 4-point scale ranging from 1 (rarely/never) to 4 (almost always/always). The scores provided information to assess 6 first-order factors (attention, motor, self-control, cognitive complexity, perseverance, and cognitive instability impulsiveness) and 3 second-order factors (motor impulsiveness, non-planning impulsiveness, and attentional impulsiveness). The total score ranged from 30 to 120, with higher scores indicating impulsive personality traits. The BIS-11 was administered at the following visits: Baseline and Week 6/ET.|Baseline, Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.||Units on a scale||Standard Deviation|Mean
652196|NCT02013531|Secondary|Mean Change From Baseline in Money Delay Discounting Task|"Delay discounting was a participant-completed task considered as an index of impulsive behavior. The participant chose between a reward they could have today and another that they could get after a specified amount of time. The participant would not receive the rewards, but was asked to make decisions as though he or she were really going to receive them. AUC is defined as area under the concentration-time curve; AUC for money is presented below. The data are computerized and reflect delay discounting and impulsivity (higher discounting shows greater impulsivity). To calculate the AUC, the X-axis is days, Y-axis is Money value, the actual area underneath the curve was calculated by summing the results for each delay and present value pair: x2 −x1[(y1 + y2)/2], where x1 and x2 are successive delays and y1 and y2 are the present values associated with those delays. The AUC can range from 1 (no discounting) to 0 (maximum discounting)."|Baseline, Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.||unitless||Standard Deviation|Mean
652197|NCT02013531|Secondary|Mean Change From Baseline in Food Delay Discounting Task|"Delay discounting was a participant-completed task considered as an index of impulsive behavior. The participant chooses between a reward they could have today and another that they could get after a specified amount of time. The participant would not receive the rewards, but was asked to make decisions as though he or she were really going to receive them. AUC is defined as area under the concentration-time curve; AUC for food is presented below. The data are computerized and reflect delay discounting and impulsivity (higher discounting shows greater impulsivity). To calculate the AUC, the X-axis is days, Y-axis is Food value, the actual area underneath the curve was calculated by summing the results for each delay and present value pair: x2 −x1[(y1 + y2)/2], where x1 and x2 are successive delays and y1 and y2 are the present values associated with those delays. The AUC can range from 1 (no discounting) to 0 (maximum discounting)."|Baseline, Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.||unitless||Standard Deviation|Mean
652198|NCT02013531|Secondary|Mean Change From Baseline to Week 6 in the Number of Impulsive Choices in the Delayed Reward Task (DRT)|Delay discounting was a participant-completed task considered as an index of impulsive behavior. It measured the extent to which the value of a reward decreased as the delay to obtaining that reward increased. During a training session, a single button with letter A or B appeared on the screen. The participant had to wait until the letter began to flash, and press the button only once. An amount of money was added to a counter and another single button appeared. During the test session, both buttons with letters A and B appeared on the screen. The participant had to choose one of the letters that remained; the other disappeared. The participant had to wait until the letter began to flash and then press the button again. An amount of money was added to the counter, and both letters appeared again. The data are computerized and reflect delay discounting and impulsivity (higher discounting shows greater impulsivity). A total score was not calculated for this task.|Baseline, Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.||Number of Impulsive Choices||Standard Deviation|Mean
652199|NCT02013531|Secondary|Mean Change From Baseline in Delay and Probability Discounting Task (DPDT) Scores|The experiential discounting task (EDT) was a subject-completed computerized task designed to measure delay discounting, an index of impulsive behavior. It measured the extent to which the value of a reward decreased as the delay to obtaining that reward increased. The participant chose between different amounts of money available at different delays or with different chances (probability to get the money). At the end of the session, one of the choices was selected at random, and the participant received whatever they chose in response of that question (immediate, delayed, or probabilistic amount). Formula for h-value: value = A / (1 + hO) p is probability of reward and O is odds against. The value of h indicates how the value of a reward and the probability of its occurrence decreases. The data are computerized and reflect delay discounting and impulsivity (higher discounting and higher probability discounting shows greater impulsivity). A total score is not computed for this task.|Baseline, Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.||unitless||Standard Deviation|Mean
652200|NCT02013531|Secondary|Mean Change From Baseline in Delay Discounting Task - Monetary Choice Questionnaire (MCQ) Score|"Delay discounting was a participant-completed task is an index of impulsive behavior. It measured the extent to which the value of a reward decreased as the delay to obtaining that reward increased. The propensity of participants to delay reward was assessed with an MCQ. Discounting rate is estimated using, k= (A/V)1/D, where k is the discounting rate parameter, V is the immediate reward, A is the higher delayed reward and D is the amount of days to the delayed reward. The MCQ consists of 27 choices between immediate and delayed rewards. The participant chooses repeatedly between 2 hypothetical sums of money: a smaller amount now or a larger amount in the future (for example, would you prefer $27 today or $50 in 21 days?) The answers provide an estimate of the participant's discounting rate; higher discounting rates indicate greater impulsivity. A total score is not computed for all 27 questions."|Baseline, Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.||unitless||Standard Deviation|Mean
652201|NCT02013531|Secondary|Mean Change From Baseline in Go/No-Go Task for Mean Reaction Time|Executive function and working memory were assessed for the Go/No-go Task using computer-based and paper-pencil neuropsychological instruments. These instruments focused on measuring impulse inhibition. The instrument was administered at the following visits: Baseline and Week 6/ET.|Baseline, Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.||milliseconds||Standard Deviation|Mean
652202|NCT02013531|Secondary|Mean Change From Baseline in Go/No-Go Task for P-inhibition Failures|Executive function and working memory were assessed for the Go/No-go Task using computer-based and paper-pencil neuropsychological instruments. These instruments focused on measuring impulse inhibition. The instrument was administered at the following visits: Baseline and Week 6/ET.|Baseline, Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.||failures||Standard Deviation|Mean
652203|NCT02013531|Secondary|Mean Change From Baseline in Kellner Symptom Questionnaire (KSQ)|KSQ is a subject-rated scale designed to assess distress using symptoms of depression, anxiety, anger-hostility and somatization. The questionnaire contains 92 items of which 68 items indicate symptoms and 24 items are antonyms of some of the symptoms that indicate well-being. The maximum score for each symptom subscale is 17, the well-being subscales 6 and for the total scale scores 23. A higher score indicates more distress than a lower score. The total subscale scores will be unevaluable if less than 19 of the 23 items are recorded. If 19 to 22 of the 23 items are recorded, the total subscale score is the mean of the recorded items multiplied by 23 and then rounded to the first decimal place. The total score will be unevaluable if less than 76 of the 92 items are recorded. If 76 to 91 of the 92 items and no less than 19 of the 23 items of each subscale are recorded, the total score will be the mean of the recorded items multiplied by 92 and then rounded to the first decimal place.|Baseline, Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.||Units on a scale||Standard Deviation|Mean
652204|NCT02013531|Secondary|Mean Change From Baseline in Massachusetts General Hospital-Cognitive and Physical Functioning Questionnaire (MGH-CPFQ) Total Score|The MGH-CPFQ was a participant-rated scale designed to assess cognitive and executive dysfunction including symptoms of fatigue in mood and anxiety disorders. The MGH-CPFQ consisted of 7 items, each rated on a scale from 1 (greater than normal functioning) to 6 (poorer than normal functioning). The total score of the 7 items ranged from 7 to 42, with higher scores indicative of a worse outcome. The MGH-CPFQ was administered at the following visits: Baseline and Week 6/ET.|Baseline, Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.||Units on a scale||Standard Deviation|Mean
652205|NCT02013531|Secondary|Mean Change From Baseline in Sheehan Disability Scale (SDS) Mean Score|The SDS was a self-rated instrument used to measure the effect of the participant's symptoms on work/school, social life, and family/home responsibilities. The SDS was a visual analogue scale that used spatio-visual, numeric, and verbal descriptive anchors simultaneously to assess disability across the 3 domains. The number most representative of how much each area was disrupted by symptoms was marked along the line from 0 = not at all to 10 = extremely. Scores of 5 and above were associated with significant functional impairment. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired).|Baseline, Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.||Units on a scale||Standard Deviation|Mean
652206|NCT02013531|Secondary|Mean Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score|The HAM-A was utilized for the evaluation of anxiety symptoms and was administered using the Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A). Detailed instructions for administration of this structured interview were provided in the SIGH-A. The HAM-A was administered at the following visits: screening, Baseline, Weeks 1, 2, 3, 4, and 6/ET. HAM-A is a 14-item scale with each item is scored on a scale from 0 (not present) to 4 (very severe) with a total score of 0 to 56, with higher scores indicating severe anxiety symptoms.|Baseline, Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. A MMRM analysis was performed.||Units on a scale||Standard Error|Least Squares Mean
652859|NCT01997723|Secondary|Technical Failure Rate|home PM tests that failed to provide technically adequate data for diagnosis. Technical failure(s) were tests where estimated total sleep time (TST) was ≤ 2 hours or portable monitor data of interpretable quality was less than 4 hours per recording.|4 days|||percentage of recordings|||Number
652207|NCT02013531|Secondary|Mean Change From Baseline in Hamilton Depression Rating Scale (HAM-D17) Total Score|The HAM-D17 was utilized as an assessment of a participants level of depression and was administered utilizing the Structured Interview Guide for the Hamilton Depression Rating Scale (SIGH-D). Detailed instructions for administration of this structured interview were provided in the SIGH-D. The HAM-D17 was administered at the following visits: screening, Baseline, and Week 6/ Early termination (ET). HAM-D17 is a 17-item questionnaire with a total score of 0 to 52 with higher scores indicating more depressive symptoms.|Baseline, Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.||Units on a scale||Standard Deviation|Mean
652208|NCT02013531|Secondary|Percentage of Participants With a MADRS Remission|MADRS remission rate, where remission is defined as MADRS Total Score ≤ 10 and 50% reduction in MADRS Total Score from Baseline to Week 6. The MADRS consists of 10 items, all rated on a 0 to 6 scale with 0 being the “best” rating and 6 being the “worst” rating. The MADRS Total Score is the sum of ratings for all 10 items. The possible Total scores are from 0 to 60, higher values indicate worse outcome.|Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.||Percentage of participants|||Number
652209|NCT02013531|Secondary|Percentage of Participants With a MADRS Response|MADRS response rate, where response is defined as ≥ 50% reduction in respective total scores from Baseline to Week 6. The MADRS consists of 10 items, all rated on a 0 to 6 scale with 0 being the “best” rating and 6 being the “worst” rating. The MADRS Total Score is the sum of ratings for all 10 items. The possible Total scores are from 0 to 60, higher values indicate worse outcome.|Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.||Percentage of participants|||Number
652210|NCT02013531|Secondary|Percentage of Participants With CGI-I Response Rate|The improvement of each participants condition was rated for each participant using the CGI-I. The study physician rated the participants total improvement whether or not it was due entirely to drug treatment. To perform this assessment, the study physician answered the following question: “Compared to his/her condition at baseline, how much has the participant changed?” Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. The response at a given week was compared with the participants condition at Baseline prior to the first dose of study medication.|Week 1 to Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.||percentage of participants|||Number
652211|NCT02013531|Secondary|Mean Clinical Global Impression-Improvement (CGI-I) Score at Week 6.|The improvement of each participants condition was rated for each participant using the CGI-I. The study physician rated the participants total improvement whether or not it was due entirely to drug treatment. To perform this assessment, the study physician answered the following question: “Compared to his/her condition at baseline, how much has the participant changed?” Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. The response at a given week was compared with the participants condition at Baseline prior to the first dose of study medication.|Baseline, Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.||Units on a scale||Standard Deviation|Mean
652212|NCT02013531|Secondary|Mean Change in Clinical Global Impression-Severity (CGI-S) Total Score|The severity of illness for each participant was rated using the CGI-S. To perform this assessment, the study physician answered the following question: “Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?” Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.|Baseline, Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. A MMRM analysis was performed.||Units on a scale||Standard Error|Least Squares Mean
652213|NCT02013531|Primary|Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|The MADRS is utilized as the primary efficacy assessment of a participant's level of depression. The MADRS consists of 10 items, all rated on a 0 to 6 scale with 0 being the “best” rating and 6 being the “worst” rating. The MADRS Total Score is the sum of ratings for all 10 items. The possible Total scores are from 0 to 60, with higher values indicating worse outcome.|Baseline, Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid Baseline and Post-Baseline efficacy assessment. A mixed model repeated measures (MMRM) analysis was performed.||Units on a scale||Standard Error|Least Squares Mean
652214|NCT02013388|Primary|Pharmacokinetics: Plasma Cmax Values on Day 14|Plasma Cmax values from Day 14 subjects with repeat administration of N91115|Day 14|All subjects completing plasma collection sampling for N91115||ng/mL||Geometric Coefficient of Variation|Geometric Mean
652215|NCT02013388|Primary|Pharmacokinetics: Day 1 Plasma Cmax Values|All subjects who completed sample collections for Day 1 plasma N91115|Day 1|All subjects that completed the plasma collection sampling were included in the analysis||ng/mL||Geometric Coefficient of Variation|Geometric Mean
652216|NCT02013388|Primary|Pharmacokinetics: AUCtau Day 14|Plasma analysis of AUCtau values from the end of the dosing period (Day 14) with N91115|Day 14|All patients that completed the required days of dosing to study end||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
652934|NCT01994746|Secondary|Time From Glucagon Administration to Return of Plasma Glucose to >/=70 mg/dL||0 to 90 minutes following glucagon administration||||||
652220|NCT02013245|Primary|Number of Participants With Adverse Events up to 210 Days After Vaccination|"Safety and reactogenicity for all subjects as determined by:
Occurrence of solicited symptoms during the 7-day follow-up period following vaccination and occurrence of unsolicited symptoms during the 210-day follow-up period following vaccination.
Occurrence of grade 3 vaccine related local and general symptoms during the 210-day follow-up period following vaccination and occurrence of serious adverse events throughout the entire study period.
Haematological and biochemical safety test levels prior and after vaccination"|7 months follow up|||participants|||Number
652221|NCT02013206|Secondary|Safety: Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events. A SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant.|Up to 2 years|Safety Population included all registered participant who received at least one study treatment and had at least one safety follow-up.||participants|||Number
652222|NCT02013206|Secondary|Overall Survival|Overall survival was defined as the time in months from the start of treatment to the date of death irrespective of the cause of death.|Up to 2 years|Safety Population included all participants with at least one study treatment and had at least one safety follow-up. Patients who had not died at the time of the final analysis were censored at the date of last contact.||months||95% Confidence Interval|Median
652223|NCT02013206|Secondary|Progression-Free Survival|Progression-Free Survival (PFS) was defined as the time in months from the start of treatment until the first date criteria for Progressive Disease (PD) were met (taking as reference the smallest measurements recorded since the treatment started), or the date of death for any reason in the absence of PD. Diagnosis of PD was made by objective criteria (RECIST criteria) on the target lesion(s), or by documenting, with Computerised Tomography/Magnetic Resonance Imaging (CT/MRI) scans, the presence of newly occurring lesion(s) arising outside the scanned areas of the target lesions.|Up to 2 years|Safety Population included all registered participants who received at least one study treatment and had at least one safety follow-up. Patients without PD at the time of analysis were censored on the date of the last tumour assessment. Patients without PD who received a second anti-cancer therapy were censored prior to start of new therapy.||months||95% Confidence Interval|Median
652224|NCT02013206|Secondary|Time to Progression|Time to progression was defined as the time from start of treatment until the first date criteria for Progressive Disease (PD) was met (taking as reference the smallest measurements recorded since the treatment started). Diagnosis of PD was made by objective criteria (RECIST criteria) on the target lesion(s), or by documenting, with Computerised Tomography/Magnetic Resonance Imaging (CT/MRI) scans, the presence of newly occurring lesion(s) arising outside the scanned areas of the target lesions. PD required at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Up to 2 years|Safety Population included all registered patients who received at least 1 dose of study treatment and had at least 1 safety follow-up. Patients without PD at the time of analysis were censored on the date of the last tumour assessment. Patients without PD who received a second anti-cancer therapy were censored prior to start of new therapy.||months||95% Confidence Interval|Median
652225|NCT02013206|Secondary|Duration of Response|Duration of overall response was defined as the time in months from Complete Response (CR) or Partial Response (PR) by Response Evaluation Criteria in Solid Tumours (RECIST) until the first date Progressive Disease (PD) was objectively documented (taking as reference for PD the smallest measurements recorded since the treatment started) or until the date of death. CR was defined as the disappearance of all target lesions; for non-target lesions disappearance of lesions and normal tumour marker levels.PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using as reference the Baseline sum LD. PD was defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Up to 2 years|Participants from the Intent-to-Treat (ITT) Population, that included all participants, with CR or PR. Patients still responding to treatment at the time of analysis were treated as censored observations for duration of response on the date of the last tumour assessment.||months||95% Confidence Interval|Median
652226|NCT02013206|Secondary|Disease Control Rate|Disease Control Rate was defined as the percentage of participants with Complete Response (CR), Partial Response (PR) or Stable Disease (SD) by Response Evaluation Criteria in Solid Tumours (RECIST). CR was defined as the disappearance of all target lesions; for non-target lesions disappearance of lesions and normal tumour marker levels. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using as reference the Baseline sum LD. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started; for non-target lesions persistence of one or more non-target lesion(s) and/or maintenance of tumour marker level above the normal limits.|Up to 2 years|Intent-to-Treat Population included all registered participants.||percentage of participants||95% Confidence Interval|Number
652227|NCT02013206|Secondary|Objective Response Rate|"Objective response rate was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) by Response Evaluation Criteria in Solid Tumours (RECIST). The best overall response was the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started). The patient's best response assignment depended on the achievement of both measurement and confirmation criteria. To be assigned the status of PR or CR, changes in tumour measurements were to be confirmed by repeated assessments no less than 4 weeks after the criteria for response were first met.
CR was defined as the disappearance of all target lesions; for non-target lesions disappearance of lesions and normal tumour marker levels. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using as reference the Baseline sum LD."|Up to 2 years|Intent-to-Treat Population included all registered participants.||percentage of participants||95% Confidence Interval|Number
655263|NCT01953328|Secondary|Change From Baseline in LDL-C at Week 12||Baseline and Week 12|Full analysis set||mg/dL||Standard Error|Least Squares Mean
652228|NCT02013206|Primary|Non-Progression Rate (NPR) at 8 Weeks|Non-Progressive Rate (NPR) was defined as the percentage of participants without progression (had stable disease (SD) or better) based on (Response Evaluation Criteria in Solid Tumours (RECIST) criteria 8 weeks after start of treatment. Diagnosis of Progressive Disease (PD) was made by objective criteria (RECIST criteria) on the target lesion(s), or by documenting, with Computerised Tomography/Magnetic Resonance Imaging (CT/MRI) scans, the presence of newly occurring lesion(s) arising outside the scanned areas of the target lesions. PD required at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Week 8|Intent-to-Treat Population included all registered participants.||percentage of participants||95% Confidence Interval|Number
652229|NCT02013167|Secondary|Time to a 10-point Decrease From Baseline in Global Health Status and Quality of Life or Death|"The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) is a 30-item questionnaire that assesses the health related quality of life of cancer patients. The EORTC QLQ-C30 consists of a global health status/quality of life (QoL) scale, 5 functional scales, 3 symptom scales, and 6 single items.
The global health/QoL scale consists of 2 questions that ask participants to rate their overall health and overall quality of life durig the past week on a scale from 1 (very poor) to 7 (excellent). The scale score was derived as the sum of each score and transformed to a scale from 0 to 100 where higher scores represent a high QoL.
Time to a ≥10-point decrease from baseline GHS/QoL or death, whichever came first, was calculated from baseline. Participants still alive and without a 10-point decrease in GHS/QoL EORTC QLQ-C30 were censored on their last EORTC QLQ-C30 assessment date."|From randomization until the data cut-off date of 04 January 2016; EORTC QLQ-C30 was assessed on day 1, 8, 15, and 29 during cycle 1; days 1, 15, and 29 in cycle 2 and each consolidation cycle, and 30-days following the last dose of drug treatment.|EORTC QLQ-C30 analysis set included all randomized participants with a non-missing baseline and at least 1 non-missing postbaseline result of any EORTC QLQ-C30 scales/item.||months||95% Confidence Interval|Median
652230|NCT02013167|Secondary|Number of Participants With Anti-blinatumomab Antibodies|Anti-blinatumomab binding antibodies were evaluated using a validated electrochemiluminescence (ECL)-based assay (binding assay). Samples positive for binding were analyzed using a cell-based bioassay to determine if the detected antibodies had neutralizing properties (neutralizing assay).|Samples were collected on day 29 at the end of cycle 2 and 30 days after the last dose of blinatumomab (median duration of treatment was 70 days).|Participants who received blinatumomab with available post-baseline antibody data.||participants|||Number
652231|NCT02013167|Secondary|100-Day Mortality After Allogeneic Hematopoietic Stem Cell Transplant|"The analysis of 100-day mortality after allogeneic HSCT was assessed for participants who achieved a best response of CR/CRh*CTi within 12 weeks of treatment initiation, who received an allogeneic HSCT and did not receive any additional anticancer treatment before the transplant. 100-day mortality after allogeneic HSCT was calculated relative to the date of allogeneic HSCT.
The 100-day mortality rate after allogeneic HSCT was defined as the percentage of participants having died up to 100 days after allogeneic HSCT estimated using the estimated time to death in percent calculated by Kaplan-Meier methods. Participants alive were censored on the last documented visit date or the date of the last phone contact when the patient was last known to have been alive."|100 days, from the date of allogeneic HSCT until the data cut-off date of 04 January 2016|Randomized participants with a best response of CR/CRh*/CRi within 12 weeks of treatment initiation and who received an allogeneic HSC without anti-cancer therapy prior to allogeneic HSCT.||percentage of participants||95% Confidence Interval|Number
652232|NCT02013167|Secondary|Number of Participants With Adverse Events|"Adverse events (AEs) were graded for severity according to the CTCAE version 4.0, where Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.
Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living.
Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living.
Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE. Treatment-related adverse events (TRAEs) were those assessed by the investigator as possibly related to blinatumomab based on response to the question: Is there a reasonable possibility that the event may have been caused by blinatumomab or other protocol-specified therapies/procedures?"|From first dose of protocol-specified therapy until 30 days after the last dose, up to the data cut-off date of 04 January 2016; median duration of treatment was 5 days in the SOC group and 70 days in the blinatumomab group.|All participants who received protocol-specified therapy analyzed according to the treatment they received.||participants|||Number
652233|NCT02013167|Secondary|Percentage of Participants Who Received an Allogeneic Hematopoietic Stem Cell Transplant (HSCT)||Up to the data cut-off date of 04 January 2016; maximum time on study was 23 months.|All randomized participants||percentage of participants||95% Confidence Interval|Number
652234|NCT02013167|Secondary|Percentage of Participants With Minimal Residual Disease (MRD) Within 12 Weeks of Treatment Initiation|Bone marrow samples were evaluated for MRD remission by a central laboratory. MRD remission was defined as the occurrence of an MRD level below 10^-4 measured by quantitative reverse transcription polymerase chain reaction (PCR) or flow cytometry.|12 weeks|All randomized participants||percentage of participants||95% Confidence Interval|Number
652235|NCT02013167|Secondary|Duration of Complete Remission/Complete Remission With Partial Hematological Recovery/Complete Remission With Incomplete Hematological Recovery (CR/CRh*/CRi)|Duration of CR/CRh*/CRi, calculated only for participants who achieved a CR/CRh*/CRi, was calculated from the date a CR/CRh*/CRi was first achieved until the earliest date of a disease assessment indicating a relapse event or death, whichever occurred first. Participants who did not have a relapse event were censored on their last disease assessment date.|Up to the data cut-off date of 04 January 2016; median observation time was 10.8 months in the SOC group and 7.2 months in the blinatumomab group.|Randomized participants with a best response of CR/CRh*/CRi within 12 weeks of treatment initiation.||months||95% Confidence Interval|Median
652355|NCT02009722|Secondary|Pruritus|Patients will be evaluated by a member of the study team at 12 hours after spinal administration. The number of patients with moderate or severe pruritus will be recorded.|12 hours after spinal|The number of patients at the most commonly used doses of IT medication (50, 75, 100 mcg for hydromorphone) and (100, 150 mcg) for morphine were used in analysis||participants|||Number
652236|NCT02013167|Secondary|Duration of Complete Remission|Duration of complete remission, calculated only for participants who achieved a CR, was calculated from the date a CR was first achieved until the earliest date of a disease assessment indicating a relapse event or death, whichever occurred first. Participants who did not have a relapse event were censored on their last disease assessment date.|Up to the data cut-off date of 04 January 2016; median observation time was 10.8 months in the SOC group and 7.0 months in the blinatumomab group.|Randomized participants with a best response of complete remission within 12 weeks of treatment initiation.||months||95% Confidence Interval|Median
652237|NCT02013167|Secondary|Event Free Survival (EFS)|"Event free survival was defined as the time from randomization until a documented relapse after achieving CR/CRh*/CRi or death, whichever occurred first. Participants who failed to achieve a CR/CRh*/CRi within 12 weeks of treatment initiation were considered as non-responders and assigned an EFS duration of 1 day. Participants still alive and relapse-free were censored on their last disease assessment date.
A relapse event was any one of the following:
Hematological relapse: proportion of blasts in bone marrow >5% or blasts in peripheral blood after documented CR or CRh* or CRi
Progressive disease: An increase from baseline of at least 25% of bone marrow blasts or an absolute increase of at least 5,000 cells/μL in the number of circulating leukemia cells
Extramedullary relapse: extramedullary lesion that is new or increased by 50% from nadir as assessed by Cheson criteria.
The Kaplan-Meier estimate of EFS at 6 months is reported."|6 months|All randomized participants||percentage of participants||95% Confidence Interval|Number
652238|NCT02013167|Secondary|Percentage of Participants With Complete Remission/Complete Remission With Partial Hematological Recovery/Complete Remission With Incomplete Hematological Recovery (CR/CRh*/CRi) Within 12 Weeks of Treatment Initiation|"Participants were evaluated for efficacy at the end of each treatment cycle via a central bone marrow aspiration and local peripheral blood counts.
Complete remission was defined as having ≤ 5% blasts in the bone marrow, no evidence of disease, and full recovery of peripheral blood counts: platelets > 100,000/μl, and ANC > 1,000/μl.
Complete Remission with partial hematological recovery (CRh*) was defined as ≤ 5% blasts in the bone marrow, no evidence of disease and partial recovery of peripheral blood counts: platelets > 50,000/μl, and ANC > 500/μl.
Complete remission with incomplete hematological recovery (CRi) was defined as ≤ 5% blasts in the bone marrow, no evidence of disease and incomplete recovery of peripheral blood counts: platelets > 100,000/μl or ANC > 1000 (but not both)."|12 weeks|All randomized participants||percentage of participants||95% Confidence Interval|Number
652239|NCT02013167|Secondary|Percentage of Participants With Complete Remission Within 12 Weeks of Treatment Initiation|"Participants were evaluated for efficacy at the end of each treatment cycle via a central bone marrow aspiration and local peripheral blood counts.
Complete Remission (CR) was defined as having ≤ 5% blasts in the bone marrow, no evidence of disease, and full recovery of peripheral blood counts: platelets > 100,000/μl, and absolute neutrophil count (ANC) > 1,000/μl. CR must have occurred within 12 weeks of the first dose of therapy."|12 weeks|All randomized participants||percentage of participants||95% Confidence Interval|Number
652240|NCT02013167|Primary|Overall Survival|Overall survival (OS) was calculated from time of randomization until death due to any cause. Participants still alive were censored at the date they were last known to be alive.|From randomization until the data cut-off date of 04 January 2016; median observation time was 11.8 months in the SOC group and 11.7 months in the blinatumomab group.|All randomized participants||months||95% Confidence Interval|Median
652241|NCT02013050|Secondary|"Percent of Patients With RECIST 1.1 Classification of Complete Response"|"The RECIST 1.1 scoring system evaluates both the defined (target) tumor, the non-target lesions, and the appearance of new lesions on radiologic scans as follows:
Target Lesion :
Complete Response (CR): All target lesions gone Partial Response (PR): >30% decrease from Baseline Progressive Disease (PD): >20% increase from smallest sum of longest diameter recorded since treatment started (best response) Stable Disease (SD): Neither PD nor PR
Non-Target Lesion:
Complete Response (CR): All non-target lesions gone,Tumor markers gone Stable Disease (SD): Persistence of ≥1 non-target lesion, Tumor marker level elevated Progressive Disease: Enlargement of non-target lesions"|12 months after end of therapy|||percentage of participants|||Number
652242|NCT02013050|Secondary|Survival||12 months after end of therapy|Safety Population: all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug that they actually received instead of the drug dose they were randomized. 2 patients were randomized but never received drug and are excluded. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942.||percentage of participants|||Number
652243|NCT02013050|Secondary|Incidence of Severe Oral Mucositis (SOM) in Patients Receiving Every 3rd Week Cisplatin||4 weeks after end of therapy|||percentage of participants|||Number
652244|NCT02013050|Secondary|Duration of Severe Oral Mucositis (SOM) in Patients Receiving Every 3rd Week Cisplatin||4 weeks after end of therapy|||days||95% Confidence Interval|Median
652245|NCT02013050|Secondary|"Percent of Patients With RECIST 1.1 Classification of Complete Response"|"The RECIST 1.1 scoring system evaluates both the defined (target) tumor, the non-target lesions, and the appearance of new lesions on radiologic scans as follows:
Target Lesion :
Complete Response (CR): All target lesions gone Partial Response (PR): >30% decrease from Baseline Progressive Disease (PD): >20% increase from smallest sum of longest diameter recorded since treatment started (best response) Stable Disease (SD): Neither PD nor PR
Non-Target Lesion:
Complete Response (CR): All non-target lesions gone,Tumor markers gone Stable Disease (SD): Persistence of ≥1 non-target lesion, Tumor marker level elevated Progressive Disease: Enlargement of non-target lesions"|4 weeks after end of therapy|||percentage of participants|||Number
652246|NCT02013050|Secondary|Incidence of Clinically Reported, Non-fungal Infections||4 weeks after end of therapy|||percentage of participants|||Number
652247|NCT02013050|Secondary|Duration of Severe Oral Mucositis (SOM)|OM was evaluated using the published World Health Organization (WHO) OM grading scale that uses a scale of 0 to 4. SOM is defined as a WHO score of greater than or equal to 3.|4 weeks after end of therapy|||WHO score * days||95% Confidence Interval|Median
652248|NCT02013050|Secondary|Residual Severe Oral Mucositis (SOM)|OM was evaluated using the published World Health Organization (WHO) OM grading scale that uses a scale of 0 to 4. SOM is defined as a WHO score of greater than or equal to 3.|4 weeks after end of therapy|||percentage of participants|||Number
653515|NCT01982435|Secondary|Number of Participants With Angiographic Leakage|Number of participants with angiographic leakage in their study eye measured from baseline to months 3, 6 and 12 (i.e. presence of leakage).|3, 6 and 12 months|||Participants|||Count of Participants
652249|NCT02013050|Primary|Duration of Severe Oral Mucositis (SOM)|Duration of SOM was defined as the number of days from the onset of SOM until resolution of SOM. If the patient did not meet the requirements for resolution of SOM by the 1-month follow up visit, he/she was considered censored at the 1-month follow-up visit (or point of discontinuation of the study, if the patient had discontinued prior to the end of planned treatment). Patients who did not experience SOM were assigned a duration of 0.01. OM was evaluated using the published World Health Organization (WHO) OM grading scale that uses a scale of 0 to 4.|4 weeks after end of therapy|||days||95% Confidence Interval|Median
652250|NCT02012686|Primary|Numerical Rating Scale of Posterior Neck Pain 48 Hours After Thyroidectomy|numerical rating scale from 0 - 10. where 0 indicates no pain and 10 indicates the worst pain imaginable|48 hours after thyroidectomy|||scores on a scale||Full Range|Median
652251|NCT02012686|Primary|Numerical Rating Scale of Posterior Neck Pain 24 Hours After Thyroidectomy|numerical rating scale from 0 - 10. where 0 indicates no pain and 10 indicates the worst pain imaginable|24 hours after thyroidectomy|||scores on a scale||Inter-Quartile Range|Median
652252|NCT02012686|Primary|Numerical Rating Scale of Posterior Neck Pain 6 Hours After Thyroidectomy|numerical rating scale from 0 - 10. where 0 indicates no pain and 10 indicates the worst pain imaginable|6 hours after thyroidectomy|||scores on a scale||Inter-Quartile Range|Median
652253|NCT02012686|Primary|Numerical Rating Scale of Posterior Neck Pain 0.5 Hours After Thyroidectomy|numerical rating scale from 0 - 10. where 0 indicates no pain and 10 indicates the worst pain imaginable|0.5 hours after thyroidectomy|||scores on a scale||Full Range|Median
652254|NCT02012582|Primary|Safety and Tolerability of VAS203 in Patients With Moderate and Severe TBI|"Tolerability (good, satisfactory, sufficient, poor) of VAS203 in patients with moderate and severe TBI, as judged by the investigators at day 14.
Safety outcome measure description see safety section"|14 days|||participants|||Number
652255|NCT02012582|Post-Hoc|Extended Glasgow Outcome Score (eGOS)|"Scoring: Range from 1 (worst outcome) to 8 (good outcome). The patient´s overall rating is based on the lowest outcome category indicated on the scale.
Score Description
Dead
Vegetative State
Lower Severe Disability
Upper Severe Disability
Lower Moderate Disability
Upper Moderate Disability
Lower Good Recovery
Upper Good Recovery"|6 months after start of treatment|||units on a scale||Full Range|Median
652256|NCT02012582|Secondary|Therapy Intensity Level Score|"Therapy Intensity Level Score: Total Score calculated daily as the sum of all individual measures, range from 3 (good outcome) to 50 (worst outcome):
Scores:
0-2 Head elevation 0-8 Sedation 0-1 Paralysis 1-3 Hyperventilation 0-2 Increased Oxygenation 1-3 Cooling 0-2 Osmotherapy 0-3 CSF Drainage 0-1 Red Blood Cell Transfusion 1-3 Cerebral perfusion pressure 0-1 Surgery for mass lesion 0/5/10 none/unilateral/bilateral Decompressive Craniectomy 0/10 Laparatomy to treat intracranial hypertension due to abdominal hypertension"|Daily from day 1 to day 6|||units on a scale||Standard Deviation|Mean
652257|NCT02012582|Secondary|Duration (Number of Hours) of Cerebral Perfusion Pressure (CPP) < 60 mmHg|Duration (number of hours) of cerebral perfusion pressure (CPP) < 60 mmHg calculated from ICP and mean arterial blood pressure (MAP): CPP = MAP - ICP)|Hourly from start of infusion to 144 hours|||hours||Standard Deviation|Mean
652258|NCT02012582|Secondary|Duration (Number of Time-points) of Intracranial Pressure (ICP) > 20 mmHg||Hourly from start of infusion to 144 hours|||hours||Standard Deviation|Mean
652259|NCT02012452|Secondary|Percent Abstinent From Tobacco Use|biochemically confirmed abstinence from tobacco using self-report, cotinine, and CO breath samples|end of treatment|If participants did not come the follow-up visit they were assumed to be smokers. If they attended a later follow-up visit, tobacco use was retroactively assessed.||percent abstinent|||Number
652260|NCT02012452|Primary|Clinician Administered PTSD Scale|posttraumatic stress disorder clinician rated symptom ratings; scores range from 0-80 (with higher scores indicating greater PTSD severity)|end of 6 week PTSD treatment|||units on a scale||Standard Deviation|Mean
652261|NCT02012218|Primary|Mean Change From Baseline to Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|The MADRS was used as the primary efficacy assessment of level of depression. The MADRS was administered using the Structured Interview Guide for the MADRS. Detailed instructions were provided.The MADRS consists of 10 items each, with 7 defined grades of severity (ie, 0 to 6, with 0 being the “best” rating and 6 being the “worst” rating). The MADRS total score is the sum of ratings for all 10 items; therefore, possible total scores range from 0 to 60. The MADRS total score least squares (LS) mean changes from baseline to Week 6 is mentioned below.|Baseline and Week 6|All participants who took at least one dose of brexpiprazole and who had a valid baseline assessment and at least one valid post-baseline efficacy assessment.||Units on a scale||Standard Error|Least Squares Mean
652262|NCT02011893|Secondary|Test for Superiority of Overall Daily Visual Analog Scale (VAS) Score With Burst Stimulation|Differences for average daily overall pain using the Visual Analog Scale (VAS) pain diary between Burst and Tonic Stimulation to evaluate for superiority of Burst Stimulation. Differences for average daily overall pain using the Visual Analog Scale (VAS) pain diary between Burst and Tonic Stimulation. Visual Analog Scale (VAS) scores were averaged using a 7 day diary where the subject rates his/her pain on a horizontal line, 100mm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher level of pain.|Over 7 days after 3 months of treatment of burst or tonic stimulation|All subjects randomized were analyzed for this outcome measure. Statistical measures were used to impute Visual Analog Scale (VAS) scores according the study Statistical Analysis Plan (SAP) if data was not available.||mm||Standard Deviation|Mean
652263|NCT02011893|Secondary|Percentage of Paresthesia Coverage|Paresthesia mapping (percentage of paresthesia coverage) analyzed to demonstrate the differences between Burst and Tonic Stimulation. Data is presented as areas of paresthesia reported while utilizing either Burst or Tonic Stimulation as a percentage of the total number of areas possible.|During in-office visit after 3 months of treatment while utilizing burst or tonic stimulation|There were 73 subjects in whom paresthesia coverage data at both the 12 and 24 week visits were available and included in the analysis. The remaining 23 subjects were excluded due to questionnaire completion errors at the time of data collection.||Percentage of paresthesia areas||Standard Deviation|Mean
652356|NCT02009722|Secondary|Side Effects: Sedation|Patients will be evaluated by a member of the study team at 6, 12, and 24 hours after spinal administration. The presence of sedation will be graded by the Richmond Agitation Sedation Scale. Patients with a score of (-)2 or lower on the Richmond were classified as being positive for sedation.|6, 12, and 24 hours after spinal administration|||participants|||Number
652264|NCT02011893|Secondary|Number of Subjects With Response as Measured by Overall Daily Visual Analog Scale (VAS)|Number of subjects responding to Burst and Tonic Stimulation defined as 30% or greater decrease in overall Visual Analog Scale (VAS) score from baseline. Visual Analog Scale (VAS) scores were averaged using a 7 day diary where the subject rates his/her pain on a horizontal line, 100mm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher level of pain.|Over 7 days at baseline and after 3 months of treatment of burst or tonic stimulation|All subjects randomized were analyzed for this outcome measure. Statistical measures were used to impute Visual Analog Scale (VAS) scores according the study Statistical Analysis Plan (SAP) if data was not available.||participants|||Number
652265|NCT02011893|Primary|Visual Analog Scale (VAS) Pain Diary Scores for Average Overall Pain|Differences for average daily overall pain using the Visual Analog Scale (VAS) pain diary between Burst and Tonic Stimulation. Visual Analog Scale (VAS) scores were averaged using a 7 day diary where the subject rates his/her pain on a horizontal line, from 0 mm to 100mm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher level of pain.|Over 7 days after 3 months of treatment of burst or tonic stimulation|All subjects randomized were analyzed for this outcome measure. Statistical measures were used to impute Visual Analog Scale (VAS) scores according the study Statistical Analysis Plan (SAP) if data was not available.||mm||Standard Deviation|Mean
652266|NCT02011516|Primary|Urine Drug Screen|Change from positive to negative over the 12 weeks of a medication regimen|study weeks 1-12|||Participants|||Count of Participants
652267|NCT02011490|Primary|Geometric Mean Apparent First-order Terminal Elimination Rate Constant (λz) Following a Single IV Dose of Sugammadex|Plasma samples for determination of sugammadex pharmacokinetic parameters were obtained pre-dose and at specified post-dose time points. λz was calculated by regression of the terminal log-linear portion of the plasma concentration-time profile.|For participants with: normal renal function - up to 48 hours post-dose (Part 1 + Part 2); moderate renal insufficiency - up to Day 28 (Part 1) or Day 10 (Part 2); severe renal insufficiency - up to Day 35 (Part 1) or Day 14 (Part 2)|Pharmacokinetic analysis was performed only for Part 2 data for participants in Part 2. Analysis was not conducted for Part 1, as review of drug concentration data, and dosing issues noted at investigative sites, indicated that in some participants, doses may not have been administered directly into vein, and likely infiltrated surrounding tissue.||1/hr||Geometric Coefficient of Variation|Geometric Mean
652268|NCT02011490|Primary|Geometric Mean Effective Half-life (t1/2eff) Following a Single IV Dose of Sugammadex|Plasma samples for determination of sugammadex pharmacokinetic parameters were obtained pre-dose and at specified post-dose time points. t½eff was calculated as ln(2)*MRT.|For participants with: normal renal function - up to 48 hours post-dose (Part 1 + Part 2); moderate renal insufficiency - up to Day 28 (Part 1) or Day 10 (Part 2); severe renal insufficiency - up to Day 35 (Part 1) or Day 14 (Part 2)|Pharmacokinetic analysis was performed only for Part 2 data for participants in Part 2. Analysis was not conducted for Part 1, as review of drug concentration data, and dosing issues noted at investigative sites, indicated that in some participants, doses may not have been administered directly into vein, and likely infiltrated surrounding tissue.||hr||Geometric Coefficient of Variation|Geometric Mean
652269|NCT02011490|Primary|Geometric Mean Apparent First-order Terminal Elimination Half-life (t1/2) Following a Single IV Dose of Sugammadex|Plasma samples for determination of sugammadex pharmacokinetic parameters were obtained pre-dose and at specified post-dose time points. Elimination t1/2 is the time it takes for the concentration of the drug in the body to decrease by half during the elimination phase, calculated as the natural log of 2 (ln[2])/λz.|For participants with: normal renal function - up to 48 hours post-dose (Part 1 + Part 2); moderate renal insufficiency - up to Day 28 (Part 1) or Day 10 (Part 2); severe renal insufficiency - up to Day 35 (Part 1) or Day 14 (Part 2)|Pharmacokinetic analysis was performed only for Part 2 data for participants in Part 2. Analysis was not conducted for Part 1, as review of drug concentration data, and dosing issues noted at investigative sites, indicated that in some participants, doses may not have been administered directly into vein, and likely infiltrated surrounding tissue.||hr||Geometric Coefficient of Variation|Geometric Mean
652270|NCT02011490|Primary|Median Time of the Last Measurable Plasma Concentration (Tlast) Following a Single IV Dose of Sugammadex|Plasma samples for determination of sugammadex pharmacokinetic parameters were obtained pre-dose and at specified post-dose time points. Tlast was determined from the observed plasma concentration-time data.|For participants with: normal renal function - up to 48 hours post-dose (Part 1 + Part 2); moderate renal insufficiency - up to Day 28 (Part 1) or Day 10 (Part 2); severe renal insufficiency - up to Day 35 (Part 1) or Day 14 (Part 2)|Pharmacokinetic analysis was performed only for Part 2 data for participants in Part 2. Analysis was not conducted for Part 1, as review of drug concentration data, and dosing issues noted at investigative sites, indicated that in some participants, doses may not have been administered directly into vein, and likely infiltrated surrounding tissue.||hr||Full Range|Median
652271|NCT02011490|Primary|Median Time to Maximum Observed Plasma Concentration (Tmax) Following a Single IV Dose of Sugammadex|Plasma samples for determination of sugammadex pharmacokinetic parameters were obtained pre-dose and at specified post-dose time points. Tmax was determined from the observed plasma concentration-time data.|For participants with: normal renal function - up to 48 hours post-dose (Part 1 + Part 2); moderate renal insufficiency - up to Day 28 (Part 1) or Day 10 (Part 2); severe renal insufficiency - up to Day 35 (Part 1) or Day 14 (Part 2)|Pharmacokinetic analysis was performed only for Part 2 data for participants in Part 2. Analysis was not conducted for Part 1, as review of drug concentration data, and dosing issues noted at investigative sites, indicated that in some participants, doses may not have been administered directly into vein, and likely infiltrated surrounding tissue.||hr||Full Range|Median
652297|NCT02010684|Secondary|Change From Baseline in EQ-5D at 6 Months|"The EQ-5D measures general quality of life. The index score is based on 5 questions about mobility, self-care, pain, usual activities, and psychological status. The EuroQol Group provides a U.S. preference-weighted algorithm to calculate the index scores. A score of 1 indicates no problems while a score of -0.11 indicates severe problems.
The scale score is based on a visual analog of a thermostat, where 0 represents worst imaginable health and 100 represents best imaginable health. Patients mark a tick for where they feel their health is on that scale."|Baseline and 6 months|||units on a scale||Standard Deviation|Mean
652298|NCT02010684|Secondary|Change From Baseline in Low Density Lipoprotein-C at 6 Months||Baseline and 6 months|||mg/dL||Standard Deviation|Mean
652272|NCT02011490|Primary|Geometric Mean Apparent Volume of Distribution Estimated at Steady-state (Vss) Following a Single IV Dose of Sugammadex|Plasma samples for determination of sugammadex pharmacokinetic parameters were obtained pre-dose and at specified post-dose time points. Vss is the theoretical volume that the total amount of administered drug would have to occupy (if it were uniformly distributed), to provide the same concentration as it is in blood plasma at steady state, calculated as CL*MRT.|For participants with: normal renal function - up to 48 hours post-dose (Part 1 + Part 2); moderate renal insufficiency - up to Day 28 (Part 1) or Day 10 (Part 2); severe renal insufficiency - up to Day 35 (Part 1) or Day 14 (Part 2)|Pharmacokinetic analysis was performed only for Part 2 data for participants in Part 2. Analysis was not conducted for Part 1, as review of drug concentration data, and dosing issues noted at investigative sites, indicated that in some participants, doses may not have been administered directly into vein, and likely infiltrated surrounding tissue.||L||Geometric Coefficient of Variation|Geometric Mean
652273|NCT02011490|Primary|Geometric Mean of Mean Residence Time (MRT) of Unchanged Drug in the Systemic Circulation Following a Single IV Dose of Sugammadex|Plasma samples for determination of sugammadex pharmacokinetic parameters were obtained pre-dose and at specified post-dose time points. MRT is defined as the mean duration of time a drug molecule is present in the systemic circulation.|For participants with: normal renal function - up to 48 hours post-dose (Part 1 + Part 2); moderate renal insufficiency - up to Day 28 (Part 1) or Day 10 (Part 2); severe renal insufficiency - up to Day 35 (Part 1) or Day 14 (Part 2)|Pharmacokinetic analysis was performed only for Part 2 data for participants in Part 2. Analysis was not conducted for Part 1, as review of drug concentration data, and dosing issues noted at investigative sites, indicated that in some participants, doses may not have been administered directly into vein, and likely infiltrated surrounding tissue.||hr||Geometric Coefficient of Variation|Geometric Mean
652274|NCT02011490|Primary|Geometric Mean Volume of Distribution During the Terminal Elimination Phase (Vz) Following a Single IV Dose of Sugammadex|Plasma samples for determination of sugammadex pharmacokinetic parameters were obtained pre-dose and at specified post-dose time points. Vz was calculated as Dose/(AUC0-∞*λz).|For participants with: normal renal function - up to 48 hours post-dose (Part 1 + Part 2); moderate renal insufficiency - up to Day 28 (Part 1) or Day 10 (Part 2); severe renal insufficiency - up to Day 35 (Part 1) or Day 14 (Part 2)|Pharmacokinetic analysis was performed only for Part 2 data for participants in Part 2. Analysis was not conducted for Part 1, as review of drug concentration data, and dosing issues noted at investigative sites, indicated that in some participants, doses may not have been administered directly into vein, and likely infiltrated surrounding tissue.||L||Geometric Coefficient of Variation|Geometric Mean
652275|NCT02011490|Primary|Geometric Mean Total Clearance (CL) Following a Single IV Dose of Sugammadex|Plasma samples for determination of sugammadex pharmacokinetic parameters were obtained pre-dose and at specified post-dose time points. CL is a quantitative measure of the rate at which a drug substance is removed from the body, calculated as Dose/AUC0-∞.|For participants with: normal renal function - up to 48 hours post-dose (Part 1 + Part 2); moderate renal insufficiency - up to Day 28 (Part 1) or Day 10 (Part 2); severe renal insufficiency - up to Day 35 (Part 1) or Day 14 (Part 2)|Pharmacokinetic analysis was performed only for Part 2 data for participants in Part 2. Analysis was not conducted for Part 1, as review of drug concentration data, and dosing issues noted at investigative sites, indicated that in some participants, doses may not have been administered directly into vein, and likely infiltrated surrounding tissue.||L/hr||Geometric Coefficient of Variation|Geometric Mean
652276|NCT02011490|Primary|Geometric Mean Percent of AUC0-∞ That Was Extrapolated (AUC%Extrap) Following a Single IV Dose of Sugammadex|Plasma samples for determination of sugammadex pharmacokinetic parameters were obtained pre-dose and at specified post-dose time points. AUC%extrap represents the percentage of the AUC0-∞ obtained by extrapolation, calculated as (1 - [AUC0-last/AUC0-∞]) multiplied by 100.|For participants with: normal renal function - up to 48 hours post-dose (Part 1 + Part 2); moderate renal insufficiency - up to Day 28 (Part 1) or Day 10 (Part 2); severe renal insufficiency - up to Day 35 (Part 1) or Day 14 (Part 2)|Pharmacokinetic analysis was performed only for Part 2 data for participants in Part 2. Analysis was not conducted for Part 1, as review of drug concentration data, and dosing issues noted at investigative sites, indicated that in some participants, doses may not have been administered directly into vein, and likely infiltrated surrounding tissue.||Percent extrapolated||Geometric Coefficient of Variation|Geometric Mean
652277|NCT02011490|Primary|Geometric Least Squares Mean Maximum Observed Plasma Concentration (Cmax) Following a Single IV Dose of Sugammadex|Plasma samples for determination of sugammadex pharmacokinetic parameters were obtained pre-dose and at specified post-dose time points. Cmax was determined from the observed plasma concentration-time data. The reported least squares mean is the geometric least squares mean, which is the back-transformed least squares mean from the ANOVA linear fixed-effect model performed on natural log-transformed values of Cmax. This calculation also provides the associated 95% confidence interval.|For participants with: normal renal function - up to 48 hours post-dose (Part 1 + Part 2); moderate renal insufficiency - up to Day 28 (Part 1) or Day 10 (Part 2); severe renal insufficiency - up to Day 35 (Part 1) or Day 14 (Part 2)|Pharmacokinetic analysis was performed only for Part 2 data for participants in Part 2. Analysis was not conducted for Part 1, as review of drug concentration data, and dosing issues noted at investigative sites, indicated that in some participants, doses may not have been administered directly into vein, and likely infiltrated surrounding tissue.||ug/mL||95% Confidence Interval|Least Squares Mean
652278|NCT02011490|Primary|Geometric Least Squares Mean Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC0-last) Following a Single IV Dose of Sugammadex|Plasma samples for determination of sugammadex pharmacokinetic parameters were obtained pre-dose and at specified post-dose time points. AUC0-last was determined by trapezoidal method. The reported least squares mean is the geometric least squares mean, which is the back-transformed least squares mean from the ANOVA linear fixed-effect model performed on natural log-transformed values of AUC0-last. This calculation also provides the associated 95% confidence interval.|For participants with: normal renal function - up to 48 hours post-dose (Part 1 + Part 2); moderate renal insufficiency - up to Day 28 (Part 1) or Day 10 (Part 2); severe renal insufficiency - up to Day 35 (Part 1) or Day 14 (Part 2)|Pharmacokinetic analysis was performed only for Part 2 data for participants in Part 2. Analysis was not conducted for Part 1, as review of drug concentration data, and dosing issues noted at investigative sites, indicated that in some participants, doses may not have been administered directly into vein, and likely infiltrated surrounding tissue.||ug*hr/mL||95% Confidence Interval|Least Squares Mean
652279|NCT02011490|Primary|Geometric Least Squares Mean Area Under the Plasma Drug Concentration-time Curve From Time Zero to Infinity (AUC0-∞) Following a Single IV Dose of Sugammadex|Plasma samples for determination of sugammadex pharmacokinetic parameters were obtained pre-dose and at specified post-dose time points. AUC0-∞ was calculated as the sum of the AUC to the last time point with a detectable plasma concentration (AUC0-last, determined by trapezoidal method) and the extrapolated area given by Cest,last/λz, where Cest,last is the estimated concentration corresponding to the time of the last measurable concentration and λz is the apparent first-order terminal elimination rate constant. For each subject, λz was calculated by regression of the terminal log-linear portion of the plasma concentration-time profile. The reported least squares mean is the geometric least squares mean, which is the back-transformed least squares mean from the analysis of variance (ANOVA) linear fixed-effect model performed on natural log-transformed values of AUC0-∞. This calculation also provides the associated 95% confidence interval.|For participants with: normal renal function - up to 48 hours post-dose (Part 1 + Part 2); moderate renal insufficiency - up to Day 28 (Part 1) or Day 10 (Part 2); severe renal insufficiency - up to Day 35 (Part 1) or Day 14 (Part 2)|Pharmacokinetic analysis was performed only for Part 2 data for participants in Part 2. Analysis was not conducted for Part 1, as review of drug concentration data, and dosing issues noted at investigative sites, indicated that in some participants, doses may not have been administered directly into vein, and likely infiltrated surrounding tissue.||ug*hr/mL||95% Confidence Interval|Least Squares Mean
652280|NCT02011464|Other Pre-specified|Side Effects of Analgesia|Secondary end points will include the incidence of opioid related side effects (nausea, vomiting, pruritis, constipation, respiratory depression, and hypoxia) and hemodynamic perturbations related to pain|72 hours post-operative|Number of patients with opioid related side effects (nausea, vomiting, pruritis, constipation, respiratory depression, and hypoxia) and hemodynamic perturbations related to pain||participants|||Number
652281|NCT02011464|Secondary|Post-operative Narcotic Use|Average postoperative narcotics administered in total milligrams of morphine equivalents|72 hours post-operative|||mgs||Standard Deviation|Mean
652282|NCT02011464|Primary|Subjective Pain|Subject reported post-surgical pain using the visual analog scale (VAS) during the hospital stay and after discharge. This is a 0-10 point numeric rating scale where 0 is no pain and 10 is the highest level of pain.|72 hours post-operative|||units on a scale||Standard Deviation|Mean
652283|NCT02011113|Secondary|Number of Participants With Adverse Events|Relation to study drug was assessed by the Investigator as either suspected or not suspected. Counts represent the suspected relationship. Severity was assessed using National Cancer Institute Common Toxicity Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0): 1= Mild 2= Moderate 3= Severe 4= Life-threatening and 5= Death related to AE. Serious AEs (SAEs) were those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above. Treatment Emergent Adverse Event (TEAE) was defined as any AE occurring on or after the first treatment of the study medication and within 28 days after the last dose.|From first dose of study drug to final data cut-off date of 25 Sept 2015, maximum duration on treatment was 80.9 weeks|Safety population includes all participants who took at least one dose of study medication.||participants|||Number
652284|NCT02011113|Secondary|Kaplan-Meier Estimates of PFS (Later Cut-off Date)|PFS was calculated as the time from the first dosing to the first documented progressive disease, as determined by the investigators based on the IMWG Uniform Response criteria, or death, whichever occurred earlier|From the first dose until the final data cut-off date of 25 September 2015; maximum duration on treatment was 80.9 weeks|Efficacy Evaluable Population includes all participants who met eligibility criteria, took at least one dose of study medication, and had a baseline and a post-baseline efficacy assessment.||weeks||95% Confidence Interval|Median
652285|NCT02011113|Secondary|Kaplan-Meier Estimates of Progression-free Survival (PFS)|PFS was calculated as the time from the first dosing to the first documented progressive disease, as determined by the investigators based on the IMWG Uniform Response criteria, or death, whichever occurred earlier|From the first dose until the data cut-off date of 03 September 2014; maximum time on treatment was 36.0 weeks|Efficacy Evaluable Population includes all participants who met eligibility criteria, took at least one dose of study medication, and had a baseline and a post-baseline efficacy assessment.||weeks||95% Confidence Interval|Median
652286|NCT02011113|Secondary|Kaplan-Meier Estimates of Duration of Response (Later Cut-off Date)|Duration of response (calculated for responders only) was defined as time from the initial documented response (partial response or better) to confirmed disease progression, based on IMWG criteria.|From the first dose until the final data cut-off date of 25 September 2015; maximum duration on treatment was 80.9 weeks|Efficacy Evaluable Population includes all participants who met eligibility criteria, took at least one dose of study medication, and had a baseline and a post-baseline efficacy assessment.||weeks||95% Confidence Interval|Median
652287|NCT02011113|Secondary|Kaplan-Meier Estimates of Duration of Response|Duration of response (calculated for responders only) was defined as time from the initial documented response (partial response or better) to confirmed disease progression, based on IMWG criteria.|From first dose until the data cut-off date of 03 September 2014; maximum time for follow-up was 36 weeks|Duration of Response was not analyzed as there was insufficient data available at Cycle 2, Day 1 of study treatment. There was limited data evaluated and data were not analyzed.|||||
652288|NCT02011113|Secondary|Time to Response (Later Cut-off Date)|Time to response was calculated as the time from the first dose to the initial documented response (partial response or better) based on IMWG criteria. SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. If present at baseline a ≥ 50% reduction in size of soft tissue plasmacytomas is also required.|From the first dose until the final data cut-off date of 25 September 2015; maximum duration on treatment was 80.9 weeks|Included participants with at least a PR or better based on Assessment using IMWG criteria; EPP includes all participants who meet eligibility criteria, take at least one dose of study medication, and have a baseline and a post-baseline efficacy assessment.||weeks||Full Range|Median
652289|NCT02011113|Secondary|Myeloma Response Rate Based on European Group for Blood and Marrow Transplantation (EBMT) Criteria (Later Cut-off Date)|Myeloma response was defined as a best overall response of complete response (CR) or partial response (PR) CR is defined as: - Absence of original monoclonal paraprotein in serum and urine by immunofixation maintained at least 42 days. - <5% plasma cell in bone marrow aspirate and on bone marrow biopsy, if performed. - No increase in size or number of lytic bone lesions. - Disappearance of soft tissue plasmacytomas. PR requires all of the following: - ≥ 50% reduction in level of serum monoclonal paraprotein, maintained at least 42 days. - Reduction in 24-hour urinary light chain extraction by ≥ 90% or to < 200 mg, maintained at least 42 days. - For patients with non-secretory myeloma, ≥ 50% reduction in plasma cells in bone marrow aspirate and on biopsy, if performed, for at least 42 days. - ≥ 50% reduction in the size of soft tissue plasmacytomas. - No increase in size or number of lytic bone lesions.|From the first dose until the final data cut-off date of 25 September 2015; maximum duration on treatment was 80.9 weeks|EEP includes all participants who met eligibility criteria, took at least one dose of study medication, and had a baseline and a post-baseline efficacy assessment.||percentage of participants responding||95% Confidence Interval|Number
652290|NCT02011113|Primary|Myeloma Response Rate Based on the International Myeloma Working Group (IMWG) Uniform Response Criteria (Later Cut-off Date)|Myeloma response was defined as a best overall response of stringent complete response (SCR), complete response (CR), very good partial response (VGPR) or partial response (PR) SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. In addition to the above, if present at baseline a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required.|From the first dose until the final data cut-off date of 25 September 2015; maximum duration on treatment was 80.9 weeks|Efficacy Evaluable Population (EEP) includes all participants who met eligibility criteria, took at least one dose of study medication, and had a baseline and a post-baseline efficacy assessment.||percentage of participants responding||95% Confidence Interval|Number
652291|NCT02011113|Secondary|Time to Response|Time to response was calculated as the time from the first dose to the initial documented response (partial response or better) based on IMWG criteria. SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. If present at baseline a ≥ 50% reduction in size of soft tissue plasmacytomas is also required.|From the first dose until the data cut-off date of 03 September 2014. Maximum time on follow-up was 36.0 weeks.|Included participants with at least a PR or better based on Assessment using IMWG criteria.||weeks||Full Range|Median
652292|NCT02011113|Secondary|Myeloma Response Rate Based on European Group for Blood and Marrow Transplantation (EBMT) Criteria|Myeloma response was defined as a best overall response of complete response (CR) or partial response (PR) CR is defined as: - Absence of original monoclonal paraprotein in serum and urine by immunofixation maintained at least 42 days. - <5% plasma cell in bone marrow aspirate and on bone marrow biopsy, if performed. - No increase in size or number of lytic bone lesions. - Disappearance of soft tissue plasmacytomas. PR requires all of the following: - ≥ 50% reduction in level of serum monoclonal paraprotein, maintained at least 42 days. - Reduction in 24-hour urinary light chain extraction by ≥ 90% or to < 200 mg, maintained at least 42 days. - For patients with non-secretory myeloma, ≥ 50% reduction in plasma cells in bone marrow aspirate and on biopsy, if performed, for at least 42 days. - ≥ 50% reduction in the size of soft tissue plasmacytomas. - No increase in size or number of lytic bone lesions.|From first dose until the data cut-off date of 03 September 2014; maximum time in follow-up was 36.0 weeks|Efficacy Evaluable Population includes all participants who met eligibility criteria, took at least one dose of study medication, and had a baseline and a post-baseline efficacy assessment.||percentage of participants responding||95% Confidence Interval|Number
652293|NCT02011113|Primary|Myeloma Response Rate Based on the International Myeloma Working Group (IMWG) Uniform Response Criteria|Myeloma response was defined as a best overall response of stringent complete response (SCR), complete response (CR), very good partial response (VGPR) or partial response (PR) SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. In addition to the above, if present at baseline a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required.|From the first dose until the data cut-off date of 03 Sept 2014; Maximum time in follow-up was 36.0 weeks.|Efficacy Evaluable Population includes all participants who met eligibility criteria, took at least one dose of study medication, and had a baseline and a post-baseline efficacy assessment.||percentage of participants responding||95% Confidence Interval|Number
652294|NCT02010996|Primary|Early Complications of Vascular Zone||2 weeks|||participants|||Number
652295|NCT02010684|Secondary|Change From Baseline in Self-Efficacy (Diabetes Empowerment Scale) at 6 Months|The Diabetes Empowerment Scale Short Form (DES-SF) measures diabetes-related psychosocial self-efficacy. The questionnaire presents 8 statements on self-efficacy where participants rate how strongly they agree. The answers are summed to create a score where higher scores indicate more empowerment. The score range is 0 to 8.|Baseline and 6 months|||units on a scale||Standard Deviation|Mean
652296|NCT02010684|Secondary|Change From Baseline in Yale Physical Activity Scale - Index Summary Score at 6 Months|The Yale Physical Activity Scale measures physical function and activities of daily living. Five activity indices (vigorous activity, leisurely walking, moving, standing and sitting) are calculated by multiplying the frequency of activity with the duration and a weighted factor. The 5 indices are then summed to create an index summary. Higher scores indicate more activity. The minimum and maximum scores are 0 and 142.|Baseline and 6 months|||units on a scale||Standard Deviation|Mean
652300|NCT02010684|Primary|Change From Baseline in Depression Measures at 6 Months|"The Geriatric Depression Scale (GDS) measures depression in older adults. The short form we used consists of 15 yes or no questions. The scale range is 0 to 15, where higher scores indicate greater severity of depression.
The Patient Health Questionnaire-9 (PHQ-9) measures depression in patients. The questionnaire consists of 9 questions where patients self report how frequently they have depression symptoms over the past two weeks. The scale ranges is 0 to 27 where higher scores indicate greater severity of depression."|Baseline and 6 months|||units on a scale||Standard Deviation|Mean
652301|NCT02010684|Primary|Change From Baseline in Hemoglobin A1c at 6 Months|Hemoglobin A1c (HbA1c) measures glycemic control over the past three months. HbA1c was measured by a blood draw and laboratory test.|Baseline and 6 months|||percentage of glycated hemoglobin||Standard Deviation|Mean
652302|NCT02010632|Secondary|Pharmacokinetic Profiles: Time to Maximum Plasma Concentration (Tmax)||Blood collection at 0 (before dosing), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7||||||
652303|NCT02010632|Secondary|Pharmacokinetic Profiles: The Maximum Plasma Concentration (Cmax)||Blood collection at 0 (before dosing), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7||||||
652304|NCT02010632|Secondary|Pharmacokinetic Profiles: Area Under the Concentration-Time Curve (AUC 0-24)||Blood collection at 0 (before dosing), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7||||||
652305|NCT02010632|Primary|Pharmacodynamic Effect: The Platelet Inhibition Effect of Clopidogrel at the Various Times on Day 7 (0-24 Hours) (at Steady State)||Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7|||percent inhibition*hour||Standard Deviation|Mean
652306|NCT02010255|Secondary|Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in CPT Score|CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15 (maximum score for entry into the study was 12); higher scores/increased scores indicate greater severity of disease. Groups are arranged by cohort, then by duration of treatment, then by CPT class at baseline.|Baseline to Posttreatment Week 4|Full Analysis Set. Cirrhotic participants were analyzed if they had measurements at both baseline and Posttreatment Week 4. Only groups with cirrhotic participants are presented.||percentage of participants|||Number
652307|NCT02010255|Secondary|Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in MELD Score|Model for End-Stage Liver Disease (MELD) scores are used to assess prognosis and suitability for liver transplantation. Scores can range from 6 to 40; higher scores/increased scores indicate greater severity of disease.|Baseline to Posttreatment Week 4|Full Analysis Set. Participants with cirrhosis were analyzed if they had measurements at both baseline and Posttreatment Week 4. Only groups with cirrhotic participants are presented.||percentage of participants|||Number
652308|NCT02010255|Secondary|HCV RNA Levels and Change From Baseline at Week 12||Baseline; Week 12|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
652309|NCT02010255|Secondary|HCV RNA Levels and Change From Baseline at Week 8||Baseline; Week 8|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
652310|NCT02010255|Secondary|HCV RNA Levels and Change From Baseline at Week 6||Baseline; Week 6|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
652311|NCT02010255|Secondary|HCV RNA Levels and Change From Baseline at Week 4||Baseline; Week 4|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
652312|NCT02010255|Secondary|HCV RNA Levels and Change From Baseline at Week 2||Baseline; Week 2|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
652313|NCT02010255|Secondary|HCV RNA Levels and Change From Baseline at Week 1||Baseline; Week 1|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
652314|NCT02010255|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 24||Week 24|Participants in the Full Analysis Set who were randomized to a 24-week treatment group and had available data were analyzed. 12-week treatment groups (did not collect data past Week 12) are not presented in this table.||Percentage of participants|||Number
652315|NCT02010255|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 20||Week 20|Participants in the Full Analysis Set who were randomized to a 24-week treatment group and had available data were analyzed. 12-week treatment groups (did not collect data past Week 12) are not presented in this table.||Percentage of participants|||Number
652316|NCT02010255|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 16||Week 16|Participants in the Full Analysis Set who were randomized to a 24-week treatment group and had available data were analyzed. 12-week treatment groups (did not collect data past Week 12) are not presented in this table.||Percentage of participants|||Number
652317|NCT02010255|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 12||Week 12|Participants in the Full Analysis Set with available data were analyzed.||Percentage of participants|||Number
652318|NCT02010255|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 8||Week 8|Participants in the Full Analysis Set with available data were analyzed.||Percentage of participants|||Number
652319|NCT02010255|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 6||Week 6|Participants in the Full Analysis Set with available data were analyzed.||Percentage of participants|||Number
652320|NCT02010255|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 4||Week 4|Participants in the Full Analysis Set with available data were analyzed.||Percentage of participants|||Number
652321|NCT02010255|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 2||Week 2|Full Analysis Set||Percentage of participants|||Number
652322|NCT02010255|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 1||Week 1|Full Analysis Set||Percentage of participants|||Number
652323|NCT02010255|Secondary|Percentage of Participants With Posttransplant Virologic Response (pTVR) at Posttransplant Week 12|pTVR was defined as HCV RNA < LLOQ at Week 12 after transplant.|Posttreatment Week 12|Participants who had a liver transplant while on study were analyzed if their last observed HCV RNA measurement prior to transplant was < LLOQ. Participants who received a transplant from an HCV-infected donor were excluded from analysis.||Percentage of participants|||Number
652324|NCT02010255|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as:
On-treatment virologic failure:
Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ on 2 consecutive measurements while on treatment), or
Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment)
Virologic relapse:
Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 24|Full Analysis Set. Participants were excluded from the analysis if they received a liver transplant while on study (with HCV RNA <LLOQ at transplant) prior to lower bound of Posttreatment Week 12 visit window.||Percentage of participants|||Number
652325|NCT02010255|Secondary|Percentage of Participants With SVR 24 Weeks After Discontinuation of Therapy (SVR24)|SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.|Posttreatment Week 24|Full Analysis Set. Participants in Cohort A and 1 participant in Cohort B who received a liver transplant prior to the lower bound of the Posttreatment Week 24 visit were not included in the analysis.||Percentage of participants|||Number
652326|NCT02010255|Secondary|Percentage of Participants With SVR 8 Weeks After Discontinuation of Therapy (SVR8)|SVR8 was defined as HCV RNA < LLOQ at 8 weeks after stopping study treatment.|Posttreatment Week 8|Full Analysis Set. Participants in Cohort A who received a liver transplant prior to the lower bound of the Posttreatment Week 8 visit were not included in the analysis.||Percentage of participants|||Number
652327|NCT02010255|Secondary|Percentage of Participants With SVR 4 Weeks After Discontinuation of Therapy (SVR4)|SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.|Posttreatment Week 4|Full Analysis Set. Participants in Cohort A who received a liver transplant prior to the lower bound of the Posttreatment Week 4 visit were not included in the analysis.||Percentage of participants|||Number
652328|NCT02010255|Secondary|Percentage of Participants With SVR 2 Weeks After Discontinuation of Therapy (SVR2)|SVR2 was defined as HCV RNA < LLOQ at 2 weeks after stopping study treatment.|Posttreatment Week 2|Full Analysis Set. Participants in Cohort A who received a liver transplant prior to the lower bound of the Posttreatment Week 2 visit were not included in the analysis.||percentage of participants|||Number
652329|NCT02010255|Primary|Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event||Up to 24 weeks|Safety Analysis Set: participants who were randomized and received at least one dose of study drug||percentage of participants|||Number
652330|NCT02010255|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants who were randomized and received at least one dose of study drug. Participants in Cohort A who received a liver transplant prior to the lower bound of the Posttreatment Week 12 visit were not included in the analysis.||percentage of participants|||Number
652331|NCT02010216|Primary|Safety: Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events. A SAE was any experience that suggested a significant hazard, contraindication, side effect or precaution that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant.|12 weeks|Safety population included all participants who received study drug.||participants|||Number
652332|NCT02010216|Primary|Percentage of Participants Achieving ACR20/50/70 Responses After the Third Infusion Categorized by Highest Response Achieved|American College of Rheumatology (ACR) ACR20, ACR50 or ACR70 response is defined as a ≥ 20% or 50% or 70% improvement (reduction) compared with Baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].|Baseline, Week 12|Intent-to-treat population included all participants.||percentage of participants|||Number
652333|NCT02010216|Primary|Change From Baseline in Disease Activity 28 (DAS28) Score|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement.|Baseline, Week 12|Intent-to-treat population included all participants.||score on a scale||Standard Deviation|Mean
652334|NCT02009982|Secondary|Incidence of Serious Adverse Events|The secondary endpoint for this study will be the incidence of serious adverse events related to the study procedure within the 12 month follow-up protocol|12 Months|No data was analyzed due to low enrollment.|||||
652335|NCT02009982|Primary|Syncope Recurrence Rate|The primary endpoint for the study is recurrence of syncope within the 12 month follow-up protocol|12 Months|No data was analyzed due to low enrollment.|||||
652357|NCT02009722|Secondary|Side Effects: Nausea|Patients will be evaluated by a member of the study team at 6 hours after spinal administration. Patients with moderate or severe nausea will be recorded.|6 hours after spinal|The number of patients at the most commonly used doses of IT medication (50, 75, 100 mcg for hydromorphone) and (100, 150 mcg) for morphine were used in analysis||participants|||Number
652358|NCT02009722|Secondary|Side Effects: Pruritus|Patients will be evaluated by a member of the study team at 6 hours after spinal administration. The number of patients with moderate or severe pruritus will be recorded.|6 hours after spinal administration|The number of patients at the most commonly used doses of IT medication (50, 75, 100 mcg for hydromorphone) and (100, 150 mcg) for morphine were used in analysis||participants|||Number
652336|NCT02009878|Secondary|Change From Baseline in Cumulative Urine Volume at 0-6 Hours, 0-12 Hours and 0-24 Hours.|Urine was collected for baseline comparison on Day 0 for the 24 hour prior to Day 1 dosing at intervals of 0 to 2, 2 to 4, 4, to 6, 6, to 8, 8, to 12, and 12 to 24 hours relative to Day 1 dosing time. Urine was collected on Day 1 at intervals of 0 to 2,2 to 4, 4 to 6, 6 to 8, 8 to 12, and 12 to 24 hours postdose. For the start of the urine collection on Day 0, a window of 15 to 40 minutes prior to the assigned dosing time was acceptable, with the 0 to 24 hour collection period on Day 1 starting 24 hours after the start time on Day 0. Participants were asked to void immediately prior to the end of the collection interval. The volume of individual voids were measured and recorded prior to refrigerating. All voids in a collection interval were pooled at the end of the collection interval, at which time the volume was determined, recorded and an aliquot taken for osmolality, sodium, potassium, and creatinine assessments.|2 days|PD dataset comprised of all participants who had taken 1 dose of study medication and had all observed measurements.||mL||Standard Deviation|Mean
652337|NCT02009878|Secondary|Change From Baseline in Fluid Balance (Fluid Intake Minus Urine Output) From 0-6 Hours, 0-12 Hours and 0-24 Hours.|Fluid intake was monitored on Day 0 (times relative to Day 1 dosing), and Day 1 at intervals of 0 to 6, 6 to 12, and 12 to 24 hours postdose. Fluid intake included fluid used for dosing (study medication and any concomitant medication); food items that included any significant amounts of water (e.g., Jello [including Gelatin and Jelly dessert] and soup) was added to the total fluid intake. Urine was collected for baseline comparison on Day 0 for the 24 hour prior to Day 1 dosing at intervals of 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12 hours, and 12 to 24 hours relative to the Day 1 dosing time. Fluid balance was determined as fluid intake minus urine output.|2 days|PD dataset comprised of all participants who had taken 1 dose of study medication and had all observed measurements.||mL||Standard Deviation|Mean
652338|NCT02009878|Secondary|Change From Baseline in Fluid Intake From 0-6 Hours, 0-12 Hours and 0-24 Hours|Fluid intake was monitored on Day 0 (times relative to Day 1 dosing), and Day 1 at intervals of 0 to 6, 6 to 12, and 12 to 24 hours postdose. Fluid intake included fluid used for dosing (study medication and any concomitant medication); food items that included any significant amounts of water (e.g., Jello [including Gelatin and Jelly dessert] and soup) was added to the total fluid intake. Samples were taken on Day 0 (baseline) at the corresponding Day 1 predose time and 12 hours postdose time; and on Day 1 at predose and at 2, 4, 6, 8, 12, and 24 hours postdose.|Baseline and Day 2|PD dataset comprised of all participants who had taken 1 dose of study medication and had all observed measurements.||mL||Standard Deviation|Mean
652339|NCT02009878|Primary|Time of Maximal Increase From Baseline in Serum Sodium Concentration Following Tolvaptan Administration.|Time of maximal increase in serum sodium is summarized in the table below by tolvaptan dose. Samples were taken on Day 0 (baseline) at the corresponding Day 1 predose time and 12 hours postdose time; and on Day 1 at predose and at 2, 4, 6, 8, 12, and 24 hours postdose.|Baseline to Day 2|PD dataset comprised of all participants who had taken 1 dose of study medication and had all observed measurements.||hours||Full Range|Median
652340|NCT02009878|Secondary|Change From Baseline in Serum Sodium Concentrations|Samples were taken on Day 0 (baseline) at the corresponding Day 1 predose time and 12 hours postdose time; and on Day 1 at predose and at 2, 4, 6, 8, 12, and 24 hours postdose.|Baseline and Day 2|PD dataset comprised of all participants who had taken 1 dose of study medication and had all observed measurements.||mmol/L||Standard Deviation|Mean
652341|NCT02009878|Secondary|AUC Infinity (Area Under the Concentration-time Curve From Time Zero to Infinity) for Tolvaptan in Plasma|Blood samples for determination of plasma concentrations of tolvaptan were collected predose and 1, 2, 3, 4, 8, 12, 16, and 24 hours postdose on Day 1 or at ET. If an indwelling catheter was utilized, saline flushes were used. PK parameters in participants with SIADH following tolvaptan administration for three different doses are presented below.|Baseline to Day 2|PK parameter dataset comprised of all participants who had taken 1 dose of study medication and had evaluable PK data.||ng·h/mL||Standard Deviation|Mean
652342|NCT02009878|Secondary|Tmax (Time to Maximum (Peak) Plasma Concentration) for Tolvaptan in Plasma|Blood samples for determination of plasma concentrations of tolvaptan were collected predose and 1, 2, 3, 4, 8, 12, 16, and 24 hours postdose on Day 1 or at ET. PK parameters in participants with SIADH following tolvaptan administration for three different doses are presented below.|Baseline to Day 2|PK parameter dataset comprised of all participants who had taken 1 dose of study medication and had evaluable PK data.||hours||Full Range|Median
652343|NCT02009878|Secondary|Cmax (Maximum (Peak) Plasma Concentration) for Tolvaptan in Plasma.|Blood samples for determination of plasma concentrations of tolvaptan were collected predose and 1, 2, 3, 4, 8, 12, 16, and 24 hours postdose on Day 1 or at ET. PK parameters in participants with SIADH following tolvaptan administration for three different doses are presented below.|Baseline to Day 2|PK parameter dataset comprised of all participants who had taken 1 dose of study medication and had evaluable PK data.||ng/mL||Standard Deviation|Mean
652344|NCT02009878|Primary|Maximal Increase From Baseline in Serum Sodium Concentration Following Tolvaptan Administration.|Maximal increase in serum sodium is summarized below by tolvaptan dose. Blood samples for determination of plasma concentrations of tolvaptan were collected predose and at 1, 2, 3, 4, 6, 8, 12, 16, and 24 hours postdose on Day 1 or at Early Termination (ET).|Baseline to Day 2|PD dataset comprised of all participants who had taken 1 dose of study medication and had all observed measurements.||mmol/L||Standard Deviation|Mean
652345|NCT02009865|Secondary|Percent Change in Triglyceride(mg/dL) in Subjects With Biochemically Defined Fredrickson Type V (Triglyceride/Very-Low-Density Lipoprotein Cholesterol ≥6)|This secondary endpoint in subjects with Biochemically Defined Fredrickson Type V (Triglyceride/Very-Low-Density Lipoprotein Cholesterol ≥6), together with the 2nd. and 3rd.secondary ones, was treated as the core secondary, and the p value from the hypothesis test on its treatment comparison was adjusted by using Hommel's procedure.|From Baseline to Week 12 Endpoint|FAS||Percentage of change (%)||Inter-Quartile Range|Median
652346|NCT02009865|Secondary|Percent Change in High-Density Lipoprotein Cholesterol (mg/dL)|This secondary endpoint, together with the 2nd. and 4th. secondary ones, was treated as the core secondary, and the p value from the hypothesis test on its treatment comparison was adjusted by using Hommel's procedure.|From Baseline to Week 12 Endpoint|FAS||Percentage of change (%)||Inter-Quartile Range|Median
652347|NCT02009865|Secondary|Percent Change in Non-High-Density Lipoprotein Cholesterol (mg/dL)|This secondary endpoint, together with the 3rd. and 4th secondary ones, was treated as the core secondary, and the p value from the hypothesis test on its treatment comparison was adjusted by using Hommel's procedure.|From Baseline to Week 12 Endpoint|FAS||Percentage of change (%)||Inter-Quartile Range|Median
652359|NCT02009722|Primary|Dose of IT Morphine and IT Hydromorphone for Adequate Analgesia (Pain Score Less Than or Equal to 3) in 90% of Patients|Each patient will be interviewed by a member of the study team 12 hours after receiving their spinal anesthetic (which will include either hydromorphone or morphine). Patients will be asked to rate their current level of pain on a scale of 0 (no pain) to 10 (worst pain imaginable). A pain score <4 will be considered a success. The up-down sequential allocation method will be used to determine the dose (mcg) of IT hydromorphone and IT morphine for subsequent patients|12 hours after administration of spinal anesthesia|The primary outcome was determining the optimal dose of IT morphine and IT hydromorphone for patients undergoing cesarean delivery. Study was designed to determine the ED90 (effective dose in 90% patients; effective dose meaning a VAS score for pain of 3 or less at 12 hours after spinal placement).||micrograms|||Number
652360|NCT02009696|Primary|Percentage of Participants Free of R-wave Sensing Attenuation|Evaluate the percentage of subjects who experience R-wave attenuation between the pre-MRI and one-month post-MRI follow-up.|Between Pre-MRI and 1 Month Post-MRI|Number of participants with a ventricular lead and same ventricular sensing polarity (either uni- or bi-polar) at pre-MRI and one-month post-MRI.||percentage of participants||95% Confidence Interval|Number
652361|NCT02009696|Primary|Percentage of Participants Free of P-wave Sensing Attenuation|Evaluate the percentage of subjects who experience P-wave attenuation between the pre-MRI and one-month post-MRI follow-up.|Between Pre-MRI and 1 Month Post-MRI|Number of participants with an atrial lead and same sensing polarity (either uni- or bi-polar) at pre-MRI and one-month post-MRI.||percentage of participants||95% Confidence Interval|Number
652362|NCT02009696|Primary|Percentage of Participants Free of Ventricular Pacing Threshold Rise|Evaluate the percentage of ventricular pacing leads with a pacing threshold increase between the Pre-MRI and one-month post-MRI follow-up.|Between Pre-MRI and 1 Month Post-MRI|Number of participants with a ventricular lead and same ventricular threshold polarity (either uni- or bi-polar) at pre-MRI and one-month post-MRI.||percentage of participants||95% Confidence Interval|Number
652363|NCT02009696|Primary|Percentage of Participants Free of Atrial Pacing Threshold Rise|Evaluate the percentage of atrial pacing leads with a pacing threshold increaess between the Pre-MRI and one-month post-MRI follow-up.|Between Pre-MRI and 1 Month Post-MRI|Number of participants with an atrial lead and same atrial threshold polarity (either uni- or bi-polar) at pre-MRI and one-month post-MRI.||percentage of participants||95% Confidence Interval|Number
652364|NCT02009696|Primary|MRI and Pacing System Related Serious Adverse Device Effect (SADE) Free Rate||1 Month Post-MRI|||percentage of participants||95% Confidence Interval|Number
652365|NCT02009163|Secondary|Total Scores For The Amphetamine Cessation Symptom Assessment (ACSA) Scale During Follow-up|The ACSA was used in this study to assess potential withdrawal symptoms associated with chronic use of SPD489. The ACSA is a self-completed scale used to assess withdrawal symptoms. The scale has 16 symptom items rated on a 5-point scale ranging from 0 (not at all) to 4 (extremely). The ACSA total score ranges from 0-64, where a higher score indicates greater withdrawal symptom severity.|Visit 21 (26 weeks after randomization [Week 38] or Early Termination) and Visit 22 (7 days post last dose)|The RSAS. Four (placebo) and one (SPD489) participants were randomized but not treated and thus not included in the RSAS. Visits 21 and 22 could include participants who discontinued but completed a final safety and efficacy assessment. Not all participants had data for this outcome.||units on a scale||Standard Deviation|Mean
652366|NCT02009163|Secondary|Number of Participants With a Positive Response on The Columbia Suicide Severity Rating Scale (C-SSRS) at Endpoint of The Randomized-withdrawal Period|"The C-SSRS is a semistructured interview that captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The interview was initiated with 5 (yes/no) questions, presented in ascending order of severity, about suicidal ideation. The most severe type of ideation was rated for frequency, duration, controllability, deterrents, and reason. If the answer to the first 2 ideation questions was yes, the clinician asked questions 3-5. Active suicidal ideation included any participant who answered yes to questions 2-5. If the answers to ideation questions 1 and 2 were No, then the clinician proceeded to 5 (yes/no) questions that addressed suicidal behavior, which was categorized as actual attempt, interrupted attempt, aborted attempt, preparatory acts or behaviors, and completed suicide."|Visit 21 (26 weeks after randomization [Week 38] or Early Termination)|The Randomized Safety Analysis Set (RSAS), defined as participants in the SAS who were randomized and took at least 1 dose of investigational product in the randomized-withdrawal period. Four (placebo) and one (SPD489) participants were randomized but not treated and thus not included in the RSAS. Three participants had no data for this outcome.||participants|||Number
652367|NCT02009163|Secondary|Number of Participants With a Positive Response on The Columbia Suicide Severity Rating Scale (C-SSRS) at Endpoint of The Open-label Period|"The C-SSRS is a semistructured interview that captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The interview was initiated with 5 (yes/no) questions, presented in ascending order of severity, about suicidal ideation. The most severe type of ideation was rated for frequency, duration, controllability, deterrents, and reason. If the answer to the first 2 ideation questions was yes, the clinician asked questions 3-5. Active suicidal ideation included any participant who answered yes to questions 2-5. If the answers to ideation questions 1 and 2 were No, then the clinician proceeded to 5 (yes/no) questions that addressed suicidal behavior, which was categorized as actual attempt, interrupted attempt, aborted attempt, preparatory acts or behaviors, and completed suicide."|Visit 8 (12 weeks after start of open-label treatment [Week 12])|The OSP. Three participants in the OSP did not have data collected for this outcome. Visit 8 included only participants who completed open-label treatment.||participants|||Number
652396|NCT02008526|Primary|Methamphetamine Use|Self-reported and/or biomarker-confirmed methamphetamine use assessed at baseline and 9-month follow-up assessment.|9-months post randomization|Number of participants retained through 9-month follow-up.||Days Used in the Past 30 Days||Standard Deviation|Mean
652643|NCT02003534|Primary|Change From Baseline in Intraocular Pressure (IOP) in the Study Eye|IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening).|Baseline, Month 3|Intent-to-Treat: patients with baseline data and data at the indicated time point||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
652368|NCT02009163|Secondary|Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Anxiety And Depression at Endpoint of The Randomized-withdrawal Period|The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) is a health-related quality of life (QoL) measure that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health.|Visit 21 (26 weeks after randomization [Week 38] or Early Termination)|The FAS. Three participants in the placebo group were randomized and included in the RSAS but not in the FAS. Not all participants in the FAS had data collected for this outcome. Visit 21 could include participants who discontinued but completed a final safety and efficacy assessment.||percentage of participants|||Number
652369|NCT02009163|Secondary|Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Anxiety And Depression at Endpoint of The Open-label Period|The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) is a health-related quality of life (QoL) measure that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health.|Visit 8 (12 weeks after start of open-label treatment [Week 12] or Early Termination)|The OSP. Not all participants had data collected for this outcome. Visit 8 could include participants who discontinued but completed a safety and efficacy assessment.||percentage of participants|||Number
652370|NCT02009163|Secondary|Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Pain and Discomfort at Endpoint of The Randomized-withdrawal Period|The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) is a health-related quality of life (QoL) measure that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health.|Visit 21 (26 weeks after randomization [Week 38] or Early Termination)|The FAS. Three participants in the placebo group were randomized and included in the RSAS but not included in the FAS. Not all participants in the FAS had data collected for this outcome. Visit 21 could include participants who discontinued but completed a final safety and efficacy assessment.||percentage of participants|||Number
652371|NCT02009163|Secondary|Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Pain and Discomfort at Endpoint of The Open-label Period|The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) is a health-related quality of life (QoL) measure that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health.|Visit 8 (12 weeks after start of open-label treatment [Week 12] or Early Termination)|The OSP. Not all participants had data collected for this outcome. Visit 8 could include participants who discontinued but completed a safety and efficacy assessment.||percentage of participants|||Number
652372|NCT02009163|Secondary|Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Usual Activities at Endpoint of The Randomized-withdrawal Period|The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) is a health-related quality of life (QoL) measure that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health.|Visit 21 (26 weeks after randomization [Week 38] or Early Termination)|The FAS. Three participants in the placebo group were randomized and included in the RSAS but not in the FAS. Not all participants in the FAS had data collected for this outcome. Visit 21 could include participants who discontinued but completed a final safety and efficacy assessment.||percentage of participants|||Number
652373|NCT02009163|Secondary|Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Usual Activities at Endpoint of The Open-label Period|The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) is a health-related quality of life (QoL) measure that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health.|Visit 8 (12 weeks after start of open-label treatment [Week 12] or Early Termination)|The OSP. Not all participants had data collected for this outcome. Visit 8 could include participants who discontinued but completed a safety and efficacy assessment.||percentage of participants|||Number
652374|NCT02009163|Secondary|Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Self Care at Endpoint of The Randomized-withdrawal Period|The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) is a health-related quality of life (QoL) measure that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health.|Visit 21 (26 weeks after randomization [Week 38] or Early Termination)|The FAS. Three participants in the placebo group were randomized and included in the RSAS but not included in the FAS. Not all participants in the FAS had data collected for this outcome. Visit 21 could include participants who discontinued but completed a final safety and efficacy assessment.||percentage of participants|||Number
652375|NCT02009163|Secondary|Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Self Care at Endpoint of The Open-label Period|The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) is a health-related quality of life (QoL) measure that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health.|Visit 8 (12 weeks after start of open-label treatment [Week 12] or Early Termination)|The OSP. Not all participants had data collected for this outcome. Visit 8 could include participants who discontinued but completed a safety and efficacy assessment.||percentage of participants|||Number
652376|NCT02009163|Secondary|Percent of Participants Within Each Category of The EuroQuol Group 5­-Dimension 5­-Level Self­-Report Questionnaire (EQ­-5D­-5L) For Mobility at Endpoint of The Randomized-withdrawal Period|The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) is a health-related quality of life (QoL) measure that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health.|Visit 21 (26 weeks after randomization [Week 38] or Early Termination)|The FAS. Three participants in the placebo group were randomized and included in the RSAS but not in the FAS. Not all participants in the FAS had data collected for this outcome. Visit 21 could include participants who discontinued but completed a final safety and efficacy assessment.||percentage of participants|||Number
652377|NCT02009163|Secondary|Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Mobility at Endpoint of The Open-label Period|The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) is a health-related quality of life (QoL) measure that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health.|Visit 8 (12 weeks after start of open-label treatment [Week 12] or Early Termination)|The Open-label Safety Population (OSP), defined as participants who had taken at least 1 dose of SPD489 in the open-label period and who had a post-baseline safety assessment. Not all participants had data collected for this outcome. Visit 8 could include participants who discontinued but completed a safety and efficacy assessment.||percentage of participants|||Number
652378|NCT02009163|Secondary|Change From Randomized-Withdrawal Baseline in The Total Score of The Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) During The Randomized-withdrawal Period|The Y-BOCS-BE measures the obsession of binge eating thoughts and compulsiveness of binge eating behaviors. The scale is a clinician rated, 10-item scale, each item rated from 0 (no symptoms) to 4 (extreme symptoms). The scale includes questions regarding the amount of time spent on obsessions, impairment or distress experienced, and resistance and control over these thoughts. The same types of questions were asked about compulsions (ie, time spent, interference, etc.).Total scores range from 0 to 40. A total score of 0-7 is sub-clinical, 8-15 is mild, 16-23 is moderate, 24-31 is severe, and 32-40 is extreme. A decrease from baseline in Y-BOCS-BE Total Score represents an improvement in obsession with binge-eating thoughts or compulsiveness of binge-eating behaviors.|Randomized-withdrawal baseline (Visit 8; 12 weeks after start of open-label treatment [Week 12]), Visit 21 (26 weeks after randomization [Week 38])|The FAS. Three participants in the placebo group were randomized and included in the RSAS but not in the FAS. Not all participants in the FAS had data collected for this outcome. Visit 21 included only participants who completed randomized treatment (placebo: n=54; SPD489: n=107).||units on a scale||Standard Error|Least Squares Mean
652379|NCT02009163|Secondary|Percent of Participants Within Each Category of The Clinical Global Impression-Severity of Illness (CGI-S) Scale at Endpoint of The Randomized-withdrawal Period|The CGI-S permits a global evaluation of a subject’s condition and severity of symptoms. The CGI-S was performed to rate the severity of a subject’s condition based on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill).|Visit 21 (26 weeks after randomization [Week 38] or Early Termination)|The FAS. Three participants in the placebo group were randomized and included in the RSAS but not in the FAS. Visit 21 could include participants who discontinued but completed a final safety and efficacy assessment.||percentage of participants|||Number
652380|NCT02009163|Secondary|Change From Randomized-Withdrawal Baseline in The Number of Binge­ Eating Days Per Week During The Randomized-withdrawal Period|A binge day was defined as days during which at least 1 binge episode occurred. As assessed by clinical interview based on subject binge diary. Binge eating information was captured via a self-report paper diary. The binge diary captured the number of binges per day, total hours per day spent binging, type of binge (at mealtime or at another time other than mealtime), and a description of the binge (amounts and types of foods). Binge frequency was reviewed by the clinician with the subject to confirm reported binge episodes per day. A negative change from Baseline indicates that binge-related behavior decreased. The randomized ­withdrawal-baseline was defined as the weekly average number of binge days for the 14 days prior to the Randomization Visit (Visit 8).|Randomized­-withdrawal baseline (Visit 8; 12 weeks after start of open­ label treatment [Week 12]), Visit 21 (26 weeks after randomization [Week 38])|The FAS. Three participants in the placebo group were randomized and included in the RSAS but not in the FAS. Not all participants in the FAS had data collected for this outcome. Visit 21 included only participants who completed randomized treatment (placebo: n=50; SPD489: n=102).||days||Standard Error|Least Squares Mean
652424|NCT02008227|Primary|Overall Survival (OS): PP-ITT|OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology.|Baseline until death due to any cause (up to approximately 2.25 years)|The PP-ITT analysis set.||Months||95% Confidence Interval|Median
655264|NCT01953328|Secondary|Change From Baseline in LDL-C at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||mg/dL||Standard Error|Least Squares Mean
652381|NCT02009163|Primary|Time to Relapse From Date of Randomization to Endpoint of The Randomized-withdrawal Period|Relapse status was assessed during the double-blind treatment phase and was defined as having 2 or more binge days per week for 2 consecutive weeks (14 consecutive days) prior to any visit and having an increase in Clinical Global Impressions-Severity (CGI-S) score of 2 or more points compared to the randomized-withdrawal baseline (date of relapse – date of randomization). Binge eating information was captured via a self-report paper diary. The binge diary captured the number of binges per day, total hours per day spent binging, type of binge (at mealtime or at another time other than mealtime), and a description of the binge (amounts and types of foods). Binge frequency was reviewed by the clinician with the subject to confirm reported binge episodes per day. The CGI-S was performed to rate the severity of a subject’s condition using a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill).|Visit 21 (26 weeks after randomization [Week 38] or Early Termination)|The Full Analysis Set (FAS): participants in the Randomized Safety Analysis Set (RSAS) with at least 1 post-randomization CGI-S assessment. Three participants in the placebo group were randomized and included in the RSAS but not in the FAS. Visit 21 could include participants who discontinued but completed a final safety and efficacy assessment.||days||Inter-Quartile Range|Median
652382|NCT02008942|Primary|Time to 99% Inhibition of Serum Thromboxane|Serial measurements of aspirin anti-platelet activity will be collected over 11 days, and compared between groups, to allow a determination of pharmacodynamic (anti-platelet) bioequivalence between study drugs. Aspirin's antiplatelet activity is measured by the capacity of platelets to generate serum thromboxane (a surrogate marker for inhibition of COX-1 by aspirin). Inhibition of serum thromboxane is a key marker of antiplatelet efficacy.|11 days|Pharmacodynamic (PD) Evaluable Population - patients in the intent-to-treat population who received a full treatment regimen for each of 2 study drugs, had all scheduled PD blood draws, and had no other major protocol violations.||hours||Standard Deviation|Mean
652383|NCT02008682|Secondary|Number of Confirmed Hypoglycaemic Episodes|confirmed hypoglycaemic episode defined as severe (unable to treat her/himself) or biochemically confirmed by a plasma glucose < 3.1 mmol/L|Weeks 0-26|Safety analysis set included all subjects receiving at least one dose of investigational product.||episodes|||Number
652384|NCT02008682|Secondary|Subjects Who Achieve (Yes/no) HbA1c Below or Equal to 6.5 % (American Association of Clinical Endocrinologists Target)|Calculated as the percentage of subjects achieving treatment target of HbA1c <= 6.5% at Week 26|After 26 weeks of treatment|Full analysis set was defined as all randomised and exposed subjects who had any post randomisation data. Missing data was imputed using a mixed model for repeated measurements. The subjects would not contribute to the analyses if they didn’t have a corresponding post-baseline value.||percentage of subjects|||Number
652385|NCT02008682|Secondary|Subjects Who Achieve (Yes/no) HbA1c Below 7.0 % (American Diabetes Association Target)|Calculated as the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 26|After 26 weeks of treatment|Full analysis set was defined as all randomised and exposed subjects who had any post randomisation data. Missing data was imputed using a mixed model for repeated measurements. The subjects would not contribute to the analyses if they didn’t have a corresponding post-baseline value.||percentage of subjects|||Number
652386|NCT02008682|Secondary|Change From Baseline in 7-point Self-measured Plasma Glucose Profile|Mean change from baseline in mean of 7-point self-measured plasma glucose at week 26. The 7-point self-measured plasma glucose levels were measured before and after (120 minutes after the start of the meal) the three main meals (breakfast, lunch and dinner), and at bed time.|Week 0, week 26|Full analysis set was defined as all randomised and exposed subjects who had any post randomisation data. Missing data was imputed using a mixed model for repeated measurements. The subjects would not contribute to the analyses if they didn’t have a corresponding post-baseline value.||mmol/L||Standard Deviation|Mean
652387|NCT02008682|Secondary|Change From Baseline in Fasting Plasma Glucose|Mean change from baseline in fasting plasma glucose (FPG) at Week 26.|Week 0, week 26|Full analysis set was defined as all randomised and exposed subjects who had any post randomisation data. Missing data was imputed using a mixed model for repeated measurements. The subjects would not contribute to the analyses if they didn’t have a corresponding post-baseline value.||mmol/L||Standard Deviation|Mean
652388|NCT02008682|Primary|Change From Baseline in Glycosylated Haemoglobin (HbA1c)|Mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 26.|Week 0, week 26|Full analysis set was defined as all randomised and exposed subjects who had any post randomisation data. Missing data was imputed using a mixed model for repeated measurements. The subjects would not contribute to the analyses if they didn’t have a corresponding post-baseline value.||Percent (%) glycosylated haemoglobin||Standard Deviation|Mean
652389|NCT02008617|Secondary|Quality of Recovery (QoR15)|Quality of recovery (QoR15) is a questionnaire that asks 15 questions regarding how the participant has felt in the last 24 hours. Each question is followed by an 11-point numerical rating scale (0 = “none of the time” to 10 = “all of the time”; maximum score 150). The higher the QoR15 total score, the worse the quality of recovery reported.|24hrs|||units on a scale||Inter-Quartile Range|Median
652390|NCT02008617|Secondary|Patient Satisfaction|Patient satisfaction with pain control scale ranges from 0 (no satisfaction) to 10 (very satisfied).|24hr|||units on a scale||Inter-Quartile Range|Median
652391|NCT02008617|Secondary|Pain Score|Numeric Rating Scale (NRS) (NRS pain scores; 0 = no pain,10 = excruciating pain) in the back of the knee recorded every 4 hours up to 24hrs following surgery. Pain Bruden scale ranges from 0 (no pain) to 240 (extreme pain). For example, pain burden of 120 is equivalent to a NRS score of 5 out of 10.|Pain Burden at 24hrs|||units on a scale||Inter-Quartile Range|Median
652392|NCT02008617|Primary|Opioid Consumption|Opioid consumption (mg morphine equivalents)|24 hours|||mg morphine equivalents||Inter-Quartile Range|Median
652393|NCT02008526|Secondary|HIV Primary Care|HIV-positive participants will be assessed according to their linkage/retention in HIV primary care and adherence to ART medication at 8-weeks, 3-, 6-, and 9-months post-randomization.|8-weeks post randomization, 3-/6-/9-months post randomization||||||
652394|NCT02008526|Primary|Cost Effectiveness|Cost-effectiveness data is collected quarterly throughout the course of the study using the UNAIDS template.|up to 36 months||||||
652395|NCT02008526|Primary|HIV Sexual Risk Behavior|Engagement in condomless anal intercourse was assessed at baseline and 9-month post-randomization follow-up.|9-months post randomization|Participants retained through nine months post randomization.||# Episodes (Past 30 Days)||Standard Deviation|Mean
652397|NCT02008227|Secondary|EORTC QLQ-LC13 Questionnaire Score: Sore Mouth|QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for sore mouth.|Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)|The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.||Units on a scale||Standard Deviation|Mean
652398|NCT02008227|Secondary|EORTC QLQ-LC13 Questionnaire Score: Pain in Other Parts|QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for pain in other parts.|Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)|The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.||Units on a scale||Standard Deviation|Mean
652399|NCT02008227|Secondary|EORTC QLQ-LC13 Questionnaire Score: Peripheral Neuropathy|QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for peripheral neuropathy.|Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)|The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.||Units on a scale||Standard Deviation|Mean
652400|NCT02008227|Secondary|EORTC QLQ-LC13 Questionnaire Score: Pain in Chest|QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for pain in chest.|Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)|The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.||Units on a scale||Standard Deviation|Mean
652401|NCT02008227|Secondary|EORTC QLQ-LC13 Questionnaire Score: Pain in Arm or Shoulder|QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for pain in arm or shoulder.|Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)|The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.||Units on a scale||Standard Deviation|Mean
652402|NCT02008227|Secondary|EORTC QLQ-LC13 Questionnaire Score: Hemoptysis|QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for hemoptysis.|Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)|The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.||Units on a scale||Standard Deviation|Mean
664257|NCT01788215|Primary|Total Serum Testosterone|We will determine total serum testosterone levels in all participating subjects at week 12.|week 12|||ng/dL||Standard Deviation|Mean
652403|NCT02008227|Secondary|EORTC QLQ-LC13 Questionnaire Score: Dyspnea|QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for dyspnea.|Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)|The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.||Units on a scale||Standard Deviation|Mean
652404|NCT02008227|Secondary|EORTC QLQ-LC13 Questionnaire Score: Dysphagia|QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for dysphagia.|Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)|The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.||Units on a scale||Standard Deviation|Mean
652405|NCT02008227|Secondary|EORTC QLQ-LC13 Questionnaire Score: Coughing|QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for coughing.|Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)|The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.||Units on a scale||Standard Deviation|Mean
652406|NCT02008227|Secondary|EORTC QLQ-LC13 Questionnaire Score: Alopecia|QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for alopecia.|Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)|The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.||Units on a scale||Standard Deviation|Mean
652407|NCT02008227|Secondary|EORTC QLQ-C30 Questionnaire Score: Symptom Subscale|EORTC QLQ-C30 included GHS/QOL, functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). For this instrument, GHS/QOL and functional scales were linearly transformed so each score ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement). Symptom scales/items were also linearly transformed so each score ranged 0-100, where higher scores indicate worse symptoms (e.g., more severe/worsened) and lower scores indicate less symptoms (e.g., less severe/improvement).|Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)|The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.||Units on a scale||Standard Deviation|Mean
652439|NCT02007577|Primary|Quantification of Insulin Action With the Insulin Suppression Test (IST)|Compare changes in insulin sensitivity as assesses by the IST before and after treatment between salsalate and placebo group|after treatment for one month|||mmol/L||95% Confidence Interval|Median
652440|NCT02007434|Secondary|Patient Experience Questions|"Participants were asked to complete 3 patient experience questions, each answered as Yes or No:
Given your experience in this study:
Would you recommend this procedure to a friend?
Would you agree to receive additional treatments?
Has the treatment you received in this study affected your normal activities?
The percentage of participants answering Yes on each question is reported."|Day 84|Safety analysis set with available data at each time point||percentage of participants|||Number
652441|NCT02007434|Secondary|Change From Baseline in Submental Fat Thickness|Submental thickness was measured using caliper devices.|Baseline and Day 84|Safety analysis set with available data at both time points||mm||Standard Deviation|Mean
652408|NCT02008227|Secondary|EORTC QLQ-C30 Questionnaire Score: GHS Scale|EORTC QLQ-C30 included GHS/QOL, functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). For this instrument, GHS/QOL and functional scales were linearly transformed so each score ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement). Symptom scales/items were also linearly transformed so each score ranged 0-100, where higher scores indicate worse symptoms (e.g., more severe/worsened) and lower scores indicate less symptoms (e.g., less severe/improvement).|Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)|The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.||Units on a scale||Standard Deviation|Mean
652409|NCT02008227|Secondary|EORTC QLQ-C30 Questionnaire Score: Functional Subscales|EORTC QLQ-C30 included GHS/QOL, functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). For this instrument, GHS/QOL and functional scales were linearly transformed so each score ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement). Symptom scales/items were also linearly transformed so each score ranged 0-100, where higher scores indicate worse symptoms (e.g., more severe/worsened) and lower scores indicate less symptoms (e.g., less severe/improvement).|Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)|The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.||Units on a scale||Standard Deviation|Mean
652410|NCT02008227|Secondary|EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items|EORTC QLQ-C30 included global health status (GHS)/quality of life (QOL), functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). For this instrument, GHS/QOL and functional scales were linearly transformed so each score ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement). Symptom scales/items were also linearly transformed so each score ranged 0-100, where higher scores indicate worse symptoms (e.g., more severe/worsened) and lower scores indicate less symptoms (e.g., less severe/improvement).|Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)|The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.||Units on a scale||Standard Deviation|Mean
652411|NCT02008227|Secondary|Time to Deterioration (TTD) in Patient-Reported Lung Cancer Symptoms, Using the European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire (QLQ) Lung Cancer Supplemental Module 13 (LC13)|TTD in patient-reported lung cancer symptoms (pain in chest or in arm/shoulder, dyspnea, or cough) was a composite endpoint defined as the time from randomization to the earliest time the participant’s scale scores showed a 10 point or greater increase after baseline in any of the symptoms. A >/=10-point change in the score perceived by participants was considered as clinically significant. The QLQ-LC13 consisted of 1 multi-item scale and 9 single items that assessed the specific symptoms (dyspnea, cough, hemoptysis, and site specific pain), side effects (sore mouth, dysphagia, neuropathy, and alopecia), and pain medication use of lung cancer participants receiving chemotherapy. Scale score range: 0 to 100. Higher symptom score = greater degree of symptom severity.|Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years) (1 Cycle = 21 days)|The PP-ITT analysis set.||Months||95% Confidence Interval|Median
652412|NCT02008227|Secondary|Minimum Observed Serum Atezolizumab Concentration (Cmin)||Predose (Hr 0) on Day 1 of Cycles 1, 2, 3, 4, 8, 16, 24, 32, EOT (approximately 2.25 years); 120 days after EOT (approximately 2.25 years) (1 Cycle=21 days)|PK evaluable participants. Here, 'n' signifies those participants evaluated for this measure at specific time point. All 606 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.||mcg/mL||Standard Deviation|Mean
652413|NCT02008227|Secondary|Maximum Observed Serum Atezolizumab Concentration (Cmax)||Predose (Hr 0), 30 minutes (min) post-infusion (infusion duration: 60 min) on Cycle 1 Day 1 (1 Cycle=21 days)|Pharmacokinetic (PK) evaluable population included participants who received atezolizumab treatment and had at least one measurable PK concentration.||Microgram per milliliter (mcg/mL)||Standard Deviation|Mean
652414|NCT02008227|Secondary|Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) Against Atezolizumab||Baseline up to approximately 2.25 years (assessed at predose [Hour {Hr} 0] on Day 1 of Cycles 1, 2, 3, 4, 8, 16, then every 8 cycles up to end of treatment (EOT) [approximately 2.25 years]; 120 days after EOT [approximately 2.25 years] [1 Cycle=21 days])|ATA evaluable population included all participants who received atezolizumab treatment and had at least one post treatment ATA result.||Percentage of Participants|||Number
652442|NCT02007434|Secondary|Change From Baseline in Submental Skin Laxity Grades (SMSLG)|Skin laxity assessment was based on clinical evaluation and palpation of the submental area on the following scale: 1 = no laxity; 2 = mild laxity; 3 = moderate laxity; 4 = severe laxity. A negative change from Baseline indicates improvement.|Baseline and Day 84|Safety analysis set with available data at both time points||units on a scale||Standard Deviation|Mean
652415|NCT02008227|Secondary|DOR as Determined by Investigator Using RECIST v1.1: TC1/2/3 or IC1/2/3 Subgroup of PP|DOR:Duration from the first tumor assessment that supports the participant's objective response to PD or death due to any cause,whichever occurs first.CR:complete disappearance of all target lesions and non-target disease.All nodes,both target and non-target,must decrease to normal. No new lesions.PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR.Participants who have not experienced PD at the time of analysis were censored at the time of the last tumor assessment.Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day.PD:at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm,progression of existing non-target lesions,or presence of new lesions.DOR was estimated using KM methodology.|From first objective response of CR or PR to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)|The TC1/2/3 or IC1/2/3 subgroup of PP||Months||95% Confidence Interval|Median
652416|NCT02008227|Secondary|Duration of Response (DOR) as Determined by Investigator Using RECIST v1.1: PP-ITT|DOR:Duration from the first tumor assessment that supports the participant's objective response to PD or death due to any cause,whichever occurs first.CR:complete disappearance of all target lesions and non-target disease.All nodes,both target and non-target,must decrease to normal. No new lesions.PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR.Participants who have not experienced PD at the time of analysis were censored at the time of the last tumor assessment.Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day.PD:at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm,progression of existing non-target lesions,or presence of new lesions.DOR was estimated using KM methodology.|From first objective response of CR or PR to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)|The PP-ITT analysis set.||Months||95% Confidence Interval|Median
652417|NCT02008227|Secondary|Percentage of Participants With Objective Response as Determined Using RECIST v1.1: TC1/2/3 or IC1/2/3 Subgroup of PP|Objective response is defined as a CR or PR as determined by the Investigator using RECIST v1.1 on 2 consecutive occasions at least 6 weeks apart. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR. No new lesions.|Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)|The TC1/2/3 or IC1/2/3 subgroup of PP||Percentage of Participants||95% Confidence Interval|Number
652418|NCT02008227|Secondary|Percentage of Participants With Objective Response as Determined Using RECIST v1.1: PP-ITT|Objective response is defined as a complete response (CR) or partial response (PR) as determined by the Investigator using RECIST v1.1 on 2 consecutive occasions at least 6 weeks apart. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than [<] 10 mm). No new lesions. At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR. No new lesions.|Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)|The PP-ITT analysis set.||Percentage of Participants||95% Confidence Interval|Number
652419|NCT02008227|Secondary|PFS as Determined by Investigator Using RECIST v1.1: TC1/2/3 or IC1/2/3 Subgroup of PP|PFS is defined as the time between the date of randomization and the date of first documented PD or death, whichever occurs first. Participants who are alive and have not experienced PD at the time of analysis were censored at the time of the last tumor assessment. Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, or presence of new lesions.|Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)|The TC1/2/3 or IC1/2/3 subgroup of PP||Months||95% Confidence Interval|Median
652420|NCT02008227|Secondary|Progression-Free Survival (PFS) as Determined by Investigator Using RECIST v1.1: PP-ITT|PFS is defined as the time between the date of randomization and the date of first documented PD or death, whichever occurs first. Participants who are alive and have not experienced PD at the time of analysis were censored at the time of the last tumor assessment. Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, or presence of new lesions.|Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)|The PP-ITT analysis set.||Months||95% Confidence Interval|Median
652421|NCT02008227|Secondary|Percentage of Participants With PD as Determined by Investigator Using RECIST v1.1 or Death: TC1/2/3 or IC1/2/3 Subgroup of PP|PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, or presence of new lesions.|Baseline up to PD or Death (up to approximately 2.25 years)|TC1/2/3 or IC1/2/3 subgroup of PP||Percentage of Participants|||Number
652422|NCT02008227|Secondary|Percentage of Participants With Disease Progression (PD) as Determined by Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or Death: PP-ITT|PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 millimeters (mm), or presence of new lesions.|Baseline up to PD or Death (up to approximately 2.25 years)|The PP-ITT analysis set||Percentage of Participants|||Number
652423|NCT02008227|Primary|OS: TC1/2/3 or IC1/2/3 Subgroup of PP|OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology.|Baseline until death due to any cause (up to approximately 2.25 years)|TC1/2/3 or IC1/2/3 subgroup of PP||Months||95% Confidence Interval|Median
652425|NCT02008227|Primary|Percentage of Participants Who Died: Tumor Cells (TC)1/2/3 or Tumor-Infiltrating Immune Cells (IC)1/2/3 Subgroup of PP|Percentage of participants who died among TC1/2/3 or IC1/2/3 subgroup of PP-ITT were reported. TC1 = presence of discernible programmed death-ligand 1 (PD-L1) staining of any intensity in >/=1% and <5% TCs; TC2: presence of discernible PD-L1 staining of any intensity in >/=5% and <50% TCs; TC3 = presence of discernible PD-L1 staining of any intensity in >/=50% TCs; IC1 = presence of discernible PD-L1 staining of any intensity in ICs covering between >/=1% and <5% of tumor area occupied by tumor cells, associated intratumoral, and contiguous peri-tumoral desmoplastic stroma; IC2 = presence of discernible PD-L1 staining of any intensity in ICs covering between >/=5% and <10% of tumor area occupied by tumor cells, associated intratumoral, and contiguous peri-tumoral desmoplastic stroma; IC3 = presence of discernible PD-L1 staining of any intensity in ICs covering >/=10% of tumor area occupied by tumor cells, associated intratumoral, and contiguous peri-tumoral desmoplastic stroma.|Baseline until death due to any cause (up to approximately 2.25 years)|TC1/2/3 or IC1/2/3 subgroup within PP included ITT participants with the corresponding programmed death-ligand 1 (PD-L1) expression status.||Percentage of Participants|||Number
652426|NCT02008227|Primary|Percentage of Participants Who Died: PP-ITT||Baseline until death due to any cause (up to approximately 2.25 years)|PP-ITT analysis set included the first 850 randomized ITT participants regardless of whether they received any study drug.||Percentage of Participants|||Number
652427|NCT02007954|Other Pre-specified|Exploratory Endpoint - Tmax of Doxorubicin and Doxorubicinol Post DEBDOX-M1 TACE|Time taken to reach maximum concentration (Tmax) of doxorubicin and its metabolite doxorubicinol post DEBDOX-M1 in the first 10 patients enrolled on protocol. Time points assessed in protocol were pre-dose, and then 5min, 20min, 40min, 1hr, 2hr, and 24hr post administration of 50-100mg doxorubicin..|24 hours|||minutes||Standard Deviation|Mean
652428|NCT02007954|Other Pre-specified|Exploratory Endpoint - Total Drug Exposure Over Time (AUC) of Doxorubicin and Doxorubicinol Post TACE|Total drug exposure over time (AUC) of doxorubicin and its metabolite doxorubicinol post DEBDOX in the first 10 patients enrolled on protocol. Time points assessed in protocol were pre-dose, and then 5min, 20min, 40min, 1hr, 2hr, and 24hr post administration of 50-100mg doxorubicin..|24 hours|||ng*h/mL||Standard Deviation|Mean
652429|NCT02007954|Other Pre-specified|Exploratory Endpoint - Pharmacokinetic (PK) Profile of Doxorubicin and Doxorubicinol Post DEBDOX-M1 TACE|"PK analysis of doxorubicin and its metabolite doxorubicinol post DEBDOX-M1 in the first 10 patients enrolled on protocol including peak plasma concentration (Cmax).
Time points assessed in protocol were pre-dose, and then 5min, 20min, 40min, 1hr, 2hr, and 24hr post administration of 50-100mg doxorubicin."|24 hours|||ng/mL||Standard Deviation|Mean
652430|NCT02007954|Secondary|AFP Tumor Marker Pre- and Post-treatment|The change in alpha-fetoprotein tumor marker levels pre- and post-treatment with one DEBDOX-M1 TACE procedure.|1 month|23 out of 24 patients analyzed due to one patient not completing AFP post-TACE.||ng/mL||Full Range|Mean
652431|NCT02007954|Secondary|Efficacy - Number of Patients Downstaged or Bridged to Surgical Interventions|The number of patients who underwent a liver transplantation following treatment on this protocol.|6 months|||Participants|||Count of Participants
652432|NCT02007954|Secondary|Efficacy - Tumor Response by mRECIST|"Efficacy as assessed by radiographic tumor response using modified RECIST (mRECIST) criteria at baseline and at 1-month imaging following TACE treatments.
Complete Response (CR): Disappearance of any intratumoral arterial enhancement in all target lesions Partial Response (PR): At least 30% decrease in the sum of diameters of viable target lesions, taking as reference the baseline sum of the diameters of target lesions Progressive Disease (PD): At least 20% increase in the sum of diameters of viable target lesions, taking as reference the smallest sum of diameters of viable target lesions since treatment started Stable Disease (SD): Any cases that do not qualify for either PR or PD."|1 month|||Participants|||Count of Participants
652433|NCT02007954|Secondary|Efficacy - Tumor Response by qEASL|"Efficacy as assessed by radiographic tumor response using qEASL at baseline and at 1-month imaging following TACE treatments.
Complete Response (CR): Disappearance of any intratumoral arterial enhancement in all target lesions.
Partial Response (PR): At least a 65% decrease in the sum of enhancing tissue volume of the lesions.
Stable Disease (SD): Any cases that do not qualify for complete response, partial response, or progressive disease.
Progressive Disease (PD): an increase of at least 73% in the sum of enhancing tissue volume of the lesions."|1 month|||Participants|||Count of Participants
652434|NCT02007954|Secondary|Efficacy - Tumor Response by EASL|"Efficacy as assessed by radiographic tumor response using EASL amendment at baseline and at 1 month imaging following TACE treatments.
Complete Response (CR): Achieving 100% tumor necrosis of lesions targeted by DEBDOX-M1. Baseline degree of tumor enhancement used as a reference.
Partial Response (PR): Demonstrating greater than 50% tumor necrosis in lesions targeted by DEBDOX-M1.
Stable Disease (SD): Not meeting requirements for CR or PR and not demonstrating evidence of progression of lesions targeted by DEBDOX-M1.
Progressive Disease (PD): Reappearance of or increased tumor enhancement greater than 25% in lesions previously targeted by DEBDOX-M1."|1 month|||Participants|||Count of Participants
652435|NCT02007954|Primary|Collection of Adverse Events Related to Study Device as a Measure of Safety|For safety, all toxicities assessed as being at least possibly related will be analyzed by descriptive statistics to show type, grade (NCI Common Toxicity Criteria v.4 toxicity criteria), frequency and time from DEBDOX-M1TACE.|1 month|30-day toxicity report of device-related adverse events for all 24 patients with classification and grading based on CTCAE v4.0.||Adverse Events|||Number
652436|NCT02007954|Primary|Success of DEBDOX-M1 Procedure as a Measure of Feasibility|Feasibility is defined as achieving an acceptable level of technical success in the use of DEBDOX-M1 beads treating hepatic lesions in patients with hepatocellular carcinoma.|6 months|The 24 patients received a total of 50 DEBDOX-M1 TACE procedures.||percentage of successful treatments|DEBDOX-M1 treatments||Number
652437|NCT02007863|Primary|Number of Successful Unrelated Cord Blood (UCB) Transplants|The number of patients who received successful UCB transplants as evidenced by absolute neutrophil recovery.|2 Years|THERE ARE NO SPECIFIC RESEARCH QUESTIONS IN THIS PROTOCOL. This protocol merely provides UCB as a stem cell treatment modality to pediatric patients who may require it after a conditioning regimen that excludes Total Body Irradiation.Unrelated Cord Blood (UCB) transplant||participants|||Number
652438|NCT02007577|Secondary|Quantification of Insulin Clearance With the Graded Glucose Infusion Test (GGIT)|compare changes in insulin clearance as assessed by the GGIT before and after treatment with salsalate to placebo|one month on treatment|||pmol/min x 4h||95% Confidence Interval|Median
652443|NCT02007434|Secondary|Change From Baseline in Subject Self Rating Scale (SSRS)|The SSRS assesses participant's satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6: where 0 = Extremely dissatisfied, 1 = Dissatisfied, 2 = Slightly dissatisfied, 3 = Neither satisfied nor dissatisfied, 4 = Slightly satisfied, 5 = Satisfied and 6 = Extremely satisfied. A positive change from Baseline indicates improvement.|Baseline and Day 84|Safety analysis set with available data at both time points||units on a scale||Standard Deviation|Mean
652444|NCT02007434|Secondary|Change From Baseline in Patient-Reported Submental Fat Rating Scale (PR-SMFRS)|"The PR-SMFRS is based on the participant's response to the question How much fat do you have under your chin right now? answered on a 5-point ordinal scale (0-4) with 0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat. A negative change from Baseline indicates improvement."|Baseline and Day 84|Safety analysis set with available data at both time points||units on a scale||Standard Deviation|Mean
652445|NCT02007434|Secondary|Change From Baseline in Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)|The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme. A negative change from Baseline indicates improvement.|Baseline and Day 84|Safety analysis set with available data at each time point.||units on a scale||Standard Deviation|Mean
652446|NCT02007434|Primary|Induration Grading Scale Scores|"The following grading system was used for the assessment of induration:
Induration absent to minimal (0)
Induration associated with at least approximately 30% of the treatment area (1)
Induration associated with greater than approximately 30% to at least 60% of the treatment area (2)
Induration covering the entire treatment area but contained within the treatment area (3)
Induration of the neck and face beyond the treatment area (4)"|Day 84|Safety analysis set with available data||units on a scale||Standard Deviation|Mean
652447|NCT02007434|Primary|Bruising Grading Scale Scores|"The following grading system was used for the assessment of bruising:
Bruising absent (0)
Bruising associated with 1 to 3 needle insertion points (1)
Bruising spreading beyond 4 or more individual needle insertion points but contained within the treatment area (2)
Bruising covering the entire treatment area but contained within the treatment area (3)
Bruising of the neck and face beyond the treatment area (4)"|Day 84|Safety analysis set with available data||units on a scale||Standard Deviation|Mean
652448|NCT02007434|Primary|Swelling Grading Scale Scores|"The following grading system was used for the assessment of swelling:
Swelling/edema absent (0)
Minimal swelling/edema contained within treatment area (1)
Modest swelling/edema contained within treatment area (2)
Substantial swelling/edema contained within treatment area (3)
Swelling/edema of the neck and face beyond the treatment area (4)"|Day 84|Safety analysis set with available data||units on a scale||Standard Deviation|Mean
652449|NCT02007434|Primary|Change From Baseline in Pain Assessment Using McGill Pain Questionnaire|Participants rated 15 pain characteristics by using a number to signify how much of that specific type of pain they were experiencing using the Short-Form McGill Pain Questionnaire. The pain characteristic options included Throbbing, Shooting, Stabbing, Sharp, Cramping, Gnawing, Hot-burning, Aching, Heavy, Tender, Splitting, Tiring-exhausting, Sickening, Fearful, and Punishing- cruel. Participants assessed the intensity of each characteristic using the following score system: none (0), mild (1), moderate (2), and severe (3). In addition, present pain was assessed on a scale from 0 (no pain) to 5 (excruciating).|Baseline (predose) and Day 84|Safety analysis set with available data at both time points||units on a scale||Standard Deviation|Mean
652450|NCT02007434|Primary|Change From Baseline in Pain Visual Analog Scale Scores|Participants were provided with a scale 100 mm in length and were asked to mark the place on the line that best represents his or her pain associated with the area treated with study drug. The scale ranged from 0 (no pain) to 100 (most severe pain possible).|Baseline and Day 84|Safety analysis set with available data at both time points||units on a scale||Full Range|Median
652451|NCT02007369|Secondary|Point Prevalence of Self Reported Abstinence for the Previous 7 Days at 6 Months|The outcome was assessed by any self-reported cigarette consumption in the past 7 days at the time of the follow-up. A questionnaire asking smoking status, quitting experience and difficulty in quitting was designed to assess the self reported abstinence for the previous 7 days at 6 months.|6 months|||participants|||Number
652452|NCT02007369|Primary|Self Reported Relapse Rate at 6 Months|Relapse is defined as smoking 5 cigarettes in 3 consecutive days since the most recent quitting. A questionnaire asking smoking status, quitting experience and difficulty in quitting was designed to assess the self reported relapse rate at 6 months.|6-months|||participants|||Number
652453|NCT02007369|Secondary|Point Prevalence of Self Reported Abstinence for the Previous 7 Days at 2 Months|The outcome was assessed by any self-reported cigarette consumption in the past 7 days at the time of the follow-up. A questionnaire asking smoking status, quitting experience and difficulty in quitting was designed to assess the self reported abstinence for the previous 7 days at 2 months.|2 months|||participants|||Number
652454|NCT02007369|Primary|Self Reported Relapse Rate at 2 Months|Relapse is defined as smoking 5 cigarettes in 3 consecutive days since the most recent quitting. A questionnaire asking smoking status, quitting experience and difficulty in quitting was designed to assess the self reported relapse rate at 2 months.|2 months after joining the groups for the social networking services.|||participants|||Number
652455|NCT02007278|Secondary|Number of Patients With Any Adverse Events, Serious Adverse Events and Death||12 weeks|All the randomized patients.||Patients|||Number
652456|NCT02007278|Secondary|Mean Amplitude of Glycemic Excursions (MAGE) for Patients With Hypoglycemia Incidence After 12 Weeks of Treatment|MAGE , which determines the average blood glucose excursions either above or below a value of one standard deviation of the average value of glucose in a given day. MAGE is calculated from the data of continuous tissue glucose monitoring obtained during the measurement period. MAGE is calculated with the formula Σ λ / χ if λ> ν (where λ = changes in blood glucose from peak to nadir, χ = number of valid observations, ν = 1 standard deviation of the mean glucose during a period of 24 hours) from the data of continuous monitoring of the tissue glucose, obtained during the period of measurement. In this endpoint, mean MAGE value is reported for hypo glycemic patients.|12 weeks|Analysis set includes all randomized patients excluding the ones who were prematurely withdrawn and the ones who have no data from visit 7 which required for comparison and had at least one hypoglycemia event.||mg/dL||Standard Deviation|Mean
652460|NCT02007278|Secondary|Glycemic Variability Measured by Total Standard Deviation (TSD)|"Total standard deviation (TSD) or standard deviation of all values of a given measurement period, which has the advantage of being able to include all measured values on a given time period (even several days) through a common and simple statistical concept.
TSD is calculated conventionally with the formula σ = √Σ (Xi - ῦ) 2 / N (where Xi represents each of the values, ῦ represents the population mean and N is the number of observations) from the data of continuous monitoring of tissue glucose obtained during the measurement."|Week 12|Analysis set includes all randomized patients excluding the ones who were prematurely withdrawn and the ones who have no data from visit 7 which required for comparison.||mg/dL||Standard Deviation|Mean
652461|NCT02007278|Secondary|Glycemic Variability Measured by Continuous Overlapping Net Glycemic Action (CONGA)|"Continuous Overlapping Net Glycemic Action (CONGA) which assesses intra-day glycemic variability by calculating the difference between values at different intervals, adjusted according to requirements with the advantage of being highly reproducible.
CONGA is calculated in the conventional way with the formula √tқΣt = t1 (Dt -Ď2) / қ - 1, Ď = tқ Σ Dt t = t1 / қ, Dt = Gt-Gt-m (where қ = Observations with an observation n x 60 minutes, G = glucose measure) from the data of continuous monitoring of tissue glucose obtained during the measurement period."|Week 12|Analysis set includes all randomized patients excluding the ones who were prematurely withdrawn and the ones who have no data from visit 7 which required for comparison.||mg/dL||Standard Deviation|Mean
652462|NCT02007278|Primary|Glycemic Variability Measured by Mean Amplitude of Glucose Excursions (MAGE)|Mean Amplitude of Glycemic Excursions (MAGE) , which determines the average blood glucose excursions either above or below a value of one standard deviation of the average value of glucose in a given day. MAGE is calculated from the data of continuous tissue glucose monitoring obtained during the measurement period. MAGE is calculated with the formula Σ λ / χ if λ> ν (where λ = changes in blood glucose from peak to nadir, χ = number of valid observations, ν = 1 standard deviation of the mean glucose during a period of 24 hours) from the data of continuous monitoring of the tissue glucose, obtained during the period of measurement.|Week 12|Analysis set includes all randomized patients excluding the ones who were prematurely withdrawn and the ones who have no data from visit 7 which required for comparison.||mg/dL||Standard Deviation|Mean
652463|NCT02007252|Primary|Change From Baseline in Abdominal Aortic Aneurysm (AAA) Size Per Year|Size of the AAA was determined using an abdominal ultrasound technique at baseline, 3 months, and 12 months after treatment with study drug. Growth rate (in mm/year) was calculated from the change in AAA size compared to baseline|month 3, month 12|The pharmacodynamic analysis set, which included randomized participants who received at least one dose of study drug, was considered for the analysis. However, only participants with values at each time point were analyzed.||millimeter/year||90% Confidence Interval|Least Squares Mean
652464|NCT02007200|Secondary|The Number of Participants Alive Without Relapse at Last Follow-up|Relapse-free survival will be determined at the last follow-up visit.|Up to 24 months|55 patients were enrolled. 3 patients did not undergo treatment. 13 patients had insufficient tissue and were therefore not evaluable. Only the 39 evaluable patients were included in the analysis.||participants|||Number
652465|NCT02007200|Secondary|The Number of Participants Alive at Follow-up|Overall survival at last follow-up will be determined.|Up to 24 months|55 patients were enrolled. 3 patients did not undergo treatment. 13 patients had insufficient tissue and were therefore not evaluable. Only the 39 evaluable patients were included in the analysis.||participants|||Number
652466|NCT02007200|Primary|Correlations of Tumor p16 Methylation Status With Serum/Saliva Markers of p16, IL6, and VEGF|Each of the tumor and mucosal markers will be dependent variables in repeated measures models that include serum and saliva markers as predictors. Graphical analyses will be used to characterize possible nonlinear relationships between variables. Linear or nonlinear regression, as appropriate, will be used to characterize the relationship between the putative predictors and outcomes. Subset analyses, considering, for example, differences in relationships between tumor markers and serum and saliva markers between smokers and non-smokers will be performed by means of indicator variables.|Up to 12 months|We are seeking additional funding to hire the personnel to perform the serum/saliva markers. Until further notice markers will be unable to be analyzed.|||||
652467|NCT02007200|Primary|Mean Percent Change in p16 Methylation (% CpG Sites Methylated) in Tumor Tissue After Soy Isoflavone|The change in methylation will be analyzed in parallel using a linear repeated measures model. The fixed effects will be time (pre-treatment versus post-treatment), current smoking status (yes or no), their interaction, and tissue type (tumor or not). Satterthwaite's adjustment to the degrees of freedom will be applied to account for heteroscedasticity. The differential effect of soy isoflavone on tumor and non-tumor tissues between smokers and non-smokers will be assessed using linear contrasts.|From baseline to surgery, up to 42 days|55 patients were enrolled. 3 patients did not undergo treatment. 13 patients had insufficient tissue and were therefore not evaluable. Only the 39 evaluable patients were included in the analysis.||Percent change||Full Range|Mean
652468|NCT02007070|Secondary|Overall Survival (OS)|OS is defined as the time from the first day of study treatment to death due to any cause. OS is reported in months.|Up to 2 years|The ATS population consisted of all participants who received at least one dose of study drug.||Months||95% Confidence Interval|Median
652469|NCT02007070|Secondary|Duration of Response (DOR) by RECIST 1.1|DOR is measured from the time measurement criteria are first met for CR/PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded on study). DOR was censored at the last tumor assessment date if a responder did not have PD or death. Non-responders were not included in the analysis. The lower and upper limits were estimated at the time of data cutoff. DOR was analyzed using the Kaplan-Meier method and is reported in weeks.|Up to 2 years|The analysis population consisted of the FAS population (all participants who received at least one dose of study drug and had Baseline data for the analyses that require Baseline data) with confirmed responders.||Weeks||Full Range|Median
652479|NCT02006732|Secondary|FVC AUC0-3h Response (Change From Baseline)|The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within−patient errors and Kenward−Roger approximation of denominator degrees of freedom.|baseline and 12 weeks|Patients from FAS||L||Standard Error|Mean
652470|NCT02007070|Secondary|Progression Free Survival (PFS) by RECIST 1.1|PFS is defined as the time from the first day of study treatment to the first documented disease progression per RECIST 1.1 based on blinded independent central radiologists’ review or death due to any cause, whichever occurs first. Using RECIST 1.1, progressive disease was defined as either a 20% relative increase in the sum of diameters of target lesions, taking as reference the smallest sum on study OR an absolute increase of >5 mm the sum of lesions, OR the appearance of new lesions. PFS was analyzed using the Kaplan-Meier method and is reported in months.|Up to 2 years|The ATS population consisted of all participants who received at least one dose of study drug.||Months||95% Confidence Interval|Median
652471|NCT02007070|Primary|Number of Participants Discontinuing Study Drug Due to AEs|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug, is also an AE.|Up to 2 years|The ATS population consisted of all participants who received at least one dose of study drug.||Participants|||Number
652472|NCT02007070|Primary|Number of Participants Experiencing Adverse Events (AEs)|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug, is also an AE. After discontinuation of study drug, each participant was monitored for a minimum of 30 days for AE monitoring (serious AEs were monitored for up to 90 days after last dose of study drug).|Up to 2 years|The All Treated Set (ATS) population consisted of all participants who received at least one dose of study drug.||Participants|||Number
652473|NCT02007070|Primary|Overall Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1|On-study imaging was to be performed every 9 weeks after the first dose of study drug, or more frequently if clinically indicated. ORR is defined as the proportion of participants in the analysis population who have a Complete Response (CR; disappearance of all target lesions) or Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters).|Up to 2 years|The Full Analysis Set (FAS) population consisted of all participants who received at least one dose of study drug and had Baseline data for the analyses that require Baseline data.||Percentage of Participants||95% Confidence Interval|Number
652474|NCT02006836|Primary|AUCs With/Without Pomelo|Patients of Diabetic 2 group were on CSII treatment with insulin subcutaneous pump.The scheme and dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, followed by 3-day CSII treatment without change of insulin dose. On the 7th test day, patients consumed 100g Majia pomelos after meals (breakfast, lunch and dinner) for 3 test days. Capillary blood samples were detected before and after meals, 10pm, and 3am. Mean of each time point(before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner,10pm, and 3am ) of blood glucose concentrations on 4th to 6th day（without pomelo） were calculated and so as each time point of blood glucose concentrations on 7th to 9th day (with pomelo). Areas under the curves (AUC) of mean blood glucose concentrations of each time point were obtained with/without pomelo.|9 days|||mmol*hour/L||Standard Deviation|Mean
652475|NCT02006836|Primary|∆g of Dinner With/Without Pomelo|"After the dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, there were 3-day CSII treatment without change of insulin dose. Capillary blood samples were detected before and after meals. Glucose difference (∆g) before and after dinner were obtained and analyzed.
g of dinner without pomelo=mean of 3 days of postprandial blood glucose after dinner without pomelo - mean of 3 days of blood glucose before this dinner.
g of dinner with pomelo=mean of 3 days of postprandial blood glucose after dinner with pomelo - mean of 3 days of blood glucose before this dinner."|9 days|||mmol/l||Standard Deviation|Mean
652476|NCT02006836|Primary|∆g of Lunch With/Without Pomelo|"After the dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, there were 3-day CSII treatment without change of insulin dose. Capillary blood samples were detected before and after meals. Glucose difference (∆g) before and after lunch were obtained and analyzed.
g of lunch without pomelo=mean of 3 days of postprandial blood glucose after lunch without pomelo - mean of 3 days of blood glucose before this lunch.
g of lunch with pomelo=mean of 3 days of postprandial blood glucose after lunch with pomelo- mean of 3 days of blood glucose before this lunch."|9 days|||mmol/l||Standard Deviation|Mean
652477|NCT02006836|Primary|∆g of Breakfast With/Without Pomelo|"After the dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, there were 3-day CSII treatment without change of insulin dose. Capillary blood samples were detected before and after meals. Glucose difference (∆g) before and after breakfast were obtained and analyzed.
g of breasfast without pomelo=mean of 3 days of postprandial blood glucose after breakfast - mean of 3 days of blood glucose before this breakfast.
g of breasfast with pomelo=mean of 3 days of postprandial blood glucose after breakfast - mean of 3 days of blood glucose before this breakfast."|9 days|The patients met the inclusion/exclusion criteria and completed the study.||mmol/l||Standard Deviation|Mean
652478|NCT02006836|Primary|Glycemic Index|"Glycemic index (GI) measurement was carried out after an overnight fast on 2 occasions in every subject, each test being separated from the next by a “washout” day.The first test day utilized 50 g of glucose dissolved in 200 ml water followed sequentially by 50g carbohydrate equivalents of the Majia pomelos. Venous blood samples were collected and monitored during 3 hrs for both the healthy and T2DM individuals at 0, 30, 60, 90, 120, 150, and 180 min. Areas under the curves (AUC) of blood glucose concentrations were obtained. The 50 g of glucose was used as the reference (GI = 100) according to the literature. The AUC under the incremental glycemic-response curves for Majia were expressed as a percentage of the areas under the glucose curves for the same subject. The resulting values for all subjects were averaged to calculate the GI.
GI measurement is only calculated in case-control period."|3 days|||percentage of AUC from GI100||Standard Deviation|Mean
652480|NCT02006732|Secondary|TDI Focal Score Based on Combined Dataset From This Study and the Replicate Study NCT01964352|"This endpoint was evaluated after combining the data from this and the replicate study NCT01964352 as specified in the analysis plan. Mahler Transitional Dyspnoea Index (TDI) focal score was performed to measure the effect of the treatment on patients' dyspnoea.(Rating scale of 3 components - change in functional impairment, change in magnitude of tasks, change in magnitude of efforts. Worst score = -9, best score = +9).
The adjusted mean (SE) are obtained from fitting an MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within−patient errors and Kenward−Roger approximation of denominator degrees of freedom."|12 weeks|Patients from FAS after combining the data from this and the replicate study NCT01964352||Units on a scale||Standard Error|Mean
652481|NCT02006732|Secondary|TDI Focal Score Based on Data From This Individual Study|"Mahler Transitional Dyspnoea Index (TDI) focal score was performed to measure the effect of the treatment on patients' dyspnoea.(Rating scale of 3 components - change in functional impairment, change in magnitude of tasks, change in magnitude of efforts. Worst score = -9, best score = +9).
The adjusted mean (SE) are obtained from fitting an MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within−patient errors and Kenward−Roger approximation of denominator degrees of freedom."|12 weeks|Patients from FAS||Units on a scale||Standard Error|Mean
652482|NCT02006732|Secondary|Trough Forced Vital Capacity (FVC) Response (Change From Baseline)|Trough FVC was defined as the FVC value at the end of the dosing interval (24 hours). It was calculated as the mean of the 2 FVC measurements performed 23 h and at 23 h 50 min after inhalation of study medication at day 85. Trough FVC response was defined as trough FVC minus baseline FVC. The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within−patient errors and Kenward−Roger approximation of denominator degrees of freedom.|baseline and 12 weeks|Patients from FAS||L||Standard Error|Mean
652483|NCT02006732|Primary|St. George’s Respiratory Questionnaire (SGRQ) Total Score Based on Combined Dataset From This Study and the Replicate Study NCT01964352|"This endpoint was evaluated after combining the data from this and the replicate study NCT01964352 as specified in the analysis plan. The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life).
The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within−patient errors and Kenward−Roger approximation of denominator degrees of freedom."|12 weeks treatment|Patients from FAS after combining the data from this and the replicate study NCT01964352||units on a scale||Standard Error|Mean
652484|NCT02006732|Primary|St. George’s Respiratory Questionnaire (SGRQ) Total Score Based on Data From This Individual Study|"The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life).
The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within−patient errors and Kenward−Roger approximation of denominator degrees of freedom."|12 weeks treatment|Patients from FAS||units on a scale||Standard Error|Mean
652485|NCT02006732|Primary|Trough FEV1 Response (Change From Baseline)|Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours). It was calculated as the mean of the 2 FEV1 measurements performed 23 h and at 23 h 50 min after inhalation of study medication at day 85. Trough FEV1 response was defines as trough FEV1 minus baseline FEV1. The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within−patient errors and Kenward−Roger approximation of denominator degrees of freedom.|baseline and 12 weeks|Patients from FAS||L||Standard Error|Mean
652486|NCT02006732|Primary|FEV1 AUC0-3h Response|Forced expiratory volume in one second (FEV1) Area under the curve (AUC) 0-3h was calculated as the area under the FEV1-time curve from 0 to 3h post-dose using the trapezoidal rule, divided by the duration (3h) to report in litres. FEV1 AUC0-3h response was defined as FEV1 AUC0-3h minus baseline FEV1. The adjusted mean and standard error (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within−patient errors and Kenward−Roger approximation of denominator degrees of freedom.|baseline and 12 weeks|Patients from the Full Analysis Set (FAS): This patient set included all randomized and treated patients who had a baseline and at least one postbaseline measurement for any of the primary efficacy endpoints.||L||Standard Error|Mean
652487|NCT02006719|Secondary|Investigator Assessment of Improvement With Treatment at Day 95|Investigator assessment of degree of improvement in severity of the participant's treated shoulder compared with screening rated as very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse.|Day 95|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (1 participant excluded); 10 participants also excluded for incomplete questionnaire||participants|||Number
652488|NCT02006719|Secondary|Subject Satisfaction With Treatment at Day 95|Participant assessment of satisfaction with treatment rated as very satisfied, quite satisfied, neither satisfied nor dissatisfied, quite dissatisfied, or very dissatisfied.|Day 95|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (1 participant excluded); 11 participants not completing questionnaire also excluded||participants|||Number
652644|NCT02003404|Primary|Skin Barrier Peel Force|Peel force of barrier materials, comparing peristomal skin to abdominal skin. A portable peel force analyser, previously validated, was used in the clinic to measure peel at 90 degrees to the plane of the body. Peel force was measured on peristomal skin and ipsilateral abdominal skin in the same subject.|4 hours|||grams||Standard Deviation|Mean
652489|NCT02006719|Secondary|Change From Baseline to Day 95 in Adapted ASES Pain Subscale|"Pain subscale score ranging from 0-50, with 0 being greatest pain, derived from participant overall assessment of pain in response to How bad is the pain in your affected shoulder today? using an 11-point NRS where 0=no pain at all and 10=pain as bad as it can be and calculated as (10 - NRS score) x 5; adapted from ASES Standardized Shoulder Assessment Form, Patient Self-Evaluation"|Baseline, day 95|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (1 participant excluded); 33 participants missing either baseline or day 95 pain subscale scores also excluded||units on a scale||Standard Deviation|Mean
652490|NCT02006719|Secondary|Change From Baseline to Day 95 in Passive External Rotation|PROM measurement using a goniometer to assess external rotation in the affected shoulder|Baseline, day 95|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (1 participant excluded); 25 participants missing either baseline or day 95 passive external rotation measurement also excluded||degrees||Standard Deviation|Mean
652491|NCT02006719|Secondary|Change From Baseline to Day 95 in Passive Internal Rotation|PROM measurement using a goniometer to assess internal rotation in the affected shoulder|Baseline, day 95|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (1 participant excluded); 25 participants missing either baseline or day 95 passive internal rotation measurement also excluded||degrees||Standard Deviation|Mean
652492|NCT02006719|Secondary|Change From Baseline to Day 95 in Active External Rotation|AROM measurement using a goniometer to assess external rotation in the affected shoulder|Baseline, day 95|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (1 participant excluded); 25 participants missing either baseline or day 95 active external rotation measurement also excluded||degrees||Standard Deviation|Mean
652493|NCT02006719|Secondary|Change From Baseline to Day 95 in Active Internal Rotation|AROM measurement using a goniometer to assess internal rotation in the affected shoulder|Baseline, day 95|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (1 participant excluded); 25 participants missing either baseline or day 95 active internal rotation measurement also excluded||degrees||Standard Deviation|Mean
652494|NCT02006719|Secondary|Change From Baseline to Day 95 in Passive Abduction|PROM measurement using a goniometer to assess abduction in the affected shoulder|Baseline, day 95|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (1 participant excluded); 25 participants missing either baseline or day 95 passive abduction measurement also excluded||degrees||Standard Deviation|Mean
652495|NCT02006719|Secondary|Change From Baseline to Day 95 in Passive Forward Flexion|Passive range of motion (PROM) measurement using a goniometer to assess forward flexion in the affected shoulder|Baseline, day 95|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (1 participant excluded); 25 participants missing either baseline or day 95 active forward flexion measurement also excluded||degrees||Standard Deviation|Mean
652496|NCT02006719|Secondary|Change From Baseline to Day 95 in Active Abduction|AROM measurement using a goniometer to assess abduction in the affected shoulder|Baseline, day 95|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (1 participant excluded); 25 participants missing either baseline or day 95 active abduction measurement also excluded||degrees||Standard Deviation|Mean
652497|NCT02006719|Secondary|Change From Baseline to Day 95 in Pain With Movement Using 11-point Numeric Rating Scale (NRS)|"Participant assessment of pain in response to How bad is the pain upon movement of your affected shoulder at its worst in the last 24 hours? using an 11-point NRS where 0=no pain at all and 10=pain as bad as it can be."|Baseline, day 95|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (1 participant excluded); 33 participants missing either baseline or day 95 pain with movement scores also excluded||units on a scale||Standard Deviation|Mean
652498|NCT02006719|Secondary|Change From Baseline to Day 95 in Adapted American Shoulder and Elbow Surgeons (ASES) Function Subscale|Function subscale score ranging from 0-50, with 0 being most dysfunctional, derived from participant assessment of ability to do 10 activities with affected shoulder/arm where 0=unable to do to, 1=very difficult to do, 2=somewhat difficult, and 3=not difficult, and calculated as (cumulative total score for the 10 activity items) × (5/3); adapted from ASES Standardized Shoulder Assessment Form, Patient Self-Evaluation (United States adapted version).|Baseline, day 95|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (1 participant excluded); 34 participants missing either baseline or day 95 function subscale scores also excluded||units on a scale||Standard Deviation|Mean
652499|NCT02006719|Primary|Change From Baseline to Day 95 in Active Forward Flexion|Active range of motion (AROM) measurement using a goniometer to assess forward flexion in the affected shoulder|Baseline, day 95|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (1 participant excluded); 25 participants missing either baseline or day 95 active forward flexion measurement also excluded||degrees||Standard Deviation|Mean
652500|NCT02006706|Secondary|Health Assessment Questionnaire-Disability Index (HAQ-DI)|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Week 24|PP Population||score on a scale||Standard Deviation|Mean
652657|NCT02002936|Secondary|Overall Survival|Survived|Up to 3 years|||participants|||Number
652501|NCT02006706|Primary|Change From Baseline Disease Activity Score Based on 28-Joint Count (DAS28) at Week 24|DAS28 was calculated from the number of swollen joints and painful joints using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant-rated arthritis activity assessment using visual analog scale [VAS]) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 less than or equal to (≤)3.2 equals (=) low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity.|Baseline, Week 24|Per Protocol (PP) Population: included all participants who received at least one dose of study drug and who did not have any protocol violations.||score on a scale||Standard Deviation|Mean
652502|NCT02006667|Secondary|Percentage of Participants Achieving Complete Response (CR), Partial Response (PR), or Stable Disease (SD)|Per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1): CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal [(short axis less than (<) 10 millimeters (mm)]. No new lesions. PR was defined as greater than or equal to (≥) 30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. SD was defined as not qualifying for CR, PR, or Progressive Disease (PD).|Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 33 months|FAS||percentage of participants|||Number
652503|NCT02006667|Secondary|Percentage of Participants Surviving at 12 and 24 Months||Screening, and Months 12 and 24|FAS||percentage of participants||95% Confidence Interval|Number
652504|NCT02006667|Secondary|Overall Survival - Time to Event|The median time, in months, from the start of study treatment to OS event.|Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 36 months|FAS||months||95% Confidence Interval|Median
652505|NCT02006667|Secondary|Overall Survival (OS) - Percentage of Participants With an Event|OS was defined as the time from the start of study treatment to date of death due to any cause.|Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 36 months|FAS||percentage of participants|||Number
652506|NCT02006667|Primary|Percentage of Participants Who Were Progression Free at 12 and 24 Months||Screening, and Months 12 and 24|FAS||percentage of participants||95% Confidence Interval|Number
652507|NCT02006667|Primary|Progression-Free Survival - Time to Event|The median time, in months, from the first dose of study treatment to PFS event.|Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 33 months|FAS||months||95% Confidence Interval|Median
652508|NCT02006667|Primary|Progression-Free Survival (PFS) - Percentage of Participants With an Event|PFS was defined as the time from the first dose of study treatment to the first documentation of objective tumor progression or death due to any cause.|Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 33 months|FAS||percentage of participants|||Number
652509|NCT02006407|Secondary|Evaluate the Correlation Between Global COGState Scores, Radiation Dose, and the Perpendicular Diffusivity of Water as Measured by Diffusion Tensor Imaging at 6 Months|Determine the change in cognitive test scores from baseline, at 6 months using CogState (a computerized software testing system that offers various cognitive assessments based on expansive neurocognitive tests). Correlate test scores from COGState with changes in Diffusion Tensor Imaging (DTI) at the same timepoints (Baseline and 6 months) using scatter plots with Pearson and Spearman's correlation coefficients. As a pilot study multiple comparisons will be assessed; however, the working hypothesis based upon results in adults treated with radiation therapy is that DTI changes as measured by an increase in diffusivity of water perpendicular to the direction of axonal transport will correlate with changes in global response as measured on COGState with the sub-domains on executive function most highly correlated. In addition, these regional changes in DTI will be directly related to the radiation doses received in these regions.|6 months|Data can not be accessed due to technical difficulties with the COGState server.|||||
652510|NCT02006407|Secondary|Evaluate the Correlation Between Global COGState Scores and the Perpendicular Diffusivity of Water by Diffusion Tensor Imaging at Baseline, 3 Weeks, and 6 Weeks Into Treatment.|Determine the change in cognitive test scores from baseline to time-points early during radiation therapy (3 and 6 weeks) using CogState (a computerized software testing system that offers various cognitive assessments based on expansive neurocognitive tests). Correlate test scores from COGState with changes in Diffusion Tensor Imaging (DTI) at the same timepoints using scatter plots with Pearson and Spearman's correlation coefficients. As a pilot study multiple comparisons will be assessed; however, the working hypothesis is that DTI changes as measured by an increase in diffusivity of water perpendicular to the direction of axonal transport will be measurable even in this acute setting and will correlate with global response as measured on COGState with the sub-domains on executive function anticipated to be most highly correlated.|Baseline, 3 weeks, and 6 weeks|Data can not be accessed due to technical difficulties with the COGState server.|||||
652511|NCT02006407|Primary|Evaluate the Change From Baseline in Perpendicular Diffusivity of Water as Measured by Diffusion Tensor Imaging (DTI) at 3 Weeks and at 6 Weeks Post Radiation Therapy.|Descriptive statistics and plots will be used to determine Diffusion Tensor Imaging (DTI) parameters for various regions in the brain. The mean (across subject) change in DTI parameter for a given region, at a given time, will be used to assess white matter injury.|Baseline, 3 weeks, and 6 weeks|Because the outcome measure was CHANGE FROM BASELINE to 3 and 6 weeks, and data were not able to be collected at 3 and 6 weeks, the outcome measure could not be analyzed|||||
652512|NCT02006342|Secondary|Number of Participants Who Developed Hypoglycemia|"To determine whether it is safe to administer both IV and subcutaneous insulin, it is important to assure that patient's glucose does not drop to critically low level and lead to adverse events. Hypoglycemia was defined as less than or equal to 60mg/dL during 24 hours after anion gap closure.
Anion Gap is a measure of acidosis that results from decompensated Diabetes Mellitus. Acidosis is the result of the body being unable to utilize glucose for energy production and instead uses fatty acid metabolism resulting in ketone formation. Anion Gap is a surrogate measure for the level of ketones resulting in the excess acid production."|Participants monitored during the 24 hours after anion gap closure|While one participant in the glargine group did not receive glargine, all who were enrolled were analyzed (intention to treat analysis).||participants|||Number
652513|NCT02006342|Secondary|Hospital Length of Stay|Hospital length of stay was determined to assess whether a more efficient correction of the acidosis will result in decreased time that the patient is admitted to the hospital. Results reported are adjusted for age, hospital site, and etiology of diabetic ketoacidosis.|Participants monitored from hospital admission to discharge, an average of 4 days|While one participant in the glargine group did not receive glargine, all who were enrolled were analyzed (intention to treat analysis).||days||Standard Error|Mean
652514|NCT02006342|Secondary|Intensive Care Unit Length of Stay|Determine the amount of time patient is admitted to the intensive care unit with the goal of assessing if more efficient correction of the acidosis results in decreased time in the intensive care unit for the patients.|Participants monitored from hospital admission to discharge, an average of 4 days|While one participant in the glargine group did not receive glargine, all who were enrolled were analyzed (intention to treat analysis).||days||Inter-Quartile Range|Median
652515|NCT02006342|Secondary|Number of Participants Admitted to the ICU|The goal was to determine if the amount of patients admitted to the ICU could be reduced by providing more efficient resolution of the critical condition which is the acidosis.|Participants followed for the duration of the Emergency Department stay, an expected average of 12 hours|While one participant in the glargine group did not receive glargine, all who were enrolled were analyzed (intention to treat analysis).||participants|||Number
652516|NCT02006342|Primary|Time to Anion Gap Closure|Anion Gap is a measure of acidosis that results from decompensated Diabetes Mellitus. Acidosis is the result of the body being unable to utilize glucose for energy production and instead uses fatty acid metabolism resulting in ketone formation. Anion Gap is a surrogate measure for the level of ketones resulting in the excess acid production. Results reported are adjusted for initial anion gap, etiology of diabetic ketoacidosis, and comorbidities.|Participants monitored from hospital admission to discharge, an average of 4 days|While one participant in the glargine group did not receive glargine, all who were enrolled were analyzed (intention to treat analysis).||hours||Standard Error|Mean
652517|NCT02006108|Secondary|Correlation of Cell-bound Iron Quantities on QSM Sequences With Macrophage and Iron Stains on Histopathology|To evaluate our ability to quantify cell-bound iron using the novel QSM sequence, we use histopathological data showing 1) the iron content of renal tissue sampled, and 2) the level of macrophage infiltration of the renal tissue. We will perform iron and macrophage stains in biopsy tissues in order to determine this.|3 weeks|CD163 positive macrophages||correlation coefficient|||Number
652518|NCT02006108|Primary|Radiologically Detectable Differences in Signal Intensity Between Healthy and Rejected Kidneys, Measured Using T2* Maps|According to the study hypothesis, macrophage infiltration into rejected kidneys will be significantly greater than in healthy kidneys; since macrophages are expected to phagocytose injected iron, there should be a detectable difference in signal intensity between healthy and rejected organs. This can be evaluated using semiquantitative T2* maps.|24 hours to 7 days|T2* value of transplant kidney||ms (delayed postcontrast scans)||Standard Deviation|Mean
652519|NCT02005692|Primary|Turn Protocol Compliance|The primary clinical efficacy endpoint is to assess the change in turning protocol compliance after implementation of the DynaSense system.|Subjects will be followed for the length of hospital stay which is expected to average 5 days.|||percentage turn compliance||95% Confidence Interval|Number
652520|NCT02005692|Primary|Safety Primary Endpoint|The safety primary endpoint is to assess safety by documenting the number, type, and severity of side effects and adverse events.|Subjects will be followed for the length of hospital stay which is expected to average 5 days, or until resolution of ADE.|||percentage of subjects with ADEs|||Number
652521|NCT02005601|Secondary|Nausea Severity|Nausea severity measured using Likert scale ranging from 0 (none) to 10 (severe).|POD 1|||units on a scale||Standard Deviation|Mean
652522|NCT02005601|Secondary|Total Daily Opioid Use (mg Oral Morphine Equivalents)|Total daily opioid use (including PO, PCEA, IV, subcutaneous, IV push) in mg oral morphine equivalents on POD 1.|POD 1|||mg oral morphine equivalents||Standard Deviation|Mean
652523|NCT02005601|Primary|NRS Pain With Ambulation at 2 Weeks|When considering the pain in the knee in which you are having/had surgery, on a scale of 0-10, with 0 being no pain and 10 being pain as bad as you can imagine, how would you describe your level of pain in the last 24 hours during ambulation?|2 weeks after surgery|||NRS pain score||Standard Deviation|Mean
652524|NCT02005562|Secondary|Participant Survival|Participants survival was defined as the percentage of participants living with or without a functioning graft between Weeks 0 and 52. Participants were censored at the date of last treatment, date of last contact or withdrawal, and date of death.|Day 0, Weeks 2, 4, 6, 12, 16, 26, 39, and 52|ITT population||percentage of participants|||Number
652525|NCT02005562|Secondary|Time to Graft Loss|The median time, in days, from randomization to graft loss event. Participants were censored at the date of last treatment, date of last contact or withdrawal, and date of death.|Day 0, Weeks 2, 4, 6, 12, 16, 26, 39, and 52|ITT population||days||Full Range|Median
652526|NCT02005562|Secondary|Graft Loss - Percentage of Participants With an Event|Graft loss was defined as physical loss (nephrectomy), functional loss [necessitating maintenance dialysis for greater than (>)8 weeks], retransplant or death. Participants were censored at the date of last treatment, date of last contact or withdrawal, and date of death.|Day 0, Weeks 2, 4, 6, 12, 16, 26, 39, and 52|ITT population||percentage of participants|||Number
652527|NCT02005562|Secondary|Graft Histology - Percentage of Participants With at Least One Chronic Graft Nephropathy at Week 12 and Week 52|Participants were censored at the date of last treatment, date of last contact or withdrawal, and date of death.|Weeks 12 and 52|ITT population||percentage of participants|||Number
652528|NCT02005562|Secondary|Graft Histology - Percentage of Participants With at Least One Borderline Lesion at Week 12 and Week 52|Participants were censored at the date of last treatment, date of last contact or withdrawal, and date of death.|Weeks 12 and 52|ITT population||percentage of participants|||Number
652529|NCT02005562|Secondary|Percentage of Participants With at Least One BPAR at Week 12 and Week 52|BPAR was defined as the presence of clinical signs and kidney biopsy that confirmed the rejection before Week 12. Participants were censored at the date of last treatment, date of last contact or withdrawal, and date of death.|Weeks 12 and 52|ITT population; only participants with at least one assessed biopsy were included in the analysis.||percentage of participants|||Number
652658|NCT02002936|Secondary|Cytogenetic Response Ratio According to IWG 2006 Criteria|NCA (not considered assessable): no cytogenetic response|Up to 3 years|||participants|||Number
652530|NCT02005562|Secondary|Time to Occurrence of First BPAR Between Day 0 and Week 52|BPAR was defined as the presence of clinical signs and kidney biopsy that confirmed the rejection before Week 12. Subclinical acute rejection at Week 12 was included in the analysis. Subclinical acute rejection was defined as an increase of serum creatinine at Week 12 strictly less than 10% compared to BL values and BPAR of Grade ≥1 according to Banff 1997 classification at Week 12. The occurrence of the first BPAR was defined as the time from randomization to the first recorded BPAR between Day 0 and Week 52. The results of protocol biopsies at Week 12 were taken into account. Participants were censored at the date of last treatment, date of last contact or withdrawal, and date of death.|Day 0, Weeks 2, 4, 6, 12, 16, 26, 39, and 52|ITT population||days||95% Confidence Interval|Median
652531|NCT02005562|Secondary|Time to Occurrence of First BPAR Between Day 0 and Week 52 - Percentage of Participants With an Event|BPAR was defined as the presence of clinical signs and kidney biopsy that confirmed the rejection before Week 12. Subclinical acute rejection at Week 12 was included in the analysis. Subclinical acute rejection was defined as an increase of serum creatinine at Week 12 strictly less than 10% compared to BL values and BPAR of Grade ≥1 according to Banff 1997 classification at Week 12. The occurrence of the first BPAR was defined as the time from randomization to the first recorded BPAR between Day 0 and Week 52. The results of protocol biopsies at Week 12 were taken into account. Participants were censored at the date of last treatment, date of last contact or withdrawal, and date of death.|Day 0, Weeks 2, 4, 6, 12, 16, 26, 39, and 52|ITT population||percentage of participants|||Number
652532|NCT02005562|Secondary|Creatinine Clearance Values Estimated With the Modification of Diet in Renal Disease (MDRD) Simplified Equation|The mean creatinine clearance values at Weeks 2, 4, 6, 12, 16, 26, 39, and 52 estimated using the MDRD simplified equation. For males, the MDRD simplified equation was defined as MDRD (mL/min/1.73 square meters [m^2]) =186 multiplied by (*) serum creatinine in mg/L raised to the power of (^) -1.154 * age ^ -0.203. For females, the MDRD simplified equation was defined as MDRD (mL/min/1.73 m^2) = males formula * 0.742.|Weeks 2, 4, 6, 12, 16, 26, 39, and 52|ITT population; n=number of participants assessed for the specified parameter at a given visit.||mL/min/1.73 m^2||Standard Deviation|Mean
652533|NCT02005562|Secondary|Creatinine Clearance Values Estimated With the Cockcroft-Gault Equation (Milliliters Per Minute [mL/Min])|The mean creatinine clearance values at Weeks 2, 4, 6, 12, 16, 26, 39, and 52 estimated using the Cockcroft-Gault equation.|Weeks 2, 4, 6, 12, 16, 26, 39, and 52|ITT population; n=number of participants assessed for the specified parameter at a given visit.||mL/min||Standard Deviation|Mean
652534|NCT02005562|Secondary|Serum Creatinine Values [Micromoles Per Liter (µmol/L)]|The mean serum creatinine values at Weeks 2, 4, 6, 12, 16, 26, 39, and 52.|Weeks 2, 4, 6, 12, 16, 26, 39, and 52|ITT population; number (n) = number of participants assessed for the specified parameter at a given visit.||µmol/L||Standard Deviation|Mean
652535|NCT02005562|Primary|Percentage of Participants With Biopsy-Proven Acute Rejection (BPAR) Before Week 12 or Acute Subclinical Rejection on Protocol Biopsy at Week 12|BPAR was defined as the presence of clinical signs and kidney biopsy that confirmed the rejection before Week 12. Subclinical acute rejection was defined as an increase of serum creatinine at Week 12 strictly less than 10 percent (%) compared to baseline (BL) values and BPAR of Grade greater than or equal to (≥) 1 according to Banff 1997 classification at Week 12.|Week 12|ITT population; only participants with available protocol biopsy at Week 12 and/or a BPAR before Week 12 were included in the analysis.||percentage of participants|||Number
652536|NCT02005549|Secondary|Percentage of Participants Undergoing Breast-Conserving Surgery|Percentage of participants undergoing a breast-conserving procedure versus a modified radical mastectomy at final surgery, performed 2 to 4 weeks after the last chemotherapy cycle (Week 18)|20-24 weeks (final surgery, performed 2 to 4 weeks after the last chemotherapy cycle [Week 18])|ITT population.||percentage of participants||95% Confidence Interval|Number
652537|NCT02005549|Secondary|Percentage of Participants With pCR, Clinical Complete Response (CR), or Clinical Partial Response (PR)|Percentage of participants with pCR plus the percentage of participants without pCR who achieved CR or PR as measured by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal (short axis less than [<] 10 millimeters [mm]). No new lesions. PR was defined as greater than or equal to (≥) 30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.|Baseline, 20-24 weeks (final surgery, performed 2 to 4 weeks after the last chemotherapy cycle [Week 18])|ITT population; participants evaluable for response included those participants who received a minimum of 3 cycles of treatment (9 weeks on study) with final surgery performed and the samples and reports available.||percentage of participants||95% Confidence Interval|Number
652538|NCT02005549|Primary|Percentage of Participants With Pathological Complete Response (pCR)|pCR was defined as the absence of signs for invasive tumor in the final surgical sample as judged by the local pathologist. Surgery was performed 2 to 4 weeks after the last chemotherapy cycle.|Baseline, 20-24 weeks (final surgery, performed 2 to 4 weeks after the last chemotherapy cycle [Week 18])|ITT population; participants evaluable for response included those participants who received a minimum of 3 cycles of treatment (9 weeks on study) with final surgery performed and the samples and reports available.||percentage of participants||95% Confidence Interval|Number
652539|NCT02005536|Secondary|Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Booster Vaccination With IMOVAX POLIO®|Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Fever, Headache, Malaise, Myalgia. Grade 3 was defined as incapacitating, unable to perform usual activities for Pain; diameter ≥ 50 mm for Erythema and Swelling; Temperature ≥ 39.0°C for Fever; and significant, prevents daily activity for Headache, Malaise, and Myalgia.|Day 0 up to Day 7 post-vaccination|Solicited injection site and systemic reactions were assessed in all participants who received study vaccine (Safety Analysis Set).||Number of participants|||Number
652540|NCT02005536|Secondary|Geometric Mean of Individual Titer Ratios of Vaccine Antigens Following Booster Vaccination With IMOVAX POLIO®|Anti-polio virus anti-bodies were assessed by virus neutralization assay. The geometric mean titer ratio is the post-booster to pre-booster geometric mean ratio values.|Day 28 post-booster vaccination|Geometric mean of individual titer ratios were assessed in the per-protocol analysis set.||Titer Ratio||95% Confidence Interval|Geometric Mean
652541|NCT02005536|Secondary|Percentage of Participants With Seroprotection Against Polio Antigens Before and After Booster Vaccination With IMOVAX POLIO®|Seroprotection was defined as a titer of ≥ 8 (1/dil) pre-booster or post-booster vaccination. Anti-polio virus antibodies were assessed by virus neutralization assay|Day 0 (pre-booster vaccination) and Day 28 post-booster vaccination|Anti-polio booster response was assessed in the per-protocol analysis set.||Percentage of participants|||Number
652542|NCT02005536|Secondary|Geometric Mean Titers of Vaccine Antigens Before and After Vaccination With IMOVAX POLIO®|Anti-polio virus antibodies were assessed by virus neutralization assay.|Day 0 (pre-booster vaccination) and Day 28 post-booster vaccination|Geometric mean titers was assessed in the per-protocol analysis set.||Titers||95% Confidence Interval|Geometric Mean
652543|NCT02005536|Primary|Percentage of Participants With Booster Responses Against Polio Antigens Following Vaccination With IMOVAX POLIO®|A booster response was defined as a 4-fold increase from pre-booster to post-booster vaccination. Anti-polio virus antibodies were assessed by virus neutralization assay.|Day 28 post-vaccination|Anti-polio booster response was assessed in the per-protocol analysis set.||Percentage of participants|||Number
652544|NCT02005484|Secondary|Time to Progression|Time to progression was defined as the time, in months, from the date of study entry to the date of disease progression or death due to any cause. If a participant's date of disease progression or death was unknown, or had not occurred, the last date of examination, treatment, and follow-up dates were included in the analysis.|Weekly throughout the study|ITT population||months||Full Range|Median
652545|NCT02005484|Secondary|Time to Progression - Number of Participants With an Event|Time to progression was defined as the time, in months, from the date of study entry to the date of disease progression or death due to any cause. If a participant's date of disease progression or death was unknown, or had not occurred, the last date of examination, treatment, and follow-up dates were included in the analysis.|Weekly throughout the study|ITT population||participants|||Number
652546|NCT02005484|Secondary|Overall Survival|Overall survival (OS) was defined as the time, in months, from the date of study entry to the date of the death due to any cause. If a participant's date of death was unknown, or had not occurred, the last date of examination, treatment, and follow-up dates were included in the analysis.|Weekly throughout the study|ITT population||months||Full Range|Median
652547|NCT02005484|Secondary|Overall Survival - Number of Participants Who Died|OS was defined as the time, in months, from the date of study entry to the date of the death due to any cause. If a participant's date of death was unknown, or had not occurred, the last date of examination, treatment, and follow-up dates were included in the analysis.|Weekly throughout the study|ITT population||participants|||Number
652548|NCT02005484|Secondary|Percentage of Participants With a Best Overall Response of CR or PR|Tumor response assessed according to RECIST. CR: complete disappearance of all target and non-target lesions, with exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm); no new lesions. PR: ≥30% decrease under baseline of sum of diameters of all target lesions. Short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions; no unequivocal progression of non-target disease; no new lesions.|Weekly throughout the study|ITT population||percentage participants|||Number
652549|NCT02005484|Secondary|Percentage of Participants With Clinical Benefit|Participants were classified as having a clinical benefit if they had a best overall tumor response of CR, PR, or SD. Tumor response assessed according to RECIST. CR: complete disappearance of all target and non-target lesions, with exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm); no new lesions. PR: ≥30% decrease under baseline of sum of diameters of all target lesions. Short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions; no unequivocal progression of non-target disease; no new lesions. Stable SD: not qualifying for CR, PR, or PD.|Weekly throughout the study|ITT population||percentage participants|||Number
652550|NCT02005484|Primary|Percentage of Participants With a Response by Response Evaluation Criteria In Solid Tumors (RECIST) Category|Tumor response assessed according to RECIST. Complete response (CR): complete disappearance of all target and non-target lesions, with exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than [<]10 millimeters [mm]); no new lesions. Partial response (PR): greater than or equal to (≥)30 percent (%) decrease under baseline of sum of diameters of all target lesions. Short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions; no unequivocal progression of non-target disease; no new lesions. Stable disease (SD): not qualifying for CR, PR, or progressive disease (PD). Participants who could not be classified per RECIST were allocated as follows: early death from malignant disease (death due to cancer), early death because of other cause (death not related to toxicity or cancer disease), and unknown (for not fitting into the above categories).|Weekly throughout study|ITT population||percentage of participants|||Number
652551|NCT02005393|Primary|Image Quality Scores Using Likert Scale|"Likert score ratings of image quality for FICE and NBI images. Each FICE setting was compared to NBI, to determine which FICE settings were equivalent to NBI.
Likert Scores:
Not seen;
poor but usable, characteristic features are detectable but details are not fully reproduced; features just visible;
good; allows an adequate assessment, details of anatomical structures are visible but not necessarily clearly defined; details emerging;
very good; allows an excellent assesssment, anatomical details are clearly defined; details clear"|One day|All patients had imaging done with both FICE, immediately followed by NBI. Images for one subject were not included in the Reader Study due to an error on the Compact Flash card which resulted in three (3) corrupt FICE images (FICE settings 0, 1 & 2); therefore making 19 out of 20 participants analyzed.||units on a scale||Standard Deviation|Mean
652552|NCT02005211|Primary|Safety - Adverse Events|Safety - Number of subjects reporting any adverse events during the study|Day of first dose to follow up|Safety||Participants|||Number
652553|NCT02005211|Secondary|Biomarker|Biomarker (Abeta 1-40; A beta 1-42) % change from baseline|Pre dose vs Day 14|Pharmacodynamic||% change from baseline||Standard Deviation|Mean
652554|NCT02005211|Secondary|PK AUC - Overall Study (SAD & MAD Parts)|Pharmacokintic Area Under the Curve (0 to t)|0,0.5,1,2,3,4,8,12,24,48 hr single dose, multiple dose does not include 48 hr|healthy Japanese participants||hr.ng/mL||Geometric Coefficient of Variation|Geometric Mean
652555|NCT02005211|Secondary|PK Cmax - Overall Study|Pharmacokinetic maximum concentration|0, 0.5,1,2,3,4,8,12,24,48 hr single dose, multiple dose does not include 48 hr|Pharmacokinetic||ng/mL||Geometric Coefficient of Variation|Geometric Mean
652556|NCT02005029|Secondary|Mean Cmax of Plasma Levodopa After Erythromycin Versus Placebo|Mean Cmax of plasma levodopa after erythromycin versus placebo. Plasma samples were collected at the following times post-levodopa dose: 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, and 240 minutes.|2 weeks, between visits 2 and 3|Of the original ten participants; one participant's data was excluded due to symptomatic orthostasis which likely confounded her results, one participant was withdrawn early due to noncompliance, and one participant had undetectable plasma levodopa levels throughout the study and was thus excluded from the pharmacokinetic analysis.||ng/mL||Standard Deviation|Mean
652557|NCT02005029|Secondary|MDS-UPDRS Part 3 (Movement Disorders Society- Unified Parkinson's Disease Rating Scale)|Part 3 of this scale is a standardized physical assessment that quantifies the total burden of motor symptoms in Parkinson's disease patients. Each of the 18 items on the scale is rated from 0 (none, 1 (slight), 2 (mild), 3 (moderate) and 4 (severe). Scores range from 0-72. Higher scores represent a more severe burden of motor symptoms (a worse outcome).|2 weeks, between visits 2 and 3|One participant's data was excluded due to symptomatic orthostasis which likely confounded her results and one participant was withdrawn early due to noncompliance.||units on a scale||Standard Deviation|Mean
652558|NCT02005029|Secondary|Change in Dyskinesia|Mean total AIMS (Abnormal Involuntary Movements Scale) score after receiving erythromycin minus mean total AIMS score after receiving placebo. The AIMS test has a total of twelve items rating involuntary movements of various areas of the patient's body. Ten of the items are rated on a five-point scale of severity from 0–4. The scale is rated from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe). Two of the items are not scored. Total score range is from 0 to 40. Higher scores represent more severe dyskinesia (a worse outcome).|2 weeks, between visits 2 and 3|Of the original 10 participants, one participant's data was excluded due to symptomatic orthostasis which likely confounded her results and one participant was withdrawn early due to noncompliance.||units on a scale||Standard Deviation|Mean
652559|NCT02005029|Secondary|Timed up and go Test (TUAG) Fast Speed|Change in motor function as assessed by timed up and go test (fast speed). This test measures the total time to stand from a chair, walk 10 feet, and return to sitting.|2 weeks, between visits 2 and 3|Of the original 10 participants, one participant's data was excluded due to symptomatic orthostasis which likely confounded her results and one participant was withdrawn early due to noncompliance.||seconds||Standard Deviation|Mean
652560|NCT02005029|Secondary|Timed up and go Test (TUAG) Comfortable Speed|Change in motor function as assessed by timed up and go test (comfortable speed). This test measures the total time to stand from a chair, walk 10 feet, and return to sitting.|2 weeks, between visits 2 and 3|Of the original 10 participants, one participant's data was excluded due to symptomatic orthostasis which likely confounded her results and one participant was withdrawn early due to noncompliance.||seconds||Standard Deviation|Mean
652561|NCT02005029|Secondary|Comfortable 20 Feet Gait Speed (CGS)|Change in motor function as assessed by comfortable 20 feet gait speed (CGS)|2 weeks, between visits 2 and 3|Of the original 10 participants, one participant's data was excluded due to symptomatic orthostasis which likely confounded her results and one participant was withdrawn early due to noncompliance.||seconds||Standard Deviation|Mean
652562|NCT02005029|Secondary|Five Times Sit-to-stand Test|Change in motor function as measured by Five times sit-to-stand test. This test measures the total time to complete 5 repetitions of sit to stand.|2 weeks, between visits 2 and 3|Of the original 10 participants, one participant's data was excluded due to symptomatic orthostasis which likely confounded her results and one participant was withdrawn early due to noncompliance.||seconds||Standard Deviation|Mean
652563|NCT02005029|Secondary|9-hole Peg Test Left Hand|Change in motor function as assessed by 9-hole peg test for upper extremity manipulation/dexterity. This test measures the total time required to place and remove 9 holes in a pegboard. Each hand is tested separately.|2 weeks, between visits 2 and 3|Of the original 10 participants, one participant's data was excluded due to symptomatic orthostasis which likely confounded her results and one participant was withdrawn early due to noncompliance.||seconds||Standard Deviation|Mean
652564|NCT02005029|Secondary|9-hole Peg Test Right Hand|Change in motor function as assessed by 9-hole peg test for upper extremity manipulation/dexterity. This test measures the total time required to place and remove 9 holes in a pegboard. Each hand is tested separately.|2 weeks, between visits 2 and 3|Of the original 10 participants, one participant's data was excluded due to symptomatic orthostasis which likely confounded her results and one participant was withdrawn early due to noncompliance.||seconds||Standard Deviation|Mean
652565|NCT02005029|Primary|Area Under the Curve 0-4 Hours for Plasma Levodopa After Erythromycin Versus Placebo|Mean Area under the Curve 0-4 hours for plasma levodopa after erythromycin versus placebo. Plasma samples were collected at the following times post-levodopa dose: 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, and 240 minutes.|2 weeks, between visits 2 and 3|Of the original ten participants; one participant's data was excluded due to symptomatic orthostasis which likely confounded her results, one participant was withdrawn early due to noncompliance, and one participant had undetectable plasma levodopa levels through out the study and was thus excluded from the pharmacokinetic analysis.||ng/mL*min||Standard Deviation|Mean
652566|NCT02005029|Primary|Gastric Emptying Time|Mean gastric emptying time in minutes as measured by SmartPill|2 weeks, between visits 2 and 3|Of the original ten participants; one participant's data was excluded due to symptomatic orthostasis which likely confounded her results, one participant was withdrawn early due to noncompliance, and four participants were unable to complete a SmartPill evaluation.||minutes||Standard Deviation|Mean
652567|NCT02004990|Secondary|Dental Plaque Composition Measured by Numbers of Bacteria Present|Dental plaque is a multispecies bacterial biofilm and the specific bacteria populating this biofilm will be measured. Measurement will be change in thickness of the biofilm|2-4 weeks|||micrometers||Standard Deviation|Mean
652568|NCT02004990|Primary|Dental Plaque Levels Measures on Scale of 0-2|Modified plaque index for the mixed dentition scale is 0-2 (0=best 2=worse)|2-4 weeks|||units on a scale||Standard Deviation|Mean
652581|NCT02004873|Secondary|Ventricular Capture Management Threshold|Subjects that have a ventricular capture management threshold (VCMT) that is within 0.5 Volts of the manual (auto decrement) PCT (at 0.24 ms pulse width) at the 6-month post-implant visit. The VCMT is an automatically measured pacing capture threshold that is measured by the Micra device’s pacing algorithm. In contrast, the manual (auto decrement) pacing capture threshold is measured by the clinician during a study visit.|6 Months Post Implant|Subjects implanted with Micra who had paired ventricular capture management PCT and auto decrement PCT data available at the 6-month visit.||participants|||Number
652569|NCT02004886|Secondary|Change From Baseline in 3-hour Insulin Total AUC at Week 4|Blood samples were collected for insulin 30 minutes prior to the breakfast meal and 15, 30, 60, 90, 120, 180 minutes post-meal. AUC is a measure of the amount of drug in the blood over time. 3-hour Insulin Total AUC was measured at Baseline and at Week 4. The change from baseline was defined as the Week 4 value minus the Baseline value.|Baseline and Week 4|Completers Population was used for all efficacy analyses, and required that a participant took at least one dose of study therapy, had a baseline measurement, and had a post-randomization measurement in the treatment period at Week 4.||µIU hr/mL||95% Confidence Interval|Least Squares Mean
652570|NCT02004886|Secondary|Change From Baseline in 3-hour AUC for C-peptide at Week 4|Blood samples were collected for C-peptide 30 minutes prior to the breakfast meal and 15, 30, 60, 90, 120, 180 minutes post-meal. AUC is a measure of the amount of drug in the blood over time. 3-hour AUC for C-peptide was measured at Baseline and at Week 4. The change from baseline was defined as the Week 4 value minus the Baseline value.|Baseline and Week 4|Completers Population was used for all efficacy analyses, and required that a participant took at least one dose of study therapy, had a baseline measurement, and had a post-randomization measurement in the treatment period at Week 4.||ng hr/mL||95% Confidence Interval|Least Squares Mean
652571|NCT02004886|Secondary|Change From Baseline in 3-hour Area Under the Plasma Concentration Versus Time Curve (AUC) for Glucose at Week 4|Blood samples collected for glucose 30 minutes prior to the breakfast meal and 15, 30, 60, 90, 120, 180 minutes post-meal. AUC is a measure of the amount of drug in the blood over time. 3-hour AUC for Glucose was measured at Baseline and at Week 4. The change from baseline was defined as the Week 4 value minus the Baseline value.|Baseline and Week 4|Completers Population was used for all efficacy analyses, and required that a participant took at least one dose of study therapy, had a baseline measurement, and had a post-randomization measurement in the treatment period at Week 4.||mg hr/dL||95% Confidence Interval|Least Squares Mean
652572|NCT02004886|Secondary|Change From Baseline in 2-hour Post-prandial Glucose Excursion at Week 4|2-hour post-prandial glucose excursion is the change in glucose concentration in the blood 2 hours after a meal. Change from baseline in 2-hour post-prandial glucose excursion at Week 4 is defined as Week 4 minus baseline.|Baseline and Week 4|Completers Population was used for all efficacy analyses, and required that a participant took at least one dose of study therapy, had a baseline measurement, and had a post-randomization measurement in the treatment period at Week 4.||mg/dL||95% Confidence Interval|Least Squares Mean
652573|NCT02004886|Secondary|Change From Baseline in Fasting Insulin at Week 4|Fasting insulin levels in the blood were measured at Baseline and at Week 4. The change from baseline was defined as the Week 4 value minus the Baseline value.|Baseline and Week 4|Completers Population was used for all efficacy analyses, and required that a participant took at least one dose of study therapy, had a baseline measurement, and had a post-randomization measurement in the treatment period at Week 4.||μIU/mL||95% Confidence Interval|Least Squares Mean
652574|NCT02004886|Secondary|Change From Baseline in Fasting C-peptide at Week 4|Fasting C-peptide levels in the blood were measured at Baseline and at Week 4. The change from baseline was defined as the Week 4 value minus the Baseline value.|Baseline and Week 4|Completers Population was used for all efficacy analyses, and required that a participant took at least one dose of study therapy, had a baseline measurement, and had a post-randomization measurement in the treatment period at Week 4.||ng/mL||95% Confidence Interval|Least Squares Mean
652575|NCT02004886|Secondary|Change From Baseline in Fructosamine at Week 4|Fructosamine levels in the blood were measured at Baseline and at Week 4. The change from baseline was defined as the Week 4 value minus the Baseline value.|Baseline and Week 4|Completers Population was used for all efficacy analyses, and required that a participant took at least one dose of study therapy, had a baseline measurement, and had a post-randomization measurement in the treatment period at Week 4.||mg/dL||95% Confidence Interval|Least Squares Mean
652576|NCT02004886|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|Plasma Glucose levels were measured at Baseline and at Week 4. The change from baseline was defined as the Week 4 value minus the Baseline value.|Baseline and Week 4|Completers Population was used for all efficacy analyses, and required that a participant took at least one dose of study therapy, had a baseline measurement, and had a post-randomization measurement in the treatment period at Week 4.||mg/dL||95% Confidence Interval|Least Squares Mean
652577|NCT02004886|Primary|Number of Participants Discontinuing Study Treatment Due to an AE|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.|Up to 28 days|Safety Population included all randomized participants who initiated study therapy.||Number of Participants|||Number
652578|NCT02004886|Primary|Number of Participants Experiencing an Adverse Event (AE)|An adverse event (AE) is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.|Up to 42 days|Safety Population included all randomized participants who initiated study therapy.||Number of Participants|||Number
652579|NCT02004886|Primary|Change From Baseline in 24-hour Weighted Mean Glucose (WMG) at Week 4|Blood samples were collected 30 minutes prior to all meals, and 15, 30, 60, 90, 120, 180 minutes post-meal, then and at midnight, 3 AM, and the next morning at 6:30 AM and 7:30 AM. A 24-hour weighted mean glucose (WMG) was determined by averaging multiple plasma glucose measurements over a 24-hour period.|Baseline and Week 4|Completers Population was used for all efficacy analyses, and required that a participant took at least one dose of study therapy, had a baseline measurement, and had a post-randomization measurement in the treatment period at Week 4.||mg/dL||95% Confidence Interval|Least Squares Mean
652580|NCT02004873|Secondary|Rate Response Operation of Micra|Assessment of whether the Micra sensor-indicated rate derived from the input of the accelerometer during the Minnesota Pacemaker Response Exercise Protocol (M-PREP) treadmill test conducted at the 3-month and 6-month follow-up visits was proportional to the workload. The sensor-indicated rate (in min^-1) and workload (in METS) were normalized for each subject relative to their minimum and maximum possible values so the normalized values have a minimum possible value of zero and a maximum possible value of 1. These normalized values were used in a random effect linear regression model to assess the relationship between the sensor-indicated rate and workload via estimation of the Kay-Wilkoff slope parameter. The tests at 3-month and 6-month visits were combined in one analysis.|3 Months and 6 Months Post Implant (combined analysis)|Subjects implanted with Micra who had usable M-PREP test(s) at 3-month and/or 6-month visits.||regression slope parameter|M-PREP tests|90% Confidence Interval|Mean
652582|NCT02004873|Primary|Pacing Capture Threshold|Subjects that have an adequate pacing capture threshold (PCT) at the 6-month post-implant visit, which is defined as PCT <=2 volts at 0.24 ms pulse width and the increase in PCT from implant to 6 months <=1.5 volts. The pacing capture threshold is the minimal electrical stimulus required to produce consistent cardiac depolarization. It is the minimum amount of energy that is required for a pacemaker to pace the heart.|6 Months Post Implant|Subjects implanted with Micra who had paired implant and 6-month auto decrement PCT values (at 0.24 ms), or who had a system modification or alternative device implant prior to 6 months due to elevated threshold.||participants|||Number
652583|NCT02004873|Primary|Major Complications|Micra system and/or procedure related major complication free rate at 6-months post-implant.|Implant to 6 Months Post Implant|All subjects who attempted Micra implant procedure||Kaplan-Meier survival probability (%)||98.66% Confidence Interval|Number
652584|NCT02004847|Other Pre-specified|Patient Acceptance of Hyperpigmentation|Questionaire|week 16|Safety set (SAF)||percentage of participants|||Number
652585|NCT02004847|Other Pre-specified|Thermal Comfort|Questionaire|week 12|Full Analysis Set||percentage of participants|||Number
652586|NCT02004847|Secondary|Adverse Device Events (Serious and Non-serious)|"Adverse device events: Adverse event related to the use of an investigational medical device wich led to any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons.
Serious adverse device event: Adverse device effect that has resulted in a) led to death, b) led to serious deterioration in the health of the subject, that either resulted in 1) a life-threatening illness or injury, or 2) a permanent impairment of a body structure or a body function, or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) led to foetal distress, foetal death or a congenital abnormality or birth defect."|week 0, 1, 2, 4, 8, 12, 16|Safety Set (SAF)||number of participants|||Number
652587|NCT02004847|Other Pre-specified|Adverse Events (Serious and Non-serious)||week 0, 1, 2, 4, 8, 12, 16|Safety Set (SAF)||number of participants|||Number
652588|NCT02004847|Other Pre-specified|"Hyperpigmentation of Normal Skin Areas Surrounding the Target Area Exposed to Blue Light and Control Area Not Exposed to Blue Light- Evaluation by Mexameter"|Arbitrary units measured by mexameter. Mexameter readings ranged from 0 to 100. Higher values correspond to higher pigmentation levels.|week 4, 12, 16|Safety Set (SAF)||arbitrary units||Standard Deviation|Mean
652589|NCT02004847|Secondary|Total Duration of Topical Co-treatment With Vitamin D of High Intensity (HI) and Low Intensity (LI)||week 16|Full Analysis Set (FAS); Not all patients requested co-use of vitamin D. Only 17 in HI group and 16 in LI group requested co-use of vitamin D||days||Standard Deviation|Mean
652590|NCT02004847|Secondary|Time to First Use of Topical Co-treatment With Vitamin D of High Intensity (HI) and Low Intensity (LI)||patients will be followed for the complete duration of the clinical study for 16 weeks|Full Analysis Set (FAS); Not all patients requested co-use of vitamin D. Only 17 in HI group and 16 in LI group requested co-use of vitamin D||days||Standard Deviation|Mean
652591|NCT02004847|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI)|It is a simple 10-question validated questionnaire. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. As the change from baseline is calculated negative values in the Outcome Measure Data indicate an improvement in quality of life.|baseline and week 12|Full Analysis Set (FAS)||units on a scale||Standard Deviation|Mean
652592|NCT02004847|Secondary|System Usability Scale|At the end of treatment (visit 7), the usability of the investigational device was evaluated by a questionnaire presented to the patient in German. The usability was evaluated by using the System Usability Scale (SUS) which is an effective tool for assessing the usability of a device. It provides an easy-to-understand score from 0 (negative) to 100 (positive).|week 12|Full Analysis Set (FAS); due to one drop out this number is 23 at week 12 for HI group. Only 17 of 22 patients completed the questionaire in the LI group.||units on a scale||Standard Deviation|Mean
652593|NCT02004847|Secondary|Change From Week 12 (End of Treatment) of Erythema Evaluated by Mexameter of the Target Area of High Intensity (HI) and Low Intensity (LI) as Compared to the Control Area at End of Follow-up|Erythema was measured directly after treatment. Mexameter readings ranged from 0 to 100. Higher values describe higher erythema levels.|week 12 and week 16|Full Analysis Set (FAS); due to one drop out in each group this number is 23 for HI Group and 22 for LI group at week 12 and 16||arbitrary units||Standard Deviation|Mean
652594|NCT02004847|Secondary|Change From Baseline of Erythema Evaluated by Mexameter of the Target Area of High Intensity (HI) and Low Intensity (LI) as Compared to the Control Area|Erythema was measured directly after treatment. Mexameter readings ranged from 0 to 100. Higher values describe higher erythema levels.|baseline and week 4, 12|Full Analysis Set (FAS)||arbitrary units||Standard Deviation|Mean
652595|NCT02004847|Secondary|Difference in Change From Baseline of Local Psoriasis Area Severity Index (PASI) Between Target and Control Area of the High Intensity (HI) Group as Compared to the Low Intensity (LI) Group|"In this study only the local PASI (also called local psoriasis severity index - LPSI) was evaluated. The investigator evaluated and graded the severity of erythema, induration, and scaliness as the key symptoms of psoriasis on the study areas using the following scale:
0. = no sign
= slight
= moderate
= marked
= very marked A total severity score was calculated as the sum of the three symptom ratings (range 0-12)."|baseline and week 4, 8, 16|Full Analysis Set (FAS)||units on a scale||Standard Deviation|Mean
652596|NCT02004847|Secondary|Change From Baseline (Visit 2) of the Local Psoriasis Area Severity Index (PASI) of the Target Area (Low Intensity (LI) Group) as Compared to the Control Area by Week.|"In this study only the “local” PASI (also called local psoriasis severity index – LPSI) was evaluated. The investigator evaluated and graded the severity of erythema, induration, and scaliness as the key symptoms of psoriasis on the study areas using the following scale:
0 = no sign, 1 = slight, 2 = moderate, 3 = marked,4 = very marked
A total severity score was calculated as the sum of the three symptom ratings (range 0-12 whereas 0 (best) - 12 (worst))."|baseline and week 4, 12, 16|Full Analysis Set (FAS)||units on a scale||Standard Deviation|Mean
652642|NCT02003638|Primary|Change From Baseline in Arterial Fluorodeoxyglucose (FDG) Uptake Assessed by FDG-PET/CT||12 weeks|||Target to Background Ratio (TBR)||Standard Deviation|Mean
655265|NCT01953328|Primary|Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
652597|NCT02004847|Secondary|Change From Week 12 of the Local Psoriasis Area Severity Index (PASI) of the Target Area (High Intensity) as Compared to the Control Area at End of Follow-up|"In this study only the “local” PASI (also called local psoriasis severity index – LPSI) was evaluated. The investigator evaluated and graded the severity of erythema, induration, and scaliness as the key symptoms of psoriasis on the study areas using the following scale:
0 = no sign, 1 = slight, 2 = moderate, 3 = marked,4 = very marked
A total severity score was calculated as the sum of the three symptom ratings (range 0-12 whereas 0 (best) - 12 (worst))."|Week 12 and week 16|Full Analysis Set (FAS); due to one drop out this number is 23 at week 12 and 16||units on a scale||Standard Deviation|Mean
652598|NCT02004847|Secondary|Change From Baseline of the Local Psoriasis Area Severity Index (PASI) of the Target Area (High Intensity) as Compared to the Control Area at End of Treatment During the Attack Period (Week 4, Visit 5)|"In this study only the “local” PASI (also called local psoriasis severity index – LPSI) was evaluated. The investigator evaluated and graded the severity of erythema, induration, and scaliness as the key symptoms of psoriasis on the study areas using the following scale:
0 = no sign, 1 = slight, 2 = moderate, 3 = marked,4 = very marked
A total severity score was calculated as the sum of the three symptom ratings (range 0-12 whereas 0 (best) - 12 (worst))."|baseline and week 4|Full Analysis Set||units on a scale||Standard Deviation|Mean
652599|NCT02004847|Primary|Change From Baseline (Visit 2) of the Local Psoriasis Area Severity Index (PASI) of the Target Area (High Intensity (HI) Group) as Compared to the Control Area at End of Treatment (Visit 7, Week 12).|"In this study only the “local” PASI (also called local psoriasis severity index – LPSI) was evaluated. The investigator evaluated and graded the severity of erythema, induration, and scaliness as the key symptoms of psoriasis on the study areas using the following scale:
0 = no sign, 1 = slight, 2 = moderate, 3 = marked,4 = very marked
A total severity score was calculated as the sum of the three symptom ratings (range 0-12 whereas 0 (best) - 12 (worst))."|baseline and week 12|Full Analysis set (FAS)||units on a scale||Standard Deviation|Mean
652659|NCT02002936|Secondary|Total Efficacy in Hematologic Improvement Ratio According to IWG 2006 Criteria.|NCA (not considered assessable): no evidence of HI-E (hematologic improvement-erythroid), HI-P (hematologic improvement-platelet), HI-N (hematologic improvement-neutorophil), progressive disease, or relapse.|Up to 3 years|||participants|||Number
652614|NCT02004158|Secondary|Objective Psychological Impact of Exercises|"Object psychological impact of exercises will be measured by clinician-administered questionnaires given at baseline and again at 8 weeks. These questionnaires include:
Life Orientation Test-Revised (scores range from 6-30; a high score means higher optimism)
Positive and Negative Affect Schedule (scores range from 10-50; a higher score means higher levels of affect)
Hospital Anxiety and Depression Scale (scores range from 0-42; a high score means higher depression and anxiety).
Objective psychological impact will be defined as having significantly improved scores at 8 weeks as compared to scores at baseline."|8 weeks|||points||Standard Deviation|Mean
652615|NCT02004158|Primary|Self-reported Psychological Impact of Exercises|Psychological impact of exercises will be measured by two self-reported 10-point Likert scales. One scale measures optimism after completing the exercise (0=not optimistic, 10=very optimistic), and the other scale measures happiness after completing the exercise (0=not happy, 10=very happy). Psychological impact will be defined as an average score of 6 or more on both of these scales.|8 weeks|||points||Standard Deviation|Mean
652616|NCT02004158|Primary|Ease of Exercises|Ease of exercises will be measured by a self-report 10-point Likert scale (0=not easy to complete, 10=very easy to complete). Ease will be defined as an average score of 6 or more on this scale.|8 weeks|||scores on a scale||Standard Deviation|Mean
652617|NCT02004158|Primary|Rate of Exercise Completion|Rate of exercise completion will be measured by the number of participants who have a good rate of completion of exercises. There are 8 exercises in total. A good rate of completion will be defined as an average of 5 or more exercises completed per subject.|8 weeks|||Participants|||Number
652618|NCT02004132|Secondary|Amount of Testosterone on Unworn Textiles Laundered With the Testosterone Exposed T-shirts|"This is a summary of the amounts of testosterone measured on unworn textile items washed with t-shirt halves exposed to testosterone in a standard washing machine. Total amounts of testosterone on each laundered item other than the t-shirt halves was calculated based on the weight of the fabric sample analyzed and the total weight of the item, assuming a uniform distribution of testosterone across each item as:
(weight of laundered item / weight of laundered sample) x amount of testosterone on laundered sample."|12 hours after application of study drug|FAS. Data from all enrolled participants completing the study.||µg||Standard Deviation|Mean
652619|NCT02004132|Secondary|Amount of Testosterone Following Laundering|This is a summary of the amounts of testosterone measured on a 10 cm × 10 cm of material excised from the underarm area of washed t-shirt halves following laundering in a standard washing machine.|12 hours after application of study drug|FAS. Data from all enrolled participants completing the study.||µg||Standard Deviation|Mean
652620|NCT02004132|Primary|Amount of Testosterone on T-shirts|This is a summary of the amounts of testosterone measured on a 10 centimeters (cm) × 10 cm of material excised from the underarm area of participant's unwashed t-shirt halves.|12 hours after application of study drug|Full analysis set (FAS). Data from all enrolled participants completing the study.||micrograms (µg)||Standard Deviation|Mean
652621|NCT02004093|Secondary|Kaplan-Meier Probability of Being Alive at 1 Year||1 year|All treated patients who received Randomized Treatment (All Treated Population, for Efficacy Analyses) were included in analysis.||percent|||Number
652622|NCT02004093|Secondary|Overall Survival|Survival was the interval of time from date of first dose of study medication to date of death at any time. Participants who had not died were censored at the date of last contact when they were known to be alive.|Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until 2 years after last dose of treatment|All treated participants were included in analysis||months||Full Range|Median
652623|NCT02004093|Secondary|Percentage of Participants Who Died||Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until 2 years after last dose of treatment|All treated participants were included in analysis||percentage of participants|||Number
652624|NCT02004093|Secondary|Time To Response|Time to response was the date of first dose of study medication to the date of the first documentation of response, according to CA 125 criteria for all participants or response according to RECIST criteria for participants with measurable disease. If response was evaluable by both criteria, then the date of response was for the earlier of the two events.|Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until 2 years after last dose of treatment|Only participants with a response were included in the analysis.||weeks||Inter-Quartile Range|Median
652625|NCT02004093|Primary|Kaplan-Meier Probability of No Disease or Progression at 1 Year|The probability of being event free (no disease progression or death events) at 1 year in participants remaining at risk.|1 year|All treated patients who received Randomized Treatment (All Treated Population, for Efficacy Analyses) were included in analysis. 17 and 12 participants in the chemotherapy + pertuzumab and chemotherapy treatment groups, respectively, remained at risk.||percent|||Number
652626|NCT02004093|Secondary|Kaplan-Meier Probability of Being Progression Free at 1 Year||1 year|All treated patients who received Randomized Treatment (All Treated Population, for Efficacy Analyses) were included in analysis. 16 and 10 participants in the chemotherapy + pertuzumab and chemotherapy treatment groups, respectively, remained at risk.||percent|||Number
652627|NCT02004093|Secondary|Time to Progressive Disease|The time to progressive disease is the interval of time from date of first dose of study medication to date of first documentation of progressive disease by either RECIST or CA 125 criteria. Participants who never progressed while being followed were censored at the last valid tumor measurement or CA 125 measurement.|Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression|All treated patients with an event (disease progression) were included in analysis||weeks||Inter-Quartile Range|Median
652628|NCT02004093|Secondary|Percentage of Participants With Disease Progression|Disease progression was assessed according to RECIST, for participants with measurable disease, or by changes in CA 125 according to GCIG for all participants. Participants who did not progress while being followed were censored at the time of the last valid tumor assessment or valid CA 125 assessment.|Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression|All treated participants were included in analysis||percentage of participants|||Number
652629|NCT02004093|Secondary|Kaplan-Meier Probability of Maintaining a Response to at Least 1 Year||1 year|All treated patients who received Randomized Treatment (All Treated Population, for Efficacy Analyses) were included in analysis. 7 and 5 participants in the chemotherapy + pertuzumab and chemotherapy treatment groups, respectively, remained at risk.||percent|||Number
652630|NCT02004093|Secondary|Duration of Response|For participants who achieved a response, the duration of response was defined as the interval between initial documentation of response to the first documentation of disease progression or death. Participants who responded and did not progress or die while on study or while being followed were censored at the last valid tumor or CA 125 measurement.|Day 15 of Cycles 2, 4, 6, and Day 15 of all Cycles from Cycle 7 to 17 until disease progression up to 104 weeks|Only participants with a response were included in the analysis; 8 participants and 13 participants were censored in the chemotherapy + pertuzumab and chemotherapy only treatment groups, respectively.||weeks||Inter-Quartile Range|Median
652631|NCT02004093|Secondary|Percentage of Participants With a Best Overall Confirmed Response Based on Combined CA 125 and RECIST Measurements|Response by tumor measurement occurred if there was documented and confirmed complete response (CR) or partial response (PR). For all participants, response was assessed by both the RECIST and by CA 125 levels, according to whether the participant had measurable or non-measurable disease at baseline. Response according to CA 125 levels was defined as at least a 50% reduction from baseline. The decrease had to be confirmed and maintained for at least 28 days. The confirmatory sample must have been less than or equal to the previous sample (within an assay variability of 10%). For overall response, the response categories were “response”, “stable disease” and “progressive disease”. Stable disease included 1) stable disease as defined by RECIST for solid tumors and 2) CA 125 levels that had not met the definition of “response” or “progressive disease”.|Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression up to 104 weeks|All treated patients who received Randomized Treatment (All Treated Population, for Efficacy Analyses) were included in analysis.||percentage of participants|||Number
652632|NCT02004093|Primary|Progression-Free Survival|Progression-free survival was defined as the time from first administration of study drug (Study Day 1) to documented disease progression or death, whichever occurred earlier. Disease progression was assessed according to RECIST, for participants with measurable disease, or by changes in CA 125 according to GCIG for all participants. Participants who did not progress or died while being followed were censored at the time of the last valid tumor assessment or valid CA 125 assessment.|Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression up to 104 weeks|All treated patients who received Randomized Treatment (All Treated Population, for Efficacy Analyses) were included in analysis.||weeks||Full Range|Median
652633|NCT02004093|Primary|Percentage of Participants With Disease Progression or Death|Disease progression was assessed according to RECIST (Response Evaluation Criteria In Solid Tumors), for participants with measurable disease, or by changes in CA 125 (Cancer Antigen 125) according to GCIG (Gynecologic Cancer Inter Group) for all participants. Participants who did not progress or died while being followed were censored at the time of the last valid tumor assessment or valid CA 125 assessment.|Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression up to 104 weeks|All treated participants who received Randomized Treatment (All Treated Population, for Efficacy Analyses) were included in analysis.||percentage of participants|||Number
652634|NCT02003963|Secondary|Change From Baseline in Self-efficacy Towards Exercise on the Self-Efficacy for Healthy Eating and Physical Activity Measure (SE-HEPA) at Week 13|SE-HEPA is a 13-item self-report survey with items based on a 5-point Likert scale. Possible scores range from 1 (Disagree a Lot) to 5 (Agree a Lot). The items are summed to a total score, and a higher score indicates a higher level of self-efficacy (range: 13 to 65). Results are reported as change scores from baseline.|Baseline clinic visit (Week 0) and final clinic visit (Week 13)|Four participants refused to complete the final assessment.||change scores on a scale||Standard Deviation|Mean
652635|NCT02003963|Secondary|Change From Baseline in Health-related Quality of Life|Self-report instrument to capture health-related quality of life (KIDSCREEN-10 Index)|Baseline clinic visit (week 0) and final clinic visit (week 13)||05/2017||||
652636|NCT02003963|Secondary|The Friendship Quality Questionnaire to Measure Change in Peer Support From Baseline to Week 13.|The Friendship Quality Questionnaire is a 21-item self-report survey in which the participant answers questions about his or her best friend related to companionship, conflict, help/aid, security, and closeness, on a 5-point Likert scale. The survey is internally consistent, with α ranging from 0.71 to 0.86, and adequate criterion validity across sub-scales.|Baseline clinic visit (week 0) and final clinic visit (week 13)||05/2017||||
652637|NCT02003963|Secondary|Change in Physical Activity|Actigraph accelerometer (7-day protocol using waking hours) and self-report instrument|Baseline clinic visit (week 0) and final clinic visit (week 13)|Data reported on participants with complete accelerometry data||change in self-reported days/week of PA||Full Range|Mean
652638|NCT02003963|Secondary|Feasibility|Attendance to exergaming intervention|3 gaming sessions/week for 12 weeks|"Attendance was only assessed for the Exergame Intervention participants"||percentage exergaming sessions attended||Full Range|Mean
652639|NCT02003963|Primary|Change in Resting Systolic Blood Pressure Percentile|Resting systolic blood pressure percentile|Baseline clinic visit (week 0) and final clinic visit (week 13)|||%ile||Standard Deviation|Mean
652640|NCT02003963|Primary|Change in Visceral Adiposity|Assessed by magnetic resonance imaging|Baseline clinic visit (week 0) and final clinic visit (week 13)|Intent to treat. Three participants did not complete baseline or final MRI scan due to exceeding weight limit or metal-containing object in the body, and five participants refused to complete final MRI scan.||kg||Standard Deviation|Mean
652641|NCT02003963|Primary|Change in Body Fat|Assessed by dual energy x-ray absorptiometry|Baseline clinic visit (week 0) and final clinic visit (week 13)|Intent to treat||kg||Standard Deviation|Mean
652645|NCT02003391|Secondary|Percentage Change From Baseline in IOP (8AM) at Week 4 in the Study Eye|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and is measured in mmHg. A more negative percent change from baseline indicates a greater amount of improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis.|Baseline (Day 0), Week 4|Intent to treat with a measurement in the study eye at Week 4||Percent Change||Standard Deviation|Mean
652646|NCT02003391|Secondary|Mean Change From Baseline in IOP (8AM) at Week 4 in the Study Eye|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and is measured in mmHg. A negative change indicates an improvement. One eye (study eye) contributed to the analysis.|Baseline (Day 0), Week 4|Intent to treat with a measurement in the study eye at Week 4||mmHg||Standard Deviation|Mean
652647|NCT02003391|Primary|Least Squares Mean Intraocular Pressure (IOP) at 8AM in the Study Eye|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and is measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye (study eye) contributed to the analysis.|Week 4|Intent to treat with a measurement in the study eye at Week 4||mmHg||95% Confidence Interval|Least Squares Mean
652648|NCT02003352|Primary|Change in Diagnostic and Statistical Manual of Mental Disorders IV Clinician-Administered PTSD Scale DSM IV-(CAPS)|The CAPS is the gold standard in PTSD assessment and is a 30-item structured interview.For each symptom, standardized questions and probes are provided. Administration requires identification of an index traumatic event to serve as the basis for symptom inquiry. The full interview takes 45-60 minutes to administer.CAPS symptom severity ratings are based on symptom frequency and intensity (except for amnesia and diminished interest which are based on amount and intensity). Higher scores represent a worse outcome with severity categories of 0-19 (minimal), 20-39 (mild), 40-59 (moderate), 60-79 (severe), 80-136 (extreme). We will use changes in the DSM-IV CAPS scores before and after treatment to distinguish between the estimated frequency and intensity of the various symptoms. Frequency and intensity scores will be combined to give a total CAPS score (range: 0–136) CAPS testing was scheduled pre-intervention, 1 week post-intervention, and at 3 months post-intervention.|up to 12 weeks|Changes in CAPS scores before-after. Frequency and intensity scores combined-CAPS score (range: 0–136) . CAPS pre-intervention, 1 week post-intervention, and at 3 months post-intervention. Difference pre and post of CAPS Scores (matched pairs) two-tailed t -Test with alpha of <0.05. Effect Size Cohen's D||units on a scale||95% Confidence Interval|Mean
652649|NCT02003014|Secondary|Change From Baseline Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)|The change between homeostasis model assessment of insulin resistance collected at 3 months, 6 months, 9 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. Homeostasis Model assessment of insulin resistance Measures insulin resistance, calculated by insulin times glucose, divided by a constant (22.5). A higher score indicates higher insulin resistance.|Baseline, Months 3, 6, 9, 12 and final assessment (up to Month 12)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.||HOMA-IR score||Standard Deviation|Mean
652650|NCT02003014|Secondary|Change From Baseline in Immunoreactive Insulin (IRI)|The change in the value of IRI (portion of insulin in blood measured by immunochemical methods for the hormone; presumed to represent the free [unbound] and biologically active fraction of total blood insulin) collected at 3 months, 6 months, 9 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline.|Baseline, Months 3, 6, 9, 12 and final assessment (up to Month 12)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.||micro units per milliliter (mcU/mL)||Standard Deviation|Mean
652651|NCT02003014|Secondary|Change From Baseline in Body Weight|Change relative to baseline in participant's weight measured at 3 months, 6 months, 9 months, 12 months or final visit (last visit for a participant in the study, up to Month 12).|Baseline, Months 3, 6, 9, 12 and final assessment (up to Month 12)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.||kg||Standard Deviation|Mean
652652|NCT02003014|Secondary|Change From Baseline in Fasting Blood Glucose|The change between the fasting blood glucose value collected at 3 months, 6 months, 9 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline.|Baseline, Months 3, 6, 9, 12 and final assessment (up to Month 12)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.||milligram per deciliter (mg/dL)||Standard Deviation|Mean
652653|NCT02003014|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at 3 months, 6 months, 9 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline.|Baseline, Months 3, 6, 9, 12 and final assessment (up to Month 12)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.||percentage of glycosylated hemoglobin||Standard Deviation|Mean
652654|NCT02003014|Primary|Number of Participants Reporting One or More Serious Adverse Drug Reactions|Serious adverse drug reactions are defined as serious adverse events (SAEs) which are in the investigator’s opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to 12 months|The safety analysis set was defined as all participants who were enrolled and completed the study.||participants|||Number
652655|NCT02003014|Primary|Number of Participants Reporting One or More Adverse Drug Reactions|Adverse drug reactions are defined as adverse events (AEs) which are in the investigator’s opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.|Baseline up to 12 months|The safety analysis set was defined as all participants who were enrolled and completed the study.||participants|||Number
652656|NCT02002936|Secondary|Changes in Clinical Laboratory Test Results|Clinically significant changes|Up to 3 years|||participants|||Number
652660|NCT02002936|Secondary|Total Efficacy in Hematologic Remission (IWG2006 Criteria)|"SD (stable disease): according to International Working Group 2006 response criteria for myelodysplastic syndrome, SD was defined as a failure to achieve complete remission or partial remission, but no evidence of progression for > 8 weeks."|Up to 3 years|||participants|||Number
652661|NCT02002936|Primary|Adverse Events|Total number affected by any adverse events (details are presented in adverse event section)|Up to 3 years|||participants|||Number
652662|NCT02002871|Other Pre-specified|Number of Participants With Acceptance of Hyperpigmentation at Week 6|"Questionaire if hyperpigmentation was acceptable if reported. Outcome was number of patients answering yes or no."|week 6|7 patients out of 20 patients reported hyperpigmentation at week 6.||participants|||Number
652663|NCT02002871|Other Pre-specified|Recovery of Hyperpigmentation During Follow up Period (Compared to Last Treatment)|Higher values describe a higher level of pigmentation.|week 6|||arbitrary units||Standard Deviation|Mean
652664|NCT02002871|Other Pre-specified|Device Deficiencies|This measure describes device deficiencies in general leading to a non functional device. No specific characteristics were assessed.|over 6 weeks|||participants|||Number
652665|NCT02002871|Other Pre-specified|Adverse Device Events (Serious and Non-serious)||over 6 weeks|||participants|||Number
652666|NCT02002871|Other Pre-specified|Adverse Events (Serious and Non-serious)||week 0, 2, 4, 6|||participants|||Number
652667|NCT02002871|Other Pre-specified|Hyperpigmentation – Evaluation by Mexameter|Higher values describe a higher level of pigmentation.|week 0, 2, 4, 6|||arbitrary units||Standard Deviation|Mean
652668|NCT02002871|Secondary|Change From Week 4 (End of Treatment) of Patient Rating of Itching of the Target Area as Compared to the Control Area at End of Follow-up|patients were asked to rate itching on a VAS scale (1 no itching; 100 worst imaginable itching).|week 6|||units on a scale||Standard Deviation|Mean
652669|NCT02002871|Secondary|Change From Baseline of Patient Rating of Itching of the Target Area as Compared to the Control Area|patients were asked to rate itching on a VAS scale (1 no itching; 100 worst imaginable itching)|week 4, 6|||units on a scale||Standard Deviation|Mean
652670|NCT02002871|Secondary|Change From Week 4 (End of Treatment) of Inflammation (Erythema) Evaluated by Mexameter of the Target Area as Compared to the Control Area at End of Follow-up|Higher values describe a higher level of erythema.|week 6|||arbitrary units||Standard Deviation|Mean
652671|NCT02002871|Secondary|Change From Baseline of Inflammation (Erythema) Evaluated by Mexameter of the Target Area as Compared to the Control Area|Higher values describe higher erythema levels.|week 4, 6|||arbitrary units||Standard Deviation|Mean
652672|NCT02002871|Secondary|Change From Week 4 of the Sum Score of Local Eczema Rating as Compared to the Control Area at End of Follow-up|The investigator rated the key symptoms erythema, induration/papulation/edema, excoriation, lichenification and crusts on a score of 0-3 (none, mild, moderate, and severe) with half steps allowed. A total severity score was calculated as the sum of the single symptom ratings (range 0-15 whereas 0 (best) - 15 (worst)).|week 6|||units on a scale||Standard Deviation|Mean
652673|NCT02002871|Primary|Change From Baseline (Visit 2) of the Sum Score of Local Eczema Rating of the Target Area as Compared to the Control Area at End of Treatment|The investigator rated the key symptoms erythema, induration/papulation/edema, excoriation, lichenification and crusts on a score of 0-3 (none, mild, moderate, and severe) with half steps allowed. A total severity score was calculated as the sum of the single symptom ratings (range 0-15 whereas 0 (best) - 15 (worst)).|at week 4|Overall number of participants is also 20 because control and treated plaque were anaylsed on the same patient.||units on a scale||Standard Deviation|Mean
652674|NCT02002702|Secondary|Change From Baseline in Neutrophil Gelatinase-asc Lipocalin (NGAL) Levels Through Day 14|Neutrophil gelatinase-asc lipocalin (NGAL) biomarker was used to assess the effect of serelaxin on kidney function. Geometric means of the ratio of post-Baseline values to baseline values of NGAL was calculated by treatment for the full analysis set.|Baseline, Day 1, Day 2, Day 5, Day 14|The analysis was performed in the FAS population. Only participants with a value at both baseline and the post-dose time point were included.||Ratio||95% Confidence Interval|Geometric Mean
652675|NCT02002702|Secondary|Change From Baseline in NT-proBNP Levels Through Day 14|NT-proBNP biomarker was used to assess the effect of serelaxinin on degree of cardiac wall stress and congestion. Geometric means of the ratio of post-Baseline values to baseline values of NT-proBNP was calculated by treatment for the full analysis set.|Baseline, Day 1, Day 2, Day 5, Day 14|The analysis was performed in the FAS population. Only participants with a value at both baseline and the post-dose time point were included.||Ratio||95% Confidence Interval|Geometric Mean
652676|NCT02002702|Secondary|Change From Baseline in High Sensitivity Troponin-T Levels Through Day 14|High sensitivity Troponin-T biomarker was used to assess the effect of serelaxin on myocardial damage. Geometric means of the ratio of post-Baseline values to baseline values of high sensitivity troponin-t was calculated by treatment for the full analysis set.|Baseline, Day 1, Day 2, Day 5, Day 14|The analysis was performed in the FAS population. Only participants with a value at both baseline and the post-dose time point were included.||Ratio||95% Confidence Interval|Geometric Mean
652677|NCT02002702|Secondary|Change From Baseline in Cystatin-C Levels Through Day 14|Cystatin-C biomarker was used to assess the effect of serelaxinin on worsening of renal function. Geometric means of the ratio of post-Baseline values to baseline values of Cystatin-C was calculated by treatment for the full analysis set.|Baseline, Day 1, Day 2, Day 5, Day 14|The analysis was performed in the FAS population. Only participants with a value at both baseline and the post-dose time point were included.||Ratio||95% Confidence Interval|Geometric Mean
652678|NCT02002702|Secondary|Change From Baseline in Aldosterone Levels Through Day 14|Aldosterone biomarker was used to assess the effect of serelaxinin on fluid retention. Geometric means of the ratio of post-Baseline values to baseline values of aldosterone was calculated by treatment for the full analysis set.|Baseline, Day 1, Day 2, Day 5, Day 14|The analysis was performed in the FAS population. Only participants with a value at both baseline and the post-dose time point were included.||Ratio||95% Confidence Interval|Geometric Mean
652736|NCT02000427|Secondary|Percentage of Participants Who Received an Allogeneic Hematopoietic Stem Cell Transplant (HSCT) During Blinatumomab Induced Remission|Participants who achieved remission (CR/CRh*) during the first 2 cycles of treatment and received an allogeneic HSCT.|Up to the data cut-of date of 20 May 2015; Maximum duration on study was 14.5 months.|Participants who received an infusion of blinatumomab and had a CR/CRh* response during the first 2 cycles of treatment.||percentage of participants||95% Confidence Interval|Number
652679|NCT02002702|Secondary|Change From Baseline in Area Under the Curve (AUC) for Systolic Blood Pressure (SBP) Through 48 Hours of Infusion at Day 5|"The area under the curve (AUC) was defined as area under the plasma concentration-time curve from time zero to time of the last time point with measurable concentration, calculated by a trapezoidal method. Systolic blood pressure was measured using a calibrated standard sphygmomanometer after the subject remained in sitting position for 3 minutes at clinic during the visit. Sample collected at: Baseline; 30 & 60 minutes and then every hour for the first 6 hours of study drug infusion, and then every 3 hours during 48 hours of study drug infusion; every 3 hours until 12 hours following end of infusion, then every 6 hours for 48 hours and then every 24 hours until the earlier of Day 5 or discharge.
AUC for SBP is standardized by dividing by the length of respective time ranges."|Baseline, 48 hours, Day 5|The analysis was performed in the full analysis set (FAS) population, defined as all participants who were randomized in the study.||mmHg||Standard Error|Least Squares Mean
652680|NCT02002702|Primary|Concentration at Steady-state (Css) of Serelaxin|Concentration at steady-state (Css) was defined as concentration at the state of equilibrium obtained at the end of a certain number of administrations. Css of serelaxin in plasma was calculated by using a non-compartmental model approach.|Baseline (pre-dose), 1, 2, 24, 48, 49, 52 and 56 hours (post-dose)|"The analysis was performed in the PK population. Here, Number of participants analyzed signifies participants evaluable for this PK parameter at the specified time points for each arm, respectively."||ng/mL||Standard Deviation|Mean
652681|NCT02002702|Primary|Weight Adjusted Clearance (CL) of Serelaxin|Weight adjusted clearance (CL) was defined as the total body clearance of serelaxin after drug administration. CL was calculated as nominal infusion rate divided by Css, using a non-compartmental model approach.|Baseline (pre-dose), 1, 2, 24, 48, 49, 52 and 56 hours (post-dose)|"The analysis was performed in the PK population. Here, Number of participants analyzed signifies participants evaluable for this PK parameter at the specified time points for each arm, respectively."||mL/hr/kg||Standard Deviation|Mean
652682|NCT02002702|Primary|Maximum Plasma Concentration (Cmax) of Serelaxin|Maximum plasma concentration (Cmax) was defined as the peak level of serelaxin, derived from plasma concentration-time data, using a non-compartmental model approach.|Baseline (pre-dose), 1, 2, 24, 48, 49, 52 and 56 hours (post-dose)|"The analysis was performed in the pharmacokinetic (PK) set, defined as all participants who received study treatment and had at least one evaluable PK parameter data. Here, Number of participants analyzed signifies participants evaluable for this PK parameter at the specified time points for each arm, respectively."||nanogram(s)/milliliter (ng/mL)||Standard Deviation|Mean
652683|NCT02002702|Primary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs and SAEs, AEs Requiring Dose Adjustment or Interruption and Additional Therapy|AEs were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. SAEs were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards. AEs leading to discontinuations, or requiring dose adjustment or interruptions and additional therapy were assessed.|From start of study treatment up to Day 5 (for AEs); From start of study treatment up to Day 14 (for SAEs)|The analysis was performed on the safety population, defined as all participants who received at least one dose of study treatment and had at least one post-baseline assessment.||participants|||Number
652684|NCT02002689|Secondary|Kaplan-Meier Estimates of Progression Free Survival (PFS )Timing, Months||4 months|||months||95% Confidence Interval|Median
652685|NCT02002689|Secondary|Summary of Timing and Estimated Rate for Progression-free Survival (PFS) – Full Analysis Set|Progression-free survival (PFS) is the time from the date of start of treatment to the date of event defined as the first documented progression or death due to any cause within 30 days of last dose. If a subject has not had an event, progression-free survival is censored at the date of last adequate tumor assessment.|4 months|Full Analysis set||% progression free surviors||95% Confidence Interval|Number
652686|NCT02002689|Primary|Summary of Overall Response (ORR) and Clinical Benefit (CBR)|Clinical benefit rate (CBR) Number and percentage of subjects with CBR (responses of CR, PR or SD ≥ 16 weeks) as assessed by investigator was reported for all patients along with 95% exact confidence interval (CI). Overall Response Rate (ORR) Overall response was to be determined by investigator assessment for each tumor in the study. For subjects with solid tumors, the assessment criteria was RECIST 1.1 and included responses of CR and/or PR. The number and percentage of subjects for different categories of overall response (e.g., for solid tumors – CR, PR, SD, PD, Not Evaluable) were to be provided for solid tumors, and each hematological tumor type (if applicable). Ninety-five percent (95%) exact CI was to be provided for the response rate(s) (e.g., for solid tumors – CRn and/or PR) as well.|16 weeks|Full analysis set||percent responders|||Number
652687|NCT02002650|Secondary|Moderate-to-severe Pancreatitis|Moderate pancreatitis requiring hospitalization of 4-10 days. Severe pancreatitis requiring hospitalization for more than 10 days, or hemorrhagic pancreatitis, phlegmon or pseudocyst, or intervention (percutaneous drainage or surgery).|30 days|||participants|||Number
652688|NCT02002650|Primary|Post-ERCP Pancreatitis|Subjects were diagnosed with post-ERCP pancreatitis if they experienced new upper abdominal pain, serum amylase elevation at least three times the upper limit of normal 24 hours after the procedure, and hospitalization prolonged at least two nights.|30 days|||participants|||Number
652689|NCT02002221|Secondary|Number of Participants With Adverse Events, Serious Adverse Events and Death|The occurrence of adverse events was sought by non-directive questioning of the patient at each visit. Adverse events are defined as appearance or worsening of any undesirable symptom, vital sign, or medical conditions. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.|12 weeks|The safety set consisted of all patients who received at least one dose of study medication.||Participants|||Number
652810|NCT01998880|Secondary|Overall Survival|Overall Survival (OS) was defined as the time between the date of randomization and the date of death due to any cause.|Randomization to clinical cutoff (median observation 15.2 months)|Intent-to-treat population included all randomized participants. Patients without OS events were censored.||Months||95% Confidence Interval|Median
652690|NCT02002221|Secondary|Number of Participants With Incidence of Hypoglycemia and Severe Hypoglycemia|Hypoglycemic events are defined as a) symptoms suggestive of hypoglycemia, where the patient is able to initiate self-treatment and plasma glucose measurement is < 56 mg/dL (grade 1), b) symptoms suggestive of hypoglycemia, where the patient is unable to initiate self-treatment and plasma glucose measurement is < 56 mg/dL (grade 2), c) symptoms suggestive of hypoglycemia, where the patient is unable to initiate self-treatment and no plasma glucose measurement is available (suspected grade 2)|12 weeks|The safety set consisted of all patients who received at least one dose of study medication.||Participants|||Number
652691|NCT02002221|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at 12 Weeks|FPG was performed on a blood sample obtained and analyzed at a central laboratory.|Baseline, week 12|The full analysis set consisted of all randomized patients who received at least one dose of study medication and had at least one post-baseline assessment of efficacy parameter measurement. Number of patients with observations at both baseline and endpoint are analyzed in this endpoint.||mg/dL||Standard Error|Least Squares Mean
652692|NCT02002221|Secondary|Percentage of Patients Meeting Responder Rates in HbA1c|Responder rate was analyzed in categories: Criterion 1- Endpoint HbA1c ≤ 6.5%, Criterion 2- Endpoint HbA1c < 7% , Criterion 3- Endpoint HbA1c < 7% in patients with baseline HbA1c ≤ 8%, Criterion 4- HbA1c reduction from baseline at endpoint ≥ 1%, Criterion 5- HbA1c reduction from baseline at endpoint ≥ 0.5%. The number of patients analyzed for Criterion 1 and 2 include only patients with baseline HbA1c ≥ 7% (> 6.5%) and endpoint HbA1c measurement. The number of patients analyzed for Criterion 3 includes only patients with 7% ≤ baseline HbA1c ≤ 8% and endpoint HbA1c measurement. The number of patients analyzed for Criterion 4 and 5 include patients with both baseline and endpoint HbA1c measurements.|Baseline, week 12|The full analysis set consisted of all randomized patients who received at least one dose of study medication and had at least one post-baseline assessment of efficacy parameter measurement.||percentage of patients|||Number
652693|NCT02002221|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 12 Weeks Between Treatment Groups|HbA1c was performed on a blood sample obtained and measured by high performance liquid chromatography performed at a central laboratory.|Baseline, week 12|The full analysis set consisted of all randomized patients who received at least one dose of study medication and had at least one post-baseline assessment of efficacy parameter measurement.||percentage of glycosylated haemoglobin||Standard Error|Least Squares Mean
652694|NCT02002208|Secondary|Rate of Flares||over 16 weeks|||flares||Standard Deviation|Mean
652695|NCT02002208|Primary|Change From Baseline in Eczema Area and Severity Index (EASI) Compared to Placebo at Week 16|The EASI scoring system uses a defined process to grade the severity of the signs of eczema and the extent affected in four regions of the body: head and neck, trunk, upper extremities and lower extremities. The scale ranges from 0 to 72 and the severity strata for the EASI are as follows: 0 clear; 0.1–1.0 almost clear; 1.1–7.0 mild; 7.1–21.0 =moderate; 21.1–50.0 severe; 50.1–72.0 very severe. When assessing response to therapy a reduction of 7 or more is considered to be clinically meaningful.|EASI was measured at baseline (week 0) and 16 weeks after dosing.|Adjusted mean change from baseline EASI at Week 16||units on a scale||Standard Error|Mean
652696|NCT02001181|Secondary|Change From Baseline in the EASI Clinical Signs Severity Sum Score at Week 4|The EASI Clinical Signs Severity Sum Score was derived from the EASI. The Clinical Signs Severity Scores on the 4-point scale for dermatitis lesions were summed in each EASI body region. The sum of the Clinical Signs Severity Score in each EASI body region was then totaled across the 4 EASI body regions to provide an EASI Clinical Signs Severity Sum Score, which ranged from 0 to 48, with higher scores representing greater severity of atopic dermatitis.|Baseline (pre-dose on Day 1) and Week 4|The FAS included all participants who were randomized and received at least 1 dose of study drug. Missing data was not imputed. N=number of participants who were in FAS and had a baseline value and an observation at Week 4.||units on a scale||Standard Deviation|Mean
652697|NCT02001181|Secondary|Percent Change From Baseline in Body Surface Area (BSA) Efficacy at Week 4|The percent BSA with atopic dermatitis in a body region was determined by the number of handprints of atopic dermatitis skin in that region: head and neck, upper limbs, trunk including axillae, lower limbs including buttocks. In the handprint method, the full palmar hand of the participant (i.e., the participant's fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. What is reported is the percent change from baseline in BSA affected.|Baseline (pre-dose on Day 1) and Week 4|The FAS included all participants who were randomized and received at least 1 dose of study drug. Missing data was not imputed. N=number of participants who were in FAS and had a baseline value and an observation at Week 4.||percent change||Standard Deviation|Mean
652698|NCT02001181|Secondary|Proportion of Participants With Response of Clear or Almost Clear and Greater Than or Equal to (>=) 2 Grade/Point Improvement From Baseline at Week 4|The PGA score assesses the overall severity of atopic dermatitis. Scores range from 0 to 4 and correspond to a category (clear, almost clear, mild, moderate, and severe, respectively) based on morphological descriptors.|Baseline (pre-dose on Day 1) and Week 4|The FAS included all participants who were randomized and received at least 1 dose of study drug. Participants who were in FAS and had a baseline PGA score of 2 or 3 were included in the analysis. Participants with missing data at Week 4 were considered non-responders.||percentage of participants|||Number
652699|NCT02001181|Secondary|Proportion of Participants Achieving Physician's Global Assessment (PGA) Response of Clear or Almost Clear at Week 4|The PGA score assesses the overall severity of atopic dermatitis. Scores range from 0 to 4 and correspond to a category (clear, almost clear, mild, moderate, and severe, respectively) based on morphological descriptors.|Week 4|The FAS included all participants who were randomized and received at least 1 dose of study drug. Participants who were in FAS and had a baseline PGA score of 2 or 3 were included in the analysis. Participants with missing data at Week 4 were considered non-responders.||percentage of participants|||Number
652737|NCT02000427|Secondary|Overall Survival|"Overall survival was assessed from the date the participant received the first infusion of blinatumomab until death from any cause or the date of the last follow-up.
Participants still alive at the data cut-off date were censored on the last documented visit date or the date of the last contact when the patient was last known to have been alive."|From first dose of blinatumomab until the data cut-off date; median observation time was 8.8 months.|All participants who received an infusion of blinatumomab||months||95% Confidence Interval|Median
655266|NCT01953328|Primary|Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
652700|NCT02001181|Primary|Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 4|The EASI quantifies the severity of a participant’s atopic dermatitis based on both lesion severity and the percent of BSA affected. The EASI is a composite scoring by the atopic dermatitis clinical evaluator of the degree of erythema, induration/papulation, excoriation, and lichenification (each scored separately) for each of 4 body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of atopic dermatitis. What is reported is the percent change from baseline in EASI scores.|Baseline (pre-dose on Day 1) and Week 4|The full analysis set (FAS) included all participants who were randomized and received at least 1 dose of study drug. Missing data was not imputed. N=number of participants who were in FAS and had a baseline value and an observation at Week 4.||percent change||Standard Error|Least Squares Mean
652701|NCT02000973|Secondary|Bispectral Index Score|The bispectral index(BIS) score of each patient was recorded at two different time points. BIS values varies from 0 to 100(0, no cerebral activity; 40 to 60, general anesthesia; 60 to 85, sedated; 85 to 100, awake).|Before starting anesthesia to finishing endotracheal intubation|||units on a scale||Standard Deviation|Mean
652702|NCT02000973|Secondary|Heart Rate|The heart rate of each patient was recorded at five different time points|Before starting anesthesia to finishing endotracheal intubation|||beats per minute||Standard Deviation|Mean
652703|NCT02000973|Secondary|Mean Arterial Pressure|The mean arterial pressure of each patient was recorded at five different time points|Before starting anesthesia to finishing endotracheal intubation|||mmHg||Standard Deviation|Mean
652704|NCT02000973|Primary|Propofol Effect-site Concentration|The effect-site concentration of propofol when loss of consciousness during propofol target-controlled infusing(TCI) induction of anesthesia.|Before starting anesthesia to finishing endotracheal intubation|||ug/ml||Standard Deviation|Mean
652705|NCT02000921|Secondary|Carcinogen Exposure Biomarker: Total NNAL|Total NNAL (pmol/mg creatinine) is a measure of carcinogen exposure assessed at the end of intervention.|Week 8 (end of intervention)|||pmol//mg creatinine||95% Confidence Interval|Mean
652706|NCT02000921|Secondary|Rate of 24 Hour Quit Attempts|Rate of 24 hour quit attempts during the intervention period|8 week intervention period|||Participants|||Count of Participants
652707|NCT02000921|Primary|Number of Combusted Products Smoked|Number of combusted products smoked per day during the last two weeks of the intervention period.|At weeks 6-8 (last two weeks of intervention period)|||combuster products per day||Standard Deviation|Mean
652708|NCT02000921|Primary|Number of Days Using Alternative Products|The primary aim of the study is to determine the rate of use of alternative nicotine-containing products across the three experimental conditions.|8 week intervetnion period|||Number of days||Standard Deviation|Mean
652709|NCT02000752|Secondary|Degree of Ease With Which the Acupuncturist Administered the Treatment|"The degree of ease with which the acupuncturist administered the treatment was measured in a survey that the midwife carries out no more than 2 hours after the labor. The value was recorded using a numerical scale ranging between 0-100, with 4 levels: 100 - high ease, 75 - moderate ease, 50 - medium ease and 25 - low ease"|Measured into the 2 hours after the childbirth but before puerperal woman is moved to the obstetrics plant out of the labor room|||units on a scale||Standard Deviation|Mean
652710|NCT02000752|Secondary|Percentage of Mothers That Would Recommend the Technique to Any of Her Friends|"The number of mothers that would recommend the technique to any of her friends is analyzed in the survey that the midwife carries out no more than 2 hours after the labor. The possible responses are I would recommend it, or I would not recommend it."|Measured into the 2 hours after the childbirth but before puerperal woman is moved to the obstetrics plant out of the labor room|||percentage|||Number
652711|NCT02000752|Secondary|Percentage of Participants Who Reported Experiencing Pain Related to Treatment|The existence of pain related to the treatment is analyzed by the survey that the midwife carries out no more than 2 hours after the labor. A scale with 4 levels was used (no pain, mild pain, moderate pain, great pain).|Measured into the 2 hours after the childbirth but before puerperal woman is moved to the obstetrics plant out of the labor room|||percentage|||Number
652712|NCT02000752|Primary|The Principal Outcome of the Study is the Placental Expulsion Time.|This time is measured by the midwife who is responsible of the birth, and it considers the time passed between the delivery of the newborn and the complete expulsion of the placenta.|Up to 30 minutes after the newborn delivery|||minutes||95% Confidence Interval|Mean
652713|NCT02000531|Secondary|Participants With Adverse Events||start of second-line treatment to data cut-off in December 2014 (within 12 months)|Safety Population, defined as all participants enrolled in this extension study||participants|||Number
652714|NCT02000531|Primary|Progression Free Survival (PFS) Based on Well-documented and Verifiable Progression Events|Progression free survival is defined as the time of randomization in ENSURE study to progressive disease (PD) while on second-line treatment or death from any cause, whichever occurred first during the second-line treatment.|within 3 years, 9 months (data cut-off December 2014)|Intention to treat population, defined as all participants enrolled in this extension study||Months||95% Confidence Interval|Median
652715|NCT02000440|Secondary|Plasma Losmapimod 7.5 mg Maximum Observed Concentration (Cmax)|PK of losmapimod 7.5 mg was evaluated in participants with FSGS using Cmax PK samples were collected at Week 0 (pre-dose and 1, 2, 4, 6 hrs post-dose). Plasma concentration-time data were collected only up to 6 hours post the first 7.5 mg dose and only up to 2 hours post the first 15 mg dose and were not adequate to conduct a noncompartmental analysis to compare with historical data.|Week 0 (Pre-dose and 1, 2, 4, 6 hrs post-dose)|PK Population.|||||
652716|NCT02000440|Secondary|(AUC[0-tau]) of Losmapimod 15 mg in Plasma|PK of losmapimod 15 mg was evaluated in participants with FSGS using AUC over the dosing interval of losmapimod 15 mg. PK samples were collected at Week 2 (Pre-dose, 2 hrs post-dose) and Week 4, 8, 16, 24 (one of the following post-dose times: 0-2 hrs, 2-4 hrs, 4-6 hrs, and 6-8 hrs post-dose). Plasma concentration-time data were collected only up to 6 hours post the first 7.5 mg dose and only up to 2 hours post the first 15 mg dose and were not adequate to conduct a noncompartmental analysis to compare with historical data.|Week 2 (Pre-dose, 2 hrs post-dose) and Week 4, 8, 16, 24 (at one of the following post-dose times: 0-2 hrs, 2-4 hrs, 4-6 hrs, and 6-8 hrs post-dose)|PK Population.|||||
655267|NCT01953237|Primary|Adherence to Antipsychotic Medications||3 month period|||percentage of days adherent||Standard Deviation|Mean
652717|NCT02000440|Secondary|Area Under Concentration-time Curve (AUC) From Time Zero to Time t (AUC[0-t]) and AUC From Time Zero to the End of Dosing Period (AUC[0-tau]) of Losmapimod 7.5 mg in Plasma|Pharmacokinetics (PK) of losmapimod 7.5 mg was evaluated in participants with focal segmental glomerulosclerosis (FSGS) using AUC over the dosing interval of losmapimod 7.5 mg. PK samples were collected at Week 0 (pre-dose and 1, 2, 4, 6 hrs post-dose). Plasma concentration-time data were collected only up to 6 hours post the first 7.5 mg dose and only up to 2 hours post the first 15 mg dose and were not adequate to conduct a noncompartmental analysis to compare with historical data.|Week 0 (Pre-dose and 1, 2, 4, 6 hrs post-dose)|PK Population: All participants from whom a PK sample obtained and analyzed, included in the PK population.|||||
652718|NCT02000440|Secondary|Percent Change From Baseline in Cystatin C at Indicated Time Points|Cystatin C was assessed at Baseline (Week 0), at Weeks 2, 4, 8, 16, 24 and Follow-up (Week 30 and 36) phase. Baseline was defined as the value obtained at Week 0. Change from Baseline was calculated as visit value minus value at Baseline.|Baseline (Week 0), Week 2, Week 4, Week 8, Week 16, Week 24, End of study, and until the follow-up visit (Week 30 and Week 36)|All Subject Population||Percent change||Standard Deviation|Mean
652719|NCT02000440|Secondary|Change From Baseline in Glomerular Filtration Rate (GFR) at Indicated Time Points|eGFR was calculated by using the 4-variable Modification of Diet in Renal Disease (MDRD) at Baseline (Week 0), at Weeks 2, 4, 8, 16, 24 and Follow-up (Week 30 and 36) phase. Baseline was defined as the value obtained at Week 0. Change from Baseline was calculated as visit value minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline (Week 0), Week 2, Week 4, Week 8, Week 16, Week 24, End of study, and until the follow-up visit (Week 30 and Week 36)|All Subject Population.||milliliter/minute/1.73 square meters||Standard Deviation|Mean
652720|NCT02000440|Secondary|Change From Baseline in Serum Creatinine at Indicated Time Points|Serum creatinine were assessed at Baseline (Week 0), at Weeks 2, 4, 8, 16, 24 and Follow-up (Week 30 and 36) phase. Baseline was defined as the value obtained at Week 0. Change from Baseline was calculated as visit value minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline (Week 0), Week 2, Week 4, Week 8, Week 16, Week 24, End of study, and until the follow-up visit (Week 30 and Week 36)|All Subject Population||Milligram per deciliter (mg/dl)||Standard Deviation|Mean
652721|NCT02000440|Secondary|Change From Baseline in Liver Function Parameters: Albumin and Total Protein at Indicated Time Points|Clinical chemistry parameters: albumin and total protein were assessed at Baseline (Week 0), at Weeks 2, 4, 8, 16, 24 and Follow up (Week 30 and 36) phase. Baseline was defined as the value obtained at Week 0. Change from Baseline was calculated as visit value minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline (Week 0), Week 2, Week 4, Week 8, Week 16, Week 24, End of study, and until the follow-up visit (Week 30 and Week 36)|All Subject Population||Grams per liter (g/L)||Standard Deviation|Mean
652722|NCT02000440|Secondary|Change From Baseline in Liver Function Parameters: Direct Bilirubin and Total Bilirubin at Indicated Time Points|Clinical chemistry parameters: direct bilirubin and total bilirubin were assessed at Baseline (Week 0) and at Weeks 2, 4, 8, 16 24, End of studyand Follow-up (Week 30 and 36) phase. Baseline was defined as the value obtained at Week 0. Change from Baseline was calculated as visit value minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline (Week 0), Week 2, Week 4, Week 8, Week 16, Week 24, End of study, and until the follow-up visit (Week 30 and Week 36)|All Subject Population||Micromoles per liter (umol/L)||Standard Deviation|Mean
652723|NCT02000440|Secondary|Change From Baseline in Liver Function Parameters: Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) at Indicated Time Points|Blood samples were collected at Screening (Week -4 and -2), Baseline (Week 0) and at Weeks 2, 4, 8, 16, 24 and Follow-up (Week 30 and 36) to evaluate ALT, AST, AP and GGT. Baseline was defined as the value obtained at Week 0. Change from Baseline was calculated as visit value minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline (Week 0), Week 2, Week 4, Week 8, Week 16, Week 24, End of study, and until the follow-up visit (Week 30 and Week 36)|All Subject Population||International Units/liter (IU/L)||Standard Deviation|Mean
652724|NCT02000440|Secondary|Change From Baseline in Heart Rate at Indicated Time Points|Heart rate was measured at screening, Baseline and throughout the treatment phase (Week 24) and Follow-up phase (Week 36). Heart rate measurement was repeated if the values are calculated <50 beats per minute. (bpm) or >110 bpm after the start of dosing. Baseline was defined as the value obtained at Week 0. Change from Baseline was calculated as visit value minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline (Week 0), Week 2, Week 4, Week 8, Week 16, Week 24, End of study, and until the follow-up visit (Week 30 and Week 36)|All Subject Population||bpm||Standard Deviation|Mean
652725|NCT02000440|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Blood pressure was measured in a sitting position after 5 minutes rest with comfortably seated, legs uncrossed and the back and arm supported, such that the middle of the cuff on the upper arm is at the level of the right atrium and asked to remove all clothing that covered the location of cuff placement. It was recorded at Screening, Baseline, Week 2, Week 4, Week 8, Week 16, Week 24, End of study, and until the follow-up visit (Week 30 and Week 36). Vital sign measurements were repeated if the values were < 80 mmHg or > 140 mmHg SBP and <40 mmHg or >90 mmHg for DBP. Baseline was defined as the value obtained on Week 0. Change from Baseline was calculated as visit value minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline (Week 0), Week 2, Week 4, Week 8, Week 16, Week 24, End of study, and until the follow-up visit (Week 30 and Week 36)|All Subject Population||Millimeter of mercury (mmHg)||Standard Deviation|Mean
652726|NCT02000440|Secondary|Number of Participants Withdrawn Due to Toxicities|Participants were monitored from start of the study treatment (Week 0) up to Week 36 for development of toxicity. Participants who developed toxicity during the period were to be withdrawn from the study.|From start of the study treatment (Week 0) until the Follow-up phase (Week 36)|All Subject Population||Participants|||Number
653516|NCT01982435|Secondary|Participants With BCVA at 20/40 or Better|Number of participants with 20/40 or better best-corrected visual acuity in their study eye at months 6 and 12.|Months 6 and 12|||Participants|||Count of Participants
652727|NCT02000440|Secondary|Number of Participants Having Any Adverse Events (AEs), Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinaemia were categorized as SAE. Participants having any AE or SAE were included in the analysis.|From start of the study treatment (Week 0) until the Follow-up phase (Week 36)|All Subject Population||Participants|||Number
652728|NCT02000440|Secondary|Number of Participants With Complete Proteinuria Remissions at the Indicated Time Points|Incidence of complete remissions at any time point was defined as 24 hour total protein <0.3 gram (g) per Day and maintenance of >=70 percent of Baseline eGFR throughout the treatment period. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Week 2, Week 4, Week 8, Week 16 and Week 24|Completed Treatment Population||Participants|||Number
652729|NCT02000440|Secondary|Percent Change From Baseline in Urinary Protein/Creatinine (Up/c) Ratio (Spot and 24 Hours [hr])|Reduction in proteinuria was measured by the Up/c ratio (spot and 24 hr) at Baseline, Week 2, 4, 8, 16, 24, end of study and at Follow-up (FU) visits Week 30 and 36. Spot urine sample was provided by the participants on site. The 24 hour urine collection started with the second morning void and ended with the first morning void on the following day; generally, 24 hour urine collection was initiated the day prior to the study visit. Baseline was defined as the value obtained at Week 0. Percent change from Baseline was calculated as change from Baseline value divided by Baseline value multiplied by 100. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Baseline (Week 0), Week 2, Week 4, Week 8, Week 16, Week 24, End of study, Week 30 and Week 36|All Subject Population: all eligible participants who received at least one dose of investigational drug.||Percent change||Standard Deviation|Mean
652730|NCT02000440|Secondary|Number of Participants Meeting the Definition of Responder for Reduction in Proteinuria at Any Time During the Treatment Phase (Week 2 to Week 24)|Proteinuria is defined as the presence of an excess of serum proteins in the urine. Participant was considered as responder on achieving >=50 percent reduction in proteinuria from Baseline (measured as 24 hour total protein) and also having a stable renal function of >=70 percent of Baseline eGFR at any time during the treatment phase of the study. Reduction in proteinuria assessment at any time during the treatment phase of the study was done by utilizing a responder analysis.|Any time during the treatment phase (Week 2 to Week 24)|Completed Treatment Population||Participants|||Number
652731|NCT02000440|Primary|Number of Participants Meeting the Definition of Responder for Reduction in Proteinuria at the Indicated Time Points|Proteinuria is defined as the presence of an excess of serum proteins in the urine. Participant was considered as a responder on achieving >=50 percent reduction in proteinuria from Baseline (measured as 24 hour total protein) and also having a stable renal function of >=70 percent of Baseline estimated glomerular filtration rate (eGFR) at end of treatment (>=16 Weeks). Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Week 2, Week 4, Week 8, Week 16 and Week 24|Completed Treatment Population: comprised of participants who had completed >=16 weeks of losmapimod treatment or who withdrew from the treatment. Participants who withdrew prior to Week 16 were considered as non-responders.||Participants|||Number
652732|NCT02000427|Secondary|Steady State Concentration of Blinatumomab||Cycle 1, day 8, 6 to 8 hours after the dose step to 28 μg/day, and Cycle 2, day 1, 6 to 8 hours after blinatumomab infusion|Participants with available serum concentration data||pg/mL||Geometric Coefficient of Variation|Geometric Mean
652733|NCT02000427|Secondary|Number of Participants Who Developed Anti-blinatumomab Antibodies|Anti-blinatumomab binding antibodies were evaluated with a validated blinatumomab anti-drug antibody assay with the electrochemiluminescence detection technology.|Day 29 of each treatment period and 30 days after the last dose|Participants with available post-baseline antibody results||participants|||Number
652734|NCT02000427|Secondary|Number of Participants With Adverse Events|"Adverse events (AEs) were graded for severity according to the CTCAE version 4.0, where Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.
Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living.
Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living.
Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE. Treatment-related adverse events (TRAEs) were those assessed by the investigator as possibly related to blinatumomab based on response to the question: Is there a reasonable possibility that the event may have been caused by blinatumomab or other protocol-specified therapies/procedures?"|From the first dose of blinatumomab until 30 days after the last dose, up to the cut-off date of 20 May 2015; the median duration of treatment was 53.8 days.|All participants who received an infusion of blinatumomab||participants|||Number
652735|NCT02000427|Secondary|100-Day Mortality After Allogeneic Hematopoietic Stem Cell Transplant|"The analysis of 100-day mortality after allogeneic HSCT was assessed for participants who received an allogeneic HSCT while in remission (CR/CRh*) after 2 cycles of blinatumomab treatment and did not receive any additional antileukemic treatment. 100-day mortality after allogeneic HSCT was calculated relative to the date of allogeneic HSCT.
The 100-day mortality rate after allogeneic HSCT was defined as the percentage of participants having died up to 100 days after allogeneic HSCT estimated using the estimated time to death in percent calculated by Kaplan-Meier methods. Participants alive were censored on the last documented visit date or the date of the last phone contact when the patient was last known to have been alive."|From the date of allogeneic HSCT until the data cut-off date of 20 May 2015; median observation time was 3.2 months.|Participants who received allogeneic HSCT and were in remission with a CR/CRh* after 2 cycles of treatment and received the transplant without receiving any additional antileukemic medication.||percentage of participants||95% Confidence Interval|Number
652749|NCT01999894|Primary|Number of Patients Who Experienced a Treatment-emergent Adverse Event (TEAE)|Number of patients who experienced one or more TEAEs during the study|From Visit 1 (Week 1) to 30 days after Visit 8 (Week 48)|The Safety Population consists of 102 enrolled patients who received at least one dose of study drug.||participants|||Number
652738|NCT02000427|Secondary|Percentage of Participants With Complete Remission/Complete Remission With Partial Hematological Recovery/Complete Remission With Incomplete Hematological Recovery (CR/CRh*/CRi) During the First Two Treatment Cycles|"Efficacy was evaluated via a central bone marrow aspiration and local peripheral blood counts.
Complete remission was defined as meeting the following criteria:
less than or equal to 5% blasts in the bone marrow;
no evidence of disease;
full recovery of peripheral blood counts: platelets > 100,000/μl, and absolute neutrophil count (ANC) > 1000/μl.
Complete remission with partial hematological recovery was defined as meeting the following criteria:
less than or equal to 5% blasts in the bone marrow;
no evidence of disease;
partial recovery of peripheral blood counts: platelets > 50,000/μl, and ANC > 500/μl.
Complete remission with incomplete hematologic recovery was defined as meeting all of the following criteria:
less than or equal to 5% blasts in the bone marrow;
no evidence of disease;
incomplete recovery of peripheral blood counts: platelets > 100,000/μl or ANC > 1000/μl.
Participants without a post-baseline disease assessment were considered non-responders."|Approximately 12 weeks, as of the data cut-off date of 20 May 2015|All participants who received an infusion of blinatumomab||percentage of participants||95% Confidence Interval|Number
652739|NCT02000427|Secondary|Percentage of Participants With Complete Remission With Partial Hematological Recovery (CRh*) During the First Two Treatment Cycles|"Participants were evaluated for efficacy at the end of each treatment cycle via a central bone marrow aspiration and local peripheral blood counts.
Complete remission with partial hematological recovery (CRh*) was defined as meeting all 3 of the following criteria:
less than or equal to 5% blasts in the bone marrow;
no evidence of disease;
partial recovery of peripheral blood counts: platelets > 50,000/μl, and ANC > 500/μl.
Participants without a post-baseline disease assessment were considered non-responders."|Approximately 12 weeks, as of the data cut-off date of 20 May 2015|All participants who received an infusion of blinatumomab||percentage of participants||95% Confidence Interval|Number
652740|NCT02000427|Secondary|Percentage of Participants With Complete Remission (CR) During the First Two Treatment Cycles|"Participants were evaluated for efficacy at the end of each treatment cycle via a central bone marrow aspiration and local peripheral blood counts.
Complete remission was defined as meeting all 3 of the following criteria:
less than or equal to 5% blasts in the bone marrow;
no evidence of disease;
full recovery of peripheral blood counts: platelets > 100,000/μl, and absolute neutrophil count (ANC) > 1000/μl.
Participants without a post-baseline disease assessment were considered non-responders."|Approximately 12 weeks, as of the data cut-off date of 20 May 2015|All participants who received an infusion of blinatumomab||percentage of participants||95% Confidence Interval|Number
652741|NCT02000427|Secondary|Duration of CR or CRh* Response|Duration of response was measured for participants in remission (CR/CRh*), and was measured from the time the participant first achieved remission until first documented relapse or death from disease progression. Participants without a documented relapse (hematological or extramedullary) and who did not die were censored at the time of the last bone marrow assessment or the last survival follow-up visit to confirm remission. Participants who died without having reported hematological relapse or without showing any clinical sign of disease progression were censored on their date of death.|Up to the data cut-off date of 20 May 2015; median observation time was 7.0 months|Participants who received an infusion of blinatumomab and with a CR or CRh* response during the first 2 treatment cycles.||months||95% Confidence Interval|Median
652742|NCT02000427|Secondary|Percentage of Participants With Minimal Residual Disease (MRD) Remission During the First 2 Cycles of Treatment|"Bone marrow samples were evaluated for MRD remission by a central laboratory using bcr-abl fusion gene reverse transcription polymerase chain reaction (RT-PCR).
An MRD response was defined as MRD < 10^-4 measured by PCR. Participants with no post-baseline MRD assessment were considered non-responders."|Approximately 12 weeks|All participants who received an infusion of blinatumomab.||percentage of participants||95% Confidence Interval|Number
652743|NCT02000427|Primary|Percentage of Participants With Complete Remission/Complete Remission With Partial Hematological Recovery (CR/CRh*) During the First Two Treatment Cycles|"Participants were evaluated for efficacy at the end of each treatment cycle via a central bone marrow aspiration and local peripheral blood counts.
Complete remission was defined as meeting all 3 of the following criteria:
less than or equal to 5% blasts in the bone marrow;
no evidence of disease
full recovery of peripheral blood counts: platelets > 100,000/μl, and absolute neutrophil count (ANC) > 1000/μl.
Complete remission with partial hematological recovery (CRh*) was defined as meeting all 3 of the following criteria:
less than or equal to 5% blasts in the bone marrow
no evidence of disease
partial recovery of peripheral blood counts: platelets > 50,000/μl, and ANC > 500/μl.
Participants without a post-baseline disease assessment were considered non-responders."|Approximately 12 weeks, as of the data cut-off date of 20 May 2015|All participants who received an infusion of blinatumomab.||percentage of participants||95% Confidence Interval|Number
652744|NCT02000154|Secondary|Cytogenetic Response|"NCA (not considered assessable)
no evidence of cytogenetic response, defined in the International Working Group 2006 response criteria for myelodysplastic syndrome."|Up to 20 weeks|||participants|||Number
652745|NCT02000154|Secondary|Hematologic Improvement|"NCA (not considered assessable)
no evidence of hematologic improvement -erythroid, -platelet, -neutrophil, progressive disease, or relapse, defined in the International Working Group 2006 response criteria for myelodysplastic syndrome."|Up to 20 weeks|||participants|||Number
652746|NCT02000154|Secondary|Serious Adverse Events|Total number affected any serious adverse events|Up to 20 weeks|||participants|||Number
652747|NCT02000154|Secondary|Disease Response Assessment|"Disease progression
According to the International Working Group 2006 response criteria for Myelodysplastic Syndrome, disease progression is defined as no evidence of complete remission (CR), partial remission, marrow CR, stable disease, or failure, and as meeting one of the following conditions.
when pretreatment percentage of bone marrow blasts < 5%: ≥ 50% increase to > 5%.
when pretreatment percentage of bone marrow blasts 5 to 10%: ≥ 50% increase to > 10%.
when pretreatment percentage of bone marrow blasts 10 to 20%: ≥ 50% increase to > 20%.
when pretreatment percentage of bone marrow blasts 20 to 30%: ≥ 50% increase to > 30%.
other: at least one of the following: decrease to ≤ 50% of neutrophil or platelet count at maximum response, ≥ 2 g/dL decrease in Hgb or transfusion dependence (in the absence of other factors, such as infection, gastrointestinal bleeding, or hemolysis)."|Up to 20 weeks|||participants|||Number
652748|NCT02000154|Primary|Adverse Events|Total number affected by any adverse events (details are presented in adverse event section)|Up to 20 weeks|||participants|||Number
652750|NCT01999400|Secondary|The AUC of Metabolite (N-acetyl-mesalamine) in Distal Jejunum|The AUC is the area under the concentration-time curve from time 0 to 7 hours. The data are organized by the different drug formulations of mesalamine, which include Pentasa, Apriso, and Lialda. The AUC is measured in units of micromoles of mesalamine per liter of plasma (µM) multiplied by time in hours (µM*h).The AUC results are reported over the time-period because this provides a more meaningful comparison of potential differences in the bioequivalence of formulations. The solution formulation (Delzicol) was not administered in this portion of the study. Therefore no results pertaining to the solution formulation are included in this outcome measure.|0 hours pre-dose and up to 7 hours post-dose|The number of subjects that were administered Pentasa, Apriso, Lialda were 10, 7, and 9, respectively. However, we were only able to collect gastrointestinal fluid from the distal jejunum for only 3 subjects in each of these arms due to the placement of the gastrointestinal tube.||uM*h||Standard Deviation|Mean
652751|NCT01999400|Secondary|The AUC of Mesalamine in Distal Jejunum|The AUC is the area under the concentration-time curve from time 0 to 7 hours. The data are organized by the different drug formulations of mesalamine, which include Pentasa, Apriso, and Lialda. The AUC is measured in units of micromoles of mesalamine per liter of plasma (µM) multiplied by time in hours (µM*h).The AUC results are reported over the time-period because this provides a more meaningful comparison of potential differences in the bioequivalence of formulations. The solution formulation (Delzicol) was not administered in this portion of the study. Therefore no results pertaining to the solution formulation are included in this outcome measure.|0 hours pre-dose and up to 7 hours post-dose|The number of subjects that were administered Pentasa, Apriso, Lialda were 10, 7, and 9, respectively. However, we were only able to collect gastrointestinal fluid from the distal jejunum for only 3 subjects in each of these arms due to the placement of the gastrointestinal tube.||uM*h||Standard Deviation|Mean
652752|NCT01999400|Primary|The AUC of Metabolite (N-acetyl-mesalamine) in Plasma|The AUC is the area under the concentration-time curve from time 0 to last time point. The data are organized by the different drug formulations of mesalamine, which include Pentasa (0 to 72 hours), Apriso (0 to 72 hours), Lialda (0 to 96 hours), and Delzicol (0 to 24 hours). The AUC is measured in units of nanomoles of N-acetyl-mesalamine per liter of plasma (nM) multiplied by time in hours (nM*h). The AUC results are reported over the time-period because this provides a more meaningful comparison of potential differences in the bioequivalence of formulations.|0 hours pre-dose and up to 96 hours post-dose|||nM*h||Standard Deviation|Mean
652753|NCT01999400|Primary|The AUC of Mesalamine in Plasma|The AUC is the area under the concentration-time curve from time 0 to last time point. The data are organized by the different drug formulations of mesalamine, which include Pentasa (0 to 72 hours), Apriso (0 to 72 hours), Lialda (0 to 96 hours), and Delzicol (0 to 24 hours). The AUC is measured in units of nanomoles of mesalamine per liter of plasma (nM) multiplied by time in hours (nM*h). The AUC results are reported over the time-period because this provides a more meaningful comparison of potential differences in the bioequivalence of formulations.|0 hours pre-dose and up to 96 hours post-dose|||nM*h||Standard Deviation|Mean
652754|NCT01999348|Secondary|Physician Assessment of Patient Compliance Compared to Previous Treatment on a 3-Point Scale|The physician assessed patient compliance with Ganfort® UD compared to previous treatment using a 3-point scale where: 1=better (best), 2=equal and 3=worse. The number of participants in each category is reported.|Final Visit (Week 8 to 12)|All participants from the Per-protocol population, all treated participants who had no major protocol violations, who received previous treatment.||participants|||Number
652755|NCT01999348|Secondary|Percentage of Patients Prescribed by the Physician to Continue Treatment|The percentage of participants who continued treatment with Ganfort® UD after Week 12.|Final Visit (Week 8 to 12)|Per-protocol population included all treated participants who had no major protocol violations.||percentage of participants|||Number
652756|NCT01999348|Secondary|Percentage of Patients Who Discontinued Treatment|The percentage of participants who discontinued treatment with Ganfort® UD up to the Week 12 Final Visit|12 Weeks|Per-protocol population included all treated participants who had no major protocol violations.||percentage of participants|||Number
652757|NCT01999348|Secondary|Physician Assessment of Tolerability on a 4-Point Scale|The physician assessed the patient’s tolerability of Ganfort® UD using a 4-point scale where: 1=very good (best), 2=good, 3=moderate and 4=poor. The number of participants in each category is reported.|Final Visit (Week 8 to 12)|Per-protocol population included all treated participants who had no major protocol violations.||participants|||Number
652758|NCT01999348|Secondary|Patient Assessment of Tolerability on a 4-Point Scale|The patient assessed the tolerability of Ganfort® UD using a 4-point scale where: 1=very good (best), 2=good, 3=moderate and 4=poor. The number of participants in each category is reported.|Final Visit (Week 8 to 12)|Per-protocol population included all treated participants who had no major protocol violations.||participants|||Number
652759|NCT01999348|Secondary|Physician Assessment of IOP-Lowering Effect in the Study Eye Using a 3-Point Scale|The physician assessed the effectiveness of Ganfort® UD with regard to IOP changes from Baseline using a 3-point scale where: 1=Better than expected (best), 2=As expected and 3=Worse than expected. The number of participants in each category is reported.|Baseline, Final Visit (Week 8 to 12)|Per-protocol population included all treated participants who had no major protocol violations.||participants|||Number
652760|NCT01999348|Primary|Change From Baseline in Intraocular Pressure (IOP) in the Study Eye|IOP is a measure of the fluid pressure inside the study eye. A result at the Final Visit that is lower than the result at Baseline indicates a reduction in IOP (improvement).|Baseline, Final Visit (Week 8 to 12)|Participants from the Per-protocol population, all treated participants who had no major protocol violations, with complete data available at Baseline and Final Visit for analyses.||mmHg||Standard Deviation|Mean
652761|NCT01999231|Secondary|the Number of Participants Who Appear the Induration and/or Redness 96h After Application of ESAT6-CFP10|We check the immune response( induration and/or redness) at 96h after application of ESAT6-CFP10 with vernier caliper. Using the standardized vernier caliper, measured transverse diameter and the longitudinal diameter of induration and/or redness in skin test parts if any participants appear induration and/or redness after application of ESAT6-CFP10.|96h after application of ESAT6-CFP10|||participants|||Number
652785|NCT01998919|Secondary|Percentage of Participants With Confirmed CR or PR as Assessed by RECIST|CR=disappearance of all target lesions; PR=at least a 30% decrease in sum of LD of target lesions, taking as reference the baseline sum LD.|Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-Study Phases|FAS||percentage of participants||95% Confidence Interval|Number
652762|NCT01999231|Secondary|the Number of Participants Who Appear the Induration and/or Redness 72h After Application of ESAT6-CFP10|We check the immune response( induration and/or redness) at 72h after application of ESAT6-CFP10 with vernier caliper. Using the standardized vernier caliper, measured transverse diameter and the longitudinal diameter of induration and/or redness in skin test parts if any participants appear induration and/or redness after application of ESAT6-CFP10.|72h after application of ESAT6-CFP10|||participants|||Number
652763|NCT01999231|Secondary|the Number of Participants Who Appear the Induration and/or Redness 48h After Application of ESAT6-CFP10|We check the immune response( induration and/or redness) at 48h after application of ESAT6-CFP10 with vernier caliper. Using the standardized vernier caliper, measured transverse diameter and the longitudinal diameter of induration and/or redness in skin test parts if any participants appear induration and/or redness after application of ESAT6-CFP10.|48h after application of ESAT6-CFP10|||participants|||Number
652764|NCT01999231|Secondary|the Number of Participants Who Appear the Induration and/or Redness 24h After Application of ESAT6-CFP10|We check the immune response( induration and/or redness) at 24h after application of ESAT6-CFP10 with vernier caliper. Using the standardized vernier caliper, measured transverse diameter and the longitudinal diameter of induration and/or redness in skin test parts if any participants appear induration and/or redness after application of ESAT6-CFP10.|24h after application of ESAT6-CFP10|||participants|||Number
652765|NCT01999231|Secondary|the Number of Participants Who Appear the Induration and/or Redness 2h After Application of ESAT6-CFP10|We check the immune response( induration and/or redness) at 2h after application of ESAT6-CFP10 with vernier caliper. Using the standardized vernier caliper, measured transverse diameter and the longitudinal diameter of induration and/or redness in skin test parts if any participants appear induration and/or redness after application of ESAT6-CFP10.|within 2h after application of ESAT6-CFP10|Induration and/or redness is our main immune response of ESAT6-CFP10.||participants|||Number
652766|NCT01999231|Primary|the Cases of Adverse Events With Participant Injection of ESAT6-CFP10|The main examination items :vital signs (breathing, heart rate, blood pressure, body temperature ) of each volunteer at 15min, 30min, 1h, 2h, 4h, 8h, 24h, 48h, 72h, 96h after injection, skin reactivity (redness and/or induration) of injection sites,local reaction ( rash, pain, itching, and skin mucous membranes ) ,a variety of adverse events,routine blood,routine urine, liver and kidney function, ECG and chest X-ray films before and 7 days after intradermal injection .|within 7 days after the injections|ESAT6-CFP10 allergen similar to TB-PPD(Tuberculin purified protein derivative ), main ingredients are protein and can cause specific skin allergy in the injection site ( such as redness, swelling, induration, blisters), besides other local reactions, is still listed as adverse events .||cases|||Number
652767|NCT01999192|Other Pre-specified|Evaluation of Safety, Patient Reported Outcomes & Blood Tests.||up to 48 weeks||||||
652768|NCT01999192|Other Pre-specified|Pharmacokinetics|AUC, Cmax, Tmax at baseline, and at Week (W) 2/Visit (V) 4, W4/V5, W8/V7, W12/V8, W24/V10, W3/V122, W48 (end of Treatment [EoT]/ early termination ET), and at follow-up (post EoT/post ET).|up to 48 weeks||||||
652769|NCT01999192|Secondary|DAS28 Score Individual Components||up to 48 weeks||||||
652770|NCT01999192|Secondary|ACR Score Individual Components||up to 48 weeks||||||
652771|NCT01999192|Secondary|EULAR Response||up to 48 weeks||||||
652772|NCT01999192|Secondary|DAS28||up to 48 weeks||||||
652773|NCT01999192|Secondary|Clinical Disease Activity Index [CDAI] ≤10||week 12 & 24||||||
652774|NCT01999192|Secondary|Simple Disease Activity Index [SDAI] ≤11||week 12 & 24||||||
652775|NCT01999192|Secondary|ACR Score||up to 48 weeks||||||
652776|NCT01999192|Secondary|Proportions of Subjects With Low Disease Activity DAS28 ≤3.2||Week 12 & Week 24||||||
652777|NCT01999192|Secondary|Proportions of Subjects With an Disease Activity Score DAS28 <2.6||Week 12 & Week 24||||||
652778|NCT01999192|Secondary|Proportions of Subjects With an ACR 50 & 70 Response.||Week 12 & Week 24||||||
652779|NCT01999192|Secondary|Proportions of Subjects With an ACR 20 Response.||Week 24||||||
652780|NCT01999192|Primary|The Proportion of Subjects Who Achieve an ACR20 at Week 12 Following Treatment With Tregalizumab + MTX Compared With Subjects Treated on Placebo + MTX|"The primary efficacy variable was the proportion of subjects with an ACR20 response after 12 weeks of double-blind treatment with the study medication.
The analysis of the primary endpoint was performed using observed cases (OC) on the FAS."|Week 12|"The analysis of the primary endpoint was performed using observed cases (OC) on the FAS.
Full analysis set (FAS): All subjects entered into the study who received at least one dose of study medication and have at least one post-baseline assessment."||percentage of Subjects|||Number
652781|NCT01998919|Secondary|Overall Survival|Overall Survival (OS) was defined as the time from the date of randomization to the date of death, regardless of the cause of death. Participants who were alive at the time of the analysis were censored at the date of the last follow-up assessment.|Date of randomization until date of death or date of last follow-up assessment|FAS Population||weeks||95% Confidence Interval|Median
652782|NCT01998919|Secondary|Progression-Free Survival (PFS)|PFS was defined as the interval between the day of randomization and the date of first documentation of progressive disease or date of death, whichever came first.|Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-Study Phases|FAS Population||weeks||95% Confidence Interval|Median
652783|NCT01998919|Secondary|Time to Progression|Time to progression was defined as the interval between the day of randomization and the first documentation of PD. Participants who were withdrawn from the study without documented progression and for whom there exists CRF evidence that evaluations have been made, were censored at 1) the date of the last tumor assessment, 2) last date in the drug log, or 3) last date of follow-up when the participant was known to be progression free, whichever was last. Participants without post-baseline tumor assessments but known to be alive were censored at the time of randomization.|Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-Study Phases|FAS Population||weeks||95% Confidence Interval|Median
652784|NCT01998919|Secondary|Duration of Response|Duration of Response was defined similarly for complete responders and partial responders. CR was defined as the date CR was first recorded to the date on which PD was first noted or date of death. PR was defined as the date the first PR was recorded to the date of the first observation of PD or date of death.|Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-study Phases|FAS; only participants with CR or PR were included in the analysis.||weeks||95% Confidence Interval|Median
652787|NCT01998919|Primary|Percentage of Participants With Non-Progression at Week 8 as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)|Non-progression defined as documented best overall tumor response of complete response (CR), partial response (PR), or stable disease (SD; where SD was maintained for greater than [>]8 weeks) per RECIST. Investigator's assessment of response used in all analyses. CR equals (=)disappearance of all target lesions; PR=at least a 30 percent (%) decrease in sum of longest diameter (LD) of target lesions, taking as reference the baseline sum LD; SD=neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression, taking as reference smallest sum LD since treatment started.|Week 8|FAS; for analysis, participants were assigned the treatment group to which they were randomized, regardless of the treatment they actually received.||percentage of participants||95% Confidence Interval|Number
652788|NCT01998906|Secondary|Percentage of Participants Surviving at 3 Years||BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter|FAS||percentage of participants||95% Confidence Interval|Number
652789|NCT01998906|Primary|Percentage of Participants Event Free at 3 Years||BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter|FAS||percentage of participants||95% Confidence Interval|Number
652790|NCT01998906|Secondary|Percentage of Participants Surviving at 2 Years||BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter|FAS||percentage of participants||95% Confidence Interval|Number
652791|NCT01998906|Primary|Percentage of Participants Event Free at 2 Years||BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter|FAS||percentage of participants||95% Confidence Interval|Number
652792|NCT01998906|Secondary|Percentage of Participants Surviving at 1 Year||BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter|FAS||percentage of participants||95% Confidence Interval|Number
652793|NCT01998906|Secondary|Overall Survival|OS was defined as the time from the date of randomization to the date of the death due to any cause.|BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter|FAS||months||95% Confidence Interval|Median
652794|NCT01998906|Primary|Percentage of Participants Event Free at 1 Year||BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter|FAS||percentage of participants||95% Confidence Interval|Number
652795|NCT01998906|Primary|Event-Free Survival|The median time, in months, between randomization and date of documented occurrence of an EFS event.|BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter|FAS||months||95% Confidence Interval|Median
652796|NCT01998906|Secondary|Overall Survival (OS) - Percentage of Participants With an Event|OS was defined as the time from the date of randomization to the date of the death due to any cause.|BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter|FAS||percentage of participants|||Number
652797|NCT01998906|Secondary|Percentage of Participants Achieving Either Complete Response (CR) or Partial Response (PR) According to Modified Response Evaluation Criteria in Solid Tumors (RECIST) Criteria|Assessments were made based on objective tumor measurements of the lesions as recorded in the case report form. In inflammatory cancer, progressive disease (PD) was defined as progression of any of the 2 signs of breast edema and erythema. In non-inflammatory cancer, PD was concluded if either the investigator judged the participant as having progressed at any time prior to surgery, or there was at least a 20% increase in the sum of target lesions (TLs), any new lesion, or clear progression of any nontarget lesion (NTLs). Clear progression of any NTL was defined as at least a 20% increase in the sum of NTLs compared to BL. PR was defined as at least a 30% decrease from BL in the sum of the longest diameter of TLs. CR was defined as no PD as assessed by the investigator and complete disappearance of all lesions.|BL, Presurgery: Day 1 of Cycles 1-10|FAS||percentage of participants||95% Confidence Interval|Number
652798|NCT01998906|Secondary|Percentage of Participants With Total Pathological Complete Response (tpCR)|tpCR was defined as a determination of bpCR and an absence of positive axillary nodes on pathology.|BL, Day 1 of Cycles 1-10 (pre-surgery)|FAS||percentage of participants||95% Confidence Interval|Number
652799|NCT01998906|Secondary|Percentage of Participants With Breast Pathological Complete Response (bpCR)|bpCR was defined as an absence of any invasive cancer cell of the primary tumor at the time of major surgery after neoadjuvant chemotherapy with and without trastuzumab.|BL, Day 1 of Cycles 1-10 (pre-surgery)|FAS||percentage of participants||95% Confidence Interval|Number
652800|NCT01998906|Primary|Event-Free Survival (EFS) - Percentage of Participants With an Event|EFS was defined as the time between randomization and date of documented occurrence of disease recurrence or progression (local, regional, distant or contralateral) or death due to any cause.|Baseline (BL), Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter|The full analysis set (FAS) included all participants who were randomized in the main study or registered in the parallel observational arm.||percentage of participants|||Number
652811|NCT01998880|Secondary|Event Free Survival|Event-free survival (EFS) was defined as the time between date of randomization and the date of disease progression/relapse, death, or start of a new anti-leukemic therapy. Progressive disease required at least one of the following: ≥50% increase in the absolute number of lymphocytes, appearance of new palpable lymph nodes (>15 mm in longest diameter) or any new extra nodal lesion, ≥50% increase in the longest diameter of any previous site of clinically significant lymphadenopathy, ≥50% increase in the enlargement of the liver and/or spleen, Transformation to a more aggressive histology or After treatment, the progression of any cytopenia (a decrease of hemoglobin levels >20 g/L or <10 g/dL or a decrease of platelet counts >50% or <100 x 10^9/L or by a decrease of neutrophil counts >50% or <1.0 x 10^9/L).|Randomization to clinical cutoff (median observation 15.2 months)|Intent-to-treat population included all randomized participants. Patients without EFS events were censored.||Months||95% Confidence Interval|Median
652801|NCT01998893|Secondary|Number of Participants With a Clinical Response to Re-Treatment|Clinical response was defined as the best response after the second 4 weeks of treatment cycle by the following categories: CR, PR, MR, SD, and PD. CR was defined as the complete disappearance of all objective disease findings, including enlarged lymph nodes, hepatomegaly, and splenomegaly for at least 4 weeks, and a normalization of blood counts with granulocytes >1,500/μL, Hb >12 g/dL, and platelets >100,000/μL. PR was defined as <50% regression of all measurable and evaluable lymphoma manifestations (sum of the products of the 2 largest diameters vertical to each other) for at least 4 weeks without the appearance of new manifestations, and normalization of blood counts. MR was defined as tumor regression ≥25% and <50%. SD was defined as tumor regression <25%, no new manifestations, and progression ≤25%. PD was defined as no new lymphoma associated symptoms or an increase in the size of manifestations by more than 25%.|First application in the second treatment cycle until progression of disease. The median length of follow-up was 4.6 months (range: 0.5-20.6 months).|Participants in the ITT population who began a second cycle of treatment.||participants|||Number
652802|NCT01998893|Secondary|Overall Survival (OS)|OS was defined as the time, in months, between enrollment into the study and death, due to any cause. Participants who were not reported as having died at the time of the analysis were censored using the date they were last known to be alive.|Enrollment into study until end of follow-up or death. The median length of follow-up was 6.6 months (range: 0-97.8 months)|ITT population||months||95% Confidence Interval|Median
652803|NCT01998893|Secondary|Time to Progression|The median time, in months, from the start of treatment (first application) until detection of PD.|Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)|ITT population||months||95% Confidence Interval|Median
652804|NCT01998893|Secondary|Duration of Remission|Median time, in months, between the documentation of CR or PR and PD in clinical responders.|Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)|Participants in the ITT population with CR or PR after the first treatment cycle.||months||95% Confidence Interval|Median
652805|NCT01998893|Secondary|Time to Best Response|The median time, in months, from start of the treatment (first application) until best response (PR or CR).|Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)|ITT population; only participants with at least one application of study treatment within the first 4 weeks of treatment were included in the analysis.||months||95% Confidence Interval|Median
652806|NCT01998893|Secondary|Number of Participants With a Clinical Response|Clinical response was defined as the best response after the first 4 weeks of treatment cycle by the following categories: CR, PR, minor response (MR), stable disease (SD), and progressive disease (PD). CR was defined as the complete disappearance of all objective disease findings, including enlarged lymph nodes, hepatomegaly, and splenomegaly for at least 4 weeks, and a normalization of blood counts with granulocytes >1,500/μL, Hb >12 g/dL, and platelets >100,000/μL. PR was defined as <50% regression of all measurable and evaluable lymphoma manifestations (sum of the products of the 2 largest diameters vertical to each other) for at least 4 weeks without the appearance of new manifestations, and normalization of blood counts. MR was defined as tumor regression ≥25% and <50%. SD was defined as tumor regression <25%, no new manifestations, and progression ≤25%. PD was defined as no new lymphoma associated symptoms or an increase in the size of manifestations by more than 25%.|Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)|ITT population||participants|||Number
652807|NCT01998893|Primary|Percentage of Participants With a Complete Remission (CR) or Partial Remission (PR)|Percentage of participants with a CR, PR at the end of the first cycle of treatment (Week 4). CR was defined as the complete disappearance of all objective disease findings, including enlarged lymph nodes, hepatomegaly, and splenomegaly for at least 4 weeks, and a normalization of blood counts with granulocytes >1.500/ microliter (µL), hemoglobin (Hb) >12 grams per deciliter (g/dL), and platelets >100,000/µL. PR was defined as a less than (<) 50% regression of all measurable and evaluable lymphoma manifestations (sum of the products of the 2 largest diameters vertical to each other) for at least 4 weeks without the appearance of new manifestations, and normalization of blood counts.|Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)|ITT population||percentage of participants||95% Confidence Interval|Number
652808|NCT01998880|Secondary|Percentage of Participants With Molecular Remission at the End of Treatment|Molecular remission was defined as a minimal residual disease (MRD)-negative result at the end of treatment (assessment that occurred between 56 days and 6 months of last treatment). Molecular remission was assessed for all patients using a blood sample. Additionally, a bone marrow sample was obtained from patients whom the investigator assumed to have a complete response, consistent with the IWCLL guidelines. A combined analysis of blood and bone marrow results was conducted. A patient was considered MRD negative if result was less than 1 CLL cell in 10000 leukocytes (MRD value < 0.0001) based on the method of allele specific polymerase chain reaction (ASO-PCR).|Randomization to clinical cutoff (median observation 15.2 months)|Participants from the Intent-to-treat population (all randomized participants) with MRD data available for analysis. Participants who did not reach the 3 month Follow-up visit at the time of the clinical cutoff are excluded.||Percentage of participants||95% Confidence Interval|Number
652809|NCT01998880|Secondary|Percentage of Participants With End of Treatment Response (EOTR)|EOTR was the first response assessment 56 days from the last dose according to the International Workshop on Chronic Lymphocytic Leukaemia (IWCLL) guidelines. CR required: Peripheral blood lymphocytes below 4 x 10^9/L, Absence of significant lymphadenopathy, No hepatomegaly, No splenomegaly, Absence of disease, Blood counts above the following values (Neutrophils >1.5 x 10^9/L, Platelets >100 x 10^9/L, Hemoglobin >11g/dL) and Bone marrow at least normocellular for age. CRi was CR with incomplete bone marrow recovery. PR required the following for at least 2 months from end of treatment: ≥50% decrease in peripheral blood lymphocyte count from the pre-treatment value AND Either a ≥ 50% reduction in lymphadenopathy OR ≥50% reduction of liver enlargement OR ≥50% reduction of spleen enlargement PLUS at least one of the following: Neutrophils >1.5 x 10^9/ or ≥50% increase, Platelets >100 x 10^9/L or ≥50% increase, Hemoglobin 11 g/dL or ≥50% increase.|Randomization to clinical cutoff (median observation 15.2 months)|Participants from the Intent-to-treat population (all randomized participants) with data available for analysis. Participants who did not reach the 3 month Follow-up visit at the time of the clinical cutoff are excluded.||Percentage of participants||95% Confidence Interval|Number
652813|NCT01998880|Primary|Progression-free Survival (PFS)|PFS was defined as the time from randomization to the first occurrence of progression, relapse, or death from any cause as assessed by the investigator. Progressive disease required at least one of the following: ≥50% increase in the absolute number of lymphocytes, appearance of new palpable lymph nodes (>15 mm in longest diameter) or any new extra nodal lesion, ≥50% increase in the longest diameter of any previous site of clinically significant lymphadenopathy, ≥50% increase in the enlargement of the liver and/or spleen, Transformation to a more aggressive histology or After treatment, the progression of any cytopenia (a decrease of hemoglobin levels >20 g/L or <10 g/dL or a decrease of platelet counts >50% or <100 x 10^9/L or by a decrease of neutrophil counts >50% or <1.0 x 10^9/L).|Randomization to clinical cutoff (median observation 15.2 months)|Intent-to-treat population included all randomized participants. Patients without PFS events were censored.||Months||95% Confidence Interval|Median
652814|NCT01998737|Secondary|Number of Participants That Would Require Additional DXA Examination to Confirm Diagnosis|The previously determined thresholds have been applied. The results show amount of subject whose DI value is between the thresholds. These subjects would need DXA measurement to verify diagnosis.|3 years|||Participants|||Count of Participants
652815|NCT01998737|Primary|Specificity of the Density Index Against Dual Energy X-ray Absorptiometry for Detecting Osteoporosis|The thresholds for the Density Index (DI) in osteoporosis diagnostics in comparison to dual energy x-ray absorptiometry (DXA) are evaluated in independent population.|3 years|||percentage of true negatives|||Number
652816|NCT01998737|Primary|Sensitivity of the Density Index Against Dual Energy X-ray Absorptiometry for Detecting Osteoporosis|The thresholds for the Density Index (DI) in osteoporosis diagnostics in comparison to dual energy x-ray absorptiometry (DXA) are evaluated in independent population.|3 years|||percentage of true positives|||Number
652817|NCT01998581|Secondary|Change From Baseline in Subject Satisfaction With Lips on the Lip Module of the FACE-Q Questionnaire|Subjects evaluated satisfaction using the 22 items on the Satisfaction with Lip module of the FACE-Q questionnaire. Scores for each item are combined to create a scale ranging from 0 (worse) to 100 (best). A positive number in change from baseline indicates an improvement, and a negative number in change from baseline indicates a worsening.|Baseline, Month 3|Modified Intent-to-Treat: subjects who were randomized with data at both time points and received at least 1 treatment||Scores on a Scale||95% Confidence Interval|Mean
652818|NCT01998581|Secondary|Percentage of Subjects in the JUVEDERM VOLBELLA® XC Treatment Arm With at Least a 1 Point Improvement From Baseline on the Perioral Lines Severity Scale (POLSS)|The Evaluating Investigator evaluated the perioral lines severity using the 4-point POLSS where None=No lines; Mild=Few, shallow lines; Moderate=Some, moderate lines; and Severe=Many, deep lines or crevices. The percentage of subjects with at least a 1-point improvement is reported. In accordance with the analysis plan, the analysis with responder rate and 95% Confidence Interval was performed for the JUVEDERM VOLBELLA® XC group only.|Baseline, Month 3|Subjects in the JUVEDERM VOLBELLA® XC group who received treatment in perioral lines with a baseline POLSS score of moderate or severe||Percentage of Subjects||95% Confidence Interval|Number
652819|NCT01998581|Primary|Change From Baseline in Evaluating Investigator's Assessment of Lip Fullness on a 5-Point Scale|Lip fullness is assessed by the Evaluating Investigator on the 5-point Lip Fullness Scale 2. Assessments range from 0=minimal flat or nearly flat contour, minimal red lip show (worse) to 4=very marked very significant red lip show, lower lip pout, and upper lip pout (best). A positive number change from baseline indicates improvement and a negative number change from baseline indicates a worsening.|Baseline, Month 3|Modified Intent-to-Treat: subjects who were randomized with a Lip Fullness Scale 2 baseline score of minimal, mild, or moderate and who received at least 1 treatment||Scores on a Scale||Standard Deviation|Mean
652820|NCT01998477|Primary|Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata|Safety was assessed in terms of number of subjects who reported any unsolicited AEs (four weeks after 1st vaccination and up to three weeks after 2nd vaccination), serious adverse events (SAEs), new onset of chronic diseases (NOCD), medically attended AEs and AEs leading to vaccine/study withdrawal after receiving one or two doses of either TIVc or TIV by overall age group (3 to <18 years) and age sub-strata (3 to <9 years and 9 to <18 years)|Day 1 –Day 181(one dose group) Day 1 –Day 209(two dose group)|Analysis was done on unsolicited safety dataset, i.e. all subjects in the Exposed Set who have post-vaccination unsolicited AE records (even if no AEs have occurred)||Subjects|||Number
652821|NCT01998477|Primary|Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata|Safety was assessed in terms of number of the subjects (3 to <6 years,(≥ 6 to < 9 years and 9 to <18 Years of age) who reported solicited local, systemic AEs as well as other solicited AEs after receiving one or two doses of either TIVc or TIV|Day 1 through Day 7 after any vaccination|Analysis was done on safety dataset||Subjects|||Number
652822|NCT01998477|Primary|Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group|Safety was assessed in terms of number of the subjects (3 to < 18 years of age) who reported solicited local, systemic AEs as well as other solicited AEs after receiving one or two doses of either TIVc or TIV|Day 1 through Day 7 post injection 1 and Day 29 through Day 35 post injection 2|Analysis was done on safety dataset, i.e. the subjects in the Exposed Set who provided post-vaccination solicited AE data||Subjects|||Number
652823|NCT01998438|Other Pre-specified|Rate of Reexploration for Bleeding||on the 7th day postoperatively||||||
652824|NCT01998438|Secondary|Number of Participants Needs Allogenic Transfusion||on the 7th day postoperatively||||||
652825|NCT01998438|Primary|Postoperative Blood Loss||24hrs postoperatively|||ml||Inter-Quartile Range|Median
652826|NCT01998399|Other Pre-specified|Discharge Disposition|(Home, other facility, with or without assisted ventilation)|90 days||||||
652827|NCT01998399|Other Pre-specified|Hospital Length of Stay|In days|90 days||||||
652828|NCT01998399|Other Pre-specified|ICU Length of Stay|Includes ICU readmission if during same hospital stay|90 days||||||
652829|NCT01998399|Other Pre-specified|Need for Dialysis|Yes, No|90 days||||||
652830|NCT01998399|Other Pre-specified|Need for Re-instituting Assisted or Mechanical Ventilation After Achieving 48 Consecutive Hours of Unassisted Breathing or Comfort Care Chosen (Withdrawal of Support)|Yes, No|90 days||||||
652831|NCT01998399|Other Pre-specified|Time to Initiation of Unassisted Breathing|Only in patients on mechanical ventilation and assuming patient achieves 48 consecutive hours of unassisted breathing|90 days||||||
652845|NCT01998269|Primary|Measure of Medication Self-Management (MeDS)|The MeDS is an assessment of medication self-management skills. The MeDS tool has 14 questions, the minimum score is 0 (poor medication self-management skills) and the maximum score is 14 (adequate self-management skills). The internal consistency of the scale is .72 (cronbach's alpha), which is considered adequate internal consistency. The MeDS was compared to The Morisky Medication Adherence Scale is one of the most commonly used assessments of medication adherence. It includes 8 questions that assess various factors that can affect medication use, such as forgetfulness, busyness and side effects. Scores range from 0 to 8, with lower scores reflecting better adherence.|cross-sectional, 1 hour interview after clinic visit|||units on a scale||Standard Deviation|Mean
652846|NCT01997905|Secondary|Overall Adverse Event Rate|Overall Adverse Event Rate: Incidence of all device and procedure related adverse events and any neurological related AEs, regardless of attribution, observed through the 3 month and 6 month follow-up assessments, as adjudicated by Independent Physician Adjudicator.|3 month and 6 month post-index procedure|All treated patients.||participants|||Number
652847|NCT01997905|Secondary|Overall Serious Adverse Event Rate|Overall Serious Adverse Event Rate: Incidence of all serious adverse events, regardless of attribution, observed through the 3 month and 6 month follow-up assessments, as adjudicated by Independent Physician Adjudicator.|3 month and 6 month Post Index Procedure|All treated patients.||participants|||Number
652848|NCT01997905|Secondary|Serious Device or Procedure Related Adverse Event Rate|Overall Serious Device or Procedure Related Adverse Event Rate: Incidence of all serious device or procedure related adverse events observed through the 3 month and 6 month follow-up assessments as adjudicated by Independent Physician Adjudicator.|3 month and 6 month post-index procedure|||participants|||Number
652849|NCT01997905|Secondary|Rate of Stroke and Non-CNS Systemic Embolism|"The secondary efficacy endpoints will be a composite of the following events within 3 months and 6 months post-index procedure:
Stroke (ischemic )
Non-CNS (Central Nervous System) systemic embolism."|3 months and 6 months post-index procedure|||participants|||Number
652850|NCT01997905|Primary|Composite Left Atrial Appendage Placement and Exclusion Success|"Primary Efficacy endpoint is a success/failure endpoint with success requiring all of the following:
Patient Technical Success: The ability to successfully implant an AtriClip device at the LAA in a patient.
Intra-Procedural Complete Exclusion of the LAA: The complete exclusion of the LAA defined by lack of fluid communication (<3 mm residual communication with LAA and <10 mm residual pocket) between the LA and LAA, assessed intra-procedurally by TEE.
3 Month Follow-Up Complete Exclusion of the LAA: The complete exclusion of the LAA defined by lack of fluid communication (<3 mm residual communication with LAA and < 10mm residual pocket) between the LA and LAA at >=3 month TEE or CTA evaluation."|Immediate to 3-months post-index procedure|Ten (10) patients were treated, however the AtriClip® device was not implanted in one (1) patient.||participants|||Number
652851|NCT01997905|Primary|Number of Serious Adverse Events Within 30 Days Post-Index Procedure|"The primary safety endpoint consists of the following serious adverse events within 30 days post-index procedure (unless otherwise noted), as adjudicated by Independent Physician Adjudicator:
Serious Injury to the cardiac structure or other body structure deemed to be related to the delivery or placement of the Clip
Cardiac-Related Death, Myocardial Infarction, or Ischemic Stroke
Major bleeding (defined as requiring re-operation and/or transfusion (> 2 U packed red blood cells (PRBC)) within any 24 hour period during the first 2 days post-index procedure or at any time point if attributed to the device/index procedure)."|30 days post-index procedure|||participants|||Number
652852|NCT01997892|Secondary|Percentage of Participants With Hemoglobin Excursions|The percentage of participants with at least one hemoglobin excursion, defined as hemoglobin concentrations below 10.0 g/dL and above 12.0 g/dL during the pre- and post-switch periods.|Month -3, -2, -1, 1, 2, 3, 4, 5 and 6|Primary analysis set||percentage of participants||95% Confidence Interval|Number
652853|NCT01997892|Secondary|Hemoglobin Concentration Rate of Change by Period|The hemoglobin rate of change is the maximum monthly increase and maximum monthly decrease for the pre- and post-switch periods. Within each period, the difference was calculated between each hemoglobin value and the most recent hemoglobin value taken at least 28 days previously. The rate of change was calculated by dividing this difference by the number of days in the interval and multiplying by 28. The maximum and minimum rate of change was then determined per participant.|Thre months prior to switch and 6 months after the switch|Primary Analysis Set with available data||g/dL/4 week||Standard Deviation|Mean
652854|NCT01997892|Secondary|Dose Ratio Measured at the Time of Switch From PEG Epoetin Beta to Darbepoetin Alfa|Dose ratio is the average weekly dose of the first darbepoetin alfa dose divided by the average weekly dose of peg-epoetin beta at switch (μg darbepoetin alfa per 1 μg pegylated-epoetin beta).|Week -1 and Week 1|Primary analysis set||ratio||95% Confidence Interval|Geometric Mean
652855|NCT01997892|Secondary|Darbepoetin Alfa Dose From the Switch Date Until the End of the Observation Period|Mean weekly doses were calculated per participant by first calculating a mean daily dose for the interval (by dividing each dose evenly between the days bounded by its date of administration and the day before the next dose, then taking a mean of these partial doses for the days in the interval) and multiplying by 7 to convert to a weekly dose. Weekly doses >150 μg have been excluded as they were deemed infeasible values derived by the algorithm.|Month 1, 2, 3, 4, 5 and 6|"Primary analysis set; participants with available data at each time point (as indicated by n)."||μg/week||95% Confidence Interval|Geometric Mean
652856|NCT01997892|Secondary|PEG Epoetin Beta Dose From the Start of the Observation Period Until the Switch|Mean weekly doses were calculated per participant by first calculating a mean daily dose for the interval (by dividing each dose evenly between the days bounded by its date of administration and the day before the next dose, then taking a mean of these partial doses for the days in the interval) and multiplying by 7 to convert to a weekly dose. Weekly doses >150 μg have been excluded as they were deemed infeasible values derived by the algorithm.|Month -3, Month -2, Month -1|"Primary analysis set; participants with available data at each time point (indicated by n)."||μg/week||95% Confidence Interval|Geometric Mean
652857|NCT01997892|Primary|Hemoglobin Concentration at Monthly Intervals|Hemoglobin concentration from 3 months prior to switch to darbepoetin alfa until the end of the observation period.|Month -3, -2, -1 (pre-switch), and Month 1, 2, 3, 4, 5 and 6 (post-switch)|"Primary analysis set; participants with available data at each time point (indicated by n)."||g/dL||Standard Deviation|Mean
652858|NCT01997723|Other Pre-specified|Percentage of Participants Who Prefer Home Testing Over Laboratory Testing|Participants indicated which test (PM or PSG) they preferred.|1 week|||percentage of participants|||Number
652860|NCT01997723|Primary|Apnea Hypopnea Index (AHI)|"AHI is the number of abnormal respiratory events (apneas and hypopneas) per hour of sleep.
AHI on home portable monitor (PM) compared to AHI on laboratory polysomnography (PSG)."|4 days|The polysomnography area under the curve (AUC) in an ROC plot for this study was assumed to be 0.99. The AUC for home PM test was targeted at 0.88 based on published report for power of 0.90 in a population with estimated pretest probability of 75-85%, ascertained by Berlin Questionnaire.||events per hour||Standard Deviation|Mean
652861|NCT01997567|Secondary|Veterans RAND 12 Item Health Survey (VR-12) Scores|Preoperative VR-12 scores will be compared with the VR-12 scores obtained at the 3 mo and 6 mo postoperative visits.|6 months postoperative||||||
652862|NCT01997567|Secondary|Veterans RAND 12 Item Health Survey (VR-12) Scores|Preoperative VR-12 scores will be compared with the VR-12 scores obtained at the 3 mo and 6 mo postoperative visits.|3 months postoperative||||||
652863|NCT01997567|Secondary|Veterans Research and Development (RAND) 12 Item Health Survey (VR-12) Scores|Preoperative VR-12 scores will be compared with the VR-12 scores obtained at the 3 mo and 6 mo postoperative visits.|Preoperative 2-8 wks||||||
652864|NCT01997567|Primary|Pain Numerical Rating Scale Score (NRS 0-10)|The primary outcome measure will be pain scores at rest (NRS 0-10). Those scores will be documented at initial visit prior to surgery, and at postoperative office visits at 3 weeks, 3 months and 6 months post-procedure.|6 months postoperative||||||
652865|NCT01997567|Primary|Pain Numerical Rating Scale Score (NRS 0-10)|The primary outcome measure will be pain scores at rest (NRS 0-10). Those scores will be documented at initial visit prior to surgery, and at postoperative office visits at 3 weeks, 3 months and 6 months post-procedure.|3 months postoperative||||||
652866|NCT01997567|Primary|Pain Numerical Rating Scale Score (NRS 0-10)|The primary outcome measure will be pain scores at rest (NRS 0-10). Those scores will be documented at initial visit prior to surgery, and at postoperative office visits at 3 weeks, 3 months and 6 months post-procedure.|3 wks postoperative||||||
652867|NCT01997567|Primary|Pain Numerical Rating Scale Score (NRS 0-10)|The primary outcome measure will be pain scores at rest (NRS 0-10). Those scores will be documented at initial visit prior to surgery, and at postoperative office visits at 3 weeks, 3 months and 6 months post-procedure.|Preoperative 2-8 wks||||||
652868|NCT01997437|Primary|Number of Mononuclear Cells (MNCs) Per ml|MNCs were isolated from bone marrow fom each patient, and were counted by flow cytometry method. MNC were used for seeding on scaffold.|1 time before seeding on scaffold|||MNCs per ml||Standard Error|Mean
652869|NCT01997437|Secondary|Number of Disease Free Survival Patients|The disease free survival of patient were evaluated after transplantation of stem-cell seeded bioartificial trachea during 12 months post operative follow up.|12 months post operative follow up|||participants|||Number
652870|NCT01997437|Secondary|Number of Survival Patients|To evaluate the survival of patient after transplantation of stem-cell seeded bioartificial trachea during 12 months post operative follow up.|12 months post operative follow up|||participants|||Number
652871|NCT01997437|Primary|Safety of Stem-cell Seeded Bioartificial Tracheal Scaffold|Safety of the tissue engineered trachea measured by occurrence of adverse events throughout 12 months post operative follow up|12 months post operative follow up|||participants|||Number
652872|NCT01997411|Secondary|Time to Achieving ≥25 mg/dl Rise in Plasma Glucose Above Basal Level|Time (in minutes) when all participants experienced a rise in glucose >=25mg/dL. This is an absolute number and is not a calculated statistic. There is no distribution per cohort.|0 to 90 minutes following glucagon administration|One participant in the 4 to <8 year old 2.0 mg Intranasal Glucagon group was excluded since the participant did not receive glucagon due to blowing nose after IN administration. One participant in the 8 to <12 group withdrew after completion of the 3.0 mg Intranasal Glucagon visit and did not complete the 2.0 mg Intranasal Glucagon visit.||minutes|||Number
652873|NCT01997411|Secondary|The Proportion and 99% Confidence Interval of Participants Achieving at Least a 25 mg/dl Rise in Blood Glucose Above Basal Level||0 to 90 minutes following glucagon administration|One participant in the 4 to <8 year old 2.0 mg Intranasal Glucagon group was excluded since the participant did not receive glucagon due to blowing nose after IN administration. One participant in the 8 to <12 group withdrew after completion of the 3.0 mg Intranasal Glucagon visit and did not complete the 2.0 mg Intranasal Glucagon visit.||proportion of participants||99% Confidence Interval|Number
652874|NCT01997411|Secondary|Area Under the Effect Concentration Time Curve (AUEC0-1.5) of Glucose From Time Zero up to 90 Minutes||0 to 90 minutes following glucagon administration|One participant in the 4 to <8 year old 2.0 mg Intranasal Glucagon group was excluded since the participant did not receive glucagon due to blowing nose after IN administration. One participant in the 8 to <12 group withdrew after completion of the 3.0 mg Intranasal Glucagon visit and did not complete the 2.0 mg Intranasal Glucagon visit.||hr*mg/dL||Standard Deviation|Mean
652875|NCT01997411|Secondary|Time to Maximum Concentration (Tmax) of Glucose||0 to 90 minutes following glucagon administration|One participant in the 4 to <8 year old 2.0 mg Intranasal Glucagon group was excluded since the participant did not receive glucagon due to blowing nose after IN administration. One participant in the 8 to <12 group withdrew after completion of the 3.0 mg Intranasal Glucagon visit and did not complete the 2.0 mg Intranasal Glucagon visit.||hours||Full Range|Median
652876|NCT01997411|Secondary|Maximum Concentration (Cmax) of Glucose||0 to 90 minutes following glucagon administration|One participant in the 4 to <8 year old 2.0 mg Intranasal Glucagon group was excluded since the participant did not receive glucagon due to blowing nose after IN administration. One participant in the 8 to <12 group withdrew after completion of the 3.0 mg Intranasal Glucagon visit and did not complete the 2.0 mg Intranasal Glucagon visit.||mg/dL||Standard Deviation|Mean
652877|NCT01997411|Secondary|Nasal and Non-nasal Effects/Symptoms|"Symptoms of runny nose, nasal congestion and/or itching, sneezing, watery and/or itchy eyes, redness of eyes, and itching of ears and/or throat were assessed prior to administering glucagon and at 15, 30, 60 and 90 minutes following administration of glucagon. This is done via the Nasal Non-nasal Score Questionnaire. Each of the 9 symptoms is assigned an integer value from 0 to 3; higher values indicate more severe symptoms (a score of 0 indicates no symptoms). The reported results indicate the cohort median out of a possible maximum value of 27 (summing all 9 questions for each subject and reporting the median/IQR across participants)."|Timepoints of 15 minutes, 30 minutes, 60 minutes, and 90 minutes post glucagon administration|One participant in the 8 to <12 group withdrew from the study after completion of the 3.0 mg Intranasal Glucagon visit and did not complete the 2.0 mg Intranasal Glucagon visit.||units on a scale||Inter-Quartile Range|Median
652878|NCT01997411|Secondary|Area Under the Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t) of Glucagon||0 to 90 minutes following administration of glucagon|One participant in the 4 to <8 year old 2.0 mg Intranasal Glucagon group was excluded since the participant did not receive glucagon due to blowing nose after IN administration. One participant in the 8 to <12 group withdrew after completion of the 3.0 mg Intranasal Glucagon visit and did not complete the 2.0 mg Intranasal Glucagon visit.||hr*pg/mL||Standard Deviation|Mean
652879|NCT01997411|Primary|Time to Maximum Concentration (Tmax) of Glucagon||0 to 90 minutes following glucagon administration|One participant in the 4 to <8 year old 2.0 mg Intranasal Glucagon group was excluded since the participant did not receive glucagon due to blowing nose after IN administration. One participant in the 8 to <12 group withdrew after completion of the 3.0 mg Intranasal Glucagon visit and did not complete the 2.0 mg Intranasal Glucagon visit.||mins||Inter-Quartile Range|Mean
652880|NCT01997411|Primary|Maximum Observed Concentration (Cmax) of Glucagon||0 to 90 minutes following glucagon administration|One participant in the 4 to <8 year old 2.0 mg Intranasal Glucagon group was excluded since the participant did not receive glucagon due to blowing nose after IN administration. One participant in the 8 to <12 group withdrew after completion of the 3.0 mg Intranasal Glucagon visit and did not complete the 2.0 mg Intranasal Glucagon visit.||pg/mL||Standard Deviation|Mean
652881|NCT01997411|Primary|Percentage of Participants With >= 25 mg/dL Rise in Plasma Glucose||0 to 20 minutes following administration of glucagon|One participant in the 4 to <8 year old 2.0 mg Intranasal Glucagon group was excluded since the participant did not receive glucagon due to blowing nose after IN administration. One participant in the 8 to <12 group withdrew after completion of the 3.0 mg Intranasal Glucagon visit and did not complete the 2.0 mg Intranasal Glucagon visit.||percentage of participants|||Number
652882|NCT01997398|Secondary|Parkinson's Disease Quality-39 Score (PDQ-39)|"Effects on PDQ-39 scores 6 months following asleep DBS surgery as compared to pre-operative scores. Data from the PDQ-39 can be presented either subset scores or as a single total score. PDQ-39 measures patient quality of life indicators including mobility, activities of daily living, emotional well being, stigma, communication and bodily discomfort. Data from the PDQ-39 can be presented in either subset scores or as a single total score. The full range of the total PDQ-39 scores is from 0 ( no patient related symptoms, or quality of life unaffected) to 156 ( relates having symptoms , or low quality of life).
The subset score ranges are as follows:
mobility: 0 (no patient related symptoms) to 40 (highest patient related symptoms). activities of daily living: 0 to 24; emotional well being: 0-24; stigma: 0-16; cognition: 0-16; communication: 0-12; bodily discomfort: 0-12."|pre-operatively and 6 months post-operatively|||units on a scale||Standard Deviation|Mean
652883|NCT01997398|Primary|"Off and On Medication Unified Parkinson's Disease Rating III Score (UPDRS)"|"A movement disorders clinician who had completed the Movement Disorder Society’s Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) training performed prospective baseline and 6-month postoperative assessments of motor function using the MDS modified UPDRS III on patients during both off-medication (PD medications held for 12 h) and on-medication states.
UPDRS III motor scores range from 0 (no motor function deficit) to 132 (highest motor function deficit). There were no subscales."|pre-operatively and 6 months post-operatively|||units on a scale||Standard Deviation|Mean
652884|NCT01997216|Secondary|Mean Monocular Over-refraction (OR) at Distance|OR is the amount of additional correction needed to improve visual acuity (VA). The OR at dispense was conducted with non-study product to determine lens power for the 9-hour wear. Dispensing of the study product (Pair 1 and Pair 2) was dependent upon lens power as determined by OR and resultant product availability. The OR at 9 hours was conducted with study product. All OR data is reported regardless whether study product was dispensed. Each eye contributed to the mean.|Up to Hour 9|All enrolled participants exposed to study product. OR data is included for the 1 participant not exposed to Delefilcon A MF due to product unavailability.||diopter||Standard Deviation|Mean
652885|NCT01997216|Secondary|Mean Binocular HC/HI Visual Acuity at Distance|The participant read a Snellen chart at a 20-foot equivalent distance with both eyes together while wearing study lenses. The Snellen acuity was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal distance eyesight. A negative logMAR value denotes better visual acuity.|Up to Hour 9|All enrolled participants exposed to study product. 1 participant was not exposed to Delefilcon A MF due to product unavailability.||logMAR||Standard Deviation|Mean
652886|NCT01997216|Primary|Mean Binocular HC/HI Visual Acuity at Near (40 cm)|The participant read a Snellen chart at 40 centimeters with both eyes together while wearing study lenses. The Snellen acuity was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal near eyesight. A negative logMAR value denotes better visual acuity.|Up to Hour 9|All enrolled participants exposed to study product. 1 participant was not exposed to Delefilcon A MF due to product unavailability.||logMAR||Standard Deviation|Mean
652887|NCT01996904|Secondary|Ultrasound Diagnosis|US is a diagnostic imaging technique used to visualise deep structures of the body by recording the echoes of pulsed ultrasonic waves directed into the tissues and reflected by tissue planes to the transducer. These echoes are converted into 'pictures' of the tissues under examination. It consists of a non-invasive examination that has practically no adverse effects and allows dynamic visualisation of the tendons during movement of the shoulder.|every three months after the surgery until the 24th month||||||
652888|NCT01996904|Primary|ASES Score|The ASES is a 100-point scale which is divided in two sections. Fifty points of which are derived from patient self-report of pain and the other 50 points of which are computed from a formula using the cumulative score of 10 activities of daily living .The item related to pain is evaluated by a VAS (10 cm) that ranges from 0 (no pain at all) to 10 (pain as bad as it can be). The ten activities of daily living include skills such as putting on a coat, sleeping on the affected side, wash back/do up bra in back, manage toileting, combing one's hair, reach a high shelf, lift 10lbs above shoulder,throw a ball overhand,do usual work and do usual sport.The items related to function are evaluated by a four-point Likert scale. The scores of the pain and function subsections are transformed in percentages and each one represents 50% of the final score, which can range from 0 (absence of function) to 100 (normal function).|24th month|||units on a scale||Standard Deviation|Mean
652889|NCT01996813|Secondary|Length of Cerebral Desaturation Event|The length of time of each cerebral desaturation event (CDE) will be recorded for each occurrence.|will be assessed intraoperatively|||seconds|||Number
652890|NCT01996813|Primary|Incidence of Intraoperative Cerebral Desaturation Event|The primary outcome measure will be to determine if the application of compression hose on the legs of obese patients will have an impact on the incidence of cerebral desaturation events during shoulder arthroscopy in the beach chair position.|will be assessed intraoperatively|||participants|||Number
652891|NCT01996748|Secondary|Change in Mean Global Scores of Otoscopic Signs (Erythema, Edema and Scaling) at the End of Follow-up (Day 15) Compared to Baseline (Day 1).|"Analysis of the change on global scores of otoscopic signs at the end of treatment (mean global scores of otoscopic signs on day 15 compared to baseline).
Erythema, edema and scaling were assessed on a 4 point ordinal scale; 0=absent, 1=mild, 2=moderate, 3=severe."|Baseline and day 15|||units on a scale||Standard Deviation|Mean
652892|NCT01996748|Secondary|Change in Mean Global Scores of Otoscopic Signs (Erythema, Edema and Scaling) at the End of Treatment (Day 8) Compared to Baseline (Day 1).|"Analysis of the change on global scores of otoscopic signs at the end of treatment (mean global scores of otoscopic signs on day 8 compared to baseline).
Erythema, edema and scaling were assessed on a 4 point ordinal scale; 0=absent, 1=mild, 2=moderate, 3=severe."|Baseline and day 8|||units on a scale||Standard Deviation|Mean
652893|NCT01996748|Secondary|Change in Signs/ Symptoms|- Change in itching at follow-up (mean itching on days 9-15 compared to baseline).|Baseline and days 9-15|||units on a scale||Standard Deviation|Mean
652894|NCT01996748|Primary|Analysis of the Itching Change at the End of Treatment.|The analysis of the itching change at the end of treatment (mean itching on days 4-8 compared to baseline). Itching was assessed on a 4 point ordinal scale; 0=absent, 1=mild, 2=moderate, 3=severe|Baseline and days 4-8|||units on a scale||Standard Deviation|Mean
652895|NCT01996709|Secondary|Mean Frequency Score for Symptoms of Dryness at Day 90|"As reported and interpreted by the subject on a questionnaire. The subject was asked During a typical day in the past 2 weeks, how often did your eyes feel dry? and responded on a 5-point scale ((0 = Never; 1 = Rarely; 2 = Sometimes; 3 = Frequently; 4 = Constantly)."|Day 90|"This analysis group includes all subjects exposed to a study regimen with post baseline efficacy assessments. No imputation methods were employed; therefore only efficacy measurements available at each visit and time point were analyzed. Here, n is subjects with non-missing values at the specific time point for each arm group, respectively."||units on a scale||Standard Deviation|Mean
652896|NCT01996709|Secondary|Mean Frequency Score for Symptoms of Grittiness at Day 90|"As interpreted and reported by the subject on a questionnaire. The subject was asked, During a typical day in the past 2 weeks, how often did your eyes feel gritty and/or scratchy while wearing your contact lenses? and responded on a 5-point scale (1 = Never; 2 = Rarely; 3 = Sometimes; 4 = Frequently; 5 = Constantly)."|Day 90|This analysis group includes all subjects exposed to a study regimen with post baseline efficacy assessments. No imputation methods were employed; therefore only efficacy measurements available at each visit and time point were analyzed.||units on a scale||Standard Deviation|Mean
652897|NCT01996709|Secondary|"Top 2 Box Percentage Agreement for My Lenses Feel Like New at Day 90"|As interpreted and reported by the subject on a questionnaire. A 5-point Likert scale was used, where 1=strongly disagree; 2=disagree; 3=undecided; 4=agree; 5=strongly agree. The Top-2-box response (agree, strongly agree) was calculated and reported as a percentage of all responses.|Day 90|This analysis group includes all subjects exposed to a study regimen with post baseline efficacy assessments. No imputation methods were employed; therefore only efficacy measurements available at each visit and time point were analyzed.||percentage of subjects|||Number
652898|NCT01996709|Primary|Mean Change From Baseline in Investigator Rated Lid Papillae Maximum Score at Day 90|Lid papillae (bumps on the inner eyelid) were assessed by the investigator using slit-lamp biomicroscopy and classified independently for the four palpebral zones (upper lid=1-3; lower lid=4) on a 5-point forced choice scale, where 0 = None; 1 = Slight (diffuse papillae); 2 = Mild (diffuse & tufts papillae); 3 = Moderate (moderate & tufts papillae); 4 = Severe (giant papillae). The maximum of the four zones was selected for the analysis. Both eyes were included in the model for analysis. A higher change value indicates a larger reduction in the severity of the lid papillae.|Baseline (Day 0), Day 90|"This analysis group includes all subjects exposed to a study regimen with post baseline efficacy assessments. No imputation methods were employed; therefore only efficacy measurements available at each visit and time point were analyzed. Here, n is subjects with non-missing values at the specific time point for each arm group, respectively."||units on a scale||Standard Deviation|Mean
652899|NCT01996657|Secondary|All Cause Deaths|The deaths from all causes|Up to 24 months|||Participants|||Count of Participants
652900|NCT01996657|Primary|Thrombotic Events|The thrombotic events included valve thrombosis, transient ischemic attack, ischemic stroke, peripheral embolism, and myocardial infarction.|24 months|||Participants|||Count of Participants
652901|NCT01996657|Primary|Bleeding Events;|The bleeding events included cerebral hemorrhage, gastrointestinal bleeding and other major internal or external bleeding that causes death, hospitalization, or permanent injury (e.g. vision loss) or necessitates transfusion.|Up to 24 months|||Participants|||Count of Participants
652902|NCT01996410|Primary|MDASI Score of Chemotherapy-associated Symptoms With Acupuncture Treatment|"The investigators will first plot M.D. Anderson Symptom Inventory Core Items (MDASI) scores over time for the acupuncture and control groups to visually inspect for differences between the two groups. The investigators will further evaluate the difference in MDASI scores for the two groups using linear mixed models that account for multiple measurements within a single patient. A mixed model is preferable to a repeated measures ANOVA in this case, as it allows for missing time points within a single subject without eliminating that subject from the analysis.
Additionally, the investigators are able to specify how our time points are correlated within patients rather than assuming equal correlation across time points. The MDASI is comprised of 13 separate items that are not summative; therefore, the significance level for all statistical tests will be set at 0.003 (0.05/13) to account for multiple comparisons."|15 months|Per IRB guidelines, we were not permitted to analyze the 10 patients enrolled since we did not meet completed enrollment numbers.|||||
652903|NCT01996332|Secondary|Overall Survival (OS) by Line of Treatment|Time in months from the start of study treatment to date of death due to any cause. OS was calculated as (the death date or last known alive date [if death date was unavailable] minus the date of first dose of study medication plus 1 divided by 30.44).|Baseline, every 6-8 weeks up to 3 years, or until death|ITT Population; data were analyzed in 6 cohorts, with erlotinib treatment as: 1) first line; 2) maintenance after first line; 3) second line; 4) maintenance after second line; 5) third or subsequent line; or 6) maintenance after third line||months||95% Confidence Interval|Median
652904|NCT01996332|Secondary|Percentage of Participants Achieving Clinical Benefit by Line of Treatment|Efficacy was analyzed in terms of clinical benefit, defined as the sum of the number of participants achieving complete response [CR], partial response [PR], or stable disease [SD]. Tumor response was evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.0. CR was defined as disappearance of all target and non-target lesions. PR was defined as greater than or equal to (≥)30 percent (%) decrease in sum of longest diameters of target lesions taking as reference baseline sum longest diameters associated to non-progressive disease response for non target lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference smallest sum of longest dimensions since treatment started associated to non-progressive disease response for non target lesions.|Baseline, every 6-8 weeks up to 3 years or until death|Response evaluable population: participants with measurable disease and with matching criteria to have a response assessment; data were analyzed in 6 cohorts, with erlotinib treatment as: 1) first line; 2) maintenance after first line; 3) second line; 4) maintenance after second line; 5) third or subsequent line; or 6) maintenance after third line||percentage of participants||95% Confidence Interval|Number
652905|NCT01996332|Primary|Time to Disease Progression or Death by Line of Treatment|Time to progression or death was defined as the time from inclusion to the date of disease progression or death, whichever occurred first.|Baseline, every 6-8 weeks up to 3 years until disease progression or death|ITT Population; data were analyzed in 6 cohorts, with erlotinib treatment as: 1) first line; 2) maintenance after first line; 3) second line; 4) maintenance after second line; 5) third or subsequent line; or 6) maintenance after third line||months||95% Confidence Interval|Median
652906|NCT01996319|Secondary|Trough FEV1 Comparison Between QVA149 and Placebo After 22 Days|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. The mean of 3 acceptable measurements will be calculated and reported in liters. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. From the FEV1 measurements collected on either Day 22 or 57, respectively, the appropriate baseline measurements were subtracted – so either Day 22-Day1 or Day 57-Day36|Baseline, day 22, baseline day 36, day 57|Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period||Liters||Standard Deviation|Mean
652907|NCT01996319|Secondary|Peak Forced Expiratory Volume 1 (FEV1) Comparison Between QVA149 and Placebo at Day 1|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. The mean of 3 acceptable measurements will be calculated and reported in liters. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. The FEV1 measurements collected prior to dosing on either Day 1 or 36, respectively, were subtracted from the appropriate peak measures on the same respective days|Day 1 or day 36|Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period||Liters||Standard Deviation|Mean
652908|NCT01996319|Secondary|Change From Baseline in the Trough IC Comparison Between QVA149 and Placebo|Inspiratory capacity (IC) will be measured with spirometry conducted according to internationally accepted standards. The mean of 3 acceptable measurements will be calculated and reported in liters. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. From the IC measurements collected on either Day 22 or 57, respectively, the appropriate baseline measurements were subtracted – so either Day 22-Day1 or Day 57-Day36|Baseline, day 22, baseline day 36, day 57|Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period. Only patients with baseline and day 20 post treatment initiation were included in this analysis.||Liters||Standard Deviation|Mean
652909|NCT01996319|Secondary|Change From Baseline in Peak IC Comparison Between QVA149 and Placebo on Day 1.|Inspiratory capacity (IC) will be measured with spirometry conducted according to internationally accepted standards. The mean of 3 acceptable measurements will be calculated and reported in liters. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. The IC measurements collected prior to dosing on either Day 1 or 36, respectively, were subtracted from the appropriate peak measures on the same respective days|Day 1 or day 36|Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period. Only patients with baseline and day 1 post treatment initiation were included in this analysis.||Liters||Standard Deviation|Mean
652910|NCT01996319|Secondary|Change in the Duration of at Least Moderate Activity Per Day Comparison of QVA149 Versus Placebo|Least moderate activity (defined as 3,5-7kcal/min) will be measured via Actinography device. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. From the activity measurements collected on either Day 22 or 57, respectively, the appropriate baseline measurements were subtracted – so either Day 22-Day1 or Day 57-Day36|Baseline, day 22, baseline day 36, day 57|Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period. Only patients with baseline and day 22, plus baseline day 36 and day 57 data were included in this analysis.||Minutes||Standard Deviation|Mean
652911|NCT01996319|Secondary|Change in the Comparison of QVA149 vs. Placebo on the Average Number of Steps Per Day|The average number of steps per day will be measured via Actinography device. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. From the activity measurements collected on either Day 22 or 57, respectively, the appropriate baseline measurements were subtracted – so either Day 22-Day 1 or Day 57-Day36|Baseline, day 22, baseline day 36, day 57|Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period. Only patients with baseline and day 22 data, plus baseline on day 36 and day 57 data were included in this analysis||Steps/day||Standard Deviation|Mean
652912|NCT01996319|Primary|Change From Baseline in the Comparison of QVA149 Versus Placebo With Respect to Average Physical Activity Level|Average physical activity level is defined by average daily activity-related energy consumption [Kcal/day], measured via Actinography device. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. From the activity measurements collected on either Day 22 or 57, respectively, the appropriate baseline measurements were subtracted – so either Day 22-Day1 or Day 57-Day36|Baseline, day 22, baseline day 36, day 57|Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period. Only patients with baseline and day 22 data, plus baseline on day 36 and day 57 data were included in this analysis.||kcal/day||95% Confidence Interval|Least Squares Mean
652913|NCT01996319|Primary|Change From Baseline in Peak Inspiratory Capacity (IC) Comparison Between QVA149 and Placebo|Inspiratory capacity (IC) will be measured with spirometry conducted according to internationally accepted standards. The mean of 3 acceptable measurements will be calculated and reported in liters. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. From the IC measurements collected on either Day 22 or 57, respectively, the appropriate baseline measurements were subtracted – so either Day 22-Day1 or Day 57-Day36|Baseline, day 22, baseline day 36, day 57|Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period. all patients were included in these analyses when baseline and day 22 data plus baseline day 36 and day 57 data were available.||Liters||95% Confidence Interval|Least Squares Mean
652914|NCT01995461|Other Pre-specified|Change From Baseline Pain Medication Need/Use at 6 Months||baseline (pre-1st injection) to 6 months post-1st injection||||||
652915|NCT01995461|Secondary|Change From Baseline Oswestry Disability Index at 6 Months|The 2 questions from this Index pertaining to Standing and Walking are being utilized to assess changes in duration of standing and walking in these patients. The two sections of the Oswestry Disability Index (ODI) used in the present study were those related to walking and standing (sections 4 and 6). For each section, the total possible score is 5 and overall ODI score was expressed as a percentage of the maximum possible score (10). Total score increases with worsening disability.|baseline (pre-1st injection) to 6 months post-1st injection|||points||95% Confidence Interval|Mean
652916|NCT01995461|Secondary|Change From Baseline Swiss Spinal Stenosis Score at 6 Months|The Swiss spinal stenosis score is a questionnaire composed of 18 multiple choice questions designed to give information as to how the patient's back and leg pain is affecting their ability to manage everyday life. The Swiss spinal stenosis (SSS) questionnaire consists of 12 baseline questions asked of all participants prior to injection and an additional 6 questions asked at each time point post-treatment. The initial 12 questions assess reliability and condition at baseline while the 6 post-treatment questions assess treatment satisfaction. All questions ask the patient to assess symptoms over the previous month with a total maximum score for the initial 12 questions of 53 and a total maximum score of 24 for the 6 additional questions. The final total score is expressed as a percentage of the maximum possible score. Total score increases with worsening disability.|baseline (pre-1st injection) to 6 months post-1st injection|||points||95% Confidence Interval|Mean
652917|NCT01995461|Primary|Change From Baseline Pain Score at 6 Months|change from baseline (pre-1st injection) pain score, based on a numeric pain scale of 0-10(most severe pain), at 6 months post-1st injection|baseline (pre-1st injection) to 6 months post-1st injection|||points||95% Confidence Interval|Mean
652918|NCT01995357|Primary|Degree of Leakage|"The primary endpoint was the degree of leakage under the baseplate, which was assessed using the three innermost rings of the 32-point leakage scale, corresponding to a total of 24 points (0 indicating no leakage and 24 indicating maximum leakage).
Results are given separately for subjects with colostomy and ileostomy. In the ileostomy group there were no SenSura Mio participants in the standard care group."|10 (- 2 days)|||units on a scale||Standard Deviation|Mean
652919|NCT01995136|Primary|Mean Change From Baseline in IOP (9:00 AM) at Week 4, Week 8, and Week 12|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). Data at 9:00 AM from Weeks 4, 8, and 12 were pooled. A more negative change indicates a greater amount of improvement. One eye (study eye) was subject to analysis.|Baseline (Day 0), Week 4, Week 8, Week 12|This analysis population includes all enrolled subjects minus any subjects with all missing data and/or critical protocol deviation/s.||mmHg||95% Confidence Interval|Least Squares Mean
652920|NCT01995045|Secondary|Mean Oxycodone Intake|The mean oxycodone use post surgery in milligrams(mg).|Post Surgery (Up to 24 hours)|||milligrams||Standard Deviation|Mean
652921|NCT01995045|Secondary|Mean Hydrocodone Intake|The mean hydrocodone use post surgery in milligrams(mg).|Post Surgery (Up to 24 hours)|||milligrams||Standard Deviation|Mean
652922|NCT01995045|Secondary|Mean Acetaminophen Intake|The mean acetaminophen use post surgery in milligrams(mg).|Post Surgery (Up to 24 hours)|||milligrams||Standard Deviation|Mean
652923|NCT01995045|Primary|Mean Pain Score|The mean pain score assessed by the Visual Analog Pain Scale ranging from 0-10; 10 being the worst possible pain.|Post-Operative Day 1 (Up to 24 hours)|||units on a scale||Standard Deviation|Mean
652924|NCT01994902|Primary|Degree of Leakage|The degree of leakage is measured using a 33-point scale measuring leakage under the baseplate, where 0 points represents the best possible outcome (no leakage) and 33 points the worst possible outcome (leakage on the whole baseplate).|28 +/- 3 days|The results presented above are the intention-to-treat results that were analysed as randomised. However, the adverse events are reported as treated and as 4 subjects did not follow the randomisation order there is a slight discrepancy between the participants number in the outcome and adverse events section.||units on a scale|Participants|Standard Deviation|Mean
652925|NCT01994876|Primary|Degree of Leakage|The degree of leakage was measured with a 32-point scale developed by Coloplast A/S, where 0 point represents the best possible outcome (no leakage) and 32 represents the worst possible outcome (full leakage under baseplate)|14 days|||units on a scale|Participants|Standard Deviation|Mean
652926|NCT01994863|Primary|Leakage|The percentage of baseplates with no leakage/seeping under the baseplate was measured. Leakage/seeping under the baseplate was assessed after each baseplate change.|14+/-3 days per product|Intention-to-treat population||percentage of baseplates with no leakage|Participants||Number
652927|NCT01994785|Primary|Number of Participants Experiencing Hypoxia During Capnography Monitoring.||One day--data is collected during one endoscopic procedure.|||Participants|||Count of Participants
652928|NCT01994746|Secondary|Time to Maximum Concentration (Tmax) of Glucose||0 to 90 minutes following glucagon administration||||||
652929|NCT01994746|Secondary|Maximum Concentration (Cmax) of Glucose||0 to 90 minutes following glucagon administration||||||
652930|NCT01994746|Secondary|Area Under the Effect Concentration Time Curve (AUEC0-1.5) of Glucose From Time Zero up to 90 Minutes||0 to 90 minutes following glucagon administration||||||
652931|NCT01994746|Secondary|Time to Maximum Concentration (Tmax) of Glucagon||0 to 90 minutes following glucagon administration||||||
652932|NCT01994746|Secondary|Maximum Observed Concentration (Cmax) of Glucagon||0 to 90 minutes following glucagon administration||||||
652933|NCT01994746|Secondary|Area Under the Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t) of Glucagon||0 to 90 minutes following glucagon administration||||||
652935|NCT01994746|Secondary|Recovery From Symptoms of Hypoglycemia|Recovery from clinical symptoms of hypoglycemia if present as documented using the hypoglycemia symptoms questionnaire which is completed when the plasma glucose reaches <75 mg/dL and at 15, 30, 45 and 60 minutes following administration of glucagon.|plasma glucose <75 mg/dl to 60 minutes following administration of glucagon||||||
652936|NCT01994746|Secondary|Nasal and Non-nasal Effects/Symptoms|Symptoms of runny nose, nasal congestion and/or itching, sneezing, watery and/or itchy eyes, redness of eyes, and itching of ears and/or throat will be assessed at 15, 30, 60 and 90 minutes following administration of glucagon.|15 to 90 minutes post glucagon administration||||||
652937|NCT01994746|Primary|Increase in Plasma Glucose Level to >=70mg/dL or an Increase of >=20mg/dL|Increase in blood glucose to >=70 mg/dL or an increase of >=20 mg/dL within 30 minutes after receiving glucagon, without receiving additional actions to increase the blood glucose level such as oral or intravenous glucose or additional glucagon.|within 30 minutes after receiving glucagon|||percentage of participants|||Number
652938|NCT01994720|Secondary|Number of Participants With Premature Discontinuation of Study Drug Due to Any Bleeding Adverse Event|Participants discontinuation of study drug due to any bleeding adverse event. If no event, censoring occures at the minimum of (last date of event assessment, date of death, end of treatment date, day 97).|Time from first dose and up to and including 7 days following the date of last dose of the study|The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available.||Participants|||Number
652939|NCT01994720|Secondary|Number of Participants With PLATO Major Bleeding Event|"Participants with PLATO Major bleeding. If no event, censoring occures at the minimum of (last date of event assessment, date of death, end of treatment date, day 97).
PLATO Major bleeding is defined as a bleed that is any one of:
Fatal
Intracranial (excluding asymptomatic haemorrhagic transformations of ischemic brain infarctions and excluding micro-hemorrhages <10 mm evident only on gradient-echo MRI)
Intrapericardial bleed with cardiac tamponade
Hypovolaemic shock or severe hypotension due to bleeding and requiring pressors or surgery
Significantly disabling (eg. intraocular with permanent vision loss)
Clinically overt or apparent bleeding associated with a decrease in Hb of more than 30 g/L (1.9 mmol/L; 0.465 mmol/L)
Transfusion of 2 or more units (whole blood or packed red blood cells [PRBCs]) for bleeding."|From randomization up to 97 days|The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available.||Participants|||Number
652940|NCT01994720|Secondary|EQ-5D (EuroQol Five Dimensions Questionnaire) at Premature Treatment Discontinuation Visit|"EQ-5D index score using the UK tariff.
EQ-5D is a self assessment of 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. For each dimension responders are asked to state their status on a three level ordinal scale; whether they experience no problems (Level 1), some problems (Level 2) or severe problems (Level 3). Health states defined by the 5 dimensions can be converted into a weighted health state index (health state utility) by applying scores from the EQ-5D value sets elicited from general population samples.
The higher the index score the better the health state. In this study index scores ran from -0.59 to 1."|Premature treatment discontinuation visit(<15 days after last dose)|Include only results from patients who visit the site in-person. The Premature Treatment Discontinuation visit (PTDV) is only done for patients who prematurely and permanently stop study medication.||Index score||Standard Deviation|Mean
652941|NCT01994720|Secondary|EQ-5D (EuroQol Five Dimensions Questionnaire) at End of Treatment Visit|"EQ-5D index score using the UK tariff.
EQ-5D is a self assessment of 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. For each dimension responders are asked to state their status on a three level ordinal scale; whether they experience no problems (Level 1), some problems (Level 2) or severe problems (Level 3). Health states defined by the 5 dimensions can be converted into a weighted health state index (health state utility) by applying scores from the EQ-5D value sets elicited from general population samples.
The higher the index score the better the health state. In this study index scores ran from -0.59 to 1."|End of treatment visit (Day 90+-7d)|Include only results from patients who visit the site in-person.||Index score||Standard Deviation|Mean
652942|NCT01994720|Secondary|EQ-5D at Visit 2 (Day 7+-2d)|"EQ-5D (EuroQol five dimensions questionnaire) index score using the UK tariff.
EQ-5D is a self assessment of 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. For each dimension responders are asked to state their status on a three level ordinal scale; whether they experience no problems (Level 1), some problems (Level 2) or severe problems (Level 3). Health states defined by the 5 dimensions can be converted into a weighted health state index (health state utility) by applying scores from the EQ-5D value sets elicited from general population samples.
The higher the index score the better the health state. In this study index scores ran from -0.59 to 1."|Visit 2 (Day 7+-2d)|Include only results from patients who visit the site in-person.||Index score||Standard Deviation|Mean
652943|NCT01994720|Secondary|EQ-5D at Visit 1 (Enrolment)|"EQ-5D (EuroQol five dimensions questionnaire) index score using the UK tariff.
EQ-5D is a self assessment of 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. For each dimension responders are asked to state their status on a three level ordinal scale; whether they experience no problems (Level 1), some problems (Level 2) or severe problems (Level 3). Health states defined by the 5 dimensions can be converted into a weighted health state index (health state utility) by applying scores from the EQ-5D value sets elicited from general population samples.
The higher the index score the better the health state. In this study index scores ran from -0.59 to 1."|Visit 1 (Enrolment)|Include only results from patients who visit the site in-person.||Index score||Standard Deviation|Mean
652944|NCT01994720|Secondary|Change in NIHSS|"Change from baseline to end of treatment visit in NIHSS (National Institutes of Health Stroke Scale):
0 No stroke symptoms 1-4 Minor stroke 5-15 Moderate stroke 16-20 Moderate to severe stroke 21-42 Severe stroke."|From randomization up to 97 days|NIHSS in patients with an index stroke event||Participants|||Number
652945|NCT01994720|Secondary|Number of Participants With Disabling Stroke|Participants with disabling stroke. If no event, censoring at the minimum of (last date of event assessment, date of death, end of treatment date, day 97).|From randomization up to 97 days|The population was the full analysis set, which included all randomized patients.||Participants|||Number
653517|NCT01982435|Secondary|Loss in Vision Greater Than or Equal to 15 Letters|Number of participants that lost greater than or equal to 15 letters of vision in their study eye at months 6 and 12.|Months 6 and 12|||Participants|||Count of Participants
652946|NCT01994720|Secondary|Number of Participants With Fatal Stroke|Participants with fatal stroke. If no event, censoring at the minimum of (last date of event assessment, date of death from non-CV causes, end of treatment date, day 97).|From randomization up to 97 days|The population was the full analysis set, which included all randomized patients.||Participants|||Number
652947|NCT01994720|Secondary|Number of Participants With Stroke|Participants with stroke. If no event, censoring at the minimum of (last date of event assessment, date of death, end of treatment date, day 97)|From randomization up to 97 days|The population was the full analysis set, which included all randomized patients.||Participants|||Number
652948|NCT01994720|Secondary|Number of Participants by Severity of Stroke and Overall Disability|"Analysis of severity of stroke and overall disability of patients, using the modified Rankin Score, mRS.
Modified Rankin Score:
0 - No symptoms.
- No significant disability. Able to carry out all usual activities, despite some symptoms.
- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
- Moderate disability. Requires some help, but able to walk unassisted.
- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
- Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
- Dead.
Disability defined as mRS > 1.
Odds ratio and p-value are calculated for ticagrelor versus ASA from a logistic regression model with treatment group, history of stroke and NIHSS (National Institutes of Health Stroke Scale) at baseline as explanatory variables."|From randomization up to 97 days|The population was the full analysis set which included all randomized patients.||Participants|||Number
652949|NCT01994720|Secondary|Number of Participants With MI|Participants with MI. If no event, censoring at the minimum of (last date of event assessment, date of death, end of treatment date, day 97)|From randomization up to 97 days|The population was the full analysis set, which included all randomized patients.||Participants|||Number
652950|NCT01994720|Secondary|Number of Participants With CV Death|Participants with CV death. If no event, censoring at the minimum of (last date of event assessment, date of death from non-CV causes, end of treatment date, day 97).|From randomization up to 97 days|The population was the full analysis set, which included all randomized patients.||Participants|||Number
652951|NCT01994720|Secondary|Number of Participants With All-Cause Death|Participants with all-cause death. If no event, censoring at the minimum of (last date of event assessment, end of treatment date, day 97).|From randomization up to 97 days|The population was the full analysis set, which included all randomized patients.||Participants|||Number
652952|NCT01994720|Secondary|Number of Participants With Composite of Ischaemic Stroke, MI and CV Death|Participants with ischaemic stroke, MI or CV death. If no event, censoring at the minimum of (last date of event assessment, date of death from non-CV causes, end of treatment date, day 97).|From randomization up to 97 days|The population was the full analysis set, which included all randomized patients.||Participants|||Number
652953|NCT01994720|Secondary|Net Clinical Outcome|Participants with stroke, MI, death or life-threatening bleeding. If no event, censoring occures at the minimum of (last date of event assessment, end of treatment date, day 97).|From randomization up to 97 days|The population was the full analysis set, which included all randomized patients.||Participants|||Number
652954|NCT01994720|Secondary|Number of Participants With Ischaemic Stroke|Participants with ischaemic stroke. If no event, censoring occures at the minimum of (last date of event assessment, date of death, end of treatment date, day 97).|From randomization up to 97 days|The population was the full analysis set, which included all randomized patients.||Participants|||Number
652955|NCT01994720|Primary|Number of Participants With Composite of Stroke/MI/Death|Participants with stroke, MI or death. If no event, censoring occures at the minimum of (last date of event assessment, end of treatment date, day 97).|From randomization up to 97 days|The population was the full analysis set, which included all randomized patients.||Participants|||Number
652966|NCT01994486|Secondary|Proportion of Subjects With Viral Relapse||1/3/2014-9/8/2014|||participants|||Number
652967|NCT01994486|Primary|Safety of Telaprevir and Sofosbuvir When Dosed in Combination for 12 Weeks|The number of subjects who experienced Grade 3 anemia. Complete blood count was collected at baseline, week 2, week 4, week 8, week 12, week 18, and week 24. Incidence of moderate anemia (Grade 3) observed in the study treatment period.|1/3/2014-4/10/2014|||participants|||Number
652968|NCT01994486|Secondary|Proportion of Subjects Who Achieve Undetectable Hepatitis C Virus RNA at 12 Weeks After Completing Study Drug Regimen|Plasma HCV RNA levels were assessed using the COBAS TaqMan HCV RNA assay test (v2.0; Roche Diagnostics, Indianapolis, IN, USA; LLOQ=25 IU/mL;limit of detection =15 IU/mL)|6/16/2014-7/2/2014|||participants|||Number
652969|NCT01994486|Other Pre-specified|Number of Subjects With Sustained Virologic Response at 4 Weeks After Completion of Last Dose|Assessment of the antiviral efficacy (SVR 12) of combination treatment with telaprevir and sofosbuvir administered for 12 weeks.|4/22/2014-5/6/2014|||participants|||Number
652970|NCT01994486|Secondary|Characterize Steady State of Sofosbuvir Active SOF Metabolite, GS-331007|Sparse Pharmokinetic blood samples were collected at Week 2 and Week 10 (prior to daily dose) in patients treated with Telaprevir and Sofosbuvir.|1/17/2014-3/26/2014|||ng/mL||Standard Deviation|Geometric Mean
652971|NCT01994486|Primary|Frequency of Adverse Events Leading to Discontinuation of Both Telaprevir and Sofosbuvir Among Subjects Treated With Telaprevir and Sofosbuvir|Study drug adherence and adverse events were collected on all enrolled subjects and graded using the DAIDS scale. Any adverse events leading to discontinuation of both Telaprevir and Sofosbuvir were collected and are hereby reported.|12 weeks-January 3, 2014- April 10, 2014|Non-cirrhotic Hepatitis C Genotype 1 infected subjects, naive to previous Hepatitis C treatment||participants|||Number
653518|NCT01982435|Secondary|Gain in Vision Greater Than or Equal to 15 Letters|Number of participants that gained greater than or equal to 15 letters of vision in their study eye at months 6 and 12.|Months 6 and 12|||Participants|||Count of Participants
652972|NCT01994291|Other Pre-specified|Number of Participants With Change in Ophthalmoscopy Examination Results in Study Eye After Administration of Ranibizumab or Masked Sham Therapy at Week 8|Ophthalmoscopy ought to be performed after pupillary dilation to examine the vitreous body, optic nerve head, macular and peripheral retina. All findings, including the presence or absence of vitreous inflammation, ought to be documented. All post-dose ophthalmoscopy assessments ought to be made immediately following the administration of ranibizumab or masked sham therapy.|Week -5 to Week 16|The Safety Analysis Set was defined as all subjects who receive at least 1 dose of study medication.||participants|||Number
652973|NCT01994291|Other Pre-specified|Maximum Increase of Intraocular Pressure (IOP) From Baseline in Study Eye|IOP was measured using Goldmann applanation tonometry. To maintain consistency, it was recommended that the same examiner ought to measure IOP with the same tonometer at each visit for a given subject. Intraocular pressure ought to be measured in the study eye approximately 30 minutes after intravitreal injection or masked sham therapy (performed by unmasked study team member).|Week -5 to Week 16|The Safety Analysis Set was defined as all subjects who receive at least 1 dose of study medication.||mmHg||Standard Deviation|Mean
652974|NCT01994291|Other Pre-specified|Number of Participants With Changes in the Anterior Segment of the Study Eye at Week 12|The anterior biomicroscopy exam was done undilated in order to assess whether there was any anterior segment inflammation caused either by ranibizumab or PF-04634817.|Week -5 to Week 16|The Safety Analysis Set was defined as all subjects who receive at least 1 dose of study medication.||participants|||Number
652975|NCT01994291|Other Pre-specified|Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings|ECG parameters included PR interval, QRS interval, and corrected QT interval using Fridericia's formula (QTcF). Criteria for ECG changes meeting potential clinical concern included: PR interval greater than or equal to (>=)300 milliseconds (msec) or >=25% increase when baseline is greater than (>)200 msec and >=50% increase when baseline is less than or equal to (≤)200 msec; QRS interval >=200 msec or >=25% increase when baseline is greater than (>)200 msec and >=50% increase when baseline is less than or equal to (≤)200 msec; QT interval >=500 msec; and QTcF >=450 msec or >=30 msec increase. The number of participants with potentially clinically significant ECG findings at any visit were reported.|Week -5 to Week 16|The Safety Analysis Set was defined as all subjects who receive at least 1 dose of study medication.||participants|||Number
652976|NCT01994291|Other Pre-specified|Number of Participants With Laboratory Abnormalities|The following laboratory parameters were analyzed for abnormalities at any time point: hematology (hemoglobin, hematocrit, red blood cell count (RBC), white blood cell count (WBC) with differential, and platelet count); blood chemistry (sodium, potassium, chloride, bicarbonate, blood urea nitrogen (BUN), creatinine, albumin, calcium, total, direct and indirect bilirubin, gamma glutamyltransferase (GGT), alanine aminotransferase (ALT), aspartate aminotransferase (AST), lactic dehydrogenase (LDH), alkaline phosphatase, creatine phosphokinase (CPK), uric acid, amylase and lipase); follicle-stimulating hormone (FSH) (Weeks -5 to 0 only, for postmenopausal women who have been amenorrheic for at least 12 consecutive months prior to screening visit).|Week -5 to Week 16|The Safety Analysis Set was defined as all subjects who receive at least 1 dose of study medication.||participants|||Number
652977|NCT01994291|Other Pre-specified|Number of Participants With Potentially Clinically Important Post-Baseline Vital Signs|Number of participants who met the categorical summary of post-baseline criteria at any time point, defined as: supine pulse rate <40 beats per minute (bpm) or >120 bpm; supine systolic blood pressure (SBP) ≥30 millimeters of mercury (mmHg) change from baseline in same posture; supine diastolic BP (DBP) ≥20 mmHg change from baseline in same posture; supine SBP <90 mmHg; supine DBP <50 mmHg.|Week -5 to Week 16|The Safety Analysis Set was defined as all subjects who receive at least 1 dose of study medication.||participants|||Number
652978|NCT01994291|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Week 0 to Week 16|The Safety Analysis Set was defined as all subjects who receive at least 1 dose of study medication.||participants|||Number
652979|NCT01994291|Secondary|Plasma Concentration of PF-04634817 up to Week 12||Week 0, Week 4, Week 8, and Week 12|All subjects in the full analysis set (FAS) for whom a pharmacokinetic sample was obtained and analyzed. The FAS was defined as all subjects randomized and who had received at least one dose of randomized treatment and had at least one post-baseline measurement of BCVA.||nanogram (ng)/milliliter (mL)||Geometric Coefficient of Variation|Geometric Mean
652980|NCT01994291|Secondary|Mean Change From Baseline in Steps of Diabetic Retinopathy Step (ETDRS Severity Scale) in the Study Eye at Week 12|Stereo color fundus photographs using certified digital systems were taken by a photographer who had been pre-certified (“study certified”) by the Central Reading Center. They were evaluated by the Central Reading Center.|Baseline (Day 0) and Week 12|all subjects randomized and who had received at least one dose of randomized treatment and had at least one post-baseline measurement of BCVA.||Letters||80% Confidence Interval|Least Squares Mean
652981|NCT01994291|Secondary|Mean Change From Baseline in The Area of Fluorescein Leakage in the Study Eye at Week 12|Fluorescein Angiography (FA) using certified digital systems was taken by a photographer who had been pre-certified (“study-certified”) by the Central Reading Center. They were evaluated by the Central Reading Center.|Baseline (Day 0) and Week 12|all subjects randomized and who had received at least one dose of randomized treatment and had at least one post-baseline measurement of BCVA.||mm^2||80% Confidence Interval|Least Squares Mean
652982|NCT01994291|Secondary|Mean Change From Baseline in Central Subfield Retinal Thickness in the Study Eye at Week 12|A central reading center was used for the evaluation. A photographer or technician pre certified (“study certified”) by the Central Reading Center ought to perform all optical coherence tomography (OCT) imaging. Use of a Spectralis or Cirrus OCT was acceptable.|Baseline (Day 0) and Week 12|all subjects randomized and who had received at least one dose of randomized treatment and had at least one post-baseline measurement of BCVA.||microns||80% Confidence Interval|Least Squares Mean
652983|NCT01994291|Secondary|Proportion of Subjects Gaining 15 ETDRS Letters in BCVA From Baseline at Week 12|Refraction and visual acuity were assessed through the BCVA obtained using the retro illuminated ETDRS charts. Distance visual acuity was expressed as an ETDRS score (number of letters correctly read).|Baseline (Day 0) and Week 12|all subjects randomized and who had received at least one dose of randomized treatment and had at least one post-baseline measurement of BCVA.||proportion of participants|||Number
652984|NCT01994291|Primary|Mean Letter Change From Baseline at Week 12 in Best Corrected Visual Acuity (BCVA)|Refraction and visual acuity were assessed through the BCVA obtained using the retro illuminated early treatment diabetic retinopathy study (ETDRS) charts. Distance visual acuity was expressed as an ETDRS score (number of letters correctly read).|Baseline (Day 0) and Week 12|all subjects randomized and who had received at least one dose of randomized treatment and had at least one post-baseline measurement of BCVA.||Letters||80% Confidence Interval|Least Squares Mean
652985|NCT01993940|Secondary|Change From Baseline to the Last 2 Weeks of the Treatment Period in the Number of Spontaneous Bowel Movements With No Straining Per Week|A bowel movement and constipation assessment (BMCA) was completed by participants every day during the screening and treatment periods to record information about bowel movements (BMs) and constipation. The severity of straining with each bowel movement was assessed on the following scale: 0=no straining, 1=mild straining, 2=moderate straining, 3=severe straining, 4=very severe straining. SBMs without straining were defined as SBMs with a straining score of 0.|Baseline and the last 2 weeks of the treatment period (Weeks 11 and 12 for participants who completed 12 weeks of treatment)|Intent-to-treat population||SBMs with no straining / week||Standard Error|Least Squares Mean
652986|NCT01993940|Secondary|Change From Baseline to the Last 2 Weeks of the Treatment Period in the Number of Complete Spontaneous Bowel Movements Per Week|A bowel movement and constipation assessment (BMCA) was completed by participants every day during the screening and treatment periods to record information about bowel movements (BMs) and constipation. A complete spontaneous bowel movement (CSBM) was defined as an SBM which was accompanied by the feeling of complete evacuation.|Baseline and the last 2 weeks of the treatment period (Weeks 11 and 12 for participants who completed 12 weeks of treatment)|Intent-to-treat population||complete spontaneous BMs / week||Standard Error|Least Squares Mean
652987|NCT01993940|Secondary|Change From Baseline to Week 1 in the Number of Spontaneous Bowel Movements Per Week|A bowel movement and constipation assessment (BMCA) was completed by participants every day during the screening and treatment periods to record information about bowel movements (BMs) and constipation. An SBM was defined as a bowel movement that occurred without the use of a rescue laxative therapy during the 24 hours prior to the BM. Baseline was defined as the 14 days in the screening period prior to study drug administration.|Baseline and Week 1|Intent-to-treat population||spontaneous bowel movements / week||Standard Error|Least Squares Mean
652988|NCT01993940|Secondary|Change From Baseline to the Last 2 Weeks of the Treatment Period in the Number of Spontaneous Bowel Movements Per Week|A bowel movement and constipation assessment (BMCA) was completed by participants every day during the screening and treatment periods to record information about bowel movements (BMs) and constipation. An SBM was defined as a bowel movement that occurred without the use of a rescue laxative therapy during the 24 hours prior to the BM. Baseline was defined as the 14 days in the screening period prior to study drug administration.|Baseline and the last 2 weeks of the treatment period (Weeks 11 and 12 for participants who completed 12 weeks of treatment)|Intent-to-treat population||spontaneous bowel movements / week||Standard Error|Least Squares Mean
652989|NCT01993940|Primary|Percentage of Participants With a Spontaneous Bowel Movement (SBM) Response|"A bowel movement and constipation assessment (BMCA) was completed by participants every day during the screening and treatment periods to record information about bowel movements (BMs) and constipation. An SBM was defined as a bowel movement that occurred without the use of rescue laxative therapy during the 24 hours prior to the BM.
A responder was defined as a participant having 9 or more positive response weeks out of the 12-week Treatment Period and 3 positive response weeks out of last 4 weeks of the 12-week Treatment Period. A positive response week was defined as ≥ 3 SBMs per week and an increase from baseline of ≥ 1 SBM per week for that week. If a participant had less than 4 days of diary entries for a week, that week was treated as a “non-response” week.
Any participant with insufficient primary endpoint data (data for less than 9 out of the 12 weeks of the Treatment Period or less than 3 out of the last 4 weeks of the 12-week Treatment Period) was treated as a non-responder"|12-week treatment period|Intent-to-treat population||percentage of participants||95% Confidence Interval|Number
652990|NCT01993888|Secondary|Incidence of Adverse Events That Were Potentially Related to Thrombotic Events|Number of participants with adverse events that were potentially related to thrombic events|Up to 60-days following surgery|||participants|||Number
652991|NCT01993888|Secondary|Incidence of Adverse Events (AEs)||Up to 60-days following surgery|||participants|||Number
652992|NCT01993888|Secondary|Incidence of Re-bleeding Events From the TBS During the Study Follow-up||Up to 60-days following surgery|||participants|||Number
652993|NCT01993888|Secondary|Absolute Time to Hemostasis|The absolute time to achieve hemostasis at or after 4 minutes from randomization.|Intraoperative, an average of 4.2 minutes following randomization|Time to hemostasis (TTH), defined as the absolute time to achieve hemostasis at or after 4 minutes from randomization was evaluated as a secondary endpoint. In one subject in the SoC group, manual compression was not maintained until the 4-minute endpoint, but was released early and a suture was applied, at which point the subject was hemostatic.||minutes||Full Range|Median
652994|NCT01993888|Secondary|Hemostasis at the Target Bleeding Site (TBS) at 10-minutes Following Randomization|Proportion of subjects achieving hemostatic success at 10 minutes following randomization and no further bleeding requiring treatment prior to initiation of wound closure.|Intraoperative, 10 minutes following randomization|The proportion of subjects achieving hemostatic success at 10 minutes following randomization was evaluated as a secondary endpoint using the logistic model with treatment and site/institution included in the model.||participants with hemostatic success|||Number
652995|NCT01993888|Primary|Hemostasis at the Target Bleeding Site (TBS) at 4-minutes Following Randomization|Proportion of subjects achieving hemostasis at the TBS at 4-minutes following randomization and with no re-bleeding requiring treatment at the TBS any time prior to initiation of wound closure. Hemostasis is defined as no detectable bleeding at the TBS.|Intraoperative, 4 minutes following randomization|The primary endpoint analysis was based on the Intent to Treat (ITT) analysis set.||participants with hemostatic success|||Number
652996|NCT01993823|Other Pre-specified|Mycological Study||Day 24||||||
652997|NCT01993823|Secondary|Changes in Signs/ Symptoms|"The secondary efficacy variables include:
Proportion of subjects with signs and symptoms score of “0” at Day 15
Proportion of subjects with signs and symptoms score of “0” at Day 24
Proportion of subjects with a negative culture for fungus or presumed eradication (mycological cure) on Day 24."|2 weeks and 4 weeks|ITT||percentage of patient|||Number
652998|NCT01993823|Primary|Proportion of Subjects With a Complete Response to Treatment|"Efficacy will be assessed primarily by evaluation of the fungal culture, and the sum of signs and symptom scores (pruritus, otalgia, otorrhea and aural fullness obstruction to be scored as 0=absent; 1= mild; 2=moderate; 3=severe). The primary efficacy variable is the proportion of subjects with a negative culture for fungus, AND a signs and symptom score of 0 on Day 24.
Response to the study treatment was classed according to the following definitions:
Complete response: Negative fungal culture or presumed eradication on day 24, and sum score for signs and symptoms = 0 on day 24.
Partial response: Negative culture or presumed eradication on day 24, and sum score for signs and symptoms = 1 or 2 on day 24.
No response: Positive culture on day 24 or negative culture or presumed eradication and sum score for signs and symptoms > 2 on day 24."|Day 24|ITT||participants|||Number
652999|NCT01993238|Secondary|Pain Scores Reported at 1-day Post-Treatment|During the 1-day follow-up phone call, subjects were asked to rate the pain they were currently experiencing from the Liposonix treatment using a 0-10 pain scale (0 represents no pain and 10 represents worst pain imaginable).|1 day|Intent-to-Treat||units on a scale||Standard Deviation|Mean
653000|NCT01993238|Secondary|Safety Assessment|Adverse events will be assessed and documented throughout the study|Baseline, 1 day, 1 week||||||
653001|NCT01993238|Primary|Pain Score for Overall Treatment|Following treatment, the subject was asked to evaluate the pain level for the overall treatment using the 0-10 Visual Analog Scale (0 represents no pain and 10 represents worst imaginable pain)|Baseline|Intent to Treat||units on a scale||Standard Deviation|Mean
653002|NCT01993030|Primary|Time to Wound Healing|Healing time was recorded when complete re-epithelialization had occurred. If the wound healed in advance, visit until the wound was completely healed. If the wounds were unable to heal for more than 21±3 days, unanticipated follow-ups were added until the wound was completely healed.|Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation|||Days||Standard Deviation|Mean
653003|NCT01993030|Secondary|Number of Participants With Exudation|"Physician assessment determined presence of exudation by observing whether the gauze over the primary wound dressings was soaked by exudation:
Less than two gauze was soaked by exudation within 24h---No exudation (-);
Two to four gauze was soaked by exudation within 24h---Little exudation (+);
More than four gauze was soaked by exudation within 24h---Much exudation (++);"|Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation|||participants|||Number
653004|NCT01993030|Secondary|Pain Perceived by Patient|The amount of pain that a patient perceived was assessed using a Visual Analogue Scale (VAS 0-10), which ranges across a continuum from 0 (no pain) to 10 (worst pain).|Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation|||units on a scale||Standard Deviation|Mean
653005|NCT01993030|Secondary|Number of Participants With Inflammatory Reaction|Physician assessment determined presence of inflammatory reaction which is characterized by pain, heat, redness and swelling.|Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation|||participants|||Number
653006|NCT01993030|Secondary|Number of Participants With Growth of Granulation Tissue|Physician assessment of tissue with healthy granulation tissue defined as is granular and uneven in texture, does not bleed easily and is pink in color. Unhealthy granulation tissue is typically dark which can be indicative of poor perfusion, ischemia and/or infection.|Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation|||participants|||Number
653007|NCT01992874|Secondary|Part B: Number of Subjects Who Experienced Progressive Disease (PD)|PD as per RECIST v1.1 defined as 20% increase in sum of diameters of target lesions; the appearance of >=1 new lesions.|Screening to Day 1 of each cycle (21 day in each cycle) until disease progression, intolerable toxicity, withdrawal of consent or death; assessed up to 14 Months|Safety analysis set included all subjects who received at least one dose of IMP.||subjects|||Number
653008|NCT01992874|Secondary|Part B: Number of Subjects Who Experienced Stable Disease (SD)|SD as per RECIST v1.1 defined as neither shrinkage to qualify for PR nor increase to qualify for progressive disease (PD) taking the smallest sum diameters on study as reference. PR = 30% decrease in sum of diameters of target lesions taking as reference the baseline sum diameters; PD = 20% increase in sum of diameters of target lesions; the appearance of >=1 new lesions.|Screening to Day 1 of each cycle (21 day in each cycle) until disease progression, intolerable toxicity, withdrawal of consent or death; assessed up to 14 Months|Safety analysis set included all subjects who received at least one dose of IMP.||subjects|||Number
653009|NCT01992874|Secondary|Part B: Number of Subjects Who Experienced Partial Response (PR)|PR as per RECIST v1.1 defined as 30% decrease in sum of diameters of target lesions taking as reference the baseline sum diameters.|Screening to Day 1 of each cycle (21 day in each cycle) until disease progression, intolerable toxicity, withdrawal of consent or death; assessed up to 14 Months|Safety analysis set included all subjects who received at least one dose of IMP.||subjects|||Number
653010|NCT01992874|Secondary|Part B: Number of Subjects Who Experienced Complete Response (CR)|CR as per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 defined as disappearance of all target lesions except lymph nodes (LN); LN must have a decrease in the short axis to less than (<)10 millimeter (mm).|Screening to Day 1 of each cycle (21 day in each cycle) until disease progression, intolerable toxicity, withdrawal of consent or death; assessed up to 14 Months|Safety analysis set included all subjects who received at least one dose of IMP.||subjects|||Number
653011|NCT01992874|Secondary|Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Discontinuation|An AE was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug administration until 30 days after the last dose of study drug administration that were absent before treatment or that worsened relative to pre treatment state.|From the first dose of study drug administration until 30 days after the last dose of study drug administration, assessed up to 14 Months|Safety analysis set included all subjects who received at least one dose of IMP.||subjects|||Number
653012|NCT01992874|Primary|Area Under the Plasma Concentration-time Curve From Zero to the Last Quantifiable Concentration (AUC 0-t)|Area under the plasma concentration-time curve from time zero to the last sampling time (AUC0-t) at which the concentration was at or above the lower limit of quantification.|Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 8, and 24 hours post-dose on Day 1 and 3|PK analysis set included all subjects who received the Part A IMP, had compliance with IMP intake in Part A, at least one post-treatment PK sample from each treatment period and absence of protocol deviations affecting bioavailability.||hour*nanogram per milliliter (h*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
653013|NCT01992874|Secondary|Terminal Rate Constant (λz)||Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 8, and 24 hours post-dose on Day 1 and 3|PK analysis set included all subjects who received the Part A IMP, had compliance with IMP intake in Part A, at least one post-treatment PK sample from each treatment period and absence of protocol deviations affecting bioavailability. Here N (number of participants analyzed) signifies the number of subjects analysed for this outcome measure.||1/h||Full Range|Median
653014|NCT01992874|Secondary|Apparent Volume of Distribution (Vz/f)|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 8, and 24 hours post-dose on Day 1 and 3|PK analysis set included all subjects who received the Part A IMP, had compliance with IMP intake in Part A, at least one post-treatment PK sample from each treatment period and absence of protocol deviations affecting bioavailability. Here N (number of participants analyzed) signifies the number of subjects analysed for this outcome measure.||Liter||Geometric Coefficient of Variation|Geometric Mean
653015|NCT01992874|Secondary|Apparent Total Body Clearance (CL/f)|Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 8, and 24 hours post-dose on Day 1 and 3|PK analysis set included all subjects who received the Part A IMP, had compliance with IMP intake in Part A, at least one post-treatment PK sample from each treatment period and absence of protocol deviations affecting bioavailability. Here N (number of participants analyzed) signifies the number of subjects analysed for this outcome measure.||liter per hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
653016|NCT01992874|Secondary|Apparent Terminal Half-life (t1/2)||Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 8, and 24 hours post-dose on Day 1 and 3|PK analysis set included all subjects who received the Part A IMP, had compliance with IMP intake in Part A, at least one post-treatment PK sample from each treatment period and absence of protocol deviations affecting bioavailability. Here N (number of participants analyzed) signifies the number of subjects analysed for this outcome measure.||hour||Full Range|Median
653017|NCT01992874|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 8, and 24 hours post-dose on Day 1 and 3|PK analysis set included all subjects who received the Part A IMP, had compliance with IMP intake in Part A, at least one post-treatment PK sample from each treatment period and absence of protocol deviations affecting bioavailability.||hour||Full Range|Median
653018|NCT01992874|Secondary|Area Under the Plasma Concentration-time Curve From Zero to Infinity (AUC0-inf)||Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 8, and 24 hours post-dose on Day 1 and 3|PK analysis set included all subjects who received the Part A IMP, had compliance with IMP intake in Part A, at least one post-treatment PK sample from each treatment period and absence of protocol deviations affecting bioavailability. Here N (number of participants analysed) signifies the number of subjects analysed for this outcome measure.||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
653019|NCT01992874|Primary|Maximum Observed Plasma Concentration (Cmax)|Maximum observed plasma concentration (Cmax) was calculated for Part A Pimasertib 60 mg Capsule and tablet.|Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 8, and 24 hours post-dose on Day 1 and 3|Pharmacokinetic (PK) analysis set included all subjects who received the Part A IMP, had compliance with IMP intake in Part A, at least one post-treatment PK sample from each treatment period and absence of protocol deviations affecting bioavailability.||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
653020|NCT01992536|Secondary|26. Number of Subjects With Unsolicited Adverse Leading to New Onset Chronic Disease (NOCD) Before Study Vaccination.|Number of subjects reporting New Onset Chronic Disease (NOCD),from the end of the primary parental study V102_03 (NCT01272180) up to Day 1 visit in V102_03E1 study, is reported. (Any NOCD AEs: NOCD V102_03 (NCT01272180) vs. NOCD- Day 1, V102_03E1)|From primary parent study completion up to Day 1 in this study.|Analysis was done on the all enrolled set population. All screened subjects who have been enrolled (ie, attended the first clinic visit and received a subject ID).||Participants|||Number
653021|NCT01992536|Secondary|25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study.|Number of subjects reporting any serious unsolicited AEs (SAEs), possibly related SAEs, medically attended AEs, unsolicited AEs leading to withdrawal and deaths after receiving a booster dose of MenABCWY vaccine or placebo, are reported for the entire study period.|Day 1 to Day 365|Analysis was done on the Unsolicited Safety Set. All subjects in the exposed population who provided information about post-vaccination AEs or safety records at Day 30.||Participants|||Number
653022|NCT01992536|Secondary|24. Number of Subjects With Unsolicited (Any AEs and Possibly Related AEs) Following Booster Vaccination in This Study.|"Number of subjects reporting unsolicited AEs (any AEs and at least possibly related AEs) after receiving a booster dose of MenABCWY vaccine or placebo from Day 1 to Day 30.
Analysis was done on the Unsolicited Safety Set. All subjects in the exposed population who provided information about post-vaccination AEs or safety records at Day 30."|Day 1 through Day 30|Analysis was done on the Unsolicited Safety Set. All subjects in the exposed population who provided information about post-vaccination AEs or safety records at Day 30.||Participants|||Number
653034|NCT01992536|Secondary|12. Percentage of Subjects With Seroresponse to N. Meningitidis Serogroups A, C, W and Y, at Day 30 After Booster Vaccination in This Study.|Percentage of subjects with seroresponse to N. meningitidis serogroup A, C, W and Y, at Day 30 after the administration of a booster dose of MenABCWY vaccine or placebo in this study, versus baseline.|Day 30|Analysis was done on FAS Day 30 (Booster) population. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 30 (for seroresponse, Day 1 and Day 30 samples were required).||Percentages of Subjects||95% Confidence Interval|Number
653023|NCT01992536|Secondary|23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study.|Number of subjects reporting solicited local and systemic adverse events after receiving a booster dose of MenABCWY vaccine or placebo. the below reported events are Erythema- Injection site erythema, Induration- Injection site induration, Pain-injection site pain, Arthralgia, Chills, Fatigue, Headache, Loss of Appetite, Myalgia, Nausea, Rash, Fever, Prevention- Prevention of Pain and/or Fever, Treatment- Treatment of Pain and/or Fever and Analgesic/Antipyr.: use of Analgesic/Antipyretics in pain and fever.|From day 1 (6 hours) through day 7 after any vaccination|Analysis was done on the Solicited Safety Set, i.e. all exposed subjects who provide post vaccination solicited adverse event data.||Participants|||Number
653024|NCT01992536|Secondary|22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination.|Percentage of subjects with HT-hSBA titer ≥ 1:8 to N. meningitidis serogroups A,C,W,Y at Day 1, Day 30 (one month) and Day 365 (12 months) after the administration of MenABCWY booster vaccination in this study.|Day 1, Day 30 and Day 365|Analysis was done on FAS Day 365 (Persistence of Booster). All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 365.||Percentages of Subjects||95% Confidence Interval|Number
653025|NCT01992536|Secondary|21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B.|The HT-hSBA GMTs against Neisseria meningitidis strains of serogroups B at Day 1, Day 30 (one month) and Day 365 (12 months) after the administration of MenABCWY booster vaccination.|Day 1, Day 30 and Day 365|Analysis was done on FAS Day 365 (Persistence of Booster). All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 365.||Titers||95% Confidence Interval|Geometric Mean
653026|NCT01992536|Secondary|20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B.|The HT-hSBA GMTs against Neisseria meningitidis serogroup A, C, W, Y and strains of serogroups B at Day 1, Day 30 (one month) and Day 365 (12 months) after the administration of MenABCWY booster vaccination.|Day 1, Day 30 and Day 365|Analysis was done on FAS Day 365 (Persistence of Booster). All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 365.||Titers||95% Confidence Interval|Geometric Mean
653027|NCT01992536|Secondary|19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B.|Percentage of subjects with HT-hSBA titer ≥ 1:5 against N. meningitides strains of serogroups B at Day 1, Day 30 (one month) and Day 365 (12 months) after the administration of MenABCWY booster vaccination.|Day 1, Day 30 and Day 365|Analysis was done on FAS Day 365 (Persistence of Booster). All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 365.||Percentages of Subjects||95% Confidence Interval|Number
653028|NCT01992536|Secondary|18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y.|Percentage of subjects with HT-hSBA titer ≥ 1:8 against N. meningitidis serogroups A, C, W, Y at Day 1, Day 30 (one month) and Day 365 (12 months) after the administration of MenABCWY booster vaccination.|Day 1, Day 30 and Day 365|Analysis was done on FAS Day 365 (Persistence of Booster). All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 365.||Percentages of Subjects||95% Confidence Interval|Number
653029|NCT01992536|Secondary|17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B.|The HT-hSBA GMTs against N. meningitidis strains of serogroups B, at 24 and 36 months after the primary vaccination.|Day 1 and Day 365|Analysis was done on FAS Day 365 (Persistence of Booster) population. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 365.||Titers||95% Confidence Interval|Geometric Mean
653030|NCT01992536|Secondary|16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y.|The HT-hSBA GMTs against N. meningitidis serogroup A, C, W, Y, at 24 and 36 months after the primary vaccination.|Day 1 and Day 365|Analysis was done on FAS Day 365 (Persistence of Booster). All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 365.||Titers||95% Confidence Interval|Geometric Mean
653031|NCT01992536|Secondary|15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains.|"Percentage of subjects with four-fold rise in HT-hSBA titers against N. meningitidis serogroup B strains, at 24 and 36 months after the primary vaccination.
Four-fold rise is defined as follows: for subjects with a pre-vaccination titer < 1:2, a post-titer of ≥ 1:8; for subjects with a pre-vaccination titer ≥ 1:2 at least a four-fold increase."|Day 1, Day 30 and Day 365|Analysis was done on FAS Day 365 (Persistence of Booster). All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 365.||Percentages of Subjects||95% Confidence Interval|Number
653032|NCT01992536|Secondary|14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B|Percentage of subjects with HT-hSBA titer ≥ 1:5 against N. meningitidis strains of serogroup B, at 24 and 36 months after the primary vaccination.|Day 1, Day 30 and Day 365|Analysis was done on FAS Day 365 (Persistence of Booster) population. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 365.||Percentages of Subjects||95% Confidence Interval|Number
653033|NCT01992536|Secondary|13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y.|Percentage of subjects with HT-hSBA titer ≥ 1:8 against N. meningitidis serogroups A, C, W, Y, at 24 and 36 months after the primary vaccination.|Day 1 and Day 365|Analysis was done on the FAS Day 365 (Persistence of Booster) population. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 365.||Percentages of Subjects||95% Confidence Interval|Number
653114|NCT01990794|Secondary|Changes in Cardiac Function (LA Volume Index)|Two-dimensional and Doppler echocardiographic examinations were used to assess cardiac anatomy, structure, and function during the study with volunteers serving as their own baseline controls for changes during the study (i.e., week 0, ~day 45, ~day 90).|Baseline, at the study midpoint, and at the study completion|Participants that completed three months of cobalt supplementation||LA volume index (mL/m^2)||Standard Deviation|Mean
653035|NCT01992536|Secondary|11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains.|Percentage of subjects with HT-hSBA titer ≥ 1:5 to N. meningitidis serogroup B strains at Day 1 and Day 30 (one month) after the administration of a booster dose of MenABCWY vaccine or placebo in this study, versus baseline.|Day 1 and Day 30|Analysis was done on FAS Day 30 (Booster) population.. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 30 (for seroresponse, Day 1 and Day 30 samples were required).||Percentages of Subjects||95% Confidence Interval|Number
653036|NCT01992536|Secondary|10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y.|Percentage of subjects with HT-hSBA titer ≥ 1:8 to N. meningitidis serogroups A,C,W,Y at Day 1 and Day 30 (one month) after the administration of a booster dose of MenABCWY vaccine or placebo in this study, versus baseline.|Day 1 and Day 30|Analysis was done on FAS Day 30 (Booster) population.. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 30 (for seroresponse, Day 1 and Day 30 samples were required).||Percentages of Subjects||95% Confidence Interval|Number
653037|NCT01992536|Secondary|9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains.|"Percentage of subjects with four-fold rise in HT-hSBA titers against N. meningitidis serogroup B strains, from Day 1 (baseline) to Day 30 (one month) after the administration of MenABCWY booster vaccination or placebo.
Four-fold rise is defined as follows: for subjects with a pre-vaccination titer < 1:2, a post-titer of ≥ 1:8; for subjects with a pre-vaccination titer ≥ 1:2 at least a four-fold increase."|Day 1 and Day 30|Analysis was done on FAS Day 30 (Booster) population. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 30 (for seroresponse, Day 1 and Day 30 samples were required).||Percentages of Subjects||95% Confidence Interval|Number
653038|NCT01992536|Secondary|8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B.|The HT-hSBA GMTs against N. meningitidis strains of serogroups B at Day 1 and Day 30 (one month) after the administration of MenABCWY booster vaccination or placebo.|Day 1 and Day 30|Analysis was done on FAS Day 30 (Booster) population.. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 30 (for seroresponse, Day 1 and Day 30 samples were required).||Titers||95% Confidence Interval|Geometric Mean
653039|NCT01992536|Secondary|7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y.|The HT-hSBA GMTs against N. meningitidis serogroup A, C, W, Y at Day 1 and Day 30 (one month) after the administration of MenABCWY booster vaccination or placebo.|Day 1 and Day 30|Analysis was done on FAS Day 30 (Booster) population. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 30 (for seroresponse, Day 1 and Day 30 samples were required).||Titers||95% Confidence Interval|Geometric Mean
653040|NCT01992536|Secondary|6. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroup B.|"The HT-hSBA GMTs against N. meningitidis strains of serogroup B prior the administration of MenABCWY booster vaccination or placebo.
Pre vaccination is 24 months after completion of the primary vaccination series, in subjects who previously received the same vaccine formulation in study V102_03 (NCT01272180)."|Day 1 (Pre-vaccination)|Analysis was done on the FAS Day 1 (Persistence) population. All subjects in the enrolled population who provided an evaluable serum sample at Day 1.||Titers||95% Confidence Interval|Geometric Mean
653041|NCT01992536|Secondary|5. The HT-hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W,Y.|"The HT-hSBA GMTs against N. meningitidis serogroup A, C, W, Y prior the administration of MenABCWY booster vaccination or placebo.
Pre vaccination is 24 months after completion of the primary vaccination series, in subjects who previously received the same vaccine formulation in study V102_03 (NCT01272180)."|Day 1 (Pre-vaccination)|Analysis was done on FAS Day 1 (Persistence) population. All subjects in the enrolled population who provided an evaluable serum sample at Day 1.||Titers||95% Confidence Interval|Geometric Mean
653042|NCT01992536|Secondary|4. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B.|"Percentage of subjects with HT-hSBA titer ≥ 1:5 against N. meningitidis strains of serogroup B assessed prior to the administration of MenABCWY booster vaccination or placebo.
Pre vaccination is 24 months after completion of the primary vaccination series, in subjects who previously received the same vaccine formulation in study V102_03 (NCT01272180)."|Day 1 (Pre vaccination)|Analysis was done on the FAS Day 1 (Persistence) population. All subjects in the enrolled population who provided an evaluable serum sample at Day 1.||Percentages of Subjects||95% Confidence Interval|Number
653043|NCT01992536|Secondary|3. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitides Serogroups A, C, W, Y.|"Percentage of subjects with HT-hSBA titer ≥ 1:8 in serogroups A, C, W, Y against N. meningitides assessed prior to the administration of MenABCWY booster vaccination or placebo.
Pre vaccination is 24 months after completion of the primary vaccination series, in subjects who previously received the same vaccine formulation in study V102_03 (NCT01272180)."|Day 1 (Pre vaccination)|Analysis was done on FAS Day 1 (Persistence) population. All subjects in the enrolled population who provided an evaluable serum sample at Day 1.||Percentages of Subjects||95% Confidence Interval|Number
653044|NCT01992536|Primary|2. Percentage of Subjects With HT-hSBA Titers ≥ 1:5 Against Strains of N. Meningitidis Serogroups B.|Percentage of subjects reporting HT-hSBA titers ≥ 1:5 against strains of N. meningitidis serogroups B at baseline (Day 1) and one month (Day 30) following administration of a booster dose of MenABCWY, in the present study, in subjects who previously received the same MenABCWY vaccine formulation in study V102_03 (NCT01272180).|Day 1 and Day 30|Analysis was done on FAS Day 30 (Booster) population. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 30 (for seroresponse, Day 1 and Day 30 samples were required).||Percentages of Subjects||95% Confidence Interval|Number
653115|NCT01990794|Secondary|Changes in Cardiac Function (LVEF)|Two-dimensional and Doppler echocardiographic examinations were used to assess cardiac anatomy, structure, and function during the study with volunteers serving as their own baseline controls for changes during the study (i.e., week 0, ~day 45, ~day 90).|Baseline, at the study midpoint, and at the study completion|Participants that completed three months of cobalt supplementation||LVEF (2D est) (%)||Standard Deviation|Mean
664925|NCT01779167|Secondary|Survival of Subjects Treated With THRiL for WM.|Estimate overall survival of patients enrolled on THRiL for WM.|approximately 24 months per patient||||||
653045|NCT01992536|Primary|1. Percentages of Subjects With HT-hSBA (High-throughput Human Serum Bactericidal Assay) Seroresponse Against N. Meningitidis Serogroups A, C, W and Y.|Percentages of subjects having HT-hSBA seroresponse against N. meningitidis serogroups A, C, W and Y, following administration of a booster dose of MenABCWY, in the present study, in subjects who previously received the same MenABCWY vaccine formulation in study V102_03 (NCT01272180). Seroresponse to N. meningitidis serogroups A, C, W and Y is defined as: for subjects with a pre-vaccination HT-hSBA titer < 1:4, a post-vaccination hSBA titer ≥ 1:8; for subjects with a pre-vaccination hSBA titer ≥ 1:4, an increase in hSBA titer of at least four times the pre-vaccination titer.|Day 30|Analysis was done on FAS Day 30 (Booster) population.. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 30 (for seroresponse, Day 1 and Day 30 samples were required).||Percentages of Subjects||95% Confidence Interval|Number
653046|NCT01992523|Secondary|Dyspnoea and/or Symptomatic Bradycardia|Percentage of participants with Occurrence of dyspnoea and/or symptomatic bradycardia|6 months|Continuous data were expressed as mean ± standard deviation or medians (quartiles) as appropriate, and categorical data as proportions (%)||percentage of partecipants|||Number
653047|NCT01992523|Secondary|Bleeding Events|Percentage of participants with Major, minor, minimal bleeding (TIMI criteria) events|48 hours|||percentage of partecipants|||Number
653048|NCT01992523|Secondary|High Residual Platelet Reactivity|The percent of patients with a high residual platelet reactivity (PRU > 208) 1 hour after ticagrelor LD.|1 hour|Categorical data were expressed as proportions (%)||percentage of partecipants|||Number
653049|NCT01992523|Primary|Residual Platelet Reactivity|residual platelet reactivity by Platelet Reactivity Units (PRU) VerifyNow 1 hour after ticagrelor LD.|1 hour|Continuous data were expressed as mean ± standard deviation or medians (quartiles) as appropriate, and categorical data as proportions (%). A P value < .05 was considered statistically significant. All tests were two-sided.||PRU (P2Y12 reaction units)||Inter-Quartile Range|Median
653050|NCT01992185|Primary|Percent Repigmentation||90 days|||Percent Repigmentation||Standard Deviation|Mean
653051|NCT01992172|Primary|Number of Pruritus Events in Last 30 Days||30 days from baseline|||Events||Standard Deviation|Mean
653052|NCT01992107|Secondary|Number of Subjects Reporting Unsolicited AEs After One or Two Doses of Either QIVc, TIV1c or TIV2c by Overall Age Group|Safety was assessed in terms of number of subjects (Previously vaccinated and Not previously vaccinated) reporting unsolicited AEs (day 1 to 22 for Previously vaccinated and day 1 to day 50 for Not previously vaccinated subjects), serious adverse events (SAEs), medically attended AEs, AEs leading to withdrawal from the study, new onset of chronic diseases (NOCDs), and concomitant medications (day 1 to day 181 for Previously vaccinated and day 1 to day 210 for Not previously vaccinated subjects) after receiving one or two doses of either QIVc, TIV1c or TIV2c. For A/H1N1, A/H3N2 and B1 strain, the comparison is between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c.|Day 1 to 210 post vaccination|Analysis was done on unsolicited safety data set i.e. all subjects in the exposed set with unsolicited adverse event data||Subjects|||Number
653053|NCT01992107|Secondary|Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata|Safety was assessed in terms of number of subjects (Previously vaccinated and Not previously vaccinated) reporting solicited local and systemic reactions, day 1 to 7 after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c.For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison is between QIVc and TIV2c.|Day 1 to 7 after last vaccination|Analysis was done on solicited safety data set i.e. all subjects in the exposed set with solicited adverse event data||Subjects|||Number
653054|NCT01992107|Secondary|Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc or TIV2c|"Immunogenicity of QIVc to comparator TIV2c in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing seroconversion or significant increase in HI antibody titers, against influenza strain B1, three weeks after last vaccination with QIVc or TIV2c.
Superiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV2c – % seroconversion QIVc) for HI antibody does not exceed the margin of 0 points"|Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)|Analysis was done on FAS population||percentages of subjects||95% Confidence Interval|Number
653055|NCT01992107|Secondary|GMT in Subjects After Receiving One or Two Doses of Either QIVc,TIV2c Against B1 Strain|"Immunogenicity of QIVc to comparator TIV2c was assessed in terms of GMT in subjects (Previously vaccinated and Not previously vaccinated) measured by HI assay, three weeks after last vaccination with one or two doses of either QIVc or TIV2c.
Superiority was established if the upper bound of the two-sided 95% CI for the ratio of GMTs (GMT TIV2c /GMT QIVc) for HI antibody does not exceed the superiority margin of 1"|Day 1, Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)|Analysis was done on FAS population||Titers||95% Confidence Interval|Geometric Mean
653056|NCT01992107|Secondary|Percentages of Subjects Achieving Seroconversion Against B2 Strain After One or Two Doses of Either QIVc or TIV1c|"Immunogenicity of QIVc to comparator TIV1c in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing seroconversion or significant increase in HI antibody titers, against influenza strain B2, three weeks after last vaccination with QIVc or TIV1c.
Superiority criterion was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c – % seroconversion QIVc) for HI antibody does not exceed the margin of 0 points"|Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)|Analysis was done on FAS population||percentages of subjects||95% Confidence Interval|Number
653057|NCT01992107|Secondary|GMT in Subjects After Receiving One or Two Doses of Either QIVc, TIV1c Against B2 Strain|"Immunogenicity of QIVc to comparator TIV1c was assessed in terms of GMT in subjects (Previously vaccinated and Not previously vaccinated) measured by HI assay, three weeks after last vaccination with one or two doses of either QIVc or TIV1c.
Superiority was established if the upper bound of the two-sided 95% CI for the ratio of GMTs (GMT TIV1c /GMT QIVc) for HI antibody did not exceed the superiority margin of 1"|Day 1, Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)|Analysis was done on FAS population||Titers||95% Confidence Interval|Geometric Mean
653058|NCT01992107|Secondary|Geometric Mean Ratios (GMR) in Subjects After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years Age|Immunogenicity was measured in subjects (Previously vaccinated and Not previously vaccinated) as the geometric mean ratio (GMR). The ratio of postvaccination to prevaccination HI GMTs, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c .For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c The CHMP criterion for GMR in adult population is >2.5|Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)|Analysis was done on FAS immunogenicity set||Ratios||95% Confidence Interval|Geometric Mean
653059|NCT01992107|Secondary|Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years|Immunogenicity was assessed in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing HI titer ≥1:40, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c The Committee for Medicinal Products for Human Use (CHMP) criterion for an adult population was that the percentage of subjects achieving an HI titer ≥1:40 is >70%|Day 1, Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)|Analysis was done on FAS immunogenicity set||percentages of subjects||95% Confidence Interval|Number
653060|NCT01992107|Secondary|Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years|Immunogenicity was assessed in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing seroconversion or significant increase in HI antibody titers, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c Seroconversion was defined in subjects seronegative at baseline (i.e., HI titer <1:10 at Day 1) as postvaccination HI titer ≥1:40, and defined in subjects seropositive at baseline (i.e., HI titer ≥1:10 at Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer.|Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)|Analysis was done on FAS immunogenicity set||percentages of subjects||95% Confidence Interval|Number
653061|NCT01992107|Secondary|Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years|"Immunogenicity was assessed in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing HI titer ≥1:40, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c.
The CBER criterion for adult population was that the lower bound of the two-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥1:40 should meet or exceed 70%"|Day 1, Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)|Analysis was done on FAS immunogenicity set (FAS) i.e. all subjects in the enrolled set who received at least one study vaccination and provided immunogenicity data at day 22 (day 50 for not previously vaccinated subjects)||percentages of subjects||95% Confidence Interval|Number
653062|NCT01992107|Secondary|Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years|"Immunogenicity was assessed in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing seroconversion or significant increase in HI antibody titers, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c Seroconversion was defined in subjects seronegative at baseline (i.e., HI titer <1:10 at Day 1) as postvaccination HI titer ≥1:40, and defined in subjects seropositive at baseline (i.e., HI titer ≥1:10 at Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer.
The Center for Biologics Evaluation, Research, and Review (CBER) criterion for an adult population is that the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion for HI antibody should meet or exceed 40%"|Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)|Analysis was done on Full Analysis Set (FAS) immunogenicity set i.e. all subjects in the enrolled set who received ▫ Received at least one study vaccination and provided immunogenicity data at day 1 and day 22 (day 50 for not previously vaccinated subjects)||percentages of subjects||95% Confidence Interval|Number
653063|NCT01992107|Primary|Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c|Immunogenicity of QIVc to comparator TIVc (For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c) was assessed in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing seroconversion or significant increase (at least a 4-fold increase in HI titer in subjects seropositive at baseline [i.e., HI titer ≥1:10 at Day 1] ) in HI antibody titers, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c Seroconversion was defined in subjects seronegative at baseline (i.e., HI titer <1:10 at Day 1) as postvaccination HI titer ≥1:40, and defined in subjects seropositive at baseline (i.e., HI titer ≥1:10 at Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer.|Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)|Analysis was done on PP population||percentages of subjects||95% Confidence Interval|Number
653074|NCT01992094|Secondary|4. Percentages of Subjects Achieving HI Titer ≥1:40 After One Dose of Either QIVc, TIV1c or TIV2c in 18 to <65 and ≥ 65 Years Age-cohorts|Immunogenicity was assessed in terms of percentages of subjects showing HI titer ≥1:40, three weeks (day 22) after vaccination with either QIVc, TIV1c or TIV2c The CBER criterion for 18 to <65 years age group is that the lower bound of the two-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥ 1:40 should meet or exceed 70% and that for the ≥ 65 years age group should meet or exceed 60%|Three weeks post vaccination (Day 22)|Analysis was done on FAS immunogenicity set.||percentages of subjects||95% Confidence Interval|Number
653064|NCT01992107|Primary|Geometric Mean Titre (GMT) in Subjects After Receiving One or Two Doses of Either QIVc, TIV1c or TIV2c|"Immunogenicity of QIVc to comparator TIV1c (For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c) was assessed in terms of GMT in subjects (Previously vaccinated and Not previously vaccinated) measured by hemagglutination inhibition (HI) assay, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c.
Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV1c or TIV2c /GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5."|Day 1,Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)|Analysis was done on Per Protocol (PP) Population i.e. all subjects in the Full Analysis Set (FAS) efficacy/immunogenicity population correctly received the vaccine, had no major protocol deviations leading to exclusion as defined prior to unblinding/analysis and are not excluded due to other reasons defined prior to unblinding or analysis||Titers||95% Confidence Interval|Geometric Mean
653065|NCT01992094|Secondary|13.Number of Subjects Reporting Unsolicited Adverse Events (AEs) After One Dose of Either QIVc, TIV1c or TIV2c by Overall Age Group|Safety was assessed in terms of number (%) of subjects reporting unsolicited AEs (day 1 to 22 after vaccination), serious adverse events (SAEs), medically attended AEs, AEs leading to withdrawal from the study, new onset of chronic diseases (NOCDs), and concomitant medications (day 1 to day 181 post vaccination) after receiving one dose of either four (4) strain inactivated quadrivalent cell based influenza vaccine (QIVc) or trivalent inactivated influenza vaccine (TIV1c or TIV2c)|Day 1 to 181 post vaccination|Analysis was done on unsolicited safety data set i.e. all subjects in the exposed set with unsolicited adverse event data||Subjects|||Number
653066|NCT01992094|Secondary|12.Number of Subjects Reporting Solicited Adverse Events (AEs) After One Dose of Either QIVc, TIV1c or TIV2c by Overall Age Group|Safety was assessed in terms of number (%) of subjects reporting solicited local and systemic reactions, day 1 to 7 after vaccination with one dose of either four (4) strain inactivated quadrivalent cell based influenza vaccine (QIVc) or trivalent inactivated influenza vaccine (TIV1c or TIV2c)|Day 1 to 7 post vaccination|Analysis was done on solicited safety data set i.e. all subjects in the exposed set with solicited adverse event data||Subjects|||Number
653067|NCT01992094|Secondary|11.Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV2c Against B1 Strain|Immunogenicity of QIVc to TIV2c in terms of percentages of subjects showing seroconversion or significant increase in HI antibody titers, against influenza strain B1, three weeks (day 22) after vaccination with QIVc or TIV2c Superiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV2c – % seroconversion QIVc) for HI antibody in ≥ 18 years age group does not exceed the margin of 0 points|Three weeks post vaccination (Day 22)|Analysis was done on FAS population||percentages of subjects||95% Confidence Interval|Number
653068|NCT01992094|Secondary|10.GMT in Subjects After Receiving One Dose of Either QIVc, TIV2c Against B1 Strain|"Immunogenicity of QIVc to TIV2c was assessed by GMT in subjects measured by HI assay, three weeks after vaccination with one dose of either QIVc or TIV2c.
Superiority was established if the upper bound of the two-sided 95% CI for the ratio of GMTs (GMT TIV2c /GMT QIVc) for HI antibody does not exceed the superiority margin of 1"|Three weeks post vaccination (Day 22)|Analysis was done on FAS population||Titers||95% Confidence Interval|Geometric Mean
653069|NCT01992094|Secondary|9.Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c Against B2 Strain|Immunogenicity of QIVc to TIV1c was assessed in terms of percentages of subjects showing seroconversion or significant increase in HI antibody titers, against influenza strain B2, three weeks (day 22) after vaccination with QIVc or TIV1c Superiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c – % seroconversion QIVc) for HI antibody in ≥ 18 years age group does not exceed the margin of 0 points|Three weeks post vaccination (Day 22)|Analysis was done on FAS population||percentages of subjects||95% Confidence Interval|Number
653070|NCT01992094|Secondary|8.Geometric Mean Titres (GMT) in Subjects After Receiving One Dose of Either QIVc, TIV1c Against B2 Strain|"Immunogenicity of QIVc to TIV1c was assessed by GMT in subjects measured by HI assay, three weeks after vaccination with one dose of either QIVc or TIV1c.
Superiority was established if the upper bound of the two-sided 95% CI for the ratio of GMTs (GMT TIV1c /GMT QIVc) for HI antibody does not exceed the superiority margin of 1."|Three weeks post vaccination (Day 22)|Analysis was done on FAS population||Titers||95% Confidence Interval|Geometric Mean
653071|NCT01992094|Secondary|7. Percentages of Subjects Achieving HI Titer ≥1:40 After One Dose of Either QIVc, TIV1c or TIV2c in 18 to ≤60 Years and ≥ 61 Years Age Cohorts|Immunogenicity was assessed in terms of percentages of subjects showing HI titer ≥1:40, three weeks (day 22) after vaccination with either QIVc, TIV1c and TIV2c The CHMP criterion for 18 to ≤60 years age group is that the percentage of subjects achieving an HI titer ≥1:40 is >70% and that for ≥ 61 years age group is >60%|Three weeks post vaccination (Day 22)|Analysis was done on FAS immunogenicity set.||percentages of subjects||95% Confidence Interval|Number
653072|NCT01992094|Secondary|6. Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c or TIV2c in 18 to ≤60 Years and ≥ 61 Years Age Cohorts|Immunogenicity was assessed in terms of percentages of subjects showing seroconversion or significant increase in HI antibody titers, three weeks (day 22) after vaccination with either QIVc, TIV1c or TIV2c Seroconversion is defined in subjects seronegative at baseline (i.e., HI titer <1:10 at Day 1) as post-vaccination HI titer ≥1:40, and defined in subjects sero-positive at baseline (i.e., HI titer ≥1:10 at Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer The CHMP criterion for 18 to ≤60 years age group is that the percentage of subjects achieving seroconversion or significant increase in HI titer is >40% and that for ≥ 61 years age group is >30%|Three weeks post vaccination (Day 22)|Analysis was done on FAS immunogenicity set.||percentages of subjects||95% Confidence Interval|Number
653073|NCT01992094|Secondary|5.Geometric Mean Ratios (GMR) in Subjects After One Dose of Either QIVc, TIV1c or TIV2c in 18 to ≤60 Years and ≥ 61 Years Age Cohorts|Immunogenicity was measured as the geometric mean ratio (GMR). The ratio of post-vaccination to pre-vaccination HI GMTs, three weeks (day 22) after vaccination with either QIVc, TIV1c or TIV2c Committee for Medicinal Products for Human Use (CHMP) criterion for 18 to ≤60 years age group is >2.5 and that for ≥ 61 years age group is >2.0|Three weeks post vaccination (Day 22)|Analysis was done on FAS immunogenicity set.||Ratio||95% Confidence Interval|Geometric Mean
653075|NCT01992094|Secondary|3. Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c or TIV2c in 18 to <65 and ≥ 65 Years Age Cohorts|Immunogenicity was assessed in terms of percentages of subjects showing seroconversion or significant increase in HI antibody titers, against each vaccine strains, three weeks (day 22) after vaccination with ether QIVc, TIV1c or TIV2c Seroconversion is defined in subjects seronegative at baseline (i.e., HI titer <1:10 at Day 1) as post-vaccination HI titer ≥1:40, and defined in subjects sero-positive at baseline (i.e., HI titer ≥1:10 at Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer.The CBER criterion for 18 to <65 years age group is that the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion for HI antibody should meet or exceed 40% and that for the ≥ 65 years age group should meet or exceed 30%|Three weeks post vaccination (Day 22)|Analysis was done on FAS immunogenicity set i.e. all subjects in the enrolled set who receive the study vaccination and provide immunogenicity data at visit 1 and visit 2||percentages of subjects||95% Confidence Interval|Number
653076|NCT01992094|Primary|2. Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c or TIV2c|Immunogenicity of QIVc to comparator TIVc (For H1N1, H3N2 and B1 strain, the comparison is between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison is between QIVc and TIV2c) was assessed in terms of percentages of subjects showing seroconversion or significant increase in HI antibody titers, three weeks (day 22) after vaccination with one dose of either QIVc,TIV1c or TIV2c Seroconversion is defined in subjects seronegative at baseline (i.e., HI titer <1:10 at Day 1) as post-vaccination HI titer ≥1:40, and defined in subjects sero-positive at baseline (i.e., HI titer ≥1:10 at Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer|Three weeks post vaccination (Day 22)|Analysis was done on PP population||percentage of subjects||95% Confidence Interval|Number
653077|NCT01992094|Primary|1.Geometric Mean Titres (GMT) in Subjects After Receiving One Dose of Either QIVc, TIV1c or TIV2c|"Immunogenicity of QIVc to comparator TIVc (For H1N1, H3N2 and B1 strain, the comparison is between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison is between QIVc and TIV2c) was assessed in terms of GMT in subjects measured by hemagglutination inhibition (HI) assay, three weeks after vaccination with one dose of either QIVc or TIV1c and TIV2c.
Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV1c or TIV2c /GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5."|Three weeks post vaccination (Day 22)|Analysis was done on Per Protocol (PP) Population i.e. all subjects in the Full Analysis Set (FAS) efficacy/immunogenicity population correctly receive the vaccine, have no major protocol deviations leading to exclusion as defined prior to unblinding/analysis and are not excluded due to other reasons defined prior to unblinding or analysis||Titer||95% Confidence Interval|Geometric Mean
653078|NCT01991990|Primary|Absolute Median Fluorescence Intensities of Neutrophil Adhesion Molecules|Neutrophil surface receptor expression may be used to characterize the activation status of neutrophils. Fresh (0 min), PBS control (30 min) and fMLP-stimulated (30 min) PMNs (5 × 10^6 PMNs/mL) were fixed with CellFIX, and 90 μL transferred to each tube containing antibody mixture (2 μL cluster of differentiation [CD] 11b-brilliant violet (BV) 421, 2 μL CD16-FITC, 5 μL CD62L-allophycocyanin (APC) and 5 μL CD162-phycoerythrin [PE]) or isotype control mixture of equivalent volumes. After 30 minutes of incubation on ice and in the dark, cold PBS was added to stop further reaction. Surface marker expressions were quantified by flow cytometry.|Day 4|Safety analysis population||median fluoresence intensity||Standard Error|Mean
653079|NCT01991990|Primary|Neutrophil Morphology: Change From Baseline to the Nadir (Day 4) in the Percentage of Neutrophils With Shape Change Measured by Microscopic Morphology|Neutrophil shape change is an indicator of the chemotactic ability of neutrophils to respond to and migrate to sites of inflammation. For determination of neutrophil shape change, fresh (0 min control), PBS control (30 min control) and fMLP-stimulated (30 min fMLP) PMNs (at 5 × 10^6 PMNs/ mL) were fixed with CellFIX, 90 μL transferred to each sample tube, and cold PBS added to stop further reaction. Shape change was assessed by microscopy with neutrophils classified as shape-changed if they contained > 1 cell surface bleb or irregularity and change from baseline in percentage of neutrophil with shape change on Day 4 was reported.|Baseline, Day 4|Safety analysis population||percentage of shape changed neutrophils||Standard Error|Mean
653080|NCT01991990|Primary|Neutrophil Morphology: Change From Baseline to the Nadir (Day 4) in the Percentage of Neutrophils With Shape Change Measured by Flow Cytometry (FSC-High Cells)|Neutrophil shape change is an indicator of the chemotactic ability of neutrophils to respond to and migrate to sites of inflammation. For determination of neutrophil shape change, fresh (0 min control), PBS control (30 min control) and fMLP-stimulated (30 min fMLP) PMNs (at 5 × 10^6 PMNs/ mL) were fixed with CellFIX, 90 μL transferred to each sample tube, and cold PBS added to stop further reaction. Shape change was assessed by measuring FSC on flow cytometry. Change from baseline in the percentage of neutrophils with shape change on Day 4 was reported.|Baseline, Day 4|Safety analysis population||percentage of shape changed neutrophils||Standard Error|Mean
653081|NCT01991990|Primary|Neutrophil Morphology: Change From Baseline to Nadir in the Number of Neutrophils With Shape Change Measured Using Flow Cytometry|Neutrophil shape change is an indicator of the chemotactic ability of neutrophils to respond to and migrate to sites of inflammation. For determination of neutrophil shape change, fresh (0 min control), phosphate-buffered saline (PBS) control (30 min control) and formyl-methionyl-leucyl-phenylalanine (fMLP)-stimulated (30 min fMLP) PMNs (at 5 × 10^6 PMNs/ milliliter [mL]) were fixed with CellFIX (organic solvent used as fixative for adherent cells), 90 microliters (μL) transferred to each sample tube, and cold PBS added to stop further reaction. Shape change was assessed by measuring forward scatter (FSC) on flow cytometry. Change from baseline in the number of neutrophils with shape change on Day 4 was reported.|Baseline, Day 4|Safety analysis population||neutrophils with shape change||Standard Error|Mean
653112|NCT01990794|Secondary|Changes in Visual Function (Average C:D Ratio)|Ophthalmology studies included an assessment of visual acuity, slit lamp evaluations, and visual field testing. Retinal nerve fiber layer (RNFL) thickness and optic nerve head (ONH) were assessed using optical coherence tomography (OCT). Volunteers served as their own baseline controls for changes during the study (i.e., week 0, ~day 45, ~day 90).|Baseline, at the study midpoint, and at the study completion|Participants that completed three months of cobalt supplementation||ratio||Standard Deviation|Mean
653332|NCT01987479|Primary|Percentage of Participants With Adverse Events|An adverse event was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Adverse events included serious as well as non-serious adverse events.|Baseline up to Week 32|FAS population||percentage of participants|||Number
653082|NCT01991990|Primary|Neutrophil Survival: Change From Baseline to the Nadir in the Percentage of Apoptotic Neutrophils as Measured by Flow Cytometry|Ageing neutrophils translocate phosphatidylserine from the inner leaflet of the plasma membrane to the outer leaflet during the early stages of apoptosis. This translocation can be measured due to the affinity of Annexin V (AV) to bind exposed phosphatidylserine. Propidium Iodide (PI) is normally membrane-impermeable but enters cells in late apoptosis when their plasma membrane becomes leaky. Neutrophils constitutively undergo apoptosis when cultured ex vivo, and this can be delayed by the addition of agents such as granulocyte-macrophage colony-stimulating factor (GM-CSF) or TNFα. Apoptosis was assessed by flow cytometry with fluorescein isocyanate-labeled recombinant human AV (AV-FITC) and PI staining and the change from baseline in the percentage of apoptotic neutrophils on Day 4 measured by flow cytometry is reported.|Baseline, Day 4|Safety analysis population||percentage of apoptotic neutrophils||Standard Error|Mean
653083|NCT01991990|Primary|Neutrophil Survival: Change From Baseline to the Nadir (Day 4) in the Percentage of Apoptotic Neutrophils as Measured by Microscopic Morphology|Neutrophil apoptosis was measured using microscopy method with slides stained with Diff-Quik (modified Wright Giemsa stain) and morphology examined under oil immersion light microscopy with 100 times magnification. Neutrophils constitutively undergo apoptosis when cultured ex vivo, and this can be delayed by the addition of agents such as granulocyte-macrophage colony-stimulating factor (GM-CSF) or TNFα. Apoptotic neutrophils were characterized with dark and pyknotic nuclei compared to the viable neutrophils. Change from baseline in the percentage of apoptotic neutrophils on Day 4 measured by microscopy is reported.|Baseline, Day 4|Safety analysis population||percentage of apoptotic neutrophils||Standard Error|Mean
653084|NCT01991990|Primary|Neutrophil Respiratory Burst: Change From Baseline to Nadir (Day 4) in the Production of Reactive Oxygen Species as Measured by Chemiluminescence (Relative Light Units - Absolute)|Neutrophils generate a respiratory burst using reactive oxygen species (ROS) to kill invading pathogens. When luminol is used as a substrate for ROS, a chemical reaction is produced resulting in photon emission (chemiluminescence) in primed and unprimed neutrophils following formyl-methionyl-leucyl-phenylalanine (fMLP) stimulation which is quantifiable. fMLP stimulation of the respiratory burst is mediated through activation of nicotinamide adenine dinucleotide phosphate (NADPH) oxidase in primed neutrophils. The maximal fMLP response is observed in primed neutrophils and is an ex vivo measure of the capacity of neutrophils to respond to pathogenic stimuli. In the current experiments, neutrophils were primed with tumor necrosis factor alpha (TNFα). Light emission was recorded on a luminometer. Absolute change from baseline in the production of ROS on Day 4 was reported.|Baseline, Day 4|Safety analysis population||relative light units||Standard Error|Mean
653085|NCT01991990|Primary|Neutrophil Phagocytosis: Change From Baseline to Nadir (Day 4) in Median Fluorescence Intensity (MFI) of eFluor670+ Neutrophils|Neutrophil phagocytosis was assessed by flow cytometry using heat-killed Staphylococcal pneumonia bacteria labeled with eFluor670. Phagocytosis was quantified by measuring the eFluor670 fluorescence from neutrophils containing phagocytosed bacteria. Experiments were performed using neutrophils (PMN) only, PMN plus S. pneumonia at 4˚C (to control for non-specific bacterial adherence to PMN cell surface), and PMN plus S. pneumonia at 37˚C. Change from baseline in the eFluor670+ MFI was calculated on Day 4.|Baseline, Day 4|Safety analysis population||median fluoresence intensity||Standard Error|Mean
653086|NCT01991990|Primary|Neutrophil Phagocytosis: Change From Baseline to Nadir (Day 4) in the Percentage of eFluor670-Positive (eFluoro670+) Neutrophils|Neutrophil phagocytosis was assessed by flow cytometry using heat-killed Staphylococcal pneumonia (S.pneumonia) bacteria labeled with eFluor670. Phagocytosis was quantified by measuring the eFluor670 fluorescence from neutrophils containing phagocytosed bacteria. Experiments were performed using neutrophils (PMN) only, PMN plus S. pneumonia at 4 degrees(˚) centigrade (C) (to control for non-specific bacterial adherence to PMN cell surface), and PMN plus S. pneumonia at 37˚C. Change from baseline in the percentage of eFluor670+ neutrophils was calculated on Day 4.|Baseline, Day 4|Safety analysis population.||percentage of eFlouro+ neutrophils||Standard Error|Mean
653087|NCT01991990|Primary|Neutrophil Redistribution Analysis on Day 10|On Day 4 participants had neutrophils isolated from 100 mL of ACD-anti-coagulated autologous venous blood and labeled with up to 2.5 MBq 111In-tropolonate before being reinjected. Participants rested for 45 min post-injection to allow for neutrophil equilibrium between the circulating and marginating neutrophil pools. Whole-body profiling was performed in a heavily shielded dedicated whole-body counter with 2 highly sensitive scintillation detectors with the recorded counts corrected for the physical decay of 111In to allow measurement of the effect of TCZ on the normal redistribution pattern of neutrophils and assessment of margination of neutrophils in the presence of TCZ. Distribution of radiolabelled neutrophils and peak counts, on Day 10 (6 days post re-injection) in liver/spleen and pelvic bone marrow were decay corrected and expressed as percentages of Day 4 (45 minutes post re-injection).|Day 10|Safety analysis population. One participant in the PMN-high group was excluded due to external contamination affecting profiling data.||percentage of Day 4 counts||Standard Error|Mean
653088|NCT01991990|Primary|Neutrophil Redistribution Analysis on Day 5|On Day 4 participants had neutrophils isolated from 100 mL of ACD-anti-coagulated autologous venous blood and labeled with up to 2.5 MBq 111In-tropolonate before being reinjected. Participants rested for 45 min post-injection to allow for neutrophil equilibrium between the circulating and marginating neutrophil pools. Whole-body profiling was performed in a heavily shielded dedicated whole-body counter with 2 highly sensitive scintillation detectors with the recorded counts corrected for the physical decay of 111In to allow measurement of the effect of TCZ on the normal redistribution pattern of neutrophils and assessment of margination of neutrophils in the presence of TCZ. Distribution of radiolabelled neutrophils and peak counts, on Day 5 (24-hours post re-injection) in liver/spleen and pelvic bone marrow were decay corrected and expressed as percentages of Day 4 (45 minutes post re-injection).|Day 5|Safety analysis population. One participant in the PMN-high group was excluded due to external contamination affecting profiling data.||percentage of Day 4 counts||Standard Error|Mean
653113|NCT01990794|Secondary|Changes in Visual Function (Average RNFL Thickness)|Ophthalmology studies included an assessment of visual acuity, slit lamp evaluations, and visual field testing. Retinal nerve fiber layer (RNFL) thickness and optic nerve head (ONH) were assessed using optical coherence tomography (OCT). Volunteers served as their own baseline controls for changes during the study (i.e., week 0, ~day 45, ~day 90).|Baseline, at the study midpoint, and at the study completion|Participants that completed three months of cobalt supplementation||Average RNFL thickness (µm)||Standard Deviation|Mean
653089|NCT01991990|Primary|Neutrophil Redistribution Analysis on Day 4 (Neutrophil Nadir)|On Day 4 participants had neutrophils isolated from 100 milliliters (mL) of acid-citrate dextrose (ACD)-anti-coagulated autologous venous blood and labeled in autologous plasma with up to 2.5 megaBecquerel (MBq) 111 Indium (111In)-tropolonate before being reinjected. Participants rested for 45 minutes (min) post-injection to allow for neutrophil equilibrium between the circulating and marginating neutrophil pools. Whole-body profiling was performed in a heavily shielded dedicated whole-body counter with 2 highly sensitive scintillation detectors with the recorded counts corrected for the physical decay of 111In to allow measurement of the effect of TCZ on the normal redistribution pattern of neutrophils and assessment of margination of neutrophils in the presence of TCZ. Distribution of radiolabelled neutrophils on Day 4 (45 min post re-injection) in the blood, liver/spleen and pelvic bone marrow, expressed as percentages of total body counts (TBCs).|Day 4|Safety analysis population: Includes all the participants who received the single dose of randomized study medication. One participant in the polymorphonuclear leukocyte (PMN)-high group was excluded due to external contamination affecting profiling data.||percentage of total body count||Standard Error|Mean
653090|NCT01991548|Primary|User Acceptance of the New MiniMed 640G Insulin Pump and Guardian Link Transmitter|Descriptive summary will be used to characterize the results of the study questionnaires. The questionnaire will use a Likert scale (rating of 1 to 7) to assess subject acceptance of the MiniMed 640G, Guardian Link Transmitter, and the training materials. A response of 4 or greater will be considered positive on a Likert scale for training materials and product acceptance.|Four weeks of pump wear|||units on a scale||Standard Deviation|Mean
653091|NCT01991314|Secondary|Changes in Stress Levels|Perceived Stress Questionnaire (PSQ)-G is a 30-question measure of perceived stress giving total scores ranging between 30 (very unstressed) to 120 (very stressed).|Baseline (0 weeks) and end of trial (6 weeks)|Per protocol analysis||units on a scale||Standard Error|Mean
653092|NCT01991314|Secondary|Changes in Fatigue|Multidimensional Fatigue Inventory (MFI) is a 20 question-based scale with total scores ranging between 20 (very good) and 100 (very severe fatigue).|Baseline (0 weeks) and end of trial (6 weeks)|Per protocol||units on a scale||Standard Error|Mean
653093|NCT01991314|Secondary|Changes in Anxiety|Hospital Anxiety and Depression Score (HADS)-A, a scale of 7 questions score 0-3 each, so that total score 0 is good and 21 very severe anxiety.|Baseline (0 weeks) and end of trial (6 weeks)|Per protocol||units on a scale||Standard Error|Mean
653094|NCT01991314|Secondary|Change in Quality of Life Score|Short Inflammatory Bowel Disease Questionnaire (SIBDQ score), a health-related quality of life tool measuring physical, social, and emotional status (summated to produce a score of minimum 10 to maximum 70, representing poor to good quality of life, respectively). (Reporting of individual domain subscores is not valid).|Baseline (0 weeks) to end (6 weeks)|Per protocol analysis||scores on a scale||Standard Error|Mean
653095|NCT01991314|Secondary|Change in Disease Activity (Stool Calprotectin)|Difference between faecal calprotectin measured at baseline and at end of study|Baseline (0 weeks) and end of trial (6 weeks)|Per protocol analysis||ug/g||Standard Error|Mean
653096|NCT01991314|Secondary|Intolerance of Oral Iron|Numbers of patients who reported intolerance of oral iron (abdominal pain, nausea, vomiting, constipation, diarrhoea or headache)|Baseline (0 weeks) to end of trial (6 weeks)|||Participants|||Count of Participants
653097|NCT01991314|Primary|Mean Change in Haemoglobin Concentration.|Change in serum Hb concentration in g/dl after 6 weeks of oral iron|Baseline (0 weeks) and end of trial (6 weeks)|Intention to treat population||g/dl||Standard Error|Mean
653098|NCT01990898|Primary|Symptom Improvement of Interstitial Cystitis|Number of participants with > 30% Improved Interstitial Cystitis Symptoms Index (ICSI) which is measured on a scale from 0 - 19 where the higher numbers are worse. No additional analyses have been done.|3 Months|||Participants|||Number
653099|NCT01990859|Secondary|Percent of Participants With Best Overall Response (BOR) of Complete Response or Partial Response|Best Overall Response Rate (BORR) was defined as the total number of participants whose Best Overall Response (BOR) is Complete Response (CR) or Partial Response (PR) divided by the total number of treated participants (%). A two-sided, exact 95% Confidence Interval (Clopper and Pearson) for the BORR was calculated. Overall response (OR) was determined using modified World Health Organization (mWHO) criteria: Complete Response = complete disappearance of all index and non-index lesions, and no new lesions. Partial Response = decrease in index lesions of 50% or greater in a SPD relative to baseline, and no new lesions. BOR=an overall response of CR or PR at Week 12 or after Week 12.|Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)|All participants in the study who received at least one dose of treatment with ipilimumab were summarized.||percentage of participants||95% Confidence Interval|Number
653100|NCT01990859|Secondary|Number of Participants With Complete Response, Partial Response, Stable Disease, or Progressive Disease as the Best Overall Response|Overall response (OR) was determined using modified World Health Organization (mWHO) criteria. Complete response (CR): complete disappearance of all index and non-index lesions, and no new lesions. Partial response (PR): decrease in index lesions of 50% or greater in a sum of the products of diameters (SPD) relative to baseline, and no new lesions. Stable Disease (SD): Does not meet criteria for CR or PR, in the absence of PD in index lesions and no change or any change with persistence of one or more non-index lesions, and no new lesions. Progressive Disease (PD): At least 25% increase in SPD relative to nadir in index lesions and unequivocal progression of non-index lesions, along with new lesions or no new lesions; or PD: new lesions with any response with index or non-index lesions. Not Evaluable: Response cannot be determined.|Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)|All participants in the study who received at least one dose of treatment with ipilimumab were summarized.||participants|||Number
653101|NCT01990859|Secondary|Number of Participants With Renal Laboratory Abnormalities|Abnormal laboratory results were reported after the induction period start and within 90 days after induction period end date. Induction Period was 1 dose every 3 weeks for 4 doses (12 weeks). Common Terminology Criteria (CTC) version 3.0 was used in this study; Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling, Gr 5=Death. Renal parameter=Creatinine. The most recent assessment on or before Day 1 of study medication was taken as baseline (in addition, baseline laboratory must have been collected no earlier than Day -28).|Baseline to 90 days post last dose, up to July 2014|All participants in the study who received at least one dose of treatment with ipilimumab and had laboratory data were summarized. Data included up to July 2014.||participants|||Number
653102|NCT01990859|Secondary|Number of Participants With Liver Function Laboratory Abnormalities|Abnormal laboratory results were reported after the induction period start and within 90 days after induction period end date. Induction Period was 1 dose every 3 weeks for 4 doses (12 weeks). Common Terminology Criteria (CTC) version 3.0 was used in this study; Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling, Gr 5=Death. Liver Function parameters included: alanine aminotransaminase (ALT), aspartate aminotransferase (AST), Total Bilirubin, and Alkaline Phosphatase (Alk Phos). The most recent assessment on or before Day 1 of study medication was taken as baseline (in addition, baseline laboratory must have been collected no earlier than Day -28).|Baseline to 90 days post last dose, up to July 2014|All participants in the study who received at least one dose of treatment with ipilimumab and had laboratory data were summarized. Data included up to July 2014.||participants|||Number
653103|NCT01990859|Secondary|Number of Participants With Hematology Laboratory Abnormalities|Abnormal laboratory results were reported after the induction period start and within 90 days after induction period end date. Induction Period was 1 dose every 3 weeks for 4 doses (12 weeks). Common Terminology Criteria (CTC) version 3.0 was used in this study; Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling, Gr 5=Death. Hematology parameters included: White Blood Cell Count (WBC), Absolute Neutrophil Count, Platelet Count, Hemoglobin, and Lymphocyte Count (absolute). The most recent assessment on or before Day 1 of study medication was taken as baseline (in addition, baseline laboratory must have been collected no earlier than Day -28).|Baseline to 90 days post last dose, up to July 2014|All participants in the study who received at least one dose of treatment with ipilimumab and had laboratory data were summarized. Data included up to July 2014.||participants|||Number
653104|NCT01990859|Secondary|Number of Participants Who Died - All Treated Participants|Total number of deaths that occurred in all treated participants by study completion are reported.|Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)|All participants in the study who received at least one dose of treatment with ipilimumab were summarized.||participants|||Number
653105|NCT01990859|Secondary|Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation of Study Drug, Related AEs, Immune-related AEs (IrAEs) - All Treated Participants|AEs graded using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling, Gr 5=Death. Related=relationship to study drug reported as certain, probable, possible, or missing. Immune-related AEs (irAEs) characterized by potential association with inflammation and considered by investigator as drug related.|Day 1 to 90 Days after the last dose, up to July 2014|All participants in the study who received at least one dose of treatment with ipilimumab were summarized.||participants|||Number
653106|NCT01990859|Primary|Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation of Study Drug, Related AEs, Immune-related AEs (IrAEs) at Primary Endpoint - All Treated Participants|AEs graded using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling, Gr 5=Death. Related=relationship to study drug reported as certain, probable, possible, or missing. Immune-related AEs (irAEs) characterized by potential association with inflammation and considered by investigator as drug related. Primary endpoint (PE) includes results from Day 1 to 12 weeks after initial dose of last participant. Data evaluated at PE last patient, last visit (LPLV).|Day 1 to 90 Days after the last dose, up to May 2014|All participants in the study who received at least one dose of treatment with ipilimumab were summarized. Data up to May 2014 included.||participants|||Number
653107|NCT01990794|Secondary|Changes in Neurological Function (Velocity)|Values of the sural sensory and peroneal motor variables. Volunteers served as their own baseline controls for changes during the study (i.e., week 0, ~day 45, ~day 90, and ~4-6 post-weeks).|Baseline, at the study midpoint, and at the study completion|Participants that completed three months of cobalt supplementation||m/s||Standard Deviation|Mean
653108|NCT01990794|Secondary|Changes in Neurological Function (Sural Sensory Amplitude)|Values of the sural sensory and peroneal motor variables. Volunteers served as their own baseline controls for changes during the study (i.e., week 0, ~day 45, ~day 90, and ~4-6 post-weeks).|Baseline, at the study midpoint, and at the study completion|Participants that completed three months of cobalt supplementation||Sural Sensory Amplitude (µV)||Standard Deviation|Mean
653109|NCT01990794|Secondary|Changes in Visual Function (Mean Deviation and PSD)|Ophthalmology studies included an assessment of visual acuity, slit lamp evaluations, and visual field testing. Retinal nerve fiber layer (RNFL) thickness and optic nerve head (ONH) were assessed using optical coherence tomography (OCT). Volunteers served as their own baseline controls for changes during the study (i.e., week 0, ~day 45, ~day 90).|Baseline, at the study midpoint, and at the study completion|||dB||Standard Deviation|Mean
653110|NCT01990794|Secondary|Changes in Visual Function (VFI)|Ophthalmology studies included an assessment of visual acuity, slit lamp evaluations, and visual field testing. Retinal nerve fiber layer (RNFL) thickness and optic nerve head (ONH) were assessed using optical coherence tomography (OCT). Volunteers served as their own baseline controls for changes during the study (i.e., week 0, ~day 45, ~day 90).|Baseline, at the study midpoint, and at the study completion|||VFI (%)||Standard Deviation|Mean
653111|NCT01990794|Secondary|Changes in Visual Function (Cup Volume)|Ophthalmology studies included an assessment of visual acuity, slit lamp evaluations, and visual field testing. Retinal nerve fiber layer (RNFL) thickness and optic nerve head (ONH) were assessed using optical coherence tomography (OCT). Volunteers served as their own baseline controls for changes during the study (i.e., week 0, ~day 45, ~day 90).|Baseline, at the study midpoint, and at the study completion|||mm^3||Standard Deviation|Mean
664952|NCT01778751|Primary|Diabetes Control|Hemoglobin A1c as measured at baseline, 3m, 6m|Baseline, 3months, 6months|||percentage of glycosylated hemoglobin||Standard Deviation|Mean
653116|NCT01990794|Primary|Cobalt Serum Concentrations|The cobalt concentration in whole blood and serum was determined one to two weeks pre-dosing and on the day of the first day of dosing before taking the supplement. Samples were also analyzed during the dosing period as follows: Day 4/5, Day 8/9, Day 14/16, Day 22/23, Day 29/30, Day 43/44, Day 57/58, Day 71/72, and Day 88/90. Cobalt concentration in whole blood and serum was also determined at one, two, six, ten and 16 weeks post-dosing.|Before, during and after cobalt supplementation|Participants that completed three months of cobalt supplementation||µg Co/L||Standard Deviation|Mean
653117|NCT01990794|Secondary|Cobalt Urine Concentrations After Cessation of Cobalt Supplementation|A 24 hr urine collection for cobalt analysis was performed on three volunteers (two females and one male) at one, two, six and ten weeks post-dosing. The one male volunteer provided three consecutive 24-hr urine samples at the one and two week post-dosing time points; data for individual urine collections were averaged together to give an average one and two week post-dosing data concentration.|After cobalt supplementation|"Participants that completed three months of cobalt supplementation and volunteered to do additional urine collections after stopping cobalt supplementation. n represents the number of urine samples analyzd at each time point."||µg/L||Standard Deviation|Mean
653118|NCT01990794|Secondary|Cobalt Urine Concentrations|A 24 hr urine collection for cobalt analysis was performed at Day 14/16, Day 43/44 and Day 88/90.|During cobalt supplementation|Participants that completed three months of cobalt supplementation||µg/L||Standard Deviation|Mean
653119|NCT01990794|Secondary|Glucose Levels After 1, 2 and 3 Months of Dosing|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.|Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)|Participants that completed three months of cobalt supplementation. Individual male baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together. For females, the average baseline is the 1-wk predose data only because there was a significant difference between the 1-wk predose draw and the day 1 (predose) draw.||mg/dL||Standard Deviation|Mean
653120|NCT01990794|Secondary|Triglyceride Levels After 3 Months of Cobalt Supplementation|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Triglyceride levels were assessed before cobalt dietary supplementation and after three months of supplementation.|Study volunteers were assessed before and at the end of cobalt supplementation|Participants that completed three months of cobalt supplementation||mg/dL||Standard Deviation|Mean
653121|NCT01990794|Secondary|Total Cholesterol Levels After 3 Months of Cobalt Supplementation|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Total cholesterol levels were assessed before cobalt dietary supplementation and after three months of supplementation.|Study volunteers were assessed before and at the end of cobalt supplementation|Participants that completed three months of cobalt supplementation||mg/dL||Standard Deviation|Mean
653122|NCT01990794|Secondary|HDL Cholesterol Levels After 3 Months of Cobalt Supplementation|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. HDL cholesterol levels were assessed before cobalt dietary supplementation and after three months of supplementation.|Study volunteers were assessed before and at the end of cobalt supplementation|Participants that completed three months of cobalt supplementation||mg/dL||Standard Deviation|Mean
653123|NCT01990794|Secondary|Aspartate Aminotransferase (AST) Levels After 1, 2 and 3 Months of Dosing|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.|Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)|Participants that completed three months of cobalt supplementation. Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.||U/L||Standard Deviation|Mean
653124|NCT01990794|Secondary|Alanine Aminotransferase (ALT) Levels After 1, 2 and 3 Months of Dosing|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.|Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)|Participants that completed three months of cobalt supplementation. Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.||U/L||Standard Deviation|Mean
653125|NCT01990794|Secondary|Creatinine Levels After 1, 2 and 3 Months of Dosing|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.|Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)|Participants that completed three months of cobalt supplementation. Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.||mg/dL||Standard Deviation|Mean
653145|NCT01990703|Primary|Breastfeeding Continuation Rates at 8 Weeks Postpartum|To determine breastfeeding continuation rates at 8 weeks in women randomized to immediate post-placental vs. delayed (4-8 weeks) postpartum levonorgestrel IUD insertion.|8 weeks postpartum|147 Early IUD Insertion participants at baseline drops to 112 at 8 weeks due to exclusions for medical complications (n=15), inability to provide immediate IUD (n=7) and loss to follow up (n=13). In the Standard Insertion group 138 at baseline drops to 102 at 8 weeks with medical comps (n=11), failure to receive IUD (n=24), and 1 loss to follow up.||Participants|||Count of Participants
653126|NCT01990794|Secondary|Creatine Creatine Kinase–Myocardial Band (CK-MB) Levels After 1, 2 and 3 Months of Dosing|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.|Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)|Participants that completed three months of cobalt supplementation. Individual female baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together. For males, the average baseline is the 1-wk predose data only because there was a significant difference between the 1-wk predose draw and the day 1 (predose) draw.||ng/mL||Standard Deviation|Mean
653127|NCT01990794|Secondary|Ferritin Levels After 1, 2 and 3 Months of Dosing|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.|Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)|Participants that completed three months of cobalt supplementation. Individual female baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together. For males, the average baseline is the 1-wk predose data only because there was a significant difference between the 1-wk predose draw and the day 1 (predose) draw.||ng/mL||Standard Deviation|Mean
653128|NCT01990794|Secondary|Total Iron Levels After 1, 2 and 3 Months of Dosing|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.|Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)|Participants that completed three months of cobalt supplementation. Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.||µg/dL||Standard Deviation|Mean
653129|NCT01990794|Secondary|T4 Levels After 1, 2 and 3 Months of Dosing|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.|Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)|Participants that completed three months of cobalt supplementation.Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.||ng/dL||Standard Deviation|Mean
653130|NCT01990794|Secondary|Thyroid-Stimulating Hormone (TSH) Levels After 1, 2 and 3 Months of Dosing|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.|Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)|Participants that completed three months of cobalt supplementation. Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.||mIU/L||Standard Deviation|Mean
653131|NCT01990794|Secondary|Albumin Levels After 1, 2 and 3 Months of Dosing|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.|Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)|Participants that completed three months of cobalt supplementation. Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.||g/dL||Standard Deviation|Mean
653132|NCT01990794|Secondary|Protein Levels After 1, 2 and 3 Months of Dosing|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.|Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)|Participants that completed three months of cobalt supplementation. Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.||g/dL||Standard Deviation|Mean
653133|NCT01990794|Secondary|Hematocrit Levels After 1, 2 and 3 Months of Dosing|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.|Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)|Participants that completed three months of cobalt supplementation. Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.||Percentage||Standard Deviation|Mean
653146|NCT01990677|Other Pre-specified|Proportion of Patients Having a Reduction in Subfoveal Fluid on OCT Measurement|Placebo versus eplerenone acute CSCR patients will be measured at month 1 and placebo versus eplerenone chronic cscr patients will be measured at month 2.|Month 1 for acute CSCR patients and Month 2 for chronic CSCR patients.|Significant acute data collection missing therefore only chronic arm data analysis was reviewed and entered into results data.||Participants|||Count of Participants
653519|NCT01982435|Secondary|Anatomically Dry Eyes by SDOCT|Number of participants with an anatomically “dry” study eye by SDOCT at months 6 and 12|Months 6 and 12|||Participants|||Count of Participants
653134|NCT01990794|Secondary|Red Blood Cell (RBC) Levels After 1, 2 and 3 Months of Dosing|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.|Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)|Participants that completed three months of cobalt supplementation. Individual male baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together. For females, the average baseline is the 1-wk predose data only because there was a significant difference between the 1-wk predose draw and the day 1 (predose) draw.||million cells/µL||Standard Deviation|Mean
653135|NCT01990794|Secondary|White Blood Cell (WBC) Levels After 1, 2 and 3 Months of Cobalt Dietary Supplementation|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.|Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)|Participants that completed three months of cobalt supplementation. Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.||thousand cells/µL||Standard Deviation|Mean
653136|NCT01990794|Primary|Cobalt Whole Blood Concentrations|The cobalt concentration in whole blood and serum was determined one to two weeks pre-dosing and on the day of the first day of dosing before taking the supplement. Samples were also analyzed during the dosing period as follows: Day 4/5, Day 8/9, Day 14/16, Day 22/23, Day 29/30, Day 43/44, Day 57/58, Day 71/72, and Day 88/90. Cobalt concentration in whole blood and serum was also determined at one, two, six, ten and 16 weeks post-dosing.|Before, during and after cobalt supplementation|Participants that completed three months of cobalt supplementation||µg Co/L||Standard Deviation|Mean
653137|NCT01990794|Secondary|Changes in Neurological Function (Peroneal Motor Amplitude)|Values of the sural sensory and peroneal motor variables. Volunteers served as their own baseline controls for changes during the study (i.e., week 0, ~day 45, ~day 90, and ~4-6 post-weeks).|Baseline, at the study midpoint, and at the study completion|Participants that completed three months of cobalt supplementation||Peroneal Motor Amplitude (mV)||Standard Deviation|Mean
653138|NCT01990794|Secondary|Changes in Visual Function|Ophthalmology studies included an assessment of visual acuity, slit lamp evaluations, and visual field testing. Retinal nerve fiber layer (RNFL) thickness and optic nerve head (ONH) were assessed using optical coherence tomography (OCT). Volunteers served as their own baseline controls for changes during the study (i.e., week 0, ~day 45, ~day 90).|Baseline, at the study midpoint, and at the study completion|Participants that completed three months of cobalt supplementation||mm^2||Standard Deviation|Mean
653139|NCT01990794|Secondary|Changes in Cardiac Function|Two-dimensional and Doppler echocardiographic examinations were used to assess cardiac anatomy, structure, and function during the study with volunteers serving as their own baseline controls for changes during the study (i.e., week 0, ~day 45, ~day 90).|Baseline, at the study midpoint, and at the study completion|Participants that completed three months of cobalt supplementation||cm||Standard Deviation|Mean
653140|NCT01990794|Secondary|Changes in Audiological Function|Audiologic assessments including pure tone threshold determination at frequencies ranging from 250 to 16000 Hz were performed with volunteers serving as their own baseline controls for receptive changes during the study (i.e., week 0, ~day 45, ~day 90). Audiologic assessments including a pure-tone threshold determination at frequencies that ranged from 250 to 16000 Hz were performed with volunteers serving as their own baseline controls for receptive changes during the study. Decreases in hearing were considered clinically significant when one of the following 3 American Speech-Language-Hearing Association criteria were met: 1) a ≥20-dB decrease in the pure-tone threshold at one test frequency, 2) a ≥10-dB decrease at 2 adjacent test frequencies, or 3) the loss of 3 consecutive test frequencies where responses were previously obtained.|Baseline, at the study midpoint, and at the study completion|Participants that completed three months of cobalt supplementation||dB||Standard Deviation|Mean
653141|NCT01990794|Secondary|Hemoglobin Levels After 1, 2 and 3 Months of Dosing|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.|Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)|Participants that completed three months of cobalt supplementation. Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.||g/dL||Standard Deviation|Mean
653142|NCT01990794|Secondary|Effects on the Immune System|Sensitivity to metals before and after cobalt supplementation was assessed by an in vitro lymphocyte transformation test (LTT) performed at week 0 and after three months of cobalt supplementation. The average proliferation rate for each metal treatment was normalized to individual proliferation rates of untreated control cells which generated a stimulation index (SI). According to the manufacture, the SI ranges from 0-15, with an SI from 2 to 4 indicated mild reactivity, from 5 to 8 indicated moderate reactivity, and >8 indicated high reactivity to the metal. The data is presented as the averaged normalized lymphocyte transformation response to each metal in men and women combined (n = 10).|0 weeks and three months|Participants that completed three months of cobalt supplementation||units on a scale: stimulation index (SI)||Standard Deviation|Mean
653143|NCT01990794|Secondary|Albumin Bound Cobalt Fraction in Serum|The fraction of albumin bound cobalt in serum was determined one to two weeks pre-dosing and on the day of the first dose before taking the supplement. Samples were also analyzed during the dosing period as follows: Day 4/5, Day 8/9, Day 14/16, Day 22/23, Day 29/30, Day 43/44, Day 57/58, Day 71/72, Day 88/90 and the fraction of albumin bound cobalt in serum was also determined at one and two weeks post-dosing.|Study volunteers will be followed for the duration of the study, an average of about 8 months for most volunteers|Analysis was carried out on the first 12 participants of the study||percentage of total blood cobalt||Standard Deviation|Mean
653144|NCT01990703|Secondary|Time to Lactogenesis Stage 2|To evaluate potential delay in lactogenesis caused by immediate postpartum insertion of the LNG IUD.|First 5 days after birth|||Hours||Standard Deviation|Mean
653147|NCT01990677|Secondary|Mean Change in Subfoveal Fluid Height Based on OCT Measurement|Placebo versus eplerenone acute CSCR patients will be measured at month 1 and placebo versus eplerenone chronic CSCR patients will be measured at month 2.|Month 1 for acute CSCR patients, Month 2 in chronic CSCR patients|Significant acute data collection missing therefore only chronic arm data analysis was reviewed and entered into results data.||microns||Standard Deviation|Mean
653148|NCT01990677|Primary|Maximal Subretinal Fluid Height Based on Spectral Domain Optical Coherence Tomography (OCT) Measurement.|Placebo versus eplerenone acute CSCR patients will have sub-foveal fluid measured at month 1, and placebo versus eplerenone chronic cscr patients will be have sub-foveal fluid measured at month 2.|At 1 month in acute CSCR and 2 months in chronic CSR patients|Significant acute data collection missing therefore only chronic arm data analysis was reviewed and entered into results data.||microns||Standard Deviation|Mean
653149|NCT01990664|Primary|Proportion of Successfully Re-fitted Subjects|Percentage of lapsed contact wearers who were successfully refitted among subjects who have lapsed from contact lens use more than 6 months prior to the date of enrollment in the study. Successful fit was assessed by on eye care practitioner (ECP) judgment of acceptable physiology.|4 weeks|The analysis population includes all subjects who have completed all study visits without a major protocol deviation.||percentage of Subjects|||Number
653150|NCT01990534|Secondary|Number of Participants With Antitherapeutic Antibodies (ATA)|Blood samples were collected to assess the immunogenicity of brentuximab vedotin (ATA development) using a laboratory test. Confirmed ATA-positive response was categorized as transient (defined as 1 or 2 post-Baseline confirmed ATA-positive responses) and persistent (defined as more than 2 post-Baseline confirmed ATA positive responses) and neutralizing ATA (nATA) status. The confirmed ATA-positive samples were assessed for ATA titer and delineated into having high or low titers.|Day 1 of every 3-week cycle up to 16 cycles and EOT (Up to 12.2 months)|Participants from the Safety Population, all enrolled participants who received at least one dose of brentuximab vedotin, with data available for analysis.||participants|||Number
653151|NCT01990534|Secondary|Monomethyl Auristatin E (MMAE) Serum Concentrations|Blood samples were collected and tested for MMAE serum concentrations.|Cycle 1 pre-dose and 10 minutes, 24 hours and 336 hours post-dose; Cycle 2 pre-dose and 10 minutes post-dose; Cycle 3 pre-dose and 10 minutes, 24 hours and 336 hours post-dose; Cycle 4 to 16 pre-dose and 10 minutes post-dose; EOT (Up to 12.2 months)|"PK-evaluable population was defined as participants with sufficient dosing and PK data to reliably estimate PK parameters. n in the categories is the number of participants with data available at the given time-point."||pg/mL||Standard Deviation|Mean
653152|NCT01990534|Secondary|Serum Concentration of Total Antibodies (Conjugated and Unconjugated)|Blood samples were collected and tested for conjugated and unconjugated antibodies.|Cycle 1 pre-dose and 10 minutes, 24 hours and 336 hours post-dose; Cycle 2 pre-dose and 10 minutes post-dose; Cycle 3 pre-dose and 10 minutes, 24 hours and 336 hours post-dose; Cycle 4 to 16 pre-dose and 10 minutes post-dose; EOT (Up to 12.2 months)|"PK-evaluable population was defined as participants with sufficient dosing and PK data to reliably estimate PK parameters. n in the categories is the number of participants with data available at the given time-point."||ng/mL||Standard Deviation|Mean
653153|NCT01990534|Secondary|Antibody-drug Conjugate (ADC) Serum Concentrations|Blood samples were collected and tested for serum concentrations of brentuximab vedotin antibody-drug conjugate.|Cycle 1 pre-dose and 10 minutes, 24 hours and 336 hours post-dose; Cycle 2 pre-dose and 10 minutes post-dose; Cycle 3 pre-dose and 10 minutes, 24 hours and 336 hours post-dose; Cycle 4 to 16 pre-dose and 10 minutes post-dose; EOT (Up to 12.2 months)|"Pharmacokinetic (PK) evaluable population was defined as participants with sufficient dosing and PK data to reliably estimate PK parameters. n in the categories is the number of participants with data available at the given time-point."||ng/mL||Standard Deviation|Mean
653154|NCT01990534|Secondary|Number of Participants With Abnormal Clinical Laboratory Values Reported as AEs|Abnormal clinical laboratory values (serum chemistry and hematology) were reported as AEs if they were considered by the investigator to be a clinically significant change from Baseline or led to premature discontinuation of study treatment, dose modification, or other therapeutic intervention.|From the first dose through 30 days after the last dose of study medication (Up to 12.2 months)|Safety population was defined as all enrolled participants who received at least one dose of brentuximab vedotin.||participants|||Number
653155|NCT01990534|Secondary|Number of Participants With Adverse Events (AEs), Drug-Related AEs, Grade 3 or Higher AEs, Serious Adverse Events (SAEs), Drug-Related SAEs and Grade 3 or Higher SAEs|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A Serious Adverse Event (SAE) A serious is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. AE severity was graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. AEs Grade 3 and higher are severe.|From first dose through 30 days after the last dose of study medication [Up to 12.2 months, except for peripheral neuropathy (PN), all PN events will be followed for all changes in severity until resolution to baseline or study closure (Up to 24 months)]|Safety population was defined as all enrolled participants who received at least one dose of brentuximab vedotin.||participants|||Number
653156|NCT01990534|Secondary|Percentage of Participants Who Received Stem Cell Transplantation (SCT)||Baseline up to EOS (Up to 24 months)|ITT population included all participants who were enrolled in the study.||percentage of participants|||Number
653157|NCT01990534|Secondary|Overall Survival (OS)|OS is the time in months from start of study treatment to date of death due to any cause.|Every 3 months for 18 months after EOT, thereafter, every 6 months until the sooner of death, study closure, or 5 years after enrollment of the last participant up to data cut-off: 24 March 2016 (approximate median follow-up 16.6 months)|ITT population included all participants who were enrolled in the study. In the absence of confirmation of death, survival time is censored at the last date the participant is known to be alive, including study closure.||months||95% Confidence Interval|Median
653520|NCT01982435|Secondary|Mean Change in Central Foveal Thickness|Mean absolute change from baseline central foveal thickness at months 6 and 12 as measured by SDOCT (defined as the average thickness within the central 1 mm subfield)|Months 6 and 12|||microns||Standard Deviation|Mean
653158|NCT01990534|Secondary|Duration of Complete Remission (CR)|Duration of CR is defined as the time from the date of first documentation of a CR or to the date of first documentation of tumor progression or progressive disease (PD) per IRF assessment according to IWG criteria. CR is defined as the disappearance of all evidence of disease and PD is defined as any new lesion or increase by >50% of previously involved sites from nadir.|From first documented response until disease progression (Up to 24 months)|ITT population included all participants who were enrolled in the study. In the absence of confirmation of death, survival time is censored at the last date the patient is known to be alive, including study closure.||months||95% Confidence Interval|Median
653159|NCT01990534|Secondary|Complete Remission Rate|Complete remission rate is defined as percentage of participants with CR per IRF response assessment based on IWG criteria are reported. CR is defined as the disappearance of all evidence of disease.|Baseline until disease progression, death or EOS (Up to 24 months)|ITT population included all participants who were enrolled in the study. In the absence of confirmation of death, survival time is censored at the last date the participant is known to be alive, including study closure.||percentage of participants||95% Confidence Interval|Number
653160|NCT01990534|Secondary|Progression Free Survival (PFS)|PFS is defined as time in months from start of study treatment to first documentation of objective tumor progression per IRF assessment or up to death due to any cause, whichever occurs first.|Baseline until disease progression, death or end of treatment (EOT), and then every 3 months up to data cut-off: 24 March 2016 (approximate median follow-up 6.9 months)|ITT population included all participants who were enrolled in the study. For a participant that has not progressed and has not died, PFS is censored at the last response assessment that is SD or better.||months||95% Confidence Interval|Median
653161|NCT01990534|Secondary|Duration of Response (DOR)|DOR is defined as the time in months from the date of first documentation of a CR response to the date of first documentation of tumor progression or progressive disease (PD) per IRF assessment according to IWG criteria. CR is defined as the disappearance of all evidence of disease and PD is defined as any new lesion or increase by >50% of previously involved sites from nadir.|From first documented response until disease progression (Up to 24 months)|ITT population included all participants who were enrolled in the study. All responders were evaluated in this outcome measure. For a participant that has not progressed, DOR is censored at the last response assessment that is SD or better.||months||95% Confidence Interval|Median
653162|NCT01990534|Primary|Objective Response Rate (ORR)|Objective response rate is defined as the percentage of participants with complete remission (CR) or partial remission (PR) as assessed by an independent review facility (IRF) using International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma. CR is defined as the disappearance of all evidence of disease and PR is defined as regression of measurable disease and no new sites.|Baseline until disease progression, death or end of study (EOS) (Up to 24 months)|Intent-to-Treat (ITT) population included all participants who were enrolled in the study.||percentage of participants||95% Confidence Interval|Number
653163|NCT01990339|Secondary|Frequency of Adverse Events (Adverse Drug Reactions)|Adverse events observed during the observation period were collected by symptom. For adverse drug reactions, frequencies were tabulated by type and seriousness. Adverse events were defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with administration of lansoprazole whether or not it was considered related to treatment. Among these, events that were considered as having a causal relationship with lansoprazole were defined as adverse drug reactions. The rate of participants with adverse events (adverse drug reactions) was reported.|4 Weeks|Safety analysis set included all enrolled participants with data available (8 patients were excluded for Investigator's medical reasons; 41 were excluded for other reasons), 1402 patients who did not visit the study site after initial prescription were also excluded.||percentage of participants|||Number
653164|NCT01990339|Primary|Subjective Symptom Improvement Rate|Subjective symptoms were evaluated as “Disappeared,” “Improved,” “No change,” “Worsened,” or “Unclear.” These categories were based on investigator's definitions. At Week 4, the rate of improvement (i.e. the frequency of an evaluation of “Disappeared” + “Improved”) was calculated for each symptom. The percentage of participants with Improvement by symptom was reported.|Start of treatment and Week 4|Efficacy set included all enrolled participants with data available (8 patients were excluded for Investigator's medical reasons; 41 were excluded for other reasons), 1402 patients who did not visit the study site after initial prescription and 861 patients whose questionnaires were not reviewed at either Week 2 or Week 4 were also excluded.||percentage of participants|||Number
653165|NCT01990261|Secondary|Overall Survival According to Prior Chemotherapy Treatment.|Prior chemotherapy treatment is presented as reported by the investigators.|Up to 12 months|Analysis was performed on all enrolled participants.||days||Standard Error|Mean
653166|NCT01990261|Secondary|Percentage of Participants With Adverse Events (AEs)|An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Up to 12 months|Analysis was performed on all enrolled participants.||percentage of participants|||Number
653167|NCT01990261|Secondary|Overall Survival (OS)|OS is defined as time from first administration of study drug until death from any cause.|Up to 12 months|Analysis was performed on all enrolled participants.||days||Standard Error|Mean
653168|NCT01990261|Primary|Progression Free Survival (PFS) at Month 12|PFS is defined as the time from inclusion in the study to the disease progression or death whichever occurs first. Disease progression was determined according to local treatment guidelines.|From inclusion up to disease progression or death whichever occurs first (up to 12 months)|Analysis was performed on all enrolled participants.||days||95% Confidence Interval|Median
653169|NCT01990261|Primary|Progression Free Survival (PFS) at Month 6|PFS is defined as the time from inclusion in the study to the disease progression or death whichever occurs first. Disease progression was determined according to local treatment guidelines.|From inclusion up to disease progression or death whichever occurs first (up to 6 months)|Analysis was performed on all enrolled participants.||days||95% Confidence Interval|Median
653170|NCT01990261|Primary|Survival Rate at Month 12||Month 12|Analysis was performed on all enrolled participants.||percentage of participants|||Number
653171|NCT01990261|Primary|Survival Rate at Month 6||Month 6|Analysis was performed on all enrolled participants.||percentage of participants|||Number
653172|NCT01989689|Primary|Vascular Function as Measured by Brachial Artery Flow Mediated Dilation (FMD)|Ultrasonography of the brachial artery performed at the bedside using a high-resolution 10-megahertz (MHz) ultrasound transducer before and after suprasystolic inflation of a blood pressure cuff for 5 minutes in the ipsilateral upper arm. Brachial artery FMD was calculated as (hyperemic diameter − 6 month diameter)/6 month diameter × 100.|6 months|||percentage of brachial artery diameter||Standard Deviation|Mean
653173|NCT01989689|Primary|Vascular Function as Measured by Brachial Artery Flow Mediated Dilation (FMD)|Ultrasonography of the brachial artery performed at the bedside using a high-resolution 10-megahertz (MHz) ultrasound transducer before and after suprasystolic inflation of a blood pressure cuff for 5 minutes in the ipsilateral upper arm. Brachial artery FMD was calculated as (hyperemic diameter − 3 month diameter)/3 month diameter × 100.|3 months|||percentage of brachial artery diameter||Standard Deviation|Mean
653174|NCT01989689|Primary|Vascular Function as Measured by Brachial Artery Flow-mediated Dilation (FMD)|Ultrasonography of the brachial artery performed at the bedside using a high-resolution 10-megahertz (MHz) ultrasound transducer before and after suprasystolic inflation of a blood pressure cuff for 5 minutes in the ipsilateral upper arm. Brachial artery FMD was calculated as (hyperemic diameter − baseline diameter)/baseline diameter × 100.|Baseline|||percentage of brachial artery diameter||Standard Deviation|Mean
653175|NCT01989572|Secondary|5-year Recurrence Free Survival Rate|Recurrence free survival is defined as time from randomization to first disease recurrence or death from any cause (whichever occur first), censoring cases without recurrence or death at the last date of known free of recurrence free survival events, and 5-year overall survival rate is estimated via Kaplan-Meier method. Disease recurrence was determined based on positive cytology or biopsy in the presence of a single new lesion or the appearance of multiple lesions consistent with metastatic disease, or a positive brain CT or MRI scan or CSF cytology.|assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years, up to year 15|all randomized patients, regardless of eligibility||percentage of participants||95% Confidence Interval|Number
653176|NCT01989572|Secondary|5-year Overall Survival Rate|Overall survival is defined as time from randomization to death from any cause, and 5-year overall survival rate is estimated via Kaplan-Meier method.|assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years, up to year 15|all randomized patients, regardless of eligibility||percentage of participants||95% Confidence Interval|Number
653177|NCT01989572|Secondary|Recurrence Free Survival in HLA-A2 Positive Patients|Recurrence free survival is defined as time from randomization to first disease recurrence or death from any cause (whichever occur first), censoring cases without recurrence or death at the last date of known free of recurrence free survival events. Disease recurrence was determined based on positive cytology or biopsy in the presence of a single new lesion or the appearance of multiple lesions consistent with metastatic disease, or a positive brain CT or MRI scan or CSF cytology.|assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years, up to year 15|all HLA-A2 positive patients||months||95% Confidence Interval|Median
653178|NCT01989572|Secondary|Overall Survival in Human Leukocyte Antigens-A2 (HLA-A2) Positive Patients|Overall survival is defined as time from randomization to death from any cause.|assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years,up to year 15|all HLA-A2 positive patients||months||95% Confidence Interval|Median
653179|NCT01989572|Primary|Recurrence Free Survival|Recurrence free survival is defined as time from randomization to first disease recurrence or death from any cause (whichever occur first), censoring cases without recurrence or death at the last date of known free of recurrence free survival events. Disease recurrence was determined based on positive cytology or biopsy in the presence of a single new lesion or the appearance of multiple lesions consistent with metastatic disease, or a positive brain CT or MRI scan or CSF cytology.|assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years, up to year 15|all randomized patients, regardless of eligibility||months||95% Confidence Interval|Median
653180|NCT01989572|Primary|Overall Survival|Overall survival is defined as time from randomization to death from any cause.|assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years, up to year 15|all randomized patients, regardless of eligibility||months||95% Confidence Interval|Median
653181|NCT01989455|Secondary|Safety and Tolerability of a Single 1000 mg Oral Dose of Deferiprone|The number of participants who experienced adverse events (including any changes of clinical significance in physical examinations, vital signs, 12-lead ECG, and clinical laboratory tests) following a single dose of oral deferiprone. Note: All subjects in the 1000 mg cohort received active product, including the 2 who had received placebo for the intravenous infusion.|From dosing until 24 hours post-dose|The safety population included all subjects who received study product.||participants|||Number
653182|NCT01989455|Secondary|Absolute Bioavailability of Deferiprone|The pharmacokinetic profile was assessed over a 14-hour interval for deferiprone in healthy volunteers who received a single intravenous dose of 1000 mg and then one week later received a single oral dose of 1000 mg deferiprone oral solution. In both cases, blood samples were obtained pre-dose and at 0.17, 0.33, 0.50, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 4, 6, 9, 12, and 14 hours post-dose.|14-hour interval|The pharmacokinetic population included all subjects who had sufficient data to derive the value of at least one pharmacokinetic parameter.||μg*h/mL||Standard Deviation|Mean
653183|NCT01989455|Secondary|Comparison of Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide Between Deferiprone for Infusion and Oral Deferiprone|Cmax was assessed over a 14-hour interval for deferiprone in healthy volunteers who received a single intravenous dose of 1000 mg and then one week later received a single oral dose of 1000 mg deferiprone oral solution. In both cases, blood samples were obtained pre-dose and at 0.17, 0.33, 0.50, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 4, 6, 9, 12, and 14 hours post-dose.|14-hour interval|The pharmacokinetic population included all subjects who had sufficient data to derive the value of at least one pharmacokinetic parameter.||μg/mL||Standard Deviation|Mean
653384|NCT01986751|Secondary|Compare the Opioid Consumption During the First 24 Hours Between the Study Group and the Control Group|Mg equivalent of morphine consumption during the first 24 hours between the study group and the control group|baseline to 24 hours post block|Study was prematurely terminated. No data were collected for this assessment|||||
653184|NCT01989455|Primary|Safety and Tolerability of Single Ascending Doses of Deferiprone When Administered by Intravenous Infusion in Healthy Volunteers.|The number of participants who experienced adverse events (including any changes of clinical significance in physical examinations, vital signs, 12-lead ECG, and clinical laboratory tests) following a single dose of intravenous deferiprone.|From start of intravenous dosing until Day 5 post-dose for all subjects; and from time of oral dose until 24 hours post-dose for subjects who additionally received oral deferiprone|The safety population included all subjects who received study product.||participants|||Number
653185|NCT01989455|Primary|The Terminal Elimination Half-life (T1/2el) for Serum Deferiprone and Deferiprone 3-O-glucuronide|T1/2el was assessed over a 14-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in healthy volunteers who received single intravenous doses of 500 mg, 1000 mg, 1500 mg, and 2000 mg of intravenous deferiprone. Blood samples were obtained pre-dose and at 0.17, 0.33, 0.50, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 4, 6, 9, 12, and 14 hours post-dose.|14-hour interval|The pharmacokinetic population included all subjects who had sufficient data to derive the value of at least one pharmacokinetic parameter.||hour||Standard Deviation|Mean
653186|NCT01989455|Primary|Area Under the Curve From Zero to Infinity (AUC0-∞) for Serum Deferiprone and Deferiprone 3-O-glucuronide|AUC0-∞ was assessed over a 14-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in healthy volunteers who received single intravenous doses of 500 mg, 1000 mg, 1500 mg, and 2000 mg of intravenous deferiprone. Blood samples were obtained pre-dose and at 0.17, 0.33, 0.50, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 4, 6, 9, 12, and 14 hours post-dose.|14-hour interval|The pharmacokinetic population included all subjects who had sufficient data to derive the value of at least one pharmacokinetic parameter.||μg*h/mL||Standard Deviation|Mean
653187|NCT01989455|Primary|Time to Maximum Observed Serum Concentration (Tmax) for Serum Deferiprone and Deferiprone 3-O-glucuronide|"Tmax was assessed over a 14-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in healthy volunteers who received single intravenous doses of 500 mg, 1000 mg, 1500 mg, and 2000 mg of intravenous deferiprone. Blood samples were obtained pre-dose and at 0.17, 0.33, 0.50, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 4, 6, 9, 12, and 14 hours post-dose.
The results of the Tmax parameter are reported as the median and range (other parameters are reported as mean and standard deviation)."|14-hour interval|The pharmacokinetic population included all subjects who had sufficient data to derive the value of at least one pharmacokinetic parameter.||hour||Full Range|Median
653188|NCT01989455|Primary|Maximum Measured Serum Concentration (Cmax) for Serum Deferiprone and Deferiprone 3-O-glucuronide|Cmax was assessed over a 14-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in healthy volunteers who received single intravenous doses of 500 mg, 1000 mg, 1500 mg, and 2000 mg of intravenous deferiprone. Blood samples were obtained pre-dose and at 0.17, 0.33, 0.50, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 4, 6, 9, 12, and 14 hours post-dose.|14-hour interval|||μg/mL||Standard Deviation|Mean
653189|NCT01989195|Secondary|Heart Rate: SAFETY AND TOLERABILITY OF MANGANESE CONTRAST REAGENT|"SUBJECTS UNDERWENT PRE- AND POST-MRI EKG TESTING TO ASSESS ANY ADVERSE SYMPTOMS OR SIGNS. THE POST EKG WAS PERFORMED AFTER MEMRI SCAN WERE COMPLETE. EKG WAS NOT OBTAINED BEFORE AND AFTER DEMRI.
Measured the difference in heart rate per EKG before and after MEMRI study."|Pre MRI and Post MRI on same day (Day 1)|||Heart Rate change in beats per minute||Standard Deviation|Mean
653190|NCT01989195|Secondary|Significant Cardiovascular Event|Hospitalization and procedures for chest pain, arrhythmias, and all-cause mortality|1 year|||participants|||Number
653191|NCT01989195|Secondary|SAFETY AND TOLERABILITY OF MANGANESE CONTRAST REAGENT|"QRS Duration: SUBJECTS UNDERWENT PRE- AND POST-MRI EKG TESTING TO ASSESS ANY ADVERSE SYMPTOMS OR SIGNS. THE POST EKG WAS PERFORMED AFTER MEMRI SCAN WERE COMPLETE. EKG WAS NOT OBTAINED BEFORE AND AFTER DEMRI.
Measured the difference in heart rate per EKG before and after MEMRI study."|Pre MRI and Post MRI on same day (Day 1)|||Change in QRS Duration in milliseconds||Standard Deviation|Mean
653192|NCT01989195|Primary|COMPARISON OF MYOCARDIAL INFARCTION SIZE MEASUREMENTS USING INVESTIGATIONAL MANGANESE-ENHANCED MRI (MEMRI) OR DELAYED GADOLINIUM ENHANCED MRI (DEMRI)|Measured as percentage of myocardial injury volume to the total left ventricular myocardial volume|Day 1 (1 MRI)|||percentage of infarct to Left Ventricle||Standard Deviation|Mean
653193|NCT01989169|Primary|Maximum Plasma Concentration (Cmax) of Midazolam|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Over 72 hours post-dose|Pharmacokinetic Set: All subjects who took at least 1 dose of investigational product and for whom the primary pharmacokinetic data were considered sufficient and interpretable.||ng/mL||Standard Deviation|Mean
653194|NCT01989169|Primary|Area Under the Concentration-time Curve From Time Zero to the Time of the Last Measureable Concentration (AUClast) of Midazolam|AUClast is the area under the concentration versus time curve from the time of dosing to the last measurable concentration. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Over 72 hours post-dose|Pharmacokinetic Set: All subjects who took at least 1 dose of investigational product and for whom the primary pharmacokinetic data were considered sufficient and interpretable.||ng*h/ml||Standard Deviation|Mean
653195|NCT01989169|Primary|Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of Midazolam|AUCinf is the area under the plasma concentration versus time curve extrapolated from time 0 to infinity, calculated using the observed value of the last non-zero concentration. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Over 72 hours post-dose|Pharmacokinetic Set: All subjects who took at least 1 dose of investigational product and for whom the primary pharmacokinetic data were considered sufficient and interpretable.||ng*hr/mL||Standard Deviation|Mean
653521|NCT01982435|Secondary|Mean Change in BCVA|Mean change in best-corrected visual acuity as assessed by the number of letters read correctly on the electronic ETDRS eye chart from baseline to months 6 and 12.|Months 6 and 12|||ETDRS letters||Standard Deviation|Mean
653201|NCT01989130|Primary|Resolution of Symptoms|Number of patients that report having no symptoms 7 to 10 days after initial encounter|one year|Analysis of patients who completed the 7-10 day follow-up phone call||Participants|||Count of Participants
653202|NCT01989130|Primary|Healthcare Cost|To quantify the amount billed to insurance companies and out of pocket expenses for initial encounter|one year|This outcome measure was not measured, as insurance coverage for hospital and physician charges was unavailable.|||||
653203|NCT01989130|Primary|Health Utilization|Quantify the number of visits to healthcare facilities/providers and non-ED related medications purchased in 7-10 days after enrollment|one year|Analysis included patients that responded to the 7-10 day follow-up phone call.||Participants|||Count of Participants
653204|NCT01989130|Primary|Percentage of Participants Prescribed Antibiotic Treatment|Measurement of the number and type of antibiotics prescribed to CT/NG + v. CT/NG - in both groups|one year|||percentage of 70 participants|||Number
653205|NCT01988857|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (From Day 0 to Day 30)|||Subjects|||Number
653206|NCT01988857|Primary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within 31 days (Days 0-30) post vaccination period|||Subjects|||Number
653207|NCT01988857|Primary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache and temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|Within 4 days (Days 0-3) post vaccination period|||Subjects|||Number
653208|NCT01988857|Primary|Numbers of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Relationship analysis was not performed.|Within 4 days (Days 0-3) post vaccination period|||Subjects|||Number
653209|NCT01988662|Primary|Percent Change From Baseline at Month 3 in Plasma VEGF Following Intravitreal (IVT) Injection of Anti-VEGF Agent|Percent change in blood VEGF level is calculated as the difference in blood VEGF level measured after 3 month of anti-VEGF agent IVT treatment (Ranibizumab or Aflibercept) when compared to baseline blood VEGF level.|Change from baseline at Month 3|Full Analysis Set (FAS): The FAS consisted of all randomized patients who received at least one dose of study treatment. FAS was the analysis set. However, patients who were randomized due to erroneous use of the IRT system and who did not receive at least one dose of study treatment were excluded from the FAS.||Percent change||Standard Error|Least Squares Mean
653210|NCT01988662|Secondary|Number of Patients With Ocular and Systemic Adverse Events|The incidence of reported treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAE).|Day 1 to day 85|Safety (SAF) analysis set: The SAF analysis set included all patients who received at least one dose of study treatment and had at least one post-baseline safety assessment.||Participants|||Number
653211|NCT01988662|Secondary|Mean Change From Baseline in Central Retinal Thickness (CRT) of the Study Eye Over Time|"CRT in micrometers assessed by Optical Tomography (OCT) at each single study visit. A reduction is thickness indicates an improvement is the lesion area.
Change from baseline calculated as observed post-baseline - baseline value."|Baseline, month 1, month 2, month 3|FAS: The FAS consisted of all randomized patients who received at least one dose of study treatment. FAS was the analysis set. However, patients who were randomized due to erroneous use of the IRT system and who did not receive at least one dose of study treatment were excluded from the FAS.||micrometers||Standard Deviation|Mean
653212|NCT01988662|Secondary|Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) of the Study Eye Over Time|BCVA score is assessed on study eye based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity charts at a testing distance of 4 meters. An increase in score indicates an improvement in acuity. Change from baseline calculated as observed post-baseline value - baseline value.|Baseline, month 1, month 2, month 3|FAS: The FAS consisted of all randomized patients who received at least one dose of study treatment. FAS was the analysis set. However, patients who were randomized due to erroneous use of the IRT system and who did not receive at least one dose of study treatment were excluded from the FAS.||Letter||Standard Deviation|Mean
653213|NCT01988662|Secondary|Correlation Between Percent Change From Baseline Plasma VEGF Level and the Serum Anti-VEGF Agent Overtime|VEGF level and anti-VEGF concentration measured in the blood at each single visit, including pre- and post-dose measurement at the dosing visits.|pre-dose to post-dose at Baseline, week 1, week 2, month 1, month 2, and month 3|FAS||pearson correlation coefficient||95% Confidence Interval|Number
653214|NCT01988662|Secondary|Percent Change From Baseline in Plasma VEGF Level Overtime|Plasma VEGF measurement performed at all visits and compared to baseline level|Change from baseline up to month 3|FAS: The FAS consisted of all randomized patients who received at least one dose of study treatment. FAS was the analysis set. However, patients who were randomized due to erroneous use of the IRT system and who did not receive at least one dose of study treatment were excluded from the FAS.||Percent change||Standard Error|Least Squares Mean
653215|NCT01988415|Primary|Percentage of Eyes Losing More Than 2 Lines of Best-corrected Distance Visual Acuity|Primary Safety Outcome Measure: percentage of eyes losing more than 2 lines of best-corrected distance visual acuity|3 Months|The analysis population was all evaluable eyes.||percentage of eyes|Participants||Number
653216|NCT01988415|Primary|Mean Postoperative Spherical Aberration|Primary Efficacy Outcome Measure: mean spherical aberration of eyes treated with the VSS-Rx1 OPM treatment planning software compared to that of eyes treated with the commercial iDesign treatment planning software.|3 months|The analysis population was all evaluable eyes.||µm|Participants|Standard Deviation|Mean
653217|NCT01988402|Secondary|Serum Uric Acid Level|Blood test (serum) for uric acid level|day 28|||mg/dl||Standard Error|Mean
653218|NCT01988402|Secondary|Change in Physician Global Assessment of Gout Activity|Physician rated gout activity on a Likert scale 1-10.|Pateints are assessed at five time intervals over 28 days: days 1, 3-4, 10-15, 20-25, and 28||||||
653219|NCT01988402|Secondary|Change in Patient Rated Pain Over Time|Patient rated pain on a Likert pain score of 1-10|Pateints are assessed at five time intervals over 28 days: days 1, 3-4, 10-15, 20-25, and 28||||||
653220|NCT01988402|Primary|The Primary Outcome Unit of Measurement is Time (in Days) to Resolution of the Acute Gout Attack||1-28 Days|||days||Standard Deviation|Mean
653221|NCT01988129|Secondary|Change Firefighters’ and Families’ Job Satisfaction and Ability to Cope With Extended Work Hours|In developing the study detail with the department, it became apparent that it would be impractical to assess firefighters’ and families’ job satisfaction and ability to cope with extended work hours in a meaningful way. We therefore did not address this aim.|Baseline to 12 months|In developing the study detail with the department, it became apparent that it would be impractical to assess firefighters’ and families’ job satisfaction and ability to cope with extended work hours in a meaningful way. We therefore did not address this aim.|||||
653222|NCT01988129|Secondary|Change in Firefighters’ Health, as Determined by General Health Indices;|"The outcome measure was assessed in the intervention group only at the start and end of the program. There are no data for the control group and therefore they have not been added or reported as a separate study arm.
A higher health index is indicative of better health. We assessed general health with the question ‘ In general, would you say your health is Excellent/Very good/Good/Fair/Poor?’ and coded the answers from 5-1, respectively."|Baseline to 12 months|Within-subject pre- versus post-study. Only 97/100 individuals in the intervention group who completed the end-of-year survey responded to this question at both time points.||units on a scale||Standard Deviation|Mean
653223|NCT01988129|Secondary|Change in the Mean Alertness and Cognitive Performance of Firefighters - Sleeping While Stopped in Traffic|"A lower number of times reported sleeping while stopped in traffic is indicative of better alertness and cognitive performance.
The outcome measure was assessed in the intervention group only at the start and end of the program. There are no data for the control group and therefore they have not been added or reported as a separate study arm.
The analysis for the number of times individuals reported sleeping while stopped in traffic is limited to those individuals in the intervention stations who participated in the program, completed both the study start and 12-month follow-up survey."|Baseline to 12 months|Within-subject pre- versus post-study. Only 82/100 individuals in the intervention group who completed the end-of-year survey responded to this question at both time points.||Incidents/month||Standard Deviation|Mean
653224|NCT01988129|Secondary|Change in the Mean Alertness and Cognitive Performance of Firefighters - Sleeping While Driving|"A lower number of times reported sleeping while driving is indicative of better alertness and cognitive performance.
The outcome measure was assessed in the intervention group only at the start and end of the program. There are no data for the control group and therefore they have not been added or reported as a separate study arm.
The analysis for the number of times individuals reported being sleepy while driving is limited to those individuals in the intervention stations who participated in the program, completed both the study start and 12-month follow-up survey."|Baseline to 12 months|Within-subject pre- versus post-study. Only 81/100 individuals in the intervention group who completed the end-of-year survey responded to this question at both time points.||Incidents/month||Standard Deviation|Mean
653235|NCT01988012|Secondary|Immunogenicity: Percentage of Participants With Anti-tocilizumab Antibodies|Reported is the percentage of participants positive for anti-tocilizumab antibodies in the confirmatory anti-tocilizumab antibody assay, which followed an initial anti-tocilizumab screen. Participants, who withdrew from the study|Baseline, Week 24, Follow-up Week 32 and Early Withdrawal|The FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.||percentage of participants|||Number
653236|NCT01988012|Secondary|Percentage of Participants Who Required Dose Modifications or Discontinued Study Due to AEs||Up to Week 24|The FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab.||percentage of participants|||Number
653225|NCT01988129|Other Pre-specified|Number of Participants With Sleep Disorders According to Voluntary Sleep Disorders Screening Questionnaire|Firefighters were instructed to attend a mandatory 30-min education training presentation as operations allowed. Following the education, firefighters were invited and encouraged to complete a voluntary sleep disorders screening questionnaire. This questionnaire used validated, self-report screening tools for Obstructive Sleep Apnea (OSA), moderate to severe insomnia, restless legs syndrome and shift work disorder. All of the respondents who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a local American Academy of Sleep Medicine-certified, partnering sleep clinics if they chose to follow-up. Participants were also free to seek medical follow-up elsewhere. Telephone calls were made to all high risk participants to ensure that they were aware of the results, and to facilitate clinic scheduling. Participants were asked to provide voluntary medical records release consent for tracking diagnoses.|Baseline (Study start)|A total of 431 firefighters completed the sleep disorders screening survey including 416 from the intervention stations and 15 who were temporarily assigned to duty in the intervention stations on the day of the survey. We did not consider these 15 firefighters as a separate population.||participants|||Number
653226|NCT01988129|Primary|Firefighters’ Performance, as Determined by Response Time Over 12 Months|"A lower response time is indicative of better performance.
Following detailed review of departmental procedures and records, we determined that ‘turn-out time’ was already very rapid and not considered an accurate measure of firefighters’ performance by the department. Similarly, ‘clearance time’ (time from the start until the end of the event), which could last for many hours, was also not considered an appropriate measure of firefighter’ performance in relation to sleep and alertness given the multiple factors, many of which are not under the control of the firefighters, that could affect clearance times. We therefore did not address this aim."|12 months|Following review of departmental records, we determined that ‘turn-out time’ and ‘clearance time’ were not appropriate measures of firefighter’ performance in relation to sleep and alertness given the multiple factors that could affect them. We therefore did not address this aim.|||||
653227|NCT01988129|Secondary|Change in the Mean Alertness and Cognitive Performance of Firefighters - Sleeping on the Telephone|"A lower number of times reported sleeping on the telephone is indicative of better alertness and cognitive performance.
The outcome measure was assessed in the intervention group only at the start and end of the program. There are no data for the control group and therefore they have not been added or reported as a separate study arm.
The analysis for the number of times individuals reported sleeping on the telephone is limited to those individuals in the intervention stations who participated in the program, completed both the study start and 12-month follow-up survey."|Baseline to 12 months|Within-subject pre- versus post-study. Only 88/100 individuals in the intervention group who completed the end-of-year survey responded to this question at both time points.||Incidents/month||Standard Deviation|Mean
653228|NCT01988129|Secondary|Change in the Mean Alertness and Cognitive Performance of Firefighters - Sleepy During Meetings|"A lower number of times reported falling asleep during meetings is indicative of better alertness and cognitive performance.
The outcome measure was assessed in the intervention group only at the start and end of the program. There are no data for the control group and therefore they have not been added or reported as a separate study arm.
The analysis for the number of times individuals reported sleeping during meetings is limited to those individuals in the intervention stations who participated in the program, completed both the study start and 12-month follow-up survey."|Baseline to 12 months|Within-subject pre- versus post-study. Only 27/100 individuals in the intervention group who completed the end-of-year survey responded to this question at both time points.||Incidents/month||Standard Deviation|Mean
653229|NCT01988129|Secondary|Change in the Mean Total Sleep Time|"A higher total sleep time is indicative of better sleep. The outcome measure was assessed in the intervention group only at the start and end of the program. There are no data for the control group and therefore they have not been added or reported as a separate study arm.
The analysis for total sleep time is limited to those individuals in the intervention stations who participated in the program, completed both the study start and 12-month follow-up survey, and had at least 1 week of work scheduled in the 4 weeks prior to each survey."|Baseline to 12 months|Within-subject pre- versus post-study. Only 62/100 individuals in the intervention group who completed the end-of-year survey responded to this question at both time points.||Hours/week||Standard Deviation|Mean
653230|NCT01988129|Primary|Firefighter Safety, as Determined by On-the-job Injuries Over 12 Months|Fewer on-the-job injuries is indicative of better health. We assessed injuries cumulatively over 12 months. Injuries that triggered the filing of an official city government accident report as the result of following normal departmental procedures were included in this study.|12 months|||injury report/firefighter||Standard Deviation|Mean
653231|NCT01988129|Primary|Firefighter Safety, as Determined by Motor Vehicle Crashes Over 12 Months|Fewer motor vehicle crashes is indicative of better health. We assessed motor vehicle crashes cumulatively over 12 months. Accidents were counted as any incident that resulted in the filing and review of a departmental Fleet Accident Report.|12 months|||incidents/firefighter||Standard Deviation|Mean
653232|NCT01988129|Primary|Firefighters’ Health, as Determined by Number of ‘Sick’ Days Over 12 Months|We assessed 'sick days' cumulatively over 12 months in two ways from departmental payroll records; the number of 24-hour pay periods coded as 'sick' time per firefighter and the number of 24-hr pay periods coded as injury and disability per firefighter. Fewer sick days is indicative of better health.|12 months|||days/firefighter||Standard Deviation|Mean
653233|NCT01988012|Secondary|Immunogenicity: Change From Week 1 in Soluble Interleukin-6 Receptor (sIL-6R) Levels|A positive change from Week 1 indicates an increase in sIL-6R levels.|Week 1, Week 12, Week 24, Follow-up Week 32 and Early Withdrawal|The FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.||nanograms/milliliter (ng/mL)||Standard Deviation|Mean
653234|NCT01988012|Secondary|Immunogenicity: Tocilizumab Levels||Week 12, Week 24, Follow-up Week 32 and Early Withdrawal|The FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.||microgram/milliliter (mcg/mL)||Standard Deviation|Mean
653237|NCT01988012|Secondary|Percentage of Participants With Adverse Events (AEs) and AEs of Special Interest (AESIs)|An AE is any untoward medical occurrence in a participant administered a drug and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a drug, whether or not considered related to the drug. Preexisting conditions which worsen during a study are also considered as AEs. AESIs are AEs that occur in categories of special interest with regard to the benefit-risk profile and overall safety of a drug. The following nine categories of AESIs were identified for tocilizumab: 1) serious and/or medically significant infections, 2) myocardial infarction/acute coronary syndrome, 3) gastrointestinal perforations, 4) malignancies, 5) anaphylaxis/hypersensitivity reactions, 6) demyelinating disorders, 7) stroke, 8) serious and/or medically significant bleeding events, and 9) serious and/or medically significant hepatic events.|Up to Follow-up Week 32|The FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab.||percentage of participants|||Number
653238|NCT01988012|Primary|Total Scores on Hamilton Depression Rating Scale (HDRS) and Hamilton Anxiety Scale (HAS)|The HDRS is a clinician-administered depression assessment and consists of 17 items with a total score range from 0 to 54. A higher score indicates a worse outcome. HAS is a clinician-administered assessment to measure the severity of anxiety symptoms and consists of 14 items with a total score range from 0 to 56. A higher score indicates a worse outcome.|Baseline, Week 24|The FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.||units on a scale||Standard Deviation|Mean
653239|NCT01988012|Primary|Change From Baseline in Patient Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F)|The symptom-specific measure FACIT-F assesses chronic illness therapy with special emphasis on fatigue in the past 7 days and consists of 5 dimensions: 1) physical well- being, 2) social/family well-being, 3) emotional well-being, 4) functional well-being, and 5) additional concerns. Each of the questions is categorically answered using the scales 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much for a total possible FACIT-F score of 0 to 52. The figures are reversed during score calculations, so that higher score values indicate more favorable conditions. A positive change from baseline indicates an improvement.|Baseline, Week 24|The FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.||units on a scale||Standard Deviation|Mean
653240|NCT01988012|Primary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)|The HAQ-DI evaluates participant-reported quality of life using 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other common activities and 20 questions. Each category contains multiple questions, which were answered using a 4-point scale from 0 (without any difficulty) to 3 (unable to do). The overall index score was an average of the individual item responses and may range from 0 to 3, where higher scores indicate more difficulty in daily living activities. A negative change from baseline indicates an improvement.|Baseline, Week 24|The FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.||units on a scale||Standard Deviation|Mean
653241|NCT01988012|Primary|Change From Baseline in Patient Pain VAS|Patient Pain VAS represents the participant’s assessment of his/her current level of pain on a 100 mm horizontal VAS scale from 0 (no disease activity) to 100 (maximum disease activity). A negative change from baseline indicates an improvement.|Baseline, Week 24|The FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.||units on a scale||Standard Deviation|Mean
653242|NCT01988012|Primary|Change From Baseline in Patient Global Assessment of Disease Activity Visual Analog Scale (PGA VAS)|PGA VAS represents the participant’s overall assessment of their current disease activity on a 100 millimeter (mm) horizontal VAS scale from 0 (no disease activity) to 100 (maximum disease activity). A negative change from baseline indicates an improvement.|Baseline, Week 24|The FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.||units on a scale||Standard Deviation|Mean
653243|NCT01988012|Primary|Change From Baseline in Percentage of Participants on Tocilizumab Monotherapy|Participants were either on tocilizumab monotherapy or tocilizumab plus non-biologic disease modifying anti-rheumatic drugs (DMARDs). Reported here is the percentage of participants on tocilizumab monotherapy at baseline and the change from baseline at Week 24. A positive change from baseline at Week 24 indicates the percentage of participants, who discontinued DMARDs during the study.|Baseline, Week 24|The FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab.||percentage of participants|||Number
653244|NCT01988012|Primary|Change From Baseline in TJC and SJC|The number of tender joints (based on 68 joints) and swollen joints (based on 66 joints) were counted at each visit. TJC was determined by identifying the joints that were painful under pressure or to passive motion; no tenderness =0, tenderness =1. SJC was determined by identifying swelling; no swelling =0, swelling =1. A negative change from baseline indicates an improvement.|Baseline, Week 24|The FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.||joint count||Standard Deviation|Mean
653245|NCT01988012|Primary|Percentage of Participants With Good to Moderate European League Against Rheumatism (EULAR) Response|Response was determined using EULAR criteria based upon DAS28 absolute scores at the assessment visit and the DAS28 reduction from the reference visit. Participants with a score lesser than or equal to (</=) 3.2 and reduction of greater than (>) 1.2 points were assessed as having a 'good' response. Participants with a score >3.2 with reduction of >1.2 points, or a score <=5.1 with reduction of >0.6 to <=1.2 points, were assessed as having a 'moderate' response. Participants with a score >5.1 with reduction of >0.6 to <=1.2 points, or any score with reduction <=0.6 points, were assessed as non-responders with response recorded as 'none.'|Week 24|The analysis population included those participants from the FAS for whom evaluable data for this outcome measure were available. The FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab.||percentage of participants|||Number
654041|NCT01971086|Secondary|Subjective Assessment of the Physicians of Overall Treatment Tolerability at the Closing/Final Visit.|The tolerability of the treatment was rated by the physician at the closing/final visit for every patient.|up to day 11|Patients from TS.||participants|||Number
653246|NCT01988012|Primary|Percentage of Participants Achieving 20%, 50% and 70% Improvement in American College of Rheumatology (ACR) Response Scores (ACR20, ACR50 and ACR70)|An ACR20 response requires at least 20% improvement compared to baseline in SJC (based on 66 joints) and TJC (based on 68 joints) as well as at least 20% improvement in 3 of the following 5 assessments: 1) PGA pain VAS, 2) PGA VAS; 3) physician’s global assessment of disease activity VAS, 4) Health Assessment Questionnaire-Disability Index (HAQ-DI) with 20 questions consisting of 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do; and 5) CRP in mg/L or ESR in mm/hr. ACR50 and ACR70 responses are defined in a similar way except that they required a 50% and 70% improvement from baseline, respectively. VAS assessments involved a 10 cm horizontal scale from 0 (no disease activity) to 10 (maximum disease activity).|Week 24|The analysis population included those participants from the FAS for whom evaluable data for this outcome measure were available. The FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab.||percentage of participants|||Number
653247|NCT01988012|Primary|Change From Baseline in Disease Activity Score 28-Erythrocyte-Sedimentation Rate (DAS28-ESR)|The DAS28-ESR score is a measure of the patient’s disease activity calculated using the tender joint count on 28 joints (TJC28), swollen joint count on 28 joints (SJC28), patient’s global assessment (PGA) of disease activity based on visual analog scale (VAS) and the erythrocyte sedimentation rate (ESR) in millimeter/hour (mm/hr). VAS assessments involved a 10 cm horizontal scale from 0 (no disease activity) to 10 (maximum disease activity). Total possible score ranged from 0 to 10. Higher scores represent higher disease activity. A negative change from baseline indicates an improvement.|Baseline, Week 24|The FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.||units on a scale||Standard Deviation|Mean
653248|NCT01988012|Primary|Change From Baseline in SDAI|Simplified Disease Activity Index (SDAI) was an index for measuring disease activity in RA and had a good correlation with the DAS28. The index was calculated using the following formula: SDAI: SJC28 + TJC28 + PGA (10 cm VAS) + PhGA (10 cm VAS + C-Reactive Protein (CRP) in mg/L. VAS assessments involved a 10 cm horizontal scale from 0 (no disease activity) to 10 (maximum disease activity). Scores ranged from 0 to 86, with higher scores also indicating increased disease activity. A negative change from baseline indicates an improvement.|Baseline, Week 24|The FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.||units on a scale||Standard Deviation|Mean
653249|NCT01988012|Primary|Percentage of Participants With Simplified Disease Activity Index (SDAI) Remission and SDAI Low Disease Activity|Simplified Disease Activity Index (SDAI) was an index for measuring disease activity in RA and had a good correlation with the DAS28. The index was calculated using the following formula: SDAI: SJC28 + TJC28 + PGA (10 cm VAS) + PhGA (10 cm VAS + C-Reactive Protein (CRP) in milligram/liter (mg/L). VAS assessments involved a 10 cm horizontal scale from 0 (no disease activity) to 10 (maximum disease activity). Scores ranged from 0 to 86, with higher scores also indicating increased disease activity. An SDAI score of ≤ 3.3 represents clinical remission, a score of ≤ 11.0 represents low disease activity.|Week 24|The analysis population included those participants from the FAS for whom evaluable data for this outcome measure were available. The FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab.||percentage of participants|||Number
653250|NCT01988012|Primary|Change From Baseline in CDAI|Clinical Disease Activity Index (CDAI) is an index for measuring disease activity in rheumatoid arthritis (RA). The index was calculated using the following formula: CDAI = number of swollen joints using the 28-joint count (SJC28) + number of tender joints using the 28-joint count (TJC28) + patient global assessment of disease (PGA) based on 10 centimeter [cm] Visual Analog Scale [VAS] + physician global assessment of disease (PhGA) based on 10 cm VAS. VAS assessments involved a 10 cm horizontal scale from 0 (no disease activity) to 10 (maximum disease activity). Total CDAI scores ranged from 0 to 76, with higher scores indicating increased disease activity. A negative change from baseline indicates an improvement.|Baseline, Week 24|The FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.||units on a scale||Standard Deviation|Mean
653251|NCT01988012|Primary|Percentage of Participants With Clinical Disease Activity Index (CDAI) Remission and CDAI Low Disease Activity|Clinical Disease Activity Index (CDAI) is an index for measuring disease activity in rheumatoid arthritis (RA). The index was calculated using the following formula: CDAI = number of swollen joints using the 28-joint count (SJC28) + number of tender joints using the 28-joint count (TJC28) + patient global assessment of disease (PGA) based on 10 centimeter [cm] Visual Analog Scale [VAS] + physician global assessment of disease (PhGA) based on 10 cm VAS. VAS assessments involved a 10 cm horizontal scale from 0 (no disease activity) to 10 (maximum disease activity). Total CDAI scores ranged from 0 to 76, with higher scores indicating increased disease activity. Remission is defined as CDAI ≤2.8 and Low Disease Activity (LDA) is defined as 2.8< CDAI ≤10.|Week 24|The analysis population included those participants from the full analysis set (FAS) for whom evaluable data for this outcome measure were available. The FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab.||percentage of participants|||Number
653252|NCT01987986|Other Pre-specified|Subject Global Assessment of Aesthetic Improvement (C-GAIS)|Subjects's assessment of aesthetic improvement (C-GAIS) scores ranged from 3 to -1 as follows: 3 (very much improved), 2 (much improved), 1 (improved), 0 (no change), -1 (worse).|Day 73|All subjects who received at least one injection of study medication and had at least one post injection efficacy measurement.||units on a scale||Standard Deviation|Mean
653253|NCT01987986|Other Pre-specified|Subject Global Assessment Cellulite (SGA-C)|Subjects assessed their cellulite based on a 5-point scale from -1 (slightly worse), 0 (same), 1 (slightly improved), 2 (moderately improved), to 3 (much improved) on Day 73|Day 73|All subjects who at least one injection of study drug and had at least one post-injection efficacy measurement.||units on a scale||Standard Deviation|Mean
653254|NCT01987986|Other Pre-specified|Subject Satisfaction With Treatment Assessment (SCTA)|Subjects rated their treatment satisfaction at the Day 73 visit on a 5-point scale ranging from -2 (very dissatisfied) to +2 (very satisfied)|Day 73|All subjects who received at least one injection of study drug and had at least one post -injection efficacy measurement.||units on a scale||Standard Deviation|Mean
670449|NCT01700387|Primary|Subject's Mental Efficiency Workload Test (MEWT) Overall Performance Index (PI) Score at Visits 2-6 to Measure Cognitive Efficiency||12 Months||||||
653255|NCT01987986|Other Pre-specified|Subject-reported Cellulite Impact Scale (SR-CIS)-Change From Baseline|"Subjects were asked to answer 6 exploratory questions regarding the appearance of their cellulite on a scale of 0 to 10 with 0 representing not at all and 10 representing extremely. A SR-CIS total score was derived from these 6 questions with values varying from 0 (No negative impact) to 60 (Extreme negative impact). Change from baseline is Day 73 value minus baseline value; negative change reflects an improvement."|Baseline, Day 73|All subjects who received at least one injection and who had at least one post-injection efficacy measurement.||units on a scale||Standard Deviation|Mean
653256|NCT01987986|Other Pre-specified|Subject Global Bother Assessment (SGBA)- Change From Baseline|Subjects rated their cellulite on a scale from 0 (not at all bothered) to 4 (extremely bothered). Change from baseline is Day 73 study visit value minus baseline value; negative change reflects an improvement in the amount the subject was bothered by cellulite; positive change reflects a worsening in the amount the subject is bothered by cellulite.|Baseline, Day 73|All subjects who received at least one injection of study drug and had at least one post-injection efficacy measurement.||units on a scale||Standard Deviation|Mean
653257|NCT01987986|Other Pre-specified|Subject Cellulite Severity Item (CSI)-Change From Baseline|CSI scores ranged from 0 (no cellulite present), 1 (very mild), 2 (mild), 3 (moderate), 4 (severe) to 5 (very severe). Change is Day 73 study visit rating minus baseline rating; negative values indicate a lessening in cellulite severity.|Baseline, Day 73|All subjects who received at least one injection of study drug and had at least one post-injection efficacy measurement.||units on a scale||Standard Deviation|Mean
653258|NCT01987986|Other Pre-specified|Investigator Cellulite Severity Score (CSS) Total Score- Change From Baseline|The CSS is a photonumeric scale that was used to evaluate 5 morphologic features of cellulite; (A) number of evident depressions, (B) depth of depressions, (C) morphological appearance of skin surface alterations, (D) laxity, flaccidity or sagging of skin, and (E) current classification scale based on medical literature including Nuernberger and Mueller. The severity of each feature is rated on a scale from 0 (none) to 3 (most severe). The CSS total score is the sum of the 5 cellulite features (range: 0 to 15, with higher scores corresponding to more severe cellulite). Change is Day 73 study visit rating minus baseline rating; negative values indicate improvement in cellulite.|Baseline, Day 73|All subjects who received at least one injection of study drug and had at least one post-injection efficacy measurement.||units on a scale||Standard Deviation|Mean
653259|NCT01987986|Primary|Investigator Global Assessment of Aesthetic Improvement|Investigators assessment of aesthetic improvement (I-GAIS) scores ranged from 3 to -1 as follows: 3 (very much improved), 2 (much improved), 1 (improved), 0 (no change), -1 (worse).|Baseline, Day 73|All subjects who received at least one injection of study drug and had at least one post-injection efficacy measurement.||units on a scale||Standard Deviation|Mean
653260|NCT01987960|Secondary|Global Clinical Impression Severity of Illness (CGI-S) Score|Clinical Global Impression - Severity of Illness (CGI-S) The CGI-S provides the clinician’s impression of the patient’s current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient’s current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients).|Period 2: Baseline to Week 12 (of randomized period)|Due to the low number of enrolled patients eligible for randomization and the sponsor's early termination of the study, the data presented are descriptive i.e. the primary and key secondary efficacy analyses were not done.||Score||Standard Deviation|Mean
653261|NCT01987960|Primary|PTSD Symptoms Using CAPS-2 Total Score|Clinician-Administered PTSD Scale Part 2 (CAPS-2): 17 items in criteria B, C and D (Corresponding to CAPS-2) will be administered to provide a total score. They are rated on a 5 point scale for frequency from 0 (never or none) to 4 (daily or almost every day), and intensity from 0 (none) to 4 (extreme). The sum of the 17 items gives a toal score ranging from 0 to 136, with a higher score indicating greater symptom severity.|Period 2: Baseline to Week 12 (of randomized period)|Due to the low number of enrolled patients eligible for randomization and the sponsor's early termination of the study, the data presented are descriptive i.e. the primary and key secondary efficacy analyses were not done||Score||Standard Deviation|Mean
670508|NCT01699789|Secondary|Hospitalization for Behavioral Health|Any hospitalization for alcohol, drug, mental health, %|6 months follow-up|||percentage of participants||95% Confidence Interval|Number
653336|NCT01987453|Secondary|Percentage of Participants With Sustained Virologic Response (SVR) at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study treatment, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set||Percentage of participants|||Number
670533|NCT01699373|Secondary|Time Taken to Perform Spinal Anaesthesia||During procedure||||||
653301|NCT01987765|Primary|Change From Baseline in Eye Symptoms Total Score on a 4-Point Scale|Itchiness, conjunctival hyperaemia (redness), lacrimation (tearing), and foreign body sensation were each evaluated on a 4-point scale ranging from 0 (best) to 3 (worst). The eye symptom total score is the sum of the individual symptom scores and ranges from 0 (best) to 12 (worst). A negative number change from baseline indicates an improvement.|Baseline, 2 Weeks|Efficacy Assessment Population: included all patients in the Safety Assessment Population whose data was available for analysis.||Scores on a Scale||Standard Deviation|Mean
653302|NCT01987765|Primary|Percentage of Patients Reporting Adverse Events|An adverse event is any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.|Up to 10 Months|Safety Assessment Population: included all patients who completed the study.||Percentage of Patients|||Number
653303|NCT01987752|Primary|Percentage of Participants With Overall Improvement From Baseline in Intraocular Pressure (IOP)|IOP is a measurement of the fluid pressure inside the eye. The study doctor classified the overall improvement of the IOP change from Baseline into 3 categories: Improvement (effective), No Change or Exacerbation (ineffective). The percentage of participants with Improvement is reported.|Baseline, Week 4|Efficacy Population included all participants who received study drug for > 4 weeks and had overall assessment data available.||Percentage of participants|||Number
653304|NCT01987752|Primary|Percentage of Participants Reporting Adverse Events|An adverse event was any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.|Up to 2.6 Years|Safety Population included all participants who received study drug.||Percentage of participants|||Number
653305|NCT01987583|Primary|Diastolic Blood Pressure After 4 Weeks||1 month|||mmHg||Standard Deviation|Mean
653306|NCT01987583|Secondary|Incidence of Wet Cupping Side Effects in Intervention Group|"Immediate side effects of wet cupping will be assessed through a checklist on the after each cupping session.
Delayed side effects of wet cupping will be assessed through another checklist after 1 month of the final hijama session."|1 month||||||
653307|NCT01987583|Primary|Systolic Blood Pressure After 4 Weeks||1 month|||mmHg||Standard Deviation|Mean
653308|NCT01987557|Secondary|Static Posturography (Balance/Postural Control)|A Balance SD system from BIODEX (Shirley, NY) will be used to assess postural control. Changes from pre to post are what is being examined.|pre test occurs within the week prior to the start of the treadmill training program. Post testing will occur during the week immediately following the 6 week treadmill training program.||||||
653309|NCT01987557|Secondary|Spatiotemporal Aspects of Gait|"Participants will walk on a pressure sensitive GAITRite carpet (Sparta, NJ), at both comfortable and fast paced walking speeds. Changes in gait characteristics from pre to post are what is being examined.
Quantitative measures of gait such as step time, step length, walking velocity, and others will be used in the analysis.
Spotters are always present to ensure safety during this assessment."|pre test occurs within the week prior to the start of the treadmill training program. Post testing will occur during the week immediately following the 6 week treadmill training program.||||||
653310|NCT01987557|Primary|Motor Section of the Unified Parkinson's Disease Rating Scale (UPDRS-III)|"A measure of the motor symptom severity within Parkinsons. UPDRS III is a qualitative assessment performed by a trained clinician. Specifically, a change in UPDRS III from pre to post is the main outcome measure.
The UPDRS-III score is a summation of 27 tasks that are scored from 0-4. 0 meaning no impairment, and 4 representing extreme impairment, inability to complete task. Possible scores on the UPDRS-III range from 0 (no impairment) to 108 (extreme impairment)."|Pre assessments are conducted in the week prior to the treadmill program. Post are conducted during the week immediately following the program. Changes after the 6 week treadmill program are being examined|||units on a scale (0-4)||Standard Deviation|Mean
653311|NCT01987479|Secondary|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score|The FACIT-F score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participants fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score).|Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and early withdrawal (up to Week 24)|FAS population. Here, “n” = participants who were evaluable at specified timepoint.||units on a scale||Standard Deviation|Mean
653312|NCT01987479|Secondary|Percentage of Participants Compliant to Tocilizumab Treatment as Measured by Diary Cards and Return Records|A diary card was provided to participants to record home injections. Participants were asked to return all empty drug supply boxes, unused pre-filled syringe, and diary cards to the clinic at each visit as a measure of drug accountability and participant compliance. A participant was considered compliant if the participant correctly administered all scheduled doses of SC tocilizumab during the assessment period.|Weeks 2, 4, 8, 12, 16, 20, 24, and early withdrawal (up to Week 24)|FAS population. “n” = participants who were evaluable at specified timepoint.||percentage of participants|||Number
653313|NCT01987479|Secondary|Health Assessment Questionnaire-Disability Index (HAQ-DI) Score|The HAQ-DI questionnaire measures functional status (disability) and health-related quality of life. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common activities over past week. Each question is evaluated according to the degree of severity on a 4-point scale. Total score for HAQ-DI was the average of all questions and ranges from 0 = without any difficulty to 3 = unable to do.|Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and early withdrawal (up to Week 24)|FAS population. Here, “n” = participants who were evaluable at specified timepoint.||units on a scale||Standard Deviation|Mean
653314|NCT01987479|Secondary|Patient Pain VAS Scores|This assessment represents the participant’s assessment of his/her current level of pain on a 100 mm horizontal VAS where 0 mm= no pain to 100 mm= unbearable pain.|Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and Early withdrawal (up to Week 24)|FAS population. Here, “n” = participants who were evaluable at specified timepoint.||mm||Standard Deviation|Mean
653315|NCT01987479|Secondary|Patient Global Assessment of Disease Activity VAS Scores|Patient global assessment of disease activity was measured on a 0 to 100 mm horizontal VAS where 0 mm=no disease activity and 100 mm=maximum disease activity.|Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and Early withdrawal (up to Week 24)|FAS population. Here, “n” = participants who were evaluable at specified timepoint.||mm||Standard Deviation|Mean
653316|NCT01987479|Secondary|Serum Levels of Soluble Interleukin-6 Receptors (sIL-6Rs)||Baseline, Weeks 12 and 24, Early Withdrawal (up to Week 24), Follow-up Visit (8 weeks after last dose of tocilizumab, up to 32 weeks)|FAS population. “n” = participants who were evaluable at specified timepoint.||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
653317|NCT01987479|Secondary|Serum Levels of Tocilizumab||Baseline, Weeks 12 and 24, Early Withdrawal (up to Week 24), Follow-up Visit (8 weeks after last dose of tocilizumab, up to 32 weeks)|FAS population. “n” = participants who were evaluable at specified timepoint.||micrograms per milliliter (mcg/mL)||Standard Deviation|Mean
653318|NCT01987479|Secondary|Percentage of Participants With Anti-Tocilizumab Antibodies||Baseline, Weeks 12 and 24, early withdrawal (up to Week 24), follow-up visit (8 weeks after last dose of tocilizumab, up to 32 weeks)|FAS population. Here, “n” = participants who were evaluable at specified timepoint.||percentage of participants|||Number
653319|NCT01987479|Secondary|Time to Discontinuation or First Dose Reduction of Corticosteroids or NSAIDs|Time to discontinuation or first dose reduction of corticosteroids or NSAIDs (weeks) = (Date of the first dose reduction or end date of corticosteroids or NSAIDs treatment - date of first drug intake of this study) + 1. Time to discontinuation or first dose reduction was based on the first occurring event (corticosteroid discontinuation or corticosteroid first dose reduction or NSAIDs discontinuation or NSAIDs first dose reduction, whichever occurred first).|Baseline up to Week 32|FAS population||weeks||95% Confidence Interval|Median
653320|NCT01987479|Secondary|Percentage of Participants With Corticosteroid Dose Reductions or Discontinuation Categorized by Reasons|Results are reported for percentage of participants who had corticosteroid dose reductions or discontinuation by reasons for dose reductions or discontinuation (unknown reasons, safety reasons, other reasons, lack of efficacy, and discomfort).|From Week 16 and before Week 20; From Week 20 and before Week 24|FAS population||percentage of participants|||Number
653321|NCT01987479|Secondary|Percentage of Participants With Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Dose Reductions or Discontinuation Categorized by Reasons|Results are reported for percentage of participants who had NSAIDs dose reductions or discontinuation by reasons for dose reductions or discontinuation (unknown reasons, safety reasons, other reasons, lack of efficacy, and discomfort).|From Week 16 and before Week 20; From Week 20 and before Week 24|FAS population||percentage of participants|||Number
653322|NCT01987479|Secondary|Change From Baseline in Total SJC at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal|Number of swollen joints was determined by examination of 28 joints for SJC28 and 66 joints for SJC66 and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1; total was calculated by adding all the joints for a maximum score of 28 for a SJC28 and 66 for a SJC66. A reduction in number of swollen joints compared to baseline indicates improvement.|Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24)|FAS population. Here, “n” = participants who were evaluable at specified timepoint.||swollen joints||Standard Deviation|Mean
653323|NCT01987479|Secondary|Change From Baseline in Total TJC at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal|Number of tender joints was determined by examining 28 joints for TJC28 and 68 joints for TJC68, and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1; total was calculated by adding all the joints for a maximum score of 28 for a TJC28 and 68 for a TJC68. A reduction in number of tender joints compared to baseline indicates improvement.|Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24)|FAS population. Here, “n” = participants who were evaluable at specified timepoint.||tender joints||Standard Deviation|Mean
653324|NCT01987479|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 8, 16, 20, 24, and Early Withdrawal|The CDAI is the numerical sum of four outcome parameters: TJC and SJC based on a 28-joint assessment, patient and physician’s global assessment of disease activity assessed on 0-10 cm VAS (0 cm= no disease activity and 10 cm= worst disease activity). CDAI total score = 0-76. CDAI <= 2.8 indicates clinical remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high (or severe) disease activity.|Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24)|FAS population. Here, “n” = participants who were evaluable at specified timepoint.||units on a scale||Standard Deviation|Mean
653333|NCT01987453|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as:
On-treatment virologic failure:
Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)
Virologic relapse:
Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit confirmed with 2 consecutive values or last available posttreatment measurement"|Up to posttreatment Week 24|Full Analysis Set||Percentage of participants|||Number
653334|NCT01987453|Secondary|Change in HCV RNA From Baseline||Baseline to Week 8|Full Analysis Set||log10 IU/mL||Standard Deviation|Mean
653325|NCT01987479|Secondary|Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal|The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, patient and physician global assessment of disease activity assessed on 0-10 centimeter (cm) VAS (0 cm= no disease activity and 10 cm= worst disease activity), and CRP in milligrams per liter (mg/L). SDAI total score = 0-86. SDAI <=3.3 indicates clinical remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high (or severe) disease activity .|Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24)|FAS population. Here, “Overall Number of Participants Analyzed” = participants who were evaluable for this outcome. “n” = participants who were evaluable at specified timepoint.||units on a scale||Standard Deviation|Mean
653326|NCT01987479|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR|DAS28-ESR was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (VAS: 0 mm=no disease activity to 100 mm=maximum disease activity). DAS28-ESR scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. The DAS28-ESR based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders had a change from baseline >1.2 with a DAS28 score ≤3.2; moderate responders had a change from baseline >1.2 with a DAS28 score >3.2 or a change from baseline >0.6 to ≤1.2 with a DAS28 score ≤5.1. Participants with change from baseline >0.6 to ≤1.2 with a DAS28 score >5.1, or any score with change from baseline ≤0.6, were assessed as non-responders.|Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24)|FAS population. “n” = participants who were evaluable at specified timepoint.||percentage of participants|||Number
653327|NCT01987479|Secondary|Percentage of Participants Achieving an ACR90 Response|A participant had an ACR90 response if there was at least a 90% improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity [VAS: 0 mm=no disease activity to 100 mm=maximum disease activity]; 2) Patient's Global Assessment of Disease Activity [VAS: 0 mm=no disease activity to 100 mm=maximum disease activity]; 3) Patient's Assessment of Pain [VAS: 0 mm=no pain to 100 mm=unbearable pain]; 4) Health Assessment Questionnaire [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do] and 5) an acute-phase reactant (either CRP or ESR).|Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24)|FAS population. “n” = participants who were evaluable at specified timepoint.||percentage of participants|||Number
653328|NCT01987479|Secondary|Percentage of Participants Achieving an ACR70 Response|A participant had an ACR70 response if there was at least a 70% improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity [VAS: 0 mm=no disease activity to 100 mm=maximum disease activity]; 2) Patient's Global Assessment of Disease Activity [VAS: 0 mm=no disease activity to 100 mm=maximum disease activity]; 3) Patient's Assessment of Pain [VAS: 0 mm=no pain to 100 mm=unbearable pain]; 4) Health Assessment Questionnaire [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do] and 5) an acute-phase reactant (either CRP or ESR).|Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24)|FAS population. “n” = participants who were evaluable at specified timepoint.||percentage of participants|||Number
653329|NCT01987479|Secondary|Percentage of Participants Achieving an ACR50 Response|A participant had an ACR50 response if there was at least a 50% improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity [VAS: 0 mm=no disease activity to 100 mm=maximum disease activity]; 2) Patient's Global Assessment of Disease Activity [VAS: 0 mm=no disease activity to 100 mm=maximum disease activity]; 3) Patient's Assessment of Pain [VAS: 0 mm=no pain to 100 mm=unbearable pain]; 4) Health Assessment Questionnaire [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do] and 5) an acute-phase reactant (either CRP or ESR).|Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24)|FAS population. “n” = participants who were evaluable at specified timepoint.||percentage of participants|||Number
653330|NCT01987479|Secondary|Percentage of Participants Achieving an American College of Rheumatology Criteria 20 (ACR20) Response|A participant had an ACR20 response if there was at least a 20 percent (%) improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity [VAS: 0 mm=no disease activity to 100 mm=maximum disease activity]; 2) Patient's Global Assessment of Disease Activity [VAS: 0 mm=no disease activity to 100 mm=maximum disease activity]; 3) Patient's Assessment of Pain [VAS: 0 mm=no pain to 100 mm=unbearable pain]; 4) Health Assessment Questionnaire [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do] and 5) an acute-phase reactant (either C-reactive protein [CRP] or ESR).|Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24)|FAS population. “n” = participants who were evaluable at specified timepoint.||percentage of participants|||Number
653331|NCT01987479|Secondary|Change From Baseline in Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR) Score at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal|DAS28 was calculated from swollen joint count (SJC) and tender joint count (TJC) using 28 joints count, erythrocyte sedimentation rate (ESR; millimeters per hour [mm/hour]), and patient’s global assessment of disease activity (measured on a 0 to 100 mm Visual Analog Scale [VAS] where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR less than or equal to (≤) 3.2 implied low disease activity and greater than (>) 3.2 to 5.1 implied moderate to high disease activity, and DAS28-ESR less than (<) 2.6 implied clinical remission.|Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24)|FAS population. Here, “n” = participants who were evaluable at the specified timepoint.||units on a scale||Standard Deviation|Mean
653335|NCT01987453|Secondary|Percentage of Participants With HCV RNA < LLOQ While on Treatment||Baseline to Week 24|Full Analysis Set||Percentage of participants|||Number
653338|NCT01987453|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study treatment.|Post-treatment Week 12|Full Analysis Set: participants enrolled into the study and received at least 1 dose of study drug||Percentage of participants|||Number
653339|NCT01987349|Other Pre-specified|Lymphocyte Response to Influenza Immunization|Compare lymphocyte responses at Days 6-14 and the lymphocyte and serology responses at Day 28 post-immunization following annual administration of the influenza vaccines|Day 6-28 post-immunization||||||
653340|NCT01987349|Secondary|Number of Participants With Related Adverse Events||Day 0 to 28 post-immunization|||Participants|||Count of Participants
653341|NCT01987349|Primary|Number of Participants From Each Arm Who Received Influenza Vaccine Vaccine||Day 0 to 28|||Participants|||Count of Participants
653342|NCT01987232|Other Pre-specified|Duration of Response|"Duration of response (DOR) was calculated for participants who achieved a confirmed CR or PR. defined as the time from first evidence of confirmed PR/CR to disease progression or death due to any cause. Median DOR was calculated using Kaplan-Meier methods. Participants with no baseline disease assessments, who started a new anticancer therapy before documentation of PD or death, with death or PD immediately after more than 1 consecutively missed disease assessment visit or alive without documentation of PD before the data cutoff date were censored.
DOR was originally specified as a secondary endpoint for the phase 2 portion of the study. Since phase 2 did not proceed, DOR was analyzed in phase 1b participants on an exploratory basis."|From first dose of study drug until the end of treatment; median duration of treatment was 16 weeks.|Participants with a confirmed response of PR or CR.||months||95% Confidence Interval|Median
653343|NCT01987232|Other Pre-specified|Overall Response Rate|"The overall response rate (ORR) was defined as the percentage of participants for whom the best overall confirmed response was either complete response (CR) or partial response (PR) assessed by the investigator according to RECIST v1.1 criteria.
CR: Disappearance of all target and non-target lesions, no new lesions and normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.
PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters, or, the disappearance of all target lesions and persistence of one or more non-target lesion(s) and/or maintenance of tumor marker levels above normal limits."|From first dose of study drug until the end of treatment; median duration of treatment was 16 weeks.|All participants who received at least 1 dose of study treatment.||percentage of participants||95% Confidence Interval|Number
653344|NCT01987232|Other Pre-specified|Progression-free Survival|"Progression-free survival (PFS) was specified as a primary endpoint for the phase 2 portion of the study. Since phase 2 did not proceed PFS was analyzed in phase 1b participants on an exploratory basis. PFS was defined as the time from the start of treatment to documented disease progression or death due to any cause, whichever occurred first. Disease progression was determined by the investigator according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, defined as at least a 20% increase in the size of target lesions (absolute increase ≥ 5 mm), unequivocal progression of existing non-target lesions, or any new lesions.
Median PFS was calculated using Kaplan-Meier methods. Participants with no baseline disease assessments, who started a new anticancer therapy before documentation of PD or death, with death or PD immediately after more than 1 consecutively missed disease assessment visit or alive without documentation of PD before the data cutoff date were censored."|From first dose of study drug until the end of treatment; median duration of treatment was 16 weeks.|All participants who received at least 1 dose of study treatment.||months||95% Confidence Interval|Median
653345|NCT01987232|Secondary|Area Under Plasma Concentration-Time Curve - Phase 2|Pharmacokinetic (PK) analyses were specified as secondary endpoints for the phase 2 portion of the study; since phase 2 was not conducted, PK analyses were not performed.|Cycle 1 Day 2|Phase 2 participants|||||
653346|NCT01987232|Secondary|Time of Maximum Plasma Concentration - Phase 2|Pharmacokinetic (PK) analyses were specified as secondary endpoints for the phase 2 portion of the study; since phase 2 was not conducted, PK analyses were not performed.|Cycle 1 Day 2|Phase 2 participants|||||
653347|NCT01987232|Secondary|Maximum Plasma Concentration - Phase 2|Pharmacokinetic (PK) analyses were specified as secondary endpoints for the phase 2 portion of the study; since phase 2 was not conducted, PK analyses were not performed.|Cycle 1 Day 2|Phase 2 participants|||||
653348|NCT01987232|Secondary|Overall Survival (OS) - Phase 2|Overall Survival (OS) is defined as the time from randomization to the date of death. Overall survival was a specified secondary endpoint for the phase 2 portion of the study; since phase 2was not conducted, OS was not analyzed.|30 months|Participants enrolled in phase 2|||||
653349|NCT01987232|Secondary|Number of Participants With Adverse Events (AEs)|"The severity of each adverse event was assessed using the NCI-CTCAE Version 4.03 according to the following:
Grade 1 - Mild: Asymptomatic or mild symptoms; intervention not indicated
Grade 2 – Moderate: Minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL)
Grade 3 – Severe: Medically significant but not life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL
Grade 4 – Life-threatening
Grade 5 – Fatal.
A serious AE is an AE that met one or more of the following criteria:
Death
Life-threatening
Required inpatient hospitalization or prolongation of an existing hospitalization
Resulted in persistent or significant disability/incapacity
A congenital anomaly/birth defect
Important medical events that required medical or surgical intervention to prevent one of the outcomes above."|From first day of any study treatment (i.e., carfilzomib, carboplatin, or etoposide) up to 30 days after the last day of study treatment. The median overall duration of treatment was 16 weeks.|All participants who received at least 1 dose of study treatment.||Participants|||Count of Participants
653370|NCT01986855|Secondary|Change From Baseline in FPG at Week 26 - Baseline eGFR ≥45 to <60 mL/Min/1.73m^2 Stratum - Excluding Rescue Approach|This change from baseline reflects the Week 26 FPG minus the Week 0 FPG. Excluding rescue approach data analysis excluded all data following the initiation of rescue therapy at any time point, in order to avoid the confounding influence of the rescue therapy.|Baseline and Week 26|The analysis population included all randomized participants with a Baseline eGFR ≥45 to <60 mL/min/1.73m^2 and who took at least 1 dose of study treatment and had at least 1 assessment at or after baseline for the change from baseline at Week 26 FPG endpoint.||mg/dL||95% Confidence Interval|Least Squares Mean
670534|NCT01699373|Primary|Success Rate of First-attempt of Spinal Anaesthesia||During procedure|||participants|||Number
653350|NCT01987232|Primary|Number of Participants With Dose-limiting Toxicities|"The maximum tolerated dose (MTD) was defined as the highest dose level at which < 33% of participants experienced a dose-limiting toxicity (DLT) during the first 21-day cycle. Dose-limiting toxicities were evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03. A DLT was defined as:
A grade 3 or greater non-hematologic toxicity that was assessed as related to carfilzomib by the investigator except in the case of neuropathy. A grade 2 or higher neuropathy with pain was considered a DLT.
Grade 4 neutropenia: absolute neutrophil count (ANC) < 500 mm³, lasting ≥ 7 days despite granulocyte colony stimulating factor support, or any febrile (temperature > 38.3°C) neutropenia (ANC < 1000 mm³).
Thrombocytopenia of any grade associated with clinically significant bleeding or platelet/blood transfusion
Grade 4 fatigue lasting ≥ 7 days
Grade 3 nausea, vomiting or diarrhea lasting ≥ 7 days."|First 21-day Cycle|All participants who received at least 1 dose of study treatment.||Participants|||Count of Participants
653351|NCT01987219|Secondary|Change in Forced Expiratory Flow Between 25-75% (FEF25-75)|FEF25-75 is measured in liters of air per second at 25-75%|pre and 30 minutes post intervention|||percentage change from baseline||Standard Deviation|Mean
653352|NCT01987219|Secondary|Change in Forced Expiratory Volume (FEV) From Baseline|Forced expiratory volume is measured in liters of air per second. FEV was measured during the first second of exhalation.|Pre and 30 post study drug admistration|||percentage change from baseline||Standard Deviation|Mean
653353|NCT01987219|Primary|Change in Respiratory Function (Airway Resistance at 5 Hz) From Baseline|The percentage change in respiratory function from baseline is measured in percentage change in Resistance, kPa/(L/s).|Pre and 30 minutes post study drug administration|||percentage change from baseline||Standard Deviation|Mean
653354|NCT01987219|Primary|Change From Baseline of Forced Vital Capacity|FVC is a measure of the amount of air exhaled, and is measured in liters of air per second. The percentage in the change in the amount of air exhaled from baseline, measured in liters of air per second. Increase in the percentage of air exhaled from baseline indicates improvement in respiratory function.|Pre and 30 minutes post study drug administration|Per protocol||percentage change from baseline||Standard Deviation|Mean
653355|NCT01986985|Primary|PET/MR Images Clinical Usefulness|Clinically relevant images are obtained|1 day|Subjects with images successfully collected using PET/ MR||Participants|||Number
653356|NCT01986946|Secondary|Wound Infection Rates||during hospitalization (approximately 3-8 days)|Data not collected|||||
653357|NCT01986946|Secondary|Length of Hospital Stay||during hospitalization (approximately 3-8 days)|||days||Standard Deviation|Mean
653358|NCT01986946|Secondary|Number of Participants Readmitted to Hospital Within 30 Days of Surgery||Post-operative Day 30|||participants|||Number
653359|NCT01986946|Secondary|Number of Participants Experiencing Delirium||Post-operative Day 3|Participants who were evaluated for Delirium on Day 3||participants|||Number
653360|NCT01986946|Secondary|Number of Participants Experiencing Delirium||Post-operative Day 2|Participants who were evaluated for Delirium on Day 2||participants|||Number
653361|NCT01986946|Secondary|Number of Participants Experiencing Delirium||Post-operative Day 1|Only participants who had assessment for delirium are include in the analysis.||participants|||Number
653362|NCT01986946|Secondary|Total Post-operative Opioid Consumption||during hospitalization (approximately 3-8 days)|||oral morphine equivilant (mg)||Standard Deviation|Mean
653363|NCT01986946|Secondary|Number of Participants With Adverse Events Related to the Study|Patients will be assessed in the recovery room and each day of their epidural or intravenous opioid infusions, and at their surgical follow-up visit.|6-week Follow up Visit|||participants|||Number
653364|NCT01986946|Secondary|Number of Participants With Events of Special Interest|Patients will be assessed for development of a deep vein thrombosis after surgery, and surgical site infection.|Post-operative Day 30|Data not collected|||||
653365|NCT01986946|Secondary|Patient Satisfaction With Overall Care|Likert scale ranges from 1 to 5 (1=very satisfied and 5=Very Dissatisfied).|6-Week Follow up Visit|Participants who completed the patient satisfaction scale at the 6 week follow up visit.||units on a scale||Standard Deviation|Mean
653366|NCT01986946|Secondary|Patient Satisfaction With Perioperative Analgesia|Patients will be assessed for satisfaction with their peri-operative analgesia in the recovery room and each day of their epidural infusion or intravenous opioid infusion by the Acute Pain Service, and at their surgical follow-up visit. Likert scale ranges from 1 to 5 (1=very satisfied and 5=Very Dissatisfied).|6-Week Follow up Visit|Participants who completed the patient satisfaction scale at the 6 week follow up visit.||units on a scale||Standard Deviation|Mean
653367|NCT01986946|Secondary|Patient Satisfaction With Perioperative Analgesia|Patients will be assessed for satisfaction with their peri-operative analgesia in the recovery room and each day of their epidural infusion or intravenous opioid infusion by the Acute Pain Service, and at their surgical follow-up visit. Likert scale ranges from 1 to 5 (1=very satisfied and 5=Very Dissatisfied).|Post-operative Day 1|Analyasis was completed on all participants who completed the patient satisfaction with perioperative analgesia assessment.||units on a scale||Standard Deviation|Mean
653368|NCT01986946|Primary|Post-operative Pain as Assessed by Visual Analogue Scale (VAS)|The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain.|Postoperative day 1|Participant that provided a VAS score at postoperative day 1 time point.||units on a scale||Standard Deviation|Mean
653369|NCT01986855|Secondary|Percentage of Participants With A1C <7.0% (<53 mmol/Mol) at Week 26 - Baseline eGFR ≥45 to <60 mL/Min/1.73m^2 Stratum - Excluding Rescue Approach|A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Excluding rescue approach data analysis excluded all data following the initiation of rescue therapy at any time point, in order to avoid the confounding influence of the rescue therapy.|Week 26|The analysis population included all randomized participants with a Baseline eGFR ≥45 to <60 mL/min/1.73m^2 and who took at least 1 dose of study treatment and had at least 1 assessment at Week 26 for the percentage of participants with an A1C <7% at Week 26 endpoint.||Percentage of participants|||Number
653383|NCT01986751|Secondary|Compare the Subjects Mean Arterial Blood Pressure Effect of Perineural Clonidine Versus Placebo|Comparing the mean arterial blood pressure between the study group and the control group to assess the effect of clonidine on blood pressure.|baseline to discharge from hospital (expected 3 days)|Study was prematurely terminated. No data were collected for this assessment|||||
653371|NCT01986855|Secondary|Change From Baseline in Sitting Systolic Blood Pressure at Week 26 - Baseline eGFR ≥45 to <60 mL/Min/1.73m^2 Stratum - Excluding Rescue Approach|This change from baseline reflects the Week 26 sitting systolic blood pressure minus the Week 0 sitting systolic blood pressure. Excluding rescue approach data analysis excluded all data following the initiation of rescue therapy at any time point, in order to avoid the confounding influence of the rescue therapy.|Baseline and Week 26|The analysis population included all randomized participants with a Baseline eGFR of ≥45 to <60 mL/min/1.73m^2 and who took at least 1 dose of study treatment and had at least 1 assessment at or after baseline for the change from baseline at Week 26 sitting systolic blood pressure endpoint.||mmHg||95% Confidence Interval|Least Squares Mean
653372|NCT01986855|Secondary|Change From Baseline in Body Weight at Week 26 - Baseline eGFR ≥45 to <60 mL/Min/1.73m^2 Stratum - Excluding Rescue Approach|This change from baseline reflects the Week 26 body weight minus the Week 0 body weight. Excluding rescue approach data analysis excluded all data following the initiation of rescue therapy at any time point, in order to avoid the confounding influence of the rescue therapy.|Baseline and Week 26|The analysis population included all randomized participants with a Baseline eGFR of ≥45 to <60 mL/min/1.73m^2 and who took at least 1 dose of study treatment and had at least 1 assessment at or after baseline for the change from baseline at Week 26 body weight endpoint.||Kilograms||95% Confidence Interval|Least Squares Mean
653373|NCT01986855|Secondary|Change From Baseline in A1C at Week 26 - Baseline eGFR ≥45 to <60 mL/Min/1.73m^2 Stratum - Excluding Rescue Approach|A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 26 A1C minus the Week 0 A1C. Excluding rescue approach data analysis excluded all data following the initiation of rescue therapy at any time point, in order to avoid the confounding influence of the rescue therapy.|Baseline and Week 26|The analysis population included all randomized participants with a Baseline eGFR of ≥45 to <60 mL/min/1.73m^2 and who took at least 1 dose of study treatment and had at least 1 assessment at or after baseline for the change from baseline at Week 26 A1C endpoint.||Percentage||95% Confidence Interval|Least Squares Mean
653374|NCT01986855|Primary|Percentage of Participants Who Discontinued Study Treatment Due to an AE|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to 52 weeks|The analysis population included all randomized participants who received at least 1 dose of study treatment.||Percentage of participants|||Number
653375|NCT01986855|Primary|Percentage of Participants Who Experienced an Adverse Event (AE)|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to 54 weeks|The analysis population included all randomized participants who received at least 1 dose of study treatment.||Percentage of participants|||Number
653376|NCT01986855|Primary|Change From Baseline in A1C at Week 26 - Excluding Rescue Approach|A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 26 A1C minus the Week 0 A1C. Excluding rescue approach data analysis excluded all data following the initiation of rescue therapy at any time point, in order to avoid the confounding influence of the rescue therapy.|Baseline and Week 26|The analysis population included all randomized participants who took at least 1 dose of study treatment and had at least 1 assessment at or after baseline for the change from baseline at Week 26 A1C endpoint.||Percentage||95% Confidence Interval|Least Squares Mean
653377|NCT01986790|Primary|Satisfaction|A survey will be administered in order to measure the extent to which participants are satisfied with the information presented to them. Satisfaction was scored on a scale from 1 to 4, with higher scores indicating higher levels of satisfaction. Bivariate outcome data can be found below.|1 day (Immediately following showing the participant the assigned intervention (plain language table, plain language table + visuals, or plain language table + narratives)|Analysis is represented as mean (standard deviation) of calculated satisfaction.||Units on a scale||Standard Deviation|Mean
653378|NCT01986790|Primary|Uncertainty|A survey will be administered in order to measure participants' confidence in the features of health insurance plans that matter most to them and the insurance plan they chose of the ones presented. Confidence in choice is scored on a scale from 0 to 100, with higher scores indicating more decisional conflict/more uncertainty/less confidence in choice. Bivariate outcome data can be found below.|1 day (Immediately following showing the participant the assigned intervention (plain language table, plain language table + visuals, or plain language table + narratives)|Analysis is represented as mean (standard deviation) of calculated uncertainty.||Units on a scale||Standard Deviation|Mean
653379|NCT01986790|Primary|Knowledge|Knowledge measures the degree at which participants understand the details about health insurance plans. Knowledge was scored on a scale from 0 to 7 based on number of correct answers to the 7 items. A higher value is considered to be a better outcome. Bivariate outcome data can be found below.|1 day (Immediately following showing the participant the assigned intervention (plain language table, plain language table + visuals, or plain language table + narratives)|Analysis is represented as mean (standard deviation) of calculated knowledge.||Units on a scale||Standard Deviation|Mean
653380|NCT01986751|Secondary|Compare the Mean VAS Scores at 24 Hours Post Procedure to Determine the Patient Satisfaction on Duration of Postoperative Analgesia Between Control Group and Study Group|Compare the mean VAS scores at 24 hours between the study group and the control group to assess the efficacy of clonidine to control postoperative pain and patient satisfaction at the time of discharge.|baseline to 24 hours|Study was prematurely terminated. No data were collected for this assessment|||||
653381|NCT01986751|Secondary|Mean Time to First Analgesic Intake Postoperative Between the Control Group and the Study Group.|Comparing the mean time to the first analgesic intake postoperative between the control group and the study group|baseline to 24 hours post block|Study was prematurely terminated. No data were collected for this assessment|||||
653382|NCT01986751|Secondary|the Mean Time to Discharge After Start of Procedure for Each Group - Control and Study Group.|Comparing the mean hours from start of procedure to discharge between the study group and the control group|baseline to discharge (approximately 72 hours)|Study was prematurely terminated. No data were collected for this assessment|||||
653385|NCT01986751|Secondary|Compare the Mean VAS Scores at 24 Hours Post Procecure to Determine the Effectiveness of Perineural Clonidine on Duration of Postoperative Analgesia Between the Control Group and Study Group|The VAS score is measured as 0 - 10 with 0 being no pain to 10 being the worst pain imaginable to assess the efficacy of clonidine to control postoperative pain and patient satisfaction at the time of discharge.|baseline to 24 hours post block|Study was prematurely terminated. No data were collected for this assessment|||||
653386|NCT01986751|Primary|Compare the Mean Duration of Sensory and/or Motor Block Between the Study Group and the Control Group|Mean duration of sensory and/or motor block between the study group and the control group to assess the efficacy of clonidine to prolong the block duration.|baseline to 72 hours|Study was prematurely terminated. No data were collected for this assessment|||||
653387|NCT01986751|Primary|Mean Time to Onset of Sensory and Motor Block Between the Study Group and the Control Group|Mean time onset of sensory block and motor block between the study group and the control group to assess the efficacy of clonidine to prolong the block duration.|baseline to 72 hours|Study was prematurely terminated. No data were collected for this assessment.|||||
653388|NCT01986361|Secondary|Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Scale (STS) Over the 3 Hours Post-baseline (STS SPID3)|"The participant was asked to evaluate his/her sore throat when swallowing using a vertical 0-10 Likert scale, where 0=not sore and 10=very sore. The participant was instructed: Circle the number that shows how sore your throat is now when you swallow. STS was obtained at baseline, every 5 minutes after treatment during the first hour and every 10 minutes during the second and third hours, for a total of 24 post-dose measurements.
The time-weighted SPID combines relief magnitude (PID = change from baseline) as weighted by duration interval between ratings. SPID3 refers to measurements taken up to 3 hours post-baseline, and has a full range of -1332 (complete pain relief within 5 minutes of dosing that lasts for 3 hours) to 468 (drug escalates level of pain to a score of 10 and the pain stays at that level for 3 hours) using the mean baseline STS value 7.4 for this study."|Baseline (Day 1, pre-dose), up to 3 hours post dose on Day 1|Intent to treat||units on a scale||95% Confidence Interval|Mean
653389|NCT01986361|Secondary|Percentage of Participants With Perceived Pain Relief|Defined as the percentage of participants who pressed the first stopwatch during the 3 hour evaluation period.|up to 3 hours post dose on Day 1|Intent to treat||percentage of participants||95% Confidence Interval|Number
653390|NCT01986361|Secondary|Percentage of Participants With Meaningful Pain Relief|Defined as the percentage of participants who pressed the second stopwatch during the 3 hour evaluation period.|up to 3 hours post dose on Day 1|Intent to treat||percentage of participants||95% Confidence Interval|Number
653391|NCT01986361|Secondary|Change From Baseline at Individual Timepoints in Sore Throat Scale (STS)|"The participant was asked to evaluate his/her sore throat when swallowing using a vertical 0-10 Likert scale, where 0=not sore and 10=very sore. The participant was instructed: Circle the number that shows how sore your throat is now when you swallow. The STS was obtained at baseline, every 5 minutes after treatment during the first hour and every 10 minutes during the second and third hours."|Baseline (Day 1, pre-dose), up to 3 hours post dose on Day 1|Intent to treat||units on a scale||Standard Deviation|Mean
653392|NCT01986361|Secondary|Kaplan-Meier Estimates for Time of First Perceived Pain Reduction on the Sore Throat Scale (STS) Which is Followed by ≥ 20% Pain Reduction on the Sore Throat Pain Intensity Scale (STPIS)|"Time to pain reduction on the STS (defined as any reduction or decrease observed during the 3 hours post dose) for participants whose improvement was confirmed by a >=20% reduction in pain on the STPIS.
STS: The participant was asked to evaluate his/her sore throat when swallowing using a vertical 0-10 Likert scale, where 0=not sore and 10=very sore. The participant was instructed: Circle the number that shows how sore your throat is now when you swallow. The STS was obtained at baseline, every 5 minutes after treatment during the first hour and every 10 minutes during the second and third hours.
STPIS: The participant was instructed to swallow and: “Place a line on the Sore Throat Scale that best characterizes the severity of your sore throat now:” 0mm=no pain and 100mm=severe pain. The STPIS was obtained at baseline, after the participant depressed the second stopwatch, and at 1, 2, and 3 hours postdose."|Baseline (Day 1, pre-dose), up to 3 hours post dose on Day 1|Intent to treat||minutes||95% Confidence Interval|Median
653393|NCT01986361|Secondary|Kaplan-Meier Estimates for Time of First Indication of Sore Throat Relief as Measured By Any Reduction in the Sore Throat Scale (STS)|"Time to first indication of sore throat relief, defined as any reduction or decrease in STS observed during the 3 hours post dose. Participants who did not have any reduction in STS from baseline within 3 hours were censored to 3 hours.
The participant was asked to evaluate his/her sore throat when swallowing using a vertical 0-10 Likert scale, where 0=not sore and 10=very sore. The participant was instructed: “Circle the number that shows how sore your throat is now when you swallow.” The STS was obtained at baseline, every 5 minutes after treatment during the first hour and every 10 minutes during the second and third hours."|up to 3 hours post dose on Day 1|Intent to treat||minutes||95% Confidence Interval|Median
653394|NCT01986361|Secondary|Kaplan-Meier Estimates for Time to First Perceived Pain Relief That Is Confirmed By Meaningful Pain Relief|Time to first perceived pain relief on the first stopwatch that was confirmed by meaningful pain relief on the second stopwatch. Participants who had no meaningful pain relief within 3 hours from baseline were censored to 3 hours.|up to 3 hours post dose on Day 1|Intent to treat||minutes||95% Confidence Interval|Median
653395|NCT01986361|Secondary|Kaplan-Meier Estimates for Time of First Perceived Pain Relief|"Time to first perceived pain relief is a patient-reported outcome (PRO) captured as part of the double stopwatch method. Participants depress the first stop watch when they experience any pain relief, termed perceived pain relief. Instructions to participants are: “Stop the first stopwatch when you first feel any sore throat pain relief whatsoever. This does not mean you feel completely better, although you might, but when you first feel any relief of the throat pain you have now.” Participants who did not have perceived pain relief were censored at 3 hours."|up to 3 hours post dose on Day 1|Intent to treat||minutes||95% Confidence Interval|Median
653424|NCT01985126|Secondary|Time to Disease Progression|Time to progression was defined as the number of days from the date of first dose of daratumumab to the date of first record of disease progression.|Up to 14.4 Months|All treated Analysis Set included all participants who received at least 1 dose of daratumumab.||months||95% Confidence Interval|Median
654042|NCT01971086|Secondary|Subjective Assessment of the Patient of Overall Treatment Efficacy at the Closing/Final Visit.|The efficacy of the treatment was rated by the patient at the closing/final visit.|up to day 11|Patients from FAS||participants|||Number
653396|NCT01986361|Primary|Kaplan-Meier Estimates for Time to Meaningful Pain Relief|Time to meaningful pain relief is a patient-reported outcome (PRO) captured as part of the double stopwatch method. Participants depress the second stop watch when they experience what they perceive as meaningful pain relief. Instructions to participants are: “Stop the second stopwatch when the sore throat pain relief is meaningful to you. This does not mean you feel completely better, although you might, but when you feel relief of throat pain that is meaningful to you.” Participants who did not have perceived pain relief were censored at 3 hours.|up to 3 hours post dose on Day 1|Intent to treat population||minutes||95% Confidence Interval|Median
653397|NCT01986231|Secondary|Assess Difference in Hepatic Glycogen Measured in the Fed State Before vs. After Repeated Glucagon Administration|The mean difference in estimated hepatic glycogen will be assessed using Carbon 13 Magnetic Resonance Spectroscopy before vs. after glucagon administration in the fed state.|Baseline and 41 hours|||g/L||Standard Deviation|Mean
653398|NCT01986231|Primary|Assess Difference in Hepatic Glycogen Measured in the Fasting State Before vs. After Repeated Glucagon Administration|The mean difference in estimated hepatic glycogen will be assessed using Carbon 13 Magnetic Resonance Spectroscopy before vs. after glucagon administration in the fasting state.|Baseline and 41 hours|||g/L||Standard Deviation|Mean
653399|NCT01986062|Secondary|PERM-P Scores - Number of Problems Correct|Permanent Product Measure of Performance (PERMP) assessments measured during Laboratory Classroom Days. The PERMP is an individualized, five-page math exam consisting of 400 problems. Subjects are instructed to complete as many math problems as possible in 10 minutes. Performance is evaluated using the number of problems attempted (maximum score = 400) and the number of problems correct (maximum score = 400).|0.75, 2, 4, 6, 8, and 10 hours post-dose|ITT||number of problems correct||Standard Deviation|Mean
653400|NCT01986062|Secondary|PERM-P Scores - Number of Problems Attempted|Permanent Product Measure of Performance (PERMP) assessments measured during Laboratory Classroom Days. The PERMP is an individualized, five-page math exam consisting of 400 problems. Subjects are instructed to complete as many math problems as possible in 10 minutes. Performance is evaluated using the number of problems attempted (maximum score = 400) and the number of problems correct (maximum score = 400).|0.75, 2, 4, 6, 8, and 10 hours post-dose|ITT||number of problems attempted||Standard Deviation|Mean
653401|NCT01986062|Secondary|SKAMP Subscale - Deportment Scores|The SKAMP scale is a validated subjective measure of ADHD symptoms. It is comprised of 13 items (grouped under the subcategories of attention, deportment, quality of work, and compliance) on which subjects are rated according to a 7-point scale (0 = normal to 6 = maximal impairment). The SKAMP-Deportment subscale score is comprised of four of the 13 items with a maximum score of 24.|0.75, 2, 4, 6, 8, and 10 hours post-dose|||units on a scale||Standard Deviation|Mean
653402|NCT01986062|Secondary|SKAMP Subscale - Attention Scores|The SKAMP scale is a validated subjective measure of ADHD symptoms. It is comprised of 13 items (grouped under the subcategories of attention, deportment, quality of work, and compliance) on which subjects are rated according to a 7-point scale (0 = normal to 6 = maximal impairment). The SKAMP-Attention subscale score is comprised of four of the 13 items with a maximum score of 24.|0.75, 2, 4, 6, 8, and 10 hours post-dose|||units on a scale||Standard Deviation|Mean
653403|NCT01986062|Secondary|SKAMP-Combined Scores|Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale [SKAMP]-combined scores measured during Laboratory Classroom Days. The SKAMP scale is a validated subjective measure of ADHD symptoms in a laboratory classroom, comprised of 13 items on which subjects are rated according to a 7 point scale (0=normal to 6=maximal impairment); maximum score 78. The SKAMP-combined score is obtained by summing the rating values for each of the 13 items, whereby the higher the SKAMP score, the greater the impairment.|0.75, 4, 6, 8, 10 hours post-dose|||units on a scale||Standard Deviation|Mean
653404|NCT01986062|Primary|SKAMP-Combined Scores|Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale [SKAMP]-combined scores measured during Laboratory Classroom Days. The SKAMP scale is a validated subjective measure of ADHD symptoms in a laboratory classroom, comprised of 13 items on which subjects are rated according to a 7 point scale (0=normal to 6=maximal impairment); maximum score 78. The SKAMP-combined score is obtained by summing the rating values for each of the 13 items, whereby the higher the SKAMP score, the greater the impairment.|2 hours post-dose|ITT Population||units on a scale||Standard Deviation|Mean
653405|NCT01985685|Secondary|Change in Central Venous Oxygen Saturation|Change in central venous oxygen saturation|6 hrs|||percent||Inter-Quartile Range|Median
653406|NCT01985685|Secondary|Percentage Change in Serum Lactate|Percentage change in serum lactate|6 hrs|||percentage change||Inter-Quartile Range|Median
653407|NCT01985685|Primary|Change in VO2 Over Time|The primary outcome will be the change in VO2 over the 6 hours after administration of the study medication, adjusted for baseline VO2.|6 hrs|||ml/kg/min||Inter-Quartile Range|Median
653408|NCT01985581|Secondary|Evaluate the Effect of Adjunct Therapy on ADHD Symptom Control as Assessed by the Change in Clinical Global Impression of Improvement (CGI-I) Scale|CGI-I is a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Subjects who felt very much improved or much improved are considered improved.The outcome measure is reporting the percentage of participants showing improvement|comparison from baseline to end of each 12 week treatment arm|ITT population - consisting of subjects who took at least one dose of treatment and completed at least one non-baseline questionnaire during either period 1 or period 2.||percentage of subjects|||Number
653409|NCT01985581|Secondary|Effect of Adjunct Therapy on ADHD Symptom Control as Assessed by the Change on the Clinical Global Impression of Severity (CGI-S) Scale|The Clinical Global Impression- Severity scale is a scale of illness ranging from 1 (normal) to 7 (among the most severely ill patients). Subjects who felt normal, not at all ill or borderline mentally ill are considered improved. The outcome measure is reporting the percentage of participants showing improvement|comparison from baseline to end of each 12 week treatment arm|ITT population - consisting of subjects who took at least one dose of treatment and completed at least one non-baseline questionnaire during either period 1 or period 2.||percentage of subjects|||Number
653458|NCT01984294|Primary|Percentage of Participants Permanently Discontinuing Any Study Drug Due to an Adverse Event||Up to 8 weeks|Safety Analysis Set: participants were randomized and received at least one dose of study drug.||percentage of participants|||Number
653522|NCT01982435|Primary|Number of Participants With Severe Non-ocular Adverse Event|As identified by physical examination, subject reporting, and changes in vital signs. These outcome measures are also included in more detail in the adverse event section of the results.|12 months|||Participants|||Count of Participants
653410|NCT01985581|Secondary|Evaluate the Effect of Adjunctive INTUNIV Extended Release Treatment on Change in Quality of Life as Assessed by the KINDL®-Parent Questionnaire.|The KINDL is a quality of life questionnaire of 24 items completed by the parent (KINDL-parent). It is a generic instrument for assessing Health Related quality of life in children and adolescents aged 3 years and older. Norm values are given based on representative German data from the German National Health Interview and Examination Survey for Children and Adolescents (KiGGS) study, a broad survey realized by the German Robert-Koch Institute. The KINDL scores were converted to range between 0 and 100 with higher scores indicating better quality of life as reported by the parent.|Measured at baseline and end of each 12 week treatment arm|ITT population - consisting of subjects who took at least one dose of treatment and completed at least one non-baseline questionnaire during either period 1 or period 2.||units on a scale||Standard Error|Mean
653411|NCT01985581|Secondary|Subjects Experiencing Suicidal Ideation, Suicidal Behaviour and Self-injurious Behaviour Without Suicidal Intent and Incident of Serious Adverse Events in Each Treatment Arm|To compare the number of subjects experiencing suicidal ideation, suicidal behaviour and self-injurious behaviour without suicidal intent as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) and incident of Serious Adverse Events (SAEs) in each treatment arm|Measured up to 30 weeks|ITT population - consisting of subjects who took at least one dose of treatment and completed at least one non-baseline questionnaire during either period 1 or period 2.||subjects|||Number
653412|NCT01985581|Secondary|Effect of Adjunct Therapy on ADHD Symptom Control as Assessed by the Change in the ADHD Rating Scale (ADHD-RS-IV)|The ADHD-RS-IV is completed by the Investigator familiar with the scale. It is an 18 item scale designed to reflect current symptomatology of ADHD based on the DSM-5 criteria. Each item is scored from a range of 0 (reflecting no symptoms) to 3 (reflecting severe symptoms) with total scores ranging from 0-54, with higher scores reflecting more severe symptoms|comparison from baseline to end of each 12 week treatment arm|ITT population - consisting of subjects who took at least one dose of treatment and completed at least one non-baseline questionnaire during either period 1 or period 2.||units on a scale||Standard Error|Mean
653413|NCT01985581|Secondary|Effect of Adjunctive INTUNIV Extended Release Treatment on Change in Quality of Life as Assessed by the KINDL®-Child Questionnaire.|The KINDL is a quality of life questionnaire of 24 items completed by the subject (KINDL-child). It is a generic instrument for assessing Health Related quality of life in children and adolescents aged 3 years and older. Norm values are given based on representative German data from the German National Health Interview and Examination Survey for Children and Adolescents (KiGGS) study, a broad survey realized by the German Robert-Koch Institute. The KINDL scores were converted to range between 0 and 100 with higher scores indicating better quality of life as reported by the child|Measured at baseline and end of each 12 week treatment arm|ITT population - consisting of subjects who took at least one dose of treatment and completed at least one non-baseline questionnaire during either period 1 or period 2.||units on a scale||Standard Error|Mean
653414|NCT01985581|Primary|Effect of Adjunctive INTUNIV Extended Release Treatment on Executive Function as Assessed by Change From Baseline on the BRIEF-parent Questionnaires|The Behavioural Rating Inventory of Executive Function (BRIEF) was developed to assess such real-world expressions of executive function in the home (BRIEF-P) as assessed by the parent. This is an 86 item questionnaire completed by the parents. The score is converted to a t-score with a score less than 65 being considered within the normal range. Higher scores are worsening in function.|measured at baseline and end of each 12 week treament arm|ITT population - consisting of subjects who took at least one dose of treatment and completed at least one non-baseline BRIEF questionnaire during either period 1 or period 2.||units on a scale||Standard Error|Mean
653415|NCT01985425|Secondary|Post-operative Infection||Post-operative Day 1 until Postoperative Day 30|||Participants|||Count of Participants
653416|NCT01985425|Secondary|Transient Ischemic Attack (TIA)|New focal neurological deficit thought to be vascular in origin with signs and symptoms lasting less than 24 hours.|Post-operative Day 1 until Postoperative Day 30|||Participants|||Count of Participants
653417|NCT01985425|Secondary|Stroke|New focal neurological deficit thought to be vascular in origin with signs and symptoms lasting more than 24 hours and cerebral imaging consistent with acute stroke.|Post-operative Day 1 until Postoperative Day 30|||Participants|||Count of Participants
653418|NCT01985425|Secondary|Myocardial Injury After Non-Cardiac Surgery (MINS)|"Requires one of the following criteria:
A) Elevated troponin or CK-MB measurement with one or more of the following defining features:
Ischemic signs or symptoms (i.e., chest, arm, neck, or jaw discomfort; shortness of breath, pulmonary edema);
Development of pathologic Q waves present in any two contiguous leads that are >30 milliseconds;
Electrocardiogram (ECG) changes indicative of ischemia (i.e., ST segment elevation [>2 mm in leads V1, V2, or V3 OR >1 mm in the other leads], ST segment depression [>1 mm], OR symmetric inversion of T waves >1 mm) in at least two contiguous leads;
New LBBB; or v. new or presumed new cardiac wall motion abnormality on echocardiography or new or presumed new fixed defect on radionuclide imaging;
B) Elevated troponin measurement after surgery with no alternative explanation (e.g., pulmonary embolism, sepsis) to myocardial injury"|Post-operative Day 1 until Postoperative Day 30|||Participants|||Count of Participants
653419|NCT01985425|Secondary|New Onset Atrial Flutter|Replacement of the consistent P waves on 12-lead ECG, or documented telemetry tracing, by saw-tooth flutter waves.|Post-operative Day 1 until Postoperative Day 30|||Participants|||Count of Participants
653420|NCT01985425|Secondary|Death||Post-operative Day 1 until Postoperative Day 30|||Participants|||Count of Participants
653421|NCT01985425|Primary|Clinically Significant Atrial Fibrillation|New atrial fibrillation that results in angina, congestive heart failure, symptomatic hypotension, or that requires treatment with a rate controlling drug, antiarrhythmic drug, or electrical cardioversion, or that lasts for longer than 30 seconds.|Post-operative Day 1 until Postoperative Day 30|||Participants|||Count of Participants
653422|NCT01985321|Secondary|Number of Treatment Related Adverse Events||Days 1-28|||participants|||Number
653423|NCT01985321|Primary|Clinician Assessed Duration of Complete Healing of the Herpetic Episode||Days 1-14|Modified Intent to Treat Population: 2 subjects in placebo group violated protocol and could not be evaluated for Complete Healing (83-2=81). 5 subjects in active group started treatment prior to contacting site; 1 subject in active group lost to follow-up with no site visits. These 6 active subjects not used in Complete Healing analysis (90-6=84)||hours||Full Range|Median
653425|NCT01985126|Secondary|Progression Free Survival|Progression free survival was defined as the time between the date of first dose of daratumumab and either disease progression or death, whichever occurred first. Disease progression as per IMWG criteria: increase of >=25 percent from lowest response level in Serum M-component and/or (the absolute increase must be >=0.5 g/dL) Urine M-component and/or (the absolute increase must be >=200 mg/24 hour; only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain levels. The absolute increase must be >10 mg/dL; Bone marrow plasma cell percentage: the absolute percent must be >=10 percent; Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder.|Up to 14.4 Months|All treated Analysis Set included all participants who received at least 1 dose of daratumumab.||months||95% Confidence Interval|Median
653426|NCT01985126|Secondary|Time to Response|Time to response was defined as the time from the date of first dose of daratumumab to the date of initial documentation of a response (PR [>= 50 percent reduction of serum M-protein and reduction in 24-hour urinary M-protein by >= 90 percent] or better).|Up to 14.4 Months|Responders in All Treated Analysis Set. Only those participants with confirmed PR were analyzed.||months||Full Range|Median
653427|NCT01985126|Secondary|Percentage of Participants With Clinical Benefit|Clinical benefit rate was defined as the percentage of participants with best response of minimal response (MR) or better (including PR [>= 50 percent reduction of serum M-protein and reduction in 24-hour urinary M-protein by >= 90 percent], VGPR [Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90 percent or greater reduction in serum M-protein plus urine M-protein level <100 mg per 24 hour], CR [Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5 percent plasma cells in bone marrow], and sCR [CR+Normal free light chain ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence]).|Up to 14.4 Months|All treated Analysis Set included all participants who received at least 1 dose of daratumumab.||percentage of participants||95% Confidence Interval|Number
653428|NCT01985126|Secondary|Overall Survival|Overall survival was defined as the time from the date of first dose of daratumumab to the date of the partcipant’s death from any cause.|Up to 14.4 Months|All treated Analysis Set included all participants who received at least 1 dose of daratumumab.||months||95% Confidence Interval|Median
653429|NCT01985126|Secondary|Duration of Response|Duration of response was calculated from the date of initial documentation of a response (PR [>= 50 percent reduction of serum M-protein and reduction in 24-hour urinary M-protein by >= 90 percent] or better) to the date of first documented evidence of progressive disease, as defined in the IMWG criteria.|Up to 14.4 Months|Responders in All Treated Analysis Set. Only those participants with confirmed PR and those who experienced progressive disease were analyzed.||months||95% Confidence Interval|Median
653430|NCT01985126|Primary|Percentage of Participants With Overall Response|Overall response defined as percentage of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR). IMWG criteria- CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and less than (<)5 percent plasma cells in bone marrow; sCR: CR+Normal free light chain (FLC) ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; PR: greater than or equal to (>=) 50 percent reduction of serum M-protein and reduction in 24-hour urinary M-protein by >= 90 percent; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90 percent or greater reduction in serum M-protein plus urine M-protein level less than (<) 100 milligram (mg) per 24 hour.|Up to 14.4 Months|All treated Analysis set included all participants who received at least 1 dose of daratumumab.||percentage of participants||95% Confidence Interval|Number
653431|NCT01984697|Secondary|Percentage of Participants With Seroconversion to HPV Type 58 at Four Weeks After the Last Dose of V503|Antibodies to HPV VLP type 58 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 58 was defined as a titer >=8 mMU/mL.|4 weeks after the last dose of V503 (Month 7 or Month 13)|The per-protocol population included all participants who 1) received all planned vaccinations, 2) had a serum sample collected 4 weeks after the last vaccination, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.||Percentage of participants||95% Confidence Interval|Number
653432|NCT01984697|Secondary|Percentage of Participants With Seroconversion to HPV Type 52 at Four Weeks After the Last Dose of V503|Antibodies to HPV VLP type 52 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 52 was defined as a titer >=8 mMU/mL.|4 weeks after the last dose of V503 (Month 7 or Month 13)|The per-protocol population included all participants who 1) received all planned vaccinations, 2) had a serum sample collected 4 weeks after the last vaccination, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.||Percentage of participants||95% Confidence Interval|Number
653433|NCT01984697|Secondary|Percentage of Participants With Seroconversion to HPV Type 45 at Four Weeks After the Last Dose of V503|Antibodies to HPV VLP type 45 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 45 was defined as a titer >=8 mMU/mL.|4 weeks after the last dose of V503 (Month 7 or Month 13)|The per-protocol population included all participants who 1) received all planned vaccinations, 2) had a serum sample collected 4 weeks after the last vaccination, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.||Percentage of participants||95% Confidence Interval|Number
653434|NCT01984697|Secondary|Percentage of Participants With Seroconversion to HPV Type 33 at Four Weeks After the Last Dose of V503|Antibodies to HPV VLP type 33 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 33 was defined as a titer >=8 mMU/mL.|4 weeks after the last dose of V503 (Month 7 or Month 13)|The per-protocol population included all participants who 1) received all planned vaccinations, 2) had a serum sample collected 4 weeks after the last vaccination, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.||Percentage of participants||95% Confidence Interval|Number
654043|NCT01971086|Secondary|Subjective Assessment of the Physicians of Overall Treatment Efficacy at the Closing/Final Visit.|The efficacy of the treatment was rated by the physician at the closing/final visit for every patient.|up to day 11|Patients from FAS.||participants|||Number
653435|NCT01984697|Secondary|Percentage of Participants With Seroconversion to HPV Type 31 at Four Weeks After the Last Dose of V503|Antibodies to HPV VLP type 31 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 31 was defined as a titer >=10 mMU/mL.|4 weeks after the last dose of V503 (Month 7 or Month 13)|The per-protocol population included all participants who 1) received all planned vaccinations, 2) had a serum sample collected 4 weeks after the last vaccination, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.||Percentage of participants||95% Confidence Interval|Number
653436|NCT01984697|Secondary|Percentage of Participants With Seroconversion to HPV Type 18 at Four Weeks After the Last Dose of V503|Antibodies to HPV VLP type 18 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 18 was defined as a titer >=24 mMU/mL.|4 weeks after the last dose of V503 (Month 7 or Month 13)|The per-protocol population included all participants who 1) received all planned vaccinations, 2) had a serum sample collected 4 weeks after the last vaccination, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.||Percentage of participants||95% Confidence Interval|Number
653437|NCT01984697|Secondary|Percentage of Participants With Seroconversion to HPV Type 16 at Four Weeks After the Last Dose of V503|Antibodies to HPV VLP type 16 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 16 was defined as a titer >=20 mMU/mL.|4 weeks after the last dose of V503 (Month 7 or Month 13)|The per-protocol population included all participants who 1) received all planned vaccinations, 2) had a serum sample collected 4 weeks after the last vaccination, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.||Percentage of participants||95% Confidence Interval|Number
653438|NCT01984697|Secondary|Percentage of Participants With Seroconversion to HPV Type 11 at Four Weeks After the Last Dose of V503|Antibodies to HPV VLP type 11 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 11 was defined as a titer >=16 mMU/mL.|4 weeks after the last dose of V503 (Month 7 or Month 13)|The per-protocol population included all participants who 1) received all planned vaccinations, 2) had a serum sample collected 4 weeks after the last vaccination, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.||Percentage of participants||95% Confidence Interval|Number
653439|NCT01984697|Primary|Geometric Mean Titers to HPV Type 58 at Four Weeks After the Last Dose of V503|Antibodies to HPV VLP type 58 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).|4 weeks after the last dose of V503 (Month 7 or Month 13)|The per-protocol population included all participants who 1) received all planned vaccinations, 2) had a serum sample collected 4 weeks after the last vaccination, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.||mMU/mL||95% Confidence Interval|Geometric Mean
653440|NCT01984697|Primary|Geometric Mean Titers to HPV Type 52 at Four Weeks After the Last Dose of V503|Antibodies to HPV VLP type 52 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).|4 weeks after the last dose of V503 (Month 7 or Month 13)|The per-protocol population included all participants who 1) received all planned vaccinations, 2) had a serum sample collected 4 weeks after the last vaccination, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.||mMU/mL||95% Confidence Interval|Geometric Mean
653441|NCT01984697|Primary|Geometric Mean Titers to HPV Type 45 at Four Weeks After the Last Dose of V503|Antibodies to HPV VLP type 45 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).|4 weeks after the last dose of V503 (Month 7 or Month 13)|The per-protocol population included all participants who 1) received all planned vaccinations, 2) had a serum sample collected 4 weeks after the last vaccination, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.||mMU/mL||95% Confidence Interval|Geometric Mean
653442|NCT01984697|Primary|Geometric Mean Titers to HPV Type 33 at Four Weeks After the Last Dose of V503|Antibodies to HPV VLP type 33 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).|4 weeks after the last dose of V503 (Month 7 or Month 13)|The per-protocol population included all participants who 1) received all planned vaccinations, 2) had a serum sample collected 4 weeks after the last vaccination, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.||mMU/mL||95% Confidence Interval|Geometric Mean
653443|NCT01984697|Primary|Geometric Mean Titers to HPV Type 31 at Four Weeks After the Last Dose of V503|Antibodies to HPV VLP type 31 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).|4 weeks after the last dose of V503 (Month 7 or Month 13)|The per-protocol population included all participants who 1) received all planned vaccinations, 2) had a serum sample collected 4 weeks after the last vaccination, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.||mMU/mL||95% Confidence Interval|Geometric Mean
653444|NCT01984697|Primary|Geometric Mean Titers to HPV Type 18 at Four Weeks After the Last Dose of V503|Antibodies to HPV VLP type 18 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).|4 weeks after the last dose of V503 (Month 7 or Month 13)|The per-protocol population included all participants who 1) received all planned vaccinations, 2) had a serum sample collected 4 weeks after the last vaccination, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.||mMU/mL||95% Confidence Interval|Geometric Mean
653445|NCT01984697|Primary|Geometric Mean Titers to HPV Type 16 at Four Weeks After the Last Dose of V503|Antibodies to HPV VLP type 16 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).|4 weeks after the last dose of V503 (Month 7 or Month 13)|The per-protocol population included all participants who 1) received all planned vaccinations, 2) had a serum sample collected 4 weeks after the last vaccination, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.||mMU/mL||95% Confidence Interval|Geometric Mean
653446|NCT01984697|Primary|Geometric Mean Titers to HPV Type 11 at Four Weeks After the Last Dose of V503|Antibodies to HPV VLP type 11 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).|4 weeks after the last dose of V503 (Month 7 or Month 13)|The per-protocol population included all participants who 1) received all planned vaccinations, 2) had a serum sample collected 4 weeks after the last vaccination, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.||mMU/mL||95% Confidence Interval|Geometric Mean
653447|NCT01984697|Secondary|Percentage of Participants With Seroconversion to HPV Type 6 at Four Weeks After the Last Dose of V503|Antibodies to HPV VLP type 6 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 6 was defined as a titer >=30 mMU/mL.|4 weeks after the last dose of V503 (Month 7 or Month 13)|The per-protocol population included all participants who 1) received all planned vaccinations, 2) had a serum sample collected 4 weeks after the last vaccination, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.||Percentage of participants||95% Confidence Interval|Number
653448|NCT01984697|Primary|Geometric Mean Titers to Human Papillomavirus (HPV) Type 6 at Four Weeks After the Last Dose of V503|Antibodies to HPV virus-like particles (VLP) type 6 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).|4 weeks after the last dose of V503 (Month 7 or Month 13)|The per-protocol population included all participants who 1) received all planned vaccinations, 2) had a serum sample collected 4 weeks after the last vaccination, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.||mMU/mL||95% Confidence Interval|Geometric Mean
653449|NCT01984684|Secondary|Investigator-assessed Response of Signs and Symptoms of Infection at the Late Follow-up Visit|"A patient was considered a Cure if all baseline signs and symptoms of ABSSSI had resolved; if some symptoms remained, but the patient was improved to the extent that no additional antibiotic treatment was necessary, the response was Improved. A patient was considered a Failure for any of the following reasons: nonstudy antibacterial drug therapy was required because of lack of efficacy after at least 4 doses of study drug or for a treatment-related AE; study antibacterial drug therapy was required for longer than 28 doses; and/or unplanned surgical intervention was needed after study entry except for limited bedside debridement and standard wound care. Improved and Indeterminate responses were considered failures in the primary analysis.
A sensitivity analysis was also performed, in which the assigned responses were Success (Cure + Improved) or Failure (Failure + Indeterminate/Missing)."|Study Day 21 to 28|||Participants|||Count of Participants
653450|NCT01984684|Secondary|Investigator-assessed Response of Signs and Symptoms of Infection at the Follow up Visit (European Medicines Agency [EMA] Primary Endpoint)|"A patient was considered a Cure if all baseline signs and symptoms of ABSSSI had resolved; if some symptoms remained, but the patient was improved to the extent that no additional antibiotic treatment was necessary, the response was Improved. A patient was considered a Failure for any of the following reasons: nonstudy antibacterial drug therapy was required because of lack of efficacy after at least 4 doses of study drug or for a treatment-related AE; study antibacterial drug therapy was required for longer than 28 doses; and/or unplanned surgical intervention was needed after study entry except for limited bedside debridement and standard wound care. Improved and Indeterminate responses were considered failures in the primary analysis.
A sensitivity analysis was also performed, in which the assigned responses were Success (Cure + Improved) or Failure (Failure + Indeterminate/Missing)."|Study Day 14 ± 1|ITT Population||Participants|||Count of Participants
653451|NCT01984684|Primary|Objective Response of ≥20% Reduction in Lesion Erythema Area Compared to Baseline at 48 to 72 Hours After Initiation of Treatment as Determined by Digital Measurements of the Leading Edge.|A patient was considered a responder if s/he had a ≥20% reduction in size of the area of erythema associated with the baseline ABSSSI, as determined by digital planimetry of the leading edge and had none of the reasons for clinical failure; a patient was considered a non-responder (failure) if s/he had <20% reduction in size of the area of erythema associated with the baseline ABSSSI as determined by digital planimetry of the leading edge, or had major intervention such as another antibiotic or surgical intervention or died within 74 hours after initiation of study drug.|48 to 72 hrs after starting treatment|ITT Population||Participants|||Count of Participants
653452|NCT01984515|Secondary|Patient Health Questionnaire-9 Item|9 symptoms of depression are measured on a 0-3 scale. Total scale range is 0-27, with higher scores indicating worse depression.|Referral Management Initiation, 1 month post initiation, 3 months post initiation|||units on a scale||Standard Deviation|Mean
653453|NCT01984515|Secondary|PTSD Checklist-Specific|Measures the 17 symptoms of PTSD according to the DSM-IV. Scale for each item ranges from 1-5. Total scale score ranges from 17-85. 17 represents no PTSD symptoms and 85 represented the most severe PTSD symptoms.|Referral Management Initiation, 1 month post initiation, 3 months post initiation|||units on a scale||Standard Deviation|Mean
653454|NCT01984515|Primary|Engagement in Evidence-based Psychotherapy for PTSD|Engagement will be assessed by how many patients attend at least 2 sessions of an evidence-based psychotherapy for PTSD and how many complete treatment. Completion is defined as 8 sessions.|From initiation of the Referral Management System to 6 months after initiation|||participants|||Number
653455|NCT01984294|Secondary|Percentage of Participants Experiencing Viral Relapse|Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) at end of treatment, but did not achieve an SVR.|Up to Posttreatment Week 24|Full Analysis Set||percentage of participants|||Number
653456|NCT01984294|Secondary|Percentage of Participants Experiencing On-treatment Virologic Failure|"On-treatment virologic failure was defined as
Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)"|Up to 8 weeks|Full Analysis Set||percentage of participants|||Number
653457|NCT01984294|Secondary|Percentage of Participants With Sustained Virologic Response at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR24)|SVR2, SVR4, SVR8, and SVR24 was defined as HCV RNA < LLOQ at 2, 4, 8, and 24 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 2, 4, 8, and 24|Full Analysis Set||percentage of participants|||Number
653459|NCT01984294|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) 12 weeks following the last dose of study drug.|Posttreatment Week 12|Full Analysis Set: participants were randomized and received at least one dose of study drug.||percentage of participants|||Number
653460|NCT01984229|Secondary|t1/2 of RO5468924: Cohort B|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. RO5468924 is M4 metabolite of Alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period, and additional samples were collected in Period 3 at 120, 144, 168, 192, and 216 hours after dosing|PK Analysis Population [Cohort B]||hours||Standard Deviation|Mean
653461|NCT01984229|Secondary|t1/2 of RO5468924: Cohort A|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. RO5468924 is M4 metabolite of Alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period|PK analysis population [Cohort A]. Here, number of participants analyzed = participants who were evaluable for this outcome.||hours||Standard Deviation|Mean
653462|NCT01984229|Secondary|t1/2 of Alectinib: Cohort B|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period, and additional samples were collected in Period 3 at 120, 144, 168, 192, and 216 hours after dosing|PK Analysis Population [Cohort B]||hours||Standard Deviation|Mean
653463|NCT01984229|Secondary|Terminal Half-life (t1/2) of Alectinib: Cohort A|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period|PK analysis population [Cohort A]||hours||Standard Deviation|Mean
653464|NCT01984229|Secondary|Metabolite/Parent Ratio for Cmax: Cohort B|RO5468924 is M4 metabolite of Alectinib. The ratio is molecular weight adjusted.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period, and additional samples were collected in Period 3 at 120, 144, 168, 192, and 216 hours after dosing|PK Analysis Population [Cohort B]||ratio||Standard Deviation|Geometric Mean
653465|NCT01984229|Secondary|Metabolite/Parent Ratio for AUC0-inf: Cohort B|AUC (0-inf) = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0 - t) plus AUC (t - inf). RO5468924 is M4 metabolite of Alectinib. The ratio is molecular weight adjusted.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period, and additional samples were collected in Period 3 at 120, 144, 168, 192, and 216 hours after dosing|PK Analysis Population [Cohort B]||ratio||Standard Deviation|Geometric Mean
653466|NCT01984229|Secondary|Tmax of RO5468924: Cohort B|RO5468924 is M4 metabolite of Alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period, and additional samples were collected in Period 3 at 120, 144, 168, 192, and 216 hours after dosing|PK Analysis Population [Cohort B]||hours||Full Range|Median
653467|NCT01984229|Secondary|Tmax of RO5468924: Cohort A|RO5468924 is M4 metabolite of Alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period|PK analysis population [Cohort A]||hours||Full Range|Median
653468|NCT01984229|Secondary|Tmax of Alectinib: Cohort B||Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period|PK Analysis Population [Cohort B]||hours||Full Range|Median
653469|NCT01984229|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Alectinib: Cohort A||Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period|PK analysis population [Cohort A]||hours||Full Range|Median
653470|NCT01984229|Secondary|AUC0-inf of RO5468924: Cohort B|AUC (0-inf) = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0 - t) plus AUC (t - inf). RO5468924 is M4 metabolite of Alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period, and additional samples were collected in Period 3 at 120, 144, 168, 192, and 216 hours after dosing|PK Analysis Population [Cohort B]||h*ng/mL||Standard Deviation|Mean
653471|NCT01984229|Secondary|AUClast of RO5468924: Cohort B|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). RO5468924 is M4 metabolite of Alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period, and additional samples were collected in Period 3 at 120, 144, 168, 192, and 216 hours after dosing|PK Analysis Population [Cohort B]||h*ng/mL||Standard Deviation|Mean
653472|NCT01984229|Secondary|Cmax of RO5468924: Cohort B|RO5468924 is M4 metabolite of Alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period, and additional samples were collected in Period 3 at 120, 144, 168, 192, and 216 hours after dosing|PK Analysis Population [Cohort B]||ng/mL||Standard Deviation|Mean
653473|NCT01984229|Secondary|AUC0-inf of RO5468924: Cohort A|AUC (0-inf) = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0 - t) plus AUC (t - inf). RO5468924 is M4 metabolite of Alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period|PK Analysis Population [Cohort A]. Here, number of participants analyzed = participants who were evaluable for this outcome.||h*ng/mL||Standard Deviation|Mean
653474|NCT01984229|Secondary|AUClast of RO5468924: Cohort A|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). RO5468924 is M4 metabolite of Alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period|PK Analysis Population [Cohort A]||h*ng/mL||Standard Deviation|Mean
653475|NCT01984229|Secondary|Cmax of RO5468924: Cohort A|RO5468924 is M4 metabolite of Alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period|PK Analysis Population [Cohort A]||ng/mL||Standard Deviation|Mean
653523|NCT01982435|Primary|Number of Participants With Non-severe Non-ocular Adverse Event|As identified by physical examination, subject reporting, and changes in vital signs. These outcome measures are also included in more detail in the adverse event section of the results.|12 months|||Participants|||Count of Participants
653476|NCT01984229|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC0-inf) of RO5424802: Cohort B|AUC (0-inf) = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0 - t) plus AUC (t - inf).|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period, and additional samples were collected in Period 3 at 120, 144, 168, 192, and 216 hours after dosing|PK Analysis Population [Cohort B]||h*ng/mL||Standard Deviation|Mean
653477|NCT01984229|Primary|AUClast of Alectinib: Cohort B|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period, and additional samples were collected in Period 3 at 120, 144, 168, 192, and 216 hours after dosing|PK Analysis Population [Cohort B]||h*ng/mL||Standard Deviation|Mean
653478|NCT01984229|Primary|Cmax of Alectinib: Cohort B||Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period, and additional samples were collected in Period 3 at 120, 144, 168, 192, and 216 hours after dosing|PK Analysis Population [Cohort B] consisted of all participants who received both scheduled doses of Alectinib, and provided adequate PK assessments.||ng/mL||Standard Deviation|Mean
653479|NCT01984229|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Alectinib: Cohort A|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period|PK Analysis Population [Cohort A]||hours*nanograms per milliliter (h*ng/mL)||Standard Deviation|Mean
653480|NCT01984229|Primary|Maximum Observed Plasma Concentration (Cmax) of Alectinib: Cohort A||Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period|Pharmacokinetic (PK) Analysis Population [Cohort A] consisted of all participants who received both scheduled doses of Alectinib, and provided adequate PK assessments.||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
653481|NCT01983878|Secondary|PK: Area Under the Curve Time Zero to Infinity (AUC[0-∞]) of Ramucirumab||Cycle 1 Day 1: Pre-Dose, End of Infusion: 1, 4, 23, 47, 95, 167, 263, and 335 Hours Post-Dose|PK population: Enrolled participants who received at least one dose of the study drug and had evaluable ramucirumab PK data.||hours x micrograms/milliliters (h*μg/mL)||Geometric Coefficient of Variation|Geometric Mean
653482|NCT01983878|Secondary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ramucirumab||Cycle 1 Day 1: Pre-Dose, End of Infusion. 1, 4, 23, 47, 95, 167, 263, and 335 Hours Post-Dose|PK population: enrolled participants who received at least one dose of the study drug and had evaluable ramucirumab PK data.||micrograms/milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
653483|NCT01983878|Secondary|Number of Participants With Anti-Ramucirumab Antibodies|A sample will be considered positive for circulating anti-ramucirumab antibodies if it exhibits a post-baseline antibody level that exceeds the upper 95% confidence interval of the mean determined from the normal anti-ramucirumab level seen in healthy untreated individuals. A participant will be considered to have an anti-ramucirumab response if there are 2 consecutive positive samples or if the final sample tested is positive.|Cycle 1: Pre-infusion, Cycle 2: Pre-infusion, Cycle 3: Pre-infusion, Follow Up|All enrolled participants who received at least one dose of study drug and had evaluable immunogenicity data.||participants|||Number
653484|NCT01983878|Secondary|Overall Survival (OS)|The OS time is defined as the time from baseline to the date of death from any cause. If a participant is not known to have died on or before the date of data cut-off, OS data will be censored on the last date (on or before the cut-off date) the participant was known to be alive.|Baseline to Death from Any Cause (Up to 13 Months)|FAS: all enrolled participants who received at least one dose of the study drug. 18 participants were censored.||Months||90% Confidence Interval|Median
653485|NCT01983878|Secondary|Percentage of Participants Achieving Stable Disease (SD) or a Confirmed CR or PR [Disease Control Rate (DCR)]|Participants achieved disease control if they had a best overall response of CR, PR or SD. According to RECIST v1.1, CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all non-target lesions, and the normalization of tumor marker levels (if tumor markers were initially above the ULN); PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter. SD was neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started. The percentage of participants who achieved disease control = (number of participants with CR, PR, or SD)/(number of participants assessed)*100.|Baseline to Measured PD or Death from Any Cause (Up to 12 Months)|FAS: all enrolled participants who received at least one dose of the study drug.||Percentage of Participants||90% Confidence Interval|Number
653486|NCT01983878|Secondary|Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]|Participants achieved an objective response if they had a best overall response of CR or PR. According to RECIST v1.1, PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter; CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels [if tumor markers were initially above the upper limit of normal (ULN)]. The percentage of participants who achieved an objective response = (number of participants with CR or PR)/(number of participants assessed)*100.|Baseline to Measured PD or Death from Any Cause (Up to 38.0 Weeks)|FAS: all enrolled participants who received at least one dose of the study drug.||Percentage of Participants||90% Confidence Interval|Number
653487|NCT01983878|Secondary|Progression-Free Survival (PFS)|The time from baseline to measured Progressive Disease (PD) as defined by RECIST v.1.1 [defined as > 20% increase from smallest sum of longest diameter recorded since treatment started (best response)], or death due to any cause, whichever is first.|Baseline to Measured PD or Death from Any Cause (Up to 30.3 weeks)|FAS: all enrolled participants who received at least one dose of the study drug. 8 participants were censored.||Weeks||90% Confidence Interval|Median
653524|NCT01982435|Primary|Number of Participants With Severe Ocular Adverse Events|As identified by eye examination (including visual acuity testing), identified by physical examination, subject reporting, and changes in vital signs.|12 months|||Participants|||Count of Participants
653488|NCT01983878|Primary|Percentage of Participants Who Are Progression-Free at 12 Weeks (Progression-Free Survival [PFS] Rate at 12 Weeks)|The 12-week PFS rate is the probability of participants who survived during the first 12 weeks in the study without disease progression. It was estimated using the Kaplan-Meier method for the main analysis of the 12-week PFS rate.|12 Weeks|Full Analysis Set (FAS): all enrolled participants who received at least one dose of the study drug. 8 participants were censored.||Percentage of Participants||90% Confidence Interval|Number
653489|NCT01983839|Primary|Area Under the Free Concentration-time Curve (fAUC0-24)|"The moxifloxacin plasma concentration-time profiles were described with a one compartment model with first-order absorption and elimination rate. The model estimated median values of fAUC0-24 for the current study population were reported.
fAUC0-24 were divided by the ECOFF MIC for S. pneumoniae (0.5 mg/L), H. influenzae (0.125 mg/L) and L. pneumophilia (1.0 mg/L)"|The second day of Moxifloxacin treatment|The model estimated median values of fAUC0-24 for the current study population were32.78 mg.hr/L (IQR 22.75; 47.31). respectively.||mg.hr/L||Inter-Quartile Range|Median
653490|NCT01983839|Primary|Total Peak Plasma Concentration (Cmax)|"The moxifloxacin plasma concentration-time profiles were described with a one compartment model with first-order absorption and elimination rate. The model estimated median values of total Cmax for the current study population were reported.
Each individual model predicted Cmax were divided by the ECOFF MIC for S. pneumoniae (0.5 mg/L), H. influenzae (0.125 mg/L) and L. pneumophilia (1.0 mg/L)"|The second day of Moxifloxacin treatment|||mg/L||Inter-Quartile Range|Median
653491|NCT01983787|Secondary|MIC of Pathogen Detected in Sputum Sample, Prior to Initiation of Treatment.|MIC to piperacillin/tazobactam was obtained by using E-tests (AB Biodisk, Solna, Sweden) on Mueller-Hinton agar plates incubated at 35 ± 2 degrees Celcius with inoculum, incubation time and atmosphere in accordance to the E-test application guide.|Sputum sample was collected 3 to 7 days before treatment initiation.|||mg/L|||Number
653492|NCT01983787|Secondary|The Time Above the Minimum Inhibitory Concentration (T>MIC)|"The time, expressed in percentage, for which the plasma concentration of Piperacillin lies above the minimum inhibitory concentration for the pathogen,during the treatment. If the piperacillin concentration at all measurements during the treatment period was at a level above the MIC, T>MIC is reported as 100%. MIC for the pathogen in sputum was not reported in patient 5. Therefore,T>MIC for this patient could not be estimated.
Patient 1-5 were treated with piperacillin 16g/day. Patient 6-10 were treated with piperacillin 12g/day."|Patients will be followed for the duration of treatment, which is approximately 2 weeks.|||% of time above the MIC|||Number
653493|NCT01983787|Primary|Blood-plasma Concentration of Piperacillin|"The free, non-protein bound fraction of plasma piperacillin for each patient was determined using Ultra High Performance Liquid Chromatography. The concentration was compared to the MIC-value (Minimal Inhibitory Concentration) of the pathogen isolated in a sputum sample collected prior to initiation of antibiotic treatment.
Infusion pumps with 16 g of piperacillin per 24 hours were initially used and five patients had piperacillin plasma-concentrations monitored during this treatment regimen. However, in three of these patients, the piperacillin plasma concentrations were unexpectedly low and dropped to a level below the MIC. This was found to be due to antibiotic crystallization within the infusion pumps as a result of the antibiotic concentration being too high. Consequently, infusion pumps with 12 g of piperacillin per 24 hours were used in stead. The median piperaillin concentrations reported below are derived from all measurements within the two weeks of treatment."|Piperacillin plasma-concentration was determined 3-5 times for each patient, during the 2 weeks of piperacillin treatment|||mg/L||Inter-Quartile Range|Median
653494|NCT01983566|Secondary|AUC(0-inf)|Area under the concentration-time curve of deleobuvir in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf)|1 hour (h) before drug administration and 30 minutes (min), 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h and 48h after drug administration|PKS - Due to premature discontinuation of the study, this endpoint was not evaluated.|||||
653495|NCT01983566|Primary|Cmax|Maximum measured concentration of deleobuvir in plasma (Cmax)|1 hour (h) before drug administration and 30 minutes (min), 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h and 48h after drug administration|PKS||nmol/L||Geometric Coefficient of Variation|Geometric Mean
653496|NCT01983566|Primary|AUC(0-tz)|Area under the concentration-time curve of deleobuvir in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)|1 hour (h) before drug administration and 30 minutes (min), 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h and 48h after drug administration|Pharmacokinetic set (PKS): included all subjects in the Treated Set who provided at least 1 observation for at least 1 primary pharmacokinetic (PK) endpoint that was not affected by important protocol violations relevant to the evaluation of PK.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
653497|NCT01983254|Other Pre-specified|Total Weeks at Home Post-randomization|here reported as weeks (instead of days) not at home for simplicity|over 6 months follow up|patients||weeks not at home during follow up|weeks|Standard Deviation|Mean
653498|NCT01983254|Secondary|Impact of Events Scale-revised (IES-R) Score|The IES-R evaluates subjective distress caused by traumatic events and assesses manifestations of post-traumatic stress disorder (PTSD) or acute stress disorder. It is not diagnostic but possesses excellent reliability and validity for manifestations of PTSD. The IES-R has three subscales (eight items on intrusion, eight items on avoidance, and six items on hyperarousal). Each item is scored on a four point scale: 0 = “not at all,” 1 = “a little bit,” 2 = “moderately often,” 3 = “quite a bit,” and 4 = “extremely often.” The total score of each subscale may be averaged and a cumulative score of 30 is indicative of the presence of PTSD. The maximum score for each subscale is 32 for intrusion, 32 for avoidance, and 24 for hyperarousal. The minimum cumulative score is 0 and the maximum cumulative score possible is 88.3 months post-randomization is main time point while The 3 month IES-R score will be the primary analysis, though 6 month changes will be tested as well.|3 & 6 months post-randomization|Patients who completed the IES-R scale at 3 & 6 months post-randomization.||units on a scale (IES-R)||Standard Error|Mean
653513|NCT01982539|Primary|To Confirm the Safety and Tolerability of Zipsor® in Pediatric Subjects, Ages 12 to 17 Years|"Safety Endpoints:
Treatment emergent AEs (TEAEs)
Serious adverse events (SAEs)
Withdrawals due to AEs
Deaths
Observed values and changes in vital sign measurements
Observed values and changes in clinical laboratory results
Physical examination findings"|First dose to 30 days after the last dose|The Safety population included all subjects who received at least 1 dose of the study drug.||participants|||Number
653499|NCT01983254|Primary|Hospital Anxiety and Depression Scale Score|Hospital Anxiety and Depression Scale (HADS) questionnaire: The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The anxiety and depression subscales each range from 0 to 21, with higher scores indicating higher anxiety/depression complains. Patients were defined as having anxiety or depression or both if the score was 8 or more in the corresponding subscale. The 3 month measure is primary outcome timing, though changes at 6 months will be tested as well|3 & 6 months post-randomization|Patients who completed the HADS scale at 3 & 6 months post-randomization.||units on a scale (HADS summary score)||Standard Error|Mean
653500|NCT01983111|Secondary|Patient Global Impressions of Change(PGIC)|"In the PP set, Number of participants with categorical change in overall satisfaction.
PGIC: a participant-rated instrument assessing change in participant's overall satisfaction from baseline, on a scale ranging from 1 (very much improved) to 7 (very much worse)."|6 weeks|Per protocol set: Analyze the within-group change in the PGIC from Baseline (Week 0) to Week 6 by using a paired t-test, and analyze the between-group difference in the change of satisfaction by using a t-test.||Scores on 1 to 7point||Standard Deviation|Mean
653501|NCT01983111|Secondary|Clinical Global Impression of Change(CGIC)|The number of patients who choose the best opinion of overall satisfaction among Clinical Global Impression of Change Scale(CGIC) among 7 point scale. Missing data was imputed by LOCF. Scores measure from 1: Very much improved to 7:very much worse.|6 weeks|In the per protocol: Analyze the within-group change in the CGIC from Baseline (Week 0) to Week 6 of the investigational product administration by using a paired t-test, and analyze the between-group difference in the change of satisfaction by using a t-test.||Scores on 1 to 7 point||Standard Deviation|Mean
653502|NCT01983111|Secondary|Change From Baseline in Health-related Quality of Life Assessed by EuroQol Visual Analog Scale (EQ-5D VAS)|The EQ VAS records the respondent’s self-rated health on a vertical, visual analogue scale where the endpoints are labelled ‘Best imaginable health state’ (score = 100) and ‘Worst imaginable health state’ (score = 0). Higher points were positive results and positive points of difference gap means improvement results.|Baseline and at 6weeks|In the PP set, the change in the your today health score from Visit 1 (Baseline) to Week 6 of the investigational product administration was analyzed.||scores on a scale||Standard Deviation|Mean
653503|NCT01983111|Secondary|Change in the Quality of Life (EQ-5D) Score From Visit 1 (Baseline) to Week 6 Post-dose|"EQ-5D to measure of health related quality of life should be answered as one of 3 levels about current condition for 5 dimensions for ‘Motor capability’, ‘Self-care’, ‘Daily activities’, ‘Pain/discomfort’, ‘Depression/anxiety’ and was calculated total average by giving a weighting on 3 level of answers (EQ-5D levels into 'no problems' (level 1) and 'problems' (level 2 and 3)).
*EQ-5D Total = 1 - 0.081 - (the score of the each level) - 0.269 (if at least one of level 3 presents)
EQ-5D total score could be 0.919 in maximum and -0.594 in minimum if case all index indicates the level 3. So, if EQ-5D total score closed by “1” means that the healthy condition and high quality of life."|Baseline and at 6 weeks|In the PP set, the change in the quality of life (EQ-5D) total score from Visit 1 (Baseline) to Week 6 of the investigational product administration was analyzed.||EQ-5D Total score||Standard Deviation|Mean
653504|NCT01983111|Secondary|Change in the Pain Intensity Score (0-10 NRS) From Visit 1 (Baseline) to Week 2 of the Investigational Product Administration|NRS-Pain scale assessed the severity of a subject's pain of mean pain over the past 24 hours prior to the visit on a scale of 0 (No pain) and 10 (Worst possible pain). Change = mean score at Week 2/ET minus mean score at Baseline.|2 weeks|In the PP set, the reduction in the pain intensity score from Visit 1 (Baseline) to Week 2 of the investigational product administration was analyzed.||Scores on a scale||Standard Deviation|Mean
653505|NCT01983111|Primary|Change in the Pain Intensity Score (0-10 NRS) From Visit 1 (Baseline) to 6weeks After Treatment.|NRS-Pain scale assessed the severity of a subject's pain of mean pain over the past 24 hours prior to the visit on a scale of 0 (No pain) and 10 (Worst possible pain). Change = mean score at Week6/ET minus mean score at Baseline.|baseline and 6 weeks|In the PP set, the change in the pain intensity score from Visit 1 (Baseline) to Week 6 of the investigational product administration was analyzed.||Scores on a scale||Standard Deviation|Mean
653506|NCT01983020|Primary|Pain Intensity|The primary outcome will be average pain intensity at rest on postoperative day 1 - 3. Pain Intensity rated from 0 (none) to 10 (severe).|postoperative day 1 - 3|||units on a scale||Standard Deviation|Mean
653507|NCT01982812|Secondary|Sequelae|"Neurologic outcome in 3 categories--
Neurologically intact at discharge
Neurologic sequelae at discharge--specifically new sensory or motor deficits, ongoing seizures, or behavioral abnormalities based upon a physician examination at discharge
Died during admission, never discharged"|7 days|||participants|||Number
653508|NCT01982812|Secondary|Mean Time From Admission to BCS >/= 4|"The mean time in hours from admission until the subject reaches Blantyre Coma Scale of greater than or equal to 4. Participants who died are excluded from this analysis.
The Blantyre Coma Score has ranges from 0-5 based upon the a sum of the following 3 domains- Eye movement
1 - Watches or follows 0 - Fails to watch or follow
Best motor response 2 - Localizes painful stimulus 1 - Withdraws limb from painful stimulus 0 - No response or inappropriate response
Best verbal response 2 - Cries appropriately with pain, or, if verbal, speaks
1 - Moan or abnormal cry with pain 0 - No vocal response to pain"|7 days|Comparing mean time to coma resolution in hours among survivors||hours of coma from admission||Standard Deviation|Mean
653509|NCT01982812|Secondary|Required Additional AED|Additional AEDs required (including for breakthrough seizures in LVT group) during admission for seizure control (yes/no)|7 days|||Participants requiring additional AEDs|||Number
653510|NCT01982812|Primary|Minutes With Seizure on EEG|Comparing LVT to standard AED the number of minutes spent in seizure per cEEG in the 72 hours after treatment allocation.|72 hours|||minutes with seizure||Standard Deviation|Mean
653511|NCT01982695|Primary|Cardiac Ejection Fraction as Measured by Echocardiogram|Mean cardiac ejection fraction as measured by echocardiogram at 12 month study visit. Cardiac ejection fractions were measured using the biplane Simpson’s rule using images obtained from the apical 4 chamber views of the heart.|12 month visit|All patients that received a 12 month echocardiogram evaluation||percentage of blood leaving the heart||Standard Deviation|Mean
653512|NCT01982539|Secondary|Efficacy|To determine efficacy by assessing percent changes of the Numeric Pain Rating Scale (NPRS) pain score from baseline to (1) the first hour and (2) the second hour after the first dose of Zipsor® administration.|From Baseline to 1st and 2nd hour||||||
653525|NCT01982435|Primary|Number of Participants With Non-severe Ocular Adverse Events|As identified by eye examination (including visual acuity testing), identified by physical examination, subject reporting, and changes in vital signs. These outcome measures are also included in more detail in the adverse event section of the results.|12 months|Patients who exited the study early were accounted by using a last observation carried forward approach.||Participants|||Count of Participants
653526|NCT01982292|Secondary|Pharmacokinetics of RLX030: Clearance of Serelaxin (CL)|Clearance (CL) was calculated using concentration at steady state (Css) and the actual delivered dose rate. n: Number of patients with valid PK parameters available within 48 hours post each infusion.|48 hours post each infusion|PK analysis set (PK) - All patients with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received any study drug and experienced no protocol deviations with relevant impact on PK data.||mL/hr/kg||Standard Deviation|Mean
653527|NCT01982292|Secondary|Pharmacokinetics of RLX030: Cmax Steady State (Cmaxss) Concentration at 48 Hours|This analysis was not done due to sparse PK sampling.|48 hours post each infusion|Due to sparse PK sampling, this analysis was not done.|||||
653528|NCT01982292|Secondary|Pharmacokinetics of RLXL030: Actual Concentrations at Steady State (Css)|Concentration at steady state (Css) was estimated using C48 or C24 for patients who received the intended rate of infusion for at least 24hours. n: Number of patients with valid PK parameters available|pre-infusion and 24, 48 hours post each infusion|PK analysis set (PK) - All patients with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received any study drug and experienced no protocol deviations with relevant impact on PK data.||ng/ml||Standard Deviation|Mean
653529|NCT01982292|Secondary|Pharmacokinetics of RLX030: Area Under the Plasma Concentration Time Curve From Time Zero up to 48 Hours Post Dose (AUC 0-48)|Due to sparse PK sampling, AUC 0-48 hours was not analyzed.|pre-infusion and 8, 24 and 48 hours post each infusion.|Due to sparse PK sampling, this analysis was not done.|||||
653530|NCT01982292|Secondary|Number of Participants With Adverse Events Such as Adjudicated Potential Hypersensitivity or Infusion Reactions|Incidence rate of special interest, indicative of hypersensitivity reactions which occur during and after administration of repeated infusions of serelaxin relative to placebo in subjects with chronic heart failure is reported. Hypersensitivity reactions or infusion reactions can be headache, nausea, fever, chills, dizziness, flush, pruritus, chest and/or back pain.|16 weeks|Safety set (SAF) - All patients who received at least one dose of study drug and had at least one post-Baseline safety assessment.||Participants|||Number
653531|NCT01982292|Secondary|Percentage of Participants With Chronic Heart Failure With Positive Antibody Status Who Develop Non-neutralizing Anti-serelaxin Antibodies Following 3 Repeated Infusions (i.e. at Week 4, Week 8, and Week 12)|"A patient is considered antibody positive during the study if he/she had at least two infusions and had at least one evaluable measurement to test for anti-serelaxin antibodies after each infusion and all evaluable antibody test results were positive.
n = the total number of subjects with evaluable antibody status after specified number of infusions"|At Week 4, Week 8, Week 12|All patients who received at least one dose of study drug and had at least one post-Baseline safety assessment||Percentage of participants||90% Confidence Interval|Number
653532|NCT01982292|Secondary|Antibody Titers in Participants With Chronic Heart Failure Who Develop Positive Anti-serelaxin Antibodies (Neutralizing, Non-neutralizing or Both) at Any Time Following 3 Repeated Infusions and at Week 4, Week 8 and Week 12||Week 4, Week 8, Week 12|Safety set:All patients who received at least one dose of study drug and had at least one post-Baseline safety assessment||In international Units||Standard Deviation|Mean
653533|NCT01982292|Secondary|Percentage of Participants With Chronic Heart Failure Who Develop Positive Anti-serelaxin Antibodies After a Single Infusion of Serelaxin Over Time up to Week 16|A patient is considered antibody positive during the study if he/she had at least two infusions and had at least one evaluable measurement to test for anti-serelaxin antibodies after each infusion and all evaluable antibody test results were positive. Each time period is defined as the time frame from study drug initiation (or the visit if there is no infusion) to prior to study drug initiation of the next period (or the visit if no there is no infusion). n= The total number of subjects with evaluable antibody status during the defined period.|Randomization to Week 4, Week 4 to Week 8, Week 8 to Week 12, week 12 to week 16|All patients who received at least one dose of study drug and had at least one post-Baseline safety assessment.||Percentage of patients||90% Confidence Interval|Number
653534|NCT01982292|Primary|Percentage of Participants With Chronic Heart Failure (CHF) Who Develop Anti-serelaxin Antibodies at Any Time Following Repeat Administration of IV Continuous Infusions of Serelaxin Administered for up to 48 Hours in 16 Weeks|"A patient is considered antibody positive during the study if he/she had at least two infusions and had at least one evaluable measurement to test for anti-serelaxin antibodies after each infusion and all evaluable antibody test results were positive.
A patient is considered antibody negative during the study if he/she had at least two infusions and had at least one evaluable measurement to test for anti-serelaxin antibodies after each infusion and all evaluable antibody test results were negative. A patient’s antibody status is considered to be undetermined during the study if it is not defined as positive or negative."|16 weeks|Safety Set: All patients who received at least one dose of study drug and had at least one post-Baseline safety assessment. In this reported analysis, patients with undetermined antibody status are excluded from analysis population||Percentage of participants||90% Confidence Interval|Number
653535|NCT01982253|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12|The change between the FPG value collected at week 12 or final visit relative to baseline.|Baseline and Week 12|In accordance with the SAP, due to the limited enrollment at the time of study termination, the summaries and statistical analyses of primary and secondary efficacy parameters originally intended and described in the protocol were not produced.|||||
653536|NCT01982253|Primary|Change From Baseline in HbA1c at Week 12.|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 or final visit relative to baseline.|Baseline and Week 12|In accordance with the SAP, due to the limited enrollment at the time of study termination, the summaries and statistical analyses of primary and secondary efficacy parameters originally intended and described in the protocol were not produced.|||||
653962|NCT01972776|Secondary|Observed Maximum Plasma Concentration Following Drug Administration (Cmax) (Part 1)|Venous blood samples were collected for concentration-time profiles.|day 1 (from pre-dose to 12 hours post dose)|All Part 1 participants who received active treatment.||ng/mL||Standard Deviation|Mean
653537|NCT01981967|Secondary|Number of Participants Experiencing Adverse Events of Special Interest Within 60 Days Following Vaccination With IMOJEV®|Adverse Events of Special Interest (AESIs) included hypersensitivity/allergic reactions, neurological events (including febrile convulsions), and vaccine failure.|Day O up to Day 60 post-vaccination|Safety outcome were assessed in subjects who had received the study vaccine, the Safety Analysis Set||Participants|||Number
653538|NCT01981967|Primary|Number of Participants Experiencing Serious Adverse Events By Age Following Any Vaccination With IMOJEV®||Day O up to Day 60 post-vaccination|Safety outcome were assessed in subjects who had received the study vaccine, the Safety Analysis Set||Participants|||Number
653539|NCT01981967|Primary|Number of Participants Experiencing a Grade 3 Immediate Systemic Adverse Events and Serious Adverse Events Following Any Vaccination With IMOJEV®||30 minutes post-vaccination up to Day 60 post-vaccination|Safety outcome were assessed in subjects who had received the study vaccine, the Safety Analysis Set||Participants|||Number
653540|NCT01981863|Other Pre-specified|Length of Time Between Incision and Cardiopulmonary Bypass|Mean Length of Time from Incision to Cardiopulmonary Bypass|From incision to bypass, up to 3 hours|||Minutes||Standard Deviation|Mean
653541|NCT01981863|Secondary|Value of Thromboelastography as Monitor of Fibrinolysis|Thromboelastography may display if fibrinolysis is present|6 months|||percentage of clot||Full Range|Median
653542|NCT01981863|Primary|Di-Dimer Increase Before Cardiopulmonary Bypass|Change in Di-dimer between preoperative value and value immediately before cardiopulmonary bypass in cardiac surgery patients.|6 months|D-Dimer from preoperative value and value immediately before cardiopulmonary bypass in cardiac surgery patients||ng/mL||Full Range|Median
653543|NCT01981616|Secondary|Number of Participants With Adverse Events (AEs)|"An AE was defined as any untoward medical occurrence in a subject administered a pharmaceutical product; the untoward medical occurrence did not necessarily have a causal relationship with this treatment.
Serious adverse event (SAE) meant any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of an existing hospitalization, resulted in persistent or significant disability or incapacity, was a congenital anomaly/birth defect or was a medically important event. Relationship of each AE to study drug was determined by the Investigator."|From the first dose of study medication through Day 127|The Safety Population was defined as all participants who received any amount of study drug (vedolizumab or placebo) based on what they actually received.||participants|||Number
653544|NCT01981616|Secondary|Anti-Hepatitis B Surface Antibody Over Time||Baseline and Days 18, 32, 60 and 74|"Per Protocol Population; n indicates the number of participants with available data at each time point."||IU/L||Geometric Coefficient of Variation|Geometric Mean
653545|NCT01981616|Secondary|Percentage of Participants With an Immune Response to Oral Cholera Vaccine|A positive immune response was defined as an increase of greater than 4-fold over the Baseline immunoglobulin M (IgM), IgG, or IgA anticholera antibodies.|Baseline and Day 74|The Dukoral Population was defined as all participants who had evaluable samples for assessing immune response to cholera vaccine (Dukoral) vaccine at any visit.||percentage of participants||95% Confidence Interval|Number
653546|NCT01981616|Primary|Percentage of Participants With an Immune Response to Hepatitis B Vaccine at Day 74|Immune response was defined as hepatitis B surface antibody (anti-HBs) ≥ 10 IU/L.|Day 74|The Per Protocol Population consisted of all participants who received any amount of study drug and who met predefined evaluability criteria, including receiving the correct and complete dose of study drug, completed both Baseline and day 72 serology assessments and full schedule of hepatitis B vaccine and immunomodulator or corticosteroid use.||percentage of participants||95% Confidence Interval|Number
653547|NCT01981473|Secondary|Correlation of Antidrug Antibody Titers With Trough Drug Concentration.|Correlation of antidrug antibody titers with trough drug concentration analysed using Spearman correlation coefficient.|1 day|FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit. No participants for etanercept arm were antibody positive, therefore there is no correlation to report.||Correlation coefficient|||Number
653548|NCT01981473|Secondary|Correlation of Antidrug Antibody Titers With Efficacy Measures.|Correlation of antidrug antibody titers with efficacy measures analysed using Spearman correlation coefficient.|1 day|FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit. No participants for etanercept arm were antibody positive, therefore there is no correlation to report.||Correlation coefficient|||Number
653549|NCT01981473|Secondary|Percentage of HAQ DI (<=0.5) Scores for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.|HAQ DI (<=0.5) scores for etanercept, adalimumab, or infliximab compared between participants who are antidrug antibody positive versus negative.|1 day|FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit.||percentage of participants|||Number
653550|NCT01981473|Secondary|Health Assessment Questionnaire-Disability Index (HAQ DI) Scores for for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.|The HAQ-DI assesses the degree of difficulty a participant has experienced during the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2-3 items. For each question in the questionnaire, the level of difficulty is scored from 0 to 3 with 0 representing “no difficulty,” 1 as “some difficulty,” 2 as “much difficulty,” and 3 as “unable to do.” Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. The total score range for the HAQ-DI scale, minimum score was 0 (best), maximum score was 3 (worst).|1 day|FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit.||Units on a scale||Standard Deviation|Mean
653560|NCT01981356|Secondary|Experimental Treatment Acceptability|Assessed by patient reported treatment satisfaction, as assessed by the well-validated Client Satisfaction Questionnaire - 8 (CSQ-8; Attkisson & Zwick, 1982; range 0 to 5, higher scores indicate better outcome).|Participants were followed for the duration of hospital stay (Mean = 24.0 days, SD = 15.8).|||units on a scale||Standard Deviation|Mean
653551|NCT01981473|Secondary|Disease Activity Score, 28 Joint Count, Calculated With C-reactive Protein (DAS28-CRP) for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.|The DAS28 assessment is a derived measurement with differential weight given to each component. DAS28 will be calculated twice, utilizing first ESR, and then CRP as the acute phase reactant: 1) DAS28-ESR = 0.56 sqrt (28 painful/tender joint count) + 0.28 sqrt (28 swollen joint count) + 0.70 (ln ESR) + 0.014 GH, where GH=subject general health VAS (0 100 mm). 2) DAS28-4 CRP = 0.56 sqrt (28 painful/tender joint count) + 0.28 sqrt (28 swollen count) + 0.36 (ln CRP+1) + 0.014 GH + 0.96, where GH=subject general health VAS (0-100 mm), higher scores were indicative of a worse outcome. The specific components of the DAS28 assessment that were used in this study are: Tender/Painful Joint Count (28), Swollen Joint Count (28), ESR/CRP, and Subject’s General Health VAS assessment.|1 day|FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit.||Units on a scale||Standard Deviation|Mean
653552|NCT01981473|Secondary|Disease Activity Score Based on a 28-joint Count (DAS28), Calculated With Erythrocyte Sedimentation Rate for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.|The DAS28 assessment is a derived measurement with differential weight given to each component. DAS28 will be calculated twice, utilizing first ESR, and then CRP as the acute phase reactant: 1) DAS28-ESR = 0.56 sqrt (28 painful/tender joint count) + 0.28 sqrt (28 swollen joint count) + 0.70 (ln ESR) + 0.014 GH, where GH=subject general health VAS (0-100 mm). 2) DAS28-4 CRP = 0.56 sqrt (28 painful/tender joint count) + 0.28 sqrt (28 swollen count) + 0.36 (ln CRP+1) + 0.014 GH + 0.96, where GH=subject general health VAS (0- 100 mm), higher scores were indicative of a worse outcome. The specific components of the DAS28 assessment that were used in this study are: Tender/Painful Joint Count (28), Swollen Joint Count (28), ESR/CRP, and Subject’s General Health VAS assessment.|1 day|FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit.||Units on a scale||Standard Deviation|Mean
653553|NCT01981473|Secondary|The Simplified Disease Activity Index (SDAI) Total Scores for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.|The SDAI Total Scores for etanercept, adalimumab, or infliximab compared between participants who are antidrug antibody positive versus negative. SDAI = DAS 28 prorated Swollen Joint Count (0-28) + DAS 28 prorated Tender Joint Count (0-28) + Physician’s Global Assessment (0-10) + Subject’s Global Assessment (0-10) + C-reactive protein (CRP) (in mg/dL). The total score range is 0-86. Score interpretation: Remission SDAI ≤ 3.3; Low Disease Activity SDAI > 3.3 and ≤ 11; Moderate Disease Activity SDAI > 11 and ≤ 26; High Disease Activity SDAI > 26.|1 day|FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit.||units on a scale||Standard Deviation|Mean
653554|NCT01981473|Secondary|The Clinical Disease Activity Index (CDAI) Total Scores for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.|The CDAI total scores for etanercept, adalimumab, or infliximab compared between participants who are antidrug antibody positive versus negative. CDAI = Disease activity score (DAS) 28 prorated Swollen Joint Count (0-28) + DAS 28 prorated Tender Joint Count (0-28) + Physician’s Global Assessment (0-10) + Subject’s Global Assessment (0-10). The total score range is 0-76. Score interpretation: Remission ≤ 2.8; Low Disease Activity CDAI > 2.8 and ≤ 10; Moderate Disease Activity CDAI > 10 and ≤ 22; High Disease Activity CDAI > 22.|1 Day|FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit.||units on a scale||Standard Deviation|Mean
653555|NCT01981473|Secondary|Percentage of Participants Positive for Antidrug Antibodies Among Those Treated With Etanercept, Adalimumab, or Infliximab.|Percentage of participants positive for antidrug antibodies among those treated with etanercept, adalimumab, or infliximab were determined.|1 Day|FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit.||Percentage of participants|||Number
653556|NCT01981473|Secondary|Serum Trough Drug Concentrations for Etanercept, Adalimumab, and Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.|Serum trough drug concentrations for etanercept, adalimumab, and infliximab compared between participants who are antidrug antibody positive versus negative. Units of measurement for Serum trough drug concentration is µg/mL.|1 day|FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit.||µg/mL||Standard Deviation|Mean
653557|NCT01981473|Secondary|Percentage of Participants With Low Disease Activity (LDA) (DAS28 ESR Score ≤ 3.2) Among Those Who Are Antidrug Antibody Positive Versus Negative (All Patients Receiving Etanercept, Adalimumab, or Infliximab Combined).|Percentage of participants with Low Disease Activity (LDA) (Disease Activity Score based on a 28-joint count [DAS28] Erythrocyte sedimentation rate [ESR] score ≤3.2) among those who are antidrug antibody positive versus negative (all participants receiving etanercept, adalimumab, or infliximab combined).|1 day|FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit.||percentage of participants|||Number
653558|NCT01981473|Primary|Percentage of Participants Positive for Antidrug Antibodies Among Those Treated With Etanercept Versus Those Treated With Monoclonal Antibodies (Adalimumab or Infliximab).|Percentage of participants positive for antidrug antibodies among those treated with etanercept versus those treated with monoclonal antibodies (adalimumab or infliximab) was determined.|1 day|FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit.||Percentage of participants|||Number
653559|NCT01981356|Secondary|Experimental Treatment Acceptability|Assessed by patient reported therapeutic alliance, measured by the well-validated Working Alliance Inventory (WAI; Horvath & Greenberg, 1989; range 1 to 7, higher score indicated better outcome).|Participants were followed for the duration of hospital stay (Mean = 24.0 days, SD = 15.8).|||units on a scale||Standard Deviation|Mean
653561|NCT01981356|Secondary|Experimental Treatment Safety|Assessed by the occurrence of zero adverse events attributable to ACT.|8-month study period|Although 18 participants were randomized to treatment condition, the consent of two participants was invalid. Thus, their data could not be utilized and is not reported other than for identification of participant flow.||adverse events|||Number
653562|NCT01981356|Secondary|Experimental Treatment Acceptability|Assessed by patient attendance of at least 3 out of 4 sessions on average.|8-month study period|||sessions||Standard Deviation|Mean
653563|NCT01981356|Secondary|Experimental Treatment Feasibility|Assessed by our ability to recruit and consent 2 eligible participants per week (for 40 weeks) to participate in random assignment to ACT + TAU or TAU.|8-month study period|Although 18 participants were randomized to treatment condition, the consent of two participants was invalid. Thus, their data could not be utilized and is not reported other than for identification of participant flow.||participants|||Number
653564|NCT01981356|Secondary|Barriers and Facilitators to Implementation|We will conduct 30-60 minute semi-structured interviews structured around the RE-AIM framework (Glasgow et al., 1999), and utilizing the RE-AIM Planning Tool (Forman et al., 2010). The RE-AIM framework identifies, for example, barriers that limit patients, staff, and site participation in the intervention and how to address them, and provider and patient perceptions about why the intervention is successful at achieving better outcomes.|8-month study period|Data regarding barriers and facilitators was not obtained from patient participants, but was obtained from study staff, who were not assigned to treatment condition.||Participants providing data|||Number
653565|NCT01981356|Secondary|Cost of Stay|Obtained by: (a) obtaining length obtained by: (a) obtaining length-of-stay (in hours) on the inpatient unit for all study participants, (b) calculating the cost of stay for each participant by multiplying the length-of-stay by the dollar amount associated with inpatient treatment of psychosis (e.g., $1,297/day or $54/hour in 2011; Blow et al., 2011), and (c) summing the cost of stay across participants in each treatment condition.|Participants were followed for the duration of hospital stay (Mean = 24.0 days, SD = 15.8).|Data regarding length of stay not available for one participant in each condition, both of whom had not been discharged by the end of the study period.||Dollars||Standard Deviation|Mean
653566|NCT01981356|Secondary|Positive and Negative Affect Scale (Watson et al., 1988)|Assesses short-term changes in global positive and negative affect in addition to changes in specific types of emotions (e.g., afraid, excited, guilty). Positive and negative affect subscales consist of ten items each, averaged to obtain scale scores. Scale scores are reported as percentage of total possible change, calculated as follow-up score minus baseline score divided by total points in scale. Minimum score is -100% change (a decrease of 100% of total possible score from baseline to follow-up assessment). Minimum score is akin to a change from the highest (5) to lowest (1) possible value on scale from baseline to follow-up. Maximum score is +100% change (an increase of 100% of total possible score from baseline to follow-up assessment). Maximum score is akin to a change from the lowest (1) to highest (5) possible value on scale from baseline to follow-up. Increases in positive affect percentage change and decreases in negative affect change are considered better outcomes.|Participants were followed for the duration of hospital stay (Mean = 24.0 days, SD = 15.8).|||percentage of total possible change||Standard Deviation|Mean
653567|NCT01981356|Secondary|Acceptance and Action Questionnaire - II (Bond et al.., 2011)|Assesses changes in the primary mechanism thought to contribute to change in ACT: acceptance. All scale items were averaged to obtain a total scale score. Total scale scores are reported as percentage of total possible change, calculated as follow-up score minus baseline score divided by total points in scale. Minimum score is -100% change (a decrease of 100% of total possible score from baseline to follow-up assessment). Minimum score is akin to a change from the highest (7) to lowest (1) possible value on scale from baseline to follow-up. Maximum score is +100% change (an increase of 100% of total possible score from baseline to follow-up assessment). Maximum score is akin to a change from the lowest (1) to highest (7) possible value on scale from baseline to follow-up. Increases in percentage change are considered better outcomes (i.e., increased acceptance).|Participants were followed for the duration of hospital stay (Mean = 24.0 days, SD = 15.8).|Out of participants who completed follow-up assessments, one participant in each condition did not complete the Acceptance and Action Questionnaire - II.||percentage of total possible change||Standard Deviation|Mean
653568|NCT01981356|Secondary|Frequency, Believability, and Distress Symptom Scale (Gaudiano & Herbert, 2006)|Assesses changes in the frequency, believability, and associated distress of psychosis symptoms. Frequency, believability, and distress subscales consist of two items each, one assessing delusions and one assessing hallucinations, averaged to obtain subscale scores. Subscale scores are reported as percentage of total possible change, calculated as follow-up score minus baseline score divided by total points in scale. Minimum score is -100% change (a decrease of 100% of total possible score from baseline to follow-up assessment). Minimum score is akin to a change from the highest to lowest possible value on scale from baseline to follow-up. Maximum score is +100% change (an increase of 100% of total possible score from baseline to follow-up assessment). Maximum score is akin to a change from the lowest to highest possible value on scale from baseline to follow-up. Decreases in percentage change are considered better outcomes (i.e., reduced frequency, believability and distress).|Participants were followed for the duration of hospital stay (Mean = 24.0 days, SD = 15.8).|Out of participants who completed follow-up assessments, one participant in each condition did not complete the Frequency, Believability, and Distress Symptom Scale.||percentage of total possible change||Standard Deviation|Mean
653569|NCT01981356|Primary|Brief Psychiatric Rating Scale (Overall & Gorham, 1962)|Assesses changes in broad symptom domains (affect disturbance, positive symptoms, negative symptoms, resistance/hostility, activation) and specific symptoms (e.g., delusions). All scale items were averaged to obtain a total scale score. Scale scores are reported as percentage of total possible change, calculated as follow-up score minus baseline score divided by total points in scale. Minimum score is -100% change (a decrease of 100% of total possible score from baseline to follow-up assessment). Minimum score is akin to a change from the highest (7) to lowest (1) possible value on scale from baseline to follow-up. Maximum score is +100% change (an increase of 100% of total possible score from baseline to follow-up assessment). Maximum score is akin to a change from the lowest (1) to highest (7) possible value on scale from baseline to follow-up. Decreases in percentage change are considered better outcomes (i.e., reduced symptoms).|Participants were followed for the duration of hospital stay (Mean = 24.0 days, SD = 15.8).|||percentage of total possible change||Standard Deviation|Mean
653580|NCT01980992|Secondary|Incidence of All Serious Adverse Events During the Study.||2 Years||||||
653581|NCT01980992|Secondary|The Percentage of Subjects That Achieve Desensitization in the Placebo Cross Over Group After 1 Year of Dosing.||2 Years||||||
653582|NCT01980992|Secondary|The Percentage of Subjects Who Achieve the Targeted Maintenance Dose of Wheat OIT During the Desensitization Phase of the Study.||44 Weeks||||||
653583|NCT01980992|Secondary|The Percentage of Subjects Who Successfully Consume a 7443 mg Wheat Protein Oral Food Challenge (OFC) 8-10 Weeks After Therapy Discontinuation and After Passing the 7443 mg Wheat Protein OFC at the 2 Year Time Point.|This OFC will only be administered to subjects in the initial active treatment group.|8 to 10 weeks after passing the 2 Year OFC||||||
653584|NCT01980992|Primary|The Percentage of Desensitized Participants as Measured by the Ability to Consume at Least 4443 mg of Wheat Protein During a 7443 mg Wheat Protein Oral Food Challenge (OFC) Performed 1 Year After Initiating Treatment.|Determine in wheat allergic children, whether relative to placebo, daily oral administration of Vital Wheat Gluten escalated to a maximum of 2035 mg/day of Vital Wheat Gluten increases desensitization as measured by consuming without dose limiting symptoms 4443 mg of wheat protein on a 7443 mg wheat protein OFC performed 1 year after initiating treatment.|1 Year|All randomized participants were included.||Participants|||Count of Participants
653585|NCT01980940|Secondary|Study Parts 1 and 2: Number of Participants Who Discontinued Study Drug Due to an Adverse Event|An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.|Study Part 1: up to Day 47; Study Part 2: up to Day 28|Safety analysis set defined as all treated participants (etoricoxib or placebo) based on the treatment received rather than the randomized assignment.||Participants|||Number
653586|NCT01980940|Secondary|Study Parts 1 and 2: Number of Participants Who Experienced at Least One Adverse Event|An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.|Study Part 1: up to Day 47; Study Part 2: up to Day 28|Safety analysis set defined as all treated participants (etoricoxib or placebo) based on the treatment received rather than the randomized assignment.||Participants|||Number
653587|NCT01980940|Secondary|Study Part 2: Percentage of Participants by Category on Patient Global Assessment of Response to Therapy (PGART)|The PGART is a self-administered questionnaire completed by participants. Participant assessment of response of arthritis to study medication was assessed on a 5-point Likert scale ('very well', 'well', 'fair', 'poor', and 'very poor').|Day 2, Day 4, Day 7, Day 11, Day 14, post-trial (up to Day 28)|FAS defined as all treated participants (etoricoxib or placebo) without major entry criteria violation and with at least one valid post-baseline primary efficacy assessment||Percentage of participants|||Number
653623|NCT01979029|Primary|The Blood Pressure of the Arterial Arcade||after ligating the inferior mesentric artery or superior rectal artery|||mmHg||Standard Deviation|Mean
653588|NCT01980940|Secondary|Study Part 2: Change From Baseline in Mean Participant Score on the WOMAC VA 3.1 Physical Functioning Scale|The WOMAC VA 3.1 Physical Functioning subscale is a self-administered questionnaire assessing lower extremity physical function due to osteoarthritis that was completed by participants 2 to 3 hours post morning dose. The WOMAC Physical Functioning subscale had 17 questions with answers to each item assessed on a 100 mm VA scale (0 = no difficulty; 100 = extreme difficulty). The score for each item was summed and the overall score ranged from 0 to 1700 (increasing severity). The time weighted average up to day x was calculated as the sum of rectangles under the curve for successive intervals prior to day x as defined by timepoints at which assessments were made. The time weighted change from baseline was calculated. A negative mean change from baseline indicates improvement in physical function.|Baseline (Day -1), Day 2, Day 4, Day 7, Day 11, Day 14|FAS defined as all treated participants (etoricoxib or placebo) without major entry criteria violation and with at least one valid post-baseline primary efficacy assessment||Units on a scale||Standard Deviation|Mean
653589|NCT01980940|Secondary|Study Part 2: Change From Baseline in Mean Participant Score on the WOMAC VA 3.1 Stiffness Scale|The WOMAC VA 3.1 Stiffness subscale is a self-administered questionnaire assessing lower extremity stiffness due to osteoarthritis that was completed by participants 2 to 3 hours post morning dose. The WOMAC Stiffness subscale had two questions with answers to each item assessed on a 100 mm VA scale (0 = no stiffness; 100 = extreme stiffness). The score for each item was summed and the overall score ranged from 0 to 200 (increasing severity). The time weighted average up to day x was calculated as the sum of rectangles under the curve for successive intervals prior to day x as defined by timepoints at which assessments were made. The time weighted change from baseline was calculated. A negative mean change from baseline indicates improvement in stiffness.|Baseline (Day -1), Day 2, Day 4, Day 7, Day 11, Day 14|FAS defined as all treated participants (etoricoxib or placebo) without major entry criteria violation and with at least one valid post-baseline primary efficacy assessment||Units on a scale||Standard Deviation|Mean
653590|NCT01980940|Primary|Study Part 2: Change From Baseline in Mean Participant Score on the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Visual Analog (VA) 3.1 Pain Scale|The WOMAC VA 3.1 Pain subscale is a self-administered questionnaire assessing lower extremity pain due to osteoarthritis that was completed by participants 2 to 3 hours post morning dose. The WOMAC Pain Subscale had five questions with answers to each item assessed on a 100 mm VA scale (0 = no pain; 100 = extreme pain). The score for each item was summed and the overall score ranged from 0 to 500 (increasing severity). The time weighted average up to day x was calculated as the sum of rectangles under the curve for successive intervals prior to day x as defined by timepoints at which assessments were made. The time weighted change from baseline was calculated. A negative mean change from baseline indicates improvement in pain.|Baseline (Day -1), Day 2, Day 4, Day 7, Day 11, Day 14|Full analysis set (FAS) defined as all treated participants (etoricoxib or placebo) without major entry criteria violation and with at least one valid post-baseline primary efficacy assessment||Units on a scale||Standard Deviation|Mean
653591|NCT01980940|Primary|Study Part 1: Area Under the Concentration-time Curve of ETOR From Time 0 to Last (AUC0-last) After Single Dosing|Area under the observed concentration-time curve from time zero to the last quantifiable time point determined for the period up to 72 hours post-single application. The area was calculated according to the linear up/log down trapezoidal rule. AUC0-last is an estimate of total plasma exposure. Descriptive statistics are expressed as the GLSM. AUC with value 0 included in calculation of GLSMs with a value of 0.5*LLOQ (=0.5 h*ng/ml).|Predose and 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 12, 16, 24, 36, 48, and 72 hours post-application|PK analysis set defined as all participants treated with etoricoxib with sufficient PK data for reliable estimation of the PK parameter of interest (AUC0-last) without any protocol violation that interferes with PK data interpretation||mg||90% Confidence Interval|Least Squares Mean
653592|NCT01980940|Primary|Study Part 1: Time to Maximum Concentration (Tmax) of ETOR After Single Dosing|Tmax determined for the period up to 72 hours post-single application.|Predose and 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 12, 16, 24, 36, 48, and 72 hours post-application|PK analysis set defined as all participants treated with etoricoxib with sufficient PK data for reliable estimation of the PK parameter of interest (Tmax) without any protocol violation that interferes with PK data interpretation||hour||Full Range|Median
653593|NCT01980940|Primary|Study Part 1: Maximum Concentration (Cmax) of ETOR After Single Dosing|Cmax determined for the period up to 72 hours post-single application. Descriptive statistics are expressed as the geometric least squares mean (GLSM). Cmax with value 0 included in calculation of GLSMs with a value of 0.5*LLOQ (=0.5 h*ng/ml).|Predose and 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 12, 16, 24, 36, 48, and 72 hours post-application|PK analysis set defined as all participants treated with etoricoxib with sufficient PK data for reliable estimation of the PK parameter of interest (Cmax) without any protocol violation that interferes with PK data interpretation||mg||90% Confidence Interval|Least Squares Mean
653594|NCT01980875|Secondary|Minimal Residual Disease Negativity Rate at Week 36|Minimal residual disease (MRD) negativity rate is defined as the proportion of participants with MRD < 10^-4 assessed by flow cytometry in bone marrow at Week 36 after therapy initiation. For participants receiving the final dose of obinutuzumab after the original scheduled date, the MRD assessment was performed no less than 12 weeks after the last dose of obinutuzumab. MRD negativity rate was to be assessed by an IRC.|Up to 11 months|The study was terminated in agreement with the FDA due to urgent safety measures. Complete data were not collected for any participant.|||||
653595|NCT01980875|Secondary|Overall Survival|Overall survival is defined as the interval from randomization to death from any cause. Overall survival was to be assessed by an IRC.|Up to 11 months|The study was terminated in agreement with the FDA due to urgent safety measures. Complete data were not collected for any participant.|||||
653596|NCT01980875|Secondary|Complete Response Rate|Complete response rate is defined as the proportion of participants who achieve a confirmed complete response. Complete response rate was to be assessed by an IRC.|Up to 11 months|The study was terminated in agreement with the FDA due to urgent safety measures. Complete data were not collected for any participant.|||||
653597|NCT01980875|Secondary|Nodal Response Rate|Nodal response rate is defined as the proportion of participants who achieve a 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters of index lesions. Nodal response rate was to be assessed by an IRC.|Up to 11 months|The study was terminated in agreement with the FDA due to urgent safety measures. Complete data were not collected for any participant.|||||
653598|NCT01980875|Secondary|Overall Response Rate|Overall response rate (ORR) is defined as the proportion of participants who achieve a confirmed complete or partial response. ORR was to be assessed by an IRC.|Up to 11 months|The study was terminated in agreement with the FDA due to urgent safety measures. Complete data were not collected for any participant.|||||
653599|NCT01980875|Primary|Progression-Free Survival|Progression-free survival (PFS) is defined as the interval from randomization to the first documentation of definitive disease progression or death from any cause. Definitive disease progression is CLL progression based on standard criteria, excluding lymphocytosis alone. PFS was to be assessed by an independent review committee (IRC).|Up to 11 months|The study was terminated in agreement with the FDA due to urgent safety measures. Complete data were not collected for any participant.|||||
653600|NCT01980628|Secondary|DOR (Duration of Response)|The DOR analyses is performed on the subset of subjects that achieve CR or PR as determined by IRC. DOR is calculated as the duration of time from the date of first response to the date of progression or death due to any cause.|Analysis was conducted with the cutoff date of 05 July 2016, with a median follow-up time of 19.4 months.|||Months||95% Confidence Interval|Median
653601|NCT01980628|Primary|ORR (Overall Response Rate)|"ORR is defined as the proportion of subjects who achieved complete response (CR), partial response (PR). Response criteria are as outlined in the International Working Group Criteria for NHL, Cheson (2007), with disease assessments performed by an independent review comittee (IRC).
Per Cheson:
CR is defined as disappearance of all evidence of disease. PR is defined as regression of measurable disease and no new sites."|Analysis was conducted with the cutoff date of 05 July 2016, with a median follow-up time of 19.4 months.|||Percentage of Participants||95% Confidence Interval|Mean
653602|NCT01980589|Secondary|Number of Participants With Adverse Events|"Adverse events (AEs) were graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03 and using the following scale:
Grade 1 = Mild, Grade 3 = Moderate; Grade 3 = Severe, Grade 4 = Life-threatening; Grade 5 = Fatal."|From first dose of study drug until 30 days after last dose; median duration of treatment was 31 weeks.|Safety population||participants|||Number
653603|NCT01980589|Secondary|Time To Response (TTR)|Time to response is defined as months from treatment start to first documentation of response of partial response or better. Summary of time to response includes confirmed responders of PR or better only.|Disease response was assessed at the end of each cycle and 30 days after the last treatment; maximum treatment duration was 32 weeks.|Participants with an overall response||months||Full Range|Median
653604|NCT01980589|Secondary|Overall Response Rate (ORR)|Participants were evaluated for disease response and progression by the investigator according to the International Myeloma Working Group-Uniform Response Criteria (IMWG-URC). Disease response and progression assessments included serum protein electrophoresis (SPEP), urine protein electrophoresis (UPEP), serum immunofixation, serum free light chain (SFLC), bone marrow sample (including fluorescent in situ hybridization [FISH]), plasmacytoma evaluation, and skeletal survey. Overall response rate is defined as the percentage of participants with a best response of stringent complete response, complete response, very good partial response (VGPR), or partial response.|Disease response was assessed at the end of each cycle and 30 days after the last treatment; maximum treatment duration was 32 weeks.|Safety population||percentage of participants||95% Confidence Interval|Number
653605|NCT01980589|Primary|Number of Participants With Dose-limiting Toxicities (DLTs)|"The MTD is defined as the highest carfilzomib dose at which fewer than 33% of participants experience a treatment-related dose-limiting toxicity (DLT) during the first 28-day cycle. The number of participants who experienced a DLT is reported.
Dose-limiting toxicities are defined as any of the following carfilzomib-related adverse events:
Nonhematologic:
≥ Grade 3 non-hematological toxicity
≥ Grade 3 acute kidney injury (creatinine > 3 × baseline or > 4.0 mg/dL) lasting > 72 hours
Hematologic:
Grade 4 neutropenia (absolute neutrophil count [ANC] < 0.5 × 10^9/L) lasting for > 7 days
Febrile neutropenia (ANC < 1.0 × 10^9/L with a fever ≥ 38.3ºC) of any duration
Grade 4 thrombocytopenia (< 25 × 10^9/L) that persists for > 14 days, despite holding treatment
Grade 3 or 4 thrombocytopenia associated with > Grade 1 bleeding"|First cycle treatment over 28-days|The Safety population is defined as all enrolled participants who received any study treatment.||participants|||Number
653606|NCT01980524|Other Pre-specified|Stroke Volume|Stroke volume before and after administration of acipimox or placebo|180 minutes|||ml/m2||Standard Deviation|Mean
653607|NCT01980524|Secondary|Ejection Fraction|Left ventricular ejection fraction before and after administration of acipimox or placebo|180 minutes|||percentage||Standard Deviation|Mean
653608|NCT01980524|Primary|MYCL|Intramyocardiocellular lipid content (MYCL) before and after administration of acipimox or placebo|180 minutes|||percentage of water signal||Standard Deviation|Mean
653609|NCT01980095|Other Pre-specified|H. Pylori Eradication|The occurrence of H. pylori eradication in Placebo and Active Drug Eradication Failure Patients treated with Standard of Care (SOC) treatment|28-56 days after completion of SOC treatment|||Participants|||Count of Participants
653610|NCT01980095|Primary|The Occurrence of H. Pylori Eradication as Confirmed Via 13C UBT Testing|Modified intent-to-treat (mITT) population analyzed included all participants whok received at least 1 dose of study drug and underwent a 13C Urea Breath Test (UBT) at Visit 4. Participants with negative test results were to be considered treatment successes. Patients who tested positive for H. pylori infection, and those with indeterminate, not assessable, or missing results were to be considered treatment failures. The statistical hypothesis that the active treatment is superior to 70% was to be tested against the alternative hypothesis that the active treatment is statistically indistinguishable or less than 70% effective using a one-sample Z-test.|28-56 days after completion of treatment|||Participants|||Count of Participants
653611|NCT01979185|Primary|Maximum Plasma Concentration (Cmax) of Simvastatin|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Over 72 hours post-dose|Pharmacokinetic Set: All subjects who took at least 1 dose of investigational product and for whom the primary pharmacokinetic data were considered sufficient and interpretable.||ng/mL||Standard Deviation|Mean
653624|NCT01978743|Secondary|Change in Level of EFV and Metabolites|Correlate change in level of EFV and metabolites with neurocognitive and neuroimaging changes|week 0 and week 8|Level of EFV (efavirenz) in Atripla and its two known metabolites known to cause cerebral side effects, 7-hydroxy (OH) EFV and 8-OH EFV, were measured in the plasma prior to switch off Atripla and after 8 weeks of RAL-based regimen (no EFV).||participants|||Number
653612|NCT01979185|Primary|Area Under the Concentration-time Curve From Time Zero to the Time of the Last Measureable Concentration (AUClast) of Simvastatin|AUClast is the area under the concentration versus time curve from the time of dosing to the last measurable concentration. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Over 72 hours post-dose|Pharmacokinetic Set: All subjects who took at least 1 dose of investigational product and for whom the primary pharmacokinetic data were considered sufficient and interpretable.||ng*h/ml||Standard Deviation|Mean
653613|NCT01979185|Primary|Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) for Simvastatin|AUCinf is the area under the plasma concentration versus time curve extrapolated from time 0 to infinity, calculated using the observed value of the last nonzero concentration. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Over 72 hours post-dose|Pharmacokinetic Set: All subjects who took at least 1 dose of investigational product and for whom the primary pharmacokinetic data were considered sufficient and interpretable.||ng*h/ml||Standard Deviation|Mean
653614|NCT01979133|Primary|Change in Young Mania Rating Scale (YMRS) From Baseline to Week 8 (Exit)|"The YMRS is an 11-item observer-rated measure of mania symptomatology:
7 individual items are scored between 0-4.
4 individual items are scored between 0-8.
Total score range is 0-60, with no subscales. Higher score is indicative of more manic symptoms. Lower score represents better outcomes.
Total score is obtained by adding items on the scale together."|Baseline vs. Week 8 (Exit)|The planned enrollment was 10 participants. One participant dropped out during Baseline II visit, thus researchers were unable to assess change from baseline to week 8 in this participant. As a result, the overall number of participants included in the analysis was 9.||YMRS units on a scale||Standard Deviation|Mean
653615|NCT01979133|Primary|Change in Days of Alcohol Use From Baseline to Week 8 (Exit)|"Total score range is 0-7 (no days of alcohol use - 7 days of alcohol use). The lower score represents better outcome.
Participants are asked to identify days on which they used alcohol in the past week (not including the day of visit)."|Baseline vs. Week 8 (Exit)|The planned enrollment was 10 participants. One participant dropped out during Baseline II visit, thus researchers were unable to assess change from baseline to week 8 in this participant. As a result, the overall number of participants included in the analysis was 9.||Days Per Week||Standard Deviation|Mean
653616|NCT01979133|Primary|Change in Number of Heavy Drinking Days From Baseline to Week 8 (Exit)|"Heavy drinking day is defined as 5 standard drinks per day for men, and 4 standard drinks per day for women.
Minimum score is 0 (no drinks); maximum score is unique to each individual participant. Lower score represents a better outcome.
Average number of heavy drinking days per week is calculated by asking participants to identify the number of drinks they had on each day during the past 7 days (not including the day of visit).
See outcome measure description for standard drinks per week for standard drinks convention."|Baseline vs. Week 8 (Exit)|The planned enrollment was 10 participants. One participant dropped out during Baseline II visit, thus researchers were unable to assess change from baseline to week 8 in this participant. As a result, the overall number of participants included in the analysis was 9.||Days Per Week||Standard Deviation|Mean
653617|NCT01979133|Primary|Change in Number of Standard Drinks of Alcohol Per Week Baseline vs. Week 8 (Exit)|"Participants are asked to identify the number of alcoholic drinks they consumed on each day within the last 7 days from the day of visit (not including the day of visit). Participants are asked to provide alcohol name and the amount of alcohol they consumed. These values are then converted to standard drinks using a standard drinks calculator.
The minimum number of drinks per week is 0. There is no maximum number of drinks per week, as the maximum number is unique to each participant.
The general convention for standard drinks used in this study is as follows (oz per one standard drink):
beer: 12 fl oz (5% ABV)
wine: 5 fl oz (10-12% ABV or 18-20% ABV for fortified wine)
hard liquor: 1.5 fl oz (40% ABV)"|Baseline vs. Week 8 (Exit)|The planned enrollment was 10 participants. One participant dropped out during Baseline II visit, thus researchers were unable to assess change from baseline to week 8 in this participant. As a result, the overall number of participants included in the analysis was 9.||Drinks per week||Standard Deviation|Mean
653618|NCT01979133|Primary|Change in Quick Inventory of Depressive Symptomatology (QIDS) Score From Baseline to Week 8|"The QIDS is a 16-item self-report measure of depressive symptomatology:
16 items rated on a scale from 0-3. No subscales for this instrument.
Total score range is 0-27, where higher score represents higher levels of depression. Lower scores associated with better outcomes.
Total score is obtained using the following formula: highest score on items 1-4 + item 5 + highest score on items 6-9 + item 10+item 11+item12+item13+item14+highest score on items 15-16"|Baseline vs. Week 8 (Exit)|The planned enrollment was 10 participants. One participant dropped out during Baseline II visit, thus researchers were unable to assess change from baseline to week 8 in this participant. As a result, the overall number of participants included in the analysis was 9.||QIDS units on a scale||Standard Deviation|Mean
653619|NCT01979133|Primary|Change in Hamilton Rating Scale of Anxiety From Baseline to Week 8 (Exit)|"HAMA is a 14-item observer rated measure of anxiety symptomatology:
14 items in a scale, no subscales. Individual items are score 0 (no anxiety) to 4 (very severe anxiety).
Total scores range from 0-56.
Total scores represent more severe anxiety. Lower scores represent a better outcome."|Baseline vs. Week 8 (Exit)|The planned enrollment was 10 participants. One participant dropped out during Baseline II visit, thus researchers were unable to assess change from baseline to week 8 in this participant. As a results, the overall number of participants analyzed was 9.||HAMA units on a scale||Standard Deviation|Mean
653620|NCT01979133|Primary|Change in Hamilton Rating Scale of Depression (HAMD) From Baseline to Week 8 (Exit)|"HAMD is an observer-rated measure of depressive symptomatology:
17 questions (answers for individual questions range between 0-3 and 0-4). Total score range: 0-52. No subscales for this measure.
0 - no depression; 52 - very severe depression (lower score corresponds to a better outcome).
Total score is obtained by summing questions 1-17."|Baseline vs. Week 8 (Exit)|The total enrollment goal was 10. One participant dropped out during the baseline II visit, thus week 8 score was not obtained for that participant and the change from baseline to week 8 could not be collected. Thus, the analysis includes 9 participants instead of proposed 10.||HAMD scale units||Standard Deviation|Mean
653621|NCT01979029|Other Pre-specified|Systemic Blood Pressure||after ligating the inferior mesentric artery and measuring the blood pressure of the marginal artery of distal colon|||mmHg||Standard Deviation|Mean
653622|NCT01979029|Secondary|Distal Colon Length||after digestive tract reconstruction|||cm||Standard Deviation|Mean
653626|NCT01978743|Secondary|ART Regimen Preference|Evaluate patient preference in ART regimen (Atripla, EFV/FTC/TDF versus RAL + FTC/TDF) through self-administered questionnaires.|week 0 and week 8|Each participant was asked a single self-administered question on their ART preference and asked to chose one of the 3 answers; 1. prefer to take Atripla, 2. prefer RAL-based regimen (that they received in study) or 3. no preference.||participants|||Number
653627|NCT01978743|Secondary|Sleep Quality|Assess for changes in sleep pattern and quality prior to and after switching off EFV-based regimen through a self-administered Pittsburg Sleep Quality Index (PSQI). Measure consists of 19 items with each weighted on 0-3 scale and the sum produces a total score, which ranges from 0-21. The lower the score the healthier the sleep quality.|week 0 and week 8|||units on a scale||Standard Deviation|Mean
653628|NCT01978743|Secondary|Fasting Lipid Profile|Measure the change in fasting lipid panel prior to and after switching off EFV-based regimen.|week 0 and week 8|Change in lipid panel pre- and post-switch to RAL-based regimen||mg/dL||Standard Deviation|Mean
653629|NCT01978743|Secondary|Neurocognitive Changes Measured by a Panel of Indexes: WAIS-R, HAMD, DASS-21, FRSBE, STAI|"Assess for changes in cognitive and affective function prior to and after switching off EFV-based regimen. Indexes used to access neurocognitive changes included:
Wechsler Adult Intelligence Scale (WAIS-R) Digital Symbol Substitution Test: sensitive to brain dmamage, dementia, age and depressive changes. Range of 0-100, the higher the score the better the person's performance
Hamilton Rating Scale for Depression (HAMD): Measure of depression. Score of 0-7 is normal, score of >20 is moderate/severe depression
Depression Anxiety Stress Scale (DASS-21) the lower the score, the less severe depression, anxiety and stress. Scale range of 0-63
Frontal Systems Behavior Scale (FRSBE): Increased score indicates greater behavioral impairment associated with frontal systems, range 37.2 to 186
Spielberger state trait anxiety inventory (STAI): the higher the score the greater then anxiety level, range of 20 to 80."|week 0 and week 8|||units on a scale||Standard Deviation|Mean
653630|NCT01978743|Secondary|Other Neurometabolite Changes Measured by MRS|Use MRS to evaluate a fuller panel of known neurometabolites (in addition to the primary endpoints) to evaluate for prominent and significant changes associated with EFV use.|week 0 and week 8|The arbitrary units are expressed as the output from MRS software. While similar to concentration (mM) due to assumptions in the software, it is best expressed as arbitrary units for comparison from week 0 to week 8.||arbitrary units||Standard Deviation|Mean
653631|NCT01978743|Primary|Neural Activation Networks Using Functional Magnetic Resonance Imaging (fMRI)|Assess changes in neural activation correlated with affective disturbances associated with EFV vs. RAL using fMRI employing a paradigm that probes affective symptomatologies typical with EFV use; anxiety/dysphoria and affective dysregulation, and their association with changes in cognitive function. Four brain regions of interests (ROIs) are specified to show the differential frontal-limbic activation patterns in the task-evoked neural responses to the 3 linear contrasts of Pre-/Post-/ Pre-vs. Post-switch: [Negative Word vs. Neutral Word] x [No-Go Trial Block vs. Go Trial Block]: anterior Frontal Pole (aFP), posterior Cingulate Gyrus (pCG), dorsal anterior Cingulate Gyrus (daCG), Left Hippocampus (LHC). A linear mixed-effects model is utilized to examine the effect sizes of the key Regimen/Condition contrasts, with the Subject factor as the random-effect, and Age incorporated as a co-variate of no interest. A z-score is the Mean with a SD=1 and Measure of Dispersion equal to 1.|week 0 and week 8|8 of 10 enrolled patients passed QA testing to qualify for final fMRI data analyses. The 3 linear contrasts of Pre-switch/Post-switch/Pre- vs. Post-switch: [Neg vs.Neu] x [No-Go vs. Go] are reported as z-score (standardized effect size measures with SD=1). Z-score is obtained for each subject, group Z-score is obtained via a mixed-effects model.||z-score|||Number
653632|NCT01978743|Primary|Neurometabolites Based on Magnetic Resonance Spectroscopy (MRS)|Assess the levels of neuro-metabolites measured by MRS at week 0 before switching to the efavirenz-based therapy. Two areas of the brain: 1) posterior cingulate gyrus and 2) anterior cingulate will be assessed for the levels of brain creatine (Cr), gamma-aminobutyric acid (GABA) and glutathione (GLU).|week 0 and week 8|The arbitrary units are expressed as the output from MRS software. While similar to concentration (mM) due to assumptions in the software, it is best expressed as arbitrary units for comparison from week 0 to week 8.||arbitrary units||Standard Deviation|Mean
653633|NCT01978600|Secondary|Mean 24-hour IOP at Week 4|24-hour IOP (fluid pressure inside the eye) is the mean of all the time points assessed (8 AM to 6 AM). IOP was measured with a calibrated applanation tonometer in millimeters of mercury (mmHg). One eye from each subject was chosen as the study eye and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).|Week 4: 8AM, 10AM, 12PM, 2PM, 4PM, 6PM, 8PM, 10PM, 12AM, 2AM, 4AM, 6AM|This analysis population includes all participants who received study medication and had at least one on-therapy study visit.||mmHg||Standard Deviation|Mean
653634|NCT01978600|Secondary|Mean Diurnal IOP at Week 4|Diurnal IOP (fluid pressure inside the eye) is the mean of the diurnal time points assessed (8 AM to 8 PM). IOP was measured with a calibrated applanation tonometer in millimeters of mercury (mmHg). One eye from each subject was chosen as the study eye and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).|Week 4: 8AM, 10AM, 12PM, 2PM, 4PM, 6PM, 8PM|This analysis population includes all participants who received study medication and had at least one on-therapy study visit.||mmHg||Standard Deviation|Mean
653635|NCT01978600|Primary|Mean Nocturnal IOP at Week 4|Nocturnal IOP (fluid pressure inside the eye) is the mean of the nocturnal time points assessed (10 PM to 6 AM). IOP was measured with a calibrated applanation tonometer in millimeters of mercury (mmHg). One eye from each subject was chosen as the study eye and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).|Week 4: 10PM, 12AM, 2AM, 4AM, 6AM|This analysis population includes all participants who received study medication and had at least one on-therapy study visit.||mmHg||Standard Deviation|Mean
653658|NCT01977781|Secondary|Intraocular Pressure|Intraocular pressure is the measure of the fluid pressure within the eye as measured by tonometry. Intraocular pressure is normally measured in millimeters of mercury (mmHg). The normal range for intraocular pressure is 12-20 mmHg, there is no better or worse measurement.|10 weeks|Measurements are reported from the 10 week study visit. At this time 3 subjects were lost to follow-up and 4 subjects dropped out of the study due to burning sensations. 3 subjects dropped out from the Tacrolimus arm and 1 subject dropped out of the Methylprednisolone arm.||millimeters of mercury (mmHg)||Standard Deviation|Mean
653636|NCT01978145|Secondary|Change From Baseline in COPD Assessment Test (CAT) Scores at Week 12|The CAT is a participant-completed instrument designed to provide a simple and reliable measure of health status in COPD for the assessment and long-term follow-up of the individual participant. The CAT consists of eight items, each formatted on a semantic differential scale. Participants rated their experience on a 6-point scale for each question, ranging from 0 to 5 with a maximum total score of 40. Higher scores indicate greater disease impact. CAT of each participant was assessed at Baseline (Day 1) and Week 12 (Day 85) of each treatment period. Change from Baseline within each period was calculated as values at Week 12 minus period specific Baseline value. The change from Baseline in CAT overall score at Week 12 was analyzed using a mixed effects ANCOVA model, with participant-level Baseline CAT overall score, adjusted treatment period specific Baseline CAT overall score, treatment group, treatment period as fixed effects and participant as a random effect.|Baseline and Week 12 of each treatment period|ITT population. Only those participants available at the specified time points were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
653637|NCT01978145|Secondary|Change From Baseline in St George’s Respiratory Questionnaire-COPD (SGRQ C) Score at Week 12|The SGRQ-C is a 40-item COPD-specific questionnaire designed to measure the effect of COPD and its treatment on the participant’s health-related quality of life (HRQoL). The SGRQ-C includes 14 questions with a total of 40 items grouped into three components (symptoms, activity, and impacts). Each questionnaire response has a unique empirically derived weight. The lowest possible weight is zero and the highest is 100. Higher scores indicate greater impairment of HRQoL. HRQoL of participants was assessed using the SGRQ-C at Baseline (Day 1) and Week 12 of each treatment period. Change from Baseline was calculated as value at Week 12 minus the period specific Baseline value. Change from Baseline in SGRQ total score at Week 12 was analyzed using a mixed effects ANCOVA model, with participant-level Baseline SGRQ total score, adjusted treatment period-specific Baseline SGRQ total score, treatment group, and treatment period as fixed effects and participant as a random effect.|Baseline and Week 12 of each treatment period|ITT population. Only those participants available at the specified time points were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
653638|NCT01978145|Secondary|Change From Baseline in Transition Dyspnoea Index (TDI) Focal Score at Days 28, 56 and 85|Baseline Dysponea Index (BDI) and Transition Dyspnoea Index (TDI) are interview-based measurements of breathlessness due to COPD related daily living activities. Scores depend on ratings for 3 categories: functional impairment, magnitude of task and magnitude of effort. BDI was collected at Day 1 and TDI at Days 28, 56 and 85 of each treatment (trt) period. Each BDI scale has 5 possible scores ranging from 0 to 4, with 0 (worst) to 12 (best) as the total range. Each TDI scale has 7 possible scores ranging from -3 to +3, with -9 (worst) to +9 (best) as the total range. TDI focal score >=1 is considered to be a clinically meaningful change. Change from Baseline was calculated as TDI minus BDI values. Analysis was performed using MMRM by par. level BDI focal score, adjusted period-specific BDI focal score, trt group, trt period, visit, visit*trt group, visit*par. level BDI focal score, visit*adjusted period-specific BDI focal score as a fixed effect and with par. as a random effect.|Baseline, and Days 28, 56 and 85|ITT population. Only those participants available at the specified time points were analyzed (n=X, X in the category title).||Scores on a scale||Standard Error|Least Squares Mean
653639|NCT01978145|Secondary|FEV1 Area Under the Curve From 0 to 10 Hours (AUC [0-10]) on Day 85 of Each Treatment Period|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1. The FEV1 was measured on Day 85 of each treatment period at time 0 (predose),15 minutes, 30 minutes, 1, 2, 4, 6, and 10 hours post morning dosing for determination of AUC 0 to10 hours. The AUC was analyzed using a mixed effects analysis of covariance (ANCOVA) with participant-level Baseline (Day 1 trough FEV1), adjusted period-specific Baseline (Day 1 trough FEV1), treatment group and period as fixed effects and participant as a random effect.|Day 85 of each treatment period|ITT population. Only those participants available at the specified time points were analyzed.||Liter*hours||Standard Error|Least Squares Mean
653640|NCT01978145|Secondary|Change From Baseline in Trough Morning Forced Expiratory Volume in 1 Second (FEV1) at Day 28 and 56|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. The trough FEV1 at Days 28 and 56 is defined as morning prebronchodilator and predose (12 hours after the last evening dose Days 27 and 55). Trough FEV1 was measured electronically by spirometer in the morning, before using the bronchodilator and predose, at Days 28 and 56 of each Treatment Period. Baseline was defined as the value obtained predose (0 minutes) on day 1 in each treatment period. Change from Baseline within each period was calculated as trough FEV1 at Day 85 minus the period specific Baseline value. The change from Baseline in trough FEV1 was analyzed using mixed model for repeated measures analysis, having fixed effect participant level Baseline, adjusted period-specific Baseline, treatment group, period, visit, visit by treatment, visit by participant level Baseline, visit by adjusted period-specific Baseline, with participant as random effect.|Baseline and Days 28 and 56 of each treatment period|Intent-to-Treat (ITT) Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).||Liters (L)||Standard Error|Least Squares Mean
653641|NCT01978145|Primary|Change From Baseline in Trough Morning Forced Expiratory Volume in 1 Second (FEV1) at Day 85|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. The trough FEV1 is defined as morning prebronchodilator and predose (12 hours after the last evening dose Day 84). Trough FEV1 was measured electronically by spirometer in the morning, before using the bronchodilator and predose, at Week 12 (Day 85) of each Treatment Period. Baseline was defined as the value obtained predose (0 minutes) on day 1 in each treatment period. Change from Baseline within each period was calculated as trough FEV1 at Day 85 minus the period specific Baseline value. The change from Baseline in trough FEV1 was analyzed using mixed model for repeated measures analysis, having fixed effect participant level Baseline, adjusted period-specific Baseline, treatment group, period, visit, visit by treatment, visit by participant level Baseline, visit by adjusted period-specific Baseline, with participant as random effect.|Baseline and Day 85 of each treatment period|Intent-to-Treat (ITT) Population: all participants randomly assigned to treatment who received at least one dose of randomized study treatment in the treatment period. Only those participants available at the specified time points were analyzed.||Liters (L)||Standard Error|Least Squares Mean
653963|NCT01972776|Secondary|AUCtau, Steady State (AUCtau,ss) (Part 1)|Venous blood samples were collected for concentration-time profiles.|day 14 (from pre-dose to 72 hours post dose)|All Part 1 participants who received active treatment.||ng*h/mL||Standard Deviation|Mean
653642|NCT01978119|Secondary|Change From Baseline in the Percentage (%) of Rescue-free Days Over 12 Weeks (From Paper Diary Card) for Each Treatment Period(TP)|A rescue-free day is defined as a 24-hour period with no rescue medication usage recorded (i.e. both the day-time and night-time numbers of puffs of Salbutamol/Albuterol are zero). Percentage of Rescue-Free Days was calculated over each 12-week Treatment Period, dividing the number of rescue-free days by the length of the TP. The BL value of change from BL in % rescue free days is defined as an average of the last 7 available recorded values the Screening Period (for treatment period 1) and of the Washout Period (for treatment period 2). Change from BL was the difference over 12 weeks for each treatment period compared to BL. The change from BL in the % of rescue medication-free days averaged over the 12-week TP was analyzed, using mixed effects ANCOVA model, with par level BL % of rescue-free days, adjusted period-specific BL % of rescue-free days treatment group and period as fixed effects and par as a random effect.|Baseline and up to Day 85 of each Treatment Period|ITT population, Only those participants available at the specified time points were analyzed||Percentage of rescue-free days||Standard Error|Least Squares Mean
653643|NCT01978119|Secondary|Change From Baseline in Asthma Control Test (ACT) Over 12 Weeks for Each Treatment Period|The ACT is a 5-item questionnaire with a score of 1 to 5 for each item (1=poor control and 5=good control). The scores from each question were added to give an overall score. Baseline was defined as the value obtained predose (0 minutes) on day 1 of each Treatment Period. Change from Baseline was the difference in ACT score at the timepoint compared to Baseline score. The change from Baseline in overall ACT score was analysed, using mixed effects ANCOVA model, with participant level Baseline overall ACT score, adjusted period-specific Baseline overall ACT score, treatment group and period as fixed effects and participant as a random effect.|Baseline and up to Day 85 of each Treatment Period|ITT population, Only those participants available at the specified time points were analyzed||Scores on the scale||Standard Error|Least Squares Mean
653644|NCT01978119|Secondary|Change From Baseline in the Percentage of Symptom-Free Days From Paper Diary Card Over 12 Weeks|A Symptom-Free day was defined as a 24-hour period with no symptoms recorded. Percentage of Symptom-Free Days was calculated dividing number of Symptom-Free days by the length of the Treatment Period. The baseline value of change from baseline in % of symptom free days is defined as an average of the last 7 available recorded values the Screening Period (for treatment period 1) and of the Washout Period (for treatment period 2). Change from Baseline was the difference in percentage of Symptom-Free days at week 12 compared to Baseline. The change from Baseline in the percentage of Symptom-Free days averaged over the 12-week Treatment Period was analyzed, using mixed effects ANCOVA model, with participant level Baseline percentage of Symptom-Free days, adjusted period-specific Baseline percentage of Symptom-Free days, treatment group and period as fixed effects and participant as a random effect.|Baseline and up to Day 85 of each Treatment Period|ITT population, Only those participants available at the specified time points were analyzed||Percentage of symptom-free days||Standard Error|Least Squares Mean
653645|NCT01978119|Secondary|Change From Baseline in Day-time(AM) and Night-time (PM) Asthma Symptoms(Sy) From Paper Diary Card (PDC) Over 12 Weeks(wk) for Each Treatment Period(TP)|AM Sy scores were recorded nightly on PDC using the scale:0=No Sy during day,1=Sy for one short period during day,2=Sy for two or more short periods during day,3=Sy for most of day-not affecting normal daily activities,4=Sy for most of day-did affect normal daily activities,5=Sy so severe-could not go to work or perform normal daily activities. Similarly, PM Sy scores were recorded every morning using the scale:0=No Sy during night,1=Sy causing me to wake once(or early),2=Sy causing me to wake twice or more(or early),3=Sy causing me to be awake most of night,4=Sy severe-did not sleep. BL= average of last 4 available of the last 7 days of Screening Period(TP 1) and of Washout Period(TP 2). Change from BL in average of daily scores=difference over 12 wks for each TP compared to BL. AM and PM Sy Scores were separately averaged over each of the two 12-wk TP. Total value of each endpoint over 12-wk TP was divided by number of days with non-missing data to obtain an average for each subject|Baseline and up to Day 85 of each Treatment Period|ITT population, Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Participants at each time point may have been different therefore a total of 82 participants analyzed represents the overall ITT population.||Scores on the scale||Standard Deviation|Mean
653646|NCT01978119|Secondary|Change From Baseline (BL) in Rescue Medication Use Over 12 Weeks (From Paper Diary Card) for Each Treatment Period (TP)|Rescue medication usage for each 24-hour period is defined as the total numbers of puffs of Salbutamol/Albuterol within 24 hours (i.e. number taken during the day and number taken during the night). The total usage over the 12 week TP was divided by the number of days with nonmissing rescue medication data to get an average usage per participant. BL is the average of the last 4 available recorded values during the last 7 days of the Screening Period (for TP 1) and of the Washout Period (for TP 2). Change from BL in average usage of rescue medication was the difference over 12 weeks for each TP compared to BL. The change from BL in the percentage of rescue medication use averaged over the 12-week TP was analysed using mixed effects ANCOVA model, with par level BL rescue medication use, adjusted period-specific BL rescue medication use, treatment group and period as fixed effects and par as a random effect.|Baseline and up to Day 85 of each Treatment Period|ITT population, Only those participants available at the specified time points were analyzed||Puffs per day||Standard Error|Least Squares Mean
653647|NCT01978119|Secondary|Change From Baseline (BL) in Morning Peak Expiratory Flow Rate (PEFR) Over 12 Weeks (From Paper Diary Card) for Each Treatment Period(TP)|The PEFR is a paricipant’s(par) maximum speed of expiration, as measured with a peak flow meter(PFM). All par were issued a PFM and instructed to perform the activity in triplicate in the morning prior to taking the bronchodilator. The best among the 3 readings was selected. Efficacy measurement was recorded by the par in the paper Diary Card for morning PEFR. The total PEFR over the 12 week TP was divided by the number of days with non-missing PEFR data to obtain an average for each par. Change from BL in average morning PEFR is the difference over 12 weeks for each TP compared to BL. BL is the average of the last 4 available recorded values during the last 7 days of the Screening Period (for TP 1) and of the Washout Period (for TP 2). The change from BL in the PEFR averaged over the 12-week TP was analysed using a mixed effects ANCOVA model with participant level BL PEFR, adjusted period-specific BL PEFR, treatment group, and period as fixed effects, and par as a random effect.|Baseline and up to Day 85 of each Treatment Period|ITT population, Only those participants available at the specified time points were analyzed||Liters per minute||Standard Error|Least Squares Mean
653648|NCT01978119|Secondary|Change From Baseline in Morning Trough FEV1 at Day 28 and Day 56|Pulmonary function was measured by FEV1, a measure of lung function, and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 measurements were taken electronically by spirometry at predose (Baseline), on Days 28 and 56 of each Treatment Period. Baseline was defined as the value obtained predose (0 minutes) on Day 1of each Treatment Period. Change from Baseline within each period was calculated as trough FEV1 at Day 28 and 56 minus the period specific Baseline value.The change from Baseline in trough FEV1 at Day 28 and Day 56 was analysed via the primary analysis model. Least Squares mean values for the change from Baseline in trough FEV1 at Day 28 and Day 56 were obtained from the primary analysis model (for each treatment and for the treatment difference), and displayed alongside corresponding 95% confidence intervals.|Baseline, Day 28, and Day 56|ITT population, Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Participants at each time point may have been different therefore a total of 82 participants analyzed represents the overall ITT population.||Liter||Standard Error|Least Squares Mean
653649|NCT01978119|Secondary|FEV1 AUC (0-12) at Day 85 of Each Treatment Period|The AUC was analysed using a mixed effects analysis of covariance (ANCOVA) with participant-level baseline (day 1 trough FEV1), adjusted period-specific baseline (day 1 trough FEV1), treatment group and period as fixed effects and participant as a random effect.|Day 85 of each Treatment Period|ITT population, Only those participants available at the specified time points were analyzed.||Liter*hours||Standard Error|Least Squares Mean
653650|NCT01978119|Secondary|FEV1 Area Under the Curve From 0 to 12 Hours (AUC [0-12]) on Day 1 of Each Treatment Period|The AUC was analysed using a mixed effects analysis of covariance (ANCOVA) with participant-level baseline (day 1 trough FEV1), adjusted period-specific baseline (day 1 trough FEV1), treatment group and period as fixed effects and participant as a random effect.|Day 1 of each Treatment Period|ITT population, Only those participants available at the specified time points were analyzed.||Liter*hours||Standard Error|Least Squares Mean
653651|NCT01978119|Primary|Change From Baseline in Trough Morning Forced Expiratory Volume in 1 Second (FEV1) at Day 85|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. The trough FEV1 is defined as morning prebronchodilator and predose (12 hours after the last evening dose Day 84). Trough FEV1 was measured electronically by spirometer in the morning, before using the bronchodilator and predose, at Week 12 (Day 85) of each Treatment Period. Baseline was defined as the value obtained predose (0 minutes) on day 1 in each treatment period. Change from Baseline within each period was calculated as trough FEV1 at Day 85 minus the period specific Baseline value. The change from Baseline in trough FEV1 was analysed using Mixed Model for Repeated Measures analysis, having fixed effect Participant level Baseline, Adjusted period-specific Baseline, Treatment group, Period, Visit, Visit by treatment, Visit by Participant level Baseline, Visit by Adjusted period-specific Baseline, with participant as a random effect.|Baseline and Day 85|Intent-to-Treat (ITT) Population: all participants randomly assigned to treatment who received at least one dose of randomised study treatment in the Treatment Period. Only those participants available at the specified time points were analyzed.||Liter||Standard Error|Least Squares Mean
653652|NCT01977820|Primary|Number of Subjects With Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Death and AEs Leading to Discontinuation|An AE was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A SAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.|Screening up to 24 weeks + 4-week follow-up|The safety analysis population included all the randomized subjects who received at least one dose of study treatment.||Subjects|||Number
653653|NCT01977794|Secondary|Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, AEs Leading to Discontinuation and AEs Leading to Death|An AE was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment emergent AEs was AEs that started or worsened in severity on or after the date of first dose of IMP until the end of the study. AEs leading to death and discontinued were also presented.|Baseline up to Day 127 (end of trial)|Safety analysis set included all subjects who received at least 1 dose of IMP.||subjects|||Number
653654|NCT01977794|Secondary|Change From Baseline in Heart Rate (HR) After 18 Weeks of Treatment|Baseline was defined as the latest HR before study treatment administration|Baseline, Week 18|MITT analysis set was defined as all randomized and treated subjects with at least 1 SBP measurement after the date of first dose of IMP. Here “Number of subjects analyzed” signifies those subjects who were evaluable for this outcome measure.||beats per minute||Standard Deviation|Mean
653655|NCT01977794|Secondary|Percentage of Subjects With Controlled Blood Pressure||Baseline up to Week 18|MITT analysis set included all randomized and treated subjects with at least 1 SBP measurement after the date of first dose of IMP.||percentage of subjects|||Number
653656|NCT01977794|Secondary|Change From Baseline in Diastolic Blood Pressure (DBP) After 18 Weeks of Treatment|Baseline was defined as the latest DBP before study treatment administration.|Baseline, Week 18|MITT analysis set was defined as all randomized and treated subjects with at least 1 SBP measurement after the date of first dose of IMP. Here “Number of subjects analyzed” signifies those subjects who were evaluable for this outcome measure.||mmHg||Standard Deviation|Mean
653657|NCT01977794|Primary|Mean Reduction In Systolic Blood Pressure (SBP) After 18 Weeks of Treatment From Baseline|Baseline was defined as the latest SBP under monotherapy.|Baseline, Week 18|MITT analysis set was defined as all randomized and treated subjects with at least 1 SBP measurement after the date of first dose of IMP. Here “Number of subjects analyzed” signifies those subjects who were evaluable for this outcome measure.||millimeters of mercury (mmHg)||Standard Deviation|Mean
653670|NCT01977625|Primary|Percent Change in Blood Oxygen Level Dependent (BOLD) Signal|Blood-oxygen-level dependent contrast imaging, or BOLD-contrast imaging, is a method used in functional magnetic resonance imaging (fMRI) to observe different areas of the brain or other organs, which are found to be active at any given time. BOLD signals were compared from baseline, first intervention and second intervention.|10 weeks|All participants who completed all phases of the study were included in the outcome analysis.||percent change||Standard Deviation|Mean
653659|NCT01977781|Secondary|Visual Acuity|Visual acuity is measured by asking subjects to read letters on a chart that consists of different rows of letters. Each row of letters corresponds to different levels of visual acuity. The Logarithm of the Minimum Angle of Resolution (LogMAR) scale generally ranges from 0 to 1, with 0 corresponding to 20/20 vision and 1 corresponding to 20/200 vision. The range from 0-1 is not absolute, however, as patients who have vision better than 20/20 or vision worse than 20/200 will score out side of the 0 to 1 range.|10 weeks|Measurements are reported from the 10 week study visit. At this time 3 subjects were lost to follow-up and 4 subjects dropped out of the study due to burning sensations. 3 subjects dropped out from the Tacrolimus arm and 1 subject dropped out of the Methylprednisolone arm.||LogMAR Scale||Standard Deviation|Mean
653660|NCT01977781|Secondary|Tear Film Break-Up Time|Tear Film Break-Up Time measures the amount of time, in seconds, that the tear film completely coats the ocular surface after each blink. The longer the amount of time the tear film completely coats the ocular surface is considered to be better than a shorter amount of time.|10 weeks|Measurements are reported from the 10 week study visit. At this time 3 subjects were lost to follow-up and 4 subjects dropped out of the study due to burning sensations. 3 subjects dropped out from the Tacrolimus arm and 1 subject dropped out of the Methylprednisolone arm.||Seconds||Standard Deviation|Mean
653661|NCT01977781|Secondary|Schirmer Tear Test (mm)|Schirmer tear test measures the amount of tear secretion produced by a patient in millimeters (mm). Generally, the greater amounts of tear secretion is better than smaller amounts of tear secretion. The minimum value of this scale is 0 mm of tear secretion and there is no maximum value to this scale.|10 weeks|Measurements are reported from the 10 week study visit. At this time 3 subjects were lost to follow-up and 4 subjects dropped out of the study due to burning sensations. 3 subjects dropped out from the Tacrolimus arm and 1 subject dropped out of the Methylprednisolone arm.||millimeter (mm)||Standard Deviation|Mean
653662|NCT01977781|Secondary|Corneal Epitheliopathy (Corneal Fluorescein Staining Using the NEI Grading Scheme)|Corneal fluorescein staining is used to assess the level of corneal epitheliopathy that is related to dry eye disease. The corneal fluorescein staining scale ranges from 0 to 15, with 0 representing the minimum level of corneal epitheliopathy and 15 representing the maximum level of epitheliopathy.|10 weeks|Measurements are reported from the 10 week study visit. At this time 3 subjects were lost to follow-up and 4 subjects dropped out of the study due to burning sensations. 3 subjects dropped out from the Tacrolimus arm and 1 subject dropped out of the Methylprednisolone arm.||units on a scale||Standard Deviation|Mean
653663|NCT01977781|Secondary|Ocular Surface Disease Index (OSDI) Questionnaire|The OSDI questionnaire is a 12-question survey used to measure the symptoms of dry eye disease. Each of the 12 individual questions rate each of the dry eye symptoms on a 0-4 scale, with 4 meaning that the symptom is present all of the time and 0 meaning the symptom is present none of the time. The overall ODSI score is calculated by adding all of the values from the 12 questions, multiplying that value by 25, and dividing the resulting value by the number of questions answered. This results in an overall scale that ranges from 0-100, with 100 being severe dry eye symptoms and 0 being no dry eye symptoms.|10 weeks|Measurements are reported from the 10 week study visit. At this time 3 subjects were lost to follow-up and 4 subjects dropped out of the study due to burning sensations. 3 subjects dropped out from the Tacrolimus arm and 1 subject dropped out of the Methylprednisolone arm.||units on a scale||Standard Deviation|Mean
653664|NCT01977781|Primary|Ocular Burning Sensation, Ocular Discharge, Ocular Redness, Ocular Itching, Foreign Body Sensation|Ocular burning sensation, ocular discharge, ocular redness, ocular Itching, and foreign body sensation were measured to evaluate the safety and tolerability of topical tacrolimus 0.05% twice a day in the treatment of patients with ocular GVHD. Safety and tolerability of topical tacrolimus 0.05% twice a day will be monitored by the occurrence of systemic and ocular adverse events in addition to symptoms directly related to the instillation or use of the investigational medication. Subjects will be monitored at each study visit for the occurrence of any adverse events found through examination or patient reports. Tolerability will be evaluated at every visit with a self-response questionnaire that assessed burning sensation, discharge, redness, itchiness, and foreign body sensation on a scale from 0 to 4 (none = 0, trace = 1, mild = 2, moderate = 3, and severe = 4). Where a higher value represents more symptoms (less tolerability).|10 weeks|The results are taken from the week 10 study assessment||units on a scale||Standard Deviation|Mean
653665|NCT01977729|Other Pre-specified|Positive and Negative Affect Scale for Children|Positive and Negative Affect Scale for Children (PANAS-C). Negative affect (NA) will be assessed using the NA subscale on the PANAS-C. The 15 NA items (e.g., sad, miserable) on the 27-item PANAS-C are scored 1 (very slightly or not at all) to 5 (extremely). Higher scores in the NA subscale indicate higher levels of negative affect.|20 weeks from enrollment|No data collected.|||||
653666|NCT01977729|Secondary|Multidimensional Anxiety Scale for Children|Multidimensional Anxiety Scale for Children (MASC-2; Self-report and Parent completed). Treatment outcome will be assessed on a specific symptom level from the youth's and parent's perspective using the MASC-2. The MASC-2 consists of 50 items across 5 factors: Separation Anxiety/Phobias, Generalized Anxiety Disorder, Social Anxiety, Obsessions & Compulsions, and Harm Avoidance. MASC T-scores less than 65 indicate the child is no longer in the clinical range of anxiety symptoms.|20 weeks from enrollment|Study was terminated before randomization.|||||
653667|NCT01977729|Primary|Clinical Global Impression Severity & Improvement Scales|Youth outcome will be assessed on a global level using the Clinical Global Impression (CGI) Severity Scale, ranging from 1 (not at all) to 7 (among the most extremely ill patients). Higher ratings indicate greater anxiety symptom severity. The CGI Improvement Scale ranges from 1 (very much improved) to 7 (very much worse). Lower ratings indicate greater improvement on anxiety symptom severity. A CGI Improvement Scale rating of 1 or 2 indicates clinically meaningful improvements in anxiety symptom severity.|20 weeks from enrollment|Medication was never given, and tests were never done.|||||
653668|NCT01977690|Primary|Average Neck Pain Level|Patients self-recorded their average level of pain on a scale from 1 to 10 for each post-surgery day beginning on postoperative day 2. 1 Meaning least pain, 10 meaning worst level of pain|1 month|4 participants in the Clavicle brace group did not tolerate the brace and are included in the standard management group for this analysis. Only participants will available data are included in the analysis.||units on a scale (VAS pain scale)||Standard Deviation|Mean
653669|NCT01977625|Secondary|Change in BADDS Total Score|The total BADDS ranged from 0-120 with higher scores meaning greater problems with memory, attention and focus. Difference in BADDS score from Baseline to End of Treatment for each study Arm was calculated.|10 weeks|Participants who completed all 3 scans.||change in units||Standard Deviation|Mean
653671|NCT01977612|Secondary|Median Patient Satisfaction Score of Scar Appearance|Patients will be asked to rate the general appearance, location and comfort of the scar. This was collected as a continuous variable. Patients were given a paper survey and asked to please draw a single slash across a provided line indicating how satisfied they were with the appearance of their scar. The beginning of the line was designated “very unsatisfied” or 0% and the end of the line was “very satisfied” or 100%.|4-8 weeks post-operative|-Data was not collected on 13 patients in the Stainless Steel Staple arm and 12 patients in the 4-0 Monocryl Suture arm||Patient Satisfaction Score||Inter-Quartile Range|Median
653672|NCT01977612|Secondary|Cosmesis Score as Measured by the Stony Brook Scar Evaluation Score|"Ranges from 0 (worst) to 5 (best)
Sum of width, height, color, hatch, and overall appearance where a better outcome has a value of 5 and a worse outcome has a value of 0"|4-8 weeks post-operative|-Data was not collected from 10 patients in the Stainless Steel Staple arm and 9 patients in the 4-0 Monocryl Suture arm||units on a scale||Inter-Quartile Range|Median
653673|NCT01977612|Secondary|Analog Pain Score on Postoperative Days 3-4|The highest pain score as recorded by nursing staff at a minimum of every 8 hours between 72-96 hours postoperatively.|3-4 days post-surgery|Data was not collected from any patients for this outcome measure|||||
653674|NCT01977612|Secondary|Operative Time|Time from skin incision to the end of skin closure|During surgery|Data was not collected from 3 patients in the stainless steel staple arm and 1 patient in the 4-0 Monocryl suture arm||minutes||Inter-Quartile Range|Median
653675|NCT01977612|Secondary|Incidence of Wound Infection|Purulent drainage, cellulitis, abscess, or a wound that requires drainage, debridement or antibiotics associated with a clinical diagnosis of infection.|4-8 weeks post-surgery|||Participants|||Count of Participants
653676|NCT01977612|Secondary|Incidence of Wound Disruption||4-8 weeks post-surgery|-Data on incidence of wound disruption was not collected on 9 patients in the stainless steel staple arm and 9 patients in the 4-0 Monocryl suture arm.||Participants|||Count of Participants
653677|NCT01977612|Primary|Number of Participants With Wound Disruption or Infection (Wound Complications) Occurring Within 4-8 Weeks of the Date of the Primary Surgery.||4-8 weeks post-surgery|||Participants|||Count of Participants
653678|NCT01977573|Secondary|Number of Weeks Dose Withheld Because Hemoglobin (Hgb) Exceeded the Upper Limit|Number of Weeks dose was withheld because hemoglobin exceed the upper limit is presented as the number of participants with withheld dose during the time periods categorized by Weeks.|From Week 4 up to Week 24|ITT population.||participants|||Number
653679|NCT01977573|Secondary|Number of Participants Receiving Additional Therapies of Blood Transfusions, Intravenous (IV) Iron or rhEPO at Any Time Post-Baseline|Participants receiving additional therapies of blood transfusions, intravenous (IV) iron or rhEPO any time Post Baseline were analyzed. RhEPO was not applicable for the control arms since it was a planned therapy in those arms, hence presented as NA. (EudraCT only: A value of 99999 is used where no data is available or NA.)|From Day 1 up to Week 28|ITT Population||participants|||Number
653680|NCT01977573|Secondary|Number of Participants With at Least One Dose Cycle up to 24 Weeks|A dose cycle is a series of three directional dose changes (that is, increase, decrease, increase; or decrease, increase, decrease). participants|Up to 24 weeks|Completers population. Only participants in the GSK1278863 arms with dose cycles were analyzed.||participants|||Number
653681|NCT01977573|Secondary|Number of Participants With at Least One Hemoglobin (Hgb) Cycle up to 24 Weeks|A Hgb excursion is a series of decreasing or increasing Hgb values differing by >=1.5 grams per deciliter. A Hgb cycle is two consecutive Hgb excursions in different directions.|Up to 24 weeks|Completers population.||participants|||Number
653682|NCT01977573|Secondary|Number of Participants With at Least One Hemoglobin (Hgb) Excursion up to 24 Weeks.|A Hgb excursion is a series of decreasing or increasing Hgb values differing by >=1.5 grams per deciliter.|Up to 24 weeks|Completers population.||participants|||Number
653683|NCT01977573|Secondary|Number of Dose Cycles up to 24 Weeks|A dose cycle is a series of three directional dose changes (that is, increase, decrease, increase; or decrease, increase, decrease).|Up to 24 weeks|Completers population. Only participants in the GSK1278863 arms with dose cycles were analyzed.||number|||Number
653684|NCT01977573|Secondary|Number of Hemoglobin (Hgb) Cycles up to 24 Weeks|A Hgb cycle is calculated as two consecutive Hgb excursions in different directions. A Hgb excursion is a series of decreasing or increasing Hgb values differing by >=1.5 grams per deciliter.|Up to 24 Weeks|Completers population. Only participants with Hgb cycles were analyzed.||number of Hgb cycles|||Number
653685|NCT01977573|Secondary|Number of Hemoglobin (Hgb) Excursions|A Hgb excursion is a series of decreasing or increasing Hgb values differing by >=1.5 grams per deciliter. Hgb cycle is calculated as two consecutive Hgb excursions in different directions.|Up to 24 Weeks.|Completers Population: ITT participants who fully completed study without prematurely discontinuing study drug. Only participants with Hgb excursions were analyzed.||number of excursions|||Number
653686|NCT01977573|Secondary|Mean Final Dose of GSK1278863 up to 24 Weeks|The starting dose was kept constant for the first 4 Weeks after randomization. Later, the need to adjust the dose of GSK1288863 was evaluated at every scheduled visit according to a pre-specified algorithm, to achieve and maintain hemoglobin within the specified target range. Target range was defined as: Original Hgb Criteria of 9.0 to 10.5 g/dL, and Amended Hgb Criteria of 10.0 to 11.5 g/dL. Sites in the USA used 9.0 to 10.5 g/dL.|Up to 24 Weeks|ITT population.||milligrams per day||Standard Deviation|Mean
653687|NCT01977573|Secondary|Mean Total Cumulative Dose of GSK1278863 up to 24 Weeks|The starting dose was kept constant for the first 4 Weeks after randomization. Later, the need to adjust the dose of GSK1288863 was evaluated at every scheduled visit according to a pre-specified algorithm, to achieve and maintain hemoglobin within the specified target range. Target range was defined as: Original Hgb Criteria of 9.0 to 10.5 g/dL, and Amended Hgb Criteria of 10.0 to 11.5 g/dL. Sites in the USA used 9.0 to 10.5 g/dL.|Up to 24 Weeks|ITT population.||milligrams||Standard Deviation|Mean
653688|NCT01977573|Secondary|Timing of Dose Adjustments at Weeks 4, 8, 12, 16, and 20|After 4 Weeks, the need to adjust the dose of GSK1278863 was evaluated at every scheduled visit, to maintain hemoglobin within the target range. Target range was defined as: Original Hgb Criteria of 9.0 to 10.5 g/dL, and Amended Hgb Criteria of 10.0 to 11.5 g/dL. Sites in the USA used 9.0 to 10.5 g/dL. Dose adjustments were assigned automatically via the interactive voice/web response system. The number of participants with an adjustment are presented at the timings at which adjustments were done.|From Week 4 up to Week 20|ITT population. Only those participants with at least one dose adjustment of GSK1278863 were analyzed.||Participants|||Number
653689|NCT01977573|Secondary|Number of Participants With Dose Adjustments up to 24 Weeks, as a Measure of Dose Adjustment Frequency|After 4 Weeks, the need to adjust the dose of GSK1278863 was evaluated at every scheduled visit, to maintain hemoglobin within the target range. Target range was defined as: Original Hgb Criteria of 9.0 to 10.5 g/dL, and Amended Hgb Criteria of 10.0 to 11.5 g/dL. Sites in the USA used 9.0 to 10.5 g/dL. Dose adjustments were assigned automatically via the interactive voice/web response system. Frequency is presented as the number of participants with dose adjustment(s) once, twice, thrice, four times, or five times.|From week 4 up to 24 weeks|Intent-to-Treat population. Only those participants with at least one dose adjustment of GSK1278863 were analyzed.||participants|||Number
653690|NCT01977573|Secondary|Mean Number of Dose Adjustments up to 24 Weeks|After 4 Weeks, the need to adjust the dose of GSK1278863 was evaluated at every scheduled visit, to maintain hemoglobin within the target range. Target range was defined as: Original Hgb Criteria of 9.0 to 10.5 g/dL, and Amended Hgb Criteria of 10.0 to 11.5 g/dL. Sites in the USA used 9.0 to 10.5 g/dL. Dose adjustments were assigned automatically via the interactive voice/web response system.|From Week 4 up to 24 Weeks|Intent-to-Treat population. Only those participants with at least one dose adjustment of GSK1278863 were analyzed.||number of adjustments||Standard Deviation|Mean
653691|NCT01977573|Secondary|Concentration of GSK1278863 and Relevant Metabolites as a Population Pharmacokinetic Endpoint|Blood samples were collected for individual plasma GSK1278863 and metabolite (GSK2391220, GSK2487818, GSK2506102, GSK2531398, GSK2531401, and GSK2531403) concentration measurement on Day 1 (pre-dose), Wk 4 (6-12 hour, 7-13 hour, 8-14 hour, 9-15 hour post-dose), and Wk 20 (pre-dose, 1 hour, 2 hour, 3 hour post-dose). Participants available in each arm at the specified time points have been presented.|Day 1 (pre-dose), Week (Wk) 4 (6-12 hour, 7-13 hour, 8-14 hour, 9-15 hour post-dose), and Wk 20 (pre-dose, 1 hour, 2 hour, 3 hour post-dose)|Pharmacokinetics (PK) population: All participants from whom a PK sample was obtained and analyzed. This population did not include participants from the control groups.||nanograms per milliliter||Standard Deviation|Mean
653692|NCT01977573|Secondary|Change From Baseline in Reticulocyte Cell Count at Week 24|Reticulocyte count is a blood test that measures the percentage of reticulocytes in the blood. Reticulocytes are slightly immature red blood cells. Baseline is the last pre-dose red reticulocyte count. Change from Baseline in reticulocyte cell count was calculated by subtracting the Baseline count from the Week 24 count.|Baseline and Week 24|ITT population. Only participants with data available at specific timepoint were analyzed.||percentage of reticulocytes||Standard Deviation|Mean
653693|NCT01977573|Secondary|Change From Baseline in Red Blood Cell Count at Week 24|Baseline is the last pre-dose red blood cell count. Change from Baseline in red blood cell count was calculated by subtracting the Baseline count from the post-dose count.|Baseline and Week 24|ITT population. Only participants with data available at specific time point were analyzed.||10^12 cells per liter||Standard Deviation|Mean
653694|NCT01977573|Secondary|Change From Baseline in Hematocrit at Week 24|Baseline is the last pre-dose hematocrit value. Change from Baseline was calculated by subtracting the Baseline value from the Week 24 value.|Baseline and Week 24|ITT population. Only participants with data available at specific timepoint were analyzed.||percentage change in Fraction of 1||Standard Deviation|Mean
653695|NCT01977573|Secondary|Change From Baseline in Reticulocyte Hemoglobin (CHr) at Week 24|Reticulocytes are slightly immature red blood cells. Reticulocyte Hgb content is used to differentiate iron deficiency from other causes of anemia. Baseline is the last pre-dose CHr value. Change from Baseline in reticulocyte Hgb was calculated by subtracting the Baseline value from the post-dose value.|Baseline and Week 24|ITT population. Only participants with data available at specific time point were analyzed.||picogram||Standard Deviation|Mean
653696|NCT01977573|Secondary|Change From Baseline in Total Iron Binding Capacity (TIBC) at Week 24|TIBC measures the blood's capacity to bind iron with transferrin. Baseline is the last pre-dose TIBC value. Change from Baseline in TIBC was calculated by subtracting the Baseline value from the Week 24 value.|Baseline and Week 24|ITT population. Only participants with data available at specific timepoint were analyzed.||micromoles per liter||Standard Deviation|Mean
653697|NCT01977573|Secondary|Change From Baseline in Total Iron at Week 24|Baseline is the last pre-dose total iron value. Change from Baseline was calculated by subtracting the Baseline value from the Week 24 value.|Baseline and Week 24|ITT population. Only participants with available total iron values at Baseline and Week 24 were analyzed.||micromoles per liter||Standard Deviation|Mean
653698|NCT01977573|Secondary|Percent Change From Baseline in Transferrin Saturation at Week 24|Transferrin saturation is measured as a percentage; it is a ratio of serum iron and total iron-binding capacity. Baseline is the last pre-dose transferrin saturation value. Percent change was calculated as 100 multiplied by (exponential of mean change on log scale minus 1). Change was calculated by subtracting the Baseline value from the post-dose value.|Baseline and Week 24|ITT population. Only participants with data available at specific time point were analyzed.||percent change||95% Confidence Interval|Geometric Mean
653699|NCT01977573|Secondary|Change From Baseline in Transferrin Concentration at Week 24|Baseline is the last pre-dose transferrin value. Change from Baseline in transferrin was calculated by subtracting the Baseline value from the Week 24 value.|Baseline and Week 24|ITT population. Only participants with data available at specific time point were analyzed.||grams per liter||Standard Deviation|Mean
653700|NCT01977573|Secondary|Change From Baseline in Ferritin Concentration at Week 24|Baseline is the last pre-dose ferritin value. Change was calculated by subtracting the Baseline value from the Week 24 value.|Baseline and Week 24|ITT population. Only participants with data available at specific time point were analyzed.||micrograms per liter||Standard Deviation|Mean
653701|NCT01977573|Secondary|Percentage of Time Within, Below, and Above Hemoglobin (Hgb) Target Range, Between Weeks 12 and 24|The number of days a participant's Hgb was within target range was calculated by estimating (using linear interpolation) the number of days within target range between two scheduled Hgb visits. Percentage of time within range for a participant was calculated by dividing the total number of days that Hgb was within range during Weeks 12 to 24 by the total number of days the participant remained on treatment during Weeks 12 to 24. Similary, percent of time above and below Hgb target range was calculated. Target range was defined as: Original Hgb Criteria of 9.0 to 10.5 g/dL, and Amended Hgb Criteria of 10.0 to 11.5 g/dL. Sites in the USA used 9.0 to 10.5 g/dL.|Weeks 12 to 24|ITT population. Only participants with data available at specific time points were analyzed.||percentage of days||Standard Deviation|Mean
653783|NCT01976442|Primary|Survial Rate at 30 Days|The percentage of patients who were alive at 30 days after transfusion.|30 days|||percentage of participants|||Number
653702|NCT01977573|Secondary|Maximum Observed Percent Change From Baseline in Vascular Endothelial Growth Factor (VEGF)|Blood samples for control arm were collected pre-dose for VEGF measurement. Blood samples for GSK1278863 arms were collected on Day 1 (pre-dose ), Week 4 (6-12 hours post-dose ), Week 4 (7-13, 8-14, 9-15, hours post-dose ), Week 8 (pre -dose ), Week 12 (pre -dose ), Week 16 (pre -dose ), Week 20 (pre -dose , 3 hour post-dose ) Week 24 (pre -dose ), and Week 28 (pre -dose ) for VEGF measurement. The maximum observed change from baseline in VEGF was recorded for each arm . Baseline value for VEGF is the pre-dose value on Day 1. Change from Baseline in VEGF was calculated as the individual post-baseline values minus the Baseline value.|Baseline and up to Week 24|ITT population. Only participants with data available at Baseline and a maximum observed change were analyzed.||percent change in VEGF concentration||95% Confidence Interval|Geometric Mean
653703|NCT01977573|Secondary|Maximum Observed Change From Baseline in Serum Erythropoietin (EPO)|Blood samples for control arm were collected pre-dose for EPO measurement. Blood samples for GSK1278863 arms were collected on Day 1 (pre-dose ), Week 4 (6-12 hours post-dose ), Week 4 (7-13, 8-14, 9-15, hours post-dose ), Week 8 (pre -dose ), Week 12 (pre -dose ), Week 16 (pre -dose ), Week 20 (pre -dose , 3 hour post-dose ) Week 24 (pre -dose ), and Week 28 (pre -dose ) for EPO measurement. The maximum observed change from baseline in EPO was recorded for each arm. Baseline value for EPO is the pre-dose value on Day 1. Change from Baseline in EPO was calculated as the individual post-baseline values minus the Baseline value.|Baseline to Week 24|ITT population. Only participants having a Baseline EPO measurement and at least one post-baseline EPO measurement were analyzed.||International Units per liter||Standard Deviation|Mean
653704|NCT01977573|Secondary|Percent Change From Baseline in Hepcidin Concentration at Week 24|Baseline is the last pre-dose hepcidin value. Percent change was calculated as 100 multiplied by (exponential of mean change on log scale minus 1). Change was calculated by subtracting the Baseline value from the Week 24 value.|Baseline and Week 24|Intent-to-Treat (ITT) population consisted all randomized participants who received at least one dose of study drug, had a Baseline and at least one corresponding on-treatment assessment. Only participants with available hepcidin values at Baseline and Week 24 were analyzed.||percent change in Hepcidin||95% Confidence Interval|Geometric Mean
653705|NCT01977573|Secondary|Number of Participants Reaching Pre-defined Hgb Stopping Criteria|The Hgb stopping criteria was a value of <7.5 mg/dL obtained on-site via a validated point-of-care Hgb measurement device, which necessitated permanent discontinuation of the study medication. None of the participants met the stopping criteria therefore there is no data to present for this outcome measure.|Over a period of 24 Weeks|ITT population.||Participants|||Number
653706|NCT01977573|Secondary|Number of Participants With Hemoglobin (Hgb) in the Target Range at Week 24|Target range is defined as: Original Hgb Criteria of 9.0 to 10.5 gram/deciliter (g/dL), and Amended Hgb Criteria of 10.0 to 11.5 g/dL. Sites in the USA used 9.0 to 10.5 g/dL.|Week 24|ITT population. Only participants who were available at the indicated time point were analyzed.||participants|||Number
653707|NCT01977573|Primary|Summary of Hemoglobin (Hgb) Concentration at Week 24|"The original Hgb Criteria for Group 1- rhEPO naive participants with a stable baseline Hgb of 8.0-10.0 g/dL (8.0-10.0 g/dL USA site only) and for Group 2- rhEPO users with a stable baseline Hgb of 9.0-10.5 g/dL (9.0-10.5 g/dL USA site only); the Hgb target range was 9.0 to 10.5 g/dL (9.0-10.5 g/dL USA site only). The study amended Hgb Criteria for Group 1- rhEPO naive participants with a stable baseline Hgb of 8.0-11.0 g/dL and Group 2- rhEPO users with a stable baseline Hgb of 9.0-11.5 g/dL; Hgb target range - 10.0 to 11.5 g/dL. Data are presented for those participants following the original criteria (Original) and those following the amended (Amended) criteria. The primary objective was to characterize the ability of GSK1278863 to achieve mean Hgb response within the target range."|Week 24|Intent-to-Treat (ITT): The ITT population consisted of all randomized participants who received at least one dose of study drug, had a Baseline and at least one corresponding on-treatment assessment. Only participants who were available at the indicated time point were analyzed.||grams per deciliter||Standard Deviation|Mean
653708|NCT01977482|Secondary|Change From Baseline in Reticulocyte Count at Week 24|A reticulocyte count is a blood test that measures the percentage of reticulocytes in the blood. Reticulocytes are slightly immature red blood cells. Baseline value for reticulocyte count is the pre-dose value on Day 1. Change from Baseline in reticulocyte count was calculated as the Week 24 value minus the Baseline value.|Baseline (Day 1) and Week 24|ITT Population. Only participants with data available at specific time point were analyzed.||Percentage of reticulocytes in blood||Standard Deviation|Mean
653709|NCT01977482|Secondary|Change From Baseline in Red Blood Cells at Week 24|Baseline value for red blood cells is the pre-dose value on Day 1. Change from Baseline in red blood cells was calculated as the Week 24 value minus the Baseline value.|Baseline (Day 1) and Week 24|ITT Population. Only participants with data available at specific time point were analyzed.||10^12 cells/Liter||Standard Deviation|Mean
653710|NCT01977482|Secondary|Change From Baseline in Hematocrit at Week 24|Hematocrit is the ratio of the volume of red blood cells to the total volume of blood. Baseline value for hematocrit is the pre-dose value on Day 1. Change from Baseline in hematocrit was calculated as the Week 24 value minus the Baseline value.|Baseline (Day 1) and Week 24|ITT Population. Only participants with data available at specific time point were analyzed.||Ratio||Standard Deviation|Mean
653711|NCT01977482|Secondary|Change From Baseline in Reticulocyte Hemoglobin at Week 24|Baseline value for reticulocyte hemoglobin is the pre-dose value on Day 1. Change from Baseline in reticulocyte hemoglobin was calculated as the Week 24 value minus the Baseline value.|Baseline (Day 1) and Week 24|ITT Population. Only participants with data available at specific time point were analyzed.||Picogram||Standard Deviation|Mean
653712|NCT01977482|Secondary|Change From Baseline in Total Iron Binding Capacity at Week 24|Total iron-binding capacity is a medical laboratory test that measures the blood's capacity to bind iron with transferrin. Baseline value for total iron binding capacity is the pre-dose value on Day 1. Change from Baseline in total iron binding capacity was calculated as the Week 24 value minus the Baseline value.|Baseline (Day 1) and Week 24|ITT Population. Only participants with data available at specific time point were analyzed.||Micromoles/Liter||Standard Deviation|Mean
653713|NCT01977482|Secondary|Change From Baseline in Total Iron at Week 24|Baseline value for total iron is the pre-dose value on Day 1. Change from Baseline in total iron was calculated as the Week 24 value minus the Baseline value.|Baseline (Day 1) and Week 24|ITT Population. Only participants with data available at specific time point were analyzed.||Micromoles/Liter||Standard Deviation|Mean
653714|NCT01977482|Secondary|Percent Change From Baseline in Transferrin Saturation at Week 24|Transferrin saturation is measured as a percentage, it is the ratio of serum iron and total iron-binding capacity, multiplied by 100. Baseline value for transferrin saturation is the pre-dose value on Day 1. Percent change from Baseline =: 100*(exp(Mean change log scale)-1).|Baseline (Day 1) and Week 24|ITT Population. Only participants with data available at specific time point were analyzed.||Percent change||95% Confidence Interval|Geometric Mean
653715|NCT01977482|Secondary|Change From Baseline in Transferrin at Week 24|Baseline value for transferrin is the pre-dose value on Day 1. Change from Baseline in transferrin was calculated as the Week 24 value minus the Baseline value.|Baseline (Day 1) and Week 24|ITT Population. Only participants with data available at specific time point were analyzed.||grams (g)/Liter (L)||Standard Deviation|Mean
653716|NCT01977482|Secondary|Change From Baseline in Ferritin at Week 24|Baseline value for ferritin is the pre-dose value on Day 1. Change from Baseline in ferritin was calculated as the Week 24 value minus the Baseline value.|Baseline (Day 1) and Week 24|ITT Population. Only participants with data available at specific time point were analyzed.||Micrograms/Liter||Standard Deviation|Mean
653717|NCT01977482|Secondary|Percent Change From Baseline in Hepcidin at Week 24|Hepcidin is a regulator of iron metabolism. Baseline value for transferrin saturation is the pre-dose value on Day 1. Percent change from Baseline was calculated as 100 multiplied by exponential of mean change in log scale minus 1.|Baseline (Day 1) and Week 24|ITT Population. Only participants with data available at specific time point were analyzed.||Percent change||95% Confidence Interval|Geometric Mean
653718|NCT01977482|Secondary|Population Plasma PK Parameters of GSK1278863 and Metabolites|Blood samples were collected for individual plasma GSK1278863and metabolite (GSK2391220, GSK2499166, GSK2531403, GSK2531400, GSK2531399, and GSK2531398) concentrations measurement on Day (D) 1 (pre-dose [PrD), at Week (W) 4 (6-12, 7-13, 8-14, and 9-15 hour [hr] post-dose [PoD), and at W20 (PrD, 1, 2, and 3 hour PoD). Pharmacokinetic population: All participants from whom a PK sample has been obtained and analyzed.|Day 1, Week 4, and Week 20|Pharmacokinetic Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points; thus, the overall number of participants analyzed reflects everyone in the pharmacokinetic population||nanograms (ng)/milliliter (mL)||Standard Deviation|Mean
653719|NCT01977482|Secondary|Maximum Observed Percent Change From Baseline in Vascular Endothelial Growth Factor (VEGF)|Blood samples for control arm were collected on Day 1 (pre-dose), Week 4 (5-15 minutes post-dose), Week 8 (pre-dose), Week 12 (pre-dose), Week 16 (pre-dose), Week 20 (pre-dose, 5-15 minutes post-dose), Week 24 (pre-dose), and Week 28 (pre-dose) for VEGF measurement. Blood samples for GSK1278863 arms were collected on Day 1 (pre-dose), Week 4 (6-12 hours post-dose), Week 4 (7-13, 8-14, 9-15, hours post-dose), Week 8 (pre-dose), Week 12 (pre-dose), Week 16 (pre-dose), Week 20 (pre-dose, 3 hour post-dose) Week 24 (pre-dose), and Week 28 (pre-dose) for VEGF measurement. The maximum observed percent change from Baseline in VEGF was recorded for each arm. Baseline value for VEGF is the pre-dose value on Day 1. Percent change from Baseline was calculated as 100 multiplied by exponential of mean change in log scale minus 1.|Baseline (Day 1) to Week 28|ITT Population. Only participants with data available at specific time point were analyzed.||Percent change||95% Confidence Interval|Geometric Mean
653720|NCT01977482|Secondary|Maximum Observed Change From Baseline in Erythropoietin (EPO)|Blood samples for control arm were collected on Day 1 (pre-dose), Week 4 (5-15 minutes post-dose), Week 8 (pre-dose), Week 12 (pre-dose), Week 16 (pre-dose), Week 20 (pre-dose, 5-15 minutes post-dose), Week 24 (pre-dose), and Week 28 (pre-dose) for EPO measurement. Blood samples for GSK1278863 arms were collected on Day 1 (pre-dose), Week 4 (6-12 hours post-dose), Week 4 (7-13, 8-14, 9-15, hours post-dose), Week 8 (pre-dose), Week 12 (pre-dose), Week 16 (pre-dose), Week 20 (pre-dose, 3 hour post-dose) Week 24 (pre-dose), and Week 28 (pre-dose) for EPO measurement. The maximum observed change from baseline in EPO was recorded for each arm. Baseline value for EPO is the pre-dose value on Day 1. Change from Baseline in EPO was calculated as the individual post-dose values minus the Baseline value.|Baseline (Day 1) to Week 28|ITT Population. Only participants with data available at specific time point were analyzed.||international units(IU)/Liter (L)||Standard Deviation|Mean
653721|NCT01977482|Secondary|Number of Participants Reaching Pre-defined Hgb Stopping Criteria|The number of participants who reached the Hgb stopping criteria of Hgb concentration <7.5 g/dL were presented.|Up to 24 weeks|ITT Population||Participants|||Number
653722|NCT01977482|Secondary|Number of Participants With Hgb in the Target Range at Week 24|The number of participants with Hgb in the target range of 10.0 to 11.5 g/dL at Week 24 was recorded for each arm.|Week 24|ITT Population. Only participants with data available at specific time point were analyzed.||Participants|||Number
653723|NCT01977482|Secondary|Percentage of Time Within, Below, and Above Hgb Target Range Between Weeks 20 and 24|The percentage of time in Hgb target range between Weeks 20 and 24 for a participant was calculated by dividing the total number of days that Hgb was within the target range (10.0 to 11.5 g/dL) while on treatment during Weeks 20 to 24 (using linear interpolation) by the total number of days the participant remained on treatment during the defined period. Similarly, percentage of time above Hgb target range and percentage of time below Hgb target range were calculated.|Week 20 to Week 24|ITT population. Only participants with data available at specific timepoint were analyzed.||Percentage of days||Standard Deviation|Mean
653724|NCT01977482|Secondary|Hgb Concentration at Week 24|Hgb values measured at Week 24 are presented.|Week 24|ITT Population. Only participants with data available at specific time point were analyzed.||g/dL||Standard Deviation|Mean
653725|NCT01977482|Primary|Change From Baseline in Hemoglobin (Hgb) at Week 4|Baseline Hgb value was the average of three Hgb values taken during screening period at Week (W) -4, W-2 and Day 1. Change from Baseline in Hgb was calculated as W4 value minus the Baseline value. To model the dose-response relationship a four-parameter Emax model was used. The dose response dataset was based on all non-missing data collected up to W4. Participants (par.) who had a Week 2 Hgb measurement, but a missing Week 4 Hgb measurement were included with a change from Baseline at Week 4 value imputed as twice the change from Baseline at Week 2. E0 is the expected Hgb change from Baseline for a par. receiving placebo and experiencing the average Hgb Baseline observed in the study. Emax is the expected Hgb change from Baseline for a par. receiving the highest dose above which no further increase in response can be achieved. ED50 is the dose that attains the intermediate response. Gamma is the slope parameter. Alpha is the coefficient of the model covariate for centred Baseline.|Baseline (Week -4, Week-2 and Day 1) and Week 4|ITT Population. Only participants with data available at specific time point were analyzed.||grams (g)/deciliter (dL)||Standard Deviation|Mean
653726|NCT01977456|Other Pre-specified|The Number of Participants With Good Outcomes According to the Modified Rankin Score.|Modified Rankin score (mRS) dichotomized to good outcome (mRS 0-1 or return to baseline), poor outcome (all others including death). Results reported are good outcome.|90 days from the date of stroke onset|||participants|||Number
653727|NCT01977456|Secondary|The Number of Patients Who Develop Parenchymal Hemorrhage Types 1( PH-1) and 2 (PH-2).|Any parenchymal hemorrhage types PH-1 or PH-2 as visualized on CT|within 36 hours after stroke onset|||participants|||Number
653728|NCT01977456|Secondary|The Number of Patients Who Experience Any Intracerebral Hemorrhage (ICH).|Any ICH symptomatic (as defined above) or asymptomatic (that visualized on CT or MRI only)|within 36 hours after stroke onset|||participants|||Number
653729|NCT01977456|Primary|The Number of Patients Who Experience Symptomatic Intracerebral Hemorrhage (sICH).|Any ICH related to a decline in neurologic status or the development of new neurologic symptoms which in the judgment of the clinical investigator was related to the ICH. Judgment of significant neurological decline was made by the local clinical investigator|within 36 hours after stroke onset|||participants|||Number
653730|NCT01976988|Secondary|Number of Participants With VTE Within 30-day After Surgery|any VTE occuring within 30-days after surgery - clinical or asymptomatic - detected by venous duplex ultrasound, vq scan or ct pulmonary angiogram.|30 day postop period|||participants|||Number
653731|NCT01976988|Secondary|Hospital Stay|Length of postoperative hospital stay|30 day postop period|||days||Inter-Quartile Range|Median
653732|NCT01976988|Secondary|Number of Participants With Surgical Complications|Major or minor medical and surgical complications|30 day postop period|||participants|||Number
653733|NCT01976988|Secondary|Number of Participants With Postoperative Thrombocytopenia|Thrombocytopenia defined as >50% or greater drop in platelet count|30 day postop period|||participants|||Number
653734|NCT01976988|Secondary|Number of Participants With Bleeding Complications|"Major bleeding defined as any intracranial or intraocular hemorrhage or bleeding from any site associated with >2g/dL drop in hemoglobin or transfusion of >2 unit packed RBCs (including operative site bleeding, unexpected upper or lower gastrointestinal hemorrhage, or retroperitoneal hemorrhage) or any hemorrhage needing surgical intervention/reoperation or leading to death.
Minor bleeding defined as wound hematoma, ecchymosis >10 cm, epistaxis of more than 2 minute duration, macroscopic hematuria, unexpected upper or lower GI hemorrhage associated with <2g/dL drop in hemoglobin or <2 unit packed RBC transfusion"|30 day postop period|||participants|||Number
653735|NCT01976988|Primary|Number of Participants With Postoperative VTE Within 48 Hours After Surgery|Number of participants with postoperative VTE (deep venous thrombosis (DVT) or pulmonary embolism (PE) as demonstrated by duplex sonography or high probability on ventilation-perfusion scan or CT chest angiography within 48 hour postop period|48 hour postop period|||participants|||Number
653736|NCT01976871|Secondary|The Clinician Global Impression of Change Scale|The Clinician Global Impression of Change scale (CGIC) will be used to assess patient satisfaction with treatment.|Study Visit 1 (Day 1) and Study Visit 3 (approximately 35 days after initiating the switch from the oral dopamine agonist to the transdermal rotigotine)|||participants|||Number
653737|NCT01976871|Secondary|The Patient Global Impression of Change Scale|"The Patient Global Impression of Change scale (PGIC) will be used to assess patient satisfaction with treatment.
The PGIC assesses subjective changes in symptoms during clinical trials. This single-item scale asks participants to rate their symptoms as “very much improved,” “much improved,” “minimally improved,” “no change,” “minimally worse,” “much worse,” or “very much worse.” The measure provides a responsive and easily interpretable assessment of participants’ evaluations of the importance of their improvement or worsening."|Study Visit 1 (Day 1) and Study Visit 3 (approximately 35 days after initiating the switch from the oral dopamine agonist to the transdermal rotigotine)|||participants|||Number
653738|NCT01976871|Secondary|Preference of Medication Scale (POM)|"The POM will be used to assess patient satisfaction with treatment.
The POM scale is designed to summarize subjects’ preference for the study medication compared to prior therapy. It asks a single question: How does this current medicine compare to the previous RLS medicine(s) you were taking? The response set is as follows: (1) Much Better, I prefer this medication (indicating preference for rotigotine); (2) Slightly Better; (3) About the Same; (4) Slightly Worse; (5) Much Worse, I much prefer my previous medication (indicating preference for oral dopamine agonist)."|Study Visit 1 (Day 1) and Study Visit 3 (approximately 35 days after initiating the switch from the oral dopamine agonist to the transdermal rotigotine)|||participants|||Number
653739|NCT01976871|Secondary|RLS-6 Scale|"The RLS-6 scale will be used to determine the overall efficacy of RLS symptom control on rotigotine, calculated as a mean score for each scale during the final treatment week vs baseline.
The RLS-6 scale are 11-point (0=not present to 10=very severe) metrics for measuring RLS severity. Four questions delineate a severity profile of RLS during different night and daytime periods: at bedtime, during the night, during the day at rest, during daily activities. The final two questions assess satisfaction with sleep and severity of sleepiness during the day. The RLS-6 scales have been validated on a day-to-day basis, with relatively low placebo effect compared to other RLS rating scales.
Minimum score 0, maximum score 60. A decrease in the RLS-6 score indicates a better outcome. The RLS-6 scale was completed each day of the study and averaged for the baseline week (approximately days 1-7 of the study) and the final week (approximately days 21-28 of the maintenance period)."|Average of Baseline titration week (approximately days 1-7 of the study) vs. Average of Final Treatment week (integrating data from days 28-35 after initiating the switch from the oral dopamine agonist to the transdermal rotigotine)|||units on a scale||Standard Deviation|Mean
653740|NCT01976871|Secondary|International Restless Legs Scale (IRLS)|"The IRLS will be used to determine the overall efficacy of RLS symptom control on rotigotine.
The IRLS is a well-validated instrument for measuring RLS severity during the past week. It includes 10 questions encompassing intensity and frequency of symptoms, associated sleep problems, and the impact of symptoms on the patients’ mood and daily functioning. This scale has been shown to have high internal consistency, inter-examiner reliability, test-retest reliability, and convergent validity.
Minimum score 0, maximum score 40. A decrease in the IRLS score indicates a better outcome."|Study Visit 1 (Day 1) and Study Visit 3 (approximately 35 days after initiating the switch from the oral dopamine agonist to the transdermal rotigotine)|||units on a scale||Standard Deviation|Mean
655306|NCT01952665|Primary|Dryness|Participant rating for lens dryness. Collected at 4 weeks wear for both study lens pairs. (0-10, 0= Very Dry, 10= No Dryness).|4 weeks|||units on a scale||Standard Deviation|Mean
653741|NCT01976871|Primary|Proportion of Patients Completing the Switch and Their Adverse Events|"The primary endpoint will be the safety and tolerability of switching from an oral dopamine agonist to rotigotine.
The CGIC scales were developed to assess treatment outcomes in pharmacological studies. The scales are meant completed by the clinician in person after assessment of the subject. They include 4 global scales describing the severity of illness, change in severity from baseline, therapeutic efficacy, and tolerability of treatment.
Clinical Global Impression - Improvement scale (CGI-I) rated as: 1, very much improved since the baseline week; 2, much improved; 3, minimally improved; 4, no change from baseline; 5, minimally worse; 6, much worse; or 7, very much worse since the baseline week. The CGI-I was performed at baseline and at Week 5 to see which participants rated as much or very much improved.
Adverse Events are reported in the Adverse Events module."|Participants will be monitored for the duration of the study, approximately 6-10 weeks depending upon scheduling of visits|||participants|||Number
653742|NCT01976845|Secondary|Produces Amnesia(Memory Recall)|"Ability to recall (memory of):
•recall of 2 pictures"|one day|Subjects who recall the picture||participants|||Number
653743|NCT01976845|Secondary|Scores on the Verbal Rating Scale For Sleepiness (Sedation)|Using the verbal rating scale (VRS) for anxiety (0= none to 10 = extremely sleepiness)|one day|||Scores on a Scale (0-10)||Standard Deviation|Mean
653744|NCT01976845|Primary|Scores on the Verbal Rating Scale For Anxiety|Using the verbal rating scale (VRS) for anxiety (0= none to 10 = extremely nervous)|one day|||Scores on a Scale (0-10)||Standard Deviation|Mean
653745|NCT01976819|Primary|Device Preference Rating.|"Patients were asked to rate the devices on a scale from 0-10, where 10 indicates the best score and 0 the worst score. The overall mean satisfaction with the speaking valve was rated."|Weeks 1 and 2 (Old device, data averaged) and Week 3 (Updated device)|||units on a scale||Standard Deviation|Mean
653746|NCT01976819|Primary|Hours of HME Use Per Day.|The mean number of hours of TW use per 24 hours was calculated.|Weeks 1 and 2 (Old device, data averaged) and Week 3 (Updated device)|||hours per day||Standard Deviation|Mean
653747|NCT01976819|Primary|Evaluate Patient Experiences Associated With Exposure to the Speaking Valve With a Heat- and Moisture Exchanger (TW) for Tracheotomized Patients Based on Results From Questionnaires.|"Patients were asked to use either the old TW15 and the TW22 HME device for a week, data combined for the two devices (the device used was recorded). After each week, patients completed a device specific questionnaire (Borg Scale).
After the re-design (ie Updated speaking valve), patients were asked to use the new Speaking Valve for a week and then to complete relevant sections of the same questionnaire. Both at baseline and in the follow-up, patients were asked about their breathing using a Borg scale at a particular moment. This scale has a range from 0-6 where a score close to 0 indicates less breathing problems."|3 weeks including Baseline, week 1, 2 (old device) and week 3 (updated device).|||units on a scale||Standard Deviation|Mean
653748|NCT01976806|Other Pre-specified|Urine Beta-human Chorionic Gonadotropin|Urine beta-human chorionic gonadotropin was measured in all female subjects for eligibility (pregnant females excluded for safety).|Baseline||||||
653749|NCT01976806|Other Pre-specified|Serum Complete Blood Count|Baseline and 3 month follow-up complete blood counts were measured for descriptive purposes of our study population and for safety.|Baseline and 3 months||||||
653750|NCT01976806|Other Pre-specified|Serum Fasting Lipid Profile|Baseline and follow-up fasting lipid profiles were measured for descriptive purposes of our study population.|Baseline and 3 months||||||
653751|NCT01976806|Other Pre-specified|Vital Signs|Baseline and follow-up vital signs, including temperature, blood pressure, heart rate were measured to assess for safety and eligibility (uncontrolled hypertensives were excluded).|Baseline and 3 months||||||
653752|NCT01976806|Other Pre-specified|Change in Red Blood Cell Membrane Docosahexaenoic Acid|Red blood cell phospholipid fatty acids were measured at baseline and 3-month follow up as a measure of adherence.|Baseline and 3 months||||||
653753|NCT01976806|Secondary|Urine N-Terminal Telopeptides|Urine N-Terminal Telopeptides are a measure of systemic bone turnover.|Baseline and 3 months||||||
653754|NCT01976806|Secondary|Serum Soluble Vascular Cell Adhesion Molecule|Serum soluble vascular cell adhesion molecule (VCAM) is a measure of systemic inflammation.|Baseline and 3 months||||||
653755|NCT01976806|Secondary|Serum High-sensitivity Interleukin-6|Serum high-sensitivity interleukin-6 is a measure of systemic inflammation.|Baseline and 3 months||||||
653756|NCT01976806|Secondary|Serum High-sensitivity C-reactive Protein|Serum high-sensitivity C-reactive protein is a measure of systemic inflammation.|Baseline and 3 months||||||
653757|NCT01976806|Secondary|Gingival Crevicular Fluid Interleukin-1 Beta|Gingival crevicular fluid (GCF) samples were analyzed for Interleukin-1 beta, which is a measure of local gingival inflammation.|Baseline and 3 months||||||
653758|NCT01976806|Secondary|Gingival Crevicular Fluid Interleukin-6|Gingival crevicular fluid (GCF) samples were analyzed for Interleukin-6, which is a measure of local gingival inflammation.|Baseline and 3 months||||||
653759|NCT01976806|Secondary|Gingival Crevicular Fluid High Sensitivity C-reactive Protein|Gingival crevicular fluid (GCF) is the fluid bathing the teeth under the gum line. GCF samples were analyzed for high sensitivity C-reactive protein as a measure of local gingival inflammation.|Baseline and 3 months||||||
653760|NCT01976806|Secondary|Change in Bleeding on Probing (Yes/no)|Bleeding On Probing (BOP) is a measure of gingival inflammation and tissue destruction, which describes whether or not bleeding at the dental pocket occurred following probing.|Baseline and 3 months||||||
653761|NCT01976806|Secondary|Change in Plaque Index (0-3)|"Plaque Index (PI) is a measure of gingival inflammation as induced by bacterial plaque deposition at and under the gum line.
Score Criteria:
0: No plaque
A film of plaque adhering to the free gingival margin and adjacent area of the tooth, which can not be seen with the naked eye. But only by using disclosing solution or by using probe.
Moderate accumulation of deposits within the gingival pocket, on the gingival margin and/ or adjacent tooth surface, which can be seen with the naked eye.
Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin."|Baseline and 3 months||||||
653762|NCT01976806|Secondary|Change in Gingival Index (0-3)|"Gingival Index (GI) is a measure of gingival inflammation, which is assigned a score (0-3).
Score Criteria:
0: No inflammation.
Mild inflammation, slight change in color, slight edema, no bleeding on probing.
Moderate inflammation, moderate glazing, redness, bleeding on probing.
Severe inflammation, marked redness and hypertrophy, ulceration, tendency to spontaneous bleeding."|Baseline and 3 months||||||
653763|NCT01976806|Primary|Change in Pocket Depth (mm)|Pocket probing depth (PD) is the depth a dental probe can be inserted into a gingival pocket at a particular site (6 sites per tooth) measured in millimeters among teeth with PD greater than or equal to 5 mm (N=533 dental sites total).|Baseline and 3 months|||mm||Standard Error|Mean
653764|NCT01976663|Secondary|Mean Improvement in Overall Nasolabial Folds FACE-Q Score|Subjects evaluate nasolabial folds on the 5-item Nasolabial Folds module of the FACE-Q questionnaire. Responses to the 5 items are combined to create a scale score that ranged from 0 to 100, where 0 indicates that the subject is extremely bothered and 100 indicates that the subject is not all bothered by the appearance of the nasolabial fold. Improvement is defined as the score at Month 12 minus the baseline score.|Baseline, Month 12|modified intent-to-treat (mITT): all randomized and treated subjects with data at this time point||Scores on a Scale||Standard Deviation|Mean
653765|NCT01976663|Secondary|Percentage of Nasolabial Folds With ≥1-Point Improvement|Nasolabial fold severity is evaluated by the Evaluating Investigator on the 5-point Nasolabial Fold Severity Scale (ranging from 0=None [no wrinkle] to 4=Extreme [very deep wrinkle, redundant fold]). The percentage of nasolabial folds with ≥1-point improvement from baseline (i.e., decrease in severity) are reported.|Baseline, Month 12|modified intent-to-treat (mITT): all randomized and treated subjects||Percentage of Nasolabial Folds||95% Confidence Interval|Number
653766|NCT01976663|Primary|Percentage of Nasolabial Folds With ≥1-Point Improvement|Nasolabial fold severity is evaluated by the Evaluating Investigator on the 5-point Nasolabial Fold Severity Scale (ranging from 0=None [no wrinkle] to 4=Extreme [very deep wrinkle, redundant fold]). The percentage of nasolabial folds with ≥1-point improvement from baseline (i.e., decrease in severity) are reported.|Baseline, Month 6|modified intent-to-treat (mITT): all randomized and treated subjects||Percentage of Nasolabial Folds||95% Confidence Interval|Number
653767|NCT01976663|Primary|Mean Improvement (Reduction) in Nasolabial Fold Severity Using the 5-Point Nasolabial Fold Severity Scale (NLFSS)|Nasolabial fold severity is assessed by the Evaluating Investigator on the 5-point Nasolabial Fold Severity Scale (ranging from 0=None [no wrinkle] to 4=Extreme [very deep wrinkle, redundant fold]). Mean reduction from baseline in NFLSS is defined as score at baseline minus score at Month 6. The mean reduction indicated improvement (decrease) in nasolabial fold severity.|Baseline, Month 6|modified intent-to-treat (mITT): all randomized and treated subjects||Scores on a Scale||Standard Deviation|Mean
653768|NCT01976650|Secondary|Percentage of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved and was considered 'effective'. The percentage of patients with at least a 15 or more letter improvement in BCVA in the study eye are presented.|4 Years|Efficacy Population: all patients who were treated per protocol who had data available for analysis||Percentage of Participants|||Number
653769|NCT01976650|Primary|Number of Patients With Adverse Events or Adverse Drug Reactions|An Adverse Event is considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. An Adverse Drug Reaction is a harmful and unintended reaction that is incurred during routine administration or use of the drug, whose causal relationship with the drug cannot be excluded.|4 Years|Safety Population: all patients who were treated per protocol and completed a survey||Patients|||Number
653770|NCT01976624|Secondary|Change From Baseline in Intraocular Pressure (IOP)|IOP is a measurement of the fluid pressure inside the eye. A negative change from Baseline indicated an improvement. The median total treatment duration for participants was 63.0 days.|Baseline, Week 4|Efficacy population included all participants who were treated for on-label indications with data available for analysis.||mmHg||Standard Deviation|Mean
653771|NCT01976624|Primary|Number of Participants With Adverse Events and Adverse Drug Reactions|An Adverse Event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. An Adverse Drug Reaction was a harmful and unintended reaction that is incurred during routine administration or use of the drug, whose causal relationship with the drug cannot be excluded.|Up to 51 months|Safety population included all participants treated for on-label indications.||participants|||Number
653772|NCT01976572|Secondary|T1/2|Apparent plasma terminal elimination half-life|0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, and 48 hours post-dose|||hr||Standard Deviation|Mean
653773|NCT01976572|Secondary|Tmax|Time of maximum observed plasma concentration|0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, and 48 hours post-dose|||hr||Full Range|Median
653774|NCT01976572|Primary|Cmax of Candesartan|Maximum observed plasma concentration|0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, and 48 hours post-dose|PK Population: All subjects who receive at least one dose of candesartan and have sufficient interpretable PK data.||ng/mL||Standard Deviation|Mean
653775|NCT01976572|Primary|AUC0-t of Candesartan|Area under the plasma concentration-time curve from time zero up to the last quantifiable time-point|0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, and 48 hours post-dose|PK Population: All subjects who receive at least one dose of candesartan and have sufficient interpretable PK data.||ng*hr/mL||Standard Deviation|Mean
653776|NCT01976507|Secondary|Number of Participants With Minor Bleeding Events||Within 4 months following procedure (+/- 4 days)|||Participants|||Count of Participants
653777|NCT01976507|Secondary|Dabigatran Serum Drug Levels in Patients Experiencing a Major Bleeding or Thrombo-embolic Event.||Within 4 months following procedure (+/- 4 days)|This measure was removed from the protocol. No blood draws were done on any participants.|||||
653778|NCT01976507|Primary|Frequency of Major Thrombo-embolic Events in Patients Administered Dabigatran Following RF Ablation.||Within 4 months following procedure (+/- 4 days)|||number of events|||Number
653779|NCT01976507|Primary|Frequency of Major Bleeding Complications in Patients Administered Dabigatran Following RF Ablation.||Within 4 months following procedure (+/- 4 days)|||number of events|||Number
653780|NCT01976442|Primary|Survial Rate at 5 Years|The percentage of patients who were alive at 5 years after transfusion.|5 years|||percentage of participants|||Number
653781|NCT01976442|Primary|Survial Rate at 100 Days|The percentage of patients who were alive at 100 days after transfusion.|100 days|||percentage of participants|||Number
653782|NCT01976442|Primary|Survial Rate at 60 Days|The percentage of patients who were alive at 60 days after transfusion.|60 days|||percentage of participants|||Number
653784|NCT01976338|Secondary|Change From Baseline in NEI-VFQ-25 Composite and Subscale Scores at Month 3, Month 6 and Month 12|The VFQ-25 consists of 25 vision related questions across 11 vision related subscales, including general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision and peripheral vision, and a general health rating. Items are converted to a 0-100 scale on each subscale and for the composite score where higher scores represents better functioning.|Baseline, months 3, 6 and 12|The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. n=the number of patients with a value for both baseline and the specific post-baseline visit.||Scores on a Scale||Standard Deviation|Mean
653785|NCT01976338|Secondary|Change in Total Area of Fluorescein Leakage (Outer Subfield) From Baseline Over Time|Fluorescein leakage area was assessed using Fluorescein angiography (FA) in conjunction with 7-field color fundus photography (CF) at Screening, Month 3, Month 6 and End of Study visit for both eyes|Months 3, 6 and 12|The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. Mean value interpolation and last observation carried forward (MV-LOCF)||mm^2||Standard Deviation|Mean
653786|NCT01976338|Secondary|Change in Total Area of Fluorescein Leakage (Inner Subfield) From Baseline Over Time|Fluorescein leakage area was assessed using Fluorescein angiography (FA) in conjunction with 7-field color fundus photography (CF) at Screening, Month 3, Month 6 and End of Study visit for both eyes|Months 3, 6 and 12|The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. Mean value interpolation and last observation carried forward (MV-LOCF)||mm^2||Standard Deviation|Mean
653787|NCT01976338|Secondary|Change in Total Area of Fluorescein Leakage (Center Subfield) From Baseline Over Time|Fluorescein leakage area was assessed using Fluorescein angiography (FA) in conjunction with 7-field color fundus photography (CF) at Screening, Month 3, Month 6 and End of Study visit for both eyes|month 3, 6 and 12|The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. Mean value interpolation and last observation carried forward (MV-LOCF)||mm^2||Standard Deviation|Mean
653788|NCT01976338|Secondary|Change in Central-Sub-Field- Thickness (CSFT) Over Time|OCT (optical coherence tomography) was used to assess CSFT (Central Sub-Field Thickness) representing the average retinal thickness of the circular area within 1 mm diameter around the foveal center|Month 1 to month 12|The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. Mean value interpolation and last observation carried forward (MV-LOCF)||µm||Standard Deviation|Mean
653789|NCT01976338|Secondary|Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of 15 Letters in the Study Eye|Visual acuity (VA) was assessed at every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes for each post-baseline month whether or not a patient lost less than 15 letters of VA as compared with baseline.|Baseline to 12 months|The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. Mean value interpolation and last observation carried forward (MV-LOCF)||Participants|||Number
653790|NCT01976338|Secondary|Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time|Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters|Baseline to month 12|The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. Mean value interpolation and last observation carried forward (MV-LOCF)||Participants|||Number
653791|NCT01976338|Secondary|Best Corrected Visual Acuity (BCVA) Change Over Time|Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters. Mean Visual Acuity was averaged over all monthly assessments from month 1 to month 12 and compared to Baseline|Month 1 through Month 12|The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. Mean value interpolation and last observation carried forward (MV-LOCF)||Letters||Standard Deviation|Mean
653792|NCT01976338|Secondary|Average Change of Best Corrected Visual Acuity (BCVA) in Patients From Baseline to Month 1 Through Month 12|Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters. Mean Visual Acuity was averaged over all monthly assessments from month 1 to month 12 and compared to Baseline|Baseline to Month 1 through Month 12|The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. Mean value interpolation and last observation carried forward (MV-LOCF)||Letters||Standard Deviation|Mean
653793|NCT01976338|Primary|Average Change in Best Corrected Visual Acuity (BCVA) From Baseline to Month 1 Through Month 6|Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters. Mean Visual Acuity was averaged over all monthly assessments from month 1 to month 6 and compared to Baseline.|Baseline to Month 1 through Month 6|The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. Mean value interpolation and last observation carried forward (MV-LOCF)||Letters||Standard Deviation|Mean
653794|NCT01976312|Secondary|The Change in Patient Reported Outcomes in NEI-VFQ-25 Score (Composite Score and Subscales) at Month 3, 6 and 12 Compared to Baseline|The VFQ-25 consists of 25 vision related questions across 11 vision related subscales, including general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision and peripheral vision, and a general health rating. Items are converted to a 0-100 scale on each subscale and for the composite score where higher scores represents better functioning.|Month 3,6 and 12|The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. n= is the number of patients with a value for both baseline and the specific post-baseline visit.||Scores on a scale||Standard Deviation|Mean
653795|NCT01976312|Secondary|Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of <15 Letters in the Study Eye Over Time|Visual acuity (VA) was assessed at every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes for each post-baseline month whether or not a patient lost less than 15 letters of VA as compared with baseline.|Month 1 to 12 months|The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward||Participants|||Number
653796|NCT01976312|Secondary|Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time|Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters.|Month 1 to month 12|The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward||Participants|||Number
653797|NCT01976312|Secondary|Change From Baseline in Central-Sub-Field- Thickness (CSFT) Over Time|OCT (optical coherence tomography) was used to assess CSFT (Central Sub-Field Thickness) representing the average retinal thickness of the circular area within 1 mm diameter around the foveal center.|Month 1 to month 12|The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward||microns||Standard Deviation|Mean
653798|NCT01976312|Secondary|Best Corrected Visual Acuity (BCVA) Change From Baseline Over Time|Visual acuity (VA) was assessed on both eyes during every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes the change in visual acuity at each visit compared to baseline|Month 1 to 12 months|The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward||Letters||Standard Deviation|Mean
653799|NCT01976312|Secondary|Average Change of Best Corrected Visual Acuity (BCVA) From Baseline to Month 1 Through Month 12|Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters. Mean Visual Acuity was averaged over all monthly assessments from month 1 to month 12 and compared to Baseline|Baseline, 12 months|The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward||Letters||Standard Deviation|Mean
653800|NCT01976312|Primary|Average Change in Visual Acuity (Letters) From Baseline to Month 1 Through Month 3|"Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters.
Mean Visual Acuity was averaged over all monthly assessments from month 1 to month 3 and compared to Baseline."|Baseline, 3 Months|The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward||Letters||Standard Deviation|Mean
653801|NCT01976299|Secondary|Secondary Endpoint 3- Change in Kidney Function.|Change in kidney function by analyzing eGFR 3 to 5 days post procedure.|3-5 days|||mL/min/1.73m²||Standard Deviation|Mean
653802|NCT01976299|Secondary|Secondary Endpoint 2- Comparison of Serious Adverse Events.|Comparing event rates of serious adverse events 30 days following the index procedure.|30 Days|||events|||Number
653803|NCT01976299|Secondary|Secondary Endpoint 1-|Comparison in contrast media volume required between active treament and standard of care.|30 Days|Reduction in volume of contrast was analysed in an interim analysis once half the patient population was enrolled. Additionally, only subjects that completed the procedure were analyzed for this endpoint.||Contrast Volume (ml)||Standard Deviation|Mean
653804|NCT01976299|Primary|Primary Safety Endpoint- Number of Participants Experiencing a Device Related Serious Adverse Event|Analyze the incidence of device related serious adverse events within the treatment arm.|30 days|||Participants|||Count of Participants
653805|NCT01976299|Primary|Primary Effectiveness Endpoint|Reduction in the incidence of Contrast Induced Nephropathy (CIN) by evaluating Serum Creatinine levels in subjects for up to 5 days.|3-5 days|Only subjects that completed blood draws were analyzed for this outcome.||Participants|||Count of Participants
653806|NCT01976273|Primary|Visual Analog Scale (VAS) of Improvement Rated by a Blinded Dermatologist From at Week 10|The primary outcome was a blinded rating of improvement of the treatment area (1064nm Q-switch Laser Versus Glycolic Acid Peels) using a Visual Analog Scale (VAS). A dermatologist blindly evaluated the treated areas of each side from live subjects at baseline on the final follow up visit (week 10). The VAS of improvement was rated on a scale of 0 to10, with 0 being no improvement and 10 being the most improvement seen by the treatment.|Week 10|||units on a scale||Standard Deviation|Mean
653807|NCT01975974|Primary|Successful First Attempt Peripheral Venous Cannulation|we will compare the first attempt success rate using proposed ultrasound technique in total of 100 obese (BMI>30) surgical patients with existing published data. Mata-analysis of first attempt success rate using ultrasound for intravenous cannulation is 61.8% We predict 90% (50% improvement) success rate using the proposed ultrasound technique. Based on this prediction, a sample size of 100 patients provided more than 90% power to compare there two groups at the 0.05 significance level with a two-sided Chi square test.|one day|||participants|||Number
653808|NCT01975948|Other Pre-specified|Between Group Change in Sheehan Disability Scale (SDS)|The SDS is a visual analog scale which asks respondents to rate from 0-10 the extent to which symptoms have disputed: a: work/school work; b) social life/leisure activities; c) family life/home responsibilities. Total scores can range from 0-30, with lower scores indicating less disruption. We ompared between-group mean differences of SDS scores during follow-up, assessed as a group-by-time interaction. We used a multi-level mixed model analysis: physicians clustered within practices, patients clustered within their corresponding physicians, and longitudinal SDS ratings clustered within patients. The four follow-up time points were represented by indicator variables. The effect of the intervention was measured as an intervention by time interaction, and the time-by-group interaction was assessed using a likelihood ratio test.|Baseline, 1, 2, 3, and 6 months|All participants with at least one follow-up data (n=116) were included in the analysis||units on a scale||Standard Deviation|Mean
653809|NCT01975948|Other Pre-specified|Number of Patients That Were Prescribed Antidepressant (AD) at 6 Months|We compared between group use of antidepressant in both groups using the Client Service Receipt Inventory questionnaire at 6 months.|6 months|All participants with at least one follow-up data (n=116) were included in the analysis||Participants|||Count of Participants
653810|NCT01975948|Other Pre-specified|Between Groups Changes in Quality of Life From Baseline to 6 Months.|The Medical Outcomes Short Form (SF-36) assesses quality of life. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning possible. Aggregate scores are compiled as a percentage of the total points possible, using the RAND scoring table.We ompared between-group mean differences of SF-36 scores during follow-up, assessed as a group-by-time interaction. We used a multi-level mixed model analysis: physicians clustered within practices, patients clustered within their corresponding physicians, and longitudinal SF-36 ratings clustered within patients. The four follow-up time points were represented by indicator variables. The effect of the intervention was measured as an intervention by time interaction, and the time-by-group interaction was assessed using a likelihood ratio test.|Baseline, 1, 2, 3 and 6 months|All participants with at least one follow-up data (n=116) were included in the analysis||units on a scale||Standard Deviation|Mean
653811|NCT01975948|Other Pre-specified|Between Goup Change in Client Satisfaction Inventory (CSI) From Baseline to 6 Months|The CSI is a 25-item scale to measure the degree or magnitude of client satisfaction with care received. Responses range from 1 to 7. Total raw scores range from 0 to 175, with higher scores representing higher levels of satisfaction. Total scores were averaged reducing the overall score to a 7-point scale. We compared between-group mean differences of CSI scores during follow-up, assessed as a group-by-time interaction. We used a multi-level mixed model analysis: physicians clustered within practices, patients clustered within their corresponding physicians, and longitudinal CSI ratings clustered within patients. The four follow-up time points were represented by indicator variables. The effect of the intervention was measured as an intervention by time interaction, and the time-by-group interaction was assessed using a likelihood ratio test.|Baseline, 1, 2,3, and 6 months|All participants with at least one follow-up data (n=116) were included in the analysis||units on a scale||Standard Deviation|Mean
653812|NCT01975948|Other Pre-specified|Between Group Change in Physician Confidence and Comfort With Program Specific Tools and Skills|A modified version of a British Columbia (BC) developed survey, Practice Support Program Pre–Post Learning Module Questionnaire was used. Physicians were also asked to rate their level of familiarity, confidence and comfort with a variety of non-program specific mental health tools and skills for assisting patients with mental health concerns (e.g., CBIS manual, electronic hyperlinked mental health algorithm, Bounce Back program DVD, referrals for Bounce Back telephone coaching, ASW and coaching skills, Diagnostic Assessment Interview, Problem List Action Plan, CBIS resource list, CBIS skills handout, Family Physician Guide, and medication algorithm). Physician confidence was measured on a three point scale ranging from ‘very confident’ to ‘not at all confident. Mean scores were averaged and can range from one to three, with lower mean scores indicating higher levels of comfort, confidence and familiarity. Cronbach’s alpha was .98 at pre-test and .98 at post-test|Baseline and 6 months|||units on a scale||Standard Deviation|Mean
653813|NCT01975948|Other Pre-specified|Between Group Change in Physician Confidence and Comfort With Non-program Specific Tools and Skills|"A modified version of a British Columbia (BC) developed survey Practice Support Program Pre–Post Learning Module Questionnaire was used. Physicians were also asked to rate their level of familiarity, confidence and comfort with a variety of non-program specific mental health tools and skills for assisting patients with mental health concerns (e.g., PHQ9 & PHQ2, AUDIT, SMME, MOCA, GAF, GAD-7). Physician confidence was measured on a three point scale ranging from ‘very confident’ to ‘not at all confident. Mean scores were averaged and can range from one to three, with lower mean scores indicating higher levels of comfort, confidence and familiarity. Cronbach’s alpha for physicia was .90 at pre-test and .91 at post-test,
3"|Baseline and 6 months|||units on a scale||Standard Deviation|Mean
653814|NCT01975948|Other Pre-specified|Between Group Change at 6 Months From Baseline in Physician Confidence and Comfort in Managing Mental Illness|"A modified version of a British Columbia (BC) developed survey, Practice Support Program Pre–Post Learning Module Questionnaire was used. Physician confidence was measured on a three point scale ranging from ‘very confident’ to ‘not at all confident.’ Mean scores were averaged and can range from one to three, with lower scores indicating higher confidence. Physicians were asked to their level of confidence to:
diagnose depression
screen for addictions
screen for other mental health conditions
treat depression
treat other mental health disorders
prescribe medications for mental health conditions
assess patients’ problems and strengths
overall confidence in quality of mental health care provided
knowledge/awareness of non-pharmaceutical interventions
knowledge/awareness of regional mental health resources for patients
Cronbach’s alpha .84 at pre-test and .87 at post-test"|Baseline and 6 months|||units on a scale||Standard Deviation|Mean
655307|NCT01952665|Primary|Comfort|Participant rating for lens comfort. Collected at 4 weeks wear for both study lens pairs. (0-10, 0= Very Uncomfortable, 10= Cannot Feel).|4 weeks|||units on a scale||Standard Deviation|Mean
653815|NCT01975948|Secondary|Economic Impact|Health care costs in the two groups will be estimated using data gathered from the self report Client Service Receipt Inventory questionnaire, additional information will be obtained from Health Data Nova Scotia (HDND) registry. Administrative data will be collected from six of the HDNS registries: (1) Medical Services Insurance (MSI) Physician Billings, (2) Canadian Institute for Health Information (CIHI) Hospital Discharge Abstract Database, (3) Pharmacare Prescriptions, (4) Insured Patient Registry, (5) Patient Geography, (6) Licensed Provider Registry|January 1st, 2013 - September 31st, 2015 or end of available data||12/2017||||
653816|NCT01975948|Secondary|Between Group Changes in Occupational Functioning From Baseline to 6 Months|Lam’s Employment Absence and Productivity Scale (LEAPS) is a 7 item scale that assesses workplace impact of major depression. Each item is rated on a 5-point Likert scale with the following response format: none of the time (0%), some of the time (25%), half the time (50%), most of the time (75%), or all the time (100%), scored as 0-4, respectively. Total scores can range from 0-28 with lower scores indicating less disruption.We compared between-group mean differences of LEAPs scores during follow-up, assessed as a group-by-time interaction. We used a multi-level mixed model analysis: physicians clustered within practices, patients clustered within their corresponding physicians, and longitudinal LEAPs ratings clustered within patients. The four follow-up time points were represented by indicator variables. The effect of the intervention was measured as an intervention by time interaction, and the time-by-group interaction was assessed using a likelihood ratio test.|Baseline, 1, 2, 3, and 6 months|All participants with at least one follow-up data (n=116) were included in the analysis||units on a scale||Standard Deviation|Mean
653817|NCT01975948|Primary|Between Group Changes in Total Score on the Opening Minds Scale for Health Care Providers (OMS-HC)|The Opening Minds Scale for Health Care Providers (OMS-HC) is a 15 item validated scale that also captures three main dimensions of stigma; negative attitudes, health professionals’ own willingness to disclose/seek help for a mental illness, and preference for greater social distance. Items are rated on a 5-point scale: from strongly agree to strongly disagree. Total scores can range from 15 to 75 for the overall total score, 6 to 30, 4-29, 5-25 for sub-scales respectively. Total scores are averaged to result in mean scores range from 1 to 5 with lower scores indicating less stigma. This scale has been widely validated and used in evaluations of anti-stigma interventions in Canada. The analysis was conducted using a multi-level mixed model in which physicians were clustered within practices and stigma ratings were clustered within physicians (one or two observations per physician). The effect of the intervention was measured in this analysis as an intervention by time interaction.|Baseline and at 6 months|||units on a scale||Standard Deviation|Mean
653818|NCT01975948|Primary|Depression Severity (Change in Patient Health Questionnaire-9 (PHQ-9) Score From Baseline|The Patient Health Questionnaire-9 (PHQ-9) covers nine symptom-based Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for major depressive disorder. Scores range from 0-27, with higher scores indicating more severe depression severity. We compared between-group mean differences of PHQ-9 scores during follow-up, assessed as a group-by-time interaction. We used a multi-level mixed model analysis: physicians clustered within practices, patients clustered within their corresponding physicians, and longitudinal PHQ-9 ratings clustered within patients. The four follow-up time points were represented by indicator variables. The effect of the intervention was measured as an intervention by time interaction, and the time-by-group interaction was assessed using a likelihood ratio test.|Baseline, 1, 2, 3, and 6 months|All participants with at least one follow-up data (n=116) were included in the analysis||units on a scale||Standard Deviation|Mean
653819|NCT01975935|Secondary|Change in Weight|Change in weight (kilograms) as measured at baseline and week 12 visits.|12 week|The number of participants analyzed at week 12 differs from the overall number analyzed at baseline because 1 treatment group and 3 placebo group participants dropped from the study before their week 12 visit.||kilograms||Standard Deviation|Mean
653820|NCT01975935|Secondary|Hepatic Steatosis as Measured by MRI|Improvement in hepatic steatosis by MRI is shown by a decrease in percent fat from baseline to week 12 visit.|12 weeks|One placebo patient was an early termination and did not have an MRI scan done at the 12 week visit. A total of 20 patients received MRI scans due to funding limitations.||% fat||Standard Deviation|Mean
653821|NCT01975935|Primary|Difference in Hemoglobin A1c Values|Difference in hemoglobin A1c as measured at baseline and week 12 visits|12 weeks (measured at baseline and 12 weeks)|The number of participants analyzed at week 12 differs from the overall number analyzed at baseline because 1 treatment group and 3 placebo group participants dropped from the study before their week 12 visit.||percentage of hemoglobin glycated||Standard Deviation|Mean
653822|NCT01975909|Other Pre-specified|Percent Change From Baseline to Post Treatment on Mobility and Turning|"Mobility and turning is assessed by the timed up-and-go test (Podsiadlo & Richardson, 1991). The participant will be seated in an armed chair. On the word go, the subject will stand up using the arm rests if needed, walk (with assistive device if needed) around a cone placed three meters in front of the chair, return and sit down as quickly as possible."|Baseline and 1 week post treatment|||percentage change||Standard Deviation|Mean
653823|NCT01975909|Other Pre-specified|Percent Change From Baseline to Post Treatment on Standing Postural Control|Postural control - assessed by measuring standing postural sway (ie., center-of pressure fluctuations) during two, 30second trials of standing with eyes open on a stationary force platform (AMTI, Watertown, MA).|Baseline and 1 week post treatment|||percentage change||Standard Deviation|Mean
653824|NCT01975909|Other Pre-specified|Percent Change From Baseline to Post Treatment on Gait Speed in 90 Second Walking Test|Two 90 second trials of walking at a preferred speed along a 80x4m indoor hallway. A wireless Noraxon DTS system (Noraxon Inc, Scottsdale, AZ) will be used simultaneously and continuously record bilateral foot placements, 3-dimensional trunk accelerations, and lower-extremity surface electromyography of eight muscles.|Baseline and 1 week post treatment|||percentage change||Standard Deviation|Mean
653825|NCT01975909|Secondary|Percent Change From Baseline to Post Treatment on the 9-hole Peg Test|The test consists of a block with nine holes, into which the subject places and then removes 9 pegs. The time taken to complete the test will be recorded.|Baseline and 1 week post treatment|||percentage change||Standard Deviation|Mean
653826|NCT01975909|Secondary|Percent Change From Baseline to Post Treatment on the Timed 25-Foot Walk|A quantitative assessment of mobility and leg function. Two trials of patients walking along a 25ft course as quickly and safely as possible. Time taken to complete course will be recorded and averaged across trials.|Baseline and 1 week post treatment|||percentage change of maximum gait speed||Standard Deviation|Mean
653827|NCT01975909|Primary|Percent Change From Baseline to Post Treatment on the Scale for the Assessment and Rating of Ataxia (SARA)|Assess 8 items: gait, stance, sitting, speech, dysmetria, kinetic tremor, pro- and supinations of the hand, and the heel-shin slide. Each item is scored by the physician on a 4 to 8 numerical scale based upon the amount of dysfunction observed while performing the task. The maximum possible score for the total scale is 40. Lower scores of SARA represents better task performance.|Baseline and 1 week post treatment|||percentage change||Standard Deviation|Mean
653828|NCT01975675|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 12 weeks|Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug||percentage of participants|||Number
653829|NCT01975675|Secondary|Percentage of Participants Experiencing Virologic Failure|"Virologic failure was defined as
On-treatment virologic failure:
Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)
Virologic relapse:
- Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 24|Full Analysis Set||percentage of participants|||Number
653830|NCT01975675|Secondary|Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set||percentage of participants|||Number
653831|NCT01975675|Primary|Percentage of Participants With Sustained Virologic Response at 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set||percentage of participants|||Number
653832|NCT01975675|Primary|Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12), Treatment-naive, Noncirrhotic Participants|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Treatment-naive participants in the Full Analysis Set (randomized, received at least 1 dose of study drug, and had chronic genotype 1 (1a, 1b, or mixed 1a/1b) HCV infection) without cirrhosis were analyzed.||percentage of participants|||Number
653833|NCT01975467|Secondary|Range of Motion and Strength|The ASES instrument will be used to assess range of motion and strength.|One time point||||||
653834|NCT01975467|Primary|DASH Score|Subjects that are one to three years post-treatment will undergo an evaluation of fracture outcome utilizing the DASH instrument for function.|One time point|Terminated due to low enrollment|||||
653835|NCT01975285|Secondary|Patient Satisfaction With Pain Management|Patient satisfaction with pain management: measured using a Verbal Rating Scale (0-10) Verbal Rating Scale: 0 to 10 scale where 0 indicates= No satisfied at all 10 indicates= Extremely satisfied|3 days|||Scores on a scale||Standard Deviation|Mean
653836|NCT01975285|Secondary|Patient Satisfaction With Regional Nerve Block|Patient satisfaction with regional nerve block: measured using a Verbal Rating Scale (0-10) Verbal Rating Scale: 0 to 10 scale where 0 indicates= No satisfied at all 10 indicates= Extremely satisfied|3 days|||Scores on a scale||Standard Deviation|Mean
653837|NCT01975285|Secondary|Length of Analgesia|Time in days and/or hours|3 days|||Hours||Inter-Quartile Range|Median
653838|NCT01975285|Secondary|Opioid Consumption|Opioid consumption obtained from the recorded data Perioperative use of opioid consumption inside hospital (recorded by study staff and data obtained from patient charts)|3 days|||Opioids consumption mg||Standard Deviation|Mean
653839|NCT01975285|Primary|Postoperative Pain|"Postoperative pain will be measured using a Verbal Rating Scale (0-10) Verbal Rating Scale: 0 to 10 scale where 0 indicates= No pain and 10 indicates= The worst possible pain"|3 days|||Scores on a scale||Standard Deviation|Mean
653840|NCT01975246|Secondary|The Proportion of Patients With DBP<90 mmHg and SBP<140 mmHg as Seated Blood Pressure at Trough After 8 Weeks of the Double-blind Period|Patients with trough seated DBP =>90 mmHg or trough seated SBP >=140 mmHg at baseline were analysed.|baseline and week 8|FAS||percentage of participants||95% Confidence Interval|Number
653841|NCT01975246|Secondary|Change From Baseline in Mean Seated SBP at Trough After 8 Weeks of the Double-blind Period.|Change from baseline in mean seated systolic blood pressure (SBP) at trough after 8 weeks of the double-blind period. After patients had rested in a seated position for approximately 5 minutes, blood pressure was measured 3 times at approximately 2-minute intervals. The mean of the 3 measurements are used as endpoints.|baseline and week 8|FAS||mmHg||Standard Error|Mean
653842|NCT01975246|Primary|Change From Baseline in Mean Seated DBP at Trough After 8 Weeks of the Double-blind Period.|Change from baseline in mean seated diastolic blood pressure (DBP) at trough after 8 weeks of the double-blind period. After patients had rested in a seated position for approximately 5 minutes, blood pressure was measured 3 times at approximately 2-minute intervals. The mean of the 3 measurements are used as endpoints.|baseline and week 8|Full analysis set (FAS): This analysis set was, conforming to the intent-to-treat principle, defined as all patients i) included in the treated set; and ii) taking measurements of seated DBP at reference baseline and at 1 or more time points during the double-blind period.||mmHg||Standard Error|Mean
653843|NCT01975220|Secondary|AUC 0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity); Metformin|AUC 0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity); Metformin|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration|PKS: This set includes all subjects of the TS who provided at least one observation for at least one primary endpoint and had no important protocol violations with respect to the statistical evaluation of PK endpoints.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
653844|NCT01975220|Primary|Cmax (Maximum Measured Concentration of the Analyte in Plasma); Metformin|Cmax (maximum measured concentration of the analyte in plasma); Metformin|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration|PKS: This set includes all subjects of the TS who provided at least one observation for at least one primary endpoint and had no important protocol violations with respect to the statistical evaluation of PK endpoints.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
653845|NCT01975220|Primary|Cmax (Maximum Measured Concentration of the Analyte in Plasma); Empagliflozin|Cmax (maximum measured concentration of the analyte in plasma); Empagliflozin|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration|PKS: This set includes all subjects of the TS who provided at least one observation for at least one primary endpoint and had no important protocol violations with respect to the statistical evaluation of PK endpoints.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
653846|NCT01975220|Secondary|AUC 0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity); Empagliflozin|AUC 0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity); Empagliflozin|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration|PKS: This set includes all subjects of the TS who provided at least one observation for at least one primary endpoint and had no important protocol violations with respect to the statistical evaluation of PK endpoints.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
653847|NCT01975220|Primary|AUC 0-tz (Area Under the Concentration -Time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point); Metformin|AUC 0-tz (area under the concentration -time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point); Metformin|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration|PKS: This set includes all subjects of the TS who provided at least one observation for at least one primary endpoint and had no important protocol violations with respect to the statistical evaluation of PK endpoints.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
653848|NCT01975220|Primary|Area Under the Concentration -Time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC 0-tz); Empagliflozin|Area under the concentration -time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC 0-tz); Empagliflozin|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration|Pharmacokinetic set (PKS): This set includes all subjects of the Treated set (TS) who provided at least one observation for at least one primary endpoint and had no important protocol violations with respect to the statistical evaluation of Pharmacokinetic (PK) endpoints.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
653849|NCT01974895|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|"A serious adverse event was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.
Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010."|During the entire study period (Day 0 – Day 180)|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented and for whom safety data were available.||Subjects|||Number
653850|NCT01974895|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|"An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination
Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.
Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010"|During a 28-day follow-up period (i.e. day of vaccination and 27 subsequent days) after each vaccination|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented and for whom safety data were available.||Subjects|||Number
653851|NCT01974895|Secondary|Number of Subjects Reporting Any Potential Immune-Mediated Diseases (pIMDs)|"pIMDs were defined as a subset of adverse events that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which might or might not have an autoimmune aetiology. Any pIMD was defined as at least one pIMD experienced by the study subject. Related pIMD was defined as a pIMD assessed by the investigator to be causally related to the study vaccination.
Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.
Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010."|During the entire study period (Day 0 to Day 180)|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented and for whom safety data were available.||Subjects|||Number
653852|NCT01974895|Secondary|Number of Subjects Reporting Any Medically Attended Adverse Events (MAEs)|"MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s). Related was defined as a MAE assessed by the investigator to be causally related to the study vaccination.
Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.
Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010."|During the entire study period (Day 0 to Day 180)|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented and for whom safety data were available.||Subjects|||Number
653853|NCT01974895|Secondary|Duration of Solicited Local and General Symptoms|"Duration was defined as number of days with any grade of local and general symptoms.
Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.
Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010."|During a 7-day follow-up period (i.e. day of vaccination and six subsequent days) after each vaccination|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented and for whom safety data were available.||Days||Full Range|Median
653854|NCT01974895|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Fever|"Any fever was defined as any fever ≥38.0 degrees Celsius (°C) irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 fever was defined as fever ≥39.0 °C.
Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.
Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010."|During a 4-day follow-up period (i.e. day of vaccination and 3 subsequent days) after each vaccination|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented and for whom safety data were available.||Subjects|||Number
653855|NCT01974895|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.|"Solicited general symptoms assessed were drowsiness, irritability/fussiness and loss of appetite. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 irritability/fussiness was defined as crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite was defined as not eating at all. Grade 3 drowsiness was defined as drowsiness that prevented normal activity.Grade 3 fever was defined as axillary temperature above 39.0°C.
Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.
Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010."|During a 7-day follow-up period (i.e. day of vaccination and six subsequent days) after each vaccination|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented and for whom safety data were available.||Subjects|||Number
653856|NCT01974895|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.|"Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain was defined as pain that made the subject cry when limb was moved/spontaneously painful. Grade 3 swelling was greater than 100 millimeters (mm) i.e. >100mm.
Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.
Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010."|During a 7-day follow-up period (i.e. day of vaccination and six subsequent days) after each vaccination|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented and for whom safety data were available.||Subjects|||Number
653857|NCT01974895|Secondary|Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the Four Vaccine Influenza Strains.|"MGI was defined as the fold increase in serum haemagglutination inhibition (HI) GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/2/2012 (Yamagata), Flu B/Brisbane/60/2008 (Victoria).
Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.
Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010."|28 days after the last vaccine dose (at Day 28 for primed subjects and at Day 56 for unprimed subjects)|Analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Fold increase||95% Confidence Interval|Geometric Mean
653858|NCT01974895|Secondary|Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Four Vaccine Influenza Strains.|"A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/2/2012 (Yamagata), Flu B/Brisbane/60/2008 (Victoria).
Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.
Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010."|At Day 0 (for all subjects) and Day 28 after last vaccine dose (Day 28 for primed subjects and Day 56 for unprimed subjects)|Analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
653859|NCT01974895|Secondary|Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Influenza Strains|"HI antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/2/2012 (Yamagata), Flu B/Brisbane/60/2008 (Victoria).
Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.
Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010."|On Day 0 and 28 days after the last vaccine (Day 28 and Day 56 for primed and unprimed subjects respectively)|Analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Titers||95% Confidence Interval|Geometric Mean
671887|NCT01680549|Secondary|Patient Restfulness|Percentage of self reported patient restfulness was recorded on postoperative days 0, 1 and 2.|3 days|||Percent(%) of participants|||Number
653860|NCT01974895|Secondary|Number of Seroconverted Subjects for HI Antibodies Against Each of the Four Vaccine Influenza Strains.|"A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.
The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/2/2012 (Yamagata), Flu B/Brisbane/60/2008 (Victoria). This outcome concerns solely subjects in the Fluzone Group.
Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.
Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010."|28 days after the last vaccine dose (at Day 28 for primed subjects and at Day 56 for unprimed subjects)|Analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
653861|NCT01974895|Primary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains of FluLaval® Quadrivalent Vaccine.|"A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.
The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/2/2012 (Yamagata), Flu B/Brisbane/60/2008 (Victoria). This outcome concerns solely subjects in the FluLaval Quadrivalent Group.
Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.
Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010."|28 days after the last vaccine dose (at Day 28 for primed subjects and at Day 56 for unprimed subjects)|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
653862|NCT01974817|Primary|Change From Baseline in Antibody Concentrations After 13-valent Conjugate Pneumococcal Vaccination in in Patients 50 Years or Older With End Stage Renal Disease on Dialysis|Study the immunologic response after administration of single dose 13-valent conjugate pneumococcal vaccine in patients 50 years or older with end stage renal disease on dialysis.|12 months|||µg/ml||95% Confidence Interval|Geometric Mean
653863|NCT01974752|Secondary|Assessment of the Overall Survival (OS) in Patients Taking Selumetinib in Combination With Dacarbazine Compared With Those Taking Placebo in Combination With Dacarbazine|Overall Survival|From Randomization, up until death assessed up to 15th May 2015|All randomised patients and will compare the treatment groups on the basis of randomised treatment, regardless of the treatment actually received. Note, this is also known as the Full Analysis set (FAS).||Number of Overall Survival Events|||Number
653864|NCT01974752|Secondary|Assessment of the Efficacy of Selumetinib in Combination With Dacarbazine Compared With Placebo in Combination With Dacarbazine in Terms of Change in Tumour Size at Week 6 by BICR|Percent change in tumour size at Week 6 using BICR according to RECIST 1.1|From Randomization, then every 6 weeks up until progression or death (whichever is sooner) assessed up to 15th May 2015|All randomised patients and will compare the treatment groups on the basis of randomised treatment, regardless of the treatment actually received. Note, this is also known as the Full Analysis set (FAS).||percent change||Standard Deviation|Mean
653865|NCT01974752|Secondary|Assessment of the Efficacy of Selumetinib in Combination With Dacarbazine Compared With Placebo in Combination With Dacarbazine in Terms of Objective Response Rate (ORR) by BICR|ORR at Week 6 using BICR according to RECIST 1.1|From Randomization, then every 6 weeks up until progression or death (whichever is sooner) assessed up to 15th May 2015|Full Analysis Set||number of responders|||Number
653866|NCT01974752|Primary|Assessment of the Efficacy of Selumetinib in Combination With Dacarbazine Compared With Placebo in Combination With Dacarbazine Measured as Progression Free Survival (PFS) Using BICR According to RECIST 1.1.|Progression free survival (PFS) using blinded independent central review (BICR) according to the Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1). Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|From Randomization, then every 6 weeks up until progression or death (whichever is sooner) assessed up to 15th May 2015|All randomised patients and will compare the treatment groups on the basis of randomised treatment, regardless of the treatment actually received. Note, this is also known as the Full Analysis set (FAS).||number of progression events|||Number
653867|NCT01974700|Secondary|Number of Participants Who Returned to Work|The number who had returned to work in the timeframe of 6-12 months, inclusion of those that returned to part-time.|6 months - 12 months|||participants|||Number
653868|NCT01974700|Secondary|Number of Participants Who Returned to Daily Activities.|The number who had returned to daily activities in the timeframe of 6-12 months, inclusion of those that returned to most of daily activities.|6 months - 12 months|||participants|||Number
653869|NCT01974700|Primary|Incidence of Seizure|Reported via patient in follow-up phone call.|6 mo - 1 Year from Operative Procedure|||participants|||Number
653870|NCT01974323|Secondary|Percentage of Patients Reporting at Least a 1-Grade Improvement From Baseline in Facial Redness on a the 5-Point ASIS Scale|The patient assessed their facial redness using item 8 on the 5-point ASIS. Item 8 scores ranged from 0 (Not at all red) to 4 (Very red). The percentage of patients who reported at least a 1-grade improvement from baseline in their facial redness are reported.|Baseline, Week 12|Intent-to-Treat: all randomized patients||Percentage of Patients|||Number
653871|NCT01974323|Secondary|Percentage of Patients Reporting at Least a 1-Grade Improvement From Baseline in Facial Oiliness on a the 5-Point ASIS Scale|The patient assessed their facial oiliness using item 1 on the 5-point ASIS. Item 1 scores ranged from 0 (Not at all oily) to 4 (Very oily). The percentage of patients who reported at least a 1-grade improvement from baseline in their facial oiliness are reported.|Baseline, Week 12|Intent-to-Treat: all randomized patients||Percentage of Patients|||Number
671888|NCT01680549|Secondary|Knee Range of Motion|Patient knee range of motion was assessed on postoperative days 0, 1 and 2.|3 days|||Degrees||Standard Deviation|Mean
653872|NCT01974323|Secondary|Change From Baseline in the 9-Item ASIS Sign Domain Score|The patient assessed signs of acne vulgaris using the ASIS. The sign domain is a composite of 9 items of the 17 items on the overall scale. Each of the items is assessed on a 5-point scale: 0 (best) to 4 (worst). The sign domain score is calculated as the average of the 9 items for a total possible score of 0 to 4. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.|Baseline, Week 12|Intent-to-Treat: all randomized patients||Scores on a Scale||Standard Deviation|Mean
653873|NCT01974323|Secondary|"Percentage of Patients Reporting Very Good or Excellent on Item 10 of the 5-Point Acne Symptom Impact Scale (ASIS)"|The patient assessed the impact of their acne vulgaris on the look of their face using item 10 on the 5-point ASIS. Item 10 scores range from 1 (Excellent) to 5 (Bad). The percentage of patients who had an ASIS score of 4 (Fair) or 5 (Bad) at baseline and who reported “Very good” or “Excellent” at Week 12 are reported.|Week 12|Intent-to-Treat: all randomized patients with data at this time point||Percentage of Patients|||Number
653874|NCT01974323|Secondary|Percentage Change From Baseline in Total Lesion Counts|The Investigator evaluated the patient's Inflammatory (papule, pustule and nodule/cyst) and Non-inflammatory (blackhead and whitehead) lesions. A papule is a small, red, solid elevation less than 1.0 cm in diameter, a pustule is a small, circumscribed elevation of the skin that contains yellow-white exudate and a nodule/cyst is a circumscribed, elevated, solid lesion generally more than 0.5 cm in diameter with palpable depth. The total lesion count was the sum of the inflammatory and non-inflammatory lesion counts. A negative percent change from baseline indicates a reduction in lesion counts (improvement) and a positive percent change from baseline indicates an increase in lesion counts (worsening).|Baseline, Week 12|Intent-to-Treat: all randomized patients||Percent Change in Lesion Count||Standard Error|Least Squares Mean
653875|NCT01974323|Secondary|Change From Baseline in Total Lesion Counts|The Investigator evaluated the patient's inflammatory (papule, pustule and nodule/cyst) and non-inflammatory (blackhead and whitehead) lesions. A papule is a small, red, solid elevation less than 1.0 cm in diameter, a pustule is a small, circumscribed elevation of the skin that contains yellow-white exudate and a nodule/cyst is a circumscribed, elevated, solid lesion generally more than 0.5 cm in diameter with palpable depth. The total lesion count was the sum of the inflammatory and non-inflammatory lesion counts. A negative change from baseline indicates a reduction in lesion counts (improvement) and a positive change from baseline indicates an increase in lesion counts (worsening).|Baseline, Week 12|Intent-to-Treat: all randomized patients||Total Lesion Counts||Standard Error|Least Squares Mean
653876|NCT01974323|Primary|Change From Baseline in Noninflammatory Facial Lesion Counts|The Investigator evaluated the patient's noninflammatory lesions (papule, pustule and nodule/cyst). A negative change from baseline indicates a reduction in lesion counts (improvement) and a positive change from baseline indicates an increase in lesion counts (worsening).|Baseline, Week 12|Intent-to-Treat: all randomized patients||Number of Noninflammatory Lesions||Standard Error|Mean
653877|NCT01974323|Primary|Change From Baseline in Inflammatory Facial Lesion Counts|The Investigator evaluated the patient's inflammatory lesions (papule, pustule and nodule/cyst). A negative change from baseline indicates a reduction in lesion counts (improvement) and a positive change from baseline indicates an increase in lesion counts (worsening).|Baseline, Week 12|Intent-to-Treat: all randomized patients||Number of Inflammatory Lesions||Standard Error|Mean
653878|NCT01974323|Primary|Percentage of Patients With a Score of 0 (None) or 1 (Minimal) on the 5-point Global Acne Assessment Score (GAAS)|The Investigator evaluated the patient's acne severity using the 5-point GAAS scale with 0 being none and 4 being severe. The complete scale is as follow: Grade 0 (none) = No evidence of facila acne vulgaris; Grade 1 (minimal) = Few noninflammatory lesions (comedones) are present, a few inflammatory lesions (papules/pustules) may be present, no nodulo-cyctic lesions are allowed; Grade 2 (mild) = Several to many noninflammatory lesions (comedones) are present, a few inflammatory lesions (papules/pustules) are present, no nodulo-cystic lesions are allowed; Grade 3 (moderate) = Many noninflammatory (comedones) and inflammatory lesions (papules/pustules) are present, no nodulo-cystic lesions are allowed; Grade 4 (severe) = Significant degree of inflammatory disease, papules/pustules are a predominant feature, a few nodulo-cystic lesions may be present, comedones may be present.|Week 12|Intent-to-Treat: all randomized patients||Percentage of Patients|||Number
653879|NCT01974245|Other Pre-specified|Change From Baseline in Expression in Monocytes of Vitamin D Receptor, α 1-hydroxylase and 24-hydroxylase Enzymes, and Interleukin-6 at 12 Weeks||12 weeks||||||
653880|NCT01974245|Secondary|Change From Baseline in C-reactive Protein at 12 Weeks||12 weeks||||||
653881|NCT01974245|Primary|Change From Baseline in Interleukin-6 at 12 Weeks.||12 weeks|||pg/mL||Standard Deviation|Mean
653882|NCT01974141|Secondary|Percentage of Patients Reporting at Least a 1-Grade Improvement From Baseline in Facial Redness on a the 5-Point ASIS Scale|The patient assessed their facial redness using item 8 on the 5-point ASIS. Item 8 scores ranged from 0 (Not at all red) to 4 (Very red). The percentage of patients who reported at least a 1-grade improvement from baseline in their facial redness are reported.|Baseline, Week 12|Intent-to-Treat: all randomized patients, excluding patients from a site with Good Clinical Practice violations||Percentage of Patients|||Number
653883|NCT01974141|Secondary|Percentage of Patients Reporting at Least a 1-Grade Improvement From Baseline in Facial Oiliness on a the 5-Point ASIS Scale|The patient assessed their facial oiliness using item 1 on the 5-point ASIS. Item 1 scores ranged from 0 (Not at all oily) to 4 (Very oily). The percentage of patients who reported at least a 1-grade improvement from baseline in their facial oiliness are reported.|Baseline, Week 12|Intent-to-Treat: all randomized patients, excluding patients from a site with Good Clinical Practice violations||Percentage of Patients|||Number
653884|NCT01974141|Secondary|Change From Baseline in the 9-Item ASIS Sign Domain Score|The patient assessed signs of acne vulgaris using the ASIS. The sign domain is a composite of 9 items of the 17 items on the overall scale. Each of the items is assessed on a 5-point scale: 0 (best) to 4 (worst). The sign domain score is calculated as the average of the 9 items for a total possible score of 0 to 4. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.|Baseline, Week 12|Intent-to-Treat: all randomized patients, excluding patients from a site with Good Clinical Practice violations||Scores on a Scale||Standard Deviation|Mean
654103|NCT01969799|Secondary|Composite Endpoint of Mortality and Ventilator-free Days|The hierarchical composite endpoint of mortality, then ventilator-free days. The table reflects winners of matched pairs, ties are not noted.|Day 1- Day 28|MITT||participants|||Number
653885|NCT01974141|Secondary|"Percentage of Patients Reporting Very Good or Excellent on Item 10 of the 5-Point Acne Symptom Impact Scale (ASIS)"|The patient assessed the impact of their acne vulgaris on the look of their face using item 10 on the 5-point ASIS. Item 10 scores range from 1 (Excellent) to 5 (Bad). The percentage of patients who had an ASIS score of 4 (Fair) or 5 (Bad) at baseline and who reported “Very good” or “Excellent” at Week 12 are reported.|Week 12|Intent-to-Treat: all randomized patients with data at this time point, excluding patients from a site with Good Clinical Practice violations||Percentage of Patients|||Number
653886|NCT01974141|Secondary|Percentage Change From Baseline in Total Lesion Counts|The Investigator evaluated the patient's Inflammatory (papule, pustule and nodule/cyst) and Non-inflammatory (blackhead and whitehead) lesions. A papule is a small, red, solid elevation less than 1.0 cm in diameter, a pustule is a small, circumscribed elevation of the skin that contains yellow-white exudate and a nodule/cyst is a circumscribed, elevated, solid lesion generally more than 0.5 cm in diameter with palpable depth. The total lesion count was the sum of the inflammatory and non-inflammatory lesion counts. A negative percent change from baseline indicates a reduction in lesion counts (improvement) and a positive percent change from baseline indicates an increase in lesion counts (worsening).|Baseline, Week 12|Intent-to-Treat: all randomized patients, excluding patients from a site with Good Clinical Practice violations||Percent Change in Lesion Count||Standard Error|Least Squares Mean
653887|NCT01974141|Secondary|Change From Baseline in Total Lesion Counts|The Investigator evaluated the patient's inflammatory (papule, pustule and nodule/cyst) and non-inflammatory (blackhead and whitehead) lesions. A papule is a small, red, solid elevation less than 1.0 cm in diameter, a pustule is a small, circumscribed elevation of the skin that contains yellow-white exudate and a nodule/cyst is a circumscribed, elevated, solid lesion generally more than 0.5 cm in diameter with palpable depth. The total lesion count was the sum of the inflammatory and non-inflammatory lesion counts. A negative change from baseline indicates a reduction in lesion counts (improvement) and a positive change from baseline indicates an increase in lesion counts (worsening).|Baseline, Week 12|Intent-to-Treat: all randomized patients, excluding patients from a site with Good Clinical Practice violations||Total Lesion Counts||Standard Error|Least Squares Mean
653888|NCT01974141|Primary|Change From Baseline in Noninflammatory Facial Lesion Counts|The Investigator evaluated the patient's noninflammatory lesions (papule, pustule and nodule/cyst). A negative change from baseline indicates a reduction in lesion counts (improvement) and a positive change from baseline indicates an increase in lesion counts (worsening).|Baseline, Week 12|Intent-to-Treat: all randomized patients, excluding patients from a site with Good Clinical Practice violations||Number of Noninflammatory Lesions||Standard Error|Mean
653889|NCT01974141|Primary|Change From Baseline in Inflammatory Facial Lesion Counts|The Investigator evaluated the patient's inflammatory lesions (papule, pustule and nodule/cyst). A negative change from baseline indicates a reduction in lesion counts (improvement) and a positive change from baseline indicates an increase in lesion counts (worsening).|Baseline, Week 12|Intent-to-Treat: all randomized patients, excluding patients from a site with Good Clinical Practice violations||Number of Inflammatory Lesions||Standard Error|Mean
653890|NCT01974141|Primary|Percentage of Patients With a Score of 0 (None) or 1 (Minimal) on the 5-point Global Acne Assessment Score (GAAS)|The Investigator evaluated the patient's acne severity using the 5-point GAAS scale with 0 being none and 4 being severe. The complete scale is as follow: Grade 0 (none) = No evidence of facila acne vulgaris; Grade 1 (minimal) = Few noninflammatory lesions (comedones) are present, a few inflammatory lesions (papules/pustules) may be present, no nodulo-cyctic lesions are allowed; Grade 2 (mild) = Several to many noninflammatory lesions (comedones) are present, a few inflammatory lesions (papules/pustules) are present, no nodulo-cystic lesions are allowed; Grade 3 (moderate) = Many noninflammatory (comedones) and inflammatory lesions (papules/pustules) are present, no nodulo-cystic lesions are allowed; Grade 4 (severe) = Significant degree of inflammatory disease, papules/pustules are a predominant feature, a few nodulo-cystic lesions may be present, comedones may be present.|Week 12|Intent-to-Treat: all randomized patients, excluding patients from a site with Good Clinical Practice violations||Percentage of Patients|||Number
653891|NCT01973777|Secondary|Acceptability|patient-reported acceptability|12 months|||participants|||Number
653892|NCT01973777|Secondary|Complication|infection, perforation, pregnancy|12 months|||participants|||Number
653893|NCT01973777|Primary|Expulsion Rate|The device being expelled from the uterus as documented by ultrasound or by seeing the actual device outside the uterus|at 6-8 weeks|||participants|||Number
653894|NCT01973608|Secondary|Number of Subjects With Treatment-Emergent Adverse Events (AEs) or Serious AEs|TEAE was defined as an AE that started on or after the first administration of SBRT. An SAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/ significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.|Screening up to 28 days after last dose of drug; assessed up to maximum of 1.41 years|Safety analysis set included all subjects who signed informed consent, were enrolled into the study and received at least 1 dose of MSB0010445.||subjects|||Number
653895|NCT01973608|Secondary|Number of Subjects With Best Overall Response (BOR) According to Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1|BOR was defined as a confirmed complete response (CR) or partial response (PR) during second-line treatment. For target lesions (TLs), CR was defined as the disappearance of all TLs, and PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD. For non-target lesions (NTLs), CR was defined as the disappearance of all NTLs and normalization of tumor marker levels.|Screening up to 28 days after last dose of drug; assessed up to maximum of 1.41 years|"Safety analysis set included all subjects who signed informed consent, were enrolled into the study and received at least 1 dose of MSB0010445. Here Number of Participants Analyzed signifies those subjects who were evaluable for this outcome measure."||subjects|||Number
653939|NCT01973218|Secondary|The ELISA Geometric Mean Concentrations (GMCs) Against Vaccine Antigen 287-953, by Vaccine Group.|The GMCs against vaccine antigen 287-953 was measured by Enzyme-linked Immunosorbent Assay (ELISA) , at one month after second vaccination and are reported for each group.|Day 1 and Day 61|Analysis was done on FAS population, i.e. all subjects who received at least one study vaccine and had immunogenicity data at relevant timepoints||IU/mL||95% Confidence Interval|Geometric Mean
654546|NCT01965288|Primary|Overall Sensation of Moistness|Participant rating for overall sensation of moistness. Collected at baseline for all habitual lenses. (5-point Likert Scale; Excellent, Good, Average, Below Average)|Baseline|||percentage of subjects|||Number
653896|NCT01973608|Primary|Number of Subjects With at Least 1 Dose Limiting Toxicity (DLT)|DLT was defined as any Grade>= 3 toxicity related to drug, occurring during 21 days post first dose of drug except Grade 3 infusion-related adverse reaction resolving within 6 hours and Transient (<=6 hours) Grade 3 flu-like symptoms/fever controlled with medical management; Transient (<= 24 hours) Grade 3 fatigue, local reactions, headache, nausea, emesis that resolved to <= Grade 1; Grade 3 skin toxicity ,Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) < 8 x upper limit of normal (ULN)/total bilirubin < 5 x ULN resolving to <= Grade 1 in <7 days after medical management; Grade 3 diarrhea controlled with maximal medical management within 72 hours; Grade 4 lymphopenia that resolves to <= Grade 1 within 7 days & with no clinical manifestations; Grade 3 lab abnormality with no clinical correlation and resolves to <= Grade 1 within 7 days with adequate medical management Tumor flare defined as local pain, irritation or rash localized at sites of known/suspected tumor.|Baseline up to Day 21|Safety analysis set included all subjects who signed informed consent, were enrolled into the study and received at least 1 dose of MSB0010445.||subjects|||Number
653897|NCT01973595|Secondary|Diet Quality|"Three dietary recalls occurred per study arm, and each recall was scored for quality. The quality scores were averaged per arm and then compared between study arms for each subject/group using the Healthy Eating Index-2010.The Healthy Eating Index assesses diet quality based on 12 components, when summed has maximum points of 100 (HEI scale 0-100).
High component scores indicate intakes close to the recommended ranges or amounts; low component scores indicate less compliance with the recommended ranges or amounts.
National averages total score: children: 54.9 [4-8 years] and adults: 57.4 [31-50 years])"|Three week almond intervention vs. three week no almond intervention|29 Parents and 29 children were analyzed separately for almonds and no almond consumption; one parent-child pair withdrew prior to no almond consumption control.||units on a scale||Standard Error|Mean
653898|NCT01973595|Secondary|Gastrointestinal Function|Changes in average number of stools per week were measured using a Daily Questionnaire. Results were compared between treatment periods for each subject/group.|Pre-baseline (Week 0) and Week 3 of each intervention|29 parents and 29 children consumed almonds n=58; one parent-child pair withdrew prior to no almond consumption control intervention n=56; parents and children were analyzed for almonds and no almond consumption.||average stools per week||Standard Error|Mean
653899|NCT01973595|Secondary|Inflammatory Status|Levels of inflammatory markers in the blood (IL-6) were compared between baseline and final time points once the participants were on the Almonds intervention.. The data were collected at Baseline and Week four.|Change between Baseline to Week 4|Parents (Almonds baseline, n=29, final n=29, No almonds baseline n=28, final n= 28; one parent withdrew prior to no almond consumption control intervention) were analyzed for almonds and no almond consumption, no children were included in this analysis.||ng/ml||Standard Error|Mean
653900|NCT01973595|Primary|Gut Microbiota Community Composition|The mean of the change between baseline and final time points in stool lactic acid bacteria counts [log(CFU)] was compared for each study arm.|Baseline #1 (Week 1) to Final #1 (Week 4) of each intervention|Stool samples were analyzed only if all 4 were available from each participant. Therefore, only data from 21 parents and 20 children were analyzed.||log (CFU)||Standard Error|Mean
653901|NCT01973491|Secondary|Number of Subjects Experiencing Injection Site Reactions (ISRs)|Treatment-emergent ISRs were defined as any ISR with a start date on or after the date of first dose and within 7 days after the date of last dose in the current study. Injection site reactions were identified as erythema, induration, pruritus, nodules and/or cysts, ecchymosis, pain and local edema.|Baseline up to Week 22|The SAF Analysis Set included all subjects who received at least 1 dose of IMP.||subjects|||Number
653902|NCT01973491|Secondary|Number of Subjects With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death, TEAEs Leading to Discontinuation|An adverse event (AE) was defined as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the study drug. An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent adverse events are defined as any adverse event with a start date on or after the date of first dose and within 28 days after the date of last dose in the current study. TEAEs include both Serious TEAEs and non-serious TEAEs.|Baseline up to Week 25|The SAF Analysis Set included all subjects who received at least 1 dose of IMP.||subjects|||Number
653903|NCT01973491|Secondary|Change From Baseline in Total Multiple Sclerosis Functional Composite (MSFC) Score at Week 20|The MSFC is a multidimensional clinical outcome measure which consists of three sub-tests; Timed 25-Foot Walk, 9-Hole Peg Test and Paced Auditory Serial Addition Test-3(PASAT-3). The Timed 25-Foot Walk is a quantitative measure of lower extremity function. The 9-Hole Peg Test is a quantitative measure of upper extremity (arm and hand) function. The PASAT is a measure of cognitive function that specifically assesses auditory information processing speed and flexibility, as well as calculation ability. Standardized results (Z-scores) of these sub-tests and the overall MSFC Z-score as an average of these three Z-scores was calculated. Higher Z-scores reflect better neurological function and a positive change from baseline indicates improvement. An increase in score indicates an improvement (range -3 to +3). Baseline was defined as the last measurement taken prior to the first dose of study drug (Week 0).|Baseline (Week 0) and Week 20|"The mITT analysis set. Here, Number Analyzed signifies those subjects who were evaluable at the specified time point."||Z-score||Standard Deviation|Mean
653904|NCT01973491|Secondary|Change From Baseline in Total Expanded Disability Status Scale (EDSS) Score at Week 20|EDSS is an ordinal scale in half-point increments that qualifies disability in subjects with Multiple Sclerosis. It consists of 8 ordinal rating scales assessing seven functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as any other neurological findings due to Multiple Sclerosis. Total EDSS score ranges from 0 (normal neurological examination) to 10 (death due to MS). Baseline was defined as the last measurement taken prior to the first dose of study drug (Week 0).|Baseline (Week 0) and Week 20|"The mITT analysis set. Here, Number Analyzed signifies those subjects who were evaluable at the specified time point."||units on a scale||Standard Deviation|Mean
671889|NCT01680549|Secondary|Narcotics Consumption|Narcotics consumption was recorded on postoperative days 0, 1, and 2.|3 days|||Morphine dose equivalents||Standard Deviation|Mean
653905|NCT01973491|Secondary|Time to First Relapse|Relapse was defined as new, worsening or recurrent neurological symptoms attributed to multiple sclerosis that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days. These new or worsening symptoms should be noted by the subject and must be accompanied by at least one of the following: An increase of greater than or equal to (>=) 1 grade in >=2 functional scales of the Expanded Disability Status Scale (EDSS) or an increase of >=2 grades in 1 functional scale of the EDSS or an increase of >= 0.5 or an increase of >=1.0 in EDSS if the previous EDSS was 0. Time to first relapse was defined as the time in days from the date of first dose of study treatment to the date of first multiple sclerosis relapse.|Baseline up to Week 36|The mITT analysis set included all enrolled subjects who received at least 1 dose of IMP and had 2 or more MRI scans during the Baseline Control Period and planned on-treatment visits (Weeks 12, 16, and 20) or end of treatment visit provided it occurred within 28 days of the last dose of IMP.||days||95% Confidence Interval|Median
653906|NCT01973491|Secondary|Mean Annualized Relapse Rate|Relapse was defined as new, worsening or recurrent neurological symptoms attributed to multiple sclerosis that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days. These new or worsening symptoms should be noted by the subject and must be accompanied by at least one of the following: An increase of greater than or equal to (>=) 1 grade in >=2 functional scales of the Expanded Disability Status Scale (EDSS) or an increase of >=2 grades in 1 functional scale of the EDSS or an increase of >= 0.5 or an increase of >=1.0 in EDSS if the previous EDSS was 0. Annualized Relapse Rate was calculated as = 365.25 x (Number of relapses during Treatment Period) per (Number of days on treatment during Treatment Period).|Week 20|Analysis population included subset of mITT analysis set who had relapse.||relapse per year||Standard Deviation|Mean
653907|NCT01973491|Secondary|Change From Week 0 in Total Volume of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs) at Weeks 12, 16, 20, 24, 28 and 36|T1 CELs were measured using MRI scans.|Weeks 0, 12, 16, 20, 24, 28 and 36|The mITT analysis set. Here, “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure and “Number Analyzed” signifies those subjects who were evaluable at the specified time point.||milliliter||Standard Deviation|Mean
653908|NCT01973491|Secondary|Change From Week 0 in Total Number of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs) at Weeks 12, 16, 20, 24, 28 and 36|T1 CELs were measured using MRI scans.|Week 0, 12, 16, 20, 24, 28 and 36|"The mITT analysis set. Here, Number of participants analyzed signifies those subjects who were evaluable for this outcome measure and Number Analyzed signifies those subjects who were evaluable at the specified time point."||lesions||Standard Deviation|Mean
653909|NCT01973491|Secondary|Total Number of New or Newly Enlarging Time Constant 2 (T2) Lesions|T2 lesions were measured using MRI scans.|Weeks 12, 16, 20, 24, 28 and 36|"The mITT analysis set. Here, Number Analyzed signifies those subjects who were evaluable at the specified time point."||lesions||Standard Deviation|Mean
653910|NCT01973491|Secondary|Change From Baseline in Total Volume of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs) at Weeks 12, 16, 20, 24, 28 and 36|T1 CELs were measured using MRI scans. Baseline was calculated as the average number of T1 CELs during the 3 visits in the Baseline Control Period (Weeks -8, -4 and 0).|Baseline (Weeks -8, -4, 0), Week 12, 16, 20, 24, 28 and 36|"The mITT analysis set. Here, Number Analyzed signifies those subjects who were evaluable at the specified time point."||milliliter||Standard Deviation|Mean
653911|NCT01973491|Secondary|Change From Baseline in Total Number of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs) at Weeks 12, 16, 20, 24, 28 and 36|T1 CELs were measured using MRI scans. Baseline was calculated as the average number of T1 CELs during the 3 visits in the Baseline Control Period (Weeks -8, -4 and 0).|Baseline (Weeks -8, -4 and 0), Weeks 12, 16, 20, 24, 28 and 36|The mITT analysis set. Here, “Number Analyzed” signifies those subjects who were evaluable at the specified time point.||lesions||Standard Deviation|Mean
653912|NCT01973491|Secondary|Total Number of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs)|The number of T1 CELs were measured using MRI scans.|Weeks 12, 16, 20, 24, 28 and 36|The mITT analysis set. Here, “Number Analyzed” signifies those subjects who were evaluable at the specified time point.||lesions||Standard Deviation|Mean
653913|NCT01973491|Primary|Change From Baseline in the Average Number of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs) Over On-treatment Scans|T1 CELs were measured using Magnetic Resonance Imaging (MRI) scans. Baseline value was calculated as the average number of T1 CELs during the 3 visits in the Baseline Control Period (Weeks -8, -4 and 0) and On-treatment value was calculated as the average number of T1 CELs during the 3 visits in the treatment period (Weeks 12, 16 and 20). The change from baseline in average number of T1 CELs was reported.|Baseline (Weeks -8, -4 and 0), Treatment Period (Weeks 12, 16 and 20)|The modified intention-to-treat (mITT) analysis set included all enrolled subjects who received at least 1 dose of IMP and had 2 or more MRI scans during the Baseline Control Period and planned on-treatment visits (Weeks 12, 16, and 20) or end of treatment visit provided it occurred within 28 days of the last dose of IMP.||lesions||Standard Deviation|Mean
653914|NCT01973439|Primary|Cmax of Abacavir on Once Daily Dosing|Blood samples were taken at 0 (pre-dose), 1, 2, 3, 4, 6, 8, 12 and 24 hours post-ingestion of medication.|Week 4|||mg/L||95% Confidence Interval|Geometric Mean
653915|NCT01973439|Primary|AUC(0-24) of Abacavir on Once Daily Dosing|Blood samples were taken at 0 (pre-dose), 1, 2, 3, 4, 6, 8, 12 and 24 hours post-ingestion of medication|Week 4|||h*mg/L||95% Confidence Interval|Geometric Mean
653916|NCT01973439|Primary|Cmax of Abacavir on Twice Daily Dosing|Blood samples were taken at 0 (pre-dose), 1, 2, 3, 4, 6, 8 and 12 hours post-ingestion of medication.|Week 0|||mg/L||95% Confidence Interval|Geometric Mean
653917|NCT01973439|Primary|Area Under Curve (AUC) (0-24) of Abacavir on Twice Daily Dosing|Blood samples were taken at 0 (pre-dose), 1, 2, 3, 4, 6, 8 and 12 hours post-ingestion of medication.|Week 0|||h*mg/L||95% Confidence Interval|Geometric Mean
653940|NCT01973218|Secondary|The Percentages of Subjects With a Four-fold Increase in SBA Antibody Titers Against N.Meningitidis Serogroup B, by Vaccine Group.|Percentages of subjects with a four-fold increase in SBA antibody titers from baseline against each of the three indicator strains of N.Meningitidis serogroup B, at one month after second vaccination are reported, for each group.|Day 61|Analysis was done on FAS population, i.e. all subjects who received at least one study vaccine and had immunogenicity data at relevant timepoints.||percentage of subjects||95% Confidence Interval|Number
653918|NCT01973413|Secondary|Glycemic Events|"Number of nights with >= 1 hypo- and hyperglycemic event occurring overnight during the camp study.
Participants were randomized to either closed-loop (experimental) or sensor-augmented pump therapy (control) for the first night and then crossed over every other night to the other therapy over the course of the 5- to 6-day camp session. Thus there were ~60 nights of data for each intervention. However, data from closed-loop nights during which there were technical problems such as infusion set failure, sensor error >20%, or pump failure resulting in a >60-min interruption to closed-loop control were removed to allow for analysis of algorithm performance. Only nights with a minimum of 5 hours of closed-loop were included, and all glucose data were included in the analysis. For comparison, only data from nights during which sensor error was, <20% with a minimum of 5 hours were included in the control group."|6 nights|Data from OCL nights during which there were technical problems (infusion set failure, sensor error >20%, pump failure with >60-min interruption to closed-loop) were removed. Only nights with a minimum of 5h of OCL were included. For control, only data from nights where sensor error was <20% with a minimum of 5h were included.||nights with >= 1 event|Participants||Number
653919|NCT01973413|Secondary|Overnight Glucose|"Mean overnight glucose during camp study.
Participants were randomized to either closed-loop (experimental) or sensor-augmented pump therapy (control) for the first night and then crossed over every other night to the other therapy over the course of the 5- to 6-day camp session. Thus there were ~60 nights of data for each intervention. However, data from closed-loop nights during which there were technical problems such as infusion set failure, sensor error >20%, or pump failure resulting in a >60-min interruption to closed-loop control were removed to allow for analysis of algorithm performance. Only nights with a minimum of 5 hours of closed-loop were included, and all glucose data were included in the analysis. For comparison, only data from nights during which sensor error was, <20% with a minimum of 5 hours were included in the control group."|6 nights|Data from OCL nights during which there were technical problems (infusion set failure, sensor error >20%, pump failure with >60-min interruption to closed-loop) were removed. Only nights with a minimum of 5h of OCL were included. For control, only data from nights where sensor error was <20% with a minimum of 5h were included.||mg/dL|Participants|Standard Deviation|Mean
653920|NCT01973413|Primary|Percent Time Near Normoglycemia|"Percent of time in a glucose target range of 70-150 mg/dl during camp study.
Participants were randomized to either closed-loop (experimental) or sensor-augmented pump therapy (control) for the first night and then crossed over every other night to the other therapy over the course of the 5- to 6-day camp session. Thus there were ~60 nights of data for each intervention. However, data from closed-loop nights during which there were technical problems such as infusion set failure, sensor error >20%, or pump failure resulting in a >60-min interruption to closed-loop control were removed to allow for analysis of algorithm performance. Only nights with a minimum of 5 hours of closed-loop were included, and all glucose data were included in the analysis. For comparison, only data from nights during which sensor error was, <20% with a minimum of 5 hours were included in the control group."|6 nights|Data from OCL nights during which there were technical problems (infusion set failure, sensor error >20%, pump failure with >60-min interruption to closed-loop) were removed. Only nights with a minimum of 5h of OCL were included. For control, only data from nights where sensor error was <20% with a minimum of 5h were included.||percentage of time|Participants|Inter-Quartile Range|Median
653921|NCT01973387|Secondary|Number of Participants With Disease-Related Symptom Improvement|The most common disease-related symptoms associated with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) (fatigue, weight loss, fevers, night sweats, and abdominal discomfort/splenomegaly) were reported by grade.|From the date of randomization to disease progression (Up to 3.7 years)||02/2018||||
653922|NCT01973387|Secondary|Number of Participants With Sustained Hematologic Improvement|Sustained hematologic improvement was defined as hematological improvement that was sustained continuously for greater than or equal to (>=) 56 days without blood transfusion or growth factors: 1) Platelet counts greater than (>)100* 109/liter (L) if baseline less than or equal to (<=) 100*109/L or increase >= 50 percent (%) over baseline; 2) Hemoglobin >11 gram per deciliters (g/dL) if baseline <= 11 g/dL or increase >= 2 g/dL over baseline.|From the date of randomization to disease progression (Up to 3.7 years)||02/2018||||
653923|NCT01973387|Secondary|Overall Survival (OS)|Overall survival was defined as the interval between the date of randomization and the date of death from any cause.|From the date of randomization to the date of death (Up to 3.7 years)|Intent-to-Treat (ITT) analysis set is defined as all participants randomized into the study and analyzed according to assigned treatment group, regardless of the actual treatment received.||months||95% Confidence Interval|Median
653924|NCT01973387|Secondary|Overall Response Rate (ORR)|ORR defined as number of participants achieving a complete response (CR), complete response with incomplete marrow recovery (CRi), nodular partial response (nPR) or partial response (PR). IWCLL 2008 criteria: CR- No lymphadenopathy and hepatosplenomegaly, no constitutional symptoms, neutrophils >1.5*10^9/liter (L), platelets >100*10^9/L, Hgb >11 gram per deciliter (g/dL) and absolute lymphocyte count <4000/microliter (mcL); CRi- CR with incomplete recovery of bone marrow; nPR- participants meet criteria for CR, but the bone marrow biopsy shows B-lymphoid nodules, may represent a clonal infiltrate; PR- >=50% drop in lymphocyte count from baseline or <=4.0*10^9/L with following: >=50% decrease in sum products of up to 6 lymph nodes, no new enlarged lymph nodes, When abnormal, >=50% decrease in enlargement of spleen from baseline or normalization and a response in 1 of following: Neutrophils >1.5*10^9/L, Platelets>100000/mcL and Hgb>11 g/dL or >=50% improvement over baseline in all.|From the date of randomization to disease progression (Up to 3.7 years)|Intent-to-Treat (ITT) analysis set is defined as all participants randomized into the study and analyzed according to assigned treatment group, regardless of the actual treatment received.||participants|||Number
653941|NCT01973218|Secondary|The Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination SBA Titers Against N.Meningitidis Serogroup B, by Vaccine Group.|The GMR of post-vaccination versus pre-vaccination SBA titers against each of the three indicator strains of N.Meningitidis serogroup B, at one month after second vaccination (day 61/day 1) are reported, for each group.|Day 61/ Day 1|Analysis was done on the FAS population, i.e. all subjects who received at least one study vaccine and had immunogenicity data at relevant timepoints||Ratio||95% Confidence Interval|Geometric Mean
653964|NCT01972776|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval, Tau (AUCtau) (Part 1)|Venous blood samples were collected for concentration-time profiles.|day 1 (from pre-dose to 12 hours post dose)|All Part 1 participants who received active treatment.||ng*h/mL||Standard Deviation|Mean
653925|NCT01973387|Primary|Progression-free Survival (PFS)|Progression-free survival was defined as the interval between the date of randomization and the date of disease progression or death, whichever was first reported. International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 criteria for progressive disease (PD): New enlarged nodes greater than (>)1.5 centimeter (cm), new hepatomegaly or splenomegaly, or other organ infiltrates; greater than or equal to (>=)50 percent (%) increase from nadir in existing lymph node or >=50% increase from nadir in sum of product of diameters of multiple nodes; >=50% increase from nadir in enlargement of liver or spleen; >=50% increase from baseline in lymphocyte count (and to >=5*10^9/L) unless considered treatment-related lymphocytosis; New cytopenia (Hemoglobin b [Hgb] or platelets) attributable to chronic lymphocytic leukemia (CLL) and transformation to a more aggressive histology.|From the date of randomization to the date of disease progression or death, whichever was first reported (Up to 3.7 years)|Intent-to-Treat (ITT) analysis set is defined as all participants randomized into the study and analyzed according to assigned treatment group, regardless of the actual treatment received.||months||95% Confidence Interval|Median
653926|NCT01973348|Other Pre-specified|Significant Ocular Deviation Increase From the Baseline|The significant ocular deviation is defined as equal or over 10 degrees of deviation more than that of the baseline.|3 Months|||Participants|||Count of Participants
653927|NCT01973348|Other Pre-specified|Reverse Amblyopia|it is defined that the strong eye of the patient decreases two logMAR lines over 3 months.|3 Months|||Participants|||Count of Participants
653928|NCT01973348|Primary|Visual Acuity Change During 12 Weeks|Visual acuity change during 12 weeks: the difference of visual acuity at baseline and 12 weeks.|12 weeks|Visual acuity change over 12 weeks||logMAR||Standard Deviation|Mean
653929|NCT01973231|Secondary|Number of Treatment Emergent Adverse Events (TEAEs)|A Treatment Emergent Adverse Event (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. Severity was assessed by investigator.|Weeks 0-26|The safety analysis set (SAS) included all subjects who received at least one dose of any of the trial products.||events|||Number
653930|NCT01973231|Secondary|Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) and no Weight Gain (Yes/no)|Subjects who achieved HbA1c below 7.0% (53 mmol/mol) and no weight gain after 26 weeks of treatment (yes/no).|After 26 weeks of treatment|The FAS included all randomised subjects. Missing values were imputed using predicted values from the MMRM model. Due to missing HbA1c post-baseline data, 194 and 191 subjects in liraglutide and lixisenatide treatment group, respectively were included in the HbA1c analysis.||percentage (%) of subjects|||Number
653931|NCT01973231|Secondary|Subjects Who Achieve HbA1c Equal to or Below 6.5% (48 mmol/Mol) (American Association of Clinical Endocrinologists [AACE] Target) (Yes/no)|Subjects who achieved HbA1c below equal to or below 6.5% (48 mmol/mol) after 26 weeks of treatment (yes/no).|After 26 weeks of treatment|The FAS included all randomised subjects. Missing values were imputed using predicted values from the MMRM model. Due to missing HbA1c post baseline data, 194 and 191 subjects in liraglutide and lixisenatide treatment group, respectively were included in the HbA1c analysis.||percentage (%) of subjects|||Number
653932|NCT01973231|Secondary|Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) (American Diabetes Association (ADA) Target) (Yes/no)|Subjects who achieved HbA1c below 7.0% (53 mmol/mol) after 26 weeks of treatment (yes/no).|After 26 weeks of treatment|The FAS included all randomised subjects. Missing values were imputed using predicted values from the MMRM model. Due to missing HbA1c post baseline data, 194 and 191 subjects in liraglutide and lixisenatide treatment group, respectively were included in the HbA1c analysis.||percentage (%) of subjects|||Number
653933|NCT01973231|Secondary|Change in Body Weight From Baseline|Change from baseline in body weight after 26 weeks of treatment.|Week 0, week 26|The FAS included all randomised subjects. Missing values were imputed using predicted values from the MMRM model. Due to missing body weight post baseline data, 194 and 191 subjects in liraglutide and lixisenatide treatment group, respectively were included in the body weight analysis.||kg||Standard Deviation|Mean
653934|NCT01973231|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline|Change from baseline in FPG after 26 weeks of treatment.|Week 0, week 26|The FAS included all randomised subjects. Missing values were imputed using predicted values from the MMRM model. Due to missing FPG post baseline data, 194 and 189 subjects in liraglutide and lixisenatide treatment group, respectively were included in the FPG analysis.||mmol/L||Standard Deviation|Mean
653935|NCT01973231|Primary|Change in Glycosylated Haemoglobin (HbA1c) From Baseline|Change from baseline in HbA1c after 26 weeks of treatment.|Week 0, week 26|The full analysis set (FAS) included all randomised subjects. Missing values were imputed using predicted values from the mixed model for repeated measurements (MMRM) model. Due to missing HbA1c post baseline data, 194 and 191 subjects in liraglutide and lixisenatide treatment group, respectively were included in the HbA1c analysis.||Percent (%) glycosylated haemoglobin||Standard Deviation|Mean
653936|NCT01973218|Secondary|The Number of Subjects Reporting Unsolicited AEs After Any Vaccination, by Vaccine Group.|The number of subjects reporting any unsolicited AEs, serious adverse events (SAEs), AEs leading to premature withdrawal and medically attended AEs (throughout the study), following rMenB+OMV NZ vaccination or placebo/MenACWY-CRM, are reported.|Day 1 through Day 61|Analysis was done on the safety set for solicited AEs i.e all subjects in the Exposed Set who received the correct vaccination and provide post vaccination reactogenicity data.||number of subjects|||Number
653937|NCT01973218|Secondary|The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group.|The number of subjects reporting solicited local and systemic adverse events (AEs) following rMenB+OMV NZ vaccination or placebo/MenACWY-CRM, are reported.|Day 1 through day 7 after each vaccination|Analysis was done on the safety set for solicited AEs i.e all subjects in the Exposed Set who received the correct vaccination and provide post vaccination reactogenicity data.||Number of subjects|||Number
653938|NCT01973218|Secondary|The GMR of Post Versus Pre-vaccination ELISA GMCs Against Vaccine Antigen 287-953, by Vaccine Groups.|The GMR of post versus pre-vaccination GMCs against vaccine antigen 287-953, measured by ELISA at one month after second vaccination (day 61/day 1) are reported for each group.|Day 61/Day 1|Analysis was done on FAS population, i.e. all subjects who received at least one study vaccine and had immunogenicity data at relevant timepoints.||Ratio||95% Confidence Interval|Geometric Mean
653961|NCT01972776|Secondary|Cmax,ss (Part 1)|Venous blood samples were collected for concentration-time profiles.|day 14 (from pre-dose to 72 hours post dose)|All Part 1 participants who received active treatment.||ng/mL||Standard Deviation|Mean
653942|NCT01973218|Secondary|The SBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B, by Vaccine Group.|The SBA antibody titers against each of the three indicator strains of N.Meningitidis serogroup B at one month after second vaccination are reported as GMTs, for each group.|Day 1 and Day 61|Analysis was done on FAS population, i.e. all subjects who received at least one study vaccine and had immunogenicity data at relevant timepoints.||Titers||95% Confidence Interval|Geometric Mean
653943|NCT01973218|Primary|Percentage of Subjects With Serum Bactericidal Antibody (SBA) Titers ≥1:4 Against Neisseria Meningitidis Serogroup B by Vaccine Group.|Percentage of subjects with SBA titers ≥1:4 against each of the three indicators strains H44/76, 5/99 and NZ98/254 of N. Meningitidis serogroup B, at one month after second vaccination, are reported for each group.|Day 1 and Day 61|Analysis was done on the Full Analysis Set (FAS) i.e. all subjects who received at least one study vaccine and had immunogenicity data at relevant timepoints.||percentage of subjects||95% Confidence Interval|Number
653944|NCT01973205|Secondary|Number of Subjects Who Are Free of Phonophobia at the 2-hour Assessment.|Number of subjects who are free of phonophobia at the 2-hour assessment.|2 hours|Number of participants analyzed includes only subjects who treated a migraine (AA: N=408, Placebo: N = 415) and had a non-missing phonophobia free status at 2 hours (AA: N=403, Placebo: N = 411).||participants|||Number
653945|NCT01973205|Secondary|Number of Subjects Who Are Free of Photophobia at the 2-hour Assessment.|Number of subjects who are free of photophobia at the 2-hour assessment.|2 hours|Number of participants analyzed includes only subjects who treated a migraine (AA: N=408, Placebo: N = 415) and had a non-missing photophobia free status at 2 hours (AA: N=403, Placebo: N = 411).||participants|||Number
653946|NCT01973205|Primary|Number of Subjects Who Are Nausea Free at the 2-hour Assessment|Number of subjects who are nausea free at the 2-hour assessment|2 hours|Number of participants analyzed includes only subjects who treated a migraine (AA: N=408, Placebo: N=415) and had a non-missing nausea free status at 2 hours (AA: N=403, Placebo N= 411).||participants|||Number
653947|NCT01973205|Primary|Number of Subjects Who Are Pain Free at the 2-hour Assessment|Number of subjects who are pain free at the 2-hour assessment|2 hours|Number of participants analyzed includes only subjects who treated a migraine (AA: N=408, Placebo: N = 415) and had a non-missing pain free status at 2 hours (AA: N=408, Placebo: N = 415).||participants|||Number
653948|NCT01972776|Secondary|Change From Baseline in Scond/Sacin as Measured by Multiple Breath Nitrogen Washout (MBNW) (Part 2)||baseline, day 56|Part 2 was terminated early. Therefore, primary and secondary outcomes for part 2 were not assessed.|||||
653949|NCT01972776|Secondary|Change From Baseline in Diffusing Capacity of the Lung for Carbon Monoxide (DLco) (Part 2)||baseline, day 56|Part 2 was terminated early. Therefore, primary and secondary outcomes for part 2 were not assessed.|||||
653950|NCT01972776|Secondary|Change From Baseline in Percentage Sputum Neutrophils (Part 2)||baseline, day 56|Part 2 was terminated early. Therefore, primary and secondary outcomes for part 2 were not assessed.|||||
653951|NCT01972776|Secondary|Tmax Between 0h and 24h (Part 2)||day 1, day 56|Part 2 was terminated early. Therefore, primary and secondary outcomes for part 2 were not assessed.|||||
653952|NCT01972776|Secondary|Cmax Between 0h and 24h (Part 2)||day 1, day 56|Part 2 was terminated early. Therefore, primary and secondary outcomes for part 2 were not assessed.|||||
653953|NCT01972776|Secondary|AUC0-24 (Part 2)||day 1, day 56|Part 2 was terminated early. Therefore, primary and secondary outcomes for part 2 were not assessed.|||||
653954|NCT01972776|Secondary|Change From Baseline in Forced Expirtory Flow 25-75 (FEF25-75), Forced Expiratory Volume 3 (FEV3)/Forced Vital Capacity (FVC), 1-(FEV3/FVC), FEV6, FEV1/FEV6 and Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) (Part 2)||baseline, day 56|Part 2 was terminated early. Therefore, primary and secondary outcomes for part 2 were not assessed.|||||
653955|NCT01972776|Secondary|Change From Baseline in Lung Clearance Index 2.5 (LCI2.5) (Part 1)|Lung clearance index (LCI) is a measure of abnormal ventilation distribution derived from the multiple breath inert gas washout (MBW) technique. LCI is equal to the cumulative expired volume/functional residual capacity. LCI was measured at baseline and day 14. LCI was analyzed using a Bayesian model for repeated measurements. The model may investigate effects for pre-dose baseline, treatment, time, age, COPD class, treatment by time interaction, and baseline by time interaction. A positive change from baseline indicates improvement.|baseline, day 14 pre-dose|All Randomized Part 1 participants were considered for the analysis but participants with both baseline and day 14 values were analyzed.||index score||Standard Error|Mean
653956|NCT01972776|Secondary|Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Part 1)|FEV1 is the amount of air that can be exhaled in one second. FEV1 will be measured by spirometry and performed at approximately the same time of day on each visit to avoid diurnal variation. All spirometry calibrations and evaluations followed the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability. A positive change from baseline in FEV1 indicates improvement in lung function.|baseline, day 14 pre-dose|All Randomized Part 1 participants were considered for the analysis but participants with both baseline and day 14 values were analyzed.||mL||Standard Error|Mean
653957|NCT01972776|Secondary|Change From Baseline in Chemokine (C-X-C Motif) Receptor 2 (CXCR2) Receptor Occupancy (Part 1)|Whole blood samples were taken by either direct venipuncture or an indwelling cannula inserted in a forearm vein in order to measure CXCR2 receptor occupancy on neutrophils. A positive change from baseline indicates improvement.|baseline, day 14|All Randomized Part 1 participants were considered for the analysis but participants with both baseline and day 14 values were analyzed.||percent change|||Number
653958|NCT01972776|Secondary|Change From Baseline in Cluster of Differentiation 11b (CD11b) (Part 1)|Whole blood samples were taken by either direct venipuncture or an indwelling cannula inserted in a forearm vein in order to measure CD11b expression on neutrophils. A negative change from baseline indicates improvement.|baseline, day 14|All Randomized Part 1 participants were considered for the analysis but participants with both baseline and day 14 values were analyzed.||percentage change|||Number
653959|NCT01972776|Secondary|Tmax,ss (Part 1)|Venous blood samples were collected for concentration-time profiles.|day 14 (from pre-dose to 72 hours post dose)|All Part 1 participants who received active treatment.||hours||Full Range|Median
653960|NCT01972776|Secondary|Time to Reach the Maximum Concentration After Drug Administration (Tmax) (Part 1)|Venous blood samples were collected for concentration-time profiles.|day 1 (from pre-dose to 12 hours post dose)|All Part 1 participants who received active treatment.||hours||Full Range|Median
653974|NCT01972516|Secondary|Quality of Life (QOL) Evaluation|To evaluate the impact of treatment with Tivozanib versus placebo alone on the Quality of Life (QOL) through the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the EORTC QLQ-Ovarian Cancer Module (EORTC QLQ-OV28) for functioning and symptoms.|2 Years|Outcome measure not analyzed due to low accrual and subsequent termination of the study.|||||
653975|NCT01972516|Secondary|Toxicity Rate Comparison|To compare rates of toxicity with and without maintenance therapy with Tivozanib.|2 Years|Outcome measure not analyzed due to low accrual and subsequent termination of the study.|||||
653976|NCT01972516|Secondary|Overall Survival (OS) Evaluation|To evaluate the overall survival with and without maintenance therapy with Tivozanib in patients who have achieved a complete response following therapy for platinum sensitive disease.|2 Years|Outcome measure not analyzed due to low accrual and subsequent termination of the study.|||||
653977|NCT01972516|Secondary|Progression-Free Survival (PFS) Evaluation|To evaluate progression-free survival with no maintenance therapy in patients who have achieved a complete response following therapy for platinum sensitive disease.|2 Years|Outcome measure not analyzed due to low accrual and subsequent termination of the study.|||||
653978|NCT01972516|Primary|Progression-Free Survival (PFS) Comparison|"To compare progression-free survival of maintenance therapy with Tivozanib against standard of care in patients with ovarian, fallopian tube or primary peritoneal carcinoma who have achieved a complete response following therapy for platinum sensitive disease.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1)"|2 Years|Reporting the number of cycles each patient completed. Each cycle = 4 weeks.||Cycles|||Number
653979|NCT01972438|Secondary|Mean Change in Tear Composition (Tear Osmolarity) in the Fellow Eye at 6 Months Compared to Baseline|The fellow eye is the untreated eye. The tear composition test consists of the measurement of tear osmolarity using the Tearlab Osmolarity System (San Diego, California) by collecting a small 50 nanoliter (nL) tear sample which, with the use of laboratory test calculations, can derive the tear osmolarity in milliosmole per liter (mOsm/L).|Baseline and 6 Months|Twelve participants completed the first crossover treatment period at Month 3. Thirteen participants completed the second crossover treatment period at Month 6.||mOsm/L|eyes|Standard Deviation|Mean
653980|NCT01972438|Secondary|Mean Change in Tear Composition (Tear Osmolarity) in the Fellow Eye at 3 Months Compared to Baseline|The fellow eye is the untreated eye. The tear composition test consists of the measurement of tear osmolarity using the Tearlab Osmolarity System (San Diego, California) by collecting a small 50 nanoliter (nL) tear sample which, with the use of laboratory test calculations, can derive the tear osmolarity in milliosmole per liter (mOsm/L).|Baseline and 3 Months|Twelve participants completed the first crossover treatment period at Month 3.||mOsm/L|eyes|Standard Deviation|Mean
653981|NCT01972438|Secondary|Mean Change in Tear Composition (Tear Osmolarity) in the Study Eye at 6 Months Compared to Baseline|The tear composition test consists of the measurement of tear osmolarity using the Tearlab Osmolarity System (San Diego, California) by collecting a small 50 nanoliter (nL) tear sample which, with the use of laboratory test calculations, can derive the tear osmolarity in milliosmole per liter (mOsm/L).|Baseline and 6 Months|Twelve participants completed the first crossover treatment period at Month 3. Thirteen participants completed the second crossover treatment period at Month 6.||mOsm/L|eyes|Standard Deviation|Mean
653982|NCT01972438|Secondary|Mean Change in Tear Composition (Tear Osmolarity) in the Study Eye at 3 Months Compared to Baseline|The tear composition test consists of the measurement of tear osmolarity using the Tearlab Osmolarity System (San Diego, California) by collecting a small 50 nanoliter (nL) tear sample which, with the use of laboratory test calculations, can derive the tear osmolarity in milliosmole per liter (mOsm/L).|Baseline and 3 Months|Twelve participants completed the first crossover treatment period at Month 3.||mOsm/L|eyes|Standard Deviation|Mean
653983|NCT01972438|Secondary|Mean Change in Tear Stability (Tear Break-up Time) in the Fellow Eye at 6 Months Compared to Baseline|The fellow eye is the untreated eye. Sodium fluorescein dye was added to the eye and the tear film was observed under the slit lamp while the participant avoided blinking until tiny dry spots develop. Three measurements were taken and averaged for a more reproducible score.|Baseline and 6 Months|Twelve participants completed the first crossover treatment period at Month 3. Thirteen participants completed the second crossover treatment period at Month 6.||seconds|eyes|Standard Deviation|Mean
653984|NCT01972438|Secondary|Mean Change in Tear Stability (Tear Break-up Time) in the Study Eye at 6 Months Compared to Baseline|Sodium fluorescein dye was added to the eye and the tear film was observed under the slit lamp while the participant avoided blinking until tiny dry spots develop. Three measurements were taken and averaged for a more reproducible score.|Baseline and 6 Months|Twelve participants completed the first crossover treatment period at Month 3. Thirteen participants completed the second crossover treatment period at Month 6.||seconds|eyes|Standard Deviation|Mean
653985|NCT01972438|Secondary|Mean Change in Tear Stability (Tear Break-up Time) in the Fellow Eye at 3 Months Compared to Baseline|The fellow eye is the untreated eye. Sodium fluorescein dye was added to the eye and the tear film was observed under the slit lamp while the participant avoided blinking until tiny dry spots develop. Three measurements were taken and averaged for a more reproducible score.|Baseline and 3 Months|Twelve participants completed the first crossover treatment period at Month 3.||seconds|eyes|Standard Deviation|Mean
653986|NCT01972438|Secondary|Mean Change in Tear Stability (Tear Break-up Time) in the Study Eye at 3 Months Compared to Baseline|Sodium fluorescein dye was added to the eye and the tear film was observed under the slit lamp while the participant avoided blinking until tiny dry spots develop. Three measurements were taken and averaged for a more reproducible score.|Baseline and 3 Months|Twelve participants completed the first crossover treatment period at Month 3.||seconds|eyes|Standard Deviation|Mean
653987|NCT01972438|Secondary|Mean Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) in the Fellow Eye at 6 Months Compared to Baseline.|The fellow eye is the untreated eye. Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 6 Months|Twelve participants completed the first crossover treatment period at Month 3. Thirteen participants completed the second crossover treatment period at Month 6.||ETDRS letters|eyes|Standard Deviation|Mean
653988|NCT01972438|Secondary|Mean Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) in the Study Eye at 6 Months Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 6 Months|Twelve participants completed the first crossover treatment period at Month 3. Thirteen participants completed the second crossover treatment period at Month 6.||ETDRS letters|eyes|Standard Deviation|Mean
653989|NCT01972438|Secondary|Mean Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) in the Fellow Eye at 3 Months Compared to Baseline|The fellow eye is the untreated eye. Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 3 Months|Twelve participants completed the first crossover treatment period at Month 3.||ETDRS letters|eyes|Standard Deviation|Mean
653990|NCT01972438|Secondary|Mean Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) in the Study Eye at 3 Months Compared to Baseline.|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 3 Months|Twelve participants completed the first crossover treatment period at Month 3.||ETDRS letters|eyes|Standard Deviation|Mean
653991|NCT01972438|Secondary|Mean Change in the Chronic Ocular GVHD Composite Assessment Scale (CAS) Score in the Fellow Eye at 6 Months Compared to Baseline|"The fellow eye is the untreated eye. The CAS score is the sum of the scores on three separate assessments: Schirmer’s tear test without anesthesia, punctate keratopathy and conjunctival inflammation and scarring (scored according to Robinson et. al*). Each assessment was scored 0-3 with 0 = none, 1 = mild, 2 = moderate and 3 = severe. The higher values represent a worse outcome. The CAS score was a number between 0-9 with the higher number representing a worse outcome.
*Robinson MR, Lee SS, Rubin BI, Wayne AS, Pavletic SZ, Bishop MR, Childs R, Barrett AJ, Csaky KG. Topical Corticosteroid Therapy for Cicatricial Conjunctivitis Associated with Chronic Graft Versus Host Disease. Bone Marrow Transplant. 2004; 18:567-9."|Baseline and 6 Months|Twelve participants completed the first crossover treatment period at Month 3. Thirteen participants completed the second crossover treatment period at Month 6.||scores on a scale|eyes|Standard Deviation|Mean
653992|NCT01972438|Secondary|Mean Change in the Chronic Ocular GVHD Composite Assessment Scale (CAS) Score in the Study Eye at 6 Months Compared to Baseline|"The CAS score is the sum of the scores on three separate assessments: Schirmer’s tear test without anesthesia, punctate keratopathy and conjunctival inflammation and scarring (scored according to Robinson et. al*). Each assessment was scored 0-3 with 0 = none, 1 = mild, 2 = moderate and 3 = severe. The higher values represent a worse outcome. The CAS score was a number between 0-9 with the higher number representing a worse outcome.
*Robinson MR, Lee SS, Rubin BI, Wayne AS, Pavletic SZ, Bishop MR, Childs R, Barrett AJ, Csaky KG. Topical Corticosteroid Therapy for Cicatricial Conjunctivitis Associated with Chronic Graft Versus Host Disease. Bone Marrow Transplant. 2004; 18:567-9."|Baseline and 6 Months|Twelve participants completed the first crossover treatment period at Month 3. Thirteen participants completed the second crossover treatment period at Month 6.||scores on a scale|eyes|Standard Deviation|Mean
653993|NCT01972438|Secondary|Mean Change in the Chronic Ocular GVHD Composite Assessment Scale (CAS) Score in the Fellow Eye at 3 Months Compared to Baseline|"The fellow eye is the untreated eye. The CAS score is the sum of the scores on three separate assessments: Schirmer’s tear test without anesthesia, punctate keratopathy and conjunctival inflammation and scarring (scored according to Robinson et. al*). Each assessment was scored 0-3 with 0 = none, 1 = mild, 2 = moderate and 3 = severe. The higher values represent a worse outcome. The CAS score was a number between 0-9 with the higher number representing a worse outcome.
*Robinson MR, Lee SS, Rubin BI, Wayne AS, Pavletic SZ, Bishop MR, Childs R, Barrett AJ, Csaky KG. Topical Corticosteroid Therapy for Cicatricial Conjunctivitis Associated with Chronic Graft Versus Host Disease. Bone Marrow Transplant. 2004; 18:567-9."|Baseline and 3 Months|Twelve participants completed the first crossover treatment period at Month 3.||scores on a scale|eyes|Standard Deviation|Mean
653994|NCT01972438|Secondary|Mean Change in the Chronic Ocular GVHD Composite Assessment Scale (CAS) Score in the Study Eye at 3 Months Compared to Baseline|"The CAS score is the sum of the scores on three separate assessments: Schirmer’s tear test without anesthesia, punctate keratopathy and conjunctival inflammation and scarring (scored according to Robinson et. al*). Each assessment was scored 0-3 with 0 = none, 1 = mild, 2 = moderate and 3 = severe. The higher values represent a worse outcome. The CAS score was a number between 0-9 with the higher number representing a worse outcome.
*Robinson MR, Lee SS, Rubin BI, Wayne AS, Pavletic SZ, Bishop MR, Childs R, Barrett AJ, Csaky KG. Topical Corticosteroid Therapy for Cicatricial Conjunctivitis Associated with Chronic Graft Versus Host Disease. Bone Marrow Transplant. 2004; 18:567-9."|Baseline and 3 Months|Twelve participants completed the first crossover treatment period at Month 3.||scores on a scale|eyes|Standard Deviation|Mean
653995|NCT01972438|Secondary|Mean Change in the Combined Score of the Modified Oxford Punctate Keratopathy Grading and the NIH Visual Analogue Scale in the Fellow Eye at 6 Months Compared to Baseline|The fellow eye is the untreated eye. Oxford punctate keratopathy is an objective measure from 0-5 (cornea only) and the NIH/NEI visual analogue scale is a subjective grading performed by the participant regarding his/her ocular dryness, redness and irritation (scored 0-3 for each symptom with 0 = none, 1 = mild, 2 = moderate and 3 = severe for a total score between 0-9). The combined score was a number between 0-14 with the higher number representing a worse outcome.|Baseline and 6 Months|Twelve participants completed the first crossover treatment period at Month 3. Thirteen participants completed the second crossover treatment period at Month 6.||scores on a scale|eyes|Standard Deviation|Mean
654007|NCT01972152|Secondary|Glucose AUCex|Pharmacodynamic parameter: Area Under the Glucose Excursion Curve|Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection|Per protocol analysis set. Two subjects were excluded from all analyses: one who completed no treatment visits and had no evaluable data and another who violated eligibility criteria. A third subject was excluded from analysis for the one treatment visit at which the subject's blood samples were inadvertently diluted with saline during collection.||min*mg/dL||Standard Deviation|Mean
653996|NCT01972438|Secondary|Mean Change in the Combined Score of the Modified Oxford Punctate Keratopathy Grading and the NIH Visual Analogue Scale in the Study Eye at 6 Months Compared to Baseline|Oxford punctate keratopathy is an objective measure from 0-5 (cornea only) and the NIH/NEI visual analogue scale is a subjective grading performed by the participant regarding his/her ocular dryness, redness and irritation (scored 0-3 for each symptom with 0 = none, 1 = mild, 2 = moderate and 3 = severe for a total score between 0-9). The combined score was a number between 0-14 with the higher number representing a worse outcome.|Baseline and 6 Months|Twelve participants completed the first crossover treatment period at Month 3. Thirteen participants completed the second crossover treatment period at Month 6.||scores on a scale|eyes|Standard Deviation|Mean
653997|NCT01972438|Secondary|Mean Change in the Combined Score of the Modified Oxford Punctate Keratopathy Grading and the NIH Visual Analogue Scale in the Fellow Eye at 3 Months Compared to Baseline|The fellow eye is the untreated eye. Oxford punctate keratopathy is an objective measure from 0-5 (cornea only) and the NIH/NEI visual analogue scale is a subjective grading performed by the participant regarding his/her ocular dryness, redness and irritation (scored 0-3 for each symptom with 0 = none, 1 = mild, 2 = moderate and 3 = severe for a total score between 0-9). The combined score was a number between 0-14 with the higher number representing a worse outcome.|Baseline and 3 Months|Twelve participants completed the first crossover treatment period at Month 3.||scores on a scale|eyes|Standard Deviation|Mean
653998|NCT01972438|Secondary|Mean Change in the Combined Score of the Modified Oxford Punctate Keratopathy Grading and the NIH Visual Analogue Scale in the Study Eye at 3 Months Compared to Baseline|Oxford punctate keratopathy is an objective measure from 0-5 (cornea only) and the NIH/NEI visual analogue scale is a subjective grading performed by the participant regarding his/her ocular dryness, redness and irritation (scored 0-3 for each symptom with 0 = none, 1 = mild, 2 = moderate and 3 = severe for a total score between 0-9). The combined score was a number between 0-14 with the higher number representing a worse outcome.|Baseline and 3 Months|Twelve participants completed the first crossover treatment period at Month 3.||scores on a scale|eyes|Standard Deviation|Mean
653999|NCT01972438|Secondary|Number of Participants Withdrawn From the Study Treatment Due to Vision Loss, Adverse Events or Treatment Failure||Study Duration, up to 24 months|||participants|||Number
654000|NCT01972438|Secondary|Number of Systemic and Ocular Toxicities and Adverse Events||Study Duration, up to 24 months|||adverse events|||Number
654001|NCT01972438|Primary|Proportion of Participants Who Experienced a ≥ 50% Reduction in the Combined Score of the Modified Oxford Punctate Keratopathy Grading and the NIH/National Eye Institute (NEI) Visual Analogue Scale in the Study Eye From Baseline to Month 3.|A ≥ 50% reduction in the combined score was considered a treatment success. While the design is a crossover study, the primary outcome was assessed after the first period at Month 3. Oxford punctate keratopathy is an objective measure from 0-5 (cornea only) and the NIH/NEI visual analogue scale is a subjective grading performed by the participant regarding his/her ocular dryness, redness and irritation (scored 0-3 for each symptom with 0 = none, 1 = mild, 2 = moderate and 3 = severe for a total score between 0-9). The combined score was a number between 0-14 with the higher number representing a worse outcome.|Baseline and 3 months|This analysis is conducted on the per-protocol population, defined as those who adhered to the protocol prior to drug unavailability, not on the intent-to-treat population due to lack of visit information beyond baseline for 3 participants. Three never started drug: one was unable to donate blood, one was ineligible at screening and one died.||participants|eyes||Number
654002|NCT01972152|Secondary|Glucagon Tmax|Pharmacokinetic parameter: Time to maximum concentration of glucagon|Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection|Per protocol analysis set. Two subjects were excluded from all analyses: one who completed no treatment visits and had no evaluable data and another who violated eligibility criteria. A third subject was excluded from analysis for the one treatment visit at which the subject's blood samples were inadvertently diluted with saline during collection.||minutes||Standard Deviation|Mean
654003|NCT01972152|Secondary|Glucagon Cmax|Pharmacokinetic parameter: Maximum concentration of glucagon|Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection|Per protocol analysis set. Two subjects were excluded from all analyses: one who completed no treatment visits and had no evaluable data and another who violated eligibility criteria. A third subject was excluded from analysis for the one treatment visit at which the subject's blood samples were inadvertently diluted with saline during collection.||pg/ml||Standard Deviation|Mean
654004|NCT01972152|Secondary|Glucagon AUC|Pharmacokinetic parameter: Glucagon area under the curve from baseline to 240 minutes post-treatment|Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection|Per protocol analysis set. Two subjects were excluded from all analyses: one who completed no treatment visits and had no evaluable data and another who violated eligibility criteria. A third subject was excluded from analysis for the one treatment visit at which the subject's blood samples were inadvertently diluted with saline during collection.||min*pg/ml||Standard Deviation|Mean
654005|NCT01972152|Secondary|Glucose Tex|Pharmacodynamic parameter: Earliest reported time of MAE, based on within-subject changes from baseline|Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection|Per protocol analysis set. Two subjects were excluded from all analyses: one who completed no treatment visits and had no evaluable data and another who violated eligibility criteria. A third subject was excluded from analysis for the one treatment visit at which the subject's blood samples were inadvertently diluted with saline during collection.||minutes||Standard Deviation|Mean
654006|NCT01972152|Secondary|Glucose MAE|Pharmacodynamic parameter: Maximum absolute glucose excursion from baseline|Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection|Per protocol analysis set. Two subjects were excluded from all analyses: one who completed no treatment visits and had no evaluable data and another who violated eligibility criteria. A third subject was excluded from analysis for the one treatment visit at which the subject's blood samples were inadvertently diluted with saline during collection.||mg/dL||Standard Deviation|Mean
654040|NCT01971086|Secondary|Subjective Assessment of the Patient of Overall Treatment Tolerability at the Closing/Final Visit.|The efficacy of the treatment was rated by the patient at the closing/final visit.|up to day 11|Patients from TS||participants|||Number
655308|NCT01952665|Primary|Rewetting Drops|Participant use of rewetting drops. Collected at 4 weeks wear for both study lens pairs. (Uses rewetting drops / Does not use rewetting drops).|4 weeks|||participants|||Number
654008|NCT01972152|Secondary|Glucose Tmax|Pharmacodynamic parameter: Time to Maximum Glucose Concentration|Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection|Per protocol analysis set. Two subjects were excluded from all analyses: one who completed no treatment visits and had no evaluable data and another who violated eligibility criteria. A third subject was excluded from analysis for the one treatment visit at which the subject's blood samples were inadvertently diluted with saline during collection.||minutes||Standard Deviation|Mean
654009|NCT01972152|Secondary|Glucose Cmax|Pharmacodynamic parameter: Maximum concentration of glucose|Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection|Per protocol analysis set. Two subjects were excluded from all analyses: one who completed no treatment visits and had no evaluable data and another who violated eligibility criteria. A third subject was excluded from analysis for the one treatment visit at which the subject's blood samples were inadvertently diluted with saline during collection.||mg/dL||Standard Deviation|Mean
654010|NCT01972152|Secondary|Glucose Area Under the Curve (AUC)|Pharmacodynamic parameter: Glucose area under the curve from baseline to 240 minutes post-treatment|Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection|Per protocol analysis set. Two subjects were excluded from all analyses: one who completed no treatment visits and had no evaluable data and another who violated eligibility criteria. A third subject was excluded from analysis for the one treatment visit at which the subject's blood samples were inadvertently diluted with saline during collection.||min*mg/dL||Standard Deviation|Mean
654011|NCT01972152|Primary|Serious Adverse Events|Number of serious adverse events (SAEs) per treatment group|From first dose until completion of the post-treatment follow-up visit, up to 6 weeks|All subjects receiving treatment were included in this analysis.||events|||Number
654012|NCT01971723|Primary|Creatine-Kinase Outcomes||Baseline, 2-week mark, 4-week mark|||mkat/L||Standard Deviation|Mean
654013|NCT01971723|Primary|Sex-hormone Binding Globulin Outcomes||Baseline, 2-week mark, 4-week mark|||nmol/l||Standard Deviation|Mean
654014|NCT01971723|Primary|Cortisol Outcomes||Baseline, 2-week mark, 4-week mark|||ug/dl||Standard Deviation|Mean
654015|NCT01971723|Secondary|Volume Performance Outcomes|During the four weeks, the volume ((weight x reps)set 1+(weight x reps)set 2+ (weight x reps)set 3….. ) will be calculated and measured for each exercise in each lifting session.|4 Weeks|||Repetitions||Standard Deviation|Mean
654016|NCT01971723|Primary|Dihydrotestosterone Outcomes|Measurements for dihydrotestosterone (DHT) will occur on three occasions: prior to the start of supplementation and training, at the end of two weeks, and finally at the end of training.|Baseline, 2-week mark, 4-week mark|||ng/dL||Standard Deviation|Mean
654017|NCT01971723|Primary|Free Testosterone Outcomes|Measurements for free testosterone will occur on three occasions: prior to the start of supplementation and training, at the end of two weeks, and finally at the end of training.|Baseline, 2-week mark, 4-week mark|||ng/dL||Standard Deviation|Mean
654018|NCT01971723|Primary|Bio-availableTestosterone Outcomes|Measurements for total testosterone will occur on three occasions: prior to the start of supplementation and training, at the end of two weeks, and finally at the end of training.|Baseline, 2-week mark, 4-week mark|||ng/dL||Standard Deviation|Mean
654019|NCT01971723|Primary|Insulin-like Growth Factor-I Outcomes|Measurements for insulin-like growth factor-I will occur on three occasions: prior to the start of supplementation and training, at the end of two weeks, and finally at the end of training.|Baseline, 2-week mark, 4-week mark|||ng/dL||Standard Deviation|Mean
654020|NCT01971723|Primary|Estrogen Outcomes|Measurements for estrogen will occur on three occasions: prior to the start of supplementation and training, at the end of two weeks, and finally at the end of training.|Baseline, 2-week mark, 4-week mark|||pg/ml||Standard Deviation|Mean
654021|NCT01971723|Primary|Total Testosterone Outcomes|Measurements for testosterone will occur on three occasions: prior to the start of supplementation and training, at the end of two weeks, and finally at the end of training.|Baseline, 2-week mark, 4-week mark|||ng/dL||Standard Deviation|Mean
654022|NCT01971723|Primary|Blood Lipid Outcomes|Measurements for blood lipid panels will occur on three occasions: prior to the start of supplementation and training, at the end of two weeks, and finally at the end of training.|Baseline, 2-week mark, 4-week mark|||mg/dl||Standard Deviation|Mean
654023|NCT01971723|Primary|Insulin Outcomes|Measurements of insulin will occur on three occasions: prior to the start of supplementation and training, at the end of two weeks, and finally at the end of training.|Baseline, 2-week mark, 4-week mark|||ulU/ml||Standard Deviation|Mean
654024|NCT01971723|Primary|Strength Performance Outcomes|"Measurement of one repetition maximums strength for all competition lifts included in a standard, ungeared, powerlifting competition (squat, bench, and deadlift). This testing will take place before the supplementation of either T+ or placebo and at the end of the four-week training period.
Each measure was only compared within it's own category against the baseline measurement and against that of the other group at the same time point."|Baseline measures and 4 weeks from start of study|||Kg||Standard Deviation|Mean
654025|NCT01971554|Secondary|Change From Baseline in 24-Hour Weighted Mean Glucose (24h-WMG) at Day 15|"The 24h-WMG was considered to provide an integrated assessment of the glycemic exposure over the 24-hour period, and was derived from 18 blood samples collected immediately prior to, and after each meal, and overnight and fasting one hour pre-dose. A weighted rather than a simple mean is used to avoid overrepresentation of post-meal glucose values. On each day (Day -1 and Day 14), the WMG was computed as a time-weighted average of the 18 individual measurements."|Baseline and Day 15|The Per-Protocol population is the subset of participants who complied with the protocol sufficiently to ensure that these data are likely to exhibit the effects of treatment, according to the underlying scientific model. Data from 1 participant at Day 14 (Placebo group) was missing as the participant had to leave the study site.||mg/dL||Standard Error|Least Squares Mean
654026|NCT01971554|Secondary|Time to Reach Cmax (Tmax)|Tmax is a measure of the time to reach the maximum concentration in the plasma after the dose of study drug. Pharmacokinetic parameter analysis was not performed on the Placebo group.|Day 1: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, and 24 hours postdose; Day 14 : Predose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours postdose|The Per-Protocol population is the subset of participants who complied with the protocol sufficiently to ensure that these data are likely to exhibit the effects of treatment, according to the underlying scientific model. Pharmacokinetic testing was not performed on the Placebo group.||hr||Full Range|Median
654027|NCT01971554|Secondary|Maximum Plasma Drug Concentration After Dosing (Cmax)|Cmax is a measure of the maximum amount of drug in the plasma after the dose of study drug. Pharmacokinetic parameter analysis was not performed on the Placebo group. Method of dispersion for Cmax was geometric mean coefficient of variation percentage.|Day 1: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, and 24 hours postdose; Day 14 : Predose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours postdose|The Per-Protocol population is the subset of participants who complied with the protocol sufficiently to ensure that these data are likely to exhibit the effects of treatment, according to the underlying scientific model. Pharmacokinetic testing was not performed on the Placebo group.||μM||Geometric Coefficient of Variation|Geometric Mean
654028|NCT01971554|Secondary|Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC0-24h)|AUC0-last is a measure of the total amount of drug in the plasma from the dose to 24 hours after the dose of study drug. Pharmacokinetic parameter analysis was not performed on the Placebo group. Method of dispersion for AUC0-24h was geometric mean coefficient of variation percentage.|Day 1: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, and 24 hours postdose; Day 14 : Predose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours postdose|The Per-Protocol population is the subset of participants who complied with the protocol sufficiently to ensure that these data are likely to exhibit the effects of treatment, according to the underlying scientific model. Pharmacokinetic testing was not performed on the Placebo group.||μM·hr||Geometric Coefficient of Variation|Geometric Mean
654029|NCT01971554|Primary|Number of Participants Who Discontinued Study Drug Due to an AE|An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to 14 days|The Safety population consisted of all participants who received at least one dose of study medication.||Participants|||Number
654030|NCT01971554|Primary|Number of Participants Who Experienced at Least Once Adverse Event|An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to 28 days|The Safety population consisted of all participants who received at least one dose of study medication.||Participants|||Number
654031|NCT01971554|Primary|Change From Baseline in Fasting Plasma Glucose (FPG) at Day 15|Blood glucose was measured on a fasting basis (collected after an 8-hour fast). Blood was collected on Day -1 (pre-planned dose), predose on Days 1, 3, 7, and 14, and 24h postdose Day 14 (Day 15). The baseline measurement was computed as the average of the Day -1 and predose Day 1 measurements. FPG is expressed as mg/dL. This change from baseline reflects values for Day 15 FPG minus Day 0 FPG values.|Predose (Baseline) and 24 h postdose Day 14 (Day 15)|The Per-Protocol population is the subset of participants who complied with the protocol sufficiently to ensure that these data are likely to exhibit the effects of treatment, according to the underlying scientific model.||mg/dL||Standard Error|Least Squares Mean
654032|NCT01971385|Secondary|Number of Adverse Events Reported|To assess the safety and tolerability of squaric acid solution the number of adverse events in each treatment arm will be collected and compared.|8 months||||||
654033|NCT01971385|Primary|Subjects With at Least One Form of Contact With Study Staff With no Herpes Labialis Outbreaks Within 119 Days of Sensitization|Percent of subjects with no reported herpes labialis outbreak within 119 days of sensitization over total number of subjects after one form of contact with study staff|8 months|Because most patients who received 2% SADBE for sensitization did not experience another herpes outbreak and thus did not receive a subsequent treatment dose, we grouped both squaric acid treatment arms together for analysis since both groups had received the same sensitization dose of 2%.||percentage of particpants|||Number
654034|NCT01971255|Secondary|Number of Participants With Influenza Symptoms|This was determined by the presence or absence of influenza symptoms.|within 68 days after inoculation|The analysis included only those subjects who received the influenza challenge virus and was not found to have a confounding infection (i.e. other respiratory virus infection, urinary tract infection, etc.)||participants|||Number
654035|NCT01971255|Secondary|Number of Symptoms|A simple count of the number of unique influenza symptoms the participant experienced.|within 68 days after inoculation|The analysis included only those subjects who received the influenza challenge virus and was not found to have a confounding infection (i.e. other respiratory virus infection, urinary tract infection, etc.)||Number||Inter-Quartile Range|Median
654036|NCT01971255|Primary|Number of Patients With Mild to Moderate Influenza Disease (MMID)|This was determined by presence of the combination of symptoms of influenza and presence of a positive clinical test for influenza. If both were present then the participant had positive MMID.|Within 10 days of inoculation|The analysis included only those subjects who received the influenza challenge virus and were not found to have a confounding infection (i.e. other respiratory virus infection, urinary tract infection, etc.) In addition this represents the number of people who were high or low titer at the time of challenge with influenza virus not at screening.||participants|||Number
654037|NCT01971255|Secondary|Duration of Symptoms (Days)|The number of days a participant experienced any influenza symptoms|within 68 days after inoculation|The analysis included only those subjects who received the influenza challenge virus and was not found to have a confounding infection (i.e. other respiratory virus infection, urinary tract infection, etc.)||Days||Inter-Quartile Range|Median
654038|NCT01971255|Secondary|Duration of Shedding (Days)|The number of days total from the time a participant had the first positive test for influenza to their last positive test.|Within 14 days of inoculation|The analysis included only those subjects who received the influenza challenge virus and was not found to have a confounding infection (i.e. other respiratory virus infection, urinary tract infection, etc.)||Days||Inter-Quartile Range|Median
654039|NCT01971255|Secondary|Clinical Disease Severity Score|This was measured using a validated participant directed questionnaire called FLUPRO. This is then scored daily with a range of score from 0-185. The total score is the sum of all time points the questionnaire is given, which is 16 time points. Therefore the total score range is from 0-2960. 0 would represent no symptoms over the 16 time points while 2960 would represent maximum symptoms and perceived severity at all 16 time points.|Within 28 days after inoculation|The analysis included only those subjects who received the influenza challenge virus and was not found to have a confounding infection (i.e. other respiratory virus infection, urinary tract infection, etc.)||units on a scale||Inter-Quartile Range|Median
654044|NCT01971086|Secondary|The Single Score of Quality of Life Improvement at the Closing/Final Visit for Quality of Sleep|"The following quality of life improvement question at the final/closing visit were answered by the patients: How did Rhinospray plus improve the quality of your sleep? and How did Rhinospray Plus improve the quality of your sleep?."|Up to day 11|Patients from FAS||participants|||Number
654045|NCT01971086|Secondary|The Single Score of Quality of Life Improvement at the Closing/Final Visit for Daytime Activities|"The following quality of life improvement question at the final/closing visit were answered by the patients: How did Rhinospray plus improve the quality of your daytime activities?"|up to 11 days|Patients from FAS||participants|||Number
654046|NCT01971086|Secondary|The Change From Baseline in the Single Symptoms Scores ( Blocked Nose, Sneezing and Running Nose) at the Closing/Final Visit|Patients scored the single symptoms (blocked nose, sneezing and running nose) at the end of each treatment day on a 4-point rating scale with 0=absent, 1=mild, 2=moderate, 3=severe. The changes in the 3 single scores were calculated by the single score at the final visit minus the single score at baseline. Therefore, a negative change represents an improvement of the single scores.|Baseline and up to day 11|Patients from FAS.||units on a scale||Full Range|Median
654047|NCT01971086|Primary|The Mean of the 2 Single Quality of Life Improvement Scores at the Closing/Final Visit for Daytime Activities and Quality of Sleep|"The mean score of the following two quality of life improvement questions at the final/closing visit was calculated: How did Rhinospray plus improve the quality of your daytime activities? and How did Rhinospray Plus improve the quality of your sleep?. The scores range from 1=strongly to 4=no improvement. Thus also the range of the mean score is from 1 to 4."|up to day 11|Patients from FAS||units on a scale||Full Range|Median
654048|NCT01971086|Primary|The Change From Baseline in the Mean of the 3 Single Symptom Scores (Blocked Nose, Sneezing and Running Nose) at the Closing/Final Visit.|Patients scored the symptoms (blocked nose, sneezing and running nose) on a 4-point rating scale with 0=absent, 1=mild, 2=moderate, 3=severe. The range of the mean score thus could be between 0 and 3. The change in the mean of the 3 single scores was calculated by the score at the final visit minus the score at baseline. Therefore, a negative change represents an improvement of the mean score.|Baseline and up to day 11|Patients from the Full Analysis Set (FAS) which includes all patients in the TS who have analysable data in at least one efficacy endpoint.||units on a scale||Full Range|Median
654049|NCT01970995|Primary|Concentration of Total 4-(Methylnitrosamino)-1-(3- Pyridyl)-1-butanol) (Total NNAL)|"Concentrations measured at Day 90 in urine, adjusted for creatinine.
Geometric Least Squares (LS) means are provided as descriptive statistics."|90 days|The analysis was performed on the Per Protocol set (PP) which included all randomized subjects who had no major protocol deviation impacting the evaluability during the period Day 60 to Day 90.||pg/mg creat||95% Confidence Interval|Least Squares Mean
654050|NCT01970995|Primary|Levels of Carboxyhemoglobin (COHb)|"% COHb blood measurements performed in the evening of Day 5, expressed as % of saturation of hemoglobin.
Geometric Least Squares means are provided as descriptive statistics."|5 days|The analysis was performed on the Per Protocol set (PP) which included all randomized subjects who had no major protocol deviation impacting the evaluability during the confinement period.||% of saturation of hemoglobin||95% Confidence Interval|Least Squares Mean
654051|NCT01970995|Primary|Concentration of S-phenylmercapturic Acid (S-PMA)|"Concentrations measured at Day 5 in urine, adjusted for creatinine.
Geometric Least Squares (LS) means are provided as descriptive statistics."|5 days|The analysis was performed on the Per Protocol set (PP) which included all randomized subjects who had no major protocol deviation impacting the evaluability during the confinement period.||pg/mg creat||95% Confidence Interval|Least Squares Mean
654052|NCT01970995|Primary|Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA)|"Concentrations measured at Day 5 in urine, adjusted for creatinine.
Geometric Least Squares (LS) means are provided as descriptive statistics."|5 days|The analysis was performed on the Per Protocol set (PP) which included all randomized subjects who had no major protocol deviation impacting the evaluability during the confinement period.||ng/mg creat||95% Confidence Interval|Least Squares Mean
654053|NCT01970995|Primary|Concentration of Monohydroxybutenyl Mercapturic Acid (MHBMA)|"Concentrations measured at Day 5 in urine, adjusted for creatinine.
Geometric Least Squares (LS) means are provided as descriptive statistics."|5 days|The analysis was performed on the Per Protocol set (PP) which included all randomized subjects who had no major protocol deviation impacting the evaluability during the confinement period.||pg/mg creat||95% Confidence Interval|Least Squares Mean
654054|NCT01970982|Primary|Levels of Carboxyhemoglobin (COHb)|"% COHb blood measurements performed in the evening of Day 5, expressed as % of saturation of hemoglobin.
Geometric Least Squares means are provided as descriptive statistics."|5 days|"The analysis was performed on the full analysis set (FAS) population.
The FAS consisted of all the randomized subjects who had at least 1 post randomization product use experience (if randomized to THS 2.2 or CC) and had at least 1 valid BoExp measurement (THS 2.2, CC, SA arms)."||% of saturation of hemoglobin||95% Confidence Interval|Least Squares Mean
654055|NCT01970982|Primary|Concentration of S-phenylmercapturic Acid (S-PMA)|"Concentrations measured at Day 5 in urine, adjusted for creatinine.
Geometric Least Squares means are provided as descriptive statistics."|5 days|"The analysis was performed on the full analysis set (FAS) population.
The FAS consisted of all the randomized subjects who had at least 1 post randomization product use experience (if randomized to THS 2.2 or CC) and had at least 1 valid BoExp measurement (THS 2.2, CC, SA arms)."||pg/mg creat||95% Confidence Interval|Least Squares Mean
654056|NCT01970982|Primary|Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA)|"Concentrations measured at Day 5 in urine, adjusted for creatinine.
Geometric Least Squares means are provided as descriptive statistics."|5 days|"The analysis was performed on the full analysis set (FAS) population.
The FAS consisted of all the randomized subjects who had at least 1 post randomization product use experience (if randomized to THS 2.2 or CC) and had at least 1 valid BoExp measurement (THS 2.2, CC, SA arms)."||ng/mg creat||95% Confidence Interval|Least Squares Mean
654057|NCT01970982|Primary|Concentration of Monohydroxybutenyl Mercapturic Acid (MHBMA)|"Concentrations measured at Day 5 in urine, adjusted for creatinine.
Geometric Least Squares LS) means are provided as descriptive statistics."|5 days|"The analysis was performed on the full analysis set (FAS) population.
The FAS consisted of all the randomized subjects who had at least 1 post randomization product use experience (if randomized to THS 2.2 or CC) and had at least 1 valid biomarker of exposure (BoExp) measurement (THS 2.2, CC, SA arms)."||pg/mg creat||95% Confidence Interval|Least Squares Mean
654058|NCT01970878|Secondary|Change From Baseline in Average Daily Rescue Ventolin Use|Subjects recorded in their diary the number of puffs of rescue Ventolin HFA taken on each study day. The subject’s average daily number of puffs of rescue Ventolin HFA was calculated over the entire 52-week treatment period. Missing values were ignored in both the numerator and denominator. Diary data recorded during the last 7 days of the 10-14 day screening period were used to calculate the baseline average. Change in rescue Ventolin HFA use was calculated by subtracting the baseline average from the 52-week average.|Baseline through Week 52|Subjects in the ITT population from the lead-in studies who had data for the parameter||Puffs per day||95% Confidence Interval|Least Squares Mean
654059|NCT01970878|Secondary|Change From Baseline in SGRQ Total Score|The SGRQ is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of GFF MDI, FF MDI and GP MDI on health-related quality of life as compared to placebo in subjects with COPD. The scores range from 0 (best possible health status) to 100 (worst possible health status). The SGRQ contains 76 items grouped into three domains (symptoms, activity and impacts). Change from Baseline in total score of -4 units or lower is considered as clinically meaningful improvement in quality of life. SGRQ Total Score was assessed at multiple visits post-baseline, and a model-based average of all visits starting from Week 12 through week 52 inclusive was calculated. The change values reported in the table represent the change between the baseline and the average SGRQ Total Score post-baseline.|Baseline and Weeks 12 to 52|Subjects in the ITT population from the lead-in studies who had data for the parameter||Scores on a scale||95% Confidence Interval|Least Squares Mean
654060|NCT01970878|Secondary|Peak Change From Baseline in FEV1 Within 2 Hrs Post-dosing|Peak change from Baseline FEV1 Over 52 Weeks is a Model-Based Average (ITT Population). Peak FEV1 was assessed at multiple visits post-baseline, and a model-based average of all visits starting from Week 2 through week 52 inclusive was calculated. The change values reported in the table represent the change between the baseline and the average Peak FEV1 post-baseline.|Baseline and Weeks 2 to 52|Subjects in the ITT population from the lead-in studies who had data for the parameter.||Liters||95% Confidence Interval|Least Squares Mean
654061|NCT01970878|Secondary|Self-Administered Computerized (SAC) TDI Focal Score Over 52 Weeks|SAC TDI focal score over 52 Weeks as a Model-Based Average (ITT Population) The TDI is an instrument which measures the changes in the participant's dyspnea from Baseline. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI scores ranged from -3 (major deterioration) to +3 (major improvement); total score = -9 to 9.|Baseline and Weeks 4 to 52|Subjects in the ITT population from the lead-in studies who had data for the parameter.||Scores on a scale||95% Confidence Interval|Least Squares Mean
654062|NCT01970878|Primary|Change From Baseline in Morning -Pre-dose Trough FEV1 Over 52 Weeks|Change From Baseline in Morning Pre-Dose Trough FEV1 Over 52 Weeks as a Model-Based Average (ITT Population). FEV1 was assessed at multiple time points post-baseline, and a model-based average of all visits starting from Week 2 through week 52 inclusive was calculated. The change values reported in the table represent the change between the baseline and the average FEV1 post-baseline.|Baseline and Weeks 2 to 52|Subjects in the ITT population from the lead-in studies who had data for the parameter.||Liters||95% Confidence Interval|Least Squares Mean
654063|NCT01970787|Secondary|Progression of HSIL to Cancer|Histologic progression of HSIL to cancer as measured in biopsies read at the central pathology lab. Data not collected and could not be analyzed.|12 months||||||
654064|NCT01970787|Secondary|Adverse Events|Any related adverse event occuring in patients enrolled in this study. Event type and relationship to the device or procedure will be measured.|12 months|||participants|||Number
654065|NCT01970787|Secondary|Tolerability|"Subject tolerability of the RFA procedure as measured by severity. Mild: Awareness of signs and symptoms, but easily tolerated; are of a minor irritant type; causing no loss of time from normal activities; symptoms would not require medication or a medical intervention; asymptomatic lab findings; marginal clinical relevance; signs and symptoms are transient.
Moderate: Discomfort severe enough to cause interference with usual activities; minimal intervention.
Severe: Incapacitating with inability to do work or usual activities; signs and symptoms may be of systemic nature or require medical evaluation or treatment."|12 months|||participants|||Number
654066|NCT01970787|Secondary|Feasibility and Ease of Technique|"Technical feasibility of applying RFA to the anal canal. Physician's assessment of ablation as optimal (complete ablation) versus sub-optimal (incomplete ablation)in the affected area in the anal canal.
Data not collected and could not be analyzed"|12 months||||||
654067|NCT01970787|Primary|Clearance of Anal HSIL (High Grade Squamous Intraepithelial Lesion (HSIL)|Participants with histologic clearance of anal HSIL within the ETZ (eligible treatment zone) at 12 months from first RFA treatment|12 months|||participants w histological clearance|||Number
654068|NCT01970488|Post-Hoc|Percentage of Participants With a PASI 100 Response at Week 50|A PASI 100 response is a 100% improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.|Baseline and Week 50|This analysis was performed in the re-randomized analysis set with available data.||percentage of participants|||Number
654069|NCT01970488|Post-Hoc|Percentage of Participants With a PASI 100 Response at Week 32|A PASI 100 response is a 100% improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.|Baseline and Week 32|This analysis was performed in the re-randomized analysis set with available data||percentage of participants|||Number
654079|NCT01970488|Secondary|Percentage of Participants With a sPGA Response at Week 50|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).|Week 50|This analysis was performed in the re-randomized analysis set with available data.||percentage of participants|||Number
655309|NCT01952665|Primary|Average Daily Wearing Time|Participants measure of average daily wear time for study lenses at 4 weeks.|4 weeks|||hours||Standard Deviation|Mean
654070|NCT01970488|Post-Hoc|Percentage of Participants With a PASI 100 Response at Week 16|A PASI 100 response is a 100% improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.|Baseline and Week 16|Full analysis set; LOCF imputation was used for participants with at least 1 postbaseline value.||percentage of participants|||Number
654071|NCT01970488|Post-Hoc|Percentage of Participants With a PASI 90 Response at Week 50|"A PASI 90 response is a 90% or greater improvement (reduction) from baseline in PASI score.
The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis."|Baseline and Week 50|This analysis was performed in the re-randomized analysis set with available data.||percentage of participants|||Number
654072|NCT01970488|Post-Hoc|Percentage of Participants With a PASI 90 Response at Week 32|"A PASI 90 response is a 90% or greater improvement (reduction) from baseline in PASI score.
The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis."|Baseline and Week 32|This analysis was performed in the re-randomized analysis set with available data||percentage of participants|||Number
654073|NCT01970488|Post-Hoc|Percentage of Participants With a PASI 90 Response at Week 16|A PASI 90 response is a 90% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.|Baseline and Week 16|Full analysis set; LOCF imputation was used for participants with at least 1 postbaseline value.||percentage of participants|||Number
654074|NCT01970488|Secondary|Percentage of Participants Developing Antibodies to ABP 501 or Adalimumab|"Two validated assays were used to detect the presence of anti-drug antibodies. Samples were first tested in an electrochemiluminescence (ECL)-based bridging immunoassay to detect anti-drug antibodies (ADA) against ABP 501 and adalimumab (Binding Antibody Assay). Samples confirmed to be positive for binding antibodies were subsequently tested in a non-cell based bioassay to determine neutralizing activity against ABP 501 or adalimumab (Neutralizing Antibody Assay).
Developing antibody incidence is defined as a negative or no antibody result at baseline and a positive antibody result at a post-baseline time point."|For 16 weeks in Part 1 and for 52 weeks for participants who were re-randomized in Part 2.|Results are reported for the anti-drug antibody analysis set (defined as the subset of participants in the Safety Analysis Set who had at least 1 evaluable antibody test) from Baseline to Week 16 for all randomized participants, and from baseline to Week 52 for participants who were re-randomized.||percentage of participants|||Number
654075|NCT01970488|Secondary|Number of Participants With Adverse Events|"The Investigator assessed whether each adverse event (AE) was possibly related to the investigational product. AEs were graded for severity according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.03.
A serious AE is defined as an AE that meets at least 1 of the following serious criteria:
fatal
life threatening
requires inpatient hospitalization or prolongation of existing hospitalization
results in persistent or significant disability/incapacity
congenital anomaly/birth defect
other medically important serious event. Results are reported from Day 1 to week 16 for the Part 1 ABP 501 and Adalimumab groups, and from post week 16 to the end of study (week 52) for the Part 2 ABP 501/ABP 501, Adalimumab/Adalimumab and Adalimumab/ABP 501 groups."|From first dose of study drug until 28 days after the last dose. Treatment was for 16 weeks in Part 1 and 32 weeks in Part 2.|The safety analysis set includes all randomized participants who received at least 1 dose of study drug, based on actual treatment received.||participants|||Number
654076|NCT01970488|Secondary|Change From Baseline in the Percentage of BSA Involved With Psoriasis at Week 50|"A measurement of psoriasis involvement, given as the physician’s assessment of the percentage of the participant’s total body surface area (BSA) involved with psoriasis. The percent of BSA affected was estimated by assuming that the subject’s palm, excluding the fingers and thumb, represented roughly 1% of the body’s surface.
Change from baseline is calculated as (value at post-baseline visit - value at baseline).
A decrease from Baseline (negative value) indicates improvement."|Baseline and week 50|This analysis was performed in the re-randomized analysis set with available data||percentage of BSA||Standard Deviation|Mean
654077|NCT01970488|Secondary|Change From Baseline in the Percentage of BSA Involved With Psoriasis at Week 32|"A measurement of psoriasis involvement, given as the physician’s assessment of the percentage of the participant’s total body surface area (BSA) involved with psoriasis. The percent of BSA affected was estimated by assuming that the subject’s palm, excluding the fingers and thumb, represented roughly 1% of the body’s surface.
Change from baseline is calculated as (value at post-baseline visit - value at baseline).
A decrease from Baseline (negative value) indicates improvement."|Baseline and week 32|This analysis was performed in the re-randomized analysis set with available data||percentage of BSA||Standard Deviation|Mean
654078|NCT01970488|Secondary|Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis at Week 16|"A measurement of psoriasis involvement, given as the physician’s assessment of the percentage of the participant’s total body surface area (BSA) involved with psoriasis. The percent of BSA affected was estimated by assuming that the subject’s palm, excluding the fingers and thumb, represented roughly 1% of the body’s surface.
Change from baseline is calculated as (value at post-baseline visit - value at baseline).
A decrease from baseline (negative value) indicates improvement."|Baseline and Week 16|Full analysis set; LOCF imputation was used for participants with at least 1 postbaseline value.||percentage of BSA||Standard Deviation|Mean
654102|NCT01969799|Secondary|Number of Days Free of Mechanical Ventilation From Day 1 Through Day 28|Number of days free of mechanical ventilation from Day 1 through Day 28 mean days.|Day 1 - Day 28|MITT||Days ± SD||Standard Deviation|Mean
654080|NCT01970488|Secondary|Percentage of Participants With a sPGA Response at Week 32|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).|Week 32|This analysis was performed in the re-randomized analysis set with available data||percentage of participants|||Number
654081|NCT01970488|Secondary|Percentage of Participants With a Static Physician’s Global Assessment (sPGA) Response at Week 16|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).|Week 16|Full analysis set; LOCF imputation was used for participants with at least 1 postbaseline value.||percentage of participants|||Number
654082|NCT01970488|Secondary|Percent Improvement From Baseline in PASI at Week 50|"The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.
Percent improvement from baseline is calculated as (value at baseline – value at post-baseline visit) × 100 / (value at baseline)."|Baseline and week 50|This analysis was performed in the re-randomized analysis set with available data||percent change||Standard Deviation|Mean
654083|NCT01970488|Secondary|Percent Improvement From Baseline in PASI at Week 32|"The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.
Percent improvement from baseline is calculated as (value at baseline – value at post-baseline visit) × 100 / (value at baseline)."|Baseline and week 32|This analysis was performed in the re-randomized analysis set with available data||percent change||Standard Deviation|Mean
654084|NCT01970488|Secondary|Percentage of Participants With a PASI 75 Response at Week 50|"A PASI 75 response is a 75% or greater improvement (reduction) from baseline in PASI score.
The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis."|Baseline and week 50|This analysis was performed in the re-randomized analysis set which includes all participants who were re-randomized at Week 16 in the study. Only participants with available data at week 50 are included.||percentage of participants|||Number
654085|NCT01970488|Secondary|Percentage of Participants With a PASI 75 Response at Week 32|"A PASI 75 response is a 75% or greater improvement (reduction) from baseline in PASI score.
The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis."|Baseline and week 32|This analysis was performed in the re-randomized analysis set which includes all participants who were re-randomized at Week 16 in the study. Only participants with available data at week 32 are included.||percentage of participants|||Number
654086|NCT01970488|Secondary|Percentage of Participants With a PASI 75 Response at Week 16|A PASI 75 response is a 75% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.|Baseline and Week 16|Full analysis set; LOCF imputation was used for participants with at least 1 postbaseline value.||percentage of participants|||Number
654087|NCT01970488|Primary|Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) at Week 16|"The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.
Percent improvement from baseline was calculated as (value at baseline – value at post-baseline visit) × 100 / (value at baseline)."|Baseline and Week 16|This analysis was performed using the full analysis set which includes all participants initially randomized in the study. Last observation carried forward (LOCF) imputation was used for participants with at least one post-baseline value.||percent change||Standard Deviation|Mean
654088|NCT01970475|Secondary|Percentage of Participants Who Developed Antibodies to ABP 501 or Adalimumab|"Two validated assays were used to detect the presence of anti-drug antibodies. Samples were first tested in an electrochemiluminescence (ECL)-based bridging immunoassay to detect anti-drug antibodies (ADA) against ABP 501 and adalimumab (Binding Antibody Assay). Samples confirmed to be positive for binding antibodies were subsequently tested in a non-cell based bioassay to determine neutralizing activity against ABP 501 or adalimumab (Neutralizing Antibody Assay).
Developing antibody incidence is defined as a negative or no antibody result at baseline and a positive antibody result at a post-baseline time point."|Up to week 26|Participants with at least 1 evaluable antibody test result (to either ABP 501 or adalimumab)||percentage of participants|||Number
654089|NCT01970475|Secondary|Number of Participants With Adverse Events|"Adverse events (AEs) were graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 according to the following scale:
1 = mild; 2 = moderate; 3 = severe; 4 = life-threatening; 5 = fatal. A treatment-related AE is defined as an event where the answer to the question “is there a reasonable possibility that the event may have been caused by the Investigational Medicinal Product” was yes.
A serious adverse event is defined as an AE that meets at least 1 of the following serious criteria:
fatal
life threatening (places the subject at immediate risk of death)
requires inpatient hospitalization or prolongation of existing hospitalization
results in persistent or significant disability/incapacity
congenital anomaly/birth defect
other medically important serious event."|From the time of first treatment up to 28 days following the last dose of study treatment; 26 weeks.|The safety analysis set (all participants who received at least 1 dose of study drug)||participants|||Number
654090|NCT01970475|Secondary|Percentage of Participants With an ACR70 Response at Week 24|"A participant was a responder if the following 3 criteria for improvement from Baseline were met:
≥ 70% improvement in tender joint count;
≥ 70% improvement in swollen joint count; and
≥ 70% improvement in at least 3 of the 5 following parameters:
Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
Patient's global assessment of disease activity (measured on a likert scale from 0 to 10);
Physician's global assessment of disease activity (measured on a likert scale from 0 to 10);
Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);
C-Reactive Protein level."|Baseline and Week 24|Full analysis set with available data at week 24||percentage of participants|||Number
654091|NCT01970475|Secondary|Percentage of Participants With an ACR50 Response at Week 24|"A participant was a responder if the following 3 criteria for improvement from Baseline were met:
≥ 50% improvement in tender joint count;
≥ 50% improvement in swollen joint count; and
≥ 50% improvement in at least 3 of the 5 following parameters:
Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
Patient's global assessment of disease activity (measured on a likert scale from 0 to 10);
Physician's global assessment of disease activity (measured on a likert scale from 0 to 10);
Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);
C-Reactive Protein level."|Baseline and week 24|Full analysis set with available data at week 24||percentage of participants|||Number
654092|NCT01970475|Secondary|Percentage of Participants With an ACR20 Response at Week 2 and Week 8|"A participant was a responder if the following 3 criteria for improvement from Baseline were met:
≥ 20% improvement in tender joint count;
≥ 20% improvement in swollen joint count; and
≥ 20% improvement in at least 3 of the 5 following parameters:
Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
Patient's global assessment of disease activity (measured on a likert scale from 0 to 10);
Physician's global assessment of disease activity (measured on a likert scale from 0 to 10);
Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);
C-Reactive Protein level."|Baseline, week 2 and week 8|Full analysis set; LOCF imputation was used for participants with at least 1 postbaseline value (indicated by n).||percentage of participants|||Number
654093|NCT01970475|Secondary|Change From Baseline in Disease Activity Score 28-C-reactive Protein (DAS28-CRP)|"The DAS28-CRP is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables:
The number of swollen and tender joints assessed using the 28-joint count;
C-reactive protein (CRP) level
Patient's global assessment of disease activity assessed on a score from 0 to 100 transformed from the result measured on a horizontal scale from 0 (no RA activity at all) to 10 (worst RA activity imaginable).
The DAS28-CRP score ranges from approximately zero to ten. Higher DAS28-CRP scores indicate higher disease activity.
A repeated measures analysis with the DAS28-CRP change from baseline as the response and the stratification variables, visit, treatment, treatment-by-visit interaction and the baseline DAS28-CRP measurement as predictors in the model was performed."|Baseline and weeks 2, 4, 8, 12, 18, and 24|Full analysis set with available data at each time point||units on a scale||Standard Deviation|Least Squares Mean
654094|NCT01970475|Primary|Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Week 24|"A participant was a responder if the following 3 criteria for improvement from Baseline were met:
≥ 20% improvement in tender joint count;
≥ 20% improvement in swollen joint count; and
≥ 20% improvement in at least 3 of the 5 following parameters:
Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
Patient's global assessment of disease activity (measured on a likert scale from 0 to 10);
Physician's global assessment of disease activity (measured on a likert scale from 0 to 10);
Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);
C-Reactive Protein level."|Baseline and Week 24|The full analysis set (all randomized participants); missing values were imputed using the last observation carried forward (LOCF) method for participants with at least 1 postbaseline value.||percentage of participants|||Number
654095|NCT01970397|Secondary|Subject's Global Assessment of Change in Appearance of Perioral Lines|The participant evaluated the change in the appearance of their perioral lines (the lines that radiate outward from the edges of the upper and lower lips) using a 7-point scale where: 1 = Very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; 7=Very much worse.|Baseline, Days 7, 14, Days 7, 14 after touch-up, Months 1, 3 and 6|Participants from the Intent-to-treat population, all randomized treated participants, with data available at the given time-point.||units on a scale||95% Confidence Interval|Mean
654096|NCT01970397|Secondary|Participant Assessed Procedural and Post-Procedural Pain Levels|The participant assessed procedural and post-procedural pain using an 11-point scale where: 0=no pain to 10=worst pain imaginable.|During injection, immediately following injection, 15, 30, and 45 min post-injection|Intent-to-treat population included all randomized and treated participants.||units on a scale||95% Confidence Interval|Mean
654097|NCT01970397|Primary|Percentage of Participants With at Least a 1 Point Improvement From Baseline on the Perioral Lines Severity Scale (POLSS)|The investigator evaluated the severity of the participant’s upper and low lip at Baseline (Pre-treatment) to Month 6 using the 4-point POLSS where None=No lines, Mild=Few, shallow lines, Moderate=Some, moderate lines or Severe=Many, deep lines or crevices. The percentage of participants with at least a 1 Point Improvement is reported.|Baseline, Month 6|Participants from the Intent-to-treat population, all randomized treated participants, with data available for analysis at Month 6.||percentage of participants|||Number
654098|NCT01969799|Secondary|Clinical Relapse Rate|Clinical relapse rates (defined as a new episode of pneumonia requiring reinstitution of IV antibiotics) from Day 11 through Day 28|Day 11 - Day 28|MITT||participants|||Number
654099|NCT01969799|Secondary|Mortality From Day 1 Through Day 28|Mortality from Day 1 through Day 28, all causes, does not reflect just infection only|Day 1 - Day 28|MITT||participants|||Number
654100|NCT01969799|Secondary|Microbiological Response Rates in Patients Positive for Multi-drug Resistant Gram-negative Bacteria|Microbiological response rates at Day 14 in patients whose pre-study treatment bronchoalveolar lavage (BAL) was positive for multi-drug resistant Gram-negative bacteria. Response is defined as not have a positive tracheal aspirate culture on Day 14|Day 14|patients with MDR bacteria at baseline BAL||Participants|||Count of Participants
654101|NCT01969799|Secondary|Number of ICU Days From Day 1 Through Day 28||Day 1 - Day 28|MITT||Days||Standard Deviation|Mean
673113|NCT01664975|Secondary|Response Rate|21 days(3 weeks) for one cycle,Efficacy was evaluated every two cycles|every 6 weeks,up to completion of treatment(approximately 18 weeks )||09/2016||||
654104|NCT01969799|Secondary|Composite Endpoint of Mortality and Clinical Cure|The hierarchical composite endpoint of mortality, then clinical cure (defined as both absence of Gram-negative bacteria and CPIS at Day 14 < 6). The tables reflect a winner of matched pairs, ties are not noted.|Day 1 - Day 28|MITT||participants|||Number
654105|NCT01969799|Primary|Change From Baseline in Clinical Pulmonary Infection Score (CPIS) For Each Patient, Value Obtained From a Daily Assessment Over the 10 Day Study Period Was Compared to Baseline, and the LSM Data Represent the Change From Baseline Data Over All Days .|Change from baseline in Clinical Pulmonary Infection Score (CPIS) For each patient, value obtained from a daily assessment over the 10 day study period was compared to baseline, and the LSM data represent the change from baseline data over all days. Daily CPIS will be determined by one blinded, central reviewer in order to minimize inter-observer variability. The scale ranges from 0 to 13, with 13 being the worst. The value of zero would be a healthy patient with no evidence of pneumonia. For each patient, there was a daily assessment for the 10 day study period.|10 day treatment period.|MITT||units on a scale||Standard Error|Least Squares Mean
654106|NCT01969747|Primary|Change From Baseline in 24 h UGE (g/24 h) After Seven Days of Treatment With Empagliflozin 2.5 mg, 10 mg, or 25 mg, or Placebo|"Change of urinary glucose excretion (UGE) (g/24 h) from baseline (refers to the last measurement prior to the first intake of any randomised trial medication) after seven days of treatment with empagliflozin 2.5 mg, 10 mg, or 25 mg, or placebo.
The treatment effect was estimated on the basis of the least square mean treatment difference at Day 7 extracted from the primary analysis model.
The primary endpoint is exploratory."|baseline (Day -1) and 7 days after first drug administration (Day 7)|"Full analysis set (FAS): all patients randomised, treated with at least one dose of study drug, had a baseline UGE (g/24 h) and a UGE (g/24 h) on Day 1 or Day 7.
The last observation carried forward (LOCF) approach was used as the primary method of imputation for missing data."||g/24h||Standard Error|Mean
654107|NCT01969721|Secondary|FEV1 Peak (0−3h) Change From Patient Baseline After 6 Weeks of Treatment|Change from patient baseline in Forced Expiratory Volume in one second (FEV1) peak (0-3 hours) after 6 weeks of treatment. FEV1 peak (0-3 hours) was defined as the maximum FEV1 value measured within the first three hours post dosing. Measured values presented are actually adjusted means.|Baseline and 6 weeks.|FAS (Full Analysis Set): Included all randomised patients who were documented to have had received any dose of trial medication and who had both baseline and any evaluable post-baseline measurement for the primary efficacy endpoint.||Litres||Standard Error|Mean
654108|NCT01969721|Secondary|FEV1 AUC (12−24h) Change From Patient Baseline After 6 Weeks of Treatment|"Change from patient baseline in Forced Expiratory Volume in one second (FEV1) Area Under the FEV1-time Curve from 12 to 24 hours post-dose (AUC 12-24h) [L] after 6 weeks of treatment. Measured values presented are actually adjusted means.
The period baseline is defined as the pre-dose measurement taken at on the day 1 of each period. The patient baseline is defined as the mean of non-missing period baselines for each patient."|Baseline and 6 weeks.|FAS (Full Analysis Set): Included all randomised patients who were documented to have had received any dose of trial medication and who had both baseline and any evaluable post-baseline measurement for the primary efficacy endpoint.||Litres||Standard Error|Mean
654109|NCT01969721|Secondary|Trough FEV1 Change From Patient Baseline After 6 Weeks of Treatment|"Change from patient baseline in Trough Forced Expiratory Volume in one second (FEV1) after 6 weeks of treatment. Trough FEV1 was defined as the mean of the 23h and 23h 50min (minutes) post-dose FEV1 measurements. Measured values presented are actually adjusted means.
The period baseline is defined as the pre-dose measurement taken at on the day 1 of each period. The patient baseline is defined as the mean of non-missing period baselines for each patient."|Baseline and 6 weeks.|FAS (Full Analysis Set): Included all randomised patients who were documented to have had received any dose of trial medication and who had both baseline and any evaluable post-baseline measurement for the primary efficacy endpoint.||Litres||Standard Error|Mean
654110|NCT01969721|Secondary|FEV1 AUC (0−24h) Change From Patient Baseline After 6 Weeks of Treatment|"Change from patient baseline in Forced Expiratory Volume in one second (FEV1) Area Under the FEV1-time Curve from 0 to 24 hours post-dose (AUC 0-24h) [L] after 6 weeks of treatment.
Measured values presented are actually adjusted means. The period baseline is defined as the pre-dose measurement taken at on the day 1 of each period. The patient baseline is defined as the mean of non-missing period baselines for each patient."|Baseline and 6 weeks.|FAS (Full Analysis Set): Included all randomised patients who were documented to have had received any dose of trial medication and who had both baseline and any evaluable post-baseline measurement for the primary efficacy endpoint.||Litres||Standard Error|Mean
654111|NCT01969721|Primary|FEV1 AUC (0−12h) Change From Patient Baseline After 6 Weeks of Treatment|"Change from patient baseline in Forced Expiratory Volume in one second (FEV1) Area Under the FEV1-time Curve from 0 to 12hours post-dose (AUC 0-12h) [L] after 6 weeks of treatment. Measured values presented are actually adjusted means.
The period baseline is defined as the pre-dose measurement taken at on the day 1 of each period. The patient baseline is defined as the mean of non-missing period baselines for each patient."|Baseline and 6 weeks.|FAS (Full Analysis Set): Included all randomised patients who were documented to have had received any dose of trial medication and who had both baseline and any evaluable post-baseline measurement for the primary efficacy endpoint.||Litres||Standard Error|Mean
654112|NCT01969565|Secondary|Overall Response Rate (ORR), Defined as sCR, CR, Very Good Partial Response (VGPR), and PR at 4 Cycles||4 months||||||
654113|NCT01969565|Primary|Phase 2: Patients With >= VGPR (Very Good Partial Response)|The overall response rate will be estimated based on the crude proportion of subjects for whom best overall response is stringent complete response (sCR), complete response (CR), VGPR, and partial response (PR).|4 months-8months||||||
654114|NCT01969565|Primary|Tolerability and Safety of Increasing Doses of Carfilzomib in Combination With Dexamethasone.|"Adverse events will be coded according to the Medical Dictionary for Regulatory Activities (MedDRA) adverse event dictionary. The results will be tabulated to examine their frequency, organ systems affected, and relationship to study treatment. The results of laboratory assessments will be evaluated similarly.
The study is designed to evaluate the efficacy and safety of carfilzomib in combination with dexamethasone. Carfilzomib will be administered at a dose of 20 mg/m2, with a dose escalation to 36 mg/m2 after Days 1 and 2 of Cycle 1 in level 1; and at a dose of 20 mg/m2, with a dose escalation to 45 mg/m2 after Days 1 and 2 of Cycle 1 in level 2 in subjects with multiple myeloma who are newly diagnosed and treatment naïve. Dexamethasone will be given as a fixed dose of 20 mg PO/IV (1, 2, 8, 9, 15, 16, 22, and 23) for cycles 1 to 4 and for subsequent cycles."|24 months|Patient withdrew consent before receiving treatment|||||
654115|NCT01969539|Primary|Pre-dose Subtracted Maximum Measured Concentration of Albuterol|"Pre-dose subtracted maximum measured concentration (Cmax) of albuterol.
Standard pharmacokinetic (PK) analyses were not conducted due to a carry-over effect. As a consequence, the pre-specified primary endpoint (maximum measured concentration of ipratropium and albuterol) was not reported. The predose subtracted Cmax was calculated instead of the primary endpoint."|Pre-treatment and 5 minutes (min), 15min, 30min, 60min, 2 hours (h), 4h, 6h after each inhalation of study medication|Treated set||ng/ml||Standard Deviation|Mean
654116|NCT01969539|Secondary|Area Under the Concentration-time Curve Over the Time Interval From 0 to 6 Hour (AUC 0-6) of Ipratropium and Albuterol|"Area under the concentration-time curve over the time interval from 0 to 6 hour (AUC 0-6) of ipratropium and albuterol.
This secondary endpoint was not calculated due to a carry-over effect."|Pre-treatment and 5 minutes (min), 15min, 30min, 60min, 2 hours (h), 4h, 6h after each inhalation of study medication|Treated set|||||
654117|NCT01969539|Primary|Pre-dose Subtracted Maximum Measured Concentration of Ipratropium|"Pre-dose subtracted maximum measured concentration (Cmax) of ipratropium.
Standard pharmacokinetic (PK) analyses were not conducted due to a carry-over effect. As a consequence, the pre-specified primary endpoint (maximum measured concentration of ipratropium and albuterol) was not reported. The predose subtracted Cmax was calculated instead of the primary endpoint."|Pre-treatment and 5 minutes (min), 15min, 30min, 60min, 2 hours (h), 4h, 6h after each inhalation of study medication|Treated set||pg/ml||Standard Deviation|Mean
654118|NCT01969435|Post-Hoc|Overall Survival (OS) Rate||Median follow-up 15.4 months (range 4.7-24.6)|||percentage of participants|||Number
654119|NCT01969435|Post-Hoc|Relapse Free Survival||1 year|||percentage of participants|||Number
654120|NCT01969435|Post-Hoc|Progression-free Survival Rate (PFS)||1 year|||percentage of participants||95% Confidence Interval|Median
654121|NCT01969435|Post-Hoc|Progression-free Survival (PFS) Rate|PFS - Time from start of treatment to the time of progression or death, whichever occurs first.|6 months|||percentage of participants||95% Confidence Interval|Median
654122|NCT01969435|Secondary|Time to Engraftment (Platelet)|Time from the date of transplant to the date of platelet engraftment.|Assessed up to day 100|One patient did not have platelet engraftment by Day 100||days||Full Range|Median
654123|NCT01969435|Secondary|Time to Engraftment (Neutrophil)|Time from the date of the transplant to the date of neutrophil engraftment.|Assessed up to day 30|||days||Full Range|Median
654124|NCT01969435|Secondary|Disease-free Survival|For patients with CR at day +100. Proportion of patients who survive without any signs or symptoms of cancer at 2 years.|2 years||05/2018||||
654125|NCT01969435|Secondary|Disease-free Survival|Percentage of patients who survive without any signs or symptoms of cancer at 1 year.|1 year|||percentage of participants||95% Confidence Interval|Number
654126|NCT01969435|Secondary|Efficacy as Measured by Response Rates|"The response rates according to each category of response Complete Response (CR), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD) will be summarized by the proportion of patients meeting each criterion.
Evaluated using PET or CT scan and Revised Response Criteria for Malignant Lymphoma"|Up to Day 100|||percentage of participants|||Number
654127|NCT01969435|Primary|Treatment-related Mortality (TRM)|TRM is defined as death not due to progressive lymphoma prior to Day 100 after transplant|100 days|||percentage of participants|||Number
654128|NCT01969435|Primary|Safety and Toxicity as Measured by Treatment Related Non-hematologic Adverse Events|Adverse events will be assessed using the National Cancer Institute (NCI)-CTCAE version 4.0. Number of events, grade 2 or higher, occurring in 10% or greater of participants. Grade 2 diarrhea and Grade 2 nausea/vomiting were not recorded.|Day -7 through Day 30|||participants|||Number
654129|NCT01969162|Primary|Tear Lipid Composition Profile|Basal (non-stimulated) tear samples were collected from one eye for lipid analysis. 13 different lipids classes were detected in individual tear samples. The concentration of each lipid class is reported in picomoles (pmole).|Day 1|A subset of enrolled participants who had non-stimulated (basal) tear samples.||pmole||Standard Deviation|Mean
654130|NCT01969084|Secondary|Changes in Circulating Endothelial Progenitor Cell Phenotypes|The measurements of the various EPC phenotypes were performed at the Beth Israel Deaconess Flow Cytometry Core Facility. Immunofluorescent cell staining was performed on peripheral blood with the use of the fluorescent conjugated antibodies. 1.000.000 events per sample were acquired using a FACS LSR II analyzer (Becton Dickinson, Franklin Lakes, NJ, USA) and the results were analyzed using the Beckman Coulter Kaluza analysis software (Beckman Coulter Inc., Brea, CA, USA).|Baseline and 12 weeks|||Events per million||Inter-Quartile Range|Median
654131|NCT01969084|Secondary|Changes in SDF1-α and Substance P||Baseline and 12 weeks|||pg/ml||Inter-Quartile Range|Median
654132|NCT01969084|Secondary|Changes in Vascular Reactivity in the Micro- and Macro-circulation.|Change in markers of macro- and microvascular function from the baseline visit to the post-treatment visit between the two groups.|Baseline and 12 weeks|||percent change||Inter-Quartile Range|Median
654133|NCT01969084|Secondary|Change in Muscle Oxygenation Recovery Time|Change in muscle oxygenation after ischemia inducing occlusion for 4 minutes.|Baseline and 12 weeks|||seconds||Inter-Quartile Range|Median
654134|NCT01969084|Primary|Phosphocreatine (PCR) Recovery Time After Exhaustive or up to 6 Minutes of Leg Exercise.|Change in the time to phosphocreatine recovery between the baseline visit and post-treatment visit following the graded exercise test.|Baseline and 12 weeks|||seconds||Inter-Quartile Range|Median
654135|NCT01969058|Secondary|Primary Targeted Adverse Events|Targeted events for A5325 include: events that meet the International Conference on Harmonization (ICH) definitions for a serious adverse event, post-entry signs/symptoms and laboratory abnormalities of Grade ≥3 or that lead to a change in treatment regardless of grade, and any diagnoses.|from study entry to end of study (week 28)|all enrolled participants||Participants|||Count of Participants
654143|NCT01969058|Secondary|Change in sCD163|"sCD163 (soluble CD 163) is a marker of macrophage activation Change in log10 transformed sCD163 from baseline to week 14/16 (week 14/16 - baseline), from week 14/16 to week 28 (week 28 - week 14/16), and from baseline to week 28 (week 28 - baseline).
Levels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16."|baseline, week 14/16, week 28|"The analysis is complete case as-treated, and is limited to participants who:
have data for both baseline and week 14/16
(for the Isotretinoin arm) completed treatment (allowing ≤8 missed doses)
did not use prohibited medications
did not experience virologic failure from baseline to week 16"||log10 ng/mL||Inter-Quartile Range|Median
654136|NCT01969058|Secondary|Pharmacokinetics – Trough Concentrations of Isotretinoin and Antiviral Treatment (ART)|"Isotretinoin arm only, trough concentrations of isotretinoin at weeks 8, 12, 16, and trough concentrations of ART at study entry and weeks 8, 12, 16, 20 and 24.
Pharmacokinetics data are not available as of August 2017. To minimize variability, pharmacokinetics assays were batched. Due to batching, sample shipment could not begin until after the study follow-up completion, which was 3 months after the primary completion date. Given that this was a multi-center study, shipment of samples took several months to complete. Therefore, samples are in the process of being tested. Upon completion of the testing, the results will be reviewed for data completeness and quality. After resolution of any issues and finalization of the database, the analysis can be conducted and the results will then be posted to ClinicalTrials.gov. We expect to complete analysis and post results to ClinicalTrials.gov by December 2017."|study entry, weeks 8, 12, 16, 20 and 24||12/2017||||
654137|NCT01969058|Secondary|Change in Endogenous Retinoid Metabolite Profiles|"Change in endogenous retinoid metabolite profiles from baseline to week 14/16 (week 14/16 - baseline), from week 14/16 to week 28 (week 28 - week 14/16), and from baseline to week 28 (week 28 - baseline).
Levels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16.
Data for endogenous retinoid metabolite profiles is not available as of August 2017. Pharmacokinetics assays were batched to minimize variability. Sample shipment could not begin until after the study follow-up completion, which was 3 months after the primary completion date. Given that this was a multi-center study, shipment of samples took several months to complete. Upon completion of the testing, the results will be reviewed for data completeness and quality. We expect to complete analysis and post results to ClinicalTrials.gov by December 2017."|baseline, week 14/16, week 28||12/2017||||
654138|NCT01969058|Secondary|Change in Cell-associated HIV-1 RNA|"Change in genomic HIV-1 RNA in blood from baseline to week 14/16(week 14/16 - baseline), from week 14/16 to week 28 (week 28 - week 14/16), and from baseline to week 28 (week 28 - baseline).
Levels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16.
Cell-associated HIV-1 RNA data are not available as of August 2017. These data are based on virology assays which are to be tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 3 months after the primary complete date. Upon completion of the testing, the results will be reviewed for data completeness and quality. After resolution of any issues and finalization of the database, the analysis can be conducted and the results will then be posted to ClinicalTrials.gov. We anticipate to enter these results by December 2017."|baseline, week 14/16, week 28||12/2017||||
654139|NCT01969058|Secondary|Change in Cell-associated HIV-1 DNA|"Change in genomic HIV-1 DNA in blood from baseline to week 14/16(week 14/16 - baseline), from week 14/16 to week 28 (week 28 - week 14/16), and from baseline to week 28 (week 28 - baseline).
Levels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16.
Cell-assciated HIV-1 DNA data are not available as of August 2017. These data are based on virology assays which are to be tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 3 months after the primary complete date. Upon completion of the testing, the results will be reviewed for data completeness and quality. After resolution of any issues and finalization of the database, the analysis can be conducted and the results will then be posted to ClinicalTrials.gov. We anticipate to enter these results by December 2017."|baseline, week 14/16, week 28||12/2017||||
654140|NCT01969058|Secondary|Change in Th17 Frequency|"Th17 (T-helper 17) cells are a subset of pro-inflammatory T helper cells defined by their production of interleukin 17 (IL-17).
The outcome is the change in Th17 frequency from baseline to week 14/16 (week 14/16 - baseline), from week 14/16 to week 28 (week 28 - week 14/16), and from baseline to week 28 (week 28 - baseline).
Levels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16.
Th17 data are not available as of August 2017. These data are based on immunology assays which are to be tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 3 months after the primary complete date. Please note that these secondary outcomes are not included in the primary analyses. There are many outcomes in this study and the lab had to give priority to the assays planned to be included in the primary manuscript."|baseline, week 14/16, week 28||12/2017||||
654141|NCT01969058|Secondary|Change in Treg Frequency|"Treg (T Regulatory) Cells are a subpopulation of T cells which modulate the immune system.
The outcome measure is the change in Treg frequency from baseline to week 14/16 (week 14/16 - baseline), from week 14/16 to week 28 (week 28 - week 14/16), and from baseline to week 28 (week 28 - baseline).
Levels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16.
Data for Treg frequency are not available as of August 2017. These data are based on immunology assays which are to be tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 3 months after the primary complete date. Please note that these secondary outcomes are not included in the primary analyses. There are many outcomes in this study and the immunology lab had to give priority to the assays planned to be included in the primary manuscript."|baseline, week 14/16, week 28||12/2017||||
654142|NCT01969058|Secondary|Change in CD4+ T-cell Count|"Change in peripheral total CD4 cell count from baseline to week 14/16 (week 14/16 - baseline), from week 14/16 to week 28 (week 28 - week 14/16), and from baseline to week 28 (week 28 - baseline).
Levels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16."|baseline, week 14/16, week 28|"The analysis is complete case as-treated, and is limited to participants who:
have data for both baseline and week 14/16
(for the Isotretinoin arm) completed treatment (allowing ≤8 missed doses)
did not use prohibited medications
did not experience virologic failure from baseline to week 16"||cells/mm^3||Inter-Quartile Range|Median
654170|NCT01968980|Secondary|Percent Change From Baseline in Triglycerides (TG) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||percent change||Standard Deviation|Mean
655167|NCT01955044|Primary|Long-chain Polyunsaturated Fatty Acid (LCPUFA) Levels|LCPUFA levels will be measured at 2 weeks of life in extremely low birth weight (ELBW) infants|2 weeks of life|2 subjects died prior to having 2 week levels drawn, from causes unrelated to study.||weight % (g/100g)||Inter-Quartile Range|Median
654144|NCT01969058|Secondary|Change in TF|"TF (Tissue Factor) is a marker of Coagulation. Change in log10 transformed TF from baseline to week 14/16 (week 14/16 - baseline), from week 14/16 to week 28 (week 28 - week 14/16), and from baseline to week 28 (week 28 - baseline).
Levels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16."|baseline, week 14/16, week 28|"The analysis is complete case as-treated, and is limited to participants who:
have data for both baseline and week 14/16
(for the Isotretinoin arm) completed treatment (allowing ≤8 missed doses)
did not use prohibited medications
did not experience virologic failure from baseline to week 16"||log10 pg/mL||Inter-Quartile Range|Median
654145|NCT01969058|Secondary|Change in D-dimer|"D-dimer (or D dimer) is a marker of coagulation activation. Change in log10 transformed D-dimer from baseline to week 14/16 (week 14/16 - baseline), from week 14/16 to week 28 (week 28 - week 14/16), and from baseline to week 28 (week 28 - baseline).
Levels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16."|baseline, week 14/16, week 28|"The analysis is complete case as-treated, and is limited to participants who:
have data for both baseline and week 14/16
(for the Isotretinoin arm) completed treatment (allowing ≤8 missed doses)
did not use prohibited medications
did not experience virologic failure from baseline to week 16"||log10 ng/mL||Inter-Quartile Range|Median
654146|NCT01969058|Secondary|Change in sTNF-r2|"sTNF-r2 (soluble tumour necrosis alpha receptor 2) is a marker of inflammation. Change in log10 transformed sTNF-r2 from baseline to week 14/16 (week 14/16 - baseline), from week 14/16 to week 28 (week 28 - week 14/16), and from baseline to week 28 (week 28 - baseline).
Levels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16."|baseline, week 14/16, week 28|"The analysis is complete case as-treated, and is limited to participants who:
have data for both baseline and week 14/16
(for the Isotretinoin arm) completed treatment (allowing ≤8 missed doses)
did not use prohibited medications
did not experience virologic failure from baseline to week 16"||log10 pg/mL||Inter-Quartile Range|Median
654147|NCT01969058|Secondary|Change in sTNF-r1|"sTNF-r1 (soluble tumour necrosis alpha receptor 1) is a marker of inflammation. Change in log10 transformed sTNF-r1 from baseline to week 14/16 (week 14/16 - baseline), from week 14/16 to week 28 (week 28 - week 14/16), and from baseline to week 28 (week 28 - baseline).
Levels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16."|baseline, week 14/16, week 28|"The analysis is complete case as-treated, and is limited to participants who:
have data for both baseline and week 14/16
(for the Isotretinoin arm) completed treatment (allowing ≤8 missed doses)
did not use prohibited medications
did not experience virologic failure from baseline to week 16"||log10 pg/mL||Inter-Quartile Range|Median
654148|NCT01969058|Secondary|Change in hsCRP|"hsCRP (high-sensitivity C-reactive protein) is a marker of inflammation. Change in log10 transformed hsCRP from baseline to week 14/16 (week 14/16 - baseline), from week 14/16 to week 28 (week 28 - week 14/16), and from baseline to week 28 (week 28 - baseline).
Levels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16."|baseline, week 14/16, week 28|"The analysis is complete case as-treated, and is limited to participants who:
have data for both baseline and week 14/16
(for the Isotretinoin arm) completed treatment (allowing ≤8 missed doses)
did not use prohibited medications
did not experience virologic failure from baseline to week 16"||log10 ng/mL||Inter-Quartile Range|Median
654149|NCT01969058|Secondary|Change in IL-6|"IL-6 (Interleukin-6) is a marker of systemic inflammation. The outcome measures are changes in log10 transformed IL-6 from baseline to week 14/16 (week 14/16 - baseline), from week 14/16 to week 28 (week 28 - week 14/16), and from baseline to week 28 (week 28 - baseline).
Levels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16."|baseline, week 14/16, week 28|"The analysis is complete case as-treated, and is limited to participants who:
have data for both baseline and week 14/16
(for the Isotretinoin arm) completed treatment (allowing ≤8 missed doses)
did not use prohibited medications
did not experience virologic failure from baseline to week 16"||log10 pg/mL||Inter-Quartile Range|Median
654150|NCT01969058|Secondary|Change in I-FABP|"I-FABP (intestinal-fatty acid binding protein) is a marker of gut microbial translocation. This marker is to replace the originally planned marker plasma LPS.
The outcome measures are changes in log10 transformed I-FABP from baseline to week 14/16 (week 14/16 - baseline), from week 14/16 to week 28 (week 28 - week 14/16), and from baseline to week 28 (week 28 - baseline).
Levels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16."|baseline, week 14/16, week 28|"The analysis is complete case as-treated, and is limited to participants who:
have data for both baseline and week 14/16
(for the Isotretinoin arm) completed treatment (allowing ≤8 missed doses)
did not use prohibited medications
did not experience virologic failure from baseline to week 16"||log10 pg/mL||Inter-Quartile Range|Median
654151|NCT01969058|Secondary|Change in sCD14|"sCD14 (soluble cluster of differentiation 14) is a marker of gut microbial translocation.
The outcome measures are changes in log10 transformed sCD14 from baseline to week 14/16 (week 14/16 - baseline), from week 14/16 to week 28 (week 28 - week 14/16), and from baseline to week 28 (week 28 - baseline).
Levels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16."|baseline, week 14/16, week 28|"The analysis is complete case as-treated, and is limited to participants who:
have data for both baseline and week 14/16
(for the Isotretinoin arm) completed treatment (allowing ≤8 missed doses)
did not use prohibited medications
did not experience virologic failure from baseline to week 16"||log10 pg/mL||Inter-Quartile Range|Median
654152|NCT01969058|Secondary|Change in CD8+ T-cell Activation|"Level of CD8+ T-cell activation was determined by measuring the percentage of cells that expressed both the activation marker CD38+ and Human leukocyte antigen (HLA)-DR+.
The endpoint is measuring the change from week 14/16 to week 28 (week 28 - week 14/16) and from baseline to week 28 (week 28 - baseline).
Baseline is defined as the average of pre-entry and entry, and week 14/16 is defined as the average of week 14 and week 16."|baseline, week 14/16, week 28|"The analysis is complete case as-treated, and is limited to participants who:
have data for both baseline and week 14/16
(for the Isotretinoin arm) completed treatment (allowing ≤8 missed doses)
did not use prohibited medications
did not experience virologic failure from baseline to week 16"||percentage of cells||Inter-Quartile Range|Median
655225|NCT01954160|Secondary|Serum Cystatin C|Study terminated early, endpoints not measured|13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.|||||
654153|NCT01969058|Primary|Change in CD8+ T-cell Activation From Baseline to Week 14/16|"Level of CD8+ T-cell activation was determined by measuring the percentage of cells that expressed both the activation marker CD38+ and Human leukocyte antigen (HLA)-DR+. The endpoint is measuring the change from baseline to week 14/16, where baseline is defined as the average of pre-entry and entry, and week 14/16 is defined as the average of week 14 and week 16.
Change = (week 14/16 - baseline)."|baseline, week 14/16|"The primary analysis is complete case as-treated, and is limited to participants who:
have data for both baseline and week 14/16
(for the Isotretinoin arm) completed treatment (allowing ≤8 missed doses)
did not use prohibited medications
did not experience virologic failure from baseline to week 16"||percentage of cells||Inter-Quartile Range|Median
654154|NCT01968980|Secondary|Percentage of Participants With Positive Anti­Drug Antibodies (ADA) and Neutralizing Antibodies (nAb)|Percentage of participants with at least 1 positive ADA titer or 1 positive nAb titer were reported in this outcome measure. ADA titer greater than or equal to (>=) 6.23 were considered as ADA positive and nAb titer level >=1.58 were considered as nAb positive.|Baseline up to the end of study (up to 58 weeks)|Analysis was performed on all participants who received at least 1 dose of PF-04950615.||percentage of participants|||Number
654155|NCT01968980|Secondary|Number of Participants With Adverse Events Related to Type 1 or 3 Hypersensitivity Reactions and Injection Site Reactions|Type 1 hypersensitivity or allergic reactions were possible in response to any injected protein and included shortness of breath, urticaria, anaphylaxis and angioedema. Type 3 hypersensitivity reactions were similar to Type 1 hypersensitivity reactions but were likely to be delayed from the time of injection and included symptoms such as rash, urticaria, polyarthritis, myalgia, polysynovitis, fever and if severe then included glomerulonephritis as well. Injection site reaction is a reaction at the site of the subcutaneous injection and characterized by the symptoms of erythema, swelling, tenderness and warmth. Participants with any of the above type 1 or type 3 hypersensitivity reactions and participants with any of the above injection site reactions were reported in this outcome measure.|Baseline up to the end of study (up to 58 weeks)|Safety analysis set included all participants who received at least 1 dose of study treatment.||participants|||Number
654156|NCT01968980|Secondary|Plasma PF-04950615 Concentrations at Week 12, 24 and 52||Week 12, 24, 52|Analysis was performed on all participants who received at least 1 dose of PF-04950615. Here, ‘n’ signifies those participants who were evaluable at specified time points.||microgram per milliliter||Standard Deviation|Mean
654157|NCT01968980|Secondary|Percentage of Participants Achieving Low Density Lipoprotein Cholesterol (LDL-C) Level Less Than or Equal to (<=) 70 Milligram Per Deciliter (1.81 Millimoles Per Liter) at Week 12, 24 and 52||Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||percentage of participants|||Number
654158|NCT01968980|Secondary|Percentage of Participants Achieving Low Density Lipoprotein Cholesterol (LDL-C) Level Less Than or Equal to (<=) 100 Milligram Per Deciliter (2.59 Millimoles Per Liter) at Week 12, 24 and 52||Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||percentage of participants|||Number
654159|NCT01968980|Secondary|Absolute Change From Baseline in Ratio of Apolipoprotein B to Apolipoprotein A-I (ApoB/ApoA-I Ratio) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||ratio||Standard Deviation|Mean
654160|NCT01968980|Secondary|Absolute Change From Baseline in Ratio of Total Cholesterol to High Density Lipoprotein Cholesterol (TC/HDL-C Ratio) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||ratio||Standard Deviation|Mean
654161|NCT01968980|Secondary|Absolute Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12||Baseline, Week 12|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||mg/dL||Standard Deviation|Mean
654162|NCT01968980|Secondary|Absolute Change From Baseline in Lipoprotein (a) at Week 12||Baseline, Week 12|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||mg/dL||Standard Deviation|Mean
654163|NCT01968980|Secondary|Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12||Baseline, Week 12|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||mg/dL||Standard Deviation|Mean
654164|NCT01968980|Secondary|Absolute Change From Baseline in Non- High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12||Baseline, Week 12|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||mg/dL||Standard Deviation|Mean
654165|NCT01968980|Secondary|Absolute Change From Baseline in Total Cholesterol (TC) at Week 12||Baseline, Week 12|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||mg/dL||Standard Deviation|Mean
654166|NCT01968980|Secondary|Absolute Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 12||Baseline, Week 12|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||milligram per deciliter (mg/dL)||Standard Deviation|Mean
654167|NCT01968980|Secondary|Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||percent change||Standard Deviation|Mean
654168|NCT01968980|Secondary|Percent Change From Baseline in Apolipoprotein A-II (ApoA-II) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||percent change||Standard Deviation|Mean
654169|NCT01968980|Secondary|Percent Change From Baseline in Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||percent change||Standard Deviation|Mean
654171|NCT01968980|Secondary|Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 24 and 52||Baseline, Week 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||percent change||Standard Deviation|Mean
654172|NCT01968980|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 24 and 52||Baseline, Week 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||percent change||Standard Deviation|Mean
654173|NCT01968980|Secondary|Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 24 and 52||Baseline, Week 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||percent change||Standard Deviation|Mean
654174|NCT01968980|Secondary|Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 24 and 52||Baseline, Week 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||percent change||Standard Deviation|Mean
654175|NCT01968980|Secondary|Percent Change From Baseline in Total Cholesterol (TC) at Week 24 and 52||Baseline, Week 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||percent change||Standard Deviation|Mean
654176|NCT01968980|Secondary|Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 and 52||Baseline, Week 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||percent change||Standard Deviation|Mean
654177|NCT01968980|Secondary|Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12||Baseline, Week 12|"FAS included all participants who were randomized. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."||percent change||Standard Deviation|Mean
654178|NCT01968980|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 12||Baseline, Week 12|"FAS included all participants who were randomized. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."||percent change||Standard Deviation|Mean
654179|NCT01968980|Secondary|Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12||Baseline, Week 12|"FAS included all participants who were randomized. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."||percent change||Standard Deviation|Mean
654180|NCT01968980|Secondary|Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12||Baseline, Week 12|"FAS included all participants who were randomized. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."||percent change||Standard Deviation|Mean
654181|NCT01968980|Secondary|Percent Change From Baseline in Total Cholesterol (TC) at Week 12||Baseline, Week 12|"FAS included all participants who were randomized. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."||percent change||Standard Deviation|Mean
654182|NCT01968980|Primary|Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12||Baseline, Week 12|"FAS included all participants who were randomized. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."||percent change||Standard Deviation|Mean
654183|NCT01968967|Secondary|Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb)|Percentage of participants with at least 1 positive ADA titer or 1 positive nAb titer were reported. ADA titer >=6.23 was considered to be ADA positive and nAb titer >=1.58 was considered to be nAb positive.|Baseline up to end of study (up to Week 58)|"Safety analysis population included all participants who received at least 1 dose of study treatment. Here, N signifies those participants who were evaluable for this outcome measure for each reporting arm respectively."||Percentage of participants|||Number
654184|NCT01968967|Secondary|Number of Participants With Adverse Events (AEs) Related to Type 1 or 3 Hypersensitivity Reactions and Injection Site Reactions|Type 1 hypersensitivity or allergic reactions were possible in response to any injected protein and included shortness of breath, urticaria, anaphylaxis and angioedema. Type 3 hypersensitivity reactions were similar to Type 1 hypersensitivity reactions but were likely to be delayed from the time of injection and included symptoms such as rash, urticaria, polyarthritis, myalgia’s, polysynovitis, fever and if severe then included glomerulonephritis. Injection site reactions included injection site bruising, discolouration, erythema, haematoma, haemorrhage, nodule, induration, inflammation, mass, pain, paraesthesia, pruritus, swelling, vesicles, warmth, scab and rash. Participants with type 1 or type 3 hypersensitivity reactions and participants with injection site reactions were reported in this outcome measure.|Baseline up to end of study (up to Week 58)|Safety analysis set included all participants who received at least 1 dose of study treatment.||participants|||Number
654185|NCT01968967|Secondary|Plasma Concentration of PF-04950615 at Week 12, 24 and 52|Plasma concentration of PF-04950615 at Week 12, 24 and 52 was reported.|Week 12, 24, 52|"Analysis set included participants who received at least 1 dose of PF-04950615. Here, n signifies those participants who were evaluable at specified time points."||Microgram per milliliter||Standard Deviation|Mean
654186|NCT01968967|Secondary|Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 70 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52||Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm respectively.||percentage of participants|||Number
654187|NCT01968967|Secondary|Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 100 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52||Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm respectively.||percentage of participants|||Number
654188|NCT01968967|Secondary|Change From Baseline in Ratio of Fasting Apolipoprotein B (ApoB) to Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"FAS included all participants who were randomized. Here, n signifies number of participants evaluable at specified time points."||Ratio||Standard Deviation|Mean
654189|NCT01968967|Secondary|Absolute Change From Baseline in Ratio of Fasting Total Cholesterol (TC) to High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."||Ratio||Standard Deviation|Mean
654190|NCT01968967|Secondary|Absolute Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12||Baseline, Week 12|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."||mg/dL||Standard Deviation|Mean
654191|NCT01968967|Secondary|Absolute Change From Baseline in Fasting Lipoprotein (a) (Lp[a]) at Week 12||Baseline, Week 12|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."||mg/dL||Standard Deviation|Mean
654192|NCT01968967|Secondary|Absolute Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12||Baseline, Week 12|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."||mg/dL||Standard Deviation|Mean
654193|NCT01968967|Secondary|Absolute Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (HDL-C) at Week 12||Baseline, Week 12|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."||mg/dL||Standard Deviation|Mean
654194|NCT01968967|Secondary|Absolute Change From Baseline in Fasting Total Cholesterol (TC) at Week 12||Baseline, Week 12|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."||mg/dL||Standard Deviation|Mean
654195|NCT01968967|Secondary|Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12||Baseline, Week 12|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."||mg/dL||Standard Deviation|Mean
654196|NCT01968967|Secondary|Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Greater Than or Equal to (>=) 200 Milligram Per Deciliter (mg/dL) at Week 12||Baseline, Week 12|"A subset of FAS included all participants who were randomized and had TG >=200 mg/dL at pre-randomization. Here, n signifies number of participants evaluable at specified time points."||mg/dL||Standard Deviation|Mean
654197|NCT01968967|Secondary|Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Less Than (<) 200 Milligram Per Deciliter (mg/dL) at Week 12||Baseline, Week 12|"A subset of FAS included all participants who were randomized and had TG <200 mg/dL at pre-randomization. Here, n signifies number of participants evaluable at specified time points."||mg/dL||Standard Deviation|Mean
654198|NCT01968967|Secondary|Percent Change From Baseline in Fasting Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."||percent change||Standard Deviation|Mean
654199|NCT01968967|Secondary|Percent Change From Baseline in Fasting Apolipoprotein A-II (ApoA-II) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."||percent change||Standard Deviation|Mean
654200|NCT01968967|Secondary|Percent Change From Baseline in Fasting Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."||percent change||Standard Deviation|Mean
654201|NCT01968967|Secondary|Percent Change From Baseline in Fasting Triglycerides (TG) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."||percent change||Standard Deviation|Mean
654202|NCT01968967|Secondary|Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 and 52||Baseline, Week 24, 52|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."||percent change||Standard Deviation|Mean
654203|NCT01968967|Secondary|Percent Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."||percent change||Standard Deviation|Mean
654204|NCT01968967|Secondary|Percent Change From Baseline in Fasting Lipoprotein (a) (Lp[a]) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at the specified time points."||percent change||Standard Deviation|Mean
654205|NCT01968967|Secondary|Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Greater Than or Equal to (>=) 200 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"A subset of FAS included all participants who were randomized and had TG >=200 mg/dL at pre-randomization. Here, n signifies number of participants evaluable at specified time points."||percent change||Standard Deviation|Mean
654206|NCT01968967|Secondary|Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides (TG) Cut-off of Less Than (<) 200 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"A subset of FAS included all participants who were randomized and had TG <200 mg/dL at pre-randomization. Here, n signifies number of participants evaluable at specified time points."||percent change||Standard Deviation|Mean
654207|NCT01968967|Secondary|Percent Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at the specified time points."||percent change||Standard Deviation|Mean
654208|NCT01968967|Secondary|Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at the specified time points."||percent change||Standard Deviation|Mean
654209|NCT01968967|Secondary|Percent Change From Baseline in Fasting Total Cholesterol (TC) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at the specified time points."||percent change||Standard Deviation|Mean
654210|NCT01968967|Primary|Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12||Baseline, Week 12|"FAS included all participants who were randomized. Here, Number of participants analyzed (N) signifies number of participants who were evaluable for this outcome measure."||percent change||Standard Deviation|Mean
654211|NCT01968954|Other Pre-specified|Absolute Change From Baseline in ApolipoproteinA-II (ApoA-II) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.||mg/dL||Standard Deviation|Mean
654212|NCT01968954|Other Pre-specified|Absolute Change From Baseline in ApolipoproteinA-I (ApoA-I) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.||mg/dL||Standard Deviation|Mean
654213|NCT01968954|Other Pre-specified|Absolute Change From Baseline in Triglyceride (TG) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.||mg/dL||Standard Deviation|Mean
654214|NCT01968954|Secondary|Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb)|Percentage of participants with at least 1 positive ADA titer or 1 positive nAb titer were reported. Participants with their ADA titer >=6.23 were considered to be ADA positive and participants with their nAb titer >=1.58 were considered to be nAb positive.|Baseline up to the end of study (up to 58 weeks)|"Safety analysis set included all participants who received at least 1 dose of study treatment. Participants who received at least 1 dose of PF-04950615 were evaluable for this outcome measure. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."||percentage of participants|||Number
654215|NCT01968954|Secondary|Number of Participants With Adverse Events (AEs) Related to Type 1 or 3 Hypersensitivity Reactions and Injection Site Reactions|Type 1 hypersensitivity or allergic reactions were possible in response to any injected protein and included shortness of breath, urticaria, anaphylaxis and angioedema. Type 3 hypersensitivity reactions were similar to Type 1 hypersensitivity reactions but were likely to be delayed from the time of injection and included symptoms such as rash, urticaria, polyarthritis, myalgia’s, polysynovitis, fever and if severe then included glomerulonephritis as well. Injection site reactions included injection site bruising, discolouration, erythema, haematoma, haemorrhage, nodule, induration, pain, pruritus and rash. Participants with type 1 or type 3 hypersensitivity reactions and participants with injection site reactions were reported in this outcome measure.|Baseline up to the end of study (up to 58 weeks)|Safety analysis set included all participants who received at least 1 dose of study treatment.||participants|||Number
654216|NCT01968954|Secondary|Plasma PF-04950615 Concentrations at Week 12, 24 and 52||Week 12, 24, 52|Analysis set included participants who received at least 1 dose of PF-04950615. Here, ‘n’ signifies those participants who were evaluable at specified time points.||microgram per milliliter||Standard Deviation|Mean
654217|NCT01968954|Secondary|Percentage of Participants Achieving Fasting Low Density Lipoprotein-Cholesterol (LDL-C) Less Than or Equal to (<=) 70 Milligram Per Deciliter (1.81 Millimoles Per Litre) at Week 12, 24 and 52||Week 12, 24 and 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.||percentage of participants|||Number
654218|NCT01968954|Secondary|Percentage of Participants Achieving Fasting Low Density Lipoprotein-Cholesterol (LDL-C) Less Than or Equal to (<=) 100 Milligram Per Deciliter (2.59 Millimoles Per Litre) at Week 12, 24 and 52||Week 12, 24 and 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.||percentage of participants|||Number
654219|NCT01968954|Secondary|Absolute Change From Baseline in Ratio of Apolipoprotein B to ApolipoproteinA-I (ApoB/ApoA-I Ratio) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.||ratio||Standard Deviation|Mean
654220|NCT01968954|Secondary|Absolute Change From Baseline in Ratio of Fasting Total Cholesterol to High Density Lipoprotein-Cholesterol (TC/HDL-C Ratio) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.||ratio||Standard Deviation|Mean
654221|NCT01968954|Secondary|Absolute Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.||mg/dL||Standard Deviation|Mean
654222|NCT01968954|Secondary|Absolute Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.||mg/dL||Standard Deviation|Mean
654223|NCT01968954|Secondary|Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.||mg/dL||Standard Deviation|Mean
654224|NCT01968954|Secondary|Absolute Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.||mg/dL||Standard Deviation|Mean
654225|NCT01968954|Secondary|Absolute Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.||mg/dL||Standard Deviation|Mean
654226|NCT01968954|Secondary|Absolute Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.||mg/dL||Standard Deviation|Mean
654392|NCT01965899|Primary|Success of Wireless Transmissions|To assess the percentage of successful automatic wireless transmissions from the system within the first 30 days of implant.|30 days|All 151 subjects received a CareLink monitor software update. Subjects contributed 4,511 follow-up days in their first 30 days.||percentage of successful transmissions|Participants|95% Confidence Interval|Number
654227|NCT01968954|Secondary|Absolute Change From Baseline in Fasting Low Density Lipoprotein-C (LDL-C) at Week 12 by Trigylceride Cut-Off|Absolute change from baseline among participants with TG cut-off of <200 mg/dL and >=200 mg/dL (2.26 mmol/L) were reported in this outcome measure.|Baseline, Week 12|FAS included all participants who were randomized.‘Number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm.||mg/dL||Standard Deviation|Mean
654228|NCT01968954|Secondary|Percent Change From Baseline in Very Low Density Lipoprotein-Cholesterol (VLDL-C) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.||percent change||Standard Deviation|Mean
654229|NCT01968954|Secondary|Percent Change From Baseline in ApolipoproteinA-II (ApoA-II) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.||percent change||Standard Deviation|Mean
654230|NCT01968954|Secondary|Percent Change From Baseline in ApolipoproteinA-I (ApoA-I) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.||percent change||Standard Deviation|Mean
654231|NCT01968954|Secondary|Percent Change From Baseline in Fasting Triglyceride (TG) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.||percent change||Standard Deviation|Mean
654232|NCT01968954|Secondary|Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 and 52 by Triglyceride Cut-off|Percent change from baseline in fasting LDL-C among participants with TG cut-off of <200 mg/dL and >=200 mg/dL (2.26 mmol/L) were reported in this outcome measure.|Baseline, Week 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.||percent change||Standard Deviation|Mean
654233|NCT01968954|Secondary|Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 24 and 52||Baseline, Week 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.||percent change||Standard Deviation|Mean
654234|NCT01968954|Secondary|Percent Change From Baseline in Fasting Low-Density Lipoprotein-Cholesterol (LDL-C) at Week 12 in Participants With Mixed Dyslipidemia|Participants with mixed dyslipidemia are defined as TG level greater than or equal to (>=) 200 mg/dL (2.26 mmol/L) at pre-randomization.|Baseline, Week 12|"FAS included all participants who were randomized. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."||percent change||Standard Deviation|Mean
654235|NCT01968954|Secondary|Percent Change From Baseline in Fasting Low-Density Lipoprotein-Cholesterol (LDL-C) at Week 12 in Participants With Primary Hyperlipidemia|Participants with primary hyperlipidemia are defined as participants with triglycerides (TG) level less than (<) 200 milligram per decilitre (mg/dL) (2.26 millimoles per litre [mmol/L]) at pre-randomization.|Baseline, Week 12|"FAS included all participants who were randomized. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."||percent change||Standard Deviation|Mean
654236|NCT01968954|Secondary|Percent Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.||percent change||Standard Deviation|Mean
654237|NCT01968954|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.||percent change||Standard Deviation|Mean
654238|NCT01968954|Secondary|Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.||percent change||Standard Deviation|Mean
654239|NCT01968954|Secondary|Percent Change From Baseline in Non- High Density Lipoprotein-Cholesterol (Non HDL-C) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.||percent change||Standard Deviation|Mean
654240|NCT01968954|Secondary|Percent Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.||percent change||Standard Deviation|Mean
654241|NCT01968954|Primary|Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12||Baseline, Week 12|"FAS included all participants who were randomized. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."||percent change||Standard Deviation|Mean
654242|NCT01968811|Primary|To Evaluate the Performance of the Dressing Kit as Part of a Negative Pressure System in Post Market Clinical Follow-up Settings|"Outcome of each subject was evaluated and presented individually. Questionnaires answered by surgeon at application and removal of the kit; Baseline Overall ease of application of the kit: No. of surgeons rated as; Very easy= 4/Easy=3/Somewhat easy=2/Not easy Overall satisfaction with the kit:No. of surgeons rated as Very satisfied=3/ Satisfied=5/ Unsatisfied=2/ Very unsatisfied=0
Questionnaires were answered by surgeon at application and removal of the kit; Visit 2 Overall ease of application of the kit:No.of surgeons rated as Very easy= 2/Easy=5/Somewhat easy=0/Not easy=1 Overall satisfaction with the kit: No.of surgeons rated as Very satisfied=1/ Satisfied=3/ Unsatisfied=4/ Very unsatisfied=0 Visit 3 Overall ease of application of the kit: No.of surgeons rated as Very easy= 0/Easy=6/Somewhat easy=0/Not easy=0 Overall satisfaction. No of surgeons rated as Very satisfied=0, satisfied=4, unsatisfied=2, very unsatisfied=0"|From 1 to 3 visit, depending on each subject/wound, up to 4 days.|10 patients were enrolled and individually analysed and presented in the study||number of surgeons|||Number
654243|NCT01968811|Secondary|- Fascial/Skin Closure of the Open Abdomen|The performance objective is assessed through general application and removal questions after each investigational device handling.|End of treatment, up to 4 days.|No. Analysed for efficacy ITT 10 , PP 9,||participants|||Number
654244|NCT01968694|Secondary|Change in Hospital Anxiety and Depression Scale (HADS)|"The Hospital Anxiety and Depression Scale (HADS) consists of 14 items rated from 0-3 and 2 subscales Depression (7 items) and Anxiety (7 items). A higher score on each item represents more of each symptom (i.e., more depression or more anxiety). Each subscale score is the sum of the 7 items from each subscale.
A score of 0-7 = Normal, 8-10=Borderline abnormal (borderline case), and 11-21=Abnormal (case).
Change scores are calculated from baseline (pre-infusion) at 1 day, 1 week, and 1 month post-treatment:
(1 day post-treatment value - BL pre-infusion value)
(1 week post-treatment value - BL pre-infusion value)
(1 month post-treatment value - BL pre-infusion value)"|1 day, 1 week, and 1 month post-treatment from BL (pre-infusion)|In the IV diphenhydramine arm 1 pt is missing HADS scores at 1 week, and 3 pts are missing scores at 1 month. In the IV Lidocaine arm 3 pts are missing HADS scores at 1 month.||units on a scale||Inter-Quartile Range|Median
654245|NCT01968694|Secondary|Change in Brief Pain Inventory (BPI): Pain on Average|"The Pain on Average score in the Brief Pain Inventory is rated from 0-10, where 0 is no pain, and 10 is pain as bad as you can imagine.
Change scores are calculated from baseline (pre-infusion) at 1 day, 1 week, and 1 month post-treatment:
(1 day post-treatment value - BL pre-infusion value)
(1 week post-treatment value - BL pre-infusion value)
(1 month post-treatment value - BL pre-infusion value)"|1 day, 1 week, and 1 month post-treatment from BL (pre-infusion)|In the IV diphenhydramine arm 1 pt is missing BPI avg pain score at 1 week, and 2 are missing scores at 1 month. In the IV Lidocaine arm 1 pt is missing a score at 1 day, 1 is missing a score at 1 week, and 4 are missing scores at 1 month.||units on a scale||Inter-Quartile Range|Median
654246|NCT01968694|Secondary|Change in Short Form McGill Pain Questionnaire 2|"Short-form McGill Pain Questionnaire version 2 consists of 22 pain items (Throbbing, Shooting, Stabbing, Sharp, Cramping, Gnawing, Hot-burning, Aching, Heavy, Tender, Splitting, Tiring-exhausting, Sickening, Fearful, Punishing-cruel, Electric-shock, Cold-freezing, Piercing, Pain caused by light touch, Itching, Tingling or 'pins and needles', and Numbness). Each item is rated on a scale from 0-10, where 0=none, and 10=worst possible pain. The total pain score is the sum of these 22 items, ranging from 0-220.
Change scores are calculated from baseline (pre-infusion) at 30 minutes, 1 week, and 1 month post-treatment:
(30 minutes post-treatment value - BL pre-infusion value)
(1 week post-treatment value - BL pre-infusion value)
(1 month post-treatment value - BL pre-infusion value)"|30 minutes, 1 week, and 1 month post-treatment from BL (pre-infusion)|"participant in the IV diphenhydramine arm is missing SFMPQ total score 1 week post-treatment.
participants in the IV diphenhydramine arm are missing SFMPQ total score 1 month post-treatment.
participants in the IV Lidocaine arm are missing SFMPQ total score 1 month post-treatment."||units on a scale||Inter-Quartile Range|Median
654247|NCT01968694|Primary|Change in Visual Analogue Scale (VAS)|"Visual Analogue Scale (VAS) ranges from 0 (no pain) to 10 (the worse imaginable pain).
Change scores are calculated from baseline (pre-infusion) at 15 minutes after start of infusion, 30 minutes after start of infusion, and 30 minutes after infusion complete:
(15 minutes after start of infusion value - BL pre-infusion value) (30 minutes after start of infusion value - BL pre-infusion value) (30 minutes after infusion complete value - BL pre-infusion value)"|15 minutes after start of infusion, 30 minutes after start of infusion, and 30 minutes after infusion complete from BL (pre-infusion)|"2 participants in the IV Lidocaine arm are missing VAS 30 minutes after infusion started.
3 participants in the IV Lidocaine arm are missing VAS 30 minutes after infusion complete."||units on a scale||Inter-Quartile Range|Median
654248|NCT01968551|Secondary|Change From Baseline in CD4+ Cell Count at Week 48||Baseline; Week 48|Full Analysis Set (FAS) included participants who (1) were randomized into Cohort 2 and (2) had received at least one dose of study drug during the OL phase of the study. Participants with available data were analyzed.||cells/μL||Standard Deviation|Mean
654249|NCT01968551|Secondary|Change From Baseline in CD4+ Cell Count at Week 24||Baseline; Week 24|Full Analysis Set (FAS) included participants who (1) were randomized into Cohort 2 and (2) had received at least one dose of study drug during the OL phase of the study. Participants with available data were analyzed.||cells/μL||Standard Deviation|Mean
654250|NCT01968551|Secondary|Percentage of Participants in Each Treatment Arm in Cohort 2 With HIV-1 RNA < 50 Copies/mL at Week 48|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Full Analysis Set included participants who (1) were randomized into Cohort 2 and (2) had received at least one dose of study drug during the OL phase of the study.||percentage of participants|||Number
654251|NCT01968551|Primary|Percentage of Participants in Each Treatment Arm in Cohort 2 With HIV-1 RNA < 50 Copies/mL at Week 24|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 24|Full Analysis Set (FAS) in Cohort 2, included all participants who (1) were randomized to Cohort 2 and (2) received at least 1 dose of study drug during the open-label Phase.||percentage of participants|||Number
654252|NCT01968434|Secondary|Change in Day Cough Score at End of Study (From D0 to D4)|"A validated cough questionnaire measuring 3 aspects of daytime cough (frequency, severity, bothersomeness) on a 7 point Likert scale was used each evening to rate the passed day, as regards these aspects. The scale rates each parameter from 0 (not at all) to 6 (extremely). Every day of the trial is rated. The last evening of the study (D4) the parents rated the passed day by scoring from 0-6 each of the 3 aspects of day cough. The summed score for all aspects gives the combined day cough score. This score, ranging between 0-18, was subtracted from the sum of all aspects, also ranging between 0-18, form the basal day cough score of the day before enrollment (D0). This change is recorded as change in combined day cough score and it refers to the change from D0 to D4. Negative values of the change indicate an improvement in the condition of the patient."|4 nights (onset of trial Night 1 to Night 4) and 3 days|Two patients in the protective syrup group, and 5 patients in the carbocysteine group did not complete the questionnaire for the last day.||change in combined day cough score||Standard Error|Mean
654313|NCT01966770|Primary|Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 1)|Investigator rating of fit preference upon contact lens settling of pair 1. Collected at 30 minutes post settling for each lens. Percent of investigators that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strong R, Slight R, No Pref, Slight L, Strong L)|Day 2 - Insertion|||percentage of investigators|||Number
654253|NCT01968434|Secondary|Change in Night Cough Score at End of Study (From N0 to N4)|"A validated cough questionnaire measuring 5 aspects of night cough (frequency, severity, bothersomeness, child sleep and parents' sleep) on a 7 point Likert scale was used each morning to rate the passed night. The scale rates each parameter from 0 (not at all) to 6 (extremely). Every night of the trial is rated. The morning after the last night of the study (N4) the parents rated the passed night by scoring from 0-6 each of the 5 aspects of night cough. The summed score for all aspects gives the combined night cough score. This score, ranging between 0-30, was subtracted from the sum of all aspects, also ranging between 0-30, form the basal night cough score of the night before enrollment (N0). This change is recorded as change in combined night cough score and it refers to the change from N0 to N4. Negative values of the change indicate an improvement in the condition of the patient."|4 nights (onset of trial Night 1 to Night 4) and 3 days|Two patients from the protective syrup group and 6 patients from the carbocysteine group did not anwser the questions for the last night.||change in combined night cough score||Standard Error|Mean
654254|NCT01968434|Primary|Change in Night Cough Score on First Night of Treatment (From N0 to N1)|"Night cough is most bothersome to the child and family. Cough was measured with a validated questionnaire which asks parents to rate 5 aspects of night cough: frequency, severity, bothersomeness, child sleep and parent sleep according to a 7 point Likert scale, from 0 (not at all) to 6 (extremely). Lower scores indicate a better condition. The morning after the first night of treatment (N1) the parents rated the passed night by scoring from 0-6 each of the 5 aspects of night cough. The sum of scores for all 5 aspects gives the combined night cough score. This score, ranging between 0-30, was subtracted from the sum of all aspects, also ranging between 0-30, form the basal night cough score of the night before enrollment (N0). This change is recorded as change in combined night cough score and it refers to the change from N0 to N1. Negative values of the change indicate an improvement in the condition of the patient."|1 night from before enrollement (N0) to first night after treatment (N1)|the population analyzed are the children who completed the protocol and submitted the complete questionnaire for night and day cough||change in combined night cough score||Standard Error|Mean
654255|NCT01968226|Primary|Target to Background Ratio (TBR)|To assess uptake of [F-18]RGD-K5 by carotid plaque with PET/CT imaging (which will be expressed as a target to background ratio (TBR) of the standard uptake value (SUV)) in participants prior to carotid endarterectomy. The TBR of [F-18]RGD-K5 in the plaque will serve as a surrogate marker of plaque inflammation in participants being considered for carotid endarterectomy.|Baseline|no subject analysis done|||||
654256|NCT01968135|Secondary|Number of Days to Recurrence of Bleeding After Discontinuation of Therapy||Up to six months|||days||Full Range|Median
654257|NCT01968135|Secondary|Number of Days Without Bleeding During Therapy||Over the 14 day course of study drug|||days||Full Range|Median
654258|NCT01968135|Secondary|Number of Days Until Temporary Interruption of Bleeding During Therapy Occurred||over the 14 day course of study drug|||days||Full Range|Median
654259|NCT01968135|Primary|Cessation of Vaginal Bleeding|Proportion of women in each group who stopped bleeding during therapy and continued to report no bleeding at the end of the 14-day treatment period.|At day 3 of 14 day course of study drug|||percentage of participants|||Number
654260|NCT01968057|Primary|PK: Time of Maximum Observed Drug Concentration (Tmax) of Baricitinib||Days 1 and 4: predose of baricitinib, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 and 72 hours postdose|All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + ciclosporin in Period 2) and had PK data to calculate Tmax of baricitinib.||hours||Full Range|Median
654261|NCT01968057|Primary|PK: Area Under the Concentration Curve From Time Zero to Infinity [AUC (0-∞)] of Baricitinib||Days 1 and 4: predose of baricitinib, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 and 72 hours postdose|All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + ciclosporin in Period 2) and had PK data to calculate AUC (0-∞) of baricitinib.||nanograms*hour/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
654262|NCT01968057|Primary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of Baricitinib||Days 1 and 4: predose of baricitinib, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 and 72 hours postdose|All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + ciclosporin in Period 2) and had PK data to calculate Cmax of baricitinib.||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
654263|NCT01967940|Secondary|Part 2: PK Parameter: Ctau of TFV, ATV, and EVG|Ctau is defined as the observed drug concentration at the end of the dosing interval.|Week 4 to Week 12||||||
654264|NCT01967940|Secondary|Part 2: PK Parameter: AUCtau of TFV, ATV, and EVG|AUCtau is defined as concentration of drug over time.|Week 4 to Week 12||||||
654265|NCT01967940|Secondary|Part 2: PK Parameter: Cmax of TAF, Tenofovir (TFV), ATV, and Elvitegravir (EVG)|Cmax is defined as the maximum concentration of drug.|Week 4 to Week 12||||||
654266|NCT01967940|Secondary|Part 2: PK Parameter: Clast of TAF|Clast is defined as the last observable concentration of drug.|Week 4 to Week 12||||||
654267|NCT01967940|Secondary|Part 2: Pharmacokinetic (PK) Parameter: AUClast of TAF|AUClast is defined as the concentration of drug from time zero to the last observable concentration|Week 4 to Week 12||||||
654268|NCT01967940|Secondary|Part 2: Change From Baseline in CD4+ Cell Count (Cells/μL) and Percentage at Weeks 24 and 48||Weeks 24 and 48||||||
654269|NCT01967940|Secondary|Part 2: Change From Baseline in Plasma log10 HIV-1 RNA (Copies/mL) at Weeks 24 and 48||Weeks 24 and 48||||||
654270|NCT01967940|Secondary|Part 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL as Defined by the FDA Snapshot Analysis at Weeks 24 and 48||Weeks 24 and 48||||||
654271|NCT01967940|Secondary|Part 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL as Defined by the FDA Snapshot Analysis at Weeks 24 and 48||Weeks 24 and 48||||||
654272|NCT01967940|Secondary|Part 2: Safety of E/C/F/TAF STR Plus ATV in Participants Who Switched From a Failing Regimen as Assessed by the Incidence of Laboratory Parameters and Adverse Events at Weeks 24 and 48||Up to 48 weeks||||||
654273|NCT01967940|Secondary|Part 1: Change From Baseline in Plasma log10 HIV-1 RNA (Copies/mL) at Day 10||Baseline; Day 10|Part 1 Full Analysis Set||log10 copies/mL||Standard Deviation|Mean
654274|NCT01967940|Primary|Part 1: Percentage of Participants With Plasma HIV-1 RNA Decreases From Baseline Exceeding 0.5 log10 at Day 10||Day 10|Part 1 Full Analysis Set: participants who enrolled into Part 1 of the study and received at least one dose of study drug in Part 1.||percentage of participants|||Number
654275|NCT01967836|Secondary|Clinic Nurse Observation of Subjects, Who Used Intervention Device, at the Next Clinic Visit|"The secondary outcomes of the study are clinic nurse observed problems. Percentage of yes responses of nurse observations of site at clinic visit
Line dressing intact (Yes) is in place (reporting on 20 lines on 28 RN observations)
Absence (No) of local skin irritation,
Dislodgement of the IV line/needle (No) with the IV site upon subject return to the clinic and verification by the subject ."|Inspection of central line site and dressing upon return to schduled clinic visit up to 30 days|Nurse questionnaire evaluation forms were completed relative to subjects questionnaires being returned at next clinic visit||percentage of observation|Nurse Observation of IV Site||Number
654276|NCT01967836|Primary|Patient Satisfaction Mean on a 0-10 Likert Scale on the Use of Glad Press 'n Seal During Showering. 40 Subjects Reports.|0 Not at all satisfied 10 Very satisfied|Reported afer each subject showering survey completion|||units on a scale||Standard Deviation|Mean
654277|NCT01967836|Primary|Patient Subject Questionnaire Post Shower Evaluation|"Percentage of responses to evaluation questions (Percentage reported are yes responses) for the following questions. 40 surveys were returned from 11 patient subjects.
Did you need assistance to place the Glad Press 'n Seal to your IV area?
Was the area covered by the Glad Press 'n Seal dry after taking it off?
Was the dressing covering your IV undamaged after taking off the Glad Press 'n Seal?
Did you feel the IV Line was accidentally pulled at all with the use of the Glad Press 'n Seal?
Likert Scale response to the following question On a scale of 0 (would not use) to 10 (would continue to use) how satisfied were you in using Glad Press n Seal?"|complete one evaluation after each shower when using product|10 oncology and 1 ambulatory subjects returned 39 evaluation forms for primary analysis||percentage of yes responses|||Number
654278|NCT01967784|Primary|Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Quadrivalent Influenza Vaccine|Solicited Injection site: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering. Injection site Grade 3 (9 to 11 years): Pain, Incapacitating, unable to perform usual activities; Erythema, Swelling, Induration, and Ecchymosis, ≥ 50 mm. Injection site Grade 3 (12 to 17 years): Pain, Significant; prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis, > 100 mm. Systemic Grade 3 (9 to 17 years): Fever, ≥ 39.0°C; Headache, Malaise, Myalgia, and Shivering, Significant, prevents daily activity.|Day 0 up to Day 7 post-vaccination|Solicited injection site and systemic reactions were analyzed in the Safety Analysis Set.||Percentage of participants|||Number
654279|NCT01967784|Primary|Geometric Mean Titers Ratios of Influenza Antibodies Following Vaccination With a Quadrivalent Influenza Vaccine|Immunogenicity of the Quadrivalent Influenza Vaccine virus was evaluated using the hemagglutination inhibition (HAI) technique.|Day 0 (pre-vaccination) and Day 21 post-vaccination|Geometric mean titers ratios were analyzed in the Immunogenicity Analysis Set.||Titers ratio||95% Confidence Interval|Geometric Mean
654280|NCT01967784|Primary|Percentage of Participants With Seroconversion or Significant Increase in Influenza Antibody Titers Following Vaccination With a Quadrivalent Influenza Vaccine|Immunogenicity of the Quadrivalent Influenza vaccine virus was evaluated using the hemagglutination inhibition (HAI) technique. Seroconversion was defined as participants with a pre-vaccination titer <10 (1/dil) to a post-vaccination titer ≥40 (1/dil) or significant increase was defined as participants with a pre-vaccination titer ≥10 (1/dil) and ≥4-fold increase of the titer.|Day 21 post-vaccination|Seroconversion or significant increase in influenza antibody titers was analyzed in the Immunogenicity Analysis Set.||Percentage of participants|||Number
654281|NCT01967784|Primary|Percentage of Participants With Seroprotection Before and Following Vaccination With a Quadrivalent Influenza Vaccine|Immunogenicity of the Quadrivalent Influenza vaccine virus was evaluated using the hemagglutination inhibition (HAI) technique. Seroprotection was defined as titers ≥ 40 (1/dil) on Day 0 (pre-vaccination) and on Day 21 post-vaccination.|Day 0 (pre-vaccination) and Day 21 post-vaccination|Seroprotection was analyzed in the Immunogenicity Analysis Set.||Percentage of participants|||Number
654282|NCT01967784|Primary|Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Quadrivalent Influenza Vaccine|Immunogenicity of the Quadrivalent Influenza Vaccine virus was evaluated using the hemagglutination inhibition (HAI) technique.|Day 0 (pre-vaccination) and Day 21 post-vaccination|Geometric mean titers were analyzed in the Immunogenicity Analysis Set.||Titers (1/dilution)||95% Confidence Interval|Geometric Mean
654283|NCT01967732|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero (Pre-product Use) to Last Time Point [AUC(0-last)] Following Single Use of THS 2.2, CC and NNS|"Derived from multiple blood sampling on Day 1 and Day 3 (1 blood sampling pre-product use and multiple blood sampling over 24 hours post-product use).
Geometric Least Squares means are provided."|3 days|PK populations consisted of all the randomized subjects who completed at least 1 of the single use days (Days 1 or 3), and for whom at least 1 PK parameter could be derived. Subjects with major protocol deviations that impacted the evaluability of the results were excluded from the PK populations.||h*ng/mL||95% Confidence Interval|Least Squares Mean
654284|NCT01967732|Primary|Maximum Concentration (Cmax) of Nicotine Following Single Use of THS 2.2, CC and NNS|"Derived from multiple blood sampling on Day 1 and Day 3 (1 blood sampling pre-product use and multiple blood sampling over 24 hours post-product use).
Geometric Least Squares means are provided."|3 days|PK populations consisted of all the randomized subjects who completed at least 1 of the single use days (Days 1 or 3), and for whom at least 1 PK parameter could be derived. Subjects with major protocol deviations that impacted the evaluability of the results were excluded from the PK populations.||ng/mL||95% Confidence Interval|Least Squares Mean
654285|NCT01967719|Primary|Area Under the Plasma Nicotine Concentration-Time Curve From Time Zero (Pre-product Use) to Last Time Point [AUC(0-last)] Following Single Use of mTHS 2.2, mCC and NNS|"Derived from multiple blood sampling on Day 1 and Day 3 (1 blood sampling pre-product use and multiple blood sampling over 24 hours post-product use).
Geometric Least Squares means are provided."|3 days|PK populations consisted of all the randomized subjects who completed at least 1 of the single use days (Days 1 or 3), and for whom at least 1 PK parameter could be derived. Subjects with major protocol deviations that impacted the evaluability of the results were excluded from the PK populations.||h*ng/mL||95% Confidence Interval|Least Squares Mean
654373|NCT01966042|Secondary|Functional Change Evaluation|Analysis of objective improvement in myocardial ischemia (in %), by stress technetium scintigraphy.|Baseline, 6 and 12 months|||percentage of area change||Standard Deviation|Median
673114|NCT01664975|Primary|Progression-free Survival||up to end of follow-up-phase (approximately 24 months)|||participants|||Number
654286|NCT01967719|Primary|Maximum Concentration (Cmax) of Nicotine Following Single Use of mTHS 2.2, mCC and NNS|"Derived from multiple blood sampling on Day 1 and Day 3 (1 blood sampling pre-product use and multiple blood sampling over 24 hours post-product use).
Geometric Least Squares (geometric LS) means are provided."|3 days|Pharmacokinetics (PK) populations consisted of all the randomized subjects who completed at least 1 of the single use days (Days 1 or 3), and for whom at least 1 PK parameter could be derived. Subjects with major protocol deviations that impacted the evaluability of the results were excluded from the PK populations.||ng/mL||95% Confidence Interval|Least Squares Mean
654287|NCT01967706|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero (Pre-product Use) to Last Time Point [AUC(0-last)] Following Single Use of mTHS, mCC and NRT|"T0 = start of single product use.
Derived from multiple blood sampling on Day 1 and Day 3 (1 blood sampling pre-product use and multiple blood sampling over 24 hours post-product use).
Geometric Least Squares means are provided."|Blood taken 15 minutes prior to T0, 2, 4, 6, 8, 10, 15, 30, 45 minutes, 1, 2, 4, 6, 9, 12, and 24 hours after T0|PK populations consisted of all the randomized subjects who completed at least 1 of the single use days (Days 1 or 3), and for whom at least 1 PK parameter could be derived. Subjects with major protocol deviations that impacted the evaluability of the results were excluded from the PK populations.||ng*h/mL||95% Confidence Interval|Least Squares Mean
654288|NCT01967706|Primary|Maximum Concentration (Cmax) of Nicotine Following Single Use of mTHS, mCC and NRT|"T0 = start of single product use.
Derived from multiple blood sampling on Day 1 and Day 3 (1 blood sampling pre-product use and multiple blood sampling over 24 hours post-product use).
Geometric Least Squares means are provided."|Blood taken 15 minutes prior to T0, 2, 4, 6, 8, 10, 15, 30, 45 minutes, 1, 2, 4, 6, 9, 12, and 24 hours after T0|PK populations consisted of all the randomized subjects who completed at least 1 of the single use days (Days 1 or 3), and for whom at least 1 PK parameter could be derived. Subjects with major protocol deviations that impacted the evaluability of the results were excluded from the PK populations.||ng/mL||95% Confidence Interval|Least Squares Mean
654289|NCT01967550|Primary|Measure: Pain On Movement (POM)|POM will be assessed by subject on a 100 mm Visual Analog Scale (VAS). The VAS ranges from 0 to 100 with higher score indicating higher levels of pain.|2 weeks|The modified ITT (mITT) population excludes subjects in the ITT population who were incorrectly instructed by the investigator to treat only one knee. The mITT population is primary for the analysis of efficacy.||units on a scale||Standard Deviation|Mean
654290|NCT01967342|Secondary|Patient Global Impression of Change (PGIC), Pain Intensity|"The Patient Global Impression of Change (PGIC) assesses self-perceived changes in pain intensity. Scores were dichotomized such that responses of very much better and much better were recoded as 1 and all other responses were coded as zero, as performed by Cherkin et al. (2016), in order to indicate clinically meaningful improvement on pain intensity. The following outcome measure data table reports the number of participants per group reporting clinically meaningful improvement at post-treatment (10-weeks) and follow-up (6-months)."|Retrospective self-report at post-treatment (10-weeks) and follow-up (6-months).|Only participants who completed the post-treatment (10-weeks) and follow-up (6-months) assessments were included in the following analyses.||Participants|||Count of Participants
654291|NCT01967342|Secondary|Patient Health Questionnaire - 9 (PHQ-9)|Depressive symptoms were assessed using the Patient Health Questionnaire-9 (PHQ-9; range 0-27; higher scores indicate greater severity).|Post-treatment (10-weeks) and follow-up (6 months)|The predicted mean estimates were based on latent growth modeling from mplus using all participants.||units on a scale||Standard Deviation|Mean
654292|NCT01967342|Secondary|Brief Pain Inventory-Interference (BPI-Interference)|Brief Pain Inventory-Intensity indicates level of pain interference. Higher scores (range 0-10) reflect higher perceived pain interference.|Post-treatment (10-weeks) and follow-up (6 months)|The predicted mean estimates were based on latent growth modeling from mplus using all participants.||units on a scale||Standard Deviation|Mean
654293|NCT01967342|Primary|Brief Pain Inventory-Intensity (BPI-Intensity)|Brief Pain Inventory-Intensity indicates level of pain intensity. Higher scores (range 0-10) reflect higher perceived pain severity.|Post-treatment (10-weeks) and follow-up (6 months)|The predicted mean estimates were based on latent growth modeling from mplus using all participants.||units on a scale||Standard Deviation|Mean
654294|NCT01967277|Primary|Absolute Increase in Terminal Hair Counts From Pre-Treatment, Baseline for Active Test Subjects Over the Placebo Test Subjects.|At baseline, a 25 mm area of treatment was trimmed of hair (to 3mm) at the vertex of the scalp and photographs were taken, terminal hairs were counted.|baseline and 17 weeks|||terminal hairs||Standard Deviation|Mean
654295|NCT01967277|Primary|Percentage Increase in Terminal Hair Counts From Pre-Treatment, Baseline for Active Test Subjects Over the Placebo Test Subjects.|At baseline, a 25 mm area of treatment was trimmed of hair (to 3mm) at the vertex of the scalp and photographs were taken, terminal hairs were counted.|baseline and 17 weeks|||percent change||Standard Deviation|Mean
654296|NCT01967147|Secondary|Change From Baseline in IDEEL Treatment Inconvenience Score at Day 35|The IDEEL is a 10-item questionnaire designed to assess the subject's general satisfaction with treatment use. The subject responded to treatment inconvenience questions (Questions 6, 8-10) using a 0-4 Likert-type scale, where 0=All of the time and 4=None of the time. The IDEEL treatment inconvenience score was calculated as the sum of the responses from Questions 6, 8-10 divided by the number of questions (6, 8-10) answered, multiplied by 25, for a resultant overall score of 0-100. A positive change number represents perceived improvement.|Baseline (Day 0), Day 35|This analysis population includes all randomized subjects.||units on a scale||Standard Error|Mean
654297|NCT01967147|Secondary|Change From Baseline in IDEEL Treatment Effectiveness Score at Day 35|The IDEEL is a 10-item questionnaire designed to assess the subject's general satisfaction with treatment use. The subject responded to treatment effectiveness questions (Questions 2-5) using a 0-4 Likert-type scale, where 0=None of the time and 4=All of the time. The IDEEL treatment effectiveness score was calculated as the sum of the responses from Questions 2-5 divided by the number of questions (2-5) answered, multiplied by 25, for a resultant overall score of 0-100. A positive change number represents perceived improvement.|Baseline (Day 0), Day 35|This analysis population includes all randomized subjects.||units on a scale||Standard Error|Mean
654391|NCT01965899|Primary|R-wave Amplitude|To characterize the signal quality of the R-wave amplitude at implant and one month.|30 days|For each subject implanted with a Reveal LINQ device an R-wave amplitude measurement is collected at implant and 1 month follow-up.||μV||Standard Deviation|Mean
654298|NCT01967147|Secondary|Change From Baseline in OSDI Score at Day 35|The OSDI is a 12-item quality of life questionnaire designed to assess ocular surface symptoms, their severity, and their impact on the subject's ability to function. Each item was scored by the subject on a 0-4 Likert-type scale (0=None, 4=All of the Time), with a resultant overall score of 0-100 (0=no disability, 100=complete disability). A negative change number represents a perceived improvement in ocular health.|Baseline (Day 0), Day 35|This analysis population includes all randomized subjects.||units on a scale||Standard Error|Mean
654299|NCT01967147|Secondary|Change From Baseline in TOSS Score at Day 35|The TOSS score (a cumulative cornea and conjunctival staining score) was assessed by the investigator using ophthalmic dye and a biomicroscope. Three areas of the ocular surface were graded for dryness on a 0-5 scale (0=Absent, 5=Severe), with a resultant overall score of 0-15. A negative change indicates an improvement in dry eye-related staining. One eye (study eye) contributed to the analysis.|Baseline (Day 0), Day 35|This analysis population includes all randomized subjects.||units on a scale||Standard Error|Mean
654300|NCT01967147|Primary|Change From Baseline in TFBUT at Day 35|TFBUT (the time required for dry spots to appear on the corneal surface after blinking) was assessed by the investigator using ophthalmic dye and a biomicroscope and measured in seconds. Subjects were dosed in the office 1 hour ±10 minutes prior to TFBUT assessment. A shorter TFBUT indicates a higher likelihood of dry eye symptoms. A positive change indicates an improvement in TFBUT. One eye (study eye) contributed to the analysis.|Baseline (Day 0), Day 35|This analysis population includes all randomized subjects.||seconds||Standard Error|Mean
654301|NCT01967121|Primary|Pain Scores on the Visual Analog Scale|Visual Analog Scale for Muscle Soreness scale The scale for measuring the intensity of muscle soreness will be a 10 cm visual analog scale, spaced by one centimeter increments from one to 10. Ten will represent the maximum amount of soreness and zero represents no soreness at all. Subjects will be asked to complete this scale once per day at the same time of day until the soreness has dissipated. The Visual Analog Scale for muscle soreness is measured as 'scores on a scale'.|Day 1 through Day 5|||scores on a scale||Standard Deviation|Mean
654302|NCT01967069|Primary|Percentage of Participants With Treatment Success According to the Investigator's Global Assessment (IGA)|IGA of clear or almost clear|Day 15|Intent to Treat||percentage of subjects||95% Confidence Interval|Number
654303|NCT01966926|Secondary|Changes in Perceptions of Weight Tracking|Perceptions of weight tracking (ease of remembering and understanding, usefulness, awareness, interest, reward value, satisfaction, motivational value) were assessed at three and six months using a scale created for the study. The scale has a range of 0 to 64, with higher scores indicating greater perceptions of favorability of weight tracking. A comparison of perceptions scores between groups and over time from 3 and 6 months was considered a secondary outcome and analyzed using repeated measures MANOVA.|three to six months|||units on a scale||Standard Deviation|Mean
654304|NCT01966926|Secondary|Changes in Barriers to Weight Tracking|Perceived barriers to self-weighing were assessed at baseline, three, and six months using a scale created for this study. The scale has a range of 18 to 90, with higher scores indicating greater perceptions of barriers to self-weighing. A comparison of barriers scores between groups and over time from baseline to 3 and 6 months was considered a secondary outcome and analyzed using repeated measures MANOVA.|baseline to 6 months|||units on a scale||Standard Deviation|Mean
654305|NCT01966926|Secondary|Changes in Body Image|Changes in self-reported body image were assessed at baseline, three, and six months using the Appearance subscale of the Multidimensional Body Image Questionnaire. The subscale has a range of 0 to 42, with higher scores indicating better body image. A comparison of body image scores between groups and over time from baseline to 3 and 6 months was considered a secondary outcome and analyzed using repeated measures MANOVA.|baseline to 6 months|||units on a scale||Standard Deviation|Mean
654306|NCT01966926|Secondary|Changes in Anxiety|Ratings of anxiety, assessed by the Beck Anxiety Inventory, were assessed at baseline, three, and six months; a comparison of anxiety scores between groups and over time from baseline to 3 and 6 months was considered a secondary outcome and analyzed using repeated measures MANOVA. Possible scores on the scale range from 0-63. Scores from 0-7 indicate minimal anxiety; 8-15 = mild anxiety; 16-25 = moderate anxiety; 26-63 = severe anxiety.|baseline to 6 months|||units on a scale||Standard Deviation|Mean
654307|NCT01966926|Secondary|Changes in Depression Ratings|Ratings of depressed mood, assessed by the Beck Depression Inventory, were obtained at baseline, three, and six months; the comparison of depression scores between groups and over time from baseline to 3 and 6 months was considered as a secondary outcome and analyzed using repeated measures multivariate analysis of variance (MANOVA). Scores on the inventory range from 0 to 63, with higher scores indicating greater presence of depressive symptoms. Scores from 0-10 represent normal mood; 11-16 = mild mood disturbance; 17-20 = borderline clinical depression; 21-30 = moderate depression; 31-40 = severe depression; > 40 = extreme depression.|baseline to 6 months|||units on a scale||Standard Deviation|Mean
654308|NCT01966926|Primary|Adherence to Weight Tracking Instructions|Participants were assigned to daily or weekly weight tracking, and were asked to return postcards once a week with weights recorded (7 for daily, 1 for weekly).|6 months|All participants were included in the analysis.||percentage of postcards returned|||Number
654309|NCT01966770|Primary|Overall Ease of Lens Handling (Day 2 Study Lenses)|Participant rating of overall lens handling regarding insertion and removal. Collected at post-removal for each lens on Day 2. (0-100, 0=very difficult, 100=very easy|Day 2 - After Removal|||units on a scale||Standard Deviation|Mean
654310|NCT01966770|Primary|Overall Ease of Lens Handling (Day 1 Study Lenses)|Participant rating of overall lens handling regarding insertion and removal. Collected at post-removal for each lens on Day 1. (0-100, 0=very difficult, 100=very easy|Day 1 - After Removal|||units on a scale||Standard Deviation|Mean
654311|NCT01966770|Primary|Investigator Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 3)|Investigator rating of fit preference upon contact lens settling of pair 3. Collected at 30 minutes post settling for each lens. Percent of investigators that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strong R, Slight R, No Pref, Slight L, Strong L)|Day 2 - Insertion|||percentage of investigators|||Number
654312|NCT01966770|Primary|Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 2)|Investigator rating of fit preference upon contact lens settling of pair 2. Collected at 30 minutes post settling for each lens. Percent of investigators that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strong R, Slight R, No Pref, Slight L, Strong L)|Day 2 - Insertion|||percentage of investigators|||Number
654314|NCT01966770|Primary|Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 3)|Investigator rating of fit preference upon contact lens settling of pair 3. Collected at 30 minutes post settling for each lens. Percent of investigators that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strong R, Slight R, No Pref, Slight L, Strong L)|Day 1 - 30 minutes|||percentage of investigators|Participants||Number
654315|NCT01966770|Primary|Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 2)|Investigator rating of fit preference upon contact lens settling of pair 2. Collected at 30 minutes post settling for each lens. Percent of investigators that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strong R, Slight R, No Pref, Slight L, Strong L)|Day 1- 30 minutes|||percentage of investigators|Participants||Number
654316|NCT01966770|Primary|Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 1)|Investigator rating of fit preference upon contact lens settling of pair 1. Collected at 30 minutes post settling for each lens. Percent of investigators that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strong R, Slight R, No Pref, Slight L, Strong L)|Day 1- 30 minutes|||percentage of investigators|Participants||Number
654317|NCT01966770|Primary|Lens Fitting Characteristics, Upper Gaze Lag and Post-blink Movement (Day 2 Study Lenses)|Assessment of lens fitting characteristics. Collected at 30 minutes after lens settling of study lens.(Upgaze Lag and Post-blink Movement in mm)|Day 2 - 30 minutes|||millimeters|Participants|Standard Deviation|Mean
654318|NCT01966770|Primary|Lens Fitting Characteristics, Push-up Tightness (Day 2 Study Lenses)|Assessment of lens fitting characteristics. Collected at 30 minutes after lens settling of study lens. Digital push up test. (Continuous scale 0-100%, 0%=falls from cornea without lid support, 50%=optimum, 100%=no movement)|Day 2 - 30 minutes|||percentage|Participants|Standard Deviation|Mean
654319|NCT01966770|Primary|Lens Fitting Characteristics, Centration (Day 2 Study Lenses)|Assessment of lens fitting characteristics for the percentage of lenses with optimal centration. Collected at 30 minutes after lens settling of study lens. (Optimal Centration for Right and Left eyes; Optimum, Decentration Acceptable, Decentration unacceptable)|Day 2 - 30 minutes|||percentage of lenses|Participants||Number
654320|NCT01966770|Primary|Lens Fitting Characteristics, Upper Gaze Lag and Post-blink Movement (Day 1 - Study Lenses)|Assessment of lens fitting characteristics. Collected at 30 minutes after lens settling of study lens. (Upgaze Lag and Post-blink Movement in mm)|Day 1 - 30 minutes|||millimeter|Participants|Standard Deviation|Mean
654321|NCT01966770|Primary|Lens Fitting Characteristics, Push-up Tightness (Day 1 Study Lenses)|Assessment of lens fitting characteristics. Collected at 30 minutes after lens settling of study lens. Digital push up test. (Continuous scale 0-100%, 0%=falls from cornea without lid support, 50%=optimum, 100%=no movement)|Day 1 - 30 minutes|||percentage|Participants|Standard Deviation|Mean
654322|NCT01966770|Primary|Lens Fitting Characteristics, Centration (Day 1 Study Lenses)|Assessment of lens fitting characteristics for the percentage of lenses with optimal centration. Collected at 30 minutes after lens settling of study lens. (Optimal Centration for Right and Left eyes; Optimum, Decentration Acceptable, Decentration unacceptable)|Day 1 - 30 minutes|||percentage of lenses|Participants||Number
654323|NCT01966770|Primary|Lens Fitting Characteristics, Upgaze Lag and Post-blink Movement (Habitual Lens)|Assessment of habitual lens fitting characteristics. Collected at baseline with subject wearing habitual lens prior to dispense of study lens.(Upgaze Lag and Post-blink Movement in mm)|Baseline|||millimeters|Participants|Standard Deviation|Mean
654324|NCT01966770|Primary|Lens Fitting Characteristics, Tightness (Habitual Lens)|Assessment of habitual lens fitting characteristics. Collected at baseline with subject wearing habitual lens prior to dispense of study lens. Digital push up test. (Continuous scale 0-100%, 0%=falls from cornea without lid support, 50%=optimum, 100%=no movement)|Baseline|||percentage|Participants|Standard Deviation|Mean
654325|NCT01966770|Primary|Lens Fitting Characteristics, Centration (Habitual Lens)|Assessment of habitual lens fitting characteristics for the percentage of lenses with optimal centration. Collected at baseline with subject wearing habitual lens prior to dispense of study lens. (Optimal Centration for Right and Left eyes; Optimum, Decentration Acceptable, Decentration unacceptable)|Baseline|||percentage of eyes|Participants||Number
654326|NCT01966770|Primary|Comfort Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 3)|Participant rating of comfort preference upon contact lens settling of pair 3. Collected at 30 minutes post settling for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly prefer Left, No Preference, Slightly prefer Right, Strongly prefer Right)|Day 2 - 30 minutes|||percentage of participants|||Number
654327|NCT01966770|Primary|Comfort Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 2)|Participant rating of comfort preference upon contact lens settling of pair 2. Collected at 30 minutes post settling for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly prefer Left, No Preference, Slightly prefer Right, Strongly prefer Right)|Day 2 - 30 minutes|||percentage of participants|||Number
654328|NCT01966770|Primary|Comfort Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 1)|Participant rating of comfort preference upon contact lens settling of pair 1. Collected at 30 minutes post settling for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)|Day 2 - 30 minutes|||percentage of participants|||Number
654329|NCT01966770|Primary|Comfort Preference Contact Lens Insertion (Day 2 Study Lenses - Pair 3)|Participant rating of comfort preference upon contact lens insertion of pair 3. Collected at insertion for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)|Day 2 - Insertion|||percentage of participants|||Number
654330|NCT01966770|Primary|Comfort Preference Contact Lens Insertion (Day 2 Study Lenses - Pair 2)|Participant rating of comfort preference upon contact lens insertion of pair 2. Collected at insertion for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)|Day 2 - Insertion|||percentage of participants|||Number
654331|NCT01966770|Primary|Comfort Preference Contact Lens Insertion (Day 2 Study Lenses - Pair 1)|Participant rating of comfort preference upon contact lens insertion of pair 1. Collected at insertion for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)|Day 2 - Insertion|||percentage of participants|||Number
654332|NCT01966770|Primary|Comfort Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 3)|Participant rating of comfort preference upon contact lens settling of pair 3. Collected at 30 minutes post settling for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)|Day 1 - 30 minutes|||percentage of participants|||Number
654333|NCT01966770|Primary|Comfort Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 2)|Participant rating of comfort preference upon contact lens settling of pair 2. Collected at 30 minutes post settling for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)|Day 1 - 30 minutes|||percentage of participants|||Number
654334|NCT01966770|Primary|Comfort Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 1)|Participant rating of comfort preference upon contact lens settling of pair 1. Collected at 30 minutes post settling for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)|Day 1 - 30 minutes|||percentage of participants|||Number
654335|NCT01966770|Primary|Comfort Preference Contact Lens Insertion (Day 1 Study Lenses - Pair 3)|Participant rating of comfort preference upon contact lens insertion of pair 3. Collected at insertion for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)|Day 1 - Insertion|||percentage of participants|||Number
654336|NCT01966770|Primary|Comfort Preference Contact Lens Insertion (Day 1 Study Lenses - Pair 2)|Participant rating of comfort preference upon contact lens insertion of pair 2. Collected at insertion for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)|Day 1 Insertion|||percentage of participants|||Number
654337|NCT01966770|Primary|Comfort Preference Contact Lens Insertion (Day 1 Study Lenses - Pair 1)|Participant rating of comfort preference upon contact lens insertion of pair 1. Collected at insertion for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)|Day 1 - Insertion|||percentage of participants|||Number
654338|NCT01966770|Primary|Comfort Contact Lens 30 Minutes Wear (Day 2 Study Lenses)|Participant rating of comfort upon contact lens insertion. Collected after 30 minutes of wear at Day 2 for each lens . (0-100, 0=cannot be be worn causes pain, 100=cannot be felt ever|Day 2 - 30 minutes|||units on a scale||Standard Deviation|Mean
654339|NCT01966770|Primary|Comfort Contact Lens Insertion (Day 2 Study Lenses)|Participant rating of comfort upon contact lens insertion. Collected after insertion at Day 2 for each lens . (0-100, 0=cannot be worn causes pain, 100=cannot be felt ever|Day 2 - Insertion|||units on a scale||Standard Deviation|Mean
654340|NCT01966770|Primary|Comfort Contact Lens 30 Minutes Wear (Day 1 Study Lenses)|Participant rating of comfort after contact lens settling. Collected at 30 minutes wear for each lens. (0-100, 0=cannot be worn causes pain, 100=cannot be felt ever)|Day 1 - 30 minutes|||units on a scale||Standard Deviation|Mean
654341|NCT01966770|Primary|Comfort Contact Lens Insertion (Day 1 Study Lenses)|Participant rating of comfort upon contact lens insertion. Collected after insertion at Day 1 for each lens . (0-100, 0=cannot be worn causes pain, 100=cannot be felt ever)|Day 1 - Insertion|||units on a scale||Standard Deviation|Mean
654342|NCT01966770|Primary|Visual Acuity (VA) logMAR (Study Lenses)|Assessment of high contrast distance visual acuity (VA). Collected at dispense of study lens. (logMAR)|Dispense|||LogMAR||Standard Deviation|Mean
654343|NCT01966770|Primary|Visual Acuity (VA) logMAR (Habitual Lenses)|Assessment of high contrast distance visual acuity (VA). Collected at baseline with subject wearing habitual lens prior to dispense of study lens. (logMAR)|Baseline|||LogMar||Standard Deviation|Mean
654344|NCT01966718|Secondary|Change From Baseline in the C-Reactive Protein (CRP) Level|CRP was measured at Baseline and Week 16. Change was calculated by subtracting week 16 value from baseline value, with a positive value indicating a decrease from baseline.|From baseline to week 16|||mg/dL||Full Range|Mean
654345|NCT01966718|Secondary|Change From Baseline in the Erythrocyte Sedimentation Rate (ESR)|ESR was measured at baseline at week 16. Change was measured by subtracting week 16 score from baseline score. A positive number indicates that the ESR decreased|From baseline to week 16|||mm/hr||Full Range|Mean
654346|NCT01966718|Primary|Change From Baseline in the 20-item Health Assessment Questionnaire Score|"Subjects completed the Health Assessment Questionnaire, a 20-item scale that measures health-related quality of life. Participants are asked to rate activities on a scale from able to do with no difficulties to unable to do. A score of 0 indicates the participant has no problems performing daily activities, while a score of 3 indicates that the participant is completely disabled. Scores were calculated by subtracting score at week 16 from baseline score. A positive number indicates the score went down from baseline to week 16."|From baseline to week 16|||units on a scale||Full Range|Mean
654347|NCT01966718|Primary|Change From Baseline in the Ritchey-Camp Articular Index|Change in the Number of Joints that had Tenderness and/or Swelling According to the Ritchey-Camp Articular Index. Change was calculated using baseline and week 16 time points.|From baseline to week 16|||joints|Participants|Full Range|Mean
654348|NCT01966432|Primary|Treatment for Drug Use or Alcohol|Percentage of patients who received substance abuse or alcohol treatment (self reported)|Baseline, Six Month Follow-up|All subjects who completed the assessments were included.||percentage of participants||95% Confidence Interval|Number
655226|NCT01954160|Secondary|Glomerular Filtration Rate|Estimated Glomerular Filtration Rate (GFR) by creatinine and cystatin C|13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.|||||
654349|NCT01966432|Primary|Percentage of Participants Who Reported Substance Use at 6 Month|For SBI and SBIRT groups: Proportion of baseline substance users (SBI, SBIRT) who continue substance use during the study (self reported) For S group: Proportion of baseline non-users (S) who report substance use during follow-up visit|Baseline, Six Month Follow-up|All subjects who completed the assessments were included.||percentage of participants||95% Confidence Interval|Number
654350|NCT01966432|Primary|Alcohol Use Status|Results of AUDIT-C survey. The AUDIT-C is a 3-item alcohol screen that can help identify people who are hazardous drinkers or have active alcohol use disorders. AUDIT-C is scored on a scale of 0-12. The higher the score, the more likely it is that the person’s drinking is affecting his/her safety|Baseline, Six Month Follow-up|All subjects who completed the assessments were included.||units on a scale||95% Confidence Interval|Mean
654351|NCT01966432|Primary|Cigarette Smoking Status and Nicotine Dependence|Results from Fagerstrom Test for Nicotine Dependence. The Fagerström Test for Nicotine Dependence is a standard instrument for assessing the intensity of physical addiction to nicotine. It contains six items that evaluate the quantity of cigarette consumption, the compulsion to use, and dependence. The items are summed to yield a total score of 0-10. The higher the total Fagerström score, the more intense is the patient's physical dependence on nicotine.|Baseline, Six Month Follow-up|All subjects who completed the assessments were included.||units on a scale||95% Confidence Interval|Mean
654352|NCT01966432|Primary|Drug Use Status and Frequency|Results of DAST-10 survey to determine use of illicit or nonmedical drugs.The Drug Abuse Screening Test (DAST-10) is a 10-item brief screening tool that assesses drug use, not including alcohol or tobacco use, in the past 12 months. Each question requires a yes or no response, and the tool can be completed in less than 8 minutes. DAST-10 scores on a 10-point scale. A score of 0 indicates no problems and 10 indicates a severe level of problems are associated with drug abuse.|Baseline, Six Month Follow-up|All subjects who completed the assessments were included.||units on a scale||95% Confidence Interval|Mean
654353|NCT01966380|Primary|Absorption of Wound Exudates.|Absorption capacity measured subjectively: NA/POOR/GOOD/VERY GOOD/EXCELLENT|2-3 weeks|Participants served as their own controll, those the total amount of participants is reflekted in both of the outcome measurements.||Total no. assess. in each wounddressing|Participants||Number
654354|NCT01966354|Secondary|Infectious Complications|The incidence of bacterial catheter colonization and catheter-related blood stream infection will be registered once the central venous catheter has been withdrawn. Patients will be followed for the duration of central venous access, an expected average of 8 weeks. The number of patients with bacterial colonization and catheter-related blood stream infection will be registered.|Once the central venous catheter is withdrawn (2 months)|||participants|||Number
654355|NCT01966354|Secondary|Mechanical Complications|The incidence of the following mechanical complications will be registered: number of patients with accidental arterial puncture, number of patients with puncture site bleeding, number of patients with puncture site haematoma, number of patients with pneumothorax, number of patients catheter tip misplacement. This outcome measure will be registered at the end of the cannulation process, and once a control chest x-Ray has been performed.|At the end of the cannulation process (180 seconds, maximum)|||participants|||Number
654356|NCT01966354|Secondary|Cannulation Time|Time elapsed (seconds) from the moment the Seldinger needle pierces the skin to the moment the guidewire is inserted inside the vein. This outcome measure will be registered at the end of the cannulation process.|At the end of the cannulation process (180 seconds, maximum)|||seconds||Standard Deviation|Mean
654357|NCT01966354|Secondary|First Attempt Cannulation|"Any cannulation that has been accomplished with a single cannulation attempt will be considered a first attempt cannulation. This outcome measure will be registered at the end of the cannulation process."|At the end of the cannulation process (180 seconds, maximum)|||participants|||Number
654358|NCT01966354|Secondary|Number of Cannulation Attempts|Number of cannulation attempts that have taken place before cannulation success. Any withdrawal of the needle followed by an advance will be considered a separated cannulation attempt.This outcome measure will be registered at the end of the cannulation process.|At the end of the cannulation process (180 seconds, maximum)|||attempts||Standard Deviation|Mean
654359|NCT01966354|Primary|Cannulation Success|"Cannulation will be considered as successful once a flexible guidewire has been inserted into the internal jugular vein during the first 180 seconds from the moment the Seldinger needle pierces the skin. If time spent until guidewire insertion is more than 180 seconds, or if guidewire cannot be inserted into the internal jugular vein chosen, cannulation will be considered unsuccessful. This outcome measure will be registered at the end of the cannulation process."|At the end of the cannulation process (180 seconds, maximum)|||participants|||Number
654360|NCT01966159|Other Pre-specified|Target Lesion Failure (TLF) Rate|Target lesion failure is any ischemia-driven revascularization of the target lesion, MI (Q-wave and non–Q-wave) related to the target vessel, or (cardiac) death.|12 months post-index procedure|||percentage of participants|||Number
654361|NCT01966159|Secondary|Target Lesion Revascularization (TLR) Rate|Target lesion revascularization is any ischemia-driven repeat percutaneous intervention, to improve blood flow, of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.|12 months post-index procedure|||percentage of participants|||Number
654362|NCT01966159|Primary|The In-stent Late Loss Measured by Quantitative Coronary Angiography||at 9 months post-index procedure.|||mm||Standard Deviation|Mean
654363|NCT01966120|Primary|Overall Patient Complete Response 12 Weeks After the Last PDT (PP)|"All efficacy variables were evaluated for the FAS. The primary efficacy variable was also analyzed for the PP population. All subgroup analyses were carried out for the FAS. Data for size and grade of AK lesions were analyzed using the last observation carried forward (LOCF) approach, affecting the response rates evaluation.
Due to the small amount of missing data in the study, which did not have any relevant impact on primary results, sensitivity analyses for missing data were not performed.
The primary efficacy variable was the overall patient complete response 12 weeks after the last PDT. An overall complete responder was defined as a patient in whom all treated AK lesions were cleared (Olsen score of 0) after the last PDT, i.e. after PDT 1 or after PDT 2 if re-treatment was performed."|12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT|Per Protocol Set (PP)||percentage of participants||95% Confidence Interval|Number
673865|NCT01657292|Secondary|Time From Study Start After Burn Accident Until Wound Closure is Achieved Separately for Wound Halves Treated With Oleogel-S10 vs. Standard of Care||2 to 3 weeks||||||
654364|NCT01966120|Secondary|Overall Cosmetic Outcome 12 Weeks After Last PDT for Patients With Sum Score at Baseline of 1 to 3|"Study personnel assessed and recorded the skin quality of the treated field(s) at baseline and at the end-of-study visit including skin surface, hyperpigmentation, hypopigmentation, mottled or irregular pigmentation, degree of scarring and atrophy.
Upon visual examination of the treated field(s), the investigator coded the intensity of each skin parameter on a scale of 0 to 3, where 0 = none, 1 = mild, 2 = moderate, and 3 = severe.
The cosmetic outcome evaluations were based on the sum score of the skin quality assessment (sum of all ratings for each skin parameter) at the end-of-study visit (Visit 4 or Visit 6, if retreated).
The outcome was calculated using a 5-point scale ranging from “very good” (0) to “impaired” (4) based on the change of the skin quality assessments compared to baseline (0 = 2 points improvement; 1 = 1 point improvement; 2 = no change; 3 = 1 point worsened; 4 = at least 2 points worsened)."|12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT|Full Analysis Set (FAS)||percentage of participants||95% Confidence Interval|Number
654365|NCT01966120|Secondary|Overall Cosmetic Outcome 12 Weeks After Last PDT for Patients With Sum Score at Baseline of 0 to 3|"Study personnel assessed and recorded the skin quality of the treated field(s) at baseline and at the end-of-study visit including skin surface, hyperpigmentation, hypopigmentation, mottled or irregular pigmentation, degree of scarring and atrophy.
Upon visual examination of the treated field(s), the investigator coded the intensity of each skin parameter on a scale of 0 to 3, where 0 = none, 1 = mild, 2 = moderate, and 3 = severe.
The cosmetic outcome evaluations were based on the sum score of the skin quality assessment (sum of all ratings for each skin parameter) at the end-of-study visit (Visit 4 or Visit 6, if retreated).
The outcome was calculated using a 5-point scale ranging from “very good” (0) to “impaired” (4) based on the change of the skin quality assessments compared to baseline (0 = 2 points improvement; 1 = 1 point improvement; 2 = no change; 3 = 1 point worsened; 4 = at least 2 points worsened)."|12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT|Full Analysis Set (FAS)||percentage of participants||95% Confidence Interval|Number
654366|NCT01966120|Secondary|Change of Total Lesion Area 12 Weeks After Last PDT|The fifth key secondary efficacy variable in the hierarchic test procedure was the change from baseline in the total lesion area per patient assessed at 12 weeks after last PDT.|12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT|Full Analysis Set (FAS)||percentage of lesion area change||Standard Deviation|Mean
654367|NCT01966120|Secondary|Patient Partial Response 12 Weeks After Last PDT|The fourth key secondary efficacy variable in the hierarchic test procedure was the patient partial response (defined as complete clearance of at least 75% of treated AK lesions) assessed at 12 weeks after last PDT.|12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT|Full Analysis Set (FAS)||percentage of participants||95% Confidence Interval|Number
654368|NCT01966120|Secondary|Lesion Complete Response 12 Weeks After Last PDT|The third key secondary efficacy variable in the hierarchic test procedure was the lesion complete response (completely cleared individual AK lesions) assessed at 12 weeks after last PDT.|12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT|Full Analysis Set (FAS)||percentage of lesions|Number of Lesions Analyzed|95% Confidence Interval|Number
654369|NCT01966120|Secondary|Patient Complete Response 12 Weeks After PDT 1|The second key secondary efficacy variable in the hierarchic test procedure was the patient complete response (complete clearance of all treated AK lesions) assessed at 12 weeks after PDT 1.|12 weeks after PDT 1|Full Analysis Set (FAS)||percentage of participants||95% Confidence Interval|Number
654370|NCT01966120|Secondary|Patient Histopathological Confirmed Response Rate|"For the secondary confirmatory analysis, several superiority hypotheses were tested within a pre-defined hierarchic multiple testing procedure as described in the Statistical Analysis Protocoll (SAP).
The key secondary efficacy variables were tested strictly in a pre-defined order to ensure the family-wise error rate (FWER) and the testing procedure had to be stopped once the first non-significant test was obtained.
The results of the confirmatory analysis are presented in the order pre-defined by the confirmatory testing procedure.
Assessments of the patient histopathological confirmed response (HCR) rates were based on the results from the biopsy taken 12 weeks after the last PDT from a representative AK lesion selected at screening. If the biopsy result for a patient revealed a residual AK, the patient was considered “not cleared” for the analysis irrespectively of the investigator’s clinical assessment."|12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT|Full Analysis Set (FAS) 6 patients (1 BF-200 ALA and 5 Placebo patients) had a missing evaluation of the second biopsy 12 weeks after PDT.||percentage of participants||95% Confidence Interval|Number
654371|NCT01966120|Primary|Overall Patient Complete Response 12 Weeks After the Last Photodynamic Therapy (PDT)|"All efficacy variables were evaluated for the FAS. The primary efficacy variable was also analyzed for the PP population. All subgroup analyses were carried out for the FAS. Data for size and grade of AK lesions were analyzed using the last observation carried forward (LOCF) approach, affecting the response rates evaluation.
Due to the small amount of missing data in the study, which did not have any relevant impact on primary results, sensitivity analyses for missing data were not performed.
The primary efficacy variable was the overall patient complete response 12 weeks after the last PDT. An overall complete responder was defined as a patient in whom all treated actinic keratosis (AK) lesions were cleared (Olsen score of 0) after the last PDT, i.e. after PDT 1 or after PDT 2 if re-treatment was performed."|12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT|Full Analysis Set (FAS)||percentage of participants||95% Confidence Interval|Number
654372|NCT01966068|Primary|Difference Between Number of Families Who Adopted MyAsthma Portal Use and Number of Families With Sustained Use|Implementation success was measure by comparing the of the number of enrolled families (parent/guardian) who logged on to the MyAsthma Portal once (adoption) with the number of enrolled families (parent/guardian) who logged on more than once (sustained use). Parents/guardians were asked to log on and complete the same survey on the MyAsthma Portal 3 times during a 6 month period.|Up to 6 Months|Analysis population included every subject (parent/guardian) who logged on to the MyAsthma Web Portal at least once.||participants|||Number
673866|NCT01657292|Secondary|Intra-individual Difference in Time to Wound Closure Between Wound Halves, Either Treated With Oleogel-S10 or Treated With Standard of Care||2 to 3 weeks||||||
654374|NCT01966042|Other Pre-specified|Life Quality|"Analysis of the variation in life quality questionnaire - Short Form Health Survey (SF-36) was performed. Each domain of the questionnaire was evaluated as a quantitative variable and the medians were retrieved before and after the procedure.
The SF-36 is a multi-purpose, short-form health survey with only 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index.
It consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
One patient was lost before answering the questionnaire post procedure."|Baseline and 12 months|||units on a scale||Standard Deviation|Median
654375|NCT01966042|Secondary|Functional Change Evaluation|Analysis of Left Ventricular Ejection Fraction (in %), by echocardiogram.|Baseline and 12 months|||percentage of Left Ventrical Ejection||Standard Deviation|Median
654376|NCT01966042|Primary|Angina Class Variation|"It was evaluated in accordance with the percentage of participants that change the functional class of angina according to CCSAC (Canadian Cardiovascular Society Angina Classification - description below), after treatment. The functional class of angina was also analyzed as an ordinal variable and the median of the functional class was calculated before and after the procedure, at the time of interest (3, 6 and 12 months post treatment), in comparison to baseline, ie. value at 3 months minus value at baseline.
Screening of Functional Graduation of Stable Angina:
I - Angina only occurs after a fast or prolonged and strenuous effort during work or recreation.
II - Slight limitation to everyday activities. III - Considerable limitation of common physical activity. IV - Inability to perform any physical activity without discomfort, the symptoms can be present at rest."|3, 6 and 12 months|||Angina Classification||Standard Deviation|Median
654377|NCT01965938|Secondary|Alternate Device Used||<100 seconds|||number times an alternate device used|||Number
654378|NCT01965938|Other Pre-specified|Oropharyngeal Injuries|Number of patients with any notation of any trauma to lips, teeth, soft tissue, etc.|24 hours|||participants|||Number
654379|NCT01965938|Secondary|Lowest Pulse Oximetry Saturation Value Reading During Intubation|Lowest pulse oximetry saturation value reading collected from any participant during intubation|<100 seconds|||percentage of saturated hemoglobin|||Number
654380|NCT01965938|Secondary|Assistance Maneuvers, if Any, Provided by the Attending Anesthesiologist|Number of patients that required Assistance Maneuvers provided by the attending anesthesiologist such as jaw lift, tongue protrusion, laryngeal pressure, etc|<100 seconds|||participants|||Number
654381|NCT01965938|Secondary|Grade of Glottic View|According to McCormack and Lehane|<100 seconds|data was not collected|||||
654382|NCT01965938|Secondary|Number of Attempts Performed During Airway Management||<100 seconds|||number attempts||Standard Deviation|Mean
654383|NCT01965938|Secondary|Number of Participants With Successful Intubation|Successful intubation defined as confirming tube placement by the presence of etCO2;|<100 seconds|||participants|||Number
654384|NCT01965938|Primary|Time Until Proper Endotracheal Tube Placement|Time (in seconds) from first placement of the intubating scope in the oral cavity until proper endotracheal tube placement is confirmed by the presence of End Tidal Co2 (etCO2). Time to successful intubation was defined as the period from when the tip of the RIFL or FOB passed the incisors until withdrawal past that same point after successful intubation.|usually <100 seconds|||seconds||Inter-Quartile Range|Median
654385|NCT01965899|Secondary|Survey of the Patient Experience Over Time|"To understand the study subjects' experience with the Reveal LINQ, the patient assistant and the patient home monitor. Patient responses to survey questions will be characterized. Below we will summarize the responses to question Based on your experience to date, please rate your satisfaction with the Reveal LINQ device over 1 month, 6 month, and 12 month follow-up visit."|12 months|"There were 149 patient surveys from 150 1-month follow-up visits collected, 145 surveys from 147 6-month visits, and 143 surveys from 144 12-month visits. Thus, 437 surveys were collected from 441 follow-up visits. The question Based on your experience to date, please rate your satisfaction with the Reveal LINQ device was answered 434 times."||Percentage of surveys|Participants||Number
654386|NCT01965899|Secondary|Survey of the Implanting Physicians|"To understand the implanting physicians' experience with the implant of the Reveal LINQ, and the accompanying implanter tools. Responses to survey questions will be characterized. Below we summarize the responses to survey question Overall, how would you rate the ease of entire implant procedure?."|Day of implant|"There have been 151 implant procedures in the study, and 151 physician implant surveys were collected. Of these 151 surveys, 149 answered the question Overall, how would you rate the ease of entire implant procedure?."||Percentage of surveys|||Number
654387|NCT01965899|Secondary|Accuracy of Device Detected Atrial Fibrillation Compared to Holter Monitor|To compare the Reveal LINQ atrial fibrillation detection accuracy with atrial fibrillation detection from Holter monitoring. The true positive rate (sensitivity), specificity, positive predictive value and negative predictive value will be estimated using Holter recordings as the gold standard. Sensitivity measures the proportion of positives that are correctly identified as such. Specificity measures the proportion of negatives that are correctly identified as such. The positive and negative predictive values are the proportion of positive and negative detected patients that are true positive and true negative, respectively. Accuracy measures the proportion of all patients that are correctly identified as negative or positive.|48 hours|A Holter recording was performed in all 150 patients (one patient exited before 1 month), of which 141 were suitable for analysis after excluding recordings with technical issues, such as loss of telemetry or inability to process the data.||Percentage of patients|||Number
654388|NCT01965899|Secondary|Safety Endpoint|To characterize the system-related and procedure-related adverse events.|12 months|||Number of events|||Number
654389|NCT01965899|Secondary|Accuracy of Reveal LINQ Device Detected Atrial Fibrillation|To assess atrial fibrillation detection by the Reveal LINQ insertable cardiac monitor (ICM). True and false positives will be reported.|4 months|||Episodes|Participants||Number
654390|NCT01965899|Primary|R-wave Amplitudes Greater Than or Equal to 200 μV|The proportion of R-wave amplitudes that are greater than or equal to 200 μV will be estimated at implant and one month.|30 days|For each subject implanted with a Reveal LINQ device an R-wave amplitude measurement is collected at implant and 1 month follow-up.||Percentage of subjects|||Number
654393|NCT01965834|Secondary|Proportion of Participants Achieving Progression-Free Survival|Proportion of participants achieving progression-free survival. Measured from date of initiation of treatment (Day 1) to the earliest occurrence of any of the following events: documented disease progression, or death from any cause. Patients who are alive and progression-free will be censored at the date of last documented progression-free status.|6 months, 12 months|||participants|||Number
654394|NCT01965834|Secondary|Number of Subjects Experiencing Adverse Events|To evaluate safety and tolerability of fenofibrate therapy in patients with multiple myeloma.|Up to 8 months|||participants|||Number
654395|NCT01965834|Primary|Rate of Response in Participants Receiving Fenofibrate Therapy|To determine response rate (Strict Complete Response (sCR), Complete response (CR), Very Good Partial Response (VgPR), and Partial Response (PR)) in multiple myeloma patients receiving oral fenofibrate therapy. Response will be measured by serum and urine protein electrophoresis and immunofixation, as well as by percentage of plasma cells present on bone marrow biopsy.|After two cycles, about 2 months|No participants achieved response to protocol therapy (Strict Complete Response (sCR), Complete response (CR), Very Good Partial Response (VgPR), or Partial Response (PR)). Two (2) patients had stable disease (SD); one (1) patient achieved Stable Disease/clinical Progressive Disease, and three (3) patients had progressive disease (PD).||participants|||Number
654396|NCT01965756|Other Pre-specified|Cerebrospinal Fluid Phosphorylated Tau Concentration||baseline and 8 weeks|CSF was only collected from all participants at baseline and again at week 8 (total of two lumbar punctures). This was pre-specified in the protocol, to ensure adequate tolerability for subjects (total of two lumbar punctures, rather than three). Thus, there is a maximum of 10 data points for each category: 10 for MET-->PBO, and 10 for PBO-->MET||pg/mL||Standard Deviation|Mean
654397|NCT01965756|Other Pre-specified|Cerebrospinal Fluid Total Tau Concentration||baseline and 8 weeks|CSF was only collected from all participants at baseline and again at week 8 (total of two lumbar punctures). This was pre-specified in the protocol, to ensure adequate tolerability for subjects (total of two lumbar punctures, rather than three). Thus, there is a maximum of 10 data points for each category: 10 for MET-->PBO, and 10 for PBO-->MET||pg/mL||Standard Deviation|Mean
654398|NCT01965756|Other Pre-specified|Cerebrospinal Fluid Amyloid Beta Concentration||baseline and 8 weeks|CSF was only collected from all participants at baseline and again at week 8 (total of two lumbar punctures). This was pre-specified in the protocol, to ensure adequate tolerability for subjects (total of two lumbar punctures, rather than three). Thus, there is a maximum of 10 data points for each category: 10 for MET-->PBO, and 10 for PBO-->MET||pg/mL||Standard Deviation|Mean
654399|NCT01965756|Secondary|Trails-B|Standard Trails-B assessment, in which subject is asked to begin at Number 1 and draw a line to Letter A, then to Number 2, then to Letter B, then so forth until he/she reaches the END, without lifting their pencil. They should draw the line as fast as possible, and are timed (in seconds).|16 weeks- measured at baseline, week 8 (crossover), and week 16|||Seconds||Standard Deviation|Mean
654400|NCT01965756|Primary|Word List Memory Total - ADAS-cog|Alzheimer's Disease Assessment Scale- Cognitive Sub scale (ADAS-COG). Three trials of 10 words each (30 words total)|16 weeks (total) - measured at baseline, week 8 (crossover), and week 16|||Words recalled||Standard Deviation|Mean
654401|NCT01965665|Primary|Change in Sepsis Rate|Patients will be assessed weekly for sepsis or until frame is removed.|weekly from baseline until frame removal, up to 16 weeks|Data not collected|||||
654402|NCT01965665|Primary|Number of Patients With Pin Site Infection|Patients will be assessed weekly for pin site infection up until frame removal.|weekly from baseline until frame removal, up to 16 weeks|||participants|||Number
654403|NCT01965665|Primary|Total Number of Pin Sites|total number of pin sites for all patients enrolled|Day of surgical intervention approximately 3hrs.|||total number of pin sites|||Number
654404|NCT01965652|Secondary|Participant Global Satisfaction|"Participants were asked to rate their degree of satisfaction of constipation and abdominal symptoms from the start of study drug dosing to Week 52 (or early termination).
Satisfaction was rated based on the following seven grades:
Grade 1 = markedly worsened
Grade 2 = moderately worsened
Grade 3 = slightly worsened
Grade 4 = unchanged
Grade 5 = slightly improved
Grade 6 = moderately improved
Grade 7 = markedly improved"|Week 52 or early termination visit|Intent-to-treat population||percentage of participants|||Number
654405|NCT01965652|Secondary|Change From Baseline in the Satisfaction Domain of PAC-QOL|"The Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL) consists of 28 questions designed to measure the impact constipation has had on participants’ daily life during the past 2 weeks.
Each question was evaluated by the participant on a five-point scale ranging from 0 (not at all or none of the time) to 4 (extremely or all of the time), where higher scores represent poorer quality of life. The satisfaction domain consists of 5 questions related to participants’ feelings of satisfaction with their bowel function. The satisfaction domain score was calculated as the mean of the 5 individual scores. A negative change from baseline value indicates improvement."|Baseline and Weeks 2, 12, 24, 36, and 52|Intent-to-treat population||units on a scale||Standard Error|Least Squares Mean
654406|NCT01965652|Secondary|Change From Baseline in the Worries and Concerns Domain of PAC-QOL|"The Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL) consists of 28 questions designed to measure the impact constipation has had on participants’ daily life during the past 2 weeks.
Each question was evaluated by the participant on a five-point scale ranging from 0 (not at all or none of the time) to 4 (extremely or all of the time), where higher scores represent poorer quality of life. The worries and concerns domain consists of 11 questions related to participants’ feelings and concerns about their constipation. The worries and concerns domain score was calculated as the mean of the 11 individual scores. A negative change from baseline value indicates improvement."|Baseline and Weeks 2, 12, 24, 36, and 52|Intent-to-treat population||units on a scale||Standard Error|Least Squares Mean
654427|NCT01965600|Primary|MPO Activity (Area Under the Concentration-time Profile From 0 to 2 Hours [AUC0-2hrs]) Following Inflammatory Stimulus|MPO is a heme-containing peroxidase enzyme produced in the bone marrow and stored in the azurophilic granules of neutrophils, where it constitutes up to 5% of the cellular protein. Since PF-06282999 is a mechanism-based inactivator of MPO, it is of interest to evaluate the level of MPO activity in order to investigate the inhibition activity of PF-06282999.|Days 1, 3-5|Due to early termination of the study, there was not enough participants to perform meaningful analysis on this endpoint. As such, no analysis was done.|||||
674020|NCT01656252|Secondary|Phase II- Time to Platelet Count Recovery|To determine the impact of eltrombopag on time to platelet recovery following consolidation chemotherapy.|62 months||||||
654407|NCT01965652|Secondary|Change From Baseline in the Psychosocial Discomfort Domain of PAC-QOL|"The Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL) consists of 28 questions designed to measure the impact constipation has had on participants’ daily life during the past 2 weeks.
Each question was evaluated by the participant on a five-point scale ranging from 0 (not at all or none of the time) to 4 (extremely or all of the time), where higher scores represent poorer quality of life. The psychosocial discomfort domain consists of 8 questions related to participants’ embarrassment regarding their constipation and effects of constipation on eating habits and appetite.
The psychosocial discomfort score was calculated as the mean of the 8 individual scores. A negative change from baseline value indicates improvement."|Baseline and Weeks 2, 12, 24, 36, and 52|Intent-to-treat population||units on a scale||Standard Error|Least Squares Mean
654408|NCT01965652|Secondary|Change From Baseline in the Physical Discomfort Domain of PAC-QOL|"The Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL) consists of 28 questions designed to measure the impact constipation has had on participants’ daily life during the past 2 weeks.
Each question was evaluated by the participant on a five-point scale ranging from 0 (not at all or none of the time) to 4 (extremely or all of the time), where higher scores represent poorer quality of life. The physical discomfort domain consists of 4 questions related to bloating, feeling heavy, how much of the time participants felt any physical discomfort and how much time they felt the need to open their bowel but were not able to. The physical discomfort score was calculated as the mean of the 4 individual scores. A negative change from baseline value indicates improvement."|Baseline and Weeks 2, 12, 24, 36, and 52|Intent-to-treat population||units on a scale||Standard Error|Least Squares Mean
654409|NCT01965652|Secondary|Change From Baseline in the Patient Assessment of Constipation Quality of Life Overall Score|"The Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL) consists of 28 questions designed to measure the impact constipation has had on participants’ daily life during the past 2 weeks.
Each question was evaluated by the participant on a five-point scale ranging from 0 (not at all or none of the time) to 4 (extremely or all of the time), where higher scores represent poorer quality of life. The overall score was calculated as the mean of all 28 item scores. A negative change from baseline value indicates improvement."|Baseline and Weeks 2, 12, 24, 36, and 52|Intent-to-treat||units on a scale||Standard Error|Least Squares Mean
654410|NCT01965652|Secondary|Change From Baseline in the PAC-SYM Stool-symptoms Domain Score|"The Patient Assessment of Constipation Symptom Questionnaire (PAC-SYM) asked participants to rate the severity of 12 constipation symptoms in the last 2 weeks on a scale from 0 (absent) to 4 (very severe). The stool-symptom domain score was calculated as the mean of the following 5 items: incomplete bowel movements, bowel movements that were too hard, bowel movements that were too small, straining or squeezing to try to pass bowel movements, and false-alarm bowel movements.
A negative change from baseline value indicates improvement in symptoms."|Baseline and Weeks 2, 12, 24, 36, and 52|Intent-to-treat population||units on a scale||Standard Error|Least Squares Mean
654411|NCT01965652|Secondary|Change From Baseline in the PAC-SYM Rectal-symptoms Domain Score|The Patient Assessment of Constipation Symptom Questionnaire (PAC-SYM) asked participants to rate the severity of 12 constipation symptoms in the last 2 weeks on a scale from 0 (absent) to 4 (very severe). The abdominal-symptom domain score was calculated as the mean of the following 3 items: painful bowel movements, rectal burning during or after a bowel movement, and rectal bleeding or tearing during or after a bowel movement. A negative change from baseline value indicates improvement in symptoms.|Baseline and Weeks 2, 12, 24, 36, and 52|Intent-to-treat population||units on a scale||Standard Error|Least Squares Mean
654412|NCT01965652|Secondary|Change From Baseline in the PAC-SYM Abdominal-symptoms Domain Score|"The Patient Assessment of Constipation Symptom Questionnaire (PAC-SYM) asked participants to rate the severity of 12 constipation symptoms in the last 2 weeks on a scale from 0 (absent) to 4 (very severe). The abdominal-symptom domain score was calculated as the mean of the following 4 items: abdominal discomfort, abdominal pain, abdominal bloating and stomach cramps.
A negative change from baseline value indicates improvement in symptoms."|Baseline and Weeks 2, 12, 24, 36, and 52|Intent-to-treat population||units on a scale||Standard Error|Least Squares Mean
654413|NCT01965652|Secondary|Change From Baseline in the Overall Score for Patient Assessment of Constipation Symptoms|The Patient Assessment of Constipation Symptom Questionnaire (PAC-SYM) asked participants to rate the severity of 12 constipation symptoms in the last 2 weeks on a scale from 0 (absent) to 4 (very severe). The overall score was calculated as the mean of all 12 items and ranges from 0 (best) to 4 (worst). A negative change from baseline value indicates improvement.|Baseline and Weeks 2, 12, 24, 36, and 52|The intent-to-treat population includes all randomized participants. Five participants were excluded due to double enrollment at different sites.||units on a scale||Standard Error|Least Squares Mean
654414|NCT01965652|Secondary|Percentage of Participants Meeting Each Criterion of Laxative Use|"Participants who were taking stable routine/regular laxatives at Screening were to continue taking the same regimen throughout the study.
The percentage of participants meeting each of the criteria below are reported:
1. Participants not on stable laxatives, defined as participants who did not use laxatives from 28 days prior to the Screening Period to the final dose of study drug or who received only rescue laxative. Rescue is defined as any laxative taken for the first time during the Treatment Period.
1a. Out of participants who were not on stable laxatives, participants who received rescue laxatives.
2. Participants on stable laxatives, defined as participants who may have had at least one/any stable laxative use reported from 28 days prior to Screening Period to the final dose of study drug.
2a. Out of participants who were on stable laxatives, participants who received rescue laxatives.
3. Participants who did not meet criteria 1 or 2."|From 28 days prior to screening until the end of the treatment period (total of 56 weeks)|Intent-to-treat population||percentage of participants|||Number
654415|NCT01965652|Secondary|Change From Baseline in the Number of Bowel Movements Per Week|Participants monitored their bowel movements and completed a daily bowel habits diary the week prior to study visits (i.e. during Weeks 11, 23, 35, and 51).|Baseline and Weeks 12, 24, 36, and 52|The intent-to-treat population includes all randomized participants. Five participants were excluded due to double enrollment at different sites.||bowel movements / week||Standard Error|Least Squares Mean
654456|NCT01965288|Primary|Overall Fit Acceptance|Assessment of Lens Fit Performance for overall lens fit acceptance. Collected at 4 weeks for each lens. Rated perfect or not perfect based on lens fit alone. (0-4; 0=should not be worn, 3=not perfect but OK to dispense, 4=perfect)|4 weeks|All 60 subjects randomized to both sets of lenses.||percentage of lenses|Participants||Number
654416|NCT01965652|Primary|Number of Participants With Adverse Events|"A serious adverse event was defined as any adverse event (AE) that resulted in any of the following outcomes: death, life-threatening AE, hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life threatening, or require hospitalization were considered an SAE when, based upon appropriate medical judgment, they jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above.
Adverse drug reactions (ADRs) were defined as adverse events that were considered by the investigator to be definitely, probably, or possibly related to study drug. Serious ADRs were defined as serious AEs considered by the investigator to be definitely, probably, or possibly related to study drug."|From the first dose of study drug up to 14 days after the last dose of study drug (54 weeks).|Safety population||participants|||Number
654417|NCT01965600|Secondary|Time to Cmax (Tmax) of PF-06282999||Day 3|Due to early termination of the study, no data was collected for this endpoint.|||||
654418|NCT01965600|Secondary|Area Under the Concentration-time Profile From Time 0 to End of Dosing Interval, Tau (AUCtau) of PF-06282999||Day 3|Due to early termination of the study, no data was collected for this endpoint.|||||
654419|NCT01965600|Secondary|Maximum Plasma Concentration (Cmax) of PF-06282999||Day 3|Due to early termination of the study, there was not enough participants to perform meaningful analysis on this endpoint. As such, no analysis was done.|||||
654420|NCT01965600|Secondary|Peak (AUC0.5-2hours and AUC0-2hours) of MPO Activity/MPO Mass|MPO is a heme-containing peroxidase enzyme produced in the bone marrow and stored in the azurophilic granules of neutrophils, where it constitutes up to 5% of the cellular protein. Since PF-06282999 is a mechanism-based inactivator of MPO, it is of interest to evaluate the level of MPO activity in order to investigate the inhibition activity of PF-06282999.|Days 1, 3-5|Due to early termination of the study, there was not enough participants to perform meaningful analysis on this endpoint. As such, no analysis was done.|||||
654421|NCT01965600|Secondary|Concentrations of TNF-alpha, IL-1 Beta, IL-6, IL-8, and hsCRP|The effect of multiple oral doses of PF-06282999 on inflammatory biomarkers was a secondary objective in this study. The biomarkers are tumor necrosis factor (TNF)-alpha, interleukin (IL)-1 beta, IL-6, IL-8, and high-sensitivity C-reactive protein (hsCRP).|Days 1, 3, and 4|Due to early termination of the study, there was not enough participants to perform meaningful analysis on this endpoint. As such, no analysis was done.|||||
654422|NCT01965600|Primary|Number of Participants With Abnormal Urinary Biomarker Values|Urinary biomarkers included albumin, neutrophil gelatinase-associated lipocalin (NGAL) and Cystatin-C.|Days 1-3 prior to dosing with PF-06282999/Placebo; and Days 4-5|Analysis not done due to early termination of study.|||||
654423|NCT01965600|Primary|Number of Participants With Electrocardiogram (ECG) Values Meeting Categorical Summarization Criteria|Criteria for ECG (12-lead) values meeting categorical summarization criteria were: the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization (PR interval >=300 milliseconds (msec) and increase from baseline >=25/50%; time from the beginning of the ECG Q wave to the end of the S wave corresponding to ventricular depolarization (QRS) interval >=140 msec and increase of >=50%; the beginning of the Q wave to the end of the T wave corresponding to electrical systole (QT) interval >=500 msec; QT corrected using the Fridericia formula (QTcF) of 450 to <480 msec, 480 to <500 msec, and >=500 msec, or an increase of 30 to <60 msec or >=60 msec. Due to early termination of the study, only ECG data from partial enrollment are reflected and comparisons between treatment arms should not be attempted.|Screening; Days 1-5 and approximately 7-10 days following the last dose of PF-06282999/Placebo in Period 2|All participants who received at least 1 dose of study medication (including LPS) were included in the safety analyses and listings.||participants|||Number
654424|NCT01965600|Primary|Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria|Categorical summarization criteria in vital signs included: sitting, supine, and standing systolic blood pressure (SBP) of less than (<)90 millimeters of mercury (mm Hg) or change (increase [inc] or decrease [dec]) in sitting, supine and standing SBP of more than or equal to (>=)30 mm Hg; supine, sitting, and standing diastolic blood pressure (DBP) of <50 mm Hg or change (inc or dec) in sitting, supine, and standing DBP of >=20 mm Hg; supine and sitting pulse rate (PR) of <40 or more than (>)120 beats per minute (bpm); and standing PR of <40 or >140 bpm. Due to early termination of the study, only vital signs data from partial enrollment are reflected and comparisons between treatment arms should not be attempted.|Screening and Days 1-2, 4-5, and approximately 7-10 days following the last dose of PF-06282999/Placebo in Period 2 for orthostatic (orth) measurements; Day 3 for supine measurements|All participants who received at least 1 dose of study medication (including LPS) were included in the safety analyses and listings. n=number of participants evaluable for that parameter||participants|||Number
654425|NCT01965600|Primary|Number of Participants With Laboratory Test Abnormalities|Number of participants with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters included hematology, coagulation, liver function, renal function, electrolytes, clinical chemistry, and urinalysis (dipstick and microscopy). Due to early termination of the study, only laboratory data from partial enrollment are reflected and comparisons between treatment arms should not be attempted.|Baseline up to 7-10 days following the last dose of PF-06282999/Placebo in Period 2|All participants who received at least 1 dose of study medication (including LPS) were included in the safety analyses and listings.||participants|||Number
654426|NCT01965600|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs|An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs comprised both SAEs and non-SAEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were defined as newly occurring AEs or those worsening after first dose. Due to early termination of the study, only AE data from partial enrollment are reflected and comparisons between treatment arms should not be attempted.|From Day 0 till approximately 7-10 days following the last dose of PF-06282999/Placebo in Period 2 (up to approximately 2 months)|All participants who received at least 1 dose of study medication (including LPS) were included in the safety analyses and listings.||participants|||Number
654428|NCT01965600|Primary|MPO Activity (Area Under the Concentration-time Profile From 0.5 to 2 Hours [AUC0.5-2hrs]) Following Inflammatory Stimulus|MPO is a heme-containing peroxidase enzyme produced in the bone marrow and stored in the azurophilic granules of neutrophils, where it constitutes up to 5% of the cellular protein. Since PF-06282999 is a mechanism-based inactivator of MPO, it is of interest to evaluate the level of MPO activity in order to investigate the inhibition activity of PF-06282999.|Days 1, 3-5|Due to early termination of the study, there was not enough participants to perform meaningful analysis on this endpoint. As such, no analysis was done.|||||
654429|NCT01965600|Primary|Peak Myeloperoxidase (MPO) Activity Following Inflammatory Stimulus|MPO is a heme-containing peroxidase enzyme produced in the bone marrow and stored in the azurophilic granules of neutrophils, where it constitutes up to 5% of the cellular protein. Since PF-06282999 is a mechanism-based inactivator of MPO, it is of interest to evaluate the level of MPO activity in order to investigate the inhibition activity of PF-06282999.|Days 1, 3-5|Due to early termination of the study, there was not enough participants to perform meaningful analysis on this endpoint. As such, no analysis was done.|||||
654430|NCT01965561|Secondary|Pain During Tourniquet Application|Pain during tourniquet application as measured on a visual analog scale (VAS). The pain scale was a 100-mm-long line on a piece of paper. The subject made a cross mark on the line, which went from the left limit (0 mm) at no pain to the right limit (100 mm) at very severe pain.|1 minute|||mm on VAS||Standard Deviation|Mean
654431|NCT01965561|Primary|Effectiveness at Stopping Distal Pulse|Percentage of participants whose distal pulse ceased within 1 minute of junctional tourniquet application.|1 min|||percentage of participants|||Number
654432|NCT01965535|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure is defined as
On-treatment virologic failure:
Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)
Virologic relapse:
Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Baseline to Posttreatment Week 24|Full Analysis Set||percentage of participants|||Number
654433|NCT01965535|Secondary|Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12||Baseline; Weeks 1, 2, 4, 8, and 12|Participants in Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
654434|NCT01965535|Secondary|Percentage of Participants With HCV RNA < LLOQ (ie, < 25 IU/mL) at Weeks 1, 2, 4, 8, 12, and 24||Weeks 1, 2, 4, 8, 12, and 24|Full Analysis Set||percentage of participants|||Number
654435|NCT01965535|Secondary|Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set||percentage of participants|||Number
654436|NCT01965535|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|"SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, < 25 IU/mL) 12 weeks following the last dose of study drug.
1 participant who was randomized to the LDV/SOF + RBV group who received placebo discontinued prior to receiving LDV/SOF + RBV and is excluded from the Full Analysis Set.
1 participant who was randomized to the LDV/SOF + RBV group received LDV/SOF + placebo, and is counted in the LDV/SOF group for the safety analysis, and in the LDV/SOF+RBV group for the efficacy analysis (ie, in the Full Analysis Set)."|Posttreatment Week 12|Full Analysis Set: participant with genotype 1 HCV infection who were randomized and received at least 1 dose of active study drug.||percentage of participants|||Number
654437|NCT01965431|Secondary|Minimum Mean Placebo-corrected HR (Heart Rate) Change From Baseline Between 1 to 24 Hours on Day 1 for the Combination Therapy|Minimum mean placebo-corrected HR (heart rate) change from baseline between 1 to 24 hours on Day 1 for the combination therapy is estimated. HR was derived from the RR interval.|20min,15min and 10min prior to drug administration on day -2 (baseline) and 1h (hours), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h and 24h after drug adminstration on day 1|ECG analysis set (ECGS)||bpm||Standard Error|Mean
654438|NCT01965431|Secondary|Maximum Mean Placebo-corrected HR Change From Baseline Between 1 to 24 Hours on Day 1 for the Combination Therapy|Maximum mean placebo-corrected heart rate (HR) change from baseline between 1 to 24 hours on Day 1 for the combination therapy is estimated. HR was derived from the RR interval.|20min,15min and 10min prior to drug administration on day -2 (baseline) and 1h (hours), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h and 24h after drug adminstration on day 1|ECG analysis set (ECGS)||bpm||Standard Error|Mean
654439|NCT01965431|Secondary|Maximum Mean Placebo-corrected QTcN Change From Baseline Between 1 to 6 Hours on Day 1 for the Moxifloxacin Treatment|"Maximum mean placebo-corrected QTcN change from baseline between 1 to 6 hours on Day 1 for the Moxifloxacin treatment is estimated.
QTcN denotes the population heart rate corrected QT interval length, based on a parabolic model. ‘Baseline’ denotes the mean of the pre-dose ECG measurements prior to (first) dose at Visits 2, 3 or 4, determined separately for each treatment period. 'Global baseline' refers to the mean of all available period baseline values."|20min,15min and 10min prior to drug administration on day -2 (baseline) and 1h (hours), 2h, 3h, 4h, 5h and 6h after drug adminstration on day 1|ECG analysis set (ECGS)||ms||Standard Error|Mean
654440|NCT01965431|Primary|Maximum Mean Placebo-corrected QTcN Change From Baseline Between 1 to 24 Hours on Day 1 for the Combination Therapy|"Maximum mean placebo-corrected QT interval corrected for heart rate according to a parabolic population model (QTcN) change from baseline between 1 to 24 hours on Day 1 for the combination therapy is estimated.
QTcN denotes the population heart rate corrected QT interval length, based on a parabolic model. ‘Baseline’ denotes the mean of the pre-dose ECG measurements prior to (first) dose at Visits 2, 3 or 4, determined separately for each treatment period. 'Global baseline' refers to the mean of all available period baseline values."|20min,15min and 10min prior to drug administration on day -2 (baseline) and 1h (hours), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h and 24h after drug adminstration on day 1|Electrocardiogram (ECG) analysis set (ECGS): all subjects in the treated set who had at least 1 baseline and post-baseline assessment for at least 1 ECG endpoint.||ms||Standard Error|Mean
654457|NCT01965288|Primary|Overall Fit Acceptance|Assessment of Lens Fit Performance for overall lens fit acceptance. Collected at 2 weeks for each lens. Rated perfect or not perfect based on lens fit alone. (0-4; 0=should not be worn, 3=not perfect but OK to dispense, 4=perfect)|2 weeks|All 60 subjects randomized to both sets of lenses.||percentage of lenses|Participants||Number
654441|NCT01965327|Secondary|Change in Total Friedreich Ataxia Rating Scale (FARS) Score|The Friedreich Ataxia Rating Scale (FARS) is neurological rating scale specifically developed and validated for FRDA. The FARS includes assessments of stance, gait, upper and lower limb coordination, speech, proprioception and strength. In addition to the standard neurological examination, the FARS contains three quantitative performance measures and a component that assesses activities of daily living (ADL). Quantitative performance measures include the nine-hole peg test, and a timed 25-foot walk. FARS scores correlate significantly with functional disability, activities of daily living scores and disease duration. The scores from the three subscales are added to generate a total score ranging from 0 to 159, with a higher score indicating a greater level of disability.|FARS score was calculated at the beginning and conclusion of treatment (baseline and 12 weeks)|The analysis was based on an intent-to-treat approach and included all subjects with baseline FARS assessment.||units on a scale||Standard Deviation|Mean
654442|NCT01965327|Primary|Change in Whole Blood Frataxin Levels|Assessment of the change in whole blood frataxin levels as assessed by lateral flow assay using an immunoassay for frataxin. Frataxin levels in the blood were measured at each study visit. Change in frataxin level at the end of treatment (week 12) relative to frataxin level at baseline was analyzed.|Frataxin levels were measured at the beginning and conclusion of treatment (baseline and 12 weeks)|The primary analysis was based on an intent-to-treat approach including all subjects who had baseline frataxin blood levels collected.||percentage of baseline frataxin level||Standard Deviation|Mean
654443|NCT01965288|Secondary|Participant Preference for Either of the Study Lenses|"Percentage of participants that answer the question, Which type of study lens they prefer with regard to comfort, dryness, handling, vision, lens fit and overall performance? Collected at study end. (Forced choice; first study lenses, second study lenses, neither)"|8 weeks|All 60 subjects wore habitual lenses prior to randomization of study lenses.||percentage of participants|||Number
654444|NCT01965288|Secondary|Participant Preference for Their Habitual Lenses or Either of the Study Lenses|"Percentage of participants that answer the question, Which type of study lens they prefer with regard to comfort, dryness, handling, vision, lens fit and overall performance? Collected at study end. (Forced choice; habitual lenses, first study lenses, second study lenses)"|8 weeks|All 60 subjects wore habitual lenses prior to randomization of study lenses.||percentage of participants|||Number
654445|NCT01965288|Secondary|Participant Likelihood of Recommending a Study Lens to Friends, Family or Colleagues.|"Percentage of participants that answer the question, How likely are they to recommend either the first pair of study lenses or the second pair of study lenses to friends, family or colleagues? Collected at study end. (4 point Likert scale; very likely, likely, unlikely, very unlikely)"|8 weeks|All 60 subjects randomized to both sets of lenses.||percentage of participants|||Number
654446|NCT01965288|Secondary|Participant Recommendation of a Study Lens to Friends, Family or Colleagues|"Percentage of participants that answer the question, What study lens they will most likely recommend to friends, family or colleagues? Collected at end of study. (Forced choice; First Study Lenses, Second Study Lenses)"|8 weeks|All 60 subjects randomized to both sets of lenses.||percentage of participants|||Number
654447|NCT01965288|Secondary|Participants Likelihood of Continuing to Wear the Study Lenses.|"Participants likelihood of continuing to wear either of the pairs of study lenses when asked; How likely are they to continue to wearing either the first study lenses or the second study lenses? Collected at 4 weeks fore each study pair. (4 point Likert scale; very likely, likely, unlikely, very unlikely)"|4 weeks|All 60 subjects randomized to both sets of lenses.||percentage of participants|||Number
654448|NCT01965288|Secondary|Participants Likelihood of Switching From Habitual Lenses to the Study Lenses|"Participants likelihood of switching from habitual lenses to either pair of the study lenses when asked; How likely are they to switch from their habitual lenses to either the first study lenses or the second study lenses? Collected at 4 weeks for each study pair. (4 point Likert scale; very likely, likely, unlikely, very unlikely)"|4 weeks|All 60 subjects randomized to both sets of lenses.||percentage of particpants|||Number
654449|NCT01965288|Secondary|Participant Preference for Their Habitual Lenses or the First Study Lenses (Comfilcon A)|Participant preference for their habitual lenses or the first study lenses during the last four weeks with regard to comfort, dryness, handling, vision, lens fit and overall. (Forced choice; habitual, study lenses)|4 weeks|All 60 subjects were habitual lense wearers and randomized to both sets of study lenses.||percentage of participants|||Number
654450|NCT01965288|Secondary|Participant Preference for Their Habitual Lenses or the First Study Lenses (Lotrafilcon B)|Participant preference for their habitual lenses or the first study lenses during the last four weeks with regard to comfort, dryness, handling, vision, lens fit and overall. (Forced choice; habitual, study lenses)|4 weeks|All 60 subjects were habitual lense wearers and randomized to both sets of study lenses.||percentage of participants|||Number
654451|NCT01965288|Secondary|Participant Preference for Their Habitual Lenses or the First Study Lenses (Comfilcon A)|Participant preference for their habitual lenses or the first study lenses during the last two weeks with regard to comfort, dryness, handling, vision, lens fit and overall. (Forced choice; habitual, study lenses)|2 weeks|All 60 subjects were habitual lense wearers and randomized to both sets of study lenses.||percentage of patients|||Number
654452|NCT01965288|Secondary|Participant Preference for Their Habitual Lenses or the First Study Lenses (Lotrafilcon B)|Participant preference for their habitual lenses or the first study lenses during the last two weeks with regard to comfort, dryness, handling, vision, lens fit and overall. (Forced choice; habitual, study lenses)|2 weeks|All 60 subjects were habitual lense wearers and randomized to both sets of study lenses.||percentage of patients|||Number
654453|NCT01965288|Secondary|Corneal Infiltrates|Assessment of ocular health. Collected at 4 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|4 weeks|All 60 subjects randomized to both sets of lenses.||percentage of eyes|Participants||Number
654454|NCT01965288|Secondary|Corneal Infiltrates|Assessment of ocular health. Collected at 2 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|2 weeks|All 60 subjects randomized to both sets of lenses.||percentage of eyes|Participants||Number
654455|NCT01965288|Secondary|Corneal Infiltrates|Assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|Baseline|All 60 subjects randomized to both sets of lenses.||percentage of eyes|Participants||Number
654460|NCT01965288|Secondary|Corneal Neovascularization|Assessment of ocular health. Collected at 4 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|4 weeks|All 60 subjects randomized to both sets of lenses.||percentage of eyes|Participants||Number
654461|NCT01965288|Secondary|Corneal Neovascularization|Assessment of ocular health. Collected at 2 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|2 weeks|All 60 subjects randomized to both sets of lenses.||percentage of eyes|Participants||Number
654462|NCT01965288|Secondary|Corneal Neovascularization|Investigators' objective assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|Baseline|All 60 subjects randomized to both sets of lenses.||percentage of eyes|Participants||Number
654463|NCT01965288|Secondary|Corneal Stromal Haze|Assessment of ocular health. Collected at 4 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|4 weeks|All 60 subjects randomized to both sets of lenses.||percentage of eyes|Participants||Number
654464|NCT01965288|Secondary|Corneal Stromal Haze|Assessment of ocular health. Collected at 2 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|2 weeks|All 60 subjects randomized to both sets of lenses.||percentage of eyes|Participants||Number
654465|NCT01965288|Secondary|Corneal Stromal Haze|Assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|Baseline|All 60 subjects randomized to both sets of lenses.||percentage of eyes|Participants||Number
654466|NCT01965288|Secondary|Lower Palpebral Hyperaemia|Assessment of ocular health. Collected at 4 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|4 weeks|All 60 subjects randomized to both sets of lenses.||percentage of eyes|Participants||Number
654467|NCT01965288|Secondary|Lower Palpebral Hyperaemia|Assessment of ocular health. Collected at 2 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|2 weeks|All 60 subjects randomized to both sets of lenses.||percentage of eyes|Participants||Number
654468|NCT01965288|Secondary|Lower Palpebral Hyperaemia|Assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|Baseline|All 60 subjects randomized to both sets of lenses.||percentage of eyes|Participants||Number
654469|NCT01965288|Secondary|Bulbar Hyperaemia|Assessment of ocular health. Collected at 4 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|4 weeks|All 60 subjects randomized to both sets of lenses.||percentage of eyes|Participants||Number
654470|NCT01965288|Secondary|Bulbar Hyperaemia|Assessment of ocular health. Collected at 2 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|2 weeks|All 60 subjects randomized to both sets of lenses.||percentage of eyes|Participants||Number
654471|NCT01965288|Secondary|Bulbar Hyperaemia|Assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|Baseline|All 60 subjects randomized to both sets of lenses.||percentage of eyes|Participants||Number
654472|NCT01965288|Secondary|Limbal Hyperaemia|Assessment of ocular health. Collected at 4 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|4 weeks|All 60 subjects randomized to both sets of lenses.||percentage of eyes|Participants||Number
654473|NCT01965288|Secondary|Limbal Hyperaemia|Assessment of ocular health. Collected at 2 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|2 weeks|All 60 subjects randomized to both sets of lenses.||percentage of eyes|Participants||Number
654474|NCT01965288|Primary|Lens Stability 5-10 Min|Assessment of Lens Fit Performance for lens to stabilize in 5-10 min. Collected at 4 weeks for each lens. Varied less than 5 degrees from lens marking location between 5-10 min.|4 weeks|All 60 subjects randomized to both sets of lenses.||percentage of lenses|Participants||Number
654475|NCT01965288|Primary|Lens Stability 5-10 Min|Assessment of Lens Fit Performance for lens to stabilize in 5-10 min. Collected at 2 weeks for each lens. Varied less than 5 degrees from lens marking location between 5-10 min.|2 weeks|All 60 subjects randomized to both sets of lenses.||percentage of lenses|Participants||Number
654476|NCT01965288|Primary|Lens Stability on Blink|Assessment of Lens Fit Performance for lens rotational stability on blink. Collected at 4 weeks for each lens. (No rotation and 5-10 degrees rotation from axis location mark)|4 weeks|All 60 subjects randomized to both sets of lenses.||percentage of lenses|Participants||Number
654477|NCT01965288|Primary|Lens Stability on Blink|Assessment of Lens Fit Performance for lens rotational stability on blink. Collected at 2 weeks for each lens. (No rotation and 5-10 degrees rotation from axis location mark)|2 weeks|All 60 subjects randomized to both sets of lenses.||percentage of lenses|Participants||Number
654478|NCT01965288|Primary|Lens Marking Visibility|Assessment of Lens Fit Performance for lens marking visibility. Collected at 4 weeks for each lens. (1-3, 1=excellent, 2=average, 3=poor)|4 weeks|All 60 subjects randomized to both sets of lenses.||percentage of lenses|Participants||Number
654479|NCT01965288|Primary|Lens Marking Visibility|Assessment of Lens Fit Performance for lens marking visibility. Collected at 2 weeks for each lens. (1-3, 1=excellent, 2=average, 3=poor)|2 weeks|All 60 subjects randomized to both sets of lenses.||percentage of lenses|Participants||Number
654480|NCT01965288|Primary|Post Blink Movement|Assessment of Lens Fit Performance for post blink movement. Collected at 4 weeks for each lens. (0-4, 0.5 increments; 0=Insufficient, unacceptable movement, 4= Excessive, unacceptable movement)|4 weeks|All 60 subjects randomized to both sets of lenses.||units on a scale|Participants|Standard Deviation|Mean
674021|NCT01656252|Secondary|Phase II- Bleeding Event Occurrence|To determine the impact of eltrombopag on occurrence of bleeding events.|62 months||||||
654481|NCT01965288|Primary|Post Blink Movement|Assessment of Lens Fit Performance for post blink movement. Collected at 2 weeks for each lens. (0-4, 0.5 increments; 0=Insufficient, unacceptable movement, 4= Excessive, unacceptable movement)|2 weeks|All 60 subjects randomized to both sets of lenses.||units on a scale|Participants|Standard Deviation|Mean
654482|NCT01965288|Primary|Corneal Coverage|Assessment of Lens Fit Performance for corneal coverage. Collected at 4 weeks for each lens. Corneal coverage assessed in primary gaze: (yes=full corneal coverage at all times, no=incomplete corneal coverage)|4 weeks|All 60 subjects randomized to both sets of lenses.||percentage of lenses|Participants||Number
654483|NCT01965288|Primary|Corneal Coverage|Assessment of Lens Fit Performance for corneal coverage. Collected at 2 weks for each lens. Corneal coverage assessed in primary gaze: (yes=full corneal coverage at all times, no=incomplete corneal coverage)|2 weeks|All 60 subjects randomized to both sets of lenses.||percentage of lenses|Participants||Number
654484|NCT01965288|Primary|Centration|Assessment of Lens Fit Performance for centration. Collected at 4 weeks for each lens. Proportion of contact lenses fitted where centration was centered or slightly decentered. (Biomicroscopy)|4 weeks|All 60 subjects randomized to both sets of lenses.||percentage of lenses|Participants||Number
654485|NCT01965288|Primary|Centration|Assessment of Lens Fit Performance for centration. Collected at 2 weeks for each lens. Proportion of contact lenses fitted where centration was centered or slightly decentered. (Biomicroscopy)|2 weeks|All 60 subjects randomized to both sets of lenses.||percentage of lenses|Participants||Number
654486|NCT01965288|Primary|Lens Surface Deposits|Assessment of lens front surface deposits. Collected at 4 weeks wear for each lens. (Front surface deposits observed, 0-4, 0=clean, 4=deposits ≥0.5)|4 weeks|All 60 subjects randomized to both sets of lenses.||units on a scale|Participants|Standard Deviation|Mean
654487|NCT01965288|Primary|Lens Surface Deposits|Assessment of lens front surface deposits. Collected at 2 weeks wear for each lens. (Front surface deposits observed, 0-4, 0=clean, 4=deposits ≥0.5)|2 weeks|All 60 subjects randomized to both sets of lenses.||units on a scale|Participants|Standard Deviation|Mean
654488|NCT01965288|Primary|Rotational Recovery 30/45 Deg|Assessment of Lens Fit Performance for lens rotational recovery to original position. Collected at 2 weeks wear for each lens. Assessed in degree of mislocation relative to original position after manual temporal rotation. (30 deg/10 blinks, 45 deg/60 sec)|4 weeks|All 60 subjects randomized to both sets of lenses.||degrees|Participants|Standard Deviation|Mean
654489|NCT01965288|Primary|Rotational Recovery 30/45 Deg|Assessment of Lens Fit Performance for lens rotational recovery to original position. Collected at 2 weeks wear for each lens. Assessed in degree of mislocation relative to original position after manual temporal rotation. (30 deg/10 blinks, 45 deg/60 sec)|2 weeks|All 60 subjects randomized to both sets of lenses.||degrees|Participants|Standard Deviation|Mean
654490|NCT01965288|Primary|Lens Orientation Primary Gaze|Assessment of Lens Fit Performance for lens orientation in primary position of gaze. Assessed at 4 weeks wear for each lens. (Degree of mislocation relative to lens axis mark.)|4 weeks|All 60 subjects randomized to both sets of lenses.||degrees|Participants|Standard Deviation|Mean
654491|NCT01965288|Primary|Lens Orientation Primary Gaze|Assessment of Lens Fit Performance for lens orientation in primary position of gaze. Assessed at 2 weeks wear for each lens. (Degree of mislocation relative to lens axis mark.)|2 weeks|All 60 subjects randomized to both sets of lenses.||degrees|Participants|Standard Deviation|Mean
654492|NCT01965288|Primary|Visual Acuity logMAR|"Assessment of monocular and binocular high and low contrast visual acuity (VA). Collected at 4 weeks for each lens. logMAR (VA).
Monocular High Contrast Visual Acuity (MHCVA), Monocular Low Contrast Visual Acuity (MLCVA), Binocular High Contrast Visual Acuity (BHCVA), Binocular Low Contrast Visual Acuity (BLCVA)"|4 Weeks|All 60 subjects randomized to both sets of lenses.||logMAR||Standard Deviation|Log Mean
654493|NCT01965288|Primary|Visual Acuity logMAR|"Assessment of monocular and binocular high and low contrast visual acuity (VA). Collected at 2 weeks for each lens. logMAR (VA).
Monocular High Contrast Visual Acuity (MHCVA), Monocular Low Contrast Visual Acuity (MLCVA), Binocular High Contrast Visual Acuity (BHCVA), Binocular Low Contrast Visual Acuity (BLCVA)"|2 Weeks|All 60 subjects randomized to both sets of lenses.||logMAR||Standard Deviation|Log Mean
654494|NCT01965288|Primary|Wavefront Aberrations RMS (5mm)|Assessment of wavefront aberrations. Collected at 4 weeks for each lens. Wavefront measurement (5 mm), Scale in microns (µm).|4 Weeks|All 60 subjects randomized to both sets of lenses.||microns|Participants|Standard Deviation|Mean
654495|NCT01965288|Primary|Wavefront Aberrations RMS (5mm)|Assessment of wavefront aberrations. Collected at 2 weeks for each lens. Wavefront measurement (5 mm), Scale in microns (µm).|2 Weeks|All 60 subjects randomized to both sets of lenses.||microns|Participants|Standard Deviation|Mean
654496|NCT01965288|Primary|Wavefront Aberrations RMS (3mm)|Assessment of wavefront aberrations. Collected at 4 weeks for each lens. Wavefront measurement (3mm), Scale in microns (µm).|4 Weeks|All 60 subjects randomized to both sets of lenses.||microns|Participants|Standard Deviation|Mean
654497|NCT01965288|Primary|Wavefront Aberrations Root Mean Square (RMS) (3mm)|Assessment of wavefront aberrations. Collected at 2 weeks for each lens. Wavefront measurement (3mm), Scale in microns (µm).|2 Weeks|All 60 subjects randomized to both sets of lenses.||microns|Participants|Standard Deviation|Mean
654498|NCT01965288|Primary|Overall Satisfaction|Participant rating for overall satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|4 weeks|All 60 subjects randomized to both sets of lenses.||percentage of participants|||Number
654499|NCT01965288|Primary|Overall Satisfaction|Participant rating for overall satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|2 weeks|All 60 subjects randomized to both sets of lenses.||percentage of participants|||Number
654500|NCT01965288|Primary|Lens Fit Satisfaction|Participant rating for lens fit satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|4 weeks|All 60 subjects randomized to both sets of lenses.||percentage of participants|||Number
654501|NCT01965288|Primary|Lens Fit Satisfaction|Participant rating for lens fit satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|2 weeks|All 60 subjects randomized to both sets of lenses.||percentage of participants|||Number
654502|NCT01965288|Primary|Vision Satisfaction|Participant rating for vision satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|4 weeks|All 60 subjects randomized to both sets of lenses.||percentage of participants|||Number
654503|NCT01965288|Primary|Vision Satisfaction|Participant rating for vision satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|2 weeks|All 60 subjects randomized to both sets of lenses.||percentage of participants|||Number
654504|NCT01965288|Primary|Handling Satisfaction|Participant rating for handling satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|4 weeks|All 60 subjects randomized to both sets of lenses.||percentage of participants|||Number
654505|NCT01965288|Primary|Handling Satisfaction|Participant rating for handling satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|2 weeks|All 60 subjects randomized to both sets of lenses.||percentage of participants|||Number
654506|NCT01965288|Primary|Dryness Satisfaction|Participant rating for dryness satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|4 weeks|All 60 subjects randomized to both sets of lenses.||percentage of participants|||Number
654507|NCT01965288|Primary|Dryness Satisfaction|Participant rating for dryness satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|2 weeks|All 60 subjects randomized to both sets of lenses.||percentage of participants|||Number
654508|NCT01965288|Primary|Comfort Satisfaction|Participant rating for comfort satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|4 weeks|All 60 subjects randomized to both sets of lenses.||percentage of participants|||Number
654509|NCT01965288|Primary|Comfort Satisfaction|Participant rating for comfort satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|2 weeks|All 60 subjects randomized to both sets of lenses.||percentage of participants|||Number
654510|NCT01965288|Primary|Overall Sensation of Smoothness|Participant rating for overall sensation of smoothness. Collected at 4 weeks wear for each lens. (5-point Likert Scale; Excellent, Good, Average, Below Average, Poor)|4 weeks|All 60 subjects randomized to both sets of lenses.||percentage of participants|||Number
654511|NCT01965288|Primary|Overall Sensation of Smoothness|Participant rating for overall sensation of smoothness. Collected at 2 weeks wear for each lens. (5-point Likert Scale; Excellent, Good, Average, Below Average, Poor)|2 weeks|All 60 subjects randomized to both sets of lenses.||percentage of participants|||Number
654512|NCT01965288|Primary|Overall Sensation of Moistness|Participant rating for overall sensation of moistness. Collected at 4 weeks wear for each lens. (5-point Likert Scale; Excellent, Good, Average, Below Average, Poor)|4 weeks|All 60 subjects randomized to both sets of lenses.||percentage of participants|||Number
654513|NCT01965288|Primary|Overall Sensation of Moistness|Participant rating for overall sensation of moistness. Collected at 2 weeks wear for each lens. (5-point Likert Scale; Excellent, Good, Average, Below Average, Poor)|2 weeks|All 60 subjects randomized to both sets of lenses.||percentage of participants|||Number
654514|NCT01965288|Primary|Vision Stability on Insertion, During Day, End Day|Participant rating of vision stability on insertion, during the day, end of day. Collected at 4 weeks wear for each lens. (0-100; 0=totally unstable fluctuating/changing, 100=perfectly stable not fluctuating/changing)|4 weeks|All 60 subjects randomized to both sets of lenses.||units on a scale||Standard Deviation|Mean
654515|NCT01965288|Primary|Vision Stability on Insertion, During Day, End Day|Participant rating of vision stability on insertion, during the day, end of day. Collected at 2 weeks wear for each lens. (0-100; 0=totally unstable fluctuating/changing, 100=perfectly stable not fluctuating/changing)|2 weeks|All 60 subjects randomized to both sets of lenses.||units on a scale||Standard Deviation|Mean
654516|NCT01965288|Primary|Vision Quality Insertion, During Day, End Day, Night|Participant rating of vision quality on insertion, during the day, end of day and night. Collected at 4 weeks wear for each lens. (0-100; 0=extremely poor vision totally blurred, 100=excellent vision totally sharp)|4 weeks|All 60 subjects randomized to both sets of lenses.||units on a scale||Standard Deviation|Mean
654517|NCT01965288|Primary|Vision Quality Insertion, During Day, End Day, Night|Participant rating of vision quality on insertion, during the day, end of day and night. Collected at 2 weeks wear for each lens. (0-100; 0=extremely poor vision totally blurred, 100=excellent vision totally sharp)|2 weeks|All 60 subjects randomized to both sets of lenses.||units on a scale||Standard Deviation|Mean
654518|NCT01965288|Primary|Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction|Participant rating of lens Comfort, Dryness, Handling, Lens Fit Stability and Vision Satisfaction. Collected at 4 weeks wear for each lens. (0-10; Comfort, Lens Fit and Satisfaction / 0=very poor,10=excellent; Dryness / 0=very dry, 10=no dryness; Handling / 0=very difficult, 10=very easy for handling)|4 weeks|All 60 subjects randomized to both sets of lenses.||units on a scale||Standard Deviation|Mean
654519|NCT01965288|Primary|Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction|Participant rating of lens Comfort, Dryness, Handling, Lens Fit Stability and Vision Satisfaction. Collected at 2 weeks wear for each lens. (0-10; Comfort, Lens Fit and Satisfaction / 0=very poor,10=excellent; Dryness / 0=very dry, 10=no dryness; Handling / 0=very difficult, 10=very easy for handling)|2 weeks|All 60 subjects randomized to both sets of lenses.||units on a scale||Standard Deviation|Mean
654520|NCT01965288|Primary|Participants Use of Rewetting Drops|Proportion of subjects using rewetting drops. Collected at 4 weeks for each lens. (Yes, No)|4 Weeks|All 60 subjects randomized to both sets of lenses.||percentage of participants|||Number
654521|NCT01965288|Primary|Participants Use of Rewetting Drops|Proportion of subjects using rewetting drops. Collected at 2 weeks for each lens. (Yes, No)|2 Weeks|All 60 subjects randomized to both sets of lenses.||percentage of participants|||Number
654522|NCT01965288|Primary|Daily and Comfortable Wearing Time|Participant rating of lens Daily and Comfortable Wearing Time. Collected at 4 weeks wear for each lens. (The hours of average comfortable wearing time and average daily wearing time.)|4 weeks|All 60 subjects randomized to both sets of lenses.||hours||Standard Deviation|Mean
654523|NCT01965288|Primary|Daily and Comfortable Wearing Time|Participant rating of lens Daily and Comfortable Wearing Time. Collected at 2 weeks wear for each lens. (The hours of average comfortable wearing time and average daily wearing time.)|2 weeks|All 60 subjects randomized to both sets of lenses.||hours||Standard Deviation|Mean
654524|NCT01965288|Primary|Overall Fit Acceptance|Assessment of Lens Fit Performance for overall lens fit acceptance. Collected at dispense for each lens. Rated perfect or not perfect based on lens fit alone. (0-4; 0=should not be worn, 3=not perfect but OK to dispense, 4=perfect)|Dispense|All 60 subjects randomized to both sets of lenses.||percentage of lenses fitted|Participants||Number
654525|NCT01965288|Primary|Rotational Recovery 30/45 Deg|Assessment of Lens Fit Performance for lens rotational recovery to original position. Collected at dispense for each lens. Assessed in degree of mislocation relative to original position after manual temporal rotation. (30 deg/10 blinks, 45 deg/60 sec)|Dispense|All 60 subjects randomized to both sets of lenses.||degrees|Participants|Standard Deviation|Mean
654526|NCT01965288|Primary|Lens Overall Stability|Assessment of Lens Fit Performance for overall lens stability. Collected at dispense for each lens. (Excellent or Good)|Dispense|All 60 subjects randomized to both sets of lenses.||percentage of lenses|Participants||Number
654527|NCT01965288|Primary|Lens Stability 5-10 Min|Assessment of Lens Fit Performance for lens to stabilize in 5-10 min. Collected at dispense for each lens. (Varied less than 5 degrees from lens marking location between 5-10 min)|Dispense|All 60 subjects randomized to both sets of lenses.||percentage of lenses|Participants||Number
654528|NCT01965288|Primary|Lens Stability on Blink|Assessment of Lens Fit Performance for lens rotational stability on blink. Collected at dispense for each lens. (No rotation and 5-10 degrees rotation from axis location mark)|Dispense|All 60 subjects randomized to both sets of lenses.||percentage of lenses|Participants||Number
654529|NCT01965288|Primary|Lens Marking Visibility|Assessment of Lens Fit Performance for lens marking visibility. Collected at dispense for each lens. (1-3, 1=excellent, 2=average, 3=poor)|Dispense|All 60 subjects randomized to both sets of lenses.||percentage of lenses|Participants||Number
654530|NCT01965288|Primary|Lens Orientation Primary Gaze|Assessment of Lens Fit Performance for lens orientation in primary position of gaze. Collected at dispense for each lens. (Degree of mislocation relative to lens axis mark.)|Dispense|All 60 subjects randomized to both sets of lenses.||degrees|Participants|Standard Deviation|Mean
654531|NCT01965288|Primary|Post Blink Movement|Assessment of Lens Fit Performance for post blink movement. Collected at dispense for each lens. (0-4, 0.5 increments; 0=Insufficient, unacceptable movement, 4= Excessive, unacceptable movement)|Dispense|All 60 subjects randomized to both sets of lenses.||units on a scale|Participants|Standard Deviation|Mean
654532|NCT01965288|Primary|Corneal Coverage|Assessment of Lens Fit Performance for corneal coverage. Collected at dispense for each lens. Corneal coverage assessed in primary gaze: (yes=full corneal coverage at all times, no=incomplete corneal coverage)|Dispense|All 60 subjects randomized to both sets of lenses.||percentage of lenses|Participants||Number
654533|NCT01965288|Primary|Centration|Assessment of Lens Fit Performance for centration. Collected at dispense for each lens. (Biomicroscopy; centered or slightly decentered)|Dispense|All 60 subjects randomized to both sets of lenses.||percentage of lenses|Participants||Number
654534|NCT01965288|Primary|Visual Acuity logMAR|Assessment of monocular and binocular high and low contrast visual acuity (VA). Collected at dispense for each lens. logMAR (VA).|Dispense|All 60 subjects randomized to both sets of lenses.||logMAR|Participants|Standard Deviation|Log Mean
654535|NCT01965288|Primary|Vision Stability Upon Contact Lens Insertion|Participant rating of vision stability on insertion. Collected at dispense for each lens. (0-100; 0=extremely poor vision totally blurred, 100=excellent vision totally sharp)|Dispense|All 60 subjects randomized to both sets of lenses.||units on a scale||Standard Deviation|Mean
654536|NCT01965288|Primary|Vision Quality With Contact Lens Prescription|Participant rating of Vision Quality with contact lens prescription. Collected at dispense for each lens. (0-100; 0=extremely poor vision totally blurred, 100=excellent vision totally sharp)|Dispense|All 60 subjects randomized to both sets of lenses.||units on a scale||Standard Deviation|Mean
654537|NCT01965288|Primary|Vision Satisfaction Upon Contact Lens Insertion|Participant rating of vision satisfaction upon insertion. Collected at dispense for each lens. (0-10; 10= Very Satisfied)|Dispense|All 60 subjects randomized to both sets of lenses.||units on a scale||Standard Deviation|Mean
654538|NCT01965288|Primary|Comfort Upon Contact Lens Insertion|Participant rating of comfort upon insertion. Collected at dispense for each lens. (0-10; 10=Can't Feel)|Dispense|All 60 subjects randomized to both sets of lenses.||units on a scale||Standard Deviation|Mean
654539|NCT01965288|Primary|Overall Satisfaction|Participant rating for overall satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|Baseline|||percentage of participants|||Number
654540|NCT01965288|Primary|Vision Satisfaction|Participant rating for vision satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|Baseline|||percentage of participants|||Number
654541|NCT01965288|Primary|Lens Fit Satisfaction|Participant rating for lens fit satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|Baseline|||percentage of participants|||Number
654542|NCT01965288|Primary|Handling Satisfaction|Participant rating for handling satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|Baseline|||percentage of participants|||Number
654543|NCT01965288|Primary|Dryness Satisfaction|Participant rating for dryness satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|Baseline|||percentage of participants|||Number
654544|NCT01965288|Primary|Comfort Satisfaction|Participant rating for comfort satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|Baseline|||percentage of participants|||Number
654545|NCT01965288|Primary|Overall Sensation of Smoothness|Participant rating for overall sensation of smoothness. Collected at baseline for all habitual lenses. (5-point Likert Scale; Excellent, Good, Average, Below Average)|Baseline|||percentage of participants|||Number
654547|NCT01965288|Primary|Vision Stability Insertion, During Day, End Day|Participant rating of vision stability on insertion, during the day, end of day. Collected at baseline for all habitual lenses. (0-100; 0=totally unstable fluctuating/changing, 100=perfectly stable not fluctuating/changing)|Baseline|||units on a scale||Standard Deviation|Mean
654548|NCT01965288|Primary|Vision Quality Insertion, During Day, End Day|Participant rating of vision quality on insertion, during the day, end of day. Collected at baseline for all habitual lenses. (0-100; 0=extremely poor vision totally blurred, 100=excellent vision totally sharp)|Baseline|||units on a scale||Standard Deviation|Mean
654549|NCT01965288|Primary|Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction|Participant rating of lens Comfort, Dryness, Handling, Lens Fit Stability and Vision Satisfaction. Collected at baseline for all habitual lenses. (0-10; Comfort, Lens Fit and Satisfaction / 0=very poor,10=excellent; Dryness / 0=very dry, 10=no dryness; Handling / 0=very difficult, 10=very easy for handling)|Baseline|||units on a scale||Standard Deviation|Mean
654550|NCT01965288|Secondary|Limbal Hyperaemia|Assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|Baseline|||percentage of eyes|Participants||Number
654551|NCT01965288|Primary|Daily and Comfortable Wearing Time|Participant rating of lens Daily and Comfortable Wearing Time. Collected at baseline for all habitual lenses. (The hours of average comfortable wearing time and average daily wearing time.)|Baseline|||hours||Standard Deviation|Mean
654552|NCT01965262|Primary|Overall Impression (Subjective Assessment) - Hema-copolymer and Etafilcon A|Subjective assessment of the overall impression for hema-copolymer and etafilcon A lenses assessed at 1 week. Scale 0-100, 0=extremely poor, 100= excellent.|1 week|11 subjects discontinued the study. Missing data of 1 subject for hema-copolymer group.||units on a scale||Standard Deviation|Mean
654553|NCT01965262|Primary|Overall Impression (Subjective Assessment) - Hema-copolymer and Etafilcon A|Subjective assessment of the overall impression for hema-copolymer and etafilcon A lenses assessed at baseline. Scale 0-100, 0=extremely poor, 100= excellent.|Baseline|8 subjects discontinued the study.||units on a scale||Standard Deviation|Mean
654554|NCT01965262|Primary|Attractiveness (Subjective Assessment) - Hema-copolymer and Etafilcon A|Subjective Assessment of attractiveness for hema-copolymer and etafilcon A lenses assessed at 1 week. Scale 0-100, 0=extremely poor, 100= excellent.|1 week|11 subjects discontinued the study.||units on a scale||Standard Deviation|Mean
654555|NCT01965262|Primary|Attractiveness (Subjective Assessment) - Hema-copolymer and Etafilcon A|Subjective Assessment of attractiveness for hema-copolymer and etafilcon A lenses assessed at baseline. Scale 0-100, 0=extremely poor, 100= excellent.|Baseline|8 subjects discontinued the study.||units on a scale||Standard Deviation|Mean
654556|NCT01965262|Primary|Handling (Subjective Assessment) - Hema-copolymer and Etafilcon A|Subjective Assessment of handling (ease of insertion and ease of removal) for hema-copolymer and etafilcon A lenses assessed at 1 week. Scale 0-100, 0=unmanageable, 100= excellent.|1 week|11 subjects discontinued the study.||units on a scale||Standard Deviation|Mean
654557|NCT01965262|Primary|Ocular Redness (Subjective Assessment) - Hema-copolymer and Etafilcon A|Subjective Assessment of ocular redness for hema-copolymer and etafilcon A lenses lenses assessed at 1 week. Scale 0-100, 0=extremely poor, 100= excellent.|1 week|11 subjects discontinued the study.||units on a scale||Standard Deviation|Mean
654558|NCT01965262|Primary|Peripheral Blur (Subjective Assessment) - Hema-copolymer and Etafilcon A|Subjective Assessment of peripheral blur assessed at 1 week. Scale 0-100, 0=unacceptable, 100= excellent.|1 week|11 subjects discontinued the study.||units on a scale||Standard Deviation|Mean
654559|NCT01965262|Primary|Peripheral Blur (Subjective Assessment) - Hema-copolymer and Etafilcon A|Subjective Assessment of peripheral blur is assessed at baseline. Scale 0-100, 0=unacceptable, 100= excellent.|Baseline|8 subjects discontinued the study.||units on a scale||Standard Deviation|Mean
654560|NCT01965262|Primary|Vision Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A|Subjective Assessment of vision preference for hema-copolymer and etafilcon A lenses assessed at 1 week. Scale 0-100, 0=unacceptable, 100= excellent.|1 week|11 subjects discontinued the study.||units on a scale||Standard Deviation|Mean
654561|NCT01965262|Primary|Vision Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A|Subjective Assessment of vision preference for hema-copolymer and etafilcon A lenses assessed at baseline. Scale 0-100, 0=unacceptable, 100= excellent.|Baseline|8 subjects discontinued the study.||units on a scale||Standard Deviation|Mean
654562|NCT01965262|Primary|Comfort Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A|Subjective Assessment of comfort preference after insertion and before removal for hema-copolymer and etafilcon A lenses is assessed at 1 week. Scale 0-100, 0=causes pain, 100= excellent.|1 week|11 subjects discontinued the study.||units on a scale||Standard Deviation|Mean
654563|NCT01965262|Primary|Comfort Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A|Subjective Assessment of comfort preference for hema-copolymer and etafilcon A assessed at baseline. Scale 0-100, 0=causes pain, 100= excellent.|Baseline|7 subjects discontinued the study.||units on a scale||Standard Deviation|Mean
654564|NCT01965262|Primary|Lens Fit - Lens Movement - Hema-copolymer and Etafilcon A|Lens fit of lens movement for hema-copolymer and etafilcon A lenses assessed at 1 week. Overall score measured by extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive|1 week|11 subjects discontinued the study.||Eyes|Eyes||Number
654565|NCT01965262|Primary|Lens Fit - Lens Movement - Hema-copolymer and Etafilcon A|Lens fit of lens movement for hema-copolymer and etafilcon A lenses assessed at baseline. Overall score measured by extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive|Baseline|All 30 subjects were dispensed lenses, and lens movement measurements were obtained at baseline.||Eyes|Eyes||Number
654566|NCT01965262|Primary|Lens Fit - Corneal Centration - Hema-copolymer and Etafilcon A|Lens fit of corneal centration for hema-copolymer and etafilcon A lenses assessed at 1 week. Overall score measured by extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive|1 week|11 subjects discontinued the study.||Eyes|Eyes||Number
654567|NCT01965262|Primary|Lens Fit - Corneal Centration - Hema-copolymer and Etafilcon A|Lens fit of corneal centration for hema-copolymer and etafilcon A lenses assessed at baseline. Overall score measured by extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive|Baseline|All 30 subjects were dispensed lenses, and lens fit of corneal centration measurements were obtained at baseline.||Eyes|Eyes||Number
654568|NCT01965262|Primary|Lens Fit - Vertical Centration - Hema-copolymer and Etafilcon A|Lens fit of vertical centration for hema-copolymer and etafilcon A lenses assessed at 1 week. Overall score measured by extremely inferior, slightly inferior, optimum, slightly superior, extremely superior|1 week|11 subjects discontinued the study.||Eyes|Eyes||Number
654569|NCT01965262|Primary|Lens Fit - Vertical Centration - Hema-copolymer and Etafilcon A|Lens fit of vertical centration for hema-copolymer and etafilcon A lenses assessed at baseline. Overall score measured by extremely inferior, slightly inferior, optimum, slightly superior, extremely superior|Baseline|All 30 subjects were dispensed lenses, and lens fit of vertical centration measurements were obtained at baseline.||Eyes|Eyes||Number
654570|NCT01965262|Primary|Lens Fit - Horizontal Centration - Hema-copolymer and Etafilcon A|Lens fit of horizontal centration for hema-copolymer and etafilcon A lenses assessed at 1 week. Overall score measured by extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal|1 week|11 subjects discontinued the study.||Eyes|Eyes||Number
654571|NCT01965262|Primary|Lens Fit - Horizontal Centration - Hema-copolymer and Etafilcon A|Lens fit of horizontal centration for hema-copolymer and etafilcon A lenses assessed at baseline. Overall score measured by extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal|Baseline|All 30 subjects were dispensed lenses, and lens fit of horizontal centration measurements were obtained at baseline.||Eyes|Eyes||Number
654572|NCT01965262|Primary|Lens Surface - Wettability - Hema-copolymer and Etafilcon A|Lens surface of wettability for hema-copolymer and etafilcon A pair lenses assessed at 1 week. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=fully wetting lens surface, 4=presence of one or more non-wetting areas.|1 week|11 subjects discontinued the study.||participants|||Number
654573|NCT01965262|Primary|Lens Surface - Wettability - Hema-copolymer and Etafilcon A|Lens surface of wettability for hema-copolymer and etafilcon A pair of lenses assessed at baseline. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=fully wetting lens surface, 4=presence of one or more non-wetting areas.|Baseline|All 30 subjects were dispensed lenses, and lens surface of wettability measurements were obtained at baseline.||participants|||Number
654574|NCT01965262|Primary|Lens Surface - Debris - Hema-copolymer and Etafilcon A|Lens surface of debris for hema-copolymer and etafilcon A pair of lenses assessed at 1 week. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=no debris present, 4=debris present more than two thirds of area beneath lens.|1 week|11 subjects discontinued the study.||participants|||Number
654575|NCT01965262|Primary|Lens Surface - Debris - Hema-copolymer and Etafilcon A|Lens surface of debris for hema-copolymer and etafilcon A pair of lenses assessed at baseline. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=no debris present, 4=debris present more than two thirds of area beneath lens.|Baseline|All 30 subjects were dispensed lenses, and lens surface of debris measurements were obtained at baseline.||participants|||Number
654576|NCT01965262|Primary|Lens Surface - Deposition - Hema-copolymer and Etafilcon A|Lens surface of deposition for hema-copolymer and etafilcon A pair of lenses assessed at 1 week. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=absent, clean surface, 4= multiple deposits.|1 week|11 subjects discontinued the study.||participants|||Number
654577|NCT01965262|Primary|Lens Surface - Deposition - Hema-copolymer and Etafilcon A|Lens surface of deposition for hema-copolymer and etafilcon A pair of lenses assessed at baseline. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=absent, clean surface, 4= multiple deposits.|Baseline|All 30 subjects were dispensed lenses, and lens surface of deposition measurements were obtained at baseline.||participants|||Number
654578|NCT01965262|Primary|Biomicroscopy - Hema-copolymer and Etafilcon A|Biomicroscopy is analyzed for hema-copolymer and etafilcon A at 1 week. (Scale 0-4, 0=normal, 4=severe).|1 week|11 subjects discontinued the study.||units on a scale||Standard Deviation|Mean
654579|NCT01965262|Primary|Visual Acuity - Hema-copolymer and Etafilcon A|Visual acuity measured by logMAR for hema-copolymer and etafilcon A lenses assessed at 1 week.|1 week|11 subjects discontinued the study. Missing data of 1 subject for hema-copolymer group.||logMAR||Standard Deviation|Mean
654580|NCT01965262|Primary|Visual Acuity - Hema-copolymer and Etafilcon A|Visual acuity measured by logMAR of hema-copolymer and etafilcon A lenses assessed at baseline.|Baseline|All 30 subjects were dispensed lenses, and visual acuity measurements were obtained at baseline.||logMAR||Standard Deviation|Mean
654581|NCT01965158|Secondary|Change From Baseline to the Last 2 Weeks of the Treatment Period in the Number of Spontaneous Bowel Movements With No Straining Per Week|"A bowel movement and constipation assessment (BMCA) was completed by participants every day during the screening and treatment periods to record information about bowel movements (BMs) and constipation.
The severity of straining with each bowel movement was assessed on the following scale: 0=no straining, 1=mild straining, 2=moderate straining, 3=severe straining, 4=very severe straining. SBMs without straining were defined as SBMs with a straining score of 0."|Baseline and the last 2 weeks of the treatment period (Weeks 11 and 12 for participants who completed 12 weeks of treatment)|Intent-to-treat population||SBMs with no straining / week||Standard Error|Least Squares Mean
654582|NCT01965158|Secondary|Change From Baseline to the Last 2 Weeks of the Treatment Period in the Number of Complete Spontaneous Bowel Movements Per Week|A bowel movement and constipation assessment (BMCA) was completed by participants every day during the screening and treatment periods to record information about bowel movements (BMs) and constipation. A complete spontaneous bowel movement (CSBM) was defined as an SBM which was accompanied by the feeling of complete evacuation.|Baseline and the last 2 weeks of the treatment period (Weeks 11 and 12 for participants who completed 12 weeks of treatment)|Intent-to-treat population||complete spontaneous BMs / week||Standard Error|Least Squares Mean
654583|NCT01965158|Secondary|Change From Baseline to Week 1 in the Number of Spontaneous Bowel Movements Per Week|"A bowel movement and constipation assessment (BMCA) was completed by participants every day during the screening and treatment periods to record information about bowel movements (BMs) and constipation. An SBM was defined as a bowel movement that occurred without the use of a rescue laxative therapy during the 24 hours prior to the BM.
Baseline was defined as the 14 days in the screening period prior to study drug administration."|Baseline and Week 1|Intent-to-treat population||spontaneous bowel movements / week||Standard Error|Least Squares Mean
654584|NCT01965158|Secondary|Change From Baseline to the Last 2 Weeks of the Treatment Period in the Number of Spontaneous Bowel Movements Per Week|"A bowel movement and constipation assessment (BMCA) was completed by participants every day during the screening and treatment periods to record information about bowel movements (BMs) and constipation. An SBM was defined as a bowel movement that occurred without the use of a rescue laxative therapy during the 24 hours prior to the BM.
Baseline was defined as the 14 days in the screening period prior to study drug administration."|Baseline and the last 2 weeks of the treatment period (Weeks 11 and 12 for participants who completed 12 weeks of treatment)|Intent-to-treat population||spontaneous bowel movements / week||Standard Error|Least Squares Mean
654585|NCT01965158|Primary|Percentage of Participants With a Spontaneous Bowel Movement (SBM) Response|"A bowel movement and constipation assessment (BMCA) was completed by participants every day during the screening and treatment periods to record information about bowel movements (BMs) and constipation. An SBM was defined as a bowel movement that occurred without the use of rescue laxative therapy during the 24 hours prior to the BM.
A responder was defined as a participant having 9 or more positive response weeks out of the 12-week Treatment Period and 3 positive response weeks out of last 4 weeks of the 12-week Treatment Period. A positive response week was defined as ≥ 3 SBMs per week and an increase from baseline of ≥ 1 SBM per week for that week. If a participant had less than 4 days of diary entries for a week, that week was treated as a “non-response” week.
Any participant with insufficient primary endpoint data (data for less than 9 out of 12 weeks of the Treatment Period or less than 3 out of the last 4 weeks of the 12-week Treatment Period) was treated as a non-responder."|12-week treatment period|Intent-to-treat population||percentage of participants||95% Confidence Interval|Number
654586|NCT01965067|Secondary|Heart Rate|From the start of administration of sugammadex to recovery of the TOF ratio to 0.7 or 0.8 in both groups, Heart rate at 1 min before reversal(pre-reversal), 1 min after reversal(post-reversal), recovery and 1 day after surgery (post-anesthetic visit).|1 min before reversal, 1 min after reversal, 1 day after surgery|||beats/min||Standard Deviation|Mean
654587|NCT01965067|Secondary|Mean Arterial Blood Pressure|From the start of administration of sugammadex to recovery of the TOF ratio to 0.7 or 0.8 in both groups, mean arterial blood pressure at 1 min before reversal(pre-reversal), 1 min after reversal(post-reversal), recovery and 1 day after surgery (post-anesthetic visit).|1 min before reversal, 1 min after reversal, 1 day after surgery|||mmHg||Standard Deviation|Mean
654588|NCT01965067|Other Pre-specified|Adverse Events|adverse effect of sugammadex(hypersensitivity, dry mouth, hypertension etc.)|During 7days after operation|||participants|||Number
654589|NCT01965067|Other Pre-specified|Post-operative Nausea and Vomiting||During 7days after operation|||participants|||Number
654590|NCT01965067|Other Pre-specified|Incidence of Residual Neuromuscular Blockade||During 1day after operation|||participants|||Number
654591|NCT01965067|Primary|Reversal Time of Rocuronium|The time from the administration of sugammadex to recovery of the TOF ratio to 0.9 in deep neuromuscular block (1-2 twitches post-tetanic count) induced by rocuronium during mild hypothermia with core temperatures between 34.5°C and 35°C, and compared with the normal thermal condition.|The recovery time to the TOF ratio of 0.9 after the administration of the sugammadex, an expected average of 5 minutes|||seconds||Standard Deviation|Mean
654592|NCT01964976|Secondary|Change From Baseline in Fasting Insulin Level|The change between the fasting insulin value collected at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of biguanide treatment.|Baseline, Months 1, 3, 6, 12, and final assessment (up to Month 12)|The efficacy assessment population was defined as participants who completed the study and had fasting insulin data at baseline and post-baseline time points available.||microunits per milliliter||Standard Deviation|Mean
654593|NCT01964976|Secondary|Change From Baseline in Fasting Blood Glucose|The change between the fasting blood glucose value collected at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of the biguanide treatment.|Baseline, Months 1, 3, 6, 12, and final assessment (up to Month 12)|The efficacy assessment population was defined as participants who completed the study and had fasting blood glucose data at baseline and post-baseline time points available.||milligram per deciliter (mg/dL)||Standard Deviation|Mean
654594|NCT01964976|Secondary|Percentage of Participants of Achieving Objective Glycemic Control|The rate of achieving objective glycemic control in HbA1c level, was calculated at 12 month or final visit (last visit for a participant in the study, up to Month 12). Glycemic control was measured as <8.0%, <7.0%, and <6.0% of glycosylated hemoglobin. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of biguanide treatment.|Baseline and final assessment (up to Month 12)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.||percentage of participants|||Number
654595|NCT01964976|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of biguanide treatment.|Baseline, Months 1, 3, 6, 12, and final assessment (up to Month 12)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.||percentage of glycosylated hemoglobin||Standard Deviation|Mean
654596|NCT01964976|Primary|Number of Participants Reporting One or More Serious Adverse Drug Reactions|Serious adverse drug reactions are defined as serious adverse events (SAEs) which are in the investigator’s opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The safety analysis was planned to be assessed in alogliptin + biguanides and alogliptin + other arm separately.|Baseline up to 12 months|The safety analysis set was defined as all participants who completed the study and had safety data available.||participants|||Number
674022|NCT01656252|Secondary|Phase II- Red Blood Cell Transfusion Requirements|To determine the impact of eltrombopag on red blood cell transfusion requirements.|62 months||||||
654597|NCT01964976|Primary|Number of Participants Reporting One or More Adverse Drug Reactions|Adverse drug reactions are defined as adverse events (AEs) which are in the investigator’s opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. The safety analysis was planned to be assessed in alogliptin + biguanides and alogliptin + other arm separately.|Baseline up to 12 months|The safety analysis set was defined as all participants who completed the study and had safety data available.||participants|||Number
654598|NCT01964950|Secondary|Change From Baseline in Fasting Insulin Level|The change between the fasting insulin value collected at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of SU treatment.|Months 1, 3, 6, 12, and final assessment (up to Month 12)|The efficacy assessment population was defined as participants who completed the study and had fasting insulin data at baseline and post-baseline time points available.||micro units per milliliter (mcU/mL)||Standard Deviation|Mean
654599|NCT01964950|Secondary|Change From Baseline in Fasting Blood Glucose|The change between the fasting blood glucose value collected at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of the SU treatment.|Baseline, Months 1, 3, 6, 12, and final assessment (up to Month 12)|The efficacy assessment population was defined as participants who completed the study and had fasting blood glucose data at baseline and post-baseline time points available.||milligram per deciliter (mg/dL)||Standard Deviation|Mean
654600|NCT01964950|Secondary|Percentage of Participants Achieving Objective Glycemic Control|The rate of achieving objective glycemic control in HbA1c level was calculated at baseline and final visit (last visit for a participant in the study, up to Month 12). Glycemic control was measured as <8.0%, <7.0%, and <6.0% of glycosylated hemoglobin. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of SU treatment.|Baseline and final assessment (up to Month 12)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.||percentage of participants|||Number
654601|NCT01964950|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of SU treatment.|Baseline, Months 1, 3, 6, 12, and final assessment (up to Month 12)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.||percentage of glycosylated hemoglobin||Standard Deviation|Mean
654602|NCT01964950|Primary|Number of Participants Reporting One or More Serious Adverse Drug Reaction|Serious adverse drug reactions are defined as serious adverse events (SAEs) which are in the investigator’s opinion of causal relationship to the study treatment. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The safety analysis was planned to be assessed in alogliptin + SU and alogliptin + other arm separately.|Baseline up to 12 months|The safety analysis set was defined as all participants who completed the study and had safety data available.||participants|||Number
654603|NCT01964950|Primary|Number of Participants Reporting One or More Adverse Drug Reactions|Adverse drug reactions are defined as adverse events (AEs) which are in the investigator’s opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. The safety analysis was planned to be assessed in alogliptin + SU and alogliptin + other arm separately.|Baseline up to 12 months|The safety analysis set was defined as all participants who completed the study and had safety data available.||participants|||Number
654604|NCT01964898|Secondary|Negative Affect|As measured by the 10 item Positive Affect Negative Affect Scales (PANAS). The negative affect scale on the PANAS ranges from 5-25 with higher scores indicating greater negative affect in the past week. Adjusted for anti-depressant medication use and for cardiac rehabilitation attendance.|Baseline to 6 months|||units on a scale||Standard Error|Mean
654605|NCT01964898|Secondary|Positive Affect|As measured by the 10 item Positive Affect Negative Affect Scales (PANAS). The positive affect scale on the PANAS ranges from 5-25 with higher scores indicating greater positive affect in the past week. Adjusted for anti-depressant medication use and for cardiac rehabilitation attendance|Baseline to 6 months|||units on a scale||Standard Error|Mean
654606|NCT01964898|Secondary|Depression: 10 Item Center for Epidemiologic Studies Depression Scale (CESD)|The 10 item Center for Epidemiologic Studies Depression Scale ranges from 0-30 with higher scores indicating higher depression symptoms. Adjusted for anti-depressant medication use and for cardiac rehabilitation attendance.|Baseline to 6 months|||units on a scale||Standard Error|Mean
654607|NCT01964898|Secondary|Depression: 9 Item Patient Health Questionnaire (PHQ-9)|The 9 item Patient Health Questionnaire (PHQ-9) ranges from 0-27 with higher scores indicating higher depression symptoms. Adjusted for anti-depressant medication use and for cardiac rehabilitation attendance.|Baseline to 6 months|||units on a scale||Standard Error|Mean
654608|NCT01964898|Primary|Time to Smoking Lapse|Time in days to first lapse (i.e., first puff of a cigarette) after discharge, which were determined through timeline follow back interviewing. Results are adjusted for nicotine patch use and concurrent medication treatment targeting cessation.|6 months|||Days||Standard Error|Mean
654609|NCT01964898|Primary|Time to Smoking Relapse|Time in days to first relapse (i.e., smoking on 7 consecutive days or smoking in 2 consecutive 7 day periods), which were determined through timeline follow back interviewing. Results are adjusted for nicotine patch use and concurrent medication treatment targeting cessation.|6 months|||Days||Standard Error|Mean
654610|NCT01964898|Primary|Continuous Abstinence From Smoking Since Discharge|Results are adjusted for nicotine patch use and concurrent medication treatment targeting cessation.|6 months|||proportion of participants||95% Confidence Interval|Number
654611|NCT01964898|Primary|Smoking Cessation: 7 Day Point Prevalence Abstinence|No smoking, not even a puff, for 7 days; verified by carbon monoxide measurement. Results are adjusted for nicotine patch use and concurrent medication treatment targeting cessation.|6 months|||proportion of participants||95% Confidence Interval|Number
654612|NCT01964716|Secondary|Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series|Antibody geometric mean titers as measured by OPA assay for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented. GMTs were calculated using all participants with available data for the specified blood draw. CIs were back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the titers. Here “n”= participants evaluable =specified category.|1 month after the infant series|Evaluable immunogenicity population:participants who received vaccine (randomized) at all 3 doses, had blood drawn within protocol-specified time frames, had at least 1 valid and determinate assay result for proposed analysis, had no major protocol violations. OPA analysis was performed in a subset of randomly selected participants from each group.||titer||95% Confidence Interval|Geometric Mean
654613|NCT01964716|Secondary|Percentage of Participants Achieving a Serotype-Specific Opsonophagocytic Activity (OPA) Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series|Percentage of participants achieving OPA Titer >= lower limit of quantitation (LLOQ) along with 95% CI for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented. The LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43, Pn7F, 210; Pn09V, 345; Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; and Pn23F, 13. Exact 2-sided confidence interval (Clopper and Pearson) based on the observed proportion of participants. Here “n”= Number of participants with an antibody titer ≥ LLOQ for the given serotype.|1 month after the infant series|Evaluable immunogenicity population:participants who received vaccine (randomized) at all 3 doses, had blood drawn within protocol-specified time frames, had at least 1 valid and determinate assay result for proposed analysis, had no major protocol violations. OPA analysis was performed in a subset of randomly selected participants from each group.||percentage of participants||95% Confidence Interval|Number
654614|NCT01964716|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Prior to Dose 1|An AE was any untoward medical occurrence in a participants who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Adverse events were also reported in participants who provided consent but were not randomized in this study. The data of these participants has been reported under ‘Screened Only’ arm.|Informed consent up to Dose 1|Safety population: participants who received at least 1 dose of study vaccine. Here “N”= participants evaluable for this outcome measure.||participants|||Number
654615|NCT01964716|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) in the Infant Series|An AE was any untoward medical occurrence in a participants who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 to 42 days after last dose that were absent before treatment or that worsened relative to pretreatment state|Dose 1 up to 28 to 42 days after dose 3|Safety population included all participants who received at least 1 dose of study vaccine.||participants|||Number
654616|NCT01964716|Primary|Number of Participants Reporting Systemic Events Within 5 Days After Dose 3 in MDV and SDS Group|Systemic events (any fever greater than or equal to [>=] 38.0 degrees Celsius [C], decreased appetite was scaled as; Moderate (decreased oral intake); Severe (refusal to feed). Irritability scaled as; Mild (easily consolable); Moderate (requiring increased attention); Severe (Inconsolable, crying that cannot be comforted). Increased sleep was scale as; mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (Disabling not interested in usual daily activity) and use of antipyretic medication were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 5 days after Dose 3 (Day 2 to Day 6) of infant series|Safety population included participants who received at least 1 dose of study vaccine. ‘N’ (number of participants analyzed) included participants whose response was “Yes” for any day or “No” for all days. ‘n’ included participants whose response was “Yes” for any day or “No” for all days for specified systemic event.||participants|||Number
654617|NCT01964716|Primary|Number of Participants Reporting Systemic Events Within 5 Days After Dose 2 in MDV and SDS Group|Systemic events (any fever greater than or equal to [>=] 38.0 degrees Celsius [C], decreased appetite was scaled as; Moderate (decreased oral intake); Severe (refusal to feed). Irritability scaled as; Mild (easily consolable); Moderate (requiring increased attention); Severe (Inconsolable, crying that cannot be comforted). Increased sleep was scale as; mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (Disabling not interested in usual daily activity) and use of antipyretic medication were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 5 days after Dose 2 (Day 2 to Day 6) of infant series|Safety population included participants who received at least 1 dose of study vaccine. ‘N’ (number of participants analyzed) included participants whose response was “Yes” for any day or “No” for all days. ‘n’ included participants whose response was “Yes” for any day or “No” for all days for specified systemic event.||participants|||Number
654626|NCT01964547|Secondary|The Number of Patients With a Treatment-emergent Flag Using the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Course of the Study.|"Patients were scored at each clinic visit for the following outcomes using the C-SSRS: suicidal ideation, suicidal behaviour, suicidality (including complete suicidality). Possible flags were as follows: Wish to be Dead, Non-specific Active Suicidal Thoughts, Active Suicidal Ideation Without Intent, Active Suicidal Ideation With Intent, No Plan, Active Suicidal Ideation With Intent and Plan. The number of patients with a treatment-emergent flag is presented."|0-48 weeks|All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis.||participants|||Number
654618|NCT01964716|Primary|Number of Participants Reporting Systemic Events Within 5 Days After Dose 1 in MDV and SDS Group|Systemic events (any fever greater than or equal to [>=] 38.0 degrees Celsius [C], decreased appetite was scaled as; Moderate (decreased oral intake); Severe (refusal to feed). Irritability scaled as; Mild (easily consolable); Moderate (requiring increased attention); Severe (Inconsolable, crying that cannot be comforted). Increased sleep was scale as; mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (Disabling not interested in usual daily activity) and use of antipyretic medication were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 5 days after Dose 1 (Day 2 to Day 6) of infant series|Safety population included participants who received at least 1 dose of study vaccine. ‘N’ (number of participants analyzed) included participants whose response was “Yes” for any day or “No” for all days. ‘n’ included participants whose response was “Yes” for any day or “No” for all days for specified systemic event.||participants|||Number
654619|NCT01964716|Primary|Number of Participants Reporting Local Reaction Within 5 Days After Dose 3 in MDV and SDS Group|Local reactions were reported within 5 days (day 2 to day 6) using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurt if gently touched; Moderate (hurt if gently touched with crying); Severe (caused limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.1 to 7.0 cm); Severe (greater than [>] 7.0 cm). Participants may be represented in more than 1 category.|Within 5 days after Dose 3 (Day 2 to Day 6) of the infant series|Safety population included participants who received at least 1 dose of study vaccine. ‘N’ (number of participants analyzed) included participants whose response was “Yes” for any day or “No” for all days.||participants|||Number
654620|NCT01964716|Primary|Number of Participants Reporting Local Reaction Within 5 Days After Dose 2 in MDV and SDS Group|Local reactions were reported within 5 days (day 2 to day 6) using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurt if gently touched; Moderate (hurt if gently touched with crying); Severe (caused limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.1 to 7.0 cm); Severe (greater than [>] 7.0 cm). Participants may be represented in more than 1 category.|Within 5 days after Dose 2 (Day 2 to Day 6) of the infant series|Safety population included participants who received at least 1 dose of study vaccine. ‘N’ (number of participants analyzed) included participants whose response was “Yes” for any day or “No” for all days and 'n' = participants whose response was “Yes” for any day or “No” for all days for specified local reaction.||participants|||Number
654621|NCT01964716|Primary|Number of Participants Reporting Local Reaction Within 5 Days After Dose 1 in MDV and SDS Group|Local reactions were reported within 5 days (day 2 to day 6) using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurt if gently touched; Moderate (hurt if gently touched with crying); Severe (caused limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.1 to 7.0 cm); Severe (greater than [>] 7.0 cm). Participants may be represented in more than 1 category.|Within 5 days after Dose 1(Day 2 to Day 6) of the infant series|Safety population included participants who received at least 1 dose of study vaccine. ‘N’ (number of participants analyzed) included participants whose response was “Yes” for any day or “No” for all days.||participants|||Number
654622|NCT01964716|Primary|Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series for Each Vaccine Group|Antibody GMC for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw. CIs were back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations. Here “n”= participants with valid and determinate IgG concentration to the given serotype.|1 month after the infant series|Evaluable immunogenicity population: eligible participants who received vaccine (as randomized) at all 3 doses, had blood drawn within protocol-specified time frames, had at least 1 valid and determinate assay result for proposed analysis, had no major protocol violations.||microgram per milliliter (mcg/mL)||95% Confidence Interval|Geometric Mean
654623|NCT01964716|Primary|Percentage of Participants Achieving a Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal To (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series for Each Vaccine Group|Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented. Exact 2-sided confidence interval (Clopper and Pearson) based on the observed proportion of participants. Here “n”= participants with valid and determinate IgG concentration to the given serotype.|1 month after the infant series|Evaluable immunogenicity population: eligible participants who received vaccine (as randomized) at all 3 doses, had blood drawn within protocol-specified time frames, had at least 1 valid and determinate assay result for proposed analysis, had no major protocol violations.||percentage of participants||95% Confidence Interval|Number
654624|NCT01964547|Secondary|Incidence of Adverse Events as a Measure of Patient Safety.|The number of subjects who experienced an adverse event during the course of the study is presented.|0-50 weeks|All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis.||participants|||Number
654625|NCT01964547|Secondary|Change From Baseline to End of Treatment in Timed 10-meter Walk Times.|Only those patients for whom it was appropriate (i.e. ambulatory patients) were timed for how long it took to walk 10 metres. If a patient started the 10-meter walk but was unable to complete it, an estimated time for completion was calculated based on the available data. A negative difference from baseline indicates an improvement in condition.|0-48 weeks|All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis.||seconds||Standard Deviation|Mean
654678|NCT01963143|Secondary|Secondary Bioequivalence Analysis - Area Under the Curve Within a 21-Day Dosing Interval (AUC0-21) in Adult Subjects||After a minimum 5 infusions on each product, at pre-infusion, 10 minutes before end of infusion, 1, 3, 6, 24, 48 hours, 4, 7, 14 and 21 days post-infusion|||ratio Gammaplex 10%/Gammaplex 5%||90% Confidence Interval|Geometric Mean
654627|NCT01964547|Secondary|Change From Baseline to End of Treatment in Number of Visits to a Healthcare Professional.|At baseline, patients were asked how many times they had visited a healthcare professional in the previous 12 weeks. At subsequent visits, patients were asked how many times they had visited a healthcare professional since their last study visit. The change from baseline to the end of treatment is presented. A decrease in number indicates an improvement in condition.|0-48 weeks|All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis.||visits||Standard Deviation|Mean
654628|NCT01964547|Secondary|Change From Baseline to End of Treatment in Modified Ashworth Scale Total Score.|All 20 muscle groups were assessed for spasticity (using a 0-5 scale): 0= 'no increase in muscle tone' to 5= 'affected part(s) rigid in flexion or extension'. The score for all 20 muscle groups were added to give a total score out of 100. A decrease in score indicates an improvement in condition.|0-48 weeks|All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis.||units on a scale||Standard Deviation|Mean
654629|NCT01964547|Secondary|Physician's Global Impression of Change (PGIC) in the Severity of the Patient's Spasticity at the End of Treatment.|"Physicians were asked the following question to be rated on a seven-point scale:
How has the subject's spasticity changed since Visit 1? The markers were: Very much worse, Much worse, Minimally worse, No change, Minimally better, Much better, Very much better.
The number of patients for each of the markers is presented at the final study visit."|0-48 weeks|All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis.||participants|||Number
654630|NCT01964547|Secondary|Caregiver's Global Impression of Change (CGIC) in the Severity of the Patient's Spasticity at the End of Treatment.|"Caregivers were asked the following question to be rated on a seven-point scale:
How has the subject's spasticity changed since Visit 1? The markers were: Very much worse, Much worse, Minimally worse, No change, Minimally better, Much better, Very much better.
The number of patients for each of the markers is presented at the final study visit."|0-48 weeks|All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis.||participants|||Number
654631|NCT01964547|Secondary|Subject Global Impression of Change (SGIC) in the Severity of Their Spasticity at the End of Treatment.|"Patients were asked the following question, to be rated on a seven-point scale:
Please assess the change in your spasticity since immediately before receiving the first dose of study treatment (Visit 1) using the scale below.
The markers were: 'Very much worse', 'Much worse', 'Minimally worse', 'No change', 'Minimally better', 'Much better' or 'Very much better'.
The number of patients for each of the markers is presented at the final study visit."|0-48 weeks|All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis.||participants|||Number
654632|NCT01964547|Secondary|Change From Baseline to the End of Treatment in Beck Depression Inventory-II (BDI-II) Total Score.|The BDI-II is a multiple choice self-reported inventory that is one of the most widely used instruments for measuring the severity of depression. There are 21 questions or items, each having four possible responses. Each response is assigned a score ranging from zero to three, indicating the severity of the symptom. Items 1 to 13 assess symptoms that are psychological in nature, while items 14 to 21 assess symptoms that are more physical. The sum of all BDI-II item scores indicates the severity of depression. For patients eligible for this study, a score of 21 or over represents depression. The BDI-II can distinguish between different subtypes of depressive disorders, such as major depression and dysthymia. A reduction in score indicates an improvement in condition.|0-48 weeks|All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis.||units on a scale||Standard Deviation|Mean
654633|NCT01964547|Primary|Change From Baseline to the End of Treatment in Paced Auditory Serial Addition Test (PASAT) Total Score.|The PASAT is a measure of cognitive function that specifically assesses auditory information processing speed and flexibility, as well as calculation ability. Stimulus presentation rates were adapted for use with multiple sclerosis patients. The PASAT is presented on audio compact disk to control the rate of stimulus presentation. Single digits are presented either every 3 seconds (PASAT 1) or every 2 seconds (PASAT 2), and the patient must add each new digit to the one immediately prior to it. The test score is the sum of the total number of correct sums given (out of 60 possible) in each trial. An increase in score indicates an improvement in condition.|0-48 weeks|All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis.||units on a scale||Standard Deviation|Mean
654634|NCT01964352|Secondary|FVC AUC0-3h Response (Change From Baseline)|The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within−patient errors and Kenward−Roger approximation of denominator degrees of freedom.|baseline and 12 weeks|Patients from FAS||L||Standard Error|Mean
654635|NCT01964352|Secondary|TDI Focal Score|"This endpoint was evaluated based on the data from this individual trial and also based on the data from the combined dataset from this trial and the replicate study NCT02006732. The results for the combined dataset are included in the disclosure for NCT02006732 as specified in the analysis plan. Mahler Transitional Dyspnoea Index (TDI) focal score was performed to measure the effect of the treatment on patients' dyspnoea.(Rating scale of 3 components - change in functional impairment, change in magnitude of tasks, change in magnitude of efforts. Worst score = -9, best score = +9).
The adjusted mean (SE) are obtained from fitting an MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within−patient errors and Kenward−Roger approximation of denominator degrees of freedom."|12 weeks|Patients from FAS||Units on a scale||Standard Error|Mean
654679|NCT01963143|Primary|Primary Bioequivalence Analysis - Area Under the Curve Within a 28-day Dosing Interval (AUC0-28) in Adult Subjects||After a minimum 5 infusions on each product, at pre-infusion, 10 minutes before end of infusion, 1, 3, 6, 24, 48 hours, 4, 7, 14, 21 and 28 days post-infusion|PK population||ratio Gammaplex 10%/Gammaplex 5%||90% Confidence Interval|Geometric Mean
655227|NCT01954160|Secondary|24-hour Urine Sodium Excretion|Difference in 24-hour urine sodium excretion, compared between pre-RSD and 13 weeks after RSD.|13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.|||||
654636|NCT01964352|Secondary|Trough Forced Vital Capacity (FVC) Response (Change From Baseline)|Trough FVC was defined as the FVC value at the end of the dosing interval (24 hours). It was calculated as the mean of the 2 FVC measurements performed 23 h and at 23 h 50 min after inhalation of study medication at day 85. Trough FVC response was defined as trough FVC minus baseline FVC. The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within−patient errors and Kenward−Roger approximation of denominator degrees of freedom.|baseline and 12 weeks|Patients from FAS||L||Standard Error|Mean
654637|NCT01964352|Primary|St. George’s Respiratory Questionnaire (SGRQ) Total Score|"This endpoint was evaluated based on the data from this individual trial and also based on the data from the combined dataset from this trial and the replicate study NCT02006732. The results for the combined dataset are included in the disclosure for NCT02006732 as specified in the analysis plan. The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life).
The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within−patient errors and Kenward−Roger approximation of denominator degrees of freedom."|12 weeks treatment|Patients from FAS||units on a scale||Standard Error|Mean
654638|NCT01964352|Primary|Trough FEV1 Response (Change From Baseline)|Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours). It was calculated as the mean of the 2 FEV1 measurements performed 23 h and at 23 h 50 min after inhalation of study medication at day 85. Trough FEV1 response was defines as trough FEV1 minus baseline FEV1. The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within−patient errors and Kenward−Roger approximation of denominator degrees of freedom.|baseline and 12 weeks|Patients from FAS||L||Standard Error|Mean
654639|NCT01964352|Primary|FEV1 AUC0-3h Response|Forced expiratory volume in one second (FEV1) Area under the curve (AUC) 0-3h was calculated as the area under the FEV1-time curve from 0 to 3h post-dose using the trapezoidal rule, divided by the duration (3h) to report in litres. FEV1 AUC0-3h response was defined as FEV1 AUC0-3h minus baseline FEV1. The adjusted mean and standard error (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within−patient errors and Kenward−Roger approximation of denominator degrees of freedom.|baseline and 12 weeks|Patients from the Full Analysis Set (FAS): This patient set included all randomized and treated patients who had a baseline and at least one postbaseline measurement for any of the primary efficacy endpoints. The patient that entered the study with two different patient numbers was excluded from the FAS.||L||Standard Error|Mean
654640|NCT01964326|Secondary|"Percentage of Participants Who Stopped Study Medication Use and Asked a Doctor if They Experienced Any of the Labeled Stop Use and Ask a Doctor Symptoms"|Percentage of participants whose behavior was either correct or acceptable were considered to be compliant. The “Stop use and ask a doctor” symptoms included: (a) unexplained muscle pain or weakness or tenderness, (b) unusual fatigue, (c) loss of appetite (d) upper belly pain (e) dark-colored urine or (f) yellowing of the whites of eyes or skin. The behavior of the participants was considered correct if participants stopped use and contacted a doctor within 7 days after the event (symptom development).The behavior was considered acceptable if participants either stopped use or contacted a doctor (but did not do both) within the 7 days’ timeframe.|Day 1 up to Week 26|"The analysis was performed on the participants from the user set who experienced any of the labeled Stop use and ask a doctor symptoms."||Percentage of participants||95% Confidence Interval|Number
654641|NCT01964326|Secondary|"Percentage of Participants Taking an Ask a Doctor or Pharmacist Before Use Medication Who Followed the Labeling and Contacted a Doctor or Pharmacist Before Using Study Medication"|Percentage of participants whose behavior was either correct or acceptable were considered to be compliant. ‘Ask a doctor or pharmacist before use’ medication included human immunodeficiency virus (HIV) medicine, digoxin, telaprevir, rifampin, colchicine, or oral contraceptives. The behavior of the participants was considered correct if participants asked a doctor or pharmacist before use. The behavior was considered acceptable if participants contacted a doctor or pharmacist within 7 days of initiating therapy.|Day 1 up to Week 26|"The analysis was performed on the participants from the user set who reported the use of any Ask a doctor or pharmacist before use medication."||Percentage of participants||95% Confidence Interval|Number
654642|NCT01964326|Primary|Percentage of Participants Who Took Appropriate Action Based on Their LDL-C Results|Percentage of participants whose behavior was either correct or acceptable were considered to be compliant. The behavior was considered correct if participants self-reported an LDL-C level below 130 milligram per deciliter (mg/dL) or normal, or low and decided to continue with atorvastatin OTC or if participants self-reported an LDL-C below 130 mg/dL, or normal, or low but stopped the use because of new conditions preventing them from continuing use. The behavior was considered acceptable if participants self-report LDL-C level between 130 and 135 mg/dL and continued to use atorvastatin OTC without contacting a physician or other health care practitioner or if participants self-reported LDL-C greater than or equal to (>=) 130 mg/dL('borderline high' or 'high' LDL-C), and contacted a physician after getting the LDL-C test results.|Day 1 up to Week 26|The analysis was performed on continuing users who checked their LDL-C during the study.||Percentage of participants||95% Confidence Interval|Number
654643|NCT01964326|Primary|Percentage of Participants Who Complied With the Direction to Check Their Low-density Lipoprotein Cholesterol (LDL-C) Level|Percentage of participants whose behavior was either correct or acceptable were considered to be compliant. The behavior was considered correct if participants had their LDL-C checked between Weeks 4 and 12. The behavior was considered acceptable if participants had their LDL-C checked between Weeks 2 and 3 (before Week 4) or between Weeks 13 (after Week 12) and 26 or if participants were instructed by a physician that an LDL-C test was not needed.|Day 1 up to Week 26|The analysis was performed on the continuing users set which is a subset of the users set, defined as the users who continued taking the study medication for at least 6 weeks since the first date of the study treatment.||Percentage of participants||95% Confidence Interval|Number
654644|NCT01964222|Secondary|Attitudes About Cancer Clinical Trials|A questionnaire will be administered to assess outcomes of interest immediately after showing the participant either the decision aid (DA) about clinical trials or the Siteman Cancer Center website about clinical trials. The questionnaire will include two items in which participants rank their intent to participate in a cancer clinical trial and their intent to encourage others to participate in a cancer clinical trial on a 5-point scale with higher numbers indicating greater intent. Participation in study concludes upon completion of questionnaire.|1 day (Immediately following either showing the participant the experimental or control information (same day)|Analysis is represented as mean (standard deviation) of participant-reported intent.||units on a scale of 1 to 5||Standard Deviation|Mean
654645|NCT01964222|Primary|Uncertainty in Choice|A questionnaire will be administered to assess outcomes of interest immediately after showing the participant either the decision aid (DA) about clinical trials or the Siteman Cancer Center website about clinical trials. The questionnaire will include the Uncertainty Subscale to evaluate decisional conflict. The subscale includes two items from the ten-item Low Literacy Decisional Conflict Scale, each with three response categories. The combined score on the two items will be divided by 2 and multiplied by 25 to produce an overall “uncertainty” score from 0 to 100. Higher values represent more uncertainty. Participation in study concludes upon completion of questionnaire.|1 day Immediately following either showing the participant the experimental or control information (same day)|Analysis is represented as mean (standard deviation) of calculated uncertainty.||units on a scale of 0 to 100||Standard Deviation|Mean
654646|NCT01964222|Primary|Clarity of Values|A questionnaire will be administered to assess outcomes of interest immediately after showing the participant either the decision aid (DA) about clinical trials or the Siteman Cancer Center website about clinical trials. The questionnaire will include the Values Clarity Subscale to evaluate decisional conflict. The subscale includes two items from the ten-item Low Literacy Decisional Conflict Scale, each with three response categories. The combined score on the two items will be divided by 2 and multiplied by 25 to produce an overall “values clarity” score from 0 to 100. Higher values represent less clarity. Participation in study concludes upon completion of questionnaire.|1 day (Immediately following either showing the participant the experimental or control information (same day)|Analysis is represented as mean (standard deviation) of calculated values clarity.||units on a scale of 0 to 100||Standard Deviation|Mean
654647|NCT01964222|Secondary|Self-efficacy for Communicating About Cancer Clinical Trials|A questionnaire will be administered to assess outcomes of interest immediately after showing the participant either the decision aid (DA) about clinical trials or the Siteman Cancer Center website about clinical trials. The questionnaire will include an item in which participants rank their self-efficacy for finding information about cancer clinical trials on a 5-point scale with higher numbers indicating greater self-efficacy. Participation in study concludes upon completion of questionnaire.|1 day (Immediately following either showing the participant the experimental or control information (same day)|Analysis is represented as mean (standard deviation) of participant-reported self-efficacy for finding information about cancer clinical trials.||units on a scale of 1 to 5||Standard Deviation|Mean
654648|NCT01964222|Primary|Knowledge About Cancer Clinical Trials|"A questionnaire will be administered to assess outcomes of interest immediately after showing the participant either the decision aid (DA) about clinical trials or the Siteman Cancer Center website about clinical trials. The questionnaire will include eleven knowledge items such as Only very sick patients are asked to take part in a cancer research study and Cancer research studies almost never involve the use of a placebo or sugar pill alone. Participants will indicate each item as True, False, or I don't know. An overall knowledge composite score will be created with the average percentage of items participants in each condition correctly answer. Participation in study concludes upon completion of questionnaire."|1 day (Immediately following either showing the participant the experimental or control information (same day)|Analysis is represented as mean (standard deviation) of percentage of knowledge questions answered correctly.||percentage questions answered correctly||Standard Deviation|Mean
654649|NCT01963845|Secondary|HOMA-IR, Homeostatic Model Assessment of Insulin Resistance|HOMA-IR, calculated as [(glucose (mg/dL) X insulin (mg/dL)) / 405 ] at baseline and 24 weeks|Baseline and 24 weeks|All participants with HOMA-IR calculated at baseline and 24 weeks||HOMA-IR score||Inter-Quartile Range|Median
654650|NCT01963845|Secondary|LDL, Low-density Lipoprotein|LDL, measured in mg/dL at baseline and 24 weeks|Baseline and 24 weeks|All participants with LDL measurements at baseline and 24 weeks||mg/dL||Inter-Quartile Range|Median
654651|NCT01963845|Secondary|ALT, Alanine Aminotransferase|ALT, measured in IU/L at baseline and 24 weeks|Baseline and 24 weeks|All participants with ALT measurements at baseline and 24 weeks||IU/L||Inter-Quartile Range|Median
654652|NCT01963845|Secondary|AST, Aspartate Aminotransferase|AST, measured in IU/L at baseline and 24 weeks|Baseline and 24 weeks|All participants with AST measurements at baseline and 24 weeks||IU/L||Inter-Quartile Range|Median
654653|NCT01963845|Primary|Percentage Change in Liver Fat Relative to Baseline Assessed by MRI-PDFF|Participants liver fat was measured at baseline and 24 weeks. This is the percentage change in liver fat assessed by MRI-PDFF and stratified by treatment group.|Baseline and 24 weeks|||percentage change in liver fat||Standard Deviation|Mean
654654|NCT01963767|Secondary|Cognitive Performance|The secondary endpoint will be improvement in cognitive performance over the two-month follow-up period on the paper and pencil tests of cognitive ability. The test that was used here is the Identical Pictures test, from the Educational Testing Services battery (Ekstrom RB, French JW, Harman HH, Dermen D. Manual for kit of factor referenced cognitive tests. Educational Testing Service, Princeton, NJ, 1976.). This test evaluates the number of pictures that persons can match within a 90 second period. There are two trials at 90 seconds and the maximum score is 48 matches (minimum is 0). Higher scores indicate better performance because participants are able to make more matches within the 90 second interval. This test provides an index of processing speed, the ability to do a task rapidly.|Measured at baseline and two months|||units on a scale||Standard Error|Mean
654680|NCT01963091|Secondary|Likert Scale Rating of Subjective Craving|Subjects will rate craving on 10-point Likert scale before and after drug administration and stress task with 0 being 'not at all' and 10 being 'extremely'|0 mintues post 15 minute stress task|||units on a scale||Standard Deviation|Mean
654681|NCT01963091|Secondary|Likert Scale Rating of Subjective Stress|Subjects will rate subjective stress on 10-point Likert scale with 0 being 'not at all' and 10 being 'extremely'|0 minutes post 15 minute stress task|||units on a scale||Standard Deviation|Mean
654655|NCT01963767|Primary|Delay Eyeblink Conditioning|"Participants will be tested on eyeblink classical conditioning at the USF Health Byrd Alzheimer's Institute. Participants will receive 60 trials of eyeblink conditioning at the two-month follow-up point. Participants watch an entertaining silent video (e.g., Milo and Otis). The airpuff is delivered through a nozzle held in front of the participant and blink latency is recorded.
The outcome measure is an index of the percentage of eyeblinks that are made to a tone (conditioned stimulus) after the learning period is complete. The percentage can range from 0% (no conditioned learning has occurred) to 100% (all responses are conditioned; Woodruff-Pak, D. S. (2001). Eyeblink classical conditioning differentiates normal aging from Alzheimer's disease. Integrative Physiological and Behavioral Science, 36(2), 87-108.)."|Measured at the end of the intervention period, which is two months after initiation of the placebo of NT-020 doses|From the 105 persons with complete data on the second outcome, only 102 had complete data on this outcome. The three who did not contribute to this analysis were because there were two equipment failures and one person had a glass eye and the procedure could not be performed.||percentage of conditioned responses||Standard Deviation|Mean
654656|NCT01963676|Secondary|Persistence of Decrease in AHRS Score Over Time|We will re-assess patients one month after the completion of stimulation to evaluate whether their change from baseline to day 5 score on the AHRS persisted over time, namely 30 days.|Day 5, One month|Per protocol; All participants who completed every session of the study from the initial session through the one month follow-up.||units on a scale||Standard Deviation|Mean
654657|NCT01963676|Primary|Change in Auditory Hallucination Rating Scale (AHRS)Score From Baseline to Day 5|Examining AHRS total score after 5 days of stimulation compared to baseline assessment total.|Baseline, Day 5|Per protocol; All participants who completed every session of the study from the initial session through the one month follow-up.||units on a scale||Standard Deviation|Mean
654658|NCT01963611|Secondary|Mean Change From Baseline in Brain Volume Per Subject|Change from baseline in brain volume per subject was calculated using 5 series MRI scan.|Baseline, Weeks 24, 28, 32, 36, 40|The Outcome Measure was not derived due to early termination of the study.|||||
654659|NCT01963611|Secondary|Time to First Relapse|Relapse was defined as new, worsening or recurrent neurological symptoms attributed to multiple sclerosis that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days. These new or worsening symptoms should be noted by the patient and must be accompanied by at least one of the following: An increase of greater than or equal to (>=) 1 grade in >=2 functional scales of the Expanded Disability Status Scale (EDSS) or an increase of >=2 grades in 1 functional scale of the EDSS or an increase of >= 0.5 or an increase of >=1.0 in EDSS if the previous EDSS was 0.|Baseline up to Week 40|The Outcome Measure was not derived due to early termination of the study.|||||
654660|NCT01963611|Secondary|Mean Change From Baseline in Volume of T2 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan|Change from baseline per subjects in volume of T2 Gd-enhancing lesions was calculated using 5 series MRI scan.|Baseline, Weeks 12, 24, 28, 32, 36, 40|ITT analysis set included all randomized subjects with at least 1 post-baseline efficacy (MRI) assessment. Here 'n' signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively.||cubic millimeter (mm^3)||Standard Deviation|Mean
654661|NCT01963611|Secondary|Mean Change From Baseline in Volume of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan|Change from baseline in volume of T1 Gd-enhancing lesions per subject was calculated using 5 Serial MRI Scans.|Baseline, Weeks 12, 24, 28, 32, 36, 40|ITT analysis set included all randomized subjects with at least 1 post-baseline efficacy (MRI) assessment. Here 'n' signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively.||cubic millimeter (mm^3)||Standard Deviation|Mean
654662|NCT01963611|Secondary|Mean Number of New, Unenhancing T1 Lesions (Black Holes) Per Subject and Scan|New, unenhancing T1 lesions (Black Holes) per subject and scan was calculated using 5 Serial MRIs.|Weeks 12, 24, 28, 32, 36, 40|ITT analysis set included all randomized subjects with at least 1 post-baseline efficacy (MRI) assessment. Here 'n' signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively.||lesions/subject/scan||Standard Deviation|Mean
654663|NCT01963611|Secondary|Mean Number of New or Enlarging Time Constant 2 (T2) Lesions Per Subject and Scan|New or enlarging Time Constant 2 (T2) lesions per subject and scan was calculated using 5 serial MRI scans.|Weeks 12, 24, 28, 32, 36,40|ITT analysis set included all randomized subjects with at least 1 post-baseline efficacy (MRI) assessment. Here 'n' signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively.||lesions/subject/scan||Standard Deviation|Mean
654664|NCT01963611|Secondary|Mean Number of New T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan|T1 Gd-enhancing lesions per subject and scan was measured using 5 serial MRI scans.|Weeks 12, 24, 28, 32, 36, 40|"ITT analysis set included all randomized subjects with at least 1 post-baseline efficacy (MRI) assessment. Here n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."||lesions/subject/scan||Standard Deviation|Mean
654665|NCT01963611|Secondary|Percentage of Subjects Remaining Relapse-Free|Relapse was defined as new, worsening or recurrent neurological symptoms attributed to multiple sclerosis that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days. These new or worsening symptoms should be noted by the patient and must be accompanied by at least one of the following: An increase of greater than or equal to (>=) 1 grade in >=2 functional scales of the Expanded Disability Status Scale (EDSS) or an increase of >=2 grades in 1 functional scale of the EDSS or an increase of >= 0.5 or an increase of >=1.0 in EDSS if the previous EDSS was 0.|Baseline up to Week 40|Safety Analysis Set (SAF) includes all randomized subjects who had received at least 1 dose of investigational medicinal product (IMP).||percent subjects|||Number
654682|NCT01963091|Primary|Salivary Cortisol Levels|salivary cortisol|0 minutes post 15 minute stress task|||mg/dl||Standard Deviation|Mean
654696|NCT01962922|Primary|Evaluation of C(Max) for Envarsus XR and IR-Tac|"Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate C(max). Arithmetic mean and standard deviation is given below.
Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours."|Day 7|For this outcome measuure the Protocol PK population of N = 46 was used.||ng/mL||Standard Deviation|Mean
654666|NCT01963611|Secondary|Mean Annualized Relapse Rate (ARR)|Relapse was defined as new, worsening or recurrent neurological symptoms attributed to multiple sclerosis that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days. These new or worsening symptoms should be noted by the patient and must be accompanied by at least one of the following: An increase of greater than or equal to (>=) 1 grade in >=2 functional scales of the Expanded Disability Status Scale (EDSS) or an increase of >=2 grades in 1 functional scale of the EDSS or an increase of >= 0.5 or an increase of >=1.0 in EDSS if the previous EDSS was 0. Annualized Relapse Rate was calculated as = 365.25 x (Number of relapses during Treatment Period) per (Number of days on treatment during Treatment Period).|Baseline up to Week 40|Safety Analysis Set (SAF) includes all randomized subjects who had received at least 1 dose of investigational medicinal product (IMP).||percent relapse||Standard Deviation|Mean
654667|NCT01963611|Primary|Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan|Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions per Subject and Scan was calculated using 5 serial magnetic resonance imaging (MRI) scans.|Baseline , Week 12, 24, 28, 32, 36, 40|Intent to Treat (ITT) analysis set included all randomized subjects with at least 1 post-baseline efficacy (MRI) assessment. Here 'n' signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively.||lesions per subjects per scan||Standard Deviation|Mean
654668|NCT01963403|Other Pre-specified|Bleeding Patterns and Number of Participants With Bleeding Improvement|"Bleeding improvement in women who received placebo but opted for open-label treatment after first cycle
Bleeding improvement over the 84 days of study participation
Bleeding patterns in placebo vs. combined oral contraceptive users"|Evaluated at follow up visits at 1 month and, if subject continues after 1st month, again at 3 months|||Participants|||Count of Participants
654669|NCT01963403|Other Pre-specified|Number of Participants withTreatment Success or Failure|"Treatment success will be measured by desire to continue treatment because the initial treatment made the bleeding better.
Partial failure of the study treatment will be measured by the desire to continue treatment because the initial treatment did not work
Complete failure of treatment will be measured by the desire to:
discontinue treatment because it did not work; no further treatment requested
ETG implant removal
Desire to use non-study treatment"|Evaluated at follow up visits at 1 month and, if subject continues after 1st month, again at 3 months|one month evaluation; 1 subject LTFU at one month in each group||Participants|||Count of Participants
654670|NCT01963403|Secondary|Number of Participants With Adverse Events|Participants will be evaluated for adverse events while using a combined oral contraceptive with ETG implant.|Adverse events will be evaluated at each contact (visits at 1 and 3 months, phone contact at 2 months) with the participant|Outcomes at one month; 1 person LTFU at one month in each group||Participants|||Count of Participants
654671|NCT01963403|Primary|Number of Participants With Bleeding Improvement|Bleeding improvement will be measured by participant response to the question of whether she feels her bleeding is improved and she is satisfied with the treatment.|Bleeding improvement will be evaluated during first cycle of study treatment (28 days)|1 person in each group LTFU at one month, which was the primary outcome||Participants|||Count of Participants
654672|NCT01963260|Secondary|Maximum Concentration (Cmax) of MK-8723 Among Healthy Participants and Participants With ITP|Serum samples for determination of Cmax were collected at pre-specified time-points.|All dose groups: Predose and 4 (end of infusion), 6, 12, 24 hrs postdose and Days 3, 4, 5, 7, 10, 14, 21, 28; 30 mg/kg and 100 mg/kg dose groups: Days 43, 56, 71, 84|The per protocol population consisting of all participants in compliance with the protocol (e.g., availability of measurements, absence of major protocol violations) was used for this pharmacokinetic (Cmax) analysis.||μg/mL||Geometric Coefficient of Variation|Geometric Mean
654673|NCT01963260|Secondary|Area Under the Concentration-time Curve of MK-8723 From Time 0 to Infinity (AUC0-∞) Among Healthy Participants and Participants With ITP|AUC0-∞ is a measure of total body exposure to drug. Serum samples for determination of AUC0-∞ were collected at pre-specified time-points.|All dose groups: Predose and 4 (end of infusion), 6, 12, 24 hrs postdose and Days 3, 4, 5, 7, 10, 14, 21, 28; 30 mg/kg and 100 mg/kg dose groups: Days 43, 56, 71, 84|The per protocol population consisting of all participants in compliance with the protocol (e.g., availability of measurements, absence of major protocol violations) was used for the pharmacokinetic (AUC0-∞) analysis.||hr*μg/mL||Geometric Coefficient of Variation|Geometric Mean
654674|NCT01963260|Primary|Number of Participants With a Positive Platelet Response to MK-8723|In participants with ITP, platelet response is a rapid, sensitive, and highly qualitative measure of response to anti-inflammatory therapy. A positive platelet response was defined as: 1) A doubling of platelet counts at the time point of maximum response (through Day 14) as compared to Day 0 AND an increase to an absolute level of ≥50,000/μL in participants with a baseline platelet count of <50,000/μL, OR 2) A 50% increase in the platelet count at the time point of maximum response (through Day 14) as compared to Day 0 in participants with a baseline platelet count of ≥50,000/μL. The analysis was specified only for participants with ITP (Part 2) that received treatment with MK-8723 or matching placebo.|Up to Day 14|The per protocol population consisting of all participants in compliance with the protocol (e.g., availability of measurements, absence of major protocol violations) was used for the pharmacodynamic (platelet response) analysis.||Participants|||Number
654675|NCT01963260|Primary|Number of Participants Discontinuing Study Due to an Adverse Event (AE)|An AE is defined as any unfavorable and unintended medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 84 Days|The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis.||Participants|||Number
654676|NCT01963260|Primary|Number of Participants Experiencing an Adverse Event|An AE is defined as any unfavorable and unintended medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 84 days|The All Participants as Treated (APaT) population consisting of all participants who received at least one dose of study drug was used for the safety analysis.||Participants|||Number
654677|NCT01963143|Secondary|Secondary Bioequivalence Analysis - IgG Trough Levels||After a minimum 5 infusions on each product, at pre-infusion.|||ratio Gammaplex 10%/Gammaplex 5%||90% Confidence Interval|Geometric Mean
654683|NCT01962974|Secondary|Percentage of Participants Who Acheived ACR 20 Response at Week 24 With Trough Infliximab Levels Below the Lower Limit of Quantification (LLOQ)|The ACR 20 Response is defined as >= 20 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=20 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS (010 millimeter [mm], 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and ESR.|Week 24|Due to early study termination, data for this outcome measure was not collected and therefore the analyses could not be conducted.|||||
654684|NCT01962974|Secondary|Percentage of Participants Who Achieved an ACR 20 Response at Week 24 With Confirmed Presence of Antibodies to Infliximab|The ACR 20 Response is defined as >= 20 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=20 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS (010 millimeter [mm], 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and ESR.|Week 24|Due to early study termination, data for this outcome measure was not collected and therefore the analyses could not be conducted.|||||
654685|NCT01962974|Primary|Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20) Response at Week 24|The ACR 20 Response is defined as greater than or equal to (>=) 20 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=20 percent improvement in 3 of following 5 assessments: patient's assessment of pain using Visual Analog Scale (VAS; 0-10 millimeter [mm], 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and erythrocyte sedimentation rate (ESR).|Week 24|Due to early study termination, data for this outcome measure was not collected and therefore the analyses could not be conducted.|||||
654686|NCT01962961|Primary|Change in Flow-mediated Dilation (FMD) of the Brachial Artery|Measure of endothelial function|Baseline and 8 weeks|Analysis population includes those who completed the 8 week trial and had both baseline and week 8 values available.||Percentage of vessel diameter||Standard Deviation|Mean
654687|NCT01962961|Primary|Change in Circulating F2-isoprostane Levels|Oxidative stress measure|Baseline and 8 weeks|Analysis population includes those who completed the 8 week trial and had both baseline and week 8 values available.||pg/mL||Standard Deviation|Mean
654688|NCT01962961|Primary|Change in Circulating Malondialdehyde Levels|Measure of oxidative stress|Baseline and 8 weeks|Analysis population includes those who completed the 8 week trial and had both baseline and week 8 values available.||micromolar||Standard Deviation|Mean
654689|NCT01962922|Primary|Evaluation of C(Min) for Envarsus XR and IR-Tac|"Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate AUC(0-24). Arithmetic mean and standard deviation is given below.
Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours."|Day 21|For this outcome measure the Protocol PK population N= 46 was used.||ng/mL||Standard Deviation|Mean
654690|NCT01962922|Primary|Evaluation of C(Max) for Envarsus XR and IR-Tac|"Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate C(max). Arithmetic mean and standard deviation is given below.
Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours."|Day 21|For this outcome measuure the Protocol PK population of N = 46 was used.||ng/mL||Standard Deviation|Mean
654691|NCT01962922|Primary|Evaluation of AUC(0-24) for Envarsus XR and IR-Tac|"Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate AUC(0-24). Arithmetic mean and standard deviation is given below.
Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours."|Day 21|For this outcome measure the PK population N=46 was used.||ng*hr/mL||Standard Deviation|Mean
654692|NCT01962922|Primary|Evaluation of C(Min) for Envarsus XR and IR-Tac|"Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate AUC(0-24). Arithmetic mean and standard deviation is given below.
Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours"|Day 14|For this outcome measuure the Protocol PK population N= 46 was used.||ng/mL||Standard Deviation|Mean
654693|NCT01962922|Primary|Evaluation of C(Max) for Envarsus XR and IR-Tac|"Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate C(max). Arithmetic mean and standard deviation is given below.
Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours."|Day 14|For this outcome measuure the Protocol PK population of N = 46 was used.||ng/mL||Standard Deviation|Mean
654694|NCT01962922|Primary|Evaluation of AUC(0-24) for Envarsus XR and IR-Tac|"Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate AUC(0-24). Arithmetic mean and standard deviation is given below.
Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours."|Day 14|For this outcome measure the PK population N=46 was used||ng*hr/mL||Standard Deviation|Mean
654695|NCT01962922|Primary|Evaluation of C(Min) for Envarsus XR and IR-Tac|"Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate AUC(0-24). Arithmetic mean and standard deviation is given below.
Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours."|Day 7|For this outcome measure the Protocol PK population N= 46 was used.||ng/mL||Standard Deviation|Mean
654697|NCT01962922|Primary|Evaluation of AUC(0-24) for Envarsus XR and IR-Tac|"Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate AUC(0-24). Arithmetic mean and standard deviation is given below.
Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours."|Day 7|For this outcome measure the PK population N=46 was used.||ng*hr/mL||Standard Deviation|Mean
654698|NCT01962675|Secondary|Change From Baseline Score on Toe Tap Test|Measuring the Time required to perform toe taps|Two times, 1) Baseline, and 2) Up to 1 hour after intervention.|Study was to be PhD student dissertation. PI left institution. Months later PhD student withdrew without notice. Data were stored on computers and not accessible to PI. Computers were replaced by new lab director.|||||
654699|NCT01962675|Secondary|Change From Baseline Scores of a 10 m Walk Test|Change from baseline score of the time required to perform 10 m walking.|Two times, 1) Baseline, and 2) Up to 1 hour after intervention.|Study was to be PhD student dissertation. PI left institution. Months later PhD student withdrew without notice. Data were stored on computers and not accessible to PI. Computers were replaced by new lab director.|||||
654700|NCT01962675|Primary|Change From Baseline Active Motor Threshold|Measuring Active motor threshold using single pulse transcranial magnetic stimulation (TMS) of Motor cortex M1 area|Two times, 1) Baseline, and 2) Up to 1 hour after intervention.|Study was to be PhD student dissertation. PI left institution. Months later PhD student withdrew without notice. Data were stored on computers and not accessible to PI. Computers were replaced by new lab director.|||||
654701|NCT01962675|Primary|Change From Baseline Midswing Ankle ROM|Measuring Ankle range of motion (ROM) first at Baseline and then up to 1 hour after intervention at the Midswing phase during Gait.|Two times, 1) Baseline, and 2) Up to 1 hour after intervention.|Study was to be PhD student dissertation. PI left institution. Months later PhD student withdrew without notice. Data were stored on computers and not accessible to PI. Computers were replaced by new lab director.|||||
654702|NCT01962493|Secondary|Overall Gingival and Interproximal MLSI at Week 6|An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 6 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score).|Week 6 post treatment administration|The efficacy analysis was performed on the Intent-to-treat (ITT) population which consisted of all participants who were randomized and received the study treatment and completed one of the post-baseline efficacy assessments.||Score on a Scale||Standard Deviation|Mean
654703|NCT01962493|Secondary|Overall Gingival and Interproximal MLSI at Week 3|An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 3 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score).|Week 3 post treatment administration|The efficacy analysis was performed on the Intent-to-treat (ITT) population which consisted of all participants who were randomized and received the study treatment and completed one of the post-baseline efficacy assessments.||Score on a Scale||Standard Deviation|Mean
654704|NCT01962493|Secondary|Overall Interproximal MLSI at Week 6|An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 6 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score).|Week 6 post treatment administration|The efficacy analysis was performed on the Intent-to-treat (ITT) population which consisted of all participants who were randomized and received the study treatment and completed one of the post-baseline efficacy assessments.||Score on a Scale||Standard Deviation|Mean
654705|NCT01962493|Secondary|Overall Interproximal MLSI at Week 3|An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 3 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score).|Week 3 post treatment administration|The efficacy analysis was performed on the Intent-to-treat (ITT) population which consisted of all participants who were randomized and received the study treatment and completed one of the post-baseline efficacy assessments.||Score on a Scale||Standard Deviation|Mean
654706|NCT01962493|Secondary|Overall Facial MLSI at Week 6|An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 6 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score).|Week 6 post treatment administration|The efficacy analysis was performed on the Intent-to-treat (ITT) population which consisted of all participants who were randomized and received the study treatment and completed one of the post-baseline efficacy assessments.||Score on a Scale||Standard Deviation|Mean
654736|NCT01960842|Secondary|Number of Participants With Potentially Clinically Significant Values for 12-lead Electrocardiogram (ECG)|Terms abbreviated in the table include heart rate (HR) in beats per minute (bpm), PR interval (PRI), QT interval corrected for heart rate using Bazett's formula (QTcB), QT interval corrected for heart rate using Fridericia's formula (QTcF), and baseline (BL). Increase and decrease are signified by ↑ and ↓, respectively. n = the number of participants with available data at each time point.|From Baseline (end of screening period) to Final PEG-J Visit (up to week 12)|Safety analysis set.||participants|||Number
654707|NCT01962493|Secondary|Overall Facial MLSI at Week 3|An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 3 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score).|Week 3 post treatment administration|The efficacy analysis was performed on the Intent-to-treat (ITT) population which consisted of all participants who were randomized and received the study treatment and completed one of the post-baseline efficacy assessments.||Score on a Scale||Standard Deviation|Mean
654708|NCT01962493|Secondary|Overall MLSI at Week 3|An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 3 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score).|Week 3 post treatment administration|The efficacy analysis was performed on the Intent-to-treat (ITT) population which consisted of all participants who were randomized and received the study treatment and completed one of the post-baseline efficacy assessments.||Score on a Scale||Standard Deviation|Mean
654709|NCT01962493|Primary|Modified Lobene Stain Index (MLSI) at Week 6|An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 6 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score).|Week 6 post treatment administration|The efficacy analysis was performed on the Intent-to-treat (ITT) population which consisted of all participants who were randomized and received the study treatment and completed one of the post-baseline efficacy assessments.||Score on a Scale||Standard Deviation|Mean
654710|NCT01962441|Secondary|Percentage of Participants Experiencing Viral Relapse|Viral relapse is defined as HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement.|Up to Posttreatment Week 24|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants|||Number
654711|NCT01962441|Secondary|Percentage of Participants Experiencing On-Treatment Virologic Failure|"On-treatment virologic failure was defined as:
Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)"|Up to 24 weeks|Full Analysis Set||percentage of participants|||Number
654712|NCT01962441|Secondary|Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12||Baseline; Weeks 1, 2, 4, 8, and 12|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
654713|NCT01962441|Secondary|HCV RNA at Weeks 1, 2, 4, 8, and 12||Weeks 1, 2, 4, 8, and 12|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
654714|NCT01962441|Secondary|Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24||Weeks 1, 2, 4, 8, 12, 16, 20, and 24|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants|||Number
654715|NCT01962441|Secondary|Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set||percentage of participants|||Number
654716|NCT01962441|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 24 weeks|Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug.||percentage of participants|||Number
654717|NCT01962441|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug.||percentage of participants|||Number
654718|NCT01962428|Secondary|Bleeding Events||follow-up for 28 days after the loading dose of ticagrelor||||||
654719|NCT01962428|Secondary|Platelet Reactivity Index (PRI) Measured by VASP-P||0.5hour,1hour,8hours,24hours after the loading dose of ticagrelor||||||
654720|NCT01962428|Primary|Platelet Reactivity Index(PRI) Measured by VASP-P|Vasodilator-stimulated phosphoprotein(VASP) phosphorylation, a measure of P2Y12 receptor reactivity, was determined by flow cytometry with the use of the Platelet VASP-FCM Kit (Stago, France)and recorded as the platelet reactivity index (PRI).|2 hours after the loading dose of ticagrelor|||percentage of 100||Inter-Quartile Range|Median
654721|NCT01961544|Secondary|Disease Control Rate (DCR)|DCR is defined as the number of participants with complete response (CR), partial response (PR), and stable disease (SD). The Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 was used to assess the tumor response. Tumor response was evaluated by investigators. CR is defined as the disappearance of all extranodal target lesions. All pathological lymph nodes must have decreased to <10 millimeters (mm) in the short axis. PR is defined as at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline sum diameters. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (SLD increased by at least 20% from the smallest value on study [including baseline, if that is the smallest]. The SLD must also demonstrate an absolute increase of at least 5 mm. [Two lesions increasing from 2 mm to 3 mm, for example, does not qualify]).|mean of 3.76 months|Full Analysis Set: participants who were administered investigational product at least once after enrollment and had at least one primary efficacy data value since Baseline||Participants|||Number
654722|NCT01961544|Primary|Number of Participants With Any Treatment-emergent Adverse Event (TEAE) and Any Treatment-emergent Serious Adverse Event (SAE)|An AE is defined as any harmful, untoward sign (including abnormal laboratory value, etc.), symptom, or disease in a participant administered investigational product that does not necessarily have a causal relationship with treatment. An SAE is defined as an AE that is life threatening or results in death, results in hospitalization (initial or prolonged), results in a disability (significant, persistent, or permanent change, impairment, damage or disruption in the participant's body function/structure, physical activities, or quality of life), results in a congenital anomaly, or requires intervention to prevent permanent impairment or damage. TEAEs are defined as those events that started on or after the date and time of administration of the first dose of study drug and those events that were present prior to the administration of the first dose of study drug and increased in severity during the study.|mean of 3.76 months|Safety Set: all participants who are administered investigational product at least once for the analysis||Participants|||Number
654723|NCT01961349|Primary|Achivement of Target Sedation|The target sedation is defined as MOAA/S (Modified Observer's Assessment of Alertness/Sedation) scores 2 to 4 for ≥50% of all MOAA/S measurements from scope-in to scope-out.|from scope-in to scope-out|FAS (Full Analysis Set)||% of patients||95% Confidence Interval|Number
654724|NCT01961349|Secondary|PSSI Total Score|PSSI (Statistics of Patient Satisfaction with Sedation Instrument) total score obtained from 20 questions (1 to 7 points for each) adjusted to have range of 0 ( very dissatisfied: all items scored with 1 point) to 100 (very satisfied: all items scored with 7 points)|at 24-48 h after endoscopy|FAS (Full Analysis Set)||Score on a scale (0 - 100)||Standard Deviation|Mean
654725|NCT01961271|Secondary|Secondary Efficacy Outcome -- Incidence of Early Treatment Discontinuation Due to Lack of Efficacy.||From time of enrolment to Visit 6 (ie. up to119 days from enrolment)|||participants|||Number
654726|NCT01961271|Secondary|Secondary Efficacy Outcome on Physicians' and Patients' Treatment Satisfaction Assessed Using Physician's Global Impression of Change Scale and Patient's Global Impression of Change Scale Respectively|"The overall assessment of the change in pain intensity from baseline is measured at Visit 6.
Physician's Global Impression of Change scale: Investigator's opinion on a scale of 1 to 7 where 1 is very much improved and 7 is very much worse Patient's Global Impression of Change scale: Subject's opinion on a scale of 1 to 7 where 1 is very much improved and 7 is very much worse"|At visit 6 (anywhere between Day 91 to 119 after enrolment depending on how long titration took)|||units on a scale||Standard Deviation|Mean
654727|NCT01961271|Secondary|Secondary Efficacy Outcome as Measured by Number of Subjects Requiring at Least 1 Breakthrough (Rescue) Pain Medication|Daily use of breakthrough pain medication from visits 1-6, assessed from patient diaries.|Approximately 17 weeks starting from enrolment|||participants|||Number
654728|NCT01961271|Secondary|Treatment-emergent Adverse Events (TEAE's) as Measured by Number of Subjects With at Least 1 TEAE|Side effects of the transdermal patch treatment will be analysed.|From time of enrolment up to 7 days after completion / discontinuation visit (up to 140 days)|||participants|||Number
654729|NCT01961271|Secondary|Secondary Efficacy Outcome Determined by Change in Percentage of Subjects Who Met Criteria on EQ5D-3L Quality of Life Questionnaire From Pre- to Post-intervention|"Pre-intervention: Visit 1 Post-intervention: Visit 6
There are 5 dimensions in the EQ5D-3L questionnaire answered by the subjects, classified into 5 categories here:
Mobility -- change in % of subjects who have no problem in walking around Self-care -- change in % of subjects who have no problem in self-care Usual activities -- change in % of subjects who have no problem with performing their usual activities Pain/ discomfort -- change in % of subjects who do not experience pain or discomfort Anxiety/ depression -- change in % of subjects who do not feel anxious or depressed"|approximately 17 weeks starting from enrolment|||percentage of subjects|||Number
654730|NCT01961271|Primary|Efficacy According to BS-11 Pain Score Reduction|"The primary efficacy outcome analysis is the pre- and post-intervention change in BS-11 pain score. The reduction in scores were calculated by subtracting the post-intervention score from the baseline score.
BS-11 is known as Box scale-11; it is an 11-point scale measuring pain intensity. It ranges from 0 to 10, whereby 0 represents no pain and 10 represents the worst imaginable pain. Subjects selected a number based on the pain intensity they were feeling at that time."|Maximum 17 weeks starting from enrolment|Subjects of the analysis population met the eligibility criteria. It consists of subjects who completed the study and who withdrew for any reason.||units on a scale||Standard Deviation|Mean
654731|NCT01960907|Post-Hoc|Difference of Hospitalization Rate|Difference between the hospitalization rate during the study and the previous year. For each patient, hospitalization rate was defined as the number of hospital admissions during a period divided by the length (in days) of the period. Number of hospitalizations was collected by the hospital clinical records.|Baseline and 9 months|||hospitalizations/year/patient||Inter-Quartile Range|Median
654732|NCT01960907|Primary|Final Utility Index of EQ-5D Questionnaire|The quality of life of patients as quantified by the final utility index of the EQ-5D questionnaire. The utility index ranges from -0.074 to 1 with 1 being the highest possible quality of life.|9 months|An intention to treat analysis has been applied for the primary outcomes of the trial. Multiple Imputation (MI) was used to assign values were data were missing. However for a limited number of patient, due to the fact that all data were missing, we couldn't apply any imputation method and therefore they have been excluded.||units on a scale||Standard Deviation|Mean
654733|NCT01960907|Primary|Time to First Hospitalization|It represents the number of days, since the enrolment into the study, to the first hospitalization|From enrolment up to 9 months|An intention to treat analysis has been applied for the primary outcomes of the trial and all the randomized patients have been retained for the analysis.||days||Inter-Quartile Range|Mean
654734|NCT01960842|Other Pre-specified|Physical Examination|Any abnormal findings are recorded as an adverse event after the first study drug administration; please see the AE section below. Further analysis for physical examination findings was not performed per protocol.|From Baseline (end of screening period) to Final PEG-J Visit (up to week 12)||||||
654735|NCT01960842|Other Pre-specified|Neurological Examination|Any abnormal findings are recorded as an adverse event after the first study drug administration; please see the AE section below. Further analysis for neurological examination findings was not performed per protocol.|From Baseline (end of screening period) to Final PEG-J Visit (up to week 12)||||||
655228|NCT01954160|Secondary|Urine Volume|Urine volume following furosemide therapy after sodium loading.|13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.|||||
654737|NCT01960842|Secondary|Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters|Terms abbreviated in the table include upper limit of normal (ULN), male (m), and female (f).|From Baseline (end of screening period) to Final PEG-J Visit (up to week 12)|Safety analysis set.||participants|||Number
654738|NCT01960842|Secondary|Number of Participants With Potentially Clinically Significant Values for Hematology Parameters|Terms abbreviated in the table include females (f), males (m), and femtoliters (fL).|From Baseline (end of screening period) to Final PEG-J Visit (up to week 12)|Safety analysis set.||participants|||Number
654739|NCT01960842|Secondary|Number of Participants With Potentially Clinically Significant Vital Sign Parameters|Terms abbreviated in the table include supine systolic blood pressure (SuSBP), standing systolic blood pressure (StSBP), orthostatic systolic blood pressure (OSBP), supine diastolic blood pressure (SuDBP), standing diastolic blood pressure (StDBP), orthostatic diastolic blood pressure (ODBP), supine pulse (SuP) in beats per minute (bpm), standing pulse (StP), body temperature (Temp), and baseline (BL). Increase and decrease are signified by ↑ and ↓, respectively.|From Baseline (end of screening period) to Final PEG-J Visit (up to week 12)|Safety analysis set.||participants|||Number
654740|NCT01960842|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs)|"An adverse event (AE) is any untoward medical occurrence in a participant which does not necessarily have a causal relationship with this treatment. A serious AE (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent AEs (TEAEs) are defined as any event that began or worsened in severity after N-J placement. The investigator assessed the relationship of each event to the use of study drug as Reasonable Possibility or No Reasonable Possibility.
For more details on adverse events please see the AE section below."|From N-J placement to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days.|Safety Analysis Set: All subjects who had undergone the N-J placement procedure.||participants|||Number
654741|NCT01960842|Secondary|Average Daily Normalized “Off” Time at Baseline and Each Visit: Change From Baseline To The Final PEG-J Visit|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. n= the number of participants with available data at each time point."|Baseline (end of screening period) and Weeks 2, 4, 6, 8, 10, and 12|All participants in the FAS with available data.||hours||Standard Deviation|Mean
654742|NCT01960842|Secondary|Average Daily Normalized “Off” Time Including All PD Diaries Regardless if They Were Completed After the Subject Had Used a Concomitant Anti-Parkinsonian Medication: Change From Baseline To The Final PEG-J Visit|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Negative change from baseline for off time indicates improvement."|Baseline (end of screening period) and Final PEG-J Visit (up to week 12)|All participants in the FAS with available data.||hours||Standard Deviation|Mean
654743|NCT01960842|Secondary|Average Daily Normalized “Off” Time Excluding Subjects Who Did Not Receive LCIG During the Entire PEG-J Period: Change From Baseline To The Final PEG-J Visit|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Negative change from baseline for off time indicates improvement."|Baseline (end of screening period) and Final PEG-J Visit (up to week 12)|All participants in the FAS with available data.||hours||Standard Deviation|Mean
654744|NCT01960842|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score: Change From Baseline To The Final PEG-J Visit|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part IV Score is the sum of the answers to the 11 questions that comprise Part IV, each of which are measured on a 5-point scale (0-4) or a 2-point scale (0 or 1). The Part IV score ranges from 0 to 23 and higher scores are associated with more disability.|Baseline (end of screening period) and Final PEG-J Visit (up to week 12)|All participants in the FAS.||units on a scale||Standard Deviation|Mean
654745|NCT01960842|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score: Change From Baseline To The Final PEG-J Visit|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part I Score is the sum of the answers to the 4 questions that comprise Part I, each of which are measured on a 5-point scale (0-4). The Part I score ranges from 0 to 16 and higher scores are associated with more disability.|Baseline (end of screening period) and Final PEG-J Visit (up to week 12)|All participants in the FAS.||units on a scale||Standard Deviation|Mean
654746|NCT01960842|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) Total Score: Change From Baseline To The Final PEG-J Visit|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The total score is the sum of the responses to the 31 questions (44 answers) that comprise Parts I-III of the scale. The total score will range from 0 to176, with 176 representing the worst (total) disability, and 0 representing no disability.|Baseline and Final PEG-J Visit (up to Week 12)|All participants in the FAS.||units on a scale||Standard Deviation|Mean
654756|NCT01960816|Post-Hoc|NOSE Score at 90-day Follow-up|The Nasal Obstruction Symptom Evaluation (NOSE) scale is a validated disease-specific health status outcomes instrument, used to assess severity of nasal obstruction symptoms. Score ranges from 0 to 100. Higher scores indicate increased symptoms/symptom severity. Each subject's NOSE score at the 90-day follow-up was compared to that subject's baseline NOSE score to determine change in nasal obstruction symptoms.|90 days|Subjects with 90-day follow-up data||units on a scale||Standard Deviation|Mean
654747|NCT01960842|Secondary|Parkinson's Disease Questionnaire (PDQ-39) Mobility, Emotional Well-Being, Stigma, Social Support, Cognition, Communication, and Bodily Discomfort Domain Scores: Change From Baseline To The Final PEG-J Visit|The PDQ-39 is a self-administered questionnaire which comprises 39 items (each question answered on a 5-point scale) addressing 8 domains of health in Parkinson's disease patients: Mobility (e.g., fear of falling when walking) includes 10 questions; Emotional Well-being (e.g., feelings of isolation) includes 6 questions; Stigma (e.g., social embarrassment) includes 4 questions; Social Support includes 3 questions; Cognition includes 4 questions; Communication includes 3 questions; and Bodily Discomfort includes 3 questions. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline (end of screening period) and Final PEG-J Visit (up to week 12)|All participants in the FAS.||units on a scale||Standard Deviation|Mean
654748|NCT01960842|Secondary|"Average Daily Normalized On Time With Troublesome Dyskinesia: Change From Baseline To The Final PEG-J Visit"|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Positive change from baseline for on time indicates improvement."|Baseline (end of screening period) and Final PEG-J Visit (up to week 12)|All participants in the FAS with available data.||hours||Standard Deviation|Mean
654749|NCT01960842|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) Part IIl Score: Change From Baseline To The Final PEG-J Visit|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part III score is the sum of the 27 answers provided to the 14 Part III questions, each of which are measured on a 5-point scale (0-4). The Part III score ranges from 0-108 and higher scores are associated with more disability.|Baseline (end of screening period) and Final PEG-J Visit (up to week 12)|All participants in the FAS.||units on a scale||Standard Deviation|Mean
654750|NCT01960842|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score: Change From Baseline To The Final PEG-J Visit|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part II score is the sum of the answers to the 13 questions that comprise Part II, each of which are measured on a 5-point scale (0-4). The Part II score ranges from 0-52 and higher scores are associated with more disability.|Baseline (end of screening period) and Final PEG-J Visit (up to week 12)|All participants in the FAS.||units on a scale||Standard Deviation|Mean
654751|NCT01960842|Secondary|Patient Global Impression of Change (PGI-C) Score at the Final PEG-J Visit|"The PGI-C is a 7-point response scale. The subjects were to rate their change in status from Screening Visit 1 using the following 7-point scale: 1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6 = Much worse, 7 = Very much worse. The responses of Minimally improved, Much improved, and Very much improved on the PGI-C were used to define responders."|Final PEG-J Visit (up to week 12)|All participants in the FAS with available data.||units on a scale||Standard Deviation|Mean
654752|NCT01960842|Secondary|Clinical Global Impression - Change (CGI-I) Score at the Final PEG-J Visit|The CGI-I is a global assessment by the Investigator of the change in clinical status since the start of treatment. The CGI-I ratings are as follows: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse.|Final PEG-J Visit (up to week 12)|All participants in the FAS with available data.||units on a scale||Standard Deviation|Mean
654753|NCT01960842|Secondary|Parkinson's Disease Questionnaire (PDQ-39) Summary Index: Change From Baseline To The Final PEG-J Visit|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The PDQ-39 Summary Index is the sum of all answers divided by the highest score possible (i.e. number of answers multiplied by 4) which is multiplied by 100 to put the score on a 0-100 scale. Higher scores are associated with more severe symptoms.|Baseline (end of screening period) and Final PEG-J Visit (up to week 12)|All participants in the FAS.||units on a scale||Standard Deviation|Mean
654754|NCT01960842|Secondary|"Average Daily Normalized On Time Without Troublesome Dyskinesia: Change From Baseline To The Final PEG-J Visit"|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Positive change from baseline for on time indicates improvement."|Baseline (end of screening period) and Final PEG-J Visit (up to week 12)|All participants in the FAS with available data.||hours||Standard Deviation|Mean
654755|NCT01960842|Primary|Average Daily Normalized “Off” Time: Change From Baseline To The Final PEG-J Visit|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Negative change from baseline for off time indicates improvement."|Baseline (end of screening period) and Final PEG-J Visit (up to week 12)|All participants in the Full Analysis Set (FAS; all enrolled participants who received at least 1 dose of LCIG infusion during the PEG-J Period and had data for baseline and at least 1 post-PEG-J efficacy assessment) with available data.||hours||Standard Deviation|Mean
654757|NCT01960816|Primary|Technical Feasibility as Assessed by the Ability of the InFlux Device to Deliver RF Energy to Target Tissue|Ability of the InFlux device to deliver RF energy at the selected power setting, and to reach and maintain the selected target temperature.|Procedure, up to 1 hour (average, 16 minutes)|All enrolled subjects underwent the procedure.||participants|||Number
654758|NCT01960816|Primary|Incidence of Unanticipated Serious Adverse Device Effects|The study will be considered to have met its primary safety endpoint if no subject experiences an unanticipated serious adverse device effect (USADE defined as any serious adverse effect caused by, or associated with, the investigational device, that was not previously identified in nature, severity, or degree of incidence in the protocol)|90 Days|One subject was lost-to-follow-up prior to the 90-day follow-up visit. Therefore, 32 subjects were available for analysis at the 90-day time point.||events|||Number
654759|NCT01960725|Other Pre-specified|Serious Adverse Event Assessment|Proportions of subjects in each vaccine group reporting an adverse event in the period following each dose and any dose of RV5 will be determined|After each dose and up to 10 months post-vaccination|||Proportion of participants|||Number
654760|NCT01960725|Other Pre-specified|Adverse Event Assessment|Proportions of subjects in each vaccine group reporting an adverse event in the period following each dose and any dose of RV5 will be determined|28 days after each dose, up to 10 months post-vaccination|||Proportion of participants|||Number
654761|NCT01960725|Other Pre-specified|Reactogenicity Assessment|Proportions of subjects in each vaccine group reporting a reactogenicity event in the period following each dose and any dose of RV5 will be determined|7 days after each dose, up to 10 months post-vaccination|Proportions of subjects in each vaccine group reporting a reactogenicity event in the period following each dose and any does of RV5 will be determined||Proportion of participants|||Number
654762|NCT01960725|Other Pre-specified|Serum Rotavirus Immunoglobulin A|Post dose 3 serum rotavirus Immunoglobulin A geometric mean titer (GMT)|1 month following vaccine series completion|The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all scheduled study vaccinations, and who contributed post-vaccination blood samples for testing for which valid results were reported.||titers||95% Confidence Interval|Geometric Mean
654763|NCT01960725|Secondary|P1 Serum-neutralizing Antibody|Post dose 3 P1 serum-neutralizing antibody(SNA) geometric mean titer (GMT)|1 month following vaccine series completion|The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all scheduled study vaccinations, and who contributed post-vaccination blood samples for testing for which valid results were reported.||titers||95% Confidence Interval|Geometric Mean
654764|NCT01960725|Secondary|G4 Serum-neutralizing Antibody|Post dose 3 G4 serum-neutralizing antibody(SNA) geometric mean titer (GMT)|1 month following vaccine series completion|The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all scheduled study vaccinations, and who contributed post-vaccination blood samples for testing for which valid results were reported.||titers||95% Confidence Interval|Geometric Mean
654765|NCT01960725|Secondary|G3 Serum-neutralizing Antibody|Post dose 3 G3 serum-neutralizing antibody(SNA) geometric mean titer (GMT)|1 month following vaccine series completion|The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all scheduled study vaccinations, and who contributed post-vaccination blood samples for testing for which valid results were reported.||titers||95% Confidence Interval|Geometric Mean
654766|NCT01960725|Secondary|G2 Serum-neutralizing Antibody|Post dose 3 G2 serum-neutralizing antibody(SNA) geometric mean titer (GMT)|1 month following vaccine series completion|The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all scheduled study vaccinations, and who contributed post-vaccination blood samples for testing for which valid results were reported.||titers||95% Confidence Interval|Geometric Mean
654767|NCT01960725|Primary|G1 Serum-neutralizing Antibody|Post dose 3 G1 serum-neutralizing antibody (SNA) geometric mean titer (GMT)|1 month following vaccine series completion|The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all scheduled study vaccinations, and who contributed post-vaccination blood samples for testing for which valid results were reported.||titers||95% Confidence Interval|Geometric Mean
654768|NCT01960530|Primary|AUC0-t|Derived PK for Serum Cortisol: Area under the curve from 0-24 hours|Hourly from 0 to 24 hours|All randomised subjects who received no IMP (no treatment), dexamethasone, oral Infacort®, hydrocortisone tablet and i.v. hydrocortisone, had sufficient serum cortisol concentration by time profiles and who did not violate the protocol||nmol*h/L||Standard Deviation|Geometric Mean
654769|NCT01960530|Secondary|PK and Metabolism of Cortisol|Blood: Serum cortisol under physiological conditions and after administration of dexamethasone and Infacort® Granules, Hydrocortisone Tablets and i.v Hydrocortisone Injection.|Blood, urine & saliva samples on Day 1 and/or Day 2 of each Study Period|||nmol/L||Standard Deviation|Mean
654770|NCT01960530|Secondary|Insulin Sensitivity Under Physiological Conditions and After Administration of Dexamethasone and Infacort®, Hydrocortisone Tablets and i.v Hydrocortisone.|A standardised mixed meal elevates blood glucose and provides a reproducible stimulation of insulin release. Lower levels of insulin secretion, whilst maintaining normoglycaemia would indicate enhanced insulin sensitivity and glucose disposal; higher insulin levels will reflect insulin resistance.|Blood samples on Day 1 and/or Day 2 of each Study Period|||uIU/mL||Standard Deviation|Mean
654771|NCT01960530|Secondary|Concentrations of Cortisol Binding Protein|Cortisol protein binding under physiological conditions and after the administration of dexamethasone and hydrocortisone.|Blood samples on Day 1 and/or Day 2 of each Study Period|||ug/mL||Standard Deviation|Mean
654772|NCT01960530|Secondary|Adverse Events (AEs)|Number of subjects with adverse events throughout the study.|Days 1-2 during each Study Period|||participants|||Number
654773|NCT01960530|Primary|Maximum Serum Concentration (Cmax)|Derived PK for Serum Cortisol: Maximum serum concentration (Cmax)|Hourly from 0 to 24 hours|All randomised subjects who received no IMP (no treatment), dexamethasone, oral Infacort®, hydrocortisone tablet and i.v. hydrocortisone, had sufficient serum cortisol concentration by time profiles and who did not violate the protocol||nmol/L||Standard Deviation|Geometric Mean
654774|NCT01960400|Secondary|State Anxiety|The State-Trait Anxiety Inventory (STAI) was used to assess the state of anxiety at the moment (Spielberg et al., 1983). The total score is obtained by adding the scores for all 20 questions range from 20 to 80; the higher the result is, the higher is the anxiety about an event.|Before (T0) and after treatment (6 weeks) (T1)|||units on a scale||Standard Deviation|Mean
654821|NCT01959503|Secondary|Proportion of Subjects Who Achieve Immediate Hemostasis, Defined as 0 Seconds, at All Treated Aortic Anastomotic Suture Lines Following Assigned Treatment.||0 seconds to 10 minutes|||percentage of participants|||Number
654775|NCT01960400|Secondary|Kinesiophobia|The Tampa Scale of kinesiophobia (TSK) (Kori et al., 1990) was used to assess fear of movement and injury/(re)injury. The TSK questionnaires consist of 17 items. Each item, composed of a statement, is scored by the patient on a 4-point Likert scale of 1 (strongly disagree) to 4 (strongly agree). The total scores range from 17 to 68, with higher scores representing stronger fear-avoidance beliefs (Clark, Kori, Brockel, 1996).|Before (T0) and after treatment (6 weeks) (T1)|||units on a scale||Standard Deviation|Mean
654776|NCT01960400|Secondary|Pain Catastrophizing|"The Pain catastrophizing scale (PCS) (Sullivan et al., 1995) was used to evaluate the feelings, thoughts, and emotions related to pain catastrophizing of the patient. The PCS instructions ask participants to reflect on past painful experiences, and to indicate the degree to which they experienced each of 13 thoughts or feelings when experiencing pain, on 5-point scales with the end points (0) not at all and (4) all the time. The PCS yields a total score and three subscale scores assessing rumination, magnification and helplessness.
* The scores ranging from 0 to 52 points (sum of the tree subscales), with higher scores representing stronger pain catastrophizing (Sullivan et al., 1995)."|Before (T0) and after treatment (6 weeks) (T1)|||units on a scale||Standard Deviation|Mean
654777|NCT01960400|Primary|Pain Severity|"The choice of outcome measures was performed in accordance with Initiative on Methods, Measurement and Pain Assessment in Clinical Trials (IMMPACT) guidelines (Dworkin et al., 2005). All instruments were used before (T0) and after 6 weeks of treatment (T1).
The primary outcome measure was pain severity as measured with the Brief pain inventory short-form (BPI-sf) (Poundja et al., 2007). The BPI-sf includes four questions on pain levels, where subjects were asked to rate intensity on a scale of 0 (no pain) to 10 (worst possible pain) for: (1) pain at its worst in the last 24 hours; (2) pain at its least in the last 24 hours; (3) pain on average in the last 24 hours; (4) pain right now. The total score ranges from 0 to 40 (sum of the four subscales). The higher the score, the greater the severity of the pain is severe."|Before (T0) and after treatment (6 weeks) (T1)|||units on a scale||Standard Deviation|Mean
654778|NCT01960387|Secondary|Predictive Factors for Response to Treatment.|Evaluation of potential factors that are predictive of clinical response in newly diagnosed Acute Myeloid Leukemia patients treated with Clofarabine (40mg/m^2/Day) + Cytarabine (1g/m^2/Day).|Up to 1 year|Results data are not available due to low/insufficient subject accrual from early [trial] termination.|||||
654779|NCT01960387|Secondary|Relapse Free Survival|Number of months of relapse free survival for newly diagnosed Acute Myeloid Leukemia patients treated with Clofarabine (40mg/m^2/Day) + Cytarabine (1g/m^2/Day).|Up to 24 months|Results data are not available due to low/insufficient subject accrual from early [trial] termination.|||||
654780|NCT01960387|Secondary|Overall Survival|Number of months of survival for newly diagnosed Acute Myeloid Leukemia patients treated with Clofarabine (40mg/m^2/Day) + Cytarabine (1g/m^2/Day).|Up to 24 months|Results data are not available due to low/insufficient subject accrual from early [trial] termination.|||||
654781|NCT01960387|Primary|Complete Clinical Response|Number of patients with newly diagnosed Acute Myeloid Leukemia who achieved Complete Response to therapy as determined by bone marrow biopsy evaluation. A CR designation required that the patient achieved a morphologic leukemia-free state and an absolute neutrophil count greater than or equal to 1.0 x 10^9/l, a platelet count greater than or equal to 100 x 10^9/l, and no evidence of extramedullary disease.|Between 14 and 28 days from start of study treatment|Newly diagnosed Acute Myeloid Leukemia patients who received clofarabine (1-2 hour intravenous infusion of 40mg/m2 daily dose) plus cytarabine (2-4 hours maximum intravenous infusion of 1g/m2 daily dose) starting 3-4 hours post completion of clofarabine administration on days 1 through 5, who were evaluable for response by bone marrow biopsy.||participants|||Number
654782|NCT01960296|Secondary|Development of Myocardial Infarction or Thrombosis||up to 90 days|||participants|||Number
654783|NCT01960296|Secondary|Same Day Discharged|Number of patients discharged on the day of surgery|up to 90 days|||participants|||Number
654784|NCT01960296|Secondary|Average Length of Hospital Stay||up to 90 days|||days||Standard Deviation|Mean
654785|NCT01960296|Secondary|Average Change in Hematocrit|hematocrit levels change from preoperative to postoperative|baseline and Day 1|||percent change||Standard Deviation|Mean
654786|NCT01960296|Secondary|Procedure Time||Day 1|||minutes||Standard Deviation|Mean
654787|NCT01960296|Primary|Perioperative Bleeding Complications|Development of perioperative bleeding complications as indicated for need for blood transfusions, hematoma, and bleeding requiring re-operation.|up to 90 days postop|||participants|||Number
654788|NCT01960296|Secondary|Procedure Estimated Blood Loss||up to 90 days postop|Quantitative estimation of blood loss was available in 31 of the 43||mL||Standard Deviation|Mean
654789|NCT01960296|Primary|Bleeding-related Re-hospitalization|Perioperative Bleeding Complications as indicated by bleeding requiring re-admission.|up to 90 days post op|||participants|||Number
654790|NCT01960140|Primary|PK: Area Under the Concentration Versus Time Curve From Zero to Infinity [AUC(0-∞)] of Simvastatin and Simvastatin Acid|The AUC(0-∞) of simvastatin (a CYP3A substrate) and its active acid metabolite (simvastatin acid) is reported.|Period 1, Day 1 and Period 2, Day 6: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 and 48 hours postdose|Participants who received study drug (simvastatin in Period 1 and at least 1 dose of baricitinib and simvastatin in Period 2) and had evaluable PK data.||nanograms*hour/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
654791|NCT01960140|Primary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of Simvastatin and Simvastatin Acid|The Cmax of simvastatin [a cytochrome P450 (CYP) 3A substrate] and its active acid metabolite (simvastatin acid) is reported.|Period 1, Day 1 and Period 2, Day 6: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 and 48 hours postdose|Participants who received study drug (simvastatin in Period 1 and at least 1 dose of baricitinib and simvastatin in Period 2) and had evaluable PK data.||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
654792|NCT01960114|Secondary|Patient Global Evaluation|Patient Assessment of the pain medication - Number of subjects rating the medication they received as a pain reliever on a score of 0-4, where 0=poor, 1=fair, 2=good, 3=very good, 4=excellent.|12 Hours|Analysis was based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||percentage of participants|||Number
654793|NCT01960114|Secondary|Duration of Pain Relief|Minutes until rescue medication was given.|Within 12 Hours|Analysis was based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||Minutes||95% Confidence Interval|Median
654794|NCT01960114|Secondary|Time to Meaningful Pain Relief|Minutes until meaningful pain relief was achieved. Stopwatch was started after the subject took the study medication. The subjects were instructed to stop the stopwatch when the relief from the starting pain was meaningful to them.|Within 12 Hours|Analysis was based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||Minutes||95% Confidence Interval|Median
654795|NCT01960114|Secondary|Time to Confirmed First Perceptible Pain Relief|Minutes until confirmed first perceptible pain relief was achieved. Stopwatch was started after the subject took the study medication. The subject was instructed to stop the stopwatch when they first began to feel any pain relief. The first perceptible pain relief was confirmed if the subject also stopped the second stopwatch indicating meaningful pain relief.|Within 12 Hours|Analysis was based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||Minutes||95% Confidence Interval|Median
654796|NCT01960114|Primary|Time Weighted Sum of Pain Intensity Difference (PID) Over 10 Hours (SPID 0-10)|Time weighted sum of pain intensity difference scores from baseline over 10 hours. Pain intensity was evaluated using a 0-10 numerical rating scale (NRS) where 0 = no pain and 10 = very severe pain. SPID 0-10 = 0.25 x (PID at 15 min + PID at 30 min + PID at 45 min + PID at 60 min + PID at 75 min + PID at 90 min) + 0.5 x (PID at 120 min) + PID at 3 h + PID at 4 h + PID at 5 h + PID at 6 h + PID at 7 h + PID at 8 h + PID at 9 h + PID at 10 h.|10 Hours|Analysis was based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
654797|NCT01959945|Secondary|Seroprotection to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine|Seroprotection is defined as: A titer ≥ 40 (l/dil) at pre vaccination and at Day 28 after the final vaccination.|Day 28 after final vaccination|The evaluable immunogenicity population includes randomized subjects who received the assigned number of doses of study vaccine and have HAI titers available from blood draws taken at baseline and ~28 days following completion of immunization (~Day 56 for 2-dose subjects), which accounts for the discrepancy in Participants Analyzed.||percentage of participants||95% Confidence Interval|Number
654798|NCT01959945|Secondary|Seroconversion to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine|Seroconversion is defined as: Either a pre vaccination titer < 10 (1/dil) and a post vaccination titer ≥ 40 (1/dil), or a pre vaccination titer ≥ 10 (1/dil) and a ≥ 4 fold increase in post vaccination titer at Day 28 after the final vaccination.|Day 28 after final vaccination|The evaluable immunogenicity population includes randomized subjects who received the assigned number of doses of study vaccine and have HAI titers available from blood draws taken at baseline and ~28 days following completion of immunization (~Day 56 for 2-dose subjects), which accounts for the discrepancy in Participants Analyzed.||percentage of participants||95% Confidence Interval|Number
654799|NCT01959945|Secondary|Geometric Mean Titers of Antibodies to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine|Immunogenicity will be evaluated prior to vaccination and at 28 days after vaccination using the hemagglutination inhibition (HAI) technique. For each influenza vaccine strain, pre and post vaccination geometric mean titers (GMTs) and seroprotection and seroconversion will be calculated.|Day 0 and Day 28 after final vaccination (Cohort B includes 1-Dose subjects at Day 28 and 2-Dose subjects at Day 56)|The evaluable immunogenicity population includes randomized subjects who received the assigned number of doses of study vaccine and have HAI titers available from blood draws taken at baseline and ~28 days following completion of immunization (~Day 56 for 2-dose subjects), which accounts for the discrepancy in Participants Analyzed.||titer||95% Confidence Interval|Geometric Mean
654800|NCT01959945|Primary|Number of Participants Reporting Solicited Injection Site and Systemic Events and Unsolicited Adverse Events Following Vaccination With Quadrivalent Vaccine.|Solicited injection site reactions: Pain, Bruising, Redness, and Swelling; Solicited systemic reactions: Headache, Chills, Fever, Fatigue, Muscle Pain, Joint Pain and Nausea.|Day 0 up to Day 28 post vaccination|||participants|||Number
654801|NCT01959932|Primary|Levels of Carboxyhemoglobin (COHb)|"% COHb blood measurements performed in the evening of Day 5, expressed as % of saturation of hemoglobin.
Geometric Least Squares means are provided as descriptive statistics."|5 days|"The analysis was performed on the full analysis set (FAS) population.
The FAS consisted of all the randomized subjects who had at least 1 post randomization product use experience (if randomized to THS 2.2 or CC) and had at least 1 valid BoExp measurement (THS 2.2, CC, SA arms)."||% of saturation of hemoglobin||95% Confidence Interval|Least Squares Mean
654802|NCT01959932|Primary|Concentration of S-phenylmercapturic Acid (S-PMA)|"Concentrations measured at Day 5 in urine, adjusted for creatinine.
Geometric Least Squares means are provided as descriptive statistics."|5 days|"The analysis was performed on the full analysis set (FAS) population.
The FAS consisted of all the randomized subjects who had at least 1 post randomization product use experience (if randomized to THS 2.2 or CC) and had at least 1 valid BoExp measurement (THS 2.2, CC, SA arms)."||pg/mg creat||95% Confidence Interval|Least Squares Mean
654803|NCT01959932|Primary|Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA)|"Concentrations measured at Day 5 in urine, adjusted for creatinine.
Geometric Least Squares means are provided as descriptive statistics."|5 days|"The analysis was performed on the full analysis set (FAS) population.
The FAS consisted of all the randomized subjects who had at least 1 post randomization product use experience (if randomized to THS 2.2 or CC) and had at least 1 valid BoExp measurement (THS 2.2, CC, SA arms)."||ng/mg creat||95% Confidence Interval|Least Squares Mean
654804|NCT01959932|Primary|Concentration of Monohydroxybutenyl Mercapturic Acid (MHBMA)|"Concentrations measured at Day 5 in urine, adjusted for creatinine.
Geometric Least Squares (LS) means are provided as descriptive statistics."|5 days|"The analysis was performed on the full analysis set (FAS) population.
The FAS consisted of all the randomized subjects who had at least 1 post randomization product use experience (if randomized to THS 2.2 or CC) and had at least 1 valid biomarker of exposure (BoExp) measurement (THS 2.2, CC, SA arms)."||pg/mg creat||95% Confidence Interval|Least Squares Mean
654805|NCT01959880|Primary|6-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Explantation With or Without Replacement|Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest.|6 years|All enrolled subjects are included.||percentage of subjects||95% Confidence Interval|Number
655310|NCT01952665|Primary|Comfortable Wearing Time|Participant rating of lens Comfortable Wearing Time for both study pairs. Collected at 4 weeks wear. (The hours of average comfortable wearing time)|4 weeks|||hours||Standard Deviation|Mean
654806|NCT01959880|Primary|6-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Infection|Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest.|6 years|All enrolled subjects are included.||percentage of subjects||95% Confidence Interval|Number
654807|NCT01959880|Primary|6-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Baker III, IV Capsular Contracture|"Baker III was identified as firm with visible distortion and Baker IV was identified as obvious spherical distortion. Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest."|6 years|All enrolled subjects are included.||percentage of subjects||95% Confidence Interval|Number
654808|NCT01959880|Primary|6-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Any Reoperation|Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest.|6 years|All enrolled subjects are included.||percentage of subjects||95% Confidence Interval|Number
654809|NCT01959685|Primary|Cmax of a Single Dose of 250 mg Androxal||24 hours|Safety population||ng/dL||Standard Deviation|Mean
654810|NCT01959685|Primary|Pharmacokinetics|Cmax of a single dose 125 mg of Androxal|24 hrs|Safety population||ng/dL||Standard Deviation|Mean
654811|NCT01959607|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero (Pre-product Use) to Last Time Point [AUC(0-last)] Following Single Use of THS 2.2, CC and NRT|"T0 = start of single product use.
Derived from multiple blood sampling on Day 1 and Day 3 (1 blood sampling pre-product use and multiple blood sampling over 24 hours post-product use).
Geometric Least Squares means are provided."|Blood taken 15 minutes prior to T0, 2, 4, 6, 8, 10, 15, 30, 45 minutes, 1, 2, 4, 6, 9, 12, and 24 hours after T0|PK populations consisted of all the randomized subjects who completed at least 1 of the single use days (Days 1 or 3), and for whom at least 1 PK parameter could be derived. Subjects with major protocol deviations that impacted the evaluability of the results were excluded from the PK populations.||ng*h/mL||95% Confidence Interval|Least Squares Mean
654812|NCT01959607|Primary|Maximum Concentration (Cmax) of Nicotine Following Single Use of THS 2.2, CC and NRT|"T0 = start of single product use.
Derived from multiple blood sampling on Day 1 and Day 3 (1 blood sampling pre-product use and multiple blood sampling over 24 hours post-product use).
Geometric Least Squares means are provided."|Blood taken 15 minutes prior to T0, 2, 4, 6, 8, 10, 15, 30, 45 minutes, 1, 2, 4, 6, 9, 12, and 24 hours after T0|PK populations consisted of all the randomized subjects who completed at least 1 of the single use days (Days 1 or 3), and for whom at least 1 PK parameter could be derived. Subjects with major protocol deviations that impacted the evaluability of the results were excluded from the PK populations.||ng/mL||95% Confidence Interval|Least Squares Mean
654813|NCT01959581|Primary|Change in Time Contacting Objects|Percent of the assessment time participants are able to contact objects across different locations. Change within each session with versus without the exoskeleton donned. Slope of change across time in the intervention phase relative to in the baseline phase.|7 months|infants born with significant brain injury and toddlers with a diagnosis of arthrogryposis multiplex congenita||percentage of time||Standard Deviation|Mean
654814|NCT01959516|Secondary|Comparison of Glycopyrronium QD Versus Tiotropium QD on Symptoms Outcome|"Comparison of symptoms outcome between glycopyrronium QD versus tiotropium QD will be conducted via the PROMorning COPD Symptoms questionnaire. This questionnaire will be completed by participants at waking-up, pre-inhalation of study treatment (at home), and they will complete Part 2 of PRO-Morning COPD Symptoms questionnaire at site, 3hours post-inhalation of study treatment. The PRO-Morning COPD Symptoms Questionnaire is a self-administered patient reported outcome (PRO) instrument developed by the sponsor to evaluate patients' experience of early morning symptoms of COPD. The questionnaire consists of two parts : predose and postdose.
Each part has 6 questions and for each question a scale of 0 to 10 can be reached. For the predose and postdose part of the questionnaire you will have then each a total score of 0-60 by adding the sub-scores for each question, higher scores represent worse severity of COPD morning symptoms"|day 1 (baseline) and week 4|The intention-to-treat (ITT) population consisted of all randomized patients who received at least one dose of the study treatment and had at least one post-dose value of FEV1||Scores on a scale||95% Confidence Interval|Least Squares Mean
654815|NCT01959516|Primary|Forced Expiratory Volume in 1 Second (FEV1) AUC0-4h After First Dose of Treatment.|Forced Expiratory Volume in 1 second (FEV1) Area Under the Curve (AUC) will measured via spirometry and calculated from 0 to 4 hours post-dose on day 1 of study treatment.|Day 1|The intention-to-treat (ITT) population consisted of all randomized patients who received at least one dose of the study treatment and had at least one post-dose value of FEV1||Liters*hours||95% Confidence Interval|Least Squares Mean
654816|NCT01959503|Secondary|Proportion of Subjects With Device-Related Serious Adverse Events Following Assigned Treatment Through 30 Days||30 days post procedure|One subject in Progel Vascular Sealant and one subject in Gelfoam Plus discontinue before 30days and do not have device-related SAE. They are considered as not evaluable and are not included in this analysis, thus makes the difference compared to population in baseline.||participants|||Number
654817|NCT01959503|Secondary|Incidence of Reoperations for Aortic Bleeding Complications Following Treatment.||30 days post procedure|||participants|||Number
654818|NCT01959503|Secondary|Time Between Cross Clamp Removal and Request of Surgical Wires for Sternal Closure.||Intra-procedurally|In the Vascular group two subjects were not evaluable as information was not collected for this endpoint, which changes the number from 106 to 104, compare to baseline characteristics.||minutes||Standard Deviation|Mean
654819|NCT01959503|Secondary|Proportion of Subjects Who Received Transfusion Within 24 Hours Following Surgery||24 hours post procedure|In the Gelfoam Plus group one subject was not evaluable as information was not collected for this endpoint, which change the number from 50 to 49, compare to baseline characteristics.||participants|||Number
654820|NCT01959503|Secondary|Chest Tube Drainage Volume Following Surgery.||24 hours post procedure|In the Gelfoam Plus group one subject was not evaluable as information was not collected for this endpoint, which change the number from 50 to 49, compare to baseline characteristics.||mL||Standard Deviation|Mean
654822|NCT01959503|Secondary|Proportion of Subjects Who Achieve Successful Hemostasis at All Treated Aortic Anastomotic Suture Lines Following Assigned Treatment.||5 minutes after application|In the Progel group one subject was not evaluable as information was not collected for this endpoint, which change the number from 106 to 105, compare to baseline characteristics.||percentage of participants|||Number
654823|NCT01959503|Primary|Time to Achieve Hemostasis at the Aortic Anastomotic Suture Line From the Time Surgical Clamps Are Released to Cessation of Leakage at the Treated Anastomotic Site With Either Progel or Gelfoam.||0 seconds to 600 seconds|In the Progel group one subject was not evaluable as information was not collected for the primary end-point changing the number from 106 to 105, compare to baseline characteristics.||seconds||Standard Deviation|Mean
654824|NCT01959412|Secondary|Change From Period Baseline in FVC (L) AUC (0-24h)|Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC will be assessed via spirometry. A positive change from baseline in FVC indicates improvement in lung function.|Day 1 (24 hours)|The Full Analysis Set (FAS) consisted of all patients in the RAN who received at least 1 dose of study drug. Following the intent-to-treat principle, data for patients in the FAS were analyzed according to the treatment they were randomized to in the assigned treatment sequence. The FAS was used in the analysis of all efficacy variables||Liters||Standard Error|Least Squares Mean
654825|NCT01959412|Secondary|Change From Period Baseline in Trough FEV1 (L)|Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. The trough in FEV1 is defined as the mean of two measurements at different time points.|Day 1 (24 hours)|The Full Analysis Set (FAS) consisted of all patients in the RAN who received at least 1 dose of study drug. Following the intent-to-treat principle, data for patients in the FAS were analyzed according to the treatment they were randomized to in the assigned treatment sequence. The FAS was used in the analysis of all efficacy variables||Liters||Standard Error|Least Squares Mean
654826|NCT01959412|Secondary|Change From Period Baseline in Peak FEV1 (L)|Spirometry will be conducted according to internationally accepted standards. Peak Forced Expiratory Volume in 1 second (FEV1) is the maximum FEV1 recorded between different time points.|Day 1 (24 hours)|The Full Analysis Set (FAS) consisted of all patients in the RAN who received at least 1 dose of study drug. Following the intent-to-treat principle, data for patients in the FAS were analyzed according to the treatment they were randomized to in the assigned treatment sequence. The FAS was used in the analysis of all efficacy variables||Liters||Standard Error|Least Squares Mean
654827|NCT01959412|Secondary|Change From Period Baseline in FEV1 (L) AUC(0-12h) and FEV1 (L) AUC(12- 24h)|Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEV1 will be measured pre-dose and over a 12 hours post-dose period.|Day 1 (12 hours)|The Full Analysis Set (FAS) consisted of all patients in the RAN who received at least 1 dose of study drug. Following the intent-to-treat principle, data for patients in the FAS were analyzed according to the treatment they were randomized to in the assigned treatment sequence. The FAS was used in the analysis of all efficacy variables||liters||Standard Error|Least Squares Mean
654828|NCT01959412|Primary|Change From Period Baseline in FEV1 (L) AUC(0-24h)|Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEV1 will be measured pre-dose and over a 24 hours post-dose period.|Day 1 (24 hours)|drug. Following the intent-to-treat principle, data for patients in the FAS were analyzed according to the treatment they were randomized to in the assigned treatment sequence. The FAS was used in the analysis of all efficacy variables||Liters||Standard Error|Least Squares Mean
654829|NCT01959035|Secondary|Patients Categorised As Sexually Dysfunctional Measured at Week 12 on the ASEX Scale|The Arizona Sexual Experience Scale (ASEX) is a five-item, patient-rated scale that evaluates a patient’s recent sexual experiences. The ASEX is used to identify individuals with sexual dysfunction. Patients were asked to assess their own experiences over the last week (for example, “How strong is your sex drive?”, “Are your orgasms satisfying?”) and respond on a six-point scale for each item. Possible total scores range from 5 to 30. Higher ASEX total scores indicate more sexual dysfunction (hypofunction). The presence of sexual dysfunction based on the ASEX scale was defined as an ASEX total score of ≥19, or a score of ≥5 on any item, or a score of ≥4 on any 3 items.|Week 12|This analysis is based on all patients who received at least one dose of IMP in Study 14724B (APTS). At Week 12, the analysis for the number of patients categorised as sexually dysfunctional was based on the 82 patients who had a measure for this outcome||participants|||Number
654830|NCT01959035|Secondary|Change From Baseline to Week 12 in ASEX Total Score|The Arizona Sexual Experience Scale (ASEX) is a five-item, patient-rated scale that evaluates a patient’s recent sexual experiences. The ASEX is used to identify individuals with sexual dysfunction. Patients were asked to assess their own experiences over the last week (for example, “How strong is your sex drive?”, “Are your orgasms satisfying?”) and respond on a six-point scale for each item. Possible total scores range from 5 to 30. Higher ASEX total scores indicate more sexual dysfunction (hypofunction).|Baseline and Week 12|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 12, the analysis for ASEX total score was based on the 82 patients who had a measure for this outcome||units on a scale||95% Confidence Interval|Least Squares Mean
654831|NCT01959035|Secondary|Change From Baseline to Week 12 in the WoRQ Total Score|The Readiness for Work Questionnaire (WoRQ) is a clinician-rated scale designed to measure a schizophrenic patient’s ability to work. The WoRQ consists of 8 items: the clinician had to rate 7 statements and answer 1 question. The statements were rated on a four-point scale, from 'strongly agree', 'agree', 'disagree' or 'strongly disagree' based on all material available (for example, personal notes, medical records, input from other health professionals, family members or caregivers); and in the final item, the clinician had to indicate if the patient was ready for work or not (by indicating either 'yes' or 'no'). Possible total scores range from 4 to 28. Lower WoRQ total scores indicate better functioning.|Baseline and Week 12|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 12, the analysis for WoRQ total score was based on the 82 patients who had a measure for this outcome||units on a scale||95% Confidence Interval|Least Squares Mean
678087|NCT01601977|Secondary|Total Sleep Time|Full polysomnography performed at baseline (usual device) and 6 weeks (trial device) to examine TST|baseline, 6 weeks|||minutes||Standard Deviation|Mean
654832|NCT01959035|Secondary|Change From Baseline to Week 12 in the TooL Total Score|Tolerability and Quality of Life (TooL) is a patient-rated scale developed to measure the impact of side-effects on the quality of life in patients treated with antipsychotic medication. The TooL consists of 8 domains: mood (worry-upset), function capabilities, fatigue-weakness, weight gain, stiffness-tremor, physical restlessness, sexual dysfunction, and dizziness-nausea. Each domain was rated on a four-point scale from 1 (no impact) to 4 (maximum impact). Total scores ranged from 8 (no impact) to 32 (maximum impact).|Baseline and Week 12|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 12, the analysis for TooL total score was based on the 82 patients who had a measure for this outcome||units on a scale||95% Confidence Interval|Least Squares Mean
654833|NCT01959035|Secondary|Change From Baseline to Week 12 in the 'Instrumental Role' QLS Domain Score|The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Instrumental Role domain score was calculated as the sum of 4 items (numbers 9 to 12) giving a range of 0 to 24, where the higher score indicated less unimpaired functioning.|Baseline and Week 12|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 12, the analysis for 'Instrumental Role' QLS domain score was based on the 81 patients who had a measure for this outcome||units on a scale||Standard Deviation|Mean
654834|NCT01959035|Secondary|Change From Baseline to Week 12 in the 'Interpersonal Relations' QLS Domain Score|The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Interpersonal Relations domain score was calculated as the sum of 8 items (numbers 1 to 8) giving a range of 0 to 48, where the higher score indicated less unimpaired functioning|Baseline and Week 12|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 12, the analysis for 'Interpersonal Relations' QLS domain score was based on the 82 patients who had a measure for this outcome||units on a scale||Standard Deviation|Mean
654835|NCT01959035|Secondary|Change From Baseline to Week 12 in the 'Intrapsychic Foundations' QLS Domain Score|The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Intrapsychic Foundations domain score was calculated as the sum of 7 items (numbers 13 to 17 and 20 and 21) giving a range of 0 to 42, where the higher score indicated less unimpaired functioning|Baseline and Week 12|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 12, the analysis for 'Intrapsychic Foundations' QLS domain score was based on the 82 patients who had a measure for this outcome||units on a scale||Standard Deviation|Mean
654836|NCT01959035|Secondary|Change From Baseline to Week 12 in the 'Common Objects and Activities' QLS Domain Score|The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Common Objects and Activities domain score was calculated as the sum of 2 items (numbers 18 and 19) giving a range of 0 to 12, where the higher score indicated less unimpaired functioning|Baseline and Week 12|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 12, the analysis for 'Common Objects and Activities' QLS domain score was based on the 82 patients who had a measure for this outcome||units on a scale||Standard Deviation|Mean
654837|NCT01959035|Secondary|Change From Baseline to Week 12 in QLS Total Score|The Quality of Life Scale (QLS) is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). Definitions were provided for 4 anchor points of the 7 points. Each item had a brief description of the judgement to be made and a set of suggested probes for the clinician. The total score was calculated as the sum of all 21 items giving a range of 0 to 126, where the higher score indicated normal or unimpaired functioning.|Baseline and Week 12|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 12, the analysis for QLS total score was based on the 82 patients who had a measure for this outcome||units on a scale||95% Confidence Interval|Least Squares Mean
654838|NCT01959035|Secondary|Change From Baseline to Week 12 in CGI-S Score|Clinical Global Impression - Severity of Illness (CGI-S) score provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients).|Baseline and Week 12|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 12, the analysis for CGI-S score was based on the 83 patients who had a measure for this outcome||units on a scale||95% Confidence Interval|Least Squares Mean
654856|NCT01958827|Secondary|Systolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit|Blood pressure was measured while the participant was sitting. n=the number of participants with available data at each time point.|Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|Safety Analysis Set||mm Hg||Standard Deviation|Mean
654839|NCT01959035|Secondary|Change From Baseline to Week 12 in SWN-S Total Score|The Subjective Well-Being under Neuroleptic Treatment - Short Version (SWN-S) is a patient-rated scale designed to measure subjective effects of neuroleptic drugs to psychopathology, quality of life, and compliance over the past 7 days. The 20 items (10 positive and 10 negative statements) are grouped in 5 subscales (mental functioning, self-control, physical functioning, emotional regulation and social integration). Each subscale contains 4 items. Each item was rated on a six-point Likert scale, from not at all to very much. A score was calculated for each subscale, and the total score ranged from 20 to 120, where the higher score indicated better well-being.|Baseline and Week 12|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 12, the analysis for SWN-S total score was based on the 82 patients who had a measure for this outcome||units on a scale||95% Confidence Interval|Least Squares Mean
654840|NCT01959035|Secondary|Patients Categorised As Sexually Dysfunctional Measured at Week 24 on the ASEX Scale|The Arizona Sexual Experience Scale (ASEX) is a five-item, patient-rated scale that evaluates a patient’s recent sexual experiences. The ASEX is used to identify individuals with sexual dysfunction. Patients were asked to assess their own experiences over the last week (for example, “How strong is your sex drive?”, “Are your orgasms satisfying?”) and respond on a six-point scale for each item. Possible total scores range from 5 to 30. Higher ASEX total scores indicate more sexual dysfunction (hypofunction). The presence of sexual dysfunction based on the ASEX scale was defined as an ASEX total score of ≥19, or a score of ≥5 on any item, or a score of ≥4 on any 3 items.|Week 24|This analysis is based on all patients who received at least one dose of IMP in Study 14724B (APTS). At Week 24, the analysis for the number of patients categorised as sexually dysfunctional was based on the 75 patients who had a measure for this outcome||participants|||Number
654841|NCT01959035|Secondary|Change From Baseline to Week 24 in ASEX Total Score|The Arizona Sexual Experience Scale (ASEX) is a five-item, patient-rated scale that evaluates a patient’s recent sexual experiences. The ASEX is used to identify individuals with sexual dysfunction. Patients were asked to assess their own experiences over the last week (for example, “How strong is your sex drive?”, “Are your orgasms satisfying?”) and respond on a six-point scale for each item. Possible total scores range from 5 to 30. Higher ASEX total scores indicate more sexual dysfunction (hypofunction).|Baseline and Week 24|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 24, the analysis for ASEX total score was based on the 75 patients who had a measure for this outcome||units on a scale||95% Confidence Interval|Least Squares Mean
654842|NCT01959035|Secondary|Change From Baseline to Week 24 in the WoRQ Total Score|The Readiness for Work Questionnaire (WoRQ) is a clinician-rated scale designed to measure a schizophrenic patient’s ability to work. The WoRQ consists of 8 items: the clinician had to rate 7 statements and answer 1 question. The statements were rated on a four-point scale, from 'strongly agree', 'agree', 'disagree' or 'strongly disagree' based on all material available (for example, personal notes, medical records, input from other health professionals, family members or caregivers); and in the final item, the clinician had to indicate if the patient was ready for work or not (by indicating either 'yes' or 'no'). Possible total scores range from 4 to 28. Lower WoRQ total scores indicate better functioning.|Baseline and Week 24|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 24, the analysis for WoRQ total score was based on the 77 patients who had a measure for this outcome||units on a scale||95% Confidence Interval|Least Squares Mean
654843|NCT01959035|Secondary|Change From Baseline to Week 24 in the TooL Total Score|Tolerability and Quality of Life (TooL) is a patient-rated scale developed to measure the impact of side-effects on the quality of life in patients treated with antipsychotic medication. The TooL consists of 8 domains: mood (worry-upset), function capabilities, fatigue-weakness, weight gain, stiffness-tremor, physical restlessness, sexual dysfunction, and dizziness-nausea. Each domain was rated on a four-point scale from 1 (no impact) to 4 (maximum impact). Total scores ranged from 8 (no impact) to 32 (maximum impact).|Baseline and Week 24|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 24, the analysis for TooL total score was based on the 75 patients who had a measure for this outcome||units on a scale||95% Confidence Interval|Least Squares Mean
654844|NCT01959035|Secondary|Change From Baseline to Week 24 in the 'Instrumental Role' QLS Domain Score|The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Instrumental Role domain score was calculated as the sum of 4 items (numbers 9 to 12) giving a range of 0 to 24, where the higher score indicated less unimpaired functioning.|Baseline and Week 24|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 24, the analysis for 'Instrumental Role' QLS domain score was based on the 78 patients who had a measure for this outcome||units on a scale||Standard Deviation|Mean
654845|NCT01959035|Secondary|Change From Baseline to Week 24 in the 'Interpersonal Relations' QLS Domain Score|The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Interpersonal Relations domain score was calculated as the sum of 8 items (numbers 1 to 8) giving a range of 0 to 48, where the higher score indicated less unimpaired functioning.|Baseline and Week 24|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 24, the analysis for 'Interpersonal Relations' QLS domain score was based on the 78 patients who had a measure for this outcome||units on a scale||Standard Deviation|Mean
654910|NCT01958606|Secondary|Change in Submaximal Aerobic Capacity (VO2 at Ventilatory Threshold)||Baseline and 4 weeks|ventilatory threshold was not identifiable for one participant||ml/kg/min||95% Confidence Interval|Least Squares Mean
654911|NCT01958606|Primary|Change in Peak Aerobic Capacity (VO2-peak)||Baseline and 4 weeks|on treatment analysis||ml/kg/min||95% Confidence Interval|Least Squares Mean
654846|NCT01959035|Secondary|Change From Baseline to Week 24 in the 'Intrapsychic Foundations' QLS Domain Score|The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Intrapsychic Foundations domain score was calculated as the sum of 7 items (numbers 13 to 17 and 20 and 21) giving a range of 0 to 42, where the higher score indicated less unimpaired functioning|Baseline and Week 24|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 24, the analysis for 'Intrapsychic Foundations' QLS domain score was based on the 78 patients who had a measure for this outcome||units on a scale||Standard Deviation|Mean
654847|NCT01959035|Secondary|Change From Baseline to Week 24 in the 'Common Objects and Activities' QLS Domain Score|The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Common Objects and Activities domain score was calculated as the sum of 2 items (numbers 18 and 19) giving a range of 0 to 12, where the higher score indicated less unimpaired functioning|Baseline and Week 24|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 24, the analysis for 'Common Objects and Activities' QLS domain score was based 78 patients who had a measure for this outcome||units on a scale||Standard Deviation|Mean
654848|NCT01959035|Secondary|Change From Baseline to Week 24 in QLS Total Score|The Quality of Life Scale (QLS) is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). Definitions were provided for 4 anchor points of the 7 points. Each item had a brief description of the judgement to be made and a set of suggested probes for the clinician. The total score was calculated as the sum of all 21 items giving a range of 0 to 126, where the higher score indicated normal or unimpaired functioning.|Baseline and Week 24|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 24, the analysis for QLS total score was based on the 78 patients who had a measure for this outcome||units on a scale||95% Confidence Interval|Least Squares Mean
654849|NCT01959035|Secondary|Change From Baseline to Week 24 in CGI-S Score|Clinical Global Impression - Severity of Illness (CGI-S) score provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients).|Baseline and Week 24|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 24, the analysis for CGI-S score was based on the 78 patients who had a measure for this outcome||units on a scale||95% Confidence Interval|Least Squares Mean
654850|NCT01959035|Secondary|Change From Baseline to Week 24 in SWN-S Total Score|The Subjective Well-Being under Neuroleptic Treatment - Short Version (SWN-S) is a patient-rated scale designed to measure subjective effects of neuroleptic drugs to psychopathology, quality of life, and compliance over the past 7 days. The 20 items (10 positive and 10 negative statements) are grouped in 5 subscales (mental functioning, self-control, physical functioning, emotional regulation and social integration). Each subscale contains 4 items. Each item was rated on a six-point Likert scale, from not at all to very much. A score was calculated for each subscale, and the total score ranged from 20 to 120, where the higher score indicated better well-being.|Baseline and Week 24|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 24, the analysis for SWN-S total score was based on the 75 patients who had a measure for this outcome||units on a scale||95% Confidence Interval|Least Squares Mean
654851|NCT01959035|Primary|Safety and Tolerability|Number of treatment emergent adverse events (TEAEs).|Up to 24 weeks and 4-week safety follow up|Safety data is based on all patients who received at least one dose of investigational medicinal product (IMP) in Study 14724B.||number of events|||Number
654852|NCT01958827|Secondary|Number of Participants With Adverse Events (AEs)|"An AE is any untoward medical occurrence in a participant which does not necessarily have a causal relationship with this treatment. A serious AE (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs or TESAE) are defined as any event that began or worsened in severity after the first dose of study drug. The investigator assessed the relationship of each event to the use of study drug as either Reasonable possibility or No reasonable possibility of being related to study drug.
For more details on adverse events please see the AE section below."|60 weeks|Safety Analysis Set||participants|||Number
654853|NCT01958827|Secondary|Body Temperature: Mean Change From Baseline (Week 0) to Each Visit|n=the number of participants with available data at each time point.|Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|Safety Analysis Set||degrees Celcius||Standard Deviation|Mean
654854|NCT01958827|Secondary|Heart Rate: Mean Change From Baseline (Week 0) to Each Visit|Heart rate was measured while the participant was sitting. n=the number of participants with available data at each time point.|Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|Safety Analysis Set||bpm||Standard Deviation|Mean
654855|NCT01958827|Secondary|Diastolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit|Blood pressure was measured while the participant was sitting. n=the number of participants with available data at each time point.|Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|Safety Analysis Set||mm Hg||Standard Deviation|Mean
654857|NCT01958827|Secondary|Number of Participants With Potentially Significant Clinical Chemistry Parameters|Blood was collected for analysis at designated study visits; chemistry results were provided by a central laboratory. The number of participants with an abnormal laboratory result (higher than upper limit of normal [ULN] or lower than lower limit of normal [LLN]) meeting Common Toxicity Criteria (CTC) of Grade 3 or higher is summarized. n=the number of participants with CTC Grade <3 at baseline and a post-baseline value for each parameter.|52 weeks|Safety Analysis Set||participants|||Number
654858|NCT01958827|Secondary|Number of Participants With Potentially Significant Hematology Parameters|Blood was collected for analysis at designated study visits; hematology results were provided by each site laboratory. The number of participants with an abnormal laboratory result (higher than upper limit of normal [ULN] or lower than lower limit of normal [LLN]) meeting Common Toxicity Criteria (CTC) of Grade 3 or higher is summarized. Increase is signified by ↑. n=the number of participants with CTC Grade <3 at baseline and a post-baseline value.|52 weeks|Safety Analysis Set: All enrolled participants who received at least one dose of study drug.||participants|||Number
654859|NCT01958827|Other Pre-specified|Change in Number of Subjects Positive for Anti-Adalimumab Antibodies (AAA) From Baseline to Week 52|Serum samples with adalimumab concentration below 2 μg/mL were selected for AAA analyses. Samples were considered AAA positive if the measured AAA concentration was above 20 ng/mL. A subject was considered to be AAA positive if the subject had at least one AAA positive sample observed within 30 days following the subject's last adalimumab dose.|Baseline (Week 0) to Week 52|FAS||participants|||Number
654860|NCT01958827|Other Pre-specified|Change in Mean Serum Adalimumab Concentration From Baseline (Week 0) to Week 52|Blood samples were drawn prior to drug administration. Adalimumab concentrations in serum were determined using a validated heterogeneous electrochemiluminescence (ECL)-immunoassay method. The assay captures adalimumab via biotinylated anti-idiotypic antibody, and detects it via sulfo-tagged TNF-alpha. n=the number of participants with available data at each time point.|Baseline (Week 0) to Week 52|All participants in the FAS with available data at both time points.||µg/mL||Standard Deviation|Mean
654861|NCT01958827|Secondary|C-reactive Protein (CRP): Mean Change From Baseline (Week 0) to Week 52|C-reactive protein (CRP) was measured from blood samples as a marker for inflammation. Higher levels are indicative of more inflammation. Normal concentration in healthy human serum is usually lower than 0.3 mg/dL, slightly increasing with age. Last Observation Carried Forward (LOCF) was used for missing data.|Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|FAS||mg/dL||Standard Deviation|Mean
654862|NCT01958827|Secondary|Percentage of Participants Who Achieved Clinical Response 100 (CR100; Crohn's Disease Activity Index [CDAI] Decrease of 100 From Week 0) Every 4 Weeks up to Week 52|CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score above 450 indicates severe disease. Non-responder imputation (NRI) for missing CDAI observations was used.|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|FAS||percentage of participants||95% Confidence Interval|Number
654863|NCT01958827|Secondary|Percentage of Participants Who Achieved Clinical Response 70 (CR70; Crohn's Disease Activity Index [CDAI] Decrease ≥ 70 From Week 0) Every 4 Weeks up to Week 52|CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score above 450 indicates severe disease. Non-responder imputation (NRI) for missing CDAI observations was used.|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|FAS||percentage of participants||95% Confidence Interval|Number
654864|NCT01958827|Secondary|Percentage of Participants Who Achieved Clinical Response 50 (CR50; Crohn's Disease Activity Index [CDAI] Decrease ≥ 50 From Week 0) Every 4 Weeks up to Week 52|CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score above 450 indicates severe disease. Non-responder imputation (NRI) for missing CDAI observations was used. Week 8 was the primary outcome measure.|Weeks 4, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|FAS||percentage of participants||95% Confidence Interval|Number
654865|NCT01958827|Secondary|Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Every 4 Weeks up to Week 52|CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score above 450 indicates severe disease. Non-responder imputation (NRI) for missing CDAI observations was used.|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|FAS||percentage of participants||95% Confidence Interval|Number
654866|NCT01958827|Primary|Percentage of Participants Who Achieved Clinical Response 50 (CR50; Crohn's Disease Activity Index [CDAI] Decrease ≥ 50 From Week 0) at Week 8|CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score above 450 indicates severe disease. Non-responder imputation (NRI) for missing CDAI observations was used.|Week 8|Full Analysis Set (FAS): All enrolled participants who received at least one dose of study drug and had at least one post-treatment efficacy assessment.||percentage of participants||95% Confidence Interval|Number
654867|NCT01958788|Secondary|Beck Depression Inventory, 2nd Edition (BDI-II)|The BDI-II is a self-report questionnaire assessing a variety of depressive symptoms, including low mood, anhedonia, and worthlessness. Scores range from 0 to 63, with greater scores indicating greater depressive symptoms. The BDI-II was used to evaluate change from baseline in self-reported depressive symptoms.|Pretreatment to posttreatment (12 weeks) and 6-month Follow-Up|||units on a scale||Standard Deviation|Mean
654868|NCT01958788|Secondary|Beck Anxiety Inventory (BAI)|The BAI is a self-report questionnaire assessing affective, cognitive, and somatic anxiety over the preceding week. Scores range from 0 to 63, with greater scores representing greater self-reported anxiety. The BAI was used to evaluate change from baseline in self-reported anxiety.|Pretreatment to posttreatment (12 weeks) and 6-month Follow-Up|||units on a scale||Standard Deviation|Mean
654869|NCT01958788|Secondary|GAD Safety Behaviours Questionnaire (GAD-SBQ)|The GAD-SBQ is a self-report questionnaire assessing the tendency to use safety behaviours to cope with anxiety, such as reassurance-seeking and overpreparation. Scores range from 18 to 90, with greater scores indicating greater use of safety behaviours. The GA-SBQ was used to evaluate change from baseline in self-reported safety behaviours.|Pretreatment to posttreatment (12 weeks) and 6-month Follow-Up|||units on a scale||Standard Deviation|Mean
654870|NCT01958788|Secondary|Penn State Worry Questionnaire (PSWQ)|The PSWQ is a self-report questionnaire assessing excessive and uncontrollable worry. Scores range from 16 to 80, with greater scores indicating greater worry. The PSWQ was used to evaluate change from baseline in self-reported worry.|Pretreatment to posttreatment (12 weeks) and 6-month Follow-Up|||units on a scale||Standard Deviation|Mean
654871|NCT01958788|Secondary|Intolerance of Uncertainty Scale (IUS)|The IUS is a self-report questionnaire assessing intolerance of uncertainty, or the tendency to view uncertainty and its consequences as negative. Scores range from 27 to 135, with higher scores representing greater intolerance of uncertainty. The IUS was used to assess change from baseline in self-reported intolerance of uncertainty.|Pretreatment to posttreatment (12 weeks) and 6-month Follow-Up|||units on a scale||Standard Deviation|Mean
654872|NCT01958788|Secondary|Worry and Anxiety Questionnaire (WAQ)|The WAQ is a questionnaire assessing self-reported symptoms of GAD. Scores range from 0 to 56, with higher scores indicating greater severity of self-rated GAD symptoms. The measure was used to assess change from baseline in self-reported GAD symptoms (WAQ).|Pretreatment to posttreatment (12 weeks) and 6-month Follow-Up|||units on a scale||Standard Deviation|Mean
654873|NCT01958788|Primary|Clinician's Severity Rating (CSR) Scale of Anxiety Disorders Interview Schedule for DSM-IV (ADIS-IV)|The CSR is a severity rating scale ranging from 0-8. Scores of 4 or greater represent clinically significant symptoms, whereas scores lower than 4 indicate subclinical symptoms. Lower scores represent improved outcome. This measure was used to evaluate change from baseline in the severity of GAD symptoms as assessed by the ADIS-IV, a semi-structured clinical interview for Axis I disorders.|Pretreatment to posttreatment (12 weeks) and 6-month Follow-Up|||units on a scale||Standard Deviation|Mean
654874|NCT01958671|Secondary|Change From Baseline in DBP at Week 26|The change from baseline is the Week 26 DBP minus the Week 0 DBP. Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. Data presented exclude data following the initiation of rescue therapy.|Baseline and Week 26|Analysis population consisted of all randomized participants who received at least 1 dose of study treatment and had a baseline DBP measurement or at least 1 post-randomization DBP measurement subsequent to at least 1 dose of study treatment.||mmHg||95% Confidence Interval|Least Squares Mean
654875|NCT01958671|Secondary|Baseline Sitting Diastolic Blood Pressure (DBP)|Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. Change from baseline in DBP at Week 26 data are presented in the following outcome measure.|Baseline|Analysis population consisted of all randomized participants who had a baseline DBP measurement.||mmHg||Standard Deviation|Mean
654876|NCT01958671|Secondary|Change From Baseline in SBP at Week 26|The change from baseline is the Week 26 SBP minus the Week 0 SBP. Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. Data presented exclude data following the initiation of rescue therapy.|Baseline and Week 26|Analysis population consisted of all randomized participants who received at least 1 dose of study treatment and had a baseline SBP measurement or at least 1 post-randomization SBP measurement subsequent to at least 1 dose of study treatment.||mmHg||95% Confidence Interval|Least Squares Mean
654877|NCT01958671|Secondary|Baseline Sitting Systolic Blood Pressure (SBP)|Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. Change from baseline in SBP at Week 26 data are presented in the following outcome measure.|Baseline|Analysis population consisted of all randomized participants who had a baseline SBP measurement.||mmHg||Standard Deviation|Mean
654878|NCT01958671|Secondary|Change From Baseline in 2-hr PPG at Week 26|The change from baseline is the Week 26 2-hr PPG minus the Week 0 2-hr PPG. Laboratory measurements were performed 120 minutes following the start of the administration of the meal for the MMTT. Data presented exclude data following the initiation of rescue therapy.|Baseline and Week 26|Analysis population consisted of all randomized participants who received at least 1 dose of study treatment and had a baseline 2-hr PPG measurement or at least 1 post-randomization 2-hr PPG measurement subsequent to at least 1 dose of study treatment.||mg/dL||95% Confidence Interval|Least Squares Mean
654879|NCT01958671|Secondary|Baseline 2-hour Post-prandial Glucose (2-hr PPG) Level|Laboratory measurements were performed 120 minutes following the start of the administration of the meal for the Mixed Meal Tolerance Test (MMTT). Change from baseline in 2-hr PPG level at Week 26 data are presented in the following outcome measure.|Baseline|Analysis population consisted of all randomized participants who had a baseline 2-hr PPG measurement.||mg/dL||Standard Deviation|Mean
654880|NCT01958671|Secondary|Percentage of Participants With A1C <7% (<53 mmol/Mol) at Week 26|A1C is measured as percent. Laboratory measurements were performed after an overnight fast ≥10 hours in duration. Data presented exclude data following the initiation of rescue therapy.|Week 26|Analysis population consisted of all randomized participants who received at least 1 dose of study treatment and had a baseline A1C measurement or at least 1 post-randomization A1C measurement subsequent to at least 1 dose of study treatment.||Percentage of participants|||Number
654881|NCT01958671|Secondary|Change From Baseline in Body Weight at Week 26|The change from baseline is the Week 26 body weight minus the Week 0 body weight. Data presented exclude data following the initiation of rescue therapy.|Baseline and Week 26|Analysis population consisted of all randomized participants who received at least 1 dose of study treatment and had a baseline body weight measurement or at least 1 post-randomization body weight measurement subsequent to at least 1 dose of study treatment.||Kilograms||95% Confidence Interval|Least Squares Mean
654882|NCT01958671|Secondary|Change From Baseline in FPG at Week 26|The change from baseline is the Week 26 FPG minus the Week 0 FPG. Laboratory measurements were performed after an overnight fast ≥10 hours in duration. Data presented exclude data following the initiation of glycemic rescue therapy.|Baseline and Week 26|Analysis population consisted of all randomized participants who received at least 1 dose of study treatment and had a baseline FPG measurement or at least 1 post-randomization FPG measurement subsequent to at least 1 dose of study treatment.||mg/dL||95% Confidence Interval|Least Squares Mean
654883|NCT01958671|Primary|Percentage of Participants Discontinuing Study Treatment Due to an AE|An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Data presented include data following the initiation of rescue therapy.|Up to 52 weeks|Analysis population consisted of all randomized participants who received at least 1 dose of study treatment. Participants were classified according to randomized treatment.||Percentage of participants|||Number
654912|NCT01958346|Secondary|Sore Throat Grade on First Postoperative Day|Patients will be asked to rate their sore throat qualitatively as none, mild, moderate, or severe|Postoperative day one|||participants|||Number
654884|NCT01958671|Primary|Percentage of Participants Experiencing An Adverse Event (AE)|An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Data presented include data following the initiation of rescue therapy.|Up to 54 weeks (including 2 weeks following last dose)|Analysis population consisted of all randomized participants who received at least 1 dose of study treatment. Participants were classified according to randomized treatment.||Percentage of participants|||Number
654885|NCT01958671|Primary|Change From Baseline In A1C at Week 26|A1C is measured as percent. The change from baseline is the Week 26 A1C percent minus the Week 0 A1C percent. Laboratory measurements were performed after an overnight fast ≥10 hours in duration. Data presented exclude data following the initiation of rescue therapy.|Baseline and Week 26|Analysis population consisted of all randomized participants who received at least 1 dose of study treatment and had a baseline A1C measurement or at least 1 post-randomization A1C measurement subsequent to at least 1 dose of study treatment.||Percent||95% Confidence Interval|Least Squares Mean
654886|NCT01958645|Secondary|Change From Baseline D-dimer Concentration||predose and 1-8 hours|||mg/L||Standard Deviation|Mean
654887|NCT01958645|Secondary|Change From Baseline Factor II Concentrations by Clot Assay||Predose and 1-8 hours|||% (concentration)||Standard Deviation|Mean
654888|NCT01958645|Secondary|Change From Baseline Factor II Concentrations by ECL Assay||Predose and 1-8 hours|||umol/L||Standard Deviation|Mean
654889|NCT01958645|Secondary|Change From Baseline Endogenous Thrombin Potential (ETP)|For the baseline variables and adverse events the two placebo arms (placebo dose 1 and placebo dose 2) are recorded as one. For the secondary outcome measures the two placebo arms are recorded separately.|Predose and Days 1-5|||nM*min||Standard Deviation|Mean
654890|NCT01958645|Primary|Description of the Safety Profile in Terms of Adverse Events (AE),Vital Signs, ECG, Lab Variables, Immunogenicity and Physical Examination||From screening and up to the lab follow-up visit (Day 29)|||Participants|||Number
654891|NCT01958619|Secondary|Piperaquine AUC0-∞|Piperaquine Area under plasma concentration time curve from time zero extrapolated to infinity.|Days 1 pre-dose and post-dose at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours (Day 2), and, 48 (Day 3), 72 (Day 4), 96 (Day 5) and 168 (Day 8) hours post-dose. Sampling will also be done on Day 11, 15, 29 and 43.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
654892|NCT01958619|Secondary|Piperaquine Cmax|Piperaquine Observed maximum drug plasma concentration|Days 1 pre-dose and post-dose at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours (Day 2), and, 48 (Day 3), 72 (Day 4), 96 (Day 5) and 168 (Day 8) hours post-dose. Sampling will also be done on Day 11, 15, 29 and 43.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
654893|NCT01958619|Primary|OZ439 AUC0-∞|OZ439 Area under plasma concentration time curve from time zero extrapolated to infinity.|Days 1 pre-dose and post-dose at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours (Day 2), and, 48 (Day 3), 72 (Day 4), 96 (Day 5) and 168 (Day 8) hours post-dose. Sampling will also be done on Day 11, 15, 29 and 43.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
654894|NCT01958619|Primary|OZ439 Cmax|OZ439 observed maximum drug plasma concentration|Days 1 pre-dose and post-dose at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours (Day 2), and, 48 (Day 3), 72 (Day 4), 96 (Day 5) and 168 (Day 8) hours post-dose. Sampling will also be done on Day 11, 15, 29 and 43.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
654895|NCT01958606|Other Pre-specified|Change in Stroke Impact Scale|Cognition Domain Score of Stroke Impact Scale. Scores range from 0 to 100 (higher is better) and represent a sum of scores from multiple questions related to cognition.|Baseline and 4 weeks|||units on a scale from 0-100||Standard Deviation|Mean
654896|NCT01958606|Other Pre-specified|Change in Daily Physical Activity (Activity Monitor)||Baseline and 4 weeks|measure not used|||||
654897|NCT01958606|Other Pre-specified|Change in Transcranial Magnetic Stimulation (TMS) Responses Associated With Training Session 12|Primary variable is motor threshold (MT). Secondary variables include: motor evoked potential amplitude/latency and intracortical inhibition|Before and after training session 12|measure not used|||||
654898|NCT01958606|Other Pre-specified|Change in Transcranial Magnetic Stimulation (TMS) Responses Associated With Training Session 2|Primary variable is motor threshold (MT). Secondary variables include: motor evoked potential amplitude/latency and intracortical inhibition|Before and after training session 2|measure not used|||||
654899|NCT01958606|Other Pre-specified|Change in Transcranial Magnetic Stimulation (TMS) Responses From Baseline to 4 Weeks|Primary variable is motor threshold (MT). Secondary variables include: motor evoked potential amplitude/latency, corticomotor map size and volume and intracortical inhibition|Baseline and 4 weeks|measure not used|||||
654900|NCT01958606|Other Pre-specified|Change in Gait Kinematics/Kinetics During Session 1|3D motion capture and force plates|During session 1|measure not used|||||
654901|NCT01958606|Other Pre-specified|Change in Gait Kinematics/Kinetics From Baseline to Post Session 1|3D motion capture and force plates|Baseline and after session 1|measure not used|||||
654902|NCT01958606|Other Pre-specified|Change in Gait Kinematics/Kinetics From Baseline to 4 Weeks|3D motion capture and force plates|Baseline and 4 weeks|Measure not used|||||
654903|NCT01958606|Other Pre-specified|Change in Montreal Cognitive Assessment||Baseline and 4 weeks|Measure not used|||||
654904|NCT01958606|Other Pre-specified|Change in Self-Efficacy and Outcome Expectations for Exercise Scale||Baseline and 4 weeks|Outcome measure not used|||||
654905|NCT01958606|Secondary|Change in Fractional Utilization|Metabolic cost of gait as a percentage of aerobic capacity|Baseline and 4 weeks|Subjects with available data||percentage of aerobic capacity||95% Confidence Interval|Mean
654906|NCT01958606|Secondary|Change in Fastest Treadmill Speed (Steep Ramp Test)|fastest safe treadmill walking speed|Baseline and 4 weeks|||meters per second||95% Confidence Interval|Mean
654907|NCT01958606|Secondary|Change in Gait Economy (Mean Oxygen Uptake at Comfortable Walking Speed)|mean oxygen uptake at comfortable walking speed reported in units mLO2 per kilogram body weight per meter|Baseline and 4 weeks|Subjects with available data||mLO2/kg/m||95% Confidence Interval|Mean
654908|NCT01958606|Secondary|Change in 6-Minute Walk Test|distance walked in 6 minutes|Baseline and 4 weeks|||meters||95% Confidence Interval|Mean
654909|NCT01958606|Secondary|Change in Gait Velocity (10 Meter Walk Test)||Baseline and 4 weeks|||m/s||95% Confidence Interval|Least Squares Mean
654914|NCT01958164|Secondary|Percentage of Participants Who Achieved Restored CVAD Function After 1 Dose and 2 Doses, in Patients From the Actilyse Treatment Group.|This endpoint was defined as the number of doses required to achieve restored CVAD function in patients from the actilyse treatment group but was analysed as the percentage of participants who achieved restored CVAD function after 1 dose and 2 doses, in patients from the actilyse treatment group.|0 minutes and 240 minutes|All patients in the FAS who were randomised to the Actilyse treatment group||percentage of participants|||Number
654915|NCT01958164|Secondary|Restored CVAD Function 120 Minutes After Administration of the Second Dose of Study Medication Actilyse|Percentage of patients with restored CVAD function 120 minutes after administration of the second dose of study medication Actilyse (240 minutes after time 0)|240 minutes after first drug administration|All patients in the FAS who did not have restored CVAD function 120 minutes after first drug administration||percentage of participants||95% Confidence Interval|Number
654916|NCT01958164|Secondary|Restored CVAD Function 30 Minutes After Administration of the Second Dose of Study Medication Actilyse|Percentage of patients with restored CVAD function 30 minutes after administration of the second dose of study medication Actilyse (150 minutes after time 0)|150 minutes after first drug administration|All patients in the FAS who did not have restored CVAD function 120 minutes after first drug administration||percentage of participants||95% Confidence Interval|Number
654917|NCT01958164|Secondary|Restored CVAD Function 30 Minutes After Administration of Study Medication at Time 0|Percentage of patients with restored CVAD function 30 minutes after administration of study medication at time 0 (i.e. Actilyse® or saline solution)|30 minutes after first drug administration|Full analysis set (FAS) which included all randomised patients who received at least one dose of study medication.||percentage of participants||95% Confidence Interval|Number
654918|NCT01958164|Primary|Proportion of Patients With Restored CVAD Function at 120 Min After Administration of the First Dose of Study Medication|Proportion (percentage) of patients with restored central venous access device (CVAD) function at 120 min after administration of the first dose of study medication (i.e. Actilyse® or saline solution).|120 minutes after first drug administration|Full analysis set (FAS) which included all randomised patients who received at least one dose of study medication.||percentage of participants||95% Confidence Interval|Number
654919|NCT01958060|Secondary|AUC0-tz|Area under the concentration-time curve of the analyte in the plasma over the time interval from 0 to the last measurable time point of the dose (AUC0-tz ).|2h before study drug administration and 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 168h, 336h, 504h, 672h, 840h and 1008h after drug administration on day 1.|Pharmacokinetic set (PKS)||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
654920|NCT01958060|Secondary|AUC0-inf|"Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf).
AUC0-inf could be assessed only in 50 mg iv dose group as terminal phase was below lower limit of quantification (BLQ) for other dose groups. Therefore dose proportionality for AUC0-inf could not be performed in this trial."|2h before study drug administration and 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 168h, 336h, 504h, 672h, 840h and 1008h after drug administration on day 1.|Pharmacokinetic set (PKS):||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
654921|NCT01958060|Secondary|Cmax|Maximum measured concentration of BI 1034020 in plasma (Cmax).|2h before study drug administration and 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 168h, 336h, 504h, 672h, 840h and 1008h after drug administration on day 1.|Pharmacokinetic Set (PKS): This subject set included all subjects in the treated set who provide at least 1 observation for at least 1 secondary Pharmacokinetic (PK) endpoint without important protocol violations relevant to the evaluation of PK.||μg/mL||Geometric Coefficient of Variation|Geometric Mean
654922|NCT01958060|Primary|Percentage of Subjects With Drug Related Adverse Events|Percentage of subjects with investigator defined drug-related adverse events|from the first drug administration to end of trial, up to 50 days|Treated Set (TS)||percentage of participants|||Number
654923|NCT01958021|Secondary|QTc Interval|Time between the start of the Q wave and the end of the T wave corrected for heart rate|Baseline, cycle 1 day 15, cycle 2 day 1, cycle 3 day 1, cycle 4 day 1, cycle 5 day 1, cycle 6 day 1, cycle 7 day 1, cycle 8 day 1, cycle 9 day 1||||||
654924|NCT01958021|Secondary|Time to Definitive 10% Deterioration in the Global Health Status/Quality of Life (QOL) Scale Score of the EORTC QLQ-C30|The time to definitive 10% deterioration is defined as the time from the date of randomization to the date of event, which is defined as at least 10% relative to baseline worsening of the corresponding scale score (without further improvement above the threshold) or death due to any cause.|Up to approximately 20 months||||||
654925|NCT01958021|Secondary|Safety and Tolerability of LEE011|Safety will be determined by type, frequency and severity of adverse events per CTCAE version 4.03 and type, frequency and severity of laboratory toxicities per CTCAE version 4.03.|Up to approximately 21 months||||||
654926|NCT01958021|Secondary|Time to Definitive Deterioration of ECOG Performance Status in One Category of the Score|Time to definitive deterioration of ECOG performance status in one category of score is defined as the time from the date of randomization to the date of event, which is defined as at least one score lower than the baseline.|Up to approximately 20.5 months||||||
654927|NCT01958021|Secondary|Clinical Benefit Rate (CBR)|Clinical Benefit Rate (CBR) is defined as the proportion of patients with a best overall response of complete response (CR) or partial response (PR) or stable disease (SD) lasting more than 24 weeks as defined in RECIST 1.1.|Up to approximately 20 months||||||
654928|NCT01958021|Secondary|Overall Survival (OS)|Time from date of randomization to the date of death from any cause.|Up to approximately 65 months||||||
654929|NCT01958021|Secondary|Overall Response Rate (ORR) as Per Investigator Assessment|Overall response rate (ORR) is defined as the proportion of patients with the best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1. CR = Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR = At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.|Up to approximately 20 months|The Full Analysis Set (FAS- population) consisted of all randomized patients.||percentage of participants||95% Confidence Interval|Number
655229|NCT01954160|Primary|Urine Sodium Excretion|Within-subject comparison of increase in urine sodium excretion following saline loading before RSD and 13 weeks following RSD.|13 Weeks following Renal Denervation|Study terminated early, data not collected, endpoints not measured|||||
654930|NCT01958021|Primary|Progression Free Survival (PFS) Per Investigator Assessment|PFS, defined as the time from the date of randomization to the date of the first documented progression or death due to any cause. PFS was assessed via a local radiology assessment according to RECIST 1.1|Up to approximately 20 months|The Full Analysis Set (FAS- population) consisted of all randomized patients.||months||95% Confidence Interval|Median
654931|NCT01958008|Secondary|R(A,AUC)|R(A,AUC) (accumulation ratio of the BI 113608 in plasma at steady state after multiple oral administration over a uniform dosing interval tau, expressed as ratio of AUC at steady state and after first dose)|Pre-dose and 0:15(hours:min),0:30,0:45,1:00,1:30,2:00,3:00,4:00,6:00,9:00,11:45,71:45,167:45,611:45,623:45,635:45,647:45,648:15,648:30,648:45,649:00,649:30,650:00,651:00,652:00,654:00,657:00,660:00,672:00,696:00,720:00 hours after drug administration|PKS||ratio||Geometric Coefficient of Variation|Geometric Mean
654932|NCT01958008|Secondary|R(A,Cmax)|R(A,Cmax) (accumulation ratio of the BI 113608 in plasma at steady state after multiple oral administration over a uniform dosing interval tau, expressed as ratio of Cmax at steady state and after first dose)|Pre-dose and 0:15(hours:min),0:30,0:45,1:00,1:30,2:00,3:00,4:00,6:00,9:00,11:45,71:45,167:45,611:45,623:45,635:45,647:45,648:15,648:30,648:45,649:00,649:30,650:00,651:00,652:00,654:00,657:00,660:00,672:00,696:00,720:00 hours after drug administration|PKS||ratio||Geometric Coefficient of Variation|Geometric Mean
654933|NCT01958008|Secondary|T1/2,ss|T1/2,ss (terminal half life of the BI 113608 in plasma at steady state)|Pre-dose and 0:15(hours:min),0:30,0:45,1:00,1:30,2:00,3:00,4:00,6:00,9:00,11:45,71:45,167:45,611:45,623:45,635:45,647:45,648:15,648:30,648:45,649:00,649:30,650:00,651:00,652:00,654:00,657:00,660:00,672:00,696:00,720:00 hours after drug administration|PKS||hours||Geometric Coefficient of Variation|Geometric Mean
654934|NCT01958008|Secondary|Tmax,ss|Tmax,ss (time from last dosing to maximum concentration of the BI 113608 in plasma at steady state)|Pre-dose and 0:15(hours:min),0:30,0:45,1:00,1:30,2:00,3:00,4:00,6:00,9:00,11:45,71:45,167:45,611:45,623:45,635:45,647:45,648:15,648:30,648:45,649:00,649:30,650:00,651:00,652:00,654:00,657:00,660:00,672:00,696:00,720:00 hours after drug administration|PKS||hours||Full Range|Median
654935|NCT01958008|Secondary|AUC Tau,ss|AUC tau,ss (area under the concentration-time curve of the BI 113608 in plasma at steady state over a uniform dosing interval tau)|Pre-dose and 0:15(hours:min),0:30,0:45,1:00,1:30,2:00,3:00,4:00,6:00,9:00,11:45,71:45,167:45,611:45,623:45,635:45,647:45,648:15,648:30,648:45,649:00,649:30,650:00,651:00,652:00,654:00,657:00,660:00,672:00,696:00,720:00 hours after drug administration|PKS||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
654936|NCT01958008|Secondary|Cmax,ss|Cmax,ss (maximum measured concentration of BI 113608 in plasma at steady state over a uniform dosing interval tau)|Pre-dose and 0:15(hours:min),0:30,0:45,1:00,1:30,2:00,3:00,4:00,6:00,9:00,11:45,71:45,167:45,611:45,623:45,635:45,647:45,648:15,648:30,648:45,649:00,649:30,650:00,651:00,652:00,654:00,657:00,660:00,672:00,696:00,720:00 hours after drug administration|Pharmacokinetic set (PKS): The patient set for the evaluation of PK endpoints included all evaluable patients in the treated set which provided at least 1 observation for at least 1 PK endpoint without important protocol violations relevant to the evaluation of PK.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
654937|NCT01958008|Primary|Number (%) of Patients With Drug-related Adverse Events (AEs)|Number (%) of patients with drug-related adverse events (AEs)|AE's occuring upto end of treatment + 3 days follow up (Up to 31 days)|Treated set (TS)||percentage of participants|||Number
654938|NCT01957930|Secondary|Microvascular Endothelial Function|Microvascular function is measured with a single point iontophoresis after stimulation with topically applied acetylcholine (ACh) [endothelial-dependent], sodium nitroprusside (SNP) [endothelial-independent], and capsaicin [C-nociceptive dependent] vasculature response.|2 months||11/2015||||
654939|NCT01957930|Primary|Ischemic Foot Ulcer|The study outcome is the first hospitalization for ischemic foot ulcer, defined by the ICD-10 discharge code|Until hospitalization for ischemic foot ulcer or until 31 December 2011|||participants|||Number
654940|NCT01957865|Secondary|HIV RNA Suppression|HIV RNA suppression (<100 copies/ml) in each study arm|After month 9|Note: Missing data equals lack of suppression. The participant found to be HIV negative was not included in the analysis.||number of participants|||Number
654941|NCT01957865|Primary|Antiretroviral Therapy (ART) Adherence Levels|ART adherence in each study arms. Adherence is measured by the Wisepill real-time adherence monitor and calculated as the number of monitor opening signals received divided by the number of monitor opening signals expected, capped at 100%.|real time (for 9 months)|The participant found to be HIV negative was not included in the analysis.||Percent adherence||Standard Deviation|Mean
654942|NCT01957761|Primary|Clostridium Difficile Infections Strain Type Based on Restriction Endonuclease Analysis|Stool samples taken from patients with Clostridium Difficile Infections infection at the time of diagnosis will be assessed by restriction endonuclease analysis to determine strain type. In order to study the relationship between strain type and outcome of their infection (e.g, treatment failure, recurrence, complication of illness), patients will be followed throughout their illness and for 8 weeks after developing their infection.|On day 1 of diagnosis of Clostridium difficile infection|||cases of BI/NAP1/027|||Number
654943|NCT01957657|Secondary|Cmax (Maximum Measured Concentration of Faldaprevir in Plasma)|Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.|Day 4|Boehringer Ingelheim decided to stop the further development of the interferon-free combination therapy for Hepatitis C and terminated the trial prematurely on 27 Dec 2013. Since the sample size achieved at trial termination was much smaller than the planned sample size the pharmacokinetic endpoints were not determined.|||||
654944|NCT01957657|Secondary|Cmax (Maximum Measured Concentration of Deleobuvir (BI 207127) Metabolite (CD 6168 Acylglucuronide) in Plasma)|Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.|Day 4|Boehringer Ingelheim decided to stop the further development of the interferon-free combination therapy for Hepatitis C and terminated the trial prematurely on 27 Dec 2013. Since the sample size achieved at trial termination was much smaller than the planned sample size the pharmacokinetic endpoints were not determined.|||||
654945|NCT01957657|Secondary|Cmax (Maximum Measured Concentration of Deleobuvir (BI 207127) Metabolite (BI 208333) in Plasma)|Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.|Day 4|Boehringer Ingelheim decided to stop the further development of the interferon-free combination therapy for Hepatitis C and terminated the trial prematurely on 27 Dec 2013. Since the sample size achieved at trial termination was much smaller than the planned sample size the pharmacokinetic endpoints were not determined.|||||
654946|NCT01957657|Secondary|Cmax (Maximum Measured Concentration of Deleobuvir (BI 207127) Metabolite (CD 6168) in Plasma)|Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.|Day 4|Boehringer Ingelheim decided to stop the further development of the interferon-free combination therapy for Hepatitis C and terminated the trial prematurely on 27 Dec 2013. Since the sample size achieved at trial termination was much smaller than the planned sample size the pharmacokinetic endpoints were not determined.|||||
654947|NCT01957657|Secondary|AUC 0-infinity (Area Under the Concentration-time Curve of Faldaprevir in Plasma Over the Time Interval From 0 Extrapolated to Infinity)|Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.|Day 4|Boehringer Ingelheim decided to stop the further development of the interferon-free combination therapy for Hepatitis C and terminated the trial prematurely on 27 Dec 2013. Since the sample size achieved at trial termination was much smaller than the planned sample size the pharmacokinetic endpoints were not determined.|||||
654948|NCT01957657|Secondary|AUC 0-infinity (Area Under the Concentration-time Curve of Deleobuvir (BI 207127) Metabolite (CD 6168 Acylglucuronide) in Plasma Over the Time Interval From 0 Extrapolated to Infinity)|Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.|Day 4|Boehringer Ingelheim decided to stop the further development of the interferon-free combination therapy for Hepatitis C and terminated the trial prematurely on 27 Dec 2013. Since the sample size achieved at trial termination was much smaller than the planned sample size the pharmacokinetic endpoints were not determined.|||||
654949|NCT01957657|Secondary|AUC 0-infinity (Area Under the Concentration-time Curve of Deleobuvir (BI 207127) Metabolite (BI 208333) in Plasma Over the Time Interval From 0 Extrapolated to Infinity)|Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.|Day 4|Boehringer Ingelheim decided to stop the further development of the interferon-free combination therapy for Hepatitis C and terminated the trial prematurely on 27 Dec 2013. Since the sample size achieved at trial termination was much smaller than the planned sample size the pharmacokinetic endpoints were not determined.|||||
654950|NCT01957657|Secondary|AUC 0-infinity (Area Under the Concentration-time Curve of Deleobuvir (BI 207127) Metabolite (CD 6168) in Plasma Over the Time Interval From 0 Extrapolated to Infinity)|Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.|Day 4|Boehringer Ingelheim decided to stop the further development of the interferon-free combination therapy for Hepatitis C and terminated the trial prematurely on 27 Dec 2013. Since the sample size achieved at trial termination was much smaller than the planned sample size the pharmacokinetic endpoints were not determined.|||||
654951|NCT01957657|Secondary|Number (%) of Subjects With Drug-related Adverse Events|Number (percentage) of subjects with drug-related adverse events|From the first drug administration until last drug administration, up to 10 days|Treated set (TS) included all enrolled subjects, who had taken at least one dose of trial medication.||percentage of participants|||Number
654952|NCT01957657|Primary|Cmax (Maximum Measured Concentration of Deleobuvir (BI 207127) in Plasma)|Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.|Day 4|Boehringer Ingelheim decided to stop the further development of the interferon-free combination therapy for Hepatitis C and terminated the trial prematurely on 27 Dec 2013. Since the sample size achieved at trial termination was much smaller than the planned sample size the pharmacokinetic endpoints were not determined|||||
654953|NCT01957657|Primary|AUC 0-infinity (Area Under the Concentration-time Curve of Deleobuvir (BI 207127) in Plasma Over the Time Interval From 0 Extrapolated to Infinity)|Blood sampling for Pharmacokinetic (PK) profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.|Day 4|Boehringer Ingelheim decided to stop the further development of the interferon-free combination therapy for Hepatitis C and terminated the trial prematurely on 27 Dec 2013. Since the sample size achieved at trial termination was much smaller than the planned sample size the pharmacokinetic endpoints were not determined.|||||
654954|NCT01957579|Secondary|Number of Participants With Tumour Response in MM Patients|"Tumour response is defined as complete response (CR) or partial response (PR) (Durie M et al 2006).
CR: Negative immunofixation on the serum and urine, and Disappearance of any soft tissue plasmacytomas and 5% or less plasma cells in bone marrow PR: ≥50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥90% or to <200mg per 24 h. If the serum and urine M-protein are unmeasurable, a ≥50% decrease in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria. If serum and urine M-protein are unmeasurable, and serum free light assay is also unmeasurable, ≥50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma cell percentage was ≥30%. In addition to the above listed criteria, if present at baseline, a ≥50% reduction in the size of soft tissue plasmacytomas is also required."|From the baseline to30 days after the last dose of study drug|All patients with MM who received at least 1 dose of MEDI-551 and completed at least 1 post-baseline disease assessment.||Participants|||Number
654955|NCT01957579|Secondary|Number of Participants With Tumour Response in CLL Patients|"Tumour response is defined as complete remission (CR) or partial remission (PR) (Hallek M et al 2008).
CR: all of the following criteria have to be met, and patients have to lack disease-related constitutional symptoms; Lymphadenopathy: None; Hepatomegaly: None; Splenomegaly: None; Blood lymphocytes: <4000/μL; Marrow: Normocellular, <30%lymphocytes, no B-lymphoid nodules, hypocellular marrow defines CR with incomplete marrow recovery; Platelet count: >100000/μL; Hemoglobin: >11.0 g/dL; Neutrophils: >1500/μL PR: at least 2 of the criteria of group A plus 1 of the criteria of group B have to be met.
Group A: Lymphadenopathy: Decrease ≥50%; Hepatomegaly: Decrease ≥50%; Splenomegaly: Decrease ≥50%; Blood lymphocytes: Decrease ≥50% from baseline; Marrow: 50% reduction in marrow infiltrate, or B-lymphoid nodules.
Group B: Platelet count: 100000/μL or increase ≥50% over baseline; Hemoglobin: >11.0 g/dL or increase ≥50% over baseline; Neutrophils: >1500/μL or >50% improvement over baseline."|From the baseline to 30 days after the last dose of study drug|All patients with CLL who received at least 1 dose of MEDI-551 and completed at least 1 post-baseline disease assessment.||Participants|||Number
654956|NCT01957579|Secondary|Number of Participants With Tumour Response in DLBCL Patients|"Tumour response is defined as complete remission (CR) or partial remission (PR) (Cheson BD et al 2007).
CR: Nodal Masses: (a) FDG-avid or PET positive prior to therapy; mass of any size permitted if PET negative; (b) Variably FDG-avid or PET negative; regression to normal size on CT; Spleen, Liver: Not palpable, nodules disappeared. Bone Marrow: Infiltrate cleared on repeat biopsy; if indeterminate by morphology, immunohistochemistry should be negative.
PR: Nodal Masses: ≥50% decrease in sum of the product of the diameters (SPD) of up to 6 largest dominant masses; no increase in size of other nodes; (a) FDG-avid or PET positive prior to therapy; ≥1 PET positive at previously involved site; (b) Variably FDG-avid or PET negative; regression on CT. Spleen, Liver: ≥50% decrease in SPD of nodules (for single nodule in greatest transverse diameter); no increase in size of liver or spleen. Bone Marrow: Irrelevant if positive prior to therapy; cell type should be specified."|From the baseline to 30 days after the last dose of study drug|All patients with DLBCL who received at least 1 dose of MEDI-551 and completed at least 1 post-baseline disease assessment.||Participants|||Number
654957|NCT01957579|Secondary|Number of Participants With Tumour Response in FL Patients|"Tumour response is defined as complete remission (CR) or partial remission (PR) (Cheson BD et al 2007).
CR: Nodal Masses: (a) FDG-avid or PET positive prior to therapy; mass of any size permitted if PET negative; (b) Variably FDG-avid or PET negative; regression to normal size on CT; Spleen, Liver: Not palpable, nodules disappeared. Bone Marrow: Infiltrate cleared on repeat biopsy; if indeterminate by morphology, immunohistochemistry should be negative.
PR: Nodal Masses: ≥50% decrease in sum of the product of the diameters (SPD) of up to 6 largest dominant masses; no increase in size of other nodes; (a) FDG-avid or PET positive prior to therapy; ≥1 PET positive at previously involved site; (b) Variably FDG-avid or PET negative; regression on CT. Spleen, Liver: ≥50% decrease in SPD of nodules (for single nodule in greatest transverse diameter); no increase in size of liver or spleen. Bone Marrow: Irrelevant if positive prior to therapy; cell type should be specified."|From the baseline to 30 days after the last dose of study drug|All patients with FL who received at least 1 dose of MEDI-551 and completed at least 1 post-baseline disease assessment.||Participants|||Number
654958|NCT01957579|Secondary|Anti-MEDI-551 Antibodies|Only 1 patient was tested positive for ADA at pre-dose of Cycle 1 Day 1. However, it was considered as false-positive because the titer value was close to the cut point, and this patient was tested negative for ADA at all subsequent cycles post-baseline.|From baseline to 30 days after the last dose of study drug|Patients who have at least one post-baseline sample for Anti-MEDI-551 antibodies.||Participants|||Number
654959|NCT01957579|Secondary|MEDI-551 Trough Concentration Levels at Day 168|Lower limit of quantification for MEDI-551 was 0.1 μg/mL.|Day 168|Patients who have trough concentration data at Day 168||μg/mL||Standard Deviation|Mean
654960|NCT01957579|Secondary|MEDI-551 Trough Concentration Levels at Day 140|Lower limit of quantification for MEDI-551 was 0.1 μg/mL.|Day 140|Patients who have trough concentration data at Day 140||μg/mL||Standard Deviation|Mean
654961|NCT01957579|Secondary|MEDI-551 Trough Concentration Levels at Day 112|Lower limit of quantification for MEDI-551 was 0.1 μg/mL.|Day 112|Patients who have trough concentration data at Day 112||μg/mL||Standard Deviation|Mean
654962|NCT01957579|Secondary|MEDI-551 Trough Concentration Levels at Day84|Lower limit of quantification for MEDI-551 was 0.1 μg/mL.|Day 84|Patients who have trough concentration data at Day 84||μg/mL||Standard Deviation|Mean
654963|NCT01957579|Secondary|MEDI-551 Trough Concentration Levels at Day 56|Lower limit of quantification for MEDI-551 was 0.1 μg/mL.|Day 56|Patients who have trough concentration data at Day 56||μg/mL||Standard Deviation|Mean
654964|NCT01957579|Secondary|MEDI-551 Trough Concentration Levels at Day 28|Lower limit of quantification for MEDI-551 was 0.1 μg/mL.|Day 28|Patients who have trough concentration data at Day 28||μg/mL||Standard Deviation|Mean
654965|NCT01957579|Secondary|MEDI-551 Trough Concentration Levels at Day 7|Lower limit of quantification for MEDI-551 was 0.1 μg/mL.|Day 7|Patients who have trough concentration data at Day 7||μg/mL||Standard Deviation|Mean
654966|NCT01957579|Secondary|MEDI-551 Trough Concentration Levels at Day 0 (Pre-dose)|Lower limit of quantification for MEDI-551 was 0.1 μg/mL.|Day 0 (pre-dose)|Patients who have trough concentration data at Day 0 (pre-dose)||μg/mL||Standard Deviation|Mean
655268|NCT01953081|Secondary|Gastric Emptying by Breath Test|Time to 1/2 gastric emptying by breath test|180 minutes|One subject in the TD-8954 group did not receive the full dose of TD-8954 and was excluded from the TD-8954 analysis.||minutes||Standard Deviation|Mean
654967|NCT01957579|Secondary|Maximum Tolerated Dose|A dose was considered non-tolerated and dose escalation stopped if ≥2 of up to 6 evaluable patients experienced a DLT at any dose level. MTD is the last dose level before the non-tolerated dose.|From baseline to 28 days after the first dose of study drug|All subjects in the dose escalation phase who have received MEDI-551 at Day 1 and Day 8 and completed the safety follow-up through the dose-limiting toxicity (DLT) evaluation period (28 days), or who experienced a DLT.||mg/kg|||Number
654968|NCT01957579|Secondary|Number of Participants With Dose Limiting Toxicities|A MEDI-551 treatment-related AE of any toxicity grade that lead to an inability to receive a full cycle (2 doses) of MEDI-551, or, any Grade 3 or higher toxicity that could not be reasonably ascribed to another cause, such as disease progression or accident.|From baseline to 28 days after the first dose of study drug|All subjects in the dose escalation phase who have received MEDI-551 at Day 1 and Day 8 and completed the safety follow-up through the dose-limiting toxicity (DLT) evaluation period (28 days), or who experienced a DLT.||Participants|||Number
654969|NCT01957579|Primary|Number of Participants With Adverse Events||From baseline to 30 days after the last dose of study drug|All patients who received at least 1 dose of MEDI-551.||Participants|||Number
654970|NCT01957553|Primary|Preference|The subjects were asked which product they preferred (the Test product or SenSura) at the end of the investigation. The preference result shows the percentage of subjects preferring either the Test product or SenSura.|21+1 days|The ITT population was constituted by all randomized subjects with valid informed consent who had applied at least one test product and had valid information for the primary endpoint preference, or valid information for at least one product with respect to one of the secondary endpoints., who included all subject who contributed with endpoint data||percentage of participants|||Number
654971|NCT01957488|Primary|Leakage|The fraction of baseplates with No leakage/seeping under the baseplate was measured. Leakage/seeping under the baseplate was assessed after each baseplate change.|14 +- 1 days|||percentage of baseplates|Participants||Number
654972|NCT01957475|Primary|Degree of Leakage|"The degree of leakage is measured using a 32-point scale developed by Coloplast A/S, where 0 represents No leakage (best possible outcome) and 32 points represents full-plate leakage (worst possible outcome).
The degree of leakage was measured at each baseplate change."|14 days|||units on a scale|Participants|Standard Deviation|Mean
654973|NCT01957462|Primary|Degree of Leakage|"The degree of leakage is measured using a 32-point scale developed by Coloplast A/S, where 0 represents No leakage (the best possible outcome) and 32 points represents full plate leakage (worst possible outcome).
The degree of leakage is measured at each baseplate change"|14 days|||units on a scale|Participants|Standard Deviation|Mean
654974|NCT01957410|Primary|Comparison of Ketamine Responders and Ketamine Non-responders in the Change From Baseline in Motor Evoked Potential (MEPs) Amplitudes at 4 Hours Postdose on Day 1|MEPs are generated when stimulation of the brain on the motor cortex (with Transcranial Magnetic Stimulation [TMS]) causes the spinal cord and peripheral muscles to produce neuroelectrical signals. MEPs are typically measured in the hand muscles. The Motor Evoked Response to Transcranial Magnetic Stimulation (TMS MEPs) was evaluated at baseline and regularly after study drug administration. Intracortical inhibition and facilitation was also evaluated using TMS. A figure-of-eight coil with external loop diameters of 9 cm was used to elicit motor responses in the contralateral first dorsal interosseus.|Baseline and Day 1 (4 hours postdose)|Efficacy analysis set included all participants who received a dose of ketamine and who had at least 1 postbaseline value of MEP.||mV||Standard Deviation|Mean
654975|NCT01957410|Primary|Comparison of Ketamine Responders and Ketamine Non-responders in the Change From Baseline in Somatosensory Evoked Potential (SEPs) Amplitudes at 4 Hours Postdose on Day 1|SEPs are the electrical signals generated by the nervous system in response to somatosensory stimuli - typically through electrical stimulation of the median nerve. SEPs are read on the skull with electroencephalography (EEG). SEPs was recorded using a 64-channel EEG system at baseline (predose) and regularly after study drug administration. The change from baseline was calculated as post-baseline value minus baseline value for each participant. Since the number of participants at baseline differ from the number of participants at post-baseline measure (that is [i.e.] not all baseline values are paired), the mean change is not equal to the difference between the means at the two time points.|Baseline and Day 1 (4 hours postdose)|Efficacy analysis set included all participants who received a dose of ketamine and who had at least 1 postbaseline value of SEP (P40).||millivolts (mV)||Standard Deviation|Mean
654976|NCT01957397|Primary|Degree of Leakage|The degree of leakage was measured with a 32 -point scale developed by Coloplast A/S, where 0 is the best possible outcome (no leakage) and 32 is the worst possible outcome (full leakage under the baseplate)|14 days|||units on a scale|Participants|Standard Deviation|Mean
654977|NCT01957384|Primary|Degree of Leakage|The degree of leakage was measured on a 24-point scale 0 (best possible outcome) to 24 (worst possible outcome) developed by Coloplast A/S|Up to 14 days per test product|||units on a scale|Participants|Standard Deviation|Mean
654978|NCT01957215|Secondary|Total Dose of Rescue Medication Use|Rescue medication use was monitored throughout a period of 14 days.|Baseline (Day 1) to Day 14|Efficacy analysis was conducted on ITT population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement||Dose||Full Range|Median
654979|NCT01957215|Secondary|Time to First Dose of Rescue Medication Use|Rescue medication use was monitored throughout a period of 14 days.|Baseline (Day 1) to Day 14|Efficacy analysis was conducted on ITT population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement||Days||95% Confidence Interval|Median
654980|NCT01957215|Secondary|Rate of Rescue Medication Use|Rescue medication use was monitored throughout a period of 14 days.|Baseline (Day 1) to Day 14|Efficacy analysis was conducted on ITT population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement||Number of participants|||Number
654981|NCT01957215|Secondary|Patients' Global Assessment to Treatment|Patients global assessment in response to treatment was measured at the end of the study on a scale of 0 to 4 where: 0- Poor; 1- Fair; 2- Good; 3- Very Good; 4- Excellent|Baseline (Day 1) to Day 14|Efficacy analysis was conducted on ITT population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement||Score on scale||Standard Error|Least Squares Mean
656064|NCT01940497|Secondary|Percentage of Participants Who Received Concomitant Medications||Screening (Day -28 to -1) up to 2.5 years (assessed up to cut off date 05 April 2016)|Safety population||percentage of participants|||Number
654982|NCT01957215|Secondary|Total Pain Relief (TOTPAR) on Movement|"TOTPAR was calculated as sum of products of pain relief (PR) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0 hrs (Day 1, baseline), 0.5 hrs, 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs, 60 hrs, 72 hrs, 84 hrs, 96 hrs, 108 hrs, 120 hrs, 132 hrs and 144 hrs. Higher score indicated greater pain relief.
TOTPARt = ∑PR x (time t – time t-1). PR score was assessed at each of the above time-points based on a 5-point categorical scale [0-no relief, 1-little relief, 2-meaningful relief, 3-a lot of relief, 4-complete relief]."|Baseline (Day 1) to Day 7|Efficacy analysis was conducted on ITT population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement||Score on scale||Standard Error|Mean
654983|NCT01957215|Secondary|Sum of Pain Intensity Difference and Pain Relief (SPRID) on Movement|"SPRID:Sum of Pain Intensity Difference (SPID) and Total Pain Relief (TOTPAR) at each post-dosing time-point.
SPRID score ranged from -5.8 (least pain relief) to 40.3 (highest pain relief). SPID and TOTPAR were calculated as weighted sums of Pain Intensity Differences (PID) and Pain Relief Scores (PRS) at each measurement time; 0 hr (Day 1, pre treatment), 0.5 hr, 1 hr, 2 hr, 4 hr, 8 hr, 12 hr, 24 hr, 36 hr, 48 hr, 60 hr, 72 hr, 84 hr, 96 hr, 108 hr, 120 hr, 132 hr and 144 hr, respectively.
PID was derived by subtracting the pain severity score at a given post-dosing time-point from the baseline [based on NRS which is a horizontal line with a scale from 0-10. where 0 represents “No” and 10 represents the “worst possible pain”]. NR scores were converted into PID scores by subtracting them from baseline pain scores.
PRS was assessed on 5-point categorical pain relief rating scale [0-no relief, 1-little relief, 2-some relief, 3-a lot of relief, 4-complete relief]"|Baseline (Day 1) to Day 7|Efficacy analysis was conducted on ITT population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement||Score on scale||Standard Error|Least Squares Mean
654984|NCT01957215|Secondary|Assessment of Sum of Pain Intensity Difference (SPID) on Movement|"SPID was calculated as sum of products of Pain Intensity Differences (PID) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0 hrs (Day 1, pre treatment), 0.5 hrs, 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs, 60 hrs, 72 hrs, 84 hrs, 96 hrs, 108 hrs, 120 hrs, 132 hrs and 144 hrs. Positive and higher scores indicate greater reduction in pain. SPIDt = ∑PID x (time t - time t-1).
Pain Intensity was assessed at baseline and at each time-point based on numerical rating scale (NRS) which is a horizontal line with a scale from 0-10, where 0 represents “No” and 10 represents the “worst possible pain”."|Baseline (Day 1) to Day 7|Efficacy analysis was conducted on ITT population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement||Score on scale||Standard Error|Least Squares Mean
654985|NCT01957215|Secondary|Time to Onset of Pain Relief|"Time to onset of pain relief was measured by the time to reach a pain relief score of 1 (“A little or perceptible pain relief”)."|Baseline (Day 1) to Day 3|Efficacy analysis was conducted on ITT population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement||Days||Full Range|Median
654986|NCT01957215|Secondary|Change From Baseline in NRS at Rest|Mean changes in pain intensity at each time point at rest twice daily (in the morning and afternoon) from treatment day 1 to day 7 between treatment groups at time points 0.5 hrs, 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs, 60 hrs, 72 hrs, 84 hrs, 96 hrs, 108 hrs, 120 hrs, 132 hrs and 144 hrs was measured using NRS. The NRS is a horizontal line with a scale from 0-10. After application of patch (indomethacin or reference patch), participants were asked to choose a number that relates to their pain intensity on the scale of 0 to 10, where 0 represents no pain and 10 represents the worst possible pain.|Baseline (Day 1) to Day 7|Efficacy analysis was conducted on ITT population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement||Score on scale||Standard Error|Least Squares Mean
654987|NCT01957215|Secondary|NRS for Pain on Movement Over Time|"NRS was assessed for pain on movement (walking 5 steps on flat surface) at 30, 60 minutes and 2, 4, 8 and 12 hrs after the first dose of treatment (indomethacin or placebo patch) and twice daily during the period from 12 hours to 24 hr, 36 hr, 48 hr, 60 hr, 72 hr, 84 hr, 96 hr, 108 hr, 120 hr, 132 hr and 144 hr between treatment groups.
The NRS is a horizontal line with a scale from 0-10. After application of patch (indomethacin or reference patch), patients were asked to choose a number that relates to their pain intensity on the scale of 0 to 10, where 0 represents no pain and 10 represents the worst possible pain."|30 mins to 144 hr post treatment|Efficacy analysis was conducted on ITT population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement||Score on scale||Standard Deviation|Mean
654988|NCT01957215|Secondary|Pain Relief Score (PRS) on Movement Over Time|"PRS was assessed for pain on movement (walking 5 steps on flat surface) at 30, 60 minutes and 2, 4, 8 and 12 hrs after the first dose of treatment (indomethacin or placebo patch) and twice daily during the period from 12 hours to 24 hr, 36 hr, 48 hr, 60 hr, 72 hr, 84 hr, 96 hr, 108 hr, 120 hr, 132 hr and 144 hr between treatment groups.
Participants were asked to choose a number on a scale of 0 to 4, where, 0- No pain relief; 1- A little or perceptible pain relief; 2- Meaningful pain relief; 3- A lot of relief; 4- Complete relief. The mean PRS scores were calculated on the basis of participant's response based on the above score."|30 minutes (mins) to 144 hours (hrs) post treatment|Efficacy analysis was conducted on ITT population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement.||Score on scale||Standard Deviation|Mean
654989|NCT01957215|Primary|Sum of Pain Intensity Difference (SPID)1-3 Days|"SPID was calculated as sum of products of Pain Intensity Differences (PID) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0 hrs (Day 1, pre treatment), 0.5 hrs, 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, 36 hrs and 48 hrs. Positive and higher scores indicate greater reduction in pain. SPIDt = ∑PID x (time t - time t-1).
Pain Intensity was assessed at baseline and at each time-point based on numerical rating scale (NRS) which is a horizontal line with a scale from 0-10, where 0 represents “No” and 10 represents the “worst possible pain”"|Baseline (Day 1) to Day 3|Efficacy analysis was conducted on the Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement||Score on scale||Standard Error|Least Squares Mean
655269|NCT01953081|Secondary|Cmax|Maximum plasma concentration|72 hours|One subject did not receive the full dose of TD-8954 and was excluded from PK analysis for the TD-8954 group; Metoclopramide concentrations were not measured in the Metoclopramide group.||pg/mL||Standard Deviation|Mean
654990|NCT01957202|Secondary|Weighted Mean of the Total Ocular Symptom Score (TOSS) (0-4) Hours (h) Post Start of Allergen Chamber Challenge on Day 8 of Each Treatment Period|The TOSS (score of 0-9) is defined as the sum of the symptom scores for the three individual components (red, itchy, and tearing eyes , each scored on 0-3 scale [0=none, 1=mild, 2=moderate, 3=severe], average of two eyes). TOSS was measured at the pre-allergen chamber challenge, and then every 15 minutes from 0 to 4 hours post start of the allergen chamber challenge. In the Environmental Exposure Chamber (EEC), aerosolized allergen was administered in a sealed chamber to evaluate the efficacy of antihistamines/other treatments. Weighted mean TOSS was calculated by dividing the value of the area under the response time curve over the 0-4 hours (calculated by trapezoidal rule) by the time interval of available data.|Day 8 of each treatment period (up to 80 days)|PD Population. Only those participants contributing data at the indicated time points were analyzed.||Scores on a scale||95% Confidence Interval|Least Squares Mean
654991|NCT01957202|Secondary|Weighted Mean of the Magnitude of Symptom Relief on Total Ocular Symptom Score (TOSS) (2-4) Hours (h) Post Start of Allergen Chamber Challenge on Day 1 of Each Treatment Period|Magnitude of symptom relief was assessed by calculating change from pre-dose weighted mean TOSS (2-4h) post start of the allergen chamber challenge at Day 1. The pre-dose value was the maximum of the three pre-dose measurements (1h 15 minutes (min), 1h 30 min and 1h 45 min post start of the allergen chamber challenge). The TOSS (score of 0-9) is defined as the sum of the symptom scores for the three individual components (red, itchy, and tearing eyes, each scored on 0-3 scale [0=none, 1=mild, 2=moderate, 3=severe], average of two eyes).|Day 1 of each treatment period (up to 80 days)|PD Population||Scores on a scale||95% Confidence Interval|Least Squares Mean
654992|NCT01957202|Secondary|Weighted Mean of the Magnitude of Symptom Relief on Total Nasal Symptom Score (TNSS) (2-4) Hours (h) Post Start of Allergen Chamber Challenge on Day 1 of Each Treatment Period|Magnitude of symptom relief was assessed by calculating change from pre-dose weighted mean TNSS (2-4h) post start of the allergen chamber challenge at Day 1. The pre-dose value was the maximum of the three pre-dose measurements (1h 15 minutes (min), 1h 30 min and 1h 45 min post start of the allergen chamber challenge). The TNSS (score of 0-12) is defined as the sum of the symptom scores for the four individual components (nasal congestion, rhinorrhea, nasal itch and sneezing, each scored on 0-3 scale [0=none, 1=mild, 2=moderate, 3=severe]).|Day 1 of each treatment period (up to 80 days)|PD Population||Scores on a scale||95% Confidence Interval|Least Squares Mean
654993|NCT01957202|Primary|Weighted Mean of the Total Nasal Symptom Score (TNSS) (0-4) Hours (h) Post Start of Allergen Chamber Challenge on Day 8 of Each Treatment Period|The TNSS (score of 0-12) is defined as the sum of the symptom scores for the four individual components (nasal congestion, rhinorrhea, nasal itch, and sneezing, each scored on 0-3 scale [0=none, 1=mild, 2=moderate, 3=severe]). TNSS was measured at the pre-allergen chamber challenge, and then every 15 minutes from 0 to 4 hours post start of the allergen chamber challenge. In the Environmental Exposure Chamber (EEC), aerosolized allergen was administered in a sealed chamber to evaluate the efficacy of antihistamines/other treatments. Weighted mean TNSS was calculated by dividing the value of the area under the response time curve over the 0-4 hours (calculated by trapezoidal rule) by the time interval of available data.|Day 8 of each treatment period (up to 80 days)|Pharmacodynamic (PD) Population: all participants in the All Subjects Population (defined as all participants who received at least one dose of investigational product) and who also provided data from at least one PD assessment. Only those participants contributing data at the indicated time points were analyzed.||Scores on a scale||95% Confidence Interval|Least Squares Mean
654994|NCT01957163|Secondary|Change From Baseline in Weighted Mean (WM), 0-6 Hour FEV1 Obtained Post-dose at Day 84|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The 0-6 hour weighted mean was derived by calculating the area under the FEV1/time curve over the nominal time points of 0 hour (trough value), 15 and 30 min, 1, 3 and 6 hours, using the trapezoidal rule, and then dividing by the actual time between dosing and the 6 hour assessment. Analysis was performed using MMRM with covariates of treatment, Baseline FEV1 (mean of the two assessments made 30 minutes and 5 minutes pre-dose on Day 1), smoking status, Day, and Day by Baseline and Day by treatment interactions. Baseline FEV1 is the mean of the two assessments made at 30 and 5 min pre-dose on Day 1. The change from baseline value is the difference between the on-treatment value and the baseline value.|Day 84|ITT Population. Number of participants presented represent those with data available at the time point being presented; however, all participants in the ITT population without missing covariate information and with at least one post baseline measurement are included in the analysis.||Liters||Standard Error|Least Squares Mean
654995|NCT01957163|Primary|Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) at Day 85|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Day 85 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Day 84. Analysis was performed using a mixed model repeated measures (MMRM) with covariates of treatment, Baseline FEV1, smoking status, Day, treatment, Day by baseline interaction and Day by treatment interaction, Day being nominal. Baseline FEV1 is the mean of the two assessments made at 30 and 5 minutes (min) pre-dose on Day 1. The change from baseline value is the difference between the on-treatment value and the baseline value.|Day 85|ITT Population: all pars. randomized to treatment who received ≥ 1 dose of randomized study medication in the Treatment Period. Number of pars. presented represent those with data available at given time point; however, all pars. in the ITT population without missing covariate information, with ≥ 1 post BL measurement are included in the analysis.||Liters||Standard Error|Least Squares Mean
654996|NCT01957137|Secondary|Adverse Events - no Stimulation|Summary of adverse device effects when subjects were under no stimulation is provided. Percentage of subjects experiencing any type of Adverse Device Effect under no stimulation is presented.|4 Weeks|28 subjects who received no stimulation were included in the analysis.||Percent of Subjects|||Number
654997|NCT01957137|Secondary|Global Response Assessment - no Stimulation|Summary of GRA under no stimulation setting is provided. The GRA assessed incontinence symptoms as compared to symptoms prior to subject’s entry into the study. Subjects were asked how much their incontinence changed since starting the study: markedly worse, moderately worse, mildly worse, same, slightly improved, moderately improved, or markedly improved. The responses to the symptom change were categorized into three levels for the analysis: worse (markedly worse, moderately worse, mildly worse), same (same), better (slightly improved, moderately improved, or markedly improved).|4 Weeks|28 subjects who received no stimulation were included in the analysis.||Percent of Subjects|||Number
654998|NCT01957137|Secondary|Number of Pads Used Per Day - no Stimulation|Number of pad use were collected through a diary on daily basis for approximately 4 weeks when subjects were under no stimulation. Only the last 7-day diaries were used for the analysis. The first 3 weeks were used as an adjustment period.|4 Weeks|28 subjects who received no stimulation were included in the analysis.||Pad use / day||Standard Deviation|Mean
654999|NCT01957137|Secondary|Degree of Urgency - no Stimulation|Each UUI episode was rated on following scales: 0=None, 1=Mild, 2=Moderate, 3=Severe, which were collected through a diary on daily basis for approximately 4 weeks when subjects were under no stimulation. The average degree of urgency per UUI episode was calculated from the last 7-day diaries were used for the analysis. The first 3 weeks were used as an adjustment period.|4 weeks|28 subjects who received no stimulation were included in the analysis.||units on a scale||Standard Deviation|Mean
655000|NCT01957137|Secondary|Number of UUI Episodes Per Day - no Stimulation|UUI episodes were collected through a diary on daily basis for approximately 4 weeks when subjects were under no stimulation. Only the last 7-day diaries were used for the analysis. The first 3 weeks were used as an adjustment period.|4 Weeks|28 subjects who received no stimulation were included in the analysis.||Number of UUI episodes/ Day||Standard Deviation|Mean
655001|NCT01957137|Secondary|Global Response Assessment (GRA) - Randomized Portion|"Summary statistics of GRA at different cycling settings are provided. The GRA assessed incontinence symptoms as compared to symptoms prior to subject’s entry into the study. Subjects were asked how much their incontinence changed since starting the study: markedly worse, moderately worse, mildly worse, same, slightly improved, moderately improved, or markedly improved. The responses to the symptom change were categorized into three levels for the analysis: worse (markedly worse, moderately worse, mildly worse), same (same), better (slightly improved, moderately improved, or markedly improved).
Percentages of subjects reported worse, same or better under each cycling setting since starting the study are presented."|4 weeks|24 subjects who first completed unique randomization sequences were included in the analysis.||Percent of Subjects|||Number
655002|NCT01957137|Secondary|Number of Pads Used Per Day - Randomized Portion|Number of pad use were collected through a diary on daily basis for approximately 4 weeks when subjects were under each cycling setting. Only the last 7-day diaries were used for the analysis. The first 3 weeks were used as an adjustment period.|4 weeks|24 subjects who first completed unique randomization sequences were included in the analysis.||Pads per day||95% Confidence Interval|Least Squares Mean
655003|NCT01957137|Secondary|Degree of Urgency - Randomized Portion|Each UUI episode was rated on following scales: 0=None, 1=Mild, 2=Moderate, 3=Severe, which were collected through a diary on daily basis for approximately 4 weeks when subjects were under each cycling setting. The average degree of urgency per UUI episode was calculated from the last 7-day diaries were used for the analysis. The first 3 weeks were used as an adjustment period.|4 week|24 subjects who first completed unique randomization sequences were included in the analysis.||units on a scale||95% Confidence Interval|Least Squares Mean
655004|NCT01957137|Primary|Number of Urinary Urge Incontinent (UUI) Episodes Per Day - Randomized Portion|Urinary urge incontinent episodes were collected through a diary on daily basis for approximately 4 weeks when subjects were under each cycling setting. Only the last 7-day diaries were used for the analysis. The first 3 weeks were used as an adjustment period.|4 weeks|24 subjects who first completed the unique randomization sequences were included in the analysis.||Number of UUI episodes/ Day||Standard Deviation|Mean
655005|NCT01957111|Secondary|Sleep Efficiency Percentage on Overnight Sleep Study|Participants will have their sleep measured with polysomnography for one night. The sleep of individuals with insomnia will be compared to that of good sleepers. Sleep quality is defined as sleep efficiency, which is calculated at total sleep time / total time spent in bed x 100. It indicates the % of time spent asleep while in bed.|1 night|||% sleep efficiency||Standard Deviation|Mean
655006|NCT01957111|Primary|Number of Metabolites Elevated Relative to the Other Group.|Metabolomics analysis of blood samples were carried out using Spectroscopy. This approach allows for rapid, unbiased and quantitative metabolic profiles ('fingerprints) to be acquired. A total of 70 metabolites were measured and compared between individuals with insomnia and good sleepers.|48 hours|||Number of metabolites elevated|||Number
655007|NCT01956240|Secondary|Scapular Kinematics After Pectoralis Minor Stretching Protocol|The scapular kinematics will be evaluated with electromagnetic device. The changes in the scapular kinematics will be described in degrees.|6 weeks of stretching|||degree||Standard Deviation|Mean
655008|NCT01956240|Primary|Pectoralis Minor Length After Pectoralis Minor Stretching Protocol|The change of the pectoralis minor muscle will be evaluated with a tape measure and electromagnetic device. The length of the muscle will be recorded in centimeters.|6 weeks after stretching|||centimeters||Standard Deviation|Mean
655009|NCT01956097|Secondary|Number of Participants With Adverse Events||8th weeks|"6 participants in the HX106 590mg group and 2 participant in the HX106 1180mg were dropped out."||number of participants|||Number
655010|NCT01956097|Secondary|Number of Participants With Adverse Events||4th weeks|"3 participants in the HX106 590mg group and 1 participant in the HX106 1180mg were dropped out."||number of participants|||Number
655011|NCT01956097|Secondary|Number of Participants With Adverse Events||1st week|"2 participants in the HX106 590mg group and 1 participant in the HX106 1180mg were dropped out."||number of participants|||Number
655012|NCT01956097|Primary|Changes From Baseline in White Matter Integrity Assessment||Baseline, 8th weeks||||||
655013|NCT01956097|Primary|Changes From Baseline in Working Memory Domain Z-score|"To assess the working memory performance, four well-established tests, including the symbol span from the Wechsler Memory Scale-IV, immediate recall domain from the Rey-Osterrieth Complex Figure Test, digit span, and letter number sequencing from the Korean version of the Wechsler Adult Intelligence Scale were chosen.
Each test score was adjusted with age, sex, intelligent quotient, years of education, and baseline test scores. The adjusted test scores were then standardized into z-scores using all participants' means and standard deviations. The relative improvement (positive z-scores) or decline (negative z-scores) in performance was measured in a unit-free manner using the obtained z-scores. The individual z-scores of each test were averaged to the composite score for working memory domain."|Baseline, 8th week|||z-score||Standard Error|Mean
655270|NCT01953081|Secondary|AUC|Area under the plasma concentration time curve from 0 to 72 hours after dosing.|72 hours|One subject did not receive the full dose of TD-8954 and was excluded from PK analysis for the TD-8954 group; Metoclopramide concentrations were not measured in the Metoclopramide group.||pg*hr/mL||Standard Deviation|Mean
655014|NCT01956032|Secondary|Median Time Spent for Health Care Utilization Outside the TM Care Chain|The time spent in minutes for health care utilization outside the TM care chain was assessed. Data are presented as time in minutes with a minimum and maximum range.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.||Minutes||Full Range|Median
655015|NCT01956032|Secondary|Number of Participants With Health Care Utilization Outside the TM Care Chain, Summarized by Type of Contact|The number of participants with health care utilization outside the TM care chain was assessed and summarized by type of contact (other, telephone, home or outpatient visit, and hospitalization).|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.||Number of participants|||Number
655016|NCT01956032|Secondary|Number of Participants With Health Care Utilization Outside the TM Care Chain, Summarized by Type of Health Care Provider|The number of participants with health care utilization outside the TM care chain was assessed and summarized by type of health care provider (general practitioner, emergency ward, other neurologist, and other).|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.||Number of participants|||Number
655017|NCT01956032|Secondary|Percentage of Participants With Clinical Global Impression – Improvement (CGI-I) in Parkinson’s Disease Symptoms|CGI-I was used to document the Investigator’s impression of the participant’s improvement in Parkinson's Disease symptoms throughout the study. The CGI-I was measured on a 7-point scale: 1=Very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; and 7=Very much worse, where 1 through 3 indicated positive answers. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.||Percentage of participants|||Number
655018|NCT01956032|Secondary|DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 14: How Satisfied Were You With Replacing the Participant Home Visit With TM Communication?|The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 14 (How satisfied were you with replacing the participant home visit with TM communication?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.||Percentage of participants|||Number
655019|NCT01956032|Secondary|Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 13: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Time for Other Tasks Between Contacts?|The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured as ‘more’, ‘equal’ or ‘less’ for question number 13 (Compared to classic titration at hospital - how much time did you spend on TM communication based on time for other tasks between contacts?) where ‘more’ indicated the most negative answer and ‘less’ indicated the most positive answer. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.||Percentage of participants|||Number
655020|NCT01956032|Secondary|Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 12: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Booked Communication Time for Participant Contact?|The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured as ‘more’, ‘equal’ or ‘less’ for question number 12 (Compared to classic titration at hospital - how much time did you spend on TM communication based on booked communication time for participant contact?) where ‘more’ indicated the most negative answer and ‘less’ indicated the most positive answer. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.||Percentage of participants|||Number
655021|NCT01956032|Secondary|Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 11: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Real Communication Time for Participant Contact?|The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured as ‘more’, ‘equal’ or ‘less’ for question number 11 (Compared to classic titration at hospital - how much time did you spend on TM communication based on real communication time for participant contact?) where ‘more’ indicated the most negative answer and ‘less’ indicated the most positive answer. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.||Percentage of participants|||Number
655271|NCT01953081|Secondary|Gastric Retention by Scintigraphy|Number of subjects with retention less than 13% at 180 minutes after dosing.|180 minutes|ITT||participants|||Number
655022|NCT01956032|Secondary|Positive (Investigator and DNS) Experience of Duodopa Home Titration Using TM Assessed by Question Number 10: Did You Lack Any Dimensions in the Assessment of the Participant Using TM That You Have in the Classical Titration at Hospital?|The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured as ‘yes’ or ‘no’ for question number 10 (Did you lack any dimensions in the assessment of the participant using TM that you have in the classical titration at hospital?) where ‘No’ indicated a positive answer. Data are presented as percentage of participants with positive experience, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.||Percentage of participants|||Number
655023|NCT01956032|Secondary|Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 9: How Satisfied Were You With the Participant Contact When Using TM?|The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 9 (How satisfied were you with the participant contact when using TM?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.||Percentage of participants|||Number
655024|NCT01956032|Secondary|Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 8: How Satisfied Were You Regarding Participant Safety Using TM?|The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 8 (How satisfied were you regarding participant safety using TM?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.||Percentage of participants|||Number
655025|NCT01956032|Secondary|Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 7: How Satisfied Were You With the Setup and Maintenance of the TM Equipment?|The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 7 (How satisfied were you with the setup and maintenance of the TM equipment?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.||Percentage of participants|||Number
655026|NCT01956032|Secondary|Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 6: How Satisfied Were You With the User Interphase for the TM Equipment?|The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 6 (How satisfied were you with the user interphase for the TM equipment?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.||Percentage of participants|||Number
655027|NCT01956032|Secondary|Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 5: How Satisfied Were You With the Sound Quality for Your Assessment of the Participant?|The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 5 (How satisfied were you with the sound quality for your assessment of the participant?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.||Percentage of participants|||Number
655028|NCT01956032|Secondary|Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 4: How Satisfied Were You With the Image Quality for Your Assessment of the Participant?|The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 4 (How satisfied were you with the image quality for your assessment of the participant?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.||Percentage of participants|||Number
655272|NCT01953081|Secondary|Tmax|Time to maximal concentration in plasma|72 hours|PK Analysis set for subjects receiving TD-8954, metoclopramide concentrations were not measured in the metoclopramide group.||hours||Full Range|Median
655273|NCT01953081|Primary|Adverse Events|the number of subjects reporting adverse events by treatment group|6 Days|Safety Population||participants|||Number
655029|NCT01956032|Secondary|Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 3: How Satisfied Were You With Using TM for Clinical Assessments?|The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 3 (How satisfied were you with using TM for clinical assessments?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.||Percentage of participants|||Number
655030|NCT01956032|Secondary|Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 2: How Satisfied Were You With Using TM for Communication?|The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 2 (How satisfied were you with using TM for communication?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.||Percentage of participants|||Number
655031|NCT01956032|Secondary|Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 1: How Satisfied Were You With the TM Concept Comports With Your Clinical Needs?|The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 1 (How satisfied were you with the TM concept comports with your clinical needs?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.||Percentage of participants|||Number
655032|NCT01956032|Secondary|Positive Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 16 for Caregiver: Knowing What You Know Now, Would You Rather Have Had Your Spouse in the Hospital to Start Duodopa Treatment?|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days. The experience of Duodopa home titration using TM was measured by the caregiver as ‘yes’ or ‘no’ for question number 16 (knowing what you know now, would you rather have had your spouse in the hospital to start Duodopa treatment?) where ‘No’ indicated a positive answer. Data are presented as percentage of participants with positive experience, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.||Percentage of participants|||Number
655033|NCT01956032|Secondary|Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 15 for Caregiver: How Confident Did You Feel About Helping With the Pump?|The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the caregiver on a scale from 1 to 7 for question number 15 (How confident did you feel about helping with the pump?) where 1 was ' Very unconfident’ and 7 was 'very confident'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.||Percentage of participants|||Number
655034|NCT01956032|Secondary|Positive Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 14 for Caregiver: Where You Able to Perform Daily Activities During the Titration Period?|The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the caregiver as ‘yes’ or ‘no’ for question number 14 (Where you able to perform daily activities during the titration period?) where ‘yes’ indicated a positive answer. Data are presented as percentage of participants with positive experience, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.||Percentage of participants|||Number
655035|NCT01956032|Secondary|Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 13 for Caregiver: How Satisfied Were You With the Titration at the Participant’s Home?|The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the caregiver on a scale from 1 to 7 for question number 13 (how satisfied were you with the titration at the participant’s home?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.||Percentage of participants|||Number
655274|NCT01952834|Secondary|Interleukin-12|This is a circulating plasma cytokine|Change before and after 6 weeks of probiotic|Subjects with plasma samples available pre and post probiotic supplementation||pg/mL||Standard Error|Mean
655275|NCT01952834|Secondary|Interleukin 8|Circulating cytokine measured in the plasma|Change before and after 6 weeks of daily Probiotic|||pg/mL||Standard Error|Mean
655036|NCT01956032|Secondary|Positive Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 12: Knowing What You Know Now, Would You Rather Have Stayed in the Hospital to Start Duodopa Treatment?|The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant as ‘yes’ or ‘no’ for question number 12 (Knowing what you know now, would you rather have stayed in the hospital to start Duodopa treatment?) where ‘No’ indicated a positive answer. Data are presented as percentage of participants with positive experience, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.||Percentage of participants|||Number
655037|NCT01956032|Secondary|Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 11: How Secure Did You Feel Being at Home and Communicating by TM, When Titrating Duodopa?|The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 11 (How secure did you feel being at home and communicating by TM, when titrating Duodopa?) where 1 was 'very unsecure’ and 7 was 'very secure'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.||Percentage of participants|||Number
655038|NCT01956032|Secondary|Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 10: How Confident do You Feel Regarding the Pump and the Dose Adjustments?|The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 10 (How confident do you feel regarding the pump and the dose adjustments?) where 1 was ' very unconfident’ and 7 was 'very confident'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.||Percentage of participants|||Number
655039|NCT01956032|Secondary|Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 9: How Satisfied Were You With the Technician’s Visits to Set up and Dismantle the TM Equipment?|The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 9 (How satisfied were you with the technician’s visits to set up and dismantle the TM equipment?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.||Percentage of participants|||Number
655040|NCT01956032|Secondary|Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 8: How Satisfied Were You With Having the Technical Equipment in Your Home?|The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 8 (How satisfied were you with having the technical equipment in your home?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.||Percentage of participants|||Number
655041|NCT01956032|Secondary|Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 7: How Satisfied Were You With the Amount of Time the DNS Were at Your Home?|The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 7 (How satisfied were you with the amount of time the DNS were at your home?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.||Percentage of participants|||Number
655042|NCT01956032|Secondary|Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 6: How Satisfied Were You With the 3-part Video Conversations (Both Investigator and DNS)?|The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 6 (How satisfied were you with the 3-part video conversations with Investigator and DNS?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.||Percentage of participants|||Number
656142|NCT01940120|Secondary|Freedom From Death and Mitral Valve Surgery||3 years|Analysis population includes 40 participants, which represents the number of patients at risk as per Kaplan-Meier analysis at 36 months.||participants|||Number
655043|NCT01956032|Secondary|Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 5: How Satisfied Were You With the Video Conversation With Your DNS?|The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 5 (How satisfied were you with the video conversation with your DNS?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.||Percentage of participants|||Number
655044|NCT01956032|Secondary|Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 4: How Satisfied Were You With the Video Conversation With Your Investigator?|The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 4 (How satisfied were you with the video conversation with your Investigator?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.||Percentage of participants|||Number
655045|NCT01956032|Secondary|Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 3: How Easy Was the TM Equipment to Use?|The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 3 (How easy was the TM equipment to use?) where 1 was 'very hard' and 7 was 'very easy'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.||Percentage of participants|||Number
655046|NCT01956032|Secondary|Positive Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 2: Did You do Things When at Home That You Could Not Have Done if You Were Hospitalized During the Titration?|The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant as ‘yes’ or ‘no’ for question number 2 (Did you do things when at home that you could not have done if you were hospitalized during the titration?) where ‘yes’ indicated a positive answer. Data are presented as percentage of participants with positive experience, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.||Percentage of participants|||Number
655047|NCT01956032|Secondary|Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 1: How Satisfied Were You With Using TM When Starting Duodopa?|The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 1 (How satisfied were you with using TM when starting Duodopa?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.||Percentage of participants|||Number
655048|NCT01956032|Secondary|Incidence of Technical Events Experienced by Participants, Summarized by Type of Consequence|Technical events were defined as: any technical event; type A: TM equipment – mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link). Data are summarized by type of consequence (contact delay, re-establishment of connection, TM-call replaced by telephone call, failed scheduled contact, and other consequence) and the percentage was calculated based on the total number of technical events (34).|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.||Percentage of technical events|||Number
655049|NCT01956032|Secondary|Percentage of Participants Who Experienced Technical Events, Summarized by Type of Consequence|Technical events were defined as: any technical event; type A: TM equipment – mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link). Data are summarized by type of consequence (contact delay, re-establishment of connection, TM-call replaced by telephone call, failed scheduled contact, and other consequence) and the percentage was calculated based on the number of participants in the FAS population.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.||Percentage of participants|||Number
655066|NCT01955707|Secondary|Barthel Index at Day 5, Day 30, and Day 90|The Barthel Index consists of 10 items that measure a person’s daily functioning, specifically the activities of daily living and mobility, and can be used to determine a baseline level of functioning and to monitor change in activities of daily living over time. The scores for each of the items are summed to create a total score up to a potential of 100, with higher scores representing a greater level of independence.|Day 5, Day 30, and Day 90|Modified intention to treat (all participants who were randomized and received the entire infusion of study treatment); n=participants with assessment at given time point.||units on a scale||Full Range|Median
655050|NCT01956032|Secondary|Incidence of Consequences Due to Technical Events|Consequences due to technical events were defined as: any consequence, contact delay, re-establishment of connection, TM-call replaced by telephone call, failed scheduled contact, and other consequence. Data are summarized by type of technical event (type A: TM equipment – mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link) and the percentage was calculated based on the total number of consequences (43).|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.||Percentage of consequences|||Number
655051|NCT01956032|Secondary|Percentage of Participants With Consequences|Consequences due to technical events were defined as: any consequence, contact delay, re-establishment of connection, TM-call replaced by telephone call, failed scheduled contact, and other consequence. Data are summarized by type of technical event (type A: TM equipment – mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link) and the percentage was calculated based on the number of participants in the FAS population.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.||Percentage of participants|||Number
655052|NCT01956032|Secondary|Incidence of Technical Events Experienced by Participants|Technical events were defined as: any technical event; type A: TM equipment – mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link. Technical problems were defined as: failure to answer video call, Intentional failure to answer video call, mechanical, electrical, failure to establish connection, interruptions, transmission quality, sound quality, image quality, and others. The percentage was calculated based on the total number of technical events (34).|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.||Percentage of technical events|||Number
655053|NCT01956032|Secondary|Percentage of Participants Who Experienced Technical Events|Technical events were defined as: any technical event; type A: TM equipment – mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link. Technical problems were defined as: failure to answer video call, Intentional failure to answer video call, mechanical, electrical, failure to establish connection, interruptions, transmission quality, sound quality, image quality, and others. The percentage was calculated based on the number of participants in the FAS population.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.||Percentage of participants|||Number
655054|NCT01956032|Secondary|Median Total Free Time of Participant|Participant’s daily free time was a maximum 24 hours, and was defined as the time spent on activities (e.g. work, household, chores, leisure time, travel, sleep, etc.) other than time spent on health care professional (the DNS and the Investigator) communication, dose adjustments and pump handling. Time for dose adjustments, health care professional communication via TM and pump handling were subtracted from the amount of participant’s daily free time. The participant was asked to note the time used for independent dose adjustments and pump handling in a participant diary. Participant’s total free time was calculated as the sum of participant’s daily free time for all days during the titration period. Data are presented as time in minutes per participant with a minimum and maximum range.|From Day 1 (start of the pump after application of the naso-jejunal tube) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.||Minutes||Full Range|Median
655055|NCT01956032|Secondary|Median Total Time for Titration|The total time for titration period was defined as the number of minutes from the start of the pump after application of the naso-jejunal tube (Day 1) until Investigator’s decision to terminate Duodopa treatment. Data are presented as time in minutes per participant with a minimum and maximum range.|From Day 1 (start of the pump after application of the naso-jejunal tube) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.||Minutes||Full Range|Median
655056|NCT01956032|Primary|Median Number of Contacts|Contacts (total, TM, telephone, home visit, and other) during the study period between the participant, the health care professional (the DNS and the Investigator) and TM technician were counted and summarized by type. Data are presented as number of contacts per participant with a minimum and maximum range.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.||Number of contacts||Full Range|Median
655057|NCT01956032|Primary|Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant|Health care professional time was defined as the number of minutes the individual had contact with the participant visiting their home, assisting with TM equipment, or by telephone. TM technician time was defined as the number of minutes spent for setup, demounting, and adjustments to the TM equipment. Data are presented as the time in minutes for communication between the following individuals and summarized by the type of contact (all types, TM, telephone, home visit, and other): (1) Participant + Investigator time; (2) Participant + DNS time; (3) Participant + Investigator + DNS time; (4) Participant + TM technician time; (5) Total Investigator time; (6) Total DNS time; and (7) Total participant time.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using full analysis set (FAS), defined as all participants that started Duodopa titration.||Minutes||Full Range|Median
655080|NCT01955629|Secondary|Part 2: Progression Free Survival (PFS)|PFS was defined as the time interval from the date of registration into the study to the date of first observation of DP or death (due to any cause), whichever was first.|From the date of enrollment up to the date of DP or death, whichever occurred first (up to 15 months).|Due to premature recruitment discontinuation, none of the planned efficacy analyses was performed.|||||
655058|NCT01955720|Secondary|Ae0-6 (Amount of Ida Eliminated in Urine From the Time Point 0 to Time Point 6 h)|"Ae0-6 (Amount of Ida Eliminated in Urine From the Time Point 0 to Time point 6 h).
PK Urine sampling time:
Urine sampling relative to DE administration: Planned times 72:00 - 73:55h, 73:55 - 80:00h, 80:00 - 86:00h, 86:00 - 98:00h, 98:00 - 122:00h, 122:00 - 146:00h; additional sampling for renal impaired: 146:00 - 170:00; 170:00 - 194:00h."|from 0 to 6 hours of post Ida dose (details in description)|PKS-Ida: The PKS-Ida included all treated subjects who have received at least 1 dose of idarucizumab and who provided data for at least 1 secondary or other PK endpoint in any treatment period, which was judged as evaluable for PK and was not affected by (important) protocol violations relevant to the statistical evaluation of PK endpoints.||umol||Geometric Coefficient of Variation|Geometric Mean
655059|NCT01955720|Secondary|Cmax (Maximum Measured Concentration of the Ida in Plasma)|"Cmax. PK/PD sampling time: (p=predose, D=day)
single medium or high dose, HS mid-age (45-64 yrs): D4: 8:55p, 9:00,9:10,9:30,10:00,11:00,13:00,15:00,19:00,21:00,01:00; D5: 9:00p, 21:00. D6: 9:00.
single low or high dose, healthy elderly or mild RI: D4: 8:55p, 9:00,9:10,9:30,10:00,11:00,13:00,15:00,19:00,21:00,01:00; D5: 9:00; D6: 9:00; D7: 9:00; additional sampling for RI: D8: 9:00;D9: 9:00.
high 2 doses, moderate RI: D4: 8:55p, 9:00, 9:10,9:30,9:55p, 10:00,10:10,10:30,11:00, 13:00, 15:00, 19:00, 21:00, 01:00; D5: 9:00; D6: 9:00; D7: 9:00; additional sampling for RI: D8:9:00; D9:9:00."|From Ida administration to 4 days post dose (details in description)|PKS-Ida||nmol/L||Geometric Coefficient of Variation|Geometric Mean
655060|NCT01955720|Secondary|Aet1-t2, ss (Amount of DE Eliminated in Urine From the Time Point t1 to Time Point t2)|"Urinary excretion of sum dabigatran from the time point t1 to t2 at steady state.
PK Urine sampling time:
Urine sampling relative to first DE administration: Planned times 72:00 - 73:55h, 73:55 - 80:00h, 80:00 - 86:00h, 86:00 - 98:00h, 98:00 - 122:00h, 122:00 - 146:00h; additional sampling for renal impaired: 146:00 - 170:00; 170:00 - 194:00h.
Ae0-26,ss was not measured in Period 3 (re-exposure period). Ae0-74,ss was not measured in healthy subjects aged 45 to 64 years."|From 0 to 74h post of last DE dose (details in description)|Pharmacokinetic Set - DE (PKS-DE): The PKS-DE included all treated subjects who have received at least 1 dose of DE and who provided data for at least 1 secondary or further PK endpoint in any treatment period, which was judged as evaluable for PK and was not affected by protocol violations relevant to the statistical evaluation of PK endpoints.||μg||Geometric Coefficient of Variation|Geometric Mean
655061|NCT01955720|Secondary|AUC2-12, ss (Area Under the Concentration-time Curve of Unbound Sum Dabigatran (DE) in Plasma at Steady State Over the Time Interval From 2 to 12h)|"PK/PD sampling time:(d=dose,D=Day,p=predose)
single medium or high dose,healthy, mid-age (45-64 yrs): D4: 7:00p,8:55p,9:00,9:10,9:30,10:00,11:00,13:00,15:00,19:00,21:00, 01:00; D5:9:00p,11:00,21:00p; D6:9:00p, 21:00p; D7:9:00p, 11:00.
single low or high dose,healthy elder or mild renal impaired: D4:7:00p,8:55p,9:00,9:10,9:30,10:00,11:00,13:00,15:00,19:00,21:00,01:00;D5:9:00;D6:9:00;D7:9:00; additional sampling for renal impaired: D8:9:00;D9:9:00.
high 2 doses, moderate renal impaired: D4:7:00p,8:55p,9:00,9:10,9:30,9:55p,10:00,10:10,10:30,11:00,13:00,15:00,19:00,21:00,01:00;D5:9:00;D6:9:00; D7:9:00; additional sampling for renal impaired: D8:9:00;D9:9:00."|from 2h to12h of post DE dose at steady state (details in description)|PKS-DE: The PKS-DE included all treated subjects who have received at least 1 dose of DE and who provided data for at least 1 secondary or further PK endpoint in any treatment period, which was judged as evaluable for PK and was not affected by (important) protocol violations relevant to the statistical evaluation of PK endpoints.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
655062|NCT01955720|Secondary|AUC0-infinity (Area Under the Concentration-time Curve of Idarucizumab (Ida) in Plasma Over the Time Interval From 0 Extrapolated to Infinity)|"AUC0-infinity. PK/PD sampling time: (p=predose, D=day)
single medium or high dose, healthy subjects(HS) mid-age (45-64 yrs): D4: 8:55p, 9:00,9:10,9:30,10:00,11:00,13:00,15:00,19:00,21:00,01:00; D5: 9:00p, 21:00. D6: 9:00.
single low or high dose, HS elderly or mild renal impaired: D4: 8:55p, 9:00,9:10,9:30,10:00,11:00,13:00,15:00,19:00,21:00,01:00; D5: 9:00; D6: 9:00; D7: 9:00; additional sampling for renal impaired: D8: 9:00;D9: 9:00.
high 2 doses, moderate renal impaired: D4: 8:55p, 9:00, 9:10,9:30,9:55p, 10:00,10:10,10:30,11:00, 13:00, 15:00, 19:00, 21:00, 01:00; D5: 9:00; D6: 9:00; D7: 9:00; additional sampling for renal impaired: D8:9:00; D9:9:00."|From Day 4 to Day 9 (details in description)|Pharmacokinetic Set -Ida (PKS-Ida): included all treated subjects who have received at least 1 dose of idarucizumab and who provided data for at least 1 secondary or other PK endpoint in any treatment period, which was judged as evaluable for PK and was not affected by protocol violations relevant to the statistical evaluation of PK endpoints.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
655063|NCT01955720|Primary|The Percentage of Subjects With Drug-related Adverse Events|The percentage of subjects with possibly drug-related AEs (as defined by the investigator) during the treatment period.|From baseline up to the start of follow-up period (from Day 1 to Day 35)|Treated Set (TS): All randomised subjects who received at least 1 dose of trial medication were included in the treated set.||percentage of participants|||Number
655064|NCT01955720|Primary|Reversal of Dabigatran-induced Prolongation of Blood Coagulation Time|Percentage of subjects with at least one assay value from diluted thrombin time (dTT) or ecarin clotting time (ECT) reversed within 10min after completion of infusion. Reversal was defined as return to baseline, where the threshold for reversal to baseline was determined using PK/PD correlation between unbound sum dabigatran and the clotting parameters ECT and dTT. Measured at the end of the infusion and 10 min later.|End of last infusion and 10 minutes after completion of last infusion of BI 655075|PD Set (PDS): The PDS included all subjects from the TS who had at least 1 evaluable predose and on-treatment coagulation test measurement value for at least 1 coagulation test and who did not have important protocol violation relevant to the evaluation of PD.||percentage of participants|||Number
655065|NCT01955707|Secondary|Number of Participants Who Experience Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: any untoward medical occurrence that does not necessarily have a causal relationship with this treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above. Events were categorized as severe, moderate, or mild, and related or not related to study treatment.|Up to Day 90 ± 5 days|Safety population (all participants who were randomized and received any portion of the infusion of study treatment).||participants|||Number
655067|NCT01955707|Secondary|Modified Rankin Scale (mRS) Distribution at Day 5, Day 30, and Day 90|The mRS measures independence, rather than neurologic function, with specific tasks pre- and post-stroke, respectively. The scale consists of 7 grades, from 0 to 6, with 0 corresponding to no symptoms and 6 corresponding to death. The distribution of mRS scores was summarized at each timepoint. An excellent outcome on the mRS was defined as a score of 0 or 1, while a good outcome was defined as a score of 0, 1, or 2.|Day 5, Day 30, and Day 90|Modified intention to treat (all participants who were randomized and received the entire infusion of study treatment), using imputed data; n=number of participants with an assessment at given time point.||participants|||Number
655068|NCT01955707|Secondary|Change in National Institute of Health Stroke Scale (NIHSS) Score From Baseline to 24 Hours, Day 5, Day 30, and Day 90|The NIHSS is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Scores for the NIHSS range from 0 to 42, with 0 representing no symptoms and 42 representing death.|Baseline, 24 hours, Day 5, Day 30, Day 90|Modified intention to treat (all participants who were randomized and received the entire infusion of study treatment); n=participants with assessments at Baseline and given time point.||units on a scale||Standard Deviation|Mean
655069|NCT01955707|Secondary|Change in Infarct Volume From Day 5 (FLAIR) to Day 30 (FLAIR)|Relative growth of infarct volume from Day 5 (relative growth = FLAIR at Day 30 divided by FLAIR at Day 5). Geometric mean calculated as the exponential of the mean log relative growth.|Day 5, Day 30|Modified intention to treat (all participants who were randomized and received the entire infusion of study treatment) with assessments at both time points.||mL||Inter-Quartile Range|Geometric Mean
655070|NCT01955707|Secondary|Change in Infarct Volume From 24 Hours (FLAIR) to Day 30 (FLAIR)|Relative growth in infarct volume from Baseline (relative growth = FLAIR Day 30 divided by FLAIR at 24 hours ). Geometric mean calculated as the exponential of the mean log relative growth.|24 hours, Day 30|Modified intention to treat (all participants who were randomized and received the entire infusion of study treatment) with assessments at both time points.||mL||Inter-Quartile Range|Geometric Mean
655071|NCT01955707|Secondary|Change in Infarct Volume From 24 Hours (FLAIR) to Day 5 (FLAIR)|Relative growth of infarct volume from 24 hours (relative growth = FLAIR at Day 5 divided by FLAIR at 24 hours). Geometric mean calculated as the exponential of the mean log relative growth.|24 hours, Day 5|Modified intention to treat (all participants who were randomized and received the entire infusion of study treatment) with assessments at both time points.||mL||Inter-Quartile Range|Geometric Mean
655072|NCT01955707|Secondary|Change in Infarct Volume From Baseline (DWI) to Day 30 (FLAIR)|Relative growth of infarct volume from Baseline (relative growth = FLAIR at Day 30 divided by Baseline DWI). Geometric mean calculated as the exponential of the mean log relative growth.|Baseline, Day 30|Modified intention to treat (all participants who were randomized and received the entire infusion of study treatment) with assessments at both time points.||mL||Inter-Quartile Range|Geometric Mean
655073|NCT01955707|Secondary|Change in Infarct Volume From Baseline (DWI) to 24 Hours (FLAIR)|Relative growth of infarct volume from Baseline (relative growth = FLAIR at 24 hours divided by Baseline DWI). Geometric mean calculated as the exponential of the mean log relative growth.|Baseline, 24 hrs|Modified intention to treat (all participants who were randomized and received the entire infusion of study treatment) with assessments at both time points.||mL||Inter-Quartile Range|Geometric Mean
655074|NCT01955707|Primary|Change in Infarct Volume From Baseline (Diffusion-Weighted Imaging [DWI]) to Day 5 (Fluid-Attenuated Inversion Recovery [FLAIR])|Relative growth of infarct volume from Baseline (relative growth = FLAIR at Day 5 divided by Baseline DWI). Geometric mean calculated as the exponential of the mean log relative growth.|Baseline, Day 5|Modified intention to treat (all participants who were randomized and received the entire infusion of study treatment) with assessments at both time points.||mL||Inter-Quartile Range|Geometric Mean
655075|NCT01955629|Secondary|Part 2: Aflibercept Biomarkers Evaluation|Blood and tumor samples were to be collected to evaluate proteomic biomarkers such as factors and receptors related to angiogenesis process, inflammation, and tumor progression.|Baseline (within 21 days before registration); Day 1/pre-dose of Cycle 1, 2 and 3 of induction phase and maintenance phase; 30 ± 3 days after the last aflibercept administration.|Due to premature recruitment discontinuation, no samples had been collected and none of the planned biomarker analyses was performed.|||||
655076|NCT01955629|Secondary|Part 2: Pharmacodynamic Parameters: Modulation of Circulating Analytes|Blood and tumor samples were to be collected to evaluate the pharmacodynamic parameters including the assessment of the modulation of circulating analytes such as cytokines and angiogenic factors.|Baseline (within 21 days before registration); Day 1/pre-dose of Cycle 1, 2 and 3 of induction phase and maintenance phase; 30 ± 3 days after the last aflibercept administration.|Due to premature recruitment discontinuation, no samples had been collected and none of the planned efficacy/pharmacodynamic analyses was performed.|||||
655077|NCT01955629|Secondary|Part 2: Number of Participants With CR or PR|Tumor assessment was performed by abdomino-pelvic computed tomography scan or MRI and chest X-ray or chest CT-scan to assess the disease status at baseline and then every 9 weeks during study treatment up to DP. Target lesions were evaluated using RECIST version 1.1, wherein CR = disappearance of all target lesions; PR = 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.|Baseline and every 9 weeks up to end of study completion (15 months).|Due to premature recruitment discontinuation, none of the planned efficacy analyses was performed.|||||
655078|NCT01955629|Secondary|Part 2: Overall Rate of Resectability of Metastatic Lesions|Overall metastases resection rate was defined as the percentage of participants reaching an R0 metastases resection, defined as the complete absence of invasive carcinoma on histological examination at the time of definitive surgery.|12 months after the last participant enrolled.|Due to premature recruitment discontinuation, none of the planned efficacy analyses was performed.|||||
655079|NCT01955629|Secondary|Part 2: Overall Survival (OS)|OS was defined as the time interval from the date of registration into the study to the date of death due to any cause. In the absence of confirmation of death, survival time was to be censored at the earliest between the last date the participant was known to be alive and the end of study date.|From the date of enrollment up to the date of death (up to 15 months).|Due to premature recruitment discontinuation, none of the planned efficacy analyses was performed.|||||
656143|NCT01940120|Secondary|Freedom From Mitral Valve Surgery||36 months|Analysis population includes 40participants, which represents the number of patients at risk as per Kaplan-Meier analysis at 36 months.||participants|||Number
655081|NCT01955629|Secondary|Part 1: Number of Participants With Tumor Responses (Complete Response [CR], Partial Response [PR], Stable Disease [SD] or Progressive Disease [PD])|Tumor assessment was performed by abdomino-pelvic computed tomography scan or magnetic resonance imaging (MRI) and chest X-ray or chest CT-scan to assess the disease status at baseline and then every 9 weeks during study treatment up to DP. Target lesions were evaluated using response evaluation criteria in solid tumors (RECIST) version 1.1, wherein CR = disappearance of all target lesions; PR = 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD; PD =20% increase in the sum of the LD of target lesions taking as reference the smallest sum in the study and SD = small changes that did not meet above criteria.|Baseline and every 9 weeks up to DP (up to 15 months).|Evaluable Population (EP) for tumor response was defined as a subset of ITT population (all participants who gave their informed consent and successfully registered into study) with measurable disease at study entry, who received at least 1 cycle of study treatment, with at least 1 post baseline tumor evaluation, except for early DP or death.||Participants|||Number
655082|NCT01955629|Primary|Part 2: Number of Participants With Progression Free Survival (PFS) at 6 Months After the Start of Maintenance Therapy|It describes the number of participants alive without progression at 6 months after the start of Aflibercept maintenance therapy.|6 months after the start of maintenance therapy.|Due to premature recruitment discontinuation, none of the planned efficacy analyses was performed.|||||
655083|NCT01955629|Primary|Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)|DLTs were assessed using the national cancer institute (NCI) common terminology criteria for adverse events (CTCAE) version 4.03. DLTs were defined as any of following AEs: grade 4 neutropenia lasting >7 consecutive days; febrile neutropenia or neutropenic infection; grade 4 thrombocytopenia; grade 3 thrombocytopenia associated with bleeding requiring transfusion; grade 4 non-hematological treatment related event; grade 3 nausea/vomiting or diarrhea lasting >/= 4 days despite corrective measures; grade 3 other non-hematological toxicities: anorexia, fatigue, hypertension only if G4 or not medically controlled and G3 peripheral sensory neuropathy that did not improve to G<2 at time of retreatment; urinary protein excretion of >3.5 gram per 24 hours that did not recover to <2.0 gram per 24 hours within 2 weeks; symptomatic arterial thromboembolic events including cerebrovascular accidents, myocardial infarction, transient ischemic attacks, new onset or worsening of pre-existing angina.|Cycle 1 (Up to 3 weeks)|Evaluable DLT population defined as the subset of the whole part 1 participants that were exposed to at least 1 dose (even incomplete) of the study treatment and had a DLT assessment at Cycle 1.||Participants|||Number
655084|NCT01955564|Secondary|Total Drug Exposure Over Time (AUC0-t) of NW-3509A at Doses Tested|"Plasma concentration data, derived PK parameters, and urine data were summarized as total drug exposure over time (AUC0-t).
The plasma concentrations of NW‑3509A in the samples taken from the subjects receiving placebo were below the limit of quantification (<1.00 ng/mL) in all cases (n=18)."|Baseline up to 32 hours post-dose|||ng.h/mL||Standard Deviation|Mean
655085|NCT01955564|Secondary|Maximum Plasma Concentration of NW-3509A at Doses Tested|"Plasma concentration data, derived PK parameters, and urine data are summarized as maximum plasma concentration (Cmax).
The plasma concentrations of NW‑3509A in the samples taken from the subjects receiving placebo were below the limit of quantification (<1.00 ng/mL) in all cases (n=18)."|Baseline up to 32 hours post-dose|||ng/mL||Standard Deviation|Mean
655086|NCT01955564|Primary|Physical Examination Shift Table|Physical examinations were carried out on the following: Lymph nodes, mouth, neck, nervous system, nose, skin and throat.|Day -1(pre-dose) through Day 8 (Discharge)|||Participants abnormal at end of study|||Number
655087|NCT01955473|Secondary|Percentage of Participants With EGFR Amplification Using Fluorescent in Situ Hybridization (FISH) Method.||Week 1 (pre-dose) and Week 4.|The Biomarker analysis set consisted of all subjects who received at least 1 administration of Sym004 and who had at least 1 biomarker evaluation.||percentage of subjects|||Number
655088|NCT01955473|Secondary|Percentage of Participants With Epidermal Growth Factor Receptor (EGFR) Expression in Skin Tissues by Immunohistochemistry (IHC)|IHC is a staining process performed on fresh/frozen cancer tissue. IHC is used to show whether or not the cancer cells have Human Epidermal Growth Receptor (HER2) and/or hormone receptors on their surface. A value designated the IHC score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.|Week 1 (pre-dose), Week 4 and Week 5|The Biomarker analysis set consisted of all subjects who received at least 1 administration of Sym004 and who had at least 1 biomarker evaluation.||percentage of subjects|||Number
655089|NCT01955473|Secondary|Anti-drug Antibody Titers||Week 1 (pre-dose) up to Follow-up assessment (up to maximum 45.1 Weeks)|Anti-drug Antibody (ADA) titer could not be estimated because there were no subjects who were confirmed to have ADA positive test results during the confirmatory analysis.|||||
655090|NCT01955473|Secondary|Progression-free Survival Time|The Progression-free survival time was measured from the date of subject enrollment until the date that disease progression was objectively documented or death. Progression-free survival time estimated with using the Kaplan-Meier method. Progression-free survival time was planned to be reported for Part B alone and Part A/B combined reporting arms.|Time from enrollment until the date of objectively documented disease progression or death, up to 45.1 Weeks|Efficacy Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who had baseline tumor assessment and at least 1 tumor assessment according to RECISTv1.1 after first dose of trial medication.||months||95% Confidence Interval|Median
655091|NCT01955473|Secondary|Time to Progression|Time to progression was defined as the time from date of subject enrollment until the date that disease progression was objectively documented. TTP estimated using the Kaplan-Meier estimates. TTP was planned to be reported for Part B alone and Part A/B combined reporting arms.|Time from enrollment until the date of objectively documented disease progression or death, up to 45.1 Weeks|Efficacy Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who had baseline tumor assessment and at least 1 tumor assessment according to RECISTv1.1 after first dose of trial medication.||months||95% Confidence Interval|Median
655311|NCT01952665|Primary|Lens Preference, Pair 1 Lotrafilcon B|Participant preference for habitual lenses or study lenses with regard to comfort, dryness, handling, vision and overall. Collected at 2 weeks for study pair 1. (Randomized to lotrafilcon B as pair 1; Forced choice: Pair 1 or Habitual )|2 weeks|||participants|||Number
655092|NCT01955473|Secondary|Duration of Disease Control|Duration of disease control measured from the time measurement criteria were first met for CR, PR, or SD (whichever was first recorded) until the first date that recurrent or progressive disease was objectively documented. CR: disappearance of all target and all non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or unequivocal progression of existing non-target lesions. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|Week 7 and thereafter every 6 weeks until the first date of objectively documented recurrent or progressive disease, up to 45.1 weeks|Efficacy Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who had baseline tumor assessment and at least 1 tumor assessment according to RECISTv1.1 after first dose of trial medication. Here, “Number of Participants Analyzed” signifies those subjects who achieved disease control.||Weeks||Full Range|Median
655093|NCT01955473|Secondary|Percentage of Subjects With Disease Control|Percentage of subjects with disease control (defined as confirmed CR, confirmed PR, or confirmed SD) ) according to RECIST Version 1.1 was reported. CR: disappearance of all target and all non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or unequivocal progression of existing non-target lesions. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Confirmed CR or PR: response confirmed at an interval of at least 4 weeks. Confirmed SD: response confirmed at an interval of at least 6 weeks.|Week 7 and thereafter every 6 weeks, up to 4 weeks after last dose for Part A or up to 8 weeks after the last dose for Part B (up to 45.1 Weeks)|Efficacy Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who had baseline tumor assessment and at least 1 tumor assessment according to RECISTv1.1 after first dose of trial medication.||percentage of subjects||95% Confidence Interval|Number
655094|NCT01955473|Secondary|Duration of Overall Response|The duration of overall response was measured from the time measurement criteria were first met for CR or PR (whichever was first recorded) until the first date that recurrent or progressive disease was objectively documented. CR was defined as disappearance of all target and all non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. Confirmed CR or PR was defined as the response that was confirmed at an interval of at least 4 weeks.|Week 7 and thereafter every 6 weeks until the first date of objectively documented recurrent or progressive disease, up to 45.1 Weeks|Efficacy Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who had baseline tumor assessment and at least 1 tumor assessment according to RECISTv1.1 after first dose of trial medication. Here, “Number of Participants Analyzed” signifies those subjects who achieved confirmed CR or PR.||Weeks||Full Range|Median
655095|NCT01955473|Secondary|Percentage of Subjects With Best Overall Response|Percentage of subjects with best overall response (defined as confirmed CR or PR) according to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) was reported. CR was defined as disappearance of all target and all non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimiter (mm). PR was defined as at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. Confirmed CR or PR was defined as the response that was confirmed at an interval of at least 4 weeks.|Week 7 and thereafter every 6 weeks, up to 4 weeks after last dose for Part A or up to 8 weeks after the last dose for Part B (up to 45.1 Weeks)|Efficacy Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who had baseline tumor assessment and at least 1 tumor assessment according to RECISTv1.1 after first dose of trial medication.||percentage of subjects|||Number
655096|NCT01955473|Secondary|Time to Reach Maximum Concentration (Tmax) of Sym004 for the Biweekly Regimen at Week 5: Multiple Dose|Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Tmax are presented for both monoclonal antibodies. Weekly dosing cohorts (Part A: Sym004 6 mg/kg, Part A: Sym004 9/6 mg/kg, Part A: Sym004 12 mg/kg, Part B: Sym004 12 mg/kg) were not applicable for Week 5 assessment. Biweekly dosing cohort (Part A: Sym004 18 mg/kg) was only applicable for Week 5 assessment.|Pre-infusion, end of infusion, 4, 8, 12, 24 hours post-infusion at Week 5|The PK Analysis Set consisted of all subjects who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004.||hours||Full Range|Median
655097|NCT01955473|Secondary|Time to Reach Maximum Concentration (Tmax) of Sym004 for the Weekly Regimen at Week 4: Multiple Dose|Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Tmax are presented for both monoclonal antibodies. Weekly dosing cohorts (Part A: Sym004 6 mg/kg, Part A: Sym004 9/6 mg/kg, Part A: Sym004 12 mg/kg, Part B: Sym004 12 mg/kg) were only applicable for Week 4 assessment. Biweekly dosing cohort (Part A: Sym004 18 mg/kg) was not applicable for Week 4 assessment.|Pre-infusion, end of infusion, 4, 8, 12, 24 hours post-infusion at Week 4|"The PK Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here Number of Participants Analyzed signifies those subjects who were evaluable for this outcome measure."||hours||Full Range|Median
655276|NCT01952834|Primary|Brachial Artery Flow Mediated Dilation|Flow Mediated Dilation is measured as the percent change in brachial artery diameter as measured by high resolution ultrasound based on arterial diameter prior to and following 5 minute flow occlusion to the forearm . We measured the percent change in brachial diameter before vancomycin was started and again 10 days after vancomycin|Change before and after 10 days of Vancomycin, approximately 12 weeks from baseline|Subgroup analyzed who volunteered to have vancomycin||percent change||Standard Deviation|Mean
655098|NCT01955473|Secondary|Time to Reach Maximum Concentration (Tmax) of Sym004 at Week 1: Single Dose|Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Tmax are presented for both monoclonal antibodies.|Pre-infusion, end of infusion, 4, 8, 12, 24, 48 hours post-infusion at Week 1|"The PK Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here Number of Participants Analyzed signifies those subjects who were evaluable for this outcome measure."||hours||Full Range|Median
655099|NCT01955473|Secondary|Trough Concentrations (Ctrough) of Sym004|Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Ctrough are presented for both monoclonal antibodies.|Pre-infusion at Week 2, 3, 5, 6, 7, 8, End of Trial (up to 41.1 weeks) and Follow up (up to 45.1 Weeks)|"The PK Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here Number of Participants Analyzed =subjects who were evaluable for this outcome and n =subjects who were evaluable for specified time frame."||μg/mL||Standard Deviation|Mean
655100|NCT01955473|Secondary|Dose Normalized Maximum Serum Concentration (Cmax) of Sym004 for the Biweekly Regimen at Week 5: Multiple Dose|Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Here dose normalized Cmax are presented for both monoclonal antibodies. Weekly dosing cohorts (Part A: Sym004 6 mg/kg, Part A: Sym004 9/6 mg/kg, Part A: Sym004 12 mg/kg, Part B: Sym004 12 mg/kg) were not applicable for Week 5 assessment. Biweekly dosing cohort (Part A: Sym004 18 mg/kg) was only applicable for Week 5 assessment. Dose normalized Cmax was calculated as Cmax/Dose.|Pre-infusion, end of infusion, 4, 8, 12, 24 hours post-infusion at Week 5|The PK Analysis Set consisted of all subjects who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004.||μg/mL/mg||Geometric Coefficient of Variation|Geometric Mean
655101|NCT01955473|Secondary|Dose Nornamized Maximum Serum Concentration (Cmax) of Sym004 for the Weekly Regimen at Week 4: Multiple Dose|Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Here dose normalized Cmax are presented for both monoclonal antibodies. Dose normalized Cmax was calculated as Cmax/Dose. Weekly dosing cohorts (Part A: Sym004 6 mg/kg, Part A: Sym004 9/6 mg/kg, Part A: Sym004 12 mg/kg, Part B: Sym004 12 mg/kg) were only applicable for Week 4 assessment. Biweekly dosing cohort (Part A: Sym004 18 mg/kg) was not applicable for Week 4 assessment.|Pre-infusion, end of infusion, 4, 8, 12, 24 hours post-infusion at Week 4|"The PK Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here Number of Participants Analyzed signifies those subjects who were evaluable for this outcome measure."||μg/mL/mg||Geometric Coefficient of Variation|Geometric Mean
655102|NCT01955473|Secondary|Dose Normalized Maximum Serum Concentration (Cmax) of Sym004 at Week 1: Single Dose|Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Dose Normalized Cmax are presented for both monoclonal antibodies. Dose normalized Cmax was calculated as Cmax/Dose.|Pre-infusion, end of infusion, 4, 8, 12, 24, 48 hours post-infusion at Week 1|"The PK Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here Number of Participants Analyzed signifies those subjects who were evaluable for this outcome measure."||μg/mL/mg||Geometric Coefficient of Variation|Geometric Mean
655103|NCT01955473|Secondary|Maximum Serum Concentration (Cmax) of Sym004 for the Biweekly Regimen at Week 5: Multiple Dose|Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Cmax are presented for both monoclonal antibodies. Weekly dosing cohorts (Part A: Sym004 6 mg/kg, Part A: Sym004 9/6 mg/kg, Part A: Sym004 12 mg/kg, Part B: Sym004 12 mg/kg) were not applicable for Week 5 assessment. Biweekly dosing cohort (Part A: Sym004 18 mg/kg) was only applicable for Week 5 assessment.|Pre-infusion, end of infusion, 4, 8, 12, 24 hours post-infusion at Week 5|The PK Analysis Set consisted of all subjects who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004.||μg/mL||Geometric Coefficient of Variation|Geometric Mean
655104|NCT01955473|Secondary|Maximum Serum Concentration (Cmax) of Sym004 for the Weekly Regimen at Week 4: Multiple Dose|Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Cmax are presented for both monoclonal antibodies. Weekly dosing cohorts (Part A: Sym004 6 mg/kg, Part A: Sym004 9/6 mg/kg, Part A: Sym004 12 mg/kg, Part B: Sym004 12 mg/kg) were only applicable for Week 4 assessment. Biweekly dosing cohort (Part A: Sym004 18 mg/kg) was not applicable for Week 4 assessment.|Pre-infusion, end of infusion, 4, 8, 12, 24 hours post-infusion at Week 4|"The PK Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here Number of Participants Analyzed signifies those subjects who were evaluable for this outcome measure."||μg/mL||Geometric Coefficient of Variation|Geometric Mean
655105|NCT01955473|Secondary|Maximum Serum Concentration (Cmax) of Sym004 at Week 1: Single Dose|Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Cmax are presented for both monoclonal antibodies.|Pre-infusion, end of infusion, 4, 8, 12, 24, 48 hours post-infusion at Week 1|"The PK Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here Number of Participants Analyzed signifies those subjects who were evaluable for this outcome measure."||microgram per milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
655277|NCT01952834|Primary|Brachial Artery Flow Mediated Dilation|A measurement of endothelial function in humans that reports the percent change in brachial artery diameter to a flow stimulus in the arm induced by 5 minutes of occlusion of flow to the arm. It is measured as the percent change from baseline diameter.|% Change before and after 6 weeks of daily Probiotic|||percent change||Standard Deviation|Mean
655106|NCT01955473|Secondary|Volume of Distribution at Steady State (Vss) of Sym004 for the Biweekly Regimen at Week 5: Multiple Dose|Volume of distribution was defined as the theoretical volume in which the total amount of drug needed to be uniformly distributed to produce the desired serum concentration of a drug. Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Vss are presented for both monoclonal antibodies. Weekly dosing cohorts (Part A: Sym004 6 mg/kg, Part A: Sym004 9/6 mg/kg, Part A: Sym004 12 mg/kg, Part B: Sym004 12 mg/kg) were not applicable for Week 5 assessment. Biweekly dosing cohort (Part A: Sym004 18 mg/kg) was only applicable for Week 5 assessment.|Pre-infusion, end of infusion, 4, 8, 12, 24 hours post-infusion at Week 5|"The PK Analysis Set consisted of all subjects who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here Number of Participants Analyzed signifies those subjects who were evaluable for this outcome measure."||Liter||Geometric Coefficient of Variation|Geometric Mean
655107|NCT01955473|Secondary|Volume of Distribution at Steady State (Vss) of Sym004 for the Weekly Regimen at Week 4: Multiple Dose|Volume of distribution was defined as the theoretical volume in which the total amount of drug needed to be uniformly distributed to produce the desired serum concentration of a drug. Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Vss are presented for both monoclonal antibodies. Weekly dosing cohorts (Part A: Sym004 6 mg/kg, Part A: Sym004 9/6 mg/kg, Part A: Sym004 12 mg/kg, Part B: Sym004 12 mg/kg) were only applicable for Week 4 assessment. Biweekly dosing cohort (Part A: Sym004 18 mg/kg) was not applicable for Week 4 assessment.|Pre-infusion, end of infusion, 4, 8, 12, 24 hours post-infusion at Week 4|"The PK Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here Number of Participants Analyzed =subjects who were evaluable for this outcome and n =subjects who were evaluable for specified monoclonal antibody."||Liter||Geometric Coefficient of Variation|Geometric Mean
655108|NCT01955473|Secondary|Volume of Distribution at the Elimination Phase (Vz) of Sym004 at Week 1: Single Dose|Volume of distribution was defined as the theoretical volume in which the total amount of drug needed to be uniformly distributed to produce the desired serum concentration of a drug. Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Vz are presented for both monoclonal antibodies.|Pre-infusion, end of infusion, 4, 8, 12, 24, 48 hours post-infusion at Week 1|"The PK Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here Number of Participants Analyzed =subjects who were evaluable for this outcome and n =subjects who were evaluable for specified monoclonal antibody."||Liter||Geometric Coefficient of Variation|Geometric Mean
655109|NCT01955473|Secondary|Clearance at Steady-state (CLss) of Sym004 for the Biweekly Regimen at Week 5: Multiple Dose|Clearance at steady state was reported. Clearance of a drug was a measure of the rate at which a drug was metabolized or eliminated by normal biological processes. Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). CLss are presented for both monoclonal antibodies. Weekly dosing cohorts (Part A: Sym004 6 mg/kg, Part A: Sym004 9/6 mg/kg, Part A: Sym004 12 mg/kg, Part B: Sym004 12 mg/kg) were not applicable for Week 5 assessment. Biweekly dosing cohort (Part A: Sym004 18 mg/kg) was only applicable for Week 5 assessment.|Pre-infusion, end of infusion, 4, 8, 12, 24 hours post-infusion at Week 5|"The PK Analysis Set consisted of all subjects who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here Number of Participants Analyzed signifies those subjects who were evaluable for this outcome measure."||Liter/hour||Geometric Coefficient of Variation|Geometric Mean
655110|NCT01955473|Secondary|Clearance at Steady-state (CLss) of Sym004 for the Weekly Regimen at Week 4: Multiple Dose|Clearance at steady state was reported. Clearance of a drug was a measure of the rate at which a drug was metabolized or eliminated by normal biological processes. Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). CLss are presented for both monoclonal antibodies. Weekly dosing cohorts (Part A: Sym004 6 mg/kg, Part A: Sym004 9/6 mg/kg, Part A: Sym004 12 mg/kg, Part B: Sym004 12 mg/kg) were only applicable for Week 4 assessment. Biweekly dosing cohort (Part A: Sym004 18 mg/kg) was not applicable for Week 4 assessment.|Pre-infusion, end of infusion, 4, 8, 12, 24 hours post-infusion at Week 4|"The PK Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here Number of Participants Analyzed =subjects who were evaluable for this outcome and n =subjects who were evaluable for specified monoclonal antibody."||Liter/hour||Geometric Coefficient of Variation|Geometric Mean
655111|NCT01955473|Secondary|Clearance (CL) of Sym004 at Week 1: Single Dose|Clearance of a drug was a measure of the rate at which a drug was metabolized or eliminated by normal biological processes. Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). CL are presented for both monoclonal antibodies.|Pre-infusion, end of infusion, 4, 8, 12, 24, 48 hours post-infusion at Week 1|"The PK Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here Number of Participants Analyzed =subjects who were evaluable for this outcome and n =subjects who were evaluable for specified monoclonal antibody."||Liter/hour||Geometric Coefficient of Variation|Geometric Mean
655119|NCT01955473|Secondary|Area Under Concentration-time Curve (AUC) From Start of First Infusion to Infinity (AUC0-inf) For the Biweekly Regimen at Week 1: Single Dose|Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Here AUC are presented for both monoclonal antibodies. Results were to be assessed for biweekly dosing cohort (Part A: Sym004 18 mg/kg) only.|Pre-infusion, end of infusion, 4, 8, 12, 24, and 48 hours post-infusion at Week 1|The PK Analysis Set consisted of all subjects who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004.||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
655112|NCT01955473|Secondary|Terminal Half-life (t1/2) of Sym004 For the Biweekly Regimen at Week 5: Multiple Dose|Terminal half-life was defined as the time required for the serum concentration of drug to decrease 50 percent in the final stage of its elimination. Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Terminal t1/2 are presented for both monoclonal antibodies. Weekly dosing cohorts (Part A: Sym004 6 mg/kg, Part A: Sym004 9/6 mg/kg, Part A: Sym004 12 mg/kg, Part B: Sym004 12 mg/kg) were not applicable for Week 5 assessment. Biweekly dosing cohort (Part A: Sym004 18 mg/kg) was only applicable for Week 5 assessment.|Pre-infusion, end of infusion, 4, 8, 12, 24 hours post-infusion at Week 5|"The PK Analysis Set consisted of all subjects who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here Number of Participants Analyzed signifies those subjects who were evaluable for this outcome measure."||hours||Geometric Coefficient of Variation|Geometric Mean
655113|NCT01955473|Secondary|Terminal Half-life (t1/2) of Sym004 for the Weekly Regimen at Week 4: Multiple Dose|Terminal half-life was defined as the time required for the serum concentration of drug to decrease 50 percent in the final stage of its elimination. Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Terminal t1/2 are presented for both monoclonal antibodies. Weekly dosing cohorts (Part A: Sym004 6 mg/kg, Part A: Sym004 9/6 mg/kg, Part A: Sym004 12 mg/kg, Part B: Sym004 12 mg/kg) were only applicable for Week 4 assessment. Biweekly dosing cohort (Part A: Sym004 18 mg/kg) was not applicable for Week 4 assessment.|Pre-infusion, end of infusion, 4, 8, 12, 24 hours post-infusion at Week 4|"The PK Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here Number of Participants Analyzed =subjects who were evaluable for this outcome and n =subjects who were evaluable for specified monoclonal antibody."||hours||Geometric Coefficient of Variation|Geometric Mean
655114|NCT01955473|Secondary|Terminal Half-life (t1/2) of Sym004 at Week 1: Single Dose|Terminal half-life was defined as the time required for the serum concentration of drug to decrease 50 percent in the final stage of its elimination. Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Terminal t1/2 are presented for both monoclonal antibodies.|Pre-infusion, end of infusion, 4, 8, 12, 24, 48 hours post-infusion at Week 1|"The PK Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here Number of Participants Analyzed =subjects who were evaluable for this outcome and n =subjects who were evaluable for specified monoclonal antibody."||hours||Geometric Coefficient of Variation|Geometric Mean
655115|NCT01955473|Secondary|Dose Normalized Area Under Concentration-time Curve (AUC) From Start of First Infusion to Infinity (AUC0-inf) For the Biweekly Regimen at Week 5: Multiple Dose|Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Here dose normalized AUC are presented for both monoclonal antibodies. Weekly dosing cohorts (Part A: Sym004 6 mg/kg, Part A: Sym004 9/6 mg/kg, Part A: Sym004 12 mg/kg, Part B: Sym004 12 mg/kg) were not applicable for Week 5 assessment. Biweekly dosing cohort (Part A: Sym004 18 mg/kg) was only applicable for Week 5 assessment. Dose normalized AUC for AUC0-inf was calculated as AUC(0-inf)/Dose.|Pre-infusion, end of infusion, 4, 8, 12, 24 hours post-infusion at Week 5|"The PK Analysis Set consisted of all subjects who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here Number of Participants Analyzed signifies those subjects who were evaluable for this outcome measure."||μg*h/mL/mg||Geometric Coefficient of Variation|Geometric Mean
655116|NCT01955473|Secondary|Dose Normalized Area Under Concentration-time Curve (AUC) From Start of First Infusion to Infinity (AUC0-inf) for the Weekly Regimen at Week 4: Multiple Dose|Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Here dose normalized AUC are presented for both monoclonal antibodies. Weekly dosing cohorts (Part A: Sym004 6 mg/kg, Part A: Sym004 9/6 mg/kg, Part A: Sym004 12 mg/kg, Part B: Sym004 12 mg/kg) were only applicable for Week 4 assessment. Biweekly dosing cohort (Part A: Sym004 18 mg/kg) was not applicable for Week 4 assessment. Dose normalized AUC for AUC0-inf was calculated as AUC(0-inf)/Dose.|Pre-infusion, end of infusion, 4, 8, 12, 24 hours post-infusion at Week 4|"The PK Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here Number of Participants Analyzed =subjects who were evaluable for this outcome and n =subjects who were evaluable for specified monoclonal antibody."||μg*h/mL/mg||Geometric Coefficient of Variation|Geometric Mean
655117|NCT01955473|Secondary|Dose Normalized Area Under Concentration-time Curve (AUC) From Start of First Infusion to Infinity (AUC0-inf) at Week 1: Single Dose|Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Here dose normalized AUC are presented for both monoclonal antibodies. Dose normalized AUC for AUC0-inf was calculated as AUC(0-inf)/Dose.|Pre-infusion, end of infusion, 4, 8, 12, 24, and 48 hours post-infusion at Week 1|"The PK Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here Number of Participants Analyzed =subjects who were evaluable for this outcome and n =subjects who were evaluable for specified monoclonal antibody."||μg*h/mL/mg||Geometric Coefficient of Variation|Geometric Mean
655118|NCT01955473|Secondary|Area Under Concentration-time Curve (AUC) From Start of First Infusion to Infinity (AUC0-inf) For the Biweekly Regimen at Week 5: Multiple Dose|Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Here AUC are presented for both monoclonal antibodies. Results were to be assessed for biweekly dosing cohort (Part A: Sym004 18 mg/kg) only.|Pre-infusion, end of infusion, 4, 8, 12 and 24 hours post-infusion at Week 5|"The PK Analysis Set consisted of all subjects who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here, Number of Participants Analyzed signifies those subjects who were evaluable for this outcome measure."||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
655120|NCT01955473|Secondary|Dose Normalized Area Under Concentration-time Curve (AUC) From Start of First Infusion to 336 Hours (AUC0-336hours) For the Biweekly Regimen at Week 5: Multiple Dose|Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Here dose normalized AUC are presented for both monoclonal antibodies. Results were to be assessed for biweekly dosing cohort (Part A: Sym004 18 mg/kg) only. Dose normalized AUC for AUC0-336 was calculated as AUC(0-336)/Dose.|Pre-infusion, end of infusion, 4, 8, 12, 24, 168 and 336 hours post-infusion at Week 5|"The PK Analysis Set consisted of all subjects who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here, Number of Participants Analyzed signifies those subjects who were evaluable for this outcome measure."||μg*h/mL/mg||Geometric Coefficient of Variation|Geometric Mean
655121|NCT01955473|Secondary|Dose Normalized Area Under Concentration-time Curve (AUC) From Start of First Infusion to 336 Hours (AUC0-336hours) For the Biweekly Regimen at Week 1: Single Dose|Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Here dose normalized AUC are presented for both monoclonal antibodies. Results were to be assessed for biweekly dosing cohort (Part A: Sym004 18 mg/kg) only. Dose normalized AUC for AUC0-336 was calculated as AUC(0-336)/Dose.|Pre-infusion, end of infusion, 4, 8, 12, 24, 48, 168, 336 hours post-infusion at Week 1|The PK Analysis Set consisted of all subjects who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004.||μg*h/mL/mg||Geometric Coefficient of Variation|Geometric Mean
655122|NCT01955473|Secondary|Area Under Concentration-time Curve (AUC) From Start of First Infusion to 336 Hours (AUC0-336hours) For the Biweekly Regimen at Week 5: Multiple Dose|Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Here AUC are presented for both monoclonal antibodies. Results were to be assessed for biweekly dosing cohort (Part A: Sym004 18 mg/kg) only.|Pre-infusion, end of infusion, 4, 8, 12, 24, 168 and 336 hours post-infusion at Week 5|"The PK Analysis Set consisted of all subjects who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here, Number of Participants Analyzed signifies those subjects who were evaluable for this outcome measure."||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
655123|NCT01955473|Secondary|Area Under Concentration-time Curve (AUC) From Start of First Infusion to 336 Hours (AUC0-336hours) For the Biweekly Regimen at Week 1: Single Dose|Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Here AUC are presented for both monoclonal antibodies. Results were to be assessed for biweekly dosing cohort (Part A: Sym004 18 mg/kg) only.|Pre-infusion, end of infusion, 4, 8, 12, 24, 48, 168, 336 hours post-infusion at Week 1|The PK Analysis Set consisted of all subjects who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004.||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
655124|NCT01955473|Secondary|Dose Nornamized Area Under Concentration-time Curve (AUC) From Start of First Infusion to 168 Hours (AUC0-168h) for the Weekly Regimen at Week 4: Multiple Dose|Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Here dose normalized AUC are presented for both monoclonal antibodies. Dose normalized AUC for AUC0-168 was calculated as AUC(0-168)/Dose. Results were to be assessed for weekly dosing cohorts (Part A: Sym004 6 mg/kg, Part A: Sym004 9/6 mg/kg, Part A: Sym004 12 mg/kg, Part B: Sym004 12 mg/kg) only.|Pre-infusion, end of infusion, 4, 8, 12, 24, and 168 hours post-infusion at Week 4|"The PK Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here Number of Participants Analyzed =subjects who were evaluable for this outcome and n =subjects who were evaluable for specified monoclonal antibody."||μg*h/mL/mg||Geometric Coefficient of Variation|Geometric Mean
655125|NCT01955473|Secondary|Dose Normalized Area Under Concentration-time Curve (AUC) From Start of First Infusion to 168 Hours (AUC0-168h) at Week 1: Single Dose|Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Here dose normalized AUC are presented for both monoclonal antibodies. Dose normalized AUC for AUC0-168 was calculated as AUC(0-168)/Dose.|Pre-infusion, end of infusion, 4, 8, 12, 24, 48 and 168 hours post-infusion at Week 1|"The Pharmacokinetics (PK) Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here Number of Participants Analyzed signifies those subjects who were evaluable for this outcome measure."||μg*h/mL/mg||Geometric Coefficient of Variation|Geometric Mean
655126|NCT01955473|Secondary|Area Under Concentration-time Curve (AUC) From Start of First Infusion to 168 Hours (AUC0-168h) for the Weekly Regimen at Week 4: Multiple Dose|Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Here AUC are presented for both monoclonal antibodies. Results were to be assessed for weekly dosing cohorts (Part A: Sym004 6 mg/kg, Part A: Sym004 9/6 mg/kg, Part A: Sym004 12 mg/kg, Part B: Sym004 12 mg/kg) only.|Pre-infusion, end of infusion, 4, 8, 12, 24, and 168 hours post-infusion at Week 4|The PK Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here “Number of Participants Analyzed” =subjects who were evaluable for this outcome and “n” =subjects who were evaluable for specified monoclonal antibody.||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
655127|NCT01955473|Secondary|Area Under Concentration-time Curve (AUC) From Start of First Infusion to 168 Hours (AUC0-168h) at Week 1: Single Dose|Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Here AUC are presented for both monoclonal antibodies.|Pre-infusion, end of infusion, 4, 8, 12, 24, 48 and 168 hours post-infusion at Week 1|The Pharmacokinetics (PK) Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure.||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
655128|NCT01955473|Primary|Number of Subjects With Treatment-emergent Adverse (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation or TEAEs Leading to Death|An adverse event (AE) was defined as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. AEs were considered treatment emergent if they started on or after the day of first administration of the Sym004 or if they started prior to administration but worsened after receiving the first dose of treatment.|Baseline up to 4 weeks after the last Sym004 administration, up to a maximum of 41.1 weeks|Safety analysis set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004.||subjects|||Number
655129|NCT01955473|Primary|Number of Subjects With Dose Limiting Toxicities (DLTs) Determined in Part-A|DLT: any of the following National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE) Grade 4 hematologic or Grade 3/4 non-hematologic toxicities that occurred during DLT observation period of Part A, and were considered by Investigator to be at least possibly related to study treatment, and confirmed by Safety Monitoring Committee. Hematological toxicities: Grade 4 neutropenia, febrile neutropenia, Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with bleeding episodes. Nonhematological toxicities: Grade 3 or higher non-hematological toxicity with exception of Grade 3 fatigue/skin toxicity; Grade 3 nausea/vomiting without appropriate prophylactic therapy; Grade 3 diarrhoea recovered within 2 days with adequate treatment or did not accompany fever/dehydration; Grade 3 or 4 laboratory liver parameter abnormalities with duration of less than 3 days.|Week 1 up to Week 4 (Part A)|DLT Analysis Set consisted of all subjects who received at least 3 of 4 weekly administrations (for weekly dosing cohort) or who received 2 biweekly administrations (for biweekly dosing cohort) and experienced a DLT during DLT observation period.||subjects|||Number
655130|NCT01955369|Other Pre-specified|Gastrostomy|gastrostomy of ALS patients following weight loss and/or swallowing problems with aspiration|an average of 3 years|||participants|||Number
655131|NCT01955369|Secondary|Tracheostomy|tracheostomy in ALS patients following respiratory failure|an average of 3 years|||participants|||Number
655132|NCT01955369|Primary|Death|death of participating ALS patients independent of the cause of death|an average of 3 years|||participants|||Number
655133|NCT01955161|Secondary|Change in Health-related Quality of Life (EQ-5D VAS)|"Change from baseline to Week 24 in EQ-5D Visual Analogue Scale (EQ-5D VAS).
The EQ-5D is a patient-reported assessment that measures the patient's well-being. It consists of an utility score based on 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a Visual Analogue Scale (VAS). The VAS ranges from 0 (worst imaginable health state) to 100 (best imaginable health state)."|Baseline to Week 24|All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least on valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.||units on a scale||Standard Error|Least Squares Mean
655134|NCT01955161|Secondary|Change in Health-related Quality of Life (EQ-5D) Utility Score|"Change from baseline to Week 24 in EuroQol 5-dimensional (EQ-5D) utility score
The EQ-5D is a patient-reported assessment that measures the patient's well-being. It consists of an utility score based on 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a Visual Analogue Scale (VAS). Each descriptive item is rated on a 3-point index ranging from 1 (no problems) to 3 (extreme problems) that is used for calculating a single summary index (from 0 to 1). A higher EQ-5D score indicates a worse outcome."|Baseline to Week 24|All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least on valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.||units on a scale||Standard Error|Least Squares Mean
655135|NCT01955161|Secondary|Change in Cognitive Aspects of Mental Function|Change from baseline to Week 24 in Mini Mental State Examination (MMSE). The Mini Mental State Examination (MMSE) is an 11-item test to assess the cognitive aspects of mental function. The subtests assess orientation, memory, attention, language, and visual construction. The scores for each item is dichotomous (1 = response is correct, 0 = response is incorrect). Total score of the 11 items ranges from 0 to 30 (higher score indicates lower deficit).|Baseline to Week 24|All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least on valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.||units on a scale||Standard Error|Least Squares Mean
655136|NCT01955161|Secondary|Clinical Worsening|Clinical worsening at Week 24 (Based on pre-specified ADAS-cog, ADCS-ADL23, and ADCS-CGIC changes [change in ADAS-cog above or equal to 4, change in ADCS-ADL23 below 0, and ADCS-CGIC above 4])|Week 24|All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least on valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.||Participants|||Count of Participants
655137|NCT01955161|Secondary|Clinical Improvement|Clinical response at Week 24 (based on pre-specified ADAS-cog, ADCS-ADL23, and ADCS-CGIC changes [change in ADAS-cog below or equal to -4, change in ADCS-ADL23 at least 0, and ADCS-CGIC below or equal to 4])|Week 24|All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least on valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.||Participants|||Count of Participants
655147|NCT01955122|Secondary|Sedation|Sedation dosage|During the procedure|Sedation dosage was not collected from any participant during the study|||||
655278|NCT01952691|Secondary|Adduction Angle|we aimed to see the change in hallux valgus angle during treatment.|baseline and 30th days.|||degrees|Participants|Standard Deviation|Mean
655138|NCT01955161|Secondary|Change in NPI Anxiety Item Score in Patients With an NPI Anxiety Item Score of at Least 2 at Baseline|"Change from baseline to Week 24 in NPI anxiety item score in patients with an NPI anxiety item score of at least 2 at baseline
The Neuropsychiatric Inventory is a 12-item structured interview with a caregiver to assess behavioural disturbances. The NPI comprises 10 behavioural and 2 neurovegetative items. Each item consists of a screening question and several sub-questions that are rated no (not present) or yes (present). Each item is then rated for frequency (a 4-point scale from 1 [occasionally] to 4 [very frequent]) and severity (a 3-point scale from 1 [mild] to 3 [marked]). The total score for the NPI anxiety item ranges from 0-12 (frequency multiplied by severity), where a higher score represents a worse outcome."|Baseline to Week 24|All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least on valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome/item measure assessed||units on a scale||Standard Error|Least Squares Mean
655139|NCT01955161|Secondary|Change in Individual Behavioural Disturbance Items|"Change in single NPI item scores at Week 24.
The Neuropsychiatric Inventory is a 12-item structured interview with a caregiver to assess behavioural disturbances. The NPI comprises 10 behavioural and 2 neurovegetative items. Each item consists of a screening question and several sub-questions that are rated no (not present) or yes (present). Each item is then rated for frequency (a 4-point scale from 1 [occasionally] to 4 [very frequent]) and severity (a 3-point scale from 1 [mild] to 3 [marked]). Total score for each single NPI item ranges from 0-12 (frequency multiplied by severity), where higher scores represent worse outcome."|Baseline to Week 24|All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least on valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure/item assessed||units on a scale||Standard Error|Least Squares Mean
655140|NCT01955161|Secondary|Change in Behavioural Disturbance|"Change from baseline to Week 24 in Neuropsychiatric Inventory (NPI) total score.
The Neuropsychiatric Inventory is a 12-item structured interview with a caregiver to assess behavioural disturbances. The NPI comprises 10 behavioural and 2 neurovegetative items. Each item consists of a screening question and several sub-questions that are rated no (not present) or yes (present). Each item is rated for frequency (a 4-point scale from 1 [occasionally] to 4 [very frequent]) and severity (a 3-point scale from 1 [mild] to 3 [marked]). The total NPI score is the frequency ratings multiplied by the severity ratings and ranges from 0 to 144 (higher score indicates worse outcome)."|Baseline to Week 24|All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least on valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.||units on a scale||Standard Error|Least Squares Mean
655141|NCT01955161|Secondary|Change in Global Impression|"Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) score at Week 24.
The Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change is a semi-structured interview to assess clinically relevant changes in patients with AD. The items determine cognition, behavior, social and daily functioning. Severity at baseline is rated on a 7-point scale from 1 (normal, not ill at all) to 7 (among the most extremely ill patients). The clinically relevant change from baseline is rated on a 7-point scale from 1 (marked improvement) to 7 (marked worsening)."|Baseline to Week 24|All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least on valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.||units on a scale||Standard Error|Least Squares Mean
655142|NCT01955161|Secondary|Change in Daily Functioning|"Change from baseline to Week 24 in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL23) total score.
The Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL23) is a 23-item clinician-rated inventory to assess activities of daily living (conducted with a caregiver or informant). Each item comprises a series of hierarchical sub-questions, ranging from the highest level of independent performance to a complete loss for each activity. Total score of the 23 items ranges from 0 to 78 (higher score indicates lower disability)."|Baseline to Week 24|All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least on valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.||units on a scale||Standard Error|Least Squares Mean
655143|NCT01955161|Primary|Change in Cognition|"Change from baseline to Week 24 in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) total score.
The Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-cog) is a 11-item neuropsychological test that assess the severity of cognitive impairment. The items determine the patient's orientation, memory, language, and praxis. Total score of the 11 items range from 0 to 70 (lower score indicates lower cognitive impairment)."|Baseline to Week 24|All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least on valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.||units on a scale||Standard Error|Least Squares Mean
655144|NCT01955122|Secondary|Patient Satisfaction|"Follow up phone call was done 24 hours post procedure. Patients were asked the following : On a 0 to 10 scale, with “0” being no pain and “10” being pain as bad as you can imagine, how would you describe your colonoscopy experience? 0 1 2 3 4 5 6 7 8 9 10"|24 hours post procedure|Data was not analyzed since the patients satisfactory score was general estimation which could not be associated with either the standard colonoscopy or the EndoRings colonoscopy, therefore the intended endpoint failed.|||||
655145|NCT01955122|Secondary|Colon Area Screened|Subjective evaluation of the additional area screened by the physician.|During the procedure|Evaluation of the additional area screened by the physician was not collected from any participant during the study|||||
655146|NCT01955122|Secondary|Scope Centering Ability|Ability to center the scope inside the gastrointestinal tract.|During the procedure|Centering ability was not collected from any procedure during the study|||||
655148|NCT01955122|Secondary|Procedure Time A Stopwatch Will be Used for Stopping the Timing of the Procedure for Any Polypectomy Performed and Then Restarting Once the Polypectomy is Completed, Meaning That Purely Procedure Time is Measured|The following will be recorded: a. Time for intubation to the cecum. b. Time for withdrawal from the cecum to the anal verge. c. Total procedure time A stopwatch will be used for stopping the timing of the procedure for any polypectomy performed and then restarting once the polypectomy is completed, meaning that purely procedure time is measured|During the procedure|||minutes||Standard Deviation|Mean
655149|NCT01955122|Secondary|Total Number of Therapeutic Interventions Performed|Ability to perform therapeutic interventions, such as biopsies, polypectomies, APC etc. during the Standard Colonoscopy and during the EndoRings Colonoscopy. The number of interventions was not compared, this was just a safety outcome meant to prove there was no difficulty in performing interventions in both arms.|Interventions during procedure|||Total Interventions performed|||Number
655150|NCT01955122|Primary|Adenoma and Polyp Miss Rate|"Group A- we measured the Adenoma&Polyp miss rates in the first procedure with Standard (based on what we discovered on the second procedure with the EndoRings).
Group B- we measured the Adenoma&Polyp miss rates in the first procedure with EndoRings (based on what we discovered on the second procedure with the Standard).
Adenoma/Polyp Miss Rate means: total number of adenomas or polyps detected during the second procedure per Group divided by the total number of adenomas/polyps detected overall per Group]*100"|30min for Standard colonoscopy and 30min for EndoRings colonoscopy- 1 hour in total.|||percentage of :Adenomas/Polyp missed||95% Confidence Interval|Number
655151|NCT01955083|Post-Hoc|Percentage of Good Response After MIS|Postoperative ‘VAS <=3’ was traditionally defined as ‘major response’. For a comprehensive profile of the outcomes, we further created another definition of ‘fine response’: ‘postoperative VAS <=5 plus SOS >=60’ post hoc in the present study. Accordingly, patients with a postoperative VAS <=3 or postoperative VAS <=5 plus SOS >=60' group was considered to have a 'good response'. Therefore, we calculated the 'good response' rate in the radiofrequency and pillar implant groups.|baseline and 3 months following surgery|A total of 28 participants completed the follow-up protocol and two participants dropped out after surgery.||percentage of Good Response||Standard Error|Mean
655152|NCT01955083|Secondary|Percent Change in B1-Fmean After MIS|Percent change ([after value-before value]/[before value]*100) in B1-Fmean (Hz) before and at 3 months after surgery was calculated.|baseline and 3 months following surgery|A total of 28 participants completed the follow-up protocol and two participants dropped out after surgery.||percentage of B1-Fmean||Standard Error|Mean
655153|NCT01955083|Secondary|Percent Change in B1-Fpeak After MIS|Percent change ([after value-before value]/[before value]*100) in B1-Fpeak (Hz) before and at 3 months after surgery was calculated.|baseline and 3 months following surgery|A total of 28 participants completed the follow-up protocol and two participants dropped out after surgery.||percentage of B1-Fpeak||Standard Error|Mean
655154|NCT01955083|Secondary|Percent Change in B1-Imean After MIS|Percent change ([after value-before value]/[before value]*100) in B1-Imean (dB) before and at 3 months after surgery was calculated.|baseline and 3 months following surgery|A total of 28 participants completed the follow-up protocol and two participants dropped out after surgery.||percentage of B1-Imean||Standard Error|Mean
655155|NCT01955083|Secondary|Percent Change in B1-Imax After MIS|Percent change ([after value-before value]/[before value]*100) in B1-Imax (dB) before and at 3 months after surgery was calculated.|baseline and 3 months following surgery|A total of 28 participants completed the follow-up protocol and two participants dropped out after surgery.||percentage of B1-Imax||Standard Error|Mean
655156|NCT01955083|Secondary|Percent Change in B1-SI After MIS|Percent change ([after value-before value]/[before value]*100) in B1-SI (event/hour) before and at 3 months after surgery was calculated.|baseline and 3 months following surgery|A total of 28 participants completed the follow-up protocol and two participants dropped out after surgery.||percentage of B1-SI||Standard Error|Mean
655157|NCT01955083|Secondary|Percent Change in Total-Fmean After MIS|Percent change ([after value-before value]/[before value]*100) in Total-Fmean (Hz) before and at 3 months after surgery was calculated.|baseline and 3 months following surgery|A total of 28 participants completed the follow-up protocol and two participants dropped out after surgery.||percentage of Total-Fmean||Standard Error|Mean
655158|NCT01955083|Secondary|Percent Change in Total-Fpeak After MIS|Percent change ([after value-before value]/[before value]*100) in Total-Fpeak (Hz) before and at 3 months after surgery was calculated.|baseline and 3 months following surgery|A total of 28 participants completed the follow-up protocol and two participants dropped out after surgery.||percentage of Total-Fpeak||Standard Error|Mean
655159|NCT01955083|Secondary|Percent Change in Total-Imean After MIS|Percent change ([after value-before value]/[before value]*100) in Total-Imean (dB) before and at 3 months after surgery was calculated.|baseline and 3 months following surgery|A total of 28 participants completed the follow-up protocol and two participants dropped out after surgery.||percentage of Total-Imean||Standard Error|Mean
655160|NCT01955083|Secondary|Percent Change in Total-Imax After MIS|Percent change ([after value-before value]/[before value]*100) in Total-Imax (dB) before and at 3 months after surgery was calculated.|baseline and 3 months following surgery|A total of 28 participants completed the follow-up protocol and two participants dropped out after surgery.||percentage of Total-Imax||Standard Error|Mean
655161|NCT01955083|Secondary|Percent Change in Total-SI After MIS|Percent change ([after value-before value]/[before value]*100) in Total-SI (event/hour) before and at 3 months after surgery was calculated.|baseline and 3 months following surgery|A total of 28 participants completed the follow-up protocol and two participants dropped out after surgery.||percentage of Total-SI||Standard Error|Mean
655162|NCT01955083|Secondary|Change in SOS Score After MIS|Change in SOS score at 3 months after radiofrequency or pillar implant were calculated.|baseline and 3 months following surgery|Twenty-eight participants completed the follow-up protocol and two participants dropped out after surgery.||units on a scale||95% Confidence Interval|Mean
655163|NCT01955083|Primary|Change in VAS Score After MIS|The mean change in subjective snoring severity (VAS) at 3 months after MIS was the primary outcome measurement.|baseline and 3 months following surgery|Twenty-eight patients completed the protocol; two study cases were not available for follow-up. Fourteen patients underwent radiofrequency surgery and 14 patients received pillar implant surgery. Accordingly, we analyzed the participants who completed the study protocol.||units on a scale||95% Confidence Interval|Mean
655164|NCT01955044|Secondary|Resolvin Levels|resolvin, a metabolite of LCPUFA, will be measured at 2 weeks of life.|2 weeks of life||02/2018||||
655168|NCT01955005|Secondary|Proportion of Participants Who Received One or More Duplicate Laboratory Tests in the Non-VA Provider Visit.|Therapeutic duplication will be defined as concurrent use of more than one medication from the same therapeutic class. For laboratory duplication, we will review non-VA and VA medical records 6 months prior to the non-VA provider visit. Each patient will be assigned a dichotomous indicator for whether they received therapeutic duplication and/or laboratory duplication during their non-VA provider visit|Typically within 1 month of non-VA provider visit|Some veterans had their laboratories drawn prior to the medical visit and were therefore excluded from this analysis.||proportion of participants|||Number
655169|NCT01955005|Secondary|Proportion of Total Number of Unique Medications Discrepant Between VA and Non-VA Medication Lists|A medication discrepancy metric was be calculated by comparing the current VA medication list with the non-VA provider medication list to determine the total number of distinct medications. The number of discrepant medications between these lists is the numerator and is divided by the total number of distinct medications on both lists combined. This will yield a range of scores between score between 0 and 1, with 1 indicating perfect agreement between the two lists.|Typically within 1 month of non-VA provider visit|Medication reconciliation was based on Medical Record Review, therefore there was better representation of the entire sample. 2 Veterans were not included in the Internet Skills Training group because the medical records sent from the Non-VA provider were not adequate to determine an accurate medication list.||proportion of medications discrepant||Standard Deviation|Mean
655170|NCT01955005|Primary|Percentage of Participants Who Brought Their VA Information From My HealtheVet to Their Visit With Their Non-VA Provider|The primary outcome is whether or not the veteran brings their VA information from My HealtheVet to their visit with their non-VA provider. Providers will be asked to complete a form during the appointment where assessment of sharing this information is embedded in a checklist of possible visit activities. Participants will also if they provided this information to the provider in the event the provider opts to not return the form.|Within 1-2 week of non-VA provider visit|This outcome was collected from the provider completed questionnaire. The reduced sample size is due to the response rate for the My Healthe Vet training group providers (74%) and the Internet Skills Training group (52%).||Percentage of Participants|||Number
655171|NCT01954771|Secondary|HbA1c(%) at Endpoint||12 weeks|13 patients did not followed the study protocol.||percentage||Inter-Quartile Range|Median
655172|NCT01954771|Secondary|Number of Participants With Severe Hypoglycemia (≤50 mg/dL or 2.8mmol/L),Captured by SMBG Method and CGMS|Severe hypoglycemia is defined as glucose concentration of ≤2.8mmol/L (50 mg/dL).|12 weeks|13 patients did not followed the study protocol.||participants|||Number
655173|NCT01954771|Secondary|The Correlation Study Between HbA1c and Glycemic Profiles of MBG (Mean Blood Glucose) From SMBG Protocols and CGMS|A correlation coefficient of 0.5 is defined as large effect size.(Cohen Jacob.Statistical power analysis for the the behavioral sciences.2nd edition.Lawrence Erlbaum Associates.1988:80)|12 weeks|13 patients did not followed the study protocol.||mmol/L||Inter-Quartile Range|Median
655174|NCT01954771|Primary|Evaluation of Peak and Nadir Glucose Profiles From Continuous Glucose Monitoring System (CGMS)|The peak value:＞16.7mmol/L(which may precipitate ketosis),nadir:≤2.8mmol/L(Severe hypoglycemia).|12 weeks|13 patients did not followed the study protocol.||mmol/L||Inter-Quartile Range|Median
655175|NCT01954745|Secondary|Median Overall Survival (OS)|To evaluate the median overall survival (OS) for patients with advanced cholangiocarcinoma receiving cabozantinib|2 years|Patients treated with cabozantinib 60 mg daily administered orally continuously for 28-day cycles||months||95% Confidence Interval|Median
655176|NCT01954745|Secondary|Objective Response Rate (ORR)|To evaluate the objective response rate (ORR) for patients with advanced cholangiocarcinoma receiving cabozantinib|2 Years|Patients treated with cabozantinib 60 mg daily administered orally continuously for 28-day cycles||percent|||Number
655177|NCT01954745|Secondary|Number of Patients With Adverse Events|Evaluate the number of patients with advanced cholangiocarcinoma being treated with cabozantinib who have adverse events during treatment|2 Years|Patients treated with cabozantinib 60 mg daily administered orally continuously for 28-day cycles||participants|||Number
655178|NCT01954745|Primary|Median Progression Free Survival (PFS)|To evaluate the median progression free survival (PFS) of cabozantinib in patients with advanced cholangiocarcinoma after progression on 1 or 2 prior systemic therapies.|2 Years|Patients treated with cabozantinib 60 mg daily administered orally continuously for 28-day cycles||months||95% Confidence Interval|Median
655179|NCT01954628|Secondary|AQX-1125 Concentrations in Plasma (Trough Values)|The secondary objectives are to evaluate the pharmacokinetics (PK) of AQX-1125 in plasma.|12 weeks|PK Population||micrograms per Liter||Geometric Coefficient of Variation|Geometric Mean
655180|NCT01954628|Secondary|Change From Baseline in FEV1|"The secondary objective is to evaluate the treatment effect of once daily administrations of AQX-1125 compared to placebo over 12 weeks on forced expiratory volume in 1 second [FEV1].
FEV1 was determined from post-bronchodilator spirometry testing done at clinic visits."|12 weeks|Full analysis set. Missing post-treatment data imputed using the last observation carried forward principle.||Liter||95% Confidence Interval|Least Squares Mean
655181|NCT01954628|Secondary|The Number of Subjects With at Least One COPD Exacerbation.|The number of subjects that presented with a COPD exacerbation during the 12 week treatment period.|12 weeks|Full analysis set.||participants|||Number
655182|NCT01954628|Secondary|Time to First COPD Exacerbation|The secondary objective is to evaluate the treatment effect of once daily administrations of AQX-1125 compared to placebo over 12 weeks on the time to first exacerbation requiring medical intervention of oral corticosteroids and/or antibiotics.|12 weeks|Full analysis set||day(s)||Standard Deviation|Mean
655183|NCT01954628|Secondary|Analysis of the Number of COPD Exacerbations (Medically Treated Event (MTE))|"The secondary objective is to evaluate the treatment effect of once daily administrations of AQX-1125 compared to placebo over 12 weeks on the number of COPD exacerbations (MTE).
COPD exacerbations were referred to as Medically Treated Exacerbations (MTEs) and identified as a change in symptoms and/or signs of COPD requiring prescription of one or both of: (1) Course of oral corticosteroids or (2) Antibiotic(s)."|12 weeks|Full analysis set was used and analyzed using the negative binomial regression model with fixed factors treatment, region and time in study as offset. Adjusted means for treatment group shows number of exacerbations/year.||Number of exacerbations/year||95% Confidence Interval|Least Squares Mean
657146|NCT01927120|Secondary|Cumulative Incidence of Relapse|Incidence of primary disease relapse per standard definitions.|1 year post HCT|All participants.||percentage of participants||95% Confidence Interval|Number
655184|NCT01954628|Secondary|Change From Baseline in COPD Assessment Tool (CAT) Score|The secondary objective is to evaluate the treatment effect of once daily administrations of AQX-1125 compared to placebo over 12 weeks on the COPD Assessment Tool (CAT) score.The CAT questionnaire measures the impact of COPD on wellbeing and daily life. Participants answer 8 questions on a scale from 0 (best) to 5 (worst). The total score ranges from 0 to 40 with higher scores indicating more impact. A negative change from baseline indicates improvement. The change in total CAT score from Day 1, before taking study drug (baseline), to end of the 12 week treatment period was compared between the two treatments using an ANOVA model adjusting for treatment and region and including the baseline score as a covariate.|12 weeks|Full analysis set. Missing post-treatment data imputed using the last observation carried forward principle.||COPD Assessment Tool Score||95% Confidence Interval|Least Squares Mean
655185|NCT01954628|Primary|The Primary Efficacy Variable Was the AAC for Daily EXACT Scores During the 12-week Treatment Period.|The primary variable (endpoint) of this study is the difference in the Area Above the Curve (AAC) for the daily EXACT score from baseline to Week 12 between subjects treated with AQX-1125 and placebo.The EXACT questionnaire is a patient reported outcome (PRO) measure designed to standardise the method for evaluating the frequency, severity and duration of acute exacerbations of COPD. The EXACT is a 14-item daily questionnaire where each item is assessed on a 5 or 6 point ordinal scale. Participants completed the EXACT questionnaire on a daily basis via an electronic diary from Day 1 (pre-dose) to Day 84 (week 12). Higher scores on the daily EXACT questionnaire indicate a more severe health state. When the post-treatment EXACT scores are lower (i.e. improved symptoms) than baseline EXACT, the AACs are positive.|12 weeks|Full Analysis Set (FAS). The FAS was all randomized subjects who have received at least one dose of the study drug and had at least one efficacy assessment (valid diary entries) post-baseline. Imputation, the mean of the last 5 days, counted backwards from day of last recording, in the treatment period will be used.||Area Above Curve on Daily Exact Score||95% Confidence Interval|Least Squares Mean
655302|NCT01952665|Primary|Overall Sensation of Moistness|Participant rating of overall sensation for moistness (hydration). Collected at 4 weeks wear for both study lens pairs. 5-point Likert Scale; 1=Excellent, 2=Good, 3=Average, 4=Below Average, 5=Poor.|4 weeks|||participants|||Number
655303|NCT01952665|Primary|Eye Whiteness/Redness|Participant rating for Eye Whiteness/Redness. Collected at 4 weeks wear for both study lens pairs. (0-10, 0= Significant Redness, 10= Totally White)|4 weeks|||units on a scale||Standard Deviation|Mean
655230|NCT01954121|Secondary|Time to First Seizure During the Period Covering the Up Titration Period, Stabilization Period, and Evaluation Period From the First Dose of Study Drug|Number of qualifying events is reported because it is the only descriptive measure available from the proportional hazards model, that was applied.|From Randomization (Week 1) up to Evaluation Visit (Week 30)|The Per Protocol Set consisted of all subjects in the Full Analysis Set who entered the Evaluation Period and who did not have any important protocol deviations determined to impact the interpretation of efficacy. Criteria that might impact the assessment of efficacy was determined during a Data Review Meeting before the database lock.||events|||Number
655304|NCT01952665|Primary|Vision Satisfaction|Participant rating for vision satisfaction. Collected at 4 weeks wear for both study lens pairs. (0-10, 0= Very Unsatisfied, 10= Very Satisfied)|4 weeks|||units on a scale||Standard Deviation|Mean
655203|NCT01954160|Secondary|Left Ventricular End Diastolic Volume|Echo: Left Ventricular End Diastolic Volume|13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.|||||
655204|NCT01954160|Secondary|Tissue Doppler Indices|Echo: Tissue Doppler indices|13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.|||||
655205|NCT01954160|Secondary|Heart Rate Variability|Heart rate variability indices by Holter|13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.|||||
655206|NCT01954160|Secondary|New York Heart Association (NYHA) Functional Classification||13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.|||||
655207|NCT01954160|Secondary|Patient Global Assessment||13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.|||||
655208|NCT01954160|Secondary|Kansas City Cardiomyopathy Questionnaire Score||13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.|||||
655209|NCT01954160|Secondary|6 Minute Walk Test||13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.|||||
655210|NCT01954160|Secondary|Plasma Aldosterone||13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.|||||
655211|NCT01954160|Secondary|Plasma Renin Activity||13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.|||||
655212|NCT01954160|Secondary|Resting Urine Norepinephrine||13 Weeks following Renal Denervation||||||
655213|NCT01954160|Secondary|Resting Plasma Norepinephrine||13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.|||||
655214|NCT01954160|Secondary|Plasma N-terminal Pro-brain Natriuretic Peptide||13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.|||||
655215|NCT01954160|Secondary|Left Atrial Size|Echo: Left Atrial size|13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.|||||
655216|NCT01954160|Secondary|LV End Diastolic Dimension (LVEDd)|Echo: LV end diastolic dimension (LVEDd)|13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.|||||
655217|NCT01954160|Secondary|LV End Systolic Dimension (LVESd)|Echo: LV end systolic dimension (LVESd)|13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.|||||
655218|NCT01954160|Secondary|Global Longitudinal Strain|Echo: Global longitudinal strain Study terminated early, endpoints not measured|13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.|||||
655219|NCT01954160|Secondary|Left Ventricular Ejection Fraction|Echo: Left Ventricular Ejection Fraction Study terminated early, endpoints not measured|13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.|||||
655220|NCT01954160|Secondary|Left Ventricular End Systolic Volume|Echo: Left ventricular end systolic volume Study terminated early, endpoints not measured|13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.|||||
655221|NCT01954160|Secondary|Renal Resistive Index|Intra-renal hemodynamics as measured by Renal Resistive Index (RRI) by renal Doppler ultrasonography Study terminated early, endpoints not measured|13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.|||||
655222|NCT01954160|Secondary|Urine Albumin|Urine albumin|13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.|||||
655223|NCT01954160|Secondary|Creatinine Clearance From 24-hour Urine Creatinine|Study terminated early, endpoints not measured|13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.|||||
655224|NCT01954160|Secondary|Blood Urea Nitrogen (BUN) Level|Study terminated early, endpoints not measured|13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.|||||
655231|NCT01954121|Secondary|Time to First Seizure During the Evaluation Period|Number of qualifying events is reported because it is the only descriptive measure available from the proportional hazards model, that was applied.|From first day in the Evaluation Period (Week 4) up to end of the Evaluation Period (Week 30)|The Per Protocol Set consisted of all subjects in the Full Analysis Set who entered the Evaluation Period and who did not have any important protocol deviations determined to impact the interpretation of efficacy. Criteria that might impact the assessment of efficacy was determined during a Data Review Meeting before the database lock.||events|||Number
655232|NCT01954121|Secondary|Time to First Seizure or Discontinuation Due to an Adverse Event (AE) / Lack of Efficacy (LOE) During the Evaluation Period|Number of qualifying events is reported because it is the only descriptive measure available from the proportional hazards model, that was applied.|From first day in the Evaluation Period (Week 4) up to end of the Evaluation Period (Week 30)|The Per Protocol Set consisted of all subjects in the Full Analysis Set who entered the Evaluation Period and who did not have any important protocol deviations determined to impact the interpretation of efficacy. Criteria that might impact the assessment of efficacy was determined during a Data Review Meeting before the database lock.||events|||Number
655233|NCT01954121|Secondary|Proportion of Subjects Retained in the Study for the Duration of the Period Covering the Up Titration Period, Stabilization Period, and Evaluation Period||From Week 1 to Week 30|The Per Protocol Set consisted of all subjects in the Full Analysis Set who entered the Evaluation Period and who did not have any important protocol deviations determined to impact the interpretation of efficacy. Criteria that might impact the assessment of efficacy was determined during a Data Review Meeting before the database lock.||percentage of subjects|||Number
655234|NCT01954121|Primary|Proportion of Subjects Remaining Seizure Free During the 6-months Evaluation Period||6-months Evaluation Period (From Week 4 to Week 30)|The Per Protocol Set consisted of all subjects in the Full Analysis Set who entered the Evaluation Period and who did not have any important protocol deviations determined to impact the interpretation of efficacy. Criteria that might impact the assessment of efficacy was determined during a Data Review Meeting before the database lock.||percentage of subjects|||Number
655235|NCT01953354|Secondary|Percent of Participants With Increase in Concurrent Ulcerative Colitis (UC) Medications or New Rescue Medications Added|New or increase in UC medications is defined as a need for dose-escalation of concurrent medications or need for rescue medications to treat UC through Week 16.|From Day 0 through Week 16|The Safety population included all subjects for whom study treatment was initiated.||percentage of participants|||Number
655236|NCT01953354|Secondary|Percent of Participants With Increase in Diarrhea|An increase in diarrhea is defined as an increase in the Mayo Score’s Stool Frequency score by at least 1 point from baseline at any time during follow-up.|From Day 0 through end of follow-up, up to 36 weeks|The Safety population included all subjects for whom study treatment was initiated.||percentage of participants|||Number
655237|NCT01953354|Secondary|Percent of Participants With Colonoscopic Evidence of Visible Worm|Stool evaluations for ova and parasites confirmed the absence of T. suis. If evidence suggested a presence of T. suis, a colonoscopy would be performed to confirm invasion with a visible worm.|From Day 0 through end of follow-up, up to 36 weeks|The Safety population included all subjects for whom study treatment was initiated.||percentage of participants|||Number
655238|NCT01953354|Secondary|Time to Modified Clinical Response|Number of days to reach a modified clinical response. Modified clinical response is defined as a reduction in the modified Mayo score (i.e., minus the endoscopy component) of at least 2 points from baseline.|From Baseline through the day that modified clinical response is reached. Week 16 is the last visit that the modified Mayo score is assessed.|The Modified Intent-to-Treat (mITT) population included all randomized subjects who received at least one dose of either TSO or placebo. Only mITT subjects who achieved a modified clinical response are included in this analysis.||Days||Full Range|Median
655239|NCT01953354|Secondary|Percent of Participants With a Modified Clinical Response|Modified clinical response is defined as a reduction in the modified Mayo score (i.e., minus the endoscopy component) of at least 2 points from baseline.|From Day 0 through time of first clinical response or end of follow-up, whichever comes first, up to 12 Weeks|The Modified Intent-to-Treat (mITT) population included all randomized subjects who received at least one dose of either TSO or placebo. Only mITT subjects with baseline and at least one post-baseline modified clinical response result are included in this analysis.||percentage of participants|||Number
655240|NCT01953354|Secondary|Percent of Participants With Healed Colonic Mucosa at Week 12|Healed colonic mucosa is defined as a Mayo endoscopy score of 0 or 1.|Week 12|The Modified Intent-to-Treat (mITT) population included all randomized subjects who received at least one dose of either TSO or placebo. Only mITT subjects with a Mayo endoscopy score at Week 12 are included in this analysis.||percentage of participants|||Number
655241|NCT01953354|Secondary|Percent of Participants Who Achieved Remission at Week 12|Remission is defined as a Mayo score of less than or equal to 1 with absence of rectal bleeding and endoscopy score of 0 or 1.|Week 12|The Modified Intent-to-Treat (mITT) population included all randomized subjects who received at least one dose of either TSO or placebo. Only mITT subjects with remission results at Week 12 are included in this analysis.||percentage of participants|||Number
655242|NCT01953354|Primary|Percentage of Participants Who Achieved a Clinical Response at Week 12|Clinical response is defined as a reduction in the Mayo score of at least 3 points and at least a 30% reduction from Baseline, along with either a decrease from Baseline in the rectal bleeding subscore of more than 1 point or a rectal bleeding subscore of 0 or 1.|Week 12|The Modified Intent-to-Treat (mITT) population included all randomized subjects who received at least one dose of either TSO or placebo. Only mITT subjects with clinical response results at Week 12 are included in this analysis.||percentage of participants|||Number
655243|NCT01953328|Secondary|Percent Change From Baseline in VLDL-C at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
655244|NCT01953328|Secondary|Percent Change From Baseline in VLDL-C at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
655245|NCT01953328|Secondary|Percent Change From Baseline in HDL-C at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
655246|NCT01953328|Secondary|Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
655279|NCT01952691|Secondary|FFI|We aimed to see the change in functional status with FFI (Foot function index) scale The FFI is a self-administered index consisting of 23 items divided into 3 sub-scales used to score each question on a scale from 0 (no pain or difficulty) to 10 (worst pain imaginable or so difficult it required help) that best describes the patients' foot over the past week. Patients were instructed to mark a VAS score for each question. The total score was calculated using only the questions answered.|baseline, on the 3rd, 7th, 10th and 30th days during the treatment|||units on a scale|Participants|Standard Deviation|Mean
655280|NCT01952691|Primary|Adduction Angle of Hallux With X RAY|X ray was obtained in non-weight bearing sitting position. It's aimed to see the treatment effects kinesio taping|up to 30 days after the treatment|35 feet's X Ray results were obtained from 22 patients before treatment protocol was performed.||degrees|Participants|Standard Deviation|Mean
655281|NCT01952665|Primary|Lens Preference for Handling|Participant lens preference regarding handling. Collected at study exit. (Forced Choice; Study Pair 1, Study Pair 2, Habitual).|4 weeks|||participants|||Number
655282|NCT01952665|Primary|Lens Preference Comfort, Dryness, Vision and Overall.|Participant lens preference regarding comfort, dryness, vision and overall. Collected at study exit. (Forced Choice; Study Pair 1, Study Pair 2, Habitual).|4 weeks|||participants|||Number
655283|NCT01952665|Primary|Lens Preference|Participant lens preference in regard for comfort, dryness, handling, vision and overall. Collected at 4 weeks. (Forced Choice; Study Pair 1, Study Pair 2).|4 weeks|||participants|||Number
655284|NCT01952665|Secondary|Participant Likelihood of Recommendation of a Study Lens|Participant likelihood of recommending a study lens to friends. Collected at study exit. (1-4; 1=Very Unlikely, 2=Unlikely, 3=Likely, 4=Very Likely).|4 weeks|||participants|||Number
655285|NCT01952665|Secondary|Participant Recommendation of a Study Lens|Participant most likely recommendation of which study lens to friends, family or colleagues. Collected at study exit. (Forced Choice; Study Pair 1, Study Pair 2).|4 weeks|||participants|||Number
655286|NCT01952665|Primary|Overall Satisfaction|Participant rating of satisfaction overall. Collected at 4 weeks wear for both study lens pairs. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied|4 weeks|||participants|||Number
655287|NCT01952665|Secondary|Likelihood to Continue Wearing the Study Lens|Participant likelihood of continuing wear of the study lense. Collected at 4 weeks wear for both study lens pairs. 4-point Likert Scale; 1=Very Likely, 2=Likely, 3=Unlikely, 4=Very Unlikely|4 weeks|||participants|||Number
655288|NCT01952665|Secondary|Likelihood of Switching From Habitual Lens to Study Lens|Participant likelihood of switching from their habitual lens to the study lens. Collected at 4 weeks wear for both study lens pairs. 4-point Likert Scale; 1=very likely, 2=likely, 3=unlikely, 4=very unlikely|4 weeks|||participants|||Number
655289|NCT01952665|Secondary|Overall Fit Acceptance|Assessment of overall lens fit acceptance. Collected at 4 weeks. (0-4, 0=should not be worn, 1=borderline but unacceptable, 2=minimally acceptable, early review, 3=not perfect but OK to dispense, 4=perfect)|4 Weeks|||lenses|lenses||Number
655290|NCT01952665|Secondary|Push Up Test|Assessment of lens tightness. Collected at 4 weeks. Digital push up test. (Continuous Scale 0-100%, 0%=Falls from cornea without lid support, 50%= Optimum, 100%= No movement)|4 Weeks|||units on a scale|lenses|Standard Deviation|Mean
655291|NCT01952665|Secondary|Post Blink Movement|Assessment of post blink movement. Collected at 4 weeks. Assessed immediately after the blink. (Graded 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement)|4 Weeks|||units on a scale|lenses||Number
655292|NCT01952665|Secondary|Corneal Coverage|Assessment of lens corneal coverage. Collected at 4 weeks. (Biomicroscopy; assessed in primary gaze, Normal Coverage or Not Covering)|4 Weeks|||lenses|lenses||Number
655293|NCT01952665|Secondary|Centration|Assessment of lens centration. Collected at 4 weeks wear for both study lens pairs.. Biomicroscopy, by degree and direction in the primary position. (Optimal Centration or Not Optimal)|4 Weeks|||lenses|lenses||Number
655294|NCT01952665|Secondary|Surface Deposition|Assessment of surface deposition by slit lamp. Collected at 4 weeks wear for both study lens pairs. (Grade 0-4 in 1/2 steps; 0=clean, 4=deposited)|4 Weeks|||units on a scale||Standard Deviation|Mean
655295|NCT01952665|Secondary|Surface Wetting|Assessment of surface wetting by slit lamp. Collected at 4 weeks wear for both study lens pairs. 0=Non-wettable surface, 1= > 1 non-wetting area of some magnitude., 2=One non-wetting area of some magnitude, 3=Hazy surface that resolves with a blink. Typical soft lens appearance with long drying time., 4=Smooth uniformly reflective surface. Appearance of a healthy cornea (Grade 0-4 in ½ steps)|4 Weeks|||units on a scale||Standard Deviation|Mean
655296|NCT01952665|Secondary|Binocular Visual Acuity logMAR|Assessment of visual acuity (VA). Collected at 2 weeks for both study lens pairs. Binocular High Contrast Distance. logMAR (negative logMAR values indicates better Visual Acuity (VA)). 0.0 logMAR = 20/20 snellen chart|4 Weeks|||logMAR||Standard Deviation|Mean
655297|NCT01952665|Primary|Overall Vision Satisfaction|Participant rating of overall satisfaction for vision. Collected at 4 weeks wear for both study lens pairs. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied|4 weeks|||participants|||Number
655298|NCT01952665|Primary|Overall Handling Satisfaction|Participant rating of satisfaction regarding handling. Collected at 4 weeks wear for both study lens pairs. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied|4 weeks|||participants|||Number
655299|NCT01952665|Primary|Overall Dryness Satisfaction|Participant rating of satisfaction regarding dryness. Collected at 4 weeks wear for both study lens pairs. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied|4 weeks|||participants|||Number
655300|NCT01952665|Primary|Overall Comfort Satisfaction|Participant rating of satisfaction regarding comfort. Collected at 4 weeks wear for both study lens pairs. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied|4 weeks|||participants|||Number
655301|NCT01952665|Primary|Overall Sensation of Smoothness|Participant rating of overall sensation for smoothness (deposit resistance). Collected at 4 weeks wear for both study lens pairs. 5-point Likert Scale; 1=Excellent, 2=Good, 3=Average, 4=Below Average, 5=Poor.|4 weeks|||participants|||Number
655312|NCT01952665|Secondary|Overall Fit Acceptance|Assessment of overall lens fit acceptance. Collected at 2 weeks for both study pairs. (0-4, 0=should not be worn, 1=borderline but unacceptable, 2=minimally acceptable, early review, 3=not perfect but OK to dispense, 4=perfect)|2 Weeks|||lenses|lenses||Number
655313|NCT01952665|Secondary|Push Up Test|Assessment of lens tightness. Collected at 2 weeks for both study pairs. Digital push up test. (Continuous Scale 0-100%, 0%=Falls from cornea without lid support, 50%= Optimum, 100%= No movement)|2 Weeks|||units on a scale|lenses|Standard Deviation|Mean
655314|NCT01952665|Secondary|Post Blink Movement|Assessment of post blink movement. Collected at 2 weeks for both study lens pairs. Assessed immediately after the blink. (Graded 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement)|2 Weeks|||lenses|lenses||Number
655315|NCT01952665|Secondary|Corneal Coverage|Assessment of lens corneal coverage. Collected at 2 weeks for both study pairs. Biomicroscopy; assessed in primary gaze. (Rated as Normal Coverage or Not Covering)|2 Weeks|||lenses|lenses||Number
655316|NCT01952665|Secondary|Centration|Assessment of lens centration. Collected at 2 weeks. Biomicroscopy; by degree and direction in the primary position. Optimal versus not optimal|2 Weeks|||lenses|lenses||Number
655317|NCT01952665|Secondary|Surface Deposition|Assessment of surface deposition by slit lamp. Collected at 2 weeks for both study lens pairs. (Grade 0-4 in 1/2 steps; 0=clean, 4=deposited)|2 Weeks|||units on a scale|eyes|Standard Deviation|Mean
655318|NCT01952665|Secondary|Surface Wetting|Assessment of surface wetting by slit lamp. Collected at 2 weeks for both study lens pairs. 0=Non-wettable surface, 1= > 1 non-wetting area of some magnitude., 2=One non-wetting area of some magnitude, 3=Hazy surface that resolves with a blink. Typical soft lens appearance with long drying time., 4=Smooth uniformly reflective surface. Appearance of a healthy cornea (Grade 0-4 in ½ steps)|2 Weeks|||units on a scale||Standard Deviation|Mean
655319|NCT01952665|Secondary|Binocular Visual Acuity logMAR|Assessment of visual acuity (VA). Collected at 2 weeks for both study lens pairs. Binocular High Contrast Distance. logMAR (negative logMAR values indicates better Visual Acuity (VA)). 0.0 logMAR = 20/20 snellen chart|2 Weeks|||logMAR||Standard Deviation|Mean
655320|NCT01952665|Primary|Lens Preference, Pair 1 Comfilcon A|Participant preference for habitual lenses or study lenses with regard to comfort, dryness, handling, vision and overall. Collected at 2 weeks for study pair 1. (Randomized to comfilcon A as pair 1; Forced choice: Pair 1 or Habitual)|2 weeks|||participants|||Number
655321|NCT01952665|Primary|Overall Satisfaction|Participant rating of satisfaction overall. After 2 weeks wear for each study pair. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied|2 weeks|||participants|||Number
655322|NCT01952665|Primary|Overall Vision Satisfaction|Participant rating of satisfaction regarding vision. After 2 weeks wear for each study pair. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied|2 weeks|||participants|||Number
655323|NCT01952665|Primary|Overall Handling Satisfaction|Participant rating of satisfaction regarding handling. After 2 weeks wear for each study pair. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied|2 weeks|||participants|||Number
655324|NCT01952665|Primary|Overall Dryness Satisfaction|Participant rating of satisfaction regarding dryness. After 2 weeks wear for each study pair. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied|2 weeks|||participants|||Number
655325|NCT01952665|Primary|Overall Comfort Satisfaction|Participant rating of satisfaction regarding comfort. After 2 weeks wear for each study pair. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied|2 weeks|||participants|||Number
655326|NCT01952665|Primary|Overall Sensation of Smoothness|Participant rating of overall sensation for smoothness (deposit resistance). After 2 weeks wear for each study pair. 5-point Likert Scale; 1=Excellent, 2=Good, 3=Average, 4=Below Average, 5=Poor.|2 weeks|||participants|||Number
655327|NCT01952665|Primary|Overall Sensation of Moistness|Participant rating of overall sensation for moistness (hydration). After 2 weeks wear for each study pair. 5-point Likert Scale; 1=Excellent, 2=Good, 3=Average, 4=Below Average, 5=Poor.|2 weeks|||participants|||Number
655328|NCT01952665|Primary|Eye Whiteness/Redness|Participant rating for Eye Whiteness/Redness. After 2 weeks wear for each study pair. (0-10, 0= Significant Redness, 10= Totally White)|2 weeks|||units on a scale||Standard Deviation|Mean
655329|NCT01952665|Primary|Vision Satisfaction|Participant rating for vision satisfaction. After 2 weeks wear for each study pair. (0-10, 0= Very Unsatisfied, 10= Very Satisfied)|2 weeks|||units on a scale||Standard Deviation|Mean
655330|NCT01952665|Primary|Handling|Participant rating for lens handling. After 2 weeks wear for each study pair. (0-10, 0= Very Difficult, 10= Very Easy).|2 weeks|||units on a scale||Standard Deviation|Mean
655331|NCT01952665|Primary|Dryness|Participant rating for lens dryness. After 2 weeks wear for each study pair. (0-10, 0= Very Dry, 10= No Dryness).|2 weeks|||units on a scale||Standard Deviation|Mean
655332|NCT01952665|Primary|Comfort|Participant rating for lens comfort. After 2 weeks wear for each study pair. (0-10, 0= Very Uncomfortable, 10= Cannot Feel).|2 weeks|||units on a scale||Standard Deviation|Mean
655333|NCT01952665|Primary|Comfortable Wearing Time|Participant rating of lens Comfortable Wearing Time for both study pairs. After 2 weeks wear for each pair. (The hours of average comfortable wearing time)|2 weeks|||hours||Standard Deviation|Mean
655334|NCT01952665|Secondary|Rewetting Drops|Participant use of rewetting drops. Collected at 2 weeks for both study lens pairs. (Uses rewetting drops / Does not use rewetting drops).|2 weeks|||participants|||Number
655335|NCT01952665|Primary|Average Daily Wearing Time|Participants measure of average daily wear time for study lenses at 2 Weeks.|2 weeks|||hours||Standard Deviation|Mean
655336|NCT01952665|Other Pre-specified|The Number of Trials Needed to Achieve Final Dispensing Pair of Study Lenses.|The number of trials needed to achieve final dispensing pair of study lenses. Number of lenses required to dispense the final pair of study lenses. Collected at dispense for both study lens pairs. (Number required; 1, 2, 3, >3)|Dispense|||number of trial lenses|lenses|Standard Deviation|Mean
657147|NCT01927120|Secondary|Overall Survival at Day +365|Overall survival will be defined as the time from transplant date to death from any cause.|365 days post HCT|All participants.||percentage of participants||95% Confidence Interval|Number
655337|NCT01952665|Secondary|Overall Fit Acceptance|Assessment of overall lens fit acceptance. Collected at dispense for both study pairs. (0-4, 0=should not be worn, 1=borderline but unacceptable, 2=minimally acceptable, early review, 3=not perfect but okay to dispense, 4=perfect)|Dispense|||units on a scale|lenses|Standard Deviation|Mean
655338|NCT01952665|Secondary|Push Up Test|Assessment of lens tightness. Collected at dispense for both study pairs. Digital push up test. Continuous Scale (0-100%, 0%=Falls from cornea without lid support, 50%= Optimum, 100%= No movement)|Dispense|||units on a scale|lenses|Standard Deviation|Mean
655339|NCT01952665|Secondary|Post Blink Movement|Assessment of post blink movement. Collected at dispense for both study lens pairs. Assessed immediately after the blink. (0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement)|Dispense|||lenses|lenses||Number
655340|NCT01952665|Secondary|Corneal Coverage|Assessment of lens corneal coverage. Collected at dispense for both study pairs. Biomicroscopy; assessed in primary gaze. (Rated as Normal Coverage or Not Covering)|Dispense|||lenses|lenses||Number
655341|NCT01952665|Secondary|Centration|Assessment of lens centration. Collected at dispense for both study pairs. Biomicroscopy; by degree and direction in the primary position. (Rated as Optimal Centration or Not Optimal)|Dispense|||lenses|lenses||Number
655342|NCT01952665|Secondary|Surface Deposition|Assessment of surface deposition by slit lamp. Collected at dispense for both study pairs. (Grade 0-4 in ½ steps; Clean= 0; Deposited = 4)|Dispense|||units on a scale|eyes|Standard Deviation|Mean
655343|NCT01952665|Secondary|Surface Wetting|Assessment of surface wetting by slit lamp. Collected at dispense for both study pairs. 0=Non-wettable surface, 1= > 1 non-wetting area of some magnitude., 2=One non-wetting area of some magnitude, 3=Hazy surface that resolves with a blink. Typical soft lens appearance with long drying time., 4=Smooth uniformly reflective surface. Appearance of a healthy cornea (Grade 0-4 in ½ steps)|Dispense|||units on a scale|eyes|Standard Deviation|Mean
655344|NCT01952665|Secondary|Binocular Visual Acuity logMAR|Assessment of visual acuity (VA). Collected at 2 weeks for both study lens pairs. Binocular High Contrast Distance. logMAR (negative logMAR values indicates better Visual Acuity (VA)). 0.0 logMAR = 20/20 snellen chart|Dispense|||logMAR||Standard Deviation|Mean
655345|NCT01952665|Primary|Visual Quality|Participant rating of visual quality. Collected at dispense for both study pairs. (0-10, 0= Very Poor Vision, 10= Perfectly Sharp, Clear Vision)|Dispense|||units on a scale||Standard Deviation|Mean
655346|NCT01952665|Primary|Comfort at Insertion|Participant rating for lens comfort on insertion. Collected at dispense for both study lens pairs. (0-10, 0= Very Uncomfortable, 10= Cannot feel).|Dispense|||units on a scale||Standard Deviation|Mean
655347|NCT01952600|Primary|Factors That Are Most Important to Patients|Differences in factors most important to patients were compared across chronic kidney disease, hemodialysis, and peritoneal dialysis patients.|Baseline|||% of patients|||Number
655348|NCT01952418|Secondary|Polyp Detection Rate (Screening Exams Only)|Number of patients with polyps detected|recorded during endoscopy (immediate)|screening exams only||Participants|||Count of Participants
655349|NCT01952418|Secondary|Polyp Detection Rate (All Indications)|Number of patients with polyps detected|recorded during endoscopy (immediate)|all indications||Participants|||Count of Participants
655350|NCT01952418|Primary|Adenoma Detection Rate (Screening Exams Only)|Number of patients with adenoma detected|within 2 weeks (range of 1 day-14 days) of the endoscopy|screening exams only||Participants|||Count of Participants
655351|NCT01952418|Primary|Adenoma Detection Rate (All Indications)|Number of patients with adenoma detected|within 2 weeks (range of 1 day-14 days) of the endoscopy|all indications||Participants|||Count of Participants
655352|NCT01952366|Secondary|Cognition (as Measured With the Mini Mental State Examination (MMSE) and Clinical Diagnosis of Dementia)|One year after inclusion to the study, there will be a clinical assessment of the patient including a MMSE, if possible, and to evaluate if the patients have dementia.|1 year after inclusion to the study||11/2017||||
655353|NCT01952366|Primary|Depression|Relapse/recurrence of depression|1 year after inclusion to the study|Inpatients||participants|||Number
655354|NCT01952366|Primary|Depression|"Response (50% improvement on the Montgomery and Asberg Depression Rating Scale (MADRS) score) Remission (defined as score of 9 or less on the MADRS)
The MADRS is a measurement of the severity of depression and consists of 10 items rated from 0 points (no symptoms) to 6 (severe symptoms)"|Patients were follow during their stay in the hospital; average days of stay in hospital = 68.3 (SD=46.8)|Patients with complete MADRS records||participants|||Number
655355|NCT01952301|Primary|Keratinized Tissue Width|Change in Keratinized Tissue width|6 months|Sample size was determined using 80% power fans assuming a paired t-test of non-inferiority with a non-inferiority margin of 1.0 mm, a within-subject standard deviation of 1.0 mm, and a one-sided alpha of 0.05, resulting in a sample size of 27. To account for potential loss-to-follow-up, 30 subjects were enrolled in the trial.||mm||Standard Deviation|Mean
655356|NCT01952145|Secondary|Number of Treatment Emergent Confirmed Hypoglycaemic Episodes|Confirmed hypoglycaemic episodes were defined as either: Severe (i.e., an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions) or an episode biochemically confirmed by a plasma glucose value of <3.1 mmol/L (56 mg/dL), with or without symptoms consistent with hypoglycaemia.|During 26 weeks of treatment|The safety analysis set was used for analysis of this endpoint and this set included all subjects receiving at least one dose of trial product. Subjects contributed to the evaluation “as treated”. Confirmed hypoglycaemic episodes were reported by 79 subjects in IdegLira arm and by 137 subjects in IGlar arm.||Number of episodes|||Number
655357|NCT01952145|Secondary|Change From Baseline in Body Weight|Change from baseline in body weight after 26 weeks of treatment|Week 0, week 26|FAS which included all randomised subjects was used for analysis of this endpoint. Missing values (including intermittent missing values) were imputed using LOCF method.||Kg||Standard Deviation|Mean
655358|NCT01952145|Primary|Change From Baseline in HbA1c (Glycosylated Haemoglobin)|Change from baseline in HbA1c after 26 weeks of treatment|Week 0, week 26|FAS was used for analysis of this endpoint. And FAS included all randomised subjects. Missing values (including intermittent missing values) were imputed using the last observation carried forward (LOCF) method.||Percentage (%)||Standard Deviation|Mean
657371|NCT01923480|Secondary|Plasma Concentration of Leucine||Three times during each 7 hour visit|One subject completed Period 1, but withdrew from the study prior to the start of Period 2.||micromol/L||Standard Deviation|Mean
655359|NCT01952080|Primary|Absolute Change in Parenteral Support (PN/IV) Volume at Week 16|Absolute change in PN/IV from the Baseline Visit to Week 16 Visit.|Baseline, Week 16|Absolute change in PN/IV volume from baseline to Week 16 based on prescribed data - Intent-to-Treat Population||Liters/week||Standard Deviation|Mean
655360|NCT01952080|Primary|Absolute Change in Parenteral Support (PN/IV) Volume at End of Treatment|Absolute change in PN/IV from the Baseline Visit to End of Treatment Visit.|Baseline, End of Treatment|Absolute change in PN/IV volume from baseline to End of Treatment based on prescribed data - Intent-to-Treat Population||Liters/week||Standard Deviation|Mean
655361|NCT01952080|Other Pre-specified|Absolute Change in Enteral Support (EN) Volume From Baseline at Week 16|Absolute change in enteral support requirements at Week 16 (liters/week)|Baseline, Week 16|Absolute change of EN volume from baseline to Week 16 based on subject diary data - Intent-to-Treat Population||Liters/week||Standard Deviation|Mean
655362|NCT01952080|Other Pre-specified|Absolute Change in Enteral Support (EN) Volume From Baseline at Week 12|Absolute change in enteral support requirements at Week 12 (liters/week)|Baseline, Week 12|Absolute change of EN volume from baseline to Week 12 based on subject diary data - Intent-to-Treat Population||Liters/week||Standard Deviation|Mean
655363|NCT01952080|Other Pre-specified|Percent Change in Enteral Support (EN) Volume From Baseline at Week 16|Percent change in enteral support requirements at Week 16 (liters/week)|Baseline, Week 16|Percent change of EN volume from baseline to Week 16 based on subject diary data - Intent-to-Treat Population||percent change||Standard Deviation|Mean
655364|NCT01952080|Other Pre-specified|Percent Change in Enteral Support (EN) Volume From Baseline at Week 12|Percent change in enteral support requirements at Week 12 (liters/week)|Baseline, Week 12|Percent change of EN volume from baseline to Week 12 based on subject diary data - Intent-to-Treat Population||percent change||Standard Deviation|Mean
655365|NCT01952080|Primary|Absolute Change in Parenteral Support (PN/IV) Volume at Week 12|Absolute change in PN/IV from the Baseline Visit to Week 12 Visit.|Baseline, Week 12|Absolute change in PN/IV volume from baseline to Week 12 based on prescribed data - Intent-to-Treat Population||Liters/week||Standard Deviation|Mean
655366|NCT01952080|Primary|Percent Change in Parenteral Support (PN/IV) Volume at Week 16|Percent change in PN/IV from the Baseline Visit to Week 16 Visit.|Baseline, Week 16|Percent change in PN/IV volume from baseline to Week 16 based on prescribed data - Intent-to-Treat Population||percent change||Standard Deviation|Mean
655367|NCT01952080|Primary|Percent Change in Parenteral Support (PN/IV) Volume at End of Treatment|Percent change in PN/IV from the Baseline Visit to End of Treatment Visit.|Baseline, End of Treatment|Percent change in PN/IV volume from baseline to End of Treatment based on prescribed data - Intent-to-Treat Population||percent change||Standard Deviation|Mean
655368|NCT01952080|Primary|Percent Change in Parenteral Support [Parenteral Nutrition (PN)/Intravenous (IV)] Volume at Week 12|Percent change in PN/IV from the Baseline Visit to Week 12 Visit.|Baseline, Week 12|Percent change in PN/IV volume from baseline to Week 12 based on prescribed data - Intent-to-Treat Population (ITT), defined as all participants who were enrolled in the study.||percent change||Standard Deviation|Mean
655369|NCT01951950|Primary|Failure of Drug to Control Systolic Blood Pressure (SBP) < 140 mmHg||1 hour postoperatively|||participants|||Number
655370|NCT01951820|Primary|Measurement of Pain Associated With Injection, in Millimeters, According to Visual Analog Scale|The investigation is trying to determine if the compounded topical anesthetic (Pliaglis) is more effective than the active control (benzocaine) in numbing the gums before needle penetration. The effectiveness of the topical anesthetics will be determined by the patient indicating their level of discomfort felt upon needle stick by using a Heft-Parker visual analog pain scale (scale of 0 - 170mm with 0mm equating to no pain and 170mm equating to maximum pain).|2.5 minutes|||mm||Full Range|Mean
655371|NCT01951703|Primary|Subjective Overall Vision (Using CLUE )|Contact Lens User Experience Vision scores (CLUE) is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.|2 weeks|Includes all subjects who completed all visits and did not have any major protocol deviation impacting the primary outcomes||units on a scale||Standard Deviation|Mean
655372|NCT01951703|Primary|Subjective Overall Comfort (Using CLUE )|Contact Lens User Experience Comfort scores (CLUE) is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.|2 weeks|Includes all subjects who completed all visits and did not have any major protocol deviation impacting the primary outcomes||units on a scale||Standard Deviation|Mean
655373|NCT01951651|Secondary|Monocyte Inflammatory Protein Nuclear Factor Kappa-B (NFkappaB) (%)|The percentage change in monocyte inflammatory proteins NFkappaB (%) from baseline.|6 months|||percentage change from baseline||Standard Error|Mean
655374|NCT01951651|Secondary|Left Ventricular Ejection Fraction (LVEF)(%).|Left Ventricular Ejection Fraction following intervention as measured by magnetic resonance imaging in patients with type 2 diabetes.|6 months|One patient assigned to the glipizide treatment arm did not complete the Left Ventricular Ejection Fraction study (magnetic resonance imaging) following 6 months of treatment||percent of Left ventricular function||Standard Error|Mean
655375|NCT01951651|Primary|Hepatic Fat Content|Hepatic fat content following intervention in patients with type 2 diabetes|6 months|One patient assigned to the glipizide treatment arm did not complete the hepatic fat content study (MRS) following 6 months of treatment||percent of hepatic fat||Standard Error|Mean
655376|NCT01951651|Primary|Myocardial Fat Content|Myocardial fat content following intervention as measured by magnetic resonance imaging and spectroscopy (MRS) in patients with type 2 diabetes.|6 months|One patient assigned to the glipizide treatment arm did not complete the myocardial fat content study (MRS) following 6 months of treatment||percentage of myocardium content||Standard Error|Mean
655377|NCT01951586|Secondary|Number of Participants With Treatment-emergent Adverse Events||From first dose of study drug until 4 weeks after last dose; median exposure to study drug was 6.77 months.|All randomized participants who received at least one dose of study drug (denosumab or placebo)||participants|||Number
655378|NCT01951586|Secondary|Serum Denosumab Trough Levels in Participants Who Received Q4W Dosing|Serum samples were analyzed for denosumab using enzyme-linked immunosorbent assay (ELISA) following a validated procedure. The lower limit of quantification for the assay was 20 ng/mL.|Prior to dosing at day 8 and weeks 4, 8, 12, 16, 20 and 24|Randomized participants who received denosumab every 4 weeks with at least one valid denosumab concentration measurement.||ng/mL||Standard Deviation|Mean
655379|NCT01951586|Secondary|Serum Denosumab Trough Levels in Participants Who Received Q3W Dosing|Serum samples were analyzed for denosumab using enzyme-linked immunosorbent assay (ELISA) following a validated procedure. The lower limit of quantification for the assay was 20 ng/mL.|Prior to dosing at day 8 and weeks 3, 6, 9, 12, 15, 18, 21 and 24.|Randomized participants who received denosumab every 3 weeks with at least one valid denosumab concentration measurement.||ng/mL||Standard Deviation|Mean
655380|NCT01951586|Secondary|Progression-free Survival (PFS)|Progression-free survival was defined as the time from randomization to the first observed disease progression per modified RECIST 1.1 criteria or death from any cause. Participants last known to be alive who did not experience disease progression were censored at their last imaging assessment date, last contact date if they were in the survival follow up phase, end of the study date, or the primary analysis cut-off date, whichever was first. If a participant underwent surgical resection while on study, the participant was censored at the last evaluable imaging assessment prior to the surgery.|From randomization until the data cut-off date of 29 July 2016; median time on study was 9.64 months.|All randomized participants||months||95% Confidence Interval|Median
655381|NCT01951586|Secondary|Clinical Benefit Rate|Clinical benefit rate was defined as the percentage of participants with an objective response (CR or PR) or stable disease (SD) or better for at least 16 weeks achieved over the study duration. If a participant underwent surgical resection while on study, the participant was not evaluated for response after the surgery. Participants who did not meet the criteria for clinical benefit by the analysis cutoff date were considered as non-responders.|From randomization until the data cut-off date of 29 July 2016; median time on study was 9.64 months.|Randomized participants with at least one baseline measurable lesion per modified RECIST 1.1.||percentage of participants|||Number
655382|NCT01951586|Secondary|Correlation of Tumor Tissue RANKL Expression With Objective Response Rate|"To assess whether the treatment effect on objective response rate (ORR) based on RECIST 1.1 was correlated with RANKL protein expression in tumor cells, RANKL expression in archival tumor samples was measured using immunohistochemistry. The intensity of stain in the cytoplasm was categorized as 0 (negative), 1+ (weak), 2+ (moderate) or 3+ (strong); All intensity is the sum of levels +1, +2 and +3. In addition, an H-score was calculated using the following formula: H-score=(percentage of cells of weak×1)+(percentage of cells of moderate×2)+(percentage of cells of strong×3). The maximum H-score was 300, corresponding to 100% of cells with strong intensity.
The correlation between RANKL expression level and ORR was evaluated within each treatment group using a logistical regression model that included RANKL expression value as an independent variable and stratified by the randomization stratification factors. The odds ratio and 95% confidence interval are reported."|From randomization until the data cut-off date of 29 July 2016; median time on study was 9.64 months.|All randomized participants with at least one baseline measurable lesion per modified RECIST 1.1 who had evaluable pre-treatment tumor RANKL expression.||odds ratio||95% Confidence Interval|Number
655383|NCT01951586|Secondary|Correlation of Tumor Tissue RANK Expression With Objective Response Rate|"To assess whether the treatment effect on objective response rate (ORR) based on RECIST 1.1 was correlated with RANK protein expression in tumor cells, RANK expression in archival tumor samples was measured using immunohistochemistry. The intensity of stain in the cytoplasm, membrane, and total was categorized as 0 (negative), 1+ (weak), 2+ (moderate) or 3+ (strong); All intensity is the sum of levels +1, +2 and +3. In addition, an H-score was calculated using the following formula: H-score=(percentage of cells of weak×1)+(percentage of cells of moderate×2)+(percentage of cells of strong×3). The maximum H-score was 300, corresponding to 100% of cells with strong intensity.
The correlation between RANK expression level and ORR was evaluated within each treatment group using a logistical regression model that included RANK expression value as an independent variable and stratified by the randomization stratification factors. The odds ratio and 95% confidence interval are reported."|From randomization until the data cut-off date of 29 July 2016; median time on study was 9.64 months.|All randomized participants with at least one baseline measurable lesion per modified RECIST 1.1 who had evaluable pre-treatment tumor RANK expression.||odds ratio||95% Confidence Interval|Number
655384|NCT01951586|Secondary|Objective Response Rate|"Objective response rate was defined as the percentage of participants with a complete response (CR) or partial response (PR) based on modified RECIST 1.1 achieved over the study duration.
CR: Disappearance of all target and non target lesions, normalization of tumor marker levels and no new lesions.
PR: At least a 30% decrease in the size of target lesions with no progression of non-target lesions and no new lesions, or, disappearance of target lesions with persistence of one or more non-target lesions and/or maintenance of tumor marker levels above normal limits and no new lesions.
Participants who underwent surgical resection while on study were not evaluated for response after the surgery. Participants who did not meet the criteria for an objective response by the analysis cutoff date were considered non-responders."|From randomization until the data cut-off date of 29 July 2016; median time on study was 9.64 months.|Randomized participants with at least one baseline measurable lesion per modified RECIST 1.1.||percentage of participants|||Number
655385|NCT01951586|Secondary|Correlation of Tumor Tissue RANK Ligand Expression With Overall Survival|"To assess whether the treatment effect on overall survival was correlated with RANK ligand (RANKL) protein expression in tumor cells, RANKL expression in archival tumor samples was measured using immunohistochemistry. The intensity of stain in the cytoplasm was categorized as 0 (negative), 1+ (weak), 2+ (moderate) or 3+ (strong); All intensity is the sum of levels +1, +2 and +3. In addition, an H-score was calculated using the following formula: H-score=(percentage of cells of weak×1)+(percentage of cells of moderate×2)+(percentage of cells of strong×3). The maximum H-score was 300, corresponding to 100% of cells with strong intensity.
The correlation between RANKL expression level and OS was evaluated using a Cox proportional hazard models that included RANKL expression level stratified by the randomization stratification factors in the corresponding treatment group."|From randomization until the data cut-off date of 29 July 2016; median time on study was 9.64 months.|All randomized participants who had evaluable pre-treatment tumor RANKL expression.||hazard ratio||95% Confidence Interval|Number
655386|NCT01951586|Secondary|Correlation of Tumor Tissue RANK Expression With Overall Survival|"To assess whether the treatment effect on overall survival was correlated with receptor activator of nuclear factor (NF)-κB (RANK) protein expression in tumor cells, RANK expression in archival tumor samples was measured using immunohistochemistry. The intensity of stain in the cytoplasm, membrane, and total was categorized as 0 (negative), 1+ (weak), 2+ (moderate) or 3+ (strong); All intensity is the sum of levels +1, +2 and +3. In addition, an H-score was calculated using the following formula: H-score=(percentage of cells of weak×1)+(percentage of cells of moderate×2)+(percentage of cells of strong×3). The maximum H-score was 300, corresponding to 100% of cells with strong intensity.
The correlation between RANK expression level and OS was evaluated using a Cox proportional hazard models that included RANK expression level stratified by the randomization stratification factors in the corresponding treatment group."|From randomization until the data cut-off date of 29 July 2016; median time on study was 9.64 months.|All randomized participants who had evaluable pre-treatment tumor RANK expression.||hazard ratio||95% Confidence Interval|Number
655387|NCT01951586|Primary|Overall Survival (OS)|Overall survival was calculated as the time from the date of randomization to the date of death from any cause. Participants last known to be alive were censored at the last contact date or the primary analysis cutoff date, whichever was first.|From randomization until the data cut-off date of 29 July 2016; median time on study was 9.64 months.|All randomized participants||months||95% Confidence Interval|Median
655388|NCT01951573|Secondary|Over-refraction (OR) Monocular at Distance|OR (the amount of additional correction needed to improve VA) at distance (equivalent to 6 meters) was assessed monocularly (for each eye separately) in diopters (D). Both eyes contributed to the mean.|Dispense (Day 1), Hour 9|This analysis population includes all randomized subjects excluding those who met any of the specified deviation criteria.||Diopters|Participants|Standard Deviation|Mean
655389|NCT01951573|Secondary|HC/HI Binocular VA at Distance|Distance VA was assessed binocularly (both eyes together) at 6 meters, with over-refraction (OR), if necessary, and measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity, with a negative value denoting better than 20/20 visual acuity.|Dispense (Day 1), Hour 9|This analysis population includes all randomized subjects excluding those who met any of the specified deviation criteria.||logMAR||Standard Deviation|Mean
655390|NCT01951573|Primary|High Contrast/High Illumination (HC/HI) Binocular Visual Acuity (VA) at Near|Near VA was assessed binocularly (both eyes together) at 40 centimeters, with over-refraction (OR), if necessary, and measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity, with a negative value denoting better than 20/20 visual acuity.|Dispense (Day 1), Hour 9|This analysis population includes all randomized subjects excluding those who met any of the specified deviation criteria.||logMAR||Standard Deviation|Mean
655391|NCT01951417|Other Pre-specified|Stinging/Burning|Cutaneous irritability assessments (stinging/burning, erythema, scaling, dryness) experienced during use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 8 weeks.|Baseline, 2, 4, and 8 weeks|As observed population||participants|||Number
655392|NCT01951417|Other Pre-specified|Dryness|Cutaneous irritability assessments (stinging/burning, erythema, scaling, dryness) experienced during use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 8 weeks.|Baseline, 2, 4, and 8 weeks|As observed population||participants|||Number
655393|NCT01951417|Other Pre-specified|Scaling|Cutaneous irritability assessments (stinging/burning, erythema, scaling, dryness) experienced during use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 8 weeks.|Baseline, 2, 4, and 8 weeks|As observed population||participants|||Number
655394|NCT01951417|Other Pre-specified|Erythema|Cutaneous irritability assessments (stinging/burning, erythema, scaling, dryness) experienced during use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 8 weeks.|Baseline, 2, 4, and 8 weeks|As observed population||participants|||Number
655395|NCT01951417|Secondary|Subject Questionnaire|Describe subject satisfaction after use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 8 weeks.|Baseline, 2, 4, and 8 weeks|ITT population (all subjects who had at least 1 post-treatment administration evaluation)||participants|||Number
655396|NCT01951417|Secondary|Non-inflammatory Lesions|The change in non-inflammatory lesions after use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 2 weeks, 4 weeks, and 8 weeks|Baseline, 2, 4, and 8 weeks|ITT population (all subjects who had at least 1 post-treatment administration evaluation)||lesions||Standard Deviation|Mean
655397|NCT01951417|Secondary|Inflammatory Lesions|The change in inflammatory lesions after use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 2 weeks, 4 weeks, and 8 weeks.|Baseline, 2, 4, and 8 weeks|ITT population (all subjects who had at least 1 post-treatment administration evaluation)||lesions||Standard Deviation|Mean
655398|NCT01951417|Primary|Total Lesion Count|The change in total lesion count after use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 2 weeks, 4 weeks, and 8 weeks.|Baseline, 2, 4, and 8 weeks|ITT population (all subjects who had at least 1 post-treatment administration evaluation)||lesions||Standard Deviation|Mean
655399|NCT01951170|Secondary|Safety: Number of Participants With Confirmed Positive Assessment of Tocilizumab Immunogenicity|A tocilizumab antibody screen was performed at baseline and at the end of follow up (8 weeks after end of treatment at Week 32). A confirmatory anti-tocilizumab antibody test was performed on positive screen samples. A confirmed positive test indicates the presence of tocilizumab antibodies.|At baseline, Week 32 (end of follow up: 8 weeks after end of treatment)|The safety population included all enrolled participants who received at least one dose of subcutaneous tocilizumab.||participants|||Number
655400|NCT01951170|Secondary|Safety: Number of AEs Leading to Tocilizumab Dose Modification or Study Treatment Withdrawal||Up to Week 32 (end of follow up: 8 weeks after end of treatment)|The safety population included all enrolled participants who received at least one dose of subcutaneous tocilizumab.||adverse events|||Number
655453|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 480 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 3: 480 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng/mL||Standard Deviation|Geometric Mean
655401|NCT01951170|Secondary|Safety: Percentage of Participants With Adverse Events (AEs)|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|Up to Week 32 (end of follow up: 8 weeks after end of treatment)|The safety population included all enrolled participants who received at least one dose of subcutaneous tocilizumab.||percentage of participants|||Number
655402|NCT01951170|Secondary|Change From Baseline in RAMRIS Scoring of Osteitis|Osteitis (bone inflammation) was assessed by MRI at baseline and Week 24. Scans of 25 bone locations were read and scored in pairs for each participant by 2 assessors. Scores for each location ranged 0-3 on a 4-point scale, with 0= no osteitis, 1= 1-33% involvement of original articular bone, 2= 34-67% involvement of original articular bone and 3= 68-100% involvement of original articular bone. Total score was the sum of the 25 individual scores and ranged 0-75 with 0= no osteitis and 75= most severe osteitis. A negative change from baseline indicates improvement.|From baseline to Week 24|FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Here, the number of participants analyzed is the number for whom evaluable baseline and Week 24 images were available.||units on a scale||Standard Deviation|Mean
655403|NCT01951170|Secondary|Change From Baseline in RAMRIS Scoring of Synovitis|Synovitis (synovial membrane inflammation) was assessed by MRI at baseline and Week 24. Scans of 8 joint locations were read and scored in pairs for each participant by 2 assessors. Scores for each location ranged 0-3 on a 4-point scale, with 0= no synovitis, 1= 1-33% volume enhancement, 2= 34-67% volume enhancement and 3= 68-100% volume enhancement. Total score was the sum of the 8 individual scores and ranged 0-24 with 0= no synovitis and 24= most severe synovitis. A negative change from baseline indicates improvement.|From baseline to Week 24|FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Here, the number of participants analyzed is the number for whom evaluable baseline and Week 24 images were available.||units on a scale||Standard Deviation|Mean
655404|NCT01951170|Secondary|Change From Baseline in RAMRIS Scoring of Cartilage Loss|Cartilage loss was assessed by MRI at baseline and Week 24. Scans of 25 joints were read and scored in pairs for each participant by 2 assessors. Scores for each location ranged 0-4 on a 9-point scale, with 0= no cartilage loss and 4= complete cartilage loss. Total score was the sum of the 25 individual scores and ranged 0-100 with 0= no cartilage loss and 100= most severe cartilage loss. A negative change from baseline indicates improvement.|From baseline to Week 24|FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Here, the number of participants analyzed is the number for whom evaluable baseline and Week 24 images were available.||units on a scale||Standard Deviation|Mean
655405|NCT01951170|Secondary|Change From Baseline in Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Scoring of Bone Erosions|Bone erosions were assessed by magnetic resonance imaging (MRI) at baseline and Week 24. Scans of 25 bone locations were read and scored in pairs for each participant by 2 assessors. Scores for each location ranged 0-10 on an 11-point scale with 0= no erosion, 1= 1-10% erosion, 2= 11-20% erosion, and up to 10= 91-100% erosion. Total score was the sum of the 25 individual scores and ranged 0-250 with 0= no erosion and 250= most severe erosion. A negative change from baseline indicates improvement.|From baseline to Week 24|FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Here, the number of participants analyzed is the number for whom evaluable baseline and Week 24 images were available.||units on a scale||Standard Deviation|Mean
655406|NCT01951170|Secondary|Change From Baseline in Swollen Joint Count (SJC)|SJC was counted based on 66 joints (SJC66) and based on 28 joints (SJC28). A negative change from baseline indicates improvement.|From baseline to Week 24|FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Participants with available data at the respective time points were analyzed.||swollen joints||Standard Deviation|Mean
655407|NCT01951170|Secondary|Change From Baseline in Total Tender Joint Count (TJC)|TJC was counted based on 68 joints (TJC68) and based on 28 joints (TJC28). A negative change from baseline indicates improvement.|From baseline to Week 24|FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Participants with available data at the respective time points were analyzed.||tender joints||Standard Deviation|Mean
655408|NCT01951170|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI)|The CDAI is a combined index for measuring disease activity in rheumatoid arthritis and calculated as CDAI = TJC28 + SJC28 + PGA VAS (in mm) + Physician Global Assessment of Disease Activity VAS (in mm) with a total CDAI score ranging from 0-76. Higher scores indicate greater disease activity. The SDAI scale is divided into the following categories: Clinical remission = score ≤ 2.8; Low disease activity = score > 2.8 and ≤ 10.0; Moderate disease activity = score > 10.0 and ≤ 22.0; Severe disease = score > 22.0. A negative change from baseline indicates improvement.|From baseline to Week 24|FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Participants with available data at the respective time points were analyzed.||units on a scale||Standard Deviation|Mean
655409|NCT01951170|Secondary|Change From Baseline in Simplified Disease Activity Index (SDAI)|The SDAI is a combined index for measuring disease activity in rheumatoid arthritis and calculated as SDAI = TJC28 + SJC28 + PGA VAS (in mm) + Physician Global Assessment of Disease Activity VAS (in mm) + C reactive protein (CRP) in milligrams/deciliter (mg/dL) with a total SDAI score ranging from 0 to 86. Higher scores indicate greater disease activity. The SDAI scale is divided into the following categories: Clinical remission = score ≤ 3.3; Low disease activity = score > 3.3 and ≤ 11.0; Moderate disease activity = score > 11.0 and ≤ 26.0; Severe disease = score > 26.0. A negative change from baseline indicates improvement.|From baseline to Week 24|FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Participants with available data at the respective time points were analyzed.||units on a scale||Standard Deviation|Mean
655454|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 336 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 3: 336 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng/mL||Standard Deviation|Geometric Mean
655410|NCT01951170|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F)|The FACIT measurement system is a collection of health-related quality of life questionnaires targeted to the management of chronic illness and includes questions on physical well-being, social/family well-being, emotional well-being and functional well-being. The FACIT-F Scale measures an individual’s level of fatigue during their usual daily activities. Total scores range from 0 to 52 with lower scores representing greater fatigue, and scores below 30 representing severe fatigue. A positive change from baseline indicates improvement.|From baseline to Week 24|FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Participants with available data at the respective time points were analyzed.||units on a scale||Standard Deviation|Mean
655411|NCT01951170|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)|HAQ-DI is the participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. A negative change from baseline indicates improvement.|From baseline to Week 24|FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Participants with available data at the respective time points were analyzed.||units on a scale||Standard Deviation|Mean
655412|NCT01951170|Secondary|Change From Baseline in Physician Global Assessment of Disease Activity|"The Physician Global Assessment of Disease Activity is the investigator's overall assessment of the participant's current disease activity. The disease activity is displayed on a 100-mm horizontal VAS. The left-hand extreme (0 mm) of the line is described as no disease activity (symptom free and no arthritis symptoms) and the right-hand extreme (100 mm) is described as maximum disease activity (maximum arthritis disease activity). The change in Physician Global Assessment of Disease Activity is determined as the difference in values from baseline. A negative change from baseline indicates improvement."|From baseline to Week 24|FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Participants with available data at the respective time points were analyzed.||units on a scale||Standard Deviation|Mean
655413|NCT01951170|Secondary|Change From Baseline in Patient’s Global Assessment of Pain Using a Visual Analog Scale (PGA Pain VAS)|"The PGA pain VAS is the participant's overall assessment of pain. Pain is displayed on a 100-mm horizontal VAS. The left-hand extreme (0 mm) of the line is described as no pain and the right-hand extreme (100 mm) is described as unbearable pain. The change in PGA VAS is determined as the difference in values from baseline. A negative change from baseline indicates improvement."|From baseline to Week 24|FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Participants with available data at the respective time points were analyzed.||units on a scale||Standard Deviation|Mean
655414|NCT01951170|Secondary|Change From Baseline in Patient’s Global Assessment of Disease Activity Visual Analog Scale (PGA VAS)|"PGA VAS is the participant's overall assessment of their current disease activity. The disease activity is displayed on a 100-mm horizontal VAS. The left-hand extreme (0 mm) of the line is described as no disease activity (symptom free and no arthritis symptoms) and the right-hand extreme (100 mm) is described as maximum disease activity (maximum arthritis disease activity). The change in PGA VAS is determined as the difference in values from baseline. A negative change from baseline indicates improvement."|From baseline to Week 24|FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Participants with available data at the respective time points were analyzed.||units on a scale||Standard Deviation|Mean
655415|NCT01951170|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Response|EULAR response was calculated as the difference between DAS28-ESR scores at baseline and Week 24, and reported as the percentage of participants with good, moderate, or no response. Good responders = decrease from baseline >1.2 with a DAS28 score of ≤3.2; moderate responders = decrease from baseline >1.2 with a DAS28 score of >3.2, or decrease from baseline >0.6 to ≤1.2 with a DAS28 score of ≤5.1; non-responders = decrease from baseline ≤0.6 or decrease from baseline >0.6 and ≤1.2 with a DAS28 score of >5.1.|From baseline to Week 24|FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab.||percentage of participants||95% Confidence Interval|Number
655416|NCT01951170|Secondary|Percentage of Participants With Positive American College of Rheumatology 20/50/70 (ACR20/50/70) Responses|A positive ACR20 response requires at least 20% improvement compared to baseline in SJC (66 joints) and TJC (68 joints) as well as at least 20% improvement in 3 of the following 5 assessments: 1) PGA pain VAS, 2) PGA VAS; 3) physician’s global assessment of disease activity VAS, 4) Health Assessment Questionnaire-Disability Index (HAQ-DI) with 20 questions consisting of 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do; and 5) acute phase reactant (C-reactive protein [CRP] - if not available, ESR was used). ACR50 and ACR70 responses are defined in a similar way except that they required a 50% and 70% improvement from baseline, respectively. VAS range for all assessments was 0=no disease activity to 100=maximum disease activity.|From baseline to Week 24|FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab.||percentage of participants||95% Confidence Interval|Number
655417|NCT01951170|Secondary|Percentage of Participants With Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR) Remission|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count of 28 joints (TJC28), swollen joint count of 28 joints (SJC28), patient's global assessment of disease activity visual analog scale (PGA VAS) with 0=no disease activity to 100=maximum disease activity displayed on the 100-millimeter (mm) horizontal VAS and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to 10. Higher scores represent higher disease activity. DAS28-ESR remission is defined as a score < 2.6.|At Week 24|FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab.||percentage of participants||95% Confidence Interval|Number
655455|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 336 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 1: 336 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng/mL||Standard Deviation|Geometric Mean
655418|NCT01951170|Primary|Change From Baseline in Genant-modified Total Sharp Score (mTSS)|The mTSS is a measure of joint damage that combines scores for bone erosion and joint-space narrowing (JNS). Erosion score: A total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=normal to 3.5=very severe erosion. JNS score: A total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=normal to 4.0=definite ankylosis (stiffness or fixation of a joint). mTSS scores ranged from 0 (normal) to 292 (worst possible total score). Change from baseline = mTSS score at Week 24 minus score at baseline. An increase in mTSS from baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.|From baseline to Week 24|Full Analysis Set (FAS) included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Here, the number analyzed represents the number of participants for whom the Week 24 X-ray was performed.||units on a scale||Full Range|Median
655419|NCT01951092|Secondary|Efficacy|Exploratory end point of PVL <200 copies at the end of the study|6 months|||participants|||Number
655420|NCT01951092|Primary|Number of Particpatns Who Considered the Intervention Feasible and Acceptable|A qualitative interview is completed at the end of the 6 month intervention where participants are queried on aspects of the texting intervention including: frequency of messaging, content of messaging, comfort with confidentiality with messaging, interactions between clinic staff as a result of messaging, and ideas on how to incorporate messaging clinic-wide.|6 months|All 20 participants who completed the study at 6 months participated in interviews and reported that the texting intervention was feasible and acceptable.||participants|||Number
655421|NCT01951066|Primary|Correlation Between Change in Level of Propermeability Factors With Change in Edema After Treatment With a Dexamethasone Implant or Anti-VEGF Agent|Changes in propermeability factor levels were correlated with changes in edema using the person correlation coefficient (this was calculated using data from all time points).|1, 2, 3, and 4 months after injection of a dexamethasone implant or anti-VEGF agent|||Pearson correlation coefficient (r)|||Number
655422|NCT01950741|Secondary|VFQ (Visual Function Questionaire)-25 Score|Quality of life was assessed using VFQ -25 score . The VFQ-25 includes 25 questions, and the total score ranges from 0 to 100. Higher scores represents better functioning.|12 months|Among 45 patients who completed the study, data of 5 were inadequate for the analysis. Forty patients were included in the analysis as per protocol set.||scores on a scale||Inter-Quartile Range|Mean
655423|NCT01950741|Secondary|Percentage of Patients Having Complete Resulution of Polypoidal Lesion in ICG Angiography|ICG angiography was assessed at 12 months. when no polypoidal lesion was detected, it was defined as complete resolution.|12 months|Among 45 patients who completed the study, data of 6 were inadequate for the analysis. 39 patients were included in the analysis.||percentage of patients|||Number
655424|NCT01950741|Secondary|Percentage of Patients With Visual Acuity >=20/40|Visual acuity was assessed using ETDRS chart. The ETDRS chart includes 100 letters as the maximum possible score, and 0 letters read as the minimum possible score. Higher scores represents better functioning. Percentage of patients with visual acuity 70 ETDRS letters (equivalent to 20/40) or better was calculated.|12 months|Among 45 patients who completed the study, data of 5 were inadequate for the analysis. Forty patients were included in the analysis as per protocol set.||percentage of patients|||Number
655425|NCT01950741|Secondary|Percentage of Patients With Visual Acuity >=20/200|Visual acuity was assessed using ETDRS chart. The ETDRS chart includes 100 letters as the maximum possible score, and 0 letters read as the minimum possible score. Higher scores represents better functioning. Percentage of patients with visual acuity 35 ETDRS letters (equivalent to 20/200) or better was calculated.|12 months|Among 45 patients who completed the study, data of 5 were inadequate for the analysis. Forty patients were included in the analysis as per protocol set.||percentage of patients|||Number
655426|NCT01950741|Secondary|Change in Visual Acuity From Baseline to 12 Months|Mean changes of visual acuity in ETDRS letters. Visual acuity was assessed using ETDRS chart. The ETDRS chart includes 100 letters as the maximum possible score, and 0 letters read as the minimum possible score. Higher scores represents better functioning. A change of 5 letters is equivalent to a 1-line change.|Baseline and 12 months|Among 45 patients who completed the study, data of 5 were inadequate for the analysis. Forty patients were included in the analysis as per protocol set.||letters||Full Range|Mean
655427|NCT01950741|Primary|Percentage of Patients Lose Visual Acuity Less Than 15 Letters|Visual acuity was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart. The ETDRS chart includes 100 letters as the maximum possible score, and 0 letters read as the minimum possible score. Visual acuity of 85 letters is equivalent to 20/20. Higher scores represents better functioning.|12 months|Among 45 patients who completed the study, data of 5 were inadequate for the analysis. Forty patients were included in the analysis as per protocol set.||percentage of patients|||Number
655428|NCT01950663|Primary|Per Patient Referral Accuracy|Accuracy will be reported as count of participants with referral status correctly identified, sensitivity, and specificity, with ETDRS photography and reading as the gold standard.|During a single visit, implicit time, measured by the RETeval device, and ETDRS photography, will be performed to support the analysis of the accuracy of the RETeval device.|Participants with gradeable fundus photos and RETeval measurements||Participants|||Count of Participants
655429|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 480-504 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 3: 480-504 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng||Standard Deviation|Geometric Mean
655430|NCT01950364|Secondary|Number of Participants With Clinically Significant Change From Baseline in Vital Signs|Vital signs included body temperature, body weight, blood pressure and heart rate.|Baseline up to 30 days after last dose of study drug (30 Days after Cycle 16)|Safety analysis set included all participants who received at least 1 dose of study drug.||participants|||Number
656215|NCT01939938|Primary|AHI|The AHI is the number of apneas or hypopneas recorded during the study per hour of sleep. It is generally expressed as the number of events per hour.|through study completion, an average of 1 hour|||events per hour||Standard Deviation|Mean
655431|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 336-360 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 3: 336-360 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng||Standard Deviation|Geometric Mean
655432|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 144-168 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 3: 144-168 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng||Standard Deviation|Geometric Mean
655433|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 120-144 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 3: 120-144 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng||Standard Deviation|Geometric Mean
655434|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 96-120 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 3: 96-120 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng||Standard Deviation|Geometric Mean
655435|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 72-96 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 3: 72-96 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng||Standard Deviation|Geometric Mean
655436|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 48-72 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 3: 48-72 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng||Standard Deviation|Geometric Mean
655437|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 24-48 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 3: 24-48 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng||Standard Deviation|Geometric Mean
655438|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 0-24 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 3: 0-24 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng||Standard Deviation|Geometric Mean
655439|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, Predose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 3: Predose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng||Standard Deviation|Geometric Mean
655440|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 480-504 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 1: 480-504 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng||Standard Deviation|Geometric Mean
655441|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 336-360 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 1: 336-360 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng||Standard Deviation|Geometric Mean
655442|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 144-168 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 1: 144-168 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng||Standard Deviation|Geometric Mean
655443|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 120-144 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 1: 120-144 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng||Standard Deviation|Geometric Mean
655444|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 96-120 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 1: 96-120 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng||Standard Deviation|Geometric Mean
655445|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 72-96 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 1: 72-96 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng||Standard Deviation|Geometric Mean
655446|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 48-72 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 1: 48-72 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng||Standard Deviation|Geometric Mean
655447|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 24-48 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 1: 24-48 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng||Standard Deviation|Geometric Mean
655448|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 0-24 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 1: 0-24 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng||Standard Deviation|Geometric Mean
655449|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, Predose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 1: Predose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng||Standard Deviation|Geometric Mean
655450|NCT01950364|Secondary|Number of Participants With Markedly Abnormal Laboratory Values|The number of participants with any markedly abnormal standard safety laboratory values collected throughout study.|Baseline up to 30 days after last dose of study drug (30 Days after Cycle 16)|Safety analysis set included all participants who received at least 1 dose of study drug.||participants|||Number
655451|NCT01950364|Secondary|Number of Participants With Anti-therapeutic Antibodies (ATA) to Brentuximab Vedotin|Participants with positive ATA at both Cycle 1 and 3, negative ATA at both Cycle 1 and 3, and transient positive (positive at one time point, but negative at the other) ATA for brentuximab vedotin were reported.|Day 1 of Cycle 1 and 3|Safety analysis set included all participants who received at least 1 dose of study drug.||participants|||Number
655452|NCT01950364|Secondary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event. AEs included both SAE and non-SAE.|Baseline up to 30 days after last dose of study drug (30 days after Cycle 16)|Safety analysis set included all participants who received at least 1 dose of study drug.||participants|||Number
655456|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 144 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 3: 144 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng/mL||Standard Deviation|Geometric Mean
655457|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 144 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 1: 144 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng/mL||Standard Deviation|Geometric Mean
655458|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 96 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 3: 96 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng/mL||Standard Deviation|Geometric Mean
655459|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 96 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 1: 96 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng/mL||Standard Deviation|Geometric Mean
655460|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 72 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 3: 72 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng/mL||Standard Deviation|Geometric Mean
655461|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 72 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 1: 72 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng/mL||Standard Deviation|Geometric Mean
655462|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 48 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 3: 48 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng/mL||Standard Deviation|Geometric Mean
655463|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 48 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 1: 48 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng/mL||Standard Deviation|Geometric Mean
655464|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 24 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 3: 24 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng/mL||Standard Deviation|Geometric Mean
655465|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 24 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 1: 24 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng/mL||Standard Deviation|Geometric Mean
655466|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 4 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 3: 4 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng/mL||Standard Deviation|Geometric Mean
655467|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 4 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 1: 4 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng/mL||Standard Deviation|Geometric Mean
655468|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 0.5 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 3: 0.5 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng/mL||Standard Deviation|Geometric Mean
655469|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 2, 0.5 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 2: 0.5 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng/mL||Standard Deviation|Geometric Mean
655470|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 0.5 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 1: 0.5 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng/mL||Standard Deviation|Geometric Mean
655606|NCT01947907|Primary|AUEC0-168h of IGF-1|"As part of the following endpoint:
PD profile of serum IGF-1 during V1 and V3 compared between the ACP-001 dose groups and to the rhGH group.
Uncorrected AUEC0-168 (area under the efficacy curve from 0h-168h) values at Week 13"|0 hours to 168 hours at Visit 3 (Week 13)|||h*ng/mL||Standard Deviation|Mean
655471|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, Predose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 3: Predose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng/mL||Standard Deviation|Geometric Mean
655472|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 2, Predose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 2: Predose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng/mL||Standard Deviation|Geometric Mean
655473|NCT01950364|Secondary|Serum Concentration of Total Antibody (TAb)|The LLQ for all the observations was 12.5 ng/mL.|Cycle 1 and 3: Predose, 0.5, 4, 72, 336 hours post-dose; Cycle 2: Predose, 0.5 hours post-dose; Cycle 3: 480 hours post-dose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng/mL||Standard Deviation|Geometric Mean
655474|NCT01950364|Secondary|Serum Concentrations of Antibody-drug Conjugate (ADC)|The LLQ for all the observations was 12.5 ng/mL.|Cycle 1 and 3: Predose, 0.5, 4, 72, 336 hours post-dose; Cycle 2: Predose, 0.5 hours post-dose; Cycle 3: 480 hours post-dose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng/mL||Standard Deviation|Geometric Mean
655475|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, Predose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The lower limit of Quantification (LLQ) for all the observations was 0.01 nanogram/milliliter (ng/mL).|Cycle 1: Predose|Pharmacokinetic (PK) analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng/mL||Standard Deviation|Geometric Mean
655476|NCT01950078|Secondary|Preoperative Pressure Pain Tolerance (PTO)|"The probe of pressure algometer was positioned perpendicularly to the skin surface of the patient, and the investigator applied continuous pressure at approximately the same rate according to the visual LCD display on the algometer. subjects were asked to say ok when they started to feel the pain became intolerable during the stimulation. The value from the LCD was recorded as the pressure pain tolerance."|30 minutes before the operation|||kg/cm2||Standard Deviation|Mean
655477|NCT01950078|Primary|Preoperative Pressure Pain Threshold (PPT)|"The probe of pressure algometer was positioned perpendicularly to the skin surface of the patient, and the investigator applied continuous pressure at approximately the same rate according to the visual LCD display on the algometer. subjects were asked to say pain when they started to feel pain during the stimulation. The value from the LCD was recorded as the pressure pain threshold."|30 minutes before the operation|||kg/cm2||Standard Deviation|Mean
655478|NCT01949870|Primary|The Number of Dose-limiting Toxicities|The number of dose-limiting toxicities in selumetinib in combination with cisplatin and gemcitabine|The first cycle with selumetinib until Day 1 of Cycle 2 of combination dosing|Evaluable = completed at least 75% of planned daily doses of selumetinib at least 50% of planned dose of cisplatin/gemcitabine planned on Cycle 1 Day 8 (therefore, in total with Cycle 1 Day 1, at least 75 % of planned dose is given in Cycle 1) and has enough information to be assessed for the combination regimen dose escalation.||Participants|||Number
655479|NCT01949545|Secondary|Number of Participants With Adverse Events (AEs)|"Treatment-related adverse events (TRAEs) are adverse events considered related to carfilzomib by the investigator, including those with unknown relationship.
Adverse events were graded using National Cancer Institute’s Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 4.03, on a scale from 1 (mild) to 5 (death)."|From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks|||participants|||Number
655480|NCT01949545|Secondary|Mean Residence Time (MRT) for Metabolite PR-519/M16||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization||hours||Geometric Coefficient of Variation|Geometric Mean
655481|NCT01949545|Secondary|Terminal Half-life for Metabolite PR-519/M16||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization||hours||Geometric Coefficient of Variation|Geometric Mean
655482|NCT01949545|Secondary|Time to Maximum Plasma Concentration (Tmax) for Metabolite PR-519/M16||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population||hours||Full Range|Median
655483|NCT01949545|Secondary|Maximum Plasma Concentration (Cmax) for Metabolite PR-519/M16||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population||ng/mL||Geometric Coefficient of Variation|Geometric Mean
655484|NCT01949545|Secondary|Area Under the Concentration Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) for Metabolite PR-519/M16||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
655485|NCT01949545|Secondary|Area Under the Concentration Time Curve From Time Zero to Last Concentration Measured (AUC0-last) for Metabolite PR-519/M16||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
655607|NCT01947907|Primary|Emax of IGF-1|"As part of the following endpoint:
PD profile of serum IGF-1 during V1 and V3 compared between the ACP-001 dose groups and to the daily rhGH group"|0 hours to 168 hours at Visit 3 (Week 13)|||ng/mL||Standard Deviation|Mean
655486|NCT01949545|Secondary|Mean Residence Time (MRT) for Metabolite PR-413/M15||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization||hours||Geometric Coefficient of Variation|Geometric Mean
655487|NCT01949545|Secondary|Terminal Half-life for Metabolite PR-413/M15||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization||hours||Geometric Coefficient of Variation|Geometric Mean
655488|NCT01949545|Secondary|Time to Maximum Plasma Concentration (Tmax) for Metabolite PR-413/M15||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population||hours||Full Range|Median
655489|NCT01949545|Secondary|Maximum Plasma Concentration (Cmax) for Metabolite PR-413/M15||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population||ng/mL||Geometric Coefficient of Variation|Geometric Mean
655490|NCT01949545|Secondary|Area Under the Concentration Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) for Metabolite PR-413/M15||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
655491|NCT01949545|Secondary|Area Under the Concentration Time Curve From Time Zero to Last Concentration Measured (AUC0-last) for Metabolite PR-413/M15||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
655492|NCT01949545|Secondary|Mean Residence Time (MRT) for Metabolite PR-389/M14||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization||hours||Geometric Coefficient of Variation|Geometric Mean
655493|NCT01949545|Secondary|Terminal Half-life for Metabolite PR-389/M14||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization||hours||Geometric Coefficient of Variation|Geometric Mean
655494|NCT01949545|Secondary|Time to Maximum Plasma Concentration (Tmax) for Metabolite PR-389/M14||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population||hours||Full Range|Median
655495|NCT01949545|Secondary|Maximum Plasma Concentration (Cmax) for Metabolite PR-389/M14||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population||ng/mL||Geometric Coefficient of Variation|Geometric Mean
655496|NCT01949545|Secondary|Area Under the Concentration Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) for Metabolite PR-389/M14||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
655497|NCT01949545|Secondary|Area Under the Concentration Time Curve From Time Zero to Last Concentration Measured (AUC0-last) for Metabolite PR-389/M14||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population, defined as all participants who had adequate carfilzomib exposure and plasma concentration versus time data for the estimation of PK parameters by a non-compartmental analysis at each time point.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
655498|NCT01949545|Secondary|Volume of Distribution at Steady State (Vss) of Carfilzomib 56 mg/m²||Cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization||liters||Geometric Coefficient of Variation|Geometric Mean
655499|NCT01949545|Secondary|Mean Residence Time (MRT) of Carfilzomib 56 mg/m²||Cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization||hours||Geometric Coefficient of Variation|Geometric Mean
655500|NCT01949545|Secondary|Clearance of Carfilzomib 56 mg/m²||Cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization||L/hour||Geometric Coefficient of Variation|Geometric Mean
655501|NCT01949545|Secondary|Terminal Half-life of Carfilzomib 56 mg/m²||Cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization||hours||Geometric Coefficient of Variation|Geometric Mean
656659|NCT01932606|Secondary|Change in Central Pressures After Study Drug (Exercise)|Values are exercise values after receiving study drug minus exercise values before study drug (on the same day.)|baseline, approximately 30 minutes after study drug administration|||mm Hg||Standard Deviation|Mean
655502|NCT01949545|Secondary|Time to Maximum Plasma Concentration (Tmax) of Carfilzomib 56 mg/m²||Cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population||hours||Full Range|Median
655503|NCT01949545|Secondary|Maximum Plasma Concentration (Cmax) of Carfilzomib 56 mg/m²||Cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population||ng/mL||Geometric Coefficient of Variation|Geometric Mean
655504|NCT01949545|Secondary|Area Under the Concentration Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Carfilzomib 56 mg/m²|The area under the curve from time zero extrapolated to infinity (AUC0-inf) following intravenous administration of carfilzomib 56 mg/m² on day 1 of cycle 2 was calculated using a non-compartmental approach, from the individual plasma concentration profiles of carfilzomib.|Cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
655505|NCT01949545|Secondary|Area Under the Concentration Time Curve From Time Zero to Last Concentration Measured (AUC0-last) of Carfilzomib 56 mg/m²|The area under the curve from time zero to the last concentration measured (AUC0-last) following intravenous administration of carfilzomib 56 mg/m² on day 1 of cycle 2 was calculated using a non-compartmental approach, from the individual plasma concentration profiles of carfilzomib.|Cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
655506|NCT01949545|Secondary|Volume of Distribution at Steady State (Vss) of Carfilzomib 27 mg/m²||Cycle 1 day 16 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization||liters||Geometric Coefficient of Variation|Geometric Mean
655507|NCT01949545|Secondary|Mean Residence Time (MRT) of Carfilzomib 27 mg/m²||Cycle 1 day 16, pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization||hours||Geometric Coefficient of Variation|Geometric Mean
655508|NCT01949545|Secondary|Terminal Half-life of Carfilzomib 27 mg/m²||Cycle 1 day 16, pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization||hours||Geometric Coefficient of Variation|Geometric Mean
655509|NCT01949545|Secondary|Clearance of Carfilzomib 27 mg/m²||Cycle 1 day 16, pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization||L/hour||Geometric Coefficient of Variation|Geometric Mean
655510|NCT01949545|Secondary|Time to Maximum Plasma Concentration (Tmax) of Carfilzomib 27 mg/m²||Cycle 1 day 16, pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population||hours||Full Range|Median
655511|NCT01949545|Secondary|Maximum Plasma Concentration (Cmax) of Carfilzomib 27 mg/m²||Cycle 1 day 16, pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population||ng/mL||Geometric Coefficient of Variation|Geometric Mean
655512|NCT01949545|Primary|Area Under the Concentration Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Carfilzomib 27 mg/m²|The area under the curve from time zero extrapolated to infinity (AUC0-inf) following intravenous administration of carfilzomib 27 mg/m² on day 16 of cycle 1 was calculated using a non-compartmental approach, from the individual plasma concentration profiles of carfilzomib.|Cycle 1 day 16, pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
655513|NCT01949545|Primary|Area Under the Concentration Time Curve From Time Zero to Last Concentration Measured (AUC0-last) of Carfilzomib 27 mg/m²|The area under the curve from time zero (defined as the start of carfilzomib infusion) to the last concentration measured (AUC0-last) following intravenous administration of carfilzomib 27 mg/m² on day 16 of cycle 1 was calculated using a non-compartmental approach, from the individual plasma concentration profiles of carfilzomib.|Cycle 1 day 16, pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population, defined as participants who received the intended carfilzomib dose (27 or 56 mg/m²) and who had plasma concentration versus time data for the estimation of each pharmacokinetic (PK) parameter by a non-compartmental analysis.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
655527|NCT01949532|Secondary|Maximum Observed Plasma Concentration for Metabolite PR-389/M14||Cycle 1, day 16 and cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population; one participant was excluded due to samples taken from the infusion arm, distal to the infusion site.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
655541|NCT01949532|Secondary|Terminal Half-life (T½) of Carfilzomib Following 56 mg/m² Carfilzomib on Day 1 of Cycle 2||Cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population for cycle 2, day 1. One participant was excluded due to samples taken from the infusion arm, distal to the infusion site.||hours||Full Range|Median
655514|NCT01949532|Secondary|Number of Participants With Adverse Events (AEs)|"Determination of the severity of all adverse events was assessed following the National Cancer Institute’s Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 4.03, where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Fatal.
A Serious AE is an AE that meets one or more of the following criteria:
Death,
Life-threatening experience;
Requires in-patient hospitalization or prolongation of an existing hospitalization,
Results in persistent or significant disability/incapacity,
Is a congenital anomaly/birth defect,
Important medical events that may not result in death, be life-threatening, or require hospitalization.
Treatment-related adverse events (TRAEs) are adverse events considered related to carfilzomib by the investigator, including those with unknown relationship."|From the first dose of study drug up to 30 days after the last dose of study drug as of the data cut-off date of 12 October 2015; median duration of treatment was 14 weeks in the normal renal function group and 12 weeks in the ESRD group.|All treated participants||participants|||Number
655515|NCT01949532|Secondary|Terminal Half-life (T½) of Metabolite PR-519/M16||Cycle 1, day 16 and cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population; one participant was excluded due to samples taken from the infusion arm, distal to the infusion site.||hours||Full Range|Median
655516|NCT01949532|Secondary|Time to Maximum Observed Plasma Concentration (Tmax) for Metabolite PR-519/M16||Cycle 1, day 16 and cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population; one participant was excluded due to samples taken from the infusion arm, distal to the infusion site.||hours||Full Range|Median
655517|NCT01949532|Secondary|Maximum Observed Plasma Concentration (Cmax) for Metabolite PR-519/M16||Cycle 1, day 16 and cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population; one participant was excluded due to samples taken from the infusion arm, distal to the infusion site.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
655518|NCT01949532|Secondary|Area Under the Concentration Time Curve From Time 0 Extrapolated to Infinity (AUC0-∞) for Metabolite PR-519/M16||Cycle 1, day 16 and cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population; one participant was excluded due to samples taken from the infusion arm, distal to the infusion site.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
655519|NCT01949532|Secondary|Area Under the Concentration Time Curve From Time 0 to Last Concentration (AUC0-last) for Metabolite PR-519/M16||Cycle 1, day 16 and cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population; one participant was excluded due to samples taken from the infusion arm, distal to the infusion site.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
655520|NCT01949532|Secondary|Terminal Half-life (T½) of Metabolite PR-413/M15||Cycle 1, day 16 and cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population. One participant was excluded due to samples taken from the infusion arm, distal to the infusion site. Participants for whom the extrapolated portion of AUC0-∞ was > 20% were excluded.||hours||Full Range|Median
655521|NCT01949532|Secondary|Time to Maximum Observed Plasma Concentration (Tmax) for Metabolite PR-413/M15||Cycle 1, day 16 and cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population; one participant was excluded due to samples taken from the infusion arm, distal to the infusion site.||hours||Full Range|Median
655522|NCT01949532|Secondary|Maximum Observed Plasma Concentration (Cmax) for Metabolite PR-413/M15||Cycle 1, day 16 and cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population; one participant was excluded due to samples taken from the infusion arm, distal to the infusion site.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
655523|NCT01949532|Secondary|Area Under the Concentration Time Curve From Time 0 Extrapolated to Infinity (AUC0-∞) for Metabolite PR-413/M15||Cycle 1, day 16 and cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population. One participant was excluded due to samples taken from the infusion arm, distal to the infusion site. Participants for whom the extrapolated portion of AUC0-∞ was > 20% were excluded.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
655524|NCT01949532|Secondary|Area Under the Concentration Time Curve From Time 0 to Last Concentration (AUC0-last) for Metabolite PR-413/M15||Cycle 1, day 16 and cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population; one participant was excluded due to samples taken from the infusion arm, distal to the infusion site.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
655525|NCT01949532|Secondary|Terminal Half-life (T½) of Metabolite PR-389/M14||Cycle 1, day 16 and cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population. Participants for whom the extrapolated portion of AUC0-∞ was > 20% were excluded. T½ could not be calculated for the ESRD group as the extrapolated portion (AUCextr) was greater than 20% in all participants.||hours||Full Range|Median
655526|NCT01949532|Secondary|Time to Maximum Observed Plasma Concentration (Tmax) for Metabolite PR-389/M14||Cycle 1, day 16 and cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population; one participant was excluded due to samples taken from the infusion arm, distal to the infusion site.||hours||Full Range|Median
655608|NCT01947907|Primary|E-Trough of IGF-1|"As part of the following endpoint:
PD profile of serum IGF-1 during Visit 1 and Visit 3 compared between the ACP-001 dose groups and to the daily rhGH group
Uncorrected E-Trough (the pre-dose efficacy response) values at Week 13"|0 hours to 168 hours at Visit 3 (Week 13)|||ng/mL||Standard Deviation|Mean
655528|NCT01949532|Secondary|Area Under the Concentration Time Curve From Time 0 Extrapolated to Infinity (AUC0-∞) for Metabolite PR-389/M14||Cycle 1, day 16 and cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population. Participants for whom the extrapolated portion of AUC0-∞ was > 20% were excluded. AUC0-∞ could not be calculated for the ESRD group as the extrapolated portion (AUCextr) was greater than 20% in all participants.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
655529|NCT01949532|Secondary|Area Under the Concentration Time Curve From Time 0 to Last Concentration (AUC0-last) for Metabolite PR-389/M14||Cycle 1, day 16 and cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|"PK evaluable population; One participant was excluded due to samples taken from the infusion arm, distal to the infusion site. n indicates the number of participants included in the analyses at each time point."||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
655530|NCT01949532|Secondary|Volume of Distribution at Steady State (Vss) of Carfilzomib Following 27 mg/m² Carfilzomib on Day 16 of Cycle 1||Cycle 1, day 16 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population for cycle 1, day 16. One participant was excluded due to samples taken from the infusion arm, distal to the infusion site.||liters||Geometric Coefficient of Variation|Geometric Mean
655531|NCT01949532|Secondary|Mean Residence Time (MRT) of Carfilzomib Following 27 mg/m² Carfilzomib on Day 16 of Cycle 1||Cycle 1, day 16 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population for cycle 1, day 16. One participant was excluded due to samples taken from the infusion arm, distal to the infusion site. Participants with a coefficient of correlation (R²) < 0.8 were excluded.||hours||Geometric Coefficient of Variation|Geometric Mean
655532|NCT01949532|Secondary|Clearance (CL) of Carfilzomib Following 27 mg/m² Carfilzomib on Day 16 of Cycle 1||Cycle 1, day 16 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population for cycle 1, day 16. One participant was excluded due to samples taken from the infusion arm, distal to the infusion site.||liters/hour||Geometric Coefficient of Variation|Geometric Mean
655533|NCT01949532|Secondary|Terminal Half-life (T½) of Carfilzomib Following 27 mg/m² Carfilzomib on Day 16 of Cycle 1||Cycle 1, day 16 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population for cycle 1, day 16. One participant was excluded due to samples taken from the infusion arm, distal to the infusion site. Participants with a coefficient of correlation (R²) < 0.8 were excluded.||hours||Full Range|Median
655534|NCT01949532|Secondary|Time to Maximum Observed Plasma Concentration (Tmax) of Carfilzomib Following 27 mg/m² Carfilzomib on Day 16 of Cycle 1||Cycle 1, day 16 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population for cycle 1, day 16. One participant was excluded due to samples taken from the infusion arm, distal to the infusion site.||hours||Full Range|Median
655535|NCT01949532|Secondary|Maximum Observed Plasma Concentration (Cmax) of Carfilzomib Following 27 mg/m² Carfilzomib on Day 16 of Cycle 1||Cycle 1, day 16 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population for cycle 1, day 16. One participant was excluded due to samples taken from the infusion arm, distal to the infusion site.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
655536|NCT01949532|Secondary|Area Under the Concentration Time Curve From Time 0 Extrapolated to Infinity (AUC0-∞) of Carfilzomib Following 27 mg/m² Carfilzomib on Day 16 of Cycle 1||Cycle 1, day 16 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population for cycle 1, day 16. One participant was excluded due to samples taken from the infusion arm, distal to the infusion site. Participants for whom the coefficient of correlation (R²) was < 0.8 were excluded.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
655537|NCT01949532|Secondary|Area Under the Concentration Time Curve From Time 0 to Last Concentration (AUC0-last) of Carfilzomib Following 27 mg/m² Carfilzomib on Day 16 of Cycle 1||Cycle 1, day 16 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population for cycle 1, day 16. One participant was excluded due to samples taken from the infusion arm, distal to the infusion site.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
655538|NCT01949532|Secondary|Volume of Distribution at Steady State (Vss) of Carfilzomib Following 56 mg/m² Carfilzomib on Day 1 of Cycle 2||Cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population for cycle 2, day 1. One participant was excluded due to samples taken from the infusion arm, distal to the infusion site.||liters||Geometric Coefficient of Variation|Geometric Mean
655539|NCT01949532|Secondary|Mean Residence Time (MRT) of Carfilzomib Following 56 mg/m² Carfilzomib on Day 1 of Cycle 2||Cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population for cycle 2, day 1. One participant was excluded due to samples taken from the infusion arm, distal to the infusion site.||hours||Geometric Coefficient of Variation|Geometric Mean
655540|NCT01949532|Secondary|Clearance (CL) of Carfilzomib Following 56 mg/m² Carfilzomib on Day 1 of Cycle 2||Cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population for cycle 2, day 1. One participant was excluded due to samples taken from the infusion arm, distal to the infusion site.||liters/hour||Geometric Coefficient of Variation|Geometric Mean
656677|NCT01932060|Primary|Total Estimated Blood Loss|Blood loss will be measured volumetrically (based on measured volume of blood within the suction chamber) and gravimetrically (based on blood weight on blood soaked laps).|immediately at end of surgery|||ml||Inter-Quartile Range|Median
655542|NCT01949532|Secondary|Time to Maximum Observed Plasma Concentration (Tmax) of Carfilzomib Following 56 mg/m² Carfilzomib on Day 1 of Cycle 2||Cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population for cycle 2, day 1. One participant was excluded due to samples taken from the infusion arm, distal to the infusion site.||hours||Full Range|Median
655543|NCT01949532|Secondary|Maximum Observed Plasma Concentration (Cmax) of Carfilzomib Following 56 mg/m² Carfilzomib on Day 1 of Cycle 2||Cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population for cycle 2, day 1. One participant was excluded due to samples taken from the infusion arm, distal to the infusion site.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
655544|NCT01949532|Primary|Area Under the Concentration Time Curve From Time 0 Extrapolated to Infinity (AUC0-∞) of Carfilzomib Following 56 mg/m² Carfilzomib on Day 1 of Cycle 2||Cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population for cycle 2, day 1. One participant was excluded due to samples taken from the infusion arm, distal to the infusion site.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
655545|NCT01949532|Primary|Area Under the Concentration Time Curve From Time 0 to Last Concentration (AUC0-last) of Carfilzomib Following 56 mg/m² Carfilzomib on Day 1 of Cycle 2|Carfilzomib plasma concentrations for pharmacokinetic (PK) analyses were measured by liquid chromatography with tandem mass spectrometry. The lower limit of quantitation (LLOQ) for the assay was 0.3 ng/mL.|Cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population for cycle 2, day 1. The PK evaluable population is defined as participants with sufficient carfilzomib plasma concentration versus time data for the estimation of PK parameters by non-compartmental analysis on cycle 1, day 16 and/or cycle 2, day 1. One participant was excluded due to samples taken from the infusion arm.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
655546|NCT01949389|Primary|Completion of All 7 Modules of the Intervention|"Participants will be followed for the duration of the intervention (7 individual modules, completed weekly, for an expected average of 7 weeks). Outcome measure will be characterized as the number completing all 7 modules of the program (dichotomous variable).
The intervention is a 7-week, self-administered course accessed via the Internet that includes instruction on psycho-education, stimulus control, relaxation training, sleep restriction, medication tapering, cognitive distortions, and mindfulness integrated into each module. Homework is assigned after each module. Participants are instructed to complete the sleep diary included in the program daily while participating in the program."|on average 7 weeks|||participants|||Number
655547|NCT01949389|Primary|Insomnia Severity Index (Total), Change From Baseline to Follow-up|"Insomnia Severity Index (Total) following completion of the intervention (expected average of 7 weeks)
The Insomnia Severity Index is a self-report seven-item measure that targets the subjective symptoms and functional consequences of insomnia as well as the degree of concerns or distress caused by those difficulties, and corresponds to the diagnostic criteria of insomnia. Scores range from 0-28, higher scores indicate more severe insomnia, and scores ≥15 suggest moderate to severe insomnia."|pre-intervention, intervention completion (expected average of 7 weeks)|The number of individuals provided access to the program and reporting baseline and follow-up data||units on a scale||Standard Deviation|Mean
655548|NCT01949155|Secondary|Microbiological Response|Subjects whose samples tested positive for bacteria in either or both ears at baseline with documented eradication or presumed eradication post-baseline.|Day 15 - 2 weeks after dosing|Microbiologically Evaluable Set||percentage of Microbiological response|||Number
655549|NCT01949155|Secondary|Evaluation of Adverse Events, Otoscopic Exams, Audiometry and Tympanometry|Safety variables included the frequency of adverse events (AEs) and results from otoscopic examinations, tympanometry, audiometry measurements.|Up to one month|Safety Analysis Set (number of ears is equivalent to number of participants)||percentage of ears|||Number
655550|NCT01949155|Primary|Percentage of Participants Who Were Treatment Failures.|"Cumulative proportion of treatment failures:
The efficacy endpoint for both trials was the cumulative proportion of study treatment failures through Day 15, defined as the occurrence of any of the following events: otorrhea as determined by a blinded assessor on or after 3 days post-surgery, otic or systemic antibacterial drug use for any reason any time post-surgery, as well as patients who missed visits or were lost-to-follow-up."|Day 15 - 2 weeks after dosing|Full Analysis Set||percentage of treatment failures|||Number
655551|NCT01949142|Secondary|Microbiological Response|Subjects whose samples tested positive for bacteria in either or both ears.|Day 15 - 2 weeks after dosing|Microbiologically Evaluable Set||percentage of Microbiological response|||Number
655552|NCT01949142|Secondary|Evaluation of Adverse Events, Otoscopic Exams, Audiometry, and Tympanometry|Safety variables included the frequency of adverse events (AEs) and results from otoscopic examinations, tympanometry, audiometry, vital sign measurements, and physical examinations.|Up to one month|Safety Analysis Set (number of ears is equivalent to number of participants)||percentage of ears|||Number
655553|NCT01949142|Primary|Percentage of Participants Who Were Treatment Failures|"Cumulative proportion of treatment failures:
The efficacy endpoint for both trials was the cumulative proportion of study treatment failures through Day 15, defined as the occurrence of any of the following events: otorrhea as determined by a blinded assessor on or after 3 days post-surgery, otic or systemic antibacterial drug use for any reason any time post-surgery, as well as patients who missed visits or were lost-to-follow-up."|Day 15 - 2 weeks after dosing|Full Analysis Set||percentage of treatment failures|||Number
655563|NCT01948830|Secondary|The Average Number of Days Between Injections|The average dosing interval was measured as the average number of days between injections|Month 12|Full Analysis Set (FAS) comprised all patients to whom treatment regimen had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment regimen they were assigned to at randomization||days||Standard Deviation|Mean
655564|NCT01948830|Secondary|The Mean Number of Treatment Frequency|The number of injections received|Month 12|Full Analysis Set (FAS) comprised all patients to whom treatment regimen had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment regimen they were assigned to at randomization||Number of injections||Standard Deviation|Mean
655554|NCT01949051|Secondary|Weighted Mean of the Symptom Scores for the Four Individual Components of the Total Nasal Symptom Score (TNSS) (Nasal Congestion, Rhinorrhea, Nasal Itching and Sneezing) (0-4) Hours Post Start of the Allergen Chamber Challenge on Day 8|TNSS contains symtom scores for the four individual components (nasal congestion [NACG], rhinorrhea [RHSCR], nasal itching [NAITS] and sneezing [SNZS]), each scored on a 0 - 3 scale [0=none, 1=mild, 2=moderate, 3=severe]). TNSS was measured at the pre-allergen chamber challenge, and then every 15 minutes from 0 to 4 hours post start of the allergen chamber challenge. In the Environmental Exposure Chamber (EEC), aerosolized allergen is administered in a sealed chamber to evaluate the efficacy of antihistamines/other treatments. The participants recorded their symptom scores on an e-diary. The mean score for each participant was calculated using the available diary data from the assessment periods, taking the average of non-missing data during the period. Weighted mean of the individual symptoms of theTNSS were calculated by dividing the value of the area under the response time curve over the 0-4 hours (calculated by trapezoidal rule) by the time interval of available data.|Day 8 of each treatment period (up to 13 Weeks)|ITT Population. Only those participants contributing data at the indicated time points were analyzed.||Scores on a scale||95% Confidence Interval|Least Squares Mean
655555|NCT01949051|Primary|Weighted Mean of the Total Nasal Symptom Score (TNSS) (0-4) Hours (h) Post Start of Allergen Chamber Challenge on Day 8|The TNSS (score of 0-12) is defined as the sum of the symptom scores for the four individual components (nasal congestion, rhinorrhea, nasal itch, and sneezing, each scored on 0-3 scale [0=none, 1=mild, 2=moderate, 3=severe]). TNSS was measured at the pre-allergen chamber challenge, and then every 15 minutes from 0 to 4 hours post start of the allergen chamber challenge. In the Environmental Exposure Chamber (EEC), aerosolized allergen was administered in a sealed chamber to evaluate the efficacy of antihistamines/other treatments. Weighted mean TNSS was calculated by dividing the value of the area under the response time curve over the 0-4 hours (calculated by trapezoidal rule) by the time interval of available data.|Day 8 of each treatment period (up to 13 Weeks)|Per Protocol Population: all participants in the Intent-to-Treat Population (defined as all participants who were randomized and received >= 1 dose of study medication) and not identified as full protocol deviators with respect to criteria that were considered to impact the primary efficacy analysis. Only those participants contributing data at the||Scores on a scale||95% Confidence Interval|Least Squares Mean
655556|NCT01948908|Secondary|Number of Patients With Physicians Who Were Satisfied or Very Satisfied With Ease of Medication Administration|This outcome is designed to examine MD satisfaction with ease of administration of intranasal medication - physicians who expressed that they were satisfied or very satisfied with ease of medication administration will be counted.|60 minutes|||participants|||Number
655557|NCT01948908|Secondary|Observational Scale of Behavioral Distress - Revised|The Observational Scale of Behavioral Distress - revised (OSBD-r) is an eight-factor, weighted observational scale used to measure distress associated with medical procedures in children 1 to 20 years of age. The total OSBD-r score is the sum of the OSBD-r scores for predetermined clinically relevant phases of the procedure, with each phase assigned a score from 0 to 23.5 (0=no distress, 23.5=maximum distress), based on the frequency and types of behaviors observed during a pre-determined number of 15-second intervals during each phase.|60 minutes|||units||95% Confidence Interval|Mean
655558|NCT01948908|Primary|Median Time (Minutes) After Administration of Intranasal Midazolam Until Patient Achieves Minimal Sedation|This outcome is designed to examine time to onset of minimal sedation, defined as a University of Michigan Sedation Score (UMSS) of 1.|20 minutes|||minutes||95% Confidence Interval|Median
655559|NCT01948830|Secondary|Change From Baseline in Composite Score of the National Eye Institute-Visual Function Questionnaire-25 (NEI-VFQ-25)|The survey consisted of 25 items representing 11 vision related constructs (general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision) plus a single-item general health rating question. The score of each individual question ranged from 0 (worst) to 100 which indicates the best possible response. The composite score and score of each of each construct also ranged from 0 to 100 as they are calculated as total scores divided by the number of questions. The higher the values of total scores represent better outcome|Baseline, Month 12|The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was considered for the analysis. Only patients with the value for both Baseline and post-baseline value at the specific visit were included for this analysis||Score on a scale||Standard Deviation|Mean
655560|NCT01948830|Secondary|Percentage of Patients With Choroidal Neovascularization (CNV) Leakage Assessed by Fluorescein Angiography (FA) in the Study Eye at|To evaluate presence of active CNV leakage on fluorescein angiography (FA) by reading center over time up to Month 12. The full analysis set was used for this evaluation but the count presented are the counts of patients in the specific treatment group who have a value for the presence of leakage at study completion. These total counts are used as the denominator for the percentages.|Month 12|Full Analysis Set (FAS) comprised all patients to whom treatment regimen had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment regimen they were assigned to at randomization.||Percentage of participants|||Number
655561|NCT01948830|Secondary|Change in Central Subfield Retinal Thickness (CSFT) Over Time|OCT (optical coherence tomography) was used to assess CSFT (Central Sub-Field Thickness) representing the average retinal thickness of the circular area within 1 mm diameter around the foveal center. The Ns in the rows is the number of patients with a value for both baseline and the specific post-baseline visit|Month 12|The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was considered for the analysis. Only patients with the value for both Baseline and the specific post-baseline visit were included for this analysis.||microns||Standard Deviation|Mean
655562|NCT01948830|Secondary|Percentage of Participants With Fluid Free Macula Over Time up to Month 12|OCT (optical coherence tomography) was used to assess intra-retinal fluid as Measured by SD-OCT (Spectral Domain-Optical Coherence Tomography). Fluid free macula refers to absence of macular edema (as assessed by the reading center). The full analysis set was used for this evaluation but the count presented are the counts of patients in the specific treatment group who have a value for the macular edema (center involvement) at study completion. These total counts are used as the denominator for the percentages|Month 12|Full Analysis Set (FAS) comprised all patients to whom treatment regimen had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment regimen they were assigned to at randomization||Percentage of participants|||Number
655565|NCT01948830|Secondary|Number of Patients With a BCVA Value of ≥ 73 Letters (Approximate 20/40 Snellen Chart Equivalent) at Month 12|Best Corrected Visual Acuity (BCVA) was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at baseline and month 12 while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. BCVA above 73 letters at Month 12 indicates a positive outcome|Baseline and every month for 12 months|The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was considered for the analysis. Only patients with the value for both Baseline and the specific post-baseline visit were included for this analysis.||Number of participants|||Number
655566|NCT01948830|Secondary|Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit|Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters.Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters.|Baseline and every month for 12 months|The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was considered for the analysis. Only patients with the value for both Baseline and the specific post-baseline visit were included for this analysis.||Number of participants|||Number
655567|NCT01948830|Secondary|Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An increased score indicates improvement in acuity. This outcome assessed the number of participants who had improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 letters of visual acuity at Month 12 as compared with baseline|Baseline and every month for 12 months|The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was considered for the analysis. Only patients with the value for both Baseline and the specific post-baseline visit were included for this analysis.||Number of participants|||Number
655568|NCT01948830|Secondary|Mean Change in Visual Acuity BCVA (Letters) From Baseline to Month 12|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) -like charts while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. For the mean change of best corrected visual acuity at Month 12 and compare to Baseline|Baseline and every month for 12 months|The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was considered for the analysis. Only patients with the value for both Baseline and the specific post-baseline visit.||Letters (EDTRS)||Standard Deviation|Mean
655569|NCT01948830|Secondary|Average BCVA Change From Baseline to Month 12|"Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters.
Mean Visual Acuity was averaged over all monthly assessments from Baseline to Month 12"|Baseline and every month for 12 months|The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was considered for the analysis. Only patients with the value for both Baseline and average visual acuity (VA) from month 1 to study completion were included in this analysis.||Letters (EDTRS)||Standard Deviation|Mean
655570|NCT01948830|Secondary|Change in BCVA From Baseline to Month 12|Best Corrected Visual Acuity (BCVA) was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart at baseline and month 12 while participants were in a sitting position at a testing distance of 4 meters|Baseline to Month 12|The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was considered for the analysis. Only patients with the value for both Baseline and study completion after last observational carried forward (LOCF) were included in this analysis. LOCF was used as an imputation of missing data.||Letters (EDTRS)||Standard Deviation|Mean
655571|NCT01948830|Secondary|Number of Visits Scheduled|The number of visits scheduled according to the treat and extend regimen after treatment initiation|From Month1 to Month 11|The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was analyzed.||Number of visits||Standard Deviation|Mean
655572|NCT01948830|Primary|Change in Best Corrected Visual Acuity (BCVA) From Baseline to Month 12|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. A positive average change from baseline of BCVA indicates improvement|Baseline to month 12|The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was considered for the analysis. Only patients with the value for both Baseline and study completion after last observational carried forward (LOCF) were included in this analysis. LOCF was used as an imputation of missing data.||Letters (EDTRS)||Standard Error|Least Squares Mean
655573|NCT01948791|Secondary|Change From Baseline in Caregiver Burden Inventory (CBI) Score|CBI, formulated by Novak and Guest in 1989, is a relatively complete and effective scale to measure caregiver burden that has been extensively adopted internationally. CBI has a total of 24 items in 5 domains, i.e., time dependency items (items 1-5), development items (items 6-10), physical health items (items 11-14), social relations items (items 15-18), and emotional heath items (items 19-24). Each item is scored on a 5-point scale based on the intensity of burden (0-4 points), so that the total score is 0-96, a higher score indicating heavier burden. It is a self-administered scale that takes about 10-15 minutes to complete. Two-sided 95% CI of the difference in the means between baseline and post-baseline values were calculated.|Baseline, Week 16|The Per Protocol (PP) population included all patients who had been enrolled to receive treatment, had received at least 1 dose of study drug, had 1 baseline assessment & at least 1 post-baseline efficacy assessment for primary efficacy variable within the Week 16 visit window & had no major protocol violations.||units on a scale||95% Confidence Interval|Mean
655582|NCT01948375|Secondary|Degree of Acupuncture Pain|"The pain of acupuncture is assessed using visual analogue scale (VAS), where 0 means no pain, and 10 means the imaginable severest pain. The VAS value of each period is used to compare the difference of acupuncture pain between the placebo needle and the real needle.
A lower value represented a better outcome, which indicated that needles used induced less pain."|in the third acupuncture session in each period|||units on a scale||Standard Deviation|Mean
656706|NCT01931865|Primary|Number of Participants With a Significant Reduction in Pain|visual analogue scale (VAS), a line which represents the level of pain in 10cms and you will show where your pain is on this line (0 no pain, 10 worst pain). A significant reduction is 2 grades on the scale.|12 weeks|||participants|||Number
655574|NCT01948791|Secondary|Mean Change From Baseline in Neuropsychiatric Inventory (NPI) Score|This scale assesses a larger scope of the behavior problems/disorders experienced in dementia patients, and identifies the frequency & severity of the behavior disorders, & allows rapid assessment using screening questions. 10 questions in behavior domain & 2 in autonomic nervous system domain were assessed by the investigator interviewing with the caregiver. The NPI-12 total score is the total score of the 12 items, among which the score for each domain is the product of frequency (range: 1–4 points) and severity (range: 1–3 points). The highest score for each domain is 12 points and all the domains have the same weight. Therefore the range of NPI-12 total score is 0–144 points. The NPI-10 total score is the total score of the first 10 items 0-120, which constitute the original form of this scale. A higher NPI total score indicates more severe behavior disorder. Two-sided 95% CI of the difference in the means between baseline and post-baseline values were calculated.|Baseline, Week 16|The Per Protocol (PP) population included all patients who had been enrolled to receive treatment, had received at least 1 dose of study drug, had 1 baseline assessment & at least 1 post-baseline efficacy assessment for primary efficacy variable within the Week 16 visit window & had no major protocol violations.||units on a scale||95% Confidence Interval|Mean
655575|NCT01948791|Secondary|Change From Baseline in Mini-Mental State Examination (MMSE)|MMSE was used to determine patient’s eligibility to participate, is an easy & practical screening test to identify cognitive disorders. Test consists of 2 parts: language (time orientation, registration & attention) & performance (recall, response to written/verbal commands, writing ability & reproduction of complex polygons); total score range: 0-30; higher score = better function. Positive change score = improvement from baseline. To meet eligibility criteria, patient’s MMSE total score at screening had to be 10-26 (inclusive). Interpretation of MMSE by 4 methods: Single Cut0ff: <24=abnormal; Range: <21=Increased odds of dementia; >25=Decreased odds of dementia; Education: 21- abnormal for 8th grade education, <23=abnormal for high school education, <24=abnormal for college education; Severity: 24-30=no cognitive impairment, 18-23=mild cognitive impairment, 0-17=severe cognitive impairment. 2-sided 95% CI of difference in means between baseline & post-baseline values were calculated|Baseline, Week 16|The Per Protocol (PP) population included all patients who had been enrolled to receive treatment, had received at least 1 dose of study drug, had 1 baseline assessment & at least 1 post-baseline efficacy assessment for primary efficacy variable within the Week 16 visit window & had no major protocol violations.||units on a scale||95% Confidence Interval|Mean
655576|NCT01948791|Secondary|Change From Baseline in the Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Score|ADCS-ADL is a scale based on caregiver’s assessment of patient’s activities of daily life. It is used in clinical studies on dementia & consists of 23 items and is designed to assess patient’s basic & instrumental activities of daily life, such as the abilities necessary for personal care, communicating & interacting with other people, maintaining a household, conducting hobbies & interests, & making judgments & decisions. Response to each item is obtained by interview with the caregiver. The basic activities of daily life domain includes mandatory options for best response, or “yes” or “no” questions with separate sub-questions. Higher score & more “yes” answers indicate better level of self-care of patient. Therefore the higher the total score is, the better the patient’s functions. The total score is the sum of the scores of all the items & sub-questions,& ranges from 0 to 78. Two-sided 95% CI of the difference in the means between baseline and post-baseline values were calculated.|Baseline, Week 16|The Per Protocol (PP) population included all patients who had been enrolled to receive treatment, had received at least 1 dose of study drug, had 1 baseline assessment & at least 1 post-baseline efficacy assessment for primary efficacy variable within the Week 16 visit window & had no major protocol violations.||units on a scale||95% Confidence Interval|Mean
655577|NCT01948791|Primary|Mean Change From Baseline in the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog)|The Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog) was used to measure change in cognitive function. Alzheimer’s disease assessment scale (ADAS) is a scale to measure specific cognitive and behavior disorders in Alzheimer disease (AD) patients. The Alzheimer’s disease assessment scale-cognitive subscale (ADAS-Cog) provides a total score range 0-70, and consists of 11 items with lower score indicating lighter impairment and higher total scores indicating more impairment. A negative change score indicates improvement from baseline. Two-sided 95% CI of the difference in the means between baseline and post-baseline values were calculated.|Baseline, Week 16|The Per Protocol (PP) population included all patients who had been enrolled to receive treatment, and who had received at least 1 dose of study drug, had 1 baseline assessment & at least 1 post-baseline efficacy assessment for primary efficacy variable within the Week 16 visit window, and had no major protocol violations.||units on a scale||95% Confidence Interval|Mean
655578|NCT01948518|Secondary|Change in 6 Minute Walk Distance|The change in 6 minutes walk distance from baseline one hour after receiving 20 mg of sildenafil orally will be measured.|Baseline and one hour|||feet||Standard Deviation|Mean
655579|NCT01948518|Primary|Change in Diffusion Capacity Measured at Baseline and One Hour.|Determine the acute effect of oral sildenafil on diffusion capacity in patients with diffuse parenchymal lung disease and concomitant pulmonary hypertension|Baseline and one hour|||ml/min/mmHg||Standard Deviation|Mean
655580|NCT01948375|Secondary|Analysis of Factors Influencing Subject Blinding|The success of blinding was defined as the subject’s perception of needle penetration. Factors influencing subject blinding to be analyzed mainly referred to data of demography, needle type, acupuncture experience, needle sensation, acupuncture pain, and needle acceptability in the third acupuncture in each period.|in the third acupuncture session in each period||||||
655581|NCT01948375|Secondary|Acceptability of the Acupuncture Needle|"After the third acupuncture of each period, participants are asked to show their acceptance toward the needles with a 5-point scale: very difficult to accept, a little difficult to accept, acceptable, easy to accept, very easy to accept.
The needle acceptability between the placebo needle and real needle are compared.
Data of the acceptability of the placebo needle included rows 1-5, i.e., rows of placebo needle: very difficult to accept, placebo needle: a little difficult to accept, placebo needle: acceptable, placebo needle: easy to accept and placebo needle: very easy to accept.
Data of the acceptability of the real needle included rows 6-10, i.e., rows of real needle: very difficult to accept, real needle: a little difficult to accept, real needle: acceptable, real needle: easy to accept and real needle: very easy to accept."|in the third acupuncture session in each period|||participants|||Number
655583|NCT01948375|Secondary|Southampton Needle Sensation Questionnaire—Degree of Needle Sensation|"The degree of needle sensation between the placebo needle and the real needle were compared.
The data of degree of needle sensation of the placebo needle included rows 1-4,i.e,, rows of placebo needle:no, placebo needle: mild, placebo needle: moderate and placebo needle: severe.
The data of degree of needle sensation of the real needle included rows 5-8, i.e., rows of real needle: no, ‘real needle: mild, real needle: moderate, and real needle: severe."|in the third acupuncture session in each period|||participants|||Number
655584|NCT01948375|Secondary|Southampton Needle Sensation Questionnaire—Type of Needle Sensation|This questionnaire is used to collect the types and degree of needle sensation experienced by participants. Information is collected after the third acupuncture session in each period. The difference between two kinds of needles is to be analyzed.|in the third acupuncture session in each period|||participants|||Number
655585|NCT01948375|Primary|Proportion of Volunteers’Perception of Needle Penetration Between the Pragmatic Placebo Needle and Real Needle.|"The primary outcome was the proportion of volunteers’perception of needle penetration between the placebo needle and the real needle in the third acupuncture session in each period.
LI4, on the dorsum of the hand, between the first and second metacarpal bones, approximately in the center of the second metacarpal bone; RN12, on the upper abdomen,4 cun above the umbilicus,on the anterior midline; BL36, on the back of the thigh,on the midpoint of the inferior gluteal crease; BL25, on the loin, 1.5 cun lateral to the lower border of the spinous process of the fourth lumbar vertebra."|in the third acupuncture session in each period|||participants|||Number
655586|NCT01948193|Primary|Percentage of Participants With Vaccine Response After Vaccinations With Sanofi Pasteur’s DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of a Commercial Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth|Anti-pertussis toxin (PT) and anti-filamentous hemagglutinin (FHA) antibodies were measured with an ELISA. Vaccine response was defined as percentage of participants with post-dose 3 anti-PT and anti-FHA antibody concentrations in ELISA units (EU)/mL ≥ 4 x Lower Limit of Quantification (LLOQ) if pre-vaccination concentration was < 4 x LLOQ or ≥ pre-vaccination concentration if pre-vaccination concentrations ≥ 4 x LLOQ.|Pre-dose 1 to one month post-dose 3|Vaccine response was assessed in the Per-protocol Analysis Set.||Percentage of participants|||Number
655587|NCT01948193|Secondary|Percentage of Participants Reporting Solicited Injection-site or Systemic Reaction After Each Vaccination With Sanofi Pasteur’s DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of Oral Poliovirus and Recombinant Hep B Vaccine at Birth|Injection-site reactions: Tenderness, Erythema, and Swelling. Systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3 Injection site reactions: Tenderness, Cries when injected limb is moved, or reduced movement of injected limb; Erythema and Swelling, ≥50 mm. Grade 3 Systemic reactions: Fever, >39.5°C or >103.1°F; Vomiting, ≥6 episodes/24 hours or requires parenteral hydration; Crying abnormal, >3 hours; Drowsiness, Sleeping most of the time/difficult to wake up; Appetite lost, Refuses ≥3 or most feeds/meals; Irritability, Inconsolable.|Within 7 days after each vaccine injection|Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set.||Percentage of participants|||Number
655588|NCT01948193|Secondary|Geometric Mean Titer Ratios of Antibodies Against Vaccine Antigens After Vaccinations With Sanofi Pasteur’s DTaP-IPV-HB-PRP-T Combined Vaccine After a Documented Dose of Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth|Diphtheria antibodies were measured by a toxin neutralization test, PT and FHA antibodies by an ELISA, and Hep B antibodies were measured by VITROS ECi/ECiQ Immunodiagnostic System.|Pre-dose 1 to one month post-dose 3|Geometric mean titer ratios were assessed in the Per-protocol Analysis Set.||Titer ratio||95% Confidence Interval|Geometric Mean
655589|NCT01948193|Secondary|Geometric Mean Titers of Antibodies Against Vaccine Antigens After Vaccinations With Sanofi Pasteur’s DTaP-IPV-HB-PRP-T Combined Vaccine After a Documented Dose of an Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth|Diphtheria antibodies were measured by a toxin neutralization test, tetanus, PT, and FHA antibodies by an ELISA, PRP antibodies by a Farr type radioimmunoassay, poliovirus 1, 2, and 3 antibodies by a neutralization assay, and Hep B antibodies were measured by VITROS ECi/ECiQ Immunodiagnostic System.|Pre-dose 1 to one month post-dose 3|Geometric mean titers were assessed in the Per-protocol Analysis Set.||Titers||95% Confidence Interval|Geometric Mean
655590|NCT01948193|Primary|Percentage of Participants With Seroprotection After Vaccinations With Sanofi Pasteur’s DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of a Commercial Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth|"Diphtheria antibodies were measured by a toxin neutralization test, tetanus antibodies by an enzyme-linked immunosorbent assay (ELISA), Haemophilus influenzae type b polysaccharide (PRP) antibodies by Farr type radioimmunoassay, poliovirus 1, 2, and 3 antibodies by a neutralization assay, and Hepatitis B (Hep B) antibodies were measured by VITROS ECi/ECiQ Immunodiagnostic System.
Description of seroprotection: Diphtheria and Tetanus antibody concentrations ≥0.01 International Units (IU)/mL; Poliovirus 1, 2, and 3 titers ≥8 (1/dilution); Hep B concentrations ≥10 mIU/mL, and PRP ≥0.15 µg/mL."|Pre-dose 1 to one month post-dose 3|Seroprotection was assessed in the Per-protocol Analysis Set.||Percentage of participants|||Number
655591|NCT01948193|Secondary|Percentage of Participants With Seroprotection Before and After Vaccinations With Sanofi Pasteur’s DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of a Commercial Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth|"Diphtheria antibodies were measured by a toxin neutralization test, tetanus antibodies by an enzyme-linked immunosorbent assay (ELISA), Haemophilus influenzae type b polysaccharide (PRP) antibodies by Farr type radioimmunoassay, poliovirus 1, 2, and 3 antibodies by a neutralization assay, and Hepatitis B (Hep B) antibodies were measured by VITROS ECi/ECiQ Immunodiagnostic System.
Description of seroprotection: Diphtheria and Tetanus antibody concentrations ≥0.01 International Units (IU)/mL; Poliovirus 1, 2, and 3 titers ≥8 (1/dilution); Hep B concentrations ≥10 mIU/mL, and PRP ≥0.15 µg/mL."|Pre-dose 1 to one month post-dose 3|Seroprotection was assessed in the Per-protocol Analysis Set.||Percentage of participants|||Number
655592|NCT01948141|Secondary|Progression Free Survival|Progression-free survival (PFS) was defined as the time from study entry to the first of either disease progression or death.|Time from study entry to the first of either disease progression or death, assessed up to 3 years|All treated patients||months||95% Confidence Interval|Median
657372|NCT01923480|Secondary|Plasma Concentration of Isoleucine||Three times during each 7 hour visit|One subject completed Period 1, but withdrew from the study prior to the start of Period 2.||micromol/L||Standard Deviation|Mean
655593|NCT01948141|Secondary|Incidence of Adverse Events (AEs)|Percentage of participants with adverse events. Incidence of Adverse Events (AEs) was Accessed by the National Cancer Institute (NCI) CTCAE Version 4.0.|Up to 30 days post-treatment|All treated and eligible patients. No statistics computed due to all patients had AEs in both groups.||percentage of participants||95% Confidence Interval|Number
655594|NCT01948141|Secondary|Tumor Response Rate|Tumor Response rate was defined as the proportion of patients who had Complete Response (CR) or Partial Response (PR) by RECIST 1.1 Criteria. Complete Response (CR): Disappearance of all target lesions. Any lymph nodes must have a reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|Up to 3 years|All treated and eligible patients. No statistics computed due to all patients were non-response in both groups.||percentage of participants||95% Confidence Interval|Number
655595|NCT01948141|Secondary|Overall Survival (OS)|Overall survival (OS) was defined as the time from study entry to death from any cause.|From study entry to death from any cause, assessed up to 3 years|||months||95% Confidence Interval|Median
655596|NCT01948141|Secondary|6-month PFS Rate for Each of the FGFRI Amplified Groups (Low, Intermediate, High) in Comparison to Historical Controls|The 6-month PFS rate was defined as the proportion of patients who were alive and progression-free at 6 months after start of study treatment.|Time from study entry to the first of either disease progression or death, assessed at 6 months|No comparison was done do versus historical controls because it was inappropriate due to the small number of patients available.|||||
655597|NCT01948141|Secondary|Compare the 6-month PFS Rate for Each FGFR1 Amplified Group (Low, Intermediate, and High) Versus FGFR1 Non-amplified Patients.|The 6-month PFS rate was defined as the proportion of patients who were alive and progression-free at 6 months after start of study treatment.|Time from study entry to the first of either disease progression or death, assessed at 6 months|All treated and eligible patients. One participant was not done due to not enough tissue.||percentage of participants|||Number
655598|NCT01948141|Secondary|Compare the 6-month PFS Rate for the Entire FGFR1 Amplified Group Versus the FGFR1 Non-amplified Patients.|The 6-month PFS rate was defined as the proportion of patients who were alive and progression-free at 6 months after start of study treatment.|Time from study entry to the first of either disease progression or death, assessed at 6 months|All treated and eligible patients. One participant was not done due to not enough tissue.||percentage of participants|||Number
655599|NCT01948141|Primary|6-month Progression Free Survival (PFS) Rate Within the Entire FGFR1 Amplified Group|The 6-month PFS rate was defined as the proportion of patients who were alive and progression-free at 6 months after start of study treatment. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.|At 6 months|All patients in FGFR1 amplified group||percentage of participants||95% Confidence Interval|Number
655600|NCT01948076|Secondary|Improvement in Diagnostic Ability Within the Intervention Group|"For the secondary outcome, we assessed whether there was an improvement in the diagnostic ability of those in the intervention group using traditional physical examination techniques as compared to using the ultrasound device. We compared the two arms using the average physical findings correctly identified as present or absent as reflected by a Present Score (average # of findings identified out of 17 possible findings) and Absent Score (average # of findings identified out of 95 possible). The residents used a examination form to indicate whether or not they felt the physical abnormality was present or absent using their physical exam alone and then again after using the ultrasound. This was compared with the gold standard which was presence or absence of the abnormality on professional ultrasound."|one month|||units on a scale||Inter-Quartile Range|Mean
655601|NCT01948076|Primary|Comparison of Diagnostic Ability of the Intervention Group's Ultrasound Exam to the Control Group's Physical Exam|"The primary outcome is a comparison of the diagnostic ability of the intervention group as recorded after performing an ultrasound exam and the control group using traditional physical examination techniques. We compared the two groups using the average physical findings correctly identified as present or absent as reflected by a Present Score (average # of findings identified out of 17 possible findings) and Absent Score (average # of findings identified out of 95 possible). The former is a gauge of a resident's ability to correctly identify present abnormalities while the latter is an assessment of correctly identifying a normal examination when findings are absent. The residents used a examination form to indicate whether or not they felt the physical abnormality was present or absent and how confident he or she was in their answer. This was compared with the gold standard which was presence or absence of the abnormality on professional ultrasound."|one month|All residents were analyzed. There was one withdrawal due to family emergency||units on a scale||Inter-Quartile Range|Mean
655602|NCT01948063|Primary|CoQ10 Levels|Total CoQ10 levels (mcg/mL) at 24 hours post study drug admission.|24 hours after study drug administration|||(mcg/mL)||Inter-Quartile Range|Median
655603|NCT01948050|Primary|Pain Intensity|"Measured on the 11 point numerical paid rating scale with anchor points 0 = no pain and 10 = worst pain possible. The outcome measure Pain intensity assessed as a change between baseline and post tDCS stimulation (after stimulation day 5). The calculated change in the range of positive numbers indicates decreased pain intensity post-treatment (eg. baseline 6; post treatment 4; change +2 indicating decrease of pain intensity by 2 points). Similarly, change in range of negative numbers indicates a worsening of pain intensity (eg. baseline 6; post treatment 8; change -2)."|Assessed at baseline and post tDCS stimulation day 5|||Points on numerical rating scale||Standard Error|Mean
655604|NCT01947946|Primary|Asthma Exacerbations Over 48 Weeks Treatment|The number of asthma exacerbations over 48 weeks treatment will be counted|48 weeks treatment|Patients from the full analysis set will be used. All patients randomized and receiving any investigational product will be included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.||Number of events|||Number
655605|NCT01947907|Secondary|Annualized Height Velocity|Annualized HV during treatment with ACP-001 or daily rhGH at the end of 6 months, for each ACP-001 dose group and for the daily rhGH dose group|Baseline to 6 months (Visit 5)|||cm/year||Standard Deviation|Mean
657373|NCT01923480|Secondary|Plasma Concentration of Histidine||Three times during each 7 hour visit|One subject completed Period 1, but withdrew from the study prior to the start of Period 2.||micromol/L||Standard Deviation|Mean
655609|NCT01947907|Primary|AUC0-168h of hGH|"As part of the following endpoint:
PK profile of serum hGH from ACP-001 treated patients compared between ACP-001 dose groups and to the PK profile of hGH from the daily rhGH group during Visit 1 and Visit 3
Uncorrected AUC0-168h (area under the curve from 0h to 168h) values at Visit 3 (Week 13)"|0 hours to 168 hours at Visit 3 (Week 13)|||h*ng/mL||Standard Deviation|Mean
655610|NCT01947907|Primary|Cmax of hGH|"As part of the following endpoint:
PK profile of serum hGH from ACP-001 treated patients compared between ACP-001 dose groups and to the pharmacokinetic (PK) profile of hGH from the daily rhGH groups during visit 1 and 3.
Uncorrected Cmax (maximum value of concentration) values at Visit 3 (Week 13)"|0 hours to 168 hours at Visit 3 (Week 13)|||ng/mL||Standard Deviation|Mean
655611|NCT01947907|Primary|Number of Subjects Reporting Local Tolerability Events (Assessed by the Patient and Investigator)|Assessment of local tolerability was performed by examining injection sites (by the investigator during study visits) and on the basis of anamnestic data and records in the Patient Diary. Assessments included pain, redness, bruising, swelling, and itching. Every subject was counted only once within each symptom category.|Start of study treatment through Visit 5 (Week 27)|||Number of subjects with any symptom|||Number
655612|NCT01947907|Primary|Incidence of Anti-hGH Neutralizing Antibody Formation|Number of subjects with positive results for anti-hGH neutralizing antibodies at two consecutive post-dose visits|Visit 2 - Visit 5|||participants|||Number
655613|NCT01947907|Primary|Incidence of Anti-hGH Binding Antibody Formation|Number of subjects with positive results for anti-hGH binding antibodies at two consecutive post-dose visits|Visit 2 - Visit 5|Safety analysis set includes all patients who receive at least one dose of planned study medication||participants|||Number
655614|NCT01947855|Primary|Change in Area Under the Concentration-time Curve (AUC1-4h) for Postprandial Plasma Glucose From Baseline After 28 Days of Treatment|The primary endpoint is the change in AUC1-4h for postprandial plasma glucose based on meal tolerance test from baseline after 28 days of treatment. Baseline refers to the last observation prior to administration of randomised study medication.|1h, 1.5h, 2h, 2.5, 3h, 3.5h and 4h after drug administration at day -1 (baseline), and 1h, 1.5h, 2h, 2.5, 3h, 3.5h and 4h after drug administration at day 28|Full analysis set||mg*h/dL||Standard Error|Least Squares Mean
655615|NCT01947582|Secondary|Number of Persons With Change in Muscle Activity Using Surface Electromyography (EMG)|Surface EMG is done on key muscles in the lower extremity (quadriceps, anterior tibialis, gastrocnemius, soleus) during computerized gait assessment. Changes in amplitude of muscle activity or timing of muscle activity would indicate, for example, increases in strength or changes in timing of muscles which might indicate motor learning as a result of wearing the ankle foot orthosis.|Assessed at visit 2 (week 1) and week 24|||persons|||Number
655616|NCT01947582|Secondary|Change in Step Length Using the GAITRite Computerized Gait Analysis System|Participants will be asked to walk on a 12-16 foot long vinyl pad placed on the floor.|Assessed at visit 2 (week 1) and week 24|||cm|||Number
655617|NCT01947582|Secondary|Change in Impact of MS on Fatigue Using the 12-Item Walk Scale|The 12-Item Walk Scale is a paper and pencil test that asks persons with MS to rate their level of fatigue when doing functional tasks. The maximum possible score is 60 points and the lowest possible score is 12. Higher scores indicate a greater impact on walking than lower scores.|Assessed at visit 2 (week 1) and week 24|||difference of sum of score|||Number
655618|NCT01947582|Primary|Change in Walking Distance During 6-Minute Walk Test|Each participant walks at a self-selected velocity on level surfaces for 6 minutes. They will be allowed to use assistive devices if necessary. They will be asked to rate their level of exertion upon completion of walking on the rate of perceived exertion scale.|Assessed at visit 2 (week 1) and week 24|||feet|||Number
655619|NCT01947517|Secondary|Tear Meniscus Height|Meniscus height measured in mm|6 months|||mm||Standard Deviation|Mean
655620|NCT01947517|Secondary|National Eye Institute Grading for Conjunctival Staining|The conjunctival staining is divided into 6 zones. Each zone received a score for staining with lissamine green. Grade 0= no staining, grade 1= trace staining, grade 2= mild staining, grade 3= moderate staining, grade 4= severe staining. Data from different zones was combined and the total value was averaged.|6 months|||Scores on a scale||Standard Deviation|Mean
655621|NCT01947517|Secondary|National Eye Institute Corneal Fluorescein Staining Pattern|The cornea is divided into 5 zones, and the inferior zone 5 was assessed for staining pattern. Grade 0= no staining, grade 1= trace staining, grade 2= mild staining, grade 3= moderate staining, and grade 4= severe staining.|6 months|||Scores on a scale||Standard Deviation|Mean
655622|NCT01947517|Secondary|Canadian Dry Eye Assessment Score|Describes the scores on a scale and range from 0-3. Higher score represents more severe dry eye. Score 0 = no dry eye symptoms, score 1 = mild dry eye symptoms, score 2 = moderate dry eye symptoms, score 3 = severe dry eye symptoms.|6 months|||scores on a scale||Standard Deviation|Mean
655623|NCT01947517|Primary|Length of Retention||6 months|||months||Standard Deviation|Mean
655624|NCT01947491|Primary|Percentage of Participants With Success According to the Investigator Global Assessment (IGA)|IGA of clear or almost clear|Day 15|Efficacy was only done on DFD01 Spray and Vehicle Spray. Protocol specifically noted no efficacy would be done on comparator or its vehicle.||percentage of patients||95% Confidence Interval|Number
655625|NCT01947335|Secondary|Incidence of Contrast-induced Nephropathy|Increase >= 0.5 mg/dl in basal serum creatinine|7 days|||percentage of participants|||Number
655626|NCT01947335|Secondary|Major Adverse Cardiac Events|Composite of death, myocardial infarction or repeat revascularization|30 days and 6 months|||participants|||Number
655627|NCT01947335|Primary|Total Volume of Iodine Contrast Used During Procedure|Total volume of iodine contrast administered during the index procedure.|Day 1|||ml||Inter-Quartile Range|Median
655628|NCT01947153|Secondary|Linagliptin: AUC 0-tz (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point)|"Linagliptin:
AUC 0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)"|2 hours (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|PKS-L: includes all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint for linagliptin and had no important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints of linagliptin||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
655629|NCT01947153|Secondary|Metformin: AUC 0-inf (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity)|"Metformin:
AUC 0-inf (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)"|2 hours (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|PKS-M: includes all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint for metformin and had no important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints of metformin||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
655630|NCT01947153|Secondary|Linagliptin: AUC 0-inf (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity)|"Linagliptin:
AUC 0-inf (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)"|2 hours (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|PKS-L: includes all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint for linagliptin and had no important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints of linagliptin||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
655631|NCT01947153|Primary|Metformin: Cmax (Maximum Measured Concentration of the Analyte in Plasma)|"Metformin:
Cmax (maximum measured concentration of the analyte in plasma)"|2 hours (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|PKS-M: includes all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint for metformin and had no important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints of metformin||ng/mL||Geometric Coefficient of Variation|Geometric Mean
655632|NCT01947153|Primary|Linagliptin: Cmax (Maximum Measured Concentration of the Analyte in Plasma)|"Linagliptin:
Cmax (maximum measured concentration of the analyte in plasma)"|2 hours (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|PKS-L: includes all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint for linagliptin and had no important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints of linagliptin||nmol/L||Geometric Coefficient of Variation|Geometric Mean
655633|NCT01947153|Primary|Metformin: AUC0-tz (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point)|"Metformin:
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)"|2 hours (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|The subject set for the evaluation of pharmacokinetic endpoints of metformin (PKS-M): includes all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint for metformin and had no important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints of metformin||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
655634|NCT01947153|Primary|Linagliptin: AUC 0-72 (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to 72 Hours)|"Linagliptin:
AUC 0-72 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 72 hours)"|2 hours (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|subject set for the evaluation of pharmacokinetic endpoints of linagliptin (PKS-L): includes all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint for linagliptin and had no important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints of linagliptin||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
655635|NCT01947127|Secondary|Hospital Length of Stay|Numbers of days spent in the hospital since the emergency department arrival to hospital discharge|Patients will be followed for the duration of hospital stay, an expected average of 7 days|||Days||Inter-Quartile Range|Median
655636|NCT01947127|Secondary|All-cause Mortality Rates|Electronic database retrieval of in- and outpatient clinical records together with telephone follow-ups to the patients or their contact personnel are employed to every case in the next 30 days after the day of presentation to the emergency department to identify the deceased cases. All-cause mortality rates of each cohort will be compared by the survival analysis.|30 days after the day of presentation to the emergency department|Four patients out of 392 patients were excluded from secondary (mortality) outcome analysis due to unknown mortality status. As a result, 388 patients (139 in high lactate group and 249 in low lactate group) were available for mortality outcome analysis.||participants|||Number
655637|NCT01947127|Primary|Proportion of the Patients Who Require Vasopressor/Mechanical Ventilator|Proportion of the patients in each cohort who require vasopressor/mechanical ventilator to maintain their vital signs in the next 72 hours after venous lactate measurement.|72 hours after venous lactate measurement|||participants|||Number
655638|NCT01946542|Secondary|Vascular Function|flow-mediated dilation (FMD)|Testing Visit 1 (1-2 weeks from baseline) and Testing Visit 2 (2-3 weeks from baseline)|Given that only one participant completed each arm of the study, we are unable to report outcomes as group means. To report the individual demographic, clinical, and/or physiological characteristics of these participants would present significant and unnecessary risk of loss of confidentially. Thus, no outcome data is reported.|||||
655639|NCT01946542|Primary|Exercise Tolerance|treadmill time to exhaustion, cardiopulmonary exercise test|Testing Visit 1 (1-2 weeks from baseline) and Testing Visit 2 (2-3 weeks from baseline)|Given that only one participant completed each arm of the study, we are unable to report outcomes as group means. To report the individual demographic, clinical, and/or physiological characteristics of these participants would present significant and unnecessary risk of loss of confidentially. Thus, no outcome data is reported.|||||
655645|NCT01946438|Secondary|Geometric Mean Titer Ratios (GMTRs) of Antibodies to Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Following Vaccination With the Respective Vaccine|Influenza virus antibodies were measured using an HAI assay. Geometric mean titer ratios are the geometric means of the individual post-vaccination/pre-vaccination titer ratios for each hemagglutinin antigen contained in the vaccines.|Day 21 after vaccination|Geometric mean titer ratios against each hemagglutinin antigen were assessed in the Per-Protocol Analysis Set.||Titer Ratio||95% Confidence Interval|Geometric Mean
655646|NCT01946438|Secondary|Number of Participants Achieving Seroconversion Following Vaccination With the 2013-2014 Formulations of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine|Influenza virus antibodies were measured using an HAI assay. Seroconversion was defined as either a pre-vaccination HAI titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and a ≥ 4-fold increase in titer after vaccination.|Day 0 (pre-vaccination) and Day 21 after vaccination|Seroconversion against the hemagglutinin antigens contained in the vaccine were assessed in the Per-Protocol Analysis Set.||Participants|||Number
655647|NCT01946438|Secondary|Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine|Influenza virus antibodies were measured using an HAI assay. Seroprotection was defined as a titer of ≥40 (1/dilution).|Day 0 (pre-vaccination) and Day 21 after vaccination|Seroprotection against the hemagglutinin antigens were assessed in the Per-Protocol Analysis Set.||Participants|||Number
655648|NCT01946438|Secondary|Geometric Mean Titers (GMTs) of Antibodies to the Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Before and Following Vaccination With the Respective Vaccine|Influenza virus antibodies were measured using a hemagglutination inhibition (HAI) assay.|Day 0 (pre-vaccination) and Day 21 after vaccination|Geometric mean titers of antibodies against the hemagglutinin (HA) antigens were assessed in the Per-Protocol Analysis Set.||Titers||95% Confidence Interval|Geometric Mean
655649|NCT01946438|Primary|Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine.|Solicited injection-site reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3: Pain, Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis, >100 mm; Fever, ≥102.1°F; Headache, Malaise, Myalgia, and Shivering, Significant, prevents daily activity.|Day 0 up to Day 21 post-vaccination|Solicited injection-site reactions and systemic reactions were assessed using the Safety Analysis Set, which includes all persons who received at least one dose of study vaccine.||Participants|||Number
655650|NCT01946425|Primary|Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine|"Solicited injection-site reactions (6 months to <36 months of age): Tenderness, Erythema, and Swelling. Systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite loss, and Irritability. Grade 3: Tenderness, Cries if limb is moved; Erythema and Swelling, ≥50 mm; Fever, >103.1ºF; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, >3 hours; Drowsiness, Sleeping most of the time; Appetite lost, Refuses ≥3 feeds/meals or refuses most feeds/meals; Irritability, Inconsolable.
Solicited injection-site reactions (3 years to < 9 years of age): Pain, Erythema, and Swelling. Systemic Reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3: Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥50 mm; Fever, ≥102.1ºF; Headache, Malaise, and Myalgia, Significant, prevents daily activity."|Day 0 up to Day 7 post-vaccination|Solicited injection-site reactions and systemic reactions were assessed using the Safety Analysis Set, which includes all participants who received at least one dose of study vaccine.||Participants|||Number
655651|NCT01946425|Secondary|Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine|Influenza virus antibodies were measured using an HAI assay. Geometric mean titer ratios are the geometric means of the individual post-vaccination/pre-vaccination titer ratios for each hemagglutinin antigen contained in the vaccine.|Day 0 (pre-vaccination) and Day 28 after final vaccination|Geometric mean titer ratios against the hemagglutinin antigens were assessed in the Per-Protocol Analysis Set.||Titer Ratio||95% Confidence Interval|Geometric Mean
655652|NCT01946425|Secondary|Number of Participants Achieving Seroconversion Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine|Influenza virus antibodies were measured using an HAI assay. Seroconversion was defined as either a pre-vaccination HAI titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and a ≥ 4-fold increase in post-vaccination titer.|Day 0 (pre-vaccination) and Day 28 after final vaccination|Seroconversion against the hemagglutinin antigens were assessed in the Per-Protocol Analysis Set.||Participants|||Number
657374|NCT01923480|Secondary|Plasma Concentration of Glycine||Three times during each 7 hour visit|One subject completed Period 1, but withdrew from the study prior to the start of Period 2.||micromol/L||Standard Deviation|Mean
655653|NCT01946425|Secondary|Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine|Influenza virus antibodies were measured using an HAI assay. Seroprotection was defined as a titer ≥40 (1/dilution).|Day 0 (pre-vaccination) and Day 28 after final vaccination|Seroprotection against the hemagglutinin antigens were assessed in the Per-Protocol Analysis Set.||Participants|||Number
655654|NCT01946425|Secondary|Geometric Mean Titers (GMTs) of Influenza Antibodies Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine|Influenza virus antibodies were measured using a hemagglutination inhibition (HAI) assay.|Day 0 (pre-vaccination) and Day 28 after final vaccination|Geometric mean titers of antibodies against the hemagglutinin antigens were assessed in the Per-Protocol Analysis Set.||Titers||95% Confidence Interval|Geometric Mean
655655|NCT01946412|Secondary|Absolute Change From Baseline of Study 109 in Body Mass Index (BMI) at Week 12, 24, 36, 48, 60, 72 and 84|BMI = (Weight [in kg]) divided by (Stature [in meters]) ^2. Baseline is defined as the most recent measurement prior to intake of the first dose of study drug in study 109 (NCT01946412).|Baseline (study 109), Week 12, 24, 36, 48, 60, 72 and 84 (study 109)|Safety set. Here “n” signifies those participants who were evaluable at the specified time points for each arm, respectively. As per the planned analysis for this study, participants were to be analyzed based on their dosing groups as per parent study VX11-770-108 (NCT01705145).||kg/m^2||Standard Deviation|Mean
655656|NCT01946412|Secondary|Absolute Change From Baseline of Parent Study in Body Mass Index (BMI) at Week 12, 24, 36, 48, 60, 72 and 84|BMI = (Weight [in kg]) divided by (Stature [in meters]) ^2. Baseline was defined as the most recent measurement prior to intake of the first dose of study drug in study 108 Part B (NCT01705145).|Baseline (study 108), Week 12, 24, 36, 48, 60, 72 and 84 (study 109)|Safety set. Here “n” signifies those participants who were evaluable at the specified time points for each arm, respectively. As per the planned analysis for this study, participants were to be analyzed based on their dosing groups as per parent study VX11-770-108 (NCT01705145).||Kilogram per square meter (kg/m^2)||Standard Deviation|Mean
655657|NCT01946412|Secondary|Absolute Change From Baseline of Study 109 in Stature at Week 12, 24, 36, 48, 60, 72 and 84|Stature was measured as height if children could stand unassisted and follow directions; otherwise, stature was measured as length. Baseline is defined as the most recent measurement prior to intake of the first dose of study drug in study 109 (NCT01946412).|Baseline (study 109), Week 12, 24, 36, 48, 60, 72 and 84 (study 109)|Safety set. Here “n” signifies those participants who were evaluable at the specified time points for each arm, respectively. As per the planned analysis for this study, participants were to be analyzed based on their dosing groups as per parent study VX11-770-108 (NCT01705145).||cm||Standard Deviation|Mean
655658|NCT01946412|Secondary|Absolute Change From Baseline of Parent Study in Stature at Week 12, 24, 36, 48, 60, 72 and 84|Stature was measured as height if children could stand unassisted and follow directions; otherwise, stature was measured as length. Baseline was defined as the most recent measurement prior to intake of the first dose of study drug in study 108 Part B (NCT01705145).|Baseline (study 108), Week 12, 24, 36, 48, 60, 72 and 84 (study 109)|Safety set. Here “n” signifies those participants who were evaluable at the specified time points for each arm, respectively. As per the planned analysis for this study, participants were to be analyzed based on their dosing groups as per parent study VX11-770-108 (NCT01705145).||Centimeters (cm)||Standard Deviation|Mean
655659|NCT01946412|Secondary|Absolute Change From Baseline of Study 109 in Weight at Week 12, 24, 36, 48, 60, 72 and 84|Baseline is defined as the most recent measurement prior to intake of the first dose of study drug in study 109 (NCT01946412).|Baseline (study 109), Week 12, 24, 36, 48, 60, 72 and 84 (study 109)|Safety set. Here “n” signifies those participants who were evaluable at the specified time points for each arm, respectively. As per the planned analysis for this study, participants were to be analyzed based on their dosing groups as per parent study VX11-770-108 (NCT01705145).||Kg||Standard Deviation|Mean
655660|NCT01946412|Secondary|Absolute Change From Baseline of Parent Study in Weight at Week 12, 24, 36, 48, 60, 72 and 84|Baseline was defined as the most recent measurement prior to intake of the first dose of study drug in study 108 Part B (NCT01705145)|Baseline (study 108), Week 12, 24, 36, 48, 60, 72 and 84 (study 109)|Safety set. Here “n” signifies those participants who were evaluable at the specified time points for each arm, respectively. As per the planned analysis for this study, participants were to be analyzed based on their dosing groups as per parent study VX11-770-108 (NCT01705145).||kilogram (kg)||Standard Deviation|Mean
655661|NCT01946412|Secondary|Absolute Change From Baseline of Study 109 in Sweat Chloride at Week 24, 48, 72 and 84|Sweat samples were collected using an approved Macroduct (Wescor, Logan, Utah) collection device. A volume of >=15 microliter was required for determination of sweat chloride. Baseline is defined as the most recent measurement prior to intake of the first dose of study drug in study 109 (NCT01946412).|Baseline (study 109), Week 24, 48, 72 and 84 (study 109)|Safety set. Here “n” signifies those participants who were evaluable at the specified time points for each arm, respectively. As per the planned analysis for this study, participants were to be analyzed based on their dosing groups as per parent study VX11-770-108 (NCT01705145).||mmol/L||Standard Deviation|Mean
655662|NCT01946412|Secondary|Absolute Change From Baseline of Parent Study in Sweat Chloride at Week 24, 48, 72 and 84|Sweat samples were collected using an approved Macroduct (Wescor, Logan, Utah) collection device. A volume of greater than or equal to (>=) 15 microliter was required for determination of sweat chloride. Baseline was defined as the most recent measurement prior to intake of the first dose of study drug in study 108 Part B (NCT01705145).|Baseline (study 108), Week 24, 48, 72 and 84 (study 109)|Safety set. Here “n” signifies those participants who were evaluable at the specified time points for each arm, respectively.As per the planned analysis for this study, participants were to be analyzed based on their dosing groups as per parent study VX11-770-108 (NCT01705145).||millimole per liter (mmol/L)||Standard Deviation|Mean
655703|NCT01945294|Secondary|Percentage of Participants With Treatment-Related Serious AEs (SAEs)|A SAE is any AE that results in death, is life threatening, results in persistent or significant disability, results in or prolongs an existing inpatient hospitalization, is a congenital birth defect, is a cancer, is associated with an overdose, or is another important medical event.|Up to 60 weeks|The APaT includes all participants who received ≥1 dose of study drug.||Percentage of Participants|||Number
657375|NCT01923480|Secondary|Plasma Concentration of Glutamine||Three times during each 7 hour visit|One subject completed Period 1, but withdrew from the study prior to the start of Period 2.||micromol/L||Standard Deviation|Mean
655663|NCT01946412|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. AE includes serious as well as Non-serious AEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, Inpatient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. AEs with start date or increased severity on or after the first dose of study drug through the end of study participation was considered treatment-emergent.|Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)|Safety set included all participants who received at least 1 dose of study drug in study 109 (NCT01946412). As per the planned analysis for this study, participants were to be analyzed based on their dosing groups as per parent study VX11-770-108 (NCT01705145).||participants|||Number
655664|NCT01946243|Primary|Change in Total Accuracy (Siemens Syngo.PET Software, Experimental Arm Low Accuracy Readers)|Evaluate whether the addition of quantitation as an adjunct to qualitative interpretations (VisQ) significantly improved the total accuracy of Amyvid scan interpretation in lower accuracy readers. Only the 46 scans with autopsy from A07/A16 are used for this outcome measure.|Scan acquired 50-60 min post-injection|||Percent Accuracy||Standard Error|Mean
655665|NCT01946243|Secondary|Change in Reliability (Siemens Syngo.PET Software)|Evaluate whether VisQ interpretation significantly improved the reliability of Amyvid scan interpretation compared with qualitative scan interpretations alone. The scan interpretation reliability will be evaluated using Fleiss' Kappa statistics.|Scan acquired 50-60 min post-injection|||Fleiss Kappa||95% Confidence Interval|Number
655666|NCT01946243|Secondary|Change in Total Accuracy (Siemens Syngo.PET Software, Experimental Arm All Readers)|Evaluate whether the total accuracy of Amyvid VisQ interpretation was non-inferior to the qualitative scan interpretation alone. Only the 46 scans with autopsy from A07/A16 are used for this outcome measure.|Scan acquired 50-60 min post-injection|||Percent Accuracy||Standard Error|Mean
655667|NCT01946243|Secondary|Change in Reliability (MIMNeuro Software)|Evaluate whether VisQ interpretation significantly improved the reliability of Amyvid scan interpretation compared with qualitative scan interpretation alone. The scan interpretation reliability will be evaluated using Fleiss' Kappa statistics.|Scan acquired 50-60 min post-injection|||Fleiss Kappa||95% Confidence Interval|Number
655668|NCT01946243|Secondary|Change in Total Accuracy (MIMNeuro Software, All Readers)|Evaluate whether the total accuracy of Amyvid VisQ interpretation was non-inferior to the qualitative scan interpretation alone. Only the 46 scans with autopsy from A07/A16 are used for this outcome measure.|Scan acquired 50-60 min post-injection|||Percent Accuracy||Standard Error|Mean
655669|NCT01946243|Primary|Change in Total Accuracy (MIMNeuro Software, Low Accuracy Readers)|Evaluate whether the addition of quantitation as an adjunct to qualitative interpretations (VisQ) significantly improved the total accuracy of Amyvid scan interpretation in lower accuracy readers. Only the 46 scans with autopsy from A07/A16 are used for this outcome measure.|Scan acquired 50-60 min post-injection|||Percent Accuracy||Standard Error|Mean
655670|NCT01946178|Post-Hoc|Total Time Required to Deliver Treatment|The total treatment time was measured for each patient from the beginning of HIFU energy emission until HIFU energy emission stopped.|The total treatment time was measured on the day of treatment.|Total treatment times are reported for all treated patients. Total treatment times are stratified between two cohorts: an early Development Cohort and a final Validation Cohort.||minutes||Full Range|Mean
655671|NCT01946178|Secondary|HIFU-related Non-Perfused Volume (NPV)|Efficacy of the treatment was quantified by measuring the HIFU-related Non-Perfused Volume (NPV) of tissue in each patient using either post-treatment contrast-enhanced magnetic resonance imaging (MRI) or pathology assessment following hysterectomy. The NPV is used to measure the amount of tissue that was treated during the procedure.|The NPV was measured between 0 and 7 days post-treatment.|HIFU-related Non-Perfused Volumes (NPVs) are reported for all treated patients in whom they were observed following treatment. NPV outcomes are stratified between two cohorts: an early Development Cohort and a final Validation Cohort.||cubic centimeters (cc)||Full Range|Mean
655672|NCT01946178|Primary|Evaluation of All Adverse Events Encountered|Safety of the treatment was determined by evaluating the incidence of Adverse Events and Adverse Device Effects. Adverse Device Effects are Adverse Events that are related to treatment with the device. Relatedness of an Adverse Event to the treatment was determined on a case-by-case basis by the investigator. The average number of Serious Adverse Device Effects per patient and the average number of Non-Serious Adverse Device Effects per patient are reported to provide numeric outcomes of this evaluation.|Adverse Events were monitored until the patient's exit from the study (up to 6 months post-treatment).|All Adverse Device Effects are reported for the entire study population (all treated patients).||Adverse Device Effects / patient||Full Range|Mean
655673|NCT01946126|Secondary|Number of Visits for Headache Diagnosis|The number of visits for headache diagnosis is evaluated through the study period.|15 Months|All enrolled subjects||Visits||Standard Deviation|Mean
655674|NCT01946126|Secondary|Highest Number of Headache Days Per Month at a Qualifying Visit|The highest number of headache days per month are reported at a qualifying visit per the medical record.|15 Months|All enrolled subjects with data for this outcome measure||Days||95% Confidence Interval|Mean
655675|NCT01946126|Secondary|Number of Days With a Headache Recorded at the Visit With the Highest Number of Headaches|The number of headache days is reported at the visit with the highest number of headaches.|15 Months|All enrolled subjects||Headache Days||95% Confidence Interval|Mean
655676|NCT01946126|Secondary|Number of Unique Prophylactic Medications for Headache/Migraine Reported|The numbers of unique prophylactic medications used by the subjects for headache/migraine are evaluated through the study period.|15 Months|All enrolled subjects||Medications||Standard Deviation|Mean
655677|NCT01946126|Primary|Presence or Absence of Prophylactic Medication for Headache/Migraine|The presence or absence of prophylactic medications used by the subject for headache/migraine is evaluated through the study period.|15 Months|All enrolled subjects||Participants|||Number
679608|NCT01581437|Primary|Percentage of Patients With Greater Than One Right Atrial Source of Rotor/Focal Sources|percentage of patients|30 minutes|||percentage of patients|||Number
655678|NCT01945970|Other Pre-specified|Endothelium Independent Dilation, Acute, Positive Control|"Flow mediated dilation (FMD) measurement included the following steps:
1 minute base scan to measure the baseline diameter of artery (Resting stage)
5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease)
4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage)
When the artery had returned to baseline a second 1 minute scan was taken
25 µg sublingual glyceryl trinitrate (GTN) was given to the subject
5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation)."|From before consumption on day 1 to 2 hours post consumption on day 1|||percentage of vascular dilation||Standard Deviation|Mean
655679|NCT01945970|Other Pre-specified|Endothelium Independent Dilation, Chronic, Positive Control|"Flow mediated dilation (FMD) measurement included the following steps:
1 minute base scan to measure the baseline diameter of artery (Resting stage)
5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease)
4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage)
When the artery had returned to baseline a second 1 minute scan was taken
25 µg sublingual glyceryl trinitrate (GTN) was given to the subject
5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation)."|From before consumption on day 1 to before consumption day 8|Intention to treat||percentage of vascular dilation||Standard Deviation|Mean
655680|NCT01945970|Other Pre-specified|Endothelium Independent Dilation, Acute-upon-chronic, Positive Control|"Flow mediated dilation (FMD) measurement included the following steps:
1 minute base scan to measure the baseline diameter of artery (Resting stage)
5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease)
4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage)
When the artery had returned to baseline a second 1 minute scan was taken
25 µg sublingual glyceryl trinitrate (GTN) was given to the subject
5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation)."|From before consumption on day 1 to 2 hours post consumption on day 8|||percentage of vascular dilation||Standard Deviation|Mean
655681|NCT01945970|Other Pre-specified|Endothelium-Independent Dilation, Acute, Black Tea|"Flow mediated dilation (FMD) measurement included the following steps:
1 minute base scan to measure the baseline diameter of artery (Resting stage)
5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease)
4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage)
When the artery had returned to baseline a second 1 minute scan was taken
25 µg sublingual glyceryl trinitrate (GTN) was given to the subject
5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation)."|From before consumption on day 1 to 2 hours post consumption on day 1|||percentage of vascular dilation||Standard Deviation|Mean
655682|NCT01945970|Other Pre-specified|Endothelium Independent Dilation, Chronic, Black Tea|"Flow mediated dilation (FMD) measurement included the following steps:
1 minute base scan to measure the baseline diameter of artery (Resting stage)
5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease)
4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage)
When the artery had returned to baseline a second 1 minute scan was taken
25 µg sublingual glyceryl trinitrate (GTN) was given to the subject
5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation)."|From before consumption on day 1 to before consumption day 8|Intention to treat||percentage of vascular dilation||Standard Deviation|Mean
655683|NCT01945970|Other Pre-specified|Endothelium Independent Dilation, Acute-upon-chronic, Black Tea|"FMD measurement included the following steps:
1 minute base scan to measure the baseline diameter of artery (Resting stage)
5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease)
4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage)
When the artery had returned to baseline a second 1 minute scan was taken
25 µg sublingual glyceryl trinitrate (GTN) was given to the subject
5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation)."|From before consumption on day 1 to 2 hours post consumption on day 8|Intention to treat||percentage of vascular dilation||Standard Deviation|Mean
655684|NCT01945970|Other Pre-specified|Diastolic Blood Pressure, Positive Control|Change in Diastolic Blood pressure|From before consumption on day 1 to before consumption day 8|||mmHg||Standard Deviation|Mean
655685|NCT01945970|Other Pre-specified|Systolic Blood Pressure, Positive Control|Change in systolic blood pressure|From before consumption (baseline) day 1 to before consumption day 8|Intention to treat||mmHg||Standard Deviation|Mean
655686|NCT01945970|Other Pre-specified|Diastolic Blood Pressure Black Tea|Change in Diastolic blood pressure|From before consumption on day 1 to before consumption day 8|||mmHg||Standard Deviation|Mean
655687|NCT01945970|Other Pre-specified|Systolic Blood Pressure, Black Tea|Change in Systolic blood pressure|From before consumption on day 1 to before consumption on day 8|||mmHg||Standard Deviation|Mean
655688|NCT01945970|Secondary|Flow Mediated Dilation, Chronic, Positive Control|"Flow mediated dilation (FMD) measurement included the following steps:
1 minute base scan to measure the baseline diameter of artery (Resting stage)
5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease)
4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage)
When the artery had returned to baseline a second 1 minute scan was taken
25 µg sublingual glyceryl trinitrate (GTN) was given to the subject
5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation)."|From before consumption on day 1 to before consumption day 8|Intention to treat||percentage of flow mediated dilation||Standard Deviation|Mean
655689|NCT01945970|Secondary|Flow Mediated Dilation, Acute, Positive Control|"Flow mediated dilation (FMD) measurement included the following steps:
1 minute base scan to measure the baseline diameter of artery (Resting stage)
5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease)
4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage)
When the artery had returned to baseline a second 1 minute scan was taken
25 µg sublingual glyceryl trinitrate (GTN) was given to the subject
5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation)."|From before consumption on day 1 to 2 hours post consumption on day 1|Intention to treat||percentage of flow mediated dilation||Standard Deviation|Mean
655690|NCT01945970|Secondary|Flow Mediated Dilation, Acute-upon-chronic, Positive Control|"Flow mediated dilation (FMD) measurement included the following steps:
1 minute base scan to measure the baseline diameter of artery (Resting stage)
5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease)
4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage)
When the artery had returned to baseline a second 1 minute scan was taken
25 µg sublingual glyceryl trinitrate (GTN) was given to the subject
5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation)."|From before consumption on day 1 to 2 hours post consumption on day 8|Intention to treat||percentage of flow mediated dilation||Standard Deviation|Least Squares Mean
655691|NCT01945970|Secondary|Flow Mediated Dilation, Chronic, Black Tea|"Flow mediated dilation (FMD) measurement included the following steps:
1 minute base scan to measure the baseline diameter of artery (Resting stage)
5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease)
4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage)
When the artery had returned to baseline a second 1 minute scan was taken
25 µg sublingual glyceryl trinitrate (GTN) was given to the subject
5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation)."|From before consumption day 1 to before consumption day 8.|||percentage of flow mediated dilation||Standard Deviation|Least Squares Mean
655692|NCT01945970|Secondary|Flow Mediated Dilation, Acute, Black Tea|"Flow mediated dilation (FMD) measurement included the following steps:
1 minute base scan to measure the baseline diameter of artery (Resting stage)
5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease)
4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage)
When the artery had returned to baseline a second 1 minute scan was taken
25 µg sublingual glyceryl trinitrate (GTN) was given to the subject
5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation)."|From before consumption on day 1 to 2 hours post consumption on day 1|Intention to treat||percentage of flow mediated dilation||Standard Deviation|Least Squares Mean
655693|NCT01945970|Primary|Flow Mediated Dilation, Acute-upon-chronic, Black Tea|"Flow mediated dilation (FMD) measurement included the following steps:
1 minute base scan to measure the baseline diameter of artery (Resting stage)
5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease)
4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage)
When the artery had returned to baseline a second 1 minute scan was taken
25 µg sublingual glyceryl trinitrate (GTN) was given to the subject
5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation)."|From before consumption on day 1 to 2 hours post consumption on day 8.|Intention to treat||percentage of flow mediated dilation||Standard Deviation|Least Squares Mean
655694|NCT01945944|Secondary|Dead Space|in % of tidal volume, using parameters on mechanical ventilator. Dead space is a measure of how much of the lung is not able to move air into and out of the body. Higher levels of dead space reflect higher levels of lung dysfunction.|during mechanical ventilation (typically 4 days - 2 weeks)|||percentage of lung volume||Inter-Quartile Range|Median
655695|NCT01945944|Secondary|Oxygenation|SaO2/FiO2. This is a measure of how will the lungs are providing oxygen to the body. Higher ratios reflect better lung function.|during mechanical ventilation (typically 4 days - 2 weeks)|||ratio||Inter-Quartile Range|Median
655696|NCT01945944|Secondary|Dynamic Compliance|measured in ml/cm H20/kg using parameters on mechanical ventilator|during mechanical ventilation (typically 4 days - 2 weeks)|||mL/kg/cm-H20||Inter-Quartile Range|Median
655697|NCT01945944|Secondary|Change in Serum Sodium From Baseline|The baseline sodium was the last level measured prior to study initiation, typically within 24hrs of study initiation. The change in blood sodium level was calculated as the difference between the mean post-enrollment sodium level during ICU care and the sodium level at enrollment.|during hospitalization (typically 4 days - 2 weeks)|||mEq/L||Inter-Quartile Range|Median
655698|NCT01945944|Secondary|Hospital Length of Stay||during hospitalization (typically 4 days - 2 weeks)|||days||Inter-Quartile Range|Median
655699|NCT01945944|Secondary|ICU Length of Stay||during hospitalization (typically 4 days - 2 weeks)|||days||Inter-Quartile Range|Median
655700|NCT01945944|Secondary|Wheezing|as dichotomous outcome (yes/no) following drug administration|during mechanical ventilation (typically 4 days - 2 weeks)|||percentage of drug doses w/ wheezing|||Number
655701|NCT01945944|Secondary|Atelectasis|"using chest x ray score. The score measures the amount of lung collapse (atelectasis) observed on a chest x-ray. For each of the 5 lung lobes, 1 point is given for linear atelectasis, 2 points for sub-segmental atelectasis and 3 points for lobar atelectasis. The range is 0-15 points, with higher scores reflecting more severe lung collapse."|during mechanical ventilation (typically 4 days - 2 weeks)|||units on a scale||Inter-Quartile Range|Median
655702|NCT01945944|Primary|Duration of Mechanical Ventilation||typically 4 days - 2 weeks|||hours||Inter-Quartile Range|Median
657376|NCT01923480|Secondary|Plasma Concentration of Glutamic Acid||Three times during each 7 hour visit|One subject completed Period 1, but withdrew from the study prior to the start of Period 2.||micromol/L||Standard Deviation|Mean
655704|NCT01945294|Secondary|Percentage of Participants With Dose Discontinuation Due to Adverse Events (AEs)|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. The percentage of participants who discontinued from BOC, BOC + RBV, or all medications due to an AE are reported.|From TW1 through TW48|The APaT includes all participants who received ≥1 dose of study drug.||Percentage of Participants|||Number
655705|NCT01945294|Secondary|Percentage of Participants With Anemia|The percentage of participants with anemia (hemoglobin [Hgb] <10 g/dL) was determined in each arm.|Up to 60 weeks|The All Participants as Treated (APaT) includes all participants who received ≥1 dose of study drug.||Percentage of Participants|||Number
655706|NCT01945294|Secondary|Percentage of Participants With Neutropenia|The percentage of participants with neutropenia (neutrophil count <0.75 x10^9/L) is summarized for each arm.|Up to 60 weeks|The All Participants as Treated (APaT) includes all participants who received ≥1 dose of study drug.||Percentage of Participants|||Number
655707|NCT01945294|Secondary|Percentage of Participants With Relapse|The percentage of viral relapse (defined as confirmed HCV RNA >15 IU/mL after End-of-Treatment [EOT]) among participants who had undetectable HCV RNA at EOT was determined for each arm. The Roche COBAS™ Taqman™ automated HCV test (v2.0 assay) used in this study has a LLoQ of 15 IU/mL.|From EOT to FW12 (up to 12 weeks)|Participants in the FAS with undetectable HCV RNA at EOT and who have data available at FW12 were included.||Percentage of Participants|||Number
655708|NCT01945294|Secondary|Percentage of Participants Achieving SVR12 Among Participants With Undetectable HCV RNA Across Treatment|The percentage of participants achieving SVR12 who had undetectable HCV RNA (HCV RNA <LLoQ) at Week 4, Week 8, and Week 12 is summarized for each arm. The Roche COBAS™ Taqman™ automated HCV test (v2.0 assay) used in this study has a LLoQ of 15 IU/mL.|TW4, TW8, and TW12|The subset of the FAS population consisting of all participants treated with any study medication in Arms 1, 2, and 3 and who had undetectable HCV RNA at Week 4, Week 8, or Week 12.||Percentage of Participants|||Number
655709|NCT01945294|Secondary|Percentage of Participants With Undetectable HCV RNA Across Treatment|The percentage of participants with undetectable HCV RNA (HCV RNA <LLoQ) at TW4, TW8, and TW12 is summarized for each arm. The Roche COBAS™ Taqman™ automated HCV test (v2.0 assay) used in this study has a LLoQ of 15 IU/mL.|TW4, TW8, and TW12|Participants in the FAS population (consisting of all participants treated with any study medication who had undetectable HCV RNA at TW8 and were randomized to Arm 1 or Arm 2, and participants with detectable HCV RNA at TW8 in Arm 3) with available data.||Percentage of Participants|||Number
655710|NCT01945294|Primary|Percentage of Participants With Undetectable HCV RNA Who Achieve Sustained Viral Response at Follow-up Week 12 (SVR12) [16-Week Arm vs. 28-Week Arm]|SVR12 was declared when participants who had undetectable HCV RNA (HCV RNA < Lower Limit of Quantification [LLoQ]) after the 12-week lead-in also had undetectable HCV RNA 12 weeks after completing their assigned BOC treatment regimen. The Roche COBAS™ Taqman™ automated HCV test (v2.0 assay) used in this study has a LLoQ of 15 IU/mL.|Follow-up Week (FW) 12 (up to 40 weeks)|Participants of the Full Analysis Set (FAS) who were treated with any study medication, had undetectable HCV RNA at TW8, and were randomized to Arm 1 or Arm 2. Participants in Arm 3 were not included in the primary efficacy analysis as pre-specified by the protocol.||Percentage of Participants|||Number
655711|NCT01945242|Secondary|Change From Baseline in Fasting Insulin|The change between the fasting insulin value collected at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of the thiazolidinedione treatment.|Baseline, Months 1, 3, 6, 12, and final assessment (up to 12 months)|The efficacy assessment population was defined as participants who completed the study and had available efficacy data at baseline and post baseline.||mg/dL||Standard Deviation|Mean
655712|NCT01945242|Secondary|Change From Baseline in Fasting Blood Glucose|The change between the fasting blood glucose value collected at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of the thiazolidinedione treatment.|Baseline, Months 1, 3, 6, 12, and final assessment (up to 12 months)|The efficacy assessment population was defined as participants who completed the study and had available efficacy data at baseline and post baseline.||milligram per deciliter (mg/dL)||Standard Deviation|Mean
655713|NCT01945242|Secondary|Percentage of Participants of Achieving Objective Glycemic Control|The rate of achieving objective glycemic control in HbA1c level, was calculated at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12). Glycemic control was measured as <8.0 percent, <7.0 percent, and <6.0 percent of glycosylated hemoglobin. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of the thiazolidinedione treatment.|Baseline, Months 1, 3, 6, 12, and final assessment (up to 12 months)|The efficacy assessment population was defined as participants who completed the study and had available efficacy data at baseline and post baseline.||percentage of participants|||Number
655714|NCT01945242|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of the thiazolidinedione treatment.|Baseline, Months 1, 3, 6, 12, and final assessment (up to 12 months)|The efficacy assessment population was defined as participants who completed the study and had available efficacy data at baseline and post baseline.||percentage of glycosylated hemoglobin||Standard Deviation|Mean
655715|NCT01945242|Primary|Number of Participants Reporting One or More Serious Adverse Drug Reactions|Serious adverse drug reactions are defined as serious adverse events (SAEs) which are in the investigator’s opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The safety analysis was planned to be assessed in alogliptin + thiazolidinedione and alogliptin + other arm separately.|Baseline up to 12 months|The safety analysis set was defined as all participants who were enrolled and completed the study.||participants|||Number
655716|NCT01945242|Primary|Number of Participants Reporting One or More Adverse Drug Reactions|Adverse drug reactions are defined as adverse events (AEs) which are in the investigator’s opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. The safety analysis was planned to be assessed in alogliptin + thiazolidinedione and alogliptin + other arm separately.|Baseline up to 12 months|The safety analysis set was defined as all participants who were enrolled and completed the study.||participants|||Number
655717|NCT01945138|Secondary|Day 28 Follow-Up: C-Peptide||Day 28 Follow-Up|||ng/mL||Standard Deviation|Mean
655718|NCT01945138|Secondary|Day 28 Follow-Up: Average Serum BG||Day 28 Follow-Up|||mg/dL||Standard Deviation|Mean
655719|NCT01945138|Secondary|Day 14 Follow-Up: C-Peptide||Day 14 Follow-Up:|||ng/mL||Standard Deviation|Mean
655720|NCT01945138|Secondary|Day 14 Follow-Up: Average Serum BG||Day 14 Follow-Up|||mg/dL||Standard Deviation|Mean
655721|NCT01945138|Secondary|Study Period: Daily Insulin Needs|Calculated as total daily dose of insulin.|Average of 3 day study period|||U/kg/day||Standard Deviation|Mean
655722|NCT01945138|Secondary|Study Period: Morning C-peptide|A single C-peptide measurement collected daily x 3 days, collected at random (meaning not in a fasting state) each morning. Expressed as average for each patient.|Average of 3 day study period|||ng/mL||Standard Deviation|Mean
655723|NCT01945138|Secondary|Study Period: % of Time CGM BG > 140 mg/dL||continuous over the 72 hour investigation period|||% of time||95% Confidence Interval|Mean
655724|NCT01945138|Secondary|Study Period: CGM AUC With Glucose> 140 mg/dL||continuous over the 72 hour investigation period|||min*mg/dL/day||Standard Deviation|Mean
655725|NCT01945138|Secondary|Study Period: % of Time CGM BG <70 mg/dL||continuous over the 72 hour investigation period|||% of time||95% Confidence Interval|Mean
655726|NCT01945138|Secondary|Study Period: CGM Area Under the Curve (AUC) With Glucose < 70 mg/dL|Calculated as the area under the curve on the CGM tracing that the glucose is under 70 mg/dL.|continuous over the 72 hour investigation period|||min*mg/dL/day||Standard Deviation|Mean
655727|NCT01945138|Secondary|Study Period: Percent Time BG in Range 70-140 mg/dL|Additional measure of glycemic variability, as reflected by CGM measures, % time in the range of 70-140 on CGM|continuous over the 72 hour investigation period|||% of time||95% Confidence Interval|Mean
655728|NCT01945138|Secondary|Study Period: Continuous Glucose Monitor Standard Deviation of BG|measure of glycemic variability by CGM. This is the standard deviation within each patient for all CGM glucose readings.|continuous over the 72 hour investigation period|||mg/dL||Standard Deviation|Mean
655729|NCT01945138|Secondary|Study Period: Continuous Glucose Monitor (CGM) BG Average|Continuous glucose monitoring sensor data: The CGM's in the pump and control groups will collect glucose readings continuously over a 72 hour period|continuously over the 72 hour investigational period|||mg/dL||Standard Deviation|Mean
655730|NCT01945138|Primary|Study Period: Serum BG Standard Deviation|Measure of glycemic variability. This is the standard deviation in all serum BG values for each individual patient.|3 days of investigation period|||mg/dL||Standard Deviation|Mean
655731|NCT01945138|Primary|Study Period: Average Serum BG|Mean blood glucose value: a single report of the average of the analytical blood glucose values will be computed and compared between the pump and control groups.|3 days of investigation period|||mg/dL||Standard Deviation|Mean
655732|NCT01945112|Primary|Count of Participants With Any Foot Blister in Taped or Untaped Area of the Foot|Blister data were collected without regard to whether the foot was right or left.|within 7 days of application of tape|||Participants|||Count of Participants
655733|NCT01945086|Secondary|Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD)|The EASI score was used to measure the severity and extent of AD and measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on a scale of 0 to 3 where 0=none, 1=mild, 2=moderate, 3=severe, on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no eruption) to 6 (greater than [>] 90%-100% eruption). The total score is the sum of the four body-region scores, maximum=72, minimum=0, with higher scores reflecting greater disease severity. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score.|Baseline, Week 2, 4, 8, 12, 16, 20 and 24|FAS population was used for analysis. ‘N’ (Number of Participants Analyzed) signifies number of participants who were evaluable for this outcome measure. ‘n’ signifies number of participants who were evaluable at each specific time point for each arm respectively.||participants|||Number
655734|NCT01945086|Secondary|Percent Change From Baseline of Body Region Scores in EASI|The EASI score was used to measure the severity and extent of AD and measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no eruption) to 6 (greater than [>] 90%-100% eruption). The total score is the sum of the four body-region scores, maximum=72, minimum=0, with higher scores reflecting greater disease severity. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score.|Week 2, 4, 8, 12, 16, 20 and 24|FAS population was used for analysis. ‘N’ (Number of Participants Analyzed) signifies number of participants who were evaluable for this outcome measure. ‘n’ signifies number of participants who were evaluable at each specific time point for each arm respectively.||percent change||Standard Deviation|Mean
655750|NCT01945034|Secondary|Change From Baseline in Participant Assessment of Normal Function and Activity at Day 3 and 10|Participant assessment of normal function was measured using a 5-point scale: 1= Normal walking/activity and no pain; 2= Normal walking/activity with pain; 3= Mildly restricted walking due to pain and can’t resume normal activities; 4= Moderately restricted walking due to pain and can’t resume normal activities; 5= Severely restricted walking due to pain and can’t resume normal activities. The normal functioning and activity scores for each question range from 1 to 5, with higher scores indicating worsening of normal activity.|Baseline, Day 3, 10|The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.||Units on a scale||Standard Error|Least Squares Mean
682443|NCT01541865|Secondary|Renal Artery Dissection or Perforation During the Procedure That Requires Stenting or Surgery||Duration of the procedure (average of 65 minutes)|||participants|||Number
655735|NCT01945086|Secondary|Percent Change From Baseline in EASI Sign of Disease Components|The EASI score was used to measure the severity and extent of AD and measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no eruption) to 6 (greater than [>] 90%-100% eruption). The total score is the sum of the four body-region scores, maximum=72, minimum=0, with higher scores reflecting greater disease severity. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score.|Week 2, 4, 8, 12, 16, 20 and 24|FAS population was used for analysis. ‘N’ (Number of Participants Analyzed) signifies number of participants who were evaluable for this outcome measure. ‘n’ signifies number of participants who were evaluable at each specific time point for each arm respectively.||percent change||Standard Deviation|Mean
655736|NCT01945086|Secondary|Percent Change From Baseline in EASI Total Score|The EASI score was used to measure the severity and extent of AD and measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no eruption) to 6 (greater than [>] 90%-100% eruption). The total score is the sum of the four body-region scores, maximum=72, minimum=0, with higher scores reflecting greater disease severity. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score.|Week 2, 4, 8, 12, 16, 20 and 24|FAS population was used for analysis. ‘N’ (Number of Participants Analyzed) signifies number of participants who were evaluable for this outcome measure. ‘n’ signifies number of participants who were evaluable at each specific time point for each arm respectively. LOCF method was not applied to impute the missing data.||percent change||Standard Deviation|Mean
655737|NCT01945086|Secondary|Number of Participants in IGA|The IGA utilizes a 6-point scale ranging from 0 (clear) to 5 (very severe disease) where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe and 5 (very severe disease).|Baseline, Week 2, 4, 8, 12, 16, 20 and 24|FAS population was used for analysis. ‘N’ (Number of Participants Analyzed) signifies number of participants who were evaluable for this outcome measure. ‘n’ signifies number of participants who were evaluable at each specific time point for each arm respectively.||participants|||Number
655738|NCT01945086|Secondary|Number of Participants With Greater Than or Equal to 2 Points Decrease in IGA From Baseline|The IGA utilizes a 6-point scale ranging from 0 (clear) to 5 (very severe disease) where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe and 5 (very severe disease).|Week 2, 4, 8, 12, 16, 20 and 24|FAS population was used for analysis. ‘N’ (Number of Participants Analyzed) signifies number of participants who were evaluable for this outcome measure. ‘n’ signifies number of participants who were evaluable at each specific time point for each arm respectively.||participants|||Number
655739|NCT01945086|Secondary|Number of Participants With an IGA Score of “Clear” or “Almost Clear”|The IGA utilizes a 6-point scale ranging from 0 (clear) to 5 (very severe disease) where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe and 5 (very severe disease).|Baseline, Week 2, 4, 8, 12, 16, 20 and 24|FAS population was used for analysis. ‘N’ (Number of Participants Analyzed) signifies number of participants who were evaluable for this outcome measure. ‘n’ signifies number of participants who were evaluable at each specific time point for each arm respectively.||participants|||Number
655740|NCT01945086|Secondary|Number of Participants With Greater Than or Equal to (>=) 50 Percent (%) and >=75% Decrease in EASI Total Score From Baseline|The EASI score was used to measure the severity and extent of AD and measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no eruption) to 6 (greater than [>] 90%-100% eruption). The total score is the sum of the four body-region scores, maximum=72, minimum=0, with higher scores reflecting greater disease severity. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score.|Week 2, 4, 8, 12, 16, 20 and 24|FAS population was used for analysis. ‘N’ (Number of Participants Analyzed) signifies number of participants who were evaluable for this outcome measure. ‘n’ signifies number of participants who were evaluable at each specific time point for each arm respectively.||participants|||Number
655741|NCT01945086|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 12|The DLQI is a dermatology-specific quality of life (QOL) instrument designed to assess impact of disease on a participants QOL. It is a 10-item questionnaire that, in addition to evaluating overall, QOL can be used to assess 6 different aspects: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships and treatment. Questions scored on a 4-point Likert scale: 0 (not relevant), 1 (a little), 2 (a lot), and 3 (very much). Scores of individual items (0-3) were added to yield a total score (0-30); higher score = greater impairment of participants QOL.|Baseline and Week 12|FAS included all randomized participants with at least 1 study agent administration irrespective of whether the participant received the assigned treatment, and had at least 1 postdose EASI assessment. LOCF method was used to impute the missing data.||units on a scale||Standard Deviation|Mean
655751|NCT01945034|Secondary|Sum of Pain Intensity Difference Scores at Rest and on Weight Bearing Over 7 Days|PI was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted sum of PID scores over 7 days (168 hours). Total score ranges from -840 (higher pain relief) to 1008 (lower pain relief). SPID is a value of change from baseline. Pain score at baseline is usually higher than that at post baseline. So negative value of SPID indicates pain relief from baseline, while positive value means a worst pain comparing to baseline, a negative value of SPID indicates higher pain relief from baseline.|Over 7 days (0-168 hours)|The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.||Units on a scale||Standard Error|Least Squares Mean
655935|NCT01942148|Secondary|Mean Change From Baseline at Final Assessment in Children's Global Assessment Score (CGAS)|The Children's Global Assessment Score (CGAS) is a rating scale which measures psychological, social and school functioning for children aged 6-17. Scores range from 0 to 100, with higher scores indicating better condition.|Baseline and Week52|||units on a scale||Standard Deviation|Mean
655742|NCT01945086|Secondary|Change From Baseline in Atopic Dermatitis Itch Scale (ADIS) at Week 12|The atopic dermatitis itch scale (ADIS) will be used to assess pruritus (itching) among participants with AD. It will be evaluated by participant diary kept twice daily,in the morning(morning daily score[MDS]) and evening (Evening Daily Score[EDS]). The start-of-day item set consists of 4 items:itching at time of completing morning diary(Q1),presence of itching during night before(Q2), itching at its worst at night (Q3), and impact of itching on sleep at night(Q4). Appropriate items are summed to yield total score ranging from 0=minimum to 23=maximum, with higher scores reflecting greater itching. The end-of day item set also consists of 4 items: itching at time of completing the evening diary(Q1),the presence of itching during the day(Q2),itching at its worst during the day(Q3),and amount of time the participant experienced eczema-related itching(Q4). Appropriate items are summed to yield total score ranging from 0=minimum to 24=maximum,with higher scores reflecting greater itching.|Baseline and Week 12|FAS population was used for analysis. LOCF method was used to impute the missing data. ‘N’ (Number of Participants Analyzed) signifies number of participants who were evaluable for this outcome measure. ‘n’ signifies number of participants who were evaluable at each specific time point for each arm respectively.||units on a scale||Standard Deviation|Mean
655743|NCT01945086|Secondary|"Number of Participants With an Investigator's Global Assessment (IGA) Score of Clear or Almost Clear at Week 12"|The IGA utilizes a 6-point scale ranging from 0 (clear) to 5 (very severe disease) where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe and 5 (very severe disease).|Week 12|FAS included all randomized participants with at least 1 study agent administration irrespective of whether the participant received the assigned treatment, and had at least 1 postdose EASI assessment. LOCF method was used to impute the missing data.||participants|||Number
655744|NCT01945086|Primary|Percent Change in Eczema Area Severity Index (EASI) Total Score From Baseline at Week 12|The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no eruption) to 6 (greater than [>] 90 percent [%]-100% eruption). The total score is the sum of the four body-region scores, maximum=72, minimum=0, with higher scores reflecting greater disease severity. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score.|Baseline and Week 12|Full Analysis Set (FAS) included all randomized participants with at least 1 study agent administration irrespective of whether the participant received the assigned treatment, and had at least 1 postdose EASI assessment. Last Observation Carried Forward (LOCF) method was used to impute the missing data.||percent change||Standard Deviation|Mean
655745|NCT01945034|Secondary|Percentage of Participants Taking Rescue Medication|Participants used only acetaminophen at a dose of 500 mg every 6 hours PRN as analgesia or rescue therapy during the course of the study. Participants who used acetaminophen were to record its use, and date and time of administration in the participant diary.|Post first dose Day 1 up to Day 10|The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.||Percentage of participants|||Number
655746|NCT01945034|Secondary|Number of Doses of Rescue Medication Used During the First 7 Days of Dosing|Participants received only acetaminophen 500 mg every 6 hours PRN as rescue medication during the course of the study.|Baseline up to Day 7|The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.||Doses||Standard Deviation|Mean
655747|NCT01945034|Secondary|Time to Rescue Medication After Initial Dose, and After Each Subsequent Dose|Participants used only acetaminophen at a dose of 500 milligram (mg) every 6 hours product as needed (PRN) as rescue medication during the course of the study. Participants who used acetaminophen were to record its use, and date and time of administration in the participant diary. Time to rescue medication after initial dose, after each subsequent dose, provided that in each dose interval at least 25% of the participants take rescue medication was analyzed using the proportional hazard model with site, treatment group, and baseline categorical ankle pain terms in the model.|Post-Dose on Day 1 up to Day 10|Data was not analyzed since <20% participants used rescue medication.|||||
655748|NCT01945034|Secondary|Time to First Perceptible Relief and Meaningful Relief|"Participants evaluated time to first perceptible relief by stopping a stopwatch labelled 'first perceptible relief' at moment participant first began to experience any relief, exact question asked was: “Stop stopwatch when you first begin to feel any pain-relieving effect whatsoever of product; that is, when you first feel a little relief”. First perceptible relief was considered confirmed by meaningful relief if participant achieved both first perceptible and meaningful relief by either pressing second stopwatch or by indicating that his/her first perceptible relief was also meaningful. For “time to meaningful relief,” exact question asked was: “Stop this stopwatch when you have meaningful relief; that is, when relief from pain is meaningful to you.” Stopwatches were active up to 3 hours after dosing or until stopped by participant, or rescue medication was administered."|0 to 3 hours on Day 1|The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.||Minutes||95% Confidence Interval|Median
655749|NCT01945034|Secondary|Participant’s Global Assessment of Medication at End of Study|Participants Global Assessment of Medication was used to rate the medication as a pain reliever. The responses of participants were recorded using 5-point scale: 1= Very Poor, 2= Poor, 3= Fair, 4= Good, 5= Very Good. The global assessment of medication scores for each question range from 0 to 5, giving a possible score range of 0 - 5, with higher scores indicating medication as a better pain reliever.|Day 10|The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment. Number of participants analyzed 'N' signifies those participants who were evaluable for the measure.||Units on a scale||Standard Deviation|Mean
655752|NCT01945034|Secondary|Sum of Pain Intensity Difference Scores at Rest Over 3 Days|PI was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted sum of PID scores over 3 days (72 hours). Total score ranges from -360 (higher pain relief) to 432 (lower pain relief). SPID is a value of change from baseline. Pain score at base line is usually higher than that at post baseline. So negative value of SPID indicates pain relief from baseline, while positive value means a worst pain comparing to baseline, a negative value of SPID indicates higher pain relief from baseline.|Over 3 Days (0-72 hours)|The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.||Units on a scale||Standard Error|Least Squares Mean
655753|NCT01945034|Secondary|Sum of Pain Intensity Difference at Rest and on Weight Bearing Over 6 Hours on Day 1 and Over 2 Hours on Day 3|PI at rest and on weight bearing was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID 0-6 was calculated as the time-weighted sum of PID scores over 6 hours on Day 1, with a total score ranges from -30 (higher pain relief) to 36 (lower pain relief). SPID 0-12 was calculated as the time weighted sum of PID scores over 2 hours on Day 3, with a total score ranges from -10 (higher pain relief) to 12 (lower pain relief). SPID is a value of change from baseline. Pain score at base line is usually higher than that at post baseline. So negative value of SPID indicates pain relief from baseline, while positive value means a worst pain comparing to baseline, a negative value of SPID indicates higher pain relief from baseline.|Over 6 hours on Day 1, over 2 hours on Day 3|The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.||units on a scale||Standard Error|Least Squares Mean
655754|NCT01945034|Secondary|Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points|PI in ankle pain at rest and upon weight bearing was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. Pain score at baseline is usually higher than that at post baseline. So negative value of SPID indicates pain relief from baseline, while positive value means a worst pain comparing to baseline.|Baseline, 1, 2, 3, 4, 5, 6, 12(Day1),24(Day2),30(Day2),36(Day2),48(Day3),50(Day3),54(Day3),60(Day3),72(Day4),78(Day4),84(Day4), 96(Day5),102(Day5), 108 (Day5), 120(Day6),126(Day6),132(Day6),144(Day7),150(Day7),156(Day7) hours post first dose on Day 1|The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.||units on a scale||Standard Error|Least Squares Mean
655755|NCT01945034|Secondary|Change From Baseline in Physician Global Assessment of Ankle Injury at Day 3 and 10|The physician assessment of the severity of the ankle injury was based on the participant’s individual signs and symptoms which included pain, swelling, tenderness and limitation of range of movement, and was measured using 6-point scale: 0= Normal (No signs or symptoms) , 1= Very mild (Very mild signs and symptoms), 2= Mild (Mild signs and symptoms), 3= Moderate (Moderate signs and symptoms), 4= Severe (Severe signs and symptoms), 5= Very severe (Very severe signs and symptoms). A higher score is indicative of lesser improvement. Change from baseline was calculated as baseline value minus post-treatment value.|Baseline, Day 3, 10|The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.||units on a scale||Standard Error|Least Squares Mean
655756|NCT01945034|Secondary|Change From Baseline in Participant’s Global Assessment of Ankle Injury at Day 3 and 10|Participant’s global assessments of ankle injury was measured using 5-point scale: 1= Very Good (No symptoms and no limitations of normal activities), 2= Good (Mild symptoms and no limitation of normal activities), 3= Fair (Moderate symptoms and limitations of some normal activities), 4= Poor (Severe symptoms and inability to carry out most normal activities), 5= Very Poor (Very severe symptoms which are intolerable and inability to carry out all normal activities).|Baseline, Day 3, 10|The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.||units on a scale||Standard Error|Least Squares Mean
655757|NCT01945034|Secondary|Sum of Pain Intensity Difference at Rest Over 24 Hours on Day 1 (SPID R24)|PI was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted sum of PID scores over 24 hours. Total score ranges from -240 (higher pain relief) to 96 (lower pain relief) for SPID at rest. SPID is a value of change from baseline. Pain score at base line is usually higher than that at post baseline. So negative value of SPID indicates pain relief from baseline, while positive value means a worst pain comparing to baseline, a negative value of SPID indicates higher pain relief from baseline.|0 to 24 hours|The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.||units on a scale||Standard Error|Least Squares Mean
655758|NCT01945034|Primary|Sum of Ankle Pain Intensity Difference on Weight Bearing Over 24 Hours After Dose 1 (SPID WB24)|PI was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted sum of PID scores over 24 hours. Total score ranges from -120 (higher pain relief) to 144 (lower pain relief) for SPID WB24. SPID is a value of change from baseline. Pain score at base line is usually higher than that at post baseline. So negative value of SPID indicates pain relief from baseline, while a positive value means a worst pain comparing to baseline, a negative value of SPID indicates higher pain relief from baseline.|0 to 24 hours|The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.||units on a scale||Standard Error|Least Squares Mean
655759|NCT01945034|Primary|Sum of Pain Intensity Difference (SPID) on Weight Bearing Over 3 Days (SPID WB0-3)|PI was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. Pain intensity difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted sum of PID scores over 3 days (72 hours). Total score ranges from -360 (higher pain relief) to 432 (lower pain relief) for SPID WB0-3. SPID is a value of change from baseline and as pain score at base line is usually higher than that at post baseline, a negative value of SPID indicates higher pain relief from baseline.|Over 3 Days (0-72 hours)|The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.||units on a scale||Standard Error|Least Squares Mean
655854|NCT01943474|Secondary|Catheter Dwell Time|Will measure total catheter dwell time to the nearest hour (total time in hours for functioning catheter) ~ up to 7 days.|Study Exit/At catheter removal (~ up to 7 days)|||hours||Standard Deviation|Mean
657377|NCT01923480|Secondary|Plasma Concentration of Aspartic Acid||Three times during each 7 hour visit|One subject completed Period 1, but withdrew from the study prior to the start of Period 2.||micromol/L||Standard Deviation|Mean
655771|NCT01944969|Secondary|Change in Health-related Quality of Life|The EuroQoL 5 Dimensions 5L version (EQ-5D-5L) Visual Analogue Scale (VAS) is a patient-reported assessment designed to measure the patient’s wellbeing. It consists of 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a visual analogue scale (VAS) of the overall health state. Each descriptive item is rated on a 5-point index ranging from 1 (no problems) to 5 (extreme problems) and a single summary index (from 0 to 1) can be calculated. The VAS ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).|Baseline and Week 52|No patients completed the study. Only 26 patients were enrolled at prematurely study termination (Planned: 1184 patients). Due to the limited number of enrolled patients, no data were summarised for reporting and the data did not allow for any meaningful analyses.|||||
655772|NCT01944969|Secondary|Change in Health-related Quality of Life|Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-(SF)) total score|From baseline to Week 52|No patients completed the study. Only 26 patients were enrolled at prematurely study termination (Planned: 1184 patients).|||||
655773|NCT01944969|Secondary|Change in Clinical Global Impression|Clinical Global Impression - Severity of illness (CGI-S) score|From baseline to Week 52|No patients completed the study. Only 26 patients were enrolled at prematurely study termination (Planned: 1184 patients).|||||
655774|NCT01944969|Secondary|Proportion of Patients in Remission|Based on a pre-specified MADRS total score|From baseline to Week 52|No patients completed the study. Only 26 patients were enrolled at prematurely study termination (Planned: 1184 patients).|||||
655775|NCT01944969|Secondary|Change in Depressive Symptoms|The Montgomery and Aasberg Depression Rating Scale (MADRS) total score|From baseline to Week 52|None of the patients completed the study. A total of 26 patients were enrolled when the study was prematurely terminated(Planned: 1184 patients).|||||
655776|NCT01944969|Secondary|Number of Patients With Risk of Suicidality Assessed Using the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS)|The Columbia Suicide Severity Rating Scale (eC-SSRS) is a semi-structured interview developed to systematically assess suicidal ideation and behaviour of patients participating in a clinical study. The C-SSRS has 5 questions addressing suicidal ideation, 5 sub-questions assessing the intensity of ideation, and 4 questions addressing suicidal behaviour. The electronic C-SSRS (eC-SSRS) is a patient-rated electronic version using interactive voice response technology. A structured CSSRS script of standardised questions, follow-up prompts, error-handling and scoring conventions is used for administration.|From baseline to Week 52|all-patients treated set (APTS)||participants|||Number
655777|NCT01944969|Primary|Tolerability|Number of withdrawals|From baseline to Week 52|26 patients were withdrawn; the reason for withdrawal was not poor tolerability, but mainly (23 patients) because the study was terminated. Please see withdrawn reasons in the participant flow section for the other reasons.||participants|||Number
655778|NCT01944969|Primary|Safety|Number of adverse events|From baseline to Week 52|||Adverse events|||Number
655779|NCT01944878|Secondary|The Association Between PUD and HVPG in Patients With Chronic Hepatitis||Retrospective case-control study (from 2009 to 2012, up to 3 years)|||mmHg||Inter-Quartile Range|Median
655780|NCT01944878|Primary|The Association of HVPG and PUD in Patients With Liver Cirrhosis|"The association of hepatic vein pressure gradient that reflects portal hypertension and peptic ulcer disease in patients with liver cirrhosis was assessed statistically.
(NO specific time frame, only confined to 2009 to 2012, when the HVPG measurement was done). The Mann-Whitney test was used to evaluate the association between PUD or not and HVPG degree, by SPSS software."|Retrospective case-control study (from 2009 to 2012, up to 3 years)|||mmHg||Inter-Quartile Range|Median
655781|NCT01944774|Secondary|Subject Number of Success and Failure in Overall Efficacy at Visit 3 in BE (Bacteriological Evaluable) Population|Only subjects whose bacterial culture from visit 1 was positive would be evaluated for the overall efficacy. The overall efficacy (cured or ineffective) at Visit 3 and treatment group (determined by each subject) was determined by the number and percentage of subjects. The difference in bacteriological success between Nemonoxacin malate sodium chloride injection and Moxifloxacin Hydrochloride Sodium Chloride Injection was tested using the logistic regression model.|Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug)|Subjects in the b-mITT population who conformed to the protocol analysis plan with no major violation to the protocol were enrolled into the BE population.||participants|||Number
655782|NCT01944774|Secondary|Subject Number of Success and Failure in Overall Efficacy at Visit 3 in b-mITT (Bacteriological mITT) Population|Only subjects whose bacterial culture from visit 1 was positive would be evaluated for the overall efficacy. The overall efficacy (cured or ineffective) at Visit 3 and treatment group (determined by each subject) was determined by the number and percentage of subjects. The difference in bacteriological success between Nemonoxacin malate sodium chloride injection and Moxifloxacin Hydrochloride Sodium Chloride Injection was tested using the logistic regression model.|Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug)|Subjects in the mITT population whose bacterial culture yielded at least one baseline bacterial isolate were enrolled into the b-mITT population.||participants|||Number
655783|NCT01944774|Secondary|Subject Number of Success and Failure in Overall Efficacy at Visit 4 in BE (Bacteriological Evaluable) Population|Only subjects whose bacterial culture from visit 1 was positive would be evaluated for the overall efficacy. The overall efficacy (cured or ineffective) at Visit 4 and treatment group (determined by each subject) was determined by the number and percentage of subjects. The difference in bacteriological success between Nemonoxacin malate sodium chloride injection and Moxifloxacin Hydrochloride Sodium Chloride Injection was tested using the logistic regression model.|Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug)|Subjects in the b-mITT population who conformed to the protocol analysis plan with no major violation to the protocol were enrolled into the BE population.||participants|||Number
655784|NCT01944774|Secondary|Subject Number of Success and Failure in Overall Efficacy at Visit 4 in b-mITT (Bacteriological mITT) Population|Only subjects whose bacterial culture from visit 1 was positive would be evaluated for the overall efficacy. The overall efficacy (cured or ineffective) at Visit 4 and treatment group (determined by each subject) was determined by the number and percentage of subjects. The difference in bacteriological success between Nemonoxacin malate sodium chloride injection and Moxifloxacin Hydrochloride Sodium Chloride Injection was tested using the logistic regression model.|Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug)|Subjects in the mITT population whose bacterial culture yielded at least one baseline bacterial isolate were enrolled into the b-mITT population.||participants|||Number
655785|NCT01944774|Secondary|Subject Number for Microbiologically Cured and Failure at Visit 3 in BE (Bacteriological Evaluable) Population|"Microbiological efficacy at visits 3 would be determined by assessing the identification results from the central laboratory. Subjects must satisfy at least one of the following in order to be evaluated for the microbiological efficacy:
Subjects whose respiratory culture from visit 1 was positive;
Subjects whose blood culture from visit 1 was positive.
The microbiological efficacy at Visit 3 and treatment group (determined by each subject) was determined by the number and percentage of microbiological success subjects. The difference in bacteriological success between Nemonoxacin malate sodium chloride injection and Moxifloxacin Hydrochloride Sodium Chloride Injection was tested using the logistic regression model."|Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug)|Subjects in the b-mITT population who conformed to the protocol analysis plan with no major violation to the protocol were enrolled into the BE population.||participants|||Number
655786|NCT01944774|Secondary|Subject Number for Microbiologically Cured and Failure at Visit 3 in b-mITT (Bacteriological mITT) Population|"Microbiological efficacy at visits 3 would be determined by assessing the identification results from the central laboratory. Subjects must satisfy at least one of the following in order to be evaluated for the microbiological efficacy:
Subjects whose respiratory culture from visit 1 was positive;
Subjects whose blood culture from visit 1 was positive.
The microbiological efficacy at Visit 3 and treatment group (determined by each subject) was determined by the number and percentage of microbiological success subjects. The difference in bacteriological success between Nemonoxacin malate sodium chloride injection and Moxifloxacin Hydrochloride Sodium Chloride Injection was tested using the logistic regression model."|Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug)|Subjects in the mITT population whose bacterial culture yielded at least one baseline bacterial isolate were enrolled into the b-mITT population.||participants|||Number
655787|NCT01944774|Secondary|Subject Number for Microbiologically Cured and Failure at Visit 4 in BE (Bacteriological Evaluable) Population|"Microbiological efficacy at visits 4 would be determined by assessing the identification results from the central laboratory. Subjects must satisfy at least one of the following in order to be evaluated for the microbiological efficacy:
Subjects whose respiratory culture from visit 1 was positive;
Subjects whose blood culture from visit 1 was positive.
The microbiological efficacy at Visit 4 and treatment group (determined by each subject) was determined by the number and percentage of microbiological success subjects. The difference in bacteriological success between Nemonoxacin malate sodium chloride injection and Moxifloxacin Hydrochloride Sodium Chloride Injection was tested using the logistic regression model."|Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug)|Subjects in the b-mITT population who conformed to the protocol analysis plan with no major violation to the protocol were enrolled into the BE population.||participants|||Number
655788|NCT01944774|Secondary|Subject Number for Microbiologically Cured and Failure at Visit 4 in b-mITT (Bacteriological mITT) Population|"Microbiological efficacy at visits 4 would be determined by assessing the identification results from the central laboratory. Subjects must satisfy at least one of the following in order to be evaluated for the microbiological efficacy:
Subjects whose respiratory culture from visit 1 was positive;
Subjects whose blood culture from visit 1 was positive.
The microbiological efficacy at Visit 4 and treatment group (determined by each subject) was determined by the number and percentage of microbiological success subjects. The difference in bacteriological success between Nemonoxacin malate sodium chloride injection and Moxifloxacin Hydrochloride Sodium Chloride Injection was tested using the logistic regression model."|Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug)|Subjects in the mITT population whose bacterial culture yielded at least one baseline bacterial isolate were enrolled into the b-mITT population.||participants|||Number
655789|NCT01944774|Secondary|Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 3 in the CE Population|The primary efficacy endpoint of this study was to evaluate whether the clinical cure rate of Nemonoxacin malate sodium chloride is non-inferior to that of Moxifloxacin at visit 3 in the CE population. At visit 3, the Investigator would assess changes in the symptoms/signs/laboratory tests and chest X-rays/or CT scans associated with this infection, and determined the clinical efficacy in the subjects. The clinical efficacy of the study group and the control group was calculated according to the proportion and percentage of overall clinically cured and clinically ineffective patients in the treatment groups. If the lower limit of the 90% confidence interval for the difference in the clinical cure rate between the study drug and the control drug was larger than ‒15%, it would be established that the efficacy of Nemonoxacin malate sodium chloride injection was not inferior to that of Moxifloxacin Hydrochloride Sodium Chloride Injection in the treatment of moderate to severe adult CAP.|Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug)|Subjects in the mITT population that conformed to the protocol analysis plan with no major violation to the protocol were enrolled into the CE population.||participants|||Number
655790|NCT01944774|Secondary|Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 3 in the mITT Population|The primary efficacy endpoint of this study was to evaluate whether the clinical cure rate of Nemonoxacin malate sodium chloride is non-inferior to that of Moxifloxacin at visit 3 in the mITT population. At visit 3, the Investigator would assess changes in the symptoms/signs/laboratory tests and chest X-rays/or CT scans associated with this infection, and determined the clinical efficacy in the subjects. The clinical efficacy of the study group and the control group was calculated according to the proportion and percentage of overall clinically cured and clinically ineffective patients in the treatment groups. If the lower limit of the 90% confidence interval for the difference in the clinical cure rate between the study drug and the control drug was larger than ‒15%, it would be established that the efficacy of Nemonoxacin malate sodium chloride injection was not inferior to that of Moxifloxacin Hydrochloride Sodium Chloride Injection in the treatment of moderate to severe adult CAP.|Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug)|Subjects in the ITT population that met the minimal disease criteria, and was evaluated for clinical efficacy at least once were enrolled into the mITT population.||participants|||Number
655855|NCT01943474|Secondary|Complications of Peripheral IV Therapy|Will measure the rate of observed (anticipated) complications of IV therapy - infection, occlusion, infiltration, extravasation, phlebitis, dislodgement, leaking/bleeding at site, patient complaints of pain without other identifiable cause, and other (~ up to 7 days).|From during to post IV catheter placement up to study exit (~ up to 7 days)|||percentage of participants||95% Confidence Interval|Number
655791|NCT01944774|Secondary|Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 4 in the Clinically Evaluable (CE) Population|The primary efficacy endpoint of this study was to evaluate whether the clinical cure rate of Nemonoxacin malate sodium chloride is non-inferior to that of Moxifloxacin at visit 4 in the CE population. At visit 4, the Investigator would assess changes in the symptoms/signs/laboratory tests and chest X-rays/or CT scans associated with this infection, and determined the clinical efficacy in the subjects. The clinical efficacy of the study group and the control group was calculated according to the proportion and percentage of overall clinically cured and clinically ineffective patients in the treatment groups. If the lower limit of the 90% confidence interval for the difference in the clinical cure rate between the study drug and the control drug was larger than ‒15%, it would be established that the efficacy of Nemonoxacin malate sodium chloride injection was not inferior to that of Moxifloxacin Hydrochloride Sodium Chloride Injection in the treatment of moderate to severe adult CAP.|Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug)|Subjects in the mITT population that conformed to the protocol analysis plan with no major violation to the protocol were enrolled into the CE population.||participants|||Number
655792|NCT01944774|Primary|Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 4 in the mITT Population|The primary efficacy endpoint of this study was to evaluate whether the clinical cure rate of Nemonoxacin malate sodium chloride is non-inferior to that of Moxifloxacin at visit 4 in the mITT population. At visit 4, the Investigator would assess changes in the symptoms/signs/laboratory tests and chest X-rays/or CT scans associated with this infection, and determined the clinical efficacy in the subjects. The clinical efficacy of the study group and the control group was calculated according to the proportion and percentage of overall clinically cured and clinically ineffective patients in the treatment groups. If the lower limit of the 90% confidence interval for the difference in the clinical cure rate between the study drug and the control drug was larger than ‒15%, it would be established that the efficacy of Nemonoxacin malate sodium chloride injection was not inferior to that of Moxifloxacin Hydrochloride Sodium Chloride Injection in the treatment of moderate to severe adult CAP.|Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug)|Subjects in the ITT population that met the minimal disease criteria, and was evaluated for clinical efficacy at least once were enrolled into the mITT population.||participants|||Number
655793|NCT01944670|Primary|Recurrent Dislocations|"To confirm that the Internal Joint Stabilizer – Elbow (IJS-E) provides temporary stabilization of the elbow joint and allows functional recovery after trauma or chronic dislocation.
The study is deemed a success if the at least 75% of patients do not have a recurrent dislocation while using the IJS-E or after removal of the IJS-E."|8 months (6 month post-explant)|Patients implanted with the Internal Joint Stabilizer - Elbow (IJS-E) who completed the study (have final follow-up data). Excludes patients who were lost to follow-up.||Participants|||Count of Participants
655794|NCT01944670|Primary|Broberg Morrey Functional Rating|"To confirm that the Internal Joint Stabilizer – Elbow (IJS-E) provides temporary stabilization of the elbow joint and allows functional recovery after trauma or chronic dislocation.
The study is deemed a success if the at least 75% of patients receive a Broberg Morrey Functinoal Rating of Fair or better."|Eight months (6 months post-explant)|Patients implanted with the Internal Joint Stabilizer - Elbow (IJS-E) who completed the study (have final follow-up data). Excludes patients who were lost to follow-up.||Participants|||Count of Participants
655795|NCT01944631|Secondary|Patient Overall Assessment of Efficacy|"Patient overall assessment of efficacy was assessed by the question How effective was the treatment in relieving your common cold symptoms? at day 10. A 5-point scale was used (0=poor, 1=fair, 2=good, 3=very good, 4=excellent)."|Day 10|FAS||percentage of participants|||Number
655796|NCT01944631|Secondary|Duration of the Cold|"Duration of the common cold was assessed by the question Do you still have a cold? at the end of each treatment day. The duration of the cold was defined as ended by the first day of a No answer to this daily question."|Baseline up to 10 days|FAS||days||95% Confidence Interval|Median
655797|NCT01944631|Secondary|Area Under the Curve (AUC) Over the 10-day Period for the TSS (AUC-TSS 1-10)|"The total symptom score (TSS) is the sum of the 8 single common cold symptom scores consisting of 3 systemic (headache, muscle ache and chilliness) and 5 local (sore throat, blocked nose, runny nose, cough and sneezing) symptoms.
Each common cold symptom was scored on a 4-point ordinal scale:
0 = symptom not present
1 = mild symptom (I can feel it but it has not disturbed or irritated me)
2 = moderate symptom (symptom has disturbed and irritated me some of the time)
3 = severe symptom (symptom has disturbed and irritated me most of the time)
The Area under the curve (AUC) over the 10-day period for the total symptom score (AUC-TSS 1-10) was calculated as the sum of the TSS calculated on each day from day 1 to day 10. AUC-TSS 1-10 ranges from 0 (no symptoms) to 270 (severe symptoms)."|Days 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10|FAS||units on a scale * days||Standard Error|Least Squares Mean
655798|NCT01944631|Secondary|Mean of the Sum of 5 Single Local Common Cold Symptom Scores Mean Over Days 2 to 4 (LSS2-4)|"The mean of the sum of 5 single local common cold symptom scores (sore throat, blocked nose, runny nose, cough and sneezing).
Each common cold symptom was scored on a 4-point ordinal scale:
0 = symptom not present
1 = mild symptom (I can feel it but it has not disturbed or irritated me)
2 = moderate symptom (symptom has disturbed and irritated me some of the time)
3 = severe symptom (symptom has disturbed and irritated me most of the time)
The mean of the sum of 5 single local common cold symptom scores over days 2 to 4 was calculated as (LSS2 + LSS3 + LSS4)/3 where LSS2, LSS3 and LSS4 are the local common cold symptom scores calculated for days 2, 3 and 4 respectively. LSS2-4 ranges from 0 (no symptoms) to 15 (severe symptoms)."|Days 2, 3 and 4|FAS||units on a scale||Standard Error|Least Squares Mean
655799|NCT01944631|Secondary|Mean of the Sum of 3 Single Systemic Common Cold Symptom Scores Over Days 2 to 4 (SSS2-4)|"The mean of the sum of 3 single systemic common cold symptom scores (headache, muscle ache, chilliness).
Each common cold symptom was scored on a 4-point ordinal scale:
0 = symptom not present
1 = mild symptom (I can feel it but it has not disturbed or irritated me)
2 = moderate symptom (symptom has disturbed and irritated me some of the time)
3 = severe symptom (symptom has disturbed and irritated me most of the time)
The mean of the sum of 3 single systemic common cold symptom scores over days 2-4 was calculated as (SSS2 + SSS3 + SSS4)/3 where SSS2, SSS3 and SSS4 are the systemic common cold symptom scores calculated for days 2, 3 and 4 respectively. SSS2-4 ranges from 0 (no symptoms) to 9 (severe symptoms)."|Days 2, 3 and 4|FAS||units on a scale||Standard Error|Least Squares Mean
655800|NCT01944631|Primary|Total Symptom Score (TSS) Over Days 2 to 4 (TSS2-4)|"The total symptom score (TSS) is the sum of the 8 single common cold symptom scores consisting of 3 systemic (headache, muscle ache and chilliness) and 5 local (sore throat, blocked nose, runny nose, cough and sneezing) symptoms.
Each common cold symptom was scored on a 4-point ordinal scale:
0 = symptom not present
1 = mild symptom (I can feel it but it has not disturbed or irritated me)
2 = moderate symptom (symptom has disturbed and irritated me some of the time)
3 = severe symptom (symptom has disturbed and irritated me most of the time)
The mean over days 2 to 4 (TSS2-4) was calculated as (TSS2 + TSS3 + TSS4)/3 where TSS2, TSS3 and TSS4 are the total symptom scores calculated for days 2, 3 and 4 respectively. TSS2-4 ranges from 0 (no symptoms) to 24 (severe symptoms)."|Days 2, 3 and 4|Full analysis set (FAS) which included all randomised patients who used at least one dose of trial treatment, who provided a baseline total symptom score (TSS) as well as any post-treatment data for the primary endpoint.||units on a scale||Standard Error|Least Squares Mean
655801|NCT01944345|Secondary|Radiological Assessment|Determination of fusion assessment, subsidence or migration of the device and confirmed radiographic dated|Post-operative follow up|26 (of 30) Cervical Patients 30 (of 39) Lumbar Patients||participants|||Number
655802|NCT01944345|Primary|Change in VAS Pain|"VAS Pain comparison Preoperative vs post-operative of greater than or equal to 6.
VAS PAIN SEVERITY SCALE ranges from 0-10. A score of zero (0) means ‘no pain’ and a ten (10) means 'worst imaginable pain'"|Pre-operative and Post-operative 12 months|Total subjects: 30 Cervical subjects, 39 Lumbar subjects. VAS PAIN SEVERITY SCALE ranges from 0-10. Zero = no pain, 10 - worst imaginable pain||Units on a scale 0-10||Standard Deviation|Mean
655803|NCT01944345|Primary|Change in Oswestry Disability Index (ODI)/Neck Disability Index (NDI) Score Range 0-50|ODI/NDI Score Range: 0-50 0-4 No disability 5-14 Mild disability 15-24 Moderate disability 25-34 Severe disability >34 Complete disability|Pre-operative and Post-operative 12 months post-operative|Combined cervical and lumbar patients: 30 cervical, 39 lumbar. Mean ODI/NDI was calculated for all patients at preop and 12 month.||Units on a scale 0-50||Standard Deviation|Mean
655804|NCT01944319|Secondary|Bacteriological Success Rate|"The bacterial success or failure will be evaluated at the end of meropenem therapy.
Bacteriological success including eradication and presumed eradication. Bacteriological failure including persistence and presumed persistence."|At the end of meropenem therapy, an average of 10 days.|||participants|||Number
655805|NCT01944319|Secondary|Amount of Used Antibiotics|Record the amount of antibiotics usage during antibiotic therapy|participants will be followed for the duration of antibiotic therapy, an average of 10 days|||grams||Inter-Quartile Range|Median
655806|NCT01944319|Primary|Clinical Success Rate|"The clinical success or failure of meropenem therapy will be evaluated one week after stop of antibiotic therapy.
Clinical success was defined as cure or improvement of all signs and symptoms caused by the infection and no requirement for additional antibacterial therapy.
Clinical failure was defined as a persistence or worsening of any new clinical sign or symptom, development of any new clinical signs or symptoms of infection, or the requirement for other systemic antimicrobial therapy at the end of meropenem therapy."|One week after antibiotic therapy finished.|||participants|||Number
655807|NCT01944059|Secondary|HIT-6|Differences in the scores for the HIT-6 disability inventory between baseline and the last study visit will be analyzed.|4-6 months|Study funding ended prematurely. Blinding information not provided by Funder. Data analysis was not completed.|||||
655808|NCT01944059|Secondary|Percent Change in Migraine and Headache Frequency|The percent change in migraine and headache frequency will be defined as [frequency/baseline phase - frequency/treatment phase] divided by [frequency/baseline phase].|4-6 months|Study funding ended prematurely. Blinding information not provided by Funder. Data analysis was not completed.|||||
655809|NCT01944059|Primary|Number of Migraine/Headache Days|The primary outcome measure will be the frequency of migraine and all headache days in the Theramine active group versus the Theramine placebo group during the treatment period.|4-6 months|Study funding ended prematurely. Blinding information not provided by Funder. Data analysis was not completed.|||||
655810|NCT01943864|Secondary|Number of Participants With Independent Radiologist Assessed Duration of Response|Duration of response was summarized for participants with a confirmed CR or PR and is defined as the time (in weeks) from the initial response (CR/PR) to first documented disease progression or death due to any cause. If a participant received subsequent anti-cancer therapy prior to the date of documented progression or death, PFS in the participant was censored at the last adequate assessment prior the initiation of the new anti-cancer therapy. Otherwise, if a participant did not have a documented date of progression or death, PFS in the participant was censored at the last adequate assessment.|Up to Week 37|ITT Population with a time to response event. Only 1 participant reached PR therefore estimated time to response cannot be presented. At the data cut off, this patient is censored. Therefore, the observed value of duration of response is unknown.||Participants|||Number
655811|NCT01943864|Secondary|Number of Participants With Investigator-Assessed Duration of Response|Duration of response was summarized for participants with a confirmed CR or PR and is defined as the time (in weeks) from the initial response (CR/PR) to first documented disease progression or death due to any cause. If a participant received subsequent anti-cancer therapy prior to the date of documented progression or death, PFS in the participant was censored at the last adequate assessment prior the initiation of the new anti-cancer therapy. Otherwise, if a participant did not have a documented date of progression or death, PFS in the participant was censored at the last adequate assessment.|Up to Week 37|ITT Population with a time to response event.||Participants|||Number
655812|NCT01943864|Secondary|Number of Weeks Until Time to Response Assessed With Independent Radiologist|Time to response (TTR) event was defined as achievement of a confirmed CR or PR, as the time from date of randomization until date of first documented evidence of CR or PR (whichever status is recorded first). If a participant received subsequent anti-cancer therapy prior to the date of documented progression or death, progression free survival (PFS) in the participant was censored at the last adequate assessment prior the initiation of the new anti-cancer therapy. Otherwise, if a participant did not have a documented date of progression or death, PFS in the participant was censored at the last adequate assessment. Only 1 participant reached PR therefore estimated time to response cannot be presented. The time to response for this patient is presented as the actual number of weeks to PR.|Up to Week 37|ITT Population. Only 1 participant reached PR therefore estimated time to response cannot be presented. The time to response for this patient is presented as the actual number of weeks to PR.||Weeks|||Number
655813|NCT01943864|Secondary|Number of Participants With Investigator-Assessed Time to Response|Time to response (TTR) event was defined as achievement of a confirmed CR or PR, as the time from date of randomization until date of first documented evidence of CR or PR (whichever status is recorded first). If a participant received subsequent anti-cancer therapy prior to the date of documented progression or death, progression free survival (PFS) in the participant was censored at the last adequate assessment prior the initiation of the new anti-cancer therapy. Otherwise, if a participant did not have a documented date of progression or death, PFS in the participant was censored at the last adequate assessment.|Up to Week 37|ITT Population.|||||
655814|NCT01943864|Secondary|Number of Participants With Overall Response Rate as Assessed by Independent Radiologist Per RECIST 1.1 Criteria|Overall Response Rate (ORR) is defined as the number of participants achieving a confirmed CR or PR per RECIST 1.1 criteria from the start of treatment until disease progression or the start of new anti-cancer therapy. ORR was based on responses from the Independent Radiologist assessment of best overall response, the best overall response is the best response recorded from the start of the treatment until disease progression/recurrence. ORR is calculated as CR + PR.|Up to Week 37|ITT Population.||Participants|||Number
655815|NCT01943864|Secondary|Number of Participants With Overall Response Rate as Assessed by Investigator Per RECIST 1.1 Criteria|Overall Response Rate (ORR) is defined as the number of participants achieving a confirmed CR or PR per RECIST 1.1 criteria from the start of treatment until disease progression or the start of new anti-cancer therapy. ORR was based on responses from the Investigator assessment of best overall response, the best overall response is the best response recorded from the start of the treatment until disease progression/recurrence. ORR is calculated as CR + PR.|Up to Week 37|ITT Population.||Participants|||Number
655816|NCT01943864|Secondary|Number of Participants With Overall Survival|Overall Survival (OS) is defined as the interval of time (in weeks) between the date of randomization and the date of death due to any cause. For participants that did not die, time of death was censored at the date of last contact. The date of death was taken from that recorded on the Record of Death page. Death on study due to any cause was included. One year OS was calculated from Kaplan-Meier estimates.|Up to Week 39|ITT Population.||Participants|||Number
655817|NCT01943864|Secondary|Number of Participants With Progression-Free Survival as Assessed by Independent Radiologist|Progression-Free Survival (PFS) is defined as the interval of time (in weeks) between the date of randomization and the earlier of the date of disease progression and the date of death due to any cause. Disease progression was based on the assessments by the independent radiologist. If a participant received subsequent anti-cancer therapy prior to the date of documented progression or death, PFS in the participant was censored at the last adequate assessment prior the initiation of the new anti-cancer therapy. Otherwise, if a participant did not have a documented date of progression or death, PFS in the participant was censored at the last adequate assessment.|Up to Week 37|ITT Population.||Participants|||Number
655818|NCT01943864|Secondary|Number of Participants With Progression-Free Survival as Assessed by Investigator|Progression-Free Survival (PFS) is defined as the interval of time (in weeks) between the date of randomization and the earlier of the date of disease progression and the date of death due to any cause. Disease progression was based on the assessments by the Investigator. If a participant received subsequent anti-cancer therapy prior to the date of documented progression or death, PFS in the participant was censored at the last adequate assessment prior the initiation of the new anti-cancer therapy. Otherwise, if a participant did not have a documented date of progression or death, PFS in the participant was censored at the last adequate assessment.|Up to Week 37|ITT Population.||Participants|||Number
655819|NCT01943864|Secondary|Change From Baseline in Oxygen Saturation (SpO2)|Oxygen Saturation was measured at Baseline (Day 1), Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32 and Week 36. For records occurring after baseline, change from baseline was calculated as the post baseline value minus the baseline value. When either the baseline or visit value was missing, the change from baseline was considered to be missing.|From Baseline up to Week 36|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Only those participants with analyzable data at the indicated time point were assessed (represented by n=x).||Percent oxygen saturation||Standard Deviation|Mean
655820|NCT01943864|Secondary|Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in Pulse Rate|Pulse rate was categorized as Decrease to <60, Change to Normal or No Change, and Increase to >100. Change from baseline was calculated as the post baseline value minus the baseline value. A Worst Post Baseline (WPB) change is defined as the worst change that occurred at any measured timepoint during the treatment period. Participants with missing baseline measurements or visit measurements were considered to be missing.|From Baseline up to Week 36|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Only those participants with analyzable data at the indicated time point were assessed (represented by n=x).||Participants|||Number
655821|NCT01943864|Secondary|Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in Blood Pressure|Systolic and diastolic blood pressure was measured after sitting for at least 5 minutes. Systolic blood pressure (SBP) was categorized as: Grade 0 (<120), Grade 1 (>=120-<140), Grade 2 (>=140-<160) and Grade 3 (>=160). Diastolic blood pressure (DBP) was categorized as Grade 0 (<80), Grade 1 (>=80-<90), Grade 2 (>=90-<100), and Grade 3 (>=100). Change from baseline was calculated as the post baseline value minus the baseline value. A Worst Post Baseline (WPB) change is defined as the worst change that occurred at any measured timepoint during the treatment period. Participants with missing baseline measurements or visit measurements were considered to be missing.|From Baseline up to Week 36|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Only those participants with analyzable data at the indicated time point were assessed (represented by n=x).||Participants|||Number
655856|NCT01943474|Secondary|Completion of IV Therapy|Completion of IV therapy will measure whether the catheter remained in place for the duration of required intravenous treatment during the inpatient stay (~ up to 7 days).|Study exit/At catheter removal (~ up to 7 days)|||percentage of participants||95% Confidence Interval|Number
656065|NCT01940497|Secondary|Duration of Treatment With Trastuzumab|Data for this outcome measure were analyzed and reported by adjuvant versus neoadjuvant chemotherapy groups within each treatment arm.|Day 1 up last dose of trastuzumab (assessed up to cut off date 05 April 2016; up to approximately 1 year)|Safety population||days||Standard Deviation|Mean
655822|NCT01943864|Secondary|Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in Body Temperature|Body temperature was categorized as Decrease to <=35; Change to Normal or No Change and Increase to >=38. Change from baseline was calculated as the post baseline value minus the baseline value. A Worst Post Baseline (WPB) change is defined as the worst change that occurred at any measured timepoint during the treatment period. Participants with missing baseline measurements or visit measurements were considered to be missing.|From Baseline up to Week 36|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Only those participants with analyzable data at the indicated time point were assessed (represented by n=x).||Participants|||Number
655823|NCT01943864|Secondary|Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in Carcinoembryonic Antigen Measurements With Respect to the Normal Range|Change from baseline was calculated as the post baseline value minus the baseline value for carcinoembryonic antigen (CEA). A Worst Post Baseline (WPB) change is defined as the worst change that occurred at any measured timepoint during the treatment period. Measurements were designated as either Decreased to Low (DTL) or Increased to High (ITH) or Change to Normal/No Change (CN/NC). Participants with missing baseline measurements or visit measurements were considered to be missing. Participants were counted twice if the participant Decreased to Low and Increased to High.|From Baseline up to Week 36|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Only those participants with analyzable data at the indicated time point were assessed (represented by n=x).||Participants|||Number
655824|NCT01943864|Secondary|Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in Hematology Measurements With Respect to the Normal Range|Change from baseline was calculated as the post baseline value minus the baseline value for basophils, eosinophils, and monocytes. A Worst Post Baseline (WPB) change is defined as the worst change that occurred at any measured timepoint during the treatment period. Measurements were designated as either Decreased to Low (DTL) or Increased to High (ITH) or Change to Normal/No Change (CN/NC). Participants with missing baseline measurements or visit measurements were considered to be missing. Participants were counted twice if the participant Decreased to Low and Increased to High.|From Baseline up to Week 36|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Only those participants with analyzable data at the indicated time point were assessed (represented by n=x).||Participants|||Number
655825|NCT01943864|Secondary|Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in Prothrombin Time Measurements With Respect to the Normal Range|Change from baseline was calculated as the post baseline value minus the baseline value for prothrombin time (PT). A Worst Post Baseline (WPB) change is defined as the worst change that occurred at any measured timepoint during the treatment period. Measurements were designated as either Decreased to Low (DTL) or Increased to High (ITH) or Change to Normal/No Change (CN/NC). Participants with missing baseline measurements or visit measurements were considered to be missing. Participants were counted twice if the participant Decreased to Low and Increased to High.|From Baseline up to Week 36|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Only those participants with analyzable data at the indicated time point were assessed (represented by n=x).||Participants|||Number
655826|NCT01943864|Secondary|Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in Clinical Chemistry Measurements With Respect to the Normal Range|Change from baseline was calculated as the post baseline value minus the baseline value for cancer antigen 19-9 (CA 19-9), chloride, lactate dehydrogenase (LDH), and urea. A Worst Post Baseline (WPB) change is defined as the worst change that occurred at any measured timepoint during the treatment period. Measurements were designated as either Decreased to Low (DTL) or Increased to High (ITH) or Change to Normal/No Change (CN/NC). Participants with missing baseline measurements or visit measurements were considered to be missing. Participants were counted twice if the participant Decreased to Low and Increased to High.|From Baseline up to Week 36|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Only those participants with analyzable data at the indicated time point were assessed (represented by n=x).||Participants|||Number
655827|NCT01943864|Secondary|Number of Participants With the Indicated Worst-case On-therapy Hematology Grade Shifts From Baseline|Shift from baseline was calculated as the post baseline value minus the baseline value for hemoglobin, lymphocytes, neutrophils, platelets, and leukocytes. A Worst Post Baseline (WPB) grade shift is defined as the worst change that occurred at any measured timepoint during the treatment period. Grading was determined by the NCI Common Terminology Criteria for Adverse Events Version 3.0 (NCI-CTCAE). Participants with missing baseline grade were designated a baseline grade of 0.|From Baseline up to Week 36|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Only those participants with analyzable data at the indicated time point were assessed (represented by n=x).||Participants|||Number
655828|NCT01943864|Secondary|Number of Participants With the Indicated Worst-case On-therapy Coagulation Grade Shifts From Baseline|Shift from baseline was calculated as the post baseline value minus the baseline value for activated partial thromboplastin time (APTT) and prothrombin time (PT). A Worst Post Baseline (WPB) grade shift is defined as the worst change that occurred at any measured timepoint during the treatment period. Grading was determined by the NCI Common Terminology Criteria for Adverse Events Version 3.0 (NCI-CTCAE). Participants with missing baseline grade were designated a baseline grade of 0.|From Baseline up to Week 36|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Only those participants with analyzable data at the indicated time point were assessed (represented by n=x).||Participants|||Number
655857|NCT01943474|Primary|First Attempt Success Rate With Peripheral IV Catheter Placement|The primary outcomes measure is to observe first attempt success rate in patients requiring peripheral IV access by documenting the number of catheter attempts (each new catheter) required to complete successful peripheral IV placement.|At catheter placement, an expected average of 10 minutes|||percentage of participants||95% Confidence Interval|Number
657378|NCT01923480|Secondary|Plasma Concentration of Arginine||Three times during each 7 hour visit|One subject completed Period 1, but withdrew from the study prior to the start of Period 2.||micromol/L||Standard Deviation|Mean
655829|NCT01943864|Secondary|Number of Participants With the Indicated Worst-case On-therapy Clinical Chemistry Grade Shifts From Baseline|Shift from baseline was calculated as the post baseline value minus the baseline value for albumin, alkalaine phosphatase (AP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, creatine kinase (CK), creatinine, hypercalcemia, hyperglycemia, hyperkalemia, hypermagnesemia, hypernatremia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia, and phosphate. A Worst Post Baseline (WPB) grade shift is defined as the worst change that occurred at any measured timepoint during the treatment period. Grading was determined by the NCI Common Terminology Criteria for Adverse Events Version 3.0 (NCI-CTCAE). Participants with missing baseline grade were designated a baseline grade of 0.|From Baseline up to Week 36|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Only those participants with analyzable data at the indicated time point were assessed (represented by n=x).||Participants|||Number
655830|NCT01943864|Secondary|Expression of Interstitial Lung Disease Marker Surfactant Protein D|Interstitial lung disease marker Surfactant Protein D assessments were carried out at Baseline (Day 1), Week 12, and Week 28|Baseline, Week 12, and Week 28|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Only those participants with analyzable data at the indicated time point were assessed (represented by n=x).||Micrograms per litre (µ/L)||Standard Deviation|Mean
655831|NCT01943864|Secondary|Expression of Interstitial Lung Disease Marker KL-6|Interstitial lung disease markers KL-6 assessments were carried out at Baseline (Day 1), Week 12, Week 20, Week 24, Week 28, Week 32, and Week 36|From Baseline up to Week 36|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Only those participants with analyzable data at the indicated time point were assessed.||Units/milliliter (U/mL)||Standard Deviation|Mean
655832|NCT01943864|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect or Protocol-Specific SAEs|until 26-Feb-2016|ITT Population.||Participants|||Number
655833|NCT01943864|Primary|Number of Participants With Indicated Non-progressive Disease as Assessed by Independent Radiologist Per Response Evaluation Criteria In Solid Tumor Version 1.1 (RECIST 1.1) at Week 12|Twelve week non-progressive disease (PD) at Week 12 was evaluated by computed tomography. Non- PD was calculated as the sum of complete response (CR), partial response (PR), and stable disease (SD).|Up to Week 12|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.||Participants|||Number
655834|NCT01943864|Primary|Number of Participants With Indicated Non-progressive Disease as Assessed by Investigator Per Response Evaluation Criteria In Solid Tumor Version 1.1 (RECIST 1.1) at Week 12|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the diameters of target lesions; Stable Disease(SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Progressive Disease(PD), At least a 20% increase in the sum of the diameters of target lesions. Non-PD = CR + PR + SD.|Up to Week 12|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.||Participants|||Number
655835|NCT01943565|Secondary|Intraoperative Vasopressor Use: Phenylephrine Equivalents|"IT (intrathecal ) applied local anesthetics and opioids can cause arterial and venous vasodilation leading to a decrease in afterload as well as preload. This is typically treated with volume replacement and vasopressors (acutely).
Total intraoperative vasopressor use will be reported for phenylephrine equivalents."|Intraoperatively (at time of operation)|One 25 mcg patient is missing data on this outcome||mcg||Standard Deviation|Mean
655836|NCT01943565|Secondary|Intraoperative Vasopressor Use: Ephedrine Equivalents|IT (intrathecal) applied local anesthetics and opioids can cause arterial and venous vasodilation leading to a decrease in afterload as well as preload. This is typically treated with volume replacement and vasopressors (acutely). Total intraoperative vasopressor use will be reported for ephedrine equivalents.|Intraoperatively (at time of operation)|One 25 mcg patient is missing data on this outcome||mg||Standard Deviation|Mean
655837|NCT01943565|Secondary|Number of Patients With Pruritus|IT opioids can cause pruritus. Persistent pruritus requiring treatment will be recorded.|24hrs post administration of IT hydromorphone|One 25 mcg patient is missing data on this outcome||Participants|||Count of Participants
655838|NCT01943565|Secondary|Number of Patients With Visual Disturbances|IT/IV opioids can create visual disturbances. The number of patients with visual disturbances are reported.|24hrs post administration of IT hydromorphone|||Participants|||Count of Participants
655839|NCT01943565|Secondary|Number of Patients With Hypothermia (Body Temperature < 95F/35C)|intrathecally administered opioids can cause hypothermia (body temperature <95F/35C)|24hrs post administration of IT hydromorphone|One 25 mcg patient was missing data on this measure||Participants|||Count of Participants
655840|NCT01943565|Secondary|Patients With Nausea and Vomiting Requiring Rescue Medication|IV and IT opioids can induce nausea and vomiting. Outcome measure is reported as percentage of patients with nausea and vomiting requiring rescue medication.|24hrs post administration of IT hydromorphone|One 25 mcg patient was missing data on this measure||Participants|||Count of Participants
655841|NCT01943565|Secondary|Oxygen Saturation, Need for Supplemental Oxygen|Intravenously, and to a lesser extent, intrathecally administered opioids can lead to respiratory depressions. Therefore the subjects' oxygen saturation is measured (standard clinical practice).|24hrs post administration of IT hydromorphone|One 25 mcg patient is missing data on this outcome||percentage oxygenated haemoglobin||Standard Deviation|Mean
655842|NCT01943565|Primary|24hr Post-partum IV Opioid Requirement|Intrathecal (IT) hydromorphone added to intrathecally administered local anesthetics for spinal anesthesia increases patient comfort by decreasing post-operative pain. This leads to a decrease in the post-operative intravenous hydromorphone requirements.|24hrs after administration of intrathecal hydromorphone|One 25 mcg patient is missing data on this outcome||mg||Standard Deviation|Mean
655843|NCT01943552|Secondary|Main Post-operative Pulmonary Complications (Including Pneumonia, Atelectasis and Acute Respiratory Failure) Within Three Weeks After the Surgery|Number of patients with at least one main post-operative pulmonary complications (including pneumonia, atelectasis and acute respiratory failure) within three weeks after the surgery. Post-operative pneumonia was defined by the presence of the following criteria: persistent lung infiltrate on chest X-ray or chest computerized tomography (CT)-scan, white blood cell count >10,000 /mm3 and fever. Post-operative atelectasis was diagnosed by presence of atelectasis affecting one lobe or several lobes in chest X-ray test or chest CT-scan. Post-operative acute respiratory failure was defined by the presence of: PaO2 < 60 mmHg and/or PaCO2 > 50 mmHg while breathing air or other evidences which were considered as respiratory failure by investigators.|From surgery to 3 weeks post surgery, up to 21 days|Surgery complete set (SCS): All patients who completed surgery.||Participants|||Number
655844|NCT01943552|Secondary|Change of Blood Gas Analyses From Pre-bronchodilator at Baseline to Post-nebulization One Day Before the Surgery: Arterial Carbon Dioxide Pressure (PaCO2) Value|Change of blood gas analyses from pre-bronchodilator at baseline to post-nebulization one day before the surgery (Treatment day 3): arterial carbon dioxide pressure (PaCO2) value|Baseline and Treatment day 3|Full analysis set (FAS). (Only patients with observed cases (OC) values were analysed)||mmHg||Standard Error|Least Squares Mean
655845|NCT01943552|Secondary|Change of Blood Gas Analyses From Pre-bronchodilator at Baseline to Post-nebulization One Day Before the Surgery: Oxygen Saturation|Change of blood gas analyses from pre-bronchodilator at baseline to post-nebulization one day before the surgery (Treatment day 3): Oxygen saturation|Baseline and Treatment day 3|Full analysis set (FAS). (Only patients with observed cases (OC) values were analysed)||Percentage of Oxygen||Standard Error|Least Squares Mean
655846|NCT01943552|Secondary|Change of Blood Gas Analyses From Pre-bronchodilator at Baseline to Post-nebulization One Day Before the Surgery: Arterial Oxygen Pressure (PaO2) Value|Change of blood gas analyses from pre-bronchodilator at baseline to post-nebulization one day before the surgery (Treatment day 3): arterial oxygen pressure (PaO2) value|Baseline and Treatment day 3|Full analysis set (FAS). (Only patients with observed cases (OC) values were analysed)||mmHg||Standard Error|Least Squares Mean
655847|NCT01943552|Secondary|Change of Forced Vital Capacity (FVC) From Pre-bronchodilator at Baseline to Post-nebulization One Day Before the Surgery|Change of forced vital capacity (FVC) from pre-bronchodilator at baseline to post-nebulization one day before the surgery (Treatment day 3). Measurements of FVC were performed using calibrated electronic spirometers. Equipment and techniques should conform to American Thoracic Society (ATS) criteria (P05-12782). At Visit 1, pulmonary function testing (PFT) was performed at baseline and repeated 30 minutes following inhalation of 4 puffs of salbutamol hydrofluoroalkanes metered-dose inhaler (HFA MDI). At Visit 3, pulmonary function testing was performed 60 minutes following the inhalation of investigational drug. Spirometry was conducted with the patient in a seated position having abstained from medications. The best of three efforts was defined as the highest FVC each obtained on any of three efforts meeting the ATS criteria and it was selected regardless of whether they came from different spirometric manoeuvres or the same manoeuvre.|Baseline and Treatment day 3|Full analysis set (FAS). (Only patients with observed cases (OC) values were analysed)||ml||Standard Error|Least Squares Mean
655848|NCT01943552|Primary|Change of Forced Expiratory Volume in 1 Second (FEV1) From Pre-bronchodilator at Baseline to Post-nebulization One Day Before the Surgery|Change of forced expiratory volume in 1 second (FEV1) from pre-bronchodilator at baseline to post-nebulization one day before the surgery (Treatment day 3). Measurements of FEV1 were performed using calibrated electronic spirometers. Equipment and techniques should conform to American Thoracic Society (ATS) criteria (P05-12782). At screening visit, pulmonary function testing (PFT) was performed at baseline and repeated 30 minutes following inhalation of 4 puffs of salbutamol hydrofluoroalkanes metered-dose inhaler (HFA MDI). At treatment day 3, pulmonary function testing was performed 60 minutes following the inhalation of investigational drug. Spirometry was conducted with the patient in a seated position having abstained from medications. The best of three efforts was defined as the highest FEV1 each obtained on any of three efforts meeting the ATS criteria and it was selected regardless of whether they came from different spirometric manoeuvres or the same manoeuvre.|Baseline and Treatment day 3|Full analysis set (FAS): All patients in the treated set who had observed analysable data in at least one efficacy endpoint. (Only patients with observed cases (OC) values were analysed)||ml||Standard Error|Least Squares Mean
655849|NCT01943474|Secondary|Patient Satisfaction With Overall IV Performance|Patient satisfaction with overall IV performance at IV removal using a 5-point Likert scale. 5 - Very satisfied, 4 - Somewhat satisfied, 3 - Neutral, 2 - Somewhat unsatisfied, 1 - Very unsatisfied. 3 and above are considered positive. 2 and below are considered negative.|At IV removal (usually after 1-7 days of IV dwell time)|||units on a scale||Standard Deviation|Mean
655850|NCT01943474|Secondary|Patient Satisfaction Comfort Comparison|Patient satisfaction with comfort of IV insertion compared to most recent previous IV insertion using a 5-point Likert scale. 5 - Very satisfied, 4 - Somewhat satisfied, 3 - Neutral, 2 - Somewhat unsatisfied, 1 - Very unsatisfied. 3 and above are considered positive. 2 and below are considered negative.|Immediately after catheter insertion, within the first 3-15 minutes of insertion procedure.|||units on a scale||Standard Deviation|Mean
655851|NCT01943474|Secondary|Adverse Events|Will measure the number and severity of adverse events associated with peripheral IV initiation and indwelling catheter time (anticipated to be similar in both groups). This period will generally include up to 7 days of total IV dwell time.|During and post IV catheter placement until study exit (maximum of 6 months).|||percentage of participants|||Number
655852|NCT01943474|Secondary|Clinician Satisfaction|Will measure clinician satisfaction of the AccuCath IV device via a 5 point Likert scale survey based on overall catheter performance during experience and use. 5 - Very satisfied, 4 - Somewhat satisfied, 3 - Neutral, 2 - Somewhat unsatisfied, 1 - Very unsatisfied. 3 and above are considered positive. 2 and below are considered negative.|At completion of study after all patients have been enrolled (approximately 6 months from study initiation)|||units on a scale||Full Range|Mean
655853|NCT01943474|Secondary|Patient Satisfaction At Insertion|Will survey patients regarding satisfaction with catheter insertion using a 5-point Likert scale. 5 - Very satisfied, 4 - Somewhat satisfied, 3 - Neutral, 2 - Somewhat unsatisfied, 1 - Very unsatisfied. 3 and above are considered positive. 2 and below are considered negative.|At catheter insertion, initial 3-15 minutes after insertion procedure completed.|||units on a scale||Standard Deviation|Mean
655861|NCT01943344|Other Pre-specified|Performance|Assessed by technical success rate for the VIVASURE CLOSURE DEVICE™|up to 3 month of implantation||||||
655862|NCT01943344|Secondary|Minor Vascular Complications Directly Related to Device|Incidence of minor complications directly related to the VIVASURE CLOSURE DEVICE™ up to 3 months from implantation, as defined by VARC-2.|up to 3 months from implantation||||||
655863|NCT01943344|Primary|Major Vascular Complications Directly Related to Device|Incidence and severity of major complication rates directly related to the VIVASURE CLOSURE DEVICE™ up to 3 months from implantation, (as defined by VARC-2) is no worse than those associated with cut-down and sutured close.|up to 3 Months of implantation|||participants|||Number
655864|NCT01943292|Secondary|Evaluate the Efficacy (Response Rate and Progression-free Survival) of Subjects Treated With Defactinib (VS-6063).|Response rate and progression-free survival, as determined by Response Evaluation Criteria In Solid Tumors (RECIST), version 1.1|Every 8 weeks up to end of treatment, an expected average of 12 weeks||||||
655865|NCT01943292|Secondary|Assess the Pharmacokinetics, Metabolism and Elimination of Defactinib (VS-6063) in Plasma and Urine.|PK parameters, including but not limited to plasma concentration, AUC (Area Under Curve) 0-t, Cmax, Tmax, and T1/2. Total 24-hour urine output will be collected in conjunction with PK sampling to assess the elimination of defactinib (VS-6063) and its potential metabolites.|Time points at Day 1 and Day 15 in Cycle 1||||||
655866|NCT01943292|Secondary|Define the Maximum Tolerated Dose (MTD), if Achieved, and Establish the Recommended Phase 2 Dose (RP2D) of Defactinib (VS-6063) in Japanese Subjects.|The RP2D will be determined based on the MTD of defactinib (VS-6063) as determined by number of participants with dose limiting toxicities (DLTs) related to defactinib.|From start of treatment to end of cycle 1 (21 day cycles)|||mg|||Number
655867|NCT01943292|Primary|Assess the Safety and Tolerability of Defactinib (VS-6063) in Japanese Subjects With Non-hematologic Malignancies|"A composite by dose level to include incidence of AEs, SAEs, dose interruptions and dose reductions as a measure of safety and tolerability. Abnormal Clinical significant laboratory results, ECG measurements, vital signs measurement, physical examination findings, and ECOG performance status were captured as adverse events.
The severity of AEs were evaluated according to CTCAE (Common Toxicity Criteria for Adverse Effects) 4.03"|From start of treatment to end of treatment, an expected average of 12 weeks|||participants|||Number
655868|NCT01943110|Secondary|Proportion of Injections With Safety Events|The proportion of injections with safety events will be calculated for events occurring within 30 minutes and within 48 hours of injection.|Within 30 minutes and within 48 hours of injection|||percentage of injections|Participants||Number
655869|NCT01943110|Primary|Proportion of Injections Delivered to the Intradermal Layer of the Skin|The proportion of saline injections resulting in delivery to the intradermal layer of the skin will be assessed by measurement of intradermal wheals with diameters ≥ 5mm and the volume of liquid injected.|1 day|||Injections|Participants||Number
655936|NCT01942148|Secondary|Mean Change From Baseline at Final Assessment in Clinical Global Impression-Severity of Illness (CGI-S) Score|The Clinical Global Impression-Severity of Illness (CGI-S) Score is a clinician rated scale which assesses how mentally ill the patient is at the time. Scores range from 0 to 7: 0 = Not assessed, 1= Normal, not at all ill, 2 =Borderline mentally ill, 3= Mildly ill, 4= Moderately ill, 5= Markedly ill, 6= Severely ill, 7= Among the most extremely ill patients. Higher scores indicate worse condition.|Basline and Week52|||units on a scale||Standard Deviation|Mean
655870|NCT01942785|Primary|CGI-I Score at Week 6 Patients With a Pre-defined Baseline BIS-11 Total Score|The subgroups denoted BIS-11_HIGH had a BIS-11 total score at Baseline ≥median at baseline and the subgroups denoted BIS-11_LOW had a BIS-11 total score <median at baseline. The Clinical Global Impression - global improvement CGI-I provides the clinician’s impression of the patient’s improvement (or worsening). The clinician assesses the patient’s condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). In all cases, the assessment should be made independent of whether the rater believes the improvement is drug-related or not. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Week 6|full-analysis set (FAS)||units on a scale||Standard Error|Mean
655871|NCT01942785|Primary|Change From Baseline to Week 6 in CGI-S Score in Patients With a Pre-defined Baseline BIS-11 Total Score|The subgroups denoted BIS-11_HIGH had a BIS-11 total score at Baseline ≥median at baseline and the subgroups denoted BIS-11_LOW had a BIS-11 total score <median at baseline. The Clinical Global Impression severity of illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients). As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 6|full-analysis set (FAS)||units on a scale||Standard Error|Mean
655872|NCT01942785|Primary|Change From Baseline to Week 6 in MADRS Total Score in Patients With a Pre-defined Baseline BIS-11 Total Score|The Montgomery and Åsberg Depression Rating Scale (MADRS) is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). The total score of the 10 items ranges from 0 to 60, with higher values indicating worse outcome. Subgroup analyses were performed for the change from Baseline to Week 6 in MADRS total score based on the patients’ BIS-11 total score at Baseline. The subgroups denoted BIS-11_HIGH had a BIS-11 total score at Baseline ≥median at baseline and the subgroups denoted BIS-11_LOW had a BIS-11 total score <median at baseline. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 6|full-analysis set (FAS)||units on a scale||Standard Error|Mean
655873|NCT01942785|Primary|Change From Week 6 to Week 10 in CGI-S Score|The Clinical Global Impression severity of illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients). As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Week 6 and Week 10|Completer's-analysis set (CAS)||units on a scale||Standard Error|Mean
655874|NCT01942785|Primary|Change From Week 6 to Week 10 in KSQ Depression Subscore|The Kellner Symptom Questionnaire (KSQ) is a patient-rated scale designed to assess distress using symptoms of depression, anxiety, anger-hostility, and somatization. The KSQ depression subscale score ranges from 0 to 23, with higher values indicating worse outcome . As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Week 6 and Week 10|Completer's-analysis set (CAS)||units on a scale||Standard Error|Mean
655875|NCT01942785|Primary|Change From Week 6 to Week 10 in KSQ Anger-hostility Subscore|The Kellner Symptom Questionnaire (KSQ) is a patient-rated scale designed to assess distress using symptoms of depression, anxiety, anger-hostility, and somatization. The KSQ anger-hostility subscale score ranges from 0 to 23 with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Week 6 and Week 10|Completer's-analysis set (CAS)||units on a scale||Standard Error|Mean
655876|NCT01942785|Primary|Change From Week 6 to Week 10 in BIS-11 Total Score|The Barratt Impulsiveness Scale, Version 11 (BIS-11) is a patient-rated scale designed to assess impulsive personality traits. The BIS-11 consists of 30 items scored on a 4-point scale ranging from 1 (rarely/never) to 4 (almost always/always). The scores provide information to assess 6 first-order factors (attention, motor, self-control, cognitive complexity, perseverance, and cognitive instability impulsiveness) and 3 second-order factors (motor impulsiveness, non-planning impulsiveness, and attentional impulsiveness). The total score ranges from 30 to 120 with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Week 6 and Week 10|Completer's-analysis set (CAS). Only patients who have observed data at Week 10 were included in the ANCOVA analysis.||units on a scale||Standard Error|Mean
655877|NCT01942785|Primary|Change From Week 6 to Week 10 in Delay Discounting - MCQ Scores|The Monetary Choice Questionnaire (MCQ) is a patient-completed questionnaire designed to measure delay discounting, an index of impulsive behaviour. The MCQ consists of 27 choices between immediate and delayed rewards. The patients choose repeatedly between two hypothetical sums of money: a smaller amount now or a larger amount in the future (for example, ‘‘Would you prefer $27 today or $50 in 21 days?”). The answers provide an estimate of the patient’s discounting rate. The discounting rate parameter takes values between 0 and 1 and higher discounting rates indicate impulsivity. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Week 6 and Week 10|Completer's-analysis set (CAS). Only patients who have observed data at Week 10 were included in the ANCOVA analysis; the number of participants analysed is therefore smaller than the defined CAS.||log-transformed units on a scale||Standard Error|Mean
655878|NCT01942785|Primary|Change From Week 6 to Week 10 in SIS Item 1 Score|The Sheehan Irritability Scale (SIS) is a patient-rated scale designed to measure irritability. The SIS item 1 assess how much the patient has suffered from irritability in the past week, using verbal descriptors (not at all, mildly, moderately, markedly, and extremely) as well as numerical scores from 0 (not at all) to 10 (extremely) that provide more precise levels of the verbal descriptors. The SIS item 1 ranged from 0 to 10 with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Week 6 and Week 10|Completer's-analysis set (CAS). Only patients who have observed data at Week 10 were included in the ANCOVA analysis; the number of participants analysed is therefore smaller than the defined CAS.||units on a scale||Standard Error|Mean
657379|NCT01923480|Secondary|Plasma Concentration of Alanine||Three times during each 7 hour visit|One subject completed Period 1, but withdrew from the study prior to the start of Period 2.||micromol/L||Standard Deviation|Mean
655879|NCT01942785|Primary|Change From Week 6 to Week 10 in SIS Total Score|The Sheehan Irritability Scale (SIS) is a patient-rated scale designed to measure irritability. The SIS consists of 7 subscales assessing irritability, frustration, edginess/impatience/overreaction, moodiness, anger with self, anger with others, and temper. The patient rates the extent to which they have suffered from these symptoms. Each subscale has verbal descriptors (not at all, mildly, moderately, markedly, and extremely) as well as numerical scores from 0 (not at all) to 10 (extremely) that provide more precise levels of the verbal descriptors. One additional question assesses number of days impaired by irritability over the period. The subscales are summarised to give the total score which ranges from 0 to 70, with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Week 6 and Week 10|Completer's-analysis set (CAS)||units on a scale||Standard Error|Mean
655880|NCT01942785|Primary|Change From Baseline to Week 6 in Delay Discounting - EDT DRT Score|DRT consists of 60 choices between an immediate reward or a higher delayed reward. The number of impulsive choices will be a continuous variable estimated from how many immediate choices based on 60 possible. The number ranges between 0 and 60, with a higher value indicating more impulsivity. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 6|full-analysis set (FAS). Only patients who have observed data at Week 6 were included in the ANCOVA analysis; the number of participants analysed is therefore smaller than the defined FAS.||units on a scale||Standard Error|Mean
655881|NCT01942785|Primary|Change From Baseline to Week 6 in Delay Discounting - Log-transformed EDT DPDT Scores|DPDT consists of approximately 110 choices between an immediate reward or a higher delayed reward, and between an immediate reward or a higher reward that only comes with a certain probability. The tasks are scored independently of each other and do not yield a total score. There will be two derived variables from this task; a delayed discounting rate and a probability discounting rate. The delay discounting value takes values from 0 and up, a higher delay discounting value indicates greater impulsivity. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 6|full-analysis set (FAS). Only patients who have observed data at Week 6 were included in the ANCOVA analysis; the number of participants analysed is therefore smaller than the defined FAS.||log transformed units on a scale||Standard Error|Mean
655882|NCT01942785|Primary|Change From Baseline to Week 6 in KSQ Total Score|The Kellner Symptom Questionnaire (KSQ) is a patient-rated scale designed to assess distress using symptoms of depression, anxiety, anger-hostility, and somatization. The KSQ consists of 92 items which form the basis for the four subscales: depression, anxiety, anger-hostility, and somatic; of which 68 items indicate symptoms (symptom subscales) and 24 items are antonyms of some of the symptoms and indicate well-being (well-being subscales). A “yes” or “true” response on the symptom subscales scores 1, and a “no” or “false” on the well-being subscales scores 1. The maximum score for each symptom subscale is 17, and the maximum score for each well-being subscale is 6. The score of each subscale ranges from 0 to 23 (the sum of the symptom subscale and the well-being subscale). A higher score indicates more distress. The total score ranges from 0 to 92. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 6|Full-analysis set (FAS)||units on a scale||Standard Error|Mean
655883|NCT01942785|Primary|CGI-I Score at Week 6|The Clinical Global Impression - global improvement CGI-I provides the clinician’s impression of the patient’s improvement (or worsening). The clinician assesses the patient’s condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). In all cases, the assessment should be made independent of whether the rater believes the improvement is drug-related or not. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Week 6|Full-analysis set (FAS), this endpoint presents descriptive statistics for CGI-I based on patients who have CGI-I score observed at Week 6; the number of participants analysed is therefore smaller than the defined FAS.||units on a scale||Standard Error|Mean
655884|NCT01942785|Primary|Change From Baseline to Week 6 in CGI-S Score|The Clinical Global Impression severity of illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients). As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 6|Full-analysis set (FAS)||units on a scale||Standard Error|Mean
655885|NCT01942785|Primary|Change From Baseline to Week 6 in CPFQ Total Score|The Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) is a patient-rated scale designed to assess cognitive and executive dysfunction including symptoms of fatigue in mood and anxiety disorders. The CPFQ consists of 7 items, each rated on a scale from 1 (greater than normal functioning) to 6 (poorer than normal functioning). The total score of the 7 items ranges from 7 to 42, with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 6|Full-analysis set (FAS)||units on a scale||Standard Error|Mean
655886|NCT01942785|Primary|Change From Baseline to Week 6 in MADRS Total Score|The Montgomery and Åsberg Depression Rating Scale (MADRS) is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). The total score of the 10 items ranges from 0 to 60, with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 6|Full-analysis set (FAS)||units on a scale||Standard Error|Mean
655887|NCT01942785|Primary|Change From Baseline to Week 6 in KSQ Depression Subscore|The Kellner Symptom Questionnaire (KSQ) is a patient-rated scale designed to assess distress using symptoms of depression, anxiety, anger-hostility, and somatization. The KSQ depression subscale score ranges from 0 to 23, with higher values indicating worse outcome . As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 6|Full-analysis set (FAS)||units on a scale||Standard Error|Mean
656066|NCT01940497|Secondary|Actual Dose of Trastuzumab Administered|Actual dose (mg) administered = (sum over all cycles of actual dose received [mg] divided by number of cycles). Data for this outcome measure were analyzed and reported by adjuvant versus neoadjuvant chemotherapy groups within each treatment arm.|Day 1 up last dose of trastuzumab (assessed up to cut off date 05 April 2016; up to approximately 1 year)|Safety population||mg||Standard Deviation|Mean
655888|NCT01942785|Primary|Change From Baseline to Week 6 in IDS-C30 Total Score|The 30-item Inventory of Depressive Symptomatology - Clinician-Rated (IDS-C30) is a clinician-rated scale designed to assess the severity of depressive symptoms. The IDS-C30 consists of 30 items assessing the symptoms of depression, as well as commonly associated symptoms (for example, anxiety, irritability), and topics relevant to melancholic or atypical features; the patient rates only one of the 2 items assessing appetite (decreased or increased), and only one of the 2 items assessing weight (loss or gain). Each of the items is rated on a 4-point anchored scale from 0 (least severe) to 3 (most severe). The total score is the sum of the 28 scored items, and ranges from 0 to 84, with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 6|Full-analysis set (FAS)||units on a scale||Standard Error|Mean
655889|NCT01942785|Primary|Shift From Baseline to Week 6 in Anger Attacks (AAQ)|The Anger Attacks Questionnaire (AAQ) is a patient-rated scale designed to assess the presence of anger attacks over a period of time. The AAQ consists of 7 items. Patients are classified as having anger attacks when exhibiting the following 4 criteria: 1) irritability, 2) overreaction to minor annoyances, 3) occurrence of anger attacks (at least one of which occurred within the period), and 4) experienced 4 or more specific symptoms during at least one of the attacks. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 6|Full-analysis set (FAS) and OC. Only patients who have both baseline and Week 6 data observed were included; the number of participants analysed is therefore smaller than the defined FAS.||participants|||Number
655890|NCT01942785|Primary|Change From Baseline to Week 6 in KSQ Anger-hostility Subscore|The Kellner Symptom Questionnaire (KSQ) is a patient-rated scale designed to assess distress using symptoms of depression, anxiety, anger-hostility, and somatization. The KSQ anger-hostility subscale score ranges from 0 to 23 with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 6|Full-analysis set (FAS)||units on a scale||Standard Error|Mean
655891|NCT01942785|Primary|Change From Baseline to Week 6 in BIS-11 Total Score|The Barratt Impulsiveness Scale, Version 11 (BIS-11) is a patient-rated scale designed to assess impulsive personality traits. The BIS-11 consists of 30 items scored on a 4-point scale ranging from 1 (rarely/never) to 4 (almost always/always). The total score ranges from 30 to 120 with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 6|Full-analysis set (FAS)||units on a scale||Standard Error|Mean
655892|NCT01942785|Primary|Change From Baseline to Week 6 in Delay Discounting - Log-transformed MCQ Scores|The Monetary Choice Questionnaire (MCQ) is a patient-completed questionnaire designed to measure delay discounting, an index of impulsive behaviour. The MCQ consists of 27 choices between immediate and delayed rewards. The patients choose repeatedly between two hypothetical sums of money: a smaller amount now or a larger amount in the future (for example, ‘‘Would you prefer $27 today or $50 in 21 days?”). The answers provide an estimate of the patient’s discounting rate. The discounting rate parameter takes values between 0 and 1 and higher discounting rates indicate impulsivity. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 6|Full-analysis set (FAS)||log-transformed units on a scale||Standard Error|Mean
655893|NCT01942785|Primary|Change From Baseline to Week 6 in IDS-C30 Item 6 Score|The 30-item Inventory of Depressive Symptomatology - Clinician-Rated (IDS-C30) is a clinician-rated scale designed to assess the severity of depressive symptoms. The IDS-C30 item 6 measures mood (irritable) and is rated on a 4-point anchored scale from 0 (least severe) to 3 (most severe) with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 6|Full-analysis set (FAS)||units on a scale||Standard Error|Mean
655894|NCT01942785|Primary|Change From Baseline to Week 6 in SIS Item 1 Score|The Sheehan Irritability Scale (SIS) is a patient-rated scale designed to measure irritability. The SIS item 1 assess how much the patient has suffered from irritability in the past week. The SIS item 1 ranged from 0 to 10 with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 6|Full-analysis set (FAS)||units on a scale||Standard Error|Mean
655895|NCT01942785|Primary|Change From Baseline to Week 6 in SIS Total Score|The Sheehan Irritability Scale (SIS) is a patient-rated scale designed to measure irritability. The SIS consists of 7 subscales assessing irritability, frustration, edginess/impatience/overreaction, moodiness, anger with self, anger with others, and temper. The subscales are summarised to give the total score which ranges from 0 to 70, with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 6|Full-analysis set (FAS)||units on a scale||Standard Error|Mean
655896|NCT01942733|Primary|CGI-I Score at Week 8|The Clinical Global Impression - Global Improvement (CGI-I) assesses the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse), with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.||units on a scale||Standard Error|Mean
655897|NCT01942733|Primary|Change From Baseline to Week 8 in BRIAN Total Score|The Biological Rhythms Interview of Assessment in Neuropsychiatry (BRIAN) is a clinician-rated scale designed to assess biological rhythms. The BRIAN consists of 18 items divided in 4 subscales: sleep (5 items), activity (5 items), social (4 items), and eating pattern (4 items). Each item is rated on a scale from 1 (no difficulties) to 4 (serious difficulties). The total score of the 18 items ranges from 18 to 72, with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.||units on a scale||Standard Error|Mean
656088|NCT01940471|Primary|Percentage of Participants With Hepatitis B Virus (HBV) DNA < 29 IU/mL||Week 48|Full Analysis Set: participants who were randomized into the study and received at least 1 dose of study drugs. Participants were analyzed according to the treatment to which they were randomized.||percentage of participants|||Number
655898|NCT01942733|Primary|Changes From Baseline to Week 8 on Number of Awakenings (NAW) as Assessed by Actigraphy (ACT)|The key ACT parameters assessed were the total sleep time (ACT TST), sleep efficiency (ACT SE), sleep onset latency (ACT SOL), wake-time after sleep onset (ACT WASO), and the number of awakenings (ACT NAW). The results for ACT TST, ACT SE, ACT WASO, and ACT NAW are presented separately from ACT SOL as the number of patients available for analysis was different. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.||number of events||Standard Error|Mean
655899|NCT01942733|Primary|Changes From Baseline to Week 8 on Sleep Efficiency (SE) as Assessed by Actigraphy (ACT)|The key ACT parameters assessed were the total sleep time (ACT TST), sleep efficiency (ACT SE), sleep onset latency (ACT SOL), wake-time after sleep onset (ACT WASO), and the number of awakenings (ACT NAW). The results for ACT TST, ACT SE, ACT WASO, and ACT NAW are presented separately from ACT SOL as the number of patients available for analysis was different. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.||percentage of time||Standard Error|Mean
655900|NCT01942733|Primary|Changes From Baseline to Week 8 on Sleep Quality as Assessed by Actigraphy (ACT) Parameters|The key ACT parameters assessed were the total sleep time (ACT TST), wake-time after sleep onset (ACT WASO), sleep onset latency (ACT SOL), sleep efficiency (ACT SE), and the number of awakenings (ACT NAW). The results for ACT TST, ACT WASO, and ACT SOL are presented separately from ACT SE, and from ACT NAW, due to the different units of measurement involved. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.||minutes||Standard Error|Mean
655901|NCT01942733|Primary|Percentage of MADRS Remitters at Week 8|The Montgomery Aasberg Depression Rating Scale (MADRS) is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Items in the scale assess apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Symptoms are rated on a 7-point scale from 0 (no symptoms) to 6 (severe symptoms). Definitions of severity are provided at two-point intervals. The total score of the 10 items ranges from 0 to 60, with higher values indicating worse outcome. Remission was defined as a MADRS total score ≤10 and a ≥50% decrease in MADRS total score from baseline. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.||percentage of patients|||Number
655902|NCT01942733|Primary|Percentage of MADRS Responders at Week 8|The Montgomery Aasberg Depression Rating Scale (MADRS) is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Items in the scale assess apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Symptoms are rated on a 7-point scale from 0 (no symptoms) to 6 (severe symptoms). Definitions of severity are provided at two-point intervals. The total score of the 10 items ranges from 0 to 60, with higher values indicating worse outcome. Response was defined as a ≥50% decrease in MADRS total score from baseline. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.||percentage of patients|||Number
655903|NCT01942733|Primary|Change From Baseline to Week 8 in CGI-S Score|The Clinical Global Impression - Severity of Illness (CGI-S) scale assesses the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients), with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.||units on a scale||Standard Error|Mean
655904|NCT01942733|Primary|Change From Baseline to Week 8 in MADRS Total Score|The Montgomery Aasberg Depression Rating Scale (MADRS) is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Items in the scale assess apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Symptoms are rated on a 7-point scale from 0 (no symptoms) to 6 (severe symptoms). Definitions of severity are provided at two-point intervals. The total score of the 10 items ranges from 0 to 60, with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.||units on a scale||Standard Error|Mean
655905|NCT01942733|Primary|Changes From Baseline to Week 8 in Circadian and Biological Rhythm|The parameters used to assess circadian and biological rhythm were the time to peak cortisol concentration, time to dim-light melatonin onset (DLMO) and phase angle. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.||minutes||Standard Error|Mean
657566|NCT01920282|Secondary|Insulin Sensitivity (HOMA-IR)|The HOMA index was calculated as the product of plasma blood glucose and insulin divided by 22.5.|12 weeks|||Arbitrary units||Standard Error|Mean
655906|NCT01942733|Primary|Change From Baseline to Week 8 in CPFQ Total Score|The Cognitive and Physical Functioning Questionnaire (CPFQ) is a patient-rated scale designed to assess cognitive and executive dysfunction including symptoms of fatigue in mood and anxiety disorders. The CPFQ consists of 7 items, each rated on a scale from 1 (greater than normal functioning) to 6 (poorer than normal functioning). The total score of the 7 items ranges from 7 to 42, with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.||units on a scale||Standard Error|Mean
655907|NCT01942733|Primary|Change From Baseline to Week 8 on BL-VAS-s Scores (Noon)|The Bond-Lader Visual Analogue Scale – Sedation (BL-VAS-s) is a patient-rated scale designed to assess the current level of sedation. The BL-VAS-s was assessed for the evening (19:00 to 23:59 hours), morning (00:00 to 08:59 hours) and at noon (11:00 to 13:59 hours). The BL-VAS-s is a single item scale rated on a 100mm visual analogue scale. The score is measured from the left to a mark made on the line by the patient and ranges from 0 (alert) to 100 (drowsy). As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.||units on a scale||Standard Error|Mean
655908|NCT01942733|Primary|Change From Baseline to Week 8 on BL-VAS-s (Morning) Score|The Bond-Lader Visual Analogue Scale – Sedation (BL-VAS-s) is a patient-rated scale designed to assess the current level of sedation. The BL-VAS-s was assessed for the evening (19:00 to 23:59 hours), morning (00:00 to 08:59 hours) and at noon (11:00 to 13:59 hours). The BL-VAS-s is a single item scale rated on a 100mm visual analogue scale. The score is measured from the left to a mark made on the line by the patient and ranges from 0 (alert) to 100 (drowsy). As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.||units on a scale||Standard Error|Mean
655909|NCT01942733|Primary|Change From Baseline to Week 8 on BL-VAS-s (Evening) Score|The Bond-Lader Visual Analogue Scale – Sedation (BL-VAS-s) is a patient-rated scale designed to assess the current level of sedation. The BL-VAS-s was assessed for the evening (19:00 to 23:59 hours), morning (00:00 to 08:59 hours) and at noon (11:00 to 13:59 hours). The BL-VAS-s is a single item scale rated on a 100mm visual analogue scale. The score is measured from the left to a mark made on the line by the patient and ranges from 0 (alert) to 100 (drowsy). As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.||units on a scale||Standard Error|Mean
655910|NCT01942733|Primary|Changes From Baseline to Week 8 in Number of Lapses as Assessed Using a PVT Device|The psychomotor vigilance task (PVT) measures sustained or vigilant attention by recording response time (milliseconds) to a visual/or auditory stimulus that appears at random inter-stimulus intervals (range: from 2 to 10 seconds). The patient was instructed to monitor a red rectangular box on the computer screen and to press a response button as soon as a yellow stimulus counter appeared on the screen. The parameters assessed using a PVT device were response speed and number of lapses. The results for response speed is presented separately from the number of lapses due to the different units of measurement involved. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.||number||Standard Error|Mean
655911|NCT01942733|Primary|Changes From Baseline to Week 8 in Response Speed as Assessed Using a PVT Device|The psychomotor vigilance task (PVT) measures sustained or vigilant attention by recording response time (milliseconds) to a visual/or auditory stimulus that appears at random inter-stimulus intervals (range: from 2 to 10 seconds). The patient was instructed to monitor a red rectangular box on the computer screen and to press a response button as soon as a yellow stimulus counter appeared on the screen. The parameters assessed using a PVT device were response speed and number of lapses. The results for response speed is presented separately from the number of lapses due to the different units of measurement involved. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.||speed (per second)||Standard Error|Mean
655912|NCT01942733|Primary|Change From Baseline to Week 8 on ESS Total Score|The Epworth Sleepiness Scale (ESS) is a is a patient-rated scale designed to measure daytime sleepiness. The ESS consists of 8 items describing different situations/activities and the patients rate the chance of them dozing off or falling asleep when they are in these situations. Each item is rated on a 4-point scale from 0 (would never dose) to 3 (high change of dozing). The total score of the 8 items ranges from 0 to 24, with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.||units on a scale||Standard Error|Mean
655921|NCT01942733|Primary|Changes From Baseline to Week 8 on Sleep Quality as Assessed by Polysomnographic Recorded (PSG) Parameters|The key PSG parameters assessed were the latency to persistent sleep (PSG LPS), sleep onset latency (PSG SOL), wake-time after sleep onset (PSG WASO), total sleep time (PSG TST), number of awakenings (PSG NAW), and sleep efficiency (PSG SE). The results for PSG LPS, PSG SOL, PSG WASO, and PSG TST are presented separately from the PSG NAW, and from the PSG SE due to the different units of measurement involved. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.||minutes (min)||Standard Error|Mean
655913|NCT01942733|Primary|Change From Baseline to Week 8 in ISI Total Score|The Insomnia Severity Index (ISI) is a patient-rated scale desgined to measure the patient’s perception of his/her insomnia. The ISI comprises 7 items: difficulty falling asleep, difficulty staying asleep, problems waking up early in the morning, satisfaction with current sleep pattern, interference with daily functioning, how much others notice the sleep problem impairs quality of life, and distress caused by the sleep problem. Each of the 7 items is rated on a 5-point scale from 0 (best situation) to 4 (worst situation). The total score of the 7 items ranges from 0 to 28, with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.||units on a scale||Standard Error|Mean
655914|NCT01942733|Primary|Changes From Baseline to Week 8 in Sleep Architecture as Assessed With Polysomnography (Continued)|The key sleep architecture parameters assessed with polysomnography were the percentage of time and duration spent in Stages N1 (non–rapid eye movement [non-REM]), N2 (non-REM), N3 (non-REM), and REM, respectively, as well as the duration of latency to REM sleep. The results for the percentage of time spent at each stage is presented separately from the duration due to the different units of measurement involved. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.||minutes||Standard Error|Mean
655915|NCT01942733|Primary|Changes From Baseline to Week 8 in Sleep Architecture as Assessed With Polysomnography|The key sleep architecture parameters assessed with polysomnography were the percentage of time and duration spent in Stages N1 (non–rapid eye movement [non-REM]), N2 (non-REM), N3 (non-REM), and REM, respectively, as well as the duration of latency to REM sleep. The results for the percentage of time spent at each stage is presented separately from the duration due to the different units of measurement involved. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.||percentage of total sleep duration||Standard Error|Mean
655916|NCT01942733|Primary|Changes From Baseline to Week 8 on Sleep Quality as Assessed by the Consensus Sleep Diary for Morning (CSD-M) Number of Awakenings (NAW)|The key CSD-M parameters assessed were the sleep efficiency (CSD-M SE), total sleep time (CSD-M TST), sleep onset latency (CSD-M SOL), wake-time after sleep onset (CSD-M WASO), and number of awakenings (CSD-M NAW). As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.||number||Standard Error|Mean
655917|NCT01942733|Primary|Changes From Baseline to Week 8 on Sleep Quality as Assessed by the Consensus Sleep Diary for Morning (CSD-M)|The key CSD-M parameters assessed were the sleep efficiency (CSD-M SE), total sleep time (CSD-M TST), sleep onset latency (CSD-M SOL), wake-time after sleep onset (CSD-M WASO), and number of awakenings (CSD-M NAW). The results for CSD-M SE are presented separately from CSD-M TST, CSD-M SOL, and CSD-M WASO, and from CSD-M NAW due to the different units of measurement involved. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.||minutes (min)||Standard Error|Mean
655918|NCT01942733|Primary|Changes From Baseline to Week 8 on Sleep Quality as Assessed by the Consensus Sleep Diary for Morning (CSD-M) Sleep Efficiency (SE)|The key CSD-M parameters assessed were the sleep efficiency (CSD-M SE), total sleep time (CSD-M TST), sleep onset latency (CSD-M SOL), wake-time after sleep onset (CSD-M WASO), and number of awakenings (CSD-M NAW). The results for CSD-M SE are presented separately from CSD-M TST, CSD-M SOL, and CSD-M WASO, and from CSD-M NAW due to the different units of measurement involved. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.||percentage of time||Standard Error|Mean
655919|NCT01942733|Primary|Changes From Baseline to Week 8 on Sleep Quality as Assessed by Polysomnographic Recorded (PSG) Sleep Efficiency (PSG SE)|The key PSG parameters assessed were the latency to persistent sleep (PSG LPS), sleep onset latency (PSG SOL), wake-time after sleep onset (PSG WASO), total sleep time (PSG TST), number of awakenings (PSG NAW), and sleep efficiency (PSG SE). The results for PSG LPS, PSG SOL, PSG WASO, and PSG TST are presented separately from the PSG NAW, and from the PSG SE due to the different units of measurement involved. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.||percentage (%)||Standard Error|Mean
655920|NCT01942733|Primary|Changes From Baseline to Week 8 on Sleep Quality as Assessed by Polysomnographic Recorded (PSG) Number of Awakenings (PSG NAW)|The key PSG parameters assessed were the latency to persistent sleep (PSG LPS), sleep onset latency (PSG SOL), wake-time after sleep onset (PSG WASO), total sleep time (PSG TST), number of awakenings (PSG NAW), and sleep efficiency (PSG SE). The results for PSG LPS, PSG SOL, PSG WASO, and PSG TST are presented separately from the PSG NAW, and from the PSG SE due to the different units of measurement involved. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.||number of events||Standard Error|Mean
655922|NCT01942720|Secondary|Adverse Events (AE)|To assess safety related to capsule retention and other adverse events|6 months|all enrolled subjects||AE incidents|||Number
657720|NCT01916681|Primary|Length of Stay|Total maternal length of stay as defined as days from the day the induction began to the day of discharge|Days between admit to hospital and discharge|||Days||Inter-Quartile Range|Median
655923|NCT01942720|Secondary|Evaluate the Entire SB CE Scores|"Evaluate the entire SB CE Scores (Lewis & CECDEIS) change as compared to the change at TI in CE Scores (Lewis & CECDEIS).
Lewis Score scale: continuance scale variable, higher score higher disease severity (0- unlimited) remission <135 CECDEIS score scale: continuance scale variable, higher score higher disease severity (0-44) , no “normal range” Studies discuss a drop in the number as indicating healing but not a specific"|6 months change from Baseline|number of Lewis & CECDEIS TI score change is lower due to inability to identify TI. number of participants for this outcome measure includes participants with available data for total SB Lewis score change, TI Lewis score change, Total CECDEIS score change, TI Lewis score change, respectively||units on a scale||Standard Deviation|Mean
655924|NCT01942720|Secondary|Correlation Between the Change in SES CD Score and the Change in Capsule Scoring Indexes- in Terminal Ileum|Evaluate the correlation between the change in SES CD score and the change in capsule scoring indexes (Lewis and CECDEIS) in the TI after 6 months SES CD score scale 0-12, Higher score=higher disease severity Lewis Score scale: continuance scale variable, higher score higher disease severity (0- unlimited) remission <135 CECDEIS score scale: continuance scale variable, higher score higher disease severity (0-44) , no “normal range” Studies discuss a drop in the number as indicating healing but not a specific cutoff|6 months change from Baseline|number of subjects with Colonoscopy score is lower than number of subjects analyzed due to colonoscopy video malfunction. number of participants for this outcome measure includes participants with available data for TI SES CD, TI Lewis, TI CECDEIS scores, respectively||units on a scale||Standard Deviation|Mean
655925|NCT01942720|Secondary|Correlation Between SES CD (Simple Endoscopic Score for Chron's Disease) Score and Capsule Scoring Indexes|"Evaluate the correlation between SES CD score and capsule scoring indexes (Lewis and CECDEIS) in the TI (Terminal Ileum) at baseline.
SES CD score scale 0-12, Higher score=higher disease severity Lewis Score scale: continuance scale variable, higher score higher disease severity (0- unlimited) remission <135 CECDEIS score scale: continuance scale variable, higher score higher disease severity (0-44) , no “normal range” Studies discuss a drop in the number as indicating healing but not a specific"|Baseline|number of participants for this outcome measure includes participants with available data for SES CD, TI Lewis score, TI CECDEIS score, respectively||units on a scale||Standard Deviation|Mean
655926|NCT01942720|Primary|Mucosal Change in VCE (Video Capsule Endoscopy) Mucosal Scores and PGA (Physician Global Assessment)|To correlate the mucosal change in VCE mucosal score (Lewis score and CECDEIS( Capsule Endoscopy Crohn's Disease Endoscopic Index)) with change in Physician Global Assessment of CD activity 6 months after the first VCE procedure; PGA scale: 0-Normal, 1-Mild disease, 2- Moderate Disease, 3-Severe Disease Lewis Score scale: continuance scale variable, higher score higher disease severity (0- unlimited) remission <135 CECDEIS score scale: continuance scale variable, higher score higher disease severity (0-44) , no “normal range” Studies discuss a drop in the number as indicating healing but not a specific cutoff|6 months changefrom Baseline|Correlation between changes in VCE mucosal scores (Lewis and CECDEIS) and change in PGA score of CD (Crohn's Disease) activity from baseline to follow-up at 6 months; number of participants for this outcome measure includes participants with available data for PGA, SB (small bowel) Lewis score, SB CECDEIS score, respectively||units on a scale||Standard Deviation|Mean
655927|NCT01942707|Secondary|Ultrasound Control|An ultrasound of the abdominal wall will be realized to check if it there is any residual seroma (more than 30 ml of volume).|Done after 20 days of surgery|||ml||Standard Deviation|Mean
655928|NCT01942707|Secondary|Number of Days That the Drain Will Remain.|Number of days that the drain will remain. The drain will remain until the volume of drainage is less than 30ml in 24 hours .|Number of days required for drain to remain. The drain will remain until the volume of drainage is less than 30ml in 24 hours .|||days||Standard Deviation|Mean
655929|NCT01942707|Primary|The Volume of Drainage in ml.|We will measure the total volume of drainage, in ml, obtained by the drains in the abdominal region. The measure of drainage will be done at the same time and by the same nurse everyday in all patients until the drain is withdrawn. The drain will remain until the volume of drainage will be less than 30 ml in 24 hours. Total volume of drainage will be calculated as the sum of the volumes obtained daily.|until the drain is withdraw (volume less than 30 ml in 24h)|||ml||Standard Deviation|Mean
655930|NCT01942161|Secondary|Mean Change From Baseline at Final Assessment in Children's Global Assessment Scale (C-GAS) Score|The Children's Global Assessment Scale (C-GAS) is a rating scale which measures psychological, social and school functioning for children aged 6-17. Scores range from 0 to 100, with higher scores indicating better condition.|Baseline (Day 1) and Day 43|||units on a scale||Standard Error|Mean
655931|NCT01942161|Secondary|Mean Change From Baseline at Final Assessment in Clinical Global Impression-Improvement (CGI-I) Score|The Clinical Global Impression-Improvement (CGI-I) Score is a clinician rated scale which assesses the total improvement of the patient's condition compared to that at baseline. Scores range from 0 to 7: 0 = Not assessed, 1= Very much improved, 2 = Much improved, 3= Minimally improved, 4= No change, 5= Minimally worse, 6= Much worse, 7= Very much worse. Higher scores indicate worse condition.|Baseline (Day 1) and day43|||units on a scale||Standard Error|Mean
655932|NCT01942161|Secondary|Mean Change From Baseline at Final Assessment in Clinical Global Impression-Severity of Illness (CGI-S) Score|The Clinical Global Impression-Severity of Illness (CGI-S) Score is a clinician rated scale which assesses how mentally ill the patient is at the time. Scores range from 0 to 7: 0 = Not assessed, 1= Normal, not at all ill, 2 =Borderline mentally ill, 3= Mildly ill, 4= Moderately ill, 5= Markedly ill, 6= Severely ill, 7= Among the most extremely ill patients. Higher scores indicate worse condition.|Baseline (Day 1) and Day43|||units on a scale||Standard Error|Mean
655933|NCT01942161|Secondary|Mean Change From Baseline at Final Assessment in Positive and Negative Syndrome Scale (PANSS) Positive Subscale Total Score|The Positive and Negative Syndrome Scale (PANSS) positive subscale score is the sum of the 7 positive item scores (ie, delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution and hostility) and ranges from 7 to 49, with higher values indicating worse condition.|Baseline (Day 1) and Day 43|||units on a scale||Standard Error|Mean
655934|NCT01942161|Primary|Mean Change From Baseline at Final Assessment in Positive and Negative Syndrome Scale (PANSS) Total Score|The Positive and Negative Syndrome Scale (PANSS) is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7: 1 =Absent, 2 =Minimal, 3 =Mild, 4 =Moderate, 5 =Moderate severe, 6 =Severe, 7= Extreme. PANSS total score is calculated by adding score of 30 items, which ranges from 30-210. Higher scores indicate worse condition.|Baseline (Day 1) and Day 43|||units on a scale||Standard Error|Mean
655937|NCT01942148|Primary|Mean Change From Baseline at Final Assessment in Positive and Negative Syndrome Scale (PANSS) Total Score|The Positive and Negative Syndrome Scale (PANSS) is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7: 1 =Absent, 2 =Minimal, 3 =Mild, 4 =Moderate, 5 =Moderate severe, 6 =Severe, 7= Extreme. PANSS total score is calculated by adding score of 30 items, which ranges from 30-210. Higher scores indicate worse condition.|Basline and Week52|||units on a scale||Standard Deviation|Mean
655938|NCT01942135|Secondary|Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs; All Causalities)|An AE is any untoward medical occurrence in a clinical investigation patient administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. An SAE is any untoward medical occurrence at any dose that results in death; is life-threatening; requires hospitalization; results in persistent or significant disability or in congenital anomaly/birth defect. Severity will be graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0.|From the signing of the informed consent until 28 days after the last dose of study medication up to 14 months|The as-treated (AT) population or safety analysis set included all participants who received at least 1 dose of study medication, with treatment assignments designated according to actual study treatment received.||Percentage of Participants|||Number
655939|NCT01942135|Secondary|Time to Deterioration (TTD)|A time to event analysis was pre-specified for pain. An analysis of TTD in pain defined as time between baseline and first occurrence of increase of ≥10 points in pain. Deterioration will be defined increase in score of 10 points or greater from baseline. The Kaplan-Meier estimates of quartiles (time to deterioration) with 95% CI is mentioned below.|Baseline, Day 1 of Cycles 2 to 4, Day 1 of every alternate cycle after that until the end of treatment|The PRO –evaluable population is defined as a subset of ITT participants, who have completed a baseline and at least one post –baseline PRO assessment prior to end of study treatment.||Months||95% Confidence Interval|Median
655940|NCT01942135|Secondary|Change From Baseline Between Treatment Comparison in EQ-5D Visual Analog Scale (VAS) Scores Scale|The EuroQol-5D (version 3L) is a brief self-administered, validated instrument consisting of 2 parts. The second part consists of the EQ-5D general health status as measured by a visual analog scale (EQ-5D VAS). EQ-5D VAS measures the participant's self-rated health status on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state).|From Cycle 1 to 14, as of 05 December 2014.|The PRO –evaluable population is defined as a subset of ITT participants, who have completed a baseline and at least one post –baseline PRO assessment prior to end of study treatment. Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Units on a scale||95% Confidence Interval|Mean
655941|NCT01942135|Secondary|Change From Baseline Between Treatment Comparison in EuroQoL 5D (EQ-5D)- Health Index Scores|The EuroQol-5D (version 3L) is a brief self-administered, validated instrument consisting of 2 parts. The first part consists of 5 descriptors of current health state (mobility, self care, usual activities, pain/discomfort, and anxiety/ depression); a participant is asked to rate each state on a three level scale (1=no problem, 2=some problem, and 3=extreme problem) with higher levels indicating greater severity/ impairment Published weights are available that allow for the creation of a single summary score called the EQ-5D index, which basically ranges from 0 to 1 with low scores representing a higher level of dysfunction and 1 as perfect health. The second part consists of the EQ-5D general health status as measured by a visual analog scale (EQ-5D VAS). EQ-5D VAS measures the participant's self-rated health status on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state).|From Cycle 1 to 14, as of 05 December 2014.|The PRO –evaluable population is defined as a subset of ITT participants, who have completed a baseline and at least one post –baseline PRO assessment prior to end of study treatment. Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Units on a scale||95% Confidence Interval|Mean
655942|NCT01942135|Secondary|Change From Baseline Between Treatment Comparison in EORTC QLQ BR23 Symptom Scale Scores|The EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual functioning, sexual enjoyment, future perspective) and four symptom scales (systemic side effects, breast symptoms, arm symptoms, upset by hair loss). QLQ-BR23 questionnaire employs 4-point scales with responses from ’not at all’ to ’very much’. All scores are converted to a 0 to 100 scale. For symptom-oriented scales, a higher score represent more severe symptoms.|From Cycle 1 to 14, as of 05 December 2014.|The PRO –evaluable population is defined as a subset of ITT participants, who have completed a baseline and at least one post –baseline PRO assessment prior to end of study treatment. Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Units on a scale||95% Confidence Interval|Mean
655943|NCT01942135|Secondary|Change From Baseline Between Treatment Comparison in European Organization for Research and Treatment of Cancer Breast Cancer Module (EORTC QLQ BR23) Functional Scale Scores|The EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual functioning, sexual enjoyment, future perspective) and four symptom scales (systemic side effects, breast symptoms, arm symptoms, upset by hair loss). QLQ-BR23 questionnaire employs 4-point scales with responses from ’not at all’ to ’very much’. All scores are converted to a 0 to 100 scale. For functional scales, higher scores represent a better level of functioning.|From Cycle 1 to 14, as of 05 December 2014.|The PRO –evaluable population is defined as a subset of ITT participants, who have completed a baseline and at least one post –baseline PRO assessment prior to end of study treatment. Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Units on a scale||95% Confidence Interval|Mean
655985|NCT01941940|Primary|Change From Baseline in CDAI at Week 2|The CDAI is a numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGDA and PGDA assessed on 0-10 cm VAS. Higher scores represent greater affectation due to disease activity. CDAI total score = 0-76. CDAI score </=2.8 indicates disease remission, >2.8 to 10 indicates low disease activity, >10 to 22 indicates moderate disease activity, and >22 indicates high disease activity.|Baseline, Week 2|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.||units on a scale||Standard Deviation|Mean
657721|NCT01916681|Primary|Time to Delivery|Amount of hours that pass between the start of the induction to delivery.|Hours between start of induction to delivery|||Hours||Inter-Quartile Range|Median
655944|NCT01942135|Secondary|Change From Baseline Between Treatment Comparison in EORTC QLQ-C30 Symptom Scale Scores|The EORTC-QLQ-C30 is a 30-item questionnaire composed of five multi-item functional subscales (physical, role, emotional, cognitive , and social functioning), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a global quality of life (QOL) subscale, and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and the financial impact of cancer). The questionnaire employs 28 4-point Likert scales with responses from “not at all” to “very much” and two 7-point Likert scales for global health and overall QOL. Responses to all items are then converted to a 0 to 100 scale. For functional and global QOL scales, higher scores represent a better level of functioning/QOL. For symptom-oriented scales, a higher score represents more severe symptoms. A 10-point or higher change in scores from baseline is considered clinically significant.|From Cycle 1 to 14, as of 05 December 2014.|The PRO –evaluable population is defined as a subset of ITT participants, who have completed a baseline and at least one post –baseline PRO assessment prior to end of study treatment. Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Units on a scale||95% Confidence Interval|Mean
655945|NCT01942135|Secondary|Change From Baseline Between Treatment Comparison in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scale Scores|The EORTC-QLQ-C30 is a 30-item questionnaire composed of five multi-item functional subscales (physical, role, emotional, cognitive , and social functioning), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a global quality of life (QOL) subscale, and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and the financial impact of cancer). The questionnaire employs 28 4-point Likert scales with responses from “not at all” to “very much” and two 7-point Likert scales for global health and overall QOL. Responses to all items are then converted to a 0 to 100 scale. For functional and global QOL scales, higher scores represent a better level of functioning/QOL. For symptom-oriented scales, a higher score represents more severe symptoms. A 10-point or higher change in scores from baseline is considered clinically significant.|From Cycle 1 to 14, as of 05 December 2014.|The PRO –evaluable population is defined as a subset of ITT participants, who have completed a baseline and at least one post –baseline PRO assessment prior to end of study treatment. Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Units on a scale||95% Confidence Interval|Mean
655946|NCT01942135|Secondary|Ctrough for Goserelin|"Cmin for goserelin (if applicable). The method of dispersion applied here is percent coefficient of variation (%CV)."|Cycles 2/ Day 1 and Cycle 3/ Day 1|All participants who had PK blood samples collected for palbociclib and had at least one measured plasma drug concentration.||pg/mL||Geometric Coefficient of Variation|Geometric Mean
655947|NCT01942135|Secondary|Ctrough for Fulvestrant|"Ctrough for Fulvestrant (if applicable). The method of dispersion applied here is percent coefficient of variation (%CV)."|Cycles 2/Day 1 and Cycle 3/Day 1|All participants who had PK blood samples collected for palbociclib and had at least one measured plasma drug concentration.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
655948|NCT01942135|Secondary|Observed Plasma Trough Concentration (Ctrough) for Palbociclib|"Ctrough for palbociclib (if applicable). The method of dispersion applied here is percent coefficient of variation (%CV)."|Cycle 1/Day 15 and Cycle 2/Day 15|All participants who had PK blood samples collected for palbociclib and had at least one measured plasma drug concentration.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
655949|NCT01942135|Secondary|Survival Probabilities at Months 12, 24 and 36|One-, Two- or Three-year Survival Probability is defined as the probability of survival 1 year, 2 or 3 years after the date of randomization based on the Kaplan-Meier estimate. Survival time was censored to last date the participant is known to be alive.|From randomization until death (assessed up to 36 months)|The ITT population or full analysis set included all participants who were randomized, with study medication, regardless of whether participants received the study medication or received a different drug from that to which they were randomized.||percentage of participants||95% Confidence Interval|Number
655950|NCT01942135|Secondary|Clinical Benefit Response (CBR)|CBR is defined as the overall complete response (CR), partial response (PR) , or stable disease (SD) ≥24 weeks according to the RECIST version 1.1. Clinical Benefit Response Rate (CBRR) is defined as the proportion of participants with CR, PR, or SD ≥24 weeks relative to all randomized participants and randomized participants with measurable disease at baseline. Participants who do not have on-study radiographic tumor re-evaluation, who received antitumor treatment other than the study medication prior to reaching a CR or PR, a best response of SD ≥24 weeks, or who died, progressed, or dropped out for any reason prior to reaching a CR or PR and a best response of SD ≥24 weeks was counted as non-responders in the assessment of CBR. Per RECIST v1.1 for target lesions and assessed by MRI: CR, disappearance of all target lesions; PR, ≥30% decrease in the sum of the longest diameter of target lesions; OR = CR + PR.|From randomization until end of treatment (assessed up to 12 months)|The ITT population or full analysis set included all participants who were randomized, with study medication, regardless of whether participants received the study medication or received a different drug from that to which they were randomized. Randomized participants with measurable disease at baseline was also included.||percentage of participants||95% Confidence Interval|Number
655951|NCT01942135|Secondary|Duration of Response (DR)|DR is defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of disease progression or to death due to any cause, whichever occurs first. If tumor progression data included more than 1 date, the first date was used. DR was calculated as [the date response ended (ie, date of PD or death) – first CR or PR date + 1)]/30.4. Kaplan-Meier estimate of median of the DR is provided below. No inferential statistical analysis were done for DR. The DR was only calculated for the participants with a CR or PR.|From randomization until end of treatment (assessed up to 12 months)|The ITT population or full analysis set included all participants who were randomized, with study medication, regardless of whether participants received the study medication or received a different drug from that to which they were randomized.||Months||95% Confidence Interval|Median
656089|NCT01940341|Other Pre-specified|Percentage of Participants With Treatment-emergent Proteinuria by Urinalysis (Dipstick) Through Week 48|Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method.|Up to 48 weeks|Participants in the Safety Analysis Set with at least 1 postbaseline urine protein value were analyzed.||percentage of participants|||Number
655952|NCT01942135|Secondary|Objective Response (OR)|OR is defined as the overall complete response (CR) or partial response (PR) according to the RECIST version 1.1 Objective Response Rate (ORR) is defined as the proportion of participants with CR or PR relative to all randomized participants and randomized participants with measurable disease at baseline. Participants who do not have on-study radiographic tumor re-evaluation, who received anti-tumor treatment other than the study medication prior to reaching a CR or PR, or who died, progressed, or dropped out for any reason prior to reaching a CR or PR were counted as non-responders in the assessment of ORR. Per response evaluation criteria in solid tumors criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), ≥30% decrease in the sum of the longest diameter of target lesions (longest for non-nodal and short axis for nodal target lesions); Overall Response (OR) = CR + PR.|From randomization until end of treatment (assessed up to 12 months)|The ITT population or full analysis set included all participants who were randomized, with study medication, regardless of whether participants received the study medication or received a different drug from that to which they were randomized. Randomized participants with measurable disease at baseline was also included.||percentage of participants||95% Confidence Interval|Number
655953|NCT01942135|Secondary|Overall Survival (OS) - Number of Participants Who Died|OS is defined as the time from date of randomization to date of death due to any cause. In the absence of confirmation of death, survival time was censored to last date the participant was known to be alive. For participants lacking survival data beyond the date of their last follow-up, the OS time was censored on the last date they were known to be alive. Participants lacking survival data beyond randomization were to have their OS times be censored at randomization. The length of OS was calculated as OS time (months) = [death date (censor date) – randomization date + 1]/30.4. No inferential statistical analysis were done because of the immaturity of the OS data.|From randomization until death (up to approximately 36 months)|The ITT population or full analysis set included all participants who were randomized, with study medication, regardless of whether participants received the study medication or received a different drug from that to which they were randomized.||deaths|||Number
655954|NCT01942135|Primary|Progression-Free Survival (PFS) as Assessed by the Investigator|PFS is the time from the date of randomization to the date of the first documentation of objective progression of disease (PD)or death due to any cause in absence of documented PD. Participants lacking an evaluation of tumor response after randomization had their PFS time censored on the date of randomization with the duration of a day. Participants with documentation of PD or death after a long interval (2 or more incomplete or non-evaluable assessments) since the last tumor assessment were censored at the time of last objective assessment that did not show PD. The length of PFS was calculated as PFS time (months) =[progression/death date(censor date) - randomization date + 1]/30.4. Progression is defined using Response Evaluation Criteria in Solid Tumors(RECIST v1.1) a 20% increase in the sum of diameters of target lesions and the sum must also demonstrate an absolute increase of at least 5mm or unequivocal progression of existing non-target lesions or the appearance of new lesions.|From randomization date to date of first documentation of progression or death (assessed up to 12 months)|The intent-to-treat (ITT) population or full analysis set included all participants who were randomized, with study medication, regardless of whether participants received the study medication or received a different drug from that to which they were randomized.||Months||95% Confidence Interval|Median
655955|NCT01941940|Secondary|Mean Soluble Interleukin-6 Receptor (sIL-6R) Concentration||Baseline, Weeks 12, 24, 38, 52, at early withdrawal (up to Week 52), at Follow-up Visit 2 (Week 76)|FAS; Here 'n' signifies the number of participants evaluable at specified time point.||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
655956|NCT01941940|Secondary|Mean Tocilizumab Concentration||Baseline, Weeks 12, 24, 38, 52, at early withdrawal (up to Week 52), at Follow-up Visit 2 (Week 76)|FAS; Here 'n' signifies the number of participants evaluable at specified time point.||micrograms per milliliter (mcg/mL)||Standard Deviation|Mean
655957|NCT01941940|Secondary|Percentage of Participants With Anti-Therapeutic Antibodies (ATA) to Tocilizumab|Percentage of participants with positive results for ATA against tocilizumab at different time points is reported.|Baseline, Weeks 12, 24, 38, 52, at 8 weeks after last dose (up to Week 60), at early withdrawal (up to Week 52), at Follow-up Visits 1 (Week 64), 2 (Week 76), and 3 (Week 88)|FAS; Here, 'n' signifies the number of participants evaluable at specified time point.||percentage of participants|||Number
655958|NCT01941940|Secondary|Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) of Special Interest|An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs are AEs occurring between the first dose of study drug and up to 28 days after the last dose that were absent before treatment or that worsened relative to pre-treatment state. Following AEs were considered as AEs of special interest: anaphylactic reaction, hypersensitivity, stress cardiomyopathy, Gilbert’s syndrome, gastrointestinal perforation, injection site erythema, injection site hypersensitivity, injection site irritation, injection site pruritus, arthritis bacterial, cellulitis, klebsiella infection, oral candidiasis, pneumonia, skin infection, vulvovaginal candidiasis, alanine aminotransferase increased, hepatic enzyme increased, brain neoplasm malignant, and urticaria.|Baseline up to 95 weeks|FAS||percentage of participants|||Number
655959|NCT01941940|Secondary|Treatment Compliance, as Assessed Using Participant Diary Cards and Return Records|Treatment Compliance was calculated as (total actual doses taken for the period) / (total planned or prescribed dose for the period) x 100.|Weeks 24 and 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.||percentage of planned dose||Standard Deviation|Mean
655960|NCT01941940|Secondary|Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) at Weeks 24 and 52|PSQI is a questionnaire with 18 questions to assess sleep quality. The 18 questions are distributed to 7 elements (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction). A participant indicates how frequently each item was experienced on a scale from 0 to 3. The global score is the sum score of all 7 elements and ranges from 0-21 with higher values indicating worse sleep quality. A score of >/=5 indicates poor sleepers.|Baseline, Weeks 24 and 52|Per-protocol analysis set (PPAS) included all participants in FAS without any major protocol violation and who completed 24 weeks of treatment period. 'Overall Number of Participants Analyzed'=participants evaluable for this outcome; 'n'=participants evaluable at specified time point.||units on a scale||Standard Deviation|Mean
655961|NCT01941940|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Total Score at Weeks 2, 24, and 52|FACIT total score is sum of Functional Assessment of Cancer Therapy-General (FACT-G) score and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F; additional concerns) score. FACT-G is a core questionnaire that evaluates quality of life (QoL) in cancer population. FACT-G consists of 27 questions grouped in 4 domains of general health-related QoL: physical well-being, social/family well-being, emotional well-being, and functional well-being; each item ranges from 0 (not at all) to 4 (very much). FACT-G score ranges between 0-108. FACIT-F is a 13-item questionnaire that evaluates self-reported fatigue and its impact upon daily activities. Each item ranges from 0 (Not at all) to 4 (Very much). The sum of all responses result in the FACIT total score with a total possible range of 0 (better score) to 160 (worse score). Negative change from baseline represents a better QoL.|Baseline, Weeks 2, 24, and 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.||units on a scale||Standard Deviation|Mean
655962|NCT01941940|Secondary|Missed Working Days Assessed Using Short Form-Health and Labor Questionnaire (SF-HLQ) Score at Weeks 24 and 52|The SF-HLQ assessed productivity losses related to health problems in individuals with paid or unpaid work and consisted of three modules (absenteeism from paid work, production losses without absenteeism from paid work and hindrance in the performance of paid and unpaid work). Any missed working days or number of worked days with reduced efficiency during the last month were reported.|Weeks 24 and 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.||days||Standard Deviation|Mean
655963|NCT01941940|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 24, and 52|HAQ-DI is a participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Weeks 2, 24, and 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.||units on a scale||Standard Deviation|Mean
655964|NCT01941940|Secondary|Participant Pain VAS Score at Weeks 2, 24, and 52|Participants assessed their pain using a 0-100 mm VAS. Intensity of pain range (over past week): 0 mm = no pain to 100 mm = worst possible pain.|Weeks 2, 24, and 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.||mm||Standard Deviation|Mean
655965|NCT01941940|Secondary|Change From Baseline in PGDA VAS Score at Weeks 2, 24, and 52|The physician assessed participant's current disease activity on a 0-100 mm VAS, where 0 mm = no disease activity and 100 mm = maximum disease activity.|Baseline, Weeks 2, 24, and 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.||mm||Standard Deviation|Mean
655966|NCT01941940|Secondary|Change From Baseline in PtGDA VAS Score at Weeks 2, 24, and 52|"Participants answered the following question: Considering all the ways your arthritis affects you, how are you feeling today. Participants responded by using a 0 - 100 millimeter (mm) VAS, where 0 mm = very well and 100 mm = very poorly."|Baseline, Weeks 2, 24, and 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.||mm||Standard Deviation|Mean
655967|NCT01941940|Secondary|Percentage of Non-DMARDs Dose Reductions and/or Discontinuation Events by Reasons|Percentage of Non-DMARDs dose reduction and/or discontinuation (Red/Dis) events is reported by different reasons.|Baseline up to Week 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants with non-DMARDs dose reductions and/or discontinuation.||percentage of events|Non-DMARDs Dose Red/Dis Events||Number
655968|NCT01941940|Secondary|Percentage of DMARDs Dose Reductions and/or Discontinuation Events by Reasons|Percentage of DMARDs dose reduction and/or discontinuation (Red/Dis) events is reported by different reasons.|Baseline up to Week 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants with DMARDs dose reductions and/or discontinuation.||percentage of events|DMARDs Dose Red/Dis Events||Number
655969|NCT01941940|Secondary|Association Between Disease Activity Parameter (SDAI) and Treatment Response Parameter (EULAR), Assessed Using Regression Coefficient|The SDAI is a numerical sum of 5 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGDA and PGDA assessed on 0-10 cm VAS and CRP in mg/dL. SDAI total score= 0-86. EULAR response criteria (based on DAS28 score): Good responders (change from baseline >1.2 with DAS28 </=3.2); Moderate responders (change from baseline >1.2 with DAS28 >3.2 to </=5.1 or change from baseline >0.6 to </=1.2 with DAS28 </=5.1); Non-responders (change from baseline </=0.6 or change from baseline >0.6 and </=1.2 with DAS28 >5.1). Regression coefficient for relationship between SDAI and EULAR Good response at different time points is reported. Regression coefficient value range= not defined (any negative or positive value is possible). Higher positive value indicates greater extent of positive relationship and higher negative value indicates greater extent of negative relationship.|Weeks 2, 24, 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.||regression coefficient|||Number
655986|NCT01941940|Primary|Change From Baseline in CDAI at Week 4|The CDAI is a numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGDA and PGDA assessed on 0-10 cm VAS. Higher scores represent greater affectation due to disease activity. CDAI total score = 0-76. CDAI score </=2.8 indicates disease remission, >2.8 to 10 indicates low disease activity, >10 to 22 indicates moderate disease activity, and >22 indicates high disease activity.|Baseline, Week 4|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.||units on a scale||Standard Deviation|Mean
656127|NCT01940120|Other Pre-specified|Incidence of New Coumadin Use|New onset use of Coumadin or warfarin to treat a potential thrombus on a defibrillator lead.|6 months|49 patients not on coumadin at baseline are included in the analysis.||participants|||Number
655970|NCT01941940|Secondary|Association Between Disease Activity Parameter (SDAI) and Treatment Response Parameters (ACR20, ACR50, and ACR70), Assessed Using Regression Coefficient|SDAI is a numerical sum of 5 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGDA and PGDA assessed on 0-10 cm VAS and CRP in mg/dL. SDAI total score= 0-86. The ACR 20, 50, and 70 responses: >/=20%, 50%, and 70% improvement in TJC and SJC, and 20%, 50%, 70% improvement in 3 of the following 5 criteria, respectively: 1) PGDA, 2) PtGDA, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) CRP at each visit. Regression coefficients for relationship between SDAI and ACR responses (ACR20, ACR50, and ACR70) at different time points are reported. Regression coefficient value range= not defined (any negative or positive value is possible). Higher positive value indicates greater extent of positive relationship and higher negative value indicates greater extent of negative relationship.|Weeks 2, 24, 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.||regression coefficient|||Number
655971|NCT01941940|Secondary|Association Between Disease Activity Parameter (CDAI) and Treatment Response Parameter (EULAR), Assessed Using Regression Coefficient|The CDAI is a numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGDA and PGDA assessed on 0-10 cm VAS. CDAI total score = 0-76. EULAR response criteria (based on DAS28 score): Good responders (change from baseline >1.2 with DAS28 </=3.2); Moderate responders (change from baseline >1.2 with DAS28 >3.2 to </=5.1 or change from baseline >0.6 to </=1.2 with DAS28 </=5.1); Non-responders (change from baseline </=0.6 or change from baseline >0.6 and </=1.2 with DAS28 >5.1). Regression coefficient for relationship between CDAI and EULAR Good response at different time points is reported. Regression coefficient value range= not defined (any negative or positive value is possible). Higher positive value indicates greater extent of positive relationship and higher negative value indicates greater extent of negative relationship.|Weeks 2, 24, 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.||regression coefficient|||Number
655972|NCT01941940|Secondary|Association Between Disease Activity Parameter (CDAI) and Treatment Response Parameters (ACR20, ACR50, and ACR70), Assessed Using Regression Coefficient|The CDAI is a numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGDA and PGDA assessed on 0-10 cm VAS. CDAI total score = 0-76. The ACR 20, 50, and 70 responses: >/=20%, 50%, and 70% improvement in TJC and SJC, and 20%, 50%, 70% improvement in 3 of the following 5 criteria, respectively: 1) PGDA, 2) PtGDA, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) CRP at each visit. Regression coefficients for relationship between CDAI and ACR responses (ACR20, ACR50, and ACR70) at different time points are reported. Regression coefficient value range= not defined (any negative or positive value is possible). Higher positive value indicates greater extent of positive relationship and higher negative value indicates greater extent of negative relationship.|Weeks 2, 24, 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.||regression coefficient|||Number
655973|NCT01941940|Secondary|Association Between Disease Activity Parameter (DAS28-ESR) and Treatment Response Parameter (EULAR), Assessed Using Regression Coefficient|DAS28-ESR is calculated from the TJC and SJC based on a 28-joint assessment, the ESR in mm/hour and PtGDA. DAS28-ESR total score= 0-9.4. EULAR response criteria (based on DAS28 score): Good responders (change from baseline >1.2 with DAS28 </=3.2); Moderate responders (change from baseline >1.2 with DAS28 >3.2 to </=5.1 or change from baseline >0.6 to </=1.2 with DAS28 </=5.1); Non-responders (change from baseline </=0.6 or change from baseline >0.6 and </=1.2 with DAS28 >5.1). Regression coefficient for relationship between DAS28-ESR and EULAR Good response at different time points is reported. Regression coefficient value range= not defined (any negative or positive value is possible). Higher positive value indicates greater extent of positive relationship and higher negative value indicates greater extent of negative relationship.|Weeks 2, 24, 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.||regression coefficient|||Number
655974|NCT01941940|Secondary|Association Between Disease Activity Parameter (DAS28-ESR) and Treatment Response Parameters (ACR20, ACR50, and ACR70), Assessed Using Regression Coefficient|DAS28-ESR is calculated from the TJC and SJC based on a 28-joint assessment, the ESR in mm/hour and PtGDA. DAS28-ESR total score= 0-9.4. The ACR 20, 50, and 70 responses: >/=20%, 50%, and 70% improvement in TJC and SJC, and 20%, 50%, 70% improvement in 3 of the following 5 criteria, respectively: 1) PGDA, 2) PtGDA, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) CRP at each visit. Regression coefficients for relationship between DAS28-ESR and ACR responses (ACR20, ACR50, and ACR70) at different time points are reported. Regression coefficient value range= not defined (any negative or positive value is possible). Higher positive value indicates greater extent of positive relationship and higher negative value indicates greater extent of negative relationship.|Weeks 2, 24, 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.||regression coefficient|||Number
655975|NCT01941940|Secondary|Association Between Disease Activity Parameters: CDAI and SDAI, Assessed Using Correlation Coefficient|The CDAI is a numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGDA and PGDA assessed on 0-10 cm VAS. CDAI total score = 0-76. Higher scores represent greater affectation due to disease activity. SDAI is a numerical sum of 5 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGDA and PGDA assessed on 0-10 cm VAS and CRP in mg/dL. SDAI total score= 0-86. Higher scores indicate greater affectation due to disease activity. Correlation coefficient for relationship between CDAI and SDAI at different time points is reported. Correlation coefficient value range= -1 to 1. Higher positive value indicates greater positive relationship and higher negative value indicates greater negative relationship.|Weeks 2, 24, 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.||correlation coefficient|||Number
656128|NCT01940120|Other Pre-specified|Incidence of New Coumadin Use|New onset use of Coumadin or warfarin to treat a potential thrombus on a defibrillator lead.|30 days|49 patients not on coumadin at baseline are included in the analysis.||participants|||Number
655976|NCT01941940|Secondary|Association Between Disease Activity Parameters: DAS28-ESR and SDAI, Assessed Using Correlation Coefficient|DAS28-ESR is calculated from the TJC and SJC based on a 28-joint assessment, the ESR in mm/hour and PtGDA. DAS28-ESR total score= 0-9.4. Higher scores indicate greater affectation due to disease activity. SDAI is a numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGDA and PGDA assessed on 0-10 cm VAS and CRP in mg/dL. SDAI total score= 0-86. Higher scores indicate greater affectation due to disease activity. Correlation coefficient for relationship between DAS28-ESR and SDAI at different time points is reported. Correlation coefficient value range= -1 to 1. Higher positive value indicates greater positive relationship and higher negative value indicates greater negative relationship.|Weeks 2, 24, 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.||correlation coefficient|||Number
655977|NCT01941940|Secondary|Association Between Disease Activity Parameters: DAS28-ESR and CDAI, Assessed Using Correlation Coefficient|DAS28-ESR is calculated from the TJC and SJC based on a 28-joint assessment, the ESR in mm/hour and PtGDA. DAS28-ESR total score= 0-9.4. Higher scores indicate greater affectation due to disease activity. The CDAI is a numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGDA and PGDA assessed on 0-10 cm VAS. CDAI total score = 0-76. Higher scores represent greater affectation due to disease activity. Correlation coefficient for relationship between DAS28-ESR and CDAI at different time points is reported. Correlation coefficient value range= -1 to 1. Higher positive value indicates greater positive relationship and higher negative value indicates greater negative relationship.|Weeks 2, 24, 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.||correlation coefficient|||Number
655978|NCT01941940|Secondary|Change From Baseline in Total SJC at Weeks 2, 24, and 52|SJC was defined as the total number of swollen joints based on 66-joint assessment (SJC-66) and 28-joint assessment (SJC-28).|Baseline, Weeks 2, 24, and 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.||swollen joints||Standard Deviation|Mean
655979|NCT01941940|Secondary|Change From Baseline in Total TJC at Weeks 2, 24, and 52|TJC was defined as the total number of painful joints based on 68-joint assessment (TJC-68) and 28-joint assessment (TJC-28).|Baseline, Weeks 2, 24, and 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.||tender joints||Standard Deviation|Mean
655980|NCT01941940|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28|The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 </=3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to </=5.1 or change from baseline >0.6 to </=1.2 with DAS28 </=5.1; non-responders: change from baseline </=0.6 or change from baseline >0.6 and </=1.2 with DAS28 >5.1.|Baseline, Weeks 2, 24, and 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.||percentage of participants|||Number
655981|NCT01941940|Secondary|Percentage of Participants With an American College of Rheumatology 20% (ACR20), 50% (ACR50), and 70% (ACR70) Response|The ACR 20, 50, and 70 responses: greater than or equal to (>/=) 20 percent (%), 50%, and 70% improvement in TJC and SJC (28 assessed joints), and 20%, 50%, 70% improvement in 3 of the following 5 criteria, respectively: 1) PGDA, 2) PtGDA, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) CRP or ESR at each visit.|Weeks 2, 24, and 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.||percentage of participants|||Number
655982|NCT01941940|Secondary|Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 24, and 52|SDAI is a numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGDA and PGDA assessed on 0-10 cm VAS and C-reactive protein (CRP) in milligrams per deciliter (mg/dL). Higher scores indicate greater affectation due to disease activity. SDAI total score = 0-86. SDAI </=3.3 indicates disease remission, >3.4 to 11 indicates low disease activity, >11 to 26 indicates moderate disease activity, and >26 indicates high disease activity.|Baseline, Weeks 2, 24, and 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.||units on a scale||Standard Deviation|Mean
655983|NCT01941940|Secondary|Change From Baseline in Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (DAS28-ESR) at Weeks 2, 24, and 52|DAS28-ESR is calculated from the TJC and SJC based on a 28-joint assessment, the erythrocyte sedimentation rate (ESR) in millimeters per hour (mm/hour) and PtGDA assessed on 0-10 cm VAS. Higher scores indicate greater affectation due to disease activity. DAS28-ESR total score= 0-9.4. DAS28-ESR </=3.2 indicates low disease activity, DAS28-ESR >3.2 to 5.1 indicates moderate to high disease activity, and DAS28-ESR </=3.2 indicates remission.|Baseline, Weeks 2, 24, and 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.||units on a scale||Standard Deviation|Mean
655984|NCT01941940|Secondary|Number of Participants Achieving Clinical Remission According to CDAI up to Week 52|The CDAI is a numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGDA and PGDA assessed on 0-10 cm VAS. Higher scores represent greater affectation due to disease activity. CDAI total score = 0-76. CDAI score </=2.8 during any two consecutive visits, not including the baseline visit indicates disease remission.|Baseline up to Week 52 (Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 38, and 52)|FAS||participants|||Number
656012|NCT01941485|Secondary|Corneal Topography: Angles|The angles (angular measurement of the space between the iris and the lens) were assessed using a commercially available system. The higher the value, the bigger the space.|Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative|"This analysis population includes all subjects with 1 day post-operation measurements of the corneal topography endpoint. Here, n includes all eyes with data."||degrees|Eyes|Standard Deviation|Mean
655987|NCT01941940|Primary|Change From Baseline in CDAI at Week 8|The CDAI is a numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGDA and PGDA assessed on 0-10 cm VAS. Higher scores represent greater affectation due to disease activity. CDAI total score = 0-76. CDAI score </=2.8 indicates disease remission, >2.8 to 10 indicates low disease activity, >10 to 22 indicates moderate disease activity, and >22 indicates high disease activity.|Baseline, Week 8|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.||units on a scale||Standard Deviation|Mean
655988|NCT01941940|Primary|Change From Baseline in CDAI at Week 12|The CDAI is a numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGDA and PGDA assessed on 0-10 cm VAS. Higher scores represent greater affectation due to disease activity. CDAI total score = 0-76. CDAI score </=2.8 indicates disease remission, >2.8 to 10 indicates low disease activity, >10 to 22 indicates moderate disease activity, and >22 indicates high disease activity.|Baseline, Week 12|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.||units on a scale||Standard Deviation|Mean
655989|NCT01941940|Primary|Change From Baseline in CDAI at Week 16|The CDAI is a numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGDA and PGDA assessed on 0-10 cm VAS. Higher scores represent greater affectation due to disease activity. CDAI total score = 0-76. CDAI score </=2.8 indicates disease remission, >2.8 to 10 indicates low disease activity, >10 to 22 indicates moderate disease activity, and >22 indicates high disease activity.|Baseline, Week 16|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.||units on a scale||Standard Deviation|Mean
655990|NCT01941940|Primary|Change From Baseline in CDAI at Week 20|The CDAI is a numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGDA and PGDA assessed on 0-10 cm VAS. Higher scores represent greater affectation due to disease activity. CDAI total score = 0-76. CDAI score </=2.8 indicates disease remission, >2.8 to 10 indicates low disease activity, >10 to 22 indicates moderate disease activity, and >22 indicates high disease activity.|Baseline, Week 20|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.||units on a scale||Standard Deviation|Mean
655991|NCT01941940|Primary|Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 24|The CDAI is a numerical sum of 4 outcome parameters: tender joint count (TJC) and swollen joint count (SJC) based on a 28-joint assessment, patient's global assessment of disease activity (PtGDA) and physician global assessment of disease activity (PGDA) assessed on 0-10 centimeters (cm) visual analogue scale (VAS). Higher scores represent greater affectation due to disease activity. CDAI total score = 0-76. CDAI score less than or equal to (</=) 2.8 indicates disease remission, greater than (>) 2.8 to 10 indicates low disease activity, >10 to 22 indicates moderate disease activity, and >22 indicates high disease activity.|Baseline, Week 24|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.||units on a scale||Standard Deviation|Mean
655992|NCT01941615|Primary|C24,ss of Levonogestrel|Measured concentration of levonogestrel in plasma at steady state 24 hours after drug administration.|Visit (V)3: 2 hours(h) pre dose, 240, 264, 288, 288.5, 289, 289.5, 290, 291, 292, 294, 296, 298, 300 h post dose; V4: 0, 24, 48, 72, 96, 120, 144, 168, 192, 216, 216.5, 217, 217.5, 218, 219, 220, 222, 224, 226, 228, 240 h post dose for oral contraceptives|Since this trial was prematurely discontinued during the run-in period, no blood samples for pharmacokinetics were collected and therefore no pharmacokinetic endpoints could be determined.|||||
655993|NCT01941615|Primary|Cmax,ss of Levonogestrel|Maximum measured concentration of levonogestrel in plasma at steady state over a uniform dosing interval t.|Visit (V)3: 2 hours(h) pre dose, 240, 264, 288, 288.5, 289, 289.5, 290, 291, 292, 294, 296, 298, 300 h post dose; V4: 0, 24, 48, 72, 96, 120, 144, 168, 192, 216, 216.5, 217, 217.5, 218, 219, 220, 222, 224, 226, 228, 240 h post dose for oral contraceptives|Since this trial was prematurely discontinued during the run-in period, no blood samples for pharmacokinetics were collected and therefore no pharmacokinetic endpoints could be determined.|||||
655994|NCT01941615|Primary|AUCtau,ss of Levonogestrel|Area under the concentration-time curve of levonogestrel in plasma at steady state over a uniform dosing interval t.|Visit (V)3: 2 hours(h) pre dose, 240, 264, 288, 288.5, 289, 289.5, 290, 291, 292, 294, 296, 298, 300 h post dose; V4: 0, 24, 48, 72, 96, 120, 144, 168, 192, 216, 216.5, 217, 217.5, 218, 219, 220, 222, 224, 226, 228, 240 h post dose for oral contraceptives|Since this trial was prematurely discontinued during the run-in period, no blood samples for pharmacokinetics were collected and therefore no pharmacokinetic endpoints could be determined.|||||
655995|NCT01941615|Primary|C24,ss of Ethinylestradiol|Measured concentration of ethinylestradiol in plasma at steady state 24 hours after drug administration.|Visit (V)3: 2 hours(h) pre dose, 240, 264, 288, 288.5, 289, 289.5, 290, 291, 292, 294, 296, 298, 300 h post dose; V4: 0, 24, 48, 72, 96, 120, 144, 168, 192, 216, 216.5, 217, 217.5, 218, 219, 220, 222, 224, 226, 228, 240 h post dose for oral contraceptives|Since this trial was prematurely discontinued during the run-in period, no blood samples for pharmacokinetics were collected and therefore no pharmacokinetic endpoints could be determined.|||||
655996|NCT01941615|Primary|Cmax,ss of Ethinylestradiol|Maximum measured concentration of ethinylestradiol in plasma at steady state over a uniform dosing interval t|Visit (V)3: 2 hours(h) pre dose, 240, 264, 288, 288.5, 289, 289.5, 290, 291, 292, 294, 296, 298, 300 h post dose; V4: 0, 24, 48, 72, 96, 120, 144, 168, 192, 216, 216.5, 217, 217.5, 218, 219, 220, 222, 224, 226, 228, 240 h post dose for oral contraceptives|Since this trial was prematurely discontinued during the run-in period, no blood samples for pharmacokinetics were collected and therefore no pharmacokinetic endpoints could be determined.|||||
655997|NCT01941615|Primary|AUCtau,ss of Ethinylestradiol|Area under the concentration-time curve of ethinylestradiol in plasma at steady state over a uniform dosing interval t (AUCtau,ss).|Visit (V)3: 2 hours(h) pre dose, 240, 264, 288, 288.5, 289, 289.5, 290, 291, 292, 294, 296, 298, 300 h post dose; V4: 0, 24, 48, 72, 96, 120, 144, 168, 192, 216, 216.5, 217, 217.5, 218, 219, 220, 222, 224, 226, 228, 240 h post dose for oral contraceptives|Since this trial was prematurely discontinued during the run-in period, no blood samples for pharmacokinetics were collected and therefore no pharmacokinetic endpoints could be determined.|||||
655998|NCT01941498|Secondary|Corneal Curvature as Measured by Keratometry|Corneal curvature was assessed by a commercially available system and measured in diopters.|Baseline (Day 0), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative|This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point.||diopter||Standard Deviation|Mean
655999|NCT01941498|Secondary|Wavefront Aberrometry|Wavefront aberrations (optical imperfections of the eye that prevent light from focusing perfectly on the retina, resulting in defects in the visual image) were measured using a commercially available system. Higher order aberrations (i.e., spherical aberrations, coma, and trifoil) are defined as optical imperfections which cannot be corrected by any reliable means of present technology.|Baseline (Day 0), Month 6 Postoperative|This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint.||microns||Standard Deviation|Mean
656000|NCT01941498|Secondary|Mean Contrast Sensitivity (CS)|Contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly with distance manifest correction in place and uncorrected. Contrast sensitivity was assessed at spatial frequencies of 3, 6, 12, and 18 cycles per degree (cpd), where 3.0 cpd = A, 6.0 cpd = B, 12.0 cpd = C, and 18.0 cpd = D. Raw scores were log transformed. A higher numeric value represents better contrast sensitivity.|Baseline (Day 0), Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative|"This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint. Here, n is the number of subjects assessed uncorrected."||logCS||Standard Deviation|Mean
656001|NCT01941498|Secondary|"Percent Response by Category: Driving at Night"|"As recorded by the subject on the RSVP questionnaire, where 0 is Not applicable, 1 is No difficulty at all, 2 is A little difficulty, 3 is Moderate difficulty, 4 is Severe difficulty and 5 is So much difficulty that I did not do the activity with this alternative."|Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative|This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point.||percentage of subjects|||Number
656002|NCT01941498|Secondary|"Percent Response by Category: My Vision Is a Concern in My Daily Life"|As recorded by the subject on the RSVP questionnaire|Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative|This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point.||percentage of subjects|||Number
656003|NCT01941498|Secondary|"Percent Response by Category: I Worry About my Vision"|As recorded by the subject on the RSVP questionnaire|Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative|This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point.||percentage of subjects|||Number
656004|NCT01941498|Secondary|"Percent Response by Category: In the Past 4 Weeks, to See Far Away, I Wore..."|As recorded by the subject on the RSVP questionnaire, where n/a means no use of glasses or contact lenses.|Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative|This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point.||percentage of subjects|||Number
656005|NCT01941498|Secondary|"Mean Response: Rate Your Vision, Over the Past 4 Weeks, With NO Glasses or Contact Lenses"|As recorded by the subject on the the Refractive Status and Vision Profile (RSVP), a self-reported questionnaire used to measure vision-related health status in persons with refractive error, on a scale from 0 (completely blind) to 10 (perfect vision).|Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative|This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point.||units on a scale||Standard Deviation|Mean
656006|NCT01941498|Secondary|Mean Total Laser Treatment Time|Total treatment time with Excimer EX500 and Femtosecond FS200 lasers, measured in seconds. Total duration for both eyes was calculated as sum of duration for the right eye and left eye.|Day 0 (surgery)|This analysis group includes all participants with 1 month post-operative measurement of the primary efficacy endpoint.||seconds||Standard Deviation|Mean
656007|NCT01941498|Secondary|Mean Laser Treatment Time|Treatment time with Excimer EX500 and Femtosecond FS200 lasers, measured in seconds.|Day 0 (surgery)|This analysis group includes all participants with 1 month post-operative measurement of the primary efficacy endpoint.||seconds||Standard Deviation|Mean
656008|NCT01941498|Secondary|Mean Manifest Refraction (Cylinder)|Manifest refraction was performed under photopic lighting conditions using an ETDRS chart at 4 meters. The subject was manually refracted to his/her best correction using a phoropter. Each eye individually contributed to the mean.|Baseline (Day 0), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative|This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point.||diopter|Participants|Standard Deviation|Mean
656009|NCT01941498|Secondary|Mean Manifest Refraction (Sphere)|Manifest refraction was performed under photopic lighting conditions using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart at 4 meters. The subject was manually refracted to his/her best correction using a phoropter. Each eye individually contributed to the mean.|Baseline (Day 0), Operation/Surgery (Day 1), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative|This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point.||diopter|Participants|Standard Deviation|Mean
656010|NCT01941498|Secondary|Mean Difference Between Achieved and Target Corneal Flap Thickness as Assessed by OCT|The expected flap thickness as determined pre-operatively was subtracted from the achieved flap thickness as assessed by optical coherence tomography (OCT) (ie, an imaging method using light to capture three-dimensional images). A positive number represents a postoperative flap thickness that is thicker than the expected flap thickness and vice versa for a negative number.|Operation/Surgery (Day 1), Month 1 Postoperative, Month 6 Postoperative|This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point.||microns||Standard Deviation|Mean
656011|NCT01941498|Primary|Least Squares Mean Difference in Binocular UCVA at 1 Month Post-Treatment and Pre-Treatment Binocular BCVA|Visual acuity (VA) with corrective devices (BCVA) was assessed binocularly (both eyes together) pre-treatment and subtracted from VA without spectacles or other visual corrective devices (UCVA) assessed binocularly at 1 month post-treatment. VA was measured at a distance of 4 meters and reported in logMAR (logarithm of the minimum angle of resolution), with 0.00 logMAR corresponding to 20/20 Snellen. A negative value indicates an improvement in VA from pre-treatment to Month 1.|Month 1|This analysis population includes all participants with 1 month post-operative measurement of the primary efficacy endpoint.||logMAR||Standard Error|Least Squares Mean
657722|NCT01916629|Primary|Percent Lesion Clearance||90 days|||Percent Clearance||Standard Deviation|Mean
656013|NCT01941485|Secondary|Corneal Topography: Anterior Chamber (AC) Depth|The AC depth (axial distance between the anterior surface of the cornea and the anterior surface of the lens) was assessed using a commercially available system. A higher value represents a longer distance.|Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative|"This analysis population includes all subjects with 1 day post-operation measurements of the corneal topography endpoint. Here, n includes all eyes with data."||millimeters|Eyes|Standard Deviation|Mean
656014|NCT01941485|Secondary|Corneal Topography: Anterior Chamber (AC) Volume|The AC volume (a measure of the shallowness of the anterior chamber) was assessed using a commercially available system. The lower the chamber volume, the more shallow the anterior chamber or the chamber angle.|Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative|"This analysis population includes all subjects with 1 day post-operation measurements of the corneal topography endpoint. Here, n includes all eyes with data."||millimeters cubed|Eyes|Standard Deviation|Mean
656015|NCT01941485|Secondary|Corneal Topography: Q-value|The Q-value (a measure of corneal asphericity) was assessed using a commercially available system. The Q-values are negative (−1 < Q < 0) for prolate corneas, in which the central curvature is steeper than the peripheral curvature, and positive (Q > 0) for oblate corneas, in which the central curvature is flatter than the peripheral curvature.|Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative|"This analysis population includes all subjects with 1 day post-operation measurements of the corneal topography endpoint. Here, n includes all eyes with data."||unit less|Eyes|Standard Deviation|Mean
656016|NCT01941485|Secondary|Flap Creation Time as Documented in the Log Files|The time to create the flap with FS200 Femtosecond Flap Creation System, measured in seconds.|Operation/Surgery (Day 1)|This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.||seconds||Standard Deviation|Mean
656017|NCT01941485|Secondary|Corneal Curvature as Measured by Keratometry|Corneal curvature as assessed by a commercially available system and measured in diopters.|Baseline/Screening (Day 0), 1 Month Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative|This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.||diopter||Standard Deviation|Mean
656018|NCT01941485|Secondary|"Percent Response by Category: Driving at Night"|"As recorded by the subject on the RSVP questionnaire, where 0 is Not applicable, 1 is No difficulty at all, 2 is A little difficulty, 3 is Moderate difficulty, 4 is Severe difficulty and 5 is So much difficulty that I did not do the activity with this alternative."|Baseline/Screening (Day 0), Month 1 Postoperative, Month 6 Postoperative, Month 12 Postoperative|This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point.||percentage of subjects|||Number
656019|NCT01941485|Secondary|"Percent Response by Category: My Vision is a Concern in my Daily Life"|As recorded by the subject on the RSVP questionnaire|Baseline/Screening (Day 0), Month 1 Postoperative, Month 6 Postoperative, Month 12 Postoperative|This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.||percentage of subjects|||Number
656020|NCT01941485|Secondary|"Percent Response by Category: I Worry About my Vision"|As recorded by the subject on the RSVP questionnaire|Baseline/Screening (Day 0), Month 1 Postoperative, Month 6 Postoperative, Month 12 Postoperative|This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.||percentage of subjects|||Number
656021|NCT01941485|Secondary|"Percent Response to Have Always Worn Glasses or Contact Lenses in the Past 4 Weeks"|As recorded by the subject on the the Refractive Status and Vision Profile (RSVP), a self-reported questionnaire used to measure vision-related health status in persons with refractive error.|Baseline/Screening (Day 0), Month 1 Postoperative, Month 6 Postoperative, Month 12 Postoperative|This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint.||percentage of subjects|||Number
656022|NCT01941485|Secondary|"Mean Response: Rate Your Vision, Over the Past 4 Weeks, With NO Glasses or Contact Lenses"|As recorded by the subject on the the Refractive Status and Vision Profile (RSVP), a self-reported questionnaire used to measure vision-related health status in persons with refractive error, on a scale from 0 (completely blind) to 10 (perfect vision).|Baseline/Screening (Day 0), Month 1 Postoperative, Month 6 Postoperative, Month 12 Postoperative|This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point.||units on a scale||Standard Deviation|Mean
656023|NCT01941485|Secondary|Wavefront Aberrometry|Wavefront aberrations (optical imperfections of the eye that prevent light from focusing perfectly on the retina, resulting in defects in the visual image) were measured using a commercially available system. Higher order aberrations (i.e., spherical aberrations, coma, and trefoil) are defined as optical imperfections which cannot be corrected by any reliable means of present technology.|Operation/Surgery (Day 1), Month 1 Postoperative, Month 6 Postoperative, Month 12 Postoperative|This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point.||micrometers||Standard Deviation|Mean
656024|NCT01941485|Secondary|Corneal Flap Diameter as Assessed by Ocular Coherence Tomography (OCT)|The diameter of the corneal flap was assessed by OCT (ie. an imaging method using light to capture three-dimensional images). Corneal flap is measured in millimeters.|Operation/Surgery (Day 1), Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative|This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.||millimeters||Standard Deviation|Mean
656025|NCT01941485|Secondary|Mean Contrast Sensitivity (CS)|Contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly with distance manifest correction in place and uncorrected. Contrast sensitivity was assessed at spatial frequencies of 3, 6, 12, and 18 cycles per degree (cpd), where 3.0 cpd = A, 6.0 cpd = B, 12.0 cpd = C, and 18.0 cpd = D. Raw scores were log transformed. A higher numeric value represents better contrast sensitivity. Both eyes contributed to the analysis.|Baseline/Screening (Day 0), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative|This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point.||logCS||Standard Deviation|Mean
656026|NCT01941485|Secondary|Manifest Refraction (Cylinder)|A series of test lenses in graded powers was used to determine which corrective lenses provided the sharpest, clearest vision. Manifest refraction is measured in diopters. Each eye contributed individually to the analysis.|Baseline/Screening (Day 0), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative|This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.||Diopters|eyes|Standard Deviation|Mean
656027|NCT01941485|Secondary|Manifest Refraction (Sphere)|A series of test lenses in graded powers was used to determine which corrective lenses provided the sharpest, clearest vision. Manifest refraction is measured in diopters. Each eye contributed individually to the analysis.|Baseline/Screening (Day 0), Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative|This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.||Diopters|Eyes|Standard Deviation|Mean
656028|NCT01941485|Secondary|Best Corrected Visual Acuity (BCVA)|VA with the subjects's best spectacles or other visual corrective devices, was performed with an ETDRS chart set at a distance of 4 meters. BCVA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.00 logMAR corresponding to 20/20 Snellen. A lower logMAR value indicates better visual acuity.|Baseline/Screening (Day 0), Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative|This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.||logMAR||Standard Deviation|Mean
656029|NCT01941485|Secondary|Uncorrected Visual Acuity (UCVA)|Visual acuity (VA) without spectacles or other visual corrective devices, was performed with an Early Treatment Diabetic Retinopathy Study (ETDRS) chart set at a distance of 4 meters. UCVA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.00 logMAR corresponding to 20/20 Snellen. A lower logMAR value indicates better visual acuity.|Baseline/Screening (Day 0), Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative|This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.||logMAR||Standard Deviation|Mean
656030|NCT01941485|Secondary|The Difference Between Achieved Flap Thickness at Month 1 Post-operative as Assessed by OCT and Expected Flap Thickness as Determined Preoperatively|The expected flap thickness as determined pre-operatively subtracted from the achieved flap thickness at Month 1 postoperative as assessed by optical coherence tomography (ie, an imaging method using light to capture three-dimensional images). Accuracy of flap creation was defined as an achieved thickness within 10 microns of expected thickness.|Month 1 Postoperative|This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point.||microns||Standard Deviation|Mean
656031|NCT01941485|Secondary|Extent of Opaque Bubble Layer (OBL) Within the Femtosecond Flap|The extent of OBL was assessed by digital photo analysis of the area covered by the flap and is reported as the percentage of flap with opaque bubble layer development during femtosecond flap creation.|Operation/Surgery (Day 1)|This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.||percentage of flap||Standard Deviation|Mean
656032|NCT01941485|Secondary|Incidence of Development of Opaque Bubble Layer (OBL)|OBL (the collection of gas bubbles during corneal flap creation) was assessed by digital photo analysis of the area covered by the flap and is reported as the percentage of participants with opaque bubble layer development during femtosecond flap creation.|Operation/Surgery (Day 1)|This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.||percentage of participants|||Number
656033|NCT01941485|Primary|The Difference Between Achieved Flap Thickness at Day 1 Postoperative as Assessed by OCT and Expected Flap Thickness as Determined Pre-operatively|The expected flap thickness as determined pre-operatively was subtracted from the achieved flap thickness at Day 1 postoperative as assessed by optical coherence tomography (ie, an imaging method using light to capture three-dimensional images). Accuracy of flap creation was defined as an achieved thickness within 10 microns of expected thickness.|Day 1 Postoperative|This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.||microns||Standard Deviation|Mean
656034|NCT01941472|Primary|Fluid Responsiveness|Increase in cardiac index ≥ 10% after fluid challenge|Immediately after fluid challenge, average 5 minutes|||Participants|||Count of Participants
656035|NCT01941186|Other Pre-specified|Acceptability of the Patient Decision Aid for Early Intervention Referral|The acceptability of using the patient decision aid for early intervention will be assessed by having patients and providers complete surveys on the intervention.|Up to 7 days|"Provider information was not collected as outlined in the initial protocol design. All survey data is presented collectively in Secondary Outcome Measure, Change in Parental Knowledge and Attitudes From Pre- to Post-Intervention. This includes elements of parent acceptability. A separate analysis was not completed."|||||
656036|NCT01941186|Other Pre-specified|Feasibility of the Patient Decision Aid|The feasibility of the patient decision aid (PDA) will be measured by calculating the number of individuals who refuse to participate, time that it takes to complete the PDA, and the number of patients who complete the Early Intervention referral.|Up to 7 days|Data was not collected regarding the time to complete PDA and/or number of Early Intervention referrals for the total population, thus data for this outcome measure was not able to be analyzed as outlined at the time of protocol development.|||||
656037|NCT01941186|Other Pre-specified|Parental Predisposition for Early Intervention|Parental predisposition for early intervention services will be measured using surveys.|Up to 7 days|"All survey data is presented collectively in Secondary Outcome Measure, Change in Parental Knowledge and Attitudes From Pre- to Post-Intervention. A separate analysis was not completed."|||||
656038|NCT01941186|Other Pre-specified|Parent Uncertainty About Early Intervention|Parental uncertainty about whether to enroll their child in Early Intervention will be evaluated using a survey.|Up to 7 days|"All survey data is presented collectively in Secondary Outcome Measure, Change in Parental Knowledge and Attitudes From Pre- to Post-Intervention. A separate analysis was not completed."|||||
656053|NCT01940510|Secondary|Cmax of RO5468924|Cmax is the maximum observed RO5468924 (the major pharmacologically active metabolite of alectinib) plasma concentration, presented in ng/mL.|Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention period|PK analysis set||ng/mL||Standard Deviation|Mean
656039|NCT01941186|Secondary|Change in Parental Knowledge and Attitudes From Pre- to Post-Intervention|Pre and post knowledge and attitudes regarding developmental delay and early intervention (EI) were assessed by asking participants to respond to 14 statements using a 6 point Likert scale that ranged from strongly disagree to strongly agree. Questions mapped to the video decision aid content viewed by participants. Participants in the intervention arm completed the questions before and after watching the video and participants in the control arm completed the questions sequentially. Secondary outcome measures assessed in the survey included Parent Uncertainty About Early Intervention and Parental Predisposition for Early Intervention.|Up to 7 days|All parent-child dyads who were enrolled and randomized were included in the analysis.||percentage of participants|||Number
656040|NCT01941186|Primary|Difference in the Number of Participants Who Completed Early Intervention Intake and Evaluation Visits Between Treatment Groups|Completed intake and evaluation by the early intervention (EI) agency was assessed by parent report and by chart review. A member of the study team contacted parents within 6 months of the first study visit to obtain this information. Additionally, a chart review seeking written feedback information regarding referral disposition from the EI agency was completed.|Up to 1 year after randomization|One parent-child dyad had missing information regarding EI intake and evaluation. Given the absence of information on referral outcome, this parent-child dyad was included in the final evaluation as having not received an EI intake and evaluation.||participants|||Number
656041|NCT01940523|Secondary|Units of Transfusion|The number of units of perioperative blood transfusions, both intraoperative and postoperative, over the course of the patient's hospital stay.|over course of hospital stay (averaging three days)||||||
656042|NCT01940523|Secondary|Drain Output|The amount of blood collected by a drain attached to the knee is measured 24 hours after surgery.|from end of surgery to 24 hours postoperatively|||ml||Standard Deviation|Mean
656043|NCT01940523|Primary|Total Blood Loss|The amount of blood lost during surgery is the primary outcome measure. Blood loss is determineusing an equation that calculates the patient's blood volume based on their height and weight, then multiplies the patient's blood volume by the change in their hematocrit after surgery compared to before surgery.|during surgery|||ml||Standard Deviation|Mean
656044|NCT01940510|Secondary|Total Molar Concentration of Alectinib and RO5468924 as Derived by Cmax|Cmax is the maximum observed molar plasma concentration for alectinib + RO5468924 (major pharmacologically active metabolite of alectinib). Cmax is presented in nanomoles per liter (nmol/L).|Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention period|PK analysis set||nmol/L||Standard Deviation|Mean
656045|NCT01940510|Secondary|Total Molar Concentration of Alectinib and RO5468924 as Derived by AUC(0-inf)|AUC(0-inf) is the area under the alectinib + RO5468924 (major pharmacologically active metabolite of alectinib) molar plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). AUC is a measure of the molar plasma concentration of the alectinib + RO5468924 over time. AUC(0-inf) is presented in nanomoles times (*) hour per liter (nmol*hour/L).|Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention period|PK analysis set||nmol*hour/L||Standard Deviation|Mean
656046|NCT01940510|Secondary|Apparent Volume of Distribution (Vz/F) of Alectinib|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction of drug absorbed.|Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention period|PK analysis set||liters||Standard Deviation|Mean
656047|NCT01940510|Secondary|Apparent Oral Clearance (CL/F) of Alectinib|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention period|PK analysis set||liters/hour||Standard Deviation|Mean
656048|NCT01940510|Secondary|Plasma Terminal Half-Life (t1/2) of Alectinib and RO5468924|Plasma terminal half-life is the time measured during drug elimination phase for the plasma drug concentration to decrease by one half. RO5468924 is the major pharmacologically active metabolite of alectinib.|Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention period|PK analysis set||hours||Standard Deviation|Mean
656049|NCT01940510|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Alectinib and RO5468924|The Tmax is the time from alectinib administration to reach Cmax for alectinib and RO5468924 (the major pharmacologically active metabolite of alectinib).|Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention period|PK analysis set||hours||Full Range|Median
656050|NCT01940510|Secondary|Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC[0-last]) of Alectinib and RO5468924|AUC(0-last) is the area under the alectinib and RO5468924 (major pharmacologically active metabolite of alectinib) plasma concentration time-curve from time zero to the last measured concentration. AUC is a measure of the plasma concentration of a drug over time. AUC(0-last) is presented in ng*hour/mL.|Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention period|PK analysis set||ng*hour/mL||Standard Deviation|Mean
656051|NCT01940510|Secondary|Molecular Weight Adjusted Metabolite to Parent (M/P) Ratio for Cmax|Cmax is the maximum observed plasma concentration of the alectinib and RO5468924 (major pharmacologically active metabolite of alectinib). The molecular weight adjusted M/P ratio (RO5468924/alectinib) for Cmax is presented.|Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention period|PK analysis set||ratio||Standard Deviation|Geometric Mean
656052|NCT01940510|Secondary|Molecular Weight Adjusted Metabolite to Parent (M/P) Ratio for AUC(0-inf)|AUC(0-inf) is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). AUC is a measure of the plasma concentration of the alectinib and RO5468924 (major pharmacologically active metabolite of alectinib) over time. The molecular weight adjusted M/P ratio (RO5468924/alectinib) for AUC(0-inf) is presented.|Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention period|PK analysis set||ratio||Standard Deviation|Geometric Mean
656054|NCT01940510|Secondary|AUC(0-inf) of RO5468924|AUC(0-inf) is the area under the RO5468924 (the major pharmacologically active metabolite of alectinib) plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). AUC is a measure of the plasma concentration of the drug over time. AUC(0-inf) is presented in ng*hour/mL.|Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention period|PK analysis set||ng*hour/mL||Standard Deviation|Mean
656055|NCT01940510|Primary|Maximum Observed Plasma Concentration (Cmax) of Alectinib|Cmax is the maximum observed alectinib plasma concentration, presented in nanogram per milliliter (ng/mL).|Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention period|PK analysis set||ng/mL||Standard Deviation|Mean
656056|NCT01940510|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to Extrapolated Infinite Time (AUC[0-inf]) of Alectinib|AUC(0-inf) is the area under the alectinib plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). AUC is a measure of the plasma concentration of a drug over time. AUC(0-inf) is presented in nanogram times (*) hour per milliliter (ng*hour/mL).|Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention period|The Pharmacokinetic (PK) analysis set included all participants who received both scheduled doses of alectinib (on Day 1 and Day 17), and provided adequate PK assessments.||ng*hour/mL||Standard Deviation|Mean
656057|NCT01940497|Secondary|Percentage of Health Care Professionals (HCPs) by Response to Health Care Professional Questionnaire (HCPQ)|Percentage of HCPs providing responses to various questions related to overall ease of study drug administration was reported in different categories, where categories indicate all possible responses to such questions.|After at least 4 participants completed 5 cycles of adjuvant treatment (1 cycle = 21 days; maximum up to 1 year)|HCPQ population included all investigators and study nurses who completed the questionnaire at each site when at least 4 participants from their site had received at least 5 cycles of adjuvant study treatment (52 and 50, respectively for Vial and SID groups).||percentage of health care professionals|||Number
656058|NCT01940497|Secondary|Percentage of Participants by Response to Patient Satisfaction Questionnaire (PSQ)|Participants were asked the following 5 questions: (1) “Following the first injection given by the physician/nurse and training on how to use the SID, I felt comfortable injecting the study drug by myself”; (2) “The SID was convenient and easy to use”; (3) “I am confident giving myself an injection in the thigh with the SID”; (4) “Taking all things into account, I find self-administration using the SID satisfactory”; (5) “If given the opportunity, I would choose to continue self-injecting the study drug using the SID at home”. Response to each question was recorded as either of the following options: “Unknown”, “Strongly Disagree”, “Disagree”, “Unsure”, “Agree”, “Strongly Agree”. Percentage of participants who provided responses to above questions was reported. Data for this outcome measure were analyzed and reported only for Trastuzumab (SID) arm.|After at least 14 cycles (1 cycle = 21 days; maximum up to 1 year)|PSQ population included all enrolled participants from trastuzumab (SID) group who were able to use SID and had completed a minimum of 14 administrations of trastuzumab subcutaneously using SID (at least 10 of which were self-administered). Here, ‘Number of Participants Analyzed’ = participants who were evaluable for this outcome measure.||percentage of participants|||Number
656059|NCT01940497|Secondary|Overall Survival (OS)|Overall survival was defined as the time from the first treatment to death from any cause. Kaplan-Meier estimates were used for analysis. Participants who did not die were censored on the date they were last known to be alive. Data for this outcome measure were analyzed and reported by adjuvant versus neoadjuvant chemotherapy groups within each treatment arm.|Day 1 up to death due to any cause (assessed up to cut off date 05 April 2016; up to approximately 2.5 years)|m-ITT population||months||95% Confidence Interval|Median
656060|NCT01940497|Secondary|Percentage of Participants Who Died|Data for this outcome measure were analyzed and reported by adjuvant versus neoadjuvant chemotherapy groups within each treatment arm.|Day 1 up to death due to any cause (assessed up to cut off date 05 April 2016; up to approximately 2.5 years)|m-ITT population||percentage of participants|||Number
656061|NCT01940497|Secondary|Disease-Free Survival (DFS) Using Mammography|DFS was defined as the time from the first treatment to local, regional or distant recurrence, contralateral breast cancer or death due to any cause (whichever occurred first). Kaplan-Meier estimates were used for analysis. Participants who were disease-free were censored at the data cut off date. Data for this outcome measure were analyzed and reported by adjuvant versus neoadjuvant chemotherapy groups within each treatment arm.|Day 1 up to local, regional or distant recurrence, contralateral breast cancer or death due to any cause (whichever occurred first) (assessed up to cut off date 05 April 2016; up to approximately 2.5 years)|m-ITT population. Here, ‘Number of Participants Analyzed’ = participants who were evaluable for this outcome measure.||months||95% Confidence Interval|Median
656062|NCT01940497|Secondary|Percentage of Participants With Event (Local, Regional or Distant Recurrence, Contralateral Breast Cancer or Death) Using Mammography|A participant was considered as disease free if the participant was free from local, regional or distant recurrence, contralateral breast cancer or death due to any cause (whichever occurred first). Percentage of participants with event at the cut off date were reported. Data for this outcome measure were analyzed and reported by adjuvant versus neoadjuvant chemotherapy groups within each treatment arm.|Day 1 up to local, regional or distant recurrence, contralateral breast cancer or death due to any cause (whichever occurred first) (assessed up to cut off date 05 April 2016; up to approximately 2.5 years)|m-ITT population. Here, ‘Number of Participants Analyzed’ = participants who were evaluable for this outcome measure.||percentage of participants|||Number
656063|NCT01940497|Secondary|Percentage of Participants With Pathological Complete Response (pCR) (Neoadjuvant Groups Only) Using Mammography|In the neoadjuvant setting, the activity of two sequential drug regimens, doxorubicin-containing chemotherapy followed by paclitaxel or docetaxel chemotherapy in combination with trastuzumab, was assessed as the percentage of participants with pCR in breast and nodes using mammography. pCR was defined as the absence of histological evidence of invasive breast cancer cells in the tissue specimen removed from the breast after preoperative treatment. Data for this outcome measure were analyzed and reported only for neoadjuvant groups within each treatment arm.|Day 1 up to 24 weeks|Modified intent-to-treat (m-ITT) population included all enrolled participants satisfying criteria for eligibility.||percentage of participants||95% Confidence Interval|Number
656067|NCT01940497|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were the AEs occurring from starting on the day of or after first administration of trastuzumab and within 28 days after last dose of trastuzumab. Data for this outcome measure were analyzed and reported by adjuvant versus neoadjuvant chemotherapy groups within each treatment arm.|Day 1 up to 28 days after last dose of trastuzumab (assessed up to cut off date 05 April 2016; up to approximately 1 year)|Safety population included all enrolled participants who received at least one dose of study medication.||percentage of participants|||Number
656068|NCT01940484|Secondary|Number of Participants Treated According to European Renal Best Practice Guideline (ERBPG) and National Kidney Function (NKF) Kidney Disease Outcomes Quality Initiative (NKF KDOQI) and Mircera Package Insert|Number of participants who received treatment as per the guidelines specified by ERBPG, NKF KDOQI, and Mircera package insert were to be reported.|Up to 6 months|Due to observational nature of the study, the data for this outcome measure could not be collected.|||||
656069|NCT01940484|Secondary|Number of Participants With Dose Adjustments of Methoxy Polyethylene Glycol-Epoetin Beta|Dose adjustment included dose increase or dose decrease with respect to previous visit’s dose.|Visit 2 (Month 1), Visit 3 (Month 2), Visit 4 (Month 3), Visit 5 (Month 4), Visit 6 (Month 5), Visit 7 (Month 6), Visit 8 (Month 7)|Included all enrolled participants who were evaluable for this outcome measure.||participants|||Number
656070|NCT01940484|Secondary|Mean Methoxy Polyethylene Glycol-Epoetin Beta Dose During the Study||Visit 2 (Month 1), Visit 3 (Month 2), Visit 4 (Month 3), Visit 5 (Month 4), Visit 6 (Month 5), Visit 7 (Month 6)|"Included all enrolled participants who were evaluable for this outcome measure and n represents number of participants evaluable at the specified time point."||mcg||Standard Deviation|Mean
656071|NCT01940484|Primary|Mean Hemoglobin Value at Visit 7 (Month 6)||Visit 7 (Month 6)|Included all enrolled participants who were evaluable for this outcome at the specified timepoint.||g/dL||Standard Deviation|Mean
656072|NCT01940484|Primary|Mean Hemoglobin Value at Visit 6 (Month 5)||Visit 6 (Month 5)|Included all enrolled participants who were evaluable for this outcome at the specified timepoint.||g/dL||Standard Deviation|Mean
656073|NCT01940484|Primary|Mean Hemoglobin Value at Visit 5 (Month 4)||Visit 5 (Month 4)|Included all enrolled participants who were evaluable for this outcome at the specified timepoint.||g/dL||Standard Deviation|Mean
656074|NCT01940484|Primary|Mean Hemoglobin Value at Visit 4 (Month 3)||Visit 4 (Month 3)|Included all enrolled participants who were evaluable for this outcome at the specified timepoint.||g/dL||Standard Deviation|Mean
656075|NCT01940484|Primary|Mean Hemoglobin Value at Visit 3 (Month 2)||Visit 3 (Month 2)|Included all enrolled participants who were evaluable for this outcome at the specified timepoint.||g/dL||Standard Deviation|Mean
656076|NCT01940484|Primary|Mean Hemoglobin Value at Visit 2 (Month 1)||Visit 2 (Month 1)|Included all enrolled participants who were evaluable for this outcome at the specified timepoint.||g/dL||Standard Deviation|Mean
656077|NCT01940484|Primary|Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 7 (Month 6)||Visit 7 (Month 6)|Included all enrolled participants who were evaluable for this outcome at the specified timepoint.||participants|||Number
656078|NCT01940484|Primary|Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 6 (Month 5)||Visit 6 (Month 5)|Included all enrolled participants who were evaluable for this outcome at the specified timepoint.||participants|||Number
656079|NCT01940484|Primary|Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 5 (Month 4)||Visit 5 (Month 4)|Included all enrolled participants who were evaluable for this outcome at the specified timepoint.||participants|||Number
656080|NCT01940484|Primary|Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 4 (Month 3)||Visit 4 (Month 3)|Included all enrolled participants who were evaluable for this outcome at the specified timepoint.||participants|||Number
656081|NCT01940484|Primary|Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 3 (Month 2)||Visit 3 (Month 2)|Included all enrolled participants who were evaluable for this outcome at the specified timepoint.||participants|||Number
656082|NCT01940484|Primary|Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 2 (Month 1)||Visit 2 (Month 1)|Included all enrolled participants who were evaluable for this outcome at the specified timepoint.||participants|||Number
656083|NCT01940471|Other Pre-specified|Percentage of Participants With Treatment-emergent Proteinuria by Urinalysis (Dipstick) Through Week 48|Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method.|Up to 48 weeks|Participants in the Safety Analysis Set with at least 1 postbaseline urine protein value were analyzed.||percentage of participants|||Number
656084|NCT01940471|Secondary|Change From Baseline at Week 48 in Serum Creatinine||Baseline; Week 48|Participants in the Safety Analysis Set with available data were analyzed. Participants were analyzed according to the treatment they actually received. Missing data were excluded from analysis.||mg/dL||Standard Deviation|Mean
656085|NCT01940471|Secondary|Percent Change From Baseline in Spine BMD at Week 48||Baseline; Week 48|Participants in the Spine DXA Analysis Set (participants who were randomized, received at least 1 dose of study drugs, and had nonmissing baseline spine BMD values) with available data were analyzed. Participants were analyzed according to the treatment they actually received. Missing data were excluded from analysis.||percentage change||Standard Deviation|Mean
656086|NCT01940471|Secondary|Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48||Baseline; Week 48|Participants in the Hip Dual-Energy X-ray Absorptiometry (DXA) Analysis Set (participants who were randomized, received at least 1 dose of study drugs, and had nonmissing baseline hip BMD values) with available data were analyzed. Participants were analyzed according to the treatment they actually received. Missing data were excluded from analysis.||percentage change||Standard Deviation|Mean
656087|NCT01940471|Secondary|Percentage of Participants With Hepatitis B e Antigen (HBeAg) Seroconversion to Antibody Against Hepatitis B e Antigen (Anti-HBe) at Week 48||Week 48|Serologically Evaluable Full Analysis Set: participants who were randomized, had received at least 1 dose of study drug, and were HBeAg positive and anti-HBe negative or had a value missing value at baseline. Participants were analyzed according to their randomized treatment group. All missing data were treated as no HBeAg seroconversion.||percentage of participants|||Number
656090|NCT01940341|Secondary|Change From Baseline in Serum Creatinine at Week 48||Baseline; Week 48|Participants in the Safety Analysis Set with available data were analyzed. Participants were analyzed according to the treatment they actually received. Missing data was excluded from analysis.||mg/dL||Standard Deviation|Mean
656091|NCT01940341|Secondary|Percent Change From Baseline in Spine BMD at Week 48||Baseline; Week 48|Participants in the Spine DXA Analysis Set (participants who were randomized, received at least 1 dose of study drugs, and had nonmissing baseline spine BMD values) with available data were analyzed. Participants were analyzed according to the treatment they actually received. Missing data was excluded from analysis.||percentage change||Standard Deviation|Mean
656092|NCT01940341|Secondary|Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48||Baseline; Week 48|Participants in the Hip Dual-Energy X-ray Absorptiometry (DXA) Analysis Set (participants who were randomized, received at least 1 dose of study drugs, and had nonmissing baseline hip BMD values) with available data were analyzed. Participants were analyzed according to the treatment they actually received. Missing data were excluded from analysis.||percentage change||Standard Deviation|Mean
656093|NCT01940341|Primary|Percentage of Participants With Hepatitis B Virus (HBV) DNA < 29 IU/mL|The primary efficacy endpoint was determined by the achievement of HBV DNA < 29 IU/mL at Week 48.|Week 48|Full Analysis set: participants who were randomized into the study and received at least 1 dose of study drugs. Participants were analyzed according to the treatment to which they were randomized.||Percentage of participants|||Number
656094|NCT01940146|Primary|Change in Total Nasal Symptom Score From Baseline to Day 14.|The 4-point (0=None, 1=Mild, 2=Moderate, and 3=Severe) intensity scale was summed across multiple symptoms (nasal congestion, rhinorrhea, nasal itching, and sneezing). Thus, the TNSS scores could range from 0 to 12, with higher scores indicative of greater severity.|Baseline to Day 14|||units on a scale||Standard Error|Least Squares Mean
656095|NCT01940120|Other Pre-specified|Incidence of Mitral Valve Replacement|Defined as how often patients receiving surgery required replacement of the mitral valve.|4 year|||participants|||Number
656096|NCT01940120|Other Pre-specified|Incidence of Mitral Valve Replacement|Defined as how often patients receiving surgery required replacement of the mitral valve.|3 year|||participants|||Number
656097|NCT01940120|Other Pre-specified|Incidence of Mitral Valve Replacement|Defined as how often patients receiving surgery required replacement of the mitral valve.|24 months|||participants|||Number
656098|NCT01940120|Other Pre-specified|Incidence of Mitral Valve Replacement|Defined as how often patients receiving surgery required replacement of the mitral valve.|12 months|||participants|||Number
656099|NCT01940120|Other Pre-specified|Transvalvular Mitral Valve Gradient|Defined as the mean pressure gradients across the mitral valve as measured by echocardiography.|4 year|Of 78 total population, 31 participants were included in analysis population because of 31 deaths within 3 years, 7 withdrawals, 1 missed visit and in 8 patients Mitral Valve Gradient evaluation was not done or un-evaluable.||mmHg||Standard Deviation|Mean
656100|NCT01940120|Other Pre-specified|Transvalvular Mitral Valve Gradient|Defined as the mean pressure gradients across the mitral valve as measured by echocardiography.|3 year|Of 78 total population, 36 participants were included in analysis population because of 31 deaths within 2 years, 7 withdrawals, 1 missed visit and in 3 patients Mitral Valve Gradient evaluation was not done or un-evaluable.||mmHg||Standard Deviation|Mean
656101|NCT01940120|Other Pre-specified|Transvalvular Mitral Valve Gradient|Defined as the mean pressure gradients across the mitral valve as measured by echocardiography.|24 months|Of 78 total population, 40 participants were included in analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and in 4 patients Mitral Valve Gradient evaluation was not done or un-evaluable.||mmHg||Standard Deviation|Mean
656102|NCT01940120|Other Pre-specified|Transvalvular Mitral Valve Gradient|Defined as the mean pressure gradients across the mitral valve as measured by echocardiography.|12 months|Of 78 total population, 53 participants were included in analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and in 3 patients Mitral Valve Gradient evaluation was not done or un-evaluable.||mmHg||Standard Deviation|Mean
656103|NCT01940120|Other Pre-specified|Transvalvular Mitral Valve Gradient|Defined as the mean pressure gradients across the mitral valve as measured by echocardiography.|30 days|Of 78 total population, 69 participants were included in the analysis population because of 6 deaths within 30 days and in 3 participants Mitral Valve Gradient was not done or un-evaluable.||mmHg||Standard Deviation|Mean
656104|NCT01940120|Other Pre-specified|Mitral Valve Area Index : By Planimetry|Mitral valve area as measured by core lab echocardiography by planimetry and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].|24 months|Of 78 total population, 19 participants were included in analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and in 25 patients Mitral Valve Area evaluation was not done or un-evaluable||cm^2/m^2||Standard Deviation|Mean
656105|NCT01940120|Other Pre-specified|Mitral Valve Area Index : By Planimetry|Mitral valve area as measured by core lab echocardiography by planimetry and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].|12 months|Of 78 total population, 45 participants were included in analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and in 11 patients Mitral Valve Area evaluation was not done or un-evaluable.||cm^2/m^2||Standard Deviation|Mean
656106|NCT01940120|Other Pre-specified|Mitral Valve Area Index: by Planimetry|Mitral valve area as measured by core lab echocardiography by planimetry and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].|30 days|Of 78 total population, 50 participants were included in analysis population because of 6 deaths and Mitral Valve Area Index by planimetry was not done in 22 patients.||cm^2/m^2||Standard Deviation|Mean
656107|NCT01940120|Other Pre-specified|Mitral Valve Area Index : By Pressure Half-time Formula|Mitral valve area as measured by core lab echocardiography using the pressure half-time formula and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].|24 months|Of 78 total population, 40 participants were included in the analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and in 4 patients Mitral Valve Area evaluation was not done or un-evaluable||cm^2/m^2||Standard Deviation|Mean
656129|NCT01940120|Other Pre-specified|Hospital Re-Admissions for Congestive Heart Failure (CHF)|Defined as the number of hospital admissions (i.e. events) for which the primary diagnosis for hospitalization is congestive heart failure, in the 12-months post-discharge following the MitraClip procedure.|12 months|3 patients who died prior to discharge not included.||events|||Number
656108|NCT01940120|Other Pre-specified|Mitral Valve Area Index : By Pressure Half-time Formula|Mitral valve area as measured by core lab echocardiography using the pressure half-time formula and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].|12 months|Of 78 total population, 53 participants were included in analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and in 3 patients Mitral Valve Area evaluation was not done or un-evaluable||cm^2/m^2||Standard Deviation|Mean
656109|NCT01940120|Other Pre-specified|Mitral Valve Area (MVA) Index: by Pressure-Half Time Formula|"Mitral valve area as measured by core lab echocardiography using the pressure half-time formula and indexed to Body surface area (BSA).
[MVA Index = MVA (cm^2)/BSA (m^2)]"|30 days|Of 78 total population, 65 participants were included in analysis population because of 6 deaths and Mitral Valve Area Index by pressure half-time was not done in 7 patients.||cm^2/m^2||Standard Deviation|Mean
656110|NCT01940120|Other Pre-specified|Mitral Valve Area: By Pressure Half-time|Mitral valve area as measured by core lab echocardiography.|24 months|Of 78 total population, 40 participants were included in analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and in 4 patients Mitral valve area evaluation was not done or un-evaluable.||cm^2||Standard Deviation|Mean
656111|NCT01940120|Other Pre-specified|Mitral Valve Area: By Pressure Half-time|Mitral valve area as measured by core lab echocardiography.|12 months|Of 78 total population, 53 participants were included in analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and in 3 patients Mitral valve area evaluation was not done or un-evaluable.||cm^2||Standard Deviation|Mean
656112|NCT01940120|Other Pre-specified|Mitral Valve Area: By Pressure Half-time|Mitral valve area as measured by core lab echocardiography.|30 days|Of 78 total population, 66 participants were included in analysis population because of 6 deaths and in 6 patients Mitral valve area evaluation was not done or un-evaluable.||cm^2||Standard Deviation|Mean
656113|NCT01940120|Other Pre-specified|Mitral Valve Area: By Planimetry|Mitral valve area as measured by core lab echocardiography.|4 year|Of 78 total population, 18 participants were included in analysis population because of 33 deaths within 4 years, 8 withdrawals, 3 missed visit and in 16 patients Mitral Valve Area evaluation was not done or un-evaluable.||cm^2||Standard Deviation|Mean
656114|NCT01940120|Other Pre-specified|Mitral Valve Area: By Planimetry|Mitral valve area as measured by core lab echocardiography.|3 year|Of 78 total population, 25 participants were included in analysis population because of 31 deaths within 3 years, 7 withdrawals, 1 missed visit and in 14 patients mitral valve area evaluation was not done or un-evaluable.||cm^2||Standard Deviation|Mean
656115|NCT01940120|Other Pre-specified|Mitral Valve Area: By Planimetry|Mitral valve area as measured by core lab echocardiography.|24 months|Of 78 total population, 19 participants were included in analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and in 25 patients Mitral valve area evaluation was not done or un-evaluable.||cm^2||Standard Deviation|Mean
656116|NCT01940120|Other Pre-specified|Mitral Valve Area: By Planimetry|Mitral valve area as measured by core lab echocardiography.|12 months|Of 78 total population, 45 participants were included in analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and in 11 patients Mitral valve area evaluation was not done or un-evaluable.||cm^2||Standard Deviation|Mean
656117|NCT01940120|Other Pre-specified|Mitral Valve Area: By Planimetry|Mitral valve area as measured by core lab echocardiography.|30 days|Of 78 total population, 50 participants were included in analysis population because of 6 deaths and Mitral Valve Area by planimetry was not done in 22 patients.||cm^2||Standard Deviation|Mean
656118|NCT01940120|Other Pre-specified|Cardiac Output|Cardiac output as measured by core lab echocardiography.|24 months|Of 78 total population, 40 participants were included in analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and in 4 patients Cardiac output evaluation was not done or un-evaluable.||l/min||Standard Deviation|Mean
656119|NCT01940120|Other Pre-specified|Cardiac Output|Cardiac output as measured by core lab echocardiography.|12 months|Of 78 total population, 53 participants were included in analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and in 3 patients Cardiac output evaluation was not done or un-evaluable.||l/min||Standard Deviation|Mean
656120|NCT01940120|Other Pre-specified|Cardiac Output|Cardiac output as measured by core lab echocardiography.|30 Days|Of 78 total population, 66 participants were included in analysis population because of 6 deaths within 30 days and in 6 patients Cardiac Output was not assessed or or un-evaluable.||l/min||Standard Deviation|Mean
656121|NCT01940120|Other Pre-specified|Cardiac Index|Cardiac index (cardiac output divided by body surface area) as measured by core lab echocardiography.|24 months|Of 78 total population, 40 participants were included in analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and in 4 patients cardiac index evaluation was not done or un-evaluable.||l/min/m2||Standard Deviation|Mean
656122|NCT01940120|Other Pre-specified|Cardiac Index|Cardiac index (cardiac output divided by body surface area) as measured by core lab echocardiography.|12 months|Of 78 total population, 53 participants were included in analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and in 3 patients Cardiac Index evaluation was not done or un-evaluable.||l/min/m2||Standard Deviation|Mean
656123|NCT01940120|Other Pre-specified|Cardiac Index|Cardiac index (cardiac output divided by body surface area) as measured by core lab echocardiography.|30 Days|Of 78 total population, 66 participants were included in the analysis population because of 6 deaths within 30 days and in 6 participants cardiac Index was un-evaluable or not done.||l/min/m2||Standard Deviation|Mean
656124|NCT01940120|Other Pre-specified|Mitral Valve Index|Mitral valve index (mitral valve area divided by body surface area) as measured by core lab echocardiography.|12 months|Of 78 total population, 45 participants were included in analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and in 11 patients Mitral valve index evaluation was not done or un-evaluable.||ratio||Standard Deviation|Mean
656125|NCT01940120|Other Pre-specified|Mitral Valve Index|Mitral valve index (mitral valve area divided by body surface area) as measured by core lab echocardiography.|30 days|Of 78 total population, 50 participants were included in the analysis population because of 6 deaths within 30 days and in 22 participants Mitral valve index was not done or un-evaluable.||ratio||Standard Deviation|Mean
656126|NCT01940120|Other Pre-specified|Incidence of New Coumadin Use|New onset use of Coumadin or warfarin to treat a potential thrombus on a defibrillator lead.|12 months|49 patients not on coumadin at baseline are included in the analysis.||participants|||Number
656130|NCT01940120|Other Pre-specified|Number of Days Re-hospitalized for CHF|Defined as the number of days hospitalized for CHF in the 12-months prior to the Clip implant procedure date compared to the number of days re-hospitalized for CHF in the 12-months after Clip implant.|12 months|12/75 hospitalized for CHF post-discharge, representing 22 separate hospitalization events with mean of 6.6+/-3.7 days.||days||Standard Deviation|Mean
656131|NCT01940120|Other Pre-specified|Incidence of Discharge to a Nursing Home or Skilled Nursing Facility|Discharge to a nursing home or skilled nursing facility following discharge from the hospital after definitive treatment.|30 Days|||participants|||Number
656132|NCT01940120|Other Pre-specified|Post-procedure Intensive Care Unit (ICU)/ Critical Care Unit (CCU) Time|Number of hours patients are in an intensive care unit or step down unit before discharge or moving to a standard care unit.|Length of ICU/CCU stay, assessed at 30 Days|||hours||Standard Deviation|Mean
656133|NCT01940120|Other Pre-specified|Post-procedure Length of Hospital Stay|Defined as the number of days from the end of the procedure until the patient is discharged from the hospital. This does not include time in a nursing or skilled care facility.|Length of Hospital Stay, assessed at 30 days|||days||Standard Deviation|Mean
656134|NCT01940120|Secondary|Composite Functional and Structural Measures - Clinical Measures of Benefit-New York Heart Association (NYHA) Class|"Class I: Patients with cardiac disease but without resulting limitations of physical activity.
Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.
Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|4 years|Of 78 total population, 31 participants were included in the analysis population because of 33 deaths within 3 years, 8 withdrawals, 3 missed visit and NYHA was not assessed in 3 patients.||participants|||Number
656135|NCT01940120|Secondary|MR Severity|"MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe.
MR severity was not consistently captured for patients in the Medical Management and Mitral Valve Surgery groups. The Medical Therapy & Mitral Valve Surgery comparator groups were followed & studied primarily from a health economic perspective. Availability of clinical outcomes at followup is limited & has not been validated. Clinical outcomes for the comparator groups will not be reported."|4 year|Of 78 total population, 31 participants were included in the analysis population because of 33 deaths within 3 years, 8 withdrawals, 3 missed visit and MR severity was not done or un-evaluable in 3 patients.||participants|||Number
656136|NCT01940120|Secondary|Mitral Valve Stenosis|Mitral stenosis associated with a total mitral valve orifice area less than 1.5 cm2.|4 year|||participants|||Number
656137|NCT01940120|Secondary|Freedom From All Cause Mortality|The endpoint is the actual observed procedural mortality of the intent to treat clip population versus this population's predicted procedural mortality, per the Society of Thoracic Surgeons (STS) risk calculator. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to predicted mitral valve surgery safety.|4 years|Analysis population includes 31 participants, which represents the number of patients at risk as per Kaplan-Meier analysis at 48 months.||participants|||Number
656138|NCT01940120|Secondary|Device Embolization or Single Leaflet Device Attachment|"Device embolization is defined as bilateral Clip detachment resulting in Clip embolization. Reasons for Clip embolization include leaflet tearing, Clip unlocking, Clip fracture or inadequate Clip placement (i.e., malposition). Not included are any fractures or other failures of the Clip that do not result in Clip detachment from both leaflets.
Single leaflet device attachment (SLDA) is defined as the loss of insertion of a single leaflet from the MitraClip device with ongoing insertion of the opposing leaflet. SLDAs are reported on ACCESS-EU adverse event log and MitraClip procedure electronic case report forms, and may also be reported by Abbott Vascular personnel per EU Vigilance requirements."|4 years|Patients implanted with a MitraClip device and alive were evaluated at 48 months.||participants|||Number
656139|NCT01940120|Secondary|MR Severity|"MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe.
MR severity was not consistently captured for patients in the Medical Management and Mitral Valve Surgery groups. The Medical Therapy & Mitral Valve Surgery comparator groups were followed & studied primarily from a health economic perspective. Availability of clinical outcomes at followup is limited & has not been validated. Clinical outcomes for the comparator groups will not be reported."|3 year|Of 78 total population, 37 participants were included in the analysis population because of 31 deaths within 3 years, 7 withdrawals, 1 missed visit and MR Severity was not done or un-evaluable in 2 patients.||participants|||Number
656140|NCT01940120|Secondary|Mitral Valve Stenosis|Mitral stenosis associated with a total mitral valve orifice area less than 1.5 cm2.|3 year|||participants|||Number
656141|NCT01940120|Secondary|Composite Functional and Structural Measures - Clinical Measures of Benefit-New York Heart Association (NYHA) Class|"Class I: Patients with cardiac disease but without resulting limitations of physical activity.
Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.
Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|3 years|Of 78 total population, 37 participants were included in analysis population because of 31 deaths within 3 years, 7 withdrawals, 1 missed visit and 2 patients without NYHA Class assessment.||participants|||Number
656144|NCT01940120|Secondary|Freedom From All Cause Mortality|The endpoint is the actual observed procedural mortality of the intent to treat clip population versus this population's predicted procedural mortality, per the Society of Thoracic Surgeons (STS) risk calculator. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to predicted mitral valve surgery safety.|3 years|Analysis population includes 39 participants, which represents the number of patients at risk as per Kaplan-Meier analysis at 36 months.||participants|||Number
656145|NCT01940120|Secondary|Device Embolization or Single Leaflet Device Attachment|"Device embolization is defined as bilateral Clip detachment resulting in Clip embolization. Reasons for Clip embolization include leaflet tearing, Clip unlocking, Clip fracture or inadequate Clip placement (i.e., malposition). Not included are any fractures or other failures of the Clip that do not result in Clip detachment from both leaflets.
Single leaflet device attachment (SLDA) is defined as the loss of insertion of a single leaflet from the MitraClip device with ongoing insertion of the opposing leaflet. SLDAs are reported on ACCESS-EU adverse event log and MitraClip procedure electronic case report forms, and may also be reported by Abbott Vascular personnel per EU Vigilance requirements."|3 years|Patients implanted with a MitraClip device, alive were evaluated at 36 months.||participants|||Number
656146|NCT01940120|Secondary|Device Embolization or Single Leaflet Device Attachment|"Device embolization is defined as bilateral Clip detachment resulting in Clip embolization. Reasons for Clip embolization include leaflet tearing, Clip unlocking, Clip fracture or inadequate Clip placement (i.e., malposition). Not included are any fractures or other failures of the Clip that do not result in Clip detachment from both leaflets.
Single leaflet device attachment (SLDA) is defined as the loss of insertion of a single leaflet from the MitraClip device with ongoing insertion of the opposing leaflet. SLDAs are reported on ACCESS-EU adverse event log and MitraClip procedure electronic case report forms, and may also be reported by Abbott Vascular personnel per EU Vigilance requirements."|24 months|Patients implanted with a MitraClip device, alive were evaluated at 24 months.||participants|||Number
656147|NCT01940120|Secondary|Mitral Valve Stenosis|Mitral stenosis associated with a total mitral valve orifice area less than 1.5 cm2.|24 months|||participants|||Number
656148|NCT01940120|Secondary|Freedom From Death and Mitral Valve Surgery||24 months|Analysis population includes 45 participants, which represents the number of patients at risk as per Kaplan-Meier analysis at 24 months.||participants|||Number
656149|NCT01940120|Secondary|Freedom From Mitral Valve Surgery||24 months|Analysis population includes 45 participants, which represents the number of patients at risk as per Kaplan-Meier analysis at 24 months.||participants|||Number
656150|NCT01940120|Secondary|Mitral Valve Repair Success|Freedom from mitral valve replacement surgery for Valve Dysfunction, death, re-operation, and MR > 2+.|24 months|Three Acute Procedural Success (APS) patients withdrew at or before 12 months, and had MR ≤ 2+ at all visits prior to withdrawal. Since there is no data on these patients post-12 months, these patients are not included in the endpoint of freedom from mitral valve replacement surgery for Valve Dysfunction, death and MR > 2+ at 24 months.||participants|||Number
656151|NCT01940120|Secondary|Regurgitant Fraction|Regurgitant fraction as measured by the core echocardiographic laboratory at follow-up.|24 months|Of 78 total population, 26 participants were included in analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and 18 patients were without Regurgitant fraction assessment.||percent||Standard Deviation|Mean
656152|NCT01940120|Secondary|Regurgitant Volume|Regurgitant volume as measured by the core echocardiographic laboratory at follow-up.|24 months|Of 78 total population, 26 participants were included in analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and 18 patients were without Regurgitant Volume assessment.||mL||Standard Deviation|Mean
656153|NCT01940120|Secondary|Clinical Durability|Proportion of patients who have an acute reduction in MR severity of at least one grade (as measured by the discharge echocardiogram) that have not required surgery for valve dysfunction and meet either of the following: 1) MR severity grade of 2+ or less or 2) a one grade reduction in MR severity compared to baseline accompanied by at least a one level reduction in NYHA.|24 months|Through 24 months, the clinical durability status of 3 patients is unknown and there were 35 patients with an acute reduction in MR severity from baseline of at least one grade (the one patient who underwent surgery between 12 months and 24 months is not included in the 35 patients).||participants|||Number
656154|NCT01940120|Secondary|Durability|Defined as the proportion of Acute Procedural Success patients with MR severity grade of 2+ or less that have not required surgery for valve dysfunction.|24 months|At 24 months, of the 56 patients who achieved acute procedural success, the status of 3 patients is unknown. Among the remaining 53 patients, 30 patients (56.6%) were alive and free from MR > 2+ at 24 months.||participants|||Number
656155|NCT01940120|Secondary|Freedom From All Cause Mortality|The endpoint is the actual observed procedural mortality of the intent to treat clip population versus this population's predicted procedural mortality, per the Society of Thoracic Surgeons (STS) risk calculator. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to predicted mitral valve surgery safety.|24 months|Analysis population 46 represents the number of patients at risk as per Kaplan-Meier analysis at 24 months.||participants|||Number
656156|NCT01940120|Secondary|MR Severity|"MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe.
MR severity was not consistently captured for patients in the Medical Management and Mitral Valve Surgery groups. The Medical Therapy & Mitral Valve Surgery comparator groups were followed & studied primarily from a health economic perspective. Availability of clinical outcomes at followup is limited & has not been validated. Clinical outcomes for the comparator groups will not be reported."|24 months|Of 78 total population, 42 participants were included in the analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and NYHA not assessed in 2 patients.||participants|||Number
656157|NCT01940120|Secondary|Mortality Rate|The endpoint is the actual observed procedural mortality of the intent to treat clip population versus this population's predicted procedural mortality, per the Society of Thoracic Surgeons (STS) risk calculator. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to predicted mitral valve surgery safety.|24 months|||participants|||Number
656158|NCT01940120|Secondary|Composite Functional and Structural Measures: Clinical Measures of Benefit-Left Ventricular (LV) Function: Left Ventricular Internal Dimension, Diastole (LVIDd), Left Ventricular Internal Dimension, Systole (LVIDs)|Left Ventricular Internal Dimension in diastole (LVIDd) and Left Ventricular Internal Dimension in systole (LVIDs) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).|24 months|Of 78 total population, 42 participants were included in the analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and LVIDd/LVIDs not done or un-evaluable in 2 patients.||cm||Standard Deviation|Mean
656159|NCT01940120|Secondary|Composite Functional and Structural Measures - Clinical Measures of Benefit-New York Heart Association (NYHA) Class|"Class I: Patients with cardiac disease but without resulting limitations of physical activity.
Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.
Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|24 months|Of 78 total population, 43 participants were included in the analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and 1 patient without NYHA Class assessment.||participants|||Number
656160|NCT01940120|Secondary|Composite Functional and Structural Measures: Clinical Measures of Benefit-Left Ventricular (LV) Function: Left Ventricular End-diastolic Volume (LVEDV), Left Ventricular End-systolic Volume (LVESV)|Left Ventricular End Diastolic Volume (LVEDV) and Left Ventricular End Systolic Volume (LVESV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).|24 months|Of 78 total population, 39 participants were included in the analysis population because of 26 deaths within 2 year, 7 withdrawals, 1 missed visit and LVEDV/LVESV was not done or un-evaluable in 5 patients.||mL||Standard Deviation|Mean
656161|NCT01940120|Secondary|Device Embolization or Single Leaflet Device Attachment|Device Embolization or Single Leaflet Device Attachment between day 0- 12 months|12 months|Three patients were excluded from the analysis as they did not receive a Device.||participants|||Number
656162|NCT01940120|Secondary|Freedom From Death and Mitral Valve Surgery||12 months|Analysis population includes 58 participants, which represents the number of patients at risk as per Kaplan-Meier freedom from death and mv surgery analysis at 12 months.||participants|||Number
656163|NCT01940120|Secondary|Composite Functional and Structural Measures - Freedom From Death and MR >2+||24 months|||percentage of participants||95% Confidence Interval|Number
656164|NCT01940120|Secondary|Composite Functional and Structural Measures - Freedom From Death|"Defined as all causes of death for the primary safety Major Adverse Event (MAE) Endpoint. Death is further divided into 2 categories:
A. Cardiac death is defined as death due to any of the following:
Acute myocardial infarction.
Cardiac perforation/pericardial tamponade.
Arrhythmia or conduction abnormality.
Stroke within 30 days of the procedure or stroke suspected of being related to the procedure.
Death due to any complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.
Any death for which a cardiac cause cannot be excluded.
B. Non-cardiac death is defined as a death not due to cardiac causes (as defined above)."|24 months|Analysis population includes 46 participants, which represents the number of patients at risk as per Kaplan-Meier freedom from mortality analysis at 24 months.||participants||95% Confidence Interval|Number
656165|NCT01940120|Secondary|Freedom From Mitral Valve Surgery||12 months|Analysis population includes 58 participants, which represents the number of patients at risk as per Kaplan-Meier freedom from Mitral valve (MV)surgery analysis at 12 months.||participants|||Number
656166|NCT01940120|Secondary|Freedom From All Cause Mortality|The endpoint is the actual observed procedural mortality of the intent to treat clip population versus this population's predicted procedural mortality, per the Society of Thoracic Surgeons (STS) risk calculator. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to predicted mitral valve surgery safety.|12 months|Analysis population includes 58 participants, which represents the number of patients at risk as per Kaplan-Meier freedom from mortality analysis at 12 months.||participants|||Number
656167|NCT01940120|Secondary|MR Severity|"MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe.
MR severity was not consistently captured for patients in the Medical Management and Mitral Valve Surgery groups. The Medical Therapy & Mitral Valve Surgery comparator groups were followed & studied primarily from a health economic perspective. Availability of clinical outcomes at followup is limited & has not been validated. Clinical outcomes for the comparator groups will not be reported."|12 months|Of 78 total population, 54 participants were included in the analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and MR Severity not done or un-evaluable in 2 patients.||participants|||Number
656168|NCT01940120|Secondary|Hemolysis|Defined as new onset of anemia associated with laboratory evidence of red cell destruction. Diagnosed when plasma free hemoglobin is greater than 40 mg/dL on two measures within 24 hours or on one measure if intervention is initiated based on other clinical symptoms.|12 months|||participants|||Number
656169|NCT01940120|Secondary|Mortality Rate|The endpoint is the actual observed procedural mortality of the intent to treat clip population versus this population's predicted procedural mortality, per the Society of Thoracic Surgeons (STS) risk calculator. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to predicted mitral valve surgery safety.|12 months|||participants|||Number
656170|NCT01940120|Secondary|Thrombosis|Evidence of formation of an independently moving thrombus on any part of the Clip or any commercially available implant used during surgery by echocardiography or fluoroscopy. If Clip is explanted or an autopsy is performed this diagnosis should be confirmed.|12 months|||participants|||Number
656188|NCT01940120|Secondary|Hemolysis|Defined as new onset of anemia associated with laboratory evidence of red cell destruction. Diagnosed when plasma free hemoglobin is greater than 40 mg/dL on two measures within 24 hours or on one measure if intervention is initiated based on other clinical symptoms|30 days|||participants|||Number
656171|NCT01940120|Secondary|MAE in Patients Over 75 Years of Age|Combined clinical endpoint of death, myocardial infarction, reoperation for failed surgical repair or replacement, nonelective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, GI complication requiring surgery, new onset of permanent atrial fibrillation, septicemia, and transfusion of 2 or more units of blood.|12 months|Analysis population includes 48 patients who were aged 75 years or older in the study.||participants|||Number
656172|NCT01940120|Secondary|Number of Participants Experiencing Major Vascular Complications|"Defined as the occurrence of any of the following resulting from the index procedure:
Hematoma at access site >6 cm;
Retroperitoneal hematoma;
Arterial-venous fistula;
Symptomatic peripheral ischemia/ nerve injury with clinical signs or symptoms lasting >24 hours;
Vascular surgical repair at catheter access sites;
Pulmonary embolism;
Ipsilateral deep vein thrombus; or
Access site-related infection requiring intravenous antibiotics and/or extended hospitalization."|12 months|||participants|||Number
656173|NCT01940120|Secondary|Major Bleeding Complications|Defined as procedure related bleeding that requires a transfusion of ≥2 units of blood and/or surgical intervention.|12 months|||participants|||Number
656174|NCT01940120|Secondary|Mitral Valve Stenosis|Mitral stenosis associated with a total mitral valve orifice area less than 1.5 cm2.|12 months|Total 78 participants, 72 participants were analyzed because 3 patients were not implanted with a device and 3 patients died prior to discharge.||participants|||Number
656175|NCT01940120|Secondary|Regurgitant Fraction|Regurgitant fraction as measured by the core echocardiographic laboratory at follow-up.|12 months|Of 78 total population, 44 participants were included in the analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and in 6 patients Regurgitant fraction evaluation was not done or not evaluable.||percent||Standard Deviation|Mean
656176|NCT01940120|Secondary|Regurgitant Volume|Regurgitant volume as measured by the core echocardiographic laboratory at follow-up.|12 months|Of 78 total population, 44 participants were included in the analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and in 6 patients Regurgitant volume evaluation was not done or not evaluable.||mL||Standard Deviation|Mean
656177|NCT01940120|Secondary|Atrial Septal Defect (ASD)|Occurrence of clinically significant ASD as a result of the procedure requiring intervention.|12 months|||participants|||Number
656178|NCT01940120|Secondary|Endocarditis|"Using Duke Criteria, endocarditis can be confirmed by:
Pathological criteria: Endocarditis is confirmed if microorganisms are identified by culture or histology in a vegetation, embolized vegetation, or an intracardiac abscess; or if pathological lesions are observed & histologically confirmed showing active endocarditis.
Clinical criteria: Endocarditis is confirmed by the presence of 2 major criteria, 1 major plus 3 minor criteria, or 5 minor criteria.
Major criteria include persistently +ve blood cultures with the presence of typical organisms for endocarditis; persistent bacteremia; evidence of endocardial involvement with positive echocardiogram with signs of oscillating vegetation, abscesses, valve perforation, new partial dehiscence of prosthetic valve or new valvular regurgitation.
Minor criteria include predisposing heart condition, fever, vascular phenomena, immunologic phenomena, & positive blood culture or echocardiogram not meeting major criteria."|12 months|||participants|||Number
656179|NCT01940120|Secondary|Number of Participants Experiencing Major Adverse Events|Combined clinical endpoint of death, myocardial infarction, reoperation for failed surgical repair or replacement, nonelective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, GI complication requiring surgery, new onset of permanent atrial fibrillation, septicemia, and transfusion of 2 or more units of blood.|12 months|||participants|||Number
656180|NCT01940120|Secondary|Non-cerebral Thromboembolism|Defined as any mural thrombus or thromboembolism in the vasculature (excluding central nervous system events) confirmed by standard clinical and laboratory testing and which requires intervention.|12 months|||participants|||Number
656181|NCT01940120|Secondary|Clinical Durability|Proportion of patients who have an acute reduction in MR severity of at least one grade (as measured by the discharge echocardiogram) that have not required surgery for valve dysfunction and meet either of the following: 1) MR severity grade of 2+ or less or 2) a one grade reduction in MR severity compared to baseline accompanied by at least a one level reduction in NYHA.|12 months|There were 62 patients with an acute reduction in MR severity of at least one grade, and of these, 43 patients met the criterion for clinical durability. The clinical durability rate is therefore 43/62, or 69.4%.||participants|||Number
656182|NCT01940120|Secondary|Mitral Valve Repair Success|Mitral Valve Repair Success defined as freedom from mitral valve replacement surgery for valve dysfunction, death, re-operation and MR > 2+ at 12 months.|12 months|||participants|||Number
656183|NCT01940120|Secondary|Durability|Defined as the proportion of Acute Procedural Success patients with MR severity grade of 2+ or less that have not required surgery for valve dysfunction.|12 months|Of 78 total population, 56 participants were included in the analysis population because of 18 deaths within 1 year, 3 withdrawals and 1 missed visit.||participants|||Number
656184|NCT01940120|Secondary|Dysrhythmias|Includes all new onset atrial fibrillation and heart block requiring placement of a permanent pacemaker.|12 months|||participants|||Number
656185|NCT01940120|Secondary|Mortality|The endpoint is the actual observed procedural mortality of the intent to treat clip population versus this population's predicted procedural mortality, per the Society of Thoracic Surgeons (STS) risk calculator. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to predicted mitral valve surgery safety.|12 months|||participants|||Number
656186|NCT01940120|Secondary|MR Severity|"MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe.
MR severity was not consistently captured for patients in the Medical Management and Mitral Valve Surgery groups. The Medical Therapy & Mitral Valve Surgery comparator groups were followed & studied primarily from a health economic perspective. Availability of clinical outcomes at followup is limited & has not been validated. Clinical outcomes for the comparator groups will not be reported."|At discharge, an average of 3.9 days following the MitraClip procedure|Analysis population includes 75 individuals as 3 patients died before discharge.||participants|||Number
656187|NCT01940120|Secondary|Procedural Freedom From In-hospital MAE|Percutaneous Clip procedure or surgery with no occurrence of in-hospital MAE.|30 Days|||participants|||Number
656189|NCT01940120|Secondary|Thrombosis|Evidence of formation of an independently moving thrombus on any part of the Clip or any commercially available implant used during surgery by echocardiography or fluoroscopy. If Clip is explanted or an autopsy is performed this diagnosis should be confirmed.|30 days|||participants|||Number
656190|NCT01940120|Secondary|Mitral Valve Stenosis|Mitral stenosis associated with a total mitral valve orifice area less than 1.5 cm2.|30 days|Of 78 total population, 72 were analyzed as 6 deaths within 30 days.||participants|||Number
656191|NCT01940120|Secondary|High Risk Procedural Success|Successful implantation of the Clip (s) with resulting MR severity of 2+ of less at discharge or a 1 grade MR reduction at discharge accompanied by a 1 level reduction in NYHA.|30 days|||participants|||Number
656192|NCT01940120|Secondary|Regurgitant Fraction|Regurgitant fraction as measured by the core echocardiographic laboratory at follow-up.|30 days|Of 78 total population, 58 participants were analysed as 6 participants died within 30 days and 14 missing data (not done or not evaluable).||percent||Standard Deviation|Mean
656193|NCT01940120|Secondary|Clip Implant Rate|Rate of successful delivery and deployment of Clip implants with echocardiographic evidence of leaflet approximation and retrieval of the investigational delivery catheter.|30 Days|||participants|||Number
656194|NCT01940120|Secondary|Major Bleeding Complications|Defined as procedure related bleeding that requires a transfusion of ≥2 units of blood and/or surgical intervention.|30 days|||participants|||Number
656195|NCT01940120|Secondary|Dysrhythmias|Includes all new onset atrial fibrillation and heart block requiring placement of a permanent pacemaker.|30 days|||participants|||Number
656196|NCT01940120|Secondary|Regurgitant Volume|Regurgitant volume as measured by the core echocardiographic laboratory at follow-up.|30 days|Of 78 total population, 58 participants were included in the analysis population because of 6 deaths within 30 days and 14 missing data (not done or not evaluable).||mL||Standard Deviation|Mean
656197|NCT01940120|Secondary|MAE in Patients Over 75 Years of Age|Combined clinical endpoint of death, myocardial infarction, reoperation for failed surgical repair or replacement, nonelective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, GI complication requiring surgery, new onset of permanent atrial fibrillation, septicemia, and transfusion of 2 or more units of blood.|30 days|Analysis population includes 48 patients who were aged 75 years or older in the study.||participants|||Number
656198|NCT01940120|Secondary|Atrial Septal Defect (ASD)|Occurrence of clinically significant ASD as a result of the procedure requiring intervention.|30 days|||participants|||Number
656199|NCT01940120|Secondary|Endocarditis|"Using Duke Criteria, endocarditis can be confirmed by:
Pathological criteria: Endocarditis is confirmed if microorganisms are identified by culture or histology in a vegetation, embolized vegetation, or an intracardiac abscess; or if pathological lesions are observed & histologically confirmed showing active endocarditis.
Clinical criteria: Endocarditis is confirmed by the presence of 2 major criteria, 1 major plus 3 minor criteria, or 5 minor criteria. Major criteria include persistently +ve blood cultures with the presence of typical organisms for endocarditis; persistent bacteremia; evidence of endocardial involvement with positive echocardiogram with signs of oscillating vegetation, abscesses, valve perforation, new partial dehiscence of prosthetic valve or new valvular regurgitation. Minor criteria include predisposing heart condition, fever, vascular phenomena, immunologic phenomena, & positive blood culture or echocardiogram not meeting major criteria."|30 days|||participants|||Number
656200|NCT01940120|Secondary|Non-cerebral Thromboembolism|Defined as any mural thrombus or thromboembolism in the vasculature (excluding central nervous system events) confirmed by standard clinical and laboratory testing and which requires intervention.|30 days|||participants|||Number
656201|NCT01940120|Secondary|Number of Participants Experiencing Major Vascular Complications|"Defined as the occurrence of any of the following resulting from the index procedure:
Hematoma at access site >6 cm;
Retroperitoneal hematoma;
Arterial-venous fistula;
Symptomatic peripheral ischemia/ nerve injury with clinical signs or symptoms lasting >24 hours;
Vascular surgical repair at catheter access sites;
Pulmonary embolism;
Ipsilateral deep vein thrombus; or
Access site-related infection requiring intravenous antibiotics and/or extended hospitalization."|30 days|||participants|||Number
656202|NCT01940120|Secondary|Number of Participants Experiencing Major Adverse Events (MAE)|Combined clinical endpoint of death, myocardial infarction, reoperation for failed surgical repair or replacement, nonelective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, GI complication requiring surgery, new onset of permanent atrial fibrillation, septicemia, and transfusion of 2 or more units of blood.|30 days|||participants|||Number
656203|NCT01940120|Primary|Composite Functional and Structural Measures: Clinical Measures of Benefit-Number of CHF Events Leading to Hospitalizations During Discharge Through 12 Months|Incidence of re-hospitalizations for CHF in the 12-months after the MitraClip implant procedure.|12 months|Three patients died before discharge and thus do not provide data on post-discharge hospitalizations.||re-hospitalization events|||Number
656204|NCT01940120|Primary|Composite Functional and Structural Measures: Clinical Measures of Benefit-Number of Patients With CHF Having Hospitalization During Discharge Through 12 Months|Number of patients with incidence of re-hospitalizations for CHF in the 12-months after the MitraClip implant procedure.|12 months|Three patients died before discharge and thus do not provide data on post-discharge hospitalizations.||participants|||Number
656205|NCT01940120|Primary|Composite Functional and Structural Measures: Clinical Measures of Benefit-Left Ventricular (LV) Function - Internal Dimension|Left Ventricular Internal Dimension in diastole (LVIDd) and Left Ventricular Internal Dimension in systole (LVIDs) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).|12 months|Of 78 total population, 54 participants were included in the analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and LIVDs/LVIDs evaluation was not done or un-evaluable in 2 patients.||cm||Standard Deviation|Mean
656206|NCT01940120|Primary|Composite Functional and Structural Measures: Clinical Measures of Benefit-Left Ventricular (LV) Function - End Diastolic/Systolic Volume|Left Ventricular End Diastolic Volume (LVEDV) and Left Ventricular End Systolic Volume (LVESV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).|12 months|Of 78 total population, 54 participants were included in the analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and LVEDV/LVESV was not done or un-evaluable in 2 patients.||mL||Standard Deviation|Mean
656207|NCT01940120|Primary|Composite Functional and Structural Measures - Clinical Measures of Benefit-Quality of Life (QOL) as Measured by Short Form (SF) 36|Standardized quality of life surveys allow physicians to evaluate the effectiveness of different treatment methods and the physical and psychological benefits a patient is likely to receive from a particular treatment.In the EVEREST II HRR,the patients were asked to complete the SF-36 QOL survey at baseline, 30 days and 12 months. The physical & mental function were assessed by the Physical Component Summary (PCS) score & Mental Component Summary (MCS) score. The PCS & MCS norms for 65-75 year olds are 44 and 52 respectively; and 31 & 46 for congestive heart failure (CHF) patients respectively. Each scale from the SF-36 is an algebraic sum of responses for all items in that scale.For ease of analysis each scale is then transformed to a 0-100 scale using a formula that converts the lowest & highest possible scores to 0 & 100 respectively.The scoring of the SF-36 indicates that 0% in a domain represents the poorest possible QoL & 100% indicates full QoL.|12 months|Of 78 total population, 51 participants were included in the analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and SF-36 not done in 5 patients.||score on a scale||Standard Deviation|Mean
656208|NCT01940120|Primary|Composite Functional and Structural Measures - Clinical Measures of Benefit-Quality of Life (QOL) as Measured by Short Form (SF) 36|Standardized quality of life surveys allow physicians to evaluate the effectiveness of different treatment methods and the physical and psychological benefits a patient is likely to receive from a particular treatment.In the EVEREST II HRR,the patients were asked to complete the SF-36 QOL survey at baseline, 30 days and 12 months. The physical & mental function were assessed by the Physical Component Summary (PCS) score & Mental Component Summary (MCS) score. The PCS & MCS norms for 65-75 year olds are 44 and 52 respectively; and 31 & 46 for congestive heart failure (CHF) patients respectively. Each scale from the SF-36 is an algebraic sum of responses for all items in that scale.For ease of analysis each scale is then transformed to a 0-100 scale using a formula that converts the lowest & highest possible scores to 0 & 100 respectively.The scoring of the SF-36 indicates that 0% in a domain represents the poorest possible QOL & 100% indicates full QOL.|30 days|Of 78 total population, 64 participants were included in the analysis population because of 3 deaths within 30 days, 4 withdrawals, 2 missed visit and SF-36 not done in 5 patients.||score on a scale||Standard Deviation|Mean
656209|NCT01940120|Primary|Composite Functional and Structural Measures - Clinical Measures of Benefit-New York Heart Association (NYHA) Class|"Class I: Patients with cardiac disease but without resulting limitations of physical activity.
Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.
Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|12 months|Of 78 total population, 54 participants were included in the analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and 2 patients without NYHA Class assessment.||participants|||Number
656210|NCT01940120|Primary|Composite Functional and Structural Measures - Freedom From Death and Mitral Regurgitation (MR) >2+|"The major effectiveness endpoint is an assessment of multiple functional and structural measures of benefit including: freedom from death at 12-months, freedom from death and MR >2+ at 12-months, and clinical measures of benefit at 12-months, including: New York Heart Association (NYHA) Class, QOL as measured by Short Form (SF) 36, re-hospitalizations for CHF and LV function.
The primary analysis cohort for the High Risk Registry, was the Intention to Treat population (all 78 subjects). The worst case analysis assumes that for any type of missing data, the Device group is assigned the failure value and the Control group is assigned the success value. In the worst case analysis for the HRR, there were only the Device group Intention to Treat patients, so only the preceding descriptions for the Device patient would apply."|12 months|||participants||95% Confidence Interval|Number
656211|NCT01940120|Primary|Composite Functional and Structural Measures - Freedom From Death|"Defined as all causes of death for the primary safety Major Adverse Event (MAE) Endpoint. Death is further divided into 2 categories:
A. Cardiac death is defined as death due to any of the following:
Acute myocardial infarction.
Cardiac perforation/pericardial tamponade.
Arrhythmia or conduction abnormality.
Stroke within 30 days of the procedure or stroke suspected of being related to the procedure.
Death due to any complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.
Any death for which a cardiac cause cannot be excluded.
B. Non-cardiac death is defined as a death not due to cardiac causes (as defined above)."|12 months|||participants||95% Confidence Interval|Number
656212|NCT01940120|Primary|Composite Functional and Structural Measures - Clinical Measures of Benefit-New York Heart Association (NYHA) Class|"The major effectiveness endpoint is an assessment of multiple functional and structural measures of benefit including New York Heart Association (NYHA) Class.
Class I: Patients with cardiac disease but without resulting limitations of physical activity.
Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.
Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|30 days|71 out of 78 patients (at baseline) were analyzed at 30 days. There were 6 deaths prior to 30 days. So, NYHA at 30 days is missing due to death in 6 patients, and missing due to other reasons in 1 patient.||participants|||Number
656213|NCT01940120|Primary|Mortality|The endpoint is the actual observed procedural mortality of the intent to treat clip population versus this population's predicted procedural mortality, per the Society of Thoracic Surgeons (STS) risk calculator. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to predicted mitral valve surgery safety.|30 days|||participants|||Number
656214|NCT01939938|Secondary|MRI of Upper Airway With Opposite PAP Mask|MRI will be used to obtain airway measurements and the position of soft tissue elements of the oropharyngeal airway will be evaluated while positive airway pressure in introduced through the opposite mask type.|Approximately 1 hour||||||
656216|NCT01939548|Secondary|Concentration of PF-02545920 and Its Metabolite, PF-01001252|Pharmacokinetic (PK) samples were collected at varying times relative to drug dosing whenever participants could be scheduled for study visits (sparse PK sampling). Thus, because of the variable time between the last dose and the collection of the PK samples, typical summary PK analyses were not planned or described in the study protocol and are not available. The study protocol analysis section specified that the sparse sampled PK data might be pooled with PK data from previous PF-02545920 clinical studies, however the study results did not support conducting those analyses.|Days 14, 28, 42, 56, 70, 84/Early Termination|Summary PK analyses were not planned or performed due to sparse PK sampling.|||||
656217|NCT01939548|Secondary|Overall Number of Participants With Positive Responses to Categories on the Columbia Suicide Severity Rating Scale (C-SSRS)|C-SSRS assessed whether participant experienced the following: completed suicide (Category 1), suicide attempt (Category 2; response of “Yes” on “actual attempt”), preparatory acts toward imminent suicidal behavior (Category 3; “Yes” on “preparatory acts or behavior”), suicidal ideation (Category 4; “Yes” on “wish to be dead”, “non-specific active suicidal thoughts”, “active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (Category 7; “Yes” on “Has subject engaged in non-suicidal self-injurious behavior”).|Baseline up to 7-10 days after last dose of study drug|All participants who had received at least 1 dose of study drug.||participants|||Number
656218|NCT01939548|Secondary|Absolute Values of Movement Disorder Burden Score - Dystonia (MDBS-D) Over Active Treatment Period|The MDBS-D quantified the dystonia burden during the active treatment period. For an individual participant, MDBS-D took into account all treatment-emergent dystonia events and was defined as a combination of the severity of the AE due to dystonia, AE duration, prescribed concomitant medication, and the total number of days the study treatment was received. Scores for the MDBS-D ranged from 0 (no dystonia events) to 4.5, with higher scores indicating greater dystonia burden.|Active treatment period (Weeks 1 to 12/Early Termination)|All participants who received at least 1 dose of study drug.||units on a scale||Standard Deviation|Mean
656219|NCT01939548|Secondary|Change From Baseline to Week 12 on the Extrapyramidal Symptom Rating Scale‑Abbreviated (ESRS‑A)|The ESRS-A is a 28-item instrument designed to facilitate standardized observations of parkinsonism, dystonia, dyskinesia, and akathisia. Ratings were determined through a combination of clinical interview and a motor examination. Scores were divided into individual domain scores and clinical global impression scores (CGI-S). Scores started from 0 (normal) to 6 (0 to 8 for CGI-S), with higher scores indicating greater severity.|Baseline, Week 12|All participants who received at least 1 dose of study drug. n=number of evaluable participants for each parameter at the specified time points.||units on a scale||Standard Deviation|Mean
656220|NCT01939548|Secondary|Change From Baseline in Prolactin at Weeks 6 and 12|Choleseterol, TG, HbA1c, LDL, HDL, insulin, and prolactin were a part of the laboratory tests done (metabolic tests).|Baseline; Weeks 6 and 12|All participants who had received at least 1 dose of study drug and who had available data for metabolic parameters. n=number of evaluable participants at the specified time points.||nanogram (ng)/milliliter||Standard Deviation|Mean
656221|NCT01939548|Secondary|Change From Baseline in Insulin at Weeks 6 and 12|Choleseterol, TG, HbA1c, LDL, HDL, insulin, and prolactin were a part of the laboratory tests done (metabolic tests).|Baseline; Weeks 6 and 12|All participants who had received at least 1 dose of study drug and who had available data for metabolic parameters. n=number of evaluable participants at the specified time points.||micro international unit/milliliter||Standard Deviation|Mean
656222|NCT01939548|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Weeks 6 and 12|Choleseterol, TG, HbA1c, LDL, HDL, insulin, and prolactin were a part of the laboratory tests done (metabolic tests).|Baseline; Weeks 6 and 12|All participants who had received at least 1 dose of study drug and who had available data for metabolic parameters. n=number of evaluable participants at the specified time points.||percent||Standard Deviation|Mean
656223|NCT01939548|Secondary|Change From Baseline in Cholesterol, Triglycerides (TG), Low-Density Lipoprotein (LDL), and High-Density Lipoprotein (HDL) at Weeks 6 and 12|Choleseterol, TG, glycosylated hemoglobin (HbA1c), LDL, HDL, insulin, and prolactin were a part of the laboratory tests done (metabolic tests).|Baseline; Weeks 6 and 12|All participants who had received at least 1 dose of study drug and who had available data for metabolic parameters. n=number of evaluable participants at the specified time points.||milligram (mg)/deciliter (dL)||Standard Deviation|Mean
656224|NCT01939548|Secondary|Number of Participants With Extrapyramidal Motor System (EPS) AEs|EPS AEs consisted of oromandibular dystonia, extrapyramidal disorder, akathisia, dyskinesia, and tremor.|Baseline up to 7-10 days after last dose of study drug (follow-up)|All participants who received at least 1 dose of study drug were included in the AE summarization/analysis.||participants|||Number
656225|NCT01939548|Secondary|Number of Participants With Laboratory Test Abnormalities|Number of participants with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters included hematology, liver function, renal function, lipids, electrolytes, hormones (prolactin), clinical chemistry, and urinalysis (dipstick and microscopy).|Screening up to Week 12/Early Termination and 7-10 days after last dose of study drug (hematology only)|All participants who had received at least 1 dose of study drug and who were evaluable for laboratory abnormalities.||participants|||Number
656226|NCT01939548|Secondary|Number of Participants With New/Intensified Physical Examination Findings From Baseline by Body Site|A complete physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems.|Baseline and Week 12 or Early Termination|All participants who received at least 1 dose of study drug and who were evaluable for physical examinations.||participants|||Number
656227|NCT01939548|Secondary|Number of Participants With Weight Change >=7%|The effects of PF-02545920 on body weight were evaluated. The number of participants with changes from baseline in body weight of >=7% were tabulated and summarized.|Screening up to Day 84|All participants who received at least 1 dose of study treatment.||participants|||Number
656319|NCT01938430|Secondary|Percentage of Participants With Posttransplant Virologic Response (pTVR) at Posttransplant Week 12|pTVR was defined as HCV RNA < LLOQ at Week 12 after transplant.|Posttransplant Week 12|Participants who had a liver transplant while on study were analyzed if their last observed HCV RNA measurement prior to transplant was < LLOQ. Participants who received a transplant from an HCV-infected donor were excluded from analysis.||percentage of participants|||Number
656228|NCT01939548|Secondary|Number of Participants With Electrocardiogram (ECG) Values Meeting Categorical Summarization Criteria|Criteria for ECG (12-lead) values meeting categorical summarization criteria were: the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization (PR interval >=300 milliseconds (msec) and increase from baseline >=25/50%; time from the beginning of the electrocardiogram Q wave to the end of the S wave corresponding to ventricular depolarization (QRS) interval >=140 msec and increase of >=50%; the beginning of the Q wave to the end of the T wave corresponding to electrical systole (QT) interval corrected using the Fridericia formula (QTcF) of 450 to <480 msec, 480 to <500 msec and >=500 msec, or an increase of 30 to <60 msec or >=60 msec.|Screening/Baseline up to Week 12 (or Early Termination)|All participants who received at least 1 dose of study drug were included in the safety analyses. n=number of evaluable participants for each specified ECG parameter.||participants|||Number
656229|NCT01939548|Secondary|Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria|Categorical summarization criteria in vital signs included: sitting, supine, and standing systolic blood pressure (SBP) of less than (<)90 millimeters of mercury (mm Hg) or change in sitting, supine and standing SBP of more than or equal to (>=)30 mm Hg; supine, sitting, and standing diastolic blood pressure (DBP) of <50 mm Hg or change in sitting, supine, and standing DBP of >=20 mm Hg; supine and sitting pulse rate of <40 or more than (>)120 beats per minute (bpm); and standing pulse rate of <40 or >140 bpm.|Screening up to 7-10 days after last dose of study drug (follow-up)|All participants who received at least 1 dose of study drug were included in the safety analyses. n=number of evaluable participants for each specified vital sign parameter.||participants|||Number
656230|NCT01939548|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations Due to Adverse Events (AEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs comprised both SAEs and non-SAEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse events (TEAEs) were defined as newly occurring AEs or those worsening after first dose.|Baseline up to 7-10 days after last dose of study drug (follow-up)|All participants who received at least 1 dose of study drug were included in the AE summarization/analysis.||participants|||Number
656231|NCT01939548|Secondary|Clinical Global Impression - Improvement (CGI-I) Total Score at Week 12|CGI-I: 7-point clinician-rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Week 12|Participants in the FAS who were evaluable for this outcome measure at Week 12.||units on a scale||Standard Deviation|Mean
656232|NCT01939548|Secondary|Change From Baseline to Week 12 in Clinical Global Impression of Severity (CGI-S)|CGI-S: 7-point clinician-rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Change: score at observation minus score at baseline.|Baseline, Week 12|All participants who received study treatment were included in the baseline evaluation. n=number of evaluable participants in the FAS at the specified time point.||units on a scale||Standard Deviation|Mean
656233|NCT01939548|Secondary|Change From Baseline to Week 12 in PANSS-Derived Marder Factor Scores|The subscales based on Marder factors are: negative symptoms, positive symptoms, disorganized thoughts factor, uncontrolled hostility/excitement factor, and anxiety/depression factor. The symptoms are rated on a 7-point scale, with a range of 7 to 49 for negative symptoms, 8 to 56 for positive symptoms, 7 to 49 for disorganized thoughts and 4 to 28 for uncontrolled hostility/excitement and anxiety/depression. Higher scores indicate higher severity of symptoms.|Baseline, Week 12|All participants who received study treatment were included in the baseline evaluation. At Week 12, the number of evaluable participants in the FAS were 40, 33, and 49.||units on a scale||Standard Deviation|Mean
656234|NCT01939548|Secondary|Change From Baseline to Week 12 in PANSS Positive, Negative, and General Subscales|The PANSS includes 3 scales and 30 items: 7 items that make up the Positive Scale (eg, delusions, conceptual disorganization, hallucinatory behavior); 7 items that make up the Negative Scale (eg, blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal); and 16 items that make up the General Psychopathology Scale (eg, somatic concern, anxiety, guilt feelings, mannerisms and posturing, motor retardation, uncooperativeness, disorientation, poor impulse control, preoccupation). Individual items are scored with values ranging from 1 to 7. Total Negative and Positive Subscale scores each range from 7 to 49; higher score indicates greater severity. Total General Psychopathology Subscale score range from 16 to 112; higher score indicates greater severity.|Baseline, Week 12|All participants who received study treatment were included in the baseline evaluation. At Week 12, the number of evaluable participants in the FAS were 40, 33, and 49.||units on a scale||Standard Deviation|Mean
656235|NCT01939548|Secondary|Change From Baseline to Week 12 in Personal and Social Performance Scale (PSP) Total Score|The Personal and Social Performance Scale (PSP) is a validated clinician-related scale that measured personal and social functioning in the domains of: socially useful activities (eg, work and study), personal and social relationships, self-care, disturbing and aggressive behaviors. Information from the participant and the informant were utilized in determining the rating. A PSP total score was determined from the 4 domains (score range 0-100). A score between 71 and 100 indicates a mild degree of difficulty; a score between 31 and 70 indicates a moderate degree of dysfunction, and a participant with a score of 30 or less has functioning so poor he or she requires intensive supervision.|Baseline, Week 12|All participants who received study treatment were included in the baseline evaluation. The number of evaluable participants at Week 12 were those in the FAS with available data at Week 12 (n=number of evaluable participants at the specified time point)||units on a scale||Standard Deviation|Mean
656248|NCT01939496|Secondary|Change From Baseline in Mean Daytime Diastolic Blood Pressure (DBP) to Day 2 and to Week 6|The diurnal rise (daytime) in blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings.|Baseline, Day 2 and Week 6|The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, “n” specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using LOCF method.||millimeter of mercury (mmHg)||Standard Deviation|Mean
656236|NCT01939548|Primary|Change From Baseline to Week 12 in PANSS Total Score|The PANSS assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS Total Score and ranges from 30 to 210; higher score indicates greater severity.|Baseline, Week 12|All participants in the Full Analysis Set (FAS, defined as all participants who received at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline measurement) who had available data for this outcome measure at Week 12.||units on a scale||Standard Deviation|Mean
656237|NCT01939548|Primary|Positive and Negative Syndrome Scale (PANSS) Total Score at Baseline|The Positive and Negative Syndrome Scale (PANSS) assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS Total Score and ranges from 30 to 210; higher score indicates greater severity.|Baseline|All participants who received study treatment.||units on a scale||Standard Deviation|Mean
656238|NCT01939496|Secondary|Change From Baseline in the Difference in Seated Heart Rate (HR) and Standing HR to Day 2, to Week 3, and to Week 6|The difference in seated heart rate and standing heart rate was evaluated.|Baseline, Day 2, Week 3 and 6|The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, “n” specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using LOCF method.||beats per minute||Standard Deviation|Mean
656239|NCT01939496|Secondary|Change From Baseline in the Difference in Seated Office Blood Pressure (BP) and Standing Office BP to Day 2, to Week 3, and to Week 6|The difference in seated office blood pressure and standing office blood pressure was evaluated.|Baseline, Day 2, Week 3 and 6|The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, “n” specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using LOCF method.||millimeter of mercury (mmHg)||Standard Deviation|Mean
656240|NCT01939496|Secondary|Change From Baseline in Standing Heart Rate (HR) to Day 2, to Week 3, and to Week 6|The standing heart rate was evaluated.|Baseline, Day 2, Week 3 and 6|The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, “n” specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using LOCF method.||beats per minute||Standard Deviation|Mean
656241|NCT01939496|Secondary|Change From Baseline in Seated Heart Rate (HR) to Day 2, to Week 3, and to Week 6|The seated heart rate was evaluated.|Baseline, Day 2, Week 3 and 6|The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, “n” specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using LOCF method.||beats per minute||Standard Deviation|Mean
656242|NCT01939496|Secondary|Change From Baseline in Standing Office Blood Pressure (BP) to Day 2, to Week 3, and to Week 6|The standing office blood pressure (BP) was evaluated for all participants based on the 24-hour BP recordings. SBP=Systolic Blood Pressure and DBP=Diastolic Blood Pressure.|Baseline, Day 2, Week 3 and 6|The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, “n” specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using LOCF method.||millimeter of mercury (mmHg)||Standard Deviation|Mean
656243|NCT01939496|Secondary|Change From Baseline in Seated Office Blood Pressure (BP) to Day 2, to Week 3, and to Week 6|The seated office blood pressure (BP) was evaluated for all participants based on the 24-hour BP recordings. SBP=Systolic Blood Pressure and DBP=Diastolic Blood Pressure.|Baseline, Day 2, Week 3 and 6|The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, “n” specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using LOCF method.||millimeter of mercury (mmHg)||Standard Deviation|Mean
656244|NCT01939496|Secondary|Change From Baseline in Body Weight to Week 6|Body weight was evaluated.|Baseline and Week 6|The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, “n” specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using LOCF method.||Kilogram (kg)||Standard Deviation|Mean
656245|NCT01939496|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) to Week 6|The fasting plasma glucose was evaluated.|Baseline and Week 6|The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, “n” specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using LOCF method.||millimoles per liter (mmol/L)||Standard Deviation|Mean
656246|NCT01939496|Secondary|Change From Baseline in Mean Nighttime Diastolic Blood Pressure (DBP) to Day 2 and to Week 6|The nocturnal fall (nighttime) in blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings.|Baseline, Day 2 and Week 6|The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, “n” specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using LOCF method.||millimeter of mercury (mmHg)||Standard Deviation|Mean
656247|NCT01939496|Secondary|Change From Baseline in Mean Nighttime Systolic Blood Pressure (SBP) to Day 2 and to Week 6|The nocturnal fall (nighttime) in blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings.|Baseline, Day 2 and Week 6|The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, “n” specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using LOCF method.||millimeter of mercury (mmHg)||Standard Deviation|Mean
656313|NCT01938430|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 12||Week 12|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants|||Number
656314|NCT01938430|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 8||Week 8|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants|||Number
656249|NCT01939496|Secondary|Change From Baseline in Mean Daytime Systolic Blood Pressure (SBP) to Day 2 and to Week 6|The diurnal rise (daytime) in blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings.|Baseline, Day 2 and Week 6|The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, “n” specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using LOCF method.||millimeter of mercury (mmHg)||Standard Deviation|Mean
656250|NCT01939496|Secondary|Change From Baseline in the Mean 24-Hour Diastolic Blood Pressure (DBP) to Day 2 and to Week 6|The blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings.|Baseline, Day 2 and Week 6|The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, “n” specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using LOCF method.||millimeter of mercury (mmHg)||Standard Deviation|Mean
656251|NCT01939496|Secondary|Change From Baseline in Mean 24-Hour Systolic Blood Pressure (SBP) to Day 2|The blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings.|Baseline and Day 2|The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, “n” specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using LOCF method.||millimeter of mercury (mmHg)||Standard Deviation|Mean
656252|NCT01939496|Primary|Change From Baseline in the Mean 24-Hour Systolic Blood Pressure (SBP) to Week 6|The blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings.|Baseline and Week 6|The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, “n” specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using last observation carried forward (LOCF) method.||millimeter of mercury (mmHg)||Standard Deviation|Mean
656253|NCT01939405|Secondary|Sedentary Time|Longer-term change in sedentary (non-active) time from baseline to 3-4 months post-intervention, objectively measured using accelerometers.|4 months from baseline|||minutes||Standard Deviation|Median
656254|NCT01939405|Secondary|Sedentary Time|Short-term change in sedentary (non-active) time from baseline to post-intervention, objectively measured using accelerometers|Immediately post-intervention|||minutes||Standard Deviation|Median
656255|NCT01939405|Secondary|Moderate-to-Vigorous Physical Activity (MVPA)|Longer term change in MVPA from baseline to 3-4 months post intervention|4 months from baseline|||minutes||Inter-Quartile Range|Median
656256|NCT01939405|Primary|Moderate to Vigorous Physical Activity (MVPA)|Short-term change in MVPA from baseline to post-intervention|Immediately post-intervention|||minutes||Inter-Quartile Range|Median
656257|NCT01939314|Secondary|Headache Free at 24 Hours|The percentage of patients that were headache free at 24 hours by follow-up phone conversation.|24 hours|||percentage of participants|||Number
656258|NCT01939314|Secondary|Categorical Pain Relief|"Categorical Pain Relief at 15 minutes. Participants were asked to categorize their pain relief at 15 minutes as No, Little, Some, A Lot or Complete. The table displays the number of participants who identified their pain relief in the categories provided."|15 minutes from dose|||participants|||Number
656259|NCT01939314|Primary|Number of Participants Who Reported a 50% or Greater Reduction in Pain at 15 Minutes as Measured on the 100mm Visual Analog Scale||15 minutes from dose|||percentage of participants|||Number
656260|NCT01939145|Other Pre-specified|Bacterial Culture Results|Compare the qualitative bacterial culture results between Prontosan NPWTi and normal saline NPWTi.|Patients will be followed during their hospital stay which is an average of approximately 2 weeks.||||||
656261|NCT01939145|Other Pre-specified|Wound Recidivism|Compare the percent of wounds that remained closed 30 days and up to one year after discharge between Prontosan NPWTi and normal saline NPWTi.|30 days post discharge from hospital||||||
656262|NCT01939145|Other Pre-specified|Time to Closure|Compare the percent of wounds closed and the time to closure during the hospital admission and up to one year after discharge between Prontosan NPWTi and normal saline NPWTi.|Patients will be followed during their hospital stay which is an average of approximately 2 weeks.||||||
656263|NCT01939145|Secondary|Hospital Admission Length of Stay|Compare the hospital admission length of stay between Prontosan NPWTi and normal saline NPWTi.|Patients will be followed during their hospital stay which is an average of approximately 2 weeks.|||days||Standard Deviation|Mean
656264|NCT01939145|Primary|Number of Operating Room Visits|Compare the number of operative room visits between Prontosan NPWTi and normal saline NPWTi.|Patients will be followed during their hospital stay which is an average of approximately 2 weeks.|||Operative Room Visits||Standard Deviation|Mean
656265|NCT01939002|Secondary|Antibody Data in the Overall Population: IFN β-1a Neutralizing Antibodies (Nabs) Testing|The number of participants who tested positive for IFN β-1a Nabs. Value was coded as 'positive' if observed value > 0 or coded as 'negative' if observed value < 0. This secondary endpoint was targeted to analyze the Overall Population only.|Baseline (Day 1), Week 12, Week 24, Week 36, Week 48 or early withdrawal (EW)|Safety population: participants who received at least 1 injection of study treatment and had an assessment; n=number of participants with an assessment at given timepoint.||participants|||Number
656266|NCT01939002|Secondary|Antibody Data in the Overall Population: IFN β-1a Anti-Pegylated (PEG) Antibody Testing|The number of participants who tested positive or negative for IFN β-1a anti-PEG antibodies. Value was coded as 'positive' if observed value > 0 or coded as 'negative' if observed value < 0. This secondary endpoint was targeted to analyze the Overall Population only.|Baseline (BL; Day 1), Week 12, Week 24, Week 36, Week 48 or early withdrawal (EW)|Safety population: participants who received at least 1 injection of study treatment and had an assessment; n=number of participants with an assessment at given timepoint.||participants|||Number
656267|NCT01939002|Secondary|Antibody Data in the Overall Population: IFN β-1a Antibody Screening|The number of participants who tested positive for IFN β-1a binding antibodies (BAbs). Value was coded as 'positive' if observed value > 0 or coded as 'negative' if observed value < 0. This secondary endpoint was targeted to analyze the Overall Population only.|Baseline (BL; Day 1), Week 12, Week 24, Week 36, Week 48 or early withdrawal (EW)|Safety population: participants who received at least 1 injection of study treatment and had an assessment; n=number of participants with an assessment at given timepoint.||participants|||Number
656268|NCT01939002|Secondary|Summary of Average Duration of FLS Within the Last 4 Weeks of the BIIB017 Treatment Period Compared With the Duration of FLS in the 4-Week Run-In Period|Average duration of FLS for the last 4 weeks (L4W) is defined as the mean duration of last 4 weeks. Duration of FLS for a treatment is defined as the sum of hours from the treatment to 48 hours with a FLS-S score > 0. The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. If a FLS is > 0 at an evaluation time, 6 hours were counted as the duration assuming the event started from previous evaluation time. 4WRI=4-week run-in.|Weeks -4 to -1 (Screening), Weeks 45-48 (last 4 weeks of study)|Efficacy population: randomized participants who received at least 1 dose of study treatment, had efficacy data in both the 4-week run-in period and the post-baseline treatment period, and had FLS; n=number of participants assessed at the given timepoint.||hours||Standard Deviation|Mean
656269|NCT01939002|Secondary|Summary of Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations Due to AEs|An AE was any untoward medical occurrence that did not necessarily have a causal relationship with this treatment. An SAE was any untoward medical occurrence that at any dose: resulted in death; in the view of the Investigator, placed the subject at immediate risk of death (a life-threatening event); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigator, could jeopardize the subject or could require intervention to prevent one of the other outcomes listed in the definition above. ISR=injection site reactions.|Day 1 to Week 52|Safety population: all participants who received at least 1 injection of study treatment.||participants|||Number
656270|NCT01939002|Secondary|Change From Baseline Visit (Day 1) to Week 48 in Walking Disability Status as Measured by Patient Determined Disease Steps (PDDS): Overall Population|Subjects rated their perceived walking disability on a scale of 0 to 8 using the PDDS, with higher scores indicating more severe disability. This secondary endpoint was targeted to analyze the Overall Population only.|Day 1 (Baseline, pre-dose), Week 12, Week 48, Early Termination|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.||units on a scale||Standard Deviation|Mean
656271|NCT01939002|Secondary|Mean Change From Screening at Each Visit in Absenteeism Questionnaire, Days Missed in 2 Weeks From MS Treatment: Overall Population|Categorical questions in the Absenteeism Questionnaire asked participants to report the number of usual work days per week, the number of days missed in 2 weeks from MS symptoms, and the number of days missed in 2 weeks from MS treatment. This secondary endpoint was targeted to analyze the Overall Population only. 4WRI=4-week run-in.|Week -4 (screening), Week 12, Week 24, Week 36, Week 48, Early Termination|Efficacy population: randomized participants who received at least 1 dose of study treatment, had efficacy data in both the 4-week run-in period and the post-baseline treatment period, and were employed; n=number of participants assessed at the given timepoint.||days||Standard Deviation|Mean
656272|NCT01939002|Secondary|Mean Change From Screening at Each Visit in Absenteeism Questionnaire, Days Missed in 2 Weeks From MS Symptoms: Overall Population|Categorical questions in the Absenteeism Questionnaire asked participants to report the number of usual work days per week, the number of days missed in 2 weeks from MS symptoms, and the number of days missed in 2 weeks from MS treatment. This secondary endpoint was targeted to analyze the Overall Population only. 4WRI=4-week run-in.|Week -4 (screening), Week 12, Week 24, Week 36, Week 48, Early Termination|Efficacy population: randomized participants who received at least 1 dose of study treatment, had efficacy data in both the 4-week run-in period and the post-baseline treatment period, and were employed; n=number of participants assessed at the given timepoint.||days||Standard Deviation|Mean
656273|NCT01939002|Secondary|Mean Change From Screening at Each Visit in Absenteeism Questionnaire, Usual Work Days Per Week: Overall Population|Categorical questions in the Absenteeism Questionnaire asked participants to report the number of usual work days per week, the number of days missed in 2 weeks from multiple sclerosis (MS) symptoms, and the number of days missed in 2 weeks from MS treatment. This secondary endpoint was targeted to analyze the Overall Population only. 4WRI=4-week run-in.|Week -4 (screening), Week 12, Week 24, Week 36, Week 48, Early Termination|Efficacy population: randomized participants who received at least 1 dose of study treatment, had efficacy data in both the 4-week run-in period and the post-baseline treatment period, and were employed; n=number of participants assessed at the given timepoint.||days||Standard Deviation|Mean
656274|NCT01939002|Secondary|Mean Change From 4-Week Run-In Period at Week 4 for TSQM, Global Satisfaction Scale Factor: Between FLS Management Arms|The TSQM assessed participants’ global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to Week 4 using transformed scores between 0 and 100 for global satisfaction (with higher scores indicating greater satisfaction) are presented. This secondary endpoint was targeted for Week 4 only. 4WRI=4-week run-in.|4-week run-in period, Week 4|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.||units on a scale||Standard Deviation|Mean
656275|NCT01939002|Secondary|Mean Change From 4-Week Run-In Period at Week 4 for TSQM, Convenience Scale Factor: Between FLS Management Arms|The TSQM assessed participants’ global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to Week 4 using transformed scores between 0 and 100 for convenience (with higher scores indicating greater satisfaction) are presented. This secondary endpoint was targeted for Week 4 only. 4WRI=4-week run-in.|4-week run-in period, Week 4|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.||units on a scale||Standard Deviation|Mean
656315|NCT01938430|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 6||Week 6|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants|||Number
656316|NCT01938430|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 4||Week 4|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants|||Number
656276|NCT01939002|Secondary|Mean Change From 4-Week Run-In Period at Week 4 for TSQM, Side Effects Scale Factor: Between FLS Management Arms|The TSQM assessed participants’ global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to Week 4 using transformed scores between 0 and 100 for side effects (with higher scores indicating greater satisfaction) are presented. This secondary endpoint was targeted for Week 4 only. 4WRI=4-week run-in.|4-week run-in period, Week 4|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.||units on a scale||Standard Deviation|Mean
656277|NCT01939002|Secondary|Mean Change From 4-Week Run-In Period at Week 4 for TSQM, Effectiveness Scale Factor: Between FLS Management Arms|The TSQM assessed participants’ global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to Week 4 using transformed scores between 0 and 100 for effectiveness (with higher scores indicating greater satisfaction) are presented. This secondary endpoint was targeted for Week 4 only. 4WRI=4-week run-in.|4-week run-in period, Week 4|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.||units on a scale||Standard Deviation|Mean
656278|NCT01939002|Secondary|Mean Change From 4-Week Run-In Period at Each Visit for TSQM, Global Satisfaction Scale Factor: Overall Population|The TSQM assessed participants’ global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to each visit using transformed scores between 0 and 100 for global satisfaction (with higher scores indicating greater satisfaction) are presented. 4WRI=4-week run-in.|4-week run-in period, Weeks 4, 12, 24, 36, 48 (or Early Termination)|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.||units on a scale||Standard Deviation|Mean
656279|NCT01939002|Secondary|Mean Change From 4-Week Run-In Period at Each Visit for TSQM, Convenience Scale Factor: Overall Population|The TSQM assessed participants’ global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to each visit using transformed scores between 0 and 100 for convenience (with higher scores indicating greater satisfaction) are presented. 4WRI=4-week run-in.|4-week run-in period, Weeks 4, 12, 24, 36, 48 (or Early Termination)|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.||units on a scale||Standard Deviation|Mean
656280|NCT01939002|Secondary|Mean Change From 4-Week Run-In Period at Each Visit for TSQM, Side-Effects Scale Factor: Overall Population|The TSQM assessed participants’ global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to each visit using transformed scores between 0 and 100 for side effects (with higher scores indicating greater satisfaction) are presented. 4WRI=4-week run-in.|4-week run-in period, Weeks 4, 12, 24, 36, 48 (or Early Termination)|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.||units on a scale||Standard Deviation|Mean
656281|NCT01939002|Secondary|Mean Change From 4-Week Run-In Period at Each Visit for Treatment Satisfaction Questionnaire for Medication (TSQM), Effectiveness Scale Factor: Overall Population|The TSQM assessed participants’ global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to each visit using transformed scores between 0 and 100 for effectiveness (with higher scores indicating greater satisfaction) are presented. 4WRI=4-week run-in.|4-week run-in period, Weeks 4, 12, 24, 36, 48 (or Early Termination)|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.||units on a scale||Standard Deviation|Mean
656282|NCT01939002|Secondary|Percentage of Participants Requiring Additional FLS Management Regimen to Relieve BIIB017-related FLS||during the first 8 weeks of treatment|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of subjects assessed at the given timepoint.||percentage of participants|||Number
656283|NCT01939002|Secondary|Summary of FLS-VAS During the 48 Weeks of Treatment Compared to 4-Week Run-In Period: Satisfaction With FLS Treatment|Participants reported their satisfaction with the effectiveness of their FLS management regimen on a 100-mm VAS between not satisfied (0) and very satisfied (100). 4WRI=4-week run-in period; 48W=48 weeks.|4-week run-in period, 48 weeks of treatment|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.||units on a scale||Standard Deviation|Mean
656284|NCT01939002|Secondary|Summary of FLS-VAS During the 48 Weeks of Treatment Compared to 4-Week Run-In Period: Effectiveness of FLS Treatment|Participants reported the effectiveness of their FLS management regimen on a 100-mm VAS between not effective (0) and very effective (100). 4WRI=4-week run-in period; 48W=48 weeks.|4-week run-in period, 48 weeks of treatment|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.||units on a scale||Standard Deviation|Mean
656285|NCT01939002|Secondary|Summary of FLS-VAS During the First 8 Weeks of Treatment Compared to 4-Week Run-In Period: Satisfaction With FLS Treatment|Participants reported their satisfaction with the effectiveness of their FLS management regimen on a 100-mm VAS between not satisfied (0) and very satisfied (100). 4WRI=4-week run-in period; F8W=first 8 weeks.|4-week run-in period, first 8 weeks of treatment|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.||units on a scale||Standard Deviation|Mean
656286|NCT01939002|Secondary|Summary of FLS-Visual Analogue Scale (VAS) During the First 8 Weeks of Treatment Compared to 4-Week Run-In Period: Effectiveness of FLS Treatment|Participants reported the effectiveness of their FLS management regimen on a 100-mm VAS between not effective (0) and very effective (100). 4WRI=4-week run-in period; F8W=first 8 weeks.|4-week run-in period, first 8 weeks of treatment|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.||units on a scale||Standard Deviation|Mean
656287|NCT01939002|Secondary|Summary of Average Duration of FLS in the 48 Weeks of Treatment|Duration of FLS for a treatment was defined as the sum of hours from the time of treatment to 48 hours with a FLS-S score > 0. The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. If a FLS is > 0 at an evaluation time, 6 hours were counted as the duration assuming the event started from previous evaluation time. Average duration of FLS for the first 8 weeks was defined as the mean duration from Weeks 0, 2, 4, 6, and 8. 4WRI=4-week run-in period; 48W=48 weeks.|4-week run-in period, 48 weeks of treatment|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of subjects assessed at the given timepoint.||hours||Full Range|Median
656288|NCT01939002|Secondary|Summary of Average Duration of FLS in the First 8 Weeks of Treatment|Duration of FLS for a treatment was defined as the sum of hours from the time of treatment to 48 hours with an FLS-S score > 0. The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. If an FLS is > 0 at an evaluation time, 6 hours were counted as the duration assuming the event started from previous evaluation time. Average duration of FLS for the first 8 weeks was defined as the mean duration from Weeks 0, 2, 4, 6, and 8. 4WRI=4-week run-in period; F8W=first 8 weeks.|4-week run-in period, first 8 weeks of treatment|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of subjects assessed at the given timepoint.||hours||Full Range|Median
656289|NCT01939002|Secondary|Summary of Severity of FLS (Per FLS-S) in the 48 Weeks of Treatment Compared to 4-Week Run-In Period Between Arms|The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. 4WRI=4-week run-in period; 48W=48 weeks.|4-week run-in period, 48 weeks of treatment|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period.||units on a scale||Standard Deviation|Mean
656290|NCT01939002|Secondary|Summary of Severity of FLS (Per FLS-S) in the First 8 Weeks Compared to 4-Week Run-In Period Between Arms|The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. 4WRI=4-week run-in period; F8W=first 8 weeks.|4-week run-in period, first 8 weeks of treatment|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period.||units on a scale||Standard Deviation|Mean
656291|NCT01939002|Secondary|Shift in Percentage of Participants With Any FLS From 4-Week Run-In Period to 48 Weeks|Any FLS is defined as an FLS-S total score > 0. The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. Pre-dose data not were used. Data up to 48-hours after dosing were used. Total score was imputed as the highest score after dose. 4WRI=4-week run-in period; 48W=48 weeks.|4-week run-in period, 48 weeks of treatment|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period.||percentage of participants|||Number
656292|NCT01939002|Secondary|Shift in Percentage of Participants With Any FLS From 4-Week Run-In Period to the First 8 Weeks|Any FLS is defined as an FLS-S total score > 0. The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. Pre-dose data not were used. Data up to 48-hours after dosing were used. Total score was imputed as the highest score after dose. 4WRI=4-week run-in period; F8W=first 8 weeks.|4-week run-in period, first 8 weeks of treatment|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period.||percentage of participants|||Number
656293|NCT01939002|Secondary|Percentage of Participants With Any FLS in the 4-Week Run-In Period, During the First 8 Weeks of Treatment, and During 48 Weeks of Treatment|Any FLS is defined as an FLS-S total score > 0. The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. 4WRI=4-week run-in; F8W=first 8 weeks; 48W=48 weeks.|4-week run-in period, first 8 weeks of treatment, 48 weeks of treatment|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period.||percentage of participants|||Number
656294|NCT01939002|Secondary|Percentage of Participants Experiencing New or Increased FLS During the First 8 Weeks: Between FLS Management Arms|The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. New or increased FLS is defined as an FLS overall score of 2 points or greater over Screening. Pre-dose data were not used; up to 48-hour data after dosing were used. Overall score was imputed as the average score after dose.|during the first 8 weeks of treatment|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period.||percentage of participants|||Number
656317|NCT01938430|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 2||Week 2|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants|||Number
656318|NCT01938430|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 1||Week 1|Full Analysis Set||percentage of participants|||Number
656295|NCT01939002|Primary|Percentage of Participants Experiencing New or Increased FLS During the First 8 Weeks: Overall Population|The total Flu-like Symptoms Score (FLS-S) is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. New or increased FLS is defined as an FLS overall score of 2 points or greater over Screening. Pre-dose data were not used; up to 48-hour data after dosing were used. Overall score was imputed as the average score after dose.|during the first 8 weeks of treatment|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period.||percentage of participants|||Number
656296|NCT01938989|Primary|Photostress Recovery Time|Photostress Recovery Time is the time necessary to recover function (e.g., contrast discrimination) following exposure to a bright glare source. The subject fixated on an image (black and white grating) and underwent photostress (glare) for 5 seconds. Only 1 eye (study eye) was assessed.|Day 1|This analysis population includes all participants with observation minus any major protocol deviations.||seconds||Standard Deviation|Mean
656297|NCT01938833|Secondary|Clinical Benefit Rate (CBR)|The 95% confidence intervals should be provided.|Up to 5 years||||||
656298|NCT01938833|Secondary|Overall Response Rate (ORR)|The 95% confidence intervals should be provided.|Up to 5 years|Effective August 18th 2016 no additional data was collected on enrolled patients. This change in data collection is due to both low accrual to the trial and a lack of funding for the Phase 2 portion, which was not opened to enrollment. The planned data analysis is not feasible due to the small number of patients who were accrued.|||||
656299|NCT01938833|Secondary|Incidence of Adverse Events, Graded According to NCI CTCAE Version 4.0|Summary tables of grade 2, 3, and 4 toxicities, adverse events (AE), and serious adverse events (SAE) will be generated at the conclusion of the study as well as at the conclusion of phase I study and after 15 patients have been collected on at the interim evaluation time point of the phase 2 part of the study.|Up to 30 days|Effective August 18th 2016 no additional data was collected on enrolled patients. This change in data collection is due to both low accrual to the trial and a lack of funding for the Phase 2 portion, which was not opened to enrollment. The planned data analysis is not feasible due to the small number of patients who were accrued.|||||
656300|NCT01938833|Primary|Progression-Free Survival (PFS)||The duration of time from start of treatment to time of progression or death, whichever occurs first, assessed up to 5 years|Effective August 18th 2016 no additional data was collected on enrolled patients. This change in data collection is due to both low accrual to the trial and a lack of funding for the Phase 2 portion, which was not opened to enrollment. The planned data analysis is not feasible due to the small number of patients who were accrued.|||||
656301|NCT01938833|Primary|Maximum-Tolerated Dose of Romidepsin (Phase I)|Determined according to incidence of dose-limiting toxicity, graded using the National Cancer Institute (NCI) CTCAE version 4.0|28 days|Effective August 18th 2016 no additional data was collected on enrolled patients. This change in data collection is due to both low accrual to the trial and a lack of funding for the Phase 2 portion, which was not opened to enrollment. The planned data analysis is not feasible due to the small number of patients who were accrued.|||||
656302|NCT01938430|Secondary|Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in CPT Score|CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15 (maximum score for entry into the study was 12); higher scores/increased scores indicate greater severity of disease. Groups are arranged by cohort, then by duration of treatment, then by CPT class at baseline.|Baseline to Posttreatment Week 4|Full Analysis Set. Cirrhotic participants were analyzed if they had measurements at both baseline and Posttreatment Week 4. Only groups with cirrhotic participants are presented.||percentage of participants|||Number
656303|NCT01938430|Secondary|Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in MELD Score|Model for End-Stage Liver Disease (MELD) scores are used to assess prognosis and suitability for liver transplantation. Scores can range from 6 to 40; higher scores/increased scores indicate greater severity of disease.|Baseline to Posttreatment Week 4|Full Analysis Set. Participants with cirrhosis were analyzed if they had measurements at both baseline and Posttreatment Week 4. Only groups with cirrhotic participants are presented.||percentage of participants|||Number
656304|NCT01938430|Secondary|HCV RNA and Change From Baseline at Week 12||Baseline; Week 12|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
656305|NCT01938430|Secondary|HCV RNA and Change From Baseline at Week 8||Baseline; Week 8|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
656306|NCT01938430|Secondary|HCV RNA and Change From Baseline at Week 6||Baseline; Week 6|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
656307|NCT01938430|Secondary|HCV RNA and Change From Baseline at Week 4||Baseline; Week 4|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
656308|NCT01938430|Secondary|HCV RNA and Change From Baseline at Week 2||Baseline; Week 2|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
656309|NCT01938430|Secondary|HCV RNA and Change From Baseline at Week 1||Baseline; Week 1|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
656310|NCT01938430|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 24||Week 24|Participants in the Full Analysis Set who were randomized to a 24-week treatment group and had available data were analyzed. 12-week treatment groups (did not collect data past Week 12) are not presented in this table.||percentage of participants|||Number
656311|NCT01938430|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 20||Week 20|Participants in the Full Analysis Set who were randomized to a 24-week treatment group and had available data were analyzed. 12-week treatment groups (did not collect data past Week 12) are not presented in this table.||percentage of participants|||Number
656312|NCT01938430|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 16||Week 16|Participants in the Full Analysis Set who were randomized to a 24-week treatment group and had available data were analyzed. 12-week treatment groups (did not collect data past Week 12) are not presented in this table.||percentage of participants|||Number
656320|NCT01938430|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as:
On-treatment virologic failure:
Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ on 2 consecutive measurements while on treatment), or
Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment)
Virologic relapse:
Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 24|Full Analysis Set. Participants were excluded from the analysis if they received a liver transplant while on study (with HCV RNA <LLOQ at transplant) prior to lower bound of Posttreatment Week 12 visit window.||percentage of participants|||Number
656321|NCT01938430|Secondary|Percentage of Participants With SVR 24 Weeks After Discontinuation of Therapy (SVR24)|SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.|Posttreatment Week 24|Full Analysis Set. Participants in Cohort A who received a liver transplant prior to the lower bound of the Posttreatment Week 24 visit were not included in the analysis.||percentage of participants|||Number
656322|NCT01938430|Secondary|Percentage of Participants With SVR 8 Weeks After Discontinuation of Therapy (SVR8)|SVR8 was defined as HCV RNA < LLOQ at 8 weeks after stopping study treatment.|Posttreatment Week 8|Full Analysis Set. Participants in Cohort A who received a liver transplant prior to the lower bound of the Posttreatment Week 8 visit were not included in the analysis.||percentage of participants|||Number
656323|NCT01938430|Secondary|Percentage of Participants With SVR 4 Weeks After Discontinuation of Therapy (SVR4)|SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.|Posttreatment Week 4|Full Analysis Set. Participants in Cohort A who received a liver transplant prior to the lower bound of the Posttreatment Week 4 visit were not included in the analysis.||percentage of participants|||Number
656324|NCT01938430|Secondary|Percentage of Participants With SVR 2 Weeks After Discontinuation of Therapy (SVR2)|SVR2 was defined as HCV RNA < LLOQ at 2 weeks after stopping study treatment.|Posttreatment Week 2|Full Analysis Set. Participants in Cohort A who received a liver transplant prior to the lower bound of the Posttreatment Week 2 visit were not included in the analysis.||percentage of participants|||Number
656325|NCT01938430|Primary|Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event||Up to 24 weeks|Safety Analysis Set: participants who were randomized and received at least one dose of study drug||percentage of participants|||Number
656326|NCT01938430|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants who were randomized and received at least one dose of study drug. Participants in Cohort A who received a liver transplant prior to the lower bound of the Posttreatment Week 12 visit were not included in the analysis.||percentage of participants|||Number
656327|NCT01938391|Primary|Percent (%) Area Stenosis|Percentage (%) of area stenosis as assessed by the intravascular ultrasound (IVUS) Core Lab. Percentage of area stenosis was calculated as 1 - (minimum lumen area / reference lumen area).|Index Procedure (pre-procedure, post-OAS treatment and post-balloon treatment)|At the time of analysis 24 of 29 lesions in 25 participants could be assess by the IVUS Core Lab.||percent area stenosis|lesions|Inter-Quartile Range|Median
656328|NCT01938391|Primary|Stent Usage at the Time of the Index Procedure|Number of lesions with a stent placed during the index procedure.|Index Procedure|Number of stents placed is based on number of lesions treated in the total subject population of 25. The total number of lesions treated were 29 and of those 29 lesions, 17 had a stent placed.||Lesions|Lesions||Number
656329|NCT01938391|Primary|Rutherford Classification (RC)|"Rutherford Classification (RC) is a commonly used clinical grading system for describing peripheral arterial disease (PAD) on a scale of 0 to 6. RC 6 is the most severe form of PAD. The RC is assessed for each participant at baseline and at each follow-up visit.
RC classification is as follows:
RC 0: Asymptomatic, no hemodynamically significant occlusive disease RC 1-3: Mild to Severe Claudication, limitation with ordinary physical activities, patient is comfortable at rest RC 4-5: Ischemic rest pain, minor tissue loss, non healing ulcer, focal gangrene RC 6: Major tissue loss, functional foot no longer salvageable"|Baseline, 2 weeks, 6 month and 12 month|At the time of analysis for the 6 month visit 1 participant missed their follow up visit. At the time of analysis for the 12 month visit, 22 participants completed the 12 month follow up visit.||Participants|||Count of Participants
656330|NCT01938391|Primary|Ankle-Brachial Index (ABI) Measurments|The ankle-brachial index (ABI) is the ratio of the systolic blood pressure (SBP) measured at the ankle to that measured at the brachial (upper arm) artery. Normal range of ABI is 0.9 - 1.2. Values less than 0.9 suggests presence of peripheral artery disease (PAD). Values greater than 1.2 suggests of non-compressible vessel.|Baseline, 2 weeks, 6 months and 12 months|At the time of this analysis 3 of the subjects did not have their ABI measured at baseline, 1 participant did not have their ABI measured at 2 weeks, 1 participant did not have their ABI measured at 6 months and 1 participant did not have their ABI measured at 12 months.||ratio||Standard Deviation|Mean
656331|NCT01938391|Primary|Rate of Procedural Angiographic Complications|Percent of study participants with an Investigator reported procedural angiographic complication (flow limiting dissection, perforation, slow flow/no flow, distal embolization and recoil).|Index Procedure|||Participants|||Count of Participants
656332|NCT01938391|Primary|Mean Maximum Balloon Inflation Pressure|Mean maximum balloon inflation pressure of balloons used pre-stent placement.|Index Procedure|||atm|balloons|Standard Deviation|Mean
656333|NCT01938391|Primary|Rate of Clinically Driven Target Lesion Revascularization (TLR)|A Kaplan-Meier analysis was performed to determine the percent probability that a study participant had a TLR at 6 months and at 12 months.|6 months and 12 months|||% probablity of clinically driven TLR||95% Confidence Interval|Number
656334|NCT01938170|Secondary|Number of Subjects That Reported Ability to Successfully Administer FluMist Vaccine at Home|This study will also assess the feasibility of having parents/caregivers administer Flumist vaccine outside a traditional medical environment and without the direct participation of medical personnel. We will ask parents by telephone survey at both 24-48 hours and at 9-12 days after study visit and enrollment about any difficulties in giving FluMist at home, about maintaining temperature and conditions proper for vaccine storage until administration. We will also ask about ease of vaccine disposal and about child preferences for receiving vaccine at home compared to at a dedicated medical visit.|0-12 days|||participants|||Number
656335|NCT01938170|Primary|Number of Subjects That Reported Successful Home Vaccination With no Adverse Events|We will assess the tolerability of giving the FluMist nasal vaccine at home by parents/caregivers to their children by performing telephone survey follow up. We will ask parents at both 24-48 hours and at 9-12 days after study visit and enrollment about any difficulties in giving FluMist at home and any adverse events encountered when giving FluMist at home.|0-12 days|||participants|||Number
656336|NCT01938079|Primary|Cumulative Fentanyl Equivalents From ECMO Initiation to Decision to Achieve Wakefulness|Culmulative fentanyl equivalents meaning the combination of sedative drug regimen - measured in mg - from ECMO initiation to decision to achieve wakefulness.|Up to 14 days|||mg||Inter-Quartile Range|Median
656337|NCT01938066|Secondary|Amount of Pain Medication Used (Morphine)|will measure the amount of pain medication used (morphine)|5 days|||mg||Standard Deviation|Mean
656338|NCT01938066|Primary|Wound Infection|At the end of 5 days all subjects will get a Culture and Sensitivity to see if they have an infection or what type of infection they have in the wound|At the end of 5 days|||participants|||Number
656339|NCT01938040|Secondary|Geriatric Depression Scale|15 questions. Score 1 point for each answer selected which indicates depression. Score of 0-5 is normal. A score >5 suggests depression.|Preoperatively, post operative day 1 and post op day3|||units on a scale||Standard Deviation|Mean
656340|NCT01938040|Secondary|Cognitive Recovery.|Digits span forward subject is asked to repeat a series of numbers with increasing number of digits forward. Digit span backward subject is asked to repeat a series of numbers backward with increasing number of digits. Correct response is worth 1 point. Maximum of 14 points for each sub score with a total of 28 points for total score|preoperatively- 2 hours in PACU, Post op day #1, post op day#3|||units on a scale||Standard Deviation|Mean
656341|NCT01938040|Other Pre-specified|Cytokine Concentrations|IFN y, IL-1B IL-2 were below the limit of detection and no assessments could be made. The lower limit for all cytokine detection was 3.2pg/mL|preoperative-intraoperative-postopoperative||||||
656342|NCT01938040|Secondary|Immune Response:Serum Concentration of IL-10,|.drawn in PACU 2 hours following arrival and compared to preoperative and intraoperative values|2 hours post arrival in PACU|||pg/mL||Full Range|Mean
656343|NCT01938040|Secondary|Modified Fatigue Severity Scale|This questionnaire contains 9 statements that rate severity of fatigue symptoms. Score 1 indicates strong disagreement with the statement and 7= strong agreement. i.e (I am easily fatigued).Total lowest possible score indicating no fatigue is 9. Total highest possible score is 63 which correlates to severe fatigue, interfering with all activities of daily living.|preoperative-postoperative day 1 and day 3|||scores on a scale||Standard Deviation|Mean
656344|NCT01938040|Secondary|Quality of Recovery-40|Quality of Recovery-40 has been used to assess postoperative recovery from anesthesia where higher score correlate with improved recovery and well being. The survey has 5 domains: comfort scale ranges 1-60 with higher value indicating greater comfort, emotions scale ranges 1-45 with higher value indicating best emotional state, physical independence scale ranges 1-25 with higher value indicating best independence, patient support scale ranges 1-35 with a higher score indicating greater support and pain scale 1-35 with higher number indicating greater relief from pain. Scoring is done for PART A on a scale of 1-5 (1=very poor=none of the time, worst score, 5=excellent=all of the time, best possible score).PART B on a scale of 1-5 (1=very poor or all the time worse score), 5=excellent or none of the time, best score) Perfect score=200.|preoperatively and -postoperative days 1 and 3|||units on a scale||Standard Deviation|Mean
656345|NCT01938040|Secondary|Immune Response IL-6||2 hours postoperatively in PACU|||pg/mL||Full Range|Mean
656346|NCT01938040|Post-Hoc|IL-6||preoperatively-intraoperatively-postoperatively|||pg/mL||Full Range|Mean
656347|NCT01938040|Post-Hoc|Immune Response: TNF Alpha||preoperatively-intraoperatively-postoperatively|||pg/mL||Full Range|Mean
656348|NCT01938040|Post-Hoc|Sympathetic Response: Epinephrine and Norepinephrine Plasma Concentrations||intraoperatively|||pg/mL||Standard Deviation|Mean
656349|NCT01938040|Primary|Stress Response Inflammation Markers :Cortisol and C Reactive Protein (CRP)|Serum concentration of cortisol, CRP, drawn in Post Anesthesia Care unit at 2 hours following surgery were compared with those same levels drawn preoperatively and intraoperatively.|2 hours following end of surgery|||pg/mL||Standard Deviation|Mean
656350|NCT01937975|Primary|Apparent Volume of Distribution After Extravascular Administration (Vz/F) of Elbasvir|Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 10|Up to 24 hours postdose|The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model. End Stage Renal Disease for Non-HD Day 9 was not reported since only 24-hour collections were made on that day.||Liters||95% Confidence Interval|Geometric Mean
656351|NCT01937975|Primary|Apparent Clearance After Extravascular Administration (CL/F) of Elbasvir|Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants)|Up to 24 hours postdose|The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model.||Liters/hr||95% Confidence Interval|Geometric Mean
656352|NCT01937975|Primary|Apparent Terminal Half-life (T1/2) of Elbasvir|Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10|Up to 120 hours postdose|The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model. End Stage Renal Disease for Non-HD Day 9 was not reported since only 24-hour collections were made on that day.||Hours||Geometric Coefficient of Variation|Geometric Mean
656353|NCT01937975|Primary|Time of Maximum Plasma Concentration (Tmax) of Elbasvir|Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10 (all participants) and only up to 24 hours for ESRD participants on Day 9|Up to 120 hours postdose|The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model.||Hours||Full Range|Median
656354|NCT01937975|Primary|Maximum Plasma Concentration (Cmax) of Elbasvir|Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10 (all participants) and only up to 24 hours for ESRD participants on Day 9|Up to 120 hours postdose|The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model.||uM||95% Confidence Interval|Geometric Mean
656355|NCT01937975|Primary|Plasma Concentration at 24 Hours Postdose (C24hr) of Elbasvir|Blood for determination of Elbasvir concentration was collected at 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants)|24 hours postdose|The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model.||nM||95% Confidence Interval|Geometric Mean
656356|NCT01937975|Primary|Area Under the Concentration-time Curve From 0 to 24 Hours Postdose (AUC0-24hr) of Elbasvir|Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants)|Up to 24 hours postdose|The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model.||uM*hr||95% Confidence Interval|Geometric Mean
656357|NCT01937975|Primary|Apparent Volume of Distribution After Extravascular Administration (Vz/F) of Grazoprevir|Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 10|Up to 24 hours postdose|The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model. End Stage Renal Disease for Non-HD Day 9 was not reported since only 24-hour collections were made on that day.||Liters||95% Confidence Interval|Geometric Mean
656358|NCT01937975|Primary|Apparent Clearance After Extravascular Administration (CL/F) of Grazoprevir|Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants)|Up to 24 hours postdose|The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model.||Liters/hr||95% Confidence Interval|Geometric Mean
656359|NCT01937975|Primary|Apparent Terminal Half-life (T1/2) of Grazoprevir|Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10|Up to 120 hours postdose|The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model. End Stage Renal Disease for Non-HD Day 9 was not reported since only 24-hour collections were made on that day.||Hours||Geometric Coefficient of Variation|Geometric Mean
656360|NCT01937975|Primary|Time of Maximum Plasma Concentration (Tmax) of Grazoprevir|Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10 (all participants) and only up to 24 hours for ESRD participants on Day 9|Up to 120 hours postdose|The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model.||Hours||Full Range|Median
656361|NCT01937975|Primary|Maximum Plasma Concentration (Cmax) of Grazoprevir|Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10 (all participants) and only up to 24 hours for ESRD participants on Day 9|Up to 120 hours postdose|The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model.||uM||95% Confidence Interval|Geometric Mean
656362|NCT01937975|Primary|Plasma Concentration at 24 Hours Postdose (C24hr) of Grazoprevir|Blood for determination of Grazoprevir concentration was collected at 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants)|24 hours postdose|The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model.||nM||95% Confidence Interval|Geometric Mean
656363|NCT01937975|Primary|Area Under the Concentration-time Curve From 0 to 24 Hours Postdose (AUC0-24hr) of Grazoprevir|Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants)|Up to 24 hours postdose|The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model.||uM*hr||95% Confidence Interval|Geometric Mean
656364|NCT01937871|Secondary|Change From Baseline in Modified International Prostate Symptom Score (mIPSS) at Week 2|The modified IPSS is the total IPSS collected at 2 weeks post-baseline.The total IPSS is obtained by combining the scores of the responses to component questions 1 through 7. Each question is scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from ANCOVA. The model includes terms for treatment, country/region, prior alpha-blocker use and baseline ED severity (mild/moderate/severe), centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), the centered baseline-by-treatment and the treatment-by-country/region interactions. The interaction terms are removed if p >= 0.10.|Baseline, Week 2|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline mIPSS measurement.||units on a scale||Standard Error|Least Squares Mean
656397|NCT01937715|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax): PF-05212384, Irinotecan, and Fluorouracil|Time to Reach Maximum Observed Plasma Concentration of PF-05212384, Irinotecan, and Fluorouracil|PF-05212384: Cycle 1 Day 3. Irinotecan: Cycle 1 Day 1. Fluorouracil: Cycle 1 Day 1.|Randomized participants (or enrolled participants for Phase 1B) who started treatment and who had at least one of the pharmacokinetic parameters of interest estimated.||hour (hr)||Full Range|Median
656365|NCT01937871|Secondary|Change From Baseline in Yes Responses to Question 3 of the SEP Questionnaire at Week 4 and Week 8|"Participant-assessed diary assesses the mean change from baseline in the percentage of yes responses to SEP Q3, Did your erection last long enough for you to have successful intercourse?. The SEP Q3 score is determined as the percentage of yes responses to SEP Q3 out of all sexual attempts recorded during the time period. Change was defined as the percentage of yes responses at endpoint minus percentage of yes responses at baseline. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment, country/region, baseline ED severity (mild/moderate/severe), centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), the centered baseline-by-treatment and the treatment-by-country/region interactions. The interaction terms are removed if p >= 0.10."|Baseline, Week 4; Baseline, Week 8|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline SEP measurement. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.||"percentage of yes responses"||Standard Error|Least Squares Mean
656366|NCT01937871|Secondary|Change From Baseline in Yes Responses to Question 2 of the SEP Questionnaire at Week 4 and Week 8|"Participant-assessed diary assesses the mean change from baseline in the percentage of yes responses to SEP Q2, Were you able to insert your penis into your partner's vagina?. The SEP Q2 score is determined as the percentage of yes responses to SEP Q2 out of all sexual attempts recorded during the time period. Change was defined as the percentage of yes responses at endpoint minus the percentage of yes responses at baseline. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment, country/region, baseline ED severity (mild/moderate/severe), centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), the centered baseline-by-treatment and the treatment-by-country/region interactions. The interaction terms are removed if p >= 0.10."|Baseline, Week 4; Baseline, Week 8|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline SEP measurement. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.||"percentage of yes responses"||Standard Error|Least Squares Mean
656367|NCT01937871|Secondary|Change From Baseline in IIEF EF at Week 4 and Week 8|IIEF is a 15 item self-reported questionnaire used to assess overall erectile function and satisfaction during the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 were scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 was scored 1 (very low confidence) to 5 (very high confidence) with a total score ranging from 1 to 30. Higher scores represent better erectile function. LS mean of change from baseline to endpoint is from MMRM. The model includes effects for treatment, country/region, baseline LUTS severity (moderate/severe), visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment and treatment-by-country/region interactions. The centered baseline-by-treatment and treatment-by-country interactions was removed if p >= 0.10.|Baseline, Week 4; Baseline, Week 8|All randomized participants who had at least one dose of the study, had a baseline and at least one post-baseline IIEF measurement.||units on a scale||Standard Error|Least Squares Mean
656368|NCT01937871|Secondary|Change From Baseline in Total IPSS at Week 4 and Week 8|IPSS Total Score is the sum of Questions 1 through 7 of the IPSS questionnaire. Each question is scored from 0 (none/no symptoms) to 5 (frequent symptoms) for an IPSS Total Score ranging from 0 to 35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis mixed model for repeated measures (MMRM). The model includes effects for treatment, country/region, prior alpha-blocker therapy, baseline ED severity (mild/moderate/severe),visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment. The centered baseline-by-treatment and treatment-by-country interactions was removed if p >= 0.10.|Baseline, Week 4; Baseline, Week 8|All randomized participants who had at least one dose of the study, had a baseline and at least one post-baseline IPSS measurement.||units on a scale||Standard Error|Least Squares Mean
656369|NCT01937871|Secondary|Change From Baseline in IIEF Subscores at Week 12|IIEF Question 3 asks how often a participant was able to penetrate his partner over the past 4 weeks. Scores range from 0 (did not attempt intercourse) to 5 (almost always or always). IIEF Question 4 asks whether/how often a participant was able to maintain an erection after penetration over the past 4 weeks. Scores range from 0 (did not attempt intercourse) to 5 (almost always or always). Least squares (LS) mean of change from baseline to endpoint is from MMRM. The model includes effects for treatment, country/region, baseline LUTS severity (moderate/severe), visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment and treatment-by-country/region interactions. The centered baseline-by-treatment and treatment-by-country interactions was removed if p >= 0.10.|Baseline, Week 12|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline IIEF measurement.||units on a scale||Standard Error|Least Squares Mean
656370|NCT01937871|Secondary|Change From Baseline in IIEF Sexual Desire at Week 12|IIEF is a 15 item self-reported questionnaire used to assess overall erectile function and satisfaction during the past 4 weeks. IIEF sexual desire is the sum of Q11 and Q12. Scores ranged from 1 (low/almost never) to 5 (very high/almost always) for each question, with the total possible score for the 2 questions ranging from 2 to 10. Higher scores were indicative of increased sexual desire. Least squares (LS) mean of change from baseline to endpoint is from MMRM. The model includes effects for treatment, country/region, baseline LUTS severity (moderate/severe), visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment and treatment-by-country/region interactions. The centered baseline-by-treatment and treatment-by-country interactions was removed if p >= 0.10.|Baseline, Week 12|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline IIEF measurement.||units on a scale||Standard Error|Least Squares Mean
656371|NCT01937871|Secondary|Change From Baseline in IIEF Orgasmic Function at Week 12|IIEF is a 15 item self-reported questionnaire used to assess overall erectile function and satisfaction during the past 4 weeks. IIEF orgasmic function is the sum of Q9 and Q10 of the IIEF. Scores ranged from 0 (no stimulation) to 5 (almost always) for each question, with the total possible score for the 2 questions ranging from 0 to 10. Higher scores were indicative of better orgasmic function. Least squares (LS) mean of change from baseline to endpoint is from MMRM. The model includes effects for treatment, country/region, baseline LUTS severity (moderate/severe), visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment and treatment-by-country/region interactions. The centered baseline-by-treatment and treatment-by-country interactions was removed if p >= 0.10.|Baseline, Week 12|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline IIEF measurement.||units on a scale||Standard Error|Least Squares Mean
656372|NCT01937871|Secondary|Change From Baseline in IIEF Intercourse Satisfaction at Week 12|IIEF is a 15 item self-reported questionnaire used to assess overall erectile function and satisfaction during the past 4 weeks. IIEF-IS is the sum of Questions 6,7 and 8 of the IIEF. Scores range from 0(low/no satisfaction) to 5(high satisfaction) for each question, with the total possible score for the 3 questions ranging from 0 to 15.Higher scores were indicative of an increase in intercourse satisfaction. Least squares (LS) mean of change from baseline to endpoint is from MMRM. The model includes effects for treatment, country/region, baseline LUTS severity (moderate/severe), visit, treatment-by-visit interaction,centered baseline value(defined as the baseline value for a participant- the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment and treatment-by-country/region interactions. The centered baseline-by-treatment and treatment-by-country interactions was removed if p >= 0.10.|Baseline, Week 12|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline IIEF measurement.||units on a scale||Standard Error|Least Squares Mean
656373|NCT01937871|Secondary|Change From Baseline in IIEF Overall Satisfaction (OS) at Week 12|IIEF is a 15 item self-reported questionnaire used to assess overall erectile function and satisfaction during the past 4 weeks. IIEF-OS is the sum of Questions 13 and 14. Scores range from 1 (low/no satisfaction) to 5 (high satisfaction) for each question, with a total subscore ranging from 2 to 10;higher scores represent better erectile function. Least squares (LS) mean of change from baseline to endpoint is from an analysis mixed model for repeated measures (MMRM). The model includes effects for treatment, country/region, baseline LUTS severity (moderate/severe), visit, treatment-by-visit interaction,centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment and treatment-by-country/region interactions. The centered baseline-by-treatment and treatment-by-country interactions was removed if p >= 0.10.|Baseline, Week 12|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline IIEF measurement.||units on a scale||Standard Error|Least Squares Mean
656374|NCT01937871|Secondary|Number of Participants With Clinician Global Impression of Improvement (CGI-I) at Week 12|CGI-I measures clinician's perception of participant improvement at the time of assessment (compared with the start of treatment) with scores ranging from 1 (very much better) to 7 (very much worse).|Week 12|All randomized participants who received at least one dose of the study drug and had a baseline and at least one post-baseline CGI-I measurement.||Participants|||Count of Participants
656375|NCT01937871|Secondary|Number of Participants With Patient Global Impression of Improvement (PGI-I) at Week 12|PGI-I measures a participant's perception of improvement at the time of assessment compared with the start of treatment. Score ranges from 1 (very much better) to 7 (very much worse).|Week 12|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline PGI-I measurement.||Participants|||Count of Participants
656376|NCT01937871|Secondary|Change From Baseline in IPSS Quality of Life (QoL) Index at Week 12|"IPSS QoL assess participant response to the following question:If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?. Response options are Delighted(0),Pleased(1);Mostly satisfied(2);mixed about equally satisfied and dissatisfied(3);Mostly dissatisfied(4);Unhappy(5);Terrible(6),with a total ranging from 0 to 6; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares(LS) mean of change from baseline(bl) to endpoint is from MMRM.The model includes effects for treatment,country/region, prior alpha-blocker therapy,baseline ED severity (mild/moderate/severe),visit, treatment-by-visit interaction, centered bl value (defined as the bl value for a participant -the overall bl mean value),placebo lead-in total IPSS change(change from Visit 2 at Visit 3),centered bl-by-treatment and treatment-by-country/region interactions."|Baseline, Week 12|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline QoL measurement.||units on a scale||Standard Error|Least Squares Mean
656377|NCT01937871|Secondary|Change From Baseline in IPSS Voiding (Obstructive) Subscore at Week 12|IPSS voiding (obstructive) subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores ranged from 0 (no obstructive symptoms) to 5 (frequent obstructive symptoms), with total subscore of the 4 questions of the obstructive score ranging from 0 to 20; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis mixed model for repeated measures (MMRM). The model includes effects for treatment, country/region, prior alpha-blocker therapy, baseline ED severity (mild/moderate/severe),visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment and treatment-by-country/region interactions.|Baseline, Week 12|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline IPSS measurement.||units on a scale||Standard Error|Least Squares Mean
656398|NCT01937715|Secondary|Maximum Observed Plasma Concentration (Cmax): PF-05212384, Irinotecan, and Fluorouracil|Maximum Plasma Concentration of PF-05212384, Irinotecan, and Fluorouracil|PF-05212384: Cycle 1 Day 3. Irinotecan: Cycle 1 Day 1. Fluorouracil: Cycle 1 Day 1.|Randomized participants (or enrolled participants for Phase 1B) who started treatment and who had at least one of the pharmacokinetic parameters of interest estimated.||nanogram (ng)/milliliter (mL)||Geometric Coefficient of Variation|Geometric Mean
656378|NCT01937871|Secondary|Change From Baseline in IPSS Storage (Irritative) Subscore at Week 12|IPSS Storage (Irritative) subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. Scores ranged from 0 (no irritative symptoms) to 5 (frequent irritative symptoms), with total subscore of the 3 questions for irritative subscore ranging from 0 to 15; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis mixed model for repeated measures (MMRM). The model includes effects for treatment, country/region, prior alpha-blocker therapy, baseline ED severity (mild/moderate/severe), visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment and treatment-by-country/region interactions.|Baseline, Week 12|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline IPSS measurement.||units on a scale||Standard Error|Least Squares Mean
656379|NCT01937871|Secondary|Change From Baseline in Postvoid Residual Volume (PVR) at Week 12|The amount of urine remaining in the bladder after void completion.|Baseline, Week 12|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline PVR measurement.||milliliters (mL)||Standard Deviation|Mean
656380|NCT01937871|Secondary|Change From Baseline in Uroflowmetry Measures at Week 12|"Qmax is defined as the peak urine flow rate (measured in milliliters per second [mL/sec] using standard calibrated flowmeter).
At each visit, a uroflowmetry assessment was considered valid and the data were included only if the prevoid total bladder volume (assessed by ultrasound) was >=150 to <=550 milliliters (mL) and the voided volume (Vcomp) was >=125 mL. Changes in Qmax from baseline to endpoint in the double-blind treatment period were analyzed using Type III sums of squares ANOVA on rank-transformed data with a term for treatment group."|Baseline, Week 12|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline Uroflowmetry measurement.||Milliliters/seconds (mL/sec)||Standard Deviation|Mean
656381|NCT01937871|Secondary|Change From Baseline in IPSS at Week 12|IPSS Total Score is the sum of Questions 1 through 7 of the IPSS questionnaire. Each question is scored from 0 (none/no symptoms) to 5 (frequent symptoms) for an IPSS Total Score ranging from 0 to 35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis mixed model for repeated measures (MMRM).The model includes effects for treatment, country/region, prior alpha-blocker therapy, baseline Erectile dysfunction (ED) severity (mild/moderate/severe),visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment. The centered baseline-by-treatment and treatment-by-country interactions was removed if p >= 0.10.|Baseline, Week 12|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline IPSS measurement.||units on a scale||Standard Error|Least Squares Mean
656382|NCT01937871|Secondary|Change From Baseline in Yes Responses to Question 3 of the SEP Questionnaire at Week 12|"Participant-assessed diary assesses the mean change from baseline in the percentage of yes responses to SEP Q3, Did your erection last long enough for you to have successful intercourse?.The SEP Q3 score is determined as the percentage of yes responses to SEP Q3 out of all sexual attempts recorded during the time period. Change was defined as the percentage of yes responses at endpoint minus percentage of yes responses at baseline. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment, country/region, baseline ED severity (mild/moderate/severe), centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), the centered baseline-by-treatment and the treatment-by-country/region interactions. The interaction terms are removed if p >= 0.10."|Baseline, Week 12|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline SEP measurement. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.||"percentage of yes responses"||Standard Error|Least Squares Mean
656383|NCT01937871|Secondary|Change From Baseline in Yes Responses to Question 2 of the Sexual Encounter Profile (SEP) Questionnaire at Week 12|"Participant-assessed diary assesses the mean change from baseline in the percentage of yes responses to SEP Q2, Were you able to insert your penis into your partner's vagina?. The SEP Q2 score was determined as the percentage of yes responses to SEP Q2 out of all sexual attempts recorded during the time period. Change is defined as the percentage of “yes” responses at endpoint minus the percentage of “yes” responses at baseline. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment, country/region, baseline ED severity (mild/moderate/severe), centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), the centered baseline-by-treatment and the treatment-by-country/region interactions. The interaction terms are removed if p >= 0.10."|Baseline, Week 12|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline SEP measurement. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.||"percentage of yes responses"||Standard Error|Least Squares Mean
656384|NCT01937871|Secondary|Change From Baseline in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain at Week 12|IIEF is a 15 item self-reported questionnaire to assess overall erectile function and satisfaction during the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0(low/no erectile function) to 5(high erectile function) and Question 15 is scored 1(very low confidence) to 5(very high confidence) with a total score ranging from 1 to 30.Higher scores represent better erectile function.LS mean of change from baseline to endpoint is from MMRM.The model includes effects for treatment,country/region,baseline lower urinary tract symptoms(LUTS) severity (moderate/severe),visit,treatment-by-visit interaction,centered baseline value(defined as the baseline value for a participant-the overall baseline mean value), placebo lead-in total IPSS change(change from Visit 2 at Visit 3),centered baseline-by-treatment and treatment-by-country/region interactions.The centered baseline-by-treatment and treatment-by-country interactions was removed if p >= 0.10.|Baseline, Week 12|All randomized participants who had at least one dose of the study drug, had a baseline and at least one post-baseline IIEF measurement.||units on a scale||Standard Error|Least Squares Mean
656385|NCT01937871|Primary|Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12|IPSS Total Score is the sum of Questions 1 through 7 of the IPSS questionnaire. Each question was scored from 0 (none/no symptoms) to 5 (frequent symptoms) for an IPSS Total Score ranging from 0 to 35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis mixed model for repeated measures (MMRM).The model includes effects for treatment, country/region, prior alpha-blocker therapy, baseline Erectile dysfunction (ED) severity (mild/moderate/severe),visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment.The centered baseline-by-treatment and treatment-by-country interactions was removed if p >= 0.10.|Baseline, Week 12|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline IPSS measurement.||units on a scale||Standard Error|Least Squares Mean
656386|NCT01937715|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Colorectal (FACT-C) (Phase 2)|The FACT-C was to assess health-related quality of life and colorectal cancer (CRC)-related symptoms. It includes a total of 36 items, which are summarized into 6 subscales: physical well-being (7 items), functional well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), CRC subscale (9 items) which addresses a subset of CRC concerns such as diarrhea.|Day 1 of each cycle|FACT-C was only applicable to the Phase 2 portion of the study. As this study was terminated due to Pfizer portfolio prioritization prior to the Phase 2 portion, no data were collected for Phase 2.|||||
656387|NCT01937715|Secondary|Number of Participants With Evidence of Pathway Signaling Related Genes and/or Proteins in Biopsied Tumor Tissue (Phase 2)|Biomarker evaluation were to be performed on these fresh biopsies, as well as on archival biopsies collected during the study. Samples were to be analyzed for biomarkers indicative of pathway modulation or for genetic markers correlated to drug sensitivity.|Baseline and Cycle 2 Day 17|Levels of signaling proteins in biopsied tumor tissue was the secondary endpoint for the Phase 2 portion of the study. As this study was terminated due to Pfizer portfolio prioritization prior to the Phase 2 portion, no data were collected for Phase 2.|||||
656388|NCT01937715|Secondary|Overall Survival (Phase 2)|Overall survival is the time from randomization date to date of death due to any cause.|Day 1 up to Day 28|As this study was terminated due to Pfizer portfolio prioritization prior to the Phase 2 portion, there are no efficacy evaluations for Phase 2. No data were collected for Phase 2.|||||
656389|NCT01937715|Secondary|Duration of Response (Phase 2)|Duration of response is the time from first documentation of CR or PR to date of first documentation of objective progression or death.|Day 1 to Day 28|As this study was terminated due to Pfizer portfolio prioritization prior to the Phase 2 portion, there are no efficacy evaluations for Phase 2. No data were collected for Phase 2.|||||
656390|NCT01937715|Secondary|Number of Participants With Best Overall Response (Phase 2)|Best overall response is defined as the best response recorded from randomization (or first dose for patients in the Phase 1B) until disease progression, death, start of new anti-cancer treatment or end of study. The categories for best overall response include: complete response (CR) (complete disappearance of all target lesions with the exception of nodal disease and all target nodes must decrease to normal size (short axis <10 millimeters (mm)); partial response (PR) (at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters); stable disease (SD) (not qualify for CR, PR or Progression); progressive disease (PD) (20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm); indeterminate (IND) (progression has not been documented).|Day 1 up to Day 28|As this study was terminated due to Pfizer portfolio prioritization prior to the Phase 2 portion, there are no efficacy evaluations for Phase 2. No data were collected for Phase 2.|||||
656391|NCT01937715|Secondary|Number of Participants With Gene and/or Protein Expression Biomarkers Relating to the PI3K and/or mTOR Pathway Activation in Biopsied Tumor Tissue|Biomarker evaluation were to be performed on fresh biopsies, as well as on archival biopsies collected during the study. Samples were to be analyzed for biomarkers indicative of pathway modulation or for genetic markers correlated to drug sensitivity.|Baseline and Cycle 2 Day 17|Paired fresh tumor biopsies were only done in 1 subject but not summarized.|||||
656392|NCT01937715|Secondary|Number of Participants With Expression of Gene Sequences or Gene Amplications in Biopsied Tumor Tissue|Biomarker evaluation were to be performed on fresh biopsies, as well as on archival biopsies collected during the study. Samples were to be analyzed for biomarkers indicative of pathway modulation or for genetic markers correlated to drug sensitivity.|Baseline and Cycle 2 Day 17|Paired fresh tumor biopsies were only done in 1 subject but not summarized.|||||
656393|NCT01937715|Secondary|Number of Participants Meeting Maximum Post-Baseline QTc Interval Values|Criteria for corrected QT interval using Fridericia's formula (QTcF) meeting potential clinical concern included: an absolute value >=450 - <480 msec, >=480-<500 msec, >500 msec; an absolute change 30 - <60, >=60 msec.|Baseline, Cycle 1 Day 1, and Cycle 2 Day 2|All participants who received at least 1 dose of study medication.||participants|||Number
656394|NCT01937715|Secondary|Terminal Elimination Half-Life (t1/2): PF-05212384 and Irinotecan|Terminal Elimination Half-Life of PF-05212384 and Irinotecan|PF-05212384: Cycle 1 Day 3. Irinotecan: Cycle 1 Day 1.|Randomized participants (or enrolled participants for Phase 1B) who started treatment and who had at least one of the pharmacokinetic parameters of interest estimated.||hour||Standard Deviation|Mean
656395|NCT01937715|Secondary|Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf): PF-05212384 and Irinotecan|Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time of PF-05212384 and Irinotecan|PF-05212384: Cycle 1 Day 3. Irinotecan: Cycle 1 Day 1.|Randomized participants (or enrolled participants for Phase 1B) who started treatment and who had at least one of the pharmacokinetic parameters of interest estimated.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
656396|NCT01937715|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast): PF-05212384 and Irinotecan|Area Under the Curve From Time Zero to Last Quantifiable Concentration of PF-05212384, and Irinotecan|PF-05212384: Cycle 1 Day 3. Irinotecan: Cycle 1 Day 1.|Randomized participants (or enrolled participants for Phase 1B) who started treatment and who had at least one of the pharmacokinetic parameters of interest estimated.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
656399|NCT01937715|Secondary|Number of Participants With Urinalysis Test Abnormalities|Number of participants with NCI CTCAE version 4.0 grade 1 to 4 Urinalysis test abnormalities.|Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2 and subsequent cycles|All participants who received at least 1 dose of study medication.||participants|||Number
656400|NCT01937715|Secondary|Number of Participants With Chemistry Test Abnormalities|Number of participants with NCI CTCAE version 4.0 grade 1 to 4 Chemistry test abnormalities.|Day 1 and Day 15 of each cycle|All participants who received at least 1 dose of study medication. n=number of participants evaluated against criteria.||participants|||Number
656401|NCT01937715|Secondary|Number of Participants With Coagulation Test Abnormalities|Number of participants with NCI CTCAE version 4.0 grade 1 to 4 Coagulation test abnormalities.|Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2 and subsequent cycles|All participants who received at least 1 dose of study medication. n=number of participants evaluated against criteria.||participants|||Number
656402|NCT01937715|Secondary|Number of Participants With Hematological Test Abnormalities|Number of participants with NCI CTCAE version 4.0 grade 1 to 4 hematological test abnormalities.|Day 1 and Day 15 of each cycle|All participants who received at least 1 dose of study medication.||participants|||Number
656403|NCT01937715|Secondary|Number of Participants With Treatment-Emergent AEs by Worst On-Study Grade|An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. AE grades were defined according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 criteria.|Baseline up to final study evaluation (within 28 days of last dose)|All participants who received at least 1 dose of study medication.||participants|||Number
656404|NCT01937715|Secondary|Number of Participants With All Causality AEs by System Organ Class (SOC)|An AE was any untoward medical occurrence without regard to causality in a participant who received study drug.|Baseline up to final study evaluation (within 28 days of last dose)|All participants who received at least 1 dose of study medication.||participants|||Number
656405|NCT01937715|Secondary|Number of Participants With All Causality Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations by Relationship and Seriousness|An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. An AE was considered treatment emergent if the event occurred for the first time after the start of study treatment and within 28 days after final dose of study treatment and was not seen prior to the start of treatment; or the event was seen prior to the start of treatment but increased in CTCAE version 4.0 grade after the start of study treatment and within 28 days after final dose of study treatment.|Baseline up to final study evaluation (within 28 days of last dose)|All participants who received at least 1 dose of study medication.||participants|||Number
656406|NCT01937715|Secondary|Number of Participants With Best Overall Response (Phase 1B)|Best overall response is defined as the best response recorded from randomization (or first dose for patients in the Phase 1B) until disease progression, death, start of new anti-cancer treatment or end of study. The categories for best overall response include: complete response (CR) (complete disappearance of all target lesions with the exception of nodal disease and all target nodes must decrease to normal size (short axis <10 millimeters (mm)); partial response (PR) (at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters); stable disease (SD) (not qualify for CR, PR or Progression); progressive disease (PD) (20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm); indeterminate (IND) (progression has not been documented).|Every 8 weeks from Cycle 1 Day 1 until 28 days of last dose|All participants in the full analysis (FA) set who had measureable disease and an adequate baseline assessment of the disease.||participants|||Number
656407|NCT01937715|Primary|Progression-Free Survival (PFS)|Progression-free survival was the time from randomization the date to date of first documentation of progression or death due to any cause, whichever occurred first. Documentation of progression was by objective disease assessment as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.|Baseline (Day 1) up to disease progression or death whichever occurred first (up to 18 months)|PFS was the primary efficacy endpoint for the study and was only to be assessed in the Phase 2 portion of the study. As this study was terminated due to Pfizer portfolio prioritization prior to the Phase 2 portion, there are no efficacy evaluations for Phase 2.|||||
656408|NCT01937715|Primary|Percentage of Participants With Dose-Limiting Toxicities (DLTs) in First Cycle of Therapy|DLTs were classified according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 and defined as any of the following events judged to be attributed to the combination of PF-05212384 plus FOLFIRI: hematologic (febrile neutropenia or a sustained temperature >=38 degrees Celcius for >1 hour, grade >=3 neutropenic infection, grade 3 thrombocytopenia with bleeding, grade 4 thrombocytopenia); non-hematologic (grade >=2 pneumonitis, grade >=3 toxicities, toxicities which resulted in failure to deliver at least 75% of the planned total dose of PF-05212384 and/or 50% of the planned total dose of FOLFIRI during the first cycle, toxicities which resulted in delay of start of Cycle 2 by >2 weeks of scheduled day (Day 43 of study), Grade 3 QTc prolongation).|Day 1 up to Day 28|The dose limiting toxicity analysis set included participants in Phase 1B who started treatment and who did not have a major treatment deviation in the lead-in period and the first cycle of treatment.||percentage of participants|||Number
656409|NCT01937598|Secondary|AUC Active GIP||Approximately 6 weeks (range 9 - 60 days / 8.5 weeks)|||pmol/l*min||Standard Error|Mean
656410|NCT01937598|Secondary|AUC Active GLP-1||Approximately 6 weeks (range 9 - 60 days / 8.5 weeks)|||pmol/l*min||Standard Error|Mean
656411|NCT01937598|Secondary|AUC Total GIP||Approximately 6 weeks (range 9 - 60 days / 8.5 weeks)|||pmol/l*min||Standard Error|Mean
656412|NCT01937598|Secondary|AUC Total GLP-1||Approximately 6 weeks (range 9 - 60 days / 8.5 weeks)|||pmol/l*min||Standard Error|Mean
656413|NCT01937598|Secondary|AUC Glucagon||Approximately 6 weeks (range 9 - 60 days / 8.5 weeks)|||pmol/l*min||Standard Error|Mean
656414|NCT01937598|Secondary|AUC C-peptide||Approximately 6 weeks (range 9 - 60 days / 8.5 weeks)|||nmol/l*min||Standard Error|Mean
656415|NCT01937598|Secondary|AUC Insulin||Approximately 6 weeks (range 9 - 60 days / 8.5 weeks)|||nmol/l*min||Standard Error|Mean
656417|NCT01937598|Primary|Incremental Area Under the Plasma Glucose (BG) Concentration-time Profile (AUC)|Incremental area under the plasma glucose (BG) concentration-time profile (AUC) immediately before to 300 min after a mixed meal test. In addition, the time course of BG values will be analysed with an ANCOVA model for repeated measurements with placebo baseline values as covariate. Time points to create the curce were 0, 15, 30, 45, 60, 90, 120, 150, 180, 240 and 300 minutes post mixed meal test.|0 to 300 min post mixed meal test|||[mg*min/dL]||Standard Error|Mean
656418|NCT01937520|Secondary|Serum Insulin Level|to determine if electroacupuncture reduced hyperglycemia|preoperative and postoperative|female subjects preoperatively and postoperatively||pg/ml||Standard Error|Mean
656419|NCT01937520|Secondary|TGFB1|TGFB1 is a pleiotropic factor regulating the immune system and healing. First two blood samples drawn under general anesthesia, first prior to surgical incision and EA, the 2nd 60 minutes after incision and EA, third after arrival in PACU but before administration of analgesia.|Preoperatively-intraoperatively-postoperatively|all females; then females by groups age (<45 years and >45 years) and weight (<75kg and >75kg)||pg/ml||Standard Error|Mean
656420|NCT01937520|Secondary|IL-10|IL-10 is an anti-inflammatory cytokine marker. First two blood samples were collected during general anesthesia, first prior to surgical incision and EA, 2nd 60 minutes following incision and EA, and the third after arrival in PACU but before administration of analgesia.|Preoperatively-intraoperatively-postoperatively|total females; then those grouped by age (<45years and>45 years) and weight (<75 Kg and >75kg)||pg/ml||Standard Error|Mean
656421|NCT01937520|Secondary|IL-6|First two blood samples were collected during general anesthesia, first prior to Surgical incision and EA, 2nd 60 minutes after incision and EA and the 3rd after arrival in PACU but before administration of analgesia. IL-6 is a critical inflammatory cytokine produced during the acute phase of reaction to trauma|Preoperatively-intraoperatively-postoperatively|total female results; then females divided into age groups (<45 or >45years) and weights groups (<75kg and >75kg)||pg/ml||Standard Error|Mean
656422|NCT01937520|Secondary|iNTERLEUKIN (IL-2 and IL-4)|both are IL-2 and IL-4 are critical cytokines regulating the cellular response to induce cellular versus hormone immunity. First two blood samples were collected during general anesthesia: first prior to surgical incision and electroacupuncture, second 60 minutes after incision and electroacupuncture and the 3rd after arrival in PACU but before analgesia.|Preoperatively-intraoperatively-postoperatively|all females||pg/ml||Standard Error|Mean
656423|NCT01937520|Secondary|Tumor Necrosis Factor (TNF)|First two blood samples were collected during general anesthesia, first prior to surgical incision and Electro-acupuncture (EA), 2nd 60 minutes after incision and EA, third after arrival in PACU but before administration of analgesia. TNF is a critical pyrogen produced during acute phase of a reaction to trauma.|preoperatively-intraoperatively-postoperatively|female subjects||pg/ml||Standard Error|Mean
656424|NCT01937520|Secondary|Glucose|the first two blood samples were collected during general anesthesia, the first prior to surgical incision and electroacupuncture, the second 60 minutes after incision time and at the completion of electroacupuncture, the third after arrival in PACU but before the administration of analgesia.|serum glucose from baseline to PACU arrival|females||mg/dL||Standard Error|Mean
656425|NCT01937520|Primary|Pain Levels|Visual Acuity scale 0=no pain 10= worst pain possible|PACU, day 1 , day 2, day 3|female patients self reported pain experience following surgery||units on a scale||Standard Error|Mean
656426|NCT01937520|Primary|Morphine Equivalent|equivalent doses of morphine for analgesic relief. All analgesic treatments were converted to morphine equivalents in milligrams.|PACU, day 1 , day 2, day 3|since gender impacts the threshold for analgesic and pain the effects of electroacupuncture on females was analyzed. The same number of females were in both groups but since one subject had preexisting levels of TNF>1ug/ml prior to surgery she was eliminated from the dta base||mg morphine||Standard Error|Mean
656427|NCT01937520|Secondary|Cortisol|All blood samples were collected during general anesthesia, the first prior to surgical incision and electroacupuncture, the second 60 minutes after incision time and at the completion of electroacupuncture, the third after arrival in PACU but before the administration of analgesia.|prior to surgical incision, 1 hour following incision, after arrival in PACU|females||ng/ml||Standard Error|Mean
656428|NCT01937520|Secondary|Modified Quality of Recovery Scale|Modified patient self reported scale with 9 questions regarding general well being including ability to eat, free from constant pain, able to manage activities of daily living. 0= worst possible score and 18=best outcome score|Day 1, 2, 3|all females||units on a scale||Standard Error|Mean
656429|NCT01937520|Secondary|Morphine Equivalent (mg)|morphine equivalent to analyze whether body weight affected the efficacy of electroacupuncture|PACU arrival to 2 hours post op|females with body weight <75 kg and >than 75 kg||mg morphine||Standard Error|Mean
656430|NCT01937520|Secondary|Morphine Equivalent|All analgesic treatments were converted to morphine equivalents in milligrams .|PACU to 2 hours post op|females grouped by age (<45 years and 45 years or greater)||mg of Morphine||Standard Error|Mean
656431|NCT01937520|Secondary|(ACTH )Adrenocorticotropic Hormone|All blood samples were collected during general anesthesia, the first prior to surgical incision and electroacupuncture, the second 60 minutes after incision time and at the completion of electroacupuncture, the third after arrival in PACU but before the administration of analgesia. The data below represents female patients only|serum ACTH from baseline/preoperatively,intraoperatively, upon arrival in PACU|females||pg/ml||Standard Error|Mean
656432|NCT01937520|Primary|Visual Acuity Score (VAS)|VAS is a self reported pain scale with a score ranging from 0 to 10. 0= no pain, 10=worst pain possible. Multiple pain sacores were recorded. single value is reported by average|arrival in PACU to 2 hours post operatively|all study participants||units on a scale||Standard Error|Mean
656433|NCT01937520|Primary|Reduced Pain Medication Requirement|analgesia provided in Post Anesthesia Care Unit PACU)|amount of pain medication provided in PACU|All subjects enrolled in study||mg of Morphine||Standard Error|Mean
656434|NCT01937364|Secondary|Peak and Total Benzodiazepine Dose Required||72 hours|||Doses||Inter-Quartile Range|Median
656435|NCT01937364|Secondary|Severity of Alcohol Withdrawal Symptoms as Measured on the CIWA-Ar Scale and Assessed at 24, 48, and 72 Hours After Enrollment|Range: 0 to 67; larger values indicate greater severity|72 hours|All CIWA-Ar scores collected at and after the baseline measurement.||units on a scale||Standard Error|Mean
657595|NCT01919229|Secondary|Correlation Between PK Concentrations and ECG Changes|Correlation between the QTc interval change from baseline and plasma concentrations of LEE011 and/or any relevant metabolites|Day 14|Since the study was terminated, no efficacy data was obtained.|||||
656436|NCT01937364|Primary|Moderate or Severe Alcohol Withdrawal Syndrome|Moderate or severe AWS was defined as a CIWA-AR score of at least 11.|72 hours|Subjects who either had AWS prior to the collection of the 72-hour CIWA-Ar score or had a CIWA-Ar score either recorded as the 72-hour CIWA-Ar score or occurring within the one-hour window for the 72-hour CIWA-Ar score are evaluable for this endpoint.||Participants|||Count of Participants
656437|NCT01937351|Secondary|Secondary Effectiveness Endpoint|Changes in Quality of Life measures from Baseline at 30 days and 6 months using Short Form (SF)-12 & Vascular Quality of Life (VascuQoL).|Day 0, Day 60 and 6 Months||04/2017||||
656438|NCT01937351|Secondary|Secondary Effectiveness Endpoint|Rutherford Classification at 30 days and 6 months.|Day 0, Day 30 and 6 Months||||||
656439|NCT01937351|Secondary|Secondary Effectiveness Endpoint|Ankle-Brachial Index at 30 days and 6 months.|Day 30 and 6 Months||||||
656440|NCT01937351|Secondary|Secondary Effectiveness Endpoint|Procedural success defined as the percent of target lesions that have residual diameter stenosis < 30% post-Pantheris and any other adjunctive therapy, determined by independent Angiographic Core Laboratory.|Day 0||||||
656441|NCT01937351|Secondary|Secondary Safety Endpoint|Freedom from clinically driven Target Vessel Revascularization (TVR) through 6 months, as adjudicated by an independent CEC.|Day 0 through 6 Months||04/2017||||
656442|NCT01937351|Secondary|Secondary Safety Endpoint|Freedom from procedural emboli, defined as a change in any visualized runoff vessel (other than vasospasm and dissection) at any time during the procedure.|Day 0||||||
656443|NCT01937351|Secondary|Secondary Safety Endpoint|Freedom from MAEs as defined above, through 30 days (or hospital discharge, whichever is longer) as adjudicated by an independent CEC.|Day 0 through Day 30|||percentage of subjects|||Number
656444|NCT01937351|Primary|Primary Effectiveness Endpoint|The primary efficacy endpoint of technical success is defined as the percent of target lesions that have a residual diameter stenosis <50% post the Pantheris device alone, as assessed by an independent Angiographic Core Laboratory.|Day 0|Analysis was performed on per protocol cohort, and results were calculated based on number of lesions that were treated.||percentage of lesions|lesions||Number
656445|NCT01937351|Primary|Primary Safety Endpoint|"The primary safety endpoint is defined as freedom from a composite of major adverse events (MAE) through 6-Month follow-up as adjudicated by an independent Clinical Events Committee (CEC). Individual MAEs include:
Cardiovascular related death
Unplanned, major index limb amputation
Clinically driven target lesion revascularization (TLR)
Myocardial infarction
Device related events:
Clinically significant perforation
Clinically significant dissection
Clinically significant embolus
Pseudoaneurysm"|Day 0 through 6 Months|All per-protocol subjects who completed the 6-month follow-up were included in the analysis||percentage of subjects|||Number
656446|NCT01937312|Secondary|Mean IOP at Week 6 for Each Time Point (8 AM, 10 AM, 3 PM, 5 PM)|IOP was assessed using Goldmann applanation tonometry and reported in mmHg. One eye was chosen as the study eye and only data for the study eye were used for the analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).|Week 6|This analysis population includes all subjects who received study medication and completed at least 1 scheduled on-therapy visit (intent-to-treat). Last observation carried forward (LOCF) was not utilized; therefore, results report subjects present at Week 6 with no imputation for missingness.||mmHg||Standard Deviation|Mean
656447|NCT01937312|Secondary|Mean Diurnal IOP Percentage Change From Baseline to Week 6|Baseline IOP was defined as the average of the timepoint-matched IOP measurements at Eligibility 1 and Eligibility 2 Visits. Diurnal IOP Percentage Change was defined as the average of the four percent changes from baseline (timepoints 8 AM, 10 AM, 3 PM, and 5 PM). IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). One eye was chosen as the study eye and only data for the study eye were used for the analysis. A more negative percent change from baseline indicates a greater amount of improvement, i.e., a reduction of IOP.|Baseline, Week 6|This analysis population includes all subjects who received study medication and completed at least 1 scheduled on-therapy visit (intent-to-treat). Last observation carried forward (LOCF) was not utilized; therefore, results report subjects present at Week 6 with no imputation for missingness.||percent change||Standard Deviation|Mean
656448|NCT01937312|Secondary|Mean Diurnal IOP Change From Baseline to Week 6|Baseline IOP was defined as the average of the timepoint-matched IOP measurements at Eligibility 1 and Eligibility 2 Visits. Diurnal IOP change was defined as the average of the four changes from baseline (timepoints 8 AM, 10 AM, 3 PM, and 5 PM). IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). One eye was chosen as the study eye and only data for the study eye were used for the analysis. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP.|Baseline, Week 6|This analysis population includes all subjects who received study medication and completed at least 1 scheduled on-therapy visit (intent-to-treat). Last observation carried forward (LOCF) was not utilized; therefore, results report subjects present at Week 6 with no imputation for missingness.||mmHg||Standard Deviation|Mean
656449|NCT01937312|Primary|Mean Diurnal Intraocular Pressure (IOP) at Week 6|Diurnal IOP was defined as the average of the four timepoints measured (8 AM, 10 AM, 3 PM, and 5 PM). IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). One eye was chosen as the study eye and only data for the study eye were used for the analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).|Week 6|This analysis population includes all subjects who received study medication and completed at least 1 scheduled on-therapy visit (intent-to-treat). Last observation carried forward (LOCF) was not utilized; therefore, results report subjects present at Week 6 with no imputation for missingness.||mmHg||Standard Deviation|Mean
656463|NCT01937130|Secondary|Levels of Caspase 3/7 RLU|Concentration of Caspase 3/7 Relative Light Units|Baseline, Day 2, Day 4, Day 7, Day 14, Day 21, and Day 28|"Number of subjects analyzed varied by time point; Day2: 5 and 25 arms are 4 and 6; Day4: 25 and placebo arms are 6 and 2; Day7: 25 arm is 6; Day14: 5, 25, 50, and placebo arms are 2, 5, 3, and 2; Day21: 5, 25, 50, and placebo arms are 2, 3, 2, and 2; Day28: 5, 25, 50, and placebo arms are 0, 3, 2, and 2; 0 are non-estimable values"||RLU||Inter-Quartile Range|Median
656766|NCT01930487|Secondary|Change in Ophthalmic Artery Blood Flow - Vascular Resistance (Ratio) - DM|change (post-treatment - pre-treatment) in ophthalmic artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients with type 2 diabetes|baseline and 30 days|patients completing both study periods||ratio||Standard Error|Mean
656450|NCT01937299|Secondary|Mean Diurnal IOP Percentage Change From Baseline to Week 6|Baseline IOP was defined as the average of the timepoint-matched IOP measurements at Eligibility 1 and Eligibility 2 Visits. Diurnal IOP Percentage Change was defined as the average of the four percent changes from baseline (timepoints 8 AM, 10 AM, 3 PM, and 5 PM). IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). One eye was chosen as the study eye and only data for the study eye were used for the analyses. A more negative percent change from baseline indicates a greater amount of improvement, i.e., a reduction of IOP.|Baseline, Week 6|This analysis population includes all subjects who received study medication and completed at least 1 scheduled on-therapy study visit. Last observation carried forward (LOCF) was not utilized; therefore results report subjects present at Week 6 with no imputation for missingness.||percent change||Standard Deviation|Mean
656451|NCT01937299|Secondary|Mean Diurnal IOP Change From Baseline to Week 6|Baseline IOP was defined as the average of the timepoint-matched IOP measurements at Eligibility 1 and Eligibility 2 Visits. Diurnal IOP change was defined as the average of the four changes from baseline (timepoints 8 AM, 10 AM, 3 PM, and 5 PM). IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). One eye was chosen as the study eye and only data for the study eye were used for the analyses. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP.|Baseline, Week 6|This analysis population includes all subjects who received study medication and completed at least 1 scheduled on-therapy study visit. Last observation carried forward (LOCF) was not utilized; therefore results report subjects present at Week 6 with no imputation for missingness.||mmHg||Standard Deviation|Mean
656452|NCT01937299|Primary|Mean Diurnal Intraocular Pressure (IOP) at Week 6|Diurnal IOP was defined as the average of the four timepoints measured (8 AM, 10 AM, 3 PM, and 5 PM). IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). One eye was chosen as the study eye and only data for the study eye were used for the analyses. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).|Week 6|This analysis population includes all subjects who received study medication and completed at least 1 scheduled on-therapy study visit. Last observation carried forward (LOCF) was not utilized; therefore results report subjects present at Week 6 with no imputation for missingness.||mmHg||Standard Deviation|Mean
656453|NCT01937260|Primary|The Area Under the Drug-concentration Curve of Midazolam After a Single Dose of Brodalumab From Zero Tot he Last Time of Quantifiable Concentration|Midazolam pharmacokinetic parameter estimates after single oral dose of Midazolam 2 mg on Day 1 and Day 9 and a single administration of Brodalumab 210 mg on Day 2|Day 1 to Day 9|20 subjects are now analyzed after the discontinuation of 1 subject by sponsor decision||hr*ng/mL||Standard Deviation|Mean
656454|NCT01937260|Primary|The Area Under Drug Concentration Time Curve From Zero to Infinity (AUCinf)|Midazolam pharmacokinetic parameter estimates after single oral dose of Midazolam 2 mg on Day 1 and Day 9 and a single administration of Brodalumab 210 mg on Day 2 with PK sampling collected on day 30|Day 1 to Day 9|20 subjects analyzed after the discontinuation of 1 subject by sponsor decision||hr*ng/mL||Standard Deviation|Mean
656455|NCT01937260|Primary|The Maximum Observed Concentration of Midazolam After a Single Dose of Brodalumab|Midazolam pharmacokinetic parameter estimates after single oral dose of Midazolam 2 mg on Day 1 and Day 9 and a single administration of Brodalumab 210 mg on Day 2 with PK sampling collected on Day 30|Day 1 to day 9|Analysis population is now 20 subjects after 1 subject was discontinued by sponsor decision||nanograms per milliliter||Standard Deviation|Mean
656456|NCT01937195|Secondary|"Percentage of Patients Who Identified as Satisfied With Catheter Performance at Catheter Removal"|Patients were surveyed regarding satisfaction with catheter performance with a 5-point Likert scale (1 the lowest, 5 the highest). Satisfaction was defined as a score of 3 to 5.|At catheter removal, which is expected to be up to 7 days post placement|Inpatients requiring IV therapy||percentage of participants||95% Confidence Interval|Number
656457|NCT01937195|Secondary|Number of Participants Experiencing Adverse Events|Will measure the number and severity of adverse events associated with peripheral IV initiation and indwelling catheter time up to 7 days. Adverse events are anticipated complications of IV therapy.|baseline, and up to catheter removal expected to be no more than 7 days post placement|Inpatients requiring IV therapy.||participants|||Number
656458|NCT01937195|Secondary|"Percentage of Patients Who Identified as Satisfied With Catheter Performance at Catheter Insertion"|Patients were surveyed regarding satisfaction with catheter insertion with a 5-point Likert scale (1 the lowest, 5 the highest). Satisfaction was defined as a score of 3 to 5.|Baseline at catheter insertion in the first 3-15 minutes after procedure|Inpatients requiring IV therapy||percentage of participants||95% Confidence Interval|Number
656459|NCT01937195|Secondary|Catheter Dwell Time|Will measure total catheter dwell time to the nearest hour (total time in hours for functioning catheter) up to 7 days.|Study exit/at catheter removal expected to be up to 7 days post placement|||hours||95% Confidence Interval|Mean
656460|NCT01937195|Secondary|Completion of IV Therapy|Completion of IV therapy will measure whether the catheter remained in place for the duration of required intravenous treatment during the inpatient stay (generally up to 7 days).|Study exit/at catheter removal expected to be up to 7 days post placement|Inpatients requiring IV therapy.||Participants|||Count of Participants
656461|NCT01937195|Secondary|Percentage of Patients With Complications of Peripheral IV Therapy|Will measure the percentage of patients with (anticipated) complications of IV therapy - infection, occlusion, infiltration, extravasation, phlebitis, dislodgement, leaking/bleeding at site, patient complaints of pain without other identifiable cause, and other (up to 7 days).|Study exit/at catheter removal expected to be up to 7 days post placement|Inpatient units requiring IV therapy.||percentage of patients||95% Confidence Interval|Number
656462|NCT01937195|Primary|Percentage of Participants With Successfully Inserted Peripheral IV Catheter Placement on First Attempt|The primary endpoint is to observe the rate of first attempt success (where the inserter only pierces the skin once and successfully places the PIV catheter in the vein) in patients requiring PIV access.|Baseline/at catheter placement, usually 3-15 minutes initial during insertion procedure|Inpatients requiring IV therapy.||percentage of participants||95% Confidence Interval|Number
656519|NCT01935180|Secondary|Real Time Prediction of Polyp Histology|Difference in recommended surveillance interval between real time polyp diagnosis and pathological diagnosis among patients with at least one diminutive polyp|1 year|||Participants|||Count of Participants
656464|NCT01937130|Secondary|Levels of CK18/M65|Caspase full-length cytokeratin serum levels CK18/M65|Baseline, Day 2, Day 4, Day 7, Day 14, Day 21, and Day 28|"Number of subjects analyzed varied by time point; Day2: 5 and 25 arms are 4 and 6; Day4: 25 and placebo arms are 6 and 2; Day7: 25 arm is 6; Day14: 5, 25, 50, and placebo arms are 2, 5, 3, and 2; Day21: 5, 25, 50, and placebo arms are 2, 3, 2, and 2; Day28: 5, 25, 50, and placebo arms are 0, 3, 2, and 2; 0 are non-estimable values"||U/L||Inter-Quartile Range|Median
656465|NCT01937130|Secondary|Levels of CK18/M30|Caspase-cleaved cytokeratin serum levels (CK18/M30)|Baseline, Day 2, Day 4, Day 7, Day 14, Day 21, and Day 28|"Number of subjects analyzed varied by time point; Day2: 5 and 25 arms are 4 and 6; Day4: 25 and placebo arms are 6 and 2; Day7: 25 arm is 6; Day14: 5, 25, 50, and placebo arms are 2, 5, 3, and 2; Day21: 5, 25, 50, and placebo arms are 2, 3, 2, and 2; Day28: 5, 25, 50, and placebo arms are 0, 3, 2, and 2; 0 are non-estimable values"||U/L||Inter-Quartile Range|Median
656466|NCT01937130|Primary|Tmax & t1/2 Parameters|Primary endpoints for tmax & t1/2 on Day 1 and Day 4 for the active treatment arms were analyzed.|28 Days|"t1/2 number of participants analyzed at Day 1 in the 5mg arm was 2 and 1 at Day 4, in the 25mg arm was 5 at Day 1 and 2 at Day 4, in the 50mg arm was 2 at Day 1 and 3 at Day 4.
Values listed as 0 were non-estimable values."||(h)|Participants|Standard Deviation|Mean
656467|NCT01937130|Primary|Cmax|Primary endpoints forCmax on Day 1 and Day 4 for the active treatment arms were analyzed.|28 Days|||(ng/mL)|Participants|Geometric Coefficient of Variation|Geometric Mean
656468|NCT01937130|Primary|Area Under the Curve (AUC)|Primary endpoints for AUC_0-8, AUC_0 last, AUC_0-inf on Day 1 and Day 4 for the active treatment arms were analyzed.|28 days|"AUC_0-last: The number of participants analyzed in the 25mg arm was 7 at Day 1 AUC_0-inf: The number of participants analyzed in the 5mg arm was 2 at Day 1 and 0 at Day 4, in the 25mg arm was 5 at Day 1 and 2 at Day 4, in the 50mg arm was 2 at Day 1 and 3 at Day 4.
Values listed as 0 were non-estimable values."||h*ng/mL|Participants|Geometric Coefficient of Variation|Geometric Mean
656469|NCT01937026|Primary|PK: Area Under the Concentration Curve From Time 0 to Infinity [AUC (0-∞)] of Baricitinib||Days 1 and 5: predose of baricitinib, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 and 72 (Day 5 dosing only) hours postdose|All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + probenecid in Period 2) and had PK data to calculate AUC (0-∞) of baricitinib.||nanograms*hour/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
656470|NCT01937026|Primary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of Baricitinib||Days 1 and 5: predose of baricitinib, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 and 72 (Day 5 dosing only) hours postdose|All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + probenecid in Period 2) and had PK data to calculate Cmax of baricitinib.||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
656471|NCT01936896|Other Pre-specified|Safety|We will record the number of participants with all adverse events (cardiac and non-cardiac) over the 3 months, including infusion reactions and drug-related issues.|3 months||||||
656472|NCT01936896|Secondary|Left Ventricular End-systolic Volume Change|We will calculate the interval change between admission and 3 months in left ventricular end-systolic volume, using echocardiography|3 months|Only 5 patients had paired (i.e. baseline and 3 months) echocardiograms for evaluation||mL||Inter-Quartile Range|Median
656473|NCT01936896|Primary|C Reactive Protein (Area Under the Curve)|A single area under the curve (AUC) calculation based upon C-reactive protein (CRP) values drawn at baseline, 3 days, and 14 days.|14 days|||mg/L||Inter-Quartile Range|Median
656474|NCT01936870|Secondary|Change From Baseline in the Overactive Bladder Symptom Score (OABSS)|Overactive Bladder Symptom Score (OABSS) was defined as the sum score (0 to 15) of the following four OAB symptoms: daytime frequency (2 at maximum), nighttime frequency (3 at maximum), urgency (5 at maximum), and urgency incontinence (5 at maximum). Higher score indicates worse symptoms. Mean change from baseline in the OABSS at 12 weeks was presented along with the corresponding standard deviation.|Baseline, 12 Weeks|The effectiveness analysis set comprised of participants from the safety analysis set who had effectiveness evaluation at least once after treatment with fesoterodine fumarate, excluding those with off-label use. Participants with observed change in OABSS were included in table.||Scale||Standard Deviation|Mean
656475|NCT01936870|Secondary|Satisfaction Rate|Satisfaction rate, which was defined as the percentage of participants who were satisfied by fesoterodine fumarate treatment over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Satisfaction scale was assessed by the participants according to the following categories: (1) satisfied, (2) unsatisfied, (3) uncertain, or (4) unconfirmed.|12 Weeks|The effectiveness analysis set comprised of subjects from the safety analysis set who had effectiveness evaluation at least once after treatment with fesoterodine fumarate, excluding those with off-label use.||Percentage||95% Confidence Interval|Number
656476|NCT01936870|Primary|Clinical Efficacy Rate|Clinical efficacy rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Overall effectiveness of fesoterodine fumarate was determined by the investigator based on clinical symptoms and examinations. Clinical effectiveness was assessed according to the following categories: (1) effective, (2) ineffective, or (3) unassessable at week 12 of the treatment.|12 Weeks|The effectiveness analysis set comprised of subjects from the safety analysis set who had effectiveness evaluation at least once after treatment with fesoterodine fumarate, excluding those with off-label use.||Percentage||95% Confidence Interval|Number
656477|NCT01936870|Secondary|Number of Participants With Treatment-Related Adverse Events Among Whose Dose Was Increased From 4 mg to 8 mg|A treatment-related adverse event was any untoward medical occurrence attributed to fesoterodine fumarate in a participant who received fesoterodine fumarate. Relatedness to fesoterodine fumarate was assessed by the investigator.|12 Weeks|The safety analysis set comprised of participants who had satisfied the inclusion criteria of the study, and who had received fesoterodine fumarate at least once.||Participants|||Number
656520|NCT01935180|Secondary|Ease of Terminal Ileum Intubation|"• Proportion of patients, for whom intubation of the terminal ileum with the colonoscope was rated as easy. Intubation could be rated by the endoscopist as easy, slightly difficult, difficult, or unable to intubate."|1 year|||Participants|||Count of Participants
656521|NCT01935180|Secondary|Withdrawal Time|• Time taken for the withdrawal of the colonoscope from the cecum to anus among patients, who did not have any polyps.|1 year|||minutes||Inter-Quartile Range|Median
656478|NCT01936870|Secondary|Number of Participants With Treatment-Related Adverse Events Among Whom Received Concomitant CYP3A4 or CYP2D6 Inhibitors|Cytochrome P450 3A4 (CYP3A4) inhibitors included atazanavir, clarithromycin, indinavir, itraconazole, nelfinavir, ritonavir, saquinavir, and telithromycin. Cytochrome P450 2D6 (CYP2D6) inhibitors included quinidine and paroxetine. A treatment-related adverse event was any untoward medical occurrence attributed to fesoterodine fumarate in a participant who received fesoterodine fumarate. Relatedness to fesoterodine fumarate was assessed by the investigator.|12 Weeks|The safety analysis set comprised of participants who had satisfied the inclusion criteria of the study, and who had received fesoterodine fumarate at least once.||Participants|||Number
656479|NCT01936870|Secondary|Change From Baseline in the Mini-Mental State Examination (MMSE) Score|Mini-Mental State Examination (MMSE) measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. Total score derived from sub-scores; total ranged from 0 to 30, higher score indicates better cognitive state. Mean change from baseline in the MMSE score at 12 weeks was presented along with the corresponding standard deviation.|Baseline, 12 Weeks|The safety analysis set comprised of participants who had satisfied the inclusion criteria of the study, and who had received fesoterodine fumarate at least once. Participants with observed change in MMSE score were included in table.||Scale||Standard Deviation|Mean
656480|NCT01936870|Secondary|Number of Participants With Adverse Events Related to Cognitive Function Disorder|An adverse event was any untoward medical occurrence in a participant who received fesoterodine fumarate without regard to possibility of causal relationship. Adverse events related to cognitive function disorder were identified by broad searches on the Standard MedDRA Queries (SMQ).|12 Weeks|The safety analysis set comprised of participants who had satisfied the inclusion criteria of the study, and who had received fesoterodine fumarate at least once.||Participants|||Number
656481|NCT01936870|Secondary|Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert|A treatment-related adverse event was any untoward medical occurrence attributed to fesoterodine fumarate in a participant who received fesoterodine fumarate. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to fesoterodine fumarate was assessed by the investigator.|12 Week|The safety analysis set comprised of participants who had satisfied the inclusion criteria of the study, and who had received fesoterodine fumarate at least once.||Participants|||Number
656482|NCT01936870|Secondary|Number of Participants With Treatment-Related Serious Adverse Events|A treatment-related adverse event was any untoward medical occurrence attributed to fesoterodine fumarate in a participant who received fesoterodine fumarate. A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to fesoterodine fumarate was assessed by the investigator.|12 Week|The safety analysis set comprised of participants who had satisfied the inclusion criteria of the study, and who had received fesoterodine fumarate at least once.||Participants|||Number
656483|NCT01936870|Primary|Number of Participants With Treatment-Related Adverse Events|A treatment-related adverse event was any untoward medical occurrence attributed to fesoterodine fumarate in a participant who received fesoterodine fumarate. Relatedness to fesoterodine fumarate was assessed by the investigator.|12 Week|The safety analysis set comprised of participants who had satisfied the inclusion criteria of the study, and who had received fesoterodine fumarate at least once.||Participants|||Number
656484|NCT01936844|Secondary|Brachial Artery Vasoreactivity|Change in flow mediated vasodilatation (FMD) of the brachial artery. Brachial artery FMD is calculated as the percentage increase in brachial artery diameter with hyperemia (an increase in the quantity of blood flow to a body part) induced relative to the resting brachial artery diameter. Percentage of brachial artery diameter is measured as FMD diameter/basal diameter. The change is FMD is reported as the % change in FMD from baseline to 14 days.|14 days|Some patients did not undergo assessment at 14 days because they did not show up to their scheduled appointment.||percentage change||Inter-Quartile Range|Median
656485|NCT01936844|Secondary|Left Ventricular Ejection Fraction|Change in left ventricular ejection fraction (LVEF) between admission and 14 day follow up. This value is expressed as absolute change in measured LVEF. For example, if baseline LVEF = 20% and 14 day LVEF = 25%, this would be reported as an absolute change of 5%.|14 days|Some patients did not undergo LVEF assessment at 14 days because they did not show up to their scheduled appointment.||percent LVEF||Inter-Quartile Range|Median
656486|NCT01936844|Primary|C Reactive Protein|"The proportional area-under-the-curve for plasma C reactive protein (CRP) levels measured during the first 3 days of admission. The proportion (y-axis) is calculated at each time-point with respect to the baseline CRP. The resultant y-axis is a unitless proportion. The x-axis is listed as days"|3 days|1 patient in each group withdrew from the study prior to collection of data for the primary endpoint.||days||Inter-Quartile Range|Median
656487|NCT01936662|Secondary|OR to Discharge (Min)|Overall time from arrival in the OR to discharge home (in minutes)|OR to discharge|||Minutes||Standard Deviation|Mean
656488|NCT01936662|Primary|Endoscopist Satisfaction|"Endoscopist was surveyed to determine their satisfaction with each of the airway devices.
Endoscopist used the following satisfaction scale for each patient, regardless of the airway device used:
The airway device did not interfere at all with the ability to perform the scope.
The airway device presented some interference with the scope, but not enough to cause difficulty.
The airway device made it difficult to perform the endoscopy.
The airway device prevented the endoscopy from being performed."|2 hours|||units on a scale||Standard Deviation|Median
656522|NCT01935180|Secondary|Quality of Bowel Preparation|Proportion of patients with a bowel preparation that was rated as good or excellent (four point scale that distinguishes the bowel prep as poor, fair, good or excellent).|1 year|||Participants|||Count of Participants
656523|NCT01935180|Secondary|Advanced Adenoma Detection Rate|Proportion of patients with advanced adenomas|1 year|||Participants|||Count of Participants
656524|NCT01935180|Secondary|Adenoma Detection Rate|• Adenoma detection rate (ADR), % of patients with at least 1 adenoma|1 year|||Participants|||Count of Participants
656525|NCT01935180|Primary|Mean Number of Adenomas|Mean number of adenomas per patient in each group.|1 year|||adenoma per patient||Standard Deviation|Mean
656489|NCT01936649|Secondary|To Assess the Test-retest Reproducibility of Iobenguane I 123 Injection Myocardial Uptake on Planar Imaging at 15 Minutes Following Administration of AdreView (Iobenguane I 123 Injection)|Measurements of H/M ratio and the extent of difference between H/M measurements following AdreView administration and 15 minutes delayed planar imaging on 2 separate days within an interval of 5 to 14 days, was used to assess the test-retest reproducibility. Data from test-retest study was used to estimate the normal ranges for variation in quantitation of myocardial tracer uptake using AdreView. H/M ratios were calculated by 3 technologists and average of 3 technologists was calculated based on non-missing technologists reviewing results. All non-missing technologist evaluations were averaged per participant.|15 minutes post administration of 2 dosing within an interval of 5 to 14 days|Efficacy population that included all participants who underwent 2 administrations of AdreView; had at least an interpretable planar image acquisition at 15 minutes post-injection after each AdreView administration. Here, 'n' signifies number of participants analyzed by the technologist.||Ratio||Standard Deviation|Mean
656490|NCT01936649|Primary|To Assess Test-retest Reproducibility of Iobenguane I 123 Injection Myocardial Uptake in Heart Failure (HF) Participants on Planar Imaging at 3 Hours 50 Minutes Following I.V. Injection of AdreView (Iobenguane I 123 Injection)|Participants underwent 2 AdreView (Iobenguane I 123 Injection) exams on the same gamma camera within 5 to 14 days, with the requirement that there was no change in the clinical condition of the participant or in the imaging equipment between the 2 procedures. Each imaging study was processed and read independently by 3 technologists. Mean heart/mediastinum (H/M) ratio difference (with 95% confidence interval [CI]) was used as the measure of test stability.|3 Hours 50 Minutes post administration of 2 dosing within an interval of 5 to 14 days|Efficacy population that included all participants who underwent 2 administrations of AdreView (Iobenguane I 123 Injection); had at least an interpretable planar image acquisition at 3 hours 50 minutes post-injection after each AdreView administration. Here, 'n' signifies number of participants analyzed by the technologist.||Ratio||Standard Deviation|Mean
656491|NCT01936623|Other Pre-specified|Number of Subjects Positive on Hair Testing for Marijuana, Cocaine, Amphetamines, or Opioids|Radioimmunoassay Testing (RIA) was conducted|6-month follow-up|Hair samples were missing due to refusal, insufficient quantity, and missing follow-up interview.||Participants|||Count of Participants
656492|NCT01936623|Other Pre-specified|Number of Subjects Testing Positive on Hair Testing for Marijuana, Cocaine, Amphetamines, or Opioids.|Radioimmunoassay (RIA) Tests were used.|3-month|Hair samples were missing due to refusal, insufficient quantity, and missing follow-up interview.||Participants|||Count of Participants
656493|NCT01936623|Secondary|Alcohol, Smoking, and Substance Involvement Screening Tests (ASSIST) Global Continuum of Illicit Drug Risk Score|The ASSIST Global Continuum of Illicit Drug Risk Score ranges from 0 to 308, with higher scores indicating greater risk.|6-month follow-up|||units on a scale||Standard Error|Least Squares Mean
656494|NCT01936623|Primary|Alcohol, Smoking, and Substance Involvement Screening Tests (ASSIST) Global Continuum of Illicit Drug Risk Score|The ASSIST Global Continuum of Illicit Drug Risk Score ranges from 0 to 308, with higher scores indicating greater risk.|3 month follow-up|||units on a scale||Standard Error|Least Squares Mean
656495|NCT01936467|Secondary|Diagnostic Accuracy of EUS-FNA|The proportion of subjects without the disease with negative EUS-FNA in total of subjects without the disease|6 months|||percent accurate|||Number
656496|NCT01936467|Secondary|Acquisition of Core Tissue|The rate of acquiring core tissue of the pancreatic mass through EUS-FNA|immediate|||participants|||Number
656497|NCT01936467|Secondary|First Pass Diagnostic Rate|The rate of aquiring diagnostic pancreatic mass tissue with first FNA pass|immediate|||participants|||Number
656498|NCT01936467|Primary|Sensitivity of EUS-FNA|Comparison of EUS-FNA sensitivity using Capillary technique versus Standard technique for pancreatic solid lesions|6 months|The discrepancy between the number of analyzed patients and the number of patients in the Participant Flow section is due to the fact that calculation of sensitivity was done based on the Per Protocol analysis.||percentage of positive gold standard|||Number
656499|NCT01936467|Primary|Sensitivity of EUS-FNA With StandardTechnique|Sensitivity of the EUS-FNA with Capillary technique|6 months|The discrepancy between the number of analyzed patients and the number of patients in the Participant Flow section is due to the fact that calculation of sensitivity was done based on the Per Protocol analysis.||Participants|||Number
656500|NCT01936467|Primary|Sensitivity of EUS-FNA With Capillary Technique|Sensitivity of the EUS-FNA with Capillary technique|6 months|The discrepancy between the number of analyzed patients and the number of patients in the Participant Flow section is due to the fact that calculation of sensitivity was done based on the Per Protocol analysis.||participants|||Number
656501|NCT01936467|Primary|Diagnostic Yield of Standard Technique|Diagnostic yield is defined as percentage of specimens in which diagnostic material is obtained.|up to 6 months|||percentage of specimen|||Number
656502|NCT01936467|Primary|Diagnostic Yield of Capillary Technique|Diagnostic yield is defined as percentage of specimens in which diagnostic material is obtained.|up to 6 months|||percentage of specimen|||Number
656503|NCT01936389|Primary|Evaluate the Ocular Hypotensive Efficacy of Rho Kinase Inhibitor (AR-12286 0.5% and 0.7%)|Goldmann Aplanation Tonometry (IOP mmHg) will be used to measure the ocular hypotensive efficacy.|6 months|||mmHg||Standard Deviation|Mean
656504|NCT01936363|Secondary|Molecular Alterations in MAPK and/or PI3K Signaling Pathway Components/Modulators in Tumor Tissue and Blood||Screening visit (day -28 to 1)|As per changed in planned analysis the outcome measure related to pharmacodynamics parameters was not assessed.|||||
656505|NCT01936363|Secondary|Area Under the Curve (AUC) After Dose of Pimasertib and SAR245409||Pre-dose Hour 0.5, 1.5, 4.5 8 post dose on Day 15, 29, 43|As per changed in planned analysis the outcome measure related to pharmacokinetic parameters was not assessed.|||||
656506|NCT01936363|Secondary|Maximum Plasma Concentration (Cmax) After Dose of Pimasertib and SAR245409||Pre-dose Hour 0.5, 1.5, 4.5 8 post dose on Day 15, 29, 43|As per changed in planned analysis the outcome measure related to pharmacokinetic parameters was not assessed.|||||
656526|NCT01934894|Secondary|CNS Progression Free Survival|Evaluate the three and six-month CNS progression free survival measured from date of first protocol treatment until tumor progression or death.|every 6 weeks thru cycle 8, then every 9 weeks until treatment discontinuation, projected 1 year|No data was collected for this outcome measure.|||||
657596|NCT01919229|Secondary|Change in ECG Morphology||Baseline, Day 14|Since the study was terminated, no efficacy data was obtained.|||||
656507|NCT01936363|Secondary|Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), TEAEs Leading to Discontinuation of Treatment and Death|TEAEs, SAEs and AEs was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.0. An adverse events was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to data cut-off that were absent before treatment or that worsened relative to pretreatment state.|First dose of study drug up to Data Cut-off (19 May 2015)|SAF analysis set included all subjects who received at least one dose of any trial treatment.||subjects|||Number
656508|NCT01936363|Secondary|Health Related Quality of Life (HrQoL) Assessed Using European Organization for Research and Treatment of Cancer (EORTC) Ovarian-Specific Module Quality of Life Questionnaire Ovarian Cancer Module (QLQ-OV28)|EORTC QLQ-OV28 assesses disease and treatment-related symptoms of ovarian cancer. The 28-item module comprises of 6 symptom scales (abdominal/gastrointestinal symptoms, peripheral neuropathy, other chemotherapy side-effects, hormonal symptoms, body image, attitude to disease and treatment), and sexual functioning. All of the scales and the individual single-items ranged in score from 0 to 100. Higher scores indicate a better quality of life.|Baseline up to disease progression or withdrawal, assessed up to Data Cut-off (19 May 2015)|Data was not collected for this outcome because as per Protocol Amendment 4 (dated 13 March 2015), the collection of patient-reported health-related quality of life outcomes was discontinued.|||||
656509|NCT01936363|Secondary|Health Related Quality of Life (HrQoL) Assessed Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30)|EORTC QLQ-C30 is a 30-item questionnaire comprising of five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea/vomiting), six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial impact), and a global quality of life (QoL) scale summarized from two 7-point scales (overall QoL and overall general health). Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and the individual single-items ranged in score from 0 to 100. A high scale score represents a higher response level. High score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.|Baseline up to disease progression or withdrawal, assessed up to Data Cut-off (19 May 2015)|Data was not collected for this outcome because as per Protocol Amendment 4 (dated 13 March 2015), the collection of patient-reported health-related quality of life outcomes was discontinued.|||||
656510|NCT01936363|Secondary|Overall Survival|Overall survival (OS) was defined as the time (in months) from randomization to death. Data has been presented in terms of number subjects who died and number of censored subjects.|Time from randomization until death, assessed up to Data Cut-off (19 May 2015)|ITT analysis set included all subjects who had been randomized.||subjects|||Number
656511|NCT01936363|Secondary|Percentage of Subjects With Disease Control|Disease control as per RECIST v.1.1 was defined as the proportion of subjects with stable disease (SD), for at least 16 weeks, PR or CR according to RECIST v1.1 criteria. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: At least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters). CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.|Randomization until disease progression or death assessed every 8 weeks up to week 32, and thereafter every 12 weeks up to Data Cut-off (19 May 2015)|ITT analysis set included all subjects who had been randomized.||percentage of subjects||95% Confidence Interval|Number
656512|NCT01936363|Secondary|Progression-Free Survival|PFS defined as time from randomization to first documentation of objective tumor progression.CR:Disappearance of all target lesions.Any pathological lymph nodes(whether target or non-target)must have reduction in short axis to<10 mm.PR:At least 30% decrease in sum of diameters of target lesions,taking as reference baseline sum diameters.PD:At least a 20% increase in sum of diameters of target lesions,taking as reference smallest sum on study.In addition to relative increase of 20%,the sum also demonstrate absolute increase of at least 5 mm.SD:Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD,taking as reference smallest sum diameters while on study. PFS calculated as(Months)=first event date minus randomization or first dose date plus 1.Median PFS was computed using Kaplan-Meier estimates (product-limit estimates) and was presented with 95% confidence interval.The confidence intervals for median was calculated according to Brookmeyer and Crowley.|Time from randomization until first observation of progressive disease or death, assessed up to Data Cut-off (19 May 2015)|ITT analysis set included all subjects who had been randomized.||months||95% Confidence Interval|Median
656513|NCT01936363|Primary|Objective Tumor Response|Objective tumor response was defined as the presence of at least one Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm). Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|From randomization until disease progression or death assessed every 8 weeks up to week 32, and thereafter every 12 weeks up to Data Cut-off (19 May 2015)|ITT analysis set included all subjects who had been randomized.||percentage of subjects||95% Confidence Interval|Number
656514|NCT01936181|Secondary|Disease Activity Score Based on a 28 Joint Count (DAS28)||Week 30, Week 54, Week 78||||||
656515|NCT01936181|Secondary|American College of Rheumatology 50% Response Criteria (ACR50)||Week 30, Week 54, Week 78||||||
656516|NCT01936181|Secondary|ACR20||Week 54, Week 78|||percentage of participants|||Number
656517|NCT01936181|Primary|American College of Rheumatology 20% Response Criteria (ACR20)||Week 30|||percentage of participants|||Number
656518|NCT01935622|Primary|Peak Aerobic Exercise Capacity|Interval change in peak VO2 measured at cardiopulmonary test|14 days|||||Inter-Quartile Range|Median
656527|NCT01934894|Secondary|Extra-Cranial Objective Response|The number of participants having Complete and Partial Responses (CR+PR) of extra-cranial lesions assessed per RECIST v1.1 Criteria. CR=disappearance of all target and non-target lesions; PR=at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter AND an absolute decrease of at least 5mm in at least one target lesion.|every 6 weeks for 8 cycles, then every 9 weeks until treatment discontinuation, up to 1 year|||Participants|||Count of Participants
656528|NCT01934894|Secondary|CNS Clinical Benefit Response|The number of patients with Complete Response, Partial Response or Stable Disease extending beyond 6 months (CR+PR+SD ≥ 6 months), determined by RECIST v1.1. CR=disappearance of all target and non-target lesions; PR=at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter AND an absolute decrease of at least 5mm in at least one target lesion; SD=Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum of the longest diameter since the treatment started.|every 6 weeks thru cycle 8, and every 3 cycles thereafter until treatment discontinuation, projected 1 year|||Participants|||Count of Participants
656529|NCT01934894|Primary|Number of Participants Who Experience Dose-Limiting Toxicities (DLTs) as a Measure of Safety|During the safety lead-in, a standard 3+3 dose escalation design is used to determine the maximum tolerated dose (MTD) of cabazitaxel with lapatinib. The MTD would be determined by the highest dose at which ≤1 of 6 patients experiences a dose-limiting toxicity (DLT) during 1 cycle (21 days) of therapy. If 2 of 6 patients within a dose level experiences a DLT, that dose level would be defined as exceeding the MTD and the previous dose level would be evaluated. DLTs are assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0.|weekly for 3 weeks|||Participants|||Count of Participants
656530|NCT01934894|Primary|Maximum Tolerated Dose of Cabazitaxel With Lapatinib|The maximum tolerated dose (MTD) of cabazitaxel and lapatinib will be determined as the highest dose at which ≤1 of 6 patients experiences a dose-limiting toxicity (DLT) assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0. A listing of DLTs are reported in the subsequent Primary Outcome Measure.|weekly for 3 weeks|Includes all treated participants, either at Dose Level 1 or Dose Level 2||mg/m^2 of cabazitaxel + lapatinib|||Number
656531|NCT01934894|Primary|CNS Objective Response|The number of patients with Complete and Partial Response (CR+PR) of CNS lesions assessed per modified RECIST Criteria for Evaluation of Intracranial Disease. CR=disappearance of all target and non-target lesions; PR=at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter AND an absolute decrease of at least 5mm in at least one target lesion.|every 6 weeks thru cycle 8, then every 9 weeks until treatment discontinuation, projected 1 year|Includes all treated participants||Participants|||Count of Participants
656532|NCT01934790|Other Pre-specified|SSE-free Survival|The SSE-FS is the time (days) from the treatment start date to the first SSE on or following the start date or death, whichever occurred first. Participants not experiencing death or an SSE at the database cutoff date for primary completion were censored at the last assessment for SSEs.|Up to 2.5 years|Safety Analysis Set (SAF): all participants who received at least one dose of study drug.||Months||95% Confidence Interval|Median
656533|NCT01934790|Other Pre-specified|Time to First Symptomatic Skeletal Event (SSE)|Time to first symptomatic skeletal event (SSE) is the time (days) from the treatment start date to the first SSE on or following the start date. Participantsnot experiencing an SSE at the database cutoff date for primary completion, whether or not surviving, were censored at the last assessment for SSEs.|Up to 2.5 years|Safety Analysis Set (SAF): all participants who received at least one dose of study drug.||Months||95% Confidence Interval|Median
656534|NCT01934790|Other Pre-specified|Time to Pain Progression|Pain progression was defined in participants evaluable for pain progression at baseline, i.e., participants with a WPS of ≤ 7 at the baseline assessment. Pain assessment occurred daily for 1 week, beginning 1 week prior to each visit and including the day of the visit. An evaluable pain assessment interval required completion of a minimum of 4 out of 7 daily questions. Pain progression was defined as the occurrence of either a pain increase or an increase in pain management with respect to baseline, whichever occurred first.|Up to 2.5 years|Safety Analysis Set (SAF): all participants who received at least one dose of study drug.||Months||95% Confidence Interval|Median
656535|NCT01934790|Other Pre-specified|Percentage of Participants With Pain Improvement|Pain improvement was defined in evaluable participants (participants with worst pain score [WPS] of 4 at baseline) as a 30% and 2-point decrease in WPS over 2 consecutive measurements conducted at least 4 weeks apart, without an increase in pain management. Pain improvement rate was the number of participants with pain improvement, divided by the total number of evaluable participants WPS was the mean of the WPS in the last 24 hours from the preceding 7 days.|Up to 2.5 years|Safety Analysis Set (SAF): all participants who received at least one dose of study drug.||Percentage of participants||95% Confidence Interval|Number
656536|NCT01934790|Other Pre-specified|Overall Survival|Overall survival (OS) was defined as the time (days) from the treatment start date to the date of death due to any cause. For participants who were still alive or who were lost to follow-up as of the database cutoff date for the primary completion, OS was censored at the last known alive date on or prior to the database cutoff date.|Up to 2.5 years|Safety Analysis Set (SAF): all participants who received at least one dose of study drug.||Months||95% Confidence Interval|Median
656537|NCT01934790|Other Pre-specified|Time to PSA Progression|Prostate specific antigen progression was defined as a ≥ 25% increase above the nadir (lowest baseline or post-baseline) value, and an increase in absolute value of ≥ 2 ng/mL above nadir. The time to PSA progression was defined as the time (days) from the treatment start date to the date of first PSA progression. Participants without PSA progression as of the database cutoff for primary completion, whether or not surviving, were censored at the last PSA laboratory assessment.|Up to 2.5 years|Safety Analysis Set (SAF): all participants who received at least one dose of study drug.||Months||95% Confidence Interval|Median
656552|NCT01934582|Secondary|To Assess 6-minute Walk Distance for Both Groups (BID and TID) 3 to 6 Hours Post-morning Dose.|The 6-minute walk test (6MWT) was conducted at PK Visits 1 and 2, and was performed between hours 3 to 6 post-morning dose to correlate with the predicted peak plasma concentration of oral treprostinil.|The 6MWT was conducted during BID dosing PK collection (up to 14 days prior to transitioning to TID dosing regimen [PK Visit 1]) and during TID dosing PK collection (up to 35 days after transitioning to TID dosing regimen [PK Visit 2]).|||Meters||Full Range|Mean
656538|NCT01934790|Other Pre-specified|Percentage of Participants With Prostate Specific Antigen (PSA) Response|Prostate specific antigen (PSA) response was defined as a ≥ 30% reduction of blood PSA level compared with the baseline value, confirmed by a second subsequent PSA value with a ≥ 30% reduction from baseline approximately 4 or more weeks later. Prostate specific antigen response rate was defined as the number of participants with PSA response divided by the total number of participants evaluable for PSA response.|Up to 2.5 years|Safety Analysis Set (SAF): all participants who received at least one dose of study drug.||Percentage of participants||95% Confidence Interval|Number
656539|NCT01934790|Other Pre-specified|Percent Change in Total ALP||Baseline and Week 12, Week 24|Safety Analysis Set (SAF): all participants who received at least one dose of study drug.||Percent change||Standard Deviation|Mean
656540|NCT01934790|Other Pre-specified|Time to Total ALP Progression|Total ALP progression was defined as a ≥ 25% increase above the nadir (lowest baseline or post-baseline) value to at least 1.5 x ULN (upper limit of normal). The time to total ALP progression was defined as the time (days) from the treatment start date to the date of first total ALP progression. Participants not experiencing ALP progression at the database cutoff date, whether or not surviving, were censored at the last ALP laboratory assessment.|Up to 2.5 years|Safety Analysis Set (SAF): all participants who received at least one dose of study drug.||Months||95% Confidence Interval|Median
656541|NCT01934790|Other Pre-specified|Percentage of Participants With Total Alkaline Phosphatase (ALP) Response|Total alkaline phosphatase (ALP) response was defined as ≥ 30% reduction of the blood total ALP level compared with the baseline values. Total ALP response rate was defined as the number of participants with total ALP response divided by the total number of participants evaluable for total ALP response.|Up to 2.5 years|Safety Analysis Set (SAF): all participants who received at least one dose of study drug.||Percentage of participants||95% Confidence Interval|Number
656542|NCT01934790|Other Pre-specified|Time to Radiological Bone Progression|Time to radiological bone progression was defined as the time (days) from the treatment start date to the date of radiological bone progression (according to the adapted PCWG2 [Prostate Cancer Clinical Trials Working Group 2] criteria), as documented by the investigator. Participants not experiencing radiological bone progression at the database cutoff for primary completion were censored at the last radiological bone progression assessment.|Up to 2.5 years|Safety Analysis Set (SAF): all participants who received at least one dose of study drug.||Months||95% Confidence Interval|Median
656543|NCT01934790|Other Pre-specified|Radiological Progression Free Survival (rPFS)|Radiological progression-free survival (rPFS) was defined as the time from the treatment start date to the date of radiological disease progression or death from any cause (if death occurred before such progression), as documented by the investigator. Participants not experiencing death or radiological disease progression at the database cutoff for primary completion were censored at the last radiological disease progression assessment.|Up to 2.5 years|Safety Analysis Set (SAF): all participants who received at least one dose of study drug.||Months||95% Confidence Interval|Median
656544|NCT01934790|Primary|Number of Participants Who Discontinued Radium-223 Dichloride Treatment Due to Treatment Emergent AEs or Death|An adverse event (AE) is any untoward medical occurrence (i.e., any unfavorable and unintended sign [including abnormal laboratory findings], symptom, or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. A treatment-emergent adverse events (TEAE) is defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of radium-223 dichloride.|Up to 2.5 years|Safety Analysis Set (SAF): all participants who received at least one dose of study drug.||Participants|||Number
656545|NCT01934790|Primary|Number of Participants With High/Low Abnormalities in Biochemistry Variables at Any Visit After Treatment Start||Up to 2.5 years|Safety Analysis Set (SAF): all participants who received at least one dose of study drug.||Participants|||Number
656546|NCT01934790|Primary|Number of Participants With High/Low Abnormalities in Hematology Variables at Any Visit After Treatment Start||Up to 2.5 years|Safety Analysis Set (SAF): all participants who received at least one dose of study drug.||Participants|||Number
656547|NCT01934790|Primary|Number of Participants With Radium-223 Dichloride-related SAEs in the Active Follow-up Period|Treatment-related SAE is any SAE that, according to the investigator’s causality assessment, is possibly or probably related to treatment with radium-223 dichloride.|Up to 2 years after last treatment||09/2017||||
656548|NCT01934790|Primary|Number of Participants With Radium-223 Dichloride-related AEs in the Active Follow-up Period|An adverse event (AE) is any untoward medical occurrence (i.e., any unfavorable and unintended sign [including abnormal laboratory findings], symptom, or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study.|Up to 2 years after last treatment||09/2017||||
656549|NCT01934790|Primary|Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)|TESAE occurred after the start of radium-223 dichloride treatment until 30 days after the last dose and results in death; is life-threatening; requires inpatient hospitalization or prolongs existing hospitalization; results in persistent or significant disability or incapacity; is a congenital anomaly / birth defect; is another medically important serious event as judged by the investigator; or is an occurrence of leukemia, myelodysplastic syndrome, aplastic anemia, myelofibrosis, and primary bone cancer or any other new primary malignancy, such as acute myeloid leukemia.|Up to 2.5 years|Safety Analysis Set (SAF): all participants who received at least one dose of study drug.||Participants|||Number
656550|NCT01934790|Primary|Number of Participants With Treatment-emergent Adverse Events (AEs)|An adverse event (AE) is any untoward medical occurrence (i.e., any unfavorable and unintended sign [including abnormal laboratory findings], symptom, or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. A treatment-emergent adverse events (TEAE) is defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of radium-223 dichloride.|Up to 2.5 years|Safety Analysis Set (SAF): all participants who received at least one dose of study drug.||Participants|||Number
656551|NCT01934582|Secondary|To Compare the Adverse Event (AE) Profile of BID Versus TID Dosing.|AE diaries including 8 therapy-specific terms were collected during both BID and TID dosing to allow for comparison of events from both regimens. The therapy-specific events included: diarrhea, extremity pain, flushing, headache, hypotension, jaw pain, nausea, and vomiting.|The AEs were recorded for up to 50 days.|||percentage of subjects|||Number
656553|NCT01934582|Primary|To Assess the Pharmacokinetics (AUClast) in Subjects During Twice Daily (BID) Dosing (up to 14 Days Prior to Transitioning to Three Times Daily [TID] Dosing Regimen at PK Visit 1) and up to 35 Days After Transitioning to TID Dosing (at PK Visit 2).|The PK sampling occurred over a 12-hour period in subjects during BID dosing (PK Visit 1) and during TID dosing (PK Visit 2). Prior to each PK sampling day, subjects must have been receiving a stable dose for at least 5 days.|Up to 14 days prior to transitioning to TID dosing regimen (PK Visit 1) and up to 35 days after transitioning to TID dosing regiment (PK Visit 2)|||h*ng/mL||Full Range|Mean
656554|NCT01934582|Primary|To Assess the Pharmacokinetics (Cmax, Cmin) in Subjects During Twice Daily (BID) Dosing (up to 14 Days Prior to Transitioning to Three Times Daily [TID] Dosing Regimen at PK Visit 1) and up to 35|The PK sampling occurred over a 12-hour period in subjects during BID dosing (PK Visit 1) and during TID dosing (PK Visit 2). Prior to each PK sampling day, subjects must have been receiving a stable dose for at least 5 days.|Up to 14 days prior to transitioning to TID dosing regimen (PK Visit 1) and up to 35 days after transitioning to TID dosing regiment (PK Visit 2)|||ng/mL||Full Range|Mean
656555|NCT01934582|Primary|To Assess the Pharmacokinetics (Mean AM Dose) in Subjects During Twice Daily (BID) Dosing (up to 14 Days Prior to Transitioning to Three Times Daily [TID] Dosing Regimen at PK Visit 1) and up to 35 Days After Transitioning to TID Dosing (at PK Visit 2).|The PK sampling occurred over a 12-hour period in subjects during BID dosing (PK Visit 1) and during TID dosing (PK Visit 2). Prior to each PK sampling day, subjects must have been receiving a stable dose for at least 5 days.|Up to 14 days prior to transitioning to TID dosing regimen (PK Visit 1) and up to 35 days after transitioning to TID dosing regiment (PK Visit 2)|||mg||Full Range|Mean
656556|NCT01934517|Primary|Overjet|Overjet: measured as the greatest horizontal distance from the labial surface of the lower central incisor to the most inferior point at the mesiodistal center of the upper central incisor|one year|||mm||95% Confidence Interval|Mean
656557|NCT01934504|Secondary|Immunosuppression Associated Signature|"Definition of an immune signature associated with maintenance immunosuppression.
Due to early study termination, data was not available to evaluate this endpoint."|Baseline to 8 Weeks Post-Immunosuppression Withdrawal|No analyses were performed due to slow enrollment and early study closure.|||||
656558|NCT01934504|Secondary|Tolerance Signature Versus Clinical Status|"Correlation of possible changes in the tolerance signature with changes in clinical status.
Due to early study termination, data was not available to evaluate this endpoint."|Baseline to Week 26|No analyses were performed due to slow enrollment and early study closure.|||||
656559|NCT01934504|Secondary|Tolerance Signature Stability|"Measurement of the stability of a tolerance immune signature in patients with AAV over time.
Due to early study termination, data was not available to evaluate this endpoint."|Baseline to Week 26|No analyses were performed due to slow enrollment and early study closure.|||||
656560|NCT01934504|Primary|Tolerance Biomarker Identification|"Identification of biomarkers associated with clinical tolerance in patients with ANCA-associated vasculitis by comparative immunophenotyping of individual leukocyte subsets from tolerant and non-tolerant patients with AAV.
Due to early study termination, data was not available to evaluate this endpoint."|Difference from baseline to week 26|No analyses were performed due to slow enrollment and early study closure.|||||
656561|NCT01934231|Secondary|Number of Participants (Par.) With the Specified Bacteriological (Bact.) Outcome Per Participant at EOT (Day 8)|The investigator used the sample collected at the start of study treatment (trt) to isolate and identify the pathogenic bacteria. The sample collected at the EOT was used to evaluate the bact. response to the investigational product of each par. using the following classification: Bact. eradication (erad.), presumed bact. erad. and colonization were categorized as erad. Bact. persistence (pers.), presumed bact. pers. and superinfection were categorized as pers. Bact. erad. elimination of the pathogen (path.) after trt; presumed bact. erad.-resolution of signs/symptoms (s/s) after trt; colonization-resolution of s/s but initial path. still recovered from sample; bact. pers.-no improvement in s/s and initial path. was recovered from sample; presumed bact. pers.-no improvement in s/s and isolation of initial path. was impossible/not performed; superinfection-initial path. was eradicated but a new path. was recovered; unable to determine-bact. test could not be performed.|Day 8|Bacteriology PP Population: all participants in the PP Population, excluding the participants who were classified as “Unable to determine” for the bacteriological outcome and who had no identified pathogen at Day 1||Participants|||Number
656562|NCT01934231|Secondary|Number of Participants (Par.) With the Specified Bacteriological (Bact.) Outcome Per Pathogen (Path.) at the End of Treatment (EOT) at Day 8|"The investigator used the sample collected at the start of study treatment (trt) to isolate and identify the pathogenic bacteria. The sample collected at the EOT was used to evaluate the bact. response to the investigational product of each path. If the same pathogen was not detected at the EOT, this pathogen was classified as eradication (E). If the same pathogen was detected at the EOT, this pathogen was classified as persistence (P)."|Day 8|Bacteriology PP Population: all participants in the PP Population, excluding the participants who were classified as “Unable to determine” for the bacteriological outcome and who had no identified pathogen at Day 1||Participants|||Number
656563|NCT01934231|Secondary|Number of Participants With the Indicated Severity of Symptoms and Nasal Cavity Findings at Day 4, Day 8, and Day 15|The investigator (or sub-investigator) categorized the severity of symptoms such as rhinorrhoea and bad mood/productive cough as none, mild/small amount (M/SA), or moderate or severe (M or S). For the nasal cavity finding of nasal/postnasal discharge (N/PD) the categozation was serous [containing serum]), mucopurulent (MU/SA [containing both mucus and pus]), and moderate or larger amount (M/LA). In cases in which both sides of the nasal cavity were affected and there was no difference in severity between the sides, the right-side results were recorded. If there was a difference in severity, the more severe-side results were recorded.|Baseline (BL), Day 4, Day 8, and Day 15|PP Population||Participants|||Number
656575|NCT01933880|Secondary|Number of Participants Compliant With Treatment|Number of Participants who are Compliant with Treatment will be accessed. Less than 80 percent and more than 120 percent compliance signifies bad compliance, 80 to 120 percent compliance signifies good compliance . The compliance was calculated by the percentage of dose (actual dose multiplied by 100/theoretical dose).The theoretical dose means the dose prescribed by the Investigator.|End of Week 12|"FAS population for OROS-MPH Group. Here N signifies participants who were evaluable for this outcome measure. Data for Normal group was not analyzed for IOWA Conners scale since as per the planned analysis normal participants were only analyzed for the memory effect in cognitive function test."||participants|||Number
656564|NCT01934231|Secondary|"Number of Participants With a Clinical Outcome of Cure at Both the End of Treatment and Test of Cure (EOT and TOC: Day 8 and Day 15)"|"Clinical assessment of acute bacterial rhinosinusitis was performed by the investigator (or subinvestigator) at the EOT (Day 8) and TOC (Day 15) on the basis of the following criteria: Cure is defined as sufficient resolution or improvement of the signs and symptoms such that no additional antibiotic therapy is needed. Failure is defined as no change or deterioration of the signs and symptoms or as additional antibiotic therapy being needed. The outcome was unable to be determined if no information was available regarding the signs and symptoms or, despite improvement of the signs and symptoms, the use of a non-study antibiotic was administered, indicating that there was a protocol deviation. In order to be categorized as cure, participants had to meet the criteria for cure at both Day 8 and Day 15."|Day 8 and Day 15|PP Population||Participants|||Number
656565|NCT01934231|Secondary|"Number of Participants With a Clinical Outcome of Cure at the End of Treatment (EOT: Day 8)"|"Clinical assessment of acute bacterial rhinosinusitis was performed by the investigator (or subinvestigator) at the EOT (Day 8) on the basis of the following criteria: Cure is defined as sufficient resolution or improvement of the signs and symptoms such that no additional antibiotic therapy is needed. Failure is defined as no change or deterioration of the signs and symptoms or as additional antibiotic therapy being needed. The outcome was unable to be determined if no information was available regarding the signs and symptoms or, despite improvement of the signs and symptoms, the use of a non-study antibiotic was administered, indicating that there was a protocol deviation."|Day 8|PP Population||Participants|||Number
656566|NCT01934231|Primary|"Number of Participants With a Clinical Outcome of Cure at Test of Cure (TOC: Day 15)"|"Clinical assessment of acute bacterial rhinosinusitis was performed by the investigator (or subinvestigator) at TOC (Day 15) on the basis of the following criteria: Cure is defined as sufficient resolution or improvement of the signs and symptoms such that no additional antibiotic therapy is needed. Failure is defined as no change or deterioration of the signs and symptoms or as additional antibiotic therapy being needed. The outcome was unable to be determined if no information was available regarding the signs and symptoms or, despite improvement of the signs and symptoms, the use of a non-study antibiotic was administered, indicating that there was a protocol deviation."|Day 15|Per Protocol (PP) Population: all participants randomized to treatment who received the study drug for at least the first 3 days of study treatment in the Treatment Period and had evaluable data on both Day 8 and Day 15 with treatment compliance between 80% and 100% and no major protocol deviations||Participants|||Number
656567|NCT01934218|Post-Hoc|Change From Baseline in Visual Analogue Scores (VAS) Following 50-foot Walk Test at Week 26|Observed VAS of 100 mm; 0 mm meaning no pain; 100 mm meaning extreme pain following 50-foot walk test. Change in score from baseline to week 26 was calculated as baseline minus week 26.|Baseline and Week 26|The post-hoc analysis plan pre-specified that only the change at week 26 in the Gel-One arm is intended to be analyzed.||mm||95% Confidence Interval|Mean
656568|NCT01934218|Primary|Change From Baseline in Visual Analogue Scores (VAS) Following 50-foot Walk Test Through Week 26|Observed VAS of 100 mm; 0 mm meaning no pain; 100 mm meaning extreme pain following 50-foot walk test. Change in score from baseline through week 26 was estimated using a longitudinal model.|Baseline up to Week26|||mm||95% Confidence Interval|Mean
656569|NCT01933932|Secondary|Time to Symptom Progression Using Average Symptom Burden Index (ASBI) of the Lung Cancer Symptom Scale (LCSS)|Time to symptom progression will be defined as the time from randomization until the date of first clinically meaningful symptom deterioration (defined as an increase in the ASBI from baseline ≥10), or death (by any cause). LCSS-Lung Cancer Symptom Scale; ASBI-Average symptom burden index.|Measured from date of randomisation until 30 days post treatment discontinuation or 30 days post progression (if study treatment is discontinued before progression). Estimated final completion : approximately 3 years after first subject in (FSI)|Full analysis set (FAS) patients who have a baseline ASBI score <= 90||Months||Inter-Quartile Range|Median
656570|NCT01933932|Secondary|Symptom Improvement Rate Using Average Symptom Burden Index (ASBI) of the Lung Cancer Symptom Scale (LCSS)|The symptom improvement rate will be defined as the number (%) of patients with two consecutive assessments at least 18 days apart (ie 21 days allowing a visit window of 3 days) which showed a clinically meaningful improvement in symptoms from baseline (defined as a decrease in the ASBI from baseline ≥10). LCSS-Lung Cancer Symptom Scale; ASBI-Average symptom burden index.|Measured from date of randomisation until 30 days post treatment discontinuation or 30 days post progression (if study treatment is discontinued before progression). Estimated final completion : approximately 3 years after first subject in (FSI)|Full analysis set (FAS) patients who have a baseline ASBI score >= 10||Participants|||Count of Participants
656571|NCT01933932|Secondary|Duration of Response (DoR)|Duration of response is defined as the time from the date of first documented response until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression)|Measured at baseline until the date of first documented objective disease progression. Estimated final completion : approximately 3 years after first subject in (FSI)|Full analysis set (FAS) population comprised of all randomised patients.||Days||95% Confidence Interval|Median
656572|NCT01933932|Secondary|Objective Response Rate (ORR)|ORR is defined as the number (%) of subjects with at least one overall visit response of complete response (CR) or partial response (PR). Per RECIST v1.1 for target lesions and assessed by CT/MRI: CR - disappearance of all target lesions; PR - >=30% decrease in the sum of the longest diameter of target lesion. (Non-target lesion and new lesion results are also taken into account for the overall visit result)|Measured at baseline until the date of first documented objective disease progression. Estimated final completion : approximately 3 years after first subject in (FSI)|Full analysis set (FAS) population comprised of all randomised patients.||Participants|||Count of Participants
656573|NCT01933932|Secondary|Overall Survival (OS)|Overall Survival is defined as the time from the date of randomisation until death due to any cause.|Measured at baseline until date of death due to any cause. Estimated final completion : approximately 3.5 years after FSI|Full analysis set (FAS) population comprised of all randomised patients.||Months||Inter-Quartile Range|Median
656574|NCT01933932|Primary|Progression-Free Survival (PFS)|Progression free survival is defined as the time from randomisation until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression)|Measured at baseline until the date of first documented objective disease progression. Estimated final completion : approximately 3 years after first subject in (FSI)|Full analysis set (FAS) population comprised of all randomised patients.||Months||Inter-Quartile Range|Median
656576|NCT01933880|Secondary|Percentage of Participants With Total Score of IO Sub-scale Less Than or Equal to 5 in IOWA Conners Measurement Scale at Week 12|Remission rate in different dosage groups will be accessed to evaluate the relationship between therapeutic effect and dosage. Remission rate is the percentage of participants with total score of IO sub-scale less than or equal to 5 in IOWA Conners measurement scale.|Week 12|"FAS population for OROS-MPH Group included all participants who received at least one study drug therapy and had at least one efficacy evaluation. Here N signifies participants who were evaluable for this outcome measure."||Percentage of participants|||Number
656577|NCT01933880|Secondary|Change From Baseline in Completion Time of Stroop Color-word Test at Week 12|Completion time of stroop color-word test in different dosage groups will be accessed to evaluate the relationship between therapeutic effect and dosage. This is a psychological test to observe the interference in which disparity between the meaning and color affects reading speed. A participant will be given 3 tasks of recognition: reading the printed colored ink (Color Test), reading color words in black ink (Word Test), and interference, reading color words printed in different colored ink (Word-Color Test). The test will be scored on the number of correct answers. There are 100 items for each of the three categories and if they made it through the 100 words with time remaining, they would repeat the list. Median time of the naming time in the Stroop color word naming test will be accessed. Stroop color word naming test 1 ,2 ,3 and 4 stand for gradually increased difficulty and each test has a corresponding baseline and endpoint.|Baseline and End of Week 12|"FAS population for OROS-MPH Group included all participants who received at least one study drug therapy and had at least one efficacy evaluation. Here N signifies participants who were evaluable for this outcome measure and n signifies participants who were evaluable at each time point for each specific arm."||Seconds||Standard Deviation|Mean
656578|NCT01933880|Secondary|Change From Baseline in Total Scores of Digit Span Test at Week 12|The digit span test total score will be accessed in different dosage groups to evaluate the relationship between therapeutic effect and dosage. The digit span test is mainly used to measure the ability of short-term memory and attention. The participant will be given a string of digits and asked to repeat them forward, and then a second string of digits to repeat backward. The score is the number of correct responses, where the digits were repeated correctly. One point will be given for each correctly repeated string of digits. The maximum subscore in the Digits Forward is16, and the maximum subscore in the Digits Backward is 14, for a total score of 30. A higher score was indicative of better recall and attention.|Baseline and End of Week 12|"FAS population for OROS-MPH Group included all participants who received at least one study drug therapy and had at least one efficacy evaluation. Here N signifies participants who were evaluable for this outcome measure."||Scores on a scale||Standard Deviation|Mean
656579|NCT01933880|Secondary|Change From Baseline in I/O Score of IOWA Conners Behavior Rating Scale at Week 12|IOWA conners behavior rating scale score in different dosage groups will be accessed to evaluate relationship between therapeutic effect and dosage. IOWA Conners Behavior Rating Scale evaluated by parents provides accurate measurement standards for behavioral change and therapeutic response. It includes 2 sub-scales: Inattention/Overactivity (I/O) subscale and Attacks (A), also known as Opposition/Defiant (O/D) sub-scale. IO (primary measurement ) will be assessed using 5-items and all Items will be scored on a 4-point scale (from 0=not at all to 3=very much). Total score range is from 0 to 15. Higher scores indicate worsening.|Baseline and End of Week 12|"FAS population for OROS-MPH Group included all participants who received at least one study drug therapy and had at least one efficacy evaluation. Here N signifies participants who were evaluable for this outcome measure."||Scores on a scale||Standard Deviation|Mean
656580|NCT01933880|Secondary|Number of Participants With Clinical Global Impression - CGI Scale Score|CGI is an overall rating scale. Clinical Global Impression (Improvement of Diseases) is divided into seven grades: 1=very significant improvement, 24=significant improvement or advanced, 3=improvement or slightly advanced, 4=no change, 5=slight aggravation, 6=significant aggravation, and 7=very significant aggravation or seriously aggravated. Number of participants in each category of grade were assessed.|End of Week 1, 2, 3, 7 and 12|FAS population for OROS-MPH Group included all participants who received at least one study drug therapy and had at least one efficacy evaluation. Data for Normal group was not analyzed for IOWA Conners scale since as per the planned analysis normal participants were only analyzed for the memory effect in cognitive function test||Participants|||Number
656581|NCT01933880|Secondary|Academic Achievement|Mathematics and language scores will be obtained from their corresponding examinations at school. Scores ranges from 0-100 respectively. Mathematics and language would be summarized separately.|Baseline and End of Week 12|"FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm."||scores on a scale||Standard Deviation|Mean
656582|NCT01933880|Secondary|Coding Test|The coding Test is a common test indicator for perceptual speed. The test presents a series of corresponding relationship between graphics and symbols to the participant, and then participants will be required to fill out the appropriate symbol following single symbol in the test part. The test is limited within 150 seconds and evaluated the number of symbols been replaced correctly by the participants.|Baseline and End of Week 12|"FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm."||Number of symbols correctly replaced||Standard Deviation|Mean
656599|NCT01933880|Primary|Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 7|IOWA Conners Behavior Rating Scale evaluated by parents provides accurate measurement standards for behavioral change and therapeutic response. It includes 2 sub-scales: Inattention/Overactivity (I/O) subscale and Attacks (A), also known as Opposition/Defiant (O/D) sub-scale. IO (primary measurement ) will be assessed using 5-items and all Items will be scored on a 4-point scale (from 0=not at all to 3=very much). Total score range is from 0 to 15. Higher scores indicate worsening.|Baseline and Week 7|"FAS population for OROS-MPH Group. Here N signifies number of participants who were evaluable for this outcome measure. Data for Normal group was not analyzed for IOWA Conners scale since as per the planned analysis normal participants were only analyzed for the memory effect in cognitive function test."||Scores on a scale||Standard Deviation|Mean
656583|NCT01933880|Secondary|WCST: Learning to Learn (L-C)|"WCST is used to evaluate participants’ abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants’ cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. Learning to learn indicator was a measure of decrement in the number of responses needed to achieve each successive category. The raw score ranged from 0 to 100. The high, negative value suggests the participants could not effectively learn the task presented by the WCST. Only calculated in those completed 3 or more categories and not linear (cannot be considered to be good or bad just judged by the number, analyzed with other factors case by case)."|Baseline and End of Week 12|"FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm."||number of responses||Standard Deviation|Mean
656584|NCT01933880|Secondary|WCST: Failure to Maintain Set (Fm)|WCST is used to evaluate participants’ abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants’ cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. The frequency (number of times) of responses completed with 5 to 9 continuous correct was evaluated. Ranges from 0 to 26 and was not linear (cannot be considered to be good or bad just judged by the number, analyzed with other factors case by case).|Baseline and End of Week 12|"FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm."||number of times||Standard Deviation|Mean
656585|NCT01933880|Secondary|WCST: Non-Persistent Error Responses (nRpe)|WCST is used to evaluate participants’ abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants’ cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. Non perseverative error responses are the errors remaining after subtracting persistent errors from total errors. Ranges from 0 to 128 and was not linear (cannot be considered to be good or bad just judged by the number, analyzed with other factors case by case).|Baseline and End of Week 12|"FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm."||number of non-persistent error responses||Standard Deviation|Mean
656586|NCT01933880|Secondary|WCST: Percentage of Perseverative Error Responses (Rpe%)|WCST is used to evaluate participants’ abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants’ cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative (pvt) errors; nonperseverative errors; failure to maintain set; learning to learn. Percentage of persistent errors out of total number of responses was evaluated. Ranges from 0 to 100%, the less the better.|Baseline and End of Week 12|"FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm."||Percentage of pvt error responses||Standard Deviation|Mean
656587|NCT01933880|Secondary|WCST: Perseverative Error Responses (Rpe)|WCST is used to evaluate participants’ abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants’ cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. Perseverative error responses are the number of responses which applied continuity principle for matching answers and also had the wrong answer was evaluated. Ranges from 0 to 128, the less the better.|Baseline and End of Week 12|"FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm."||number of perseverative error responses||Standard Deviation|Mean
656600|NCT01933880|Primary|Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 3|IOWA Conners Behavior Rating Scale evaluated by parents provides accurate measurement standards for behavioral change and therapeutic response. It includes 2 sub-scales: Inattention/Overactivity (I/O) subscale and Attacks (A), also known as Opposition/Defiant (O/D) sub-scale. IO (primary measurement ) will be assessed using 5-items and all Items will be scored on a 4-point scale (from 0=not at all to 3=very much). Total score range is from 0 to 15. Higher scores indicate worsening.|Baseline and Week 3|"FAS population for OROS-MPH Group. Here N signifies number of participants who were evaluable for this outcome measure. Data for Normal group was not analyzed for IOWA Conners scale since as per the planned analysis normal participants were only analyzed for the memory effect in cognitive function test."||Scores on a scale||Standard Deviation|Mean
656588|NCT01933880|Secondary|WCST: Perseverative Responses (Rp)|WCST is used to evaluate participants’ abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants’ cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. Number of perseverative responses were the responses which applied continuity principle for matching answers was evaluated. Ranges from 0 to 100, the less the better.|Baseline and End of Week 12|"FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm."||number of perseverative responses||Standard Deviation|Mean
656589|NCT01933880|Secondary|WCST: Percentage of Conceptual Level Responses (Rf%)|WCST is used to evaluate participants’ abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants’ cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. Percentage of the responses completed with 3-10 continuous correct during the entire measuring process was evaluated. Ranges from 0 to 100%, the more the better.|Baseline and End of Week 12|"FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm."||percentage of conceptual level responses||Standard Deviation|Mean
656590|NCT01933880|Secondary|WCST: First Response (Rf)|WCST is used to evaluate participants’ abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants’ cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. Number of responses needed to complete the first color classification was evaluated. Ranges from 9 to 128, the lesser the better.|Baseline and End of Week 12|"FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm."||number of first responses||Standard Deviation|Mean
656591|NCT01933880|Secondary|WCST: Percentage of Correct Responses (Rc%)|WCST is used to evaluate participants’ abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants’ cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. Percentage of correct responses which meets all the requirements according to the response principles was evaluated. Ranges from 0 to 100 percent (%), the more the better.|Baseline and End of Week 12|"FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm."||Percentage of correct responses||Standard Deviation|Mean
656592|NCT01933880|Secondary|WCST: Error Responses (Re)|WCST is used to evaluate participants’ abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants’ cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. Number of error responses which did not comply with the response principles was evaluated. Ranges from 0 to 128, the less the better.|Baseline and End of Week 12|"FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm."||number of error responses||Standard Deviation|Mean
656601|NCT01933880|Primary|Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 2|IOWA Conners Behavior Rating Scale evaluated by parents provides accurate measurement standards for behavioral change and therapeutic response. It includes 2 sub-scales: Inattention/Overactivity (I/O) subscale and Attacks (A), also known as Opposition/Defiant (O/D) sub-scale. IO (primary measurement ) will be assessed using 5-items and all Items will be scored on a 4-point scale (from 0=not at all to 3=very much). Total score range is from 0 to 15. Higher scores indicate worsening.|Baseline and Week 2|"FAS population for OROS-MPH Group. Here N signifies number of participants who were evaluable for this outcome measure. Data for Normal group was not analyzed for IOWA Conners scale since as per the planned analysis normal participants were only analyzed for the memory effect in cognitive function test."||Scores on a scale||Standard Deviation|Mean
657597|NCT01919229|Secondary|PK (Pharmacokinetics) Parameters, Including But Not Limited to, Cmax, Tmax, AUClast for LEE011 (and Any Relevant Metabolites) and Letrozole.||Days 1, 8, 14 and 15|Since the study was terminated, no efficacy data was obtained.|||||
656593|NCT01933880|Secondary|WCST: Correct Responses (Rc)|WCST is used to evaluate participants’ abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants’ cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. The number of correct responses which meets all the requirements according to the response principles was evaluated. Ranges from 0-116, the more the better.|Baseline and End of Week 12|"FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm."||number of correct responses||Standard Deviation|Mean
656594|NCT01933880|Secondary|WCST: Completed Categories (Cc)|WCST is used to evaluate participants’ abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants’ cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. In completed categoriies, number of categories completed out of 6 sorting categories after the test was evaluated. Ranges from 0 to 6. The more the number of categories completed the better is the response.|Baseline and End of Week 12|"FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm."||Nunber of Categories Completed||Standard Deviation|Mean
656595|NCT01933880|Secondary|Wisconsin Card Sorting Test (WCST): Administered Responses (Ra) of Completed Examination|WCST is used to evaluate participants’ abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants’ cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. During number of trials administered or administered responses, participants were administered 128 cards and asked to sort the cards until all the 6 sorting categories was completed. Response number used to complete all 6 categories ranges from 50 to 128, lesser the better.|Baseline and End of Week 12|"FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm."||Responses||Standard Deviation|Mean
656596|NCT01933880|Secondary|Stroop Color Word Naming Test|This is a psychological test to observe the interference in which disparity between the meaning and color affects reading speed. A participant will be given 3 tasks of recognition: reading the printed colored ink (Color Test), reading color words in black ink (Word Test), and interference, reading color words printed in different colored ink (Word-Color Test). The test is scored on the number of correct answers. There are 100 items for each of the three categories and if they made it through the 100 words with time remaining, they would repeat the list. Median naming time in the Stroop color word naming test will be assessed. Stroop color word naming test 1 ,2 ,3 and 4 stand for gradually increased difficulty and each test has a corresponding baseline and endpoint.|Baseline and End of Week 12|FAS for OROS-MPH Group included participants who took at least 1 study drug therapy and had at least 1 efficacy evaluation. FAS for normal group included participants who had baseline assessment scale evaluation and had at least 1 endpoint assessment scale evaluation. ‘n’=participants who were evaluable at each specific time point for each arm.||Seconds||Standard Deviation|Mean
656597|NCT01933880|Secondary|Percentage of Participants With Total Score of IO Sub-scale Less Than or Equal to 5 in IOWA Conners Measurement Scale.|Remission rate is the percentage of participants with total score of IO sub-scale less than or equal to 5 in IOWA Conners measurement scale|End of Week 1, 2, 3, 7 and 12|FAS population for OROS-MPH Group included all participants who received at least one study drug therapy and had at least one efficacy evaluation. Data for Normal group was not analyzed for IOWA Conners scale since as per the planned analysis normal participants were only analyzed for the memory effect in cognitive function test.||Percentage of Participants|||Number
656598|NCT01933880|Primary|Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 12|IOWA Conners Behavior Rating Scale evaluated by parents provides accurate measurement standards for behavioral change and therapeutic response. It includes 2 sub-scales: Inattention/Overactivity (I/O) subscale and Attacks (A), also known as Opposition/Defiant (O/D) sub-scale. IO (primary measurement ) will be assessed using 5-items and all Items will be scored on a 4-point scale (from 0=not at all to 3=very much). Total score range is from 0 to 15. Higher scores indicate worsening.|Baseline and Week 12|"FAS population for OROS-MPH Group. Here N signifies number of participants who were evaluable for this outcome measure. Data for Normal group was not analyzed for IOWA Conners scale since as per the planned analysis normal participants were only analyzed for the memory effect in cognitive function test."||Scores on a scale||Standard Deviation|Mean
656612|NCT01933672|Secondary|Number of Participants With Post-baseline Electrocardiograms (ECGs) Data Met Criteria of Potential Clinical Concern|ECG criteria of potential clinical concern were 1), PR interval: >=300 milliseconds (msec); >=25% increase when baseline >200 msec; or increase >=50% when baseline <=200 msec; 2), QRS interval: >=140 msec; >=50% increase from baseline; 3), QTc interval using Fridericia’s formula (QTcF interval): absolute value >=450 - <480 msec, >=480-<500 msec, >500 msec; absolute change 30 - <60, >=60 msec.|Day 1 up to Day 14|The safety analysis set was all participants who received at least one dose of randomized study treatment.||participants|||Number
656602|NCT01933880|Primary|Change From Baseline in Inattention/Overactivity With Aggression (IOWA) Conners Behavior Rating Scale - I/O Score at Week 1|IOWA Conners Behavior Rating Scale evaluated by parents provides accurate measurement standards for behavioral change and therapeutic response. It includes 2 sub-scales: Inattention/Overactivity (I/O) subscale and Attacks (A), also known as Opposition/Defiant (O/D) sub-scale. IO (primary measurement ) will be assessed using 5-items and all Items will be scored on a 4-point scale (from 0=not at all to 3=very much). Total score range is from 0 to 15. Higher scores indicate worsening.|Baseline and Week 1|"FAS population for OROS-MPH Group. Here N signifies number of participants who were evaluable for this outcome measure. Data for Normal group was not analyzed for IOWA Conners scale since as per the planned analysis normal participants were only analyzed for the memory effect in cognitive function test."||Scores on a scale||Standard Deviation|Mean
656603|NCT01933880|Primary|Change From Baseline in Digit Span Test Total Score at Week 12|The digit span test is mainly used to measure the ability of short-term memory and attention. The participant will be given a string of digits and asked to repeat them forward, and then a second string of digits to repeat backward. The score is the number of correct responses, where the digits were repeated correctly. One point will be given for each correctly repeated string of digits. The maximum subscore in the Digits Forward is 16, and the maximum subscore in the Digits Backward is 14, summed for a total score of 30. A higher score is indicative of better recall and attention.|Baseline and Week 12|Full Analysis Set (FAS) population for OROS-MPH Group included all participants who received at least one study drug therapy and had at least one efficacy evaluation. FAS for normal group included all participants who received baseline assessment scale evaluation and had at least one endpoint assessment scale evaluation.||Scores on a scale||Standard Deviation|Mean
656604|NCT01933776|Secondary|Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following a Single Booster Dose of Adacel™ Vaccine|"Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia.
China Food and Drug Administration (CFDA)-defined Grade 3 solicited reactions: Pain, incapacitating, unable to perform usual activities (Children, Group 2) and significant, prevents daily activity (Adults, Group 1); All Participants, Erythema and Swelling >30 mm; Fever (temperature) >39˚C; Headache, Malaise, and Myalgia, significant, prevents daily activity."|Day 0 up to Day 7 post-vaccination|Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set.||Participants|||Number
656605|NCT01933776|Primary|Number of Participants Reporting Serious Adverse Events and Grade 3 Adverse Reactions Following a Single Booster Dose of Adacel™ Vaccine|"Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia.
China Food and Drug Administration (CFDA)-defined Grade 3 solicited reactions: Pain, incapacitating, unable to perform usual activities (Children, Group 2) and significant, prevents daily activity (Adults, Group 1); All Participants, Erythema and Swelling >30 mm; Fever (temperature) >39˚C; Headache, Malaise, and Myalgia, significant, prevents daily activity."|Day 0 up to Day 28 post-vaccination|Serious adverse events and solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set.||Participants|||Number
656606|NCT01933672|Secondary|Plasma PF-04937319 Time for Cmax (Tmax) on Day 14|Tmax was time of maximum concentration. The PK parameters were summarized descriptively by treatment as appropriate.|Predose, 1.5, 3, 5, 6.5, 8, 11, 12.5, and 14 hours on Days 0 and 14; and predose on Days 7 and 15.|The PK population was defined as all randomized participants who received at least 1 dose of PF 04937319 and who had at least 1 PK sample with reported concentration.||hour||Full Range|Median
656607|NCT01933672|Secondary|Plasma PF-04937319 Lowest Observed Concentration During the 24-hour Period (Cmin) on Day 14|Cmin lowest observed concentration during the 24-hour period. The PK parameters were summarized descriptively by treatment as appropriate.|Predose, 1.5, 3, 5, 6.5, 8, 11, 12.5, and 14 hours on Days 0 and 14; and predose on Days 7 and 15.|The PK population was defined as all randomized participants who received at least 1 dose of PF 04937319 and who had at least 1 PK sample with reported concentration.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
656608|NCT01933672|Secondary|Plasma PF-04937319 Highest Observed Concentration (Cmax) on Day 14|Cmax was highest observed concentration. The PK parameters were summarized descriptively by treatment as appropriate.|Predose, 1.5, 3, 5, 6.5, 8, 11, 12.5, and 14 hours on Days 0 and 14; and predose on Days 7 and 15.|The PK population was defined as all randomized participants who received at least 1 dose of PF 04937319 and who had at least 1 PK sample with reported concentration.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
656609|NCT01933672|Secondary|Plasma PF-04937319 Average Concentration Over the 24-hour Period (Cav) on Day 14|Cav was average concentration over the 24-hour period. The PK parameters were summarized descriptively by treatment as appropriate.|Predose, 1.5, 3, 5, 6.5, 8, 11, 12.5, and 14 hours on Days 0 and 14; and predose on Days 7 and 15.|The PK population was defined as all randomized participants who received at least 1 dose of PF 04937319 and who had at least 1 PK sample with reported concentration.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
656610|NCT01933672|Secondary|Plasma PF-04937319 Apparent Clearance (CL/F) on Day 14|The PK parameters were summarized descriptively by treatment as appropriate. Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Predose, 1.5, 3, 5, 6.5, 8, 11, 12.5, and 14 hours on Days 0 and 14; and predose on Days 7 and 15.|The PK population was defined as all randomized participants who received at least 1 dose of PF 04937319 and who had at least 1 PK sample with reported concentration.||mL/min||Geometric Coefficient of Variation|Geometric Mean
656611|NCT01933672|Secondary|Plasma PF-04937319 Area Under the Concentration Time Curve From Time 0 to 24 Hours (AUC24) of PF-04937319 at Day 14|The PK parameters were summarized descriptively by treatment as appropriate. Two (2) PK parameters specified in the protocol and SAP were not reported: AUClast was not reported since it was the same as AUC24 in this study, and apparent volume of distribution (Vz/F) was not reported since the log-linear terminal phase of the concentration-time profiles was not consistently well characterized in the 24-hour sampling period.|Predose, 1.5, 3, 5, 6.5, 8, 11, 12.5, and 14 hours on Days 0 and 14; and predose on Days 7 and 15.|The PK population was defined as all randomized participants who received at least 1 dose of PF 04937319 and who had at least 1 PK sample with reported concentration.||ng•hr/mL||Geometric Coefficient of Variation|Geometric Mean
656613|NCT01933672|Secondary|Number of Participants With Vital Signs Data Met Criteria of Potential Clinical Concern|Vital signs included blood pressure (BP; supine, sitting and standing) and pulse rate. Vital signs criteria of potential clinical concern were 1), BP: sitting systolic BP (SBP) greater than or equal to (>=) 30 millimeters of mercury (mm Hg) change from baseline, sitting SBP =<20 mmHg change from baseline, supine/sitting/standing SBP less than (<) 90 mm Hg; sitting diastolic BP (DBP) >=20 mm Hg change from baseline, sitting SBP =<20 mmHg change from baseline, supine/sitting/standing DBP <50 mm Hg; 2), pulse rate (supine): <40 or greater than (>) 120 beats per minute (bpm).|Day 1 up to Day 14|The safety analysis set was all participants who received at least one dose of randomized study treatment.||participants|||Number
656614|NCT01933672|Secondary|Change From Baseline in Body Weight (kg)||Day 1 up to Day 14|The safety analysis set was all participants who received at least one dose of randomized study treatment.||kg||Standard Error|Mean
656615|NCT01933672|Secondary|Frequency of Laboratory Test Abnormalities Reported in Any Treatment Group|The total number of participants with laboratory test abnormalities (without regard to baseline abnormality) was assessed.|Day 1 up to Day 14|The safety analysis set was all participants who received at least one dose of randomized study treatment.||participants|||Number
656616|NCT01933672|Secondary|Incidence of All Causality Treatment-Emergent Adverse Event by Preferred Term (Frequency Rate >5%)||Day 1 up to Day 14|The safety analysis set was all participants who received at least one dose of randomized study treatment. HAEs meeting protocol definition were summarized descriptively by treatment.||participants|||Number
656617|NCT01933672|Secondary|Change From Baseline in Pre-meal Insulin on Day 14|Blood samples for measurement of glucose to permit derivation of pre-meal collections of blood samples for insulin at 0, 5 and 11 hours on Day 0 (baseline) and Day 14.|Day 14|Full analysis set defined as all randomized subjects who had taken at least 1 dose of blinded study medication and who had both a baseline and a post-baseline WMDG assessment. Number of participants analyzed was the evaluable participants with a measurement on Day 14.||micro international unit/milliliter||Standard Error|Least Squares Mean
656618|NCT01933672|Secondary|Change From Baseline in Pre-meal C-Peptide on Day 14|Blood samples for measurement of glucose to permit derivation of pre-meal collections of blood samples for C-peptide at the pre-specified nominal timepoints at predose, 5 and 11 hours on Day 0 (baseline) and Day 14.|Day 14|Full analysis set defined as all randomized subjects who had taken at least 1 dose of blinded study medication and who had both a baseline and a post-baseline WMDG assessment. Number of participants analyzed was the evaluable participants with a measurement on Day 14.||nanograms/milliliter (ng/mL)||Standard Error|Least Squares Mean
656619|NCT01933672|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Day 14|Blood samples for measurement of glucose to permit derivation of pre-meal collections at the pre-specified nominal timepoints of each period: predose (ie, time “0”), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 16 and 20 hours on Day 0 (baseline) and Day 14; and predose on Days 1 and 15.|Day 14|Full analysis set defined as all randomized subjects who had taken at least 1 dose of blinded study medication and who had both a baseline and a post-baseline WMDG assessment. Number of participants analyzed was the evaluable participants with a measurement on Day 14.||mg/dL||Standard Error|Least Squares Mean
656620|NCT01933672|Primary|Change From Baseline in Weighted Mean Daily Glucose (WMDG) at Day 14|Plasma glucose concentration was determined predose (Hour 0) and at 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 16, 20, and 24 hours postdose on Days 0 (baseline) and 14. WMDG was calculated as the area under the curve (AUC) of the 12-point plasma glucose concentration-time profile divided by 24 hours.|Prior to morning dose (Hour 0) and at 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 16, 20, and 24 hours post morning dose on Days 0 (baseline) and Day 14|Full analysis set defined as all randomized subjects who had taken at least 1 dose of blinded study medication and who had both a baseline and a post-baseline WMDG assessment. Number of participants analyzed was the evaluable participants with a measurement at both baseline and on Day 14.||milligram/deciliter (mg/dL)||Standard Error|Least Squares Mean
656621|NCT01933425|Secondary|Surgical Conditions During Suturing of the Abdominal Fascia|Optimal (score 1) Good (score 2) Acceptable (score 3) Poor (score 4)|1 hour|Evaluation of surgical conditions was compared using Mann–Whitney U-test.||participants|||Number
656622|NCT01933425|Secondary|Intraabdominal Distance (Centimeters)|Difference in intraabdominal distance from promontorium to the edge of the trocar in umbilicus at 8 mmHg with and without deep neuromuscular blockade (PTC 0-1).|1 hour|Comparisons of changes in distances were performed with paired t-test||centimeters||95% Confidence Interval|Median
656623|NCT01933425|Primary|Intraabdominal Distance (Centimeters)|Difference in intraabdominal distance from promontorium to the edge of the trocar in umbilicus at 12 mmHg with and without deep neuromuscular blockade (PTC 0-1).|1 hour|Comparisons of changes in distances were performed with paired t-test.||centimeters||Full Range|Median
656624|NCT01933399|Secondary|Change Score in the Patient Specific Activity Scale|Change score from baseline and the score at the second week. Compare score change to the minimal clinically important difference and analyze for statistical significance between the baseline and the 2nd week score, and the statistical difference in the change scores across the 3 groups. Scores from 0 to 10 with a higher score representing higher function and a lower score representing a decrease function.|Baseline and 2-weeks|||units on a scale||95% Confidence Interval|Mean
656625|NCT01933399|Primary|Change Score in the Self-assessment of Disability as Measured by Oswestry Disability Index (ODI)|Change score from baseline and the score at the second week. The Oswestry Disabilty Index is a 100 point self-assessment of disabilty due to lower back pain or complications from lower back pain. A score of 40 or more points is interpreted as signficant disability due to lower back pain. A score between 20 and 40 respresents disability, but the individual is still able to function to some degree with activities of daily living, but has to modify their behavior. A score less than 20 implies that the disabilty due to the lower back pain is not greatly impacting a wide range of functions. Compare score change to the minimal clinically important difference between the baseline and the 2nd week score, and the difference in the change scores across the 3 groups.|Baseline and 2 weeks|||units on a scale||95% Confidence Interval|Mean
656655|NCT01932606|Secondary|Change in PA Compliance After Study Drug (Exercise)|Values are exercise values after receiving study drug minus exercise values before study drug (on the same day.) Pulmonary artery compliance is an index of the elasticity of the blood vessel, an indication of arterial stiffness.|baseline, approximately 30 minutes after study drug administration|||ml/mm Hg||Standard Deviation|Mean
656626|NCT01933334|Secondary|University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores|UCLA SCTC GIT Scale 2.0 is a 34-item self-administered questionnaire to obtain participant’s assessment of the frequency of GI symptoms in preceding 7 days and how symptoms affected his/her life. All but 2 items were scored on a 0 to 3 scale (0=better health, 3=worse health); remaining 2 items were scored as 0 (better health) and 1 (worse health). The 34 items are divided into seven scales (reflux, distention/bloating, fecal soilage, diarrhea, social functioning, emotional well-being, and constipation). Individual scale score was calculated as the average of the items in the scale. Individual scale score ranged from 0 to 3 for reflux, distention/bloating, fecal soilage, social functioning, and emotional well-being; 0 to 2 for diarrhea; and 0 to 2.5 for constipation. A total score was also calculated as the average of 6 of the 7 scales (omitting constipation) and ranged from 0 to 2.83. For individual and total scores 0 indicated better health and higher score indicates worse health.|Baseline, Weeks 4, 8, 12, and 16|Safety population. n = number of participants analyzed at specified time.||units on a scale||Standard Deviation|Mean
656627|NCT01933334|Primary|Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs)|An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|From baseline up to 28 days after the last dose of study drug (last dose = Week 16)|Safety population included all randomized participants who provided written informed consent and received at least one dose of study treatment.||percentage of participants|||Number
656628|NCT01933334|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (AEs)|Percentage of participants who had treatment-emergent AEs, defined as newly occurring or worsening after first dose. Relatedness to (study drug) was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.|From baseline up to 28 days after the last dose of study drug (last dose = Week 16)|Safety population included all randomized participants who provided written informed consent and received at least one dose of study treatment.||percentage of participants|||Number
656629|NCT01933230|Primary|To Determine if Neck Cooling Affects Brain Temperature.||During the 2 hours of neck cooling||||||
656630|NCT01933230|Primary|To Determine if Neck Cooling Affects Intracranial Pressure||During 2 hours of neck cooling||||||
656631|NCT01933230|Primary|Temperature Reduction by 1 Degree Per Hour in the ICU Setting.|Temperature reduction by 1 degree per hour in the Intensive Care Unit setting.|During the 2 hours of neck cooling|||degrees celsius||Standard Deviation|Mean
656632|NCT01933048|Other Pre-specified|Feasibility of Self-administration Following Vaccine Administration||28+/- 7 days post-vaccination|Numbers include participants randomized to the SA group only.||participants|||Number
656633|NCT01933048|Other Pre-specified|Feasibility of Self-administration Prior to Vaccine Administration||28+/- 7 days post-vaccination|||participants|||Number
656634|NCT01933048|Secondary|Difference and Proportion in Seroconversion of Subjects||28+/- 7 days post-vaccination|||participants|||Number
656635|NCT01933048|Secondary|Difference and Proportion in Seroresponse of Subjects||28+/- 7 days post-vaccination|||participants|||Number
656636|NCT01933048|Primary|Post-vaccination Geometric Mean Titer (GMT) Ratios Between HCWA and SA Subjects||28+/- 7 days post-vaccination|||titer ratio||95% Confidence Interval|Geometric Mean
656637|NCT01932970|Other Pre-specified|Percentage of Participants With Symptomatic Hypocalcemia During the 4-week Treatment Period|Hpocalcemia was used for events of decreased calcium accompanied by clinical signs and symptoms of hypocalcemia.|From the first dose of study drug up to 30 days after the last dose; 8 weeks|Participants who received at least one dose of study drug||percentage of participants||95% Confidence Interval|Number
656638|NCT01932970|Other Pre-specified|Number of Participants With Adverse Events||From the first dose of study drug up to 30 days after the last dose; 8 weeks|All participants who received at least one dose of study drug||participants|||Number
656639|NCT01932970|Secondary|Percentage of Participants With Serum Corrected Calcium < 8.3 mg/dL During the 4-week Treatment Period||4 weeks|Full analysis set||percentage of participants||95% Confidence Interval|Number
656640|NCT01932970|Secondary|Percent Change From Baseline in Parathyroid Hormone During the Treatment Period||Baseline and weeks 2, 3 and 4|Full analysis set with available data at each time point||percent change||Standard Error|Mean
656641|NCT01932970|Primary|Percentage of Participants With Serum Corrected Calcium < 7.5 mg/dL During the 4-week Treatment Period||4 weeks|Full analysis set||percentage of participants||95% Confidence Interval|Number
656642|NCT01932762|Secondary|Percentage of Participants Achieving SVR24|SVR24 was defined as HCV RNA <25 IU/mL, either TD(u) or TND, at 24 weeks after the end of all study therapy. The percentage of participants with SVR24 and accompanying 95% CIs were reported for each treatment arm of the PP Population.|24 weeks after end of all therapy (Study Week 36)|All participants in the PP Population (all randomized participants receiving ≥1 dose of study therapy and with no important protocol deviations) with available data.||percentage of participants||95% Confidence Interval|Number
656643|NCT01932762|Secondary|Percentage of Participants Achieving SVR4|SVR4 was defined as HCV RNA <25 IU/mL, either TD(u) or TND, at 4 weeks after the end of all study therapy. The percentage of participants with SVR4 and accompanying 95% CIs were reported for each treatment arm of the PP Population.|4 weeks after end of all therapy (Study Week 16)|All participants in the PP Population (all randomized participants receiving ≥1 dose of study therapy and with no important protocol deviations) with available data.||percentage of participants||95% Confidence Interval|Number
656656|NCT01932606|Secondary|Change in PVR After Study Drug (Exercise)|Values are exercise values after receiving study drug minus exercise values before study drug (on the same day.) Pulmonary Vascular Resistance (PVR) is the resistance to flow that must be overcome to push blood through the pulmonary vasculature. Acute and chronic lung disease can both cause an increase in PVR. Chronic PVR can lead to right sided heart failure.|baseline, approximately 30 minutes after study drug administration|||mm Hg/L/min||Standard Deviation|Mean
656657|NCT01932606|Secondary|Change in Blood Pressure After Study Drug (Exercise)|Values are exercise values after receiving study drug minus exercise values before study drug (on the same day.)|baseline, approximately 30 minutes after study drug administration|||mm Hg||Standard Deviation|Mean
656644|NCT01932762|Secondary|Percentage of Participants Achieving HCV RNA <25 IU/mL During Treatment By Timepoint|HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at TWs 1, 2, 4, 8, and 12. The Roche COBAS™ Taqman™ HCV Test (v.2.0) has a lower limit of quantification (LLoQ) of 25 IU/ml and a limit of detection of 9.3 IU/ml. The percentage of participants with HCV RNA levels <25 IU/ml (either TD[u] or TND) and accompanying 95% CIs were reported at TW2, TW4, and TW12 for each treatment arm of the PP Population.|From TW 2 through TW 12 (up to 12 weeks)|All participants in the PP Population (all randomized participants receiving ≥1 dose of study therapy and with no important protocol deviations) with available data.||percentage of participants||95% Confidence Interval|Number
656645|NCT01932762|Secondary|Percentage of Participants Achieving Undetectable HCV RNA During Treatment By Timepoint|HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at TWs 1, 2, 4, 8, and 12. Undetectable HCV RNA (or TND) was defined as below the 9.3 IU/ml limit of detection. The percentage of participants achieving undetectable HCV RNA and accompanying 95% CIs were reported at TW2, TW4, and TW12 for each treatment arm of the PP Population.|From TW 2 through TW 12 (up to 12 weeks)|All participants in the PP Population (all randomized participants receiving ≥1 dose of study therapy and with no important protocol deviations) with available data.||percentage of participants||95% Confidence Interval|Number
656646|NCT01932762|Secondary|Mean Time to First Achievement of Undetectable HCV RNA During Treatment|HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at TWs 1, 2, 4, 8, and 12. Undetectable HCV RNA (or TND) was defined as below the 9.3 IU/ml limit of detection. Kaplan Meier summary statistics were calculated for each treatment arm in the Full Analysis Set (FAS).|From TW1 until first achievement of undetectable HCV RNA (up to 12 weeks)|FAS; all randomized participants who received ≥1 dose of study therapy. Participants in the FAS not achieving TND were censored from the analysis.||days||Standard Error|Mean
656647|NCT01932762|Primary|Percentage of Participants With Adverse Events (AEs), Serious AEs (SAEs), Drug-Related AEs, Drug-Related SAEs, or Discontinuation of Study Treatment Due to AE During the Treatment Period and First 14 Follow-up Days|AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol-specified procedure, whether or not considered related to the medicinal product/protocol-specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE. An SAE was an AE that resulted in death, was life threatening, resulted in persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a cancer, was associated with an overdose, was another important medical event. The investigator determined the relationship of the AE to the treatment as unrelated or possibly, probably, or definitely related.|Treatment period plus the first 14 days of follow-up (up to 14 weeks)|All-Subjects-As-Treated (ASAT) Population; all randomized participants who received ≥ 1 dose of study therapy. The percentage of participants with specific AEs and accompanying 95% CI were reported for each treatment arm.||percentage of participants||95% Confidence Interval|Number
656648|NCT01932762|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After The End of Study Therapy (SVR12)|SVR12 was defined as Hepatitis C Virus ribonucleic acid (HCV RNA) <25 IU/mL, either target detected but unquantifiable (TD[u]) or target not detected (TND), at 12 weeks after the end of all study therapy. The percentage of participants with SVR12 and accompanying 95% confidence intervals (CIs) were reported for each treatment arm in the Per-Protocol (PP) Population.|12 weeks after end of all therapy (Study Week 24)|All participants in the PP Population (all randomized participants receiving ≥1 dose of study therapy with no important protocol deviations) with available data.||percentage of participants||95% Confidence Interval|Number
656649|NCT01932606|Secondary|Change in Stroke Volume After Study Drug (Exercise)|Values are exercise values after receiving study drug minus exercise values before study drug (on the same day.) Stroke volume is the amount of blood pumped out of the heart (left ventricle - to the body) during each contraction.|baseline, approximately 30 minutes after study drug administration|||ml||Standard Deviation|Mean
656650|NCT01932606|Secondary|Change in Cardiac Output After Study Drug (Exercise)|Values are exercise values after receiving study drug minus exercise values before study drug (on the same day.) Cardiac output is equal to the stroke volume (the amount of blood pumped from a ventricle in a single heartbeat) times the heart rate.|baseline, approximately 30 minutes after study drug administration|||L/min||Standard Deviation|Mean
656651|NCT01932606|Secondary|Change in Arteriovenous Oxygen Difference After Study Drug (Exercise)|Arteriovenous oxygen difference is the difference in the oxygen content of the blood between the arterial blood and the venous blood. It is an indication of how much oxygen is removed from the blood in capillaries as the blood circulates in the body.|baseline, approximately 30 minutes after study drug administration|||ml/dl||Standard Deviation|Mean
656652|NCT01932606|Secondary|Change in Oxygen Consumption (VO_2) After Study Drug (Exercise)|Values are exercise values after receiving study drug minus exercise values before study drug (on the same day.)|baseline, approximately 30 minutes after study drug administration|||ml/min||Standard Deviation|Mean
656653|NCT01932606|Secondary|Change in LVSW After Study Drug (Exercise)|Values are exercise values after receiving study drug minus exercise values before study drug (on the same day.) Stroke work refers to the work done by the ventricle to eject a volume of blood (i.e., stroke volume) into the aorta. Ventricular stroke work can be estimated as the product of stroke volume and mean aortic pressure during ejection.|baseline, approximately 30 minutes after study drug administration|||g/beat||Standard Deviation|Mean
656654|NCT01932606|Secondary|Change in SVR After Study Drug (Exercise)|Values are exercise values after receiving study drug minus exercise values before study drug (on the same day.) Systemic vascular resistance (SVR) refers to the resistance to blood flow offered by all of the systemic vasculature, excluding the pulmonary vasculature.|baseline, approximately 30 minutes after study drug administration|||dyne/s * cm^5||Standard Deviation|Mean
656658|NCT01932606|Secondary|Change in Heart Rate After Study Drug (Exercise)|Values are exercise values after receiving study drug minus exercise values before study drug (on the same day.)|baseline, approximately 30 minutes after study drug administration|||beats/minute||Standard Deviation|Mean
656660|NCT01932606|Secondary|Change in Stroke Volume After Study Drug (Resting)|Values are resting values after receiving study drug minus resting values before study drug (on the same day.) Stroke volume is the amount of blood pumped out of the heart (left ventricle - to the body) during each contraction.|baseline, approximately 30 minutes after study drug administration|||ml||Standard Deviation|Mean
656661|NCT01932606|Secondary|Change in Cardiac Output After Study Drug (Resting)|Values are resting values after receiving study drug minus resting values before study drug (on the same day.) The volume of blood pumped per minute by each ventricle of the heart. Cardiac output is equal to the stroke volume (the amount of blood pumped from a ventricle in a single heartbeat) times the heart rate.|baseline, approximately 30 minutes after study drug administration|||L/min||Standard Deviation|Mean
656662|NCT01932606|Secondary|Change in Arteriovenous Oxygen Content Difference After Study Drug (Resting)|Values are resting values after receiving study drug minus resting values before study drug (on the same day.) Arteriovenous oxygen difference is the difference in the oxygen content of the blood between the arterial blood and the venous blood. It is an indication of how much oxygen is removed from the blood in capillaries as the blood circulates in the body.|baseline, approximately 30 minutes after study drug administration|||ml/dl||Standard Deviation|Mean
656663|NCT01932606|Secondary|Change in Oxygen Consumption (VO_2) After Study Drug (Resting)|Values are resting values after receiving study drug minus resting values before study drug (on the same day.)|baseline, approximately 30 minutes after study drug administration|||ml/min||Standard Deviation|Mean
656664|NCT01932606|Secondary|Change in Left Ventricular Stroke Work (LVSW) After Study Drug (Resting)|Values are resting values after receiving study drug minus resting values before study drug (on the same day.) Stroke work refers to the work done by the ventricle to eject a volume of blood (i.e., stroke volume) into the aorta. Ventricular stroke work can be estimated as the product of stroke volume and mean aortic pressure during ejection.|baseline, approximately 30 minutes after study drug administration|||g/beat||Standard Deviation|Mean
656665|NCT01932606|Secondary|Change in Systemic Vascular Resistance (SVR) After Study Drug (Resting)|Values are resting values after receiving study drug minus resting values before study drug (on the same day.) Systemic vascular resistance (SVR) refers to the resistance to blood flow offered by all of the systemic vasculature, excluding the pulmonary vasculature.|baseline, approximately 30 minutes after study drug administration|||dyne/s * cm^5||Standard Deviation|Mean
656666|NCT01932606|Secondary|Change in Pulmonary Artery (PA) Compliance After Study Drug (Resting)|Values are resting values after receiving study drug minus resting values before study drug (on the same day.) Pulmonary artery compliance is an index of the elasticity of the blood vessel, an indication of arterial stiffness.|baseline, approximately 30 minutes after study drug administration|||ml/mm Hg||Standard Deviation|Mean
656667|NCT01932606|Secondary|Change in Pulmonary Vascular Resistance (PVR) After Study Drug (Resting)|Values are resting values after receiving study drug minus resting values before study drug (on the same day.) Pulmonary Vascular Resistance (PVR) is the resistance to flow that must be overcome to push blood through the pulmonary vasculature. Acute and chronic lung disease can both cause an increase in PVR. Chronic PVR can lead to right sided heart failure.|baseline, approximately 30 minutes after study drug administration|||mm Hg/L/min||Standard Deviation|Mean
656668|NCT01932606|Secondary|Change in Blood Pressure After Study Drug (Resting)|Values are resting values after receiving study drug minus resting values before study drug (on the same day.)|baseline, approximately 30 minutes after study drug administration|||mm Hg||Standard Deviation|Mean
656669|NCT01932606|Secondary|Change in Heart Rate After Study Drug (Resting)|Values are resting values after receiving study drug minus resting values before study drug (on the same day.)|baseline, approximately 30 minutes after study drug administration|||beats/minute||Standard Deviation|Mean
656670|NCT01932606|Secondary|Change in Central Pressures After Study Drug (Resting)|Values are resting values after receiving study drug minus resting values before study drug (on the same day.)|baseline, approximately 30 minutes after study drug administration|||mm Hg||Standard Deviation|Mean
656671|NCT01932606|Primary|Exercise Pulmonary Capillary Wedge Pressure (PCWP)|Pulmonary capillary wedge pressure (PCWP) provides an indirect estimate of left atrial pressure (LAP). PCWP is the pressure measured by wedging a pulmonary catheter with an inflated balloon into a small pulmonary arterial branch.|during repeat exercise run, approximately 30 minutes after study drug administration|||mm Hg||Standard Deviation|Mean
656672|NCT01932164|Primary|Quality of Bone Regeneration|The quality of bone formation will be conducted by analysis of CT scans of alveolar cleft area through canine tooth eruption in these position of new bone formation by tissue engineering techniques. We are waiting the canine eruption at the mouth.|Three months after the graft|||percentage of bone filling||80% Confidence Interval|Mean
656673|NCT01932164|Primary|Amount of New Bone Mass Formed|The quantification of bone formation will be conducted by analysis of CT scans of alveolar cleft area that receive autogenous mesenchymal stem cells from dental pulp associated with the biomaterial 3 and 6 months after surgical procedure ( tissue engineering ) in comparison with CT Scan previously of tissue engineering surgery.Preoperative and follow-up examinations reveled progressive alveolar bone union in all patients. For these 5 patients final completion of the alveolar defect with an 89,5% mean bone height was detected 6 months postoperatively. We are still waiting the canine dental eruption at the new bone. For these group of patients the bone tissue engineering using autologous mesenchymal stem cells associated with biomaterial resulted in satisfactory bone healing.|6 months from surgical procedure for alveolar grafting;|3 females and 2 males with cleft lip and palate||percentage of bone formation||95% Confidence Interval|Mean
656674|NCT01932112|Secondary|Atrial Fibrillation Recurrence|At 1 month, 3 month, 6 month and 12 months post ablation routine clinic visits, will perform electrocardiographically documented by electrogram (At 1,3,6,12 months post ablation) and Holter monitoring (At 12 months post ablation)|between 0 and 12 months||||||
656675|NCT01932112|Primary|Reconnection of Pulmonary Vein Electrogram After Adenosine Infusion|After pulmonary vein isolation, 20mg Intracardiac adenosine will be given to treatment group, will evaluate pulmonary vein reconnection.|5 minutes after IV adenosine|||participants|||Number
656676|NCT01932060|Secondary|Hemoglobin Indices After Cesarean Delivery|Study investigators will assess maternal hemoglobin levels at 24hr after cesarean delivery|24 hr after cesarean delivery|||g/dl||Inter-Quartile Range|Median
657598|NCT01919229|Secondary|Change From Baseline in Expression of Retinoblastoma Protein (pRB)||Baseline, Day 15|Since the study was terminated, no efficacy data was obtained.|||||
656678|NCT01931956|Other Pre-specified|Change in 6-Minute Walk Test (6MWT)|Defined as a cardiopulmonary function test that measures a patient’s exercise capacity by the distance he or she can walk in six minutes.|At Baseline and 12 months|"EU arm participants were not analyzed due to serious/life-threatening conditions, the 6MWT was not administered to all patients at baseline.Therefore, paired data at 1 year is not available for EU arm.
In CU arm 18 patients died prior to 1 year, 2 withdrew consent, 3 missed visit and 11 patients did not complete the 30-day 6MWT."||Meters||Standard Deviation|Mean
656679|NCT01931956|Other Pre-specified|Change in 6-Minute Walk Test (6MWT)|Defined as a cardiopulmonary function test that measures a patient’s exercise capacity by the distance he or she can walk in six minutes.|At Baseline and 30 Days|"EU arm participants were not analyzed due to serious/life-threatening conditions,the 6MWT was not administered to all patients at baseline.Therefore,paired data at 30 days is not available for EU arm.
In CU arm,36 participants were analyzed as 4 patients died prior to 30 days,2 withdrew consent and 17 patients did not complete the 30-day 6MWT."||Meters||Standard Deviation|Mean
656680|NCT01931956|Other Pre-specified|36-Item Short Form Health Survey (SF-36) Quality of Life|"The SF-36 is a multidimensional, patient-reported survey containing 36 questions on a 0-100 scale measuring physical (Physical Component Score PCS) & mental health status (Mental Component Score MCS) in relation to 8 health concepts:
Physical functioning
Role limitations due to physical or
Emotional health
Bodily pain
General health perceptions
Vitality
Social functioning
General mental health
Responses to each of the SF-36 items are scored and expressed as a score on a 0–100 scale (0% in a domain represents the poorest possible QOL&100% indicates full QOL).Higher scores represent better self-perceived health.
The physical & mental functions were assessed by the Physical Component Summary (PCS) score & Mental Component Summary (MCS) score. Normal PCS and MCS scores vary depending on the demographics of the population studied. The PCS&MCS norms for 65-75 year old are 44 & 52, respectively while the norms for CHF population are 31 & 46, respectively."|12 months|"EU arm participants were not analyzed due to the serious/life-threatening conditions, QOL data was not collected on all patients at baseline. Therefore, paired data at 1 year is not available for EU arm.
In CU arm 18 patients died prior to 1 year, 2 withdrew consent, 3 missed visit and SF-36 QOL instrument was not administered in 4 patients."||Scores on a scale||Standard Deviation|Mean
656681|NCT01931956|Other Pre-specified|36-Item Short Form Health Survey (SF-36) Quality of Life|"The SF-36 is a multidimensional, patient-reported survey containing 36 questions on a 0-100 scale measuring physical (Physical Component Score PCS) & mental health status (Mental Component Score MCS) in relation to 8 health concepts:
Physical functioning
Role limitations due to physical or
Emotional health
Bodily pain
General health perceptions
Vitality
Social functioning
General mental health
Responses to each of the SF-36 items are scored and expressed as a score on a 0–100 scale (0% in a domain represents the poorest possible QOL&100% indicates full QOL).Higher scores represent better self-perceived health.
The physical & mental functions were assessed by the Physical Component Summary (PCS) score & Mental Component Summary (MCS) score. Normal PCS and MCS scores vary depending on the demographics of the population studied. The PCS&MCS norms for 65-75 year old are 44 & 52, respectively while the norms for CHF population are 31 & 46, respectively."|30 days|"EU arm participants were not analyzed due to the serious/life-threatening conditions,SF-36 QOL data was not collected on all patients at baseline. Therefore, paired data at 30 days is not available for EU arm.
In CU arm 4 patients died prior to 30 days,2 withdrew consent and SF-36 QOL instrument was not administered in 9 patients."||Scores on a scale||Standard Deviation|Mean
656682|NCT01931956|Secondary|Hospital Re-admissions|Defined as re-admission of patients to the hospital following discharge from the Clip procedure.|30 days|||participants|||Number
656683|NCT01931956|Secondary|Incidence of Discharge to a Nursing Home or Skilled Nursing Facility|Defined as discharge to a nursing home or skilled nursing facility following discharge from the hospital after definitive treatment.|30 days|||participants|||Number
656684|NCT01931956|Secondary|Post-Procedure Intensive Care Unit (ICU)/ Critical Care Unit (CCU) Time|Defined as the number of hours patients are in an intensive care unit or step down unit before discharge or moving to a standard care unit.|30 days|||Hours||Standard Deviation|Mean
656685|NCT01931956|Secondary|Post-Procedure Length of Hospital Stay|Defined as the number of days from the end of the procedure until the patient is discharged from the hospital. This does not include time in a nursing or skilled care facility.|30 days|||Days||Standard Deviation|Mean
656686|NCT01931956|Secondary|Clip Implant Rate|Defined as the procedural rate of successful delivery and deployment of Clip implants with echocardiographic evidence of leaflet approximation and retrieval of the investigational delivery catheter.|On the day of index procedure (≤1 day)|||participants|||Number
656687|NCT01931956|Secondary|NYHA Functional Class|"Class I: Patients with cardiac disease but without resulting limitations of physical activity.
Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.
Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|12 months|"CU Arm:
Of total 59 subjects, NYHA Functional Class assessment was missing in 25 patients due to death (n=18), withdrawal (n=2), missed 1-year visit (n=3), or because it was not performed (n=2).
EU Arm:
Of total 7 subjects, NYHA Functional Class assessment was missing in 6 patients due to death (n=5) or missed 1-year visit (n=1)."||participants|||Number
656703|NCT01931878|Primary|Mean Total Restless Leg Syndrome Rating Scale Score|The Restless Legs Syndrome Rating Scale uses 10 questions, each scored 0-4, with higher scores representing more severe symptoms. Score ranges from 1-40. Scoring criteria are: Mild (score 1-10); Moderate (score 11-20); Severe (score 21-30); Very severe (score 31-40)|6 weeks|Total RLS scale score was compared between incoA injections and and saline group injections.||units on a scale||Standard Deviation|Mean
656704|NCT01931865|Other Pre-specified|Patients Improved in Patient Global Impression of Change (PGIC) Scale|The Patient Global Impression of Change questionaire asks patient level of satisfaction with current treatment (from very unsatisfactory to very satisfactory).|12 weeks|Advanced cancer patients||participants|||Number
657599|NCT01919229|Secondary|Change From Baseline in Electrocardiogram (ECG) Parameters||Baseline, Day 14|Since the study was terminated, no efficacy data was obtained.|||||
656688|NCT01931956|Secondary|New York Heart Association (NYHA) Functional Class|"Class I: Patients with cardiac disease but without resulting limitations of physical activity.
Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.
Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|30 days|"CU Arm:
Of total 59 subjects, NYHA Functional Class assessment was missing in 9 patients due to death (n=4), missed 30-day visit (n=2), or because it was not performed (n=3).
EU Arm:
Of total 7 subjects, NYHA Functional Class assessment was missing in 4 patients due to death (n=3) or because it was not performed (n=1)."||participants|||Number
656689|NCT01931956|Secondary|Clinical Durability|Defined as the proportion of patients who have an acute reduction in MR severity of at least one grade (as measured by the discharge echocardiogram) that at 12 months have not required surgery for valve dysfunction and meet either of the following: 1) MR severity grade of 2+ or less or 2) a one grade reduction in MR severity compared to baseline accompanied by at least a one level reduction in NYHA at 12 months.|12 months|||participants|||Number
656690|NCT01931956|Secondary|Procedural Success|Defined as successful implantation of the Clip(s) with resulting MR severity of 2+ of less at discharge or a 1 grade MR reduction at discharge accompanied by a 1 level reduction in NYHA at 30 days.|30 days|||participants|||Number
656691|NCT01931956|Secondary|Acute Procedural Success|Defined as successful implantation of the Clip(s) with resulting MR severity of 2+ or less as determined by the echocardiographic assessment at discharge. The 30-day echocardiogram will be used if the discharge echocardiogram is unavailable or uninterpretable, providing the patient has not undergone subsequent surgery after attempted clip.|At discharge (2.4 ± 2.4 days)|||participants|||Number
656692|NCT01931956|Secondary|Major Adverse Events in Patients Over 75 Years of Age|Defined as the occurrence of an MAE in patients over 75 years of age.|12 Months|"CU Arm:
There are 27 patients >75 years old in the CU arm. Safety data was reported on 26 patients.
EU Arm:
There are 5 patients >75 years old in the EU arm."||participants|||Number
656693|NCT01931956|Secondary|Major Adverse Events (MAE) in Patients Over 75 Years of Age|Defined as the occurrence of an MAE in patients over 75 years of age.|30 days|"CU Arm:
There are 27 patients >75 years old in the CU arm. Safety data was reported on 26 patients.
EU Arm:
There are 5 patients >75 years old in the EU arm."||participants|||Number
656694|NCT01931956|Secondary|Clinically Significant Atrial Septal Defect (ASD)|Defined as the occurrence of clinically significant Atrial Septal Defect (ASD) occurring as a result of the endovascular procedure that requires intervention.|12 months|||participants|||Number
656695|NCT01931956|Secondary|Clinically Significant Atrial Septal Defect (ASD)|Defined as the occurrence of clinically significant Atrial Septal Defect (ASD) occurring as a result of the endovascular procedure that requires intervention.|30 days|||participants|||Number
656696|NCT01931956|Secondary|Serious Adverse Events|The definition of a serious adverse event is an event that is fatal or life threatening, results in persistent or significant disability, requires intervention to prevent permanent impairment/damage, or an event that results in congenital anomaly, malignancy, hospital admission or prolongation of hospitalization.|12 months|||participants|||Number
656697|NCT01931956|Secondary|Serious Adverse Events|The definition of a serious adverse event is an event that is fatal or life threatening, results in persistent or significant disability, requires intervention to prevent permanent impairment/damage, or an event that results in congenital anomaly, malignancy, hospital admission or prolongation of hospitalization.|30 days|||participants|||Number
656698|NCT01931956|Primary|12-Month Efficacy|Defined as freedom from: Surgery for Mitral Regurgitation (MR) or Valve Dysfunction, death, and MR > 2+ (moderate to severe (3+) or severe MR (4+)).|12 months|In CU arm of total 59 participants, analysis population included 45 participants due to withdrawals (n=2), patients with missing/non-readable echo core lab MR severity assessment at 1 year (n=9), and patients with missed 1 year visit (n=3). Where as, in EU arm 6 subjects were analyzed as 1 patient missed-visit at 1 year.||participants|||Number
656699|NCT01931956|Primary|Major Adverse Events|A combined clinical endpoint of death, myocardial infarction (MI), re-operation for failed surgical repair or replacement, non-elective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, GI complication requiring surgery, new onset of permanent atrial fibrillation, septicemia and transfusion of 2 or more units of blood.|12 months|||participants|||Number
656700|NCT01931956|Primary|Major Adverse Events|A combined clinical endpoint of death, myocardial infarction (MI), re-operation for failed surgical repair or replacement, non-elective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, GI complication requiring surgery, new onset of permanent atrial fibrillation, septicemia and transfusion of 2 or more units of blood.|30 days|||participants|||Number
656701|NCT01931878|Secondary|Number of Patients Whose Patient Global Impression of Change (PGIC) Moderately or Much Improved|"The PGIC is a 7 point scale that requires the clinician to assess how much the patient's pain has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as:
No change (or condition has gotten worse) (1) Almost the same, hardly any change at all (2) A little better, but no noticeable change (3) Somewhat better, but the change has not made any real difference (4) Moderately better, and a slight but noticeable change (5) Better and a definite improvement that has made a real and worthwhile difference (6) A great deal better and a considerable improvement that has made all the difference (7)improved
This outcome is number of patients who chose a 5 or above on the PGIC 6 weeks after treatment."|6 weeks|||participants|||Number
656702|NCT01931878|Other Pre-specified|Patients With Pain on Visual Analog Scale <4|The Visual Analog Scale (VAS) consists of a line which represents the level of pain in 10 cms. The subject is required to make this line to show where your pain level is on this line (for example, at the 7cm mark). A higher score is associated with a higher level of pain. Number of patients showing a pain score of <4.|6 weeks|||participants|||Number
656705|NCT01931865|Secondary|Patients Who Show Improvement in American Pain Association Questionnaire|This quality of life scale consists of 10 questions regarding how pain affects your quality of life.|12 weeks|Advanced cancer patients||participants|||Number
656707|NCT01931839|Secondary|Part A Observation Cohort: Number of Participants With Serious Adverse Events (SAEs)|AE: as any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. AE includes serious as well as non-serious AEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, In-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event.|up to 2 years|Safety Set (study 105) included all participants who were enrolled in Part A Observation Cohort.||participants|||Number
656708|NCT01931839|Secondary|Part B Treatment Cohort: Percentage of Participants With Response Based on Relative Change in Percent Predicted FEV1 From Baseline|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, race, and height). Percentage of participants with at least 5% relative change in percent predicted FEV1 from Baseline were reported. Analysis was performed using baseline of Cohort 4 of previous study VX09-809-102 (NCT01225211) for Arm 6 and 7. As per planned analysis, endpoint evaluation included subjects from the parent study VX09-809-102 as well.|Baseline (Study 102), Day 15, Week 8, 16, 24, 36, 48, 60, 72 (Study 105)|FAS (Study 102) was used for Arm 6 and 7, and included all participants randomized in the cohort 4 of study 102 and dosed.||percentage of participants||95% Confidence Interval|Number
656709|NCT01931839|Secondary|Part A Treatment Cohort: Percentage of Participants With Response Based on Relative Change in Percent Predicted FEV1 From Baseline|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, race, and height). Percentage of participants with at least 5% and 10% relative change in percent predicted FEV1 from baseline were reported. Analysis was performed using baseline of the previous study VX12-809-103 (NCT01807923) and Study VX12-809-104 (NCT01807949) for Arm 1 and 3. Analysis was performed using baseline of the current study VX12-809-105 (NCT01931839) for Arm 2 and 4. As per planned analysis, endpoint evaluation included subjects from the parent study VX12-809-103 and VX12-809-104 as well for cumulative study period.|Baseline (Study 103/104/105); Day 15, Week 8, 16, 24, 36, 48, 60, 72, 84, 96 (Study 105)|FAS (Study 103/104) was used for Arm 1 and 3, and included all participants randomized in the previous studies and dosed. FAS (Study 105) was used for Arm 2 and 4, and included all participants randomized in the Part A Treatment Cohort and dosed in current study 105.||percentage of participants||95% Confidence Interval|Number
656710|NCT01931839|Secondary|Part A Treatment Cohort: Percentage of Participants With at Least 1 Pulmonary Exacerbation|Pulmonary exacerbation was defined as the treatment with new or changed antibiotic therapy (intravenous, inhaled, or oral) for greater than or equal to 4 sinopulmonary signs/symptoms. Analysis was performed for the Cumulative Study Period for Arm 1 and 3, and for the current study period (Study 105) for Arm 2 and 4. As per planned analysis, endpoint evaluation included subjects from the parent study VX12-809-103 and VX12-809-104 as well for cumulative study period.|Baseline (Study 103/104) up to Week 100 (Study 105) for Arm 1 and 3 (Cumulative study period); Baseline (Study 105) up to Week 100 (Study 105) for Arm 2 and 4 (current study period)|FAS (Study 103/104) was used for Arm 1 and 3, and included all participants randomized in the previous studies and dosed. FAS (Study 105) was used for Arm 2 and 4, and included all participants randomized in the Part A Treatment Cohort and dosed in current study 105.||percentage of participants||95% Confidence Interval|Number
656711|NCT01931839|Secondary|Part A Treatment Cohort: Time-to-First Pulmonary Exacerbation|Time-to-first pulmonary exacerbation was analyzed using the Kaplan-Meier estimates. Pulmonary exacerbation was defined as the treatment with new or changed antibiotic therapy (intravenous, inhaled, or oral) for greater than or equal to 4 sinopulmonary signs/symptoms. Analysis was performed for the Cumulative Study Period for Arm 1 and 3, and for the current study period (Study 105) for Arm 2 and 4. As per planned analysis, endpoint evaluation included subjects from the parent study VX12-809-103 and VX12-809-104 as well for cumulative study period.|Baseline (Study 103/104) up to Week 100 (Study 105) for Arm 1 and 3 (Cumulative study period); Baseline (Study 105) up to Week 100 (Study 105) for Arm 2 and 4 (current study period)|FAS (Study 103/104) was used for Arm 1 and 3, and included all participants randomized in the previous studies and dosed. FAS (Study 105) was used for Arm 2 and 4, and included all participants randomized in the Part A Treatment Cohort and dosed in current study 105.||days||Inter-Quartile Range|Median
656712|NCT01931839|Secondary|Part B Treatment Cohort: Absolute Change From Baseline in Body Weight at Day 15, Week 8, 16, 24, 36, 48, 60 and 72|Analysis was performed using baseline of Cohort 4 of previous study VX09-809-102 (NCT01225211) for Arm 6 and 7.|Baseline (Study 102), Day 15, Week 8, 16, 24, 36, 48, 60, 72 (Study 105)|FAS (study 105) included all participants randomized in the Part B Treatment Cohort and dosed. Here, ‘Number Analyzed’ = those participants who were evaluable at the specified time points for each arm, respectively.||kg||Standard Deviation|Mean
656713|NCT01931839|Secondary|Part A Treatment Cohort: Absolute Change From Baseline in Body Weight at Day 15, Week 8, 16, 24, 36, 48, 60 and 72|Analysis was performed using baseline of the previous study VX12-809-103 (NCT01807923) and Study VX12-809-104 (NCT01807949) for Arm 1 and 3. Analysis was performed using baseline of the current study VX12-809-105 (NCT01931839) for Arm 2 and 4.|Baseline (Study 103/104/105), Day 15, Week 8, 16, 24, 36, 48, 60, 72 (Study 105)|FAS study 105 (NCT01931839) included all participants randomized in the Part A Treatment Cohort and dosed. Here, ‘Number of participants analyzed’ = those participants who were evaluable for this endpoint and ‘Number Analyzed’ = those participants who were evaluable at the specified time points for each arm, respectively.||kilograms (kg)||Standard Deviation|Mean
656729|NCT01931709|Secondary|Percent Change in Tumor Metabolism / Perfusion Ratio (MRFDG/K1) Between Mid-therapy and Pre-therapy FDG PET Scans and Its Association With Pathologic Response|Percent change in tumor metabolism / perfusion ratio between pre-therapy and mid-therapy FDG PET scans as represented by the PET measure MRFDG/K1 (parametric) % change: (Mid-Pre)/Pre, compared between groups of patients who did or did not achieve favorable pathologic response.|Baseline to up to 12 weeks (mid-therapy)|"Three participants had to be excluded from this analysis:
mid-therapy PET images got lost due to a technical error;
pre-therapy scanning procedure had 40 seconds delayed start, preventing the modeling of parametric outcomes;
pathologic response could not be evaluated due to a metastatic disease progression prior to surgery."||percent change||Full Range|Median
656714|NCT01931839|Secondary|Part A Treatment Cohort: Absolute Change From Baseline in BMI Z-score at Day 15, Week 8, 16, 24, 36, 48, 60 and 72|z-score is a statistical measure to evaluate how a single data point compares to a standard. It describes whether a mean was above or below the standard and how unusual the measurement is with range from -infinity to +infinity; 0: same mean, >0: a greater mean, and <0: a lesser mean than the standard. BMI-for-age z-score was calculated by using centers for disease control and prevention (CDC) growth charts for the pediatric population. Analysis was performed using baseline of the previous study VX12-809-103 (NCT01807923) and Study VX12-809-104 (NCT01807949) for Arm 1 and 3. Analysis was performed using baseline of the current study VX12-809-105 (NCT01931839) for Arm 2 and 4.|Baseline (Study 103/104/105), Day 15, Week 8, 16, 24, 36, 48, 60, 72 (Study 105)|FAS study 105 (NCT01931839) included all participants randomized in the Part A Treatment Cohort and dosed. Here, ‘Number of participants analyzed’ = those participants who were evaluable for this endpoint and ‘Number Analyzed’ = those participants who were evaluable at the specified time points for each arm, respectively.||z-score||Standard Error|Least Squares Mean
656715|NCT01931839|Secondary|Part B Treatment Cohort: Absolute Change From Baseline in CFQ-R Respiratory Domain Score at Day 15, Week 8, 16, 24, 48 and 72|The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), the scaled score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life. Analysis was performed using baseline of Cohort 4 of previous study VX09-809-102 (NCT01225211) for Arm 6 and 7.|Baseline (Study 102 Study), Day 15, Week 8, 16, 24, 48, 72 (Study 105)|FAS (study 105) included all participants randomized in the Part B Treatment Cohort and dosed. Here, ‘Number of participants analyzed’ = those participants who were evaluable for this endpoint and ‘Number Analyzed’ = those participants who were evaluable at the specified time points for each arm, respectively.||units on a scale||Standard Deviation|Mean
656716|NCT01931839|Secondary|Part A Treatment Cohort: Absolute Change From Baseline in Cystic Fibrosis Questionnaire – Revised (CFQ-R) Respiratory Domain Score at Day 15, Week 8, 16, 24, 48 and 72|The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), the scaled score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life. Analysis was performed using baseline of the previous study VX12-809-103 (NCT01807923) and Study VX12-809-104 (NCT01807949) for Arm 1 and 3. Analysis was performed using baseline of the current study VX12-809-105 (NCT01931839) for Arm 2 and 4.|Baseline (Study 103/104/105), Day 15, Week 8, 16, 24, 48, 72 (Study 105)|FAS study 105 (NCT01931839) included all participants randomized in the Part A Treatment Cohort and dosed. Here, ‘Number of participants analyzed’ = those participants who were evaluable for this endpoint and ‘Number Analyzed’ = those participants who were evaluable at the specified time points for each arm, respectively.||units on a scale||Standard Error|Least Squares Mean
656717|NCT01931839|Secondary|Part A Treatment Cohort: Number of Pulmonary Exacerbations Events Per Patient-Year|Pulmonary exacerbation was defined as the treatment with new or changed antibiotic therapy (intravenous, inhaled, or oral) for greater than or equal to 4 sinopulmonary signs/symptoms. The number of events per patient year were reported, where patient years = total number of days on study/336. Analysis includes all events in the Cumulative Study Period for Arm 1 and 3, and all events in the Current Study period (Study 105) for Arm 2 and 4. As per planned analysis, endpoint evaluation included subjects from the parent study VX12-809-103 and VX12-809-104 as well for cumulative study period.|Baseline (Study 103/104) up to Week 100 (Study 105) for Arm 1 and 3 (Cumulative study period); Baseline (Study 105) up to Week 100 (Study 105) for Arm 2 and 4 (current study period)|FAS (Study 103/104) was used for Arm 1 & 3, & included all participants randomized in previous studies & dosed. FAS (Study 105) was used for Arm 2 & 4, & included all participants randomized in Part A Treatment Cohort & dosed in current study 105. ‘Number Analyzed’=those participants who were evaluable at specified time points for each arm.||events per patient year||95% Confidence Interval|Number
656718|NCT01931839|Secondary|Part B Treatment Cohort: Absolute Change From Baseline in BMI at Day 15, Week 8, 16, 24, 36, 48, 60 and 72|BMI = (Weight [in kg]) divided by (Stature [in meters]) ^2. Analysis was performed using baseline of Cohort 4 of previous study VX09-809-102 (NCT01225211) for Arm 6 and 7.|Baseline (Study 102), Day 15, Week 8, 16, 24, 36, 48, 60 , 72 (Study 105)|FAS (study 105) included all participants randomized in the Part B Treatment Cohort and dosed. Here, ‘Number Analyzed’ = those participants who were evaluable at the specified time points for each arm, respectively.||kg/m^2||Standard Deviation|Mean
656719|NCT01931839|Secondary|Part A Treatment Cohort: Absolute Change From Baseline in Body Mass Index (BMI) at Day 15, Week 8, 16, 24, 36, 48, 60 and 72|BMI = (Weight in kilogram [kg]) divided by (Stature in meters [m]) ^2. Analysis was performed using baseline of the previous study VX12-809-103 (NCT01807923) and Study VX12-809-104 (NCT01807949) for Arm 1 and 3. Analysis was performed using baseline of the current study VX12-809-105 (NCT01931839) for Arm 2 and 4.|Baseline (Study 103/104/105), Day 15, Week 8, 16, 24, 36, 48, 60 , 72 (Study 105)|FAS study 105 (NCT01931839) included all participants randomized in the Part A Treatment Cohort and dosed. Here, ‘Number of participants analyzed’ = those participants who were evaluable for this endpoint and ‘Number Analyzed’ = those participants who were evaluable at the specified time points for each arm, respectively.||Kilogram per square meter (kg/m^2)||Standard Error|Least Squares Mean
656720|NCT01931839|Secondary|Part B Treatment Cohort: Relative Change From Baseline in Percent Predicted FEV1 at Day 15, Week 8, 16, 24, 36, 48, 60 and 72|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, race, and height). The Hankinson standard was used for male participants 18 years and older and female participants 16 years and older. The Wang standard was used for male participants aged 12 to 17 years and for female participants aged 12 to 15 years. Analysis was performed using baseline of Cohort 4 of previous study VX09-809-102 (NCT01225211) for Arm 6 and 7.|Baseline (Study 102), Day 15, Week 8, 16, 24, 36, 48, 60 , 72 (Study 105)|FAS (study 105) included all participants randomized in the Part B Treatment Cohort and dosed. Here, ‘Number of participants analyzed’ = those participants who were evaluable for this endpoint and ‘Number Analyzed’ = those participants who were evaluable at the specified time points for each arm, respectively.||percent change||Standard Deviation|Mean
658019|NCT01910389|Secondary|Frequency of HF Hospitalizations||Randomization through each subject's last semi-annual visit, up to a maximum of 3 years per subject|Trial was terminated early. Data for outcome not obtained.|||||
656721|NCT01931839|Secondary|Part A Treatment Cohort: Relative Change From Baseline in Percent Predicted FEV1 at Day 15, Week 8, 16, 24, 36, 48, 60 and 72|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, race, and height). The Hankinson standard was used for male participants 18 years and older and female participants 16 years and older. The Wang standard was used for male participants aged 12 to 17 years and for female participants aged 12 to 15 years. Analysis was performed using baseline of the previous study VX12-809-103 (NCT01807923) and Study VX12-809-104 (NCT01807949) for Arm 1 and 3. Analysis was performed using baseline of the current study VX12-809-105 (NCT01931839) for Arm 2 and 4.|Baseline (Study 103/104/105), Day 15, Week 8, 16, 24, 36, 48, 60 , 72 (Study 105)|FAS study 105 (NCT01931839) included all participants randomized in the Part A Treatment Cohort and dosed. Here, ‘Number of participants analyzed’ = those participants who were evaluable for this endpoint and ‘Number Analyzed’ = those participants who were evaluable at the specified time points for each arm, respectively.||percent change||Standard Error|Least Squares Mean
656722|NCT01931839|Secondary|Part B Treatment Cohort: Absolute Change From Baseline in Percent Predicted FEV1 at Day 15, Week 8, 16, 24, 36, 48, 60 and 72|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, race, and height). The Hankinson standard was used for male participants 18 years and older and female participants 16 years and older. The Wang standard was used for male participants aged 12 to 17 years and for female participants aged 12 to 15 years. Analysis was performed using baseline of Cohort 4 of previous study VX09-809-102 (NCT01225211) for Arm 6 and 7.|Baseline (Study 102), Day 15, Week 8, 16, 24, 36, 48, 60 , 72 (Study 105)|FAS (study 105) included all participants randomized in the Part B Treatment Cohort and dosed. Here, ‘Number of participants analyzed’ = those participants who were evaluable for this endpoint and ‘Number Analyzed’ = those participants who were evaluable at the specified time points for each arm, respectively.||percent predicted of FEV1||Standard Deviation|Mean
656723|NCT01931839|Secondary|Part A Treatment Cohort: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) At Day 15, Week 8, 16, 24, 36, 48, 60 and 72|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, race, and height). The Hankinson standard was used for male participants 18 years and older and female participants 16 years and older. The Wang standard was used for male participants aged 12 to 17 years and for female participants aged 12 to 15 years. Analysis was performed using baseline of the previous study VX12-809-103 (NCT01807923) and Study VX12-809-104 (NCT01807949) for Arm 1 and 3. Analysis was performed using baseline of the current study VX12-809-105 (NCT01931839) for Arm 2 and 4.|Baseline (Study 103/104/105); Day 15, Week 8, 16, 24, 36, 48, 60 , 72 (Study 105)|Full Analysis Set (FAS) study 105 (NCT01931839) included all participants randomized in the Part A Treatment Cohort and dosed. Here, ‘Number of participants analyzed’ = those participants who were evaluable for this endpoint and ‘Number Analyzed’ = those participants who were evaluable at the specified time points for each arm, respectively.||percent predicted of FEV1||Standard Error|Least Squares Mean
656724|NCT01931839|Primary|Part B Treatment Cohort: Number of Participants With Treatment-Emergent AEs and SAEs|AE: as any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after informed consent form is signed. AE includes serious as well as non-serious AEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, In-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Any AE that increased in severity or newly developed at or after initial dosing of study drug was considered treatment-emergent.|Day 1 up to Week 105 (Study 105)|Safety Set (study 105) included all participants in the Treatment Cohort Part B who were exposed to any amount of study drug.||participants|||Number
656725|NCT01931839|Primary|Part A Treatment Cohort: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: as any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after informed consent form is signed. AE includes serious as well as non-serious AEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, In-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Any AE that increased in severity or newly developed at or after initial dosing of study drug was considered treatment-emergent.|Day 1 up to Week 105 (Study 105)|Safety Set (study 105) included all participants in Treatment Cohort Part A who were exposed to any amount of study drug.||participants|||Number
656726|NCT01931709|Secondary|Percent Change in DCE-MRI Peak Percent Enhancement (Peak PE) Between Mid-therapy and Pre-therapy Breast MRI Scans and Its Association With Pathologic Response|Percent change in tumor enhancement between pre-therapy and mid-therapy DCE-MRI scans as represented by the MRI measure Peak PE % change: (Mid-Pre)/Pre, compared between groups of patients who did or did not achieve favorable pathologic response.|Baseline to up to 12 weeks (mid-therapy)|"One participant had to be excluded from this analysis:
[1] pathologic response could not be evaluated due to a metastatic disease progression prior to surgery."||percent change||Full Range|Median
656727|NCT01931709|Secondary|Overall Survival|Will be examined using Cox proportional hazards regression.|From time of surgery until death, assessed up to 5 years||||||
656728|NCT01931709|Secondary|Time From Surgery to Breast Cancer Recurrence or Death|Will be examined using Cox proportional hazards regression.|From surgery to breast cancer recurrence or death, assessed up to 5 years||||||
656763|NCT01930487|Secondary|Change in Central Retinal Artery Blood Flow - Vascular Resistance (Ratio) - No DM|change (post-treatment - pre-treatment) in central retinal artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients without type 2 diabetes|baseline and 30 days|patients completing both study periods||ratio||Standard Error|Mean
658020|NCT01910389|Secondary|Frequency of CV Hospitalizations||Randomization through each subject's last semi-annual visit, up to a maximum of 3 years per subject|Trial was terminated early. Data for outcome not obtained.|||||
656730|NCT01931709|Secondary|Percent Change in PET K1 Between Mid-therapy and Pre-therapy FDG PET Scans and Its Association With Pathologic Response|Percent change in tumor perfusion between pre-therapy and mid-therapy FDG PET scans as represented by the PET measure K1 (parametric) % change: (Mid-Pre)/Pre, compared between groups of patients who did or did not achieve favorable pathologic response.|Baseline to up to 12 weeks (mid-therapy)|"Three participants had to be excluded from this analysis:
mid-therapy PET images got lost due to a technical error;
pre-therapy scanning procedure had 40 seconds delayed start, preventing the modeling of parametric outcomes;
pathologic response could not be evaluated due to a metastatic disease progression prior to surgery."||percent change||Full Range|Median
656731|NCT01931709|Primary|Number of Participants With Favorable Pathologic Response at Surgery|"The primary clinical endpoint is dichotomous (yes/no) - Has patient achieved favorable microscopic pathologic response at surgery? This favorable pathologic response is defined as:
No evidence of microscopic invasive tumor at the primary tumor site and in regional axillary lymph nodes = Residual Cancer Burden class 0 (RCB 0)
Minimal invasive residual disease at primary tumor site and/or in regional axillary lymph nodes = Residual Cancer Burden class I (RCB I)"|At time of surgery|||Participants|||Count of Participants
656732|NCT01931527|Secondary|Determine the Effect of Reducing Uric Acid on Oxidative Status|Uric acid will be reduced to 0 with a 30 minute infusion of a uricase (Elitek, Sanofi-Aventis). Systemic (urinary isoprostanes) and skeletal muscle (carbonylated protein ratio) oxidative stress and total antioxidant capacity (plasma and saliva TRAP and FRAP) will be measured in obese subjects with high uric acid before and after uric acid reduction.|12 hours after reducing uric acid|||ng/mg||Standard Error|Mean
656733|NCT01931527|Primary|Determine the Effect of Reducing Uric Acid on Insulin Sensitivity|Uric acid will be reduced to 0 with a 30 minute infusion of a uricase (Elitek, Sanofi-Aventis). A hyperinsulinemic-euglycemic clamp procedure in conjunction with stable isotope glucose tracer infusion will be used to measure skeletal muscle insulin sensitivity in obese subjects with high uric acid before and after uric acid reduction.|12 hours after reducing uric acid|||% incr. in insulin-mediated gluc. uptake||Standard Error|Mean
656734|NCT01931475|Secondary|Percentage of Participants With Response to Treatment on Patient Global Impression-Improvement (PGI-I) at Endpoint|PGI-I measures the participant's perception of improvement at the time of assessment compared with the start of treatment. Scores ranged from 1 (very much better) to 7 (very much worse). Response to treatment is defined by endpoint PGI rating of either “much better” or “very much better”.The last observation carried forward (LOCF) method will be used for these analyses.|Week 13|All participants who were randomized and had a baseline and at least 1 post-baseline observation.||percentage of participants|||Number
656735|NCT01931475|Secondary|Percentage of Participants With Reduction of ≥30% and ≥50% in BPI Average Pain Score|Pain severity was measured using an 11 point BPI scale from 0 (no pain) to 10 (worst pain) to determine average pain in the past 24 hours (average pain). A 30% (or 50%) improvement was defined as a ≥30% (or ≥50%) reduction in BPI pain severity from baseline to endpoint. Percentage of participants = (number of participants with ≥30% or ≥50% pain reduction / total number of participants in treatment group) * 100.The last observation carried forward (LOCF) method will be used for these analyses.|Week 13|All participants who were randomized and had a baseline and at least 1 post-baseline observation.||percentage of participants|||Number
656736|NCT01931475|Secondary|Change in Brief Pain Inventory (BPI) Average Pain Intensity Scores, Hospital Anxiety and Depression Scale (HADS) Depression Subscale (HADS-D) and HADS Anxiety Subscale (HADS-A)|Evaluation on whether the change in BPI average pain intensity scores is a direct analgesic effect of duloxetine and is independent of treatment effect on mood, as measured by Hospital Anxiety and Depression Scale (HADS) depression subscale (HADS-D), or anxiety as measured by HADS anxiety subscale (HADS-A). Path analysis for the direct analgesic effect was used to test the null hypothesis that the change in BPI average pain severity depends on the improvement of HADS-D or HADS-A, versus the alternative that the improvement in BPI average pain severity is due to a direct analgesic effect of the treatment and not dependent upon the improvement in depression and anxiety symptoms.|Baseline, Week 13|All participants who were randomized and had a baseline and at least 1 post-baseline observation.||units on a scale||Standard Deviation|Mean
656737|NCT01931475|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale-Depression (HADS-D) or HADS-Anxiety (HADS-A) Subscale Scores|HADS is a 14-item questionnaire with 2 subscales: anxiety and depression. Each item was rated on a 4-point scale [0 (low level of anxiety or depression) to 3 (high level of anxiety or depression)], giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale were considered to be a 'significant' case of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.' Mean was calculated using analysis of covariance (ANCOVA) and adjusted for treatment, pooled investigator, and baseline score. The last observation carried forward (LOCF) method will be used for these analyses.|Baseline, Week 13|All participants who were randomized and had a baseline and at least 1 post-baseline observation.||units on a scale||Standard Error|Mean
656738|NCT01931475|Secondary|Change From Baseline in Brief Pain Inventory (BPI) Interference|BPI Interference Average Score is a self-reported scale that measures interference of pain on average of the 7 questions assessing the interference of pain for general activity, mood, walking ability, normal work, relations with other people,sleep, and enjoyment of life.The average Interference scores ranged from 0 to 10. General activity, mood,walking ability, normal work,relations with other people, sleep and enjoyment of life is each is a self-reported scale that measures the interference of pain in the past 24 hours on general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life.The Interference scores ranged from 0 (does not interfere) to 10 (completely interferes).Least squares (LS) mean was calculated using mixed model repeating measures (MMRM) and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction.|Baseline, Week 13|All participants who were randomized and had a baseline and at least 1 post-baseline observation.||units on a scale||Standard Error|Least Squares Mean
656764|NCT01930487|Secondary|Change in Central Retinal Artery Blood Flow - Vascular Resistance (Ratio) - DM|change (post-treatment - pre-treatment) in central retinal artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients with type 2 diabetes|baseline and 30 days|patients completing both study periods||ratio||Standard Error|Mean
657646|NCT01918306|Other Pre-specified|Correlation of the Presence of PIK3CA Mutations in the Tumor With Time to Tumor Progression.|Examining tumor tissue for PI3K mutations and correlating this statistically with clinical outcomes including time to tumor progression.|2 years||||||
656739|NCT01931475|Secondary|Change From Baseline in Brief Pain Inventory (BPI) Severity|BPI Severity of Worst Pain is self-reported scale that measures the severity of pain based on the worst pain experienced during the past 24-hours. The severity scores ranged from 0 (no pain) to 10 (pain as severe as you can imagine). BPI Severity of Least Pain is a self-reported scale that measures the severity of pain based on the least pain experienced during the past 24-hours. The severity scores ranged from 0 (no pain) to 10 (pain as severe as you can imagine). BPI Severity of Right Now Pain is a self-reported scale that measures the severity of pain based on the pain right now. The severity scores ranged from 0 (no pain) to 10 (pain as severe as you can imagine). Least squares (LS) mean was calculated using mixed model repeating measures (MMRM) and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction.|Baseline, Week 13|All participants who were randomized and had a baseline and at least 1 post-baseline observation.||units on a scale||Standard Error|Least Squares Mean
656740|NCT01931475|Secondary|Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score|CGI-S measures severity of illness at the time of assessment compared with start of treatment with scores ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Least squares (LS) mean was calculated using mixed model repeating measures (MMRM) and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction.|Baseline,13 Weeks|All participants who were randomized and had a baseline and at least 1 post-baseline observation.||units on a scale||Standard Error|Least Squares Mean
656741|NCT01931475|Secondary|Change From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Total and Subscale Scores|WOMAC consists of 24 items divided into 3 subscales:Pain(5 items):during walking,using stairs,in bed,sitting or lying,and standing Stiffness;(2 items):after first waking and later in the day Physical Function;(17 items):stair use,rising from sitting, standing, bending,walking,getting in/out of a car,shopping,putting on/taking off socks,rising from bed,lying in bed,getting in/out of bath,sitting,getting on/off toilet,heavy household duties,light household duties.Each question is answered using a 5-point Likert scale(0 to 4).Pain subscale has a range of scores of 0(none) to 20(extreme).Stiffness subscale has a range of scores of 0(none) to 8(extreme).Physical function subscale has a range of scores of 0(none) to 68(extreme).Total score ranges from 0(none) to 96(extreme).Least squares(LS) mean was calculated using analysis of covariance(ANCOVA) and adjusted for treatment, pooled investigator,and baseline score.Last observation carried forward (LOCF) method was be used for these analyses.|Baseline, Week 13|All participants who were randomized and had a baseline and at least 1 post-baseline observation.||units on a scale||Standard Error|Least Squares Mean
656742|NCT01931475|Secondary|Patient Global Impressions of Improvement (PGI-I) Score|PGI-I measures a participant's perception of improvement at the time of assessment compared with the start of treatment. Score ranges from 1 (very much better) to 7 (very much worse). Least squares (LS) mean was calculated using mixed model repeating measures (MMRM) and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction.|13 Weeks|All participants who were randomized and had a baseline and at least 1 post-baseline observation.||units on a scale||Standard Error|Least Squares Mean
656743|NCT01931475|Primary|Change From Baseline in the Brief Pain Inventory (BPI) 24-hour Average Pain Score|BPI is a self-reported scale that measures the severity of pain based on the average pain during the past 24-hours. The severity scores ranged from 0 (no pain) to 10 (pain as severe as you can imagine). Least squares (LS) mean was calculated using mixed model repeating measures (MMRM) and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction.|Baseline, Week 13|All participants who were randomized and had a baseline and at least 1 post-baseline observation.||units on a scale||Standard Error|Least Squares Mean
656744|NCT01931397|Other Pre-specified|Changes in Adherence Parameters to Home DBS Method|"We will calculate the percent of returned DBS filter papers to OHSU on a monthly basis utilized for TAC and Cr analysis.
we calculated the percentage as the number of DBS that were actually received divided by the total number of DBS expected to be received from participants over the study time period"|At baseline then every 3 months for 12 months|The number of DBS cards expected to be received by those 28 patients were 279 DBS samples.||percentage of DBS cards|Total number of DBS cards||Number
656745|NCT01931397|Other Pre-specified|Mean Tacrolimus Blood Levels Measured by DBS Over Study Period According to Age|Mean Tacrolimus blood levels obtained by DBS in each patient over their time in the study in children who are 12 years and over versus those less than 12 years of age.|up to 12 months|We analyzed a total of 216 dried blood spots for Tacrolimus blood levels measured in ng/ml||ng/ml|number of blood samples|Standard Deviation|Mean
656746|NCT01931397|Secondary|Percentage of Families Preferring DBS Method|"The % of families who anticipated preference of DBS method over intravenous blood draws at the time of enrollment and then the % of those who preferred DBS at end of study period (12 months).
Families include parents/caregivers and participants who are over 10 years of age were asked to fill in the preference scale separately.
Preference for DBS Testing was measured using a Visual Analog Scale (VAS) on which a zero was equivalent to no preference for DBS versus laboratory-based monitoring and on which positive numbers indicated greater preference for DBS (up to +72) and negative scores indicated a greater preference for laboratory-based monitoring (down to -72)."|At baseline and then at 12 months|25 families participated in the preference survey at time of enrollment and only 15 families completed the survey at the end of the study period (12 months).||% of families|||Number
656747|NCT01931397|Primary|Variability of Tacrolimus Blood Levels Measured by DBS Over Time|Mean standard deviation scores for Tacrolimus blood levels obtained by DBS for each patient over time.|12 months|9 participants were excluded from final analysis because they submitted two or less evaluable blood samples. A total of 216 DBS samples were received during the study||ng/ml|blood samples|Standard Deviation|Mean
656748|NCT01931150|Primary|Number of Patients in Which the PI Observed a Notable Difference in the Number of Lesions|Change from Baseline in the Number of Lesions at 28 days|28 days|||participants|||Number
656765|NCT01930487|Secondary|Change in Ophthalmic Artery Blood Flow - Vascular Resistance (Ratio) - No DM|change (post-treatment - pre-treatment) in ophthalmic artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients without type 2 diabetes|baseline and 30 days|patients completing both study periods||ratio||Standard Error|Mean
658088|NCT01910064|Primary|Local Tolerability (Stinging/Burning)|Highest Severity of Local Tolerability Scores Worse Than Baseline|12 months|||subjects|||Number
656749|NCT01930890|Primary|Number of Participants Who Discontinued Study Treatment or Withdrew From Study Due to an AE|AEs with a start date on or after the first dose date in study 211LE202. AE: any untoward medical occurrence that does not necessarily have a causal relationship with this treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the subject at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect. An SAE may also be any other medically important event that, in the opinion of the Investigator, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above.|Up to Week 108|The safety population was defined as all participants who received at least 1 dose of study treatment (3 or 20 mg/kg BIIB023 in Study 211LE202).||participants|||Number
656750|NCT01930890|Primary|Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)|AEs with a start date on or after the first dose date in study 211LE202. AE: any untoward medical occurrence that does not necessarily have a causal relationship with this treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the subject at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect. An SAE may also be any other medically important event that, in the opinion of the Investigator, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above.|Up to Week 108|The safety population was defined as all participants who received at least 1 dose of study treatment (3 or 20 mg/kg BIIB023 in Study 211LE202).||participants|||Number
656751|NCT01930799|Secondary|Percentage of Patients Who Agree/Completely Agree With Each Question on the Patient Post-Video Questionnaire|The Patient Post-Video Questionnaire was based on 5 individual questions assessing the patient’s perception of the utility of the video in helping them 1) understand how MS can affect the bladder, 2) how to recognize bladder symptoms, 3) understand various treatment options, 4) understand self-help strategies, and 5) better manage their bladder problems. Percentages represent the proportion of patients who “agree/completely agree” with each question. Patients viewed the video at the Baseline visit, then completed the Patient Post-Video Questionnaire immediately after viewing the video at the Baseline visit.|Baseline|Eligible enrolled subjects||Percentage of Patients|||Number
656752|NCT01930799|Primary|Change From Baseline in the King's Health Questionnaire (KHQ) Domain Scores|The KHQ is a valid and reliable patient reported outcome measure for the assessment of quality of life in subjects with urinary incontinence that contains the following 8 domains: general health perception, incontinence impact, role limitations, physical limitations, social limitations, personal relations, emotions, sleep/energy, and severity measures. The KHQ domain scores are based on a scale of 0-100, with a lower score indicating less severity. Decreases in KHQ domain scores indicate an improvement in quality of life and increases in KHQ domain scores indicate a worsening in quality of life.|Baseline, Month 6|Eligible and enrolled subjects who completed the Month 6 visit||Scores on a Scale||Standard Deviation|Mean
656753|NCT01930487|Secondary|Change in Inferior Retinal Capillary Blood Flow (% Zero Pixels) - No DM|change (post-treatment - pre-treatment) in inferior retinal capillary blood flow (% zero pixels or % avascular tissue) using Heidelberg Retinal Flowmeter (HRF) in patients without type 2 diabetes|baseline and 30 days|patients completing both study periods||% zero pixels||Standard Error|Mean
656754|NCT01930487|Secondary|Change in Inferior Retinal Capillary Blood Flow (% Zero Pixels) - DM|change (post-treatment - pre-treatment) in inferior retinal capillary blood flow (% zero pixels or % avascular tissue) using Heidelberg Retinal Flowmeter (HRF) in patients with type 2 diabetes|baseline and 30 days|patients completing both study periods||% zero pixels||Standard Error|Mean
656755|NCT01930487|Secondary|Change in Superior Retinal Capillary Blood Flow (% Zero Pixels) - No DM|change (post-treatment - pre-treatment) in superior retinal capillary blood flow (% zero pixels or % avascular tissue) using Heidelberg Retinal Flowmeter (HRF) in patients without type 2 diabetes|baseline and 30 days|patients completing both study periods||% zero pixels||Standard Error|Mean
656756|NCT01930487|Secondary|Change in Superior Retinal Capillary Blood Flow (% Zero Pixels) - DM|change (post-treatment - pre-treatment) in superior retinal capillary blood flow (% zero pixels or % avascular tissue) using Heidelberg Retinal Flowmeter (HRF) in patients with type 2 diabetes|baseline and 30 days|patients completing both study periods||% zero pixels||Standard Error|Mean
656757|NCT01930487|Secondary|Change in Ocular Perfusion Pressure - No DM|change (post-treatment - pre-treatment) in Ocular perfusion pressure in patients without type 2 diabetes|baseline and 30 days|patients completing both study periods||mm Hg||Standard Error|Mean
656758|NCT01930487|Secondary|Change in Ocular Perfusion Pressure - DM|change (post-treatment - pre-treatment) in Ocular perfusion pressure in patients with type 2 diabetes|baseline and 30 days|patients completing both study periods||mm Hg||Standard Error|Mean
656759|NCT01930487|Secondary|Change in Temporal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - No DM|change (post-treatment - pre-treatment) in temporal posterior artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients without type 2 diabetes|baseline and 30 days|patients completing both study periods||ratio||Standard Error|Mean
656760|NCT01930487|Secondary|Change in Temporal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - DM|change (post-treatment - pre-treatment) in temporal posterior artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients with type 2 diabetes|baseline and 30 days|patients completing both study periods||ratio||Standard Error|Mean
656761|NCT01930487|Secondary|Change in Nasal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - No DM|change (post-treatment - pre-treatment) in nasal posterior artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients without type 2 diabetes|baseline and 30 days|patients completing both study periods||ratio||Standard Error|Mean
656762|NCT01930487|Secondary|Change in Nasal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - DM|change (post-treatment - pre-treatment) in nasal posterior artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients with type 2 diabetes|baseline and 30 days|patients completing both study periods||ratio||Standard Error|Mean
657617|NCT01918371|Secondary|Percentage of Participants Switching Among Different Anti-VEGF Agents in the Study Eye|Participants who switched among the different Anti-VEGF Agents: bevacizumab, ranibizumab and aflibercept.|Up to 4 Years|All participants with data available.||percentage of participants|||Number
656767|NCT01930487|Secondary|Change in Temporal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - No DM|change (post-treatment - pre-treatment) in temporal posterior ciliary artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes|baseline and 30 days|patients completing both study periods||cm/s||Standard Error|Mean
656768|NCT01930487|Secondary|Change in Temporal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - DM|change (post-treatment - pre-treatment) in temporal posterior ciliary artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes|baseline and 30 days|patients completing both study periods||cm/s||Standard Error|Mean
656769|NCT01930487|Secondary|Change in Nasal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - No DM|change (post-treatment - pre-treatment) in nasal posterior ciliary artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes|baseline and 30 days|patients completing both study periods||cm/s||Standard Error|Mean
656770|NCT01930487|Secondary|Change in Nasal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - DM|change (post-treatment - pre-treatment) in nasal posterior ciliary artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes|baseline and 30 days|patients completing both study periods||cm/s||Standard Error|Mean
656771|NCT01930487|Secondary|Change in Central Retinal Artery End Diastolic Blood Flow Velocity (cm/s) - No DM|change (post-treatment - pre-treatment) in central retinal artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes|baseline and 30 days|patients completing both study periods||cm/s||Standard Error|Mean
656772|NCT01930487|Secondary|Change in Central Retinal Artery End Diastolic Blood Flow Velocity (cm/s) - DM|change (post-treatment - pre-treatment) in central retinal artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes|baseline and 30 days|patients completing both study periods||cm/s||Standard Error|Mean
656773|NCT01930487|Secondary|Change in Ophthalmic Artery End Diastolic Blood Flow Velocity (cm/s) - No DM|change (post-treatment - pre-treatment) in ophthalmic artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes|baseline and 30 days|patients completing both study periods||cm/s||Standard Error|Mean
656774|NCT01930487|Secondary|Change in Ophthalmic Artery End Diastolic Blood Flow Velocity (cm/s) - DM|change (post-treatment - pre-treatment) in ophthalmic artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes|baseline and 30 days|patients completing both study periods||cm/s||Standard Error|Mean
656775|NCT01930487|Secondary|Change in Temporal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM|change (post-treatment - pre-treatment) in temporal posterior ciliary artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes|baseline and 30 days|patients completing both study periods||cm/s||Standard Error|Mean
656776|NCT01930487|Secondary|Change in Temporal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - DM|change (post-treatment - pre-treatment) in temporal posterior ciliary artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes|baseline and 30 days|patients completing both study periods||cm/s||Standard Error|Mean
656777|NCT01930487|Secondary|Change in Nasal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM|change (post-treatment - pre-treatment) in nasal posterior ciliary artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes|baseline and 30 days|patients completing both study periods||cm/s||Standard Error|Mean
656778|NCT01930487|Secondary|Change in Nasal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - DM|change (post-treatment - pre-treatment) in nasal posterior ciliary artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes|baseline and 30 days|patients completing both study periods||cm/s||Standard Error|Mean
656779|NCT01930487|Secondary|Change in Central Retinal Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM|change (post-treatment - pre-treatment) in central retinal artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes|baseline and 30 days|patients completing both study periods||cm/s||Standard Error|Mean
656780|NCT01930487|Secondary|Change in Central Retinal Artery Peak Systolic Blood Flow Velocity (cm/s) - DM|change (post-treatment - pre-treatment) in central retinal artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes|baseline and 30 days|patients completing both study periods||cm/s||Standard Error|Mean
656781|NCT01930487|Secondary|Change in Ophthalmic Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM|change (post-treatment - pre-treatment) in ophthalmic artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes|baseline and 30 days|patients completing both study periods||cm/s||Standard Error|Mean
656782|NCT01930487|Secondary|Change in Ophthalmic Artery Peak Systolic Blood Flow Velocity (cm/s) - DM|change (post-treatment - pre-treatment) in ophthalmic artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes|baseline and 30 days|patients completing both study periods||cm/s||Standard Error|Mean
656783|NCT01930487|Secondary|Change in Temporal Posterior Ciliary Artery Blood Flow - Vascular Resistance (Ratio)|change (post-treatment - pre-treatment) in temporal posterior ciliary artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI)|baseline and 30 days|patients completing both study periods||ratio||Standard Error|Mean
656784|NCT01930487|Secondary|Change in Nasal Posterior Ciliary Artery Blood Flow - Vascular Resistance (Ratio)|change (post-treatment - pre-treatment) in nasal posterior ciliary artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI)|baseline and 30 days|patients completing both study periods||ratio||Standard Error|Mean
656785|NCT01930487|Secondary|Change in Central Retinal Artery Blood Flow - Vascular Resistance (Ratio)|change (post-treatment - pre-treatment) in central retinal artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI)|baseline and 30 days|patients completing both study periods||ratio||Standard Error|Mean
656786|NCT01930487|Secondary|Change in Ophthalmic Artery Blood Flow - Vascular Resistance (Ratio)|change (post-treatment - pre-treatment) in ophthalmic artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI)|baseline and 30 days|patients completing both study periods||ratio||Standard Error|Mean
656787|NCT01930487|Secondary|Change in Temporal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s)|change (post-treatment - pre-treatment) in temporal posterior ciliary artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI)|baseline and 30 days|patients completing both study periods||cm/s||Standard Error|Mean
656788|NCT01930487|Secondary|Change in Nasal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s)|change (post-treatment - pre-treatment) in nasal posterior ciliary artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI)|baseline and 30 days|patients completing both study periods||cm/s||Standard Error|Mean
656789|NCT01930487|Secondary|Change in Central Retinal Artery End Diastolic Blood Flow Velocity (cm/s)|change (post-treatment - pre-treatment) in central retinal artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI)|baseline and 30 days|patients completing both study periods||cm/s||Standard Error|Mean
656790|NCT01930487|Secondary|Change in Ophthalmic Artery End Diastolic Blood Flow Velocity (cm/s)|change (post-treatment - pre-treatment) in ophthalmic artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI)|baseline and 30 days|patients completing both study periods||cm/s||Standard Error|Mean
656791|NCT01930487|Secondary|Change in Temporal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s)|change (post-treatment - pre-treatment) in temporal posterior ciliary artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI)|baseline and 30 days|patients completing both study periods||cm/s||Standard Error|Mean
656792|NCT01930487|Secondary|Change in Nasal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s)|change (post-treatment - pre-treatment) in nasal posterior ciliary artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI)|baseline and 30 days|patients completing both study periods||cm/s||Standard Error|Mean
656793|NCT01930487|Secondary|Change in Central Retinal Artery Peak Systolic Blood Flow Velocity (cm/s)|change (post-treatment - pre-treatment) in central retinal artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI)|baseline and 30 days|patients completing both study periods||cm/s||Standard Error|Mean
656794|NCT01930487|Secondary|Change in Ophthalmic Artery Peak Systolic Blood Flow Velocity (cm/s)|change (post-treatment - pre-treatment) in ophthalmic artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI)|baseline and 30 days|patients completing both study periods||cm/s||Standard Error|Mean
656795|NCT01930487|Secondary|Change in Ocular Perfusion Pressure|change (post-treatment - pre-treatment) in ocular perfusion pressure (2/3 Mean arterial pressure - intraocular pressure)|baseline and 30 days|patients completing both study periods||mm Hg||Standard Error|Mean
656796|NCT01930487|Primary|Change in Inferior Retinal Capillary Blood Flow (% Zero Pixels)|change (post-treatment - pre-treatment) in inferior retinal capillary blood flow (% zero pixels or % avascular tissue) using Heidelberg Retinal Flowmeter (HRF)|baseline and 30 days|patients completing both study periods||% zero pixels||Standard Error|Mean
656797|NCT01930487|Primary|Change in Superior Retinal Capillary Blood Flow (% Zero Pixels)|change (post-treatment - pre-treatment) in superior retinal capillary blood flow (% zero pixels or % avascular tissue) using Heidelberg Retinal Flowmeter (HRF)|baseline and 30 days|patients completing both study periods||% zero pixels||Standard Error|Mean
656798|NCT01930435|Secondary|Rate of Hospitalization in Patients Who Use Personalized Sterile Humidification|Rate of Hospitalization in Patients Who Use Personalized Sterile Humidification, determined based on admission to hospital over active study period|during 12 weeks duration|||participants|||Number
656799|NCT01930435|Secondary|Rate of Feeding Tube Placement Among Patients Using Personalized Sterile Humidification|Feeding Tube Placement in Patients Who Use Personalized Sterile Humidification, as determined by placement of either nasogastric or gastrostomy tube. This was enumerated as the number of participants who had a feeding tube placed.|over 12 weeks duration|||participants|||Number
656800|NCT01930435|Secondary|Clinician Graded CTCAE-rated Mucositis Score Over 12 Weeks|The maximum severity of clinician rating of mucositis observed over 12 weeks, as graded on a scale ranging from 1 (minimal mucositis) to 3 (confluent mucositis) to 5 (death) using the Common Terminology Criteria for Adverse Events v 4.0|over 12 weeks duration|||units on a scale||Standard Deviation|Mean
656801|NCT01930435|Secondary|Percentage of Patients Achieving Compliance With Use of Personalized Sterile Humidification.|Compliance was pre-specified in the protocol as self-reported usage of the device at a level equal to or greater than 60% of the formal recommended usage. This cut-off at 60% represented the median of the distribution of the usage of the device among all patients. The outcome measure is the percentage of participants who reported using the device at a level equal to or greater than 60% of the total prescribed usage.|over entire 12 weeks duration|||percentage of participants|||Number
656802|NCT01930435|Primary|Mean Change in Quality of Life as Measured by the Subscale MDASI-HN Score.|The MDASI-HN assesses the severity of symptoms at their worst in the last 24 hours on a 0–10 NRS, with 0 being “not present” and 10 being “as bad as you can imagine.” There are 28 items in the MDASI-HN. There are 13 general inventory items, 6 general interference items, and the HN subscale adds 9 additional items assessing mucus in the mouth and throat, difficulty swallowing/chewing, choking/coughing, difficulty with voice/speech, skin pain/burning/rash, constipation, problems with tasting food, mouth/throat sores, and problems with teeth or gums. Scores for the subscales (general, interference, HN) are averaged so that a score is obtained from 0-10 for each subscale. The mean change in quality of life is calculated as the average scores at 6 weeks minus the average of the scores at baseline. Therefore a positive value represents a worsened quality of life and a negative value is an improvement in quality of life.|Mean value of [(MDASI-HN score at 6 weeks) - (MDASI-HN score at baseline)]|||units on a scale||95% Confidence Interval|Mean
656803|NCT01930162|Secondary|Incidence of Relapse-free Survival Within One Year|Patients are considered to have achieved relapse-free survival if they had not experienced either relapse or death (of any cause) at the end of the study.|1 year|Safety Analysis Set: The Safety analysis included all enrolled patients who were transplanted with HSC835 (any patient with a date for HSC835 transplant).||Participants|||Number
656804|NCT01930162|Secondary|Incidence of Overall Survival Within One Year|Overall survival is the proportion of patients who were alive at the end of the one year study period.|1 year|Safety Analysis Set: The Safety analysis included all enrolled patients who were transplanted with HSC835 (any patient with a date for HSC835 transplant).||Participants|||Number
658089|NCT01910064|Primary|Local Tolerability (Pruritus)|Highest Severity of Local Tolerability Scores Worse Than Baseline|12 months|||participants|||Number
656805|NCT01930162|Secondary|Incidence of Non-relapse Mortality (NRM) Within 100 Days and One Year|NRM includes all patients who died from any other cause except relapse of the underlying disease during the study duration.|1 year|Safety Analysis Set: The Safety analysis included all enrolled patients who were transplanted with HSC835 (any patient with a date for HSC835 transplant).||Participants|||Number
656806|NCT01930162|Secondary|Incidence of Neutrophil Recovery Within 42 Days|Engraftment is defined as the first of three consecutive days with ANC > 0.5 x 109/L.|42 days|Safety Analysis Set: The Safety analysis included all enrolled patients who were transplanted with HSC835 (any patient with a date for HSC835 transplant).||Participants|||Number
656807|NCT01930162|Primary|Absence of Graft Failure at Day 42|This endpoint was to study safety and tolerability of HSC835 as measured by the absence of graft failure at day 42 in excess of that currently observed with double umbilical cord blood (UCB) transplantation (DUCBT) with non-myeloablative (NMA) conditioning.|42 days|Safety Analysis Set: The Safety analysis included all enrolled patients who were transplanted with HSC835 (any patient with a date for HSC835 transplant).||Participants|||Number
656808|NCT01930058|Secondary|Apparent Terminal Plasma Half-life (t½) of MK-8876|t½ is the time required for the maximum plasma drug concentration to reduce by 50% post-dose. Plasma t½ was determined on Day 7 of MK-8876 dosing.|Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post-dose on Day 7|All participants in Panels A, B, and E are included in the analysis.||Hours||Geometric Coefficient of Variation|Geometric Mean
656809|NCT01930058|Secondary|Time to Maximum Plasma Concentration (Tmax) of MK-8876|Tmax is a measure of time required to reach the maximum plasma drug concentration post-dose. Plasma Tmax was calculated on Day 1 and Day 7 of MK-8876 dosing.|Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post-dose on Days 1 and 7|All participants in Panels A, B, and E are included in the analysis.||Hours||Full Range|Median
656810|NCT01930058|Secondary|Trough Plasma Concentration (C24hr) of MK-8876|C24hr is a measure of the plasma drug concentration 24 hours post-dose (i.e., trough concentration). Plasma C24hr was determined on Day 1 and Day 7 of MK-8876 dosing.|24 hours post-dose on Days 1 and 7|All participants in Panels A, B, and E are included in the analysis.||nM||Geometric Coefficient of Variation|Geometric Mean
656811|NCT01930058|Secondary|Maximum Plasma Concentration (Cmax) of MK-8876|Cmax is a measure of the maximum plasma concentration of drug post-dose. Plasma Cmax was determined on Day 1 and Day 7 of MK-8876 dosing.|Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post-dose on Days 1 and 7|All participants in Panels A, B, and E are included in the analysis.||nM||Geometric Coefficient of Variation|Geometric Mean
656812|NCT01930058|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (hr) Post-dose (AUC0-24 hr) of MK-8876|AUC0-24hr is a measure of the mean concentration of drug in plasma after dosing to 24 hr post-dose. Plasma AUC0-24hr was calculated on Day 1 and Day 7 of MK-8876 dosing.|Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post-dose on Days 1 and 7|All participants in Panels A, B, and E are included in the analysis.||µM*hr||Geometric Coefficient of Variation|Geometric Mean
656813|NCT01930058|Primary|Mean Change From Baseline in HCV Viral Load|The mean change (log10) in HCV ribonucleic acid (RNA) from baseline to Day 7 was determined for each panel of participants.|Baseline and Day 7|All participants in Panels A, B, and E are included in the analysis.||Log10 change||Standard Error|Mean
656814|NCT01930045|Primary|Maximum Plasma Concentration (C Max) of Raltegravir in Part 2|Blood was drawn at time 0, and at various intervals up to 12 hours after dosing with raltegravir, in order to determine the geometric mean maximum plasma concentration.|Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose on Day 1 of each period|The per-protocol population consisting of participants from the Raltegravir alone treatment group from Part 1, and the treatment groups from Part 2, who complied with the study procedure and had available data from at least one treatment.||nM||95% Confidence Interval|Geometric Mean
656815|NCT01930045|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC 0-12 Hrs) of Raltegravir in Part 2|Blood was drawn at time 0, and at various intervals up to 12 hours after dosing with raltegravir, in order to determine the geometric mean area under the curve plasma concentration versus time.|Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose on Day 1 of each period|The per-protocol population consisting of participants from the Raltegravir alone treatment group from Part 1, and the treatment groups from Part 2, who complied with the study procedure and had available data from at least one treatment.||hr.nM||95% Confidence Interval|Geometric Mean
656816|NCT01930045|Primary|Plasma Concentration of Raltegravir at 12 Hours (C 12 Hrs) in Part 2|Blood was drawn 12 hours after dosing with raltegravir in order to determine the geometric mean plasma concentration.|12 hours after dosing on Day 1 of each period|The per-protocol population consisting of participants from the Raltegravir alone treatment group from Part 1, and the treatment groups from Part 2, who complied with the study procedure and had available data from at least one treatment.||nM||95% Confidence Interval|Geometric Mean
656817|NCT01930045|Primary|Maximum Plasma Concentration (C Max) of Raltegravir in Part 1|Blood was drawn at time 0, and at various intervals up to 12 hours after dosing with raltegravir, in order to determine the geometric mean maximum plasma concentration.|Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose on Day 1 of each period|The per-protocol population consisting of participants from Part 1 only, who complied with the study procedure and had available data from at least one treatment. One participant did not complete one period of Maalox-4 hour-Raltegravir treatment, resulting in an n = 17.||nM||95% Confidence Interval|Geometric Mean
656818|NCT01930045|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC 0-12 Hrs) of Raltegravir in Part 1|Blood was drawn at time 0, and at various intervals up to 12 hours after dosing with raltegravir in order to determine the geometric mean area under the curve plasma concentration versus time.|Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose on Day 1 of each period|The per-protocol population consisting of participants from Part 1 only, who complied with the study procedure and had available data from at least one treatment. One participant did not complete one period of Maalox-4 hour-Raltegravir treatment, resulting in an n = 17.||hr.nM||95% Confidence Interval|Geometric Mean
656819|NCT01930045|Primary|Plasma Concentration of Raltegravir at 12 Hours (C 12 Hrs) in Part 1|Blood was drawn 12 hours after dosing with raltegravir in order to determine the geometric mean plasma concentration.|12 hours after dosing on Day 1 of each period|The per-protocol population consisting of participants from Part 1 only, who complied with the study procedure and had available data from at least one treatment. One participant did not complete one period of Maalox-4 hour-Raltegravir treatment, resulting in an n = 17.||nM||95% Confidence Interval|Geometric Mean
656820|NCT01929993|Primary|The Prevalence of Incomplete Excision of Dysplasia at the Endocervical Excision Margin as Recognized Histologically.|Incomplete excision was considered when high-grade intraepithelial (CIN2-3) or microinvasive neoplasia was present in the endocervical limit of the excised specimen.|one month after the procedure|Any compromised margin.||participants|||Number
656821|NCT01929980|Primary|Number of Participants With Response|"For Autoimmune Hemolytic Anemia- At least 3 of 5 criteria should be met.
Stabilization of hemoglobin without transfusions by 2 weeks
Conversion of DAT from + to - by 6 weeks
Normalization of serum haptoglobin levels by 6 weeks
Normalization of indirect bilirubin levels by 6 weeks
Reduction in the frequency of transfusions by 50% by 4 weeks
For Autoimmune Neutropenia- At least 2 of 3 criteria should be met.
Stabilization of absolute neutrophil count by 2 weeks
Undetectable antineutrophil antibodies by 6 weeks
Reduction in GCSF dose by 50% by 6 weeks
For Autoimmune Thrombocytopenia- At least 2 of 3 criteria should be met.
Stabilization of platelet count without platelet transfusions by 2 weeks
Undetectable antiplatelet antibodies by 6 weeks
Reduction in the frequency of platelet transfusions by 50% from pre-bortezomib values by 6 weeks"|6 weeks|||participants|||Number
656822|NCT01929889|Primary|Change in Social Cognition at 12 Weeks|"Facial Affect Perception Test that assesses the ability to accurately recognize facially expressed emotions as published by Smith et al 2014; Derntl et al., 2009. This scale ranges from 0-100 percent with a total of 30 trials. We examined the percent correct as the total number of correct responses divided by the total number of completed trials. There were no subscales. 100% accurate is the best outcome and 0% accurate is the worst outcome.
Cognitive Empathy Test that assesses the ability to accurately determine the emotional expression of another person as depicted in a static image of a social interaction as published by Smith et al 2014; Derntl et al., 2009. This scale ranges from 0-100 percent with a total of 60 trials. We examined the percent correct as the total number of correct responses divided by the total number of completed trials. There were no subscales. 100% accurate is the best outcome and 0% accurate is the worst outcome."|baseline and twelve weeks|||units on a scale||Standard Deviation|Mean
656823|NCT01929876|Secondary|Area Under the Curve From Time Zero to 24 Hours [AUC (0-24)] of Itraconazole and Hydroxy-Itraconazole|AUC (0-24) = Area under the plasma concentration versus time curve from time zero (predose) to 24 hours postdose (0-24) of itraconazole and its metabolite hydroxy-itraconazole was assessed using a model independent approach.|Period 2: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 12, 24 hours post cobimetinib dose on Day 4|PK population||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
656824|NCT01929876|Secondary|Tmax of Itraconazole and Hydroxy-Itraconazole|Time to reach maximum observed plasma concentration of itraconazole and its metabolite hydroxy-itraconazole was assessed using a model independent approach.|Period 2: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 144, 192, 240 hours post cobimetinib dose on Day 4|PK population||hours||Full Range|Median
656825|NCT01929876|Secondary|Cmax of Itraconazole and Hydroxy-Itraconazole|Maximum observed plasma concentration of itraconazole and its metabolite hydroxy-itraconazole was assessed using a model independent approach.|Period 2: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 144, 192, 240 hours post cobimetinib dose on Day 4|PK population||ng/mL||Geometric Coefficient of Variation|Geometric Mean
656826|NCT01929876|Secondary|Apparent Volume of Distribution (Vz/F) of Cobimetinib With and Without Itraconazole|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction of drug absorbed.|Period 1: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 144, 192 hours postdose on Day 1; Period 2: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 144, 192, 240 hours post cobimetinib dose on Day 4|"PK population. Number of Participants Analyzed indicates participants evaluable for this outcome measure and n signifies participants evaluable for specified category."||liter (L)||Geometric Coefficient of Variation|Geometric Mean
656827|NCT01929876|Secondary|Apparent Clearance (CL/F) of Cobimetinib With and Without Itraconazole|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated using a model independent approach.|Period 1: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 144, 192 hours postdose on Day 1; Period 2: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 144, 192, 240 hours post cobimetinib dose on Day 4|"PK population. Number of Participants Analyzed indicates participants evaluable for this outcome measure and n signifies participants evaluable for specified category."||liter per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
656828|NCT01929876|Secondary|Plasma Half-Life (t1/2) of Cobimetinib With and Without Itraconazole|Plasma half-life is the time measured for the plasma concentration to decrease by one half.|Period 1: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 144, 192 hours postdose on Day 1; Period 2: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 144, 192, 240 hours post cobimetinib dose on Day 4|"PK population. Number of Participants Analyzed indicates participants evaluable for this outcome measure and n signifies participants evaluable for specified category."||hours||Full Range|Median
656829|NCT01929876|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of Cobimetinib With and Without Itraconazole|AUC (0-t) = Area under the plasma concentration versus time curve from time zero (predose) to time of last quantifiable concentration (0-t) of cobimetinib with and without itraconazole was assessed. It was calculated using the linear trapezoidal rule for increasing concentrations and the logarithmic rule for decreasing concentrations using a model independent approach.|Period 1: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 144, 192 hours postdose on Day 1; Period 2: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 144, 192, 240 hours post cobimetinib dose on Day 4|PK population||nanogram*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
656830|NCT01929876|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Cobimetinib With and Without Itraconazole|Time to reach maximum observed plasma concentration of cobimetinib with and without itraconazole was assessed using a model independent approach.|Period 1: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 144, 192 hours postdose on Day 1; Period 2: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 144, 192, 240 hours post cobimetinib dose on Day 4|PK population||hours||Full Range|Median
657618|NCT01918371|Secondary|Percentage of Participants Switching to a Second or Third Anti-VEGF Agent After First Injection in the Study Eye||UP to 4 Years|All participants with data available.||percentage of participants|||Number
656831|NCT01929876|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - Inf)] of Cobimetinib With and Without Itraconazole|AUC (0 - inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf) of cobimetinib with and without itraconazole, assessed using a model independent approach.|Period 1: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 144, 192 hours postdose on Day 1; Period 2: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 144, 192, 240 hours post cobimetinib dose on Day 4|"PK population. Number of Participants Analyzed indicates participants evaluable for this outcome measure and n signifies participants evaluable for specified category."||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
656832|NCT01929876|Primary|Maximum Observed Plasma Concentration (Cmax) of Cobimetinib With and Without Itraconazole|Maximum observed plasma concentration of cobimetinib with and without itraconazole was assessed using a model independent approach.|Period 1: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 144, 192 hours postdose on Day 1; Period 2: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 144, 192, 240 hours post cobimetinib dose on Day 4|Pharmacokinetic (PK) population consisted of all participants who received at least 1 dose of cobimetinib and had evaluable PK data.||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
656833|NCT01929863|Secondary|Median Time to Observed Peak Plasma Concentration (Tmax) When Co-dosed With GSK2330672 or Placebo on Day 7|Tmax is defined as the time at which Cmax is observed, determined directly from the raw concentration-time data. Blood samples were collected at 0 h (pre-dose within 15 min of dose and began eating breakfast immediately after taking study drug and finished eating in 15 min), 0.25 h, 0.50 h, 1 h, 2 h, 3 h, 4 h (pre-lunch), 5 h, 5.5 h, 6 h, 8 h and 10 h (pre-dinner) on Day 7.|Pre-dose (0 h), 0.25 h, 0.50 h, 1 h, 2 h, 3 h, 4 h (pre-lunch), 5 h, 5.5 h, 6 h, 8 h and 10 h (pre-dinner) on Day 7 of each treatment period|PK Population. Only those participants available at the specified time points were analyzed.||h||Full Range|Median
656834|NCT01929863|Secondary|Maximum Plasma Concentration of Metformin (Cmax) in Presence of GSK2330672 or Placebo on Day 7|Cmax is defined as the first occurrence of the maximum observed plasma concentration determined directly from the raw concentration-time data Blood samples were collected at 0 h (pre-dose within 15 min of dose and began eating breakfast immediately after taking study drug and finished eating in 15 min), 0.25 h, 0.50 h, 1 h, 2 h, 3 h, 4 h (pre-lunch), 5 h, 5.5 h, 6 h, 8 h and 10 h (pre-dinner) on Day 7. Analysis was done using a mixed effects model with fixed effect terms for treatment, period, and sequence. Participant within sequence was fitted as a random effect in the model.|Pre-dose (0 h), 0.25 h, 0.50 h, 1 h, 2 h, 3 h, 4 h (pre-lunch), 5 h, 5.5 h, 6 h, 8 h and 10 h (pre-dinner) on Day 7 of each treatment period|PK Population. Only those participants available at the specified time points were analyzed.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
656835|NCT01929863|Secondary|AUC From Time 0 to 10 h (AUC 0-10 h) of Metformin in Presence of GSK2330672 or Placebo on Day 7|AUC(0-10) for metformin when co-dosed with GSK2330672 or placebo is defined as the the area under the plasma concentration-time curve from time 0 to 10 h. It was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. Blood samples were collected at 0 h (pre-dose within 15 min of dose and began eating breakfast immediately after taking study drug and finished eating in 15 min), 0.25 h, 0.50 h, 1 h, 2 h, 3 h, 4 h (pre-lunch), 5 h, 5.5 h, 6 h, 8 h and 10 h (pre-dinner) on Day 7. Analysis was done using a mixed effects model with fixed effect terms for treatment, period, and sequence. Participant within sequence was fitted as a random effect in the model.|Pre-dose (0 h), 0.25 h, 0.50 h, 1 h, 2 h, 3 h, 4 h (pre-lunch), 5 h, 5.5 h, 6 h, 8 h and 10 h (pre-dinner) on Day 7 of each treatment period|Pharmacokinetic (PK) Population was defined as participants from the safety population who had plasma metformin and or GSK2330672 PK parameter estimates from any portion of the study. Only those participants available at the specified time points were analyzed.||Nanogram (ng)*h/mL||Geometric Coefficient of Variation|Geometric Mean
656836|NCT01929863|Secondary|Maximum and Weighted Mean Change From Baseline in Plasma Glucose Concentrations Over a 24 Hour (h) Period on Day 7|Baseline was defined as the time matched assessment done on Day -1. Change from baseline was calculated by subtracting the baseline (Day -1) time matched values from the post-baseline value (Day 8). Data is reported for fasting glucose level and for weighted mean and maximum values for fasting, 0-4 h, 4-10 h, 10-14 h and 0-24 h. Area under the curve (AUC) with respect to these time interval was calculated using the linear trapezoidal rule by the sum of the areas between each chronological pair of assessments (using observed times). The weighted mean was then determined by dividing the AUC by the observed length of the collection interval (time of last assessment – time of first assessment in h). Analysis was done using analysis of covariance (ANCOVA) model where, change from baseline was summation of baseline, period, sequence and treatment. Participants were fitted as a random effect.|Baseline (Day -1) and Day 7 of each treatment period|Safety Population. Only those participants available at the specified time points were analyzed.||mg/deciliter||Standard Deviation|Mean
656837|NCT01929863|Primary|Mean Change From Baseline in Overall Gastrointestinal Symptom Rating Scale (GSRS) Scores|The impact of gastrointestinal (GI) symptoms on health-related quality of life was assessed using the GSRS. The GSRS is a 15-item related to abdominal pain, reflux, indigestion, diarrhea and constipation syndromes, self-administered questionnaire that assesses the impact of gastrointestinal symptoms during the past week on a scale from 1 (no discomfort at all) to 7 (very severe discomfort). Overall GSRS is the mean of questions 1-15 and range from 1 to 7, with lower scores indicating a better quality of life with respect to gastrointestinal symptoms. Baseline was defined as the assessment done on Day -1. Change from baseline was calculated by subtracting the baseline (Day -1) values from the post-baseline value (Day 8).|Baseline (Day -1) and Day 8 of each treatment period|Safety Population.||Score on scale||Standard Deviation|Mean
656838|NCT01929863|Primary|Number of Participants in Each Category of BSFR Across Day 1 to 7|The BSFR Scale assessed stool quality using a 7-point scale, where 1=separate hard lumps like nuts (difficult to pass) and 7 = watery, no solid pieces (entirely liquid). Bristol Stool Form Scale Rating: 1=separate hard lumps, like nuts, 2=sausage shaped but lumpy, 3=like a sausage or snake but with cracks on its surface, 4=like a sausage or snake, smooth and soft, 5=soft blobs with clear cut edges, 6=fluffy pieces with ragged edges, a mushy stool, 7=watery, no solid pieces. Data is reported for number of events in participants with each category of BSFR scale across Day 1 to 7 post morning dose.|Day 1 to 7 of each treatment period|Safety Population.||Participants|||Count of Participants
658090|NCT01910064|Primary|Local Tolerability (Dryness)|Highest Severity of Local Tolerability Scores Worse Than Baseline|12 months|||participants|||Number
656839|NCT01929863|Primary|Number of Events of Stool or Bowel Movements of Participants Using Bristol Stool Form Rating (BSFR) Scale Across Day 1 to 7|The BSFR Scale assessed stool quality using a 7-point scale, where 1=separate hard lumps like nuts (difficult to pass) and 7=watery, no solid pieces (entirely liquid). Bristol Stool Form Scale Rating: 1=separate hard lumps, like nuts, 2=sausage shaped but lumpy, 3=like a sausage or snake but with cracks on its surface, 4=like a sausage or snake, smooth and soft, 5=soft blobs with clear cut edges, 6=fluffy pieces with ragged edges, a mushy stool, 7=watery, no solid pieces. Data is reported for number of events in participants with each category of BSFR scale across Day 1 to 7 post morning dose.|Day 1 to 7 of each treatment period|Safety Population.||Number of events|||Number
656840|NCT01929863|Primary|Number of Participants With Abnormal (Clinically Significant or Not Clinically Significant) Findings in 12-lead Electrocardiogram (ECG) at Any Time Post Baseline|12-lead ECG assessments were obtained pre-dose at Day 1, Day 3, Day 8 (before discharge) and Follow-up. The assessments were done using an ECG machine that automatically calculated the heart rate and measures PQ, QRS, QT, and QTc(B) intervals. Abnormal ECG findings (clinically significant or not clinically significant) were categorized. The abnormal PCI range for T2DM participants include QTc interval of >450 to <=480 milliseconds (msec) and increase from Baseline QTc interval of > 30 to <=60 msec, PR interval <110 and >220 msec and QRS interval <75 and >110 msec. ECG abnormalities were categorized as clinically significant or not clinically significant based on PCI criteria and judgment of the investigator. Baseline was defined as the mean of three replicate assessments at pre-dose on Day 1.|Up to Follow-up (up to 53 days)|Safety Population. Only those participants available at the specified time points were analyzed.||Participants|||Count of Participants
656841|NCT01929863|Primary|Number of Participants With Vital Sign Values of PCI at Any Time Post Baseline|Vital signs assessment included heart rate (HR), systolic blood pressure (SBP) and diastolic blood pressure (DBP). Assessments were completed at pre morning dose on Day 1 (Baseline), Day 3, Day 8 (before discharge) and Follow-up. Criteria for vital sign values meeting PCI for Type 2 diabetes mellitus (T2DM) included: SBP <85 and >160 millimeters of mercury (mmHg), DBP <45 and >100 mmHg and HR <40 and >110 beats per minute (bpm). Only those parameters for which at least one value of PCI was reported are summarized.|Up to Follow-up (up to 53 days)|Safety Population.||Participants|||Count of Participants
656842|NCT01929863|Primary|Number of Participants With Abnormal Results for Fecal Occult Blood Test|The assessment of fecal occult blood was done on Day 8. Stool sample was obtained any time after dosing on Day 7.|Day 8 of both treatment periods|Safety Population.||Participants|||Count of Participants
656843|NCT01929863|Primary|Mean Specific Gravity of Urine at Any Visit Post Baseline|Urine specific gravity is a laboratory test that shows the concentration of all chemical particles in the urine. The assessments were done at Day -1, Day 3, Day 8 and Follow-up under fasting condition. Baseline was the assessment done on Day -1 (pre dose).|Up to Follow-up (up to 53 days)|Safety Population. Only those participants available at the specified time points were analyzed.||Ratio||Standard Deviation|Mean
656844|NCT01929863|Primary|Number of Participants With Abnormal Values of Urine Dipstic Analysis of Occult Blood, Glucose, Ketones and Proteins at Any Visit Post Baseline|The assessments were done at Day -1, Day 3, Day 8 and Follow-up under fasting condition for urine dipstic analysis of occult blood, glucose, ketones and proteins. Baseline was the assessment done on Day -1 (pre dose). The participants were categorized with results of 1+, 2+, 3+ and trace. Only those parameters for which at least one value of these categories reported are summarized.|Up to Follow-up (up to 53 days)|Safety population.||Participants|||Count of Participants
656845|NCT01929863|Primary|Number of Participants With Abnormal Values of Urine Microscopic Analysis of Bacteria, Hyaline Casts (Semi-quantitive), RBC, Squamous Epithelial Cells and WBC at Any Time Post Baseline|The assessments were done at Day -1, Day 3, Day 8 and Follow-up under fasting condition for microscopic analysis of bacteria, hyaline casts (semi-quantitive), RBC, squamous epithelial cells and WBC. Baseline was the assessment done on Day -1 (pre dose). The participants were categorized as 0-5, 6-10, 10-20, moderate, few and many. Only those parameters for which at least one value of these categories reported are summarized.|Up to Follow-up (up to 53 days)|Safety Population.||Participants|||Count of Participants
656846|NCT01929863|Primary|Number of Participants With the Indicated Haematology Values of PCI at Any Time Post Baseline|The assessments were done at Day -1, Day 3, Day 8 and Follow-up under fasting condition. The following laboratory parameters of clinical haematology were analyzed: platelet count, red blood cells (RBC) count, absolute white blood cells (WBC) count, reticulocyte count, hemoglobin, hematocrit, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), neutrophils, lymphocytes, monocytes, eosinophils and basophils. Baseline was the assessment done on Day -1 (pre dose). Only those parameters for which at least one value of PCI was reported are summarized. Data is reported for participants with high WBC counts PCI, where the PCI value for T2DM participants was (relative low : 0.5 multiplier of lower limit of normal [LLN]; relative high : 1.82 multiplier of upper limit of normal [LLN]; where normal range was 3.8 - 10.8 giga cells per liter (GI/L).|Up to Follow-up (up to 53 days)|Safety Population.||Participants|||Count of Participants
656847|NCT01929863|Primary|Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Importance (PCI) at Any Time Post Baseline|The assessments were done at Day -1, Day 3, Day 8 and Follow-up under fasting condition. The following laboratory parameters of clinical chemistry were analyzed: blood urea nitrogen (BUN), creatinine, fasting triglycerides (TGs), total cholesterol, low-density lipoprotein cholesterol (LDLc), high-density lipoprotein cholesterol (HDLc), sodium, potassium, chloride, total bicarbonate, calcium, aspartate aminotransferase (AST), ALT, gamma glutamyltransferase (GGT), alkaline phosphatase, total and direct bilirubin, uric acid, albumin and total protein. Baseline was the assessment done on Day -1 (pre dose). Only those parameters for which at least one value of PCI was reported are summarized. Data is reported for participants with high glucose PCI, where the PCI value for T2DM participants was ( low < 3.8857 millimole per liter (mmol/L); high > 15 mmol/L; normal range was 3.61 - 5.5 mmol/L).|Up to Follow-up (up to 53 days)|Safety Population.||Participants|||Count of Participants
656924|NCT01929044|Secondary|PID From Pre-dose Baseline at 120 Minutes After First Injection.|Pain intensity difference (PID) from pre-dose baseline at 120 minutes after first injection. It was assessed using an 11-point numerical rating scale (NRS) ranging from 0 = ‘no pain’ to 10 = ‘worst pain possible’.|Baseline and 120 minutes after the first injection|Per-Protocol Set (PPS): All patients in full analysis set (FAS), who revealed no important protocol violations that would impact the analysis of primary endpoint.||Units on a scale||Standard Error|Least Squares Mean
656848|NCT01929863|Primary|Number of Participants With at Least One Adverse Event (AE), Serious Adverse Event (SAE) or Death|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, associated with liver injury and impaired liver function defined as alanine aminotransferase (ALT) >=3 x upper limit of normal (ULN), and total bilirubin >=2 x ULN or international normalized ratio >1.5.|Up to Follow-up (up to 53 days)|Safety Population was defined as all participants enrolled into the study who have received at least one dose of study drug (including metformin, GSK2330672, and matching placebo. One participant withdrew consent after taking period 1 study treatment of placebo + GSK2330672.||Participants|||Count of Participants
656849|NCT01929759|Secondary|Effect of EFV and Its Metabolites|Level of EFV (efavirenz) in Atripla and its two known metabolites known to cause cerebral side effects, 7-hydroxy (OH) EFV and 8-OH EFV, were measured in the plasma prior to switch off Atripla and after 8 weeks of RAL-based regimen (no EFV).|week 0 and week 8|||participants|||Number
656850|NCT01929759|Secondary|Markers of Immune Activation|Change in markers of immune activation and inflammation associated with change to Stibild: sCD14, IP-10,sCD163, IL-6)|week 0 and week 8|Inflammatory markers were measured pre- and post-drug switch from Atripla to Stibild.||pg/ML||Standard Deviation|Mean
656851|NCT01929759|Secondary|ART Regimen Preference|Evaluate patient preference in ART regimen (Atripla, EFV/FTC/TDF versus EVG/COBI/FTC/TDF) through a self-administered questionnaire.|week 0 and week 8|Patients were surveyed at the end of the study with a single question regarding their ART preference. They are asked to pick one of the 3 answers: 1. prefer Atripla, 2. prefer the new drug (Stribild) or 3. no preference. The number of patients who would like to switch to study drug, Stribild, are indicated by the percentage.||Participants|||Count of Participants
656852|NCT01929759|Secondary|Sleep Quality|Assess for changes in sleep pattern and quality prior to and after switching off EFV-based regimen through a self-administered Pittsburg Sleep Quality Index (PSQI). Measure consists of 19 items with each weighted on 0-3 scale and the sum produces a total score, which ranges from 0-21. The lower the score the healthier the sleep quality; minimum Score = 0 (better); maximum Score = 21 (worse).|week 0 and week 8|||units on a scale||Standard Deviation|Mean
656853|NCT01929759|Secondary|Fasting Lipid Profile|Measure the change in fasting lipid panel prior to and after switching off EFV-based regimen.|8 weeks|Change in fasting lipid profile was measured: total cholesterol, HDL and LDL levels.||mg/dl||Standard Deviation|Mean
656854|NCT01929759|Secondary|Neurocognitive Changes|"Assess for changes in cognitive and affective function prior to and after switching off EFV-based regimen. Indexes used to access neurocognitive changes included:
Wechsler Adult Intelligence Scale (WAIS-R) Digital Symbol Substitution Test: sensitive to brain damage, dementia, age and depressive changes. Range of 0-100, the higher the score the better the person's performance
Hamilton Rating Scale for Depression (HAMD): Measure of depression. Score of 0-7 is normal, score of >20 is moderate/severe depression
Depression Anxiety Stress Scale (DASS-21) the lower the score, the less severe depression, anxiety and stress. Scale range of 0-63
Frontal Systems Behavior Scale (FRSBE): Increased score indicates greater behavioral impairment associated with frontal systems, range 37.2 to 186
6. Spielberger state trait anxiety inventory (STAI): the higher the score the greater then anxiety level, range of 20 to 80."|week 0 and week 8|"Several Indexes were used to access neurocognitive changes: WAIS, HAMD, FRSBE, DASS-21, STAI.
Participants were given these tests prior to and after drug switch."||units on a scale||Standard Deviation|Mean
656855|NCT01929759|Secondary|Change in Other Neurometabolite Measured by MRS Between Week 0 and Week 8|Use MRS to evaluate a fuller panel of known neurometabolites (in addition to the primary endpoints) between week 0 and week 8 to identify prominent and significant changes associated with EFV use.|week 0 to week 8|The arbitrary units are expressed as the output from MRS software. While similar to concentration (mM) due to assumptions in the software, it is best expressed as arbitrary units for comparison from week 0 to week 8.||arbitrary units||Standard Deviation|Mean
656856|NCT01929759|Primary|Neural Activation Networks Using Functional Magnetic Resonance Imaging (fMRI)|Assess changes in neural activation correlated with affective disturbances associated with efavirenz-based therapy using fMRI employing an Emotional Word/Go-NoGo task paradigm that probes affective symptomatologies typical with EFV use, specifically anxiety/dysphoria and affective dysregulation and their association with changes in cognitive function. Four brain regions of interests (ROIs) are specified to show the differential frontal-limbic activation patterns in the task-evoked neural responses to the 3 linear contrasts of Pre-switch / Post-switch / Pre- vs. Post-switch: [Negative Word vs. Neutral Word] x [No-Go Trial Block vs. Go Trial Block]: anterior Frontal Pole (aFP), posterior Cingulate Gyrus (pCG), dorsal anterior Cingulate Gyrus (daCG), Left Hippocampus (LHC). A linear mixed-effects model is utilized to examine the effect sizes of the key Regimen/Condition contrasts, with the Subject factor as the random-effect and Age incorporated as a co-variate of no interest.|week 0 and week 8|8 of 10 enrolled patients passed QA testing to be included in the final analyses. The 3 linear contrasts of Pre-switch/Post-switch/Pre- vs. Post-switch: [Neg vs.Neu] x [No-Go vs. Go] are reported as z-score (standardized effect size measures with SD=1). Z-score is obtained for each subject, group Z-score is obtained via a mixed-effects model.||z-score|||Number
656857|NCT01929759|Primary|Change in Neurometabolites Based on Magnetic Resonance Spectroscopy (MRS)|Assess the change in levels of neuro-metabolites measured by MRS from week 0 (before switching to the efavirenz-based therapy) and then at week 8 (after completing 9 weeks of integrase-inhibitor based regimen with Stribild). Two areas of the brain: 1) posterior cingulate gyrus and 2) anterior cingulate will be assessed for the levels of brain Cr, GABA and GLU.|week 0 to week 8|The arbitrary units are expressed as the output from MRS software. While similar to concentration (mM) due to assumptions in the software, it is best expressed as arbitrary units for comparison from week 0 to week 8.||arbitrary units||Standard Deviation|Mean
656980|NCT01928927|Secondary|Change in Waist Circumference From Baseline to Week 24|Absolute change was calculated as the value at week 24 minus the value at baseline.|baseline and week 24|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.
Additionally, have non-missing waist circumference."||cm||Inter-Quartile Range|Median
656858|NCT01929681|Secondary|Rate of Change Over 3 Treatments: Positive and Negative Affect Schedule (PANAS) Positive Items Subscale|"PANAS consists of 10 positive and 10 negative valence word items. Items are rated by the participant to indicate their assessment of how they are feeling about this item right now on a scale of 1(slightly) or not at all through 5 (extremely). 10 of of the items form a positive affect subscale, in which a higher score indicates increased positive affect, with a subscale range of 10 to 50. 10 of the items form a negative affect subscale, in which a higher score indicates more negative affect, with a subscale range of 10 to 50. This outcome measure uses the 10 item positive affect subscale. This outcome measure is the least squares fit of a linear coefficient to the three pretreatment scores for the three treatment days"|Over 3 days of treatment|Subjects completing 3 treatments and 1 visit||units on a scale||Standard Error|Mean
656859|NCT01929681|Secondary|Rate of Change Over 3 Treatments: Montgomery-Asberg Depression Rating Scale (MADRS)|The Montgomery-Asberg Depression Rating scale assesses 10 symptom areas of depression during an interview. Each of the 10 items received a score ranging from 0 to 6. The scale has a range of 0-60 for the reported total. A higher score indicates increased depression for all items and for the total. This outcome measure is the least squares fit of a linear coefficient to the three pretreatment scores for the three treatment days|Over 3 days of treatment|Subjects completing 3 treatments and 1 visit||units on a scale||Standard Error|Mean
656860|NCT01929681|Secondary|Rate of of Change in Daily Improvement Over 3 Treatments: Positive and Negative Affect Schedule (PANAS) Positive Items Subscale|"PANAS consists of 10 positive and 10 negative valence word items. Items are rated by the participant to indicate their assessment of how they are feeling about this item right now on a scale of 1(slightly) or not at all through 5 (extremely). 10 of of the items form a positive affect subscale, in which a higher score indicates increased positive affect, with a subscale range of 10 to 50. 10 of the items form a negative affect subscale, in which a higher score indicates more negative affect, with a subscale range of 10 to 50. This outcome measure uses the 10 item positive affect subscale. This outcome measure is the least squares fit of a linear coefficient to the three post (<30min oost treatment) minus pre (<30min pre treatment) score differences for the three treatment days"|Over 3 days of treatment|Subjects completing 3 treatments and 1 visit||units on a scale||Standard Error|Mean
656861|NCT01929681|Primary|Change Over First Treatment: Positive and Negative Affect Schedule (PANAS) Positive Items Subscale|"PANAS consists of 10 positive and 10 negative valence word items. Items are rated by the participant to indicate their assessment of how they are feeling about this item right now on a scale of 1(slightly) or not at all through 5 (extremely). 10 of of the items form a positive affect subscale, in which a higher score indicates increased positive affect, with a subscale range of 10 to 50. 10 of the items form a negative affect subscale, in which a higher score indicates more negative affect, with a subscale range of 10 to 50. This outcome measure is change in the 10 item positive affect subscale. This outcome measure is the difference between the scale administered immediately (<30min) prior to the first treatment and immediately after (<30min) the first treatment."|90 minutes; change immediately (<30min) prior to the first treatment and immediately after (<30min) the first treatment.|subjects completing 3 treatment visits and 1 followup visit||units on a scale||Standard Deviation|Mean
656862|NCT01929681|Primary|Long Term Change: Montgomery-Åsberg Depression Rating Scale (MADRS)|The Montgomery-Asberg Depression Rating scale assesses 10 symptom areas of depression during an interview. Each of the 10 items received a score ranging from 0 to 6. The scale has a range of 0-60 for the reported total. A higher score indicates increased depression for all items and for the total. This outcome measure is the change from pretreatment baseline acquired at the screening visit to a follow-up visit 7 days after the first treatment.|Variable based on screening visit schedule, > 2 weeks.|Subjects completing 3 treatments and 1 visit||units on a scale||Standard Deviation|Mean
656863|NCT01929473|Secondary|Infection Risk Factors Including Family Numbers, Living Space, With or Without a Cough Patient in the Surroundings, Medical History and Hospitalization|Questionnaire|365 day||||||
656864|NCT01929473|Secondary|Antibodies of Varicella, Mumps and Rubella|Questionnaire|0 day||||||
656865|NCT01929473|Secondary|Incidence of Pertussis|Questionnaire|0 day||||||
656866|NCT01929473|Primary|IgG|Seroincidence of pertussis estimated by the elevation of Ig-G-PT in paired sera(0day, 365day).|0 day, 365 day (2 points)|||EU/mL(log transformed)||Standard Deviation|Mean
656867|NCT01929460|Secondary|Median Cyst Fluid Amylase|Median cyst fluid amylase for classification of mucinous cystic lesions|six weeks|||Units/L||Inter-Quartile Range|Median
656868|NCT01929460|Secondary|Median Cyst Fluid Carcinoembryonic Antigen (CEA)|Median cyst fluid carcinoembryonic antigen (CEA) for classification of mucinous cystic lesions|six weeks|||ng/mL||Inter-Quartile Range|Median
656869|NCT01929460|Secondary|Mean Cyst Fluid Amylase|Mean cyst fluid amylase for classification of mucinous cystic lesions|six weeks|||Units/L||Full Range|Mean
656870|NCT01929460|Secondary|Mean Cyst Fluid Carcinoembryonic Antigen (CEA)|Mean cyst fluid carcinoembryonic antigen (CEA) for classification of mucinous cystic lesions|six weeks|||ng/mL||Full Range|Mean
656871|NCT01929460|Secondary|Procedure-related Complications|Number of patients with procedure-related complications|six weeks after procedure|||participants|||Number
656872|NCT01929460|Secondary|Adverse Drug Reactions|Number of participants with adverse drug reactions|six weeks|||participants|||Number
656873|NCT01929460|Primary|Number of Patients With Pancreas Cyst Infection After EUS-guided Pancreatic Cyst Aspiration|third and final time point (number of patients with pancreas cyst infection after EUS-guided pancreatic cyst aspiration)|At 6 weeks after procedure|||participants|||Number
656874|NCT01929460|Primary|Number of Patients With Pancreas Cyst Infection After EUS-guided Pancreatic Cyst Aspiration|second time point (number of patients with pancreas cyst infection after EUS-guided pancreatic cyst aspiration)|At 4 weeks after procedure|||participants|||Number
656875|NCT01929460|Primary|Number of Patients With Pancreas Cyst Infection After EUS-guided Pancreatic Cyst Aspiration|first time point (number of patients with pancreas cyst infection after EUS-guided pancreatic cyst aspiration)|At 2 weeks after procedure|||participants|||Number
656994|NCT01928927|Secondary|Change in Circulating CD4+ T Cell Count From Baseline to Week 24|Absolute change was calculated as the value at week 24 minus the value at baseline.|baseline and week 24|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.
Additionally, have non-missing CD4+ count."||cells/mm^3||Inter-Quartile Range|Median
656876|NCT01929317|Secondary|"Change From Baseline in Percentage of Awake Time Spent On Without Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase"|"On state is defined as the state at which PD symptoms are well controlled by the drug. Par. were asked to record the duration of their “on ” periods and asleep in diary cards every day. Percentage of awake time spent “On” without troublesome dyskinesias is defined as sum of two days on time without troublesome dyskinesias [“On” time minus “On” time with troublesome dyskinesias] (hours) divided by sum of two days awake time (hours) and multiplified by 100. Change from Baseline was calculated by subtracting the Baseline value (percentage of awake time spent “On” without troublesome dyskinesias) from week 17, 21, 25, 37, 49 and 52 value (percentage of awake time spent “On” without troublesome dyskinesias). Baseline is defined as the value at Week 13. If the value evaluated at week 13 was missing the first observed value post week 13 was used as a Baseline.The analyses for Long term phase was performed using the OC data. In the OC data, no imputation was carried for any missing data."|Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52|FAS2 Population who received L-dopa adjunct in Long term phase. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population.||percentage of awake time spent on||Standard Deviation|Mean
656877|NCT01929317|Secondary|"Change From Baseline in Percentage of Awake Time Spent On at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase"|"On state is defined as the state at which PD symptoms are well controlled by the drug. Participants were asked to record the duration of their “on ” periods and asleep in diary cards every day. Percentage of awake time spent on is defined as sum of two days on time (hours) divided by sum of two days awake time (hours) and multiplified by 100. Change from Baseline was calculated by subtracting the Baseline value (percentage of awake time spent on) from week 17, 21, 25, 37, 49 and 52 value (percentage of awake time spent on). Baseline is defined as the value at Week 13. If the value evaluated at week 13 was missing the first observed value post week 13 was used as a Baseline.The analyses for Long term phase was performed using the OC data. In the OC data, no imputation was carried for any missing data."|Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52|FAS2 Population who received L-dopa adjunct in Long term phase. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population.||percentage of awake time spent on||Standard Deviation|Mean
656878|NCT01929317|Secondary|"Change From Baseline in Actual Hours of Awake Time Spent On Without Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase"|"On state is defined as the state at which PD symptoms are well controlled by the drug. Participants were asked to record the duration of their “on ” periods and asleep in diary cards every day. Change from Baseline in awake time spent “On” without troublesome dyskinesias (actual hours) is calculated as [awake time spent “On” minus awake time spent “On” with troublesome dyskinesias] (hours) at visit minus [awake time spent “On” minus awake time spent “On” with troublesome dyskinesias] (hours) at Baseline. Baseline is defined as the value at Week 13. If the value evaluated at week 13 was missing then first observed value post week 13 was used as a Baseline. The analyses for Long term phase was performed using the OC data. In the OC data, no imputation was carried for any missing data"|Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52|FAS2 Population who received L-dopa adjunct in Long term phase. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population.||hours||Standard Deviation|Mean
656879|NCT01929317|Secondary|"Change From Baseline in Actual Hours of Awake Time Spent On at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase"|"On state is defined as the state at which PD symptoms are well controlled by the drug. Participants were asked to record the duration of their “off ” periods and asleep in diary cards every day. Change from Baseline in awake time spent “On”(actual hours) is calculated as awake time spent “On” (hours) at the week 17, 21, 25, 37, 49 and 52 value minus awake time spent “On” (hours) at Baseline. Baseline is defined as the value at Week 13. If the value evaluated at week 13 was missing then first observed value post week 13 was used as a Baseline. The analyses for Long term phase was performed using the OC data. The OC (observed Case) dataset was defined as the dataset consisting of observed data without any missing data imputation."|Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52|FAS2 Population who received L-dopa adjunct in Long term phase. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population.||hours||Standard Deviation|Mean
656880|NCT01929317|Secondary|"Change From Baseline in the Percentage of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase"|"Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Participants were asked to record the duration of their “off ” periods and asleep in diary cards every day. Percentage of awake time spent “off” is defined as sum of two days off time (hours) divided by sum of two days awake time (hours) and multiplied by 100. Change from Baseline was calculated by subtracting the Baseline value (percentage of awake time spent “off”) from week 17, 21, 25, 37, 49 and 52 value (percentage of awake time spent “off”). Baseline is defined as the value at Week 13, If the value evaluated at week 13 was missing then first observed value post week 13 was used as a Baseline. The analyses for Long term phase was performed using the OC data. In the OC data, no imputation was carried for any missing data."|Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52|FAS2 Population who received L-dopa adjunct in Long term phase. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population.||percentage of awake time spent off||Standard Deviation|Mean
657143|NCT01927120|Secondary|Incidence of Non-relapse Death|Incidence of Non-relapse death/Transplant-related mortality. Non-relapse death is defined as death in continuous remission from primary disease requiring transplantation.|365 days post HCT|All participants.||percentage of participants||95% Confidence Interval|Number
656881|NCT01929317|Secondary|"Change From Baseline in the Actual Hours of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase"|"Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Participants were asked to record the duration of their “off ” periods and asleep in diary cards every day. Change from Baseline was calculated by subtracting the Baseline value (actual hours of awake time spent “off”) from the week 17, 21, 25, 37, 49 and 52 value (proportion of awake time spent “off”). Baseline is defined as the value at Week 13. If the value evaluated at week 13 was missing then first observed value post week 13 was used as a Baseline.The analyses for long term phase was performed using the OC data. In the OC data, no imputation was carried for any missing data"|Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52|FAS2 Population who received L-dopa adjunct in Long term phase. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population.||hours||Standard Deviation|Mean
656882|NCT01929317|Secondary|Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in Long Term Phase.|The Japanese UPDRS assesses the status of Parkinson's Disease (PD) participants objectively. Part III assessed motor examination on 27 items. Participants received a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. Number of participants achieving a 30% or greater and 20% or greater reduction from Baseline in UPDRS total part III score at Weeks 17, 21, 25, 37, 49 and 52,are presented using OC data. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value evaluated at Week 13. If the value evaluated at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The OC (observed Case) dataset was defined as the dataset consisting of observed data without any missing data imputation.|Baseline (Week 13), Weeks 17, 21, 25, 37, 49, 52|FAS2 Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population.||Participants|||Number
656883|NCT01929317|Secondary|Number of Participants Remaining in the Study||From the start of the study medication (Week 0) until Week 52|Safety Population 2 (SP2) compraised of all participants who included in SP1 (receive at least one dose of medication in Dose Increase Effect Verification Phase) and shifted to Long-term Phase and received at least one dose of medication in Long-term Phase.||Participants|||Number
656884|NCT01929317|Secondary|Number of Participants With an Improvement (Responder) in the Clinical Global Impression (CGI) Global Improvement Scale at Week 12|The CGI global improvement scale allows the investigator to rate the participant’s total improvement since the beginning of treatment (Baseline). Scores on the scale range from 1 to 7 (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse). Participants with a CGI global improvement score of <=2 (representing much improved or very much improved) were considered to be moderate improvement (responder). The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data.|Week 12|FAS1 Population. Only those participants available at the specified time points were analyzed.||Participants|||Number
656885|NCT01929317|Secondary|"Change From Baseline in Actual Hours of Awake Time Spent OnWithout Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct"|"On state is defined as the state at which PD symptoms are well controlled by the drug. Participants were asked to record the duration of their “off ” periods and asleep in diary cards every day. Change from Baseline in awake time spent “On” without troublesome dyskinesias (actual hours) is calculated as [awake time spent “On” minus awake time spent “On” with troublesome dyskinesias] (hours) at visit minus [awake time spent “On” minus awake time spent “On” with troublesome dyskinesias] (hours) at Baseline. Baseline is defined as the value at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit."|Baseline, Weeks, 2, 4, 6, 8 and 12|FAS1 Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS1 population.||hours||Standard Deviation|Mean
656886|NCT01929317|Secondary|"Change From Baseline in Actual Hours of Awake Time Spent On at the Indicated Visits Only in Participants Who Received L-dopa Adjunct"|"On state is defined as the state at which PD symptoms are well controlled by the drug. Participants were asked to record the duration of their “off ” periods and asleep in diary cards every day. Change from Baseline in awake time spent “On”(actual hours) is calculated as awake time spent “On” (hours) at the indicated visit minus awake time spent “On” (hours) at Baseline. Baseline is defined as the value at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit."|Baseline, Weeks, 2, 4, 6, 8 and 12|FAS1 Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS1 population.||hours||Standard Deviation|Mean
656887|NCT01929317|Secondary|"Change From Baseline in the Percentage of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct"|"Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Participants were asked to record the duration of their “off ” periods and asleep in diary cards every day. Percentage of awake time spent “off” is defined as sum of two days off time (hours) divided by sum of two days awake time (hours) and multiplied by 100. Change from Baseline was calculated by subtracting the Baseline value (percentage of awake time spent “off”) from the post Baseline value (percentage of awake time spent “off”). Baseline is defined as the value at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit."|Baseline, Weeks, 2, 4, 6, 8 and 12|FAS1 Population. Only those participants available at the specified time points were analyzed.||percentage of awake time spent off||Standard Deviation|Mean
658091|NCT01910064|Primary|Local Tolerability (Scaling)|Highest severity of Local tolerability scores worth than base line|12 months|||participants|||Number
656888|NCT01929317|Secondary|"Change From Baseline in the Actual Hours of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct"|"Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Participants were asked to record the duration of their “off ” periods and asleep in diary cards every day. Change from Baseline in awake time spent “Off”(actual hours) is calculated as awake time spent “Off” (hours) at the indicated visit minus awake time spent “Off” (hours) at Baseline. Baseline is defined as the value at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit."|Baseline, Weeks, 2, 4, 6, 8 and 12|FAS1 Population. Only those participants available at the specified time points were analyzed.||hours||Standard Deviation|Mean
656889|NCT01929317|Secondary|Percent Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Long-term Phase|The Japanese UPDRS assesses the status of PD participants objectively. Part 4 evaluates complications on 11 items, response for 4 items were scored numerically from 0-4 and response for other 7 items were Yes/No questions and responses are numerically scored as 0 for “No” and 1 for “Yes”. The total score for the 11 items ranged from 0 to 23. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value evaluated at Week 13. If the value evaluated at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data.|Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52|FAS2 Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population.||Percent change||Standard Deviation|Mean
656890|NCT01929317|Secondary|Percent Change From Baseline in the Japanese UPDRS Part 3 Total Score at the Indicated Visits in the Long Term Phase|The Japanese UPDRS assessed the status of PD participants objectively. Part 3 evaluated motor examination on 27 items, response for each items were scored numerically from 0-4. The total score for the 27 items ranged from 0 to 108. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value evaluated at Week 13. If the value evaluated at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data.|Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52|FAS2 Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population.||Percent change||Standard Deviation|Mean
656891|NCT01929317|Secondary|Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long-term Phase|"The Japanese UPDRS assesses the status of PD participants objectively. Part 2 evaluates activities of daily living on 13 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 52. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value at Week 13. If the value at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data.Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. On state is defined as the state at which PD symptoms are well controlled by the drug. The score of UPDRS part 2 in off status is rated as '0' (Normal/None), if L-dopa adjunct participants do not have diurnal fluctuations."|Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52|FAS2 Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population.||Percent change||Standard Deviation|Mean
656892|NCT01929317|Secondary|Percent Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Long Term Phase|The Japanese UPDRS assessed the status of PD participants objectively. Part I evaluated mentation, behavior, and mood on 4 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 16. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value evaluated at Week 13. If the value evaluated at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data.|Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52|FAS2 Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population.||Percent change||Standard Deviation|Mean
656893|NCT01929317|Secondary|Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Long Term Phase|The Japanese UPDRS assessed the status of PD participants objectively. Part 4 evaluated complications on 11 items, response for 4 items were scored numerically from 0-4 and response for other 7 items were Yes/No questions and responses are numerically scored as 0 for “No” and 1 for “Yes”. The total score for the 11 items ranged from 0 to 23. A higher score indicates more severe PD symptoms.Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value evaluated at Week 13. If the value evaluated at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data.|Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52|FAS2 Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population.||Scores on a scale||Standard Deviation|Mean
657645|NCT01918332|Primary|sitDBP Changes at Week 8 From Baseline|sitDBP changes of the valsartan 160mg and valsartan placebo groups at Week 8 from baseline|8 weeks|FAS||mmHg||95% Confidence Interval|Least Squares Mean
656894|NCT01929317|Secondary|Mean Change From Baseline in UPDRS Part 3 Total Score at the Indicated Visits for Long Term Phase|The Japanese UPDRS assesses the status of PD participants objectively. Part 3 evaluates motor examination on 27 items, response for each items were scored numerically from 0-4. The total score for the 27 items ranged from 0 to 108. A higher score indicates more severe PD symptoms. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value evaluated at Week 13. If the value evaluated at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data.|Baseline (Week 13), Weeks 17, 21, 25, 37, 49, 52|FAS2 Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population.||Scores on a scale||Standard Deviation|Mean
656895|NCT01929317|Secondary|Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long Term Phase|"The Japanese UPDRS assesses the status of PD participants objectively. Part 2 evaluates activities of daily living on 13 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 52. A higher score indicates more severe PD symptoms.Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value at Week 13. If the value at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data.Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. On state is defined as the state at which PD symptoms are well controlled by the drug. The score of UPDRS part 2 in off status is rated as '0' (Normal/None), if L-dopa adjunct participants do not have diurnal fluctuations."|Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52|FAS2 Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population.||Scores on a scale||Standard Deviation|Mean
656896|NCT01929317|Secondary|Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Long-term Phase|The Japanese UPDRS assessed the status of PD participants objectively. Part I evaluated mentation, behavior, and mood on 4 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 16. A higher score indicates more severe PD symptoms.Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value evaluated at Week 13. If the value evaluated at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data. Full Analysis Set 2 (FAS2) Population comprised of all participants in the FAS1 and shifted to Long-term Phase, excluding those participants who received no dose of study medication and participants without UPDRS part III total score data after supply of the investigational product.|Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52|FAS2 Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population.||Scores on a scale||Standard Deviation|Mean
656897|NCT01929317|Secondary|Percent Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase|The Japanese UPDRS assessed the status of PD participants objectively. Part 4 evaluated complications on 11 items, response for 4 items were scored numerically from 0-4 and response for other 7 items were Yes/No questions and responses are numerically scored as 0 for “No” and 1 for “Yes”. The total score for the 11 items ranged from 0 to 23. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value evaluated at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit.|Baseline, Weeks, 2, 4, 6, 8 and 12|FAS1 Population. Only those participants available at the specified time points were analyzed.||Percent change||Standard Deviation|Mean
656898|NCT01929317|Secondary|Percent Change From Baseline in the Japanese UPDRS Part 3 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase|The Japanese UPDRS assessed the status of PD participants objectively. Part 3 evaluated motor examination on 27 items, response for each items were scored numerically from 0-4. The total score for the 27 items ranged from 0 to 108. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value evaluated at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit.|Baseline, Weeks, 2, 4, 6, 8 and 12|FAS1 Population||Percent change||Standard Deviation|Mean
656899|NCT01929317|Secondary|Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase|"The Japanese UPDRS assesses the status of PD participants objectively. Part 2 evaluates activities of daily living on 13 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 52. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit. Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. On state is defined as the state at which PD symptoms are well controlled by the drug. The score of UPDRS part 2 in off status is rated as '0' (Normal/None), if L-dopa adjunct participants do not have diurnal fluctuations."|Baseline, Weeks, 2, 4, 6, 8 and 12|FAS1 Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS1 population.||Percent change||Standard Deviation|Mean
656900|NCT01929317|Secondary|Percent Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase|The Japanese UPDRS assessed the status of PD participants objectively. Part I evaluated mentation, behavior, and mood on 4 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 16. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value evaluated at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit.|Baseline, Weeks, 2, 4, 6, 8 and 12|FAS1 Population. Only those participants available at the specified time points were analyzed.||Percent change||Standard Deviation|Mean
656901|NCT01929317|Secondary|Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase|The Japanese UPDRS assessed the status of PD participants objectively. Part 4 evaluated complications on 11 items, response for 4 items were scored numerically from 0-4 and response for other 7 items were Yes/No questions and responses are numerically scored as 0 for “No” and 1 for “Yes”. The total score for the 11 items ranged from 0 to 23. A higher score indicates more severe PD symptoms. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value evaluated at Week 0. The analyses for the Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit.|Baseline, Weeks, 2, 4, 6, 8 and 12|FAS1 Population||Scores on a scale||Standard Deviation|Mean
656902|NCT01929317|Secondary|Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase|"The Japanese UPDRS assesses the status of PD participants objectively. Part 2 evaluated activities of daily living on 13 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 52. A higher score indicates more severe PD symptoms. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value evaluated at Week 0. The analyses for the Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit. Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. On state is defined as the state at which PD symptoms are well controlled by the drug. The score of UPDRS part 2 in off status is rated as '0' (Normal/None), if L-dopa adjunct participants do not have diurnal fluctuations."|Baseline, Weeks, 2, 4, 6, 8 and 12|FAS1 Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS1 population.||Scores on a scale||Standard Deviation|Mean
656903|NCT01929317|Secondary|Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase|The Japanese UPDRS assesses the status of PD participants objectively. Part I evaluated mentation, behavior, and mood on 4 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 16. A higher score indicates more severe PD symptoms. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value evaluated at Week 0. The analyses for the Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at the planned visit.|Baseline, Weeks, 2, 4, 6, 8 and 12|FAS1 Population||Scores on a scale||Standard Deviation|Mean
656904|NCT01929317|Secondary|Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in the Dose Increase Effect Verification Phase|The Japanese UPDRS assesses the status of Parkinson's Disease (PD) participants objectively. Part III assessed motor examination on 27 items. Participants received a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. Number of participants achieving a 30% or greater and 20% or greater reduction from Baseline in UPDRS total part III score at Weeks 2, 4, 6, 8, and 12 are presented using LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit. The imputation was conducted using the data within only the Dose Increase Effect Verification Phase; therefore, the value observed in the Dose Increase Effect Verification Phase was not used to impute a missing data in the Long-term Phase.|Baseline, Weeks, 2, 4, 6, 8 and 12|FAS1 Population||Participants|||Number
656905|NCT01929317|Secondary|Mean Change From Baseline (Week 0) in UPDRS Part III Total Score at the Indicated Visits|The Japanese Unified Parkinson’s Disease Rating Scale (UPDRS) assesses the status of Parkinson's Disease (PD) participants objectively. Part III assessed motor examination on 27 items. Participants received a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. Baseline is defined as the value evaluated at Week 0. Mean change from Baseline was calculated as the total score at Week 12 minus the total score at Baseline. The analyses for the Dose Increase Effect Verification Phase was performed using the last observation carried forward (LOCF) data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit. The imputation was conducted using the data within only the Dose Increase Effect Verification Phase; therefore, the value observed in the Dose Increase Effect Verification Phase was not used to impute a missing data in the Long-term Phase.|Baseline, Weeks, 2, 4, 6, 8 and 12|Full Analysis Set 1 (FAS1) Population: all participants excluding those participants who received no dose of study medication and participants without UPDRS part III total score data after supply of the investigational product.||Scores on a scale||Standard Deviation|Mean
656923|NCT01929044|Secondary|Global Assessment of Efficacy by the Patient at 120 Minutes After the First Injection|Global assessment of efficacy by the patient. The patient was to assess the efficacy at 120 min after the first injection using a 4-point rating scale by answering the question: “How would you rate the effect of the study medication for relieving your acute gastric or intestinal spasm-like pain?” (0 = poor; 1 = fair; 2 = good; 3 = very good).|120 minutes after the first injection|Per-Protocol Set (PPS): All patients in full analysis set (FAS), who revealed no important protocol violations that would impact the analysis of primary endpoint.||Percentage of Patients|||Number
658092|NCT01910064|Primary|Local Tolerability (Erythema)|Highest severity of Local tolerability scores worth than base line|12 monhths|||participants|||Number
656906|NCT01929317|Primary|Mean Change From Baseline (Week 0) in UPDRS Part III Total Score at Week 12 in the CR High-dose Group|The Japanese Unified Parkinson’s Disease Rating Scale (UPDRS) assesses the status of Parkinson's Disease (PD) participants objectively. Part III assessed motor examination on 27 items. Participants received a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. Baseline is defined as the value evaluated at Week 0. Mean change from Baseline was calculated as the total score at Week 12 minus the total score at Baseline. The analyses for the Dose Increase Effect Verification Phase was performed using the last observation carried forward (LOCF) data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit. The imputation was conducted using the data within only the Dose Increase Effect Verification Phase; therefore, the value observed in the Dose Increase Effect Verification Phase was not used to impute a missing data in the Long-term Phase.|Baseline and Week 12|Full Analysis Set 1 (FAS1) Population: all participants excluding those participants who received no dose of study medication and participants without UPDRS part III total score data after supply of the investigational product.||Scores on a scale||Standard Deviation|Mean
656907|NCT01929135|Secondary|Change in Gingival Index|"Determined as score assigned to each site evaluated respect to clinical criteria as followed:
Score Criteria:
0. No inflammation
Mild inflammation, slight change in color, slight edema, no bleeding on probing.
Moderate inflammation, moderate glazing, redness, bleeding on probing.
Severe inflammation, marked redness and hypertrophy, ulceration, tendency to spontaneous bleeding.
Then was calculated a score for each sextant summed the score and divided by the number of examined sites. Later was summed each sextant score and divided by sextant evaluated.
The change was calculated as baseline measure minus 1 month later measure."|baseline and 1 month after intervention|||score on a scale||Standard Deviation|Mean
656908|NCT01929135|Secondary|Change in Bleeding on Probing Index (BOP)|"The bleeding on probing index (BOP) will be determined by assigning + to the presence of bleeding on vestibular / palatine probing of the tooth examined and with a sign - the abscence. Later the + signs will be summed and divided by the number of sites examined.
Change in BOP: baseline measure minus 1 month later measure."|baseline and 1 month after intervention|||percentage of BOP||Standard Deviation|Mean
656909|NCT01929135|Secondary|Change in Clinical Attachment Level (CAL)|"The Clinical Attachment Level (CAL) is defined as the distance from the cement-enamel junction to the fornix of the pocket. For each tooth will be performed periodontal probing at 6 sites (mesiobuccal, mediobuccal, distobuccal mesiolingual / palatal mediolingual / distolingual palatal / lingual).
Change in CAL: baseline measure minus 1 month later measure."|baseline and 1 month after intervention|||millimeters||Standard Deviation|Mean
656910|NCT01929135|Secondary|Change in Mean Pocket Depth (PD)|"The PD will be defined as the distance from the free gingival margin to the bottom of the pocket. For each tooth will be conducted periodontal probing at 6 sites (mesiobuccal, mediobuccal, distobuccal, mesiolingual / palatal, mediolingual / palatal, distolingual/ palatal).
Change in mean PD: baseline measure minus 1 month later measure."|baseline and 1 month later|||millimeters||Standard Deviation|Mean
656911|NCT01929135|Primary|Change in Periodontal Inflammation Surface Area (PISA)|"PISA will be computed through an Excel spreadsheet, using data of clinical attachment level, gingival recession and bleeding on probing.
Change in PISA: baseline measure minus 1 month later measure."|baseline and 1 month later of intervention|||square millimeters||Standard Deviation|Mean
656912|NCT01929083|Other Pre-specified|Ratio of Serum Progesterone:Estradiol Concentrations During the Progesterone and Placebo Phases||After 7 days of progesterone or placebo|||Ratio||Standard Deviation|Mean
656913|NCT01929083|Other Pre-specified|Serum Progesterone Concentrations During Progesterone and Placebo Phases||After 7 days of progesterone or placebo|||ng/mL||Standard Deviation|Mean
656914|NCT01929083|Other Pre-specified|Serum Estradiol Concentrations During the Progesterone and Placebo Phases||Following 7 days of progesterone or placebo|||pg/mL||Standard Deviation|Mean
656915|NCT01929083|Other Pre-specified|Maximum (Peak) Serum Ibutilide Concentrations During Progesterone and Placebo Phases||Within 1 hour following ibutilide administration (0, 15 & 30 minutes and 1 hours.)|||pg/mL||Standard Deviation|Mean
656916|NCT01929083|Other Pre-specified|Adverse Effects Associated With Ibutilide in the Progesterone and Placebo Phases||Within 8 hours following ibutilide administration|||percentage of participants|||Number
656917|NCT01929083|Primary|Area Under the QTcI - Time Curve (AUEC)||From beginning of 10-minute ibutilide infusion to 1 hour following ibutilide infusion|||ms*hr||Standard Deviation|Mean
656918|NCT01929083|Primary|Maximum % Change From Baseline in QTcI Intervals Following Ibutilide Administration||After 7 days of progesterone or placebo|||percentage change from baseline value||Standard Deviation|Mean
656919|NCT01929083|Secondary|Incidence of Progesterone-associated Adverse Effects Compared to Placebo||During 7 days of treatment with oral progesterone or placebo|||percentage of participants|||Number
656920|NCT01929083|Primary|Maximum Individual-corrected QT Interval (QTcI)|QT intervals will be corrected as follows: Prior to randomization, subjects will come to the Indiana Clinical Research Center for a 12-hour stay, during which three ECGs, one minute apart, will be obtained at the following times: 0, 15 & 30 minutes, and 1, 2, 4, 6, 8, and 12 hours. Subjects will be discharged, and then return then next morning for the 24 hour ECG. QT and RR intervals will be used to determine each subject’s individual rate-corrected QT interval (QTcI) using the parabolic model QT = β•RRα, where RR is the interval between adjacent QRS complexes, and α and β are subject-specific correction factors.|0, 15 & 30 minutes, and 1, 2, 4, 6, 8, and 12 hours post-ibutilide administration|||ms||Standard Deviation|Mean
656921|NCT01929083|Primary|Baseline (Pre-Ibutilide) QTcI Intervals||After 7 days of progesterone or placebo, prior to receiving IV ibutilide|||ms||Standard Deviation|Mean
656922|NCT01929044|Secondary|Proportion of Patients Who Need the Second Injection|Proportion of patients who need the second injection at 20 minutes after the first injection.|20 minutes after the first injection.|Per-Protocol Set (PPS): All patients in full analysis set (FAS), who revealed no important protocol violations that would impact the analysis of primary endpoint.||Percentage of Patients||95% Confidence Interval|Number
656995|NCT01928927|Secondary|Change in Circulating CD4+ T Cell Count From Baseline to Week 12|Absolute change was calculated as the value at week 12 minus the value at baseline.|baseline and week 12|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.
Additionally, have non-missing CD4+ count."||cells/mm^3||Inter-Quartile Range|Median
656925|NCT01929044|Secondary|PID From Pre-dose Baseline at 60 Minutes After First Injection.|Pain intensity difference (PID) from pre-dose baseline at 60 minutes after first injection. It was assessed using an 11-point numerical rating scale (NRS) ranging from 0 = ‘no pain’ to 10 = ‘worst pain possible’.|Baseline and 60 minutes after the first injection|Per-Protocol Set (PPS): All patients in full analysis set (FAS), who revealed no important protocol violations that would impact the analysis of primary endpoint.||Units on a scale||Standard Error|Least Squares Mean
656926|NCT01929044|Secondary|PID From Pre-dose Baseline at 30 Minutes After First Injection.|Pain intensity difference (PID) from pre-dose baseline at 30 minutes after first injection. It was assessed using an 11-point numerical rating scale (NRS) ranging from 0 = ‘no pain’ to 10 = ‘worst pain possible’.|Baseline and 30 minutes after the first injection|Per-Protocol Set (PPS): All patients in full analysis set (FAS), who revealed no important protocol violations that would impact the analysis of primary endpoint.||Units on a scale||Standard Error|Least Squares Mean
656927|NCT01929044|Secondary|PID From Pre-dose Baseline at 10 Minutes After First Injection.|Pain intensity difference (PID) from pre-dose baseline at 10 minutes after first injection. It was assessed using an 11-point numerical rating scale (NRS) ranging from 0 = ‘no pain’ to 10 = ‘worst pain possible’.|Baseline and 10 minutes after the first injection|Per-Protocol Set (PPS): All patients in full analysis set (FAS), who revealed no important protocol violations that would impact the analysis of primary endpoint.||Units on a scale||Standard Error|Least Squares Mean
656928|NCT01929044|Primary|PID From Pre-dose Baseline at 20 Minutes After First Injection.|Pain intensity difference (PID) from pre-dose baseline at 20 minutes after first injection. It was assessed using an 11-point numerical rating scale (NRS) ranging from 0 = ‘no pain’ to 10 = ‘worst pain possible’.|Baseline and 20 minutes after the first injection|Per-Protocol Set (PPS): All patients in full analysis set (FAS: all patients who provided any data for the primary efficacy endpoint constituted the full analysis set.), who revealed no important protocol violations that would impact the analysis of primary endpoint||Units on a scale||Standard Error|Least Squares Mean
656929|NCT01929031|Secondary|Time to Meaningful Pain Relief|Time to meaningful pain relief was captured by a stopwatch, which was started by the study staff immediately after the administration of the first dose of trial medication and which was to be stopped by the patient as soon as he/she felt meaningful pain relief. Time to meaningful pain relief was censored at 8 hours.|8 hours|Patients who used at least one dose of study medication and provided any post-treatment data for the primary efficacy endpoint (FAS)||hours||95% Confidence Interval|Median
656930|NCT01929031|Secondary|Duration of Pain Relief|Duration of pain relief was defined as the time between the administration of first dose of trial medication and first dose of rescue medication or second dose of trial medication, whichever was first. Duration of pain relief was censored at 8 hours.|8 hours|Patients who used at least one dose of study medication and provided any post-treatment data for the primary efficacy endpoint (FAS)||hours||95% Confidence Interval|Median
656931|NCT01929031|Secondary|Time-weighted Sum of Pain Relief (PAR) and Pain Intensity Difference (PID) From 0 to 2 Hours (SPRID0-2h)|SPRID0-2h: Time-weighted sum of PAR and PID from 0 to 2 hours, score range: -10 (worst) to 28 (best). PI was assessed on a 0-10 numerical pain rating scale (NPRS), where 0=no pain and 10=worst possible pain, pre-dose and at 0.25,0.5,0.75,1,1.5 and 2 hours; PAR was assessed on a 5-point verbal rating scale (VRS) (0=none to 4=complete) at the same post-dose time points. Time-weights were equal to the elapsed time (hour) between the time point of interest and the preceding time point. All PAR and pain intensity (PI) assessments completed after the patient had taken rescue medication or the second dose of study medication, whichever was first, until hour 2 was considered missing. Last observation carried forward (LOCF) was used with the last completed PI/PAR assessments prior to first rescue/second study medication, whichever was first, to impute missing values up to 2 hours.|0 to 2 hours|Patients who used at least one dose of study medication and provided any post-treatment data for the primary efficacy endpoint (FAS)||units on a scale||Standard Error|Least Squares Mean
656932|NCT01929031|Primary|Time-weighted Sum of Pain Relief (PAR) and Pain Intensity Difference (PID) From 0 to 8 Hours (SPRID0-8h)|SPRID0-8h: Time-weighted sum of PAR and PID from 0 to 8 hours, score range: -40 (worst) to 112 (best). PI was assessed on a 0-10 numerical pain rating scale (NPRS), where 0=no pain and 10=worst possible pain, pre-dose and at 0.25,0.5,0.75,1,1.5,2,3,4,5, 6,7 and 8 hours; PAR was assessed on a 5-point verbal rating scale (VRS) (0=none to 4=complete) at the same post-dose time points. Time-weights were equal to the elapsed time (hour) between the time point of interest and the preceding time point. All PAR and pain intensity (PI) assessments completed after the patient had taken rescue medication or the second dose of study medication, whichever was first, until hour 8 were considered missing. Last observation carried forward (LOCF) was used with the last completed PI/PAR assessments prior to first rescue/second study medication, whichever was first, to impute missing values up to 8 hours.|0 to 8 hours|Randomized patients who used at least one dose of study medication and provided any post-treatment data for the primary efficacy endpoint (FAS)||units on a scale||Standard Error|Least Squares Mean
656933|NCT01928940|Secondary|Phase II: Number of Participants With Worst-case On-therapy Change From Baseline in Left Ventricular Ejection Fraction as Assessed by Echocardiogram|Absolute change from Baseline in LVEF were summarized at each scheduled assessment time and in the worst-case post Baseline. Only the post Baseline assessments that used the same method (ECHO or MUGA) as the Baseline assessments were used to derive the change from Baseline. The change from Baseline was categorized as: any increase; no change; 0-<10 Decrease, 10-19 Decrease, >=20 Decrease, >=10 Decrease and >= LLN, >=10 Decrease and below LLN, >=20 Decrease and >=LLN and >=20 Decrease and below LLN. The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments.|From Baseline until the post-treatment Visit (average of 1.38 years)|ATS Population||Participants|||Number
656934|NCT01928940|Secondary|Phase II: Number of Participants With the Indicated Electrocardiogram Findings at the Indicated Time Points|Single 12-lead ECGs were performed at Baseline, Weeks 3 to 132 and post-treatment Visit. ECG findings were categorized as: normal, abnormal - CS, or abnormal - NCS, as determined by the investigator.|From Baseline until the post-treatment Visit (average of 1.38 years)|ATS Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).||Participants|||Number
657055|NCT01928771|Secondary|Number of Patients With >=1 Asthma Exacerbations||Immediately following the first administration of study drug through Study Week 48.|Full analysis set, Baseline eosinophils >=300/uL||Participants|||Number
656935|NCT01928940|Secondary|Phase II: Change From Baseline in Weight at the Indicated Time Points|Mean change in body weight from baseline was determined. Change from Baseline was calculated as the individual post-Baseline value (Weeks 3 to 132 and post-treatment Visit) minus the Baseline value. The Baseline value is defined as the last pre-treatment value observed.|From Baseline until the post-treatment Visit (average of 1.38 years)|ATS Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).||Kg||Standard Deviation|Mean
656936|NCT01928940|Secondary|Phase II: Change From Baseline in Oxygen Saturation Measured Via Pulse Oxymetry at the Indicated Time Points|Oxygen saturation measures the capacity of blood to transport oxygen to other parts of the body. Oxygen binds to hemoglobin in red blood cells when moving through the lungs. A pulse oximeter uses two frequencies of light (red and infrared) to determine the percentage of hemoglobin in the blood that is saturated with oxygen, that is called as blood oxygen saturation, or SpO2. Change from Baseline was calculated as the individual post-Baseline value (Days 8 and 15; Weeks 3 to 132 and post-treatment Visit) minus the Baseline value. The Baseline value is defined as the last pre-treatment value observed.|From Baseline until the post-treatment Visit (average of 1.38 years)|ATS Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).||Percentage of oxygen in blood||Standard Deviation|Mean
656937|NCT01928940|Secondary|Phase II: Number of Participants With Worst-case On-therapy Change From Baseline in Temperature|Change from Baseline in temperature is categorized as a decrease to <=35 degrees C, change to normal or no change as 35-38 degrees C, and increase to >=38 degrees C relative to the Baseline value. Participants with a missing Baseline value are assumed to have a normal Baseline value. Participants were counted twice if the participant temperature value decreased to <=35 degrees C and increased to >=38 degrees C post-Baseline. The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments.|From Baseline until the post-treatment Visit (average of 1.38 years)|ATS Population||Participants|||Number
656938|NCT01928940|Secondary|Phase II: Number of Participants With Worst-case On-therapy Change From Baseline in Heart Rate|Change from Baseline in heart rate is categorized as decrease to <60 bpm, change to normal or no change, and increase to >100 bpm relative to the Baseline value. Participants with a missing Baseline value are assumed to have a normal Baseline value. Participants were counted twice if the participant's heart rate value decreased to <60 bpm and increased to >100 bpm post-Baseline. The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments.|From Baseline until the post-treatment Visit (average of 1.38 years)|ATS Population||Participants|||Number
656939|NCT01928940|Secondary|Phase II: Number of Participants With Worst-case On-therapy Increase From Baseline in Systolic and Diastolic Blood Pressure to Grade 2 or Grade 3|SBP and DBP values were graded using (NCI CTCAE version 4.0). SBP was categorized as: G1 (Increase to >=120 to 140 mmHg), G2 (Increase to >=140 to <160 mmHg), and G3 (Increase to >=160 mmHg). DBP was categorized as: G1 (Increase to >=80 to <90 mmHg), G2 (Increase to >=90 to <100 mmHg), and G3 (Increase to >=100 mmHg). The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments. An increase is defined as an increase in the CTCAE grade relative to the Baseline grade. Participants with missing Baseline values were assumed to have a Baseline value of G0.|From Baseline until the post-treatment Visit (average of 1.38 years)|ATS Population||Participants|||Number
656940|NCT01928940|Secondary|Phase II: Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in ECOG Perormance Status|The ECOG pef status 5-point scale is used to assess how a participant's disease is progressing, to assess how the disease affects the daily living abilities of the par. and to determine appropriate treatment and prognosis: G0, fully active, able to carry on all pre-disease pef without restriction. G1, restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, example, light house work, office work. G2, ambulatory and capable of all selfcare, but unable to carry out any work activities; up and about >50% of waking hrs. G3, capable of only limited selfcare; confined to bed or chair >50% of waking hrs. G4, completely disabled; cannot carry on any selfcare; totally confined to bed or chair. G5, dead. The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments. Number of par. who improved, had no change, or deteriorated in pef status from BL is summarized.|From Baseline until the post-treatment Visit (average of 1.38 years)|ATS Population||Participants|||Number
656941|NCT01928940|Secondary|Phase II: Number of Participants With the Indicated Urinalysis Results|Urine samples were collected for urine dipstick analysis at Baseline and at the post-treatment Visit. The number of participants with negative (absence) and positive (presence: trace, 1+, 2+, 3+, 4+ or 5+) results for UOB, UGLU, UKET, UP and UUBIL were summarized. The Baseline value is defined as the last pre-treatment value observed.|From Baseline until the post-treatment Visit (average of 1.38 years)|ATS Population||Participants|||Number
656942|NCT01928940|Secondary|Phase II: Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Hematology Parameters|Hematology parameters were summarized according to NCI CTCAE G, version 4.0 as: G1, Mild; G2, Moderate; G3, Severe; G4, Life-threatening or disabling; G5, Death. Data are presented for only those parameters for which an increase to G3 or G4 from Baseline G occurred. For hematology parameters that were not graded according to NCI CTCAE criteria, were categorized as High and Low with respect to the normal range. Data are presented only for those parameters for which the category decreased to Low or increased to High relative to the Baseline category. The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments. Hematology parameters included: hemoglobin, lymphocytes, total neutrophils, platelet count, WBC counts, basophils, eosinophils, hematocrit, MCHC, MCH, MCV, monocytes and RBC count.|From Baseline until the post-treatment Visit (average of 1.38 years)|ATS Population||Participants|||Number
656950|NCT01928940|Secondary|Phase I: Number of Participants With Unconfirmed Overall Response Rate|"ORR is defined as the percentage of participants with an unconfirmed CR or PR according to RECIST version 1.1. RECIST is a set of rules that define when tumors in cancer participants improve (respond), stay the same (stabilize), or worsen (progress) during treatment. CR is defined as disappearance of all target lesions. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions after treatment from Baseline (before study drug administration). Unconfirmed ORR was assessed by investigator and BICR."|Every 8 weeks from start of the treatment until disease progression, death, or withdrawal of consent (average of 1.38 years)|ATS Population||Participants|||Number
656943|NCT01928940|Secondary|Phase II: Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Clinical Chemistry Parameters|CCPs were graded according to NCI CTCAE garde version 4.0 as: G1, Mild; G2, Moderate; G3, Severe; G4, Life-threatening or disabling; G5, Death. Data are presented for only those parameters for which an increase to G3 or G4 from Baseline grade occurred. CCPs that were not graded according to NCI CTCAE criteria, were categorized as High and Low with respect to the normal range. Data are presented only for those parameters for which the category decreased to Low or increased to High relative to the Baseline category. The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments. CCPs included: albumin, alkaline phosphatase, ALT, AST, total bilirubin, calcium, creatinine, glucose, potassium, magnesium, sodium, inorganic phosphorus, chloride, LDH, total protein, urea/BUN and uric acid.|From Baseline until the post-treatment Visit (average of 1.38 years)|ATS Population||Participants|||Number
656944|NCT01928940|Secondary|Phase II: Number of Participants With Any Adverse Event and Any Serious Adverse Event|An AE is defined as any untoward MO in a part. temporally associated with the use of a MP, whether or not considered related to the MP and can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. SAE is defined as any untoward MO that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, a congenital anomaly/birth defect and protocol-specific SAEs:ALT>=3xULN and bilirubin>=2xULN(>35% direct) (or ALT>=3xULN, international normalized ratio>1.5), any new primary cancers, treatment emergent malignancies except basal cell carcinoma, symptomatic or asymptomatic LVEF decrease, retinal pigment epithelial detachment or retinal vein occlusion, pyrexia with hypotension,or dehydration or renal insufficiency,or severe (>=G3) rigor/chills.|From the start of study treatment until 30 days after study treatment discontinuation (average of 1.38 years)|ATS Population||Participants|||Number
656945|NCT01928940|Secondary|Phase II: Duration of Response|Duration of response is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause among participants with confirmed CR or PR. The participant who showed a CR or PR was included in the analysis of duration of response. Duration of response was assessed by investigator and BICR. Please note the values of the Full Range (min, max) are described irregardless of censoring at data cut-off.|From start of the treatment until disease progression or death (average of 1.38 years)|ATS Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ATS population.||Weeks||Full Range|Median
656946|NCT01928940|Secondary|Phase II: Progression Free Survival (PFS)|PFS is defined as the time from the first dose of study treatment to the earliest date of disease progression or death due to any cause. The length of this interval is estimated as the date of death or disease progression minus the date of first dose plus one day. The date of documented disease progression is defined as the date of disease progression based on radiologic evidence. Participants with documented date of disease progresssion or death and who had not received subsequent anticancer treatment prior to the date of documented disease progression or death were included in the analysis of PFS. PFS was assessed by investigator and BICR. Please note the values of the Full Range (min, max) are described irregardless of censoring at data cut-off.|From start of the treatment until disease progression or death (average of 1.38 years)|ATS Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ATS population.||Weeks||Full Range|Median
656947|NCT01928940|Secondary|Phase II: Number of Participants With Unconfirmed Overall Response|"ORR is defined as the percentage of participants with an unconfirmed CR or PR according to RECIST version 1.1. RECIST is a set of rules that define when tumors in cancer participants improve (respond), stay the same (stabilize), or worsen (progress) during treatment. CR is defined as disappearance of all target lesions. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions after treatment from Baseline (before study drug administration). Unconfirmed ORR was assessed by investigator and BICR."|Every 8 weeks from start of the treatment until disease progression, death, or withdrawal of consent (average of 1.38 years)|ATS Population||Participants|||Number
656948|NCT01928940|Secondary|Phase I: Duration of Response|Duration of response is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause among participants with confirmed CR or PR. The participant who showed a CR or PR was included in the analysis of duration of response. Duration of response was assessed by investigator and BICR. Please note the values of the Full Range (min, max) are described irregardless of censoring at data cut-off.|From start of the treatment until disease progression or death (average of 1.38 years)|ATS Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ATS population.||Weeks||Full Range|Median
656949|NCT01928940|Secondary|Phase I: Progression Free Survival (PFS)|PFS is defined as the time from the first dose of study treatment to the earliest date of disease progression or death due to any cause. The length of this interval is estimated as the date of death or disease progression minus the date of first dose plus one day. The date of documented disease progression is defined as the date of disease progression based on radiologic evidence. Participants with documented date of disease progresssion or death and who had not received subsequent anticancer treatment prior to the date of documented disease progression or death were included in the analysis of PFS. PFS was assessed by investigator and BICR. Please note the values of the Full Range (min, max) are described irregardless of censoring at data cut-off.|From start of the treatment until disease progression or death (average of 1.38 years)|ATS Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ATS population.||Weeks||Full Range|Median
657056|NCT01928771|Secondary|Annual Asthma Exacerbation Rate Resulting Emergency Room Visits and Hospitalizations|The annual exacerbation rate associated with an emergency room visit or a hospitalization (adjudicated)|Immediately following the first administration of study drug through Study Week 48.|Full analysis set, Baseline eosinophils >=300/uL||events/year||95% Confidence Interval|Least Squares Mean
656951|NCT01928940|Secondary|Phase I: Number of Participants With Confirmed Overall Response Rate|"Confirmed ORR is defined as the percentage of participants with a confirmed CR or PR according to RECIST, version 1.1. RECIST is a set of rules that define when tumors in cancer participants improve (respond), stay the same (stabilize), or worsen (progress) during treatment. CR is defined as the disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions after treatment from Baseline (before study drug administration). ORR was assessed by investigator and BICR."|Every 8 weeks from start of the treatment until disease progression, death, or withdrawal of consent (average of 1.38 years)|ATS Population||Participants|||Number
656952|NCT01928940|Secondary|Phase I: Time of Occurrence of Cmax (Tmax) and Terminal Phase Half Life (t1/2) of GSK2118436 and Metabolites, and GSK1120212 After a Single and Repeat Dose|Blood samples were collected from each participant at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hr after administration of GSK2118436 + GSK1120212 on Day 1 (single dose) and at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hr post-dose on Day 21 (repeat dose) for PK analysis. GSK2118436 metabolites included GSK2285403, GSK2298683, and GSK2167542. Tmax is defined as the time of occurrence of Cmax. Tmax was determined directly from the raw concentration-time data. The apparent terminal elimination half-life (t1/2) obtained as the ratio of ln2/lamdaz, where lamdaz is the terminal phase rate constant estimated by linear regression analysis of the log transformed concentration-time data. . T1/2 was calculated only at Day 1.|At pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hr after administration of GSK2118436 + GSK1120212 on Day 1 (single dose) and at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hr on Day 21 (repeat dose)|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles)||hr||Full Range|Median
656953|NCT01928940|Secondary|Phase I: Plasma Trough Concentration (Ctau) of GSK2118436 and Metabolites, and GSK1120212 After a Single and Repeat Dose|Trough concentration is the lowest level that a drug is present in the body. Pre-dose (trough) blood samples were collected on Day 8, Day 15, Weeks 3, 8, 16 and 24 for estimating plasma trough concentration. GSK2118436 metabolites included GSK2285403, GSK2298683, and GSK2167542. Ctau was determined from the raw concentration-time data.|At pre-dose on Day 8, Day 15, Weeks 3, 8, 16 and 24|PK Population.Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).||ng/mL||Geometric Coefficient of Variation|Geometric Mean
656954|NCT01928940|Secondary|Phase I: Maximum Plasma Concentration (Cmax) of GSK2118436 and Metabolites, and GSK1120212 After a Single and Repeat Dose|Blood samples were collected from each participant at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hr after administration of GSK2118436 + GSK1120212 on Day 1 (single dose) and at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hr post-dose on Day 21 (repeat dose) for PK analysis. GSK2118436 metabolites included GSK2285403, GSK2298683 and GSK2167542. Cmax was determined from the raw concentration-time data.|At pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hr after administration of GSK2118436 + GSK1120212 on Day 1 (single dose) and at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hr on Day 21 (repeat dose)|PK Population||ng/mL||Geometric Coefficient of Variation|Geometric Mean
656955|NCT01928940|Secondary|Phase I: Area Under the Plasma Concentration Versus Time Curve (AUC) of GSK2118436 and Metabolites, and GSK1120212 After Single and Repeat Dose|Blood samples were collected from each par. at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hr after administration of GSK2118436 + GSK1120212 on Day 1 (single dose) and at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hr post-dose on Day 21 (repeat dose) for PK analysis. GSK2118436 metabolites included GSK2285403, GSK2298683, and GSK2167542. AUC from time zero to last quantifiable concentration (concn) (AUC[0-t]) was determined using the linear trapezoidal rule for increasing concn and the logarithmic trapezoidal rule for decreasing. The AUC from time zero extrapolated to infinity (AUC[0-inf] was calculated, where data permit, as the sum of AUC(0-t) and Ct/z, where Ct is the observed plasma concn obtained from the log-linear regression analysis of the last quantifiable time-point and z is the terminal phase rate constant. Area under the concentration-time curve over 12 hr and 24 hr dosing interval is called AUC[0-12] and AUC[0-24]. AUC(0-inf) was calculated only at Day 1.|At pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hr after administration of GSK2118436 + GSK1120212 on Day 1 (single dose) and at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hr on Day 21 (repeat dose)|PK Population: all par. included in the ATS population for whom a PK sample was obtained and analyzed. Only those par. available at the specified time points were analyzed (represented by n=X in the category titles).||hr*nanogram (ng)/mL||Geometric Coefficient of Variation|Geometric Mean
656956|NCT01928940|Primary|Phase II: Number of Participant With Confirmed Overall Response|"Confirmed overall response (ORR) is defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. RECIST is a set of rules that define when tumors in cancer participants improve (respond), stay the same (stabilize), or worsen (progress) during treatment. CR is defined as disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions after treatment from Baseline (before study drug administration). ORR was assessed by investigator and blinded independent central review (BICR)."|Every 8 weeks from start of the treatment until disease progression, death, or withdrawal of consent (average of 1.38 years)|ATS Population||Participants|||Number
656957|NCT01928940|Primary|Phase I: Number of Participants With Worst-case On-therapy Change From Baseline in Left Ventricular Ejection Fraction (LVEF) as Assessed by Echocardiogram (ECHO)|Absolute change from Baseline in LVEF were summarized at each scheduled assessment time and in the worst-case post Baseline. Only the post Baseline assessments that used the same method (ECHO or Multi Gated Acquisition Scan [MUGA]) as the Baseline assessments were used to derive the change from Baseline. The change from Baseline was categorized as: any increase; no change; 0-<10 Decrease, 10-19 Decrease, >=20 Decrease, >=10 Decrease and >= lower limit of normal (LLN), >=10 Decrease and below LLN, >=20 Decrease and >=LLN and >=20 Decrease and below LLN. The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments.|From Baseline until the post-treatment Visit (average of 1.38 years)|ATS Population||Participants|||Number
656977|NCT01928927|Secondary|Change in Waist-to-hip Ratio From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.
Additionally, have non-missing waist-to-hip ratio."||waist cm : hip cm||Inter-Quartile Range|Median
656958|NCT01928940|Primary|Phase I: Number of Participants With the Indicated Electrocardiogram (ECG) Findings at the Indicated Time Points|Single twelve (12)-lead ECGs were perfomred at Baseline, Weeks 3 to 132 and post-treatment Visit. ECG findings were categorized as: normal, abnormal - clinically significant (CS), or abnormal - not clinically significant (NCS), as determined by the investigator.|From Baseline until the post-treatment Visit (average of 1.38 year)|ATS Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).||Participants|||Number
656959|NCT01928940|Primary|Phase I: Change From Baseline in Weight at the Indicated Time Points|Mean change in body weight from Baseline was determined. Change from Baseline was calculated as the individual post-Baseline value (Weeks 3 to 136 and post-treatment Visit) minus the Baseline value. The Baseline value is defined as the last pre-treatment value observed.|From Baseline until the post-treatment Visit ( average of 1.38 year)|ATS Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).||Kilogram (Kg)||Standard Deviation|Mean
656960|NCT01928940|Primary|Phase I: Change From Baseline in Oxygen Saturation (SpO2) Measured Via Pulse Oxymetry at the Indicated Time Points|Oxygen saturation measures the capacity of blood to transport oxygen to other parts of the body. Oxygen binds to hemoglobin in red blood cells when moving through the lungs. A pulse oximeter uses two frequencies of light (red and infrared) to determine the percentage of hemoglobin in the blood that is saturated with oxygen,that is called as blood oxygen saturation or SpO2. Change from Baseline was calculated as the individual post-Baseline value (Days 8,15; Weeks 3 to 136 and post-treatment Visit) minus the Baseline value. The Baseline value is defined as the last pre-treatment value observed.|From Baseline until the post-treatment Visit (average of 1.38 year)|ATS Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).||Percentage of oxygen in blood||Standard Deviation|Mean
656961|NCT01928940|Primary|Phase I: Number of Participants With Worst-case On-therapy Change From Baseline in Temperature|Change from Baseline in temperature is categorized as a decrease to <=35 degrees celsius (C), change to normal or no change as 35-38 degrees C, and increase to >=38 degrees C relative to the Baseline value. Participants with a missing Baseline value are assumed to have a normal Baseline value. Participants were counted twice if the participant temperature value decreased to <=35 degrees C and increased to >=38 degrees C post-Baseline. The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments.|From Baseline until the post-treatment Visit (average of 1.38 years)|ATS Population||Participants|||Number
656962|NCT01928940|Primary|Phase I: Number of Participants With Worst-case On-therapy Change From Baseline in Heart Rate|Change from Baseline in heart rate is categorized as decrease to <60 beats per minute (bpm), change to normal or no change, and increase to >100 bpm relative to the Baseline value. Participants with a missing Baseline value are assumed to have a normal Baseline value. Participants were counted twice if the participant's heart rate value decreased to <60 bpm and increased to >100 bpm post-Baseline. The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments.|From Baseline until the post-treatment Visit (average of 1.38 year)|ATS Population||Participants|||Number
656963|NCT01928940|Primary|Phase I: Number of Participants With Worst-case On-therapy Increase From Baseline in Systolic and Diastolic Blood Pressure to Grade 2 or Grade 3|Systolic blood pressure (SBP) and diastolic blood pressure (DBP) values were graded using (NCI CTCAE version 4.0). SBP was categorized as: G1 (Increase to >=120 to 140 millimeters of mercury [mmHg]), G2 (Increase to >=140 to <160 mmHg), and G3 (Increase to >=160 mmHg). DBP was categorized as: G1 (Increase to >=80 to <90 mmHg), G2 (Increase to >=90 to <100 mmHg), and G3 (Increase to >=100 mmHg). The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments. An increase is defined as an increase in the CTCAE grade relative to the Baseline grade. Participants with missing Baseline values were assumed to have a Baseline value of G0.|From Baseline until the post-treatment Visit (average of 1.38 year)|ATS Population||Participants|||Number
656964|NCT01928940|Primary|Phase I: Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance (Pef) Status|The ECOG pef status 5-point scale is used to assess how a participant's disease is progressing, to assess how the disease affects the daily living abilities of the par. and to determine appropriate treatment and prognosis: G0, fully active, able to carry on all pre-disease pef without restriction. G1, restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, example, light house work, office work. G2, ambulatory and capable of all selfcare, but unable to carry out any work activities; up and about >50 percent (%) of waking hrs. G3, capable of only limited selfcare; confined to bed or chair >50% of waking hrs. G4, completely disabled; cannot carry on any selfcare; totally confined to bed or chair. G5, dead. The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments. Number of par. who improved, had no change, or deteriorated in pef status from BL is summarized.|From Baseline until the post-treatment Visit (average of 1.38 year)|ATS Population||Participants|||Number
656965|NCT01928940|Primary|Phase I: Number of Participants With the Indicated Urinalysis Parameters|Urine samples were collected for urine dipstick analysis at Baseline and at the post-treatment Visit. The number of participants with negative (absence) and positive (presence: trace, 1+, 2+, 3+, 4+ or 5+) results for urine occult blood (UOB), urine glucose (UGLU), urine ketones (UKET), urine protein (UP) and urine urobilinogen (UUBIL) were summarized. The Baseline value is defined as the last pre-treatment value observed.|From Baseline until the post-treatment Visit (average of 1.38 year)|ATS Population||Participants|||Number
656978|NCT01928927|Secondary|Change in Waist-to-hip Ratio From Baseline to Week 24|Absolute change was calculated as the value at week 24 minus the value at baseline.|baseline and week 24|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.
Additionally, have non-missing waist-to-hip ratio."||waist cm : hip cm||Inter-Quartile Range|Median
656979|NCT01928927|Secondary|Change in Waist Circumference From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.
Additionally, have non-missing waist circumference."||cm||Inter-Quartile Range|Median
656966|NCT01928940|Primary|Phase I: Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Hematology Parameters|Hematology parameters were summarized according to NCI CTCAE G, version 4.0 as: G1, Mild; G2, Moderate; G3, Severe; G4, Life-threatening or disabling; G5, Death. Data are presented for only those parameters for which an increase to G3 or G4 from Baseline G occurred. For hematology parameters that were not graded according to NCI CTCAE criteria, were categorized as High and Low with respect to the normal range. Data are presented only for those parameters for which the category decreased to Low or increased to High relative to the Baseline category. The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments. Hematology parameters included: hemoglobin, lymphocytes, total neutrophils, platelet count, white blood cell (WBC) counts, basophils, eosinophils, hematocrit, mean corpuscular hemoglobin concentration (MCHC), mean corpuscular hemoglobin (MCH), mean corpuscular volume (MCV), monocytes and red blood cell (RBC) count.|From Baseline until the post-treatment Visit (average of 1.38 year)|ATS Population||Participants|||Number
656967|NCT01928940|Primary|Phase I: Number of Participants With the Indicated Worst-case Change From Baseline (BL) in the Indicated Clinical Chemistry Parameters (CCPs)|CCPs were graded according to NCI CTCAE grade version 4.0 as: G1, Mild; G2, Moderate; G3, Severe; G4, Life-threatening or disabling; G5, Death. Data are presented for only those parameters (para) for which an increase to G3 or G4 from BL G occurred. CCPs that were not G according to NCI CTCAE criteria, were categorized as High and Low with respect to the normal range. Data are presented only for those para for which the category decreased to Low or increased to High relative to the BL category. The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments. CCPs included: albumin, alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, calcium, creatinine, glucose, potassium, magnesium, sodium, inorganic phosphorus, chloride, lactate dehydrogenase (LDH), total protein, urea/blood urea nitrogen (BUN) and uric acid.|From Baseline until the post-treatment Visit (average of 1.38 year)|ATS Population||Participants|||Number
656968|NCT01928940|Primary|Phase I: Number of Participants With a Dose-limiting Toxicity (DLT)|A DLT was defined as an event occurred during the first 21 days after the first dose of study drugs and met any of the following criteria, according to National Cancer Institutes (NCI) common terminology criteria for AE (CTCAE) grade (G) version 4.0: G4 hematological toxicity; G3 or G4 non-hematologic toxicity (including rash, nausea, vomiting and diarrhea only if uncontrolled with supportive therapy); rash >=G3 that required dose reduction despite supportive care; a G2 or greater non-hematological toxicity that in the judgment of the investigator and medical monitor; dose interruption of greater than 14 consecutive days due to unresolved toxicity; any new G2 or greater valvular heart disease and significant alteration in cardiac valve morphology from Baseline.|From the start of study treatment until 21 days|DLT assessment Population: all participants for whom DLT assessment was appropriately conducted||Participants|||Number
656969|NCT01928940|Primary|Phase I: Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence (MO) in a part. temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. SAE is defined as any untoward MO that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, a congenital anomaly/birth defect and protocol-specific SAEs:ALT>=3xupper limit of normal(ULN) and bilirubin>=2xULN(>35% direct) (or ALT>=3xULN, international normalized ratio>1.5), any new primary cancers, treatment emergent malignancies except basal cell carcinoma, symptomatic or asymptomatic LVEF decrease, retinal pigment epithelial detachment or retinal vein occlusion, pyrexia with hypotension,or dehydration or renal insufficiency,or severe (>=G3) rigor/chills.|From the start of study treatment until 30 days after study treatment discontinuation (average of 1.38 year)|All Treated Subject (ATS) Population: all participants who received at least one dose of study medication.||Participants|||Number
656970|NCT01928927|Secondary|Change in the Proportion of CD4+ T Cells in Lymphoid Tissue From Baseline to Week 48.|Measured as the change from entry to week 48 in %CD3+CD4+ T cells.|48 weeks||11/2017||||
656971|NCT01928927|Secondary|Change in Inflammatory Cell Population Type and Number in Adipose Tissue Biopsy Specimens From Baseline to Week 48|Measured as the change from entry to week 48 in the frequency of CD14+, CD16+,CD64+, and/or CD163+ macrophages.|48 weeks||11/2017||||
656972|NCT01928927|Secondary|Change in Inflammatory Cell Population Type and Number in Lymphoid Tissue Biopsy Specimens From Baseline to Week 48|Measured as the change from entry to week 48 in the frequency of CD14+, CD16+,CD64+, and/or CD163+ macrophages and % activated (CD38+/HLA-DR+, Ki67+) CD4 and CD8 T cells.|48 weeks||11/2017||||
656973|NCT01928927|Secondary|Change in Expression of CD38+HLA-DR+ on CD8+ From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|48 weeks|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.
Additionally, have non-missing CD8+CD38+HLA-DR+ data."||Percent of CD8+ expressing CD38+HLA-DR+||Inter-Quartile Range|Median
656974|NCT01928927|Secondary|Change in Expression of CD38+HLA-DR+ on CD4+ From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|48 weeks|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.
Additionally, have non-missing CD4+CD38+HLA-DR+ data."||Percent of CD4+ expressing CD38+HLA-DR+||Inter-Quartile Range|Median
656975|NCT01928927|Secondary|Change in Expression of CD38+HLA-DR+ on CD8+ From Baseline to Week 24|Absolute change was calculated as the value at week 24 minus the value at baseline.|24 weeks|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.
Additionally, have non-missing CD8+CD38+HLA-DR+ data."||Percent of CD8+ expressing CD38+HLA-DR+||Inter-Quartile Range|Median
656976|NCT01928927|Secondary|Change in Expression of CD38+HLA-DR+ on CD4+ From Baseline to Week 24|Absolute change was calculated as the value at week 24 minus the value at baseline.|24 weeks|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.
Additionally, have non-missing CD4+CD38+HLA-DR+ data."||Percent of CD4+ expressing CD38+HLA-DR+||Inter-Quartile Range|Median
656981|NCT01928927|Secondary|Presence of Metabolic Syndrome at Week 48.|"Components of the metabolic syndrome were defined according to the 2004 updated National Cholesterol Education Program Adult Treatment Panel III [NCEP ATP III] criteria) as the presence of any 3 of the following: Waist: >40 (101.6 cm) in men, >35 (88.9 cm) in women with the exception of Asian-Americans: >35 (88.9 cm) in men, 31 (78.7 cm) in women; Fasting HDL-C <40 mg/dL in men, <50 mg/dL in women; Fasting TG ≥150 mg/dL; Diastolic blood pressure ≥85 mmHg or systolic blood pressure ≥130 mmHg; Fasting plasma glucose ≥100 mg/dL."|Week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.
Additionally, have non-missing metabolic syndrome components."||Participants|||Count of Participants
656982|NCT01928927|Secondary|Prevalence of Metabolic Syndrome at Week 24.|"Components of the metabolic syndrome will be defined according to the 2004 updated National Cholesterol Education Program Adult Treatment Panel III [NCEP ATP III] criteria) as the presence of any 3 of the following: Waist: >40 (101.6 cm) in men, >35 (88.9 cm) in women with the exception of Asian-Americans: >35 (88.9 cm) in men, 31 (78.7 cm) in women; Fasting HDL-C <40 mg/dL in men, <50 mg/dL in women; Fasting TG ≥150 mg/dL; Diastolic blood pressure ≥85 mmHg or systolic blood pressure ≥130 mmHg; Fasting plasma glucose ≥100 mg/dL.
NOTE: This definition of metabolic syndrome may be subject to change in accordance with current guidelines at the time of the final analysis. It will be defined in the Final Statistical Analysis Plan prior to data review for final analysis."|Week 24|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.
Additionally, have non-missing metabolic syndrome components."||Participants|||Count of Participants
656983|NCT01928927|Secondary|Change in HOMA-IR From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.
Additionally, have non-missing HOMA-IR."||(mg/dl)x(uIU/ml)/405||Inter-Quartile Range|Median
656984|NCT01928927|Secondary|Change in Fasting Triglycerides From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.
Additionally, have non-missing fasting triglycerides."||mg/dl||Inter-Quartile Range|Median
656985|NCT01928927|Secondary|Change in Fasting Total Cholesterol From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.
Additionally, have non-missing fasting total cholesterol."||mg/dl||Inter-Quartile Range|Median
656986|NCT01928927|Secondary|Change in Fasting LDL Cholesterol From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.
Additionally, have non-missing fasting LDL cholesterol."||mg/dl||Inter-Quartile Range|Median
656987|NCT01928927|Secondary|Change in Fasting Insulin From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.
Additionally, have non-missing fasting insulin."||uIU/ml||Inter-Quartile Range|Median
656988|NCT01928927|Secondary|Change in Fasting HDL Cholesterol From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.
Additionally, have non-missing fasting HDL cholesterol."||mg/dl||Inter-Quartile Range|Median
656989|NCT01928927|Secondary|Change in Fasting Glucose From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.
Additionally, have non-missing fasting glucose."||mg/dl||Inter-Quartile Range|Median
656990|NCT01928927|Secondary|Change in Circulating CD8+ T Cell Count From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.
Additionally, have non-missing CD8+ count."||cells/mm^3||Inter-Quartile Range|Median
656991|NCT01928927|Secondary|Change in Circulating CD8+ T Cell Count From Baseline to Week 24|Absolute change was calculated as the value at week 24 minus the value at baseline.|baseline and week 24|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.
Additionally, have non-missing CD8+ count."||cells/mm^3||Inter-Quartile Range|Median
656992|NCT01928927|Secondary|Change in Circulating CD8+ T Cell Count From Baseline to Week 12|Absolute change was calculated as the value at week 12 minus the value at baseline.|baseline and week 12|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.
Additionally, have non-missing CD8+ count."||cells/mm^3||Inter-Quartile Range|Median
656993|NCT01928927|Secondary|Change in Circulating CD4+ T Cell Count From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.
Additionally, have non-missing CD4+ count."||cells/mm^3||Inter-Quartile Range|Median
656996|NCT01928927|Secondary|Change in TGF-β3 From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.
Additionally, have non-missing TGF-β3."||pg/ml||Inter-Quartile Range|Median
656997|NCT01928927|Secondary|Change in TGF-β3 From Baseline to Week 24|Absolute change was calculated as the value at week 24 minus the value at baseline.|baseline and week 24|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.
Additionally, have non-missing TGF-β3."||pg/ml||Inter-Quartile Range|Median
656998|NCT01928927|Secondary|Change in TGF-β3 From Baseline to Week 4|Absolute change was calculated as the value at week 4 minus the value at baseline.|baseline and week 4|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.
Additionally, have non-missing TGF-β3."||pg/ml||Inter-Quartile Range|Median
656999|NCT01928927|Secondary|Change in TGF-β2 From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.
Additionally, have non-missing TGF-β2."||pg/ml||Inter-Quartile Range|Median
657000|NCT01928927|Secondary|Change in TGF-β2 From Baseline to Week 24|Absolute change was calculated as the value at week 24 minus the value at baseline.|baseline and week 24|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.
Additionally, have non-missing TGF-β2."||pg/ml||Inter-Quartile Range|Median
657001|NCT01928927|Secondary|Change in TGF-β2 From Baseline to Week 4|Absolute change was calculated as the value at week 4 minus the value at baseline.|baseline and week 4|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.
Additionally, have non-missing TGF-β2."||pg/ml||Inter-Quartile Range|Median
657002|NCT01928927|Secondary|Change in TGF-β1 From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.
Additionally, have non-missing TGF-β1."||pg/ml||Inter-Quartile Range|Median
657003|NCT01928927|Secondary|Change in TGF-β1 From Baseline to Week 24|Absolute change was calculated as the value at week 24 minus the value at baseline.|baseline and week 24|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.
Additionally, have non-missing TGF-β1."||pg/ml||Inter-Quartile Range|Median
657004|NCT01928927|Secondary|Change in TGF-β1 From Baseline to Week 4|Absolute change was calculated as the value at week 4 minus the value at baseline.|baseline and week 4|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.
Additionally, have non-missing TGF-β1."||pg/ml||Inter-Quartile Range|Median
657005|NCT01928927|Secondary|Change in sCD163 From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.
Additionally, have non-missing sCD163."||ng/ml||Inter-Quartile Range|Median
657006|NCT01928927|Secondary|Change in sCD163 From Baseline to Week 24|Absolute change was calculated as the value at week 24 minus the value at baseline.|baseline and week 24|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.
Additionally, have non-missing sCD163."||ng/ml||Inter-Quartile Range|Median
657007|NCT01928927|Secondary|Change in sCD163 From Baseline to Week 4|Absolute change was calculated as the value at week 4 minus the value at baseline.|baseline and week 4|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.
Additionally, have non-missing sCD163."||ng/ml||Inter-Quartile Range|Median
657008|NCT01928927|Secondary|Change in sCD14 From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.
Additionally, have non-missing sCD14."||mcg/ml||Inter-Quartile Range|Median
657009|NCT01928927|Secondary|Change in sCD14 From Baseline to Week 24|Absolute change was calculated as the value at week 24 minus the value at baseline.|baseline and week 24|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.
Additionally, have non-missing sCD14."||mcg/ml||Inter-Quartile Range|Median
657010|NCT01928927|Secondary|Change in sCD14 From Baseline to Week 4|Absolute change was calculated as the value at week 4 minus the value at baseline.|baseline and week 4|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.
Additionally, have non-missing sCD14."||mcg/ml||Inter-Quartile Range|Median
657011|NCT01928927|Secondary|Change in Hyaluronic Acid From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.
Additionally, have non-missing hyaluronic acid."||ng/ml||Inter-Quartile Range|Median
657012|NCT01928927|Secondary|Change in Hyaluronic Acid From Baseline to Week 24|Absolute change was calculated as the value at week 24 minus the value at baseline.|baseline and week 24|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.
Additionally, have non-missing hyaluronic acid."||ng/ml||Inter-Quartile Range|Median
657013|NCT01928927|Secondary|Change in Hyaluronic Acid From Baseline to Week 4|Absolute change was calculated as the value at week 4 minus the value at baseline.|baseline and week 4|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.
Additionally, have non-missing hyaluronic acid."||ng/ml||Inter-Quartile Range|Median
657014|NCT01928927|Secondary|Change in Collagen I C-terminal Pro-peptide (CICP) From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.
Additionally, have non-missing CICP."||ng/ml||Inter-Quartile Range|Median
657015|NCT01928927|Secondary|Change in Collagen I C-terminal Pro-peptide (CICP) From Baseline to Week 24|Absolute change was calculated as the value at week 24 minus the value at baseline.|baseline and week 24|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.
Additionally, have non-missing CICP."||ng/ml||Inter-Quartile Range|Median
657016|NCT01928927|Secondary|Change in Collagen I C-terminal Pro-peptide (CICP) From Baseline to Week 4|Absolute change was calculated as the value at week 4 minus the value at baseline.|baseline and week 4|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.
Additionally, have non-missing CICP."||ng/ml||Inter-Quartile Range|Median
657017|NCT01928927|Secondary|Change in Adiponectin From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.
Additionally, have non-missing adiponectin."||ng/ml||Inter-Quartile Range|Median
657018|NCT01928927|Secondary|Change in Adiponectin From Baseline to Week 24|Absolute change was calculated as the value at week 24 minus the value at baseline.|baseline and week 24|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.
Additionally, have non-missing adiponectin."||ng/ml||Inter-Quartile Range|Median
657019|NCT01928927|Secondary|Change in Adiponectin From Baseline to Week 4|Absolute change was calculated as the value at week 4 minus the value at baseline.|baseline and week 4|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.
Additionally, have non-missing adiponectin."||ng/ml||Inter-Quartile Range|Median
657020|NCT01928927|Secondary|Change in IL-7 From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.
Additionally, have non-missing IL-7."||pg/ml||Inter-Quartile Range|Median
657021|NCT01928927|Secondary|Change in IL-7 From Baseline to Week 24|Absolute change was calculated as the value at week 24 minus the value at baseline.|baseline and week 24|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.
Additionally, have non-missing IL-7."||pg/ml||Inter-Quartile Range|Median
657022|NCT01928927|Secondary|Change in IL-7 From Baseline to Week 4|Absolute change was calculated as the value at week 4 minus the value at baseline.|baseline and week 4|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.
Additionally, have non-missing IL-7."||pg/ml||Inter-Quartile Range|Median
657023|NCT01928927|Secondary|Change in IL-6 From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.
Additionally, have non-missing IL-6."||pg/ml||Inter-Quartile Range|Median
657024|NCT01928927|Secondary|Change in IL-6 From Baseline to Week 24|Absolute change was calculated as the value at week 24 minus the value at baseline.|baseline and week 24|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.
Additionally, have non-missing IL-6."||pg/ml||Inter-Quartile Range|Median
657025|NCT01928927|Secondary|Change in IL-6 From Baseline to Week 4|Absolute change was calculated as the value at week 4 minus the value at baseline.|baseline and week 4|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.
Additionally, have non-missing IL-6."||pg/ml||Inter-Quartile Range|Median
657026|NCT01928927|Secondary|Highest Grade Non-biopsy-related Adverse Event|"Safety was summarized as the highest grade non-biopsy-related sign/symptom, laboratory event, or diagnosis per participant.
Grading (Grade 0: normal, Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life-threatening) was done by site clinicians using DAIDS AE Grading table.
NOTE: As adipose tissue and lymph node biopsies are generally considered to be minimal risk procedures, biopsy safety profile were not formally be evaluated as an endpoint in this protocol."|after baseline to week 48|All Step 2 participants||Participants|||Count of Participants
657103|NCT01928186|Secondary|Post-therapy Ki (Flux Constant) Values by FLT PET|Ki (flux constant) in breast tumor tissue as determined by the post-therapy FLT PET|1 to 6 weeks post-therapy start|||mL/min/mL||Full Range|Median
657027|NCT01928927|Secondary|Change in Percent Collagen VI Deposition on Subcutaneous Abdominal Adipose Tissue Pathology From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.
Additionally, have non-missing adipose collagen VI deposition."||percent area stain positive||Inter-Quartile Range|Median
657028|NCT01928927|Secondary|Change in Percent Fibronectin Deposition on Subcutaneous Abdominal Adipose Tissue Pathology From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.
Additionally, have non-missing adipose tissue fibronectin deposition."||percent area stain positive||Inter-Quartile Range|Median
657029|NCT01928927|Secondary|Change in Percent Fibronectin Deposition on Lymph Node Pathology From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.
Additionally, have non-missing lymphoid tissue fibronectin deposition."||percent area stain positive||Inter-Quartile Range|Median
657030|NCT01928927|Primary|Change in Percent Collagen I Deposition on Subcutaneous Abdominal Adipose Tissue Pathology From Baseline to Week 48|Percent collagen I deposition defined as percentage of fibrotic/collagen area to total area. Change was absolute change defined as the Week 48 value minus the baseline value.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.
Additionally, have non-missing subcutaneous abdominal adipose tissue collagen I deposition."||percent area stain positive||Inter-Quartile Range|Median
657031|NCT01928927|Primary|Change in Percent Collagen I Deposition on Lymph Node Pathology From Baseline to Week 48|Percent collagen I deposition is defined as the average % collagen stained in multiple uniform sized high magnification images in each sample. Change was absolute change defined as the Week 48 value minus the baseline value.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.
Additionally, have non-missing lymphoid tissue collagen I deposition."||percent area stain positive||Inter-Quartile Range|Median
657032|NCT01928797|Secondary|Number of Participants With Umbilical Cord pH|Number of participants with Umbilical cord pH <7.2|Intraoperative|1 out of 30 babies had umbilical pH < 7.2||number of participants|||Number
657033|NCT01928797|Secondary|Nausea and Vomiting|incidence of nausea, and vomiting|intraoperatively during surgery|Nausea||Participants|||Count of Participants
657034|NCT01928797|Primary|Mean Cardiac Output|"To determine mean cardiac output differences between the control group and the study group that used cardiac output data. In the control group, the cardiac output data was measured but not used for correcting blood pressure changes. Blood pressure changes were used for administering phenylephrine or ephedrine. In the study group, cardiac output data was used, in addition to blood pressure data, to correct both cardiac output and blood pressures to be maintained within 20% of baseline measurements.
After spinal anesthesia for cesarean delivery, the cardiac output and blood pressure tends to decrease. When this occurs, the blood flow to the uterus and the baby decrease resulting in fetal heart changes. Since we do not monitor the baby during the actual cesarean delivery (technically difficult), the strategy is to maintain the blood pressure and cardiac output within the 20% of the baseline values."|intraoperatively during surgery|||percentage of patients|||Number
657035|NCT01928771|Secondary|Patient and Clinician's Responder Assessment to Treatment|CGIC (Clinical global impression of change), and PGIC (Patient global impression of change) are overall evaluation of response to treatment, conducted separately by investigator and patient using 7-point rating scale, ranging from 1 (very much improved), to 7 (very much worse). This is additional measures collected after second Amendment, thus not all patients had data to be analyzed.|Immediately following the first administration of study drug through Study Week 48|Full analysis set, Baseline eosinophils >=300/uL||Participants|||Number
657036|NCT01928771|Secondary|Number of Participants That Utilized Health Care Resources||Immediately following the first administration of study drug through Study Week 48.|Full analysis set, Baseline eosinophils >=300=/uL||Participants|||Number
657037|NCT01928771|Secondary|Mean Productivity Loss Due to Asthma in Classroom|WPAI+CIQ (Work Productivity and Activity Impairment plus Classroom Impairment Questionnaire) contains 10 questions. Classroom productivity loss is derived by sum of percentage of missed classes due to asthma and product of percentage of actual hours attending classes times degree of asthma affecting classroom productivity. Percentage of missed classes due to asthma is calculated by number of hours missed classes due to asthma divided by total number of hours missed classes plus number of hours actually attending classes. This is only applicable to patients who attending classes|Immediately following the first administration of study drug through Study Week 48.|Full analysis set, Baseline eosinophils >=300/uL who attending classes||Percent of productivity loss||Standard Deviation|Mean
657038|NCT01928771|Secondary|Mean Work Productivity Loss Due to Asthma|WPAI+CIQ (Work Productivity and Activity Impairment plus Classroom Impairment Questionnaire) contains 10 questions. Work productivity loss is derived by sum of percentage of missed work due to asthma and product of percentage of actual working hours times degree of asthma affecting work productivity while working. Percentage of missed work due to asthma is calculated by number of hours missed work due to asthma divided by total number of hours missed work plus number of hours actually worked. The work productivity loss is only applicable to patients who employed, which is only subset of the study population.|Immediately following the first administration of study drug through Study Week 48.|Full analysis set, Baseline eosinophils >=300/uL for patients who employed||Percent of productivity loss||Standard Deviation|Mean
657039|NCT01928771|Secondary|Mean Change From Baseline to Week 48 in EQ-5D-5L VAS|EQ-5D-5L VAS is to rate current health status on a scale of 0-100, with 0 being the worst imaginable health state.|Immediately following the first administration of study drug through Study Week 48.|Full analysis set, Baseline eosinophils >=300/uL||Scores on a scale||Standard Deviation|Mean
657040|NCT01928771|Secondary|Mean Change From Baseline to Week 48 in AQLQ(S)+12|AQLQ(S)+12 overall score is defined as the average of all 32 questions in the AQLQ(S)+12 questionnaire. AQLQ(S)+12 is a 7-point scale questionnaire, ranging from 7 (no impairment) to 1 (severe impairment). Total or domain score change of >=0.5 are considered clinically meaningful.|Immediately following the first administration of study drug through Study Week 48.|Full analysis set, Baseline eosinophils >=300/uL||Scores on a scale||Standard Deviation|Mean
657041|NCT01928771|Secondary|Extend of Exposure|Extend of exposure is defined as duration of treatment in days|Immediately following the first administration of study drug through Study Week 48.|Safety analysis set, note that 4 patients who were randomized to q.8 regimen treated with q.4 regimen. Thus 403 patients treated with q.4 rather than 399, 394 patients treated with q.8 rather than 398.||Days||Standard Deviation|Mean
657042|NCT01928771|Secondary|Immunogenicity of Benralizumab|Anti-drug antibodies (ADA) responses at baseline and post baseline. Persistently positive is defined as positive at >=2 post baseline assessments (with >=16 weeks between the first and the last positive) or positive at last post baseline assessment. Transiently positive is defined as having at least one post baseline ADA positive assessment and not fulfilling the conditions of persistently positive.|Pre-treatment until end of follow-up|Safety analysis set, note that 4 patients who were randomized to q.8 regimen treated with q.4 regimen. Thus 403 patients treated with q.4 rather than 399, 394 patients treated with q.8 rather than 398. However, data were only available for 402 patients in q.4, and 393 patients in q.8.||Participants|||Number
657043|NCT01928771|Secondary|Pharmacokinetics of Benralizumab|Mean PK concentrations at each visit|Baseline, week 4, week 4 day 6, week 8, week 16, week 24, week 32, week 40, week 48, week 56|PK analysis set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
657044|NCT01928771|Secondary|Mean Change From Baseline to Week 48 in ACQ-6 for Baseline Eosinophils <300/uL|ACQ-6 contains one bronchodilator question and 5 symptom questions. Questions are rated from 0 (totally controlled) to 6 (severely uncontrolled). Mean ACQ-6 score is the average of the responses. Mean scores of <=0.75 indicates well-controlled asthma, scores between 0.75 to <=1.5 indicate partly controlled asthma, and >1.5 indicates not well controlled asthma.|Immediately following the first administration of study drug through Study Week 48.|Full analysis set, Baseline eosinophils <300/uL||Scores on a scale||Standard Deviation|Mean
657045|NCT01928771|Secondary|Mean Change From Baseline to Week 48 in ACQ-6 for Baseline Eosinophils >=300/uL|ACQ-6 contains one bronchodilator question and 5 symptom questions. Questions are rated from 0 (totally controlled) to 6 (severely uncontrolled). Mean ACQ-6 score is the average of the responses. Mean scores of <=0.75 indicates well-controlled asthma, scores between 0.75 to <=1.5 indicate partly controlled asthma, and >1.5 indicates not well controlled asthma.|Immediately following the first administration of study drug through Study Week 48.|Full analysis set, Baseline eosinophils >=300/uL||Scores on a scale||Standard Deviation|Mean
657046|NCT01928771|Secondary|Proportion of Night Awakening Due to Asthma|Change from baseline to Week 48 on proportion of night awakening due to asthma|Immediately following the first administration of study drug through Study Week 48.|Full analysis set, Baseline eosinophils >=300/uL||Proportion of nights||Standard Deviation|Mean
657047|NCT01928771|Secondary|Home Lung Function Assessment Based on Evening PEF|Change from baseline to week 48 in home lung function evening peak expiratory flow [PEF]|Immediately following the first administration of study drug through Study Week 48.|Full analysis set, Baseline eosinophils >=300/uL||L/min||Standard Deviation|Mean
657048|NCT01928771|Secondary|Home Lung Function Assessment Based on Morning PEF|Change from baseline to week 48 in home lung function morning peak expiratory flow [PEF]|Immediately following the first administration of study drug through Study Week 48.|Full analysis set, Baseline eosinophils >=300/uL||L/min||Standard Deviation|Mean
657049|NCT01928771|Secondary|Change in Asthma Rescue Medication|Change from baseline to week 48 in number of rescue medication use (puffs/day)|Immediately following the first administration of study drug through Study Week 48.|Full analysis set, Baseline eosinophils >=300/uL||Puffs/day||Standard Deviation|Mean
657050|NCT01928771|Secondary|Mean Change From Baseline to Week 48 in Asthma Symptom Score for Baseline Eosinophils <300/uL|Asthma symptoms during night time and daytime are recorded by the patient in the asthma daily diary. Symptom score values are from 0 (No asthma symptom) to 3 (unable to sleep because of asthma, or unable to do normal activities due to asthma), and total asthma symptom score is the sum of the daytime and night time score (0 to 6). Lower score (0) is indicating better asthma symptom, while higher score (6) is indicating worse asthma symptom. Baseline is defined as the average of data collected from the evening of study day -10 to the morning of study day 1. Each time point is calculated as bi-weekly means based on daily diary data. If more than 50% of scores are missing in a 14 day period then this is considered as missing. Symptom score lower is better.|Immediately following the first administration of study drug through Study Week 48.|Full analysis set, Baseline eosinophils <300/uL||Scores on a scale||Standard Deviation|Mean
657051|NCT01928771|Secondary|Mean Change From Baseline to Week 48 in Asthma Symptom Score for Baseline Eosinophils >=300/uL|Asthma symptoms during night time and daytime are recorded by the patient in the asthma daily diary. Symptom score values are from 0 (No asthma symptom) to 3 (unable to sleep because of asthma, or unable to do normal activities due to asthma), and total asthma symptom score is the sum of the daytime and night time score (0 to 6). Lower score (0) is indicating better asthma symptom, while higher score (6) is indicating worse asthma symptom. Baseline is defined as the average of data collected from the evening of study day -10 to the morning of study day 1. Each time point is calculated as bi-weekly means based on daily diary data. If more than 50% of scores are missing in a 14 day period then this is considered as missing. Symptom score lower is better.|Immediately following the first administration of study drug through Study Week 48.|Full analysis set, Baseline eosinophils >=300/uL||Scores on a scale||Standard Deviation|Mean
657052|NCT01928771|Secondary|Mean Change From Baseline to Week 48 in Pre-bronchodilator FEV1 (L) Value for Baseline Eosinophils <300/uL||Immediately following the first administration of study drug through Study Week 48.|Full analysis set, Baseline eosinopiles <300/uL||Liter||Standard Deviation|Mean
657053|NCT01928771|Secondary|Mean Change From Baseline to Week 48 in Pre-bronchodilator FEV1 (L) Value for Baseline Eosinophils >=300/uL||Immediately following the first administration of study drug through Study Week 48.|Full analysis set, Baseline eosinopiles >=300/uL||Liter||Standard Deviation|Mean
657054|NCT01928771|Secondary|Time to First Asthma Exacerbation||Immediately following the first administration of study drug through Study Week 48.|Full analysis set, Baseline eosinophils >=300/uL||Days||95% Confidence Interval|Median
657057|NCT01928771|Secondary|Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Eosinophils < 300/uL|The annual exacerbation rate is based on unadjudicated annual exacerbation rate reported by the investigator in the eCRF|Immediately following the first administration of study drug through Study Week 48.|Full analysis set, Baseline eosinophils <300/uL||events/year||95% Confidence Interval|Least Squares Mean
657058|NCT01928771|Primary|Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Eosinophils >=300/uL|The annual exacerbation rate is based on unadjudicated annual exacerbation rate reported by the investigator in the eCRF|Immediately following the first administration of study drug through Study Week 48.|Full analysis set, Baseline eosinophils >=300/uL||events/year||95% Confidence Interval|Least Squares Mean
657059|NCT01928693|Other Pre-specified|Number of Participants With Treatment Failure||29 days|||participants|||Number
657060|NCT01928693|Other Pre-specified|Patient Pain Scores|Patients will be asked to grade the overall pain of the affected eye at each visit on a Scale= 0--None, 1- Mild, 2- Moderate, 3- Severe|Average of 6 times in a 29 day period|||units on a scale|||Number
657061|NCT01928693|Other Pre-specified|Patient Satisfaction Scores|Patient satisfaction outcomes will be assessed using a series of survey questions ranging in both categorical and continuous outcomes. Treatment will be compared using either methods for differences in binomial proportions or the Wilcoxon Rank Sum test. Scale= 0- Very Comfortable, 1- Comfortable, 2- Uncomfortable, 3- Very Uncomfortable|Average of 6 times in a 29 day period|||units on a scale|||Number
657062|NCT01928693|Other Pre-specified|Scarring|Scarring will be evaluated and measured in millimeters at Day 29 and classified as either peripheral or central.|29 days|||millimeters|||Number
657063|NCT01928693|Other Pre-specified|Time to Treatment Failure.|If there is no reduction in size of the corneal ulcer by day 8, the treatment will be deemed a failure and alternative medications will be given at the discretion of the investigator.|8 days|Data was not collected because there were no treatment failures in any of the treatment arms|||||
657064|NCT01928693|Secondary|Healing Rate|Time to corneal ulcer reduction and/or total healing over a treatment course of 21 days.|29 days|||Days|||Number
657065|NCT01928693|Primary|Complete Healing|The primary outcome will be complete healing of the corneal ulcer, defined as complete reepithelialization by Day 29.|29 days|||participant|||Number
657066|NCT01928680|Secondary|Number and Severity of Adverse Events of Patients Enrolled in This Trial|Number and severity of adverse events sufferred by patients who received capecitabine and cisplatin regimen.|1 year||||||
657067|NCT01928680|Secondary|Overall Survival||3 years||||||
657068|NCT01928680|Secondary|Progression Free Survival||2 years||||||
657069|NCT01928680|Primary|Overall Response Rate||6 months|||percentage of response|||Number
657070|NCT01928615|Secondary|Percentage of Participants Preferring Each Injection Site|Participants were asked which of the 2 injection sites was their preferred site at the end of Cycle 14.|End of Cycle 14 (Week 42)|"Intent-to-treat population: All participants who received at least 1 dose of study medication.
Due to the low enrollment (n = 2) and premature termination of the study, the Outcome Measure was not analyzed."|||||
657071|NCT01928615|Secondary|Participant’s Satisfaction With the Injection Site|Each participant was asked to rate their satisfaction with the 2 injection sites, thigh and upper arm, on a scale of 1 to 10, where 10 represents greater satisfaction. Ratings were made at the end of Cycles 10 and 14.|End of Cycles 10 and 14 (Weeks 30 and 42)|"Intent-to-treat population: All participants who received at least 1 dose of study medication.
Due to the low enrollment (n = 2) and premature termination of the study, the Outcome Measure was not analyzed."|||||
657072|NCT01928615|Secondary|Health Care Provider’s Satisfaction With the Injection Site|The health care provider for each participant was asked to rate their satisfaction with the 2 injection sites, thigh and upper arm, on a scale of 1 to 10, where 10 represents greater satisfaction. Ratings were made at the end of Cycles 10 and 14.|End of Cycles 10 and 14 (Weeks 30 and 42)|"Intent-to-treat population: All participants who received at least 1 dose of study medication.
Due to the low enrollment (n = 2) and premature termination of the study, the Outcome Measure was not analyzed."|||||
657073|NCT01928615|Secondary|Disease-free Survival|Disease-free survival was defined as the time in months from Baseline to disease recurrence or death, whichever occurred first.|Baseline to the end of the study (up to 54 weeks)|"Intent-to-treat population: All participants who received at least 1 dose of study medication.
Due to the low enrollment (n = 2) and premature termination of the study, the Outcome Measure was not analyzed."|||||
657074|NCT01928615|Secondary|Overall Survival|Overall survival was defined as the time in months from Baseline to death from any cause.|Baseline to the end of the study (up to 54 weeks)|"Intent-to-treat population: All participants who received at least 1 dose of study medication.
Due to the low enrollment (n = 2) and premature termination of the study, the Outcome Measure was not analyzed."|||||
657075|NCT01928615|Primary|Quality of Life Score|Participants rated their quality of life on a visual analog scale (VAS) at the end of each cycle for Cycles 7-14. The left-end of the VAS represented the lowest-rated quality of life and the right-end of the VAS represented the highest-rated quality of life. Both the mean ratings for injections into the thigh and the upper arm and the minimum ratings for during injections into the thigh and the upper arm are reported. Quality of life scores ranged from 1 to 100 with a higher score indicating a better rated quality of life.|Cycles 7-14 (Weeks 19-42, 24 weeks total)|"Modified intent-to-treat population: All participants who received at least 1 dose of study medication and who have at least 1 quality of life score in each treatment period (Cycles 7-10 and Cycle 11-14).
Due to the low enrollment (n = 2) and premature termination of the study, the Outcome Measure was not analyzed."|||||
657076|NCT01928472|Primary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine|Safety was assessed as the number of subjects who reported solicited local and systemic adverse events from day 1 to day 7 of vaccination of adjuvanted and unadjuvanted formulations of H7N9c vaccine.|Day 1 through Day 7 after each vaccination.|Analysis was done on the solicited safety set - All subjects in the exposed set with solicited AE data.||Number of subjects|||Number
657104|NCT01928186|Secondary|Baseline Standardized Uptake Values (SUV) by FLT PET|FLT SUV in breast tumor tissue as determined by the pre-therapy (baseline) FLT PET|Baseline|||g/mL||Full Range|Median
657105|NCT01928186|Secondary|Baseline FLT Transport (K1) Values by FLT PET|K1 (blood flow measure) in breast tumor tissue as determined by the pre-therapy (baseline) FLT PET|Baseline|||mL/min/mL||Full Range|Median
657077|NCT01928472|Primary|Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine|The number of subjects reporting unsolicited adverse events after receiving adjuvanted and unadjuvanted formulations of H7N9c vaccine was reported. Safety was assessed as the number of subjects who reported SAEs, at least possibly related SAEs, new onset of chronic diseases (NOCDs), medically attended AEs, AEs of Special Interest (AESIs), AEs leading to withdrawal from the study were collected from day 1 to day 366 following vaccination with adjuvanted and unadjuvanted formulations of H7N9 vaccine.|Day 1 to Day 366.|Analysis was done on unsolicited safety set.||Number of subjects|||Number
657078|NCT01928472|Primary|Number of Subjects Reporting Unsolicited Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine|Safety was assessed as the number of subjects who reported any AEs, and at least possibly related AEs are collected from day 1 to day 43 following vaccination with adjuvanted and unadjuvanted formulations of H7N9c vaccine.|Day 1 to Day 43|Analysis was done on unsolicited safety set - All subjects in the exposed set with unsolicited AE data.||Number of subjects|||Number
657079|NCT01928472|Secondary|Percentages Of Subjects With an HI Titers ≥1:40 at Six Months and at One Year After the First Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Persistence)|Percentages of subjects who achieved HI titers≥1:40 was measured at six months (day 183) and one year (day 366) after the first vaccination of a cell-culture derived H7N9 vaccine.|Day 183 and 366|FAS-Day 183 and FAS-Day 366||Percentages of subjects||95% Confidence Interval|Number
657080|NCT01928472|Secondary|Percentages Of Subjects Achieving Seroconversion at Six Months and One Year After Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Persistence)|"Percentage of subjects with HI seroconversion was measured as HI titer persistence at six months (day 183) and one year (day 366) after the first vaccination.
Seroconversion is defined as postvaccination HI titer>40 for subjects with baseline (day 1); HI titer <1:10 or a minimum four-fold increase in titer for subjects with baseline titer>1:10."|Day 183 and 366|FAS-Day 183 and FAS-Day 366||Percentages of subjects||95% Confidence Interval|Number
657081|NCT01928472|Secondary|Geometric Mean Ratios at Six Months and One Year After the First Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Persistence)|GMR of subjects was calculated as the ratio of postvaccination to prevaccination HI GMTs six months (day 183) and one year (day 366) after the first vaccination.|Day 183 and 366|FAS-Day 183 and FAS-Day 366||Ratio||95% Confidence Interval|Geometric Mean
657082|NCT01928472|Secondary|Geometric Mean Titers at Six Months and One Year After Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Persistence)|The immunogenicity was measured as GMTs in subjects as persistence at six months (day 183) and one year (day 366) after the first vaccination as measured by Hemagglutination Inhibition (HI) Assay.|Day 183 and 366.|FAS-Day 183 and FAS-Day 366||Titers||95% Confidence Interval|Geometric Mean
657083|NCT01928472|Secondary|Percentages Of Subjects With an HI Titers≥1:40 After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 22)|Percentage of subjects who achieved HI titers≥1:40 was measured at baseline (day 1) and three weeks after first (Day 22) vaccination.|Day 1 and 22.|FAS-Day 22||Percentages of subjects||95% Confidence Interval|Number
657084|NCT01928472|Secondary|Percentages Of Subjects Achieving Seroconversion After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 22)|"Percentage of subjects achieving HI seroconversion in HI titer was measured three weeks after first (day 22) vaccination.
Seroconversion is defined as postvaccination HI titer> 40 for subjects with baseline (day 1); HI titer <1:10 or a minimum 4-fold increase in titer for subjects with baseline titer >1:10."|Day 22|FAS-Day 22||Percentages of subjects||95% Confidence Interval|Number
657085|NCT01928472|Secondary|Geometric Mean Ratios In Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Day 22)|GMR of subjects was calculated as the ratio of postvaccination to prevaccination HI GMTs three weeks after first (day 22) vaccination.|Day 22|FAS-Day 22||Ratio||95% Confidence Interval|Geometric Mean
657086|NCT01928472|Secondary|Geometric Mean Titers Of Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Monovalent Vaccine, HI Assay (Day 22)|Immunogenicity was measured by HI assay and summarized through the GMTs at baseline (day 1) and three weeks after the first (day 22) vaccination.|Day 1 and 22|FAS-Day 22||Titers||95% Confidence Interval|Geometric Mean
657087|NCT01928472|Primary|Percentages Of Subjects With an HI Titers ≥1:40 After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 43)|Percentage of subjects who achieved HI titers≥1:40 was measured at baseline (day 1) and three weeks after second (Day 43) vaccination.|Day 1 and 43|FAS-Day 43.||Percentages of subejcts||95% Confidence Interval|Number
657088|NCT01928472|Primary|Percentages Of Subjects Achieving Seroconversion After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 43)|"Percentage of subjects achieving HI seroconversion in HI titer was measured three weeks after second (day 43) vaccination.
Seroconversion is defined as postvaccination HI titer> 40 for subjects with baseline (day 1); HI titer <1:10 or a minimum 4-fold increase in titer for subjects with baseline titer >1:10."|Day 43|FAS-Day 43||Percentages of subjects||95% Confidence Interval|Number
657089|NCT01928472|Primary|Geometric Mean Ratios In Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Day 43)|Geometric mean ratio (GMR) of subjects was calculated as the ratio of postvaccination to prevaccination HI GMTs three weeks after second (day 43) vaccination.|Day 43|FAS-Day 43||Ratio||95% Confidence Interval|Geometric Mean
657090|NCT01928472|Primary|Geometric Mean Titers Of Subjects After Each Vaccination Of a Cell-Culture Derived H7N9c Monovalent Vaccine, Hemagglutination Inhibition Assay (Day 43)|Immunogenicity was measured by Hemagglutination Inhibition (HI) assay and summarized through the geometric mean titers (GMTs) at baseline (day 1) and three weeks after the second (day 43) vaccination|Day 1 and 43|The analysis was done on Full Analysis Set – Subjects who received at least one study vaccination and provided immunogenicity at day 43 (FAS-Day 43).||Titers||95% Confidence Interval|Geometric Mean
657106|NCT01928186|Secondary|Baseline Ki (Flux Constant) Values by FLT PET|Ki (flux constant) in breast tumor tissue as determined by the pre-therapy (baseline) FLT PET scan|Baseline|||mL/min/mL||Full Range|Median
657107|NCT01928186|Secondary|Percentage Change in K1 (Blood Flow Parameter) by FLT PET|Percent change between pre-treatment (baseline) and post-therapy PET measurements in breast tumors will be computed.|Baseline to up to 6 weeks|||% change||Full Range|Median
657144|NCT01927120|Secondary|Cumulative Incidence of Chronic GVHD by Day +365|Cumulative incidence of chronic GVHD by day +365 per NIH Consensus criteria.|365 days post HCT|All participants.||percentage of participants||95% Confidence Interval|Number
657091|NCT01928433|Secondary|The Safety and Tolerability of Multiple Doses of Finafloxacin: Number of Participants Who Discontinued Due to TEAE|This study will evaluate the safety of the different regimens of finafloxacin. The safety outcome measures assessed are the following: vital signs, physical examinations, ECGs, haematology, biochemistry, urinalysis, adverse events and serious adverse events. Adverse events and serious adverse events will be documented throughout the study for each group (including comparator group and the incidence and severity of their occurrence will be compared between all groups. The results of all other safety outcome measures will be compared with the baseline values of each group to determine if significant changes occurred during the course of the study within one group. The results at the different visits will also be compared between the groups to identify significant differences between the 3 treatment groups.|Screening to day 24|Safety (SAF) population includes all subjects with at least one administration of study drug.||Participants|||Count of Participants
657092|NCT01928433|Secondary|The Safety and Tolerability of Multiple Doses of Finafloxacin: Number of Treatment-emergent Adverse Events|This study will evaluate the safety of the different regimens of finafloxacin. The safety outcome measures assessed are the following: vital signs, physical examinations, ECGs, haematology, biochemistry, urinalysis, adverse events and serious adverse events. Adverse events and serious adverse events will be documented throughout the study for each group (including comparator group and the incidence and severity of their occurrence will be compared between all groups. The results of all other safety outcome measures will be compared with the baseline values of each group to determine if significant changes occurred during the course of the study within one group. The results at the different visits will also be compared between the groups to identify significant differences between the 3 treatment groups.|Screening to Day 24|Safety (SAF) population includes all subjects with at least one administration of study drug.||Treatment-emergent AEs|||Number
657093|NCT01928433|Secondary|Number of Participants With Clinical and Microbiological Response at the End of Study (EoS) Visit (Day 24).|The clinical and microbiological response as the efficacy parameter will be assessed for each group and will be compared between the three groups. Separate analyses will be performed for all time points for the clinical and microbiological responders and compared also between the different groups.|Day 24|The micro-ITT population is composed of all randomized patients who have a baseline bacterial pathogen on culture of urine or blood that causes UTI against which the investigational drug has antibacterial activity.||Participants|||Count of Participants
657094|NCT01928433|Secondary|Number of Participants With Clinical and Microbiological Response at the End of Therapy (EoT) Visit (Day 10).|The clinical and microbiological response as the efficacy parameter will be assessed for each group and will be compared between the three groups. Separate analyses will be performed for all time points for the clinical and microbiological responders and compared also between the different groups.|Day 10|The micro-ITT population is composed of all randomized patients who have a baseline bacterial pathogen on culture of urine or blood that causes UTI against which the investigational drug has antibacterial activity.||Participants|||Count of Participants
657095|NCT01928433|Secondary|Number of Participants With Clinical and Microbiological Response at the On Therapy (OT) Visit (Day 3).|The clinical and microbiological response as the efficacy parameter will be assessed for each group and will be compared between the three groups. Separate analyses will be performed for all time points for the clinical and microbiological responders and compared also between the different groups.|Day 3|The micro-ITT population is composed of all randomized patients who have a baseline bacterial pathogen on culture of urine or blood that causes UTI against which the investigational drug has antibacterial activity.||Participants|||Count of Participants
657096|NCT01928433|Primary|Number of Participants With Clinical and Microbiological Response|"The primary endpoint of this study is the clinical and microbiological response of patients with cUTI or pyelonephritis to treatment with finafloxacin for 5 days versus finafloxacin for 10 days versus ciprofloxacin for 10 days as a reference comparator at the Test of Cure (ToC) visit (Day 17) in the microbiological intent-to-treat population (micro-ITT population).
Clinical response is defined as resolution of the symptoms of cUTI present at trial entry and no new symptoms developed. Microbiological response is defined as elimination or reduction of study entry pathogens to ≤ 10e3 CFU/mL on urine culture. The clinical and microbiological response will be assessed for each group on Day 17 and will be compared between the three groups to assess the efficacy in each group."|Day 17|The micro-ITT population is composed of all randomized patients who have a baseline bacterial pathogen on culture of urine or blood that causes UTI against which the investigational drug has antibacterial activity.||Participants|||Count of Participants
657097|NCT01928381|Post-Hoc|Brief Pain Index - Item 5, Average Daily Pain Score (Range 0-10) Higher Score Indicates Worse Pain - Per Protocol|Brief pain Index - diabetic painful neuropathy (BPI-DPN) - average daily pain, Item 5 (final 2 day home diary + in clinic assessment at end of 3 week treatment)|3 weeks of treatment|Per Protocol||Average daily pain score||Standard Error|Least Squares Mean
657098|NCT01928381|Primary|Brief Pain Index - Item 5, Average Daily Pain Score (Range 0-10) Higher Values Indicate Worse Pain|Brief pain Index - diabetic painful neuropathy (BPI-DPN) - average daily pain, Item 5 (final 2 day diary + in clinic assessment at end of 3 week treatment period)|3 weeks of treatment|Full Analysis set||Average daily pain score||Standard Error|Least Squares Mean
657099|NCT01928186|Secondary|Post-treatment Gene Expression Levels|Analyzed using BeadStudio software. Four clustering metrics for calculating dissimilarities (correlation, absolute correlation, Euclidean, and Manhattan) are available in BeadStudio and will be applied using standard analysis methods and diagnostics in BioConductor. To focus the analysis, proposed gene sets will be examined based on biological pathways and molecular signatures.|1 to 6 weeks post-therapy start||09/2017||||
657100|NCT01928186|Secondary|Pre-treatment Gene Expression Levels|Analyzed using BeadStudio software. Four clustering metrics for calculating dissimilarities (correlation, absolute correlation, Euclidean, and Manhattan) are available in BeadStudio and will be applied using standard analysis methods and diagnostics in BioConductor. To focus the analysis, proposed gene sets will be examined based on biological pathways and molecular signatures.|Baseline||09/2017||||
657101|NCT01928186|Secondary|Post-treatment Standardized Uptake Values (SUV) by FLT PET|FLT SUV in breast tumor tissue as determined by the post-treatment FLT PET|1 to 6 weeks post-therapy start|||g/mL||Full Range|Median
657102|NCT01928186|Secondary|Post-treatment FLT Transport (K1) Values by FLT PET|K1 (blood flow measure) in breast tumor tissue as determined by the post-therapy FLT PET|1 to 6 weeks post-therapy start|||mL/min/mL||Full Range|Median
657108|NCT01928186|Primary|Percentage Change in Ki-67 Positive Cells Between Pre-therapy and Post-therapy Tumor Specimens|"Tumor tissue samples from pre-treatment (baseline) biopsy and post-treatment surgery are stained using immuno-histochemistry techniques to visualize dividing cells expressing the Ki-67 protein, which is a cellular marker for proliferation.
The % values of positive cells from the baseline and post-treatment samples are then compared for each individual patient.
Association between Ki-67 and KFLT decline will be analyzed to evaluate the potential clinical utility of change in FLT as a biomarker for early response, using Ki-67 as the standard for early response."|Baseline to up to 6 weeks|||% change||Full Range|Median
657109|NCT01928186|Primary|Percentage of Ki-67 Positive Tumor Cells in Surgical (Post-therapy) Sample|Surgically removed breast tumor tissue is stained using immuno-histochemistry techniques to visualize dividing cells expressing the Ki-67 protein, which is a cellular marker for proliferation.|1 to 6 weeks post-therapy start|||% stained cells||Full Range|Median
657110|NCT01928186|Primary|Percent Change in SUV by FLT PET|Percent change between pre-treatment (baseline) and post-therapy measurements of FLT standardized uptake value (SUV) in breast tumors will be computed.|Baseline to up to 6 weeks|||% change||Full Range|Median
657111|NCT01928186|Primary|Percent Change in Net Influx Constant (Ki) by FLT PET|"Percent change between pre-treatment (baseline) and post-therapy PET measurements in breast tumors will be computed.
Association between Ki-67 and Ki by FLT (KFLT) decline will be analyzed using the mid-P adjustment to Fisher’s exact test to evaluate the potential clinical utility of change in FLT as a biomarker for early response, using Ki-67 as the standard for early response."|Baseline to up to 6 weeks|||% change||Full Range|Median
657112|NCT01928030|Secondary|Reduction in Forearm Volume|Number of patients that achieve a clinically significant reduction in lymphedema, assessed as a 20% reduction in excess forearm volume|Up to 1 year|No participants received 900 units rHuPH20, and the MTD was not determined, so no participants received rHuPH20 at the MTD.||Participants|||Count of Participants
657113|NCT01928030|Primary|Treatment-related Adverse Events|Reported as any untoward medical occurrence or worsening of a pre-existing medical condition in a participant administered recombinant human hyaluronidase, and judged possibly, probably, or definitely related to treatment|Up to 1 year|||Participants|||Count of Participants
657114|NCT01927887|Primary|Primary Efficacy Parameters of Specificity of High Resolution Magnetic Resonance Imaging With Lymphotrophic Superparamagnetic Nanoparticles (LSN MRI)|Using pathology as the gold standard the excised nodes will be correlated to histopathologic assessment and the primary efficacy parameters of LSN MRI will be determined for nodal staging. Specificity was determined by assessing the percentage of true negative nodes using pathology as a gold standard.|2 years|||percentage of true negative nodes||95% Confidence Interval|Number
657115|NCT01927887|Primary|Primary Efficacy Parameters of Sensitivity of High Resolution Magnetic Resonance Imaging With Lymphotrophic Superparamagnetic Nanoparticles (LSN MRI)|Using pathology as the gold standard the excised nodes will be correlated to histopathologic assessment and the primary efficacy parameters of LSN MRI will be determined for nodal staging|2 Years|||percentage of excised nodes||95% Confidence Interval|Number
657116|NCT01927757|Secondary|Work Productivity and Activity Impairment (WPAI)|This 6-item assessment measures productivity losses during the past 7 days and includes measures on work time missed due to health, impairment while working due to health (the participant’s assessment of the degree to which health affected their productivity while working), overall work impairment due to health (takes into account both hours missed due to health and the participant’s assessment of the degree to which health affected their productivity while working) and activity impairment due to health (the degree in which health problems affected their ability to do regular daily activities). Scores for each measure are expressed from 0 to 100 with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes.|Baseline, week 12 and week 24|"Full analysis set participants who were employed (for the first 3 scores); LOCF imputation was used. n indicates the number of participants included in each analysis."||units on a scale||Standard Deviation|Mean
657117|NCT01927757|Secondary|Change From Baseline in 36-item Short Form Health Survey (SF-36) at Week 24|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses of each domain, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning.|Baseline and Week 24|Full analysis set; LOCF imputation was used.||units on a scale||Standard Deviation|Mean
657118|NCT01927757|Secondary|Change From Baseline in 36-item Short Form Health Survey (SF-36) at Week 12|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses of each domain, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning.|Baseline and Week 12|Full analysis set; LOCF imputation was used.||units on a scale||Standard Deviation|Mean
657119|NCT01927757|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)|The HAQ-DI is a questionnaire on which participants are asked to rate their level of difficulty on daily activities (dressing and grooming, arising, eating, and walking) and personal abilities (hygiene, reach, grip, and activity) as well as their use of aids, devices, or help from another person for these activities and disabilities. Responses are scored from 0 indicating no difficulty to 3 indicating inability to perform a task in that area. The overall score is the average of each of the 8 category scores and ranges from 0 (no disability) to 3 (very severe, high-dependency disability).|Baseline and weeks 12 and 24|Full analysis set, last observation carried forward imputation (LOCF) was used.||units on a scale||Standard Deviation|Mean
657120|NCT01927757|Secondary|Percentage of Participants With DAS 28-CRP < 3.2|The DAS28-CRP is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables: • The number of swollen and tender joints assessed using the 28-joint count; • C-reactive protein (CRP) level • Patient's global assessment of disease activity assessed on a score from 0 to 100. The DAS28-CRP score ranges from zero up to approximately ten. DAS28-CRP scores less than 3.2 are considered low disease activity.|Weeks 12 and 24|Full analysis set, last observation carried forward imputation (LOCF) was used.||percentage of participants||95% Confidence Interval|Number
657121|NCT01927757|Secondary|Percentage of Participants With DAS28-CRP Improvement of ≥ 1.2 Units From Baseline|The DAS28-CRP is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables: • The number of swollen and tender joints assessed using the 28-joint count; • C-reactive protein (CRP) level • Patient's global assessment of disease activity assessed on a score from 0 to 100. The DAS28-CRP score ranges from zero up to approximately ten. DAS28-CRP scores above 5.1 indicate high disease activity.|Baseline and weeks 12 and 24|Full analysis set, last observation carried forward imputation (LOCF) was used.||percentage of participants||95% Confidence Interval|Number
657122|NCT01927757|Secondary|Change From Baseline in Disease Activity Score 28-C-Reactive Protein (DAS28-CRP)|"The DAS28-CRP is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables:
The number of swollen and tender joints assessed using the 28-joint count;
C-reactive protein (CRP) level
Patient's global assessment of disease activity assessed on a score from 0 to 100.
The DAS28-CRP score ranges from zero up to approximately ten. DAS28-CRP scores above 5.1 indicate high disease activity. A negative change from baseline indicates improvement."|Baseline and weeks 12 and 24|Full analysis set, last observation carried forward imputation (LOCF) was used.||units on a scale||Standard Deviation|Mean
657123|NCT01927757|Secondary|Percentage of Participants With an ACR 70 Response at Weeks 12 and 24|A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 70% improvement in tender joint count; • ≥ 70% improvement in swollen joint count; and • ≥ 70% improvement in at least 3 of the 5 following parameters: o Patient Global Assessment of Joint Pain (measured on a 100 mm VAS); o Patient Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Physician Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Health Assessment Questionnaire - Disability Index (HAQ-DI) scale from 0 to 3, where zero represents no disability and three very severe, high-dependency disability; o C-reactive protein level.|Baseline and Weeks 12 and 24|Full analysis set with non-missing data||percentage of participants||95% Confidence Interval|Number
657124|NCT01927757|Secondary|Percentage of Participants With an ACR 50 Response at Weeks 12 and 24|A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 50% improvement in tender joint count; • ≥ 50% improvement in swollen joint count; and • ≥ 50% improvement in at least 3 of the 5 following parameters: o Patient Global Assessment of Joint Pain (measured on a 100 mm VAS); o Patient Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Physician Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Health Assessment Questionnaire - Disability Index (HAQ-DI) scale from 0 to 3, where zero represents no disability and three very severe, high-dependency disability; o C-reactive protein level.|Baseline and Weeks 12 and 24|Full analysis set with non-missing data||percentage of participants||95% Confidence Interval|Number
657125|NCT01927757|Secondary|Percentage of Participants With an ACR 20 Response at Week 24|A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in tender joint count; • ≥ 20% improvement in swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: o Patient Global Assessment of Joint Pain (measured on a 100 mm VAS); o Patient Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Physician Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Health Assessment Questionnaire - Disability Index (HAQ-DI) scale from 0 to 3, where zero represents no disability and three very severe, high-dependency disability; o C-reactive protein level.|Baseline and Week 24|Full analysis set with non-missing data||percentage of participants||95% Confidence Interval|Number
657126|NCT01927757|Secondary|Percentage of Participants With an ACR 20 Response at Week 12 by Response Failure Type Subgroup|A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in tender joint count; • ≥ 20% improvement in swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: o Patient Global Assessment of Joint Pain (measured on a 100 mm VAS); o Patient Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Physician Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Health Assessment Questionnaire - Disability Index (HAQ-DI) scale from 0 to 3, where zero represents no disability and three very severe, high-dependency disability; o C-reactive protein level.|Baseline and Week 12|Full analysis set with non-missing data||percentage of participants||95% Confidence Interval|Number
657127|NCT01927757|Secondary|Percentage of Participants With an ACR 20 Response at Week 12 by Anti-adalimumab Antibody Subgroup|A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in tender joint count; • ≥ 20% improvement in swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: o Patient Global Assessment of Joint Pain (measured on a 100 mm VAS); o Patient Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Physician Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Health Assessment Questionnaire - Disability Index (HAQ-DI) scale from 0 to 3, where zero represents no disability and three very severe, high-dependency disability; o C-reactive protein level.|Baseline and Week 12|Full analysis set with non-missing data||percentage of participants||95% Confidence Interval|Number
657128|NCT01927757|Primary|Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Week 12|A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in tender joint count; • ≥ 20% improvement in swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: o Patient Global Assessment of Joint Pain (measured on a 100 mm VAS); o Patient Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Physician Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Health Assessment Questionnaire - Disability Index (HAQ-DI) scale from 0 to 3, where zero represents no disability and three very severe, high-dependency disability; o C-reactive protein level.|Baseline and Week 12|Full analysis set with non-missing data||percentage of participants||95% Confidence Interval|Number
657129|NCT01927575|Secondary|Radiation Reduction|To assess if a reduction in radiation dose can be achieved in the TOMO group as compared to imaging standards with equal or better injury detection rates from TOMO imaging.|Baseline Imaging Collection||||||
657145|NCT01927120|Secondary|Cumulative Incidence of Grade II-IV Acute GVHD by Day +100|Acute GVHD will be graded per the 1995 consensus guidelines.|100 days post HCT|All participants.||percentage of participants||95% Confidence Interval|Number
657130|NCT01927575|Primary|This Outcome Measure is Reporting the Number of Participants for Whom Hip, Wrist, or Tibia Injury Was Detected Using the TOMO as Well as Standard X-Ray and Standard CT|Clinical utility where the DTS could replace and/or complement existing imaging procedures; for example, Computed Tomography for fractures of the tibial plateau or scaphoid – where radiation dose, access to modality and cost play a factor in planning initial diagnosis and/or follow-up imaging strategies. Subsequent independent review by the principal investigator (PI) [or designee] to show the ability of the Fujifilm DTS system to provide images of clinical equivalence compared to those acquired on other FDA cleared imaging systems.|Baseline Imaging Collection|Three sets (1 - X-ray, 1- CT and 1 - Digital Tomosynthesis) of images of the tibia evaluated to confirm acceptable image quality and provided clinical and diagnostic value.||participants|||Number
657131|NCT01927419|Other Pre-specified|Number of Participants Who Died and With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Select AEs|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or unknown relationship to study drug.|Day 1 of treatment to within 30 days past last dose|All participants who received at least 1 dose of study drug||Participants|||Number
657132|NCT01927419|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Overall Quality of Life (QOL) Score|Health-related QOL was measured by mean changes from baseline in the EORTC-QLQ-C30 global health status/quality of life composite scale and by mean changes from baseline in the remaining EORTC QLQ-C30 questionnaire, Version 3. The EORTC QLQ-C30 is a questionnaire developed to assess the QOL of cancer patients. The questionnaire is a 30-item tool covering multiple items, including 5 functional scales (physical, role, emotional, social, and cognitive); 3 symptom scales (fatigue, nausea and vomiting, and pain); a global health status/QOL scale; and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Scores for each item range from 0 to 100. A high score for a functional scale represents a high (healthy) level of functioning, and a high score for the global health status represents a high QOL. However, a high score for a symptom scale represents more severe symptoms.|From Baseline to Week 25|All randomized participants. n=number of participants evaluable||Units on a scale||Standard Deviation|Mean
657133|NCT01927419|Secondary|Percentage of BRAF Mutation-positive Participants With Investigator-assessed Objective Response|Objective Response is is defined as the number of participants with a best overall response of complete response (CR) or partial response (PR); percentage is determined by that total divided by the number of randomized patients. CR=all target and nontarget lesions have disappeared. Lymph nodes selected must have returned to normal size (<10 mm). PR=at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|Randomization to a minimum of 6 months|All BRAF mutation-positive participants||Percentage of participants||95% Confidence Interval|Number
657134|NCT01927419|Secondary|Investigator-assessed Progression-free Survival (PFS) in All Populations|PFS is defined as the time between the date of randomization and the first date of documented progression, as assessed by the investigator, or death due to any cause, whichever occurs first. WT=wild type|Date of randomization to disease progression or death, whichever occurs first, to approximately 10 months|All randomized participants||Months||95% Confidence Interval|Median
657135|NCT01927419|Secondary|Percentage of Participants With Investigator-assessed Objective Response in the Randomized Population|Objective Response Rate is is defined as the number of participants with a best overall response of complete response (CR) or partial response (PR) divided by the number of randomized patients. CR=all target and nontarget lesions have disappeared. Lymph nodes selected must have returned to normal size (<10 mm). PR=at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|Randomization to a minimum of 6 months|All randomized participants||Percentage of participants||95% Confidence Interval|Number
657136|NCT01927419|Primary|Percentage of Participants With Investigator-assessed Objective Response in the Randomized, BRAF Wild-type Population|Objective Response Rate is defined as the number of participants with a best overall response of complete response (CR) or partial response (PR) divided by the number of randomized BRAF wild-type patients. CR=all target and nontarget lesions have disappeared. Lymph nodes selected must have returned to normal size (<10 mm). PR=at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|Randomization to a minimum of 6 months|All randomized BRAF wild-type participants .||Percentage of participants||95% Confidence Interval|Number
657137|NCT01927120|Other Pre-specified|Rate of Natural Killer Cell (NK) Reconstitution|Investigators planned to monitor natural killer cell (NK) reconstitution. Standard immune deficiency flow cytometry panels (IDP) was to be drawn on days +90, +180, and +365 to evaluate NK reconstitution. Results of standard lab tests to be compared to compiled data at a later date|365 days post HCT|Lab test results to be compared to compiled data at a later date.|||||
657138|NCT01927120|Other Pre-specified|Function of Blood Treg After Allogeneic HSCT|Percent of Treg suppression at day +30. Investigators had also planned to test Treg function at day +90, if sufficient Tregs had been available for analysis.|30 days post HCT|All evaluable participants at day +30.||percentage of suppression||Standard Deviation|Median
657139|NCT01927120|Secondary|STAT3, STAT5 (Y694), and S6 Phosphorylation Among Treg and Non-Treg at Day 90|Phosphorylation (p): pSTAT3, pSTAT5 (Y694), and pS6 among Treg and non-Treg at day +90.|90 days post HCT|All participants.||percentage in total CD4s||Full Range|Median
657140|NCT01927120|Secondary|STAT3, STAT5 (Y694), and S6 Phosphorylation Among Treg and Non-Treg at Day 30|Phosphorylation (p): pSTAT3, pSTAT5 (Y694), and pS6 among Treg and non-Treg at day +30.|30 days post HCT|All participants.||percentage in total CD4s||Full Range|Median
657141|NCT01927120|Secondary|Proportion of Treg Among Blood CD4+ T Cells at Day +90 After HCT|The proportion of Tregs to non-Treg CD4+ cells to be assessed at day +90. Natural Killer Cells (NKs): Median K/uL NK cells.|90 days post HCT|All participants.||K/uL NK cells||Full Range|Median
657142|NCT01927120|Secondary|Incidence of Unexpected or Serious Adverse Events (AEs)|Grade 3-5 unexpected or serious adverse events (AEs) according to Common Terminology Criteria for Adverse Events (CTCAE) v.4.03) were captured up to day +130 or 30 days after the last dose of IL-2. Events listed, with causality in relation to study treatment noted.|Up to days 130 post HCT|All participants.||adverse events|||Number
657148|NCT01927120|Primary|Regulatory T Cells (Tregs)/Total CD4+ Cells at Day 30 Post-HCT|Percentage of Treg among blood CD4+ T cells at day 30 after hematopoietic cell transplantation (HCT), to compare to SIR/TAC alone data from a previous trial (median of 16%). The study was designed to capture an increase in regulatory T cells from a median of 16.0% at day +30.|30 days post HCT|All participants.||percentage of CD4+Tregs||Full Range|Median
657149|NCT01927055|Primary|Change in Dizziness/ Lightheadedness/ Feeling Faint/ or Feeling Like You Might Blackout (OHSA Item 1)|OHSA item 1 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. A positive score indicates worsening during the double-blind randomized phase relative to value at randomization, while a negative score indicates an improvement in symptom severity.|Change from Randomization to Week 1|"Patients entering the double-blind, randomized phase and having a visit at week 1 of the double-blind phase were analyzed.
Study was stopped when only 5% of planned participants had completed the study to prevent competition with FDA mandated post-marketing requirement study."||units on a scale||Standard Deviation|Mean
657150|NCT01926977|Secondary|Patients With Post Injection Pain Score of One or Higher on Pain Scale|Pain score rated on an 11 point numerical rating from 0-10 ( 0 = no pain, and 10 = worst possible pain) administered to each patient verbally at visit #1 and visit #2. The data below shows number of patients with pain score 1 or greater in each group.|24 to 48 hours (visit #1) and 5 to 7 days (visit #2)|||participants|||Number
657151|NCT01926977|Primary|Evidence of Anterior Chamber Inflammation|Evidence of anterior chamber inflammation at visit #1 and #2 using Standardization of Uveitis Nomenclature (SUN)|24 to 48 hours (visit #1) and 5 to 7 days (visit #2)|||participants|||Number
657152|NCT01926782|Secondary|Percent Change From Baseline in Apo A1 in Participants Receiving Concomitant Statin Therapy at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. Apo A1 ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 12|Apo A1 ITT population (participants with concomitant statin therapy)||percent change||Standard Error|Least Squares Mean
657153|NCT01926782|Secondary|Percent Change From Baseline in Apo A1 in Participants Not Receiving Concomitant Statin Therapy at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. Apo A1 ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 12|Apo A1 ITT population (participants without concomitant statin therapy)||percent change||Standard Error|Least Squares Mean
657154|NCT01926782|Secondary|Percent Change From Baseline in Apo A1 in Participants Receiving Concomitant Statin Therapy at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. Subjects of the ITT population (subjects with or without concomitant statin therapy) with one baseline and at least one post-baseline Apo A1 value on- or off-treatment (Apo A1 ITT population). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 24|Apo A1 ITT population (participants with concomitant statin therapy)||percent change||Standard Error|Least Squares Mean
657155|NCT01926782|Secondary|Percent Change From Baseline in Apo A1 in Participants Not Receiving Concomitant Statin Therapy at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. Subjects of the ITT population (subjects with or without concomitant statin therapy) with one baseline and at least one post-baseline Apo A1 value on- or off-treatment (Apo A1 ITT population). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 24|Apo A1 ITT population (participants without concomitant statin therapy)||percent change||Standard Error|Least Squares Mean
657156|NCT01926782|Secondary|Percent Change From Baseline in Fasting Triglycerides in Participants Receiving Concomitant Statin Therapy at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment. ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 12|ITT population (participants with concomitant statin therapy)||percent change||Standard Error|Mean
657157|NCT01926782|Secondary|Percent Change From Baseline in Fasting Triglycerides in Participants Not Receiving Concomitant Statin Therapy at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment. ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 12|ITT population (participants without concomitant statin therapy)||percent change||Standard Error|Mean
657217|NCT01926015|Secondary|Geometric Mean Titers for Pertussis FHA Antibody|Participant serum was collected for determination of antibody responses before the first dose of study vaccine (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV|Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV|The per-protocol population included participants who received the 3 scheduled doses of DTP-IPV according to guidelines and did not have an important protocol deviation that may substantially affect the results of the endpoint||EU/mL||95% Confidence Interval|Geometric Mean
657158|NCT01926782|Secondary|Percent Change From Baseline in Fasting Triglycerides in Participants Receiving Concomitant Statin Therapy at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment. ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 24|ITT population (participants with concomitant statin therapy)||percent change||Standard Error|Mean
657159|NCT01926782|Secondary|Percent Change From Baseline in Fasting Triglycerides in Participants Not Receiving Concomitant Statin Therapy at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment. ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 24|ITT population (participants without concomitant statin therapy)||percent change||Standard Error|Mean
657160|NCT01926782|Secondary|Percent Change From Baseline in HDL-C in Participants Receiving Concomitant Statin Therapy at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. HDL-C ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 12|HDL-C ITT population (participants with concomitant statin therapy)||percent change||Standard Error|Least Squares Mean
657161|NCT01926782|Secondary|Percent Change From Baseline in HDL-C in Participants Not Receiving Concomitant Statin Therapy at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. HDL-C ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 12|HDL-C ITT population (participants without concomitant statin therapy)||percent change||Standard Error|Least Squares Mean
657162|NCT01926782|Secondary|Percent Change From Baseline in HDL-C in Participants Receiving Concomitant Statin Therapy at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. Subjects of the ITT population (with or without concomitant statin therapy) with one baseline and at least one post-baseline HDL-C value on- or off-treatment (HDL-C ITT population). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm|From Baseline to Week 24|HDL-C ITT population (participants with concomitant statin therapy)||percent change||Standard Error|Least Squares Mean
657163|NCT01926782|Secondary|Percent Change From Baseline in HDL-C in Participants Not Receiving Concomitant Statin Therapy at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. Subjects of the ITT population (with or without concomitant statin therapy) with one baseline and at least one post-baseline HDL-C value on- or off-treatment (HDL-C ITT population). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 24|HDL-C ITT population (participants without concomitant statin therapy)||percent change||Standard Error|Least Squares Mean
657164|NCT01926782|Secondary|Percent Change From Baseline in Lipoprotein (a) in Participants Receiving Concomitant Statin Therapy at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment. ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 12|ITT population (participants with concomitant statin therapy)||percent change||Standard Error|Mean
657165|NCT01926782|Secondary|Percent Change From Baseline in Lipoprotein (a) in Participants Not Receiving Concomitant Statin Therapy at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment. ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 12|ITT population (participants without concomitant statin therapy)||percent change||Standard Error|Mean
657166|NCT01926782|Secondary|Percent Change From Baseline in Lipoprotein (a) in Participants Receiving Concomitant Statin Therapy at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from a multiple imputation approach followed by robust regression model for handling of missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment were included in the imputation model. ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 24|ITT population (participants with concomitant statin therapy)||percent change||Standard Error|Mean
657712|NCT01916928|Secondary|The Accuracy of ccffDNA Compared to Genetic Information Obtained From Amniocentesis, Chorionic Villus Sampling, Fetal, or Placental Tissue.||3-4 weeks after specimen processing||||||
657167|NCT01926782|Secondary|Percent Change From Baseline in Lipoprotein (a) in Participants Not Receiving Concomitant Statin Therapy at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from a multiple imputation approach followed by robust regression model for handling of missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment were included in the imputation model. ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 24|ITT population (participants without concomitant statin therapy)||percent change||Standard Error|Mean
657168|NCT01926782|Secondary|Percentage of Participants (With Concomitant Statin Therapy) Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis|Adjusted percentages at Week 24 from multiple imputation approach model including available post-baseline data from Week 4 to Week 24 (i.e. up to 21 days after last injection). mITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|Up to Week 24|mITT population (participants with concomitant statin therapy)||percentage of participants|||Number
657169|NCT01926782|Secondary|Percentage of Participants (Without Concomitant Statin Therapy) Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis|Adjusted percentages at Week 24 from multiple imputation approach model including available post-baseline data from Week 4 to Week 24 (i.e. up to 21 days after last injection). mITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|Up to Week 24|mITT population (participants without concomitant statin therapy)||percentage of participants|||Number
657170|NCT01926782|Secondary|Percentage of Participants (With Concomitant Statin Therapy) Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis|Adjusted percentages at Week 24 were obtained from multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were included in the imputation model. ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|Up to Week 24|ITT population (participants with concomitant statin therapy)||percentage of participants|||Number
657171|NCT01926782|Secondary|Percentage of Participants (Without Concomitant Statin Therapy) Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis|Adjusted percentages at Week 24 were obtained from multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were included in the imputation model. ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|Up to Week 24|ITT population (participants without concomitant statin therapy)||percentage of participants|||Number
657172|NCT01926782|Secondary|Percentage of Very High CV Risk Participants Reaching Calculated LDL-C <70 mg/dL(1.81 mmol/L) or Moderate or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL(2.59 mmol/L) (With Concomitant Statin Therapy) at Week 24 - On-Treatment Analysis|Adjusted percentages at Week 24 were from multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection). mITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|Up to Week 24|mITT population (participants with concomitant statin therapy)||percentage of participants|||Number
657173|NCT01926782|Secondary|Percentage of Very High CV Risk Participants Reaching Calculated LDL-C<70 mg/dL (1.81 mmol/L) or Moderate or High CV Risk Participants Reaching Calculated LDL-C<100 mg/dL(2.59 mmol/L) (Without Concomitant Statin Therapy) at Week 24 - On-Treatment Analysis|Adjusted percentages at Week 24 were from multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection). mITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|Up to Week 24|mITT population (participants without concomitant statin therapy)||percentage of participants|||Number
657174|NCT01926782|Secondary|Percentage of Very High Cardiovascular (CV) Risk Participants Reaching Calculated LDL-C <70 mg/dL or Moderate or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (With Concomitant Statin Therapy) at Week 24 - ITT Analysis|Very high CV risk: history of documented coronary heart disease (CHD) or CHD risk equivalent. High CV risk: calculated 10-year fatal CVD risk score ≥5%, moderate chronic kidney disease, type 1/type 2 diabetes mellitus (DM) without target organ damage, or heFH not meeting definition of very high risk. Moderate CV risk: calculated 10-year fatal CVD risk score ≥1 &<5%. CHD risk equivalent: peripheral arterial disease, ischemic stroke, transient ischemic attack, abdominal aortic aneurysm, carotid artery(CA)occlusion>50%, carotid endarterectomy/CA stent procedure, renal artery stenosis/stent procedure, type 1/type 2 DM with target organ damage. Adjusted percentages at Week 24 obtained from multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment included in imputation model. ITT population (subjects with or without concomitant statin therapy).|Up to Week 24|ITT population (participants with concomitant statin therapy)||percentage of participants|||Number
657346|NCT01924299|Primary|PK: Tmax of Baricitinib Following Single Doses of Baricitinib Alone or Coadministered With Fluconazole||Days 1 and 7: predose of baricitinib and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours postdose|All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + fluconazole in Period 2) and had PK data to calculate Tmax of baricitinib.||hours||Full Range|Median
657175|NCT01926782|Secondary|Percentage of Very High CV Risk Participants Reaching Calculated LDL-C<70 mg/dL or Moderate or High CV Risk Participants Reaching Calculated LDL-C<100 mg/dL (Without Concomitant Statin Therapy) at Week 24 - ITT Analysis|Very high CV risk: history of documented coronary heart disease (CHD) or CHD risk equivalent. High CV risk: calculated 10-year fatal CVD risk score ≥5%, moderate chronic kidney disease, type 1/type 2 diabetes mellitus (DM) without target organ damage, or heFH not meeting definition of very high risk. Moderate CV risk: calculated 10-year fatal CVD risk score ≥1 &<5%. CHD risk equivalent: peripheral arterial disease, ischemic stroke, transient ischemic attack, abdominal aortic aneurysm, carotid artery(CA)occlusion>50%, carotid endarterectomy/CA stent procedure, renal artery stenosis/stent procedure, type 1/type 2 DM with target organ damage. Adjusted percentages at Week 24 obtained from multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment included in imputation model. ITT population (subjects with or without concomitant statin therapy).|Up to Week 24|ITT population (participants without concomitant statin therapy)||percentage of participants|||Number
657176|NCT01926782|Secondary|Percent Change From Baseline in Total-C at Week 12 in Participants Receiving Concomitant Statin Therapy - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. Total-C ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 12|Total-C ITT population (participants with concomitant statin therapy)||percent change||Standard Error|Least Squares Mean
657177|NCT01926782|Secondary|Percent Change From Baseline in Total-C at Week 12 in Participants Not Receiving Concomitant Statin Therapy - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. Total-C ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 12|Total-C ITT population (participants without concomitant statin therapy)||percent change||Standard Error|Least Squares Mean
657178|NCT01926782|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12 in Participants Receiving Concomitant Statin Therapy - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. Non-HDL-C ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 12|Non-HDL-C ITT population (participants with concomitant statin therapy).||percent change||Standard Error|Least Squares Mean
657179|NCT01926782|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12 in Participants Not Receiving Concomitant Statin Therapy - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. Non-HDL-C ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 12|Non-HDL-C ITT population (participants without concomitant statin therapy).||percent change||Standard Error|Least Squares Mean
657180|NCT01926782|Secondary|Percent Change From Baseline in Apo B at Week 12 in Participants Receiving Concomitant Statin Therapy - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. Apo B ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 12|Apo B ITT population (participants with concomitant statin therapy).||percent change||Standard Error|Least Squares Mean
657181|NCT01926782|Secondary|Percent Change From Baseline in Apo B at Week 12 in Participants Not Receiving Concomitant Statin Therapy - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. Apo B ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 12|Apo B ITT population (participants without concomitant statin therapy)||percent change||Standard Error|Least Squares Mean
657182|NCT01926782|Secondary|Percent Change From Baseline in Total-C at Week 24 in Participants Receiving Concomitant Statin Therapy - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. Subjects of the ITT population (with or without concomitant statin therapy) with one baseline and at least one post-baseline Total-C value on- or off-treatment (Total-C ITT population). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 24|Total-C ITT population (participants with concomitant statin therapy)||percent change||Standard Error|Least Squares Mean
657218|NCT01926015|Secondary|Geometric Mean Titers for Pertussis Toxin Antibody|Participant serum was collected for determination of antibody responses before the first dose of study vaccine (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV|Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV|The per-protocol population included participants who received the 3 scheduled doses of DTP-IPV according to guidelines and did not have an important protocol deviation that may substantially affect the results of the endpoint||EU/mL||95% Confidence Interval|Geometric Mean
657183|NCT01926782|Secondary|Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 in Participants Not Receiving Concomitant Statin Therapy - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. Subjects of the ITT population (with or without concomitant statin therapy) with one baseline and at least one post-baseline Total-C value on- or off-treatment (Total-C ITT population). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 24|Total-C ITT population (participants without concomitant statin therapy)||percent change||Standard Error|Least Squares Mean
657184|NCT01926782|Secondary|Percent Change From Baseline in Non-HDL-C at Week 24 in Participants Receiving Concomitant Statin Therapy - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection). Subjects of the mITT population (with or without concomitant statin therapy) with one baseline and at least one post-baseline non-HDL-C value on-treatment (non-HDL-C mITT population). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 24|Non-HDL-C mITT population (participants with concomitant statin therapy)||percent change||Standard Error|Least Squares Mean
657185|NCT01926782|Secondary|Percent Change From Baseline in Non-HDL-C at Week 24 in Participants Not Receiving Concomitant Statin Therapy - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection). Subjects of the mITT population (with or without concomitant statin therapy) with one baseline and at least one post-baseline non-HDL-C value on-treatment (non-HDL-C mITT population). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 24|Non-HDL-C mITT population (participants without concomitant statin therapy)||percent change||Standard Error|Least Squares Mean
657186|NCT01926782|Secondary|Percent Change From Baseline in Non-HDL-C at Week 24 in Participants Receiving Concomitant Statin Therapy - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. Subjects of the ITT population (with or without concomitant statin therapy) with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment (non-HDL-C ITT population). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 24|Non-HDL-C ITT population (participants with concomitant statin therapy)||percent change||Standard Error|Least Squares Mean
657187|NCT01926782|Secondary|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 in Participants Not Receiving Concomitant Statin Therapy - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. Subjects of the ITT population (with or without concomitant statin therapy) with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment (non-HDL-C ITT population). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 24|Non-HDL-C ITT population (participants without concomitant statin therapy)||percent change||Standard Error|Least Squares Mean
657188|NCT01926782|Secondary|Percent Change From Baseline in Apo B at Week 24 in Participants Receiving Concomitant Statin Therapy - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. Subjects of the ITT population (with or without concomitant statin therapy) with one baseline and at least one post-baseline Apo B value on- or off-treatment (Apo B ITT population). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 24|Apo B mITT population (participants with concomitant statin therapy)||percent change||Standard Error|Least Squares Mean
657189|NCT01926782|Secondary|Percent Change From Baseline in Apo B at Week 24 in Participants Not Receiving Concomitant Statin Therapy - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. Subjects of the ITT population (with or without concomitant statin therapy) with one baseline and at least one post-baseline Apo B value on- or off-treatment (Apo B ITT population). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 24|Apo B mITT population (participants without concomitant statin therapy)||percent change||Standard Error|Least Squares Mean
657190|NCT01926782|Secondary|Percent Change From Baseline in Apo B at Week 24 in Participants Receiving Concomitant Statin Therapy - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. Subjects of the ITT population (with or without concomitant statin therapy) with one baseline and at least one post-baseline Apo B value on- or off-treatment (Apo B ITT population). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 24|Apo B ITT population (participants with concomitant statin therapy)||percent change||Standard Error|Least Squares Mean
657304|NCT01925170|Primary|Cancer Detection Rate Per 1000 Women Screened, by Breast Density|The cancer detection rate per 1000 women screened is the estimate of the number of women with positive results from a screening test.|Within 21 days of mammography|||cancers per 1000 women screened||95% Confidence Interval|Number
657191|NCT01926782|Secondary|Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 in Participants Not Receiving Concomitant Statin Therapy - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. Subjects of the ITT population (with or without concomitant statin therapy) with one baseline and at least one post-baseline Apo B value on- or off-treatment (Apo B ITT population). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 24|Apo B ITT population (participants without concomitant statin therapy)||percent change||Standard Error|Least Squares Mean
657192|NCT01926782|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 in Participants Receiving Concomitant Statin Therapy - On-treatment Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 12|mITT population (participants with concomitant statin therapy)||percent change||Standard Error|Least Squares Mean
657193|NCT01926782|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 in Participants Not Receiving Concomitant Statin Therapy - On-treatment Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 12|mITT population (participants without concomitant statin therapy)||percent change||Standard Error|Least Squares Mean
657194|NCT01926782|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 in Participants Receiving Concomitant Statin Therapy - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 12|ITT population (participants with concomitant statin therapy)||percent change||Standard Error|Least Squares Mean
657195|NCT01926782|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 in Participants Not Receiving Concomitant Statin Therapy - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 12|ITT population (participants without concomitant statin therapy)||percent change||Standard Error|Least Squares Mean
657196|NCT01926782|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 24 in Participants Receiving Concomitant Statin Therapy - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection) (on-treatment analysis). Modified ITT (mITT) population (subjects with or without concomitant statin therapy): all randomized and treated subjects who did not receive concomitant statin therapy, with one baseline and at least one post-baseline calculated LDL-C value on-treatment. Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 24|mITT population||percent change||Standard Error|Least Squares Mean
657197|NCT01926782|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 24 in Participants Not Receiving Concomitant Statin Therapy - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection) (on-treatment analysis). Modified ITT (mITT) population (subjects with or without concomitant statin therapy): all randomized and treated subjects who did not receive concomitant statin therapy, with one baseline and at least one post-baseline calculated LDL-C value on-treatment. Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 24|Modified ITT (mITT) population (participants without concomitant statin therapy): all randomized and treated participants who did not receive concomitant statin therapy, with one baseline and at least one post-baseline calculated LDL-C value on-treatment.||percent change||Standard Error|Least Squares Mean
657198|NCT01926782|Primary|Percent Change From Baseline in Calculated LDL-C in Participants Receiving Concomitant Statin Therapy - Intent-to-Treat (ITT Analysis)|Adjusted least squares (LS) means and standard errors at Week 24 and at averaged Week 21 to 24 were obtained from a mixed effect model with repeated measures (MMRM) model to account for missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were used in this model (ITT analysis). ITT population (subjects with concomitant statin therapy): all randomized subjects who received concomitant statin therapy, with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment. Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 24|ITT population (participants with concomitant statin therapy): all randomized participants who received concomitant statin therapy, with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment.||percent change||Standard Error|Least Squares Mean
657367|NCT01923480|Secondary|Plasma Concentration of Phenylalanine||Three times during each 7 hour visit|One subject completed Period 1, but withdrew from the study prior to the start of Period 2.||micromol/L||Standard Deviation|Mean
657199|NCT01926782|Primary|Percent Change From Baseline in Calculated LDL-C in Participants Not Receiving Concomitant Statin Therapy - ITT Analysis|Adjusted LS means and standard errors at Week 24 and at averaged Week 21 to 24 from MMRM including available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. ITT population (subjects without concomitant statin therapy): all randomized subjects who did not receive concomitant statin therapy, with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment. Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 24|ITT population (participants without concomitant statin therapy): all randomized participants who did not receive concomitant statin therapy, with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment.||percent change||Standard Error|Least Squares Mean
657200|NCT01926626|Other Pre-specified|Tolerability of Moclobemide + Nicotine Patch|Tolerability of the moclobemide + nicotine patch treatment will be assessed by tabulating the number of participants requiring dose reductions (or discontinuation of medication).|1, 2, 4, 7 and 11 weeks after starting Moclobemide + Nicotine Patch|Participants who received Moclobemide.||participants|||Number
657201|NCT01926626|Secondary|Percentage of Change in Expired Air Carbon Monoxide (CO) During the First Week of Nicotine Patch Treatment.|The initial response to nicotine patch will be assessed by looking at the percent change in expired air carbon monoxide (CO) at the end of week one (Study Visit 2) relative to baseline (Study Visit 1).|Baseline and 1 week|Participants who received Moclobemide.||percentage of change||Standard Error|Mean
657202|NCT01926626|Other Pre-specified|Safety of Moclobemide + Nicotine Patch|"Safety of the moclobemide + nicotine patch treatment will be assessed by tabulating the number of participants rating side effects > moderate."|1, 2, 4, 7 and 11 weeks after starting Moclobemide + Nicotine Patch|Participants who received Moclobemide.||participants|||Number
657203|NCT01926626|Secondary|Percentage of Change in Smoking Withdrawal Symptoms|Withdrawal symptoms will be assessed by questionnaire on Quit Day, 1 week post quit, 3 weeks post quit, 6 weeks post quit,10 weeks post quit and 6 months post quit (if applicable) using the Shiffman-Jarvik questionnaire, which consists of 33-items rated from 1 to 7, where 1= not at all, 2= very little, 3= a little, 4= moderately, 5= a lot, 6= quite a lot, and 7= extremely. The 33 items are grouped into 8 subscales: Craving, Negative Affect, Appetite, Arousal, Somatic - Anxiety, Somatic - G.I., Somatic - Respiratory Tract, and Habit Withdrawal. The range of scores for each subscale will be 1-7, with higher scores indicating more of the withdrawal symptom having been experienced.|Quit day and 1 week, 3 weeks, 6 weeks, 10 weeks and 6 months post quit day|||percentage of change||Standard Error|Mean
657204|NCT01926626|Secondary|Continuous Ten Week Abstinence From Smoking|Number of participants who reported continuous ten-week abstinence from smoking (weeks 1-10 post quit day), confirmed by expired air CO.|10 weeks post quit day|||participants|||Number
657205|NCT01926626|Secondary|Point Abstinence From Smoking at Six Months Post Quit|Number of participants who reported 7-day point abstinence from smoking at six months post quit, confirmed by expired air CO.|7 day point abstinence from smoking at six months post quit|||participants|||Number
657206|NCT01926626|Primary|Continuous Four-week Abstinence From Smoking|Number of participants who reported continuous four-week abstinence from smoking (weeks 6-10 post target quit date), confirmed by expired air carbon monoxide (CO).|Weeks 6-10 post quit day|||participants|||Number
657207|NCT01926119|Secondary|Change in Motor Strength and Joint Range of Motion||End of each of the 5 treatment sessions and at 1-week follow-up relative to baseline|This data was not collected and therefore not analyzed.|||||
657208|NCT01926119|Secondary|Trophic Changes||End of each treatment session and at 1-week follow-up as compared to baseline|This data was not collected and therefore not analyzed.|||||
657209|NCT01926119|Secondary|Change in Sudomotor Function||End of each treatment session and at 1-week follow-up as compared to baseline|This data was not collected and therefore not analyzed.|||||
657210|NCT01926119|Secondary|Change in Vasomotor Function||End of each treatment session and at 1-week follow-up as compared to baseline|This data was not collected and therefore not analyzed.|||||
657211|NCT01926119|Secondary|Change in Sensory Perception||End of each treatment session and at 1-week follow-up as compared to baseline|This data was not collected and therefore not analyzed.|||||
657212|NCT01926119|Secondary|Change in Motor Function and Coordination|As assessed by functional capacity exam and physical exam|End of 5-day treatment series and at 1-week follow-up relative to baseline|This data was not collected and was therefore not analyzed.|||||
657213|NCT01926119|Primary|Change in Pain|Numerical rating scale (NRS) where 0=no pain and 10=worst pain imaginable|Baseline to post-TMS day 5|Completed 5 days of TMS||units on a scale||Full Range|Mean
657214|NCT01926015|Secondary|Geometric Mean Titers for Poliovirus Type 3 Antibody|Participant serum was collected for determination of antibody responses before the first dose of study vaccine (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV. Poliovirus antibodies are expressed as neutralizing antibody (NA) titers.|Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV|The per-protocol population included participants who received the 3 scheduled doses of DTP-IPV according to guidelines and did not have an important protocol deviation that may substantially affect the results of the endpoint||NA Titer||95% Confidence Interval|Geometric Mean
657215|NCT01926015|Secondary|Geometric Mean Titers for Poliovirus Type 2 Antibody|Participant serum was collected for determination of antibody responses before the first dose of study vaccine (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV. Poliovirus antibodies are expressed as neutralizing antibody (NA) titers.|Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV|The per-protocol population included participants who received the 3 scheduled doses of DTP-IPV according to guidelines and did not have an important protocol deviation that may substantially affect the results of the endpoint||NA Titer||95% Confidence Interval|Geometric Mean
657216|NCT01926015|Secondary|Geometric Mean Titers for Poliovirus Type 1 Antibody|Participant serum was collected for determination of antibody responses before the first dose of study vaccine (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV. Poliovirus antibodies are expressed as neutralizing antibody (NA) titers.|Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV|The per-protocol population included participants who received the 3 scheduled doses of DTP-IPV according to guidelines and did not have an important protocol deviation that may substantially affect the results of the endpoint||NA Titer||95% Confidence Interval|Geometric Mean
657219|NCT01926015|Secondary|Geometric Mean Titers for Tetanus Toxin Antibody|Participant serum was collected for determination of antibody responses before the first dose of study vaccine (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV|Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV|The per-protocol population included participants who received the 3 scheduled doses of DTP-IPV according to guidelines and did not have an important protocol deviation that may substantially affect the results of the endpoint||IU/mL||95% Confidence Interval|Geometric Mean
657220|NCT01926015|Secondary|Geometric Mean Titers for Diphtheria Toxin Antibody|Participant serum was collected for determination of antibody responses before the first dose of study vaccine (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV|Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV|The per-protocol population included participants who received the 3 scheduled doses of DTP-IPV according to guidelines and did not have an important protocol deviation that may substantially affect the results of the endpoint||IU/mL||95% Confidence Interval|Geometric Mean
657221|NCT01926015|Secondary|Percentage of Participants Reporting an Adverse Event of Special Interest: Injection-site Adverse Events|An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered study drug and which does not necessarily have to have a causal relationship with this treatment. Any worsening of a preexisting condition that is temporally associated with the use of the study drug is also an adverse event. Adverse events of special interest included fever, diarrhea, vomiting, and injection-site adverse events.|Period 1 (up to 14 days after Visit 1 [V1] or V2), Period 2 (up to 14 days after V3 or V4), Period 3 (up to 14 days after V5 or V6), and Overall (up to 14 days after any visit)|The safety population included randomized participants who received >=1 dose of study vaccine and had safety follow-up. Participants are counted only once within a study Period and only once Overall.||Percentage of participants|||Number
657222|NCT01926015|Secondary|Percentage of Participants Reporting an Adverse Event of Special Interest: Vomiting|An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered study drug and which does not necessarily have to have a causal relationship with this treatment. Any worsening of a preexisting condition that is temporally associated with the use of the study drug is also an adverse event. Adverse events of special interest included fever, diarrhea, vomiting, and injection-site adverse events.|Period 1 (up to 14 days after Visit 1 [V1] or V2), Period 2 (up to 14 days after V3 or V4), Period 3 (up to 14 days after V5 or V6), and Overall (up to 14 days after any visit)|The safety population included randomized participants who received >=1 dose of study vaccine and had safety follow-up. Participants are counted only once within a study Period and only once Overall.||Percentage of participants|||Number
657223|NCT01926015|Secondary|Percentage of Participants Reporting an Adverse Event of Special Interest: Diarrhea|An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered study drug and which does not necessarily have to have a causal relationship with this treatment. Any worsening of a preexisting condition that is temporally associated with the use of the study drug is also an adverse event. Adverse events of special interest included fever, diarrhea, vomiting, and injection-site adverse events.|Period 1 (up to 14 days after Visit 1 [V1] or V2), Period 2 (up to 14 days after V3 or V4), Period 3 (up to 14 days after V5 or V6), and Overall (up to 14 days after any visit)|The safety population included randomized participants who received >=1 dose of study vaccine and had safety follow-up. Participants are counted only once within a study Period and only once Overall.||Percentage of participants|||Number
657224|NCT01926015|Secondary|Percentage of Participants Reporting an Adverse Event of Special Interest: Fever|An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered study drug and which does not necessarily have to have a causal relationship with this treatment. Any worsening of a preexisting condition that is temporally associated with the use of the study drug is also an adverse event. Adverse events of special interest included fever, diarrhea, vomiting, and injection-site adverse events.|Period 1 (up to 14 days after Visit 1 [V1] or V2), Period 2 (up to 14 days after V3 or V4), Period 3 (up to 14 days after V5 or V6), and Overall (up to 14 days after any visit)|The safety population included randomized participants who received >=1 dose of study vaccine and had safety follow-up. Each participant was counted only once within a study Period and only once Overall.||Percentage of participants|||Number
657225|NCT01926015|Secondary|Percentage of Participants Reporting an Adverse Event With Incidence >=1%|An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered study drug and which does not necessarily have to have a causal relationship with this treatment. Any worsening of a preexisting condition that is temporally associated with the use of the study drug is also an adverse event. Adverse events with an incidence >=1% in either treatment group were recorded.|Up to 14 days after any of the 6 study visits|The safety population included randomized participants who received >=1 dose of study vaccine and had safety follow-up. Each participant was were counted only once overall.||Percentage of participants|||Number
657226|NCT01926015|Primary|Percentage of Participants Achieving Seroresponse for Diphtheria Toxin, Tetanus Toxin, Pertussis Filamentous Hemagglutinin (FHA), and Poliovirus Type 1, 2, and 3|Participant serum was collected for determination of antibody responses. Threshold levels for seroresponse were the following: Diphtheria Toxin, >=0.1 International Units (IU)/mL; Tetanus Toxin, >=0.01 IU/mL; Pertussis Toxin and Pertussis FHA, >=10 Enzyme Units (EU)/mL; Poliovirus Types 1, 2, and 3, neutralizing antibody (NA) titer >=8.|4 to 6 weeks after the third dose of DTP-IPV|The per-protocol population included participants who received the 3 scheduled doses of DTP-IPV according to guidelines and did not have an important protocol deviation that may substantially affect the results of the endpoint||Percentage of participants|||Number
657227|NCT01925781|Secondary|Point Prevalence Abstinence|No smoking in the previous 7 days. Self report will be biochemically confirmed with expired CO and salivary cotinine.|12 weeks|||participants|||Number
657228|NCT01925781|Primary|Sustained Abstinence|No smoking at 12 weeks after the predetermined quit date with a 5 day grace period. Self-report will be biochemically confirmed with expired carbon monoxide (CO) and salivary cotinine.|12 weeks|||participants|||Number
657305|NCT01925144|Primary|PK: Area Under the Plasma Concentration-Time Curve From Time 0 Hour to Infinity [AUC(0-∞)] of Baricitinib||Days 1 and 10: predose of baricitinib, 0.5, 0.75, 1, 2, 3, 4, 6, 12, 24, 36 and 48 hours postdose|All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + omeprazole in Period 2) and had PK data to calculate AUC(0-∞) of baricitinib.||nanograms*hour/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
657229|NCT01925768|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAE) During the 24 Week Placebo Controlled Phase|A TEAE is an AE with a start date on or after the date of the first dose of Investigational Product (IP). An AE is any noxious, unintended, or untoward medical occurrence, that may appear or worsen in a participant during the course of study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) was considered an AE. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly or birth defect, or a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above.|Start of the lst dose of IP to the end of the PBO controlled phase; Weeks 0-24 for those randomized to APR 30 mg; Weeks 0-24 for those randomized to PBO who did not enter EE at Week 16; Weeks 0-16 for those randomized to PBO who entered EE at Week 16|Safety population includes all participants who were randomized and received at least one dose of IP||Participants|||Number
657230|NCT01925768|Secondary|Change From Baseline in the Severity of Morning Stiffness at Weeks 52 and 104|Morning stiffness severity was the participant’s assessment of how severe their morning stiffness was after first waking up in the morning, on average, during the previous week. The severity was recorded as none, mild, moderate, moderately severe, or very severe. Improvement is defined as the change from baseline of a more severe assessment to less severe assessment.|Baseline and Weeks 52 and 104||11/2017||||
657231|NCT01925768|Secondary|Change From Baseline in the Duration of Morning Stiffness at Weeks 52 and 104|Morning stiffness was the participant’s assessment of how long their morning stiffness lasted after first waking up in the morning, on average, during the previous week. A negative change from the baseline duration indicates an improvement.|Baseline and Weeks 52 and 104||11/2017||||
657232|NCT01925768|Secondary|Change From Baseline in 36-item SF-36 (V2.0) Physical Functioning Component Scores and Summary Score at Weeks 52 and 104|The SF-36 (v 2.0) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.|Baseline and Weeks 52 and 104||11/2017||||
657233|NCT01925768|Secondary|Change From Baseline in the Disease Activity Score (DAS28) at Week 52 and 104|"The DAS28 measures the severity of disease at a specific time and is derived from the following variables:
28 tender joint count
28 swollen joint count, which do not include the DIP joints, the hip joint, or the joints below the knee;
C-reactive protein (CRP)
Patient's global assessment of disease activity. DAS28 (CRP) scores range from 0 to 9.4. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission. A negative change from baseline indicates improvement"|Baseline and Weeks 52 and 104||11/2017||||
657234|NCT01925768|Secondary|Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) at Weeks 52 and 104|HAQ-DI is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A higher score indicates worse physical functioning, and a negative change from baseline indicates improvement.|Baseline and Weeks 52 and 104||11/2017||||
657235|NCT01925768|Secondary|Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Weeks 52 and 104|Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in 78 tender joint count; • ≥ 20% improvement in 76 swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: o Patient's self-assessment of pain (measured on a 0 to 10 unit numeric rating scale [NRS]); o Patient's global self-assessment of disease activity (measured on a 0 to 10 unit NRS); o Physician's global assessment of disease activity (measured on a 0 to 10 unit NRS); o Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); o C-Reactive Protein (CRP)|Baseline and Weeks 52 and 104||11/2017||||
657236|NCT01925768|Secondary|Percentage of Participants Who Achieve an ACR 20 Response at Weeks 2, 4, 6, 8, 12 and 20|Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in 78 tender joint count; • ≥ 20% improvement in 76 swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: o Patient's self-assessment of pain (measured on a 0 to 10 unit numeric rating scale [NRS]); o Patient's global self-assessment of disease activity (measured on a 0 to 10 unit NRS); o Physician's global assessment of disease activity (measured on a 0 to 10 unit NRS); o Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); o C-Reactive Protein (CRP)|Baseline and at Weeks 2, 4, 6, 8, 12 and 20||11/2017||||
657237|NCT01925768|Secondary|Percentage of Participants Whose Severity of Morning Stiffness at Week 16 Improved From Baseline|Morning stiffness severity was the participant’s assessment of how severe their morning stiffness was after first waking up in the morning, on average, during the previous week. The severity was recorded as none, mild, moderate, moderately severe, or very severe. Improvement is defined as the change from baseline of a more severe assessment to less severe assessment.|Baseline and Week 16||11/2017||||
657238|NCT01925768|Secondary|Change From Baseline in the Duration of Morning Stiffness at Week 16|Morning stiffness was the participant’s assessment of how long their morning stiffness lasted after first waking up in the morning, on average, during the previous week. A negative change from the baseline duration indicates an improvement.|Baseline and Week 16||11/2017||||
657239|NCT01925768|Secondary|Change From Baseline in 36-item Short Form Health Survey (SF-36) V 2.0 Physical Functioning Domain at Week 16|The SF-36 (v 2.0) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.|Baseline and Week 16||11/2017||||
657240|NCT01925768|Secondary|Change From Baseline in the Disease Activity Score DAS28 (CRP) at Week 16|"The DAS28 measures the severity of disease at a specific time and is derived from the following variables:
28 tender joint count
28 swollen joint count, which do not include the DIP joints, the hip joint, or the joints below the knee;
C-reactive protein (CRP)
Patient's global assessment of disease activity. DAS28 (CRP) scores range from 0 to 9.4. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission. A negative change from baseline indicates improvement"|Baseline and Week 16||11/2017||||
657241|NCT01925768|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 16|HAQ-DI is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A higher score indicates worse physical functioning, and a negative change from baseline indicates improvement.|Baseline and Week 16||11/2017||||
657242|NCT01925768|Secondary|Percentage of Participants Whose Severity of Morning Stiffness at Week 24 Improved From Baseline|Morning stiffness severity was the participant’s assessment of how severe their morning stiffness was after first waking up in the morning, on average, during the previous week. The severity was recorded as none, mild, moderate, moderately severe, or very severe. Improvement is defined as the change from baseline of a more severe assessment to less severe assessment.|Baseline and Week 24||11/2017||||
657243|NCT01925768|Secondary|Change From Baseline in the Duration of Morning Stiffness at Week 24|Morning stiffness was the participant’s assessment of how long their morning stiffness lasted after first waking up in the morning, on average, during the previous week. A negative change from the baseline duration indicates an improvement.|Baseline and Week 24||11/2017||||
657244|NCT01925768|Secondary|Change From Baseline in the SF-36V2 Physical Component Summary Score at Week 24|The SF-36 (v 2.0) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.|Baseline and Week 24||11/2017||||
657245|NCT01925768|Secondary|Change From Baseline in the Medical Outcomes Short Form Health Survey (SF-36) V2 Physical Function Domain Score Change at Week 24|The SF-36 (v 2.0) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.|Baseline and Week 24||11/2017||||
657246|NCT01925768|Secondary|Change From Baseline in the 28-joint Disease Activity Score Using C-reactive Protein as the Acute-phase Reactant (DAS28 [CRP]) at Week 24|"The DAS28 measures the severity of disease at a specific time and is derived from the following variables:
28 tender joint count
28 swollen joint count, which do not include the DIP joints, the hip joint, or the joints below the knee;
C-reactive protein (CRP)
Patient's global assessment of disease activity. DAS28 (CRP) scores range from 0 to 9.4. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission. A negative change from baseline indicates improvement"|Baseline and Week 24||11/2017||||
657247|NCT01925768|Secondary|Percentage of Participants Who Achieve an ACR 20 Response at Week 24|Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in 78 tender joint count; • ≥ 20% improvement in 76 swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: o Patient's self-assessment of pain (measured on a 0 to 10 unit numeric rating scale [NRS]); o Patient's global self-assessment of disease activity (measured on a 0 to 10 unit NRS); o Physician's global assessment of disease activity (measured on a 0 to 10 unit NRS); o Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); o C-Reactive Protein (CRP)|Baseline and Week 24||11/2017||||
657248|NCT01925768|Secondary|Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 24|HAQ-DI is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A higher score indicates worse physical functioning, and a negative change from baseline indicates improvement.|Baseline and Week 24||11/2017||||
657306|NCT01925144|Primary|PK: Time of Maximum Observed Drug Concentration (Tmax) of Baricitinib||Days 1 and 10: predose of baricitinib, 0.5, 0.75, 1, 2, 3, 4, 6, 12, 24, 36 and 48 hours postdose|All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + omeprazole in Period 2) and had PK data to calculate Tmax of baricitinib.||hours||Full Range|Median
657249|NCT01925768|Primary|Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 16|Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in 78 tender joint count; • ≥ 20% improvement in 76 swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: o Patient's self-assessment of pain (measured on a 0 to 10 unit numeric rating scale [NRS]); o Patient's global self-assessment of disease activity (measured on a 0 to 10 unit NRS); o Physician's global assessment of disease activity (measured on a 0 to 10 unit NRS); o Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); o C-Reactive Protein (CRP)|Baseline and Week 16|FAS population consisting of all participants randomized as specified in the protocol; Those who withdrew early or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders. Non-responder imputation (NRI)||percentage of participants|||Number
657250|NCT01925703|Secondary|Serum Ferritin Level|Change in serum ferritin level compared to baseline and at follow-up within 1-4 weeks after last intravenous iron infusion|Baseline and at follow-up within 1-4 weeks|All participants who achieved complete iron repletion for whom follow up data were available.||nanograms per milliliter||95% Confidence Interval|Mean
657251|NCT01925703|Secondary|Transferrin Saturation|Change in transferrin saturation compared to baseline and at follow-up within 1-4 weeks after last intravenous iron infusion|Baseline and at follow-up within 1-4 weeks|All patients who achieved complete iron repletion for whom follow-up data were available.||Percentage of transferrin saturation||95% Confidence Interval|Mean
657252|NCT01925703|Primary|Serum Hemoglobin Concentration|Change in serum hemoglobin concentration compared to baseline and at follow-up within 1-4 weeks after last intravenous iron infusion|Baseline and at follow-up within 1-4 weeks|All patients who achieved complete iron repletion for whom follow up data were available.||grams per deciliter||95% Confidence Interval|Mean
657253|NCT01925469|Secondary|Change in Pain Score From Pre-procedure to 5 Minutes Post Procedure.|The patients pain scores will also be assessed at 5 minutes post procedure and the change in pain scores from baseline to this time points will be analyzed. The pain scores will be subtracted to obtain the change in pain score|5 minutes|||mm||95% Confidence Interval|Median
657254|NCT01925469|Secondary|Patient Satisfaction|The patient's satisfaction will be assessed using a validated satisfaction scale 30 minutes post procedure.|30 minutes post procedure|||participants|||Number
657255|NCT01925469|Primary|Change in Pain Score|The primary outcome is the difference in pain score using a validated visual analog scale before the procedure, which is designated as the pre-procedure (or baseline) pain score to the maximum pain during procedure (designated as time 0) These two pain scores will be subtracted and the change in pain score will be reported. The validated visual analog scale allows patients to report pain on a scale of 0 to 100 mm long. At the beginning and at the end, there are two descriptors representing extremes of pain (i.e. no pain = 0 and extreme pain = 100). The patient rated her pain by making a vertical mark on the 100-mm line. The measurement in millimeters was converted to the same number of points ranging from 0 to 100 points. There are no subgroups.|Pre-procedure (Baseline) and procedure (Time 0)|||mm||95% Confidence Interval|Median
657256|NCT01925417|Secondary|Post-treatment Hospitalization Data|number of ICU days was collected for subjects who received RBX2660 and who were subsequently hospitalized for recurrent CDAD treatment.|6 months|31 subjects had evaluable data at 6 months.||number of particpants' ICU days||Full Range|Median
657257|NCT01925417|Secondary|Quality of Life|Quality of life will be assessed by comparing the subject's baseline quality of life score to his/her scores obtained at the 7-, 30- and 60-day follow-up visits.|60 days||||||
657258|NCT01925417|Secondary|Absence of CDAD at 56 Days|Number of participants who were determined to be free of CDAD at Day 56 after receiving their last dose of RBX2660.|56 days|31 subjects had evaluable data at 56 days.||participants with treatment success|||Number
657259|NCT01925417|Secondary|Long-term Safety|The incidence of serious adverse events will be assessed through 6 months after the last treatment with RBX2660.|6 months|31 subjects had evaluable data at 6 months.||number of reported SAEs|||Number
657260|NCT01925417|Primary|Incidence of Serious Adverse Events Through 56 Days After the Last Treatment With RBX2660|Safety will be assessed by evaluating the incidence of serious adverse events through 56 days after the last treatment with RBX2660.|56 days|31 subjects had evaluable data at 56 days.||number of reported SAEs through 56 days|||Number
657261|NCT01925274|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Colorectal (FACT-C)|Functional Assessment of Cancer Therapy-Colorectal (FACT-C) was used in this study to assess Health-Related Quality of Life (HRQoL) and CRC-related symptoms in participants enrolled to the randomized portion of the study. The FACT-C is part of the Functional Assessment of Chronic Illness Therapy (FACIT) measurement system, a comprehensive and extensive set of self-reported instruments for the assessment of health-related quality of life in participants with cancer or other chronic illnesses.|2 years|Data for this outcome measure were no longer collected after approval of protocol amendment 4, and data previously collected were insufficient to perform any analysis.|||||
657262|NCT01925274|Secondary|Number of Participants With Expression of Pre-defined Gene Sequences in Biopsied Tumor Tissues|Pre-defined gene sequences were those related to EGFR, PI3K (phosphoinositide-3 kinase) and other oncogenic pathways; examples included but were not limited to PIK3CA (this gene encodes the catalytic subunit of PI3K), PIK3R1 (this gene encodes the regulatory subunit of PI3K), KRAS, NRAS and BRAF (this gene encodes serine/threonine-protein kinase B-Raf) sequences and PIK3CA gene amplification. Due to early termination of this study, these pre-defined gene sequences were not analyzed, except for KRAS and NRAS. Number of participants who had KRAS and NRAS wild type status confirmed by the central laboratory is presented.|2 years|All participants for whom at least one of these pre-defined gene sequences was analyzed were included.||participants|||Number
657263|NCT01925274|Secondary|Levels of Signaling Proteins in Paired and Single Tumor Biopsies|Pre defined signaling proteins included Akt (protein kinase B), p-Akt (phosphorylated Akt), p-S6 (phosphorylated ribosomal protein S6), p-Met (phosphorylated Met, a receptor tyrosine kinase), p-mTOR (phosphorylated mammalian target of rapamycin), EGFR (epithelial growth factor receptor), and p-EGFR (phosphorylated EGFR).|2 years|Data for this outcome measure were not collected due to early termination of this study.|||||
657368|NCT01923480|Secondary|Plasma Concentration of Ornithine||Three times during each 7 hour visit|One subject completed Period 1, but withdrew from the study prior to the start of Period 2.||micromol/L||Standard Deviation|Mean
657264|NCT01925274|Secondary|Area Under Plasma Concentration Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of SN-38|AUCinf refers to the area under plasma concentration time profile from time zero extrapolated to infinite time. AUCinf of SN-38 (an irinotecan metabolite) was calculated using the formula: AUCinf = AUClast + (Clast*/kel), where Clast* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis.|Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.|The pharmacokinetic parameter analysis set included all randomized participants (or enrolled participants to the Japanese LIC) who started treatment and had at least one of the pharmacokinetic parameters of interest estimated. As pre specified in protocol, this outcome measure was not analyzed for reporting arm: “Cetuximab + Irinotecan: Arm B”.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
657265|NCT01925274|Secondary|Area Under Plasma Concentration Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Irinotecan|AUCinf refers to the area under plasma concentration time profile from time zero extrapolated to infinite time. AUCinf of irinotecan was calculated using the formula: AUCinf = AUClast + (Clast*/kel), where Clast* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis.|Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.|The pharmacokinetic parameter analysis set included all randomized participants (or enrolled participants to the Japanese LIC) who started treatment and had at least one of the pharmacokinetic parameters of interest estimated. As pre-specified in protocol, this outcome measure was not analyzed for reporting arm: “Cetuximab + Irinotecan: Arm B”.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
657266|NCT01925274|Secondary|Area Under Plasma Concentration Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-05212384|AUCinf refers to the area under plasma concentration time profile from time zero extrapolated to infinite time. AUCinf of PF-05212384 was calculated using the formula: AUCinf = AUClast + (Clast*/kel), where Clast* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis.|Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 24, 72, 120 hours post PF-05212384 infusion on Cycle 1 Day 9.|The pharmacokinetic parameter analysis set included all randomized participants (or enrolled participants to the Japanese LIC) who started treatment and had at least one of the pharmacokinetic parameters of interest estimated. As pre-specified in protocol, this outcome measure was not analyzed for reporting arm: “Cetuximab + Irinotecan: Arm B”.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
657267|NCT01925274|Secondary|Area Under Plasma Concentration Time Profile From Time Zero to the Time for the Last Quantifiable Concentration (AUClast) of SN-38|AUClast refers to the area under plasma concentration time profile from time zero to the time for the last quantifiable concentration. AUClast of SN-38 (an irinotecan metabolite) was determined using linear/log trapezoidal method.|Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.|The pharmacokinetic parameter analysis set included all randomized participants (or enrolled participants to the Japanese LIC) who started treatment and had at least one of the pharmacokinetic parameters of interest estimated. As pre-specified in protocol, this outcome measure was not analyzed for reporting arm: “Cetuximab + Irinotecan: Arm B”.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
657268|NCT01925274|Secondary|Area Under Plasma Concentration Time Profile From Time Zero to the Time for the Last Quantifiable Concentration (AUClast) of Irinotecan|AUClast refers to the area under plasma concentration time profile from time zero to the time for the last quantifiable concentration. AUClast of irinotecan was determined using linear/log trapezoidal method.|Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.|The pharmacokinetic parameter analysis set included all randomized participants (or enrolled participants to the Japanese LIC) who started treatment and had at least one of the pharmacokinetic parameters of interest estimated. As pre-specified in protocol, this outcome measure was not analyzed for reporting arm: “Cetuximab + Irinotecan: Arm B”.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
657269|NCT01925274|Secondary|Area Under Plasma Concentration Time Profile From Time Zero to the Time for the Last Quantifiable Concentration (AUClast) of PF-05212384|AUClast refers to the area under plasma concentration time profile from time zero to the time for the last quantifiable concentration. AUClast of PF-05212384 was determined using linear/log trapezoidal method.|Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 24, 72, 120 hours post PF-05212384 infusion on Cycle 1 Day 9.|The pharmacokinetic parameter analysis set included all randomized participants (or enrolled participants to the Japanese LIC) who started treatment and had at least one of the pharmacokinetic parameters of interest estimated. As pre-specified in protocol, this outcome measure was not analyzed for reporting arm: “Cetuximab + Irinotecan: Arm B”.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
657270|NCT01925274|Secondary|Terminal Elimination Half Life (t½) of SN-38|T½ was calculated as loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.|Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.|The pharmacokinetic parameter analysis set included all randomized participants (or enrolled participants to the Japanese LIC) who started treatment and had at least one of the pharmacokinetic parameters of interest estimated. As pre-specified in protocol, this outcome measure was not analyzed for reporting arm: “Cetuximab + Irinotecan: Arm B”.||hours||Standard Deviation|Mean
657271|NCT01925274|Secondary|Terminal Elimination Half Life (t½) of Irinotecan|T½ was calculated as loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.|Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.|The pharmacokinetic parameter analysis set included all randomized participants (or enrolled participants to the Japanese LIC) who started treatment and had at least one of the pharmacokinetic parameters of interest estimated. As pre-specified in protocol, this outcome measure was not analyzed for reporting arm: “Cetuximab + Irinotecan: Arm B”.||hours||Standard Deviation|Mean
657307|NCT01925144|Primary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of Baricitinib||Days 1 and 10: predose of baricitinib, 0.5, 0.75, 1, 2, 3, 4, 6, 12, 24, 36 and 48 hours postdose|All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + omeprazole in Period 2) and had PK data to calculate Cmax of baricitinib.||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
657272|NCT01925274|Secondary|Terminal Elimination Half Life (t½) of PF-05212384|T½ was calculated as loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.|Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 24, 72, 120 hours post PF-05212384 infusion on Cycle 1 Day 9 and Cycle 1 Day 16.|The pharmacokinetic parameter analysis set included all randomized participants (or enrolled participants to the Japanese LIC) who started treatment and had at least one of the pharmacokinetic parameters of interest estimated. As pre-specified in protocol, this outcome measure was not analyzed for reporting arm: “Cetuximab + Irinotecan: Arm B”.||hours||Standard Deviation|Mean
657273|NCT01925274|Secondary|Time for Maximum Plasma Concentration (Tmax) of SN-38|SN-38 is an irinotecan metabolite. Tmax of SN-38 was observed directly from data as time of first occurrence.|Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.|The pharmacokinetic parameter analysis set included all randomized participants (or enrolled participants to the Japanese LIC) who started treatment and had at least one of the pharmacokinetic parameters of interest estimated. As pre specified in protocol, this outcome measure was not analyzed for reporting arm: “Cetuximab + Irinotecan: Arm B”.||hours||Full Range|Median
657274|NCT01925274|Secondary|Time for Maximum Plasma Concentration (Tmax) of Irinotecan|Tmax of irinotecan was observed directly from data as time of first occurrence.|Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.|The pharmacokinetic parameter analysis set included all randomized participants (or enrolled participants to the Japanese LIC) who started treatment and had at least one of the pharmacokinetic parameters of interest estimated. As pre-specified in protocol, this outcome measure was not analyzed for reporting arm: “Cetuximab + Irinotecan: Arm B”.||hours||Full Range|Median
657275|NCT01925274|Secondary|Time for Maximum Plasma Concentration (Tmax) of PF-05212384|Tmax of PF-05212384 was observed directly from data as time of first occurrence.|Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 24, 72, 120 hours post PF-05212384 infusion on Cycle 1 Day 9 and Cycle 1 Day 16.|The pharmacokinetic parameter analysis set included all randomized participants (or enrolled participants to the Japanese LIC) who started treatment and had at least one of the pharmacokinetic parameters of interest estimated. As pre-specified in protocol, this outcome measure was not analyzed for reporting arm: “Cetuximab + Irinotecan: Arm B”.||hours||Full Range|Median
657276|NCT01925274|Secondary|Maximum Plasma Concentration (Cmax) of SN-38|SN-38 is an irinotecan metabolite. Cmax of SN-38 was observed directly from data.|Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.|The pharmacokinetic concentration analysis set included all randomized participants (or enrolled participants to the Japanese LIC) who started treatment and had at least one time point with a concentration measurement recorded. As pre-specified in protocol, this outcome measure was not analyzed for reporting arm: “Cetuximab + Irinotecan: Arm B”.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
657277|NCT01925274|Secondary|Maximum Plasma Concentration (Cmax) of Irinotecan|Cmax of irinotecan was observed directly from data.|Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.|The pharmacokinetic concentration analysis set included all randomized participants (or enrolled participants to the Japanese LIC) who started treatment and had at least one time point with a concentration measurement recorded. As pre-specified in protocol, this outcome measure was not analyzed for reporting arm: “Cetuximab + Irinotecan: Arm B”.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
657278|NCT01925274|Secondary|Maximum Plasma Concentration (Cmax) of PF-05212384|Cmax of PF-05212384 was observed directly from data.|Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 24, 72, 120 hours post PF-05212384 infusion on Cycle 1 Day 9 and Cycle 1 Day 16.|The pharmacokinetic concentration analysis set included all randomized participants (or enrolled participants to the Japanese LIC) who started treatment and had at least one time point with a concentration measurement recorded. As pre-specified in protocol, this outcome measure was not analyzed for reporting arm: “Cetuximab + Irinotecan: Arm B”.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
657279|NCT01925274|Secondary|Number of Participants With ECG Maximum Increase From Baseline Meeting Pre-defined Criteria|"The number of participants with ECG maximum increase from baseline meeting the following criteria was reported:
Criterion A: maximum QTc interval increase from baseline >30 msec and ≤60 msec; criterion B: maximum QTc interval increase from baseline >60 msec; criterion C: maximum QTcB interval increase from baseline >30 msec and ≤60 msec; criterion D: maximum QTcB interval increase from baseline >60 msec; criterion E: maximum QTcF interval increase from baseline >30 msec and ≤60 msec; criterion F: maximum QTcF interval increase from baseline >60 msec."|2 years|QTc analysis set included all participants in the safety analysis set who had at least one ECG assessment after receiving study treatment.||participants|||Number
657280|NCT01925274|Secondary|Number of Participants With ECG Post-Baseline Maximum Absolute Values Meeting Pre-defined Criteria|The number of participants with ECG post-baseline maximum absolute values meeting the following criteria was reported: (1) maximum QTc interval ranged from 450 to 480 msec; >480-500 msec; >500 msec; (2) maximum QTcB (QT corrected for heart rate using Bazett’s formula) interval ranged from 450 to 480 msec; >480-500 msec; >500 msec; (3) maximum QTcF (QT corrected for heart rate using Fridericia’s formula) interval ranged from 450 to 480 msec; >480-500 msec; >500 msec.|2 years|QTc analysis set included all participants in the safety analysis set who had at least one ECG assessment after receiving study treatment.||participants|||Number
657281|NCT01925274|Secondary|Number of Participants With Laboratory Test (Coagulation) Abnormalities|Coagulation analysis included partial thromboplastin time (PTT) and international normalized ratio (INR) or prothrombin time (PT).|2 years|Safety analysis set included all participants who received at least one dose of study treatment, with treatment arm assignment designated according to actual study treatment received.||participants|||Number
657282|NCT01925274|Secondary|Number of Participants With Laboratory Test (Urinalysis) Abnormalities|Urinalysis included urine dipstick for protein and blood: if positive, perform a microscopic analysis. Number of participants with urine protein tested positive is presented.|2 years|Safety analysis set included all participants who received at least one dose of study treatment, with treatment arm assignment designated according to actual study treatment received.||participants|||Number
657308|NCT01924975|Secondary|Before Attempts of the Cannulation Are Made, Investigators Will Measure the Diameter of the Saphenous Vein With Ultrasound Imaging to Determine if There is Correlation Between Size of the Vein and Success Rate.||10 minutes||||||
657283|NCT01925274|Secondary|Number of Participants With Laboratory Test (Chemistry) Abnormalities|The following chemistry parameters were evaluated in this study: sodium, potassium, magnesium, chloride, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, total bilirubin, albumin, blood urea nitrogen (BUN) or urea, creatinine, total calcium, glycosylated hemoglobin (HbA1c), glucose, uric acid, phosphorus or phosphate, insulin, and C-peptide.|2 years|Safety analysis set included all participants who received at least one dose of study treatment, with treatment arm assignment designated according to actual study treatment received.||participants|||Number
657284|NCT01925274|Secondary|Number of Participants With Laboratory Test (Hematology) Abnormalities|The following hematology parameters were evaluated in this study: hemoglobin, white blood cells (WBC) with differential, and platelets.|2 years|Safety analysis set included all participants who received at least one dose of study treatment, with treatment arm assignment designated according to actual study treatment received.||participants|||Number
657285|NCT01925274|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Common Terminology Criteria for Adverse Events (CTCAE) Grade|TEAEs were those AEs with initial onset or increasing in severity after the first dose of study drug. CTCAE version 4.0 was used to grade the severity of TEAEs. Grade 1 referred to mild AEs; Grade 2 referred to moderate AEs; Grade 3 referred to severe AEs; Grade 4 referred to AEs with life-threatening consequences, and urgent intervention was needed to manage them; Grade 5 referred to death related to AE.|Administration of the first dose of study drug through 28 calendar days after the last administration of study drug|Safety analysis set included all participants who received at least one dose of study treatment, with treatment arm assignment designated according to actual study treatment received.||participants|||Number
657286|NCT01925274|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. An SAE was defined as any untoward occurrence at any dose that resulted in death; was life threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect. AEs included both serious and non-serious AEs. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study drug.|Administration of the first dose of study drug through 28 calendar days after the last administration of study drug|Safety analysis set included all participants who received at least one dose of study treatment, with treatment arm assignment designated according to actual study treatment received.||participants|||Number
657287|NCT01925274|Secondary|Overall Survival (OS)|Overall survival (OS) was defined as the duration from enrollment to death. Participants last known to be alive were censored at date of last contact.|2 years|Per protocol analysis set, i.e. all participants who were randomized, with KRAS and NRAS wild type status confirmed by central lab and with treatment arm assignment designated according to randomization. As pre-specified in protocol, this outcome measure was not analyzed for reporting arm “PF 05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)”.||months||95% Confidence Interval|Median
657288|NCT01925274|Secondary|Duration of Response|For participants with an objective response (CR or PR), duration of response was defined as the time from first documentation of CR or PR to date of first documentation of objective progression or death. Date of first documentation of progression and date of first documentation of CR or PR were based on Investigator's assessment of response.|2 years|The analysis population included all participants who achieved CR or PR in Arm A and Arm B. As pre-specified in protocol, this outcome measure was not analyzed for reporting arm “PF 05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)”.||months||95% Confidence Interval|Median
657289|NCT01925274|Secondary|Percentage of Participants With Objective Response|Percentage of participants with objective response was based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria In Solid Tumors (RECIST), version 1.1. Confirmed PR was defined as disappearance of all target lesions. Confirmed PR was defined as >=30% decrease in sum of the longest dimensions of the target lesions taking the baseline sum as a reference. Confirmed responses were those that persisted on repeat imaging study >=4 weeks after initial documentation of response.|2 years|Response evaluable analysis set was used for the analysis of objective response, and it included all participants in the full analysis set (all participants who were randomized, with treatment arm assignment designated according to randomization) who had an adequate baseline assessment of disease and measurable disease.||percentage of participants||95% Confidence Interval|Number
657290|NCT01925274|Secondary|Number of Participants With Unacceptable Toxicity in Cycle 1 (Japanese LIC Only)|Unacceptable toxicity (according to Common Terminology Criteria for Adverse Events [CTCAE], Version 4.0) was any of the following occurrences: (1) Grade 4 neutropenia >7 days, or febrile neutropenia, or Grade 4 thrombocytopenia; (2) Grade >=3 nausea/vomiting despite optimal antiemetic treatment, or Grade >=3 diarrhea despite optimal anti diarrheal treatment; (3) unmanageable Grade >=3 hyperglycemia; (4) mean QTc interval (time from electrocardiogram [ECG] Q wave to the end of the T wave corresponding to electrical systole, corrected for heart rate) >501 msec in triplicate 12-lead ECG, or myocardial infarction, or ventricular arrhythmia; (5) Grade >=3 non-hematologic toxicity; (6) treatment delay of >=2 weeks due to study drug related toxicity; (7) persistent, intolerable toxicities which resulted in failure to deliver at least 75% of doses of both PF-05212384 and irinotecan during Cycle 1; (8) Grade >=2 respiratory toxicities.|28 days|The analysis population included all participants enrolled into Japanese LIC. As pre-specified in protocol, this outcome measure was not analyzed for reporting arms: “PF-05212384 + Irinotecan: Arm A” and “Cetuximab + Irinotecan: Arm B”.||participants|||Number
657309|NCT01924975|Secondary|Investigators Will Measure the Required Time for the Successful Venous Cannulation Between Groups.||10 minutes||||||
657310|NCT01924975|Secondary|A Comparison Will be Made Between Groups for Overall Success Rate Within 3 Attempt of Needle Insertions or a 10 Minute Time Period, Whichever Comes First.||10 minutes||||||
657311|NCT01924975|Primary|The Primary Object is to Compare the First Attempt Success Rate Between Ultrasound Group and Landmark Group for Saphenous Vein Cannulation.||10 minutes|||percentage of participants|||Number
657369|NCT01923480|Secondary|Plasma Concentration of Methionine||Three times during each 7 hour visit|One subject completed Period 1, but withdrew from the study prior to the start of Period 2.||micromol/L||Standard Deviation|Mean
657291|NCT01925274|Primary|Progression Free Survival (PFS) as Assessed by Investigators|Progression-free survival (PFS) was the time from the first dose of study treatment to the first documentation of objective tumor progression or death due to any cause, whichever occurred first. Objective progression was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum was observed during therapy), with a minimum absolute increase of 5 mm. Median PFS was estimated based on the Kaplan-Meier method.|From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years|All participants who were randomized, with KRAS (Kirsten ras oncogene) and NRAS (neuroblastoma ras viral oncogene homolog) wild type status confirmed by central lab, and with treatment arm assignment designated according to randomization. As pre-specified in the protocol, this outcome measure was not analyzed for Japanese Lead-In Cohort.||months||95% Confidence Interval|Median
657292|NCT01925209|Secondary|Change From Baseline in Short Physical Performance Battery (SPPB) Score at Week 52|The SPPB evaluated lower extremities function by testing gait speed, ability to keep standing balance and time to rise from a chair five times. The sub-score for each test ranged from 0 to 4. The summary score, which was a summation of scores from the 3 tests, ranged from 0 to 12. An increase in score indicates improvement in physical performance. A negative change from baseline indicates deterioration.|Baseline, Week 52|The Full Analysis Set (FAS), which included all randomized participants who had received at least one dose of study drug and had at least one post-baseline efficacy assessment, was analyzed.||score on a scale||Standard Error|Least Squares Mean
657293|NCT01925209|Secondary|Estimated Annual Number of Falls Per Patient Within Treatment Group|Participants documented any fall occurrences in a paper diary during the study.|Week 52|The Full Analysis Set (FAS), which included all randomized participants who had received at least one dose of study drug and had at least one post-baseline efficacy assessment, was analyzed.||Annual number of falls per participant|||Number
657294|NCT01925209|Secondary|Change From Baseline in Sporadic Inclusion Body Myositis (sIBM) Functional Assessment (sIFA) Score at Week 52|Self-reported physical function was assessed by a newly developed patient reported outcome named sporadic inclusion body myositis (sIBM) functional assessment (sIFA). The sIFA consists of 11 items scored on an 11 point numerical rating scale from 0 (no difficulty) to 10 (unable to do) across 3 domains: upper body functioning, lower body functioning and general functioning. Participants completed the assessment where the recall period was the past week prior to completing the patient reported outcome (PRO). The total score on the sIFA scale ranges from 0 (minimum) to 110 (maximum). Higher values represent a worse outcome. A positive change from baseline indicates deterioration.|Baseline, Week 52|The Full Analysis Set (FAS), which included all randomized participants who had received at least one dose of study drug and had at least one post-baseline efficacy assessment, was considered for the analysis. Only those participants from the FAS who had both baseline and week 52 sIFA measurements were analyzed.||score on a scale||Standard Error|Least Squares Mean
657295|NCT01925209|Secondary|Change From Baseline in Quadriceps Quantitative Muscle Testing (QMT) on the Right Side at Week 52|Quadriceps muscle strength was measured by portable fixed dynamometry (PFD) on the right side. A negative change from baseline indicates deterioration.|Baseline, Week 52|The Full Analysis Set (FAS), which included all randomized participants who had received at least one dose of study drug and had at least one post-baseline efficacy assessment, was considered for the analysis. Only those participants from the FAS who had both baseline and week 52 QMT measurements were analyzed.||newtons||Standard Error|Least Squares Mean
657296|NCT01925209|Secondary|Estimated Within Treatment Group Lean Body Mass (LBM) Ratio at Week 52|LBM was measured via dual energy x-ray absorptiometry (DXA) and calculated as (LBM at Week 52/LBM at baseline)*100 . A positive change from baseline indicates improvement.|Baseline, Week 52|The Full Analysis Set (FAS), which included all randomized participants who had received at least one dose of study drug and had at least one post-baseline efficacy assessment, was considered for the analysis. Only those participants from the FAS who had both baseline and week 52 LBM measurements were analyzed.||Percentage||95% Confidence Interval|Number
657297|NCT01925209|Primary|Change From Baseline in 6 Minute Walking Distance (6MWD) Test at Week 52|The 6MWD test measured the distance (in meters) that a participant walked in a 6 minute timeframe. A positive change from baseline indicates improvement.|Baseline, Week 52|The Full Analysis Set (FAS), which included all randomized participants who had received at least one dose of study drug and had at least one post-baseline efficacy assessment, was considered for the analysis. Only those participants from the FAS who had both baseline and week 52 6MWD measurements were analyzed.||meters||Standard Error|Least Squares Mean
657298|NCT01925183|Primary|Proportions of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)||Baseline (BL) to Follow-up week 12 (FU12)|||Participants|||Count of Participants
657299|NCT01925183|Primary|Proportion of Subjects With Sustained Virologic Response (SVR12)|Defined as HCV-RNA negativity by a sensitive assay|Follow-up week 12 (FU12)|||Participants|||Count of Participants
657300|NCT01925170|Secondary|Biopsy Rate|Biopsy rate = number of participants who had a biopsy/number of number of participants analyzed.|12 months after mammography and MBI|||percentage of participants||95% Confidence Interval|Number
657301|NCT01925170|Secondary|Recall Rate|Recall rate was defined as the percentage of participants recalled for follow-up studies initiated because of abnormal findings with mammography or MBI.|12 months after mammography and MBI|The analysis population only included participants with a verified cancer status at 12 months after the initial screening (mammography and MBI).||percentage of participants||95% Confidence Interval|Number
657302|NCT01925170|Secondary|Sensitivity for All Cancers Diagnosed|Sensitivity measures the percentage of actual positives which are correctly identified as such.|Within 21 days of mammography|The analysis population only included participants with a verified cancer status at 12 months after the initial screening. 21 participants out of the total study population of 1585 were diagnosed with cancer.||percentage of actual positives||95% Confidence Interval|Number
657303|NCT01925170|Secondary|Specificity|Specificity measures the percentage of negatives which are correctly identified as such.|Within 21 days of mammography|The analysis population only included participants with a verified negative cancer status at 12 months after the initial screening (mammography and MBI).||percentage of true negatives||95% Confidence Interval|Number
657370|NCT01923480|Secondary|Plasma Concentration of Lysine||Three times during each 7 hour visit|One subject completed Period 1, but withdrew from the study prior to the start of Period 2.||micromol/L||Standard Deviation|Mean
657312|NCT01924949|Secondary|Percentage of Participants Experiencing Virologic Failure|"Virologic failure was defined as
On-treatment virologic failure:
Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)
Virologic relapse:
Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Baseline to posttreatment Week 24|Full Analysis Set||percentage of participants|||Number
657313|NCT01924949|Secondary|HCV RNA Change From Baseline||Baseline; Weeks 1, 4, and 8|Full Analysis Set||log10 IU/mL||Standard Deviation|Mean
657314|NCT01924949|Secondary|Percentage of Participants With HCV RNA < LLOQ on Treatment||Up to 12 weeks|Full Analysis Set||percentage of participants|||Number
657315|NCT01924949|Secondary|Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set||percentage of participants|||Number
657316|NCT01924949|Primary|Percentage of Participants Permanently Discontinuing Study Drug Due to an Adverse Event||Up to 12 weeks|Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug||percentage of participants|||Number
657317|NCT01924949|Primary|Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants who were enrolled and received at least 1 dose of study drug||percentage of participants|||Number
657318|NCT01924871|Other Pre-specified|Postoperative Pain|The outcomes assessor will evaluate the degree of postoperative pain using a numeric rating scale (NRS). (0 = no pain, 10 = unimaginable severe pain)|Participants will be followed for the duration of postanesthesia care unit (PACU) stay, an expected average of 1 hour.||||||
657319|NCT01924871|Secondary|Success Rate & Complication Rate Including Cough|We will assess the success rate of deep extubation without complication and the occurrence of cough during emergence from general anesthesia.|assessing the success rate of deep extubation without complication and the occurrance of cough from the completion of surgery to 5minute after extubation.||||||
657320|NCT01924871|Primary|Awakening Time|The outcomes assessor will record from the time of extubation in operating room to the time of eye opening and mouth opening|Participants will be followed from the time of extubation in operating room to the time of discharge from recovery room, an expected average of 1day.|||minutes||Inter-Quartile Range|Median
657321|NCT01924767|Secondary|Serum Insulin|"Serum insulin measured for on day -2 and day 8 for Emax0-5, Emax0-12, Emin0-5 and Emin0-12.
Emax: Maximum effect (maximum measured concentration of glucose or insulin in plasma) & Emin: Minimum effect (minimum measured concentration of glucose or insulin in plasma)"|0.0h, 2h, 5h, 7h, 10h, 12h on day -2 & day 8|PDS||µU/mL||Standard Deviation|Mean
657322|NCT01924767|Secondary|Serum Insulin|"Serum insulin measured for on day -2 and day 8 for AUEC0-5 and AUEC0-12. AUEC0-5: The area under the effect concentration-time curve over the time interval 0 to 5.
AUEC0-12: The area under the effect concentration-time curve over the time interval 0 to 12."|0.0h, 2h, 5h, 7h, 10h, 12h on day -2 & day 8|PDS||µU*h/mL||Standard Deviation|Mean
657323|NCT01924767|Secondary|Fasting Plasma Glucose|Percentage change from baseline to Day 8 in fasting plasma glucose. Baseline is defined as Day -2.|-0:30 (Pre dose samples)|PDS||percentage of fasting plasma glucose||Standard Deviation|Mean
657324|NCT01924767|Secondary|Mean Daily Glucose|Change from baseline to Day 8 in mean daily glucose. Baseline is defined as Day -2.|0:00, 2:00, 5:00, 7:00, 10:00, 12:00,13:30 and 24:00 hours(h) after drug administration on day -2 and -0.05, 2:30, 5:00, 7:00, 10:00, 12.00, 13:30 and 24:00 hours (h) after drug administration on day 8|PDS||mg/dL||Standard Deviation|Mean
657325|NCT01924767|Secondary|Change From Baseline to Day 8 in Urinary Glucose Excretion|Change from baseline to day 8 in urinary glucose excretion. Baseline is defined as Day -2.|-2-0 hours(h) before drug administration and 0-2, 2-4, 4-6, 6-8, 8-12,12-16 and 16-24 h after drug administration on day -2 and day 8|Pharmacodynamic (PD) analysis set (PDS) contains of all patients who received study medication and have evaluable pharmacodynamic parameter data.||mg||Standard Deviation|Mean
657326|NCT01924767|Secondary|Accumulation Ratios|"Accumulation ratio based on Cmax (RA,Cmax) and Accumulated ratio based on AUC0-tau (RA,AUC) at steady-state.
Accumulation ratio for the respective doses were calculated using below mentioned equations:
RA,Cmax = Cmax,ss/Cmax
RA,AUC= AUCtau,ss/AUCtau"|-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1. -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.|PK set||Ratio||Geometric Coefficient of Variation|Geometric Mean
657327|NCT01924767|Secondary|Linearity Index|The linearity index is defined as AUC0-tau divided by AUC0-∞ both at steady state.|-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1. -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.|PK set||Fraction||Geometric Coefficient of Variation|Geometric Mean
657328|NCT01924767|Secondary|Peak Trough Fluctuation|Peak trough fluctuation (PTF) is defined as the difference between Cmax and Cmin divided by Cavg and multiplied with 100% at steady-state|-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1. -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.|PK set||PTF(%) of Empagliflozin||Geometric Coefficient of Variation|Geometric Mean
657329|NCT01924767|Secondary|Apparent and Renal Clearance of the Analyte in Plasma|"Apparent clearance of the analyte in plasma (CL/F) after first dose and at steady-state, Renal clearance of the analyte in plasma after extravascular administration (CLR) after first dose and at steady-state.
Apparent clearance after first dose is defined as the dose divided by AUC0-∞; apparent clearance at steady-state is defined as the dose divided by AUC0-tau at steady-state.
Renal clearance CLR(0-t) is defined as Ae0-t divided by AUC0-t."|-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1. -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.|PK set||mL/min||Geometric Coefficient of Variation|Geometric Mean
657330|NCT01924767|Secondary|Fraction of Analyte Excreted Unchanged in Urine|"Fraction of analyte excreted unchanged in urine in the time interval 0 to 12 h (fe0-12) after first dose and at steady-state. The fraction excreted was calculated by dividing Ae0-12 by the Dose and multiply it with 100.
Fraction of analyte excreted unchanged in urine in the time interval 0 to 24 h (fe0-24) after first dose and at steady-state. The fraction excreted was calculated by dividing Ae0-24 by the Dose and multiply it with 100."|0-2, 2-4, 4-6, 6-8, 8-12, 12-16, 16-24, 24-36, 36-48 hours (h) after dose on day 1 and 0-2, 2-4, 4-6, 6-8, 8-12, 12-16, 16-24, 24-36, 36-48 and 48-72 hours (h) after dose on day 9|PK set||percent of analyte||Geometric Coefficient of Variation|Geometric Mean
657331|NCT01924767|Secondary|Amount of Analyte Eliminated in Urine|Amount of analyte that is eliminated in urine after first dose and at steady state from the time interval 0 to 24 h (Ae0-24) and 0 to 48 h (Ae0-48)|0-2, 2-4, 4-6, 6-8, 8-12, 12-16, 16-24, 24-36, 36-48 hours (h) after dose on day 1 and 0-2, 2-4, 4-6, 6-8, 8-12, 12-16, 16-24, 24-36, 36-48 and 48-72 hours (h) after dose on day 9|PK set||nmol||Geometric Coefficient of Variation|Geometric Mean
657332|NCT01924767|Secondary|Apparent Volume of Distribution During the Terminal Phase|Apparent volume of distribution during the terminal phase (Vz/F) after first dose and at steady state. Apparent volume is defined as CL/F divided by the terminal rate constant in plasma (either after first dose or at steady-state).|-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1. -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.|PK set||L||Geometric Coefficient of Variation|Geometric Mean
657333|NCT01924767|Secondary|Half-life and Mean Residence Time of the Analyte in Plasma|Terminal half life of the analyte in plasma (t1/2) and mean residence time of the analyte in the body after single oral administration (MRTpo) after first dose and at steady-state.|-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1. -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.|PK Set||h||Geometric Coefficient of Variation|Geometric Mean
657334|NCT01924767|Secondary|Terminal Rate Constant in Plasma|Terminal rate constant in plasma after first dose and at steady-state|-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1. -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.|PK set||1/h||Geometric Coefficient of Variation|Geometric Mean
657335|NCT01924767|Secondary|Time to Maximum Concentration of the Analyte in Plasma|Time from last dosing to maximum concentration of the analyte in plasma (tmax) after first dose and at steady-state|-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1.-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.|PK set||h||Full Range|Median
657336|NCT01924767|Secondary|Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval (AUC)|AUC0-∞: from 0 extrapolated to infinity after first dose AUCtau,1: over a uniform dosing interval tau after first dose AUCtau,ss: over a uniform dosing interval tau at steady-state AUCs were computed using the linear up/log down algorithm. If an analyte concentration was equal to or higher than the preceding concentration, the linear trapezoidal method was to be used. If the analyte concentration was smaller than the preceding concentration, the logarithmic method was to be used.|-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1.-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.|PK set||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
657337|NCT01924767|Secondary|Concentration of the Analyte in Plasma|Maximum concentration of the analyte in plasma (Cmax) after first dose, Maximum, minimum (Cmin) and average (Cavg) concentration of the analyte in plasma at steady-state, Concentration of analyte in plasma at 24 h after administration of the 8th dose (at steady-state) (C24,8)|-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1.-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.|Pharmacokinetic set (PK set) contains of all patients who received study medication and have evaluable pharmacokinetic parameter data. The PK set will not contain placebo patients.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
657338|NCT01924767|Primary|Assessment of Tolerability by Investigator|Tolerability will be assessed by the investigator according to the categories good, satisfactory, not satisfactory and bad.|day 21|Treated set||percentage of participants|||Number
657339|NCT01924767|Primary|Micturition Frequency|Micturition frequency is reported as change from pre-treatment to day 9 during the day, the night and total. Baseline is the mean of days 8-3 before drug administration.|Baseline and Day 9|Treated set||frequency of micturition||Standard Deviation|Mean
657340|NCT01924767|Primary|Percentage of Participants With Clinically Relevant Findings in Electrocardiogram (ECG) Results|Percentage of participants with clinically relevant findings in electrocardiogram (ECG) results|day 1 to day 21|Treated set||percentage of participants|||Number
657341|NCT01924767|Primary|Percentage of Participants With Clinically Relevant Findings in Physical Examination, Vital Signs and Clinical Laboratory Tests|Percentage of participants with clinically relevant findings in physical examination, vital signs and clinical laboratory tests. Relevant findings or worsenings of baseline conditions were reported as Adverse Events (cardiac disorders and investigations).|day 1 to day 21|Treated set.||percentage of participants|||Number
657342|NCT01924559|Primary|Time to Successful Intubation|Time from initiation of intubation attempt to successful 2 breaths demonstrating lung expansion, estimated less than 1 minute|approximately one minute|EM Residents who tested/participated in each of the six groups||seconds||Full Range|Mean
657343|NCT01924390|Other Pre-specified|Change in Ridge Width and Ridge Height|Ridge width and height are measured at time of tooth extraction & grafting, and again 18-20 weeks later at time of implant placement. Changes in ridge height and width are determined.|At time of implant placement, which is 18-20 weeks after grafting of extraction socket|||change in ridge width (loss of width mm)||Standard Deviation|Mean
657344|NCT01924390|Secondary|Percent Residual Graft Material and Percent Connective Tissue|Bone core biopsy will be evaluated histologically for percent residual bone graft material and percent connective tissue|18-20 weeks|||percentage of residual graft||Standard Deviation|Mean
657345|NCT01924390|Primary|Percent New Vital Bone Formation|Bone core biopsy will be evaluated histologically for percent new vital bone formation|18-20 weeks|||percentage of vital bone||Standard Deviation|Mean
657347|NCT01924299|Primary|PK: Time of Maximum Observed Drug Concentration (Tmax) of Baricitinib Following Single Doses of Baricitinib Alone or Coadministered With Ketoconazole||Days 1 and 6: predose of baricitinib and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours postdose|All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + ketoconazole in Period 2) and had PK data to calculate Tmax of baricitinib.||hours||Full Range|Median
657348|NCT01924299|Primary|PK: Cmax of Baricitinib Following Single Doses of Baricitinib Alone or Coadministered With Fluconazole||Days 1 and 7: predose of baricitinib and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours postdose|All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + fluconazole in Period 2) and had PK data to calculate Cmax of baricitinib.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
657349|NCT01924299|Primary|PK: Maximum Concentration (Cmax) of Baricitinib Following Single Doses of Baricitinib Alone or Coadministered With Ketoconazole||Days 1 and 6: predose of baricitinib and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours postdose|All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + ketoconazole in Period 2) and had PK data to calculate Cmax of baricitinib.||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
657350|NCT01924299|Primary|PK: AUC(0-∞) of Baricitinib Following Single Doses of Baricitinib Alone or Coadministered With Fluconazole||Days 1 and 7: predose of baricitinib and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours postdose|All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + fluconazole in Period 2) and had PK data to calculate AUC(0-∞) of baricitinib.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
657351|NCT01924299|Primary|Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve From Time 0 Hour to Infinity [AUC(0-∞)] of Baricitinib Following Single Doses of Baricitinib Alone or Coadministered With Ketoconazole||Days 1 and 6: predose of baricitinib and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours postdose|All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + ketoconazole in Period 2) and had PK data to calculate AUC(0-∞) of baricitinib.||nanograms*hour/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
657352|NCT01924182|Other Pre-specified|Sleep Assessment|"Compare changes from Baseline to Month 3 between the IT group and CMM group for:
Sleep and respiratory parameters collected via overnight polysomnography (PSG, sleep study)"|3 Month||||||
657353|NCT01924182|Secondary|Opioid-Related Side Effects|Summarize the changes from Baseline to Month 3 between the IT group and CMM group in CTCAE|3 Month||||||
657354|NCT01924182|Secondary|Pain Assessment|Compare changes from Baseline to Month 3 between the IT group and CMM group in NPRS|3 Month||||||
657355|NCT01924182|Primary|Clinical Success|Determine the proportion of subjects with clinical success based on changes in pain intensity (Numerical Pain Rating Scale: NPRS) and opioid-related Common Toxicity Criteria for Adverse Events (CTCAE) from the National Cancer Institute (NCI).|3 Month|2 of the 3 randomized participants did not complete the follow-up or provide outcome information. As there was only 1 participant that completed the primary outcome assessment, no statistical analysis will be presented.||participants|||Number
657356|NCT01923896|Primary|Disruptions|Disruptions were defined as turning the head 45 degrees away from the spoon and/or pushing away the spoon or feeder’s hand/arm during the bite presentation. Converted counts of each variable into percentages by dividing the total occurrence of a target behavior during a meal by the total number of bites presented per meal|Mealtime behavior (disruptions) at meal 13|||percentage of inappropriate behaviors||Inter-Quartile Range|Median
657357|NCT01923896|Primary|Disruptions|Disruptions were defined as turning the head 45 degrees away from the spoon and/or pushing away the spoon or feeder’s hand/arm during the bite presentation. Converted counts of each variable into percentages by dividing the total occurrence of a target behavior during a meal by the total number of bites presented per meal|Mealtime behavior (disruptions) at meal 1|||percentage of inappropriate behaviors||Inter-Quartile Range|Median
657358|NCT01923896|Primary|Rapid Swallowing|Rapid swallowing was scored if the child swallowed the entire bolus within 30 seconds after the feeder deposited the bite. This was visually confirmed by the feeder using a three-step prompting sequence (i.e., verbal: ‘‘show me’’; gestural: ‘‘show me like this’’ plus modeling opening the mouth; physical: ‘‘show me’’ plus gentle pressure applied to the side of the teeth with a baby spoon).|Mealtime behavior (swallowing) at meal 13|All subjects completed up to meal 13.||percentage of bites||Inter-Quartile Range|Median
657359|NCT01923896|Primary|Rapid Swallowing|Rapid swallowing was scored if the child swallowed the entire bolus within 30 seconds after the feeder deposited the bite. This was visually confirmed by the feeder using a three-step prompting sequence (i.e., verbal: ‘‘show me’’; gestural: ‘‘show me like this’’ plus modeling opening the mouth; physical: ‘‘show me’’ plus gentle pressure applied to the side of the teeth with a baby spoon).|Mealtime behavior (swallowing) at meal 1|||percentage of bites||Inter-Quartile Range|Median
657360|NCT01923805|Primary|Transfusion Requirements|The primary objective of this study is to test for significant differences in transfusion requirements in patients managed with RTKA.|Participants will be followed for the duration of hospital stay, an expected average of 12 weeks.|Data were not collected from participants enrolled in the study|||||
657361|NCT01923480|Secondary|Plasma Concentration of Valine||Three times during each 7 hour visit|One subject completed Period 1, but withdrew from the study prior to the start of Period 2.||micromol/L||Standard Deviation|Mean
657362|NCT01923480|Secondary|Plasma Concentration of Tyrosine||Three times during each 7 hour visit|One subject completed Period 1, but withdrew from the study prior to the start of Period 2.||micromol/L||Standard Deviation|Mean
657363|NCT01923480|Secondary|Plasma Concentration of Threonine||Three times during each 7 hour visit|One subject completed Period 1, but withdrew from the study prior to the start of Period 2.||micromol/L||Standard Deviation|Mean
657364|NCT01923480|Secondary|Plasma Concentration of Taurine||Three times during each 7 hour visit|No data available as no data for this outcome measure were collected during the study.|||||
657365|NCT01923480|Secondary|Plasma Concentration of Serine||Three times during each 7 hour visit|One subject completed Period 1, but withdrew from the study prior to the start of Period 2.||micromol/L||Standard Deviation|Mean
657366|NCT01923480|Secondary|Plasma Concentration of Proline||Three times during each 7 hour visit|One subject completed Period 1, but withdrew from the study prior to the start of Period 2.||micromol/L||Standard Deviation|Mean
657380|NCT01923480|Secondary|Plasma Stable Isotope Enrichment of Tyrosine||Twelve times during each 7 hour visit|One subject completed Period 1, but withdrew from the study prior to the start of Period 2. During both periods (1 and 2), samples were not obtained from any subjects at the 0hr time point.||trace/tracee ratio||Standard Deviation|Mean
657381|NCT01923480|Secondary|Plasma Stable Isotope Enrichment of Phenylalanine||Twelve times during each 7 hour visit|One subject completed Period 1, but withdrew from the study prior to the start of Period 2. During both periods (1 and 2), samples were not obtained from any subjects at the 0hr time point.||trace/tracee ratio||Standard Deviation|Mean
657382|NCT01923480|Secondary|Serum Concentration of Insulin||Five times during each 7 hour visit|One subject completed Period 1, but withdrew from the study prior to the start of Period 2. One subject in grp 0.04 g/kg/hr, seq BA, serum concentration of insulin was not collected at any time point during Period 1. One subject in grp 0.08 g/kg/hr, seq AB, serum concentration of insulin was not collected at the 3hr time point during Period 2.||mciu/mL||Standard Deviation|Mean
657383|NCT01923480|Secondary|Plasma Concentration of Glucose||Nine times during each 7 hour visit|One subject completed Period 1, but withdrew from the study prior to the start of Period 2. One subject in grp 0.04 g/kg/hr, seq BA, plasma concentration of glucose was not collected at any time point during Period 1.||mg/dL||Standard Deviation|Mean
657384|NCT01923480|Secondary|Insulin Sensitivity||Five times during each 7 hour visit|No data available as no data for this outcome measure were collected during the study.|||||
657385|NCT01923480|Primary|Change in Net Protein Synthesis||One time at pre-clinisol infusion and one time at post-clinisol infusion|One subject completed Period 1, but withdrew from the study prior to the start of Period 2.||g protein/d/kg ffm||Standard Deviation|Mean
657386|NCT01923467|Primary|Acceptance of Offer to Join Stop Smoking Program|After participation in online image viewing and writing reflection tasks, participants will be asked if they would like to take part in an online stop-smoking program.|1 Day of Enrollment|||participants|||Number
657387|NCT01923389|Secondary|Observed Accumulation Ratio (Rac) for Cmax and AUCtau of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)||Day 25|Rac for C-terminus and N-terminus of PF-05231023 and CVX-2000 were not summarzied due to the premature termination of the study.|||||
657388|NCT01923389|Secondary|Terminal Elimination Half-life (t1/2)of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)||Day 25|t1/2 for C-terminus and N-terminus of PF-05231023 and CVX-2000 were not summarzied due to the premature termination of the study.|||||
657389|NCT01923389|Secondary|Clearance (CL)of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)||Day 25|CL for C-terminus and N-terminus of PF-05231023 and CVX-2000 were not summarzied due to the premature termination of the study.|||||
657390|NCT01923389|Secondary|Time for Cmax (Tmax)of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)||Day 25|Tmax for C-terminus and N-terminus of PF-05231023 and CVX-2000 were not summarzied due to the premature termination of the study.|||||
657391|NCT01923389|Secondary|Average Concentration at Steady State (Cav) of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)||Day 25|Cav for C-terminus and N-terminus of PF-05231023 and CVX-2000 were not reported due to the premature termination of the study.|||||
657392|NCT01923389|Secondary|Lowest Concentration Observed During Dosing Interval (Cmin) of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)||Day 25|Cmin for C-terminus and N-terminus of PF-05231023 and CVX-2000 were not summarized due to the premature termination of the study.|||||
657393|NCT01923389|Secondary|Maximum Plasma Concentration (Cmax) of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)||Days 1 and 25|Cmax for C-terminus and N-terminus of PF-05231023 and CVX-2000 were not summarized due to the premature termination of the study.|||||
657394|NCT01923389|Secondary|Area Under the Concentration Versus Time Curve From Time 0 to Tau, the Dosing Interval (AUCtau) of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)||Days 1 and 25|AUCtau for C-terminus and N-terminus of PF-05231023 and CVX-2000 were not summarized due to the premature termination of the study.|||||
657395|NCT01923389|Primary|Number of Participants With Positive Anti-PF-05231023 Antibodies and Neutralizing Antibodies.|Anti-PF-05231023 antibodies were analyzed using a tiered testing strategy of screen, confirm, and titer characterization. Positive was defined as titer value >=6.23 and negative was defined as titer value <6.23. Samples tested positive were also to be analyzed in a neutralization assay to determine whether or not they were neutralizing or non-neutralizing.|Days 1 up to the last follow-up (Day 68)|All participants who received at least 1 dose of active study medication (PF-05231023). Neutralizing antibodies were not tested because all participants who received PF-05231023 100 mg tested negative for anti-PF-05231023 antibodies.||Participants|||Number
657396|NCT01923389|Secondary|Number of Participants With Abnormal Clinical Laboratory Measurements|The total number of participants with laboratory test abnormalities without regard to baseline abnormality was assessed.|Days -7 up to the last follow-up (Day 68)|All participants who received at least 1 dose of study medication (PF-05231023 or placebo).||Participants|||Number
657397|NCT01923389|Primary|Number of Participants With Electrocardiogram (ECG) Data Met Criteria of Potential Clinical Concern|ECG criteria of potential clinical concern were 1), PR interval:>=300 msec, >=25% increase when baseline >200 msec, or >=50% increase when baseline <=200 msec; 2), QRS interval:>=140 msec, or >=50% increase from baseline; 3), QT interval corrected for heart rate (QTc)/QTc interval using Fridericia’s formula (QTcF):>=500 msec, QTcF interval: absolute value >=450 - <480 msec(borderline), >=480 msec (prolonged), absolute change 30 - <60 msec (borderline) or >=60 msec (prolonged). 12-lead ECG (triplicate) was performed on Day 0 and 12-lead ECG (singlet) was performed at other times.|Days -7 up to the last follow-up (Day 68)|All participants who received at least 1 dose of study medication (PF-05231023 or placebo).||Participants|||Number
657417|NCT01922349|Secondary|RA,Cmax (Accumulation Ratio of the Analyte in Plasma at Steady State After Multiple Oral Administration Over a Uniform Dosing Interval Tau)|Accumulation ratio of the analyte in plasma at steady state after multiple oral administration over a uniform dosing interval tau, expressed as ratio of Cmax at steady state and after single dose|0.25h,0.5h,0.75h,1h,1.5h,2h,2.5h,3h,4h,6h,8h,10h,12h,16h,24h,36h,48h,~72h in SRD and ~24h,~72h,~120h,~168h,~216h,~228h,~264h,~276h,~312h,~312.25h,312.5h,312.75h,313h,313.5h,314h,314.5h,315h,316h,318h,320h,322h,324h,328h,336h,348h,360h,384h in MRD|PKS||Ratio of Cmax||Geometric Coefficient of Variation|Geometric Mean
657398|NCT01923389|Primary|Number of Participants With Vital Signs Data Met Criteria of Potential Clinical Concern|Vital signs included supine systolic blood pressure, diastolic blood pressure and pulse rate. Vital signs criteria of potential clinical concern were 1), blood pressure: systolic greater than or equal to (>=)30 millimeters of mercury (mm Hg) change from baseline in the same posture or systolic less than (<)90 mm Hg; diastolic >=20 mm Hg change from baseline in the same posture or diastolic <50 mm Hg; 2), Pulse rate: supine/Sitting: <40 or greater than (>) 120 beats per minute (bpm); Standing: <40 or >140 bpm.|Days -7 up to the last follow-up (Day 68)|All participants who received at least 1 dose of study medication (PF-05231023 or placebo).||Participants|||Number
657399|NCT01923389|Primary|Number of Participants With Adverse Events (AEs)|An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs were also reported for the 7-day pre-randomization period.|Day -7 through the last follow-up (Day 68)|All participants who received at least 1 dose of study medication (PF-05231023 or placebo).||Participants|||Number
657400|NCT01922986|Secondary|Change in Motricity Index|"Measures strength in finger pinch, elbow flexion and arm abduction. 0 No pinch movement. 11 Slight movement of finger or thumb. 19 Able to grip the cube, but not hold it against gravity. 22 Able to grip and hold the cube against gravity, but not against a weak pull by examiner.
The weighted score based on the ordinal 6 point scale 26 Able to grip and hold the cube against a weak pull, but weaker than the other side.
33 Normal pinch grip.
For shoulder and elbow scoring is:
0 No movement. 9 Palpable contraction in muscle, but no movement. 14 Visible movement, but not full range and not against gravity. 19 Full range of movement against gravity but not against resistance. 25 Full movement against resistance, but weaker than the other side. 33 Normal power. Maximum total score is 99, minimum is 0. Changes that are positive signify improved strength at postte"|Measured at pretest (day before treatments begin) and posttest (day following last treatment). Thus, 7 days of participation (1 pretest, 5 treatments, 1 posttest).|||units on a scale||Standard Deviation|Mean
657401|NCT01922986|Secondary|Change in Finger Tracking Test|This test involves placing a device on the hand that shows the changing angle of the finger joint on a computer screen as the joint is moved. The computer screen also shows a target line, such as a sine wave. At the start of the test, the computer screen cursor moves horizontally across the target and the subject moves the finger joint into extension or flexion to adjust the vertical position of the cursor to that it traces the target line as accurately as possible. The performance is quantified by calculating the root-mean-square error between the target line and the response line. This is converted into an Accuracy Index, which has a maximum value of 100% (perfect score). Negative values can occur and reach a value of -100%, signifying very poor performance. Typical scores for healthy range from 50-80%. Typical values in stroke range from -100 to +40%. Changes that are positive signify increased tracking accuracy at posttest compared to pretest, which would be an improvement.|Measured at pretest (day before treatments begin) and posttest (day following last treatment). Thus, 7 days of participation (1 pretest, 5 treatments, 1 posttest).|||units on a scale||Standard Deviation|Mean
657402|NCT01922986|Primary|Percent Change From Baseline in Jebsen Taylor Hand Function Test Scores|This test quantifies the time it takes for the subject to do the following standardized functional tasks with the hand: stack three checkers, turn over cards, turn over empty cans, turn over fluid-filled cans, pick up and place small items like a paper clip, etc into a can, and use a spoon to scoop up a bean and drop the bean into a can. The unit of measure is time and changes that are negative signify reduced time at posttest compared to pretest, which would be an improvement. Total score = sum of times for each subtests|Measured at pretest (day before treatments begin) and posttest (day following last treatment). Thus, 7 days of participation (1 pretest, 5 treatments, 1 posttest).|||percentage of change from baseline||Standard Deviation|Mean
657403|NCT01922934|Primary|Health Care Utilization - Laboratory Measurements|Evaluation of differences in health care resource utilization between Tool and Control groups during the study period. Health care resource utilization defined as the number of number of lab measurements taken during the period (including A1C, creatinine, and lipids).|1 year study period|||Number of measurements||95% Confidence Interval|Least Squares Mean
657404|NCT01922934|Secondary|Documentation of Obesity|"To assess:
Presence of ICD-9 code for obesity in the DHHA registry Control Group
Evidence of a specific intervention for weight management resembling what was offered in the toolbox intervention: weight loss medication prescribed, gym membership, weight loss program or referral to wt loss specialist, and meal replacements"|1 year study period|Random sample of 120 patient medical records from the DHHA registry Control Group with recorded BMI > or = to 30 plus one comorbidity||Participants|||Count of Participants
657405|NCT01922934|Primary|Health Care Utilization - Non-study Clinic Visits|Evaluation of differences in health care resource utilization between Tool and Control groups during the study period. Health care resource utilization defined as the number of non-study clinic visits.|1 year study period|||Number of visits||95% Confidence Interval|Least Squares Mean
657406|NCT01922934|Primary|Percentage of Participants Who Achieved >5% Weight Loss at 12 Months|Participants who had both a baseline and 12 month weight measurement were included. Weight change at 12 months was measured as a percent difference from their starting weight.|1 year|||percentage of participants|||Number
657407|NCT01922739|Secondary|Percentage of Participants Withdrawn From the Study For Lack of Efficacy|Percentage of patients who withdrew from the study for lack of efficacy, as indicated on the early termination form of the case report form (CRF).|Day 1 of the Titration/Adjustment Period to Week 22 of the Treatment Period (total of 25-26 weeks)|Safety Analysis Set||percentage of participants|||Number
657408|NCT01922739|Secondary|Change From Baseline to Weeks 2, 6, 10, 14, 18, 22 and Endpoint of the Treatment Period in Daily Average Pain Intensity (API) Scores During the Previous 24 Hours for Each Visit|"The API was recorded daily by participants in an electronic diary using an 11-point numerical rating scale (NRS-11), a Likert-type scale in which 0=no pain and 10=the worst pain imaginable. Participants selected the number that best described their average pain intensity over the last 24 hours. Negative change from baseline scores indicate improvement in pain control.
Endpoint refers to the last observation carried forward."|Baseline (Day 0 of Treatment Period), Weeks 2, 6, 10, 14, 18, 22 and Endpoint during the Open-Label Treatment Period|Full Analysis Set includes participants who had at least one post-baseline efficacy assessment. Participants contributing to each time point are counted as part of the number of participants analyzed for that test.||units on a scale||Standard Deviation|Mean
657409|NCT01922739|Secondary|Change From Baseline to Weeks 2, 6, 10, 14, 18, 22 and Endpoint of the Treatment Period in Daily Worst Pain Intensity (WPI) Scores During the Previous 24 Hours for Each Visit|"The WPI was recorded daily by participants in an electronic diary using an 11-point numerical rating scale (NRS-11), a Likert-type scale in which 0=no pain and 10=the worst pain imaginable. At each visit, participants selected the number that best described their worst pain intensity over the last 24 hours. Negative change from baseline scores indicate improvement in pain control.
Endpoint refers to the last observation carried forward."|Baseline (Day 0 of Treatment Period), Weeks 2, 6, 10, 14, 18, 22 and Endpoint during the Open-Label Treatment Period|Full Analysis Set includes participants who had at least one post-baseline efficacy assessment. Participants contributing to each time point are counted as part of the number of participants analyzed for that test.||units on a scale||Standard Deviation|Mean
657410|NCT01922739|Primary|Participants With Clinically Significant (CS) Hearing Changes From Baseline to the Final Visit in Pure Tone Audiometry Test Results|Pure tone audiometry was performed by trained personnel. Hearing loss was classified in degrees of hearing from normal to profound. This classification was determined by the hearing threshold (or the softest sound detected at a specific frequency). The exact ranges that classified hearing loss depended on the exact technique used during testing and on the patient's age. These values were provided by each audiology laboratory that performed the test. For serial audiograms, the criteria for a clinically significant hearing change were based on guidance from the American Speech Language Hearing Association (ASHA 1994, cited in [Konrad-Martin et al 2005]). These criteria included the following: greater than 20 decibels (dB) pure tone threshold shift at 1 frequency; greater than 10 dB shift at 2 consecutive test frequencies; or threshold response shifting to “no response” at 3 consecutive test frequencies.|Baseline was within two weeks of the final study visit in study 3103; during study exam was within two weeks of the end of trial visit for study 3104 (up to study week 26)|Safety Analysis Set||Participants|||Count of Participants
657411|NCT01922739|Primary|Shifts From Baseline to Endpoint (Treatment Period) in Electrocardiogram (ECG) Findings|"A 12-lead ECG was conducted at the final visit for study 3103 which is used as baseline for this study, and at week 22 of the treatment period [or early termination]). A qualified physician at the study center was responsible for providing interpretation of the ECG.
Endpoint refers to the last observation carried forward."|Baseline (final visit for study 3103), End of trial visit (up to week 22 of Open-label Treatment Period which is up to week 26 including the titration/adjustment period)|Post-Titration Safety Analysis Set. Includes participants who have both baseline and endpoint data.||Participants|||Count of Participants
657412|NCT01922739|Primary|Participants With Shifts From Normal to Abnormal in Physical Examination Findings|The endpoint visit or early termination visit was an abbreviated exam. Endpoint refers to the last observation carried forward.|End of trial visit (up to week 22 of Open-label Treatment Period which is up to week 26 including the titration/adjustment period)|Post-Titration Safety Analysis Set||Participants|||Count of Participants
657413|NCT01922739|Primary|Participants With Potentially Clinically Significant Abnormal Vital Signs Values|"Data represents participants with potentially clinically significant (PCS) vital sign values.
Significance criteria
Pulse - high: >=120 and increase of >= 15 beats/minute from baseline
Pulse - low: <=50 and decrease of >=15 beats/minute
Systolic blood pressure - high: >=180 and increase >=20 mmHg
Systolic blood pressure - low: <=90 and decrease >=20 mmHg
Diastolic blood pressure - high: >=105 and increase of >=15 mmHg
Diastolic blood pressure - low: <=50 and decrease of >=15 mmHg"|Day 1 of the Titration/Adjustment Period to Week 22 of the Treatment Period (total of 25-26 weeks)|The Full Analysis Set includes all participants who took at least one dose of study drug and who had at least 1 post-baseline efficacy assessment. Participants with a post-baseline vital sign result are counted as part of the number of participants analyzed.||Participants|||Count of Participants
657414|NCT01922739|Primary|Participants With Potentially Clinically Significant Abnormal Laboratory Values|"Data represents participants with potentially clinically significant abnormal serum chemistry, hematology and urinalysis values.
Significance criteria:
Blood urea nitrogen: >=10.71 mmol/L
Creatinine: >=177 μmol/L
Uric acid: M>=625, F>=506 μmol/L
Aspartate aminotransferase (AST): >=3* upper limit of normal (ULN)
Alkaline phosphatase: >=3* upper limit of normal (ULN)
Gamma-glutamyl transpeptidase (GGT): >=3* upper limit of normal (ULN)
Serum white blood cells: >=20 * 10^9/L
Hemoglobin: M<=115, F<=95 g/dL
Hematocrit: M<0.37, F<0.32 L/L
Eosinophils: >=10.0 %
Platelets: <=75 * 10^9/L
Absolute neutrophils: <=1.0 * 10^9/L
Urinalysis: Glucose, Ketones, and Total Protein: >=2 unit increase from baseline"|End of trial visit (up to week 22 of Open-label Treatment Period which is up to week 26 including the titration/adjustment period)|The Full Analysis Set includes all participants who took at least one dose of study drug and who had at least 1 post-baseline efficacy assessment. Participants with a post-baseline result for each test are counted as part of the number of participants analyzed for that test.||Participants|||Count of Participants
657415|NCT01922739|Primary|Participants With Adverse Events|An adverse event (AE) was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an inability to carry out usual activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 of the Titration/Adjustment Period to Week 22 of the Treatment Period (total of 25-26 weeks)|Safety Analysis Set for the Titration/Adjustment period; Post-Titration/Post-Adjustment Safety Analysis Set for the Open-Label Treatment Period||Participants|||Count of Participants
657416|NCT01922349|Secondary|RA,AUC (Accumulation Ratio of the Analyte in Plasma at Steady State After Multiple Dose Administration Over a Uniform Dosing Interval Tau)|Accumulation ratio of the analyte in plasma at steady state after multiple dose administration over a uniform dosing interval tau, expressed as ratio of AUC at steady state and after single dose|0.25h,0.5h,0.75h,1h,1.5h,2h,2.5h,3h,4h,6h,8h,10h,12h,16h,24h,36h,48h,~72h in SRD and ~24h,~72h,~120h,~168h,~216h,~228h,~264h,~276h,~312h,~312.25h,312.5h,312.75h,313h,313.5h,314h,314.5h,315h,316h,318h,320h,322h,324h,328h,336h,348h,360h,384h in MRD|PKS||Ratio of AUC||Geometric Coefficient of Variation|Geometric Mean
658374|NCT01903863|Secondary|Hemorrhagic and Thrombotic Complications|Complications associated with coagulation in both the patient and the pump will be collected.|ECMO course (median 198 hours)|||participants|||Number
657418|NCT01922349|Secondary|t1/2,ss|Terminal half-life of the analyte in plasma at steady state|23.92h, 71.92h, 119.92h, 167.92h, 215.92h, 227.92h, 263.92h, 275.92h, 311.92h, 312.25h, 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h, 348h, 360h, 384h|PKS||hours||Geometric Coefficient of Variation|Geometric Mean
657419|NCT01922349|Secondary|AUCtau,ss|Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval tau|23.92h, 71.92h, 119.92h, 167.92h, 215.92h, 227.92h, 263.92h, 275.92h, 311.92h, 312.25h, 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h, 348h, 360h, 384h|PKS||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
657420|NCT01922349|Secondary|Tmax,ss|Time from last dosing to maximum concentration of the analyte in plasma at steady state|23.92h, 71.92h, 119.92h, 167.92h, 215.92h, 227.92h, 263.92h, 275.92h, 311.92h, 312.25h, 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h, 348h, 360h, 384h|PKS||hours||Full Range|Median
657421|NCT01922349|Secondary|Cmax,ss|Maximum measured concentration of the analyte in plasma at steady state|23.92h, 71.92h, 119.92h, 167.92h, 215.92h, 227.92h, 263.92h, 275.92h, 311.92h, 312.25h, 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h, 348h, 360h, 384h|PKS||nmol/L||Geometric Coefficient of Variation|Geometric Mean
657422|NCT01922349|Secondary|t1/2 (Terminal Half-life of the Analyte in Plasma After the First Dose)|Terminal half-life of the analyte in plasma after a single dose of BI 113608.|0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 71.75h after drug administration|PKS||hours||Geometric Coefficient of Variation|Geometric Mean
657423|NCT01922349|Secondary|AUC0-tz (Area Under the Concentration-time Curve of the Analyte in Plasma From Time 0 to Time of Last Quantifiable Data Point)|Area under the concentration-time curve of the analyte in plasma from time 0 to time of last quantifiable data point after a single dose of BI 113608.|0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 71.75h after drug administration|The PK analysis set (PKS) included all subjects of the TS who provided at least 1 secondary PK endpoint in any dose period, which was judged as PK evaluable and was not affected by important protocol violation(s) relevant to the statistical evaluation of PK endpoints.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
657424|NCT01922349|Secondary|Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity)|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity after a single dose of BI 113608.|0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 71.75h after drug administration|The PK analysis set (PKS) included all subjects of the TS who provided at least 1 secondary PK endpoint in any dose period, which was judged as PK evaluable and was not affected by important protocol violation(s) relevant to the statistical evaluation of PK endpoints.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
657425|NCT01922349|Secondary|Tmax (Time From Dosing to Maximum Measured Concentration in Plasma)|Time from dosing to maximum measured concentration in plasma after a single dose of BI 113608.|0.25 hours (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 71.75h after drug administration|The PK analysis set (PKS) included all subjects of the TS who provided at least 1 secondary PK endpoint in any dose period, which was judged as PK evaluable and was not affected by important protocol violation(s) relevant to the statistical evaluation of PK endpoints.||hour||Full Range|Median
657426|NCT01922349|Secondary|Cmax (Maximum Measured Concentration of the Analyte in Plasma)|maximum measured concentration of the analyte in plasma after a single dose of BI 113608.|0.25 hours (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 71.75h after drug administration|The PK analysis set (PKS) included all subjects of the TS who provided at least 1 secondary PK endpoint in any dose period, which was judged as PK evaluable and was not affected by important protocol violation(s) relevant to the statistical evaluation of PK endpoints.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
657427|NCT01922349|Primary|Number (%) of Subjects With Drug-related Adverse Events|Percentage of subjects with drug-related adverse events (AE) in the SRD and MRD periods combined. The investigator assessed the possible causal relationship between an AE and the trial medication.|Up to 21 days (4 days for SRD period and 17 days for MRD period)|Treated set (TS)||Percentage of participants|||Number
657428|NCT01922271|Secondary|Inspiratory Capacity (IC)|Inspiratory Capacity (IC) is the volume of air breathed in by a maximum inspiration at the end of a normal expiration. Whole body plethysmography (Bodybox) will be used to measure IC.|Day 1|The Full Analysis Set (FAS) consisted of all randomized patients who applied at least one dose of study medication during at least one study period.||Liters||Standard Deviation|Mean
657429|NCT01922271|Secondary|Total Lung Capacity (TLC)|Total Lung Capacity (TLC) is the best vital capacity plus residual volume (RV). Whole body plethysmography (Bodybox) will be used to measure TLC.|Day 1|The Full Analysis Set (FAS) consisted of all randomized patients who applied at least one dose of study medication during at least one study period.||Liters||Standard Deviation|Mean
657430|NCT01922271|Secondary|Residual Volume (RV)|Residual Volume (RV) will be measured using whole body plethysmography (Bodybox).|Day 1|The Full Analysis Set (FAS) consisted of all randomized patients who applied at least one dose of study medication during at least one study period.||Liters||Standard Deviation|Mean
657431|NCT01922271|Secondary|Functional Resistance Capacity (FRCpleth)|Functional Resistance Capacity (FRCpleth) will be measured using whole body plethysmography (Bodybox).|Day 1|The Full Analysis Set (FAS) consisted of all randomized patients who applied at least one dose of study medication during at least one study period.||Liters||Standard Deviation|Mean
657432|NCT01922271|Secondary|Specific Airway Resistance (sRAW)|Specific Airway Resistance (sRAW) indicates volume and resistance-dependent work of breathing needed in order to generate a reference flow rate of 1 L/s, measured by kPa*s. Whole body plethysmography (Bodybox) is used to measure SRaw.|Day 1|The Full Analysis Set (FAS) consisted of all randomized patients who applied at least one dose of study medication during at least one study period.||kilopascal (kPa)||Standard Deviation|Mean
657459|NCT01921894|Primary|Number of Participants With Vitamin D Sufficiency (Vitamin D ≥30 ng/ml) After 4 Weeks of Supplementation|The outcome is defined as the number of participants with a sufficient (≥30 ng/ml) vitamin D level after 8 weeks of supplementation|4 weeks|The characteristics of the study population are the same as described for the other primary outcome (vitamin D sufficiency at 8 weeks)||participants|||Number
657433|NCT01922271|Secondary|Forced Expiratory Volume in One Second (FEV1) 15 Min Post Dose|Forced expiratory volume in 1 second (FEV1) is the amount of air that can be exhaled in one second. FEV1 will be measured by spirometry. All spirometry calibrations and evaluations will follow the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability.|Day 1|The Full Analysis Set (FAS) consisted of all randomized patients who applied at least one dose of study medication during at least one study period.||liters per hour||Standard Deviation|Mean
657434|NCT01922271|Primary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve (AUC) 0-2|Standardized Forced Expiratory Volume in One Second (FEV1) AUC0-2h will be measured via spirometry. The AUC will be calculated from the FEV1 measurements obtained at timepoints between 0 min and 2h using the trapezoidal rule and will be standardized (=divided) by the measurement time (i.e. 2h).|Day 1|The Full Analysis Set (FAS) consisted of all randomized patients who applied at least one dose of study medication during at least one study period.||liters per hour||Standard Deviation|Mean
657435|NCT01922219|Secondary|Final Score on the Hamilton Depression Rating Scale|"Final score on the Hamilton Depression Rating Scale (HDRS) was calculated for 37 patients who were treated with Cognitive Behavioral Therapy.
The 17-item HDRS is a clinician-administered scale that quantifies depression severity, and includes items assessing mood, suicidal thinking, insomnia, feelings of guilt, work and activities, somatic symptoms, and insight. It is a well-characterized scale with excellent psychometric properties. The total score is the sum of the individual scores of the 17 scale items. Higher scores indicate greater depression severity. When using this outcome measure, we covary for baseline HDRS scores. Published norms for interpretation of the 17-item HDRS use a different version of the scale with a total possible score of 52, and are listed below. Interpretation is comparable (but not identical) with the 17-item HDRS version used in this study, which has a maximum score is 51.
None: 0-7 Mild: 8-13 Moderate: 14-19 Severe: 20-25 Very Severe: 26-52"|Post-Treatment, up to 12 weeks|||units on a scale||Standard Deviation|Mean
657436|NCT01922219|Secondary|Post-Treatment Beck Depression Inventory|"The Beck Depression Inventory is a self-report measure of depression severity that is a well-characterized scale with excellent psychometric properties and is frequently used in research studies of depression.
The scale measures symptoms related to sadness, pessimism, past failure, loss of pleasure, guilty feelings, punishment feelings, self-dislike, self-criticalness, suicidal thoughts or wishes, crying, agitation, loss of interest, indecisiveness, worthlessness, loss of energy, changes in sleeping pattern, irritability, changes in appetite, concentration difficulty, tiredness or fatigue, and loss of interest in sex.
We report the total score on the BDI, which has a range of 0 to 63. Higher values represent greater severity of depression. The following score interpretations are provided in the scale’s manual:
0-9 minimal depression 10-18 mild depression 19-29 moderate depression 30-63 severe depression"|Post-Treatment, up to 12 weeks|||Score on a scale||Standard Deviation|Mean
657437|NCT01922219|Primary|Remitters as Assessed by Post-treatment Beck Depression Inventory Less Than or Equal to 10|The primary outcome of this study is remission from depression at the conclusion of 12 weeks of cognitive behavioral therapy for depression. This will be assessed using the Beck Depression Inventory, a self-report questionnaire of symptoms of depression that will be administered at every treatment visit. Remission is defined by a final Beck Depression Inventory score less than or equal to 10.|12 weeks|||Participants|||Count of Participants
657438|NCT01922115|Primary|Hopkins Verbal Learning Test - Revised|Assesses short term verbal learning and memory. See below for the subscale delayed recognition (0-24). Percentages of total responses correct are reported for delayed recognition, higher values indicate better outcomes.|Week 4|||percentage of total correct||Standard Deviation|Mean
657439|NCT01922115|Secondary|Overactive Bladder Questionnaire|The Overactive Bladder Questionnaire (OAB-q) was developed to assess symptom bother and the impact of overactive bladder (OAB) on health-related quality of life (HRQL). The instrument was developed and validated in both continent and incontinent OAB patients, including both men and women. Total range is 19-101 and higher values indicate worse outcomes.|Week 4|||units on a scale||Standard Deviation|Mean
657440|NCT01922115|Secondary|Mini–Mental State Examination|The mini–mental state examination (MMSE) or Folstein test is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. It is commonly used in medicine and allied health to screen for dementia. The range is 0-30, with higher values indicating better outcomes.|Week 4|||units on a scale||Standard Deviation|Mean
657441|NCT01922115|Primary|Hopkins Verbal Learning Test - Revised|Assesses short term verbal learning and memory. Subscales include immediate recall (0-36) and delayed recall (0-12). Higher values indicate better outcomes.|Week 4|||units on a scale||Standard Deviation|Mean
657442|NCT01922089|Secondary|Number of Participants Who Tolerated Study Medication for at Least the Last Two Weeks of the Study and by Renin-Angiotensin-Aldosterone System (RAAS) Stratum (High vs. Low).|Tolerability was assessed as the number of participants who achieved LCZ696 200 mg bid and maintained this dose for at least 2 weeks before study completion, regardless of previous dose interruption or down-titration and by Renin-Angiotensin-Aldosterone System (RAAS) stratum (high vs. low) High RAAS stratum Patients receiving > 160 mg of valsartan or > 10 mg total daily dose of enalapril, or equivalent doses of other ARBs/ACEIs, respectively, at screening Low RAAS stratum: Patients receiving ≤ 160 mg of valsartan or ≤ 10 mg total daily dose of enalapril, or equivalent doses of other ARBs/ACEIs, respectively, at screening. This stratum also included patients who were not on an ACEI or an ARB 4 weeks prior to screening (i.e., ACEI/ARB-naïve patients)|12 weeks|Evaluable patients in FAS with the exception of misrandomized patients who didn’t received drug, but had been randomized into the study, excluding patients who discontinued the study prior to completion of 12 wks. Following the intent-to-treat principle, patients were analyzed according to the treatment to which they were assigned at randomization.||participants|||Number
657460|NCT01921894|Secondary|Number of Participants With FEV1 < 80% of Predicted|Forced expiratory volume in 1 second (FEV1) as percent predicted (with reference values used according to the child's age, gender and ethnicity).|8 weeks|We wanted to compare the proportion of subjects whose FEV1 % predicted fell below 80% predicted across the three arms in this pilot Phase I study.||participants|||Number
657461|NCT01921894|Secondary|Number of Participants With Elevated Urinary Calcium/Creatinine Ratio|Elevated urinary calcium/creatinine ratio defined as UCa/UCr > 0.37 after either 4 weeks or 8 weeks of supplementation|4 and/or 8 weeks|We wanted to compare the proportion of subjects who had an elevated UCa/UCr ratio across the three groups in this pilot Phase I Study||participants|||Number
657443|NCT01922089|Secondary|Number of Participants Who Achieved Treatment Success Over the 12 Weeks and by Renin-Angiotensin-Aldosterone System (RAAS) Stratum (High vs. Low)|Treatment success was defined as the number of participants who achieved and maintained LCZ696 200 mg bid without any dose interruption or down-titration over 12 weeks and by Renin-Angiotensin-Aldosterone System (RAAS) stratum (high vs. low) High RAAS stratum Patients receiving > 160 mg of valsartan or > 10 mg total daily dose of enalapril, or equivalent doses of other ARBs/ACEIs, respectively, at screening Low RAAS stratum: Patients receiving ≤ 160 mg of valsartan or ≤ 10 mg total daily dose of enalapril, or equivalent doses of other ARBs/ACEIs, respectively, at screening. This stratum also included patients who were not on an ACEI or an ARB 4 weeks prior to screening (i.e., ACEI/ARB-naïve patients)|12 weeks|Evaluable patients in FAS with the exception of misrandomized patients who didn’t received drug, but had been randomized into the study, excluding patients who discontinued the study prior to completion of 12 wks. Following the intent-to-treat principle, patients were analyzed according to the treatment to which they were assigned at randomization.||participants|||Number
657444|NCT01922089|Primary|Number of Participants Experiencing Hypotension, Renal Dysfunction, Hyperkalemia and Angioedema and by Renin-Angiotensin-Aldosterone System (RAAS) Stratum (High vs. Low)|Participants experiencing hypotension, renal dysfunction, hyperkalemia and angioedema and by Renin-Angiotensin-Aldosterone System (RAAS) stratum (high vs. low) High RAAS stratum Patients receiving > 160 mg of valsartan or > 10 mg total daily dose of enalapril, or equivalent doses of other ARBs/ACEIs, respectively, at screening Low RAAS stratum: Patients receiving ≤ 160 mg of valsartan or ≤ 10 mg total daily dose of enalapril, or equivalent doses of other ARBs/ACEIs, respectively, at screening. This stratum also included patients who were not on an ACEI or an ARB 4 weeks prior to screening (i.e., ACEI/ARB-naïve patients)|12 weeks|Full Analysis Set (FAS) consisted of all randomized patients with the exception of mis-randomized patients who had not received the study drug, but had been inadvertently randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment to which they were assigned at randomization.||participants|||Number
657445|NCT01922011|Other Pre-specified|Plasma Concentration of Daptomycin at 4 to 5 Hours After the End of IV Infusion|Blood samples were collected, after infusion of IV study drug between the end of infusion on study day 3, up to Day 42|Day 3 up to Day 42|Participants who received a known amount of daptomycin and who had at least one blood sample collected. Participants treated with vancomycin, nafcillin or equivalent were not analyzed.||µg/mL||Standard Deviation|Mean
657446|NCT01922011|Other Pre-specified|Plasma Concentration of Daptomycin at 2 to 3 Hours After the End of IV Infusion|Blood samples were collected, after infusion of IV study drug between the end of infusion on study day 3, up to Day 42|Day 3 up to Day 42|Participants who received a known amount of daptomycin and who had at least one blood sample collected. Participants treated with vancomycin, nafcillin or equivalent were not analyzed.||µg/mL||Standard Deviation|Mean
657447|NCT01922011|Other Pre-specified|Plasma Concentration of Daptomycin at 15 Minutes to 1 Hour After the End of IV Infusion|Blood samples were collected, after infusion of IV study drug between the end of infusion on study day 3, up to Day 42|Day 3 up to Day 42|Participants who received a known amount of daptomycin and who had at least one blood sample collected. Participants treated with vancomycin, nafcillin or equivalent were not analyzed.||µg/mL||Standard Deviation|Mean
657448|NCT01922011|Other Pre-specified|Plasma Concentration of Daptomycin at the End of IV Infusion|Blood samples were collected, after infusion of IV study drug between the end of infusion on study day 3, up to Day 42|Day 3 up to Day 42|Participants who received a known amount of daptomycin and who had at least one blood sample collected. Participants treated with vancomycin, nafcillin or equivalent were not analyzed.||µg/mL||Standard Deviation|Mean
657449|NCT01922011|Other Pre-specified|Change From Baseline in Number of Participants With Abnormal Focused (Peripheral) Neurological Assessments|Focused neurological examinations include assessments of alertness, sensation, pupillary reflex and tracking, peripheral reflexes (biceps, patellar tendon, ankle jerk, and plantar response), muscle tone and strength (upper and lower limbs), coordination (finger to nose), and tremor of the hands/fingers.|Baseline and up to Test of Cure (21-35 days after last dose of IV study drug) (up to Day 77)|Data were only summarized for each visit; but not analyzed.|||||
657450|NCT01922011|Other Pre-specified|Concentration of Serum Creatine Kinase (CK)|Serum was collected at Baseline and at End of Therapy IV, from which the concentration of CK was determined.|Baseline and End of Therapy IV (up to Day 42)|Treated participants based on the treatment received||U/L||Standard Deviation|Mean
657451|NCT01922011|Other Pre-specified|Number of Participants With 1 or More Serious Adverse Events (SAEs)|An SAE is any untoward medical occurrence that at any dose results in death; is life threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or is a congenital anomaly/birth defect.|Administration of first dose through the last follow-up visit; an expected time of up to 6.5 months|Treated participants based on the treatment received||Participants|||Number
657452|NCT01922011|Other Pre-specified|Number of Participants With 1 or More Adverse Events (AEs)|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, clinically significant laboratory finding, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product|Administration of first dose up to approximately six and a half months after last dose of study drug|Treated participants based on the treatment received||Participants|||Number
657462|NCT01921894|Secondary|Number of Participants With Vitamin D Toxicity|Participants with vitamin D toxicity, hypercalcemia (>10.8mg/dl) and/or an elevated urine Ca/Cr ratio (>0.37)|8 weeks|We wanted to report and compare the proportion of subjects who had vitamin D toxicity, hypercalcemia or an elevated UCa/UCr ratio across the three treatment arms||participants|||Number
657463|NCT01921894|Primary|Number of Participants With Sufficient Vitamin D Levels (≥30 ng/ml) After 8 Weeks of Supplementation|The primary outcome of the proposed trial will be a sufficient (≥30 ng/ml) vitamin D level after 8 weeks of supplementation|8 weeks|In this pilot study, we wanted to report and compare the proportion of subjects who achieved vitamin D sufficiency after 8 weeks of treatment with one of three vitamin D doses.||participants|||Number
657464|NCT01921829|Other Pre-specified|Adverse Events|Hypokalemia (K <3.0 milliequivalents (mEq)/L), hypotension (systolic BP <90 mmHg), hyponatremia (Na <130 mEq/L), arrhythmias, cramps, and other (recorded as short description).|Daily while in hospital , 1 mo, & 3 mos|||events||Standard Deviation|Mean
657453|NCT01922011|Secondary|Percentage of Participants With a Favorable Microbiological Response Categorized by Baseline Pathogen at Test of Cure|Favorable microbiological outcomes are either eradication where the source specimen demonstrated absence of the original baseline pathogen; or presumed eradication where the source specimen was not available to culture, and the subject was assessed as a clinical cure. For a favorable microbiological response, the outcome for each baseline pathogen must be eradicated or presumed eradicated. Other pathogens include Arcanobacterium haemolyticum, Gram positive cocci, Staphylococcus epidermidis, Streptococcus dysgalactiae, Streptococcus mitis group and Streptococcus pyogenes.|Baseline (within 48 hours prior to first dose of IV study drug) - and Test of Cure (21-35 days after last dose of IV study drug) (up to Day 77)|All randomized participants who received IV study drug and had a confirmed diagnosis of AHO, excluding participants with confirmed culture of a gram-negative organism; but including those where at least one bacterial pathogen was isolated from an appropriate microbiological specimen at baseline.||Percentage of participants||95% Confidence Interval|Number
657454|NCT01922011|Secondary|Percentage of Participants With Sustained Clinical Improvement|Sustained clinical improvement was defined as participants with clinical improvement who further met the definition of clinical cure. Clinical improvement was in the three general categories of Pain, Inflammation, and Limb Function on or before Study Day 5. Clinical cure is defined as resolution of all acute symptoms of AHO or improvement to such an extent that no further intravenous antibacterial therapy is required. The EOT visit is within 48 hours of last dose of PO therapy.|Baseline (within 48 hours prior to first dose of IV study drug) - up to Test of Cure (21-35 days after last dose of IV study drug) (up to Day 77)|All randomized participants who received any amount of IV study drug and who had a confirmed or suspected diagnosis of AHO, excluding those with confirmed culture of a gram-negative organism from any baseline specimen; and had non-missing clinical outcome.||Percentage of participants||95% Confidence Interval|Number
657455|NCT01922011|Secondary|Percentage of Participants With a Clinical Cure Categorized by Baseline Pathogen at Test of Cure|At Test Of Cure (TOC) clinical cure is defined as resolution of all acute symptoms of AHO or improvement to such an extent that no further antibacterial therapy is required. Favorable microbiological outcomes are either eradication where the source specimen demonstrated absence of the original baseline pathogen; or presumed eradication where the source specimen was not available to culture, and the subject was assessed as a clinical cure. To have a favorable microbiological response, the outcome for each participant's baseline pathogen must be favorable (eradicated or presumed eradicated). Other pathogens include Arcanobacterium haemolyticum, Gram positive cocci, Staphylococcus epidermidis, Streptococcus dysgalactiae, Streptococcus mitis group and Streptococcus pyogenes.|Baseline (within 48 hours prior to first dose of IV study drug) - and Test of Cure (21-35 days after last dose of IV study drug) (up to Day 77)|All randomized participants who received IV study drug and had a confirmed diagnosis of AHO, excluding participants with confirmed culture of a gram-negative organism; but including those where at least one bacterial pathogen was isolated from an appropriate microbiological specimen at baseline.||Percentage of participants||95% Confidence Interval|Number
657456|NCT01922011|Secondary|Percentage of Participants With a Favorable Clinical Outcome|Favorable clinical outcomes are clinical recovery and clinical cure. Clinical cure is defined as resolution of all acute symptoms of AHO or improvement to such an extent that no further intravenous antibacterial therapy is required. Clinical recovery is defined as clinical improvement in the composite end point three general categories of Pain, Inflammation, and Limb Function on or before Study Day 5, and no development of new symptoms of AHO; body temperature ≤ 38°C (100.4°F) for 24 hours; no new or additional bone or joint infection (e.g., abscess, spreading to other osseous or articular locations) such that no further antibacterial therapy or surgery are required; no hematogenous metastatic infection (e.g., abscess in liver, spleen, lung; other bones) or bacteremia.. The End of Therapy (EOT) visit is within 48 hours of last dose of PO therapy.|Baseline (within 48 hours prior to first dose of IV study drug) - and up to Test of Cure (21-35 days after last dose of IV study drug) (up to Day 77)|All randomized participants who received any amount of IV study drug and who had a confirmed diagnosis of AHO (Categories I, II and III), excluding participants with confirmed culture of a gram-negative organism from any baseline specimen||Percentage of participants||95% Confidence Interval|Number
657457|NCT01922011|Secondary|Percentage of Participants With Clinical Improvement Measured as a Composite End Point of Pain, Inflammation, Limb Function, Body Temperature, and C-reactive Protein at End-of IV (EOIV) Therapy Visit.|A participant had a favorable outcome in this composite endpoint if all 3 of the following criteria were met: Clinical improvement in the general symptom categories of Pain, Inflammation, and Limb Function on or before Study Day 5; Body temperature ≤ 38°C (100.4°F) over the preceding 24 hours; and C-reactive Protein (CRP) decreased from baseline for participants who had a baseline CRP >ULN (upper limit of normal)) or remain <=ULN for participants who had a baseline <=ULN on or before Study Day 5. The EOIV visit is within 24 hours after the last dose of IV study drug and before switch to optional open label (PO) therapy, if applicable.|Up to study Day 5|All randomized participants who received any amount of IV study drug and who had a confirmed diagnosis of AHO (Categories I, II and III), excluding participants with confirmed culture of a gram-negative organism from any baseline specimen and who did not have all clinical assessments performed at the time point.||Percentage of participants||95% Confidence Interval|Number
657458|NCT01922011|Primary|Percentage of Participants With Clinical Improvement in the 3 General Categories of Pain, Inflammation, and Limb Function Based on the Investigator's Overall Assessment of Severity of Each of the Symptom Categories.|Clinical improvement was based on the Investigator’s overall assessment of severity of each of the 3 general symptom categories of Pain, Inflammation, and Limb Function. Based on this evaluation, a participant was considered to have met criteria for clinical improvement according to the following definition: If 3 general categories are present at baseline: at least a 1-point improvement (i.e. severe to moderate, moderate to mild, mild to absent) in at least 2 of the general categories and no worsening in the other. If 2 general categories are present at baseline: at least a 2-point improvement (i.e. severe to mild, moderate to absent) in at least 1 of the general categories and no worsening or new findings in the others OR at least a 1-point improvement in both and no new findings in the other. If 1 general category is present at baseline: at least a 2-point improvement (i.e., severe to mild, moderate to absent) in that category and no new findings in the others.|Up to study Day 5|All randomized participants who received any amount of IV study drug and who had a confirmed or suspected diagnosis of AHO, excluding those with confirmed culture of a gram-negative organism from any baseline specimen.||Percentage of participants||95% Confidence Interval|Number
657465|NCT01921829|Secondary|PSQI Total Score Change at 3 Months|The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score, and takes 5–10 minutes to complete. Consisting of 19 items, the PSQI measures several different aspects of sleep, offering seven component scores and one composite score. The component scores consist of subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each item is weighted on a 0–3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality. Traditionally, the items from the PSQI have been summed to create a total score to measure overall sleep quality.|Baseline to 3 months|||units on a scale||Standard Deviation|Mean
657466|NCT01921829|Secondary|PHQ-9 Depression Index Change at 3 Months|"The Patient Health Questionnaire (PHQ-9) Depression Index is a well-established index of depression and has been validated in many patient populations. Its scoring ranges from 0-27 with increasing scores representing increasing depression severity. Score categories determine depression severity and recommended management:
0-4 - Minimal or none. Monitor; may not require treatment. 5-9 - Mild. Use clinical judgment (symptom duration, functional impairment) to determine necessity of treatment.
10-14 - Moderate. Use clinical judgment (symptom duration, functional impairment) to determine necessity of treatment.
15-19 - Moderately severe. Warrants active treatment with psychotherapy, medications, or combination.
20-27 - Severe. Warrants active treatment with psychotherapy, medications, or combination."|Baseline to 3 months|||units on a scale||Standard Deviation|Mean
657467|NCT01921829|Secondary|SF-36 Physical Component Score (PCS) Change at 3 Months|The Medical Outcomes Study (MOS) 36-item Short-Form Health Survey (SF-36) is a well-validated generic HRQOL questionnaire that generates two composite scores: the Physical Component Score (PCS) and Mental Component Score (MCS). The PCS aggregates items from Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, and Social Functioning. The MCS aggregates items from Role-Emotional, Mental Health, General Health, Vitality, and Social Functioning. The mean for each summary scale is 50 points with standard deviation of 10 points. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.|Baseline to 3 months|||units on a scale||Standard Deviation|Mean
657468|NCT01921829|Secondary|SF-36 Mental Component Score (MCS) Change at 3 Months|The Medical Outcomes Study (MOS) 36-item Short-Form Health Survey (SF-36) is a well-validated generic HRQOL questionnaire that generates two composite scores: the Physical Component Score (PCS) and Mental Component Score (MCS). The PCS aggregates items from Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, and Social Functioning. The MCS aggregates items from Role-Emotional, Mental Health, General Health, Vitality, and Social Functioning. The mean for each summary scale is 50 points with standard deviation of 10 points. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.|Baseline to 3 months|||units on a scale||Standard Deviation|Mean
657469|NCT01921829|Secondary|Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Score Change at 3 Months|The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a well-validated 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. An overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. A mean difference over time of 5 points on the KCCQ Overall Summary Scale reflects a clinically significant change in heart failure status. A 10 point decline in KCCQ scores has important prognostic significance in terms of survival.|Baseline to 3 months|||units on a scale||Standard Deviation|Mean
657470|NCT01921829|Secondary|Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Score Change at 3 Months|The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a well-validated 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. An overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. A mean difference over time of 5 points on the KCCQ Overall Summary Scale reflects a clinically significant change in heart failure status. A 10 point decline in KCCQ scores has important prognostic significance in terms of survival.|Baseline to 3 months|||units on a scale||Standard Deviation|Mean
657471|NCT01921829|Secondary|PSQI Total Score Change at 1 Month|The Pittsburgh Sleep Quality Index (PSQI) is the most widely used global sleep assessment and has been studied in the renal transplant population. Consisting of 19 items, the PSQI measures several different aspects of sleep, offering seven component scores and one composite score. The component scores consist of subjective sleep quality, sleep latency (i.e., how long it takes to fall asleep), sleep duration, habitual sleep efficiency (i.e., the percentage of time in bed that one is asleep), sleep disturbances, use of sleeping medication, and daytime dysfunction. Each item is weighted on a 0–3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality. Traditionally, the items from the PSQI have been summed to create a total score to measure overall sleep quality.|Baseline to 1 month|||units on a scale||Standard Deviation|Mean
657483|NCT01921829|Secondary|Length of Hospitalization|Length of hospitalization will be ascertained from admission date to date of discharge.|1 month|One participant from the ProDiuS arm withdrew consent before undergoing any randomized treatment.||days||Standard Deviation|Mean
658998|NCT01890577|Secondary|Hemoglobin Within the Range 10-12 g/dL Over Time|Due to the premature termination of the study no outcome measure data were analyzed.|On a continuous basis over the 15-month observation period||||||
657472|NCT01921829|Secondary|PHQ-9 Depression Index Change at 1 Month|"The Patient Health Questionnaire (PHQ-9) Depression Index is a well-established index of depression and has been validated in many patient populations. Its scores range from 0-27 with increasing scores representing increasing depression severity. Score categories represent depression severity and management recommendations:
0-4 - Minimal or no depression. Monitor; may not require treatment. 5-9 - Mild. Use clinical judgment (symptom duration, functional impairment) to determine necessity of treatment.
10-14 - Moderate. Use clinical judgment (symptom duration, functional impairment) to determine necessity of treatment.
15-19 - Moderately severe. Warrants active treatment with psychotherapy, medications, or combination.
20-27 - Severe. Warrants active treatment with psychotherapy, medications, or combination."|Baseline to 1 month|||units on a scale||Standard Deviation|Mean
657473|NCT01921829|Secondary|SF-36 Physical Component Score (PCS) Change at 1 Month|The Medical Outcomes Study (MOS) 36-item Short-Form Health Survey (SF-36) is a well-validated generic HRQOL questionnaire that generates two composite scores: the Physical Component Score (PCS) and Mental Component Score (MCS). The PCS aggregates items from Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, and Social Functioning. The MCS aggregates items from Role-Emotional, Mental Health, General Health, Vitality, and Social Functioning. The mean for each summary scale is 50 points with standard deviation of 10 points. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.|Baseline to 1 month|||units on a scale||Standard Deviation|Mean
657474|NCT01921829|Secondary|SF-36 Mental Component Score (MCS) Change at 1 Month|The Medical Outcomes Study (MOS) 36-item Short-Form Health Survey (SF-36) is a well-validated generic HRQOL questionnaire that generates two composite scores: the Physical Component Score (PCS) and Mental Component Score (MCS). The PCS aggregates items from Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, and Social Functioning. The MCS aggregates items from Role-Emotional, Mental Health, General Health, Vitality, and Social Functioning. The mean for each summary scale is 50 points with standard deviation of 10 points. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.|Baseline to 1 month|||units on a scale||Standard Deviation|Mean
657475|NCT01921829|Secondary|Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Score Change at 1 Month|The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a well-validated 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. An overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. A mean difference over time of 5 points on the KCCQ Overall Summary Scale reflects a clinically significant change in heart failure status. A 10 point decline in KCCQ scores has important prognostic significance in terms of survival.|Baseline to 1 month|||units on a scale||Standard Deviation|Mean
657476|NCT01921829|Secondary|Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Score Change at 1 Month|The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a well-validated 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. An overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. A mean difference over time of 5 points on the KCCQ Overall Summary Scale reflects a clinically significant change in heart failure status. A 10 point decline in KCCQ scores has important prognostic significance in terms of survival.|Baseline to 1 month|||units on a scale||Standard Deviation|Mean
657477|NCT01921829|Secondary|Acute Kidney Injury|Acute kidney injury will be defined based a rise in Cr ≥0.3 mg/dL.|Daily while in hospital, 1 mo & 3 mos|||Participants|||Count of Participants
657478|NCT01921829|Secondary|Fluid Balance|Strict intake (oral intake, intravenous medications, fluids, etc.) and output (urine, emesis, stools, drains, etc.) will be documented by the nurses on the HF floors per routine clinical protocol for all patients. Fluid balance will be determined by subtracting the volume of total intake from the volume of total output (in mL) over 24 hours (7 am to 7 am or the preceding 24-h period if no 7 am to 7 am period is available). Fluid balance and urine output will be ascertained by chart review daily during the intervention while the participants are hospitalized.|Daily while in hospital|||mL/day||Standard Deviation|Mean
657479|NCT01921829|Secondary|Difference From Baseline to 1 Month in Change in Right Internal Jugular Vein (RIJV) Cross-sectional Area (CSA) Pre- and Post-Valsalva|The change in cross-sectional area (CSA) of the right internal jugular vein (RIJV) pre- and post-Valsalva is a measurement of venous compliance and was determined noninvasively with Doppler ultrasound. An increase in RIJV CSA >17% during Valsalva effectively rules out elevated right atrial pressure (RAP) and suggests effective volume removal or decongestion. The difference between baseline and 1 month values of change in RIJV CSA are reported.|Up to 1 month (measured at baseline and 1 mo)|||cm^2||Standard Deviation|Mean
657480|NCT01921829|Secondary|All-cause Mortality|All-cause mortality will be ascertained based on chart review of vital status (alive/dead) and cause of death.|Up to 3 months (assessed at 1 month and 3 months)|||Participants|||Count of Participants
657481|NCT01921829|Secondary|Number of Total Rehospitalizations|Number of rehospitalizations will be ascertained based on chart review of admissions to any hospital after the index hospitalization|Up to 3 months (assessed at 1 month and 3 months)|||hospitalizations||Standard Deviation|Mean
657482|NCT01921829|Secondary|Number of Rehospitalizations for Heart Failure (HF)|Number of rehospitalizations for HF will be ascertained based on chart review of admissions with HF as a coded diagnosis, evidence of clinical volume overload, and treatment with intravenous diuretics.|Up to 3 months (assessed at 1 month and 3 months)|||hospitalizations|||Number
657484|NCT01921829|Primary|Change in Body Weight (kg) From Randomization to Day 4 or Date of Discharge (Whichever Comes First)|The change in body weight (kg) from randomization to day 4 or date of discharge will be determined by the difference between body weight at day 4 after randomization or date of discharge (whichever comes first) and body weight taken at baseline measured in the hospital on standard scales without shoes and wearing a hospital gown, measured before breakfast and post-voiding.|4 days (96 hours)|One patient from ProDiuS arm withdrew before undergoing any randomized treatment.||kg||Standard Deviation|Mean
657485|NCT01921452|Primary|Concentration of TSH in Whole Blood||Day 1 up to Day 5|The FAS included all enrolled participants.||Milli international units per liter||Standard Deviation|Mean
657486|NCT01921452|Primary|Number of Participants With Positive and Negative TSH Test Result||Day 1 up to Day 5|The FAS included all enrolled participants. ‘n’ signifies number of participants who were evaluable for this measure for the specified category.||Participants|||Number
657487|NCT01921348|Other Pre-specified|Immune Biomarkers|Changes in Regulatory T(Treg), Type 1 Regulatory T (Tr1), T helper 3(TH3), T helper 1(TH1), T helper 2(TH2)cells, salivary cortisol, alpha amylase, Interferon gamma(IFNg), Interleukin 4(IL4) and Interleukin 10(IL10) cytokine production from baseline to 8 weeks.|8 weeks|Blood samples were collected and frozen for batch analysis, but not analyzed for data since recruitment goals were not met.|||||
657488|NCT01921348|Secondary|Psychological Measures|Effects of ear acupressure on immune biomarkers based upon psychological differences including perceived stress, anxiety, depression and worry.|8 weeks|Since the immune biomarker frozen blood samples were not analyzed (due to not meeting recruitment goals), the effects of ear accupressure based upon psychological differences could not be analyzed.|||||
657489|NCT01921348|Primary|Rhinoconjunctivitis Quality of Life Questionnaire (Nasal Symptoms Domain Only)|"RQLQ is an instrument that has 28 items in 7 domains (sleep, non-rhinoconjuctivitis symptoms, practical problems, nasal symptoms, eye symptoms activity limitations and emotional function). Participants are asked to recall impairments experienced during the previous week and to respond to each item on a 7-point scale (0=no impairment; 6=maximum impairment).
In this protocol, we used the nasal symptoms domain only; 4 questions, total scale ranges from 0 minimum to 24 maximum.
Longitudinal changes of nasal symptoms domain total were reported from baseline to 8 weeks."|8 weeks|Enrollment targets were not met for both arms/groups.||units on a scale||Standard Deviation|Mean
657490|NCT01921322|Secondary|Glycemic Variability|Glycemic variability (mean amplitude glycemic excursion) using CGM as reference method|Up to 14 days in hospital|subjects incluced in final analysis||mmol/L||Standard Deviation|Mean
657491|NCT01921322|Primary|Time to Target|length of time to achieve target glucose range using Self-Monitoring Blood Glucose (SMBG), as reference method, with the 722 Paradigm Real-Time insulin pump versus Multiple Daily Injection|Up to 14 days in hospital|subjects included in final analysis||days||Standard Deviation|Mean
657492|NCT01921296|Other Pre-specified|Percentage of Patients That Experience Adverse Events|Persistence with cyclobenzaprine therapy for 24 weeks will be assessed using a medication diary. Safety will be assessed using CTCAE criteria|24 weeks|||percentage of participants|||Number
657493|NCT01921296|Other Pre-specified|Percentage of Subjects Who Continue to Take Aromatase Inhibitor Therapy|We will assess the number of patients who continue to take the original aromatase inhibitor medication at the 24 week timepoint, as assessed using patient self-report and medical records|24 weeks|||percentage of participants|||Number
657494|NCT01921296|Secondary|Change in Average Pain Between Baseline and Week 8 With Cyclobenzaprine Therapy|Will measure average pain using the Brief Pain Inventory at baseline and after 8 weeks of therapy with cyclobenzaprine. On the Brief Pain Inventory, average pain is reported using a 0-10 scale, with higher numbers reflecting more pain. Change is calculated by subtracting pain at baseline is from pain at 8 weeks. A positive value represents an increase in pain.|baseline and 8 weeks|Only one of the two enrolled participants completed questionnaires after the baseline assessment||change in average pain||Full Range|Mean
657495|NCT01921296|Secondary|Change in Fatigue Between Baseline and Week 8 With Cyclobenzaprine Therapy|Will measure fatigue using the PROMIS fatigue questionnaire at baseline and after 8 weeks of therapy with cyclobenzaprine. The PROMIS Fatigue 7a score was calculated according to the information provided on the website. The raw score ranges from 7-35. The raw score is then converted to a T score according to the instruction on the website, with higher scores representing more fatigue. The T score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. The change in fatigue is calculated by subtracting the T score at baseline from the T score at 8 weeks. Positive values represent worsening of fatigue.|baseline and 8 weeks|Only one of the two enrolled participants completed questionnaires after the baseline assessment||change in T score||Full Range|Mean
657496|NCT01921296|Primary|Number of Patients That Experience an Improvement in Sleep Quality as Assessed Using the Pittsburgh Sleep Quality Index (PSQI) With 8 Weeks of Cyclobenzaprine Therapy.|Will measure sleep quality using the Pittsburgh Sleep Quality Index at baseline and after 8 weeks of therapy with cyclobenzaprine. A total score is calculated for the Pittsburgh Sleep Quality Index. The total score ranges from 0-21, with higher scores representing worse sleep quality. Any reduction in PSQI total score was considered an improvement.|8 weeks|Only one of the two enrolled participants completed questionnaires after the baseline assessment||participant|||Number
657497|NCT01921101|Other Pre-specified|Immune Parameters|Markers of immune response (including IL-6, IL-10, adiponectin, leptin, CRP, TNF, CD4/CD8 and HLA/CD14|baseline and weekly while hospitalized||||||
657498|NCT01921101|Secondary|Death|The date of death for all participants that die between enrollment and their final data collection, 24 weeks following hospital discharge|date of occurence|||participants|||Number
657499|NCT01921101|Secondary|Days on Mechanical Ventilation|the total number of days requiring mechanical ventilation while hospitalized|days||||||
657500|NCT01921101|Secondary|Length of Hospital Stay|The total number of days the patient is in the hospital|days in hospital||||||
657501|NCT01921101|Primary|Infection|All new infections that occurred (including blood, wound, sputum, urinary tract and pulmonary) from enrollment through hospital discharge recorded in the medical record were counted|Assessed daily from study enrollment through hospital discharge, an average of 3 weeks|||participants|||Number
657577|NCT01919801|Secondary|Number of Participants Admitted to Hospital or Intensive Care Unit (ICU)|Number of participants with and without an occurrence of admission to the hospital (inpatient) or ICU post-treatment due to the ACE-I-induced angioedema attack were described.|Day 0 up to Day 5|mITT population.||participants|||Number
657502|NCT01920958|Secondary|Percentage of Participants With Post-Operative Complications and Adverse Events|An Adverse Event (AE) is defined as any untoward medical occurrence in a participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|Up to 50 Days|ITT population consisted of all patients who received patient information and consented to the collection, transmission and evaluation of their data and who underwent lymph node resection with TachoSil®.||percentage of participants|||Number
657503|NCT01920958|Secondary|Percentage of Participants With Pharmacoeconomic Benefit Based on Drainage Volume Reduced|Pharmacoeconomic benefit was assessed by the surgeon at hospital discharge based on the drainage volume reduced in milliliters.|Up to 50 Days|ITT population consisted of all patients who received patient information and consented to the collection, transmission and evaluation of their data and who underwent lymph node resection with TachoSil®.||percentage of participants|||Number
657504|NCT01920958|Secondary|Percentage of Participants With Pharmacoeconomic Benefit Based on Drainage Time Reduced|Pharmacoeconomic evaluation as assessed by the surgeon at hospital discharge based on drainage time reduced in days.|Up to 50 Days|ITT population consisted of all patients who received patient information and consented to the collection, transmission and evaluation of their data and who underwent lymph node resection with TachoSil®.||percentage of participants|||Number
657505|NCT01920958|Secondary|Percentage of Participants With Pharmacoeconomic Benefit in Shortening of Time Spent in ICU|Pharmacoeconomic benefit was assessed by the surgeon at hospital discharge based on shortening of time spent in ICU in days.|Up to 50 Days|ITT population consisted of all patients who received patient information and consented to the collection, transmission and evaluation of their data and who underwent lymph node resection with TachoSil®.||percentage of participants|||Number
657506|NCT01920958|Secondary|Percentage of Participants With Pharmacoeconomic Benefit Based on Shortening of Hospital Stay|Pharmacoeconomic benefit was assessed by the surgeon at hospital discharge based on shortening of hospital stay in days.|Up to 50 Days|ITT population consisted of all patients who received patient information and consented to the collection, transmission and evaluation of their data and who underwent lymph node resection with TachoSil®.||percentage of participants|||Number
657507|NCT01920958|Secondary|Percentage of Participants With Pharmacoeconomic Benefit Based on Savings of Operating Time|Pharmacoeconomic benefit was assessed by the surgeon based on savings/shortening of operating time in minutes.|Peri- and post-surgery (Up to 50 Days)|ITT population consisted of all patients who received patient information and consented to the collection, transmission and evaluation of their data and who underwent lymph node resection with TachoSil®.||percentage of participants|||Number
657508|NCT01920958|Secondary|Length of Hospital and ICU Stay|Length of stay includes time (days) spent in the intensive care unit (ICU) and normal hospital station.|Up to 50 Days|Participants from the Intent-to-treat population (all participants who received patient information, signed consent and had Tachosil® applied during lymph node surgery) with data available for analysis.||days||Standard Deviation|Mean
657509|NCT01920958|Secondary|Percentage of Participants With Change in Length of Drainage Stay and Drainage Volume||Up to 50 Days|Participants from the Intent-to-treat population (all participants who received patient information, signed consent and had Tachosil® applied during lymph node surgery) with data available for analysis.||percentage of participants|||Number
657510|NCT01920958|Secondary|Percentage of Participants With at Least One Drainage Inserted|The total number of participants where at least one drainage was used during the operation.|Baseline (Day of Surgery)|Participants from the Intent-to-treat population (all participants who received patient information, signed consent and had Tachosil® applied during lymph node surgery) with data available for analysis.||percentage of participants|||Number
657511|NCT01920958|Secondary|Assessment of TachoSil® by the Surgeon With Respect to Satisfaction Using a 10-Point Numerical Rating Scale|The surgeon evaluated Satisfaction in Operation of TachoSil® using a 10-point scale where: 1=very satisfied to 10=totally unsatisfied.|Peri- and post-surgery (Up to 50 Days)|Participants from the Intent-to-treat population (all participants who received patient information, signed consent and had Tachosil® applied during lymph node surgery) with data available for analysis.||score on a scale||Standard Deviation|Mean
657512|NCT01920958|Secondary|Assessment of TachoSil® by the Surgeon With Respect to Utility in Operation Using a 10-Point Numerical Rating Scale|The surgeon evaluated Utility in Operation of TachoSil® using a 10-point scale where: 1=very useful to 10=completely useless.|Peri- and post-surgery (Up to 50 Days)|Participants from the Intent-to-treat population (all participants who received patient information, signed consent and had Tachosil® applied during lymph node surgery) with data available for analysis.||score on a scale||Standard Deviation|Mean
657513|NCT01920958|Secondary|Assessment of TachoSil® by the Surgeon With Respect to Handling Using a 10-Point Numerical Rating Scale|The surgeon evaluated handling of TachoSil® using a 10-point scale where: 1=very good to 10=very poor.|Peri- and post-surgery (Up to 50 Days)|Participants from the Intent-to-treat population (all participants who received patient information, signed consent and had Tachosil® applied during lymph node surgery) with data available for analysis.||score on a scale||Standard Deviation|Mean
657514|NCT01920958|Primary|Percentage of Participants With Post-Operative Seroma Formation Over Time as Determined at Hospital Discharge||Up to 50 Days|Intent-to-treat population consisted of all participants who received patient information, signed consent and had Tachosil® applied during lymph node surgery.||percentage of participants|||Number
657515|NCT01920893|Post-Hoc|Change From Baseline in Nasal Total Symptoms Score (nTSS) at Week 16|nTSS was the sum of participant-assessed nasal symptom scores for nasal congestion/obstruction, decreased/loss of sense of smell, and rhinorrhea (anterior/posterior nasal discharge), each accessed on 0-3 categorical scale. Total score ranges from 0 (no symptoms) to 9 (severe symptoms). Higher score indicated severe symptoms.|Baseline, Week 16|Participants from ITT population with nTSS data available at Week 16.||score on a scale||Standard Deviation|Mean
657578|NCT01919801|Secondary|Number of Participants Experienced Airway Intervention Due to ACE-I-induced Angioedema|Airway Intervention included intubation, tracheotomy, cricothyrotomy.|Day 0 up to Day 5|Modified Intent to treat (mITT) population included all randomized participants who received the study drug.||participants|||Number
657516|NCT01920893|Secondary|Change From Baseline in 22-Item Sinonasal Outcome Test (SNOT-22) at Week 16|The SNOT-22 was a validated questionnaire to assess the impact of chronic rhinosinusitis on quality of life. The total score may range from 0 (no problem)-110 (worst quality of life), higher scores represented worst quality of life; minimal clinically important change ≥ 8.90.|Baseline, Week 16|Participants from ITT population with SNOT-22 data available at Week 16.||score on a scale||Standard Deviation|Mean
657517|NCT01920893|Secondary|Time to First Response in NPS: Kaplan-Meier Estimate at Week 16|The time-to-first response in NPS: time from the date of randomization to the date of first NPS (defined as >=1 point reduction from baseline score); for participants without NPS >=1 point reduction, it was censored at the end of treatment date. The median time to first response was not estimated because the number of responses was too low in the Dupilumab arm. Therefore, alternative Kaplan-Meier statistics, the probability of response at Week 16, are presented as the descriptive measure statistics.|Baseline to Week 16|ITT population.||Probability of response||95% Confidence Interval|Number
657518|NCT01920893|Secondary|Change From Baseline in Sinus Computed Tomography (CT) Scan Assessments at Week 16: Percent Area Occupied by Disease|CT scan assessment included Lund-Mackay score and percentage of the area of maxillary sinuses occupied by disease.|Baseline, Week 16|Participants from ITT population with CT scan data available at Week 16.||percent area||Standard Deviation|Mean
657519|NCT01920893|Secondary|Change From Baseline in Sinus Computed Tomography (CT) Scan Assessments at Week 16: Lund-Mackay Score|CT scan assessment included Lund-Mackay score and percent of the maxillary sinuses occupied by disease. The Lund-Mackay scoring system rated each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses. The total score ranges from 0 (normal) - 24 (more opacified); higher score indicated worse status.|Baseline, Week 16|Participants from ITT population with CT scan data available at Week 16.||score on scale||Standard Deviation|Mean
657520|NCT01920893|Secondary|Change From Baseline in Smell Test (University of Pennsylvania Smell Identification Test [UPSIT]) Scores at Week 16|UPSIT was a 40-item test to measure the individual's ability to detect odors. Total score ranges from 0 (anosmia)-40 (normal sense of smell), lower score indicated severe smell loss.|Baseline, Week 16|Participants from ITT population with data available for UPSIT at Week 16.||score on scale||Standard Deviation|Mean
657521|NCT01920893|Secondary|Change From Baseline in Nasal Peak Inspiratory Flow (NPIF) at Week 16|NPIF evaluation represents a physiologic measure of the air flow through both nasal cavities during forced inspiration and/or expiration expressed in liter per minute.|Baseline, Week 16|Participants from ITT population with data available for NPIF at Week 16.||liter/minute||Standard Deviation|Mean
657522|NCT01920893|Secondary|Change From Baseline in Visual Analogue Scale (VAS) for Rhinosinusitis Symptoms Severity at Week 16|Severity of rhinosinusitis symptoms were assessed on a 0 cm (not troublesome) - 10 cm (worst thinkable troublesome) VAS where higher score indicated worst thinkable troublesome.|Baseline, Week 16|Participants from ITT population with data available for Rhinosinusitis Symptoms Severity VAS at Week 16.||centimetre (cm)||Standard Deviation|Mean
657523|NCT01920893|Secondary|Change From Baseline in Participant Reported Symptoms Scores of Sinusitis at Week 16|Morning symptoms of sinusitis (nasal congestion/obstruction, anterior rhinorrhea [runny nose], posterior rhinorrhea [post nasal drip], and loss of sense of smell) were assessed using a 0 (no symptoms) - 3 (severe symptoms) categorical scale where higher score indicated severe symptoms.|Baseline, Week 16|Participants from ITT population with data available for symptom score at Week 16.||score on a scale||Standard Deviation|Mean
657524|NCT01920893|Secondary|Change From Baseline in Bilateral Endoscopic NPS at Week 16 in Participants With Asthma|NPS was the sum of the right and left nostril scores, as evaluated by means of nasal endoscopy. Total score ranges from 0 to 8 (scored 0 [no polyp] to 4 [large polyps] for each nostril), with a lower score indicating smaller-sized polyps.|Baseline, Week 16|Participants of the ITT population with asthma and with available data at Week 16.||score on a scale||Standard Deviation|Mean
657525|NCT01920893|Primary|Change From Baseline in Bilateral Endoscopic Nasal Polyp Score (NPS) at Week 16|NPS was the sum of the right and left nostril scores, as evaluated by means of nasal endoscopy. Total score ranges from 0 to 8 (scored 0 [no polyp] to 4 [large polyps] for each nostril), with a lower score indicating smaller-sized polyps.|Baseline, Week 16|Intent-to-treat (ITT) population included all randomized participants analyzed according to the treatment group allocated by randomization. Here, number analyzed = number of participants with available data for specified time points.||score on a scale||Standard Deviation|Mean
657526|NCT01920854|Primary|Baseline Transferrin Profile: Cohorts 1, 2, 3, 4, 5, 6|The mean baseline transferrin will be calculated based on samples drawn just prior to infusion for all Cohorts (both SFP and placebo)|Baseline (1 day)|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.||mg/dL||Standard Deviation|Mean
657527|NCT01920854|Secondary|Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Vz)|"Samples for volume of distribution in the terminal elimination phase (Vz) calculations were collected for all Cohorts (just those subjects that received SFP).
There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.||dL||Standard Deviation|Mean
657528|NCT01920854|Secondary|Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Half Life: t 1/2)|"Samples for terminal phase half life (t 1/2) calculations were collected for all Cohorts (just those subjects that received SFP).
There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.||hours||Standard Deviation|Mean
657529|NCT01920854|Secondary|Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Lambda z)|"Samples for terminal phase rate constant (lambda z) calculations were collected for all Cohorts (just those subjects that received SFP).
There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.||1/hour||Standard Deviation|Mean
657530|NCT01920854|Secondary|Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Cmax/Dose)|"Samples for the dose-normalized maximal baseline corrected concentration of iron (Cmax/dose) calculations were collected for all Cohorts (just those subjects that received SFP).
There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.||micrograms/dL/mg||Standard Deviation|Mean
657531|NCT01920854|Secondary|Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Tmax)|"Samples for observed time to reach maximum iron concentration (Tmax) calculations were collected for all Cohorts (both SFP and placebo).
There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.||hours||Full Range|Median
657532|NCT01920854|Secondary|Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (C Max)|"Samples maximal baseline corrected concentration of iron (Cmax) calculations were collected for all Cohorts (both SFP and placebo).
There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.||microgram/dL||Standard Deviation|Mean
657533|NCT01920854|Secondary|Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean CL [Clearance])|"Samples for Clearance (CL) calculations were collected for all Cohorts (just those subjects that received SFP).
There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.||dL/hour||Standard Deviation|Mean
657534|NCT01920854|Secondary|Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean AUC [Area Under the Curve] Inf)|"Samples for area under the curve from time-zero extrapolated to infinity (AUC inf) calculations were collected for all Cohorts (just those subjects that received SFP).
There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.||h*microgram/dL||Standard Deviation|Mean
657535|NCT01920854|Secondary|Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean AUC [Area Under the Curve] 0 - 12, Mean AUC 0 - 4, Mean AUC Last)|"Samples for three area under the curve (AUC) calculations (AUC 0-12, AUC 0 - 4, and AUC last) were collected for all Cohorts (both SFP and placebo).
There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.||h*microgram/dL||Standard Deviation|Mean
657536|NCT01920854|Primary|Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected)|"Samples for unbound iron binding capacity for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for unbound iron binding capacity for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.
There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.||micrograms/dL||Standard Deviation|Mean
657537|NCT01920854|Primary|Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected)|"Samples for unbound iron binding capacity for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for unbound iron binding capacity for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.
There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.||micrograms/dL||Standard Deviation|Mean
657538|NCT01920854|Primary|Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected)|"Samples for non-transferrin bound iron for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for non-transferrin bound iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.
There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.||micrograms/dL||Standard Deviation|Mean
657539|NCT01920854|Primary|Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected)|"Samples for non-transferrin bound iron for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for non-transferrin bound iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.
There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.||micrograms/dL||Standard Deviation|Mean
657540|NCT01920854|Primary|Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute)|"Samples for total iron binding capacity for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for total iron binding capacity for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.
There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.||micrograms/dL||Standard Deviation|Mean
657541|NCT01920854|Primary|Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute)|"Samples for total iron binding capacity for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for total iron binding capacity for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.
There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.||micrograms/dL||Standard Deviation|Mean
657542|NCT01920854|Secondary|Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated)|"Samples for transferrin saturation for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for transferrin saturation for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.
There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.||percentage of saturation||Standard Deviation|Mean
657556|NCT01920568|Secondary|Serum Concentration of Denosumab on Day 1, at Week 2, Week 5, Week 9, Week 13, Week 17, Week 19, Week 21, Week 25 and Week 49|Blood samples were drawn on study Day 1, pre-dose; 4 hours, 24 hours, and at Week 2 (168 hours); then pre-dose at Week 5, Week 9, Week 13, Week 17, Week 19 (no dose), Week 21, Week 25, and Week 49.|Samples were collected at pre-dose (Day 1); 4 hours, 24 hours, 168 hours post-dose; pre-dose at Week 5, Week 9, Week 13, Week 17; Week 19 (at 336 hours); pre-dose at Week 21, Week 25, Week 49|Pharmacokinetic (PK) Population: comprised of participants who signed informed consent to participate in the PK sub-study and who had their PK parameters evaluable according to GSK standards. Only those participants with evaluable parameters are included (represented by n=X in the category titles).||micrograms per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
657543|NCT01920854|Secondary|Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated)|"Samples for transferrin saturation for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for transferrin saturation for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.
There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.||percentage of saturation||Standard Deviation|Mean
657544|NCT01920854|Primary|Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected)|"Samples for transferrin-bound iron for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for transferrin-bound iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.
There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.||micrograms/dL||Standard Deviation|Mean
657545|NCT01920854|Primary|Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected)|"Samples for transferrin-bound iron for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for transferrin-bound iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.
There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.||micrograms/dL||Standard Deviation|Mean
657546|NCT01920854|Primary|Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected)|"Serum iron for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Serum iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.
There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.||micrograms/dL||Standard Deviation|Mean
657547|NCT01920854|Primary|Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected)|"Serum iron for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Serum iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.
There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.||micrograms/dL||Standard Deviation|Mean
657548|NCT01920802|Other Pre-specified|Change in Lipid Metabolism|Change in lipid metabolism as measured by cholesterol/HDL ratio|Baseline to Day 28|||ratio||Standard Deviation|Mean
657549|NCT01920802|Other Pre-specified|Change in Food Intake|Total grams of food consumed|Baseline to Day 28|||grams||Standard Deviation|Mean
657550|NCT01920802|Other Pre-specified|Insulin Resistance|Homeostatic model assessment for Insulin Resistance (HOMA-IR) is a method for assessing β-cell function and insulin resistance (IR) from basal (fasting) glucose and insulin.|Baseline to Day 28|||HOMA-IR score||Standard Deviation|Mean
657551|NCT01920802|Other Pre-specified|Change in Insulin|Change in Insulin levels from baseline to Day 28|Baseline to Day 28|||mlU/L||Standard Deviation|Mean
657552|NCT01920802|Other Pre-specified|Change Glucose in People Taking Olanzapine or Iloperidone|To quantify, prospectively, change in glucose from baseline to Day 28|Baseline to study termination (about 12 weeks)|||mg/dL||Standard Deviation|Mean
657553|NCT01920802|Secondary|Change in Leptin|Leptin levels measured at Day 3 compared to baseline|change in baseline to Day 3|||ng/dL||Standard Deviation|Mean
657554|NCT01920802|Primary|Change in Adiposity|Total fat mass (excluding head) from baseline to Day 28|Baseline to Day 28|||grams||Standard Deviation|Mean
657555|NCT01920802|Primary|Change in Body Weight|Delineate a pathophysiological mechanism of antipsychotic induced weight gain|baseline and 6 week visit|||kg||Standard Deviation|Mean
657557|NCT01920568|Secondary|Number of Participants With Confirmed Anti-denosumab Antibody Formation at Day 1, Week 25 and Week 53.|Anti-denosumab antibody formation was assessed at Day 1, Week 25 and Week 53. Binding antibody assay was used to assess number of participants with anti-denosumab antibody.|Day 1, Week 25 and Week 53|FAS-Safety Population. Only those participants on whom anti-denosumab antibody formation was analyzed at specified time point is presented (represented by n=X, X in the category titles).||Participants|||Number
657558|NCT01920568|Secondary|Number of Participants With Worst-case On-therapy Increase in the Indicated Hematology Parameters From Baseline Grade to the Indicated Grade.|Hematology parameters included hemoglobin, lymphocytes, platelet count, total neutrophils, white blood cell (WBC) count. All reported values are of participants with worst-case on-therapy increase to the specified grade: Any increase, that is, worst-case increase to grade 1, 2, 3, or 4 (any grade); worst-case increase to grade 3 (WC G3); and worst-case increase to grade 4 (WC G4). Participants with missing Baseline grade were assumed to have a Baseline grade of 0. The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments.|Baseline and up to last study-related visit (up to 53 weeks)|FAS-Safety Population. Only participants whose indicated on-therapy lab values were available (represented by n=X, X in the category titles) were analyzed.||Participants|||Number
657559|NCT01920568|Secondary|Number of Participants With Worst-case (WC) On-therapy Increase in the Indicated Clinical Chemistry Parameters From Baseline Grade to the Indicated Grade.|Clinical chemistry parameters were measured at the Screening and Weeks 2, 5, 9, 13, 25, 37, and 53 visits. Clinical chemistry parameters measured on-study included albumin, alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, calcium (Ca), creatinine, magnesium, and phosphorous (P) inorganic. All reported values are of participants with worst-case on-therapy increase to the specified grade: Any increase, that is, worst-case increase to grade 1, 2, 3, or 4 (any grade); worst-case increase to grade 3 (WC G3); and worst-case increase to grade 4 (WC G4). The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) was used for grading. Participants with missing Baseline grade were assumed to have a Baseline grade of 0. The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments.|Baseline and up to last study-related visit (up to 53 weeks)|FAS-Safety Population. Only participants whose indicated on-therapy laboratory values were available (represented by n=X, X in the category title) were analyzed.||Participants|||Number
657560|NCT01920568|Secondary|Number of Participants With Any Adverse Events (AEs), Serious Adverse Events (Non-fatal Serious Adverse Events and Fatal Serious Adverse Events)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or other events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcome listed above, liver injury and impaired liver function and grade 4 laboratory abnormalities. Number of participants with any AEs, non-fatal SAEs, fatal SAEs have been presented.|From start of IP through the Study Phase (49 weeks post-dose) (assessed up to 73 weeks)|Full-Analysis-Set Safety (FAS-Safety) Population: comprised of all randomized participants who received at least one dose of study treatment and was based on the actual study treatment received (if this differed from that to which the participant was randomized).||Participants|||Number
657561|NCT01920568|Secondary|Percent Change From Baseline in the Serum Bone-specific Alkaline Phosphatase (s-BALP) at Week 13.|Baseline value is the most recent, non-missing value prior to or on the first study treatment dose date. Change from Baseline is the value at Indicated visit minus Baseline value. Percent change from Baseline is the change from Baseline divided by Baseline value multiplied by 100.|Baseline and Week 13|FAS-ITT Population. All participants who were randomized and had a observed values at Baseline and Week 13 were used in the analysis.||Percent change||Full Range|Median
657562|NCT01920568|Secondary|Percentage Change From Baseline to Week 13 in Urinary Amino-terminal Cross-linking Telopeptide of Type I Collagen of Type I Collagen Corrected for Urine Creatinine (uNTx/uCr) in Participants With Advanced Breast Cancer.|uNTx/uCr is the bone turnover marker correlated with the presence and extent of metastases, and the prognosis and response to bone targeted treatment. uNTx/uCr was expressed in nanomoles bone collagen equivalent per millimole (nM BCE/mM). Secondary objective: to compare the effect of denosumab with that of zoledronic acid on % chg from BL in uNTx/uCr at Wk 13 in breast cancer par. with bone metastases from solid tumors. Baseline value is the most recent, non-missing value prior to or on the first study treatment dose date. Change from Baseline is the value at Week 13 minus Baseline value. Percent chg from BL is the chg from BL / BL value * 100. For missing Wk 13 observations, the last post-BL value was carried forward to obtain the Wk 13 value.|Baseline and Week 13|FAS-ITT Population. Participants with advanced breast cancer.||Percent change||95% Confidence Interval|Least Squares Mean
657563|NCT01920568|Secondary|Percentage Change From Baseline to Week 13 in Urinary Amino-terminal Cross-linking Telopeptide of Type I Collagen of Type I Collagen Corrected for Urine Creatinine (uNTx/uCr) in Chinese Participants.|uNTx/uCr is the bone turnover marker correlated with the presence and extent of metastases, and the prognosis and response to bone targeted treatment. uNTx/uCr was expressed in nanomoles bone collagen equivalent per millimole (nM BCE/mM). Secondary objective: to compare the effect of denosumab with that of zoledronic acid on % chg from BL in uNTx/uCr at Wk 13 in par. of Chinese ancestry with bone metastases from solid tumors. Baseline value is the most recent, non-missing value prior to or on the first study treatment dose date. Change from Baseline is the value at Week 13 minus Baseline value. Percent chg from BL is the chg from BL / BL value * 100. For missing Wk 13 observations, the last post-BL value was carried forward to obtain the Wk 13 value.|Baseline and Week 13|FAS-ITT Population. Chinese participants.||Percent change||95% Confidence Interval|Least Squares Mean
657564|NCT01920568|Primary|Percent Change (Chg) From Baseline (BL) to Week (Wk)13 in Urinary Amino-terminal Cross-linking Telopeptide of Type I Collagen Corrected for Urine Creatinine (uNTx/uCr)|uNTx/uCr is the bone turnover marker correlated with the presence and extent of metastases, and the prognosis and response to bone targeted treatment (trt). uNTx/uCr was expressed in nanomoles bone collagen equivalent per millimole (nM BCE/mM). Primary objective: to compare the effect of denosumab with that of zoledronic acid on % chg from BL in uNTx/uCr at Wk 13 in par. of Asian ancestry with bone metastases from solid tumors. BL value is the most recent, non-missing value prior to or on the 1st study trt dose date. Chg from BL is the value at Wk13 minus BL value. Percent chg from BL is the chg from BL / BL value * 100. For missing Wk 13 observations, the last post-BL value was carried forward to obtain the Wk 13 value.|Baseline (BL) and Week (Wk) 13|Full-Analysis-Set Intent-to-Treat (FAS-ITT) Population: comprised of all randomized participants regardless of whether or not study treatment was administered. Only those participants with values at Baseline and Week 13 were included in the analysis.||Percent change||95% Confidence Interval|Least Squares Mean
657567|NCT01920282|Primary|Beta-stiffness Index|Longitudinal B-mode images of the left common carotid artery diameter (1-2 cm proximal to the carotid bulb) were obtained over 15 consecutive cardiac cycles. Brachial blood pressure was measured via an automated sphygmomanometer. Quantification of systolic and diastolic carotid artery diameters were analyzed with the Vascular Research Tools 5 software program. Beta-stiffness index was calculated as: Beta = ln(P1/P0)/((D1-D0)/D0), where D0 represents the minimal diameter recorded during diastole, D1 represents the maximal diameter recorded during systole, P0 represents the pressure measured during diastole, and P1 represents the pressure measured during systole.|12 weeks|||Arbitrary units||Standard Error|Mean
657568|NCT01920178|Other Pre-specified|Number of Participants With Adverse Events During and Following Each Study Treatment||12 months|||participants|||Number
657569|NCT01920178|Secondary|Measure Clinical Improvement as Judged by the Patient and Determine Presence of Onychomycosis by PCR Analysis of Nail Samples||12 months|PCR lab analysis of nail samples obtained for each subject was not performed with the original study sponsor Nuvolase, Inc/ PinPointe withdrawing support for such analysis during the study.|||||
657570|NCT01920178|Primary|Measure Improvement in Target Toenails During the Study Period by Deeming a Clinical Success if Patient Experiences at Least a 50% Reduction in the Area of Involved Nail, Judged by the Clinician, and Judged by an Independent Evaluator.||12 months|Original grooved markings scored into the Target nails (hallux nails) on initial laser treatment visit to indicate most proximal aspect of fungal infection was intended to track the growth of the nail and to evaluate for improvement. Grooved markings did not survive after initial visit making it impossible to obtain valid primary endpoint data.|||||
657571|NCT01919996|Secondary|Occurrence of a Clinically Significant Change (Improvement or Worsening) Based on Five Ophthalmic Examinations|Clinically significant change (improvement or worsening) is based on five ophthalmic exams at baseline and the final visit. Any 1 or more of these conditions are a clinically significant change: 1) A worsening in BCVA (distance), as defined in outcome measure 1 OR an improvement in BCVA (distance) as defined in outcome measure 2. 2) A worsening in color vision (FM-100), as defined in outcome measure 1 OR an improvement in color vision (FM-100) as defined in outcome measure 2. 3) A worsening in Amsler Grid, as defined in outcome measure 1, OR an improvement in Amsler Grid, as defined in outcome measure 2. 4) A worsening in anterior segment biomicroscopy, as defined in outcome measure 1 OR an improvement in anterior segment biomicroscopy as defined in outcome measure 2. 5) A worsening in dilated indirect ophthalmoscopy, as defined in outcome measure 1 OR an improvement in dilated indirect ophthalmoscopy as defined in outcome measure 2.|14 days|The safety population included all enrolled participants that took at least one dose of study medication. One participant was not evaluable because visual acuity was not corrected at Baseline (Day 1) and was corrected at Final Visit (Day 14).||percentage of participants|||Number
657572|NCT01919996|Secondary|Occurrence of a Clinically Significant Improvement Based on Five Ophthalmic Examinations|1 or more of these conditions are clinically significant improvement based on five ophthalmic exams:1) clinically significant improvement in BCVA(distance) at the final visit, in either eye, defined as an increase in score of 5 or more letters from baseline in ETDRS BCVA.2) Assessment of abnormal clinically significant at baseline and normal or abnormal, non-clinically significant at final visit in color vision(FM-100) in either eye. 3) Assessment of abnormal clinically significant at baseline and normal/abnormal, non-clinically significant at final visit in Amsler Grid in either eye. 4) Assessments of abnormal clinically significant at baseline and normal/abnormal, non-clinically significant at final visit in anterior segment biomicroscopy, in any of the 10 eye structures in either eye. 5)Assessments of abnormal clinically significant at baseline and normal/abnormal, nonclinically significant at final visit in dilated ophthalmoscopy in any of the 5 eye structures in either eye.|14 days|The safety population included all enrolled participants that took at least one dose of study medication. One participant was not evaluable because visual acuity was not corrected at Baseline (Day 1) and was corrected at Final Visit (Day 14).||percentage of participants|||Number
657573|NCT01919996|Primary|Occurrence of a Clinically Significant Worsening Based on Five Ophthalmic Examinations|Clinically significant worsening is an observed worsening in any of the five ophthalmic exams: 1) Clinically significant worsening in best corrected visual activity (BCVA) (distance) at the final visit, in either eye, is defined as a decrease in score of 5 or more letters from baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA. 2) An assessment of abnormal clinically significant at final visit in color vision Farnsworth Munsell 100 Hue Test (FM-100) in either eye. 3) An assessment of abnormal clinically significant at final visit in Amsler Grid in either eye. 4) Assessments of abnormal clinically significant at final visit in anterior segment biomicroscopy, in any of the 10 eye structures in either eye. 5) Assessments of abnormal clinically significant at final visit in dilated indirect ophthalmoscopy in any of the 5 eye structures in either eye.|14 days|The safety population included all enrolled participants that took at least one dose of study medication. One participant was not evaluable because visual acuity was not corrected at Baseline (Day 1) and was corrected at Final Visit (Day 14).||percentage of participants|||Number
657574|NCT01919801|Other Pre-specified|Area Under the Plasma Concentration Versus Time Curve (AUC) of Icatibant and Its Metabolites (M1 and M2)|Area under the plasma concentration-time curve of Icatibant and its metabolites (M1 and M2) were analyzed. A population pharmacokinetic analysis approach using sparse pharmacokinetic sampling obtained from a subset of subjects was used to evaluate exposure to icatibant.|0.75 and 2 hours post-dose|PK analysis population.||hours*nanogram per milliliter (h*ng/mL)||Standard Deviation|Mean
657575|NCT01919801|Secondary|Percentage of Participants With Time to Meeting Discharge Criteria (TMDC) at Specified Time Points|TMDC was based on the investigator-assessed angioedema-associated upper airway symptom assessments. It was calculated from the time of study drug administration to the earliest time point at which the symptoms of difficulty breathing and difficulty swallowing were absent and the symptoms of voice change and tongue swelling were mild or absent and all subsequent assessments continued to satisfy these conditions. These symptoms were evaluated by the investigator using a 5-point grading scale (0=absent, 1=mild, 2=moderate, 3=severe, and 4=very severe). TMDC was analysed using Kaplan-Meier estimates.|4, 6, and 8 hours post treatment|mITT population.||percentage of participants|||Number
657576|NCT01919801|Secondary|Number of Participants Experienced ACE-I-induced Angioedema Attack Following Study Drug Administration|Number of participants with the use of conventional medications (corticosteroids, antihistamines, epinephrine) for the treatment of symptoms of the ACE-I- induced angioedema attack following study drug administration were presented.|Day 0 up to Day 5|mITT population.||participants|||Number
657579|NCT01919801|Secondary|Time to Onset of Symptom Relief (TOSR)|TOSR was calculated for the individual symptoms with pre-treatment scores of 2 (moderate) or more improved by at least 1 severity grade and the individual symptoms with pretreatment scores of 0 or 1 (absent or mild) were scored again at 0 or 1 and all the subsequent assessments continued to satisfy this condition. Time-to-event data were summarized using Kaplan-Meier estimates.|Day 0 up to Day 5|ITT population.||days||Inter-Quartile Range|Median
657580|NCT01919801|Primary|Number of Participants With Clinically Significant Changes in Laboratory Evaluation, Vital Signs, Electrocardiogram (ECG) and Physical Examination|During laboratory evaluation, serum chemistry and hematology blood tests, and urinalysis were performed. Vital signs parameters included evaluation of pulse rate and systolic and diastolic blood pressure. Standard 12-lead ECGs were performed and ECG recordings were read locally at the study site by a cardiologist. Physical examination was performed with examination of major body systems per routine clinical practice.|Day 0 to Day 5|Safety population.||participants|||Number
657581|NCT01919801|Primary|Number of Participants With Treatment Emergent Injection Site Reaction|Injection site reaction included erythema, swelling, cutaneous pain, burning sensation, itching and warm sensation|Day 0 to Day 5|Safety population.||participants|||Number
657582|NCT01919801|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAE) and Treatment-emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were defined as adverse events/serious adverse events that started or worsened after the study drug treatment.|From start of study drug administration (Day 0) up to follow-up (Day 5)|Safety population included all participants who received the study drug.||participants|||Number
657583|NCT01919801|Primary|Time to Meeting Discharge Criteria (TMDC)|TMDC was based on the investigator-assessed angioedema-associated upper airway symptom assessments. It was calculated from the time of study drug administration to the earliest time point at which the symptoms of difficulty breathing and difficulty swallowing were absent and the symptoms of voice change and tongue swelling were mild or absent and all subsequent assessments continued to satisfy these conditions. These symptoms were evaluated by the investigator using a 5-point grading scale (0=absent, 1=mild, 2=moderate, 3=severe, and 4=very severe). TMDC was analysed using Kaplan-Meier estimates.|Day 0 up to Day 5|Intent-to-treat (ITT) population included all randomized participants.||days||Inter-Quartile Range|Median
657584|NCT01919723|Secondary|Periprocedural Myocardial Infarction (PMI)|Number of subjects that developed PMI. Periprocedural myocardial infarction (PMI) was defined as an increase in troponin I values >5 x 99th percentile the upper limit of normal in patients with normal baseline value on admission, or a rise of troponin I values >20% after PCI if the baseline value was elevated.|Up to 24 hours|2 subjects in each arm did not meet the inclusion criteria (blood hemolyzed) and thus we do not have the primary and secondary outcomes for them.||Number of subjects|||Number
657585|NCT01919723|Secondary|Bleeding Complications|Number of subjects that developed gastrointestinal bleeding after Percutaneous Coronary Intervention (PCI). These subjects were categorized under Bleeding Academic Research Consortium 3b. Type 3b bleeding includes overt bleeding plus a hemoglobin drop of ≥5 g/dL (provided the hemoglobin drop is related to bleeding), cardiac tamponade, bleeding requiring surgical intervention for control (excluding dental/nasal/skin/hemorrhoid), and bleeding requiring intravenous vasoactive drugs.|up to 24 hours|2 subjects in each arm did not meet the inclusion criteria (blood hemolyzed) and thus we do not have the primary and secondary outcomes for them.||Number of subjects|||Number
657586|NCT01919723|Secondary|High On-treatment Platelet Reactivity (HPR)|Percentage of participants with HPR. HPR is defined as platelet aggregation >59% in response to 20 µM ADP.|Comparing baseline and follow-up (2 hours)|2 subjects in each arm did not meet the inclusion criteria (blood hemolyzed) and thus we do not have the primary and secondary outcomes for them.||percentage of participants|||Number
657587|NCT01919723|Primary|Change in Percent Inhibition of Platelet Aggregation (%IPA)|Change from baseline in %IPA at 2 hours after stimulation with 20µM ADP (µM-micromolar, ADP-Adenosine diphosphate), measured in blood by an aggregometer among patients randomized to ticagrelor and 2 boluses of eptifibatide vs. ticagrelor and 2 boluses plus infusion of eptifibatide.|Baseline and 2 hours|2 subjects in each arm did not meet the inclusion criteria (blood hemolyzed) and thus we do not have the primary and secondary outcomes for them.||percentage of IPA||Standard Deviation|Mean
657588|NCT01919606|Secondary|Incidence of Adverse Events||10 days post surgery plus or minus 3 days|||number of events|||Number
657589|NCT01919606|Primary|Duration of Analgesia||End of surgery to time of subject's first postsurgical opioid administration (through 72 hours)||||||
657590|NCT01919450|Primary|Measure Quantitated Myocardial Perfusion Reserve After a 1 Minute Delay in Lexiscan (Regadenoson)|The end-point of this study is to establish the mean and standard deviations of myocardial blood flow reserve values based on a 10 second, 1 minute, 2 minute and 4 minute delays between Lexiscan (Regadenoson) injection and the start of myocardial perfusion PET imaging.|1 minute|||Ratio||Standard Deviation|Mean
657591|NCT01919450|Primary|Measure Quantitated Myocardial Perfusion Reserve After a 10 Second Delay in Lexiscan (Regadenoson)|The end-point of this study is to establish the mean and standard deviations of myocardial blood flow reserve values based on a 10 second, 1 minute, 2 minute and 4 minute delays between Lexiscan (Regadenoson) injection and the start of myocardial perfusion PET imaging.|10 seconds|||Ratio||Standard Deviation|Median
657592|NCT01919450|Primary|Measure Quantitated Myocardial Perfusion Reserve After a 2 Minute Delay in Lexiscan (Regadenoson)|The end-point of this study is to establish the mean and standard deviations of myocardial blood flow reserve values based on a 10 second, 1 minute, 2 minute and 4 minute delays between Lexiscan (Regadenoson) injection and the start of myocardial perfusion PET imaging.|2 mintues|||Ratio||Standard Deviation|Mean
657593|NCT01919450|Primary|Measure Quantitated Myocardial Perfusion Reserve After a 4 Minute Delay in Lexiscan (Regadenoson)|The end-point of this study is to establish the mean and standard deviations of myocardial blood flow reserve values based on a 10 second, 1 minute, 2 minute and 4 minute delays between Lexiscan (Regadenoson) injection and the start of myocardial perfusion PET imaging.|4 minutes|||Ratio||Standard Deviation|Mean
657600|NCT01919229|Secondary|Safety and Tolerability of the Combination|Occurrence, frequency and severity of adverse events (AEs), laboratory abnormalities|Up to 30 days after the last dose|Since the study was terminated, no efficacy data was obtained, but see Adverse Events (AE) section for all AEs collected.||Participants|||Number
657601|NCT01919229|Primary|Cell Cycle Response Rate Per Cell Proliferation Marker Ki67|Cell cycle response rate is defined by proportion of patients with natural logarithm of Ki-67 levels (expressed as percentage of baseline values) of less than 1 at the time of surgery. Since the trial was prematurely terminated, no statistical analysis was done.|Day 1, Day15|Since the study was terminated, no efficacy data was obtained.|||||
657602|NCT01918800|Secondary|Timed 25 Foot Walk (T25-FW)|The time to walk 8 meters or 25 feet is strongly related to its ordinal counterpart the Ambulation Index (Spearman r = 0.91), without the variability that the ordinal scale reflects.T25-FW was used in this study to measure ambulation status and as an additional measure of mobility. The score for the T25-FWis the average of the two completed trials in seconds|4 months|||seconds||Standard Deviation|Mean
657603|NCT01918800|Secondary|Pittsburgh Sleep Quality Index (PSQI)|"The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a l-month time interval. Nineteen individual items generate seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score between 0-21. Higher scores indicate worse sleep quality."|4 months|||units on a scale||Standard Deviation|Mean
657604|NCT01918800|Secondary|Rapid Assessment of Physical Activity (RAPA)|"The self-report, retrospective Rapid Assessment of Physical Activity (RAPA) was developed to provide an easily administered and interpreted means of assessing levels of physical activity among adults older than 50 years. The RAPA is an easy-to-use, valid measure of physical activity for use in clinical practice with older adults. A tool for older adults will be easy to use for people with MS who may not be regular exercisers. Each question has a 'Yes' or 'No' option. The total score of the first seven items is out of 7; participants choose which question corresponds to their activity level. Any score less than 6 is considered suboptimal. From these values we provided a percentage of the number of people exercising optimally in the RAPA Cardiovascular.
Strength training and flexibility are scored separately (strength training = 1, flexibility = 2, both = 3). Based on total scores we provided a percentage of people at optimum strength and flexibility."|4 months|||Participants|||Count of Participants
657605|NCT01918800|Secondary|SF-36|The SF-36 is a validated measure of health-related quality of life. It is sensitive to change, has appropriate psychometric properties and is frequently used in MS studies. Measures of health-related quality of life are recommended in the systematic review of self-management in neurological disorders. The range for the physical component score is 13.6-61.9. The range for the mental component scores is 15.6-70.0.|4 months|||units on a scale||Standard Deviation|Mean
657606|NCT01918800|Secondary|Beck Depression Inventory II (BDI-II)|The self-report, retrospective BDI-II is a validated 21-item self-report measure of depression widely used in MS studies . Each item is scored between 0 and 3. It is reported to have good reliability (Cronbach's alpha of .81) and validity. Assessing for depression is part of the inclusion/exclusion criteria. Excluding subjects with severe depression is necessary to avoid confounding effects of fatigue and depression. Score range (0-63). Higher scores indicate greater depression.|4 months|||units on a scale||Standard Deviation|Mean
657607|NCT01918800|Secondary|Multiple Sclerosis Self Efficacy Scale|The self-report, retrospective MSSE is an 18-item scale of self-efficacy specifically designed for MS patients. This easy to use self-report measure demonstrates internal consistency estimates of about .89 for the full scale and a .75 test-retest correlation. Higher scores on the MSSE indicate higher self-efficacy. Scores range from 180-1800.|4 months|||units on a scale||Standard Deviation|Mean
657608|NCT01918800|Primary|Modified Fatigue Impact Scale|The self-report, retrospective MFIS measures fatigue symptoms. The full-length MFIS consists of 21 items scored 0-4 for a total score between 0 and 84 and has a coefficient alpha of .81. The MFIS provides a total score and scores for each of three subscales (physical, cognitive and psychosocial) and lower scores on the MFIS and its subscales indicate less fatigue. This is the primary outcome measure for the proposed study and is widely used to assess fatigue in MS.|4 months|||units on a scale||Standard Deviation|Mean
657609|NCT01918371|Secondary|Percentage of Phakic Patients With Cataract Surgery in the Study Eye|Phakic patients have intraocular lens implants.|4 Years|All phakic participants with data available.||percentage of participants|||Number
657610|NCT01918371|Secondary|Percentage of Participants Undergoing Incisional Glaucoma Surgery in the Study Eye||4 Years|All participants with data available.||percentage of participants|||Number
657611|NCT01918371|Secondary|Percentage of Participants Undergoing Glaucoma Laser Surgery in the Study Eye||4 Years|All participants with data available.||percentage of participants|||Number
657612|NCT01918371|Secondary|Percentage of Participants With No Change in BCVA From Baseline in the Study Eye|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best).|Baseline, Up to 4 Years|All participants with data available.||percentage of participants|||Number
657613|NCT01918371|Secondary|Percentage of Participants With a Gain (Increase) in BCVA of ≥1 Line From Baseline in the Study Eye|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). A gain of 1 or more lines read correctly from Baseline indicates an improvement of vision.|Baseline, Up to 4 Years|All participants with data available.||percentage of participants|||Number
657614|NCT01918371|Secondary|Percentage of Participants With a Loss (Decrease) in BCVA of ≥1 Line From Baseline in the Study Eye|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). A loss of 1 or more lines read correctly from Baseline indicates a worsening of vision.|Baseline, Up to 4 Years|All participants with data available.||percentage of participants|||Number
657615|NCT01918371|Secondary|Percentage of Participants Undergoing Panretinal Photocoagulation (PRP) Surgery in the Study Eye||4 Years|All participants with data available.||percentage of participants|||Number
657616|NCT01918371|Secondary|Percentage of Participants Undergoing Focal Laser Surgery in the Study Eye||4 Years|All participants with data available.||percentage of participants|||Number
657619|NCT01918371|Secondary|Number of Intravitreal Anti-VEGF Injections in the Study Eye|To be included in the time period analysis, patients must have been enrolled on the study for at least a minimum of 0 weeks, 24 weeks, 50 weeks, 100 weeks, and 150 weeks, respectively, and must have received at least 1 injection during that time period.|0-6 Months, 7-12 Months, Years 1,2,3|All participants with data available.||injections||Standard Deviation|Mean
657620|NCT01918371|Secondary|Time Between Anti-VEGF Injections in the Study Eye|The mean time in months between anti-VEGF Injections.|4 Years|All participants with data available.||months||Standard Deviation|Mean
657621|NCT01918371|Secondary|Time to Improvement to Both 20/40 or Better in BCVA and Improvement in CRT of ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye|Kaplan-Meier estimates of the time to improvement to Both 20/40 or Better in BCVA and Improvement in CRT of ≤250 µm on TD OCT or ≤300 µm on SD OCT. BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.|4 Years|All participants with available data.||months||Full Range|Median
657622|NCT01918371|Secondary|Time to Improvement in CRT of ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye|Kaplan-Meier estimates of the time to improvement in months in CRT of ≤250 µm on TD OCT or ≤300 µm on SD OCT. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.|4 Years|All participants with available data.||months||Full Range|Median
657623|NCT01918371|Secondary|Time to Improvement in BCVA to 20/40 or Better in the Study Eye|Kaplan-Meier estimates of the time to Improvement in months in BCVA to 20/40 or Better. BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). 20/40 or better is equivalent to 14 or more lines read correctly.|4 Years|All participants with available data.||months||Full Range|Median
657624|NCT01918371|Secondary|Time to Improvement of ≥3 Lines in BCVA in the Study Eye|Kaplan-Meier estimates of the time in months to improvement of ≥3 lines in BCVA. BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best).|4 Years|All participants with available data.||months||Full Range|Median
657625|NCT01918371|Secondary|Time to Improvement of ≥2 Lines in BCVA in the Study Eye|Kaplan-Meier estimates of the time in months to improvement of ≥2 lines in BCVA. BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best).|4 Years|All participants with available data.||months||Full Range|Median
657626|NCT01918371|Secondary|Change From Baseline in CRT by OCT in the Study Eye|CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation. A negative change from Baseline indicates improvement.|Baseline, Up to 4 Years|All participants with data available.||µm (microns)||Standard Deviation|Mean
657627|NCT01918371|Secondary|Percentage of Participants With an Increase From Baseline of ≥3 Lines in BCVA in the Study Eye|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). An increase of 3 or more lines read correctly from Baseline indicates improvement.|Baseline, Up to 4 Years|All participants with data available.||percentage of participants|||Number
657628|NCT01918371|Secondary|Percentage of Participants With an Increase From Baseline of ≥2 Lines in BCVA in the Study Eye|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). An increase of 2 or more lines read correctly from Baseline indicates improvement.|Baseline, Up to 4 Years|||percentage of participants|||Number
657629|NCT01918371|Secondary|Change From Baseline in BCVA in the Study Eye|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). A positive change from Baseline indicates improvement.|Baseline, Up to 4 Years|All participants with data available.||lines||Standard Deviation|Mean
657630|NCT01918371|Secondary|Mean BCVA in the Study Eye|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best).|UP to 4 Years|All participants with data available.||lines||Standard Deviation|Mean
657631|NCT01918371|Secondary|Percentage of Participants With Both BCVA 20/40 or Better or CRT ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.|Up to 4 Years|All participants with data available.||percentage of participants|||Number
657632|NCT01918371|Secondary|Percentage of Participants With CRT of ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye|CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.|Up to 4 Years|All participants with data available.||percentage of participants|||Number
657633|NCT01918371|Secondary|Percentage of Participants With BCVA of 20/40 or Better in the Study Eye|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). 20/40 or better is equivalent to 14 or more lines read correctly|Up to 4 Years|All participants with data available.||percentage of participants|||Number
657634|NCT01918371|Primary|Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 11|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.|Up to Time of Injection 11 (Up to 4 Years)|All participants with data available up to time of Injection 11.||percentage of participants|||Number
657635|NCT01918371|Primary|Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 10|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.|Up to Time of Injection 10 (Up to 4 Years)|All participants with data available up to time of Injection 10.||percentage of participants|||Number
657636|NCT01918371|Primary|Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 9|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.|Up to Time of Injection 9 (Up to 4 Years)|All participants with data available up to time of Injection 9.||percentage of participants|||Number
657637|NCT01918371|Primary|Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 8|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.|Up to Time of Injection 8 (Up to 4 Years)|All participants with data available up to time of Injection 8.||percentage of participants|||Number
657638|NCT01918371|Primary|Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 7|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.|Up to Time of Injection 7 (Up to 4 Years)|All participants with data available up to time of Injection 7.||percentage of participants|||Number
657639|NCT01918371|Primary|Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 6|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.|Up to Time of Injection 6 (Up to 4 Years)|All participants with data available up to time of Injection 6.||percentage of participants|||Number
657640|NCT01918371|Primary|Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 5|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.|Up to Time of Injection 5 (Up to 4 Years)|All participants with data available up to time of Injection 5.||percentage of participants|||Number
657641|NCT01918371|Primary|Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 4|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.|Up to Time of Injection 4 (Up to 4 Years)|All participants with data available up to time of Injection 4.||percentage of participants|||Number
657642|NCT01918371|Primary|Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 3|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.|Up to Time of Injection 3 (Up to 4 Years)|All participants with data available up to time of Injection 3.||percentage of participants|||Number
657643|NCT01918371|Primary|Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 2|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.|Up to Time of Injection 2 (Up to 4 Years)|All participants with data available up to time of Injection 2.||percentage of participants|||Number
657644|NCT01918332|Primary|LDL-C Percentage Changes at Week 8 From Baseline|LDL-C percentage changes of the rosuvastatin 20mg and rosuvastatin placebo groups at Week 8 from baseline|8 weeks|FAS||percent change||95% Confidence Interval|Least Squares Mean
657647|NCT01918306|Secondary|Time to Progression - (Phase II)|Time to Progression (TTP) is calculated with the corresponding 95% confidence interval at the dose recommended for phase II. TTP is defined as the time from randomization until objective tumor progression, this does not include deaths unrelated to disease progression.|From time of randomization to disease progression, up to 104 weeks|||days to progression||Full Range|Median
657648|NCT01918306|Secondary|Clinical Benefit Rate - (Phase II)|"Clinical Benefit Rate (CBR) is defined as complete response (CR) plus partial response (PR) plus stable disease (SD) for 6 months.
Clinical Benefit Rate (CBR) is calculated with the corresponding 95% confidence intervals at the dose recommended for phase II.
Response and progression will be evaluated using the international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 performed at baseline and every 8 weeks will be compared."|at 32 weeks|Study closed early and response and progression were not evaluated at 32 weeks.|||||
657649|NCT01918306|Secondary|Number of Patients With Dose-limiting Toxicities Per NCI Common Terminology for Adverse Events (CTCAE) - (Phase Ib)|Number of patients with Grade 3 and 4 toxicities per NCI Common Terminology for Adverse Events (CTCAE) version 4.0 requirements.|During the first 4 weeks|Less than 2 patients in cohort 1 and 2 experienced DLT, therefore no patients enrolled in arm 1PHIbB.||participants|||Number
657650|NCT01918306|Primary|Percentage of Patients Achieving Overall Response - (Phase II)|"The primary efficacy endpoint is overall response rate (ORR) of cisplatin + GDC-0941 versus cisplatin alone in patients with AR- TN MBC. ORR is defined as the percentage of subjects achieving complete response (CR) plus partial response (PR) as their best response by RECIST version 1.1 for targeted lesions and assessed by CT, MRI scan.
Objective responses, was estimated by the overall tumor burden at baseline (targeted lesions) in which subsequent measurements were performed every 8 weeks using the Solid Tumor Response Criteria (RECIST) v1.1 were compared. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters."|at 8 weeks|Phase 1-Initial and Max tolerated dose of GCD-0941 was the same, no dose de-escalation occurred. Phase 2, 1 of the 2 patients from the Cisplatin only arm did crossover to the Crossover Cisplatin and GDC-0941 arm. 3 patients randomized to Cisplatin + GDC -0941 arm, and 1 crossover patient, for a total of 4 patients who received Cisplatin+GDC-0941.||Participants|||Count of Participants
657651|NCT01918306|Primary|Maximum Tolerated Dose(MTD) of GDC-0941 and Recommended Phase II Dose of GDC-0941 Given in Combination With Cisplatin. - (Phase Ib)|"GDC-0941 dose will start at 260 mg (maximum dose). De-escalation of the intensity of the dose (if necessary) will proceed among cohorts of 3 patients according to a standard 3+3 algorithm beginning at the highest dose level of GDC-0941 260mg.
MTD is defined as the highest dose at which a DLT is experienced >= 1 out of 6 patients.
A cohort of 3 patients was initially enrolled in the GDC-0941 arm at dose 260mg PO days 2-6, 9-13, 16-20, 23-27 of 28 day cycle
If no patient in the first cohort of 3 experiences a DLT, an additional cohort of 3 patients will be treated at the same dose level.
If 1 patient experiences a DLT in the first cohort, an additional cohort of 3 patients will be treated at the same dose level.
If ≤1 patient has a DLT in 6 treated at this same dose, this will be considered a tolerable dose to move to phase II.
If 2 or more patients in 3 or 6 patients treated at a given dose experience DLT, the dose will be de-escalated to the next lower dose level."|4 weeks|A cohort of 3 was enrolled at dose 260mg. No DLT was found. Then a second cohort of 260mg was enrolled. One of them experienced DLT.||mg|||Number
657652|NCT01918085|Primary|Peel Force|"The peel force was measured with a tensile tester which measured the force needed to remove the the adhesive strip from the skin with a constant speed 304mm/min and a mean angel of 90 degrees.
The peel force was measured on all participants in the flow module. However, sometimes the measurements failed and therefore did not provide a result. In example a wheel chair user was included and non of peel force measurements were succesful on the subject. The rest of the failed measurements were distributed randomly between the subjects."|1 hour|"Some of the measurements failed. i.e one subject was a wheel chair user and the peel force could not be measured on this person.
Only the measurements that did not fail were included in the analysis"||Newton||Standard Deviation|Mean
657653|NCT01918033|Secondary|Change From Baseline in Eye Symptom Score Reported in Participant Diaries|Participants evaluated themselves in their daily allergy diaries for eye (itching) symptoms (score of 0=none to 3=eye is itchy, requiring frequent rubbing of eye). Eye symptom scores could range from 0 to 3, with a higher score indicating greater eye itchiness.|Baseline and Day 3, Week 1, Week 2|The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for participant-rated eye symptom score.||Score on a Scale||95% Confidence Interval|Least Squares Mean
657654|NCT01918033|Secondary|Change From Baseline in Nasal Symptom Sub-Scores Reported in Participant Diaries|Participants evaluated themselves in their daily allergy diaries for nasal symptoms of: sneezing (daily frequency of attacks; score of 0=less than 1 time to 3=11+ times), rhinorrhea (daily frequency of blowing nose; score of 0=less than 1 time to 3=11+ times), nasal congestion (score of 0=less than nasal blockage without oral breathing to 3=severe nasal blockage causing prolonged oral breathing in a day), and nasal itching (score of 0=none to 3=nose is itchy, requiring frequent rubbing or blowing nose). Each nasal symptom sub-score could range from 0 to 3, with a higher sub-score indicating more frequent/severe nasal symptoms.|Baseline and Day 3, Week 1, Week 2|The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for participant-rated nasal symptom score.||Score on a Scale||95% Confidence Interval|Least Squares Mean
657655|NCT01918033|Secondary|Change From Baseline in Score on Interference With Daily Activities Assessed by the Investigator|The investigator interviewed participants at Baseline, Day 3, Week 1 and Week 2 to evaluate interference with daily activities according to the following scale: 0=none, 1=nasal symptom interferes with daily activities from time to time (+), 2=between 1 and 3 (++), and 3=nasal symtom interferes with daily activity often (+++). Interference with daily activities scores could range from 0 to 3, with a higher score indicating greater interference with daily activities.|Baseline and Day 3, Week 1, Week 2|The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for interference with daily activities.||Score on a Scale||95% Confidence Interval|Least Squares Mean
657713|NCT01916928|Primary|The Presence or Absence of Cell Free Fetal DNA in Maternal Blood in the Setting of a Failed Pregnancy.|Percentage of participants with the presence of cell free fetal DNA in maternal circulation after miscarriage of intrauterine fetal demise|During initial presentation for treatment|||percentage of participants|||Number
657656|NCT01918033|Secondary|Number of Participants With Moderate-to-Remarkable Improvement in Global Improvement Assessed by the Investigator|The investigator comprehensively evaluated participants on global improvement according to 5 grades: 1=remarkably improved, 2= moderately improved, 3=slightly improved, 4=unchanged, and 5=aggravated. The number of participants who were evaluated as remarkably improved and moderately improved was calculated.|Day 3, Week 1, Week 2|The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for global improvement.||Participants|||Number
657657|NCT01918033|Secondary|Change From Baseline in Eye Symptom Score Assessed by the Investigator|The investigator interviewed and examined participants for eye (itching) symptoms (score of 0=none to 3=eye is itchy, requiring frequent rubbing of eye). Eye symptom scores could range from 0 to 3, with a higher score indicating greater eye itchiness.|Baseline and Day 3, Week 1, Week 2|The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for eye symptom score as assessed by the investigator.||Score on a Scale||95% Confidence Interval|Least Squares Mean
657658|NCT01918033|Secondary|Change From Baseline in Nasal Finding Score Assessed by the Investigator|The investigator conducted rhinoscopic examinations on participants to evaluate: swelling of inferior nasal concha mucosa (INCM) (score of 0=none to 3=middle nasal concha is not visible), coloring of inferior nasal concha mucosa (INCM) (score of 0=normal to 3=pale), and nasal discharge production (NDP) (score of 0=none to 3=congesting). The score for each nasal finding component could range from 0 to 3, with a higher score indicating more severe symptoms.|Baseline and Day 3, Week 1, Week 2|The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for nasal finding score.||Score on a Scale||95% Confidence Interval|Least Squares Mean
657659|NCT01918033|Secondary|Change From Baseline in Nasal Symptom Sub-Scores Assessed by the Investigator|The investigator interviewed and examined participants to evaluate for nasal symptoms of: sneezing (daily frequency of attackes; score of 0=less than 1 time to 3=11+ times), rhinorrhea (daily frequency of blowing nose; score of 0=less than 1 time to 3=11+ times), nasal congestion (score of 0=less than nasal blockage without oral breathing to 3=severe nasal blockage causing prolonged oral breathing in a day), and nasal itching (score of 0=none to 3=nose is itchy, requiring frequent rubbing or blowing nose). Nasal symptom sub-scores could range from 0 to 3, with a higher nasal symptom sub-score indicating more frequent/severe nasal symptoms.|Baseline and Day 3, Week 1, Week 2|The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for nasal symptom sub-scores as assessed by the investigator.||Score on a Scale||95% Confidence Interval|Least Squares Mean
657660|NCT01918033|Secondary|Change From Baseline in Total Nasal Symptom Score (TNSS) Assessed by the Investigator at Day 3 and Week 1|The investigator interviewed and examined participants to evaluate for nasal symptoms of: sneezing (daily frequency of attacks; score of 0=less than 1 time to 3=11+ times), rhinorrhea (daily frequency of blowing nose; score of 0=less than 1 time to 3=11+ times), nasal congestion (score of 0=less than nasal blockage without oral breathing to 3=severe nasal blockage causing prolonged oral breathing in a day), and nasal itching (score of 0=none to 3=nose is itchy, requiring frequent rubbing or blowing nose). The TNSS is the sum of the 4 nasal symptom sub-scores. TNSS scores could range from 0 to 12, with a higher score indicating more frequent/severe nasal symptoms.|Baseline and Day 3, Week 1|The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for TNSS.||Score on a Scale||95% Confidence Interval|Least Squares Mean
657661|NCT01918033|Primary|Number of Participants Discontinuing Study Drug Due to an AE|An AE is defined as any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of the study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug, is also an AE. The number of participants who discontinued study drug, whether permanently or temporarily, due to an AE was summarized.|Up to Week 2|The ASaT population consisted of all participants who received at least one dose of study drug.||Participants|||Number
657662|NCT01918033|Primary|Number of Participants Experiencing an Adverse Event (AE)|An AE is defined as any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of the study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug, is also an AE. The number of participants who experienced an AE, regardless of causality or severity, was summarized.|Up to Week 4|The All-Subjects-as-Treated (ASaT) population consisted of all participants who received at least one dose of study drug.||Participants|||Number
657663|NCT01918033|Primary|Change From Baseline in Total Nasal Symptom Score (TNSS) Assessed by the Investigator at Week 2|The investigator interviewed and examined participants to evaluate for nasal symptoms of: sneezing (daily frequency of attacks; score of 0=less than 1 time to 3=11+ times), rhinorrhea (daily frequency of blowing nose; score of 0=less than 1 time to 3=11+ times), nasal congestion (score of 0=less than nasal blockage without oral breathing to 3=severe nasal blockage causing prolonged oral breathing in a day), and nasal itching (score of 0=none to 3=nose is itchy, requiring frequent rubbing or blowing nose). The TNSS is the sum of the 4 nasal symptom sub-scores. TNSS scores could range from 0 to 12, with a higher score indicating more frequent/severe nasal symptoms.|Baseline and Week 2|The Full Analysis Set (FAS) population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for TNSS.||Score on a Scale||95% Confidence Interval|Least Squares Mean
657664|NCT01917812|Secondary|Mean Daily Aerobic Activity Time|Note that the study occurred over two study phases after the 1-week blinded run-in. In the first 2-week phase, participants were randomized to unblinded or blinded tracking. In the second 2-week phase, the unblinded participants were randomized to receive smart texts or no texts.|Change from 3 weeks mean daily aerobic activity time at 5 weeks (end of smart text messaging intervention)|||minutes per day||Standard Deviation|Mean
657714|NCT01916681|Secondary|Maternal Morbidity||Enrollment through discharge|||participants|||Number
657715|NCT01916681|Secondary|Chorioamnionitis||Enrollment through deischarge|||participants|||Number
657665|NCT01917812|Secondary|Mean Daily Activity Time|Note that the study occurred over two study phases after the 1-week blinded run-in. In the first 2-week phase, participants were randomized to unblinded or blinded tracking. In the second 2-week phase, the unblinded participants were randomized to receive smart texts or no texts.|Change from 3 weeks mean daily activity time at 5 weeks (end of smart text messaging intervention)|||minutes per day||Standard Deviation|Mean
657666|NCT01917812|Primary|Mean Daily Step Count|Note that the study occurred over two study phases after the 1-week blinded run-in. In the first 2-week phase, participants were randomized to unblinded or blinded tracking. In the second 2-week phase, the unblinded participants were randomized to receive smart texts or no texts.|Change from 3 weeks mean daily step count at 5 weeks (end of smart text messaging intervention)|||steps per day||Standard Deviation|Mean
657667|NCT01917812|Secondary|Mean Daily Aerobic Activity Time|"Defined as the time spent walking continuously for >10 minutes without breaking for more than a minute.
Note that the study occurred over two study phases after the 1-week blinded run-in. In the first 2-week phase, participants were randomized to unblinded or blinded tracking. In the second 2-week phase, the unblinded participants were randomized to receive smart texts or no texts."|Change from baseline mean daily aerobic activity time at 3 weeks (end of unblinded digital activity tracker intervention)|||minutes per day||Standard Deviation|Mean
657668|NCT01917812|Secondary|Mean Daily Activity Time|Note that the study occurred over two study phases after the 1-week blinded run-in. In the first 2-week phase, participants were randomized to unblinded or blinded tracking. In the second 2-week phase, the unblinded participants were randomized to receive smart texts or no texts.|Change from baseline mean daily activity time at 3 weeks (end of unblinded digital activity tracker intervention)|||minutes per day||Standard Deviation|Mean
657669|NCT01917812|Primary|Mean Daily Step Count|Note that the study occurred over two study phases after the 1-week blinded run-in. In the first 2-week phase, participants were randomized to unblinded or blinded tracking. In the second 2-week phase, the unblinded participants were randomized to receive smart texts or no texts.|Change from baseline mean daily step count at 3 weeks (end of unblinded digital activity tracker intervention)|||steps per day||Standard Deviation|Mean
657670|NCT01917773|Primary|Compared Colonic Motility Index From Fasting to Post Octreotide Infusion|"Colonic motility was measured using a solid-state catheter. The catheter had 36 sensors spaced 5-cm apart for the first 15 sensors and 1-cm apart for the remaining sensors. Pressures were transmitted to a transducer and recorded on a personal computer system (Medical Measurement Systems USA, Dover, NH).
Motility index (MI) was calculated using the Medical Measurement Systems computer program. The MI represents the area under the curve of the pressure tracing for a certain period (21). The MI was calculated for each channel. The MIs from all of the channels were then averaged to give each patient 1 average MI for the particular period under study. In this study, MI was calculated for the periods of 15, 30, and 45 minutes before and after infusion of octreotide. MI is reported as millimeters of mercury (mmHg) per 15, 30, or 45 minutes."|Average MI for all patients was calculated over 15-minutes, 30-minutes and 45- minutes before and after administration of octreotide.|||mm Hg||95% Confidence Interval|Mean
657671|NCT01917656|Secondary|Number of Treatment Emergent Adverse Events (TEAEs) During Ramadan (Fasting), Based on Each Subject's Individual Fasting Period.|"A serious AE was an experience that at any dose resulted in any of the following: Death, a life-threatening experience, in-patient hospitalisation or prolongation of existing hospitalisation, a persistent or significant disability or incapacity, congenital anomaly or birth defect, important medical events.
Mild - no or transient symptoms, no interference with the subject's daily activities Moderate - marked symptoms, moderate interference with the subject's daily activities Severe - considerable interference with the subject's daily activities, unacceptable"|Day -1 to day 29|Safety analysis set||Events/1000 years of patient exposure|||Number
657672|NCT01917656|Secondary|Number of Confirmed Hypoglycaemic Episodes During Ramadan (Fasting), Based on Each Subject's Individual Fasting Period.||Day -1 to day 29|Safety analysis set||Events/1000 years of patient exposure|||Number
657673|NCT01917656|Secondary|Subjects Who at End of Treatment (4 Weeks Post Ramadan) Achieve (y/n): HbA1c Below 7.0% (53 mmol/Mol), and no Confirmed Hypoglycaemic Episodes|Subjects who at end of treatment (Visit 14, 4 weeks post Ramadan) achieve (y/n): HbA1c below 7.0% (53 mmol/mol) (ADA target)|Visit 14 (4 weeks post Ramadan)|Full analysis set||percentage (%) of subjects|||Number
657674|NCT01917656|Secondary|Subjects Who at End of Treatment (4 Weeks Post Ramadan) Achieve (y/n): HbA1c Below 7.0% (53 mmol/Mol) (ADA Target)|Subjects who at end of treatment (Visit 14, 4 weeks post Ramadan) achieve (y/n): HbA1c below 7.0% (53 mmol/mol) (ADA target)|Visit 14 (4 weeks post Ramadan)|Full analysis set||percentage (%) of subjects|||Number
657675|NCT01917656|Secondary|Change From Baseline to End of Ramadan in Body Weight||Baseline, day 29|Full analysis set (FAS). The number of subjects in FAS were 171 (Liraglutide) and 169 (Sulfonylurea), few subjects did not contribute to this analysis.||kg||Standard Error|Least Squares Mean
657676|NCT01917656|Secondary|Change From Baseline to End of Ramadan in Glycosylated Haemoglobin (HbA1c)|The level of glycosylated haemoglobin in blood was used to assess the glycaemic control of the patients during the time period described.|Baseline, day 29|Full analysis set (FAS). The number of subjects in FAS were 171 (Liraglutide) and 169 (Sulfonylurea), few subjects did not contribute to this analysis.||Percent (%) glycosylated haemoglobin||Standard Deviation|Mean
657677|NCT01917656|Secondary|Change From Baseline to End of Ramadan in Fasting Plasma Glucose|The changes from baseline measured postbaseline (i.e., the changes measured on visit 8 and 12) entered as the dependent variables, and visit, treatment, country, and the stratification variables were included as fixed factors and the corresponding values for the specific endpoint measured at randomisation as covariate.|Baseline, day 29|Full analysis set (FAS). The number of subjects in FAS were 171 (Liraglutide) and 169 (Sulfonylurea), few subjects did not contribute to this analysis.||mmol/L||Standard Deviation|Mean
657678|NCT01917656|Secondary|Change From Start of Ramadan to End of Ramadan in Fasting Plasma Glucose (FPG)|The level of FPG in the blood of fasting patients was addressed to monitor glycaemic control during the period described.|Day -1, day 29|Full analysis set (FAS). The number of subjects in FAS were 171 (Liraglutide) and 169 (Sulfonylurea), few subjects did not contribute to this analysis.||mmol/L||Standard Deviation|Mean
657679|NCT01917656|Secondary|Fructosamine at End of Ramadan|The fructosamine values at the end of Ramadan (visit 12) were presented|Day 29|Full analysis set (FAS). The number of subjects in FAS were 171 (Liraglutide) and 169 (Sulfonylurea), few subjects did not contribute to this analysis.||umol/L||Standard Deviation|Mean
657680|NCT01917656|Primary|Change in Fructosamine From Start of Ramadan to End of Ramadan|The level of fructosamine in the blood was used to assess the glycaemic control in the patients during the time period described- from start of Ramadan (day -1, visit 8) to end of Ramadan (day 29, visit 12).|Day -1, day 29|Full analysis set (FAS). The number of subjects in FAS were 171 (Liraglutide) and 169 (Sulfonylurea), few subjects did not contribute to this analysis.||umol/L||Standard Deviation|Mean
657681|NCT01917526|Secondary|The Causes of Hypoxemia|Causes of hypoxemia in each participant in PACU will be recorded|In PACU (1 hr after anesthesia)|||causes of hypoxemia|||Number
657682|NCT01917526|Primary|Number of Participants With Hypoxemia in Both Groups|Hypoxemia is defined as oxygen saturation < 94%. We record number of participants with hypoxemia in both groups|In PACU (1 hr after anesthesia)|||number of participants|||Number
657683|NCT01917344|Secondary|Tremor as Determined Through Neurological Evaluation||During period of evaluation, approximately 8 hours||||||
657684|NCT01917344|Secondary|Diffusion Tensor Imaging (DTI) Findings Through MRI||During period of evaluation, approximately 8 hours||||||
657685|NCT01917344|Secondary|Volumetric MRI Findings||During period of evaluation, approximately 8 hours||||||
657686|NCT01917344|Secondary|Electroencephalogram (EEG) Findings||During period of evaluation, approximately 8 hours||||||
657687|NCT01917344|Secondary|Full Scale Intelligence Quotient (IQ)||During period of evaluation, approximately 8 hours||||||
657688|NCT01917344|Primary|Phenylalanine Level in the Brain as Determined by MR Spectroscopy and in Blood|Brain Phe levels (umol/L) using MRI correlated spectroscopy and Blood Phe levels (umol/L) obtained on the same day.|During period of evaluation, approximately 8 hours|||umol/L||Standard Deviation|Mean
657689|NCT01917214|Secondary|Correlation of Duration and Number of Participants With CR (Complete Response), PR (Partial Response), SD (Stable Disease) and PD (Progressive Disease) From Initiation of Sutent Therapy|Number of participants with CR, PR, SD and PD responses assessed as per clinical and radiological documentation in clinical notes for different durations of treatment with Sutent were reported. CR was defined as complete resolution of all visible disease, PR was defined as partial reduction in size of visible disease, SD was defined as no change in size of visible disease, and PD was defined as an increase in visible disease.|From initiation of treatment up to 72 months|Participants diagnosed with mRCC during the time period between 1 January 2006 and 31 December 2011 and received Sutent as a first-line therapy. Here, “n” signifies those participants who were evaluable for this measure for specified treatment duration.||participants|||Number
657690|NCT01917214|Secondary|Correlation of Dosage and Number of Participants With CR (Complete Response), PR (Partial Response), SD (Stable Disease) and PD (Progressive Disease) From Initiation of Sutent Therapy|"Number of participants with CR, PR, SD and PD responses assessed as per clinical and radiological documentation in clinical notes for different Sutent doses were reported. CR was defined as complete resolution of all visible disease, PR was defined as partial reduction in size of visible disease, SD was defined as no change in size of visible disease, and PD was defined as an increase in visible disease. Here other refers to Sutent 12.5 mg."|From initiation of treatment up to 72 months|Participants diagnosed with mRCC during the time period between 1 January 2006 and 31 December 2011 and received Sutent as a first-line therapy. Here, “n” signifies those participants who were evaluable for this measure for specified Sutent treatment.||participants|||Number
657691|NCT01917214|Secondary|Time to Treatment Failure From Initiation of Sutent Therapy|Time to treatment failure was defined as the time from initiation of study treatment to the date of the first documentation of Progressive Disease (PD), symptomatic deterioration, death due to any cause, or discontinuation of treatment due to AE, refusal or other reason. PD was defined as an increase in visible disease.|From initiation of treatment up to 72 months|Participants diagnosed with mRCC during the time period between 1 January 2006 and 31 December 2011 and received Sutent as a first-line therapy. Here, “N” (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||months||95% Confidence Interval|Median
657692|NCT01917214|Secondary|Overall Survival (OS)|Overall survival was the duration from diagnosis of disease to death. Overall survival was compared for those who had received best supportive care to those who received Sutent as first-line therapy.|From diagnosis until death (up to 72 months)|Participants diagnosed with mRCC during time period between 1 January 2006 and 31 December 2011 and received Sutent or Best Supportive Care as a first-line therapy. Here, “N” (number of participants analyzed)=participants who were evaluable for this outcome measure. “n”=participants who were evaluable for this measure for each specified treatment.||months||95% Confidence Interval|Median
657693|NCT01917214|Secondary|Objective Response Rate - Percentage of Participants With Objective Response From Initiation of Sutent Therapy|Percentage of participants with objective response based on assessment of complete response (CR) or partial response (PR) as per clinical and radiological documentation in clinical notes. CR was defined as complete resolution of all visible disease, whereas PR was defined as partial reduction in size of visible disease.|From initiation of treatment up to 72 months|Participants diagnosed with mRCC during the time period between 1 January 2006 and 31 December 2011 and received Sutent as a first-line therapy.||percentage of participants|||Number
657694|NCT01917214|Primary|Progression-Free Survival (PFS) From Initiation of Sutent Therapy|PFS was defined as the time from initiation of Sutent (sunitinib malate) to first documentation of tumor progression or to death due to any cause, whichever occurred first. Time to treatment failure was used as a surrogate for PFS as PFS could not be determined due to retrospective nature of this study.|From initiation of treatment up to 72 months|Time to treatment failure (given in outcome measure 4) was used as a surrogate for PFS due to the lack of consistent regular restaging scans in clinical practice.|||||
657716|NCT01916681|Secondary|Regional Anesthesia||During delivery|||participants|||Number
657717|NCT01916681|Secondary|Time to Active Labor||Start of induction to active labor|||Hours||Inter-Quartile Range|Median
657723|NCT01916590|Primary|Pain Scores Will be Collected for 48 Hours After ACL Reconstruction|Pain scores will be collected for 48 hours after ACL reconstruction with a patellar tendon graft or allograft and used to measure the effectiveness of the femoral catheter vs. single shot femoral nerve block|48 hours after surgery|Because of the lack of enrollment no data was collected|||||
657724|NCT01916304|Secondary|Relative Percent Change From Baseline in Serum Thyroid Stimulating Hormone|Blood samples were collected and samples were analyzed according to the local Quality System. A negative change from Baseline indicated improvement.|Baseline, Month 2 (± 2 weeks) and Month 4 (± 4 weeks) after inclusion into study.|Participants from the intent-to-treat population, with data available for analysis.||percent change||Inter-Quartile Range|Median
657725|NCT01916304|Secondary|Absolute Serum Thyroid Stimulating Hormone Values|Blood samples were collected and samples were analyzed according to the local Quality System.|Baseline, Month 2 (± 2 weeks) and Month 4 (± 4 weeks) after inclusion into study.|Participants from the intent-to-treat population, with data available for analysis.||mIU/mL||Inter-Quartile Range|Mean
657726|NCT01916304|Secondary|Percentage of Participants That Obtained a Thyroid Stimulating Hormone (TSH) Between 0.4-2.5 mU/L|Blood samples were collected and samples were analyzed according to the local Quality System.|Month 4 (± 4 weeks) after inclusion into study.|Participants from the intent-to-treat population, with data available for analysis.||percentage of participants|||Number
657727|NCT01916304|Secondary|Magnitude of the Change in Daily Dose Needed|Magnitude was determined via a change table which provides the percentage of participants that needed a change in Daily Dose (μg/day) of -25 μg, -12.5 μg, -6.25 μg, -5.35 μg, 0 μg or +12.5 μg.|2 months (± 2 weeks) after switch to sodium formulation.|Participants from the intent-to-treat population, with data available for analysis.||percentage of participants|||Number
657728|NCT01916304|Primary|Percentage of Participants That Do Not Need a Change of Dose|Dose change was determined by physician according to their clinical judgement.|2 months (± 2 weeks) after switch to sodium formulation.|Participants from the intent-to-treat population, with data available for analysis.||percentage of participants||95% Confidence Interval|Number
657729|NCT01916226|Secondary|Mean Change From Baseline in the Combined Nasal and Ocular Reflective Total Symptom Score (rTSS = rTNSS+rTOSS) Over the Entire Treatment Period|The rTSS is the sum of the rTNSS and the rTOSS. The rTNSS score is the sum of the four individual symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing. Each symptom is scored on a scale ranging from 0 to 3; the rTNSS ranges from 0 (none) to 12 (severe). Each individual symptom was evaluated using a scale of 0 (none), 1 (mild), 2 (moderate), or 3 (severe). The rTOSS assessment is comprised of the sum of the three symptom scores for tearing/watering, itching/burning, and eye redness. Each symptom is scored on a scale of 0 to 3: 0, none; 1, mild; 2, moderate; or 3, severe. The rTOSS ranges from 0 (none) to 9 (severe). The reflective assessment scores participants' symptoms over the previous 24 hours. The participants themselves scored nasal and ocular symptoms in an e-diary. Baseline is defined as the arithmetic average of the rTSS recorded on the morning of randomization and on each of the six preceding days.|Baseline through the entire treatment period (2 weeks)|Ocular Population. Change from Baseline was calculated as the 2-week average minus the Baseline value.n||Scores on a scale||Standard Error|Mean
657730|NCT01916226|Secondary|Mean Change From Baseline in the AM Pre-dose Instantaneous Total Ocular Symptom Score (iTOSS) Over the Entire Treatment Period|The iTOSS is an eye assessment that comprises the sum of the three symptom scores for tearing/watering, itching/burning, and eye redness. Each symptom is scored on a scale of 0 to 3: 0, none; 1, mild; 2, moderate; 3, severe. The iTOSS ranges from 0 (none) to 9 (severe). The instantaneous assessment scores the participants' ocular symptoms at the time of the assessment, or at that “instant.” The participants themselves scored ocular symptoms in an e-diary once each morning prior to administering study drug. Baseline is defined as the arithmetic average of the iTOSS recorded on the morning of randomization and on each of the six preceding days. A participant may have had as few as 4 days’ worth of data contributing to the Baseline average. The 2-week symptom score was defined as the average of the values recorded on the day after randomization and the following 13 days. Change from Baseline was thus calculated as the 2-week average minus the Baseline value.|Baseline through the entire treatment period (2 weeks)|Ocular Population||Scores on a scale||Standard Error|Mean
657731|NCT01916226|Secondary|Mean Change From Baseline in the AM Pre-dose Reflective Total Ocular Symptom Score (rTOSS) Over the Entire Treatment Period|The rTOSS is an eye assessment that comprises the sum of the three symptom scores for tearing/watering, itching/burning, and eye redness. Each symptom is scored on a scale of 0 to 3: 0, none; 1, mild; 2, moderate; 3, severe. The rTOSS ranges from 0 (none) to 9 (severe). The reflective assessment scores the participants' ocular symptoms over the preceding 24 hours. The participants themselves scored ocular symptoms in an e-diary. Baseline arithmetic is defined as the average of the rTNSS recorded on the morning of randomization and on each of the six preceding days. A participant may have had as few as 4 days’ worth of data contributing to the Baseline average. The 2-week symptom score was defined as the average of the values recorded on the day after randomization and the following 13 days. Change from Baseline was thus calculated as the 2-week average minus the Baseline value.|Baseline through the entire treatment period (2 weeks)|Ocular Population: all ITT participants with a Baseline rTOSS of 4 or greater||Scores on a scale||Standard Error|Mean
657732|NCT01916226|Secondary|Mean Change From Baseline in the AM Pre-dose Instantaneous Total Nasal Symptom Score (iTNSS) Over the Entire Treatment Period|The iTNSS score is the sum of the four individual symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing. Each symptom is scored on a scale ranging from 0 to 3; the iTNSS ranges from 0 (none) to 12 (severe). The symptoms were evaluated using a scale of 0 (none), 1 (mild), 2 (moderate), or 3 (severe). The instantaneous assessment of the TNSS scores the four nasal symptoms at the time of the assessment, or at that “instant.” The participants themselves scored nasal symptoms in an e-diary once each morning prior to administering study drug. Baseline is defined as the arithmetic average of the iTNSS recorded on the morning of randomization and on each of the six preceding days. A participant may have had as few as 4 days’ worth of data contributing to the Baseline average. The 2-week symptom score was defined as the average of the values recorded on the day after randomization and the following 13 days.|Baseline through the entire treatment period (2 weeks)|ITT Population. Change from Baseline was analyzed for only those participants who were available for assessment at Baseline and at Weeks 1 and 2. Change from Baseline was calculated as the 2-week average minus the Baseline value.||Scores on a scale||Standard Error|Mean
657733|NCT01916226|Secondary|Mean Change From Baseline in the Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) Overall Score at Visit 3/Early Withdrawal.|The NRQLQ is a 16-item, validated, self-administered, disease (allergic rhinitis)-specific quality of life instrument that measures the functional problems most troublesome to participants with nocturnal allergy symptoms over a one-week interval. Each question is scored on a 7-point scale from 0 (not troubled) to 6 (extremely troubled). Items are grouped into four domains: sleep problems (4 items), sleep time problems (5 items), symptoms on waking in the morning (4 items), and practical problems (3 items). An overall score was calculated from the individual item scores. All items are weighted equally. A mean score is calculated across all items within each domain. The overall score is the mean across all items and ranges from 0 (not troubled) to 6 (extremely troubled). Higher scores reflect a lower quality of life. Change from Baseline was calculated as the 2-week average minus the Baseline value.|Baseline and Visit 3 (Study Day 14 +/- 2 days)/Early Withdrawal|ITT Population||Scores on a scale||Standard Error|Mean
657734|NCT01916226|Secondary|Mean Change From Baseline in the Individual AM Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion, Nasal Itching, and Sneezing Over the Entire Treatment Period|Each individual symptom was evaluated using a scale of 0 (none), 1 (mild), 2 (moderate), or 3 (severe).The reflective assessment scores the four nasal symptoms over the previous 24 hours. The participants themselves scored nasal symptoms in an e-diary. Baseline is defined as the arithmetic average of the individual AM reflective nasal symptom scores recorded on the morning of randomization and on each of the six preceding days. A participant may have had as few as 4 days’ worth of data contributing to the Baseline average. The 2-week symptom score was defined as the average of the values recorded on the day after randomization and the following 13 days. Change from Baseline was thus calculated as the 2-week average minus the Baseline value.|Baseline through the entire treatment period (2 weeks)|ITT Population. Change from Baseline was analyzed for only those participants who were available for assessment at Baseline and at Weeks 1 and 2.||Scores on a scale||Standard Error|Mean
657735|NCT01916226|Primary|Mean Change From Baseline (CFB) in the Individual AM Reflective Total Nasal Symptom Scores (rTNSS) Over the Entire Treatment Period|The rTNSS score is the sum of the four individual symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing. Each symptom is scored on a scale ranging from 0 to 3; the rTNSS ranges from 0 (none) to 12 (severe). Each individual symptom was evaluated using a scale of 0 (none), 1 (mild), 2 (moderate), or 3 (severe). The reflective assessment of the TNSS scores the four nasal symptoms over the previous 24 hours. The participants themselves scored nasal symptoms in an e-diary. Baseline is defined as the arithmetic average of the rTNSS recorded on the morning of randomization and on each of the six preceding days. A participant may have had as few as 4 days’ worth of data contributing to the Baseline average. The 2-week symptom score was defined as the average of the values recorded on the day after randomization and the following 13 days. Change from Baseline was thus calculated as the 2-week average minus the Baseline value.|Baseline through the entire treatment period (2 weeks)|Intent-to-Treat (ITT) Population: all participants who were randomized and received at least one dose of study medication. Change from Baseline was analyzed for only those participants who were available for assessment at Baseline and at Weeks 1 and 2.||Scores on a scale||Standard Error|Mean
657736|NCT01916109|Primary|Pathologic Complete Response Rate (<pT0)|The absence of carcinoma (pT0 disease) and the absence of microscopic lymph node metastases (N0) on the final cystectomy specimen.|1 year|||participants|||Number
657737|NCT01914926|Primary|Percent of Patients Reaching Target HR<100bpm Within 30 Minutes|Percent of patient who reached a HR<100bpm within 30 minutes from baseline.|30 minutes|||percentage of participants|||Number
657738|NCT01915914|Secondary|Change From Baseline in Cutaneous Atrophy Sign Score, Epidermal Thickening /Lichenification Sign Score and Abnormal Pigmentation Score Using Visual Analogue Scale (VAS) at the End of the Maintenance Phase and Follow-up Phase|Investigator evaluated and scored the signs of cutaneous atrophy (CA), epidermal thickening/lichenification (ET/L) and abnormal pigmentation (AP) using the Visual Analogue Scale (ranging from 0 to 10, higher values represent a worse outcome) based on their subjective judgment. The change from Baseline in each sign (Cutaneous atrophy, epidermal thickening / lichenification and abnormal pigmentation) score at the end of the Maintenance Phase and Follow-up Phase and is calculated as the score at the end of the Maintenance and Follow-up Phase minus the Baseline score. Baseline is defined as VAS score for each sign obtained at Visit 4 (end of Acute Phase). Summation of VAS scores for each sign (CA, ET/L and AP) was done to calculate the Total VAS score (ranging from 0 to 30, higher values represent a worse outcome) at the Maintenance and Follow-up phase of study. The missing value was imputed using last-observation-carry-forward (LOCF) method.|Baseline, Week 20 and Week 32|ITT Population||Scores on a scale||Standard Deviation|Mean
657739|NCT01915914|Secondary|Change From Baseline in Cutaneous Atrophy Sign Score, Epidermal Thickening /Lichenification Sign Score and Abnormal Pigmentation Score Using Visual Analogue Scale (VAS) at the End of the Acute Phase|Investigator evaluated and scored the signs of cutaneous atrophy (CA), epidermal thickening/lichenification (ET/L) and abnormal pigmentation (AP) using Visual Analogue Scale (ranging from 0 to 10, higher values represent a worse outcome) based on their subjective judgment. The change from Baseline in each signs (Cutaneous atrophy, epidermal thickening / lichenification and abnormal pigmentation) score at the end of the Acute Phase (Visit 4 [Week 0 or treatment success, depend on which time point comes first) ±2day]) and is calculated as the score at Visit 4 minus the Baseline score. Baseline is defined as the VAS score for each sign obtained before the first dose of study drug in the Acute Phase of the study (Visit 2). Summation of the VAS scores for each sign (CA, ET/L and AP) was done to calculate the Total VAS score (ranging from 0 to 30, higher values represent a worse outcome) at Visit 4 of the Acute Phase of the study.|From the start of treatment up to Visit 4 (Week 0) or treatment success (depends on which time point comes first)|Enrolled Population||Scores on a scale||Standard Deviation|Mean
657749|NCT01915914|Primary|Time to the First Relapse of AD During the Maintenance Phase|Time to the first relapse of AD is defined as the number of days from start of the FP treatment in Maintenance Phase until AD relapse. AD relapse is defined as participants with PSGA exacerbation score >=2 (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe) compared to PSGA score of treatment success during Acute Phase. Participants with treatment success are defined as participants with PSGA <=1; and the improvement >=2 compared to Baseline.|From the start of treatment up to Week 20 during the Maintenance Phase|ITT Population: all participants who were randomized into the Maintenance Phase. Only participants available at the specified time point were analyzed.||Days||95% Confidence Interval|Median
657740|NCT01915914|Secondary|Number of Participants With Post-study Assessment of Lotion Qualities (2) Using Questionnaire|"Participants from each group completed the post-study questionnaire to rate the qualities of the lotion as compared with other skin emollients used in the past based on their experience. Each participant was asked the following Questions (Q). Q 1: It leaves my skin feeling soft and smooth; Q 2: There is nothing left on my skin; Q 3: Does not feel greasy; Q 4: Disappears into my skin quickly after I put it on; Q 5: Easy to apply; Q 6: Fragrance-free; Q 7: Spreadability; Q 8: Lack of stickiness. Participants rated the qualities of the lotion based on a 5 point scale (5= “Strongly Agree”, 4= “Agree”, 3= “Neutral”, 2= “Disagree, 1= “Strongly Disagree” N/A=Does not apply to me). Participant's rating for each question were summarized."|At early withdrawal or end of the therapy visit (up to Week 32)|ITT Population||Participants|||Number
657741|NCT01915914|Secondary|Number of Participants With Post-study Assessment of Lotion Qualities (1) Using Questionnaire|"Participants from each group completed the post-study questionnaire to rate the qualities of the lotion as compared with other skin emollients used in the past based on their experience. Each participant was asked the following Questions (Q). Q 1: This product is easier to use than other skin emollients; Q 2: When I apply this product I am able to start my daily activities quicker than with other skin emollients; Q 3: This product leaves my skin feeling softer than other skin emollients; Q 4: I am able to apply this product to larger body surface areas than other skin emollients; Q 5: This product disappears into my skin quicker than when I apply other skin emollients. Participants rated the qualities of the lotion based on a 5 point scale (5= “Strongly Agree”, 4= “Agree”, 3= “Neutral”, 2= “Disagree, 1= “Strongly Disagree” N/A=Does not apply to me). Participant's rating for each question were summarized."|At early withdrawal or end of the therapy visit (up to Week 32)|Enrolled Population||Participants|||Number
657742|NCT01915914|Secondary|Number of Participants With Post-study Assessment of Skin Emollients Using Questionnaire|Participants from each group completed the post-study questionnaire to rate the skin emollients (gel, lotion, cream, ointment, solution and foam) used in the past based on their experience. Participants rated skin emollients on a 5-point scale (5= “liked the best”, 4= “second best”, 3= “third best”, 2= “fourth best, 1= “liked the least”, N/A=Does not apply to me).|At early withdrawal or end of the therapy visit (up to Week 32)|ITT Population||Participants|||Number
657743|NCT01915914|Secondary|Change From Baseline in QoL at the End of the Follow-up Phase|Infant's IDQOL and Children's CDLQI were used to evaluate quality of life for participants of age between 1 to 16 years. IDQOL and CDLQI questionnaires were designed for infants (below the age of 4 years) and children (age 4 to age 16) with AD, respectively. The IDQOL and CDLQI were calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score in each questionnaire, the more quality of life is impaired. The change from Baseline in QoL score is based on each questionnaire at the end of the Follow-up Phase and is calculated as the score at the end of the Follow-up Phase minus the Baseline score. Baseline is defined as QoL scores obtained at Visit 4 (end of Acute Phase). A QOL is equal to IDQOL if the age of a participant is < 4 years and it is equal to CDLQI if the age of a participant is between 4 and 16 years.|Baseline and Week 32|ITT Population||Scores on a scale||Standard Deviation|Mean
657744|NCT01915914|Secondary|Change From Baseline in Quality of Life (QoL) at the End of the Maintenance Phase|Infant's Dermatitis Quality of Life Index (IDQOL) and Children's Dermatology Life Quality Index (CDLQI) were used to evaluate quality of life for participants of age between 1 to 16 years. IDQOL and CDLQI questionnaires were designed for infants (below the age of 4 years) and children (age 4 to age 16) with atopic dermatitis, respectively. The IDQOL and CDLQI were calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score in each questionnaire, the more quality of life is impaired. The change from Baseline in the QoL score is based on each questionnaire at the end of the Maintenance Phase and is calculated as the score at the end of the Maintenance Phase minus the Baseline score. Baseline is defined as QoL scores obtained at Visit 4 (end of Acute Phase). A QOL is equal to IDQOL if the age of a participant is < 4 years and it is equal to CDLQI if the age of a participant is between 4 and 16 years.|Baseline and Week 20|ITT Population||Scores on a scale||Standard Deviation|Mean
657745|NCT01915914|Secondary|Number of Participants With “Treatment Success” During the Acute Phase|"The number of participants with treatment success” during the Acute Phase is presented. Participants with treatment success are defined as participants with PSGA <=1; and the improvement >=2 (the six-point scale of PSGA: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe) compared to Baseline in the Acute Phase of the study."|From the start of treatment up to Visit 4 (Week 0) or treatment success (depends on which time point comes first)|Enrolled Population: all participants who were enrolled into the Acute Phase of the study.||Participants|||Number
657746|NCT01915914|Secondary|Numbers of Recurrent Participants at the End of the Follow-up Phase (Week 32)|The number of participants with AD recurrent/relapse at the end of the Follow-up Phase is presented. AD relapse is defined as participants with PSGA exacerbation score >=2 (the six-point scale of PSGA: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe) compared to PSGA score of treatment success. Participants with treatment success is defined as participants with PSGA <=1; and the improvement >=2 compared to Baseline.|From Week 20 to Week 32|ITT Population||Participants|||Number
657747|NCT01915914|Secondary|Numbers of Recurrent Participants at the End of the Maintenance Phase (Week 20)|The number of participants with AD recurrent/relapse at the end of Maintenance Phase is presented. AD relapse is defined as participants with PSGA exacerbation score >=2 (the six-point scale of PSGA: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe) compared to PSGA score of treatment success. Participants with treatment success is defined as participants with PSGA <=1; and the improvement >=2 compared to Baseline.|From Week 0 (or treatment success, if earlier) to Week 20|ITT Population||Participants|||Number
657748|NCT01915914|Secondary|Median Time to the First Relapse of AD During the Maintenance Phase and Follow-up Phase|Median time to the first relapse of AD during the Maintenance Phase and Follow-up Phase is defined as the number of days from start of the FP treatment until AD relapse during the Maintenance Phase and Follow-up Phase. AD relapse is defined as participants with PSGA exacerbation score >=2 (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe) compared to PSGA score of treatment success during the Acute Phase.|From the start of treatment up to Week 32 during the Maintenance Phase and Follow-up Phase|ITT Population. Only participants avilable at the specified time point were analyzed.||Days||95% Confidence Interval|Median
657750|NCT01915849|Primary|Area Under the Postprandial Curve (AUC) for Rate of Appearance (Ra) of Exogenous Glucose|Glucose fluxes during a mixed meal were measured using a dual glucose tracer method and non-steady state Steele equations. The rate of appearance of meal (or exogenous) glucose in the blood (also referred to as intestinal glucose absorption or Ra meal) after a mixed meal following LIK066 administration on Days 1 and 4 was the primary PD assessment in this study.The postprandial AUC was calculated using the linear trapezoidal rule. The sample collected at 7 hours after the start of the infusion was treated as the pre-meal, 0 hour measurement for the AUC0-5 hr calculation.|Day 1 and Day 4 (pre-meal, every half hour till 5 hour on Day 1 and Day 4)|The pharmacodynamic (PD) analysis set included all patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data.||(umol/kg FFM/min)*hr||Standard Deviation|Mean
657751|NCT01915823|Other Pre-specified|Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ)|Change from baseline to Visit 4 in the ITT ( intent to treat) Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) in subjects equal to or greater than 6 years old and less than12 years old compared to placebo.Scored on a 0 to 7 scale with 0 being not troubled at all and 7 being extremely troublesome. The higher the difference the better the result.|day 1 to day 15 of treatment|||units on a scale||Standard Deviation|Mean
657752|NCT01915823|Secondary|Safety|"Subject-reported adverse experiences (incidence, type, and severity of adverse events)
Nasal Examinations
Vital signs assessments"|entire length of study (day 1 to day 22)|||occurance|||Number
657753|NCT01915823|Primary|Primary Efficacy|change from baseline in AM+PM rTNSS (reflective total nasal symptoms score): ITT( intent to treat population)change from baseline in 12-hour reflective total nasal symptom score (rTNSS) consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary for the entire 14 day study period.The measurement scale is 0 to 24 so that the higher the number the worse the symptom.A reduction in symptom severity score is indicated by a negative value.A greater negative value suggests improvement.|15 days of treatment|||units on a scale||Standard Deviation|Mean
657754|NCT01915732|Secondary|Number of Participants Who Had an ISGA Score of 0 or 1 at Week 12|The assessor evaluated the acne severity of the participants' face using the ISGA scale, ranging from 0 to 4: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than one small IL; 2=mild, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: up to many NILs and ILs, but no more than a few NLs. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data.|Week 12|PP Population||Participants|||Number
657755|NCT01915732|Secondary|Number of Participants Who Had an ISGA Score of 0 or 1 at Week 12|The assessor evaluated the acne severity of the participants' face using the ISGA scale, ranging from 0 to 4: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than one small IL; 2=mild, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: up to many NILs and ILs, but no more than a few NLs. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data.|Week 12|ITT Population||Participants|||Number
657756|NCT01915732|Secondary|Percent Change in Inflammatory, Non-inflammatory and Total Lesion Counts From Baseline to Week 12|The assessor performed a count of ILs (papules, pustules, nodules, and cysts), NILs (open and closed comedones) and total lesions (the sum of ILs and NILs)at each study visit. Lesion counts were confined to the face. Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline. Analysis of covariance (ANCOVA) model was used with terms for Baseline lesion count, treatment, and center. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data.|Baseline (Week 0) and Week 12|PP Population||Percent change in lesions||Standard Error|Least Squares Mean
657757|NCT01915732|Secondary|Percent Change in Inflammatory, Non-inflammatory and Total Lesion Counts From Baseline to Week 12|The assessor performed a count of ILs (papules, pustules, nodules, and cysts), NILs (open and closed comedones) and total lesions (the sum of ILs and NILs)at each study visit. Lesion counts were confined to the face. Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline. Analysis of covariance (ANCOVA) model was used with terms for Baseline lesion count, treatment, and center. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data.|Baseline (Week 0) and Week 12|ITT Population||Percent change in lesions||Standard Error|Least Squares Mean
657758|NCT01915732|Secondary|Absolute Change in Inflammatory Lesion Counts and Non-inflammatory Lesion Counts From Baseline to Week 12|The assessor performed a count of ILs (papules, pustules, nodules, and cysts), NILs (open and closed comedones at each study visit. Lesion counts were confined to the face. Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline. Analysis of covariance (ANCOVA) model was used with terms for Baseline lesion count, treatment, and center. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data.|Baseline (Week 0) and Week 12|PP Population||Lesions||Standard Error|Least Squares Mean
657759|NCT01915732|Secondary|Absolute Change in Inflammatory Lesion Counts and Non-inflammatory Lesion Counts From Baseline to Week 12|The assessor performed a count of ILs (papules, pustules, nodules, and cysts), NILs (open and closed comedones at each study visit. Lesion counts were confined to the face. Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline. Analysis of covariance (ANCOVA) model was used with terms for Baseline lesion count, treatment, and center. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data.|Baseline (Week 0) and Week 12|ITT Population||Lesions||Standard Error|Least Squares Mean
657760|NCT01915732|Primary|Number of Participants With an Improvement of 2 Grades in the Investigator Static Global Assessment (ISGA) Score From Baseline to Week 12|ISGA success is defined as the improvement of 2 grades or more in the participant's acne severity scale at Week 12. Acne severity of the participants' face was assessed by the assessor using the ISGA scale, ranging from 0 to 4: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than one small IL; 2=mild, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: up to many NILs and ILs, but no more than a few NLs. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data .|Baseline (Week 0) and Week 12|PP Population||Participants|||Number
657761|NCT01915732|Primary|Number of Participants With an Improvement of 2 Grades in the Investigator Static Global Assessment (ISGA) Score From Baseline to Week 12|ISGA success is defined as the improvement of 2 grades or more in the participant's acne severity scale at Week 12. Acne severity of the participants' face was assessed by the assessor using the ISGA scale, ranging from 0 to 4: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than one small IL; 2=mild, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: up to many NILs and ILs, but no more than a few NLs. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data.|Baseline (Week 0) and Week 12|ITT Population||Participants|||Number
657762|NCT01915732|Primary|Absolute Change in Total Lesion Count From Baseline to Week 12|The assessor performed a count of inflammatory lesions (IL) (papules, pustules, nodules, and cysts), non-inflammatory lesions (NIL) (open and closed comedones) and total lesions (the sum of IL and NIL) at each study visit. Lesion counts were confined to the face. Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline. Parameters were estimated using analysis of covariance (ANCOVA) with treatment, center, treatment-by-centre interaction and Baseline lesion count in the model. Missing values were imputed using the last observation carried forward (LOCF), i.e., the last available observation was used to estimate subsequent missing data.|Baseline (Week 0) and Week 12|Per-Protocol (PP) Population: all participants included in the ITT Population who did not have a noteworthy protocol deviation that influenced effect.||Change in lesion count||Standard Error|Least Squares Mean
657763|NCT01915732|Primary|Absolute Change in Total Lesion Count From Baseline to Week 12|The assessor performed a count of inflammatory lesions (IL) (papules, pustules, nodules, and cysts), non-inflammatory lesions (NIL) (open and closed comedones) and total lesions (the sum of IL and NIL) at each study visit. Lesion counts were confined to the face. Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline. Parameters were estimated using analysis of covariance (ANCOVA) with treatment, center, treatment-by-centre interaction and Baseline lesion count in the model. Missing values were imputed using the last observation carried forward (LOCF), i.e., the last available observation was used to estimate subsequent missing data.|Baseline (Week 0) and Week 12|Intent-to-Treat (ITT) Population: all participants who were randomized and received at least one dose of study medication.||Change in lesion count||Standard Error|Least Squares Mean
657764|NCT01915173|Secondary|GERD Health-Related Quality of Life at Follow-up|The GERD Health-Related Quality of Life (GERD-HRQL) scale is a validated instrument assessing GERD-specific health-related quality of life using 10 questions, each on a 0-5 point scale. Scale range is 0-50 with higher numbers signifying worse quality of life.|Two weeks|All enrolled study participants.||units on a scale||Standard Deviation|Mean
657765|NCT01915173|Secondary|Number of Subjects With a 50% or Greater Decrease in GERD Symptom Severity|Average daily GERD symptom severity during the last 7 days of the study was compared to average daily GERD symptom severity at baseline using daily study diary entries. GERD symptom severity for each day was based on the sum of scores assessing the severity of daytime heartburn, nighttime heartburn, and acid reflux each on a 0-4 point scale (none, mild, moderate, severe, very severe). Higher scores signify worse symptoms. The number of subjects with a 50% or greater decrease in GERD symptom severity from baseline to end of study in each group was calculated.|Second week of the trial compared to pre-trial baseline|All enrolled study participants.||participants|||Number
657766|NCT01915173|Primary|Safety - Number of Participants Experiencing a Serious Adverse Event|Serious adverse events (as defined by the FDA) are events that are potentially life-threatening or result in death, hospitalization, an emergency room visit, disability or permanent damage, a congenital abnormality, require intervention to prevent permanent impairment, or seriously jeopardizes a patient's health.|2 week follow-up|All enrolled study participants.||participants|||Number
657767|NCT01915108|Primary|Number of Patients With Adverse Events Following LMA Removal|All patients received a predetermined Ce of remifentanil by TCI according to their group assignments from 10 minutes before the end of surgery to LMA removal. Adverse events such as coughing, airway obstruction, breath-holding, desaturation, nausea and vomiting were evaluated from the end of surgery until arrival in the post-anesthetic care unit.|from the end of surgery until arrival in the post-anesthetic care unit, an expected average of 15 minutes.|||participants|||Number
657768|NCT01914757|Secondary|Patient and Clinician Assessment of Response to Treatment|CGIC (clinician global impression of change), and PGIC (patient global impression of change) are overall evaluation of response to treatment, conducted separately by investigator and patient using a 7-point rating scale, ranging from 1 (Very much Improved), to 7 (Very much Worse). This endpoint was added after the second protocol amendment, thus not all patients had data to be analyzed.|Immediately following the first administration of study drug through Study Week 56|Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS||Participants|||Number
657769|NCT01914757|Secondary|Number of Participants That Utilized Health Care Resources||Immediately following the first administration of study drug through Study Week 56|Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS||Participants|||Number
657770|NCT01914757|Secondary|Mean Productivity Loss Due to Asthma in Classroom|WPAI+CIQ (Work Productivity and Activity Impairment plus Classroom Impairment Questionnaire) contains 10 questions. Classroom productivity loss is derived by sum of percentage of missed classes due to asthma and product of percentage of actual hours attending classes times degree of asthma affecting classroom productivity. Percentage of missed classes due to asthma is calculated by number of hours missed classes due to asthma divided by total number of hours missed classes plus number of hours actually attending classes. This is only applicable for patients who took classes.|Immediately following the first administration of study drug through Study Week 56|Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS, who took classes||percent of productivity loss||Standard Deviation|Mean
657800|NCT01914666|Secondary|Change From Baseline in Roland Morris Disability Questionnaire (RMDQ-24) to Week 50|RMDQ-24 is a participant completed questionnaire and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the participant was instructed to put a mark next to each appropriate statement. The number of statements marked was summed by the clinician for a total score. The total score ranged from 0 (no disability) to 24 (severe disability).|Baseline, Week 50|FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) score. LOCF was used.||units on a scale||Standard Deviation|Mean
657771|NCT01914757|Secondary|Mean Work Productivity Loss Due to Asthma|WPAI+CIQ (Work Productivity and Activity Impairment plus Classroom Impairment Questionnaire) contains 10 questions. Work productivity loss is derived by sum of percentage of missed work due to asthma and product of percentage of actual working hours times degree of asthma affecting work productivity while working. Percentage of missed work due to asthma is calculated by number of hours missed work due to asthma divided by total number of hours missed work plus number of hours actually worked. This is only applicable to patients who were employed.|Immediately following the first administration of study drug through Study Week 56|Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS, who were employed||Percent of productivity loss||Standard Deviation|Mean
657772|NCT01914757|Secondary|Change From Baseline to Week 56 in EQ-5D-5L VAS|EQ-5D-5L VAS is to rate current health status on a scale of 0-100, with 0 being the worst imaginable health state.|Immediately following the first administration of study drug through Study Week 56|Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS||Scores on a scale||Standard Deviation|Mean
657773|NCT01914757|Secondary|Mean Change From Baseline to Week 56 in AQLQ(S)+12|AQLQ(S)+12 overall score is defined as the average of all 32 questions in the AQLQ(S)+12 questionnaire. AQLQ(S)+12 is a 7-point scale questionnaire, ranging from 7 (no impairment) to 1 (severe impairment). Total or domain score change of >=0.5 are considered clinically meaningful.|Immediately following the first administration of study drug through Study Week 56|Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS||Scores on a scale||Standard Deviation|Mean
657774|NCT01914757|Secondary|Extent of Exposure|Extent of exposure is defined as the duration of treatment in days|Immediately following the first administration of study drug through Study Week 56|Safety analysis set||Days||Standard Deviation|Mean
657775|NCT01914757|Secondary|Immunogenicity of Benralizumab|Anti-drug antibodies (ADA) responses at baseline and post baseline. Persistently positive is defined as positive at >=2 post-baseline assessments (with >=16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive is defined as having at least one post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive.|Pre-treatment until end of follow-up|Safety analysis set||Participants|||Number
657776|NCT01914757|Secondary|Pharmacokinetics of Benralizumab|Mean PK Concentration at each visit|Baseline, Week 4, Week 8, Week 16, Week 24, Week 32, Week 40, Week 48, Week 56, Week 60|PK analysis set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
657777|NCT01914757|Secondary|Annual Rate of Asthma Exacerbation Resulting Emergency Room Visits and Hospitalizations|Annual rate of asthma exacerbations that are associated with an emergency room visit or a hospitalization (adjudicated)|Immediately following the first administration of study drug through Study Week 56.|Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS||Events/year||95% Confidence Interval|Least Squares Mean
657778|NCT01914757|Secondary|Time to First Asthma Exacerbation||Immediately following the first administration of study drug through Study Week 56|Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS||Participants|||Number
657779|NCT01914757|Secondary|Number of Patients With >=1 Asthma Exacerbation||Immediately following the first administration of study drug through Study Week 56|Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS||Participants|||Number
657780|NCT01914757|Secondary|Mean Change From Baseline to Week 56 in ACQ-6 for Patients With Baseline Eosinophils <300/uL|ACQ-6 contains one bronchodilator question and 5 symptom questions. Questions are rated from 0 (totally controlled) to 6 (severely uncontrolled). Mean ACQ-6 score is the average of the responses. Mean scores of <=0.75 indicates well-controlled asthma, scores between 0.75 to <=1.5 indicate partly controlled asthma, and >1.5 indicates not well controlled asthma.|Immediately following the first administration of study drug through Study Week 56.|Full analysis set, Baseline eosinophils <300/uL, High-dose ICS||Scores on a scale||Standard Deviation|Mean
657781|NCT01914757|Secondary|Mean Change From Baseline to Week 56 in ACQ-6 for Patients With Baseline Eosinophils >=300/uL|ACQ-6 contains one bronchodilator question and 5 symptom questions. Questions are rated from 0 (totally controlled) to 6 (severely uncontrolled). Mean ACQ-6 score is the average of the responses. Mean scores of <=0.75 indicates well-controlled asthma, scores between 0.75 to <=1.5 indicate partly controlled asthma, and >1.5 indicates not well controlled asthma.|Immediately following the first administration of study drug through Study Week 56.|Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS||Scores on a scale||Standard Deviation|Mean
657782|NCT01914757|Secondary|Proportion of Nights With Awakening Due to Asthma|Change from Baseline to Week 56 on Proportion of Nights with awakening due to asthma|Immediately following the first administration of study drug through Study Week 56.|Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS||Proportion of nights||Standard Deviation|Mean
657783|NCT01914757|Secondary|Home Lung Function Assessments Based on PEF|Change from Baseline to Week 56 in Home lung function (morning and evening Peak expiratory flow [PEF])|Immediately following the first administration of study drug through Study Week 56.|Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS||L/min||Standard Deviation|Mean
657784|NCT01914757|Secondary|Change in Asthma Rescue Medication Use|Change from Baseline to Week 56 in number of Rescue medication use (puffs/day)|Immediately following the first administration of study drug through Study Week 56.|Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS||Puffs per day||Standard Deviation|Mean
657785|NCT01914757|Secondary|Mean Change From Baseline to Week 56 Asthma Symptoms Score for Patients With Baseline Eosinophils <300/uL|Asthma symptoms during night time and daytime are recorded by the patient each morning and evening in the asthma daily diary. Symptom score values are from 0 (No asthma symptom) to 3 (unable to sleep because of asthma). Baseline is defined as the average of data collected from the evening of study day -10 to the morning of study day 1. Each timepoint is calculated as bi-weekly means based on daily diary data. If more than 50% of scores are missing in a 14 day period then this is considered as missing. Symptom score lower is better.|Immediately following the first administration of study drug through Study Week 56.|Full analysis set, Baseline eosinophils <300/uL, High-dose ICS||Scores on a scale||Standard Deviation|Mean
657801|NCT01914666|Secondary|Change From Baseline in Clinical Global Impression of Severity (CGI-Severity) to Week 50|CGI-S measures severity of illness at the time of assessment compared with start of treatment with scores ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).|Baseline, Week 50|FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) score. LOCF was used.||units on a scale||Standard Deviation|Mean
657786|NCT01914757|Secondary|Mean Change From Baseline to Week 56 Asthma Symptoms Score for Patients With Baseline Eosinophils >=300/uL|Asthma symptoms during night time and daytime are recorded by the patient each morning and evening in the asthma daily diary. Symptom score values are from 0 (No asthma symptom) to 3 (unable to sleep because of asthma). Baseline is defined as the average of data collected from the evening of study day -10 to the morning of study day 1. Each timepoint is calculated as bi-weekly means based on daily diary data. If more than 50% of scores are missing in a 14 day period then this is considered as missing. Symptom score lower is better.|Immediately following the first administration of study drug through Study Week 56.|Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS||Scores on a scale||Standard Deviation|Mean
657787|NCT01914757|Secondary|Mean Change From Baseline to Week 56 in Pre-bronchodilator FEV1 (L) Value for Patients With Baseline Eosinophils <300/uL||Immediately following the first administration of study drug through Study Week 56.|Full analysis set, Baseline eosinophils <300/uL, High-dose ICS||Liter||Standard Deviation|Mean
657788|NCT01914757|Secondary|Mean Change From Baseline to Week 56 in Pre-bronchodilator FEV1 (L) Value for Patients With Baseline Eosinophils >=300/uL||Immediately following the first administration of study drug through Study Week 56.|Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS||Liter||Standard Deviation|Mean
657789|NCT01914757|Secondary|Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Patients With Baseline Eosinophils <300/uL|The annual exacerbation rate is based on unadjudicated annual exacerbation rate reported by the investigator in the eCRF.|Immediately following the first administration of study drug through Study Week 56.|Full analysis set, Baseline eosinophils <300/uL, High-dose ICS.||Events/year||95% Confidence Interval|Least Squares Mean
657790|NCT01914757|Primary|Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Patients With Baseline Eosinophils >=300/uL|The annual exacerbation rate is based on unadjudicated annual exacerbation rate reported by the investigator in the eCRF.|Immediately following the first administration of study drug through Study Week 56.|Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS.||Events/year||95% Confidence Interval|Least Squares Mean
657791|NCT01914679|Other Pre-specified|fMRI Measures of Network Connectivity|Subjects will undergo a neuroimaging scan at Baseline (week 1), week 6, and week 18. The scan will measure network connectivity during stimuli.|Baseline (week 1), week 6, and week 18||||||
657792|NCT01914679|Other Pre-specified|Investigate Changes in Neurocognitive Functioning Using the MASQ and MCS Assessments.|The MASQ and MCS questionnaires will be administered at Baseline (week 1), week 6, week 10, week 14, week 18 and week 21.|Baseline and up to 21 weeks||||||
657793|NCT01914679|Other Pre-specified|Change in Network Connectivity as Measured by EEG|EEGs will be measured at the baseline, week 4, week 18 and week 21 visits.|Baseline (week 1), week 6, week 18 and week 21||||||
657794|NCT01914679|Primary|Change in Patient 24-hour Recall Average Pain Intensity|The units of measure represent self-reported average pain over the last 24 hours on a 0-100 pain rating scale where 0 is no pain and 100 is the worst pain imaginable.|Assessed at Baseline (Week 1), Post-Sham (Week 5), Mid-Treatment (Week 10), Mid-Treatment (Week 14), Post-Treatment (Week 18)|One participant missing from analysis at Week 14/Mid-Treatment/Visit 27 due to missed visit.||units on a scale||Standard Deviation|Mean
657795|NCT01914666|Secondary|Number of Participants With Fall Events From Fall Questionnaire|Participants evaluated their experience with and details of falls which were recorded. Percentage = (number of participants with fall events) /(total in treatment group) * 100.|Week 53|All the enrolled participants who received at least 1 dose of study drug.||participants|||Number
657796|NCT01914666|Secondary|Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) to Week 52|"C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior is defined as a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation is defined as a yes answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation."|Baseline, Week 53|All randomized participants who received at least 1 dose of study drug, responded no at baseline to the suicide related questionnaire and had data at post-treatment for each question.LOCF was used.||participants|||Number
657797|NCT01914666|Secondary|Change From Baseline in Beck Depression Inventory-II (BDI-II) to Week 50|BDI-II is a 21-item, participant-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to symptoms of depression were scored on a 4-point scale ranging from 0 to 3 and was summed to give a single score. A total score of 0-13 was considered minimal range, 14-19 was mild, 20-28 was moderate, and 29-63 was severe.|Baseline, Week 50|FAS: All randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-dose BPI pain severity (average pain) scores. LOCF was used.||units on a scale||Standard Deviation|Mean
657798|NCT01914666|Secondary|Change From Baseline in European Quality of Life Questionnaire-5 Dimension (EQ-5D) to Week 50|The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a three level scale (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the Japan population-based algorithm ranging from -0.111 to 1.0, with higher scores indicating better quality of life.|Baseline, Week 50|FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) scores. LOCF was used.||units on a scale||Standard Deviation|Mean
657799|NCT01914666|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) to Week 50|SF-36 Health Status Survey is a generic, health-related scale assessing participant's quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning.|Baseline, Week 50|FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) score. LOCF was used.||units on a scale||Standard Deviation|Mean
657945|NCT01911273|Secondary|Maximum Serum Concentration (Cmax)||1 hour (after start of infusion) on Day1 of Cycles 1, 2, 4, 6, and 8|The pharmacokinetic (PK) concentration set consisted of all participants who were treated and had at least one concentration on at least 1 day of PK assessment.||microgram per milliliter (mcg/mL)||Standard Error|Geometric Mean
657802|NCT01914666|Secondary|Patient Global Impression of Improvement (PGI-Improvement) to Week 50|PGI-I measures a participant's perception of improvement at the time of assessment compared with the start of treatment. Score ranges from 1 (very much better) to 7 (very much worse).|Week 50|FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) scores. LOCF was used.||units on a scale||Standard Deviation|Mean
657803|NCT01914666|Secondary|Change From Baseline in Brief Pain Inventory (BPI) Pain Severity Item and Interference Item to Week 50|A self-reported scale measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items.|Baseline, Week 50|(FAS): All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) scores. The last observation carried forward (LOCF) was used.||units on a scale||Standard Deviation|Mean
657804|NCT01914666|Primary|Number of Participants With Drug Related Adverse Events (AEs) or Any Serious AE’s|A summary of serious AEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.|Week 53|All the enrolled participants who received at least 1 dose of study drug.||participants|||Number
657805|NCT01914003|Primary|Prevalence of CSID Genetic Variants|Prevalence of CSID genetic variants in subjects 18 years of age or younger with a primary symptom of chronic idiopathic diarrhea or chronic abdominal pain without constipation.|1 year|||Participants|||Number
657806|NCT01913795|Other Pre-specified|Asthma Control||12 months||||||
657807|NCT01913795|Other Pre-specified|Rescue Medication||12 months||||||
657808|NCT01913795|Other Pre-specified|FeNO||12 months||||||
657809|NCT01913795|Secondary|Lung Function|peak expiratory flow (PEF)|measured at baseline and months 6 and 12|||Liters/second||Standard Error|Mean
657810|NCT01913795|Primary|Asthma Symptoms|number of days of wheezing/cough|over a two week period at Baseline and Months 3, 6, 9 and 12|||Days||Full Range|Mean
657811|NCT01913535|Secondary|Number of Participants With Clinically Significant Abnormal Labs|Total number of participants with clinically significant abnormal labs|72 hours after treatment initiation|In the sequential parallel comparison design (SPCD) analyses through 72 hours, placebo non-responder data is included from phase 2 and is pooled with phase 1 data. All placebo participants from phase 1 were non-responders based on HAM-D-6 reduction and MADRS criteria.||Participants|||Count of Participants
657812|NCT01913535|Secondary|Number of Participants With Clinically Significant Abnormal ECG|Number of Participants with clinically significant abnormal electrocardiogram (ECG)|72 hours after treatment initiation|In the sequential parallel comparison design (SPCD) analyses through 72 hours, placebo non-responder data is included from phase 2 and is pooled with phase 1 data. All placebo participants from phase 1 were non-responders based on HAM-D-6 reduction and MADRS criteria.||Participants|||Count of Participants
657813|NCT01913535|Secondary|Change in the Columbia-Suicide Severity Rating Scale (C-SSRS)|The C-SSRS is a low-burden measure of the spectrum of suicidal ideation and behavior. It is a clinical interview providing a summary of both ideation and behavior that can be administered during any evaluation or risk assessment to identify the level and type of suicidality present. The C-SSRS will be performed to assess suicidal ideation and behavior. It contains a 5-item rating scale for suicidal ideation and a 7-item rating scale for suicidal behavior. Higher total scores indicate higher severity. Each item is coded 1=yes, 0=no, so a total score of 0 on each scale means that a no response was entered for each of the 5 suicidal ideation and for each of the 7 suicidal behavior questions, i.e., 0=lowest severity score. Total suicidal ideation score ranges from 0 (least severe) to 5 (most severe). Total suicidal behavior score ranges from 0 (least severe) to 7 (most severe).|Baseline and 72 hours after initiating treatment|In the sequential parallel comparison design (SPCD) analyses through 72 hours, placebo non-responder data is included from phase 2 and is pooled with phase 1 data. All placebo participants from phase 1 were non-responders based on HAM-D-6 reduction and MADRS criteria. 1 CERC-501 pt and 3 placebo pts are missing data on 72-hr change values.||units on a scale||Full Range|Median
657814|NCT01913535|Secondary|Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Satisfaction With Participation in Social Roles and Discretionary Activities|"These are two well-validated 7-item self-rating scales that measure social health. A higher score represents higher satisfaction on each scale. The scales are rated based on the past 24 hours. Each item is rated 1-5 (1=Not at all, 2=A little bit, 3=Somewhat, 4=Quite a bit, 5=Very much). Each 7-item subscale score is the sum of each of the 7 items and ranges from 7-35.
To better estimate the baseline, we did not use simply the cross-sectional assessment at baseline, but we estimated the average during the screening period as the true baseline."|Baseline and 72 hours and 20 days after initiating treatment|In the sequential parallel comparison design (SPCD) analyses through 72 hours, placebo non-responder data is included from phase 2 and is pooled with phase 1 data. All placebo participants from phase 1 were non-responders based on HAM-D-6 and MADRS criteria.The 20-day follow-up analyses only use drug-drug (either dose) and placebo-placebo arms.||units on a scale||Full Range|Median
657815|NCT01913535|Secondary|Change in Positive Affect Scale (PAS)|"This is a validated, self-rated measure of positive affect uses 5-point scales (1 = very slightly/not at all to 5 = extremely). Higher scores represent higher levels of positive affect. The scale is rated based on the past 24 hours. The total score is the sum of 10 items, for a range of 10-50.
To better estimate the baseline, we did not use simply the cross-sectional assessment at baseline, but we estimated the average during the screening period as the true baseline."|Baseline and 72 hours and 20 days after initiating treatment|In the sequential parallel comparison design (SPCD) analyses through 72 hrs, placebo non-responder data is included from phase 2 and is pooled with phase 1. All phase 1 placebo participants were non-responders based on HAM-D-6 and MADRS criteria.The 20-day analyses only use drug-drug (either dose) and placebo-placebo arms. 1 pt missing PAS data.||units on a scale||Full Range|Median
657870|NCT01912404|Primary|Survival||28 days|The study was prematurely stopped due to emerging data from another study showing ~10 to 12-fold higher exposures in patients with severe hepatic impairment compared to those with normal liver function. Since subjects with alcoholic hepatitis would likely have severe hepatic impairment, the study was stopped and survival data was not collected.|||||
657816|NCT01913535|Secondary|Change in Perceived Stress Scale (PSS)|"This is a 10-item, validated, self-rated measure of perceived stress, that is of the degree to which the subjects perceives things to be stressful and overwhelming. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress. This scale is rated based on the past 24 hours.
To better estimate the baseline, we did not use simply the cross-sectional assessment at baseline, but we estimated the average during the screening period as the true baseline."|Baseline and 72 hours and 20 days after treatment initiation|In the sequential parallel comparison design (SPCD) analyses through 72 hrs, placebo non-responders are included from phase 2 and are pooled with phase 1. All placebo participants from phase 1 were non-responders based on HAM-D-6 and MADRS criteria. 2 pts missing 72-hr PSS values. The 20-day analyses only use drug-drug and placebo-placebo arms.||units on a scale||Full Range|Median
657817|NCT01913535|Secondary|Change in Symptoms of Depression Questionnaire (SDQ)|"This validated self-rating instrument has 44 items on a scale of 1-6, measuring multiple depressive symptom domains. Each item is rated based on a subject's perception of what is normal for the individual (score = 2), what is better than normal (score = 1), and what is worse than normal (scores = 3–6). This scale is rated based on the past 24 hours. A total score is calculated by summing the 44 item scores, for a range of 0-264.
To better estimate the baseline, we did not use simply the cross-sectional assessment at baseline, but we estimated the average during the screening period as the true baseline."|Baseline and 72 hours and 20 days after initiating treatment|In the sequential parallel comparison design (SPCD) analyses through 72 hours, placebo non-responder data is included from phase 2 and is pooled with phase 1 data. All placebo participants from phase 1 were non-responders based on HAM-D-6 and MADRS criteria. The 20-day follow-up analyses only use drug-drug (either dose) and placebo-placebo arms.||units on a scale||Full Range|Median
657818|NCT01913535|Secondary|Clinical Global Impression-Improvement (CGI-I)|The CGI-I scale was administered by clinicians to measure improvement in depressive severity (CGI-I). Each item is rated on a seven-point scale (1=very much improved to 7=very much worse), so a higher total score indicates less improvement in depressive severity. Improvement is assessed based on the last 24 hours.|72 hours and 20 days after initiating treatment|In the sequential parallel comparison design (SPCD) analyses through 72 hours, placebo non-responder data is included from phase 2 and is pooled with phase 1 data. All placebo participants from phase 1 were non-responders based on HAM-D-6 and MADRS criteria.The 20-day follow-up analyses only use drug-drug (either dose) and placebo-placebo arms.||units on a scale||Full Range|Median
657819|NCT01913535|Secondary|Change in Clinical Global Impression -Severity (CGI-S)|"The CGI-S scale was administered by clinicians to measure depressive severity (CGI-S). Each item is rated on a seven-point scale (1=normal to 7=among the most severe), so a higher total score indicates greater depressive severity. Severity is assessed based on the last 24 hours.
To better estimate the baseline, we did not use simply the cross-sectional assessment at baseline, but we estimated the average during the screening period as the true baseline."|Baseline and 72 hours and 20 days after initiating treatment|In the sequential parallel comparison design (SPCD) analyses through 72 hours, placebo non-responder data is included from phase 2 and is pooled with phase 1 data. All placebo participants from phase 1 were non-responders based on HAM-D-6 and MADRS criteria. The 20-day follow-up analyses only use drug-drug (either dose) and placebo-placebo arms.||units on a scale||Full Range|Median
657820|NCT01913535|Secondary|Change in Montgomery-Asberg Depression Rating Scale (MADRS)|"The 10-item Montgomery-Asberg Depression Rating Scale (MADRS), which measures depression severity (in past 3 days), was completed by clinicians using an MGH structured interview. Each item is measured on a scale from 0 to 6, and the items are summed to find the total score. The total minimum score is 0 units on a scale and the total maximum score is 60 units on a scale, where higher scores indicate more severe depression.
To better estimate the baseline, we did not use simply the cross-sectional assessment at baseline, but we estimated the average during the screening period as the true baseline."|Baseline and 72 hours and 20 days after initiating treatment|In the sequential parallel comparison design (SPCD) analyses through 72 hours, placebo non-responder data is included from phase 2 and is pooled with phase 1 data. All placebo participants from phase 1 were non-responders based on HAM-D-6 and MADRS criteria. The 20-day follow-up analyses only use drug-drug (either dose) and placebo-placebo arms.||units on a scale||Full Range|Median
657821|NCT01913535|Secondary|Number of Participants With Response on Hamilton Rating Scale for Depression - 6 Items (HAM-D-6)|"Compare response rates at 72 hours for of patients treated with either dose (10 mg/day or 20 mg/day) of CERC-501 to those assigned to placebo therapy, using the Sequential Parallel Comparison Design (SPCD), with response defined as a 50% or greater reduction from baseline to Day 3 on the HAM-D-6 total score).
To better estimate the baseline, we did not use simply the cross-sectional assessment at baseline, but we estimated the average during the screening period as the true baseline.
The HAM-D-6 instrument is completed with a structured interview guide by the clinician based on his/her assessment of the patient's symptoms. This structured interview has been validated for use with time frames shorter than one week. Scale items are assessed based on symptoms within the past 24 hours. A higher score indicates more depression symptoms."|72 hours after treatment initiation|In the sequential parallel comparison design (SPCD) analyses through 72 hours, placebo non-responder data is included from phase 2 and is pooled with phase 1 data. All placebo participants from phase 1 were non-responders based on HAM-D-6 reduction and MADRS criteria.||Participants|||Count of Participants
657822|NCT01913535|Secondary|Change in Hamilton Rating Scale for Depression - 6 Items (HAM-D-6), Day 20|"This instrument is completed with a structured interview guide by the clinician based on his/her assessment of the patient's symptoms. This structured interview has been validated for use with time frames shorter than one week. Scale items are assessed based on symptoms within the past 24 hours. A higher score indicates more depression symptoms. Total scores range from 0 (normal) to 22 (severe).
To better estimate the baseline, we did not use simply the cross-sectional assessment at baseline, but we estimated the average during the screening period as the true baseline."|Baseline and 20 days after initiating treatment|The 20-day follow-up analyses only use drug-drug (either dose) and placebo-placebo arms. 2 participants were in low dose drug-drug arm, 2 participants were in high dose drug-drug arm, and 1 participant was in the placebo-placebo arm. One drug-drug pt missing day 20 data.||units on a scale||Full Range|Median
659069|NCT01888900|Secondary|Extended Rapid Virological Responder|extended rapid virological response (HCV RNA <LLOQ Target not Detected at both weeks 4 and 12)|Both weeks 4 and 12 post treatment|||Participants|||Count of Participants
657823|NCT01913535|Primary|Change in Hamilton Rating Scale for Depression - 6 Items (HAM-D-6)|"This instrument is completed with a structured interview guide by the clinician based on his/her assessment of the patient's symptoms. This structured interview has been validated for use with time frames shorter than one week. Scale items are assessed based on symptoms within the past 24 hours. A higher score indicates more depression symptoms. Total scores range from 0 (normal) to 22 (severe).
To better estimate the baseline, we did not use simply the cross-sectional assessment at baseline, but we estimated the average during the screening period as the true baseline."|Baseline and 72 hours after initiating treatment|In the sequential parallel comparison design (SPCD) analyses through 72 hours, placebo non-responder data is included from phase 2 and is pooled with phase 1 data. All placebo participants from phase 1 were non-responders based on HAM-D-6 reduction and MADRS criteria.||units on a scale||Full Range|Median
657824|NCT01913483|Secondary|Participants With MI, Stroke/TIA, URV, Death, or Minor Bleeding Up to Day 30|"Outcome assessments at Day 30 include NACE, Major Adverse Clinical Events (MACE=death, MI, stroke/TIA, amputation, or URV), and bleeding defined as BARC ≥2, as adjudicated by the CEC.
In addition to Type 3(a-c), 4, and 5, BARC ≥2 also includes Type 2 bleeding, which is any overt, actionable sign of hemorrhage (more bleeding than would be expected for a clinical circumstance, including bleeding found by imaging alone) that does not fit the criteria for Type 3, 4, or 5, but does meet at least one of the following criteria of: requiring nonsurgical, medical intervention by a health-care professional; leading to hospitalization or increased level of care; prompting evaluation."|Study drug initiation (Day 1) up to 30 days|mITT Population: Participants who were randomized into the trial, received at least one dose of study drug, and underwent the index PEI procedure.||participants|||Number
657825|NCT01913483|Secondary|Participants With Myocardial Infarction (MI), Stroke/Transient Ischemic Attack (TIA), Unplanned Repeat Revascularization (URV), Death, and Minor Bleeding Up to 48 h Post Study Drug Administration|"Outcome assessments at 48 h post study drug initiation include bleeding events defined as BARC Type 2 or greater (BARC ≥2), bleeding events defined as thrombolysis in myocardial infarction (TIMI) major and TIMI minor, and net adverse clinical events (NACE) as adjudicated by the CEC (NACE=death, MI, stroke/TIA, amputations, URV, or bleeding events defined as BARC ≥3).
In addition to Type 3(a-c), 4, and 5, BARC ≥2 also includes Type 2 bleeding, which is any overt, actionable sign of hemorrhage (more bleeding than would be expected for a clinical circumstance, including bleeding found by imaging alone) that does not fit the criteria for Type 3, 4, or 5, but does meet at least one of the following criteria of: requiring nonsurgical, medical intervention by a health-care professional; leading to hospitalization or increased level of care; prompting evaluation."|Study drug administration (Day 1) up to 48 h post study drug initiation or at hospital discharge, whichever occurs first|mITT Population: Participants who were randomized into the trial, received at least one dose of study drug, and underwent the index PEI procedure.||participants|||Number
657826|NCT01913483|Primary|Participants With Bleeding Academic Research Consortium Type 3 or Greater (BARC ≥3) Events Up to 48 h or at Hospital Discharge, As Adjudicated by the Independent Clinical Events Committee (CEC)|"BARC ≥3 includes:
Type 3a-3c: clinical, laboratory, and/or imaging evidence of bleeding, which includes any transfusion with overt bleeding, bleeds that result in surgical intervention or administration of IV vasoactive drugs, overt bleeds with a hemoglobin drop greater than or equal to 3 grams (g)/deciliters (dL) to greater than or equal to 5 g/dL, cardiac tamponade caused by bleeding, intracranial hemorrhage, and intraocular bleeds that compromise vision.
Type 4: (Coronary Artery Bypass Grafting-related Bleeding) includes perioperative intracranial bleeding within 48 h, bleeds that result in reoperation following closure of sternotomy for the purpose of controlling bleeding, bleeds that result in treatment with transfusion of ≥5 U of whole blood or packed red blood cells within a 48-h period; and chest tube output ≥2 liters within a 24-h period.
Type 5: fatal bleeding that directly results in death that is either clinically suspicious or is confirmed as the cause of death."|Study drug administration (Day 1) up to 48 h post study drug initiation or at hospital discharge, whichever occurs first|mITT Population: Participants who were randomized into the trial, received at least one dose of study drug, and underwent the index PEI procedure.||percentage of participants|||Number
657827|NCT01913470|Other Pre-specified|Change in Aspartate Aminotransferase (AST) From Baseline to End of Treatment|The normal range for AST in children is 0 - 60 IU/L. AST can respond rapidly to treatment so decreases between Baseline and subsequent measurements indicate positive effects of treatment.|Baseline, Week 8, Week 14, and Week 22|In this blinded, crossover treatment, study participants received losartan or a placebo for 8 weeks, then completed a 6 week washout period before crossing over to the other treatment for 8 weeks. The placebo results for four participants in the losartan followed by placebo arm were not usable due to carry over effects from the active treatment.||IU/L||Standard Deviation|Mean
657828|NCT01913470|Secondary|Changes in Plasminogen Activator Inhibitor-1 (PAI-1) Concentrations Between Baseline and End of Treatment|PAI-1 is an acute-phase protein that is associated with both injury and inflammation, and has been found to be elevated in adolescents with significant hepatic steatosis. The reference range for PAI-1 in fasting adults is 3-72 ng/mL|Baseline, Week 8, Week 14, Week 22|The placebo results for four participants in the losartan followed by placebo arm were not usable due to carry over effects from the active treatment. One additional participant is missing PAI-1 data from the placebo phase of the study.||ng/mL||Standard Deviation|Mean
657829|NCT01913470|Secondary|Changes in Homeostasis Model of Assessment - Insulin Resistance (HOMA-IR) Between Baseline and End of Treatment (8 Weeks of Treatment)|Homeostasis Model of Assessment - Insulin Resistance (HOMA-IR) is an equation which indicates the degree of insulin resistance, where higher scores equate to greater insulin resistance. HOMA-IR is calculated as fasting glucose (mg/dl) × insulin (mU/L)/405. A HOMA-IR value >2.0 in prepubertal children and >2.6 in pubertal children, may be considered a warning sign for pediatricians to further investigate insulin resistance.|Baseline (Week 0 and 14), End of Treatment (Week 8 and 22)|The placebo results for four participants in the losartan followed by placebo arm were not usable due to carry over effects from the active treatment. An additional participant is missing HOMA-IR data from the placebo phase of the study.||units on a scale||Standard Deviation|Mean
657898|NCT01911793|Secondary|Time to Flatus (Passing Gas Into Stoma Bag)|# of hours after surgery at which point first passage of flatus (gas) into stoma bag|during 30 day postoperative period|Data were not collected and no data was analyzed study was terminated due to issues with study enrollment and study administrative coverage.|||||
659070|NCT01888900|Secondary|Rates of Rapid Virological Responder|rapid virological response (HCV RNA <LLOQ Target not Detected) at week 4|Week 4 post treatment|||Participants|||Count of Participants
657830|NCT01913470|Secondary|Change in Fatty Acid Levels From Baseline to End of Treatment (8 Weeks of Treatment)|In human studies, losartan has been shown to decrease serum free fatty acids, thus any decrease in this measurement indicates a positive response to losartan.|Baseline (Week 0 and 14), End of Treatment (Week 8 and 22)|The placebo results for four participants in the losartan followed by placebo arm were not usable due to carry over effects from the active treatment. One participant is missing the endpoint measurement for free fatty acid levels, following the 8 week losartan treatment phase.||mEq/L||Standard Deviation|Mean
657831|NCT01913470|Secondary|Change in Triglyceride Levels From Baseline to End of Treatment (8 Weeks of Treatment)|For children aged 10 to 19, triglyceride levels of less than 90 is considered acceptable, 90 to 129 is borderline high, and greater than or equal to 130 and over is high.|Baseline (Week 0 and 14), End of treatment (Week 8 and 22)|The placebo results for four participants in the losartan followed by placebo arm were not usable due to carry over effects from the active treatment. One participant is missing data for the endpoint measurement of triglyceride levels, following 8 weeks of losartan treatment.||mg/dL||Standard Deviation|Mean
657832|NCT01913470|Secondary|Change in Cholesterol Levels From Baseline to End of Treatment (8 Weeks of Treatment)|For children, a cholesterol level of less than 170 is considered acceptable, 170-199 is borderline high, and 200 and over is high.|Baseline (Week 0 and 14), End of treatment (Week 8 and 22)|The placebo results for four participants in the losartan followed by placebo arm were not usable due to carry over effects from the active treatment. One additional participant in each treatment group is missing the end of treatment cholesterol level measurement.||mg/dL||Standard Deviation|Mean
657833|NCT01913470|Primary|Change in Alanine Aminotransferase (ALT) From Baseline to End of Treatment (8 Weeks of Treatment)|The principal objective of this blinded, placebo controlled, crossover pilot study is to evaluate whether 8 weeks of losartan in children with nonalcoholic steatohepatitis (NASH) will decrease inflammation as measured by ALT.|Baseline (Weeks 0 and 14), Endpoint (Weeks 8 and 22)|In this blinded, crossover treatment, study participants received losartan or a placebo for 8 weeks, then completed a 6 week washout period before crossing over to the other treatment for 8 weeks. The placebo results for four participants in the losartan followed by placebo arm were not usable due to carry over effects from the active treatment.||U/L||Standard Deviation|Mean
657834|NCT01913041|Primary|The Incidence of Perioperative Hypothermia|Hypothermia incidence is defined as the percentage of the participants who occured hypothermia(Core temperature <36℃) accounts for the total amount of participants.|Perioperative period started from anesthesia induction to surgery ended|Actually 869 patients are enrolled, among which 39 patients were eliminated for the reasons operation cancelled temporarily or violate the eligible criteria, so 830 participants for analysis was determined to be analyzed per protocol in the end.||Percentage of hypothermia participants|||Number
657835|NCT01912781|Primary|Film Deposit Area Covered|Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. Values were reported as a percentage of lens area covered. One eye (study eye) contributed to the analysis.|Day 7, Day 30, Day 60, Day 90|This analysis population includes all randomized subjects. Here, “n” is the total number of subjects with film deposits in each treatment group, respectively, by visit.||percentage of lens area||Standard Deviation|Mean
657836|NCT01912781|Primary|Crystalline Deposit Area Covered|Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. Values were reported as a percentage of lens area covered. One eye (study eye) contributed to the analysis.|Day 7, Day 30, Day 60, Day 90|This analysis population includes all randomized subjects. Here, “n” is the total number of subjects with crystalline deposits in each treatment group, respectively, by visit.||percentage of lens area||Standard Deviation|Mean
657837|NCT01912781|Primary|"Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling."|Product handling was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects.|Day 7, Day 30, Day 60, Day 90|This analysis population includes all subjects with data at visit.||percentage of subjects|||Number
657838|NCT01912781|Primary|"Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear."|Clear vision was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects.|Day 7, Day 30, Day 60, Day 90|This analysis population includes all subjects with data at visit.||percentage of subjects|||Number
657839|NCT01912781|Primary|"Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day."|Lens comfort was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects.|Day 7, Day 30, Day 60, Day 90|This analysis population includes all subjects with data at visit.||percentage of subjects|||Number
657840|NCT01912781|Primary|Number of Unscheduled Lens Replacements by Reason|No lens replacements were planned during the study. Lenses could be replaced as needed due to loss, damage, or as deemed necessary by the Investigator. If it became necessary to replace a lens, the subject was examined at an unscheduled visit. The counts in the table represent the total number of unscheduled lenses replaced by reason for any eye, any subject.|Up to Day 90|This analysis population includes all randomized subjects.||lenses|||Number
657841|NCT01912781|Primary|Average Lens Wear Time|Subject recorded a response to the question, “Averaging over the last 3 days, how many hours per day did you wear your contact lenses?” Lens wear time was measured in hours.|Day 7, Day 30, Day 60, Day 90|This analysis population includes all subjects with data at visit.||Hours||Standard Deviation|Mean
657899|NCT01911793|Primary|Tolerating Low Residue Diet|% of patients tolerating a low residue diet on postoperative day 3 will be assessed|by postoperative day 3( 3rd day after surgery)|Data were not collected and no data was analyzed study was terminated due to issues with study enrollment and study administrative coverage.|||||
657842|NCT01912781|Primary|Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change|Distance VA was assessed for each eye individually while reading a chart distant to the participant in dimmed room illumination. VA was measured using a Snellen chart, with 20/20 Snellen acuity considered normal distance-eyesight. A line increase indicates an improvement in VA. One eye (study eye) contributed to the analysis.|Baseline (Day 0), Day 7, Day 30, Day 60, Day 90|This analysis population includes all subjects with data at visit.||percentage of subjects|||Number
657843|NCT01912781|Primary|Average Residual Lens Lysozyme|Worn study lenses were removed and analyzed by high performance liquid chromatography (HPLC) for residual lens lysozyme (protein). Values reported as lower than the limit of quantitation or none detected were imputed as 0.5 μg or 0 μg, respectively. A lower value indicates less lysozyme deposition. One eye (study eye) contributed to the analysis.|Day 90/Early Exit|This analysis population includes all randomized subjects.||micrograms per lens||Standard Deviation|Mean
657844|NCT01912781|Primary|Percentage of Subjects With Film Deposits by Type|Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered: Type II = films or deposits visible only under special conditions, such as special illumination using an eyepiece of 7-10 times magnification, Type III = films or deposits readily visible on a dry lens under room lighting, with unaided eye, and Type IV = films or deposits obvious under room lighting, with unaided eye, when the lens is wet or dry. One eye (study eye) contributed to the analysis.|Day 7, Day 30, Day 60, Day 90|This analysis population includes all randomized subjects. Here, “n” is the total number of subjects with film deposits in each treatment group, respectively, by visit.||percentage of subjects|||Number
657845|NCT01912781|Primary|Percentage of Subjects With Crystalline Deposits by Type|Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered: Type II = films or deposits visible only under special conditions, such as special illumination using an eyepiece of 7-10 times magnification, Type III = films or deposits readily visible on a dry lens under room lighting, with unaided eye, and Type IV = films or deposits obvious under room lighting, with unaided eye, when the lens is wet or dry. One eye (study eye) contributed to the analysis.|Day 7, Day 30, Day 60, Day 90|This analysis population includes all randomized subjects. Here, “n” is the total number of subjects with crystalline deposits in each treatment group, respectively, by visit.||percentage of subjects|||Number
657846|NCT01912781|Primary|Percentage of Subjects With Visibly Clean Lenses|Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. A lens was considered visibly clean if it had nondetectable films or deposits. One eye (study eye) contributed to the analysis.|Day 7, Day 30, Day 60, Day 90|This analysis population includes all subjects with data at visit.||percentage of subjects|||Number
657847|NCT01912768|Primary|Film Deposit Area Covered|Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. Values were reported as a percentage of lens area covered. One eye (study eye) contributed to the analysis.|Day 7, Day 30, Day 60, Day 90|"This analysis population includes all randomized subjects. Here, n is the total number of subjects with film deposits in each treatment group, respectively, by visit."||percentage of lens area||Standard Deviation|Mean
657848|NCT01912768|Primary|Crystalline Deposit Area Covered|Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. Values were reported as a percentage of lens area covered. One eye (study eye) contributed to the analysis.|Day 7, Day 30, Day 60, Day 90|"This analysis population includes all randomized subjects. Here, n is the total number of subjects with crystalline deposits in each treatment group, respectively, by visit."||percentage of lens area||Standard Deviation|Mean
657849|NCT01912768|Primary|"Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling."|Product handling was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects.|Day 7, Day 30, Day 60, Day 90|"This analysis population includes all randomized subjects. Here, n is the total number of subjects with data in each treatment group, respectively, by visit."||percentage of subjects|||Number
657850|NCT01912768|Primary|"Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear."|Clear vision was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects.|Day 7, Day 30, Day 60, Day 90|"This analysis population includes all randomized subjects. Here, n is the total number of subjects with data in each treatment group, respectively, by visit."||percentage of subjects|||Number
657851|NCT01912768|Primary|"Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day."|Lens comfort was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects.|Day 7, Day 30, Day 60, Day 90|"This analysis population includes all randomized subjects. Here, n is the total number of subjects with data in each treatment group, respectively, by visit."||percentage of subjects|||Number
657852|NCT01912768|Primary|Number of Unscheduled Lens Replacements by Reason|A fresh pair of lenses was dispensed on Day 0, Day 30, and Day 60. Lenses replaced at other times were considered unscheduled. The counts in the table represent the total number of unscheduled lenses replaced by reason for any eye, any subject.|Up to Day 90|This analysis population includes all randomized subjects.||lenses|||Number
657853|NCT01912768|Primary|Average Lens Wear Time|"Subject recorded a response to the question, Averaging over the last 3 days, how many hours per day did you wear your contact lenses? Lens wear time was measured in hours."|Day 7, Day 30, Day 60, Day 90|"This analysis population includes all randomized subjects. Here, n is the total number of subjects with data in each treatment group, respectively, by visit."||Hours||Standard Deviation|Mean
657854|NCT01912768|Primary|Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change|Distance VA was assessed for each eye individually while reading a chart distant to the participant in dimmed room illumination. VA was measured using a Snellen chart, with 20/20 Snellen acuity considered normal distance-eyesight. A line increase indicates an improvement in VA. One eye (study eye) contributed to the analysis.|Baseline (Day 0), Day 7, Day 30, Day 60, Day 90|"This analysis population includes all randomized subjects. Here, n is the total number of subjects with data in each treatment group, respectively, by visit."||percentage of subjects|||Number
657855|NCT01912768|Primary|Average Residual Lens Lysozyme|Worn study lenses were removed and analyzed by high performance liquid chromatography (HPLC) for residual lens lysozyme (protein). Values reported as lower than the limit of quantitation or none detected were imputed as 0.5 μg or 0 μg, respectively. A lower value indicates less lysozyme deposition. One eye (study eye) contributed to the analysis.|Day 30/Early Exit|This analysis population includes all subjects with data at visit.||micrograms per lens||Standard Deviation|Mean
657856|NCT01912768|Primary|Percentage of Subjects With Film Deposits by Type|Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered: Type II = films or deposits visible only under special conditions, such as special illumination using an eyepiece of 7-10 times magnification, Type III = films or deposits readily visible on a dry lens under room lighting, with unaided eye, and Type IV = films or deposits obvious under room lighting, with unaided eye, when the lens is wet or dry. One eye (study eye) contributed to the analysis.|Day 7, Day 30, Day 60, Day 90|"This analysis population includes all randomized subjects. Here, n is the total number of subjects with film deposits in each treatment group, respectively, by visit."||percentage of subjects|||Number
657857|NCT01912768|Primary|Percentage of Subjects With Crystalline Deposits by Type|Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered: Type II = films or deposits visible only under special conditions, such as special illumination using an eyepiece of 7-10 times magnification, Type III = films or deposits readily visible on a dry lens under room lighting, with unaided eye, and Type IV = films or deposits obvious under room lighting, with unaided eye, when the lens is wet or dry. One eye (study eye) contributed to the analysis.|Day 7, Day 30, Day 60, Day 90|"This analysis population includes all randomized subjects. Here, n is the total number of subjects with crystalline deposits in each treatment group, respectively, by visit."||percentage of subjects|||Number
657858|NCT01912768|Primary|Percentage of Subjects With Visibly Clean Lenses|Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. A lens was considered visibly clean if it had nondetectable films or deposits. One eye (study eye) contributed to the analysis.|Day 7, Day 30, Day 60, Day 90|"This analysis population includes all randomized subjects. Here, n is the total number of subjects with data in each treatment group, respectively, by visit."||percentage of subjects|||Number
657859|NCT01912599|Primary|Systolic Pressure|The value shown in the table is the mean of all measurements taken over the 24 hour period, so it is the average value.|24 Hours|||mmHg||Standard Deviation|Mean
657860|NCT01912599|Primary|Diastolic Pressure|The value shown in the table is the mean of all measurements taken over the 24 hour period, so it is the average value.|24 Hours|||mmHg||Standard Deviation|Mean
657861|NCT01912599|Primary|Mean Perfusion Pressure|The value shown in the table is the mean of all measurements taken over the 24 hour period, so it is the average value.|24 Hours|||mmHg||Standard Deviation|Mean
657862|NCT01912599|Primary|Intraocular Pressure|The IOP provided is the average of all 144 measurements taken during the 24 hour period.|24 Hours|||mEqv.||Standard Deviation|Mean
657863|NCT01912599|Primary|Arterial Pressure|The blood pressure value shown in the table is the mean of all measurements taken over the 24 hour period, so it is the average value.|24 Hours|"Data for two glaucoma patients were excluded for analysis because
In one patient the IOP recorder malfunctioned just two hours after set up, so data were not available for the entire 24 hours
In the other patient, the wireless sensor was disconnected from the recorder in the middle if the night so data could not be recorded."||mmHg||Standard Deviation|Mean
657864|NCT01912495|Secondary|Safety: Treatment Related (Serious) Adverse Events ((S)AE) and Treatment Discontinuation for (S)AE.|only serious adverse events are recorded in this secondary endpoint|72 weeks|57 patients started treatment and were at risk||participants|||Number
657865|NCT01912495|Secondary|Alterations of Biomarkers by Therapy Induced Viral Eradication: Viral Sequencing, Mutation Analysis, Gene Expression Analysis, and RNA Analysis.||72 weeks|data were not collected during this study|||||
657866|NCT01912495|Secondary|SVR 12 Weeks After End of Therapy in Patients That Started Therapy ≤12weeks After the Presumed HCV Infection Date Versus Those After 12 Weeks.|The number of patients having a undetectable HCV RNA 12 weeks after the end of treatment in the group patients that was treated within 12 week of calculated transmission date.|12 weeks|5 patients were treated within 12 weeks after calculated transmission date. All other patients were treated between 12 and 26 weeks after calculated transmission date.||participants|||Number
657867|NCT01912495|Secondary|SVR 12 Weeks After End of Therapy in Patients With Already a RVR at Week 1.|The number of patients who were undetectable for HCV at week one that had an undetectable HCV RNA load 12 weeks after the end of treatment|12 weeks|All patients having a rapid viral response at week 4 had a sustained viral response at 12(SVR12) weeks after treatment.||participants|||Number
657868|NCT01912495|Secondary|SVR 12 Weeks After the End of All Therapy in the Entire Study Population (With or Without RVR4).|The outcome is a number of all patients who started treatment having an undetectable HCV RNA 12 weeks after the end of therapy|12 weeks|Total intention to treat population||participants|||Number
657869|NCT01912495|Primary|Sustained Viral Response(SVR) 12 Weeks of Follow up After the End of All Therapy for the Rapid Viral Response at Week 4(RVR4) Population.|The outcome is a number of the patients with an undetectable Hepatitis C Virus (HCV) RNA at week 4 that have an undetectable HCV RNA 12 weeks after end of treatment.|12 weeks|41 patients had a RVR4||participants|||Number
657943|NCT01911273|Secondary|Number of Participants With Human Anti-Human Antibodies (HAHA)||Cycle 1, 2, 4, 6, 8 Day 1 at 0 hour (pre-dose)|The immunogenicity assessment consisted of all participants who had at least 1 sample on at least 1 day of immunogenicity assessment.||Participants|||Number
657871|NCT01912352|Secondary|Clinical Global Impression-Improvement Scale at 8 Weeks|"Clinical Global Impression-Improvement (CGI-I) scale is a one-item measure evaluating the change from the initiation of treatment on a seven-point scale: “Compared to the patient's condition at baseline [prior to medication initiation], this patient's condition is: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment.
Clinical Global Impression-Improvement was measured at 8 weeks."|baseline and 8 weeks|||units on a scale||Standard Deviation|Mean
657872|NCT01912352|Primary|Change From Baseline ADHD Rating Scale-IV Scores at 8 Weeks|"Attendtion-deficit hyperactivity disorder (ADHD) Rating Scale-IV is the sum of 18 questions, ranging from 0 (no symptoms) to 54 (worst possible symptoms).
Change from baseline ADHD Rating Scale-IV scores at 8 weeks was calculated as baseline minus 8 weeks."|baseline and 8 weeks|||units on a scale||Standard Deviation|Mean
657873|NCT01912339|Secondary|Responders at 12 Months|Number of subjects with a greater than or equal to 30% improvement (reduction) in the International Prostate Symptom score (IPSS) at 12 months compared to baseline.|12 Months|Intention to Treat population (ITT) for treatment subjects only. Control subjects randomized follow-up concluded at 3 months.||Participants|||Number
657874|NCT01912339|Secondary|Responders at 6 Months|Number of subjects with a greater than or equal to 30% improvement (reduction) in the International Prostate Symptom score (IPSS) at 6 months compared to baseline.|6 Months|Intention to Treat population (ITT) for treatment subjects only. Control subjects randomized follow-up concluded at 3 months.||Participants|||Number
657875|NCT01912339|Secondary|Responders at 3 Months|Number of subjects with a greater than or equal to 30% improvement (reduction) in the International Prostate Symptom score (IPSS) at 3 months compared to baseline.|3 Months|Intention to Treat population (ITT)||Participants|||Number
657876|NCT01912339|Primary|Safety: Device Related Serious Complications|"This safety endpoint will be to demonstrate that the composite observed rate of post-procedure device related serious complications in the Treatment Arm are is less than or equal to 12% at 3 months.
Composite device related serious complications for this endpoint are 1) De Novo (new) severe urinary retention lasting more than 21 consecutive days post treatment, 2) Device related formation of fistula between the rectum and urethra, and 3) device perforation of the rectum or GI tract. Twelve percent was a pre-specified performance goal for the safety endpoint."|3 Months|Intention to Treat population (ITT) for treatment arm subjects only. Control subjects did not undergo a treatment procedure so they were not assessed for this endpoint.||Participants||95% Confidence Interval|Number
657877|NCT01912339|Primary|Efficacy: Change From Baseline in the International Prostate Symptom Score (IPSS) at 3 Month Follow-Up|Comparison of the change in BPH symptoms as measured by IPSS change between the Treatment and Control arm at 3 months post-treatment. The IPSS is a well-validated, highly reliable and responsive American Urological Association symptom score (AUASS) assessment to identify the severity of BPH Symptoms. The first seven questions of the IPSS Questionnaire address frequency, nocturia, weak urinary stream, hesitancy, intermittence, incomplete emptying and urgency each on a scale of 0 to 5. The total score, summed across the seven items measured, ranges from 0 (no symptoms) to 35 (most severe symptoms).|3 Month Follow-up Visit|Intention to Treat population (ITT)||Cange in IPSS score||95% Confidence Interval|Mean
657878|NCT01912222|Primary|Number of Participants Reporting Clinically Significant Change From Baseline in Vital Signs|Vital signs included body temperature (oral or tympanic measurement), sitting blood pressure (after the participant has rested for at least 5 minutes), and pulse (bpm).|Baseline up to Day 15 for each treatment cycle (28 days treatment cycle for up to a maximum of 12 cycles)|The safety analysis population was defined as participants who received at least 1 dose of ixazomib.||participants|||Number
657879|NCT01912222|Primary|Number of Participants Reporting Clinically Significant Change From Baseline in Laboratory Values|The number of participants with any markedly abnormal standard safety laboratory values collected throughout study.|Baseline up to Day 15 for each treatment cycle (28 days treatment cycle for up to a maximum of 12 cycles)|The safety analysis population was defined as participants who received at least 1 dose of ixazomib.||participants|||Number
657880|NCT01912222|Primary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE) and Serious Adverse Events (SAE)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|Baseline up to 30 days after last dose of study drug (Day 45 for each treatment cycle for up to a maximum of 12 cycles [28 days treatment cycles])|The safety analysis population was defined as participants who received at least 1 dose of ixazomib.||participants|||Number
657881|NCT01912222|Primary|Tmax- Time to Reach the Maximum Plasma Concentration (Cmax) for Ixazomib||Part A, Day 1: Pre-dose and at multiple timepoints (up to 336 hours) post-dose|The PK analysis population was defined as participants who received the single dose of ixazomib in Part A of the study, did not receive any excluded concomitant medications through the completion of PK sampling, and had sufficient concentration-time data to permit the reliable estimation of PK parameters by noncompartmental analysis methods.||hours||Full Range|Median
657882|NCT01912222|Primary|Unbound Cmax: Unbound Maximum Observed Plasma Concentration for Ixazomib||Part A, Day 1: Pre-dose and at multiple timepoints (up to 336 hours) post-dose|The PK analysis population was defined as participants who received the single dose of ixazomib in Part A of the study, did not receive any excluded concomitant medications through the completion of PK sampling, and had sufficient concentration-time data to permit the reliable estimation of PK parameters by noncompartmental analysis methods.||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
657883|NCT01912222|Primary|Unbound AUC(0-last): Unbound Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Ixazomib||Part A, Day 1: Pre-dose and at multiple timepoints (up to 336 hours) post-dose|The PK analysis population was defined as participants who received the single dose of ixazomib in Part A of the study, did not receive any excluded concomitant medications through the completion of PK sampling, and had sufficient concentration-time data to permit the reliable estimation of PK parameters by noncompartmental analysis methods.||nanogram*hours per milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
657884|NCT01911845|Secondary|Plasma Trough Concentration (Ctrough) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin|Blood samples were collected pre-dose (time 0) and at 2, 4, 6, and 24 hours post-dose at one visit between treatment week 2 and treatment week 12, and analyzed using validated analytical methods. A total of 22/38 participants consented for intensive pharmacokinetic blood sampling. Minimum plasma concentration (C trough; measured in ng/mL) was directly determined from the concentration-time data.|Pre-dose (time 0) and 2, 4, 6, and 24 hours post-dose|Participants who consented for intensive pharmacokinetic blood sampling||ng/mL||Standard Deviation|Mean
657885|NCT01911845|Secondary|Time to Maximum Plasma Concentration (Tmax) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin|Blood samples were collected pre-dose (time 0) and at 2, 4, 6, and 24 hours post-dose at one visit between treatment week 2 and treatment week 12, and analyzed using validated analytical methods. A total of 22/38 participants consented for intensive pharmacokinetic blood sampling. The time to maximum plasma concentration (Tmax; measured in hours) was directly determined from the concentration-time data.|Pre-dose (time 0) and 2, 4, 6, and 24 hours post-dose|Participants who consented for intensive pharmacokinetic blood sampling||hours||Standard Deviation|Mean
657886|NCT01911845|Secondary|Maximum Plasma Concentration (Cmax) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin|Blood samples were collected pre-dose (time 0) and at 2, 4, 6, and 24 hours post-dose at one visit between treatment week 2 and treatment week 12, and were analyzed using validated analytical methods. A total of 22/38 participants consented for intensive pharmacokinetic blood sampling. Maximum plasma concentration (Cmax; measured in ng/mL) was directly determined from the concentration-time data.|Pre-dose (time 0) and 2, 4, 6, and 24 hours post-dose|Participants who consented for intensive pharmacokinetic blood sampling||ng/mL||Standard Deviation|Mean
657887|NCT01911845|Secondary|Area Under the Plasma Concentration-time Curve (AUC) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin|Blood samples were collected pre-dose (time 0) and at 2, 4, 6, and 24 hours post-dose at one visit between treatment week 2 and treatment week 12, and were analyzed using validated analytical methods. A total of 22/38 participants consented for intensive pharmacokinetic blood sampling. Area under the plasma concentration-time curve from time 0 to 24 hours (AUC24 in ng*hr/mL)] was estimated using noncompartmental analyses. For ABT-450, ritonavir, and ABT-267, the AUC from time 0 to the last measureable concentration (AUCt in ng*hr/mL) was calculated instead of AUC24 due to time deviations at 24 hours. The AUCt values are approximately equivalent to AUC24. For ABT-333, ABT-333 M1, and RBV, the AUC from time 0 to 12 hours (AUC12 in ng*hr/mL) after the morning dose was calculated using the 24-hour concentration as the 12-hour concentration as dosing was twice a day and a 12-hour sample was not collected in this study.|Pre-dose (time 0) and 2, 4, 6, and 24 hours post-dose|Participants who consented for intensive pharmacokinetic blood sampling||ng*hr/mL||Standard Deviation|Mean
657888|NCT01911845|Secondary|Percentage of Participants With Virologic Relapse Post-treatment|Participants were considered to have virologic relapse after treatment if they had confirmed quantifiable plasma Hepatitis C virus ribonucleic acid (HCV RNA) ≥ lower limit of quantification (LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA < LLOQ at the end of treatment. Completion of treatment was defined as a study drug duration ≥ 77 days.|From the end of treatment through 12 weeks after the last actual dose of study drug|All randomized participants who received at least 1 dose of study drug with HCV RNA < LLOQ at the final treatment visit who completed treatment.||Percentage of participants|||Number
657889|NCT01911845|Secondary|Percentage of Participants With Virologic Failure During Treatment|Virologic failure during treatment was defined as rebound (confirmed HCV RNA greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA < LLOQ during treatment, or confirmed increase from the lowest value post baseline in HCV RNA [2 consecutive HCV RNA measurements > 1 log(subscript)10(subscript) IU/mL above the lowest value post baseline] at any time point during treatment) or fail to suppress (HCV RNA ≥ LLOQ) persistently during treatment with at least 6 weeks [≥ 36 days] of treatment.|Baseline (Day 1), and Treatment Weeks 1, 2, 4, 6, 8, 10, and 12|All enrolled participants who received at least 1 dose of study drug.||Percentage of participants|||Number
657890|NCT01911845|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment|The percentage of participants with sustained virologic response (plasma hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantification [< LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of study drug|All enrolled participants who received at least 1 dose of study drug.||Percentage of participants||95% Confidence Interval|Number
657891|NCT01911793|Secondary|Diagnosis of Postoperative Ileus|diagnosis of postoperative ileus or bowel obstruction made by attending surgeon based on clinical data including abdominal distention, nausea/vomiting, decreased stom output and radiologic factors|30 day postoperative period|Data were not collected and no data was analyzed study was terminated due to issues with study enrollment and study administrative coverage.|||||
657892|NCT01911793|Secondary|Episodes of Vomiting|any episodes of vomiting will be recorded|during postoperative hospital admission (30 day period)|Data were not collected and no data was analyzed study was terminated due to issues with study enrollment and study administrative coverage.|||||
657893|NCT01911793|Secondary|Any Insertion of Nasogastric Tube|insertion of nasogastric tube after surgery will be recorded|30 day postoperative period|Data were not collected and no data was analyzed study was terminated due to issues with study enrollment and study administrative coverage.|||||
657894|NCT01911793|Secondary|Major and Minor Medical and Surgical Complications|any major or minor medical and surgical complications after surgery will be recorded|30 day postoperative period|Data were not collected and no data was analyzed study was terminated due to issues with study enrollment and study administrative coverage.|||||
657895|NCT01911793|Secondary|Time to Discharge Based on GI Function|postoperative day which patient is considered ready for discharge based solely on Gastrointestinal function|30 day postoperative period||||||
657896|NCT01911793|Secondary|Hospital Discharge|postoperative day after surgery which patient was discharged home|30 day postoperative period|Data were not collected and no data was analyzed study was terminated due to issues with study enrollment and study administrative coverage.|||||
657897|NCT01911793|Secondary|Time to Passage of Stool|# of hours after surgery until the patient passes stool into stoma bag|during 30 day postoperative period|Data were not collected and no data was analyzed study was terminated due to issues with study enrollment and study administrative coverage.|||||
657900|NCT01911780|Secondary|Change From Baseline in Mean Seated SBP at Trough After 52 Weeks of the Extension Period.|"Change from baseline in mean seated systolic blood pressure at trough after 52 weeks of the extension period. Note, week 52 of the extension period corresponds to 60 weeks after the reference baseline.
The results are presented as 'change' rather than 'reduction' i.e., reductions are expressed with negative values’. The 'adjusted mean' is shown as 'mean'."|Reference baseline (week 0) and week 60 (end of extension period)|FASEX (OC)||mmHg||Standard Error|Mean
657901|NCT01911780|Secondary|Change From Baseline in Mean DBP Pressure at Trough After 52 Weeks of the Extension Period.|"Change from baseline in mean seated diastolic blood pressure at trough after 52 weeks of the extension period. Note, week 52 of the extension period corresponds to 60 weeks after the reference baseline.
The results are presented as 'change' rather than 'reduction' i.e., reductions are expressed with negative values’. The 'adjusted mean' is shown as 'mean'."|Reference baseline (week 0) and week 60 (end of extension period)|FAS in the extension period (FASEX OC) was defined as a collection of patients i) included in the FAS; ii) taking at least 1 dose of T80/A5/H12.5 mg in the extension period; and iii) taking measurements of seated DBP at reference baseline and at 1 or more time points in the extension period.||mmHg||Standard Error|Mean
657902|NCT01911780|Secondary|The Number of Patients With DBP<90 mmHg and SBP<140 mmHg Blood Pressure at Trough After 52 Weeks of Extension Period.|"The number of patients with DBP<90 mmHg and SBP<140 mmHg as seated blood pressure at trough after 52 weeks of the extension period. Note, week 52 of the extension period corresponds to 60 weeks after the reference baseline.
The results are presented as 'change' rather than 'reduction' i.e., reductions are expressed with negative values’. The 'adjusted mean' is shown as 'mean'."|Reference baseline (week 0) and week 60 (end of extension period)|FAS||Participants|||Number
657903|NCT01911780|Secondary|The Percentage of Patients With DBP<90 mmHg and SBP<140 mmHg Blood Pressure at Trough After 8 Weeks of Double-blind Period.|The percentage of patients with DBP<90 mmHg and SBP<140 mmHg as seated blood pressure at trough after 8 weeks of the double-blind period. The results are presented as 'change' rather than 'reduction' i.e., reductions are expressed with negative values’. The 'adjusted mean' is shown as 'mean'.|Double-blind and 8 weeks|FAS||Participants||95% Confidence Interval|Number
657904|NCT01911780|Secondary|Change From Baseline in Mean Seated SBP at Trough After 8 Weeks of the Double-blind Period.|Change from baseline in mean seated systolic blood pressure (SBP) at trough after 8 weeks of the double-blind period. The results are presented as 'change' rather than 'reduction' i.e., reductions are expressed with negative values’. The 'adjusted mean' is shown as 'mean'.|baseline and 8 weeks|FAS||mmHg||Standard Error|Mean
657905|NCT01911780|Primary|Change From Baseline in Mean Seated DBP at Trough After 8 Weeks of the Double-blind Period.|Change from baseline in mean seated diastolic blood pressure (DBP) at trough (24-hour post dosing) after 8 weeks of the double-blind period. The results are presented as 'change' rather than 'reduction' i.e., reductions are expressed with negative values’. The 'adjusted mean' is shown as 'mean'.|baseline and 8 weeks|Full analysis set (FAS) was, conforming to the intent-to-treat principle, defined as all patients i) included in the treated set; and ii) taking measurements of seated DBP at reference baseline and at 1 or more time points during the double-blind period||mmHg||Standard Error|Mean
657906|NCT01911689|Secondary|The Relationship Between the T2* Value and the Severity of AP According to Apache II|In clinical practice, the physician usually used the APACHE II to evaluate the severity of acute pancreatitis. AP was graded as mild (0-7 points) and severe AP (≥8 points) according to the APACHE II scoring system.|1 year|Indengpent T test||ms||Standard Deviation|Mean
657907|NCT01911689|Secondary|The T2* Value in Different Severity of AP According to MRSI|AP was graded as mild (0-3 points), moderate (4-6 points) or severe (7-10 points), according to the MR-severity index (MRSI) which was derived from the CT-severity index .|1 year|AP was graded as mild (0-3 points), moderate (4-6 points) or severe (7-10 points), according to the MR-severity index (MRSI) which was derived from the CT-severity index .||ms||Standard Deviation|Mean
657908|NCT01911689|Secondary|The Difference of T2* Value Between the Edematous AP and Necrotizing AP|Compare the difference of the T2* value between the edematous AP group and necrotizing AP group|1 year|compare the difference of T2* value between the edematous AP and necrotizing AP||ms||Standard Deviation|Mean
657909|NCT01911689|Primary|The T2* Values in the Diagnosis of AP|Compare the difference of the T2* value between the AP group and the control group.|1 year|compare T2* value between the AP group and the control group using independent sample t test||ms||Standard Deviation|Mean
657910|NCT01911442|Secondary|Proportion of Subjects Who Have at Least 25% Reduction From Baseline to Week 6 in the ABC Irritability Subscale Score.||6 Weeks|ITT||percentage of subjects|||Number
657911|NCT01911442|Secondary|Proportion of Subjects Who Have CGI-I Score of 1 (Very Much Improved) or 2 (Much Improved) at Week 6||6 Weeks|ITT - the current data presented is at week 6.||percentage of subjects|||Number
657912|NCT01911442|Secondary|Change From Baseline in the Caregiver Strain Questionnaire (CGSQ)|CGSQ is a caregiver reported assessment to assesses extent to which caregivers are affected by special demands associated with caring for a child with emotional/behavioral problems. CGSQ is comprised of three subscales which range in severity from 1 to 5 (Objective Strain, Subjective Externalized Strain, Subjective Internalized Strain), The 3 subscales are calculated as the averages of the corresponding individual items. Higher scores on each indicates greater strain. A Global Strain score is calculated by summing the three subscales (Objective Strain, Subjective Externalized Strain, Subjective Internalized Strain) to provide an indication of the total impact of the special demands on the family. Global Strain scores range from 3 to 15. As with the individual subscales, higher scores indicate greater strain.|6 Weeks|ITT||units on a scale||Standard Error|Least Squares Mean
657913|NCT01911442|Secondary|Change From Baseline in Children's Yale-Brown Obsessive Compulsive Scales (CY-BOCS) Modified for Pervasive Developmental Disorders (PDDs)|CY-BOCS total score ranges from 0 to 20. The higher value of CY-BOCS scores the greater severity of illness. This table is a summary of Y-BOCS compulsion total score.|6 Weeks|ITT||units on a scale||Standard Error|Least Squares Mean
657914|NCT01911442|Secondary|Change From Baseline in Aberrant Behavior Checklist (ABC) Hyperactivity Subscale Score at Week 6|The ABC hyperactivity and noncompliance subscale score is the sum of 16 items, each rated among 0 = Not at all; 1 = Slight in degree; 2 = Moderately serious; and 3 = Severe in degree. The ABC hyperactivity and noncompliance subscale score may range from 0 to 48. In general, higher values of ABC subscale scores represent greater severity of illness.|Baseline to 6 Weeks|ITT||units on a scale||Standard Error|Least Squares Mean
657915|NCT01911442|Secondary|Change From Baseline in Clinical Global Impression-Severity (CGI-S) at Week 6|The Clinical Global Impression – Severity of Illness (CGI-S) Scale is rated on a 7-point scale of severity with 1 = Normal, not at all ill to 7 = Among the most extremely ill patients. Higher values of CGI-S scores represent greater severity of illness.|Baseline to 6 Weeks|Intent to treat population. 49 in the placebo arm is correct. One subject in the placebo group did not receive the study medication, and therefore that subject was removed from the ITT population. A total of 50 subjects were randomized and 49 subjects were included in the placebo group of the ITT population.||units on a scale||Standard Error|Least Squares Mean
657916|NCT01911442|Primary|Change in Aberrant Behavior Checklist (ABC) Irritability Subscale Score at Week 6|The ABC irritability subscale score is the sum of 15 items, each rated among 0 = Not at all; 1 = Slight in degree; 2 = Moderately serious; and 3 = Severe in degree. The ABC irritability subscale score ranges from 0 to 45. Higher values of ABC subscale scores represent greater severity of illness.|Baseline to 6 Weeks|Intent to treat (ITT) population includes all randomized subjects who receive at least one dose of study medication and have at least one post-baseline assessment in any efficacy variable.||units on a scale||Standard Error|Least Squares Mean
657917|NCT01911429|Secondary|Change From Baseline in PANSS Excitability Subscale Scores|"Excitability subscale scores (range 4-28): consists of the following four items from the PANSS: excitement, hostility, uncooperativeness, and poor impulse control
Higher values of PANSS Excitability Subscale Score represent greater severity of illness
LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures with fixed effects terms for treatment, visit (as a categorical variable), pooled country, age strata, corresponding PANSS subscale score at baseline, and treatment-by-visit interaction."|baseline, week 6|ITT population||units on a scale||Standard Deviation|Mean
657918|NCT01911429|Secondary|Change From Baseline in PANSS General Psychopathology Subscale Scores|"PANSS general psychopathology subscale score: changes from baseline over time - mixed model for repeated measures -– General psychopathology (range 16-112): sum of Items G1 to G16 in the general psychopathology subscale -Higher values of PANSS General Psychopathology Subscale Score represent greater severity of illness
LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures with fixed effects terms for treatment, visit (as a categorical variable), pooled country, age strata, corresponding PANSS subscale score at baseline, and treatment-by-visit interaction."|baseline, week 6|ITT population||units on a scale||Standard Deviation|Mean
657919|NCT01911429|Secondary|Change From Baseline in Clinician-rated Children’s Global Assessment Scale (CGAS)|"Clinician-rated Children’s Global Assessment Scale (CGAS) score: summary statistics over time - CGAS is a numeric scale (1 through 100) , where 1 represents the most impaired functioning and 100, superior functioning
LS Mean and SE for change from baseline are from an ANCOVA model including factors of treatment, pooled country and age group (stratification factor), and corresponding Baseline score as covariate and LOCF approach."|baseline, week 6|ITT population||units on a scale||Standard Deviation|Mean
657920|NCT01911429|Secondary|Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q)|"PQ-LES-Q percentage maximum possible score: summary statistics over time - PQ-LES-Q % maximum possible score can range from 0% to 100%. Higher scores indicate better quality of life.
LS Mean and SE for change from baseline are from an ANCOVA model including factors of treatment, pooled country and age group (stratification factor), and corresponding Baseline score as covariate and LOCF approach."|baseline, week 6|ITT population||units on a scale||Standard Deviation|Mean
657921|NCT01911429|Secondary|Proportion of Responders, Where Response is Based on ≥ 20% Improvement From Baseline in PANSS Total Score at Week 6|PANSS responder analysis over time: achieving >= 20% reduction from baseline|week 6|ITT Population||number of participants|||Number
657922|NCT01911429|Secondary|Change From Baseline in PANSS Positive, Negative Subscale Scores|"PANSS Negative subscale score: changes form baseline over time - Mixed model for repeated measures - – Negative subscale (range 7-49): sum of Items N1 to N7 in the negative subscale - Higher values of PANSS Negative Subscale Score represent greater severity of illness
LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures with fixed effects terms for treatment, visit (as a categorical variable), pooled country, age strata, corresponding PANSS subscale score at baseline, and treatment-by-visit interaction."|baseline, week 6|ITT population||units on a scale||Standard Deviation|Mean
657923|NCT01911429|Secondary|Change From Baseline in PANSS Positive Subscale Scores|"PANSS positive subscale score: changes from baseline over time - mixed model for repeated measures –Positive subscale (range 7-49): sum of Items P1 to P7 in the positive subscale - Higher values of PANSS Positive Subscale Score represent greater severity of illness
LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures with fixed effects terms for treatment, visit (as a categorical variable), pooled country, age strata, corresponding PANSS subscale score at baseline, and treatment-by-visit interaction."|baseline, week 6|ITT population||units on a scale||Standard Deviation|Mean
657924|NCT01911429|Secondary|Change From Baseline in Clinical Global Impression Severity (CGI-S) Scale|"Clinical Global Impression severity (CGI-S): Changes from baseline over time-mixed model for repeated measures- scale from 1-7 - 1=normal, not at all ill; 7=among the most extremely ill patients.
LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures with fixed effects terms for treatment, visit (as a categorical variable), pooled country, age strata, CGIS at baseline, and treatment-by-visit interaction."|baseline, week 6|The ITT population includes all randomized subjects who receive at least one dose of study medication and have at least one post-baseline assessment in any efficacy variable||units on a scale||Standard Deviation|Mean
657925|NCT01911429|Primary|Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6.|"PANNS total score: Changes from baseline over time - mixed model for repeated measures at week 6 -PANSS total score may range from 30 to 210- Higher values of PANSS total score represent greater severity of illness
LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures with fixed effects terms for treatment, visit (as a categorical variable), pooled country, age strata, PANSS total score at baseline, and treatment-by-visit interaction."|Baseline to 6 weeks|The ITT population includes all randomized subjects who receive at least one dose of study medication and have at least one post-baseline assessment in any efficacy variable.||units on a scale||Standard Deviation|Mean
657944|NCT01911273|Secondary|Trough Serum Concentration of PF-03446962 (Ctrough)||0 hour (predose) on Day 1 of Cycles 1, 2, 4, 6, and 8|The PK concentration set consisted of all participants who were treated and had at least one concentration on at least 1 day of PK assessment.||mcg/mL||Standard Error|Geometric Mean
657926|NCT01911403|Secondary|Percentage of Patients With Angio-Seal™ Deployment Success|"According the physician criteria, it will be YES If the anchor was deliver properly, the absorbable component remain in the correct point of the arterial puncture and no bleeding in the skin puncture."|At puncture closure|Only patients in the Angio-Seal arm is analyzed||percentage of patients|||Number
657927|NCT01911403|Secondary|Time to Discharge From Interventional Radiology Department|Time that the physician grants the patient the discharge order from the Radiology Department. If the patients has order to be hospitalized up to 24h after the puncture closure by the radiologist, then, the discharge from the radiology department will be 24h, even if the patient needs to continue hospitalized in other department.|At discharge|||hours||Standard Deviation|Mean
657928|NCT01911403|Secondary|Number of Patients With Time to Hemostasis Between 4-60 Minutes|"Time to hemostasis is the time from the beginning of closure procedure, until the physician take away their hands from the patient, regardless the closure procedure, and confirm the stop of bleeding."|At puncture closure|||participants|||Number
657929|NCT01911403|Secondary|Number of Patients With Time to Hemostasis Between 0-4 Minutes|"Time to hemostasis is the time from the beginning of closure procedure, until the physician take away their hands from the patient, regardless the closure procedure, and confirm the stop of bleeding."|At puncture closure|||participants|||Number
657930|NCT01911403|Secondary|Number of Patients With Any Complications|"Number of patients with any complications since the puncture closure until 2 weeks ± 1 week.
The complications are related to the puncture closure evaluated at closure, discharge and follow-up. These include hematoma, Inferior limb ischemia, prolonged pain at puncture site, puncture site local infection, pseudoaneurysm, significant bleeding and vessel occlusion."|At puncture closure procedure, at discharge and at follow up (2 weeks+/-1 week)|||participants|||Number
657931|NCT01911403|Secondary|Number of Patients With Mobilization Time Between 4-48 Hours|Mobilization Time is the time that patient gets the authorization to flex the leg, sit or walk.|At discharge|||participants|||Number
657932|NCT01911403|Primary|Number of Patients With Mobilization Time Between 0-4 Hours|Mobilization Time is the time that patient gets the authorization to flex the leg, sit or walk.|At discharge|||participants|||Number
657933|NCT01911390|Secondary|Palatability|Other outcomes include palatability and acceptability of study-provided snacks that include cooked navy bean powder, rice bran, or a combination in children. The participants will fill out questionaires describing how the products tasted and how much they consumed.|Baseline, 4 weeks|The criteria used to quantify GI discomforts or issues included participants who responded ‘yes’ to any GI discomfort and rated the discomfort level ≥3 out of a 5-point scale.||Participants|||Count of Participants
657934|NCT01911390|Primary|Total Cholesterol|The primary outcome variable to be studied is total cholesterol. A full lipid panel report will also provide information on LDL, HDL, triglycerides etc.|Baseline, 4 weeks|||mg/dL||Standard Deviation|Mean
657935|NCT01911351|Other Pre-specified|Percentage of Providers Who Rated the Procedure as Being Successful|Survey collection of rating of success of the procedure by one provider. Answers were Strongly Agree, Agree, Neutral, Disagree and Strongly Disagree. The first two categories were combined.|measured at the end of each procedure, approximately 10 minutes after the completion of the procedure|||percentage of participants|||Number
657936|NCT01911351|Other Pre-specified|Percentage of Parents Who Reported That Their Child Was Comfortable During the Procedure|"A parental survey was collected post-procedure regarding the overall comfort of the child during the procedure. Other questions included whether the procedure was successfully completed, if the procedure went better than expected, was the parent pleased with the medications used and whether the child tolerated the procedure. Answers were Strongly Agree, Agree, Neutral, Disagree and Strongly Disagree. We chose the question that asked whether the child was comfortable during the procedure as it was most relevant. The categories Strongly Agree and Agree were combined in both groups."|measured at the end of each procedure, approximately 10 minutes after the procedure is completed|In the Standard Management arm, 38/39 parents completed the survey||percentage of participants|||Number
657937|NCT01911351|Other Pre-specified|Length of the Procedure|Another outcome measure is to compare the change in length of the procedure with or without nitrous oxide intervention.|measure time duration of each procedure, average 5-15 minutes|||minutes||Inter-Quartile Range|Median
657938|NCT01911351|Secondary|M-YPAS Anxiety Scale|Secondary outcome will be the Modified YALE Preoperative Anxiety Scale, measured pre-procedure, and intra-procedure. This is a validated scale measuring anxiety by assessment of Activity, Vocalization, Emotional Expressivity, State of Arousal and Use of Parents. All categories have a maximum score of 4 except for Vocalization with a maximum score of 6. The scores within each category are totaled and a total anxiety score is reported ranging from 5 (no anxiety) to 22 (highest level of anxiety).|measured pre-procedure at time provider explains procedure to the patient, and during procedure at peak pain time approximately 2-5 minutes into the procedure|||units on a scale||Inter-Quartile Range|Median
657939|NCT01911351|Primary|FLACC Pain Scale|The primary outcome will be the FLACC (Face, Legs, Activity, Cry, Consolability) Pain scale measured intra-procedure. The scale measures facial expression, movement of legs, general activity, presence and quality of cry and the need and ability to be consoled. Scoring for each category ranges from 0 (no response to pain) to 2 (maximum response to pain). The scores are totaled and a total score ranging from 0-10 is reported.|peak pain during procedure approximately 2-5 minutes into the procedure|||units on a scale||Inter-Quartile Range|Median
657940|NCT01911273|Secondary|Observed Serum Concentration of Circulating Protein||Cycle 1 Day 1 (before infusion), Cycle 4 Day 1 (before infusion), at disease progression/participant withdrawal.|FAS included all randomized participants regardless of what treatment, if any, was received.||mcg/mL|||Number
657941|NCT01911273|Secondary|Ratio to Baseline of Serum Circulating Protein Concentration|Protein involved TGFB1, VEGF-A, VEGF-C, PIGF, Endoglin, BMP-9, VEGFR1, VEGFR2, VEGFr3, Ang-2, VEGF-D, CD54, CD106, and CCL2. Tumor molecular characteristics including but not limited to transcriptomic (ribonucleic acid) signatures of efficacy.|Cycle 1 Day 1 (before infusion), Cycle 4 Day 1 (before infusion), at disease progression/participant withdrawal.|FAS included all randomized participants regardless of what treatment, if any, was received.||Percentage|||Number
657942|NCT01911273|Secondary|Presence of Sensitivity Signature|Tumor molecular characteristics including but not limited to transcriptomic (RNA) signatures of sensitivity|Cycle 1 Day 1 (before infusion), Cycle 4 Day 1 (before infusion), at disease progression/participant withdrawal.|FAS included all randomized participants regardless of what treatment, if any, was received.|||||
657946|NCT01911273|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Hepatobiliary Questionnaire (FACT-Hep)|Patient reported outcomes (PROs) were assessed using the FACT-Hep. The FACT-Hep included the FACT-general (FACT-G) and a hepatobiliary module, it consisted of the 27-item FACT-G, which assessed generic health-related quality of life (HRQoL) concerns, and the 18-item hepatobiliary subscale (HS), which assessed disease-specific issues. The questionnaire used a 5 point Likert scale from ‘0’ “not at all” to ‘4’ “very much” regarding how much each item was present in the last 7 days; lower score indicated severer symptom. Eight of the items (lack of energy, pain, weight loss, back pain, fatigue, stomach pain/discomfort, nausea, and jaundice) made up the Fact Hepatobiliary Symptom Index (FHSI 8) were considered to be symptoms specific to hepatobiliary cancer.|Screening, Cycle 1 Day1,8; Cycle >=2 Day1; End of treatment, survival follow-up up to 24 months after last participant randomization.|FAS included all randomized participants regardless of what treatment, if any, was received.||Units on scale||Standard Deviation|Mean
657947|NCT01911273|Secondary|Percentage of Participants With Disease Control Rate (DCR) at 16 Weeks|DCR was defined as the proportion of participants with confirmed CR or confirmed PR or a best response of stable disease (SD) >=16 weeks according to RECIST, relative to all randomized participants. CR was defined as disappearance of all target lesions. PR was defined as >=30% decrease in the sum of diameters of target lesions and non CR/non PD to non-target lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study.|From first randomization to date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months after last participant randomization|FAS included all randomized participants regardless of what treatment, if any, was received.||Percentage of Participants||95% Confidence Interval|Number
657948|NCT01911273|Secondary|Duration of Response (DR)|DR was defined as the time from the first documentation of objective tumor response to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first. If tumor progression data included >1 date, the first date was to be used. DR (in months) was calculated as the end date for DR minus date of first CR or PR that was subsequently confirmed plus 1 divided by 30.4. CR was defined as disappearance of all target lesions and non-target, if any. PR was defined as >=30% decrease in the sum of diameters of target lesions and non CR/non PD to non-target lesions.|From first randomization to date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months after last participant randomization|Subgroup of participants with objective response. Since objective response was not assessed in any of the participants, ideally the number of participants analyzed field should be 0 and the reason was insufficient data available to conduct adequate analysis due to premature termination of the study.|||||
657949|NCT01911273|Secondary|Objective Response Rate (ORR) - Percentage of Participants With Objective Response|ORR was defined as the proportion of participants with confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.1, relative to all randomized participants. CR were those that persisted on repeat imaging study more than or equal to (>=) 4 weeks after initial documentation of response. PR was defined as >=30% decrease in the sum of diameters of target lesions and non CR/non PD to non-target lesions. Participants who did not have on study radiographic tumor re-evaluation or who died, progressed or dropped out for any reason prior to reaching a CR or PR were to be counted as non-responders in the assessment of ORR. A participant who initially met the criteria for a PR and then subsequently became a confirmed CR, was to be assigned a best response of CR.|Screening and every 8 weeks by calendar thereafter, up to 24 months after last participant randomization.|FAS included all randomized participants regardless of what treatment, if any, was received.||Percentage of Participants|||Number
657950|NCT01911273|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time from randomization to first documentation of objective tumor progression or to death due to any cause, whichever occured first. If tumor progression data included >1 date, the first date was to be used. PFS (in months) was calculated as first event date minus first randomization date plus 1 divided by 30.4.|Screening and every 8 weeks by calendar thereafter, up to 24 months after last participant randomization.|FAS included all randomized participants regardless of what treatment, if any, was received.||Months||95% Confidence Interval|Median
657951|NCT01911273|Primary|Overall Survival (OS)|OS was the duration from date of randomization to date of death due to any cause. For participants who are alive, overall survival was censored at the last contact. Death was determined from adverse event (AE) data where outcome was death or from follow-up contact data where the participant current status was death.|From first randomization to date of death from any cause, whichever came first, assessed up to 24 months after last participant randomization|Full analysis set (FAS) included all randomized participants regardless of what treatment, if any, was received.||Months||95% Confidence Interval|Median
657952|NCT01911273|Secondary|Time to Tumor Progression (TTP)|TTP was defined as the time from first randomization to date of first documentation of objective tumor progression. If tumor progression data included more than (>) 1 date, the first date was to be used. TTP (in months) was calculated as first event date or last known progression-free date minus the first randomization date plus 1 divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease per Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1).|Screening and every 8 weeks by calendar thereafter, up to 24 months after last participant randomization.|FAS included all randomized participants regardless of what treatment, if any, was received.||Months||95% Confidence Interval|Median
657953|NCT01911260|Primary|Change in Height-for-Age Z-score (HAZ) From End of Supplementation to End of Follow-up Period.|"Schoolchildren were allocated into two homogeneous groups named Growth Deficit (HAZ < -1,5 Z-score), and Normal Height (HAZ between -1,0 and ±1,0 Z-score), and were randomly assigned to compose two exposed groups to receive a supplement of 30mg of zinc amino acid chelate, and two control groups to receive placebo individually once a week, during 12 weeks. Children's heights were measured at the End of Supplementation period and again after 12 weeks (Follow-up period). In combination with sex and age we transformed stature to Height-for-Age, expressed in Z-score, which was calculated as a number of standard deviations or Z-scores below or above the reference mean or median value, according to the formula below:
Z-score = (observed value - median value of the reference population) / standard deviation value of reference population.
We analyzed and discussed the change in HAZ (HAZ at the End of Follow-up period - HAZ at End of Supplementation)."|Height-for-Age Z-score was measured at the End of Supplementation period and again at the End of Follow-up period, with a 12 weeks interval.|||Z-Score||Standard Deviation|Mean
657954|NCT01911221|Primary|Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination).|Safety was assessed as the number of subjects who reported Serious Adverse Events (SAEs), medically attended AEs, AEs leading to withdrawal from the study, as collected from day 1 to day 91 following vaccination with rMenB+OMV NZ (a two dose schedule ) are reported.|Day 1 through Day 91 postvaccination.|Analysis was done on Unsolicited Safety Set.||Number of subjects|||Number
657955|NCT01911221|Primary|Number of Subjects Reporting Unsolicited Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination).|Safety was assessed as the number of subjects who reported unsolicited adverse events as collected from Day 1 to Day 91 following rMenB+OMV vaccination (a two dose schedule). Unsolicited adverse events were collected from day 1 through day 7 after each vaccination, while serious adverse events, medically attended adverse events and adverse events leading to withdrawal from study were reported from day 1 through day 91.|Day 1 through Day 91 postvaccination.|Analysis was done on Unsolicited Safety Set.||Number of subjects|||Number
657956|NCT01911221|Primary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination)|The number of subjects with solicited local and systemic adverse events after receiving rMenB+OMV NZ (a two dose vaccination schedule) collected from day 1 through day 7 are reported.|Day 1 through Day 7 postvaccination.|Analysis was done on Solicited Safety Set.||Number of Subjects|||Number
657957|NCT01911221|Primary|Percentages of Subjects With Four Fold Increase From Baseline For Vaccine Antigen 287-953 Following A Two-dose Vaccination Schedule.|The antibody responses were assessed to evaluate the four fold increases in ELISA concentrations as measured by ELISA to the vaccine antigen 287-953 following a two dose vaccination schedule with rMenB+OMV NZ vaccine at one month the second vaccination over baseline.|Day 1 and Day 91|Analysis was done on Full Analysis Set.||Percentage of Subjects||95% Confidence Interval|Number
657958|NCT01911221|Primary|Geometric Mean Ratios For Vaccine Antigen 287-953 Following A Two-dose Vaccination Schedule.|The antibody responses were assessed to evaluate the geometric mean ratios as measured by ELISA within the subjects for the vaccine antigen 287-953 following a two dose vaccination schedule with rMenB+OMV NZ vaccine at one month after the second vaccination versus baseline.|Day 1 and Day 91|Analysis was done on Full Analysis Set.||Ratio||95% Confidence Interval|Geometric Mean
657959|NCT01911221|Primary|Geometric Mean Concentrations For Vaccine Antigen 287-953 Following A Two-dose Vaccination Schedule|The antibody responses were assessed to evaluate the geometric mean concentrations as measured by Enzyme Linked Immunosorbent Assay (ELISA) in terms of percentages of subjects for the vaccine antigen 287-953 following a two dose vaccination schedule with rMenB+OMV NZ vaccine at baseline and at one month the second vaccination.|Day 1 and Day 91|Analysis was done on Full Analysis Set.||U/mL||95% Confidence Interval|Geometric Mean
657960|NCT01911221|Primary|Percentages Of Subjects With Four-Fold Increase In Human Serum Bactericidal Activity From Baseline Against N Meningitidis Serogroup B Strains Following a Two Dose Vaccination Schedule.|The antibody responses were assessed to evaluate the four fold increase in human serum bactericidal activity titers in terms of percentages of subjects against N meningitidis serogroup B (H44/76, 5/99, NZ98/254) and strain M10713 following a two dose vaccination schedule with rMenB+OMV NZ vaccine.|Day 91|Analysis was done on Full Analysis Set.||Percentage of subjects||95% Confidence Interval|Number
657961|NCT01911221|Primary|Percentages Of Subjects With hSBA≥ 1:8 Titers Against N Meningitidis Serogroup B Strains Following Two-Dose Vaccination Schedule.|The immunogenicity was assessed to evaluate the human serum bactericidal activity titers ≥ 1:8 in terms of percentages of subjects against N meningitidis serogroup B (H44/76, 5/99, NZ98/254) and strain M10713 following a two dose vaccination schedule with rMenB+OMV NZ vaccine.|Day1 and Day91|Analysis was done on Full Analysis Set.||Percentage of Subjects||95% Confidence Interval|Number
657962|NCT01911221|Primary|Percentages Of Subjects With hSBA≥ 1:5 Titers Against N Meningitidis Serogroup B Strains Following Two-Dose Vaccination Schedule.|The immunogenicity was assessed to evaluate the hSBA titers ≥ 1:5 in terms of percentages of subjects against N meningitidis serogroup B (H44/76, 5/99, NZ98/254) and strain M10713 following a two dose vaccination schedule with rMenB+OMV NZ vaccine.|Day1 and Day91|Analysis was done on Full Analysis Set.||Percentages of subjects||95% Confidence Interval|Number
657963|NCT01911221|Primary|Geometric Mean Ratios Against N Meningitidis Serogroup B Strains Following A Two-dose Vaccination Schedule|The immunogenicity was assessed to evaluate the hSBA in terms of geometric mean ratios within subjects against the indicator strains of N meningitidis serogroup B (H44/76, 5/99, NZ98/254) and strain M10713 at one month after the second vaccination versus baseline.|Day1 and Day 91|The analysis was done on the Full Analysis Set.||ratio||95% Confidence Interval|Geometric Mean
657964|NCT01911221|Primary|Geometric Mean Human Serum Bactericidal Activity Titers Against N Meningitidis Serogroup B Strains Following A Two-dose Vaccination Schedule|The immunogenicity was assessed to evaluate the human serum bactericidal activity (hSBA) against the indicator strains of N meningitidis serogroup B (H44/76, 5/99, NZ98/254) and M10713 strain at baseline and at one month after the second vaccination.|Day1 and Day 91|Analysis was done on Full Analysis Set||Titers||95% Confidence Interval|Geometric Mean
657965|NCT01911065|Other Pre-specified|Identify Predictors That Correlate With a Rapid and Diverse T Cell Response.|The investigators will use the frequency and TCR diversity of VZV-specific T cells on days 7 and 14 after vaccination as outcome variable and identify predictors that positively or negatively correlate with a rapid and diverse T cell response in the different age groups.|0 to 14 Days||||||
657966|NCT01911065|Secondary|Number of Participants With Related Adverse Events||0 to 35 Days|||Participants|||Count of Participants
657967|NCT01911065|Primary|Number of Participants Who Received Zostavax Immunization or Had Natural Exposure to VZV||Day 0 to Day 35|||Participants|||Count of Participants
657968|NCT01910831|Secondary|Investigator Global Assessment (IGA)|"To determine efficacy with respect to the IGA of improving the appearance of “bruising” and reducing the appearance of photoaging of the forearms and hands:
IGA:
0=No improvement
<25% improvement
25% to 50% improvement
51% to 75% improvement
>75% improvement"|12 Weeks|20 subjects were enrolled into the study in a 1:1 ratio (DerMend: Placebo Control). 40 arms were used in the final data analysis. After 84 days of treatment, there was no change in serious AEs, or any AEs. 40 arms were used in the final data analysis.||units on a scale||Standard Deviation|Mean
658406|NCT01903148|Secondary|Hemoglobin Levels Per Type of Patients|levels Hb and type of patients|1 day|n represents the number of participants analyzed for each category respectively (converted patients, naïve patients)||mg/dl||Standard Deviation|Mean
657969|NCT01910831|Primary|Reduction of Bruising|To determine the efficacy (measured at 12 weeks) of DerMend Moisturizing Bruise Formula in improving the appearance of bruising and reducing the appearance of photoaging of the forearms and hands in mature skin.|12 weeks|20 subjects were enrolled into the study in a 1:1 ratio (DerMend: Placebo Control). 40 arms were used in the final data analysis. After 84 days of treatment, there was no change in serious AEs, or any AEs. 40 arms were used in the final data analysis.||cm squared||Standard Deviation|Mean
657970|NCT01910792|Primary|# of Pts w/ Enhanced Vitamin D Status|Increase circulating 25(OH)D levels|Baseline, Months 1, 2, 3|Only 3 subjects in each Arm had a conclusive set of data eligible for analysis.||Participants|||Count of Participants
657971|NCT01910688|Secondary|Adverse Events|Adverse event profile: Relationship to study device : Definite, Probable, Possible|12 months|||number of events|||Number
657972|NCT01910688|Secondary|Patient Tolerability|Patient tolerability of the procedure. Patient tolerability will be measured by assessing adverse events related to the device or procedure. The Investigator will assess each adverse event with respect to severity and relationship to the study device.|12 months|||number of events|||Number
657973|NCT01910688|Secondary|Technical Feasibility: Percentage of Participants Who Completed RFA Treatment|Technical feasibility of applying RFA to gastric pouch and gastrojejunostomy. This will be assessed by asking the physician for feedback on ease of use, ease of intubation and extubation,did the physician achieve tissue contact in targeted areas, was targeted area successfully ablated.|Day 0, month 4, month 8|At 0 month, 25 received 1st RFA treatment; at 4 month, 22 received 2nd RFA treatment; at 8 month, 18 received RFA Treatment||percentage of participants|||Number
657974|NCT01910688|Primary|Excess Body Weight Loss After RFA Treatment|EBWL 12 months after enrollment|12 months|||percentage of EBWL||Standard Deviation|Mean
657975|NCT01910636|Secondary|Percentage of Participants Experiencing Viral Relapse|Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) at end of treatment, but did not achieve an SVR.|Up to Posttreatment Week 24|Full Analysis Set||percentage of participants|||Number
657976|NCT01910636|Secondary|Percentage of Participants Experiencing Viral Breakthrough|Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values.|Up to 12 weeks|Full Analysis Set||percentage of participants|||Number
657977|NCT01910636|Secondary|Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set||percentage of participants|||Number
657978|NCT01910636|Primary|Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)|The percentage of participants permanently discontinuing any study drug due to an adverse event was summarized.|Up to 12 weeks|Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug||percentage of participants|||Number
657979|NCT01910636|Primary|Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants who were enrolled, received at least 1 dose of study drug, and had chronic genotype 2 HCV infection.||percentage of participants|||Number
657980|NCT01910441|Primary|Mean Amplitude of Glycemic Excursions (MAGE)||16 weeks|The study was prematurely terminated due to the unavailability of CGMS required for the assessment of the primary end point. The non-availability of CGMS severely affected participant recruitment. The primary outcome was not analyzed.|||||
657981|NCT01910402|Secondary|Number of Participants With Treatment Emergent Resistances|Number of participants, who meet confirmed virologic withdrawal criteria, with treatment emergent genotypic resistance to INI, NNRTI, NRTI, PI will be summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. On-treatment Genotypic Resistance Population comprised of all participants in the ITT-E population with available On-treatment genotypic resistance data at the time confirmed virologic withdrawal criterion was met.|Up to week 48|On-treatment Genotypic Resistance Population||Participants|||Number
657982|NCT01910402|Secondary|Number of Participants With Post-Baseline HIV-1 Disease Progression|Number of participants with post-Baseline HIV-1disease progression were assessed during study period. The CDC Classification System for HIV Infection is the medical classification system used by the United States Centers for Disease Control and Prevention (CDC) to classify HIV disease and infection. The clinical categories of HIV infection are defined as follows: Category A: Mildly symptomatic, Category B: Moderately symptomatic, Category C: Severely symptomatic. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Only those participants available at the specified time points were analyzed. Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population.|Up to week 48|ITT-E Population, only those participants who experienced a disease progression to CDC Class C or death were analyzed.||Participants|||Number
657983|NCT01910402|Secondary|Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups|Percentage of participants with plasma HIV-1 RNA <50 copies/mL at Week 48 by subgroups (age, race, country, Baseline plasma HIV-1 RNA (BPHR), Baseline CD4+ cell count (BCCC), Baseline Centers for Disease Control and Prevention (CDC) category and HIV-1 subtype) were assessed using the Snapshot algorithm (Missing, Switch or Discontinuation = Failure). Analysis was performed using a stratified analysis with CMH weights, adjusting for Baseline plasma HIV-1 RNA ( =<vs. >100,000 c/mL) and CD4+ cell count (=<350 cells/mm^3 or >350 cells/mm^3). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population.|Week 48|ITT-E Population||Percentage of participants|||Number
658003|NCT01910402|Secondary|Change From Baseline in Lipase at Indicated Timepoints.|Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in lipase is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 4, 12, 24, 36, 48|Safety Population||Units per liter||Standard Deviation|Mean
657984|NCT01910402|Secondary|Assessment of HIVTSQs Total Score at Indicated Timepoints.|The HIV treatment satisfaction questionnaire (HIVTSQ) is a 10-item self-reported scale that measures overall satisfaction with treatment and by specific domains e.g. convenience, flexibility. The HIVTSQ items are summed up to produce a treatment satisfaction score (0 to 60) and an individual satisfaction rating for each item (0 to 6) and two subscales: general satisfaction/clinical and lifestyle/ease subscales. The higher the score, the greater the improvement in treatment satisfaction as compared to the past few weeks. A smaller score represents a decline in treatment satisfaction compared to the past few weeks. Statistical analysis was performed based on Wilcoxon rank sum test. Only those participants available at the specified time points (represented by n=X, X in the category titles) were analyzed.|Week 4, 12, 24, 48|ITT-E Population||Score on a scale||Standard Deviation|Mean
657985|NCT01910402|Secondary|Change From Baseline at Week 48 in SF-12 Total Score, MCS and PCS|The SF-12 is the 12 item abbreviated form of SF-36 survey. It provides information about how participants feel, and how well they have been able to perform their usual activities. SF-12 questions make up 8 scales: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, Mental Health . Transformed physical component summary score (PCS) and transformed mental component summary score (MCS) are derived using the sum of all 12 items and scored onto a 0-100 scale such that a higher score indicates a better health state and better functioning. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points (represented by n=X, X in the category titles) were analyzed.|Baseline and Week 48|ITT-E Population||Score on a scale||Standard Deviation|Mean
657986|NCT01910402|Secondary|Bone Specific Alkaline Phosphatase, Osteocalcin, Procollagen 1 N-terminal Propeptide, Type 1 Collagen C-Telopeptide, Vitamin D Ratio of Week 48 Results Over Baseline|Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Bone specific alkaline phosphatase (BSAP), osteocalcin and procollagen 1 N-terminal propeptide (PTP), Type 1 Collagen C-Telopeptide, vitamin D ratio of Week 48 results over Baseline is calculated. Bone biomarkers were analysed based on log transformed data. Only those participants available at the specified time points (represented by n=X, X in the category titles) were analyzed. Estimates of adjusted mean and difference were calculated from an ANCOVA model adjusting for age, baseline viral load Baseline CD4+ cell count, Baseline biomarker level, body mass index category, smoking status and baseline Vitamin D use. Adjusted mean of log-transformed change from Baseline are transformed back to Week 48/Baseline ratio for each treatment group. Adjusted difference of log-transformed change from Baseline between treatment groups is transformed back to the ratio of Week 48/Baseline ratio in DTG/ABC/3TC FDC to ATV+RTV+TDF/FTC FDC.|Baseline, Weeks 24, 48|Safety Population.||Ratio||95% Confidence Interval|Number
657987|NCT01910402|Secondary|Change From Baseline in Vitamin D, Vitamin D2 and Vitamin D3 at Week 24 and Week 48|Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Change from Baseline in vitamin D and vitamin D2 is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points (represented by n=X, X in the category titles) were analyzed.|Baseline, Weeks 24, 48|Safety Population||Nanomoles per liter||Standard Deviation|Mean
657988|NCT01910402|Secondary|Change From Baseline in Type I Collagen C-telopeptides at Indicated Timepoints|Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Change from Baseline in Type I collagen C-telopeptides (T-1 CCT) is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points (represented by n=X, X in the category titles) were analyzed.|Baseline, Week 24, 48|Safety Population||Nanograms per liter||Standard Deviation|Mean
657989|NCT01910402|Secondary|Change From Baseline in Bone Specific Alkaline Phosphatase, Osteocalcin and Procollagen 1 N-terminal Propeptide at Indicated Timepoints|Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Change from Baseline in bone specific alkaline phosphatase (BSAP), osteocalcin and procollagen 1 N-terminal propeptide (PTP) is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points (represented by n=X, X in the category titles) were analyzed.|Baseline, Week 24, 48|Safety Population||Micrograms per liter||Standard Deviation|Mean
657990|NCT01910402|Secondary|Number of Participants Who Withdrew From Treatment Due to AEs|An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an MP. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or is associated with liver injury and impaired liver function.|average of 354 days for DTG/ABC/3TC, and average of 336 days for ATV+RTV+TDF/FTC|Safety Population||Participants|||Number
657991|NCT01910402|Secondary|Summary of Maximum Post-Baseline Emergent Hematology Toxicities|Number of participants with Grade 1-4 emergent hematology toxicities were assessed from the start of study treatment and until the follow up contact. Hematology toxicities were categorized into following grades as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe Grade 4- potentially life-threatening.|Average of 354 days for DTG/ABC/3TC, and average of 336 days for ATV+RTV+TDF/FTC|Safety Population||Participants|||Number
657992|NCT01910402|Secondary|Summary of Maximum Post-Baseline Emergent Chemistry Toxicities|Number of participants with Grade 1-4 emergent chemistry toxicities were assessed from the start of study treatment and until the follow up contact. Chemistry toxicities were categorized into following grades as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe Grade 4- potentially life-threatening.|Average of 354 days for DTG/ABC/3TC, and average of 336 days for ATV+RTV+TDF/FTC|Safety Population||Participants|||Number
657993|NCT01910402|Secondary|Number of Participants With Any Adverse Events (AEs), and Serious Adverse Events (SAEs)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or other events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcome listed above, liver injury and impaired liver function and grade 4 laboratory abnormalities. Number of participants with any AEs, and SAEs have been presented.|From start of IP through the Study Phase (Average of 354 days for DTG/ABC/3TC, and average of 336 days for ATV+RTV+TDF/FTC)|Safety Population||Participants|||Number
657994|NCT01910402|Secondary|Summary of AEs by Maximum Toxicity as Per DAIDS AE Grading Table.|Number of participants with Grade 1-4 AEs were assessed from the start of study treatment and until end of the Randimization phase. AEs are categorized into following grades as per The Division of Aqcuired Immuno Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe Grade 4- potentially life-threatening.|Average of 354 days for DTG/ABC/3TC, and average of 336 days for ATV+RTV+TDF/FTC|Safety Population||Participants|||Number
657995|NCT01910402|Secondary|Change From Baseline in Urine Albumin Creatinine Ratio at Indicated Time Points|Change from Baseline in urine albumin creatinine ratio at Week 24 and Week 48 is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed.|Baseline, Week 24, Week 48|Safety Population||milligrams per millimole||Standard Deviation|Mean
657996|NCT01910402|Secondary|Change From Baseline in TC/HDL Ratio at Week 48|Change from Baseline in mean total cholesterol (TC)/HDL ratio is summarized at Week 48. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean is the estimated mean change from Baseline in fasted TC/HDL at Week 48 in each arm calculated from a model adjusted for the following covariates: treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age and triglycerides/HDL at Baseline. Subjects on lipid lowering therapy at baseline were excluded from analysis. Measurements collected after a subject initiates lipid lowering therapy were set to missing. Missing values were imputed using multiple imputation under a multivariate normal model adjusting for Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, fasted triglycerides and TC/HDL ratio at Baseline, Week 12 and Week 36.|Baseline and Week 48|Safety Population. Subjects on lipid lowering therapy at baseline were excluded from analysis.||Ratio||Standard Error|Least Squares Mean
657997|NCT01910402|Secondary|Change From Baseline in Triglycerides at Week 48|Change from Baseline in mean triglycerides is summarized at Week 48. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean is the estimated mean change from Baseline in fasted triglycerides at Week 48 in each arm calculated from a model adjusted for the following covariates: treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age and triglycerides at Baseline. Subjects on lipid lowering therapy at baseline were excluded from analysis. Measurements collected after a subject initiates lipid lowering therapy were set to missing. Missing values were imputed using multiple imputation under a multivariate normal model adjusting for Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, fasted triglycerides and TC/HDL ratio at Baseline, Week 12 and Week 36.|Baseline and Week 48|Safety Population. Subjects on lipid lowering therapy at baseline were excluded from analysis.||Millimoles per liter||Standard Error|Least Squares Mean
657998|NCT01910402|Secondary|Change From Baseline in Erythrocyte Mean Corpuscular Volume at Indicated Time Points.|Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in erythrocyte mean corpuscular volume (EMCV) is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 4, 12, 24, 36, 48|Safety Population||Femtoliter||Standard Deviation|Mean
657999|NCT01910402|Secondary|Change From Baseline in Hematocrit Count at Indicated Time Points.|Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in hematocrit is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 4, 12, 24, 36, 48|Safety Population||Fraction of 1||Standard Deviation|Mean
658000|NCT01910402|Secondary|Change From Baseline in Erythrocytes at Indicated Time Points.|Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in erythrocytes is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 4, 12, 24, 36, 48|Safety Population||10^12 per liter||Standard Deviation|Mean
658001|NCT01910402|Secondary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points|Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in basophils, eosinophils, lymphocytes, monocytes is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 4, 12, 24, 36, 48|Safety Population||10^9 cells per liter||Standard Deviation|Mean
658002|NCT01910402|Secondary|Change From Baseline in Total CHLS/HDL CHLS Ratio at Indicated Timepoints.|Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in Total CHLS/HDL CHLS ratio is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 4, 12, 24, 36, 48|Safety Population||Ratio||Standard Deviation|Mean
658004|NCT01910402|Secondary|Change From Baseline in Creatinine Clearance at Indicated Time Points|Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in creatinine clearance is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 4, 12, 24, 36, 48|Safety Population||Milliliter per minute||Standard Deviation|Mean
658005|NCT01910402|Secondary|Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points|Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, creatine kinase is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 4, 12, 24, 36, 48|Safety Population||International units per liter||Standard Deviation|Mean
658006|NCT01910402|Secondary|Change From Baseline in Albumin at Indicated Timepoints.|Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in albumin is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 4, 12, 24, 36, 48|Safety Population||Grams per liter||Standard Deviation|Mean
658007|NCT01910402|Secondary|Change From Baseline in Bilirubin and Creatinine at Indicated Timepoints.|Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in bilirubin and creatinine are summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 4, 12, 24, 36, 48|Safety Population||Micromoles per liter||Standard Deviation|Mean
658008|NCT01910402|Secondary|Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points|Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in carbon dioxide, electrolytes (chloride, hyperkalemia, hypernatremia, hypokalemia, hyponatremia, phosphate, potassium, sodium), lipids (cholesterol [CHLS], high density lipoprotein [HDL] CHLS direct, low density lipoprotein (LDL) CHLS calculation, LDL CHLS direct, triglycerides), glucose (hyperglycaemia, hypoglycaemia) and urea are summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Laboratory parameters were assessed in Safety Population which comprised of all participants who received at least one dose of study treatment. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 4, 12, 24, 36, 48|"Safety Population. A value of 99999 indicates where no data is available or not able to determine the value."||Millimoles per liter||Standard Deviation|Mean
658009|NCT01910402|Secondary|Change From Baseline in CD4+ Cell Count at Indicated Timepoints|Change from Baseline in cluster of differentiation 4(CD4+) cell count were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48|ITT-E Population||Cells per millimeter cube||Standard Deviation|Mean
658010|NCT01910402|Secondary|Change From Baseline in Plasma HIV-1 RNA at Indicated Time Points|Change from the Baseline in plasma HIV-1 RNA were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48|ITT-E Population||Log10 copies/mL||Standard Deviation|Mean
658011|NCT01910402|Secondary|Percentage of Participants With Plasma HIV-1 RNA <50 and <400 c/mL Over Time|Percentage of participants with plasma HIV-1 RNA <50 and <400 c/mL were assessed at Baseline, Week 4, 12, 24 , 36 and Week 48 using the Snapshot algorithm (Missing, Switch or Discontinuation = Failure). The Baseline value was defined as the latest pre-dose assessment (Day 1) value.|Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48|ITT-E Population||Percentage of participants|||Number
658012|NCT01910402|Primary|Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48|Percentage of participants with plasma human immunodeficiency virus type 1(HIV-1) ribonucleic acid (RNA) <50 copies per milliliter (c/mL) were assessed at Week 48 using the Snapshot algorithm. Analysis was performed using a stratified analysis with Cochran-Mantel-Haenszel (CMH) weights, adjusting for Baseline plasma HIV-1 RNA ( =<vs. >100,000 c/mL) and CD4+ cell count (=<350 cells per millimetre cube (cells/mm^3) or >350 cells/mm^3). Intent-to-Treat Exposed (ITT-E) Population comprised of all randomised participants who received at least one dose of study medication.|Week 48|ITT-E Population||Percentage of participants|||Number
658013|NCT01910389|Secondary|Trend in Minnesota Living With Heart Failure Questionnaire (MLHFQ) Score From Baseline Through 18 Months||Randomization to 18 months|Trial was terminated early. Data for outcome not obtained.|||||
658014|NCT01910389|Secondary|Change in Minnesota Living With Heart Failure Questionnaire (MLHFQ) Score From Baseline to 18 Months||Randomization to 18 months|Trial was terminated early. Data for outcome not obtained.|||||
658015|NCT01910389|Secondary|Trend in 6 Minute Walk Distance From Baseline Through 18 Months||Randomization to 18 months|Trial was terminated early. Data for outcome not obtained.|||||
658016|NCT01910389|Secondary|Change in 6 Minute Walk Distance From Baseline to 18 Months||Randomization to 18 months|Trial was terminated early. Data for outcome not obtained.|||||
658017|NCT01910389|Secondary|Change in MLHFQ Score From Baseline to 3 Months||Randomization to 3 months|Trial was terminated early. Data for outcome not obtained.|||||
658018|NCT01910389|Secondary|Change in 6 Minute Walk Distance From Baseline to 3 Months||Randomization to 3 months|Trial was terminated early. Data for outcome not obtained.|||||
658021|NCT01910389|Secondary|Composite Outcome of All-cause Mortality or CV Hospitalization (Myocardial Infarction, Acute Coronary Syndrome, Stroke, Arrhythmia, or Heart Failure)||Randomization through each subject's last semi-annual visit, up to a maximum of 3 years per subject|Trial was terminated early. Data for outcome not obtained.|||||
658022|NCT01910389|Secondary|All-cause Mortality||Randomization through each subject's last semi-annual visit, up to a maximum of 3 years per subject|Trial was terminated early. Data for outcome not obtained.|||||
658023|NCT01910389|Secondary|Heart Failure Hospitalization||Randomization through each subject's last semi-annual visit, up to a maximum of 3 years per subject|Trial was terminated early. Data for outcome not obtained.|||||
658024|NCT01910389|Secondary|Cardiovascular Mortality||Randomization through each subject's last semi-annual visit, up to a maximum of 3 years per subject|Trial was terminated early. Data for outcome not obtained.|||||
658025|NCT01910389|Primary|Composite Outcome of Cardiovascular (CV) Mortality or Heart Failure (HF) Hospitalization||Randomization through each subject's last semi-annual visit, up to a maximum of 3 years per subject|Trial was terminated early. Data for outcome not obtained.|||||
658026|NCT01910311|Primary|PK: Time of Maximum Observed Drug Concentration (Tmax) of Baricitinib||Period 1, Day 1 and Period 2, Day 10: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose|Participants who received study drug (baricitinib in Period 1 and at least 1 dose of rifampicin and baricitinib in Period 2) and who had evaluable PK data.||hours (h)||Full Range|Median
658027|NCT01910311|Primary|PK: Area Under the Concentration Versus Time Curve From 0 to Infinity [AUC(0-∞)] of Baricitinib||Period 1, Day 1 and Period 2, Day 10: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose|Participants who received study drug (baricitinib in Period 1 and at least 1 dose of rifampicin and baricitinib in Period 2) and had evaluable PK data.||nanograms*hour/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
658028|NCT01910311|Primary|PK: Maximum Concentration (Cmax) of Baricitinib||Period 1, Day 1 and Period 2, Day 10: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose|Participants who received study drug (baricitinib in Period 1 and at least 1 dose of rifampicin and baricitinib in Period 2) and had evaluable PK data.||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
658029|NCT01910181|Secondary|Overall Survival (OS)|OS was defined as the time from treatment start to death from any cause. Median time to event was estimated using Kaplan-Meier analysis, and the 95% CI was estimated using the Brookmeyer-Crowley method.|Throughout treatment (up to 16 months); survival followed every 3 months until discontinuation from study (up to 16 months as of data cutoff 15-Dec-2014)|Safety Population.||months||95% Confidence Interval|Median
658030|NCT01910181|Secondary|Percentage of Participants Who Died|The percentage of participants who died during the study was reported.|Throughout treatment (up to 16 months); survival followed every 3 months until discontinuation from study (up to 16 months as of data cutoff 15-Dec-2014)|Safety Population.||percentage of participants|||Number
658031|NCT01910181|Secondary|Progression-Free Survival (PFS)|Tumor response was evaluated using RECIST version 1.1 criteria. Disease progression was defined as ≥20% increase on-study in sum diameter of target lesions with absolute increase ≥5 mm, or the appearance of new lesion(s). PFS was defined as the time from treatment start to the first event of disease progression or death. Median time to event was estimated using Kaplan-Meier analysis, and the 95% CI was estimated using the Brookmeyer-Crowley method.|Tumor assessments at Screening, Day 1 of Cycle 3, and every two cycles (cycle length of 28 days) thereafter until disease progression; survival followed every 3 months until discontinuation from study (up to 16 months as of data cutoff 15-Dec-2014)|Safety Population.||months||95% Confidence Interval|Median
658032|NCT01910181|Secondary|Percentage of Participants With Death or Disease Progression According to RECIST Version 1.1|Tumor response was evaluated using RECIST version 1.1 criteria. Disease progression was defined as ≥20% increase on-study in sum diameter of target lesions with absolute increase ≥5 mm, or the appearance of new lesion(s). The percentage of participants with death or disease progression during the study was reported.|Tumor assessments at Screening, Day 1 of Cycle 3, and every two cycles (cycle length of 28 days) thereafter until disease progression; survival followed every 3 months until discontinuation from study (up to 16 months as of data cutoff 15-Dec-2014)|Safety Population.||percentage of participants|||Number
658033|NCT01910181|Secondary|Duration of Response According to RECIST Version 1.1|Tumor response was evaluated using RECIST version 1.1 criteria. CR was defined as disappearance of all target lesions and short-axis reduction of any pathological lymph nodes to <10 mm. PR was defined as ≥30) decrease from Baseline in sum diameter of target lesions. Disease progression was defined as ≥20% increase on-study in sum diameter of target lesions with absolute increase ≥5 mm, or the appearance of new lesion(s). Duration of response was defined as the time from initial response of CR or PR to the first event of disease progression or death. Median time to event was estimated using Kaplan-Meier analysis, and the 95% confidence interval (CI) was estimated using the Brookmeyer-Crowley method.|Tumor assessments at Screening, Day 1 of Cycle 3, and every two cycles (cycle length of 28 days) thereafter until disease progression; survival followed every 3 months until discontinuation from study (up to 16 months as of data cutoff 15-Dec-2014)|Safety Population; only participants with a previous response (assessment of CR or PR) were included.||months||95% Confidence Interval|Median
658034|NCT01910181|Secondary|Percentage of Participants With Disease Progression or Death Among Participants With a Previous Assessment of CR or PR According to RECIST Version 1.1|Tumor response was evaluated using RECIST version 1.1 criteria. CR was defined as disappearance of all target lesions and short-axis reduction of any pathological lymph nodes to <10 mm. PR was defined as ≥30) decrease from Baseline in sum diameter of target lesions. Disease progression was defined as ≥20% increase on-study in sum diameter of target lesions with absolute increase ≥5 mm, or the appearance of new lesion(s). The percentage of participants who died or progressed after CR or PR was reported.|Tumor assessments at Screening, Day 1 of Cycle 3, and every two cycles (cycle length of 28 days) thereafter until disease progression; survival followed every 3 months until discontinuation from study (up to 16 months as of data cutoff 15-Dec-2014)|Safety Population; only participants with a previous response (assessment of CR or PR) were included.||percentage of participants|||Number
658227|NCT01907906|Secondary|Neoantigenicity - Day 42 Direct Antigen Test (DAT)|DAT testing of RBCs via Anti-IgG and Anti-C3 as derived from Mirasol-treated WB versus untreated WB. Number of positive results (indicating a new antigen formation) were recorded.|Day 42 of Treatment Periods 1 and 2|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test||Positive results|||Number
658035|NCT01910181|Secondary|Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1|Tumor response was evaluated using RECIST version 1.1 criteria. CR was defined as disappearance of all target lesions and short-axis reduction of any pathological lymph nodes to less than (<) 10 millimeters (mm). PR was defined as greater than or equal to (≥) 30 percent (%) decrease from Baseline in sum diameter of target lesions. The percentage of participants with a best overall response of CR or PR during the study was reported.|Tumor assessments at Screening, Day 1 of Cycle 3, and every two cycles (cycle length of 28 days) thereafter until disease progression (up to 16 months as of data cutoff 15-Dec-2014)|Safety Population.||percentage of participants||95% Confidence Interval|Number
658036|NCT01910181|Primary|Terminal Elimination Rate Constant (Kel) of RO5185426 on Day 21|Plasma PK samples were obtained from each participant and the kel was estimated. The value was averaged among all participants and expressed in inverse hours (h^-1).|Pre-dose (0 hours) and post-dose (1, 2, 4, 5, 8, 12, 24, 28, 72, 76, 168 hours) from Day 21|PK Population; only participants who provided sufficient data for the designated timeframe/visit were included.||hours^-1||Standard Deviation|Mean
658037|NCT01910181|Primary|Accumulation Ratio of RO5185426 AUC From 0 to 8 Hours Between Day 21 and Day 1|Plasma PK samples were obtained from each participant for calculation of AUC from 0 to 8 hours, using the linear trapezoid rule. The AUC on Day 21 was divided by the AUC for Day 1. The resulting value was averaged among all participants and expressed as the accumulation ratio.|Pre-dose (0 hours) and post-dose (1, 2, 4, 5, 8 hours) on Days 1 and 21|PK Population; only participants who provided sufficient data for the designated timeframe/visit were included.||accumulation ratio||Standard Deviation|Mean
658038|NCT01910181|Primary|Ctrough of RO5185426 on Day 21|Plasma PK samples were obtained from each participant, and the concentration immediately prior to drug administration was recorded. The value was averaged among all participants and expressed in μg/mL.|Pre-dose (0 hours) on Day 21|PK Population; only participants who provided sufficient data for the designated timeframe/visit were included.||μg/mL||Standard Deviation|Mean
658039|NCT01910181|Primary|Ctrough of RO5185426 on Day 19|Plasma PK samples were obtained from each participant, and the concentration immediately prior to drug administration was recorded. The value was averaged among all participants and expressed in μg/mL.|Pre-dose (0 hours) on Day 19|PK Population; only participants who provided sufficient data for the designated timeframe/visit were included.||μg/mL||Standard Deviation|Mean
658040|NCT01910181|Primary|Trough Plasma Concentration (Ctrough) of RO5185426 on Day 15|Plasma PK samples were obtained from each participant, and the concentration immediately prior to drug administration was recorded. The value was averaged among all participants and expressed in μg/mL.|Pre-dose (0 hours) on Day 15|PK Population; only participants who provided sufficient data for the designated timeframe/visit were included.||μg/mL||Standard Deviation|Mean
658041|NCT01910181|Primary|Elimination Half-Life (t1/2) of RO5185426 Following Day 21 Dose|Plasma PK samples were obtained from each participant for calculation of t1/2, defined as the time elapsed for plasma concentrations to drop by half. The value was averaged among all participants and expressed in hours.|Pre-dose (0 hours) and post-dose (1, 2, 4, 5, 8, 12, 24, 28, 72, 76, 168 hours) from Day 21|PK Population; only participants who provided sufficient data for the designated timeframe/visit were included.||hours||Standard Deviation|Mean
658042|NCT01910181|Primary|AUC From 0 to 168 Hours of RO5185426 Following Day 21 Dose|Plasma PK samples were obtained from each participant for calculation of AUC from 0 to 168 hours, using the linear trapezoid rule. The value was averaged among all participants and expressed in h*μg/mL.|Pre-dose (0 hours) and post-dose (1, 2, 4, 5, 8, 12, 24, 28, 72, 76, 168 hours) from Day 21|PK Population; only participants who provided sufficient data for the designated timeframe/visit were included.||h*μg/mL||Standard Deviation|Mean
658043|NCT01910181|Primary|Tmax of RO5185426 Following Day 21 Dose|Plasma PK samples were obtained from each participant, and the time of maximum post-dose concentration was recorded. The median value was derived from all participants and expressed in hours.|Pre-dose (0 hours) and post-dose (1, 2, 4, 5, 8, 12, 24, 28, 72, 76, 168 hours) from Day 21|PK Population; only participants who provided sufficient data for the designated timeframe/visit were included.||hours||Full Range|Median
658044|NCT01910181|Primary|Time of Maximum Plasma Concentration (Tmax) of RO5185426 on Day 1|Plasma PK samples were obtained from each participant, and the time of maximum post-dose concentration was recorded. The median value was derived from all participants and expressed in hours.|Pre-dose (0 hours) and post-dose (1, 2, 4, 5, 8, 12 hours) on Day 1|PK Population.||hours||Full Range|Median
658045|NCT01910181|Primary|Cmax of RO5185426 Following Day 21 Dose|Plasma PK samples were obtained from each participant, and the maximum observed post-dose concentration was recorded. The value was averaged among all participants and expressed in μg/mL.|Pre-dose (0 hours) and post-dose (1, 2, 4, 5, 8, 12, 24, 28, 72, 76, 168 hours) from Day 21|PK Population; only participants who provided sufficient data for the designated timeframe/visit were included.||μg/mL||Standard Deviation|Mean
658046|NCT01910181|Primary|Maximum Plasma Concentration (Cmax) of RO5185426 on Day 1|Plasma PK samples were obtained from each participant, and the maximum observed post-dose concentration was recorded. The value was averaged among all participants and expressed in micrograms per milliliter (μg/mL).|Pre-dose (0 hours) and post-dose (1, 2, 4, 5, 8, 12 hours) on Day 1|PK Population.||μg/mL||Standard Deviation|Mean
658047|NCT01910181|Primary|AUC of RO5185426 From 0 to 12 Hours on Day 21|Plasma PK samples were obtained from each participant for calculation of AUC from 0 to 12 hours, using the linear trapezoid rule. The value was averaged among all participants and expressed in h*μg/mL.|Pre-dose (0 hours) and post-dose (1, 2, 4, 5, 8, 12 hours) on Day 21|PK Population; only participants who provided sufficient data for the designated timeframe/visit were included.||h*μg/mL||Standard Deviation|Mean
658048|NCT01910181|Primary|AUC of RO5185426 From 0 to 12 Hours on Day 1|Plasma PK samples were obtained from each participant for calculation of AUC from 0 to 12 hours, using the linear trapezoid rule. The value was averaged among all participants and expressed in h*μg/mL.|Pre-dose (0 hours) and post-dose (1, 2, 4, 5, 8, 12 hours) on Day 1|PK Population; only participants who provided sufficient data for the designated timeframe/visit were included.||h*μg/mL||Standard Deviation|Mean
658240|NCT01907854|Secondary|Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) (American Diabetes Association Target) (y/n)|Number of subjects who achieve HbA1c <7.0% were analysed after 26 weeks of treatment. Missing values were imputed using MMRM.|After 26 weeks of treatment|FAS-All randomised subjects receiving at least one dose of any of the trial product.||percentage (%)|||Number
658049|NCT01910181|Primary|AUC of RO5185426 From 0 to 8 Hours on Day 21|Plasma PK samples were obtained from each participant for calculation of AUC from 0 to 8 hours, using the linear trapezoid rule. The value was averaged among all participants and expressed in h*μg/mL.|Pre-dose (0 hours) and post-dose (1, 2, 4, 5, 8 hours) on Day 21|PK Population; only participants who provided sufficient data for the designated timeframe/visit were included.||h*μg/mL||Standard Deviation|Mean
658050|NCT01910181|Primary|Area Under the Plasma Concentration-Time Curve (AUC) of RO5185426 From 0 to 8 Hours on Day 1|Plasma PK samples were obtained from each participant for calculation of AUC from 0 to 8 hours, using the linear trapezoid rule. The value was averaged among all participants and expressed in hours by micrograms per milliliter (h*μg/mL).|Pre-dose (0 hours) and post-dose (1, 2, 4, 5, 8 hours) on Day 1|PK Population: All participants who provided evaluable data for PK analysis and did not have a significant protocol violation/deviation.||h*μg/mL||Standard Deviation|Mean
658051|NCT01910116|Secondary|Number of OMERACT-OARSI Responder|Number of patients who met OMERACT-OARSI criteria = significant clinical improvement in osteoarthritis symptom after treatment|Baselie and 16 weeks|||participants|||Number
658052|NCT01910116|Secondary|Number of OMERACT-OARSI Responder|Number of patients who met OMERACT-OARSI criteria = significant clinical improvement in osteoarthritis symptom after treatment|Baseline and 12 weeks|||participants|||Number
658053|NCT01910116|Secondary|Number of OMERACT-OARSI Responder|Number of patients who met OMERACT-OARSI criteria = significant clinical improvement in osteoarthritis symptom after treatment|Baseline and 8 weeks|||participants|||Number
658054|NCT01910116|Secondary|Number of OMERACT-OARSI Responder|Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Number of patients who met OMERACT-OARSI criteria = significant clinical improvement in osteoarthritis symptom after treatment|Baseline and 4 weeks|||participants|||Number
658055|NCT01910116|Secondary|Acetaminophen Rescue|yes = AAP rescue use, no = no AAP rescue use|12 weeks and 16 weeks|||participants|||Number
658056|NCT01910116|Secondary|Acetaminophen Rescue|yes = AAP rescue use, no = no AAP rescue use|8 weeks and 12 weeks|||participants|||Number
658057|NCT01910116|Secondary|Acetaminophen Rescue|yes = AAP rescue use, no = no AAP rescue use|4 weeks and 8 weeks|||participants|||Number
658058|NCT01910116|Secondary|Acetaminophen Rescue|yes = AAP rescue use, no = no AAP rescue use|Baseline 4 weeks|||participants|||Number
658059|NCT01910116|Secondary|Swollen Joint Count, Change From Baseline|"Change in Swollen joint count (SJC) at 16 weeks from baseline = SJC at 16 weeks - TJC at baseline..
Negative value means improvement from baseline
Positive value means deterioration from baseline"|Baseline and 16 weeks|||Joints||Inter-Quartile Range|Median
658060|NCT01910116|Secondary|Swollen Joint Count, Change From Baseline|"Change in Swollen joint count (SJC) at 12 weeks from baseline = SJC at 12 weeks - TJC at baseline..
Negative value means improvement from baseline
Positive value means deterioration from baseline"|Baseline and 12 weeks|||Joints||Inter-Quartile Range|Median
658061|NCT01910116|Secondary|Swollen Joint Count, Change From Baseline|"Change in Swollen joint count (SJC) at 8 weeks from baseline = SJC at 8 weeks - TJC at baseline..
Negative value means improvement from baseline
Positive value means deterioration from baseline"|Baseline and 8 weeks|||Joints||Inter-Quartile Range|Median
658062|NCT01910116|Secondary|Swollen Joint Count, Change From Baseline|"Change in Swollen joint count (SJC) at 4 weeks from baseline = SJC at 4 weeks - TJC at baseline..
Negative value means improvement from baseline
Positive value means deterioration from baseline"|Baseline and 4 weeks|||Joints||Inter-Quartile Range|Median
658063|NCT01910116|Secondary|Tender Joint Count, Change From Baseline|"Change in Tender joint count (TJC) at 16 weeks from baseline = TJC at 16 weeks - TJC at baseline..
Negative value means improvement from baseline
Positive value means deterioration from baseline"|Baseline and 16 weeks|||joints||Inter-Quartile Range|Median
658064|NCT01910116|Secondary|Tender Joint Count, Change From Baseline|"Change in Tender joint count (TJC) at 12 weeks from baseline = TJC at 12 weeks - TJC at baseline..
Negative value means improvement from baseline
Positive value means deterioration from baseline"|Baseline and 12 weeks|||joints||Inter-Quartile Range|Median
658065|NCT01910116|Secondary|Tender Joint Count, Change From Baseline|"Change in Tender joint count (TJC) at 8 weeks from baseline = TJC at 8 weeks - TJC at baseline..
Negative value means improvement from baseline
Positive value means deterioration from baseline"|Baseline and 8 weeks|||Joints||Inter-Quartile Range|Median
658066|NCT01910116|Secondary|Tender Joint Count, Change From Baseline|"Change in Tender joint count (TJC) at 4 weeks from baseline = TJC at 4 weeks - TJC at baseline..
Negative value means improvement from baseline
Positive value means deterioration from baseline"|Baseline and 4 weeks|||joints||Inter-Quartile Range|Median
658067|NCT01910116|Secondary|Physician Global Assessment, Change From Baseline|"Change in Physician global assessment (PhGA) at 16 weeks from baseline = PhGA at 16 weeks (0-100)- PhGA score at baseline (0-100). PhGA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition).
Negative value means improvement from baseline
Positive value means deterioration from baseline"|Baseline and 16 weeks|||units on a scale||Inter-Quartile Range|Median
658068|NCT01910116|Secondary|Physician Global Assessment, Change From Baseline|"Change in Physician global assessment (PhGA) at 12 weeks from baseline = PhGA at 12 weeks (0-100)- PhGA score at baseline (0-100). PhGA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition).
Negative value means improvement from baseline
Positive value means deterioration from baseline"|Baseline and 12 weeks|||units on a scale||Inter-Quartile Range|Median
658069|NCT01910116|Secondary|Physician Global Assessment, Change From Baseline|"Change in Physician global assessment (PhGA) at 8 weeks from baseline = PhGA at 8 weeks (0-100)- PhGA score at baseline (0-100). PhGA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition).
Negative value means improvement from baseline
Positive value means deterioration from baseline"|Baseline and 8 weeks|||units on a scale||Inter-Quartile Range|Median
658070|NCT01910116|Secondary|Physician Global Assessment, Change From Baseline|"Change in Physician global assessment (PhGA) at 4 weeks from baseline = PhGA at 4 weeks (0-100)- PhGA score at baseline (0-100). GPA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition).
Negative value means improvement from baseline
Positive value means deterioration from baseline"|baseline and 4 weeks|||units on a scale||Inter-Quartile Range|Median
658407|NCT01903148|Primary|% Patients Achieving Target Hemoglobin Levels|% patients with Hb levels between 11-12 mg/dl|1 day because is a crosssectional study with only a visit|||percentage of participants|||Number
658071|NCT01910116|Secondary|Patient Global Assessment, Change From Baseline|"Change in Patient global assessment (PGA) at 16 weeks from baseline = PGA at 16 weeks (0-100)- PGA score at baseline (0-100). PGA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition).
Negative value means improvement from baseline
Positive value means deterioration from baseline"|Baseline and 16 weeks|||units on a scale||Inter-Quartile Range|Median
658072|NCT01910116|Secondary|Patient Global Assessment, Change From Baseline|"Change in Patient global assessment (PGA) at 12 weeks from baseline = PGA at 12 weeks (0-100)- PGA score at baseline (0-100). GPA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition).
Negative value means improvement from baseline
Positive value means deterioration from baseline"|Baseline and 12 weeks|||units on a scale||Inter-Quartile Range|Median
658073|NCT01910116|Secondary|Patient Global Assessment, Change From Baseline|"Change in Patient global assessment (PGA) at 8 weeks from baseline = PGA at 8 weeks (0-100)- PGA score at baseline (0-100). PGA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition).
Negative value means improvement from baseline
Positive value means deterioration from baseline"|Baseline and 8 weeks|||units on a scale||Inter-Quartile Range|Median
658074|NCT01910116|Secondary|Patient Global Assessment, Change From Baseline|"Change in Patient global assessment (PGA) at 4 weeks from baseline = PGA at 4 weeks (0-100)- PGA score at baseline (0-100). PGA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition).
Negative value means improvement from baseline
Positive value means deterioration from baseline"|Baseline and 4 weeks|||units on a scale||Inter-Quartile Range|Median
658075|NCT01910116|Secondary|AUSCAN Function Change at 16 Weeks From Baseline|"Change in AUSCAN function score at 16 weeks from baseline = Function score at 16 weeks (0-100)- Function score at baseline (0-100). AUSCAN Function score scale ranges from 0 (no functional limitation) to 100 (worst possible functional limitation).
Negative value means improvement from baseline
Positive value means deterioration from baseline"|Baseline and 16 weeks|||units on a scale||Inter-Quartile Range|Median
658076|NCT01910116|Secondary|AUSCAN Function Change at 12 Weeks From Baseline|"Change in AUSCAN function score at 12 weeks from baseline = Function score at 12 weeks (0-100)- Function score at baseline (0-100). AUSCAN Function score scale ranges from 0 (no functional limitation) to 100 (worst possible functional limitation).
Negative value means improvement from baseline
Positive value means deterioration from baseline"|Baseline and 12 weeks|||units on a scale||Inter-Quartile Range|Median
658077|NCT01910116|Secondary|AUSCAN Function Change at 8 Weeks From Baseline|"Change in AUSCAN function score at 8 weeks from baseline = Function score at 8 weeks (0-100)- Function score at baseline (0-100). AUSCAN Function score scale ranges from 0 (no functional limitation) to 100 (worst possible functional limitation).
Negative value means improvement from baseline
Positive value means deterioration from baseline"|Baseline and 8 weeks|||units on a scale||Inter-Quartile Range|Median
658078|NCT01910116|Secondary|AUSCAN Function Change at 4 Weeks From Baseline|"Change in AUSCAN function score at 4 weeks from baseline = Function score at 4 weeks (0-100)- Function score at baseline (0-100). AUSCAN Function score scale ranges from 0 (no functional limitation) to 100 (worst possible functional limitation).
Negative value means improvement from baseline
Positive value means deterioration from baseline"|Basline and 4 weeks|||units on a scale||Inter-Quartile Range|Median
658079|NCT01910116|Secondary|AUSCAN Stiffness at 16 Weeks Change From Baseline|"Change in AUSCAN stiffness score at 16 weeks from baseline = Stiffness at 16 weeks (0-100)- Stiffness at baseline (0-100). AUSCAN Stiffness scale ranges from 0 (no stiffness) to 100 (worst possible stiffness).
Negative value means improvement from baseline
Positive value means deterioration from baseline"|Baseline, 16 weeks|||units on a scale||Inter-Quartile Range|Median
658080|NCT01910116|Secondary|AUSCAN Stiffness at 12 Weeks Change From Baseline|"Change in AUSCAN stiffness score at 12 weeks from baseline = Stiffness at 12 weeks (0-100)- Stiffness at baseline (0-100). AUSCAN Stiffness scale ranges from 0 (no stiffness) to 100 (worst possible stiffness).
Negative value means improvement from baseline
Positive value means deterioration from baseline"|Basline and 12 weeks|||units on a scale||Inter-Quartile Range|Median
658081|NCT01910116|Secondary|AUSCAN Stiffness at 8 Weeks Change From Baseline|"Change in AUSCAN stiffness score at 8 weeks from baseline = Stiffness at 8 weeks (0-100)- Stiffness at baseline (0-100). AUSCAN Stiffness scale ranges from 0 (no stiffness) to 100 (worst possible stiffness).
Negative value means improvement from baseline
Positive value means deterioration from baseline"|baseline and 8 weeks|||units on a scale||Inter-Quartile Range|Median
658082|NCT01910116|Secondary|AUSCAN Stiffness at 4 Weeks Change From Baseline|"Change in AUSCAN stiffness score at 4 weeks from baseline = Stiffness at 4 weeks (0-100)- Stiffness at baseline (0-100). AUSCAN Stiffness scale ranges from 0 (no stiffness) to 100 (worst possible stiffness).
Negative value means improvement from baseline
Positive value means deterioration from baseline"|Baseline and 4 weeks|||units on a scale||Inter-Quartile Range|Median
658083|NCT01910116|Secondary|AUSCAN Pain Score at 16 Weeks From Baseline|"Change in AUSCAN pain score at 16 weeks from baseline = Pain at 16 weeks (0-100)- Pain at baseline (0-100). AUSCAN Pain scale ranges from 0 (no pain) to 100 (worst possible pain).
Negative value means improvement from baseline
Positive value means deterioration from baseline"|Baseline and 16 weeks|||units on a scale||Inter-Quartile Range|Median
658084|NCT01910116|Secondary|AUSCAN Pain Score at 12 Weeks From Baseline|"Change in AUSCAN pain score at 12 weeks from baseline = Pain at 12 weeks (0-100)- Pain at baseline (0-100). AUSCAN Pain scale ranges from 0 (no pain) to 100 (worst possible pain).
Negative value means improvement from baseline
Positive value means deterioration from baseline"|Baseline, 12 weeks|||units on a scale||Inter-Quartile Range|Median
658085|NCT01910116|Secondary|AUSCAN Pain Score at 8 Weeks From Baseline|"Change in AUSCAN pain score at 8 weeks from baseline = Pain at 8 weeks (0-100)- Pain at baseline (0-100). AUSCAN Pain scale ranges from 0 (no pain) to 100 (worst possible pain).
Negative value means improvement from baseline
Positive value means deterioration from baseline"|Baseline, 8 weeks|||units on a scale||Inter-Quartile Range|Median
658086|NCT01910116|Primary|AUSCAN Pain Change at 4 Weeks From Baseline|"Change in AUSCAN pain score at 4 weeks from baseline = Pain at 4 weeks (0-100) - Pain at baseline (0-100).
AUSCAN Pain scale ranges from 0 (no pain) to 100 (worst possible pain).
Negative value means improvement from baseline
Positive value means deterioration from baseline"|Baseline and 4 weeks|||units on a scale||Inter-Quartile Range|Median
658087|NCT01910064|Secondary|Percent Changes From Baseline in Total Lesion Counts||Baseline, Weeks 1, 2, 4, and Months 2, 3, 6, 9, 12|||percent change||Full Range|Median
658093|NCT01909804|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as:
On-treatment virologic failure:
Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)
Virologic relapse:
Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 24|Full Analysis Set||percentage of participants|||Number
658094|NCT01909804|Secondary|Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set||percentage of participants||95% Confidence Interval|Number
658095|NCT01909804|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 12 weeks|Safety Analysis Set||percentage of participants|||Number
658096|NCT01909804|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants randomized into the study and received at least 1 dose of study drug.||percentage of participants||95% Confidence Interval|Number
658097|NCT01909778|Secondary|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinanalysis and ECG|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinanalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.|from intake of the second dose Faldaprevir up to 9 days|Only one patient was treated and completed this study; he was the only patient analyzed.||participants|||Number
658098|NCT01909778|Secondary|Assessment of Tolerability by Investigator|The investigator has assessed tolerability based on adverse events and the laboratory evaluation. Tolerability was assessed by the investigator according to the categories 1=“good”, 2=“satisfactory”, 3=“not satisfactory”, and 4=“bad”.|Day 6 of period 1 and 2|Only one patient was treated and completed this study; he was the only patient analysed.||units on a scale|||Number
658099|NCT01909778|Secondary|MRTpo|Mean residence time of the analyte in the body after oral administration (MRTpo).|-0:15, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 8:00, 12:00, 16:00, 20:00, 24:00, 48:00, 72:00, 96:00, 120:00 h after drug administration on day 1 and day 15|Only one patient was treated and completed this study; he was the only patient analysed.||hours||Standard Deviation|Mean
658100|NCT01909778|Secondary|Vz/F|Apparent volume of distribution during the terminal phase (Vz/F) following an extravascular dose (at steady state).|-0:15, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 8:00, 12:00, 16:00, 20:00, 24:00, 48:00, 72:00, 96:00, 120:00 h after drug administration on day 1 and day 15|Only one patient was treated and completed this study; he was the only patient analysed.||Liter|||Number
658101|NCT01909778|Secondary|CL/F|"Apparent clearance of the analyte in plasma following extravascular administration (CL/F).
The apparent clearance after oral administration will be determined according to the following equation: CL or CL/F=dose/AUC0-∞. (F=absolute bioavailability factor)"|-0:15, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 8:00, 12:00, 16:00, 20:00, 24:00, 48:00, 72:00, 96:00, 120:00 h after drug administration on day 1 and day 15|Only one patient was treated and completed this study; he was the only patient analysed.||mL/min|||Number
658102|NCT01909778|Secondary|t1/2|Elimination half-life (t1/2). The terminal half-life will be calculated from the terminal rate constant.|-0:15, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 8:00, 12:00, 16:00, 20:00, 24:00, 48:00, 72:00, 96:00, 120:00 h after drug administration on day 1 and day 15|Only one patient was treated and completed this study; he was the only patient analysed.||hours|||Number
658103|NCT01909778|Secondary|AUC0-tz|Area under the concentration-time curve over the time interval from 0 to the last quantifiable plasma concentration (AUC0-tz).|-0:15, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 8:00, 12:00, 16:00, 20:00, 24:00, 48:00, 72:00, 96:00, 120:00 h after drug administration on day 1 and day 15|Only one patient was treated and completed this study; he was the only patient analysed.||h*ng/mL|||Number
658104|NCT01909778|Secondary|Tmax|Time at which the maximum plasma concentration occurs (tmax). Individual tmax values will be directly determined from the plasma concentration time profiles.|-0:15, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 8:00, 12:00, 16:00, 20:00, 24:00, 48:00, 72:00, 96:00, 120:00 h after drug administration on day 1 and day 15|Only one patient was treated and completed this study; he was the only patient analysed.||hours|||Number
658105|NCT01909778|Primary|Cmax|Maximum plasma concentration (Cmax). Individual Cmax values will be directly determined from the plasma concentration time profiles.|-0:15, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 8:00, 12:00, 16:00, 20:00, 24:00, 48:00, 72:00, 96:00, 120:00 h after drug administration on day 1 and day 15|Only one patient was treated and completed this study; he was the only patient analysed.||ng/mL|||Number
658106|NCT01909778|Primary|AUC 0-∞|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC 0-∞).|-0:15, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 8:00, 12:00, 16:00, 20:00, 24:00, 48:00, 72:00, 96:00, 120:00 h (hours) after drug administration on day 1 and day 15|Only one patient was treated and completed this study; he was the only patient analysed.||h*ng/mL|||Number
658107|NCT01909713|Secondary|Subject Satisfaction Questionnaire - Moisturizer|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the moisturizer at study end (day 22).|Day 22|||participants|||Number
658108|NCT01909713|Secondary|Subject Satisfaction Questionnaire - Face Wash|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the face wash at study end (day 22).|Day 22|||participants|||Number
658109|NCT01909713|Secondary|Hydration (Corneometry)|"Hydration was assessed using corneometry at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22). Corneometry measures the hydration status of the skin. An increase in corneometry values indicates an increase in the hydration status of the skin, and vice versa. The test is procedure specific, so results are reported in arbitrary units."|Week 3|||arbitrary units||Standard Deviation|Mean
658408|NCT01903005|Primary|Number of Patient Discontinuations Due to Treatment-Emergent Adverse Events|Study discontinuations due to treatment-emergent adverse events that occurred during treatment with bioavailability BNX sublingual tablets|Day 1 through week 24|Safety population||participants|||Number
658110|NCT01909713|Secondary|Barrier Function (TEWL)|Barrier function was assessed by measuring transepidermal water loss (TEWL) at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22). TEWL measures water loss through the epidermis (for example, by evaporation). Measuring TEWL is a well-established way to assess the skin’s water-barrier function. High TEWL values indicate impaired skin barrier function; low values indicate normal barrier function.|Week 3|||g/m2/h||Standard Deviation|Mean
658111|NCT01909713|Secondary|Cutaneous Tolerability Based on Subject and Parent/Legally Authorized Representative Interview - Tightness|Cutaneous tolerability based on visual inspection (investigator reported severity scale) was assessed at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22). Tightness: 0 = none, no tightness; 1 = mild, slight tightness, not really bothersome; 2 = moderate, definite tightness sensation that is somewhat bothersome; 3 = severe, tightness sensation that causes definite discomfort and may interrupt daily activities and/or sleep|Week 3|||participants|||Number
658112|NCT01909713|Secondary|Cutaneous Tolerability Based on Subject and Parent/Legally Authorized Representative Interview - Stinging|Cutaneous tolerability based on visual inspection (investigator reported severity scale) was assessed at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22). Stinging: 0 = none, no stinging; 1 = mild, slight stinging sensation, not really bothersome; 2 = moderate, definite stinging sensation that is somewhat bothersome; 3 = severe, stinging sensation that causes definite discomfort and may interrupt daily activities and/or sleep|Week 3|||participants|||Number
658113|NCT01909713|Secondary|Cutaneous Tolerability Based on Subject and Parent/Legally Authorized Representative Interview - Burning|Cutaneous tolerability based on visual inspection (investigator reported severity scale) was assessed at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22). Burning: 0 = none, no burning; 1 = mild, slight burning sensation, not really bothersome; 2 = moderate, definite warm, burning sensation that is somewhat bothersome; 3 = severe, hot burning sensation that causes definite discomfort and may interrupt daily activities and/or sleep|Week 3|||participants|||Number
658114|NCT01909713|Primary|Cutaneous Tolerability Based on Visual Inspection - Roughness|Cutaneous tolerability based on visual inspection (investigator reported severity scale) was assessed at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22). Roughness: 1 - no roughness, skin is fine, silky smooth, 2 - firm (not too rough, not too smooth), 3 - coarse, rough skin, 4 - leathery, flaky skin.|Week 3|||participants|||Number
658115|NCT01909713|Primary|Cutaneous Tolerability Based on Visual Inspection - Dryness|Cutaneous tolerability based on visual inspection (investigator reported severity scale) was assessed at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22). Dryness: 0 = no observable scaling; 1 = fine flakes/scaling; 2 = moderate flakes/scaling; 3 = larger flakes/severe scaling.|Week 3|||participants|||Number
658116|NCT01909713|Primary|Cutaneous Tolerability Based on Visual Inspection - Edema|Cutaneous tolerability based on visual inspection (investigator reported severity scale) was assessed at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22). Edema: 0 = none; 1 = mild; 2 = moderate; 3 = intense.|Week 3|||participants|||Number
658117|NCT01909713|Secondary|Cutaneous Tolerability Based on Subject and Parent/Legally Authorized Representative Interview - Itching|Cutaneous tolerability based on visual inspection (investigator reported severity scale) was assessed at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22). Itching: 0 = none, no itching; 1 = mild, slight itching, not really bothersome; 2 = moderate, definite itching that is somewhat bothersome; 3 = severe, intense itching that may interrupt daily activities and/or sleep|Week 3|||participants|||Number
658118|NCT01909713|Primary|Cutaneous Tolerability Based on Visual Inspection - Erythema|Cutaneous tolerability based on visual inspection (investigator reported severity scale) was assessed at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22). Erythema: 0 = none, no observable redness; 1 = very mild, slight redness, spotty or diffuse; 2 = mild, moderate redness; 3 = moderate, intense; 4 = severe, fiery red with edema.|Week 3|||participants|||Number
658119|NCT01909674|Primary|Comparison of the Effectiveness of Nasal Versus Oronasal CPAP Masks|Total Sleep Time (TST) The amount of actually sleep time in a sleep episode; this time is equal to the total sleep episode less the awake time. TST is the total of all REM and NREM sleep in a sleep episode.|3 weeks for each mask condition|higher values represent a better outcome||minutes||Standard Deviation|Mean
658120|NCT01909570|Other Pre-specified|Live Birth Delivery Rate|The delivery of a healthy child (o two)|38 weeks after embryo transfer|Women aged under 38 years, with BMI between 19-29 kg/m2, FSH <15mUI/mL on the third day and first cycle of IVF/ICSI or second cycle after a prior attempt with a positive pregnancy test result. The infertile period must be less of five years, without previous uterine surgery, uterine malformations, neither repeated spontaneous abortions.||percentage of live birth|||Number
658121|NCT01909570|Secondary|Multiple Pregnancy Rate|A multiple clinical pregnancy was defined by the presence of more tan one gestational sac with heartbeat on transvaginal ultrasonography at the 7th weeks of pregnancy|Seven weeks after embryo transfer|Women aged under 38 years, with BMI between 19-29 kg/m2, FSH <15mUI/mL on the third day and first cycle of IVF/ICSI or second cycle after a prior attempt with a positive pregnancy test result. The infertile period must be less of five years, without previous uterine surgery, uterine malformations, neither repeated spontaneous abortions.||percentage of multiple pregnancies|||Number
658122|NCT01909570|Primary|Clinical Pregnancy Rate|A clinical pregnancy was defined by the presence of a gestational sac with heartbeat on transvaginal ultrasonography at the 7th weeks of pregnancy|Seven weeks after embryo transfer|Women aged under 38 years, with BMI between 19-29 kg/m2, FSH <15mUI/mL on the third day and first cycle of IVF/ICSI or second cycle after a prior attempt with a positive pregnancy test result. The infertile period must be less of five years, without previous uterine surgery, uterine malformations, neither repeated spontaneous abortions.||percentage of pregnancy per transfer|||Number
658135|NCT01909466|Primary|Mean Change From Baseline Measured by EPS by Abnormal Involuntary Movement Scale (AIMS).|The AIMS assessment consisted of 10 items describing symptoms of dyskinesia. Facial and oral movements (items 1 through 4), extremity movements (items 5 and 6), and trunk movements (item 7) were observed unobtrusively while the participant was at rest (e.g., in the waiting room), and the study physician would make global judgments on the participant's dyskinesia's (items 8 through 10). These items are rated on a five-point scale of severity from 0–4. The scale is rated from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe). Overall AIMS scores range from 0 to 42.|Baseline to Week 20|The safety sample included all randomized participants who were administered at least one dose of study medication, regardless of any protocol violation. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.||Units on a scale||Standard Deviation|Mean
658123|NCT01909466|Secondary|Mean Change From Baseline in Social Integration Score of SWN-S.|The participant's feeling of their own well-being was assessed using the 20 question SWN-S. The SWN-S was a validated self-report instrument that evaluated the participant's perception of 1 being while receiving antipsychotic medication. The questionnaire consisted of 20 items and 5 subscales (mental functioning, social integration, emotional regulation, physical functioning, self-control) whose items followed in random order. For items marked with a '+', response choices and scoring were as follows: not at all = 1, hardly at all = 2, a little = 3, somewhat = 4, much = 5, very much = 6. For items marked with a '-', the scoring was reversed; response choices and scoring were as follows: not at all = 6, hardly at all = 5, a little = 4, somewhat = 3, much = 2, very much = 1. SWN-S subscale score's each item was rated on a score of 0 (none) to 6 (severe), with higher scores indicating stronger subjective feelings of deficit.|Baseline to Week 20|In efficacy analysis, the dataset included all randomized participants who received at least one dose of aripiprazole IM depot injection and had at least one efficacy assessment. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.||Units on a scale||Standard Deviation|Mean
658124|NCT01909466|Secondary|Mean Change From Baseline in Emotional Regulation Score of SWN-S.|The participant's feeling of their own well-being was assessed using the 20 question SWN-S. The SWN-S was a validated self-report instrument that evaluated the participant's perception of 1 being while receiving antipsychotic medication. The questionnaire consisted of 20 items and 5 subscales (mental functioning, social integration, emotional regulation, physical functioning, self-control) whose items followed in random order. For items marked with a '+', response choices and scoring were as follows: not at all = 1, hardly at all = 2, a little = 3, somewhat = 4, much = 5, very much = 6. For items marked with a '-', the scoring was reversed; response choices and scoring were as follows: not at all = 6, hardly at all = 5, a little = 4, somewhat = 3, much = 2, very much = 1. SWN-S subscale score's each item was rated on a score of 0 (none) to 6 (severe), with higher scores indicating stronger subjective feelings of deficit.|Baseline to Week 20|In efficacy analysis, the dataset included all randomized participants who received at least one dose of aripiprazole IM depot injection and had at least one efficacy assessment. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.||Units on a scale||Standard Deviation|Mean
658125|NCT01909466|Secondary|Mean Change From Baseline in Physical Functioning Score of SWN-S.|The participant's feeling of their own well-being was assessed using the 20 question SWN-S. The SWN-S was a validated self-report instrument that evaluated the participant's perception of 1 being while receiving antipsychotic medication. The questionnaire consisted of 20 items and 5 subscales (mental functioning, social integration, emotional regulation, physical functioning, self-control) whose items followed in random order. For items marked with a '+', response choices and scoring were as follows: not at all = 1, hardly at all = 2, a little = 3, somewhat = 4, much = 5, very much = 6. For items marked with a '-', the scoring was reversed; response choices and scoring were as follows: not at all = 6, hardly at all = 5, a little = 4, somewhat = 3, much = 2, very much = 1. SWN-S subscale score's each item was rated on a score of 0 (none) to 6 (severe), with higher scores indicating stronger subjective feelings of deficit.|Baseline to Week 20|In efficacy analysis, the dataset included all randomized participants who received at least one dose of aripiprazole IM depot injection and had at least one efficacy assessment. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.||Units on a scale||Standard Deviation|Mean
658126|NCT01909466|Secondary|Mean Change From Baseline in Self Control Score of SWN-S.|The participant's feeling of their own well-being was assessed using the 20 question SWN-S. The SWN-S was a validated self-report instrument that evaluated the participant's perception of 1 being while receiving antipsychotic medication. The questionnaire consisted of 20 items and 5 subscales (mental functioning, social integration, emotional regulation, physical functioning, self-control) whose items followed in random order. For items marked with a '+', response choices and scoring were as follows: not at all = 1, hardly at all = 2, a little = 3, somewhat = 4, much = 5, very much = 6. For items marked with a '-', the scoring was reversed; response choices and scoring were as follows: not at all = 6, hardly at all = 5, a little = 4, somewhat = 3, much = 2, very much = 1. SWN-S subscale score's each item was rated on a score of 0 (none) to 6 (severe), with higher scores indicating stronger subjective feelings of deficit.|Baseline to Week 20|In efficacy analysis, the dataset included all randomized participants who received at least one dose of aripiprazole IM depot injection and had at least one efficacy assessment. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.||Units on a scale||Standard Deviation|Mean
658127|NCT01909466|Secondary|Mean Change From Baseline in Mental Functioning Score of SWN-S.|The participant's feeling of their own well-being was assessed using the 20 question SWN-S. The SWN-S was a validated self-report instrument that evaluated the participant's perception of 1 being while receiving antipsychotic medication. The questionnaire consisted of 20 items and 5 subscales (mental functioning, social integration, emotional regulation, physical functioning, self-control) whose items followed in random order. For items marked with a '+', response choices and scoring were as follows: not at all = 1, hardly at all = 2, a little = 3, somewhat = 4, much = 5, very much = 6. For items marked with a '-', the scoring was reversed; response choices and scoring were as follows: not at all = 6, hardly at all = 5, a little = 4, somewhat = 3, much = 2, very much = 1. SWN-S subscale score's each item was rated on a score of 0 (none) to 6 (severe), with higher scores indicating stronger subjective feelings of deficit.|Baseline to Week 20|In efficacy analysis, the dataset included all randomized participants who received at least one dose of aripiprazole IM depot injection and had at least one efficacy assessment. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.||Units on a scale||Standard Deviation|Mean
658136|NCT01909466|Primary|Mean Change From Baseline Measured by Extrapyramidal Symptoms (EPS) by Simpson-Angus Scale (SAS).|The SAS consisted of a list of 10 symptoms of Parkinsonism (gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, head rotation, glabella tap, tremor, salivation, and akathisia). The SAS Total Score was the sum of the scores for all 10 items. SAS total score can range from 10 to 50. Each item was rated on a 5-point scale, with a score of 1 =absence of symptoms and a score of 5 =severe condition.|Baseline to Week 20|The safety sample included all randomized participants who were administered at least one dose of study medication, regardless of any protocol violation. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.||Units on a scale||Standard Deviation|Mean
658128|NCT01909466|Secondary|Mean Change From Baseline in Total Score of Subject Well-being Under Neuroleptic Treatment-Short Form (SWN-S).|The participant's feeling of their own well-being was assessed using the 20 question SWN-S. The SWN-S was a validated self-report instrument that evaluated the participant's perception of 1 being while receiving antipsychotic medication. The questionnaire consisted of 20 items and 5 subscales (mental functioning, social integration, emotional regulation, physical functioning, self-control) whose items followed in random order. For items marked with a '+', response choices and scoring were as follows: not at all = 1, hardly at all = 2, a little = 3, somewhat = 4, much = 5, very much = 6. For items marked with a '-', the scoring was reversed; response choices and scoring were as follows: not at all = 6, hardly at all = 5, a little = 4, somewhat = 3, much = 2, very much = 1. The total score from the scale ranges from 20 (bad subjective experience) to 120 (perfect subjective experience).|Baseline to Week 20+|In efficacy analysis, the dataset included all randomized participants who received at least one dose of aripiprazole IM depot injection and had at least one efficacy assessment. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.||Units on a scale||Standard Deviation|Mean
658129|NCT01909466|Secondary|Clinical Global Impression-Improvement (CGI-I) Score.|The efficacy of trial medication were rated for each participant using the CGI-I scale. The study physician must rate the participant's total improvement whether or not it is due entirely to drug treatment. All responses were compared to the participant's condition a baseline. Response choices include: 0 = not assessed; 1 =very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 =minimally worse; 6 = much worse; and 7 = very much worse.|Baseline to Week 20|In efficacy analysis, the dataset included all randomized participants who received at least one dose of aripiprazole IM depot injection and had at least one efficacy assessment. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.||Units on a scale||Standard Deviation|Mean
658130|NCT01909466|Secondary|Mean Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score.|"The severity of illness for each participant was rated using the CGI-S scale. To assess CGI-S, the study physician answered the following question: Considering your total clinical experience with this particular population, how mentally ill is the participant at this time? Response choices included: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants."|Baseline to Week 20|In efficacy analysis, the dataset included all randomized participants who received at least one dose of aripiprazole IM depot injection and had at least one efficacy assessment. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.||Units on a scale||Standard Deviation|Mean
658131|NCT01909466|Secondary|Mean Change From Baseline in PANSS Negative Sub-scale Score.|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS Negative Subscale ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms).|Baseline to Week 20|In efficacy analysis, the dataset included all randomized participants who received at least one dose of aripiprazole IM depot injection and had at least one efficacy assessment. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.||Units on a scale||Standard Deviation|Mean
658132|NCT01909466|Secondary|Mean Change From Baseline in PANSS Positive Sub-scale Score.|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS positive subscale score was the sum of the rating scores for the 7 positive scale items from the PANSS panel. The 7 positive symptom constructs are delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS Positive Subscale ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms).|Baseline to Week 20|In efficacy analysis, the dataset included all randomized participants who received at least one dose of aripiprazole IM depot injection and had at least one efficacy assessment. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.||Units on a scale||Standard Deviation|Mean
658133|NCT01909466|Secondary|Mean Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS).|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline to Week 20|In efficacy analysis, the dataset included all randomized participants who received at least one dose of aripiprazole IM depot injection and had at least one efficacy assessment. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.||Units on a scale||Standard Deviation|Mean
658134|NCT01909466|Primary|Mean Change From Baseline Measured by EPS by Barnes Akathisia Rating Scale (BARS).|The BARS consisted of 4 items related to akathisia: objective observation of akathisia by the study physician, subjective feelings of restlessness by the participant, participant distress due to akathisia, and global evaluation of akathisia. To complete this scale, participants were observed while they were seated and then stood for a minimum of 2 minutes in each position. Symptoms observed in other situations (e.g., while engaged in neutral conversation or engaged in activity on the ward) may also be rated. Subjective phenomena were to be elicited by direct questioning. The first 3 items were rated on a 4-point scale, with a score of 0 = absence of symptoms and a score of 3 = severe condition. The global clinical evaluation were made on a 6-point scale, (0=absent, 1=questionable, 2=mild, 3=moderate, 4=marked, 5=severe).|Baseline to Week 20|The safety sample included all randomized participants who were administered at least one dose of study medication, regardless of any protocol violation. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.||Units on a scale||Standard Deviation|Mean
658137|NCT01909466|Primary|Mean Change From Baseline in Suicidal Ideation Intensity Total Score Via Columbia-suicide Severity Rating Scale (C-SSRS).|Suicidality was monitored throughout the trial using C-SSRS. The C-SSRS addresses the need for standardized classification of suicide reports to assess suicide risk. This scale consisted of Baseline evaluation that assessed the lifetime experience of the participant with suicidal events and suicidal ideation and a post baseline evaluation that focuses on suicidality since the last trial visit. The C-SSRS since last visit form were completed on Day 1 pre-dose and prior to dosing on Days 29, 57, 85, 113, 141/ Early Termination(ET) and prior to pharmacokinetics(PK) sampling on Days 8, 15, 22, 120, 127 and 134. The suicidal ideation intensity total score was the sum of suicidal ideation severity rating scores for frequency, duration, controllability, deterrents, and reasons for ideation. For each item, each participant got an intensity score from 0(none) to 5(worst). Therefore,the suicidal ideation intensity total score range from 0 to 25, with a score of 0 given for no suicidal ideation.|Baseline to Last Visit (Day 141)|The safety sample included all randomized participants who were administered at least one dose of study medication, regardless of any protocol violation. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.||Units on a scale||Standard Deviation|Mean
658138|NCT01909466|Primary|Mean Visual Analog Scale (VAS) Score for Rating of Pain at the Injection Site.|Participants assessed the pain associated with injection of aripiprazole IM using the VAS instrument. This was done approximately 30 minutes pre-dose and 1 hour (±15 min) Post-dose on Days 1, 29, 57, 85 and 113. For the first injection, the pre-dose assessment was of the current injection site. For the injections 2 through 5, the pre-dose assessment was of the prior injection site. Investigator's Assessment of Most Recent Injection Site including pain, swelling, redness, and induration were reported in 4-point categorical scale (1 = absent, 2 = mild, 3 = moderate and 4 = severe) by first injection site at each injection.|Days 1 and 113|The safety sample included all randomized participants who were administered at least one dose of study medication, regardless of any protocol violation. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.||Units on a scale||Standard Deviation|Mean
658139|NCT01909466|Primary|Number of Participants With Adverse Events (AEs).|AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a participant while enrolled in the trial, whether or not it was considered drug related by the investigator. A serious adverse event (SAE) was any untoward medical occurrence that resulted in death or was life threatening or required inpatient hospitalization or prolonged hospitalization. A treatment-emergent AE (TEAE) was defined as an AE that started after start of study medication or an AE that continued from baseline and that worsened, was serious, was study medication related, or resulted in death, discontinuation, interruption, or reduction of study medication.|AEs were recorded from the time the informed consent was signed until follow-up for 28 days after last|The safety sample included all randomized participants who were administered at least one dose of study medication, regardless of any protocol violation.||participants|||Number
658140|NCT01909336|Secondary|Adverse Reactions Attributed to Acute Plasma Sodium Changes|Adjudicated Morbidity Attributed to Acute Plasma Sodium Changes assessed at 8 hours|8 hours|||Minor Adverse Reactions|||Number
658141|NCT01909336|Secondary|Dysnatraemias at T8|hyponatraemia (defined as serum sodium < 135 mmol/L), normonatremia (defined as serum sodium 135-145 mmol/L) or hypernatraemia (defined as serum sodium > 145 mmol/L)|8 hours|||participants|||Number
658142|NCT01909336|Primary|Hospital Acquired Hyponatremia|Serum sodium less than 135 mEq/L at 8 hours in a patient with normal serum sodium (135 mEq/L to 145mEq/L) at the beginning of the study|8 hours|||participants|||Number
658143|NCT01909180|Primary|Image Quality|"Image quality assessment on a 5 point Likert Scale:
5= Diagnostic- Excellent Image Quality 4= Diagnostic- Good Image Quality 3= Diagnostic-Acceptable Image Quality 2= Sub-Optimal Diagnostic with limited additional clinical information
1= Non-Diagnostic"|24 hours|All cases were sufficient and had acceptable, good or excellent image quality||units on a scale|Participants|Standard Deviation|Mean
658144|NCT01909141|Other Pre-specified|Safety of Pioglitazone as Regards Serum Creatinine|serum creatinine was measured at the end of the study period (after 3 months) in both groups.|3 months|||mg/dL||Standard Deviation|Mean
658145|NCT01909141|Secondary|Pregnancy Rate||3 months|||participants|||Number
658146|NCT01909141|Secondary|Endometrial Thickness||3 months|||mm||Standard Deviation|Mean
658147|NCT01909141|Secondary|Number of Follicles>18mm.||3 months|||follicles||Standard Deviation|Mean
658148|NCT01909141|Primary|Ovulation Rate||3 months|||percentage of all cycles|||Number
658149|NCT01909011|Primary|Change From Baseline in Mean Beck Depression Inventory (BDI) Score at Week 2|BDI is a validated, self-report measure used to assess the level of depression symptom severity. BDI values range from 0 (normal) to 63 (extreme depression). Mean Change = (Week 2 Mean Score - Baseline Mean Score).|Baseline to Week 2|Intent to treat population (all participants who received at least one dose of intervention). Last observation carried forward (LOCF) imputation method.||units on a scale||Standard Deviation|Mean
658150|NCT01909011|Secondary|Change From Baseline in Mean Clinical Global Impressions Illness Severity (CGI-S) Score at Week 2|CGI-S instrument measures the level of severity of illness rated by a qualified clinician. CGI-S values range from 1 (Normal, not at all ill) to 7 (Among the most extremely ill patients). Mean Change = (Week 2 Mean Score - Baseline Mean Score).|Baseline to Week 2|||units on a scale||Standard Deviation|Mean
658151|NCT01909011|Secondary|Change From Baseline in Mean Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Score at Week 2|Q-LES-Q is a validated 16-item self-report measure of the degree of enjoyment and satisfaction experienced by participants in various areas of daily functioning such as physical well-being, work, home, social relationships and leisure activities. Each item is rated on a 1 - 5 point scale. Q-LES-Q values range from 0 (very low quality of life) to 100 (high quality of life). Mean Change = (Week 2 Mean Score - Baseline Mean Score).|Baseline to Week 2|||units on a scale||Standard Deviation|Mean
658152|NCT01908842|Secondary|VAS Craving Scores: Stabilization/Maintenance|"Absolute mean ± standard deviation values for VAS cravings scores on Days 3, 4, 8, 15, and 22; the VAS craving scores range from 0 (no cravings) to 100 (most intense craving I have ever had)"|Days 3 through 22|Full analysis population - number of enrolled patients at the beginning of the measurement period||units on a scale||Standard Deviation|Mean
658999|NCT01890577|Secondary|Hemoglobin Excursions|Hemoglobin excursions defined as hemoglobin <10g/dL and >12g/dL. Due to the premature termination of the study no outcome measure data were analyzed.|Over the 15-month observation period||||||
658153|NCT01908842|Secondary|Visual Analog Scale (VAS) Cravings: Induction|"Absolute mean ± standard deviation values for VAS cravings at baseline, 0.5 h, 1.5 h, 3 h, and 6 post dose on Day 1, and Day 2; the VAS craving scores range from 0 (no cravings) to 100 (most intense craving I have ever had)"|Days 1 and 2|Full Analysis Population - number of enrolled patients at the beginning of the measurement period||units on a scale||Standard Deviation|Mean
658154|NCT01908842|Secondary|SOWS Total Scores: Stabilization/Maintenance|Absolute ± mean standard deviation values for SOWS total scores on Days 2, 3, 4, 8, 15, and 22; SOWS scores ranged from 0-64, with a lower score being more favorable|Days 3 through 22|Full Analysis Population - number of enrolled patients at the beginning of the measurement period||units on a scale||Standard Deviation|Mean
658155|NCT01908842|Primary|Primary Endpoints of Retention in Treatment at Days 3 and 15|Retention rates (number of patients retained) for the primary efficacy endpoints of retention in treatment at Days 3 and 15, which was defined as the number of patients who received treatment on Days 3 and 15.|Day 3 and Day 15|Per protocol population||participants|||Number
658156|NCT01908842|Secondary|Subjective Opiate Withdrawal Scale (SOWS) Scores: Induction|Absolute ± mean standard deviation values for SOWS total scores at baseline, 0.5 h, 1.5 h, 3 h, and 6 h post dose on Day 1, and Day 2; SOWS score ranges from 0-64, with a lower score being more favorable|Days 1 and 2|Full analysis population - number of enrolled patients at the beginning of the measurement period||units on a scale||Standard Deviation|Mean
658157|NCT01908842|Secondary|COWS Total Scores: Stabilization/Maintenance|Absolute ± mean standard deviation values for COWS total scores at Days 3, 4, 8, 15, and 22; COWS scores range from 0-48, with a lower score being more favorable|Days 3 through 22|Full analysis population - - number of enrolled patients at the beginning of the measurement period||units on a scale||Standard Deviation|Mean
658158|NCT01908842|Secondary|Clinical Opiate Withdrawal Scale (COWS) Scores: Induction|Absolute ± mean standard deviation values for COWS total scores at baseline; 0.5 h, 1.5 h, 3 h, and 6 h post dose on Day 1, and Day 2; COWS scores range from 0-48, with a lower score being more favorable|Days 1 and 2|Full Analysis Population - number of enrolled patients at the beginning of the measurement period||units on a scale||Standard Deviation|Mean
658228|NCT01907906|Secondary|Neoantigenicity - Day 21 Indirect Antigen Test (IAT)|Day 21 IAT testing of RBCs via LISS-15, Anti-IgG and C3 as derived from Mirasol-treated WB versus untreated WB. Number of positive results (indicating antibody formation to a new antigen) were recorded.|Day 21 of Treatment Periods 1 and 2|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test on Day 21 of both Treatment Periods 1 and 2||Positive results|||Number
658195|NCT01908803|Secondary|Median Time (in Days) to Cessation of Otorrhea|Median time (in days) to the cessation of otorrhea (ie, otorrhea was absent) was calculated as the number of days from the Day 1 (Visit 1) to the absence of otorrhea in the affected ear(s) as recorded by the parent/guardian via the twice-daily diary. Cessation of otorrhea was defined as ending on the first day that otorrhea was absent from the affected ear(s) and remained absent for any/all subsequent diary entries.|Time to event, up to Day 8|This analysis population includes all randomized subjects who received at least 1 dose of investigational product and were culture positive at the Day 1 visit in the study ear.||days||Standard Error|Median
658196|NCT01908803|Secondary|Proportion of Subjects With Microbiological Success at the Day 8 Visit|Microbiological success was attained if all pre-therapy bacteria were absent in the Day 8 specimen. In a subject with no otorrhea at Day 8, eradication of pre-therapy bacteria was presumed and the subject was considered a microbiological success.|Day 8|This analysis population includes all randomized subjects who received at least 1 dose of investigational product and were culture positive at the Day 1 visit in the study ear.||percentage of subjects||Standard Deviation|Mean
658197|NCT01908803|Primary|Proportion of Subjects With Sustained Clinical Cure at Day 3 Visit|A sustained clinical cure at Day 3 was attained if otorrhea was absent at the Day 3 visit and continued to be absent through the last study visit (Day 8 or Early Exit). Proportion of subjects is reported as a percentage.|Day 3 post-treatment up to Day 8 or Early Exit|This analysis population includes all randomized subjects who received at least 1 dose of investigational product and were culture positive at the Day 1 visit in the study ear.||percentage of subjects|||Number
658198|NCT01908140|Secondary|Transition Dyspnoea Index (TDI) Focal Score at Week 24|The TDI includes the same 3 categories as BDI and 7 ratings indicating the magnitude of the change from baseline in each category: from -3 (“major deterioration”) to zero (“no change”) to +3 (“major improvement”). Category scores are added to compute the Focal Score (from -9 to 9)|At Week 24|PP population defined as a subset of ITT constituted by patients who met all inclusion/exclusion criteria liable to affect the efficacy ssessment, attained sufficient compliance to treatment and did not present serious deviations of the protocol.||TDI Focal Score|Participants|Standard Error|Least Squares Mean
658199|NCT01908140|Primary|Peak Forced Expiratory Volume in One Second (FEV1) at Week 24|Peak FEV1 define at the highest value observed in the 3h after the morning IMP administration|At Week 24|"ITT population: randomized patients who took at least one dose of IMP and have a baseline FEV1 assessment.
PP population: subset of ITT constituted by patients who met all inclusion/exclusion criteria liable to affect the efficacy ssessment, attained sufficient compliance to treatment and did not present serious deviations of the protocol."||Liters|Participants|Standard Error|Least Squares Mean
658200|NCT01908127|Secondary|Index of Heart Rate|The heart rate of children was measured before the injection of local anesthesia solution to save a baseline data and it was also measured after the injection to assess the effect of this dental stress.|before and after the injection of local anesthesia solution|||beat per Min||Standard Deviation|Mean
658226|NCT01907906|Secondary|Neoantigenicity - Day 42 Indirect Antigen Test (IAT)|IAT testing of RBCs via low ionic strength solution (LISS-15), Anti-IgG and C3 as derived from Mirasol-treated WB versus untreated WB. Number of positive results (indicating antibody formation to a new antigen) were recorded.|Day 42 of Treatment Periods 1 and 2|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test on Day 42 of both Treatment Periods 1 and 2.||Positive results|||Number
658201|NCT01908127|Primary|Behaviors of Children|"A video-camera was focused started to record child’s behavior. The recorded video tapes were independently evaluated by 2 paediatric dentists who were blind to the grouping of the children. Children’s anxiety reactions and cooperative behaviours were scored based on venham scale and Frankle Index ,respectively. quantification was performed at the injection of local anaesthesia and at the beginning of the tooth preparation. An average of both two time points scoring was used.
Table 1: Venham 6-point Index 0 = Relaxed: 1 = Uneasy: 2 = Tense: 3 = Reluctant: 4 = Interference: 5 = Out of contact
Table 2: Frankle 4-point Index
1:Definitely Negative ( uncooperative,Refusal of treatment ) , 2:Negative ( some evidence of negative attitude but not pronounced) , 3:Positive ( Acceptance of treatment, at times cautious) , 4:Definitely Positive( Good rapport with the dentist)"|participants followed for the duration of examination and treatment appointment, an expected average of 3 weeks|||units on a scale||Standard Deviation|Mean
658202|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Hemolysis (%)||Day 21|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test||% of volume||Standard Deviation|Mean
658203|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Hemolysis (%)||Day 0|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test||% of volume||Standard Deviation|Mean
658204|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - 2,3-diphosphoglycerate (DPG)||Day 21|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test||µmol/mL||Standard Deviation|Mean
658205|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - 2,3-diphosphoglycerate (DPG)||Day 0|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test||µmol/mL||Standard Deviation|Mean
658206|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Supernatant Hgb||Day 21|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test||mg/dL||Standard Deviation|Mean
658207|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Supernatant Hgb||Day 0|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test||mg/dL||Standard Deviation|Mean
658208|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Lactate||Day 21|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test||mmol/L||Standard Deviation|Mean
658209|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Lactate||Day 0|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test||mmol/L||Standard Deviation|Mean
658210|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Glucose||Day 21|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test||mg/dL||Standard Deviation|Mean
658211|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Glucose||Day 0|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test||mg/dL||Standard Deviation|Mean
658212|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Potassium||Day 21|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test||mEq/L||Standard Deviation|Mean
658213|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Potassium||Day 0|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test||mEq/L||Standard Deviation|Mean
658214|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - pCO2 (mmHg at 37° C)||Day 21|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test||mmHg at 37° C||Standard Deviation|Mean
658215|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - pCO2 (mmHg at 37° C)||Day 0|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test||pCO2 (mmHg at 37° C)||Standard Deviation|Mean
658216|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - pH (at 37° C)||Day 21|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test||pH||Standard Deviation|Mean
658217|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - pH (at 37° C)||Day 0|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test||pH (at 37° C)||Standard Deviation|Mean
658218|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Total Hemoglobin||Day 21|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test||g/dL||Standard Deviation|Mean
658219|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Total Hemoglobin||Day 0|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test||g/dL||Standard Deviation|Mean
658220|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - White Blood Cell (WBC) Count||Day 21|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test||10E3 cells/µL||Standard Deviation|Mean
658221|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - White Blood Cell (WBC) Count||Day 0|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test||10E3 cells/µL||Standard Deviation|Mean
658222|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - ATP||Day 21|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test||µmol/g Hgb||Standard Deviation|Mean
658223|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - ATP||Day 0|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test||µmol/g Hgb||Standard Deviation|Mean
658224|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Hematocrit (%)||Day 21|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test||volume % of red blood cells||Standard Deviation|Mean
658225|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Hematocrit (%)||Day 0|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test||% of volume||Standard Deviation|Mean
658229|NCT01907906|Secondary|Neoantigenicity - Day 21 Direct Antigen Test (DAT)|DAT testing of Red Blood Cells (RBCs) via Anti-immunoglobulin G (Anti-IgG) and Anti Complement Component 3 (Anti-C3) as derived from Mirasol-treated whole blood (WB) versus untreated WB conducted on Day 21 of both Treatment Periods 1 and 2. Number of positive results (indicating a new antigen formation) were recorded.|Day 21|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test on Day 21 of both Treatment Periods 1 and 2||Positive results|||Number
658230|NCT01907906|Secondary|Spearman's Correlation Coefficients: Linear T50 (Days) With pCO2 (mmHg at 37° C)|Spearman's Correlation Coefficients comparing Linear T50 (Days) with pCO2 (mmHg at 37° C) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB|28 days|All subjects who signed an IC Form (were enrolled), met eligibility criteria, had no intercurrent illness or notable signs/symptoms during the 24 hours prior to reinfusion, had no evidence of neoantigen formation on stored LR-pRBCs, and had at least 4 blood samples collected within the first 22 min, 30 sec post-infusion in each treatment period.||Spearman's Correlation Coefficient|||Number
658231|NCT01907906|Secondary|Spearman's Correlation Coefficients: Linear T50 (Days) With Adenosine Triphosphate (ATP) (µmol/g Hgb)|Spearman's Correlation Coefficients comparing Linear T50 (Days) with ATP (µmol/g Hgb) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB|28 days|All subjects who signed an IC Form (were enrolled), met eligibility criteria, had no intercurrent illness or notable signs/symptoms during the 24 hours prior to reinfusion, had no evidence of neoantigen formation on stored LR-pRBCs, and had at least 4 blood samples collected within the first 22 min, 30 sec post-infusion in each treatment period.||Spearman's Correlation Coefficient|||Number
658232|NCT01907906|Secondary|Spearman's Correlation Coefficients: Linear T50 (Days) With Hemolysis (%)|Spearman's Correlation Coefficients comparing Linear T50 (Days) with each of Hemolysis (%) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB|28 days|All subjects who signed an IC Form (were enrolled), met eligibility criteria, had no intercurrent illness or notable signs/symptoms during the 24 hours prior to reinfusion, had no evidence of neoantigen formation on stored LR-pRBCs, and had at least 4 blood samples collected within the first 22 min, 30 sec post-infusion in each treatment period.||Spearman's Correlation Coefficient|||Number
658233|NCT01907906|Secondary|Spearman's Correlation Coefficients: 24-Hour RBC Recovery (%) pCO2 (mmHg at 37° C)|Spearman's Correlation Coefficients comparing 24-Hour RBC Recovery (%) with pCO2 (mmHg at 37° C) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB|24 hours|All subjects who signed an IC Form (were enrolled), met eligibility criteria, had no intercurrent illness or notable signs/symptoms during the 24 hours prior to reinfusion, had no evidence of neoantigen formation on stored LR-pRBCs, and had at least 4 blood samples collected within the first 22 min, 30 sec post-infusion in each treatment period.||Spearman's Correlation Coefficient|||Number
658234|NCT01907906|Secondary|Spearman's Correlation Coefficients: 24-Hour RBC Recovery (%) With Adenosine Triphosphate (ATP) (µmol/g Hgb)|Spearman's Correlation Coefficients comparing 24-Hour RBC Recovery (%) with ATP (µmol/g Hgb) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB|24 hours|All subjects who signed an IC Form (were enrolled), met eligibility criteria, had no intercurrent illness or notable signs/symptoms during the 24 hours prior to reinfusion, had no evidence of neoantigen formation on stored LR-pRBCs, and had at least 4 blood samples collected within the first 22 min, 30 sec post-infusion in each treatment period.||Spearman's Correlation Coefficient|||Number
658235|NCT01907906|Secondary|Spearman's Correlation Coefficients: 24-Hour Red Blood Cell (RBC) Recovery (%) With Hemolysis (%)|Spearman's Correlation Coefficients comparing 24-Hour RBC Recovery (%) with Hemolysis (%) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB|24 hours|All subjects who signed an IC Form (were enrolled), met eligibility criteria, had no intercurrent illness or notable signs/symptoms during the 24 hours prior to reinfusion, had no evidence of neoantigen formation on stored LR-pRBCs, and had at least 4 blood samples collected within the first 22 min, 30 sec post-infusion in each treatment period.||Spearman's Correlation Coefficient|||Number
658236|NCT01907906|Secondary|Area Under the Curve (AUC) of Red Blood Cell (RBC) Survival|Assessment of AUC of RBC survival over 28 days for RBCs derived from Mirasol-treated Whole Blood (WB) versus RBCs derived from untreated WB.|28 days|All subjects who signed an IC Form (were enrolled), met eligibility criteria, had no intercurrent illness or notable signs/symptoms during the 24 hours prior to reinfusion, had no evidence of neoantigen formation on stored LR-pRBCs, and had at least 4 blood samples collected within the first 22 min, 30 sec post-infusion in each treatment period.||Days * Percent Recovery||Standard Deviation|Mean
658237|NCT01907906|Secondary|Red Blood Cell (RBC) Survival by Product|Assessment of linear & exponential RBC survival and half-life (T50) over 28 days for RBCs derived from Mirasol-treated WB versus RBCs derived from untreated WB.|28 days|All subjects who signed informed consent,were eligible, had no intercurrent illness or notable signs/symptoms in 24 hrs prior to reinfusion, had no evidence of neoantigen formation on stored LR-pRBCs, and had ≥ 4 blood samples collected within the first 22 min 30 sec post-infusion in each treatment period.||Days||Standard Deviation|Mean
658238|NCT01907906|Primary|Red Blood Cell (RBC) 24-Hour Recovery|"To evaluate, as per FDA criteria, the 24-hour post transfusion RBC recovery in healthy adult subjects of leuko-reduced packed red blood cells (LR-pRBC) that have been derived from Mirasol-treated fresh WB units and stored at 1 to 6°C for 21 days.
24-hour RBC Recovery is a measure of the % of RBCs that are still functioning 24 hours after they have been reinfused back into the donor following storage over 21 days."|24 hours|All subjects who signed an IC form (were enrolled), met eligibility criteria, had no intercurrent illness or notable signs/symptoms during the 24 hours prior to reinfusion, had no evidence of neoantigen formation on stored LR-pRBCs, and had at least 4 blood samples collected during the first 22 min, 30 sec post-infusion in each treatment period.||% 24-hour RBC Recovery||Standard Deviation|Mean
658239|NCT01907854|Secondary|Number of Treatment Emergent Adverse Events (TEAEs)|A treatment emergent adverse event (TEAE) was defined as an event that had an onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. The number of TEAEs was recorded during 26 weeks of treatment plus one week follow-up period.|During 26 weeks of treatment plus one week follow-up period.|Safety analysis set-All randomised subjects receiving at least one dose of any of the trial product.||number of events|||Number
658241|NCT01907854|Secondary|Change in Systolic Blood Pressure and Diastolic Blood Pressure|Change from baseline in systolic and diastolic blood pressure were analysed after 26 weeks of treatment. Missing values were imputed using MMRM.|From baseline to week 26|FAS - All randomised subjects receiving at least one dose of any of the trial product||mmHg||Standard Deviation|Mean
658242|NCT01907854|Secondary|Change in Fasting Blood Lipids|Ratio to baseline in fasting blood lipids (total cholesterol, low density lipoprotein [LDL], very low density lipoprotein [VLDL], high density lipoprotein [HDL], triglycerides, and free fatty acids) were analysed after 26 weeks treatment. Missing values were imputed using MMRM. Here we are presenting ratio to baseline data.|From baseline to week 26|FAS-All randomised subjects receiving at least one dose of any of the trial product. There were missing baseline values for free fatty acids in 1 subject in the liraglutide arm and 6 subjects in the sitagliptin arm.||ratio||Standard Deviation|Mean
658243|NCT01907854|Secondary|Change in Fasting Plasma Glucose|Change from baseline in fasting plasma glucose was analysed after 26 weeks of treatment. Missing values were imputed using MMRM.|From baseline to week 26|FAS - All randomised subjects receiving at least one dose of any of the trial product.||nmol/L||Standard Deviation|Mean
658244|NCT01907854|Secondary|Change in Body Weight|Change from baseline in body weight was analysed after 26 weeks of treatment. Analysis population set: FAS: all randomised subjects receiving at least one dose of any of the trial products. Missing values were imputed using MMRM.|From baseline to week 26|FAS - All randomised subjects receiving at least one dose of any of the trial product.||kg||Standard Deviation|Mean
658245|NCT01907854|Primary|Change in HbA1c (Glycosylated Haemoglobin)|Change from baseline in HbA1c was analysed after 26 weeks of treatment. Analysis population set: full analysis set (FAS); all randomised subjects receiving at least one dose of any of the trial products. Missing values were imputed using mixed model for repeated measurements (MMRM).|From baseline to week 26|Full analysis set (FAS) -All randomised subjects receiving at least one dose of any of the trial product.||percentage of glycosylated haemoglobin||Standard Deviation|Mean
658246|NCT01907516|Secondary|Subject Satisfaction|Satisfaction was measured with a survey after completing using both reporting methods|6 weeks|||percentage of participants|||Number
658247|NCT01907516|Primary|Compliance With Home Blood Glucose Reporting|Compliance was calculated as a percentage for each method (Confidant or Voicemail) by dividing the total number of reported glucose readings among all participants by the total number of expected readings (4 daily) over the 6 week study time period. Women with gestational diabetes are instructed to monitor their glucose 4 times per day.|6 weeks|||percentage of expected glucose tests|||Number
658248|NCT01907490|Secondary|PK Parameters: AUC|Pharmacokinetics of Ha44 and Benzyl Alcohol evaluation|3 months||08/2017||||
658249|NCT01907490|Secondary|PK Parameters: Tmax|Pharmacokinetics of Ha44 and Benzyl Alcohol evaluation|3 months||08/2017||||
658250|NCT01907490|Secondary|Pk Parameters: Cmax|Pharmacokinetics of Ha44 and Benzyl Alcohol evaluation|3 months||08/2017||||
658251|NCT01907490|Primary|Number of the Subjects With AEs.|Safety and tolerability assessed by AEs. Number of subjects with reporting AEs.|3 months|paediatric population, children between ages 6 months to <18 years.||participants|||Number
658252|NCT01907334|Primary|Total Airway Resistance Increase|concentration of methacholine required to increase total airway resistance by 40% (PC40R5)|1 to 7 days|The analysis was performed on all 10 participants.||ln(mg/mL)||95% Confidence Interval|Geometric Mean
658253|NCT01907321|Secondary|Cough Expiratory Airflow|Cough airflow measure of peak expiratory flow rate|Change in baseline to 7 weeks|14 adults with a history of ischemic stroke in the previous 2 years. All but two participants (1 male, 1 female) completed the protocol.||Liters of air/second||Standard Deviation|Mean
658254|NCT01907321|Primary|Maximum Expiratory Pressure|This measure will indicate if there are strength gains in the respiratory muscle by measuring expiratory pressure generating ability.|Change in baseline to week 7|Data from 14 adults with a history of ischemic stroke was analyzed for changes in maximum expiratory pressure generating capacity, cough strength, and swallowing safety. All but 2 participants (1 male, 1 female) completed the protocol. Intent to treat analysis was used.||cm H2O (pressure measurement)||Standard Deviation|Mean
658255|NCT01907113|Secondary|Assessment of Tolerability by Investigator|Tolerability was assessed by the investigator based on adverse events and the laboratory evaluation.|Drug administration until end-of-study-examination, 5 days|Treated set||participants|||Number
658256|NCT01907113|Secondary|Safety: Physical Examination, Vital Signs, ECG and Laboratory Measurements|Number of participants with clinically relevant findings in physical examination, Vital Signs, Clinically Significant Abnormalities in Electrocardiogram (ECG) and Significant Changes from Baseline Laboratory Measurements|Drug administration until end-of-study-examination, 5 days|Treated set||participants|||Number
658257|NCT01907113|Secondary|Total Urinary Glucose Excretion (UGE)|Change from baseline in total urinary glucose excretion|24-0 h before drug administration and 0-4, 4-8, 8-12, 12-24, 24-36, 36-48, 48-72, 72-96 hours after drug administration (Interval 24-0 h before drug administration only for baseline UGE)|The UGE analysis set included all patients in the treated set who provided the baseline value from 0 to 24 hours before drug administration and the value for urinary glucose excretion from 0 to 24 hours after drug administration without important protocol violations relevant to the evaluation of Pharmacodynamics.||mg||Standard Error|Mean
658258|NCT01907113|Secondary|Plasma Protein Binding|"Plasma protein binding is the percent of analyte binding to the plasma protein, pre-dose plasma samples were spiked with Empa 1000 nmol/L.
The standard deviation is actually the coefficient of variation."|1 h before drug administration and 1:30 and 3:00 h after drug administration|PKS||percentage of plasma protein binding||Standard Deviation|Mean
658259|NCT01907113|Secondary|%AUCtz-∞ (Percentage of Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From the Time of the Last Quantifiable Data Point Extrapolated to Infinity)|Percentage of area under the concentration-time curve of the analyte in plasma over the time interval from the time of the last quantifiable data point extrapolated to infinity|1 h before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration|PKS||percent||Geometric Coefficient of Variation|Geometric Mean
658260|NCT01907113|Secondary|Renal Clearance of the Analyte in Plasma After Extravascular Administration|Renal Clearance of the Analyte in Plasma After Extravascular Administration for time interval 0-96 hours.|24-0 h before drug administration and 0-4, 4-8, 8-12, 12-24, 24-36, 36-48, 48-72, 72-96 hours after drug administration|PKS||mL/min||Geometric Coefficient of Variation|Geometric Mean
658261|NCT01907113|Secondary|fe0-96 (Fraction of Analyte Excreted Unchanged in Urine From Time Points 0 to 96 Hours)|Fraction of analyte excreted unchanged in urine from time point 0-96 hours.|24-0 h before drug administration and 0-4, 4-8, 8-12, 12-24, 24-36, 36-48, 48-72, 72-96 hours after drug administration|PKS||percentage of analyte||Geometric Coefficient of Variation|Geometric Mean
658262|NCT01907113|Secondary|Ae0-96 (Amount of Analyte That is Eliminated in Urine Over the Time Interval 0 to 96 h)|Amount of analyte that is eliminated in urine over the time interval 0-96 hours.|24-0 h before drug administration and 0-4, 4-8, 8-12, 12-24, 24-36, 36-48, 48-72, 72-96 hours after drug administration|PKS||nmol||Geometric Coefficient of Variation|Geometric Mean
658263|NCT01907113|Secondary|AUC0-tz (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point)|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point. The areas under the curve were calculated using the linear up/log down algorithm. If a drug concentration was equal to or higher than the preceding concentration, the linear trapezoidal method was used. If the drug concentration was smaller than the preceding concentration, the logarithmic method was used.|1 h before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration|PKS||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
658264|NCT01907113|Secondary|Apparent Volume of Distribution During the Terminal Phase Lz|Apparent volume of distribution during the terminal phase Lz|1 h before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration|PKS||L||Geometric Coefficient of Variation|Geometric Mean
658265|NCT01907113|Secondary|Apparent Clearance of the Analyte in the Plasma After Extravascular Administration|Apparent clearance of the analyte in the plasma after extravascular administration|1 h before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration|PKS||mL/min||Geometric Coefficient of Variation|Geometric Mean
658266|NCT01907113|Secondary|Terminal Rate Constant in Plasma|Terminal rate constant in plasma (Lz)|1 h before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration|PKS||1/h||Geometric Coefficient of Variation|Geometric Mean
658267|NCT01907113|Secondary|Half-life and Mean Residence Time of the Analyte in Plasma|Terminal half-life of Empagliflozin (t1/2) and Mean residence time of Empagliflozin in the body|1 h before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration|PKS||h||Geometric Coefficient of Variation|Geometric Mean
658268|NCT01907113|Secondary|Time to Maximum Concentration of the Analyte in Plasma|Time from last dosing to maximum concentration of Empagliflozin in plasma (tmax)|1 h before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration|PKS||h||Full Range|Median
658269|NCT01907113|Primary|Cmax (Maximum Concentration of the Analyte in Plasma)|Maximum concentration of Empagliflozin in plasma|1 hour (h) before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration|PKS||nmol/L||Geometric Coefficient of Variation|Geometric Mean
658270|NCT01907113|Primary|AUC0-∞ (Area Under the Concentration Time Curve of the Analyte in Plasma Over the Time Interval From 0 to Infinity)|Area under the concentration time curve of the analyte in plasma over the time interval from 0 to infinity. The areas under the curve were calculated using the linear up/log down algorithm. If a drug concentration was equal to or higher than the preceding concentration, the linear trapezoidal method was used. If the drug concentration was smaller than the preceding concentration, the logarithmic method was used.|1 hour (h) before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration|The PK analysis set (PKS) included all evaluable patients in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
658271|NCT01906658|Secondary|Proportion of Subjects With Treatment Emergent Suicidality||Baseline to Week 36|||Participants|||Count of Participants
658272|NCT01906658|Secondary|Proportion of Subjects With Adverse Events That Could Not be Controlled by Concomitant Medication||Baseline to Week 8|||Participants|||Count of Participants
658273|NCT01906658|Secondary|Proportion of Subjects With Adverse Events That Required Study Drug Discontinuation||Baseline to Week 8|||Participants|||Count of Participants
658274|NCT01906658|Primary|Proportion of Subjects With Adverse Events (AEs) That Required Study Drug Discontinuation or Could Not be Controlled With Concomitant Medication||Baseline to Week 8|||Participants|||Count of Participants
658275|NCT01906515|Primary|The Effect of SpHb on Transfusion Timeline|Length of time it takes to initiate a RBC transfusion after the need was first established.|During surgery (an average of about 4 hours)|We only included the participants who received a blood transfusion during the surgery for this analysis. Participants who did not receive a transfusion were excluded from this analysis.||minutes||95% Confidence Interval|Mean
658276|NCT01906515|Primary|RBC Transfusions Per Subject Receiving a Transfusion|Determine whether using SpHb can affect the quantity of RBC transfused, per patient receiving a transfusion.|During surgery (an average of about 4 hours)|We only included the participants who received a blood transfusion during the surgery for this analysis. Participants who did not receive a transfusion were excluded from this analysis.||units||95% Confidence Interval|Mean
658277|NCT01906515|Other Pre-specified|Potential Cost Savings|Potential cost saving resulting from reduced RBC utilization was estimated using activity-based cost estimates established by Shander et al.(8) which determined from both U.S. and European hospitals the total cost of transfusing one RBC unit to be between $522 and $1,183 with a mean and standard deviation of $761 ± $294.|During surgery (an average of about 4 hours)||||||
658335|NCT01904279|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR)|The ESR is an acute phase reactant and a measure of inflammation. A negative change from baseline indicates improvement.|Baseline, Week 4, 6, 9, 12, 18, 20, 27, 28, 36, 44, 45, 51, 52|Safety population. Number Analyzed represents participants evaluable for the specified category.||millimeters per hour (mm/h)||Standard Deviation|Mean
658278|NCT01906515|Secondary|SpHb Absolute and Trend Accuracy|To assess absolute accuracy, or single point comparison, paired SpHb and Hb measurements were compared pre- and post- transfusion and bias and standard deviation were calculated. A Bland Altman graph with limits of agreement (1.96 x standard deviation, adjusted for the bias) was plotted to show agreement across the range of values. To assess trending, a regression plot of changes in Hb and corresponding changes in SpHb was plotted and a coefficient of determination (R2) was calculated|During surgery (an average of about 4 hours)||||||
658279|NCT01906372|Secondary|Steroid-sparing Effect of H.P. Acthar Gel in Refractory Adult PM and DM Patients.|Mean change in glucocorticoid dose (equivalent prednisone dose) at 24 weeks compared to baseline.|Steroid sparing effect and safety and tolerability at 24 weeks compared to baseline|||mg||Standard Deviation|Mean
658280|NCT01906372|Primary|Specific Aim 1: Number of Subjects Meeting IMACS Preliminary Definition of Improvement (DOI).|3 of any of the 6 core set measures (CSM) improved by ≥ 20%, with no more than 2 CSM worsening by ≥25% (worsening measure cannot include the MMT). The DOI should be met at least once on any of the 6 follow up visits and maintained until week 24. Subjects not meeting DOI during the trial are treatment failures.|Primary end point: IMACS preliminary definition of improvement (DOI)|Total of 10 PM/DM patients completed the study.One additional patient dropped out of the study at 6 weeks due to worsening of conduction abnormalities (heart block unrelated to the study drug).The patient had not completed minimum 8 weeks of study drug required for outcome assessment as per study protocol, and was not included in primary analysis.||Participants|||Count of Participants
658281|NCT01905956|Secondary|Global Evaluation of Safety by the Subjects||12 weeks|The analysis is performed for all subjects of the Intention-to-treat population who answered the questions for the assessment. However, missing data still appeared.||subjects|||Number
658282|NCT01905956|Secondary|Global Evaluation of Safety by the Investigators||12 weeks|The analysis is performed for all subjects of the Intention-to-treat population who answered the questions for the assessment. However, missing data still appeared.||subjects|||Number
658283|NCT01905956|Secondary|Global Evaluation of Efficacy by the Subjects||12 weeks|The analysis is performed for all subjects of the Intention-to-treat population who answered the questions for the assessment. However, missing data still appeared.||subjects|||Number
658284|NCT01905956|Secondary|Global Evaluation of Efficacy by the Investigators||12 weeks|The analysis is performed for all subjects of the Intention-to-treat population who answered the questions for the assessment. However, missing data still appeared.||subjects|||Number
658285|NCT01905956|Secondary|Food Craving Questionnaire (FCQ)|"This validated questionnaire evaluates changes in food cravings. It contains 15 items and was completed by the subjects based on the momentary feeling at the study site during visits 2 to 5 (Baseline and week 4, 8 and 12). Assessment was based on the following 5-point Likert scale:
= I do not agree at all
= I do not agree
= Neutral
= I agree
= I highly agree
Results were expressed as the mean score for the whole population in the respective intervention group."|Baseline and 4, 8, and 12 weeks|The analysis is performed for all subjects of the Intention-to-treat population who answered the FCQ at all visits from v2 to v5. Missing data were appeared in 9 cases at visit v5 and additional in 8 cases at visit v4.||Units on a scale||Standard Deviation|Mean
658286|NCT01905956|Secondary|Mean Change in Body Fat Mass (kg) From Baseline to Week 12|"Body fat mass kg) was measured by bio-impedance method using validated electronic weighing scales (Tanita BC-420 SMA).
Results were reported as value at baseline minus value at week-12, ie. reduction of body fat mass kg) (positive values)."|Baseline and 12 weeks|Analysis of body fat was not performed for 1 subject (placebo) due to missing data from Visit 2 - Visit 5. At Visit 1, analysis was performed for 109 subjects only. As such, short of 1 baseline date.||kilogram (kg)||Standard Deviation|Mean
658287|NCT01905956|Secondary|Mean Change in Body Fat Content (%) From Baseline to Week 12|"Body fat content (%) was measured by bio-impedance method using validated electronic weighing scales (Tanita BC-420 SMA).
Results were reported as value at baseline minus value at week-12, ie. reduction of body fat content (%) (positive values)."|Baseline and 12 weeks|Analysis of body fat was not performed for 1 subject (placebo) due to missing data from Visit 2 - Visit 5. At Visit 1, analysis was performed for 109 subjects only. As such, short of 1 baseline date.||Percentage of body fat (%)||Standard Deviation|Mean
658288|NCT01905956|Secondary|Mean Change in Waist and Hip Circumference (cm) From Baseline to Week 12|"Waist circumference (cm) was measured at the level midway between the lateral lower rib margin and the iliac crest.
Hip circumference (cm) was measured as the maximal circumference over the buttocks.
Results were reported as value at baseline minus value at week-12, ie. amount of waist and hip circumference reduction (cm) (positive values)."|Baseline and 12 weeks|||centimetre (cm)||Standard Deviation|Mean
658289|NCT01905956|Primary|Mean Change in Body Weight From Baseline to Week 12|"Body weight (kg) was measured in subjects wearing underwear and no shoes using calibrated weighing scales (Tanita BC-420 SMA).
Results were reported as value at baseline minus value at week-12, ie. amount of weight loss in (kg) (positive values)."|Baseline and 12 weeks|||kilogram (kg)||Standard Deviation|Mean
658290|NCT01905657|Secondary|Duration of Response (DOR) by RECIST 1.1|DOR is measured from the time measurement criteria were first met for CR/PR (whichever was first recorded) until the first date that recurrent or progressive disease was objectively documented (taking as reference for progressive disease the smallest measurements recorded on study). DOR was censored at the last tumor assessment date if a responder did not have PD or death. Non-responders were not included in the analysis. DOR was analyzed using the Kaplan-Meier method and is reported in weeks.|Through database cutoff date of 30 Sep 2015 (Approximately 23 months)|The ITT population consisted of all participants who were randomized. Participants were included in the treatment group to which they were randomized.||Weeks||Full Range|Median
658291|NCT01905657|Secondary|Overall Response Rate (ORR) by RECIST 1.1|ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR; disappearance of all target lesions) or Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) based on blinded independent central radiologists' review using RECIST 1.1.|Through database cutoff date of 30 Sep 2015 (Approximately 23 months)|The ITT population consisted of all participants who were randomized and included in the efficacy analysis. Participants were included in the treatment group to which they were randomized.||Percentage of Participants||95% Confidence Interval|Number
659000|NCT01890577|Primary|Haemoglobin Concentration|Due to the premature termination of the study no outcome measure data were analyzed.|Each 4-week period for the duration of the study period (15 months)||||||
658292|NCT01905657|Primary|Percentage of Participants Discontinuing Study Drug Due to AEs|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily had to have a causal relationship with this treatment. An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of the study drug, was also an AE.|Up to approximately 23 months|The APAT population consisted of all participants who received at least one dose of study drug. Participants were included in the treatment group based on the study treatment they received.||Percentage of Participants|||Number
658293|NCT01905657|Primary|Percentage of Participants Experiencing Adverse Events (AEs)|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily had to have a causal relationship with this treatment. An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of the study drug, was also an AE. After discontinuation of study drug, each participant was monitored for a minimum of 30 days after last dose of study drug (serious AEs were monitored for up to 90 days after last dose of study drug).|AEs: Up to 30 days after last dose of study drug (Up to approximately 24 months). Serious AEs: Up to 90 days after last dose of study drug (Up to approximately 27 months).|The All Participants As Treated (APAT) population consisted of all participants who received at least one dose of study drug. Participants were included in the treatment group based on the study treatment they received.||Percentage of Participants|||Number
658294|NCT01905657|Primary|Progression-free Survival (PFS) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)|PFS was defined as the time from the first day of study treatment to the first documented disease progression per RECIST 1.1 based on blinded independent central radiologists’ review or death due to any cause, whichever occurred first. Using RECIST 1.1, progressive disease was defined as either a 20% relative increase in the sum of diameters of target lesions, taking as reference the smallest sum on study OR an absolute increase of >5 mm in the sum of lesions, OR the appearance of new lesions. PFS was analyzed using the Kaplan-Meier method and is reported in months.|Through database cutoff date of 30 Sep 2015 (Approximately 23 months)|The ITT population consisted of all participants who were randomized and included in the efficacy analysis. Participants were included in the treatment group to which they were randomized.||Months||95% Confidence Interval|Median
658295|NCT01905657|Primary|Overall Survival (OS)|OS was defined as the time from randomization to death due to any cause. OS was analyzed using the Kaplan-Meier method and is reported in months.|Through database cutoff date of 30 Sep 2015 (Approximately 23 months)|The Intent-To-Treat population consisted of all participants who were randomized and were included in the efficacy analysis. Participants were included in the treatment group to which they were randomized.||Months||95% Confidence Interval|Median
658296|NCT01905553|Primary|Maximum Plasma Concentration (Cmax) of SSP-004184 Under Fed and Fasted Conditions|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Over 96 hours post-dose|||ng/mL||Standard Deviation|Mean
658297|NCT01905553|Primary|Area Under the Concentration-time Curve From Time Zero to the Time of the Last Measureable Concentration (AUClast) of SSP-004184 Under Fed and Fasted Conditions|AUClast is the area under the curve from the time of dosing to the last measurable concentration. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Over 96 hours post-dose|Pharmacokinetic Set: All subjects in the Safety Set for whom the primary pharmacokinetic data were considered sufficient and interpretable.||ng*hr/mL||Standard Deviation|Mean
658298|NCT01905553|Primary|Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of SSP-004184 Under Fasted and Fed Conditions|AUCinf is the area under the plasma concentration versus time curve from time 0 to infinity. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Over 96 Hours post-dose|Pharmacokinetic Set: All subjects in the Safety Set for whom the primary pharmacokinetic data were considered sufficient and interpretable.||ng*hr/mL||Standard Deviation|Mean
658299|NCT01905540|Secondary|Maximum Plasma Concentration (Cmax) of SSP-004184 After Two Doses|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Over 120 hours post-dose|Pharmacokinetic Set: All subjects who had taken at least 1 dose of investigational product, had at least 1 post-dose safety assessment, and for whom the primary pharmacokinetic data were considered sufficient and interpretable.||ng/mL||Standard Deviation|Mean
658300|NCT01905540|Secondary|Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of SSP-004184 After Two Doses|AUCinf is the area under the plasma concentration versus time curve extrapolated to infinity, calculated using the observed value of the last nonzero concentration. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Over 120 hours post-dose|Pharmacokinetic Set: All subjects who had taken at least 1 dose of investigational product, had at least 1 post-dose safety assessment, and for whom the primary pharmacokinetic data were considered sufficient and interpretable.||ng*hr/mL||Standard Deviation|Mean
658301|NCT01905540|Secondary|Area Under the Steady-state Plasma Concentration-time Curve (AUClast) of SSP-004184 After Two Doses|AUClast is the area under the concentration versus time curve from the time of dosing to the last measurable concentration. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Over 120 hours post-dose|Pharmacokinetic Set: All subjects who had taken at least 1 dose of investigational product and had at least 1 post-dose safety assessment and for whom the primary pharmacokinetic data were considered sufficient and interpretable.||ng*hr/mL||Standard Deviation|Mean
660800|NCT01852955|Secondary|Postoperative Opioid Consumption|Postoperative opioid consumption over 24 hours. Converted into oral mg of morpine equivalents.|24 hour|||oral mg of morpine equivalents||Inter-Quartile Range|Median
658302|NCT01905540|Primary|Maximum Plasma Concentration (Cmax) of SSP-004184 After One Dose|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated|Over 120 hours post-dose|Pharmacokinetic Set: All subjects who had taken at least 1 dose of investigational product, had at least 1 post-dose safety assessment, and for whom the primary pharmacokinetic data were considered sufficient and interpretable.||ng/mL||Standard Deviation|Mean
658303|NCT01905540|Primary|Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of SSP-004184 After One Dose|AUCinf is the area under the curve extrapolated to infinity, calculated using the observed value of the last nonzero concentration. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Over 120 hours post-dose|Pharmacokinetic Set: All subjects who had taken at least 1 dose of investigational product, had at least 1 post-dose safety assessment, and for whom the primary pharmacokinetic data were considered sufficient and interpretable.||ng*h/mL||Standard Deviation|Mean
658304|NCT01905540|Primary|Area Under the Steady-state Plasma Concentration-time Curve (AUClast) of SSP-004184 After One Dose|AUC 0-last is the area under the plasma concentration versus time curve from time 0 to the time of last quantifiable concentration. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body|Over 120 hours post-dose|Pharmacokinetic Set: All subjects who had taken at least 1 dose of investigational product, had at least 1 post-dose safety assessment, and for whom the primary pharmacokinetic data were considered sufficient and interpretable.||ng*h/mL||Standard Deviation|Mean
658305|NCT01905254|Primary|Sensitivity and Specifity of Transient Elastography in Detection of Liver Cirrhosis|The aim of the current study was to assess the diagnostic accuracy (Sens., Spec.) of transient elastography for the determination of cirrhosis in patients with autoimmune hepatitis. TE was compared to the diagnosis of cirrhosis made on histology yielded by laparoscopic guided liver biopsy.|Transient Elastography compared to liver histology|Sensitivity, specifity; Positive and negative predictive value of TE for diagnosis of cirrhosis was analyzed.||Probability|||Number
658306|NCT01904864|Primary|Hemoglobin Concentration Over Time|The primary outcome will be the change in the peripheral blood hemoglobin concentration in grams/deciliter upon serial measurements at 0, 4, 8, and 12 weeks post-initiation of treatment.|12 weeks|||g/dL||Standard Deviation|Mean
658307|NCT01904773|Primary|Pharmacokinetics : AUC (h*ng/ ml) - Part 1 Only|Pharmacokinetics Part 1 only: Single dose Day 1 AZD5213 0.5 mg Area Under the Concentration time curve (AUC) 0 to infinity (h*ng/ml)|Day 1|Pharmacokinetic population||AUC (h*ng/ml)||Standard Deviation|Mean
658308|NCT01904773|Primary|Pharmacokinetics : Time to Maximum Concentration (hr) - Part 1 Only|Pharmacokinetics Part 1 only: Time to maximum plasma concentration (hr)Single dose Day 1 AZD5213 0.5 mg|Day 1|Pharmacokinetic population||Time (hr)||Standard Deviation|Mean
658309|NCT01904773|Primary|Pharmacokinetics : Maximum Plasma Concentration (ng/ml) - Part 1 Only|Pharmacokinetics Part 1 only: Maximum plasma Concentration (ng/ml) Single dose Day 1 AZD5213 0.5 mg|Day 1|Pharmacokinetic population||Plasma concentration (ng/ml)||Standard Deviation|Mean
658310|NCT01904773|Primary|Total Tic Severity Score (Part 2 Only) Crossover Analysis Over 6 Periods|Total Tic Severity Score on the the Yale Global Tic Severity Scale - Part 2 only (lower is better), range 0 - 50|3 week period of treatment|All Part 2 participants||Total Tic Severity Score||Standard Error|Least Squares Mean
658311|NCT01904760|Other Pre-specified|Pain Score Within 5 Days Postoperatively|Participants are followed for 5 days after operation and their pain score are evaluated by VAS method every afternoon on each of the 5 days. Patients' pain score on maxillofacial region and flap donation region are evaluated respectively.|on each of the 5 days postoperatively||||||
658312|NCT01904760|Other Pre-specified|Sleep Quality Within 5 Days Postoperatively|Participants are followed for 5 days after operation and their sleep quality are evaluated every afternoon on each of the 5 days.|on each of the 5 days postoperatively||||||
658313|NCT01904760|Other Pre-specified|Overall Feeling in PACU|Patients' overall feeling in PACU are evaluated by a numerous scale(0-10) at 8am the next day.|at 8am the next day||||||
658314|NCT01904760|Other Pre-specified|Sleep Quality in PACU|Patients' sleep quality in PACU are evaluated by a numerous scale(0-10) at 8am the next day.|at 8am the next day||||||
658315|NCT01904760|Other Pre-specified|Pain Score in PACU|Patients' pain score are evaluated by a numerous scale(0-10) at 8am the next day, just before they leave PACU.|at 8 am the next day||||||
658316|NCT01904760|Other Pre-specified|Use of Analgesics and Sedatives in PACU|extra analgesics and sedatives will be given when patients are agitated or if the patients ask for them.|participants will be followed for the duration of PACU stay, an expected average of 12 hours||||||
658317|NCT01904760|Other Pre-specified|Patients' Vital Signs in PACU|Patient's vital signs including heart rate, blood pressure, pulse oxygen saturation and respiratory rate are monitored continuously in PACU and recorded on 1,2,4,6,12 hour after PACU admission.|participants will be followed for the duration of PACU stay, an expected average of 12 hours||||||
658318|NCT01904760|Secondary|Postoperative Delirium|Patients are sent back to wards the next morning after operation and followed up on each of the 5 days postoperatively. Delirium will be confirmed based on CAM-ICU method.|on each of the 5 days postoperatively|||participants|||Number
658319|NCT01904760|Primary|Agitation in PACU|Patients are kept calm and cooperative in the PACU. Agitation is defined as Riker-Agitation Scale(SAS)>=5.|participants will be followed for the duration of PACU stay, an expected average of 12 hours|||participants|||Number
658320|NCT01904721|Secondary|Change From Baseline in Target Area Hair Darkness (TAHD)|Digital imaging analysis was used to measure TAHD. The darkness of all terminal hairs (individual hairs ≥ 30 microns in width) in the target area were summed and divided by total number of terminal hairs in the same target area and was reported as intensity units. A positive change from Baseline indicated improvement (increase in the darkness of terminal hairs) and a negative change from Baseline indicated worsening (decrease in the darkness of terminal hairs).|Baseline, Month 6|Modified Intent-to-Treat: all randomized patients in Stage 2 who received study medication and who had both baseline and follow-up TAHC measurements||Intensity Units||Standard Deviation|Mean
658336|NCT01904279|Secondary|Change From Baseline in C-Reactive Protein (CRP) Levels||Baseline, Weeks 4, 6, 9, 12,18, 20, 27, 28, 36, 44, 45, 51, 52|Safety population. Number Analyzed represents participants evaluable for the specified category.||mg/L||Standard Deviation|Mean
658321|NCT01904721|Secondary|Change From Baseline in Target Area Hair Width (TAHW)|Digital imaging analysis was used to measure TAHW in millimeters/centimeters squared (mm/cm^2). The diameters of all terminal hairs (individual hairs ≥ 30 microns in width) in the target area were summed and reported together. A positive change from Baseline indicated improvement (increase in the diameter of terminal hairs) and a negative change from Baseline indicated worsening (decrease in the diameter of terminal hairs).|Baseline, Month 6|Modified Intent-to-Treat: all randomized patients in Stage 2 who received study medication and who had both baseline and follow-up TAHC measurements||mm/cm2||Standard Deviation|Mean
658322|NCT01904721|Secondary|Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score|"At the completion of the study, 3 independent dermatologists using the 7-point GPR score compared photographs of the participant's scalp hair growth at Month 6 to Baseline and answered the question: Compared with the baseline image, the amount of the subject’s hair has?: Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented."|Month 6|Modified Intent-to-Treat: all randomized patients in Stage 2 who received study medication and who had both baseline and follow-up TAHC measurements||Percentage of Participants|||Number
658323|NCT01904721|Secondary|Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score|"The investigator compared the participant's scalp hair growth at Month 6 to a photograph of the scalp taken at Baseline and using the 7-point IGA score, the investigator answered the question: Since the start of the study, the amount of the subject’s hair has?: Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented."|Month 6|Modified Intent-to-Treat: all randomized patients in Stage 2 who received study medication and who had both baseline and follow-up TAHC measurements||Percentage of Participants|||Number
658324|NCT01904721|Primary|Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score|"The SSA score measured scalp hair growth. Using a 7-point scale, participants answered the Question: Since the start of the study, the amount of my hair has?: Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented."|Month 6|Modified Intent-to-Treat: all randomized patients in Stage 2 who received study medication and who had both baseline and follow-up TAHC measurements||Percentage of Participants|||Number
658325|NCT01904721|Primary|Change From Baseline in Target Area Hair Count (TAHC)|TAHC was measured using digital imaging analysis and was reported in terminal hairs/centimeters squared (cm^2). A positive change from Baseline indicated improvement (increase in the number of terminal hairs) and a negative change from Baseline indicated worsening (decrease in the number of terminal hairs).|Baseline, Month 6|Modified Intent-to-Treat: all randomized patients in Stage 2 who received study medication and who had both baseline and follow-up TAHC measurements||terminal hairs/cm2||Standard Deviation|Mean
658326|NCT01904604|Secondary|Percentage of Subjects Who Successfully Complete the Dosing Regimen With no More Than Mild Symptoms Related to Peanut Patch Dosing After 30 Months of Therapy|Mild symptoms related to peanut patch dosing are defined as patch site reactions up to Grade 2 in severity or mild systemic dosing symptoms.|Month 30 (Week 130)||12/2019||||
658327|NCT01904604|Secondary|Percentage of Subjects With Adverse Events Related to Therapy Through Week 52 and Through 30 Months|Adverse events (AEs) related to study therapy includes both unsolicited AEs where there was a reasonable possibility that the study product caused the event as well as solicited AEs related to dosing.|Week 52 and Month 30 (Week 130)|All randomized subjects who received study treatment.||percentage of participants|||Number
658328|NCT01904604|Secondary|Percentage of Subjects Who Pass an OFC to 5044 mg of Peanut Protein Followed by an Open Feeding of Peanut Butter After 8 Weeks or 20 Weeks of Discontinuation of Dosing Subsequent to Passing the Week 130 Oral Food Challenge (OFC)|Subjects who after passing the Week 130 (Month 30) discontinue dosing for 8 weeks and later 20 weeks successfully consumed 5044 mg peanut protein during an OFC followed by an open feeding of peanut butter.|8 and 20 weeks after the Week 130 (Month 30) OFC||12/2019||||
658329|NCT01904604|Secondary|Average Successfully Consumed Dose as Measured by 5044 mg Peanut Protein Oral Food Challenge (OFC)|The successfully consumed dose (SCD) is the cumulative dose consumed during an oral food challenge without dose-limiting symptoms that led to the termination of the challenge.|Week 52|All randomized subjects who completed the Week 52 OFC.||mg protein||Full Range|Median
658330|NCT01904604|Secondary|Percentage of Desensitized Subjects in the Active Treatment Arms as Measured by 5044 mg Peanut Protein Oral Food Challenge (OFC)|"Desensitization is defined based on successfully consumed dose in mg protein at the Week 52 oral food challenge (OFC) as follows:
0-44 mg at BL, >=444 mg at Wk52 2) >44-<444 mg at BL, 10-fold increase at Wk 52 3) >=444 mg at BL, >=5,044 mg at Wk 52.
BL=Baseline, Wk 52=Week 52"|Week 52|All randomized subjects who received active (not placebo) study treatment.||percentage of participants|||Number
658331|NCT01904604|Secondary|Percentage of Subjects Who Can Successfully Consume 1044 mg or 5044 mg Peanut Protein|Subjects who successfully consumed without dose-limiting symptoms 1044 mg or 5044 mg peanut protein during the Week 130 oral food challenge (OFC).|Week 130 (Month 30)||12/2019||||
658332|NCT01904604|Secondary|Percentage of Subjects Desensitized to Peanut Protein|"Desensitization is defined based on successfully consumed dose in mg protein at the Week 130 oral food challenge (OFC) as follows:
1) 0-44 mg at BL, >=444 mg at Wk 130 2) >44-<444 mg at BL, 10-fold increase at Wk 130 3) >=444 mg at BL, >=5,044 mg at Wk 130.
BL=Baseline, Wk 130=Week 130 (Month 30)"|Week 130 (Month 30)||12/2019||||
658333|NCT01904604|Primary|Percentage of Subjects With a Successful Treatment Response|Treatment response is defined as a subject who can either (a) successfully consume a cumulative dose of peanut protein equal to or greater than 5044 mg or (b) successfully consume at least a 10-fold increase in peanut protein at the Week 52 oral food challenge (OFC), when compared to the cumulative successfully consumed dose at the baseline OFC.|Week 52|All randomized subjects who received study treatment.||percentage of participants|||Number
658334|NCT01904279|Secondary|Percentage of Participants With Anti-TCZ Antibodies of Neutralizing Potential||Baseline up to Week 52|Safety population.||percentage of participants|||Number
658350|NCT01904071|Primary|Pain Score at 30 Minutes|Pain Score at 30 minutes post-administration of pain control treatment. Pain Scale: Scores range from 0 (no pain) to 10 (sever pain). A score of 5 is moderate pain|30 minutes|||units on a scale||Standard Deviation|Mean
658337|NCT01904279|Secondary|Change From Baseline in Soluble IL-6 Receptor Levels||Baseline, Days 0.25, 0.5, 2, 4, 5, 84.25, 84.5, 85, 86, 88, 90; Weeks 2, 3, 4, 6, 12, 14, 15, 27, 28, 36, 44, 52|Safety population. Here Number of participants analyzed represents participants evaluable for this outcome measure. Number Analyzed represents participants evaluable for the specified category.||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
658338|NCT01904279|Secondary|Change From Baseline in Serum Interleukin-6 (IL-6) Levels|IL-6 is a cytokine associated with disease activity in juvenile idiopathic arthritis (JIA) including the polyarticular juvenile idiopathic arthritis (pJIA) subset. It is found in high levels in the synovial fluid and is associated with indicators of inflammatory activity.|Baseline, Days 0.25, 0.5, 2, 4, 5, 84.25, 84.5, 85, 86, 88, 90; Weeks 2, 3, 4, 6, 12, 14, 15, 27, 28, 36, 44, 52|Safety population. Here Number of participants analyzed represents participants evaluable for this outcome measure. Number Analyzed represents participants evaluable for the specified category.||picograms/milliliter (pg/mL)||Standard Deviation|Mean
658339|NCT01904279|Primary|Maximum Serum Concentration (Cmax) of TCZ at Steady State|Detailed timeframe for TCZ SC 162 mg Q3W arm: pre-dose (Hour 0), 96, 504, 1008, 2016, 2022, 2064, 2112, ,2160, 2520 hours post Day 1 dose (additionally at 6, 12, 48, 120, 2028 hours post Day 1 dose in participants >/=2 years old). Detailed timeframe for TCZ SC 162 mg Q2W arm: pre-dose (Hour 0), 6, 12, 48, 120, 336, 672, 1008, 2016, 2022, 2028, 2040, 2064, 2112, 2160, 2520 hours post Day 1 dose.|Pre-dose (Hour 0) up to 2520 hours post Day 1 dose (detailed timeframe is provided in outcome description section)|Pharmacokinetic population||mcg/mL||Full Range|Median
658340|NCT01904279|Primary|Area Under the Curve at Steady-state Over a 12-week Interval (AUC12weeks) of TCZ Treatment|Detailed timeframe for TCZ SC 162 mg Q3W arm: pre-dose (Hour 0), 96, 504, 1008, 2016 hours post Day 1 dose (additionally at 6, 12, 48, 120 hours post Day 1 dose in participants >/=2 years old). Detailed timeframe for TCZ SC 162 mg Q2W arm: pre-dose (Hour 0), 6, 12, 48, 120, 336, 672, 1008, 2016 post Day 1 dose.|Pre-dose (Hour 0) up to 2016 hours post Day 1 dose (detailed timeframe is provided in outcome description section)|Pharmacokinetic population.||mcg*day/mL||Full Range|Mean
658341|NCT01904279|Primary|Minimum Serum Concentration (Cmin) of TCZ at Steady State|Detailed timeframe for TCZ SC 162 mg Q3W arm: pre-dose (Hour 0), 96, 504, 1008, 2016, 2022, 2064, 2112, 2160, 2520 hours post Day 1 dose (additionally at 6, 12, 48, 120, 2028 hours post Day 1 dose in participants >/=2 years old). Detailed timeframe for TCZ SC 162 mg Q2W arm: pre-dose (Hour 0), 6, 12, 48, 120, 336, 672, 1008, 2016, 2022, 2028, 2040, 2064, 2112, 2160, 2520 hours post Day 1 dose.|Pre-dose (Hour 0) up to 2520 hours post Day 1 dose (detailed timeframe is provided in outcome description section)|Pharmacokinetic population included all enrolled participants who were adherent to the protocol.||Micrograms/milliliter (mcg/mL)||Full Range|Median
658342|NCT01904149|Secondary|Percentage of Responders According to PI-VAS (Pain Intensity – Visual Analogue Scale)|"Percentage of responders; response defined as achievement a mean pain intensity, PI-VAS < 40 mm (PI-VAS corresponds to the pain intensity measured by a 0-100 visual analogue scale, 0=no pain to 100=worst pain imaginable), over 48 hours of the multiple-dose phase.
The analysis was performed combining all randomization arms including the same active treatment, which resulted in the following 3 analysis groups: DKP/TRAM, DEXKETOPROFEN, and TRAMADOL."|over 48 hours of the multiple-dose phase|ITT population||percentage of participants|||Number
658343|NCT01904149|Secondary|SPID48 (Sum of Pain Intensity Differences Over 48 Hours of the Multiple-dose Phase)|"Sum of Pain Intensity Differences calculated as the weighted sum of the PI-VAS differences over 48 hours of the multiple-dose phase.
PI-VAS corresponds to the pain intensity measured by a 0-100 visual analogue scale (0=no pain to 100=worst pain imaginable) which was measured every two hours over the first 48 hours of the multiple-dose phase. A higher value in SPID indicates greater pain relief.
The analysis was performed combining all randomization arms including the same active treatment, which resulted in the following 3 analysis groups: DKP/TRAM, DEXKETOPROFEN, and TRAMADOL."|over 48 hours of the multiple-dose phase|ITT population||units on a scale||Standard Deviation|Mean
658344|NCT01904149|Secondary|Percentage of Responders According to 50% Max TOTPAR (Total Pain Relief)|"Percentage of responders over 8 hours after first dose, according to the 50% maximum total pain relief rule: maximum TOTPAR calculated as the theoretical maximum weighted sum of PAR-VRS (Pain Relief – Verbal Rating Scale: pain relief 0=none, 4=complete) scores.
The analysis was performed combining all randomization arms including placebo into one group, which resulted in the following 4 analysis groups: DKP/TRAM, DEXKETOPROFEN, TRAMADOL, and Placebo."|over 8 hours after first dose|ITT population||percentage of participants|||Number
658345|NCT01904149|Primary|SPID8 (Sum of Pain Intensity Differences Over 8 Hours)|"Sum of Pain Intensity Differences calculated as the weighted sum of the PI-VAS differences over 8 hour period. PI-VAS corresponds to the pain intensity measured by a 0-100 visual analogue scale (0=no pain to 100=worst pain imaginable) which was measured at 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, and 8h after the first dose. A higher value in SPID indicates greater pain relief.
The analysis was performed combining all randomization arms including placebo into one group, which resulted in the following 4 analysis groups: DKP/TRAM, DEXKETOPROFEN, TRAMADOL, and Placebo."|over 8 hours after the first dose|ITT population||units on a scale||Standard Deviation|Mean
658346|NCT01904071|Other Pre-specified|Pain Score at 480 Minutes|Pain score at 480 minutes post administration of pain control treatment. Pain Scale: Scores range from 0 (no pain) to 10 (sever pain). A score of 5 is moderate pain|480 minutes|Pain scores were not obtained for 4 patients in the UFNB group, 3 patients in the UFIB group, and 3 patients in the IVMS group at 480 minutes||units on a scale||Standard Deviation|Mean
658347|NCT01904071|Other Pre-specified|Pain Score at 240 Minutes|Pain Score at 240 minutes post administration of pain control treatment. Pain Scale: Scores range from 0 (no pain) to 10 (sever pain). A score of 5 is moderate pain|240 minutes|Pain score was not obtained for one patient in the UFNB group at 240 minutes||units on a scale||Standard Deviation|Mean
658348|NCT01904071|Other Pre-specified|Pain Score at 120 Minutes|Pain score at 120 minutes post-administration of pain control treatment. Pain Scale: Scores range from 0 (no pain) to 10 (sever pain). A score of 5 is moderate pain|120 minutes|Pain score was not obtained for one patient in the IVMS group at 120 minutes.||units on a scale||Standard Deviation|Mean
658349|NCT01904071|Secondary|Pain Score at 60 Minutes|Pain score at 60 minutes post-administration of pain control treatment. Pain Scale: Scores range from 0 (no pain) to 10 (sever pain). A score of 5 is moderate pain|60 minutes|||units on a scale||Standard Deviation|Mean
658372|NCT01903863|Secondary|Plasma Free Hemoglobin|Compare plasma free hemoglobin levels between control and treatment group|ECMO course (median 198 hours)|||mg/dL||Inter-Quartile Range|Median
658351|NCT01904058|Other Pre-specified|Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product, whether or not considered related to the product. A serious adverse event (SAE) was defined as an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening; persistent or significant disability/incapacity; congenital anomaly or birth defect; an important medical event that did not meet any of the above criteria but jeopardized the participant or required medical or surgical intervention to prevent one of the outcomes listed above. A TEAE was defined as any AE that occurred during the study, from the start of investigational product dosing through the end of the study (13 weeks of treatment period (or ET) + 14 days ]), or that worsened since the start of dosing.|From the first dose of study drug until the 13 weeks of treatment period (or ET) + 14 days (approximately 15 weeks)|The Safety Population included all participants who were randomized and received at least 1 dose of the study drug. One participant was randomized to LUM001 10 mg, but was down-titrated to 5 mg dose due to tolerability issues. The safety data has been summarized based on the study dose actually received by the participant.||participants|||Number
658352|NCT01904058|Secondary|Change From Baseline in Bile Acid Synthesis as Measured by Serum 7 Alpha-Hydroxy-4-Cholesten-3-One C4 Level [7 Alpha C4]) at Weeks 4, 8, 13, and Last Post -Baseline Visit (Week 13/ET)|C4 7 alpha-hydroxy-4-cholesten-3-one is an intermediate in the biochemical synthesis of bile acids from cholesterol and its concentrations reflect the activity of the bile acid synthetic pathway. Elevated levels of C4 indicate bile acid malabsorption. Laboratory C4 levels were evaluated using blood samples collected.|Baseline, Weeks 4, 8, 13 and Last Post-baseline Visit (Week 13/ET)|mITT Population. Here, “n” signifies the number of participants evaluable for the respective time points.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
658353|NCT01904058|Secondary|Change From Baseline in Fasting Serum Bile Acid Level at Weeks 4, 8, 13, and Last Post -Baseline Visit (Week 13/ET)|Laboratory serum bile acid level levels were evaluated using blood samples collected.|Baseline, Weeks 4, 8, 13 and Last Post-baseline visit (Week 13/ET)|mITT Population. Here, “n” signifies the number of participants evaluable for the respective time points.||micromoles per liter||Standard Deviation|Mean
658354|NCT01904058|Secondary|Change From Baseline in 5-D Itch Score at Weeks 4, 8, 13, and Last Post -Baseline Visit (Week 13/ET)|The 5-D itch (validated instrument to measure pruritus) scale was developed for the multidimensional quantification of pruritus that is sensitive to change over time. The 5-D itch scale included 5 domains (duration, degree, direction, disability, and distribution of pruritus). The total 5-D score was obtained by scoring each of the domains separately and then summing them together. 5-D total scores ranged between 5 (no pruritus) and 25 (most severe pruritus).|Baseline, Weeks 4, 8, 13 and Last Post-baseline visit (Week 13/ET)|mITT Population. Here, “n” signifies the number of participants evaluable for the respective time points.||units on a scale||Standard Deviation|Mean
658355|NCT01904058|Secondary|Change From Baseline in Alkaline Phosphatase (ALP) at Weeks 4, 8, 13, and Last Post-baseline Visit (Week 13/ET)|Laboratory serum ALP enzyme levels were evaluated using blood samples collected.|Baseline, Weeks 4, 8, 13 and Last Post-baseline (Week 13/ET)|mITT Population. Here, “n” signifies the number of participants evaluable for the respective time points.||units per liter (U/L)||Standard Deviation|Mean
658356|NCT01904058|Secondary|Change From Baseline in Pruritus Using Adult ItchRO Average Daily Scores at Weeks 4, 8, 13, and Last Post-baseline Visit (Week 13/ET)|ItchRO scores had a range from 0 to 10, with 0 representing no itch and 10 representing very severe itching. The highest score between the morning and evening ItchRO reports represented the daily score: a measure of the worst itching over the previous 24-hour period. Adult ItchRO average daily score was the sum of daily scores divided by the number of days adult ItchRO was completed, using the 7 days prior to the reported visit date.|Baseline, Weeks 4, 8, 13 and Last Post-baseline visit (Week 13/ET)|mITT Population. Here, “n” signifies the number of participants evaluable for the respective time points.||units on a scale||Standard Deviation|Mean
658357|NCT01904058|Secondary|Change From Baseline in Pruritus Using Adult ItchRO Weekly Sum Scores at Weeks 4, 8 and 13|ItchRO scores had a range from 0 to 10, with 0 representing no itch and 10 representing very severe itching. The highest score between the morning and evening ItchRO reports represented the daily score: a measure of the worst itching over the previous 24-hour period. The weekly sum score was calculated as the sum of the daily scores for the 7 days prior to the time point being reported: 7 days prior to randomization or 7 days prior to Week 13/ET visit.|Baseline, Weeks 4, 8 and 13|mITT Population. Here, “n” signifies the number of participants evaluable for the respective time points.||units on a scale||Standard Deviation|Mean
658358|NCT01904058|Primary|Change From Baseline in Pruritus Using Adult Itch Reported Outcome (ItchRO) Weekly Sum Score at Week 13/ Early Termination (ET)|Pruritus was assessed using ItchRO measure, administered as an electronic diary (eDiary) which was completed by the participants twice daily (morning and evening). (ItchRO) scores ranged from 0 to 10, with 0 representing no itch and 10 representing very severe itching. The highest score between the morning and evening ItchRO reports represented the daily score: a measure of the worst itching over the previous 24-hour period. The weekly sum score was calculated as the sum of the daily scores for the 7 days prior to the time point being reported: 7 days prior to randomization or 7 days prior to Week 13/ET visit.|Baseline and Week 13/ET|The mITT population included all participants who were randomized, received at least 1 dose of treatment, and had at least 1 post-baseline ItchRO assessment.||units on a scale||Standard Deviation|Mean
658359|NCT01903993|Secondary|DOR (Modified RECIST)|DOR was defined as the duration from the first tumor assessment that supports the participant's objective response (CR or PR, whichever is first recorded) to disease progression or death due to any cause, whichever occurs first.|From the time of randomization to the date of death due to any cause or up to data cut off date: 08 May 2015 (up to 21 months)|ITT population for efficacy analyses included all randomized participants, regardless of whether they received any study drug. Here, number of participants analyzed signifies the number of participants who were evaluable for this outcome measure. The data was planned to be reported for Atezolizumab arm only.||months||95% Confidence Interval|Median
658373|NCT01903863|Secondary|Antithrombin Levels|Compared antithrombin levels in neonates in control versus treatment group|ECMO course (median 198 hours)|||percentage of antithrombin||Inter-Quartile Range|Median
658360|NCT01903993|Secondary|PFS (Modified RECIST)|PFS was defined as the time (in months) between the date of randomization and the date of first documented disease progression or death, whichever occurs first. Disease progression was determined based on investigator assessment using modified RECIST criteria. PD: at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.|From the time of randomization to the date of death due to any cause or up to data cut off date: 08 May 2015 (up to 21 months)|ITT population for efficacy analyses included all randomized participants, regardless of whether they received any study drug. In the efficacy analyses, the ITT population, participants were grouped according to the treatment arm to which they were assigned. The data was planned to be reported for Atezolizumab arm only||months||95% Confidence Interval|Median
658361|NCT01903993|Secondary|ORR (Modified RECIST)|ORR was defined as the percentage of participants with confirmed objective tumor response, CR or PR, as determined by investigator using modified RECIST criteria. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to l< 10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.|From the time of randomization to the date of death due to any cause or up to data cut off date: 08 May 2015 (up to 21 months)|ITT population for efficacy analyses included all randomized participants, regardless of whether they received any study drug. In the efficacy analyses, the ITT population, participants were grouped according to the treatment arm to which they were assigned. The data was planned to be reported for Atezolizumab arm only||percentage of participants||95% Confidence Interval|Number
658362|NCT01903993|Secondary|Duration of Response (DOR)|DOR was defined as the duration from the first tumor assessment that supports the participant's objective response (CR or PR, whichever is first recorded) to disease progression or death due to any cause, whichever occurs first.|From the time of randomization to the date of death due to any cause or up to data cut off date: 01 Dec 2015 (up to 28 months)|ITT population for efficacy analyses included all randomized participants, regardless of whether they received any study drug. Here, number of participants analyzed signifies the number of participants who were evaluable for this outcome measure.||months||95% Confidence Interval|Median
658363|NCT01903993|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time (in months) between the date of randomization and the date of first documented disease progression or death, whichever occurs first. Disease progression was determined based on investigator assessment using response evaluation criteria In solid tumors (RECIST) v1.1. Progressive disease (PD): at least a 20% increase in the sum of diameters of target lesions including baseline In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.|From the time of randomization to the date of death due to any cause or up to data cut off date: 01 Dec 2015 (up to 28 months)|ITT population for efficacy analyses included all randomized participants, regardless of whether they received any study drug. In the efficacy analyses, the ITT population, participants were grouped according to the treatment arm to which they were assigned.||months||95% Confidence Interval|Median
658364|NCT01903993|Secondary|Objective Response Rate (ORR)|ORR was defined as the percentage of participants with confirmed objective tumor response, complete response (CR) or partial response (PR), as determined by investigator using RECIST v1.1 criteria. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.|Baseline until date of death due to any cause or up to data cut off date: 01 Dec 2015 (up to 28 months)|ITT population for efficacy analyses included all randomized participants, regardless of whether they received any study drug. In the efficacy analyses, the ITT population, participants were grouped according to the treatment arm to which they were assigned.||percentage of participants||95% Confidence Interval|Number
658365|NCT01903993|Primary|Overall Survival (OS)|Overall Survival (OS) was defined as the time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as dead at the time of analysis was censored at the date when they were last known to be alive.|From the time of randomization to the date of death due to any cause or up to data cut off date: 01 Dec 2015 (up to 28 months)|ITT population for efficacy analyses included all randomized participants, regardless of whether they received any study drug. In the efficacy analyses, the ITT population, participants were grouped according to the treatment arm to which they were assigned.||months||95% Confidence Interval|Median
658366|NCT01903876|Secondary|Sexual Violence Perpetration|This scale is the Conflict Tactics Scale revised, Sexual Coercion Subscale and assessed the number of sexually coercive/violent behaviors engaged in during the past 6 months. The index ranges from 0 (no engagement in any sexual violence) to 7 (engaged in all 7 sexually violent behaviors).|6 months|For some of the variables in this analysis, there were missing data. ANCOVA performed in SPSS will use a listwise deletion. This resulted in n=87 and n=115 for this analysis.||score on a scale||Standard Error|Mean
658367|NCT01903876|Primary|Prosocial Intervening Behavior|This scale is the Reactions to Offensive Language and Behavior (ROLB) index that measures whether or not men confronted inappropriate behaviors of other men. We used the 7-item self-behavior subscale plus an additional 8 items, which directly reflected the content of RealConsent. A series of 15 potential intervening situations were presented and participants were asked to indicate whether they had experienced this situation in past 6 months (yes/no), and whether they had intervened (yes/no). The scale ranged from 0% (did not intervene anytime) to 100% (intervened every time).|6 months|||percent score on a scale||Standard Error|Mean
658368|NCT01903863|Secondary|Fresh Frozen Plasma Transfusion Requirements|Compared fresh frozen plasma transfusion during ECMO for control versus treatment group|ECMO course (median 198 hours)|||ml/kilogram/ECMO day||Inter-Quartile Range|Median
658369|NCT01903863|Secondary|Platelets Transfusion Requirement|Compared platelet transfusion during ECMO for control versus treatment group|ECMO course (median 198 hours)|||ml/kilogram/ECMO day||Inter-Quartile Range|Median
658370|NCT01903863|Secondary|Time to Therapeutic aPTT|Compared time in hours to goal aPTT for control versus treatment group|ECMO course (median 198 hours)|||hours||Inter-Quartile Range|Median
658371|NCT01903863|Secondary|Red Blood Cell Transfusion|Compared red blood cell transfusion during ECMO for control versus treatment group|ECMO course (median 198 hours)|||ml/kilogram/ECMO day||Inter-Quartile Range|Median
658375|NCT01903863|Primary|ECMO Pump Longevity|The primary endpoint is the ECMO pump longevity (measured in hours). The life of the circuit was defined as start of that circuit to circuit change or decannulation from ECMO for each patient. Circuit life was measured in hours|ECMO course (median 198 hours)|||hours||Inter-Quartile Range|Median
658388|NCT01903460|Secondary|Change From Baseline to Week 13 (End of Treatment) in Pruritus as Measured by The Patient And Observer Itch Reported Outcome (ItchRO) Average Daily Scores|The ItchRO was administered as a twice daily electronic diary (eDiary). Children ≥9 years of age completed the patient ItchRO; those between the ages of 5 and 8 completed the patient ItchRO with the assistance of their caregiver. There was no patient report for subjects under the age of 5. ItchRO scores range from 0 to 4, with the higher score indicating increasing itch severity. ItchRO average daily scores were calculated as the sum of daily scores (ie, the maximum of morning and evening scores) divided by the number of days. The average daily score was calculated by using the 7 days pre-treatment for baseline, and the last 7 days of treatment for Week 13. A negative change from Baseline indicates that itch severity decreased.|Baseline to 13 weeks or end of treatment|The mITT population, defined as all participants in the Safety population who had at least 1 post-baseline efficacy assessment. The Safety population was defined as all participants who were randomly assigned to study treatment and who received any amount of study drug.||units on a scale||Standard Error|Least Squares Mean
658389|NCT01903460|Secondary|Change From Baseline to Week 13 (End of Treatment) in Liver Enzymes|Analysis of liver enzymes included alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP). A negative change from baseline indicates that the level of that enzyme decreased.|Baseline to 13 weeks or end of treatment|The mITT population, defined as all participants in the Safety population who had at least 1 post-baseline efficacy assessment. The Safety population was defined as all participants who were randomly assigned to study treatment and who received any amount of study drug.||U/L||Standard Error|Least Squares Mean
658390|NCT01903460|Primary|Change From Baseline to Week 13 (End of Treatment) in Fasting Serum Bile Acid Level|Participants were required to fast for at least 4 hours; only water was permitted prior to collection. A negative change from baseline indicates that the level of bile acid decreased.|Baseline to 13 weeks or end of treatment|The modified Intent-to-Treat (mITT) population, defined as all participants in the Safety population who had at least 1 post-baseline efficacy assessment. The Safety population was defined as all participants who were randomly assigned to study treatment and who received any amount of study drug.||umol/L||Standard Error|Least Squares Mean
658391|NCT01903265|Secondary|Change From Baseline to Week 12 in FIQ-R Total Score|"The Fibromyalgia Impact Questionnaire (revised) FIQ-R is made up of 3 domains: functional (9 questions), overall (2 questions) and symptoms (10 questions). All questions are based on an 11-point numerical rating scale (NRS) of 0-10, with 10 being worst. Total FIQ-R scores can range from 0-100, with higher scores reflecting worsening status. The patient's total score on the FIQ-R was assessed at Visits 2, 3, 4, 5, and 6 (Week 12). Jump to control was used to replace missing data in each treatment arm."|Baseline, Week 12|Patients in the Intention-to-treat (ITT) population: all randomized patients||units on a scale||Standard Error|Least Squares Mean
658392|NCT01903265|Secondary|Patient Global Impression of Change (PGIC) Responder Status (“Very Much Improved” or “Much Improved” vs All Other Categories) at Week 12|The PGIC is a 7-point scale (1=very much improved; 7=very much worse) that assesses the patient's perception of the overall change in his/her fibromyalgia symptoms since entering the study. Scores of 1 and 2 were considered responders.|Week 12|Patients in the Intention-to-treat (ITT) population: all randomized patients||percentage of participants|||Number
658393|NCT01903265|Secondary|Change From Baseline to Week 12 in PROMIS T-score for Sleep Disturbance|The Patient-Reported Outcome Measurement Information System (PROMIS) sleep disturbance instrument consists of 8 items in which responses are scored 1 to 5 for each item. A higher score on 5 of the 8 items reflects a worse outcome, whereas a higher score on 3 items reflects an improved outcome; therefore, the directionality of the 8 item scores are first synchronized prior to calculation of the total raw score. PROMIS scores are presented as T-scores in which the raw score has been rescaled into a standardized score with a mean of 50 and a standard deviation of 10. Higher T-scores represent more of the concept being measured (in this case, sleep disturbance).|Baseline, Week 12|Patients in the Intention-to-treat (ITT) population: all randomized patients||units on a scale||Standard Error|Least Squares Mean
658394|NCT01903265|Secondary|30% Responder Analysis of IVRS NRS Pain Assessments at Week 12|"The weekly averages of daily pain scores were calculated using the daily, 24-hour-recall, IVRS NRS pain assessments.
Patients who had at least a 30% improvement from baseline to week 12 in weekly average of daily pain scores were considered responders."|Baseline, Week 12|Patients in the Intention-to-treat (ITT) population: all randomized patients.||percentage of participants|||Number
658395|NCT01903265|Primary|Mean Change From Baseline in Weekly Average of Daily Pain Scores at Week 12|Daily pain scores were assessed using a 24-hour recall response provided by each patient via an interactive voice response system (IVRS) daily telephone diary. Average daily pain was measured using an 11-point (0-10) numerical rating scale (NRS), with higher scores representing worse pain. Jump to control was used to replace missing data in each treatment arm.|Baseline, Week 12|Patients in the Intention-to-treat (ITT) population: all randomized patients||units on a scale||Standard Error|Least Squares Mean
658396|NCT01903187|Secondary|Reduction in Ambulatory Blood Pressure (ABP) Parameters|The study enrollment was terminated early by the sponsor. This was not related to any safety issue. At the time enrollment was halted, only 2 treatment group randomizations had occurred, and sham group subjects were exited after their 1 month follow up visit. This was not enough to conduct the analysis.|baseline, 6 months post randomization, and all follow-up timepoints|All subjects||mmHg||Standard Deviation|Mean
658397|NCT01903187|Secondary|Incidence of Achieving ≥ 10 mmHg, ≥ 15 mmHg, and ≥20 mmHg Reductions in OSBP|The study enrollment was terminated early by the sponsor. This was not related to any safety issue. At the time enrollment was halted, only 2 treatment group randomizations had occurred, and sham group subjects were exited after their 1 month follow up visit. This was not enough to conduct the analysis.|6 months post randomization, and all follow-up timepoints|Subjects who received renal denervation||Participants|||Count of Participants
658398|NCT01903187|Secondary|The Number of Subjects That Experience Each Type of MAE|The study enrollment was terminated early by the sponsor. This was not related to any safety issue. At the time enrollment was halted, only 2 treatment group randomizations had occurred, and sham group subjects were exited after their 1 month follow up visit. This was not enough to conduct the analysis.|6 months post randomization|Subjects who received renal denervation||Participants|||Count of Participants
658399|NCT01903187|Secondary|Device or Procedure Related Adverse Events by Severity Post Randomization Through Six (6) Months|The study enrollment was terminated early by the sponsor. This was not related to any safety issue. At the time enrollment was halted, only 2 treatment group randomizations had occurred, and sham group subjects were exited after their 1 month follow up visit. This was not enough to conduct the analysis.|6 months post randomization|Subjects who received renal denervation||Participants|||Count of Participants
658400|NCT01903187|Primary|The Primary Effectiveness Endpoint is the Reduction of Office Systolic Blood Pressure (OSBP) at Six (6) Months Post Randomization Compared to Baseline Between Groups||6 months post randomization|The study enrollment was terminated early by the sponsor. This was not related to any safety issue. At the time enrollment was halted, only 2 treatment group randomizations had occurred, and sham group subjects were exited after their 1 month follow up visit. This was not enough to conduct a comparison between groups.||mmHg||Standard Deviation|Mean
658401|NCT01903187|Primary|The Primary Safety Endpoint Will be the Proportion of Subjects Who Experience Any Major Adverse Event (MAE) as Adjudicated by the Clinical Event Committee (CEC).|The study enrollment was terminated early by the sponsor. This was not related to any safety issue. At the time enrollment was halted, only 2 treatment group randomizations had occurred.|6 months post randomization|All subjects randomized to the EnligHTN procedure||percentage of participants|||Number
658402|NCT01903148|Secondary|Patients With Hb<11||1 day|||participants|||Number
658403|NCT01903148|Secondary|Iron Treatment|Patients with supplementary Iron treatment to ESA|1 day|||participants|||Number
658404|NCT01903148|Secondary|% Patients With Erythropoiesis Stimulating Agents (ESA) Therapy|know the treatments ESA for maintenance of hb levels|1 day|||percentage of participants|||Number
658405|NCT01903148|Secondary|Patients With Hb>12||1 day|||participants|||Number
658409|NCT01903005|Primary|Number of Patients Reporting Treatment-Emergent Serious Adverse Events|Patients reporting treatment-emergent serious adverse events considered either related or not related to treatment with the higher bioavailability BNX sublingual tablets|Day 1 throught week 24|Safety population||participants|||Number
658410|NCT01903005|Primary|Number of Patients Reporting Treatment-Related, Treatment-Emergent Adverse Events|Treatment-emergent adverse events considered related to treatment with the higher bioavailability BNX sublingual tablets|Day 1 through week 24|Safety population||participants|||Number
658411|NCT01903005|Primary|Number of Patients Reporting Treatment-Emergent Adverse Events|Number of patients reporting treatment-emergent adverse events during open-label, extension treatment with higher bioavailability BNX sublingual tablets|Day 1 through week 24|Safety population||participants|||Number
658412|NCT01903005|Secondary|Mean Change From Primary Study Baseline (OX219-006 or OX219-007) for Questions 5-6 of the WPAI:SHP|Mean change from primary study baseline to week 24 of the open-label extension study for questions 5-6 of the WPAI:SHP; Question 5: During the past 7 days, how much did your opioid dependence affect your productivity while you were working?; Question 6: During the past 7 days, how much did your opioid dependence affect your ability to do regular daily activities, other than work at a job?; Questions 5 and 6 of the WPAI:SHP are scored on an 11-point scale (0 = problem had no effect; 10 = problem completely prevented me from doing my work/daily activities)|Week 24|Safety population; patients with missing data were excluded from the analysis and are reflected in the number of participants analyzed||units on a scale||95% Confidence Interval|Mean
658413|NCT01903005|Secondary|Mean Change From Primary Study Baseline (OX219-006 or OX219-007) for Questions 2-4 of the WPAI:SHP|Mean change from primary study baseline to week 24 of the open-label, extension study for questions 2-4 of the WPAI:SHP; Question 2: During the past 7 days, how many hours did you miss from work because of problems associated with your opioid dependence?; Question 3: During the past 7 days, how many hours did you miss from work because of any other reason, such as vacation, holidays, time off to participate in this study?; Question 4: During the past 7 days, how many hours did you actually work?|Week 24|Safety population; patients with missing data were excluded from the analysis and are reflected in the number of participants analyzed||hours||95% Confidence Interval|Mean
658414|NCT01903005|Secondary|Percent Change From Primary Study Baseline (OX219-006 or OX219-007) for Question 1 of the Work Productivity/Activity Impairment: 6-Question Specific Health Problem Questionnaire (WPAI:SHP)|"Question 1 of the WPAI:SHP asks patients to provide a yes or no response to the question Are you employed?; The percentage of patients employed at the end of the 24-week open-label, extension study was calculated by subtracting the percentage of previously employed patients not employed at study end from the percentage of previously unemployed patients who were employed by study end"|Study Endpoint|Safety population; patients with missing data were excluded from the analysis and are reflected in the number of patients analyzed||percentage of patients|||Number
658415|NCT01903005|Secondary|Mean Change From Primary Study Baseline (OX219-006 and OX219-007) in Visual Analog Scale (VAS) Craving Scores|"Mean change from primary study baseline in VAS craving scores during the 24-week open-label, extension study; VAS craving scores range from 0 (no cravings) to 100 mm (most intense craving I have ever had); study endpoint was defined as the last post-baseline value recorded for VAS craving"|Prior to dosing on day 1, at weeks 4, 8, 12, 16, 20, and 24, and at study endpoint|Safety population; patient population at day 1 (n=646) is lower than overall safety population (n=665) due to missing data||units on a scale||95% Confidence Interval|Mean
658416|NCT01903005|Secondary|Mean Change From Primary Study Baseline (OX219-006 or OX219-007) in Subjective Opioid Withdrawal Scale (SOWS) Score|Mean change from primary study baseline in SOWS total scores during the 24-week open-label, extension study; SOWS scores range from 0 to 64, with a lower score being more favorable; study endpoint was defined as the last post-baseline value recorded for SOWS|Prior to dosing on day 1, at weeks 4, 8,12,16, 20, and 24, and at study endpoint|Safety population; patient population at day 1 (n=650) is lower than overall safety population (n=665) due to missing data||units on a scale||95% Confidence Interval|Mean
658417|NCT01903005|Secondary|Mean Change From Primary Study Baseline (OX219-006 or OX219-007) in Clinical Opioid Withdrawal Scale (COWS) Score|Mean change from primary study baseline in COWS total scores during the 24-week open-label, extension study; COWS scores range from 0 to 48, with a lower score being more favorable; study endpoint was defined as the last post-baseline value recorded for COWS|Prior to dosing on day 1, at weeks 4, 8,12,16, 20, 24, and at study endpoint|Safety population; patient population at day 1 (n=658) is lower than overall safety population (n=665) due to missing data||units on a scale||95% Confidence Interval|Mean
658418|NCT01903005|Secondary|Retention in Treatment in the Safety Population|Retention in treatment by visit in the safety population at weeks 4, 8, 12, 16, 20, and 24, defined as the number of patients receiving treatment on the day of the visit (± 5 days for each visit)|Treatment retention was assessed at weeks 4, 8, 12, 16, 20, and 24|Safety population||participants||95% Confidence Interval|Number
658419|NCT01902888|Primary|Primary Safety Endpoint: Number of Serious Adverse Events (Related to Initial Procedure or the Device Itself) That Occur Within 30 Days of the Initial Study Procedure.|30 day serious adverse events related to the initial study procedure or the study device.|30 days following initial study procedure||||||
658420|NCT01902888|Primary|Primary Efficacy Endpoint: The Number of Patients That do Not Have a Failure of Technical Success or Loss of Primary Patency.|A composite of freedom from failure of technical success or loss of primary patency at 12 months|12 months following initial study procedure||||||
658421|NCT01902758|Primary|Time (Minutes) to Complete 2 Miles on a Treadmill||after arriving at high altitude (within 1 hour)|||seconds||Standard Deviation|Mean
658422|NCT01902303|Secondary|Number of Participants for Whom a Recurrent Oral Herpes Episode Initiated With Prodromal Symptoms Were Aborted Before Progressing to a Lesion as Assessed by the Participant|The secondary efficacy endpoint of this study is to determine if a recurrent oral herpes episode initiated with prodromal symptoms is aborted before progressing to a lesion (vesicle stage) via assessing lesion stages by the participant. Any episode of oral herpes that did not reach a vesicle stage or higher by Day 7 (based on evaluator and self-assessments of legion stage) was considered “aborted” or “blocked”. Any episode of oral herpes that reached a vesicle stage or higher by Day 7 was considered a treatment failure.|0 -7 days|158 subjects randomized to treatment. 118 subjects used allocated assigned treatment (62 test article and 56 placebo). 7 subjects failed to complete and 111 completed study. For this secondary analysis (self assessments) 53 subjects noted prodrome occurring on Day 0.||participants with aborted lesions|||Number
658423|NCT01902303|Primary|Number of Participants for Whom a Recurrent Oral Herpes Episode Initiated With Prodromal Symptoms Were Aborted Before Progressing to a Lesion as Assessed by a Trained Evaluator|The primary efficacy endpoint of this study is to determine if a recurrent oral herpes episode initiated with prodromal symptoms is aborted before progressing to a lesion (vesicle stage) via assessing lesion stages by the trained evaluator. Any episode of oral herpes that did not reach a vesicle stage or higher by Day 7 (based on evaluator and self-assessments of legion stage) was considered “aborted” or “blocked”. Any episode of oral herpes that reached a vesicle stage or higher by Day 7 was considered a treatment failure.|Day 0- Day 7|Participants that did not experience prodrome stage as assessed by the evaluator or met major protocol violations were not included in the PP analysis.||participants who had aborted lesions|||Number
658424|NCT01902134|Secondary|Percentage of Responders According to 50% Max TOTPAR (Total Pain Relief)|"Percentage of responders over 8 hours after first dose, according to the 50% maximum total pain relief rule: maximum TOTPAR calculated as the theoretical maximum weighted sum of PAR-VRS (Pain Relief – Verbal Rating Scale: pain relief 0=none, 4=complete) scores.
The analysis was performed combining all randomization arms including placebo into one group, which resulted in the following 4 analysis groups: DKP/TRAM, DEXKETOPROFEN, TRAMADOL, and Placebo."|over 8 hours after the first dose|||percentage of participants|||Number
658425|NCT01902134|Secondary|Percentage of Responders According to PI-VAS (Pain Intensity – Visual Analogue Scale)|"Percentage of responders; response defined as achievement a mean pain intensity, PI-VAS < 40 mm (PI-VAS corresponds to the pain intensity measured by a 0-100 visual analogue scale, 0=no pain to 100=worst pain imaginable),over 48 hours of the multiple-dose phase.
The analysis was performed combining all randomization arms including the same active treatment, which resulted in the following 3 analysis groups: DKP/TRAM, DEXKETOPROFEN, and TRAMADOL."|over 48 hours of the multiple-dose phase|||percentage of participants|||Number
658426|NCT01902134|Secondary|SPID48 (Sum of Pain Intensity Differences Over First 48 Hours of the Multiple-dose Phase)|"Sum of Pain Intensity Differences calculated as the weighted sum of the PI-VAS differences over 48 hours of the multiple-dose phase.
PI-VAS corresponds to the pain intensity measured by a 0-100 visual analogue scale (0=no pain to 100=worst pain imaginable) which was measured every two hours over the first 48 hours of the multiple-dose phase. A higher value in SPID indicates greater pain relief.
The analysis was performed combining all randomization arms including the same active treatment, which resulted in the following 3 analysis groups: DKP/TRAM, DEXKETOPROFEN, and TRAMADOL."|over 48 hours of the multiple-dose phase|||units on a scale||Standard Deviation|Mean
658427|NCT01902134|Primary|SPID8 (Sum of Pain Intensity Differences Over 8 Hours)|"Sum of Pain Intensity Differences calculated as the weighted sum of the PI-VAS differences over 8 hour period. PI-VAS corresponds to the pain intensity measured by a 0-100 visual analogue scale (0=no pain to 100=worst pain imaginable) which was measured at 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, and 8h after the first dose. A higher value in SPID indicates greater pain relief.
The analysis was performed combining all randomization arms including placebo into one group, which resulted in the following 4 analysis groups: DKP/TRAM, DEXKETOPROFEN, TRAMADOL, and Placebo."|over 8 hours after the first dose|||units on a scale||Standard Deviation|Mean
658428|NCT01901588|Secondary|Time to PACU Discharge||Length of PACU stay (around 3 hours on average)|||minutes||Standard Deviation|Mean
658429|NCT01901588|Secondary|Time to Arousal||Length of PACU stay (around 3 hours on average)|||minutes||Standard Deviation|Mean
658430|NCT01901588|Secondary|Percentage of Participants Requiring Post-operative Nausea and Vomiting (PONV) Rescue Medications||Length of PACU stay (around 3 hours on average)|||percentage of participants|||Number
658431|NCT01901588|Secondary|Post-op Pain Interventions||Length of PACU stay (around 3 hours on average)|||number of pain interventions/group|||Number
658432|NCT01901588|Secondary|Percentage of Participants Receiving Pain Medication||Length of PACU stay (around 3 hours on average)|||percentage of participants|||Number
658433|NCT01901588|Primary|Percentage of Patients Experiencing Pediatric Emergence Delirium in Strabismus Surgery||Length of PACU stay (around 3 hours on average)|||percentage of participants|||Number
658434|NCT01901575|Primary|PVC Suppression With Remifentanil Sedation|1 observed suppression of PVC's (PVC's of the same morphology are no longer observed during any 15 minute recording interval) 0 no suppression|duration of the operative procedure, average 2 hours|||participants with PVC suppression|||Number
658435|NCT01901575|Primary|Inhibition of Idiopathic Ventricular Tachycardia|"observation of the anesthetic effect on the inhibition of the ventricular tachycardia in patients undergoing radio-frequency ablation of idiopathic ventricular tachycardia. Patients were continuously monitored for presence of PVC's.
Every 15 minutes patient's heart rhythm (EKG) was documented on the anesthetic record. Presence of PVC's of the same morphology was confirmed by the cardiologist performing the ablation."|duration of the procedure or until the presence of PVC's was no longer required for the cardiologist to complete the ablation, average 2 hours||||||
658436|NCT01901393|Primary|Efficacy of Pain Relief (Pain Intensity With Movement)|"Pain assessed using VAS (Visual Analog Scale, VAS). The VAS is a continuous scale compromised of a horizontal line, one hundred millimeters in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the No Pain anchor and the subject's mark. The score would be between 0 (No Pain) and 100 (Worst Possible Pain)."|First possible time post-surgery, an expected average of 6 hours|This analysis was performed on all subject who completed the VAS with Movement Immediately Following their Procedure||units on a scale (in mm)||Standard Deviation|Mean
658437|NCT01901393|Secondary|Incidence of Serious Adverse Events|Number of subjects experiencing treatment-emergent serious adverse events|Post-operative period until discharge, an expected average of 6 hours|||Number of events|||Number
658438|NCT01901393|Secondary|Patient Satisfaction|Measured using 2 question, 4 point scale.|Post-operative period until discharge, an expected average of 6 hours|||Participants|||Number
658439|NCT01901393|Secondary|Time to First Use of Rescue Med Will be Measured|Time to first rescue medication (in hours) in the postoperative period through discharge.|Post-operative period until discharge, an expected average of 6 hours|||hours||Standard Error|Mean
658440|NCT01901393|Secondary|Rescue Medication Use in Post-operative Period|Amount of rescue medication (in milligrams) will be measured|Post-operative period until discharge, an expected average of 6 hours|||milligrams||Standard Deviation|Mean
658441|NCT01901393|Primary|Efficacy of Pain Relief (Pain Intensity at Rest)|"Pain assessed using VAS (Visual Analog Scale, VAS). The VAS is a continuous scale compromised of a horizontal line, one hundred millimeters in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the No Pain anchor and the subject's mark. The score would be between 0 (No Pain) and 100 (Worst Possible Pain)."|First possible time post-surgery, an expected average of 6 hours|This analysis was performed on all subject who completed the VAS at Rest Immediately Following their Procedure||units on a scale (in mm)||Standard Deviation|Mean
658442|NCT01901341|Other Pre-specified|Cardiovascular, Gastrointestinal and Central Opioid Withdrawal Events|"Cardiovascular (CV) events of interested included myocardial infarction, unstable angina, cardiovascular accident, congestive heart failure, serious arrhythmia, resuscitated cardiac arrest, and death.
Gastrointestinal (GI) events of interest included emergency department visits for SAEs of gastroenteritis, hepatitis, pancreatitis, nausea, vomiting, diarrhea, and abdominal pain or cramping.
Central opioid withdrawal events of interest included opioid withdrawal syndrome."|Baseline through 16 weeks|All participants randomized to treatment who received ≥ 1 dose of double-blind study medication.||participants|||Number
658443|NCT01901341|Secondary|Overall Complete Spontaneous Bowel Movement (CSBM) Responder Rates at 12 Weeks|A CSBM Weekly Responder is a subject who has ≥ 3 CSBMs for the specified week and an increase from baseline of ≥1 CSBM for the week. An Overall CSBM Responder is a subject who is a Weekly CSBM Responder for 9 of the 12 weeks of the double-blind treatment period, including 3 of the last 4 weeks (Weeks 9, 10, 11 and 12).|12 weeks|Zero participants were analyzed, and no data was collected for this measure. Due to lack of enrollment, the study was terminated early.|||||
658444|NCT01901341|Secondary|Change From Baseline of Chronic Opioid-Related Gastrointestinal Symptom Scale (CORGISS) Scores at 12 Weeks|The CORGISS is designed to assess GI symptoms related to opioid use in patients with chronic non-cancer pain. The CORGISS asks participants to rate the severity of GI symptoms over the previous 24 hours, with answers ranging from 0 (“did not experience”) to 4 (“very severe”).|Baseline, 12 weeks|Zero participants were analyzed, and no data was collected for this measure. Due to lack of enrollment, the study was terminated early.|||||
658445|NCT01901341|Primary|Overall Spontaneous Bowel Movement (SBM) Responder Rates at the 12-weeks|A Spontaneous Bowel Movement (SBM) Weekly Responder (calculated for each week of the 12-week double-blind treatment period) is a participant who has ≥ 3 SBMs for the week and an increase from baseline of ≥1 SBM for the specified week, based on at least 4 Available Data Days (ADDs) during the week. For the definition of the primary efficacy endpoint, Overall SBM Responder is a participant who is a Weekly SBM Responder for 9 of the 12 weeks of the double-blind treatment period, including 3 of the last 4 weeks (Weeks 9, 10, 11 and 12).|12 weeks|Zero participants were analyzed, and no data was collected for this measure. Due to lack of enrollment, the study was terminated early.|||||
658446|NCT01901328|Other Pre-specified|Adjudicated Cardiovascular, Gastrointestinal and Central Opioid Withdrawal Events|"Cardiovascular (CV) events of interested included myocardial infarction, unstable angina, cardiovascular accident, congestive heart failure, serious arrhythmia, resuscitated cardiac arrest, and death.
Gastrointestinal (GI) events of interest included emergency department visits for SAEs of gastroenteritis, hepatitis, pancreatitis, nausea, vomiting, diarrhea, and abdominal pain or cramping.
Central opioid withdrawal events of interest included opioid withdrawal syndrome."|Baseline through 16 weeks|||participants|||Number
658447|NCT01901328|Secondary|Overall Complete Spontaneous Bowel Movement (CSBM) Responder Rates at 12 Weeks|A CSBM Weekly Responder is a subject who has ≥ 3 CSBMs for the specified week and an increase from baseline of ≥1 CSBM for the week. An Overall CSBM Responder is a subject who is a Weekly CSBM Responder for 9 of the 12 weeks of the double-blind treatment period, including 3 of the last 4 weeks (Weeks 9, 10, 11 and 12).|12 weeks|Zero participants were analyzed, and no data was collected for this measure. Due to lack of enrollment, the study was terminated early.|||||
658448|NCT01901328|Secondary|Change From Baseline of Chronic Opioid-Related Gastrointestinal Symptom Scale (CORGISS) Scores at 12 Weeks|The CORGISS is designed to assess GI symptoms related to opioid use in patients with chronic non-cancer pain. The CORGISS asks participants to rate the severity of GI symptoms over the previous 24 hours, with answers ranging from 0 (“did not experience”) to 4 (“very severe”).|Baseline, 12 weeks|Zero participants were analyzed, and no data was collected for this measure. Due to lack of enrollment, the study was terminated early.|||||
658449|NCT01901328|Primary|Overall Spontaneous Bowel Movement (SBM) Responder Rates at 12-weeks|A Spontaneous Bowel Movement (SBM) Weekly Responder (calculated for each week of the 12-week double-blind treatment period) is a participant who has ≥ 3 SBMs for the week and an increase from baseline of ≥1 SBM for the specified week, based on at least 4 Available Data Days (ADDs) during the week. For the definition of the primary efficacy endpoint, Overall SBM Responder is a participant who is a Weekly SBM Responder for 9 of the 12 weeks of the double-blind treatment period, including 3 of the last 4 weeks (Weeks 9, 10, 11 and 12).|12 weeks|Zero participants were analyzed, and no data was collected for this measure. Due to lack of enrollment, the study was terminated early.|||||
658450|NCT01901302|Other Pre-specified|Adjudicated Cardiovascular, Gastrointestinal and Central Opioid Withdrawal Events|"Cardiovascular (CV) events of interested included mycardial infarction, unstable angina, cardiovascular accident, congestive heart failure, serious arrhythmia, resuscitated cardiac arrest, and death.
Gastrointestinal (GI) events of interest included emergency department visits for SAEs of gastroenteritis, hepatitis, pancreatitis, nausea, vomiting, diarrhea, and abdominal pain or cramping.
Central opioid withdrawal events of interest included opioid withdrawal syndrome."|Baseline through 16 weeks|All participants randomized to treatment who received ≥ 1 dose of double-blind study medication.||participants|||Number
658451|NCT01901302|Secondary|Overall Complete Spontaneous Bowel Movement (CSBM) Responder Rates at 12 Weeks|A CSBM Weekly Responder is a participant who has ≥ 3 CSBMs for the specified week and an increase from baseline of ≥1 CSBM for the week. An Overall CSBM Responder is a subject who is a Weekly CSBM Responder for 9 of the 12 weeks of the double-blind treatment period, including 3 of the last 4 weeks (Weeks 9, 10, 11 and 12).|12 weeks|Zero participants were analyzed, and no data was collected for this measure. Due to lack of enrollment, the study was terminated early.|||||
658452|NCT01901302|Secondary|Change From Baseline of Chronic Opioid-Related Gastrointestinal Symptom Scale (CORGISS) Scores at 12 Weeks|The CORGISS is designed to assess GI symptoms related to opioid use in patients with chronic non-cancer pain. The CORGISS asks participants to rate the severity of GI symptoms over the previous 24 hours, with answers ranging from 0 (“did not experience”) to 4 (“very severe”).|Baseline, 12 weeks|Zero participants were analyzed, and no data was collected for this measure. Due to lack of enrollment, the study was terminated early.|||||
658453|NCT01901302|Primary|Overall Spontaneous Bowel Movement (SBM) Responder Rates at 12 Weeks|"A Spontaneous Bowel Movement (SBM) Weekly Responder (calculated for each week of the 12-week double-blind treatment period) is a participant who has ≥ 3 SBMs for the week and an increase from baseline of ≥1 SBM for the specified week, based on at least 4 Available Data Days (ADDs) during the week. A Complete SBM (CSBM) Weekly Responder is a participant who has ≥ 3 CSBMs for the specified week and an increase from baseline of ≥1 CSBM for the week.
For the definition of the primary efficacy endpoint, Overall SBM Responder is a participant who is a Weekly SBM Responder for 9 of the 12 weeks of the double-blind treatment period, including 3 of the last 4 weeks (Weeks 9, 10, 11 and 12)."|12 weeks|Zero participants were analyzed, and no data was collected for this measure. Due to lack of enrollment, the study was terminated early.|||||
658454|NCT01901250|Primary|Change in the Number of Decayed or Filled Permanent Teeth (DFT) From Baseline (Beginning of Kindergarten) to the Middle of 2nd Grade|"The primary outcome measure was change in the number of decayed or filled permanent teeth (DFT). Caries was assessed in accordance to the International Caries Detection and Assessment System (ICDAS). The ICDAS criteria record both the severity and activity of the lesion on occlusal surfaces, in pit and fissure sites on the buccal and lingual surfaces, and on other smooth surfaces.
For the purposes of this study, an ICDAS severity score of 3 to 6 and the presence of fillings constituted the D and F portions of DFT, respectively."|baseline and middle of 2nd grade|||Number of surfaces||Standard Deviation|Mean
658455|NCT01901211|Secondary|StepWatch Activity Monitors|StepWatch Activity Monitors will be used to measure activity levels and motor participation. The StepWatch is a two-plane accelerometer that is worn around the ankle in a knit cuff. The StepWatch measures ambulatory activity (i.e. total daily step count) and acts as an indicator of motor participation in the community.|Baseline (1-week pre-study arm 1), 11-weeks (post study arm 1), 17-weeks (post washout period), 28-weeks (post study arm 2)||||||
658456|NCT01901211|Secondary|Gaming Data|Gaming data will be collected as measures of effectiveness of the games' balancing techniques, engagement and adherence. The games will be instrumented to automatically collect usage data including: time and frequency of play; amount of time within HR zones; pedaling cadence information; minigames played; and location of the player's avatar in the virtual world.|10-weeks of the exergaming intervention||||||
658457|NCT01901211|Secondary|The Self-Worth Domain of the KINDL-R Questionnaire|The 4-item Self-worth Domain of the KINDL-R will be used as an indicator of self-esteem.|Baseline (1-week pre-study arm 1), 11-weeks (post study arm 1), 17-weeks (post washout period), 28-weeks (post study arm 2)||||||
658458|NCT01901211|Secondary|Total Score of the KINDL-R Questionnaire|The total score of the 24-item KINDL-R questionnaire will measure the participants' health-related quality of life.|Baseline (1-week pre-study arm 1), 11-weeks (post study arm 1), 17-weeks (post washout period), 28-weeks (post study arm 2)||||||
658459|NCT01901211|Secondary|Anthropometric Measurements|Anthropometric measurements of waist circumference, triceps and subscapular skinfold thickness, height and weight will be used to assess body composition as indicators of physical fitness.|Baseline (1-week pre-study arm 1), 11-weeks (post study arm 1), 17-weeks (post washout period), 28-weeks (post study arm 2)||||||
658460|NCT01901211|Secondary|The 30-second Wingate Cycle Test|The 30-second Wingate Cycle Test is a measure of anaerobic power, a key component of physical fitness. The cycle test is performed when a participant uses a cycle ergometer and pedals as hard as they can for 30-seconds against a constant braking force.|Baseline (1-week pre-study arm 1), 11-weeks (post study arm 1), 17-weeks (post washout period), 28-weeks (post study arm 2)||||||
658461|NCT01901211|Secondary|Handheld Dynamometry Measures of Knee Flexors and Knee Extensors|Handheld dynamometry will be used to measure muscle strength for the quadriceps muscles and the hamstrings at 90˚ of knee flexion in both legs.|Baseline (1-week pre-study arm 1), 11-weeks (post study arm 1), 17-weeks (post washout period), 28-weeks (post study arm 2)||||||
658462|NCT01901211|Primary|Change in the Social Wellbeing Domain of the KINDL-R Quality of Life Questionnaire|Wellbeing Related to Friends/Peers domain of the KINDL-R is a four-item subscale focusing on time spent with friends, being perceived as a success with friends, getting along with friends and whether or not they felt different from peers over the past week. Individual items are scored on a five-point Likert scale and the subscale can be scored in isolation.|Baseline (1-week pre-study arm 1), 11-weeks (post study arm 1), 17-weeks (post washout period), 28-weeks (post study arm 2)||||||
658463|NCT01901211|Primary|Change in the 7.5 Meter Shuttle Run Test for Gross Motor Function Classification Scale (GMFCS) Level III (SRT-III)|The 7.5m Shuttle Run test (SRT-III) is a maximal, running-based, field test that can assess cardiovascular fitness in children with CP GMFCS level III. In the tests, markers are placed 7.5m apart in a square formation. Participants walk from marker to marker according to progressively faster auditory cues from a music device.|Baseline (1-week pre-study arm 1), 11-weeks (post study arm 1), 17-weeks (post washout period), 28-weeks (post study arm 2)|||Change in SRT score||Standard Deviation|Mean
658464|NCT01901185|Other Pre-specified|Number of Participants With Adverse Events, Serious Adverse Events and Adverse Device Events|An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant that does not necessarily have a causal relationship with study treatment or the device under study. The definition includes worsening of a pre-existing medical condition. A serious adverse event is defined as an AE that meets at least 1 of the following serious criteria: • fatal • life threatening • requires or prolongs in-patient hospitalization • results in persistent or significant disability/incapacity • congenital anomaly/birth defect • other medically important serious event. An adverse device effect is any adverse event related to the use of a medical device. Adverse device effects include AEs resulting from insufficient or inadequate instructions for use, malfunction of the device, or from use errors (including errors resulting from normal use, reasonably forseeable misuse or from intentional misuse) of the device.|9 weeks|Safety population||participants|||Number
661151|NCT01845831|Secondary|Number of Participants With a Hypoglycemic Event|The number of participants who had a hypoglycemic event during hospitalization.|Duration of Hospitalization (Up to 10 Days)|||Participants|||Count of Participants
658465|NCT01901185|Secondary|Percentage of Errors in Each Step of the Self-injection Process|For all the nonmissed injections recorded on the Participant Self-injection Questionnaire, the percentage of the following steps in the self-injection process that were not successfully completed out of the total nonmissed injections during Weeks 1 to 5 are reported. If multiple attempts were recorded, all the recorded attempts were considered, regardless whether it was a successful attempt or not. • Error Icon lit up (Question 2) • Could not load cassette successfully (Question 3) • Could not remove purple cassette cap successfully (Question 4) • Could not press start button to begin self-injection successfully (Question 5).|Week 1, Week 2, Week 3, Week 4 and Week 5|Primary analysis set; multiple injection attempts per week are included.||percentage of errors|Participants||Number
658466|NCT01901185|Secondary|Percentage of Autoinjector A System Failures|The autoinjector A and prefilled syringe (PFS)/cassettes used by the participants were examined at the end of the study by device engineers. System failure was defined as the failure of the Autoinjector A or PFS/cassette to meet the device design requirements during Weeks 1 to 5. The percentage of system failures is reported out of the total number of injection attempts during the study, including multiple attempts per week.|Week 1, Week 2, Week 3, Week 4 and Week 5|Primary analysis set; multiple injection attempts per week are included.||percentage of system failures|Participants|95% Confidence Interval|Number
658467|NCT01901185|Primary|Percentage of Successful Self-injections to Total Non-missed Injections|The successful self-injection of etanercept using the Autoinjector A, as evaluated by the percentage of successful injections of the total nonmissed injections administered by participants in the non-health care setting during Weeks 1 to 5. Successful self-injection was assessed by Question 1 in the Participant Self-injection Questionnaire, which was completed by each participant after each self-injection. Successful injection is defined as the Autoinjector A signaling a complete injection and no liquid medication pooled on your skin.|Week 1, Week 2, Week 3, Week 4 and Week 5|Primary analysis set defined as all nonmissed injections using Autoinjector A during Weeks 1 to 5 for all enrolled participants; in the event of multiple injection attempts, only the last attempt per week was counted.||percentage of successful injections|Participants|95% Confidence Interval|Number
658468|NCT01900431|Secondary|Pharmacokinetics (PK) Assessment: Serum Functional Sarilumab Concentration|Serum functional (unbound) sarilumab concentrations were determined using an enzyme-linked immunosorbent assay (ELISA) method with a lower limit of quantification (LLOQ) of 294 ng/mL. Concentrations below LLOQ were set to zero for samples at predose. Post-treatment concentrations below LLOQ were replaced by LLOQ/2. The samples were considered non-eligible for the analysis if the previous dosing time was <11 days or >17 days before the sampling time for every other week regimens.|Predose on Day 1 (Baseline), Week 2, 4, 8, 12, 16, 24, 36, 52, and end of study (EOS) (Week 56)|PK population: all participants who received at least one dose or part of a dose of investigational medicinal product (IMP) with at least one post-dose, non-missing serum concentration value and were analyzed according to treatment actually received. Data of this endpoint was planned to be analyzed for Sarilumab 200 mg q2w arm in Part A and B only.||ng/mL||Standard Deviation|Mean
658469|NCT01900431|Secondary|Percentage of Participants With Prednisone Dose of ≤5 mg/Day (or Equivalent Oral Corticosteroid) at Week 16|Participants with prednisone dose ≤5 mg/day (or equivalent oral corticosteroid) at Week 16 were evaluated.|Week 16|Analysis was performed on mITT population. Number of participants analyzed = participants with non-missing data for prednisone (or equivalent oral corticosteroid) dose at Week 16.||Percentage of participants|||Number
658470|NCT01900431|Secondary|Percentage of Participants Without Retinal Vessel Leakage on Fluorescein Angiography (FA) at Week 16||Week 16|Analysis of this endpoint was not performed as no retinal vessel leakage data was collected at Week 16. Zero participants were analyzed.|||||
658471|NCT01900431|Secondary|Percentage of Participants With CRT Thickness <300 Microns at Week 16||Week 16|This endpoint was replaced by the percent change from baseline in CRT at Week 16 as this is more clinically relevant. Zero participant was analyzed.|||||
658472|NCT01900431|Secondary|Percent Change From Baseline in CRT at Week 16|CRT was measured by SD-OCT, a non-invasive diagnostic system providing high-resolution imaging sections of the retina. All images were transmitted to the central reading center. SD-OCT was performed in the study eye after pupil dilation. LS mean was calculated using MMRM model with treatment groups, randomization strata of VH level (<4, >=4), visits and visit-by-treatment groups interaction as fixed categorical effects, as well as, fixed continuous covariate of baseline CRT.|Baseline to Week 16|Analysis was performed on mITT population. Number of participants analyzed = participants with CRT assessment at baseline and post-baseline visits.||percent change||Standard Error|Least Squares Mean
658473|NCT01900431|Secondary|Change From Baseline in Central Retinal Thickness (CRT) At Week 16|CRT was measured by spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. All images were transmitted to the central reading center. SD-OCT was performed in the study eye after pupil dilation. LS mean was calculated using MMRM model with treatment groups, randomization strata of VH level (<4, >=4), visits and visit-by-treatment groups interaction as fixed categorical effects, as well as, fixed continuous covariate of baseline CRT.|Baseline to Week 16|Analysis was performed on mITT population. Number of participants analyzed = participants with CRT assessment at baseline and post-baseline visits.||µm (microns)||Standard Error|Least Squares Mean
658474|NCT01900431|Secondary|Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at Week 16|BCVA score is based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters, and then at 1 meter. The range of ETDRS is 0 to 100 letters. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. LS mean was calculated using MMRM model with treatment groups, randomization strata of VH level (<4, >=4), visits and visit-by-treatment groups interaction as fixed categorical effects, as well as, fixed continuous covariate of baseline BCVA.|Baseline to Week 16|Analysis was performed on mITT population. Number of participants analyzed = participants with BCVA score assessment at baseline and post-baseline visits.||units on a scale||Standard Error|Least Squares Mean
658639|NCT01897233|Primary|Part A: Observed Plasma Concentration of Lumacaftor (LUM) and Ivacaftor (IVA) at Hour 4 Post-dose (C4h) on Day 1||4 hours post-morning dose on Day 1|The Pharmacokinetic (PK) Set included all enrolled participants who received the study drug and for whom the primary PK data were considered to be sufficient and interpretable.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
658475|NCT01900431|Secondary|Percentage of Participants With Anterior Chamber (AC) Cell Score = 0 or At Least 2-step Reduction in Score at Week 16|Participants with AC cell score = 0 or with ≥2 step reduction from baseline at Week 16 were evaluated. Slit lamp examinations were conducted at each visit to assess AC cell count. The number of AC cells observed within a 1 mm × 1 mm slit beam was used to determine the grade according to the Standardization of Uveitis Nomenclature (SUN) criteria: grade 0 = no cells; grade +0.5 = 1 - 5 cells; grade +1 = 6 - 25 cells; grade +2= 26 - 50 cells; grade +3 = too many to count.|Week 16|Analysis was performed on mITT population. Number of participants analyzed = participants with non-missing AC cell score at Week 16.||Percentage of participants|||Number
658476|NCT01900431|Secondary|Change From Baseline in VH Scale at Week 16|Change from baseline in VH scale was evaluated on Miami 9-step scale. VH is the obscuration of fundus by vitreous cells and protein exudation. Each of the 9-step scale (from grade 0 [low opacity] to 8 [more opacity]) images (in increasing order of opacity) were equivalent to approximately 0.3 log units of degradation in visual acuity based on the Bangerter calibration. Least squares (LS) mean was calculated using mixed model for repeated measurements (MMRM) model with treatment groups, visits and visit-by-treatment groups interaction as fixed categorical effects as well as fixed continuous covariate of baseline adjudicated VH.|Baseline to Week 16|Analysis was performed on mITT population. Number of participants analyzed = participants with VH assessment at baseline and post-baseline visits.||units on a scale||Standard Error|Least Squares Mean
658477|NCT01900431|Primary|Percentage of Participants With at Least 2-step Reduction in Vitreous Haze (VH) or Prednisone Dose <10 mg/Day at Week 16|At least 2-step reduction in VH per central review from baseline was evaluated on Miami 9-step scale. VH is the obscuration of fundus by vitreous cells and protein exudation. Each of the 9-step scale (from grade 0 [low opacity] to 8 [more opacity]) images (in increasing order of opacity) are equivalent to approximately 0.3 log units of degradation in visual acuity based on the Bangerter calibration. Participants with prednisone dose <10 mg/day (or equivalent oral corticosteroid) were also evaluated.|Week 16|Modified intent-to-treat population (mITT) included all randomized participants who received at least 1 injection analyzed according to the group to which the participant was allocated by the randomization schedule. Modified multiple imputation approach was used on VH missing adjudicated scores.||Percentage of participants|||Number
658478|NCT01900314|Secondary|Depression Symptoms at 4 Weeks- Secondary|Depressive symptoms as measured by the 17-item Hamilton Depression Rating Scale (HRSD17) Range: 0-53 Normal: 0-7 Mild: 8 - 13 Moderate 14 - 18 Severe: 19-22 Very severe > 22|4 weeks after baseline|Sample analyzed included all participants who entered the study and received MRI scans at baseline and after 4 weeks of treatment. Repeated measures ANCOVA with screening MADRS score as co-variate||units on a scale||Standard Deviation|Mean
658479|NCT01900314|Primary|Depressive Symptoms at 4 Weeks|MADRS: Montgomery Asberg Depression Rating Scale Range: 0 - 60 0 to 6 – normal/symptom absent 7 to 19 – mild depression 20 to 34 – moderate depression >34 – severe depression|4 weeks after baseline|||units on a scale||Standard Deviation|Mean
658480|NCT01900249|Primary|Change of Corneal Fluorescein Staining of the Inferior Cornea Region.|Change from baseline (Visit 3) of inferior region CFS score at 12 weeks. Inferior region CFS score range 0-4, where '0' represents no fluorescein staining and '4' represents severe staining on the cornea.|Baseline to Week 12|The intent to treat population (ITT) included all randomized subjects who administered study medication. The primary analysis was performed on the ITT population.||units on a scale (Likert)||95% Confidence Interval|Mean
658481|NCT01900067|Primary|The Difference in the Arithmetic Mean of Core Body Temperature Measurements During the Perioperative Phase Between the Interventional Treatment Group and the Control Treatment Group|The subject's core body temperature at any time point is approximated by the arithmetic mean of three repeated tympanic temperature measurements every 15 minutes during the perioperative period|temperature measurments during pre,-intra and postoperative period, on average 1-5 hours, depending on the surgical intervention.|||Degree Celsius (°C)||95% Confidence Interval|Mean
658482|NCT01900054|Secondary|Patient Impression of Nasal Symptoms(Sneezing, Rhinorrhea, Nasal Congestion, Nasal Pruritus, Eye Pruritus and Eye Tearing)||Week 12 or suspension||||||
658483|NCT01900054|Secondary|Influence of Activities in Daily Life(Study, Outing, Sleeping)||Second enrollment, Week2, Week4, Week6, Week8, Week10 and Week 12||||||
658484|NCT01900054|Secondary|Change From Baseline in Severity Score for Symptoms of Allergic Rhinitis||baseline, Week2, Week4, Week6, Week8, Week10 and Week 12||||||
658485|NCT01900054|Secondary|Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings)||Second enrollment, Week2, Week4, Week6, Week8, Week10 and Week 12||||||
658486|NCT01900054|Secondary|Change From Baseline in Individual Nasal Symptom Scores (Sneezing, Rhinorrhea, Nasal Congestion, and Impairment in Daily Activities)||baseline, Week2, Week4, Week6, Week8, Week10 and Week 12||||||
658487|NCT01900054|Secondary|Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] at Week2, Week4, Week6, Week8, Week10, Week 12 and Final Evaluation Point.|Total score for the three major nasal symptoms (sneezing, rhinorrhea, and nasal congestion) were rated on 5-point scale ranging from 0 (no symptom) to 4 (very severe).|Baseline, Week2, Week4, Week6, Week8, Week10, Week 12 and Final Evaluation Point （up to Week 12）|||units on a scale||Standard Deviation|Median
658488|NCT01900054|Primary|Number of Patients With Adverse Events and Adverse Drug Reactions||Up to Week 12|||participants|||Number
658489|NCT01899911|Primary|Composite Outcome Measure: Successful Capture of Peripheral Capillary Oxygen Saturation (SpO2) Level|Successful capture of SpO2 levels - Infrared and red light absorbency was measured and used for SpO2 percentage calculation from both the Vital Signs Patch (VSP) study device and an invasive Blood Arterial Hemoximeter (standard method) to determine the level of accuracy of data obtained from the VSP device when compared data taken from the Arterial Hemoximeter. A comparison was made by calculating the Average Root Mean Square (Arms) and comparing against the Arms error rate limit of less than or equal to 3.5% at a 95% confidence level. The outcome is either positive or negative - this is a composite outcome measure.|within 24 hrs|Peripheral capillary oxygen saturation (SpO2) Measurements Taken on the 12 Participants||participants|||Number
658640|NCT01897025|Secondary|MRI Parameters|active and passive fMRI, DTI, This part of data is still under analyzing.|-2, 0 and 4 weeks||12/2015||||
658641|NCT01897025|Secondary|Box and Block Test|Box and block test was to measure the gross manual dexterity. This part of data is still under analyzing.|pre and post training, and 4 weeks post training||12/2015||||
658490|NCT01899768|Secondary|CAC Agent Imputed Dose Concentration Required to Achieve C2, C5 and C6 at Visits 6 and 7 (Part C)|CAC was performed following the administration of GSK2339345 or placebo at Visits 6 and 7. CA was administered using a dosimeter through a nebulizer pot with flow-limitation. Number of coughs in the first and second 15 sec following each dose of CAC agent were recorded. Inhalation of increased Conc. was continued until the maximum dose was tolerated by the participants or the highest available Conc. was used. CAC agent imputed dose concentration required to achieve C2 (at which 2 coughs were first observed [FO]), C5 (at which 5 coughs were FO) and C6 (at which 6 coughs were FO) are presented. For participants who did not complete the challenge and not reached the endpoint, values were imputed to the next dose in the challenge sequence after stopping. For participants who completed the challenge and had not reached the endpoint, values were imputed to 2000 (=twice the highest dose of CA).|After the administration of GSK2339345 or placebo at Visits 6 and 7 in Part C (up to 2 weeks)|CAC Population||mol/L||Geometric Coefficient of Variation|Geometric Mean
658491|NCT01899768|Secondary|CC Agent Imputed Dose Concentration Required to Achieve C2, C5 and C6 at Visits 4 and 5 (Part B)|CC was performed following the administration of GSK2339345 or placebo at Visits 4 and 5. Capsaicin was administered using a dosimeter through a nebulizer. The number of coughs in the first and second 15 sec following each dose of CC agent were recorded. Inhalation of increased Conc. was continued until the maximum dose was tolerated by the participant or the highest available Conc. was used. CC agent imputed dose concentration required to achieve C2 (at which 2 coughs were first observed [FO]), C5 (at which 5 coughs were FO) and C6 (at which 6 coughs were FO) are presented. For participants who did not complete the challenge and not reached the endpoint, values were imputed to the next dose in the challenge sequence after stopping. For participants who completed the challenge and had not reached the endpoint, values were imputed to 2000 (=twice the highest dose of capsaicin).|After the administration of GSK2339345 or placebo at Visits 4 and 5 in Part B (up to 2 weeks)|CC Population||µmol/L||Geometric Coefficient of Variation|Geometric Mean
658492|NCT01899768|Secondary|CAC Agent Dose Concentration Required to Achieve C2, C5 and C6 at Visits 6 and 7 (Part C)|CAC was performed following the administration of GSK2339345 or placebo at Visits 6 and 7. CA was administered using a dosimeter through a nebulizer pot with flow-limitation. Number of coughs in the first and second 15 sec following each dose of CAC agent were recorded. Inhalation of increased conc. was continued until the maximum dose was tolerated by the participants or the highest available Conc. was used. CAC agent dose concentration required to achieve C2 (2 coughs were first observed [FO]), C5 (5 coughs were FO) and C6 (6 coughs were FO) are presented. All instances of missing values occurred where a participant did not achieved the required number of coughs for a parameter.|After the administration of GSK2339345 or placebo at Visits 6 and 7 in Part C (up to 2 weeks)|CAC population: Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the CAC Population.||mol/L||Geometric Coefficient of Variation|Geometric Mean
658493|NCT01899768|Secondary|CC Agent Dose Concentration Required to Achieve C2, C5 and C6 at Visits 4 and 5 (Part B)|CC was performed following the administration of GSK2339345 or placebo at Visits 4 and 5. Capsaicin was administered using a dosimeter through a nebulizer. The number of coughs in the first and second 15 sec following each dose of CC agent were recorded. Inhalation of increased conc. was continued until the maximum dose was tolerated by the participant or the highest available conc. was used. CC agent dose concentration required to achieve C2 (2 coughs were first observed [FO]), C5 (5 coughs were FO) and C6 (6 coughs were FO) are presented. All instances of missing values occurred where a participant did not achieved the required number of coughs for a parameter.|After the administration of GSK2339345 or placebo at Visits 4 and 5 in Part B (up to 2 weeks)|CC population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the CC Population.||µmol/L||Geometric Coefficient of Variation|Geometric Mean
658494|NCT01899768|Secondary|Mean Number of Cough Counts at Each Dose of the Challenge Agent for the Citric Acid Challenge (CAC)at Visits 6 and 7 (Part C)|Citric acid was administered using a dosimeter through a nebulizer pot with flow-limitation. Inhalation of increased Conc. was continued until the maximum dose was tolerated by the par. or the highest available Conc. was used. The dose-response relationship between the dose of citric acid and cough response was investigated using non-linear mixed effect modelling using Poisson and Negative Binomial distributions. When using a Poisson distribution, there was some evidence for an increase in citric acid ED50 with GSK2339345 of 41.6%, however, this was not confirmed when using a Negative Binomial distribution. The Negative Binomial distribution described the data marginally better, but the dataset was too small to make definitive conclusions. There was no treatment difference in citric acid Emax|After the administration of GSK2339345 or placebo (first and second 15 seconds following each dose) at Visits 6 and 7 in Part C (up to 2 weeks)|CAC Population comprised of participants in the All Subjects Population for whom any CAC data were available for one or both Part C study visits. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).||Cough count||Standard Deviation|Mean
658495|NCT01899768|Secondary|Mean Number of Cough Counts at Each Dose of the Challenge Agent for the Capsaicin Challenge (CC) at Visits 4 and 5 (Part B)|Capsaicin was administered using a dosimeter through a nebulizer pot with flow-limitation. Inhalation of increased concentrations (Conc.) was continued until the maximum dose was tolerated by the par. or highest available Conc. was used. The dose-response relationship between dose of capsaicin and cough response was investigated using non-linear mixed effect modeling using Poisson and Negative Binomial distributions. When using a Poisson distribution, there was some evidence for a reduction in capsaicin Emax with GSK2339345 of 17.6%, however, this was not confirmed when using a Negative Binomial distribution. The Negative Binomial distribution described the data marginally better, but the dataset was too small to make definitive conclusions. There was no treatment difference in capsaicin ED50.|After the administration of GSK2339345 or placebo (first and second 15 seconds following each dose) at Visits 4 and 5 in Part B (up to 2 weeks)|CC population. Population comprised of par. in the All Subjects Population for whom any CC data were available for one or both Part B study visits. Only those participants available at the specified time points we re analyze d (represented by n=X, X in the category titles).||Cough count||Standard Deviation|Mean
658496|NCT01899768|Secondary|Mean Visual Analogue Scale (VAS) Score of Cough Severity and Urge to Cough at the Indicated Time Points at Visits 1, 2 and 3 (Part A)|VAS for urge to cough and severity of cough were recorded prior to first dose and 1 hour following the second dose of GSK2339345 or placebo at Visits 1, 2 and 3.VAS is a 100-mm linear scales on which participants indicated the severity of their cough (0 mm represents no severity and 100 mm maximum severity ever experienced) and urge to cough (0 represents no urge to cough, 100 represents maximum urge to cough ever experienced). Mean of replicate values per participants used where the same treatment taken during different periods.|Prior to first dose and 1hr post second dose at Visits 1, 2 and 3 in Part A (up to 3 weeks)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Scores on a scale||Standard Deviation|Mean
658497|NCT01899768|Secondary|Mean Cough Counts by 15 Min Epoch in Part A|Cough counts (8 hr of recording) were conducted at Visits 1, 2 and 3 (4-hr of post-dose recording for each of the two doses administered). Coughs were counted by a cough monitor fitted to the participant for 8 hr post Dose 1. The first epoch started at the time of the first dose, and the 15 min time periods continued until an epoch ended immediately before the second dose (or 4h after the first dose if earlier). The epochs were then re-started at the start of the second dose at 15 min intervals, finishing with an epoch which ran to 4-hr after the start of the second dose. The cough counts were sum-up by the treatments received by the participants. Mean cough count was calculated per participant if the same treatment was taken during different periods.|Up to 8 hours post-dose at Visits 1, 2 and 3 in Part A (up to 3 weeks)|All Subjects Population. Only those participants with a 15 min cough count value were analyzed.||Cough count||Standard Deviation|Mean
658498|NCT01899768|Secondary|Mean Cough Counts by 30 Min Epoch at Visits 1, 2 and 3 (Part A)|Cough counts (8 hr of recording) were conducted at Visits 1, 2 and 3 (4-hr of post-dose recording for each of the two doses administered). Coughs were counted by a cough monitor fitted to the participant for 8 hr post Dose 1. The first epoch started at the time of the first dose, and the 30 min time periods continued until an epoch ended immediately before the second dose (or 4-hr after the first dose if earlier). The epochs were then re-started at the start of the second dose at 30 min intervals, finishing with an epoch which ran to 4-hr after the start of the second dose. The cough counts were sum-up by the treatments received by the participants. Mean cough count was calculated per participant if the same treatment was taken during different periods.|Up to 8 hours post-dose in Visits 1, 2 and 3 in Part A (up to 3 weeks)|All Subjects Population. Only those participants with a 30 min cough count value were analyzed.||Cough count||Standard Deviation|Mean
658499|NCT01899768|Secondary|Mean Cough Counts by 1 hr Epoch at Visits 1, 2 and 3 (Part A)|Cough counts (8 hr of recording) were conducted at Visits 1, 2 and 3 (4-hr of post-dose recording for each of the two doses administered). Coughs were counted by a cough monitor fitted to the participant for 8 hr post Dose 1. The first epoch started at the time of the first dose, and the 60 min time periods continued until an epoch ended immediately before the second dose (or 4-hr after the first dose if earlier). The epochs were then re-started at the start of the second dose at 60 min intervals, finishing with an epoch which ran to 4-hrs after the start of the second dose. The cough counts were sum-up by the treatments received by the participants. Mean cough count was calculated per participant if the same treatment was taken during different periods. Values were imputed pro-rata if 1 hr epoch is less than 60 min.|Up to 8 hours post-dose at Visits 1, 2 and 3 in Part A (up to 3 weeks)|All Subjects Population. Only those participants with a 1 hr cough count value were analyzed.||Cough count||Standard Deviation|Mean
658500|NCT01899768|Secondary|Total Cough Count Excluding Transient Coughs Over 4 Hours at Visits 1, 2 and 3 (Part A)|Total cough count (8 hr of recording) was conducted at Visits 1, 2 and 3 (4-hrs of post-dose recording for each of the two doses administered). Coughs were counted by a cough monitor fitted to the participants for 8 hr post Dose 1. Total count excluding transient cough over 4-hrs was done by using the sum of first 4-hrs starting from the time of first dose and the second 4-hrs starting at the time of the second dose respectively. Number of coughs excluding transient cough in 0-4 hr and 4-8 hr period was log-e transformed and used for the analysis. Values were imputed pro-rata if 4-hr epoch was less than 4-hrs. Mean of the total cough counts over 4-hrs recorded post dose of every treatment i.e. placebo or GSK2339345 1000 mcg was reported.|Up to 8 hours post-dose at Visits 1, 2 and 3 (Part A)|All Subjects Population. Only participants with at least one 4 hr cough count were analyzed.||Cough count||Standard Error|Geometric Mean
658501|NCT01899768|Secondary|Mean Cough Count Over 4 Hours at Visits 1, 2 and 3 (Part A)|Total cough count (8 hr of recording) was conducted at Visits 1, 2 and 3 (4- hrs of post-dose recording for each of the two doses administered). Coughs were counted by a cough monitor fitted to the participants for 8 hr post Dose 1. The cough count over 4-hrs was done by using the sum of first 4-hrs starting from the time of first dose and the second 4-hrs starting at the time of the second dose respectively. Number of coughs in 0-4 hr and 4-8 hr period was log-e transformed and used for the analysis. Values were imputed pro-rata if 4 hr epoch was less than 4 hr. Mean of the total cough counts over 4-hrs recorded post dose of every treatment i.e. placebo or GSK2339345 1000 mcg was reported.|Up to 8 hours post-dose at Visits 1, 2 and 3 (Part A)|All Subjects Population. Only participants with at least one 4 hr cough count were analyzed.||Cough count||Standard Error|Geometric Mean
658502|NCT01899768|Secondary|Time to Reach the Observed Maximum Concentration (Tmax) of GSK2339345 Following Two Repeated Doses|Tmax is defined as the time to reach the observed maximum GSK2339345concentration following two repeated doses at each visit in Part A. Samples were collected at the following time points: pre-dose; 2 min, 5 min, 10 min, 30 min, 1 hr and 2hr (only after Dose 1) post every dose administered at Visits 1, 2 and 3. FA is the first of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. SA is the second of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A.|From 0-4 hr post each dose administered at Visits 1, 2 and 3 in Part A (up to 3 weeks)|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||Hours||Full Range|Median
658642|NCT01897025|Secondary|Grip Strength|Grip strength was measured using a hand-held dynamometer. This part of data is still under analyzing.|pre- and post-training, and again at 4 weeks post-training||12/2015||||
658503|NCT01899768|Secondary|Maximum Observed Concentration (Cmax) of GSK2339345 Following Two Repeated Doses|Cmax is defined as the maximum observed concentration of GSK2339345 following two repeated doses at each visit in Part A. Samples were collected at the following time points: pre-dose; 2 min, 5 min, 10 min, 30 min, 1 hr and 2hr (only after Dose 1) post every dose administration at Visits 1, 2 and 3. FA is the first of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. SA is the second of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. For Cmax, NCs were imputed prior to derivation of summary statistics and NCs were imputed with 0.5*LLQ (LLQ=0.20 ng/mL).|From 0-4 hr post each dose administered at Visits 1, 2 and 3 in Part A (up to 3 weeks)|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
658504|NCT01899768|Secondary|Area Under the Concentration (AUC) Time (0-1) and AUC(0-t) of GSK2339345 Following Two Repeated Doses|AUC curve from time zero (pre-dose) to 1 hours AUC(0-1) and from time zero to the last time AUC(0-t) of quantifiable concentration of GSK2339345 following the first dose and second dose at each visit in Part A was measured. Samples were collected at the following time points: pre-dose; 2 min, 5 min, 10 min, 30 min, 1 hr and 2hr (only after Dose 1) post every dose administration at Visits 1, 2 and 3. For , AUC(0-1) and AUC(0-t), non calculable (NC) were imputed prior to derivation of summary statistics and NCs were imputed as 0.1093 and 0.0855 respectively (=half the lowest observed value).|From 0-4 hr post each dose administered at Visits 1, 2 and 3 in Part A (up to 3 weeks)|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the PK Population.||hour*nanogram per milliliter (h*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
658505|NCT01899768|Secondary|Plasma Concentrations of GSK2339345 at the Indicated Time Points at Visits 1, 2 and 3 (Part A)|Plasma concentrations of GSK2339345 following the first dose and second dose at each visit in Part A was measured. Samples were collected at the following time points: pre-dose, 2 min, 5 min, 10 min, 30 min, 1 hr and 2 hr (only after Dose 1) after each dose administration at Visits 1, 2 and 3. All non-quantifiable (NQ) values after the pre-first dose value imputed to half lower limit of quantification (LLQ) (LLQ=0.2 nanogram per milliliter [ng/mL]). Different participants may have been analyzed for different parameters, so the overall number of par. analyzed reflects everyone in the pharmacokinetic population.|From 0-4 hr post each dose administered at Visits 1, 2 and 3 in Part A (up to 3 weeks)|The Pharmacokinetic (PK) Population comprised of participants in the All Subjects Population for whom a pharmacokinetic sample was obtained and analysed. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).||nanogram per milliliter (ng/mL)||Full Range|Median
658506|NCT01899768|Secondary|Mean Transient Cough Counts at the Indicated Time Points in Part A|Cough counts (8 hours of recording) was conducted at Visits 1, 2 and 3 (4 hours of post-dose recording for each of the two doses administered). Coughs was counted by a cough monitor fitted to the participants for 8 hours post Dose 1. Transient coughing was calculated as the total number of coughs experienced in the two minutes from the start of the first inhalation of a dose. FA is the first of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. SA is the second of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A|0-4 hr, 4-8 hr, 0-8 hr post each dose at Visits 1, 2 and 3 in Part A (up to 8 weeks)|All Subjects Population.Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Cough count||Standard Deviation|Mean
658507|NCT01899768|Secondary|Number of Participants With Perception of Change in Oropharyngeal Sensation at the Indicated Time Points in Part A|The perception of change in oropharyngeal sensation was assessed by a 4 point scale where participants were asked to describe sensitivity and perception of numbness and the responses were recorded. The following information was collected: 0 = no anaesthesia (A), 1 = mild anaesthesia, 2 = moderate anaesthesia and 3 = severe anaesthesia. Oropharyngeal examination was performed at 2 min, 5 min, 15 min, 30 min, 1 hr and 2 hr after FA and SA in Part A. FA is the first of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. SA is the second of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A|From 2 min -2 hr post each dose administered at Visits 1, 2 and 3 in Part A (up to 8 weeks)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Participants|||Number
658508|NCT01899768|Secondary|Mean Forced Expiratory Volume in One Second (FEV1) Values at the Indicated Time Points in Parts A, B and C|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured by spirometry at pre-dose and 30 min after FA and SA in Part A and each administration in Parts B, and C. FA is the first of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. SA is the second of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A.|Pre-dose and 30 min post each dose administered in Parts A, B and C (up to 8 Weeks)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Liters||Standard Deviation|Mean
658541|NCT01899144|Secondary|Baseline-Adjusted Area-Under-The- Forced Expiratory Volume In 1 Second (FEV1) Versus Time Curve Over 6 Hours Post-Dose (FEV1 AUC0-6)|FEV1 AUC0-6 was calculated using the linear trapezoidal rule, and baseline adjustment was made by subtracting the average of the 2 pre-dose FEV1 values from each post-dose FEV1 determination.|Treatment visits 1-5 (approximately days 1, 6, 11, 16, and 21); -35 and -5 minutes prior to dosing and 5 (±2), 15 (±5), 30 (±5), 45 (±5), 60 (±5), 120 (±5), 180 (±5), 240 (±5), 300 (±5), and 360 (±5) minutes after the completion of study drug administrati|Full analysis set||L*hour||Standard Error|Mean
658509|NCT01899768|Secondary|Mean Troponin I Values at the Indicated Time Points in Part A|Blood samples were collected for the measurement of troponin I at pre-dose and 1 hr after each dose of FA and SA in Part A. FA is the first of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. SA is the second of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. Cardiac troponin values that were below the quantification limit [0.02 or 0.04 microgram (mcg/L)] were imputed as 0.01 (mcg/L).|Pre-dose and 1 hr post each dose administered in Part A (up to 3 Weeks)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||mcg/L||Standard Deviation|Mean
658510|NCT01899768|Secondary|Mean Calcium, Chloride, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at the Indicated Time Points in Part A|Blood samples were collected for the measurement of calcium, chloride, glucose, potassium, sodium, and urea/blood urea nitrogen (BUN) at pre-dose and 1 hr after each dose of FA and SA in Part A. FA is the first of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. SA is the second of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A.|Pre-dose and 1 hr post each dose administered in Part A (up to 3 Weeks)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Millimoles per liter (mmol/L)||Standard Deviation|Mean
658511|NCT01899768|Secondary|Mean Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Values at the Indicated Time Points in Part A|Blood samples were collected for the measurement ofdirect bilirubin, total bilirubin, creatinine and uric acid at pre-dose and 1 hr after each dose of FA and SA in Part A. FA is the first of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. SA is the second of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A.|Pre-dose and 1 hr post each dose administered in Part A (up to 3 Weeks)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Micromoles per liter (µmol/L)||Standard Deviation|Mean
658512|NCT01899768|Secondary|Mean Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Values at the Indicated Time Points in Part A|Blood samples were collected for the measurement of ALP, ALT, AST and GGT at pre-dose and 1 hr after each dose of FA and SA in Part A. FA is the first of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. SA is the second of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A.|Pre-dose and 1 hr post each dose administered in Part A (up to 3 Weeks)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||International Units/Liter (IU/L)||Standard Deviation|Mean
658513|NCT01899768|Secondary|Mean Red Blood Cell Count Values at the Indicated Time Points in Part A|Blood samples were collected for the measurement of red blood cell count at pre-dose and 1 hr after each dose of FA and SA in Part A. FA is the first of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. SA is the second of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A.|Pre-dose and 1 hr post each dose administered in Part A (up to 3 Weeks)|All subject population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||10^12 cells per liter (TI/L)||Standard Deviation|Mean
658514|NCT01899768|Secondary|Mean Corpuscle Volume Values at the Indicated Time Points in Part A|Blood samples were collected for the measurement of mean corpuscle volume at pre-dose and 1 hr after each dose of FA and SA in Part A. FA is the first of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. SA is the second of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A|Pre-dose and 1 hr post each dose administered in Part A (up to 3 Weeks)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||femtoliters per cell (fL)||Standard Deviation|Mean
658515|NCT01899768|Secondary|Mean Corpuscle Hemoglobin Values at the Indicated Time Points in Part A|Blood samples were collected for the measurement of mean corpuscle hemoglobin at pre-dose and 1 hr after each dose of FA and SA in Part A. FA is the first of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. SA is the second of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A.|Pre-dose and 1 hr post each dose administered in Part A (up to 3 Weeks)|All subject population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||picograms per cell (pg)||Standard Deviation|Mean
658516|NCT01899768|Secondary|Mean Hematocrit Values at the Indicated Time Points in Part A|Blood samples were collected for the measurement of hematocrit at pre-dose and 1 hr after each dose of FA and SA in Part A. FA is the first of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. SA is the second of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A.|Pre-dose and 1 hr post each dose administered in Part A (up to 3 Weeks)|All subject population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Proportion of one||Standard Deviation|Mean
658608|NCT01897792|Secondary|Mean Number of Days in ICU.|the mean number of days each subject was in the ICU in each arm|from enrollment up to 60 days post enrollment|||days||Full Range|Mean
658517|NCT01899768|Secondary|Mean Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC), Albumin and Total Protein Values at the Indicated Time Points in Part A|Blood samples were collected for the measurement of hemoglobin, MCHC, albumin and total protein at pre-dose and 1 hr after each dose of FA and SA in Part A. FA is the first of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. SA is the second of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A.|Pre-dose and 1 hr post each dose administered in Part A (up to 3 Weeks)|All subject population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Grams per liter (G/L)||Standard Deviation|Mean
658518|NCT01899768|Secondary|Mean Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cells (WBC) Count Values at the Indicated Time Points in Part A|Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, total neutrophils (ANC - absolute neutrophil count), platelet count, and white blood cells count at pre-dose and 1 hr after each dose of FA and SA in Part A. FA is the first of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. SA is the second of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A.|Pre-dose and 1 hr post each dose administered in Part A (up to 3 Weeks)|All subject population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||10^9 cells/Liter (GI/L)||Standard Deviation|Mean
658519|NCT01899768|Secondary|Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings in Parts A, B and C|A 12-lead ECG was recorded in a seated position after the participant was kept at rest in this position for at least 10 minutes. ECGs were obtained at pre-dose and 5 min, 15 min (only in Part A) 30 min, and 1 hr after FA and SA in Part A and each administration in Parts B, and C. FA is the first of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. SA is the second of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. Data are presented as clinically significant (CS) or not clinically significant (NCS) abnormal findings any time during study. The study investigator determined if the abnormal ECG finding was CS or NCS.|Pre-dose and 5min to 1 hr after each dose administered in Parts A, B and C (up to 8 Weeks)|All subject population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Participants|||Number
658520|NCT01899768|Secondary|Mean Body Temperature at the Indicated Time Points in Parts A, B and C|Body temperature measurements were obtained at1 hr post-dose 2 FA and SA in Part A and each administration in Parts B, and C. FA is the first of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. SA is the second of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A.|1 hr post the second dose administered in Part A and 1 hr post each dose administered in Parts B and C (up to 8 Weeks)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Degree Celsius||Standard Deviation|Mean
658521|NCT01899768|Secondary|Mean Heart Rate at the Indicated Time Points in Parts A, B and C|Heart rate measurements were obtained at following time points: pre-dose, 5 min, 15 min (only in Part A), 30 min, and 1 hr after FA and SA in Part A and each dose administration in Parts B and C. FA is the first of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. SA is the second of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. Pre-Dose is the average of the triplicate readings taken at the pre-dose assessment.|Pre-dose, 5 min, 15 min (only in Part A), 30 min, and 1 hr after each dose administered in Parts A, B and C (up to 8 weeks)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Beats per minute||Standard Deviation|Mean
658522|NCT01899768|Secondary|Mean Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points in Parts A, B and C|Systolic blood pressure (SBP) and diastolic blood pressure (DBP) measurements were obtained at following time points: pre-dose, 5 minutes (min), 15 min (only in Part A), 30 min, and 1 hr after first administration (FA) and second administration (SA) in Part A and each dose administration of Parts B and C. FA is the first of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. SA is the second of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. Pre-Dose is the average (avg) of the triplicate readings taken at the pre-dose assessment.|Pre-dose, 5 min, 15 min (only in Part A), 30 min, and 1 hr post each dose administered in Parts A, B and C (up to 8 weeks)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Millimeter of mercury (mmHg)||Standard Deviation|Mean
658523|NCT01899768|Secondary|Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs)|An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, or is an important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or a drug-induced liver injury.|From the start of study treatment and until the follow-up contact (up to 8 Weeks)|All Subjects Population||participants|||Number
658524|NCT01899768|Primary|Total Cough Count Excluding Transient Coughs Over 8 Hours at Visits 1, 2 and 3 (Part A)|Total cough count (8 hr of recording) was conducted at Visits 1, 2 and 3. Coughs were counted by a cough monitor fitted to the participants for 8 hr post Dose 1. The cough count was calculated as the sum of two four hour cough count totals, with the first 4-hrs starting from the time of the first dose and the second four hours starting at the time of the second dose. The cough counts were sum-up by the treatments received by the participants. Transient cough was the total number of coughs experienced in the two mins from the start of the first inhalation of a dose. Number of coughs excluding transient cough in 8 hr period was loge transformed and used for the analysis. Values were imputed pro-rata if 8 hr epoch was less than 8 hr. Mean of the total cough counts excluding transient cough recorded post dose of every treatment i.e. placebo or GSK2339345 1000 mcg was reported.|Up to 8 hours post-dose at Visits 1, 2 and 3 (Part A)|All Subjects Population. Only participants with at least one 8 hr cough count were analyzed.||Cough count||Standard Error|Geometric Mean
658525|NCT01899768|Primary|Total Cough Count Over 8 Hours at Visits 1, 2 and 3 (Part A)|Total cough count (8 hours [hr] of recording) was conducted at Visits 1, 2 and 3. Coughs were counted by a cough monitor fitted to the participants for 8 hr post Dose 1. The cough count was calculated as the sum of two four hour cough count totals, with the first four hours starting from the time of the first dose and the second four hours starting at the time of the second dose. The cough counts were sum-up by the treatments received by the participants. Number of coughs in 8 hr period was loge transformed and used for the analysis. Values were imputed pro-rata if 8 hr epoch was less than 8 hr. Mean of the total cough counts recorded post dose of every treatment i.e. placebo or GSK2339345 1000mcg was reported.|Up to 8 hours post-dose at Visits 1, 2 and 3 (Part A)|All Subjects Population comprised of all participants who receive at least one dose of study medication. Only participants with at least one 8 hr cough count were analyzed.||cough count||Standard Error|Geometric Mean
658526|NCT01899742|Secondary|Change From BL in FEV1 at 3 Hours Postdose on Day 84|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in 1 second. FEV1 assessments taken on 0 to 3 hour on Day 84 (pre-dose, 5 minutes (min), 15 min, 30 min, 1 hour, and 3 hour post-dose). Pre-dose was the reading obtained at 24 hours after the previous day’s dose (Day 83 dose). BL is defined as mean of the values measured 23 hour and 24 hour after dosing prior to Day 1 (ie. after the last OL tiotropium dosing and prior to the randomized dose). Change from BL is defined as the post-BL value minus the BL value. Analysis performed using mixed model repeated measures with covariates of treatment, BL FEV1, center group, 24 hour subset flag, time, time by treatment interaction and time by BL interaction. Only those participants with data available at the specified time point were included in the analysis.|Baseline and Day 84|ITT Population||Liters||Standard Error|Least Squares Mean
658527|NCT01899742|Primary|Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) on Day 85 (Visit 8)|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in 1 second. BL was the mean of the values measured 23 hour and 24 hour after dosing prior to Day 1 (ie. after the last open label [OL] tiotropium dosing and prior to the randomized dose). Change from BL is defined as the post-BL value minus the BL value. Trough FEV1 on Day 85 is defined as the mean of the FEV1 values obtained at 23 and 24 hours after dosing on Day 84 (at Week 12 + 1 day). Analysis performed using a mixed repeated measures model (MMRM) with covariates of treatment, BL, center group, 24 hour subset flag, Day, Day by BL and Day by treatment interactions. ITT Population is defined as participants who received at least one dose of randomized study medication in the treatment period. Only those participants with data available at the specified time point were included in the analysis.|Baseline (BL) and Day 85|ITT Population||Liters||Standard Error|Least Squares Mean
658528|NCT01899677|Primary|Interferon Levels at 28+/-2 Days||28+/-2 days|||pg/ml||Inter-Quartile Range|Median
658529|NCT01899677|Primary|Interferon Levels at 14+/-2 Days||14+/-2 days|||pg/ml||Inter-Quartile Range|Median
658530|NCT01899677|Primary|Interferon Levels at 0+2 Days||0+2 days|||pg/ml||Inter-Quartile Range|Median
658531|NCT01899677|Primary|Interleukin 17A Levels at 28+/-2 Days||28+/-2 days|||pg/ml||Inter-Quartile Range|Median
658532|NCT01899677|Primary|Interleukin 17A Levels at 14+/- 2 Days||14+/- 2 days|||pg/ml||Inter-Quartile Range|Median
658533|NCT01899677|Primary|Interleukin 17A Levels at 0+2 Days||0+2 days|||pg/ml||Inter-Quartile Range|Median
658534|NCT01899677|Primary|Interleukin 10 Levels at 28+/-2 Days||28+/-2 days|||pg/ml||Inter-Quartile Range|Median
658535|NCT01899677|Primary|Interleukin 10 Levels at 14+/- 2 Days||14+/- 2 days|||pg/ml||Inter-Quartile Range|Median
658536|NCT01899677|Primary|Interleukin 10 Levels at 0+2 Days||0+2 days|||pg/ml||Inter-Quartile Range|Median
658537|NCT01899677|Primary|Interleukin 5 Levels at 28+/-2 Day||28+/-2 day|||pg/ml||Inter-Quartile Range|Mean
658538|NCT01899677|Primary|Interleukin 5 Levels on 14+/-2 Day||14+/-2 day|||pg/ml||Inter-Quartile Range|Median
658539|NCT01899677|Primary|Interleukin 5 Serum Cytokine Level on 0+2 Day||0+2 day|||pg/ml||Inter-Quartile Range|Median
658540|NCT01899144|Secondary|Participants With Treatment-Emergent Adverse Events|"Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator as mild (no limitation of usual activities), moderate, or severe (inability to carry out usual activities).
Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes."|Day 1 up to Day 35|The safety population included all randomized patients who received at least 1 dose of randomized study medication. In this population, treatment was assigned based upon the treatment patients actually receive regardless of the treatment to which they were randomized.||participants|||Number
658609|NCT01897792|Secondary|Mean Number of Ventilator-free Days for Subjects|The mean number of ventilator free days (not on ventilator) for subjects in each arm|from enrollment up to 60 days post enrollment|||days||Full Range|Mean
658610|NCT01897792|Secondary|Number of Subjects With 60-day Survival|Number of subjects in each arm that survived to day 60|from enrollment up to 60 days post enrollment|||participants|||Number
658542|NCT01899144|Primary|Baseline-Adjusted Area-Under-The-Percent-Predicted Forced Expiratory Volume In 1 Second (FEV1) Versus Time Curve Over 6 Hours Post-Dose|"Percent predicted FEV1: measured FEV1 as a percent of the predicted values for the patients of similar characteristics. Predicted FEV1 values were computed and adjusted for age, height, and gender for patients aged 4-5 years (Eigen et al 2001) and for patients aged 6-11 years (Quanjer et al 1995) using ATS/European Thoracic Society (ERS) criteria applicable to pediatric patients (ATS/ERS 2007).
The percent predicted FEV1 (PPFEV1) area under the curve (AUC)0-6 was calculated using the linear trapezoidal rule, and baseline adjustment was made by subtracting the average of the 2 pre-dose PPFEV1 values from each post-dose PPFEV1 determination."|Treatment visits 1-5 (approximately days 1, 6, 11, 16, and 21); -35 and -5 minutes prior to dosing and 5 (±2), 15 (±5), 30 (±5), 45 (±5), 60 (±5), 120 (±5), 180 (±5), 240 (±5), 300 (±5), and 360 (±5) minutes after the completion of study drug administrati|Full analysis set (FAS) included all participants in the ITT population who received at least 1 dose of study medication, had a baseline assessment, and had at least 1 post baseline assessment.||%predicted FEV1*hour||Standard Error|Mean
658543|NCT01898884|Secondary|Renal Clearance at Steady State (CLR,ss) of VP 20629 for Multiple Dose Groups|The CLR,ss is the renal clearance of the drug, calculated as Ae/AUC(0-infinity) on Day 8.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 and 48 hours Postdose on Day 8|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N is number of participants analyzed for this outcome measure."||liter per hour||Standard Deviation|Mean
658544|NCT01898884|Secondary|Percentage of Drug Excreted in Urine at Steady-State (Ae%,ss) of VP 20629 for Multiple Dose Groups|The Ae%,ss is the percentage of drug dose excreted into the urine calculated as (Ae divided by dose)∗100.|0-4, 4-8, 8-16, 16-24, 24-36, and 36-48 hours postdose on Day 8|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N is number of participants analyzed for this outcome measure."||percentage of dose||Standard Deviation|Mean
658545|NCT01898884|Secondary|Cumulative Amount Excreted Into the Urine at Steady State (Ae,ss) of Unchanged VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups|The Ae,ss is the amount of drug excreted in urine. It is calculated by multiplying the urinary volume with the urinary drug concentration.|0-4, 4-8, 8-16, 16-24, 24-36, and 36-48 hours postdose on Day 8|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N is number of participants analyzed for this outcome measure."||microgram||Standard Deviation|Mean
658546|NCT01898884|Secondary|Elimination Rate Constant (Lambda[z]) of VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups|Lambda(z) is first-order elimination rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 and 48 hours Postdose on Day 8|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N is number of participants analyzed for this outcome measure."||per hour||Standard Deviation|Mean
658547|NCT01898884|Secondary|Total Body Drug Clearance at Steady State (CLss/F) of VP 20629 for Multiple Dose Groups|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 and 48 hours Postdose on Day 8|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N is number of participants analyzed for this outcome measure."||liter per hour||Standard Deviation|Mean
658548|NCT01898884|Secondary|Volume of Distribution (Vz/F) of VP 20629 for Multiple Dose Groups|The Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 and 48 hours Postdose on Day 8|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N is number of participants analyzed for this outcome measure."||liter||Standard Deviation|Mean
658549|NCT01898884|Secondary|Terminal Plasma Half-Life (t1/2) of VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups|The elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 and 48 hours Postdose on Day 8|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N is number of participants analyzed for this outcome measure."||hour||Standard Deviation|Mean
658550|NCT01898884|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUCt) of VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups|The AUCtau is the measure of the plasma drug concentration from time zero to time t.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 and 48 hours Postdose on Day 8|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N (Number of participants analyzed) and n are number of participants analyzed for this outcome measure and for the specified compound, respectively."||h*ng/mL||Standard Deviation|Mean
658551|NCT01898884|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC[0-8]) of VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups|The AUC(0-8) is the area under the plasma concentration-time curve from time zero to 8 hours postdose.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6 and 8 hours Postdose on Day 1|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, n is number of participants analyzed for this outcome measure at given time points."||h*ng/mL||Standard Deviation|Mean
658552|NCT01898884|Secondary|Area Under the Plasma Concentration Versus Time Curve at Steady State (AUCss) of VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups|The AUCss is the area under the plasma concentration time curve observed during a dosing at steady state.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, and 8 hours Postdose on Day 8|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N is number of participants analyzed for this outcome measure."||h*ng/ml||Standard Deviation|Mean
658611|NCT01897792|Secondary|Number of Subjects Surviving to Day 28|Number of subjects that survived to day 28 after enrollment|from enrollment up to 28 days post enrollment|||participants|||Number
658553|NCT01898884|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC) of VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups|The AUC is the area under the plasma concentration-time curve observed.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 and 48 hours Postdose on Day 8|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N is number of participants analyzed for this outcome measure."||h*ng/ml||Standard Deviation|Mean
658554|NCT01898884|Secondary|Time of Maximum Observed Plasma Concentration at Steady State (Tmax,ss) of VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups|The Tmax,ss is the time to reach maximum observed plasma concentration at steady state of multiple dose of VP 20629 and VP 20631.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 and 48 hours Postdose on Day 8|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N (Number of participants analyzed) and n are number of participants analyzed for this outcome measure and for the specified compound, respectively."||hour||Standard Deviation|Mean
658555|NCT01898884|Secondary|Time of Maximum Observed Plasma Concentration (Tmax) of VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups|The Tmax is the time to reach maximum observed plasma concentration of multiple dose of VP 20629 and VP 20631.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 24 and 72 hours Postdose on Day 1|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N (Number of participants analyzed) and n are number of participants analyzed for this outcome measure and for the specified compound, respectively."||hour||Standard Deviation|Mean
658556|NCT01898884|Secondary|Maximum Observed Serum Concentration at Steady State (Cmax,ss) of VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups|The Cmax,ss is the maximum observed plasma concentration at steady state.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 and 48 hours Postdose on Day 8|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N (Number of participants analyzed) and n are number of participants analyzed for this outcome measure and for the specified compound, respectively."||ng/mL||Standard Deviation|Mean
658557|NCT01898884|Secondary|Maximum Observed Serum Concentration (Cmax) of VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups|The Cmax is the maximum observed plasma concentration of Multiple Dose of VP 20629 and VP 20631.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 24 and 72 hours Postdose on Day 1|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N (Number of participants analyzed) and n are number of participants analyzed for this outcome measure and for the specified compound, respectively."||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
658558|NCT01898884|Secondary|Renal Clearance (CLR) of VP 20629 for Single Dose Groups|The CLR is the renal clearance of the drug, calculated as Ae/AUC(0-infinity) on Day 1 or Ae(0-24)/AUC(0-24) on Day 1.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8,10, 12, 24 and 48 hours Postdose on Day 1|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N is number of participants analyzed for this outcome measure."||liter per hour||Standard Deviation|Mean
658559|NCT01898884|Secondary|Percentage of Drug Excreted in Urine (Ae%) of VP 20629 for Single Dose Groups|The Ae% is the percentage of drug dose excreted into the urine calculated as (Ae divided by dose)∗100.|-4, 4-8, 8-16, 16-24, 24-36 and 36-48 hours postdose on Day 1|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N is number of participants analyzed for this outcome measure."||percentage of dose||Standard Deviation|Mean
658560|NCT01898884|Secondary|Cumulative Amount Excreted Into the Urine (Ae) for Unchanged VP 20629 and Its Metabolite (VP 20631) for Single Dose Groups|The Ae is the amount of drug excreted in urine. It is calculated by multiplying the urinary volume with the urinary drug concentration.|0-4, 4-8, 8-16, 16-24, 24-36 and 36-48 hours postdose on Day 1|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N is number of participants analyzed for this outcome measure."||microgram (mcg)||Standard Deviation|Mean
658561|NCT01898884|Secondary|Elimination Rate Constant (Lambda[z]) of VP 20629 and Its Metabolite (VP 20631) for Single Dose Groups|Lambda(z) is first-order elimination rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8,10, 12, 24 and 48 hours Postdose on Day 1|The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations.||per hour||Standard Deviation|Mean
658562|NCT01898884|Secondary|Total Body Drug Clearance (CL/F) of VP 20629 for Single Dose Groups|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8,10, 12, 24 and 48 hours Postdose on Day 1|The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations.||liter per hour||Standard Deviation|Mean
658563|NCT01898884|Secondary|Volume of Distribution (Vz/F) of VP 20629 for Single Dose Groups|The Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8,10, 12, 24 and 48 hours Postdose on Day 1|The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations.||Liter||Standard Deviation|Mean
658564|NCT01898884|Secondary|Terminal Plasma Half-Life (t1/2) of VP 20629 and Its Metabolite (VP 20631) for Single Dose Groups|The elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8,10, 12, 24 and 48 hours Postdose on Day 1|The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations.||hour||Full Range|Median
658565|NCT01898884|Secondary|Area Under the Plasma Concentration Versus Time Curve to the Last Measurable Plasma Concentration (AUCt) of VP 20629 and Its Metabolite (VP 20631) for Single Dose Groups|The AUCt is the measure of the plasma drug concentration from time zero to time t.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8,10, 12, 24 and 48 hours Postdose on Day 1|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N (Number of participants analyzed) and n are number of participants analyzed for this outcome measure and for the specified compound, respectively."||h*ng/mL||Standard Deviation|Mean
658566|NCT01898884|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC[0-8]) of VP 20629 and Its Metabolite (VP 20631) for Single Dose Groups|The AUC(0-8) is the area under the plasma concentration-time curve from time zero to 8 hours postdose.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, and 8 hours Postdose on Day 1|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N (Number of participants analyzed) and n are number of participants analyzed for this outcome measure and for the specified compound, respectively."||h*ng/mL||Standard Deviation|Mean
658567|NCT01898884|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC) of VP 20629 and Its Metabolite (VP 20631) for Single Dose Groups|The AUC is the area under the plasma concentration-time curve observed.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8,10, 12, 24 and 48 hours Postdose on Day 1|The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations.||hour*nanogram per milliliter (h*ng/mL)||Standard Deviation|Mean
658568|NCT01898884|Secondary|Time of Maximum Observed Plasma Concentration (Tmax) of VP 20629 and Its Metabolite (VP 20631) for Single Dose Groups|The Tmax is the time to reach maximum observed plasma concentration of single dose of VP 20629 and VP 20631.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8,10, 12, 24 and 48 hours Postdose on Day 1|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N (Number of participants analyzed) and n are number of participants analyzed for this outcome measure and for the specified compound, respectively."||hour||Standard Deviation|Mean
658569|NCT01898884|Secondary|Maximum Observed Serum Concentration (Cmax) of VP 20629 and Its Metabolite (VP 20631) for Single Dose Groups|The Cmax is the maximum observed plasma concentration of single dose of VP 20629 and VP 20631.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8,10, 12, 24 and 48 hours Postdose on Day 1|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N (Number of participants analyzed) and n are number of participants analyzed for this outcome measure and for the specified compound, respectively."||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
658570|NCT01898884|Primary|Number of Participants With Clinically Relevant Electrocardiogram (ECG) Abnormalities Recorded as Adverse Events (AEs)|ECG included PR interval, QRS interval, QTcB interval, QTcF interval were considered as clinically significant ECG abnormalities.|From Start of Study Treatment up to Day 19|The ITT-S set consisted of all participants who were randomly assigned to an investigational product treatment group and who received at least 1 partial or complete dose of investigational product.||participants|||Number
658571|NCT01898884|Primary|Number of Participants With Vital Signs Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)|Vital sign assessments included systolic blood pressure, diastolic blood pressure, heart rate, and temperature. Vital signs abnormalities reported as TEAEs were reported.|From Start of Study Treatment up to Day 19|The ITT-S set consisted of all participants who were randomly assigned to an investigational product treatment group and who received at least 1 partial or complete dose of investigational product.||participants|||Number
658572|NCT01898884|Primary|Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)|An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Treatment-emergent were events between first dose of study drug and 7 days after the last dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with Grade 3 or higher treatment-emergent adverse events for laboratory abnormalities were reported as clinically relevant laboratory changes.|From Start of Study Treatment up to Day 19|The ITT-S set consisted of all participants who were randomly assigned to an investigational product treatment group and who received at least 1 partial or complete dose of investigational product.||participants|||Number
658573|NCT01898884|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs (TEAEs), defined as all AEs that start during study drug treatment (and up to 7 days after the last dose of the study drug) and were not seen at baseline, or were seen at baseline but increased in frequency and/or severity during study drug treatment (and up to 7 days after the last dose of study drug).|From Start of Study Treatment up to Day 19|The ITT-safety (ITT-S) set consisted of all participants who were randomly assigned to an investigational product treatment group and who received at least 1 partial or complete dose of investigational product.||participants|||Number
658574|NCT01898598|Secondary|Percentage of Participants With BCC Recurrence||Baseline, 12, 24, and 52 weeks post MMS Visit (MMS Visit = Week 12-14)|This outcome was based on the cumulative data post MMS Visit and due to early study termination with very few enrolled participants, complete data for this outcome measure could not be collected.|||||
658575|NCT01898598|Secondary|Percentage of Participants With Skip Area|Skip area was defined as the presence of non-contiguous residual tumor at the MMS visit, as determined by an independent dermatopathologist. MMS visit occurred within 2 weeks of the last study treatment.|MMS visit (Week 12-14)|ITT population.||Percentage of participants||95% Confidence Interval|Number
658576|NCT01898598|Secondary|Percentage of Participants With Clinical Response|Clinical response was defined as a complete response (CR) or partial response (PR) at the post-treatment MMS excision. CR was defined as no histological evidence of BCC. PR was defined as a reduction of at least 50 % in the expected surgical defect area with histologic evidence of residual BCC. MMS visit was defined the visit that occurred within 2 weeks of the last study treatment.|MMS visit (Week 12-14)|ITT population.||Percentage of participants||95% Confidence Interval|Number
658612|NCT01897792|Secondary|Number of Protocol Violations Per Arm.|The number of times that there was a deviation or violation from how the protocol was to be implemented.|from enrollment up to 60 days post enrollment|||protocol deviations|||Number
658613|NCT01897792|Primary|Number of Total Blood Product Transfusions|the number of blood product transfusions for all subjects in each group over the course of 3 days.|From enrollment to 3 days|||blood transfusions|||Number
658614|NCT01897792|Primary|Number of Subjects With Organ Injury|Any injury to internal organs (thoracic, abdominal or cranial cavity)|From enrollment to 3 days|||participants|||Number
658577|NCT01898598|Secondary|Percentage Change in Target BCC Actual Tumor-Free Margin Excision Area at MMS Visit|Percent change in target BCC actual tumor-free margin excision area was defined as = (expected surgical defect area pre-treatment - actual tumor-free margin excision area at MMS visit) / expected surgical defect area pre-treatment) * 100%. The actual tumor-free margin excision area (includes 2 millimeters [mm] margin) was measured during MMS. The area was photographed and traced on the digital photograph then calculated by computer-aided planimetry. MMS visit was defined as the visit that occurred within 2 weeks of the last study treatment.|Baseline, MMS visit (Week 12-14)|ITT. Here 'Number of participants analyzed' represents participants evaluable for this outcome measure.||Percent change in margin excision area||Standard Deviation|Mean
658578|NCT01898598|Secondary|Actual Change in Target BCC Expected Surgical Defect Area at MMS Visit|Actual change was defined as (baseline expected surgical defect area - expected surgical defect area at MMS visit). MMS visit was defined as the visit that occurred within 2 weeks of the last study treatment. Expected surgical defect area was manually outlined on a digital photograph and measured by a computer (computer aided planimetry).|Baseline, MSS Visit (Week 12-14)|ITT Population. Here 'Number of participants analyzed' represents participants evaluable for this outcome measure.||Square millimeter (mm^2)||Standard Deviation|Mean
658579|NCT01898598|Primary|Percent Change in Target Basal Cell Carcinoma (BCC) Expected Surgical Defect Area at Mohs Micrographic Surgery (MMS) Visit|The percent change in target BCC expected surgical defect area was defined as ([baseline expected surgical defect area − expected surgical defect area at MMS visit]/ baseline expected surgical defect area) × 100 percent (%) where expected surgical defect area was manually outlined on a digital photograph and measured by a computer (computer aided planimetry). MMS visit was defined as the visit that occurred within 2 weeks of the last study treatment.|Baseline, MMS visit (Week 12-14)|ITT population. Here 'Number of participants analyzed' represents participants evaluable for this outcome measure.||Percent change in surgical defect area||Standard Deviation|Mean
658580|NCT01898442|Secondary|Pharmacokinetic Profiles of Ticagrelor (AUC0-t)|Pharmacokinetic assessments included determination of plasma concentration of ticagrelor. Time for the maximum plasma concentration (Tmax), maximum observed plasma concentration (Cmax) and the area under the plasma concentration vs. time curve from time 0 to the last measurable concentration (AUC0-t) were calculated.|24 hours|||ng*hr/mL||Full Range|Geometric Mean
658581|NCT01898442|Secondary|Pharmacokinetic Profiles of Ticagrelor (Cmax)|Pharmacokinetic assessments included determination of plasma concentration of ticagrelor. Time for the maximum plasma concentration (Tmax), maximum observed plasma concentration (Cmax) and the area under the plasma concentration vs. time curve from time 0 to the last measurable concentration (AUC0-t) were calculated.|24 hours|||ng/mL||Full Range|Geometric Mean
658582|NCT01898442|Secondary|Pharmacokinetic Profiles of Ticagrelor (Tmax)|Pharmacokinetic assessments included determination of plasma concentration of ticagrelor. Time for the maximum plasma concentration (Tmax), maximum observed plasma concentration (Cmax) and the area under the plasma concentration vs. time curve from time 0 to the last measurable concentration (AUC0-t) were calculated.|24 hours|||hours||Full Range|Geometric Mean
658583|NCT01898442|Secondary|Platelet Reactivity by Vasodilator-stimulated Phosphoprotein (VASP) at All Time Points|Secondary outcomes included the comparison of the platelet reactivity index (PRI) determined by vasodilator-stimulated phosphoprotein (VASP) at 30 min and 1, 2, 4, 8, 24 hours after ticagrelor loading dose administration|30 min and 1, 2, 4, 8, 24 hours|||PRI||Standard Error|Least Squares Mean
658584|NCT01898442|Secondary|Platelet Reactivity by VerifyNow P2Y12 at Other Time Points|Secondary outcomes included the comparison of the P2Y12 reaction units (PRU) determined by VerifyNow P2Y12 at 30 min and 2, 4, 8, 24 hours after ticagrelor loading dose administration|30 min and 2, 4, 8, 24 hours|||PRU||Standard Error|Least Squares Mean
658585|NCT01898442|Primary|Platelet Reactivity by VerifyNow P2Y12|The primary end-point of the study was the comparison of the P2Y12 reaction units (PRU) determined by VerifyNow P2Y12 at 1 hour after administration|1 hour|||PRU||Standard Error|Least Squares Mean
658586|NCT01898403|Primary|Sentinel Lymph Nodes (SLN) Mapping|Sentinel lymph nodes (SLN) will be identified and mapped using indocyanine green (ICG) solution, isosulfan blue (ISB) solution, and TSC lymphoscintigraphy.|Up to 1 year|All participants were evaluated for sentinel lymph nodes (SLN) using Isosulfan Blue (ISB); Indocyanine Green (ICG); and TSC lymphoscintigraphy.||Sentinel lymph nodes|Sentinel Lymph Nodes||Number
658587|NCT01898286|Other Pre-specified|Glycemic Control (Change From Baseline in % HbA1c)||Baseline and Early Termination Visit, Up to 25 Months|All patients with % HbA1c data at baseline and their early termination visit. Only 5 patients were available for this analysis, as not all patients agreed to complete HbA1c testing at the early termination visit.||% HbA1c||Standard Deviation|Mean
658588|NCT01898286|Other Pre-specified|Change From Baseline in Daily Insulin Dose, Per kg Body Weight, at Early Termination Visit||Baseline and Early Termination Visit, up to 25 months|All patients with daily insulin dose data at baseline and their early termination visit. Only 11 patients could be included in this analysis, as not all patients provided insulin dose data at their early termination visit.||IU/kg||Standard Deviation|Mean
658589|NCT01898286|Secondary|Change From Baseline in Glucagon-stimulated C-peptide AUC at Early Termination Visit|Beta-cell function, measured as change in stimulated C-peptide secretion measured 0, 2, 6, 10 and 20 minutes post administration [area under the curve (AUC), 0-20 minutes] at Baseline and the early termination visit (up to 25 months), during a glucagon stimulation test (GST). Change was calculated for each patient by subtracting the baseline AUC value (defined as the last non-missing assessment prior to first dose in the 1010 study but after the end of study 1001) from the early termination visit AUC.|Baseline and Early Termination Visit, Up to 25 Months|Only 9 patients had sufficient data for this analysis, as many patients declined to undergo the GST at the termination visit.||nmol*minute/L||Standard Deviation|Mean
658590|NCT01898286|Primary|Hypoglycemic Events|The number of hypoglycemic events recorded by each patient over the course of the study.|At Early Termination Visit, Up to 25 Months|Patients with hypoglycemic event data at the time of their early termination visit. This population is smaller than the population numbers in the patient flow categories because not all patients were willing to provide information on hypoglycemic events at early termination.||hypoglycemic events||Standard Deviation|Mean
658615|NCT01897792|Primary|Number of Subjects With Ventilator-associated Pneumonia.|Number of subjects diagnosed with pneumonia and requiring ventilator support.|From enrollment to 3 days|||participants|||Number
658591|NCT01898208|Secondary|Mean Total Hospitalization, Laboratory Test, and Antimicrobials Costs Per Subject|Costs were calculated using a standardized inflation-adjusted estimate of costs for each service or procedure performed in constant dollars. This approach adjusts for hospital-billed charges with Medicare Cost Report department-level cost-to-charge ratios. Physician services were proxied with Medicare reimbursement rates based on Current Procedure Terminology (CPT)-4 codes using the Medicare Fee Schedule. We did not include the cost of the stewardship program in the cost analysis, as it is not a billed service. As there was no Medicare reimbursement rate for the rmPCR test at the time of the study, test cost was proxied using the FilmArray respiratory panel. These costs were varied in sensitivity analysis with rmPCR test cost ranging from a 50% decrease to a 300% increase.|Approximately 7 days after positive blood culture and for duration of entire hospitalization|The number of subjects analyzed per arm is different than the number of subjects who completed the study because outpatients and a few subjects without final billing data available were excluded.||dollars||Standard Deviation|Mean
658592|NCT01898208|Secondary|Percentage of Subjects With Infectious Disease Consultation Within 72 Hours of Enrollment||Approximately within 72 hours of positive blood culture|||percentage of participants|||Number
658593|NCT01898208|Secondary|Number of Subjects With Antibiotic-Associated Toxicities/Adverse Events|This included all adverse events that occurred within 2 weeks following enrollment and were documented in the medical record.|Approximately 14 days after positive blood culture|||participants|||Number
658594|NCT01898208|Secondary|All-cause and Attributable Mortality|If records of death were incomplete, mortality was determined using Accurint (LexisNexis, Philadelphia, PA), an internet research and location service.|30 days after positive blood culture|||participants|||Number
658595|NCT01898208|Secondary|Length of Entire Hospitalization (Days)||Participants were followed for the duration of hospital stay, approximately 15 days|||days||Inter-Quartile Range|Median
658596|NCT01898208|Other Pre-specified|Percentage of Patients Who Acquired Clostridium Difficile or Multidrug-resistant Organisms Within 30 Days After Enrollment|Multidrug-resistant organisms included vancomycin-resistant enterococci, methicillin-resistant Staphylococcus aureus, extended-spectrum cephalosporin-resistant Enterobacteriaceae, and Pseudomonas aeruginosa and Acinetobacter species resistant to greater than or equal to 3 antibiotic classes.|Approximately 30 days after positive blood culture|||percentage of participants|||Number
658597|NCT01898208|Other Pre-specified|Length of Intensive Care Unit Stay||within 14 days of positive blood culture until ICU discharge|||days||Inter-Quartile Range|Median
658598|NCT01898208|Secondary|Number of Subjects Who Had Negative Blood Cultures Within 3 Days After Enrollment||3 Days after enrollment|||participants|||Number
658599|NCT01898208|Secondary|Time to Pathogen Identification||Approximately 14 days after positive blood culture|The number of subjects analyzed per arm differs from the number of subjects who completed the study because this outcome measure includes only the subset of subjects who had organisms represented on the rapid multiplex PCR (rmPCR) panel.||hours||Inter-Quartile Range|Median
658600|NCT01898208|Secondary|Percent of Contaminated Blood Cultures Not Treated or Treated for Less Than 24 Hours|Contaminated blood cultures were defined as growth of organisms such as coagulase-negative staphylococci from a single blood culture set when greater than or equal to 2 blood culture sets were collected, except among subjects suspected to have true bacteremia associated with central venous catheters or devices.|Within 14 days after positive blood culture|||Percentage of blood cultures|||Number
658601|NCT01898208|Secondary|Time to First Appropriate De-escalation or First Appropriate Escalation of Antibiotics|De-escalation included discontinuation of 1 or more antibiotics and/or switching from a broad- to a narrow spectrum antibiotic. Escalation included initiation of 1 or more antibiotics and/or switching from a narrow- to a broad-spectrum antibiotic.|Positive Gram stain, 96 hours after enrollment|Not all subjects experienced de-escalation or escalation of their antibiotics. Participants analyzed per variable below are expressed as (n=control, FilmArray test, and FilmArray+Stewardship).||hours||Inter-Quartile Range|Median
658602|NCT01898208|Secondary|Time From Positive Gram Stain to First Active Antibiotic|From positive Gram stain to start of active antibiotic among patients not on active therapy at enrollment; excludes subjects with contaminated blood cultures.|Approximately 14 days after positive blood culture|Not all subjects were not on active therapy at enrollment, and also subjects with contaminated blood cultures were excluded. Participants analyzed per variable below are expressed as (n=control, FilmArray test, and FilmArray+Stewardship): (n=45, 41, 37)||hours||Inter-Quartile Range|Median
658603|NCT01898208|Primary|Duration of Antimicrobial Therapy (Hours)|Difference between the date and time of the antibiotic start order (or Gram stain-positive blood culture, if antibiotics were started prior to the positive culture result) and the date and time of the antibiotic stop order. Shorter duration of broad spectrum antibiotics and longer duration of narrow-spectrum antibiotics were considered favorable outcomes.|Approximately 4 days after enrollment|Subjects could have received more than one antimicrobial. Participants analyzed per variable below are expressed as (n=control, FilmArray test, and FilmArray+Stewardship)||hours||Inter-Quartile Range|Median
658604|NCT01898195|Secondary|End-of-intervention Smoking Abstinence|number of participants who achieved smoking abstinence based on self-reported 7-day point prevalence smoking abstinence verified by a carbon monoxide (CO) < 8 ppm|7 Days|||participants|||Number
658605|NCT01898195|Primary|End-of-intervention Varenicline Adherence|number of participants who took at least 80% prescribed dose since last interview, based on pill count|4 Weeks|||participants|||Number
658606|NCT01898091|Primary|Maximum Change in Mean Mouth and Throat Soreness (MTS) Score From Baseline Through Weeks of Radiation Therapy Using the MTS Question of the Modified Oral Mucositis Daily Questionnaire*.|Severity is assessed as the maximum change in mean mouth and throat soreness (MTS) score from baseline during the weeks of RT, using MTS question of the validated Oral Mucositis Daily Questionnaire (modified OMDQ): “During the past 24 hours, how much mouth and throat soreness did you have?” The MTS score is a 5-point score, ranging from 0=No soreness to 4=Extreme soreness. We compared the maximum change in MTS score between the two groups using the Wilcoxon rank sum test with a one-sided alpha of 0.05.|MTS score is collected at the baseline visit and once each week during the 7 weeks of radiation therapy.|Exclusion criterion was those with a baseline mouth and throat soreness (MTS) extreme score of 4.||units on a scale||Standard Deviation|Mean
658607|NCT01897792|Secondary|Mean Number of Hospital Stay Days.|The mean number of days subjects were in the hospital in each arm of the study|from enrollment up to 60 days post enrollment|||days||Full Range|Mean
658616|NCT01897792|Primary|Number of Participants With Coagulation Abnormalities|Coagulation parameters are evaluated using standard functional tests (prothrombin time (PT), partial thromboplastin time (PTT), fibrinogen and platelet count)and point of care functional analysis using thromboelastogram (TEG-ROTEM). A blood sample is collected upon arrival in the emergency department at 0 hours only and analyzed for markers of activation of coagulation, inflammation, and levels of vitamin C/E.|From enrollment up to 3 days|||participants|||Number
658617|NCT01897727|Primary|Severity of Obstructive Sleep Apnea|3 month change in apnea-hypopnea index assessed by diagnostic, full-night polysomnography. AHI values are typically categorized as 5-15/hr = mild; 15-30/hr = moderate; and > 30/h = severe.|baseline and 3 months|||events/hour||Standard Deviation|Mean
658618|NCT01897402|Secondary|Non Solicited Adverse Events|Non solicited local and systemic adverse Event (AE) rates throughout the course of the study, based on laboratory test results, vital signs, examination and questioning the subjects.|up to 6 months|Safety Population: All vaccinated participants, grouped by actual vaccine received.||participants|||Number
658619|NCT01897402|Secondary|Solicited Adverse Events From Diary Cards|Local and systemic rates from Diary Cards filled by the participants.|Day 0 to Day 7 after vaccination|Safety Population: All vaccinated participants, grouped by actual vaccine received.||percentage of participants|||Number
658620|NCT01897402|Primary|Seroresponse (Percent Seroconversion).|Rise in antibody titers in serum at 4 weeks after vaccination, compared to baseline titer for meningococcal serogroups A, C, Y, and W-135. Serum Bactericidal Assay with human complement: Antibody titer ≥1:8 for subjects with titer <1:8 at baseline or a 4-fold rise in antibody levels.|Week 4 after injection|Per Protocol Population||percentage of per protocol participants||95% Confidence Interval|Number
658621|NCT01897285|Secondary|Safety - the Nature and Frequency of Adverse Events|"Safety will be determined by the nature and frequency of Adverse Events. Condition of the skin under and around the dressings along with the incidence of skin irritation will be assessed. The incidence and nature of all adverse events will be recorded.
Condition of the skin was evaluated by the Skin Irritation Scale. The possible responses are doubtful reaction, weak positive reaction, strong positive reaction, extreme positive reaction, irritant reaction, and negative reaction."|7 days|||participants|||Number
658622|NCT01897285|Primary|Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin)|"Adhesion at 7 days measured by:
1 = Excellent 2 = Good 3 = Average 4 = Poor 5 = Very Poor
Conformability
1 = Excellent 2 = Good 3 = Average 4 = Poor 5 = Very Poor
Dressing Integrity
1 = Excellent 2 = Good 3 = Average 4 = Poor 5 = Very Poor
Ease of Application
1 = Excellent 2 = Good 3 = Average 4 = Poor 5 = Very Poor
Ease of Removal,
1 = Very easy 2 = Easy 3 = Difficult 4 = Very difficult
Adhesive Residue 0 = None 1 = Minimal 2 = Moderate 3 = Considerable
Comfort during removal
1 = Excellent 2 = Good 3 = Average 4 = Poor 5 = Very Poor
Condition of the skin This will be evaluated by the Skin Irritation Scale (Doubtful reaction/weak positive reaction/ strong positive reaction/ extreme positive reaction/irritant reaction/ negative reaction)"|7 days|20/20 subjects completed maximum study participation of 7 days. Two subjects dressings detached very early on so returned for their final evaluation on the second day. The final subject status was recorded as ‘other’ for these two subjects. Many dressings detached when volunteers were away from the clinic and prior to returning for the assessments.||participants|||Number
658623|NCT01897233|Secondary|Part B: Pre-dose Concentration (Ctrough) and 3 to 6 Hours Post-dose Concentration (C3-6hr) of Lumacaftor, Lumacaftor Metabolite (M28-LUM), Ivacaftor and Ivacaftor Metabolites (M1-IVA and M6-IVA)|Ctrough and C3-6hr for lumacaftor, M28 lumacaftor (lumacaftor metabolite), ivacaftor, M1 ivacaftor (ivacaftor metabolite), and M6 ivacaftor (ivacaftor metabolite) were calculated. Ctrough was observed pre-dose concentration. C3-6hr was observed concentration at 3 to 6 hours post- dose.|For Ctrough: pre-morning dose on Week 4, Week 6 and Week 24; For C3-6hr: 3 to 6 hours post-morning dose on Day 1, 15 and Week 4|The PK Set included all enrolled participants who received the study drug and for whom the primary PK data were considered to be sufficient and interpretable. Here “n” signifies those participants who were evaluable at the specified time point for the given category.||ng/mL||Standard Deviation|Mean
658624|NCT01897233|Secondary|Part B: Absolute Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Domains at Week 24|The TSQM is a 14-item self-administered questionnaire which measures participants’ experiences with their medication on four dimensions: effectiveness, side effects, convenience and global satisfaction. For each dimension, responses are added and transformed to a scale from 0 to 100, where higher scores indicate greater satisfaction.|Baseline, Week 24|The FAS included all Part B enrolled participants who were exposed to any amount of Part B study drug. Here “Number of Participants” analyzed signifies those participants who were evaluable for this outcome measure.||units on a scale||95% Confidence Interval|Least Squares Mean
658625|NCT01897233|Secondary|Part B: Absolute Change From Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score at Week 24|The CFQ-R is a validated patient-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.|Baseline, Week 24|The FAS included all Part B enrolled participants who were exposed to any amount of Part B study drug. Here “Number of Participants” analyzed signifies those participants who were evaluable for this outcome measure.||Units on a scale||95% Confidence Interval|Least Squares Mean
658626|NCT01897233|Secondary|Part B: Absolute Change From Baseline in Height-for-age Z-score at Week 24|Z-score is a statistical measure to evaluate how a single data point compares to a standard. It describes whether a mean was above or below the standard and how unusual the measurement is, with range from -infinity to +infinity; where 0: same mean, >0: a greater mean, and <0: a lesser mean than the standard. Height, adjusted for age and sex, was analyzed as height-for-age z-score (height z-score). The height-for-age z-scores were calculated using National Center for Health Statistics growth charts.|Baseline, Week 24|The FAS included all Part B enrolled participants who were exposed to any amount of Part B study drug. Here “Number of Participants” analyzed signifies those participants who were evaluable for this outcome measure.||z-score||95% Confidence Interval|Least Squares Mean
658627|NCT01897233|Secondary|Part B: Absolute Change From Baseline in Height at Week 24||Baseline, Week 24|The FAS included all Part B enrolled participants who were exposed to any amount of Part B study drug. Here “Number of Participants” analyzed signifies those participants who were evaluable for this outcome measure.||centimeter (cm)||95% Confidence Interval|Least Squares Mean
658628|NCT01897233|Secondary|Part B: Absolute Change From Baseline in Weight-for-age Z-score at Week 24|Z-score is a statistical measure to evaluate how a single data point compares to a standard. It describes whether a mean was above or below the standard and how unusual the measurement is, with range from -infinity to +infinity; where 0: same mean, >0: a greater mean, and <0: a lesser mean than the standard. Weight, adjusted for age and sex, was analyzed as weight-for-age z-score (weight z-score). The weight-for-age z-scores were calculated using National Center for Health Statistics growth charts.|Baseline, Week 24|The FAS included all Part B enrolled participants who were exposed to any amount of Part B study drug. Here “Number of Participants” analyzed signifies those participants who were evaluable for this outcome measure.||z-score||95% Confidence Interval|Least Squares Mean
658629|NCT01897233|Secondary|Part B: Absolute Change From Baseline in Weight at Week 24||Baseline, Week 24|The FAS included all Part B enrolled participants who were exposed to any amount of Part B study drug. Here “Number of Participants” analyzed signifies those participants who were evaluable for this outcome measure.||kilograms (kg)||95% Confidence Interval|Least Squares Mean
658630|NCT01897233|Secondary|Part B: Absolute Change From Baseline in BMI-for-age Z-score at Week 24|BMI was defined as weight in kg divided by height*height in m^2. z-score is a statistical measure to evaluate how a single data point compares to a standard. It describes whether a mean was above or below the standard and how unusual the measurement is, with range from -infinity to +infinity; where 0: same mean, >0: a greater mean, and <0: a lesser mean than the standard. BMI, adjusted for age and sex, was analyzed as BMI-for-age z-score (BMI z-score). The BMI-for-age z-scores were calculated using National Center for Health Statistics growth charts.|Baseline, Week 24|The FAS included all Part B enrolled participants who were exposed to any amount of Part B study drug. Here “Number of Participants” analyzed signifies those participants who were evaluable for this outcome measure.||z-score||95% Confidence Interval|Least Squares Mean
658631|NCT01897233|Secondary|Part B: Absolute Change From Baseline in Body Mass Index (BMI) at Week 24|BMI was defined as weight in kilogram (kg) divided by height*height in square meter (m^2).|Baseline, Week 24|The FAS included all Part B enrolled participants who were exposed to any amount of Part B study drug. Here “Number of Participants” analyzed signifies those participants who were evaluable for this outcome measure.||kilogram per square meter (kg/m^2)||95% Confidence Interval|Least Squares Mean
658632|NCT01897233|Secondary|Part B: Absolute Change in Sweat Chloride From Week 24 at Week 26|Sweat samples were collected using an approved collection device. Change = Week 26 minus Week 24.|Week 24, Week 26|The FAS included all Part B enrolled participants who were exposed to any amount of Part B study drug. Here “Number of Participants” analyzed signifies those participants who were evaluable for this outcome measure.||mmol/L||95% Confidence Interval|Least Squares Mean
658633|NCT01897233|Secondary|Part B: Average Absolute Change From Baseline in Sweat Chloride at Day 15 and at Week 4|Sweat samples were collected using an approved collection device. Baseline was defined as the average of the measurements at screening and on Day 1 pre-dose. Average of Day 15 and Week 4 measurements was taken and change was calculated as: Average (Day 15 and Week 4 measurement) minus Baseline measurement.|Baseline, Day 15 and Week 4|The Full Analysis Set (FAS) included all Part B enrolled participants who were exposed to any amount of Part B study drug. Here “Number of Participants” analyzed signifies those participants who were evaluable for this outcome measure.||millimole per liter (mmol/L)||95% Confidence Interval|Least Squares Mean
658634|NCT01897233|Secondary|Part A: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. AE includes serious as well as non-serious AEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, inpatient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. AEs with start date or increased severity on or after the first study drug dose through the end of Part A were considered treatment-emergent.|Day 1 up to Day 28|The Safety Set included all participants who received at least 1 dose of study drug. Here “n” signifies those subjects who were evaluable for the specified cohort.||participants|||Number
658635|NCT01897233|Secondary|Part A: Observed Plasma Concentration of Lumacaftor Metabolite (M28-LUM) and Ivacaftor Metabolites (M1-IVA and M6-IVA) at Hour 4 Post-dose (C4h) on Day 1 and 14||Day 1, Day 14|The PK Set included all enrolled participants who received the study drug and for whom the primary PK data were considered to be sufficient and interpretable.||ng/mL||Standard Deviation|Mean
658636|NCT01897233|Primary|Part B: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. AE includes serious as well as non-serious AEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, inpatient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. AEs with start date or increased severity on or after the first study drug dose to Week 26 were considered treatment-emergent.|Day 1 up to Week 26|The Safety Set included all participants who received any amount of Part B study drug||participants|||Number
658637|NCT01897233|Primary|Part A: Area Under the Plasma Concentration-Time Curve From Time 0 to End of Dosing Interval (AUCtau) of Lumacaftor (LUM) and Ivacaftor (IVA)|The AUCtau is the area under the concentration versus time curve from time 0 to time tau, where tau is the time at the end of dosing interval.|Day 14 (pre-morning dose, 4, 6, 12, and 24 hours post-morning dose for LUM; pre-morning dose, 2, 4, 6, 12 hours post-morning dose for IVA)|The PK Set included all enrolled participants who received the study drug and for whom the primary PK data were considered to be sufficient and interpretable.||ng*hr/mL||Full Range|Median
658638|NCT01897233|Primary|Part A: Observed Plasma Concentration of Lumacaftor (LUM) and Ivacaftor (IVA) at Hour 4 Post-dose (C4h) on Day 14||4 hours post-morning dose on Day 14|The PK Set included all enrolled participants who received the study drug and for whom the primary PK data were considered to be sufficient and interpretable.||ng/mL||Standard Deviation|Mean
658643|NCT01897025|Secondary|Resting Motor Threshold of Stroke Affected M1 Motor Cortex|"Resting motor threshold (RMT) is defined as the percentage of maximum stimulator output required to elicit motor evoked potential (MEP) with 50 µV peak-to-peak amplitude in at least 4 out of 8 trials during single-pulse transcranial magnetic stimulation (TMS).
Short intra-cortical inhibition (SICI) and intracortical facilitation (ICF) were measured using paired pulse stimulation with an initial conditioning stimulus of 80% of RMT and a test stimulus of 120% of RMT. MEPs were recorded at inter-stimulus intervals (ISIs) of 2, 4, 6, 10 and 15 ms. ISIs of 1-3 ms typically induce SICI while ISIs of 10-15ms typically reflect ICF.
This part of data is still under analyzing."|pre- and post-training, 4 weeks post-training||12/2015||||
658644|NCT01897025|Primary|Upper Extremity Component of Fugl-Meyer Assessment|The total FMA score (range, 0-66) on the stroke-impaired upper extremity was used to measure the motor improvements in this study. Higher score indicates better upper limb motor function. FMA were measured at 3 time points: at baseline (wk 0), at completion of intervention (wk 2), and at a 2-week follow-up (wk 4).|week 0, week 2, week 4|Subjects aged 21 to 70 years who had their first-ever subcortical stroke at least 9 months before recruitment, with moderate to severe impairment of upper extremity function (subscore of the Fugl-Meyer Motor Assessment [FMMA], 11-45), were recruited.||units on a scale||Standard Deviation|Mean
658645|NCT01896986|Primary|Immunogenicity to HPV Vaccine Gardasil|To evaluate the long term immunogenicity of the quadrivalent 4/6/11/18 HPV vaccine Gardasil® by following up a cohort of adolescent females aged 16-30 years with PRD or IBD, 5 years post HPV vaccination at the Royal Children’s Hospital (RCH) Melbourne .|12 months|No immunogenicity data collected as samples were lost.|||||
658646|NCT01896934|Secondary|Change in Patient-rated Depression Severity|Change in depression severity measured by the patient-rated Quick Inventory of Depressive Symptoms, Self-Rated (QIDS-SR16). The QIDS-SR16 is a self-report measure of depression severity with a range of 0-27, with higher scores indicative of more severe depression.|Assessed every 2 weeks from baseline to week 12, change from baseline to week 12 is reported|||units on a scale||Standard Error|Mean
658647|NCT01896934|Secondary|Change in Clinician-rated Depression Severity|Change in depression severity will be measured by the clinician-rated Montgomery Asberg Depression Rating Scale (MADRS), range of 0-60, with higher scores indicating more severe depression|Assessed every 2 weeks from baseline to week 12, change from baseline to week 12 is reported|||units on a scale||Standard Deviation|Mean
658648|NCT01896934|Primary|Remission of Depression|Montgomery-Asberg Depression Rating Scale (MADRS) is a measure of depression severity. This will be used to define remission as a score of 7 or less.|Week 12|Individuals achieving remission of depression, defined as MADRS score of 7 or less.||Participants|||Count of Participants
658649|NCT01896726|Primary|PK: AUC(0-∞) of Levonorgestrel||Days 1 and 29: predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24 and 48 hours post dose|All enrolled participants who received study drug (Microgynon in Period 1 and at least 1 dose of baricitinib and Microgynon in Period 2) and had PK data to calculate AUC(0-∞) of levonorgestrel.||pg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
658650|NCT01896726|Primary|PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of Ethinyl Estradiol||Days 1 and 29: predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24 and 48 hours post dose|All enrolled participants who received study drug (Microgynon in Period 1 and at least 1 dose of baricitinib and Microgynon in Period 2) and had PK data to calculate AUC(0-∞) of ethinyl estradiol.||picograms*hour/milliliter (pg*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
658651|NCT01896726|Primary|PK: Cmax of Levonorgestrel||Days 1 and 29: predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24 and 48 hours post dose|All enrolled participants who received study drug (Microgynon in Period 1 and at least 1 dose of baricitinib and Microgynon in Period 2) and had PK data to calculate Cmax of levonorgestrel.||pg/mL||Geometric Coefficient of Variation|Geometric Mean
658652|NCT01896726|Primary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ethinyl Estradiol||Days 1 and 29: predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24 and 48 hours post dose|All enrolled participants who received study drug (Microgynon in Period 1 and at least 1 dose of baricitinib and Microgynon in Period 2) and had PK data to calculate Cmax of ethinyl estradiol.||picograms/milliliter (pg/mL)||Geometric Coefficient of Variation|Geometric Mean
658653|NCT01896687|Primary|Worst Low Back Pain Score|"Low back pain will be measured by the Brief Pain Inventory (BPI). The BPI assesses the severity of pain, location of pain, pain medications, amount of pain relief in the past 24 hours and the past week, and the impact of pain on daily functions. For this study, the worst pain score will be used in the analysis. The worst pain score is rated from 0 meaning no pain to 10 meaning pain as bad as you can imagine."|baseline to 3 weeks post-treatment|||units on a scale||Standard Deviation|Mean
658654|NCT01896557|Other Pre-specified|Comparing the Main Outcome on Pre-specified Subgroups|"The main outcome will be compared on pre-specified subgroups:
elderly (age > 65 yrs-old) versus non-elderly
male versus female
smoking versus non-smoking patients
obese (BMI > 30 kg/m2) versus non-obese
diabetic versus non-diabetic
patients in use or not in use of statins
presence or not of genetic polymorphisms on cytochrome 2C19."|1 week after drug exposure||||||
658655|NCT01896557|Secondary|Comparison of the Primary Outcome With Other Two Methods of Platelet Aggregability: PFA-100 and Bioimpedance Aggregometry|After 1 week of randomization to ranitidin or omeprazole, the platelet function will also be analysed by two other methods: PFA-100 (Siemens-USA) and bioimpedance aggregometry.|1 week after drug exposure||||||
658656|NCT01896557|Primary|Comparing Platelet Function of Patients on Dual Antiplatelet Therapy With ASA + Clopidogrel, Between the Groups Ranitidin and Omeprazole, Using VerifyNow Method.|One week after starting double-blind, double-dummy, randomized therapy with ranitidin or omeprazole on patients treated with DAPT, platelet function will be compared with the method VerifyNow, in percent Inhibition of Platelet Aggregation (IPA) from baseline. IPA was calculated as Observed Platelet aggregability - Platelet aggregability at baseline divided by Platelet aggregability at baseline.|One week after drug exposure (omeprazole/ranitidine); 2 weeks after baseline|||Inhibition of Platelet Aggregation||Standard Deviation|Mean
658657|NCT01896557|Primary|Comparing Platelet Function of Patients on Dual Antiplatelet Therapy With ASA + Clopidogrel, Between the Groups Ranitidin and Omeprazole, Using VerifyNow Method.|One week after starting double-blind, double-dummy, randomized therapy with ranitidin or omeprazole on patients treated with DAPT, platelet function will be compared with the method VerifyNow, in P2Y12 Reactivity Units.|One week after drug exposure (omeprazole/ranitidine); 2 weeks after baseline|||P2Y12 Reactivity Units||Standard Deviation|Mean
658658|NCT01896544|Secondary|Change in Immunological Profile 5 Days Following Supplementation With Cholecalciferol|Subjects will receive 200,000 IU or 400,000 IU cholecalciferol suspension (vs. placebo) within 24 hours from the onset of a suspected case of sepsis during their hospitalization. Immunological profile at the onset of a suspected case of sepsis will be compared to the immunological profile between 5-9 days after supplementation with cholecalciferol or placebo. To assess the immunological profile, we will measure serum hsCRP.|Patients will be followed between the onset of suspected sepsis and for an average duration of 90 days|||mg/L||Inter-Quartile Range|Median
658659|NCT01896544|Secondary|Incidence of Infection-related Complications Within 90 Days From the Onset of a Suspected Case of Sepsis|"Subjects will receive 200,000 IU or 400,000 IU cholecalciferol suspension (vs. placebo) within 24 hours from the onset of a suspected case of sepsis during their hospitalization. The incidence of infection-related complications will be assessed between the onset of suspected sepsis and 80-100 days after supplementation with cholecalciferol or placebo. To assess the incidence of infection-related complications, we will measure rates of:
1) 30 day hospital readmission; and 2) 30 day mortality."|Patients will be followed between the onset of suspected sepsis and for an average duration of 90 days|||participants|||Number
658660|NCT01896544|Secondary|Incidence of Infection-related Complications Within 90 Days From the Onset of a Suspected Case of Sepsis|Subjects will receive 200,000 IU or 400,000 IU cholecalciferol suspension (vs. placebo) within 24 hours from the onset of a suspected case of sepsis during their hospitalization. The incidence of infection-related complications will be assessed between the onset of suspected sepsis and 80-100 days after supplementation with cholecalciferol or placebo. To assess the incidence of infection-related complications, we will measure rates of: 1) ICU length of stay; and 2) hospital length of stay|Patients will be followed between the onset of suspected sepsis and for an average duration of 90 days|||days||Inter-Quartile Range|Mean
658661|NCT01896544|Secondary|Change in Immunological Profile 5 Days Following Supplementation With Cholecalciferol|Subjects will receive 200,000 IU or 400,000 IU cholecalciferol suspension (vs. placebo) within 24 hours from the onset of a suspected case of sepsis during their hospitalization. Immunological profile at the onset of a suspected case of sepsis will be compared to the immunological profile between 5-9 days after supplementation with cholecalciferol or placebo. To assess the immunological profile, we will measure serum LL-37.|Patients will be followed between the onset of suspected sepsis and for an average duration of 7 days|||ng/mL||Inter-Quartile Range|Median
658662|NCT01896544|Primary|Change in Vitamin D Status 5 Days Following Supplementation With Cholecalciferol|Subjects will receive 200,000 IU or 400,000 IU cholecalciferol suspension (vs. placebo) within 24 hours from the onset of a suspected case of sepsis during their hospitalization. Vitamin D status at the onset of a suspected case of sepsis will be compared to vitamin D status between 5-9 days after supplementation with cholecalciferol or placebo. To assess vitamin D status, we will measure serum and urine: 1) 25-hydroxyvitamin D; 2) 1,25-dihydroxyvitamin D; 3) 24,25-dihydroxyvitamin D; 4) Fibroblast growth factor 23; 5) Vitamin D binding protein; 6) LL-37; 7) Parathyroid hormone; 8) Albumin; 9) Calcium; and 10) Phosphorus levels.|Patients will be followed between the onset of suspected sepsis and for an average duration of 7 days|||ng/mL||Inter-Quartile Range|Median
658663|NCT01896297|Primary|Concentration of Analyte in Plasma at Steady State at 2 Hours After Administration of the Last Dose|Concentration of analyte in plasma at steady state at 2 hours after administration of the last dose (C2,ss)|2 hours after the last drug administration, on day 8|PKS. Analysis includes patients with available data.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
658664|NCT01896297|Primary|Pre-dose Concentration of the Analyte in Plasma at Steady State Immediately Before Administration of the Next Dose|Pre-dose concentration of the analyte in plasma at steady state immediately before administration of the next dose (Cpre,ss) taken at approximately 12 hours after the last dose (trough).|Immediately before the last drug administration, on day 8|Pharmacokinetic (PK) set (PKS) which included all patients in the treated set with analyzable data in at least one observation for at least one primary endpoint without important protocol violations relevant to the evaluation of PK. Analysis includes patients with available data.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
658665|NCT01896232|Secondary|Mean Number of Episodes of Vomiting Per Week in the First 8 Weeks|"The number of vomiting episodes was assessed using the Nausea and Vomiting Symptom Assessment questionnaire which asks participants on a daily basis how many times they vomited in the past 24 hours. The number of episodes in a week is the sum of all reported daily episodes in the week.
For participants providing less than 7 days of responses to NVSA questions in any given week, data from that week did not contribute to the analysis."|First 8 weeks|Full analysis set with available data. For participants providing less than 7 days of responses to NVSA questions in any given week, data from that week did not contribute to the analysis.||vomiting episodes per week||Standard Error|Least Squares Mean
658666|NCT01896232|Secondary|Mean Severity of Nausea in the First 8 Weeks|Severity of nausea was assessed using the Nausea and Vomiting Symptom Assessment questionnaire which asked participants to rate the severity of nausea on a scale from 0 (no nausea) to 10 (as severe as can be imagined). For each participant, the mean severity of nausea was calculated by averaging all available daily severities (including zeroes) reported in the first 8 weeks.|First 8 weeks|Full analysis set with available data||units on a scale||Standard Error|Least Squares Mean
658667|NCT01896232|Secondary|Percentage of Participants With Mean Predialysis Serum Phosphorus ≤ 4.5 mg/dL During the Efficacy Assessment Phase||Efficacy assessment phase (weeks 20 - 27)|Full analysis set; participants with no phosphorus assessments during the EAP were considered non-responders.||percentage of participants|||Number
658668|NCT01896232|Secondary|Percent Change From Baseline in Mean Corrected Calcium During the Efficacy Assessment Phase||Baseline and the efficacy assessment phase (weeks 20 - 27)|Full analysis set with available data.||percent change||Standard Error|Mean
658669|NCT01896232|Secondary|Mean Number of Days of Vomiting or Nausea Per Week in the First 8 Weeks|Participants completed the Nausea/Vomiting Symptom Assessment (NVSA) questionnaire daily. This questionnaire asked participants to indicate the severity of nausea on a scale from 0 (no nausea) to 10 (as severe as can be imagined) and if they had vomited in the past 24 hours. A day of vomiting or nausea was defined as those where the severity of nausea score was > 0 or where the episodes of vomiting score was > 0.|First 8 weeks|Full analysis set with available data. For participants providing less than 7 days of responses to NVSA questions in any given week, data from that week did not contribute to the analysis.||days of vomiting or nausea per week||Standard Error|Least Squares Mean
658670|NCT01896232|Secondary|Percentage of Participants With > 30% Reduction From Baseline in Mean PTH During the Efficacy Assessment Phase||Baseline and the efficacy assessment phase (Week 20 to Week 27)|Full analysis set; participants were considered non-responders if they did not have PTH data during the EAP (ie, non-responder imputation).||percentage of participants|||Number
658671|NCT01896232|Secondary|Percentage of Participants With > 50% Reduction From Baseline in Mean PTH During the Efficacy Assessment Phase||Baseline and the efficacy assessment phase (Weeks 20 to 27, inclusive).|Full analysis set; participants were considered non-responders if they did not have PTH data during the EAP (ie, non-responder imputation).||percentage of participants|||Number
658672|NCT01896232|Primary|Percentage of Participants With > 30% Reduction From Baseline in Mean Parathyroid Hormone During the Efficacy Assessment Phase - Non-inferiority Analysis||Baseline and the efficacy assessment phase (EAP; defined as Weeks 20 to 27, inclusive).|Full analysis set participants with PTH data during the EAP||percentage of participants|||Number
658673|NCT01896206|Primary|The Absolute Difference in Mean Arterial Pressure Between the Arterial Catheter and the CNAP.|To avoid biasing the data, the absolute, not directional, difference was used. For example, if the reading from the CNAP device was 10 mmHg above or below the reading from the AC, a value of 10 mmHg was used, not -10 or +10 mmHg.|Participants will be followed for the duration of surgery, an expected average of 2 hours.|The initial study cohort included 21 patients; however, the finger cuff was expired in 1 patient, resulting in no data collection, and the data from 2 other patients were lost in the download to the electronic medical record system.||mmHg||Standard Deviation|Mean
658674|NCT01896193|Secondary|Percentage of Participants Experiencing Virologic Relapse|Virologic relapse was defined as confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.|Up to Posttreatment Week 12|Full Analysis Set||percentage of participants|||Number
658675|NCT01896193|Secondary|Percentage of Participants Experiencing On-treatment Virologic Failure|"On-treatment virologic failure was defined as
Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)"|Up to 24 weeks|Full Analysis Set||percentage of participants|||Number
658676|NCT01896193|Secondary|Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set||percentage of participants|||Number
658677|NCT01896193|Primary|Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)|The percentage of participants permanently discontinuing any study drug due to an adverse event was summarized.|Up to 24 weeks|Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug||percentage of participants|||Number
658678|NCT01896193|Primary|Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants with genotype 1 or 3 HCV infection who were randomized and received at least one dose of study drug||percentage of participants|||Number
658679|NCT01896115|Other Pre-specified|Finger Tapping Amplitude - Pulse Width and Dorsal-Ventral Steering|Severity of finger-tapping bradykinesia was measured by a motion sensor system (Kinesia System) at 60 µs, 30 µs, and dorsal and ventral current steering settings. Stimulation was at amplitudes defined as the therapeutic threshold for rigidity. The Kinesia System was worn by patients to measure motion parameters including linear acceleration and angular velocity during different tasks, then provided an output score on a scale of 0 (no symptoms) to 4 (severe symptoms).|Day 1 programming visit|||units on a scale||Standard Deviation|Mean
658680|NCT01896115|Other Pre-specified|Resting Tremor Severity - Pulse Width and Dorsal-Ventral Steering|Resting tremor was measured by a motion sensor system (Kinesia System) at 60 µs, 30 µs, and current steering settings, at amplitudes defined as the therapeutic threshold for rigidity. The Kinesia System was worn by patients to measure motion parameters including linear acceleration and angular velocity during different tasks, then provided an output score on a scale of 0 (no symptoms) to 4 (severe symptoms).|Day 1 programming Visit|||units on a scale||Standard Deviation|Mean
658681|NCT01896115|Other Pre-specified|Dorsal-Ventral Current Steering Therapeutic Window|The therapeutic window refers to the range of stimulus amplitudes that provide a therapeutic effect without side effects. In other words, this measure reports the stimulus amplitude difference between the full rigidity control threshold and the first stimulation induced side effect threshold at current steering settings (current divided 50% between adjacent electrodes).|Day 1 programming visit|The therapeutic window of short pulse widths vs. conventional pulse widths was a primary outcome measure and is reported as such in another section of this report.||mA||Standard Deviation|Mean
658682|NCT01896115|Secondary|Finger Tapping Amplitude - Single Contact vs. Steering|Severity of finger-tapping bradykinesia was measured by a motion sensor system (Kinesia System) when either using a single contact or steering current between two contacts. Stimulation was at amplitudes defined as the therapeutic threshold for rigidity. The Kinesia System was worn by patients to measure motion parameters including linear acceleration and angular velocity during different tasks, then provided an output score on a scale of 0 (no symptoms) to 4 (severe symptoms).|Day 1 programming visit|The 24 patients reported here are a separate population from the 16 patients who were enrolled for primary endpoint analysis (40 total patients).||units on a scale||Standard Deviation|Mean
658683|NCT01896115|Secondary|Resting Tremor Severity - Single Contact vs. Steering|Resting tremor was measured by a motion sensor system (Kinesia System) while either using a single contact or steering current between two contacts. Stimulation was at amplitudes defined as the therapeutic threshold for rigidity. The Kinesia System was worn by patients to measure motion parameters including linear acceleration and angular velocity during different tasks, then provided an output score on a scale of 0 (no symptoms) to 4 (severe symptoms).|Day 1 programming visit|The 24 patients reported here are a separate population from the 16 patients who were enrolled for primary endpoint analysis (40 total patients).||units on a scale||Standard Deviation|Mean
658868|NCT01892267|Secondary|Short-term Complications|Short-term complications will include stomal (Infection, erythema, bleeding, pain and secretion, etc) and tube (Clotting, dislocation, defect, aspiration, etc) complications detected in the first week.|One week|||participants|||Number
658684|NCT01896115|Secondary|Side Effect Thresholds - Single Contact vs. Steering|This endpoint determined how much current (mA) could be applied before side effects appeared when using 60 microsecond pulse widths. Values were obtained for when current was delivered through a single contact or divided between two contacts (steering).|Day 1 programming visit|The 24 patients reported here are a separate population from the 16 patients who were enrolled for primary endpoint analysis (40 total patients).||mA||Standard Deviation|Mean
658685|NCT01896115|Primary|Unified Parkinson's Disease Rating Scale III|"The Unified Parkinson's Disease Rating Scale (UPDRS) has four sections (I-IV) that ask patients to rate aspects of their mental state including mood (I), aspects of daily activities (II), aspects of motor function (III), and complications of treatment (IV). Here, we ask subjects to rate their motor function (UPDRS III) following interventions with 30 µs and 60 µs pulse width DBS settings.
The UPDRS III scale has 14 categories including speech, facial expression, tremor at rest, action tremor, rigidity, finger tapping ability, ability to open and close hands, ability to rapidly alternate hand movements, leg agility, ability to rise from a chair, posture, gait, response to postural displacement (e.g., push), and bradykinesia. Patients rate each of these categories from 0 to 4, with 0 being normal function and 4 being the worst. Categories assessing appendages are rated for both left and right sides, allowing a maximum score (worst outcome) of 108."|Day 1 programming visit|All subjects were analyzed at both pulse widths. Primary outcomes were only intended to be assessed for different pulse widths and not current steering.||UPDRS III score||Standard Deviation|Mean
658686|NCT01896115|Primary|Therapeutic Window|The therapeutic window refers to the range of stimulus amplitudes that provide a therapeutic effect without side effects. In other words, it is the amplitude difference between the first stimulation-induced side effect threshold (e.g., eye deviation, muscle contraction, and speech) and full rigidity control threshold at 60 µs and 30 µs pulse width DBS settings.|Day 1 programming visit|"Therapeutic window for current steering settings was not a primary outcome measure but is described later as an Other outcome measure."||mA||Standard Deviation|Mean
658687|NCT01896050|Secondary|Association Between Baseline Body Mass Index and Discontinuation of Aromatase Inhibitor Therapy Within the First 12 Months|Associations between baseline BMI and whether or not aromatase inhibitor-treated patients discontinued treatment by 12 months. In the original statistical analysis plan, it was only intended to examine the association with aromatase inhibitor-treated patients, and not tamoxifen-treated patients. The numbers below reflect the number of patients in each group who discontinued initial endocrine therapy within the first 12 months of treatment|baseline and 12 months|||participants|||Number
658688|NCT01896050|Secondary|Effect of Medication on Change in Grip Strength|Effect of either aromatase inhibitor or tamoxifen therapy on change in grip strength between baseline and 12 months|baseline and 12 months|||percent change||Standard Deviation|Mean
658689|NCT01896050|Primary|Effect of Change in Body Mass Index on Change in Grip Strength With Aromatase Inhibitor Therapy|Change in BMI between baseline and 12 months of endocrine therapy|baseline and 12 months|These data only include patients who completed a full 12 months of treatment with either an aromatase inhibitor or tamoxifen and had grip strength data at both baseline and 12 months. Patients could have switched from one aromatase inhibitor to another. Those patients who discontinued treatment prior to the 12 month period were excluded.||kg/m^2||Standard Deviation|Mean
658690|NCT01895946|Secondary|Efficacy: Progression-free Survival (PFS)|PFS is defined as the time from randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the subject withdraws from randomised therapy or receives another anti-cancer therapy prior to progression. Subjects who have not progressed or died at the time of analysis were censored at the time of the latest date of assessment from their last evaluable RECIST assessment. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a nontarget lesion, or the appearance of new lesions.|Assessed every 6 weeks up to 36 weeks|Modified intent-to-treat analysis set: all patients who received at least one dose of study treatment with a baseline tumour assessment.||weeks||Inter-Quartile Range|Median
658691|NCT01895946|Secondary|Efficacy: Target Lesion Size, Best Percentage Change From Baseline|"Tumour size is the sum of the longest diameters of the target lesions. Target lesions are measurable tumour lesions.
best percentage change in tumour size from baseline is the maximum reduction from baseline or the minimum increase from baseline in the absence of a reduction from baseline based on all post baseline assessments."|Assessed every 6 weeks up to 36 weeks|Modified intent-to-treat analysis set: all patients who received at least one dose of study treatment with a baseline tumour assessment.||Percentage change from baseline||Standard Deviation|Mean
658692|NCT01895946|Secondary|Efficacy: Target Lesion Size, Percentage Change From Baseline at Week 12|"Tumour size is the sum of the longest diameters of the target lesions. Target lesions are measurable tumour lesions.
The percentage change in target lesion tumour size at each week 12 for which data are available was obtained for each subject taking the difference between the sum of the target lesion at each week 12 and the sum of the target lesions at baseline divided by the sum of the target lesions at baseline multiplied by 100 (i.e. (week 12) - baseline)/baseline * 100)."|Week 12|Modified intent-to-treat analysis set: all patients who received at least one dose of study treatment with a baseline tumour assessment.||Percentage change from baseline||Standard Deviation|Mean
658693|NCT01895946|Secondary|Efficacy: Disease Control at Week 12|Disease control = confirmed complete response + confirmed partial response + stable disease at 12 weeks|Week 12|Modified intent-to-treat analysis set: all patients who received at least one dose of study treatment with a baseline tumour assessment.||Participants|||Number
658708|NCT01895543|Secondary|Change From Baseline in EuroQol Group Visual Analog Scale (EQ-VAS) Score|"The EQ VAS presents the participant's self-evaluated health on a 20 cm vertical, visual analogue scale with endpoints labelled ‘the best health you can imagine’ and ‘the worst health you can imagine’. This scale is numbered from 0 to 100, where '100' means best health you can imagine and '0' means worst health you can imagine. The participant simply mark an 'X' on the scale to indicate how his/her health is TODAY and mention the same number in a box provided."|At Week 12, 24, 36 and 52|Safety Analysis Set||Unit on a scale||Standard Deviation|Mean
659176|NCT01885559|Secondary|Pain|Kidney pain (back or flank pain) experienced in since last visit|48 months|Cross sectional analysis at 48 months is reported only for those participants responding at that time point. Intention to treat analysis was used for in the modeling over time to incorporate all repeated measures.||percentage of participants at 48 months||95% Confidence Interval|Number
658694|NCT01895946|Secondary|Efficacy: Best Objective Response (BOR)|"Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 guidelines for measurable, non-measurable, target lesions (TLs) and non-target lesions (NTLs) and the objective tumour response criteria was used.
Categorisation of objective tumour response assessment was based on the RECIST 1.1 guidelines for response: CR (complete response, efined as disappearance of all target lesions), PR (partial response, defined as >=30% decrease in the sum of the longest diameter of target lesions), SD (stable disease, defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression) and PD (progression of disease, defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a nontarget lesion). BOR was the best overall response observed across the study and up to 36 weeks. Number of subjects with response (CR or PR) is described."|Assessed every 6 weeks, up to 36 weeks|Modified intent-to-treat analysis set: all patients who received at least one dose of study treatment with a baseline tumour assessment.||Participants|||Number
658695|NCT01895946|Primary|Ratio of AUCss for Day 4 to Day 11|"The actual sampling times were used in the parameter calculations and PK parameters were derived using standard non-compartmental methods.
Following the twice daily dosing in Cycle 1 at Day 4 and 11 for both the formulation switch and food effect investigations, the following PK parameters have been determined:
Css max, tss max, Css min, area under the plasma concentration-time curve from zero to the end of the dosing interval (AUCss) and CLss/F.
Css max, tss max were determined by inspection of the concentration-time profiles. AUCss was calculated using the linear up / log down trapezoidal rule. CLss/F was determined from the ratio of dose/AUCss.
Ratio of AUCss for Day 4 to Day 11 have been derived."|Day 4 and Day 11|All patients who provided concentration-time data for AZD5363 for both capsule and tablet administration (Part A) or for both fed and fasted treatments and who were compliant with the standard dietary and evaluability requirements (Part B) were included in PK analysis set.||Ratio||90% Confidence Interval|Geometric Mean
658696|NCT01895946|Primary|Ratio of Css,Max for Day 4 to Day 11|"The actual sampling times were used in the pharmacokinetics (PK) parameter calculations and PK parameters were derived using standard non-compartmental methods.
Following the twice daily dosing in Cycle 1 at Day 4 and 11 for both the formulation switch and food effect investigations, the following PK parameters have been determined:
Maximum plasma concentration at steady state (Css max), time to Css,max (tss max), minimum plasma concentration at steady state (Css min), area under the plasma concentration-time curve from zero to the end of the dosing interval (AUCss) and apparent clearance (CLss/F).
Css max, tss max were determined by inspection of the concentration-time profiles. AUCss was calculated using the linear up / log down trapezoidal rule. CLss/F was determined from the ratio of dose/AUCss.
Ratio of Css,max for Day 4 to Day 11 have been derived."|Day 4 and Day 11|All patients who provided concentration-time data for AZD5363 for both capsule and tablet administration (Part A) or for both fed and fasted treatments and who were compliant with the standard dietary and evaluability requirements (Part B) were included in PK analysis set.||Ratio||90% Confidence Interval|Geometric Mean
658697|NCT01895634|Secondary|All Cause Mortality||90 days post-procedure|||participants|||Number
658698|NCT01895634|Secondary|Proportion of Patients With Symptomatic and Asymptomatic Intracranial Hemorrhage (ICH)||24-hour post procedure|Missing value was not be imputed (1 missing subject was because of the death within 24 hours)||participants|||Number
658699|NCT01895634|Secondary|Neurological Outcome: Proportion of mRS 0-2 at 90 Days Post Procedure|"The Modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6, running from perfect health without symptoms to death, or similar, as accurate."|90 days post procedure|Missing value was not be imputed (1 missing subject was because of the missing data at 90 days by subject IC withdrawal)||participants|||Number
658700|NCT01895634|Secondary|Proportion of Subject Who Have Clot Migration/Embolization||immediately post procedure|||participants|||Number
658701|NCT01895634|Primary|Proportion of Patients Who Have Recanalization|Proportion of subjects who had recanalization, TICI 2a or better|immediately post procedure|||participants|||Number
658702|NCT01895608|Secondary|Change Scores in Activities-specific Balance-related Confidence|Subjects' decreased confidence in a variety of situations will be measured using the Activities-specific Balance Confidence scale which has good test-retest reliability. Sixteen activities are each assessed on a scale ranging from 0 to 100, where higher scores indicate greater confidence in performing the activity. Item scores are averaged to arrive at a final score, where average scores <67% indicate a greater fall risk.|baseline and 6 weeks|||overall percentage of confidence||Standard Deviation|Mean
658703|NCT01895608|Secondary|Change Scores in Preferred Gait Speed|Subjects walk at their preferred speed and time to walk 6 m is recorded.|baseline and 6 weeks|||meters per second||Standard Deviation|Mean
658704|NCT01895608|Secondary|Change Scores in Sensory Organization Test (SOT)|"SOT is organized into a series of 6 conditions of increasing difficulty: 3 involve a firm surface with eyes open, eyes closed and with vision sway-referenced and 3 involve a sway-referenced surface with eyes open, eyes closed, and with vision sway-referenced. SOT has good reliability and differentiates fallers and nonfallers.
The SOT composite score is used for statistical analysis with a maximum score of 100 (indicating perfect stability) and a minimum score of 0 (indicating severe instability). Higher scores indicate better performance (i.e., greater postural stability) and SOT composite scores less than 38 out of 100 indicate fall risk."|baseline and 6 weeks|||units on a scale||Standard Deviation|Mean
658705|NCT01895608|Secondary|Change Scores in Dynamic Gait Index|"Dynamic Gait Index (DGI) assesses gait under 8 conditions and has excellent interrater as well as test-retest reliability.
Each of the 8 conditions is scored on a scale from 0 (indicating severe impairment) to 3 (indicating normal ability). The total score is used for statistical analysis with a maximum score of 24 and a minimum score of 0 with a higher score indicating better performance. A total DGI score less than 20 out of 24 indicates fall risk."|baseline and 6 weeks|||units on a scale||Standard Deviation|Mean
658706|NCT01895608|Secondary|Change Scores in Walk While Talk Test With Verbal Fluency Task|The walk while talk (WWT) test involves walking at preferred speed while performing a verbal fluency task.|baseline and 6 weeks|||seconds||Standard Deviation|Mean
658707|NCT01895608|Primary|Change Scores in Timed up and go With Cognitive Task|Timed up and go test (TUG) has three conditions: no secondary task (TUG), cognitive (TUGc) and manual dual-tasks (TUG-m). Time to complete the task with the cognitive task was recorded as a primary outcome measure. Time greater than 15 s for TUG-c indicates impaired dual-task ability.|baseline and 6 weeks|||seconds||Standard Deviation|Mean
658709|NCT01895543|Secondary|Change From Baseline in EuroQol Group 5-Dimensions 5-Level Questionnaire (EQ-5D-5L) Scores|EQ-5D-5L is a standardised measure of health status developed to provide a simple, generic measure of health for clinical and economic appraisal. The EQ-5D-5L descriptive system comprises the following five dimensions: mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels (1-5 denotes): no problems, slight problems, moderate problems, severe problems, and extreme problems, respectively. A unique health state was defined by combining 1 level from each of the 5 dimensions. Each health state was converted into a single EQ-5D-5L index value. The index values are country specific and values specified for United Kingdom (UK) were used for this study. The index value range for UK lies between -0.594 - 1.000. A positive index value represents better health status while the negative value represents poor health status.|At Week 12, 24, 36 and 52|Safety Analysis Set||Unit on a scale||Standard Deviation|Mean
658710|NCT01895543|Primary|Number of Patients Using Concomitant Medications|The concomitant medications details were collected throughout the trial at all visits. Data were obtained at scheduled or unscheduled trial visits based on information provided spontaneously by the patient or as a result of questioning the patient.|For the overall 52-week Treatment Period|Safety Analysis Set||Patients|||Number
658711|NCT01895543|Secondary|Change From Baseline in Patient Assessment of Constipation - Quality of Life (PAC-QOL): Overall Score|PAC-QOL is a 28-item questionnaire for psychometric assessment of disease-specific QOL. The questionnaire is based on a 5-point Likert scale; ranging from 0 [none of the time or not at all] to 4 [all of the time or extremely]). A lower score indicates a better QOL. The PAC-QOL questionnaire is developed specifically for patients with constipation. PAC-QOL has four sub-scales: ‘Worries and Concerns’, ‘Physical Discomfort’, ‘Psychosocial Discomfort’, and ‘Dissatisfaction’.|At Week 12, 24, 36 and 52|Safety Analysis Set||Unit on a scale||Standard Deviation|Mean
658712|NCT01895543|Secondary|Change From Baseline in Global Evaluation of Treatment Effectiveness|The treatment effectiveness score was measured on a 5-point scale (1: extremely effective, 2: quite a bit effective, 3: moderately effective, 4: little bit effective, 5: not at all effective).|At Week 12, 24, 36, and 52|Safety Analysis Set||Unit on a scale||Standard Deviation|Mean
658713|NCT01895543|Secondary|Change From Baseline in Global Evaluation of Constipation Severity|The constipation severity score was measured on a 5-point scale (1: none to 5: very severe).|At Week 12, 24, 36, and 52|Safety Analysis Set||Unit on a scale||Standard Deviation|Mean
658714|NCT01895543|Secondary|Use of Concomitant Over-the-counter (OTC) Laxatives|The use of OTC laxatives during the trial was assessed based upon the concomitant medication module of the electronic Case Report Form (eCRF).|For the overall 52-week Treatment Period|Safety Analysis Set||Patients|||Number
658715|NCT01895543|Primary|Incidence of Markedly Abnormal Changes in Body Weight and Vital Signs|Vital signs were measured at all visits and included blood pressure (BP: measured after the patient had been in a seated position for ≥3 minutes of rest), pulse, respiration rate, body temperature, and body weight.|For the overall 52-week Treatment Period|Safety Analysis Set||Patients|||Number
658716|NCT01895543|Primary|Incidence of Markedly Abnormal Changes in Electrocardiograms (ECGs)|A routine 12-lead ECG was performed at all visits. The ECG included heart rate, PR, QRS, and QT intervals assessment.|For the overall 52-week Treatment Period|Safety Analysis Set||Patients|||Number
658717|NCT01895543|Primary|Incidence of Markedly Abnormal Changes in Clinical Safety Laboratory Variables|Outcome measure include laboratory parameters from haematology, coagulation and clinical chemistry|For the overall 52-week Treatment Period|Safety Analysis Set||Patients|||Number
658718|NCT01895543|Primary|Number of Patients With Adverse Events (AEs) and Serious Adverse Events (SAEs)|The Investigator recorded all AEs throughout the trial from the time of obtaining informed consent till the last visit (i.e., Visit 6). Information on AE was collected at each visit. All AEs were recorded in AE log for each patient.|For the overall 52-week Treatment Period|Safety Analysis Set||Patients|||Number
658719|NCT01895452|Secondary|Mean Change From Baseline to Endpoint in Clinical Global Impression - Severity (CGI-S) Over Time|"The CGI-S is a 7-point scale that requires the clinician to assess how mentally ill the patient is in a specific point in time. Results indicate participants evaluated at one of the following categories: 1: normal, not at all ill; 2: borderline mentally ill; 3: mildly ill; 4: moderately ill; 5: markedly ill; 6: severely ill; and 7: among the most extremely ill patients. Results indicate a change in CGI-S score from baseline to Day 365 based on the observed data. Change is calculated between the baseline visit and the subject's last visit in the treatment period."|Up to 12 months|The full analysis set consists of all subjects who received at least 1 dost of ALKS 9072 and had at least 1 postbaseline assessment of PANSS score after administration of ALKS 9072.||units on a scale||Standard Deviation|Mean
658720|NCT01895452|Secondary|Change in Baseline of Positive and Negative Syndrome Scale (PANSS) Total Score Over Time|This scale consists of symptom constructs (7 positive, 7 negative, 16 general psychopathology), each to be rated on a 7-point Likert-type scale of severity with 1 being absent to 7 being extreme. Minimum scores (best outcome) equals 30 (total scale); maximum scores (worst outcome) equals 210 (total scale). Change is calculated between the baseline visit and the subject's last visit in the treatment period.|Up to 12 months|The full analysis set consisted of all subjects who received at least 1 dose of ALKS 9072 and had at least 1 postbaseline assessment of PANSS total score after administration of ALKS 9072.||units on a scale||Standard Deviation|Mean
658721|NCT01895452|Primary|Number and Percentage of Subjects With Treatment-emergent Adverse Events (TEAEs)|This measure includes all incidences, including those that occurred >5%.|Up to 12 months|Safety population includes all subjects who received at least 1 dose of ALKS 9072 in the current study.||Participants|||Count of Participants
658722|NCT01895335|Secondary|Expanded Disability Status Scale (EDSS) Score at Baseline and Week 48|EDSS is a method of quantifying disability in MS participants and monitoring changes in the level of disability over time. EDSS quantifies disability in 8 functional systems: pyramidal, cerebellar, brainstem, sensory, bowel and bladder, visual, cerebral, and other. EDSS scale ranges from 0 to 10 in 0.5 unit increments that represents higher levels of disability. EDSS score 1.0 to 4.5 refers to people with MS who are fully ambulatory; EDSS score 5.0 to 9.5 refers to impairment to ambulation; EDSS score 10 refers to death due to MS.|Baseline, Week 48|Analysis was performed on Efficacy population. Number of participants analyzed=participants with available data at specified time point. Here, ‘n’ signifies number of participants with available data for specified category.||units on a scale||Standard Deviation|Mean
658750|NCT01895062|Secondary|The Incidence of Subjects With One or More RI in the cNEP Group Compared to the no cNEP Group.||1 hour||||||
658723|NCT01895335|Secondary|Change From Baseline in Stern Leisure Activity Scale at Week 48|The Stern Leisure Activity Scale is a self-reported scale that consists of 13 questions assessing the participant’s participation in leisure activities during the preceding month. One point is given for participation in each of the 13 activities and an aggregate score (range from 0 to 13) is obtained. ≤ 6 score is considered as low leisure activity and > 6 score as high leisure activity.|Baseline, Week 48|Analysis was performed on Efficacy population. Number of participants analyzed=participants with available data at specified time point.||units on a scale||Standard Deviation|Mean
658724|NCT01895335|Secondary|Change From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Score at Week 48|The MusiQoL is a quality of life questionnaire that consists of 31 questions, divided into 9 dimensions: activities of daily living, physiological well-being, symptoms, relationship with friends, relationship with family, sentimental and sexual life, coping, rejection and relationship with healthcare system. All the 9 dimension scores and the global scores are linearly transformed and standardized on 0 (worst outcome) -100 (best outcome) scale. Higher scores represents higher quality of life.|Baseline, Week 48|Analysis was performed on Efficacy population. Number of participants analyzed=participants with available data at specified time point.||units on a scale||Standard Deviation|Mean
658725|NCT01895335|Secondary|Duration of Teriflunomide Treatment Exposure|Duration of exposure was defined as last dose date – first dose date + 1 day, regardless of unplanned intermittent discontinuations and regardless of dosage administered (14 mg or 7 mg).|Baseline up to end of treatment (up to Week 48)|Analysis was performed on Safety population.||Days||Standard Deviation|Mean
658726|NCT01895335|Secondary|Percentage of Participants With Treatment Compliance of ≥80% During the Study Treatment Period|Percentage of compliance for a participant was defined as the number of days that the participant was compliant (1 tablet/day) divided by the exposure duration in days (from the first dose administration to the last dose administration) times 100.|Baseline up to end of treatment (up to Week 48)|Analysis was performed on Safety population.||percentage of participants|||Number
658727|NCT01895335|Secondary|Overview of Adverse Events (AEs)|Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during from first study drug intake up to 112 days after last intake for participant with no accelerated elimination procedure (AEP) or to last AEP follow up visit for participants with AEP. A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.|From first study drug intake up to 112 days after last intake for participant with no AEP or to last AEP follow up visit for participants with AEP|Safety Population that included all treated participants who received at least 1 dose or part of a dose of IMP.||percentage of participants|||Number
658728|NCT01895335|Secondary|Change From Baseline in Cognition Measured by Symbol Digit Modalities Test (SDMT) Score at Week 48|SDMT measures the time to pair abstract symbols with specific numbers. It is a simple substitution task that gives the examinee 90 seconds to pair specific numbers with given geometric figures as a measure for screening cognitive impairment. The score is computed as a ratio of number of correct responses divided by the total number of responses. The test score range from 0 (worst outcome) to 1 (best outcome). Higher scores are indicative of better cognition function.|Baseline, Week 48|Analysis was performed on Efficacy population. Number of participants analyzed=participants with available data at specified time point.||units on a scale||Standard Deviation|Mean
658729|NCT01895335|Secondary|Time to Relapse: Kaplan-Meier Estimates of the Probability of Treated Relapse at Week 4, Week 24 and Week 48|A treated relapse was defined as a relapse treated by a systemic corticosteroid treatment or by another DMT. If a participant had no treated relapse before treatment discontinuation/completion, then the participant was considered as free of treated relapse until the date of treatment discontinuation/completion. Only treated relapse occurred during the treatment period (first drug administration to last drug administration) were considered for analysis. Kaplan-Meier method was used to estimate the probability of treated MS relapse at 4, 24 and 48 weeks.|Baseline up to end of treatment (up to Week 48)|Analysis was performed on Efficacy population.||percent probability of treated relapse||95% Confidence Interval|Number
658730|NCT01895335|Secondary|Annualized Treated Relapse Rate|Annualized treated relapse rate was defined as the total number of treated relapses during the study treatment period divided by the total number participants-years of treatment. Only events occurred during the treatment period (first drug administration to last drug administration) were considered for analysis.|Baseline up to end of treatment (up to Week 48)|Analysis was performed on Efficacy population.||relapses per patient-year|||Number
658731|NCT01895335|Secondary|Change From Baseline in Multiple Sclerosis Performance Scale (MSPS) Score at Week 24 and Week 48|MSPS was a self-reported measure for MS associated disability in which participants were asked to indicate the category that best described their condition during the past month on the following 8 subscales: mobility, hand function, vision, fatigue, cognitive symptoms, bladder/bowel, sensory symptoms and spasticity symptoms. MSPS used a single question to assess each of 8 subscales. All of the subscales ranged from 0= normal to 5= total disability, except mobility subscale which ranged from 0= normal to 6=total disability. Total MSPS score ranged from 0 =normal to 41=greater disability, where higher score reflected greater disability.|Baseline, Week 24, Week 48|Analysis was performed on Efficacy population. Here, ‘n’ signifies number of participants with available data at specified time points.||units on a scale||Standard Deviation|Mean
658732|NCT01895335|Secondary|Change From Baseline in Disease Progression Using Patient Determined Disease Steps (PDDS) Score at Week 48|PDDS scale developed to assess the disability in Multiple Sclerosis (MS) participants and in assessing disease progression that focuses mainly on how participants walk. PDDS scale consists of 0 = normal; 1 = mild disability; 2 = moderate disability; 3 = gait disability; 4 = early cane; 5 = late cane; 6 = bilateral support; 7 = wheelchair/scooter and 8 = bedridden. A higher score represented higher level of disability.|Baseline, Week 48|Analysis was performed on Efficacy population. Number of participants analyzed=participants with available data at specified time point.||units on a scale||Standard Deviation|Mean
658751|NCT01895062|Secondary|The Safety of cNEP as Determined by Adverse Events Reported by the Investigators.||1 hour||||||
658733|NCT01895335|Secondary|Change From Week 4 in TSQM Scores in Naïve Participants to Week 48|TSQM version 1.4 is a global satisfaction scale used to assess the overall level of participant’s satisfaction or dissatisfaction with their medications. It comprises of 14 items assessing the following 4 domains: effectiveness (questions: 1-3), side effects (questions: 4-8), convenience (questions: 9-11), global satisfaction (questions: 12-14). For each of the 4 domains the scores of the corresponding items were added based on an algorithm to create a score of 0 to 100. Higher scores indicated greater satisfaction.|Week 4, Week 48|Analysis was performed on Efficacy population. Number of participants analyzed=participants with available data at specified time point. Here, ‘n’ signifies number of participants with available data for specified category.||units on a scale||Standard Deviation|Mean
658734|NCT01895335|Secondary|Change From Baseline in TSQM Scores in Participants Switching From Another Disease Modifying Therapy (DMT) at Week 4 and Week 48|TSQM version 1.4 is a global satisfaction scale used to assess the overall level of participant’s satisfaction or dissatisfaction with their medications. It comprises of 14 items assessing the following 4 domains: effectiveness (questions: 1-3), side effects (questions: 4-8), convenience (questions: 9-11), global satisfaction (questions: 12-14). For each of the 4 domains the scores of the corresponding items were added based on an algorithm to create a score of 0 to 100. Higher scores indicated greater satisfaction .|Baseline, Week 4, Week 48|Analysis was performed on Efficacy population. Number of participants analyzed=participants with available data at specified time point. Here, ‘n’ signifies number of participants with available data for specified category.||units on a scale||Standard Deviation|Mean
658735|NCT01895335|Primary|Treatment Satisfaction Questionnaire for Medication (TSQM) Version 1.4 – Assessment of Global Satisfaction Subscale Score With Teriflunomide Treatment at Week 48|"TSQM version 1.4 is a global satisfaction scale used to assess the overall level of participant’s satisfaction or dissatisfaction with their medications. It comprises of 14 items assessing the following 4 domains: effectiveness (questions: 1-3), side effects (questions: 4-8), convenience (questions: 9-11), global satisfaction (questions:12-14).
Primary outcome was the global satisfaction score. The score of the corresponding item was added based on the algorithm to create a score of 0 to 100. Higher score indicated greater satisfaction in that domain."|Week 48|Efficacy population that included all treated participants. Number of participants analyzed = participants with available data at specified time point.||units on a scale||Standard Deviation|Mean
658736|NCT01895322|Secondary|Percent Change in Body Weight|Percent change in body weight from baseline during the repeated-administration period(For five days).|100%*<Body weight on day13 minus Body weight at baseline (day9)/Body weight at baseline(day9)>|||Percentage||Standard Deviation|Mean
658737|NCT01895322|Primary|Percent Change in Daily Urine Volume From Baseline|Percent change in daily urine volume from baseline during the repeated-administration period (For five days).|100%*<Urine Volume on day13 minus Urine Volume at baseline(day9) on the repeated-administration period/Urine Volume at baseline(day9) on the repeated-administration period>|||Percentage||Standard Deviation|Mean
658738|NCT01895322|Secondary|Change in Body Weight From Baseline|Change in body weight from baseline during the repeated-administration period(For five days).|Body weight on day13 minus Body weight at baseline(day9) on the repeated-administration period|||kg||Standard Deviation|Mean
658739|NCT01895322|Primary|Change in Daily Urine Volume From Baseline|Change in daily urine volume from baseline during the repeated-administration period (For five days).|Urine Volume on day13 minus Urine Volume at baseline(day9) on the repeated-administration period.|||mL||Standard Deviation|Mean
658740|NCT01895309|Secondary|American College of Rheumatology 50% Response Criteria (ACR50)||Week 24, Week 52|||percentage of participants|||Number
658741|NCT01895309|Secondary|ACR20||Week 52|||percentage of participants|||Number
658742|NCT01895309|Primary|American College of Rheumatology 20% Response Criteria (ACR20)||Week 24|||percentage of participants|||Number
658743|NCT01895270|Primary|Change Over Time in Illicit Opioid Use Via Urine Toxicology Screens During Buprenorphine Taper (Wks 5-6)|Illicit results via urine toxicology screens for heroin and several opioids will be measured thrice weekly during the taper|thrice weekly for approx 2 weeks (taper)|Urine data of subjects that received at least one dose of isradipine and returned for at least one visit in which a urine drug screen was obtained were included in the analysis||opioid-positive urine|Urine drug screen results|Standard Error|Least Squares Mean
658744|NCT01895127|Primary|Percent Change in Estimated Glomerular Filtration (eGFR) Rate|Percent change in eGFR rate at 3 months post-treatment using the modified Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.|Month 3|1 subject in the SOC arm received rescue therapy, per protocol, with eculizumab following PP/IVIg. 1 subject in the Soliris arm received SOC therapy (PP/IVIg) following completion of Soliris treatment period. Both of these subjects received both SOC and Soliris treatment prior to Month 3 protocol biopsy so we have listed their outcome separately.||percent change in eGFR from wk 0 to mo 3||Full Range|Mean
658745|NCT01895101|Secondary|Total Red Blood Cell Transfusions (Cumulative of Pre, Peri and Postoperative Period)|The amount of red blood cell transfusions the patient receive pre, peri and postoperatively during their stay in the hospital.|participants will be followed for the duration of ICU stay, an expected average of 2 days/ And participants will be followed for the duration of hospital stay, an expected average of 3 weeks|||IU||Standard Deviation|Mean
658746|NCT01895101|Secondary|Number of Participants Requiring Surgical Re-exploration|the secondary objective of this study is to determine whether pericardial lavage with saline gives an improvement in haemostasis, compared with no pericardial lavage, resulting in a reduction of surgical re-explorations and post-operative 12-hour blood loss. The choice for a surgical re-exploration will be decided according to the ICU protocol.|participants will be followed for the duration of ICU stay, an expected average of 2 days|||participants|||Number
658747|NCT01895101|Primary|Postoperative Blood Loss|The primary study parameter is 12 hours postoperative blood loss and is assessed by postoperative chest tube production. Postoperative chest tube production 12 hours after surgical procedure|12 hours postoperative|||ml||Inter-Quartile Range|Median
658748|NCT01895088|Primary|Change (Increase) in Uncorrected Near Visual Acuity|The change in the number of lines of threshold visual acuity achieved postoperatively.|Baseline and 2 years|||lines of visual acuity improvement||Standard Deviation|Mean
658749|NCT01895062|Secondary|The Frequency of Interventions to Alleviate RI in the cNEP Group Compared to the no cNEP Group.|interventions such as reduction of sedative medication or jaw thrust.|1 hour|||interventions to restore airway|||Number
658752|NCT01895062|Primary|RI Events in the cNEP Group Compared to the no cNEP Group, Where RI is Defined as Either: i Oxygen Saturation < 90% or ii. Apneas/Hypopneas of > 15 Sec Duration i. Oxygen Saturation <90% ii. Presence of Apneas or Hypopneas|Mean RI events in the no cNEP group was 3.5 compared to 1.92 in the cNEP group (p=0.022)|1 hour|Not all subjects were evaluable due to malfunction of the respiratory monitoring equipment in several.||RI events||95% Confidence Interval|Mean
658753|NCT01895036|Primary|Successful Discontinuation of Buprenorphine|Number of individuals successfully discontinuing buprenorphine during the inpatient phase and through follow-up.|7 weeks|||Participants|||Count of Participants
658754|NCT01894984|Secondary|Number of Participants With Reasons for Discontinuation From Study Treatment|Number of participants with reasons for discontinuation from study treatment is reported here because participants provided multiple reasons for discontinuation.|Month 6|Analysis population included all enrolled participants.||Participants|||Number
658755|NCT01894984|Secondary|Percentage of Participants Attaining Remission Criteria|Remission is defined as a clinical status where for each core symptoms (that are, delusions, conceptual disorganization, hallucinatory behavior, mannerisms and posturing unusual thought content, blunted affect, passive or apathetic social withdrawal and lack of spontaneity and flow of conversation) were assessed at a low-mild symptom intensity level, where such absent, borderline, or mild symptoms do not influence an individual’s behavior.|Month 6|ITT population included all randomized participants who received at least one dose of study drug and had relevant efficacy evaluations.||Percentage of Participants|||Number
658756|NCT01894984|Secondary|Percentage of Participants With Relapse at Week 24|Percentage of participants with relapse was assessed wherein relapse was defined as hospitalization due to the aggravation of psychiatric symptoms of disease condition.|Week 24|ITT population included all randomized participants who received at least one dose of study drug and had relevant efficacy evaluations.||Percentage of Participants|||Number
658757|NCT01894984|Secondary|Clinical Global Impressions-Severity (CGI-S) Score|"The CGI-S rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher scores indicate worsening."|Baseline and Week 24|ITT population included all randomized participants who received at least one dose of study drug and had relevant efficacy evaluations.||units on a scale||Standard Deviation|Mean
658758|NCT01894984|Secondary|Total Personal and Social Performance (PSP) Score|The PSP is a clinician-rated scale that reflects social functioning in 4 domains of behavior (socially useful activities including work and study, personal and social relationships, self care, and disturbing and aggressive behaviors). The total score ranges from 1 to 100 (score of 71 to 100 will have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision) divided into 10 equal intervals to rate the degree of difficulty (i=absent to vi=very severe) in each of the 4 domains.|Baseline and Week 24|ITT population included all randomized participants who received at least one dose of study drug and had relevant efficacy evaluations.||units on a scale||Standard Deviation|Mean
658759|NCT01894984|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 24|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Baseline and Week 24|Intent to treat (ITT) population included all randomized participants who received at least one dose of study drug and had relevant efficacy evaluations.||units on a scale||Standard Deviation|Mean
658760|NCT01894906|Secondary|Dialysate OutFlow Iron Concentration|Dialysate outflow iron concentration was calculated for each treatment group at t = 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, and 4 hours.|4 hours|For this preliminary and explorative study, no prospective calculations of statistical power were made; statistics were descriptive only. All subjects were included in the calculation of all study outcomes.||micrograms/L||Standard Deviation|Mean
658761|NCT01894906|Secondary|Dialysate InFlow Iron Concentration|Dialysate inflow iron concentration was calculated for each treatment group at t = 0, 0.5, 1, 2, 3, and 4 hours.|4 hours|For this preliminary and explorative study, no prospective calculations of statistical power were made; statistics were descriptive only. All subjects were included in the calculation of all study outcomes.||micrograms/L||Standard Deviation|Mean
658762|NCT01894906|Primary|Net Iron Delivery From SFP Via the Dialysate|To measure the SFP-derived total iron from the reference HD (Treatment B: SFP, new membrane, high Qb/Qd, 37 mEq bicarbonate). Expended dialysate over the intervals of 0.5, 1, 2 ,3 and 4 hours will be collected and measured. Aliquots will be analyzed for iron content. The mean cumulative net iron delivery will be reported.|one dialysis session (approximately 4 hours)|For this preliminary and explorative study, no prospective calculations of statistical power were made; statistics were descriptive only. All subjects were included in the calculation of all study outcomes.||microgram||Standard Deviation|Mean
658763|NCT01894906|Secondary|Pharmacokinetics of Serum Iron and Exploratory Modeling|The serum Total Iron, Transferrin Bound Iron (TBI) and Non-transferrin Bound Iron (NTBI) pharmacokinetic parameters (baseline corrected and total) will be listed and summarized for each membrane group and overall. The mean serum total iron, TBI, NTBI, unsaturation iron binding capacity (UIBC) and total iron binding capacity (TIBC) concentrations at baseline (BL), end-of-treatment, and the change from BL will be listed for each group (Baxter and Gambro Polyflux), measured from the reference HD (Treatment B: SFP, new membrane, high Qb/Qd, 37 mEq bicarbonate).|one dialysis session (approximately 4 hours)|For this preliminary and explorative study, no prospective calculations of statistical power were made; statistics were descriptive only. All subjects were included in the calculation of all study outcomes.||microgram/dL||Standard Deviation|Mean
658778|NCT01894256|Primary|CLR of Olaparib|Renal clearance of olaparib, calculated as the ratio of amount of drug excreted over 24 hours to AUC0-24|Part A: Day 1, 0-12 hours and 12-24 hours post-dose|"Subset of PK analysis set with urine samples available. PK analysis set: All patients who receive an olaparib dose and have full PK sampling up to 96 hours post-dose.
Any patients with major protocol deviations that affected the evaluability of the PK profile were excluded."||L/hour||Standard Deviation|Mean
661387|NCT01842464|Primary|The Change With Distance Between the Vaginal Apex and the Introitus|The change with distance measured by centimeters, between the vaginal apex and the introitus|One year|||centimeters||Full Range|Mean
658764|NCT01894906|Secondary|To Compare the Amount of SFP-derived Iron Administered Under Various Treatment Conditions to the Reference HD|To compare the amount of SFP-derived iron administered under various treatment conditions to the reference HD (Treatment B: SFP, new membrane, high Qb/Qd, 37 mEq bicarbonate): Dialyzer reuse, Low machine bicarbonate delivery, Polyarylethersulfone (PAES) membrane, and Low Qb/Qd.Iron concentration in timed dialysate collections will be analyzed. Expended dialysate over the intervals of 0.5, 1, 2 ,3 and 4 hours will be collected and measured. Aliquots will be analyzed for iron content. The mean cumulative net iron delivery will be reported.|one dialysis session (approximately 4 hours)|For this preliminary and explorative study, no prospective calculations of statistical power were made; statistics were descriptive only. All subjects were included in the calculation of all study outcomes.||microgram||Standard Deviation|Mean
658765|NCT01894672|Other Pre-specified|Pharmacokinetic (PK) Analysis: Geometric Mean of Maximum Observed Concentration (Cmax) of LGX818 at Steady State|PK parameters will be determined on PK profiles after the first dose and at steady-state using non-compartmental method(s) using WinNonlin|Cycle 1 - Day 1, 15; Cycle 2 - Day 15; Cycle 3 - Day 1, Day 15|Data were not collected|||||
658766|NCT01894672|Other Pre-specified|Overall Survival|Overall survival will be calculated for the start of treatment to the date of last death or follow-up.|1.5 years||03/2018||||
658767|NCT01894672|Secondary|Response Rate|Response rate (defined as complete + partial response) and 95% confidence interval will be estimated.|1.5 years|||percentage of participants||95% Confidence Interval|Number
658768|NCT01894672|Primary|Number of Participants With Response According to RECIST v1.1 Criteria|Efficacy for all patients will be evaluated by the study sites using RECIST v1.1 and response criteria based on contrast-enhanced CT. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Progression must also involve an increase in size of measurable lesions by at least 5 mm, to minimize the possibility that small changes in a small number of target lesions is falsely interpreted as progression.Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|1.5 years|||Participants|||Count of Participants
658769|NCT01894607|Secondary|Assess Image Quality of the Contrast Enhanced Ultrasound (CEUS)|Number of participants that show better image quality in terms of lesion conspicuity and enhancement following contrast injection vs. baseline.|1 day|1 participant was ineligible.||participants|||Number
658770|NCT01894607|Primary|Successful Capture of IO-CEUS Images|Primary objective is to determine feasibility of obtaining intraoperative (IO) contrast enhanced ultrasound (CEUS) images in participants undergoing open partial nephrectomy. Feasibility defined as the successful capture of IO-CEUS images in 8 out of 10 participants.|1 day|1 participant was ineligible.||participants|||Number
658771|NCT01894581|Primary|Change in the Average LH Pulse Amplitude|To test the pituitary and hypothalamic output, we examined LH secretion (unstimulated and in response to gonadotropin-releasing hormone (GnRH) stimulation) during 8-hour blood sampling studies at 10 min intervals. The primary outcome measure is the change in the average LH pulse amplitude for each patient from baseline to after supplementation.|10 minute intervals during 8 hour blood sampling studies. Subjects will undergo two menstrual cycles of study, one prior to dietary supplementation and one after supplementation.|||IU/L||Standard Deviation|Mean
658772|NCT01894555|Primary|Changes in Platelet Transcriptome|"Comparison of platelet transcriptome before aspirin therapy with platelet transcriptome after aspirin therapy.
The expression levels of genes before aspirin therapy was compared with the expression level of the genes after aspirin therapy. The expression levels were measured using the FPKM unit (Fragments Per Kilobase of transcript per Million mapped reads). The gene with the highest difference (pre vs. post) in FPKM is being reported with name in the units area and the actual difference in the number area"|4 weeks|The data were analyzed combining results from two studies (33 from this study and additional 24 individuals from study NCT02234427; total population size = 57) to improve the power to detect a difference. Same results are reported for the two studies. Note that the top most gene (HBG1) with the lowest p-value is being reported.||FPKM difference for HBG1 Gene||Standard Error|Mean
658773|NCT01894256|Other Pre-specified|CL/F of Unbound Olaparib|Calculated from dose divided by free AUC|Part A: Day 1, 1 hour post-dose|"Subset of PK analysis set with protein binding blood sample available. PK analysis set: All patients who receive an olaparib dose and have full PK sampling up to 96 hours post-dose.
Any patients with major protocol deviations that affected the evaluability of the PK profile were excluded."||L/hour||Standard Deviation|Median
658774|NCT01894256|Other Pre-specified|Free AUC of Olaparib|AUC of unbound olaparib; calculated by multiplying total AUC by estimated protein binding|Part A: Day 1, 1 hour post-dose|"Subset of PK analysis set with protein binding blood sample available. PK analysis set: All patients who receive an olaparib dose and have full PK sampling up to 96 hours post-dose.
Any patients with major protocol deviations that affected the evaluability of the PK profile were excluded."||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
658775|NCT01894256|Other Pre-specified|Free Cmax of Olaparib|Cmax of unbound olaparib; calculated by multiplying total Cmax value by estimated protein binding|Part A: Day 1, 1 hour post-dose|"Subset of PK analysis set with protein binding blood sample available. PK analysis set: All patients who receive an olaparib dose and have full PK sampling up to 96 hours post-dose.
Any patients with major protocol deviations that affected the evaluability of the PK profile were excluded."||μg/mL||Geometric Coefficient of Variation|Geometric Mean
658776|NCT01894256|Other Pre-specified|Protein Binding of Olaparib|Degree to which olaparib binds to the proteins within blood plasma|Part A: Day 1, 1 hour post-dose|"Subset of PK analysis set with protein binding blood sample available. PK analysis set: All patients who receive an olaparib dose and have full PK sampling up to 96 hours post-dose.
Any patients with major protocol deviations that affected the evaluability of the PK profile were excluded."||% plasma||Standard Deviation|Mean
658777|NCT01894256|Primary|t1/2 of Olaparib|Terminal half-life of olaparib|Part A: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose|"PK analysis set: All patients who receive an olaparib dose and have full PK sampling up to 96 hours post-dose.
Any patients with major protocol deviations that affected the evaluability of the PK profile were excluded."||Hours||Standard Deviation|Mean
661413|NCT01841567|Secondary|Pain Evaluation||7 days||||||
658779|NCT01894256|Primary|CL/F of Olaparib|Apparent plasma clearance of olaparib|Part A: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose|"PK analysis set: All patients who receive an olaparib dose and have full PK sampling up to 96 hours post-dose.
Any patients with major protocol deviations that affected the evaluability of the PK profile were excluded."||L/hour||Standard Deviation|Mean
658780|NCT01894256|Primary|Vz/F of Olaparib|Apparent volume of distribution of olaparib|Part A: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose|"PK analysis set: All patients who receive an olaparib dose and have full PK sampling up to 96 hours post-dose.
Any patients with major protocol deviations that affected the evaluability of the PK profile were excluded."||L||Standard Deviation|Mean
658781|NCT01894256|Primary|Tmax of Olaparib|Time to reach maximum plasma concentration of olaparib|Part A: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose|"PK analysis set: All patients who receive an olaparib dose and have full PK sampling up to 96 hours post-dose.
Any patients with major protocol deviations that affected the evaluability of the PK profile were excluded."||Hours||Full Range|Median
658782|NCT01894256|Primary|AUC0-t of Olaparib|Area under plasma concentration-time curve from zero to the last measurable time point of olaparib|Part A: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose|"PK analysis set: All patients who receive an olaparib dose and have full PK sampling up to 96 hours post-dose.
Any patients with major protocol deviations that affected the evaluability of the PK profile were excluded."||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
658783|NCT01894256|Primary|AUC of Olaparib|Area under plasma concentration-time curve from zero to infinity of olaparib|Part A: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose|"PK analysis set: All patients who receive an olaparib dose and have full PK sampling up to 96 hours post-dose.
Any patients with major protocol deviations that affected the evaluability of the PK profile were excluded."||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
658784|NCT01894256|Primary|Cmax of Olaparib|Maximum plasma drug concentration of olaparib|Part A: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose|"PK analysis set: All patients who receive an olaparib dose and have full PK sampling up to 96 hours post-dose.
Any patients with major protocol deviations that affected the evaluability of the PK profile were excluded."||μg/mL||Geometric Coefficient of Variation|Geometric Mean
658785|NCT01894230|Secondary|Beliefs About Medications (BMQ) Score at Baseline, Month 3 and Month 8|"Questionnaire administered at baseline, 3 months, and 8 months
This instrument assesses beliefs regarding necessity and concerns related to disease-specific medications
The score ranges from 5 to 25 representing the sum of 5 questions. This will be modeled with linear regression including treatment as predictor. Baseline BMQ scores will also be included as a covariate to account for baseline variability.
Higher score corresponds to higher thought necessity and higher thought concerns about taking the medication. The higher the necessity score, the more the patient believed statins necessary for their health. The higher the concerns score, the more the patient was concerned about taking stains (side effects)."|Baseline, Month 3, Month 8|Only subjects that completed the Beliefs About Medications questionnaire were included in the analysis.||units on a scale||Standard Deviation|Mean
658786|NCT01894230|Secondary|Physical Activity Scale Score|"Activity levels will be compared at the end of 8-months. Activity levels are defined by a five-level ordinal variable (0-4; higher level corresponding to higher activity). which was calculated based on survey answers. An ordinal logistic regression model will be used with arm as predictor. The assumption of proportional odds will be checked, and if it is not met, a multinomial regression model will be used. -Baseline physical activity will also be included as a covariate to account for baseline variability.
Scale score (0-4): 0 - Inactivity, 1 - Ligh-intensity activity, 2 - moderate-intensity activity, 3 - Hard-intensity activity, 5 - very hard-intensity activity"|Baseline and Month 8|Only subjects that completed the Physical Activity survey were included in the analysis||units on a scale||Standard Deviation|Mean
658787|NCT01894230|Secondary|Change in Short Form -12 Item (SF-12) Health Survey - Mental Component (MC)|"Month 3 and Month 8 SF12 scores for mental and physical health will be compared. Both of these measures will be modeled as a linear regression with arm as predictor. Baseline SF-12 scores will also be included as a covariate to account for baseline variability.
Ranges from 0 to 100, where a zero score indicates the lowest level of mental health measured by the scales and 100 indicates the highest level of mental health."|Baseline, Month 3, Month 8|Only subjects that completed the SF-12 Health Survey were included in the analysis.||units on a scale 0 to 100||Standard Deviation|Mean
658788|NCT01894230|Secondary|Change in Short Form -12 Item (SF-12) Health Survey - Physical Component (PC)|"Month 3 and Month 8 SF12 scores for mental and physical health will be compared. Both of these measures will be modeled as a linear regression with arm as predictor. Baseline SF-12 scores will also be included as a covariate to account for baseline variability.
Ranges from 0 to 100, where a zero score indicates the lowest level of physical health measured by the scales and 100 indicates the highest level of physical health"|Baseline, Month 3, Month 8|Only subjects that completed the SF-12 Health Survey were included in the analysis.||units on a scale||Standard Deviation|Mean
658789|NCT01894230|Secondary|Brief Pain Inventory (BPI) Score - Pain Interference at Month 3 and Month 8|"Brief Pain Inventory data will be taken from 3 and 8-month follow up Patient Surveys. -Pain severity and pain interference will be compared between groups -Both of these measures will be modeled as a linear regression with arm as predictor. Baseline pain scores will also be included as a covariate to account for baseline variability.
Scores range from 0-10. Higher scores indicate higher pain interference with daily activities."|Month 3 and Month 8|Only subjects that completed the Brief Pain Inventory surveys were included in the analysis.||units on a scale||Standard Deviation|Mean
658790|NCT01894230|Secondary|Brief Pain Inventory (BPI) Score - Pain Severity at Month 3 and Month 8|"Brief Pain Inventory data will be taken from 3 and 8-month follow up Patient Surveys. Pain severity and pain interference will be compared between groups. Both of these measures will be modeled as a linear regression with arm, genotype, and site as predictors. Transformations of the response may be explored depending on the distribution of the regression residuals. Baseline pain scores will also be included as a covariate to account for baseline variability.
Scores range from 0-10. Higher scores indicate higher pain severity."|Month 3 and Month 8|Only subjects that completed the Brief Pain Inventory surveys were included in the analysis.||units on a scale||Standard Deviation|Mean
661414|NCT01841567|Secondary|Comfort, Comformability, Acceptability of the Dressing||7 days||||||
658791|NCT01894230|Secondary|Number of Participants Reporting New Statin Prescriptions|The number of new prescriptions is binary and will be modeled with logistic regression with arm, genotype, and site as predictors. Any variables imbalanced between arms will also be included as covariates.|Baseline, Month 3, Month 8|Only subjects reporting new prescriptions were included in the analysis.||Participants|||Count of Participants
658792|NCT01894230|Secondary|Medication Possession Ratio (MPR) From Baseline to Last Patient Follow-up|Medication possession ratio will be calculated based on number of statin medication refills over time from randomization to end of follow up. MPR is calculated as follows: 1.Sum of the days' supply of all statin medications is the sum of the number of pills dispensed for each statin prescription during follow up (taken from 3-month, 4-month and 8-month statin utilization review) 2.Sum of the days of follow up = date of 8-month follow up survey - date of randomization 3.MPR = #1/#2 MPR will be modeled as a linear regression with arm, genotype, and site as predictors.|Baseline to Last patient follow-up in study (3 months or 8 months)|Only subjects who re-initiated statin medication and reported statin medication refills were included in the analysis.||ratio||Standard Deviation|Mean
658793|NCT01894230|Secondary|Low Density Lipoprotein Cholesterol (LDLc) at Baseline, Month 3 and Month 8|The continuous outcomes LDLc will be modeled as a linear regression with arm and baseline LDL as predictors.|Baseline, Month 3, Month 8|All subjects with available data were included in the analysis.||mg/dL||Standard Deviation|Mean
658794|NCT01894230|Primary|Morisky Medication Adherence Scale (MMAS) Score|The Morisky Medication Adherence Scale (MMAS) is a self-reported measure of adherence, collected at baseline for general medication and at 3 and 8 months of followup for statin specific adherence. The eight-item MMAS survey will be used. This is a modified version of the original four-item MMAS capturing further aspects of adherence behavior. The survey includes 8 yes/no items that are summed to create an overall adherence score ranging from of 0 to 8, with higher scores indicating better adherence. The primary hypothesis is that the genetically guided statin therapy leads to greater adherence of statin therapy, corresponding to a higher MMAS score.|3 months and 8 months|Only participants who re-initiated statin use were eligible to do statin specific MMAS and included in the analysis.||units on a scale||Standard Deviation|Mean
658795|NCT01894100|Secondary|Change in Lower Extremity Physical Function|For self-reported lower extremity physical function: Western Ontario and McMasters Universities Osteoarthritis Index physical function subscale. The physical function subscale includes 17 items that ask about difficulty with stair use, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy household duties, and light household duties. Participants rate each item on a scale of 0-4 (no difficulty to extreme difficulty. Totals scores for this subscale range from 0-68 (no difficulty to extreme difficulty).|Baseline and 3 months post intervention|||units on scale||Standard Deviation|Mean
658796|NCT01894100|Primary|Change in Pain Intensity|Western Ontario and McMasters Universities Osteoarthritis Index pain subscale is a 5 item questionnaire that asks participants to rate their pain during walking, using stairs, in bed, sitting or lying, and standing. Each item is rated by the participant as 0-4 (no pain to extreme pain). Total scores on the pain subscale range from 0 to 20 (no pain to extreme pain).|Baseline and 3 months after initiating intervention|||units on a scale||Standard Deviation|Mean
658797|NCT01894022|Secondary|Time to First Addition of Another Targeted PAH Therapeutic Agent Due to Deterioration of Clinical Condition or Lack of Beneficial Effect With Previous Therapy in Any Participant|"The time to addition of another targeted PAH therapeutic agents (prostanoids, PDE-5 inhibitors) due to the following reasons:
Deterioration of clinical condition; Lack of beneficial effect with previous therapy (not reaching set treatment goals). PAH therapies were collected, but after the study was terminated, not all endpoints listed in the protocol were analyzed, including time to first addition of another targeted PAH therapeutic agent. This decision was documented in the reporting and analysis plan prior to database lock."|From Entry visit of the extension study up to End of Study (assessed up to approximately 16 months)|Safety (Extension) Population.|||||
658798|NCT01894022|Secondary|Time to First Change in Dose of Open-label Ambrisentan Due to Deterioration of Clinical Conditions in Any Participant|The time to change in dose of ambrisentan or other targeted PAH therapeutic agents (prostanoids, PDE-5 inhibitors) due to deterioration of clinical condition. Dosing data were collected, but after the study was terminated, not all endpoints listed in the protocol were analyzed, including time to first change in dose of open-label ambrisentan. This decision was documented in the reporting and analysis plan prior to database lock.|From Entry visit of the extension study up to End of Study (assessed up to approximately 16 months)|Safety (Extension) Population|||||
658799|NCT01894022|Secondary|Percent Change From Start of Ambrisentan Treatment in Plasma N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP)|The NT-proBNP data in a previous outcome measure were also analyzed as change from start of ambrisentan treatment. The ratio to start of ambrisentan in NT-proBNP was calculated as the ratio of the value at the specified time-point to the start of ambrisentan value and was expressed as a percent change from start of ambrisentan. This was done by taking the mean change on the log scale, exponentiating, subtracting 1 and multiplying by 100. Standard deviation (SD) of the logged values (log[SD]) have been presented. As par. started to receive ambrisentan treatment in 2 studies, 2 different time points for start of ambrisentan treatment were used for this analysis. For par. who received ambrisentan treatment in study AMB115811, the Baseline for that study was used. For par. who received placebo in Study AMB115811, entry visit of the Extension study was defined as Baseline. Only those par. available at the specified time points were analyzed (represented by n=X, X in the category title).|Previous Placebo: Months 0 (Entry visit of the extension), 1, 3, 6, 9, 12; Previous Ambrisentan: Month 0 (Baseline of study AMB115811), 1, 2, 3, 4, Early Withdrawal (EW) (AMB115811), 5, 7, 10, 13, 16, 19; and at End of Study|ITT Population. Placebo arm: includes par. who received ambrisentan treatment during extension study||Percent change||Standard Deviation|Geometric Mean
658831|NCT01893411|Secondary|Occurrence of Participants With TEAEs of Special Interest (TEAESIs) Overall and Per Injection Cycle|Adverse Events (AE's) occurring after treatment that were thought to possibly indicate toxin spread throughout the trial conduct are defined as AE's of Special Interests. Values reported here refer to the number of participants affected.|Up to End of study visit (Week 24-72)|FAS population is subset in the SES for whom the primary efficacy variable (participants who had at least an AS score of plantar flexor at baseline [Day 1] or the investigator’s GICS-PF [for participants with bilateral treatment on same body side] at Day 29 [Week 4] of the first injection cycle) were available.||Participants|||Count of Participants
658800|NCT01894022|Secondary|Change From Start of Ambrisentan Treatment in Borg CR10 Scale (BCR10S) Immediately Following Exercise at the Indicated Time Points|The BCR10S data in a previous outcome measure were also analyzed as change from start of ambrisentan treatment. BCR10S score, a rating of perceived exertion, ranges from 0 to 10 (0=nothing at all, 10 extremely strong). If par.’s perception or feeling was stronger than “10”, a larger number could be used. As participants started to receive ambrisentan treatment in two studies, two different time points for start of ambrisentan treatment were used for this analysis. For participants who received ambrisentan treatment in Study AMB115811, the Baseline for that study was used. For participants who received placebo in Study AMB115811, entry visit of the Extension study was defined as Baseline. Change from start of ambrisentan was calculated as the value at the indicated visit minus the start of ambrisentan value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category title).|Previous Placebo: Months 0 (Entry visit of the extension), 1, 3, 6, 9, 12; Previous Ambrisentan: Month 0 (Baseline of study AMB115811), 1, 2, 3, 4, Early Withdrawal (EW) (AMB115811), 5, 7, 10, 13, 16, 19; and at End of Study|ITT Population. Placebo arm: includes par. who received ambrisentan treatment during extension study||Scores on a scale||Inter-Quartile Range|Median
658801|NCT01894022|Secondary|Change From Start of Ambrisentan Treatment in World Health Organization (WHO) Functional Class (FC) at the Indicated Time Points|The WHO functional class data in a previous outcome measure were also analyzed as change from start of ambrisentan treatment. There are 4 grades for WHO FC based on severity of symptoms of pulmonary arterial hypertension (Class I = none, Class IV = most severe). Grades mapped to numeric scale 1-4 (i.e. Class IV = 4). As participants started to receive ambrisentan treatment in two studies, two different time points for start of ambrisentan treatment were used for this analysis. For participants who received ambrisentan treatment in Study AMB115811, the Baseline for that study was used. For participants who received placebo in Study AMB115811, entry visit of the Extension study was defined as Baseline. Change from start of ambrisentan was calculated as the value at the indicated visit minus the start of ambrisentan value (positive change = worsening). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Previous Placebo: Months 0 (Entry visit of the extension), 1, 3, 6, 9, 12; Previous Ambrisentan: Month 0 (Baseline of study AMB115811), 1, 2, 3, 4, Early Withdrawal (EW) (AMB115811), 5, 7, 10, 13, 16, 19; and at End of Study|ITT Population. Placebo arm: includes par. who received ambrisentan treatment during extension study||Scores on a scale||Inter-Quartile Range|Median
658802|NCT01894022|Secondary|Change From Start of Ambrisentan Treatment in 6 Minutes Walking Distance at the Indicated Time Points|The 6 minute walk distance data in a previous outcome measure were also analyzed as change from start of ambrisentan treatment. As participants started to receive ambrisentan treatment in two studies, two different time points for start of ambrisentan treatment were used for this analysis. For participants who received ambrisentan treatment in Study AMB115811, the Baseline for that study was used. For participants who received placebo in Study AMB115811, entry visit of the Extension study was defined as Baseline. Change from start of ambrisentan was calculated as the value at the indicated visit minus the start of ambrisentan value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category title).|Previous Placebo: Months 0 (Entry visit of the extension), 1, 3, 6, 9, 12; Previous Ambrisentan: Month 0 (Baseline of study AMB115811), 1, 2, 3, 4, Early Withdrawal (EW) (AMB115811), 5, 7, 10, 13, 16, 19; and at End of Study|ITT Population. Placebo arm: includes par. who received ambrisentan treatment during extension study||Meters||Inter-Quartile Range|Median
658803|NCT01894022|Secondary|Percent Change From Study AMB115811 Baseline in Plasma N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP)|The ratio to Baseline in NT-proBNP was calculated as the ratio of the value at the specified time-point to the AMB115811 Baseline value and was expressed as a percent change from AMB115811 Baseline. This was done by taking the mean change on the log scale, exponentiating, subtracting 1 and multiplying by 100. Standard deviation (SD) of the logged values (log[SD]) have been presented. AMB115811 Baseline is the last value recorded on or prior to start of study treatment in that study. Participant's final visit in study AMB115811 was used as the entry visit of this open-label extension study. For the Extension study, the visit schedule (Months 1, 3, 6, 9, 12 and 15) was mapped to the visit schedule (Months 5, 7, 10, 13, 16 and 19) for continuity with study AMB115811. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). NA indicates that data were not available.|During Study AMB115811: Months 0 (Baseline), 1, 2, 3, 4, Early Withdrawal (EW); During Extension Study: Months 1, 3, 6, 9, 12, 15 and at End of Study (assessed up to approximately 20 months)|ITT Population||Percent change||Standard Deviation|Geometric Mean
658804|NCT01894022|Secondary|Change From Study AMB115811 Baseline in Quality of Life as Measured by Short Form 36 Health Survey (SF-36)|The SF-36 version 2 is a self-administered, health-related quality of life (QoL) metric. It is a 36-item questionnaire designed to measure 8 domains of functional health status and well-being: physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health as well as 2 summary measures (Physical Health and Mental Health). Each domain is scored from 0 (poorer health) to 100 (better health). Baseline of study AMB115811 was to be used. Change from study AMB115811 Baseline was to be calculated as the value at the indicated visit minus the Baseline value. The SF-36 data were collected, but after the study was terminated, not all endpoints listed in the protocol were analyzed, including the SF-36. This decision was documented in the reporting and analysis plan prior to database lock.|Baseline from study AMB115811 up to End of Study for the extension study (assessed up to approximately 20 months)|ITT Population|||||
658805|NCT01894022|Secondary|Number of Participants With Clinical Worsening of Chronic Thromboembolic Pulmonary Hypertension (CTEPH)|Time to clinical worsening of CTEPH was defined as the time from randomization in study AMB115811 to the first occurrence of any of the following events: death (all cause), lung transplantation, hospitalization for CTEPH deterioration, atrial septostomy, addition of parenteral prostanoids, appearance of two or more CTEPH worsening events. Worsening events included: >=20% of decrease in 6MWD; >=1 increase of WHO Functional Classes; worsening right ventricular failure; rapidly progressing cardiogenic, hepatic, or renal failure; refractory systolic hypotension (SBP <85 mmHg).|From randomization up to End of Study for the extension study (assessed up to approximately 20 months)|ITT Population||Participants|||Number
658806|NCT01894022|Secondary|Change From Study AMB115811 Baseline in Borg CR10 Scale (BCR10S) Immediately Following Exercise at the Indicated Time Points|"BCR10S score, a rating of perceived exertion, was collected immediately following completion of the 6-minute walk test. Scores range from 0 to 10 (0=nothing at all, 10=extremely strong). If par.'s perception or feeling was stronger than 10, that is “extremely strong”, “Maximal” –a larger number could be used, for example 12 or still higher, that is “Absolute maximum”). AMB115811 BL data was calculated as average of 2 BCR10S values obtained following the 2 6MWD tests used in determining the BL 6MWD in that study. If only 1 measurement was available, it was used. Change from AMB115811 BL was calculated as the value at the indicated visit minus the BL value. Par.'s final visit in AMB115811 was used as the entry visit of ext study. For the Ext study, the visit schedule (M1,3,6,9,12 and 15) mapped to the visit schedule (M5,7,10,13,16 and 19) for continuity with AMB115811. Only those par. available at the specified time points were analyzed (represented by n=X,X in the category titles)."|During Study AMB115811: Months (M) 0 (Baseline), 1, 2, 3, 4, Early Withdrawal (EW); During Extension (Ext) Study: Months 1, 3, 6, 9, 12, 15 and at End of Study (assessed up to approximately 20 months)|ITT Population||Scores on a scale||Inter-Quartile Range|Median
658807|NCT01894022|Secondary|Change From Study AMB115811 Baseline (BL) in World Health Organization (WHO) Functional Class (FC) at the Indicated Time Points|WHO FC indicates severity of pulmonary arterial hypertension (PAH) and is an adaptation of the New York Heart Association classification, assessed by the investigator. There are 4 grades for WHO FC based on severity of symptoms (Class I = none, Class IV = most severe). Grades mapped to numeric scale 1-4 (i.e. Class IV = 4). WHO FC system links symptoms with activity limitations, allowing clinicians to predict disease progression and prognosis. AMB115811 BL is the last value recorded on or prior to start of study treatment in that study. Change from AMB115811 BL was calculated as the value at the indicated visit minus the BL value (positive change = worsening). Par.'s final visit in AMB115811 was used as entry visit of this ext study. For Ext study, the visit schedule (M1,3,6,9,12 and 15) was mapped to the visit schedule (M5,7,10,13,16 and 19) for continuity with study AMB115811. Only par. available at the specified TP were analyzed (represented by n=X,X in the category title).|During Study AMB115811: Months (M) 0 (Baseline), 1, 2, 3, 4, Early Withdrawal (EW); During Extension (ext) Study: Months 1, 3, 6, 9, 12, 15 and at End of Study (assessed up to approximately 20 months)|ITT Population||Scores on a scale||Inter-Quartile Range|Median
658808|NCT01894022|Secondary|Change From Study AMB115811 Baseline in the 6 Minutes Walking Distance (6MWD) at the Indicated Time Points|The 6-minute walk test was conducted according to the American Thoracic Society guidelines in accordance with local standard operating procedures. 6MWD was measured by a 6-minute walk test. This test measures the distance that a par. can walk in a period of 6 minutes. AMB115811 Baseline was the Week 0 value in that study. Change from study AMB115811 Baseline was calculated as the value at the indicated visit minus the Baseline value. Par.'s final visit in study AMB115811 was used as the entry visit of this extension study. For the Extension study, the visit schedule (Months 1, 3, 6, 9, 12 and 15) was mapped to the visit schedule (Months 5, 7, 10, 13, 16 and 19) for continuity with study AMB115811. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Intent-to-treat (ITT) Population: all par. who were randomized and took at least one dose of study medication in the double-blind phase (placebo or ambrisentan).|During Study AMB115811: Months 0 (Baseline), 1, 2, 3, 4, Early Withdrawal (EW); During Extension Study: Months 1, 3, 6, 9, 12, 15 and at End of Study (assessed up to approximately 20 months)|ITT Population||Meters||Inter-Quartile Range|Median
658809|NCT01894022|Primary|Time to First Change in Dose of Open-label Ambrisentan Due to Tolerability Issues in Any Participant|The time to change in dose of ambrisentan or other targeted PAH (pulmonary arterial hypertension) therapeutic agents (prostanoids, PDE-5 inhibitors) due to tolerability issues (e.g. adverse events). Dosing data were collected, but after the study was terminated, not all endpoints listed in the protocol were analyzed, including time to first change in dose of open-label ambrisentan. This decision was documented in the reporting and analysis plan prior to database lock.|From the Entry visit of the extension study up to approximately 16 months|Safety (Extension) Population|||||
658810|NCT01894022|Primary|Change From Study AMB115811 Baseline in Weight at the Indicated Time Points|Weight was measured at Entry visit of the extension study, Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, and at end of study. Change from study AMB115811 Baseline in weight is summarized. AMB115811 Baseline is the last value recorded on or prior to start of study treatment in that study. Change from AMB115811 Baseline was calculated as the value at the indicated visit minus the Baseline value. Participant's final visit in study AMB115811 was used as the entry visit of this open-label extension study. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). NA indicates that data were not available.|Baseline from study AMB115811; Entry visit of the extension study; Months 1, 3, 6, 9, 12, 15; and End of Study (assessed up to approximately 16 months)|Safety (Extension) Population||kilogram (kg)||Inter-Quartile Range|Median
658811|NCT01894022|Primary|Change From Study AMB115811 Baseline in Heart Rate at the Indicated Time Points|Vital signs including heart rate were assessed at Entry visit of the extension study, Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, and end of study. Change from study AMB115811 Baseline in heart rate is summarized. AMB115811 Baseline is the last value recorded on or prior to start of study treatment in that study. Change from AMB115811 Baseline was calculated as the value at the indicated visit minus the Baseline value. Participant's final visit in study AMB115811 was used as the entry visit of this open-label extension study. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). NA indicates that data were not available|Baseline from study AMB115811; Entry visit of the extension study; Months 1, 3, 6, 9, 12, 15; and End of Study (assessed up to approximately 16 months)|Safety (Extension) Population||beats per minute||Inter-Quartile Range|Median
658832|NCT01893411|Secondary|Occurrence of Treatment Emergent Adverse Events (TEAEs) Overall and Per Injection Cycle|Treatment-emergent Adverse Events (TEAEs) are events observed from the time point of first injection until end of study visit (week 24-72). Values reported here refer to the number of participants affected.|Up to End of study visit (Week 24-72)|FAS population is subset in the SES for whom the primary efficacy variable (participants who had at least an AS score of plantar flexor at baseline [Day 1] or the investigator’s GICS-PF [for participants with bilateral treatment on same body side] at Day 29 [Week 4] of the first injection cycle) were available.||Participants|||Count of Participants
658812|NCT01894022|Primary|Change From Study AMB115811 Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Assessed at the Indicated Time Points|Vital signs including SBP and DBP were assessed at Entry visit of the extension study, Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, and end of study. Change from study AMB115811 Baseline in SBP and DBP is summarized. AMB115811 Baseline is the last value recorded on or prior to start of study treatment in that study. Change from AMB115811 Baseline was calculated as the value at the indicated visit minus the Baseline value. Participant's final visit in study AMB115811 was used as the entry visit of this open-label extension study. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). NA indicates that data were not available.|Baseline from study AMB115811; Entry visit of the extension study; Months 1, 3, 6, 9, 12, 15; and End of Study (assessed up to approximately 16 months)|Safety (Extension) Population||millimeter of mercury (mmHg)||Inter-Quartile Range|Median
658813|NCT01894022|Primary|Number of Participants With Creatinine Values of Potential Clinical Concern at Any Time Post Entry Visit|Blood samples were collected at Entry visit of the extension study, Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, and end of study plus any unscheduled lab tests for creatinine. A creatinine value of potential clinical concern high was defined as >=176.8 micromoles per Liter. Participants with both normal and high values were counted once under their worst case (high). Participant's final visit in study AMB115811 was used as the entry visit of this open-label extension study.|Entry visit of the extension study; Months 1, 3, 6, 9, 12, 15; and End of Study plus any unscheduled lab tests (assessed up to approximately 16 months)|Safety (Extension) Population||Participants|||Number
658814|NCT01894022|Primary|Number of Participants With Clinical Chemistry Parameters of Potential Clinical Concern at Any Time Post Entry Visit|Blood samples were collected post Entry visit of the extension study and up to end of study for evaluation of the clinical chemistry parameters of alanine amino transferase (ALT), aspartate amino transferase (AST), gamma glutamyl transferase (GGT), and total bilirubin. The clinical chemistry parameters of potential clinical concern high were defined as follows: ALT, AST, GGT >=3 times upper limit of normal (ULN); total bilirubin >=2 times ULN. Participants with both normal and high values were counted once under their worst case (high). Participant's final visit in study AMB115811 was used as the entry visit of this open-label extension study.|Post entry visit of the extension study and up to End of Study (assessed up to approximately 16 months)|Safety (Extension) Population||Participants|||Number
658815|NCT01894022|Primary|Change From Study AMB115811 Baseline in Red Blood Cell Count and Reticulocytes at the Indicated Time Points|Hematology parameters were assessed at Entry visit of the extension study, Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, and end of study. Change from study AMB115811 Baseline in red blood cell count and reticulocytes is summarized. AMB115811 Baseline is the last value recorded on or prior to start of study treatment in that study. Change from AMB115811 Baseline was calculated as the value at the indicated visit minus the Baseline value. Participant's final visit in study AMB115811 was used as the entry visit of this open-label extension study. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). NA indicates that data were not available.|Baseline from study AMB115811; Entry visit of the extension study; Months 1, 3, 6, 9, 12, 15; and End of Study (assessed up to approximately 16 months)|Safety (Extension) Population||Tera per Liter (TI/L)||Inter-Quartile Range|Median
658816|NCT01894022|Primary|Change From Study AMB115811 Baseline in Mean Corpuscle Volume at the Indicated Time Points|Hematology parameters were assessed at Entry visit of the extension study, Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, and end of study. Change from study AMB115811 Baseline in mean corpuscle volume is summarized. AMB115811 Baseline is the last value recorded on or prior to start of study treatment in that study. Change from AMB115811 Baseline was calculated as the value at the indicated visit minus the Baseline value. Participant's final visit in study AMB115811 was used as the entry visit of this open-label extension study. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). NA indicates that data were not available.|Baseline from study AMB115811; Entry visit of the extension study; Months 1, 3, 6, 9, 12, 15; and End of Study (assessed up to approximately 16 months)|Safety (Extension) Population||Femtoliter (fL)||Inter-Quartile Range|Median
658817|NCT01894022|Primary|Change From Study AMB115811 Baseline in Hematocrit at the Indicated Time Points|Hematology parameters were assessed at Entry visit of the extension study, Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, and end of study. Change from study AMB115811 Baseline in hematocrit is summarized. AMB115811 Baseline is the last value recorded on or prior to start of study treatment in that study. Change from AMB115811 Baseline was calculated as the value at the indicated visit minus the Baseline value. Participant's final visit in study AMB115811 was used as the entry visit of this open-label extension study. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). NA indicates that data were not available.|Baseline from study AMB115811; Entry visit of the extension study; Months 1, 3, 6, 9, 12, 15; and End of Study (assessed up to approximately 16 months)|Safety (Extension) Population||Ratio||Inter-Quartile Range|Median
658818|NCT01894022|Primary|Change From Study AMB115811 Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at the Indicated Time Points|Hematology parameters were assessed at Entry visit of the extension study, Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, and end of study. Change from study AMB115811 Baseline in hemoglobin and MCHC is summarized. AMB115811 Baseline is the last value recorded on or prior to start of study treatment in that study. Change from AMB115811 Baseline was calculated as the value at the indicated visit minus the Baseline value. Participant's final visit in Study AMB115811 was used as the entry visit of this open-label extension study. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). NA indicates that data were not available.|Baseline from study AMB115811; Entry visit of the extension study; Months 1, 3, 6, 9, 12, 15; and End of Study (assessed up to approximately 16 months)|Safety (Extension) Population||Grams per Liter (g/L)||Inter-Quartile Range|Median
658833|NCT01893411|Secondary|Time to Reinjection for Each of the Three Dose Groups for the First and Second Injection Cycle||Baseline up to Week 24-72|FAS population is subset in the SES for whom the primary efficacy variable (participants who had at least an AS score of plantar flexor at baseline [Day 1] or the investigator’s GICS-PF [for participants with bilateral treatment on same body side] at Day 29 [Week 4] of the first injection cycle) were available.||Weeks||Standard Deviation|Mean
658819|NCT01894022|Primary|Change From Study AMB115811 Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Absolute Neutrophil Count [ANC]), Platelet Count, and White Blood Cell (WBC) Count at the Indicated Time Points|Hematology parameters were assessed at Entry visit of the extension study, Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, and end of study. Change from study AMB115811 Baseline in basophils, eosinophils, lymphocytes, monocytes, total neutrophils (ANC), platelet count, and WBC count are summarized. AMB115811 Baseline is the last value recorded on or prior to start of study treatment in that study. Change from AMB115811 Baseline was calculated as the value at the indicated visit minus the Baseline value. Participant's final visit in Study AMB115811 was used as the entry visit of this open-label extension study. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). NA indicates that data were not available.|Baseline from study AMB115811; Entry visit of the extension study; Months 1, 3, 6, 9, 12, 15; and End of Study (assessed up to approximately 16 months)|Safety (Extension) Population||Giga per Liter (GI/L)||Inter-Quartile Range|Median
658820|NCT01894022|Primary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect. Refer to the general AE/SAE module for a list of AEs and SAEs. Participant's final visit in Study AMB115811 was used as the entry visit of this open-label extension study. Safety (Extension) Population: all participants who enrolled and took at least one dose of study treatment during the extension study.|From entry visit of the extension study up to approximately 16 months|Safety (Extension) Population||Participants|||Number
658821|NCT01893905|Primary|Change in Pain According to VAS (0-100 mm)|VAS=The visual analogue scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, the patients specify their condition by indicating a position along a continuous line between two end-points. In our case a 0-100 mm line was used to define the degree of pain. The change between baseline and each evaluation visit (week 4, week 12 and week 24) was calculated to evaluate the efficacy of the treatments (a negative number represents a decrease in pain).|24 weeks|||units on a scale||Standard Deviation|Mean
658822|NCT01893879|Primary|Number of Participants With Incidence of Lymphedema|Participants were evaluated every 3 months up to one year post lymph node dissection|Up to 1 year|||Participants|||Count of Participants
658823|NCT01893567|Secondary|Subject Reported Effectiveness Scores||2 weeks||||||
658824|NCT01893567|Secondary|Investigator Reported Effectiveness Scores||2 weeks||||||
658825|NCT01893567|Primary|Subject Reported Target Lesion Severity Score.|Subject reported mean scores of the target lesion numeric rating scale (TL-NRS; scale of 0 (no psoriasis) to 10 (very severe psoriasis)) at end of study.|2 weeks|||units on a scale||Standard Deviation|Mean
658826|NCT01893411|Secondary|Occurrence of TEAEs Leading to Discontinuation Overall and Per Injection Cycle|Treatment-emergent Adverse Events (TEASs) are events observed from the time point of first injection until end of study visit (week 24-72). Values reported here refer to the number of participants affected.|Up to End of study visit (Week 24-72)|FAS population is subset in the SES for whom the primary efficacy variable (participants who had at least an AS score of plantar flexor at baseline [Day 1] or the investigator’s GICS-PF [for participants with bilateral treatment on same body side] at Day 29 [Week 4] of the first injection cycle) were available.||Participants|||Count of Participants
658827|NCT01893411|Secondary|Occurrence of TEAEs by Final Outcome Overall and Per Injection Cycle|Treatment-emergent Adverse Events (TEAEs) are events observed from the time point of first injection until end of study visit (week 24-72). Values reported here refer to the number of participants affected.|Up to End of study visit (Week 24-72)|FAS population is subset in the SES for whom the primary efficacy variable (participants who had at least an AS score of plantar flexor at baseline [Day 1] or the investigator’s GICS-PF [for participants with bilateral treatment on same body side] at Day 29 [Week 4] of the first injection cycle) were available.||Participants|||Count of Participants
658828|NCT01893411|Secondary|Occurrence of TEAEs by Worst Intensity Overall and Per Injection Cycle|Treatment-emergent Adverse Events (TEAEs) are events observed from the time point of first injection until end of study visit (week 24-72). Values reported here refer to the number of participants affected.|Up to End of study visit (Week 24-72)|FAS population is subset in the SES for whom the primary efficacy variable (participants who had at least an AS score of plantar flexor at baseline [Day 1] or the investigator’s GICS-PF [for participants with bilateral treatment on same body side] at Day 29 [Week 4] of the first injection cycle) were available.||Participants|||Count of Participants
658829|NCT01893411|Secondary|Occurrence of TEAEs Related to Treatment as Assessed by the Investigator Overall and Per Injection Cycle|Treatment-emergent Adverse Events (TEAEs) are events observed from the time point of first injection until end of study visit (week 24-72). Values reported here refer to the number of participants affected.|Up to End of study visit (Week 24-72)|FAS population is subset in the SES for whom the primary efficacy variable (participants who had at least an AS score of plantar flexor at baseline [Day 1] or the investigator’s GICS-PF [for participants with bilateral treatment on same body side] at Day 29 [Week 4] of the first injection cycle) were available.||Participants|||Count of Participants
658830|NCT01893411|Secondary|Occurrence of Serious TEAEs (TESAEs) Overall and Per Injection Cycle|Treatment-emergent Serious Adverse Events (TESAEs) are events observed from the time point of first injection until end of study visit (week 24-72). Values reported here refer to the number of participants affected.|Up to End of study visit (Week 24-72)|FAS population is subset in the SES for whom the primary efficacy variable (participants who had at least an AS score of plantar flexor at baseline [Day 1] or the investigator’s GICS-PF [for participants with bilateral treatment on same body side] at Day 29 [Week 4] of the first injection cycle) were available.||Participants|||Count of Participants
658853|NCT01893203|Other Pre-specified|Adverse Reactions|Adverse reactions are evaluated by blinded observer at one week after treatment. A dermatologist will assess which side of the face or scalp presents a stronger reaction.|1 week|One week after the first photodynamic therapy (PDT), seven patients had more severe reactions (erythema, crusting) at the site treated with BF-200 ALA, five patients had more severe reactions at the MAL site and one patient showed no difference between sites.||participants|||Number
658834|NCT01893411|Secondary|Change in Scores of Pain Intensity (From Participants) and Pain Frequency (From Parent/Caregiver) to All Post Baseline Visits of the First and of the Second Injection Cycle|"The QPS is a patient-reported outcome for children and adolescents (2-17 years) with cerebral palsy on spasticity-related pain. Pain intensity (from participants) and pain frequency (from parent/caregiver) to be assessed with 'Questionnaire on Pain caused by Spasticity [QPS]'. The QPS Total Score for pain intensity ranges from 0 ('No Hurt') to 10 ('Hurt Worst'). The QPS Total Score for the observed pain frequency ranges from 0 (Never) to 4 (Always).
Values represent least square (LS) mean differences between baseline and the respective week (w) resulting from ANCOVA models comparing high versus low and in a second step mid versus low dose groups, respectively. Values for the low group may differ slightly depending on the comparison and are therefore provided separately for each comparison."|Baseline to Week 4, 8, and 12 of 1st IC and 2nd IC (Week 16-40, 20-44 and 24-48)|FAS population is subset in the SES for whom the primary efficacy variable (participants who had at least an AS score of plantar flexor at baseline [Day 1] or the investigator’s GICS-PF [for participants with bilateral treatment on same body side] at Day 29 [Week 4] of the first injection cycle) were available.||Units on a scale||Standard Error|Least Squares Mean
658835|NCT01893411|Secondary|Changes From Baseline in Gross Motor Function Measure [GMFM]-66 Score at the End of First Injection Cycle and at the End of Study Visit|"The GMFM-66 is a standardized observational 66-item instrument designed and validated to measure change in gross motor function over time in participants with cerebral palsy. Score values represent the total GMFM-66 score. Total GMFM scores range from 0 (worst) to 100 (best).
Values represent least square (LS) mean differences between baseline and the respective week (w) resulting from ANCOVA models comparing high versus low and in a second step mid versus low dose groups, respectively. Values for the low group may differ slightly depending on the comparison and are therefore provided separately for each comparison."|Baseline to Week 12-36 of 1st IC and 2nd IC (End of study = Week 24-72)|FAS population is subset in the SES for whom the primary efficacy variable (participants who had at least an AS score of plantar flexor at baseline [Day 1] or the investigator’s GICS-PF [for participants with bilateral treatment on same body side] at Day 29 [Week 4] of the first injection cycle) were available.||Units on a scale||Standard Error|Least Squares Mean
658836|NCT01893411|Secondary|Investigator's Global Impression of Change of GICS-Plantar-Flexor of Primary Body Side at Day 29 (Week 4) of the First and Second Injection Cycle|"The GICS are global outcomes to assess the impression of change due to treatment. GICS were assessed by the investigator, by the participant (if feasible) and by parents'/caregiver (if applicable). GICS are 7-Point Likert Scales ranging from +3 (very much improved function) to -3 (very much worse function). For participants with bilateral pes equinus, the body side for primary efficacy analysis i.e. “primary body side” was decided by investigator at screening and was kept throughout the entire study. For participants with unilateral treatment, the treated body side was kept throughout the entire study.
Values represent least square (LS) mean differences between baseline and the respective week (w) resulting from ANCOVA models comparing high versus low and in a second step mid versus low dose groups, respectively. Values for the low group may differ slightly depending on the comparison and are therefore provided separately for each comparison."|Baseline to Week 4 of 1st IC and 2nd IC (Week 16-40)|FAS population is subset in the SES for whom the primary efficacy variable (participants who had at least an AS score of plantar flexor at baseline [Day 1] or the investigator’s GICS-PF [for participants with bilateral treatment on same body side] at Day 29 [Week 4] of the first injection cycle) were available.||Units on a scale||Standard Error|Least Squares Mean
658837|NCT01893411|Secondary|Investigator's, Child's/Adolescent's, and Parent's/Caregiver's Global Impression of Change Scale [GICS] at Day 29 (Week 4) of the First and Second Injection Cycle|"The Global Impression of Change Scales (GICS) are global outcomes to assess the impression of change due to treatment. GICS were assessed by the investigator, by the participant (if feasible) and by parents'/caregiver (if applicable). GICS are 7-Point Likert Scales ranging from +3 (very much improved function) to -3 (very much worse function).
Values represent least square (LS) mean differences between baseline and the respective week (w) resulting from MMRM (Mixed Model Repeated Measurement) models comparing high versus low and in a second step mid versus low dose groups, respectively. Values for the low group may differ slightly depending on the comparison and are therefore provided separately for each comparison."|Baseline to Week 4 of 1st IC and 2nd IC (Week 16-40)|FAS population is subset in the SES for whom the primary efficacy variable (participants who had at least an AS score of plantar flexor at baseline [Day 1] or the investigator’s GICS-PF [for participants with bilateral treatment on same body side] at Day 29 [Week 4] of the first injection cycle) were available.||Units on a scale||Standard Error|Least Squares Mean
658838|NCT01893411|Secondary|Changes From Baseline in Modified Tardieu Scale [MTS] of Plantar Flexors of Primary Body Side at Day 29 (Week 4), Day 57 (Week 8), and Day 85 (Week 12) of the First and of the Second Injection Cycle|"The Modified Tardieu Scale (MTS) assesses spastic muscle tone by subtraction of two angles measured at different conditions of passive muscle stretch. R2 is the angle of passive range of motion with a passive movement at slow speed. R1 is the angle where a catch-and-release or clonus can be triggered at the fastest possible speed. Score values represent the measured (R2-R1) difference, i.e. the dynamic tone component of the examined muscle(s). Decreases of (R2-R1) represent reductions in the dynamic component of spasticity, i.e. improvement of dynamic muscle spasticity.
Values represent least square (LS) mean differences between baseline and the respective week (w) resulting from ANCOVA models comparing high versus low and in a second step mid versus low dose groups, respectively. Values for the low group may differ slightly depending on the model used for comparison and are therefore provided separately for each comparison."|Baseline to Week 4, 8, and 12 of 1st IC and 2nd IC (Week 16-40, 20-44 and 24-48)|FAS population is subset in the SES for whom the primary efficacy variable (participants who had at least an AS score of plantar flexor at baseline [Day 1] or the investigator’s GICS-PF [for participants with bilateral treatment on same body side] at Day 29 [Week 4] of the first injection cycle) were available.||Angle||Standard Error|Least Squares Mean
658854|NCT01893203|Secondary|Clinical Lesion Clearance|Clinical lesion clearance is observed by a blinded observer|3 months|||percentage of complete clearance|Participants|95% Confidence Interval|Number
658855|NCT01893203|Secondary|Pain|"Pain using visual analog scale (VAS 0-10, where 0 is no pain and 10 is the worst pain imaginable) on both treatment sides is assessed in every 30 minutes during 2-hour sun-exposure and afterwards once in two hours until 9 p.m.
(treatment day). Of these values, the mean maximal pain is assessed."|12 hours|Patients||units on a scale||Full Range|Mean
658839|NCT01893411|Secondary|Changes From Baseline in AS Score of Knee Flexors or Thigh Adductors in Participants With Unilateral Treatment at Day 29 (Week 4) of the First and of the Second Injection Cycle|"The Ashworth Scale (AS) is a well known and commonly used scale in clinical trials with spasticity. In spastic muscles the resistance to passive movement is assessed. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Values represent least square (LS) mean differences between baseline and the respective week (w) resulting from MMRM (Mixed Model Repeated Measurement) models comparing high versus low and in a second step mid versus low dose groups, respectively. Values for the low group may differ slightly depending on the comparison and are therefore provided separately for each comparison.
KF = Knee Flexors; TA = Thigh Adductors; w = week."|Baseline to Week 4 of 1st IC and 2nd IC (Week 16-40)|FAS population is subset in the SES for whom the primary efficacy variable (participants who had at least an AS score of plantar flexor at baseline [Day 1] or the investigator’s GICS-PF [for participants with bilateral treatment on same body side] at Day 29 [Week 4] of the first injection cycle) were available.||Units on a scale||Standard Error|Least Squares Mean
658840|NCT01893411|Secondary|Changes From Baseline in AS Score of Plantar Flexors of the Primary Body Side at Day 57 (Week 8) and Day 85 (Week 12) of the First and of the Second Injection Cycle|"The Ashworth Scale (AS) is a well known and commonly used scale in clinical trials with spasticity. In spastic muscles the resistance to passive movement is assessed. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). For participants with bilateral pes equinus, the body side for primary efficacy analysis i.e. “primary body side” was decided by investigator at screening and was kept throughout the entire study. For participants with unilateral treatment, the treated body side was kept throughout the entire study.
Values represent least square (LS) mean differences between baseline and the respective week (w) resulting from MMRM (Mixed Model Repeated Measurement) models comparing high versus low and in a second step mid versus low dose groups, respectively. Values for the low group may differ slightly depending on the comparison and are therefore provided separately for each comparison."|Baseline to Week 8 and 12 of 1st IC and 2nd IC (Week 20-44 and 24-48)|FAS population is subset in the SES for whom the primary efficacy variable (participants who had at least an AS score of plantar flexor at baseline [Day 1] or the investigator’s GICS-PF [for participants with bilateral treatment on same body side] at Day 29 [Week 4] of the first injection cycle) were available.||Units on a scale||Standard Error|Least Squares Mean
658841|NCT01893411|Secondary|Change From Baseline in the AS Score of Plantar Flexors of the Primary Body Side at Day 29 (Week 4) of the Second Injection Cycle|"The Ashworth Scale (AS) is a well known and commonly used scale in clinical trials with spasticity. In spastic muscles the resistance to passive movement is assessed. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). For participants with bilateral pes equinus, the body side for primary efficacy analysis i.e. “primary body side” was decided by investigator at screening and was kept throughout the entire study. For participants with unilateral treatment, the treated body side was kept throughout the entire study.
Values represent least square (LS) mean differences between baseline and Week 16-40 resulting from MMRM (Mixed Model Repeated Measurement) models comparing high versus low and in a second step mid versus low dose groups, respectively. Values for the low group may differ slightly depending on the comparison and are therefore provided separately for each comparison."|Baseline to Week 4 of 2nd IC (Week 16-40)|FAS population is subset in the SES for whom the primary efficacy variable (participants who had at least an AS score of plantar flexor at baseline [Day 1] or the investigator’s GICS-PF [for participants with bilateral treatment on same body side] at Day 29 [Week 4] of the first injection cycle) were available.||Units on a scale||Standard Error|Least Squares Mean
658842|NCT01893411|Secondary|Change From Baseline in the AS Score of Plantar Flexors of the Nonprimary Body Side in Participants With Bilateral Treatment at Day 29 (Week 4) of the First (1st) and Second Injection Cycle (2nd IC)|"The Ashworth Scale (AS) is a well known and commonly used scale in clinical trials with spasticity. In spastic muscles the resistance to passive movement is assessed. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Values represent least square (LS) mean differences between baseline and the respective week (w) resulting from MMRM (Mixed Model Repeated Measurement) models comparing high versus low and in a second step mid versus low dose groups, respectively. Values for the low group may differ slightly depending on the comparison and are therefore provided separately for each comparison."|Baseline, Week 4 of 1st IC and Week 16-40 of 2nd IC|FAS population is subset in the SES for whom the primary efficacy variable (participants who had at least an AS score of plantar flexor at baseline [Day 1] or the investigator’s GICS-PF [for participants with bilateral treatment on same body side] at Day 29 [Week 4] of the first injection cycle) were available.||Units on a scale||Standard Error|Least Squares Mean
658843|NCT01893411|Primary|Co-primary Variable: Investigator's Global Impression of Change of Plantar Flexor Spasticity Scale (GICS-PF) of the Primary Body Side at Day 29 (Week 4) of the First Injection Cycle|"This variable is classified as co-primary to satisfy a Food and Drug Administration (FDA) request. The GICS-PF scale is a 7-Point Likert Scale for the assessment of the functional change due to treatment of plantar flexor spasticity only. Ranges from +3 (very much improved function) to -3 (very much worse function). For participants with bilateral pes equinus, the body side for primary efficacy analysis i.e. “primary body side” was decided by investigator at screening and was kept throughout the entire study. For participants with unilateral treatment, the treated body side was kept throughout the entire study.
Values represent least square (LS) mean differences between baseline and Week 4 resulting from ANCOVA models comparing high versus low and in a second step mid versus low dose groups, respectively. Values for the low group may differ slightly depending on the comparison and are therefore provided separately for each comparison."|Baseline, Week 4|FAS population is subset in the SES for whom the primary efficacy variable (participants who had at least an AS score of plantar flexor at baseline [Day 1] or the investigator’s GICS-PF [for participants with bilateral treatment on same body side] at Day 29 [Week 4] of the first injection cycle) were available.||Units on a scale||Standard Error|Least Squares Mean
658866|NCT01892267|Secondary|Direct Cost|Cost will be determined according to Medicare reimbursement of billed CPT codes. The cost of all related follow-up procedures will be included (e.g. cost of standard PEGJ in case of failed Self-propelled PEGJ feeding tube, cost of managing complications, cost of re-intervention in case of tube dysfunction, etc)|2 years|Study terminated prematurely, so that the appropriate follow-up data was not collected.|||||
658844|NCT01893411|Primary|Change From Baseline in the Ashworth Scale (AS) Score of Plantar Flexors of the Primary Body Side at Day 29 (Week 4) of the First Injection Cycle (1st IC)|"The Ashworth Scale (AS) is a well known and commonly used scale in clinical trials with spasticity. In spastic muscles the resistance to passive movement is assessed. It is a 5-point scale that ranges from 0 (= no increase in tone) to 4 (=limb rigid in flexion or extension). For participants with bilateral pes equinus, the body side for primary efficacy analysis i.e. “primary body side” was decided by investigator at screening and was kept throughout the entire study. For participants with unilateral treatment, the treated body side was kept throughout the entire study.
Values represent least square (LS) mean differences between baseline and Week 4 resulting from MMRM (Mixed Model Repeated Measurement) models comparing high versus low and in a second step mid versus low dose groups, respectively. Values for the low group may differ slightly depending on the comparison and are therefore provided separately for each comparison."|Baseline, Week 4|FAS population is subset in the SES for whom primary efficacy variable (participants who had at least an AS score of plantar flexor at baseline [Day 1] or investigator’s Global Impression of Change of Plantar Flexor Spasticity Scale (GICS-PF) [participants with bilateral treatment on same body side] at Day 29 [Week 4] of the 1st IC) were available.||Units on a scale||Standard Error|Least Squares Mean
658845|NCT01893359|Primary|MRSE Regression|The co-primary efficacy endpoints are a comparison of MRSE regression in the refractive outcome between the LASIK only eyes and the LASIK with cross-linking eyes within each treatment type and duration (2 minutes continuous UVA or 3 minutes pulsed UVA cross-linking) expressed as the change between one week and six months, and one week and twelve months.|one week to twelve months|This trial had extremely low enrollment due to difficulties recruiting patients therefore no analysis was conducted.|||||
658846|NCT01893359|Primary|MRSE Regression|The co-primary efficacy endpoints are a comparison of MRSE regression in the refractive outcome between the LASIK only eyes and the LASIK with cross-linking eyes within each treatment type and duration (2 minutes continuous UVA or 3 minutes pulsed UVA cross-linking) expressed as the change between one week and six months, and one week and twelve months.|one week to six months|This trial had extremely low enrollment due to difficulties recruiting patients therefore no analysis was conducted. Data for MSRE were collected for the two treated patients the primary endpoint is a comparison between the treatment groups. The two patients were in the same treatment group so a comparison between groups is not possible.|||||
658847|NCT01893346|Primary|Pharmacokinetic Parameters of Avibactam and Ceftazidime for Cohort 1 and 2: Cmax|Key PK parameters are shown for cohorts 1 and 2. For cohorts 3 and 4 (where children were <6 years of age), sparse sampling scheme was used for PK samples to limit the volume of blood required. PK parameters cannot be derived from these sparse PK samples without population PK analysis. Thus the PK is not described here, but will be reported in a separate population PK report.|Day 1|Pharmacokinetic analysis set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
658848|NCT01893346|Primary|Pharmacokinetic Parameters of Avibactam and Ceftazidime for Cohort 1 and 2: AUC|Key PK parameters were prespecified to be calculated for cohorts 1 and 2. For cohorts 3 and 4 (where children were <6 years of age), sparse sampling scheme was used for PK samples to limit the volume of blood required. PK parameters cannot be derived from these sparse PK samples without population PK analysis. Thus the PK is not described here, but will be reported in a separate population PK report.|Day 1|Pharmacokinetic analysis set||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
658849|NCT01893281|Secondary|Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level|"PGI-I for energy level is a participant-rated questionnaire that measures change in energy level after a participant begins the study drug. The questionnaire was completed at every visit post baseline using a 7-point scale where a score of 1 indicated that the participant's energy level was very much better, a score of 4 indicated that the participant had experienced no change in energy level and a score of 7 indicated that the participant's energy level was very much worse. Percentage of participants = (number of participants in the category) / (total number of participants who responded to the questionnaires) * 100."|Study Days 15, 22, 36, 43, 57, 64 and endpoint|All enrolled participants who received at least 1 dose of study drug and responded to PGI-I energy level questionnaire at specified time points. Endpoint is defined as the last non-missing PGI-I scale for energy level collected from Day 15 through end of study.||percentage of participants|||Number
658850|NCT01893281|Secondary|Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive|PGI-I for sexual drive is a participant-rated questionnaire that measure change in sexual drive after a participant begins the study drug. The questionnaire was completed at every visit post baseline using a 7-point scale where a score of 1 indicated that the participant's sexual drive was “very much better,” a score of 4 indicated that the participant had experienced “no change” in sexual drive and a score of 7 indicated that the participant's sexual drive was “very much worse”. Percentage of participants = (number of participants in the category) / (total number of participants who responded to the questionnaire) * 100.|Study Days 15, 22, 36, 43, 57, 64 and endpoint|All enrolled participants who received at least 1 dose of study drug and responded to PGI-I sexual drive questionnaire at specified time points. Endpoint is defined as the last non-missing PGI-I scale for sexual drive collected from Day 15 through end of study.||percentage of participants|||Number
658851|NCT01893281|Secondary|Change From Baseline in Serum Testosterone Levels|Serum testosterone levels were measured by LC/MS-MS.|Baseline, Study Completion (Up to 9 Weeks)|All enrolled participants who received at least 1 dose of study drug with non-missing data at baseline and at least 1 post baseline measurement. Last-observation-carried-forward (LOCF) was used to impute missing data.||ng/dL||Standard Deviation|Mean
658852|NCT01893281|Primary|Percentage of Participants Achieving Normal Serum Testosterone Levels|Normal serum testosterone level is defined as ≥300 to ≤1050 nanograms/deciliter (ng/dL). Serum testosterone levels were measured by liquid chromatography and tandem mass spectrometry (LC/MS-MS). Percentage of participants = (number of participants who achieved normal serum testosterone level) / (number of treated participants who had serum testosterone level measured) * 100.|Baseline through Study Completion (Up to 9 Weeks)|All enrolled participants who received at least 1 dose of study drug and had serum testosterone level measurement.||percentage of participants||95% Confidence Interval|Number
658856|NCT01893203|Primary|Histological Lesion Clearance|Punch biopsies were taken symmetrically on both treatment fields from equally graded >6 mm AKs prior to treatment and again at 3 months, blinded observer (pathologist). HE- and p53-stainings. Samples not fulfilling the criteria of an AK were defined as healthy or completely cleared. The p53 reactivity expressed as average percentage of positive nuclei in three consecutive high power fields from the region of highest reactivity (<10 % normal)|0 (baseline) and 3 months|Punch biopsies bilaterally on treatment fields||percentage of complete clearance|||Number
658857|NCT01892657|Primary|Area of Erythema and Elevated Responses of Skin to Product|Subjects were patched 9 times at 48 hour to 72 hour intervals and graded for erythema and elevated responses (edema, papules, vesicles, bullae) on a 4 point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe). 12 to 24 hours after the last patch application, a challenge patch was applied at the same site and a challenge patch was applied to an alternate site. Both were graded for the same criteria at 48 hours and at 96 hours. A total of 11 patches were applied to each subject. All patches were removed after 48 hours.|3 consecutive weeks|||participants|||Number
658858|NCT01892306|Other Pre-specified|Association Between Change on Depression (HAM-D) and Baseline Resting State Functional Connectivity of Anterior Insula and Ventrolateral Prefrontal Cortex|Resting state functional magnetic resonance imaging (rsfMRI) data (non-task, eyes opened) was acquired to investigate anterior insula and ventrolateral prefrontal cortex functional connectivity as a predictor of change on depression (HAM-D). See primary outcome description of HAM-D.|Six Months|Participating in the fMRI portion of the study was optional. A total of 15 participants consented to participate in fMRI portion (7 TAU+UP, 8 TAU). Data from all 15 subjects were analyzed.||beta coefficient||Standard Error|Mean
658859|NCT01892306|Secondary|Association Between Anxiety Symptom Change (HAM-A) and Neuroticism (NEO Five-Factor Inventory- NEO-FFI-N)|Neuroticism was assessed using the NEO Five Factor Inventory (NEO-FFI-N) which is a subscale of the NEO-FFI, a 60-item Likert-type scale (1-5) calculated by summing scores for each subscale. Only the 15-item Neuroticism subscale is included in this study. See Baseline Characteristics for baseline NEO-FFI-N. See Primary Outcome Measure for description of HAM-A.|6 months|ITT analysis, data imputed to account for 30% missing data. A total of 28 people were included in the ITT analysis - one TAU participant initiated CBT through a private practitioner mid-study (an exclusion criteria) and was subsequently excluded from the analysis.||beta coefficients||Standard Error|Mean
658860|NCT01892306|Secondary|Association Between Anxiety Symptom Change (HAM-A) and Anxiety Sensitivity (Anxiety Sensitivity Index-ASI)|Anxiety sensitivity, were assessed using the Anxiety Sensitivity Index, or ASI, a 16-item Likert-type scale (0-4) calculated by summing scores across items. See Baseline Characteristics for baseline ASI scores. See Primary Outcome Measures for a description of HAM-A.|6 months|ITT analysis, data imputed to account for 30% missing data. A total of 28 people were included in the ITT analysis - one TAU participant initiated CBT through a private practitioner mid-study (an exclusion criteria) and was subsequently excluded from the analysis.||beta coefficients||Standard Error|Mean
658861|NCT01892306|Secondary|Association Between Anxiety Symptom Change (HAM-A) and Reaction to Emotions (Affective Control Scale-ACS)|Reactions to emotions, were assessed using the Affective Control Scale, or ACS, a 42-item Likert-type scale (1-7) calculated by averaging scores across all items. See Baseline Characteristics for baseline ACS score. See Primary Outcome Measure for description of HAM-A.|6 months|ITT analysis, data imputed to account for 30% missing data. A total of 28 people were included in the ITT analysis - one TAU participant initiated CBT through a private practitioner mid-study (an exclusion criteria) and was subsequently excluded from the analysis.||beta coefficients||Standard Error|Mean
658862|NCT01892306|Secondary|Association Between Anxiety Symptom Change (HAM-A) and Difficulties in Emotion Regulation Scale (DERS)|Emotion regulation skills were assessed using a measure of emotion regulation (Difficulties in Emotion Regulation Scale- DERS), a 36-item Likert-type scale (1-6) calculated by averaging scores across all items. See Baseline Characteristics for baseline DERS score. See Primary Outcome Measure for a description of HAM-A.|Six Months|ITT analysis, data imputed to account for 30% missing data. A total of 28 people were included in the ITT analysis - one TAU participant initiated CBT through a private practitioner mid-study (an exclusion criteria) and was subsequently excluded from the analysis.||beta coefficients||Standard Error|Mean
658863|NCT01892306|Secondary|Treatment Acceptability as Measured by Client Satisfaction Questionnaire (CSQ)|The Client Satisfaction Questionnaire (CSQ) is an 8-item scale that assesses perceptions of acceptability and quality of outpatient treatment. Ratings are made on a 1 (poor) to 4 (excellent) scale for each item and then summed for a total score, with a minimum score of 8 and a maximum score of 32. Higher scores indicate greater satisfaction with treatment.|Six months|ITT analysis, data imputed to account for 30% missing data. A total of 28 people were included in the ITT analysis - one TAU participant initiated CBT through a private practitioner mid-study (an exclusion criteria) and was subsequently excluded from the analysis.||Units on scale||Standard Deviation|Mean
658864|NCT01892306|Primary|Reductions Over Time in Depression Symptoms as Measured by Hamilton Depression Rating Scale (HAM-D)|The Hamilton Depression Rating Scale (HAM-D) is a well-validated clinician administered rating of depression-related symptoms. Scores are calculated by summing scores across all 17-items, with a minimum score of 0 and a maximum score of 54. Higher scores indicate greater impairment.|Six months|ITT analysis, data imputed to account for 30% missing data. A total of 28 people were included in the ITT analysis - one TAU participant initiated CBT through a private practitioner mid-study (an exclusion criteria) and was subsequently excluded from the analysis.||Units on scale||Standard Deviation|Mean
658865|NCT01892306|Primary|Reductions Over Time in Anxiety Symptoms as Measured by Hamilton Anxiety Rating Scale|The Hamilton Anxiety Rating Scale (HAM-A) is a well-validated clinician administered rating of anxiety-related symptoms. Ratings are made on a 0 (no symptoms) to 4 (most severe in frequency/duration/interference/distress) for each item (14 items), with a minimum score of 0 and a maximum score of 56 calculated by summing scores of all 14 items. Higher scores indicate greater impairment.|Six months|ITT analysis, data imputed to account for 30% missing data. A total of 28 people were included in the ITT analysis - one TAU participant initiated CBT through a private practitioner mid-study (an exclusion criteria) and was subsequently excluded from the analysis.||Units on scale||Standard Deviation|Mean
658867|NCT01892267|Secondary|Long-term Complications|Long-term complications will include stomal (Infection, erythema, bleeding, pain, secretion, abscess, etc) and tube (Clotting, dislocation, defect and aspiration, etc) complications detected more than one week after intervention.|2 years|Study terminated prematurely, so that the appropriate follow-up data was not collected.|||||
658869|NCT01892267|Secondary|Gastrointestinal Quality of Life Index (GIQLI) Score|Gastrointestinal Quality of Life Index (GIQLI) score ranging from 0 (worst quality of life possible with severe digestive symptoms) to 144 (optimal quality of life without symptoms|3 month|The discrepancy between the number of analyzed patients and the number of patients in the Participant Flow section is due to the fact that only 5 patients had a completed GIQLI questionnaire at 3-month follow-up.||units on a scale||Full Range|Median
658870|NCT01892267|Secondary|Difficulty of the Procedure|"Scored by the endoscopist on a 10-point Visual Analogue Scale with zero being without difficulty and 10 being maximum difficulty.
The lower the score, the better the outcome."|Inra-procedural|||units on a scale||Standard Deviation|Mean
658871|NCT01892267|Secondary|Time to Repeat Endoscopy for Tube Replacement|If repeate endocopy and tube placement are needed due to clogging or retrograde migration|2 years|Study terminated prematurely, so that the appropriate follow-up data was not collected.|||||
658872|NCT01892267|Secondary|Intervention Time|Time required from introduction of the upper endoscope until placement of the feeding tube.|Intra-procedural|||minute||Standard Deviation|Mean
658873|NCT01892267|Secondary|Technical Success|Success of tube placement in the desired location as determined endoscopically.|Intra-procedural|||procedure|||Number
658874|NCT01892267|Secondary|Patency of Feeding Tube|Determine tube patency which is defined as time period between tube placement and need for re-intervention.|2 years|Study terminated prematurely, so that the appropriate follow-up data was not collected.|||||
658875|NCT01892267|Secondary|Repeat Endoscopy for Feeding Tube Placement Due to Retrograde Tube Migration|Patiens who will have retrograde PEG-J tube migration will get repeat endoscopy for PEG-J tube placement|4 weeks|||participants|||Number
658876|NCT01892267|Primary|Number of Participants With PEG-J Tube Migration|Number of participants in whom migration was assessed by X-ray at 4 weeks post-intervention.|From date of placement up to 4 weeks|||participants|||Number
658877|NCT01892189|Secondary|Percentage of Participants Who Meet the TGRD Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters at Least Once Post Dose|The percentage of participants who meet markedly abnormal criteria designated by TGRD measured throughout study.|Baseline up to 14 days after last dose of study drug (Day 32)|Safety analysis set included all participants who received at least 1 dose of study drug.||percentage of participants|||Number
658878|NCT01892189|Secondary|Percentage of Participants Who Meet the TGRD Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose|The percentage of participants who meet markedly abnormal criteria designated by TGRD. Vital signs included oral temperature, respiration, blood pressure and pulse (beats per minute).|Baseline up to 14 days after last dose of study drug (Day 32)|Safety analysis set included all participants who received at least 1 dose of study drug.||percentage of participants|||Number
658879|NCT01892189|Secondary|Percentage of Participants Who Meet the Takeda Global Research and Development Center, Inc. (TGRD) Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose|The percentage of participants with any markedly abnormal standard safety laboratory values collected throughout study.|Baseline up to 14 days after last dose of study drug (Day 32)|Safety analysis set included all participants who received at least 1 dose of study drug.||percentage of participants|||Number
658880|NCT01892189|Secondary|Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)||Baseline up to 14 days after last dose of study drug (Day 32)|Safety analysis set included all participants who received at least 1 dose of study drug.||percentage of participants|||Number
658881|NCT01892189|Secondary|AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-063 and TAK-063 M-I||Day 1: Pre-dose and at multiple time points (up to 24 hours) post-dose|The PK analysis set included all participants in the safety set and with at least 1 measurable plasma concentration. PK analysis set did not include 2 participants treated with 300 mg.||nanogram hours per milliliter (ng*hr/mL)||Standard Deviation|Mean
658882|NCT01892189|Secondary|Tmax: Time to Reach Cmax for TAK-063 and TAK-063 M-I||Day 1: pre-dose and at multiple time points (up to 24 hours) postdose|The PK analysis set included all participants in the safety set and with at least 1 measurable plasma concentration. PK analysis set did not include 2 participants treated with 300 mg.||hours||Full Range|Median
658883|NCT01892189|Secondary|Cmax: Maximum Observed Plasma Concentration for TAK-063 and TAK-063 Metabolite (M-I)||Day 1: pre-dose and at multiple time points (up to 24 hours) postdose|The pharmacokinetic (PK) analysis set included all participants in the safety set and with at least 1 measurable plasma concentration. PK analysis set did not include 2 participants treated with 300 mg.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
658884|NCT01892189|Primary|Ketamine-Induced Brain Activity in Regions of Interest During Resting State|Ketamine model was used to enhance the sensitivity to detect an effect of phosphodiesterase 10a (PDE10a) inhibition by TAK-063 by ketamine using neuroimaging battery tests. Ketamine induced robust blood oxygen level-dependent(BOLD) functional magnetic resonance imaging(fMRI) response while maintaining minimal accompanying psychotomimetic symptoms. The regions of interest include:left anterior cingulate cortex,right anterior cingulate cortex,left posterior cingulate cortex,right posterior cingulate cortex,left striatum,right striatum,left amygdala,right amygdala,left substantia nigra,right substantia nigra,left thalamus,right thalamus,left ventrolateral prefrontal cortex,right ventrolateral prefrontal cortex,left dorsolateral prefrontal cortex,right dorsolateral prefrontal cortex,left hippocampus,right hippocampus,left subgenual cingulate/Ba25,right subgenual cingulate/Ba25,left paracingulate gyrus/Ba32, and right paracingulate gyrus/Ba32.|Day 1: 4 hours post TAK-063 dose or placebo|The pharmacodynamic (PD) analysis set included all participants in the safety set and with at least 1 valid PD assessment. PD analysis set did not include 2 participants treated with TAK-063 300 mg.||percent signal change in brain activity||Standard Deviation|Mean
658885|NCT01892163|Secondary|Proportion of Patients With Ocular and Systemic Serious Adverse Events||12 months|||participants|||Number
658886|NCT01892163|Secondary|Difference Between Arms in Change in Central Subfield Thickness.|Central subfield thickness is defined as the average thickness in the central 1mm diameter circle of the ETDRS grid and is measured in microns|Baseline and 12 months|Few patients in both groups developed cataract. Due to the dense cataract, it was not possible to obtain the macular scans. Hence the discrepancy between the population who completed the study and the number for whom the OCT was obtained at exit visit.||microns||Standard Deviation|Mean
658887|NCT01892163|Secondary|Difference Between Arms in Change From Baseline Composite Scores of the National Eye Institute Visual Function Questionnaire (VFQ-25).|"NEI VFQ 25 is a questionnaire intended to measure visual function and quality of life. It has 25 questions. The original response of each item are coded as per the NEI VFQ scoring system ranging from 0 (lowest) to 100 (highest).
Composite score = (Score for each item with a non-missing answer) / Total number of items with non-missing answers 100 = Best, 0 = Worst possible score"|Baseline and 12 months|Though 48 patients completed the trial in the PRN arm, one patient did not complete the questionnaire completely, making it invalid for analysis. Hence the PRN arm number for this outcome was 47||units on a scale||Standard Deviation|Mean
658888|NCT01892163|Primary|The Difference Between Arms in the Change From Baseline in Best Corrected Visual Acuity at 12 Months||Baseline and 12 months|Intention to treat analysis (available case)||ETDRS letters||Standard Deviation|Mean
658889|NCT01892020|Secondary|Incidence of AEs (Adverse Event)|Treatment emergent AE (TEAE) is defined as an event that has onset date on or after the first day of exposure to randomized treatment and no later than the last day of randomized treatment.|During 4 weeks of treatment in each treatment sequence|Safety analysis set included all subjects receiving at least one dose of investigational products.||Events/100 years of patient exposure|||Number
658890|NCT01892020|Secondary|Incidence of Hypoglycemic Episodes|Treatment Emergent Hypoglycemic Episode refers to those the onset of the episode is on or after the first day of exposure to randomized treatment and no later than the last day of randomized treatment. Results are presented by American Diabetes Association classification of hypoglycemia.|During 4 weeks of treatment in each treatment sequence|Safety analysis set included all subjects receiving at least one dose of investigational products.||events per patient per year|||Number
658891|NCT01892020|Secondary|The Mean 2-hour PPG Increments of the 3 Main Meals in 8-point SMPG Profile|Mean post prandial PG increment over all meals was derived as the mean of all available meal increments.|After 4 weeks of treatment in each treatment sequence|Of the 161 randomized subjects, 155 subjects received BIAsp 50 and 158 subjects received BHI 50 (152 subjects received both, 3 subjects only received BIAsp 50 and 6 subjects only received BHI 50). Four (4) subjects in BIAsp 50 group and 9 subjects in BHI 50 group did not contribute to the analysis due to lack of post-randomization measurements.||mmol/L||Standard Error|Least Squares Mean
658892|NCT01892020|Secondary|2-hour PPG Increments Over Each of the 3 Main Meals in 8-point SMPG (Self-measured Plasma Glucose) Profile|PPG increments over each of the 3 main meals were derived from the 8-point SMPG profile as the difference between PG values available 120 minutes after meal and before meal.|After 4 weeks of treatment in each treatment sequence|Of the 161 randomized subjects, 155 subjects received BIAsp 50 and 158 subjects received BHI 50 (152 subjects received both, 3 subjects only received BIAsp 50 and 6 subjects only received BHI 50). Subjects were excluded from analysis due to lack of post-randomization measurements. See table.||mmol/L||Standard Error|Least Squares Mean
658893|NCT01892020|Secondary|­IAUC (Incremental Area Under the Curve) for PPG (0-2 Hours) Following a Standard Meal Test|AUC for plasma glucose was calculated by the trapezoidal method using 30-min sampling time points, and IAUC for PPG (0-2h) data was analyzed using a normal linear mixed model.|After 4 weeks of treatment in each treatment sequence|Of the 161 randomized subjects, 155 subjects received BIAsp 50 and 158 subjects received BHI 50 (152 subjects received both, 3 subjects only received BIAsp 50 and 6 subjects only received BHI 50). Three (3) subjects in BIAsp 50 group and 9 subjects in BHI 50 group did not contribute to the analysis due to lack of post-randomization measurements.||min*mmol/L||Standard Deviation|Mean
658894|NCT01892020|Secondary|­1-hour PPG Increment Following a Standard Meal Test|The 1-h PPG increment is the difference between the plasma glucose (PG) value at 60 minutes after standard meal test and the fasting PG value.|After 4 weeks of treatment in each treatment sequence|Of the 161 randomized subjects, 155 subjects received BIAsp 50 and 158 subjects received BHI 50 (152 subjects received both, 3 subjects only received BIAsp 50 and 6 subjects only received BHI 50). Three (3) subjects in BIAsp 50 group and 8 subjects in BHI 50 group did not contribute to the analysis due to lack of post-randomization measurements.||mmol/L||Standard Deviation|Mean
658895|NCT01892020|Primary|2-hour PPG (Postprandial Plasma Glucose) Increment Following a Standard Meal Test|The 2-hour PPG increment is the difference between the plasma glucose (PG) value at 120 minutes after standard meal test and the fasting PG value.|After 4 weeks of treatment in each treatment sequence|Of the 161 randomized subjects, 155 subjects received BIAsp 50 and 158 subjects received BHI 50 (152 subjects received both, 3 subjects only received BIAsp 50 and 6 subjects only received BHI 50). Three (3) subjects in BIAsp 50 group and 9 subjects in BHI 50 group did not contribute to the analysis due to lack of post-randomization measurements.||mmol/L||Standard Deviation|Mean
658896|NCT01891890|Other Pre-specified|Pediatric Inventory for Parents|"The Pediatric Inventory for Parents consists of 42 items involving communication, medical care, emotional disturbance, and change in role function. Parents respond to a list of difficult events (such as difficulty sleeping) that are often experienced by parents of children who are seriously ill. Parents indicated how frequently an event occurred by selecting 1=Never, 2=Rarely, 3=Sometimes, 4=Often, or 5=Very often. Raw score values range from 4 to 210 with higher scores indicating increased frequency of difficult events."|Baseline, Month 6|The analysis includes participants who completed the assessment at the specified study visit. Some parents attended a study visit but did not complete the Pediatric Inventory for Parents.||units on a scale||Standard Deviation|Mean
658897|NCT01891890|Other Pre-specified|Parenting Stress Inventory Short Form (PSI-4-SF)|The Parenting Stress Inventory-4-Short Form is a 36 item questionnaire, completed by the parent/guardian, designed to evaluate parenting and family characteristics based upon child characteristics (behavioral and emotional problems), parent characteristics, and situational/demographic life stress. Respondents indicate the degree to which they agree with a variety of statements by selecting 1=strongly agree, 2=agree, 3=not sure, 4=disagree, or 5=strongly disagree. Raw scores range from 36 to 180 and higher scores are associated with higher parental stress.|Baseline, Month 6|The analysis includes participants who completed the assessment at the specified study visit. Some parents attended a study visit but did not complete the PSI-4-SF.||units on a scale||Standard Deviation|Mean
658918|NCT01891669|Secondary|Time to Reach Maximum Observed Serum PF-06263507 Concentration (Tmax)||Baseline,Cycle 1 Day 1 pre-dose,1,4,8,12,24, and 48 hrs post dose,Day 5,Day 8 and Day 15;Day 1 of Cycle 2 and 3,Day 1 of Cycle 4 pre-dose,1,8,12,24 hr post dose, Day 8 and Day 15,every cycle thereafter on day 1 pre-dose, and up to 21 days after last dose.|All enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.||hour||Full Range|Median
658898|NCT01891890|Other Pre-specified|Pediatric Neuro-QOL Score|The Pediatric Neuro-QOL is a Quality of Life instrument developed in conjunction with NIH with a pediatric specific form utilized in this protocol. Pediatric Neuro-QOL assesses the domains of Anger, Anxiety, Cognition, Depression, Fatigue, Pain, Social Relations, and Stigma. Each domain has 8 to 10 items and respondents indicate how often they experienced feelings and circumstances related to each domain on a scale of 1 to 5 (such as 1=never, 2=almost never, 3=sometimes, 4=often, 5=almost always). Higher values indicate increased difficulty for most of the scales but this pattern is reversed for two of the domains. Raw scores are rescaled to standardized scores with a mean of 50 and a standard deviation of 10. Higher values for the standardized scores indicate more problematic characteristics while scores below 50 indicate that the child is experiencing less trouble in the domains measured by the Pediatric Neuro-QOL.|Baseline, Month 6|The analysis includes participants who completed the assessment at the specified study visit. This survey was completed by children aged 10 and older.||t-scores||Standard Deviation|Mean
658899|NCT01891890|Other Pre-specified|Affective Reactivity Scale|"The Affective Reactivity Scale is a 7-item survey completed by the child participants which asks questions concerning their level of agreement with statements about anger and irritability. Respondents select between not true (scored as 0), somewhat true (scored as 1), and certainly true (scored as 2). Total scores range from 0 to 14 with higher values indicating increased feelings of annoyance and anger."|Baseline, Month 3, Month 6|The analysis includes participants who completed the assessment at the specified study visit. Some participants attended a study visit but did not complete the Affective Reactivity Scale.||units on a scale||Standard Deviation|Mean
658900|NCT01891890|Other Pre-specified|Youth Self Report||6 months|As this study was terminated early, the scoring algorithm was not programmed for this outcome measure.|||||
658901|NCT01891890|Other Pre-specified|The Number of Participants With a Positive Response on the Columbia-Suicide Severity Rating Scale (C-SSRS)|"Suicidal behaviors and suicidal ideation were assessed through an interview using the Columbia-Suicide Severity Rating Scale (C-SSRS). The C-SSRS guides interviewers to ask a series of simple questions in order to identify people at risk for suicide, as well as the severity and urgency of suicidal thoughts and behaviors. The Children's Baseline/Screening C-SSRS was used at the initial study visit while the Children's Since Last Visit C-SSRS was used for subsequent study visits. Any responses of yes to the C-SSRS questions are considered a positive response, indicating that the participant is experiencing thoughts of suicide or has exhibited suicidal behaviors."|Baseline, Month 3, Month 6|The analysis includes participants who completed the assessment at the specified study visit. Some participants attended a study visit but did not complete the C-SSRS.||Participants|||Count of Participants
658902|NCT01891890|Other Pre-specified|Grooved Pegboard|The Grooved Pegboard assesses fine motor speed and dexterity. The participant fits keyhole-shaped pegs into similarly shaped holes on a square board. The pegs, which have an edge along one side, must be rotated to match the holes before they can be inserted. The scores represent the number of seconds it took for the participant to correctly insert the pegs into the require number of grooves, using their dominant hand.|Baseline, Month 6|The analysis includes participants who completed the assessment at the specified study visit. Some participants attended a study visit but did not complete the Grooved Pegboard task.||Seconds||Standard Deviation|Mean
658903|NCT01891890|Other Pre-specified|Symbol Digit Modalities Test|Symbol Digit Modalities Test (SDMT) is a test of graphomotor speed using numbers as the response rather than copying symbols, and is timed at 90 seconds. The SDMT is designed for people who are 8 years of age and older and detects brain dysfunction as well as measures function over time. Possible total scores range from 0 to 110; where 110 indicates that all values were entered within the 90 second limit. An increase between initial and retest scores indicates that the respondent is correctly matching numbers to symbols at a faster speed. The SDMT was administered at the Month 3 and Month 6 visits for this study.|Month 3, Month 6|The analysis includes participants who completed the assessment at the specified study visit. Participants who were 8 years old or older were eligible to complete the Symbol Digit Modalities Test.||number of correct responses||Standard Deviation|Mean
658904|NCT01891890|Other Pre-specified|Story Memory|"Story Memory will be measured at baseline with the Children's Memory Scale (CMS) and then with the Wide Range Assessment of Memory and Learning-2 (WRAML-2) at the 6 month follow up visit. Two different tests are used to avoid practice effects in memory assessment associated with repeated assessments using the same stimulus material. The Story Memory sub-test of the CMS and the WRAML-2 Story Memory are measures of prose passage recall. Stories are read to the subject for recall, with different stories presented based upon participant age. Scores are converted to percentile ranks for both measurements of story memory. Possible scores can fall between the 1st and 99th percentile and higher values indicate better performance with story recall. Values between the 9th and 25 percentiles are considered low average, values between the 25th and 75th percentiles are average, while values between the 75th and 91st percentile are high average."|Baseline, Month 6|The analysis includes participants who completed the assessment at the specified study visit. Some participants attended a study visit but did not complete the Story Memory measurement.||percentiles||Standard Deviation|Mean
658905|NCT01891890|Other Pre-specified|Wechsler Intelligence Scale for Children-IV Processing Speed|Coding and Symbol Search subtests from the Wechsler Intelligence Scale for Children (WISC)-IV are measures of processing speed and combine to form the Processing Speed Index. Processing speed refers to how quickly the child understands and responds to information. Coding presents children with a row of boxes containing a numeral in the top line and a symbol in the bottom line with the task of copying the symbol corresponding to each numeral as quickly as possible in 120 seconds. In Symbol Search, children are given rows of symbols and target symbols and are asked to mark whether or not the target symbols appear in each row as quickly as possible during 120 seconds. Composite scores compare the test-taker to peers with a mean score of 100 and a standard deviation of 15. Possible scores range from 40 to 160 with higher scores indicating increased processing speeds. Scores between 85 and 115 are considered average, with 2/3 of test takers falling between these values.|Baseline, Month 3, Month 6|The analysis includes participants who completed the assessment at the specified study visit. Some participants attended a study visit but did not complete the WISC-IV.||units on a scale||Standard Deviation|Mean
658919|NCT01891669|Secondary|Overall Survival|Overall survival was defined as the time from initial dose until death from any cause, and was measured in the intent-to-treat population.|Baseline to death|All enrolled participants||pariticpants|||Number
658906|NCT01891890|Secondary|Child Behavior Checklist|The Child Behavior Checklist is a measure of specific behavioral and emotional problems are rated by the child’s parent or guardian. The Child Behavior Checklist examines three domains (Social Functioning, Mood and Anxiety Symptoms, and Externalizing Symptoms) by assessing 118 problem items that describe specific behavioral and emotional problems. Respondents indicate how accurately the statements describe the child by selecting from options on a 3-point Likert-type scale (0=Not True, 1= Somewhat or Sometimes True, or 2=Very True or Often True). Total raw scores are converted to t-scores with a mean of 50 and standard deviation of 10. A t-score of 67 or greater is considered to be in the clinical range for problematic behavior.|Baseline, Month 6|The analysis includes participants who completed the assessment at the specified study visit. Some participants attended a study visit but did not complete the Child Behavior Checklist.||t-scores||Standard Deviation|Mean
658907|NCT01891890|Primary|Conners' Continuous Performance Test II (CPT-II) Confidence Index|"The Conners’ Continuous Performance Test II (CPT-II) is a measure of sustained attention. Letters are individually presented on a computer screen, and participants are instructed to press the space bar when they are presented with any letter except the letter X. For children younger than 6 years of age at enrollment, the Kiddie CPT will be used in which the child is instructed to press the space bar every time the ball appears on the screen. The outcome measure is a confidence index representing the probability that the respondent has a clinically relevant problem in sustained attention. Possible scores range from 0 to 100. Scores between 40 and 60 are considered inconclusive while scores above 60 indicate that the child exhibits inattentiveness."|Baseline, Month 6|The analysis includes participants who completed the assessment at the specified study visit. Some participants attended a study visit but did not complete the CPT-II.||Confidence Index||Standard Deviation|Mean
658908|NCT01891864|Secondary|Immunogenicity: Measurement of Rate of ADA Formations Against GP2015 Etanercept and Enbrel ® Etanercept|Immunogenicity was analyzed by the percentage of patients with positive anti-drug antibodies (ADA) to either GP2015 Etanercept or Enbrel ® up to Week 52.|Week 52|The analysis was performed on immunogenicity set consisting of patients who provided data for ADA assessment of etanercept at baseline visit.||percentage patients with positive ADA|||Number
658909|NCT01891864|Secondary|Injection Site Reactions|Percentage of patients with injection site reactions up to Week 52|Week52|The analysis was performed on safety set including all patients who took at least 1 dose of study treatment||percentage of patients with ISRs|||Number
658910|NCT01891864|Secondary|PASI 50, 75 and 90 Response Rates|Percentage of patients achieving Psoriasis Area and Severity Index (PASI) 50, PASI 75, and PASI 90 responses at Week 12. PASI 50 response: patients who achieved ≥ 50% improvement (reduction) in PASI score compared to baseline were defined as PASI 50 responders .PASI 90 response: patients who achieved ≥ 90% improvement (reduction) in PASI score compared to baseline were defined as PASI 90 responders .|Week12|The analysis of this secondary outcome measure was based on the per-protocol set (PPS) consisting of patients who completed study until 12 weeks without any major protocol deviation.||percentage of patients|||Number
658911|NCT01891864|Secondary|Percent Change From Baseline in PASI Score up to Week 12|The key secondary efficacy endpoint was the % change from baseline in PASI score up to Week 12. PASI scores can range from 0, corresponding to no signs of psoriasis up to theoretic maximum of 72.0, which means a higher PASI score reflects a higher psoriasis activity. Two approaches (longitudinal approach applying a Mixed Model Repeated Measures and Averaged Treatment Effect approach applying an ANCOVA model) were employed in order to calculate 2-sided 95% confidence intervals (CI) for the difference between the treatment groups.|12 weeks|The analysis was based on the per-protocol set (PPS) consisting of patients who completed study until 12 weeks without any major protocol deviation.||percentage difference||Standard Error|Least Squares Mean
658912|NCT01891864|Primary|PASI 75 Response Rate at Week 12 - GP2015 Etanercept vs. Enbrel ® Etanercept|The 95% CI for the Psoriasis Area and Severity Index (PASI) 75 response rate differences at Week12 between GP2015 Etanercept and Enbrel ® Etanercept. PASI 75 response: patients who achieved ≥ 75% improvement (reduction) in PASI score compared to baseline were defined as PASI 75 responders. PASI scores can range from 0, corresponding to no signs of psoriasis up to theoretic maximum of 72.0, which means a higher PASI score reflects a higher psoriasis activity.|Week 12|The analysis of the primary outcome measure was based on the per-protocol set (PPS) consisting of patients who completed study until 12 weeks without any major protocol deviation.||% of patients achieving PASI75 response|||Number
658913|NCT01891734|Secondary|Client Satisfaction Questionnaire (CSQ-8)|The 8-item Client Satisfaction Questionnaire (CSQ-8) is rated on an 8-32 scale. Higher scores represent greater satisfaction with the intervention.|6 weeks|||units on a scale||Standard Deviation|Mean
658914|NCT01891734|Secondary|Short Form Health Survey-12-Veterans (SF-12 V) Mental Composite Score|The 12-item Short Form Health Survey-12-Veterans (SF-12 V) Mental Composite Score is rated on a 0-100 scale. Higher scores represent better mental health functioning.|6 weeks, 12 weeks|These data include all participants who completed the 6-week follow-up assessment. Two participants from the PST-MF group did not complete the 6-week follow-up.||units on a scale||Standard Deviation|Mean
658915|NCT01891734|Primary|Depression Anxiety and Stress Scale (DASS)|The 7-item depression subscale on the Depression Anxiety and Stress Scale (DASS) is measured on a 0-42 scale. Higher scores represent worse depression symptoms. The 7-item anxiety subscale on the Depression Anxiety and Stress Scale (DASS) is measured on a 0-42 scale. Higher scores represent worse anxiety symptoms. The 7-item stress subscale on the Depression Anxiety and Stress Scale (DASS) is measured on a 0-42 scale. Higher scores represent worse stress symptoms.|6 weeks, 12 weeks|||units on a scale||Standard Deviation|Mean
658916|NCT01891669|Secondary|Time to Reach Maximum Observed Serum PF-06264490 Concentration (Tmax)||Baseline,Cycle 1 Day 1 pre-dose,1,4,8,12,24, and 48 hrs post dose,Day 5,Day 8 and Day 15;Day 1 of Cycle 2 and 3,Day 1 of Cycle 4 pre-dose,1,8,12,24 hr post dose, Day 8 and Day 15,every cycle thereafter on day 1 pre-dose, and up to 21 days after last dose.|All enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.||hour||Full Range|Median
658917|NCT01891669|Secondary|Time to Reach Maximum Observed Serum PF-06281192 Concentration (Tmax)||Baseline,Cycle 1 Day 1 pre-dose,1,4,8,12,24, and 48 hrs post dose,Day 5,Day 8 and Day 15;Day 1 of Cycle 2 and 3,Day 1 of Cycle 4 pre-dose,1,8,12,24 hr post dose, Day 8 and Day 15,every cycle thereafter on day 1 pre-dose, and up to 21 days after last dose.|All enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.||hour||Full Range|Median
658920|NCT01891669|Secondary|Objective Response|Number of particpants with objective response: confirmed CR or confirmed PR according to RECIST. CR was defined as the disappearance of all target lesions. A PR was defined as a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. To be assigned a status of PR or CR, changes in tumor measurements in participants with responding tumors had to have been confirmed by repeat studies that were performed ≥ 4 weeks after the criteria for response were first met.|Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months.|Participants who had received at least one dose of study medication and had a baseline tumor assessment||pariticpants|||Number
658921|NCT01891669|Secondary|Number of Participants With Best Overall Response (BOR)|Number of participants with best overall response. Complete response (CR)=disappearance of all target lesions. Partial Response (PR)>=30% decrease in sum of longest dimensions of lesions taking as reference baseline sum longest dimensions. Progressive disease (PD) >=20% increase in sum of longest dimensions of lesions taking as a reference smallest sum of the longest dimensions since treatment start, or the appearance of >=1 new lesion. Stable disease (SD)=neither shrinkage for PR or increase for PD taking as reference smallest sum of longest dimensions since treatment start.|Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months.|Participants who had received at least one dose of study medication and had a baseline tumor assessment||pariticpants|||Number
658922|NCT01891669|Secondary|Number of Participants With Positive Anti-PF-06263507 Antibody|The number of participants with positive anti-PF-06263507 antibody.|Pre-dose Day 1, Cycle 1 Day 15, Day 1 of every Cycle, up to 21 days after the last dose of study medication|All enrolled participants who received at least one dose of study medication.||Participants|||Number
658923|NCT01891669|Secondary|Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria|Criteria for potentially clinically important (PCI) change in vital signs included: sitting systolic blood pressure (SBP) of <90 millimeters of mercury (mm Hg) or change in sitting SBP of >=30 mm Hg, sitting diastolic blood pressure (DBP) of <50 mm Hg or change in sitting DBP of >=20 mm Hg, sitting pulse rate of <40 or >120 beats per minute (bpm).|Baseline, Days 1, 3, 8 and 15 for Cycle 1, Days 1, 8, 15 for Cycle 2 and subsequent cycles, end of treatment, and follow-up.|All enrolled participants who received at least one dose of study medication.||Participants|||Number
658924|NCT01891669|Secondary|Number of Participants With Abnormalities in Urine Protein in All Cycles.|Number of participants with NCI CTCAE (version 4.0) grade 1 to 4 abnormalities in urine protein.|Baseline, Day 15 for Cycle 1, Day 1 for Cycle 2 and subsequent cycles, and end of treatment|All enrolled participants who received at least one dose of study medication.||Participants|||Number
658925|NCT01891669|Secondary|Number of Participants With Chemistry Test Abnormalities in All Cycles.|Number of participants with NCI CTCAE (version 4.0) grade 1 to 4 chemistry tests abnormalities.|Baseline, Days 1, 3, 8 and 15 for Cycle 1, Days 1, 8, 15 for Cycle 2 and subsequent cycles, and end of treatment|All enrolled participants who received at least one dose of study medication.||Participants|||Number
658926|NCT01891669|Secondary|Number of Participants With Hematological Test Abnormalities in All Cycles.|Number of participants with NCI CTCAE (version 4.0) grade 1 to 4 hematological test abnormalities.|Baseline, Days 1, 3, 8 and 15 for Cycle 1, Days 1, 8, 15 for Cycle 2 and subsequent cycles, and end of treatment|All enrolled participants who received at least one dose of study medication.||Participants|||Number
658927|NCT01891669|Secondary|Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs are events which occurred between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. If the same participant in a given treatment had more than 1 occurrence in the same preferred term event category, only the worst CTCAE grade was reported.|Baseline, Day 1 to 15 for Cycle 1, Day 1 to end of treatment for Cycle 2 and subsequent cycles, and follow-up.|All enrolled participants who received at least one dose of study medication.||participants|||Number
658928|NCT01891669|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs are events which occurred between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. If the same participant in a given treatment had more than 1 occurrence in the same preferred term event category, only the worst CTCAE grade was reported.|Baseline, Day 1 to 15 for Cycle 1, Day 1 to end of treatment for Cycle 2 and subsequent cycles, and follow-up.|All enrolled participants who received at least one dose of study medication.||participants|||Number
658929|NCT01891669|Primary|Number of Participants With Dose-limiting Toxicities (DLT)|DLT was defined as any of the following adverse events (AEs) occurring in the first cycle of treatment (21 days) which were attributable to PF-06263507: 1) Grade 4 neutropenia lasting >7 days, 2) Febrile neutropenia, 3) Grade >=3 neutropenia with infection, 4) Any grade thrombocytopenia associated with clinically significant or life-threatening bleeding, 4) Grade 4 thrombocytopenia, 5) Any grade >=3 non-hematologic toxicities, 6) A positive cardiac troponin I result, 7) Persisting non-hematologic toxicities resulted in more than 2 weeks delay in receiving the next scheduled cycle. Severity of AEs was graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.|Baseline up to Cycle 2 Day 1 (22 days)|All enrolled participants who received at least one dose of study medication.||Participants|||Number
658930|NCT01890967|Secondary|Number of Participants With an Injection Site Reaction||Baseline through Week 24|All randomized participants who received at least one dose of study treatment and had evaluable data.||Participants|||Number
658931|NCT01890967|Secondary|Pharmacokinetics (PK): Area Under the Concentration-Time Curve at Steady-State (AUC,ss) for LY3015014||Week 12-16 (Q4W) - Predose, Week 8-16 (Q8W) - Predose|All randomly assigned participants who received at least one dose of the study medication and had evaluable data.||μg∙hr/mL||Geometric Coefficient of Variation|Geometric Mean
659175|NCT01885871|Primary|Median VAS Improvement Score as Assessed by Blinded Physician Reviewers|Improvement (clearing) in solar lentigines as assessed by blinded physician reviewers using a VAS 4 point scale 0-3 where 0=no change and 3=Very much improved.|12 weeks post- final treatment|Based on blinded photographic assessments of 20 subjects. Scores >/=1 indicate clearing.||units on a scale||95% Confidence Interval|Median
658932|NCT01890967|Secondary|Percentage Change From Baseline in Free Proprotein Convertase Subtilisin/Kexin Type 9 Antibody (PCSK9) Levels|LS Mean was calculated using MMRM analysis with baseline measurement, disease classification, statin dose, treatment, visit, and treatment by visit interaction included in the model. Percent change from baseline response is the dependent variable.|Baseline, Week 16|mITT is defined as all patients in the ITT population who had at least one baseline measurement and one post-randomization measurement of the variable that is analyzed.||Percentage change||Standard Error|Least Squares Mean
658933|NCT01890967|Secondary|Percentage Change From Baseline in Total Proprotein Convertase Subtilisin/Kexin Type 9 Antibody (PCSK9) Levels|LS Mean was calculated using MMRM analysis with baseline measurement, disease classification, statin dose, treatment, visit, and treatment by visit interaction included in the model. Percent change from baseline response is the dependent variable.|Baseline, Week 16|mITT is defined as all patients in the ITT population who had at least one baseline measurement and one post-randomization measurement of the variable that is analyzed.||Percentage change||Standard Error|Least Squares Mean
658934|NCT01890967|Secondary|Number of Participants Who Develop Treatment Emergent Anti-LY3015014 Antibodies||Baseline through Week 24|All randomized participants who received at least one dose of study treatment and had evaluable data.||Participants|||Number
658935|NCT01890967|Secondary|Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP)|LS Mean was calculated using MMRM analysis with baseline measurement, disease classification, statin dose, treatment, visit, and treatment by visit interaction included in the model. Percent change from baseline response is the dependent variable.|Baseline, Week 16|mITT is defined as all patients in the ITT population who had at least one baseline measurement and one post-randomization measurement of the variable that is analyzed.||Percentage change||Standard Error|Least Squares Mean
658936|NCT01890967|Secondary|Percentage Change From Baseline in Lipoprotein(a) [Lp(a)]|Data was log-transformed for MMRM analysis, with change from baseline as the dependent variable, and baseline measurement, disease classification, statin dose, treatment, visit, and treatment by visit interaction included as independent variables. Percentage change from baseline in the original scale was then back-calculated from the log-transformed MMRM analysis.|Baseline, Week 16|mITT is defined as all patients in the ITT population who had at least one baseline measurement and one post-randomization measurement of the variable that is analyzed.||Percentage Change||Standard Error|Least Squares Mean
658937|NCT01890967|Secondary|Percentage Change From Baseline in Apolipoprotein A1 (Apo A1), Apolipoprotein B (Apo B)|LS Mean was calculated using MMRM analysis with baseline measurement, disease classification, statin dose, treatment, visit, and treatment by visit interaction included in the model. Percent change from baseline response is the dependent variable.|Baseline, Week 16|mITT is defined as all patients in the ITT population who had at least one baseline measurement and one post-randomization measurement of the variable that is analyzed.||Percentage change||Standard Error|Least Squares Mean
658938|NCT01890967|Secondary|Percentage Change From Baseline in LDL-C, Total Cholesterol (TC), High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), Non-HDL-C|LS Mean was calculated using mixed model repeated measures (MMRM) analysis with baseline measurement, disease classification, statin dose, treatment, visit, and treatment by visit interaction included in the model. Percent change from baseline response is the dependent variable.|Baseline, Week 16|mITT is defined as all patients in the ITT population who had at least one baseline measurement and one post-randomization measurement of the variable that is analyzed.||Percentage change||Standard Error|Least Squares Mean
658939|NCT01890967|Primary|Percentage Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)|Least square (LS) Means was calculated using analysis of covariance (ANCOVA) adjusted for disease classification, statin dose, baseline LDL-C measurement. Percent change from baseline response is the dependent variable.|Baseline, Week 16|Modified Intent to Treat (mITT) is defined as all patients in the ITT population who had at least one baseline measurement and one post-randomization measurement of the variable that is analyzed.||Percentage change||Standard Error|Least Squares Mean
658940|NCT01890954|Primary|Percent of Time Spent Near Normoglycemia|Percentage of time that blood glucose (BG) values (measured with both finger-stick and CGM) were near normoglycemia (70-180 mg/dL).|8 hours|||percentage time near normoglycemia||Standard Error|Mean
658941|NCT01890915|Other Pre-specified|Sweat Rate|To determine the change in sweat rate using QSweat methodology (WR TestWorks) from 30 minutes at 79 degrees F compared to after up to 2 hours at 95 degrees F. Sweat collection capsules will be placed on the left lateral anterior shoulder, volar aspect of the distal forearm, proximal anterior thigh, and mid-lateral calf (dermatomes C5, T1, L3, L5) for measurement of sweat rate. Hypothesis: Persons with tetraplegia compared with AB will have less of a percent change in average sweat rate after heat exposure.|2 hours|||Percent change||Standard Deviation|Mean
658942|NCT01890915|Secondary|Cognitive Performance - Stroop Interference T-Scores|To determine the change in cognitive performance as measured by the Stroop Color and Word Interference T-Scores, measured after 30 min at 79 degrees F and after up to 2 hours at 95 degrees F. Interference T-Scores are derived from the difference between the raw Color-Word score and the projected Color-Word score (which is, in turn, based on the raw scores obtained in the Word and Color portions of the Test). Lower scores indicate poorer performance, and a positive percent change in T-scores indicates improved performance. Hypothesis: Persons with tetraplegia compared with AB will have a greater change in cognitive performance from baseline (79 degrees) to warm exposure (95 degrees).|2 hours|||Percent change||Standard Deviation|Mean
658943|NCT01890915|Primary|Core Body Temperature|To determine the change in core body temperature in the seated position from 79 degrees F for 30 minutes to 95 degrees F for up to 2 hours. Hypotheses: Persons with tetraplegia will have a greater increase in core body temperature than able-bodied (AB) control subjects. Core body temperature in AB persons will be maintained.|2 hours|||Percent Change||Standard Deviation|Mean
658944|NCT01890785|Primary|Cmax for D-amphetamine|d-Amphetamine is a metabolite of Lisdexamfetamine Dimesylate and is an active form that is responsible for the drug's therapeutic activity.|Up to 96 hours-post-dose|Pharmacokinetic Set consisted of all subjects in the Safety Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||ng/ml||Standard Deviation|Mean
660121|NCT01866293|Primary|Maximally Tolerated Dose|This trial will be a standard 3 by 3 dose escalation design, where three daily dose levels (20mg, 40mg, and 60mg) will be investigated.|1 year|9 participants are evaluable. 2 participants never started treatment.||mg|||Number
658945|NCT01890785|Primary|AUC for D-amphetamine|d-Amphetamine is a metabolite of Lisdexamfetamine Dimesylate and is an active form that is responsible for the drug's therapeutic activity.|Up to 96 hours post-dose|Pharmacokinetic Set consisted of all subjects in the Safety Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||ng*h/ml||Standard Deviation|Mean
658946|NCT01890785|Primary|Maximum Plasma Concentration (Cmax) for Lisdexamfetamine Dimesylate|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Up to 96 hours post-dose|Pharmacokinetic Set consisted of all subjects in the Safety Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||ng/ml||Standard Deviation|Mean
658947|NCT01890785|Primary|Area Under the Plasma Concentration-time Curve (AUC) for Lisdexamfetamine Dimesylate|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Up to 96 hours post-dose|Pharmacokinetic Set consisted of all subjects in the Safety Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||ng*hr/ml||Standard Deviation|Mean
658948|NCT01890759|Secondary|Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra®|Injection site: Tenderness, Erythema, and Swelling. Systemic: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, Irritability. Grade 3 Injection site: Tenderness, Cries when injected limb is moved or the movement of the injected limb is reduced. Erythema and Swelling, ≥50 mm. Grade 3 Systemic: Fever, >39.5C; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, >3 hours; Drowsiness, Sleeping most of the time or difficult to wake; Appetite lost, Refuses ≥3 feeds/meals or refuses most feeds/meals; Irritability, Inconsolable.|Day 0 up to Day 7 post-each vaccination|Solicited injection site and systemic reactions were assessed in the Safety Analysis Set.||Percentage of participants|||Number
658949|NCT01890759|Secondary|Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titer Ratios of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®|Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-BR assay.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Geometric mean titer ratios were assessed in the Per Protocol Analysis Set.||Titer ratios||95% Confidence Interval|Geometric Mean
658950|NCT01890759|Secondary|Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titer Ratios of Meningococcal Serogroups A, C, Y, and W-135 Following Vaccination With Menactra®|Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Geometric mean titer ratios were assessed in the Per Protocol Analysis Set.||Titer ratios||95% Confidence Interval|Geometric Mean
658951|NCT01890759|Secondary|Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®|Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-BR.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Geometric mean titers were assessed in the Per Protocol Analysis Set.||Titers (1/dil)||95% Confidence Interval|Geometric Mean
658952|NCT01890759|Secondary|Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®|Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Geometric mean titers were assessed in the Per Protocol Analysis Set.||Titers (1/dil)||95% Confidence Interval|Geometric Mean
658953|NCT01890759|Secondary|Percentage of Participants With At Least Four-Fold Rise in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Baby Rabbit Complement Following Vaccination With Menactra®|Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-BR assay.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Seroprotection was assessed in the Per Protocol Analysis Set.||Percentage of participants|||Number
658954|NCT01890759|Secondary|Percentage of Participants With At Least Four-Fold Rise in Threshold Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra®|Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay.|Day 0 (pre-vaccination) and Day 28 post-vaccination|The threshold was assessed in the Per Protocol Analysis Set.||Percentage of participants|||Number
658955|NCT01890759|Secondary|Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:4 by Serum Bactericidal Assay Using Baby Rabbit Complement Before and Following Vaccination With Menactra®|Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-BR assay. The threshold was defined as antibody titers ≥ 1:4.|Day 0 (pre-vaccination) and Day 28 post-vaccination|The threshold was assessed in the Per Protocol Analysis Set.||Percentage of participants|||Number
658956|NCT01890759|Secondary|Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:4 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®|Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay. The threshold was defined as antibody titers ≥ 1:4.|Day 0 (pre-vaccination) and Day 28 post-vaccination|The threshold was assessed in the Per Protocol Analysis Set.||Percentage of participants|||Number
658996|NCT01890577|Secondary|ESA/Aranesp Dose Ratio|"Ratio of the calculated mean weekly dose equivalent of an ESA administered immediately prior to conversion to treatment with Aranesp, to the calculated mean weekly dose equivalent of the first dose of Aranesp administered at commencement. Not applicable to participants who were ESA-naive at time of Aranesp commencement.
Due to the premature termination of the study no outcome measure data were analyzed."|Day of commencement of Aranesp||||||
658957|NCT01890759|Secondary|Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:8 by Serum Bactericidal Assay Using Baby Rabbit Complement Before and Following Vaccination With Menactra®|Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-BR assay. The threshold was defined as antibody titers ≥ 1:8.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Threshold was assessed in the Per Protocol Analysis Set.||Percentage of participants|||Number
658958|NCT01890759|Secondary|Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:8 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®|Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay. The threshold was defined as antibody titers ≥ 1:8.|Day 0 (pre-vaccination) and Day 28 post-vaccination|The threshold was assessed in the Per Protocol Analysis Set.||Percentage of participants|||Number
658959|NCT01890759|Secondary|Percentage of Participants With At Least Four-Fold Rise in Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra®|Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay.|Day 0 (pre-vaccination) and Day 28 post-vaccination|The threshold was assessed in the Per Protocol Analysis Set.||Percentage of participants|||Number
658960|NCT01890759|Secondary|Percentage of Participants Achieving the Threshold Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:4 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®|Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay. The threshold was defined as antibody titers ≥ 1:4.|Day 0 (pre-vaccination) and Day 28 post-vaccination|The threshold was assessed in the Per Protocol Analysis Set.||Percentage of participants|||Number
658961|NCT01890759|Primary|Percentage of Participants Achieving Seroprotection Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:8 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®|Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay. Seroprotection was defined as antibody titers ≥ 1:8.|Day 0 (pre-vaccination) and Day 28 post-second vaccination|Seroprotection was assessed in the Per Protocol Analysis Set.||Percentage of participants|||Number
658962|NCT01890746|Primary|Worst-case Post Baseline Change in Temperature Values From Baseline|The worst-case post Baseline high and low changes in temperature values from Baseline are presented. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Post Baseline was defined as the highest and lowest non-missing post Baseline value respectively. Change from Baseline was calculated as the post Baseline value minus the Baseline value.|Baseline and up to Day 42 of the latest chemotherapy cycle (Up to 8 weeks)|Safety population. Only those participants available at the indicated time points were analyzed (represented by n=X, X in the category titles).||Degrees Celsius||Standard Deviation|Mean
658963|NCT01890746|Primary|Worst-case Post Baseline Change in Blood Pressure Values From Baseline|The worst-case post Baseline high changes in systolic blood pressure (SBP) and diastolic blood pressure (DBP) values from Baseline are presented. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Change from Baseline was calculated as the visit value minus the Baseline value.|Baseline and up to Day 42 of the latest chemotherapy cycle (Up to 8 weeks)|Safety population||millimeter of mercury (mmHg)||Standard Deviation|Mean
658964|NCT01890746|Primary|Worst-case Change From Baseline in Pulse Rate Values|The worst-case post Baseline high and low changes in pulse rate values from Baseline are presented. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Post Baseline is defined as the highest and lowest non-missing post Baseline value respectively. Change from Baseline was calculated as the post Baseline value minus the Baseline value.|Baseline and up to Day 42 of the latest chemotherapy cycle (Up to 8 weeks)|Safety population. Only those participants available at the indicated time points were analyzed (represented by n=X, X in the category titles)||Beats/minute||Standard Deviation|Mean
658965|NCT01890746|Primary|Number of Participants With Worst-case Changes From Baseline in the Eastern Cooperative Oncology Group (ECOG) Performance Status|The number of participants with worst case post-baseline changes (improved, no change, deteriorated) are presented.|Baseline and Day 42 of the latest chemotherapy cycle (Up to 8 weeks)|Participants in the Safety Population who provided Baseline and post-Baseline assessments.||Participants|||Number
658966|NCT01890746|Primary|Number of Participants With Worst-case Changes From Baseline in Electrocardiogram (ECG) Values|The number of participants with worst case post-baseline changes (normal, abnormal - not clinically significant [NCS], abnormal - clinically significant [NS]) in ECG QT prolonged values are presented. The protocol does not define the criteria for normal, abnormal-NCS and abnormal CS ECG. The outcome was based solely on the investigator interpretation of ECG tracings.|Baseline and Day 42 of the latest chemotherapy cycle (Up to 8 weeks)|Safety population||Participants|||Number
658967|NCT01890746|Primary|Number of Participants With Liver Events.|The number of participants with liver enzyme (ALT, AST, ALP, Total bilirubin) abnormalities while receiving study treatment in each arm are presented.|8 weeks|Safety population||Participants|||Number
658968|NCT01890746|Primary|Number of Participants With Worst-case Grade Changes From Baseline in the Clinical Chemistry Parameters|The number of participants with a maximum post-baseline grade increase of Grade 3 or Grade 4 from their baseline grade are presented. Clinical Clinical Chemistry parameters included only lab tests that are gradable by CTCAE v4.0.|Baseline and up to Day 42 of the latest chemotherapy cycle (Up to 8 weeks)|Safety population||Participants|||Number
658969|NCT01890746|Primary|Number of Participants With Worst-case Grade Changes From Baseline in the Hematology Parameters|The number of participants with a maximum post-baseline grade increase of Grade 3 (G3) or Grade 4 (G4) from their baseline grade are presented. Hematology parameters included only lab tests that are gradable by Common Terminology Criteria for Adverse Events (CTCAE) v4.0.|Baseline and up to Day 42 of the latest chemotherapy cycle (Up to 8 weeks)|Safety population||Participants|||Number
658997|NCT01890577|Secondary|Erythropoiesis Stimulating Agent (ESA) Usage|Due to the premature termination of the study no outcome measure data were analyzed.|Over the 15-month observation period||||||
658970|NCT01890746|Primary|Change From Baseline in the Left Ventricular Ejection Fraction (LVEF).|LVEF is a measurement of the percentage of blood leaving heart each time it contracts. LVEF was assessed by an echocardiogram (ECHO) or Multiple Gated Acquisition scan (MUGA). Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Change from Baseline was calculated as the Day 42 value minus the Baseline value.|Baseline and Day 42 of the latest chemotherapy cycle (Up to 8 weeks)|Participants in the Safety Population who provided Baseline and Day 42 LVEF measurements.||LVEF percent||Standard Deviation|Mean
658971|NCT01890746|Primary|Number of Participants With Any Adverse Events (AE) and Any Serious Adverse Events (SAE) as a Measure of Safety and Tolerability.|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or is associated with liver injury and impaired liver function.|From the time the first dose of study treatment was administered until 30 days following discontinuation of investigational product regardless of initiation of a new cancer therapy or transfer to hospice|Safety population: all subjects who received at least one dose of investigational product.||Participants|||Number
658972|NCT01890694|Secondary|Tolerability of Diuretic Therapy|Improved ability to tolerate diuretic therapy, as evidenced by reduced adverse events to diuretic therapy and reduced risk of re-hospitalization.|Day 1 until Discharge (participants will be followed for the duration of hospital stay, an expected average of 2 weeks)||||||
658973|NCT01890694|Secondary|Neutrophil Function [Results From the Assay of Neutrophils]|Improved neutrophil function from baseline|Day 1 to Post-discharge (6 months)||||||
658974|NCT01890694|Secondary|Survival|Improved chances of survival when receiving Tolvaptan vs. standard of care|Post-discharge (6 months)||||||
658975|NCT01890694|Secondary|Hospital Readmission Rate|Lower readmission rate|Post-Discharge (6 months)||||||
658976|NCT01890694|Secondary|Renal Function [BUN and Creatinine Laboratory Results]|Improved renal function from baseline|Day 1 to Post-discharge (6 months)||||||
658977|NCT01890694|Secondary|Ascites|Improved control of ascites|Day 1 to Post-discharge (6 months)||||||
658978|NCT01890694|Secondary|Severity of Hepatic Encephalopathy|Change from baseline of Hepatic Encephalopathy|Months 2-6 post-discharge||||||
658979|NCT01890694|Secondary|Severity of Hepatic Encephalopathy|Change from baseline of Hepatic Encephalopathy|Week 1-4 Post-discharge||||||
658980|NCT01890694|Secondary|Severity of Hepatic Encephalopathy|Change from baseline of Hepatic Encephalopathy|participants will be followed for the duration of hospital stay, an expected average of 2 weeks||||||
658981|NCT01890694|Secondary|Severity of Hepatic Encephalopathy|Change from baseline of Hepatic Encephalopathy|Day 8||||||
658982|NCT01890694|Secondary|Severity of Hepatic Encephalopathy|Change from baseline of Hepatic Encephalopathy|Day 6||||||
658983|NCT01890694|Secondary|Severity of Hepatic Encephalopathy|Change from baseline of Hepatic Encephalopathy|Day 4||||||
658984|NCT01890694|Secondary|Severity of Hepatic Encephalopathy|Change from baseline of Hepatic Encephalopathy|Day 2|Data not analyzed. Study terminated|||||
658985|NCT01890694|Primary|Length of Hospital Stay||participants will be followed for the duration of hospital stay, an expected average of 2 weeks|Data were not collected due to premature termination of the trial|||||
658986|NCT01890642|Secondary|Pain at J-tip Deployment|Pain when J-tip deployed assessed by video reviewers using pain scale. The FLACC (Face, legs, activity, cry and consolability) Scale, ranging from 0 (no pain) to 10 (worst pain), was used to assess pain.|1 minute|||units on a scale||Inter-Quartile Range|Median
658987|NCT01890642|Primary|Change in Pain Score on FLACC Scale From Device Deployment to Venipuncture|"Pain score assessed by video reviewer at J-tip, J-tip noise or researcher approach (1 minute) and at venipuncture (3 minutes). The score at J-tip noise/researcher approach was subtracted from the score at venipuncture to give a number indicating the change in pain scores.
The FLACC (Face, legs, activity, cry and consolability) Scale, ranging from 0 (no pain) to 10 (worst pain), was used to assess pain."|3 min|||units on a scale||Standard Error|Mean
658988|NCT01890642|Secondary|Change in Pain Score From Baseline|"Pain score assessed by video reviewer before intervention (0 minute) and at venipuncture (3 minutes). The score at baseline was subtracted from the score at venipuncture to give a number indicating the change in pain scores.
The FLACC (Face, legs, activity, cry and consolability) Scale, ranging from 0 (no pain) to 10 (worst pain), was used to assess pain."|3 min|||units on a scale||Standard Error|Mean
658989|NCT01890642|Secondary|Fist Attempt Success|Proportion of patients where blood draw was successful on first attempt|up to 3 minutes|||participants|||Number
658990|NCT01890642|Secondary|Pain Score|Pain score as assessed by video reviewers. The FLACC (Face, legs, activity, cry and consolability) Scale, ranging from 0 (no pain) to 10 (worst pain), was used to assess pain.|At venipuncture (3 minutes)|||units on a scale||Inter-Quartile Range|Median
658991|NCT01890577|Secondary|Number of Hospitalisations|Due to the premature termination of the study no outcome measure data were analyzed.|Over the 15-month observation period||||||
658992|NCT01890577|Secondary|Number of Red Blood Cell Transfusions|Due to the premature termination of the study no outcome measure data were analyzed.|Over the 15-month observation period||||||
658993|NCT01890577|Secondary|C-Reactive Protein, Albumin, Transferrin Saturation and Serum Ferritin Concentration|Due to the premature termination of the study no outcome measure data were analyzed.|Over the 15-month observation period||||||
658994|NCT01890577|Secondary|Use of Concomitant Therapies: Immunosuppressants, Cardiovascular Medications, Secondary Hypoparathyroidism Medications, Anti-retroviral Therapy|Due to the premature termination of the study no outcome measure data were analyzed.|At each 12-week interval over the observation period||||||
658995|NCT01890577|Secondary|Iron Therapy Use|Due to the premature termination of the study no outcome measure data were analyzed.|Over the 15-month observation period||||||
659001|NCT01890512|Primary|Number of MRI Related Patient Adverse Events and/or Adverse Device Effects During MRI Visit|"The study is aimed at providing confirmatory data of no impact of MRI on device function and patient conditions.
Confirmation of no MRI related patient adverse events and/or adverse device effects during MRI visit are assessed as follows:
no episodes of asystole,
no occurrence of sustained ventricular arrhythmias in the bore,
no loss of capture due to rise in pacing threshold."|one month|||number of MRI related patient adverse ev|||Number
659002|NCT01890473|Secondary|Number of Participants With Blood Hematology, Chemistry Laboratory Values and Urinalysis Laboratory Values Meeting the Marked Abnormality Criteria|Marked abnormality criteria: lower limit of normal (LLN); upper limit of normal (ULN); pretreatment (preRX); cells per microliter (cµ/L); milligram per deciliter (mg/dL); milliequivalent (mEq): Hematology: leukocytes (*10^3 c/µL): <0.75*LLN or >1.25*ULN, or if preRX <LLN, use <0.8*preRX or >ULN, or if preRX>ULN, use >1.2*preRX or <LLN; eosinophils (*10^3 cµ/L): if value >0.750*10^3 c/µL; lymphocytes (*10^3 cµ/L): if value <0.750*10^3 c/µL or if value >7.50*10^3 c/µL. Chemistry: blood urea nitrogen (mg/dL): >2*preRX; creatinine (mg/dL): >1.5*preRX; potassium (mEq/L): <0.9*LLN or >1.1*ULN, or if preRX<LLN, use <0.9*preRX or >ULN, or if preRX>ULN, use 1.1*preRX or <LLN; glucose (mg/dL): <65 mg/dL (low) or >220 mg/dL (high). Urine Blood, urine red blood cell (RBC), urine white blood cell (WBC): if missing PreRX use >= 2, or if Value >= 4, or if preRX = 0 or 0.5 then use >= 2, or if preRX = 1 then use >= 3, or if preRX = 2 or 3 then use >= 4.|Day 1 to 76 days post last dose|All treated participants with laboratory values were included in the safety analysis. n=number of participants evaluated.||participants|||Number
659003|NCT01890473|Secondary|Number of Participants With a Positive Immunogenicity Response Relative to Baseline|Blood samples were screened at baseline, Day 57 and Day 71 for the presence of drug-specific antibodies using Electrochemiluminescence (ECL). A positive immunogenicity response relative to baseline for Anti-Cytotoxic T Lymphocyte Antigen 4-T Cell (CTLA4) and 'possibly immunoglobulin (Ig)’, and ‘Ig and/or Junction Region’, respectively, was defined as: A missing baseline immunogenicity measurement and a positive analytical laboratory reported immunogenicity response post-baseline; A negative baseline immunogenicity response and a positive analytical laboratory reported immunogenicity response post-baseline; A positive baseline immunogenicity response and a positive analytical laboratory reported immunogenicity response post-baseline that has a titer value strictly greater than the baseline titer value. Baseline=Pre-dose value.|Day 57, Day 71|All treated participants with at least one post baseline immunogenicity result reported were included in the immunogenicity analysis. n=number of participants evaluated at the specific time point.||participants|||Number
659004|NCT01890473|Secondary|Number of Participants With Adverse Events of Special Interest|Prospectively identified events of special interest which were a subset of all AEs, and were either SAEs or non-serious AEs, included the following categories: Infections, Autoimmune Disorders, Malignancy, local site reactions, any AE occurring within 24 hours of SC injection. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|Day 1 to 76 days post single dose|All treated participants were included in safety analysis.||participants|||Number
659005|NCT01890473|Secondary|Number of Participants Who Had Serious Adverse Events (SAEs), Adverse Events (AEs) That Led to Discontinuation, or Who Died|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Includes data Day 1 up to 76 days (71 days + 5 day window) post the single dose of study drug.|Day 1 to 76 days post single dose|All treated participants were included in safety analysis.||participants|||Number
659006|NCT01890473|Secondary|Geometric Mean of Volume of Distribution (V/F) of a Single Dose of Subcutaneous (SC) Abatacept - PK-Evaluable Analysis Population|Serum concentrations of abatacept were analyzed using ELISA. Blood samples were collected at Day 1 pre-dose at 0 h, 1, 2, and 8 h post dose, and on subsequent Days, 2 (24 h post dose), 3 (48 h), 5 (96 h), 8 (168 h), 15 (336 h), 29 (672 h) , 43 (1008 h), 57 (1344 h) and 71 (1680 h) following the single administration of abatacept SC. V/F was measured in liters per kilogram body weight (L/kg)|Day 1 to Day 71|PK-evaluable analysis population: All randomized and treated participants with adequately evaluable PK parameters were summarized.||L/kg||Geometric Coefficient of Variation|Geometric Mean
659007|NCT01890473|Secondary|Geometric Mean of Total Body Clearance (CL/F) of a Single Dose of SC Abatacept - PK-Evaluable Analysis Population|Serum concentrations of abatacept were analyzed using ELISA. Blood samples were collected at Day 1 pre-dose at 0 h, 1, 2, and 8 h post dose, and on subsequent Days, 2 (24 h post dose), 3 (48 h), 5 (96 h), 8 (168 h), 15 (336 h), 29 (672 h) , 43 (1008 h), 57 (1344 h) and 71 (1680 h) following the single administration of abatacept SC. CL/F was measured in milliliters per hour per kilogram body weight (mL/h/kg).|Day 1 to Day 71|PK-evaluable analysis population: All randomized and treated participants with adequately evaluable PK parameters were summarized.||mL/h/kg||Geometric Coefficient of Variation|Geometric Mean
659008|NCT01890473|Secondary|Mean of Terminal Phase Elimination Half-life in Serum (T-HALF) of a Single Dose of SC Abatacept - PK-Evaluable Analysis Population|Serum concentrations of abatacept were analyzed using ELISA. Blood samples were collected at Day 1 pre-dose at 0 h, 1, 2, and 8 h post dose, and on subsequent Days, 2 (24 h post dose), 3 (48 h), 5 (96 h), 8 (168 h), 15 (336 h), 29 (672 h) , 43 (1008 h), 57 (1344 h) and 71 (1680 h) following the single administration of abatacept SC. T-HALF was measured in hours (h).|Day 1 to Day 71|PK-evaluable analysis population: All randomized and treated participants with adequately evaluable PK parameters were summarized.||h||Standard Deviation|Mean
659009|NCT01890473|Secondary|Median of Time to Reach Cmax in Serum (Tmax) of a Single Dose of SC Abatacept - PK-Evaluable Analysis Population|Serum concentrations of abatacept were analyzed using ELISA. Blood samples were collected at Day 1 pre-dose at 0 h, 1, 2, and 8 h post dose, and on subsequent Days, 2 (24 h post dose), 3 (48 h), 5 (96 h), 8 (168 h), 15 (336 h), 29 (672 h) , 43 (1008 h), 57 (1344 h) and 71 (1680 h) following the single administration of abatacept SC. Tmax was measured in hours (h).|Day 1 to Day 71|PK-evaluable analysis population: All randomized and treated participants with adequately evaluable PK parameters were summarized.||h||Full Range|Median
659010|NCT01890473|Primary|Adjusted Geometric Mean of Area Under the Serum Concentration-time Curve From Time Zero to Extrapolated to Infinity, AUC (INF), of a Single Dose of SC Abatacept - PK-Evaluable Analysis Population|Serum concentrations of abatacept were analyzed using ELISA. Blood samples were collected at Day 1 pre-dose at 0 hour (h), 1, 2, and 8 h post dose, and on subsequent Days, 2 (24 h post dose), 3 (48 h), 5 (96 h), 8 (168 h), 15 (336 h), 29 (672 h) , 43 (1008 h), 57 (1344 h) and 71 (1680 h) following the single administration of abatacept SC. AUC (INF) was measured in μg*h/mL|Day 1 to Day 71|PK-evaluable analysis population: All randomized and treated participants with adequately evaluable PK parameters were summarized.||μg*h/mL||90% Confidence Interval|Geometric Mean
659011|NCT01890473|Primary|Adjusted Geometric Mean of Area Under the Serum Concentration-time Curve (AUC) From Zero to the Last Time of the Last Quantifiable Concentration (0-T) of a Single Dose of SC Abatacept - PK-Evaluable Analysis Population|Serum concentrations of abatacept were analyzed using ELISA. AUC (0-T) was measured in μg*h/mL. Blood samples were collected at Day 1 pre-dose at 0 h, 1, 2, and 8 h post dose, and on subsequent Days, 2 (24 h post dose), 3 (48 h), 5 (96 h), 8 (168 h), 15 (336 h), 29 (672 h) , 43 (1008 h), 57 (1344 h) and 71 (1680 h) following the single administration of abatacept SC.|Day 1 to Day 71|PK-evaluable analysis population: All randomized and treated participants with adequately evaluable PK parameters were summarized.||μg*h/mL||90% Confidence Interval|Geometric Mean
659012|NCT01890473|Primary|Adjusted Geometric Mean of Maximum Observed Serum Concentration (Cmax) of a Single Dose of Subcutaneous (SC) Abatacept - PK-Evaluable Analysis Population|Serum concentrations of abatacept were analyzed using a validated enzyme-linked immunosorbent assay (ELISA). Cmax was measured in micrograms per milliliter (μg/mL). Blood samples for pharmacokinetic (PK) parameters were collected at Day 1 pre-dose at 0 hour (h), 1, 2, and 8 h post dose, and on subsequent Days, 2 (24 h post dose), 3 (48 h), 5 (96 h), 8 (168 h), 15 (336 h), 29 (672 h) , 43 (1008 h), 57 (1344 h) and 71 (1680 h) following the single administration of abatacept SC.|Day 1 to Day 71|PK-evaluable analysis population: All randomized and treated participants with adequately evaluable PK parameters were summarized.||μg/mL||90% Confidence Interval|Geometric Mean
659013|NCT01890343|Primary|Quantitative Amyloid Image Assessment|The effect of diagnostic group on mean total cortical grey matter florbetapir binding relative to cerebellar cortex is presented as standard uptake value ratios (SUVr).|50-60 minutes after injection|||SUVr||Standard Deviation|Mean
659014|NCT01890343|Primary|Qualitative Amyloid Image Assessment|Four readers blinded to all clinical information classified florbetapir Positron Emission Tomography (PET) images as either positive for amyloid or negative for amyloid. The majority read classification is presented as either positive, negative or tied.|50-60 min after injection|||participants|||Number
659015|NCT01890148|Secondary|Summary Statistics for Patient Diary Variables (Night Time)|"Summary statistics for patient diary variable, observations with no asthma symptoms (night time), by period (safety set).
The screening period was Day -14 to -1. Period 1 was the first half of treatment period, Day 1 to daytime record Day 15. Period 2 was the second half of treatment period, night-time record Day 15 to night-time record Day 29+1.
One participant left the study on day 2, due to adverse event."|Up to 44 days|||Observations|Participants||Number
659016|NCT01890148|Secondary|Summary Statistics for Patient Diary Variables (Day Time)|"Summary statistics for patient diary variable, observations with no asthma symptoms (day time), by period (safety set).
The screening period was Day -14 to -1. Period 1 was the first half of treatment period, Day 1 to daytime record Day 15. Period 2 was the second half of treatment period, night-time record Day 15 to night-time record Day 29+1.
One participant left the study on day 2, due to adverse event."|Up to 44 days|||Observations|Participants||Number
659017|NCT01890148|Secondary|Number of Participants With Adverse Events|Summary of number of participants with adverse events (safety set)|Up to 40 days|||Participants|||Number
659018|NCT01890148|Secondary|Number of Adverse Events|Summary of number of adverse events (safety set)|Up to 40 days|||adverse events|||Number
659019|NCT01890148|Secondary|Summary Statistics for Cmax on Day 29/ Visit T7 (PK Analysis Set)|"Summary statistics including geometric mean and standard error for Cmax on Day 29/ Visit T7 (PK analysis set).
Plasma concentration data beyond 0.5 hrs post dose at Day 29 were missing for one patient. For this patient only Cmin value was reported and the AUC0-4hrs and Cmax values were not reported."|At 0, 0.5, 1, 1.5, 2, 2.5, 3, 4 hours post dose on Day 29 (Visit T7)|||nmol/L||Standard Error|Geometric Mean
659020|NCT01890148|Secondary|Summary Statistics for Cmin on Day 29/ Visit T7 (PK Analysis Set)|"Summary statistics including geometric mean and standard error for Cmin on Day 29/ Visit T7 (PK analysis set).
Plasma concentration data beyond 0.5 hrs post dose at Day 29 were missing for one patient. For this patient only Cmin value was reported and the AUC0-4hrs and Cmax values were not reported."|At 0, 0.5, 1, 1.5, 2, 2.5, 3, 4 hours post dose on Day 29 (Visit T7)|||nmol/L||Standard Error|Geometric Mean
659021|NCT01890148|Secondary|Summary Statistics for AUC0-4hrs on Day 29/ Visit T7 (PK Analysis Set)|"Summary statistics including geometric mean and standard error for AUC0-4hrs on Day 29/ Visit T7 (PK analysis set).
Plasma concentration data beyond 0.5 hrs post dose at Day 29 were missing for one patient. For this patient only Cmin value was reported and the AUC0-4hrs and Cmax values were not reported."|At 0, 0.5, 1, 1.5, 2, 2.5, 3, 4 hours post dose on Day 29 (Visit T7)|||h*nmol/L||Standard Error|Geometric Mean
659022|NCT01890148|Secondary|Summary for Change From Baseline for MMP-9 by Type of Sample|Change from baseline reflects the Day 29 value minus the baseline value.|Baseline and Day 29|PD analysis||ng/ml||Standard Deviation|Mean
659023|NCT01890148|Secondary|Summary for Change From Baseline for GRO-alpha by Type of Sample|Change from baseline reflects the Day 29 value minus the baseline value.|Baseline and Day 29|PD analysis set||pg/ml||Standard Deviation|Mean
659024|NCT01890148|Secondary|Summary for Change From Baseline for IL-8 by Type of Sample|Change from baseline reflects the Day 29 value minus the baseline value.|Baseline and Day 29|PD analysis set||pg/ml||Standard Deviation|Mean
659025|NCT01890148|Primary|Summary for Change From Baseline Neutrophil Cell Counts in Blood|Change from Baseline reflects the Day 2, Day 8, Day 15, Day 22, Day29 and Day 34 minus the baseline value|Baseline, Day 2, Day 8, Day 15, Day 22, Day29 and Day 34|PD Analysis||10^9 cells/L||Standard Deviation|Mean
659026|NCT01890148|Primary|Summary for Change From Baseline Neutrophils in Sputum|Change from Baseline reflects the Day 8, Day22 and Day29 minus the baseline value.|Baseline, Day 8, Day 22 and Day29|PD analysis set||10^9 cells/L||Standard Deviation|Mean
662160|NCT01828099|Secondary|Disease Control Rate (DCR)|DCR defined as the proportion of patients with best overall response of CR, PR, or Stable Disease (SD)|From randomization until death (up to approximately 34 months)||06/2018||||
659027|NCT01890148|Primary|Summary for Change From Baseline of Mean Global Semi-quantitative Score Values for Neutrophils in Bronchial Biopsies|"Change from baseline reflects the Week 4 value minus the baseline value. Baseline value is Day-14 measurement.
For semi-quantitative scores, 1= few number of Neutrophils, 2= moderate number of Neutrophils, 3= abundant of Neutrophils. For this end point the reduction in mean of semi-quantitative (arbitrary) scores indicates better result, i.e. lower numbers of Neutrophils.
The scores given for the biopsies taken at screening and end of treatment is the mean global semi-quantitative scores for the three compartments intraepithelial, subepithelial and submucosal."|Baseline and Week 4|PD analysis set||Units on a scale||Standard Deviation|Mean
659028|NCT01890122|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥2.0%|Clinical response at Week 26 will be assessed by the percentage of participants with a decrease from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) of ≥2.0%.|Baseline and Week 26|Full analysis set consisted of all randomized participants in the safety set (participants who received at least 1 dose of study drug) who had baseline and at least 1 post baseline assessment. LOCF imputation was utilized.||percentage of participants|||Number
659029|NCT01890122|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥1.5%|Clinical response at Week 26 will be assessed by the percentage of participants with a decrease from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) of ≥1.5%.|Baseline and Week 26|Full analysis set consisted of all randomized participants in the safety set (participants who received at least 1 dose of study drug) who had baseline and at least 1 post baseline assessment. LOCF imputation was utilized.||percentage of participants|||Number
659030|NCT01890122|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥1.0%|Clinical response at Week 26 will be assessed by the percentage of participants with a decrease from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) of ≥1.0%.|Baseline and Week 26|Full analysis set consisted of all randomized participants in the safety set (participants who received at least 1 dose of study drug) who had baseline and at least 1 post baseline assessment. LOCF imputation was utilized.||percentage of participants|||Number
659031|NCT01890122|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥0.5%|Clinical response at Week 26 will be assessed by the percentage of participants with a decrease from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) of ≥0.5%.|Baseline and Week 26|Full analysis set consisted of all randomized participants in the safety set (participants who received at least 1 dose of study drug) who had baseline and at least 1 post baseline assessment. LOCF imputation was utilized.||percentage of participants|||Number
659032|NCT01890122|Secondary|Percentage of Participants With Glycosylated Hemoglobin ≤7.5%|Clinical response at Week 26 will be assessed by the percentage of participants with HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) ≤7.5%.|Week 26|Full analysis set consisted of all randomized participants in the safety set (participants who received at least 1 dose of study drug) who had baseline and at least 1 post baseline assessment. LOCF imputation was utilized.||percentage of participants|||Number
659033|NCT01890122|Secondary|Percentage of Participants With Glycosylated Hemoglobin ≤7.0%|Clinical response at Week 26 will be assessed by the percentage of participants with HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) ≤7%.|Week 26|Full analysis set consisted of all randomized participants in the safety set (participants who received at least 1 dose of study drug) who had baseline and at least 1 post baseline assessment. LOCF imputation was utilized.||percentage of participants|||Number
659034|NCT01890122|Secondary|Percentage of Participants With Glycosylated Hemoglobin ≤6.5%|Clinical response at Week 26 will be assessed by the percentage of participants with HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) ≤6.5%.|Week 26|Full analysis set consisted of all randomized participants in the safety set (participants who received at least 1 dose of study drug) who had baseline and at least 1 post baseline assessment. LOCF imputation was utilized.||percentage of participants|||Number
659035|NCT01890122|Secondary|Change From Baseline in Body Weight at Weeks 12 and 26|Change in participant's body weight at Weeks 12 and 26 relative to baseline.|Baseline and Weeks 12 and 26|"Full analysis set consisted of all randomized participants in the safety set (participants who received at least 1 dose of study drug) who had baseline and at least 1 post baseline assessment. LOCF imputation was utilized. n in the category is the number of participants with data available at the given time-point."||kg||Standard Deviation|Median
659036|NCT01890122|Secondary|Percentage of Participants With Marked Hyperglycemia|Marked hyperglycemia is defined as FPG level ≥200 mg/dL (11.1 mmol/L).|Baseline up to Week 26|Full analysis set consisted of all randomized participants in the safety set (participants who received at least 1 dose of study drug) who had baseline and at least 1 post baseline assessment. LOCF imputation was utilized.||percentage of participants|||Number
659037|NCT01890122|Secondary|Percentage of Participants Requiring Hyperglycemic Rescue|Rescue is defined as meeting one of the following criteria, confirmed by a second sample drawn within 7 days of first sample: After >1 week of treatment but prior to Week 4 visit: A single FPG ≥275 mg/dL (≥15.27 mmol/L); From the Week 4 but prior to the Week 8 visit: A single FPG ≥250 mg/dL (≥13.88 mmol/L); From the Week 8 visit but prior to the Week 12 visit: A single FPG ≥225 mg/dL (≥12.49 mmol/L); From the Week 12 visit through the end-of-treatment visit (week 26): HbA1c ≥8.5% and ≤0.5% reduction in HbA1c from baseline.|Baseline up to Week 26|Full analysis set consisted of all randomized participants in the safety set (participants who received at least 1 dose of study drug) who had baseline and at least 1 post baseline assessment. LOCF imputation was utilized.||percentage of participants|||Number
659051|NCT01889667|Secondary|The Effect of ORMD-0801 on Mean Night Time Glucose as Measured by Contiuous Glucose Monitoring (CGM)|Difference between concentration of Nightime Glucose of patients on Placebo and concentration of Nightime Glucose of patients on ORMD-0801|Seven (7) days, and last two days (Day 6 and day 7)|Per Protocol (PP) population, consisting of all study completers with an endpoint of adequate weighted mean nighttime glucose and no major protocol violations||mg/DL||Standard Deviation|Mean
659052|NCT01889667|Primary|Evaluate the Safety and Tolerability of ORMD-0801.|Number of Hypoglycemic events, serious adverse events, and adverse events related to the study drug|Eight (8) days|||Number of Events|||Number
659038|NCT01890122|Secondary|Time to Hyperglycemic Rescue Event|Rescue is defined as meeting one of the following criteria, confirmed by a second sample drawn within 7 days of first sample: After >1 week of treatment but prior to Week 4 visit: A single FPG ≥275 mg/dL (≥15.27 mmol/L); From the Week 4 but prior to the Week 8 visit: A single FPG ≥250 mg/dL (≥13.88 mmol/L); From the Week 8 visit but prior to the Week 12 visit: A single FPG ≥225 mg/dL (≥12.49 mmol/L); From the Week 12 visit through the end-of-treatment visit (week 26): HbA1c ≥8.5% and ≤0.5% reduction in HbA1c from baseline. Time to hyperglycemic rescue was censored if the participant did not experience a hyperglycemic rescue event.|From the date of randomization through Week 26|Randomized set consisted of all enrolled participants who were randomized.||days||Inter-Quartile Range|Median
659039|NCT01890122|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 4, 8, 12, 16, 20 and 26|The change between the FPG value collected at Weeks 4, 8, 12, 16, 20 and 26 relative to baseline. Negative change indicates better glycemic control.|Baseline and Weeks 4, 8, 12, 16, 20 and 26|"Full analysis set consisted of all randomized participants in the safety set (participants who received at least 1 dose of study drug) who had baseline and at least 1 post baseline assessment. LOCF imputation was utilized. n in the category is the number of participants with data available at the given time-point."||mg/dL||Standard Deviation|Mean
659040|NCT01890122|Secondary|Change From Baseline in HbA1c at Weeks 4, 8, 12, 16 and 20|The change in the value of HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Weeks 4, 8, 12, 16 and 20 relative to baseline. Negative change indicates better glycemic control.|Baseline and Weeks 4, 8, 12, 16 and 20|"Full analysis set consisted of all randomized participants in the safety set (participants who received at least 1 dose of study drug) who had baseline and at least 1 post baseline assessment. LOCF imputation was utilized. n in the category is the number of participants with data available at the given time-point."||percentage of glycosylated hemoglobin||Standard Deviation|Mean
659041|NCT01890122|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26 (or Early Termination)|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 26 or early termination relative to baseline. Negative change indicates better glycemic control.|Baseline and Week 26 (or Early termination)|Full analysis set consisted of all randomized participants in the safety set (participants who received at least 1 dose of study drug) who had baseline and at least 1 post baseline assessment. Last observation carried forward (LOCF) imputation was utilized.||percentage of glycosylated hemoglobin||Standard Deviation|Mean
659042|NCT01890031|Secondary|Number of Participants Who Adhered to Medication Prescribed as Self Reported at 9 Months|We will assess adherence (for those who are prescribed a statin in the moderate CVD risk group) by both indirect objective measures and subjective reports. The study design did not include prescription of a cholesterol-lowering medication as per randomization. Participants were prescribed a statin as standard of care based on the participants and physicians agreement. Low risk individuals have less need for medication compared to moderate risk based on the current science.|9 months|||participants|||Number
659043|NCT01890031|Primary|LDL-C in All ICAT Group Participants Versus Non-ICAT Group Participants||9 months|||mg/dL||Standard Deviation|Mean
659044|NCT01889797|Secondary|Progression Free Survival (PFS)|"CT scan every 3 months for 2 years, then every 6 months until progression. Compare PFS in each treatment arm.
Progressive disease (PD) was defined using Cheson criteria as described in the Primary Outcome section above. Progression-free survival (PFS) was defined as the time from start of treatment to the documentation of PD or death, whichever occurs first. Patients alive and without PD were censored at the date of last disease assessment."|Percent of participants alive and progression-free at 1 year|||percentage of participants||80% Confidence Interval|Number
659045|NCT01889797|Secondary|Overall Response Rate|Overall response rate (CR + PR by Cheson criteria) at re-staging (including bone marrow biopsy if CR suspected) by PET and Neck, Chest, Abdomen and Pelvic Computed Tomography (CT) scan. Patients with unevaluable disease were included in the denominator.|Baseline and Re-staging (week 12, 13 or 14)|||percentage of participants||80% Confidence Interval|Number
659046|NCT01889797|Secondary|PET Response Rate|PET response rate [PET-documented CR + Partial Response (PR)] based on PET scan results. Patients with unevaluable disease were included in the denominator.|Re-staging (week 12, 13 or 14)|||participants|||Number
659047|NCT01889797|Primary|Complete Response (CR) Rate|"Positron Emission Tomography (PET)-documented CR rates after induction therapy (weekly treatment x 4 weeks with GA101 or rituximab)
Definitions for clinical response are modified from the Revised Response Criteria for Malignant Lymphoma (Cheson BD, et al. Revised Response Criteria for Malignant Lymphoma. J Clin Oncol 2007; 25(5): 579-86). Lymph node measurements were taken from CT, CT portion of the PET/CT, or MRI scans where applicable. CR is defined as complete disappearance of all evidence of disease; PR as a >50% decrease in the sum of the products of the maximal perpendicular diameters of measured lesions (SPD) and no new sites; SD as failure to attain CR/PR or PD; and PD as any new lesion >1.5cm in any axis or ≥50% increase in previously involved sites."|Re-staging (week 12, 13 or 14) and during follow-up if physician feels patient is subsequently in CR for up to 4 years|All participants were included in the analysis||percentage of participants||80% Confidence Interval|Number
659048|NCT01889667|Secondary|The Effect of ORMD-0801 on Morning Fasting C-peptide Compared to Placebo|Difference between concentration of Morning fasting C-peptide of patients on Placebo and concentration of Morning fasting C-peptide of patients on ORMD-0801|Screening, Day 2, Day 9|Modified intention-to-treat (mITT) population consisting of all randomized patients who took at least one dose of study medication and who had at least one night of CGM monitoring||mg/dL||Standard Deviation|Mean
659049|NCT01889667|Secondary|The Effect of ORMD-0801 on Morning Fasting Serum Insulin|Difference between concentration of Morning fasting serum insulin of patients on Placebo and concentration of Morning fasting C-peptide of patients on ORMD-0801|Screening, Day 2. Day 9|Modified intention-to-treat (mITT) population consisting of all randomized patients who took at least one dose of study medication and who had at least one night of CGM monitoring||mg/dL||Standard Deviation|Mean
659050|NCT01889667|Secondary|The Effect of ORMD-0801 on Mean Daytime Glucose as Measured by Contiuous Glucose Monitoring (CGM)|Difference between concentration of Mean Daytime Glucose of patients on Placebo and concentration of Mean Daytime Glucose of patients on ORMD-0801|Seven (7) days, and last two days (Day 6 and day 7)|Per Protocol (PP) population, consisting of all study completers with an endpoint of adequate weighted mean nighttime glucose and no major protocol violations||mg/dL||Standard Deviation|Mean
659053|NCT01889563|Secondary|Walking Distance on Six Minute Walking Test|Patients underwent the assessments proposed in the study on an outpatient basis before physical exercise training program and after 6 and 12 weeks of physical exercise training program. The second end-point was walking distance on six minute walking test.|Baseline (before physical exercise training program) and after 6 and 12 weeks of physical exercise training program|||meters||Standard Deviation|Mean
659054|NCT01889563|Primary|The SD1 Index, a Nonlinear Index of Heart Rate Variability (HRV)That Represents the Parassimpatetic Activity.|Patients underwent the assessments proposed in the study on an outpatient basis before and after 6 and 12 weeks of physical exercise training program. The primary end-point measure was the SD1, a nonlinear index of HRV that represent the parasympathetic modulation|baseline (before physical exercise training program), 6 and 12 weeks after intervention|||miliseconds||Standard Deviation|Mean
659055|NCT01889420|Secondary|Overall Response Rate (RR)|"ORR is the percentage of patients with a > Partial Response (PR). Response is assessed based on serum protein electrophoresis (SPEP) of the monoclonal protein (M-protein) and plasma concentrations of K/L free light chains (FLC) after each 28-day cycle.
Complete response (CR): disappearance of any M-protein and FLC as measured by SPEP and/or FLC. Pre-existing plasmacytomas must have completely resolved.
PR: >50% reduction in M-protein and >50% reduction in the difference between involved and uninvolved FLC. Any plasmacytoma must have decreased in size by >50%.
Stable disease: not meeting criteria for CR, PR, or progressive disease (PD). PD: >25% increase from baseline in serum or urine M-protein (serum M-protein must increase by > 0.5 gm/dl; urine M-protein must increase by >200 mg /24 hr); or development of new plasmacytomas or new lytic bone lesions; or a measurable increase in the size of these lesions; or hypercalcemia (>11.5 mg/dl) attributed to MM."|3 years|There was only one patient enrolled. Response rates cannot be accurately reported based on one patient.|||||
659056|NCT01889420|Secondary|Anti-tumor Effect|"Anti-tumor effect will be assessed based on serum protein electrophoresis (SPEP) of the monoclonal protein (M-protein) and plasma concentrations of K/L free light chains (FLC) after each 28-day cycle. Descriptive statistics will be used for this measurement.
Complete response (CR): disappearance of any M-protein and FLC as measured by SPEP and/or FLC. Pre-existing plasmacytomas must have completely resolved.
Partial response (PR): >50% reduction in M-protein and >50% reduction in the difference between involved and uninvolved FLC. Any plasmacytoma must have decreased in size by >50%.
Stable disease: not meeting criteria for CR, PR, or progressive disease (PD). PD: >25% increase from baseline in serum or urine M-protein (serum M-protein must increase by > 0.5 gm/dl; urine M-protein must increase by >200 mg /24 hr); or development of new plasmacytomas or new lytic bone lesions; or a measurable increase in the size of these lesions; or hypercalcemia (>11.5 mg/dl) attributed to MM."|3.5 years|There was only one patient enrolled. Anti-tumor effect cannot be reported accurately based on results from one patient.|||||
659057|NCT01889420|Secondary|Toxicity Profile|The toxicity profile will be described by specific adverse event rates among patients experiencing > grade 3 hematologic events (lasting >7 days) or grades 3-5 non-hematologic adverse events, according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, over a 28 day cycle. Specific events will be described as the numbers of patients experiencing them within each treatment cohort.|2 years||||||
659058|NCT01889420|Primary|Maximum Tolerated Dosage (MTD)(Phase I)|The Maximum Tolerated Dose (MTD) will be determined by first identifying the dose level at which >= 30% of patients experience a Dose Limiting Toxicity (DLT) according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, over a 28 day cycle. DLT will be defined based on the rate of drug-related grade 3-5, non-hematological adverse events experienced within the first 4 weeks (1 cycle) for each combined dosage scheme. The MTD will be defined as one dosage level below which DLT was observed in >= 30% of patients.|2 years|There was only one patient enrolled. The MTD could not be calculated based on one patient.|||||
659059|NCT01889251|Primary|Proportion of Subjects With Non-Surgical Resolution of Vitreomacular Adhesion (VMA)|VMA (adhesion of the vitreous gel to the retina in an abnormally strong manner) was determined by masked Central Reading Center (CRC) Spectral Domain Optical Coherence Tomography (SD-OCT) evaluation. Only one eye (study eye) was analyzed. Proportion of subjects is reported as a percentage.|Day 28|This analysis population includes all subjects who received study medication, completed at least 1 on-therapy study visit and had symptomatic VMA at baseline, as randomized, based on an intent to treat approach.||percentage of subjects|||Number
659060|NCT01888965|Secondary|Safety|Percent of subjects who experience grade 3/ 4 adverse events|2 years|Patients had either Stage 4 Colon Cancer, post-metastasectomy; Stage 4 Colon Cancer post-initial chemotherapy; Pancreas Cancer, post-resection and adjuvant chemo; or Locally advanced pancreas cancer post-chemo and radiation.||percentage of participants|||Number
659061|NCT01888965|Secondary|Progression-free Survival|"Time in days from study entry until disease progression or death
Disease progression was defined according to RECIST as at least a 20% increase in the sum of the longest diameter of the target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started, or the appearance of one or more new lesions"|2 years|Patients had either Stage 4 Colon Cancer, post-metastasectomy; Stage 4 Colon Cancer post-initial chemotherapy; Pancreas Cancer, post-resection and adjuvant chemo; or Locally advanced pancreas cancer post-chemo and radiation.||days||Full Range|Median
659062|NCT01888965|Primary|Biomarker Discovery|Changes in biomarkers from before treatment compared to during or after treatment: expression of pFGFR, pFRS2, pERK, BFGF, VEGF, FGFR1, FGFR2,VEGFR, Ki-67, Asp175, and CA9 in tumor tissue; FGFR, VEGFs, BFGF, PLGF, sVEGFR1/ 2, FGF23, GCSF, PDGF-AB, SDF-1a and SCF levels in serum|2 years|Data cannot be summarized in the data table because biomarker analysis did not take place after study closure due to insufficient number of samples to yield significant results related to dovitinib administration. Instead, collected samples are stored in our biobank, as consented by all patients, for future Oncological analyses of importance.|||||
659063|NCT01888952|Primary|Total Number of Adverse Events.|Adverse events were listed using CTCAE Version 4.03 (Common Terminology Criteria for Adverse Events) toxicity grade.|Average of 21 days.|||Adverse events|||Number
659064|NCT01888900|Secondary|Rates of Asunaprevir and Daclatasvir Resistance||post treatment|||Participants|||Count of Participants
659065|NCT01888900|Secondary|Virological Relapse|HCV RNA >= LLOQ level after therapy is stopped in a patient who previously achieved an end-of-treatment virological response|beyond Week 24 post treatment|||Participants|||Count of Participants
659066|NCT01888900|Secondary|Serum Aminotransferase Levels|whether raw ALT value is in normal range which is less than 41 U/L.|Week 12 post treatment|||Participants|||Count of Participants
659071|NCT01888900|Primary|Changes in Interferon Stimulated Genes in the Liver|"Change in raw expression in interferon stimulated genes at week 2 or 4 compared to baseline is obtained by subtracting either 2 or 4 week measurement from baseline measurement. Negative values reflect a decrease in expression and positive values reflect an increase in expression.
The raw gene expression data was normalized using quantile normalization based on all the genes in the microarray."|baseline and either 2 or 4 weeks|one patient in genotype 1A arm was not included in primary outcome data collection due to late enrollment.||relative expression||Inter-Quartile Range|Median
659072|NCT01888367|Secondary|Cumulative ASEPSIS Score for Each Patient|Total ASEPSIS score with a range of 0-65 points with lower scores being better. The score is the sum of: Antibiotic Use (10 points), Drainage of Pus Under Local Anesthesia (5 points), Debridement Under General Anesthesia (10 points), Serous Discharge (5 points), Erythema (5 points), Purulent Exudate (5 points), Separation of Deep Tissues (10 points) and Isolation of Bacteria from Discharge (10 points). Source: Wilson AP, Treasure T, Sturridge MF, Gruneberg RN. Lancet. 1986:1(8476):311-3.|Through post-operative Day 4|"Safety analyses were as treated so patients who were randomized to gel but did not receive it are counted as SOC. For 4 patients, the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized."||units on a scale||Standard Deviation|Mean
659073|NCT01888367|Secondary|Change in Serum Creatinine Measurements From Baseline|Change from baseline in micromoles/liter|Within 4 days of surgery|"402 of the 445 patients had both baseline and post-operative creatinine measurements. Safety analyses were as treated so patients randomized to gel but did not receive it in surgery were counted in the SOC group."||micromoles/liter||Standard Deviation|Mean
659074|NCT01888367|Secondary|Number of Patients With Adverse Events||Within 30 days of surgery|"The safety analysis was as treated. For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the patients who did not receive gel were counted in the SOC group."||participants|||Number
659075|NCT01888367|Primary|Number of Patients With Surgical Site Infections||Within 30 days of surgery|The number of SSIs from the day of surgery to 30 days post-op could only be assessed in the 427 completed patients. Central adjudication by the Clinical Events Committee was not able to assess the presence or absence of SSI for two patients, one in the DFA-02 group and one in the SOC group so the total analyzed is only 425.||participants|||Number
659076|NCT01888003|Primary|Number of Subjects Requiring Blood Transfusions Post Hospital Discharge Through 90 Days After Surgery|number of subjects requiring blood transfusions after hospital discharge through 90 days after surgery|post hospital discharge through 90 days after surgery|Subjects dropped out of study prior to day 90|||||
659077|NCT01888003|Primary|Number of Subjects With Blood Transfusions After Surgery and Prior to Discharge From Hospital|Number of subjects that had at least 1 blood transfusion from the end of surgery until discharge from hospital|post surgery through discharge, an average of 2 days|||participants|||Number
659078|NCT01888003|Secondary|Health-related Quality of Life|Health-related quality of life measured with the SF-12V2; Western Ontario and McMaster University Osteoarthritis Index (WOMAC) Questionnaire; Oxford Hip Score or Oxford Knee Score; and Multidimensional Assessment of Fatigue (MAF) Scale|Baseline at 14 days before, on hospital discharge, and at two-weeks, 30 days, 60 days and 90 days after surgery|No subject data was analyzed.|||||
659079|NCT01888003|Primary|Number of Subjects Requiring at Least One Blood Transfusion During Surgery.|The number of subjects who had blood transfusions (at least 1) during surgery|During surgery (less than 1 day)|||Participants|||Number
659080|NCT01887990|Secondary|Depression|Scales and Questionnaire using the MADRS (Montgomery-Asberg Depression Rating Scale) . This is a ten item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. the scale: 0 - 6 (normal/symptom absent), 7 - 19 (mild depression), 20 - 34 (moderate depression), and > 34 (severe depression).The overall score ranges from 0 to 60|2 hours|||units on a scale||Standard Deviation|Mean
659081|NCT01887990|Primary|Suicidality|"Scales and questionnaires using the Beck Scale for Suicidal Ideation. The Beck Scale is a self-report questionnaire. The items on this scale identify the presence and severity of suicidal ideation.
Beck Scale for Suicidal Ideation has 19 items,preceded by a 5 item screener. Each item is rated on a 3 point scale from 0 to 2. Scores range from 0 to 48. Total scoreScores of 0 - 16 indicate low risk for suicide; scores of 16 or greater indicate higher risk for suicide."|2 hours|||units on a scale||Standard Deviation|Mean
659082|NCT01887678|Secondary|Time to and Use of Rescue Medication (Acetaminophen up to 3000 mg Per Day for Breakthrough Pain) (Study Population Measure Statistically Derived). Tablets Taken.|Time to and use of rescue medication (acetaminophen up to 3000 mg per day for breakthrough pain) (study population measure statistically derived). Total number of tablets taken as reported by patient.|Statistically derived|119 patients were randomized to Traumeel/Zeel and 113 to Placebo and all were included in the Safety Set. Two patients in each group could not be evaluated for primary efficacy. 117 patients in Traumeel/Zeel and 111 patients in Placebo formed the Full Analysis - efficacy. For missing values, Last-observation carried forward (LOCF) was used.||Tablets||Standard Deviation|Mean
659083|NCT01887678|Secondary|Time to and Use of Rescue Medication (Acetaminophen up to 3000 mg Per Day for Breakthrough Pain) (Study Population Measure Statistically Derived) - Patients Use|Time to and use of rescue medication (acetaminophen up to 3000 mg per day for breakthrough pain) as reported by the patients. Patients who used any rescue medication during the study.|Statistically derived|119 patients were randomized to Traumeel/Zeel and 113 to Placebo and all were included in the Safety Set. Two patients in each group could not be evaluated for primary efficacy. 117 patients in Traumeel/Zeel and 111 patients in Placebo formed the Full Analysis - efficacy. For missing values, Last-observation carried forward (LOCF) was used.||participants|||Number
659104|NCT01887470|Secondary|Tolerability of and Preference for Lactulose as a Bowel Evacuant|"Survey response to question: Would you be willing to repeat this preparation if a colonoscopy was felt to be medically necessary at some point in the future? The outcome measure is reporting the percentage of participants who replied Yes to this survey question."|3 - 15 hours post last consumption|The study objectives in the protocol called for patient tolerability to be evaluated for all treatment participants. Therefore, outcome measures are not displayed with respect to the four individual treatment groups.||Percentage of Participants|||Number
659084|NCT01887678|Secondary|Patients Achieving 100% Pain Relief|Changes of the target (treated) knee pain following a 50 feet walk self-assessed by the patients on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0 corresponded to 'None' and 100 to 'Extreme'. The time to 100% pain relief were statistical exercises and were analyzed for each individual patient from their self-assessment, however, the prevalence of 100% pain relief did not support an estimate for the median time. The number of patients who reached 100% pain relief is reported and the log rank test for difference in time to 100% pain relief was calculated for each injection.|Statistically derived|119 patients were randomized to Traumeel/Zeel and 113 to Placebo and all were included in the Safety Set. Two patients in each group could not be evaluated for primary efficacy. 117 patients in Traumeel/Zeel and 111 patients in Placebo formed the Full Analysis - efficacy. For missing values, Last-observation carried forward (LOCF) was used.||participants|||Number
659085|NCT01887678|Secondary|Time to 50% Pain Relief (Study Population Measure Statistically Derived)|Changes of the target (treated) knee pain following a 50 feet walk self-assessed by the patients on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0 corresponded to 'None' and 100 to 'Extreme'. The time to 50% pain relief were statistical exercises and were analyzed for each individual patient from their self-assessment.|Statistically derived|119 patients were randomized to Traumeel/Zeel and 113 to Placebo and all were included in the Safety Set. Two patients in each group could not be evaluated for primary efficacy. 117 patients in Traumeel/Zeel and 111 patients in Placebo formed the Full Analysis - efficacy. For missing values, Last-observation carried forward (LOCF) was used.||days||95% Confidence Interval|Median
659086|NCT01887678|Other Pre-specified|Proportion of Patients Who Discontinued Due to an AE|Total number of patients affected.|All visits (Days 1 up to 119)|119 patients were randomized to Traumeel/Zeel and 113 patients to Placebo and all randomized patients were included in the Safety Set. Medical Dictionary for Regulatory Activities (MedDRA) Version 16.0 terminology.||participants|||Number
659087|NCT01887678|Other Pre-specified|Incidence of Treatment Emergent Adverse Events (TEAEs)|Total number of patients affected.|during the treatment period and follow up period (Days 11 to 119)|119 patients were randomized to Traumeel/Zeel and 113 patients to Placebo and all randomized patients were included in the Safety Set. MedDRA Version 16.0 terminology. Adverse events during treatment (treatment-emergent) in 5% or more of total study patients||participants|||Number
659088|NCT01887678|Other Pre-specified|Each Adverse Event (AE)|Total number of patients affected.|Starting at Visit 2/ Start of Lead-In period (Day 7 up to day 119)|119 patients were randomized to Traumeel/Zeel and 113 patients to Placebo and all randomized patients were included in the Safety Set. 8 patients without any injection (not randomized) reported 12 adverse events||participants|||Number
659089|NCT01887678|Other Pre-specified|Serious Adverse Events|Total number of patients affected.|Start of Lead-In period until individual study end, up to 16 weeks.|119 patients were randomized to Traumeel/Zeel and 113 patients to Placebo and all randomized patients were included in the Safety Set. MedDRA Version 16.0 terminology||participants|||Number
659090|NCT01887678|Secondary|Time to Walking (50-foot Walk Test)|Changes in time to walk 50 feet (seconds)|Baseline (Day 1, predose) to post-Baseline visits (up to day 119)|119 patients were randomized to Traumeel/Zeel and 113 to Placebo and all were included in the Safety Set. Two patients in each group could not be evaluated for primary efficacy. 117 patients in Traumeel/Zeel and 111 patients in Placebo formed the Full Analysis - efficacy. For missing values, Last-observation carried forward (LOCF) was used.||seconds||Standard Deviation|Mean
659091|NCT01887678|Secondary|Pain Immediately Following the 50-foot Walk (100 mm VAS)|Changes of the target (treated) knee pain following a 50 feet walk self-assessed by the patients on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0 corresponded to ‘None’ and 100 to ‘Extreme’.|Baseline (Day 1, predose) to post-Baseline visits (up to day 119)|119 patients were randomized to Traumeel/Zeel and 113 to Placebo and all were included in the Safety Set. Two patients in each group could not be evaluated for primary efficacy. 117 patients in Traumeel/Zeel and 111 patients in Placebo formed the Full Analysis - efficacy. For missing values, Last-observation carried forward (LOCF) was used.||units on a scale||Standard Deviation|Mean
659092|NCT01887678|Secondary|Physician Global Assessment (PhGA)|Study Physicians made an overall Global Assessment of the knee osteoarthritis with the assessment stages “Very good”, “Good”, “Fair”, “Poor” and “Very poor”.|End of Study Visit (up to Day 119)|119 patients were randomized to Traumeel/Zeel and 113 to Placebo and all were included in the Safety Set. Two patients in each group could not be evaluated for primary efficacy. 117 patients in Traumeel/Zeel and 111 patients in Placebo formed the Full Analysis - efficacy. For missing values, Last-observation carried forward (LOCF) was used.||participants|||Number
659093|NCT01887678|Secondary|Physician Global Assessment (PhGA)|Study Physicians made an overall Global Assessment of the knee osteoarthritis with the assessment stages “Very good”, “Good”, “Fair”, “Poor” and “Very poor”.|Baseline (Day 1, predose)|119 patients were randomized to Traumeel/Zeel and 113 to Placebo and all were included in the Safety Set. Two patients in each group could not be evaluated for primary efficacy. 117 patients in Traumeel/Zeel and 111 patients in Placebo formed the Full Analysis - efficacy. For missing values, Last-observation carried forward (LOCF) was used.||participants|||Number
659094|NCT01887678|Secondary|Patient Global Assessment (PGA)|Patients made an overall Global Assessment of the knee osteoarthritis with the assessment stages “Very good”, “Good”, “Fair”, “Poor” and “Very poor”.|End of Study Visit (up to Day 119)|119 patients were randomized to Traumeel/Zeel and 113 to Placebo and all were included in the Safety Set. Two patients in each group could not be evaluated for primary efficacy. 117 patients in Traumeel/Zeel and 111 patients in Placebo formed the Full Analysis - efficacy. For missing values, Last-observation carried forward (LOCF) was used.||participants|||Number
659095|NCT01887678|Secondary|Patient Global Assessment (PGA)|Patients made an overall Global Assessment of the knee osteoarthritis with the assessment stages “Very good”, “Good”, “Fair”, “Poor” and “Very poor”.|from Baseline (Day 1, predose)|119 patients were randomized to Traumeel/Zeel and 113 to Placebo and all were included in the Safety Set. Two patients in each group could not be evaluated for primary efficacy. 117 patients in Traumeel/Zeel and 111 patients in Placebo formed the Full Analysis - efficacy. For missing values, Last-observation carried forward (LOCF) was used.||participants|||Number
660801|NCT01852955|Primary|Quality of Recovery at 24 Hours(QoR-40 Instrument)|Quality of recovery score 24 hours after the surgical procedure. Total score range of 40 (poor recovery) and a score of 200 (good recovery).|24 hours after the surgical procedure|||units on a scale||Inter-Quartile Range|Median
659096|NCT01887678|Secondary|Total WOMAC Score (All Subscales) Recorded on 100 mm VAS|Changes of the target (treated) knee were assessed using the Western Ontario and McMaster Universities Osteoarthritis Index version 3.1 (WOMAC OA) whereby patients self-assessed 24 parameters on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0 corresponded to ‘None’ and 100 to ‘Extreme’. A total WOMAC score was computed by averaging all 24 possible responses. At Study Days 1, 8 and 15 where injections were administered, this was to be done before injection. Changes in total WOMAC score were analyzed by using an analysis of covariance (ANCOVA) model with treatment group as qualitative factor and Baseline value as a covariate.|from Baseline (Day 1, predose) to End of Study Visit (up to Day 119)|119 patients were randomized to Traumeel/Zeel and 113 to Placebo and all were included in the Safety Set. Two patients in each group could not be evaluated for primary efficacy. 117 patients in Traumeel/Zeel and 111 patients in Placebo formed the Full Analysis - efficacy. For missing values, Last-observation carried forward (LOCF) was used.||units on a scale||Standard Deviation|Mean
659097|NCT01887678|Secondary|Physical Function Bubscore (WOMAC Section C, Items #8-24) Recorded on 100 mm VAS|Changes of the target (treated) knee were assessed using the Western Ontario and McMaster Universities Osteoarthritis Index version 3.1 (WOMAC OA) whereby patients self-assessed 24 parameters on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0 corresponded to ‘None’ and 100 to ‘Extreme’. To assess physical function, scores from WOMAC Section C, items 8 to 24 are averaged to yield the Physical Function Subscale total score. At Study Days 1, 8 and 15 where injections were administered, this was to be done before injection. Changes in Physical Function subscore were analyzed by using an analysis of covariance (ANCOVA) model with treatment group as qualitative factor and Baseline value as a covariate.|from Baseline (Day 1, predose) to End of Study Visit (up to Day 119)|119 patients were randomized to Traumeel/Zeel and 113 to Placebo and all were included in the Safety Set. Two patients in each group could not be evaluated for primary efficacy. 117 patients in Traumeel/Zeel and 111 patients in Placebo formed the Full Analysis - efficacy. For missing values, Last-observation carried forward (LOCF) was used.||units on a scale||Standard Deviation|Mean
659098|NCT01887678|Secondary|Stiffness Subscore (WOMAC Section B, Items #6-7) Measured by 100 mm VAS|Changes of the target (treated) knee were assessed using the Western Ontario and McMaster Universities Osteoarthritis Index version 3.1 (WOMAC OA) whereby patients self-assessed parameters on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0 corresponded to ‘None’ and 100 to ‘Extreme’. To assess stiffness, scores from WOMAC Section B, items 6 to 7 are averaged to yield the Stiffness Subscale total score. At Study Days 1, 8 and 15 where injections were administered, this was to be done before injection. Changes in stiffness score were analyzed by using an analysis of covariance (ANCOVA) model with treatment group as qualitative factor and Baseline value as a covariate.|from Baseline (Day 1, predose) to End of Study Visit (up to Day 119)|119 patients were randomized to Traumeel/Zeel and 113 to Placebo and all were included in the Safety Set. Two patients in each group could not be evaluated for primary efficacy. 117 patients in Traumeel/Zeel and 111 patients in Placebo formed the Full Analysis - efficacy. For missing values, Last-observation carried forward (LOCF) was used.||units on a scale||Standard Deviation|Mean
659099|NCT01887678|Secondary|Pain Subscore (WOMAC Section A, Items #1-5) Measured by 100 mm VAS|Changes of the target (treated) knee were assessed using the Western Ontario and McMaster Universities Osteoarthritis Index version 3.1 (WOMAC OA) whereby patients self-assessed 24 parameters on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0 corresponded to ‘None’ and 100 to ‘Extreme’. To assess pain, scores from WOMAC Section A, items 1 to 5 are averaged to yield the Pain Subscale total score. At Study Days 1, 8 and 15 where injections were administered, this was to be done before injection. Changes in pain subscore were analyzed by using an analysis of covariance (ANCOVA) model with treatment group as qualitative factor and Baseline value as a covariate.|from Baseline to post-Baseline visits except End of Study Visit (up to day 105)|119 patients were randomized to Traumeel/Zeel and 113 to Placebo and all were included in the Safety Set. Two patients in each group could not be evaluated for primary efficacy. 117 patients in Traumeel/Zeel and 111 patients in Placebo formed the Full Analysis - efficacy. For missing values, Last-observation carried forward (LOCF) was used.||units on a scale||Standard Deviation|Mean
659100|NCT01887678|Primary|Change in Knee Pain as Measured by the WOMAC Osteoarthritis (OA) Index Pain Subscale (Section A, Items #1-5) Measured by 100 mm VAS|Changes of the target (treated) knee were assessed using the Western Ontario and McMaster Universities Osteoarthritis Index version 3.1 (WOMAC OA) whereby patients self-assessed 24 parameters on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0 corresponded to ‘None’ and 100 to ‘Extreme’. To assess pain, scores from WOMAC Section A, items 1 to 5 are averaged to yield the Pain Subscale total score. At Study Days 1, 8 and 15 where injections were administered, this was to be done before injection. A two-sided test of equality of the study drug (Traumeel®-Zeel®) and Placebo at level 0.05 was computed using an analysis of covariance (ANCOVA) model with treatment group as qualitative factor and the corresponding Baseline value of the primary efficacy variable as a covariate. The test decision was based on the (two-sided) p-value for the corresponding test of no treatment difference.|from Baseline (Day 1, predose) to End of Study Visit (up to Day 119)|119 patients were randomized to Traumeel/Zeel and 113 to Placebo and all were included in the Safety Set. Two patients in each group could not be evaluated for primary efficacy. 117 patients in Traumeel/Zeel and 111 patients in Placebo formed the Full Analysis - efficacy. For missing values, Last-observation carried forward (LOCF) was used.||units on a scale||Standard Deviation|Mean
659101|NCT01887470|Secondary|Colonic Methane Gas Levels||3 - 15 hours post last consumption|A secondary objective in the protocol called for colonic gas levels to be measured for all treatment participants. Therefore, outcome measures are not displayed with respect to the four individual treatment groups.||parts per million by volume||Full Range|Mean
659102|NCT01887470|Secondary|Colonic Hydrogen Gas Levels||3 - 15 hours post last consumption|A secondary objective in the protocol called for colonic gas levels to be measured for all treatment participants. Therefore, outcome measures are not displayed with respect to the four individual treatment groups.||parts per million by volume||Standard Deviation|Mean
659103|NCT01887470|Secondary|Tolerability of and Preference for Lactulose as a Bowel Evacuant|"Survey response to question: if you had a previous colonoscopy, please indicate your preference for the crystalline lactulose or the previous medications."|3 to 15 hours post last consumption|Of the 40 participants responding to the patient questionnaire, only 21 reported that they had had a previous colonoscopy; therefore, the other 19 are not included in this outcome measure.||percentage of participants|||Number
659105|NCT01887470|Secondary|Tolerability of and Preference for Lactulose as a Bowel Evacuant-Likert 3|"Tolerability assessed by a patient questionnaire - Likert response to The dosing instructions were easy to understand and follow Range of responses allowed include whole numbers between 1 and 7. The following guide was given to the patients: 1 = Strongly Disagree; 4 = Neutral; 7 = Strongly Agree"|3 - 15 hours post last consumption|The study objectives in the protocol called for patient tolerability to be evaluated for all treatment participants. Therefore, outcome measures are not displayed with respect to the four individual treatment groups.||units on Likert Scale||Standard Deviation|Mean
659106|NCT01887470|Secondary|Tolerability of and Preference for Lactulose as a Bowel Evacuant-Likert 2|"Tolerability assessed by a patient questionnaire - Likert response to I did not experience too much discomfort during the bowel prep Range of responses allowed include whole numbers between 1 and 7. The following guide was given to the patients: 1 = Strongly Disagree; 4 = Neutral; 7 = Strongly Agree"|3-15 hours post last consumption|The study objectives in the protocol called for patient tolerability to be evaluated for all treatment participants. Therefore, outcome measures are not displayed with respect to the four individual treatment groups.||units on Likert Scale||Standard Deviation|Mean
659107|NCT01887470|Secondary|Tolerability of and Preference for Lactulose as a Bowel Evacuant-Likert 1|"Tolerability assessed by a patient questionnaire - Likert response to was regimen a tolerable bowel prep? Range of responses allowed include whole numbers between 1 and 7. The following guide was given to the patients: 1 = Strongly Disagree; 4 = Neutral; 7 = Strongly Agree"|3-15 hours post last consumption|The study objectives in the protocol called for patient tolerability to be evaluated for all treatment participants. Therefore, outcome measures are not displayed with respect to the four individual treatment groups.||units on Likert Scale||Standard Deviation|Mean
659108|NCT01887470|Secondary|Tolerability of and Preference for Lactulose as a Bowel Evacuant-Patient Visual Analog Scale (VAS)|"A paper questionnaire contained a horizontal line 100 mm long with the right end labeled Best Possible Experience and the left end labeled Worst Possible Experience. The patients were asked to use a pen to place a mark on the line at the point that best described their overall tolerability for the bowel preparation.
Scores were determined by measuring the distance of the mark from the left end of the line. So, a lower number would indicate a poor experience and a high number would reflect a positive experience, with 100 being the maximum score and one that describes the best possible experience with the preparation."|3 - 15 hours post last consumption|The study objectives in the protocol called for patient tolerability to be evaluated for all treatment participants. Therefore, outcome measures are not displayed with respect to the four individual treatment groups.||units on VAS scale||Standard Deviation|Mean
659109|NCT01887470|Secondary|Incidence of Treatment Failure|A treatment failure is defined in the protocol as a bowel preparation that receives a cumulative Boston Bowel Preparation Score less than 5, or has one or more of the segments scored as a 0.|at least 3 hours post last consumption|The study objectives in the protocol called for the incidence of treatment failures to be calculated from the pooled data of all treatment participants. Therefore, outcome measures are not displayed with respect to individual treatment groups.||participants|||Number
659110|NCT01887470|Primary|Efficacy of Lactulose as a Preparation for Colonoscopy.|"Efficacy assessed by the physician’s determination of the cleanliness of the colon using the cumulative Boston Bowel Preparation Scale (BBPS) score. The cumulative score is derived from three segmental scores assessed from the following three colonic segments: right colon, transverse colon, and left colon. Segment scores range from 0 to 3 with the following abbreviated definitions: 0=mucosa not visible; 1=a portion of the mucosa is visible; 2=minor residue, but mucosa is seen well; 3=entire mucosa is seen well with no residue.
The cumulative BBPS score is the sum of the three segment scores such that a cumulative score of 9 represents a colon with maximum mucosa visible and a score of 0 represents minimal visibility."|at least 3 hours post last consumption|||units on a scale||Standard Deviation|Mean
659111|NCT01887418|Primary|The Average Concentration [Cavg] of Testosterone Enanthate Formulations at 6 Weeks|The average concentration [Cavg] of TE administered by SC injection once weekly at doses of 50 mg and 100 mg via the QST|0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post-dose, at 6 Weeks|PK profile of TT obtained at Week 6 of treatment by QST||ng/dL||Standard Deviation|Mean
659112|NCT01887418|Primary|The Maximum Plasma Concentration [Cmax] of Testosterone Enanthate Formulations at 6 Weeks|The maximum observed plasma concentration [Cmax] of TE administered by SC injection once weekly at doses of 50 mg and 100 mg via the QST|0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post-dose, at 6 Weeks|PK profile of TT obtained at Week 6 of treatment by QST||ng/dL||Standard Deviation|Mean
659113|NCT01887418|Primary|The Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of Testosterone Enanthate Formulations at 6 Weeks|The area under the curve from time zero to last quantifiable concentration [AUC (0-t)] of TE administered by SC injection once weekly at doses of 50 mg and 100 mg via the QST|0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post-dose, at 6 Weeks|PK profile of TT obtained at Week 6 of treatment by QST||ng*hr/dL||Standard Deviation|Mean
659114|NCT01887418|Secondary|Number of Patients in the PK Parameter Category|The number of TT Cavg (0-168h) values within the normal range (300-1100 ng/dL) following treatment with SC TE administered via QST or IM TE|6 weeks|||participants|||Number
659115|NCT01887353|Primary|Time to First Atrial Fibrillation (AF) Recurrence|There were too few participants for an assessment of time to first recurrence, therefore the numbers of participants with recurrence up to 6 months is reported instead|up to 6 months|||participants|||Number
659116|NCT01887171|Secondary|Postreperfusion Hyperfibrinolysis|"Protocol is restricted to liver transplants performed with classic technique with sequential portal-arterial reperfusion.
Peripheral blood samples will be taken 15 min and 2 hours after portal reperfusion.
Hyperfibrinolysis will be diagnosed by Thromboelastometry (ROTEM) if one or more following criteria are met:
LI30<85% or ML>15% or LI60<85% or A10 in Extem is by 15% is less then A10 in Aptem."|15 min and 2 hours after portal reperfusion||||||
659137|NCT01886690|Secondary|Change From Baseline in Uncorrected Visual Acuity in the Worse Eye|Uncorrected visual acuity in the worse eye is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) without corrective lenses. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive number change from baseline in the number of letters read correctly indicates an improvement and a negative number change from baseline indicates a worsening.|Baseline, Day 90|Per Protocol: all randomized patients who had no significant protocol violations and who had data at the noted time point||Letters Read Correctly||Standard Deviation|Mean
659117|NCT01887171|Secondary|Inflammatory Response to Reperfusion|"Protocol is restricted to liver transplants performed with classic technique with sequential portal-arterial reperfusion.
After unclamping portal vein but before unclamping the inferior vena cava and after venting of first 100 ml of blood a 5 ml sample of blood (code is HV) from a tube inserted into caval suture line will be taken. Another 5 ml sample of blood (code is C) will be taken by puncture of one of hepatic veins 20 min later. Samples (5 ml each) of peripheral blood will be taken on 1st and 3d postoperative day (POD). P-selectin, interleukin-6, interleukin-8, tumor necrosis factor alfa (TNF-a) and macrophage inflammatory protein 1 alpha (MIP-1a) will be determined in samples HV and C. Interleukin-8, elastase, TNF-a and vascular endothelial growth factor (VEGF) will be determined in samples of 1st and 3d POD."|0 and 20 min after portal reperfusion, 1 and 3 postoperative day||||||
659118|NCT01887171|Secondary|Ischemic Reperfusion Injury of the Liver Allograft|"Protocol is restricted to liver transplants performed with classic technique with sequential portal-arterial reperfusion.
A wedge resection of small (5x5mm) part of liver segment-III will be sampled at 2 hours after venous reperfusion. Rate of necrosis, inflammation, vascular thrombosis, cluster of differentiation (CD) 68 and High mobility group box 1 protein (HMGB1) staining will be assessed thereafter."|liver biopsy taken at 2 hours after portal reperfusion||||||
659119|NCT01887171|Primary|Early Allograft Dysfunction|"Protocol is restricted to liver transplants performed with classic technique with sequential portal-arterial reperfusion.
Early allograft dysfunction will be assessed on the basis of highest levels of AST and ALT during 1-7 postoperative days."|1-7 postoperative days after liver transplant procedure|||Participants|||Count of Participants
659120|NCT01887132|Other Pre-specified|Vineland Parent Questionnaire at 3, 6, 12 and 18 Months||3, 6, 12 and 18 months||||||
659121|NCT01887132|Other Pre-specified|Autism Diagnostic Observation Schedule (ADOS) at 6, 12 and 18 Months||6, 12 and 18 months||||||
659122|NCT01887132|Other Pre-specified|Mullen Scales at 18 Months||18 months||||||
659123|NCT01887132|Other Pre-specified|An Exploratory Analysis Will Investigate Whether Normalization of REM Parameters Also Improves Other Measurements of Sleep Quality in Children With Autism.||12 months||||||
659124|NCT01887132|Secondary|REM Percentage at Baseline, 6, 12 and 18 Months|REM percentage is the percentage of sleep spent in REM|Baseline, 6, 12 and 18 months|||percentage of sleep|||Number
659125|NCT01887132|Primary|Nonverbal Developmental Quotient (NVDQ)|"The Nonverbal Developmental Quotient (NVDQ) was calculated from the Mullen Scales of Early Learning scores by dividing the nonverbal mental age (average of the age equivalent value for the Visual Reception and Fine Motor scores) by the chronological age in months. The NVDQ is normalized to a mean score of 100, which indicates an average normal IQ. Less than 100 is a lower than average IQ. 2 standard deviations below average is considered impaired IQ (approximately lower than 70)."|Baseline and 12 months|||units on a scale|||Number
659126|NCT01886963|Primary|Wound Complication|breakdown, necrosis, erythema, infection, or dehiscence with location specified|12 Weeks|||participants|||Number
659127|NCT01886937|Primary|Food Intake|The primary outcome measure is food intake assessed by laboratory meal study after one week of phentermine administration compared to one week of placebo administration.|one week|This is a cross over design study. All participants received phentermine and placebo.The phentermine arm listed here includes all participants who received phentermine (regardless of whether they received it first or second). The placebo arm includes all those who received placebo (regardless of whether they received placebo first or second).||kcal||Standard Deviation|Mean
659128|NCT01886807|Secondary|Blood Loss||At the completion of intubation||||||
659129|NCT01886807|Secondary|Intubation Duration||From start of intubation attempt to completion of intubation||||||
659130|NCT01886807|Secondary|Blood Pressure||From start of intubation attempt to completion of intubation||||||
659131|NCT01886807|Secondary|Heart Rate||From start of intubation attempt to completion of intubation||||||
659132|NCT01886807|Primary|Time to 1% Saturation Drop|Kaplan-Meyer estimate 25th percentile along with adjusted 95% confidence limits were reported instead of usual 50th percentile (median) since there was not enough non-censored data for the DLO2 group (not many patients dropped 1% in SO2 from their baseline )|From beginning to end of laryngoscopy|||seconds||95% Confidence Interval|Median
659133|NCT01886807|Primary|Oxygen Saturation|In the primary hypothesis, desaturation will be characterized using both time to 1% saturation drop from the baseline and the rate (slope) of desaturation after an initial 1% drop.We will consider a given intubation technique (DLO2 or VL) better than DL on controlling saturation if found noninferior (i.e., not worse) on both outcomes and superior on at least one of the outcome.|From start of intubation attempt to completion of intubation||||||
659134|NCT01886781|Primary|A Change in Abdominal Pain Severity|The clinical severity of the IBS symptoms (pain and distension) was evaluated by the Francis Severity Score questionnaire (Francis 1997). The questionnaire is a validated tools for use in IBS. The severity score contained five questions, each given a value from 0 (no symptoms) to 100 (most severe) for measuring the severity and frequency of abdominal pain. The sum of scores of these questions was considered the severity score, with a maximum possible score of 500|Total trial period 12 weeks|||units on a scale||Standard Deviation|Mean
659135|NCT01886716|Primary|The Daily Drinking Questionnaire|The Daily Drinking Questionnaire (Collins, Parks, & Marlatt, 1985) was the primary measure used to assess weekly alcohol consumption. This calendar-based measure was administered by the experimenter once per week to monitor changes in symptoms. The measure assessed the total number of drinks in the past week.|Baseline, weekly throughout the 4-week trial, and in the follow-up sessions (1 week and 1 month follow-ups)|||number of drinks||Standard Deviation|Mean
659136|NCT01886716|Primary|Liebowitz Social Anxiety Scale|The experimenter-administered Liebowitz Social Anxiety Scale (Liebowitz, 1987) was the primary measure to assess social anxiety symptoms. This well-validated instrument assesses fear and avoidance across a range of 24 social and performance situations during the course of the previous week. A total LSAS score was computed, ranging from 0 (no fear or avoidance) to 144 (the greatest level of fear and avoidance).|Baseline, weekly throughout the 4-week trial, and in the follow-up sessions (1 week and 1 month follow-ups)|||units on a scale||Standard Deviation|Mean
659174|NCT01885871|Secondary|Percent of Participants With Improvement Score >/=1|Improvement (clearing) in solar lentigines as assessed by participant using a 4-point VAS 0-3 scale where 0=no change and 3=very much improved. Scores >/=1 indicate improvement.|12 weeks post- final treatment|||percent of participants|||Number
659138|NCT01886690|Secondary|Change From Baseline in the Schirmer Test in the Worse Eye|The Schirmer's Test measures the rate of the secretion of tears produced by the eye over 5 minutes in the worse eye. The results indicate the presence of dry eye (Normal = greater than or equal to 10 millimeters (mm) of tears, Dry Eye = less than 10 mm of tears). The smaller the number, the more severe the dry eye. A positive number change from baseline indicates an increase in tears (improvement) and a negative number change from baseline indicates a decrease in tears (worsening).|Baseline, Day 90|Intent-to-Treat: all randomized patients who had data at the noted time point||Millimeters in 5 minutes (mm/5 min)||Standard Deviation|Mean
659139|NCT01886690|Secondary|Change From Baseline in Tear Break-up Time (TBUT) in the Worse Eye|TBUT is the time required for dry spots to appear on the surface of the eye after blinking in the worse eye. The longer it takes, the more stable the tear film. A short TBUT is a sign of poor tear film. A positive number change from baseline indicates an increase in TBUT (improvement) and a negative number change from baseline indicates a decrease in TBUT (worsening).|Baseline, Day 90|Intent-to-Treat: all randomized patients who had data at the noted time point||Seconds||Standard Deviation|Mean
659140|NCT01886690|Secondary|Change From Baseline in Corneal Staining in the Worse Eye|The cornea is the transparent front part of the eye which covers the iris and pupil. Corneal staining in the worse eye following administration of fluorescein dye in the eye is graded using a 6-point scale (0=no staining, 5=severe staining) over 5 areas of the clear central part of the eye for a minimum score of 0 and maximum score of 25. The higher the grade score, the worse the dry eye condition. A negative change from baseline represents a decrease in corneal staining (improvement) and a positive change from baseline represents an increase in corneal staining (worsening).|Baseline, Day 90|Per Protocol: all randomized patients who had no significant protocol violations and who had data at the noted time point||Scores on a Scale||Standard Deviation|Mean
659141|NCT01886690|Primary|Ocular Surface Disease Index© (OSDI) Score Using a 5-Point Scale|The OSDI© is a 12-question survey for patients to document their dry eye disease symptoms. Each question is rated on a 5-point scale (0=none of the time and 4 = all of the time). The scores are totaled over the 12 questions and normalized/converted to a score of 0-100 (0=no disability and 100=complete disability).|Day 90|Per Protocol: all randomized patients who had no significant protocol violations||Scores on a Scale||Standard Deviation|Mean
659142|NCT01886313|Primary|Average Daily Pain Score|The change in the Average Daily Pain Score (11-point Numeric Rating Scale (NRS)) from the Baseline Period to the Average Daily Pain Score of the last week of the Treatment Period. The minimum score is 0 and the maximum score is 10. A score of 0 indicates no pain while a score of 10 indicates worst possible pain.|6 weeks|1 patient withdrew early from study||units on a scale||Standard Deviation|Mean
659143|NCT01886300|Secondary|Number of Participants With Incidence of Adverse Events|An AE is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product|Up to 24 months|Participants present at the time of assessment were used for analysis.||Number of participants|||Number
659144|NCT01886300|Secondary|Incidence of Normalization of Serum Alanine Transaminase|Normalization of alanine transaminase (ALT) values means that ALT values out of the normal range returned to within the normal range.|Up to 24 months|As the sample size requirement for the study was not met, the study was terminated; no data for any of the participants was collected.|||||
659145|NCT01886300|Secondary|Percentage of Participants Who Become Hepatitis B Envelope Antigen Negative During the Observation Period|HBeAg is a protein from the hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people. HBeAg-negative hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus.|Up to 24 months|As the sample size requirement for the study was not met, the study was terminated; no data for any of the participants was collected.|||||
659146|NCT01886300|Secondary|Percentage of Participants With Hepatitis B Envelope Antigen Seroconversion and Hepatitis B Virus Deoxyribonucleic Acid Suppression (<2,000 IU/mL) During the Observation Period|HBeAg seroconversion is defined as the absence of HBeAg and the presence of antibody to hepatitis B antigen (anti-HBe) . A participant was considered to have achieved suppression of HBV DNA to <2,000 IU/mL if the HBV DNA measurement is lower than 2,000 IU/mL.|Up to 24 months|As the sample size requirement for the study was not met, the study was terminated; no data for any of the participants was collected.|||||
659147|NCT01886300|Secondary|Percentage of Participants With Loss of Hepatitis B Envelope Antigen During the Observation Period|Loss of HBeAg is defined as the absence of HBeAg. A participant was considered to have achieved HBeAg loss if the HBeAg measurement was reported as (a) ‘NEGATIVE’ or (b) a quantitative result was lower than the reported lower detection limit.|Up to 24 months|As the sample size requirement for the study was not met, the study was terminated; no data for any of the participants was collected.|||||
659148|NCT01886300|Secondary|Percentage of Participants With Suppression of Hepatitis B Virus Deoxyribonucleic Acid To <2,000 IU/mL During the Observation Period|A participant was considered to have achieved suppression of HBV DNA to <2,000 IU/mL if the HBV DNA measurement is lower than 2,000 IU/mL.|Up to 24 months|As the sample size requirement for the study was not met, the study was terminated; no data for any of the participants was collected.|||||
659149|NCT01886300|Primary|Percentage of Participants Who Become Hepatitis B Envelope Antigen-Negative and Anti-HBe-Positive During Treatment and at 6 and 12 Months After End of Treatment|HBeAg is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people. HBeAg-negative hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus.|12 months|As the sample size requirement for the study was not met, the study was terminated; no data for any of the participants was collected.|||||
659150|NCT01886300|Primary|Percentage of Participants With Suppression of Hepatitis B Virus Deoxyribonucleic Acid To <2,000 IU/mL at 6 Months After End of Treatment|A participant was considered to have achieved suppression of Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) to <2,000 International Units Per Milliliter (IU/mL) if the HBV DNA measurement is lower than 2,000 IU/mL.|6 months|As the sample size requirement for the study was not met, the study was terminated; no data for any of the participants was collected.|||||
659151|NCT01886287|Secondary|Rate of Progression Free Survival (PFS) at 6 Months|Progression-free survival, defined as rate of patients alive and free of progression from the date of first study treatment to the end of trial at 6 months. Progressive disease (PD): at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.|At 6 months|Evaluable participants on study at 6 months|||||
659152|NCT01886287|Primary|Number of Participants With Improved Frequency of Diarrhea|The frequencies of flushing, diarrhea, and carcinoid syndrome control rating (scale 1-5) will be measured and compared at week 0 and week 12 . These measurements will be compared using two-sided non-parametric paired Wilcoxon signed-rank.|At 12 weeks|Participants on study at 12 weeks||participants|||Number
659153|NCT01886235|Secondary|Tumor Vasculature|Sample tumor characteristics obtained from the intervention will be characterized using descriptive statistics (mean, medians) and 95% confidence intervals.|Up to 2 months|Stringent dosing requirements precluded assessment of tumor vasculature endpoints. These measurements will be addressed in future studies.|||||
659154|NCT01886235|Secondary|Percentage of Participants With Treatment Response|Treatment response was based upon the presence of a recurrence of the melanoma at either primary or metastatic sites.|Up to 5 years|All treated and eligible patients||percentage of participants||95% Confidence Interval|Number
659155|NCT01886235|Secondary|Median Progression Free Survival|Assessed using Kaplan Meier and Proportional Hazards methods. Collected through routine follow-up processes.|Up to 5 years|All treated and eligible patients||months||95% Confidence Interval|Median
659156|NCT01886235|Secondary|Median Overall Survival|Assessed using Kaplan Meier and Proportional Hazards methods. Collected through routine follow-up processes.|Up to 5 years|All treated and eligible patients||months||95% Confidence Interval|Median
659157|NCT01886235|Secondary|Complication Rate|Number of participants with an event that would disrupt the standard surgical procedure or create an adverse event that would not be anticipated from the standard surgery.|Up to 5 years|All treated and eligible patients||Participants|||Count of Participants
659158|NCT01886235|Secondary|Blood Flow Rates|Sample tumor characteristics obtained from the intervention will be characterized using descriptive statistics (mean, medians) and 95% confidence intervals.|Up to 2 months|All treated and evaluable patients. Only 7 patients had data available, one patient had an unobservable tumor and two patients the fluorscein never made it to the tumor.||micrometers per second||95% Confidence Interval|Mean
659159|NCT01886235|Secondary|"Percentage of Participants With Any Adverse Event"|Percentage of participants with any adverse event. Described using upper one-sided 95% Clopper Pearson confidence limits.|Up to 5 years|All treated and eligible patients.||percentage of participants||95% Confidence Interval|Number
659160|NCT01886235|Primary|Percentage of Participants With Successful Intravital Microscopy on Accessible Human Melanoma Tumors During Standard Local Excision|A successful intravital microscopic observation will include the ability to identify tumor vessels, measure tumor vessel diameters, determine vessel density per 10 x field and visualize fluorescein within the tumor vessels.|Up to 2 months|All treated and eligible patients||percentage of participants||95% Confidence Interval|Number
659161|NCT01885910|Secondary|Burning|the burning severity scale ranges from 0 to 10 with 0 being no burning and 10 being most extreme burning|every 4 weeks|participants with data||units on a scale||Standard Deviation|Mean
659162|NCT01885910|Secondary|Pruritis|the pruritis severity scale ranges from 0 to 5 with 0 being no pruritis and 5 being the most extreme pruritis|every 4 weeks|participants with data||units on a scale||Standard Deviation|Mean
659163|NCT01885910|Secondary|Oiliness|the oiliness severity scale ranges from 0 to 10 with 0 being no oiliness and 10 being most extreme oiliness|every 4 weeks|participants with data||units on a scale||Standard Deviation|Mean
659164|NCT01885910|Secondary|Peeling|the peeling severity scale ranges from 0 to 4 with 0 being no peeling and 4 being most extreme peeling|every four weeks|participants with data||units on a scale||Standard Deviation|Mean
659165|NCT01885910|Secondary|Dryness|the dryness severity scale ranges from 0 to 4 with 0 being no dryness and 4 being most extreme dryness|every 4 weeks|participants with data||units on a scale||Standard Deviation|Mean
659166|NCT01885910|Secondary|Erythema|the erythema severity scale ranges from 0 to 4 with 0 being no erythema and 4 being most extreme erythema|every 4 weeks|participants with data||units on a scale||Standard Deviation|Mean
659167|NCT01885910|Secondary|Nodule Counts|number of nodules counted|every four weeks|participants with data||nodules||Standard Deviation|Mean
659168|NCT01885910|Secondary|Percentage of Participants Who Are Responders at Week 16 and 20|Responders is the percentage of participants who have an IGA <3 at Week 16 and 20|Assessed every 4 weeks, reported at weeks 16 and 20|||percentage of participants|||Number
659169|NCT01885910|Secondary|Inflammatory and Non-inflammatory Lesion Counts||Every 4 weeks|participants with data||lesions||Standard Deviation|Mean
659170|NCT01885910|Primary|Percentage of Participants Who Remained Responders at Week 24|At week 12 responder had an IGA <3 on a 6-point scale ranging from 0 (clear) to 5 (very severe) and at Week 24 this response was maintained|Assessed every 4 weeks, reported at Week 24|only participants who were not lost to follow-up or did not withdraw consent were included in the final analysis||percentage of particpants|||Number
659171|NCT01885871|Secondary|Percent of Subjects With Post-treatment Adverse Event||During study duration 0-6 months.|||percent of participants|||Number
659172|NCT01885871|Secondary|Mean Pain Score Associated With Laser Treatment|Subjects graded the level of pain associated with laser treatment using a 0-10 scale where 0=no pain and 10=worse possible pain.|During treatment|||units on a scale||Full Range|Mean
659173|NCT01885871|Secondary|Percent of Participants Satisfied With Improvement (Clearing) in Solar Lentigines|Level of Satisfaction with Improvement (clearing) in solar lentigines as assessed by participants.|12 weeks post- final treatment|Based on subject questionnaires, 90% of subjects reported improvement (clearing) in benign pigmented lesions at 12 weeks post- final treatment. Scores >/=1 indicate improvement.||percent of participants|||Number
659177|NCT01885559|Secondary|Quality of Life Mental Component Summary|Short Form-36 Quality of Life Mental Component Summary ranges from 0 (worst possible outcome) to 100 (best possible outcome). Data from multiple years were analyzed with the primary focus on the change over time for the measure (from the slope for time from the model). The measure presented is the average annual change across the 8 years.|up to 8 years (annually assessed)|Intention to treat analysis||units on a scale per year||95% Confidence Interval|Mean
659178|NCT01885559|Secondary|Quality of Life Physical Component Summary|Short Form-36 Quality of Life Physical Component Summary ranges from 0 (worst possible outcome) to 100 (best possible outcome). Data from multiple years were analyzed with the primary focus on the change over time for the measure (from the slope for time from the model). The measure presented is the average annual change across the 8 years.|up to 8 years (annually assessed)|Intention to Treat analysis||units on a scale per year||95% Confidence Interval|Mean
659179|NCT01885559|Secondary|Cardiovascular Hospitalizations|Cause-specific hospitalizations (cardiovascular)|up to 8 years|Intention to Treat analysis||events|||Number
659180|NCT01885559|Secondary|Hospitalizations|Hospitalization for any cause|up to 8 years|Intention to treat analysis||events|||Number
659181|NCT01885559|Secondary|Aldosterone|Annual percent change in urinary aldosterone, centrally processed measure. Data from multiple years were analyzed with the primary focus on the change over time for the measure (from the slope for time from the model). The measure presented is the average annual percent change across the 8 years.|up at 8 years (annually assessed)|Intention to treat analyses||annual percent change||95% Confidence Interval|Mean
659182|NCT01885559|Secondary|Albuminuria|Annual percent change in 24 hour urine albumin, centrally processed. Data from multiple years were analyzed with the primary focus on the change over time for the measure (from the slope of the model). The measure presented is the average annual percent change across the 8 years.|up to 8 years (annually assessed)|Intention to treat analysis||annual percent change||95% Confidence Interval|Mean
659183|NCT01885559|Primary|Number of Participants With 50% Reduction of Baseline eGFR, End Stage Renal Disease (ESRD, Initiation of Dialysis or Preemptive Transplant), or Death.||Patients followed for 5-8 years with average of 6.5 years follow up|Intention to Treat analysis was used for the primary outcome||participants|||Number
659184|NCT01885117|Primary|Number of Subjects Reporting Unsolicited Adverse Events After Receiving One Dose of TIVf|The number of subjects in both age groups reporting any unsolicited AEs (between Day 1 to 4), serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal (throughout the study period), after receiving one dose of TIVf is reported.|Day 1(baseline) through Day 22 postvaccination|Analysis was done on the safety set population||Subjects|||Number
659185|NCT01885117|Primary|Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of TIVf|The number of adult and elderly subjects reporting solicited local and systemic AEs and other solicited AEs after receiving one dose of TIVf are reported.|Day 1 through Day 4 postvaccination|Analysis was done on the safety set population i.e all subjects who have post-vaccination AE or reactogenicity records||Subjects|||Number
659186|NCT01885117|Primary|Geometric Mean Ratio of Post Vaccination Versus Pre Vaccination HI Antibody Titers, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf|"The antibody responses following one dose of TIVf were evaluated in terms of GMRs of post vaccination against pre vaccination geometric mean HI titers against each of the three vaccine strains, three weeks after receiving one dose of TIVf.
The related European (CHMP) criterion for the assessment of immunogenicity is met if the GMR day 22/day 1 is >2.5 for adults aged 18 to ≤60 years and > 2.0 for subjects aged ≥61 years."|Day 22/ Day 1|Analysis was done on the per-protocol population||Ratio||95% Confidence Interval|Geometric Mean
659187|NCT01885117|Primary|Percentages of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After Receiving One Dose of TIVf|"Immunogenicity was assessed in terms of percentages of subjects in both age groups achieving seroconversion or significant increase in HI antibody titers after receiving one dose of TIVf.
Seroconversion is defined as percentage of subjects with a pre vaccination HI titer <10 to a post vaccination titer ≥40. Significant increase is defined as percentage of subjects with a pre vaccination HI titer ≥10 to at least a 4-fold increase in post vaccination HI antibody titers.
The related European (CHMP) criterion for the assessment of immunogenicity is met if>40 % for adults aged 18 to ≤60 years and>30% for subjects aged ≥61 years achieve seroconversion or significant increase in post vaccination HI titers."|Day 22 (postvaccination)/ Day 1 (baseline)|Analysis was done on the per-protocol population||percentages of subjects||95% Confidence Interval|Number
659188|NCT01885117|Primary|Percentages of Subjects With Haemagglutination Inhibition (HI) Titers ≥40, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf|"Immunogenicity was assessed in terms of percentages of subjects in both age groups with HI titers ≥40, against each of the three vaccine strains, three weeks after receiving one dose of TIVf.
The related European (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving HI titers ≥ 40 is >70% for adults aged 18 to ≤60 years and >60% for subjects aged ≥61 years."|Day 1 (baseline) and Day 22 (postvaccination)|Analysis was done on the per-protocol population||Percentages of subjects||95% Confidence Interval|Number
659189|NCT01885117|Primary|Geometric Mean Ratio (GMR) of Post Vaccination Versus Pre Vaccination Geometric Mean Areas (GMAs), After One Dose of TIVf|"The antibody responses were evaluated in terms of GMRs of post vaccination GMAs to pre vaccination GMAs against each of the three vaccine strains, three weeks after receiving one dose of TIVf.
The related European Committee for Human Medicinal Products (CHMP) criterion for the assessment of immunogenicity is met if the GMR day 22/day 1 is >2.5 for adults aged 18 to ≤60 years and > 2.0 for subjects aged ≥61 years."|Day 22 (postvaccination)/ Day 1 (baseline)|Analysis was done on the per-protocol population||Ratio||95% Confidence Interval|Geometric Mean
661776|NCT01833988|Secondary|Difference Between Closed-loop and Open-loop in Fraction of Time at Night Spent Within Glucose Ranges (< 70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, > 180 mg/dl, > 250 mg/dl)||1 week|||percentage of time||Standard Deviation|Mean
659190|NCT01885117|Primary|Percentages of Subjects With Seroconversion or Significant Increase in SRH Area, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf|"Immunogenicity was assessed in terms of percentages of subjects in both age groups achieving seroconversion or significant increase by SRH area against each of the three vaccine strains ,three weeks after receiving one dose of TIVf.
Seroconversion is defined as percentage of subjects with a pre vaccination SRH area ≤4mm2 achieving a post vaccination SRH area ≥25 mm2. Significant increase is defined as percentage of subjects with a pre vaccination SRH area >4mm2 achieving at least 50% increase in post vaccination SRH area.
The related European (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving post vaccination SRH areas ≥ 25mm2 is >40% for adults aged 18 to ≤60 years and >30% for subjects aged ≥61 years."|Day 22 (postvaccination) /Day 1 (Baseline)|Analysis was done on the per-protocol population||Percentages of subjects||95% Confidence Interval|Number
659191|NCT01885117|Primary|Percentage of Subjects With Single Radial Hemolysis (SRH) Areas ≥25mm2, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf|"Immunogenicity was assessed in terms of percentages of subjects in both age groups with SRH areas ≥25mm2 against each of the three vaccine strains, three weeks after receiving one dose of TIVf.
The related European (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving post vaccination SRH areas ≥ 25mm2 is >70% for adults aged 18 to ≤60 years and >60% for subjects aged ≥61 years."|Day 1 (baseline) and Day 22 (postvaccination)|Analysis was done on the per-protocol population i.e all subjects who have received study vaccination and provided immunogenicity data both at baseline and after vaccination; did not withdraw informed consent and did not have Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) confirmed influenza during the study.||Percentages of subjects||95% Confidence Interval|Number
659192|NCT01885104|Primary|Number of Participants With Inflammation of the Esophageal Mucosa|Participants underwent endoscopic examination of the esophageal mucosa at Visit 2 and Visit 3. Measurements were based on 0-3 Likert Scale Scores: 0 = No inflammation (no erythema, no erosion/ulceration); 1 = Mild inflammation (erythema without erosion/ulceration); 2 = Moderate inflammation (erythema with erosion); 3 = Severe inflammation (erythema with ulceration).|Visit 2 (Day 1) and Visit 3 (Day 17 ± 2 days), up to 19 days after start of treatment|Safety Population, which consisted of all participants who received at least 1 dose of PEG 3350 or placebo and had at least 1 postdose safety assessment.||Participants|||Number
659193|NCT01885104|Primary|Number of Participants With Inflammation of the Oral Mucosa|Participants underwent visual examination of the oral muscosa at Visit 2 and Visit 3. Measurements were based on 0-3 Likert Scale Scores: 0 = No inflammation (no erythema, no erosion/ulceration); 1 = Mild inflammation (erythema without erosion/ulceration); 2 = Moderate inflammation (erythema with erosion); 3 = Severe inflammation (erythema with ulceration).|Visit 2 (Day 1) and Visit 3 (Day 17 ± 2 days), up to 19 days after start of treatment|Safety Population, which consisted of all participants who received at least 1 dose of PEG 3350 or placebo and had at least 1 postdose safety assessment.||Particpants|||Number
659194|NCT01885000|Secondary|Percentage of Subject Reporting a Treatment-related Adverse Event||From consent signature, up to Day 8|APT (All Patient Treated) population||percentage of participants|||Number
659195|NCT01885000|Secondary|Percentage of Participants With at Least One Grade Improvement in the Clinician's Erythema Assessment (CEA)|Percentage of participants with at least one grade improvement in the CEA|Day 1, 3 hour after drug application|Participantes with a CEA score at this timepoint||percentage of participants|||Number
659196|NCT01885000|Secondary|Facial Appearance Since Starting the Treatment|"Percentage of subjects who answered A lot better/A little better to the question what do you think about your facial appearance since starting the treatment?"|Day 8|Subjects who answered the questionnaire at Day 8||percentage of participants|||Number
659197|NCT01885000|Primary|Satisfaction With the Overall Study Treatment|Percentage of participants who are very satisfied/satisfied/somewhat satisfied with the study treatment|Day 8|Subject who have answered the questionnaire at Day 8||percentage of participants|||Number
659198|NCT01884688|Primary|Increase in ENK (Expanded Natural Killer Cells) Cells 7 Days After Treatment|Number of participants with at least 4 fold increase in absolute CD3-CD56+ NK cell count/uL blood 7 days after infusion over the pre-study baseline level|7 days|||Participants|||Count of Participants
659199|NCT01884675|Secondary|Number of Participants With Testicular Function (Males Only) of Potential Clinical Concern Any Time Post Baseline|For male participants testicular function (total testosterone, sex hormone binding globulin [SHBG-calculated free testosterone), follicle stimulating hormone (FSH), luteinizing hormone (LH), and inhibin B were assessed at Weeks 4 and 16/early withdrawal. The testicular function data were collected, but after the study was terminated, not all endpoints listed in the protocol were analyzed, including Testicular Function. This decision was documented in the reporting and analysis plan prior to database lock.|Baseline, Weeks 4 and 16/early withdrawal|ITT Population|||||
659200|NCT01884675|Secondary|Number of Participants With Hematology Parameters of Potential Clinical Concern Any Time Post Baseline|Hematology parameters including hemoglobin, international normalized ratio (INR), and platelet count assessed any time post Baseline. Baseline is the last value recorded on or prior to start of study treatment. For hemoglobin: lower concern value and high concern value was considered as <100 gram per liter (G/L) and none respectively. For INR: lower concern value and high concern value was considered as none or >5 prothrombin time respectively. For platelet count: lower concern value and high concern value was considered as <50 giga cells per liter (GI/L) and >500 GI/L respectively. Participants with both normal and low values were counted once under their worst case (Low). Participants with both normal and high values were counted once under their worst case (High). Participants with both high and low values are counted under both categories.|Baseline (Week 0), Weeks 4, 8, 12 and 16/early withdrawal|Intent-to-Treat (ITT) Population: comprised of all randomized participants who received at least 1 dose of study drug. Only those participants with available data at Baseline and the specified timepoint (represented as n=X, X for placebo and ambrisentan respectively) were summarized.||Participants|||Number
659201|NCT01884675|Secondary|Number of Participants With Clinical Chemistry Parameters of Potential Clinical Concern Any Time Post Baseline|Clinical chemistry parameters including alanine amino transferase (ALT), aspartate amino transferase (AST), creatinine, gamma glutamyl transferase (GGT) and total bilirubin (TB) assessed any time post Baseline. ALT: lower concern value and high concern value was considered as none and >=3xupper limit of normal (ULN) respectively. AST: lower concern value and high concern value was considered as none or >=3xULN respectively. creatinine: lower concern value and high concern value was considered as none and >=176.8 micromoles per liter (umol/L) respectively. GGT: lower concern value and high concern value was considered as none and >=3xULN respectively. For TB: lower concern value was none and high concern value was >=2xULN. Participants with both normal and low values were counted once under their worst case (Low). Participants with both normal and high values were counted once under their worst case (High). Participants with both high and low values are counted under both categories.|Baseline (Week 0), Weeks 4, 8, 12 and 16/early withdrawal,|ITT Population||Participants|||Number
659202|NCT01884675|Secondary|Change From Baseline in Heart Rate Assessed at Weeks 4, 8, 12, and 16/Early Withdrawal|Vital sign measurements including heart rate at Weeks 4, 8, 12, and 16/Early Withdrawal weeks. Baseline is the last value recorded on or prior to start of study treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Week 0); Weeks 4, 8, 12, and 16/Early Withdrawal|Intent-to-Treat (ITT) Population: comprised of all randomized participants who received at least 1 dose of study drug. Only those participants with available data at Baseline and the specified timepoint (represented as n=X, X for placebo and ambrisentan respectively) were summarized.||beats per minute||Inter-Quartile Range|Median
659203|NCT01884675|Secondary|Change From Baseline in Supine Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Assessed at Weeks 4, 8, 12, and 16/Early Withdrawal|Vital sign measurements including supine systolic and diastolic blood pressure at Weeks 4, 8, 12, and 16/Early Withdrawal weeks. Supine blood pressure measurement was taken in a supine position having rested in this position for at least 10 minutes before each reading. Baseline is the last value recorded on or prior to start of study treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Week 0); Weeks 4, 8, 12, and 16/Early Withdrawal|Intent-to-Treat (ITT) Population: comprised of all randomized participants who received at least 1 dose of study drug. Only those participants with available data at Baseline and the specified timepoint (represented as n=X, X for placebo and ambrisentan respectively) were summarized.||millimeter of mercury (mmHg)||Inter-Quartile Range|Median
659204|NCT01884675|Secondary|Number of Participants With Significant Liver Events at Weeks 4, 8, 12, and 16/Early Withdrawal|A significant liver chemistry result is defined as any result which met the stopping criteria defined in the study protocol. Liver events were assessed at Screening, Baseline, Weeks 4, 8, 12, and 16/Early Withdrawal. Number of participants who reported a significant liver chemistry result are presented.|Weeks 4, 8, 12, and 16/Early Withdrawal|ITT Population||Participants|||Number
659205|NCT01884675|Secondary|Change From Baseline in Haematocrit Levels at Weeks 4, 8, 12, and 16/Early Withdrawal|Haematocrit levels were assessed at Screening, Baseline, Weeks 4, 8, 12, and 16/Early Withdrawal. Baseline is the last value recorded on or prior to start of study treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Week 0); Weeks 4, 8, 12, and 16/Early Withdrawal|Intent-to-Treat (ITT) Population: comprised of all randomized participants who received at least 1 dose of study drug. Only those participants with available data at Baseline and the specified timepoint (represented as n=X, X for placebo and ambrisentan respectively) were summarized.||Proportion of 1||Inter-Quartile Range|Median
659206|NCT01884675|Secondary|Change From Baseline in Haemoglobin Levels at Weeks 4, 8, 12, and 16/Early Withdrawal|Haemoglobin levels were assessed at Screening, Baseline, Weeks 4, 8, 12, and 16/Early Withdrawal. Baseline is the last value recorded on or prior to start of study treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Week 0); Weeks 4, 8, 12, and 16/Early Withdrawal|Intent-to-Treat (ITT) Population: comprised of all randomized participants who received at least 1 dose of study drug. Only those participants with available data at Baseline and the specified timepoint (represented as n=X, X for placebo and ambrisentan respectively) were summarized.||Grams per liter||Inter-Quartile Range|Median
659207|NCT01884675|Secondary|Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect or important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition.|From the start of study treatment and until follow up (Week 16/Follow up)|ITT Population||Participants|||Number
659208|NCT01884675|Secondary|Change From Baseline in Quality of Life as Measured by Short Form 36 Health Survey (SF-36)|The SF-36 v2 is a self-administered, health-related quality of life (QoL) metric. It is a 36-item questionnaire designed to measure 8 domains of functional health status and well-being: physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health as well as 2 summary measures (Physical Health and Mental Health). Each domain is scored from 0 (poorer health) to 100 (better health). Change from Baseline was calculated as the post-Baseline score minus the Baseline score. The SF-36 data were collected, but after the study was terminated, not all endpoints listed in the protocol were analyzed, including the SF-36. This decision was documented in the reporting and analysis plan prior to database lock.|Baseline and up to Week 16/Early Withdrawal|ITT Population|||||
662324|NCT01824446|Primary|Volume of Distribution (Vz/F) of Radiolabelled SSP-004184|The distribution of a medication between plasma and the rest of the body.|Up to 288 hours post-dose|PAS||Liters||Standard Deviation|Mean
659209|NCT01884675|Secondary|Percent Change From Baseline in Plasma N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP)|The ratio to baseline [BL] in NT-proBNP was calculated as the ratio of the value at the specified time-point to the BL value and was expressed as a percent change from BL. For each treatment group, the mean change from BL at the specified time-point was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the value at the specified time-point to BL on the original scale. The GM was expressed as a percentage (100*[GM – 1]). Standard Deviation(SD) is the SD of the mean change from baseline values on the log scale.|Baseline (Week 0); Weeks 4, 8, 12 and 16/Early Withdrawal|Intent-to-Treat (ITT) Population: comprised of all randomized participants who received at least 1 dose of study drug. Only those participants with available data at Baseline and the specified timepoint (represented as n=X, X for placebo and ambrisentan respectively) were summarized.||Percent change||95% Confidence Interval|Geometric Mean
659210|NCT01884675|Secondary|Change From Baseline in Cardiac Index at Week 16|Cardiac index is measure of cardiopulmonary hemodynamics. Baseline is the last value recorded on or prior to start of study treatment. Change from Baseline was calculated as the value at specified visit minus the Baseline value.|Baseline (Week 0) and Week 16|Intent-to-Treat (ITT) Population: comprised of all randomized participants who received at least 1 dose of study drug. Only those participants with available data at Baseline and the specified timepoint were summarized.||Litre per minute per meter squared||Inter-Quartile Range|Median
659211|NCT01884675|Secondary|Change From Baseline in Mean Right Atrial Pressure (mRAP) and Mean Pulmonary Artery Pressure (mPAP) at Week 16|mPAP and mRAP are measures of cardiopulmonary hemodynamics. Baseline is the last value recorded on or prior to start of study treatment. Change from Baseline was calculated as the value at specified visit minus the Baseline value.|Baseline (Week 0) and Week 16|Intent-to-Treat (ITT) Population: comprised of all randomized participants who received at least 1 dose of study drug. Only those participants with available data at Baseline and the specified timepoint (represented as n=X, X for placebo and ambrisentan respectively) were summarized.||Millimeter of mercury (mmHg)||Inter-Quartile Range|Median
659212|NCT01884675|Secondary|Number of Participants With Clinical Worsening of Chronic Thromboembolic Pulmonary Hypertension (CTEPH)|Clinical worsening of CTEPH is defined by the time from randomization to the first occurrence of death, lung transplantation, hospitalization for CTEPH, atrial septostomy, addition of parenteral prostanoids, or study withdrawal due to two or more early escape criteria included: a decrease from Baseline of at least 20 percent in the distance walked during the six-minute walk test; an increase of one or more WHO functional class; worsening right ventricular failure (e.g., as indicated by increased jugular venous pressure; new/worsening hepatomegaly, ascites, or peripheral edema; worsening echocardiographic parameters such as tricuspid annulus plane systolic excursion (TAPSE) and Tissue Doppler Imaging of the tricuspid annulus); rapidly progressing cardiogenic, hepatic, or renal failure; refractory systolic hypotension (systolic blood pressure less than 85 millimeter of mercury [mmHg]).|From randomization to Week 16/Follow up visit (21 weeks)|ITT Population||Participants|||Number
659213|NCT01884675|Secondary|Change From Baseline in Borg CR10 Scale (BCR10S) Immediately Following Exercise at Weeks 4, 8, 12 and 16/Early Withdrawal|The BCR10S score was collected immediately following completion of the 6-minute walk test. Baseline data was calculated as the average of the two BCR10S values obtained following the two 6MWD tests used in determining the Baseline 6MWD. If only one measurement was available, that measurement has been used. BCR10S scores ranges from 0 to 10 (0=nothing at all, 10=extremely strong). If participant's perception or feeling was stronger than ”10”, i.e “extremely strong”, “Maximal” – a larger number could be used, e.g. 12 or still higher i.e “Absolute maximum”). Change from Baseline was calculated as the value at specified visit minus the Baseline value.|Baseline (Week 0); Weeks 4, 8, 12 and 16/Early Withdrawal|Intent-to-Treat (ITT) Population: comprised of all randomized participants who received at least 1 dose of study drug. Only those participants with available data at Baseline and the specified timepoint (represented as n=X, X for placebo and ambrisentan respectively) were summarized.||Scores on a scale||Inter-Quartile Range|Median
659214|NCT01884675|Secondary|Change From Baseline in WHO Functional Class (FC) at Weeks 4, 8, 12 and 16/Early Withdrawal|The WHO FC indicates the severity of PAH and is an adaptation of the New York Heart Association classification. It was assessed by the investigator. There are four grades for WHO FC based on severity of symptoms (Class I = none, Class IV = most severe). This functional classification system links symptoms with activity limitations, and allows clinicians to quickly predict disease progression and prognosis, as well as the need for specific treatment regimens, irrespective of the underlying etiology of PAH. Baseline is the last value recorded on or prior to start of study treatment. Change from Baseline was calculated as the value at specified visit minus the Baseline value. For analyse purposes, the WHO FC Class categories of I-IV were mapped to a numeric scale of 1-4.|Baseline (Week 0); Weeks 4, 8, 12 and 16/Early Withdrawal|Intent-to-Treat (ITT) Population: comprised of all randomized participants who received at least 1 dose of study drug. Only those participants with available data at Baseline and the specified timepoint (represented as n=X, X for placebo and ambrisentan respectively) were summarized.||Scores on a scale||Inter-Quartile Range|Median
659215|NCT01884675|Secondary|Change From Baseline in Pulmonary Vascular Resistance (PVR) at Week 16|PVR is a measure of cardiopulmonary haemodynamics. Change from Baseline was calculated as value at specified visit minus Baseline value. Baseline is the last value recorded on or prior to start of study treatment.|Baseline (Week 0) and Week 16|ITT Population. Only those participants with available data at Baseline and the specified timepoint were analysed.||Dynes*second/centimeter^5||Inter-Quartile Range|Median
659216|NCT01884675|Primary|Change From Baseline in Six Minutes Walking Distance (6MWD) at Week 16|The 6-minute walk test was conducted according to the American Thoracic Society guidelines in accordance with local standard operating procedures. 6MWD was measured by a 6-minute walk test. This test measures the distance that a participant can walk in a period of 6 minutes. Change from baseline was calculated at Weeks 4, 8, 12 and 16. Change from Baseline was calculated as value at the specified visit minus the Baseline value. Data at Baseline is based on average of two consecutive test results during Screening/Baseline period that differ by <10%. If only one measurement was available, that measurement was used. In any cases where the protocol-defined criteria for Baseline 6MWD was not met, the Baseline value was based on the last two consecutive measurements for a participant.|Baseline (Week 0); Weeks 4, 8, 12 and 16/Early Withdrawal|Intent-to-Treat (ITT) Population: comprised of all randomized participants who received at least 1 dose of study drug. Only those participants with available data at Baseline and the specified timepoint (represented as n=X, X for placebo and ambrisentan respectively) were summarized.||Meters||Inter-Quartile Range|Median
659225|NCT01884571|Secondary|Collection of T-cell Subsets in Blood|Blood will be collected for ribonucleic acid (RNA).|Baseline Visit 2, Day 1, and Months 1, 2, 4, 6, 8 and 12, and at the Final Safety Visit if a subject discontinues study drug early||08/2017||||
659226|NCT01884571|Secondary|Change in Right Grip Strength|Right Hand grip will be measured using a study approved dynamometer to test the maximum isometric strength of the hand and forearm muscles.|Baseline Visits 1, 2, and 3, Day 1, Months 1, 2, 3, 4, 5, 6, 8 ,10 , and 12, and at the Final Safety Visit, if a subject discontinues study drug early.||08/2017||||
659227|NCT01884571|Secondary|Change in Left Grip Strength|Left hand grip will be measured using a study approved dynamometer to test the maximum isometric strength of the hand and forearm muscles.|Baseline Visits 1, 2, and 3, Day 1, Months 1, 2, 3, 4, 5, 6, 8 ,10 , and 12, and at the Final Safety Visit, if a subject discontinues study drug early.||08/2017||||
659228|NCT01884571|Secondary|Collection of Peripheral Blood Mononuclear Cells (PBMCs) in Blood|Blood will be drawn in order to characterize markers of the participants immune system and further the understanding of the immune factors that contribute to disease progression in ALS.|Baseline Visit 2, Day 1, Months 1, 2, 4, 6, 8 and 12, and at the Final Safety Visit if a subject discontinues study drug early.||08/2017||||
659229|NCT01884571|Secondary|Change in Cytokine Levels in Cerebrospinal Fluid (CSF)|Lumbar punctures (LPs) will be done to collect cerebrospinal fluid in order to characterize markers of the participants immune system and further the understanding of the immune factors that contribute to disease progression in ALS|Baseline Visit 2 and Months 2, 6 and 12.||08/2017||||
659230|NCT01884571|Secondary|Change in Hand-Held Dynamometry (HHD)|Hand held dynamometry (HHD) will be used as a quantitative measure of muscle strength for this study. Six proximal muscle groups will be examined bilaterally in both upper and lower extremities (shoulder flexion, elbow flexion, elbow extension, hip flexion, knee flexion, and knee extension), all of which have been validated against maximum voluntary isometric contraction (MVIC) testing. In addition, wrist extension, first dorsal interosseous contraction and ankle dorsiflexion will be measured bilaterally; these muscles are often affected in Amyotrophic Lateral Sclerosis.|Baseline Visits 1, 2, and 3, Day 1, Months 1, 2, 3, 4, 5, 6, 8 ,10 , and 12, and at the Final Safety Visit, if a subject discontinues study drug early.||08/2017||||
659231|NCT01884571|Secondary|Change in Slow Vital Capacity (SVC)|Vital capacity (VC), percent of predicted normal, will be determined using the slow VC method. SVC measures the amount of air exhaled following a deep breath. For this test, participants will hold a mouthpiece in their mouth, breathe in deeply, and breathe out as much air as they can. The test will be done seated in a chair and then repeated while e lying on an exam table at the Screening Visit. For all other visits, this test will be done with seated in a chair. This test will take 15-20 minutes. At the Screening visit, eligibility for Group A will be determined utilizing upright SVC.|Screening, Baseline Visits 1, 2, and 3, Day 1, Months 1, 2, 3, 4, 5, 6, 8 ,10 , and 12, and at the Final Safety Visit, if a subject discontinues study drug early.||08/2017||||
659232|NCT01884571|Primary|Number of Participants With an Average Increase in ALSFRS-R Score of One Point Per Month|The ALS Functional Rating Scale - Revised (ALSFRS-R) is an ordinal rating scale (0 through 4) used to determine the ALS patient's self assessment of their ability and need for assistance in 12 activities or functions. This is a validated scale, both in person and by phone, which provides a total score (best of 48) from four sub-scores which assess speech and swallowing, (bulbar function), use of upper extremities (cervical function), gait and turning in bed (lumbar function), and breathing (respiratory function). A clinical response will be defined as a rate of change of ALSFRS-R of +6 points over 6 months (mean of +1 point per month), where typically patients with ALS have a decline in ALSFRS-R by an average of -1/month.|Pre-Treatment Period (3 months prior to the start of treatment, 2 months prior to the start of treatment, and 1 month prior to the start of treatment), Treatment Period (Day 1 and then monthly until Month 6)|All study participants who received treatment are included in the analysis for this outcome measure, including participants who discontinued treatment early (available ALSFRS-R scores were used).||Participants|||Count of Participants
659233|NCT01884519|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|A serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|During the entire study period (Days 0-180)|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.||Subjects|||Number
659234|NCT01884519|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.|During the 21-day (Days 0-20) post-vaccination period|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.||Subjects|||Number
659235|NCT01884519|Secondary|Duration of Solicited General Symptoms.|Duration was defined as number of days with any grade of general symptoms.|During the 4-day (Days 0-3) post-vaccination period|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.||Days||Full Range|Median
659255|NCT01883986|Primary|Change From Baseline in Functional Assessment of Cancer Therapy-Lung Total Outcome Index Score at 3 Months|Patient Quality of Life including symptoms as measured by the FACT-L (Functional Assessment of Cancer Therapy-Lung Scale). The FACT-L outcome measure reported is the mean change in the TOI subscale (Total Outcome Index) of the instrument, computed as the differences between final and baseline visit scores. The TOI subscale range is 0-84 with a higher score indicating a better quality of life.|Baseline and 3 months|||units on a scale||Standard Deviation|Mean
659236|NCT01884519|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, increased sweating and fever [axillary temperature above 37.5 degrees Celsius (°C)]. Gastrointestinal symptoms included nausea, vomiting, diarrhea and/or abdominal pain. Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature above 39.0°C|During the 4-day (Days 0-3) post-vaccination period|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.||Subjects|||Number
659237|NCT01884519|Secondary|Duration of Solicited Local Symptoms.|Duration was defined as number of days with any grade of local symptoms.|During the 4-day (Days 0-3) post-vaccination period|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.||Days||Full Range|Median
659238|NCT01884519|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.|Solicited local symptoms assessed were ecchymosis, induration, pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal everyday activities. Grade 3 ecchymosis, induration, redness and swelling was greater than 100 millimeters (mm) i.e. >100mm.|During the 4-day (Days 0-3) post-vaccination period|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.||Subjects|||Number
659239|NCT01884519|Secondary|Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains.|MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata). This outcome measure was assessed by influenza vaccination status in subjects (18-60 years and >60 years) who had and who had not received an influenza vaccine during the 2 influenza seasons prior to season 2012/2013.|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Fold increase||95% Confidence Interval|Geometric Mean
659240|NCT01884519|Secondary|Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains.|A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata). This outcome measure was assessed by influenza vaccination status in subjects (18-60 years and >60 years) who had and who had not received an influenza vaccine during the 2 influenza seasons prior to season 2012/2013.|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
659241|NCT01884519|Secondary|Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the Three Vaccine Influenza Strains.|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata). This outcome measure was assessed by influenza vaccination status in subjects (18-60 years and >60 years) who had and who had not received an influenza vaccine during the 2 influenza seasons prior to season 2012/2013.|At Day 0 and Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
659242|NCT01884519|Secondary|Humoral Immune Response in Terms of HI Antibody Titers Against Each of the Three Vaccine Influenza Strains|Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata). This outcome measure was assessed by influenza vaccination status in subjects (18-60 years and >60 years) who had and who had not received an influenza vaccine during the 2 influenza seasons prior to season 2012/2013.|At Days 0 and 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Titers||95% Confidence Interval|Geometric Mean
659243|NCT01884519|Primary|Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the Three Vaccine Influenza Strains Above the Cut-off Value.|SPP was defined as the number of vaccinated subjects with a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:40. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
659244|NCT01884519|Primary|Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains.|MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Fold increase||95% Confidence Interval|Geometric Mean
659245|NCT01884519|Primary|Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains.|A seroconverted subjects was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
659246|NCT01884519|Primary|Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the Three Vaccine Influenza Strains.|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).|At Day 0 and Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
659247|NCT01884519|Primary|Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Influenza Strains|Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).|At Day 0 and Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Titer||95% Confidence Interval|Geometric Mean
659248|NCT01884064|Primary|Cortical Silent Period|Subjects performed an isometric abduction contraction of the index finger against a strain gauge coupled to a load cell. A single TMS pulse was applied 2-3 s after contraction initiation and subjects were instructed to relax 2-3 s after stimulation. The duration of the CSP was measured on a trial-by-trial basis and was delineated by the first superimposed TMS-evoked EMG spike (onset) and the return of activity to 50% of prestimulus EMG signal (offset). The mean CSP duration was calculated for each block of measurements. The duration of CSP is thought to be related to intracortical GABAergic synapse-mediated inhibition in the stimulated cortical region. Measures of CSP have been shown to be reliable in repeated measures studies to determine an effect of intervention within a group of subjects (Orth and Rothwell 2004; Borich et al., 2009). Values are calculated as the value recorded at the latest time minus the earliest time point.|Baseline and Day 5|||milliseconds||Standard Deviation|Mean
659249|NCT01883999|Secondary|Freedom From New Onset Buttock Claudication Arising From the Side of the Body Treated With the Iliac Branch Component (IBC) and Internal Iliac Component (IIC)|Freedom from new onset buttock claudication arising from the side of the body treated with the Iliac Branch Component (IBC) and Internal Iliac Component (IIC).|Through 6 month follow-up visit|Subjects having IBC and IIC components implanted and meeting inclusion/exclusion criteria||participants|||Number
659250|NCT01883999|Primary|Freedom From: Reintervention on Iliac Branch Component (IBC) or Internal Iliac Component (IIC) Due to Type I/III Endoleak or to Re-establish Patency Due to 60% Occlusion or Greater, or Complete Loss of Blood Flow in Leg of IBC or IIC|"Freedom from all of the following:
Reintervention on Iliac Branch Component (IBC) or Internal Iliac Component (IIC) due to Type I/III endoleak as determined by Clinical Events Committee (CEC).
Complete loss of blood flow in leg of IBC or IIC as assessed by Core Laboratory
Reintervention on IBC or IIC to re-establish patency due to 60% occlusion or greater as determined by CEC."|Through 6 month follow-up visit|Subjects having IBC and IIC components implanted and meeting inclusion/exclusion criteria||participants|||Number
659251|NCT01883999|Primary|Freedom From Composite of the Following: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Conversion to Open Surgical Repair|Freedom from composite of the following: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Conversion to open surgical repair.|30 days post-treatment|Subjects initiating IBE procedure and meeting inclusion/exclusion criteria||participants|||Number
659252|NCT01883986|Secondary|Change From Baseline in Clinician Knowledge of Patient Preferences at 3 Months|Clinician knowledge of patient preferences for life sustaining treatments will be assessed at baseline and at the study end point by asking 2 validated questions to both the clinician and the patient and determining the level of agreement between the responses.|Baseline and 3 months|No data was collected due to poor provider response to surveys.|||||
659253|NCT01883986|Secondary|Change in Baseline Quality of Clinician Communication at 3 Months|"The quality of clinician end-of-life communication will be measured from the patient's perspective by the Quality of Communication Questionnaire (QOC).The QOC consists of 13 items divided into two subscales, six general communication items and seven end-of-life topics. We analyzed the six-item general communication skills scale, which scores range from 0-10. The higher the score the better the provider's communication is. We asked patients to answer the questions in reference to the provider who was primarily responsible for managing their lung cancer."|Baseline and 3 months|||units on a scale||Standard Deviation|Mean
659254|NCT01883986|Secondary|Change From Baseline in Patient Satisfaction of Care at 3 Months|Patient satisfaction with care will be assessed by using the FAMCARE- Patient Survey 13 (full unabbreviated scale name). The FAMCARE is a 13 item, 5 point likert-scale validated questionnaire measuring patient satisfaction with cancer care and assessing interactions with health care providers, performance status and symptom burden. Only total scores are reported (no subscales). The total scores range from 13-65 with scores of 52 > indicating satisfaction with care. The higher the score the better the outcome (better satisfaction with care). In full randomized clinical trials, the estimated minimal important difference is 5 points from baseline to 12 weeks.|Baseline and 3 months|||units on a scale||Standard Deviation|Mean
659256|NCT01883908|Primary|Number of Patients Completing Acupuncture Treatment|Feasibility is defined as greater than 80% patients in the trial completing at least 4 acupuncture sessions.|16 weeks|Zero participants analyzed due to early termination of study.|||||
659258|NCT01883895|Secondary|Pain Threshold|Subjects will press a button attached to a timer out of view of the subject when the pressure stimulus first becomes painful. This will utilize a protocol recognized as a validated measurement of pain threshold.|We will monitor the subject's reported pain thresholds during the two minute interval that the pressure stimulus is applied. Expected average is less than one minute.|||seconds||95% Confidence Interval|Mean
659259|NCT01883895|Primary|Change in Pain Intensity Ratings (0-100 Pain Scale)|"Subjects will rate pain intensity using a 0 (no pain) to 100 (most intense pain imaginable) pain rating scale before and after application of a validated pressure stimulator immediately prior to, and after exercise.
Ratings will be recorded at 20 second intervals following each administration of the pressure stimulator for a total of 120 seconds. The ratings will then be averaged over all the time points."|Average pain rating over 120 seconds|Participants completing both exercise sessions and control session||scores on a scale||95% Confidence Interval|Mean
659260|NCT01883635|Other Pre-specified|Provision of Social Support|Change in provision of social support from baseline to 6 weeks as reported by the cancer survivor was measured by the Dyadic Support Questionnaire (DSQ). At each time point (baseline and 6 weeks), this questionnaire had a total score range of 0-45, with higher scores signifying more support. We subtracted the baseline score from the 6 week DSQ score; the change score reported below thus has a range from -45 to 45, with higher scores signifying more support.|Baseline to post-intervention (6 weeks later)|This Additional Outcome analysis looked only at cancer survivors assigned to the Individual Exercise Intervention (n=22) and the Dyadic Exercise Intervention (n=20).||units on a scale||Standard Deviation|Mean
659261|NCT01883635|Secondary|Immune Biomarkers|We measured improvement in immune biomarkers with IL-6, an inflammatory cytokine assessed in the serum of cancer survivors. Numbers presented below are change scores calculated by subtracting baseline IL-6 from post-intervention IL-6 (6 weeks later); lower numbers indicate less inflammation, hypothesized to be linked with better immune function.|Baseline to post-intervention (6 weeks later)|The Secondary Outcome analysis looked only at cancer survivors assigned to the Individual Exercise Intervention (n=22) and the Dyadic Exercise Intervention (n=20).||ng/mL||Standard Deviation|Mean
659262|NCT01883635|Primary|Psychological Distress|Change in psychological distress in the cancer survivor from baseline to 6 weeks, as measured by the Profile of Moods States (POMS) total score. At each time point (baseline and 6 weeks), this questionnaire had a total score range of 0-200, with lower scores signifying less distress. We subtracted the baseline POMS score from the 6 week POMS score; the change score reported below thus has a range from -200 to 200, with lower scores signifying less distress.|Baseline to post-intervention (6 weeks later)|The Primary Outcome analysis looked only at cancer survivors assigned to the Individual Exercise Intervention (n=22) and the Dyadic Exercise Intervention (n=20).||units on a scale||Standard Deviation|Mean
659263|NCT01883453|Primary|Reducing Symptoms of a Common Cold|"Using the Wisconsin Upper Respiratory Symptom Score (WURSS-21)it is possible to assess if a nasal spray containing glucose oxidase and glucose would be able to reduce symptoms of a common Cold.
WURSS 21 is a validated tool of calculating the degree of common Cold symptoms. It consists of 21 questions (20 questions are possible to evaluate) which are graded from 0 to 7 (worst degree of symptoms). These 20 questions (sum of all symptoms) are evaluated every day, Min value is thus 0 and max value/person/day is 140. It is thus possible to calculate the mean value of sum of symptoms for each day in the both groups."|One week|Only the participants that fullfilled the study and who had a positive virus sample (Influensa and adenoviruses excluded) were included in the results. These are the participants that are supposed to benefit from a nasal spray with GO.||units on a scale||Full Range|Mean
659264|NCT01883440|Primary|Sum of All Symptoms of All Persons That Fullfilled the Study|"Symptoms of a common cold, recorded in a home protocol, Wisconsin Upper Respiratory Symptom Score 21 (WURSS21) daily for 7 days was used as the evaluation method of the treatment. WURSS-21 is a validated protocol for assessing symptoms of a common cold. We used this protocol at start, before the persons in the study started their treatment and thereafter every day for the next 7 days. WURSS 21 consists of 21 questions (last question is not valid) regarding different symptoms as: running nose, sore throat, cough, blocked nose, etc. Every such question is graded from 0-7, 0 is defined as no such symptom and the number 7 means the worst possible symptom. The outcome measure is predominantly calculated as the sum of all symptoms in the WURSS-21 protocol, which means that the value from each of the 20 questions (min=0, max=140) is summarized every day for each of the participants, which gives a mean value for both groups every day."|7 days|All of the persons that fullfilled the study||units on a scale||Full Range|Mean
659265|NCT01883440|Primary|Sum of All Symptoms in Viruspositive Persons|"Symptoms of a common cold, recorded in a home protocol, Wisconsin Upper Respiratory Symptom Score 21 (WURSS21) daily for 7 days was used as the evaluation method of the treatment. WURSS-21 is a validated protocol for assessing symptoms of a common cold. We used this protocol at start, before the persons in the study started their treatment and thereafter every day for the next 7 days. WURSS 21 consists of 21 questions (last question is not valid) regarding different symptoms as: running nose, sore throat, cough, blocked nose, etc. Every such question is graded from 0-7, 0 is defined as no such symptom and the number 7 means the worst possible symptom. The outcome measure is predominantly calculated as the sum of all symptoms in the WURSS-21 protocol, which means that the value from each of the 20 questions (min=0, max=140) is summarized every day for each of the participants, which gives a mean value for both groups every day."|One week|The persons analyzed were those that had a positive viral sampling with Parainfluenza, Corona or Rhinoviruses, that is: the viruses that most often causes common cold and also would be accessible for treatment with a nasal spray.||units on a scale||Full Range|Mean
659266|NCT01883427|Primary|Respiratory Infectious Symptoms|Days with upper respiratory tract infection symptoms during a 3 months period are recorded in a home protocol by the parents of the children.|3 months of recording|Only a total of 40 Children fulfilled the study, which means that the Power are to low.||days||Standard Deviation|Mean
659267|NCT01882907|Other Pre-specified|To Compare Changes of Adipocytokine From Baseline Between Vildagliptin + Metformin and Pioglitazone + Metformin Groups||16 weeks, visit 5||||||
659268|NCT01882907|Other Pre-specified|To Compare Changes of Homeostasis Model Assessment-insulin Resistance and Beta From Baseline Between Vildagliptin + Metformin and Pioglitazone + Metformin Groups||16 weeks, visit 5||||||
659269|NCT01882907|Other Pre-specified|To Compare Changes of Insulin and C-peptide From Baseline Between Vildagliptin + Metformin and Pioglitazone + Metformin Groups||16 weeks, visit 5||||||
659270|NCT01882907|Secondary|To Compare Numbers of Participants With Adverse Events Between Vildagliptin + Metformin and Pioglitazone + Metformin Groups|"Safety assessments
- hypoglycemia, other side effects, Laboratory data, Physical examination, Vital sign with blood pressure and pulse rate, Electrocardiography"|16 weeks, visit 3,4,5||||||
659271|NCT01882907|Secondary|To Compare Changes of Body Weight From Baseline Between Vildagliptin + Metformin and Pioglitazone + Metformin Groups||16 weeks, visit 5||||||
659272|NCT01882907|Secondary|To Compare Changes of Lipid Profiles From Baseline Between Vildagliptin + Metformin and Pioglitazone + Metformin Groups||16 weeks, visit 5||||||
659273|NCT01882907|Secondary|To Compare Changes of FPG and PPG From Baseline Between Vildagliptin + Metformin and Pioglitazone + Metformin Groups||16 weeks , visit 5||||||
659274|NCT01882907|Primary|Non-inferiority of HbA1C Change From Baseline in Vildagliptin + Metformin Group Compared With Pioglitazone + Metformin Group||16 weeks|||% (change of HbA1c)||Standard Deviation|Mean
659275|NCT01882868|Secondary|Volume of Distribution at the Steady State (Vss) for Irinotecan: Participants With Additional Blood Sampling for Detailed PK Analysis|In 10 participants of ITT population, additional blood samples were obtained for detailed non-compartmental PK analysis of irinotecan in combination with aflibercept and 5-FU in Cycle 1.|Predose (prior to aflibercept infusion), 1.5, 2, 4.5 and 23 hours post irinotecan infusion on Day 1 of Cycle 1|Subset of ITT population with additional blood sampling for detailed non-compartmental PK analysis. Number of participants analyzed=participants with PK assessment for the subset analysis.||liter||Standard Deviation|Mean
659276|NCT01882868|Secondary|Total Body Clearance (CL) for Irinotecan: Participants With Additional Blood Sampling for Detailed PK Analysis|In 10 participants of ITT population, additional blood samples were obtained for detailed non-compartmental PK analysis of irinotecan in combination with aflibercept and 5-FU in Cycle 1.|Pre-dose (prior to aflibercept infusion), 1.5, 2, 4.5 and 23 hours post irinotecan infusion on Day 1 of Cycle 1|Subset of ITT population with additional blood sampling for detailed non-compartmental PK analysis. Number of participants analyzed=participants with PK assessment for the subset analysis.||liter/hour||Standard Deviation|Mean
659277|NCT01882868|Secondary|Active Metabolite SN-38 / Irinotecan Ratio on Area Under the Concentration Time Curve (Rmet): Participants With Additional Blood Sampling for Detailed PK Analysis|In 10 participants of ITT population, additional blood samples were obtained for detailed non - compartmental PK analysis of irinotecan and SN-38 in combination with aflibercept and 5-FU in Cycle 1.|Pre-dose (prior to aflibercept infusion), 1.5, 2, 4.5 and 23 hours post irinotecan infusion on Day 1 of Cycle 1|Subset of ITT population with additional blood sampling for detailed non-compartmental PK analysis. Number of participants analyzed=participants with PK assessment for the subset analysis. Here 'n' signifies number of participants with available data for specified category.||ratio||Standard Deviation|Mean
659278|NCT01882868|Secondary|Terminal Elimination Half-life (t1/2z) for Irinotecan and Its Active Metabolite SN-38: Participants With Additional Blood Sampling for Detailed PK Analysis|In 10 participants of ITT population, additional blood samples were obtained for detailed non-compartmental PK analysis of irinotecan and SN-38 in combination with aflibercept and 5-FU in Cycle 1.|Pre-dose (prior to aflibercept infusion), 1.5, 2, 4.5 and 23 hours post irinotecan infusion on Day 1 of Cycle 1|Subset of ITT population with additional blood sampling for detailed non-compartmental PK analysis. Number of participants analyzed=participants with PK assessment for the subset analysis. Here 'n' signifies number of participants with available data for specified category.||hours||Standard Deviation|Mean
659279|NCT01882868|Secondary|Area Under the Concentration Time Curve (AUC) for Irinotecan and Its Active Metabolite SN-38: Participants With Additional Blood Sampling for Detailed PK Analysis|In 10 participants of ITT population, additional blood samples were obtained for detailed non-compartmental PK analysis of irinotecan and SN-38 in combination with aflibercept and 5-FU in Cycle 1.|Pre-dose (prior to aflibercept infusion), 1.5, 2, 4.5 and 23 hours post irinotecan infusion on Day 1 of Cycle 1|Subset of ITT population with additional blood sampling for detailed non-compartmental PK analysis. Number of participants analyzed=participants with PK assessment for the subset analysis. Here 'n' signifies number of participants with available data for specified category.||ng*h/mL||Standard Deviation|Mean
659280|NCT01882868|Secondary|Area Under the Concentration Time Curve From Time 0 to the Time of Last Quantifiable Concentration (AUClast) for Irinotecan and Its Active Metabolite SN-38: Participants With Additional Blood Sampling for Detailed PK Analysis|In 10 participants of ITT population, additional blood samples were obtained for detailed non-compartmental PK analysis of irinotecan and SN-38 in combination with aflibercept and 5-FU in Cycle 1.|Pre-dose (prior to aflibercept infusion), 1.5, 2, 4.5 and 23 hours post irinotecan infusion on Day 1 of Cycle 1|Subset of ITT population with additional blood sampling for detailed non-compartmental PK analysis. Number of participants analyzed=participants with PK assessment for the subset analysis.||ng*h/mL||Standard Deviation|Mean
659281|NCT01882868|Secondary|Maximum Observed Plasma Concentration (Cmax) for Irinotecan and Its Active Metabolite SN-38: Participants With Additional Blood Sampling for Detailed PK Analysis|In 10 participants of ITT population, additional blood samples were obtained for detailed non-compartmental PK analysis of irinotecan and SN-38 in combination with aflibercept and 5-FU in Cycle 1.|Predose (prior to aflibercept infusion), 1.5, 2, 4.5 and 23 hours post irinotecan infusion on Day 1 of Cycle 1|Subset of ITT population with additional blood sampling for detailed non-compartmental PK analysis. Number of participants analyzed=participants with PK assessment for the subset analysis.||ng/mL||Standard Deviation|Mean
659282|NCT01882868|Secondary|Clearance at Steady State (CLss) for 5-FU: Participants With Additional Blood Sampling for Detailed PK Analysis|In 10 participants of ITT population, additional blood samples were obtained for detailed non-compartmental PK analysis of 5-FU in combination with aflibercept and irinotecan in Cycle 1.|Pre-dose (prior to aflibercept infusion), 2.5, 21 and 45 hours post 5-FU infusion on Day 1 of Cycle 1|Subset of ITT population with additional blood sampling for detailed non-compartmental PK analysis. Number of participants analyzed=participants with PK assessment for the subset analysis.||liter/hour||Standard Deviation|Mean
659283|NCT01882868|Secondary|Steady State Drug Concentration (Css) for 5-FU: Participants With Additional Blood Sampling for Detailed PK Analysis|In 10 participants of ITT population, additional blood samples were obtained for detailed non-compartmental PK analysis of 5-FU in combination with aflibercept and irinotecan in Cycle 1.|Pre-dose (prior to aflibercept infusion), 2.5, 21 and 45 hours post 5-FU infusion on Day 1 of Cycle 1|Subset of ITT population with additional blood sampling for detailed non-compartmental PK analysis. Number of participants analyzed=participants with PK assessment for the subset analysis.||ng/mL||Standard Deviation|Mean
659284|NCT01882868|Secondary|Terminal Elimination Half-life (t1/2z) for Free Aflibercept: Participants With Additional Blood Sampling for Detailed PK Analysis|In 10 participants of ITT population, additional blood samples were obtained for detailed non-compartmental PK analysis of free aflibercept in combination with irinotecan and 5-FU in Cycle 1.|Pre-dose (prior to aflibercept infusion), 1, 2, 4, 8, 24, 48, 168 and 336 hours post aflibercept infusion on Day 1 of Cycle 1|Subset of ITT population with additional blood sampling for detailed non-compartmental PK analysis. Number of participants analyzed=participants with PK assessment for the subset analysis.||days||Standard Deviation|Mean
659285|NCT01882868|Secondary|Volume of Distribution at the Steady State (Vss) for Free Aflibercept: Participants With Additional Blood Sampling for Detailed PK Analysis|In 10 participants of ITT population, additional blood samples were obtained for detailed non-compartmental PK analysis of free aflibercept in combination with irinotecan and 5-FU in Cycle 1.|Pre-dose (prior to aflibercept infusion), 1, 2, 4, 8, 24, 48, 168 and 336 hours post aflibercept infusion on Day 1 of Cycle 1|Subset of ITT population with additional blood sampling for detailed non-compartmental PK analysis. Number of participants analyzed=participants with PK assessment for the subset analysis.||liters||Standard Deviation|Mean
659286|NCT01882868|Secondary|Total Body Clearance (CL) for Free Aflibercept: Participants With Additional Blood Sampling for Detailed PK Analysis|In 10 participants of ITT population, additional blood samples were obtained for detailed non-compartmental PK analysis of free aflibercept in combination with irinotecan and 5-FU in Cycle 1.|Pre-dose (prior to aflibercept infusion), 1, 2, 4, 8, 24, 48, 168 and 336 hours post aflibercept infusion on Day 1 of Cycle 1|Subset of ITT population with additional blood sampling for detailed non-compartmental PK analysis. Number of participants analyzed=participants with PK assessment for the subset analysis.||liter/day||Standard Deviation|Mean
659287|NCT01882868|Secondary|Area Under the Concentration Time Curve (AUC) for Free Aflibercept: Participants With Additional Blood Sampling for Detailed PK Analysis|In 10 participants of ITT population, additional blood samples were obtained for detailed non-compartmental PK analysis of free aflibercept in combination with irinotecan and 5-FU in Cycle 1.|Pre-dose (prior to aflibercept infusion), 1, 2, 4, 8, 24, 48, 168 and 336 hours post aflibercept infusion on Day 1 of Cycle 1|Subset of ITT population with additional blood sampling for detailed non-compartmental PK analysis. Number of participants analyzed=participants with PK assessment for the subset analysis.||mcg*day/mL||Standard Deviation|Mean
659288|NCT01882868|Secondary|Area Under the Concentration Time Curve From Time 0 to 14 Days Post Start of Infusion (AUC0-14 Day) for Free and VEGF-Bound Aflibercept: Participants With Additional Blood Sampling for Detailed PK Analysis|In 10 participants of ITT population, additional blood samples were obtained for detailed non-compartmental PK analysis of free and VEGF-bound aflibercept in combination with irinotecan and 5-FU in Cycle 1.|Predose (prior to aflibercept infusion), 1, 2, 4, 8, 24, 48, 168 and 336 hours post aflibercept infusion on Day 1 of Cycle 1|Subset of ITT population with additional blood sampling for detailed non-compartmental PK analysis. Number of participants analyzed=participants with PK assessment for the subset analysis. Here 'n' signifies number of participants with available data for specified category.||mcg*day/mL||Standard Deviation|Mean
659289|NCT01882868|Secondary|Area Under the Concentration Time Curve From Time 0 to the Time of Last Quantifiable Concentration (AUClast) for Free and VEGF-Bound Aflibercept: Participants With Additional Blood Sampling for Detailed PK Analysis|In 10 participants of ITT population, additional blood samples were obtained for detailed non-compartmental PK analysis of free and VEGF-bound aflibercept in combination with irinotecan and 5-FU in Cycle 1.|Predose (prior to aflibercept infusion), 1, 2, 4, 8, 24, 48, 168 and 336 hours post aflibercept infusion on Day 1 of Cycle 1|Subset of ITT population with additional blood sampling for detailed non-compartmental PK analysis. Number of participants analyzed=participants with PK assessment for the subset analysis. Here 'n' signifies number of participants with available data for specified category.||mcg*day/mL||Standard Deviation|Mean
659290|NCT01882868|Secondary|Time to Reach Maximum Plasma Concentration Observed (Tmax) for Free and VEGF-Bound Aflibercept in Cycle 1: Participants With Additional Blood Sampling for Detailed PK Analysis|In 10 participants of ITT population, additional blood samples were obtained for detailed non-compartmental PK analysis of free and VEGF-bound aflibercept in combination with irinotecan and 5-FU in Cycle 1.|Predose (prior to aflibercept infusion), 1, 2, 4, 8, 24, 48, 168 and 336 hours post aflibercept infusion on Day 1 of Cycle 1|Subset of ITT population with additional blood sampling for detailed non-compartmental PK analysis. Number of participants analyzed=participants with PK assessment for the subset analysis. Here 'n' signifies number of participants with available data for specified category.||days||Full Range|Median
659291|NCT01882868|Secondary|Maximum Observed Plasma Concentration (Cmax) for Free and Vascular Endothelial Growth Factor (VEGF)-Bound Aflibercept: Participants With Additional Blood Sampling for Detailed PK Analysis|In 10 participants of ITT population, additional blood samples were obtained for detailed non-compartmental PK analysis of free and VEGF-bound aflibercept in combination with irinotecan and 5-FU in Cycle 1.|Predose (prior to aflibercept infusion), 1, 2, 4, 8, 24, 48, 168 and 336 hours post aflibercept infusion on Day 1 of Cycle 1|Subset of ITT population with additional blood sampling for detailed non-compartmental PK analysis. Number of participants analyzed=participants with PK assessment for the subset analysis. Here 'n' signifies number of participants with available data for specified category.||mcg/mL||Standard Deviation|Mean
659292|NCT01882868|Secondary|Volume of Distribution at the Steady State (Vss) for Free Aflibercept: ITT Population|Sparse blood sampling was performed on 52 participants and additional blood sampling for detailed PK analysis was performed on 10 participants as per protocol. A population PK analysis was performed and an overall data is reported for all the participants.|Pre-dose, 1, 4, 24, 336 hours post aflibercept infusion on Day 1 of Cycle 1 for participants with sparse sampling & pre-dose, 1, 2, 4, 8, 24, 48, 168, 336 hours post aflibercept infusion on Day 1 of Cycle 1 for participants with additional sampling|ITT population included all registered participants.||liters||Standard Deviation|Mean
659293|NCT01882868|Secondary|Total Body Clearance (CL) for Free Aflibercept: ITT Population|Sparse blood sampling was performed on 52 participants and additional blood sampling for detailed PK analysis was performed on 10 participants as per protocol. A population PK analysis was performed and an overall data is reported for all the participants.|Pre-dose, 1, 4, 24, 336 hours post aflibercept infusion on Day 1 of Cycle 1 for participants with sparse sampling & pre-dose, 1, 2, 4, 8, 24, 48, 168, 336 hours post aflibercept infusion on Day 1 of Cycle 1 for participants with additional sampling|ITT population included all registered participants.||liter/day||Standard Deviation|Mean
659294|NCT01882868|Secondary|Area Under the Concentration Time Curve (AUC) for Free Aflibercept: ITT Population|Sparse blood sampling was performed on 52 participants and additional blood sampling for detailed PK analysis was performed on 10 participants as per protocol. A population PK analysis was performed and an overall data is reported for all the participants.|Pre-dose, 1, 4, 24, 336 hours post aflibercept infusion on Day 1 of Cycle 1 for participants with sparse sampling & pre-dose, 1, 2, 4, 8, 24, 48, 168, 336 hours post aflibercept infusion on Day 1 of Cycle 1 for participants with additional sampling|ITT population included all registered participants.||mcg*day/mL||Standard Deviation|Mean
659295|NCT01882868|Secondary|Area Under the Concentration Time Curve From Time 0 to 14 Days Post Start of Infusion (AUC0-14 Day) for Free Aflibercept: ITT Population|Sparse blood sampling was performed on 52 participants and additional blood sampling for detailed PK analysis was performed on 10 participants as per protocol. A population PK analysis was performed and an overall data is reported for all the participants.|Pre-dose, 1, 4, 24, 336 hours post aflibercept infusion on Day 1 of Cycle 1 for participants with sparse sampling & pre-dose, 1, 2, 4, 8, 24, 48, 168, 336 hours post aflibercept infusion on Day 1 of Cycle 1 for participants with additional sampling|ITT population included all registered participants.||mcg*day/mL||Standard Deviation|Mean
659296|NCT01882868|Secondary|Maximum Observed Plasma Concentration (Cmax) for Free Aflibercept: ITT Population|Sparse blood sampling was performed on 52 participants and additional blood sampling for detailed pharmacokinetic (PK) analysis was performed on 10 participants as per protocol. A population PK analysis was performed and an overall data is reported for all the participants.|Pre-dose, 1, 4, 24, 336 hours post aflibercept infusion on Day 1 of Cycle 1 for participants with sparse sampling & pre-dose, 1, 2, 4, 8, 24, 48, 168, 336 hours post aflibercept infusion on Day 1 of Cycle 1 for participants with additional sampling|Intent-to-Treat (ITT) population included all registered participants.||mcg/mL||Standard Deviation|Mean
659297|NCT01882868|Secondary|Aflibercept Immunogenicity Assessment: Number of Participants With Positive Sample(s) in the Anti-drug Antibodies (ADA) Assay and in the Neutralizing Anti-drug Antibodies (NAb) Assay|Blood samples of participants were analyzed by using a titer-based, bridging immunoassay developed and validated to detect aflibercept ADA in human serum. Samples with positive antibody levels were further analyzed using a validated, non-quantitative, competitive ligand binding assay to detect NAb.|Baseline, at any time post baseline and 90 days after the last dose of aflibercept|The safety population (AT population) included all registered participants who received at least 1 (even if incomplete) infusion of study treatment. Here 'n' signifies number of participants with available data for specified category.||participants|||Number
659298|NCT01882868|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs)|Adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily have to have a causal relationship with the treatment. TEAEs were defined as AEs that developed or worsened during the on-­treatment period which was defined as the period from the time of first dose of study treatment until 30 days after the last dose of study treatment.|First dose (Day 1 of Cycle 1) of study treatment up to end of treatment visit (30 days after last dose of study treatment) (maximum duration: 77 weeks)|The safety population (AT population) included all registered participants who received at least 1 (even if incomplete) infusion of study treatment.||participants|||Number
659299|NCT01882868|Secondary|Overall Survival (OS)|OS was defined as the time interval from the date of first study drug administration to the date of death due to any cause. If death was not observed, the participant was censored at the last date the participant was known to be alive or the study cut-off date, whichever was first. OS was estimated by Kaplan-Meier estimates.|Baseline up to death or study cut­-off (maximum duration: 24.7 months)|The safety population (AT population) included all registered participants who received at least 1 (even if incomplete) infusion of study treatment.||months||95% Confidence Interval|Median
659300|NCT01882868|Secondary|Progression Free Survival (PFS)|PFS was defined as the time interval from the date of first study drug administration to the date of first observation of DP or death due to any cause, whichever came first. If death or progression was not observed, the participant was censored at the date of participant’s last valid progression-free tumor assessment prior to the study cut-off date. DP for PFS was assessed by the IRRC based on tumor imaging according to RECIST 1.1. Progression in disease was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study with absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. PFS was estimated by Kaplan-Meier estimates.|Baseline and every 6 weeks until DP or death, due to any cause (maximum duration: 16.4 months)|The safety population (all treated [AT] population) included all registered participants who received at least 1 (even if incomplete) infusion of study treatment.||months||95% Confidence Interval|Median
659301|NCT01882868|Primary|Percentage of Participants With Overall Response|Overall response in participants was defined as the percentage of participants with confirmed complete response (CR) or partial response (PR) assessed by an independent radiological review committee (IRRC) according to response evaluation criteria in solid tumors (RECIST) version 1.1. CR was defined as disappearance of all target lesions; any lymph node (target or non-target) must have reduction in the short axis to <10 mm; PR was defined as at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. Percentage of participants with overall response and the 95% confidence interval (CI) were provided. The 95% CI was calculated using normal approximation.|Baseline and every 6 weeks until DP (maximum duration: 16.4 months)|EP population: all registered participants with measurable disease at study entry & with at least 1 valid post-baseline tumor evaluation. Participants who died due to DP or had documented radiological progressive disease before first post-baseline imaging evaluation were also included.||percentage of participants||95% Confidence Interval|Number
659302|NCT01882725|Secondary|Change in Skin Surface Temperature on the Hind Foot|"Skin surface temperature on the hind foot was recorded in degrees using an infrared thermometer. Change in skin surface temperature in degrees was calculated as the change in measurements before the first procedure administration (baseline) to after the sixth and final procedure administration. It was pre-determined that a minimum mean increase in skin surface temperature of +2.5 degrees across the procedure administration phase would be considered clinically meaningful.
A positive (+) change indicates that the skin surface temperature increased across the procedure administration phase and is positive for study efficacy.
A negative (-) change indicates that the skin surface temperature decreased across the procedure administration phase and is negative for study efficacy."|baseline and 3 weeks|||Degrees Farenheit||Standard Deviation|Mean
659303|NCT01882725|Primary|Change in Skin Perfusion Pressure (SPP)|"Skin Perfusion Pressure (SPP) measured peripheral microcirculation or skin perfusion using a laser Doppler sensor and a pressure cuff to evaluate reactive hyperemia, the transient increase in blood flow that occurs following a brief period of ischemia. The SPP value was measured in mmHg.
The per cent (%) change in mean Skin Perfusion Pressure (SPP) in mmHg was calculated as the % change in measurements from before the first procedure administration with the Erchonia® HPS Laser to after the sixth and final procedure administration. It was pre-determined that a minimum mean change in % SPP of +10% or greater across the evaluation period would be considered clinically meaningful.
A positive (+) change indicates that SPP increased across the procedure administration phase and is positive for study efficacy.
A negative (-) change indicates that SPP decreased across the procedure administration phase and is negative for study efficacy."|baseline and 3 weeks|||percentage of change||Standard Deviation|Mean
659304|NCT01882647|Other Pre-specified|Change in Percent Body Surface Area (% BSA) With Active Psoriasis at Day 15|The investigator will use the assumption that 1% BSA is approximately equal to the surface area of the subject's palm and fingers, with the fingers extended yet grouped together, creating a flat oval-like surface area.|Day 15|Analysis shown is based on the Intent-to-Treat (ITT) population at Day 15 and compared to baseline. ITT was defined as all enrolled participants who were randomized and applied at least one dose of the test article. Only participants with observed values are reported.||Change in %BSA||Standard Deviation|Mean
659305|NCT01882647|Other Pre-specified|Change From Baseline in Pruritus Score at Day 15|Pruritus scale will be used to assess the subjective and multidimensional experience of the subject's pruritus (itching) during the previous two weeks at Baseline and Day 15. Possible scores range from 5 (no pruritus) to 25 (most severe pruritus).|Baseline and Day 15|Analysis shown is based on the Intent-to-Treat (ITT) population, defined as all enrolled participants who were randomized and applied at least one dose of the test article. Only participants with observed values are reported.||units on a scale||Standard Deviation|Mean
659306|NCT01882647|Other Pre-specified|"Percentage of Subjects Rated a Treatment Success for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation) at Day 8"|"Interim analysis of clinical signs of psoriasis. Treatment success for each of the clinical signs of psoriasis (scaling, erythema and plaque elevation) at Day 8 as defined in the secondary outcome measure."|Day 8|Analysis shown is based on the Intent-to-Treat (ITT) population, defined as all enrolled participants who were randomized and applied at least one dose of the test article. Only participants with observed values are reported.||percentage of participants|||Number
659307|NCT01882647|Other Pre-specified|"Percentage of Subjects With IGA Treatment Success at Day 8"|"Interim analysis of IGA. Treatment success and IGA as defined in the primary outcome measure."|Day 8|Analysis shown is based on the Intent-to-Treat (ITT) population, defined as all enrolled participants who were randomized and applied at least one dose of the test article. Only participants with observed values are reported.||percentage of participants|||Number
659308|NCT01882647|Secondary|"The Percentage of Subjects Rated a Treatment Success for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation)"|"A static assessment of the overall or average degree of severity of each of three key characteristics present within all of the subject's psoriatic lesions. Treatment success is defined as a score of 0 or 1 representing cleared or almost cleared at Day 15 with at least a two grade decrease in severity score relative to Baseline. Each clinical sign of psoriasis is measured on a 5-point scale, ranging from 0 (clear) to 4 (severe/very severe)."|Day 15|Analysis shown is based on the Intent-to-Treat (ITT) population, defined as all enrolled participants who were randomized and applied at least one dose of the test article.||percentage of participants|||Number
659309|NCT01882647|Primary|"The Percentage of Subjects Rated a Treatment Success Based on the Investigator's Global Assessment (IGA)"|"The IGA score is a static evaluation of the overall or average degree of severity of a subject's disease, taking into account all of the subject's psoriatic lesions. Treatment success is defined as a score of 0 or 1 representing cleared or almost cleared at Day 15 with at least a two grade decrease in severity score relative to Baseline. IGA is measured on a 5-point scale, ranging from 0 (clear) to 4 (severe/very severe)."|Day 15|All subjects were classified into the following datasets: intent-to-treat (ITT), per protocol (PP), and safety populations. Analysis shown is based on the ITT population, defined as all enrolled participants who were randomized and applied at least one dose of the test article.||percentage of participants|||Number
659310|NCT01882543|Other Pre-specified|AQX-1125 Concentrations in Plasma and Urine (Trough Values)|AQX-1125 Plasma and Urine Concentrations were measured at week 4 and week 6.|Week 4 and Week 6|The intent-to-treat analysis population (ITT) is the set of subjects who were randomized and received at least one dose of study medication.||ng/mL||Standard Deviation|Mean
659311|NCT01882543|Secondary|Voiding Frequency as Recorded by Diary Over a 24 Hour Period|For a 24-hour period (within 3 days of the subsequent visit), subjects recorded the frequency of each void prior to visit. The outcome measure was the change from baseline at week 6.|Baseline to Week 6|The intent-to-treat analysis population (ITT) is the set of subjects who were randomized and received at least one dose of study medication.||number of voids||Standard Error|Mean
659312|NCT01882543|Secondary|Short Form 12 Version 2.0 Health Survey [SF-12v2] Questionnaire|Change from baseline to week 6 in the SF-12v2 questionnaire. Two parameters, PCS (physical component summary) and MCS (mental component summary) were calculated. Both components scores range from 0 to 100 with higher scores indicating better Quality of Life.|Baseline to Week 6|The intent-to-treat analysis population (ITT) is the set of subjects who were randomized and received at least one dose of study medication.||units on a scale||Standard Error|Mean
659313|NCT01882543|Secondary|O'Leary-Sant Interstitial Cystitis Symptom Index/Problem Index [ICSI/PI]|Change from baseline to week 6 in the O'Leary Sant Symptom and Problem Index combined total scores. Both the ICSI and ICPI consist of 4 questions with responses for the ICSI rated on a scale of 0-5 (maximum score of 20, with a higher score indicating worse symptoms) and for the ICPI on a scale of 0-4 (maximum score of 16, with a higher score indicating worse symptoms). For the combined ICSI/PI the maximum score is 36, with a higher score indicating worse symptoms.|Baseline to Week 6|The intent-to-treat analysis population (ITT) is the set of subjects who were randomized and received at least one dose of study medication.||units on a scale||Standard Error|Mean
659314|NCT01882543|Secondary|Bladder Pain/Interstitial Cystitis Symptom Score [BPIC-SS]|Change in baseline to week 6 in the BPIC-SS participant reported questionnaire total score. The total BPIC-SS score ranges from 0-38, with a higher score indicative of worse symptoms. A score of 19 or more was considered to be discriminating between IC/BPS and overactive bladder at screening.|Baseline to Week 6|The intent-to-treat analysis population (ITT) is the set of subjects who were randomized and received at least one dose of study medication.||units on a scale||Standard Error|Mean
659315|NCT01882543|Secondary|Change From Baseline in the Maximum Bladder Pain Score (Clinic)|Change from baseline to week 6 in the maximum daily bladder pain score using a standardized 11-point numerical rating scale (NRS) recorded at study visits. The 11-point NRS ranges from 0-10 with 0 indicating 'no pain' and 10 indicating 'worst pain'.|Baseline to Week 6|The intent-to-treat analysis population (ITT) is the set of subjects who were randomized and received at least one dose of study medication.||units on a scale||Standard Error|Mean
659316|NCT01882543|Secondary|Change From Baseline in the Average Bladder Pain Score (Clinic)|Change from baseline to week 6 in the average daily bladder pain score using a standardized 11-point numerical rating scale (NRS) recorded at study visit. The 11-point NRS ranges from 0-10 with 0 indicating 'no pain' and 10 indicating 'worst pain'.|Baseline to Week 6|The intent-to-treat analysis population (ITT) is the set of subjects who were randomized and received at least one dose of study medication.||units on a scale||Standard Error|Mean
659317|NCT01882543|Secondary|Change From Baseline in the Maximum Daily Bladder Pain Score (e-Diary)|Change from baseline to week 6 in the maximum daily bladder pain score using a standardized 11-point numerical rating scale (NRS) recorded by e-diary. The 11-point NRS ranges from 0-10 with 0 indicating 'no pain' and 10 indicating 'worst pain'.|Baseline to Week 6|The intent-to-treat analysis population (ITT) is the set of subjects who were randomized and received at least one dose of study medication.||units on a scale||Standard Error|Mean
659318|NCT01882543|Primary|Change From Baseline in the Average Daily Bladder Pain Score (e-Diary)|Change from baseline to week 6 in the average daily bladder pain score using a standardized 11-point numerical rating scale (NRS) recorded by e-diary. The 11-point NRS ranges from 0-10 with 0 indicating 'no pain' and 10 indicating 'worst pain'.|Baseline to Week 6|The intent-to-treat analysis population (ITT) is the set of subjects who were randomized and received at least one dose of study medication.||units on a scale||Standard Error|Mean
659319|NCT01882465|Primary|Corneal Staining|Corneal staining was evaluated in 5 corneal regions (Central, Inferior, Nasal, Temporal and Superior) using Sodium Fluorescein strips. The corneal Staining was graded using the scale Grade 0: No Staining, Grade 1: Trace(Minimal superficial staining or stippling), Grade 2: Mild (Regional or diffuse punctate staining), Grade 3:Moderate(Significant dense coalesced staining, corneal abrasion or foreign body tracks.), Grade 4 Severe(Severe abrasions greater than 2 mm in diameter, ulcerations, epithelial loss, or full thickness abrasion.). The total was calculated by using the sum across all regions by time point. The range for the total grade for each time point would be 0-20. The total average grade for each lens and time point was evaluated as an average change from baseline level of corneal staining.|20 minutes and 7 hours post lens fitting|All subjects that completed every study visit without a major protocol deviation.||units on a scale|Subject Eyes|Standard Deviation|Mean
659320|NCT01882439|Secondary|Change From Baseline in Score Evaluating Spondylitis Using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI): Months 1, 3, 6|BASDAI is a validated self-assessment tool used to determine disease activity in participants with ankylosing spondylitis. Utilizing a VAS of 0-10 (0=none and 10=very severe) participants answered 6 questions measuring discomfort, pain, and fatigue. The final BASDAI score averaged the individual assessments for a final score ranging 0-10cm, with higher scores representing more severe ankylosing spondylitis disease activity. n=number of participants evaluable at each visit.|Months 1, 3, 6|All participants who were randomized, received at least 1 dose of study drug with presence of spondylitis at screening and baseline BASDAI score >0 cm, and were evaluable.||cm||Standard Error|Least Squares Mean
659321|NCT01882439|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Impact Domain Score: Months 1, 3, 6|FACIT-F is a 13-item questionnaire, with each item score ranging from 0 to 4. Three endpoints are derived: change in FACIT-F total score, change in FACIT-F experience domain score, and change in FACIT-F impact domain score. FACIT-F total score (range 0-52) is calculated by summing the 13 items. FACIT-F experience domain score (range 0-20) is calculated by summing 5 items : I feel fatigued, I feel weak all over, I feel listless (“washed out”), I feel tired, and I have energy, while FACIT-F impact domain score (range 0-32) is calculated by summing the remaining 8 items. All responses are added with equal weight to obtain the total score. Higher scores represent better (less) fatigue impact on daily functioning. n=number of participants evaluable at each visit.|Months 1, 3, 6|All participants who were randomized, received at least 1 dose of study drug and were evaluable.||Units on a scale||Standard Error|Least Squares Mean
659322|NCT01882439|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Experience Domain Score: Months 1, 3, 6|FACIT-F is a 13-item questionnaire, with each item score ranging from 0 to 4. Three endpoints are derived: change in FACIT-F total score, change in FACIT-F experience domain score, and change in FACIT-F impact domain score. FACIT-F total score (range 0-52) is calculated by summing the 13 items. FACIT-F experience domain score (range 0-20) is calculated by summing 5 items : I feel fatigued, I feel weak all over, I feel listless (“washed out”), I feel tired, and I have energy, while FACIT-F impact domain score (range 0-32) is calculated by summing the remaining 8 items. All responses are added with equal weight to obtain the total score. Higher scores represent better (less) fatigue experience. n=number of participants evaluable at each visit.|Months 1, 3, 6|All participants who were randomized, received at least 1 dose of study drug and were evaluable.||Units on a scale||Standard Error|Least Squares Mean
659344|NCT01882439|Secondary|Change From Baseline in Physician’s Global Assessment of Psoriasis (PGA-PsO) Response: Months 1, 3, and 6|The PGA-PsO is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are rated separately over the whole body according to a 5-point severity scale, scored as 0=none; 1, 2, 3, or 4=most severe. The severity rating scores are summed and the average taken; the total average is rounded to the nearest whole number score to determine the PGA-PsO score on a scale of 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe). n=number of participants evaluable at each visit.|Months 1, 3, and 6|All participants who were randomized, received at least 1 dose of study drug with baseline PGA-PsO >0, and were evaluable.||Units on a scale||Standard Error|Least Squares Mean
659323|NCT01882439|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Total Score: Months 1, 3, 6|FACIT-F is a 13-item questionnaire, with each item score ranging from 0 to 4. Three endpoints are derived: change in FACIT-F total score, change in FACIT-F experience domain score, and change in FACIT-F impact domain score. FACIT-F total score (range 0-52) is calculated by summing the 13 items. FACIT-F experience domain score (range 0-20) is calculated by summing 5 items : I feel fatigued, I feel weak all over, I feel listless (“washed out”), I feel tired, and I have energy, while FACIT-F impact domain score (range 0-32) is calculated by summing the remaining 8 items. All responses are added with equal weight to obtain the total score. Higher scores represent better fatigue status. n=number of participants evaluable at each visit.|Months 1, 3, 6|All participants who were randomized, received at least 1 dose of study drug and were evaluable.||Units on a scale||Standard Error|Least Squares Mean
659324|NCT01882439|Secondary|Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Patient's Health State Today: Months 1, 3, 6|The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm VAS (similar to a thermometer) for recording an individual’s rating for their current health-related quality of life state, with a higher value representing better health status. n=number of participants evaluable at each visit.|Months 1, 3, 6|All participants who were randomized, received at least 1 dose of study drug and were evaluable.||mm||Standard Error|Least Squares Mean
659325|NCT01882439|Secondary|Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Anxiety/Depression: Months 1, 3, 6|The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm VAS (similar to a thermometer) for recording an individual’s rating for their current health-related quality of life state, with a higher value representing better health status. n=number of participants evaluable at each visit.|Months 1, 3, 6|All participants who were randomized, received at least 1 dose of study drug and were evaluable.||Units on a scale||Standard Error|Least Squares Mean
659326|NCT01882439|Secondary|Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Pain/Discomfort: Months 1, 3, 6|The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm VAS (similar to a thermometer) for recording an individual’s rating for their current health-related quality of life state, with a higher value representing better health status. n=number of participants evaluable at each visit.|Months 1, 3, 6|All participants who were randomized, received at least 1 dose of study drug and were evaluable.||Units on a scale||Standard Error|Least Squares Mean
659327|NCT01882439|Secondary|Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Usual Activities: Months 1, 3, 6|The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm VAS (similar to a thermometer) for recording an individual’s rating for their current health-related quality of life state, with a higher value representing better health status. n=number of participants evaluable at each visit.|Months 1, 3, 6|All participants who were randomized, received at least 1 dose of study drug and were evaluable.||Units on a scale||Standard Error|Least Squares Mean
659328|NCT01882439|Secondary|Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Self-Care: Months 1, 3, 6|The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm VAS (similar to a thermometer) for recording an individual’s rating for their current health-related quality of life state, with a higher value representing better health status. n=number of participants evaluable at each visit.|Months 1, 3, 6|All participants who were randomized, received at least 1 dose of study drug and were evaluable.||Units on a scale||Standard Error|Least Squares Mean
659329|NCT01882439|Secondary|Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Mobility: Months 1, 3, 6|The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm VAS (similar to a thermometer) for recording an individual’s rating for their current health-related quality of life state, with a higher value representing better health status. n=number of participants evaluable at each visit.|Months 1, 3, 6|All participants who were randomized, received at least 1 dose of study drug and were evaluable.||Units on a scale||Standard Error|Least Squares Mean
659447|NCT01880086|Secondary|Androgen Deficiency in the Aging Male (ADAM) Questionnaire|Overall, study subjects will be assessed for possible change in hypogonadal, sexual function, and pain symptoms. Minimum score is 0 and maximum score is 10. 0 is most symptomatic, and 10 is least symptomatic.|3 months post initial visit|||scores on a scale||Standard Deviation|Mean
659330|NCT01882439|Secondary|Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Mental Health Domain: Months 1, 3, 6|The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 5-item mental health scale includes 1 or more items from each of 4 major mental health dimensions: anxiety, depression, loss of behavioral/emotional control, and psychological well-being. All items are answered on a 5-point scale. The domain scores were scored using the US 1998 general population norms. The resulting norm-based T-scores for both the SF36 version 2 & SF36 health domain scales & component summary measures have means of 50 & standard deviations of 10. A higher mental health domain score represents better mental health functioning. n=number of participants evaluable at each visit.|Months 1, 3, 6|All participants who were randomized, received at least 1 dose of study drug and were evaluable.||T-scores||Standard Error|Least Squares Mean
659331|NCT01882439|Secondary|Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Role-emotional Domain: Months 1, 3, 6|The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 3-item role-emotional scale assesses mental health-related role limitations in terms of a) time spent in work or other usual activities; b) amount of work or activities accomplished; c) care with which work or other activities were performed. All 3 items are answered on a 5-point scale. The domain scores were scored using the US 1998 general population norms. The resulting norm-based T-scores for both the SF36 version 2 & SF36 health domain scales & component summary measures have means of 50 & standard deviations of 10. A higher role-emotional domain score represents better role-emotional functioning. n=number of participants evaluable at each visit.|Months 1, 3, 6|All participants who were randomized, received at least 1 dose of study drug and were evaluable.||T-scores||Standard Error|Least Squares Mean
659332|NCT01882439|Secondary|Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Social Functioning Domain: Months 1, 3, 6|The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 2-item social functioning scale assesses health-related effects on quantity and quality of social activities. The domain scores were scored using the US 1998 general population norms. The resulting norm-based T-scores for both the SF36 version 2 & SF36 health domain scales & component summary measures have means of 50 & standard deviations of 10. A higher social functioning domain score represents better social functioning. n=number of participants evaluable at each visit.|Months 1, 3, 6|All participants who were randomized, received at least 1 dose of study drug and were evaluable.||T-scores||Standard Error|Least Squares Mean
659333|NCT01882439|Secondary|Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Vitality Domain: Months 1, 3, 6|The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 4-item measure of vitality captures a broad range of subjective evaluations of well-being from feelings of tiredness and being worn out to feeling full of energy all or most of the time. The domain scores were scored using the US 1998 general population norms. The resulting norm-based T-scores for both the SF36 version 2 & SF36 health domain scales & component summary measures have means of 50 & standard deviations of 10. A higher vitality domain score represents better vitality. n=number of participants evaluable at each visit.|Months 1, 3, 6|All participants who were randomized, received at least 1 dose of study drug and were evaluable.||T-scores||Standard Error|Least Squares Mean
659334|NCT01882439|Secondary|Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): General Health Domain: Months 1, 3, 6|The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The general health scale consists of 5 items including a rating of health and 4 items addressing the respondent’s view and expectations of his or her health. The domain scores were scored using the US 1998 general population norms. The resulting norm-based T-scores for both the SF36 version 2 & SF36 health domain scales & component summary measures have means of 50 & standard deviations of 10. A higher general health domain score represents better general health perceptions. n=number of participants evaluable at each visit.|Months 1, 3, 6|All participants who were randomized, received at least 1 dose of study drug and were evaluable.||T-scores||Standard Error|Least Squares Mean
659335|NCT01882439|Secondary|Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Bodily Pain Domain: Months 1, 3, 6|The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The bodily pain scale comprises of 2 items pertaining to the intensity of bodily pain and extent of interference with normal work activities. The domain scores were scored using the US 1998 general population norms. The resulting norm-based T-scores for both the SF36 version 2 & SF36 health domain scales & component summary measures have means of 50 & standard deviations of 10. A higher bodily pain domain score represents less bodily pain. n=number of participants evaluable at each visit.|Months 1, 3, 6|All participants who were randomized, received at least 1 dose of study drug and were evaluable.||T-scores||Standard Error|Least Squares Mean
659336|NCT01882439|Secondary|Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Role-physical Domain: Months 1, 3, 6|SF-36v2 acute is a 36-item measure evaluating 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. The 4-item role-physical scale covers an array of physical health-related role limitations, including: a) limitations in the kind of work or other usual activities; b) reductions in the amount of time spent on work or other usual activities; c) difficulty performing work or other usual activities; & d) accomplishing less. Items in the role-physical scale are answered on a 5-point scale. The domain scores were scored using the US 1998 general population norms. The resulting norm-based T-scores for both the SF36 version 2 & SF36 health domain scales & component summary measures have means of 50 & standard deviations of 10. A higher role-physical domain score represents better role-physical functioning. n=number of participants evaluable at each visit.|Months 1, 3, 6|All participants who were randomized, received at least 1 dose of study drug and were evaluable.||T-scores||Standard Error|Least Squares Mean
659448|NCT01880086|Secondary|Other Hormonal Profile (Change From Baseline)|Luteinizing hormone (LH)|3 months post initial visit|||IU/mL||Standard Deviation|Mean
659337|NCT01882439|Secondary|Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Physical Functioning Domain: Months 1, 3, 6|SF-36v2 acute is a 36-item measure evaluating 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. The 10 items of the physical functioning scale represent levels & kinds of limitations between extremes of physical activities, including lifting & carrying groceries; climbing stairs; bending, kneeling, or stooping; walking moderate distances; self-care limitations. The physical functioning items capture the presence & extent of physical limitations using a 3-level response continuum. The domain scores were scored using the US 1998 general population norms. The resulting norm-based T-scores for both the SF36 version 2 & SF36 health domain scales & component summary measures have means of 50 & standard deviations of 10. A higher physical functioning domain score represents better physical functioning. n=number of participants evaluable at each visit.|Months 1, 3, 6|All participants who were randomized, received at least 1 dose of study drug and were evaluable.||T-scores||Standard Error|Least Squares Mean
659338|NCT01882439|Secondary|Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Mental Component Summary Score: Months 1, 3, 6|The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The health domains are aggregated into two summary scores known as the PCS score and the MCS score. Normalized domain scores, PCS and MCS scores are used in the analyses. The component and domain scores were scored using the US 1998 general population norms. The resulting norm-based T-scores for both the SF36 version 2 and SF36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher MCS score represents better mental health status. n=number of participants evaluable at each visit.|Months 1, 3, 6|All participants who were randomized, received at least 1 dose of study drug and were evaluable.||T-scores||Standard Error|Least Squares Mean
659339|NCT01882439|Secondary|Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Physical Component Summary Score: Months 1, 3, 6|The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The health domains are aggregated into two summary scores known as the physical component summary (PCS) score and the mental component summary (MCS) score. Normalized domain scores, PCS and MCS scores are used in the analyses. The component and domain scores were scored using the United States (US) 1998 general population norms. The resulting norm-based T-scores for both the SF36 version 2 and SF36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher PCS score represents better physical health status. n=number of participants evaluable at each visit.|Months 1, 3, 6|All participants who were randomized, received at least 1 dose of study drug, and were evaluable.||T-scores||Standard Error|Least Squares Mean
659340|NCT01882439|Secondary|Change From Baseline in the Leeds Enthesitis Index (LEI): Months 1, 3, and 6|Enthesitis is inflammation in the tendon, ligament, and joint capsule fiber insertion into bone. The LEI assesses enthesitis in 6 sites. Tenderness is recorded as either present (1) or absent (0) for each of the 6 sites, for a total score of 0-6. Higher score indicates greater severity of enthesitis. n=number of participants evaluable at each visit.|Months 1, 3, and 6|All participants who were randomized, received at least 1 dose of study drug with baseline LEI >0, and were evaluable.||Units of scale||Standard Error|Least Squares Mean
659341|NCT01882439|Secondary|Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index: Months 1, 3, and 6|The SPARCC Enthesitis Index identifies the presence or absence of tenderness at 16 enthesial sites, including the bilateral Achilles tendons, plantar fascia insertion at the calcaneus, patellar tendon insertion at the base of the patella, quadriceps insertion into the superior border of the patella, supraspinatus insertion into the greater tuberosity of the humerus, and medial and lateral epicondyles. On examination, tenderness is recorded as present (1) or absent (0) for each of the 16 sites, with an overall total score ranging from 0 to 16. Higher score indicates a greater number of sites that are affected by enthesitis. n=number of participants evaluable at each visit.|Months 1, 3, and 6|All participants who were randomized, received at least 1 dose of study drug with baseline SPARCC Enthesitis Score >0, and were evaluable.||Units of scale||Standard Error|Least Squares Mean
659342|NCT01882439|Secondary|Change From Baseline in Dactylitis Severity Score (DSS): Months 1, 3, and 6|Dactylitis is characterized by swelling of the entire finger or toe. The DSS is a function of finger circumference and tenderness, assessed and summed across all dactylitic digits. The severity of dactylitis is scored on a scale of 0-3, where 0=tenderness and 3=extreme tenderness in each digit of the hands and feet. The range of total dactylitis scores for a participant is 0-60. Higher score indicates greater degree of tenderness. n=number of participants evaluable at each visit.|Months 1, 3, and 6|All participants who were randomized, received at least 1 dose of study drug with baseline DSS >0, and were evaluable.||Units on a scale||Standard Error|Least Squares Mean
659343|NCT01882439|Secondary|Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response: Months 1, 3, and 6|PASI determines psoriasis severity based on lesion severity and percentage of body surface area (BSA) affected. Lesion severity is assessed for erythema, induration, and scaling evaluated separately for the head and neck, upper limbs, trunk, and lower limbs and then rated for each body area according to a 5 point scale: 0=no involvement; 1=slight; 2=moderate; 3=marked; 4=very marked. BSA involvement is the extent (%) of body area affected by psoriasis and is assigned a numerical score: 0=no involvement; 1=0% to 9%; 2=10% to 29%; 3=30% to 49%; 4=50% to 69%; 5=70% to 89%; 6=90% to 100%. In each area, the sum of the severity rating scores is multiplied by the score representing the percentage of this area involved by psoriasis, multiplied by a weighting factor (head 0.1; upper limbs 0.2; trunk 0.3; lower limbs 0.4). The sum of the numbers obtained for each of the 4 body areas is the PASI. PASI75 is defined as a 75% reduction from baseline in PASI. n=number of responders.|Months 1, 3, and 6|All participants who were randomized and received at least 1 dose of study drug with PASI >0 and BSA ≥3% at baseline.||Percentage of participants|||Number
659409|NCT01880723|Secondary|Diffusion Capacity of the Lungs for Carbon Monoxide|Using the rebreathe technique the diffusion capacity of the lungs for carbon monoxide and nitric oxide were measured, and this allowed for the determination of alveolar-capillary membrane conductance and pulmonary capillary blood volume. These measurements were made at baseline and 30-, 60- and 90-minutes post albuterol administration in cystic fibrosis and healthy subjects.|baseline, 30-, 60- and 90-minutes post albuterol administration|||mL/min/mmHg||Standard Deviation|Mean
659345|NCT01882439|Secondary|Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC): Week 2, Months 1, 2, 3, 4, and 6|The PsARC covers 4 measures: Tender joint count, swollen joint count, the Physician's Global Assessment of Arthritis, and the Patient's Global Assessment of Arthritis. The PsARC response is defined as improvement in 2 of 4 items, 1 of which must be joint pain or swelling, without worsening in any measure. Improvement criteria: ≥20% improvement in Physician's Global Assessment of Arthritis; ≥20% improvement in Patient's Global Assessment of Arthritis; ≥30% improvement in tender joint count; and ≥30% improvement in swollen joint count. n=number of responders.|Week 2, Months 1, 2, 3, 4, and 6|All participants who were randomized and received at least 1 dose of study drug.||Percentage of participants|||Number
659346|NCT01882439|Secondary|Change From Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Tender/Painful Joint Count: Month 3|Tender/painful joint counts are considered the most specific quantitative clinical measure used to assess the status of participants with inflammatory types of arthritis. Sixty eight (68) joints were assessed by a blinded assessor to determine the number of joints that were considered tender or painful.|Month 3|All participants who were randomized, received at least 1 dose of study drug, and were evaluable.||Joints||Standard Error|Least Squares Mean
659347|NCT01882439|Secondary|Change From Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Swollen Joint Count: Month 3|Swollen joint counts are considered the most specific quantitative clinical measure used to assess the status of participants with inflammatory types of arthritis. Sixty six (66) joints were assessed by a blinded assessor to determine the number of joints that were considered swelling.|Month 3|All participants who were randomized, received at least 1 dose of study drug, and were evaluable.||Joints||Standard Error|Least Squares Mean
659348|NCT01882439|Secondary|Change From Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Physician's Global Assessment of Arthritis: Month 3|The blinded investigator or qualified assessor assessed how the participant’s overall arthritis appeared at the time of the visit. This was an evaluation based on the participant’s disease signs, functional capacity and physical examination, and was independent of the Patient’s Global Assessment of Arthritis. The investigator’s response was recorded using a 100 mm VAS by placing a mark on the scale between 0 (very good) and 100 (very poor).|Month 3|All participants who were randomized, received at least 1 dose of study drug, and were evaluable.||mm||Standard Error|Least Squares Mean
659349|NCT01882439|Secondary|Change From Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Patient's Global Assessment of Arthritis: Month 3|Participants answered the following question, “Considering all the ways your arthritis affects you, how are you feeling today?” The participant’s response was recorded using a 100 mm VAS by placing a mark on the scale between 0 (very well) and 100 (very poorly).|Month 3|All participants who were randomized, received at least 1 dose of study drug, and were evaluable||mm||Standard Error|Least Squares Mean
659350|NCT01882439|Secondary|Change From Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Patient's Assessment of Arthritis Pain: Month 3|Participants assessed the severity of their arthritis pain using a 100 mm visual analog scale (VAS) by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.|Month 3|All participants who were randomized, received at least 1 dose of study drug, and were evaluable.||mm||Standard Error|Least Squares Mean
659351|NCT01882439|Secondary|Change From Baseline in American College of Rheumatology (ACR) Response Criteria Components: C-reactive Protein (CRP) Levels: Month 3|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Month 3|All participants who were randomized, received at least 1 dose of study drug, and were evaluable||mg/L||Standard Error|Least Squares Mean
659352|NCT01882439|Secondary|Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score: Week 2 and Months 1, 2, 4, and 6|The HAQ-DI assesses the difficulty a patient has had in the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2-3 items. For each question, level of difficulty is scored from 0 to 3 with 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. The score for each domain is the maximum (worst) score from the items/questions within the domain. Higher score indicates greater disability. Overall score was computed as the sum of the domain scores divided by the number of domains answered. The total possible score ranged from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty. Higher overall score indicates greater disability. n=number of participants evaluable at each visit.|Week 2 and Months 1, 2, 4, and 6|All participants who were randomized, received at least 1 dose of study drug, and were evaluable.||Units on scale||Standard Error|Least Squares Mean
659353|NCT01882439|Secondary|Percentage of Participants Meeting American College of Rheumatology Response Criteria Greater Than or Equal to (≥) 20% (ACR20): Week 2 and Months 1, 2, 4, and 6|ACR20 was calculated as a ≥20% improvement from baseline in tender /painful and swollen joint counts and ≥20% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, HAQ-DI, and CRP. n=number of responders.|Week 2 and Months 1, 2, 4, and 6|All participants who were randomized and received at least 1 dose of study drug.||Percentage of participants|||Number
659354|NCT01882439|Secondary|Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, and 6|ACR70 was calculated as a ≥70% improvement from baseline in tender /painful and swollen joint counts and ≥70% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, HAQ-DI, and CRP. n=number of responders.|Week 2 and Months 1, 2, 3, 4, and 6|All participants who were randomized and received at least 1 dose of study drug.||Percentage of participants|||Number
659407|NCT01880723|Primary|Net Exhaled Chloride|"The calculation of net chloride efflux was used to account for the paracellular reabsorption of Cl- that will follow the reabsorption of Na+ to maintain electroneutral ion flux. Thus, the net chloride efflux calculation used was the gross chloride concentration plus the absolute value of the percent change in sodium from baseline multiplied by the gross chloride concentration for each time point:
Net Cl- efflux – [Cl- X-min post] + (([Na+ X-min post]-[Na+Baseline])/ [Na+Baseline]) x [Cl- X-min post])"|baseline to 90 minutes post albuterol administration|||mmol/L||Standard Deviation|Mean
659355|NCT01882439|Secondary|Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, and 6|ACR50 was calculated as a ≥50% improvement from baseline in tender /painful and swollen joint counts and ≥50% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, HAQ-DI, and CRP. n=number of responders.|Week 2 and Months 1, 2, 3, 4, and 6|All participants who were randomized and received at least 1 dose of study drug.||Percentage of participants|||Number
659356|NCT01882439|Primary|Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score: Month 3|The HAQ-DI assesses the difficulty a patient has had in the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2-3 items. For each question, level of difficulty is scored from 0 to 3 with 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. The score for each domain is the maximum (worst) score from the items/questions within the domain. Higher score indicates greater disability. Overall score was computed as the sum of the domain scores divided by the number of domains answered. The total possible score ranged from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty. Higher overall score indicates greater disability.|Month 3|All participants who were randomized, received at least 1 dose of study drug, and were evaluable.||Units on a scale||Standard Error|Least Squares Mean
659357|NCT01882439|Primary|Percentage of Participants Meeting American College of Rheumatology Response Criteria Greater Than or Equal to (≥) 20% (ACR20): Month 3|ACR20 was calculated as a ≥20% improvement from baseline in tender/painful and swollen joint counts and ≥20% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, Health Assessment Questionnaire - Disability Index (HAQ-DI), and C-reactive protein (CRP).|Month 3|All participants who were randomized and received at least 1 dose of study drug.||Percentage of participants|||Number
659358|NCT01882413|Secondary|Percentage of Participants With Elevated MMP-9 and an Ocular Surface Disease Index® (OSDI®) > 12, > 22 and ≥ 32|Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. The OSDI consists of 12 questions to assess visual function, ocular symptoms and environmental triggers related to dry eye. Each of the 12 questions is assessed using a 5-point scale (0=none of the time to 4=all of the time) which is converted to a total score between 0-100. OSDI total scores of 0-12=normal (best), 13-22= mild ocular surface disease, 23-32 =moderate ocular surface disease, and 33-100=severe ocular surface disease (worst).|Up to 60 Days Prior to Surgery|Participants from the Per-protocol population, all enrolled participants who completed all the study assessments without major protocol violations, with elevated MMP-9 and data available for analysis.||percentage of participants|||Number
659359|NCT01882413|Secondary|Percentage of Participants With Elevated MMP-9 With Corneal Staining Grade ≥ 1 and ≥ 2|Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Corneal Staining was evaluated as part of the slit lamp biomicroscopy examination. Eye structures and surfaces were assessed for signs of dry eye using a 5-point scale where: 0=none, 0.5=trace, 1=mild, 2=moderate and 3=severe. Higher values represent a worse outcome.|Up to 60 Days Prior to Surgery|Participants from the Per-protocol population, all enrolled participants who completed all the study assessments without major protocol violations, with elevated MMP-9 and data available for analysis.||percentage of participants|||Number
659360|NCT01882413|Secondary|Percentage of Participants With Elevated MMP-9 With Punctal Plugs|Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. A history of punctual plug usage was assessed by the investigator.|Up to 60 Days Prior to Surgery|Participants from the Per-protocol population, all enrolled participants who completed all the study assessments without major protocol violations, with elevated MMP-9 and data available for analysis.||percentage of participants|||Number
659361|NCT01882413|Secondary|Percentage of Participants With Elevated MMP-9 Who Routinely Use Artificial Tears|Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Artificial Tear usage was assessed by the investigator.|Up to 60 Days Prior to Surgery|Participants from the Per-protocol population, all enrolled participants who completed all the study assessments without major protocol violations, with elevated MMP-9 and data available for analysis.||percentage of participants|||Number
659362|NCT01882413|Secondary|Percentage of Participants With Elevated MMP-9 With at Least One Dry Eye Sign and Dry Eye Symptoms|Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Dry Eye Signs included conjunctival or corneal staining, Schirmer’s score ≤ 7mm, or Tear Film Break-up Time [TFBUT] ≤ 10 seconds with Dry eye symptoms measured by a score of at least ≥ 2 using the SESoD questionnaire. The SESoD assessed dry eye using a 5-point scale where 0= no dryness to 4= severe dryness.|Up to 60 days prior to cataract surgery|Participants from the Per-protocol population, all enrolled participants who completed all the study assessments without major protocol violations, with elevated MMP-9 and data available for analysis.||percentage of participants|||Number
659363|NCT01882413|Secondary|Percentage of Participants With Elevated MMP-9 With at Least One Dry Eye Sign Without Dry Eye Symptoms|Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Dry Eye Signs included conjunctival or corneal staining, Schirmer’s score ≤ 7 mm, or Tear Film Break-up Time [TFBUT] ≤ 10 seconds without Dry eye symptoms measured by a score of at least ≤ 1 using the SESoD questionnaire. The SESoD assessed dry eye using a 5-point scale where 0= no dryness to 4= severe dryness.|Up to 60 days prior to cataract surgery|Participants from the Per-protocol population, all enrolled participants who completed all the study assessments without major protocol violations, with elevated MMP-9 and data available for analysis.||percentage of participants|||Number
659364|NCT01882413|Secondary|Percentage of Participants With Elevated MMP-9 With Dry Eye Symptoms Without Any Signs|Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Dry eye symptoms were measured by a score of at least ≥ 2 using the SESoD questionnaire without any signs. The SESoD assesses dry eye using a 5-point scale where 0= no dryness to 4= severe dryness. Signs included conjunctival or corneal staining, Schirmer’s score ≤ 7mm, or Tear Film Break-up Time [TFBUT] ≤ 10 seconds.|Up to 60 days prior to cataract surgery|Participants from the Per-protocol population, all enrolled participants who completed all the study assessments without major protocol violations, with elevated MMP-9 and data available for analysis.||percentage of participants|||Number
659365|NCT01882413|Secondary|Percentage of Participants With Elevated MMP-9 With Dry Eye Symptoms Without Conjunctival or Corneal Staining|Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Dry eye symptoms were measured by a score of at least ≥ 2 using the Subject Evaluation of Symptoms of Dryness (SESoD) questionnaire without conjunctival or corneal staining. The SESoD assesses dry eye using a 5-point scale where 0= no dryness to 4= severe dryness. Conjunctival and Corneal Staining were evaluated as part of the slit lamp biomicroscopy examination. Eye structures and surfaces were assessed for dry eye signs using a 5-point scale where: 0=none, 0.5=trace, 1=mild, 2=moderate and 3=severe. Higher values represent a worse outcome.|Up to 60 days prior to cataract surgery|Participants from the Per-protocol population, all enrolled participants who completed all the study assessments without major protocol violations, with elevated MMP-9 and data available for analysis.||percentage of participants|||Number
659366|NCT01882413|Secondary|Percentage of Participants With Elevated MMP-9 Without Prior Diagnosis or Physician Recommended Intervention|Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Participants without a prior diagnosis of keratoconjunctivitis sicca, dry eye or tear film insufficiency or physician recommended use of topical cyclosporine, artificial tears or punctal plugs are included in the analysis.|Up to 60 days prior to cataract surgery|Participants from the Per-protocol population, all enrolled participants who completed all the study assessments without major protocol violations, with elevated MMP-9 and data available for analysis.||percentage of participants|||Number
659367|NCT01882413|Secondary|Percentage of Participants Suspected of Having Dry Eye With Elevated MMP-9|"Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Suspected of having dry eye was defined as a response of Yes to the Investigator Dry Eye History question."|Up to 60 days prior to cataract surgery|Participants from the Per-protocol population, all enrolled participants who completed all the study assessments without major protocol violations, with elevated data MMP-9 and data available for analysis.||percentage of participants|||Number
659368|NCT01882413|Primary|Percentage of Patients With a Presence of Matrix Metalloproteinase-9 (MMP-9) in the Study Eye|Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye.|Up to 60 Days Prior to Surgery|Per-protocol population included all enrolled participants who completed all the study assessments without major protocol violations.||percentage of participants|||Number
659369|NCT01882257|Other Pre-specified|Identify Clinical Features That Are Predict or Are Associated With the Severity of Sleep-disordered Breathing|Clinical features (neck and waist circumference, body mass index, level and duration of spinal cord injury, lung function tests, questionnaire results) will be analyzed to determine if certain attributes predict the presence or severity of sleep-disordered breathing.|Month 4 after enrollment||||||
659370|NCT01882257|Other Pre-specified|Short Term Effects of Noninvasive Ventilatory Support on Glucose and Lipid Metabolism|When home-based sleep testing is performed, and at 3, 6, and 12 months afterward, subjects will have blood tests to determine if treatment of sleep-disordered breathing has any effects on glucose intolerance/diabetes and/or blood cholesterol/lipid levels|Months 4-16||||||
659371|NCT01882257|Other Pre-specified|Short Term Effects of Noninvasive Ventilatory Support on Quality of Life|At month 4 of the study, and every 3 months therafter for 12 months, the subjects will complete standardized questionnaires on quality of life, focusing on general well being, mood, pain, and sleepiness.|Months 4-16||||||
659372|NCT01882257|Other Pre-specified|Short Term Effects on Daily Symptoms and Medical Events|The subjects keep daily logs of certain symptoms and events (pulmonary symptoms that require escalated care, pulmonary infections, doctor visits, hospitalizations, antibiotic use, symptoms of unstable blood pressure). These data are collected throughout the study period|Months 0-16 after enrollment||||||
659373|NCT01882257|Primary|The Frequency of Technical Errors Related to the Home-based Overnight Testing.|All testing was done overnight, and if the home-based overnight test was inadequate, that portion of the testing was repeated (also overnight).|Overnight testing (4-13 hours)|||participants|||Number
659374|NCT01882257|Primary|Prevalence of Sleep-disordered Breathing in Spinal Cord-injured Adults|After enrollment, the subject completes symptom logs for four months to collect baseline data. At that point, the home-based sleep study is performed, and the results determine whether the subject has sleep-disordered breathing. The primary outcome to be measured in this study is to determine the prevalence and type of sleep-disordered breathing in subjects with spinal cord injury. These results in turn determine the type of positive pressure device to be prescribed, as detailed in the description of the study arms. Therefore, the arm distribution is itself a primary outcome of this study.|Month 4 after enrollment|||participants|||Number
659375|NCT01882062|Secondary|Correlation Between Primary Outcome Measure and Clinical Parameters|Correlating an improvement of brain energy profile with clinical parameters in Huntington patients such as the Unified Huntington's disease rating scale (UHDRS) and total functional capacity score (TFC).|visit 1 (baseline), visit 2 (after 1 month of treatment)||12/2015||||
659376|NCT01882062|Primary|Ratio of Inorganic Phosphate (Pi) Over Phosphocreatine (PCr): Pi/PCr|"The Pi/PCr Ratio is a measure of brain metabolism and it is an index of mitochondrial oxidative regulation.
A 6-cm 31P transmit/receive surface coil (RAPID Biomedical GmbH, Rimpar, Germany) was used to collect free induction decays for 4 minutes at rest, 8 minutes during visual activation with 6-Hz red/black checkerboard flashes, and 8 minutes after stimulation. Subjects were able to focus on the flashes with a nonmagnetic mirror mounted above their eyes while all lights in the room were turned off. The Pi/PCr ratio was then calculated to determine brain response to cortical activation."|visit 1 (baseline), visit 2 (after 1 month of treatment)|||ratio||Standard Deviation|Mean
659377|NCT01881984|Secondary|Pharmacokinetic (pK)Analysis|Results from the pharmacokinetic (pK)analysis (the rate of conversion of the phenylbutyrate to phenylacetate) will also be reviewed to assess for changes pre- and post-dosing with Ravicti as well as changes in these levels at the different doses of Ravicti.|7 weeks|Due to the small sample size in this Phase I study, details on the analysis cannot be provided due to concerns with subject confidentiality.|||||
659378|NCT01881984|Primary|Metabolic Stress|Changes in the assessments of metabolic stress pre- and post-dosing with Ravicti will be the main outcome variable.|7 weeks|Due to the small sample size in this Phase I study, details on the analysis cannot be provided due to concerns with subject confidentiality.|||||
659449|NCT01880086|Primary|Serum Total Testosterone (Change From Baseline)|Morning venipuncture of serum total testosterone.|3 months post initial visit|||ng/mL||Standard Deviation|Mean
659379|NCT01881932|Primary|Proportion of Colorectal and Breast Cancer Patients in Each Arm Who Require Dose Reduction or Discontinuation Due to Chemotherapy-induced Peripheral Neuropathy.|The main objective is to assess efficacy and safety of acupuncture using Seirin acupuncture needles in colorectal and breast cancer patients who developed chemotherapy-induced peripheral neuropathy while receiving adjuvant/neoadjuvant chemotherapy. Safety will be assessed by recording side effects from acupuncture treatment. Efficacy will be assessed by measuring the proportion of patients in each arm who are required to undergo dose reduction or discontinuation due to chemotherapy-induced peripheral neuropathy.|Week 12|Zero participants analyzed due to early termination of study.|||||
659380|NCT01881776|Other Pre-specified|Total Hours of Sleep|To compare the recovery profile of patients receiving CISB, SISB, or GA for arthroscopic rotator cuff repair surgery throughout the first postoperative week by using sleep duration.|first postoperative week (on day 7)|||hours||Standard Deviation|Mean
659381|NCT01881776|Other Pre-specified|Time to Discharge Home|To compare the recovery profile of patients receiving CISB, SISB, or GA for arthroscopic rotator cuff repair surgery throughout the first postoperative week by using time-to-discharge home.|throughout the first postoperative week (how long patients stayed in the hospital (includes PACU and hospital time)|||minutes||Standard Deviation|Mean
659382|NCT01881776|Other Pre-specified|Length of PACU Stay|To compare the recovery profile of patients receiving CISB, SISB, or GA for arthroscopic rotator cuff repair surgery throughout the first postoperative week by using length of PACU stay.|throughout the first postoperative week (how long patients stayed in PACU just after the operation)|||minutes||Standard Deviation|Mean
659383|NCT01881776|Other Pre-specified|Fast-tracked Postoperative Care Unit (PACU) Bypass Patient Number|To compare the recovery profile of patients receiving CISB, SISB, or GA for arthroscopic rotator cuff repair surgery throughout the first postoperative week by using fast-tracked PACU bypass rate|throughout the first postoperative week (how many patients left PACU immediately just after the operation)|||participants|||Number
659384|NCT01881776|Secondary|The Number of Patients Consume ≥1 Dose of Analgesics|The effects of the three anesthetic techniques (SISB, CISB, and GA) when used intraoperatively as a sole anesthesia modality were studied on postoperative pain (analgesic consumption).|throughout the first postoperative week|||participants|||Number
659385|NCT01881776|Secondary|Time-to-first Pain|The effects of the three anesthetic techniques (SISB, CISB, and GA) when used intraoperatively as a sole anesthesia modality were studied on postoperative pain (time-to-first pain).|throughout the first postoperative week|||hours||Standard Deviation|Mean
659386|NCT01881776|Primary|Patients With Pain: Numerical Rating Scale (NRS-11(0-10): 0:no Pain and 10:Severe/Worst Pain) ≥ 4|The effects of the three anesthetic techniques (continuous interscalene brachial plexus block (CISB), single interscalene brachial plexus block (SISB), or general anesthesia (GA)) when used intraoperatively as a sole anesthesia modality were studied on postoperative pain (highest NRS pain rating)|throughout the first postoperative week on days 1, 2, 3, and 7|||participants|||Number
659387|NCT01881737|Secondary|Pregnenolone Level in Peripheral Blood as Measured at Baseline and After 12 Weeks||12 weeks|During the 12-week treatment period, two participants dropped out of the study. The follow-up observations for one of the participants who dropped out were included in the analyses.||ng/ml||Standard Deviation|Mean
659388|NCT01881737|Secondary|Repetitive Behavior Scale||12 weeks|Data were not collected for this Outcome Measure because the total score is not a very valid measure of receptive behaviors.|||||
659389|NCT01881737|Secondary|Vineland Adaptive Behavior Scale|Adaptive Behavior Composite Score (score range 20-160); higher scores mean more typical adaptive behaviors.|12 weeks|||score (range 20-160)||Standard Deviation|Mean
659390|NCT01881737|Secondary|Sensory Profile Questionnaire Total Score|scores on a scale (range: 38-190); lower scores mean more abnormal sensory problems.|12|During the 12-week treatment period, two participants dropped out of the study. The follow-up observations for one of the participants who dropped out were included in the analyses.||scores on a scale (range: 38-190)||Standard Deviation|Mean
659391|NCT01881737|Secondary|Social Responsiveness Scale (SRS) Total Score|SRS total score (total range 0-195); higher scores mean more abnormal social behaviors.|12 weeks|||SRS total score (total range 0-195)||Standard Deviation|Mean
659392|NCT01881737|Primary|Number of Participants With Adverse Events According to Dosage Record and Treatment Emergent Symptom (DOTES) as Assessed at All Follow-up Visits (2, 4, 6, 8, 10, 12, and 16 Weeks)||2, 4, 6, 8, 10, 12, and 16 weeks|During the 12-week treatment period, two participants dropped out of the study. The follow-up observations for the two participants who dropped out were included in the analyses.||participants|||Number
659393|NCT01881126|Primary|Intraocular Pressure (IOP) in the Study Eye at 8 AM, 12 PM, and 4 PM|IOP is a measurement of the fluid pressure inside the eye. IOP of the study eye (worse eye) is measured at 8 AM, 12 PM, and 4 PM. IOP is either the average of 2 measurements, or, if a third measurement is required, the average of 3 measurements.|Week 12 at 8 AM, 12 PM, and 4 PM|Intent-to-Treat: all subjects who were randomized to study medication||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
659394|NCT01881087|Secondary|Failed Spinal Block Rate|Failed Spinal Block Rate for each treatment group|15 minutes after dose|||Participants|||Count of Participants
659395|NCT01881087|Primary|Probability of Motor Block|Likelihood Rate of motor block persistence after a dosis of spinal HLBP 0.75%|200 minutes|||percentage of motor block|||Number
659396|NCT01880840|Primary|Safety|"The objective of this clinical trial is to evaluate the safety of Astepro 0.15% Nasal Spray and Astepro 0.1% Nasal Spray at a dosage of 1 spray per nostril twice daily in subjects ≥6months to <6 years of age with allergic rhinitis.
Safety will be assessed on the basis of reported adverse experiences, nasal examinations, laboratory evaluations, and vital signs assessments.
Data for each age strata will be summarized separately as well as combined."|one month of treatment|||adverse events|||Number
659408|NCT01880723|Secondary|Diffusion Capacity of the Lungs for Nitric Oxide|Using the rebreathe technique the diffusion capacity of the lungs for carbon monoxide and nitric oxide were measured, and this allowed for the determination of alveolar-capillary membrane conductance and pulmonary capillary blood volume. These measurements were made at baseline and 30-, 60- and 90-minutes post albuterol administration in cystic fibrosis and healthy subjects.|baseline, 30-, 60- and 90-minutes post albuterol administration|||mL/min/mmHg||Standard Deviation|Mean
659397|NCT01880736|Secondary|Number of Treatment Emergent Nocturnal (00:01-05:59 am) Confirmed Hypoglycaemic Episodes in the Maintenance Period|The number of treatment emergent nocturnal (00:01-05:59 am) confirmed hypoglycaemic episodes in the maintenance period from 16 weeks to end of trial (week 27) was recorded by dosing regimen (flexible vs. fixed dosing); and by titration algorithm (simple vs stepwise). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes with a confirmed plasma glucose value of less than 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.|From week 16 to end of trial (week 27)|The SAS included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation “as treated”.||episodes|||Number
659398|NCT01880736|Secondary|Number of Treatment Emergent Nocturnal (00:01-05:59 am) Confirmed Hypoglycaemic Episodes|The number of treatment emergent nocturnal (00:01-05:59 am) confirmed hypoglycaemic episodes over the time period of Week 0-26 was recorded by dosing regimen (flexible vs. fixed dosing) and by titration algorithm (simple vs stepwise). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes with a confirmed plasma glucose value of less than 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.|Weeks 0-26|The SAS included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation “as treated”.||episodes|||Number
659399|NCT01880736|Secondary|Number of Treatment Emergent Confirmed Hypoglycaemic Episodes in the Maintenance Period|The number of treatment mergent confirmed hypoglycaemic episodes in the maintenance period from Week 16 to end of trial (week 27) was recorded by dosing regimen (flexible vs. fixed dosing) and by titration algorithm (simple vs. stepwise). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes with a confirmed plasma glucose value of less than 3.1 mmol/L.|From Week 16 to end of trial (week 27)|The safety analysis set (SAS) included all subjects who received at least one dose of the investigational product. Subjects were grouped either according to dosing pattern or treatment algorithm received. 451 subjects contributed to the analysis. Subjects in the safety analysis set contributed to the evaluation “as treated”.||episodes|||Number
659400|NCT01880736|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) Definition|Number of treatment emergent hypoglycaemic episodes according to the ADA definition (classified as severe hypoglycaemia, documented hypoglycaemia, asymptomatic hypoglycaemia, probable symptomatic hypoglycaemia, relative hypoglycaemia) over the time period of Week 0-26 was recorded by dosing regimen (flexible vs. fixed dosing) and by titration algorithm (simple vs stepwise).|Weeks 0-26|The SAS included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation “as treated”.||episodes|||Number
659401|NCT01880736|Secondary|Number of Treatment Emergent Confirmed Hypoglycaemic Episodes (Defined as Severe Hypoglycaemia and/or a Measured Plasma Glucose (PG) Less Than 3.1 mmol/L (Less Than 56 mg/dL))|The confirmed hypoglycaemic episodes (defined as severe hypoglycaemia and/or a measured plasma glucose (PG) less than 3.1 mmol/L [less than 56 mg/dL]) over the time period of Week 0-26 was recorded by dosing regimen (flexible vs. fixed dosing); and by titration algorithm (simple vs stepwise).|Weeks 0-26|The safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation “as treated”.||episodes|||Number
659402|NCT01880736|Secondary|Incidence of Treatment Emergent Adverse Events (TEAEs)|The incidences of treatment emergent adverse events (TEAEs) over the time period of Week 0-26 were recorded by dosing regimen (flexible vs. fixed dosing); and by titration algorithm (simple vs stepwise).|Weeks 0-26|The SAS included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation “as treated”.||events|||Number
659403|NCT01880736|Secondary|Responder for HbA1c (%) Based on Central Laboratory Assessment: HbA1c Below 7.0% at End of Trial|The number of subjects who achieved the pre-defined HbA1c target (<7.0%) after 26 weeks of treatment was recorded by dosing regimen (flexible vs. fixed dosing) and by titration algorithm (simple vs stepwise).|After 26 weeks of treatment|The FAS included all randomised subjects. 458 subjects were grouped according to dosing pattern or treatment algorithm received. Analysis was per intention to treat principle. Missing values were imputed using the Last Observation Carried Forward (LOCF) method.||Subjects|||Number
659404|NCT01880736|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|Changes from baseline in FPG values over the time period of Week 0-26 were evaluated by dosing regimen (flexible vs. fixed dosing) and by titration algorithm (simple vs stepwise).|Week 0, week 26|The FAS included all randomised subjects. 458 subjects were grouped according to dosing pattern or treatment algorithm received. Analysis was per intention to treat principle. Missing values were imputed using the Last Observation Carried Forward (LOCF) method.||mg/dL||Standard Deviation|Mean
659405|NCT01880736|Primary|Change From Baseline in HbA1c (%) Glycosylated Haemoglobin)|Changes from baseline in HbA1c values over time period of Week 0-26 were evaluated by dosing regimen (flexible vs. fixed dosing) and by titration algorithm (simple vs stepwise)|Week 0, week 26|The full analysis set (FAS) included all randomised subjects. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Analysis was per intention to treat principle. Missing values were imputed using the Last Observation Carried Forward (LOCF) method.||Percent (%) glycosylated haemoglobin||Standard Deviation|Mean
659406|NCT01880723|Secondary|Peripheral Oxygen Saturation|A finger pulse oximeter allowed for the measurement of peripheral oxygen saturation at baseline, 30-, 60- and 90-minutes post albuterol in cystic fibrosis and healthy subjects.|baseline, 30-, 60- and 90-minutes post albuterol|||percent of oxygenated hemoglobin||Standard Deviation|Mean
659410|NCT01880723|Primary|Exhaled Sodium (mmol/L)|We collected exhaled breath condensate (EBC) samples, with subjects breathing on a Jaeger EcoScreen for 20 minutes. EBC samples were collected in cystic fibrosis and healthy subjects before and 30-, 60-, and 90-minutes following albuterol administration.|up to 90-minutes post albuterol|||mmol/L||Standard Deviation|Mean
659411|NCT01880697|Primary|Number of Subjects Reporting Unsolicited Adverse Events After Receiving One Dose of TIVc|The number of subjects in both age groups reporting any unsolicited AEs (between Day 1 to 4), serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal (throughout the study period), after receiving one dose of TIVc is reported.|Day 1 through Day 22 post-vaccination|Analysis was done on the unsolicited safety set population i.e all subjects who have post-vaccination AE or reactogenicity records.||Subjects|||Number
659412|NCT01880697|Primary|Number of Subjects Reporting Solicited Adverse Events After Receiving One Dose of TIVc|The number of adult and elderly subjects reporting solicited local and systemic adverse events and other solicited adverse events after receiving one dose of TIVc are reported.|Day 1 to Day 4 post-vaccination|Analysis was done on the solicited safety set population i.e all subjects who have post-vaccination AE or reactogenicity records.||Subjects|||Number
659413|NCT01880697|Primary|Geometric Mean Ratio of Post Vaccination Versus Pre Vaccination HI Antibody Titers, Against Each of Three Vaccine Strains After Receiving One Dose of TIVc|"The antibody responses following one dose of TIVc were evaluated in terms of GMRs of post vaccination against pre vaccination geometric mean HI titers against each of the three vaccine strains, three weeks after receiving one dose of TIVc.
The related European (CHMP) criterion for the assessment of immunogenicity is met if the GMR day 22/day 1 is >2.5 for adults aged 18 to ≤60 years and > 2.0 for subjects aged ≥61 years."|Day 22/day 1|Analysis was done on the per-protocol population.||Ratio||95% Confidence Interval|Geometric Mean
659414|NCT01880697|Primary|Percentages of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After Receiving One Dose of TIVc|"Immunogenicity was assessed in terms of percentages of subjects in both age groups achieving seroconversion or significant increase in HI antibody titers after receiving one dose of TIVc.
Seroconversion is defined as percentage of subjects with a pre-vaccination HI titer <10 to a post-vaccination titer ≥40. Significant increase is defined as percentage of subjects with a pre-vaccination HI titer >10 to at least a 4-fold increase in post-vaccination HI antibody titers.
The related European (CHMP) criterion for the assessment of immunogenicity is met if >40 % for adults aged 18 to ≤60 years and >30% for subjects aged ≥61 years achieve seroconversion or significant increase in post-vaccination HI titers."|Day 22 (vaccination is on day 1)|Analysis was done on the per-protocol population.||Percentages of Subjects||95% Confidence Interval|Number
659415|NCT01880697|Primary|Percentage of Subjects With Haemagglutination Inhibition (HI) Titers ≥40, Against Each of Three Vaccine Strains After Receiving One Dose of TIVc|"Immunogenicity was assessed in terms of percentages of subjects in both age groups with HI titers ≥40, against each of the three vaccine strains, three weeks after receiving one dose of TIVc.
The related European (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving HI titers ≥ 40 is >70% for adults aged 18 to ≤60 years and >60% for subjects aged ≥61 years."|Day 22 (vaccination is on day 1)|Analysis was done on the per-protocol population.||Percentages of Subjects||95% Confidence Interval|Number
659416|NCT01880697|Primary|Geometric Mean Ratio of Post Vaccination Versus Pre Vaccination Geometric Mean Areas (GMAs), After One Dose of TIVc|The antibody responses were evaluated in terms of GMRs of post vaccination GMAs to pre vaccination GMAs against each of the three vaccine strains, three weeks after receiving one dose of TIVc The related European (CHMP) criterion for the assessment of immunogenicity is met if the GMR day 22/day 1 is >2.5 for adults aged 18 to ≤60 years and > 2.0 in for subjects aged ≥61 years.|Day 22/day 1|Analysis was done on the per-protocol population.||Ratio||95% Confidence Interval|Geometric Mean
659417|NCT01880697|Primary|Percentages of Subjects With Seroconversion or Significant Increase in SRH Area, Against Each of Three Vaccine Strains After Receiving One Dose of TIVc|"Immunogenicity was assessed in terms of percentages of subjects in both age groups achieving seroconversion or significant increase by SRH area against each of the three vaccine strains ,three weeks after receiving one dose of TIVc.
Seroconversion is defined as percentage of subjects with a pre-vaccination SRH area ≤4mm2 achieving a post-vaccination SRH area ≥25 mm2. Significant increase is defined as percentage of subjects with a pre-vaccination SRH area >4mm2 achieving at least 50% increase in post-vaccination SRH area.
The related European (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving post vaccination SRH areas ≥ 25mm2 is >40% for adults aged 18 to ≤60 years and >30% for subjects aged ≥61 years."|Day 22 (vaccination is on day 1)|Analysis was done on the per-protocol population.||Percentages of Subjects||95% Confidence Interval|Number
659418|NCT01880697|Primary|Percentage of Subjects With Single Radial Hemolysis (SRH) Areas ≥25mm2, Against Each of Three Vaccine Strains After Receiving One Dose of TIVc|"Immunogenicity was assessed in terms of percentages of subjects in both age groups with SRH areas ≥25mm2 against each of the three vaccine strains, three weeks after receiving one dose of TIVc.
The related European (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving post vaccination SRH areas ≥ 25mm2 is >70% for adults aged 18 to ≤60 years and >60% for subjects aged ≥61 years."|Day 22 (vaccination is on day 1)|Analysis was done on the per-protocol population i.e all subjects who have received study vaccination and provided immunogenicity data both at baseline and after vaccination; did not withdraw informed consent and did not have RT-PCR confirmed influenza during the study.||Percentages of Subjects||95% Confidence Interval|Number
659419|NCT01880515|Secondary|Progression Free Survival|From the start of consumption of BIBW 2992 to the date progression or last follow up|Participants will be followed for the duration of the treatment, an average of 8 weeks.|We estimated the progression free survival with the Kaplan Meier method, and comparisons among groups were performed with the log-rank test.||months||95% Confidence Interval|Median
659420|NCT01880515|Secondary|Progression Free-survival|The measure will be from the start of consumption to the first documented evidence of progression according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, or if patients still survive the measure will be made after 24 weeks|24 weeks from baseline||09/2017||||
659421|NCT01880515|Secondary|Quality of Life (QL)|A QL questionnaire from European Organization for Research and Treatment of Cancer (EORTC) organization (spanish version) will be performed at initiation of BIBW 2992 and then every month of follow-up until progression|from baseline to 6 months||||||
659443|NCT01880086|Secondary|Men's Sexual Health Questionnaire (MSHQ) Questionnaire|Overall, study subjects will be assessed for possible change in hypogonadal, sexual function, and pain symptoms. Minimum score is 1, maximum score is 20. Minimum score is considered most symptomatic, maximum score is considered least symptomatic.|3 months post initial visit|||scores on a scale||Standard Deviation|Mean
659422|NCT01880515|Primary|Frequency of Participants Who Experienced Any Grade of Rash As Characterized By The Common Toxicity Criteria for Adverse Effects (CTCAE) V4.0|Sum of participants who experienced any grade rash according to the Common Toxicity Criteria for Adverse Effects (CTCAE) V4.0, from the initiation of BIBW2992 compared to week 8.|Percentage of adverse events at week 8|Forty five patients were assigned to receive reactive treatment; the other 45 received pre-emptive tetracycline.There were no differences among demographics, disease stage and dermatological baseline characteristics between treatment groups.||Percentage of Patients w/any grade rash|||Number
659423|NCT01880437|Secondary|Area Under the Concentration-time Curve (AUC) of Cytarabine|PK data was planned to be reported only if the results of Cohort 2 are available.|Predose, 0.25, 0.5, 1, 3, 6 hours post-dose on Days 1, 8 and 29|No participants were enrolled as the study was terminated prior to the initiation of Cohort 2.|||||
659424|NCT01880437|Secondary|Pharmacokinetics (PK): Steady-state Plasma Concentration of Vismodegib|PK data was planned to be reported only if the results of Cohort 2 are available.|Predose on Days 8, 29 and 57|As the study was terminated prior to Cohort 2 enrollment, PK analysis could not be performed, as planned.|||||
659425|NCT01880437|Secondary|Percentage of Participants With an Event of Death During the Study||Up to death or 30 days of last dose of study drug (maximum treatment duration = 225 days)|Efficacy analysis population.||percentage of participants|||Number
659426|NCT01880437|Secondary|Median Overall Survival (OS) Time|OS was defined as the time from start of study drug to death from any cause. OS was estimated using Kaplan-Meier analysis. Participants alive at the last date known to be alive were censored for the analysis.|Up to death or 30 days of last dose of study drug (maximum treatment duration = 225 days)|Efficacy analysis population.||months||95% Confidence Interval|Median
659427|NCT01880437|Secondary|Duration of Overall Response (DOR)|DOR is defined as the time from the first occurrence of a documented overall response to the time of relapse, as determined by the investigator using International Working Group (IWG) criteria (Participants not falling under any of the response criteria [CR or CRi or MLFS or PR] described under outcome measure 1 were considered as non-responders) or death from any cause during the study (defined as death within 30 days after the last dose of study drug).|Up to 30 days of last dose of study drug (maximum treatment duration = 225 days)|Efficacy population including participants who were considered as responders.||weeks||95% Confidence Interval|Median
659428|NCT01880437|Secondary|Percentage of Participants With CR, CRi, MLFS or PR at Anytime During Study Treatment|CR was defined as achieved if the neutrophils count >1000 cells/µL, platelets count >100000/µL, bone marrow blasts <5%, no Auer rods (clumps of azurophilic granular material that form elongated needles seen in the cytoplasm of leukemic blasts), no transfusion requirements and no signs of EMD. CRi was defined if either of the cell (neutrophil or platelet) lineage was not recovered (neutrophils > 1000 cells/µL or NA or platelets count >100000/µL or NA, bone marrow blasts <5% with no Auer rods and confirmed by flow cytometry with no signs of EMD. MLFS (neutrophil and platelet criteria were NA) was defined as bone marrow blasts <5% with no Auer rods and confirmed by flow cytometry with no signs of EMD. PR was defined as neutrophils count >1000 cells/µL, platelets count >100000/µL, and >50% decrease from baseline to a range of 5-25% of bone marrow blasts or blasts <5% with Auer rods. The 95% confidence intervals (CI) were constructed using Blyth-Still-Cassella method.|Up to 30 days of last dose of study drug (maximum treatment duration = 225 days)|Efficacy analysis population included all enrolled participants. Here “number of participants analyzed” included participants who were evaluable for tumor response at anytime during the study.||percentage of participants||95% Confidence Interval|Number
659429|NCT01880437|Primary|Percentage of Participants With a Complete Response (CR) or CR With Incomplete Blood Count Recovery (CRi) or Morphologic Leukemia Free State (MLFS) or Partial Response (PR) at Week 8|CR was defined as achieved if the neutrophils count was greater than (>) 1000 cells per microliter (µL), platelets count >100000/µL, bone marrow blasts percentage (%) less than (<) 5, no Auer rods (clumps of azurophilic granular material that form elongated needles seen in the cytoplasm of leukemic blasts), no transfusion requirements and no signs of extra medullary disease (EMD). CRi was defined if either of the cell (neutrophil or platelet) lineage was not recovered (neutrophils >1000 cells/µL or Not applicable [NA] or platelets count >100000/µL or NA), bone marrow blasts <5% with no Auer rods and confirmed by flow cytometry with no signs of EMD. MLFS (neutrophil and platelet criteria were NA) was defined as bone marrow blasts <5% with no Auer rods and confirmed by flow cytometry with no signs of EMD. PR was defined as neutrophils count >1000 cells/µL, platelets count >100000/µL, and >50% decrease from baseline to a range of 5-25% of bone marrow blasts or blasts <5% with Auer rods.|Week 8|As the primary efficacy time-point (Week 8) was not reached for all participants due to study termination based on interim data analysis, the analysis of this outcome measure could not be performed, as per planned analysis.|||||
659430|NCT01880424|Secondary|Change From Baseline in 12-week Abdominal Discomfort|"The change from baseline in 12-week abdominal discomfort (i.e., the average of the non-missing daily abdominal discomfort scores reported during the 12-week Treatment Period).
Abdominal discomfort (in the last 24 hours) was assessed daily by patients on an 11-point NRS where 0 represents no abdominal discomfort and 10 represents very severe abdominal discomfort."|Baseline and 12-week Treatment Period|Intent to Treat (ITT) Population (all 839 randomized patients); analysis includes patients with analysis values at both baseline and during the Treatment Period. An observed cases approach to missing post-baseline data was applied (i.e., no imputation for missing values).||Units on a Scale||Standard Error|Least Squares Mean
659431|NCT01880424|Secondary|Change From Baseline in 12-week Abdominal Pain|"The change from baseline in 12-week abdominal pain (i.e., the average of the non-missing daily abdominal pain scores reported during the 12-week Treatment Period).
Abdominal pain at its worst (in the last 24 hours) was assessed daily by patients on an 11-point NRS where 0 represents no abdominal pain and 10 represents very severe abdominal pain."|Baseline and 12-week Treatment Period|Intent to Treat (ITT) Population (all 839 randomized patients); analysis includes patients with analysis values at both baseline and during the Treatment Period. An observed cases approach to missing post-baseline data was applied (i.e., no imputation for missing values).||Units on a Scale||Standard Error|Least Squares Mean
659444|NCT01880086|Secondary|Sexual Health Inventory for Men (SHIM) Questionnaire|Overall, study subjects will be assessed for possible change in hypogonadal, sexual function, and pain symptoms. Minimum score is 1, maximum score is 25. The minimum value is most symptomatic and maximum value is least symptomatic.|3 months post initial visit|||scores on a scale||Standard Deviation|Mean
659445|NCT01880086|Secondary|Estradiol||3 months post initial visit|||pg/mL||Standard Deviation|Mean
659432|NCT01880424|Secondary|Change From Baseline in 12-week Abdominal Bloating|"The change from baseline in 12-week abdominal bloating (i.e., the average of the non-missing daily abdominal bloating scores reported during the 12-week Treatment Period).
Abdominal bloating (in the last 24 hours) was assessed daily by patients on an 11-point NRS where 0 represents no abdominal bloating and 10 represents very severe abdominal bloating."|Baseline and 12-week Treatment Period|Intent to Treat (ITT) Population (all 839 randomized patients); analysis includes patients with analysis values at both baseline and during the Treatment Period. An observed cases approach to missing post-baseline data was applied (i.e., no imputation for missing values).||Units on a Scale||Standard Error|Least Squares Mean
659433|NCT01880424|Secondary|Change From Baseline in 12-week Severity of Straining|"The change from baseline in 12-week severity of straining (i.e., the average of the non-missing straining scores from the SBMs occurring during the 12-week Treatment Period).
Severity of straining was assessed daily by patients on a 5-point ordinal scale (1=Not at all to 5=An extreme amount)."|Baseline and 12-week Treatment Period|Intent to Treat (ITT) Population (all 839 randomized patients); analysis includes patients with analysis values at both baseline and during the Treatment Period. An observed cases approach to missing post-baseline data was applied (i.e., no imputation for missing values).||Units on a Scale||Standard Error|Least Squares Mean
659434|NCT01880424|Secondary|Change From Baseline in 12-week Stool Consistency|"The change from baseline in 12-week stool consistency (i.e., the average of the non-missing Bristol Stool Form Scale [BSFS] score from the SBMs occurring during the 12-week Treatment Period).
Consistency of each bowel movement was assessed daily by patients using the 7-point BSFS (1=Separate hard lumps like nuts [difficult to pass] to 7=Watery, no solid pieces [entirely liquid])."|Baseline and 12-week Treatment Period|Intent to Treat (ITT) Population (all 839 randomized patients); analysis includes patients with analysis values at both baseline and during the Treatment Period. An observed cases approach to missing post-baseline data was applied (i.e., no imputation for missing values).||Units on a Scale (BSFS)||Standard Error|Least Squares Mean
659435|NCT01880424|Secondary|Change From Baseline in 12-week Spontaneous Bowel Movement Frequency Rate|"The change from baseline in 12-week SBM frequency (i.e., average weekly SBM frequency over the 12 weeks of the Treatment Period).
SBM is defined as a bowel movement without laxative use in the preceding 24 hours."|Baseline and 12-week Treatment Period|Intent to Treat (ITT) Population (all 839 randomized patients); analysis includes patients with analysis values at both baseline and during the Treatment Period. An observed cases approach to missing post-baseline data was applied (i.e., no imputation for missing values).||SBMs per Week||Standard Error|Least Squares Mean
659436|NCT01880424|Secondary|Change From Baseline in 12-week Complete Spontaneous Bowel Movement Frequency Rate|"The change from baseline in 12-week CSBM frequency (i.e., average weekly CSBM frequency over the 12 weeks of the Treatment Period).
A spontaneous bowel movement (SBM) is defined as a bowel movement without laxative use in the preceding 24 hours. A CSBM is defined as an SBM that is associated with a sense of complete evacuation."|Baseline and 12-week Treatment Period|Intent to Treat (ITT) Population (all 839 randomized patients); analysis includes patients with analysis values at both baseline and during the Treatment Period. An observed cases approach to missing post-baseline data was applied (i.e., no imputation for missing values).||CSBMs per Week||Standard Error|Least Squares Mean
659437|NCT01880424|Primary|12-week Irritable Bowel Syndrome (IBS) Degree of Relief Responder|"A 12-week IBS Degree of Relief Responder is a patient who meets the IBS Degree of Relief Weekly Responder criteria (i.e., response to the degree of relief of IBS symptoms question for that week was “Considerably relieved” or “Completely relieved”) for at least 6 out of the 12 weeks of the Treatment Period.
Degree of relief of IBS symptoms (in the last 7 days) was assessed weekly by patients on a 7-point balanced ordinal scale where 1 = Completely relieved, 4 = Unchanged, and 7 = As bad as I can imagine."|Baseline and Weeks 1-12 during the Treatment Period|Intent to Treat (ITT) Population (all 839 randomized patients). If a patient did not have an IBS degree of relief score for a particular Treatment Period week, the patient was not considered a responder for that week.||Participants|||Number
659438|NCT01880424|Primary|12-week Abdominal Pain/Abdominal Discomfort Weekly Responder|"A 12-week Abdominal Pain/Abdominal Discomfort Responder is a patient who meets the Abdominal Pain/Abdominal Discomfort Weekly Responder criteria (i.e., an improvement of ≥30% from baseline in either the mean abdominal pain score or mean abdominal discomfort score for that week, with neither score worsening from baseline for that week) for at least 6 out of the 12 weeks of the Treatment Period.
Abdominal pain at its worst (in the last 24 hours) was assessed daily by patients on an 11-point numerical rating scale (NRS) where 0 represents no abdominal pain and 10 represents very severe abdominal pain.
Abdominal discomfort (in the last 24 hours) was assessed daily by patients on an 11-point NRS where 0 represents no abdominal discomfort and 10 represents very severe abdominal discomfort."|Baseline and Weeks 1-12 during the Treatment Period|Intent to Treat (ITT) Population (all 839 randomized patients). If a patient did not have an abdominal pain score or abdominal discomfort score for a particular Treatment Period week, the patient was not considered a responder for that week.||Participants|||Number
659439|NCT01880320|Primary|Changes From Baseline in Non-Inflammatory Lesion Counts||Baseline - Week 12|ITT Population, Multiple Imputation||lesions||Standard Error|Least Squares Mean
659440|NCT01880320|Primary|Changes From Baseline in Inflammatory Lesion Counts||Baseline - Week12|ITT Population, Multiple imputation||Lesions||Standard Error|Least Squares Mean
659441|NCT01880320|Primary|Success Rate|"Success was defined as 'Clear' or 'Almost Clear' on the Investigator Global Assessment (IGA).
Success rate at Week 12 was estimated using multiple imputation approach which is an average of response from multiple imputed datasets."|Week 12|Intent-to-treat (ITT): All subjects who were randomized. Baseline IGA Severe population: All randomized subjects who had IGA=4 at baseline.||percentage of participants|||Number
659442|NCT01880099|Primary|Smoking Choice Procedure|After overnight abstinence, participants will receive 10 tokens at the beginning of the smoking choice session. These tokens can be exchanged for money (0.75$ / token) or 2 cigarette puffs. The session starts with sample smoking of 2 puffs that allows subjective responses to me measured after abstinence. 15 min later, participants make their first choice, followed by 9 additional choices, every 15 minutes.|Data was acquired during a single test session during week 3 of drug intervention.|The number of participants analyzed per arm for this outcome is different than participant flow data because not every participant completed the smoking choice session.||# of choices to smoke (out of 10)||Standard Deviation|Mean
659446|NCT01880086|Secondary|Hematocrit (%)|Measure hematocrit from baseline.|3 months post initial visit|||percentage||Standard Deviation|Mean
659450|NCT01879852|Secondary|Change in Urinary Concentrations of C-terminal Crosslinking Telopeptide of Type II Collagen (CTX-II)|CTX-II is a biomarker of Type II collagen degradation. Early-morning, second void, fasting urine samples will be collected and stored. Concentrations of CTX-II will be determined with enzyme-linked immunosorbent assay, corrected for creatine concentration, and log-transformed. Creatinine concentration will also be determined with enzyme-linked immunosorbent assay.|Baseline (pre-surgery) to 7 weeks post-surgery (post-intervention)|2 subjects in the Standard Rehabilitation group did not complete the intervention or post-treatment testing.||log (ng/mmol)||Standard Deviation|Mean
659451|NCT01879852|Secondary|Single Leg Forward Hop Index|Three trials of the single leg forward hop will be collected on each side. Distance will be averaged across trials. The single leg hop index will be computed as [(distance on the surgical side/distance on the non-surgical side) *100]|7 weeks post-surgery (post-intervention)|2 subjects in the Standard Rehabilitation group did not complete the intervention or post-treatment testing. 2 subjects in the Standard Rehabilitation group and 1 subject in the Standard + Quadriceps Intensive Strengthening group did not complete hop testing.||percentage||Standard Deviation|Mean
659452|NCT01879852|Primary|Change in Tibial Articular Cartilage Volume|A magnetic resonance image (MRI) of the knee will be acquired and software will be used to quantify tibial articular cartilage volume.|Baseline (pre-surgery) to 1 year post-surgery|2 subjects in the Standard Rehabilitation group did not complete the intervention or post-treatment testing. Images were not analyzable for one subject in the Standard+Quadriceps Intensive Strengthening group.||percentage change from baseline||Standard Deviation|Mean
659453|NCT01879852|Primary|Change in International Knee Documentation Committee (IKDC) Subjective Knee Form Score|The IKDC is a measure of self-reported knee function and includes items related to symptoms and functional activity. Responses on the IKDC subjective knee form will be recorded on hard-copy and the summary score computed. The highest (best) possible score is 100 points and the lowest (worst) possible score is 0 points.|Baseline (pre-surgery) to 7 weeks post-surgery (post-intervention)|2 subjects in the Standard Rehabilitation group did not complete the intervention or post-treatment testing.||units on a scale||Standard Deviation|Mean
659454|NCT01879800|Secondary|Mean Change in Hamilton Anxiety Rating Scale (HAM-A) From Baseline to 3 and 6 Month Follow-up|"The Hamilton Anxiety Rating Scale (HAM-A) is a psychological questionnaire used by clinicians to rate the severity of a patient's anxiety.
Each item is scored independently based on a five-point, ratio scale. Upon the completion of the evaluation, the clinician compiles a total, composite score based upon the summation of each of the 14 individually rated items. This calculation will yield a comprehensive score in the range of 0 to 56. It has been predetermined that the results of the evaluation can be interpreted as follows. A score of 17 or less indicates mild anxiety severity. A score from 18 to 24 indicates mild to moderate anxiety severity. A score of 25 to 30 indicates a moderate to severe anxiety severity. Lastly, a score above 30 represents severe anxiety severity. The mean change in ratings will be assessed from baseline to 3 and 6 months follow up."|3- and 6- Month Follow-Up|||units on a scale||Standard Error|Mean
659455|NCT01879800|Secondary|Mean Change in Hamilton Depression Rating Scale (HAM-D) From Baseline to 3 and 6 Month Follow-up|"The HAM-D is a structured clinical interview for assessing depression severity. Outcome measure will be change from Baseline in Hamilton Depression Rating Scale and at 3 and 6 month follow-ups.
Measure is scored by adding individual items and attaining an overall severity score. Scores range from 0 to 53, with higher values signifying a higher level of depression severity (and thus a worse outcome). A score of 0–7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher (indicating at least moderate severity) is usually required for entry into a clinical trial."|3-month and 6-Month Follow-Up|||units on a scale||Standard Deviation|Mean
659456|NCT01879800|Primary|Mean Change in Participants World Health Organization Quality of Life Measure- Physical Score: Change From Baseline to 3 and 6 Month Follow-up.|"The World Health Organization Quality of Life Measure- Physical scale assesses quality of life in physical health- specifically in activities of daily living, Dependence on medicinal substances and medical aids, Energy and fatigue, Mobility, Pain and discomfort, Sleep and rest, and Work Capacity. Outcome measure will be the change from baseline, at 3, and 6 months.
Each item ranges in score from 1-5. Individual items are rated on a 5 point Likert scale where 1 indicates low, negative perceptions and 5 indicates high, positive perceptions. As such, domain and facet scores are scaled in a positive direction where higher scores denote higher quality of life.
The mean score of the items within this physical domain is used to calculate the overall physical domain score. Mean scores are then multiplied by 4, yielding a score of 4 to 20. A higher domain score indicates a higher quality of life in physical ability."|Change at 3 and 6- Month Follow-up|||units on a scale||Standard Error|Mean
659457|NCT01879735|Primary|Percentage of Participants in Whom we Could Quantify Hepatic Transport of 11C-CSar||All measurements are performed in one day.|||percentage of participants|||Number
659458|NCT01879722|Secondary|CLr: Renal Clearance of TAK-063 and TAK-063 Metabolite M-I|CLr is a measure of apparent clearance of the drug from the urine calculated as total amount excreted in the urine from time 0 to 24 hours postdose / plasma area under the curve from time 0 to 24 hours post-dose.|Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours)|PK Set included all randomized participants who received study drug for whom PK data was available for analysis.||mL/hour||Standard Deviation|Mean
659459|NCT01879722|Secondary|Fe: Fraction of Drug Excreted in Urine for TAK-063|Fe is a measure of the fraction of drug excreted in urine and is calculated as Fe = (total amount excreted in the urine from time 0 to 24 hours post-dose / dose)×100|Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours)|PK Set included all randomized participants who received study drug for whom PK data was available for analysis.||percent||Standard Deviation|Mean
659460|NCT01879722|Secondary|Ae(0-24): Total Amount Excreted in the Urine From Time 0 to 24 Hours Postdose for TAK-063 and TAK-063 Metabolite M-I|Ae(0-24) is a measure of the total amount of study drug excreted in the urine from time 0 to 24 hours postdose.|Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours)|PK Set included all randomized participants who received study drug for whom PK data was available for analysis.||ng||Standard Deviation|Mean
659486|NCT01879579|Other Pre-specified|Percentage of Successful Phone Calls|The number of successful insulin titration phone calls compared to the total number of insulin titration phone calls assigned to the nurse. Successful phone calls are defined as when the nurse was able to reach the participant with one call attempt, two call attempts, or by voicemail. This outcome is given as a percent.|12 weeks|Participants who completed the allocated intervention.||percentage of phone calls|Participants||Number
659461|NCT01879722|Secondary|Accumulation Ratios Between Day 7 AUC(0-24) and Day 1 AUC(0-24)|Accumulation ratios between Day 7 AUC(0-24) and Day 1 AUC(0-24), (Day 7/Day 1). Estimated Ratio (Day 7/Day 1) is the exponentiated results of the difference between Day 7 and Day 1 in log-transformed values which resolves to the ratio of Day 7/Day 1 estimates.|Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours)|PK Set included all randomized participants who received study drug for whom PK data was available for analysis.||ratio||90% Confidence Interval|Mean
659462|NCT01879722|Secondary|AUC(0-24) Ratio: Ratio of TAK-063 Metabolite AUC(0-24) to TAK-063 AUC(0-24)|AUC(0-24) Ratio is the ratio of AUC(0-24) values of the metabolite compared to the parent calculated by dividing AUC(0-24) values of metabolite M-I with those of the parent drug TAK-063.|Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours)|PK Set included all randomized participants who received study drug for whom PK data was available for analysis.||ratio||Standard Deviation|Mean
659463|NCT01879722|Secondary|Cmax Molar Ratio: Ratio of TAK-063 Metabolite Cmax to TAK-063 Cmax|Cmax Molar Ratio is the ratio of Cmax molar values of the metabolite compared to the parent calculated by dividing Cmax molar values of metabolite M-I with those of TAK-063.|Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours)|PK Set included all randomized participants who received study drug for whom PK data was available for analysis.||ratio||Standard Deviation|Mean
659464|NCT01879722|Secondary|Average Plasma Concentration on Day 1 (Cav) and Day 7 (Cavss) for TAK-063 and TAK-063 Metabolite M-I|Cav is the Average plasma concentration on Day 1, calculated as AUC(0-24)/24 on Day 1. Cavss is the average plasma concentration on Day 7, calculated as AUC(0-24)/24 on Day 7.|Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours)|PK Set included all randomized participants for whom PK data was available for analysis.||ng/mL||Standard Deviation|Mean
659465|NCT01879722|Secondary|CL/F: Oral Clearance of TAK-063|CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided by area under the curve from time 0 to 24 hours post-dose, after multiple dosing (at steady state).|Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours)|PK Set included all randomized participants who received study drug for whom PK data was available for analysis.||liter/hour||Standard Deviation|Mean
659466|NCT01879722|Secondary|AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Postdose for TAK-063 and TAK-063 Metabolite M-I|AUC(0-24) is a measure of total plasma exposure to the drug from Time 0 to 24 hours post-dose.|Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours)|PK Set included all randomized participants who received study drug for whom PK data was available for analysis.||ng*hr/mL||Standard Deviation|Mean
659467|NCT01879722|Secondary|AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-063 and TAK-063 Metabolite M-I|AUC(0-tlqc) is a measure of total plasma exposure to the drug from time 0 to time of the Last Quantifiable Concentration.|Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours)|PK Set included all randomized participants who received study drug for whom PK data was available for analysis.||ng*hr/mL||Standard Deviation|Mean
659468|NCT01879722|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-063 and TAK-063 Metabolite M-I|Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.|Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours)|PK Set included all randomized participants who received study drug for whom PK data was available for analysis.||hour||Full Range|Median
659469|NCT01879722|Secondary|Cmax: Maximum Observed Plasma Concentration for TAK-063 and TAK-063 Metabolite M-I|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours)|PK Set included all randomized participants who received study drug for whom PK data was available for analysis.||ng/mL||Standard Deviation|Mean
659470|NCT01879722|Primary|Percentage of Participants With Markedly Abnormal Values of 12-Lead Electrocardiogram (ECG) Parameters|The percentage of participants who meet markedly abnormal criteria specified by the protocol and statistical analysis plan during the treatment period.|Day 1 to Day 8|Safety population included all randomized participants who received at least one dose of study drug.||percentage of participants|||Number
659471|NCT01879722|Primary|Percentage of Participants With Markedly Abnormal Vital Sign Measurements|The percentage of participants who meet markedly abnormal criteria for vital signs, including oral body temperature, respiration rate, pulse, and resting blood pressure and after standing|Day 1 to Day 8|Safety population included all randomized participants who received at least one dose of study drug.||percentage of participants|||Number
659472|NCT01879722|Primary|Percentage of Participants With Markedly Abnormal Safety Laboratory Tests|The percentage of participants with any markedly abnormal standard safety laboratory values, including hematology, serum chemistries, and urinalysis, during the treatment period.|Day 1 to Day 8|Safety population included all randomized participants who received at least one dose of study drug.||percentage of participants|||Number
659473|NCT01879722|Primary|Percentage of Participants Who Experience at Least One Treatment-Emergent Adverse Event (TEAE) After 7 Days of Dosing|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|Day 1 to Day 14|Safety population included all randomized participants who received at least one dose of study drug.||percentage of participants|||Number
659487|NCT01879579|Other Pre-specified|Percentage of Text Message Responses|The number of text message replies from participants compared to the total number of text messages sent to participants (asking for blood glucose values). This outcome is given as a percent.|12 weeks|Participants who completed the allocated intervention.||percentage of text messages|Participants||Number
659488|NCT01879579|Secondary|Incidence of Hypoglycemia|The number of instances of hypoglycemia as indicated by fasting blood glucose levels or symptoms reported by patients in both study arms.|12 weeks|This outcome was analyzed for participants who completed the allocated intervention (and the participant who discontinued insulin early due to a mild possible allergy). Five participants reported hypoglycemia: 3 in the MITI arm and 2 in the CBP arm. All cases were mild.||instances of hypoglycemia|||Number
659474|NCT01879683|Primary|Percentage of Participants by Change From Baseline in Appearance of Hunner's Lesions at Day 28|The appearance of the Hunner’s lesions was assessed by the investigator using video capture of the bladder mucosa during the cystoscopic examinations. Complete responders (CR)=no lesions observed at day of last LiRIS removal; Partial responders (PR) = presence of residual lesions on day of last LiRIS removal however there is cystoscopic evidence of a decrease in either i) the affected area as calculated by size and dimension of individual lesions summed together or ii) the lesion number or iii) the lesion(s) severity (mild, moderate, severe) as compared with Baseline assessment; Stable Disease=no change in the appearance of lesions and no new lesions on day of last LiRIS removal compared with Baseline assessment; Non-responders=worsening of mucosal appearance on day of last LiRIS removal.|Baseline, Day 28|Per protocol population included all participants who retained each LiRIS for both 14-day treatment periods and then completed the 4-week follow-up visit without any major protocol deviations.||percentage of participants|||Number
659475|NCT01879683|Secondary|Change From Baseline in Patient Reported IC Symptom: Daily Total Voids|The number of day-time voidings and the number of night-time voidings were averaged over a period of 3 full days and nights. A negative change from Baseline indicates improvement|Baseline, during treatment (Days 7, 14, 20, 28) and during follow-up (Weeks 1, 2, 4, 8, 12)|Per protocol population included all participants who retained each LiRIS for both 14-day treatment periods and then completed the 4-week follow-up visit without any major protocol deviations. 2 participants did not have data at Week 8 and 12 Follow-up.||voids||Standard Deviation|Mean
659476|NCT01879683|Secondary|Change From Baseline in Patient Reported Interstitial Cystitis (IC) Symptom: Average Bladder Pain|Participants rated symptom bladder pain averaged over the previous 3 days using an 11-point numeric rating scale where: 0=no pain to 10=worst pain imaginable. A negative change from Baseline indicates improvement.|Baseline, during treatment (Days 7, 14, 20, 28) and during follow up (Weeks 1, 2, 4, 8, 12)|Per protocol population included all participants who retained each LiRIS for both 14-day treatment periods and then completed the 4-week follow-up visit without any major protocol deviations. 2 participants did not have data at Week 8 and 12 Follow-up.||score on a scale||Standard Deviation|Mean
659477|NCT01879683|Primary|Percentage of Participants by Change From Baseline in Appearance of Hunner's Lesions at Day 14|The appearance of the Hunner’s lesions was assessed by the investigator using video capture of the bladder mucosa during the cystoscopic examinations. Complete responders (CR)=no lesions observed at day of last LiRIS removal; Partial responders (PR)=presence of residual lesions on day of last LiRIS removal however there is cystoscopic evidence of a decrease in either: i) the affected area as calculated by size and dimension of individual lesions summed together or ii) the lesion number or iii) the lesion(s) severity (mild, moderate, severe) as compared with Baseline assessment; Stable Disease=no change in the appearance of lesions and no new lesions on day of last LiRIS removal compared with Baseline assessment; Non-responders=worsening of mucosal appearance on day of last LiRIS removal.|Baseline, Day 14|Per protocol population included all participants who retained each LiRIS for both 14-day treatment periods and then completed the 4-week follow-up visit without any major protocol deviations.||percentage of participants|||Number
659478|NCT01879618|Secondary|Mean Percent of HD Sessions With an Acceptable Dose|A HD session with an acceptable dose is defined in terms of efficacy of the drug: an HD session for which the dose at the next HD session did not need to be changed due to Grade 3 or 4 clotting, bleeding, access compression time > 10 minutes, or other clinical event. The point estimate and 95% CI were computed based on GEE model for clustered binomial.|20 HD sessions (up to 4 hours)|FAS was used for all efficacy analyses which included all participants who received at least one dose of study medication. For this endpoint, there were 2630 evaluable HD sessions from 148 participants.||Percentage of HD sessions||95% Confidence Interval|Mean
659479|NCT01879618|Primary|Mean Percent of Successful HD Sessions|A successful HD session is defined in terms of efficacy of the drug where the HD session had completed as planned: there was no premature termination due to Grade 3 or 4 clotting or saline flush to prevent the loss of the extracorporeal circuit due to clotting; it was not possible to return the participant’s blood or assess the exact extent of clotting. HD sessions which terminated prematurely due to Grade 1 or 2 clotting, safety event, machine failure, or access site displacement were excluded from the analysis. The point estimate and 95% CI were computed based on generalized estimating equation (GEE) model for clustered binomial data.|20 HD sessions (up to 4 hours)|The Full Analysis Set (FAS) was used for all efficacy analyses which included all participants who received at least one dose of study medication. There were 2776 HD sessions from 151 participants included in the primary analysis.||Percentage of HD Sessions||95% Confidence Interval|Mean
659480|NCT01879579|Other Pre-specified|Qualitative Patient Satisfaction Interview|The study staff will interview MITI arm patients, using free-response questions, to assess their satisfaction with the intervention. The interviews will take place in person or over the phone at the patient's convenience, after the patient has reached his/her optimal insulin dose. If the patient does not reach optimal insulin dose, the interview will take place at approximately 12 weeks.|After patient reaches optimal insulin dose or at 12 weeks||||||
659481|NCT01879579|Other Pre-specified|Costs - Co-pays|At baseline, participants in both study arms (MITI and CBP) reported whether they had to pay co-pays for clinic visits at Bellevue Hospital.|baseline|||participants|||Number
659482|NCT01879579|Other Pre-specified|Costs - Patient Travel Time|The time it took patients to travel to Bellevue Hospital, reported by patients in both study arms at baseline and at any subsequent clinic visits.|12 weeks|||minutes||Inter-Quartile Range|Median
659483|NCT01879579|Other Pre-specified|Costs - Titration Visit Information|The number of insulin titration visits (whether by phone or in the clinic).|12 weeks|Participants who completed the allocated intervention (and the participant who discontinued insulin early).||insulin titration visits||Inter-Quartile Range|Median
659484|NCT01879579|Other Pre-specified|Costs - Provider Time Spent on Insulin Titration Visits|Provider time spent on insulin titration visits by phone compared to insulin titration visits in the clinic.|12 weeks|Insulin titration visits with a duration recorded.||minutes|Participants|Inter-Quartile Range|Median
659485|NCT01879579|Other Pre-specified|Patient Healthcare Utilization|The number of medication refill, emergency department, and walk-in clinic visits at Bellevue Hospital (non-insulin titration visits).|12 weeks|All participants.||hospital visits|||Number
659489|NCT01879579|Secondary|Change in Treatment Satisfaction|The Diabetes Treatment Satisfaction Questionnaire change (DTSQc) will be used to measure the change in the patient's satisfaction with his/her diabetes treatment since initiation of long-acting insulin titration. Scores on questionnaire range from -3 to +3: -3 = much less satisfied now, +3 = much more satisfied now.|12 weeks (approximately 3 months)|All participants who completed the treatment satisfaction questionnaire at 12 weeks.||score on satisfaction scale||Standard Deviation|Mean
659490|NCT01879579|Secondary|Treatment Satisfaction After Initiation of Insulin Titration|The Diabetes Treatment Satisfaction Questionnaire standard (DTSQs) will be used to measure the patient's satisfaction with diabetes treatment received since initiation of long-acting insulin titration. Scores on questionnaire range from 0 to 6: 0 = very dissatisfied, 6 = very satisfied.|12 weeks (approximately 3 months)|All participants who completed the treatment satisfaction questionnaire at 12 weeks.||score on satisfaction scale||Standard Deviation|Mean
659491|NCT01879579|Secondary|Baseline Treatment Satisfaction|The Diabetes Treatment Satisfaction Questionnaire standard (DTSQs) will be used to measure the patient’s satisfaction with diabetes treatment received prior to study participation. Scores on questionnaire range from 0 to 6: 0 = very dissatisfied, 6 = very satisfied.|baseline|All participants who completed the treatment satisfaction questionnaire at baseline.||score on satisfaction scale||Standard Deviation|Mean
659492|NCT01879579|Secondary|Hemoglobin A1c|Change in hemoglobin A1c|baseline, 12 weeks (approximately 3 months)|All participants with hemoglobin A1c measurements recorded at baseline and 12 weeks.||mg/dL||Standard Deviation|Mean
659493|NCT01879579|Secondary|Time to Reach Optimal Long-acting Insulin Dose|The time it takes a patient to reach his/her optimal long-acting insulin dose will be measured for both study arms.|12 weeks|Participants who reached optimal long-acting insulin dose.||weeks||Inter-Quartile Range|Median
659494|NCT01879579|Primary|Percentage of Subjects Who Reach Optimal Long-acting Insulin Dose||12 weeks|No primary outcome data available for one participant in Current Best Practice arm who discontinued insulin early due to a mild possible allergy.||percentage of participants|||Number
659495|NCT01879553|Primary|Number of Subjects Reporting Unsolicited Adverse Events After Receiving One Dose of TIV|The number of subjects in both age groups reporting any unsolicited AEs (between Day 1 to 4), serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal (Day 1 to Day 22), after receiving one dose of TIV is reported.|Day 1 through Day 22 post vaccination|Analysis was done on the unsolicited safety set population i.e all subjects who have post vaccination unsolicited adverse event data||Number of subjects|||Number
659496|NCT01879553|Primary|Number of Subjects Reporting Solicited Adverse Events After Receiving One Dose of TIV|The number of adult and elderly subjects reporting solicited local and systemic adverse events and other solicited adverse events after receiving one dose of TIV are reported.|Day 1 to Day 4 post vaccination|||Number of subjects|||Number
659497|NCT01879553|Primary|Geometric Mean Ratio (GMR) of Post Vaccination Versus Pre Vaccination HI Antibody Titers, After Receiving One Dose of TIV|"The antibody responses following one dose of TIV were evaluated in terms of GMRs of post vaccination against pre vaccination geometric mean HI titers against each of the three vaccine strains, three weeks after receiving one dose of TIV.
The related European (CHMP) criterion for the assessment of immunogenicity is met if the GMR day 22/day 1 is >2.5 for adults aged 18 to ≤60 years and > 2.0 for subjects aged ≥61 years."|Day 22 (postvaccination)/ Day 1 (baseline)|Analysis was done on the per-protocol population||Ratio||95% Confidence Interval|Geometric Mean
659498|NCT01879553|Primary|Percentages of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After Receiving One Dose of TIV|"Immunogenicity was assessed in terms of percentages of subjects in both age groups achieving seroconversion or significant increase in HI antibody titers after receiving one dose of TIV.
Seroconversion is defined as percentage of subjects with a pre vaccination HI titer <10 to a post vaccination titer ≥40. Significant increase is defined as percentage of subjects with a pre vaccination HI titer ≥10 to at least a 4-fold increase in post vaccination HI antibody titers.
The related European (CHMP) criterion for the assessment of immunogenicity is met if >40% for adults aged 18 to ≤60 years and >30% for subjects aged ≥61 years achieve seroconversion or significant increase in post-vaccination HI titers."|Day 22 (postvaccination) / Day 1 (baseline)|Analysis was done on the per-protocol population||Percentages of subjects||95% Confidence Interval|Number
659499|NCT01879553|Primary|Percentages of Subjects With Haemagglutination Inhibition (HI) Titers ≥40, Against Each of Three Vaccine Strains After Receiving One Dose of TIV|"Immunogenicity was assessed in terms of percentages of subjects in both age groups with HI titers ≥40, against each of the three vaccine strains, three weeks after receiving one dose of TIV.
The related European (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving HI titers ≥ 40 is >70% for adults aged 18 to ≤60 years and >60% for subjects aged ≥61 years."|Day 1 (baseline) and Day 22 (postvaccination)|Analysis was done on the per-protocol population.||Percentages of subjects||95% Confidence Interval|Number
659500|NCT01879553|Primary|Geometric Mean Ratio (GMR) of Post Vaccination Versus Pre Vaccination Geometric Mean Areas (GMAs), After One Dose of TIV|"The antibody responses were evaluated in terms of GMRs of post vaccination GMAs to pre vaccination GMAs against each of the three vaccine strains, three weeks after receiving one dose of TIV.
The related European (CHMP) criterion for the assessment of immunogenicity is met if the GMR day 22/day 1 is >2.5 for adults aged 18 to ≤60 years and > 2.0 in for subjects aged ≥61 years."|Day 22 (postvaccination) / Day 1 (baseline)|Analysis was done on the per-protocol population||Ratio||95% Confidence Interval|Geometric Mean
659501|NCT01879553|Primary|Percentages of Subjects With Seroconversion or Significant Increase in SRH Area, Against Each of Three Vaccine Strains After Receiving One Dose of TIV|"Immunogenicity was assessed in terms of percentages of subjects in both age groups achieving seroconversion or significant increase by SRH area against each of the three vaccine strains, three weeks after receiving one dose of TIV.
Seroconversion is defined as percentage of subjects with a pre vaccination SRH area ≤4mm2 achieving a post vaccination SRH area ≥25 mm2. Significant increase is defined as percentage of subjects with a pre-vaccination SRH area >4mm2 achieving at least 50% increase in post vaccination SRH area.
The related European (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving post vaccination SRH areas ≥ 25mm2 is >40% for adults aged 18 to ≤60 years and >30% for subjects aged ≥61 years."|Day 22 (postvaccination) /Day 1 (baseline)|Analysis was done on the per-protocol population||Percentages of subjects||95% Confidence Interval|Number
659502|NCT01879553|Primary|Percentages of Subjects With Single Radial Hemolysis (SRH) Areas ≥25mm2, Against Each of Three Vaccine Strains After Receiving One Dose of TIV|"Immunogenicity was assessed in terms of percentages of subjects in both age groups with SRH areas ≥25mm2 against each of the three vaccine strains, three weeks after receiving one dose of TIV .
The related European Committee for Human Medicinal Products (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving post vaccination SRH areas ≥ 25mm2 is >70% for adults aged 18 to ≤60 years and >60% for subjects aged ≥61 years."|Day 1 (baseline) and Day 22 (postvaccination)|Analysis was done on the per-protocol population i.e all subjects who have received study vaccination and provided immunogenicity data both at baseline and after vaccination; did not withdraw informed consent and did not have RT-PCR confirmed influenza during the study||Percentage of subjects||95% Confidence Interval|Number
659503|NCT01879540|Primary|Number of Subjects Reporting Unsolicited Adverse Events After Receiving One Dose of aTIV|The number of adult subjects ≥65 years of age subjects reporting any unsolicited adverse event (AEs) between Day 1 to 4 and serious adverse events (SAEs), medically attended AEs, AEs leading to withdrawal from the study between Day 1 to Day 22 after receiving one dose of aTIV are reported.|Day 1 to Day 22 post-vaccination|Analysis was done on the unsolicited safety set population i.e all subjects who had post-vaccination unsolicited AE records||Participants|||Number
659504|NCT01879540|Primary|Number of Subjects Reporting Solicited Adverse Events After Receiving One Dose of aTIV|The number of adult subjects ≥65 years of age reporting solicited local and systemic adverse events and other solicited adverse events after receiving one dose of aTIV are reported.|Day 1 to Day 4 post vaccination|Analysis was done on the safety set population i.e all subjects who have post-vaccination AE or reactogenicity records||Participants|||Number
659505|NCT01879540|Primary|Geometric Mean Ratio (GMR) of Post Vaccination Versus Pre Vaccination HI Titers, Against Each of Three Vaccine Strains After Receiving One Dose of aTIV|"The antibody responses following one dose of aTIV were evaluated in terms of GMRs of post vaccination geometric mean HI titers against each of the three vaccine strains, three weeks after receiving one dose of aTIV.
The related European (CHMP) criterion for the assessment of immunogenicity is met if the GMR day 22/day 1 is > 2.0."|Day 22/Day 1|Analysis was done on the per-protocol population||Ratio||95% Confidence Interval|Geometric Mean
659506|NCT01879540|Primary|Percentages of Subjects With Seroconversion or Significant Increase in HI Antibody Titers, Against Each of Three Vaccine Strains After Receiving One Dose of aTIV|"Immunogenicity was assessed in terms of percentages of adult subjects ≥65 years of age achieving seroconversion or significant increase in HI antibody titers after receiving one dose of aTIV.
Seroconversion is defined as percentage of subjects with a pre-vaccination HI titer <10 to a post-vaccination titer ≥40. Significant increase is defined as percentage of subjects with a pre-vaccination HI titer ≥10 to at least a 4-fold increase in post-vaccination HI antibody titers.
The related European (CHMP) criterion for the assessment of immunogenicity is met if >30% of subjects achieve seroconversion or significant increase in post-vaccination HI titers."|Day 22|Analysis was done on the per-protocol population||Percentage of subjects||95% Confidence Interval|Number
659507|NCT01879540|Primary|Percentages of Subjects With Haemagglutinin Inhibition(HI) Titers ≥40, Against Each of Three Vaccine Strains After Receiving One Dose of aTIV.|"Immunogenicity was assessed in terms of percentages of adult subjects ≥65 years of age with HI titers ≥40, against each of the three vaccine strains, three weeks after receiving one dose of aTIV.
The related European (CHMP) criterion for the assessment of immunogenicity is met if the of subjects achieving HI titers ≥ 40 is >60%."|Day 1 (baseline) and Day 22|Analysis was done on the per-protocol population||Percentage of subjects||95% Confidence Interval|Number
659508|NCT01879540|Primary|Geometric Mean Ratio (GMR) of Post Vaccination Versus Pre Vaccination Geometric Mean Areas (GMAs), Against Each of Three Vaccine Strains After Receiving One Dose of aTIV|"The antibody responses following one dose of aTIV were evaluated in terms of geometric mean ratio GMRs of post vaccination GMAs to pre vaccination GMAs against each of the three vaccine strains, three weeks after receiving one dose of aTIV.
The related European (CHMP) criterion for the assessment of immunogenicity is met if the GMR day 22/day 1 is > 2.0."|Day 22/Day 1|Analysis was done on the per-protocol population||Ratio||95% Confidence Interval|Geometric Mean
659509|NCT01879540|Primary|Percentages of Subjects With Seroconversion or Significant Increase in SRH Area, Against Each of Three Vaccine Strains After Receiving One Dose of aTIV|"Immunogenicity was assessed in terms of percentages of adult subjects ≥65 years of age achieving seroconversion or significant increase in SRH area against each of the three vaccine strains, three weeks after receiving one dose of aTIV.
Seroconversion is defined as percentage of subjects with a pre-vaccination SRH area ≤4mm2 achieving a post-vaccination SRH area ≥25 mm2. Significant increase is defined as percentage of subjects with a pre-vaccination SRH area >4mm2 achieving at least 50% increase in post-vaccination SRH area.
The related European (CHMP) criterion for the assessment of immunogenicity is met if>30% of subjects achieve seroconversion or significant increase in post-vaccination SRH area."|Day 22|Analysis was done on the per-protocol population||Percentage of subjects||95% Confidence Interval|Number
659510|NCT01879540|Primary|Percentages of Subjects With Single Radial Hemolysis (SRH) Areas ≥25mm2, Against Each of Three Vaccine Strains After Receiving One Dose of aTIV|"Immunogenicity was assessed in terms of percentages of adult subjects ≥65 years of age with SRH areas ≥25mm2 against each of the three vaccine strains, three weeks after receiving one dose of aTIV.
The related European Committee for Human Medicinal Products (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving post vaccination SRH areas ≥ 25mm2 is >60%."|Day 1 (baseline) and Day 22|Analysis was done on the per-protocol population i.e all subjects who have received study vaccination and provided immunogenicity data both at baseline and after vaccination; did not withdraw informed consent and did not have Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) confirmed influenza during the study.||Percentage of subjects||95% Confidence Interval|Number
659526|NCT01878825|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 21-day (Days 0-20) post-vaccination period|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.||Subjects|||Number
662325|NCT01824446|Primary|Total Body Clearance (CL/F) of Radio-Labelled SSP-004184|The rate at which a drug is removed from the body.|Up to 288 hours post-dose|PAS||L/hr||Standard Deviation|Mean
659511|NCT01879410|Secondary|Change From Baseline(BL) in Trough Forced Expiratory Volume in One Second (FEV1) at Day 85|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Baseline is defined as the mean of the assessments made 30 and 5 minutes (min) pre-dose on treatment Day 1. Trough FEV1 on Day 85 is defined as the mean of the FEV1 values obtained 23 and 24 hours after morning dosing on Day 84. Analysis was performed using a repeated measures model with covariates of treatment, Baseline (mean of the 2 assessments made 30 min and 5 min pre-dose on Day 1), smoking status, day, day by baseline and day by treatment interactions. The model used all available trough FEV1 values recorded on Days 28, 56, 84, and 85. Missing data were not directly imputed in this analysis; however, all non-missing data for a participant were used within the analysis to estimate the treatment effect for trough FEV1 at Day 85. Change from baseline was calculated as the value at Day 84 minus the value at Baseline.|Baseline and Day 85|ITT Population. Participants analyzed were those with data available at the presented time point; but, all participants without missing covariate information were included in the analysis.||Liters||Standard Error|Least Squares Mean
659512|NCT01879410|Primary|Change From Baseline (BL) in 0 to 24 Hour Weighted Mean Forced Expiratory Volume Over 1 Second (FEV1) at Day 84|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The weighted mean was calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5 and 15 minutes and 1, 3, 6, 9, 12 hours (pre-evening dose), 13, 15, 18, 23, and 24 hours after the morning dose. Baseline is defined as the mean of the assessments made 30 and 5 minutes (min) pre-dose on treatment Day 1. Analysis was performed using an analysis of covariance model with covariates of baseline FEV1 (mean of the two assessments made 30 mins and 5 mins pre-dose on Day 1), smoking status, and treatment. Change from baseline was calculated as the value at Day 84 minus the value at Baseline.|Baseline and Day 84|Intent-to-Treat (ITT) Population: all randomized participants who received at least 1 dose of randomized study drug in the Treatment Period. Participants analyzed were those with data available at the presented time point; but, all participants without missing covariate information and with >= post BL measurement were included in the analysis.||Liters||Standard Error|Least Squares Mean
659513|NCT01879371|Secondary|AUC(0-inf)|AUC(0-inf): area under the concentration-time curve of Ibuprofen in plasma over the time interval from 0 extrapolated to infinity|2 hours (h) before drug administration and 5minutes (min), 10min, 15min, 30min, 45min, 1h, 1h 15min, 1h 30min, 1h 45min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h after drug administration|PKS||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
659514|NCT01879371|Primary|Cmax|Cmax: maximum measured concentration of Ibuprofen in plasma|2 hours (h) before drug administration and 5minutes (min), 10min, 15min, 30min, 45min, 1h, 1h 15min, 1h 30min, 1h 45min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h after drug administration|PKS||μg/mL||Geometric Coefficient of Variation|Geometric Mean
659515|NCT01879371|Primary|AUC(0-tz)|AUC(0-tz): area under the concentration-time curve of Ibuprofen in plasma over the time interval from 0 to the last quantifiable data point|2 hours (h) before drug administration and 5minutes (min), 10min, 15min, 30min, 45min, 1h, 1h 15min, 1h 30min, 1h 45min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h after drug administration|Pharmacokinetic set (PKS): included all treated subjects who provided at least one observation for at least one primary Pharmacokinetic endpoint without important protocol violations.||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
659516|NCT01879345|Secondary|AUC0-τ|Single dose: pharmacokinetic parameters following an oral single-dose of BIA 2-093 Multiple dose: pharmacokinetic parameters following the last dose of an oral 7- day once-daily regimen of BIA 2-093|Day 1 and Day 7|||ng.h/mL||Standard Deviation|Mean
659517|NCT01879345|Secondary|Tmax - the Time of Occurrence of Cmax|Single dose: pharmacokinetic parameters following an oral single-dose of BIA 2-093 Multiple dose: pharmacokinetic parameters following the last dose of an oral 7- day once-daily regimen of BIA 2-093|Day 1 and Day 7|||hours||Standard Deviation|Mean
659518|NCT01879345|Secondary|Cmax - Maximum Observed Plasma Drug Concentration|"Single dose: pharmacokinetic parameters following an oral single-dose of BIA 2-093 Multiple dose: pharmacokinetic parameters following the last dose of an oral 7- day once-daily regimen of BIA 2-093
Oxcarbazepine is a BIA 2-093 metabolite"|Day 1 and Day 7|||ng/mL||Standard Deviation|Mean
659519|NCT01879345|Primary|Number of Adverse Events Reported|investigate the tolerability of two single- and multiple-dose regimens of BIA 2-093 (1800 mg and 2400 mg)considering the Number of adverse events reported by patient|3 weeks|||Number of adverse events reported|||Number
659520|NCT01879332|Primary|Number of Adverse Events Reported|Safety was evaluated through the recording and monitoring of adverse events|2 days|||Number of adverse events reported|||Number
659521|NCT01879319|Secondary|Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
659522|NCT01879319|Primary|Percentage of Participants With Full Administration of Evolocumab at Both Weeks 4 and 8|Self-administration of evolocumab was assessed by a telephone interview at Weeks 4 and 8. Each participant was asked about all attempted injection(s) and if the injection was administered in part, full, or none at all. Results only include full administrations that occurred inside the prespecified visit window.|Weeks 4 and 8|Full analysis set||Percentage of participants||95% Confidence Interval|Number
659523|NCT01879176|Primary|IL-6||1. Preoperative 2. Before CBP 3. After CPB 4. 2 hours after CPB 5. 24 hours 6. 48 hours 7. 120 hours|||pg/ml||Inter-Quartile Range|Median
659524|NCT01879059|Primary|Effects of Physical Inactivity on Post Prandial Blood Flow|There was a pre-measurement period of 3 days, then 5 days of inactivity, followed by 1.5-2 days of return to activity. A 10 day time frame overall. Blood flow measured by Doppler ultrasound during an oral glucose tolerance test before and after 5 days of inactivity.|10 days|healthy, young, active men||percentage of change in blood flow||Standard Deviation|Mean
659525|NCT01878825|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs)|A serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination.|During the entire study period (Days 0-20 post vaccination)|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.||Subjects|||Number
659527|NCT01878825|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, increased sweating and fever [oral temperature above 37.5 degrees Celsius (°C)]. Gastrointestinal symptoms included nausea, vomiting, diarrhea and/or abdominal pain. Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = oral temperature above 39.0°C|During the 4-day (Days 0-3) post-vaccination period|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.||Subjects|||Number
659528|NCT01878825|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.|Solicited local symptoms assessed were ecchymosis, induration, pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal everyday activities. Grade 3 ecchymosis, induration, redness and swelling was greater than 100 millimeters (mm) i.e. >100mm.|During the 4-day (Days 0-3) post-vaccination period|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.||Subjects|||Number
659529|NCT01878825|Secondary|Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains.|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata). This outcome measure was assessed by influenza vaccination status in subjects (18-60 years and >60 years) who had and who had not received an influenza vaccine during the 2012/2013 influenza season.|At Day 0 and Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
659530|NCT01878825|Secondary|Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains.|MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata). This outcome measure was assessed by influenza vaccination status in subjects (18-60 years and >60 years) who had and who had not received an influenza vaccine during the 2012/2013 influenza season.|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Fold increase||95% Confidence Interval|Geometric Mean
659531|NCT01878825|Secondary|Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Influenza Strains.|A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).This outcome measure was assessed by influenza vaccination status in subjects (18-60 years and >60 years) who had and who had not received an influenza vaccine during the 2012/2013 influenza season.|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
659532|NCT01878825|Secondary|Humoral Immune Response in Terms of HI Antibody Titers Against Each of the Three Vaccine Influenza Strains|Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata). This outcome measure was assessed by influenza vaccination status in subjects (18-60 years and >60 years) who had and who had not received an influenza vaccine during the 2012/2013 influenza season.|At Days 0 and Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Titers||95% Confidence Interval|Geometric Mean
659533|NCT01878825|Primary|Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains.|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).|At Days 0 and Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
659534|NCT01878825|Primary|Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains.|MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Fold increase||95% Confidence Interval|Geometric Mean
659545|NCT01878812|Secondary|Number of Days of Solicited Local Symptoms|Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling. The number of days is expressed as a mean value.|During the entire study period (Days 0 to 21)|The analysis was based on the Total Vaccinated cohort, which included all subjects with the study vaccine administered with the respective symptoms reported.||Days||Inter-Quartile Range|Mean
659535|NCT01878825|Primary|Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Influenza Strains.|A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
659536|NCT01878825|Primary|Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Influenza Strains|Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).|At Days 0 and 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Titer||95% Confidence Interval|Geometric Mean
659537|NCT01878812|Secondary|Mean Geometric Increase (MGI) for HI Antibody Titer Against the 4 Flu Strains of Influenza Virus by Vaccination Status|The strains are: Flu A/Christchurch/16/2010 H1N1 HI, (referred to as Flu A/Christch/16/2010 H1N1), Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata), Flu B/Brisbane/60/2008 Victoria HI. MGI was defined as the fold increase in serum HI geometric mean titers post-vaccination compared to Day 0. Vaccination status is presented as Y = vaccinated or N = not vaccinated during the 2012-2013 season.|At Day 21|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with results available at the specified timepoint.||Titers||95% Confidence Interval|Geometric Mean
659538|NCT01878812|Secondary|Number of Seroconverted Subjects Against 4 Strains of Influenza Virus by Vaccination Status|The strains are: Flu A/Christchurch/16/2010 H1N1 HI, (referred to as Flu A/Christch/16/2010 H1N1), Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata), Flu B/Brisbane/60/2008 Victoria HI. A seroconverted subject is defined as a subject with either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least 4-fold increase in post-vaccination titer. Vaccination status is presented as Y = vaccinated or N = not vaccinated during the 2012-2013 season.|At Day 21|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with results available at the specified timepoint.||Subjects|||Number
659539|NCT01878812|Secondary|Number of Seroprotected Subjects Against 4 Strains of Influenza Virus by Vaccination Status|The strains are: Flu A/Christchurch/16/2010 H1N1 HI, (referred to as Flu A/Christch/16/2010 H1N1), Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata), Flu B/Brisbane/60/2008 Victoria HI. A seroprotected subject is defined as a subject with serum HI titre ≥ 1:40. Vaccination status is presented as Y = vaccinated or N = not vaccinated during the 2012-2013 season.|At Day 21|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with results available at the specified timepoint.||Subjects|||Number
659540|NCT01878812|Secondary|Anti-HI Antibody Titers Against 4 Strains of Influenza Virus by Vaccination Status|The strains are: Flu A/Christchurch/16/2010 H1N1 HI, (referred to as Flu A/Christch/16/2010 H1N1), Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata), Flu B/Brisbane/60/2008 Victoria HI. Titers are presented as geometric mean titers (GMTs). Vaccination status is presented as Y = vaccinated or N = not vaccinated during the 2012-2013 season.|At Days 0 and 21|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with results available at the specified timepoint.||Titers||95% Confidence Interval|Geometric Mean
659541|NCT01878812|Secondary|Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs).|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|At Days 0 and 21|||Subjects|||Number
659542|NCT01878812|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During a 4-day follow-up period after vaccination (i.e. day of vaccination and 3 subsequent days)|||Subjects|||Number
659543|NCT01878812|Secondary|Number of Days of Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, sweating and temperature [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)],. Any = occurrence of the symptom regardless of intensity grade. The number of days is expressed as a mean value.|During a 4-day follow-up period after vaccination (i.e. day of vaccination and 3 subsequent days)|The analysis was based on the Total Vaccinated cohort, which included all subjects with the study vaccine administered with the respective symptoms reported.||Days||Inter-Quartile Range|Mean
659544|NCT01878812|Secondary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, sweating and temperature [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)],. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During a 4-day follow-up period after vaccination (i.e. day of vaccination and 3 subsequent days)|||Subjects|||Number
659546|NCT01878812|Secondary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 ecchymosis/induration/redness/swelling = ecchymosis/induration/redness/swelling spreading beyond 100 millimeters (mm) of injection site.|During a 21-day follow-up period after vaccination (i.e. day of vaccination and 20 subsequent days)|||Subjects|||Number
659547|NCT01878812|Primary|Seroprotection Powers (SPP) for HI Antibody Titer Against the 4 Flu Strains of Influenza Disease|The strains are: Flu A/Christchurch/16/2010 H1N1 HI, (referred to as Flu A/Christch/16/2010 H1N1), Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata), Flu B/Brisbane/60/2008 Victoria HI. SPP is defined as the percentage of subjects who had a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:40.|During a 4-day follow-up period after vaccination (i.e. day of vaccination and 3 subsequent days)|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with results available at the specified timepoint.||Percentage of subjects|||Number
659548|NCT01878812|Primary|Mean Geometric Increase (MGI) for HI Antibody Titer Against the 4 Flu Strains of Influenza Disease|The strains are: Flu A/Christchurch/16/2010 H1N1 HI, (referred to as Flu A/Christch/16/2010 H1N1), Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata) Flu B/Brisbane/60/2008 Victoria HI. MGI was defined as the fold increase in serum HI geometric mean titers post-vaccination compared to Day 0.|At Day 21|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with results available at the specified timepoint.||Fold increase||95% Confidence Interval|Geometric Mean
659549|NCT01878812|Primary|Number of Seroconverted Subjects Against 4 Strains of Influenza Disease|The strains are: Flu A/Christchurch/16/2010 H1N1 HI,(referred to as Flu A/Christch/16/2010 H1N1), Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata), Flu B/Brisbane/60/2008 Victoria HI. A seroconverted subject is defined as a subject with either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least 4-fold increase in post-vaccination titer.|At Day 21|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with results available at the specified timepoint.||Subjects|||Number
659550|NCT01878812|Primary|Number of Seroprotected Subjects Against 4 Strains of Influenza Disease|The strains are: Flu A/Christchurch/16/2010 H1N1 HI, Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI,(referred to as Flu B/Mass/2/2012 Yamagata), Flu B/Brisbane/60/2008 Victoria HI. A seroprotected subject is defined as a subject with serum HI titre ≥ 1:40.|At Day 21|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with results available at the specified timepoint.||Subjects|||Number
659551|NCT01878812|Primary|Anti-HI Antibody Titers Against 4 Strains of Influenza Disease|The strains assessed were: Flu A/Christchurch/16/2010 H1N1 HI, Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata) ,Flu B/Brisbane/60/2008 Victoria HI. Titers are presented as geometric mean titers (GMTs).|At Days 0 and 21|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with results available at the specified timepoint.||Titers||95% Confidence Interval|Geometric Mean
659552|NCT01878799|Primary|Percentage of Participants With Achieved SVR12 (HCV RNA <LLOQ 12 Weeks After Completion of Treatment)|The primary end point was sustained virologic response [plasma HCV RNA level <12 IU/mL by real-time HCV assay (Abbott)] at 12 weeks after treatment completion (SVR12) among all patients enrolled in the study.|12 weeks after completion of treatment|The analysis included all subjects who received at least one dose of study treatment.||percentage of participants||95% Confidence Interval|Number
659553|NCT01878656|Other Pre-specified|Sense of Suffocation|The outcomes assessor will evaluate the sense of suffocation using a numeric rating scale(NRS). (0 = no sense of suffocation, 10 = unimaginably severe sense of suffocation)|Participants will be followed for the duration of postanesthesia care unit (PACU) stay, an expected average of 1 hour.||||||
659554|NCT01878656|Other Pre-specified|Postoperative Pain|The outcomes assessor will evaluate the degree of postoperative pain using a numeric rating scale (NRS). (0 = no pain, 10 = unimaginable severe pain)|Participants will be followed for the duration of postanesthesia care unit (PACU) stay, an expected average of 1 hour.||||||
659555|NCT01878656|Secondary|The Time to Extubation|We will evaluate the time from gas discontinuation to extubation. We will conduct an extubation when participants can show responses such as eye opening or nodding one's head to our verbal commands.|Participants will be followed from the time of gas discontinuation in operating room to the time of discharge from postanesthesia care unit(PACU), an expected average of 1 hour.||||||
659556|NCT01878656|Primary|The Incidence of Emergence Agitation Using Four-point Categorical Scale|The outcomes assessor will evaluate the severity of emergence agitation of participants using a four-point categorical scale. (1: calm, 2: not calm, but could be easily calmed, 3: moderately agitated or restless, 4: combative, excited, disoriented) We considered presence of emergence agitation as 3 and 4 of four-point scale.|Participants will be followed from the time of gas discontinuation in operating room to the time of discharge from postanesthesia care unit(PACU), an expected average of 1 hour.|||participants|||Number
659557|NCT01878604|Secondary|LDL-C Reduction Percentage|"plasma LDL-C reduction percentage with lipid-lowering drugs from pre-treatment to the last time follow-up time point
plasma LDL-C reduction percentage calculation: plasma LDL-C at pre-treatment time point minus plasma LDL-C at the last time follow-up time point, and then compared with plasma LDL-C at pre-treatment time point, namely plasma LDL-C reduction percentage."|pre-treatment and 6-13 years post treatment|||percentage of plasma LDL-C reduction||Standard Error|Mean
659558|NCT01878604|Primary|Number of LDLR Gene Mutations|"Number of gene mutations based on the sequencing results in terms of some known genes and suspected novel genes.
c.796 G>C and c.1048 C>T in the LDLR gene c.1448 G>A and c.1720C>A in the LDLR gene c.2030 G >A and c.1257 C>A in the LDLR gene homozygous mutation c.605 T>C in the LDLR gene"|1 year|||gene mutations|||Number
659559|NCT01878526|Secondary|Changing of the Quality of Life Which is Evaluated by EQ-5DTM|VAS scale 0-100 was applied for an outcome measurement of the quality of life. The VAS scale 0 was the worst quality of life and scale 100 was the best quality of life. The changing of the quality of life was the changing of VAS of quality of life before and after treatment.|8 weeks|||VAS (100)||Standard Deviation|Mean
659560|NCT01878526|Secondary|the Prevalence of Omeprazole-resistant GERD in SSc After 4 Weeks Treatment With Omeprazole||4 weeks|The number of analysed patients came out the total number of screening patients in the trial. The patients who were defined as omeprazole-resistant GERD were enrolled and randomized for either alginic acid plus placebo or domperidone plus placebo group.||percentage of participants||95% Confidence Interval|Number
659561|NCT01878526|Secondary|Changing of Frequency of Symptoms in SSc Related Omeprazole Resistant GERD Evaluated by Frequency Scale for the Symptoms of GERD (FSSG)|Unit scale 0-48 was applied for an outcome measurement of the frequency of symptoms. The unit scale 0 was no symptom and scale 48 was usual symptom of GERD. The changing of the frequency of symptoms was the changing of the unit scale before and after treatment.|8 weeks|||units on a scale||Standard Deviation|Mean
659562|NCT01878526|Primary|Changing of the Severity of Regurgitation|VAS scale 0-100 was applied for an outcome measurement of the severity of regurgitation. The VAS scale 0 was no symptoms of regurgitation and scale 100 was a maximum symptom of regurgitation. The changing of the severity of regurgitation was the changing of VAS before and after treatment.|8 weeks|||VAS (100)||Standard Deviation|Mean
659563|NCT01878526|Primary|Changing Severity of Heart Burn of SSc Related Omeprazole Resistant GERD Evaluated by Visual Analogue Score (VAS)|VAS scale 0-100 was applied for an outcome measurement of the severity of heart burn. The VAS scale 0 was no symptoms of heart burn and scale 100 was a maximum symptom of heart burn. The changing of the severity of heart burn was the changing of VAS before and after treatment.|8 weeks|||VAS (100)||Standard Deviation|Mean
659564|NCT01878214|Secondary|Changes in Motivation to Quit Smoking and Thinking About Quitting Smoking|"At baseline and follow-up, subjects will answer questions about motivation to quit smoking (How motivated are you to quit smoking at this time? [scale: 1 (not at all) - 10 (extremely)]) and thinking about quitting smoking (Each rung on this ladder represents where various smokers are in their thinking about quitting. Circle the number that indicates where you are now. [0 (no thoughts of quitting) -10 (taking action to quit)]). We will report the % of subjects who reported more motivation to quit and greater thinking about quitting at follow-up compared to baseline. We will compare the intervention group with the control group."|7 months after recruitment|Secondary outcomes were collected via self-report survey approximately 7 months after study enrollment; 345 subjects (78%) completed the follow-up survey. This outcome was only measured in those who reported smoking in the last 30 days (n=288, 83.5%).||percentage of participants|||Number
659565|NCT01878214|Secondary|Changes in Readiness to Quit Smoking in the Next 6 Months|"Subjects will answer the following question at both baseline and follow-up surveys: Are you seriously considering quitting smoking in the next 6 months? [yes/no]. We will report % of subjects who said no at baseline and yes at follow-up to determine changes in readiness to quit smoking and compare between intervention and control groups."|7 months after recruitment|Secondary outcomes were collected via self-report survey approximately 7 months after study enrollment; 345 subjects (78%) completed the follow-up survey. This outcome was only measured in those who reported smoking in the last 30 days (n=288, 83.5%).||percentage of participants|||Number
659566|NCT01878214|Secondary|Changes in Smoking Behaviors (Frequency and Quantity)|"At baseline and follow-up, subjects will report smoking frequency (How often do you smoke? [everyday, at least 4 days/week, 1-3 days/week, less than one day/week]) and quantity (On days that you smoke, how many cigarettes do you have per day? [10 or less, 11-20, 21-30, 31 or more]). We will report the % of subjects who smoke less frequently and smoke fewer cigarettes per day at follow-up compared to baseline. We will compare the intervention group with the control group."|7 months after recruitment|Secondary outcomes were collected via self-report survey approximately 7 months after study enrollment; 345 subjects (78%) completed the follow-up survey. This outcome was only measured in those who reported smoking in the last 30 days (n=288, 83.5%).||percentage of participants|||Number
659567|NCT01878214|Secondary|Quit Smoking|"At follow-up, subjects will report current smoking status. (Do you currently smoke (have you smoked in the last 30 days)? [Yes, I smoked within the past 30 days; No, but I have smoked in the past 6 months; No, and I have not smoked in more than 6 months]). We will report the % of subjects who have not smoked in the last 30 days and will compare the intervention group with the control group."|7 months after baseline|Secondary outcomes were collected via self-report survey approximately 7 months after study enrollment; 345 subjects (78%) completed the follow-up survey.||percentage of participants|||Number
659568|NCT01878214|Primary|Enrollment in Smoking Cessation Program|Enrollment records from the union-sponsored smoking cessation program|up to 12 months after recruitment|Includes all study subjects||participants|||Number
659569|NCT01878175|Secondary|Change in Lower Quarter Y-balance Test (YBT-LQ)|The YBT-LQ is a test of dynamic balance in unilateral stance . It will be administered to all patients who pass a clearance test, which consists of being able to stand on one leg for 10 seconds. The YBT-LQ is performed for both left and right limbs. Any trial that is failed will be repeated with a maximum of 4 additional trials to be performed in each reach direction, anterior, posterior, and lateral. NOTE: Only although 13 participants began the clearance test at both time points, only 5 participants were able to pass the clearance test required to do the YBT-LQ at 6 weeks. Therefore we have not provided a change score for YBT-LQ since this would involve a very small number of participants, and we are concerned about validity of the results that would be presented since those who completed the test at 6 weeks may be a biased sample. We therefore provide the difference (post minus pre) in the # of participants who completed the clearance test at 15 weeks (9) vs. 6 weeks (5).|Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)|Number of participants who performed the clearance test for the YBT-LQ at both 6 weeks and 15 weeks.||Number of participants|||Number
659576|NCT01878175|Secondary|Global Assessment of Hip Symptom Change|We will use the Patient Global Impression of Change scale to evaluate participants' perspectives on overall change in their joint pain in their (one) operative hip during the study period. This single-item measure asks participants to describe their change in pain on a rating scale with the following 13 options: a little worse, somewhat worse, moderately worse, a good deal worse, a great deal worse, a very great deal worse, about the same, a little better, somewhat better, moderately better, a good deal better, a great deal better, a very great deal better. The total scale range is -6 to +6. Negative scores indicate greater perceived improvement.|15 weeks (post-intervention)|Number of participants who completed this measure at 15 week follow-up. Two participants were withdrawn from the study before 15 weeks, and two additional participants did not complete this item at the 15 week follow up assessment.||units on a scale||Standard Deviation|Mean
659570|NCT01878175|Secondary|Change in Harris Hip Score (HHS)|The HHS is the most widely used physician- or therapist-assessed measure of hip function following THA and associated rehabilitation. Although the HHS has also been used in a patient-report format, in this study we will obtain this measure via therapist report, to complement the patient-reported outcomes described above. This measure covers the domains of pain (severity and effects on activities and need for pain medication, function (daily activities and gait), deformity (hip flexion, adduction, internal rotation, and extremity length discrepancy) and range of motion (hip flexion, abduction, internal and external rotation, and adduction). The HHS includes 10 items, with a total score range of 0-100; higher scores indicating better function. The HHS has been shown to be a reliable and valid measure of hip function. Change was defined as pre-intervention minus post-intervention. Therefore a negative change score indicates improvement over time.|Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)|Number of participants who completed the test at 6 weeks and 15 weeks. Two participants were withdrawn from the study before 15 weeks.||units on a scale||Standard Deviation|Mean
659571|NCT01878175|Secondary|Change in University of California Los Angeles (UCLA) Activity Questionnaire|The UCLA scale shows a strong correlation with the other measures (r = -0.35 to 0.56 for THA; r = -0.55 to 0.23 for TKA) and discriminates between insufficiently and sufficiently active patients undergoing THA and TKA. The UCLA scale has good reliability, provides high completion rate, and shows no floor effects. It seems to be the most appropriate scale for assessment of physical activity levels in patients undergoing total joint arthroplasty. The UCLA scale is a simple scale ranging from 1 to 10. The patient indicates her or his most appropriate activity level, with 1 defined as 'no physical activity, dependent on others' and 10 defined as 'regular participation in impact sports.' Change was defined as pre-intervention minus post-intervention. Therefore a negative change score indicates improvement over time.|Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)|Number of participants who completed the test at 6 weeks and 15 weeks. Two participants were withdrawn from the study before 15 weeks.||units on a scale||Standard Deviation|Mean
659572|NCT01878175|Secondary|Change in Objective Functional Test: Stair Climbing|The task of stair climbing has been found to be sensitive to change with interventions in individuals with knee OA. This measures the time it takes a participant to ascend and descend a flight of 12 steps (each step 18 cm high and 28 cm deep). Participants will be asked to complete the test as quickly as they felt safe and comfortable. The use of one handrail will be allowed if necessary, but patients will be encouraged to minimize their use of the handrail. One practice trial will be performed and the average of two additional tests will be used for analysis. The use of an assistive device will be allowed only if the subject will be unsafe or cannot complete the test without the use of the device. Change was defined as pre-intervention minus post-intervention. Therefore a positive change score indicates improvement over time.|Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)|Number of participants who completed this measure at 6 weeks and 15 weeks. Two participants were withdrawn from the study before 15 weeks, and one additional participant did not complete this test at both time points.||seconds||Standard Deviation|Mean
659573|NCT01878175|Secondary|Change in Objective Functional Test: Walking Speed|Gait speed is a global measure of disability and function and has been correlated with disease processes, fitness level, activities of daily living, and emotional states. In addition, gait speed is an imperative measure for integration to safe and effective community ambulatory status, and has been defined as a reflective measure of function. Walking speed will be determined as the average walking speed over a 3 meter walk. Participants will be asked to walk down a 10 meter walkway 7 times (while wearing standard footwear) to have their walking speed monitored using infrared photocells, while speed is monitored over the middle 3 meters. These seven trials will be averaged in order to determine walking speed at each of the three visits. Change was defined as pre-intervention minus post-intervention. Therefore a negative change score indicates improvement over time.|Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)|Number of participants who completed this test at 6 weeks and 15 weeks. Two participants were withdrawn from the study before 15 weeks, and one additional participant did not complete this test at both time points.||m/sec||Standard Deviation|Mean
659574|NCT01878175|Secondary|Change in Objective Functional Test: Sit to Stand|The Sit-to-Stand Test has been reported to be a good indicator of postural control, fall risk, lower-extremity strength, and disability. During the sit-to-stand test participants will be asked to place their arms across their chest and keep their feet flat on the floor. They will then be asked to stand up and sit down 5 times as fast as they can. This will be repeated twice and the scores will be averaged for analysis. Change was defined as pre-intervention minus post-intervention. Therefore a positive change score indicates improvement over time.|Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)|Number of participants who completed this test at 6 and 15 weeks. Two participants were withdrawn from the study before 15 weeks, and two additional participants did not complete this test at both time points.||seconds||Standard Deviation|Mean
659575|NCT01878175|Secondary|Change in Objective Functional Test: Timed Get Up-and-go|The timed get up-and-go test has demonstrated excellent reliability and correlates well with other standard measures such as gait speed, self-report and clinical report indices of function, and is predictive of who can safely ambulate. This test requires the participants to stand from a standard arm chair, walk 3 meters and then return to sitting in the same chair. Participants are asked to complete this as quickly and safely as possible, without the use of an assistive device. Change was defined as pre-intervention minus post-intervention. Therefore a positive change score indicates improvement over time.|Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)|Number of participants who completed this test at both 6 weeks and 15 weeks. Two participants were withdrawn from the study before 15 weeks, and one additional participant did not complete this assessment at both time points.||seconds||Standard Deviation|Mean
659586|NCT01878097|Secondary|Violence Acceptance|Two measures used: Illinois Rape Myth Acceptance Scale measure students' beliefs about rape which may indicate social norms supporting sexual violence. 5-item Acceptance of General Dating Violence Scale(21) was used to measure norms supporting dating violence.|Annual measures violence at baseline (pre-intervention) and 4 years post intervention||10/2017||||
659577|NCT01878175|Secondary|Change in Satisfaction With Physical Function Questionnaire|This is a validated 5-item questionnaire that assesses patients' satisfaction with their ability to complete basic functional tasks that are often affected by lower extremity osteoarthritis (OA), including stair-climbing, walking, doing housework (light and heavy), and lifting and carrying. The scale range is -15 to +15, with higher scores indicating more satisfaction with function. Change was defined as post-intervention minus pre-intervention. Therefore a positive change score indicates improvement over time.|Change between Pre-intervention (post-surgery) to post-intervention (15 weeks post-surgery)|Number of participants who completed the measure at baseline and 15 weeks. Two participants were withdrawn before 15 weeks.||units on a scale||Standard Deviation|Mean
659578|NCT01878175|Primary|Change Hip Disability and Osteoarthritis Outcomes (HOOS) - Quality of Life Subscale|The HOOS is a validated outcome measure in patients with painful hip conditions. It contains 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. Change was defined as pre-intervention minus post-intervention. Therefore a negative change score indicates improvement over time.|Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)|Number of participants who completed the HOOS Quality of Life scale at 6 weeks and 15 weeks. Two participants were withdrawn from the study before 15 weeks.||units on a scale||Standard Deviation|Mean
659579|NCT01878175|Primary|Change in Hip Disability and Osteoarthritis Outcomes (HOOS) Score - Symptom Subscale|The HOOS is a validated outcome measure in patients with painful hip conditions. It contains 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. Change was defined as pre-intervention minus post-intervention. Therefore a negative change score indicates improvement over time.|Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)|Number of participants who completed the HOOS Symptoms subscale at 6 weeks and 15 weeks. Two participants were withdrawn from the study before 15 weeks.||units on a scale||Standard Deviation|Mean
659580|NCT01878175|Primary|Change in Hip Disability and Osteoarthritis Outcomes (HOOS) Score - Sport Subscale|The HOOS is a validated outcome measure in patients with painful hip conditions. It contains 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. Change was defined as pre-intervention minus post-intervention. Therefore a negative change score indicates improvement over time.|Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)|Number of participants who completed the HOOS Sport subscale at 6 weeks and 15 weeks. Two participants were withdrawn from the study before 15 weeks, and one additional participant did not complete all items on this subscale at both time points and therefore could not be given a score, per scale scoring instructions.||units on a scale||Standard Deviation|Mean
659581|NCT01878175|Primary|Change in Hip Disability and Osteoarthritis Outcomes Score (HOOS) - Pain Scale|The HOOS is a validated outcome measure in patients with painful hip conditions. It contains 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. Change was defined as pre-intervention minus post-intervention. Therefore a negative change score indicates improvement over time.|Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)|Number of participants who completed the HOOS pain subscale at 6 weeks and 15 weeks. Two participants were withdrawn from the study before 15 weeks.||units on a scale||Standard Deviation|Mean
659582|NCT01878175|Primary|Change in Hip Disability and Osteoarthritis Outcomes Score (HOOS) - Activities of Daily Living Scale|The HOOS is a validated outcome measure in patients with painful hip conditions. It contains 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. Change was defined as pre-intervention minus post-intervention. Therefore a negative change score indicates improvement over time.|Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)|Individuals who completed the HOOS ADL scale at 6 weeks and 15 weeks. Two participants were withdrawn from the study before 15 weeks.||units on a scale||Standard Deviation|Mean
659583|NCT01878149|Secondary|Safety|Incidence of short term peri-operative adverse events (out to 6 months post-implant) including thigh pain, numbness, paresthesia and transient leg weakness.|Observed for up to 6 months post-surgery||||||
659584|NCT01878149|Primary|Safety: Number of Participants Without Major Device-related Adverse Events and/or Failures|Incidence of major device-related adverse events and/or failures, defined as those requiring revision surgery or a secondary operation, or events resulting in permanent disability or death.|Observed for up to 6 months post-surgery|It was anticipated that approximately 40 subjects would be enrolled across the participating sites; 20 subjects in each treatment arm. Consecutive subjects who were treated with LLIF using the VEO® or XLIF® systems at least 3 months prior to the the data collection were included. The planned sample size was not statistically derived.||participants|||Number
659585|NCT01878097|Secondary|Social Networks|Measure of how the bystander intervention is diffused throughout student social networks. Each trained student provides the names of 5 friends / acquaintances. Analyses measures the numbers of students indirectly receiving training via trained student. Panel surveys also measure impact of diffusion through observing others' bystanding behaviors|Annual measures violence at baseline (pre-intervention) and 4 years post intervention|No usable data were collected.|||||
659587|NCT01878097|Secondary|Increase in Bystanding Behaviors|"7 items measuring self-reports of students actively engaging their peers in behaviors that may prevent violence.
Response options: 0 times, 1-2 times, 3-5 times, 6-9 times, 10 or more times, didn’t see or hear someone doing this
Tell someone to stop talking down to, harassing, or messing with someone else.
Speak up when you heard that someone who was forced to have sex or hurt by a boyfriend/girlfriend was to blame.
Talk to a friend who was being physically hurt by a boyfriend/girlfriend.
Ask someone that looked very upset at a party if they were okay or needed help.
Ask a friend if they needed to be walked or driven home from a party if they looked upset.
Spoke up to someone who was bragging or making excuses for forcing someone to have sex with them.
Got help for a friend because they had been forced to have sex or were physically hurt by a boyfriend/girlfriend.
Above items repeated to measure student observing others doing these behaviors."|Annual measures violence at baseline (pre-intervention) and 4 years post intervention||10/2017||||
659588|NCT01878097|Primary|Average Number of Sexual Assaults Experienced (Victimization) Events Per School.|Students self report of sexual assault victimization averaged at the school level and adjusted for baseline and number of students. Adjustments made by including baseline measure and number of students as covariates in models.|over 5 years with baseline intervention|anonymous survey data collected over 5 years and sorted by intervention. To keep ITT analysis, all schools were included and data were imputed for schools that dropped out.||Number of events per school|Schools|95% Confidence Interval|Least Squares Mean
659589|NCT01878097|Primary|Average Number of Sexual Assault Events Used (Perpetrated) Per School.|Students self report of sexual assault perpetration averaged at the school level and adjusted for baseline and number of students. Adjustments were made by including baseline measure and number of students as a covariate in the model.|over 5 years with baseline intervention|Anonymous survey data collected over 5 years and sorted by intervention. To complete ITT analysis, schools that dropped out were included in analysis using imputed data.||Number of events per school|Schools|95% Confidence Interval|Least Squares Mean
659590|NCT01877941|Primary|Cardiac Output as Measured by ECOM|Measurements of cardiac output derived from the Endotracheal Cardiac Output Monitor (ECOM): An FDA-approved medical device is inserted into the patient's throat; cardiac output is calculated by measuring how electricity moves through the chest.|During and post-surgery, up to 8 hours|Supplies for the ECOM device were not available so it was not tested.|||||
659591|NCT01877941|Primary|PAC (Pulmonary Artery Catheter).|"Measurements of cardiac output derived from a PAC (pulmonary artery catheter) using the standard thermodilution technique. At each time point, at least 6 measurements were taken. If, in the opinion of the clinician taking the readings, some of these were in error, more readings were taken to ensure accuracy. In no case were more than 18 readings taken. The points deemed valid by the clinician were averaged to obtain the reference value for that time point. The mean and standard deviation reported consisted of the reference values from all time points measured.
Data for this test were taken at the following timepoints:
1. Start of Sterenotomy; 2. Before Bypass; 3. 30 Min after bypass; 4. Closure; 5. ICU arrival; 6. 6 hours in ICU; 7. 12 Hours in ICU; 8. 18 Hours in ICU (if PAC still in); 9. 24 Hours in ICU (If PAC still in)"|During and post-surgery, up to 24 hours|||liters/minute||Standard Deviation|Mean
659592|NCT01877941|Primary|esCCO (Estimated Continuous Cardiac Output) Monitor|"6 Measurements of cardiac output derived from pulse oximeter measurements using the esCCO system were taken at each time point. The measurements deemed valid under the criteria in the protocol were averaged to represent the reference value at that point. The mean and standard deviation reported consist of the reference values from all time points measured.
Data for this test were taken at the following timepoints:
1. Start of Sterenotomy; 2. Before Bypass; 3. 30 Min after bypass; 4. Closure; 5. ICU arrival; 6. 6 hours in ICU; 7. 12 Hours in ICU; 8. 18 Hours in ICU (if PAC still in); 9. 24 Hours in ICU (If PAC still in)"|During and after surgery, up to 24 hours|||liters/minute||Standard Deviation|Mean
659593|NCT01877720|Secondary|Respiratory Rate||last 5-min of each 15-min trial||||||
659594|NCT01877720|Secondary|Blood Pressure|systolic, diastolic and mean blood pressure measured by non-invasive cuff|last 5-min of each 15-min trial||||||
659595|NCT01877720|Secondary|Heart Rate||last 5-min of each 15-min trial||||||
659596|NCT01877720|Secondary|SpO2|transcutaneous peripheral saturation of oxygen by pulse oximeter|last 5-min of each 15-min trial||||||
659597|NCT01877720|Secondary|Asynchrony Index|"total number of each event per minute
ineffective efforts: presence of a characteristic EAdi (electrical activity of diaphragm) activity not followed by a ventilator delivered pressurization
auto-triggering: a cycle delivered by the ventilator without EAdi signal
premature cycling
delayed cycling: VPT > NIT x2
double triggering
Asynchrony index = [(1)+(2)+(3)+(4)+(5)]/[(1)+pneumatic respiratory rate] x100"|last 5-min of each 15-min trial|||percentage of neural respiration||Inter-Quartile Range|Median
659598|NCT01877720|Secondary|All Asynchrony Events||last 5-min of each 15-min trial|||events per min||Inter-Quartile Range|Median
659599|NCT01877720|Secondary|Leakage|[TVi (inspiratory tidal volume) - TVe (expiratory tidal volume)]/TVi (inspiratory tidal volume)|last 5-min of each 15-min trial|||percentage of inspiratory tidal volume||Standard Deviation|Mean
659600|NCT01877720|Secondary|Swing EAdi||last 5-min of each 15-min trial|||uV||Standard Deviation|Mean
659601|NCT01877720|Secondary|Maximum EAdi||last 5-min of each 15-min trial|||uV||Standard Deviation|Mean
659602|NCT01877720|Secondary|Pneumatic Respiratory Rate||last 5-min of each 15-min trial|||breaths per min||Standard Deviation|Mean
659603|NCT01877720|Secondary|Peak Inspiratory Pressure||last 5-min of each 15-min trial|||cmH2O||Standard Deviation|Mean
659604|NCT01877720|Secondary|Minute Ventilation Volume|inspiratory tidal volume / respiratory rate|last 5-min of each 15-min trial|||mL/kg/min||Standard Deviation|Mean
659605|NCT01877720|Secondary|Ti_excess (Inspiratory Time in Excess)|"Ti_excess = (VPT-NIT)/NIT
VPT: ventilator pressurization time (VPT) between beginning and end of inspiratory flow NIT: neural inspiratory time (NIT) between beginning of the increase in the diaphragmatic excitation and its maximal value"|last 5-min of each 15-min trial|||percentage of neural inspiratory time||Standard Deviation|Mean
659606|NCT01877720|Primary|Trigger Delay|Inspiratory trigger delay could be calculated by the time interval between beginning of the increase of actual diaphragmatic excitation and start of ventilator inspiratory flow of each respiration. The value will be present as a mean of all inspiratory trigger delay measurements of all respiration during last 5 minutes of each 15 minutes trial.|last 5-min of each 15-min trial|||ms||Standard Deviation|Mean
659607|NCT01877668|Secondary|Change From Baseline in Scores Evaluating Spondylitis Using the Bath Anklyosing Spondylitis Disease Activity Index (BASDAI)|BASDAI is a validated self-assessment tool used to determine disease activity in participants with ankylosing spondylitis. Utilizing a visual analog scale of 0-100mm (0=none and 100=very severe) participants answer 6 questions measuring discomfort, pain, and fatigue. The final BASDAI score averages the individual assessments for a final score ranging 0-10cm, with higher scores representing more severe ankylosing spondylitis disease activity.|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug with presence of spondylitis at screening and baseline BASDAI score>0 cm and were evaluable. n=number of participants evaluable at each visit.||cm||Standard Error|Least Squares Mean
659608|NCT01877668|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Impact Domain Score|FACIT-F is a 13-item questionnaire, with each item score ranging from 0 to 4. Three endpoints are derived: change in FACIT-F total score, change in FACIT-F experience domain score, and change in FACIT-F impact domain score. FACIT-F total score (range 0-52) is calculated by summing the 13 items. FACIT-F experience domain score (range 0-20) is calculated by summing 5 items : I feel fatigued, I feel weak all over, I feel listless (“washed out”), I feel tired, and I have energy, while FACIT-F impact domain score (range 0-32) is calculated by summing the remaining 8 items. All responses are added with equal weight to obtain the total score. Higher scores represent better (less) fatigue impact on daily functioning.|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.||Units on a scale||Standard Error|Least Squares Mean
659609|NCT01877668|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Experience Domain Score|FACIT-F is a 13-item questionnaire, with each item score ranging from 0 to 4. Three endpoints are derived: change in FACIT-F total score, change in FACIT-F experience domain score, and change in FACIT-F impact domain score. FACIT-F total score (range 0-52) is calculated by summing the 13 items. FACIT-F experience domain score (range 0-20) is calculated by summing 5 items : I feel fatigued, I feel weak all over, I feel listless (“washed out”), I feel tired, and I have energy, while FACIT-F impact domain score (range 0-32) is calculated by summing the remaining 8 items. All responses are added with equal weight to obtain the total score. Higher scores represent better (less) fatigue experience.|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.||Units on a scale||Standard Error|Least Squares Mean
659610|NCT01877668|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Total Score|FACIT-F is a 13-item questionnaire, with each item scored on a 5-point scale ranging from 0 (not at all) to 4 (very much). Three endpoints are derived: change in FACIT-F total score, change in FACIT-F experience domain score, and change in FACIT-F impact domain score. FACIT-F total score (range 0 to 52) is calculated by summing the 13 items. FACIT-F experience domain score (range 0-20) is calculated by summing 5 items : I feel fatigued, I feel weak all over, I feel listless (“washed out”), I feel tired, and I have energy, while FACIT-F impact domain score (range 0-32) is calculated by summing the remaining 8 items. All responses are added with equal weight to obtain the total score. Higher scores represent better fatigue status.|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.||Units on a scale||Standard Error|Least Squares Mean
659611|NCT01877668|Secondary|Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Patient's Health State Today|The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems [1], some or moderate problems [2], or extreme problems [3]) within a particular EQ-5D dimension. Standard vertical 0 (worst imaginable health state) to 100 mm (best imaginable health state) visual analogue scale (similar to a thermometer) for recording an individual’s rating for their current health-related quality of life state; higher scores indicate a better health state, with a higher value representing better health status.|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.||mm||Standard Error|Least Squares Mean
659612|NCT01877668|Secondary|Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Anxiety/Depression|The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems [1], some or moderate problems [2], or extreme problems [3]) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm visual analogue scale (similar to a thermometer) for recording an individual’s rating for their current health-related quality of life state, with a higher value representing better health status.|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.||Units on a scale||Standard Error|Least Squares Mean
659613|NCT01877668|Secondary|Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Pain/Discomfort|The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems [1], some or moderate problems [2], or extreme problems [3]) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm visual analogue scale (similar to a thermometer) for recording an individual’s rating for their current health-related quality of life state, with a higher value representing better health status.|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit||Units on a scale||Standard Error|Least Squares Mean
659614|NCT01877668|Secondary|Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Usual Activities|The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems [1], some or moderate problems [2], or extreme problems [3]) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm visual analogue scale (similar to a thermometer) for recording an individual’s rating for their current health-related quality of life state, with a higher value representing better health status.|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.||Units on a scale||Standard Error|Least Squares Mean
659615|NCT01877668|Secondary|Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Self-care|The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems [1], some or moderate problems [2], or extreme problems [3]) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm visual analogue scale (similar to a thermometer) for recording an individual’s rating for their current health-related quality of life state, with a higher value representing better health status.|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.||Units on a scale||Standard Error|Least Squares Mean
659616|NCT01877668|Secondary|Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Mobility|The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems [1], some or moderate problems [2], or extreme problems [3]) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm visual analogue scale (similar to a thermometer) for recording an individual’s rating for their current health-related quality of life state, with a higher value representing better health status.|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.||Units on a scale||Standard Error|Least Squares Mean
659617|NCT01877668|Secondary|Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Mental Health Domain|The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher mental health domain score represents better mental health functioning.|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.||Units on a scale||Standard Error|Least Squares Mean
659618|NCT01877668|Secondary|Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Emotional Domain|The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher role-emotional domain score represents better role-emotional functioning.|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.||Units on a scale||Standard Error|Least Squares Mean
659619|NCT01877668|Secondary|Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Social Functioning Domain|The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher social functioning domain score represents better social functioning.|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number pf participants evaluable at each visit.||Units on a scale||Standard Error|Least Squares Mean
659620|NCT01877668|Secondary|Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Vitality Domain|The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher vitality domain score represents better vitality.|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.||Units on a scale||Standard Error|Least Squares Mean
659690|NCT01876784|Secondary|Evaluation of the Pharmacokinetics of Vandetanib in the Patient Population by Assessment of V/F.|Estimated time frame up to 155 progression events have occurred or up to individual progression of patient.|Blood sampling at 4-6 hours post-dose at Weeks 1, 2, 4, 8, 12 and then every 12 weeks thereafter until discontinuation.||||||
659621|NCT01877668|Secondary|Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: General Health Domain|The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher general health domain score represents better general health perceptions.|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.||Units on a scale||Standard Error|Least Squares Mean
659622|NCT01877668|Secondary|Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Bodily Pain Domain|The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher bodily pain domain score represents less bodily pain.|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.||Units on a scale||Standard Error|Least Squares Mean
659623|NCT01877668|Secondary|Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Physical Domain|The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher role-physical domain score represents better role-physical functioning.|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.||Units on a scale||Standard Error|Least Squares Mean
659624|NCT01877668|Secondary|Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Physical Functioning Domain|The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher physical functioning domain score represents better physical functioning.|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.||Units on a scale||Standard Error|Least Squares Mean
659625|NCT01877668|Secondary|Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute, Mental Component Summary Score|The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher MCS score represents better mental health status.|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.||Units on a scale||Standard Error|Least Squares Mean
659626|NCT01877668|Secondary|Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2) Acute, Physical Component Summary Score|The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the physical component summary (PCS) score and the mental component summary (MCS) score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a standard deviation (SD) of 10 points, and ranges from minus infinity to plus infinity. A higher PCS score represents better physical health status.|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.||Units on a scale||Standard Error|Least Squares Mean
659627|NCT01877668|Secondary|Change From Baseline in the Leeds Enthesitis Index (LEI)|Enthesitis is inflammation in the tendon, ligament, and joint capsule fiber insertion into bone. The LEI assesses enthesitis in 6 sites. Tenderness is recorded as either present (1) or absent (0) for each of the 6 sites, for an total score of 0–6. Higher score indicates a greater number of sites that are affected by enthesitis.|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug with baseline LEI>0 and were evaluable. n=number of participants evaluable at each visit.||Units on a scale||Standard Error|Least Squares Mean
659628|NCT01877668|Secondary|Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index|The SPARCC Enthesitis Index identifies the presence or absence of tenderness at 16 enthesial sites, including the bilateral Achilles tendons, plantar fascia insertion at the calcaneus, patellar tendon insertion at the base of the patella, quadriceps insertion into the superior border of the patella, supraspinatus insertion into the greater tuberosity of the humerus, and medial and lateral epicondyles. On examination, tenderness is recorded as present (1) or absent (0) for each of the 16 sites, with an overall total score ranging from 0 to 16. Higher score indicates a greater number of sites that are affected by enthesitis.|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug with baseline SPARCC Enthesitis Score>0 and were evaluable. n=number of participants evaluable at each visit.||Units on a scale||Standard Error|Least Squares Mean
659629|NCT01877668|Secondary|Change From Baseline in Dactylitis Severity Score (DSS)|Dactylitis is characterized by swelling of the entire finger or toe. The DSS is a function of finger circumference and tenderness, assessed and summed across all dactylitic digits. The severity of dactylitis is scored on a scale of 0–3, where 0=no tenderness and 3=extreme tenderness in each digit of the hands and feet. The range of total dactylitis scores for a patient is 0-60. Higher score indicates greater degree of tenderness.|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug with baseline DSS>0 and were evaluable. n=number of participants evaluable at each visit.||Units on a scale||Standard Error|Least Squares Mean
659630|NCT01877668|Secondary|Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Months 1, 3, 6, 9, and 12|PASI determines psoriasis severity based on lesion severity & percentage body surface area (BSA) affected. Lesion severity is assessed for erythema, induration, & scaling, evaluated separately for head & neck, upper limbs, trunk, & lower limbs & rated for each body area according to a 5 point scale: 0=no involvement; 1=slight; 2=moderate; 3=marked; 4=very marked. BSA involvement is the extent (%) of body area affected by psoriasis & is assigned a score: 0=no involvement; 1=0-9%; 2=10-29%; 3=30-49%; 4=50-69%; 5=70-89%; 6=90-100%. In each area, sum of severity rating scores is multiplied by the score representing the percentage of area involved by psoriasis, multiplied by a weighting factor (head 0.1; upper limbs 0.2; trunk 0.3; lower limbs 0.4). The sum of numbers obtained for the 4 body areas is the PASI score & can vary in increments of 0.1 & range from 0.0 to 72.0, higher scores represent greater severity of psoriasis. PASI75 is defined as a 75% reduction from baseline in PASI.|At Months 1, 3, 6, 9, and 12|All participants who were randomized and received at least 1 dose of study drug with PASI>0 and BSA ≥3% at baseline. n=number of responders.||Percentage of participants|||Number
659631|NCT01877668|Secondary|Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Response|The PGA-PsO is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are rated separately over the whole body according to a 5-point severity scale, scored as 0=none; 1, 2, 3, or 4=most severe. The severity rating scores are summed and the average taken; the total average is rounded to the nearest whole number score to determine a PGA-PsO score on a scale of 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe).|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug with baseline PGA-PsO>0 and were evaluable. n=number of participants evaluable at each visit.||Units on a scale||Standard Error|Least Squares Mean
659632|NCT01877668|Secondary|Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12|The PsARC covers 4 measures: Tender/painful joint count, swollen joint count, the Physician’s Global Assessment of Arthritis, and the Patient’s Global Assessment of Arthritis. The PsARC response is defined as improvement in 2 of 4 items, 1 of which must be joint pain or swelling, without worsening in any measure. Improvement criteria: ≥20% improvement in Physician’s Global Assessment of Arthritis; ≥20% improvement in Patient’s Global Assessment of Arthritis; ≥30% improvement in tender joint count; and ≥30% improvement in swollen joint count.|At Week 2 and Months 1, 2, 3, 4, 6, 9, and 12|All participants who were randomized and received at least 1 dose of study drug. n=number of responders.||Percentage of participants|||Number
659633|NCT01877668|Secondary|Change From Baseline in American College of Rheumatology Response Criteria Components Score: Tender/Painful Joint Count|Tender/painful joint counts are considered the most specific quantitative clinical measure used to assess the status of participants with inflammatory types of arthritis. Sixty eight (68) joints were assessed by a blinded assessor to determine the number of joints that were considered tender or painful.|From Baseline to end of Month 3|All participants who were randomized, received at least 1 dose of study drug and were evaluable.||Joints||Standard Error|Least Squares Mean
659634|NCT01877668|Secondary|Change From Baseline in American College of Rheumatology Response Criteria Components Score: Swollen Joint Count|Swollen joint counts are considered the most specific quantitative clinical measure used to assess the status of participants with inflammatory types of arthritis. Sixty six (66) joints were assessed by a blinded assessor to determine the number of joints that were considered swelling.|From Baseline to end of Month 3|All participants who were randomized, received at least 1 dose of study drug and were evaluable.||Joints||Standard Error|Least Squares Mean
659635|NCT01877668|Secondary|Change From Baseline in American College of Rheumatology Response Criteria Components Score: Physician's Global Assessment of Arthritis|The blinded investigator or qualified assessor assessed how the participant’s overall arthritis appeared at the time of the visit. This was an evaluation based on the participant’s disease signs, functional capacity and physical examination, and was independent of the Patient’s Global Assessment of Arthritis. The investigator’s response was recorded using a 100 mm VAS by placing a mark on the scale between 0 (very good) and 100 (very poor).|From Baseline to end of Month 3|All participants who were randomized, received at least 1 dose of study drug and were evaluable.||mm||Standard Error|Least Squares Mean
659636|NCT01877668|Secondary|Change From Baseline in American College of Rheumatology Response Criteria Components Score: Patient's Global Assessment of Arthritis|Participant answered the following question, “Considering all the ways your arthritis affects you, how are you feeling today?” The participant's response was recorded using a 100 mm VAS by placing a mark on the scale between 0 (very well) and 100 (very poorly).|From Baseline to end of Month 3|All participants who were randomized, received at least 1 dose of study drug and were evaluable.||mm||Standard Error|Least Squares Mean
659637|NCT01877668|Secondary|Change From Baseline in American College of Rheumatology Response Criteria Components Score: Patient's Assessment of Arthritis Pain|Participants assessed the severity of their arthritis pain using a 100-mm visual analog scale (VAS) by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.|From Baseline to end of Month 3|All participants who were randomized, received at least 1 dose of study drug and were evaluable.||mm||Standard Error|Least Squares Mean
659638|NCT01877668|Secondary|Change From Baseline in American College of Rheumatology Response Criteria Components: C-reactive Protein Levels|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|From Baseline to end of Month 3|All participants who were randomized, received at least 1 dose of study drug and were evaluable.||mg/L||Standard Error|Least Squares Mean
659639|NCT01877668|Secondary|Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score|The HAQ-DI assesses the difficulty a participant has had in the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2-3 items. For each question, level of difficulty is scored from 0 to 3 with 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. The score for each domain is the maximum (worst) score from the items/questions within the domain. Higher score indicates greater disability.|From Baseline to Week 2 and Months 1, 2, 4, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.||Units on a scale||Standard Error|Least Squares Mean
659640|NCT01877668|Secondary|Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12|ACR20 was calculated as a ≥20% improvement from baseline in tender/painful and swollen joint counts and ≥20% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, HAQ-DI, and CRP.|At Week 2 and Months 1, 2, 4, 6, 9, and 12|All participants who were randomized and received at least 1 dose of study drug. n=number of responders.||Percentage of participants|||Number
659641|NCT01877668|Secondary|Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12|ACR70 was calculated as a ≥70% improvement from baseline in tender/painful and swollen joint counts and ≥70% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, HAQ-DI, and CRP.|At Week 2 and Months 1, 2, 3, 4, 6, 9, and 12|All participants who were randomized and received at least 1 dose of study drug. n=number of responders.||Percentage of participants|||Number
659642|NCT01877668|Secondary|Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12|ACR50 was calculated as a ≥50% improvement from baseline in tender/painful and swollen joint counts and ≥50% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, HAQ-DI, and CRP.|At Week 2 and Months 1, 2, 3, 4, 6, 9, and 12|All participants who were randomized and received at least 1 dose of study drug. n=number of responders.||Percentage of participants|||Number
659643|NCT01877668|Secondary|Percentage of Participants With Progressed Modified Total Sharp Score (mTSS) at Month 12|Assessment of joint damage includes a joint erosion score (range 0-320) and a JSN score (range 0-208). The mTSS is the sum of the erosion and JSN scores (range 0-528). A higher score indicates more severe disease status. If a component score is missing, the mTSS will be missing. Progressor is defined as an increase in mTSS >0.5 from baseline.|At Month 12|All participants who were randomized, received at least 1 dose of study drug and were evaluable.||Percentage of participants|||Number
659644|NCT01877668|Secondary|Change From Baseline in the Van Der Heijdel Modified Total Sharp Score (mTSS) for Psoriatic Arthritis|Assessment of joint damage includes a joint erosion score (range 0-320) and a joint space narrowing (JSN) score (range 0-208). The mTSS is the sum of the erosion and JSN scores (range 0-528). A higher score indicates more severe disease status. If a component score is missing, the mTSS will be missing.|From Baseline to Month 12|All participants who were randomized, received at least 1 dose of study drug and were evaluable.||Units on a scale||Standard Error|Least Squares Mean
659645|NCT01877668|Primary|Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score|The HAQ-DI assesses the difficulty a participant has had in the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2-3 items. For each question, level of difficulty is scored from 0 to 3 with 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. The score for each domain is the maximum (worst) score from the items/questions within the domain. Higher score indicates greater disability.|From Baseline to Month 3|All participants who were randomized, received at least 1 dose of study drug and were evaluable.||Units on a scale||Standard Error|Least Squares Mean
659646|NCT01877668|Primary|Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20): Month 3|ACR20 was calculated as a ≥20% improvement from baseline in tender/painful and swollen joint counts and ≥20% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, health assessment questionnaire - disability index (HAQ-DI), and C-reactive protein (CRP).|At end of Month 3|All participants who were randomized and received at least 1 dose of study drug.||Percentage or participants|||Number
659647|NCT01877538|Primary|Standard Uptake Value (SUV) of [11C]Donepezil - BASELINE|"SUV values were calculated in 7 internal organs. SUV is a unitless ratio. We normalised to injected dose and bodyweight.
SUV (organ) = activity concentration (organ; kBq/mL) * bodyweight (mL) / injected dose (kBq)
Note: it is a common assumption when calculating SUV values that bodyweight equals volume, and therefore the unit mL is appropriate."|1 day (one timepoint)|In 6 subjects the SUV values in internal organs were calculated.||Unitless ratio||Standard Deviation|Mean
659648|NCT01877538|Primary|Distribution Volume (DV) of [11C]Donepezil - BASELINE|Logan's graphical analysis is used to calculate Distribution Volumes in Volumes of interest in internal organs (salivary gland, heart, liver, stomach, intestines, kidneys). Arterial blood sampling with radio metabolite correction is performed.|1 day (One timepoint)|In 6 subjects we analysed Volumes of distribution (Vd) and SUV values in internal organs (parotid, submandibular, spleen, stomach, heart, intestine, pancreas). NOTE: In subject number 7 we examined radioactive dose in 23 target organs (dose: microSv/MBq) and calculated the combined effective dose. The Vd and SUV values listed are from 6 subjects.||mL||Standard Deviation|Mean
659649|NCT01877421|Secondary|Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a|Proof of concept of KSL-W in reducing plaque as measured by percent of bleeding sites upon probing (BOP) in phase 2a.|days 0, 14, 28, 34|||Percent of bleeding sites||Standard Deviation|Mean
659691|NCT01876784|Secondary|Determination of the Efficacy of Vandetanib When Compared to Placebo in the Patient Population as Assessed by Efficacy Variables Including Overall Survival|Once 155 progression events have occurred when 25% of randomized patients have died due to any cause.|Estimated time frame at 20 months after initial 25.5 months.||||||
659650|NCT01877421|Secondary|Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a|"Data summarizes gingival index scores changes from baseline in phase 2a. Gingivitis will be assessed using both the MGI (Modified Gingival Index) and the Gingival Bleeding Index (BOP) The Modified Gingival Index assesses the buccal and lingual gingivae and interdental papillae.
Modified Gingival Index Scores:
0 Absence of inflammation
Mild inflammation; slight change in color, little change in texture of any portion of but not the entire marginal or papillary gingival unit
Mild inflammation; criteria as above but involving the entire marginal or papillary gingival unit
Moderate inflammation; glazing, redness, edema and/or hypertrophy of the marginal or papillary gingival unit
Severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration."|days 14, 28, 34|||scores on a scale||Standard Deviation|Mean
659651|NCT01877421|Secondary|Proof of Concept of KSL-W in Reducing Plaque in Phase 2a|"Data summarizes plaque index scores changes from baseline. Supragingival plaque will be assessed after the MGI and BOP assessments and following use of a disclosing solution on the facial (buccal) and lingual surfaces of a minimum of 16 scorable teeth according to the criteria of the Turesky modification of the Quigley-Hein Plaque Index.
Quigley-Hein Plaque Index Scores with Turesky Modifications:
0 No plaque
Separate flecks of plaque at the cervical margin of the tooth
A thin continuous band of plaque (up to one mm) at the cervical margin of the tooth
A band of plaque wider than one mm but covering less than one-third of the crown of the tooth
Plaque covering at least one-third but less than two thirds of the crown of the tooth
Plaque covering two-thirds or more of the crown of the tooth"|days 14, 28, 34|||scores on a scale||Standard Deviation|Mean
659652|NCT01877421|Primary|Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs)|Occurrence of local oral mucosal reactions, systemic reactions such as fever, nausea, headache, and changes in blood pressure, clinical laboratory measures of safety, and serious total body reactions will be assessed (AEs and SAEs)|Up to 28 days|||Participants|||Count of Participants
659653|NCT01877408|Other Pre-specified|Number of Participants With Adverse Events|Number of participants with intraoperative and post-operative adverse events, such as bleeding, hematoma, and infection|1 year|||participants|||Number
659654|NCT01877408|Secondary|Cosmetic Result|Cosmetic result evaluated by classification of scar line as regular (straight without any irregularity), irregular (not completely straight), or scalloped (with a wavy appearance)|Within 6 weeks after surgery|||participants|||Number
659655|NCT01877408|Secondary|Overall Patient Satisfaction|"Patient satisfaction evaluated with questionnaire using satisfaction scale
Very satisfied
Satisfied
Not satisfied"|Within 6 weeks after surgery|||participants|||Number
659656|NCT01877408|Secondary|Pain Experienced|Pain experienced during and after the procedure evaluated using a 10 point pain scale (0 signifies no pain and 10 signifies maximal pain|Within 2 days after surgery|||units on a 10-point pain scale||Standard Deviation|Mean
659657|NCT01877408|Secondary|Number of Participants With Complete Wound Healing by Post-Surgery Week 4||Within 4 weeks after surgery|||participants|||Number
659658|NCT01877408|Secondary|Difficulty in Learning and Performing Technique|"Evaluated by doctor survey based on 5 point Likert scale
Unicirc is much easier
Unicirc is easier
Neutral
Open surgical is easier
Open surgical is much easier"|1 year|The four physicians that participated in this study performed both procedures (i.e. open surgical and Unicirc) on study participants. Three physicians had significant previous (non-study) experience performing open surgical circumcisions. All four had no to very limited previous experience performing Unicirc circumcisions.||units on Likert scale||Full Range|Median
659659|NCT01877408|Primary|Intraoperative Duration|Amount of time from first manipulation of tissue under local anesthesia to dressing|1 hour|||minutes||Inter-Quartile Range|Median
659660|NCT01877343|Primary|Pulse Strength|Continuous change of pulse strength from baseline through the end of the study. Pulse strength is measured as volts by the system. Changes in pulse strength will be plotted against the four tilt table positions. Four positions will be explored, Mounting position, baseline, passive leg raise (cardiac preload dependent) and orthostasis head raise (cardiac afterload dependent). Patients go from mounting position, to baseline, to the corresponding position (passive leg raise or orthostasis head raise) and back to baseline. The assessment will take 30 minutes. Cardiac function curves will be constructed with the data collected and average pulse strength from baseline to 30 minutes will be reported.|Average pulse strength from baseline to 30 minutes|The study was terminated and the data was not sent to the contract company to analyze. The software package to compile the data is not available to the University of Florida.|||||
659661|NCT01877343|Primary|Pulse Rate|Continuous change of pulse rate from baseline through the end of the study will be followed. Changes in pulse rate will be plotted against the four tilt table positions. Four positions will be explored, Mounting position, baseline, passive leg raise (cardiac preload dependent) and orthostasis head raise (cardiac afterload dependent). Patients go from mounting position, to baseline, to the corresponding position (passive leg raise or orthostasis head raise) and back to baseline. The assessment will take 30 minutes. From the graph, average pulse rate is calculated.|Average pulse rate from baseline to 30 minutes|The study was terminated and the data was not sent to the contract company to analyze. The software package to compile the data is not available to the University of Florida.|||||
659662|NCT01877278|Primary|Changes From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at Week 4|"Multi-item questionnaire used to assess pain, stiffness, and physical function in patients with knee osteoarthritis.
The WOMAC consists of 24 items divided into 3 subscales:
Pain (5 items), Stiffness (2 items) and Physical Function (17 items). Score Range: On the Likert Scale version, the scores are summed for items in each subscale, with possible ranges as follows: pain=0-50, stiffness=0-20, physical function=0-170. A total WOMAC score is created by summing the items for all three subscales. A higher score represents a worse outcome."|baseline and 4 weeks|||units on a scale||Standard Deviation|Mean
659663|NCT01877278|Primary|Change From Baseline in Pain Perception Measured on Visual Analog Score (VAS) at Week 4|visual analogue scale (VAS) is a validated self report instrument assessing self report pain intensity Possible scores ranges:from 0 (no pain) to 100 (the maximum of pain)|baseline and 4 weeks|||units on a scale||Standard Deviation|Mean
659692|NCT01876784|Secondary|Determination of the Efficacy of Vandetanib When Compared to Placebo in the Patient Population as Assessed by Efficacy Variables Including Change in Tumour Size|Once 155 progression events have occurred.|Assessed tumour size at screening, Weeks 7, 8 and then every 12 weeks thereafter and at Discontinuation visit, estimated time frame at 25.5 months.||||||
659664|NCT01877161|Primary|The Change of Reaction Time Between Before and After Stimulation in Each Session (MTG, STG, Sham)|"Reaction time for lexical and repetition test were measured before and after the TMS stimulation at each sessions (at session 1, session 2, session 3 over MTG/STG/Sham; MTG: middle temporal gyrus, STG: superior temporal gyrus).
Response times were measured via the response pad, and spoken responses were recorded via a SV-1 Voice Key apparatus.
The reaction time post TMS - reaction time pre TMS were used for analysis.* Arm/Group Title Arm/Group Description Maximum length (999) Repetitive magnetic stimulation (rTMS) were applied over STG"|change between before and after the TMS stimulation for each sessions (at session 1, session 2, session 3)|||msec||Standard Deviation|Mean
659665|NCT01877148|Other Pre-specified|Change From Jebsen-Taylor Hand Function Test - Jebsen Test|The Jebsen-Taylor Hand Function Test assesses a broad range of uni-manual hand functions required for activities of daily living. Seven subtests are performed on both non-dominant and dominant hand: 1. Writing a 24-letter, 3rd grade reading difficulty sentence 2... Total score = sum of times for each subtests. Shorted times are indicative of better hand function|At baseline, after 1 month|||minutes||Standard Error|Mean
659666|NCT01877148|Other Pre-specified|Change From Parkinson Disease Quality of Life - PDQL|"Parkinson disease quality of life is the sum of 37 questions, total score ranging from 0 (best possible outcome) to 185 (worst possible outcome), as accurate and appropriate"|at baseline, after 1 month|||units on a scale||Standard Error|Mean
659667|NCT01877148|Secondary|Change From Cortical Excitability Via Single Transcranial Magnetic Stimulation||per sesssion: at baseline and after physical therapy|||milivolt||Standard Error|Mean
659668|NCT01877148|Primary|Change From Unified Parkinson´s Disease Rating Scale - UPDRS|"Unified Parkinson´s Disease Rating Scale is the sum of 27 questions, total score ranging from108 (best possible outcome) to 0 (worst possible outcome), as accurate and appropriate"|At baseline, after 1 month|||units on a scale||Standard Error|Mean
659669|NCT01876992|Other Pre-specified|Effect of Dose Escalation|Compare the effect of dose escalation of metformin on CBP phosphorylation in white blood cells in both in vivo and ex vivo assays to subsequent physiological changes in vivo for adults and children. CBP phosphorylation will be measured by western blot analysis using a probe that is specific for the phosphorylated CBP protein. The outcome will be the % difference between the patient before starting metformin and at each dose increment.|Approximately Week 10|Escalating CBP phosphorylation was measured.||percent phosphorylation||Full Range|Mean
659670|NCT01876992|Secondary|Fasting Blood Glucose.|A fasting blood sugar level less than 100 mg/dL is normal. A fasting blood sugar level from 100 to 125 mg/dL is considered prediabetes. If a subject has a blood sugar of 126 mg/dL or higher on two separate tests, they are diagnosed with diabetes. Metformin decreases fasting blood sugar.|30 days|Data were not collected for this outcome measure.|||||
659671|NCT01876992|Secondary|Change in BMI|The BMI is an index measure of body weight and is used to define states of obesity. Height ( in meters) and weight (in Kilograms) are used to calculate a BMI (kg/m2).|Baseline and after about 30 days|||change in BMI (kg/m2)||Full Range|Mean
659672|NCT01876992|Primary|% Cyclic Amine Mono Phosphate (cAMP) Response Element Binding Protein (CBP) White Blood Cell (WBC) Phosphorylation (Metformin Treated vs no Treatment)|To assess metformin-induced Cyclic Amine Mono Phosphate (cAMP) response element binding protein (CBP) phosphorylation in circulating white blood cells both in vivo and ex vivo and determine its relationship to subsequent changes in body mass index, fasting blood glucose.|10 weeks|||percent phosphorylation||Full Range|Mean
659673|NCT01876979|Primary|Time|Time duration for the application of device, in minutes.|Time duration of placement of device in operating room|||minutes||Full Range|Mean
659674|NCT01876823|Other Pre-specified|Conversion to Dementia Using Clinical Dementia Rating (CDR)|The CDR is a numeric rating scale that is used to quantify the severity of one's cognitive function. The scale goes from 0=normal; 0.5=mild cognitive impairment; 1 to 3=mild to moderate/severe dementia. CDR was used a dichotomous outcome measure (no=0; yes=1).|Baseline, Week 48|Analysis was intent to treat; ANOVA repeated measures. All values of data collected were included, except for those who exited the study early. In these cases, their last observation was carried forward (LOC).||participants|||Number
659675|NCT01876823|Other Pre-specified|Change in Clinical Global Impression - Cognitive Change|The CGI Cognitive Change follows a seven-point likert scale. Compared to the patient's condition at baseline in the study [prior to medication initiation], the patient's condition is rated as: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment. Responses from the entire group were calculated. Mean at final visit and baseline is reported below.|Baseline, Week 48|Analysis was intent to treat; ANOVA repeated measures. All values of data collected were included, except for those who exited the study early. In these cases, their last observation was carried forward (LOC).||units on a scale||Standard Deviation|Mean
659676|NCT01876823|Other Pre-specified|Change in Clinical Global Impression - Depression Change|The CGI Depression Change follows a seven-point likert scale. Compared to the patient's condition at baseline in the study [prior to medication initiation], the patient's condition is rated as: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment. Responses were calculated for the entire group. Mean at final visit has been reported below. Higher mean at baseline indicates a decrease in depression scores.|Baseline, Week 48|Analysis was intent to treat; ANOVA repeated measures. All values of data collected were included, except for those who exited the study early. In these cases, their last observation was carried forward (LOC).||units on a scale||Standard Deviation|Mean
659677|NCT01876823|Other Pre-specified|Change in Treatment Emergent Side Effects (TESS)|"Somatic side effect rating scale which includes 26 common somatic side effects associated with previous medication clinical trials; rated by the study physician. Factors were dichotomized to yes or no responses on this scale, which equated to the symptom being either present or not present. Yes and no responses were given a value of 0 (no) or 1 (yes). Responses from the entire group were calculated and the mean at baseline and the last visit is reported below."|Baseline, Week 48|Analysis was intent to treat.||units on a scale||Standard Deviation|Mean
659742|NCT01875783|Secondary|Rates of Retinal Treatment Over 1 Year for Patients With DME|Percentage of participants who are referred by OCT guided algorithm to a retina specialist who receive treatment for DME over the course of 1 year follow-up by retina specialist|1 year||||||
659678|NCT01876823|Other Pre-specified|Change in 24-item HAMD|Change in 24-item Hamilton Rating Scale for Depression (HAMD) scores from baseline to Week 48: HAMD measures depression severity based on a series of 24 items items. The range of HAMD total score is 0-74; 0 indicates no depressive symptoms and a maximum HAMD score is a 74, where the greater the score indicates more significant psychopathology. In this study, moderate to severe depression is considered a HAMD-24 greater than 14.|Baseline, Week 48|Analysis was intent to treat.||scores on a scale||Standard Deviation|Mean
659679|NCT01876823|Secondary|Change in Trails A|Change in Trails A scores from baseline to Week 48: Measures attention and executive function. It asks patients to connect numbers from 1-25 in numerical order as fast as they can. Patients are timed; the longer it takes for the patient to connect the numbers, the worse their score. Unit of measure is in seconds. The amount of errors that the patient makes during trails is also recorded.|Baseline, Week 48|Analysis was intent to treat.||seconds||Standard Deviation|Mean
659680|NCT01876823|Secondary|Change in Trails B|Change from baseline to Week 48 on Trails B: Measures attention and executive function. It asks patients to connect numbers and letters in numerical to alphabetical order from (1-13 and A-L) as fast as they can. Patients are timed; the longer it takes for the patient to connect the numbers and letters, the worse their score. Unit of measure is in seconds. The amount of errors that the patient makes during trails is also recorded.|Baseline, Week 48|Analysis was intent to treat.||seconds||Standard Deviation|Mean
659681|NCT01876823|Secondary|Change in Selective Reminding Test - Delayed Recall (SRT-DR)|Change in Selective Reminding Test-Delayed Recall scores from baseline to Week 48: SRT Delay is administered 15 minutes after the immediate recall portion. Patients are asked to remember as many of the words as they can from the 6 trials. Maximum raw score is a 12 for free recall. If a patient is unable to recall a word, they are given a chance to recognize it among three incorrect word choices. Maximum raw score for recognition is 12. The greater the score on the delayed recall portion, the better the patient does on the assessment.|Baseline, Week 48|Analysis was intent to treat.||units on a scale||Standard Deviation|Mean
659682|NCT01876823|Secondary|Change in Wechsler Memory Scale-III (WMS-III)|Change in Wechsler Memory Scale-III scores from baseline to Week 48: The WMS-III Visual Reproduction sub-test was used to measure visual working memory and delayed memory. Patients were shown pictures of four drawings and were asked to reproduce them from memory immediately after seeing them, and 25 minutes after seeing them. The four scores are summed and the greater the total raw score, the better the patient did on the assessment. The maximum raw score for this test is a 41 on both the immediate and delayed portions (the overall range is 0-82 points). The change score is calculated using the total scores of both the immediate and delayed portions.|Baseline, Week 48|Analysis was intent to treat.||units on a scale||Standard Deviation|Mean
659683|NCT01876823|Primary|Change in Selective Reminding Test - Total Immediate Recall (SRT-IR)|Change in Selective Reminding Test-Total Immediate Recall (SRT-IR) scores from baseline to Week 48: Measures word recall (maximum 12 words per trial, across 6 trials). Maximum total recall score across 6 trials is 72; minimum recall is 0 across 6 trials. The higher the raw score, the better the patient did at recalling the target words. The unit of measure is the raw score, or the sum of the number of words recalled across all 6 trials.|baseline, 48 weeks|Analysis was intent to treat.||units on a scale||Standard Deviation|Mean
659684|NCT01876810|Other Pre-specified|Cue- Reactivity Visual Analogue Scale for Craving After 1 Week of Treatment|In this study, each session started with participants taking four puffs of their preferred-brand cigarette to standardize the time from last nicotine exposure. Participants were then seated in a comfortable chair and completed the baseline Visual Analogue Scale for craving 0-100 mm (The higher the number the more is the craving). The smoking cue was a pack of cigarettes and a lighter. Participants were instructed to light the cigarette without puffing and hold it for 30 sec while the physiological recordings were measured. Then the participant was asked to extinguish the cigarette. The neutral cue was an unsharpened pencil, a notepad, and a sharpener. Participants were instructed to sharpen the pencil and hold it as if writing for 30 sec. Participants completed the Visual Analogue Scale for craving during the cue, and 15 and 30 min after cue presentation.|during the lab Cue- reactivity paradigm after 1 week of treatment|participants self-reportd Visual analogue scale (0-100 mm) for craving at the time of presenting the smoking cue. The higher the number on the scale, the more is the craving||units on a scale: from 0-100 mm||Standard Error|Mean
659685|NCT01876810|Secondary|The Percentage of Choice of Nicotinized Cigarettes After 1 Week of Treatment|"Percentage of choice of Nicotinized cigarettes was calculated for each participant during the lab session which took place after 1 week of treatment.
Each session started with participants taking four puffs of their preferred-brand cigarette to standardize the time from last nicotine exposure. Participants were asked to complete some questionnaires at baseline. Then, they were asked to relax for 30 min listening to music or reading. Four exposure trials followed that were separated by 30 min of relaxation. In each exposure trial, participants took four puffs of a Nicotinized (A) or Denicotinized (less than 0.05 mg nicotine.) (B) cigarette in the order of ABAB or BABA. Cigarettes were color-coded. Participants then began four choice trials separated by 30 min of relaxation. In each trial, participants chose any combination of 4 puffs from the two cigarettes."|during the lab forced choice paradigm after 1 week of treatment|||percentage of choice of nicotinized ciga||Standard Error|Mean
659686|NCT01876810|Primary|Number of Days With Self-report of No Smoking and Breath Carbon Monoxide of <5 PPM During Quit-attempt Weeks|the number of days of no smoking was calculated for each participant. Abstinence was verified by daily Self-reports of no smoking and breath carbon monoxide < 5 ppm|1 week in each phase|||days||Standard Error|Mean
659687|NCT01876784|Secondary|Evaluation of the Pharmacokinetics of Vandetanib in the Patient Population by Assessment of CL/F|Estimated time frame up to 155 progression events have occurred or up to individual progression of patient.|Blood sampling at 4-6 hours post-dose at Weeks 1, 2, 4, 8, 12 and then every 12 weeks thereafter until discontinuation.||||||
659688|NCT01876784|Secondary|Evaluation of the Pharmacokinetics of Vandetanib in the Patient Population by Assessment of AUCss|Estimated time frame up to 155 progression events have occurred or up to individual progression of patient.|Blood sampling at 4-6 hours post-dose at Weeks 1, 2, 4, 8, 12 and then every 12 weeks thereafter until discontinuation.||||||
659689|NCT01876784|Secondary|Evaluation of the Pharmacokinetics of Vandetanib in the Patient Population by Assessment of Cmax|Estimated time frame up to 155 progression events have occurred or up to individual progression of patient.|Blood sampling at 4-6 hours post-dose at Weeks 1, 2, 4, 8, 12 and then every 12 weeks thereafter until discontinuation.||||||
659693|NCT01876784|Secondary|Determination of the Efficacy of Vandetanib When Compared to Placebo in the Patient Population as Assessed by Efficacy Variables Including Objective Response Rate.|Once 155 progression events have occurred.|Estimated time frame up to 25.5 months (18 months recruitment period plus 7.5 months follow up). RECIST measurements taken every 12 weeks from randomization||||||
659694|NCT01876784|Secondary|Evaluation of the Safety and Tolerability of Vandetanib Treatment in the Patient Population by Assessment of Adverse Events, Vital Signs, Laboratory Parameters and Electrocardiography.|Once 155 progression events have occurred.|Safety assessments at baseline, Weeks 1, 2, 4, 8, 12 and then every 12 weeks thereafter||||||
659695|NCT01876784|Secondary|Demonstration of an Improvement in Time to Worsening of Pain in Patients Treated With Vandetanib When Compared to Placebo in the Patient Population.|Once 155 progression events have occurred.|Patient assessments at baseline, week 4, 8, 12 and then every 12 weeks thereafter, assess up to 25.5 months||||||
659696|NCT01876784|Secondary|Determination of the Efficacy of Vandetanib When Compared to Placebo in the Patient Population as Assessed by Efficacy Variables Including Duration of Response.|Once 155 progression events have occurred.|Estimated time frame up to 25.5 months (18 months recruitment period plus 7.5 months follow up). RECIST measurements taken every 12 weeks from randomization||||||
659697|NCT01876784|Primary|Progression-Free Survival (PFS)|The PFS was defined as the time (in months) from randomization until the date of first documented disease progression or death (from any cause), whichever came first. Disease progression as per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) was defined as: at least a 20% increase and absolute increase of 5 mm in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Analysis was performed by Kaplan-Meier method.|Randomization until disease progression or death, assessed every 12 weeks (up to 22 months)|Intent to treat population included all randomized participants.||months||95% Confidence Interval|Median
659698|NCT01876732|Secondary|Change in Quality of Life|The scoring procedure for the KDQOL-36 (Kidney Disease Quality of Life Instrument adopted for quality of life assessment of patients with kidney disease),first transforms the raw precoded numeric values of items to a 0-100 possible range with higher transformed scores reflecting a better quality of life. Each item is put on a 0 to100 range so that the lowest and highest possible scores are set at 0 and100, respectively. The results entered in the outcome data is the mean absolute difference between the mean pre-test score and the mean post-test score.|3 month|Subjects were asked to complete a KDQOL-36 (Kidney Disease Quality of Life Instrument adopted for quality of life assessment of patients with kidney disease), once prior to therapy, and then again at the end of 3 months when therapy (when therapy is completed), was completed. Pre and post results will be compared.||Scores on a Scale||Standard Deviation|Mean
659699|NCT01876732|Primary|Change in Amount of Epogen Required|The effects of Vitamin B12 supplementation on erythropoitin alpha (Epogen) requirements in HD patients|Baseline and 4 months|||unit/ml||Standard Deviation|Mean
659700|NCT01876706|Secondary|QMAX Median at Baseline and 12 Months With CI 95%|QMAX indicates the maximum flow rate during a Uroflow in mL/sec. QMAX is used as an indicator for the diagnosis of enlarged prostate. A lower QMAX may indicate that the enlarged prostate is obstructive.|12 Month|||mL/sec||95% Confidence Interval|Median
659701|NCT01876706|Secondary|IPSS at Baseline and 12 Months, Median , 95% CI|"The International Prostate Symptom Score (IPSS) is an 7 question written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH). Lower scores are indicative of less symptoms.
Score Correlation[1] 0-7 Mildly symptomatic 8-19 Moderately symptomatic 20-35 Severely symptomatic"|12 Month|||IPSS total score||95% Confidence Interval|Median
659702|NCT01876706|Secondary|BPHII Baseline and 12 Month Median Score, 95% CI|"BPH Impact Index (BPH II) A validated questionnaire to measure how much urinary problems of patients with benign prostatic hyperplasia affect domains of health. BPHII total score is the combined (sum) of scores for Questions 1-4 (sum range of 0-13 scoring is presented below) MAX of 13 would be 3,3,3,and 4: A score of zero = Patient experiences no BPH impact and does not add any to score.
Questions 1-4:
Over the past month how much physical discomfort did any urinary problems cause you? &
Over the past month, how much did you worry about your health because of any urinary problems? 0 None, 1, 2, 3 A lot.
Overall, how bothersome has any trouble with urination been during the past month? 0 Not at all bothersome,1,2,3 Bothers me a lot.
Over the past month, how much of the time has any urinary problems kept you from doing the kind of things you would usually do? 0 None of the time, 1,2,3, 4 All of the time."|12 Month|||BPHII total score||95% Confidence Interval|Median
659703|NCT01876706|Secondary|Pain Tolerability Throughout the UroLift System Procedure|Pain Tolerability using questionnaire pelvic pain Visual Analog Scale (VAS) 0-10. A score of 0 (zero) would equal no pain while a score of 10 would equate to pain as bad as patient could imagine. This scale was assessed at different times during procedure as specified in results section.|12 Month|Pain Tolerability throughout the UroLift System Procedure||units on a scale||Full Range|Mean
659704|NCT01876706|Secondary|QMAX 12 Month Percent (%) Change in mL/Sec From Baseline|QMAX indicates the maximum flow rate during a Uroflow in mL/sec. QMAX is used as an indicator for the diagnosis of enlarged prostate. A lower QMAX may indicate that the enlarged prostate puts pressure on the urethra. The larger Percent (%) Change of the QMAX value at 12 Month Follow-up from Baseline, demonstrate the improvement in QMAX. Note: Percent (%) Change: is the average %change of each subject|12 Months|QMAX maximum peak urinary flow rate, if valid void >125ml at baseline and 12 months. Urinary flow rate overread by independent reviewer. Note that n=33 pertains to those subjects where a valid void was received, therefore 8 subject flows were either not valid or were not received.||percentage||95% Confidence Interval|Mean
659705|NCT01876706|Secondary|QMAX 12 Month Change Minus Baseline|QMAX indicates the maximum flow rate during a Uroflow in mL/sec. QMAX is used as an indicator for the diagnosis of enlarged prostate. A lower QMAX may indicate that the enlarged prostate puts pressure on the urethra. The larger number for Change of the QMAX value at 12 Month Follow-up minus Baseline, demonstrate the improvement in QMAX|12 Months|QMAX maximum peak urinary flow rate, if valid void >125ml at baseline and 12 months. Urinary flow rate overread by independent reviewer. Note that n=33 pertains to those subjects where a valid void was received, therefore 8 subject flows were either not valid or were not received.||mL/sec||Standard Deviation|Mean
659706|NCT01876706|Secondary|Qmax Scores at Baseline and 12 Month Follow-up|QMAX indicates the maximum flow rate during a Uroflow in mL/sec. QMAX is used as an indicator for the diagnosis of enlarged prostate. A lower QMAX may indicate that the enlarged prostate puts pressure on the urethra.|12 Month|QMAX maximum peak urinary flow rate, if valid void >125ml at baseline and 12 months. Urinary flow rate overread by independent reviewer. Note that n=33 pertains to those subjects where a valid void was received, therefore 8 subject flows were either not valid or were not received.||mL/sec||Standard Deviation|Mean
659707|NCT01876706|Secondary|BPH II 12 Month Change From Baseline|"BPH Impact Index (BPH II) A validated questionnaire to measure how much urinary problems of patients with benign prostatic hyperplasia affect domains of health. BPHII total score is the combined (sum) of scores for Questions 1-4 (sum range of 0-13 scoring is presented below) MAX of 13 would be 3,3,3,and 4: A score of zero = Patient experiences no BPH impact and does not add any to score.
Questions 1-4:
Over the past month how much physical discomfort did any urinary problems cause you? &
Over the past month, how much did you worry about your health because of any urinary problems? 0 None, 1, 2, 3 A lot.
Overall, how bothersome has any trouble with urination been during the past month? 0 Not at all bothersome,1,2,3 Bothers me a lot.
Over the past month, how much of the time has any urinary problems kept you from doing the kind of things you would usually do? 0 None of the time, 1,2,3, 4 All of the time."|12 Months|||BPHII total score||Standard Deviation|Mean
659708|NCT01876706|Secondary|BPH II 12 Month Percent (%) Change From Baseline|"BPH Impact Index (BPH II) A validated questionnaire to measure how much urinary problems of patients with benign prostatic hyperplasia affect domains of health. BPHII total score is the combined (sum) of scores for Questions 1-4 (sum range of 0-13 scoring is presented below) MAX of 13 would be 3,3,3,and 4: A score of zero = Patient experiences no BPH impact and does not add any to score.
Questions 1-4:
Over the past month how much physical discomfort did any urinary problems cause you? &
Over the past month, how much did you worry about your health because of any urinary problems? 0 None, 1, 2, 3 A lot.
Overall, how bothersome has any trouble with urination been during the past month? 0 Not at all bothersome,1,2,3 Bothers me a lot.
Over the past month, how much of the time has any urinary problems kept you from doing the kind of things you would usually do? 0 None of the time, 1,2,3, 4 All of the time."|12 Months|||percentage||95% Confidence Interval|Mean
659709|NCT01876706|Secondary|BPH II Scores at Baseline and 12 Month Follow-up|"BPH Impact Index (BPH II) A validated questionnaire to measure how much urinary problems of patients with benign prostatic hyperplasia affect domains of health. BPHII total score is the combined (sum) of scores for Questions 1-4 (sum range of 0-13 scoring is presented below) MAX of 13 would be 3,3,3,and 4: A score of zero = Patient experiences no BPH impact and does not add any to score.
Questions 1-4:
Over the past month how much physical discomfort did any urinary problems cause you? &
Over the past month, how much did you worry about your health because of any urinary problems? 0 None, 1, 2, 3 A lot.
Overall, how bothersome has any trouble with urination been during the past month? 0 Not at all bothersome,1,2,3 Bothers me a lot.
Over the past month, how much of the time has any urinary problems kept you from doing the kind of things you would usually do? 0 None of the time, 1,2,3, 4 All of the time."|12 Month|||BPHII total score||Standard Deviation|Mean
659710|NCT01876706|Secondary|IPSS 12 Month Percent (%) Change From Baseline|"The International Prostate Symptom Score (IPSS) is an 7 question written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH) using a total score from 0 - 35.
The larger Percent (%) Change in IPSS Score at 12 Month Follow-up from Baseline, demonstrates the improvement in IPSS (the mean score was change by X %). Note: Percent (%) Change: is the mean % change of each subject."|12 Months|||percentage||95% Confidence Interval|Mean
659711|NCT01876706|Secondary|IPSS 12 Month Change From Baseline|"The International Prostate Symptom Score (IPSS) is an 7 question written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH) using a total score from 0 - 35.
The larger number for Change in IPSS Score 12 Month Follow-up from Baseline, demonstrate the improvement in IPSS."|12 Months|||Change in IPSS||Standard Deviation|Mean
659712|NCT01876706|Secondary|IPSS Scores at Baseline and 12 Month Follow-up|"The International Prostate Symptom Score (IPSS) is an 7 question written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH). Lower scores are indicative of less symptoms.
Score Correlation[1] 0-7 Mildly symptomatic 8-19 Moderately symptomatic 20-35 Severely symptomatic"|12 Months|||IPSS total score||Standard Deviation|Mean
659713|NCT01876706|Primary|Quality of Recovery|Primary effectiveness will be achieved when 80% (95% lower confidence limit) of subjects achieve a score of 80 or more on the Quality of Recovery Visual Analog Scale (QoR VAS) by the one month follow-up visit. The VAS scale is 0-100, with 100 being 100% recovery.|1 Month|||participants|||Number
659714|NCT01876368|Secondary|Number of Patients With Total Adverse Events, Serious Adverse Events and Death|Number of patients with total adverse events, serious adverse events and death were reported.|8 weeks|Safety Set (SAF) - All patients who received at least one dose of study medication in the double-blind epoch. Patients were analyzed according to the treatment they received. One patient was not included in the SAF due to mis-randomization.||Number of participants|||Number
659715|NCT01876368|Secondary|Number of Patients Achieving Successful Mean Sitting Diastolic Blood Pressure (msDBP) Response|Successful mean sitting diastolic blood pressure response is defined as msDBP <90 mmHg or a reduction ≥10 mmHg from baseline.|baseline, 8 weeks|Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS||Participants|||Number
659716|NCT01876368|Secondary|Number of Patients Achieving Successful Mean Sitting Systolic Blood Pressure (msSBP) Response|Successful mean sitting systolic blood pressure response is defined as msSBP <140 mmHg or a reduction ≥ 20 mmHg from baseline.|baseline, 8 weeks|Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS||Participants|||Number
659743|NCT01875783|Secondary|Rates of Retinal Treatment for Patients With DME|Percentage of participants are referred by OCT-guided algorithm who receive treatment or are scheduled for treatment for DME at first visit with retina specialist after study enrollment|One month||||||
659717|NCT01876368|Secondary|Number of Patients Achieving Successful Mean Sitting Diastolic Blood Pressure (msDBP) Control|Successful mean sitting diastolic blood pressure control is defined as msDBP <90 mmHg|8 weeks|Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS.||Participants|||Number
659718|NCT01876368|Secondary|Number of Patients Achieving Successful Mean Sitting Systolic Blood Pressure (msSBP) Control|Successful mean sitting systolic blood pressure control is defined as msSBP <140 mmHg|8 weeks|Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS.||Participants|||Number
659719|NCT01876368|Secondary|Number of Patients Achieving Successful Overall Blood Pressure Control|Successful overall blood pressure control is defined as both msSBP/msDBP <140/90 mmHg|8 weeks|Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS||Participants|||Number
659720|NCT01876368|Secondary|Change From Baseline in Office Pulse Pressure|Mean sitting pulse pressure (msPP) will be calculated at screening through end of study at every visit. Mean sitting pulse pressure is calculated as msSBP-msDBP.|baseline, 8 weeks|Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS.||mmHg||Standard Error|Least Squares Mean
659721|NCT01876368|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)|Sitting blood pressure (BP) measurement will be taken at every visit from screening through end of study. For each participant at each visit, four separate sitting BP measurements will be obtained (with a full two minute interval between measurements) and averaged to obtain the mean|baseline, 8 weeks|Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS.||mmHg||Standard Error|Least Squares Mean
659722|NCT01876368|Secondary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)|Sitting blood pressure (BP) measurement will be taken at every visit from screening through end of study. For each participant at each visit, four separate sitting BP measurements will be obtained (with a full two minute interval between measurements) and averaged to obtain the mean|baseline, 8 weeks|Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS.||mmHg||Standard Error|Least Squares Mean
659723|NCT01876368|Secondary|Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure (maDBP)|Twenty-four hour mean ambulatory blood pressure measurements (ABPM) will be performed at baseline and at end of study (week 8). The 24-hour ABPM measurements are performed beginning 24 hours prior to baseline and week 8 visits.|baseline, 8 weeks|A subset of randomized participants, who had ABPM measurements at both baseline and week 8, were included in the analysis.||mmHg||Standard Error|Least Squares Mean
659724|NCT01876368|Primary|Change From Baseline in 24-hour Mean Ambulatory Systolic Blood Pressure (maSBP)|Twenty-four hour mean ambulatory blood pressure measurements (ABPM) will be performed at baseline and at end of study (week 8). The first 24-hour ABPM will be performed beginning at 24 hours prior to baseline visit and the second will be performed 24 hours prior to week 8 visit.|baseline, 8 weeks|A subset of randomized participants, who had ABPM measurements at both baseline and week 8, were included in the analysis||mmHg||Standard Error|Least Squares Mean
659725|NCT01876329|Secondary|Presence of Anti-GPC Antibodies|Hypothesis: Evidence of anti-GPC Ab in a group of patients with RA will be more prevalent as compared to a group of patients with AITD and with no known systemic or organ specific autoimmune condition.|7 months|||participants|||Number
659726|NCT01876329|Primary|Prevalence of Vitamin B12 Deficiency|Hypothesis: Evidence of serum vitamin B12 deficiency, as measure by either a low vitamin B12 level or elevated methylmalonic acid, will be more common in RA patients with anti-GPC Ab.|7 months|||participants|||Number
659727|NCT01875991|Secondary|Strength of Preference for Autoinjector A and Autoinjector B|Strength of preference for Autoinjector A versus Autoinjector B was assessed by Question 2 of the Subject Preference Questionnaire administered after the completion of the two treatment periods at Week 8. After selecting which autoinjector they preferred overall, participants were asked to indicate how much they preferred it on a scale from 1 (Slightly), 2 (Somewhat), 3 (Strongly) and 4 (Vey Strongly).|Week 8|Primary Analysis Set||percentage of participants|||Number
659728|NCT01875991|Secondary|Pain Associated With Use of the Autoinjector|"Pain associated with use of the autoinjector was assessed based on responses to Question 10 of the Subject’s Experience with the Autoinjector Questionnaire: Using this scale, select the circle that best describes how much it hurt when giving yourself an injection. Participants answered on a scale from 0 (No hurt) to 5 (Hurts worst). The percentage of participants who scored a 0 (No hurt) or 1 (Hurts a little bit) is reported."|At the end of each treatment period; Week 4 and Week 8|Full analysis set with available data||percentage of participants|||Number
659729|NCT01875991|Secondary|Satisfaction|"Satisfaction was assessed based on responses to questions 11 and 12 of the Subject’s Experience with the Autoinjector Questionnaire. Question 11: How dependable (durable, sturdy, reliable) did you feel the autoinjector device was? answered on a scale from 1 (Not at all) to 5 (Very much). Question 12: Overall, how likely would you be to recommend the autoinjector to someone like you who is on etanercept? answered on a scale from 1 (Would not recommend) to 5 (Highly likely to recommend). The percentage of participants who scored either a 4 or 5 on each question is reported."|At the end of each treatment period; Week 4 and Week 8|Full analysis set with available data||percentage of participants|||Number
659730|NCT01875991|Secondary|Discomfort|"Discomfort was assessed based on responses to Question 9 of the Subject’s Experience with the Autoinjector Questionnaire: How much discomfort did you experience when giving yourself the medicine using the autoinjector? Participants answered on a scale from 1 (None) to 5 (Very much). The percentage of participants who scored a 1 (None) or 2 (A little) is reported."|At the end of each treatment period; Week 4 and Week 8|Full analysis set with available data||percentage of participants|||Number
659731|NCT01875991|Secondary|Convenience|"Convenience was assessed based on responses to Question 8 of the Subject’s Experience with the Autoinjector Questionnaire: How convenient was the autoinjector to use? Participants answered on a scale from 1 (Not at all) to 5 (Very much). The percentage of participants who scored a 4 (Quite a bit) or 5 (Very much) is reported."|At the end of each treatment period; Week 4 and Week 8|Full analysis set with available data||percentage of participants|||Number
659732|NCT01875991|Secondary|Certainty of Completing the Injection With the Autoinjector|"Certainty of completing the injection with the autoinjector was assessed based on responses to Question 7 of the Subject’s Experience with the Autoinjector Questionnaire: How certain were you that you knew when the injection was finished? Participants answered on a scale from 1 (Not at all) to 5 (Extremely). The percentage of participants who scored 4 (Very) or 5 (Extremely) is reported."|At the end of each treatment period; Week 4 and Week 8|Full analysis set with available data||percentage of participants|||Number
659733|NCT01875991|Secondary|Ease of Use|Ease of use was assessed based on responses to questions 1 to 6 of the Subject’s Experience with the Autoinjector Questionnaire: 1. How easy was it to learn how to use the autoinjector? 2. How easy was it for you to press the button to start the injection? 3. How easy was the autoinjector to use? 4. How easy was it to hold the autoinjector throughout the injection? 5. How easy was it for you to inject yourself using the autoinjector? 6. How easy was it to follow the progress of the injection? Each question was answered on a scale from 1 (Very difficult) to 5 (Very easy). The percentage of participants who scored either a 4 (Somewhat easy) or 5 (Very easy) on each question is reported.|At the end of each treatment period; Week 4 and Week 8|Full analysis set with available data||percentage of participants|||Number
659734|NCT01875991|Secondary|Change From Baseline in Needle Apprehension at Week 4|"Participants' needle apprehension was assessed using the Subject’s Perception of Self-Injecting Questionnaire. Participants answered the question Overall how nervous are you about the needle when you think about giving yourself etanercept using the autoinjector using a scale from 1 (extremely nervous) to 5 (not at all nervous)."|Baseline and Week 4|"Full analysis set, which included all randomized participants. n indicates the number of participants with available data."||units on a scale||Standard Deviation|Mean
659735|NCT01875991|Primary|Percentage of Participants With a Preference for Autoinjector A Versus Autoinjector B|"Preference for autoinjector A versus autoinjector B was assessed by Question 1 of the Subject Preference Questionnaire administered after the completion of the 2 treatment periods at Week 8. Participants answered the question Which autoinjector do you prefer overall?"|Week 8|The primary analysis set consisted of all randomized participants who received at least 1 injection of Eetanercept with each autoinjector and indicated a preference for an autoinjector in the Subject Preference Questionnaire. N = number of participants with RA and PsO respectively.||percentage of participants||95% Confidence Interval|Number
659736|NCT01875978|Primary|Endothelial Protective Effect of Phytosterols on Patients With Non-alcoholic Fatty Liver Disease|"Ceck serum endothelial progenitor cells in the monocytes group but not in the lymphocytes group. Serum EPCs in the monocytes group provide the effect of endothelial repair to support novel vessel protection.
Cytometry flow check 150,000 cells per time including monocytes and lymphocytes group. Positive cells is the EPCs in the monocytes group. Stain with KDR, call kinase insert domain receptor, also call as VEGF receptor-2.
Mid-point: end of first intervention (Group A: after phytosterols, Group B: after placebo) End-point: end of second intervention (Group A: after placebo, Group B: after phytosterols)"|after 4 weeks phytosterols 1.8g/day|||positive cells/150,000 cells||Standard Error|Mean
659737|NCT01875978|Primary|Insulin-like Growth Factor-1 Effect of Phytosterols on Patients With Nonalcoholic Fatty Liver Disease|"Check serum Insulin-like growth factor-1 levels. Serum Insulin-like growth factor-1 (IGF-1) influence metabolic status and reduce EPCs apoptosis via IGF-1 receptor.
Mid-point: end of first intervention (Group A: after phytosterols, Group B: after placebo) End-point: end of second intervention (Group A: after placebo, Group B: after phytosterols)"|after 4 weeks phytosterols 1.8g/day|||ng/ml||Standard Error|Mean
659738|NCT01875978|Primary|Anti-oxidative Capacity of Phytosterols on Patients With Fatty Liver Disease|"Check serum anti-oxidative capacity, especially the serum superoxide dismutase (SOD) levels.Serum SOD provide the anti-oxidative capacity in lipid oxidation.
Mid-point: end of first intervention (Group A: after phytosterols, Group B: after placebo) End-point: end of second intervention (Group A: after placebo, Group B: after phytosterols)"|after 4 weeks phytosterols 1.8g/day|||U/mg-protein||Standard Error|Mean
659739|NCT01875978|Primary|Metabolic Effect of Phytosterols on Patients With Nonalcoholic Fatty Liver Disease|"Check serum metabolic status: levels in total cholesterol, low density lipoprotein-cholesterol, fasting glucose
Check serum anti-inflammatory status: levels in C reactive protein
Mid-point: end of first intervention (Group A: after phytosterols, Group B: after placebo) End-point: end of second intervention (Group A: after placebo, Group B: after phytosterols)"|after 4 weeks phytosterols 1.8g/day|||mg/dl||Standard Error|Mean
659740|NCT01875848|Secondary|Patient Global Impression of Change (PGIC)|"The Patient Global Impression of Change Scale (PGIC) is one question capturing the individual's overall perception of efficacy of treatment in a clinical trial. It uses verbal outcome categories on a 7-point scale with very much worse and very much better as anchors and no change in the middle. The verbal categories were coded on a scale with -3 very much worse,+3 very much better, and 0 same. To calculate the mean and standard deviation of each group (Bup/Opioid Increase) we took the sum of each participants final PGIC score and divided by the total number of participants."|12 wks|This group of subjects consisted of five males. One Buprenorphine subject aged-72 and four Opioid Dose Escalation subjects aged- 66,77,78,and 58.||units on a scale||Standard Deviation|Mean
659741|NCT01875848|Primary|Change in Numeric Rating Scale of Pain Severity|Validated 11 pt scale 0-10, to evaluate a patient's current severity of pain. A rating of 0 indicates no pain while 10 indicates the worst pain imaginable. A score of 4 or above is considered a clinically significant pain level according to VHA treatment guidelines.|Baseline and 12 wks|This group of subjects consisted of five males. One Buprenorphine subject aged-72 and four Opioid Dose Escalation subjects aged- 66,77,78,and 58.||units on a scale||Standard Deviation|Mean
659744|NCT01875783|Secondary|Retinal Referral Rates for Patients With DME|Percentage of participants who are referred to a retina specialist for evaluation and management of DME after OCT imaging and OCT-guided referral algorithm as compared with independently recorded “standard care” referrals to retina specialists by diabetologists masked to OCT results|Baseline visit||||||
659745|NCT01875783|Primary|Rates of Retina Care Referral for Patients With Diabetic Macular Edema|Percentage of participants who are referred to a retina specialist for evaluation and management of DME after OCT imaging and OCT-guided referral algorithm|Baseline visit|||Participants|||Count of Participants
659746|NCT01875731|Secondary|Treatment Failure in Each Group|Number of participants with persistence of fever after 2 days, or tachypnea or diminishing in respiratory rate less than 5 bpm. after 2 days, or signs of severe pneumonia or requiring or changing antibiotics at any time.|1, 2, 5, 7 and 10 days from baseline|||participants|||Number
659747|NCT01875731|Primary|Use of Antibiotics in Each Group|Number of participants with use of any antibiotic, at any time after diagnosis|At day 7 from baseline|||participants|||Number
659748|NCT01875510|Primary|Number of Participants With Retinopathy of Prematurity|The number of Participants with Retinopathy of Prematurity will be defined.|Corrected age 32 weeks or postnatal 28th day|||participants|||Number
659749|NCT01875471|Primary|Subjective Ease of Lens Removal|After 1-week of lens wear, each subject was asked to rate a question, 'Ease of taking the lenses off of your eyes', using 5-point scale (1=Excellent, 2=Very Good, 3=Good, 4=Fair, 5=Poor).|Day 7|||participants|||Number
659750|NCT01875445|Secondary|The Massachusetts General Hospital (MGH) Hairpulling Scale|The entire study for an individual subject will last 10 weeks. Every 2 weeks the subject will take the MGH Hairpulling Scale for the duration of the 10 weeks, baseline and final visits will be use for general final outcome assessment. The scale itself asses severity of hair pulling.|Once every two weeks for the 10 weeks of the study|Last observation carried forwards for general averages.||units on a scale||Standard Deviation|Mean
659751|NCT01875445|Primary|The National Institute of Mental Health Trichotillomania Symptom Severity Scale (NIMH-TSS)|The entire study for an individual subject will last 10 weeks. Every 2 weeks the subject will take the NIMH-TSS for the duration of the 10 weeks, but only baseline and final values will be used for general final outcome assessment. The scale itself asses severity of hair pulling.|Once every two weeks for the 10 weeks of the study|Last observation carried forward for general means.||units on a scale||Standard Deviation|Mean
659752|NCT01875159|Primary|Number of Seconds of Intermittent Hypoxia Per Hour|Number of seconds of Intermittent hypoxia per hour of pulse oximeter recording less than 90% oxygen saturation|35, 36, 37, 38 weeks postmenstrual age|Intention to treat||seconds per hour||Standard Deviation|Mean
659753|NCT01875159|Primary|Episodes of Intermittent Hypoxia Per Hour|Number of episodes of Intermittent hypoxia per hour of pulse oximeter recording less than 90% oxygen saturation|35, 36, 37, 38 weeks postmenstrual age|Intention to treat||Events per hour||Standard Deviation|Mean
659754|NCT01874951|Secondary|Remission Rate|Remission is defined as a final HAM-D-17 score of 7 or less. Remission rate is the percent of patients who attain this threshold score.|Remission rate at 3 weeks.|Study completers.||Participants|||Count of Participants
659755|NCT01874951|Secondary|Response Rate|Response is defined as an improvement in HAM-D-17 score of greater than or equal to 50% compared to baseline score. Response rate is the percent of patients who attain this threshold degree of improvement.|Response rate after 3 weeks|Study completers.||Participants|||Count of Participants
659756|NCT01874951|Secondary|Final CGI-I Score|Clinical Global Improvement-Improvement Scale. The CGI-I scale is a one item scale that measures overall change in patient’s global condition compared to when they were entered into the study. The scale is graded from 1-7, where 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. Thus higher scores indicate greater worsening, and lower scores indicate greater improvement. The lowest possible score (indicating maximum improvement) is 1, and the highest possible score (indicating greatest worsening) is 7.|From baseline to week 3|Study completers.||units on a scale||Standard Deviation|Mean
659757|NCT01874951|Secondary|Change in CGI-S Total Score|Clinical Global Improvement-Severity Scale. The CGI-S score is a one-item scale that measures severity of depression, scored from 1-7, where 1 = no depression is present, 2 = borderline depression, 3 = mild depression, 4 = moderate depression, 5 = marked depression, 6 = severe depression, and 7 = among the most extremely depressed patient. Thus higher scores indicate greater depressive severity. The change in CGI-S score can represent a drop from 7 (maximum severity) to 1 (no depression) or -6. There is no minimum CGI-S score required for admission, but a minimum score of 18 on the HAMD17 corresponds to approximately a score of 4 on the CGI-S. Thus a maximum worsening would be from 4 to 7, or +3.|Change from baseline to week 3|Study completers.||units on a scale||Standard Deviation|Mean
659758|NCT01874951|Secondary|Change in MADRS-15 Total Score|Montgomery-Asberg Depression Rating Scale- 15 item. The change in scores depends on the difference between the initial (baseline) score and the final score at the conclusion of the double blind treatment period. There is no formal range of score changes, since they depend on the initial and final score. A negative score represents a lowering in the score from baseline to end (improvement), and a positive score indicates an increase in score from baseline to end (worsening). A zero score would indicate no change. In theory, the maximum drop in score would be from 90 to zero, or -90. There is no minimum score on the MADRS-15 required for study entry, since the HAMD-17 was the sole entry criteria. However, a score of 18 on the HAMD17 corresponds to approximately a score of 21 on the MADRS-10. A maximum estimated increase would thus be from 21 to 90, or +69.|Change from baseline to week 3|Study completers.||units on a scale||Standard Deviation|Mean
659759|NCT01874951|Secondary|Change in MADRS-10 Total Score|Montgomery-Asberg Depression Rating Scale- 10 item. The change in scores depends on the difference between the initial (baseline) score and the final score at the conclusion of the double blind treatment period. There is no formal range of score changes, since they depend on the initial and final score. A negative score represents a lowering in the score from baseline to end (improvement), and a positive score indicates an increase in score from baseline to end (worsening). A zero score would indicate no change. In theory, the maximum drop in score would be from 60 to zero, or -60. There is no minimum score on the MADRS-10 required for study entry, since the HAMD-17 was the sole entry criteria. However, a score of 18 on the HAMD17 corresponds to approximately a score of 21 on the MADRS-10. A maximum estimated increase would thus be from 21 to 60, or +39.|Change from baseline to week 3|Study completers.||units on a scale||Standard Deviation|Mean
659760|NCT01874951|Secondary|Change in HAM-D28 Total Score|Hamilton Depression Scale-28 item. The change in scores depends on the difference between the initial (baseline) score and the final score at the conclusion of the double blind treatment period. There is no formal range of score changes, since they depend on the initial and final score. A negative score represents a lowering in the score from baseline to end (improvement), and a positive score indicates an increase in score from baseline to end (worsening). A zero score would indicate no change. In theory, the maximum drop in score would be from 81 to zero, or -81. A maximum increase would be from 18 (the minimum score required for admission) to 81, or +63.|Change from baseline to week 3|Study subjects who completed the protocol||units on a scale||Standard Deviation|Mean
659761|NCT01874951|Primary|Change in HAM-D-17 Total Score|Hamilton Depression Scale-17 (HAM-D-17) item. The change in scores depends on the difference between the initial (baseline) score and the final score at the conclusion of the double blind treatment period. There is no formal range of score changes, since they depend on the initial and final score. A negative score represents a lowering in the score from baseline to end (improvement), and a positive score indicates an increase in score from baseline to end (worsening). A zero score would indicate no change. In theory, the maximum drop in score would be from 52 to zero, or -52. A maximum increase would be from 18 (the minimum score required for admission) to 52, or +34.|Change from baseline to week 3|Study completers.||units on a scale||Standard Deviation|Mean
659762|NCT01874665|Secondary|Pharmacokinetic (PK) Parameters of Steady-state Plasma Concentration|PK samples will be taken to assess limited elements of PK in the total patient population|Up to 1 month after the start of treatment||05/2017||||
659763|NCT01874665|Secondary|Safety|Measured by routine physical and laboratory evaluations, ECG, ECHO, and Adverse Event (AE) monitoring. To evaluate the safety and tolerability of ponatinib in the total patient population|From date of enrollment until the End-of-Treatment, assessed up to 3 years||05/2017||||
659764|NCT01874665|Secondary|Overall Survival (OS)|Defined as the interval between the first dose of study drug and death due to any cause, censored at the last contact date. To assess OS in each cohort and in the total patient population|From first dose of drug until the end of the study or death, whichever came first, assessed up to 3 years||05/2017||||
659765|NCT01874665|Secondary|Objective Response Rate (ORR)|Defined as the composite of CR and PR, assessed for each cohort and in the total patient population|From date of enrollment until discontinuation or the end of the study, whichever came first, assessed up to 3 years||05/2017||||
659766|NCT01874665|Secondary|Progression-free Survival (PFS)|Defined as the duration of time from start of study drug administration to time of objective disease progression or death due to any cause, whichever may come first. To assess PFS in each cohort and in the total patient population|From date of enrollment until the end of the study or disease progression or death due to any cause, whichever came first, assessed up to 3 years||05/2017||||
659767|NCT01874665|Secondary|Clinical Benefit Rate (CBR) in Cohort B|To assess clinical benefit rate in patients with GIST that lacks KIT exon 11 mutations (Cohort B) and in the total patient population|16 weeks after first dose|||percentage (%) of participants||95% Confidence Interval|Number
659768|NCT01874665|Primary|Clinical Benefit Rate (CBR) in Cohort A|To assess clinical benefit rate in patients with KIT exon 11-mutant GIST. Defined as the composite of complete response (CR), partial response (PR), and stable disease (SD) lasting ≥16 weeks per modified RECIST 1.1 as a measure of disease control|16 weeks after first dose|||percentage (%) of participants||95% Confidence Interval|Number
659769|NCT01874340|Secondary|Number of Particpants With Adverse Events as a Measure of Safety and Tolerability|Number of particpants with Adverse events as a measure of safety and tolerability|6 months|The safety set consists of all subjects who received at least one dose of study medication. Subjects will be analyzed according to the treatment received.||Participants|||Number
659770|NCT01874340|Secondary|Change in Total Volume of T2-weighted Lesions|Due to early termination this trial was not powered for efficacy no statistical analysis was performed|Baseline, Month 6|Due to the early termination of the study and just one patient completing treatment as planned, no statistical analyses could be performed for the efficacy endpoints defined in the protocol.|||||
659771|NCT01874340|Secondary|Combined Unique Active Lesions (CUAL)|Due to early termination this trial was not powered for efficacy no statistical analysis was performed|Months 3, 4, 5, 6|Due to the early termination of the study and just one patient completing treatment as planned, no statistical analyses could be performed for the efficacy endpoints defined in the protocol.|||||
659772|NCT01874340|Secondary|Annualized Relapse Rate|Due to early termination this trial was not powered for efficacy no statistical analysis was performed|6 Months|Due to the early termination of the study and just one patient completing treatment as planned, no statistical analyses could be performed for the efficacy endpoints defined in the protocol.|||||
659773|NCT01874340|Primary|Cumulative Number of New Gadolinium [Gd]-Enhancing T1-weighted Lesions|Due to early termination this trial was not powered for efficacy no statistical analysis was performed|Months 3, 4, 5, 6|Due to the early termination of the study and just one patient completing treatment as planned, no statistical analyses could be performed for the efficacy endpoints defined in the protocol.|||||
659774|NCT01874275|Other Pre-specified|Sleep Arousal Statistics Index at 365 Days|Sleep / Arousal Statistics Index (ASI) description: Sleep Studies were obtained twice before beginning the study. The second sleep study data was used as baseline. A follow up sleep study was obtained after 6 months (180 days) of Active or Placebo VECTTOR treatment. Sleep, breathing, arousal(s), and limb movements were scored manually according to guidelines of the American Academy of Sleep Medicine. The efficacy of the outcome measure of ASI is demonstrated by a decrease in the value between Baseline and 180 days. The ASI is measured by the number of times sleep is interrupted per hour. Lower ASI values/numbers indicate improved sleep quality.|Baseline to 365 days||03/2015||||
659775|NCT01874275|Secondary|Percent Change in Muscle Strength|Muscle strength testing (Wireless Tracker system) - All muscle strength testing was performed using the JTech computerized testing system, including Goniometry, Grip Testing, Inclinometry, Muscle Testing and Joint Range of Motion. Testing occurred at Baseline (Day 0), 30, 60, 90, 180 and 365 days to determine changes in muscle strength. JTech computerized testing system determined the muscle strength by radio signals from a strain gauge measuring strength of the participant’s muscles. 44 separate tests were performed for muscle strength for each participant at each time interval. Efficacy is defined as an increase in the strength measurement (pounds) from Baseline to 365 days.|Baseline to 365 days|||percentage of change||Standard Deviation|Mean
659776|NCT01874275|Secondary|Percent Change in Percent Range of Motion From Baseline to 365 Days|Range of Motion (ROM) testing (Wireless Tracker System) - All muscle and joint testing was performed using the JTech computerized testing system, including Goniometry, Grip Testing, Inclinometry, Muscle Testing and Joint Range of Motion. Testing occurred at Baseline (Day 0), 30, 60, 90, 180 and 365 days to determine changes in joint Range of Motion. JTech computerized testing system determined the joint range of motion by radio signals from a goniometer measuring movement of the participants' joints. 44 separate tests were performed for Range of Motion for each participant at each time interval. The results from the range of motion tests were averaged the percent change from baseline to 365 days. Efficacy is defined as an increase in range of motion.|Baseline to 365 days|||percentage of change||Standard Deviation|Mean
659777|NCT01874275|Other Pre-specified|Percent Change in Sleep Quality Arousal Statistics Index (ASI) From Baseline to 180 Days|Sleep / Arousal Statistics Index (ASI) description: Sleep Studies were obtained twice before beginning the study. The second sleep study data was used as baseline. A follow up sleep study was obtained after 6 months (180 days) of Active or Placebo VECTTOR treatment. Sleep, breathing, arousal(s), and limb movements were scored manually according to guidelines of the American Academy of Sleep Medicine. The efficacy of the outcome measure of ASI is demonstrated by a percent improvement between Baseline and 180 days. The ASI is measured by the number of times sleep is interrupted per hour.|Baseline to 180 days|||percentage of change||Standard Deviation|Mean
659778|NCT01874275|Secondary|Percent Change in Muscle Strength|Muscle strength testing (Wireless Tracker system) - All muscle strength testing was performed using the JTech computerized testing system, including Goniometry, Grip Testing, Inclinometry, Muscle Testing and Joint Range of Motion. Testing occurred at Baseline (Day 0), 30, 60, 90, and 180 days to determine changes in muscle strength. JTech computerized testing system determined the muscle strength by radio signals from a strain gauge measuring strength of the participant’s muscles. 44 separate tests were performed for muscle strength for each participant at each time interval. Efficacy is defined as an increase in the strength measurement (pounds) from Baseline to 180 days.|Baseline to 180 days|||percentage of change||Standard Deviation|Mean
659779|NCT01874275|Primary|Percent Change in Range of Motion From Baseline to 180 Days|Range of Motion (ROM) testing (Wireless Tracker System) - All muscle and joint testing was performed using the JTech computerized testing system, including Goniometry, Grip Testing, Inclinometry, Muscle Testing and Joint Range of Motion. Testing occurred at Baseline (Day 0), 30, 60, 90 and 180 days to determine changes in joint Range of Motion. JTech computerized testing system determined the joint range of motion by radio signals from a goniometer measuring movement of the participants' joints. 44 separate tests were performed for Range of Motion for each participant at each time interval. The results from the range of motion tests were averaged the percent change from baseline to 180 days. Efficacy is defined as an increase in range of motion.|Baseline to 180 days|||percentage of change||Standard Deviation|Mean
659780|NCT01874262|Primary|Non-adherence Score|The primary composite endpoint was defined as a non-adherence score based on the combination of adherence failure events and treatment gaps. Adherence failure events were defined as 2 missed doses during an observation cycle of up to 7 days. The first registered missed dose of ticagrelor in the e-diary initiated an observation cycle of 1 week. If a second missed dose was registered during the week, this was considered an adherence failure event. The third missed dose initiated a new observation cycle, and the process restarted. If the second missed dose was registered after more than 1 week, this was not defined as an adherence failure event, but initiated a new observation cycle. Treatment gaps were defined as patient reported gaps of 4 consecutive doses.|6 months|||Non-adherence score||Standard Deviation|Mean
659781|NCT01874145|Secondary|Change From Start of Extension Period to Month 8 (and to Endpoint Visit) in in the Participant-Reported Treatment Satisfaction Questionnaire for Medication (TSQM-9) Satisfaction Score|"The Treatment Satisfaction Questionnaire for Medication (TSQM-9) is a psychometric measure of a patient's satisfaction with medication. It consists of 3 subscales: effectiveness, convenience and global satisfaction. The scores were computed by adding items for each domain, i.e. 1 to 3 for effectiveness, 4 - 6 for convenience and 7 to 9 for global satisfaction. This outcome focuses on global satisfaction, items 7-9. TSQM-9 participant perception of satisfaction score was calculated as: ([sum(Item 7 to Item 9) - 3] divided by 14) * 100. The full range was -100 to 100, with positive change from baseline indicating improvement satisfaction with medication.
The Extension Period endpoint visit was defined as the last observed post-baseline data of the Extension Period."|Month 4 (baseline for extension period), Month 8, endpoint visit|Full analysis set Extension Period||units on a scale||Standard Deviation|Mean
659782|NCT01874145|Primary|Injection-Related Adverse Events in the Extension Period|Injection-related (IR) adverse events refers to all local injection site reactions and/or symptoms or events related to immediate post injection reaction (flushing, chest pain, palpitations, anxiety, dyspnea, throat constriction, and/or urticaria).|Month 5 up to Month 10|ITT extension analysis set of participants who had at least one injection-related AE||events|||Number
659783|NCT01874145|Secondary|Change From Start of Extension Period to Month 8 (and to Endpoint Visit) in in the Participant-Reported Treatment Satisfaction Questionnaire for Medication (TSQM-9) Convenience Score|"The Treatment Satisfaction Questionnaire for Medication (TSQM-9) is a psychometric measure of a patient's satisfaction with medication. It consists of 3 subscales: effectiveness, convenience and global satisfaction. The scores were computed by adding items for each domain, i.e. 1 to 3 for effectiveness, 4 - 6 for convenience and 7 to 9 for global satisfaction. This outcome focuses on convenience items 4-6, with each question graded on a scale of 1 (extreme dissatisfaction) to 7 (extreme satisfaction). TSQM-9 participant perception of convenience score was calculated as: ([sum (Item 4 to Item 6) – 3] divided by 18) * 100. The full range was -100 to 100, with positive change from baseline indicating improvement.
The Extension Period endpoint visit was defined as the last observed post-baseline data of the Extension Period."|Month 4 (baseline for extension period), Month 8, endpoint visit|Full analysis set Extension Period||units on a scale||Standard Deviation|Mean
659803|NCT01874054|Primary|Incidence of Adverse Events|All AEs reported after initiation of treatment and pre-existing conditions that worsen after initiation of treatment will be considered treatment-emergent AEs (TEAEs). All AEs will be coded by system organ class, MedDRA preferred term, and severity grade using NCI CTCAE V4.03. All recorded AEs will be included in the data listings.|Up to 16 cycles plus 30 days; approximately 12 months|All subjects who were enrolled and received at least 1 dose of brentuximab vedotin.||Participants|||Count of Participants
659784|NCT01874145|Secondary|Change From Start of Extension Period (Month 4) to Month 8 (and to Endpoint Visit) in the Participant-Reported Impact on Psychological Wellbeing Using Multiple Sclerosis Impact Scale (MSIS-29 PRO)|"The psychological wellbeing assessment portion of the MSIS-29 is comprised of 9 questions in which participants rate the impact of MS on their day-to-day life during the past two weeks from 1=no impact to 5=extreme impact for a total score of 9-45. Negative change from baseline scores indicate improvement in psychological wellbeing.
The Extension Period endpoint visit was defined as the last observed post-baseline data of the Extension Period."|Month 4 (baseline for extension period), Month 8, endpoint visit|Full analysis set Extension Period||units on a scale||Standard Deviation|Mean
659785|NCT01874145|Secondary|Change From Start of Extension Period (Month 4) to Month 8 (and to Endpoint Visit) in the Participant-Reported Impact on Physical Wellbeing Using Multiple Sclerosis Impact Scale (MSIS-29 PRO)|"The physical wellbeing assessment portion of the MSIS-29 is comprised of 20 questions in which participants rate the impact of MS on their day-to-day life during the past two weeks from 1=no impact to 5=extreme impact for a total score of 20-100. Negative change from baseline scores indicate improvement in physical wellbeing.
The Extension Period endpoint visit was defined as the last observed post-baseline data of the Extension Period."|Month 4 (baseline for extension period), Month 8, endpoint visit|Full analysis set Extension Period||units on a scale||Standard Deviation|Mean
659786|NCT01874145|Secondary|Injection Site Reaction Events in the Extension Period|"This outcome includes injection-related adverse events referring to all local injection site reactions (ISR).
For cases in which more than 1 ISR adverse event started on the same date for the same patient, these were counted as 1 ISR adverse event for that patient."|Month 5 up to Month 10|ITT extension analysis set of participants who had injection site reaction AEs.||events|||Number
659787|NCT01874145|Secondary|Injection Site Reaction Event Rate Per Year in the Extension Period|"This outcome includes injection-related adverse events referring to all local injection site reactions (ISR). Rate was calculated as # ISR events/the total exposure to study drug in years.
For cases in which more than 1 ISR adverse event started on the same date for the same patient, these were counted as 1 ISR adverse event for that patient."|Month 5 up to Month 10|ITT extension analysis set of participants who had injection site reaction AEs.||events per year|||Number
659788|NCT01874145|Secondary|Change From Baseline to Month 4 in in the Adjusted Mean Participant-Reported Treatment Satisfaction Questionnaire for Medication (TSQM-9) Satisfaction Score in the Core Period|"The Treatment Satisfaction Questionnaire for Medication (TSQM-9) is a psychometric measure of a patient's satisfaction with medication. It consists of 3 subscales: effectiveness, convenience and global satisfaction. The scores were computed by adding items for each domain, i.e. 1 to 3 for effectiveness, 4 - 6 for convenience and 7 to 9 for global satisfaction. This outcome focuses on global satisfaction, items 7-9. TSQM-9 participant perception of satisfaction score was calculated as: ([sum(Item 7 to Item 9) – 3] divided by 14) * 100. The full range was -100 to 100, with positive change from baseline indicating improvement satisfaction with medication.
The estimated change from baseline to month 4 adjusted for months 1 and 2 was generated using a mixed model repeated measures analysis adjusted for baseline TSQM convenience score, treatment group, month, treatment by month interaction."|Month 0 (baseline), Months 1, 2 4 (or early termination visit)|Full analysis set. Some scales/forms were not completed (including partially completed) and therefore not included in this analysis.||units on a scale||Standard Error|Mean
659789|NCT01874145|Secondary|Change From Baseline to Month 4 in in the Adjusted Mean Participant-Reported Treatment Satisfaction Questionnaire for Medication (TSQM-9) Convenience Score in the Core Period|"The Treatment Satisfaction Questionnaire for Medication (TSQM-9) is a psychometric measure of a patient's satisfaction with medication. It consists of 3 subscales: effectiveness, convenience and global satisfaction. The scores were computed by adding items for each domain, i.e. 1 to 3 for effectiveness, 4 - 6 for convenience and 7 to 9 for global satisfaction. This outcome focuses on convenience items 4-6, with each question graded on a scale of 1 (extreme dissatisfaction) to 7 (extreme satisfaction). TSQM-9 participant perception of convenience score was calculated as: ([sum (Item 4 to Item 6) – 3] divided by 18) * 100. The full range was -100 to 100, with positive change from baseline indicating improvement.
The estimated change from baseline to month 4 adjusted for months 1 and 2 was generated using a mixed model repeated measures analysis adjusted for baseline TSQM convenience score, treatment group, month, treatment by month interaction."|Month 0 (baseline), Months 1, 2 4 (or early termination visit)|Full analysis set. Some scales/forms were not completed (including partially completed) and therefore not included in this analysis.||units on a scale||Standard Error|Mean
659790|NCT01874145|Secondary|Change From Baseline to Month 4 in in the Adjusted Mean Participant-Reported Impact on Psychological Wellbeing Using Multiple Sclerosis Impact Scale (MSIS-29 PRO) in the Core Period|"The psychological wellbeing assessment portion of the MSIS-29 is comprised of 9 questions in which participants rate the impact of MS on their day-to-day life during the past two weeks from 1=no impact to 5=extreme impact for a total score of 9-45. Negative change from baseline scores indicate improvement in psychological wellbeing over time.
The estimated change from baseline to month 4 adjusted for months 1 and 2 was generated using a mixed model repeated measures analysis adjusted for baseline MSIS-29 psychological score, treatment group, month, treatment by month interaction."|Month 0 (baseline), Months 1, 2 4 (or early termination visit)|Full analysis set. Some scales/forms were not completed (including partially completed) and therefore not included in this analysis.||units on a scale||Standard Error|Mean
659791|NCT01874145|Primary|Injection-Related Adverse Event Rate Per Year in the Extension Period|"Injection-related (IR) adverse events refers to all local injection site reactions and/or symptoms or events related to immediate post injection reaction (flushing, chest pain, palpitations, anxiety, dyspnea, throat constriction, and/or urticaria). Rate was calculated as # IR events/the total exposure to study drug in years.
For cases in which more than 1 IR adverse event started on the same date for the same patient, these were counted as 1 IR adverse event for that patient."|Month 5 up to Month 10|ITT extension analysis set of participants who had at least one injection-related AE||events per year|||Number
659820|NCT01873417|Secondary|Percentage of DMF-treated Participants Who Required GI Symptomatic Therapy|Percentage of participants reporting that they required GI symptomatic therapy, based on the MOGISS.|12 Weeks|Safety Population (participants who received at least 1 dose of DMF, recorded in diary data)||percentage of participants|||Number
659792|NCT01874145|Secondary|Change From Baseline to Month 4 in in the Adjusted Mean Participant-Reported Impact on Physical Wellbeing Using Multiple Sclerosis Impact Scale (MSIS-29 PRO) in the Core Period|"The physical wellbeing assessment portion of the MSIS-29 is comprised of 20 questions in which participants rate the impact of MS on their day-to-day life during the past two weeks from 1=no impact to 5=extreme impact for a total score of 20-100. Negative change from baseline scores indicate improvement in physical wellbeing over time.
The estimated change from baseline to month 4 adjusted for months 1 and 2 was generated using a mixed model repeated measures analysis adjusted for baseline MSIS-29 physical score, treatment group, month, treatment by month interaction."|Month 0 (baseline), Months 1, 2, 4 (or early termination visit)|Full analysis set. Some scales/forms were not completed (including partially completed) and therefore not included in this analysis.||units on a scale||Standard Error|Mean
659793|NCT01874145|Secondary|Adjusted Mean Estimates for Injection Site Reaction Event Rate Per Year in the Core Period|"This outcome includes injection-related adverse events referring to all local injection site reactions (ISR). Rate was calculated as # ISR events/the total exposure to study drug in years.
For cases in which more than 1 ISR adverse event started on the same date for the same patient, these were counted as 1 ISR adverse event for that patient.
Parameter statistics were generated from a Poisson regression model with natural log of treatment duration (years) as an offset variable, and adjusted for baseline EDSS score, treatment group, age, sex, number of relapses in the 2 years prior to screening, in which a contrast comparing treatment groups were constructed. Adjusted mean estimates were adjusted estimates of event rates within treatment group."|Day 1 to Month 4|Safety analysis set||events per year||Standard Error|Mean
659794|NCT01874145|Other Pre-specified|Percentage of Participants With Adverse Events Other Than Injection Related Reactions During the Core Period and the Extension Period|An adverse event was defined in the protocol as any untoward medical occurrence in a patient that developed or worsened in severity during the conduct of the clinical study of a pharmaceutical product and did not necessarily have a causal relationship to the study drug. This outcome summarizes the % of participants who had AEs other than injection related reactions. Injection-related (IR) adverse events referring to all local injection site reactions and/or symptoms or events related to immediate post injection reaction (flushing, chest pain, palpitations, anxiety, dyspnea, throat constriction, and/or urticaria).|Day 1 to Month 4 (core period); Month 5 to 10 (extension period)|Safety analysis set||percentage of participants|||Number
659795|NCT01874145|Primary|Adjusted Mean Estimates for Injection-Related Adverse Event Rate Per Year in the Core Period|"Injection-related (IR) adverse events refers to all local injection site reactions and/or symptoms or events related to immediate post injection reaction (flushing, chest pain, palpitations, anxiety, dyspnea, throat constriction, and/or urticaria). Rate was calculated as # IR events/the total exposure to study drug in years.
For cases in which more than 1 IR adverse event started on the same date for the same patient, these were counted as 1 IR adverse event for that patient.
Parameter statistics were generated from a Poisson regression model with natural log of treatment duration (years) as an offset variable, and adjusted for baseline EDSS score, treatment group, age, sex, number of relapses in the 2 years prior to screening, in which a contrast comparing treatment groups were constructed. Adjusted mean estimates were adjusted estimates of event rates within treatment group."|Day 1 to Month 4|Safety analysis set||events per year||Standard Error|Mean
659796|NCT01874132|Other Pre-specified|Quality of Life|Measured by the Satisfaction With Life Scale.|One year||||||
659797|NCT01874132|Secondary|Risk of Falls|Descriptive frequency of the number of participants who took ≥12 seconds to complete the Timed Get-up and Go test, and those who took less than 12 seconds (low risk of falling).|One year|||Participants|||Count of Participants
659798|NCT01874132|Primary|Cardiovascular Disease Risk Factors|Descriptive frequency of the number of cardiovascular risk factors aggregated in each participant. The risk factors considered were: (i) hypertension; (ii) obesity; and (iii) dyslipidemia.|one year|Only 48 participants completed the body composition, blood pressure and hematology assessments, and were included in analysis.||participants|||Number
659799|NCT01874054|Secondary|Progression-free Survival|The time from first dose of study medication to first documentation of disease progression/relapse, or to death due to any cause, whichever occurs first.|Up to 3 years|All patients who received at least 2 cycles of combination treatment and had a baseline tumor assessment and at least 1 post-baseline tumor assessment, or who had documented disease progression (including clinical disease progression) at any time after the first dose of combination therapy.||months||95% Confidence Interval|Median
659800|NCT01874054|Secondary|Duration of Response|The time from first observation of remission to disease progression/relapse or death from any cause, whichever occurs first.|Up to 3 years|Patients with a complete or partial response who received at least 2 cycles of combination treatment and had a baseline tumor assessment and at least 2 post-baseline tumor assessment, or who had documented disease progression (including clinical disease progression) at any time after the first dose of combination therapy.||months||95% Confidence Interval|Mean
659801|NCT01874054|Secondary|Overall Best Response Rate|Percentage of participants who achieved a best response of complete remission (CR, disappearance of all evidence of disease), partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites), stable disease (SD, failure to obtain a complete or partial response or progressive disease), or progressive disease (PD, any new lesion or increase by 50% or more of previously involved sites from nadir) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma|Every 3 months for up to 3 years|All patients who received at least 2 cycles of combination treatment, had a baseline tumor assessment, and at least 1 post-baseline tumor assessment, or who had documented disease progression (including clinical disease progression) any time after the first dose of combination therapy.||Participants|||Count of Participants
659802|NCT01874054|Secondary|Incidence of Dose-limiting Toxicities|Incidence of dose-limiting toxicity (DLT) was evaluated in an initial safety cohort of 10 patients who were followed for protocol-defined DLT events until Cycle 2 Day 1.|Up to 3 weeks; the first cycle of therapy through the first day of Cycle 2.|All patients who enrolled and received at least 1 dose of brentuximab vedotin.||Participants|||Count of Participants
659884|NCT01871532|Secondary|Percentage of Cycles With Multifollicular Development|The multifollicular development was defined as the number of cycles with multifollicular development of three or more follicles greater than or equal to 14 millimeter|Baseline up to 4 weeks|Data was not assessed since the study was terminated early due to the delay in providing additional study drug following a batch recall.|||||
659804|NCT01874054|Primary|Complete Remission Rate|Complete remission rate among all subjects (Phase 1 and 2 combined) treated at the dose level selected for Phase 2. Complete remission (CR) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma is a disappearance of all evidence of disease.|Up to 16 cycles plus 30 days; approximately 12 months|All patients who received at least 2 cycles of combination treatment at the recommended dose level and had a baseline tumor assessment and at least 1 postbaseline tumor assessment, or who had documented disease progression (including clinical disease progression) at any time after the first dose of combination therapy at the recommended dose level.||percentage of participants||95% Confidence Interval|Number
659805|NCT01873989|Primary|Change in Sexual Dysfunction From Baseline to Week 8|Decreased sexual dysfunction will be assessed using the Erectile Function (EF) subscale of the International Index of Erectile Function (IIEF). The EF subscale has 6 items scored on a zero to five Likert-type scale. Change in sexual dysfunction was calculated by subtracting the mean EF subscale score at week 8 from the mean EF subscale score at baseline. The range of the EF subscale is 0-30 (with higher scores representing greater functioning). The Cut-offs for the EF subscales are as follows: no erectile dysfunction (score 26–30), mild erectile dysfunction (22–25), mild to moderate erectile dysfunction(17–21), moderate erectile dysfunction (11–16), and severe erectile dysfunction (0–10).|8 weeks|||units on a scale||Standard Deviation|Mean
659806|NCT01873989|Primary|Change in Pain Ratings|Pain ratings will be assessed by self-report (4 items from Brief Pain Inventory). Change in pain ratings was assessed by examining the differences between pain ratings at baseline and week 8. Higher values are considered to be a worse outcome. The scale range is 0-10.|8 weeks|||units on a scale||95% Confidence Interval|Mean
659807|NCT01873989|Primary|Number of Participants Demonstrating Abstinence|Number of participants who provided four consecutive weekly urines that were negative for illicit opioids in weeks 5 through 8.|8 weeks|||Participants|||Count of Participants
659808|NCT01873950|Primary|Placebo, and Baseline-adjusted Changes in Ventricular Gradient|Compute maximum mean placebo, and baseline-adjusted change for: ventricular gradient (mV*ms).|24 hours|||mV*ms||95% Confidence Interval|Least Squares Mean
659809|NCT01873950|Primary|Placebo, and Baseline-adjusted Changes in Spatial QRS-T Angle|Compute maximum mean placebo, and baseline-adjusted change for: spatial QRS-T angle (degrees)|24 hours|||degrees||95% Confidence Interval|Least Squares Mean
659810|NCT01873950|Secondary|Change in PR, QRS, J-Tpeak, Tpeak-Tend, QTc, Spatial QRS-T Angle and Ventricular Gradient Using Exposure/Response|"The exposure response analysis will be performed for each treatment and will use a linear or nonlinear model (as determined by visual inspection) to quantify the relationship between exposure and Baseline and placebo adjusted change from Baseline for each ECG parameter (same as for primary analysis).
The magnitude of change (mean and 90% CI) in QTc for the observed mean Cmax for each drug, highest individual concentration observed with the dose, and other appropriate concentrations pertaining to drug may be calculated."|24 hours||06/2016||||
659811|NCT01873950|Secondary|Change in Relationship Between Heart Rate and PR, QRS, J-Tpeak, Tpeak-Tend, QTc, Spatial QRS-T Angle and Ventricular Gradient|Different post-dose timepoints employ different techniques for altering heart rate (leg raises and postural maneuvers). Using this data a model for different ECG parameters (same as for primary analysis) and heart rate will be developed. The model will either be a linear or non-linear model (as determined by visual inspection), but the model will be the same for all subjects and maneuvers. The model coefficients for different maneuvers and drugs will be compared.|24 hours||06/2016||||
659812|NCT01873950|Primary|Placebo, and Baseline-adjusted Changes in PR, QRS, J-Tpeak, Tpeak-Tend and QTc|Compute maximum mean placebo, and baseline-adjusted change for: PR (ms), QRS (ms), J-Tpeak (ms), Tpeak-Tend (ms) and QTc (ms)|24 hours|||ms||95% Confidence Interval|Least Squares Mean
659813|NCT01873859|Primary|Change of Baseline Creatinine 48 hr After Recieving Contrast Media in the Presence or Absence of Metformin Use.||48 hours from the baseline|||mg/dl||Standard Deviation|Mean
659814|NCT01873859|Primary|Incidence of Lactic Acidosis|Metformin-associated lactic acidosis (MALA) was defined as an arterial pH <7.35 and plasma lactate concentration >5 mmol ⁄ L.|48 hrs|||participants|||Number
659815|NCT01873729|Secondary|Clinical Global Impression (CGI)|The Clinical Global Impression (CGI) scale allows the clinician to rate the severity of illness, change over time, and efficacy of medication, taking into account the patient’s clinical condition and the severity of side effects. The CGI subscales include the Clinical Global Severity of ADHD (CGI-S) which is scored on a 7 point scale (1=not ill, 7=extremely ill) and the Clinical Global Improvement of ADHD (CGI-I) which is also scored on a 7 point scale (1=very much improved, 7=very much worse). The number of subjects with CGI-Improvement scores less than or equal to 2 (very much improved) at the end of the study is reported.|Six weeks|||Participant|||Number
659816|NCT01873729|Primary|Change in Adult Investigator Symptom Rating Scale (AISRS) Scores From Baseline|The Adult Investigator Symptom Rating Scale (AISRS) is an 18-item clinician rating scale to evaluate individual ADHD symptoms on a scale of 0 (none) to 3 (severe). The total sum ranges from 0 (no ADHD symptoms) to 54 (extremely severe ADHD symptoms).|Baseline and Six weeks|||Units on a scale||Standard Deviation|Mean
659817|NCT01873417|Secondary|Number of DMF-treated Participants Who Discontinued DMF Due to GI-related Events Requiring Symptomatic Therapy|The last symptomatic therapy prior to last dose of study medication was used to summarize the number of participants who discontinued DMF due to GI-related events. Participants may have taken more than one symptomatic therapy but are counted only once in the 'All Therapies' category.|12 Weeks|Safety Population (participants who received at least 1 dose of DMF, recorded in diary data)||participants|||Number
659818|NCT01873417|Secondary|Summary of Use and Days on Symptomatic Therapy, by Category|The total duration (in days) of use of each symptomatic therapy by participants as a result of GI symptoms experienced by DMF-treated participants is presented. If a participant had multiple different therapies on the same day, the days on symptomatic therapy was calculated as 1 day in the 'All Therapies' category.|12 Weeks|Evaluable participants (treated participants who utilized symptomatic therapy during the overall treatment period [12 weeks]). n= number of participants using the therapy specified.||days||Standard Deviation|Mean
659819|NCT01873417|Secondary|Participants' Use of Symptomatic Therapy, by Type and Category|The symptomatic therapies used by DMF-treated participants were self-reported by type and category. Each participant may have taken more than one symptomatic therapy type but was counted only once within each therapy category. Acetylsalicylic acid (ASA) is abbreviated in the table.|12 Weeks|Safety Population (participants who received at least 1 dose of DMF, recorded in diary data)||participants|||Number
659821|NCT01873417|Primary|Duration of GI-related Episodes in DMF-treated Participants|In participants who took symptomatic therapy, the median duration of acute GI episodes (in hours) was summarized for the overall treatment period, by symptom (nausea, diarrhea, lower abdominal pain, upper abdominal pain, vomiting, indigestion, constipation, bloating, and flatulence). Table only includes the symptom duration for those symptoms with start and stop times entered in the eDiary (evaluable GI episodes), based on the MAGISS.|12 Weeks|Evaluable participants (treated participants who utilized symptomatic therapy during the overall treatment period [12 weeks]); n=number of participants with evaluable GI symptom specified.||hours||Full Range|Median
659822|NCT01873417|Primary|Percentage of DMF-treated Participants Who Reported GI-related Symptoms and Who Utilized Symptomatic Therapy|Percentage of participants reporting GI symptoms on the MOGISS, by those who utilized symptomatic therapy.|12 Weeks|Safety Population (participants who received at least 1 dose of DMF, recorded in diary data)||percentage of participants|||Number
659823|NCT01873417|Primary|Worst Severity Score of Overall GI Events, Modified Acute Gl Symptom Scale|Severity of GI-related events in DMF-treated participants using the MAGISS to measure GI symptoms, based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms.|12 Weeks|Evaluable participants (treated participants who utilized symptomatic therapy during the overall treatment period [12 weeks]).||units on a scale||Standard Deviation|Mean
659824|NCT01873417|Primary|Worst Severity Score of Overall Gastrointestinal (GI) Events, Modified Overall GI Symptom Scale (MOGISS)|Severity of GI-related events in DMF-treated participants using the MOGISS to measure GI symptoms, based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms.|12 Weeks|Evaluable participants (treated participants who utilized symptomatic therapy during the overall treatment period [12 weeks]).||units on a scale||Standard Deviation|Mean
659825|NCT01872819|Secondary|Change in the Rate of Complete Response, Defined by Criteria of Cheson et al.||Baseline up to 2 years||||||
659826|NCT01872819|Primary|Achievability of Performing Individualized Drug Screening and Initiating Therapy Based on the Results of the Drug Screen for Poor Risk Patients With Relapsed or Refractory AML|Whether treatment was administered in the time frame based on the high throughput drug screen. Time from sample procurement to assay results.|Up to 21 days|15 patients were treated.||days||Full Range|Median
659827|NCT01872715|Secondary|Patient Satisfaction Question|The patient satisfaction question was answered by the subject at week 2, week 6, and week 12. The subject was asked how satisfied they were with this treatment (doxycycline MR) for rosacea.|Week 2, 6, and 12|||participants|||Number
659828|NCT01872715|Secondary|Patient Global Assessment (PGA) of Rosacea Scores|Patient Global Assessment (PGA) of Rosacea: 0 = clear, no signs or symptoms present; 1 = Near clear, 1 or 2 papules; 2 = mild, some (3 to 10) papules/pustules; 3 = moderate, moderate (11 to 19) number of papules and pustules; 4 = severe, numerous (≥ 20) papules/pustules; nodules|Baseline, Weeks 2, 6, and 12|||participants|||Number
659829|NCT01872715|Secondary|Rosacea-Specific Quality of Life Index|ROSACEA-SPECIFIC QUALITY OF LIFE INDEX©: average of scores to 22 questions on a 5 point scale (1 = never, 5 = all the time)|Baseline, Weeks 2, 6, and 12|Intent-to-Treat (ITT) population: All subjects who were enrolled and had at least 1 posttreatment administration evaluation. This is the primary population for efficacy analyses.||units on a scale||Standard Deviation|Mean
659830|NCT01872715|Primary|Rosacea Score on the Visual Analog Scale|VAS = visual analog scale, 10 cm scale in which 0 = no rosacea, 10 = worst rosacea imaginable|Baseline, Weeks 2, 6, and 12|Intent-to-Treat (ITT) population: All subjects who were enrolled and had at least 1 posttreatment administration evaluation. This is the primary population for efficacy analyses.||units on a scale||Standard Deviation|Mean
659831|NCT01872611|Secondary|Percentage of Participants With With a > 10-letter Loss in BCVA From Day 7 to Any Visit||Day 7 up to any visit through Day 90|Full analysis set||percentage of participants|||Number
659832|NCT01872611|Secondary|Percentage of Participants With a > 5-letter Loss in BCVA From Day 7 to Any Visit||Day 7 up to any visit through Day 90|Full analysis set||percentage of participants|||Number
659833|NCT01872611|Secondary|Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 60||Baseline to Day 60|Full analysis set||Percentage of participants|||Number
659834|NCT01872611|Secondary|Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 90||Baseline to Day 90|Full analysis set||Percentage of participants|||Number
659835|NCT01872611|Primary|Percentage of Participants Who Develop Macular Edema Within 90 Days Following Cataract Surgery (Day 0)|Macular edema was defined as ≥ 30% Increase from pre-operative baseline in central subfield macular thickness, as measured with Spectral Domain Ocular Coherence Tomography (SD-OCT). One eye (study eye) contributed to the analysis.|Day 0 to Day 90|Full analysis set||Percentage of participants|||Number
659836|NCT01872611|Primary|Percentage of Participants With Best-corrected Visual Acuity (BCVA) Improvement of ≥ 15 Letters From Preoperative Baseline to Day 14 and Maintained Through Day 90|BCVA (with spectacles or other visual corrective devices) was reported in letters read correctly, using the Early Treatment Diabetic Retinopathy Study (ETDRS) test of 70 letters. Improvement of BCVA was defined as an increase (gain) in the number of letters read, compared to the baseline assessment. One eye (study eye) contributed to the analysis.|Baseline to Day 14, and maintained through Day 90|Full analysis set||Percentage of participants|||Number
659837|NCT01872078|Primary|Lutenising Hormone (LH) AUC(0-8) Ratio to Baseline at Day 7|Change-from-baseline of luteinising hormone area under the concentration-time curve from time zero to 8 hours postdose [AUC(0-8)] at Day 7|Day 7|||Ratio||95% Confidence Interval|Geometric Mean
659838|NCT01871870|Secondary|Deviation From Target Blood Glucose|Assessment of how accurately the algorithm controls glycemia in the subjects will be carried out using the mean deviation from the target blood glucose (mg/dL). Deviation is measured as algorithm controlled glucose level minus target glucose level.|28 hours|||mg/dl||Standard Deviation|Mean
659839|NCT01871870|Primary|Verification of the Automation and Telemetry Components|This outcome will verify afferent signal transmittal from the Dexcom sensors to the algorithm and the efferent signal transmittal from the algorithm to the insulin and glucagon pumps. Outcome measure is the average number of sensor and/or pump telemetry failures per 28 hour study.|28 hours|||failures||Standard Deviation|Mean
659885|NCT01871532|Secondary|Percentage of Cycles With Bifollicular Development|The bifollicular development was defined as the number of cycles with bifollicular development of only two follicles greater than or equal to 17 millimeter.|Baseline up to 4 weeks|Data was not assessed since the study was terminated early due to the delay in providing additional study drug following a batch recall.|||||
659865|NCT01871558|Secondary|Percent of Participants That Reach Therapeutic Goal (HbA1c ≤ 7%) at Week 24 Without Any Hypoglycaemic Episode (Symptomatic or Not) and Without Any Weight Gain (Variation ≥3% Compared to Baseline)|HbA1c <= 7% without any hypoglycaemic episode (symptomatic or not) and without any weight gain|week 24|ITT population||percent of participants|||Number
659866|NCT01871558|Secondary|Percentage of Patients With Severe and Confirmed Hypoglycemic Events|Severe hypoglycemic events (and number of events) , defined as events requiring assistance of a third party, and with confirmed hypoglycemic events (and number of events) defined as events with concomitant self monitoring of blood glucose (SMBG) < 70 mg/dL|24 weeks|ITT population||percent participants|||Number
659867|NCT01871558|Secondary|Mean Daily Insulin Dose at Week 24||Week 24|ITT population||(U/d)||Standard Deviation|Mean
659868|NCT01871558|Secondary|Change From Baseline in Body Weight in Both Treatment Arms||Baseline, Week 24|Safety Population||kg||Standard Deviation|Mean
659869|NCT01871558|Secondary|Change From Baseline in HbA1c to Week 24 in Both Treatment Arms||Baseline, Week 24|ITT population||HbA1c percent||Standard Deviation|Mean
659870|NCT01871558|Secondary|Percentage of Patients Reaching Their Glycemic Target Without Hypoglycemic Events|Glycemic target is defined as Glycated hemoglobin(HbA1c) ≤ 7%|24 weeks|ITT population||percent of participants|||Number
659871|NCT01871558|Primary|Percentage of Patients Who Reported at Least One Symptomatic Hypoglycemic Event During the 24 Week Randomized Period in Both Treatment Arms||24 weeks|safety population||percent of participants|||Number
659872|NCT01871532|Secondary|Sex Hormone Binding Globulin (SHBG) Levels||Baseline|Data was not assessed since the study was terminated early due to the delay in providing additional study drug following a batch recall.|||||
659873|NCT01871532|Secondary|Testosterone Levels||Baseline|Data was not assessed since the study was terminated early due to the delay in providing additional study drug following a batch recall.|||||
659874|NCT01871532|Secondary|Change From Baseline in Anti-Mullerian Hormone (AMH) Levels at Week 4||Baseline, Week 4|Data was not assessed since the study was terminated early due to the delay in providing additional study drug following a batch recall.|||||
659875|NCT01871532|Secondary|Total Dose of Recombinant Follicle Stimulating Hormone (r-FSH) Administered Per Cycle||Baseline up to 4 weeks|Data was not assessed since the study was terminated early due to the delay in providing additional study drug following a batch recall.|||||
659876|NCT01871532|Secondary|Duration of Recombinant Follicle Stimulating Hormone (rFSH) Stimulation||Baseline up to 4 weeks|Data was not assessed since the study was terminated early due to the delay in providing additional study drug following a batch recall.|||||
659877|NCT01871532|Secondary|Number of Subjects With Ovarian Hyper Stimulation Syndrome (OHSS)|OHSS was defined as an exaggerated systemic response to ovarian stimulation characterized by a wide spectrum of clinical and laboratory manifestations, classified as mild, moderate or severe according to the degree of abdominal distention, ovarian enlargement and respiratory, hemodynamic and metabolic complications.|up to 42 days post hCG administration|Safety population included all subjects who were randomised and received at least 1 Gonal-f injection.||subjects|||Number
659878|NCT01871532|Secondary|Number of Miscarriages After Confirmation of Clinical Pregnancy|Miscarriages were calculated per clinical pregnancy, and clinical pregnancy was defined as pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or confirmed by clinical signs of pregnancy. It excludes ectopic pregnancy.|35-42 days post hCG administration|Data was not assessed since the study was terminated early due to the delay in providing additional study drug following a batch recall.|||||
659879|NCT01871532|Secondary|Number of Fetuses||35-42 days post hCG administration|Data was not assessed since the study was terminated early due to the delay in providing additional study drug following a batch recall.|||||
659880|NCT01871532|Secondary|Number of Multiple Pregnancy|Multiple pregnancy is a pregnancy where more than one fetus develops simultaneously in the womb. There are two types of twinning—identical and fraternal. Identical twins represent the splitting of a single fertilized zygote (union of two gametes or male/female sex cells that produce a developing fetus) into two separate individuals.|35-42 days post hCG administration|Data was not assessed since the study was terminated early due to the delay in providing additional study drug following a batch recall.|||||
659881|NCT01871532|Secondary|Percentage of Cycles Resulting in Clinical Pregnancy|Clinical pregnancy was defined as pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It excludes ectopic pregnancy.|35-42 days post hCG administration|Data was not assessed since the study was terminated early due to the delay in providing additional study drug following a batch recall.|||||
659882|NCT01871532|Secondary|Percentage of Cycles Wherein Human Chorionic Gonadotropin (hCG) Was Not Administered||Baseline up to 4 weeks|Data was not assessed since the study was terminated early due to the delay in providing additional study drug following a batch recall.|||||
659883|NCT01871532|Secondary|Percentage of Ovulatory Cycles|Ovulation was defined as a serum progesterone (P4 ) level greater than or equal to 10 nanogram per milliliter (ng/mL) or Clinical Pregnancy. Clinical pregnancy was defined as pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It excludes ectopic pregnancy.|Baseline up to 42 days post human chorionic gonadotrophin (hCG) administration|Data was not assessed since the study was terminated early due to the delay in providing additional study drug following a batch recall.|||||
659994|NCT01869686|Secondary|Ratio of Maximum Seminal Fluid Concentration by the Serum Concentration (Cmax Ratio)|The ratio of maximum denosumab seminal fluid concentration over the denosumab serum concentration at the corresponding time point (Cmax Ratio)|Days 1, 10, 22, 36, 50, 78 and 106|Pharmacokinetic population with available data||ratio||Standard Deviation|Mean
659886|NCT01871532|Primary|Percentage of Cycles With Monofollicular Development|The monofollicular development was defined as the number of cycles with monofollicular development only one Follicle Greater Than or Equal (>= to 17 millimeter (mm) and no other follicles Greater than or equal to 14 mm following up to 4 weeks Gonal-f treatment.|Baseline up to 4 weeks|Data was not assessed since the study was terminated early due to the delay in providing additional study drug following a batch recall.|||||
659887|NCT01871519|Secondary|Neurological Success Rate|Neurological functions were assessed preoperatively and postoperatively. Each of the individual functions was comprised of a number of elements. Investigators evaluated whether observations in each function category was normal or abnormal, and documentation of abnormal findings were required for each element in that function. Success for each component was defined as maintenance or improvement from preoperative for all elements. Success for overall neurologic status was defined as successful in all components.|Pre-discharge, 30 days, 3 months, 6 months, and 12 months|The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.||percentage of participants|||Number
659888|NCT01871519|Secondary|Subsequent Radiographic Fractures|A subsequent VCF was defined as any fracture at an index or non-index vertebral body occurring after the initial procedure as compared to baseline. The percentage of subjects having one or more subsequent VCFs is presented.|3 months and 12 months|The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.||percentage of participants|||Number
659889|NCT01871519|Secondary|Local Cobb Angle|The local Cobb angle (LCA) was defined as the angle formed by lines drawn parallel to the superior endplate of the vertebral body above and the inferior endplate of the vertebral body below.|Baseline, pre-discharge, 3 months, and 12 months|A total of 490 treated levels in 344 subjects were included in LCA analysis. The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.||degrees|Treated levels|Standard Deviation|Mean
659890|NCT01871519|Secondary|Vertebral Body Angle|The vertebral body kyphosis angle (VBA) was defined as the angle formed by lines drawn parallel to the caudal and cranial fractured vertebral body endplates.|Baseline, pre-discharge, 3 months, and 12 months|A total of 490 treated levels in 344 subjects were included in VBA analysis. The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.||degrees|Treated levels|Standard Deviation|Mean
659891|NCT01871519|Secondary|Vertebral Body Height Restoration (Absolute Height Restored as Percent, AHRP)|AHRP (Absolute height restored as percent) was the amount of height restored in the vertebral body expressed as a percent of estimated pre-fracture (EP) height. Measurements were assessed at anterior, medial, and posterior locations on the vertebral body.|Baseline, pre-discharge, 3 months, and 12 months|A total of 490 treated levels in 344 subjects were included in vertebral body height restoration analysis. The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.||percentage of pre-fracture height|Treated levels|Standard Deviation|Mean
659892|NCT01871519|Secondary|Karnofsky Performance Scale|For subjects with cancer, the Karnofsky performance scale was used for rating subject activities of daily living.The Karnofsky performance scale rates a subject on an 11-step scale from 0 (dead) to 100 (normal, no complaints, no evidence of disease), and a score of 70 is a clinically meaningful threshold for self-care.|Baseline, 30 days, 3 months 6 months, and 12 months|The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.||units on a scale||Standard Deviation|Mean
659893|NCT01871519|Secondary|Barthel Index (Only for Subjects With Osteoporosis)|For subjects with osteoporosis, the Barthel index was used for rating subject activities of daily living on a scale from 0 (maximum disability) to 20 (no disability).|Baseline, 30 days, 3 months 6 months, and 12 months|The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.||units on a scale||Standard Deviation|Mean
659894|NCT01871519|Secondary|Ambulatory Status||Baseline, 7 days, 30 days, 3 months, 6 months, 9 months, and 12 months|The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.||percentage of participants|||Number
659895|NCT01871519|Secondary|The Number of Days With Limited Activities and Bed Rest Due to Back Pain in the Previous 2 Weeks;||Baseline, 30 days, 3 months, 6 months, and 12 months|The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.||days||Standard Deviation|Mean
659896|NCT01871519|Secondary|Percentage of Subjects Having Daily Living Activities Limited Due to Back Pain in the Previous 2 Weeks||Baseline, 30 days, 3 months, 6 months, and 12 months|The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.||percentage of participants|||Number
659897|NCT01871519|Secondary|Quality of Life by EQ-5D Index Score||Baseline, 30 days, 6 months, and 12 months|The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.||units on a scale||Standard Deviation|Mean
659898|NCT01871519|Secondary|Quality of Life by SF-36v2 PCS|Quality of life was assessed by Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) version 2.0. The SF-36 v2 physical component summary (PCS) score is between 0 and 100, with higher scores denoting better quality of life.|Baseline, 30 days, 6 months, and 12 months|The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.||units on a scale||Standard Deviation|Mean
659899|NCT01871519|Secondary|Back Function (ODI)|ODI Questionnaire was used to assess patient back function. The ODI score ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability).|Baseline, 30 days, 6 months, and 12 months|The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.||units on a scale||Standard Deviation|Mean
659900|NCT01871519|Secondary|Back Pain|"Back pain was measured using NRS. Patients rated their back pain on a scale from 0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be."|Baseline, 7 days, 30 days, 6 months, 9 months, and 12 months|The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.||units on a scale||Standard Deviation|Mean
659901|NCT01871519|Primary|Change From Baseline in Quality of Life by the EQ-5D Index at 3 Months|EQ-5D index scores range from 0 to 1.0 on a scale where 0 = death and 1.0 = perfect health.|Baseline, 3 months after surgery|The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.||units on a scale||Standard Deviation|Mean
659902|NCT01871519|Primary|SF-36v2 Physical Component Summary Change From Baseline at 3 Months|Quality of life was assessed by Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) version 2.0. The SF-36 v2 physical component summary (PCS) score is between 0 and 100, with higher scores denoting better quality of life.|Baseline, 3 months after surgery|The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.||units on a scale||Standard Deviation|Mean
659903|NCT01871519|Primary|Back Function Change From Baseline by Oswestry Disability Index at 3 Months|ODI Questionnaire was used to assess patient back function. The ODI score ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability).|Baseline, 3 months after surgery|The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.||units on a scale||Standard Deviation|Mean
659904|NCT01871519|Primary|Back Pain Change From Baseline at 3 Months|"Back pain was measured using NRS. Patients rated their back pain on a scale from 0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be."|Baseline, 3 months after surgery|The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.||units on a scale||Standard Deviation|Mean
659905|NCT01871402|Other Pre-specified|Change in % Body Surface Area (BSA) With Active Psoriasis at Days 8 and 15|The investigator will use the assumption that 1% BSA is approximately equal to the surface area of the subject’s palm and fingers, with the fingers extended yet grouped together, creating a flat oval-like surface area.|Baseline, Day 8 and Day 15|Analysis shown is based on the ITT population at Days 8 and 15 and compared to baseline. Number of Participants Analyzed is at Day 15; at Day 8, N=109 (Active) and N=110 (Vehicle). Only participants with observed values are reported.||Change in %BSA||Standard Deviation|Mean
659906|NCT01871402|Other Pre-specified|Change From Baseline in Pruritus Score at Day 15|Pruritus scale will be used to assess the subjective and multidimensional experience of the subject’s pruritus (itching) during the previous two weeks at Baseline and Day 15. Possible scores range from 5 (no pruritus) to 25 (most severe pruritus).|Baseline and Day 15|Analysis shown is based on the ITT population. Only participants with observed values are reported.||units on a scale||Standard Deviation|Mean
659907|NCT01871402|Other Pre-specified|Proportion of Subjects Rated a “Treatment Success” for Each of the Clinical Signs of Psoriasis at Day 8|"Interim analysis of clinical signs of psoriasis (scaling, erythema and plaque elevation). Treatment success and clinical signs as defined in the secondary outcome measure."|Day 8|Analysis shown is based on the ITT population. Only participants with observed values are reported.||percentage of participants|||Number
659908|NCT01871402|Other Pre-specified|Proportion of Subjects With IGA “Treatment Success” at Day 8|"Interim analysis of IGA. Treatment success and IGA as defined in the primary outcome measure."|Day 8|Analysis shown is based on the ITT population. Only participants with observed values are reported.||percentage of participants|||Number
659909|NCT01871402|Secondary|"Proportion of Subjects Rated a Treatment Success for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation)"|"A static assessment of the overall or “average” degree of severity of each of three key characteristics present within all of the subject’s psoriatic lesions. Treatment success is defined as a score of 0 or 1 representing cleared or almost cleared at Day 15 with at least a two grade decrease in severity score relative to Baseline. Each clinical sign of psoriasis is measured on a 5-point scale, ranging from 0 (clear) to 4 (severe/very severe)."|Day 15|Analysis shown is based on the ITT population.||percentage of participants|||Number
659910|NCT01871402|Primary|"Proportion of Subjects Rated a Treatment Success Based on the Investigator's Global Assessment (IGA)"|"The IGA score is a static evaluation of the overall or average degree of severity of a subject's disease, taking into account all of the subject's psoriatic lesions. Treatment success is defined as a score of 0 or 1 representing cleared or almost cleared at Day 15 with at least a two grade decrease in severity score relative to Baseline. IGA is measured on a 5-point scale, ranging from 0 (clear) to 4 (severe/very severe)."|Day 15|Analysis shown is based on the Intent-to-Treat population, defined as all enrolled participants who were randomized and applied at least one dose of the test article.||percentage of participants|||Number
659922|NCT01870999|Secondary|Clinical Global Impression-Improvement Scale (CGI-I) at Week 12 and Week 24|"The participant's overall improvement was rated for each participant using the CGI-I scale. The investigator rated the participant's total improvement by answering the following question: Compared to his/her condition at baseline (prior to randomization), how much has the patient changed? using an 8-point scale where 0=not assessed, 1=very much improved to 7=very much worse. Lower scores indicated improvement."|Baseline, Week 12, Week 24|All randomized participants with data available at the given time-point were included in this analysis population.||units on a scale||Standard Deviation|Mean
662326|NCT01824446|Primary|Plasma Half-Life (T1/2) of Radiolabelled SSP-004184|The time it takes for the blood plasma concentration of a substance to halve.|Up to 288 hours post-dose|PAS||hours||Standard Deviation|Mean
659911|NCT01871285|Primary|Change From Baseline in Maximum COWS Total Score|Investigator-rated COWS scores range 0 to 4 or 5 on 11 items related to opiate withdrawal signs or symptoms; total score range 0 to 48 where 0-4 = no withdrawal and 5-12 = mild, 13-24 = moderate, 25-36 = moderately severe, more than 36 = severe withdrawal. The change from baseline in maximum COWS total score is determined as the difference between the maximum COWs total score and the baseline COWs total score.|Pre-dose (-0.5; baseline), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 12.5, 13, 13.5, 14, 16, and 24 (or end of study visit) hours post 1st study drug dose on each day of administration (period 1 [day 1] and period 2 [day 2]) in each treatment sequence|Analysis based on Per-protocol population (all randomized subjects who did not have major protocol deviations that might have confounded interpretation of the COWS [eg, received erroneous treatment], completed both crossover periods, and provided at least the first 4 hours of COWS data for each of 2 treatment periods); 4 subjects were excluded.||score||Standard Deviation|Mean
659912|NCT01871285|Primary|Maximum COWS Total Score|Investigator-rated COWS scores range 0 to 4 or 5 on 11 items related to opiate withdrawal signs or symptoms; total score range 0 to 48 where 0-4 = no withdrawal and 5-12 = mild, 13-24 = moderate, 25-36 = moderately severe, more than 36 = severe withdrawal. The maximum COWs total score is defined as the maximum COWs total score across all time points during the corresponding treatment period after study drug administration for each subject.|Pre-dose (-0.5), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 12.5, 13, 13.5, 14, 16, and 24 (or end of study visit) hours post 1st study drug dose on each day of administration (period 1 [day 1] and period 2 [day 2]) in each treatment sequence|Analysis based on Per-protocol population (all randomized subjects who did not have major protocol deviations that might have confounded interpretation of the COWS [eg, received erroneous treatment], completed both crossover periods, and provided at least the first 4 hours of COWS data for each of 2 periods); 4 subjects were excluded.||score||Standard Deviation|Mean
659913|NCT01871285|Secondary|Change From Baseline in “Pain Now” Over Time Using NRS|Subject rating of pain intensity using 11-point numerical rating scale (NRS) where 0=no pain and 10=pain as bad as you can imagine.|Pre-dose (-0.5; baseline), 0.5, 1, 2, 4, 9, 12, 12.5, 13, 14, 16, and 24 (or end of study visit) hours post 1st study drug dose on each day of administration (period 1 [day 1] and period 2 [day 2]) in each treatment sequence|Analysis based on Per-protocol population (all randomized subjects who did not have major protocol deviations that might have confounded interpretation of the COWS [eg, received erroneous treatment], completed both crossover periods, and provided at least the first 4 hours of COWS data for each of the 2 treatment periods); 4 subjects excluded.||units on a scale||Standard Deviation|Mean
659914|NCT01871285|Secondary|Change From Baseline in COWS Total Score Over Time|Investigator-rated COWS scores range 0 to 4 or 5 on 11 items related to opiate withdrawal signs or symptoms; total score range 0 to 48 where 0-4 = no withdrawal and 5-12 = mild, 13-24 = moderate, 25-36 = moderately severe, more than 36 = severe withdrawal.|Pre-dose (-0.5; baseline), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 12.5, 13, 13.5, 14, 16, and 24 (or end of study visit) hours post 1st study drug dose on each day of administration (period 1 [day 1] and period 2 [day 2]) in each treatment sequence|Analysis based on Per-protocol population (all randomized subjects who did not have major protocol deviations that might have confounded interpretation of the COWS [eg, received erroneous treatment], completed both crossover periods, and provided at least the first 4 hours of COWS data for each of 2 treatment periods); 4 subjects were excluded.||score||Standard Deviation|Mean
659915|NCT01871285|Primary|Number of Responders|A responder is defined as a subject whose maximum (across all time points) clinical opiate withdrawal scale (COWS) total score is ≥13. COWS scores range 0 to 4 or 5 on 11 items related to opiate withdrawal signs or symptoms; total score range 0 to 48 where 0-4 = no withdrawal and 5-12 = mild, 13-24 = moderate, 25-36 = moderately severe, more than 36 = severe withdrawal.|Pre-dose (-0.5), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 12.5, 13, 13.5, 14, 16, and 24 (or end of study visit) hours post 1st study drug dose on each day of administration (period 1 [day 1] and period 2 [day 2]) in each treatment sequence|Analysis based on Per-protocol population (all randomized subjects who did not have major protocol deviations that might have confounded interpretation of the COWS [eg, received erroneous treatment], completed both crossover periods, and provided at least the first 4 hours of COWS data for each of the 2 treatment periods); 4 subjects were excluded.||participants|||Number
659916|NCT01871142|Secondary|Secondary Objective Safety and Tolerability|To assess the safety and tolerability of single, escalating oral doses of Aes-103 compared with placebo in healthy adult men at rest and during stationary cycle ergometer exercise in normoxia and hypoxia by monitoring adverse events (AEs), electrocardiograms (ECGs), blood pressure, blood oxygen saturation.|AEs will be monitored at the time of visit and during the follow up period of 7 to 14 days.|||participants|||Number
659917|NCT01871142|Primary|Primary Objective Endurance Exercise Performance|To quantify endurance exercise performance (time trial performance during stationary cycle ergometer exercise) in healthy adult men in four conditions: normoxia (normal oxygen; fraction of inspired oxygen = 0.21) following oral placebo consumption, hypoxia (low oxygen; fraction of inspired oxygen = 0.15) following oral placebo consumption, hypoxia following oral consumption Aes-103 (1000 mg) and hypoxia following oral consumption Aes-103 (3000 mg).|The time trial will begin after 1 hour after consumption of the intervention or placebo under normoxic or hypoxic conditions.|||minutes||Standard Error|Mean
659918|NCT01871090|Other Pre-specified|Length of Emergency Department Stay|Defined as the time from the Emergency Department Check In Time until the Emergency Department Check Out Time (discharged/leaves Emergency Department or admitted to hospital).|On day of Emergency Department admission|||Minutes||Full Range|Median
659919|NCT01871090|Secondary|Time to Clinical/Treatment Decision|Defined as the time from the Emergency Department Check In Time until the first of: Time of Clinical/Treatment Decision or Emergency Department Check Out Time (discharged/leaves Emergency Department or admitted to hospital).|On day of Emergency Department admission|||Minutes||Full Range|Median
659920|NCT01871090|Primary|Time to Interrogation|Time to interrogation is defined as the time from Triage (decision to interrogate the device) until the first of: Completion of interrogation, Time of Clinical/Treatment decision, or Emergency Department check out time.|On day of Emergency Department admission|||Minutes||Full Range|Median
659921|NCT01870999|Secondary|"Number of Participants Hospitalized for Adverse Event Worsening Schizophrenia"|The number of participants hospitalized for the Adverse Event “Worsening Schizophrenia included all participants who were hospitalized for any Adverse Event pertaining to the exacerbation of schizophrenic symptoms.|7 Months|All randomized participants were included in the analysis population.||Participants|||Number
659923|NCT01870999|Secondary|Change From Baseline in the Clinical Global Impression- Severity of Illness Score (CGI-S) at Week 12 and Week 24|"The severity of illness for each participant was rated using the CGI-S scale. The investigator answered the following question: Considering your total clinical experience with this particular population, how mentally ill is the patient at this time? using an 8-point scale where 0=not assessed to 7=among the most extremely ill patients. A negative change from Baseline indicated improvement."|Baseline, Week 12, Week 24|All randomized participants with data available were included in this analysis population (LOCF).||units on a scale||Standard Deviation|Mean
659924|NCT01870999|Secondary|Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Negative Subscale Scores at Week 12 and Week 24|The PANSS Negative Subscale consisted of 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. Severity was rated on a 7-point scale where 1=absence of symptoms to 7=extremely severe symptoms. The total score on the Negative Subscale ranged from 7 to 49 with a higher score indicating more severe symptoms. A negative change from Baseline indicated improvement.|Baseline, Week 12, Week 24|All randomized participants with data available were included in this analysis population (LOCF).||units on a scale||Standard Deviation|Mean
659925|NCT01870999|Secondary|Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Positive Subscale Scores at Week 12 and Week 24|The PANSS Positive Subscale consisted of 7 symptom constructs: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. Severity was rated on a 7-point scale where 1=absence of symptoms to 7=extremely severe symptoms. The total score on the Positive Subscale ranged from 7 to 49 with a higher score indicating more severe symptoms. A Negative change from Baseline indicated improvement.|Baseline, Week 12, Week 24|All randomized participants with data available were included in this analysis population (LOCF).||units on a scale||Standard Deviation|Mean
659926|NCT01870999|Secondary|Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 12 and Week 24|The PANSS consisted of 3 subscales with a total of 30 symptom constructs each rated on a 7-point scale where 1=absence of symptoms to 7=extremely severe symptoms. The Positive Subscale consisted of 7 positive symptom constructs with a possible subscale score of 7 to 49, the Negative Subscale consisted of 7 negative symptom constructs with a possible subscale score of 7 to 49 and the General Psychopathology Subscale consisted of 16 symptom constructs for a possible subscale score of 16 to 112. The PANSS Total Score ranged from 30 (best) to 210 (worst; indicating more severe symptoms). A Negative change from Baseline indicated improvement.|Baseline, Week 12, Week 24|All randomized participants with data available were included in this analysis population-last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
659927|NCT01870999|Secondary|Dehydro-aripiprazole Maximum (Peak) Plasma Concentration (Tmax)|Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for dehydro-aripiprazole. Values for tmax were determined directly from the observed data during the dosing interval (0-1344 hours) after the fifth monthly injection.|Pre-dose and 1 to 1344 hours post-dose at Month 5|Participants who received at least 3 doses of study medication and had pharmacokinetic (pK) samples collected through at least 672 hours following the 3rd or 4th dose are included in the efficacy pK analysis set.||Day||Full Range|Median
659928|NCT01870999|Secondary|Dehydro-aripiprazole Area Under the Concentration-Time Curve at Steady-State (AUCτ)|Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for dehydro-aripiprazole. Values of AUCτ were estimated using the linear trapezoidal rule during each dosing interval from 0 to 1344 hours post-dose.|Pre-dose and 1 to 1344 hours post-dose at Month 5|Participants who received at least 3 doses of study medication and had pharmacokinetic (pK) samples collected through at least 672 hours following the 3rd or 4th dose are included in the efficacy pK analysis set.||μg*h/mL||Standard Deviation|Mean
659929|NCT01870999|Secondary|Dehydro-aripiprazole Minimum Steady State Plasma Concentration (Css,Min)|Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for dehydro-aripiprazole. Values for Css,min were determined directly from the observed data during the dosing interval (0-1344 hours) after the fifth monthly injection.|Pre-dose and 1 to 1344 hours post-dose at Month 5|Participants who received at least 3 doses of study medication and had pharmacokinetic (pK) samples collected through at least 672 hours following the 3rd or 4th dose are included in the efficacy pK analysis set.||ng/mL||Standard Deviation|Mean
659930|NCT01870999|Secondary|Dehydro-aripiprazole Maximum Steady State Plasma Concentration (Css,Max)|Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for dehydro-aripiprazole. Values for Css,max were determined directly from the observed data during the dosing interval (0-1344 hours) after the fifth monthly injection.|Pre-dose and 1 to 1344 hours post-dose at Month 5|Participants who received at least 3 doses of study medication and had pharmacokinetic (pK) samples collected through at least 672 hours following the 3rd or 4th dose are included in the efficacy pK analysis set.||ng/mL||Standard Deviation|Mean
659931|NCT01870999|Secondary|Aripiprazole Terminal-phase Elimination Half-life (t1/2,z)|Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for aripiprazole. Values for t1/2,z were determined directly from the observed data during the dosing interval (0-1344 hours) after the fifth monthly injection.|Pre-dose and 1 to 1344 hours post-dose at Month 5|Participants who received at least 3 doses of study medication and had pharmacokinetic (pK) samples collected through at least 672 hours following the 3rd or 4th dose are included in the efficacy pK analysis set. The analysis population for this outcome measure represents a sub-set who were evaluable for this measure at month 5.||Day||Standard Deviation|Mean
659977|NCT01869959|Secondary|Change From Baseline to Day 28 in Body Weight|Change from baseline to Day 28 in body weight is presented. The predose body weight measurement on Day 1 served as the baseline value. LS means were calculated using a linear mixed effects model with treatment, day, time, and treatment times time, treatment times day, and treatment times day times time were fixed effects; baseline as covariate; and participant as a random effect.|Baseline, Day 28|All participants who received at least 1 dose of study drug with evaluable body weight data.||kilograms (kg)||90% Confidence Interval|Least Squares Mean
659932|NCT01870999|Secondary|Aripiprazole Steady-state Plasma Concentration (Css,Avg)|Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for aripiprazole. Values for Css,avg were determined directly from the observed data during the dosing interval (0-1344 hours) after the fifth monthly injection.|Pre-dose and 1 to 1344 hours post-dose at Month 5|Participants who received study medication and had pharmacokinetic (pK) samples collected through at least 672 hours following the 5th dose are included in the efficacy pK analysis set. Data was missing for 1 patient in the 300 mg Aripiprazole IM Depot arm.||ng/mL||Standard Deviation|Mean
659933|NCT01870999|Secondary|Aripiprazole Maximum (Peak) Plasma Concentration (Tmax)|Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for aripiprazole. Values for tmax were determined directly from the observed data during the dosing interval (0-1344 hours) after the fifth monthly injection.|Pre-dose and 1 to 1344 hours post-dose at Month 5|Participants who received study medication and had pharmacokinetic (pK) samples collected through at least 672 hours following the 5th dose are included in the efficacy pK analysis set.||Day||Full Range|Median
659934|NCT01870999|Primary|Aripiprazole Area Under the Concentration-time Curve at Steady-state (AUCτ)|Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for aripiprazole. Values of AUCτ were estimated using the linear trapezoidal rule during each dosing interval from 0 to 1344 hours post-dose.|Pre-dose and 1 to 1344 hours post-dose at Month 5|Participants who received at least 3 doses of study medication and had pharmacokinetic (pK) samples collected through at least 672 hours following the 3rd or 4th dose are included in the efficacy pK analysis set. Data was missing for 1 patient in the 300 mg Aripiprazole IM Depot arm.||μg*h/mL||Standard Deviation|Mean
659935|NCT01870999|Primary|Aripiprazole Minimum Steady State Plasma Concentration (Css,Min)|Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for aripiprazole. Values for Css,min were determined directly from the observed data at 672 hours after the fifth monthly injection.|672 hours post-dose at Month 5|Participants who received at least 3 doses of study medication and had pharmacokinetic (pK) samples collected through at least 672 hours following the 5th dose are included in the efficacy pK analysis set. Data was missing for 1 patient in the 200 mg Aripiprazole IM Depot arm.||ng/mL||Standard Deviation|Mean
659936|NCT01870999|Primary|Aripiprazole Maximum Steady State Plasma Concentration (Css,Max)|Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for aripiprazole. Values for Css,max were determined directly from the observed data during the dosing interval (0-1344 hours) after the fifth monthly injection.|Pre-dose and 1 to 1344 hours post-dose at Month 5|Participants who received at least 3 doses of study medication and had pharmacokinetic (pK) samples collected through at least 672 hours following the 5th dose are included in the efficacy pK analysis set.||ng/mL||Standard Deviation|Mean
659937|NCT01870999|Primary|Number of Participants With Adverse Events as a Measure of Safety|Safety and tolerability was assessed by the number of participants with adverse events (AE). An AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a subject while enrolled in the study, whether or not it was considered drug-related by the investigator. Abnormal laboratory test findings were considered AEs if, in the opinion of the investigator, they represented an abnormal (ie, clinically significant) change from baseline for that individual participant.|7 Months|Participants who received at least one dose of study medication are included in the safety analysis set.||Participants|||Number
659938|NCT01870973|Primary|Percent of Patients With Success as Defined by no or Mild Pain as Analyzed on a VAS Scale and no Narcotic Use|"pain measurement as assessed on a visual analog scale and pain medication usage
definition of success = no or mild pain as analyzed on VAS scale and no narcotic use; analyzed by logistic regression
VAS scale is 0 to 170 mm with the higher numbers indicating more pain and less success."|each day for 5 days|||percentage of participants|||Number
659939|NCT01870921|Secondary|Major CV Events|Combination of CV death, MI, and stroke|12 months|||Participants|||Number
659940|NCT01870921|Primary|Serious Adverse Events Other Than Bleeding|SAEs except the blending events which have aleady been reported as SAEs.|12 months|||Participants|||Number
659941|NCT01870921|Primary|Bleeding Events|PLATO-defined fatal/life threatening, major, major+minor,major+minor+minimal|12 months|||Participants|||Number
659942|NCT01870856|Secondary|Stage 2: Change From Baseline in Ocular Discomfort Score (as Measured by SPEED) at 2 Weeks|This outcome measure was not evaluated since primary efficacy was not demonstrated.|Baseline, Week 2||||||
659943|NCT01870856|Primary|Stage 2: Percent of Eyes Experiencing at Least 1 Grade Reduction in LWE at 2 Weeks|This outcome measure was not evaluated since primary efficacy was not demonstrated.|Baseline, Week 2||||||
659944|NCT01870856|Primary|Stage 1: Percent of Eyes Experiencing at Least 1 Grade Reduction in LWE at 2 Weeks|LWE was measured by slit lamp evaluation of fluorescein and lissamine green staining of the upper eyelid. LWE was graded on a scale from 0 to 3, where 0=none and 3=severe. The percent of eyes experiencing at least a 1 grade reduction in LWE (from baseline) at the 2-week visit was compared between groups. One eye (study eye) contributed to the analysis.|Baseline, Week 2|This analysis population includes all randomized subjects who did not meet the critical deviation criteria as specified in the Deviations and Evaluability Plan. Denominator for percentages is the number of subjects with data available at both time points.||percentage of subjects|||Number
659962|NCT01870739|Primary|Change From Baseline in Distal Descending Aorta Distensibility at 52 Weeks|Cardiovascular magnetic resonance imaging (MRI) scans were obtained at baseline prior to randomization, at week 52 for the assessment of local aortic distensibility. Distal descending aorta distensibility was one of the 3 components for measuring local arota distensibility.|Baseline, 52 weeks|Pharmacodynamic (PD) analysis set: All patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data. Patients with both baseline and week 52 data were included in this analysis.||10^(-3) x mmHg^(-1)||Standard Error|Least Squares Mean
659993|NCT01869686|Secondary|Ratio of Seminal Fluid AUC by Serum AUC for the 106 Day Dosing Period|The ratio of denosumab seminal fluid AUC over denosumab serum AUC for the 106-day dosing period.|Days 1, 10, 22, 36, 50, 78 and 106|Pharmacokinetic population||ratio||Standard Deviation|Mean
659945|NCT01870843|Secondary|Remission Rate Based on Inventory of Depressive Symptomatology, Self-Report (QIDS-SR) up to Day 56|QIDS-SR contains 16 question regarding 9 Major depression disorder symptoms (sleep, weight, psychomotor changes, depressed mood, decreased interest, fatigue, guilt, concentration, and suicidal ideation). Each question is rated on a 4-point scale (range, 0 to 3). Total score is the sum of scores calculated by adding scores for each question and the interpretation is as follows: 0-5 (no depression likely); 6-10 (possibly mildly depressed); 11-15 (moderate depression); 16-20 (severe depression); 21-27 (very severe depression). Higher scores represent more severe depression symptoms data was obtained by Last observation carried forward (LOCF) method.|Day 7, Day 14, Day 28, Day 42 and Day 56|"Full Analysis Set Population included who received at least 1 dose of the study drug, and completed at least 1 assessment visit during the treatment period. Here n (Number of Participants Analyzed) signifies number of Participants who were evaluable for this outcome at given time point."||Percentage of participants||95% Confidence Interval|Number
659946|NCT01870843|Secondary|Remission Rate Based on Hamilton Anxiety Scale (HAM-A) up to Day 56|"HAM-A is a rating scale developed to quantify the severity of anxiety symptomatology. It consists of 14 items, each defined by a series of symptoms. Each item is rated on a 5 point scale, ranging from 0 (not present) to 4 (severe). Total score is calculated by adding the scores for each of the 14 items and the score ranges from 0 to 56. The interpretation of total scores are: 0 to 17 is considered to be mild, 18 to 25 mild to moderate, and 26 to 30 moderate to severe and 31 to 56 indicate very severe anxiety. Higher scores indicate worsening data was obtained by Last observation carried forward (LOCF) method."|Day 7, Day 14, Day 28, Day 42 and Day 56|"Full Analysis Set Population included who received at least 1 dose of the study drug, and completed at least 1 assessment visit during the treatment period. Here n (Number of Participants Analyzed) signifies number of Participants who were evaluable for this outcome at given time point."||Percentage of participants||95% Confidence Interval|Number
659947|NCT01870843|Secondary|Depression Response Rate Based on Montgomery-Asberg Depression Rating Scale (MADRS) up to Day 56|"The MADRS is a 10 item scale designed to measure depression severity. Each item is scored on a 7 point scale and the scores range from 0 = item not present/normal to 6 = severe/continuous presence of the symptoms. Total score is calculated by adding the scores for all the 10 items and ranges from 0 to 60. The interpretations of the scores are: 0 to 6= normal/symptom absent; 7 to 19= mild depression; 20 to 34= moderate depression; 35 to 60= severe depression data was obtained by Last observation carried forward (LOCF) method."|Day 7, Day 14, Day 28, Day 42 and Day 56|"Full Analysis Set Population included who received at least 1 dose of the study drug, and completed at least 1 assessment visit during the treatment period. Here n (Number of Participants Analyzed) signifies number of Participants who were evaluable for this outcome at given time point."||Percentage of participants||95% Confidence Interval|Number
659948|NCT01870843|Secondary|Change in Inventory of Depressive Symptomatology, Self-Report (QIDS-SR) Total Scores From Baseline up to Day 56|QIDS-SR contains 16 question regarding 9 Major depression disorder symptoms (sleep, weight, psychomotor changes, depressed mood, decreased interest, fatigue, guilt, concentration, and suicidal ideation). Each question is rated on a 4-point scale (range, 0 to 3). Total score is the sum of scores calculated by adding scores for each question and the interpretation is as follows: 0-5 (no depression likely); 6-10 (possibly mildly depressed); 11-15 (moderate depression); 16-20 (severe depression); 21-27 (very severe depression). Higher scores represent more severe depression symptoms.|Baseline, Day 7, Day 14, Day 28, Day 42 and Day 56|Full Analysis Set Population included who received at least 1 dose of the study drug, and completed at least 1 assessment visit during the treatment period.||Units on a scale||95% Confidence Interval|Mean
659949|NCT01870843|Secondary|Change in Hamilton Anxiety Scale (HAM-A) Total Scores From Baseline up to Day 56|"HAM-A is a rating scale developed to quantify the severity of anxiety symptomatology. It consists of 14 items, each defined by a series of symptoms. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe). Total score is calculated by adding the scores for each of the 14 items and the score ranges from 0 to 56. The interpretation of total scores are: 0 to 17 is considered to be mild, 18 to 25 mild to moderate, and 26 to 30 moderate to severe and above 30 indicate very severe anxiety. Higher scores indicate worsening."|Baseline, Day 7, Day 14, Day 28, Day 42 and Day 56|Full Analysis Set Population included who received at least 1 dose of the study drug, and completed at least 1 assessment visit during the treatment period.||Units on a scale||95% Confidence Interval|Mean
659950|NCT01870843|Secondary|Change in Montgomery-Asberg Depression Rating Scale (MADRS) Scores From Baseline up to Day 56|"The MADRS is a 10-item scale designed to measure depression severity. Each item is scored on a 7-point scale and the scores range from 0 = item not present/normal to 6 = severe/continuous presence of the symptoms. Total score is calculated by adding the scores for all the 10 items and it ranges from 0 to 60. The interpretations of the scores are: 0 to 6= normal/symptom absent; 7 to 19= mild depression; 20 to 34= moderate depression; more than 34= severe depression."|Baseline, Day 7, Day 14, Day 28, Day 42 and Day 56|Full Analysis Set Population included who received at least 1 dose of the study drug, and completed at least 1 assessment visit during the treatment period.||Units on a scale||95% Confidence Interval|Mean
659951|NCT01870843|Secondary|Treatment Improvement Rate at the End of Week 1 and Week 2|"Onset of effect is defined as the reduction rate greater than or equal to 20 percent change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total scores. The MADRS is a 10-item scale designed to measure depression severity. Each item is scored on 7-point scale, from 0 = not present/normal to 6 = severe/continuous presence of the symptoms and the total score (addition of all 10-items) ranges from 0 to 60. The interpretations of the scores are: 0 to 6= normal/symptom absent; 7 to 19= mild depression; 20 to 34= moderate depression; more than 34= severe depression."|Week 1 and Week 2|"Full Analysis Set Population included who received at least 1 dose of the study drug, and completed at least 1 assessment visit during the treatment period. Here n (Number of Participants Analyzed) signifies number of Participants who were evaluable for this outcome at given time point."||Participants|||Number
659963|NCT01870739|Primary|Change From Baseline in Proximal Descending Aorta Distensibility at 52 Weeks|Cardiovascular magnetic resonance imaging (MRI) scans were obtained at baseline prior to randomization, at week 52 for the assessment of local aortic distensibility. Proximal descending aorta distensibility was one of the 3 components for measuring local arota distensibility.|Baseline, 52 weeks|Pharmacodynamic (PD) analysis set: All patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data. Patients with both baseline and week 52 data were included in this analysis.||10^(-3) x mmHg^(-1)||Standard Error|Least Squares Mean
659952|NCT01870843|Secondary|Remission Rate Based on Montgomery-Asberg Depression Rating Scale (MADRS) up to Day 56|"Remission rate is defined as percentage of participants with MADRS total scores less than or equal to 10 at the endpoint (at week 8). The MADRS is a 10-item scale designed to measure depression severity. Each item is scored on 7-point scale, from 0 = not present/normal to 6 = severe/continuous presence of the symptoms and the total score (addition of all 10-items) ranges from 0 to 60. The interpretations of the scores are: 0 to 6= normal/symptom absent; 7 to 19= mild depression; 20 to 34= moderate depression; more than 34= severe depression."|Day 7, Day 14, Day 28, Day 42 and Day 56|"Full Analysis Set Population included who received at least 1 dose of the study drug, and completed at least 1 assessment visit during the treatment period. Here n (Number of Participants Analyzed) signifies number of Participants who were evaluable for this outcome at given time point."||Percentage of participants||95% Confidence Interval|Number
659953|NCT01870843|Primary|Change in Sheehan Disability Scale (SDS) From Baseline up to Day 56|"SDS is a composite of 3 self-rated items designed to measure the extent to which 3 major sectors in the participant's life are impaired by panic, anxiety, phobic, or depressive symptoms. The participant rates the extent to which his or her (1) work, (2) social life or leisure activities, and (3) home life or family responsibilities are impaired by his or her symptoms on a 10-point visual analog scale. To get a total score add up the 3 individual scores and the total score ranges from 0 = unimpaired to 30 = highly impaired. Higher scores indicate worsening."|Baseline, Day 14, Day 28, Day 42, and Day 56|"Full Analysis Set Population included who received at least 1 dose of the study drug, and completed at least 1 assessment visit during the treatment period. Here n (Number of Participants Analyzed) signifies number of Participants who were evaluable for this outcome at given time point."||Units on a scale||Standard Deviation|Mean
659954|NCT01870843|Primary|Change in Quality of Life Enjoyment and Satisfaction Questionnaire, Short Form (Q-LES-Q-SF) From Baseline up to Day 56|"Q-LES-Q-SF is a 14-item questionnaire in which each question is rated on a 5-point scale with scores ranging from 1 = very poor to 5 = very good. The total raw score is calculated by summing up the scores for the 14 items. The raw total score ranges from 14 to 70. The raw total score is transformed into a percentage maximum possible score using the following formula: (raw total score minus minimum score) divided by (maximum possible raw score minus minimum score). The minimum raw score on the Q-LES-Q-SF is 14, and the maximum score is 70. Lower score indicate worsening."|Baseline, Day 14, Day 28, Day 42 and Day 56|"Full Analysis Set Population included who received at least 1 dose of the study drug, and completed at least 1 assessment visit during the treatment period. Here n (Number of Participants Analyzed) signifies number of Participants who were evaluable for this outcome at given time point."||Units on a scale||Standard Deviation|Mean
659955|NCT01870739|Secondary|Number of Patients With Reported Adverse Events, Serious Adverse Events and Death|This outcome measure summarizes patients with any adverse events, serious adverse events and death.|12 weeks|Safety analysis set: All patients that received study drug||Patients|||Number
659956|NCT01870739|Secondary|Change From Baseline in Carotid-femoral Pulse Wave Velocity at 52 Weeks|For pulse wave velocity calculation, the pressure waveform at the femoral site (using a partially inflated custom blood pressure cuff) and the carotid site (using hand -held applanation tonometry) were measured simultaneously. Pulse wave analysis was performed on the central aortic pressure waveform as derived from the brachial pressure waveform recorded in a partially-inflated blood pressure cuff around the upper arm.|Baseline, 52 weeks|Pharmacodynamic (PD) analysis set: All patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data. Patients with both baseline and week 52 data were included in this analysis||meters per second (m/s)||Standard Error|Least Squares Mean
659957|NCT01870739|Secondary|Change From Baseline in Augmentation Index at 52 Weeks|Augmentation index (Alx) is the percentage of the central pulse pressure due to wave reflection.|Baseline, 52 weeks|Pharmacodynamic (PD) analysis set: All patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data. Patients with both baseline and week 52 data were included in this analysis||percent||Standard Error|Least Squares Mean
659958|NCT01870739|Secondary|Change From Baseline in Augmentation Pressure at 52 Weeks|Augmentation pressure is the added pressure during systole due to wave reflection.|Baseline, 52 weeks|Pharmacodynamic (PD) analysis set: All patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data. Patients with both baseline and week 52 data were included in this analysis.||mmHg||Standard Error|Least Squares Mean
659959|NCT01870739|Secondary|Change From Baseline in Central Blood Pressure at 52 Weeks|Central blood pressure was determined by measuring central systolic blood pressure , diastolic blood pressure and pulse pressure.|Baseline, 52 weeks|Pharmacodynamic (PD) analysis set: All patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data. Patients with both baseline and week 52 data were included in this analysis.||mmHg||Standard Error|Least Squares Mean
659960|NCT01870739|Secondary|Change From Baseline in Regional Aortic Pulse Wave Velocity at 52 Weeks|Cardiovascular magnetic resonance imaging (MRI) scans were obtained at baseline prior to randomization, at week 52 for the assessment of regional aortic pulse wave velocity.|Baseline, 52 weeks|Pharmacodynamic (PD) analysis set: All patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data. Patients with both baseline and week 52 data were included in this analysis.||meters per second (m/s)||Standard Error|Least Squares Mean
659961|NCT01870739|Secondary|Change From Baseline in Local Aortic Strain at 52 Weeks|Cardiovascular magnetic resonance imaging (MRI) scans were obtained at baseline prior to randomization, at week 52 for the assessment of local aortic strain. Local aortic strain was measured by assessing ascending aorta strain, proximal descending aorta strain and distal descending aorta strain.|Baseline, 52 weeks|Pharmacodynamic (PD) analysis set: All patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data. Patients with both baseline and week 52 data were included in this analysis.||percent||Standard Error|Least Squares Mean
659976|NCT01869959|Secondary|Change From Baseline to Day 28 in Adiponectin|Change from baseline to Day 28 in adiponectin is presented. The predose adiponectin measurement on Day 1 served as the baseline value. LS means were calculated using a linear mixed effects model with treatment, day, treatment times day as fixed effects, baseline as covariate, and participant as random effect.|Baseline, Day 28|All participants who received at least 1 dose of study drug with evaluable adiponectin data.||nanograms per milliliter (ng/mL)||90% Confidence Interval|Least Squares Mean
659964|NCT01870739|Primary|Change From Baseline in Ascending Aorta Distensibility at 52 Week|Cardiovascular magnetic resonance imaging (MRI) scans were obtained at baseline prior to randomization, at week 52 for the assessment of local aortic distensibility. Ascending aorta distensibility was one of the 3 components for measuring local arota distensibility.|Baseline, 52 weeks|Pharmacodynamic (PD) analysis set: All patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data. Patients with both baseline and week 52 data were included in this analysis.||10^(-3) x mmHg^(-1)||Standard Error|Least Squares Mean
659965|NCT01870596|Primary|Response Rate(CR/CRi) Rate|For descriptive purposes, the CR/CRi (complete response/Complete response with incomplete blood count recovery) rate will be reported at the end of the study separately for Arm A and Arm B. Responses are following definitions consistent with those published by Dohner H, Estey EH, Amadori S, et al. CR is defined as Bone marrow showing less than 5% myeloblasts with normal maturation of all cell lines, an ANC of at least 1000/μL and a platelet count of 100,000/μL, absence of blasts in peripheral blood, absence of identifiable leukemic cells in the bone marrow, clearance of disease-associated cytogenetic abnormalities, and clearance of any previously existing extramedullary disease. CRi: All CR criteria except for residual neutropenia (ANC < 1000/μL)|Up to 3 years|||participants|||Number
659966|NCT01870583|Primary|Cesarean Surgical Site Infection|Surgical site infection will follow CDC guidelines: A) Superficial incisional surgical site infection B) Deep incisional surgical site infection or C) Organ/space surgical site infection.|42 days after delivery|||Participants|||Count of Participants
659967|NCT01870388|Primary|PK: Area Under the Concentration Versus Time Curve From Zero to Infinity [AUC(0-∞)] of Baricitinib||Predose up to 48 h postdose|Participants who received 1 dose of study drug and had evaluable PK data.||nanograms*hour/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
659968|NCT01870388|Primary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of Baricitinib (LY3009104)||Predose up to 48 hours (h) postdose|Participants who received 1 dose of study drug and had evaluable PK data.||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
659969|NCT01869959|Secondary|Change From Baseline to Day 28 in The Patient Health Questionnaire (PHQ-9) Score|Change from baseline to Day 28 in the PHQ-9 total score is presented. Participants were asked to score the severity of depressive symptoms over the last 2 weeks. Items were scored 0 (not at all), 1 (several days), 2 (half of the days), or 3 (nearly every day). The total PHQ-9 score is the sum of the score for each item and range from 0 to 27. A score of 0 means low depression severity and a score of 27 means high depression severity. Depression severity will be given a quality rating based on the total PHQ-9 score, as follows: None (0-4); Mild (5-9); Moderate (10-14); Moderately severe (15-19); and Severe (20-27). The PHQ-9 measurement obtained on Day -2 served as the baseline value. LS means were calculated using an analysis of covariance model with treatment, day, and treatment times day as fixed effects, and baseline as covariate.|Baseline, Day 28|All participants who received at least 1 dose of study drug with evaluable PHQ-9 data.||units on a scale||90% Confidence Interval|Least Squares Mean
659970|NCT01869959|Secondary|Change From Baseline to Day 28 in the Food Preference Questionnaire (FPQ) Score|The table below represents the change from baseline in FPQ total score. The FPQ was administered to assess overall preference for foods of different macronutrient contents utilizing a macronutrient self-selection paradigm. Participants rated their preference on a range from 1 to 9 with 1 (dislike extremely) to 9 (like extremely) for a battery of 72 commonly consumed foods with fat content varying significantly in sugar, complex carbohydrates, and protein. The total score was calculated by averaging preference scores of 72 items. A low mean score of 1 to 9 scale indicate a low preference for the foods listed and a high mean score indicate a high preference for the foods listed. The FPQ measurement on Day -2 served as the baseline value. LS means were calculated using an analysis of covariance model with treatment, day, and treatment times day as fixed effects, and baseline as covariate.|Baseline, Day 28|All participants who received at least 1 dose of study drug with evaluable FPQ data.||units on a scale||90% Confidence Interval|Least Squares Mean
659971|NCT01869959|Secondary|Change From Baseline to Day 28 in Eating Inventory for Cognitive Restraint of Eating, Disinhibition, and Hunger|Change from baseline to Day 28 in Eating Inventory (EI) subscales are presented. The EI is a 51-item inventory that measures dietary restraint (the cognitive intention to restrict energy intake; scores range from 0 to 21), disinhibition (the tendency to episodically overeat, often in response to external cues; scores range from 0 to 16), and perceived hunger (scores range from 0 to 14). A low score indicates a low exhibition of behavior and a high score indicates a high exhibition of behavior. The measurement for each variable obtained on Day -2 served as the baseline value. LS means were calculated using an analysis of covariance model with treatment, day, and treatment times day as fixed effects, and baseline as covariate.|Baseline, Day 28|All participants who received at least 1 dose of study drug with evaluable EI data.||units on a scale||90% Confidence Interval|Least Squares Mean
659972|NCT01869959|Secondary|The Number of Participants With Anti-LY2405319 Antibodies|The number of participants that tested positive for anti-LY2405319 antibodies is presented.|Day 1 through Day 56|All participants who received at least 1 dose of study drug with evaluable anti-LY2405319 antibody data.||number of participants|||Number
659973|NCT01869959|Secondary|Pharmacokinetics: Maximum Concentration (Cmax) of LY2405319|Cmax of LY2405319 is presented. Blood samples were collected predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, and 48 hours postdose on Day 28.|Predose through Day 28 (48 hours postdose)|All participants who received at least 1 dose of study drug with evaluable Cmax of LY2405319 data.||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
659974|NCT01869959|Secondary|Pharmacokinetics: Area Under the Concentration Time Curve (AUC) of LY2405319|AUC for LY2405319 is presented. Data represent AUC for 1 dosing interval at steady state. Blood samples were collected predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, and 48 hours postdose on Day 28.|Predose through Day 28 (48 hours postdose)|All participants who received at least 1 dose of study drug with evaluable AUC of LY2405319 data.||nanograms*hours/milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
659975|NCT01869959|Secondary|Change From Baseline to Day 28 in C-Reactive Protein|Change from baseline to Day 28 in C-reactive protein is presented. The predose C-reactive protein measurement on Day 1 served as the baseline value. LS means were calculated using a linear mixed effects model with treatment, day, and treatment times day as fixed effects; baseline as covariate; and participant as random effect.|Baseline, Day 28|All participants who received at least 1 dose of study drug with evaluable C-reactive protein data.||milligrams per liter (mg/L)||90% Confidence Interval|Least Squares Mean
659978|NCT01869959|Secondary|Change From Baseline to Day 28 in Fasting Lipid Profile|Change from baseline to Day 28 in fasting lipids, including cholesterol, low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C), and triglycerides is presented. The predose measurement for each variable on Day 1 served as the baseline value. LS means were calculated using a linear mixed effects model with treatment, day, and treatment times day as fixed effects; baseline as covariate; and participant as a random effect.|Baseline, Day 28|All participants who received at least 1 dose of study drug with evaluable fasting lipid (ie, cholesterol, LDL-C, HDL-C, and triglyceride) data.||milligrams per deciliter (mg/dL)||90% Confidence Interval|Least Squares Mean
659979|NCT01869959|Secondary|Change From Baseline to Week 4 in C-peptide Area Under the Curve (AUC)|Change from baseline to Week 4 in C-peptide AUC during an OGTT is presented. Blood samples were obtained prior to the glucose bolus to 2 hours after administration of the glucose bolus. The AUC measurement on Day -1 served as the baseline value. LS means were calculated using an analysis of covariance model with treatment as a fixed effect and baseline as covariate.|Predose and 2 hours postdose (Baseline, Week 4)|All participants who received at least 1 dose of study drug with evaluable C-peptide AUC data.||nanograms*hours/milliliter (ng*hr/mL)||90% Confidence Interval|Least Squares Mean
659980|NCT01869959|Secondary|Change From Baseline to Week 4 in Insulin Area Under the Curve (AUC)|Change from baseline to Week 4 in insulin AUC during an OGTT is presented. Blood samples were obtained prior to the glucose bolus to 2 hours after administration of the glucose bolus. The AUC measurement on Day -1 served as the baseline value. LS means were calculated using an analysis of covariance model with treatment as fixed effect and baseline as covariate.|Predose and 2 hours postdose (Baseline, Week 4)|All participants who received at least 1 dose of study drug with evaluable insulin (AUC) data.||micro International units*hour/mL||90% Confidence Interval|Least Squares Mean
659981|NCT01869959|Secondary|Change From Baseline to Week 4 in Glucose Area Under the Curve (AUC)|Change from baseline to Week 4 in glucose AUC during an oral glucose tolerance test (OGTT) is presented. Blood samples were obtained prior to the glucose bolus to 2 hours after administration of the glucose bolus. The AUC measurement on Day -1 served as the baseline value. LS means were calculated using an analysis of covariance model with treatment as fixed effect and baseline as covariate.|Predose and 2 hours postdose (Baseline, Week 4)|All participants who received at least 1 dose of study drug with evaluable glucose AUC data.||milligrams*hr per deciliter (mg*hr/dL)||90% Confidence Interval|Least Squares Mean
659982|NCT01869959|Secondary|7 Point Self-monitored Blood Glucose (SMBG)|The daily mean of the 7-point SMBG values is presented. Seven-point glucose profiles were measured by participants at baseline and at Week 4. The 7-point SMBG mean on Days -5, -4, or -3 served as the baseline value; the 7-point SMBG mean on Days 24, 25, or 26 served as the Week 4 value. Blood glucose was measured before and 2 hours after each meal and at bedtime.|Baseline (Day -5, -4, or -3) and Week 4 (Days 24, 25, or 26)|All participants who received at least 1 dose of study drug with evaluable 7-Point SMBG data.||mg/dL||Standard Error|Mean
659983|NCT01869959|Secondary|Change From Baseline to Day 28 in Fasting Glucose|Change from baseline to Day 28 in fasting blood glucose is presented. The predose fasting blood glucose measurement on Day 1 served as the baseline value. LS means were calculated using a linear mixed effects model with treatment, day, and treatment times day as fixed effects; baseline as covariate; and participant as a random effect.|Baseline, Day 28|Participants who received at least 1 dose of study drug with evaluable blood glucose data.||milligrams per deciliter (mg/dL)||90% Confidence Interval|Least Squares Mean
659984|NCT01869959|Primary|Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration|The number of participants with 1 or more SAEs considered by the investigator to be related to study drug administration is reported. SAEs were classified using the Medical Dictionary for Regulatory Activities (MedDRA) 11.0. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through Day 56|All participants who received at least 1 dose of study drug.||number of participants|||Number
659985|NCT01869699|Secondary|2-hour Change Over Time Heart Rate|2-hour change over time heart rate from time of study drug administration (means adjusted to baseline HR)|Baseline to 2 hours|||BPM||Standard Error|Mean
659986|NCT01869699|Secondary|2-hour Change Over Time Systolic Blood Pressure|2-hour change over time SBP from study drug administration (means adjusted to baseline SBP)|Baseline to 2 hours|||mm Hg||Standard Error|Mean
659987|NCT01869699|Secondary|2-hour Change Over Time Core Temperature|change over time core temperature after study drug administration (adjusted to baseline core temperature)|2 hours|||degrees Celsius||Standard Error|Mean
659988|NCT01869699|Secondary|Respiratory Rate|time weighted average for respiratory rate over 4 hours. Respiratory rate was measured every 5 minutes times 4, and then every 15 minutes over the following 4 hours from the time of study drug administration. The sum of the respiratory rate values was divided by time in minutes.|Baseline to 4 hours post study drug administration|Patients in the ICU with fever, weight of > 50kg and no exclusion criteria met.||breaths per minute||Standard Error|Mean
659989|NCT01869699|Secondary|Systolic Blood Pressure|time-weighted average systolic blood pressure over 4 hours. Systolic blood pressure was measured every 5 minutes times 4, and then every 15 minutes over the following 4 hours from the time of study drug administration. The sum of the systolic blood pressure values was divided by time in minutes.|Baseline to 4 hours post study drug administration|||mm Hg||Standard Error|Mean
659990|NCT01869699|Secondary|Heart Rate|time-weighted average heart rate over 4 hours. Heart rate was measured every 5 minutes times 4, and then every 15 minutes over the following 4 hours from the time of study drug administration. The sum of the heart rate values was divided by time in minutes.|Baseline to 4 hours post study drug administration|Patients in the ICU with fever, weight of > 50kg and no exclusion criteria met.||beats per minute||Standard Error|Mean
659991|NCT01869699|Primary|Core Body Temperature|time-weighted average core body temperature over 4 hours. Core temperature was measured every 5 minutes times 4, and then every 15 minutes over the following 4 hours from the time of study drug administration. The sum of the core temperature values was divided by time in minutes.|Baseline to 4 hours post study drug administration|Patients in an ICU with fever, weighed > 50kg and did not meet any exclusion criteria.||degrees Celsius||Standard Error|Mean
659992|NCT01869686|Secondary|Ratio of Denosumab Seminal Fluid Concentration Over the Denosumab Serum Concentration at the Last Study Time Point (Day 106).||Day 106|Pharmacokinetic population with available data||ratio||Standard Deviation|Mean
659995|NCT01869686|Secondary|Area Under the Concentration-time Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Denosumab in Serum|The area under the denosumab serum concentration-time curve from time zero to last quantifiable concentration (AUClast), estimated using the linear trapezoidal method.|Days 1, 10, 22, 36, 50, 78 and 106|Pharmacokinetic population||days*ng/mL||Standard Deviation|Mean
659996|NCT01869686|Secondary|Time to Maximum Observed Concentration (Tmax) of Denosumab in Serum||Days 1, 10, 22, 36, 50, 78 and 106|Pharmacokinetic population||days||Full Range|Median
659997|NCT01869686|Secondary|Maximum Observed Concentration (Cmax) of Denosumab in Serum||Days 1, 10, 22, 36, 50, 78 and 106|Pharmacokinetic population||ng/mL||Standard Deviation|Mean
659998|NCT01869686|Primary|Area Under the Concentration-time Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Denosumab in Seminal Fluid|The area under the denosumab seminal fluid concentration-time curve from time zero to last quantifiable concentration (AUClast), estimated using the linear trapezoidal method.|Days 1, 10, 22, 36, 50, 78 and 106|Pharmacokinetic population||days*ng/mL||Standard Deviation|Mean
659999|NCT01869686|Primary|Time to Maximum Observed Concentration (Tmax) of Denosumab in Seminal Fluid||Days 1, 10, 22, 36, 50, 78 and 106|Pharmacokinetic population with available data||days||Full Range|Median
660000|NCT01869686|Primary|Maximum Observed Concentration (Cmax) of Denosumab in Seminal Fluid||Days 1, 10, 22, 36, 50, 78 and 106|Pharmacokinetic population||ng/mL||Standard Deviation|Mean
660001|NCT01869647|Secondary|Prevalence of Urological Intervention|This measure presents the prevalence of participants needing urological intervention in each arm within 90 days.|90 days|||participants|||Number
660002|NCT01869647|Primary|Radiation Exposure (Dose-Length-Product) at Baseline|Radiation exposure at baseline was collected using the mean dose length product mGy*cm.|Baseline (at enrollment)|||mGy*cm||95% Confidence Interval|Mean
660003|NCT01869478|Secondary|Mean Score on Modified Rankin Scale at 90 Days|Functional outcome at 90-days will be assessed with the modified Rankin Scale (mRS). The Modified Rankin Scale was completed by the physician; it is a 7 point scale rating any limitations in the study subject's social role. The scale ranges from 0 (no symptoms/disability) to 6 (death).|90 days|Only one participant was enrolled, so data analysis was not possible.|||||
660004|NCT01869478|Primary|Recanalization Rate of Primary Intracranial Occlusion|The degree of recanalization (none, partial, complete) will be assessed in a blinded fashion on the 24-hour computed tomographic angiogram (CTA).|24 hours|Only one participant was enrolled, so data analysis was not possible.|||||
660005|NCT01869348|Other Pre-specified|Acceptability|Acceptability will be self-reported using a variety of items taken from previous studies of physical activity interventions and usability|12 weeks||||||
660006|NCT01869348|Other Pre-specified|Feasibility|We will use many different measures of feasibility, including adherence to study protocol, attrition, barriers to adherence, exposure/dose of intervention received, and any adverse events that occur|12 weeks||||||
660007|NCT01869348|Secondary|Change in Weight From Baseline to 12 Weeks|We will measure weight (and height at baseline) using a calibrated scale|12 weeks||||||
660008|NCT01869348|Secondary|Change in Physical Function From Baseline to 12 Weeks|Functional measurements will be made using the Senior Fitness Test|12 weeks||||||
660009|NCT01869348|Secondary|Change in Body Composition From Baseline to 12 Weeks|We will use dual x-ray absorptiometry (DEXA) to measure body composition, including body fat percentage and lean mass|12 weeks||||||
660010|NCT01869348|Secondary|Change in Physical Fitness From Baseline to 12 Weeks|We will use the six minute walk test to measure physical fitness|12 weeks||||||
660011|NCT01869348|Secondary|Change in Autonomous Motivation From Baseline to 12 Weeks|We will measure feelings of autonomous and controlled motivation/regulation for physical activity|12 weeks||||||
660012|NCT01869348|Secondary|Change in Sedentary Behavior From Baseline to 12 Weeks|Minutes of total sedentary time measured over a seven day period|12 weeks||||||
660013|NCT01869348|Primary|Change in Physical Activity From Baseline to 12 Weeks|Minutes of physical activity measured over a seven day period|12 weeks|||minutes||Standard Deviation|Mean
660014|NCT01869075|Primary|Percentage of Patients Prescribed Appropriate VTE Prophylaxis|"Rates of appropriate VTE prophylaxis were determined as the number of patients who received VTE prophylaxis as a proportion of the number of patient at risk.
Rates reported are for the active phases (phase 1 and phase 2) and compare intervention to control.
Appropriate VTE prophylaxis was defined as:
in Hip Fracture Surgery - evidence-based VTE prophylaxis ordered within 24 of admission, restarted within 24 hours after surgery and continued for at least 10 days post-discharge in Major General Surgery - evidence-based VTE prophylaxis ordered within 24 hours post-surgery and continued for the duration of hospital stay in Acute Medical Illness - evidence-based VTE prophylaxis ordered within 24 hours of admission and continued for the duration of hospital stay.
Evidence-based VTE prophylaxis was determined to be according to the American College of Chest Physicians (ACCP) guidelines. The 9th version was the most current version at the time of the study."|End of study (end of phase 2) - measured over duration of hospital stay.|The number of participants in the analysis was 720. In phase 1, there were 360 patients included and in phase 2, an additional 360 patients were included. The outcomes by end of study (end of phase 2) are reported. The patients in control (usual care) and intervention (Knowledge Translation toolkit) were compared.||percentage of patients|||Number
660015|NCT01868997|Secondary|Change From Baseline in GO-QOL Scale - Appearance to Week 24 (MMRM)|The GO-QOL is a 16-item self-administered questionnaire used to assess the perceived effects of TED by the participants on their daily physical and psychosocial functioning. Two subscales of the 16-question GO-QOL have been defined: Visual Functioning and Appearance, with 8 questions comprising each subscale. Transformed Appearance score is the sum of scores from the following 8 questions to a scale of 0 (worst health) to 100 (best health): feel appearance has changed, feel being stared at, feel people react unpleasantly, influence on self-confidence, feel socially isolated, influence on making friends, appear less often on photos, try to mask changes in appearance.|Baseline to Week 24|Intent to Treat Population: all participants who were randomized to treatment and received at least 1 dose of medication (either teprotumumab or placebo). A change from baseline of zero was imputed at the first postbaseline visit for participants with no postbaseline assessment.||units on a scale||Standard Error|Least Squares Mean
660016|NCT01868997|Secondary|Change From Baseline in GO-QOL Scale - Visual Functioning to Week 24 (MMRM)|The GO-QOL is a 16-item self-administered questionnaire used to assess the perceived effects of TED by the participants on their daily physical and psychosocial functioning. Two subscales of the 16-question GO-QOL have been defined: Visual Functioning and Appearance, with 8 questions comprising each subscale. Transformed Visual Functioning score is the sum of scores from following 8 questions to a scale of 0 (worst health) to 100 (best health): bicycling, driving, moving around the house, walking outdoors, reading, watching TV, hobby or pastime, feel hindered.|Baseline to Week 24|Intent to Treat Population: all participants who were randomized to treatment and received at least 1 dose of medication (either teprotumumab or placebo). A change from baseline of zero was imputed at the first postbaseline visit for participants with no postbaseline assessment.||units on a scale||Standard Error|Least Squares Mean
660017|NCT01868997|Secondary|Change From Baseline in CAS to Week 24 (MMRM)|The 7-item European Group on Graves' Ophthalmopathy (EUGOGO) amended CAS was used to evaluate clinical activity. For each of the following items, one point is given: spontaneous orbital pain, gaze evoked orbital pain, eyelid swelling that is considered to be due to active (inflammatory phase) Graves' ophthalmopathy (GO), eyelid erythema, conjunctival redness that is considered to be due to active (inflammatory phase) GO, chemosis, and inflammation of caruncle or plica. The sum of these points is the total score, with 0 indicating no clinical activity and 7 indicating the most severe clinical activity.|Baseline to Week 24|Intent to Treat Population: all participants who were randomized to treatment and received at least 1 dose of medication (either teprotumumab or placebo). A change from baseline of zero was imputed at the first postbaseline visit for participants with no postbaseline assessment.||units on a scale||Standard Error|Least Squares Mean
660018|NCT01868997|Secondary|Change From Baseline in Proptosis of the Study Eye to Week 24 (MMRM)|Proptosis is the amount of protrusion of the eye from the orbital rim. Measurements were recorded using the Hertel exophthalmometer. Participants with a decrease ≥ 2 mm were considered improving, those with an increase or decrease < 2 mm were considered remaining stable, and those with an increase ≥ 2 mm were considered worsening.|Baseline to Week 24|Intent to Treat Population: all participants who were randomized to treatment and received at least 1 dose of medication (either teprotumumab or placebo). A change from baseline of zero was imputed at the first postbaseline visit for participants with no postbaseline assessment.||mm||Standard Error|Least Squares Mean
660019|NCT01868997|Secondary|Change From Baseline in Graves’ Ophthalmopathy Quality of Life (GO-QOL) Scale - Overall to Week 24 (Mixed-Model Repeated Measures [MMRM])|The GO-QOL is a 16-item self-administered questionnaire used to assess the perceived effects of thyroid eye disorder (TED) by the participants on their daily physical and psychosocial functioning. Two subscales of the 16-question GO-QOL have been defined: Visual Functioning and Appearance, with 8 questions comprising each subscale. The transformed overall score is the sum of scores from all 16 questions to a scale of 0 (worst health) to 100 (best health).|Baseline to Week 24|Intent to Treat Population: all participants who were randomized to treatment and received at least 1 dose of medication (either teprotumumab or placebo). A change from baseline of zero was imputed at the first postbaseline visit for participants with no postbaseline assessment.||units on a scale||Standard Error|Least Squares Mean
660020|NCT01868997|Primary|Responder Status at Week 24|Number of participants classified as responders and non-responders at Week 24. Responders were defined as participants with a reduction in clinical activity score (CAS, see Outcome Measure 6 description for details) of ≥ 2 points, and a reduction in proptosis (amount of protrusion of the eye from the orbital rim) of ≥ 2 mm in the study eye, and no deterioration (increase in CAS of ≥ 2 points or increase in proptosis of ≥ 2 mm) in the non-study eye. Participants who had no assessment at 24 weeks were considered non-responders.|Week 24|Intent to Treat Population: all participants who were randomized to treatment and received at least 1 dose of medication (either teprotumumab or placebo).||Participants|||Count of Participants
660021|NCT01868893|Secondary|Number of Participants With Objective Response|Objective response is defined as either complete response [CR], complete response with incomplete recovery [CRi], or partial response [PR] as determined by the treating physician’s standard practice at the end of treatment or premature discontinuation from study per the International Workshop on Chronic Lymphocytic Leukemia Criteria (iwCLL criteria). Patients who have not achieved a CR or a PR, and who have not exhibited progressive disease, will be considered to have stable disease (which is equivalent to a nonresponse).|Up to end of treatment or premature discontinuation from study (up to 7 months from Day 1)|Efficacy evaluable population: It included participants who received at least one dose of study drug and had measurable disease at baseline and at least one post-baseline tumor assessment or who died within 28 days after the last dose of the study drug||participants|||Number
660022|NCT01868893|Secondary|Number of Participants With Adverse Events (AEs), AEs of Grade 3 and Above Severity, AEs of Special Interest (AESI), AEs Leading to Obinutuzumab Discontinuation or Dose Delays, Serious Adverse Events (SAEs), and Death|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0 was used for grading the AEs. According to NCI CTCAE, Grade 3 = severe or medically significant but not immediately life threatening; Grade 4 = life-threatening consequences, urgent intervention indicated, and Grade 5 = death. AESIs included all tumor lysis syndrome, serious infections, serious infusion-related reactions (IRR), and hepatitis B reactivation. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.|Up to 28 days after the last dose of study drug (up to 7 months from Day 1)|Safety Population: It included all enrolled participants who received at least one dose of study drug.||participants|||Number
660023|NCT01868893|Primary|Number of Participants Who Received Obinutuzumab and Chlorambucil in the Study|Number of participants who received obinutuzumab and chlorambucil in the study are presented in the below table.|Cycles 1 to 6 (28-day cycles)|Intent-to-Treat population: It included all enrolled participants in the study.||participants|||Number
660064|NCT01868009|Secondary|Number of Participants With the Indicated Device Preference Based on the Number of Steps Needed to Take the COPD Medication|The number of participants who expressed the indicated device preference (i.e., preference for ELLIPTA inhaler, preference for DISKUS inhaler, and no preference) based on the number of steps needed to take the COPD medication was summarized by study inhaler use sequence.|up to Study Day 26|PP Population||Participants|||Number
660024|NCT01868776|Primary|Effect of Buffered Lidocaine on the Success of the Inferior Alveolar Nerve Block in Patients With Symptomatic Irreversible Pulpitis.|100 patients diagnosed with symptomatic irreversible pulpitis of a mandibular posterior tooth randomly received a conventional inferior alveolar nerve block (IAN) block using either 2.8 ml of 4% lidocaine with 1:100,000 epinephrine or 2.8 ml of 4% lidocaine with 1:100,000 epinephrine buffered with sodium bicarbonate in a double-blind manner. For the buffered solution, each cartridge was buffered with 8.4% sodium bicarbonate to produce a final concentration of 0.18 mEq/mL of sodium bicarbonate. Fifteen minutes after administration of the IAN block, profound lip numbness was confirmed and endodontic access was initiated. Success was determined as no or mild pain on access or instrumentation of the root canal. Higher numbers on the VAS are indicative of more pain and less success and the VAS scale ranged from 0 to 170 mm.|approximately 15 minutes after injection|||percentage of participants|||Number
660025|NCT01868776|Primary|Pain Measurement as Assessed on a Visual Analog Scale||pain at time of treatment (after buffered versus nonbuffered numbing solution) average of 15 minutes after injection||12/2015||||
660026|NCT01868633|Other Pre-specified|Number of Participants With Chronic Pain After Cesarean Delivery|Comparison of incidence of chronic pain associated with cesarean delivery between the 2 groups|6 months|Study participants had a telephone call follow-up 6 months after cesarean delivery by a research nurse. They were asked questions about current pain symptoms and if it is related to their cesarean delivery. Seven patients in the dexamethasone group and eight patients in the placebo did not respond when contacted||Participants|||Count of Participants
660027|NCT01868633|Secondary|Incidence and Severity of Nausea and Pruritus|Patients were asked to rate the severity of postoperative nausea using an 11-point numerical rating scale (NRS) from 0 to 10, (0: no nausea, 10: worst nausea possible). The number of vomiting episodes, if any during the 24-hour study period, was documented. Pruritus was also assessed using an 11-point NRS (0 no pruritus,10 worst pruritus possible)|24 hours|||units on a scale||Inter-Quartile Range|Median
660028|NCT01868633|Secondary|Quality of Recovery|Comparison of the quality of Recovery between the 2 groups using a Quality of recovery questionnaire (QoR-40). It incorporates five dimensions of health: patient support, comfort, emotions, physical independence, and pain; each item is graded on a five-point Likert scale. QoR-40 scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery). The scores on all 40 items are summed and the mean scores and standard deviation calculated for each study group|48 hours|Two patients in the dexamethasone group and 8 patients in the placebo did not complete the quality of recovery questionnaire.||units on a scale||Standard Deviation|Mean
660029|NCT01868633|Secondary|Postoperative Pain at Rest and With Movement 24 Hours After Cesarean Delivery|Pain scores were assessed at 6, 12 and 24 hours after surgery using a numerical rating scale (10 cm line marked at 1 cm intervals anchored on the left with “no pain” = 0 and “the worst possible pain = 10). Pain was assessed at rest and with movement|24 hours|||units on a scale||Inter-Quartile Range|Median
660030|NCT01868633|Primary|Postoperative Analgesia|Comparison of postoperative opioid analgesia use between the 2 groups|24 hours|||milligrams of morphine||Inter-Quartile Range|Median
660031|NCT01868542|Secondary|Incidence of Adverse Events|A treatment emergent adverse event (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than the day of visit 22.(week 20)|Week 20|"Safety analysis set - included all subjects receiving at least one dose of the trial product. Subjects in the safety set contributed to the evaluation as treated."||events|||Number
660032|NCT01868542|Secondary|Change in Fasting Plasma Glucose From Baseline|Change in fasting plasma glucose from baseline.|Week 0, week 20|Full analysis set (FAS) - included all randomised subjects.2 subjects withdrew after randomisation in the detemir (2-4-6-8 algorithm) arm.||mg/dL||Standard Deviation|Mean
660033|NCT01868542|Secondary|Incidence of Hypoglycaemic Episodes : Nocturnal (23:00-05:59) and Over 24 Hours.|A hypoglycaemic episode was defined as treatment emergent if the onset of the episode occurred after the first administration of the investigational medicinal product (IMP), and no later than the last day on trial product. Hypoglycaemic episodes were defined as nocturnal if the time of onset was between 23:00 and 05:59 inclusive. All plasma glucose values: · equal or below 3.9 mmol/L (70 mg/dL) or · higher than 3.9 mmol/L (70 mg/dL) when they occur in conjunction with hypoglycaemic symptoms.|For 20 weeks of treatment and over 24 hours|Safety Analysis Set (SAS): Included all subjects receiving at least one dose of trial product. Subjects contributed to the evaluation “as treated”.||Episodes|||Number
660034|NCT01868542|Secondary|Change in Fasting Plasma Glucose From Baseline|Change in fasting plasma glucose from baseline.|week 0, week 12|Full analysis set (FAS) - included all randomised subjects.2 subjects withdrew after randomisation in the detemir (2-4-6-8 algorithm) arm.||mg/dL||Standard Deviation|Mean
660035|NCT01868542|Secondary|Proportion of Subjects Achieving HbA1c Below 7.0%|Responder was a dichotomous endpoint (responder/non-responder) that was defined based on whether a subject had met the ADA HbA1c target at end of trial (HbA1c < 7.0% at end of trial) during 20 weeks of treatment.|Week 20|Full analysis set (FAS) - included all randomised subjects. 2 subjects withdrew after randomisation in the detemir (2-4-6-8 algorithm ) arm.||percentage (%) of subjects|||Number
660036|NCT01868542|Secondary|Change in HbA1c|Change in HbA1c at 12 weeks of treatment from visit 2.|Week 0, week 12|Full analysis set (FAS) - included all randomised subjects. 2 subjects withdrew after randomisation in the detemir (2-4-6-8)algorithm arm.||Percent (%) glycosylated haemoglobin||Standard Deviation|Mean
660037|NCT01868542|Primary|Change in Glycosylated Haemoglobin A1c (HbA1c) From Baseline.|Change in glycosylated haemoglobin A1c (HbA1c) (%) from baseline after 20 weeks of treatment. Only the subjects in the full analysis set with HbA1c values after 20 weeks of treatment were included.|Week 0, week 20|Full analysis set (FAS) - included all randomised subjects. 2 subjects withdrew after randomisation in the detemir (2-4-6-8 algorithm) arm.||Percent (%) glycosylated haemoglobin||Standard Deviation|Mean
660038|NCT01868503|Secondary|Pathologic Complete Response Rate for Those Patients Undergoing Surgical Resection Defined as no Evidence of Residual Tumor in the Breast and Lymph Nodes|Proportion of patients who achieve a pathological complete response will be estimated with 95% exact confidence intervals.|Up to 12 weeks|Of the patients in the treatment arm, only 1 received surgery.||Participants|||Count of Participants
660039|NCT01868503|Secondary|Incidence of Adverse Events Graded According to Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0|Adverse events will be tabulated by organ system and severity.|Up to 12 weeks|Participants enrolled in the study.||incidencts|||Number
660040|NCT01868503|Secondary|Change in the Proportion of BCSCs|Defined as the difference between the percentage of BCSCs before and after treatment. Proportion of biopsy samples that are evaluable for BCSCs will be estimated along with 95% exact confidence intervals. BCSC results will be summarized using medians and interquartile ranges. Changes in BCSCs will be assessed using the Wilcoxon signed rank test.|Baseline to 12 weeks|This outcome was not analyzed due to lack of funding. It may be re-evaluated in the future. Data were not collected and the outcome measure was not analyzed.|||||
660041|NCT01868503|Secondary|Feasibility of Assessing the Effects of Lapatinib and Radiation Therapy on BCSCs Using Flow Cytometry and SCGEP|Defined as the percentage of biopsy specimens for which the SCGEP assay achieves a non-zero number.|12 weeks|Data were not collected and the outcome measure was not analyzed.|||||
660042|NCT01868503|Primary|Percentage of Patients Achieving Complete Clinical Response|Complete clinical response will be defined as the absence of tumor on the chest wall, in the treated breast, or in the nodal regions as assessed by clinical examination +/- radiographic imaging (if clinically indicated).|Up to 12 weeks|||Participants|||Count of Participants
660043|NCT01868334|Secondary|Year 2 Pre-post Study: Change From Year 1 in the Percentage of Participants Who Were Vaccinated at the End of Year 2|Outcome listed is total percentage point difference in vaccination rates from end of year 1 to end of year 2|% vaccinated by 1/31/2015|||percent change in vaccination rates|||Number
660044|NCT01868334|Primary|Year 1 RCCT: Change From Baseline in the Percentage of Participants Who Were Vaccinated at the End of Year 1|Outcome listed is total percentage point difference in vaccination rates from baseline to end of year 1|% vaccinated by 5/31/2014 (Tdap, Pneumococcal); % vaccinated by 1/31/2014 (Influenza)|||percent change in vaccination rates|||Number
660045|NCT01868243|Secondary|Spontaneous Echo Contrast|Spontaneous Echo Contrast showed in Transesophageal echocardiography|90 days|||participants|||Number
660046|NCT01868243|Primary|Intracardiac Thrombus|The primary endpoint was the detection of intracardiac thrombus in TEE at the end of follow-up (90 days).|90 days|A total of 34 patients were selected between August 2013 and November 2014 (6 were excluded for previous intracardiac thrombus; 1 for unstable INR control). Of the 27 randomized, 15 were assigned to receive dabigatran and 12 to receive warfarin.||participants||95% Confidence Interval|Number
660047|NCT01868074|Secondary|Change in CPEI (3mph)|The Center of Pressure Excursion Index (CPEI) is a measurement of the lateral displacement of the center of pressure curve from a reference line drawn from the initial to the final centers of pressure during stance phase of gait, and standardized to the width of the anterior third of the foot during pedobarography.|baseline, 8 weeks postpartum|||ratio||Standard Error|Mean
660048|NCT01868074|Secondary|Change in Arch Rigidity|The arch rigidity index, a measure of the ability of the foot to maintain the arch when weight-bearing, was determined by dividing the standing AHI by the seated AHI. A value of 1.0 would indicate a perfectly rigid arch, while smaller values would indicate a more flexible arch.|baseline, 8 weeks postpartum|||ratio||Standard Error|Mean
660049|NCT01868074|Primary|Change in Arch Drop|Measurement of Arch Drop (Sitting arch height minus standing arch height) using Arch Height Index Measurement System|baseline, 8 weeks postpartum|||mm||Standard Error|Mean
660050|NCT01868035|Secondary|Overall Survival|Overall survival (time to death) is defined from the start of treatment to the date of death from any cause.|From Baseline until Week 25 and follow-up (up to 130 months)|ITT Population||months||95% Confidence Interval|Median
660051|NCT01868035|Secondary|Number of Participants Converting to Human Anti-Murine (Mouse) Antibody (HAMA) Positivity at Any Follow-up Visit From HAMA Negativity at Baseline|The number of participants who developed human anti-murine (mouse) anibodies (HAMA) after treatment was measured.|Baseline; any follow-up visit (up to 72 months)|ITT Population||participants|||Number
660052|NCT01868035|Secondary|Number of Participants Needing Supportive Care at Week 7 and Week 13|During the administration of unlabeled Anti-B1 antibody and Iodine-131 Anti-B1 antibody, emergency support for anaphylaxis, including epinephrine, diphenhydramine, hydrocortisone, a laryngoscope, and an endotracheal tube, was readily available. The use of steroids were discouraged unless other measures were ineffective.|Week 7 and Week 13|ITT Population||participants|||Number
660053|NCT01868035|Secondary|Time to Nadir for the Indicated Hematology Toxicities|Hematology toxicities included ANC (calculated), WBC count, platelet count, and hemoglobin. Nadir is defined as the lowest counts (for ANC, WBC, and platelet counts)/concentration (for hemoglobin) that the cells reach after chemotherapy. Time to nadir is defined as the time from Baseline to the lowest value recorded up to 120 days following the therapeutic dose.|From Baseline until Week 25 and follow-up (up to 130 months)|ITT Population||days||Standard Deviation|Mean
660054|NCT01868035|Secondary|Nadir for the Indicated Hematology Toxicities|Hematology toxicities included ANC (calculated), hemoglobin, platelet count, WBC count. Nadir is defined as lowest counts that the cells reach after chemotherapy.|From Baseline until Week 25 and follow-up (up to 130 months)|ITT Population||10^3 cells/millimeters cubed (mm^3)||Standard Deviation|Mean
660055|NCT01868035|Secondary|Time to Recovery From the Indicated Hematology Toxicities|Hematology toxicities included ANC (calculated), WBC count, platelet count, and hemoglobin. Time to recovery to Baseline grade for participants with Grade 0 toxicity at Baseline was defined as the time from the date of the last administration of study drug to the first post-nadir date with Grade 0 toxicity, with no other Grade 1-4 toxicities recorded during the next week. For participants with a Grade 1-4 toxicity at Baseline, time to recovery was defined as the time from the last administration of study drug to the first post-nadir date with a Baseline grade or better, with no other higher grade toxicities recorded during the next week. For participants with a nadir grade less than or equal to the Baseline grade, the time to recovery to the Baseline grade equaled the time to nadir.|From Baseline until Week 25 and follow-up (up to 130 months)|ITT Population||days||95% Confidence Interval|Median
660065|NCT01868009|Primary|Number of Participants With the Indicated Device Preference Based on the Size of the Numbers on the Dose Counter|The number of participants who expressed the indicated device preference (i.e., preference for ELLIPTA inhaler, preference for DISKUS inhaler, and no preference) based on the size of the numbers on the dose counter was summarized by study inhaler use sequence.|up to Study Day 26|Per Protocol (PP) Population: all participants in the Intent-to-Treat (ITT) Population (comprised of all participants who had been randomized and received one dose of at least one study inhaler) who completed at least one question from the seven preference questions||participants|||Number
660056|NCT01868035|Secondary|Number of Participants With an Adverse Experience, Including Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily have to have a casual relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or significant worsening of a pre-existing sign or symptom, or disease temporally associated with the use of a medicinal product. An SAE is defined as any experience occurring at any dose that results in the following outcomes: death, a life-threatening adverse experience, in-patient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. See the SAE/AE module for a complete list of SAEs/AEs.|From Baseline until Week 25 and follow-up (up to 130 months)|ITT Population||participants|||Number
660057|NCT01868035|Secondary|Total Body Residence Time (TBRT)|TBRT is the time at which the activity of infusion is 37% of that at time zero. Whole body images from anterior and posterior gamma camera scans were collected to assess dosimetry. The assessment of organ dosimetry required gamma camera scans from at least 4 time points. Nuclear medicine reviewers conducted a visual examination of the gamma camera scans and calculated the TBRTs. Residence time is calculated from the rate of total body clearance of iodine I-131 radioactivity during the dosimetric dose. Residence time is a measure of how long the drug resides in the body.|From Baseline until Week 25 and follow-up (up to 130 months)|ITT Population||hours||Standard Deviation|Mean
660058|NCT01868035|Secondary|Time to Treatment Failure (TTF)|TTF is defined as the time from the start of treatment to the first occurrence of treatment withdrawal, decision to seek additional therapy, study removal, disease progression, or death. Duration measures were calculated using Kaplan-Meier techniques. Disease progression was based on radiographic or photographic evidence, and assessments were made by the investigator. PD is defined as a >=50% increase from nadir in SPPD of splenic and hepatic nodules or the appearance of any new lesion during or at the end of therapy that was >1.5 centimeters (cm) by radiographic evaluation or >1.0 cm by physical examination.|From Baseline until Week 25 and follow-up (up to 130 months)|ITT Population||months||95% Confidence Interval|Median
660059|NCT01868035|Secondary|Progression-free Survival (PFS)|PFS is defined as the time from the start of treatment to the first documented progression or death. Duration measures were calculated using Kaplan-Meier techniques. Disease progression was based on radiographic or photographic evidence, and assessments were made by the investigator. PD is defined as a >=50% increase from nadir in SPPD of splenic and hepatic nodules or the appearance of any new lesion during or at the end of therapy that was >1.5 centimeters (cm) by radiographic evaluation or >1.0 cm by physical examination.|From Baseline until Week 25 and follow-up (up to 130 months)|ITT Population||months||95% Confidence Interval|Median
660060|NCT01868035|Secondary|Duration of Response and Duration of Confirmed Complete Response|Duration of response for all participants with confirmed PR, confirmed CRu, or confirmed CR is defined as the time from the first documented response to the first documented progression. CR is defined as the complete disappearance of all detectable clinical/radiographic evidence of disease, the disappearance of all disease-related symptoms if present before therapy, and the normalization of biochemical abnormalities definitely assignable to NHL. PR is defined as a >=50% decrease in the sum of the perpendicular diameters (SPPD) of splenic and hepatic nodules determined at Baseline. PD is defined as a >=50% increase from nadir in SPPD of splenic and hepatic nodules or the appearance of any new lesion during or at the end of therapy that was >1.5 centimeters (cm) by radiographic evaluation or >1.0 cm by physical examination. Confirmed response requires that the same or better response be confirmed by two consecutive post-therapy response evaluations at least 4 weeks apart.|From Baseline until Week 25 and follow-up (up to 130 months)|ITT Population. Only those participants with a confirmed response were analyzed. Duration measures were calculated using Kaplan-Meier techniques.||months||95% Confidence Interval|Median
660061|NCT01868035|Secondary|Number of Participants (Par.) With Confirmed (Con.) Complete Response (CR) Confirmed, Confirmed Complete Response Unconfirmed (CRu), Confirmed Partial Response (PR), Relapse Disease (RD), and Progressive Disease (PD)|CR is defined as the complete disappearance of all detectable clinical/radiographic evidence of disease, the disappearance of all disease-related symptoms if present before therapy, and normalization of biochemical abnormalities definitely assignable to non Hodgkin's lymphoma (NHL). PR is defined as a >=50% decrease in the sum of perpendicular diameters (SPPD) of splenic and hepatic nodules determined at Baseline. SD is defined as less than a PR, but not PD, which is defined as a >=50% increase from nadir in SPPD of splenic and hepatic nodules or the appearance of any new lesion during or at the end of therapy that was >1.5 centimeters (cm) by radiographic evaluation or >1.0 cm by physical examination. RD is defined as the appearance of any new lesion or an increase of >= 50% in the size of nodules. Confirmed response requires that the same or better response be confirmed by two consecutive post-therapy response evaluations at least 4 weeks apart.|From Baseline until Week 25 and follow-up (up to 130 months)|ITT Population. A con. CR+CRu requires that the best response be con. by the same response or better >=4 weeks apart. The individual rows for con. CR, CRu, and PR represent par. with the best response con. by the same exact response. One par. in the CR+CRu category is not counted in the con. CR category because the CR was not con. by another CR.||participants|||Number
660062|NCT01868035|Primary|Number of Participants With the Indicated Grade 4 Hematology Toxicities Following Iodine-131 Anti-B1 Antibody|Hematology parameter grades were summarized according to the National Cancer Institute’s (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 2.0. Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling; Grade 5, death. Data are presented for those participants who experienced Grade 4 toxicities. Grade 4 hematological toxicities included absolute neutrophil count (ANC) (calculated) <1000 cells/millimeters cubed (mm^3), white blood cells (WBC) <2000 cells/mm^3, platelets <50000 cells/mm^3, and hemoglobin < 8.0 grams/deciliter.|From Baseline until Week 25 and follow-up (up to 130 months)|Intent-to-treat (ITT) Population: all participants who received study drug||participants|||Number
660063|NCT01868009|Secondary|Number of Participants With the Indicated Device Preference Based on the Size of the Device|The number of participants who expressed the indicated device preference (i.e., preference for ELLIPTA inhaler, preference for DISKUS inhaler, and no preference) based on the size of the device was summarized by study inhaler use sequence.|up to Study Day 26|PP Population. Only those participants responding to the question regarding the specified attribute were analyzed.||Participants|||Number
660068|NCT01867658|Secondary|Patient Reported Quality of Life as Measured by the SF-36 at Change From Baseline at One(1) Month Follow up|The scale ranges from 0 (minimum score) to 100 (maximum) score. A higher the score represents a more favorable health rating. The SF-36 was completed at baseline before surgery and one month post index procedure; the change calculation for both mental and physical components is based on the difference in scores between these two time points.|Baseline and One (1) Month Follow-up|MITT Population minus 19 subjects with missing data at either baseline or 1 month post-procedure.||units on a scale||Standard Deviation|Mean
660069|NCT01867658|Secondary|Duration of Hospitalization (Length of Stay)||Days 0-20|MITT Population minus 2 subjects who died prior to discharge||Days||Standard Deviation|Mean
660070|NCT01867658|Secondary|Duration of Chest Tube Drainage||Day 0-46|MITT Population minus 1 subject with missing data||Days||Standard Deviation|Mean
660071|NCT01867658|Secondary|Duration of Postoperative Air Leaks From the Time of Surgery Until the Air Leak Seals||Day 0-46|MITT population minus 1 subject with missing data.||Days||Standard Deviation|Mean
660072|NCT01867658|Secondary|Number of Subjects Who Are Free From Air Leaks Immediately Following Surgery||Day 0|||Participants|||Count of Participants
660073|NCT01867658|Secondary|Percentage of Air Leaks That Are Sealed or Reduced||Day 0|Subjects in the mITT population||percentage of air leaks|Number of Air Leaks|95% Confidence Interval|Number
660074|NCT01867658|Secondary|Percentage of Subjects Without Postoperative Air Leaks Following Lung Surgery up to One (1) Month Follow-up||One (1) month|MITT Population||percentage of participants||90% Confidence Interval|Number
660075|NCT01867658|Primary|Rate of Device and/or Procedure-related Adverse Events|The primary outcome of the study is the rate of device- and/or procedure-related adverse events at one month after surgery in subjects using Progel® PALS in a VATS/Robotic procedure. Endpoint analysis of the rate of device- and/or procedure-related adverse events will be based on the Clinical Events Committee (CEC) adjudication of adverse events.|One (1) month follow-up|Number of subjects reflects subjects who have completed 1-month follow-up visit or had device/procedure related AE before discontinuation.||percentage of participants||90% Confidence Interval|Number
660076|NCT01867632|Secondary|Number of Participants With Wound Infection|Number of Participants with Wound Infection post cleft palate repair|Within 1 year of surgery|||Participants|||Count of Participants
660077|NCT01867632|Primary|Fistula Formation|Number of patients who developed post palatoplasty fistula|Within 1 year of surgery|||participants|||Number
660079|NCT01867164|Secondary|Percentage of Participants With Response to Treatment Assessed by Physician|Response to treatment was evaluated by Physician using a 5-point numerical scale: 1=No response (no improvement or condition even worsened); 2=Poor (No symptoms disappeared and symptoms are moderate to severe) 3=Moderate (improvement and symptoms are of moderate intensity); 4=Good (much improvement, but there are still some occasional mild symptoms); 5=Excellent (all symptoms disappeared).|8 days after treatment (Day 12 for Gynoclin V or Day 18 for Vagitrol V)|Participants who received at least 1 dose of study medication and who were evaluated for efficacy parameters were included in ITT population. Here 'N' specifies participants who were evaluated for this outcome measure.||Percentage of Participants|||Number
660080|NCT01867164|Secondary|Percentage of Participants With Response to Treatment Assessed by Participant|Response to treatment was evaluated by participant using a 5-point numerical scale: 1=No response (no improvement or condition even worsened); 2=Poor (No symptoms disappeared and symptoms are moderate to severe) 3=Moderate (improvement and symptoms are of moderate intensity); 4=Good (much improvement, but there are still some occasional mild symptoms); 5=Excellent (all symptoms disappeared).|8 days after treatment (Day 12 for Gynoclin V or Day 18 for Vagitrol V)|Participants who received at least 1 dose of study medication and who were evaluated for efficacy parameters were included in ITT population. Here 'N' specifies participants who were evaluated for this outcome measure.||Percentage of Participants|||Number
660081|NCT01867164|Primary|Percentage of Participants With the Presence of Microorganisms (Single-celled, Tiny Organisms That Include Fungi, Bacteria, Viruses) 3 Days After Treatment|Percentage of participants with the presence of microorganisms (Candida albicans, Candida species, Gardnerella vaginalis, Vaginal flora, Lactobacillus species) in the wet mount, KOH, gram stain and vaginal discharge culture (candida and symptomatology) 3 days after treatment.|3 days after treatment (Day 7 for Gynoclin V or Day 13 for Vagitrol V)|Participants who received at least 1 dose of study medication and who were evaluated for efficacy parameters were included in ITT population. Here 'N' signifies participants who were evaluated for this outcome measure including the participants for whom no culture was performed.||Percentage of Participants|||Number
660082|NCT01867164|Primary|Percentage of Participants With Presence or Absence of Symptoms 8 Days After Treatment|Participants were evaluated for presence or absence of symptoms (itching, burning and sudden vulvar pain) in response to treatment.|8 days after treatment (Day 12 for Gynoclin V or Day 18 for Vagitrol V)|Participants who received at least 1 dose of study medication and who were evaluated for efficacy parameters were included in ITT population. Here 'N' specifies participants who were evaluated for this outcome measure.||Percentage of Participants|||Number
660083|NCT01867164|Primary|Percentage of Participants With Presence or Absence of Symptoms 3 Days After Treatment|Participants were evaluated for presence or absence of symptoms (itching, burning and sudden vulvar pain) in response to treatment.|3 days after treatment (Day 7 for Gynoclin V or Day 13 for Vagitrol V)|Participants who received at least 1 dose of study medication and who were evaluated for efficacy parameters were included in Intent-to-treat (ITT) population. Here 'N' specifies participants who were evaluated for this outcome measure.||Percentage of Participants|||Number
660091|NCT01867021|Secondary|Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV and TIVf|Safety was assessed as the number of subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after vaccination of TIV and control.|Day 1 to 7 postvaccination|Analysis was done on the safety dataset, i.e. the subjects in the exposed population who provided postvaccination safety data.||Subjects|||Number
660092|NCT01867021|Secondary|Geometric Mean Ratio of Subjects Against Each of Three Strains After One Vaccination of TIV and TIVf Vaccine|Geometric mean ratio (GMR) of subjects was calculated as the ratio of postvaccination to prevaccination HI GMTs against each of three vaccine strains, three weeks after vaccination of TIV and TIVf vaccine (day 22).|Day 22|Analysis was done on the PPS1||Ratios||95% Confidence Interval|Geometric Mean
660093|NCT01867021|Secondary|Evaluation of Percentages of Subjects Who Achieved HI Seroconversion and HI Titer ≥1:40 Against Each of Three Strains After One Vaccination of TIV and TIVf Vaccine|"Percentage of subjects achieving HI seroconversion against each of three vaccine strains was measured three weeks after vaccination of TIV and TIVf vaccine (day 22).
Percentage of subjects who achieved HI titer ≥1:40 against each of three vaccine strains was measured three weeks after one vaccination of TIV and TIVf vaccine.
According to Center for Biologics Evaluation and Research recommendations (CBER 2007), the criterion for seroconversion is considered met if the lower limit of the two-sided 95% CI for the percentage of subjects with HI seroconversion is ≥40% (<65 years) or ≥30% (≥65 years).
As per the CBER criteria, the lower limit of the two-sided 95% CI for the percentage of subjects who achieved HI titer ≥ 1:40 should be ≥70% (<65 years) or ≥60% (≥65 years)."|Day 22|Analysis was done on the PPS1 for HI Titer ≥1:40 at day 22 and PPS2 for Seroconversion||Percentages of subjects||95% Confidence Interval|Number
660094|NCT01867021|Primary|Percentages of Subjects Achieving Seroconversion (SC) in Antibody Titers in the TIV Group Compared With the Corresponding Percentages of Subjects in the TIVf Group for All Three Strains At Day 22, in Healthy Adults Aged ≥50 Years|"Non-Inferiority was measured as the percentages of subjects who achieved seroconversion in HI titers three weeks (day 22) after vaccination of TIV compared with TIVf, against each of three vaccine strains.
Seroconversion is defined as a prevaccination titer <10 and postvaccination HI ≥40 or as a prevaccination titer ≥10 and at minimum four-fold rise in postvaccination antibody titer.
The upper limit of the two-sided 95% CI on the difference between the seroconversion rates (Seroconversion TIVf - SeroconversionTIV) should not exceed 10%."|Day 22|Analysis was done on the PPS2, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at visit 1 and visit 2; and had no major protocol violations as defined prior to analysis||percentages of subjects||95% Confidence Interval|Number
660095|NCT01867021|Primary|Hemagglutination Inhibition (HI) Geometric Mean Titers (GMTs) of TIV Group and TIVf Group for All Three Strains, in Healthy Adults Aged ≥50 Years|"Non-inferiority of Postvaccination Hemagglutination Inhibition (HI) Geometric Mean Titers (GMTs) of TIV (Trivalent Subunit Inactivated Influenza Vaccine) Group Over the Corresponding TIVf Group for All Three Strains, three weeks after vaccination (day 22).
The upper limit of the two-sided 95% confidence interval (CI) on the ratio of GMTs (GMT TIVf/GMT TIV) should not exceed the non-inferiority margin of 1.5."|Day 22|Analysis was done on the per-protocol set 1 (PPS1) , ie, the subjects who received the vaccine correctly; provided evaluable serum samples at visit 2; and had no major protocol violations as defined prior to analysis.||Titers||95% Confidence Interval|Geometric Mean
660096|NCT01866709|Secondary|Change in Serum Sodium, Magnesium, Calcium Levels From Baseline After Administration of SPS.||First 48 hours|Study was prematurely terminated for safety reasons; no statistical analyses were conducted.|||||
660097|NCT01866709|Primary|Change in Serum Potassium Levels From Baseline After Administration of Sodium Polystyrene Sulfonate (SPS) Three Times a Day Without Co-administration of Sorbitol; Determine Incidence of Adverse Events.|To perform a controlled evaluation of the safety and efficacy of 15g of SPS administered 3 times daily for 48 hours (6 doses) in patients with hyperkalemia (serum potassium levels between 5.0 - 6.5 mmol/l) at baseline.|First 48 hours|Study prematurely terminated for safety reasons; no statistical analyses were conducted.|||||
660098|NCT01866423|Secondary|Number of Participants With Grade 3 or Higher Toxicity|Summary of grade 3 (per Common Terminology Criteria for Adverse Events (CTCAE v4.0) or higher toxicities which generally is described as a severe reaction or symptom.|30 days|Tracked during treatment period until 30 days after last dose of study drug.||Participants|||Count of Participants
660099|NCT01866423|Secondary|Duration of Response Using RECIST Version 1.1 and PCWG2 Criteria|Response will be tabulated descriptively with 95% CIs and Kaplan-Meier survival curves, as appropriate.|Up to 3 years|Only 4 patients was accrued to this trial. No data analysis was performed.|||||
660100|NCT01866423|Secondary|Overall Response Rate Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 and PCWG2 Criteria|Response will be tabulated descriptively with 95% confidence intervals (CIs) and Kaplan-Meier survival curves, as appropriate.|Up to 3 years|Only 4 patients was accrued to this trial. No data analysis was performed.|||||
660101|NCT01866423|Secondary|Absolute Change in PSA|Values will be tabulated as outlined in the PCWG2 criteria and presented as Kaplan-Meier survival curves, as appropriate.|Baseline to 24 weeks|Only 4 patients was accrued to this trial. No data analysis was performed.|||||
660102|NCT01866423|Secondary|Best PSA Response|Values will be tabulated as outlined in the PCWG2 criteria and presented as Kaplan-Meier survival curves, as appropriate.|Up to 24 weeks|Only 4 patients was accrued to this trial. No data analysis was performed.|||||
660103|NCT01866423|Primary|PSA Response, Defined as Occurrence of PSA Decline to Greater Than or Equal to 50% From Baseline|Standard descriptive methods will be used to summarize PSA. Values will be tabulated as outlined in the Prostate Cancer Working Group 2 (PCWG2) criteria and presented as Kaplan-Meier survival curves, as appropriate.|At 12 weeks|Only 4 patients were accrued to this trial. No data analysis was performed.|||||
660104|NCT01866423|Primary|Androgen Receptor (AR) Protein Expression Levels in CTCs|The two-sample t-test will be used. Once association between AR protein expression levels and response is established, graphical methods such as receiver-operator curves (ROC) or more quantitative methods such as the maximal chi-square method to determine whether there might be a cut-point with either great sensitivity or great specificity (or both) for identifying a cohort with either a high or low likelihood of prostate-specific antigen (PSA) response.|Up to 4 weeks|Only 4 patients were accrued to this trial. No data analysis was performed.|||||
660105|NCT01866319|Secondary|Overall Response Rate (ORR)|"ORR was defined as the percentage of the participants with a best tumor response of complete response (CR) or partial response (PR) based on blinded independent central radiologic and clinical review using RECIST 1.1. CR was defined as disappearance of all target lesions with any pathological lymph nodes having a reduction in short axis to <10 mm. PR was defined as a 30% or greater decrease in the sum of diameters of target lesions.
Statistical testing was stratified by line of therapy (1st vs. 2nd), PD-L1) status (positive vs. negative) and ECOG performance status (0 vs. 1)"|Up to 2 years|The ITT population, comprising all participants randomized to a study arm; data collected through 3 September 2014.||Percentage of Participants||95% Confidence Interval|Number
660106|NCT01866319|Primary|Overall Survival (OS)|OS was defined as the time from randomization to death due to any cause. The reported percentage is estimated using a product-limit (Kaplan-Meier) method for censored data; for participants whose survival data was obtained after the data cut-off date for the interim analysis, data were censored at the date of cut-off (3 March 2015). Statistical testing was stratified by line of therapy (1st vs. 2nd), PD-L1) status (positive vs. negative) and ECOG performance status (0 vs. 1).|Month 12|The ITT population, comprising all participants as randomized to a study arm; data collected up to 3 March 2015.||Percentage of participants||95% Confidence Interval|Number
660107|NCT01866319|Primary|Progression-free Survival (PFS)|"PFS was defined as the time from randomization to the first documented disease progression, based on blinded independent central radiologic and clinical review using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), or death due to any cause, whichever occurred first. Disease progression was defined as a 20% or greater increase in the sum of diameters of target lesions with an absolute increase of at least 5mm or the appearance of new lesions.
Statistical testing was stratified by line of therapy (1st vs. 2nd), programmed cell death ligand 1 (PD-L1) status (positive vs. negative) and Eastern Cooperative Oncology Group (ECOG) performance status (0 vs. 1)"|Up to 2 years|The ITT population, comprising all participants as randomized to a study arm; data collected up to 3 September 2014.||Months||95% Confidence Interval|Median
660108|NCT01866306|Secondary|Mean Change From Baseline in TWA Asthma Control Diary (ACD) Score of Asthmatic Participants on Days 3 to 10 (Part 2)|The ACD contains seven symptom questions (nocturnal awakening, waking in the morning with symptoms, activity limitation, shortness of breath and wheezing) which are answered on rising in the morning and retiring at bedtime. Missing scores are imputed by linear interpolation or extrapolation. Daily ACD score was fit by a Bayesian hierarchical longitudinal model with participant-specific intercept and a fixed categorical effect for day. All baseline (day -7 to day -1) ACD scores are assumed to be with equal mean. The ACD score is the sum of responses to the seven questions, with answers on a 7-point scale (0= no impairment; 6 = maximum impairment) with the score ranging from 0 to 42, and higher scores indicating greater impairment. The 95% Confidence Interval actually refers to a 95% Credible Interval. The mean percent increase is anticipated to be different from zero.|Baseline and Days 3 to 10|Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model. Participants from Part 1 were not analyzed; one participant who received a viral dose of 67 TCID 50, was included in the analysis.||Score on a scale||95% Confidence Interval|Mean
660109|NCT01866306|Secondary|Mean Percent Change From Baseline in Maximum Drop FEV1 of Asthmatic Participants (Part 2)|Log-transformed FEV1 data were fit by Bayesian hierarchical longitudinal models, with a random participant effect and a fixed categorical effect for day. All baseline (day -7 to day -1) FEV1 were assumed to be with equal mean. The FEV1 readings on the evenings of sputum inductions were excluded from the analyses. The percent decrease of the lowest FEV1 measurement after viral challenge compared to the TWA of the baseline FEV1 is presented. The 95% Confidence Interval actually refers to a 95% Credible Interval. The mean percent decrease is anticipated to be different from zero.|Baseline and up to day 7|Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model. Participants from Part 1 were not analyzed; one participant who received a viral dose of 67 TCID 50, was included in the analysis.||Percent change||95% Confidence Interval|Mean
660110|NCT01866306|Primary|Number of Asthmatic Participants Demonstrating at Least 10^3 Copies/ml of Viral RNA in Nasal Lavage Fluid on Days 1 to 14 (Part 1)|Viral RNA was measured by real time reverse transcriptase polymerase chain reaction (qRT-PCR) from nasal lavage fluid collected on day 3 and day 7 from asthmatic participants, and the number of participants with at least 10^3 copies/ml was determined.|Days 1 - 14|Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model. Healthy participants, and participants from Part 2 were not analyzed.||Participants|||Number
660111|NCT01866306|Primary|Change From Baseline in Mean Maximum Jackson Cold Symptom Score (CSS) on Days 1 to 14 in Asthmatic Participants (Part 1)|Asthmatic participants from Part 1 were treated with RV16UB virus, and challenge induced upper airway symptoms were monitored with a diary recording CSS. The CSS measures 8 cold symptoms, with each symptom scored from 0 (absent) to 3 (severe). The total score ranges from 0-24, with higher scores reflecting greater severity, and a positive change from baseline indicating worsening symptoms.|Baseline and Days 1 - 14|Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model. Healthy participants, and participants from Part 2 were not analyzed.||Score on a scale||Standard Deviation|Mean
660112|NCT01866306|Primary|TWA Percent CFB in Evening FEV1 in Asthmatic Participants on Days 1-7 (Part 2)|Log-transformed FEV1 data were fit by Bayesian hierarchical longitudinal models, with a random participant effect and a fixed categorical effect for day. All baseline (day -7 to day -1) FEV1 were assumed to be with equal mean. FEV1 assessments obtained between 3 pm to next day 3 am were counted as evening measurements. The TWA CFB evening FEV1 on days 1-7 was calculated as the difference of the mean of estimated day 1-7 evening FEV1 value and the corresponding estimated baseline value. The FEV1 readings on the evenings of sputum inductions were excluded from the analyses. The 95% Confidence Interval actually refers to a 95% Credible Interval. The anticipated mean reduction from baseline is 10%.|Baseline and Days 1- 7|Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model. Participants from Part 1 were not analyzed; one participant who received a viral dose of 67 TCID 50, was included in the analysis.||Percent change||95% Confidence Interval|Mean
660113|NCT01866306|Primary|Time -Weighted Average (TWA) Percent Change From Baseline (CFB) in Morning FEV1 in Asthmatic Participants on Days 1-7 (Part 2)|Log-transformed FEV1 data were fit by Bayesian hierarchical longitudinal models, with a random participant effect and a fixed categorical effect for day. All baseline (day -7 to day -1) FEV1 were assumed to be with equal mean. FEV1 assessments obtained between 3 am to 3 pm were counted as morning measurements. The TWA CFB morning FEV1 on days 1-7 was calculated as the difference of the mean of estimated day 1-7 morning FEV1 value and the corresponding estimated baseline value. The 95% Confidence Interval actually refers to a 95% Credible Interval. The anticipated mean reduction from baseline is 10%.|Baseline and Days 1 - 7|Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model. Participants from Part 1 were not analyzed; one participant who received a viral dose of 67 TCID50, was included in the analysis.||Percent change||95% Confidence Interval|Mean
660114|NCT01866306|Primary|Number of Asthmatic Participants Treated With a Viral Dose of 100 TCID50 With Challenge Induced Upper Airway Symptoms (Part 1)|Asthmatic participants from Part 1 were treated with RV16UB virus at a dose of 100 TCID50, and challenge induced upper airway symptoms were monitored with a diary recording Jackson Cold Symptom Score (CSS). The CSS measures 8 cold symptoms, with each symptom scored from 0 (absent) to 3 (severe). The total score ranges from 0-24, with higher scores reflecting greater severity. The number of participants with a CSS score equal or greater than 3 for two days in a row are presented.|Day 1 up to Day 7|Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model. Healthy participants, asthmatics treated with a viral dose of 10 TCID 50, and participants from Part 2 were not analyzed.||Participants|||Number
660115|NCT01866306|Primary|Number of Participants With Serious Adverse Events (SAE) (Parts 1 and 2)|A SAE is any adverse event occurring at any dose or during any use of the Sponsor's product that: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing in-patient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event.|Up to Day 24|Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.||Participants|||Number
660116|NCT01866306|Primary|Number of Healthy and Asthmatic Participants With Events of Clinical Interest (ECI) (Part 1)|ECI are selected non-serious and serious adverse events which include the following: an overdose of Sponsor's product; requirement for systemic steroids to treat asthma exacerbation related to virus challenge; acute reaction to virus challenge, confirmed through repeat measurement and when considered potentially associated with administration of virus; specified vital sign findings within 4hr of challenge; specified symptom findings within 24hr of challenge; >20% decrease in Forced Expiratory Volume in 1 second (FEV1) relative to baseline within 4hr of challenge; dyspnea associated with drop in FEV1 (within 4hr of challenge) that is unresponsive to a bronchodilator rescue agent within 20 minutes; Grade 2+ deviation from normal values of liver-related laboratory parameters at any time between challenge and day 14.|Up to Day 24|Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model. Participants from Part 2 were not analyzed.||Participants|||Number
660117|NCT01866293|Secondary|Duration of Response (DOR)||1 year|9 participants are evaluable. 2 participants never started treatment.||days||Full Range|Median
660118|NCT01866293|Secondary|Time to Progression (TTP)||1 year|9 participants are evaluable. 2 participants never started treatment.||days||Full Range|Median
660119|NCT01866293|Secondary|Safety and Toxicity in This Patient Population|Safety assessments and toxicity grading will follow CTCAE Version 4 Grade|1 year|||Participants|||Count of Participants
660120|NCT01866293|Secondary|Overall Response Rate|IMWG Criteria for Response, Progression and Relapse in Multiple Myeloma Patients|1 year|9 participants are evaluable. 2 participants never started treatment.||Participants|||Count of Participants
660122|NCT01866163|Secondary|m-PASI at Week 1|"The investigator assessed the extent and severity of the three clinical signs (redness, thickness, and scaliness) on the arms, trunk and legs. These assessments were converted to an Modified Psoriasis Area and Severity Index (m-PASI).
m-PASI (excluding head) assessed at week 4 (adjusted for the effect of (pooled) centre and baseline m-PASI.
The m-PASI score range from 0 (best) to 64.8 (worst)."|1 week|All randomised subjects were included in the full analysis set and analysed for efficacy.||Scores on a scale||95% Confidence Interval|Mean
660123|NCT01866163|Secondary|m-PASI at Week 4|"The investigator assessed the extent and severity of the three clinical signs (redness, thickness, and scaliness) on the arms, trunk and legs. These assessments were converted to an Modified Psoriasis Area and Severity Index (m-PASI).
m-PASI (excluding head) assessed at week 4 (adjusted for the effect of (pooled) centre and baseline m-PASI.
The m-PASI score range from 0 (best) to 64.8 (worst)."|4 weeks|All randomised subjects were included in the full analysis set and analysed for efficacy.||Scores on a scale||95% Confidence Interval|Mean
660124|NCT01866163|Primary|Treatment Success According to IGA|"Subjects with ‘treatment success’ (‘clear’ or ‘almost clear’ for subjects with at least moderate disease at baseline, ‘clear’ for subjects with mild disease at baseline) according to the Investigators’ global assessment of disease severity (IGA) at Week 4.
The 5 point IGA scale: 1 = clear, 2 = almost clear, 3 = mild, 4 = moderate and 5 = severe"|4 weeks|All randomised subjects were included in the full analysis set and analysed for efficacy.||percentage of subjects|||Number
660125|NCT01866150|Secondary|Change From Baseline in Total Number of Swollen Joints at Months 3 and 6 and at the Last Visit After Initiation of First-Line Biologic Treatment|The 28 joints to be assessed for swelling were shoulder, elbow, wrist, MCP joints 1-5, PIP joints 1-5, and knee on both sides of the body. The sum of swollen joints, each, ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status.|Baseline, Month 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)|Ten participants from all participants entered analysis set who could not be categorized as under biologic monotherapy or biologic combination therapy were excluded from analysis. Number of participants analyzed=participants with post-baseline available data. Here, 'n' signifies number of participants with available data at specified category.||swollen joints||Standard Deviation|Mean
660126|NCT01866150|Secondary|Change From Baseline in Total Number of Tender Joints at Months 3 and 6 and at the Last Visit After Initiation of First-Line Biologic Treatment.|The 28 joints to be assessed for tenderness were shoulder, elbow, wrist, metacarpophalangeal (MCP) joints 1-5, proximal interphalangeal (PIP) joints 1-5, and knee on both sides of the body. The sum of tender joints ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status.|Baseline, Month 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)|Ten participants from all participants entered analysis set who could not be categorized as under biologic monotherapy or biologic combination therapy were excluded from analysis. Number of participants analyzed=participants with post-baseline available data. Here, 'n' signifies number of participants with available data at specified category.||tender joints||Standard Deviation|Mean
660127|NCT01866150|Secondary|Average Methotrexate Dose of Participants on Biological Combination Treatment||Baseline up to last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)|Participants in biologic combination group from All Participants Entered Analysis Set. Number of participants analyzed=participants with available data for methotrexate dose.||milligrams per week||Standard Deviation|Mean
660128|NCT01866150|Secondary|Duration of Treatment|Drug retention was defined as the total duration of time in months the participant was on treatment (combination therapy or monotherapy). The duration was the time in months between the start date of biologic therapy to the date of most recent visit.|Baseline up to last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)|Ten participants from all participants entered analysis set who could not be categorized as under biologic monotherapy or biologic combination therapy were excluded from analysis. Number of participants analyzed=participants with post-baseline available data for duration of treatment.||months||Standard Deviation|Mean
660129|NCT01866150|Secondary|Percentage of Participants by Category of DAS28 Score and Timepoint|The DAS28 score is a measure of the participant's disease activity calculated using the TJC [28 joints], SJC [28 joints], participant's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and either ESR or CRP for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score <2.6.|Baseline, Month 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)|Ten participants from all participants entered analysis set who could not be categorized as under biologic monotherapy or biologic combination therapy were excluded from analysis. Number of participants analyzed=participants with available data for the endpoint. Here, 'n' signifies number of participants with available data for specifies category.||percentage of participants|||Number
660130|NCT01866150|Secondary|Change From Baseline in DAS28 at Months 3, 6 and at The Last Visit After Initiation of First-Line Biologic Treatment|The DAS28 score is a measure of the participant's disease activity calculated using the TJC [28 joints], SJC [28 joints], participant's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and either ESR or C Reactive Protein (CRP) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score <2.6.|Baseline, Month 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)|Ten participants from all participants entered analysis set who could not be categorized as under biologic monotherapy or biologic combination therapy were excluded from analysis. Number of participants analyzed=participants with post-baseline available data. Here, 'n' signifies number of participants with available data at specified category.||units on a scale||Standard Error|Mean
660180|NCT01863667|Primary|Percentage of Participants Who Experienced at Least One Adverse Event|An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of pre-existing conditions.|Up to 57 weeks (including 3 weeks following the last dose of study drug)|All participants as treated defined as all randomized participants who received at least one dose of study drug and were included in the treatment group corresponding to the study drug they actually received.||Percentage of participants|||Number
660131|NCT01866150|Secondary|Percentage of Participants Who Achieved Low Disease Activity (LDA) (DAS28-ESR <3.2) at Months 3 and 6 and at the Last Visit After Initiation of First-Line Biologic Treatment.|The DAS28 score is a measure of the participant's disease activity calculated using the TJC [28 joints], SJC [28 joints], participant's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the ESR for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score <2.6. LDA was defined as a DAS28 score <3.2.|Months 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)|Ten participants from all participants entered analysis set who could not be categorized as under biologic monotherapy or biologic combination therapy were excluded from analysis. Number of participants analyzed=participants with available data for DAS28-ESR. Here, 'n' signifies number of participants with available data for specified category.||percentage of participants|||Number
660132|NCT01866150|Secondary|Percentage of Participants Who Achieved DAS28-ESR Remission (DAS28-ESR <2.6) at 3 Months and at the Last Visit After Initiation of First-Line Biologic Treatment|The DAS28 score is a measure of the participant's disease activity calculated using the TJC [28 joints], SJC [28 joints], participant's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the ESR for a total possible score of 0 to approximately 10. DAS28 = (0.56 * √ of TJC) + (0.28 * √ of SJC) + (0.70 * ln ESR in mm/h) + (0.014 * participant's global assessment of disease activity). DAS28 Remission is defined as a DAS28 score < 2.6.|Month 3 and the last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)|Ten participants from all participants entered analysis set who could not be categorized as under biologic monotherapy or biologic combination therapy were excluded from analysis. Number of participants analyzed=participants with available data for DAS28-ESR. Here, 'n' signifies number of participants with available data for specified category.||percentage of participants|||Number
660133|NCT01866150|Primary|Percentage of Participants Who Achieved Disease Activity Score Based on 28-joint Count (DAS-28) and Erythrocyte Sedimentation Rate (DAS28-ESR) Remission at 6 Months (DAS28<2.6)|The DAS28 score is a measure of the participant's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], participant's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. DAS28 equals (=) (0.56 multiplied by [*] the square root [√] of TJC) plus (+) (0.28 * √ of SJC) + (0.70 * the natural logarithm [ln] ESR in millimeters per hour [mm/h]) + (0.014 * participant's global assessment of disease activity). DAS28 Remission is defined as a DAS28 score <2.6.|Month 6|Ten participants from all participants entered analysis set who could not be categorized as under biologic monotherapy or biologic combination therapy were excluded from analysis. Number of participants analyzed=participants with available data for DAS28-ESR at Month 6.||percentage of participants|||Number
660134|NCT01865812|Primary|Absolute Change From Baseline in High-density Lipoprotein (HDL) Particle Concentration||Baseline, Week 8|||umol/L||95% Confidence Interval|Least Squares Mean
660135|NCT01865812|Primary|Absolute Change From Baseline in High-density Lipoprotein (HDL) Particle Size||Baseline, Week 8|||nm||95% Confidence Interval|Least Squares Mean
660136|NCT01865812|Primary|Absolute Change From Baseline in High-density Lipoprotein (HDL) Cholesterol Concentration||Baseline, Week 8|||mmol/L||95% Confidence Interval|Least Squares Mean
660137|NCT01865747|Secondary|Objective Response Rate (ORR)|Objective Response Rate (ORR) is the number of participants with a best response of complete response (CR) or partial response (PR) divided by number of randomized participants. ORR was assessed by the Independent Radiology Committee (IRC) per RECIST 1.1 which was confirmed by a subsequent visit >= 28 days later, and was analyzed in the Intent to Treat (ITT) population at the time of the primary analysis of Progression Free Survival (PFS). The data cutoff date was 22 May 2015.|ORR was assessed at 8 weeks post-randomization, every 8 weeks for 12 months, and every 12 weeks until date of disease progression or death, up to May 2015 (approximately 21 months)|The analysis of ORR was performed in the ITT population (all randomized: 330 cabozantinib, 328 everolimus) based upon response determined by Independent Radiology Committee (IRC) per RECIST 1.1.||percentage of participants|||Number
660138|NCT01865747|Secondary|Overall Survival (OS)|Overall Survival (OS) is defined as the time from randomization to the date of death. Participants that had not died were censored at last known date alive. Median OS was calculated using Kaplan-Meier estimates. Interim analyses for OS occurred after 320 deaths (78% of the total OS events needed for final analysis).|OS was measured from the time of randomization until 320 deaths, approximately 28 months|The Intent to Treat (ITT) population was used and included 658 randomized subjects (330 cabozantinib, 328 everolimus) in the second interim analysis with a cutoff date of 31 December 2015.||months||95% Confidence Interval|Number
660139|NCT01865747|Primary|Progression-free Survival (PFS)|The primary analysis of PFS is the time from randomization to date of first documented tumor progression as determined by investigator (per RECIST 1.1 criteria) or death due to any cause, whichever occurred first. A Kaplan-Meier analysis was performed to estimate the median duration.|PFS is measured from the date of randomization until the date of first documented disease progression or date of death from any cause as determined by the Independent Radiology Committee (IRC) per RECIST 1.1, assessed for up to 17 months.|The pre-specified primary analysis of PFS was based on the first 375 randomized subjects (187 cabozantinib and 188 everolimus).||months||95% Confidence Interval|Number
660140|NCT01865084|Secondary|Pharmacokinetics (PK): Apparent Clearance (CL/F) of Tadalafil|The data reported are population estimate and inter-patient variability.|Weeks 4, 12, 24 and 36: -1 Hour up to 24 Hours Postdose|All randomized participants who received at least one dose of study drug and had evaluable PK data.||Liter per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
660181|NCT01863667|Primary|Change From Baseline in Hemoglobin A1C (A1C) at Week 54|A1C is measured as a percent. Thus, this change from baseline reflects the Week 54 A1C percent minus the Week 0 A1C percent.|Baseline and Week 54|Full Analysis Set defined as all participants who received at least one dose of study drug and had a baseline measurement or a post-randomization measurement. Due to the early termination of the study, no participants completed Week 54.|||||
660141|NCT01865084|Secondary|Change From Baseline in Pediatric Outcomes Data Collection Instrument (PODCI) Scores|"PODCI includes a Global Functioning Scale and 5 core scales:Upper Extremity and Physical Function,Transfer/Basic Mobility, Sports/Physical Functioning, Pain/Comfort,and Happiness.The Global Functioning Scale is the mean of the mean scores from 4 of the 5 core scales (all except the happiness core scale).The following PODCI scores were prespecified in the protocol for analysis: Global Functioning, Upper Extremity and Physical Function,Transfer/Basic Mobility, and Sports/Physical Functioning. The Global Functioning Scale and each of the core scales were standardized so that a score of 0 represents a poor outcome/worse health, while 100 is the best possible outcome/best health (i.e., complete range of each score is 0 to 100, with higher scores representing better functioning). The LS mean (LSM) change from baseline,standard error was derived using MMRM with factors for pooled country, treatment, visit, treatment-by-visit interaction and baseline PODC scale as covariate."|Baseline, Week 48|All randomized participants who received at least one dose of study drug who had a baseline and at least one post-baseline measurement. The reason the number of participants analyzed is significantly less than the total number of randomized participants is because PODCI was administered only in English.||Units on a scale||Standard Error|Least Squares Mean
660142|NCT01865084|Secondary|Time to Persistent 10% Worsening in Timed Function Tests (TFT)|"Time on study until the TFT becomes 10% worse than the baseline TFT and continues at that level or lower until the end of study. The time to persistent 10% worsening is the observed time after baseline until the first observed timepoint where their time used for the TFTs is >110% of the baseline time and all the time values observed afterward are also >110% of baseline. If the participant discontinues prior to experiencing persistent worsening, this outcome for the participant is censored at the date of discontinuation of the double-blind period.
Only participants with complete evaluable data were analyzed. Complete evaluable data was defined as having baseline measurement, complete dates at evaluable visits and a post-baseline measurement at each evaluable visit."|Baseline through Week 48|All randomized participants who received at least 1 dose of study drug who had complete evaluable data.Censored participants:Rise from Floor;placebo(pl)=40,0.3 mg/kg=39,0.6 mg/kg=43;Stair Climb;pl=55,0.3 mg/kg=45,0.6 mg/kg=52;10 Meter Walk/Run pl=61,0.3 mg/kg=65,0.6 mg/kg=58,Stair Descend;pl=63,0.3 mg/kg=60,0.6 mg/kg=59.||Days||95% Confidence Interval|Median
660143|NCT01865084|Secondary|Time to Persistent 10% Worsening in 6MWD|Time on study until the 6MWD becomes 10% less than the baseline 6MWD and continues at that level or lower until the end of study.|Baseline through Week 48|All randomized participants who received at least one dose of study drug who had complete evaluable data. Complete evaluable data was defined as having baseline measurement, complete dates at evaluable visits and a post-baseline measurement at each evaluable visit. Censored participants: placebo=71, 0.3 mg/kg=63, 0.6 mg/kg=61.||Days||95% Confidence Interval|Median
660144|NCT01865084|Secondary|Change From Baseline in Timed Function Tests in Seconds|Timed function tests included time it took to rise from floor, walk 10 meters, ascend 4 stairs, and descend 4 stairs.The lower the time in seconds taken, the better the performance. The LS mean change from baseline, standard error, was derived using mixed model repeated measures methodology (MMRM) with factors for pooled country, treatment, visit, treatment-by-visit interaction and Day 1 value as baseline covariate.|Baseline, Week 48|All randomized participants who received at least one dose of study drug who had a baseline and at least one post-baseline measurement.||Seconds||Standard Error|Least Squares Mean
660145|NCT01865084|Secondary|Change From Baseline in the North Star Ambulatory Assessment (NSAA) Global Score|The NSAA is a functional scale specifically designed for ambulant boys with DMD that can provide additional information on motor functions important in maintaining normal ambulation and other activities important to everyday life. The NSAA is a 17-item evaluation of standing, ability to transition from lying to sitting, sitting to standing, and other mobility assessments. Each of the 17 items is evaluated on an ordinal scale of 0, 1, or 2, with higher scores reflecting better performance on the assessment, for a total maximum score of 34. This score was transformed to a 0 to 100 scale for the key analysis (referred to as linearized), with higher transformed scores reflecting better performance.The LS mean (LSM) change from baseline standard error was derived using mixed model repeated measures methodology (MMRM) with factors for pooled country, treatment, visit, treatment-by-visit interaction and Day 1 value as baseline covariate.|Baseline, Week 48|All randomized participants who received at least one dose of study drug who had a baseline and at least one post-baseline measurement.||Units on a scale||Standard Error|Least Squares Mean
660146|NCT01865084|Primary|Change From Baseline in Six Minute Walk Distance (6MWD) in Meters|"6MWD measured the distance in meters a participant was able to walk in 6 minutes. The study used 6MWD procedure modified specifically for use in boys with Duchenne muscular dystrophy (DMD), including standardized verbal encouragement at specific intervals to maintain attention to the test, and use of a safety chaser to walk behind the participant during testing (McDonald et al., 2010a). The LS mean (LSM) change from baseline, standard error was derived using mixed model repeated measures (MMRM) methodology with factors for pooled country, treatment, visit, treatment-by-visit interaction and baseline 6MWD as a covariate."|Baseline, Week 48|All randomized participants who received at least one dose of study drug who had a baseline and at least one post-baseline measurement.||Meters||Standard Error|Least Squares Mean
660147|NCT01864538|Primary|Overall Survival||1 year|||Participants|||Count of Participants
660148|NCT01864434|Primary|Kinematics - Ramp Down Activity|Lateral Anterior Posterior (LAP) [during 3 moments - 0-33%, 33-66% and 66-100%] and Medial Anterior Posterior (MAP) [during 3 moments - 0-33%, 33-66% and 66-100%] translations, and Axial Rotation (AR) [during 3 moments - 0-33%, 33-66% and 66-100%] of medial femoral condyles during ramp down activity|3 months post-operative|||mm||Standard Deviation|Mean
660149|NCT01864434|Primary|Kinematics - Ramp up Activity|Lateral Anterior Posterior (LAP) [during 3 moments - 0-33%, 33-66% and 66-100%] and Medial Anterior Posterior (MAP) [during 3 moments - 0-33%, 33-66% and 66-100%] translations, and Axial Rotation (AR) [during 3 moments - 0-33%, 33-66% and 66-100%] of medial femoral condyles during ramp up activity|3 months post-operative|||mm||Standard Deviation|Mean
660150|NCT01864434|Primary|Kinematics - Deep Knee Bend Activity|Lateral Anterior Posterior (LAP) and Medial Anterior Posterior (MAP) translations, and Axial Rotation (AR) and maximum flexion of medial femoral condyles during deep knee bend (DKB) activity|3 months post-operative|||mm||Standard Deviation|Mean
660151|NCT01864174|Primary|Number of Participants With Death, Serious Adverse Events (SAEs), SAEs Related to Study Therapy, SAEs Leading to Discontinuation, Adverse Events (AEs) Related to Study Therapy, and AEs Leading to Discontinuation|SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Treatment-related=having certain, probable, possible, or missing relationship to study drug. All listed events are treatment emergent, which is defined as nonserious and serious AEs with an onset from Day 1 of the double-blind treatment up to and including 4 days and 30 days respectively, after the last dose date of double-blind study. randomized.|Date of first dose (Day 1) up to 30 post last dose of study drug (approx. 28 weeks)|Treated participants; All participants who took at least one dose of double-blind study medication in the treatment group they were randomized to unless participants had never received the double-blind study medication they were randomized. Those participants were included in the treatment group based on the first treatment received.||participants|||Number
660152|NCT01864174|Secondary|Percent of Participants With HbA1c < 7%|Percent of participants achieving a therapeutic glycemic response (defined as HbA1c < 7.0%) at Week 24 in the double-blind treatment period.|Week 24|Randomized participants who took at least one dose of double-blind study medication in the treatment group to which they were randomized with non-missing baseline and Week 24 values who were not excluded due to non-compliance.||percent of participants||95% Confidence Interval|Number
660153|NCT01864174|Secondary|Mean Change in Mean Daily Glucose (MDG)|The mean change in Mean Daily Glucose (MDG) from baseline to Week 24 in the double-blind treatment period was assessed. Prior to the Day 1 visit (between Week -1 and Day 1) and in the week before the Week 24/Study Termination and Rescue or Early Treatment Termination visit, participants performed 7-point finger stick blood glucose monitoring (before and 2 hours after 3 meals per day, and at bedtime) for 3 consecutive days in order to determine their MDG.|Baseline and Week 24|Randomized participants who took at least one dose of double-blind study medication in the treatment group to which they were randomized with non-missing baseline and Week 24 last observation carried forward (LOCF) results who were not excluded due to non-compliance.||mg/dL||Standard Error|Mean
660154|NCT01864174|Secondary|Mean Change in Fasting Plasma Glucose (FPG)|The mean change in fasting plasma glucose (FPG) from baseline to Week 24 in the double-blind treatment period was assessed. The lack of glycemic control criteria for initiation of rescue medication during Week 12 to Week 24 was having a FPG > 200 mg/dL (11.1 mmol/L). mg/dL = milligrams per deciliter; mmol/L = millimole per Liter|Baseline and Week 24|Randomized participants who took at least one dose of double-blind study medication in the treatment group to which they were randomized with non-missing baseline and Week 24 values and who were not excluded due to non-compliance.||mg/dL||Standard Error|Mean
660155|NCT01864174|Primary|Adjusted Mean Change From Baseline in HbA1c|Mean change in glycated hemoglobin (HbA1c) from baseline to Week 24 in the double-blind treatment period.|Baseline and Week 24|Randomized participants who took at least one dose of double-blind study medication in the treatment group to which they were randomized with non-missing baseline and Week 24 values who were not excluded due to non-compliance.||percent||Standard Error|Mean
660156|NCT01864148|Secondary|Pharmacokinetics: BIIB033 Plasma Concentrations up to Week 84||Up to 84 weeks|PK Population: participants who received at least 1 dose of BIIB033 and had at least 1 serum concentration data point on record.||µg/mL||Standard Deviation|Mean
660157|NCT01864148|Secondary|Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) and Discontinuations Due to AEs|An AE was any untoward medical occurrence that did not necessarily have a causal relationship with this treatment. An SAE was any untoward medical occurrence that at any dose: resulted in death; in the view of the Investigators, placed the participant at immediate risk of death (a life-threatening event); however, this did not include an event that, had it occurred in a more severe form, might have caused death; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigators, could have jeopardized the participant or may have required intervention to prevent one of the other outcomes listed in the definition above.|Up to 84 weeks|Safety Population: all participants who received at least 1 dose of study treatment.||participants|||Number
660158|NCT01864148|Secondary|Proportion of Participants Confirmed as Worsening Responders for Primary Multicomponent Endpoint|Estimated proportion of participants experiencing confirmed clinical worsening in 1 or more components of the multicomponent endpoint (EDSS, T25FW, 9HPT, or PASAT-3) over 72 weeks, defined as: a ≥1.0 point increase in EDSS from a baseline score of ≤5.5 or a ≥0.5 point increase from a baseline score equal to 6.0 (increase sustained for 3 months or greater); a ≥15%worsening from baseline in time to complete T25FW test (worsening sustained for 3 months or greater), where the time is the average of 2 trials at the same visit; a ≥15% worsening from baseline in time to complete 9HPT by either hand (worsening sustained for 3 months or greater for the same hand), where the time is the average of 2 trials for each hand at the same visit; a ≥15% worsening from baseline in PASAT-3 score (worsening sustained for 3 months or greater). Estimated proportion of responders is based on logistic regression adjusted for MS type, region and baseline component assessments.|72 weeks|Intent-to-treat population: all randomized participants who received at least 1 dose of study treatment and included in the efficacy analysis (6 participants were excluded due to study site Good Clinical Practice deviation).||proportion of participants|||Number
660182|NCT01863433|Secondary|Type and Frequency of Any Unsolicited AEs|The percentage of participants reporting any unsolicited AEs. Unsolicited AEs included AEs other than those specifically solicited.|After vaccination until the end of the study; approximately 21 days.|The Safety Population included all participants who received Trivalent Influenza Vaccine and provided follow-up safety data.||percentage of participants|||Number
660183|NCT01863433|Secondary|Type and Frequency of Any Solicited Adverse Events (AEs)|The percentage of participants reporting any solicited AEs.|During the 4 days after vaccination (Day 0 plus 3 days)|The Safety Population included all participants who received Trivalent Influenza Vaccine and provided follow-up safety data.||percentage of participants|||Number
661578|NCT01837797|Secondary|Remission During the Randomised Treatment|Based on a pre-specified MADRS total score|From randomisation to end of treatment|Only 3 patients completed study Period 2. A total of 129 patients were enrolled when the study was terminated (Planned: 1334 patients).|||||
660159|NCT01864148|Primary|Proportion of Participants Confirmed as Improvement Responders for Primary Multicomponent Endpoint|Estimated proportion of participants experiencing confirmed improvement in any 1 or more of the following components: a ≥1 point decrease in the Expanded Disability Status Scale (EDSS) score from a baseline score of <=6.0 (decrease sustained for ≥3 months); a ≥15% improvement from baseline in time to complete 9-Hole Peg Test (9HPT) by either hand (improvement sustained for ≥3 months for the same hand), where the time is the average time of 2 trials per hand at the same visit; a ≥15% improvement from baseline in time to complete Timed 25-Foot Walk (T25FW) test (improvement sustained for ≥3 months), where the time is the average time of 2 trials at the same visit; or a ≥15% improvement from baseline 3-Second Paced Auditory Serial Addition Test (PASAT-3) score (improvement sustained for 3 months or greater). Estimated proportion of responders is based on logistic regression adjusted for multiple sclerosis (MS) type, region and baseline component assessments.|72 weeks|Intent-to-treat population: all randomized participants who received at least 1 dose of study treatment and included in the efficacy analysis (6 participants were excluded due to study site Good Clinical Practice deviation).||proportion of participants|||Number
660160|NCT01864005|Secondary|the Percentage Inhibition of the P2Y12 Receptor||at 6 weeks after first dose of study drug|PPS (per-protocol set). Seven randomized patients were excluded from PPS due to any of the following reasons: 1) did not meet exclusion requirments but was randomized, 2)post-treatment blood PRU was not available, 3) pre-treatment blood PRU was missing, 4) missing blood PRU at 2h after first dose, and 5) use of prohibited medications.||Percentage Inhibition||Standard Deviation|Mean
660161|NCT01864005|Secondary|the Percentage Inhibition of the P2Y12 Receptor||at 24 hours after first dose of study drug|PPS (per-protocol set). Seven randomized patients were excluded from PPS due to any of the following reasons: 1) did not meet exclusion requirments but was randomized, 2)post-treatment blood PRU was not available, 3) pre-treatment blood PRU was missing, 4) missing blood PRU at 2h after first dose, and 5) use of prohibited medications.||Percentage Inhibition||Standard Deviation|Mean
660162|NCT01864005|Secondary|the Percentage Inhibition of the P2Y12 Receptor||at 8 hours after first dose of study drug|PPS (per-protocol set). Seven randomized patients were excluded from PPS due to any of the following reasons: 1) did not meet exclusion requirments but was randomized, 2)post-treatment blood PRU was not available, 3) pre-treatment blood PRU was missing, 4) missing blood PRU at 2h after first dose, and 5) use of prohibited medications.||Percentage Inhibition||Standard Deviation|Mean
660163|NCT01864005|Secondary|the Percentage Inhibition of the P2Y12 Receptor||at 0.5 hour after first dose of study drug|PPS (per-protocol set). Seven randomized patients were excluded from PPS due to any of the following reasons: 1) did not meet exclusion requirments but was randomized, 2)post-treatment blood PRU was not available, 3) pre-treatment blood PRU was missing, 4) missing blood PRU at 2h after first dose, and 5) use of prohibited medications.||Percentage Inhibition||Standard Deviation|Mean
660164|NCT01864005|Primary|the Percentage Inhibition of the P2Y12 Receptor|Note: the primary endpoint was changed per the statistical analysis plan prior database lock.|at 2 hours after first dose of study drug|FAS (full analysis set). Three randomized patients were excluded from FAS due to any of the following reasons: 1) did not meet exclusion requirments but was randomized, 2)post-treatment blood PRU was not available, 3) pre-treatment blood PRU was missing, and 4) use of prohibited medications.||Percentage Inhibition||Standard Deviation|Mean
660165|NCT01863953|Secondary|Average Eye Mean Diurnal IOP|IOP is a measurement of the fluid pressure inside the eye. Average eye mean diurnal IOP is the mean of the average eye IOPs (average IOP of the right and left eyes) at hours 0, 2, 4, 8 and 12.|Day 14, Day 28, Day 42|Modified Intent to Treat: all randomized and treated patients who had baseline and at least 1 postbaseline IOP assessment||mmHg||Standard Deviation|Mean
660166|NCT01863953|Secondary|Change From Baseline in Average Eye Mean Diurnal IOP|IOP is a measurement of the fluid pressure inside the eye. Average eye mean diurnal IOP is the mean of the average eye IOPs (average IOP of the right and left eyes) at hours 0, 2, 4, 8 and 12. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase in IOP (worsening).|Baseline, Day 14, Day 28|Modified Intent to Treat: all randomized and treated patients who had baseline and at least 1 postbaseline IOP assessment||mmHg||Standard Deviation|Mean
660167|NCT01863953|Primary|Change From Baseline in Average Eye Mean Diurnal Intraocular Pressure (IOP)|IOP is a measurement of the fluid pressure inside the eye. Average eye mean diurnal IOP is the mean of the average eye IOPs (average IOP of the right and left eyes) at hours 0, 2, 4, 8 and 12. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase in IOP (worsening).|Baseline, Day 42|Modified Intent to Treat: all randomized and treated patients who had baseline and at least 1 postbaseline IOP assessment||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
660168|NCT01863771|Secondary|Number of Participants With Mucosal Healing at Both Maintenance-Week 30 and Week 54|Mucosal healing is defined as an endoscopy subscore of 0 or 1, where 0 indicates normal or inactive disease and 1 indicates mild disease (erythema, decreased vascular pattern, mild friability). Endoscopy subscore is one of the 4 subscores of the Mayo score.|Weeks 30 and 54|Efficacy full analysis set for maintenance phase included all participants who responded to golimumab induction treatment and subsequently randomized at Week 0 in maintenance phase. Data for this outcome was not planned to be analyzed for participants who had not responded to golimumab induction dosing, as pre-specified in protocol.||participants|||Number
660169|NCT01863771|Secondary|Number of Participants Who Achieved Clinical Remission at Both Maintenance-Week 30 and Week 54|Clinical remission (as measured by the Mayo score) was defined as a Mayo score of less than or equal to (<=) 2 points, with no individual sub-score greater than (>) 1.|Weeks 30 and 54|Efficacy full analysis set for maintenance phase included all participants who responded to golimumab induction treatment and subsequently randomized at Week 0 in maintenance phase. Data for this outcome was not planned to be analyzed for participants who had not responded to golimumab induction dosing, as pre-specified in protocol.||participants|||Number
660184|NCT01863433|Primary|The Percentage of Evaluable Participants Achieving a HI Titre ≥ 40 or Single Radial Haemolysis (SRH) Area ≥ 25 mm2.|For the H1N1, H3N2, and B influenza virus strains. Note: No SRH data were collected.|Approximately 21 days after vaccination|The Evaluable Population includes all participants who were vaccinated with Trivalent Influenza Vaccine, provided both pre- and post-vaccination antibody titre results, did not use a prohibited medication as per the protocol, and were not excluded from the analysis according to the elimination criteria.||percentage of participants||95% Confidence Interval|Number
660170|NCT01863771|Primary|Number of Participants Who Achieved Clinical Response Through Maintenance-Week 54 Measured Using the Mayo Score|Clinical response was defined as a decrease from Induction-Week 0 in the Mayo score by greater than or equal to (>=) 30 percent and >=3 points, with a decrease in the rectal bleeding subscore of >= 1 or a rectal bleeding subscore of 0 or 1. The Mayo score is the primary tool for assessing ulcerative colitis activity. The Mayo score consists of 4 subscores (stool frequency, rectal bleeding, findings of endoscopy, and physician's global assessment) which range from 0 to 3. The Mayo score is calculated as the sum of these 4 subscores and can range between 0 and 12. A score of 3 to 5 points indicates mildly active disease; a score of 6 to 10 indicates moderately active disease; and a score of 11 to 12 indicates severe disease.|Up to Week 54|Efficacy full analysis set for maintenance phase included all participants who responded to golimumab induction treatment and subsequently randomized at Week 0 in maintenance phase. Data for this outcome was not planned to be analyzed for participants who had not responded to golimumab induction dosing, as pre-specified in protocol.||participants|||Number
660171|NCT01863680|Secondary|Serum Progesterone Level|Two pharmacokinetic (PK) samples were collected per subject for the measurement of serum progesterone concentrations; 1st sample at Visit 2-2 (prior to hCG administration) and second sample during Visit 5 (Day 14+/-3, 7 hours after the morning of investigational medicinal product administration).|Visit 2-2 (Prior to hCG administration) and Visit 5 (Day 14+/-3)|"The PK analysis set included all subjects who had serum beta-hCG pregnancy test performed at Visit 5 (Day 14+/-3), who had two progesterone concentrations at Visit 2-2 and Visit 5, and who had no relevant problems for compliance of administration until Visit 5. n signifies the number of subjects who were evaluable in each category, respectively."||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
660172|NCT01863680|Secondary|Biochemical Pregnancy Rate Per Embryo Transfer|Biochemical pregnancy was defined as any miscarriage without any evidence of a fetal sac on TVUS during Visit 6 (Week 5), but with a positive serum beta-hCG pregnancy test result at Visit 5 (Day 14+/-3). Biochemical pregnancy rate was calculated as the number of subjects who had no fetal sac observed during Visit 6 (Week 5) TVUS assessment or subjects who had a positive serum pregnancy test at Visit 5 (Day 14+/-3) and no data recorded at Visit 6 (Week 5) divided by the number of subjects who has at least 1 embryo transferred.|Week 5 post embryo transfer (2-6 days after Ovum Pick-up [OPU])|The intention-to-treat subjects included all the subjects who underwent IVF/ET.||Percentage of pregnancy/embryo transfer|||Number
660173|NCT01863680|Primary|Clinical Pregnancy Rate Per Embryo Transfer|Clinical pregnancy was defined as the presence of a fetal sac on transvaginal ultrasound (TVUS) during Week 5 or the presence of an extra-uterine pregnancy (as confirmed during surgery or by 2 positive serum beta-human chorionic gonadotropin (beta-hCG) results from Week 5). The clinical pregnancy rate was calculated as number of subjects who were clinically pregnant divided by the number of subjects who had at least 1 embryo transferred.|Week 5 post embryo transfer (2-6 days after Ovum Pick-up [OPU])|The intention-to-treat subjects included all the subjects who underwent IVF/ET.||Percentage of pregnancy/embryo transfer|||Number
660174|NCT01863667|Secondary|Change From Baseline in Body Weight at Week 54|Body weight was to be measured (in duplicate) using a calibrated digital scale.|Baseline and Week 54|All participants as treated defined as all randomized participants who received at least one dose of study drug and were included in the treatment group corresponding to the study drug they actually received. Due to the early termination of the study, no participants completed Week 54.|||||
660175|NCT01863667|Secondary|Percentage of Participants With an Adverse Event of Symptomatic Hypoglycemia|An adverse event (AE) is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. AEs may include the onset of new illness and the exacerbation of pre-existing conditions. Per protocol, an adverse event was defined as symptomatic hypoglycemia if hypoglycemia was an adverse event collected on the AE form AND the symptoms associated with it were collected on the hypoglycemia assessment (HA) form. Due to the early termination of the study, the HA form information was not assessed; therefore, this endpoint cannot be reported.|Up to 54 weeks|All participants as treated defined as all randomized participants who received at least one dose of study drug and were included in the treatment group corresponding to the study drug they actually received.|||||
660176|NCT01863667|Secondary|Percentage of Participants Meeting the Composite Endpoint of an A1C Decrease >0.5%, No Symptomatic Hypoglycemia, and No Body Weight Gain After 54 Weeks of Treatment|Percentage of Participants who had an A1C decrease >0.5%, no symptomatic hypoglycemia, and no body weight gain after 54 weeks of treatment|54 weeks|Full Analysis Set defined as all participants who received at least one dose of study drug and had a baseline measurement or a post-randomization measurement. Due to the early termination of the study, no participants completed Week 54.|||||
660177|NCT01863667|Secondary|Percentage of Participants Achieving an A1C Goal <7.0% or <6.5% After 54 Weeks of Treatment|Percentage of participants achieving glycemic goal (A1C <7% or <6.5%) after 54 weeks of treatment.|54 weeks|Full Analysis Set defined as all participants who received at least one dose of study drug and had a baseline measurement or a post-randomization measurement. Due to the early termination of the study, no participants completed Week 54.|||||
660178|NCT01863667|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 54|This change from baseline reflects the FPG level at Week 54 minus the FPG level at Week 0.|Baseline and Week 54|Full Analysis Set defined as all participants who received at least one dose of study drug and had a baseline measurement or a post-randomization measurement. Due to the early termination of the study, no participants completed Week 54.|||||
660179|NCT01863667|Primary|Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event|An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of pre-existing conditions.|Up to 54 weeks|All participants as treated defined as all randomized participants who received at least one dose of study drug and were included in the treatment group corresponding to the study drug they actually received.||Percentage of participants|||Number
660202|NCT01862133|Primary|Providers' Opinion of Patients' Controlling EHR Access|"Percent of providers answering Strongly Agree or Agree to the following question on the post-study survey: I think it is OK for patients to have control over who sees what information in their electronic health records."|6 month study||03/2015||||
661777|NCT01833988|Secondary|Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Time Spent in Hypoglycemia (Plasma BG <Than 70 mg/dl) at Night||1 week|||percentage of time||Standard Deviation|Mean
660185|NCT01863433|Primary|The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination.|GMFI (H1N1, H3N2, and B influenza virus strains) is defined as the geometric mean of the fold increases of post-vaccination antibody titre over the pre-vaccination antibody titre.|Approximately 21 days after vaccination|The Evaluable Population includes all participants who were vaccinated with Trivalent Influenza Vaccine, provided both pre- and post-vaccination antibody titre results, did not use a prohibited medication as per the protocol, and were not excluded from the analysis according to the elimination criteria.||fold increase||Standard Deviation|Geometric Mean
660186|NCT01863433|Primary|The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre.|As per the criteria specified in the CPMP/BWP/214/96 Note for Guidance on Harmonisation of Requirements for Influenza Vaccines. For haemagglutination inhibition (HI), seroconversion (H1N1, H3N2, and B influenza virus strains) is defined as achieving a post-vaccination titre of ≥ 40 for those participants with a pre-vaccination HI titre of < 10. A significant increase (H1N1, H3N2, and B influenza virus strains) is defined as a four-fold or greater increase in HI titre for those participants with a pre-vaccination HI titre of ≥ 10.|Approximately 21 days after vaccination|The Evaluable Population includes all participants who were vaccinated with Trivalent Influenza Vaccine, provided both pre- and post-vaccination antibody titre results, did not use a prohibited medication as per the protocol, and were not excluded from the analysis according to the elimination criteria.||percentage of participants||95% Confidence Interval|Number
660187|NCT01863368|Secondary|Mean Impact of Dry Eye on Everyday Life (IDEEL) Treatment Inconvenience Score at Day 35 (Phase I)|The IDEEL is a 10-item, patient-reported questionnaire used to measure treatment satisfaction. The subject answered 4 questions pertaining to treatment inconvenience scored on a 0-4 Likert-type scale, where 0=All of the time, 1=Most of the time, 2=Some of the time, 3=A little of the time, and 4=None of the time. The IDEEL score for treatment inconvenience was calculated based upon the mean value of the 4 questions multiplied by 25, for a resultant overall score of 0-100, where 0=Complete disability and 100=No disability. Both eyes contributed to the analysis.|Day 35|This analysis group includes all subjects with data at visit.||units on a scale||Standard Deviation|Mean
660188|NCT01863368|Secondary|Mean Impact of Dry Eye on Everyday Life (IDEEL) Treatment Effectiveness Score at Day 35 (Phase I)|The IDEEL is a 10-item, patient-reported questionnaire used to measure treatment satisfaction. The subject answered 4 questions pertaining to treatment effectiveness scored on a 0-4 Likert-type scale, where 0=None of the time, 1=A little of the time, 2=Some of the time, 3=Most of the time, and 4=All of the time. The IDEEL score for treatment effectiveness was calculated based upon the mean value of the 4 questions multiplied by 25, for a resultant overall score of 0-100, where 0=Complete disability and 100=No disability. Both eyes contributed to the analysis.|Day 35|This analysis group includes all subjects with data at visit.||units on a scale||Standard Deviation|Mean
660189|NCT01863368|Secondary|Mean Ocular Surface Disease Index (OSDI) Score at Day 35 (Phase I)|The OSDI is a 12-item, quality of life questionnaire that evaluates symptoms based on 3 modules (type of discomfort, environmental triggers, and tasking) on a 0-4 Likert scale (0=None of the time, 4=All of the time). A resultant overall 0-100 score was calculated, where 0=No disability and 100=Complete disability. Both eyes contributed to the analysis.|Day 35|This analysis group includes all subjects with data at visit.||units on a scale||Standard Deviation|Mean
660190|NCT01863368|Primary|Mean Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 35 (Phase I)|The TOSS score is a composite score of corneal fluorescein staining, nasal conjunctival lissamine green staining, and temporal conjunctival lissamine green staining, each scored on a 0-5 Likert scale (0=absent, 5=severe). TOSS scores can range from 0 to 15. One eye (study eye) contributed to the analysis.|Baseline, Day 35|This analysis group includes all randomized subjects with data at visit.||units on a scale||Standard Deviation|Mean
660191|NCT01863134|Primary|Major Adverse Cardiac and Cerebrovascular Events (MACCE)|MACCE was defined as combined death, nonfatal myocardial infarction, cerebrovascular event (stroke) and the need for re-hospitalization due to recurrent ischemia up to 12 months follow-up|Up to 12 month|||Percentage of study group|||Number
660192|NCT01862991|Secondary|Adverse Events|Uterine perforation|Intraoperatively and 2 weeks post operatively|||Participants|||Count of Participants
660193|NCT01862991|Primary|Procedure Time|Measured as time from speculum insertion to removal|Intraoperative Time, Collected immediately within procedure|||minutes||Full Range|Median
660194|NCT01862484|Primary|ADHD Rating Scale IV|The ADHD Rating Scale is an 18 items scale containing items related to the diagnosis of Attention Deficit Hyperactivity Disorder (ADHD). It is filled out by the parent. Each item is rated 0-3, the range of scores is 0 to 54, with 25 being the score below which the patient is considered to be in remission. Reference: DuPaul GJ, Power TJ, Anastopoulos AD, Reid R: ADHD Rating Scales-IV: Checklists, Norms and Clinical Interpretation. New York, Guilford Press; 1998.|5 weeks|Children with ADHD who completed the five week diet and parents filled out the ADHD rating scale.||units on a scale||Standard Deviation|Mean
660195|NCT01862419|Primary|Relative Maximum Change in Creatinine||7 days of randomization|||relative percent change||Inter-Quartile Range|Median
660196|NCT01862419|Primary|Death||7 days of randomization|||participants|||Number
660197|NCT01862419|Primary|Dialysis Within 7 Days|This metric will be sequentially ranked. The provision of acute dialysis therapy will be ranked as a more severe outcome than the worst relative change in creatinine and death will be ranked as a more severe outcome than dialysis.|From start of AKI to 7 days later|||participants|||Number
660198|NCT01862159|Secondary|Specific Postoperative Complications|Any complication (Anastomotic leakage/abscesses, bleeding, small bowel obstruction, stomal ulcera, cardiovascular complications, pulmonary complications, venous thromboembolism, port site complication, other complication)|30 days or the postoperative hospital stay if longer than 30 days|||Participants|||Count of Participants
660199|NCT01862159|Secondary|Length of Stay|Length of stay after the primary operation|30 days or the postoperative hospital stay if longer than 30 days|||days||Standard Deviation|Mean
660200|NCT01862159|Secondary|Operating Time|length of the operation|operation|||minutes||Standard Deviation|Mean
660201|NCT01862159|Primary|Serious Complications|Graded as Clavien 3b or more (for patients entered in the registry after January 1st 2010)|30 days or the postoperative hospital stay if longer than 30 days|All patients operated after Jan 1, 2010||Participants|||Count of Participants
663856|NCT01797029|Secondary|The Clinical Characteristics of Influenza, Including Influenza Co-infections With Other Bacterial and Viral Respiratory Pathogens||Through 16 to 19 months post-vaccination||||||
660203|NCT01862133|Primary|Number of Patients Recording Preferences to Restrict Provider Access to Some or All EHR Data|"Patients had to restrict access to either all data or one of five categories of sensitive data (sexually transmitted infections, HIV/AIDS, sexual health and pregnancy, drug and alcohol use and abuse, and mental health information) to one or more of the study providers."|6 month study|All patients recorded their preferences and completed the questionnaire. 24 (77%) of the 31 providers completed the anonymous post-study questionnaire.||participants|||Number
660204|NCT01861925|Post-Hoc|Equivalence of Keratometry Axis Measurement Between Lenstar LS 900 Topography and Lenstar LS 900: Population Mean of Normalized Differences of Keratometry Axis Measurement Between Both Devices.|"For definition of keratometry axis see outcome measures 4 and 5.
This outcome measure aims at testing the equivalence of keratometry axis measurement between Lenstar LS 900 Topography and Lenstar LS 900 (both Haag Streit) by analyzing differences in measurement results for the same eye between both devices.
Reported are: population mean of normalized difference and 95% confidence interval of mean normalized difference for axis of flat meridian.
Difference is normalized for each eye as function of astigmatism to a refractive error of 0.167 diopters (i.e. an axis difference of 1 normalized degree results in a refractive error of 0.167 diopter), to provide a measure which can be directly related to its impact on visual quality.
Please note that for this analysis a separation in arms normal eye and large regular astigmatism is not meaningful, thus here both groups are analyzed jointly as group regular eye"|1 day of examination|||normalized degree||95% Confidence Interval|Mean
660205|NCT01861925|Other Pre-specified|Equivalence of Keratometry Axis Measurement Between Lenstar LS 900 Topography and Lenstar LS 900: Population Mean of Differences of Keratometry Axis Measurement Between Both Devices.|"Keratometry axis refers to the axis of the flat meridian of the toric representation of the cornea. For additional information see outcome 4.
This outcome measure aims at testing the equivalence of keratometry axis measurement between Lenstar LS 900 Topography and Lenstar LS 900 (both Haag Streit) by analyzing differences in measurement results for the same eye between both devices.
Reported are: population mean of difference and 95% confidence interval of mean difference for axis of flat meridian."|1 day of examination|||degree||95% Confidence Interval|Mean
660206|NCT01861925|Other Pre-specified|Equivalence of Keratometry Radius Measurement Between Lenstar LS 900 Topography and Lenstar LS 900: Population Mean of Differences of Keratometry Radius Measurement Between Both Devices.|"Keratometry radius refers to the corneal curvature R (see primary measure outcome). In this context, the cornea is approximated by a toric surface which can be characterized by a flat meridian (radius R1) and a steep meridian (radius R2) with an angle of 90 degrees between these meridians.
This outcome measure aims at testing the equivalence of keratometry radius measurement between Lenstar LS 900 Topography and Lenstar LS 900 (both Haag Streit) by analyzing differences in measurement results for the same eye between both devices.
Reported are: population mean of difference and 95% confidence interval of mean difference for radius of flat meridian (R1) and radius of steep meridian (R2)."|1 day of examination|||micrometer||95% Confidence Interval|Mean
660207|NCT01861925|Other Pre-specified|Equivalence of Corneal Topography Measurement Between Lenstar LS 900 Topography and Atlas 9000: Sample Mean of Std. Dev. of Local Corneal Elevation Differences for One Measurement Per Device.|"For definition of corneal topography, areas of evaluation and methods, see outcome 1 and 2.
Corneal elevation refers to the distance between the measured corneal surface and the best fitting sphere, and is given in µm.
This outcome measure aims at testing the equivalence of corneal topography measurement between Lenstar LS 900 Topography (Haag Streit) and Atlas 9000 (Zeiss) by analyzing differences in measurement results for the same eye between both devices.
elevation difference (2 std. dev.) is the sample mean of twice the standard deviation of local corneal elevation differences between measurements with both devices. This value quantifies the spatially resolved agreement of corneal shape measurement of the two devices."|1 day of examination|||micrometer||95% Confidence Interval|Mean
660208|NCT01861925|Secondary|Equivalence of Corneal Topography Measurement Between Lenstar LS 900 Topography and Atlas 9000: Sample Mean of Differences of Mean Power and Sample Mean of Std. Dev of Local Power Differences for One Measurement Per Device.|"For definition of corneal topography, corneal power in diopter, areas of evaluation and methods, see outcome 1.
This outcome measure aims at testing the equivalence of corneal topography measurement between Lenstar LS 900 Topography (Haag Streit) and Atlas 9000 (Zeiss) by analyzing differences in measurement results for the same eye between both devices.
power difference (2 devices) is the sample mean and 95% C.I. of differences of spatial mean of corneal power between two devices. This value quantifies systematic differences between devices (e.g. calibration), ignoring local variations of the power measurement.
power difference (2 std.dev.) is the sample mean of twice the standard deviation of local power differences between measurements with both devices. This value quantifies the spatially resolved agreement of corneal shape measurement of the two devices."|1 day of examination|||diopters||95% Confidence Interval|Mean
660209|NCT01861925|Primary|In-vivo Repeatability of Corneal Topography Measurements With Lenstar LS 900 Topography: Sample Mean of Differences of Mean Power and Sample Mean of Std. Dev of Local Power Differences Between Two Consecutive Measurements|"Corneal topography is a measurement of the shape of the anterior cornea. The shape of a cornea can be fully quantified by providing a map of local power. Diopter is the unit of refractive power of a lens. In case of the cornea, the power K [diopter] is related to the radius (curvature) R [mm] of the best fitting sphere by the relation K=337.5/R.
Here, corneal topography measurements are implemented by the Placido method, i.e. by analyzing the reflection image of a ring-shaped illumination.
According to International Standards Organization (ISO) 19980-2012, repeatability of corneal topography is assessed on the central cornea: area with diameter d<=3mm, and middle cornea: 3mm<d<=6mm.
power difference (2 rep. meas.): sample mean and 95% C.I. of differences of spatial mean of corneal power between two consecutive measurements.
power difference 2 std.dev.: sample mean of twice the deviation of local power differences (two consecutive measurements)."|1 day of examination|||diopters||95% Confidence Interval|Mean
660210|NCT01861756|Secondary|Glycemic Control (HbA1c)||3 and 6 months after patient initial encounter||||||
660211|NCT01861756|Secondary|Adherence With Antihyperglycemic Regimens as Reported by the Patient Himself/Herself or Assessed Utilizing the Pharmacy Records||3 and 6 months after patient initial encounter||||||
660265|NCT01860586|Other Pre-specified|Intravitreal Bevacizumab Injections Impact on Visual Acuity Score (Change in Letters Read).|Increase or decrease in amount of letters read after intravitreal bevacizumab injections versus control patient that did not receive injections of intravitreal bevacizumab.|6 months|Final logMAR visual acuity of patients treated with bevacizumab||logMAR visual acuity||Standard Deviation|Mean
660212|NCT01861756|Secondary|Patient and Clinician Satisfaction With the Decision Making Process|"Patient satisfaction will be assessed using items from the Decisional Conflict Scale as well as two specific questions that require patients to assess the extent to which they would want for themselves and recommend to others similar decision support.
Clinician satisfaction will be assessed using a 6-point likert-type question asking about their satisfaction regarding the discussion they had with their patient."|Day 1||||||
660213|NCT01861756|Secondary|Degree of Patient Knowledge About Available Treatment Alternatives|Patients will complete a 6-item questionnaire addressing general knowledge about type 2 diabetes.|Day 1||||||
660214|NCT01861756|Primary|Overall Decisional Comfort (0-100, 100=no Conflict)|Quality of the decision making process assessed by means of the Decisional Conflict Scale|Day 1|||units on a scale||95% Confidence Interval|Mean
660215|NCT01861704|Secondary|Gain, Speech Understanding and Sound Quality||During useful lifespan of device||||||
660216|NCT01861704|Secondary|Device Comfort||During useful lifespan of device||||||
660217|NCT01861704|Primary|Immediate Refit Upon Device Removal|Upon device removal, a qualified audiologist examined subjects’ ears to evaluate their availability to be immediately refit with another hearing aid device. It is not uncommon for patients being fitted with these types of devices to experience slight irritation on an initial experience with the device. In particular, those being fit with the Lyric or Lyric2.0 for the first time first undergo the device sizing process, which slightly increases stress on the ear.|Following device removal at the same appointment (Up to 24 hours after removal)|Only ears from experienced users were taken into account, i.e. only users that have previously worn an extended wear device. Some patients previously worn only one hearing instrument, therefor a significant number of patients were only fitted with one instrument||percentage of ears|Participants|90% Confidence Interval|Number
660218|NCT01861522|Secondary|Adverse Events and Adverse Drug Reactions||Week 2||||||
660219|NCT01861522|Secondary|Change From Baseline in Severity Score for Symptoms of Allergic Rhinitis||Randomization, Week1 and Week 2||||||
660220|NCT01861522|Secondary|Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings)||baseline, Week1 and Week 2||||||
660221|NCT01861522|Secondary|Change From Baseline in Individual Nasal Symptom Scores (Sneezing, Rhinorrhea, Nasal Congestion, and Impairment in Daily Activities)||baseline, Week1 and Week 2||||||
660222|NCT01861522|Secondary|Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion]||baseline, Week1 and Week 2||||||
660223|NCT01861522|Primary|Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion]|Total score for the three major nasal symptoms (sneezing, rhinorrhea, and nasal congestion) were rated on 5-point scale ranging from 0 (no symptoms) to 4 (very severe).|Baseline and Week 2|||units on a scale||Standard Error|Least Squares Mean
660224|NCT01861457|Secondary|Treatment-associated Change in Total Nasal Bacterial Colonization During a Typical 10-hour Work Day|The percent change from morning baseline sample to the evening sample taken at the end of a typical 10-hour workday in treated subjects known to be colonized by Staph aureus.|10 hour workday|||Percent change in colonization||Inter-Quartile Range|Median
660225|NCT01861457|Primary|Treatment-associated Change in S. Aureus Colonization During a Typical 10-hour Work Day|The percent change from morning baseline sample to the evening sample taken at the end of a typical 10-hour workday in treated subjects known to be colonized by Staph aureus.|10-hour work day|All participants who received 3 scheduled treatments||Percent change in colonization||Inter-Quartile Range|Median
660226|NCT01861301|Other Pre-specified|Association Between Baseline HGF, MET Gene Amplification, MET IHC and PFS|Will be evaluated using the Cox regression model.|Baseline to 1 year||||||
660227|NCT01861301|Other Pre-specified|Change in Serum HGF or MET IHC and Tumor Size Change (Percent Reduction in Sum of Longest Diameters)|Will be evaluated by Spearman’s rank correlation coefficient.|Baseline to 1 year||||||
660228|NCT01861301|Other Pre-specified|Change in Baseline Levels of Continuous or Ordinal Markers (e.g., Serum HGF/MET IHC) Between Responders and Non-responders|Fisher’s exact test will be performed for binary variables (e.g., presence/absence of MET gene amplification). Paired t-tests or Wilcoxon signed-ranks test, whichever is appropriate, will be used to examine the changes with treatment in the laboratory correlates that are continuous and McNemar’s test will be used for binary markers.|Baseline to 1 year||||||
660229|NCT01861301|Secondary|Progression-free Survival|Time to disease progression or death from any cause. Analyzed using the Kaplan-Meier method.|Up to 2 years|||Months||95% Confidence Interval|Median
660230|NCT01861301|Secondary|Overall Survival|Analyzed using the Kaplan-Meier method.|Up to 2 years|||Months||95% Confidence Interval|Median
660231|NCT01861301|Secondary|Incidence of Adverse Events, Graded Per NCI CTCAE Version 4|Grade 3 or higher AE of any type, regardless of attribution.|Up to 2 years|||percentage of participants||95% Confidence Interval|Number
660232|NCT01861301|Primary|Objective Radiologic Response Rate (Complete or Partial Response) Assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 1 year|Note: Study terminated for futility due to insufficient number of objective responders in first stage.||percentage of participants||95% Confidence Interval|Number
660233|NCT01860989|Primary|28-day Cure Rate|28-day cure rate was measured by the endpoint of complete cure without recrudescence before Day 29. The primary variable of 28-day cure rate was defined as the proportion of patients with clearance of asexual parasitemia (by blood film) by day 6 of the study, and without subsequent recrudescence (by blood film).|Day 28|PharmacoDynamic (PD) Analysis Set - All the 11 patients were included in PD analysis set.||Percentage of participants|||Number
660234|NCT01860976|Secondary|Percentage of Participants With at Least One Positive Immunogenicity Response up to Day 169 Relative to Baseline|Blood samples were collected at Days 1, 85 and 169 and assayed for the presence of abatacept-specific antibodies. The number of participants with at least one positive immunogenicity response was divided by the number of treated participants and expressed as a percentage.|Baseline to Day 169|All treated participants||Percentage of participants|||Number
663857|NCT01797029|Secondary|Percentage of Participants With Symptomatic, Laboratory-confirmed, Influenza Virus Infection (All Strains)||Through 7 to 9 months post-vaccination||||||
660235|NCT01860976|Secondary|Mean Change From Baseline in SF-36 Physical and Mental Components at Day 169|Adjusted mean change in scores on the Short Form 36 physical and mental function assessment (SF-36) from baseline were analyzed from the physical component summary (PCS) mental component summary (MCS). The SF-36 is a participant questionnaire assessing 8 domains of health status: physical functioning, pain, vitality, social functioning, psychological functioning, general health perception, and role limitations due to physical and emotional problems. The instrument can be divided into two summary scores, physical and mental component score. The scores range from 0 to 100, with a higher score indicating better quality of life. The two summary scores (PCS and MCS) will be calculated by taking a weighted linear combination of the 8 individual subscales.|Baseline to Day 169|All treated participants||units on a scale||Standard Error|Mean
660236|NCT01860976|Secondary|Percentage of ACR 50 and ACR 70 Responders at Day 169|The ACR 50 and ACR 70 definition of improvement is a 50% or 70% improvement, respectively, over baseline in tender and swollen joint counts and a 50% or 70% improvement in 3 of the 5 remaining core data set measures (participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, acute phase reactant value). The number of ACR 50 and ACR 70 responders was divided by the number of treated participants and expressed as a percentage. Early escape participants, and participants with missing data at day 169 were imputed as non-responders.|Day 169|All treated participants||Percentage of participants||95% Confidence Interval|Number
660237|NCT01860976|Secondary|Percentage of Participants Achieving a PASI 50 at Day 169 in Participants With Baseline BSA >= 3%|The number of participants who achieved at least 50% improvement from baseline in Psoriasis Area and Severity Index Arthritis (PASI 50) at Day 169 was divided by the number of treated participants with BSA >= 3% and expressed as a percentage. Only participants with >= 3% body surface area (BSA) of psoriatic skin involvement at randomization were included in this analysis.|Baseline to Day 169|All treated participants with >= 3% BSA of psoriatic skin involvement at randomization||Percentage of participants||95% Confidence Interval|Number
660238|NCT01860976|Secondary|Percentage of Non-progressors in Total PsA-modified SHS at Day 169|The number of radiographic non-progressors in total PsA-Modified Sharp van der Heijde score (SHS) at Day 169 was divided by the number of treated participants and expressed as a percentage. Non-progression was defined as a change from baseline in total PsA modified SHS ≤0. Early escape participants, and participants with missing data at day 169 were imputed as non-progressors.|Baseline to Day 169|All treated participants||Percentage of participants||95% Confidence Interval|Number
660239|NCT01860976|Secondary|Percentage of ACR 20 Responders at Day 169 in the TNFi-exposed Subpopulation|The ACR 20 definition of improvement is a 20% improvement over baseline in tender and swollen joint counts and a 20% in 3 of the 5 remaining core data set measures (participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, acute phase reactant value). The number of ACR 20 responders was divided by the number of treated, TNFi-exposed participants and expressed as a percentage. Early escape participants, and participants with missing data at day 169 were imputed as non-responders.|Day 169|All treated TNFi-exposed participants||Percentage of participants||95% Confidence Interval|Number
660240|NCT01860976|Secondary|Percentage of ACR 20 Responders at Day 169 in the TNFi-naïve Subpopulation|The ACR 20 definition of improvement is a 20% improvement over baseline in tender and swollen joint counts and a 20% in 3 of the 5 remaining core data set measures (participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, acute phase reactant value). The number of ACR 20 responders was divided by the number of treated, TNFi-naive participants and expressed as a percentage. Early escape participants, and participants with missing data at day 169 were imputed as non-responders.|Day 169|All treated TNFi-naïve participants||Percentage of participants||95% Confidence Interval|Number
660241|NCT01860976|Secondary|Percentage of Health Assessment Questionnaire (HAQ) Responders at Day 169|Participants were considered responders if their HAQ score decreased at least 0.35 from baseline. The number of HAQ responders was divided by the number of treated participants and expressed as a percentage. Scoring conventions are based on the Standard Disability Index of HAQ/HAQ-DI using the 20 response items. For each of the 8 disability categories there is an “aids/devices” companion variable that is used to record the type of assistance, if any, a participant uses for his/her usual activities. If either “aids/devices” and/or “assistance from another person” are checked for a disability category, the score for this category is set to “2” (much difficulty), if the original score was “0” (no difficulty) or “1” (some difficulty). The HAQ-DI is then calculated by summing the adjusted categories scores and dividing by the number of categories answered. Early escape participants, and participants with missing data at day 169 were imputed as non-responders.|Baseline to Day 169|All treated participants||percentage of participants||95% Confidence Interval|Number
660242|NCT01860976|Primary|Percentage of ACR 20 Responders at Day 169|The American College of Rheumatology (ACR) 20 definition of improvement is a 20% improvement over baseline in tender and swollen joint counts and a 20% improvement in 3 of the 5 remaining core data set measures (participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, acute phase reactant value). The number of ACR 20 responders was divided by the number of treated participants and expressed as a percentage. Early escape participants, and participants with missing data at day 169 were imputed as non-responders.|Day 169|All treated participants||Percentage of participants||95% Confidence Interval|Number
660243|NCT01860846|Secondary|Number of Participants With Serious Adverse Events|A serious adverse event was defined as any untoward medical occurrence in a clinical investigation participant that met at least 1 of the following criteria: death, life-threatening, hospitalization or prolongation of hospitalization, congenital anomaly, persistent or significant disability/incapacity, important medical event requiring medical or surgical intervention to prevent serious outcome, elective or spontaneous abortion.|From the time of informed consent until 30 days or 5 half-lives following the last dose, up to 62 weeks|All enrolled participants||Participants|||Count of Participants
660244|NCT01860846|Secondary|Change in Extra-intestinal Symptoms|Extra-intestinal manifestations of Crohn’s Disease (skeletal system [bones and muscle], dermatological [skin], hepatobiliary system [liver, gall bladder, and bile ducts], ocular [eyes] and oral [mouth]) were documented by the study investigators at each visit.|At baseline and 12 months|Participants with available data||Participants|||Count of Participants
660245|NCT01860846|Secondary|Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Scores|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a 32-item self-administered questionnaire to measure health-related quality of life in adults with Crohn’s Disease. The 32 items are grouped into subscales: bowel-related symptoms (10 items), systemic symptoms (5 items), social function (5 items), and emotional function (12 items). Responses to each item within each subscale range from 1 (significant impairment) to 7 (no impairment), and mean scores ranging from 1 to 7 are calculated for each subscale. Higher scores indicate a better quality of life.|At baseline and 12 months|Participants with available data||units on a scale||Standard Deviation|Mean
660246|NCT01860846|Secondary|Change in Short Form 36 (SF-36) Health Survey Scores|"The Short Form 36 (SF-36) Health Survey was used to determine participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Scores on each item were summed and averaged (range = 0 worst to 100 best). Increases from baseline indicate improvement."|At baseline and 12 months|Participants with available data||units on a scale||Standard Deviation|Mean
660247|NCT01860846|Primary|Total Activity Impairment (TAI)|The Work Productivity and Activity Impairment: General Health (WPAI:GH) questionnaire was used to assess impairments in both paid work and unpaid work due to symptoms of Crohn’s Disease. The self-administered questionnaire consisted of 6 questions. Question 6 asked participants to indicate the degree to which their health affected their regular activities in the past 7 days. Total activity impairment is the percent impairment of non-work related activities due to health problems and was calculated with the formula (Q6/10) × 100%. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.|At baseline and 12 months|Participants with available data||units on a scale||Standard Deviation|Mean
660248|NCT01860846|Primary|Total Work Productivity Impairment (TWPI)|The Work Productivity and Activity Impairment: General Health (WPAI:GH) self-administered questionnaire was used to assess impairments in work due to symptoms of Crohn’s Disease. Q2 asked participants the number of hours missed due to health problems in the past 7 days. Q4 asked participants the number of hours that they worked in the past 7 days. Q5 asked participants the degree to which their health affected productivity while working in the past 7 days, on a scale ranging from 0 (health problems had no effect) to 10 (health problems completely prevented them from working). Total work productivity impairment (TWPI) is the combined absenteeism and presenteeism for employed participants, the percentage of overall work productivity lost due to health problems. TWPI was calculated using the formula Q2/(Q2+Q4)+[(1-(Q2/(Q2+Q4)))×(Q5/10)] × 100%. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.|At baseline and 12 months|Participants with available data||units on a scale||Standard Deviation|Mean
660249|NCT01860846|Primary|Work Productivity and Activity Index (WPAI): Presenteeism|The Work Productivity and Activity Impairment: General Health (WPAI:GH) questionnaire was used to assess impairments in both paid work and unpaid work due to symptoms of Crohn’s Disease. The self-administered questionnaire consisted of 6 questions. Question 5 asked participants the degree to which their health affected productivity while working in the past 7 days, on a scale ranging from 0 to 10, with 0 indicating that health problems had no effect on their work and 10 indicating that health problems completely prevented the participant from working. Presenteeism (impairment at work) was calculated by the formula (Q5/10) × 100%. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.|At baseline and 12 months|Participants with available data||units on a scale||Standard Deviation|Mean
660250|NCT01860846|Primary|Work Productivity and Activity Index (WPAI): Absenteeism|The Work Productivity and Activity Impairment: General Health (WPAI:GH) questionnaire was used to assess impairments in both paid work and unpaid work due to symptoms of Crohn’s Disease. The self-administered questionnaire consisted of 6 questions. Question 2 asked participants to indicate the number of hours missed due to health problems in the past 7 days. Question 4 asked participants to indicate the number of hours that they worked in the past 7 days. Absenteeism (work time missed) was defined as the percentage of time absent from work due to health problems in the past week and was calculated by the formula Q2/(Q2 + Q4) × 100%. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.|At baseline and 12 months|Participants with available data||units on a scale||Standard Deviation|Mean
660251|NCT01860703|Secondary|Maximum Difference in Change From Baseline in ddQTcF Following a Single Dose of Moxifloxacin|"Change from baseline in QTcF interval was measured by looking at the post-dose difference in change from baseline in Fridericia's QT corrected heart rate (dQTcF) between treatment and placebo (ddQTcF) at each time interval.
ECG recordings were obtained within a 5-minute time window at Hours -0.75, -0.5, and -0.25 (prior to dosing) and Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose."|24-hour interval|Cardiodynamic Analysis Set : all randomized subjects who received at least 1 dose of study medication and who had valid Day 1 QT/QTc interval measurements (predose and at least one postdose measurement).||milliseconds||Standard Deviation|Least Squares Mean
660252|NCT01860703|Primary|Maximum Change From Baseline (dQT/dQTc)|"Maximum Change From Baseline (dQT/dQTc) for deferiprone and placebo.
ECG recordings were obtained within a 5-minute time window at Hours -0.75, -0.5, and -0.25 (prior to dosing) and Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose."|24-hour interval|The Cardiodynamic Analysis Set consisted of all randomized subjects who received at least 1 dose of study medication and who had valid Day 1 QT/QTc interval measurements (predose and at least one postdose measurement).||percentage of participants|||Number
660253|NCT01860703|Primary|Maximum Postdose QT/QTc Interval|"The maximum post-dose QT/QTc interval for deferiprone and placebo.
ECG recordings were obtained within a 5-minute time window at Hours -0.75, -0.5, and -0.25 (prior to dosing) and Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose."|24-hour interval|The Cardiodynamic Analysis Set consisted of all randomized subjects who received at least 1 dose of study medication and who had valid Day 1 QT/QTc interval measurements (predose and at least one postdose measurement).||percentage of participants|||Number
660869|NCT01851330|Secondary|Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set||percentage of participants|||Number
660254|NCT01860703|Primary|Maximum Difference in Change From Baseline in ddQTcF Following a Single Dose of 50 mg/kg Deferiprone|"Change from baseline in QTcF interval was measured by looking at the post-dose difference in change from baseline in Fridericia's QT corrected heart rate (dQTcF) between treatment and placebo (ddQTcF) at each time interval.
ECG recordings were obtained within a 5-minute time window at Hours -0.75, -0.5, and -0.25 (prior to dosing) and Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose."|24-hour interval|Cardiodynamic Analysis Set : all randomized subjects who received at least 1 dose of study medication and who had valid Day 1 QT/QTc interval measurements (predose and at least one postdose measurement).||milliseconds||Standard Deviation|Least Squares Mean
660255|NCT01860703|Secondary|T1/2 for Serum Deferiprone and Deferiprone 3-O-glucuronide|"T1/2 was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in healthy volunteers.
Serial blood samples were collected prior to dosing and within 5 minutes following completion of each scheduled post-dose ECG at Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose."|24-hour interval|The PK population consisted of all subjects who had taken study medication and had at least 1 PK sample collected.||hour||Standard Deviation|Mean
660256|NCT01860703|Secondary|AUC0-infinity for Serum Deferiprone and Deferiprone 3-O-glucuronide|"AUC0-infinity was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in healthy volunteers.
Serial blood samples were collected prior to dosing and within 5 minutes following completion of each scheduled post-dose ECG at Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose."|24-hour interval|The PK population consisted of all subjects who had taken study medication and had at least 1 PK sample collected.||μg *hr/mL||Standard Deviation|Mean
660257|NCT01860703|Secondary|Tmax of Deferiprone and Deferiprone 3-O-glucuronide|"To evaluate the Tmax of deferiprone and deferiprone 3-O-glucuronide following administration of single doses of 33 and 50 mg/kg deferiprone in healthy volunteers.
Serial blood samples were collected prior to dosing and within 5 minutes following completion of each scheduled post-dose ECG at Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose."|24-hour interval|The PK population consisted of all subjects who had taken study medication and had at least 1 PK sample collected.||hour||Full Range|Median
660258|NCT01860703|Secondary|Cmax of Deferiprone and Deferiprone 3-O Glucuronide|"To evaluate the Cmax of deferiprone and deferiprone 3-O-glucuronide following administration of single doses of 33 and 50 mg/kg deferiprone in healthy volunteers.
Serial blood samples were collected prior to dosing and within 5 minutes following completion of each scheduled post-dose ECG at Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose."|24-hour interval|The PK population consisted of all subjects who had taken study medication and had at least 1 PK sample collected.||μg/mL||Standard Deviation|Mean
660259|NCT01860703|Secondary|Number of Participants With Adverse Events|Number of participants with adverse events following therapeutic and supratherapeutic doses of deferiprone|From administration of the first dose until 7 days +/- 1 day following the final dose|The Safety Analysis Set consisted of all subjects who received at least 1 dose of study medication and had at least 1 safety assessment.||participants|||Number
660260|NCT01860703|Primary|Maximum Difference in Change From Baseline in ddQTcF Following a Single Dose of 33 mg/kg Deferiprone|"Change from baseline in QTcF interval was measured by looking at the post-dose difference in change from baseline in Fridericia's QT corrected heart rate (dQTcF) between treatment and placebo (ddQTcF) at each time interval.
ECG recordings were obtained within a 5-minute time window at Hours -0.75, -0.5, and -0.25 (prior to dosing) and Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose."|24-hour interval|Cardiodynamic Analysis Set : all randomized subjects who received at least 1 dose of study medication and who had valid Day 1 QT/QTc interval measurements (predose and at least one postdose measurement).||milliseconds||Standard Deviation|Least Squares Mean
660261|NCT01860677|Secondary|Change in Visual Analogue Scale (VAS) in Active Stimulation Arm|"Visual Analogue Scale (VAS) ranges from 0-100. Anchors of “not at all” (0) to “most ever” (100) were used to rank the following:
anxious, sleepy, dizzy, relaxed, physical symptoms, confused, sluggish, energetic, fatigued, and stressed. Change compares post-treatment to pre-treatment."|within 30 minutes after 1-day CES treatment concluded; pre-treatment is at least 20 minutes before end of treatment|"Data were not collected for Sham intervention; Outcome pre-specified to be assessed for Active Arm only.
3 participants were missing data on these measures."||units on a scale||Standard Deviation|Mean
660262|NCT01860677|Secondary|Change in Positive and Negative Affect Schedule (PANAS) in Active Stimulation Arm|"Positive and Negative Affect Schedule (PANAS), as defined by Watson et al. (1988), range between 10 and 50 points. Anchors of not at all (10) to most ever (50) were used to rank each measure. Change compares post-treatment to pre-treatment.
Positive Affects included the following terms: Attentive, Active, Alert, Excited, Enthusiastic, Determined, Inspired, Proud, Interested, and Strong. Negative Affects included the following terms: Hostile, Irritable, Ashamed, Guilty, Distressed, Upset, Scared, Afraid, Jittery, and Nervous. Higher positive affect scores indicated a better outcome, while lower negative affect scores indicated a better outcome."|within 30 minutes after CES treatment concluded; pre-treatment is at least 20 minutes before end of treatment|Participants in the active stimulation arm. Data were not collected for Sham intervention; Outcome pre-specified to be assessed for Active Arm only.||units on a scale||Standard Deviation|Mean
660263|NCT01860677|Secondary|BOLD fMRI (Neural Activation Patterns/Brain Function) in Active Stimulation Arm Only|"Quantitative changes in neural activation patterns during task performance as measured by BOLD functional MRI from 20 minutes of CES compared to pre-treatment.
The coupling ratio is defined as the percent change in the cerebral blood flow divided by the percent change in the cerebral metabolic rate of oxygen consumption."|within 30 minutes after CES treatment concluded; pre-treatment is at least 20 minutes before end of treatment|Data were not collected for Sham intervention; Outcome pre-specified to be assessed for Active Arm only||coupling ratio||Standard Deviation|Mean
660264|NCT01860677|Primary|BOLD fMRI (Neural Activation Patterns/Brain Function) Among Participants Who Completed Both Active and Sham Stimulation Visits|"Quantitative changes in neural activation patterns during task performance as measured by BOLD functional MRI from 20 minutes of CES compared to pre-treatment.
The coupling ratio is defined as the percent change in the cerebral blood flow divided by the percent change in the cerebral metabolic rate of oxygen consumption."|within 30 minutes after CES treatment concluded; pre-treatment is at least 20 minutes before end of treatment|Data were not collected|||||
663858|NCT01797029|Secondary|Safety Profile of LAIV: Protocol Defined Wheezing Illness||Through 7 to 9 months post-vaccination||||||
660266|NCT01860586|Secondary|The Effect of Intravitreal Bevacizumab Injections on the Development of Epiretinal Membranes (Increase or Decrease)|To determine if intravitreal bevacizumab injections will increase or decrease the occurences (cases) of epiretinal membranes .|6 months|Number of patients treated with bevacizumab who developed epiretinal membrane||Participants|||Count of Participants
660267|NCT01860586|Primary|The Effect of Intravitreal Bevacizumab Injections on Rate of Recurrent Retinal Detachment (Increase or Decrease)|This will be assessed by the frequency (occurences) of retinal detachments in patients that have intravitreal bevacizumab injections versus prior patients that did not have intravitreal bevacizumab injections.|up to 6 months|Bevacizumab treated patients with recurrent retinal detachment||Participants|||Count of Participants
660268|NCT01860573|Secondary|Serum Blood Urea Nitrogen||Day of life 1, 2, 3, 5 and 7|||mg/dL||Standard Deviation|Mean
660269|NCT01860573|Secondary|Serum Creatinine||Day of life 1, 2, 3, 5 and 7|||mg/dL||Standard Deviation|Mean
660270|NCT01860573|Secondary|Serum Bicarbonate||Day of life 1, 2, 3, 5 and 7|||mmol/L||Standard Deviation|Mean
660271|NCT01860573|Primary|Cognitive Development Score|Reported as units on a scale with mean of 100 and a Standard Deviation of 15, and range from 40–160. Higher values indicate a better outcome.|18-22 months corrected gestational age|Data not available for subjects who died or were lost to follow up.||units on a scale||Standard Deviation|Mean
660272|NCT01860573|Primary|Number of Participants With Head Circumference <10th Percentile for Age||36 weeks post-conceptual age|Data not available for subjects who died or were discharged prior to 36 weeks post-conceptual age and some data were missing.||Participants|||Count of Participants
660273|NCT01860573|Primary|Number of Participants With Length <10th Percentile for Age||36 weeks post-conceptual age|Data not available for subjects who died or were discharged prior to 36 weeks post-conceptual age, and some data were missing.||Participants|||Count of Participants
660274|NCT01860573|Primary|Number of Participants With Weight<10th Percentile for Age||36 weeks post-conceptual age|Data not available for subjects who died or were discharged prior to 36 weeks post-conceptual age||Participants|||Count of Participants
660275|NCT01860534|Secondary|Pain|At 3 times (pre-mydriasis, 1 hour and 3 hours after Cyclomydril drops), subjects were exposed to ambient lighting for a period of five minutes. This usually entailed removing isolette covers and exposing the patient to the ambient room light. During this time, pain and vital signs were recorded every minute. Pain scores were recorded by direct observation using the Neonatal and Infant Pain Scale (NIPS). The mean of the five recorded values for each variable was used. NIPS scoring consists of 6 measures associated with neonatal or infant pain, each with a range of 0-7 with low scores (0-2) associated with no pain and scores > to 4 associated with severe pain. Maximum scoring would be 42 for severe pain and minimal being 0 for no pain. The six measures on NIPS include: facial expression, crying, breathing patterns, arm movements, leg movements and state of arousal.|pre-mydriasis, 1 hour and 3 hours after mydriatic drops|||units on a scale||Standard Deviation|Mean
660276|NCT01860534|Secondary|Oxygen Percent Saturation|At 3 times (pre-mydriasis, 1 hour and 3 hours after Cyclomydril drops), subjects were exposed to ambient lighting for a period of five minutes. This usually entailed removing isolette covers and exposing the patient to the ambient room light. During this time, pain and vital signs were recorded every minute. Oxygen percent saturation was recorded directly from their cardio-respiratory monitor (Agilent M1106C). The mean of the five recorded values for each variable was used|pre-mydriasis, 1 hour and 3 hours after mydriatic drops|||percent saturation||Standard Deviation|Mean
660277|NCT01860534|Secondary|Respiratory Rate|At 3 times (pre-mydriasis, 1 hour and 3 hours after Cyclomydril drops), subjects were exposed to ambient lighting for a period of five minutes. This usually entailed removing isolette covers and exposing the patient to the ambient room light. During this time, pain and vital signs were recorded every minute. Respiratory rate was recorded directly from their cardio-respiratory monitor (Agilent M1106C). The mean of the five recorded values for each variable was used|pre-mydriasis, 1 hour and 3 hours after mydriatic drops|||Breaths per minutes||Standard Deviation|Mean
660278|NCT01860534|Primary|Heart Rate|At 3 times (pre-mydriasis, 1 hour and 3 hours after Cyclomydril drops), subjects were exposed to ambient lighting for a period of five minutes. This usually entailed removing isolette covers and exposing the patient to the ambient room light. During this time, pain and vital signs were recorded every minute. Heart rate was recorded directly from their cardio-respiratory monitor (Agilent M1106C). The mean of the five recorded values for each variable was used|pre-mydriasis, 1 hour and 3 hours after mydriatic drops|||Beats per minutes||Standard Deviation|Mean
660279|NCT01860521|Secondary|Total Sufentanil Consumption.||During the whole analgesia procedure (assessed between the starting of the procedure until 66 hours).|||microg||Standard Deviation|Mean
660280|NCT01860521|Secondary|Total Levobupivacaine Consumption||At the moment of fetal expulsion (up to 66 hours from starting of the procedure).|||mg||Standard Deviation|Mean
660281|NCT01860521|Secondary|Degree of Satisfaction of the Patients With the Analgesia Procedure|At discharge from the hospital, patients were requested to answer the following question “Taking into consideration the variations in pain symptoms, as well as the adverse events experienced, if any, how would you define the grade of satisfaction with your analgesic treatment?” The grade of satisfaction was assessed using a visual analog scale (VAS) where 0 corresponded to “completely unsatisfied” and 100 to “completely satisfied”.|At discharge from the hospital (up to 72 hours from starting of the procedure).|||mm||Standard Deviation|Mean
660282|NCT01860521|Primary|Incidence of Motor Block|The assessment of the degree of motor block was performed in the right and left lower extremities using the Breen modified Bromage score: 1 = complete block (unable to move feet or knees), 2 = almost complete block (able to move feet only), 3 = partial block (just able to move knees), 4 = detectable weakness of hip flexion while supine (between scores 3 and 5), 5 = no detectable weakness of hip flexion while supine (full flexion of knees), and 6 = able to stand and to perform partial knee bend. Patients with a Bromage score < 6 were considered to have motor block.|Assessed every hour from starting the analgesia procedure (up to 66 hours from starting of the procedure).|||participants|||Number
660409|NCT01857531|Secondary|Percentage of Change in Expired Air Carbon Monoxide (CO) at End of Week 4|To evaluate the effects of ganaxolone as an augmentation treatment in conjunction with nicotine patch by looking at the percent change in expired air CO at the end of week four (relative to baseline).|Baseline and 4 Weeks|Three of the original 16 subjects dropped out prior to week 4, so only 13 subjects had a week 4 CO reading and could be included in this analysis.||percentage change||Standard Error|Mean
660283|NCT01860170|Other Pre-specified|GVHD|"aGVHD onset at a certain grade will be used to calculate the cumulative incidence for that grade (e.g., onset of grade 70 post-transplant , time to grade III is 70 days). This end point will be evaluated through day 150 post-transplant. The diagnosis of aGVHD is based on clinical and pathological evaluation by the treating physician.
The first day of cGVHD will be used to calculate the cumulative incidence of cGVHD. The diagnosis of cGVHD is based on clinical and pathological evaluation by the treating physician."|Assessed routinely by clinical and pathological evaluation. Acute GVHD will be assessed up to day 150 post-transplant. Chronic GVHD will be assess up to 2 years post-transplant.|||participants|||Number
660284|NCT01860170|Secondary|Engraftment|"Neutrophil engraftment is defined as achieving an absolute neutrophil count (ANC) > 0.5 109/L for 3 consecutive measurements on different days. The first of the 3 days will be considered the day of neutrophil engraftment.
Platelet engraftment is defined as platelet count > 20 109/L for 3 consecutive measurements over at least 3 days. The first of the 3 days will be considered the day of platelet engraftment.
In this study, graft failure is defined as lack of achieving neutrophil engraftment by day 22 and donor chimerism > 50% by day 45."|Assessed daily by laboratory evaluation until engraftment or up to 90 days.|||Participants|||Count of Participants
660285|NCT01860170|Primary|Dose Limiting Toxicity|Grade 3 non-hematologic Common Toxicity Criteria toxicity directly related to bortezomib (such as peripheral neuropathy) or Grade 2 or > hepatic bilirubin Common Toxicity Criteria Graft failure|Assessed daily (while inpatient) through clinical and laboratory examination up to 90 days.|||Participants|||Count of Participants
660286|NCT01860079|Primary|All Cause Mortality and Readmission at 30 Days.|The primary end points were all cause mortality by 1 month and readmission due to reinfarction, unstable angina, arrhythmia, congestive heart failure, revascularization, stroke or major bleeding at 1 month.|30 DAYS|||participants|||Number
660287|NCT01859988|Secondary|Changes in GISS Cumulative Score From Baseline to Week 16|Individual components of the AD lesions (erythema, infiltration/papulation, excoriations, and lichenification) were rated globally (each assessed for the whole body, not by anatomical region) on a 4-point scale (0 = none,1 = mild, 2 = moderate and 3 = severe) using the EASI severity grading criteria. Total score ranges from 0 (absent disease) to 12 (severe disease).|Baseline to Week 16|Analysis was performed on FAS. Here, number of participants analyzed = participants with GISS score assessment at specified time-points. Missing values imputed by LOCF.||units on a scale||Standard Error|Least Squares Mean
660288|NCT01859988|Secondary|Changes in Global Individual Signs Score (GISS) Components (Erythema, Infiltration/Papulation, Excoriations, and Lichenification) From Baseline to Week 16|Individual components of the AD lesions (erythema, infiltration/papulation, excoriations, and lichenification) were rated globally (each assessed for the whole body, not by anatomical region) on a 4-point scale (0=none, 1=mild, 2=moderate and 3=severe) using the EASI severity grading criteria. Total score ranges from 0 (absent disease) to 12 (severe disease).|Baseline to Week 16|Analysis was performed on FAS. Here, number of participants analyzed = participants with GISS score assessment at specified time-points. Missing values imputed by LOCF.||units on a scale||Standard Error|Least Squares Mean
660289|NCT01859988|Secondary|Absolute Change in POEM Scores From Baseline to Week 16|POEM is a 7-item questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease) (high score indicative of poor quality of life [QOL]).|Baseline to Week 16|Analysis was performed on FAS. Here, number of participants analyzed = participants with POEM score assessment at specified time-points. Missing values imputed by LOCF.||units on a scale||Standard Error|Least Squares Mean
660290|NCT01859988|Secondary|Percent Change in Patient Oriented Eczema Measure (POEM) Scores From Baseline to Week 16|POEM is a 7-item questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease) (high score indicative of poor quality of life [QOL]).|Baseline to Week 16|Analysis was performed on FAS. Here, number of participants analyzed = participants with POEM score assessment at specified time-points. Missing values imputed by LOCF.||Percent change||Standard Error|Least Squares Mean
660291|NCT01859988|Secondary|Percentage of Participants Who Achieved 50%, 75% and 90% Reduction From Baseline in SCORAD Score (SCORAD-50, SCORAD-75 and SCORAD-90 Respectively) at Week 16|SCORAD is a clinical tool for assessing the severity of AD developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index). Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology (Basel) 186 (1): 23–31. 1993. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease). SCORAD-50, SCORAD-75 and SCORAD-90 responders were the participants who achieved ≥50%, ≥75% and ≥90% overall improvement in SCORAD score respectively from baseline to Week 16.|Week 16|Analysis was performed on FAS. Participants with a missing SCORAD score at Week 16 were treated as non-responders.||Percentage of participants||95% Confidence Interval|Number
660292|NCT01859988|Secondary|Percentage of Participants Who Achieved 50%, 75% and 90% Reduction From Baseline in EASI Score (EASI-50, EASI-75 and EASI-90 Respectively) at Week 16|The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-50, EASI-75 and EASI-90 responders were the participants who achieved ≥50%, ≥75% and ≥90% overall improvement in EASI score respectively from baseline to Week 16.|Week 16|Analysis was performed on FAS. Participants with a missing EASI score at Week 16 were treated as non-responders.||Percentage of participants||95% Confidence Interval|Number
660293|NCT01859988|Secondary|Absolute Change in SCORAD Scores From Baseline to Week 16|SCORAD is a clinical tool for assessing the severity of AD developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index). Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology (Basel) 186 (1): 23–31. 1993. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease).|Baseline to Week 16|Analysis was performed on FAS. Here, number of participants analyzed = participants with SCORAD score assessment at specified time-points. Missing values imputed by LOCF.||units on a scale||Standard Error|Least Squares Mean
663859|NCT01797029|Secondary|Safety Profile of LAIV: Serious Adverse Events||Through 7 to 9 months post-vaccination||||||
660294|NCT01859988|Secondary|Percent Change in SCORing Atopic Dermatitis (SCORAD) Scores From Baseline to Week 16|SCORAD is a clinical tool for assessing the severity of AD developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index). Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology (Basel) 186 (1): 23–31. 1993. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease).|Baseline to Week 16|Analysis was performed on FAS. Here, number of participants analyzed = participants with SCORAD score assessment at specified time-points. Missing values imputed by LOCF.||Percent change||Standard Error|Least Squares Mean
660295|NCT01859988|Secondary|Absolute Change in EASI Score From Baseline to Week 16|The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.|Baseline to Week 16|Analysis was performed on FAS. Here, number of participants analyzed = participants with EASI score assessment at specified time-points. Efficacy data was set to missing after use of rescue medication. Missing values imputed by LOCF.||Units on a scale||Standard Error|Least Squares Mean
660296|NCT01859988|Secondary|Absolute Change in Peak Weekly Averaged Pruritus NRS From Baseline to Week 16|Pruritus NRS is an assessment tool that is used to report the intensity of participant’s pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 – 10 [0 = no itch; 10 = worst itch imaginable]).|Baseline to Week 16|Analysis was performed on FAS. Here, number of participants analyzed =participants with pruritus NRS assessment at specified time-points. Efficacy data was set to missing after use of rescue medication. Missing values imputed by LOCF.||units on a scale||Standard Deviation|Mean
660297|NCT01859988|Secondary|Percent Change in Peak Weekly Averaged Pruritus Numerical Rating Scores (NRS) From Baseline to Week 16|Pruritus NRS is an assessment tool that is used to report the intensity of participant’s pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 – 10 [0 = no itch; 10 = worst itch imaginable]).|Baseline to Week 16|Analysis was performed on FAS. Here, number of participants analyzed = participants with pruritus NRS assessment at specified time-point. Efficacy data was set to missing after use of rescue medication. Missing values imputed by LOCF.||Percent change||Standard Deviation|Mean
660298|NCT01859988|Secondary|Percentage of Participants Who Achieved IGA Score Reduction of ≥2 at Week 16|IGA is an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic success is an IGA score of 0 (clear) or 1 (almost clear). Participants with IGA score reduction from baseline of ≥2 points at Week 16 were reported. Values after first rescue medication were set to missing and participants with missing IGA score at Week 16 were treated as a non-responders.|Week 16|Analysis was performed on FAS.||Percentage of participants||95% Confidence Interval|Number
660299|NCT01859988|Secondary|Percentage of Participants Who Achieved Investigator's Global Assessment (IGA) Response at Week 16|IGA is an assessment scale used to determine severity of AD and clinical response to treatment on a static 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response is an IGA score of 0 (clear) or 1 (almost clear). Values after first rescue medication were set to missing and participants with missing IGA score at Week 16 were treated as a non-responders.|Week 16|Analysis was performed on FAS.||Percentage of participants||95% Confidence Interval|Number
660300|NCT01859988|Primary|Percent Change in Eczema Area and Severity Index Score (EASI) From Baseline to Week 16|The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.|Baseline to Week 16|Full analysis set (FAS) that included all randomized participants who received at least 1 dose of study drug. Here, number of participants analyzed = participants with EASI score assessment at specified time-point. Efficacy data was set to missing after use of rescue medication. Missing values imputed by last observation carried forward (LOCF).||Percent change||Standard Deviation|Least Squares Mean
660301|NCT01859949|Secondary|Height SDS for Bone Age|"To measure bone age, X-ray images of the left hand were centrally assessed by an independent specialist using the Tanner-Whitehouse 2 (RUS) method standardized for Japanese children.
Height SDS for bone age is calculated as following formula; Height SDS = (height - mean) / standard deviation,
where mean and standard deviation were based on standard Japanese values corresponding to bone age and gender.
The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender."|Month 12 (at the end of previous study) to 156|Full Analysis Set (FAS) included participants who received at least 1 dose of study medication and had at least one observation after enrollment of this study.||SDS||Standard Deviation|Mean
660302|NCT01859949|Secondary|Height Velocity SDS for Bone Age|"To measure bone age, X-ray images of the left hand were centrally assessed by an independent specialist using the Tanner-Whitehouse 2 (RUS) method standardized for Japanese children.
Height velocity is the yearly height gain. Height velocity SDS for bone age is calculated as following formula; Height velocity SDS = (height velocity - mean) / standard deviation,
where mean and standard deviation were based on standard Japanese values corresponding to bone age and gender.
The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender."|Month 12 (at the end of previous study) to 156|Full Analysis Set (FAS) included participants who received at least 1 dose of study medication and had at least one observation after enrollment of this study.||SDS||Standard Deviation|Mean
660410|NCT01857531|Primary|Percentage of Change in Expired Air Carbon Monoxide (CO) at End of Week 2|To evaluate the effects of ganaxolone on ad lib smoking by looking at the percent change in expired air CO at the end of week two (relative to baseline).|Baseline and 2 Weeks|||percentage change||Standard Error|Mean
663860|NCT01797029|Secondary|Safety Profile of LAIV: Immediate Reactions||30 minutes post-vaccination|||participants|||Number
660303|NCT01859949|Secondary|Height SDS for Chronological Age|"Height SDS is calculated as following formula; Height SDS = (height - mean) / standard deviation,
where mean and standard deviation were based on standard Japanese values on the participant age and gender.
The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender."|Month 12 (at the end of previous study) to 156|Full Analysis Set (FAS) included participants who received at least 1 dose of study medication and had at least one observation after enrollment of this study.||SDS||Standard Deviation|Mean
660304|NCT01859949|Secondary|Height Velocity|Height velocity is the yearly height gain|Month 12 (at the end of previous study) to 156|Full Analysis Set (FAS) included participants who received at least 1 dose of study medication and had at least one observation after enrollment of this study.||cm/year||Standard Deviation|Mean
660305|NCT01859949|Secondary|Height Velocity Standard Deviation Score (SDS) for Chronological Age|"Height velocity is the yearly height gain. Height velocity SDS is calculated as following formula; Height velocity SDS = (height velocity - mean) / standard deviation,
where mean and standard deviation were based on standard Japanese values of the participants age and gender.
The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender."|Month 12 (at the end of previous study) to 156|Full Analysis Set (FAS) included participants who received at least 1 dose of study medication and had at least one observation after enrollment of this study.||SDS||Standard Deviation|Mean
660306|NCT01859949|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)||Month 12 (at the end of previous study) to 156|Full Analysis Set (FAS) included participants who received at least 1 dose of study medication and had at least one observation after enrollment of this study.||participant|||Number
660307|NCT01859793|Secondary|Circulating Inflammatory Markers VCAM-1||Change before and after acute dose (2 hours) and 8 weeks after daily dosing of medication|29 of the 30 subject who completed the study. Once subject had missing data for the post-8 weeks of each intervention||mg/mL||Standard Deviation|Mean
660308|NCT01859793|Secondary|Circulating Inflammatory Marker ICAM-1||Change before and after acute dose (2 hours) and 8 weeks after daily dosing of medication|29 of the 30 subjects who completed both arms of the study. One subject was missing the measurements post 8 weeks of each intervention arm and was excluded||mg/mL||Standard Deviation|Mean
660309|NCT01859793|Primary|Brachial Artery Flow Mediated Dilation|A measurement of endothelial function in humans|Change before and after a single dose (2 hours post) and 8 weeks after daily dosing|All 30 subjects who completed both arms of the cross-over study||%FMD||Standard Deviation|Mean
660310|NCT01859715|Secondary|Adverse Drug Events|Determine all possible adverse drug events that occurred after the study drugs were administered.|Duration of ED stay, <24 hours. (up to 24 hours)|||participants|||Number
660311|NCT01859715|Primary|Difference in Clinically Significant Visual Analogue Scale for Pain and Nausea Change Between CYP2D6 Users and Non-users|Clinically significant visual analogue scale (VAS; a measure of adult pain and nausea on a scale of 1-100 millimeters for increasing symptoms of pain and nausea) for patients who were administered either oxycodone, hydrocodone/acetaminophen, or ondansetron in the ED. Clinically significant change was defined as 13mm change on the VAS from baseline (when first VAS was completed) to 90 minutes following drug administration in the ED.|Baseline and 90 minutes|||millimeters||95% Confidence Interval|Mean
660312|NCT01859702|Primary|Mean Aqueous Humor Concentration of Moxifloxacin|A 0.150 milliliter sample of the aqueous humor was obtained during cataract surgery. The concentration of moxifloxacin was measured by a validated procedure using high performance liquid-spectrometry.|Day 3 (operative day)|Per protocol: All subjects who met inclusion/exclusion criteria, received all doses of the test product, and underwent cataract surgery with aqueous humor sampling.||nanograms per milliliter||95% Confidence Interval|Mean
660313|NCT01859637|Secondary|Change in Absolute Neutrophile Count (ANC)|"To evaluate the efficacy of Zarzio®/Filgrastim HEXAL® in patients with SCN in terms of changes in absolute neutrophile count (ANC).
Change from each visit to baseline in ANC for all patients is calculated."|Participants were followed for a duration of 12 months and ANC was assessed at baseline, week 6, Month 3, Month 6, Month 9 and Month 12.|Safety population (SAF): all patients with at least one dose Zarzio®/Filgrastim HEXAL® and at least one post-baseline safety assessment||10^9 cells/L||Full Range|Median
660314|NCT01859637|Secondary|Number of Participants With Adverse Events (AEs)|Patients experiencing AEs by system organ class and preferred term (PT) and number of events. Patients with more than one AE coded to the same PT were counted once per PT|12 months|Safety population (SAF): all patients with at least one dose Zarzio®/Filgrastim HEXAL® and at least one post-baseline safety assessment||participants|||Number
660315|NCT01859637|Primary|Incidence of Anti- Recombinant Human Granulocyte Colony Stimulating Factor (rhG-CSF) Antibodies|"Incidence of anti-rhG-CSF antibodies was monitored. Patients were screened for anti-rhG-CSF antibodies at screening and at each study except visit 02 (start of treatment = baseline).
Evaluation of immune response to rhG-CSF administration was made by a three-step procedure comprising a validated binding antibody screening and confirmatory radioimmunoprecipitation assay (RIP) and a validated cell-based neutralization antibody assay (NAB)."|screening, 3, 6, 9 and 12 months|Safety population (SAF): All patients with at least one dose Zarzio®/Filgrastim HEXAL® and at least one post-baseline safety assessment. All six patients were screened for anti-rhG-CSF antibodies at all six study visits, except for one missing assessment (no sample was taken for patient 0204 at Visit 03, which was an optional visit).||participants|||Number
660316|NCT01859611|Secondary|Adverse Events.|At every treatment and follow-up visit the treated areas will be examined to evaluate side effects and adverse reactions remaining from the previous treatment session or occurring since then.|Subjects will be followed for the duration of the study, and expected average of 20 weeks||||||
660317|NCT01859611|Secondary|Patient Satisfaction and Comfort of the Treatment.|At each of the specified time points, subjects will complete a Subject Evaluation Form assessing their opinion of improvement and overall satisfaction with treatment.|Pre Treatment 5, 1 Week FU, 1 Month FU, 3 Month FU||||||
660387|NCT01857882|Secondary|Satisfaction With Information (Sub-scale of BREAST-Q)|"The BREAST-Q is a procedure-specific and validated PRO that measures Hr-QOL and patient satisfaction with breast reconstruction. The Satisfaction with Information Subscale specifically measures patient satisfaction with the preoperative information and care provided by the plastic surgeon and other members of the medical team. There are 15 items that use a four-level Likert scale response format, the score is transformed on a scale of 0 to 100 with higher scores indicating greater satisfaction."|T1 (1 week after surgical consultation)||||||
660318|NCT01859611|Primary|Changes to the Surface by Visual and Photographic Analysis.|"At each of the specified time points, photographs of the treated areas will be taken. The photography angles will include a global frontal photo and the right and left sides of the face at 45° and/or 90°. In addition, close up photos will be taken of specific facial zones, e.g., the peri-orbital wrinkles.
Each patient to be evaluated through the 9 grade Fitzpatrick Wrinkling Severity Scale.
Wrinkling Score Degree of Elastosis Fine 1-3 Mild Fine to moderate 4-6 Moderate Fine to deep wrinkles 7-9 Severe"|3 Month FU|Number of participants with observed changes (grade of improvement ≥ 1) to the surface of the skin based on photographic analysis at 3 Month FU||participants|||Number
660319|NCT01859598|Secondary|Overall Weight Gain From Visit 1 to Visit 3|the weight gain= the mean weight at visit1 - the mean weight at visit 3|baseline and 6 months|Patients at visit 3 were used for analyzing the change of weight||Kg||Standard Deviation|Mean
660320|NCT01859598|Secondary|the FPG Control Rate at Visit 3|the percentage of patients who had the FPG level <7.0 mmol/L at visit 3|6 months|At visit 3, the patients who self-reported their FPG level were used for analysis||percentage of patients with FPG<7.0|||Number
660321|NCT01859598|Secondary|the FPG Change From Visit 1 to Visit 3|the FPG change = the FPG level at visit 1- the FPG level at visit 3|baseline and 6 months|the population in the visit 3 were used for analysis||mmol/L||Standard Deviation|Mean
660322|NCT01859598|Primary|the Change of Hypoglycemia During Follow-up.|•The rate of hypoglycemia at baseline, 3 months (visit 2) and 6 months (visit 3)|baseline and 6 months|The population at visit 3 were used to analyze the hypoglycemia and weight change from visit 1 to visit 3||percentage of patients with hypoglycemia|||Number
660323|NCT01859598|Primary|To Assess the Change in HbA1c During the 6 Months Follow-up.|• Change of HbA1c from baseline to the end-point (6 month).|Baseline and 6 months|the patients who have the results of HbA1c||percent||Standard Deviation|Mean
660324|NCT01859507|Secondary|Successful Sexual Relationship|The level of comfort by the couple. The secondary outcome will be assessed by the couple. The couple is allowed to visit for follow up every three months for twelve months. Our inquiry is on the success of full and repeated penetration of the penis through the vaginal introitus into the vagina without or with acceptable pain. An acceptable outcome will be at least twice weekly successful sexual relationship that was completedwithout premature interruption from either partners.|Within twelve months after the Botox injection|||participants|||Number
660325|NCT01859507|Primary|Success of Repeated Penetration of the Penis Through the Vaginal Introitus Into the Vagina Without or With Acceptable Pain|The primary outcome will be assessed by the couple. The couple is allowed to visit for follow up in a 4 weeks' time. Our inquiry is on the success of full and repeated penetration of the penis through the vaginal introitus into the vagina without or with acceptable pain. An acceptable outcome will be at least twice weekly successful sexual relationship that was completed without premature interruption from either partners.|Up to four weeks following the last session of the vaginal dilatation.|multiple penetration with minimal pain as informed by the couple during their follow up sessions 4 weeks after the completion of the dilatation sessions||participants|||Number
660326|NCT01859494|Secondary|Number of Subject Responses That 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements|Staff obtained subject responses using short questionnaires to provide feedback on instructions for use and the basic operation of the BGMS. Subjects could respond 'Strongly Agree' 'Agree' 'Neutral' 'Disagree' or 'Strongly Disagree'.|1 hour|218 (219-1) responses were analyzed. One subject discontinued from testing after low BG result (hypoglycemia Adverse Event).||Participant Responses|||Number
660327|NCT01859494|Secondary|Number of Subject Fingerstick BG Results Within +/- 15mg/dL (<75mg/L YSI) or Within +/- 20% (>=75mg/dL YSI) of Laboratory Glucose Method When Tested by Study Staff|Study staff tested subject fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma results were used to calculate the number of BGMS results within +/- 15mg/dL (<75mg/dL YSI capillary plasma) or +/- 20% (>=75mg/dL YSI capillary plasma)|1 hour|218 (219-1) Blood glucose results were analyzed. One subject discontinued from testing after low BG result (hypoglycemia AE), thus no reference result available for that subject.||Blood Glucose results within 15mg/dL/20%|||Number
660328|NCT01859494|Secondary|Number of Glucose Results From Alternative Site Testing (AST) of the Palm Within +/- 15mg/dL (<75mg/L YSI) or Within +/- 20% (>=75mg/dL YSI) of Laboratory Glucose Method|Untrained subjects with diabetes self-tested Alternative Site (AST) palm blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS AST results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma BG results were used to calculate the number of AST BGMS results within +/- 15mg/dL (<75mg/dL YSI capillary plasma) or +/- 20% (>=75mg/dL YSI capillary plasma)|1 hour|211 (219-8) Blood glucose results were analyzed. One subject discontinued from all testing after hypoglycemia Adverse Event. Three subjects with low blood sugar did not attempt palm testing per protocol. Two subjects had low blood sugar; their palm results were not evaluable per protocol. Two subjects failed to obtain palm blood for testing.||Blood Glucose results within 15mg/dL/20%|||Number
660329|NCT01859494|Secondary|Number of Self-Test Fingerstick Blood Glucose (BG)Results Within +/- 12.5mg/dL (<100mg/L YSI) or Within +/- 12.5% (>=100mg/dL YSI) of Laboratory Glucose Method|Untrained subjects with diabetes self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI BG results were used to calculate the number of BGMS results within +/- 12.5mg/dL (<100mg/dL YSI capillary plasma) or +/- 12.5% (>=100mg/dL YSI capillary plasma)|1 hour|218 (219-1) Blood glucose results were analyzed. One subject discontinued from testing after low BG fingerstick result (hypoglycemia AE), thus no reference result available for that subject.||Bld Glucose results w/in 12.5mg/dL/12.5%|||Number
660330|NCT01859494|Secondary|Number of Self-Test Fingerstick Blood Glucose (BG)Results Within +/- 15mg/dL (<100mg/L YSI) or Within +/- 15% (>=100mg/dL YSI) of Laboratory Glucose Method|Untrained subjects with diabetes self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI BG results were used to calculate the number of BGMS results within +/- 15mg/dL (<100mg/dL YSI capillary plasma) or +/- 15% (>=100mg/dL YSI capillary plasma)|1 hour|218 (219-1) Blood glucose results were analyzed. One subject discontinued from testing after low BG fingerstick result (hypoglycemia AE), thus no reference result available for that subject.||Blood Glucose results within 15mg/dL/15%|||Number
660331|NCT01859494|Primary|Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/-15mg/dL (<75mg/dL) or Within +/-20% (>=75mg/dL) of Laboratory Glucose Method|Untrained subjects with diabetes self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the number of BGMS results within +/- 15mg/dL (<75mg/dL YSI capillary plasma) or +/- 20% (>=75mg/dL YSI capillary plasma).|1 hour|218 (219-1) Blood glucose results were analyzed. One subject discontinued from testing after low Blood Glucose (BG) fingerstick result (hypoglycemia AE), thus no reference result available for that subject.||Blood Glucose results within 15mg/dL/20%|||Number
660332|NCT01859390|Secondary|Number of Participants Hospitalized|Number (%) of participants with at least one hospitalization between Baseline (Visit 2) and end of follow up (Week 18).|Baseline (Visit 2) to end of followup (Week 18)|||Participants|||Count of Participants
660333|NCT01859390|Secondary|Number of Participants With Pulmonary Exacerbations|Number (%) with at least one protocol-defined PEx between baseline (Visit 2) and end of follow up (Week 18).|Baseline (Visit 2) to end of follow up (Week 18)|||Participants|||Count of Participants
660334|NCT01859390|Secondary|Number of Pulmonary Exacerbations|The total number of PEx between baseline (Visit 2) and end of follow up (Week 18).|Baseline (Visit 2) to end of follow up (Week 18)|||Pulmonary Exacerbations|||Number
660335|NCT01859390|Secondary|Time to First Pulmonary Exacerbation|Median time to first pulmonary exacerbation (PEx) between baseline (Visit 2) and end of follow up (Week 18)|Baseline (Visit 2) to end of follow up (Week 18)|||days||95% Confidence Interval|Median
660336|NCT01859390|Secondary|Change in Growth Endpoints|Absolute change in Body Mass Index (BMI) (kg/m^2) between Baseline and Week 16.|Baseline (Visit 2) to Week 16|This population includes participants who did not complete the study (i.e., did not have a final analyzable sputum sample) but did have final height and weight assessments.||kg/m^2||Standard Deviation|Mean
660337|NCT01859390|Secondary|Change in Lung Function|Absolute Change in Forced Expiratory Volume over one second (FEV1) % predicted between Baseline and Week 16. Global Lung Initiative equations were used to calculate FEV1 %predicted.|Baseline (Visit 2) to Week 16|This population includes participants who did not complete the study (i.e., did not have a final analyzable sputum sample) but did have a final lung function assessment.||FEV1 %Predicted||Standard Deviation|Mean
660338|NCT01859390|Secondary|Rate of Adverse Events (AEs) and Serious Adverse Events (SAEs)|Rate is defined as the number of events per participant follow-up week.|18 weeks follow up|||events per participant-week|||Number
660339|NCT01859390|Secondary|Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)|Incidence is defined as the number and percentage of participants with at least one event over the 18 week follow-up period.|18 weeks follow up|||Participants|||Count of Participants
660340|NCT01859390|Primary|Change in Sputum Myeloperoxidase (MPO) Level|The primary outcome is the difference in 16 week mean change in log10 sputum myeloperoxidase levels between the AquADEKs-2 arm and the Control Multivitamin arm.|Baseline (Visit 2) to Week 16 (Visit 4)|||log10 (ng/mL)||Standard Deviation|Mean
660341|NCT01859247|Secondary|Composite Measure of Patient Rating of Symptoms and Tolerability|"This measure will confirm the intervention tolerability by the patient. He/she scored the tolerability from 0-10, 0 being completely tolerable and 10 completely intolerable."|Assessment completed immediately after rTMS treatment session|||units on a scale||Standard Deviation|Mean
660342|NCT01859247|Secondary|Dorsal Premotor-motor Inhibition (dPMI)||Change from baseline dPMI to post-intervention within 1 hour of treatment|two subjects did not have dPMI measured||percentage||Standard Deviation|Mean
660343|NCT01859247|Primary|Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)|Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) was used to assess severity of disease. The score for this section ranges from 0 (absence of severity) to 35 (maximum severity).|Change from baseline pre-intervention TWSTRS score to post-intervention within 1 hour of treatment|||units on a scale||Standard Deviation|Mean
660344|NCT01859143|Secondary|Percentage of Participants Who Required Antipyretic and/or Analgesic Medication||Within 7 and 14 days after vaccination|Safety population included all participants who received any amount of investigational drug and had safety data available. Participants were included in the safety population according to the investigational drug received.||percentage of participants|||Number
660345|NCT01859143|Secondary|Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) and New Onset Chronic Diseases (NOCDs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent SAEs were serious events between administration of study drug and up to 180 days after the dose that were absent before treatment or that worsen relative to pretreatment state. An NOCD was a newly diagnosed medical condition that was of a chronic, ongoing nature and was assessed by the investigator as medically significant. Results are given for TESAEs and NOCDs reported within 28 days and 180 days after vaccination.|Within 28 and 180 days after vaccination|Safety population included all participants who received any amount of investigational drug and had safety data available. Participants were included in the safety population according to the investigational drug received.||participants|||Number
660346|NCT01859143|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs were events between administration of study drug and up to 14 days after vaccination that were absent before treatment or that worsened relative to pre-treatment state. Results are given for AEs reported within 7 days and 14 days after vaccination.|Within 7 and 14 days after vaccination|Safety population included all participants who received any amount of investigational drug and had safety data available. Participants were included in the safety population according to the investigational drug received.||participants|||Number
660388|NCT01857882|Secondary|Patient Involvement in Care Scale (PICS)|PICS is a measure of patient perception of involvement with her care, and has seven 5-point Likert scale items that assess the extent to which the patient asked questions, offered opinions, and expressed concerns when meeting with the surgeon.|T1 (1 week after surgical consultation)||||||
660347|NCT01859143|Secondary|Percentage of Participants With Solicited Symptoms|Solicited symptoms were predefined symptoms or events to be specifically inquired about and assessed daily after vaccine administration up to 14 days after vaccination. The solicited symptoms included fever greater than (>) 100.0 degrees F (37.8 degrees Celsius), runny nose, sore throat, cough, vomiting, muscle aches, chills, decreased activity and headache. Results are reported for all solicited symptoms except fever >=101 degrees F (reported as primary outcome) within 7 days after vaccination and all solicited symptoms within 14 days after vaccination.|Within 7 and 14 days after vaccination|Safety population included all participants who received any amount of investigational drug and had safety data available. Participants were included in the safety population according to the investigational drug received.||percentage of participants|||Number
660348|NCT01859143|Primary|Percentage of Participants With Fever Greater Than or Equal to (>=) 101 Degrees Fahrenheit (F)|Percentage of participants with fever defined as oral temperature >=101 degrees F were reported.|Within 7 days after vaccination|Safety population included all participants who received any amount of investigational drug and had safety data available. Participants were included in the safety population according to the investigational drug received.||percentage of participants|||Number
660349|NCT01859078|Secondary|PK: Renal Clearance (CLr) of Digoxin|CLr is the volume of plasma from which study drug is completely removed by the kidney in a given time and is calculated as Aeτ divided by AUCτ.|Predose to 24 hours post-dose on Days 7 and 16|All enrolled participants who received study drug and had PK data to calculate CLr. Participants were analyzed based on the treatment they received.||Liters/hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
660350|NCT01859078|Secondary|PK: Amount of Drug Excreted Unchanged During 1 Dosing Interval (Aeτ) of Digoxin||0 to 24 hours post-dose on Days 7 and 16|All enrolled participants who received study drug and had PK data to calculate Aeτ. Participants were analyzed based on the treatment they received.||milligrams (mg)||Geometric Coefficient of Variation|Geometric Mean
660351|NCT01859078|Primary|PK: Time of Maximum Observed Drug Concentration (Tmax) of Digoxin||Predose up to 24 hours post-dose on Days 7 and 16|All enrolled participants who received study drug and had PK data to calculate tmax. Participants were analyzed based on the treatment they received.||hours (h)||Full Range|Median
660352|NCT01859078|Primary|PK: Maximum Concentration (Cmax) of Digoxin||Predose up to 24 hours post-dose on Days 7 and 16|All enrolled participants who received study drug and had PK data to calculate Cmax. Participants were analyzed based on the treatment they received.||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
660353|NCT01859078|Primary|Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve During 1 Dosing Interval (AUCτ) of Digoxin||Predose up to 24 hours post-dose on Days 7 and 16|All enrolled participants who received study drug and had PK data to calculate AUCτ. Participants were analyzed based on the treatment they received.||nanograms*hour/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
660354|NCT01859013|Primary|Percent Change From Baseline in Body Mass Index at 28-Weeks|The Percent Change from Baseline in Body Mass Index at 28-Weeks|Baseline and 28-Weeks|||% change BMI||Standard Deviation|Mean
660355|NCT01858766|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as:
On-treatment virologic failure:
Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)
Virologic relapse:
Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 24|Full Analysis Set||percentage of participants|||Number
660356|NCT01858766|Secondary|Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set||percentage of participants||95% Confidence Interval|Number
660357|NCT01858766|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 12 weeks|Safety Analysis Set||percentage of participants|||Number
660358|NCT01858766|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants randomized into the study and received at least 1 dose of study drug.||percentage of participants||95% Confidence Interval|Number
660359|NCT01858701|Primary|Mean Ocular Coma Score at 5mm Pupil at Day 30|Ocular coma is a type of optical aberration or a distortion in image formation occurring when a bundle of light rays enters an optical system (eye) that is not parallel to the optic axis. Ocular coma will be measured in micrometers using a Ladarwave aberrometer. A lower number indicates less coma/less image distortion. One eye (right eye) contributed to the mean.|Day 30|This analysis population includes all participants who completed the study.||micrometers||Standard Deviation|Mean
660360|NCT01858636|Primary|The Percentage of Procedures Achieving Hemostasis Within 5 Minutes of Device Deployment.||within 5 minutes of device deployment|||% of proc. w/hemostasis within 5 min|Participants|95% Confidence Interval|Number
660361|NCT01858636|Primary|The Percentage of Subjects Experiencing a Device or Procedure Related Major Vascular Complication|"Major vascular complications include:
Access Site Complications:
Hematoma >10 cm in size requiring surgical or percutaneous intervention
Major bleeding requiring transfusion of ≥2 units of blood or requiring surgical or percutaneous intervention
Pain requiring a hospitalization extended for more than 24 hours or a new hospitalization, or percutaneous or surgical intervention
Infection requiring a hospitalization extended for more than 24 hours or a new hospitalization or treatment with IV antibiotics
A/V Fistula requiring medical intervention (percutaneous or surgical)
Pseudoaneurysm requiring medical intervention (percutaneous or surgical) b. Lower Limb Ischemia requiring surgical or medical intervention or resulting in permanent injury/impairment c. Retroperitoneal hemorrhage requiring intervention (percutaneous or surgical)"|30 days post procedure|All subjects with device deployments.||% of subjects with MVCs||95% Confidence Interval|Number
660389|NCT01857882|Secondary|Decision Preference and Decision Choice|Decision Preference and Decision Choice has been used as a primary and secondary outcome in studies of decision support interventions in cancer patients. It demonstrates good test-retest reliability (test-retest coefficient > 0.90) and is sensitive to change when measured before and after an intervention.|baseline||||||
660362|NCT01858389|Secondary|Changes From Time-matched Baseline in Adjusted Fridericia Corrected QT Interval (QTcF) on Echocardiogram (ECG)|ECGs recorded on Day 1 of Cycle 0 were used as baseline. For the ECGs assessments, the following directions were followed by the ECG central laboratory: Blinding of ECG readers to treatment, time, and day identifiers. Review of ECGs from a particular participant was performed by a single reader. Prespecification of the lead for internal measurements. Baseline and on-treatment ECG assessments were based on the same lead.|From Baseline to Cycle 0, Day 4|All participants who received all scheduled doses of dacomitinib and had all ECGs performed on Days 1-4 of Cycle 0 (n=number evaluable)||msecs||90% Confidence Interval|Mean
660363|NCT01858389|Secondary|Time to Maximum Plasma Concentration (Tmax) for Dacomitinib and PF-05199265|Tmax was observed directly from data as time of first occurrence. Whole blood for pharmacokinetic analysis was collected immediately after completion of electrocardiograms, blood pressure, and pulse rate.|Pre-dose (hour 0), 2, 4, 6, 8, and 10 hours post-dose on Day 4, Cycle 0.|All participants who received at least 1 dose of study drug and who had at least 1 measured plasma concentration of dacomitinib or its major circulating metabolite PF 05199265.||Hours||Full Range|Median
660364|NCT01858389|Secondary|Maximum Plasma Concentration (Cmax) for Dacomitinib and PF-05199265|Cmax was observed directly from data. Whole blood for pharmacokinetic analysis was collected immediately after completion of electrocardiograms, blood pressure, and pulse rate.|Pre-dose (hour 0), 2, 4, 6, 8, and 10 hours post-dose on Day 4, Cycle 0.|All participants who received at least 1 dose of study drug and who had at least 1 measured plasma concentration of dacomitinib or its major circulating metabolite PF 05199265.||ng/mL||Standard Deviation|Mean
660365|NCT01858389|Primary|Objective Response Rate (ORR) in Participants With T790M Mutation|ORR was calculated as the percentage of participants with a confirmed CR or PR relative to the total number of participants enrolled. Response Evaluation Criteria in Solid Tumors (RECIST), version (v) 1.1 were used to define CR and PR. CR=disappearance of all preexisting lesions except nodal disease, with all nodal lesions decreased to normal size (short axis <10 mm) and no appearance of new unequivocal malignant lesions. PR= ≥30% decrease from baseline of sum of diameters of all target lesions with no unequivocal progression of preexisting non-target lesions or appearance of new lesions. CR and PR were confirmed on a follow-up imaging assessment ≥4 weeks after the initial response documentation. ORR was analyzed only for participants with T790M mutation according to the primary study objective.|From baseline to disease progression, up to 61 weeks.|All enrolled participants with T90M mutation||Percentage of participants||95% Confidence Interval|Number
660366|NCT01858389|Secondary|Progression-free Survival at 4 Months|Progression-free survival at 4 months was defined as the percentage of participants who were alive without disease progression at 4 months relative to all participants enrolled. Disease progression was defined by RECIST v1.1. Objective progression= ≥20% increase in the sum of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5 mm or unequivocal progression of pre-existing non-target lesions or appearance of any new unequivocal malignant lesions.|Month 4|All enrolled participants||Percentage of participants||95% Confidence Interval|Number
660367|NCT01858389|Secondary|Progression-free Survival|Progression-free survival was defined as the time from the date of first dosing of dacomitinib to the date of disease progression by RECIST v1.1, per the investigators’ assessment, or death due to any cause, whichever occurred first. Objective progression= ≥20% increase in the sum of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5 mm or unequivocal progression of pre-existing non-target lesions or appearance of any new unequivocal malignant lesions.|From baseline to disease progression or death, up to 61 weeks.|All enrolled participants||Months||95% Confidence Interval|Median
660368|NCT01858389|Secondary|Duration of Response in Participants With T790M Mutation|Duration of response was defined as the time from first documentation of response (CR or PR, whichever occurred first) to the date of disease progression or to death due to any cause, whichever occurred first. CR and PR were defined using RECIST, v1.1. CR=disappearance of all preexisting lesions except nodal disease, with all nodal lesions decreased to normal size (short axis <10 mm) and no appearance of new unequivocal malignant lesions. PR= ≥30% decrease from baseline of sum of diameters of all target lesions with no unequivocal progression of preexisting non-target lesions or appearance of new lesions. CR and PR were confirmed on a follow-up imaging assessment ≥4 weeks after the initial response documentation. DR was only calculated and summarized for the subgroup of participants with an objective tumor response in the cohort of participants with T790M mutation.|From baseline to date of disease progression or death, up to 61 weeks.|All enrolled participants with T790M mutation status who had an objective tumor response (complete or partial response)||Months|||Number
660369|NCT01858389|Secondary|Disease Control Rate (DCR) for Participants With T790M Mutation|DCR was calculated as the percentage of participants with an objective response (CR or PR) or stable disease, based on the RECIST, v1.1, relative to the total number of participants enrolled in the cohort. If baseline tumor assessment was inadequate for a participant, and the participant could not be assessed for RECIST responses and had no objective status of stable disease documented at least 6 weeks after the start date and before the progression, the participant was only counted in the denominator. CR=disappearance of all preexisting lesions except nodal disease, with all nodal lesions decreased to normal size (short axis <10 mm) and no appearance of new unequivocal malignant lesions. PR= ≥30% decrease from baseline of sum of diameters of all target lesions with no unequivocal progression of preexisting non-target lesions or appearance of new lesions. DCR was analyzed only for participants with T790M mutation according to the study objective.|From baseline to baseline to disease progression, up to 61 weeks.|All enrolled participants with T790M mutation||Percentage of participants||95% Confidence Interval|Number
660386|NCT01857882|Secondary|Qualitative Interview Assessment|A subgroup of participants allocated to both the experimental and usual care groups will be asked to participate in a brief qualitative telephone interview. Purposeful sampling will be used to recruit 5 patients from each group to achieve data saturation and variability. Telephone interviews will be conducted by a social worker trained in qualitative methods. All participants randomized to the workshop will additionally be asked to complete a written survey for evaluation of the intervention immediately after participation in the workshop.|Within three months after initial consultation||||||
660411|NCT01857362|Primary|The Maximum Serum Concentration (Cmax).||Day 1 predose and at 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose|Full analysis set was used; subjects with available PK data for at least one of the treatments.||nM||Full Range|Geometric Mean
660370|NCT01858389|Primary|Best Overall Response (BOR) in Participants With T790M Mutation|BOR was best response from start of treatment until disease progression, according to the RECIST,v1.1. CR=disappearance of all preexisting lesions except nodal disease, with all nodal lesions decreased to normal size (short axis <10 mm) and no appearance of new unequivocal malignant lesions. PR= ≥30% decrease from baseline of sum of diameters of all target lesions with no unequivocal progression of preexisting non-target lesions or appearance of new lesions. CR and PR were confirmed on a follow-up imaging assessment ≥4 weeks after the initial response documentation. Progression= ≥20% increase in the sum of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5 mm or unequivocal progression of pre-existing non-target lesions or appearance of any new unequivocal malignant lesions. Stable disease=not qualify for CR, PR or progression. BOR was analyzed only for participants with T790M mutation according to the primary study objective.|From baseline until disease progression, up to 61 weeks.|All enrolled participants with T790M mutation||Participants|||Number
660371|NCT01858376|Secondary|Changes From Baseline in Platelet Aggregometry|Adenosine Diphosphate (ADP), Arachidonic acid (AA), and Collagen (unsure about the specific type of collagen) agonists will be measured using optical platelet aggregometry. Looking at Baseline to 12 weeks on supplement with a two week washout period|Baseline and 14 weeks|||maximum % aggregation||95% Confidence Interval|Mean
660372|NCT01858376|Secondary|C-reactive Protein|C-reactive protein in blood as measured in a standard hospital laboratory. Looking at Baseline to 12 weeks on supplement with a two week washout period|up to one year||||||
660373|NCT01858376|Secondary|Changes in High-Sensitivity C-reactive Protein|High-Sensitivity C-reactive Protein analysis in blood. Looking at Baseline to 12 weeks on supplement with a two week washout period|Baseline and 14 weeks|||mg/dl||95% Confidence Interval|Mean
660374|NCT01858376|Primary|Change From Baseline in Lipid Profile|Blood lipid panel including HDL, LDL, total cholesterol. Looking at Baseline to 12 weeks on supplement with a two week washout period|Baseline and 14 weeks|number of participants analyzed is different from the participant flow module due to subjects who self reported non-compliance from pill count of the supplements and their data was not able to be used for this outcome measure.||mg/dl||95% Confidence Interval|Mean
660375|NCT01857986|Post-Hoc|Duration of Significant CO2 Leakage|Time (minutes) of CO2 leakage readings at or above 2 mmHg|Subjects will be followed for the duration of endotracheal intubation, an expected average of 4 days|||minutes||Standard Deviation|Mean
660376|NCT01857986|Secondary|Number of the Cuff Pressure Measurements Within the Safety Accepted Range (24 and 40cmH2O)|mean number of cuff pressure measurements within the safety accepted range of 24 and 40 cmH2O, normalized using the total number of valid cuff pressure measurements.|Subjects will be followed for the duration of endotracheal intubation, an expected average of 4 days|||normalized number of Cp measurements||Standard Deviation|Mean
660377|NCT01857986|Primary|CO2 Leakage Above the ETT Cuff, Measured Over Time.|"Trial outcome measure represents patients’ exposure to CO2 leakage standardized per hour. Specifically, each patients’ area under the curve (AUC) of CO2 leakage (mmHg) is computed over the whole trial by multiplying leakage duration (X-axis; continuous time) by CO2 level (Y-axis; mmHg), divided by the patient’s number of hours in the trial. Outcome measure is thus [CO2 mmHg*hour]/hour.
CO2 leakage is the concentration of CO2 above the cuff as measured by the AG100 system every few minutes (in clinical mode). Time points which created the curve were every two adjacent time intervals having a valid CO2 reading."|Subjects will be followed for the duration of endotracheal intubation, an expected average of 4 days|||[CO2 mmHg*hour]/hour||Standard Deviation|Mean
660378|NCT01857882|Other Pre-specified|Completion of Primary Outcome Measure-feasibility Outcome|Patients are to complete the primary outcome one week after initial consultation. However, it is expected that some patients may take longer to complete this intervention (on average 1 month after consultation), and will require reminder telephone calls.|1 week after initial consultation||||||
660379|NCT01857882|Other Pre-specified|Retention After Randomized Treatment Assignment (Workshop and Consultation Attendance)-Feasibility Outcome|The number of participants who completed their assigned treatment (workshop and consultation vs. consultation alone) will be recorded. This will be recorded directly after each day the treatment is delivered.|Duration of treatment-8 hours on day of treatment||||||
660380|NCT01857882|Other Pre-specified|Recruitment Rate-feasibility Outcome|As this is a pilot study, the feasibility of conducting the study is highly important. The recruitment rate of participants will be measured, during the recruiting period which is expected to be on average two months.|Duration of recruiting, expected on average two months||||||
660381|NCT01857882|Secondary|Medical Outcomes Study Social Support Survey|Medical Outcomes Study Social Support Survey has a series of 18 questions that measure 4 domains of social support (emotional, tangible, affectionate, and social interactions). Responses range from 1 (none of the time) to 5 (all the time). The items in each domain were summed and then transformed to yield scores ranging from 0 to 100. Higher scores indicate more support.|baseline||||||
660382|NCT01857882|Secondary|Breast Reconstruction Knowledge Test|This breast reconstruction knowledge test is a 12-item 3-response questionnaire that records the score on a continuous integer scale, and measured patient's knowledge regarding breast reconstruction.|Change in baseline breast reconstruction knowledge at 1 week after initial consultation||||||
660383|NCT01857882|Secondary|Number of Consultations-service Outcomes|The number of consultations with the plastic surgeon until the patient has made a reconstruction choice (defined as signing a surgical consent form) will be recorded. Patients can spend months considering their choices, so it is appropriate to follow them for a period of at least six months after their initial consultation.|Six months after initial consultation||||||
660384|NCT01857882|Secondary|Length of Consultation-service Outcome|The length of the initial consultation with the plastic surgeon, measured in minutes. Consultations are expected to be between 20-60 mins.|Duration of initial consultation||||||
660385|NCT01857882|Secondary|Uptake Rate of Breast Reconstruction-Service Outcome|The uptake rate of breast reconstruction (if patients chose breast reconstruction or no reconstruction)|Six months after initial consultation||||||
660390|NCT01857882|Secondary|Decision Conflict Scale|Decision conflict scale measures personal perceptions of uncertainty in choosing options and has been demonstrated to be valid and responsive to change. The decisional conflict scale is a 16-item 5-response instrument that reports a score from 0 - 100 with higher scores indicating more conflict (items are summed, divided by 16 and multiplied by 25).|Change from baseline decision conflict at 1 week after surgical consultation||||||
660391|NCT01857882|Primary|Decision Self-efficacy Scale|"Decision self-efficacy (DSE) scale is a prospectively designed instrument to evaluate patient self-confidence in decision-making, including shared decision-making. It has been validated among women facing treatment decisions for osteoporosis and used in cancer patients. Psychometric evaluation has shown high levels of internal consistency (Cronbach alpha 0.90). Decision self-efficacy is correlated with decision conflict subscales of feeling informed (r = 0.47) and supported (r = 0.45). This instrument has never been tested in the breast cancer or breast reconstruction population.
The total score is calculated by summing the 11 items, dividing by 11 and multiplying by 25. Scores range from 0 (extremely low self-efficacy) to 100 (extremely high self-efficacy).
The mean and standard deviation (SD) were calculated at baseline and after the initial consultation. Change in score was defined as the difference in total score between baseline and after consultation."|Change from baseline decision self-efficacy at 1 week after surgical consultation|||units on a scale||Standard Deviation|Mean
660392|NCT01857713|Other Pre-specified|Investigator Questionnaire|Investigators provide their perception of the device at the end of the study.|4 Weeks||||||
660393|NCT01857713|Other Pre-specified|Patient Satisfaction|Patients provide their perception of the device at the end of the study.|4 Weeks||||||
660394|NCT01857713|Secondary|Functional Outcomes of Sleep Questionnaire (FOSQ)|The FOSQ is a self-report measure (0-4 for each of 30 questions) designed to assess the impact of disorders of excessive sleepiness (DOES) on multiple activities of everyday living that includes areas of physical, mental and social functioning. Scores can range from 0 (worst possible outcome) to 120 (best possible outcome). Zero (0) is defined as not doing that specific activity for other reasons.|4 Weeks minus Baseline|Patients that have been clinically diagnosed with esophagopharyngeal reflux with extra-esophageal symptoms (i.e., chronic cough, choking, aspiration, chronic post nasal drip, globus, sore throat, throat clearing).||Change in Units on a Scale||Standard Deviation|Mean
660395|NCT01857713|Secondary|SF-36 Short Form Health Survey - 4 Week Follow-up Score Compared to Baseline Score|The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.|4 Weeks minus Baseline|Patients that have been clinically diagnosed with esophagopharyngeal reflux with extra-esophageal symptoms (i.e., chronic cough, choking, aspiration, chronic post nasal drip, globus, sore throat, throat clearing).||Change in Units on a Scale||Standard Deviation|Mean
660396|NCT01857713|Primary|Primary Safety|Adverse reactions reported were evaluated with the frequency and percent of subjects of each reaction being summarized by severity and by relationship to the Reza Band UES Assist Device.|4 Week Follow-up|Patients that have been clinically diagnosed with esophagopharyngeal reflux with extra-esophageal symptoms (i.e., chronic cough, choking, aspiration, chronic post nasal drip, globus, sore throat, throat clearing).||% Reporting Any Adverse Event|||Number
660397|NCT01857713|Primary|Percent Change in the Reflux Symptom Index (RSI) at 4 Weeks|The RSI is a validated nine-item patient-administered outcome questionnaire designed to document symptoms and severity. Patients are asked to rate how nine problems have affected them on a scale of 0 (no problem) to 5 (severe problem), with a maximum total score of 45).|4 Weeks minus Baseline|||Per Cent Change||Standard Deviation|Mean
660398|NCT01857622|Primary|Incidence of Any Adjudicated Bleeding Events|Incidence of any adjudicated bleeding events (including major bleeding, clinically relevant non-major bleeding, and minor bleeding)|3 months|||percentage of subjects with bleeds||95% Confidence Interval|Number
660399|NCT01857583|Secondary|Incidence of Adjudicated Thromboembolic Events|Incidence of adjudicated thromboembolic events (symptomatic Deep Vein Thrombosis (DVT), symptomatic Pulmonary Thromboembolism (PTE), Venous Thromboembolism (VTE) related deaths).|1 month||||||
660400|NCT01857583|Primary|Plasma Concentration of D21-2393||14 days||||||
660401|NCT01857583|Primary|Plasma Concentration of DU-176b||14 days||||||
660402|NCT01857583|Primary|Incidence of Adverse Drug Reactions||1 month||||||
660403|NCT01857583|Primary|Incidence of Adverse Events||1 month||||||
660404|NCT01857583|Primary|Incidence of Any Adjudicated Bleeding Events|Incidence of any adjudicated bleeding events (including major bleeding, clinically relevant non-major bleeding, and minor bleeding).|14 days|The safety analysis set was defined as all subjects who were enrolled in the study, except for those who had significant GCP violations, who had not received the study drug, or who had no safety data after the start of study treatment.||percentage of subjects with bleeds||95% Confidence Interval|Number
660405|NCT01857531|Other Pre-specified|Number of Participants Completing Abstinence From Smoking During the Last Four Weeks of Treatment|End of treatment abstinence from smoking during the last four weeks of treatment, based on self-reported abstinence during last four weeks confirmed by expired air CO|4 Week abstinence from smoking at 6 weeks post quit|||participants||95% Confidence Interval|Number
660406|NCT01857531|Other Pre-specified|Number of Participants Completing Continuous 6-week Abstinence From Smoking|Continuous six week abstinence from smoking at final study visit (approximately 6 weeks post quit date), based on self-reported abstinence confirmed by expired air CO|6 Weeks post quit|Because 6-week abstinence is counted backward from the final study visit, one additional subject (n=4) qualified as abstinent than at 2-weeks post-quit (n=3) due to the fact that the day(s) that one of the subjects smoked did not fall into the range evaluated at 6 weeks.||participants||95% Confidence Interval|Number
660407|NCT01857531|Other Pre-specified|Number of Participants Completing Point Abstinence From Smoking Two Weeks After Quitting|Point abstinence from smoking two weeks post quit, based on self-reported abstinence during last seven days confirmed by expired air CO at first post-quit visit.|7 day point abstinence from smoking at 2 weeks post quit|||participants||95% Confidence Interval|Number
660408|NCT01857531|Other Pre-specified|Number of Participants Completing Continuous 2-week Abstinence From Smoking|Continuous two week abstinence from smoking at the first post-quit visit (approximately 2 weeks post quit date), based on self-reported abstinence confirmed by expired air CO.|2 Weeks post quit|||participants||95% Confidence Interval|Number
660412|NCT01857362|Primary|The Area Under the Serum Concentration vs. Time Profile During 72 Hours After Dose (AUC72h).||Day 1 predose and at 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose|Full analysis set was used; subjects with available PK data for at least one of the treatments.||uM*h||Full Range|Geometric Mean
660413|NCT01857323|Secondary|Participants With Treatment-Emergent Adverse Events|Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 to Day 50|Safety population||participants|||Number
660414|NCT01857323|Secondary|Absolute Value of Total Discrepancy Size Per Inhaler|"The purpose of the study is to determine if the dose counter on Albuterol Spiromax is counting accurately; accuracy is determined by concordance/agreement between patient-reported Albuterol Spiromax counter readings and patient-reported dose cycles recorded in patient diaries. This outcome is calculated for each inhaler as “beginning counter reading minus end counter reading” minus “patient-recorded number of dose cycles. The total inhaler discrepancy size is an important measure because it provides the most relevant means of ensuring that the inhaler does not exhaust its supply of albuterol before the counter has recorded the labeled 200 doses."|Day 1 - Day 50|Per protocol population includes all data from randomized participants who have not experienced major protocol violations prior to dosing with at least 180 inhaled doses. Participants in the 35-day subgroup are excluded from the PP population, as they will only have taken approximately 140 doses during the study.||discrepancies/inhaler||Standard Deviation|Mean
660415|NCT01857323|Secondary|Dosing Discrepancies Per 200 Dose Cycles: Count Up Unknown Dose Cycle|The purpose of the study is to determine if the dose counter on Albuterol Spiromax is counting accurately; accuracy is determined by concordance/agreement between patient-reported Albuterol Spiromax counter readings and patient-reported dose cycles recorded in patient diaries. This outcome measures when the inhaler counter counts upwards (number increases, e.g. 50 to 52) rather than downward between dosing sessions but the participant has not knowingly executed the dose cycle (i.e., the counter number at the beginning of the dosing session is greater than the counter number at the end of the previous dosing session). The discrepancy rate was calculated as “number of discrepancies/total number of dose cycles” *200.|Day 1 - Day 50|Per protocol population includes all data from randomized participants who have not experienced major protocol violations prior to dosing with at least 180 inhaled doses. Participants in the 35-day subgroup are excluded from the PP population, as they will only have taken approximately 140 doses during the study.||discrepancies/200 dose cycles|Participants||Number
660416|NCT01857323|Secondary|Dosing Discrepancies Per 200 Dose Cycles: Count Unknown Dose Cycle|The purpose of the study is to determine if the dose counter on Albuterol Spiromax is counting accurately; accuracy is determined by concordance/agreement between patient-reported Albuterol Spiromax counter readings and patient-reported dose cycles recorded in patient diaries. This outcome measures when the inhaler counter advances (decreases, e.g., 50 to 48) between dosing sessions but the participant has not knowingly executed the dose cycle (i.e., the counter number at the beginning of the dosing session is less than the counter number at the end of the previous dosing session). The discrepancy rate was calculated as “number of discrepancies/total number of dose cycles” *200.|Day 1 - Day 50|Per protocol population includes all data from randomized participants who have not experienced major protocol violations prior to dosing with at least 180 inhaled doses. Participants in the 35-day subgroup are excluded from the PP population, as they will only have taken approximately 140 doses during the study.||discrepancies/200 dose cycles|Participants||Number
660417|NCT01857323|Secondary|Dosing Discrepancies Per 200 Dose Cycles: Dose Cycle Count Up|The purpose of the study is to determine if the dose counter on Albuterol Spiromax is counting accurately; accuracy is determined by concordance/agreement between patient-reported Albuterol Spiromax counter readings and patient-reported dose cycles recorded in patient diaries. This outcome measures when the inhaler counter reading increases, instead of decreases, after the participant has executed the dose cycle (i.e., the ending counter reading is greater than the beginning counter reading within a dosing session). The discrepancy rate was calculated as “number of discrepancies/total number of dose cycles” *200.|Day 1 - Day 50|Per protocol population includes all data from randomized participants who have not experienced major protocol violations prior to dosing with at least 180 inhaled doses. Participants in the 35-day subgroup are excluded from the PP population, as they will only have taken approximately 140 doses during the study.||discrepancies/200 dose cycles|Participants||Number
660418|NCT01857323|Primary|Dosing Discrepancies Per 200 Dose Cycles: Dose Cycle Not Count|The purpose of the study is to determine if the dose counter on Albuterol Spiromax is counting accurately; accuracy is determined by concordance/agreement between patient-reported Albuterol Spiromax counter readings and patient-reported dose cycles recorded in patient diaries. This outcome measures how often the dose cycle was not counted: the participant completes a full dose cycle (opens the mouthpiece cap, inhales the medication, and closes the mouthpiece cap) but the counter display does not advance (i.e., does not count down) within a dosing session. The discrepancy rate was calculated as “number of discrepancies/total number of dose cycles” *200.|Day 1 - Day 50|Per protocol population includes all data from randomized participants who have not experienced major protocol violations prior to dosing with at least 180 inhaled doses. Participants in the 35-day subgroup are excluded from the PP population, as they will only have taken approximately 140 doses during the study.||discrepancies/200 dose cycles|Participants||Number
660419|NCT01857297|Secondary|Frequency of Any Unsolicited AEs|The percentage of participants reporting any unsolicited AEs. Unsolicited AEs include AEs other than those specifically solicited.|After vaccination until the end of the study; approximately 21 days.|The Safety Population included all participants who received the Influenza Vaccine and provided follow-up safety data.||percentage of participants|||Number
660420|NCT01857297|Secondary|Frequency of Any Solicited Adverse Events (AEs)|The percentage of participants reporting any solicited AEs.|During the 4 days after vaccination (Day 0 plus 3 days)|The Safety Population included all participants who received the Influenza Vaccine and provided follow-up safety data.||percentage of participants|||Number
661971|NCT01830933|Primary|Percentage of Participants Who Had a Discussion of Breast Cancer Risk|Self-reported discussion of breast cancer risk with physicians.|one week post-initial visit (approximately one week)|||percentage of participants|||Number
660421|NCT01857297|Primary|The Percentage of Evaluable Participants Achieving a HI Titre ≥ 40 or Single Radial Haemolysis (SRH) Area ≥ 25 mm2.|For the H1N1, H3N2 and B influenza virus strains. Note: No SRH data were collected.|Approximately 21 days after vaccination|The Evaluable Population included all participants who were vaccinated with the Influenza Vaccine, provided both pre- and post-vaccination antibody titer results, did not use a prohibited medication as per the protocol, and were not excluded from the analysis according to the elimination criteria.||percentage of participants||95% Confidence Interval|Number
660422|NCT01857297|Primary|The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination.|GMFI (H1N1, H3N2, and B influenza virus strains) is defined as the geometric mean of the fold increases of post-vaccination antibody titre over the pre-vaccination antibody titre.|Approximately 21 days after vaccination|The Evaluable Population included all participants who were vaccinated with the Influenza Vaccine, provided both pre- and post-vaccination antibody titer results, did not use a prohibited medication as per the protocol, and were not excluded from the analysis according to the elimination criteria.||fold increase||Standard Deviation|Geometric Mean
660423|NCT01857297|Primary|The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre.|As per the criteria specified in the CPMP/BWP/214/96 Note for Guidance on Harmonisation of Requirements for Influenza Vaccines. For haemagglutination inhibition (HI), seroconversion (H1N1, H3N2, and B influenza virus strains) is defined as achieving a post-vaccination titre of ≥ 40 for those participants with a pre-vaccination HI titre of < 10. A significant increase (H1N1, H3N2, and B influenza virus strains) is defined as a four-fold or greater increase in HI titre for those participants with a pre-vaccination HI titre of ≥ 10.|Approximately 21 days after vaccination|The Evaluable Population included all participants who were vaccinated with the Influenza Vaccine, provided both pre- and post-vaccination antibody titer results, did not use a prohibited medication as per the protocol, and were not excluded from the analysis according to the elimination criteria.||percentage of participants||95% Confidence Interval|Number
660424|NCT01857258|Secondary|Ratio of Asymmetric Dimethylarginine Relative to Arginine||60 min (baseline)|||nmol/umol||Standard Error|Mean
660425|NCT01857258|Secondary|Ratio of Asymmetric Dimethylarginine Relative to Arginine||0 min (baseline)|||nmol/umol||Standard Error|Mean
660426|NCT01857258|Secondary|Malondialdehyde||60 min postprandially|||uM||Standard Error|Mean
660427|NCT01857258|Secondary|Malondialdehyde (0 Min)||Baseline (0 min)|||uM||Standard Error|Mean
660428|NCT01857258|Primary|Brachial Artery Flow-mediated Dilation||60 min|||% dilation||Standard Error|Mean
660429|NCT01857258|Primary|Brachial Artery Flow-mediated Dilation||0 min (baseline)|||% dilation||Standard Error|Mean
660430|NCT01857258|Primary|Area Under the Curve of Brachial Artery Flow Mediated Dilatiion|Brachial artery flow-mediated dilation will be measured at 0, 30, 60, 90, 120, 150, and 180 minutes following the ingestion of a confection.|Area under the Curve, 0, 30, 60, 90, 120, 150, 180 minutes post-dose|||%FMD * min||Standard Error|Mean
660431|NCT01857258|Primary|Area Under the Curve of Blood Glucose|Blood glucose will be measured at 0, 30, 60, 90, 120, 150 and 180 minutes following the ingestion of a confection to calculate area under the concentration-time curve.|Area under the Curve, 0, 30, 60, 90, 120, 150, 180 minutes post-dose|||mmol/L * min||Standard Error|Mean
660432|NCT01857206|Primary|Number Of Subjects Reporting Unsolicited Serious Adverse Events After Any Vaccination.|Safety was assessed as the number of subjects who reported serious adverse events (SAEs), medically attended AEs and new onset of chronic diseases (NOCD) in subjects aged ≥4 To ≤17 Years.|Day 1 to Day 183 for previously vaccinated subjects and Day 213 for not-previously vaccinated subjects|Analysis was done on the unsolicited safety dataset, i.e. the subjects in the exposed population who provided postvaccination unsolicited safety data.||Subjects|||Number
660433|NCT01857206|Primary|Number Of Subjects Reporting Unsolicited Adverse Events After Any Vaccination.|Safety was assessed as the number of subjects who reported unsolicited adverse events following vaccination with either mammalian cell culture-derived or egg-derived trivalent influenza vaccination in subjects aged ≥4 To ≤17 Years.|Day 1 to Day49 for subjects aged ≥4 To ≤8 years not previously vaccinated. Day 1 to Day 38 for subjects aged ≥4 To ≤8 years previously vaccinated and all subjects aged ≥9 To ≤17 years.|Analysis was done on the unsolicited safety dataset, i.e. the subjects in the exposed population who provided postvaccination unsolicited safety data.||Subjects|||Number
660434|NCT01857206|Primary|Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination.|Safety was assessed as the number of subjects who reported solicited local and systemic adverse events and other indicators of reactogenicity following two doses of either mammalian cell culture-derived or egg-derived trivalent influenza vaccination in subjects aged ≥4 To ≤17 Years.|Day 1 to Day 7 after any vaccination|Analysis was done on the solicited safety dataset, i.e. the subjects in the exposed population who provided postvaccination solicited safety data.||Subjects|||Number
660435|NCT01857102|Primary|Visual Comfort|The Visual comfort (diurnal fluctuation[DF]) scores were derived from the National Eye Institute Refractive Error Quality of Life (NEI-RQL) instruments- specifically the diurnal fluctuations sub-scale, by following the instruction given in the NEI-RQL-42 User Manual, Version 1.0. The NEI-RQL is a validated patient reported outcome questionnaire to assess the impact of refractive correction on vision specifically to quality of life. This survey consisted of 42 items used to develop 13 subscales: clarity of vision, expectations, near vision, far vision, diurnal fluctuations, activity limitations, glare, symptoms, dependence on correction, worry, suboptimal correction, appearance, and satisfaction with correction. An overall score is calculated by averaging the subscales. The overall scores can take on values of 0 to 100. Higher scores indicate better outcomes|1-week follow-up|The analysis population consists of all subjects that completed all study visits without a major protocol deviation.||units on a scale||Standard Deviation|Mean
663861|NCT01797029|Secondary|Safety Profile of LAIV: Solicited and Unsolicited Local and Systemic Reactions||Through one week post-vaccination||||||
660436|NCT01857102|Primary|Objective Comfort Assessed by Electromyography(EMG)|Electromyography (EMG) utilizes electrodes affixed to the skin below the eyelid, which measures activity of the orbital portion of the orbicularis oculi muscle. The orbital portion of the orbicularis oculi muscle pulls on the skin of the forehead, temple and cheek and draws it toward a point at the edge of the orbit. This part of the muscle is mainly under voluntary control, and it what is contracted during the process of squinting. The palpebral portion of this muscle closes the eyelids. The EMG reading was performed while the subject was wearing contact lenses in order to objectively assess eyestrain.The higher the EMG reading indicated the more the eyestrain. The original EMG data collected from a 40-second recording consisted of approximately 40,000 observations; the machine read about 1000 observations per second consecutively during 40-second recording. The original EMG reading was converted to a single data point and entered in the EDC for the analysis purpose.|1 week|Analysis population consists of all subjects that completed all study visits without a major protocol deviation.||volts||Standard Deviation|Mean
660437|NCT01857063|Secondary|Change From Baseline in Sneezing Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room|The Sneezing Score was assessed as 0 = 0 times participant sneezed to 4 = 21 or more times participant sneezed. The possible Sneezing Score ranged from 0 to 4, with a higher score indicating more severe sneezing. The Sneezing Score was assessed on Day 7 prior to entering the chamber room and at 30, 60, 90, 120, 150 and 180 minutes after entering the chamber room. Analysis was done by study drug as taken.|Baseline and at 30, 60, 90, 120, 150 and 180 minutes after entering chamber room on Day 7 of a treatment period|The FAS population consisted of all randomized participants who took at least one dose of study drug, and had a baseline assessment and at least one post-baseline assessment in a treatment period.||score on a scale||95% Confidence Interval|Least Squares Mean
660438|NCT01857063|Secondary|Change From Baseline in Nasal Discharge Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room|The Nasal Discharge Score was assessed as 0 = 0 times participant blew his/her nose to 4 = 21 or more times participant blew his/her nose. The possible Nasal Discharge Score ranged from 0 to 4, with a higher score indicating more severe nasal discharge.The Nasal Discharge Score was assessed on Day 7 prior to entering the chamber room and at 30, 60, 90, 120, 150 and 180 minutes after entering the chamber room. Analysis was done by study drug as taken.|Baseline and at 30, 60, 90, 120, 150 and 180 minutes after entering chamber room on Day 7 of a treatment period|The FAS population consisted of all randomized participants who took at least one dose of study drug, and had a baseline assessment and at least one post-baseline assessment in a treatment period.||score on a scale||95% Confidence Interval|Least Squares Mean
660439|NCT01857063|Secondary|Change From Baseline in Nasal Congestion Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room|The Nasal Congestion Score was assessed as 0 = No symptoms of nasal congestion to 4 = Completely obstructed all day. The possible Nasal Congestion Score ranged from 0 to 4, with a higher score indicating more severe nasal congestion.The Nasal Congestion Score was assessed on Day 7 prior to entering the chamber room and at 30, 60, 90, 120, 150 and 180 minutes after entering the chamber room. Analysis was done by study drug as taken.|Baseline and at 30, 60, 90, 120, 150 and 180 minutes after entering chamber room on Day 7 of a treatment period|The FAS population consisted of all randomized participants who took at least one dose of study drug, and had a baseline assessment and at least one post-baseline assessment in a treatment period.||score on a scale||95% Confidence Interval|Least Squares Mean
660440|NCT01857063|Secondary|Change From Baseline in Weighted TNSS at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room|TNSS was weighted as 2:1:1 for nasal congestion, nasal discharge and sneezing. The possible Weighted TNSS ranged from 0 to 16, with a higher score indicating more severe total nasal symptoms. The baseline TNSS was assessed on Day 7 of a treatment period prior to entering the chamber room. The post-baseline Weighted TNSS was assessed on Day 7 of a treatment period at 30, 60, 90, 120, 150 and 180 minutes after entering the chamber room. Analysis was done by study drug as taken.|Baseline and at 30, 60, 90, 120, 150 and 180 minutes after entering chamber room on Day 7 of a treatment period|The FAS population consisted of all randomized participants who took at least one dose of study drug, and had a baseline assessment and at least one post-baseline assessment in a treatment period.||score on a scale||95% Confidence Interval|Least Squares Mean
660441|NCT01857063|Secondary|Change From Baseline in TNSS at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room|The TNSS is the sum of the three nasal symptom scores for nasal congestion, nasal discharge and sneezing. The possible TNSS ranged from 0 to 12, with a higher score indicting more severe total nasal symptoms. The baseline TNSS was assessed on Day 7 of a treatment period prior to entering the chamber room. The post-baseline TNSS was assessed on Day 7 of a treatment period at 30, 60, 90, 120, 150 and 180 minutes after entering the chamber room. Analysis was done by study drug as taken.|Baseline and at 30, 60, 90, 120, 150 and 180 minutes after entering chamber room on Day 7 of a treatment period|The FAS population consisted of all randomized participants who took at least one dose of study drug, and had a baseline assessment and at least one post-baseline assessment in a treatment period.||score on a scale||95% Confidence Interval|Least Squares Mean
660442|NCT01857063|Secondary|Change From Baseline in Sneezing Score Averaged During 3 Hours of Exposure|The Sneezing Score was assessed as 0 = 0 times participant sneezed to 4 = 21 or more times participant sneezed, with a possible Sneezing Score ranging from 0 to 4 and a higher score indicating more severe sneezing. The baseline Sneezing Score was assessed on Day 7 of a treatment period prior to entering the chamber room. The post-baseline Sneezing Score was assessed on Day 7 of a treatment period during 3 hours of exposure to JC pollen in the chamber room, as an average of measurements at 30, 60, 90, 120, 150 and 180 minutes. Analysis was done by study drug as taken.|Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period|The FAS population consisted of all randomized participants who took at least one dose of study drug, and had a baseline assessment and at least one post-baseline assessment in a treatment period.||score on a scale||95% Confidence Interval|Least Squares Mean
660443|NCT01857063|Secondary|Change From Baseline in Nasal Discharge Score Averaged During 3 Hours of Exposure|The Nasal Discharge Score was assessed as 0 = 0 times participant blew his/her nose to 4 = 21 or more times participant blew his/her nose, with a possible Nasal Discharge Score ranging from 0 to 4 and a higher score indicating more severe nasal discharge. The baseline Nasal Discharge Score was assessed on Day 7 of a treatment period prior to entering the chamber room. The post-baseline Nasal Discharge Score was assessed on Day 7 of a treatment period during 3 hours of exposure to JC pollen in the chamber room, as an average of measurements at 30, 60, 90, 120, 150 and 180 minutes. Analysis was done by study drug as taken.|Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period|The FAS population consisted of all randomized participants who took at least one dose of study drug, and had a baseline assessment and at least one post-baseline assessment in a treatment period.||score on a scale||95% Confidence Interval|Least Squares Mean
660444|NCT01857063|Secondary|Change From Baseline in Nasal Congestion Score Averaged During 3 Hours of Exposure|The Nasal Congestion Score was assessed as 0 = No symptoms of nasal congestion to 4 = Completely obstructed all day, with a possible Nasal Congestion Score ranging from 0 to 4 and a higher score indicating more severe nasal congestion. The baseline Nasal Congestion Score was assessed on Day 7 of a treatment period prior to entering the chamber room. The post-baseline Nasal Congestion Score was assessed on Day 7 of a treatment period during 3 hours of exposure to JC pollen in the chamber room, as an average of measurements at 30, 60, 90, 120, 150 and 180 minutes. Analysis was done by study drug as taken.|Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period|The FAS population consisted of all randomized participants who took at least one dose of study drug, and had a baseline assessment and at least one post-baseline assessment in a treatment period.||score on a scale||95% Confidence Interval|Least Squares Mean
660445|NCT01857063|Secondary|Change From Baseline in Weighted TNSS Averaged During 3 Hours of Exposure|TNSS was weighted as 2:1:1 for nasal congestion, nasal discharge and sneezing. The Weighted TNSS ranged from 0 to 16, with a higher score indicating more severe weighted total nasal symptoms. The baseline Weighted TNSS was assessed on Day 7 of a treatment period prior to entering the chamber room. The post-baseline TNSS was assessed on Day 7 of a treatment period during 3 hours of exposure to JC pollen in the chamber room, as an average of measurements at 30, 60, 90, 120, 150 and 180 minutes. Analysis was done by study drug as taken.|Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period|The FAS population consisted of all randomized participants who took at least one dose of study drug, and had a baseline assessment and at least one post-baseline assessment in a treatment period.||score on a scale||95% Confidence Interval|Least Squares Mean
660446|NCT01857063|Primary|Percentage of Participants Who Experience at Least One Adverse Event|An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Participants were monitored for occurrence adverse events for up to 14 days after last dose of study drug. Analysis was done by study drug as taken.|Up to 5 weeks|The All Patients as Treated (APaT) population consisted of all randomized participants who received at least one dose of study drug.||percentage of participants|||Number
660447|NCT01857063|Primary|Change From Baseline in Total Nasal Symptom Score (TNSS) Averaged During 3 Hours of Exposure|The TNSS is the sum of the three nasal symptom scores for nasal congestion, nasal discharge and sneezing. Participants completed a questionnaire about their nasal symptoms. Score ranged from 0 to 4 for each of the three nasal symptoms, with a total possible score ranging from 0 to 12 and a higher score indicating more severe nasal symptoms. The baseline TNSS was assessed on Day 7 of a treatment period prior to entering the chamber room. The post-baseline TNSS was assessed on Day 7 of a treatment period during 3 hours of exposure to Japanes cedar (JC) pollen in the chamber room, as an average of measurements at 30, 60, 90, 120, 150 and 180 minutes. Analysis was done by study drug as taken.|Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period|The Full Analysis Set (FAS) population consisted of all randomized participants who took at least one dose of study drug, and had a baseline assessment and at least one post-baseline assessment in a treatment period.||score on a scale||95% Confidence Interval|Least Squares Mean
660448|NCT01856933|Secondary|Toxicities (Adverse Events) of PSMA ADC for Patients With Recurrent Glioblastoma.||at least every 3 weeks for a maximum of 30 post coming off drug, approximtely 6 months||||||
660449|NCT01856933|Primary|Response Rate (Progression) for Patients With Glioblastoma That Have Progressed After Prior Treatment That Has Included Radiation, Temozolomide and Bevacizumab.|"The response assessment in neuro-oncology (RANO) will be used to define radiographic response.
(PD): A >25% increase in tumor area (product of two diameters) OR appearance of a new lesion/site, OR clear clinical worsening or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer)."|3 months until progression, potentially up to 1 year|Progression||participants|||Number
660450|NCT01856764|Secondary|Change From Baseline to Day 15 in Participants’ Assessment of Pruritus|Severity of pruritus is assessed by the participants and recorded on a numeric scale ranging from 0 to 10, where 0 indicates the absence of the symptoms and 10 indicates the most severe symptoms.|Baseline and Day 15|All randomized participants who received at least one application of any double-blind study medication with a score at Day 15. One subject in the 0.5% Roflumilast group was missing Day 15 data.||Scores on a scale||Standard Error|Least Squares Mean
660451|NCT01856764|Secondary|Change From Baseline to Day 15 in Transepidermal Water Loss (TEWL) Values|Diffusion of water through the skin is measured using a Tewameter. At each visit, 3 measurements are taken per treatment area (at 3 different areas of the target lesion). The TEWL value at each visit is the average of these measurements.|Baseline and Day 15|All randomized participants who received at least one application of any double-blind study medication with a score at Day 15. One subject in the 0.5% Roflumilast group was missing Day 15 data.||g/m^2/hr||Standard Error|Least Squares Mean
660452|NCT01856764|Primary|Change From Baseline to Day 15 in Modified Local SCORing Atopic Dermatitis (SCORAD)|Modified Local SCORAD is the sum of 5 individual indexes; erythema, edema/papulation, oozing/crusts, excoriations and lichenification scored on a 4 point scale, where 0=absent and 3=severe, with a total possible score of 15. Higher scores indicate greater severity.|Baseline and Day 15|All randomized participants who received at least one application of any double-blind study medication with a score at Day 15. One subject in the 0.5% Roflumilast group was missing Day 15 data.||Scores on a scale||Standard Error|Least Squares Mean
660471|NCT01856673|Secondary|Score Difference in Total Mental Health Symptoms (TMHS) and Dysfunction|"TMHS scale of 64 items, ranging from 0 for “never” to 3 for “all the time” being the option three the worst condition, including locally relevant symptoms and sub-scales of depression (n=15 symptoms), anxiety (n=10 symptoms) and post-traumatic stress symptoms (PTSS) (n=16 symptoms). Depression and anxiety symptoms were assessed using the Hopkins Symptom Checklist (HSCL-25) and symptoms of trauma (PTSS) were assessed using the Harvard Trauma Questionnaire (HTQ).
The Dysfunction measure was a gender-specific questionnaire with 12-items for females and 10-items for males. Each item assessed a task ranging from 0 for “no difficulty” to 4 for “cannot do it”, being the option four the worst condition.
For each scale, the mean was calculated in order to used it as the measure for comparisions.
Mean difference in scores of TMHS and Dysfunction between the subject’s baseline and the final assessments according to the study instrument."|Within the fifteen (15) days after finishing the intervention, either Common Elements Treatment Approach (CETA) or Narrative Community Group Therapy (NCGT). In the control group, 12 weeks after the baseline assessment.|||units on a scale||95% Confidence Interval|Mean
660472|NCT01856673|Primary|Score Difference in Symptoms of Anxiety, Depression and Post-traumatic Stress Disorders.|"Symptoms, ranging from 0 for “never” to 3 for “all the time” being three the worst score, were assessed with adapted versions of Hopkins Symptom Checklist and Harvard Trauma Questionnaire, from which they were analyzed the constructs of depression (n=15 symptoms), anxiety (n=10 symptoms) and post-traumatic stress symptoms (n=16 symptoms). Depression and anxiety symptoms were assessed using the Hopkins Symptom Checklist (HSCL-25) and symptoms of trauma (PTSS) were assessed using the Harvard Trauma Questionnaire (HTQ).
For each scale, the mean was calculated in order to used it as the measure for comparisions.
Mean difference in scores of symptoms of anxiety, depression and post-traumatic stress disorders between the subject’s baseline and the final assessments according to the study instrument."|Within the fifteen (15) days after finishing the intervention, either Common Elements Treatment Approach (CETA) or Narrative Community Group Therapy (NCGT). In the control group, 12 weeks after the baseline assessment.|||units on a scale||95% Confidence Interval|Mean
660473|NCT01856569|Secondary|Erythrocyte Sedimentation Rate at Baseline|Erythrocyte sedimentation rate was a laboratory test that provided a non-specific measure of inflammation. The test assessed the rate at which red blood cells fell in a test tube and was measured in millimeter per hour (mm/h).|Baseline|FAS included all participants who met the inclusion criteria.||millimeter per hour||Standard Deviation|Mean
660474|NCT01856569|Secondary|C Reactive Protein Level at Baseline|C reactive protein was measured from blood samples as a marker for inflammation. Higher levels were indicative of more inflammation.|Baseline|FAS included all participants who met the inclusion criteria. Here, number of participants analyzed (N) signifies number of participants evaluable for this outcome measure.||milligram per liter||Standard Deviation|Mean
660475|NCT01856569|Secondary|Ankylosing Spondylitis Quality of Life (ASQoL) Total Score at Month 18|ASQoL was a disease-specific questionnaire that assessed the impact of AS on participant’s quality of life (QoL). It consisted of 18 questions to be completed by the participant. Each question was answered by the participant as a 'Yes' (scored as 1) or 'No' (scored as 0). Scores of each individual question was summed to give a total score that ranges from 0 (good QoL) to 18 (poor QoL), where lower scores indicated good quality of life. Data for this outcome was planned to be reported separately for switchers (participants who switched to a second anti-TNF drug during observation period) and non-switchers (participants who did not switched to a second anti-TNF drug during observation period).|Month 18|"FAS included all participants who met the inclusion criteria. Here, n signifies number of participants evaluable each specified category."||units on a scale||Standard Deviation|Mean
660476|NCT01856569|Primary|Percentage of Participants With Unchanged First Line Anti-TNF Treatment In State of Low Disease Activity|Low disease activity was defined as a BASDAI score of less than or equal to (<=) 2. BASDAI was a validated self-assessment tool used to determine disease activity in participants with AS. The total BASDAI score ranges from 0=none to 10=severe, where lower score indicated less disease activity. In this outcome, percentage of participants with unchanged first line anti-TNF drug (nor dose neither frequency, but drug only) in the state of low disease activity, during the specified time points were reported.|Month 12, 18|"FAS included all participants who met the inclusion criteria. Here, n signifies number of participants evaluable for each time point."||percentage of participants|||Number
660477|NCT01856569|Primary|Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at Month 18|BASDAI was a validated self-assessment tool used to determine disease activity in participants with AS. Utilizing a numerical rating scale (NRS) of 0-10 (0 = no problem to 10 = worst problem) participants answered 6 questions measuring symptoms of AS (spinal pain, fatigue, joint pain or swelling, areas of localized tenderness, morning stiffness duration and severity). The BASDAI total score was calculated by computing the mean of questions 5 and 6 and adding it to the sum of questions (Q) 1-4. This score was then divided by 5. BASDAI=Q1+Q2+Q3+Q4+[Q5+Q6/2]/5. The total BASDAI score ranges from 0=none to 10=severe, where lower score indicated less disease activity.|Baseline, Month 18|FAS included all participants who met the inclusion criteria. Here, number of participants analyzed (N) signifies number of participants evaluable for this outcome measure.||units on a scale||Standard Deviation|Mean
660478|NCT01856569|Primary|Percentage of Participants With Unchanged First Line Anti-TNF Treatment Up to Month 18|First line anti-TNF treatment included adalimumab, etanercept, golimumab and infliximab. In this outcome, percentage of participants who were taking any one of the first line anti-TNF treatment at baseline and maintained the same up to Month 18 without any change in prescription, were reported.|Baseline up to Month 18|FAS included all participants who met the inclusion criteria.||percentage of participants|||Number
660479|NCT01856530|Secondary|Perceived Rejection Scores on a 1-7 Likert Scale|Participants will rate their level of perceived rejection (on a 1-7 Likert scale) from Player 1 during online ball-tossing task. Higher scores on this scale reflect greater perceived rejection from Player 1.|Day 1 (first day oxytocin or placebo was administered)|Due to technical difficulties during the computer task, two participants did not complete this questionnaire and were not included in this analysis. Thus, only 52 participants were included in this analysis.||units on a scale||Standard Deviation|Mean
660870|NCT01851330|Primary|Incidence of Adverse Events Leading to Permanent Discontinuation From Any Study Drug|The percentage of participants who experienced an adverse event leading to permanent discontinuation from any study drug was summarized.|Up to 12 weeks|Safety Analysis Set||percentage of participants|||Number
660480|NCT01856530|Secondary|Perceived Preference Scores on a 1-7 Likert Scale|Participants will rate their level of preference (on a 1-7 Likert scale) for Player 1 during online ball-tossing task. Higher scores on this scale reflect greater preference for Player 1.|Day 1 (first day oxytocin or placebo was administered)|Due to technical difficulties during the computer task, two participants did not complete this questionnaire and were not included in the analysis. Thus, only 52 participants were included in this analysis.||units on a scale||Standard Deviation|Mean
660481|NCT01856530|Secondary|Perceived Empathy Scores on a 1-7 Likert Scale|Participants will rate their level of perceived empathy (on a 1-7 Likert scale) with Player 1 during online ball-tossing task. Higher scores on this scale reflect greater perceived empathy toward Player 1.|Day 1 (first day oxytocin or placebo was administered)|Due to technical difficulties during the computer task, two participants did not complete this questionnaire and were not included in the analysis. Thus, only 52 participants were included in this analysis.||units on a scale||Standard Deviation|Mean
660482|NCT01856530|Secondary|Perceived Trust Scores on a 1-7 Likert Scale|Participants will rate their perceived level of trust (on a 1-7 Likert scale) toward Player 1 during online ball-tossing task. Higher ratings on this scale reflect greater perceived trust toward Player 1.|Day 1 (first day oxytocin or placebo was administered)|Due to technical difficulties during the computer task, two participants did not complete this questionnaire and were not included in the analysis. Thus, only 52 participants were included in this analysis.||units on a scale||Standard Deviation|Mean
660483|NCT01856530|Primary|Disengagement From Social Threat Cues|The outcome measure involved difference scores in response latencies on disengagement trials for disgust versus neutral cues. Difference scores were calculated as response latencies during disengagement trials for disgust cues minus response latencies during disengagement trials for neutral cues. Negative change scores represent an improvement in disengagement.|Day 1 (first day oxytocin or placebo was administered)|||Milliseconds||Standard Deviation|Mean
660484|NCT01856530|Primary|Social Cooperation|"The outcome measure involved difference scores in the number of balls tossed to Player 1 between two conditions of the task. Across both conditions, the participant (always assigned as Player 2) played with 3 other on-line players in real time. In Condition 1, Player 1 was programmed to toss on average 70% of his balls to the participant. In Condition 2, Player 1's behavior switched such that he was programmed to toss on average only 10% of his balls to the participant. The data reported below is the number of balls tossed to Player 1 in Condition 2 minus balls tossed under Condition 1."|Day 1 (first day oxytocin or placebo was administered)|Data from 2 participants could not be analyzed due to technical difficulties with the computer task. Thus, the number of participants analyzed was 52 in total, rather than 54.||Ball tosses||Standard Deviation|Mean
660485|NCT01856361|Other Pre-specified|Seminal Angiotensin II and Serum Bradykinin Levels||32 weeks|Data was not collected on the 2 participants as the principal investigator on this trial moved to a different practice and thus the study terminated before any results could be analyzed.|||||
660486|NCT01856361|Secondary|Hormonal Profile|LH, FSH, serum testosterone, prolactin|32 weeks|Data was not collected on the 2 participants as the principal investigator on this trial moved to a different practice and thus the study terminated before any results could be analyzed.|||||
660487|NCT01856361|Secondary|Pregnancy Rate||32 weeks|Data was not collected on the 2 participants as the principal investigator on this trial moved to a different practice and thus the study terminated before any results could be analyzed.|||||
660488|NCT01856361|Secondary|Total Motile Sperm Count(TMSC), Total Sperm Count, Sperm Motility, and Morphology in the Ejaculate.|The efficacy of ramipril in improving total sperm count will be evaluated, as well as, improving sperm motility, and morphology.|32 weeks|Data was not collected on the 2 participants as the principal investigator on this trial moved to a different practice and thus the study terminated before any results could be analyzed.|||||
660489|NCT01856361|Primary|Sperm Density in Infertile Men With Documented Oligospermia.||32 weeks|Data was not collected on the 2 participants as the principal investigator on this trial moved to a different practice and thus the study terminated before any results could be analyzed.|||||
660490|NCT01856322|Primary|Difference in Circulating S100A4 Transcript in Patients Receiving Sulindac 150 mg BD (Twice Daily) by Mouth Following Resection of Colorectal Cancer Metastases Compared to Those Who do Not.|Difference in circulating S100A4 transcript levels will be determined by assessing the circulating S100A4 transcript level at initial presentation versus the circulating S100A4 transcript level post resection.|3 years|The trial was prematurely closed due to lack of accrual, thus the outcome measure was not met.|||||
660491|NCT01856257|Secondary|Count of Participants With Fever > 39 Degrees Celsius and Blood Pressure < 90 mmHg Within 24 Hours of Onset of Transplant Procedure|Temperature of >39 degrees Celsius (e.g., 102.2 degrees Fahrenheit) would be an indication of fever most often in response to an infection or illness. Systolic blood pressure <90mm Hg would be an indication of low blood pressure.|Within 24 Hours of transplant procedure|Intent-to-treat population||Participants|||Count of Participants
660492|NCT01856257|Secondary|Count of Participants With Epstein-Barr Virus (EBV) Infection as Reported on the Case Report Form as Adverse Events|Viral infections following renal transplantation, including but not limited to EBV infection, is a significant source of recipient morbidity and mortality, and a significant cause of allograft dysfunction and loss.|Transplantation through Week 52|Intent-to-treat population||Participants|||Count of Participants
660493|NCT01856257|Secondary|Count of Participants With BK Polyoma Virus (BKV) and Cytomegalovirus (CMV) Viremia (Local Center Monitoring) as Adverse Events by Wk 52 Post-Transplant|Viral infections following renal transplantation is significant source of recipient morbidity and mortality, and a significant cause of allograft dysfunction and loss. Specific viruses were monitored during the study, using participant blood samples. Displayed are counts of participants who experienced BKV and CMV viremia as adverse events by treatment arm.|Transplantation through Week 52|Intent-to-treat population||Participants|||Count of Participants
660494|NCT01856257|Secondary|Count of Participants With Infections Requiring Hospitalization or Systemic Therapy by Wk 52 Post-Transplant|Infections of certain types (i.e., excluding those identified in the protocol as occurring commonly in this study population) were required to be reported as a serious adverse event if they required either inpatient hospitalization or prolongation of a current hospitalization.|Transplantation through Week 52|Intent-to-treat population||Participants|||Count of Participants
660495|NCT01856257|Secondary|Count of Participants Experiencing ≥ 1 Adverse Event (AEs) or Serious Adverse Events (SAEs) by Wk 52|Adverse events were collected systematically from enrollment through Wk 52, the last study visit. Provided are numbers of participants with ≥ 1 adverse event (serious or non-serious adverse events) by treatment arm.|Enrollment through Week 52|Intent-to-treat population||Participants|||Count of Participants
660496|NCT01856257|Secondary|Count of Participants With Graft Rejection by Wk 52 Post-Transplant|The number of participants who were treated by their local physician for any type of rejection including, but not limited to cellular rejection and antibody- mediated rejection of the transplanted kidney regardless of the presence of a biopsy.|Transplantation through Week 52|Intent-to-treat population||Participants|||Count of Participants
660497|NCT01856257|Secondary|Count of Participant Deaths or Graft Loss by Wk 52 Post-Transplant|This measure counts deaths and graft loss occurring at any point post transplantation. Graft loss is defined as 90 days of dialysis dependency.|Transplantation through Week 52|Intent-to-treat population||Participants|||Count of Participants
660498|NCT01856257|Secondary|Total Daily Prescribed Pill Count|This is a measure of the total number of pills a participant was prescribed on a given day|Day 28, Day 84, Week 28, Week 36, and Week 52|Intent-to-treat population with available data||pills per day||Standard Deviation|Mean
660499|NCT01856257|Secondary|Count of Participants With Use of Lipid Lowering Medications at Baseline and Wk 28 and Wk 52 Post-Transplant|Lipid lowering medications are used in the treatment of high levels of fats (lipids), such as cholesterol in blood.|Baseline (Pre-Transplant), Week 28, and Week 52|Intent-to-treat population with available data||Participants|||Count of Participants
660500|NCT01856257|Secondary|Fasting Lipid Profile at Wk 52 Post-Transplant|"A fasting lipid profiles measures total cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride levels. These measurements are used in assessing one's risk of cardiovascular disease. Target ranges for each of these measures are provided:
Total cholesterol: 75-169 mg/dL if age ≤ 20; 100-199 mg/dL if age ≥ 21; high values indicate risk of cardiovascular disease
LDL cholesterol: <70 mg/dL for people with documented cardiovascular disease or metabolic syndrome; <100 mg/dL for people considered high risk for cardiovascular disease; <130 mg/dL for people considered low risk for cardiovascular disease; high values indicate risk of cardiovascular disease
HDL cholesterol: 40mg/dL and higher; high values indicate reduced risk of cardiovascular disease
Non-HDL cholesterol: 30 mg/dL above the target value for LDL cholesterol; high values indicate risk of cardiovascular disease and
Triglycerides: <150 mg/dL; high values indicate risk of cardiovascular disease."|Week 52|Intent-to-treat population with available data||mg/dL||Standard Deviation|Mean
660501|NCT01856257|Secondary|Fasting Lipid Profile at Wk 28 Post-Transplant|"A fasting lipid profiles measures total cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride levels. These measurements are used in assessing one's risk of cardiovascular disease. Target ranges for each of these measures are provided:
Total cholesterol: 75-169 mg/dL if age ≤20; 100-199 mg/dL if age ≥ 21; high values indicate risk of cardiovascular disease
LDL cholesterol: <70 mg/dL for people with documented cardiovascular disease or metabolic syndrome; <100 mg/dL for people considered high risk for cardiovascular disease; <130 mg/dL for people considered low risk for cardiovascular disease; high values indicate risk of cardiovascular disease
HDL cholesterol: 40mg/dL and higher; high values indicate reduced risk of cardiovascular disease
Non-HDL cholesterol: 30 mg/dL above the target value for LDL cholesterol; high values indicate risk of cardiovascular disease and
Triglycerides: <150 mg/dL; high values indicate risk of cardiovascular disease."|Week 28|Intent-to-treat population with available data||mg/dL||Standard Deviation|Mean
660502|NCT01856257|Secondary|Fasting Lipid Profile at Baseline (Pre-Transplant)|"A fasting lipid profiles measures total cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride levels. These measurements are used in assessing one's risk of cardiovascular disease. Target ranges for each of these measures are provided:
Total cholesterol: 75-169 mg/dL if age ≤20; 100-199 mg/dL if age ≥ 21; high values indicate risk of cardiovascular disease
LDL cholesterol: <70 mg/dL for people with documented cardiovascular disease or metabolic syndrome; <100 mg/dL for people considered high risk for cardiovascular disease; <130 mg/dL for people considered low risk for cardiovascular disease; high values indicate risk of cardiovascular disease
HDL cholesterol: 40mg/dL and higher; high values indicate reduced risk of cardiovascular disease
Non-HDL cholesterol: 30 mg/dL above the target value for LDL cholesterol; high values indicate risk of cardiovascular disease and
Triglycerides: <150 mg/dL; high values indicate risk of cardiovascular disease."|Baseline|Intent-to-treat population with available data||mg/dL||Standard Deviation|Mean
660503|NCT01856257|Secondary|Count of Participants With Use of Anti-hypertensive Medication at Wk 52 Post-Transplant|Anti-hypertensive medications are a class of drugs that are used to treat hypertension. The medications seek to prevent the complications of high blood pressure, such as stroke and myocardial infarction.|Week 52|Intent-to-treat population with available data||Participants|||Count of Participants
660504|NCT01856257|Secondary|Standardized Blood Pressure Measurement at Wk 52 Post-Transplant|"A blood pressure measurement consists of two numbers: the systolic and diastolic pressures. Systolic pressure measures the pressure in blood vessels when the heart beats. Diastolic pressure measures the pressure in blood vessels between beats of the heart.
Systolic measures of <120 and diastolic measures of <80 are considered normal.
Systolic measures of 120-139 and diastolic measures of 80-89 are considered at risk (or pre-hypertension).
Systolic measures of ≥140 and diastolic measures of ≥90 are considered high."|Week 52|Intent-to-treat population with available data||mmHg||Standard Deviation|Mean
660505|NCT01856257|Secondary|Hemoglobin A1c (HbA1c) Measurements Over Time|"Hemoglobin A1c (HbA1c) measures the average blood glucose levels over 8-12 weeks, thus acting as a useful long-term gauge of blood glucose control:
A value below 6.0% reflects normal levels,
6.0% to 6.4% reflects prediabetes, and
a value of ≥ 6.5% reflects diabetes."|Baseline (Pre-Transplant) and Days 28 and -84, and Weeks 28, -36, and -52 Post-Transplant|Intent-to-treat population with available data||percentage||Standard Deviation|Mean
660506|NCT01856257|Secondary|Count of Participants With Treated Diabetes Between Day 14 and Wk 52 Post-Transplant|Treated diabetes is defined as receipt of any oral medication or insulin for the treatment of diabetes for >14 days.|Day 14 through week 52|Intent-to-treat population with available data||Participants|||Count of Participants
660629|NCT01854905|Primary|Percentage of Patients in Each Category of the Dry Eye Workshop Severity (DEWS) Scale|The severity of each patient's dry eye was classified by the physician according to the DEWS scale. Categories are: mild and/or episodic, occurs under environmental stress; moderate episodic or chronic, stress or no stress; and severe frequent or constant without stress|Day 1|All enrolled patients||Percentage of Patients|||Number
660507|NCT01856257|Secondary|Count of Participants With Either New Onset Diabetes After Transplant (NODAT) or Impaired Fasting Glucose (IFG) at Week 52 Post-Transplant -Based on Criteria Specified by the ADA and WHO|"New onset diabetes is the development of diabetes post-kidney transplant. It was identified by the clinical sites caring for each participant and reported directly in the clinical database. Impaired fasting glucose (IFG) is a determination made by referencing glucose measurements obtained from a standard chemistry panel. Any fasting glucose measure that is between 110 and 125 mg/dL is classified as IFG.
Acronyms: American Diabetes Association (ADA); World Health Organization (WHO)."|Transplantation through Week 52|Intent-to-treat population with available data||Participants|||Count of Participants
660508|NCT01856257|Secondary|Count of Participants With De Novo Anti-Donor Histocompatibility Antigen (HLA) Antibodies at Wk 52 Post-Transplant|"The presence of antibodies reactive to Histocompatibility Antigen (HLA) molecules expressed on the renal allograft have been associated with both acute and chronic injury to the transplanted kidney. The development of de novo anti donor HLA antibodies may mean a person is more likely to reject the graft.
No data available."|Week 52|No analysis due to no available data. Data were not reported from the central laboratory and, therefore, unable to be summarized.|||||
660509|NCT01856257|Secondary|Type of Treatment for Detected Graft Rejection|"Upon having a biopsy performed, persons often receive treatment for rejection based on the results of the biopsy, which may or may not have shown signs of rejection. Details of treatment are presented here for rejection. Acronyms and abbreviations are defined below.
ATG=Thymoglobulin"|Transplantation through Week 52|Intent-to-treat population||Biopsy|||Number
660510|NCT01856257|Secondary|Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies|"Upon having a biopsy performed, persons often receive treatment for rejection based on the results of the biopsy, which may or may not have shown signs of rejection. Details of local biopsy findings are presented here for rejection. Acronyms and abbreviations are defined as follows:
ACR= Acute T-Cell Mediated rejection
AMR= Acute Antibody-mediated rejection
Chr. AMR=Chronic Antibody Mediated Rejection
Gd.=Grade
IFTA=Interstitial Fibrosis and Tubular Atrophy"|Transplantation through Week 52|Intent-to-treat population||Biopsy|||Number
660511|NCT01856257|Secondary|Count of Participants With Antibody Mediated Rejection by Wk 52 Post-Transplant|Antibody mediated rejection is defined by diffusely positive staining for C4d, presence of circulating anti-donor antibodies, and morphologic evidence of acute tissue injury and was determined by local pathology.|Transplantation through Week 52|Intent-to-treat population||Participants|||Count of Participants
660512|NCT01856257|Secondary|Count of Participants by Severity of First Acute Cellular Rejection by Wk 52 Post-Transplant|Acute cellular rejection occurs when lesions at the site of the graft characteristically are infiltrated with large numbers of lymphocytes and macrophages that cause tissue damage. Acute cellular rejection for this endpoint is defined as a grade equal to or greater than IA by Banff 2007 criteria as determined by local pathology. Severity is graded as IA, IB, IIA, IIB, or III, with IA being the mildest form of cellular rejection and III being the most severe form of cellular rejection. Originally it was 2 endpoints but all participants’ highest grade was also their first grade so only reporting their first grade.|Transplantation through Week 52|Intent-to-treat population||Participants|||Count of Participants
660513|NCT01856257|Secondary|Count of Participants With Acute Cellular Rejection Grade ≥ IA Defined by Banff 2007 Criteria By Wk 52 Post-Transplant|Acute cellular rejection occurs when lesions at the site of the graft characteristically are infiltrated with large numbers of lymphocytes and macrophages that cause tissue damage. Acute cellular rejection for this endpoint is defined as a grade equal to or greater than IA by Banff 2007 criteria as determined by local pathology.|Transplantation through Week 52|Intent-to-treat population||Participants|||Count of Participants
660514|NCT01856257|Secondary|Count of Participants With Delayed Graft Function at Wk 52 Post-Transplant|Delayed grafted function is defined as dialysis in the first week on one or more occasions for any indication other than the treatment of acute hyperkalemia in the setting of otherwise acceptable renal function.|Transplantation through Week 52|Intent-to-treat population||Participants|||Count of Participants
660515|NCT01856257|Secondary|The Slope of eGFR by CKD-EPI Over Time Based on Serum Creatinine Post-Transplant|"The estimated Glomerular Filtration Rate (eGFR) was calculated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI):
A score of ≥ 90 means kidney function is normal.
A score between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease.
Scores between 30 and 59 indicates moderately reduced kidney function.
Scores between 15 and 29 indicate severely reduced kidney function.
Scores below 15 indicate very severe or endstage kidney failure.
An estimate of the slope, or change over time, in eGFR was produced using standard statistical linear modeling procedures. The estimate was then re-scaled so that it could be interpreted as a change in eGFR per month. Positive numbers indicate increasing kidney function.
Larger numbers indicate greater change in kidney function."|Day 28 through Week 52 Post-Transplant|Intent-to-treat population with available data||eGFR change over time (by month)||Standard Deviation|Mean
660516|NCT01856257|Secondary|Mean Calculated eGFR Using MDRD 4 Variable Model at Wk 52 Post-Transplant|"The estimated Glomerular Filtration Rate (eGFR) was calculated using the Modification of Diet in Renal Disease equation (MDRD):
A score of ≥ 90 means kidney function is normal.
A score between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease.
Scores between 30 and 59 indicates moderately reduced kidney function.
Scores between 15 and 29 indicate severely reduced kidney function.
Scores below 15 indicate severe or endstage kidney failure."|Week 52|Intent-to-treat population with available data||mL/min/1.73m^2||Standard Deviation|Mean
660517|NCT01856257|Secondary|Count of Participants With Defined CKD Stage 4 or 5 at Wk 52 Post-Transplant|"The stages of Chronic Kidney Disease (CKD) are defined using the participant’s GFR value:
Stage 1 if GFR value is ≥ 90 (kidney function is normal)
Stage 2 if 60 ≤ GFR < 90 (mildly reduced kidney function, pointing to kidney disease)
Stage 3A if 45 <= GFR < 60*
Stage 3B if 30 <= GFR < 45*
Stage 4 if 15 ≤ GFR < 30 (severely reduced kidney function)
Stage 5 if GFR < 15 (severe or end stage kidney failure).
Stages 3A abd 3B indicate moderately reduced kidney function.*"|Week 52|Intent-to-treat population||Participants|||Count of Participants
660579|NCT01855945|Secondary|GMR in Subjects (3 to ≥ 61 Years of Age) of Post-vaccination Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine.|GMR of post-vaccination versus pre-vaccination HI GMTs following vaccination with H3N2 monovalent vaccine is reported across subjects with age groups 3 to ≥ 61 years.|Day 22/Day 1, Day 43/Day 1, Day183/ Day 1, Day 366/Day 1|Analysis was done on Full Analysis Set.||Ratios||95% Confidence Interval|Geometric Mean
660518|NCT01856257|Secondary|Count of Participants by CKD Stage at Wk 52|"The stages of Chronic Kidney Disease are defined using the participant’s GFR value:
Stage 1 if GFR value is ≥90 ( kidney function is normal)
Stage 2 if 60 ≤ GFR < 90 (mildly reduced kidney function, pointing to kidney disease)
Stage 3A if 45 ≤ GFR < 60*
Stage 3B if 30 ≤ GFR < 45*
Stage 4 if 15 ≤ GFR < 30 (severely reduced kidney function)
Stage 5 if GFR < 15 (severe or end stage kidney failure).
Stages 3A and 3B indicate moderately reduced kidney function.*"|Week 52|Intent-to-treat population||Participants|||Count of Participants
660519|NCT01856257|Secondary|Count of Participants With eGFR < 60 mL/Min/1.73 m^2 Measured by CKD-EPI at Wk 52 Post-Transplant|"eGFR was calculated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI):
A score of ≥90 means kidney function is normal.
A score between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease.
Scores between 30 and 59 indicates moderately reduced kidney function.
Scores between 15 and 29 indicate severely reduced kidney function.
Scores below 15 indicate very severe or end stage kidney failure."|Week 52|Intent-to-treat population||Participants|||Count of Participants
660520|NCT01856257|Secondary|Count of Participants With Biopsy Proven Acute Rejection By Wk 52 Post-Transplant|Biopsy proven acute rejection definition: histologic evidence of a Banff grade of ≥1A per local pathologist.|Transplantation through Week 52|Intent-to-treat population||Participants|||Count of Participants
660521|NCT01856257|Primary|Mean Estimated Glomerular Filtration Rate (eGFR) Calculated for Each Treatment Group Using the CKD-EPI Equation at Wk 52 Post-Transplant|"eGFR was calculated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI):
A score of ≥90 means kidney function is normal.
A score between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease.
Scores between 30 and 59 indicates moderately reduced kidney function.
Scores between 15 and 29 indicate severely reduced kidney function.
Scores below 15 indicate very severe or end stage kidney failure."|Week 52|Intent-to-treat population with available data at week 52||mL/min/1.73m^2||Standard Deviation|Mean
660522|NCT01855997|Other Pre-specified|Number of Participants With HBsAg Clearance ≥24 Weeks Post-Treatment in Non-CN Population|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.|Single blood sample ≥24 weeks post-treatment|Non-CN Population; the analysis only included a subset of participants who provided evaluable data.||participants|||Number
660523|NCT01855997|Other Pre-specified|Number of Participants With HBsAg Clearance ≥24 Weeks Post-Treatment in CN Population|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.|Single blood sample ≥24 weeks post-treatment|CN Population.||participants|||Number
660524|NCT01855997|Other Pre-specified|Number of Participants With HBsAg Clearance ≥24 Weeks Post-Treatment|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.|Single blood sample ≥24 weeks post-treatment|GT Population; the analysis only included a subset of participants who provided evaluable data.||participants|||Number
660525|NCT01855997|Other Pre-specified|Number of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined endpoint in this outcome measure.|Single blood sample ≥24 weeks post-treatment|Non-CN Population.||participants|||Number
660526|NCT01855997|Other Pre-specified|Number of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined endpoint in this outcome measure.|Single blood sample ≥24 weeks post-treatment|CN Population.||participants|||Number
660527|NCT01855997|Other Pre-specified|Number of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined endpoint in this outcome measure.|Single blood sample ≥24 weeks post-treatment|GT Population.||participants|||Number
660528|NCT01855997|Other Pre-specified|Number of Participants With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL.|Single blood sample ≥24 weeks post-treatment|Non-CN Population.||participants|||Number
660529|NCT01855997|Other Pre-specified|Number of Participants With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL.|Single blood sample ≥24 weeks post-treatment|CN Population; the analysis only included a subset of participants who provided evaluable data.||participants|||Number
660630|NCT01854697|Secondary|Percentage of Participants With Sustained Virologic Response 24 Weeks After Treatment (SVR24)|The percentage of participants with sustained virologic response (plasma HCV RNA level < LLOQ) 24 weeks after the last dose of study drug.|24 weeks after the last actual dose of active study drug|Intent-to-treat Population: all randomized participants who received at least 1 dose of study drug.||percentage of participants|||Number
660530|NCT01855997|Other Pre-specified|Number of Participants With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL.|Single blood sample ≥24 weeks post-treatment|GT Population.||participants|||Number
660531|NCT01855997|Other Pre-specified|Number of Participants With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Non-CN Population|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.|Single blood sample ≥24 weeks post-treatment|HBeAg-Negative Non-CN Population.||participants|||Number
660532|NCT01855997|Other Pre-specified|Number of Participants With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative CN Population|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.|Single blood sample ≥24 weeks post-treatment|HBeAg-Negative CN Population.||participants|||Number
660533|NCT01855997|Other Pre-specified|Number of Participants With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.|Single blood sample ≥24 weeks post-treatment|HBeAg-Negative Population.||participants|||Number
660534|NCT01855997|Other Pre-specified|Number of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Non-CN Population|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined endpoint in this outcome measure.|Single blood sample ≥24 weeks post-treatment|HBeAg-Positive Non-CN Population.||participants|||Number
660535|NCT01855997|Other Pre-specified|Number of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined endpoint in this outcome measure.|Single blood sample ≥24 weeks post-treatment|HBeAg-Positive CN Population.||participants|||Number
660536|NCT01855997|Other Pre-specified|Number of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined endpoint in this outcome measure.|Single blood sample ≥24 weeks post-treatment|HBeAg-Positive Population.||participants|||Number
660537|NCT01855997|Other Pre-specified|Number of Participants With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Non-CN Population|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.|Single blood sample ≥24 weeks post-treatment|HBeAg-Positive Non-CN Population: All HBeAg-positive participants whose genetic data passed a protocol-specified quality check and did not share common East Asian genetic background as compared to HapMap version 3.0 reference individuals.||participants|||Number
660538|NCT01855997|Other Pre-specified|Number of Participants With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.|Single blood sample ≥24 weeks post-treatment|HBeAg-Positive CN Population.||participants|||Number
660539|NCT01855997|Other Pre-specified|Number of Participants With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.|Single blood sample ≥24 weeks post-treatment|HBeAg-Positive Population.||participants|||Number
660540|NCT01855997|Primary|SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment: Dominant Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs6592052) was included in the analysis.|Single blood sample ≥24 weeks post-treatment|GT Population; the analysis only included a subset of participants who provided evaluable data.||beta coefficient|||Number
660580|NCT01855945|Primary|Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine.|The percentages of subjects (3 to ≥ 65 years of age) achieving HI titers ≥1:40 against H3N2 homologous strain at baseline (Day 1) and three weeks after receiving first (Day 22) and second (Day 43) vaccination are reported.|Day 1, Day 22, Day 43 post vaccination|Analysis was done on Full Analysis Set.||Percentages of Subjects||95% Confidence Interval|Number
660541|NCT01855997|Primary|SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment: Additive Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|GT Population; the analysis only included a subset of participants who provided evaluable data.||beta coefficient|||Number
660542|NCT01855997|Primary|SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment in CN Population: Dominant Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs7549785) was included in the analysis.|Single blood sample ≥24 weeks post-treatment|CN Population.||beta coefficient|||Number
660543|NCT01855997|Primary|SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment in CN Population: Additive Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs7549785) was included in the analysis.|Single blood sample ≥24 weeks post-treatment|CN Population.||beta coefficient|||Number
660544|NCT01855997|Primary|SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment in Non-CN Population: Dominant Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs12992677) was included in the analysis.|Single blood sample ≥24 weeks post-treatment|Non-CN Population; the analysis only included a subset of participants who provided evaluable data.||beta coefficient|||Number
660545|NCT01855997|Primary|SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment in Non-CN Population: Additive Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs12992677) was included in the analysis.|Single blood sample ≥24 weeks post-treatment|Non-CN Population; the analysis only included a subset of participants who provided evaluable data.||beta coefficient|||Number
660546|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Dominant Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|GT Population.||beta coefficient|||Number
660547|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Additive Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|GT Population.||beta coefficient|||Number
660548|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Dominant Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|CN Population; the analysis only included a subset of participants who provided evaluable data.||beta coefficient|||Number
660549|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Additive Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|CN Population; the analysis only included a subset of participants who provided evaluable data.||beta coefficient|||Number
660550|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population: Dominant Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|Non-CN Population.||beta coefficient|||Number
660551|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population: Additive Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|Non-CN Population.||beta coefficient|||Number
660552|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Dominant Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|GT Population.||beta coefficient|||Number
660553|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Additive Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|Genetic Data Quality Check (GT) Population: All participants, regardless of HBeAg status, whose genetic data passed a protocol-specified quality check.||beta coefficient|||Number
660554|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Dominant Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|CN Population; the analysis only included a subset of participants who provided evaluable data.||beta coefficient|||Number
660555|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Additive Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|CN Population: All participants, regardless of HBeAg status, whose genetic data passed a protocol-specified quality check and shared common East Asian genetic background as compared to HapMap version 3.0 reference individuals; the analysis only included a subset of participants who provided evaluable data.||beta coefficient|||Number
660556|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population: Dominant Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs17037122) was included in the analysis.|Single blood sample ≥24 weeks post-treatment|Non-CN Population.||beta coefficient|||Number
660557|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population: Additive Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|Non-CN Population: All participants, regardless of HBeAg status, whose genetic data passed a protocol-specified quality check and did not share common East Asian genetic background as compared to HapMap version 3.0 reference individuals.||beta coefficient|||Number
660558|NCT01855997|Primary|SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population: Dominant Model|GWAS approach was used to evaluate the association of SNPs with treatment response. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|HBeAg-Negative Population.||beta coefficient|||Number
660559|NCT01855997|Primary|SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population: Additive Model|GWAS approach was used to evaluate the association of SNPs with treatment response. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|HBeAg-Negative Population: All HBeAg-negative participants whose genetic data passed a protocol-specified quality check.||beta coefficient|||Number
660560|NCT01855997|Primary|SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative CN Population: Dominant Model|GWAS approach was used to evaluate the association of SNPs with treatment response. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|HBeAg-Negative CN Population.||beta coefficient|||Number
660561|NCT01855997|Primary|SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative CN Population: Additive Model|GWAS approach was used to evaluate the association of SNPs with treatment response. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs2464266) was included in the analysis.|Single blood sample ≥24 weeks post-treatment|HBeAg-Negative CN Population: All HBeAg-negative participants whose genetic data passed a protocol-specified quality check and shared common East Asian genetic background as compared to HapMap version 3.0 reference individuals.||beta coefficient|||Number
660562|NCT01855997|Primary|SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Non-CN Population: Dominant Model|GWAS approach was used to evaluate the association of SNPs with treatment response. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs17037122) was included in the analysis.|Single blood sample ≥24 weeks post-treatment|HBeAg-Negative Non-CN Population.||beta coefficient|||Number
660581|NCT01855945|Secondary|Percentages of Subjects (3 to ≥ 61 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine.|The percentages of subjects achieving HI titers ≥1:40 against H3N2 homologous strain at three weeks after receiving first (day 22) and second (day 43) vaccination, is reported across age groups of 3 to ≥ 61 years.|Day 1, Day 22, Day 43 post vaccination|Analysis was done on Full Analysis Set.||Percentages of Subjects||95% Confidence Interval|Number
660563|NCT01855997|Primary|SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Non-East Asian (Non-CN) Population: Additive Model|GWAS approach was used to evaluate the association of SNPs with treatment response. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs17037122) was included in the analysis.|Single blood sample ≥24 weeks post-treatment|HBeAg-Negative Non-CN Population: All HBeAg-negative participants whose genetic data passed a protocol-specified quality check and did not share common East Asian genetic background as compared to HapMap version 3.0 reference individuals.||beta coefficient|||Number
660564|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Dominant Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|HBeAg-Positive Population.||beta coefficient|||Number
660565|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Additive Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|HBeAg-Positive Population.||beta coefficient|||Number
660566|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Dominant Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|HBeAg-Positive CN Population.||beta coefficient|||Number
660567|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion Plus Undetectable Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Additive Model|GWAS approach was used to evaluate association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as HBV DNA level below the lower limit of detection (LLD) of 2000 international units per milliliter (IU/mL). HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|HBeAg-Positive CN Population.||beta coefficient|||Number
660568|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Dominant Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|HBeAg-Positive Population.||beta coefficient|||Number
660569|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Additive Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|HBeAg-Positive Population: All HBeAg-positive participants whose genetic data passed a protocol-specified quality check.||beta coefficient|||Number
662327|NCT01824446|Primary|Time to Maximum Plasma Concentration (Tmax) of Radiolabelled SSP-004184|Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached.|Up to 288 hours post-dose|PAS||hours||Full Range|Median
660570|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Dominant Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|HBeAg-Positive CN Population.||beta coefficient|||Number
660571|NCT01855997|Primary|Single Nucleotide Polymorphisms (SNPs) Associated With HBeAg Seroconversion or Hepatitis B Surface Antigen (HBsAg) Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive East Asian (CN) Population: Additive Model|Genome-wide association study (GWAS) approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of the antibody to HBeAg (anti-HBe). HBsAg clearance was defined as the loss of HBsAg, with or without detection of the antibody to HBsAg (anti-HBs). Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|HBeAg-Positive CN Population: All HBeAg-positive participants whose genetic data passed a protocol-specified quality check and shared common East Asian genetic background as compared to haplotype map (HapMap) version 3.0 reference individuals.||beta coefficient|||Number
660572|NCT01855958|Primary|Conditioned Pain Modulation (CPM) After Intervention.|"PPT during cold water immersion (PPT+CPM): By measuring PPT during cold water immersion, we evaluated the degree to which pain perception is modulated by conditioned pain modulation (CPM) following the presentation of an initial heterotopic noxious stimulus. Subjects immersed their left hands into cold water (zero to 1°C) for 1 minute. During the last 30 seconds of cold-water immersion, the PPT procedure was administered at the right forearm. The temperature was held constant across during the experiment for each subject.
# Below the data after intervention."|Before and within one hour after intervention.|||Kgf / cm2||Standard Deviation|Mean
660573|NCT01855958|Secondary|Cortical Silent Period (CSP) After Intervention.|"To determine the cortical silent period (CSP), subjects were instructed to squeeze the dynamometer using their fingers at 20% of maximal force when a single pulse stimulus (130% rMT) was applied. The result was the average of five consecutive measurements. The CSP was determined by the interval between the stimulus and the motor response elicited in the subject.
# Below the data after intervention."|Evaluated before and within one hour after intervention.|||ms (milliseconds).||Standard Deviation|Mean
660574|NCT01855958|Secondary|Intracortical Facilitation (ICF) After Intervention.|"ICF was evaluated using an inter-stimuli intervals (ISIs) of 12 ms with paired-pulse and similar parameters for the conditioning and test stimuli. After a randomized protocol, thirty stimuli were assessed using a 2ms interval (ICI), a 12ms interval (ICF) and test-only trials (MEP). The resulting MEP amplitude was converted into the mean amplitude, and paired-pulse parameters were expressed as the amount of inhibition or facilitation. The calculation result of ICF was done by the ratio of the mean ICF by the mean MEP.
# Below the data after intervention."|Before and within one hour after intervention.|||ratio of amplitude (mV).||Standard Deviation|Mean
660575|NCT01855958|Primary|Motor Evoked Potential (MEP) After Intervention.|"Cortical excitability was assessed using a MagPro X100 (MagVenture Company, Lucernemarken, Denmark) and a figure-of-8 coil centered over the left motor cortex (M1). Subjects were seated in a comfortable reclining chair with their arms and hands lying relaxed on the armrests. The investigators measured the resting motor threshold (rMT) of the right first dorsal interosseous (FDI) muscle. The MEPs were recorded by surface electromyography (EMG) using Ag–AgCl cup electrodes in a belly tendon montage. Resting motor threshold (rMT) was deﬁned as the stimulus intensity at which peak-to-peak MEP amplitude of 50 µV (microvolts) was obtained in at least 5 of 10 consecutive trials.
MEP was deﬁned as approximately 130% of the rMT or the stimulus intensity at which peak-to-peak MEP amplitude of at least 1 mV was obtained in 10 consecutive trials. The result of the MEP was the average of 10 curves (unconditioned MEP).
# Below the data after intervention."|Before and within one hour after intervention.|||mV (millivolts).||Standard Deviation|Mean
660576|NCT01855958|Primary|Pain Pressure Threshold (PPT) After Intervention..|"PPT (alone): The patient was instructed to verbally report the perception of pain onset. The investigator assessed PPT using an electronic algometer (J Tech Medical Industries, USA). The device had a 1-cm2 hard-rubber probe, which was applied over structures at L1- L5 dermatome at the knee and at the contralateral forearm. The average values of PPT in kgf/cm2 for three successive readings taken at intervals of 3-5 min were used as the outcomes.
# Below, the data after intervention."|Before and within one hour after intervention.|||Kgf / cm2||Standard Deviation|Mean
660577|NCT01855958|Secondary|Pain Intensity After Intervention.|"The intensity of pain was measured by a 10-cm VAS. VAS scores ranged from no pain (zero) to the worst possible pain possible (10 cm). The pain score on VAS during the last 24 hours was used to classify the subjects into two groups: (1) absence of pain or mild pain (scores equal to or lower than 4 cm) and (2) moderate, intense, or worst possible pain (scores higher than 4 cm).
# Below the data after intervention."|Evaluated within twenty four hours before and within one hour after the intervention.|||cm ( mean).||Standard Deviation|Mean
660578|NCT01855958|Secondary|Intracortical Inhibition (ICI) After Intervention.|"ICI was evaluated using inter-stimuli intervals (ISIs) of 2 ms with paired-pulse stimulation. The subthreshold stimulus was set at 80% of rMT (conditioning stimulus) , and the suprathreshold test stimulus was set at 130% of rMT. After a randomized protocol, thirty stimuli were assessed using a 2ms interval (ICI), a 12ms interval (ICF) and test-only trials (MEPs). The resulting MEP amplitude was converted into the mean amplitude, and paired-pulse parameters were expressed as the amount of inhibition or facilitation. The calculation result of ICI was done by the ratio of the mean ICI by the mean MEP.
# Below the data after intervention."|Evaluated in one day. The cortical excitability before and within an hour after intervention.|||ratio of amplitude (mV).||Standard Deviation|Mean
661432|NCT01840943|Secondary|Time to Reach the Maximum Plasma Concentration of CAELYX||0 hour, 30 minutes, 90 minutes, 2 hours, 4 hours, 8 hours, 12 hours, Day 2, Day 3, Day 5, Day 8, and Day 11 for Cycle 1 and Cycle 2|Data was not collected for this outcome measure as the study was early terminated.|||||
660582|NCT01855945|Secondary|Percentages of Subjects (3 to ≥ 61 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine.|"The percentage of subjects achieving seroconversion or significant increase for HI antibody titers at three weeks after receiving first (Day 22) and second (Day 43) vaccination is reported, across age groups of 3 to ≥61 years.
Seroconversion is defined as HI titer ≥1:40 for subjects negative at baseline (HI titer <1:10); or a minimum 4-fold increase in HI titer for subjects positive at baseline (HI titer ≥1:10) on Day 22 and Day 43."|Day 22, Day 43 post vaccination|Analysis was done on Full Analysis Set.||Percentages of Subjects||95% Confidence Interval|Number
660583|NCT01855945|Secondary|Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine.|The percentages of subjects (3 to ≥ 65 years of age) demonstrating HI titers ≥1:40 against H3N2 homologous strain on Day 183 and Day 366 post vaccination.|Day 183 and Day 366 post vaccination|Analysis was done on the full analysis set.||Percentages of Subjects||95% Confidence Interval|Number
660584|NCT01855945|Secondary|Geometric Mean Ratio of Subjects (3 to ≥ 65 Years of Age) Post Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine.|The geometric mean ratio (GMR) of post versus pre-vaccination HI antibody titers against H3N2 homologous strain following vaccination as compared to baseline titers are reported for after first (Day 22/Day 1) and second (Day 43/Day 1) vaccination and for persisting titers at six months (Day 183/Day1) and one year (Day 366/Day 1) is reported across subjects with age groups 3 to ≥ 65 years.|Day 22/Day 1, Day 43/Day 1, Day 183/Day 1, Day 366/Day 1|Analysis was done on Full Analysis Set.||Ratios||95% Confidence Interval|Geometric Mean
660585|NCT01855945|Secondary|Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age).|The HI antibody titers against H3N2 homologous strain at baseline (Day 1), three weeks after first (Day 22) and second (Day 43) vaccination and persisting titers at six months (Day 183) and one year (Day 366) after vaccination are reported in terms of GMTs is reported across subjects with age groups 3 to ≥ 65 years.|Day 1, Day 22, Day 43, Day 183 and Day 366 post vaccination|Analysis was done on Full Analysis Set.||Titers||95% Confidence Interval|Geometric Mean
660586|NCT01855945|Primary|Percentages of Subjects (3 to ≥ 65 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition (HI) Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine.|"The percentages of subjects (3 to ≥ 65 years of age) achieving seroconversion or significant increase in HI antibody titers against H3N2 homologous strain, three weeks after receiving first (Day 22) and second (Day 43) vaccination are reported.
Seroconversion is defined as HI titer ≥1:40 for subjects negative at baseline (HI titer <1:10); or a minimum 4-fold increase in HI titer for subjects positive at baseline (HI titer ≥1:10) on Day 22 and Day 43."|Day 22, Day 43 post vaccination|Analysis was done on Full Analysis Set.||Percentages of Subjects||95% Confidence Interval|Number
660587|NCT01855945|Primary|Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine.|"The number of subjects reporting any unsolicited adverse events (AEs) from day 1 through day 21 after last vaccination within each vaccine group are reported.
The number of subjects reporting any serious adverse events (SAEs), AEs leading to withdrawal from the study, medically attended AEs, AE of special interest (AESI), new onset chronic disease (NOCDs) from day 1 through day 366, after receiving with H3N2 monovalent vaccine are reported."|Day 1 through Day 366|Analysis was done on unsolicited safety dataset i.e. all subjects in the exposed population who have post-vaccination unsolicited adverse event records.||Number of subjects|||Number
660588|NCT01855945|Primary|Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine.|Safety and tolerability of H3N2 monovalent vaccine was assessed in terms of the number of subjects (≥ 65 years of age) reporting solicited local and systemic adverse events and other adverse events after each vaccination.|Day 1 through Day 7 after each vaccination|Analysis was done on Solicited Safety Set.||Number of Subjects|||Number
660589|NCT01855945|Primary|Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine.|Safety and tolerability of H3N2 monovalent vaccine was assessed in terms of the number of subjects (18 to < 65 years of age) reporting solicited local and systemic adverse events and other adverse events after each vaccination.|Day 1 through Day 7 after each vaccination|Analysis was done on Solicited Safety Set.||Number of Subjects|||Number
660590|NCT01855945|Primary|Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine.|Safety and tolerability of H3N2 monovalent vaccine was assessed in terms of the number of subjects (9 to <18 years of age) reporting solicited local and systemic adverse events and other adverse events after each vaccination.|Day 1 through Day 7 after each vaccination|Analysis was done on Solicited Safety Set.||Number of Subjects|||Number
660591|NCT01855945|Primary|Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine.|Safety and tolerability of H3N2 monovalent vaccine was assessed in terms of the number of subjects (3 to <9 years of age) reporting solicited local and systemic adverse events and other adverse events after each vaccination.|Day 1 through Day 7 after each vaccination|Analysis was done on Solicited Safety Set.||Number of Subjects|||Number
660592|NCT01855919|Secondary|Percentage of Participants With Fall Events in Fall Questionnaire|Participants evaluated their experience with and details of falls which were recorded. Percentage = (number of participants with fall events) /(total in treatment group) * 100.|Baseline through Week 14|All randomized participants who received at least 1 dose of study drug.||percentage of participants|||Number
660593|NCT01855919|Secondary|Number of Participants With Suicidal Thoughts And Behaviors During Study [Columbia Suicide Severity Rating Scale (C-SSRS)]|"C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior is defined as a yes answer to any 1 of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation is defined as a yes answer to any 1 of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation."|Baseline through Week 14|All randomized participants who received at least 1 dose of study drug, responded no at baseline to the suicide related questionnaire and had data at post-treatment for each question.||percentage of participants|||Number
663862|NCT01797029|Primary|Percentage of Participants With Symptomatic, Laboratory-confirmed Influenza Virus Infection (Vaccine-matched Strains).||Through 7 to 9 months post-vaccination|||percentage of participants|||Number
660594|NCT01855919|Secondary|Change From Baseline in Work Productivity and Activity Impairment (WPAI) Instrument to Week 14|WPAI is a self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities, and yields 4 types of scores: Absenteeism (work time missed)=Question (Q)2/(Q2+4))*100); Presenteeism (impairment at work/reduced on-the-job effectiveness)=(Q5/10)*100); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism)=(Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))x(Q5/10)])*100); and Activity Impairment=(Q6/10)*100. Scores range from 0 to 1 for each of the above 4 types; higher scores indicate greater impairment. LS means calculated using ANCOVA adjusted for treatment, as fixed effect and baseline as covariate.|Baseline, Week 14|FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) scores. LOCF was used.||hours||Standard Error|Least Squares Mean
660595|NCT01855919|Secondary|Change From Baseline in European Quality of Life Questionnaire-5 Dimension (EQ-5D) to Week 14|The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a 3 level scale (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the Japan population-based algorithm ranging from -0.111 to 1.0, with higher scores indicating better quality of life. LS means calculated using ANCOVA adjusted for treatment, as fixed effect and baseline as covariate.|Baseline, Week 14|FAS: All randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-dose BPI pain severity (average pain) scores. LOCF.||units on a scale||Standard Error|Least Squares Mean
660596|NCT01855919|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) to Week 14|SF-36 Health Status Survey is a generic, health-related scale assessing participant’s quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. LS means calculated using ANCOVA adjusted for treatment, as fixed effect and baseline as covariate.|Baseline, Week 14|FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) scores. LOCF was used.||units on a scale||Standard Error|Least Squares Mean
660597|NCT01855919|Secondary|Change From Baseline in Beck Depression Inventory-II (BDI-II) to Week 14|BDI-II is a 21-question multiple-choice self-reported inventory about depressive symptoms (sadness, pessimism, past failure, loss of pleasure, guilty feelings, punishment feelings, self-dislike, self-criticalness, suicidal thoughts or wishes, crying, agitation, loss of interest, indecisiveness, worthlessness, loss of energy, changes in sleeping patterns, irritability, changes in appetite, concentration difficulties, tiredness or fatigue, and loss of interest in sex). The scores for each item range from 0 (best) to 3 (worst) with possible total scores of 0 to 63, where higher total scores indicate more severe depressive symptoms. LS means calculated using ANCOVA adjusted for treatment, as fixed effect and baseline as covariate.|Baseline, Week 14|FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) scores. LOCF was used.||units on a scale||Standard Error|Least Squares Mean
660598|NCT01855919|Secondary|Change From Baseline in Clinical Global Impression of Severity (CGI-Severity) to Week 14|CSI-S measures severity of illness at the time of assessment compared with start of treatment with scores ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). LS means calculated using MMRM adjusted for treatment, visit, interaction between treatment and visit as fixed effects and baseline value as covariate.|Baseline, Week 14|FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) scores.||units on a scale||Standard Error|Least Squares Mean
660599|NCT01855919|Secondary|Percentage of Participants With Sustained Pain Reduction in BPI Average Pain Score|Pain severity was measured using an 11 point BPI scale from 0 (no pain) to 10(worst pain) to determine average pain in the past 24 hours (average pain). Participants were considered to have sustained pain reduction of ≥30% in the BPI-severity score (average pain) at the time of final evaluation and at least 1 other time point prior to the time of final evaluation compared with baseline, and a reduction of ≥20% from baseline sustained at all evaluation time points between that period. Percentage of participants = (number of participants with sustained pain reduction / total number of participants in treatment group) * 100.|Baseline through Week 14|FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) scores.||percentage of participants|||Number
660600|NCT01855919|Secondary|Percentage of Participants With Reduction of ≥30% and ≥50% in BPI Average Pain Score at Week 14|Pain severity was measured using an 11 point BPI scale from 0 (no pain) to 10 (worst pain) to determine average pain in the past 24 hours (average pain). A 30% (or 50%) improvement was defined as a ≥30% (or ≥50%) reduction in BPI pain severity from baseline to endpoint. Percentage of participants = (number of participants with ≥30% or ≥50% pain reduction / total number of participants in treatment group) * 100.|Baseline, Week 14|FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) scores. LOCF was used.||percentage of participants|||Number
660601|NCT01855919|Secondary|Change From Baseline in Weekly Mean of 24 Hour Average Pain and Worst Daily Pain Severity Scores to Week 14|24-hour average pain severity scores were recorded daily on an 11-point Likert scale, an ordinal scale, with scores ranging from 0 (no pain) to 10 (worst possible pain). The 11-point Likert scale was also used for assessment of average pain and worst pain within 24-hours. For the analysis, weekly mean was calculated. LS means calculated using MMRM adjusted for treatment, week, interaction between treatment and week as fixed effects and baseline value as covariate.|Baseline, Week 14|FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) scores.||units on a scale||Standard Error|Least Squares Mean
660631|NCT01854697|Secondary|Percentage of Participants With Post-treatment Relapse|Hepatitis C virus (HCV) ribonucleic acid (RNA) confirmed greater than or equal to the lower limit of quantification (LLOQ) between the end of treatment and 24 weeks post treatment among participants completing treatment and with HCV RNA less than the LLOQ at the end of treatment.|Within 24 weeks post treatment|Intent-to-treat Population: all randomized participants who received at least 1 dose of study drug and had sustained virologic response at Week 24 (SVR24).||percentage of participants|||Number
660602|NCT01855919|Secondary|Change From Baseline in BPI Pain Severity Items (BPI-S) and Interference Items (BPI-I) Scores to Week 14|BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. Severity scores range from: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores range from: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference is defined as the average of non-missing scores of individual interference items. Higher scores indicated worsening of pain. LS means calculated using MMRM adjusted for treatment, visit, interaction between treatment and visit as fixed effects and baseline value as covariate.|Baseline, Week 14|FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) scores.||units on a scale||Standard Error|Least Squares Mean
660603|NCT01855919|Secondary|Change From Baseline in Roland Morris Disability Questionnaire (RMDQ-24) to Week 14|The RMDQ-24 is a health status measure completed by participants to assess physical disability due to low back pain. Participants answered 24 questions about impairment of daily living activities (standing, walking, sitting, wearing clothes, working, etc.) resulting from low back pain. The number of statements marked was summed by the clinician for a total score. The total scores range from 0 (no disability) to 24 (severe disability). LS means calculated using analysis of covariance (ANCOVA) with treatment group as a fixed effect, and baseline value as a covariate.|Baseline, Week 14|FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) scores. The last observation carried forward (LOCF) was used.||units on a scale||Standard Error|Least Squares Mean
660604|NCT01855919|Secondary|Patient Global Impression of Improvement (PGI-I) at Week 14|PGI-I measures a participant's perception of improvement at the time of assessment compared with the start of treatment. Score ranges from 1 (very much better) to 7 (very much worse). LS means calculated using MMRM adjusted for treatment, visit, interaction between treatment and visit as fixed effects and baseline value as covariate.|Week 14|FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) scores.||units on a scale||Standard Error|Least Squares Mean
660605|NCT01855919|Primary|Change From Baseline to Week 14 in Brief Pain Inventory (BPI) 24-Hour Average Pain Severity Item|BPI is a self-reported scale that measures the severity of pain based on the average pain during the past 24-hours. The severity scores ranged from 0 (no pain) to 10 (pain as severe as you can imagine). Higher scores indicated worsening of pain. Least squares (LS) means calculated using mixed model repeating measure (MMRM) adjusted for treatment, visit, interaction between treatment and visit as fixed effects and baseline value as covariate.|Baseline, Week 14|FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) scores.||units on a scale||Standard Error|Least Squares Mean
660606|NCT01855074|Secondary|Extrapyramidal Symptom Rating Scale (ESRS) Score|An ESRS scale is used to assess the extrapyramidal symptoms attributable to antipsychotics. It consists of 8 items to assess individual symptoms and each item is assessed from 0 (none, absent) to 4 (severe). The total score is the sum of the 8 item scores, for a total range of 0 (normal) to 32 severe). The items for the assessment of individual symptoms are classified into 4 categories of parkinsonism, akathisia, dystonia and dyskinesia.|Baseline and Week 26|Safety set (SS) population (N=79) included all participants who received at least 1 dose of study drug. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||Units on a scale||Standard Deviation|Mean
660607|NCT01855074|Secondary|Patient Satisfaction With Treatment|Participants’ were assessed for their satisfaction with the current antipsychotic treatment on a 5-point scale/questionnaire: very good, good, reasonable, moderate or poor.|Baseline and Week 26|The ITT population included all the participants who received at least 1 dose of study medication and had at least 1 follow-up visit. Here, 'n' signifies number of participants evaluable for this outcome measure at specific time point.||Participants|||Number
660608|NCT01855074|Secondary|Global Assessment of Functioning (GAF) Score|The GAF is a 100-point tool to measure overall psychological, social and occupational functioning of adults. The higher score range (91 to 100) refers to a superior functioning in a wide range of activities, and absence of symptoms. The lower score range (1 to 10) refers to persistent danger of severely hurting self or others; or persistent inability to maintain minimum personal hygiene; or serious suicidal act with clear expectation of death.|Baseline and Week 26|The ITT population included all the participants who received at least 1 dose of study medication and had at least 1 follow-up visit. Here, 'n' signifies number of participants evaluable for this outcome measure at specific time point.||Units on a scale||Standard Deviation|Mean
660609|NCT01855074|Secondary|Short Form-36 (SF-36) - Quality of Life Score|The SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: vitality, physical function, social function, physical role, emotional role, bodily pain, general health, mental health. Each item is scored on a scale ranging from 0-100 (100=highest level of functioning).|Baseline and Week 26|The ITT population included all the participants who received at least 1 dose of study medication and had at least 1 follow-up visit. Here, 'n' signifies number of participants evaluable for this outcome measure at specific time point.||Units on a scale||Standard Deviation|Mean
660610|NCT01855074|Secondary|Clinical Global Impressions (CGI) - Disease Severity Score|"The CGI rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants, higher scores indicate worsening."|Baseline and Week 26|The Intent-to-treat (ITT) population included all the participants who received at least 1 dose of study medication and had at least 1 follow-up visit. Here 'n' signifies number of participants evaluable for this outcome measure at specific time point.||Units on a scale||Standard Deviation|Mean
660645|NCT01854645|Secondary|Rescue Ventolin Hydrofluoroalkane (HFA) Use|Change from baseline in average daily rescue Ventolin HFA use|Baseline and at Week 24|Intent-to-Treat population with evaluable data (no imputation) for this outcome measure||Puffs / Day||95% Confidence Interval|Least Squares Mean
661213|NCT01844687|Other Pre-specified|Number of Optional Puffs of MJ Cigarette Taken|Mean number of puffs taken by those participants who chose to take additional puffs.|150 to 160 minutes after first marijuana cigarette was smoked earlier in the day|Those who took additional puffs of MJ cigarette.||number of puffs taken per participant||Standard Error|Mean
660611|NCT01855074|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 26|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210, higher scores indicate worsening. Change at Week 26 score is calculated as Baseline score minus Week 26 score.|Baseline and Week 26|The Intent-to-treat (ITT) population included all the participants who received at least 1 dose of study medication and had at least 1 follow-up visit. Here 'n' signifies number of participants evaluable for this outcome measure at specific time point.||Units on a scale||Standard Deviation|Mean
660612|NCT01854944|Secondary|Mean Change From Baseline in Clinical Global Impression-Improvement (CGI-I) Score|The efficacy of trial medication were rated for each participant using the CGI-I scale. The study physician must rate the participant's total improvement whether or not it is due entirely to drug treatment. All responses were compared to the participant's condition at baseline. Response choices include: 0 = not assessed; 1 =very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 =minimally worse; 6 = much worse; and 7 = very much worse. Last Visit is the last scheduled post-baseline evaluation including early termination evaluation.|Baseline to Day 6, 11 and Last Visit|The safety population included all participants who received at least one dose of study medication.||Units on a scale||Standard Deviation|Mean
660613|NCT01854944|Secondary|Mean Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score|"The severity of illness for each participant was rated using the CGI-S scale. To assess CGI-S, the study physician answered the following question: Considering your total clinical experience with this particular population, how mentally ill is the participant at this time? Response choices included: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants. Last Visit is the last scheduled post-baseline evaluation including early termination evaluation."|Baseline to Day 6, 11 and Last Visit|The safety population included all participants who received at least one dose of study medication.||Units on a scale||Standard Deviation|Mean
660614|NCT01854944|Secondary|Mean Change From Baseline in PANSS Negative Subscale Score|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS Negative Subscale ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms). Last Visit is the last scheduled post-baseline evaluation including early termination evaluation.|Baseline to Day 6, 11 and Last Visit|The safety population included all participants who received at least one dose of study medication.||Units on a scale||Standard Deviation|Mean
660615|NCT01854944|Secondary|Mean Change From Baseline in PANNS Positive Subscale Score|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS positive subscale score was the sum of the rating scores for the 7 positive scale items from the PANSS panel. The 7 positive symptom constructs are delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS Positive Subscale ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms). Last Visit is the last scheduled post-baseline evaluation including early termination evaluation.|Baseline to Day 6, 11 and Last Visit|The safety population included all participants who received at least one dose of study medication.||Units on a scale||Standard Deviation|Mean
660616|NCT01854944|Secondary|Mean Change From Baseline in Positive and Negative Symptom Scale (PANSS) Total Score|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome). Last Visit is the last scheduled post-baseline evaluation including early termination evaluation.|Baseline to Day 6, 11 and Last Visit|The safety sample included participants that are administered at least one dose of study medication.||Units on a scale||Standard Deviation|Mean
660617|NCT01854944|Secondary|Percentage of Participants Who Reported at Least One Occurrence of Suicidality, Suicidal Behavior and Suicidal Ideation on the Columbia-Suicide Severity Rating Scale (C-SSRS)|The C-SSRS captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. Suicidality was defined as reporting at least one occurrence of any suicidal behavior or suicidal ideation. Suicidal behavior was defined as reporting any type of suicidal behaviors (actual attempt, interrupted attempt, aborted attempt, and preparatory acts or behavior). The suicidal ideation intensity total score is the sum of intensity scores of 5 items (frequency, duration, controllability, deterrents, and reasons for ideation). The score of each intensity item ranges from 0 (none) to 5 (worst) which leads to the range of the total score from 0 to 25, with a higher score indicating a worse outcome. A missing score of any item resulted in a missing total score. If no suicidal ideation was reported, a score of 0 was given to the intensity scale. Last Visit is last scheduled post-baseline evaluation including early termination evaluation.|Baseline to Last Visit|The safety population included all participants who received at least one dose of study medication.||Percentage of participants|||Number
660628|NCT01854944|Primary|Change in Percentage Dopamine D2/D3 Receptor Occupancy|Dopamine receptor occupancy measured using the radiotracer [11C]-(+)-PHNO in low and high dose. The binding of brexpiprazole to the D2/D3 receptors were assessed by comparing the binding potential from the Baseline scan (prior to treatment) to that of Day 10 (after treatment). The D2/D3 receptors following administration of a 1- and 4-mg doses of brexpiprazole were assessed and the occupancy estimates were averaged across brain regions 4 hours post-last dose on Day 10.|Baseline to 4 hours post-last dose on Day 10|The positron emission tomography (PET) analysis included all participants who had both the Baseline and Day 10 PET scans performed.||percentage occupancy||Standard Deviation|Mean
660618|NCT01854944|Secondary|Mean Change From Baseline in Barnes Akathisia Rating Scale (BARS) Score|The BARS consisted of 4 items related to akathisia: objective observation of akathisia by the study physician, subjective feelings of restlessness by the participant, participant distress due to akathisia, and global evaluation of akathisia. The first 3 items were rated on a 4-point scale, with a score of 0 = absence of symptoms and a score of 3 = severe condition. The global clinical evaluation were made on a 6-point scale, (0=absent, 1=questionable, 2=mild, 3=moderate, 4=marked, 5=severe). To complete this scale, participants were observed while they were seated and then stood for a minimum of 2 minutes in each position. Symptoms observed in other situations (e.g., while engaged in neutral conversation or engaged in activity on the ward) may also be rated. Subjective phenomena were to be elicited by direct questioning. The BARS total score (when combined) ranged from 0 to 18, with higher values indicating a severe condition.|Baseline to Day 6, 11 and Last Visit|The safety population included all participants who received at least one dose of study medication.||Units on a scale||Standard Deviation|Mean
660619|NCT01854944|Secondary|Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score|The SAS is a rating scale used to measure EPS. The SAS scale consists of a list of 10 symptoms of parkinsonism (gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, head rotation, glabella tap, tremor, salivation, and akathisia), with each item rated from 0 to 4, with 0 being normal and 4 being the worst. The SAS Total score is sum of ratings for all 10 items, with possible Total scores from 0 to 40, with higher scores indicating worse outcome. Last Visit is the last scheduled post-baseline evaluation including early termination evaluation.|Baseline to Day 6, 11 and Last Visit|The safety population included all participants who received at least one dose of study medication.||Units on scale||Standard Deviation|Mean
660620|NCT01854944|Secondary|Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Score|The AIMS Scale was an extrapyramidal symptoms (EPS) rating scale. The AIMS is a 12 item scale. The first 10 items e.g. facial and oral movements (items 1-4), extremity movements (items 5 and 6), trunk movements (item 7), investigators global assessment of dyskinesia (items 8 to 10). The first 10 items are rated from 0 to 4 (0=best, 4=worst). Items 11 and 12, related to dental status, have dichotomous responses, 0=no and 1=yes. The AIMS Total Score is the sum of the ratings for the first seven items. The possible total scores are from 0 to 28, with a higher score indicating worse outcome. Last Visit is the last scheduled post-baseline evaluation including early termination evaluation.|Baseline to Day 6, 11 and Last Visit|The safety population included all participants who received at least one dose of study medication.||Units on a scale||Standard Deviation|Mean
660621|NCT01854944|Secondary|Time to Maximum (Peak) Plasma Concentration (Tmax) for Brexpiprazole and Its Metabolite DM-3411|Tmax for brexpiprazole and its metabolite DM-3411. Days 1 and 9: predose (within 15 minutes prior to dosing) Day 10: predose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 8, and 12 hours post-last dose.|Baseline to Day 10|The PK analysis included participants who had valid measurements (per clinical pharmacology). Blood samples were collected on Days 1 and 9 at predose and Day 10 at predose and at 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-last dose or at ET.||hour||Full Range|Median
660622|NCT01854944|Secondary|Apparent Clearance of Drug From Plasma After Extravascular Administration (CL/F; Only Brexpiprazole)|PK parameter - CL/F was assessed for brexpiprazole only. Days 1 and 9: predose (within 15 minutes prior to dosing) Day 10: predose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 8, and 12 hours post-last dose.|Baseline to Day 10|The PK analysis included participants who had valid measurements (per clinical pharmacology). Blood samples were collected on Days 1 and 9 at predose and Day 10 at predose and at 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-last dose or at ET.||mL/hr||Standard Deviation|Mean
660623|NCT01854944|Secondary|Peak (Maximal) Concentration of Drug in Plasma (Cmax) for Brexpiprazole and Its Metabolite DM-3411|(Cmax) Days 1 and 9: predose (within 15 minutes prior to dosing) Day 10: predose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 8, and 12 hours post-last dose.|Baseline to Day 10|The PK analysis included participants who had valid measurements (per clinical pharmacology). Blood samples were collected on Days 1 and 9 at predose and Day 10 at predose and at 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-last dose or at ET.||ng/mL||Standard Deviation|Mean
660624|NCT01854944|Secondary|Area Under the Concentration-time Curve (AUCτ) During a Dosing Interval at Steady-state for Brexpiprazole and Its Metabolite DM-3411|AUC during a dosing interval at steady-state for brexpiprazole and its metabolite DM-3411. Days 1 and 9: predose (within 15 minutes prior to dosing) Day 10: predose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 8, and 12 hours post-last dose.|Baseline to Day 10|The PK analysis included participants who had valid measurements (per clinical pharmacology). Blood samples were collected on Days 1 and 9 at predose and Day 10 at predose and at 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-last dose or at early termination (ET).||hr*ng/mL||Standard Deviation|Mean
660625|NCT01854944|Primary|Change in Occupancy at Serotonin Transporter (SERT)|Mean (±SD) SERT Occupancy Using the Radiotracer [11C]DASB in high dose only. Occupancy estimates were averaged across brain regions 4 hours post-last dose.|Baseline to 4 hours post-last dose on Day 10|The PET analysis included all participants who had both the Baseline and Day 10 PET scans performed.||percentage occupancy||Standard Deviation|Mean
660626|NCT01854944|Primary|Change in Percentage 5-HT2A Receptor Occupancy|Mean (±SD) Serotonin 5-HT2A Receptor Occupancy Using the Radiotracer [11C]MDL100907 (in low and high dose). The 5-HT2A receptors following administration of 1- and 4-mg doses of brexpiprazole were assessed and the occupancy estimates were averaged across brain regions 4 hours post-last dose on Day 10.|Baseline and 4 hours post-last dose on Day 10|The PET analysis included all participants who had both the Baseline and Day 10 PET scans performed.||percentage occupancy||Standard Deviation|Mean
660627|NCT01854944|Primary|Change in Percentage 5-HT1A Receptor Occupancy|Mean (±SD) Serotonin 5-HT1A Receptor Occupancy Using the Radiotracer [11C]CUMI101 in high dose only. In cohorts 1, 2 and 3, the binding of brexpiprazole to the 5-HT1A receptors was assessed by comparing the binding potential from the Baseline scan (prior to treatment) to that of Day 10 (after treatment). The 5-HT1A receptors following administration of a 4-mg dose of brexpiprazole was assessed and the occupancy estimates were averaged across brain regions 4 hours post-last dose on Day 10.|Baseline to 4 hours post-last dose on Day 10|The PET analysis included all participants who had both the Baseline and Day 10 PET scans performed.||percentage occupancy||Standard Deviation|Mean
660707|NCT01853982|Primary|Clinical Response at the End of Therapy Visit||24 hours after last dose of study drug|There is no analysis population or data available for this measure. This study was electively terminated to focus on a larger registrational study, which was also part of the clinical development program for nosocomial pneumonia.|||||
660632|NCT01854697|Secondary|Percentage of Participants With Virologic Failure During Treatment|"Participants in Arms A, C or D demonstrating any of the following were considered virologic failures and discontinued therapy:
Confirmed increase from nadir in HCV RNA (defined as 2 consecutive HCV RNA measurements of >1 log10 IU/mL above nadir) at any time point during treatment
Failure to achieve HCV RNA < LLOQ by Week 6 or
Confirmed HCV RNA ≥ LLOQ (defined as 2 consecutive HCV RNA measurements ≥ LLOQ) at any point after HCV RNA < LLOQ during treatment after HCV RNA < LLOQ.
Participants in Arms B and E followed virologic stopping criteria described in the TPV Summary of Product Characteristics; they were considered virologic failures and discontinued therapy as follows:
HCV RNA > 1000 IU/mL at Week 4 to Week 12, discontinue TPV and pegIFN and RBV
HCV RNA > 1000 IU/mL at Week 12, discontinue pegIFN and RBV
Confirmed HCV RNA > lower limit of detection (LLOD) at Week 24, discontinue pegIFN and RBV
Confirmed HCV RNA > LLOD at Week 36, discontinue pegIFN and RBV."|12 weeks for Arms A, C and D and 24 weeks or 48 weeks for Arms B and E|Intent-to-treat Population: all randomized participants who received at least 1 dose of study drug.||percentage of participants|||Number
660633|NCT01854697|Secondary|Percentage of Participants With SVR12 - Secondary Efficacy Analyses|The percentage of participants with sustained virologic response (plasma HCV RNA level < LLOQ) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of active study drug|Intent-to-treat Population: all randomized participants who received at least 1 dose of study drug.||percentage of participants|||Number
660634|NCT01854697|Secondary|Mean Change From Baseline to the Final Treatment Visit in SF-36V2 Physical Component Summary (PCS)|SF-36V2 is a generic 36-item questionnaire measuring HRQoL covering 2 summary measures: PCS and MCS; it consists of 8 subscales. The PCS is represented by 4 subscales: physical function, role limitations due to physical problems, bodily pain, and general health perception. Participants self-report on items in a subscale that have choices per item. Scoring is done for both PCS subscale scores and summary scores; for each, the range is 0 (worst HRQoL) to 100 (best HRQoL).|From Day 1 of treatment up to 12 weeks for Arms A, C and D and up to 24 or 48 weeks for Arms B and E|Intent-to-treat Population: all randomized participants who received at least 1 dose of study drug and a baseline and post-baseline value.||units on a scale||Standard Deviation|Mean
660635|NCT01854697|Secondary|Mean Change From Baseline to the Final Treatment Visit in Short-Form 36 Version 2 Health Status Survey (SF-36V2) Mental Component Summary (MCS)|SF-36V2 is a generic 36-item questionnaire measuring health-related quality of life (HRQoL) covering 2 summary measures: physical component summary (PCS) and MCS; it consists of 8 subscales. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have choices per item. Scoring is done for both MCS subscale scores and summary scores; for each, the range is 0 (worst HRQoL) to 100 (best HRQoL).|From Day 1 of treatment up to 12 weeks for Arms A, C and D and up to 24 or 48 weeks for Arms B and E|Intent-to-treat Population: all randomized participants who received at least 1 dose of study drug and a baseline and post-baseline value.||units on a scale||Standard Deviation|Mean
660636|NCT01854697|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment (SVR12) - Primary Efficacy Analyses|The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of active study drug|Intent-to-treat Population: all randomized participants who received at least 1 dose of study drug.||percentage of participants|||Number
660637|NCT01854658|Secondary|Onset of Action as Assessed by FEV1|Defined as the first time-point using the 5- and 15-minute post dose measurements where the difference in FEV1 from Placebo was statistically significant|Day 1|Intent-to-Treat population with evaluable data (no imputation) for this outcome measure.||Liters||95% Confidence Interval|Least Squares Mean
660638|NCT01854658|Secondary|Rescue Ventolin HFA Use|Change from baseline in average daily rescue Ventolin HFA use over 24 weeks|24 weeks|Intent-to-Treat population with evaluable data (no imputation) for this outcome measure.||Puffs / Day||95% Confidence Interval|Least Squares Mean
660639|NCT01854658|Secondary|St. George Respiratory Questionnaire (SGRQ) Score|Change from baseline in the SGRQ total score at Week 24. The SGRQ is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of GFF MDI, FF MDI and GP MDI on health-related quality of life as compared to placebo in subjects with COPD. The scores range from 0 (minimum, best possible health status) to 100 (maximum, worst possible health status). The SGRQ contains 76 items grouped into three domains (symptoms, activity and impacts). Change from Baseline at a particular visit was calculated as the SGRQ total score at that visit minus Baseline. Change from Baseline in total score of -4 units or lower is considered as clinically meaningful improvement in quality of life.|24 weeks|Intent-to-Treat population with evaluable data (no imputation) for this outcome measure.||Scores on a scale||95% Confidence Interval|Least Squares Mean
660640|NCT01854658|Secondary|Peak FEV1|Peak change from baseline in FEV1 within 2 hours post-dosing at Week 24|At week 24|Intent-to-Treat population with evaluable data (no imputation) for this outcome measure.||Liters||95% Confidence Interval|Least Squares Mean
660641|NCT01854658|Secondary|Change From Baseline in Morning Pre-dose Trough FEV1 Over 24 Weeks|Change from baseline in morning pre-dose trough forced expiratory volume in 1 second (FEV1) over 24 weeks. FEV1 was assessed at multiple time points post-baseline, and a model-based average of all visits starting from Week 2 through week 24 inclusive was calculated. The change values reported in the table represent the change between the baseline and the average FEV1 post-baseline.|Over 24 weeks|Intent-to-Treat population with evaluable data (no imputation) for this outcome measure.||Liters||95% Confidence Interval|Least Squares Mean
660642|NCT01854658|Primary|Change From Baseline in Morning Pre-dose Trough FEV1|Change from baseline in morning pre-dose trough forced expiratory volume in 1 second (FEV1) at Week 24.|At Week 24|Intent-to-Treat population with evaluable data (no imputation) for this outcome measure.||Liters||95% Confidence Interval|Least Squares Mean
660643|NCT01854645|Secondary|Peak Change From Baseline in FEV1 Within 2 Hours Post-dose|Peak change from baseline in forced expiratory volume in 1 second (FEV1) within 2 hours post-dose|Baseline and at Week 24|Intent-to-Treat population with evaluable data (no imputation) for this outcome measure||Liters||95% Confidence Interval|Least Squares Mean
660644|NCT01854645|Secondary|Onset of Action as Assessed by FEV1|Defined as the first time-point using the 5- and 15-minute post dose measurements where the difference in FEV1 from Placebo was statistically significant|Assessed for 5- and 15-minute post dose on Day 1|Intent-to-Treat population with evaluable data (no imputation) for this outcome measure||Liters||95% Confidence Interval|Least Squares Mean
660646|NCT01854645|Secondary|St. George's Respiratory Questionnaire (SGRQ) Score|Change from baseline in the SGRQ total score. The SGRQ is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of GFF MDI, FF MDI and GP MDI on health-related quality of life as compared to placebo in subjects with COPD. The scores range from 0 (minimum, best possible health status) to 100 (maximum, worst possible health status). The SGRQ contains 76 items grouped into three domains (symptoms, activity and impacts). Change from Baseline at a particular visit was calculated as the SGRQ total score at that visit minus Baseline. Change from Baseline in total score of -4 units or lower is considered as clinically meaningful improvement in quality of life.|Baseline and at Week 24|Intent-to-Treat population with evaluable data (no imputation) for this outcome measure||Scores on a scale||95% Confidence Interval|Least Squares Mean
660647|NCT01854645|Secondary|Change From Baseline in Morning Pre-dose Trough FEV1 Over 24 Weeks|Change from baseline in morning pre-dose trough forced expiratory volume in 1 second (FEV1) over 24 weeks. FEV1 was assessed at multiple time points post-baseline,and a modelbased average of all visits starting from Week 2 through week 24 inclusive was calculated. The change values reported in the table represent the change between the baseline and the average FEV1 post-baseline.|Baseline and Weeks 2 to 24|Intent-to-Treat population with evaluable data (no imputation) for this outcome measure||Liters||95% Confidence Interval|Least Squares Mean
660648|NCT01854645|Primary|Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24|Change from baseline in morning pre-dose trough forced expiratory volume in 1 second (FEV1) at Week 24|Baseline and at Week 24|Intent-to-Treat population with evaluable data (no imputation) for this outcome measure||Liters||95% Confidence Interval|Least Squares Mean
660649|NCT01854632|Secondary|Evaluation of Vaccine-take as Shedding of Vaccine Virus Post-vaccination, Including Viral Load and Duration of Virus Detection|Vaccine take will be parameterized as the percentage of participants with detectable vaccine-virus in nasal or throat swab on each day pre- (day 0) and post vaccination (i.e., 2 and 4 days post vaccination), and the quantity of detected virus.|Through 4 days post vaccination||||||
660650|NCT01854632|Secondary|Etiologies of Influenza-like Illness in the Study Population|Bacterial and viral etiologies of acute respiratory and febrile illness will be parameterized as the percentage of those with each particular laboratory-confirmed infection categorized by vaccine allocation.|Through 7 to 8 months post vaccination||||||
660651|NCT01854632|Secondary|Clinical Characteristics of Influenza in the Study Population||Through 7 to 8 months post vaccination||||||
660652|NCT01854632|Secondary|Percentage of Participants With Symptomatic, Laboratory-confirmed Influenza Virus Infection by Influenza Type/Subtype (Influenza A/H1N1, Influenza A/H3N2, and Influenza B)||Through 7 to 8 months post vaccination||||||
660653|NCT01854632|Secondary|Percentage of Participants With Symptomatic, Laboratory-confirmed Influenza Virus Infection (Vaccine-matched Strains)||Through 7 to 8 months post vaccination||||||
660654|NCT01854632|Secondary|Safety Profile of LAIV: Protocol Defined Wheezing Illness||Through 7 to 8 months post vaccination||||||
660655|NCT01854632|Secondary|Safety Profile of LAIV: Other Non-serious Adverse Events||Through 1 month post vaccination||||||
660656|NCT01854632|Secondary|Safety Profile of LAIV: Serious Adverse Events||Through 1 month post vaccination||||||
660657|NCT01854632|Secondary|Safety Profile of LAIV: Solicited and Unsolicited Local and Systemic Reactions||Through 7 days post vaccination||||||
660658|NCT01854632|Secondary|Safety Profile of LAIV: Immediate Reactions Occurring Within 30 Minutes of Administration of Study Vaccine.||Through 30 minutes post vaccination||||||
660659|NCT01854632|Primary|Percentage of Participants With Symptomatic, Laboratory-confirmed Influenza Virus Infection (Regardless of Vaccine Match)||Through 7 to 8 months post vaccination|All participants meeting per-protocol analysis criteria.||percentage of participants|||Number
660660|NCT01854593|Secondary|Silicon Oil Tamponade|The number of participants with silicon oil tamponade at the end of the surgery.|End of surgery.|||participants|||Number
660661|NCT01854593|Secondary|Gas Tamponade|The number of participants with gas tamponade at the end of the surgery.|End of surgery.|||participants|||Number
660662|NCT01854593|Secondary|Elevated Intraocular Pressure|The number of participants with elevated intraocular pressure after surgery.|Within 1 month after the surgery.|||participants|||Number
660663|NCT01854593|Secondary|Postoperative Neovascular Glaucoma|The number of participants with progressive or persistent neovascular glaucoma after surgery.|Within 1 month after the surgery.|||participants|||Number
660664|NCT01854593|Secondary|Best Corrected Visual Acuity Change|"Best corrected visual acuity change was calculated by postoperative logMAR visual acuity minus preoperative logMAR visual acuity.
The higher values represent a worse outcome."|1 month|||LogMAR||Standard Deviation|Mean
660665|NCT01854593|Secondary|Postoperative Best Corrected Visual Acuity|"Best corrected visual acuity was measured using the Landolt ring chart, and the result was converted to logMAR notation for analysis.
The minimum of the scale is 2.0 and the maximum of the scale is -0.3. The higher values represent a worse outcome."|1 mouth after surgery.|||LogMAR||Standard Deviation|Mean
660666|NCT01854593|Secondary|Surgical Time||End of surgery.|||minutes||Standard Deviation|Mean
660667|NCT01854593|Secondary|Iatrogenic Retinal Tears|The number of participants who had intraoperative iatrogenic retinal tears.|End of surgery.|||participants|||Number
660668|NCT01854593|Secondary|Endolaser Photocoagulation|Number of intraoperative endolaser photocoagulation.|End of surgery.|||photocoagulation||Standard Deviation|Mean
660669|NCT01854593|Secondary|Vascular Endothelial Growth Factor Concentration in Vitreous|Vascular endothelial growth factor concentration in vitreous at the start of vitrectomy.|Start of surgery.|||μg/ml||Standard Deviation|Mean
660670|NCT01854593|Primary|Reoperation|Vitreoretinal reoperation due to recurrent vitreous hemorrhage.|1 month|||participants|||Number
660671|NCT01854593|Secondary|Postoperative Vitreous Hemorrhage.|Postoperative vitreous hemorrhage that is permitted within 4 weeks after surgery.|1 month|||participants|||Number
660672|NCT01854593|Secondary|Intra Operative Hemorrhage|Calculate the number of coagulators for the intra operative hemorrhage.|End of the surgery.|||coagulators||Standard Deviation|Mean
660871|NCT01851330|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) 12 weeks following the last dose of study drug.|Posttreatment Week 12|Full Analysis Set: participants were randomized and received at least one dose of study medication.||percentage of participants|||Number
660673|NCT01854528|Secondary|Percentage of Participants With Virologic Relapse After Treatment|Participants who completed treatment with plasma HCV RNA less than the lower limit of quantification (<LLOQ) at the end of treatment were considered to have virologic relapse if they had confirmed HCV RNA ≥ LLOQ during the post-treatment period.|Between end of treatment (Week 12 for 3-DAA/RBV and Week 24 or 48 for TPV/RBV) and Post-treatment (up to Week 12 Post-treatment)|ITT population.||percentage of participants||95% Confidence Interval|Number
660674|NCT01854528|Secondary|Percentage of Participants With Virologic Failure During Treatment|Virologic failure during treatment was defined as HCV ribonucleic acid (RNA) confirmed greater than or equal to the lower limit of quantification (≥ LLOQ) after HCV RNA < LLOQ during treatment or confirmed HCV RNA ≥ LLOQ at the end of treatment.|Baseline to end of treatment (12 weeks for 3-DAA/RBV and 24 or 48 weeks for TPV/RBV)|ITT population.||percentage of participants||95% Confidence Interval|Number
660675|NCT01854528|Secondary|Percentage of Participants With Sustained Virologic Response 24 Weeks After Treatment|The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 24 weeks after the last dose of study drug. The LLOQ for the assay was 25 IU/mL.|24 weeks after the last dose of study drug|All participants in the ITT population with evaluable data.||percentage of participants|||Number
660676|NCT01854528|Secondary|Mean Change From Baseline to Final Treatment Visit in the Physical Component Summary (PCS) Score of the Short-Form 36 Health Survey – Version 2 (SF-36v2)|The SF-36v2 is a general health-related quality of life (HRQoL) instrument with extensive use in multiple disease states. The SF-36v2 instrument comprises a total of 36 items (questions) targeting a participant's functional health and well-being in 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Domain scores were aggregated into a PCS score (range = 0 to 100; a higher score indicates better mental function and well-being).|Baseline and Final Treatment Visit (up to Week 12 for 3-DAA/RBV and up to Week 24 or 48 for TPV/RBV)|All participants in the ITT population with evaluable data.||units on a scale||Standard Deviation|Mean
660677|NCT01854528|Secondary|Mean Change From Baseline to Final Treatment Visit in the Mental Component Summary (MCS) Score of the Short-Form 36 Health Survey – Version 2 (SF-36v2)|The SF-36v2 is a general health-related quality of life (HRQoL) instrument with extensive use in multiple disease states. The SF-36v2 instrument comprises a total of 36 items (questions) targeting a participant's functional health and well-being in 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Domain scores were aggregated into an MCS score (from 0 to 100; a higher score indicates better mental function and well-being).|Baseline and Final Treatment Visit (up to Week 12 for 3-DAA/RBV and up to Week 24 or 48 for TPV/RBV)|All participants in the ITT population with evaluable data.||units on a scale||Standard Deviation|Mean
660678|NCT01854528|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment|The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug. The LLOQ for the assay was 25 IU/mL.|12 weeks after the last dose of study drug|ITT population: All randomized participants who received at least 1 dose of study drug.||percentage of participants|||Number
660679|NCT01854281|Primary|Arterial Nitrogen Bubbles After Surfacing|Arterial gas bubbles are detected by transcranial doppler ultrasonography. Positive outcome is 1 or more bubbles detected.|assesed within 1 hour after surfacing|||participants|||Number
660680|NCT01854268|Secondary|Urge-to-cough|Urge-to-cough: A measure of respiratory sensation that rates the perceived magnitude of the need to cough on a Borg scale (0=no urge-to-cough; 10=maximal urge-to-cough).|1 hour|||units on a scale||Standard Error|Median
660681|NCT01854268|Secondary|Peak Expiratory Airflow Rate|Airflow measures: Peak expiratory airflow rate Peak expiratory flow rate is a measure of the velocity of air expelled from the respiratory apparatus during cough. Measured in liters/second.|1 hour|||Liters/second||Standard Deviation|Mean
660682|NCT01854268|Primary|Lung Volume Initiation|Respiratory kinematic measure: lung volume initiation (LVI) Lung volume initiation is a measure of the volume of air in the lungs prior to a respiratory task.|1 hour|25 healthy young volunteers participated in this study. The average age was 23 years and none had a history of respiratory or neurological disease.||% Vital Capacity, relative to EEL||Standard Deviation|Mean
660683|NCT01854242|Primary|Serologic, Genetic and Inflammatory Markers Consistent With Inflammatory Bowel Disease|Participants who tested positive for Crohn disease, ulcerative colitis, or unspecified inflammatory bowel disease (IBD) on a panel for IBD are reported in the Outcome Measure Data Table.|2 weeks|||participants testing positive|||Number
660684|NCT01854047|Post-Hoc|Change From Baseline in FEV1 at Week 12: Subset of ITT Population With Baseline Blood Eosinophil <0.3 G/L|FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.|Baseline, Week 12|Analysis was performed on subset of ITT population which included participants with baseline blood eosinophil count <0.3 G/L.||liter||Standard Deviation|Mean
660685|NCT01854047|Secondary|Change From Baseline in Number of Inhalations Per Day of Salbutamol/Albuterol or Levosalbutamol/Levalbuterol at Week 12: ITT Population|Participants might administered salbutamol/albuterol or levosalbutamol/levalbuterol as reliever medication as needed during the study. The number of salbutamol/albuterol or levosalbutamol/levalbuterol inhalations were recorded by the participants in their electronic diary.|Baseline, Week 12|ITT population.||inhalations per day||Standard Deviation|Mean
660686|NCT01854047|Secondary|Change From Baseline in Number of Inhalations Per Day of Salbutamol/Albuterol or Levosalbutamol/Levalbuterol at Week 12: HEos-ITT Population|Participants might administered salbutamol/albuterol or levosalbutamol/levalbuterol as reliever medication as needed during the study. The number of salbutamol/albuterol or levosalbutamol/levalbuterol inhalations were recorded by the participants in their electronic diary.|Baseline, Week 12|HEos-ITT Population.||inhalations per day||Standard Deviation|Mean
660708|NCT01853839|Secondary|Adverse Events Under Angiotensin II (Type 1) Receptor Blockers (ARBs) Treatment When Given in Combination With Calcium-Channel Blockers (CCBs)|Number of participants with adverse events in participants receiving Angiotensin II (Type 1) Receptor Blockers (ARBs) when given in combination with Calcium-Channel Blockers (CCBs) during the whole study duration.|Up to 52 weeks|All subjects who took a combination of ARB and CCB drugs.||participants|||Number
660687|NCT01854047|Secondary|Change From Baseline in AQLQ Global Score at Week 12: ITT Population|The AQLQ is a disease-specific, self-administered quality of life questionnaire designed to measure functional impairments that are most important to participants with asthma. The AQLQ comprises of 32 items in 4 domains: symptoms (12 items), activity limitation (11 items), emotional function (5 items), environmental stimuli (4 items). Each item is scored on a 7-point Likert scale (1=maximal impairment, 7=no impairment). The 32 items of the questionnaire are averaged to produce one overall quality of life score ranging from 1 (severely impaired) to 7 (not impaired at all). Higher scores indicate better quality of life.|Baseline, Week 12|ITT population.||scores on a scale||Standard Deviation|Mean
660688|NCT01854047|Secondary|Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Global Score at Week 12: HEos-ITT Population|The AQLQ is a disease-specific, self-administered quality of life questionnaire designed to measure functional impairments that are most important to participants with asthma. The AQLQ comprises of 32 items in 4 domains: symptoms (12 items), activity limitation (11 items), emotional function (5 items), environmental stimuli (4 items). Each item is scored on a 7-point Likert scale (1=maximal impairment, 7=no impairment). The 32 items of the questionnaire are averaged to produce one overall quality of life score ranging from 1 (severely impaired) to 7 (not impaired at all). Higher scores indicate better quality of life.|Baseline, Week 12|HEos-ITT population.||scores on a scale||Standard Deviation|Mean
660689|NCT01854047|Secondary|Change From Baseline in ACQ-5 Score at Week 12: ITT Population|The ACQ-5 has 5 questions, reflecting the top-scoring five asthma symptoms: woken at night by symptoms, wake in the mornings with symptoms, limitation of daily activities, shortness of breath and wheeze. Participants were asked to recall how their asthma had been during the previous week and to respond to each of the five symptom questions on a 7-point scale ranged from 0 (no impairment) to 6 (maximum impairment). ACQ-5 total score was mean of the scores of all 5 questions and, therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled). Higher score indicated lower asthma control.|Baseline, Week 12|ITT population.||scores on a scale||Standard Deviation|Mean
660690|NCT01854047|Secondary|Change From Baseline in Asthma Control Questionnaire 5-item Version (ACQ-5) Score at Week 12: HEos-ITT Population|The ACQ-5 has 5 questions, reflecting the top-scoring five asthma symptoms: woken at night by symptoms, wake in the mornings with symptoms, limitation of daily activities, shortness of breath and wheeze. Participants were asked to recall how their asthma had been during the previous week and to respond to each of the five symptom questions on a 7-point scale ranged from 0 (no impairment) to 6 (maximum impairment). ACQ-5 total score was mean of the scores of all 5 questions and, therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled). Higher score indicated lower asthma control.|Baseline, Week 12|HEos-ITT population.||scores on a scale||Standard Deviation|Mean
660691|NCT01854047|Secondary|Change From Baseline in Evening Asthma Symptom Score at Week 12: ITT Population|Evening asthma symptom score was determined using PM symptom scoring system which evaluated participant’s overall asthma symptoms experienced during the day. It ranged from 0 to 4 as: 0=very well, no asthma symptoms, 1=one episode of wheezing, cough, or breathlessness, 2=more than one episode of wheezing, cough, or breathlessness without interference of normal activities, 3=wheezing, cough, or breathlessness most of the day, which interfered to some extent with normal activities, 4=asthma very bad, unable to carry out daily activities as usual.|Baseline, Week 12|ITT population.||scores on a scale||Standard Deviation|Mean
660692|NCT01854047|Secondary|Change From Baseline in Evening Asthma Symptom Score at Week 12: HEos-ITT Population|Evening asthma symptom score was determined using PM (post meridiem) symptom scoring system which evaluated participant’s overall asthma symptoms experienced during the day. It ranged from 0 to 4 as: 0=very well, no asthma symptoms, 1=one episode of wheezing, cough, or breathlessness, 2=more than one episode of wheezing, cough, or breathlessness without interference of normal activities, 3=wheezing, cough, or breathlessness most of the day, which interfered to some extent with normal activities, 4=asthma very bad, unable to carry out daily activities as usual.|Baseline, Week 12|HEos ITT population.||scores on a scale||Standard Deviation|Mean
660693|NCT01854047|Secondary|Change From Baseline in Morning Asthma Symptom Score at Week 12: ITT Population|Morning asthma symptom score was determined using AM symptom scoring system which evaluated participant’s overall asthma symptoms experienced during the night. It ranged from 0 to 4 as: 0 = No asthma symptoms, slept through the night, 1= Slept well, but some complaints in the morning, no night-time awakenings, 2= Woke up once because of asthma (including early awakening), 3= Woke up several times because of asthma (including early awakening), 4= Bad night, awake most of the night because of asthma.|Baseline, Week 12|ITT population.||scores on a scale||Standard Deviation|Mean
660694|NCT01854047|Secondary|Change From Baseline in Morning Asthma Symptom Score at Week 12: HEos-ITT Population|Morning asthma symptom score was determined using AM (ante meridiem) symptom scoring system which evaluated participant’s overall asthma symptoms experienced during the night. It ranged from 0 to 4 as: 0 = No asthma symptoms, slept through the night, 1= Slept well, but some complaints in the morning, no night-time awakenings, 2= Woke up once because of asthma (including early awakening), 3= Woke up several times because of asthma (including early awakening), 4= Bad night, awake most of the night because of asthma.|Baseline, Week 12|HEos-ITT population.||scores on a scale||Standard Deviation|Mean
660695|NCT01854047|Secondary|Time to First LOAC Event: Kaplan-Meier Estimates at Week 12 and Week 24: ITT Population|The time to first LOAC event was defined as the time from the date of first dose to the date of the first LOAC event. For participants who had no LOAC event on or before last dose date + 14 days, it was censored at the date of last dose date + 14 days. The median time to first LOAC was not estimated because the number of LOAC was too low in the Dupilumab arms. Therefore, alternative Kaplan-Meier statistics, the probability of LOAC at Week 12 and 24, are presented as the descriptive measure statistics.|Baseline up to Week 24|ITT population. Here 'overall number of participants analyzed' signifies participants of the ITT population who were treated.||probability of LOAC||95% Confidence Interval|Number
660723|NCT01853605|Primary|Local Complications|Local complications are the cumulative complications occurring in at least 5% of subjects in 1 or more cohorts over the duration of the study. The Kaplan-Meier risk rate is presented.|5 years|Evaluable population: all enrolled subjects implanted with the NATRELLE 410 original style implants who completed the 5 year follow-up visit.||Percentage of Subjects||95% Confidence Interval|Number
660872|NCT01850589|Primary|Number of Participants With Smoking Cessation at 12 Months|Conservative vs. aggressive smoking strategies in treating smoking cessation.|12 months|Mean follow up was 7.3 months||Participants|||Number
660696|NCT01854047|Secondary|Time to First LOAC Event: Kaplan-Meier Estimates at Week 12 and Week 24: HEos-ITT Population|The time to first LOAC event was defined as the time from the date of first dose to the date of the first LOAC event. For participants who had no LOAC event on or before last dose date + 14 days, it was censored at the date of last dose date + 14 days. The median time to first LOAC was not estimated because the number of LOAC was too low in the Dupilumab arms. Therefore, alternative Kaplan-Meier statistics, the probability of LOAC at Week 12 and 24, are presented as the descriptive measure statistics.|Baseline up to Week 24|HEos-ITT population. Here ‘overall number of participants analyzed’ signifies participants of the HEos-ITT population who were treated.||probability of LOAC||95% Confidence Interval|Number
660697|NCT01854047|Secondary|Annualized Event Rate of LOAC During The Treatment Period: ITT Population|LOAC was defined as any of the following: >=6 additional reliever puffs of salbutamol/albuterol or levosalbutamol/levalbuterol in a 24-hour period (compared to baseline) on 2 consecutive days; increase in ICS >=4 times the dose at randomization; use of systemic corticosteroids for >=3 days; hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of LOAC that occurred during the treatment period divided by the total number of participant-years treated.|Baseline to Week 24|ITT population. Here 'overall number of participants analyzed' signifies participants of the ITT population who were treated.||LOAC per participant-year||95% Confidence Interval|Number
660698|NCT01854047|Secondary|Annualized Event Rate of Loss of Asthma Control (LOAC) During The Treatment Period: HEos-ITT Population|LOAC was defined as any of the following: >=6 additional reliever puffs of salbutamol/albuterol or levosalbutamol/levalbuterol in a 24-hour period (compared to baseline) on 2 consecutive days; increase in inhaled corticosteroid (ICS) >=4 times the dose at randomization; use of systemic corticosteroids for >=3 days; hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of LOAC that occurred during the treatment period divided by the total number of participant-years treated.|Baseline to Week 24|HEos-ITT population. Here ‘overall number of participants analyzed’ signifies participants of the HEos-ITT population who were treated.||LOAC per participant-year||95% Confidence Interval|Number
660699|NCT01854047|Secondary|Time to First Severe Exacerbation: Kaplan-Meier Estimates at Week 12 and 24: ITT Population|The time to first severe exacerbation was defined as the time from the date of first dose to the date of the first severe exacerbation event. For participants who had no severe exacerbation on or before last dose date + 14 days, it was censored at the date of last dose date + 14 days. The median time to first severe exacerbation was not estimated because the number of severe exacerbations was too low in the Dupilumab arms. Therefore, alternative Kaplan-Meier statistics, the probability of severe exacerbation at Week 12 and 24, are presented as the descriptive measure statistics.|Baseline up to Week 24|ITT population. Here 'overall number of participants analyzed' signifies participants of ITT population who were treated.||probability of Severe Exacerbation||95% Confidence Interval|Number
660700|NCT01854047|Secondary|Time to First Severe Exacerbation: Kaplan-Meier Estimates at Week 12 and 24: HEos-ITT Population|The time to first severe exacerbation was defined as the time from the date of first dose to the date of the first severe exacerbation event. For participants who had no severe exacerbation on or before last dose date + 14 days, it was censored at the date of last dose date + 14 days. The median time to first severe exacerbation was not estimated because the number of severe exacerbations was too low in the Dupilumab arms. Therefore, alternative Kaplan-Meier statistics, the probability of severe exacerbation at Week 12 and 24, are presented as the descriptive measure statistics.|Baseline up to Week 24|HEos-ITT population. Here ‘overall number of participants analyzed’ signifies participants of the HEos-ITT population who were treated.||probability of Severe Exacerbation||95% Confidence Interval|Number
660701|NCT01854047|Secondary|Annualized Event Rate of Severe Exacerbation During The Treatment Period: ITT Population|A severe exacerbation was defined as a deterioration of asthma requiring: use of systemic corticosteroids for >=3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated.|Baseline to Week 24|ITT population. Here 'overall number of participants analyzed' signifies participants of the ITT population who were treated.||exacerbation per participant-year||95% Confidence Interval|Number
660702|NCT01854047|Secondary|Annualized Event Rate of Severe Exacerbation During The Treatment Period: HEos-ITT Population|A severe exacerbation was defined as a deterioration of asthma requiring: use of systemic corticosteroids for >=3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated.|Baseline to Week 24|HEos-ITT population. Here ‘overall number of participants analyzed’ signifies participants of the HEos-ITT population who were treated.||exacerbation per participant-year||95% Confidence Interval|Number
660703|NCT01854047|Secondary|Percent Change From Baseline in FEV1 at Week 12: ITT Population|FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.|Baseline, Week 12|ITT population. Here 'overall number of participants analyzed' signifies participants with available data for this outcome measure.||percent change||Standard Deviation|Mean
660704|NCT01854047|Secondary|Percent Change From Baseline in FEV1 at Week 12: HEos-ITT Population|FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.|Baseline, Week 12|HEos-ITT population. Here 'overall number of participants analyzed' signifies participants with available data for this outcome measure.||percent change||Standard Deviation|Mean
660705|NCT01854047|Primary|Absolute Change From Baseline in FEV1 at Week 12: ITT Population|FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.|Baseline, Week 12|ITT population.||liter||Standard Deviation|Mean
660706|NCT01854047|Primary|Absolute Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 12: High Eosinophils -Intent to Treat (HEos-ITT) Population|FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.|Baseline, Week 12|HEos-ITT population: subset of intent to treat (ITT) population (defined as randomized population analyzed according to the treatment group allocated by randomization, regardless of whether the treatment was actually received) which included participants with baseline blood eosinophils >=0.3 G/L.||liter||Standard Deviation|Mean
660873|NCT01850550|Secondary|Dietary Intake|Assessed using the NCI Dietary History Questionnaire|12 weeks after initial consent||||||
660709|NCT01853839|Secondary|The Percentage of Patients Achieving JNC 7 Treatment Goals at the End of the 1 Year Treatment Duration|The proportion of patients enrolled in the study who achieve the JNC 7 (the seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure) treatment goals (blood pressure (BP) <140/90 mmHg) in a primary-care setting at the end of the 1 year treatment duration. This variable was derived from the mean sitting blood pressure assessed by the investigators at the end of the 1 year treatment duration. To achieve JNC 7 treatment goals, the subject had to satisfy both blood pressure criteria - systolic blood pressure below 140 mm Hg and diastolic blood pressure below 90 mm Hg. At this timepoint, a diagnosis of diabetes mellitus and/or kidney disease was also taken into account. Subjects with either of the mentioned conditions had to have systolic blood pressure lower than 130 mm Hg and diastolic blood pressure below 80 mm Hg to satisfy JNC 7 treatment goals.|Up to 52 weeks|Per-protocol population||Percentage of participants|||Number
660710|NCT01853839|Secondary|The Difference in Diastolic Blood Pressure Before and After the Month of Ramadan|Change from baseline in diastolic blood pressure before and after the month of Ramadan|Baseline, 10 days before Ramadan, 10 days after Ramadan and 52 weeks|Per-protocol population||mmHg||Standard Deviation|Mean
660711|NCT01853839|Secondary|The Difference in Systolic Blood Pressure Before and After the Month of Ramadan|Change from baseline in systolic blood pressure before and after the month of Ramadan|Baseline, 10 days before Ramadan, 10 days after Ramadan and 52 weeks|Per-protocol population||mmHg||Standard Deviation|Mean
660712|NCT01853839|Secondary|Achievement of the JNC 7 Treatment Goals During the Whole Study Duration (Treated by Internists and Cardiologists as Primary Physician)|Proportion of patients who achieved the JNC 7 treatment goals during the whole study duration (treated by internists and cardiologists as primary physician)|Up to 52 weeks|Per-protocol population||Percentage of participants|||Number
660713|NCT01853839|Secondary|Compliance of Patients During the Whole Study Duration (52 Weeks)|"Compliance of patients during the whole study duration (treated by internists and cardiologists as primary physician). Subjects were asked how often they have not taken their medicine and were given five possible choices from none of the time to all of the time."|Up to 52 weeks|Per-protocol population including all patients with data at 52 weeks||Percentage of participants|||Number
660714|NCT01853839|Secondary|Compliance of Patients up to 10 Days After Ramadan|"Compliance of patients up to 10 days after Ramadan (treated by internists and cardiologists as primary physician). Subjects were asked how often they have not taken their medicine and were given five possible choices from none of the time to all of the time."|10 days after Ramadan|Per-protocol population including all patients with data 10 days after Ramadan||Percentage of participants|||Number
660715|NCT01853839|Secondary|Compliance of Patients up to 10 Days Before Ramadan|"Compliance of patients up to 10 days before ramadan (treated by internists and cardiologists as primary physician). Subjects were asked how often they have not taken their medicine and were given five possible choices from none of the time to all of the time."|10 days before Ramadan|Per-protocol population including all patients with data 10 days before Ramadan||Percentage of participants|||Number
660716|NCT01853839|Secondary|The Overall Assessment of Treatment by Physicians at 52 Weeks|The overall assessment of treatment by physicians at 52 weeks. Assessed using a verbal rating scale with 5 categories: Outstanding, very satisfactory, satisfactory, marginal and not satisfactory.|Up to 52 weeks|Per-protocol population||Percentage of participants|||Number
660717|NCT01853839|Secondary|The Overall Assessment of Treatment by Patients at 52 Weeks|The overall assessment of treatment by patients at 52 weeks. Assessed using a verbal rating scale with 5 categories: Outstanding, very satisfactory, satisfactory, marginal and not satisfactory.|Up to 52 weeks|Per-protocol population||Percentage of participants|||Number
660718|NCT01853839|Secondary|Cardiovascular Events|Percentage of participants who experienced a major cardiovascular (CV) event|Up to 52 weeks|All subjects included in the study according to the study protocol i.e. patients who did not violate any inclusion or exclusion criteria||Percentage of participants|||Number
660719|NCT01853839|Secondary|Achieving JNC 7 Treatment Goals After Ramadan|The proportion of patients enrolled in the study who achieve the JNC 7 (the seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure) treatment goals (blood pressure (BP) <140/90 mmHg) in a primary-care setting after Ramadan. This variable was derived from the mean sitting blood pressure assessed by the investigators after Ramadan. To achieve JNC 7 treatment goals, the subject had to satisfy both blood pressure criteria - systolic blood pressure below 140 mm Hg and diastolic blood pressure below 90 mm Hg.|1 month|Per-protocol (PP) population which included all eligible patients who did not experience any protocol violation and were treated with the study medication up to week 52 (study completers) according to the prescribing information.||Percentage of participants|||Number
660720|NCT01853839|Primary|Achievement of the JNC 7 Treatment Goals (BP <140/90 mmHg) at Week 52|The proportion of patients enrolled in the study who achieve the JNC 7 (the seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure) treatment goals (blood pressure (BP) <140/90 mmHg) in a primary-care setting at week 52. This variable was derived from the mean sitting blood pressure assessed by the investigators at week 52. To achieve JNC 7 treatment goals, the subject had to satisfy both blood pressure criteria – systolic blood pressure below 140 mm Hg and diastolic blood pressure below 90 mm Hg.|Up to 52 weeks|ITT dataset which included all patients, who received at least one dose of study medication.||Percentage of participants|||Number
660721|NCT01853696|Secondary|Immunologic Graft Rejection Episode|Rejection episodes were assessed by slit lamp examination and categorized as definite when an endothelial rejection line was detected in a previously clear graft, probable when inflammation (stromal infiltrate, keratic precipitates, cells in the anterior chamber, or ciliary injection) was detected in a previously clear graft without an endothelial rejection line, and possible if central corneal pachymetry increased by 30 microns or more, even if the cornea was clear and no inflammation was detected by slit lamp examination.|within first year after cornea transplantation|||eyes|Participants||Number
660722|NCT01853696|Primary|Intraocular Pressure|Number of eyes in which the absolute intraocular pressure equaled or exceeded 24 mm Hg OR in which there was a relative increase of at least 10 mm Hg over the baseline preoperative reading.|from 1 to 12 months after transplant|||eyes|Participants||Number
660771|NCT01853072|Secondary|Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 60||Baseline to Day 60|Full analysis set||Percentage of participants|||Number
660724|NCT01853605|Primary|Investigator Satisfaction With Breast Implants on a 5-Point Scale|Investigator satisfaction with each breast implant is assessed on the following 5-point scale: (Definitely Satisfied, Somewhat Satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, and Definitely Dissatisfied). Satisfaction is reported for Investigator's assessing satisfaction as definitely satisfied and somewhat satisfied. The worst response is used if the Investigator reports different responses for the left and right breasts.|5 years|Evaluable population: all enrolled subjects implanted with the NATRELLE 410 original style implants, who completed the 5 year follow-up visit, and had data at the time point.||Subjects|||Number
660725|NCT01853605|Primary|Subject Satisfaction With Breast Implants on a 5-Point Scale|Subject satisfaction with each breast implant is assessed on the following 5-point scale: (Definitely Satisfied, Somewhat Satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, and Definitely Dissatisfied). Satisfaction is reported for subject's assessing satisfaction as definitely satisfied and somewhat satisfied. The worst response is used if the subject reports different responses for the left and right breasts.|5 years|Evaluable population: all enrolled subjects implanted with the NATRELLE 410 original style implants, who completed the 5 year follow-up visit, and had data at the time point.||Subjects|||Number
660726|NCT01853475|Secondary|Piperaquine AUC0-inf|Area under the Piperaquine plasma concentration time curve from time zero to time infinity using observed values.|Day 1 pre-dose and post-dose at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours(Day 2), and, 48 (Day 3), 72 (Day 4), 96 (Day 5),168 (Day 8), Day 11, Day 15, Day 29 and Day 43|Pharmacokinetic parameters were evaluated using all available concentration data from all 24 subjects who had received at least one treatment of randomised study medication.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
660727|NCT01853475|Secondary|Piperaquine Cmax|Piperaquine maximum concentration observed|Day 1 pre-dose and post-dose at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours(Day 2), and, 48 (Day 3), 72 (Day 4), 96 (Day 5),168 (Day 8), Day 11, Day 15, Day 29 and Day 43|Pharmacokinetic parameters were evaluated using all available concentration data from all 24 subjects who had received at least one treatment of randomised study medication.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
660728|NCT01853475|Primary|OZ439 AUC0-inf|Area under the OZ439 plasma concentration time curve from time zero to time infinity using observed values.|Day 1 pre-dose and post-dose at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours(Day 2), and, 48 (Day 3), 72 (Day 4), 96 (Day 5),168 (Day 8), Day 11, Day 15, Day 29 and Day 43|Pharmacokinetic parameters were evaluated using all available concentration data from all 24 subjects who had received at least one treatment of randomised study medication.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
660729|NCT01853475|Primary|OZ439 Cmax|OZ439 maximum concentration observed|Day 1 pre-dose and post-dose at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours(Day 2), and, 48 (Day 3), 72 (Day 4), 96 (Day 5),168 (Day 8), Day 11, Day 15, Day 29 and Day 43|Pharmacokinetic parameters were evaluated using all available concentration data from all 24 subjects who had received at least one treatment of randomised study medication.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
660730|NCT01853397|Secondary|Subject Satisfaction With Treatment|Subjects rated their satisfaction with treatment results using a 5-point Likert Satisfaction Scale (5: very satisfied; 4: satisfied; 3: neither satisfied nor dissatisfied; 2: dissatisfied; 1: very dissatisfied). The subject satisfaction score was analyzed as the proportion of subjects showing improvement as defined as a score of 4 or greater (‘satisfied’ or ‘very satisfied’).|4, 8, 12, and 16 weeks|Intent-to-treat||percentage of subjects satisfied|||Number
660731|NCT01853397|Secondary|Subject Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS)|Subjects self-assessed improvement in the treatment area and assigned a GAIS score at each visit. Scoring was based upon a five point grading System: 5 - Much Improved, 4 - Improved, 3 - No Change, 2 - Worse, or 1 - Much Worse. The definition of an improvement of the GAIS score included either a GAIS score of ‘Improved’ or ‘Much Improved’.|4, 8, 12, and 16 weeks|Intent-to-treat||percentage of subjects improved|||Number
660732|NCT01853397|Secondary|Investigator Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS)|"GAIS evaluations were performed by Investigators at the 4, 8, 12, and 16 week visits. Investigators used direct visual assessment (live assessment) compared to photographs of subjects taken before treatment (baseline) to assess improvement in the treatment area.
Scoring was based upon a five point grading System: 5 - Much Improved, 4 - Improved, 3 - No Change, 2 - Worse, or 1 - Much Worse. The definition of an improvement of the GAIS score included either a GAIS score of ‘Improved’ or ‘Much Improved’."|4, 8, 12, and 16 weeks|Intent-to-treat||Percentage of subjects improved|||Number
660733|NCT01853397|Secondary|Change in Waist Circumference 4,8, and16 Weeks After Treatment as Compared to Baseline|Change from baseline in waist circumference 4, 8, and 16 weeks after treatment was assessed by blinded evaluators.|4 weeks, 8 weeks, 16 weeks|Intent-to-treat||cm||Standard Deviation|Mean
660734|NCT01853397|Primary|Change in Waist Circumference 12 Weeks After Treatment as Compared to Baseline|Change from baseline in waist circumference 12 weeks after treatment was assessed by blinded evaluators.|12 weeks|Intent-to-treat||cm||Standard Deviation|Mean
660735|NCT01853384|Secondary|Change From Baseline in Pain Associated With the Target Leg at Each of the 12 Double Blind Treatment Weeks|Target leg pain were measured using a Visual Analog Scale [Range: 0mm – 100mm]. Subjects marked their pain level on a 100 mm horizontal line, with a short vertical line across the scale, 0 denoting no pain and 100mm the maximum pain.|Baseline and Weekly, over the 12 week treatment period|ITT Populations: Subjects who received at least one dose of test article. Data were analyzed by an ANCOVA, adjusted for site and baseline score.||mm||Standard Error|Least Squares Mean
660736|NCT01853384|Secondary|Change From Baseline in Pain Associated With the Target Wound at Each of the 12 Double Blind Treatment Weeks|Target ulcer pain was measured using a Visual Analog Scale [Range: 0mm – 100mm]. Subjects marked their pain level on a 100 mm horizontal line, with a short vertical line across the scale, 0 denoting no pain and 100mm the maximum pain.|Baseline and Weekly, over the 12 week treatment period|ITT Populations: Subjects who received at least one dose of test article. Data were analyzed by an ANCOVA, adjusted for site and baseline score.||mm||Standard Error|Least Squares Mean
660772|NCT01853072|Secondary|Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 90||Baseline to Day 90|Full analysis set||Percentage of participants|||Number
660874|NCT01850550|Secondary|Physical Activity|Assessed by the International Physical Activity Questionnaire|12 weeks after initial consent||||||
660737|NCT01853384|Secondary|Number of Subjects With Durable Wound Healing Over the 3 Months Following Complete Wound Closure|Subjects who completed the treatment period with confirmed wound closure were followed in the post-treatment period for a further two months to determine their closed wound status (remained closed/reopened), giving a measure of persistence of wound closure following completion of treatment.|Target ulcer status observed at two (visit 1) and three (visit 2) months following initial ulcer closure.|Due to study termination the data available to assess durability of closure were limited to only the subjects who completed at least one of the follow-up visits. Participants who had CLOSED wounds at completion of treatment; 103 subjects (HP802-247: 49; Vehicle: 54) completed Visit 18, 114 subjects (HP802-247: 57; Vehicle: 57) completed Visit 19||participants|||Number
660738|NCT01853384|Secondary|Compare the Treatment Groups for the Proportion of Subjects With Wound Closure at Each of the 12-Week Treatment Period From Baseline|For subjects who dropped from the study, their remaining visit values were imputed using LOCF. Treatment groups were compared for percentage of participants with closed wounds at each treatment visit.|Weekly, over the 12 week treatment period, or until wound closure, which ever occurred first|ITT Populations: Subjects who received at least one dose of test article. Analysis was by the Cochrane Mantel Haenszel (CMH) test, adjusted for sites, with significance being at P < 0.05||percentage of participants|||Number
660739|NCT01853384|Secondary|Compare the Efficacy of the Treatment Groups in Achieving Complete Wound Closure, Based on Median Time (Days) to Closure Over the 12-Week Treatment Period From Baseline.|This key secondary outcome was based on a Kaplan-Meier Survival analysis.|12 weeks|ITT Populations: Subjects who received at least one dose of test article. Data were analyzed using Kaplan-Meier Survival analysis, with significance being at P < 0.05.||days||95% Confidence Interval|Median
660740|NCT01853384|Secondary|Compare the Efficacy of the Treatment Groups in Achieving Complete Wound Closure, Based on Time in Days to Closure Over the 12-Week Treatment Period From Baseline.|This key secondary outcome was based on a Cox Proportional Hazard Analysis.|12 Weeks|ITT Populations: Subjects who received at least one dose of test article. Data were analyzed using the Cox Proportional hazard procedure, with significance being at P < 0.05.||days||Full Range|Median
660741|NCT01853384|Primary|Compare the Treatment Groups for the Number of Subjects With Complete Wound Closure Over the 12-Week Treatment Period From Baseline|"For each treatment group the area of each subject’s target ulcer was measured on a weekly basis, for up to 12 weeks, using a laser-based wound imaging system in conjunction with software to measure area. Following initial closure subjects returned for four weekly visits to confirm wound closure. Wounds that remained closed for four weeks were classified as confirmed closures; if a wound opened at any of the 4 visits it was not considered to have closed.
For subjects who dropped from the study prior to the end of treatment, their remaining visit values were imputed using LOCF; wound status of closed was not imputed."|Weekly, over 12 Weeks or until wound closure, which ever occurred first|ITT Populations: Subjects who received at least one dose of test article.||participants|||Number
660742|NCT01853371|Primary|Diastolic Blood Pressure After 4 Weeks||1 month|||mmHg||Standard Deviation|Mean
660743|NCT01853371|Secondary|Incidence of Wet Cupping Side Effects in Intervention Group|"Immediate side effects of wet cupping will be assessed through a checklist on the after each cupping session.
Delayed side effects of wet cupping will be assessed through another checklist after 1 month of the final hijama session."|1 month||||||
660744|NCT01853371|Primary|Systolic Blood Pressure After 4 Weeks||1 month|||mmHg||Standard Deviation|Mean
660745|NCT01853332|Secondary|Health Risk Factors|An index score of health behavior risk factors was created. Any amount of smoking, non-optimal drinking (≥ 7 drinks per week for women; ≥ 14 drinks per week for men), a score in the bottom tertile of the AHEI, and minimal exercise (< 6 metabolic hours per week) were considered risk factors, coded as “1”, and then tallied. The range of scores for health risk factors in the current sample was between 0 and 4 health risk factors (where 4 is more risk factors).|cross-sectional|||sum of health risk factors||Standard Deviation|Mean
660746|NCT01853332|Secondary|Body Mass Index (BMI)|BMI is calculated as weight in kilograms divided by height in meters squared.|cross-sectional|||kg/m^2||Standard Deviation|Mean
660747|NCT01853332|Primary|Social Adjustment Scale|The Social Adjustment Scale is a semi-structured interview assessing functioning in the preceding 2 months in domains of work (including employment functioning, homemaking and other household functions, and/or student/educational functioning), friendships/leisure, and relationships with extended family. If applicable, relationships with immediate family members (spouse/partner and/or children) are also assessed. The SAS is closely linked to mental health and can be used as a tool for assessing treatment response to psychotropic medications or therapies. Positive adjustment is the ability to carry out each activity/role effectively, deriving satisfaction/support from that domain, whereas poor adjustment reflects maladaptation, dissatisfaction, disengagement, and/or discord. Scores range from 1 (excellent adjustment) to 7 (very poor adjustment). Coding was completed during an audio-recorded interview; 12% were coded for agreement (91%).|2.5 years|||units on a scale||Standard Deviation|Mean
660748|NCT01853332|Primary|Psychosocial Health Risk Factors Correlated With BMI|Correlations of scales with BMI score. Cumulative adversity occurring before age 18 was assessed using a) the Evaluation of Lifetime Stressors, b) SCID, and c) the Adult Attachment Interview. A cumulative adversity sum score was obtained (range 0–13; higher is more adversity). An overall adversity score was created by multiplying the number of childhood adversities × the overall severity of childhood adversity × the overall chronicity of childhood adversity. Scores for overall adversity ranged from 0 to 156 (higher is more adversity). The Social Adjustment Scale is a semi-structured interview assessing functioning in the preceding 2 months and ranges from 1 (excellent adjustment) to 7 (very poor adjustment). Psychosocial risk factors is an index of 1 to 3 (higher is more risk). Health risk score adds smoking, non-optimal drinking (>7/14 drinks/week for women/men), a score in the bottom tertile of the AHEI, and minimal exercise (<6 hours/week)and tallied (scores0-4 with higher worse).|2.5 years|||Pearson Correlation Coefficients|||Number
660773|NCT01853072|Primary|Percentage of Participants Who Develop Macular Edema Within 90 Days Following Cataract Surgery (Day 0)|Macular edema was defined as ≥ 30% Increase from pre-operative baseline in central subfield macular thickness, as measured with Spectral Domain Ocular Coherence Tomography (SD-OCT). One eye (study eye) contributed to the analysis.|Day 0 to Day 90|Full analysis set||Percentage of participants|||Number
660875|NCT01850550|Secondary|Blood Pressure|Blood pressure will be recorded using an OMRON automatic blood pressure cuff.|12 weeks after initial consent||||||
660749|NCT01853332|Primary|Psychosocial Adversity|Cumulative adversity occurring before age 18 was assessed using a) the Evaluation of Lifetime Stressors, b) SCID, and c) the Adult Attachment Interview. A cumulative adversity sum score was obtained (range 0–13, higher more).An overall adversity score was created by multiplying the number of childhood adversities×the overall severity of childhood adversity × the overall chronicity of childhood adversity. Scores for overall adversity ranged from 0 (no) to 156 more adversity).The Social Adjustment Scale is a semi-structured interview assessing functioning in the preceding 2 months and ranges from 1 (excellent) to 7 (very poor adjustment). An index score of psychosocial risk factors was created. Education less than a Bachelor's degree, unemployment, and a social adjustment scale score indicative of non-optimal functiong (≥ 3) were considered risk factors, coded as “1”, and then tallied. Range of scores 0 (less)-3 (more risk).|2.5 years|||units on a scale||Standard Deviation|Mean
660750|NCT01853332|Primary|Hormonal Levels|"To assess clinically significant physical health outcomes including 1) establishing risk factors for CVD and type 2 diabetes mellitus (DM) 2) establishing novel risk factors for CVD and DM (e.g., inflammatory markers, hormonal mediators ), and 3) determining the prevalence of established CVD and DM.
Both insulin and glucose will be measured.
Adipokines.
Myokines.
Triglycerides and HDL cholesterol will be considered in light of their relevance to CVD.
Proinflammatory markers."|2.5 years|||ng/ml||Inter-Quartile Range|Mean
660751|NCT01853254|Primary|Percentage of Participants With at Least 1 Adverse Event||From Baseline to the end of the study (up to 72 weeks)|All participants analysis set.||Percentage of participants|||Number
660752|NCT01853215|Secondary|300mmHg Infusion Flow Rates|Measure the infusion flow rates attainable in the sternum when using intraosseous infusion of normal saline using a 300 mmHg infusion.|during the 12 minute infusion time frame|Per protocol||milliliters per hour||Standard Deviation|Mean
660753|NCT01853215|Secondary|200mmHg Infusion Flow Rates|Measure the infusion flow rates attainable in the sternum when using intraosseous infusion of normal saline using a 200 mmHg infusion.|during the 12 minute infusion time frame|Per protocol||milliliters per hour||Standard Deviation|Mean
660754|NCT01853215|Secondary|100mmHg Infusion Flow Rates|Measure the infusion flow rates attainable in the sternum when using intraosseous infusion of normal saline using a 100 mmHg infusion.|during the 12 minute infusion time frame|Per protocol||milliliters per hour||Standard Deviation|Mean
660755|NCT01853215|Secondary|Gravity Flow Rates|Measure the infusion flow rates attainable in the sternum when using intraosseous infusion of normal saline using a gravity infusion (no Pressure).|during the 12 minute infusion time frame|Per protocol||milliliters per hour||Standard Deviation|Mean
660756|NCT01853215|Secondary|Adhesion Strips|Perceived effeciveness of the device adhesion strips after application. A 1- 5 scale was used with 1=Poor; 2=Fair; 3=Good; $=Very good; 5=Excellent.|During insertion of the intraosseous needle set|||Likert scale||Standard Deviation|Mean
660757|NCT01853215|Secondary|Stability of Catheter Hub|Ability to stabilize the catheter hub and rotate the stylet for removal. 1 to 5 scale was used with 1=Very difficult; 2-Difficult; 3=Neutral; 4=Easy; 5=Very easy.|During insertion of the intraosseous needle set|||Likert scale||Standard Deviation|Mean
660758|NCT01853215|Secondary|Stability of Locator|"Operator's perceived stability of the sternal locator once placed on the subject.
1 to 5 scale was used with 1=Poor; 2=Fair; 3=Good; 4=Very good; 5=Excellent."|During insertion of the intraosseous needle set|Per protocol||Likert scale||Standard Deviation|Mean
660759|NCT01853215|Primary|Occurrences of Extravasation During Infusion|The number of occurrences of extravasation with intraosseous infusion as evidenced by contrast injection into the intraosseous catheter, visualized under fluoroscopic imaging.|during 12 minutes of infusion|Per protocol||participants|||Number
660760|NCT01853176|Primary|Pain Score, Visual Analogue Pain Scores|Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain. Patients will complete a log of pain levels experienced each morning and evening for 3 days. Score is 0-10 on a visual analog scale.|3 days||||||
660761|NCT01853085|Primary|IOP in the Study Eye at Week 12|IOP is a measurement of the fluid pressure inside the study eye.|Week 12|All patients with data for this outcome measure||mmHg||Standard Deviation|Mean
660762|NCT01853085|Secondary|Physician Assessment of Patient Compliance Compared to Previous Treatment on a 3-Point Scale|Physician assessment of patient compliance compared to previous therapy is assessed on a 3-point scale (better, equal, and worse). The numbers of patients in each category are presented.|12 Weeks|All patients with data for this outcome measure||Patients|||Number
660763|NCT01853085|Secondary|Number of Patients Who Continue Treatment|Patient continuation of treatment with Lumigan® UD after the end of study participation is assessed as Yes or No.|12 Weeks|All enrolled patients||Patients|||Number
660764|NCT01853085|Secondary|Number of Patients Who Discontinue Treatment With Lumigan® UD Prior to 12 Weeks of Treatment|Patient discontinuation of treatment with Lumigan® UD prior to 12 weeks of treatment is assessed as Yes or No.|12 Weeks|All enrolled patients||Patients|||Number
660765|NCT01853085|Secondary|Physician Assessment of Tolerability on a 4-Point Scale|Physician assessment of tolerability is assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented.|12 Weeks|All patients with data for this outcome measure||Patients|||Number
660766|NCT01853085|Secondary|Patient Assessment of Tolerability on a 4-Point Scale|Patient assessment of tolerability is assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented.|12 Weeks|All patients with data for this outcome measure||Patients|||Number
660767|NCT01853085|Secondary|Physician Assessment of IOP-Lowering Effect in the Study Eye on a 3-Point Scale|IOP is a measurement of the fluid pressure inside the eye. Physicians evaluate IOP change from baseline in the study eye as better than expected, as expected, and worse than expected. The numbers of patients in each category are presented.|Baseline, 12 Weeks|All patients with data for this outcome measure||Patients|||Number
660768|NCT01853085|Primary|Intraocular Pressure (IOP) in the Study Eye at Baseline|IOP is a measurement of the fluid pressure inside the study eye.|Baseline|All patients with data for this outcome measure||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
660769|NCT01853072|Secondary|Percentage of Participants With With a > 10-letter Loss in BCVA From Day 7 to Any Visit||Day 7 up to any visit through Day 90|Full analysis set||percentage of participants|||Number
660770|NCT01853072|Secondary|Percentage of Participants With a > 5-letter Loss in BCVA From Day 7 to Any Visit [Time Frame: Day 7 up to Any Visit]||Day 7 up to any visit through Day 90|Full analysis set||percentage of participants|||Number
660774|NCT01853072|Primary|Percentage of Participants With Best-corrected Visual Acuity (BCVA) Improvement of ≥ 15 Letters From Preoperative Baseline to Day 14 and Maintained Through Day 90|BCVA (with spectacles or other visual corrective devices) was reported in letters read correctly, using the Early Treatment Diabetic Retinopathy Study (ETDRS) test of 70 letters. Improvement of BCVA was defined as an increase (gain) in the number of letters read, compared to the baseline assessment. One eye (study eye) contributed to the analysis.|Baseline to Day 14, and maintained through Day 90|Full analysis set||Percentage of participants|||Number
660775|NCT01853046|Other Pre-specified|Tumor Response Assessment for Measurable Lesions According to RECIST, v1.1 (Response Evaluation Criteria in Solid Tumors)|"Positron emission tomography - computed tomography (ET-CT), CT, or magnetic resonance imaging (MRI) scans of all anatomic regions involved with the disease were performed to assess tumor response using the Response Evaluation Criteria in Solid Tumors, Version 1.1. (RECIST v1.1). Bone metastases were assessed by bone scintigraphy (bone scan). Tumor measurements and evaluation of tumor response were performed at baseline and within the last 7 days of Cycle 2. Thereafter, if subjects continued regorafenib treatment, tumor assessments were performed after every third cycle and at the end-of-treatment (EOT) visit. In addition, outcome of Assessment of Bone Metastases by Scintigraphy if Applicable (Bone Scan) was registered, the results of which has been reported as tumor response in this outcome as well."|Up to 6 months|Participants in the Normal/mild renal impairment group had only tumor assessments at screening, thus excluded from efficacy analysis.||participants|||Number
660776|NCT01853046|Secondary|AE,ur(10-24) Stage 2 for Metabolites M-7 and M-8|based on non-compartmental PK evaluation|Days 21-22: 10-24 hours|Participants with a valid pharmacokinetic profile for non compartmental analysis were reported.||percentage of dose||Standard Deviation|Mean
660777|NCT01853046|Secondary|AE,ur(0-10) Stage 2 for Metabolites M-7 and M-8|based on non-compartmental PK evaluation|Days 21-22: 0-10 hours|Participants with a valid pharmacokinetic profile for non compartmental analysis were reported.||percentage of dose||Standard Deviation|Mean
660778|NCT01853046|Secondary|AE,ur(10-24) Stage 1 ((Amount of Drug Excreted Via Urine During the Collection Interval 10–24 Hours Post Administration) for Metabolites M-7 and M-8|based on non-compartmental PK evaluation|Days 1-2: 10-24 hours|Participants with a valid pharmacokinetic profile for non compartmental analysis were reported.||percentage of dose||Standard Deviation|Mean
660779|NCT01853046|Secondary|AE,ur(0-10) Stage 1 (Amount of Drug Excreted Via Urine During the Collection Interval 0–10 Hours Post Administration) for Metabolites M-7 and M-8|based on non-compartmental PK evaluation|Days 1-2: 0-10 hours|Participants with a valid pharmacokinetic profile for non compartmental analysis were reported.||percentage of dose||Standard Deviation|Mean
660780|NCT01853046|Secondary|AE,ur(0-24)md (AE,ur(0-24) After Multiple-dose Administration) for Metabolites M-7 and M-8|based on non-compartmental PK evaluation|Days 21-22: 0-24 hours|Participants with a valid pharmacokinetic profile for non compartmental analysis were reported.||percentage of dose||Standard Deviation|Mean
660781|NCT01853046|Secondary|RLin (Linearity Factor Calculated as Ratio From AUC(0-24)md and AUC) for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5|Based on non-compartmental PK evaluation. RLin is the linearity factor of PK after multiple administrations of identical doses calculated as ratio of AUC(0-24)md and AUC.|Up to 25 days|Participants with a valid pharmacokinetic profile for non compartmental analysis were reported.||Linearity factor calculated as ratio||Geometric Coefficient of Variation|Geometric Mean
660782|NCT01853046|Secondary|RAAUC (Accumulation Ratio Calculated From AUC(0-24)md and AUC(0-24)) for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5|Based on non-compartmental PK evaluation. RAAUC calculated as ratio of AUC(0-24)md and AUC(0-24).|Up to 25 days|In Normal/mild renal impairment group, participants analyzed for regorafenib, M-2 and M-5 are n=13, 13 and 12 respectively. In Severe renal impairment group, participants analyzed for regorafenib, M-2 and M-5 are n=4, 4 and 3 respectively. Participants with a valid pharmacokinetic profile for non compartmental analysis were reported.||Accumulation Ratio||Geometric Coefficient of Variation|Geometric Mean
660783|NCT01853046|Secondary|RACmax (Accumulation Ratio Calculated From Cmax,md and Cmax) for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5|Based on non-compartmental PK evaluation. Accumulation ratio based on maximum plasma concentration (Cmax) was calculated as ratio of Cmax,md and Cmax.|Up to 25 days|Participants with a valid pharmacokinetic profile for non compartmental analysis were reported.||Accumulation Ratio||Geometric Coefficient of Variation|Geometric Mean
660784|NCT01853046|Secondary|Tlast,md (Tlast After Multiple-dose Administration) for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5|based on non-compartmental PK evaluation|Days 21-25: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 24, 48 and 96 hours post-dose|Participants with a valid pharmacokinetic profile for non compartmental analysis were reported.||h||Full Range|Median
660785|NCT01853046|Secondary|Tmax,md (Time to Reach Maximum Drug Concentration in Plasma After Multiple-dose Administration) for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5|based on non-compartmental PK evaluation|Days 21-25: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 24, 48 and 96 hours post-dose|Participants with a valid pharmacokinetic profile for non compartmental analysis were reported.||h||Full Range|Median
660786|NCT01853046|Secondary|AUC(0-tlast)md (AUC(0-tlast) After Multiple-dose Administration) for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5|based on non-compartmental PK evaluation.|Days 21-25: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 24, 48 and 96 hours post-dose|Participants with a valid pharmacokinetic profile for non compartmental analysis were reported.||mg*h/L||Geometric Coefficient of Variation|Geometric Mean
660787|NCT01853046|Secondary|Cmax,md (Cmax After Multiple-dose Administration) for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5|Based on non-compartmental PK evaluation.Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.|Days 21-25: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 24, 48 and 96 hours post-dose|Participants with a valid pharmacokinetic profile for non compartmental analysis were reported.||mg/L||Geometric Coefficient of Variation|Geometric Mean
660788|NCT01853046|Secondary|AUC(0-24)md ((AUC(0-24) After Multiple-dose Administration) for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5|Based on non-compartmental PK evaluation.|Days 21-25: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10 and 24 hours post-dose|In Normal/mild renal impairment group, number of participants analyzed is 13. In Severe renal impairment group, number of participants analyzed is 4. Participants with a valid pharmacokinetic profile for non compartmental analysis were reported.||mg*h/L||Geometric Coefficient of Variation|Geometric Mean
660789|NCT01853046|Secondary|Vz/F (Apparent Volume of Distribution During Terminal Phase After Single (First) Oral Administration) for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5|Based on non-compartmental PK evaluation.Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|Days 1-5: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 24, 48 and 96 hours post-dose|Participants with a valid pharmacokinetic profile for non compartmental analysis were reported.||L||Geometric Coefficient of Variation|Geometric Mean
660790|NCT01853046|Secondary|CL/F (Total Body Clearance of Drug After Extravascular Administration) After Single (First) Dose for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5|Based on non-compartmental PK evaluation.Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Days 1-5: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 24, 48 and 96 hours post-dose|Participants with a valid pharmacokinetic profile for non compartmental analysis were reported.||L/H||Geometric Coefficient of Variation|Geometric Mean
660791|NCT01853046|Secondary|t1/2 (Half-life Associated With the Terminal Slope) After Single (First) Dose for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5|Based on non-compartmental PK evaluation. t1/2 refers to the elimination of the drug. It is the time taken for the blood plasma concentration to reach half the concentration in the terminal phase of elimination. It is expressed in hours (h) and derived from the terminal slope of the concentration versus time curve.|Days 1-5: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 24, 48 and 96 hours post-dose|Participants with a valid pharmacokinetic profile for non compartmental analysis were reported.||h||Geometric Coefficient of Variation|Geometric Mean
660792|NCT01853046|Secondary|Tlast (Time of Last Data Point >LLOQ) After Single (First) Dose for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5|based on non-compartmental PK evaluation.|Days 1-5: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 24, 48 and 96 hours post-dose|||h||Full Range|Median
660793|NCT01853046|Secondary|Tmax (Time to Reach Maximum Drug Concentration in Plasma After Single (First) Dose) for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5|Based on non-compartmental PK evaluation.Tmax refers to the time after dosing when a drug attains its highest measurable concentration (Cmax). It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content.|Days 1-5: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 24, 48 and 96 hours post-dose|||h||Full Range|Median
660794|NCT01853046|Secondary|Cmax (Maximum Drug Concentration in Plasma After Single (First) Dose Administration) for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5|Based on non-compartmental PK evaluation.Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.|Days 1-5: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 24, 48 and 96 hours post-dose|||mg/L||Geometric Coefficient of Variation|Geometric Mean
660795|NCT01853046|Secondary|AUC(0-24) (AUC From Time Zero to 24 Hours p.a. After Single (First) Dose Administration) for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5|Based on non-compartmental PK evaluation. The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample; AUC(0-24) is defined as AUC divided from zero to 24 hours after single (first) dose.|Days 1-5: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10 and 24 hours post-dose|In Normal/mild renal impairment group, participants analyzed for regorafenib, M-2 and M-5 are n=18, 18, and 17 respectively. In Severe renal impairment group, participants analyzed for regorafenib, M-2 and M-5 are n=6, 6, and 5 respectively. Participants with a valid pharmacokinetic profile for non compartmental analysis were reported.||mg*h/L||Geometric Coefficient of Variation|Geometric Mean
660796|NCT01853046|Secondary|AUC (Area Under the Plasma Concentration vs. Time Curve From Zero to Infinity After Single (First) Dose) for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5|Based on non-compartmental PK evaluation. AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.|Days 1-5: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 24, 48 and 96 hours post-dose|Participants with a valid pharmacokinetic profile for non compartmental analysis were reported.||mg*h/L||Geometric Coefficient of Variation|Geometric Mean
660797|NCT01853046|Primary|AE,ur(0-24) (Amount of Drug Excreted Via Urine During the Collection Interval 0–24 Hours Post Administration) for Metabolites M-7 and M-8|Amount of drug excreted into urine during the collection interval 0-24 hours post dose was expressed as percentage of administered dose.|Days 1-2: 0-24 hours|Participants with a valid pharmacokinetic profile for non compartmental analysis were reported.||percentage of dose||Standard Deviation|Mean
660798|NCT01853046|Primary|AUC(0-tlast) [Area Under the Concentration-time Curve After Single (First) Dose From Time Zero to the Last Data Point >LLOQ (Lower Limit of Quantification)] for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5|Based on non-compartmental PK evaluation. The AUC(0-tlast) [Area Under the Concentration-time Curve After Single (First) Dose From Time Zero to the Last Data Point >LLOQ (Lower Limit of Quantification)] is a measure of systemic drug exposure from time 0 up to the time point at which the last measurable drug could be detectable, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.|Days 1-5: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 24, 48 and 96 hours post-dose|||mg*h/L||Geometric Coefficient of Variation|Geometric Mean
660799|NCT01852955|Secondary|Postoperative Pain in the Post Anesthesia Care Unit|Postoperative pain within the post anesthesia care unit after surgery. Area under the numeric rating scale for pain versus time curve in the post anesthesia care unit (score * min).Numeric rating scale for pain on a scale of 0-10 (0 is no pain and 10 is high pain) versus time curve in the post anesthesia care unit ( score * min). Area under a curve units of the horizontal axis multiplied by the units of the vertical axis. A higher value indicates more pain and time in the Post Anesthesia Care Unit.The range is 0 pain to x time in minutes x 1 hour to 5 hour ( 60-300 minutes) . The pain scores were collected at 15 minute intervals from the time of admission to the PACU. The area under the NRS pain scale versus time curve was calculated using the trapezoidal method as an indicator of pain burden during early recovery (Graph Pad Prism ver 5.03, Graph Pad Software INC.|Time in the post anesthesia care unit after surgery (average of 5 hours)|||(units on a scale * minutes||Inter-Quartile Range|Median
660802|NCT01852825|Secondary|Change From Baseline in Time Weighted Average (TWA) Over 1 Hour Pre-NAC Through 1 Hour Post-NAC Visual Analog Score (VAS) for Sneezing, Rhinorrhea, Congestion and Nasal Itch Following 12 Weeks of Treatment (Part 2)|A visual analog scale (VAS) representing the spectrum of symptoms from absent (0) to extremely severe (100) for each of rhinorrhea, nasal blockage, sneezing and nasal itch were summed to obtain an overall score. The range of VAS overall score is 0 - 400, with higher numbers representing worse symptoms. The models for the time-weighted mean (TWA) of the summed scores over 1 hour pre-NAC through hour 1 following NAC were constructed at the original scale.|Baseline and 12 weeks|All randomized participants from Part 2 who are compliant with the study procedures and have available data from at least one treatment. Participants from Part 1 were not analyzed because they were not treated with MK-8237 or placebo.||Score on a scale||95% Confidence Interval|Least Squares Mean
660803|NCT01852825|Secondary|Change From Baseline in 6.5 Hours Post-NAC Nasal Epithelial Eosinophil-related Messenger RNA (mRNA) Signature Following 12 Weeks of Treatment (Part 2)|Blood was collected from participants treated with D. pteronyssinus and D.farinae HDM and then with either MK-8237 or placebo, and the levels of nasal epithelial eosinophil-related mRNA signature 6.5 hours after NAC in serum at baseline and at week 12 were measured. The mRNA signature is derived from nine gene transcripts which were measured using the NanoString nCounter Gene Expression Assay. Positive control and pre-specified housekeeping gene normalization methods recommended by nSolver were used to normalize the transcripts. The average of the expression level of the nine genes was used to describe the eosinophil mRNA signature. Fold change from baseline and between-treatment comparison was evaluated based on cLDA method with log transformed data. Least squares geometric means are presented.|Baseline and 12 weeks|All randomized participants from Part 2 who are compliant with the study procedures and have available data from at least one treatment. Participants from Part 1 were not analyzed because they were not treated with MK-8237 or placebo.||Fold change||95% Confidence Interval|Least Squares Mean
660804|NCT01852825|Secondary|Change From Baseline in 6.5 Hours Post-NAC Interleukin-5 (IL-5) Protein Concentration in Nasal Exudates Following 12 Weeks of Treatment (Part 2)|Blood was collected from participants treated with D. pteronyssinus and D.farinae HDM and then with either MK-8237 or placebo, and the levels of Il-5 protein 6.5 hours after NAC in serum at baseline and at week 12 were measured. Fold change from baseline and between-treatment comparison was evaluated based on cLDA method with log transformed data. IL-5 protein concentration was measured in nasal exudates collected both pre- and post-nasal challenge. Least squares geometric means are presented.|Baseline and 12 weeks|All randomized participants from Part 2 who are compliant with the study procedures and have available data from at least one treatment. Participants from Part 1 were not analyzed because they were not treated with MK-8237 or placebo.||Fold change||95% Confidence Interval|Least Squares Mean
660805|NCT01852825|Primary|Change From Baseline in HDM-specific IgE Blocking Factor (IgE-BF) in Serum at 12 Weeks|Blood was collected from participants treated with D. pteronyssinus and D.farinae HDM and then with either MK-8237 or placebo, and the amount of IgE-BF in serum was measured based on an Ordinary IgE measurement and an assay in the presence of Competitors; with IgE-BF = 1 - (Competitive IgE/Ordinary IgE). This ranges from 0 (no IgE blocked) to 1 (all IgE blocked); and as it is based on a ratio there are no units. Change from baseline (12 weeks minus baseline) was evaluated based on cLDA method, and was analyzed based on the original scale. The model included time (categorical variable), treatment, and time by treatment interaction as fixed effects and participants as random effect. It is hypothesized that the change from baseline is statistically greater with MK-8237 treatment than with placebo. This hypothesis is supported if the lower bound of the 1-tailed 95% CI around the 12 week mean difference in change from baseline in HDM-specific IgE blocking factor response excludes zero.|Baseline and 12 weeks|All randomized participants from Part 2 who are compliant with the study procedures and have available data from at least one treatment. Participants from Part 1 were not analyzed because they were not treated with MK-8237 or placebo.||Ratio||95% Confidence Interval|Least Squares Mean
660806|NCT01852825|Primary|Change From Baseline in D. Pteronyssinus HDM-specific IgG4 Antibodies in Serum at 12 Weeks (Part 2)|Blood was collected from participants treated with D. pteronyssinus HDM, and then with MK-8237 or placebo, and the amount of HDM-specific IgG4 antibodies in serum at baseline and at week 12 were measured. Fold change from baseline was evaluated based on cLDA method with log transformed data. The model included time (categorical variable), treatment, and time by treatment interaction as fixed effects and participants as random effect. Least squares geometric means are presented. It is hypothesized that the change from baseline is statistically greater with MK-8237 treatment than with placebo. This hypothesis is supported if the lower bound of the two-sided 90% confidence interval for the geometric mean fold difference is >1.0.|Baseline and 12 weeks|All randomized participants from Part 2 who are compliant with the study procedures and have available data from at least one treatment. Participants from Part 1 were not analyzed because they were not treated with MK-8237 or placebo.||Fold Change||95% Confidence Interval|Geometric Mean
660807|NCT01852825|Primary|Change From Baseline in D. Farinae HDM-specific IgG4 Antibodies in Serum at 12 Weeks (Part 2)|Blood was collected from participants treated with Dermatophagoides (D.) farinae HDM and then with MK-8237 or placebo, and the amount of HDM-specific IgG4 antibodies in serum at baseline and at week 12 were measured. Fold change from baseline was evaluated based on constrained longitudinal data analysis (cLDA) method with log transformed data. The model included time (categorical variable), treatment, and time by treatment interaction as fixed effects and participants as random effect. Least squares geometric means are presented. It is hypothesized that the change from baseline is statistically greater with MK-8237 treatment than with placebo. This hypothesis is supported if the lower bound of the two-sided 90% confidence interval for the geometric mean fold difference is >1.0.|Baseline and 12 weeks|All randomized participants from Part 2 who are compliant with the study procedures and have available data from at least one treatment. Participants from Part 1 were not analyzed because they were not treated with MK-8237 or placebo.||Fold Change||95% Confidence Interval|Geometric Mean
660808|NCT01852812|Primary|Apparent Elimination Half-life (t1/2) of Montelukast CT and Montelukast OG|Blood samples for PK assessments were collected at either 1 h or 3 h post-dose on Day 1 and at either 14 h or 22 h post-dose on Day 28.|Up to Day 28 after first dose of study drug|The ASPE population consisted of all participants from the ASaT population who had an evaluable assessement for this PK parameter and did not have any protocol violation which would interfere with this PK parameter. Data for PK assessments were reported by dose of study drug received and age group.||Hours||Standard Deviation|Mean
660809|NCT01852812|Primary|Time to Cmax (Tmax) of Montelukast CT and Montelukast OG|Blood samples for PK assessments were collected at either 1 h or 3 h post-dose on Day 1 and at either 14 h or 22 h post-dose on Day 28.|Up to Day 28 after first dose of study drug|The ASPE population consisted of all participants from the ASaT population who had an evaluable assessement for this PK parameter and did not have any protocol violation which would interfere with this PK parameter. Data for PK assessments were reported by dose of study drug received and age group.||Hours||Standard Deviation|Mean
660810|NCT01852812|Primary|Maximum Plasma Concentration (Cmax) of Montelukast CT and Montelukast OG|Blood samples for PK assessments were collected at either 1 h or 3 h post-dose on Day 1 and at either 14 h or 22 h post-dose on Day 28.|Up to Day 28 after first dose of study drug|The ASPE population consisted of all participants from the ASaT population who had an evaluable assessement for this PK parameter and did not have any protocol violation which would interfere with this PK parameter. Data for PK assessments were reported by dose of study drug received and age group.||ng/mL||Standard Deviation|Mean
660811|NCT01852812|Primary|Area Under the Time-Concentration Curve (AUC 0-∞) of Montelukast CT and Montelukast OG|Blood samples for pharmacokinetic (PK) assessments were collected at either 1 hour (h) or 3 h post-dose on Day 1 and at either 14 h or 22 h post-dose on Day 28.|Up to Day 28 after first dose of study drug|The All Subjects Pharmacokinetically Evaluable (ASPE) population consisted of all participants from the ASaT population who had an evaluable assessement for this PK parameter and did not have any protocol violation which would interfere with this PK parameter. Data for PK assessments were reported by dose of study drug received and age group.||h*ng/mL||Standard Deviation|Mean
660812|NCT01852812|Primary|Percentage of Participants Who Discontinue Study Drug Due to an AE|An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a pre-existing condition that is temporally associated with the use of study drug is also an AE. Discontinuations due to an AE were reported based on the dose of study drug participants received.|Up to 12 weeks|The ASaT population consisted of all participants who received at least one dose of study drug. Data from the two montelukast 5 mg CT groups (6-9 year olds and 10-15 year olds) were pooled for safety analyses.||Percentage of participants|||Number
660813|NCT01852812|Primary|Percentage of Participants Who Experience at Least One Adverse Event (AE)|An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a pre-existing condition that is temporally associated with the use of study drug is also an AE. Participants were monitored for the occurrence of AEs for up to 14 days after last dose of study drug (up to a total of 14 weeks). AEs were reported based on the dose of study drug participants received.|Up to 14 days after last dose of study drug (Up to 14 weeks)|The All Subjects as Treated (ASaT) population consisted of all participants who received at least one dose of study drug. Data from the two montelukast 5 mg CT groups (6-9 year olds and 10-15 year olds) were pooled for safety analyses.||Percentage of participants|||Number
660814|NCT01852669|Primary|Number of Participants Who Are Stone Free at 3 Months|To compare the effectiveness of simultaneous adjunct controlled inversion therapy during extracorporeal shockwave lithotripsy (ESWL) to that of ESWL alone in the treatment of lower pole caliceal stone as measured by stone-free rate(SFR)|3 months|||participants|||Number
660815|NCT01852591|Secondary|CD8+CD107a+, Best Response Against Vaccine (CRM 197)|Best CD8+ response against CRM197 at day +30 for CD107a. Peripheral Blood Mononuclear Cells (PBMCs) were incubated with CRM197, or control. Cells were harvested and stained for flow cytometry.|30 Days Post Vaccine|All evaluable participants.||percentage of CD8 cells|||Number
660816|NCT01852591|Secondary|CD8+CTV-IFN-gamma+, Best Response Against Vaccine (CRM 197)|Best CD8+ response against CRM197 at day +30 after transplant, utilizing flow cytometry for interferon-γ (IFN-gamma). Peripheral blood mononuclear cells were stained with cell trace violet then incubated with CRM197 or vehicle control. Cells were then harvested and stained for flow cytometry. Highest percentage increase of CD8 cells from pre-vaccine to Day + 30.|30 Days Post Vaccine|All evaluable participants.||percentage of CD8 cells|||Number
660817|NCT01852591|Secondary|CD4+CTV-IFN-gamma+, Best Response Against Vaccine (CRM 197)|Best CD4+ response against CRM197 at day +30 after transplant, utilizing flow cytometry for interferon-γ (IFN-gamma). Peripheral blood mononuclear cells were stained with cell trace violet (CTV) then incubated with CRM197 or vehicle control. Cells were then harvested and stained for flow cytometry.|30 Days Post Vaccine|All evaluable participants.||percentage of CD4 cells|||Number
660818|NCT01852591|Primary|Number of Participants With Immune Response|Positive response per test category. Post-vaccination result higher than pre-vaccination values for each test category criteria. Additional details are reported under Secondary Outcome Measures.|30 Days Post Vaccine|All evaluable participants.||participants|||Number
660819|NCT01852383|Other Pre-specified|Maximum Duloxetine Oral Dose|Maximum duloxetine oral dose|Week 0, 1, 2, 4, 6, 8, 10, 12|||mg||Standard Deviation|Mean
660820|NCT01852383|Secondary|Change in Cornell Dysthymia Rating Scale Scores From Week 0 to Week 12|Cornell Dysthymia Rating Scale scores from range 0-64. Lower or decreasing scores represent decreased severity and a better outcome, while higher or increasing scores represent more severe depression and a worse outcome. The change score was calculated by subtracting the Week 12 score from the Week 0 score.|Week 0 and 12|||units on a scale||Standard Deviation|Mean
660821|NCT01852383|Other Pre-specified|Change in the Treatment Emergent Symptom Scale (TESS) Total Score From Week 0 to Week 12.|The Treatment Emergent Symptom Scale (TESS) documents the presence of common side effects. There are 26 items and the total score range is 0-26. Low scores or decrease in scores represent less side effects and high scores or increase in scores represent more side effects. The change in side effect severity scores was calculated by subtracting the Week 12 score from the Week 0 score.|0 and 12 weeks|||units on a scale||Standard Deviation|Mean
660876|NCT01850550|Secondary|BMI|Change in BMI from baseline to follow up will be assessed using a scale and stadiometer.|12 weeks after initial consent|||kg/m^2||Full Range|Mean
660877|NCT01850550|Primary|Percent Change in Weight|We will assess our participants to evaluate the percent change in weight over the 12 week period of the study using a scale.|12 weeks after initial consent|||percent weight change||Full Range|Mean
660878|NCT01850485|Secondary|SvO2|(venous oxygen saturation)|24 hours|||percent saturation||Standard Deviation|Mean
660822|NCT01852383|Primary|Change in Hamilton Rating Scale for Depression (HAM-D, 24-item) From 0 Weeks to 12 Weeks.|The research rater completed the 24-item Hamilton Rating Scale for Depression (HAM-D) and documented the scores on each visit. Hamilton Rating Scale for Depression scores range from 0-50 with low scores or decreasing scores representing decreased severity and better outcome, and higher scores or increasing scores representing more severe depressive symptoms and a worse outcome. The change score was calculated by subtracting the Week 12 score from the Week 0 score.|Screen (0) and 12 weeks|||units on a scale||Standard Deviation|Mean
660823|NCT01852214|Secondary|Platelet Reactivity Index|The comparison of the platelet reactivity index (PRI) values determined by vasodilator-stimulated phosphoprotein (VASP) between both treatments (ticagrelor or prasugrel). VASP was measured by quantitative flow cytometry using commercially available labelled monoclonal antibodies. A low PRI is indicative of high platelet inhibition.|2 hours|||PRI||95% Confidence Interval|Least Squares Mean
660824|NCT01852214|Secondary|Platelet Reactivity Index|The comparison of the platelet reactivity index (PRI) values determined by vasodilator-stimulated phosphoprotein (VASP) between both treatments (ticagrelor or prasugrel). VASP was measured by quantitative flow cytometry using commercially available labelled monoclonal antibodies. A low PRI is indicative of high platelet inhibition.|1 week|||PRI||95% Confidence Interval|Least Squares Mean
660825|NCT01852214|Secondary|P2Y12 Reaction Units|Comparison of the P2Y12 reaction units (PRU) values determined by VerifyNow between both treatments (ticagrelor or prasugrel)|2 hours|||PRU||95% Confidence Interval|Least Squares Mean
660826|NCT01852214|Primary|P2Y12 Reaction Units|The primary endpoint is the comparison of the P2Y12 reaction units (PRU) values determined by VerifyNow between both treatments (ticagrelor or prasugrel). Treatment effects were evaluated comparing PRU observed in the overall patient population after prasugrel treatment with those achieved after ticagrelor regardless of the sequence.|1 week|All analyses of platelet function conducted on all randomized subjects who received study drug, successfully completed at least one treatment period of the study and had valid data for the primary end point.||PRU||95% Confidence Interval|Least Squares Mean
660827|NCT01852175|Secondary|Platelet Reactivity Measured by Vasodilator-stimulated Phosphoprotein (VASP)|A secondary outcome was the comparison between groups of platelet reactivity index (PRI) measured by vasodilator-stimulated phosphoprotein (VASP) at 24 hours after loading dose.|24 hours|||PRI%||Standard Error|Least Squares Mean
660828|NCT01852175|Secondary|Platelet Reactivity Measured by Vasodilator-stimulated Phosphoprotein (VASP)|A secondary outcome was the comparison between groups of platelet reactivity index (PRI) measured by vasodilator-stimulated phosphoprotein (VASP) at 2 hours after loading dose.|2 hours|||PRI%||Standard Error|Least Squares Mean
660829|NCT01852175|Primary|Platelet Reactivity by Vasodilator-stimulated Phosphoprotein (VASP)|The primary end-point of the study was the comparison in the platelet reactivity index (PRI%) determined by vasodilator-stimulated phosphoprotein (VASP) at 1 week between prasugrel and ticagrelor.|1 week|||PRI%||Standard Error|Least Squares Mean
660830|NCT01852162|Secondary|Clot Kinetic: Clot Stength|Clot strength (maximal amplitude:MA) was assessed by thromboelastography.|1-week|Clot kinetic assessed by citrated-kaolin thromboelastography||mm||Standard Deviation|Mean
660831|NCT01852162|Secondary|Clot Kinetic: Thrombin Activity|Parameters related to thrombin activity and velocity of thrombus generation (reaction time: R; time to maximum rate of thrombus generation: TMRTG) were evaluated by thromboelastography.|1-week|Clot kinetic assessed by citrated-kaolin thromboelastography||minutes||Standard Deviation|Mean
660832|NCT01852162|Secondary|Platelet Reactivity Measured by Multiple Electrode Aggregometry.|Multiple measures of platelet reactivity evaluating purinergic and non-purinergic signaling pathways were assessed by multiple electrode aggregometry.|1-week|Platelet aggregation measured by multiple electrode aggregometry.||arbitrary aggregation units||Standard Deviation|Mean
660833|NCT01852162|Secondary|Platelet Reactivity Measured by LTA|Multiple measures of platelet reactivity evaluating purinergic and non-purinergic signaling pathways were assessed by light transmittance aggregometry (LTA).|1-week|Platelet aggregation measured by LTA||percentage of aggregation||Standard Deviation|Mean
660834|NCT01852162|Primary|TRAP-induced Platelet Aggregation|TRAP-induced platelet aggregation measured by light transmittance aggregometry (LTA) was similar between groups|1 week|TRAP-induced platelet aggregation||percentage of aggregation||Standard Deviation|Mean
660835|NCT01852019|Secondary|Bleeding Events in Accordance With the GUSTO Scale|Bleeding was assessed by history, physical exam, and complete blood count (CBC) that was performed on study Days 1 and 8. Reports of bleeding were to be evaluated by performance of a CBC. Bleeding was to be reported as recommended and quantified in accordance with the GUSTO criteria [The GUSTO Investigators, 1993].|Day 1 through Day 8|||participants|||Number
660836|NCT01852019|Secondary|Extent of Preservation of Inhibitory Effect of Cangrelor Treatment After Prasugrel, Compared to Treatment With Cangrelor Alone|A reference point for the inhibitory effect of cangrelor alone was chosen for comparison and designated the first draw during the cangrelor infusion (1.0 or 1.5 hours) or within 5 minutes post cangrelor infusion on Day 1. The extent of aggregation was observed during the cangrelor infusion on Day 8, either 24 or 48 hours after discontinuation of prasugrel as assessed by platelet reaction units (PRU) from the VerifyNow P2Y12 assay.|Day 8 - at 1.0 and 2.0 hours after initiation of cangrelor infusion|Subjects treated with cangrelor and prasugrel were used for the analysis and presentation of data.||platelet reaction units (PRU)||Standard Deviation|Mean
660837|NCT01852019|Secondary|Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint)|A reference point for the effect of prasugrel alone was chosen for comparison and designated the final draw on study Day 1 (3.5 or 4.0 hours after cangrelor had been discontinued) as the reference for the effect of prasugrel. The extent of aggregation in the presence of absence of the study drugs was examined for each of the endpoints as assessed by platelet reaction units (PRU) from the VerifyNow P2Y12 assay.|Day 1 measures taken at timepoints after cangrelor infusion end to end of Day 1 measures.|Subjects treated with cangrelor and prasugrel were used for the analysis and presentation of data.||platelet reaction units (PRU)||Standard Deviation|Mean
660879|NCT01850485|Secondary|Lactate|lactate levels in serum|24 hours|||mmol/l||Standard Deviation|Mean
660880|NCT01850485|Secondary|Cardiac Index|Cardiac Index is cardiac output indexed for body weight|24 hours|||L/m2||Standard Deviation|Mean
660881|NCT01850485|Secondary|Inotropes and Vasopressor Dose||baseline|||mcg/kg/min||Inter-Quartile Range|Median
660882|NCT01850485|Secondary|Fluid Balance After 24 Hours||24 hours|||liters||Standard Deviation|Mean
660838|NCT01852019|Primary|Extent of Preservation of Inhibitory Effect of Cangrelor Treatment After Prasugrel, Compared to Treatment With Cangrelor Alone|A reference point for the inhibitory effect of cangrelor alone was chosen for comparison and designated the first draw during the cangrelor infusion (1.0 or 1.5 hours) or within 5 minutes post cangrelor infusion on Day 1. The extent of aggregation was observed during the cangrelor infusion on Day 8, either 24 or 48 hours after discontinuation of prasugrel using light transmittance aggregometry (LTA) and expressed as % aggregation in response to 20 μM adenosine diphosphate (ADP) at 300 seconds (final/terminal aggregation response).|Day 8 - at 1.0 and 2.0 hours after initiation of cangrelor infusion|Subjects treated with cangrelor and prasugrel were used for the analysis and presentation of data.||% aggregation||Standard Deviation|Mean
660839|NCT01852019|Primary|Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint)|A reference point for the effect of prasugrel alone was chosen for comparison and designated the final draw on study Day 1 (3.5 or 4.0 hours after cangrelor had been discontinued) as the reference for the effect of prasugrel. The extent of aggregation in the presence or absence of the study drugs was examined for each of the endpoints using light transmittance aggregometry (LTA) and expressed as % aggregation in response to 20 micromolar (μM) adenosine diphosphate (ADP) at 300 seconds (final/terminal aggregation response).|Day 1 measures taken at timepoints after cangrelor infusion end to end of Day 1 measures.|Subjects treated with cangrelor and prasugrel were used for the analysis and presentation of data.||% aggregation||Standard Deviation|Mean
660840|NCT01851876|Primary|Clinical Pregnancy Rate||4 months|||participants|||Number
660841|NCT01851876|Primary|Clinical Pregnancy Rate||up to 6 months||||||
660842|NCT01851863|Other Pre-specified|Number of Participants With Adverse Reaction|Number of participants with adverse reactions were recorded to analyze the safety profile of treatment.|8 weeks|||participants|||Number
660843|NCT01851863|Secondary|Change From Baseline in Psychiatric Symptom on Hospital Anxiety and Depression Scale at Week 8|Each patient was surveyed using the Hospital Anxiety and Depression Scale to assess the psychiatric symptom at week 0 and 8.The HADS consists of 14 items, seven of which assess anxiety, and seven assess depression. The anxiety and depression subscales were calculated independently. The patients were asked to answer each item on a four-point (0 - 3) scale. Scores of 0 to 7 on either subscale can be regarded as within the normal range, scores of 8 to 10 are suggestive of the presence of the respective state, and scores of 11 or higher indicate the probable presence of the respective mood disorder. The change of HADS scores was calculated by HADS anxiety and depression scores of 8 weeks minus baseline, with lower values indicate better outcome.|week 0 and 8|||units on HADS score||Full Range|Mean
660844|NCT01851863|Secondary|Change From Baseline in Dyspepsia Symptom Questionnaire at Week 8|The severity of patients’ dyspeptic symptoms were assessed using the Leeds Dyspepsia Questionnaire (LDQ) at week 0 and 8. The LDQ contains eight items about epigastric pain, retro-sternal pain, regurgitation, nausea, vomiting, belching, early satiety and dysphagia with six grades for each item and a sum of the eight symptom scores make the LDQ score.LDQ scores of 0 - 4 were classified as very mild dyspepsia, 4 - 8 as mild dyspepsia, 9 -15 as moderate dyspepsia, and > 15 as severe or very severe dyspepsia. The change of LDQ scores was calculated by LDQ scores of 8 weeks minus baseline, with lower values represent a better outcome.|week 0 and 8|||units on LDQ scale||Full Range|Mean
660845|NCT01851863|Primary|Compliance of Flupentixol-Melitracen|The patients were asked to keep a diary to record their medication intake. At each visit (weeks 1, 2, 4, 8), the patient bring back the drug bottle and the diary, then the physician recorded the number of pills remaining in the bottle. Pills remained more than 20% at any visit or seven days of consecutive abstinence were adopted as the criterion for identifying therapy noncompliance.|weeks 1, 2, 4, 8|||participants|||Number
660846|NCT01851772|Other Pre-specified|Frequency of Adverse Events in Participants (i.e.Safety)|To assess occurrence rate of radiation toxicities through three (3) months of follow-up.|3 months post-Study Exit|||participants|||Number
660847|NCT01851772|Secondary|Device Performance|Number of subjects who received complete delivery of the brachytherapy treatment using the Xoft Electronic Brachytherapy System with the cervical applicator.|Study Exit (90 days)|||participants|||Number
660848|NCT01851772|Primary|Safety|Adverse event rate and severity during and following the administration of brachytherapy treatment, through discharge from the treatment facility, and for 3 months after treatment.|Study Exit (90 days)|Diagnosis of locally advanced cervical cancer (Stages Ib2-IVA).||percentage of participants and severity|||Number
660849|NCT01851720|Primary|Acute Pain Following Sub-Arachnoid Hemorrhage (SAH) is the Primary Outcome Variable and Will be Assessed Using the Numeric Rating Scale (NRS).|Pain score 0-10. 0 represented no pain and 10 worst pain|4 days|Though one subject in the PCA arm completed enrollment, we had insufficient data to perform any comparative analysis. We do no intend to summarize the patient's results.|||||
660850|NCT01851655|Other Pre-specified|Change in Anterior Knee Laxity|Anterior knee laxity will be assessed with a knee arthrometer and a maximum manual pull. The side-to-side difference will be recorded in mm. The change will be computed as (post-intervention difference minus pre-intervention difference).|Baseline (pre-intervention) to 9 weeks (post-intervention)|||mm||Standard Deviation|Mean
660851|NCT01851655|Other Pre-specified|Change in Fear of Movement/Re-injury|The 11-item version of the Tampa Scale for Kinesiophobia will be used to assess kinesiophobia or fear of movement/re-injury. Scores range from 11 to 44 points, and higher scores equal higher fear of movement/re-injury. Responses will be recorded on hard-copy and entered into a spreadsheet to calculate the score. The change will be computed as (post-intervention score minus pre-intervention score).|Baseline (pre-intervention) to 9 weeks (post-intervention)|||units on a scale||Standard Deviation|Mean
660852|NCT01851655|Other Pre-specified|Change in Quadriceps Strength|Knee extensor torque will be measured with an isokinetic dynamometer. The lever arm will move at 60 degrees/second. The peak torque from 5 trials will be obtained and normalized to body weight. The change will be computed as (post-intervention value minus pre-intervention value)|Baseline (pre-intervention) to 9 weeks (post-intervention)|||ft-lb/lb||Standard Deviation|Mean
660883|NCT01850485|Secondary|RincStO2|tissue oxygenation measured by Near Infrared Spectroscopy|baseline|||percent saturation||Standard Deviation|Mean
660884|NCT01850485|Primary|Microvascular Flow Index (MFI)|Microvascular Flow Index; minimum score = 0 (= no flow) and maximum score = 3 (=normal flow)|baseline measurement|||units on a scale||Inter-Quartile Range|Median
660853|NCT01851655|Secondary|Change in the Ratio of Urinary CTXII to Serum CPII Concentrations.|CTX-II is a biomarker of Type II articular cartilage degradation. Type II collagen carboxy propeptide (CPII) is a biomarker of Type II collagen synthesis. Early morning urine and blood samples will be collected pre- and post-treatment. Urinary CTX-II will be analyzed as described in Primary Outcomes. Serum CPII will be determined using enzyme-linked immunosorbent assay. Values of both biomarkers will be log-transformed, and the ratio of CTXII:CPII will be calculated. The change will be computed as (post-intervention CTXII:CPII values minus pre-intervention CTXII:CPII value).|Baseline (pre-intervention) to 9 weeks (post-intervention)|||log [(ng/mmol)/(ng/mL)]||Standard Deviation|Mean
660854|NCT01851655|Secondary|Change in Vertical Jump Height.|Vertical jump height will be assessed with the Vertex. The average of three trials will be recorded in cm. The change in vertical jump height will be computed as (post-intervention value minus pre-intervention value).|Baseline (pre-intervention) to 9 weeks (post-intervention)|||cm||Standard Deviation|Mean
660855|NCT01851655|Primary|Change in Urinary Concentrations of the C-terminal Crosslinking Telopeptide of Type II Collagen (CTX-II)|CTX-II is a biomarker of Type II collagen degradation. Early morning, second-void urine samples will be collected and stored. Concentrations of CTX-II will be determined with enzyme-linked immunosorbent assay and corrected for creatinine concentration, which will also be determined with enzyme-linked immunosorbent assay. Values will be log-transformed. The change in urinary CTX-II concentration will be computed as (post-intervention value minus pre-intervention value).|Baseline (pre-intervention) to 9 weeks (post-intervention)|||log-scale transformed value of ng/mmol||Standard Deviation|Mean
660856|NCT01851655|Primary|Change in International Knee Documentation Committee (IKDC) Subjective Form Score.|The IKDC subjective form is a measure of self-reported knee function. It includes items related to symptoms and functional activities. Scores range from 0 to 100 points, and higher scores equal higher function. Responses will be recorded on hard-copy and entered into a spreadsheet to calculate the score. The change will be computed as (post-intervention score minus pre-intervention score).|Baseline (pre-intervention) to 9 weeks (post-intervention)|||units on a scale||Standard Deviation|Mean
660857|NCT01851590|Secondary|Compliance to the Treatment|Evaluation of compliance was based on patient self-reports of whether the treatment protocol was followed 100% (complete), 80% (good), 60% (moderate), or 40% (poor) of the time.|At 4-month time-point|Percentage describes the proportion of patients who declared that they have been followed the instructions completely (100%).||percentage of participants|||Number
660858|NCT01851590|Secondary|Cost-effectiveness 2|Cost analysis was based on the retail price (€) and consumption of a 10 ml bottle of Abicin® 30% resin lacquer, a 5 ml bottle of Loceryl® 5% amorolfine lacquer, and 98 tablets of generic 250 mg terbinafine, sold by the University Pharmacy in Helsinki, Finland, January 2014. The cost was expressed as the average treatment cost per patient; for the total cost, this average was extrapolated to the entire study treatment arm. The results show the treatment costs (€) during the treatment period per patient in each group.|At 10-month time-point|||Euros (€)||95% Confidence Interval|Mean
660859|NCT01851590|Secondary|Cost-effectiveness 1|Cost analysis was based on the retail price (€) and consumption of a 10 ml bottle of Abicin® 30% resin lacquer, a 5 ml bottle of Loceryl® 5% amorolfine lacquer, and 98 tablets of generic 250 mg terbinafine, sold by the University Pharmacy in Helsinki, Finland, January 2014. The cost was expressed as the average treatment cost per patient; for the total cost, this average was extrapolated to the entire study treatment arm. The results show the treatment costs (€) per day per patient in each group.|At 10-month time-point|||Euros (€)||95% Confidence Interval|Mean
660860|NCT01851590|Secondary|Clinical Responses to the Treatments|Clinical responses to treatment were based on the proximal linear growth of healthy nail; thus, the clinical responses were classified as partial (evident proximal linear growth of healthy nail) or complete. Partial responses were defined as significant reductions in onycholysis, subungual hyperkeratosis, and streaks. A complete response was a fully normal appearance of the toenail.|At 4- and 10 months time-points from the beginning of the study.|Intention-to-treat population, last observation carried forward.||percentage of participants|||Number
660861|NCT01851590|Primary|Mycological Cure|To analyze the rate of complete mycological cure i.e. fungal eradication in terms of negative mycological culture AND negative potassium hydroxide (KOH) stain at 4- and 10 months time-points from the beginning of the study.|At 4- and 10 months time-points from the beginning of the study.|Primary and secondary outcome analyses were based on the intent-to-treat (ITT) population and missing values were imputed using the last observation carried forward (LOCF) method.||Percentage of participants||95% Confidence Interval|Number
660862|NCT01851330|Secondary|Percentage of Participants Experiencing Virologic Failure|"Virologic failure was defined as on-treatment virologic failure or virologic relapse.
On-Treatment Virologic Failure was defined as
Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment) Virologic relapse was defined as confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Baseline to posttreatment Week 24|Full Analysis Set||percentage of participants|||Number
660863|NCT01851330|Secondary|Change From Baseline in HCV RNA at Week 8||Baseline; Week 8|Participants in the Full Analysis Set with Available Data were analyzed.||log10 IU/mL||Standard Deviation|Mean
660864|NCT01851330|Secondary|Change From Baseline in HCV RNA at Week 4||Baseline; Week 4|Participants in the Full Analysis Set with Available Data were analyzed.||log10 IU/mL||Standard Deviation|Mean
660865|NCT01851330|Secondary|Change From Baseline in HCV RNA at Week 2||Baseline; Week 2|Participants in the Full Analysis Set with Available Data were analyzed.||log10 IU/mL||Standard Deviation|Mean
660866|NCT01851330|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 8||Week 8|Participants in the Full Analysis Set with Available Data were analyzed.||percentage of participants|||Number
660867|NCT01851330|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 4||Week 4|Participants in the Full Analysis Set with Available Data were analyzed.||percentage of participants|||Number
660868|NCT01851330|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 2||Week 2|Participants in the Full Analysis Set with Available Data were analyzed.||percentage of participants|||Number
660885|NCT01850394|Primary|Total Hemoglobin Loss|Total hemoglobin loos measured by difference between hemoglobin preoperatively and the fourth postoperative day|5 days after surgery|Use intention-to-treat analysis||g/dL||Standard Deviation|Mean
660886|NCT01850394|Secondary|Number of Patients Having Postoperative Complications|"Postoperative complications were measured as an incidence of the following complications;
wound hematoma
surgical site infection
systemic infection
deep vein thrombosis
pulmonary embolism
knee stiffness requiring manipulation
medical complication such as myocardial infarction, congestive hear failure"|postoperative 1-year period|Using Intention-to-treat analysis||participants|||Number
660887|NCT01850394|Secondary|Number of Patients Required Blood Transfusion||postoperative period (5 days after surgery)|||participants|||Number
660888|NCT01850394|Secondary|Knee Function Scores|"Knee function score was measured with 2 methods, and were evaluated preoperatively and then postoperatively at 3-month, 6-month, and 1-year period.
Knee Society Knee Score using for rating knee function measurement and subdivided into two parts; knee score and function score 1.1. Knee score : calculated from pain, presence of deformity, total range of flexion, alignment, and stability. Total score is 100 (0-100), more score means better.
1.2. Function score : calculated from patient’s ability to walk and climb stairs. The score ranges from 0-100, more score means better.
Western Ontario and McMaster Universities Arthritis Index or WOMAC score : a widely used, standardized questionnaires for evaluating the condition of patients with knee osteoarthritis, including pain (score = 0-20), stiffness (0-8), and functional limitation (0-68). Total score ranges from 0-68, lower score means better."|1 year after surgery|Using intention-to-treat analysis||units on a scale||Standard Deviation|Mean
660889|NCT01850394|Primary|Perioperative Blood Loss|"Drainage blood loss measured by accumulating total drainage volume postoperatively
Calculated total blood loss measured by using specific formula and difference between hematocrit preoperatively and the fourth postoperative day"|5 days after surgery|Using intention-to-treat analysis||ml||Standard Deviation|Median
660890|NCT01849848|Secondary|Number of Abnormalities (Grade ≥3) in Laboratory Test Values|Abnormalities in laboratory test values in overall study period were analyzed. Severity of abnormalities were evaluated using Common Terminology Criteria for Adverse Events (CTCAE). grade 1 : mild, grade 2 : moderate, grade 3 : severe or medically significant but not immediately life-threatening grade, 4 : life threatening or disabling grade, 5 : death related to adverse event|up to around 44 weeks|||Events|||Number
660891|NCT01849848|Secondary|Number of Subjects With Abnormality (Grade ≥3) in Laboratory Test Values|Abnormalities in laboratory test values in overall study period were analyzed. Severity of abnormalities were evaluated using Common Terminology Criteria for Adverse Events (CTCAE). grade 1 : mild, grade 2 : moderate, grade 3 : severe or medically significant but not immediately life-threatening grade, 4 : life threatening or disabling grade, 5 : death related to adverse event|up to around 44 weeks|||participants|||Number
660892|NCT01849848|Secondary|Adverse Events|All adverse events occurring during the administration of the investigational product are to be examined for safety by cross tabulation lists and tables of incidence from the viewpoint of relationship with the drug, disease severity and medicine treated group.|up to around 44 weeks|||participants|||Number
660893|NCT01849848|Secondary|Overall Survival (OS)|Using the registration date as the start date, OS with death, regardless of the cause, as events, are to be summarized using the Kaplan-Meier estimator and the 50% point according to the Greenwood's formula and 95% confidence interval are to be calculated.|up to around 44 weeks|||Days||95% Confidence Interval|Median
660894|NCT01849848|Secondary|Duration of Response (DOR)|From initial response (PR or higher), DOR with relapse/recurrence or progression, and death, regardless of cause, as events, are to be summarized using the Kaplan-Meier estimator and the 50% point according to the Greenwood's formula and 95% confidence interval are to be calculated.|up to around 44 weeks|||Days||95% Confidence Interval|Median
660895|NCT01849848|Secondary|Time to Treatment Failure (TTF)|Using the registration date as the start date, TTF with relapse/recurrence or progression, death regardless of the cause, and early discontinuation of treatment as events are to be summarized using the Kaplan-Meier estimator and the 50% point according to the Greenwood's formula and 95% confidence interval are to be calculated.|up to around 44 weeks|||Days||95% Confidence Interval|Median
660896|NCT01849848|Secondary|Progression-Free Survival (PFS)|Using the registration date as the start date, PFS with relapse/recurrence or progression, and death regardless of the cause as events are to be summarized using the Kaplan-Meier estimator and the 50% point according to the Greenwood's formula and the 95% confidence interval are to be calculated.|up to around 44 weeks|||Days||95% Confidence Interval|Median
660897|NCT01849848|Secondary|Response Rate (CR+PR) Based on the Blade Criteria|"The criteria for PR based on the Blade are shown below.
PR requires 1. or all of the others:
Some, but not all, of the criteria for CR are fulfilled
≥50% reduction in the level of the serum monoclonal paraprotein, maintained for a minimum of 6 weeks
Reduction in 24 h urinary light chain excretion either by ≥90% or to <200 mg, maintained for a minimum of 6 weeks
For patients with non-secretory myeloma only, ≥50% reduction in plasma cells in a bone marrow aspirate and on trephine biopsy
≥50% reduction in the size of soft tissue plasmacytomas
No increase in size or number of lytic bone lesions"|up to around 44 weeks|||percentage of paticipants||95% Confidence Interval|Number
660898|NCT01849848|Secondary|Complete Response (CR) Based on the Blade Criteria|"The criteria for CR based on the Blade are shown below.
CR requires all of the followings:
Absence of the original monoclonal paraprotein in serum and urine by immunofixation, maintained for a minimum of 6 weeks
<5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy
No increase in size or number of lytic bone lesions
Disappearance of soft tissue plasmacytomas"|up to around 44 weeks|||percentage of paticipants||95% Confidence Interval|Number
660899|NCT01849848|Secondary|Response Rate (sCR+CR) Based on IMWG Criteria||up to around 44 weeks|||percentage of paticipants||95% Confidence Interval|Number
660900|NCT01849848|Primary|Response Rate [Stringent CR (sCR)+Complete Response (CR)+Very Good PR (VGPR)+Partial Response (PR)]Based on International Myeloma Working Group (IMWG) Criteria|"The criteria for sCR, CR, VGPR, and PR based on IMWG are shown below.
sCR: Fulfills CR criteria as well as all of the following conditions
Normal free light chain (FLC) ratio(κ/λ)
Disappearance of clonal cells in bone marrow by immunohistochemistry or immunofluorescence
CR: Fulfills all of the following criteria
Negative immunofixation of serum and urine M-protein
<5% plasma cells in bone marrow
Disappearance of any soft tissue plasmacytoma
VGPR: Fulfills at least one of the following criteria
Serum and urine M-protein detectable by immunofixation but not electrophoresis
≥90% reduction in serum M-protein and 24-hour M-protein excretion amount in urine <0.1 g/24 hour
PR: Fulfills the following criteria
≥50% reduction in serum M-protein, and ≥90% reduction in urine M-protein, urine M-protein excretion amount is reduced to < 0.2 g/24hours"|up to around 44 weeks|||percentage of paticipants||95% Confidence Interval|Number
660902|NCT01849770|Secondary|Mean Pain Severity|"At the Baseline Visit, subjects will be asked to recount the maximum intensity experienced with a muscle cramp in the previous 24 hours and the maximum intensity experienced with a muscle cramp in the previous 30 days.
The visual analog scale (VAS) will be used to measures pain associated with muscle cramping. It will be used to measure muscle cramp intensity in this study. The scale rating is from 0-10; 0 equals no symptoms, 10 equals most severe symptoms.
Subject will be provided with a muscle cramp diary to record muscle cramp intensity at home, daily."|Weeks 3-12, post titration of study medication|||units on a scale||95% Confidence Interval|Mean
660903|NCT01849770|Secondary|Maximal Pain Severity - Ratios for Comparisons of Doses for Weeks 3-12||Week 3-12, post titration of study medication|||ratio||95% Confidence Interval|Number
660904|NCT01849770|Secondary|Cramp Frequency - Ratios for Comparisons of Doses for Weeks 3-12||Week 3-12, post titration of study medication|||ratio||95% Confidence Interval|Number
660905|NCT01849770|Secondary|Maximal Pain Severity|"At the Baseline Visit, subjects will be asked to recount the maximum intensity experienced with a muscle cramp in the previous 24 hours and the maximum intensity experienced with a muscle cramp in the previous 30 days.
The visual analog scale (VAS) will be used to measures pain associated with muscle cramping. It will be used to measure muscle cramp intensity in this study. The scale rating is from 0-10; 0 equals no symptoms, 10 equals most severe symptoms.
Subject will be provided with a muscle cramp diary to record muscle cramp intensity at home, daily."|Weeks 3-12, post titration of study medication|||units on a scale||95% Confidence Interval|Mean
660906|NCT01849770|Other Pre-specified|Change in Slow Vital Capacity (SVC) Score|The vital capacity (VC) (percent of predicted normal) will be determined, using the slow VC method. The SVC can be measured using conventional spirometers that have had a calibration check prior to subject testing. A printout from the spirometer of all SVC trials will be retained.|Week 0, Week 6, and Week 12 (or Early Termination Date)|||percent of predicted normal||95% Confidence Interval|Mean
660907|NCT01849770|Other Pre-specified|Change in ALS Functional Rating Scale- Revised (ALSFRS-R) Score|The ALSFRS-R is a quickly administered (5 minutes) ordinal rating scale (ratings 0-4) used to determine subjects' assessment of their capability and independence in 12 functional activities. All 12 activities are relevant in ALS. Initial validity was established by documenting that in ALS patients, change in ALSFRS-R scores correlated with change in strength over time, was closely associated with quality of life measures, and predicted survival.|Week 0, Week 2, Week 6, Week 12 (or Early Termination Date), and Week 16|||scores on a scale||95% Confidence Interval|Mean
660908|NCT01849770|Secondary|Mean Weekly Cramp Frequency||Week 3-12, post titration of study medication|||cramps/week||95% Confidence Interval|Mean
660909|NCT01849770|Secondary|Mean Cerebrospinal Fluid (CSF)/Plasma Ratio|The concentrations of Mexiletine were measured in cerebrospinal fluid (CSF) and plasma.|Week 6 Visit (up to 6 hours post dose)|||ratio||Standard Deviation|Mean
660910|NCT01849770|Secondary|Area Under the Concentration Time Curve (AUC) of Mexiletine in Plasma.|Subjects will have blood drawn to assess mexiletine concentrations for pharmacokinetics (PK) at the Week 6 Visit.|Week 6 Visit (up to 6 hours post dose)|||µg*hr/mL||Standard Deviation|Mean
660911|NCT01849770|Secondary|Peak Plasma Concentration (Cmax) of Mexiletine|Subjects will have blood drawn to assess mexiletine concentrations for pharmacokinetics (PK) at the Week 6 Visit.|Week 6 Visit (pre-dose, hours 1, 2, 3, and 6 post-dose on Week 6)|||pg/mL||Standard Deviation|Mean
660912|NCT01849770|Secondary|Trough Plasma Concentration (Cmin) of Mexiletine|Subjects will have blood drawn to assess mexiletine concentrations for pharmacokinetics (PK) at the Week 6 Visit.|Week 6 Visit (pre-dose, hours 1, 2, 3, and 6 post-dose on Week 6)|||pg/mL||Standard Deviation|Mean
660913|NCT01849770|Primary|Percentage of Participants That Discontinued Study Drug|Information on adverse effects of mexiletine will be determined at each visit by direct questioning of the subjects, clinical examination, review of concomitant medications, vital signs and laboratory test results.|Screening, Baseline Visit Pre-Dose and Post-Dose, Weeks 2, 6, and 12, and at the Final Safety Visit, if a subject discontinues study drug early. Adverse Events will be assessed via telephone Weeks 1, 10, and 16.|||percentage of participants|||Number
660914|NCT01849692|Secondary|Change From Baseline in CSFT, Cohort 4|CSFT was assessed by SD-OCT and measured in microns. A decrease in CSFT indicates improvement. One eye (study eye) contributed to the analysis.|Baseline, Day 7, Day 14, Day 28, Day 42, Day 56|This analysis population includes all subjects who were randomized, received the initial injection or infusion, and had a baseline value and at least 1 postbaseline measurement for the period up to Day 28 for the primary efficacy variables, with LOCF imputation for missing values.||microns||Standard Deviation|Mean
660915|NCT01849692|Secondary|Change From Baseline in CSFT, Cohort 3|CSFT was assessed by SD-OCT and measured in microns. A decrease in CSFT indicates improvement. One eye (study eye) contributed to the analysis.|Baseline, Day 7, Day 14, Day 28, Day 42, Day 56|This analysis population includes all subjects who were randomized, received the initial injection or infusion, and had a baseline value and at least 1 postbaseline measurement for the period up to Day 28 for the primary efficacy variables, with LOCF imputation for missing values.||microns||Standard Deviation|Mean
660916|NCT01849692|Secondary|Change From Baseline in CSFT, Cohort 2|CSFT was assessed by SD-OCT and measured in microns. A decrease in CSFT indicates improvement. One eye (study eye) contributed to the analysis.|Baseline, Day 7, Day 14, Day 28, Day 42, Day 56|This analysis population includes all subjects who were randomized, received the initial injection or infusion, and had a baseline value and at least 1 postbaseline measurement for the period up to Day 28 for the primary efficacy variables, with LOCF imputation for missing values.||microns||Standard Deviation|Mean
660917|NCT01849692|Secondary|Change From Baseline in CSFT, Cohort 1|CSFT was assessed by Spectral-Domain Optical Coherence Tomography (SD-OCT) and measured in microns. A decrease in CSFT indicates improvement. One eye (study eye) contributed to the analysis.|Baseline, Day 7, Day 14, Day 28, Day 42, Day 56|This analysis population includes all subjects who were randomized, received the initial injection or infusion, and had a baseline value and at least 1 postbaseline measurement for the period up to Day 28 for the primary efficacy variables, with LOCF imputation for missing values.||microns||Standard Deviation|Mean
660931|NCT01849458|Secondary|Number of Study Participants With Re-tears|Assess re-tears of the repaired tendon using ultrasound imaging. The definition of a re-tear for the rate reported is any full thickness tear in a tendon that was repaired with the BioFiber Scaffold that is at least 80% of the size of the original tear.|12 Months|||Participants|||Count of Participants
660918|NCT01849692|Secondary|Change From Baseline in BCVA, Cohort 4|BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly out of 70 letters on the chart. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.|Baseline, Day 7, Day 14, Day 28, Day 42, Day 56|This analysis population includes all subjects who were randomized, received the initial injection or infusion, and had a baseline value and at least 1 postbaseline measurement for the period up to Day 28 for the primary efficacy variables, with LOCF imputation for missing values.||letters||Standard Deviation|Mean
660919|NCT01849692|Secondary|Change From Baseline in BCVA, Cohort 3|BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly out of 70 letters on the chart. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.|Baseline, Day 7, Day 14, Day 28, Day 42, Day 56|This analysis population includes all subjects who were randomized, received the initial injection or infusion, and had a baseline value and at least 1 postbaseline measurement for the period up to Day 28 for the primary efficacy variables, with LOCF imputation for missing values.||letters||Standard Deviation|Mean
660920|NCT01849692|Secondary|Change From Baseline in BCVA, Cohort 2|BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly out of 70 letters on the chart. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.|Baseline, Day 7, Day 14, Day 28, Day 42, Day 56|This analysis population includes all subjects who were randomized, received the initial injection or infusion, and had a baseline value and at least 1 postbaseline measurement for the period up to Day 28 for the primary efficacy variables, with LOCF imputation for missing values.||letters||Standard Deviation|Mean
660921|NCT01849692|Secondary|Change From Baseline in BCVA, Cohort 1|BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly out of 70 letters on the chart. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.|Baseline, Day 7, Day 14, Day 28, Day 42, Day 56|This analysis population includes all subjects who were randomized, received the initial injection or infusion, and had a baseline value and at least 1 postbaseline measurement for the period up to Day 28 for the primary efficacy variables, with last observation carried forward (LOCF) imputation for missing values.||letters||Standard Deviation|Mean
660922|NCT01849692|Primary|Percentage of Responders Based on CSFT and BCVA Outcomes at Day 14 and Day 28|"A subject was considered a responder if at least 3 out of the following 4 criteria were fulfilled in comparison to baseline:
Greater than or equal to 4 letter gain in BCVA at Day 14
Greater than or equal to 4 letter gain in BCVA at Day 28
Greater than or equal to 80 micron decrease in CSFT at Day 14
Greater than or equal to 80 micron decrease in CSFT at Day 28. BCVA was measured by the number of letters read out of a possible 70 letters on the ETDRS chart. One eye (study eye) contributed to the analysis."|Baseline, Day 14, Day 28|"This analysis population includes all subjects who were randomized, received the initial injection or infusion, and had a baseline value and at least 1 postbaseline measurement for the period up to Day 28 for the primary efficacy variables (BCVA and/or CSFT). Here, n is the number of subjects in each arm group."||percentage of responders||90% Confidence Interval|Number
660923|NCT01849588|Other Pre-specified|Decrease Alpha-fetoprotein(AFP) Level > 20% From the Baseline|The proportion of participants with a decrease of greater than 20% in AFP (alpha-fetoprotein) level between baseline and any subsequent measurement following treatment with sorafenib will be reported.|2 years|AFP levels were not available for one participant.||Participants|||Count of Participants
660924|NCT01849588|Secondary|Overall Survival|Overall survival is defined as the time period between enrollment and the date of death. Participants who are still alive at last contact will be censored at this date.|2 years|||months||Full Range|Mean
660925|NCT01849588|Secondary|Time to Radiological Tumor Progression|Time to radiological tumor progression is defined as the time period between enrollment and the earlier of tumor progression and death. Participants who are alive and progression-free at the date of last contact will be censored at this date.|2 years|Study was terminated early due to slow accrual.||months||Full Range|Mean
660926|NCT01849588|Primary|Decline in HCV-RNA Level|Successful decline in HCV (hepatitis C virus)-RNA level, with success defined as a decrease of at least two logs of HCV-RNA between baseline and any subsequent measurement.|up to 2 years|||Participants|||Count of Participants
660927|NCT01849562|Primary|Safety and Tolerability of 12 Weeks of Sovaprevir and 3102 in Combination With Ribavirin in Subjects With Chronic Hepatitis C Genotype 1 Viral Infection.|To determine safety and tolerability of 12 weeks of sovaprevir/ACH-0143102/RBV in subjects with chronic hepatitis C genotype 1, the following criteria will be used: the number of subjects with discontinuations due to AEs, treatment emergent G3/G4 AEs, treatment emergent G3/G4 laboratory abnormalities, clinically significant ECGs.|12 weeks|The analysis population for safety and tolerability was the safety population, defined as all randomized subjects who received at least one dose of study drug. For this study, the safety population and the FA set were the same.||participants|||Number
660928|NCT01849562|Primary|Incidence of Sustained Virologic Response 4 Weeks (SVR4) After the Completion of Treatment.|Incidence of SVR4 after the completion of dosing, reported as HCV RNA less than the lower limit of quantification (<LLOQ), in subjects who received active treatment (sovaprevir and ACH-0143102 in combination with ribavirin) as compared to those who received placebo.|Four weeks after the completion of treatment|The analysis population for SVR4 was the full analysis (FA) set, defined as all randomized subjects who received at least one dose of study drug and had at least one baseline/post HCV RNA assessment. For this study, the FA set and the safety population were the same.||Percentage of Subjects with SVR4|||Number
660929|NCT01849497|Secondary|Percent Change From Baseline in LDL-C at Week 6||Baseline and Week 6|Full analysis set||percent change||Standard Error|Least Squares Mean
660930|NCT01849497|Primary|Percentage of Participants With Full Administration of Evolocumab at Both Weeks 2 and 4|Self-administration of evolocumab was assessed by a telephone interview at Weeks 2 and 4. Each participant was asked about all attempted injection(s) and if the injection was administered in part, full, or none at all.|Week 2 and Week 4|Full analysis set||percentage of participants||95% Confidence Interval|Number
664953|NCT01778530|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For details, see the adverse event module.|5 months, 28 days|||participants|||Number
660932|NCT01849458|Secondary|Number of Study Participants With Re-tears|Assess re-tears of the repaired tendon using ultrasound imaging. The definition of a re-tear for the rate reported is any full thickness tear in a tendon that was repaired with the BioFiber Scaffold that is at least 80% of the size of the original tear.|6 Months|||Participants|||Count of Participants
660933|NCT01849458|Secondary|Clinical Functional Outcome - WORC Index|Evaluate clinical functional outcome WORC Index. This is a quality-of-life measurement specific for rotator cuff disease based on 21 questions answered using visual analog scales. It is organized in 5 subscales: physical symptoms, sprots/recreation, work, lifestyle, and emotions. Each item has a possible score from 0-100 where higher scores represent a lower quality of life. The scores are summed up to a possible 2100 points. The total number of points is subtracted from 2100, divided by 2100, then multiplied by 100 to create a percentage. The final score is thus a percentage ranging from 0 to 100 with higher percentages indicating better quality of life.|12 Months|||Percentage of WORC Index||Standard Deviation|Mean
660934|NCT01849458|Secondary|Clinical Functional Outcome - WORC Index|Evaluate clinical functional outcome WORC Index. This is a quality-of-life measurement specific for rotator cuff disease based on 21 questions answered using visual analog scales. It is organized in 5 subscales: physical symptoms, sprots/recreation, work, lifestyle, and emotions. Each item has a possible score from 0-100 where higher scores represent a lower quality of life. The scores are summed up to a possible 2100 points. The total number of points is subtracted from 2100, divided by 2100, then multiplied by 100 to create a percentage. The final score is thus a percentage ranging from 0 to 100 with higher percentages indicating better quality of life.|6 Months|One subject is missing data for this outcome measure thus a total of 49 subjects were analyzed in this section.||Percentage of WORC Index||Standard Deviation|Mean
660935|NCT01849458|Secondary|Clinical Functional Outcome - Adjusted Constant-Murley Score|Evaluate clinical functional outcome Adjusted Constant-Murley Score. The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient.[1] The Constant-Murley score was introduced to determine the functionality after the treatment of a shoulder injury. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function. A score of 0 is considered the worst outcome and 100 is considered the best outcome.|12 Month|||scores on a scale||Standard Deviation|Mean
660936|NCT01849458|Secondary|Clinical Functional Outcome - Adjusted Constant-Murley Score|Evaluate clinical functional outcome Adjusted Constant-Murley Score. The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient.[1] The Constant-Murley score was introduced to determine the functionality after the treatment of a shoulder injury. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function. A score of 0 is considered the worst outcome and 100 is considered the best outcome.|6 Months|50 Participants||scores on a scale||Standard Deviation|Mean
660937|NCT01849458|Primary|Number of Participants With Device Associated Adverse Events|"The primary objective is to report the number of participants with device associated adverse events.
Device associated adverse events are defined as adverse events that are classified as possibly or definitely related to the study product or procedure, or anticipated adverse events listed in the product's Instruction for Use regardless of relationship to the study device."|12 Months|||Participants|||Count of Participants
660938|NCT01849419|Secondary|Motivation to Socialize (Placebo)|"Participants complete the social choice task following administration of MDMA or placebo during which they choose between spending time 1) talking with another person; 2) sitting quietly alone; or 3) solving word problems. Choices were rated on a scale of 1 to 10 (with 10 indicating the highest level of desire to engage in that activity). The main outcome measure was desire to socialize (i.e., rating of talking to another person)."|5 minutes during each session|||units on a scale||Standard Error|Mean
660939|NCT01849419|Secondary|Motivation to Socialize (Oxytocin)|"Participants complete the social choice task following administration of MDMA or placebo during which they choose between spending time 1) talking with another person; 2) sitting quietly alone; or 3) solving word problems. Choices were rated on a scale of 1 to 10 (with 10 indicating the highest level of desire to engage in that activity). The main outcome measure was desire to socialize (i.e., rating of talking to another person)."|5 minutes during each session|||units on a scale||Standard Error|Mean
660940|NCT01849419|Secondary|Motivation to Socialize (MDMA)|"Participants complete the social choice task following administration of MDMA or placebo during which they choose between spending time 1) talking with another person; 2) sitting quietly alone; or 3) solving word problems. Choices were rated on a scale of 1 to 10 (with 10 indicating the highest level of desire to engage in that activity). The main outcome measure was desire to socialize (i.e., rating of talking to another person)."|5 minutes during each session|||units on a scale||Standard Error|Mean
660941|NCT01849419|Secondary|Cardiovascular Response to Placebo (Diastolic Blood Pressure)|Diastolic Blood Pressure (mmHg) was assessed before drug administration and repeatedly after drug administration for the each session. Results are presented as the mean response over the entire session calculated as change from baseline.|repeatedly during each session|||mmHg||Standard Error|Mean
660942|NCT01849419|Secondary|Cardiovascular Response to Oxytocin (Diastolic Blood Pressure)|Diastolic Blood Pressure (mmHg) was assessed before drug administration and repeatedly after drug administration for the each session. Results are presented as the mean response over the entire session calculated as change from baseline.|repeatedly during each session|||mmHg||Standard Error|Mean
660943|NCT01849419|Secondary|Cardiovascular Response to MDMA (Diastolic Blood Pressure)|Diastolic Blood Pressure (mmHg) was assessed before drug administration and repeatedly after drug administration for the each session. Results are presented as the mean response over the entire session calculated as change from baseline.|repeatedly during each session|||mmHg||Standard Error|Mean
660944|NCT01849419|Secondary|Cardiovascular Response to Placebo (Systolic Blood Pressure)|Systolic Blood Pressure (mmHg) was assessed before drug administration and repeatedly after drug administration for the each session. Results are presented as the mean response over the entire session calculated as change from baseline.|repeatedly during each session|||mmHg||Standard Error|Mean
660945|NCT01849419|Secondary|Cardiovascular Response to Oxytocin (Systolic Blood Pressure)|Systolic Blood Pressure (mmHg) was assessed before drug administration and repeatedly after drug administration for the each session. Results are presented as the mean response over the entire session calculated as change from baseline.|repeatedly during each session|||mmHg||Standard Error|Mean
660946|NCT01849419|Secondary|Cardiovascular Response to MDMA (Systolic Blood Pressure)|Systolic Blood Pressure (mmHg) was assessed before drug administration and repeatedly after drug administration for the each session. Results are presented as the mean response over the entire session calculated as change from baseline.|repeatedly during each session|||mmHg||Standard Error|Mean
660947|NCT01849419|Secondary|Cardiovascular Response to Placebo (Heart Rate)|Heart rate (bpm) was assessed before drug administration and repeatedly after drug administration for the each session. Results are presented as the mean response over the entire session calculated as change from baseline.|repeatedly during each session|||bpm||Standard Error|Mean
660948|NCT01849419|Secondary|Cardiovascular Response to Oxytocin (Heart Rate)|Heart rate (bpm) was assessed before drug administration and repeatedly after drug administration for the each session. Results are presented as the mean response over the entire session calculated as change from baseline.|repeatedly during each session|||bpm||Standard Error|Mean
660949|NCT01849419|Secondary|Cardiovascular Response to MDMA (Heart Rate)|Heart rate (bpm) was assessed before drug administration and repeatedly after drug administration for the each session. Results are presented as the mean response over the entire session calculated as change from baseline.|repeatedly during each session|||bpm||Standard Error|Mean
660950|NCT01849419|Secondary|Subjective Response to Placebo (Ratings of 'Feel Sociable')|"Participants completed this visual analog questionnaire item during which participants selected a rating between 0 (Not at all) to 100 (Extremely). Participants completed this questionnaire item before drug administration and every 30 minutes after drug administration at each session for a total of 6 times. Results are presented as the mean response over the entire session calculated as change from baseline."|repeatedly during each session|||units on a scale||Standard Error|Mean
660951|NCT01849419|Secondary|Subjective Response to Oxytocin (Ratings of 'Feel Sociable')|"Participants completed this visual analog questionnaire item during which participants selected a rating between 0 (Not at all) to 100 (Extremely). Participants completed this questionnaire item before drug administration and every 30 minutes after drug administration at each session for a total of 6 times. Results are presented as the mean response over the entire session calculated as change from baseline."|repeatedly during each session|||units on a scale||Standard Error|Mean
660952|NCT01849419|Secondary|Subjective Response to MDMA (Ratings of 'Feel Sociable')|"Participants completed this visual analog questionnaire item during which participants selected a rating between 0 (Not at all) to 100 (Extremely). Participants completed this questionnaire item before drug administration and every 30 minutes after drug administration at each session for a total of 6 times. Results are presented as the mean response over the entire session calculated as change from baseline."|repeatedly during each session|||units on a scale||Standard Error|Mean
660953|NCT01849419|Secondary|Subjective Response to Placebo (Ratings of 'Feel High')|"Participants completed this visual analog questionnaire item during which participants selected a rating between 0 (Not at all) to 100 (Extremely). Participants completed this questionnaire item before drug administration and every 30 minutes after drug administration at each session for a total of 6 times. Results are presented as the mean response over the entire session calculated as change from baseline."|repeatedly during each session|||units on a scale||Standard Error|Mean
660954|NCT01849419|Secondary|Subjective Response to Oxytocin (Ratings of 'Feel High')|"Participants completed this visual analog questionnaire item during which participants selected a rating between 0 (Not at all) to 100 (Extremely). Participants completed this questionnaire item before drug administration and every 30 minutes after drug administration at each session for a total of 6 times. Results are presented as the mean response over the entire session calculated as change from baseline."|repeatedly during each session|||units on a scale||Standard Error|Mean
660955|NCT01849419|Secondary|Subjective Response to MDMA (Ratings of 'Feel High')|"Participants completed this visual analog questionnaire item during which participants selected a rating between 0 (Not at all) to 100 (Extremely). Participants completed this questionnaire item before drug administration and every 30 minutes after drug administration at each session for a total of 6 times. Results are presented as the mean response over the entire session calculated as change from baseline."|repeatedly during each session|||units on a scale||Standard Error|Mean
660956|NCT01849419|Secondary|Subjective Response to Placebo (Ratings of 'Feel Drug')|"Participants completed this visual analog questionnaire item during which participants selected a rating between 0 (Not at all) to 100 (Extremely). Participants completed this questionnaire item before drug administration and every 30 minutes after drug administration at each session for a total of 6 times. Results are presented as the mean response over the entire session calculated as change from baseline."|repeatedly during each session|||units on a scale||Standard Error|Mean
660957|NCT01849419|Secondary|Subjective Response to Oxytocin (Ratings of 'Feel Drug')|"Participants completed this visual analog questionnaire item during which participants selected a rating between 0 (Not at all) to 100 (Extremely). Participants completed this questionnaire item before drug administration and every 30 minutes after drug administration at each session for a total of 6 times. Results are presented as the mean response over the entire session calculated as change from baseline."|repeatedly during each session|||units on a scale||Standard Error|Mean
660958|NCT01849419|Secondary|Subjective Response to MDMA (Ratings of 'Feel Drug')|"Participants completed this visual analog questionnaire item during which participants selected a rating between 0 (Not at all) to 100 (Extremely). Participants completed this questionnaire item before drug administration and every 30 minutes after drug administration at each session for a total of 6 times. Results are presented as the mean response over the entire session calculated as change from baseline."|repeatedly during each session|||units on a scale||Standard Error|Mean
660970|NCT01849068|Secondary|Change in Intestinal mRNA Expression Levels of SREBP-2, NPC1L1, ABCG5/8, PCSK9 and HMG CoA Reductase Between the Two 12-week Interventions|"We combined the results at the end of each ezetimibe phase from both sequence (average and standard deviation).
We combined the results at the end of each placebo phase from both sequence (average and standard deviation)."|At the end of the two 12-week interventions (Week 12 and 24)|||#copies/100000 copies housekeeping gene||Standard Deviation|Mean
660959|NCT01849419|Primary|Emotional Recognition (Placebo)|"Participants completed the Dynamic Emotional Identification Task, or DEIT (Wardle et al. 2012) following MDMA, oxytocin or placebo administration during which they identify emotional facial expressions presented on the screen. Participants completed this task once during each of the sessions.
In the DEIT, 10 actors performed angry, fearful, sad, and happy expressions, for a total of 40 sequences, which were presented in random order. Each sequence consisted of 50 “frames” progressing from 0 to 100% emotional intensity at 2% steps, producing a color video of an emotional expression developing. Participants were instructed to “press the space bar as soon as you know what expression is being displayed.” This ended the sequence and presented options of “angry,” “fearful,” “sad,” and “happy.”
Perception of expressions was quantified as the intensity (0–100 %) of the face when the participant pressed the space bar for correctly identified sequences."|15 minutes during each session|||percent intensity||Standard Error|Mean
660960|NCT01849419|Primary|Emotional Recognition (Oxytocin)|"Participants completed the Dynamic Emotional Identification Task, or DEIT (Wardle et al. 2012) following MDMA, oxytocin or placebo administration during which they identify emotional facial expressions presented on the screen. Participants completed this task once during each of the sessions.
In the DEIT, 10 actors performed angry, fearful, sad, and happy expressions, for a total of 40 sequences, which were presented in random order. Each sequence consisted of 50 “frames” progressing from 0 to 100% emotional intensity at 2% steps, producing a color video of an emotional expression developing. Participants were instructed to “press the space bar as soon as you know what expression is being displayed.” This ended the sequence and presented options of “angry,” “fearful,” “sad,” and “happy.”
Perception of expressions was quantified as the intensity (0–100 %) of the face when the participant pressed the space bar for correctly identified sequences."|15 minutes during each session|||percent intensity||Standard Error|Mean
660961|NCT01849419|Primary|Emotional Recognition (MDMA)|"Participants complete the Dynamic Emotional Identification Task, or DEIT (Wardle et al. 2012) following MDMA, oxytocin or placebo administration during which they identify emotional facial expressions presented on the screen. Participants completed this task once during each of the sessions.
In the DEIT, 10 actors performed angry, fearful, sad, and happy expressions, for a total of 40 sequences, which were presented in random order. Each sequence consisted of 50 “frames” progressing from 0 to 100% emotional intensity at 2% steps, producing a color video of an emotional expression developing. Participants were instructed to “press the space bar as soon as you know what expression is being displayed.” This ended the sequence and presented options of “angry,” “fearful,” “sad,” and “happy.”
Perception of expressions was quantified as the intensity (0–100 %) of the face when the participant pressed the space bar for correctly identified sequences."|15 minutes during each session|||percent intensity||Standard Error|Mean
660962|NCT01849289|Secondary|Number of Treatment Emergent AEs (Adverse Events)|Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)|On or after the first day of exposure to randomised trial drug (week 0) and no later than seven days after last exposure to randomised trial drug (week 27)|The SAS included all subjects receiving at least one dose of investigational product.||number of events|||Number
660963|NCT01849289|Secondary|Responder for HbA1c (Below 7.0%) at End of Trial Without Severe and Minor Hypoglycaemic Episodes|A responder for HbA1c without severe or confirmed hypoglycaemia is defined as a subject, who meets the HbA1c target at end of trial without treatment emergent severe or confirmed hypoglycaemia during the last 12 weeks of treatment or within 7 days from last treatment.|Week 26|The FAS included all randomised subjects.||participants|||Number
660964|NCT01849289|Secondary|Within-subject Variability as Measured by Coefficient of Variation (CV%) in Pre-breakfast SMPG (Self-measured Plasma Glucose)|Within subject Coefficient of variation(CV[%]) in pre-breakfast self measured plasma glucose for dose adjustment after 26 treatment weeks are displayed below.|Week 26|The FAS included all randomised subjects. Missing data were imputed using LOCF. For 2 subjects in the IDeg OD arm it was not possible to estimate CV(%) due to missing data.||percentage||Standard Deviation|Mean
660965|NCT01849289|Secondary|Change From Baseline in FPG (Fasting Plasma Glucose) (Analysed by Central Laboratory)|Change from baseline in FPG after 26 weeks of treatment.|Week 0, week 26|The FAS included all randomised subjects. LOCF values are presented for this endpoint. 7 subjects were not included in the analysis.||mmol/L||Standard Deviation|Mean
660966|NCT01849289|Secondary|Number of Severe and Minor Treatment Emergent Hypoglycaemic Episodes|Confirmed hypoglycaemic episodes consisted of episodes of severe hypoglycaemia as well as minor hypoglycaemic episodes with a confirmed PG value of less than 3.1 mmol/L (56 mg/dL).Minor hypoglycaemic episode is defined as an episode with symptoms consistent with hypoglycaemia with confirmation by full blood glucose < 2.8 mmol/L (50 mg/dL), or PG < 3.1 mmol/L (56 mg/dL) and which is handled by the subject himself/herself or any asymptomatic full blood glucose value < 2.8 mmol/L (50 mg/dL) or PG value < 3.1 mmol/L (56 mg/dL).|On or after the first day of exposure to randomised trial drug (week 0) and no later than 7 days after last exposure to randomised trial drug (week 27)|The Safety analysis set (SAS) included all subjects receiving at least one dose of the investigational product or its comparator.||Episodes/100 years of patient exposure|||Number
660967|NCT01849289|Primary|Change From Baseline in HbA1c (%) (Analysed by Central Laboratory)|Change from baseline in HbA1c (%) after 26 weeks of treatment.|Week 0, week 26|The FAS included all randomised subjects. Last Observation Carried Forward (LOCF) values were presented for this endpoint.||percentage of glycosylated haemoglobin||Standard Deviation|Mean
660968|NCT01849068|Secondary|Change in Protein Levels of SREBP-2, NPC1L1, ABCG5/8, PCSK9 and HMG CoA Reductase Between the Two 12-week Interventions|"We combined the results at the end of each ezetimibe phase from both sequence (average and standard deviation).
We combined the results at the end of each placebo phase from both sequence (average and standard deviation)."|At the end of the two 12-week interventions (Week 12 and 24)|Data will never be analyzed because the mRNA expression of SREBP-2, NPC1L1, ABCG5/8, PCSK9 and HMG CoA reductase are sufficient.|||||
660969|NCT01849068|Secondary|Change in Intestinal Protein Levels of LDL Receptor Between the Two 12-week Interventions|"We combined the results at the end of each ezetimibe phase from both sequence (average and standard deviation).
We combined the results at the end of each placebo phase from both sequence (average and standard deviation)."|At the end of the two 12-week interventions (Week 12 and 24)|Data will never be analyzed because the mRNA expression of LDL receptor is sufficient.|||||
660971|NCT01849068|Primary|Change in Intestinal mRNA Expression Levels of LDL Receptor Between the Two 12-week Interventions|"We combined the results at the end of each ezetimibe phase from both sequence (average and standard deviation).
We combined the results at the end of each placebo phase from both sequence (average and standard deviation)."|At the end of the two 12-week interventions (Week 12 and 24)|||#copies/100000 copies housekeeping gene||Standard Deviation|Mean
660972|NCT01848990|Secondary|Standard Deviation of Self-Monitoring Blood Glucose Values at 6 Months|Standard deviation of self-monitoring blood glucose values was calculated based on measurements taken within 15 minutes before a meal, 1 month and up to 6 months after study drug administration. LS means were calculated from ANOVA with treatment (Hylenex, standard rapid-acting insulin CSII) as a fixed effect.|After Month 1 up to Month 6|Participants who received at least one dose of study drug and had evaluable self-monitoring blood glucose data.||mg/dL||Standard Error|Least Squares Mean
660973|NCT01848990|Secondary|Mean Glucose Excursions at 6 Months|A 4-hour postprandial glucose excursion was measured for 3 meals after 1 month up to 6 months. For each of the 3 meals, the mealtime (breakfast, lunch, and dinner) excursions were calculated as the post-meal glucose value minus the pre-meal (for measurements taken within 15 minutes before a meal). The average of all excursions is presented. Least Squares (LS) means were calculated from ANOVA with treatment (Hylenex, standard rapid-acting insulin CSII) as a fixed effect.|After Month 1 up to Month 6|Participants who received at least one dose of study drug and had evaluable mean glucose excursion data.||milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
660974|NCT01848990|Secondary|Rates of Hyperglycemia Events|Overall rates of hyperglycemia (defined as blood glucose >240 mg/dL and >300 mg/dL) were based on measurements after 1 month up to 6 months. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|After Month 1 up to Month 6|Participants who received at least one dose of study drug and whose average bolus insulin dose was within 15 minutes before a meal.||events per participant per month|||Number
660975|NCT01848990|Secondary|Rates of Hypoglycemia Events (HE)|Overall rates of hypoglycemia (defined as blood glucose ≤70 milligrams per deciliter [mg/dL] and <56 mg/dL) were based on measurements after 1 month up to 6 months. A severe HE was classified as an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. A nocturnal HE was classified as an event with a blood glucose of ≤70 mg/dL with start time between 2300 and 0600, inclusive. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|After Month 1 up to Month 6|Participants who received at least one dose of study drug and whose average bolus insulin dose was within 15 minutes before a meal.||events per participant per month|||Number
660976|NCT01848990|Primary|Change From Baseline to 6 Months in Glycosylated Hemoglobin (HbA1c)||Baseline, 6 Months|Participants who received at least one dose of study drug and had evaluable HbA1c data.||percentage of HbA1c||Standard Deviation|Mean
660977|NCT01848977|Primary|Sum of Tissue Oxygenation Value Which Above Basline Value After Reperfusion Period Until Basline Value Was Achieved|During vascular occlusion test, the changes of StO2 and SrO2 values can divided into 3 epoch; Desaturation, Reoxygenation and Reactive hyperemia. After data collection, the rate of desaturation and reoxygenation were calculated.|Until basline tissue oxygenation value was achieved|||%*min||Standard Deviation|Mean
660978|NCT01848977|Secondary|Baseline, Miminum and Maximum Tissue Oxygenation Value Measured by INVOS® (SrO2) Until Basline Value Was Achieved|Before VOT. basline StO2 and SrO2 were recorded and compared each other. During VOT, minimum/maximum StO2 and SrO2 were also recorded and compared each other.|Until basline tissue oxygenation value was achieved|||percentage of oxyhemoglobin||Standard Deviation|Mean
660979|NCT01848977|Primary|Change of Tissue Oxygenation Value During Ischemia and Reperfusion Period Until Basline Value Was Achieved|During vascular occlusion test, the changes of StO2 and SrO2 values can divided into 3 epoch; Desaturation, Reoxygenation and Reactive hyperemia. After data collection, the rate of desaturation and reoxygenation were calculated.|Until basline tissue oxygenation value was achieved|||%/min||Standard Deviation|Mean
660980|NCT01848938|Secondary|Patient`s Global Impression of Improvement Scale (PGI-I)|A self-rated question that asks about the change experienced after treatment with 7 response options, ranging from “very much better” to “very much worse”.|three months|intention-to-treat analysis. Missing values at follow-up were replaced with a neutral value (i.e., no change).||participants|||Number
660981|NCT01848938|Secondary|Incontinence Episode Frequency (IEF)|number of incontinence episodes per week|baseline, three months|intention-to-treat analysis. Missing values at follow-up were replaced with the corresponding values at baseline (i.e., no change).||episodes per week||Inter-Quartile Range|Median
660982|NCT01848938|Secondary|Patient Satisfaction|A self-rated question about if the current treatment was sufficient, with three response options|three months|Data for this outcome measure could only be collected for the smartphone treatment group.||participants|||Number
660983|NCT01848938|Secondary|Usage of Incontinence Aids|Usage of incontinence aids during the last 4 weeks.|three months|intention-to-treat analysis. Missing values at follow-up were replaced with the corresponding values at baseline (i.e., no change).||participants|||Number
660984|NCT01848938|Primary|International Consultation on Incontinence Modular Questionnaire Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol)|The instrument includes 19 items on the impact of the leakage. All items are scored 1-4 (not at all/never, slightly/sometimes, moderately/often, a lot/all the time). The overall score is 19-76, with higher values indicating increased impact on QOL.|baseline, three months|intention-to-treat analysis||units on a scale||Standard Deviation|Mean
660985|NCT01848938|Primary|International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF)|Three items on frequency, amount of leakage and overall impact. Scoring 0-21, higher values indicating increasing severity|baseline, three months|intention-to-treat analysis||units on a scale||Standard Deviation|Mean
660986|NCT01848899|Primary|Thrombin Generation Test: After Coronary Angiography|The thrombin generation test uses recombinant tissue factor as a stimulus to initiate thrombin generation in plasma samples. The outcome from this assay is reported as area under the curve and represents the amount of thrombin in each sample. The curve is created by measuring the generated thrombin every 20 seconds from 0 to 95 minutes post stimulus.|1 hour|A valid thrombogram was generated post-diagnostic angiography in 43/50 participants in the Ioxaglate arm and 37/50 participants in the Iodixanol arm. Thus, not all 100 participants were able to be included in analysis.||nM*minutes||Inter-Quartile Range|Median
660987|NCT01848899|Secondary|Percent Change in Maximal Platelet Aggregation: ADP|Percent change in maximal platelet aggregation from pre- to post-contrast in response to 20 μM of ADP|1 hour|Sufficient volumes of blood were not available for all participants to perform the analyses required for some secondary outcomes. Thus, not all 100 participants are included in this outcome measure.||Percent change||Inter-Quartile Range|Median
660988|NCT01848899|Secondary|Percent Change in Maximal Platelet Aggregation: Arachidonic Acid|Percent change in maximal platelet aggregation from pre- to post-contrast in response to 1600 μM arachidonic acid|1 hour|Sufficient volumes of blood were not available for all participants to perform the analyses required for some secondary outcomes. Thus, not all 100 participants are included in this outcome measure.||Percent change||Inter-Quartile Range|Median
660989|NCT01848899|Secondary|Percent Change in Maximal Platelet Aggregation: Epinephrine|Percent change in maximal platelet aggregation from pre- to post-contrast in response to 10 μM epinephrine|Baseline to 1 hour|Sufficient volumes of blood were not available for all participants to perform the analyses required for some secondary outcomes. Thus, not all 100 participants are included in this outcome measure.||Percent change||Inter-Quartile Range|Median
660990|NCT01848899|Primary|Thrombin Generation Test: Baseline|The thrombin generation test uses recombinant tissue factor as a stimulus to initiate thrombin generation in plasma samples. The outcome from this assay is reported as area under the curve and represents the amount of thrombin in each sample. The curve is created by measuring the generated thrombin every 20 seconds from 0 to 95 minutes post stimulus.|baseline|A valid thrombogram was generated post-diagnostic angiography in 43/50 participants in the Ioxaglate arm and 37/50 participants in the Iodixanol arm. Thus, not all 100 participants were able to be included in analysis.||nM*minutes||Inter-Quartile Range|Median
660991|NCT01848847|Primary|Pain Scoring(VAS)|Pain scoring was made by 10 cm visual analog scale. pain score (recorded by the patient on a 10 –point visual analog scale (VAS) which means pain increases with increasing number|2 months|||units on a scale||Standard Deviation|Mean
660992|NCT01848847|Secondary|Procedure Duration|Procedural time which will be measured in minutes|two months||||||
660993|NCT01848847|Secondary|Patient Acceptability and Pain Scoring|Patient acceptability and pain scoring will be evaluated by Likert scale and visual analog scale.|two months||||||
660994|NCT01848847|Primary|Ease of Cervical Entry|Ease of cervical entry which will be assessed by Likert scale.The outcome measures in this study were the ease of cervical entry (judged by the individual surgeons using a 5-point Likert scale: very difficult= 1, difficult= 2, fair = 3, easy= 4, and very easy = 5.|2 months|||units on a scale||Standard Deviation|Mean
660995|NCT01848834|Other Pre-specified|Number of Participants With Log Fold Change From Baseline in Cytokines (Interleukin 10 [IL-10]) >1|IL-10 is an anti-inflammatory cytokine. The number of participants with a log fold change from Baseline in IL-10 >1 was to be presented. Protocol Amendment 03 (26 May 2015) removed the secondary objective of investigating the relationship between programmed cell death 1 (PD-1) inhibition and up-regulation of cytokines biomarkers predicting response (e.g. IL-10) from the protocol. No data were collected for this outcome measure.|Baseline and Week 8|The population was to consist of all randomized participants who: 1) received ≥1 dose of study treatment and 2) had a baseline IL-10 assessment, and 3) had a post baseline IL-10 assessment. No data were collected for this outcome measure.|||||
660996|NCT01848834|Secondary|Overall RECIST 1.1 Response Rate Based on Investigator Assessment for Cohort B2|ORR was defined as the percentage of participants in the analysis population who experienced a CR (disappearance of all target lesions) or a PR (at least a 30% decrease in the sum of diameters of target lesions) and was assessed by Investigator evaluation. The percentages of participants who experienced a CR or PR in Cohorts A, B, C and D based on Investigator assessment are presented. ORR per Investigator assessment is presented for the other cohorts in a separate outcome measure.|Every 8 weeks until disease progression (Up to approximately 14 months)|The population consisted of all Cohort B2 participants who received ≥1 dose of study treatment.||Percentage of Participants||95% Confidence Interval|Number
660997|NCT01848834|Secondary|Overall RECIST 1.1 Response Rate Based on Investigator Assessment for Cohorts A, B, C and D|ORR was defined as the percentage of participants in the analysis population who experienced a CR (disappearance of all target lesions) or a PR (at least a 30% decrease in the sum of diameters of target lesions) and was assessed by Investigator evaluation. The percentages of participants who experienced a CR or PR in Cohorts A, B, C and D based on Investigator assessment are presented. ORR per Investigator assessment is presented for Cohort B2 in a separate outcome measure.|Every 8 weeks until disease progression (Up to approximately 34 months)|The population consisted of all Cohort A, B, C and D participants who received ≥1 dose of study treatment.||Percentage of Participants||95% Confidence Interval|Number
660998|NCT01848834|Secondary|Overall RECIST 1.1 Response Rate Based on BICR Review, for Participants Previously Treated With Cetuximab and Platinum in Cohorts B and B2|ORR was defined as the percentage of participants in the analysis population who experienced a CR (disappearance of all target lesions) or a PR (at least a 30% decrease in the sum of diameters of target lesions) and was assessed using RECIST 1.1 based on BICR evaluation. The percentage of participants who were previously treated with cetuximab and platinum and experienced a CR or PR in the Cohorts B and B2 is presented. ORR per RESIST 1.1 based on BICR review is presented for the other cohorts in separate outcome measures.|Every 8 weeks until disease progression (Up to approximately 27 months)|The population consisted of all Cohort B or B2 participants who progressed following cetuximab and platinum therapy and received ≥1 dose of study treatment.||Percentage of Participants||95% Confidence Interval|Number
660999|NCT01848834|Secondary|Overall RECIST 1.1 Response Rate Based on BICR Review, Cohort D Asia-Pacific (AP) Participants|ORR was defined as the percentage of participants in the analysis population who experienced a CR (disappearance of all target lesions) or a PR (at least a 30% decrease in the sum of diameters of target lesions) and was assessed using RECIST 1.1 based on BICR evaluation. The percentage of participants who were from the Asia Pacific region and experienced a CR or PR in Cohort D is presented. ORR per RESIST 1.1 based on BICR review is presented for the other cohorts in separate outcome measures.|Every 8 weeks until disease progression (Up to approximately 30 months)|The population consisted of all Cohort D AP participants who received ≥1 dose of study treatment.||Percentage of Participants||95% Confidence Interval|Number
661433|NCT01840943|Secondary|Maximum Plasma Concentration of CAELYX||0 hour, 30 minutes, 90 minutes, 2 hours, 4 hours, 8 hours, 12 hours, Day 2, Day 3, Day 5, Day 8, and Day 11 for Cycle 1 and Cycle 2|Data was not collected for this outcome measure as the study was early terminated.|||||
661000|NCT01848834|Secondary|Overall RECIST 1.1 Response Rate Based on BICR Review, Cohorts B and B2 HPV-positive Participants|ORR was defined as the percentage of participants in the analysis population who experienced a CR (disappearance of all target lesions) or a PR (at least a 30% decrease in the sum of diameters of target lesions) and was assessed using RECIST 1.1 based on BICR evaluation. The percentage of participants who had tumors which were HPV positive and who experienced a CR or PR in the combined Cohorts B2 and B2 is presented. ORR per RESIST 1.1 based on BICR review is presented for the other cohorts in a separate outcome measure.|Every 8 weeks until disease progression (Up to approximately 27 months)|The population consisted of all Cohort B and Cohort B2 HPV-positive participants who received ≥1 dose of study treatment.||Percentage of Participants||95% Confidence Interval|Number
661001|NCT01848834|Primary|Overall RECIST 1.1 Response Rate Based on BICR Review for Participants in Cohort B2|ORR was defined as the percentage of participants in the analysis population who experienced a CR (disappearance of all target lesions) or a PR (at least a 30% decrease in the sum of diameters of target lesions) and was assessed using RECIST 1.1 based on BICR evaluation. The percentage of participants who experienced a CR or PR in Cohort B2 is presented. ORR per RESIST 1.1 based on BICR review is presented for the other cohorts in a separate outcome measure.|Every 8 weeks until disease progression (Up to approximately 14 months)|The population consisted of all Cohort B2 participants who received ≥1 dose of study treatment.||Percentage of Participants||95% Confidence Interval|Number
661002|NCT01848834|Primary|Overall Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Response Rate Based on Blinded Independent Central Radiology (BICR) Review (Cohorts A, B & B2, C, and D)|Overall Response Rate (ORR) was defined as the percentage of participants who experienced a Complete Response (CR; disappearance of all target lesions) or a Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions) and was assessed using RECIST 1.1 based on BICR evaluation. The percentages of participants who experienced a CR or PR for Cohort A, Cohorts B and B2 participants, Cohort C and Cohort D are presented. Cohorts A, B, C and D enrolled participants with programmed cell death-ligand 1 (PD-L1) positive tumors; Cohort B2 enrolled participants regardless of PD-L1 expression.|Every 8 weeks until disease progression (Up to approximately 34 months)|The population consisted of all Cohort A, B, B2, C and D participants who received ≥1 dose of study treatment.||Percentage of Participants||95% Confidence Interval|Number
661003|NCT01848834|Primary|Number of Participants Discontinuing From Study Treatment Due to an AE|An AE was defined as any untoward medical occurrence in a participant administered a study treatment which did not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of study treatment, was also an AE. The number of participants who discontinued study treatment due to an AE is presented. Some cases of clinical progression that led to discontinuation of study treatment were captured as AEs that led to discontinuation of study treatment.|Up to last dose of study treatment (Up to approximately 31 months)|The population consisted of all participants who received ≥1 dose of study treatment.||Participants|||Number
661004|NCT01848834|Primary|Number of Participants Experiencing Adverse Events (AEs)|An AE was defined as any untoward medical occurrence in a participant administered a study treatment which did not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of study treatment, was also an AE. The number of participants who experienced at least one AE is presented.|Serious AEs: Up to 90 days after last dose of study treatment (Up to 34 months); nonserious AEs: Up to 30 days after last dose of study treatment (Up to 32 months)|The population consisted of all participants who received ≥1 dose of study treatment.||Participants|||Number
661005|NCT01848756|Secondary|Adverse Events by Severity and Relationship to Treatment|Number of patients experiencing adverse events by highest recorded severity and relationship to study tretament|Every 28 day cycle|All treated subjects||participants|||Number
661006|NCT01848756|Secondary|Ophthalmologic Changes From Baseline|Ophthalmologic assessments will be presented by cohort, study visit and dose. Number of subjects experiencing clinically relevant changes from baseline in any of these examinations will be presented using descriptive summary|Screening, end of Cycle 1, final visit|ll Treated Subjects||participants|||Number
661007|NCT01848756|Secondary|Changes in Vital Signs, Physical Examination or Clinical Laboratory From Baseline|Descriptive summaries of vital signs, physical examination and clinical laboratory changes will be presented by treatment received.|Day 28 of each cycle|All Treated Subjects||participants|||Number
661008|NCT01848756|Secondary|Number of Patients With Adverse Events|Number of patients experiencing treatment emergent adverse events.|Day 28 of each cycle|All Treated Subjects||participants|||Number
661009|NCT01848756|Primary|Overall Survival|Time from start of treatment that patients remain alive.|Every 3 months until 24 months after the last subject has been enrolled|Due to slow recruitment and availability newer targeted treatments the study was terminated for business reasons. No patient completed 3 months on study, the first analysis time point for this endpoint, at the time of study termination|||||
661010|NCT01848756|Primary|Progression Free Survival|Time on treatment with at worst stable disease.|Every 3 months until 24 months after the last subject has been enrolled|Due to slow recruitment and availability newer targeted treatments the study was terminated for business reasons. No patient completed 3 months on study, the first analysis time point for this endpoint, at the time of study termination|||||
661011|NCT01848756|Primary|Objective Response Rate|The effect of SNX-5422 on tumor progression. Objective tumor responses (complete remissions plus partial remissions) and clinical benefit rate (complete remissions plus partial remissions plus stable disease at 6 months) will be listed by subject. Tumor measurements made using Response Evaluation Criteria in Solid Tumors (RECIST).|Up to 24 months from last patient entry|Per protocol population including all enrolled evaluable subjects.Due to slow recruitment and availability newer targeted treatments the study was terminated for business reasons. No patient completed 6 months on study, the first analysis time point for this endpoint, at the time of study termination|||||
661012|NCT01848366|Primary|Global Response Assessment (GRA)|The GRA will be used to assess for changes in urinary condition and symptoms after 12 weekly BIOWAVE treatments. The GRA asks the participant to indicate how their condition or symptoms have changed compared to when they started the study. Eight questions addressed bladder symptoms, urine leakage related to activity, urine leakage associated with urge, urinary frequency, Interstitial Cystitis/Painful Bladder Syndrome (IC/BPS), fecal incontinence, and irritable bowel syndrome. Responses range from 1=Markedly Worse to 7=Markedly Improved.|3 months|||units on a scale||Full Range|Mean
661013|NCT01848288|Secondary|Aspiration Time|Aspiration Time indicated the amount of time the system was aspirating during the removal of the cataractous lens. A lower value indicates that the surgeon spent less time aspirating fluid and material from the eye during surgery.|Day 0 (operative day), each eye|This analysis population includes all participants who were randomized to a surgical system and had non-missing values at the specific time point for each arm group, respectively.||seconds||Standard Error|Least Squares Mean
661014|NCT01848288|Primary|Aspiration (ASP) Fluid Used|Aspiration fluid used is the amount of aspiration fluid used during the removal of the cataractous lens. A lower value indicates that less fluid was removed from the eye.|Day 0 (operative day), each eye|This analysis population includes all participants who were randomized to a surgical system and had non-missing values at the specific time point for each arm group, respectively.||grams||Standard Error|Least Squares Mean
661015|NCT01848288|Primary|Cumulative Dissipated Energy|Cumulative Dissipated Energy (CDE) is an estimation of the energy at the incision site experienced during the removal of cataractous lens and is measured in %-secs. The incision is defined as 5.6mm back from the cutting edge of the tip. A lower CDE indicates that less energy was present at the incision site.|Day 0 (operative day), each eye|This analysis population includes all participants who were randomized to a surgical system and had non-missing values at the specific time point for each arm group, respectively.||percent-seconds||Standard Error|Least Squares Mean
661016|NCT01848210|Secondary|Number of Participants With Adverse Events (AEs)|Adverse events are any unwanted medical occurrences in an individual taking part in a clinical study who is receiving a pharmaceutical product. The adverse event does not have necessarily a causal relationship with the treatment. In this definition, any adverse or unwanted signals and symptoms, or findings that appear from the start or that deteriorate during the clinical study are also included, i.e. any intercurrent diseases (recently diagnosed concomitant diseases or symptoms), accidents and clinically relevant changes in clinical laboratory values.|Baseline to Week 16|Safety Population included all randomized participants who received study drug and had a least one post-Baseline safety assessment.||participants|||Number
661017|NCT01848210|Secondary|Overall Assessment by the Investigator|The investigator recorded their impression of the overall clinical picture at the end of the treatment period (Week 16), taking into account the clinical picture compared with the Baseline visit. Data is reported for the percentage of participants in each of the following assessment categories: worsening, unchanged, discreet improvement or accentuated improvement.|Baseline and Week 16|Participants from the ITT population, all eligible participants who received study drug and had at least one efficacy assessment at Visit 1 (28 ± 5 days after start of treatment), with data available for analysis.||percentage of participants|||Number
661018|NCT01848210|Secondary|Change (Reduction) From Baseline in Local Complaint Severity|"Local Complaint Severity will be assessed using the Severity Score of Local Complaints that comprises 8 items: 1=tired legs, 2=heavy legs, 3= feeling of tension, 4=feeling of swelling, 5=aching legs, 6=tingling, 7=itching, 8=burning of soles of the feet.
Each item is classified with a Likert-type scale of 5 levels, where 0=absent, 1=low, 2=medium, 3=high, 4=very high.
A total score is calculated from the sum of the scores of all the 8 items and ranges from 0 (complaints absent) to 32 (very high severity)."|Baseline and Week 16|ITT population, all participants who received study drug and had at least one efficacy assessment at Visit 1 (28 ± 5 days after start of treatment). Last observation carried forward (LOCF).||score on a scale||Standard Deviation|Mean
661019|NCT01848210|Primary|Mean Change (Reduction) From Baseline in Volume of Reference Leg at Week 16|Change in the partial volume of legs will be measured using a water plethysmometer. The volume of water (at 34 ± 0.2 °C) displaced after limb immersion is collected in an empty plastic Beaker which has been previously weighed (scale tare). The equilibrium/stability will be estimated using the absolute difference between measures of volume obtained at the Week 16 visit and Baseline to determine the reduction in edema.|Baseline and Week 16|Participants from the ITT population, all eligible participants who received study drug and had at least one efficacy assessment at Visit 1 (28 ± 5 days after start of treatment), with data available for analysis.||milliliters (mL)||Standard Deviation|Mean
661020|NCT01848145|Secondary|Number of Patients With Infusion-related Reactions Assessed According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v. 4.0.|Patients who received at least 1 dose of protocol treatment either Infusion #1 (300 mg), Infusion #2 (1000 mg) or Infusion #3 (2000 mg) are included in the assessment.|up to 28 weeks|||participants|||Number
661021|NCT01848145|Secondary|Overall Survival|Defined as the time from first treatment until death from any cause.|For 28 weeks during therapy then every 3 months for 2 years and every 6 months thereafter.|||months||95% Confidence Interval|Median
661022|NCT01848145|Secondary|Progression Free Survival|Defined as the time from first treatment until objective tumor progression or death from any cause.|For 28 weeks during therapy then every 3 months for 2 years and every 6 months thereafter.|All patients who received at least 1 dose of protocol treatment.||months||95% Confidence Interval|Median
661023|NCT01848145|Secondary|Overall Response Rate (ORR)|Defined as the percent of patients having a complete or partial response (CR or PR) assessed by International Workshop on CLL Working Group (IWCLLWG) Diagnostic Criteria (Hallek et al., 2008). CR = (a) Peripheral blood lymphocytes below 4000/µl; (b) Absence of significant lymphadenopathy by physical exam or radiographic scans (c) No hepatomegaly or splenomegaly; (d) Absence of constitutional symptoms; and blood counts above specified values. PR = (a) Decreased blood lymphocytes by 50% or more from the value prior to therapy;(b) No increase in any lymph node, and no new enlarged lymph node. Progressive Disease (PD) = An increase in 50% or more in greatest determined diameter of any previous site. Stable Disease (SD) = No evidence of CR or PR and no evidence of progressive disease.|At weeks 12 and 28|All evaluable patients. 3 patients discontinued prior to assessment.||percentage of patients|||Number
661488|NCT01838941|Secondary|Developmental Status|Denver Developmental Screening Test expressed in years and months.|6 months|The Denver Developmental Screening Test was not performed.|||||
661024|NCT01848145|Secondary|Duration of Time to Complete Individual Infusions of an Accelerated Infusion Schedule of Ofatumumab|Defined as the actual mean infusion times, in minutes, for patients to complete a schedule of 3 infusions with the goal of completing Infusion #3 within 15 minutes of the planned 2-hour treatment time.|Week 1 - Days 1 and 3, and Week 2, Day 1|Includes all treated participants. 1 participant discontinued treatment after Infusion # 1 but prior to Infusion #2. 2 participants discontinued treatment after Infusion #2 but prior to Infusion #3||minutes||Full Range|Mean
661025|NCT01848145|Primary|Percent of Patients Who Complete an Accelerated Infusion Regimen Within 15 Minutes of the Planned 2-hour Treatment.|Defined as percent of patients who are able to complete the Day 8 (2000 mg IV Ofatumumab) infusion within 15 minutes of the planned 2-hour treatment goal.|At Week 2, Day 1 of therapy|Patients who completed Infusion #3 within the 2 hour treatment goal.||percentage of participants|||Number
661026|NCT01848054|Secondary|Retention in Treatment in the Full Analysis Population|Retention in treatment at Day 3 in the full analysis population (N=310) was defined as the number of patients in each induction arm completing the induction phase and who received study medication on Day 3. Treatment with BNX sublingual tablets was considered non-inferior to generic buprenorphine if the lower limit of the 95% confidence interval for the difference between BNX and generic buprenorphine was ≥–10% in the number of patients retained in treatment on Day 3.|Day 3|Full analysis population; patients with missing data were excluded from the analysis||participants|||Number
661027|NCT01848054|Secondary|Mean Change From Baseline in the VAS Score for Cravings After Day 3 (Maintenance Phase)|"Mean change from baseline in VAS scores for cravings during the maintenance phase (Days 4, 8, 15, 22, and 29); the VAS craving scores range from 0 (no cravings) to 100 (most intense craving I have ever had)"|Pre-dose on Days 4, 8, 15, 22, and 29|Full analysis population; patients with missing data were excluded from the analysis||units on a scale||Standard Deviation|Mean
661028|NCT01848054|Secondary|Mean Change From Baseline in SOWS Total Score After Day 3 (Maintenance Phase)|Mean change from baseline in SOWS total scores during the maintenance phase (Days 4, 8, 15, 22, and 29); SOWS scores range from 0-64, with a lower score being more favorable|Pre-dose on Days 4, 8, 15, 22, and 29|Full analysis population; patients with missing data were excluded from the analysis||units on a scale||Standard Deviation|Mean
661029|NCT01848054|Secondary|Mean Change From Baseline in COWS Total Score After Day 3 (Maintenance Phase)|Mean change from baseline in COWS total scores during the maintenance phase (Days 4, 8, 15, 22, and 29); COWS scores range from 0-48, with a lower score being more favorable|Predose on Days 4, 8, 15, 22, and 29|Full analysis population; patients with missing data were excluded from the analysis||units on a scale||Standard Deviation|Mean
661030|NCT01848054|Secondary|AUC in Visual Analog Scale (VAS) Score for Craving on Days 1 to 3 Inclusive|"Least squares mean AUC measurement in VAS score for cravings on Days 1 to 3; the VAS craving scores range from 0 (no cravings) to 100 (most intense craving I have ever had)"|Pre-dose on Days 1-3 and 0.5, 1, 1.5, 3, and 6 hours post-dose on Day 1|Full analysis population; patients with missing data were excluded from the analysis and are reflected in the number of participants analyzed||score x hour||Standard Deviation|Least Squares Mean
661031|NCT01848054|Secondary|AUC in Subjective Opiate Withdrawal Scale (SOWS) Total Score on Days 1 to 3 Inclusive|Least squares mean AUC day 1 pre-dose through Day 3 in SOWS; SOWS scores range from 0-64, with a lower score being more favorable|Pre-dose on Days 1-3 and 0.5, 1, 1.5, 3, and 6 hours post-dose on Day 1|Full analysis population; patients with missing data were excluded from the analysis and are reflected in the number of participants analyzed||score x hour||Standard Deviation|Least Squares Mean
661032|NCT01848054|Secondary|Area Under the Curve (AUC) in Clinical Opiate Withdrawal Scale (COWS) Total Score on Days 1 to 3 Inclusive|Least squares mean AUC in COWS total score on Days 1 to 3; COWS scores range from 0-48, with a lower score being more favorable|Pre-dose on Days 1-3 and 0.5, 1, 1.5, 3, and 6 hours post-dose on Day 1|Full analysis population||score x hour||Standard Deviation|Least Squares Mean
661033|NCT01848054|Primary|Retention in Treatment in the Per Protocol Population|Retention in treatment at Day 3 in the per protocol population (n=256) was defined as the number of patients in each induction arm completing the induction phase and who received study medication on Day 3. Treatment with BNX sublingual tablets was considered non-inferior to generic buprenorphine if the lower limit of the 95% confidence interval for the difference between BNX and generic buprenorphine was ≥–10% in the number of patients retained in treatment on Day 3.|Day 3|Per protocol population||participants|||Number
661034|NCT01847547|Secondary|Incidence Rate of Major Gastrointestinal Bleeding|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 and procedure codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.||events per 1000 person years|||Number
661035|NCT01847547|Secondary|Incidence Rate of Major Extracranial Bleeding|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 and procedure codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.||events per 1000 person years|||Number
661036|NCT01847547|Secondary|Incidence Rate of Major Intracranial Bleeding|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.||events per 1000 person years|||Number
661037|NCT01847547|Secondary|Incidence Rate of Stroke Uncertain Classification|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.||events per 1000 person years|||Number
661038|NCT01847547|Secondary|Incidence Rate of Hemorrhagic Stroke|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.||events per 1000 person years|||Number
661039|NCT01847547|Secondary|Incidence Rate of Ischemic Stroke|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.||events per 1000 person years|||Number
661040|NCT01847547|Secondary|Incidence Rate of Systemic Embolism|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.||events per 1000 person years|||Number
661041|NCT01847547|Secondary|Incidence Rate of Stroke or Systemic Embolism|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.||events per 1000 person years|||Number
661042|NCT01847547|Secondary|Incidence Rate of Major Upper Gastrointestinal Bleeding|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 and procedure codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.||events per 1000 person years|||Number
661043|NCT01847547|Secondary|Incidence Rate of Transient Ischemic Attack|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.||events per 1000 person years|||Number
661044|NCT01847547|Secondary|Incidence Rate of Major Other Bleeding|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.||events per 1000 person years|||Number
661045|NCT01847547|Secondary|Incidence Rate of Major Urogenital Bleeding|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.||events per 1000 person years|||Number
661046|NCT01847547|Secondary|Incidence Rate of Major Lower Gastrointestinal Bleeding|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.||events per 1000 person years|||Number
661047|NCT01847547|Secondary|Incidence Rate of Pulmonary Embolism|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.||events per 1000 person years|||Number
661048|NCT01847547|Secondary|Incidence Rate of Deep Vein Thrombosis|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.||events per 1000 person years|||Number
661049|NCT01847547|Secondary|Incidence Rate of Venous Thromboembolism|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.||events per 1000 person years|||Number
661050|NCT01847547|Secondary|Incidence Rate of Myocardial Infarction|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.||events per 1000 person years|||Number
661051|NCT01847547|Primary|Incidence Rate of Major Bleeding|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 and procedure codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.||events per 1000 person years|||Number
661052|NCT01847547|Primary|Incidence Rate of Stroke|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.||events per 1000 person years|||Number
661053|NCT01847443|Primary|Cmax of Nicotine 4 mg Test and Reference Product|Cmax for 4 mg test was compared with 4 mg reference gum|Blood samples to be collected from baseline to 12 hours post-dose|Bioequivalence evaluable subjects' population: participants randomized to 1 of 4 treatment sequences; took atleast one dose of study medication (both test and reference) in 2 mg dose and/or in 4 mg doses; did not have any adverse event assimilated to vomiting in first 4 h post-treatment; and did not have baseline nicotine concentration >5% of Cmax.||ng/mL||Standard Deviation|Mean
661054|NCT01847443|Primary|Maximum Observed Concentration (Cmax) of Nicotine 2 mg Test and Reference Product|Cmax for 2 mg test was compared with 2 mg reference gum|Blood samples to be collected from baseline to 12 hours post dose|Bioequivalence evaluable subjects' population: participants randomized to 1 of 4 treatment sequences; took atleast one dose of study medication (both test and reference) in 2 mg dose and/or in 4 mg doses; did not have any adverse event assimilated to vomiting in first 4 h post-treatment; and did not have baseline nicotine concentration >5% of Cmax.||ng/mL||Standard Deviation|Mean
661055|NCT01847443|Primary|AUC(0-t) of Nicotine 4 mg Test and Reference Product|AUC(0-t) of Nicotine 4 mg test was compared with 4 mg reference gum|Blood samples to be collected from baseline to 12 hours post dose|Bioequivalence evaluable subjects' population: participants randomized to 1of 4 treatment sequences; took atleast one dose of study medication (both test and ref) in 2 mg dose and/or in 4 mg doses; did not have any AE assimilated to vomiting in first 4h post-treatment; and did not have baseline nicotine concentration >5% of Cmax.||hr*ng/mL||Standard Deviation|Mean
661081|NCT01846741|Secondary|Assess Percent Changes in Antiepileptic Drug (AED) Load From Baseline|"AED load were collected and measured from baseline.The AED load is calculated as the sum of all ratios of the total daily dose of each medication taken on the day of the visit over the defined daily dose of the medication for the main indication according to the WHO database.
Positive median value indicates increased drug load."|Up to 18 Month Visit-End of Study|ITT Population||Percent Change||Full Range|Median
661056|NCT01847443|Secondary|Area Under Concentration-time Curve From Time 0 Extrapolated to ∞ [AUC(0-∞)] of Nicotine 2 mg Test and Reference Products, and Nicotine 4 mg Test and Reference Products|AUC(0-∞) for 2mg test was compared with 2 mg reference gum, and 4 mg test was compared with 4 mg reference gum|Blood samples to be collected from baseline to 12 hours post dose|Bioequivalence evaluable subjects' population: participants randomized to 1 of 4 treatment sequences; took atleast one dose of study medication (both test and reference) in 2 mg dose and/or in 4 mg doses; did not have any adverse event assimilated to vomiting in first 4 h post-treatment; and did not have baseline nicotine concentration >5% of Cmax.||hr*ng/mL||Standard Deviation|Mean
661057|NCT01847443|Secondary|Apparent Terminal Elimination Rate Constant (Kel) of Nicotine 2 mg Test and Reference Products, and Nicotine 4 mg Test and Reference Products|Kel for 2 mg test was compared with 2 mg reference gum, and 4 mg test was compared with 4 mg reference gum|Blood samples to be collected from baseline to 12 hours post dose|Bioequivalence evaluable subjects' population: participants randomized to 1 of 4 treatment sequences; took atleast one dose of study medication (both test and reference) in 2 mg dose and/or in 4 mg doses; did not have any adverse event assimilated to vomiting in first 4 h post-treatment; and did not have baseline nicotine concentration >5% of Cmax.||1/hr||Full Range|Median
661058|NCT01847443|Secondary|Apparent Terminal Elimination Half-life (T1/2) of Nicotine 2 mg Test and Reference Products, and Nicotine 4 mg Test and Reference Products|T1/2 of 2 mg test was compared with 2 mg reference gum, and 4 mg test was compared with 4 mg reference gum|Blood samples to be collected from baseline to 12 hours post dose|Bioequivalence evaluable subjects' population: participants randomized to 1 of 4 treatment sequences; took atleast one dose of study medication (both test and reference) in 2 mg dose and/or in 4 mg doses; did not have any adverse event assimilated to vomiting in first 4 h post-treatment; and did not have baseline nicotine concentration >5% of Cmax.||hr||Full Range|Median
661059|NCT01847443|Secondary|Time to Maximum Observed Concentration (Tmax) of Nicotine 2 mg Test and Reference Products, and Nicotine 4 mg Test and Reference Products|Tmax for 2 mg test was compared with 2 mg reference gum, and 4 mg test was compared with 4 mg reference gum|Blood samples to be collected from baseline to 12 hours post dose|Bioequivalence evaluable subjects' population: participants randomized to 1 of 4 treatment sequences; took atleast one dose of study medication (both test and reference) in 2 mg dose and/or in 4 mg doses; did not have any adverse event assimilated to vomiting in first 4 h post-treatment; and did not have baseline nicotine concentration >5% of Cmax.||hr||Full Range|Median
661060|NCT01847443|Primary|Area Under the Curve From Time 0 to Time 't' [AUC(0-t)] of Nicotine 2 mg Test and Reference Product|AUC(0-t) for 2 mg test was compared with 2 mg reference gum|Blood samples to be collected from baseline to 12 hours post dose|Bioequivalence evaluable subjects' population: participants randomized to 1 of 4 treatment sequences; took atleast one dose of study medication (both test and reference) in 2 mg dose and/or in 4 mg doses; did not have any adverse event assimilated to vomiting in first 4 h post-treatment; and did not have baseline nicotine concentration >5% of Cmax.||hr*ng/mL||Standard Deviation|Mean
661061|NCT01847430|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs).|Serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination.|During the entire study period (Day 0 to Month 1)|Analysis was performed on the Total Vaccinated cohort which included all subjects who received the challenge dose of HBV vaccine.||Participants|||Number
661062|NCT01847430|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs).|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 31-day (Days 0-30) follow-up period after the challenge dose|Analysis was performed on the Total Vaccinated cohort which included all subjects who received the challenge dose of HBV vaccine.||Participants|||Number
661063|NCT01847430|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache and fever [axillary temperature above 37.5 degrees Celsius (°C)]. Gastrointestinal symptoms included nausea, vomiting, diarrhoea and/or abdominal pain. Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature above 39.0°C|During the 4-day (Days 0-3) follow-up period after the challenge dose|Analysis was performed on the Total Vaccinated cohort which included all subjects who received the challenge dose of HBV vaccine.||Participants|||Number
661064|NCT01847430|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as significant pain at rest that prevented normal everyday activities. Grade 3 redness and swelling was greater than 50 millimeters (mm) i.e. >50 mm.|During the 4-day (Days 0-3) follow-up period after the challenge dose|Analysis was performed on the Total Vaccinated cohort which included all subjects who received the challenge dose of HBV vaccine.||Participants|||Number
661065|NCT01847430|Secondary|Number of Subjects With an Anamnestic Response to the Challenge Dose in Relation to Their Pre Vaccination Status.|"Anamnestic response to the challenge dose was defined as:
At least (i.e. greater than or equal to ) 4-fold rise in post-vaccination anti-HBs antibody concentrations in subjects seropositive at the pre-vaccination time point Post-vaccination anti-HB antibody concentrations ≥10 mIU/mL in subjects seronegative at the pre-vaccination time point"|Prior to vaccination with the challenge dose|The analysis was performed on the according-to-protocol (ATP) cohort of immunogenicity on all evaluable subjects who had received a challenge dose of HBV and for whom data concerning immunogenicity outcome measures were available at the time point after the HBV challenge dose.||Participants|||Number
661109|NCT01846416|Secondary|Minimum Plasma Concentration (Cmin) for Atezolizumab||Pre-dose (0 hour) on Day 1 of Cycles 2, 3, 4, 8, and 16|Pharmacokinetic- evaluable population. Here, Number of participants analyzed = number of participants with available data for this outcome, and n= number of participants with available data at the specified time point. Per planned analysis, pharmacokinetic data were not analyzed separately for each cohort.||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
661066|NCT01847430|Secondary|Antibody Titers Against Hepatitis B Virus|Antibody titers were summarized by geometric mean concentrations (GMCs) with their 95% CIs.|Before (Day 0) and one month (Month 1) after the challenge dose|The analysis was performed on the according-to-protocol (ATP) cohort of immunogenicity on all evaluable subjects who had received a challenge dose of HBV and for whom data concerning immunogenicity outcome measures were available at the time point after the HBV challenge dose.||mIU/mL||95% Confidence Interval|Geometric Mean
661067|NCT01847430|Secondary|Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above the Cut Off Value.|The cut-off values defined were ≥ 6.2 mIU/mL, ≥ 10 mIU/mL and ≥ 100 mIU/mL.|Before (Day 0) and one month after the challenge dose (Month 1)|The analysis was performed on the according-to-protocol (ATP) cohort of immunogenicity on all evaluable subjects who had received a challenge dose of HBV and for whom data concerning immunogenicity outcome measures were available at the time point after the HBV challenge dose.||Participants|||Number
661068|NCT01847430|Primary|Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above the Cut Off Value.|The cut-off value was defined as 100 milli-international units per milliliter (mIU/mL).|One month after the challenge dose (Month 1)|The analysis was performed on the according-to-protocol (ATP) cohort of immunogenicity on all evaluable subjects who had received a challenge dose of HBV and for whom data concerning immunogenicity outcome measures were available at the time point after the HBV challenge dose.||Participants|||Number
661069|NCT01847196|Secondary|Device Performance||From the time of Angel® Catheter insertion through Angel® Catheter removal, for up to 30 days|||device malfunctions|||Number
661070|NCT01847196|Primary|Number of Adverse Events Occuring for All Evaluable Subjects|All Adverse Events (AEs) occurring throughout the study will be identified and characterized by seriousness, relationship to the investigational device and/or procedure, and whether un/anticipated.|From the time of subject enrollment through study exit (7 days post-removal or hospital discharge, whichever occurs first), for up to 37 days|||participants|||Number
661071|NCT01847131|Secondary|The Numbers of Subjects Who Developed Rhinitis Medicamentosa After Using Oxymetazoline|Rhinitis medicamentosa is the rebound nasal congestion after prolonged use (>7 days) of topical nasal decongestant (eg. oxymetazoline). However, a previous study by Baroody FM et al (J Allergy Clin Immunol 2011;127:927-34) showed that using oxymetazoline together with intranasal steroid for 1 month did not increase rhinitis medicamentosa compared to placebo. So we give rhinitis patients in the treatment group with oxymetazoline and intranasal steroid for 1 month, then stop using oxymetazoline and come back for the last visit 2 weeks later to see which patients develop rebound nasal congestion (rhinitis medicamentosa).|6 weeks|||participants|||Number
661072|NCT01847131|Primary|Effectiveness of Oxymetazoline in the Treatment of Rhinitis With Persistent Nasal Obstruction|Primary outcome measure is the nasal congestion score measuring by visual analog scale (VAS) ranging from 1-10 (0 = no symptom and 10 = the most severe symptom) compared between treatment group and controlled group.|6 weeks|||units on a scale||95% Confidence Interval|Geometric Mean
661073|NCT01846741|Secondary|Assess Changes in Healthcare Utilization: Number of Phone Calls to Physician|At baseline and each follow-up visit, subjects completed a healthcare utilization questionnaire to report the number of phone calls to physicians.|Up to 18 Month Visit-End of Study|ITT Population||Phone Calls||Full Range|Median
661074|NCT01846741|Secondary|Assess Changes in Healthcare Utilization: Number of Hours Per Week Caregivers Spent Caring for Patients.|At baseline and each follow-up visit, subjects completed a healthcare utilization questionnaire to report the number of hours per week caregivers spent caring for patients.|Up to 18 Month Visit-End of Study|ITT Population||Hours Per Week||Full Range|Median
661075|NCT01846741|Secondary|Assess Changes in Healthcare Utilization: Days Per Week Patients and Caregivers Could Not Work|At baseline and each follow-up visit, subjects completed a healthcare utilization questionnaire to report the number of days per week of missed work because of health reasons.|Up to 18 Month Visit-End of Study|ITT Population||Days Per Week||Full Range|Median
661076|NCT01846741|Secondary|Assess Changes in Healthcare Utilization: Number of Nights Spent at the Hospital|At baseline and each follow-up visit, subjects completed a healthcare utilization questionnaire to report the number of nights spent at the hospital.|Up to 18 Month Visit-End of Study|ITT Population||Nights||Full Range|Median
661077|NCT01846741|Secondary|Assess Changes in Healthcare Utilization: Inpatient Hospital Visits, Emergency Room Visits, Outpatient Hospitalizations and Physician Office Visits.|At baseline and each follow-up visit, subjects completed a healthcare utilization questionnaire to report the number of unplanned inpatient hospitalizations, emergency room visits, outpatient hospitalizations, physician office visits.|Up to 18 Month Visit-End of Study|ITT Population||Visits||Full Range|Median
661078|NCT01846741|Secondary|Evaluation of Human Factors and Usability of the AspireSR® VNS Therapy® System.|"Usability survey data were collected from all site personnel who used the handheld programmer to evaluate the usability of the AspireSR® VNS Therapy® System.The device usability survey contained 17 questions that measure usability on a five-point Likert scale ranging from “Extremely Difficult” (5) to “Extremely Easy” (1). Site personnel were asked to assess usability of the software features, instructions for use, training materials, and overall usability of the system at four different time points. The time points include implant/recovery, the first day of EMU, the end of EMU, and the 6 month follow-up visit.
Overall Usability was calculated as percentage of the users who found the overall usability of system to be easy-2 or extremely easy-1."|Up to 6 Month Visit|ITT Population||Percentage of Participants Rated 1 or 2|||Number
661079|NCT01846741|Secondary|Assess All Adverse Events to Outline the Tolerability Profile of the AspireSR® VNS Therapy® System|All adverse events (AEs) occurring during the study were collected and incidence rates tabulated by System Organ Class and Preferred Term utilizing MedDRA version 16.1 dictionary. The incidence profile was used to assess differences in near term tolerability rates relative to standard VNS Therapy.|From initial titration visit (approximately 2 weeks after implantation) up to End of Study|ITT Population||Number of Participants|||Number
661080|NCT01846741|Primary|Estimate the Effect Size Associated With Objective Measures and Patient Self-reports of Clinical Outcomes Including Seizure Frequency, Seizure Severity, Seizure Duration, Seizure Intensity, and Post-ictal Duration.|The purpose for determining the effect size was to power a stage 2 study. At the conclusion of stage 1 of the E-37 study, it was determined that another study would not be necessary as it would not provide incremental clinical benefit information above what has already been collected. Therefore, computation of effect size was not necessary.|Up to 18 Month Visit-End of Study||||||
661082|NCT01846741|Secondary|Assess Changes From Baseline in Seizure Frequency|Seizure frequency was calculated at 3, 6,12 and 18 month follow-up visits based on seizure diary information and compared to baseline estimates. Response rate was computed and summarized for partial seizures (SPS, CPS and CPS with 2nd GTCs) and overall seizure types as the proportion of patients that achieved ≥50% seizure reduction per month from baseline by visit.|Up to 18 Month Visit-End of Study|ITT Population||Percentage of Participants||95% Confidence Interval|Number
661083|NCT01846741|Secondary|Assess Changes From Baseline in Quality of Life Based on Patient Completed Questionnaire (QOLIE-31-P)|"Adult subjects (18 years and older) completed the Quality of Life in Epilepsy-Patient-Weighted (QOLIE-31-P) survey questionnaire at screening and safety follow-up visits. The range for QOLIE-31-P (Sub-domains) scale is 0-100. The higher the score the better quality of life.
Mean QOLIE-31-P scores at 3, 6, 12 and 18 months were compared to baseline. MIC Thresholds as defined in Simon Borghs, Christine de la Loge, Joyce A. Cramer, defining minimally important change in QOLIE-31-P scores."|Up to 18 Month Visit-End of Study|ITT Population||Units on a Scale||Standard Deviation|Mean
661084|NCT01846741|Secondary|Assess Changes in Seizures Severity, Intensity & Post-Ictal Recovery Based on Patient Completed Questionnaire (SSQ)|"Clinical outcomes such as seizure severity, intensity and post-ictal duration were also assessed during the long-term follow-up visits (3, 6, 12, 18 months) with patient reported questionnaires (SSQ; Seizure Severity Questionnaire). The range for SSQ (all sub-scores) is 1-7 with 1 being the least severe and 7 being the most severe.
Mean SSQ scores at 3, 6, 12 and 18 months were compared to baseline. A change from baseline is calculated as baseline minus follow-up visit score to correspond to the Minimally Important Change (MIC) criteria as defined in the Scoring Scheme for SSQ v2. Questionnaire."|Up to 18 Month Visit-End of Study|ITT Population||Units on a Scale||Standard Deviation|Mean
661085|NCT01846741|Secondary|Assesses Changes in Seizure Severity Based on Physician Reported Questionnaire (NHS3)|"Investigators completed the National Hospital Seizure Severity Scale (NHS3) questionnaire at screening, at the end of the EMU stay (provided a seizure occurred during the EMU stay), and at follow‐up visits. Severity was evaluated by seizure type. The range of NHS3 scale is 1-27 with 1 being the least severe and 27 being the most severe.
Negative median value means improvement."|Up to 18 Month Visit-End of Study|ITT Population||units on a scale||Full Range|Median
661086|NCT01846741|Secondary|Assess Characterization of Seizures (Duration and Cessation)|Clinical outcomes including seizure duration and cessation were assessed with vEEG during EMU stay. Number of seizures treated with Automatic Stimulation during EMU were evaluated. Of these seizures, those ending during the 60 second course of Automatic Stimulation were assessed and tabulated by seizure type.|Epilepsy Monitoring Unit (EMU) Stay|ITT Population||Percent of Seizures Ended During Stim|Participants||Number
661087|NCT01846741|Secondary|Assess Non-seizure Related Stimulation Rate Per Hour During EMU Stay and Stair Stepper Exercise Periods|"Each day in the EMU, subjects exercised for up to 3 minutes stepping up and down at a submaximal effort level on a step stool. Subject's resting heart rate was compared with the calculated 85% of the patient’s age-predicted maximum heart rate. This calculated heart rate was then used as termination criteria for the step test.
Non-Seizure Detection Rate (previously known as Potential False Positive Rate) is defined as the total number of non-seizure detections summed for the group divided by the total evaluable monitoring time during the EMU. The non-seizure detection rate per hour was calculated at the various tachycardia detection settings for all subjects during EMU and during exercise activities (stair stepper)."|Epilepsy Monitoring Unit (EMU) Stay|ITT Population. 5 participants analyzed for >=70%, 4 for >=60% setting, 8 for >=50% setting, 2 for >=40% setting, 1 for the >=30% setting.||detections per hour||95% Confidence Interval|Number
661088|NCT01846741|Secondary|Assess Performance of the Tachycardia Detection Algorithm (Sensitivity) During an EMU Stay Based on ITT Population-Modeled|"Sensitivity is defined as the total number of seizures detected divided by the total number of seizures during the EMU stay. Data used to support sensitivity analyses included digital ECG/EEG files, corresponding M106 device downloads, and CRF data. Seizure onset times were compared with modeled M106 device detections at the least sensitive setting capable of detecting the seizure based on the corresponding change in heart rate. The participants' surface ECG data collected during the trial and passed through DMSDAT, a validated bench‐top simulant of the Automatic Stimulation feature, was used to produce modeled results for each threshold for AutoStim setting (1;70%, 2;60%, 3;50%, 4;40%, 5;30% and 6;20%). Number of participants is total number of subjects who experienced seizures during the EMU stay.
Bootstrap confidence intervals using 3000 bootstrap samples."|Epilepsy Monitoring Unit (EMU) Stay|ITT Population (Investigator Reported Seizures + Triple Review). N= represents total number of seizures.||Percent of True Positive Seizures||95% Confidence Interval|Number
661089|NCT01846741|Secondary|Assess Performance of the Tachycardia Detection Algorithm (Sensitivity) During an EMU Stay Based on ITT Population-Observed|"Sensitivity is defined as the total number of seizures detected divided by the total number of seizures during the EMU stay. Data used to support sensitivity analyses included digital ECG/EEG files, corresponding M106 device downloads, and CRF data. Seizure and non-seizure EEG segments were provided to independent reviewers to confirm seizure occurrence and define electrographic seizure onset times. Seizure onset times were then compared with observed M106 device detections at the least sensitive setting capable of detecting the seizure based on the corresponding change in heart rate. Threshold for AutoStim setting (1;70%, 2;60%, 3;50%, 4;40%, 5;30% and 6;20%). No subjects were assigned to settings 3 and 6 that had seizures with a corresponding heart rate increase of >= 50% and >= 20%, respectively. Number of participants is total number of subjects who experienced seizures during the EMU stay.
Bootstrap confidence intervals using 3000 bootstrap samples."|Epilepsy Monitoring Unit (EMU) Stay|ITT Population (Investigator Reported Seizures + Triple Review). N= represents total number of seizures.||Percent of True Positive Seizures||95% Confidence Interval|Number
661099|NCT01846455|Primary|Maximum Observed Plasma Concentration (Cmax) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide||before dosing (time 0; Baseline) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours after dosing|The PK population included participants without any major protocol deviations who contributed PK samples and had sufficient evaluable data for the calculation of PK parameters. Eight enrolled participants were excluded due to emesis observed within 4 hours postdose, and two due to protocol violations.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
661147|NCT01845831|Secondary|Hospital Mortality Rate|Mortality is defined as death occurring during admission.|Duration of Hospitalization (Up to 10 Days)|||participants|||Number
661090|NCT01846741|Secondary|Summary of Seizures Reported by Investigators and Triple Review|"Seizure events were recorded during the EMU stay (only Automatic Stimulation Mode aka AutoStim ON) using vEEG and ECG to evaluate tachycardia detection algorithm performance. The threshold for the AutoStim feature (20-70%) was programmed for each subject, based upon the historical ictal elevation in heart rate for that subject, requiring the corresponding heart rate elevation above that of a moving baseline window.
Number of seizures observed and reported by investigators during the EMU stay (several subjects had more than one type of seizure) were collected and also reviewed by three (3) independent and blinded reviewers for confirmation. Additionally, the reviewers identified new seizures while reviewing the study EMU stay vEEG."|Epilepsy Monitoring Unit (EMU) Stay|ITT Population: Consists of all patients in the safety population who have any EMU performance recorded data and experienced any seizures.||Number of Seizures|||Number
661091|NCT01846455|Primary|Apparent Volume of Distribution During Terminal Phase (Vz/F) of Buprenorphine and Naloxone|Apparent volume of distribution during terminal phase (only for buprenorphine and naloxone), calculated as Dose/(λz • AUC0-inf).|before dosing (time 0; Baseline) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours after dosing|The PK population included participants without any major protocol deviations who contributed PK samples and had sufficient evaluable data for the calculation of PK parameters. Eight enrolled participants were excluded due to emesis observed within 4 hours postdose, and two due to protocol violations.||Liters||Geometric Coefficient of Variation|Geometric Mean
661092|NCT01846455|Primary|Apparent Body Clearance (CL/F) of Buprenorphine and Naloxone|Apparent body clearance (only for buprenorphine and naloxone), calculated as Dose/AUC0-inf.|before dosing (time 0; Baseline) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours after dosing|The PK population included participants without any major protocol deviations who contributed PK samples and had sufficient evaluable data for the calculation of PK parameters. Eight enrolled participants were excluded due to emesis observed within 4 hours postdose, and two due to protocol violations.||L/hr||Geometric Coefficient of Variation|Geometric Mean
661093|NCT01846455|Primary|Terminal Elimination Half-life (t1/2) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide|Terminal elimination half-life, calculated as ln(2)/λz. The terminal phase elimination half-life was calculated over a period of at least 2 half-lives.|before dosing (time 0; Baseline) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours after dosing|The PK population included participants without any major protocol deviations who contributed PK samples and had sufficient evaluable data for the calculation of PK parameters. Eight enrolled participants were excluded due to emesis observed within 4 hours postdose, and two due to protocol violations.||hours||Geometric Coefficient of Variation|Geometric Mean
661094|NCT01846455|Primary|Terminal Phase Elimination Rate-Constant (λz) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide|For the determination of λz, only those data points judged to describe the terminal log-linear decline resulting in an adjusted coefficient of determination value (R2) > 0.7 were used in the regression. A minimum of 3 data points were used in calculating λz.|before dosing (time 0; Baseline) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours after dosing|The PK population included participants without any major protocol deviations who contributed PK samples and had sufficient evaluable data for the calculation of PK parameters. Eight enrolled participants were excluded due to emesis observed within 4 hours postdose, and two due to protocol violations.||1/hour||Geometric Coefficient of Variation|Geometric Mean
661095|NCT01846455|Primary|Percentage of Area Under the Concentration-time Curve From Time Zero to Infinity Due to Extrapolation (%AUCextrap) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide|"Calculated as:
(AUC0-inf - AUC0-last)/AUC0-inf * 100
AUC0-inf, apparent body clearance (CL/F), and apparent volume of distribution during terminal phase (Vz/F) would not have been reported if %AUCextrap was > 20%."|before dosing (time 0; Baseline) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours after dosing|The PK population included participants without any major protocol deviations who contributed PK samples and had sufficient evaluable data for the calculation of PK parameters. Eight enrolled participants were excluded due to emesis observed within 4 hours postdose, and two due to protocol violations.||percentage of AUC0-inf||Standard Deviation|Mean
661096|NCT01846455|Primary|Time of the Last Measureable Plasma Concentration (Tlast) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide||before dosing (time 0; Baseline) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours after dosing|The PK population included participants without any major protocol deviations who contributed PK samples and had sufficient evaluable data for the calculation of PK parameters. Eight enrolled participants were excluded due to emesis observed within 4 hours postdose, and two due to protocol violations.||hours||Full Range|Median
661097|NCT01846455|Primary|Time to Reach the Maximum Plasma Concentration (Tmax) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide||before dosing (time 0; Baseline) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours after dosing|The PK population included participants without any major protocol deviations who contributed PK samples and had sufficient evaluable data for the calculation of PK parameters. Eight enrolled participants were excluded due to emesis observed within 4 hours postdose, and two due to protocol violations.||hours||Full Range|Median
661098|NCT01846455|Primary|Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide|"The extrapolation to infinity was done using the terminal phase.
AUC0-inf = AUC0-last + Ct/λz
Where Ct was the last observed quantifiable concentration and λz was the apparent terminal phase elimination rate constant."|before dosing (time 0; Baseline) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours after dosing|The PK population included participants without any major protocol deviations who contributed PK samples and had sufficient evaluable data for the calculation of PK parameters. Eight enrolled participants were excluded due to emesis observed within 4 hours postdose, and two due to protocol violations.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
661148|NCT01845831|Secondary|Acute Renal Failure Rate|Acute renal failure is defined as a clinical diagnosis of acute renal failure with documented new-onset abnormal renal function (increment > 0.5 mg/dL from baseline).|Duration of Hospitalization (Up to 10 Days)|||participants|||Number
661100|NCT01846455|Primary|Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration (AUC0-last) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide|"AUC0-last was calculated for buprenorphine, norbuprenorphine, naloxone, and naloxone-3-β-D-glucuronide using non-compartmental analysis:
AUC0-last = AUC from time 0 to the time of the last measurable plasma concentration, calculated using the linear trapezoidal rule."|before dosing (time 0; Baseline) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours after dosing|The PK population included participants without any major protocol deviations who contributed PK samples and had sufficient evaluable data for the calculation of PK parameters. Eight enrolled participants were excluded due to emesis observed within 4 hours postdose, and two due to protocol violations.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
661101|NCT01846442|Secondary|Change From Baseline to Week 12 of Vaginal Color|To evaluate the aspect of the vaginal mucosa and the local tolerance to DHEA suppository, the vaginal color (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|The analysis was performed on the ITT Population defined as all treated subjects (who received at least one dose) with a baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Mean
661102|NCT01846442|Secondary|Change From Baseline to Week 12 of Vaginal Epithelial Surface Thickness|To evaluate the aspect of the vaginal mucosa and the local tolerance to DHEA suppository, the vaginal epithelial surface thickness(one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|The analysis was performed on the ITT Population defined as all treated subjects (who received at least one dose) with a baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Mean
661103|NCT01846442|Secondary|Change From Baseline to Week 12 of Vaginal Epithelial Integrity|To evaluate the aspect of the vaginal mucosa and the local tolerance to DHEA suppository, the vaginal epithelial integrity (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|The analysis was performed on the ITT Population defined as all treated subjects (who received at least one dose) with a baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Mean
661104|NCT01846442|Secondary|Change From Baseline to Week 12 of Vaginal Secretions|To evaluate the aspect of the vaginal mucosa and the local tolerance to DHEA suppository, the vaginal secretions (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy were analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|The analysis was performed on the ITT Population defined as all treated subjects (who received at least one dose) with a baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Mean
661105|NCT01846442|Primary|Co-primary Endpoint: Change From Baseline to Week 12 of Self-assessment of the Most Bothersome Symptom Dyspareunia|The severity of dyspareunia was evaluated by a questionnaire. The severity of dyspareunia recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|The analysis was performed on a subgroup of the ITT Population (defined as all treated subjects with a baseline and at least one post-baseline efficacy assessment) who had self-identified moderate/severe dyspareunia as their Most Bothersome Symptom of vulvovaginal atrophy (VVA) and had ≤ 5% of Superficial Cells and a vaginal pH > 5 on Day 1.||units on a scale||Standard Error|Mean
661106|NCT01846442|Primary|Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal pH.|A pH strip was applied directly to the lateral wall of the vagina using forceps. The change in color of the pH indicator strip was compared to the color chart for pH evaluation. The corresponding pH value (with one decimal) was recorded. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|The analysis was performed on a subgroup of the ITT Population (defined as all treated subjects with a baseline and at least one post-baseline efficacy assessment) who had self-identified moderate/severe pain at intercourse (Dyspareunia) as their Most Bothersome Symptom of VVA and had ≤ 5% of Superficial Cells and a vaginal pH > 5 on Day 1.||pH||Standard Error|Mean
661107|NCT01846442|Primary|Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal Cell Maturation (Percentage of Superficial Cells)|The percentage of superficial cells was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|The analysis was performed on a subgroup of the ITT Population (defined as all treated subjects with a baseline and at least one post-baseline efficacy assessment) who had self-identified moderate/severe pain at intercourse (Dyspareunia) as their Most Bothersome Symptom of VVA and had ≤ 5% of Superficial Cells and a vaginal pH > 5 on Day 1.||percentage of superficial cells||Standard Error|Mean
661108|NCT01846442|Primary|Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal Cell Maturation (Percentage of Parabasal Cells)|The percentage of parabasal cells was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|The analysis was performed on a subgroup of the ITT Population (defined as all treated subjects with a baseline and at least one post-baseline efficacy assessment) who had self-identified moderate/severe pain at intercourse (Dyspareunia) as their Most Bothersome Symptom of VVA and had ≤ 5% of Superficial Cells and a vaginal pH > 5 on Day 1.||percentage of parabasal cells||Standard Error|Mean
661149|NCT01845831|Secondary|Length of Hospital Stay|Length of hospital stay in days.|Duration of Hospitalization (Up to 10 Days)|||days||Inter-Quartile Range|Median
661110|NCT01846416|Secondary|Maximum Plasma Concentration (Cmax) for Atezolizumab||Pre-dose (0 hour) and 30 minutes after infusion on Day 1 of Cycle 1|"Pharmacokinetic- evaluable population: All treated participants with pharmacokinetic data at specified time points.
Here, Number of participants analyzed = number of participants with available data for this outcome. Per planned analysis, pharmacokinetic data were not analyzed separately for each cohort."||micrograms per milliliter (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
661111|NCT01846416|Secondary|Overall Survival (OS)|OS was defined as the time from first dose of the study drug to the time of death from any cause of the study. Participants who were still alive at the time of analysis were censored at the time of their last study assessment (for active participants) or at the last date known alive (for participants in follow-up). If no post-baseline data were available, OS was censored at the date of first treatment plus 1 day.|Baseline till death or up to 20 months, whichever occurred first|Efficacy-evaluable population.||months||95% Confidence Interval|Median
661112|NCT01846416|Secondary|Percentage of Participants With Death|Participants were followed for survival throughout the study.|Baseline till death or up to 20 months, whichever occurred first|Efficacy-evaluable population.||percentage of participants|||Number
661113|NCT01846416|Secondary|Percentage of Participants With PFS at Month 6 and Month 12 According to Modified RECIST|Percentage of participants who were progression free at Months 6 and 12 (according to modified RECIST). For TLs, progressive disease was defined as at least a 20% increase in the sum of diameters of TLs and new measurable lesions, taking as reference the smallest sum recorded since treatment started.|Months 6 and 12|Efficacy-evaluable population.||percentage of participants|||Number
661114|NCT01846416|Secondary|PFS According to Modified RECIST|PFS according to modified RECIST was defined as time from first dose of atezolizumab to first occurrence of documented disease progression or death due to any cause, as determined by investigator for participants who discontinued at first documented radiographic progression. For participants who continued beyond first documented progression and had follow-up tumor assessment or death, PFS was defined as time from first dose of atezolizumab to subsequent radiographic progression or death. For TLs, progressive disease was defined as at least a 20% increase in the sum of diameters of TLs and new measurable lesions, taking as reference the smallest sum recorded since treatment started. In event of no disease progression or documented death, PFS was censored at date of last evaluable tumor assessment.|Baseline to the first occurrence of progression or death, whichever occurs earlier (up to 20 months)|Efficacy-evaluable population.||months||95% Confidence Interval|Median
661115|NCT01846416|Secondary|Percentage of Participants With Disease Progression or Death According to Modified RECIST|For TLs, progressive disease was defined as at least a 20% increase in the sum of diameters of TLs and new measurable lesions, taking as reference the smallest sum recorded since treatment started.|Baseline to the first occurrence of progression or death, whichever occurs earlier (up to 20 months)|Efficacy-evaluable population.||percentage of participants|||Number
661116|NCT01846416|Secondary|Percentage of Participants With PFS at Month 6 and Month 12 According to RECIST v1.1|Percentage of participants who were progression free at Month 6 and 12 (based on RECIST v1.1) was reported. For TLs, progressive disease was defined as at least a 20% increase in the sum of diameter of TLs, taking as reference the smallest sum on study (nadir). For non-TLs, progressive disease was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs.|Months 6 and 12|Efficacy-evaluable population.||percentage of participants|||Number
661117|NCT01846416|Secondary|Progression-Free Survival (PFS) According to RECIST v1.1|PFS was defined as time from randomization to first occurrence of documented disease progression (based on RECIST v1.1 criteria) or death due to any cause within 30 days of the last treatment, whichever occurs earlier as determined by investigator. For TLs, progressive disease was defined as at least a 20% increase in the sum of diameter of TLs, taking as reference the smallest sum on study (nadir). For non-TLs, progressive disease was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. In event of no disease progression or documented death, PFS was censored at date of last evaluable tumor assessment. Participants with no post-baseline tumor assessments were censored at the time of first dose plus 1 day.|Baseline to the first occurrence of progression or death, whichever occurs earlier (up to 20 months)|Efficacy-evaluable population.||months||95% Confidence Interval|Median
661118|NCT01846416|Secondary|Percentage of Participants With Disease Progression or Death According to RECIST v1.1|For TLs, progressive disease was defined as at least a 20% increase in the sum of diameters of TLs, taking as reference the smallest sum on study (nadir). For non-TLs, progressive disease was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs.|Baseline to the first occurrence of progression or death, whichever occurs earlier (up to 20 months)|Efficacy-evaluable population.||percentage of participants|||Number
661119|NCT01846416|Secondary|Percentage of Participants With 6-Month Duration of Objective Response|Duration of objective response at 6 months was defined as time from initial occurrence of documented CR or PR until Month 6. For TLs, CR was defined as disappearance of all TLs. Any pathological lymph nodes, whether target or non-target, must have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in sum of diameter of TLs, taking as reference baseline sum of diameters, in absence of CR. For non-TLs, CR was defined as disappearance of all non-TLs and if applicable, normalization of tumor marker level. Participants were censored at the date of last tumor assessment.|Month 6|Efficacy-evaluable population with a confirmed objective response.||percentage of participants|||Number
661120|NCT01846416|Secondary|Duration of Objective Response According to RECIST v1.1|Duration of objective response was defined as time from initial occurrence of documented CR or PR until documented disease progression (using RECIST v1.1 as determined by investigator) or death, whichever occurred first. For TLs, CR was defined as disappearance of all TLs. Any pathological lymph nodes, whether target or non-target, must had reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in sum of diameter of TLs, taking as reference baseline sum of diameters, in absence of CR. Progressive disease was at least a 20% increase in sum of diameters of TLs, taking as reference smallest sum on study (nadir). For non-TLs, CR was defined as disappearance of all non-TLs and if applicable, normalization of tumor marker level. Progressive disease was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. Participants were censored at the date of last tumor assessment.|Baseline, and Day 1 of Cycle 1 (21-day cycle), then every 6 weeks for the first 12 months and then every 9 weeks thereafter until disease progression (up to 20 months)|Efficacy-evaluable population with a confirmed objective response.||months||95% Confidence Interval|Median
661121|NCT01846416|Secondary|Percentage of Participants With Objective Response According to RECIST Version 1.1 (v1.1)|Objective response was defined as a CR or PR, as determined by the investigator according to RECIST v1.1. For TLs, CR was defined as disappearance of all TLs. Any pathological lymph nodes, whether target or non-target, must had reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameter of TLs, taking as reference the baseline sum of diameters, in absence of CR. For non-TLs, CR was defined as disappearance of all non-TLs and if applicable, normalization of tumor marker level. Participants not meeting these criteria, including participants without at least 1 post-baseline response assessment were considered as non-responders.|Baseline, and Day 1 of Cycle 1 (21-day cycle), then every 6 weeks for the first 12 months and then every 9 weeks thereafter until disease progression (up to 20 months)|Efficacy-evaluable population.||percentage of participants||95% Confidence Interval|Number
661122|NCT01846416|Primary|Percentage of Participants With Objective Response According to Modified Response Evaluation Criteria in Solid Tumors (RECIST)|Objective response was defined as a complete response (CR) or partial response (PR), as determined by investigator according to modified RECIST criteria. Modified RECIST was derived from RECIST v1.1 conventions and immune related response criteria. CR was defined as disappearance of all tumor lesions (target lesion [TL] and non-target lesion [non-TL]) and no new measurable or unmeasurable lesions, all lymph node short axes must be less than 10 millimeters (mm), and PR was defined as at least 30 percent (%) decrease in sum of diameter of TLs, and all new measurable lesions to baseline in absence of CR, and both confirmed by consecutive assessment greater than or equal to 4 weeks from date first documented. Participants not meeting these criteria, including participants without at least one post-baseline response assessment were considered as non-responders.|Baseline, and Day 1 of Cycle 1 (21-day cycle), then every 6 weeks for the first 12 months and then every 9 weeks thereafter until disease progression (up to 20 months)|Efficacy-evaluable population; all treated participants who received at least 1 dose of atezolizumab during study.||percentage of participants||95% Confidence Interval|Number
661123|NCT01846299|Secondary|Number of Primary Reasons for Decision to Treat by Investigator|The total number of primary reasons for decisions to treat was assessed. A single participant could have had multiple primary reasons for treatment.|12 months|The safety set was used for this analysis. The safety set included randomized participants who received at least one dose of study treatment. Two participants from the sham group were included in the ranibizumab group based on the actual treatment received.||Number of primary reasons|Participants||Number
661124|NCT01846299|Secondary|Number of Participants With Re-treatments|The number of participants, administered re-treatments according to treatment frequency, was assessed. Re-treatment was defined as an administration of study medication following at least one non-missed visit where treatment was not administered in the study eye. Up to Month 12, the maximum number of retreatments was 5.|Month 6, month 12|The safety set was used for this analysis. The safety set included randomized participants who received at least one dose of study treatment. Two participants from the sham group were included in the ranibizumab group based on the actual treatment received.||Participants|||Number
661125|NCT01846299|Secondary|Number of Participants With Ranibizumab Treatments|The number of participants administered study treatments, according to treatment frequency, was assessed.|Month 12|The safety set was used for this analysis. The safety set included randomized participants who received at least one dose of study treatment. Two participants from the sham group were included in the ranibizumab group based on the actual treatment received.||Participants|||Number
661126|NCT01846299|Secondary|Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss|VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using ETDRS-like visual acuity testing charts at a testing distance of 4 meters.|Month 2, Month 6, Month 12|The full analysis set (FAS) was considered for the analysis. The FAS included all randomized participants who received at least one dose of study treatment. Only participants of the FAS, who had data at baseline and the specific post-baseline time point, were included in the analysis for that time point.||Participants|||Number
661127|NCT01846299|Secondary|Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters|VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using ETDRS-like visual acuity testing charts at a testing distance of 4 meters.|Month 2, Month 6 , Month 12|The full analysis set (FAS) was considered for the analysis. The FAS included all randomized participants who received at least one dose of study treatment. Only participants of the FAS, who had data at baseline and the specific post-baseline time point, were included in the analysis for that time point.||Participants|||Number
661128|NCT01846299|Secondary|Average Change From Baseline in BCVA|BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. A positive change from baseline indicated improvement.|Baseline (BL), month 1 through month 6, month 1 through month 12|The FAS was used for this analysis. The FAS included randomized participants who received at least one dose of study medication.||letters||Standard Deviation|Mean
661129|NCT01846299|Secondary|Number of Participants Requiring Rescue Treatment at Month 1|Rescue treatment with laser photocoagulation or periocular treatment could be administered at Month 1 only if the participant had a visual acuity loss of > 5 letters due to disease activity from baseline to Month 1.|Month 1|The FAS was used for this analysis. The FAS included all randomized participants who received at least one dose of study treatment.||Participants|||Number
661130|NCT01846299|Secondary|Number of Participants With Presence of Active Macular Edema (ME) Leakage|The presence of active ME leakage was assessed by fluorescein angiography (FA).|Month 2|The FAS was used this analysis. The FAS included randomized participants who received at least one dose of study treatment.||Participants|||Number
661131|NCT01846299|Secondary|Number of Participants With Presence or Absence of Subretinal Fluid in Study Eye Compared to Baseline|The presence of subretinal fluid was assessed by OCT.|Month 2, Month 6, Month 12|The FAS was considered for the analysis. The FAS included all randomized participants who received at least one dose of study treatment. Only participants (n), with values 'Absent' or 'Definite' for both the baseline and corresponding post-baseline time point, were included in the analysis.||Participants|||Number
661150|NCT01845831|Secondary|Total Daily Insulin Dose|Daily insulin requirement (units per day).|Duration of Hospitalization (Up to 10 Days)|||units per day||Standard Error|Mean
661132|NCT01846299|Secondary|Number of Participants With Presence or Absence of Intra-retinal Fluid in Study Eye Compared to Baseline|The presence of intra-retinal fluid was assessed by OCT.|Month 2, Month 6, Month 12|The FAS was considered for the analysis. The FAS included all randomized participants who received at least one dose of study treatment. Only participants (n), with values 'Absent' or 'Definite' for both the baseline and corresponding post-baseline time point, were included in the analysis.||Participants|||Number
661133|NCT01846299|Secondary|Change From Baseline in Central Subfield Volume (CSFV) in Study Eye|CSFV was assessed OCT. A negative change from baseline indicates improvement.|Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12|The full analysis set (FAS) was considered for the analysis. The FAS included all randomized participants who received at least one dose of study treatment. Only participants of the FAS, who had data at baseline and the specific post-baseline time point, were included in the analysis for that time point.||microliters (ul)||Standard Deviation|Mean
661134|NCT01846299|Secondary|Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye|CSFT wasassessed by optical coherence tomography (OCT). A negative change from baseline indicates improvement.|Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12|The full analysis set (FAS) was considered for the analysis. The FAS included all randomized participants who received at least one dose of study treatment. Only participants of the FAS, who had data at baseline and the specific post-baseline time point, were included in the analysis for that time point.||micrometers (um)||Standard Deviation|Mean
661135|NCT01846299|Secondary|Change From Baseline in BCVA in Study Eye up to Month 2|BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. A positive change from baseline indicated improvement.|Baseline, Month 1, Month 2|The full analysis set (FAS) was considered for the analysis. The FAS. The FAS included all randomized participants who received at least one dose of study treatment. Only participants of the FAS, who had data at baseline and the specific post-baseline time point, were included in the analysis for that time point.||letters||Standard Error|Least Squares Mean
661136|NCT01846299|Primary|Change From Baseline in Best-corrected Visual Acuity (BCVA) in Study Eye|BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. A positive change from baseline indicated improvement.|Baseline, Month 2|Full analysis set: The full analysis set included all randomized participants who received at least one dose of study treatment.||letters||Standard Error|Least Squares Mean
661137|NCT01846104|Secondary|Number of Subjects Who Developed TNA Anti-ricin Toxin-neutralizing Antibody Titers (≥ 1:50)||Six months|All statistical analysis of immunogenicity data was conducted using 4 subjects at every time point except Day 84 and 180 (for which there were 3 subjects).||participants|||Number
661138|NCT01846104|Secondary|Number of Subjects Who Developed Total ELISA IgG Titers (≥ 1:500)||Six months|All statistical analysis of immunogenicity data was conducted using 4 subjects at every time point except Day 84 and 180 (for which there were 3 subjects).||Subjects with Total ELISA IgG (≥ 1:500)|||Number
661139|NCT01846104|Primary|Number of Vaccinated Participants Who Experienced Adverse Events by Nature and Severity.||Six months|All statistical analysis of safety data was conducted using 4 subjects at every time point except Day 180 (for which there were 3 subjects).||participants|||Number
661140|NCT01846039|Secondary|Percentage of Participants Who Would Recommend VOLUMA Treatment of the Nose to Others||Days 113, 239 and 421|Intent-to-treat population included all enrolled participants who received treatment.||percentage of participants|||Number
661141|NCT01846039|Secondary|Percentage of Participants Satisfied or Very Satisfied Based on the Treatment Satisfaction Scale (TSS)|Participants assessed their satisfaction with the study drug (VOLUMA) treatment at Days 113, 239 and 421 using the TSS 5-point scale: -2 (very dissatisfied) to 2 (very satisfied). The percentage of participants satisfied or very satisfied with study drug treatment is reported.|Days 113, 239 and 421|Intent-to-treat population included all enrolled participants who received treatment.||percentage of participants|||Number
661142|NCT01846039|Secondary|Percentage of Participants Satisfied or Very Satisfied Based on the Nose Satisfaction Scale (NSS)|Participants assessed their satisfaction with the appearance of their nose at Days 113, 239 and 421 using the NSS 5-point scale: -2 (very dissatisfied) to 2 (very satisfied). The percentage of participants who rated themselves as satisfied or very satisfied is reported.|Days 113, 239 and 421|Intent-to-treat population included all enrolled participants who received treatment.||percentage of participants|||Number
661143|NCT01846039|Secondary|Percentage of Participants With a ≥ 1 Grade Improvement on the AAIS as Assessed by the Patient|The participant evaluated the improvement of their nose as compared to Baseline using the AAIS 5-point scale: -2 (much worse) to +2 (much improved) at Days 239 and 421. The percentage of participants with a ≥ 1 grade improvement from Baseline is reported|Baseline, Days 239 and 421|Intent-to-treat population included all enrolled participants who received treatment.||percentage of participants|||Number
661144|NCT01846039|Secondary|Percentage of Participants With a ≥ 1 Grade Improvement on the AAIS as Assessed by the Central Evaluating Physician|The independent central evaluating physician evaluated the improvement of the participant’s nose compared to Baseline using the AAIS 5-point scale: -2 (much worse) to +2 (much improved) at Days 239 and 421. The percentage of participants with a ≥ 1 grade improvement from Baseline is reported.|Baseline, Days 239 and 421|Intent-to-treat population included all enrolled participants who received treatment.||percentage of participants|||Number
661145|NCT01846039|Primary|Percentage of Participants With a ≥ 1 Grade Improvement on the AAIS as Assessed by the Patient at Day 113|The participant evaluated the improvement of their nose as compared to Baseline using the AAIS 5-point scale: -2 (much worse) to +2 (much improved) at Day 113. The percentage of participants with a ≥ 1 Grade Improvement from Baseline is reported.|Baseline, Day 113|Intent-to-treat population included all enrolled participants who received treatment.||percentage of participants|||Number
661146|NCT01846039|Primary|Percentage of Participants With a ≥ 1 Grade Improvement on the Assessment of Aesthetic Improvement Scale (AAIS) as Assessed by the Central Evaluating Physician at Day 113|The independent central evaluating physician evaluated the improvement of the participant’s nose as compared to Baseline using the AAIS 5-point scale: -2 (much worse) to +2 (much improved) at Day 113. The percentage of participants with a ≥ 1 grade improvement from Baseline is reported.|Baseline, Day 113|Intent-to-treat population included all enrolled participants who received treatment.||percentage of participants|||Number
661152|NCT01845831|Primary|Change in HbA1C|The mean HbA1C measured at 3 months and 6 months post hospitalization. HbA1C is an indicator of diabetes control; below 6.0% is normal, 6.0% to 6.4% indicates prediabetes, and 6.5% or over indicates diabetes.|Post Hospital Discharge Month 3, Month 6|253 subjects who participated in the inpatient phase and were invited to complete the outpatient phase.||percent||Standard Deviation|Mean
661153|NCT01845831|Primary|Mean Percentage of Blood Glucose Readings Greater Than 13.3 mmol/L|Differences in glycemic control as measured by mean daily blood glucose (BG) concentration between sitagliptin once daily and basal bolus therapy with glargine once daily plus supplemental lispro insulin in hospitalized patients with T2D.|Duration of Hospitalization (Up to 10 Days)|||percentage of blood glucose readings||Standard Deviation|Mean
661154|NCT01845831|Primary|Mean Percentage of Blood Glucose Readings Between 5.6 - 7.8 mmol/L|Differences in glycemic control as measured by mean daily blood glucose (BG) concentration between sitagliptin once daily and basal bolus therapy with glargine once daily plus supplemental lispro insulin in hospitalized patients with T2D.|Duration of Hospitalization (Up to 10 Days)|||percentage of blood glucose readings||Standard Deviation|Mean
661155|NCT01845831|Primary|Mean Percentage of Blood Glucose Readings Between 3.9 - 10.0 mmol/L|Differences in glycemic control as measured by mean daily blood glucose (BG) concentration between sitagliptin once daily and basal bolus therapy with glargine once daily plus supplemental lispro insulin in hospitalized patients with T2D.|Duration of Hospitalization (Up to 10 Days)|||percentage of blood glucose readings||Standard Deviation|Mean
661156|NCT01845831|Primary|Mean Percentage of Blood Glucose Readings Between 3.9 - 7.8 mmol/L|Differences in glycemic control as measured by mean daily blood glucose (BG) concentration between sitagliptin once daily and basal bolus therapy with glargine once daily plus supplemental lispro insulin in hospitalized patients with T2D.|Duration of Hospitalization (Up to 10 Days)|||percentage of blood glucose readings||Standard Deviation|Mean
661157|NCT01845831|Primary|Mean Blood Glucose Concentration After First Day of Treatment|The average blood glucose (BG) concentration after the first day of treatment|Duration of Hospitalization (Up to 10 Days)|||mmol/L||Standard Deviation|Mean
661158|NCT01845220|Primary|Mean Area of Skin Erythema (Skin Redness)|For three days in a row, volunteers will receive skin treatments with broccoli sprout extract. On day four, their skin will be measured for a baseline skin color reading. Immediately following this reading, the treated areas of the skin will be challenged with 70 percent alcohol and the redness of the skin will again be measured every 30 minutes for the following two hours for skin color changes. The values were collected every 30 minutes after the alcohol skin challenge for 2 hours and were averaged. Mean and 95% Confidence Interval are reported.|mean up to 2 hours|Since experimental conditions were refined part way through the series and only the last 19 individuals' data was deemed suitable for analysis.||centimeters^2||95% Confidence Interval|Mean
661159|NCT01845155|Secondary|Change in Tinnitus Frequency (Pitch), Obtained at Admission (Pre) and After Therapy Intervention (Post)||the average time period was 3 months|||Hz||Standard Deviation|Median
661160|NCT01845155|Primary|Tinnitus Questionnaire (TQ, Goebel and Hiller 1998) Total Score Change From Baseline to End of Treatment|Tinnitus severity was assessed by the German version of the tinnitus questionnaire (TQ, Goebel and Hiller 1994). The TQ consists of a total of 52 items. The questionnaire records tinnitus related complaints on a global TQ-score. The range of values is between the minimum score of 0 and the maximum score of 84, whereas high values indicate high tinnitus related distress.|average time period was 3 months|||absolute TF-score change||Standard Deviation|Mean
661161|NCT01845103|Secondary|Major Adverse Coronary and Cerebrovascular Events (MACCE)|"MACCE includes:
Cardiac related death, CVA, Myocardial Infarction, Serious arrhythmia, CHF"|30 day|||percentage of participants|||Number
661162|NCT01845103|Primary|Mortality||30 day|||percentage of participants|||Number
661163|NCT01845077|Primary|Cmax of Metformin|Maximum Measured Concentration (Cmax) of Metformin in plasma. The shown geometric coefficients of variation (gCV) are the pooled intra-individual gCV - each over 2 treatment groups (FDC1000 fasted and L+M1000 fasted, FDC1000 fed and L+M1000 fed, FDC1500 fasted and L+M1500 fasted). The geometric means are actually adjusted geometric means.|1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period|Pharmacokinetic set including all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint without important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
661164|NCT01845077|Primary|AUC0-tz of Metformin|Area under the concentration-time curve of Metformin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). The shown geometric coefficients of variation (gCV) are the pooled intra-individual gCV - each over 2 treatment groups (FDC1000 fasted and L+M1000 fasted, FDC1000 fed and L+M1000 fed, FDC1500 fasted and L+M1500 fasted). The geometric means are actually adjusted geometric means.|1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period|Pharmacokinetic set including all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint without important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
661165|NCT01845077|Secondary|AUC0-infinity of Metformin|Area under the concentration-time curve of Metformin in plasma over the time interval from 0 extrapolated to infinity based on predicted last concentration values. The shown geometric coefficients of variation (gCV) are the pooled intra-individual gCV - each over 2 treatment groups (FDC1000 fasted and L+M1000 fasted, FDC1000 fed and L+M1000 fed, FDC1500 fasted and L+M1500 fasted). The geometric means are actually adjusted geometric means.|1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period|Pharmacokinetic set including all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint without important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
661214|NCT01844687|Other Pre-specified|Optional Additional Puffs of MJ Cigarette|Participants were allowed to choose to take or reject additional puffs of the same type of MJ cigarette they smoked earlier in the day. Counts of participants choosing to take additional puffs are reported.|150 to 250 minutes after first marijuana cigarette was smoked earlier in the day|all study completers||Participants|||Count of Participants
661166|NCT01845077|Secondary|AUC0-infinity of Linagliptin|Area under the concentration-time curve of Linagliptin in plasma over the time interval from 0 extrapolated to infinity based on predicted last concentration values. The shown geometric coefficients of variation (gCV) are the pooled intra-individual gCV - each over 2 treatment groups (FDC1000 fasted and L+M1000 fasted, FDC1000 fed and L+M1000 fed, FDC1500 fasted and L+M1500 fasted). The geometric means are actually adjusted geometric means.|1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period|Pharmacokinetic set including all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint without important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
661167|NCT01845077|Primary|Cmax of Linagliptin|Maximum Measured Concentration (Cmax) of Linagliptin in plasma. The shown geometric coefficients of variation (gCV) are the pooled intra-individual gCV - each over 2 treatment groups (FDC1000 fasted and L+M1000 fasted, FDC1000 fed and L+M1000 fed, FDC1500 fasted and L+M1500 fasted). The geometric means are actually adjusted geometric means.|1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period|Pharmacokinetic set including all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint without important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
661168|NCT01845077|Primary|AUC0-72 of Linagliptin|Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval 0 to 72 Hours (AUC0-72). The shown geometric coefficients of variation (gCV) are the pooled intra-individual gCV - each over 2 treatment groups (FDC1000 fasted and L+M1000 fasted, FDC1000 fed and L+M1000 fed, FDC1500 fasted and L+M1500 fasted). The geometric means are actually adjusted geometric means.|1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period|Pharmacokinetic set including all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint without important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
661169|NCT01845025|Secondary|Unplanned Healthcare Utilization at Visit 3 (Week 4), Visit 4 (Week 12) and Visit 5 (Week 26)|Unplanned healthcare utilization by visit (Telephone contact with study doctor (MD); Telephone contact with other physician (MD) or healthcare provider (HCP); Unscheduled or unplanned visit to study doctor (including home visits); Unscheduled or unplanned visit to other physician or healthcare provider (including home visits); Emergency department or hospital visit (< 24 hours); Hospital admission or Emergency department visit (> 24 hours).|Week 4, Week 12, and Week 26|Intent to treat (ITT) population included all randomized patients who took at least one dose (one inhalation) of study medication||unplanned visits|||Number
661170|NCT01845025|Secondary|Change From Baseline in Asthma Control Questionnaire (ACQ – 6) Total Score at Week 26|Change from baseline in Asthma control Questionnaire (ACQ – 6) total score at week 26. Results of the Asthma control questionnaire (ACQ-6); The average score of the six questions is calculated as the sum of scores divided by the number of questions that were answered at the time point, as long as there were at least 4 questions answered. The ACQ6 score is calculated as the mean of the responses to the first 6 questions of the ACQ. The ACQ is a scale containing 7 questions, each question has a 7-point scale which ranges from 0 to 6; a total score of 0 corresponds to no impairment and a total score of 6 corresponds to maximum impairment.|baseline and 26 weeks|Intent to treat (ITT) population included all randomized patients who took at least one dose (one inhalation) of study medication||total score on a scale||Standard Deviation|Mean
661171|NCT01845025|Secondary|Percentage of Days With no Symptoms at 26 Weeks|Percentage of days with no symptoms during the treatment period (26 weeks). Percentage is calculated as total number of days with no symptoms divided by total days of treatment.|26 weeks|Intent to treat (ITT) population included all randomized patients who took at least one dose (one inhalation) of study medication||percentage of days||Standard Deviation|Mean
661172|NCT01845025|Secondary|Percentage of Days With no Rescue Medication Use at 26 Weeks|Percentage of rescue free days is calculated as total number of days with no rescue medication was taken divided by total days of treatment.|26 weeks|Intent to treat (ITT) population included all randomized patients who took at least one dose (one inhalation) of study medication||percentage of days||Standard Deviation|Mean
661173|NCT01845025|Secondary|Percentage of Days With Nighttime Awakenings at 26 Weeks|Percentage of days with nighttime awakenings during the treatment period (26 weeks)|26 weeks|Intent to treat (ITT) population included all randomized patients who took at least one dose (one inhalation) of study medication||percentage of days||Standard Deviation|Mean
661174|NCT01845025|Secondary|Percentage of Days With Limited Ability to Perform Normal Daily Activities at 26 Weeks|The percentage of days with limited ability to perform normal daily activities during the treatment period (26 weeks). Percentage is calculated as total number of days when the patient had limited ability to perform normal daily activities divided by total days of treatment.|26 weeks|Intent to treat (ITT) population included all randomized patients who took at least one dose (one inhalation) of study medication||percentage of days||Standard Deviation|Mean
661175|NCT01845025|Secondary|Percentage of Days of School/Work Missed at 26 Weeks|The percentage of days of school/work missed during the treatment period (26 weeks). Overall percentage of school days missed for each student patient or of work days missed is calculated by total number of days missed divided by total days of treatment.|26 weeks|Intent to treat (ITT) population included all randomized patients who took at least one dose (one inhalation) of study medication||percentage of days||Standard Deviation|Mean
661176|NCT01845025|Secondary|Number of Asthma Exacerbations at 26 Weeks|Number of asthma exacerbations events|26 weeks|Intent to treat (ITT) population included all randomized patients who took at least one dose (one inhalation) of study medication||events||Standard Deviation|Mean
661215|NCT01844687|Other Pre-specified|Marijuana Rating Form - Strength|Subjects rated how strong the effects of the cannabis were using a visual analog scale.|15 - 120 minutes after marijuana cigarette smoking|all study completers||units on a scale||Standard Error|Mean
661216|NCT01844687|Other Pre-specified|Marijuana Rating Form - Like|Participants rated how much they liked the effects of smoked marijuana using a visual analog scale 1-100 mm, 1=least, 100= most|15 - 120 minutes after marijuana cigarette smoking|all study completers||units on a scale||Standard Error|Mean
661177|NCT01845025|Primary|Number of First Occurrence(s) of Any Composite Endpoint Including Asthma-related Hospitalizations, Intubations and Deaths During the Study at 26 Weeks|The primary safety endpoint was the number of first occurrence(s) of any composite endpoint. The composite events include asthma-related deaths, asthma-related intubations and asthma-related hospitalizations. The number of events includes all adjudication confirmed events, one patient could experience multiple events during the course of study; Event rate = 100 * n patients with any events / total N patients in treatment group.|26 weeks|Intent to treat (ITT) population included all randomized patients who took at least one dose (one inhalation) of study medication||number of occurences|||Number
661178|NCT01844895|Secondary|Number of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by Electrochemiluminescence (ECL) on Day 29 and Day 113.|Serum samples for immunogenicity were evaluated for presence of anti-abatacept antibodies using a validated bridging ECL on Day 29 and Day 113. The ECL assay differentiated between 2 antibody specificities: the immunoglobulin (Ig) G and/or junction region and cytotoxic leukocyte antigen 4 (CTLA4) and possibly Ig. A positive immunogenicity response relative to baseline was defined as: A missing baseline immunogenicity measurement and a positive analytical laboratory reported immunogenicity response post-baseline; A negative baseline immunogenicity response and a positive analytical laboratory reported immunogenicity response post-baseline; A positive baseline immunogenicity response and a positive analytical laboratory reported immunogenicity response post-baseline that has a titer value strictly greater than the baseline titer value.|Days 29 and 113|A subset of the treated analysis population for whom at least 1 immunogenicity sample was collected and assessed for serum anti-abatacept antibodies, were summarized.||participants|||Number
661179|NCT01844895|Secondary|Geometric Mean of Trough Serum Concentration (Cmin) Over Time and During the Switch From Prefilled Syringe to Autoinjector on Days 22, 29, 57, 85, 106, and 113|Abatacept SC was self-administered with a BD Hypak™ Physiolis prefilled syringe every 7 days for the first 4 weeks of the substudy until Day 29; Blood samples for PK were taken at 0 hour (predose). On substudy Day 29, participants were switched from the prefilled syringe to the autoinjector. Participants continued to self-administer abatacept with the autoinjector every 7 days following Day 29 for the remaining 3 months of the substudy. Blood samples for PK were taken at 0 hour (predose). Serum concentrations of abatacept were analyzed using a validated ELISA. Steady-state trough observed concentration in serum (Cminss) was measured in micrograms/milliliter (μg/mL).|Days 22, 29, 57, 85, 106, and 113|PK population: A subset of the treated population with at least 1 PK sample collected/assessed for serum concentration after start of autoinjector and with Cmin obtained appropriately (7 days + or -3 days after the previous dose).||μg/mL||Geometric Coefficient of Variation|Geometric Mean
661180|NCT01844895|Secondary|Geometric Mean of Area Under Serum Concentration-time (AUC) During a Dosing Interval (TAU) of Abatacept During the Sampling Period Between Days 22 and 29 for the Prefilled Syringe and Between Days 106 and Day 113 for the Autoinjector|Abatacept SC was self-administered with a BD Hypak™ Physiolis prefilled syringe every 7 days for the first 4 weeks of the substudy until Day 29; Blood samples for PK were taken on Days 1 and 22 at 0 hour (predose), Day 24 at 48 hour (h) post dose, Day 25 at 72 h post dose, Day 26 at 96 h post dose and Day 29 at 0 h (predose). On substudy Day 29, participants were switched from the prefilled syringe to the autoinjector. Participants continued to self-administer abatacept with the autoinjector every 7 days following Day 29 for the remaining 3 months of the substudy; Blood samples for PK were taken on Day 106 at 0 h (predose), Day 108 at 48 h post dose, Day 109 at 72 h post dose, Day 110 at 96 h post dose and at Day 113 0h (predose). Serum concentrations of abatacept were analyzed using a validated ELISA. AUC(TAU) where TAU = 168 hours was calculated in µg*h/mL|Days 22, 24, 25, 26,29 (prefilled syringe); Days 106, 108, 109, 110, 113 (autoinjector)|PK population: A subset of the treated population with at least 1 PK sample collected/assessed for serum concentration after start of autoinjector. Participants did not miss either 0-hour or 168-hour samples and not missed 2 or more time points in the PK profile.||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
661181|NCT01844895|Secondary|PK Analysis: Median Time to Achieve Cmax (Tmax) During the Sampling Period Between Days 22 and 29 for the Prefilled Syringe and Between Days 106 and Day 113 for the Autoinjector|Abatacept SC was self-administered with a BD Hypak™ Physiolis prefilled syringe every 7 days for the first 4 weeks of the substudy until Day 29; Blood samples for PK were taken on Days 1 and 22 at 0 hour (predose), Day 24 at 48 hour (h) post dose, Day 25 at 72 h post dose, Day 26 at 96 h post dose and Day 29 at 0 h (predose). On substudy Day 29, participants were switched from the prefilled syringe to the autoinjector. Participants continued to self-administer abatacept with the autoinjector every 7 days following Day 29 for the remaining 3 months of the substudy; Blood samples for PK were taken on Day 108 at 48 h post dose, Day 109 at 72 h post dose, Day 110 at 96 h post dose and at Day 113 0h (predose). Serum concentrations of abatacept were analyzed using a validated ELISA. Tmax was measured in hours (h).|Days 22, 24, 25, 26, 29 (prefilled syringe); Days 106, 108, 109, 110,113 (autoinjector)|PK population: A subset of the treated population with at least 1 PK sample collected/assessed for serum concentration after start of autoinjector. Participants did not miss either 0-hour or 168-hour samples and not missed 2 or more time points in the PK profile.||h||Full Range|Median
661182|NCT01844895|Secondary|PK Analysis: Geometric Mean of Maximum Observed Serum Concentration (Cmax) of Abatacept During the Sampling Period Between Substudy Days 22 and 29 for the Prefilled Syringe and Between Substudy Days 106 and Day 113 for the Autoinjector|Abatacept SC was self-administered with a BD Hypak™ Physiolis prefilled syringe every 7 days for the first 4 weeks of the substudy until Day 29; Blood samples for PK were taken on Days 1 and 22 at 0 hour (predose), Day 24 at 48 hour (h) post dose, Day 25 at 72 h post dose, Day 26 at 96 h post dose and Day 29 at 0 h (predose). On substudy Day 29, participants were switched from the prefilled syringe to the autoinjector. Participants continued to self-administer abatacept with the autoinjector every 7 days following Day 29 for the remaining 3 months of the substudy; Blood samples for PK were taken on Day 108 at 48 h post dose, Day 109 at 72 h post dose, Day 110 at 96 h post dose and at Day 113 0h (predose). Serum concentrations of abatacept were analyzed using a validated ELISA. Cmax was measured in μg/mL.|Days 22, 24, 25, 26, 29 (prefilled syringe); Days 106, 108, 109, 110, 113 (autoinjector)|PK population: A subset of the treated population with at least 1 PK sample collected/assessed for serum concentration after start of autoinjector. Participants did not miss either 0-hour or 168-hour samples and not missed 2 or more time points in the PK profile.||μg/mL||Geometric Coefficient of Variation|Geometric Mean
661183|NCT01844895|Primary|Pharmacokinetic (PK) Analysis: Adjusted Geometric Mean Observed Serum Trough Concentration at Steady State (Cminss) of Abatacept Using a Prefilled Syringe (Measured on Day 29) and Using an Autoinjector (Measured on Day 113)|Abatacept SC was self-administered with a prefilled syringe every 7 days for the first 4 weeks until Day 29; Blood samples for PK were taken pre-dose (0 hour) on Days 29 and 113. Serum concentrations of abatacept were analyzed using a validated enzyme-linked immunosorbent assay (ELISA). Steady-state trough observed concentration in serum (Cminss) was measured in micrograms/milliliter (μg/mL). Adjusted geometric mean and 90% confidence interval (CI) are presented.|Day 29, Day 113|The primary PK analysis population is a subset of the Treated Analysis population with (1) viable Cmin data on both substudy Days 29 and 113 (2) no missed Abatacept dose during the substudy period.||μg/mL||90% Confidence Interval|Geometric Mean
661184|NCT01844856|Secondary|Clinical Response of Eravacycline and Ertapenem Treatment Arms in the Clinically Evaluable (CE) Population at the TOC Visit|Clinical response was classified as cure (complete resolution or significant improvement of signs and symptoms of the index infection), failure (death related to complicated intra-abdominal infection [cIAI], unplanned surgical procedures or percutaneous drainage procedures, persisting or recurrent infection within the abdomen, postsurgical wound infection, or administration of effective concomitant antibacterial therapy), or indeterminate (outcome was neither cure nor failure, or assessment was not available). Participants who were failures at the EOT visit (within 24 hours of last dose) were considered failures at the TOC visit. The number of participants with a clinical response classification of cure, failure, or indeterminate is presented.|TOC visit: 25-31 days after first dose|All randomized participants who had no major protocol deviations (CE population).||participants|||Number
661185|NCT01844856|Secondary|Clinical Response of Eravacycline and Ertapenem Treatment Arms in the Modified Intent-to-treat (MITT) Population at the TOC Visit|Clinical response was classified as cure (complete resolution or significant improvement of signs and symptoms of the index infection), failure (death related to complicated intra-abdominal infection [cIAI], unplanned surgical procedures or percutaneous drainage procedures, persisting or recurrent infection within the abdomen, postsurgical wound infection, or administration of effective concomitant antibacterial therapy), or indeterminate (outcome was neither cure nor failure, or assessment was not available). Participants who were failures at the EOT visit (within 24 hours of last dose) were considered failures at the TOC visit. The number of participants with a clinical response classification of cure, failure, or indeterminate is presented.|TOC visit: 25-31 days after first dose|All randomized participants who received at least 1 dose of study drug (MITT population).||participants|||Number
661186|NCT01844856|Primary|Clinical Response of Eravacycline and Ertapenem Treatment Arms at the Test-of-cure (TOC) Visit in the Microbiological Intent-to-treat (Micro-ITT) Population|Clinical response was classified as cure (complete resolution or significant improvement of signs and symptoms of the index infection), failure (death related to complicated intra-abdominal infection [cIAI], unplanned surgical procedures or percutaneous drainage procedures, persisting or recurrent infection within the abdomen, postsurgical wound infection, or administration of effective concomitant antibacterial therapy), or indeterminate (outcome was neither cure nor failure, or assessment was not available). Participants who were failures at the End-of-Treatment (EOT) visit (within 24 hours of last dose) were considered failures at the TOC visit. The number of participants with a clinical response classification of cure, failure, or indeterminate is presented.|TOC visit: 25-31 days after the first dose of study drug|All randomized participants who had baseline bacterial pathogens that cause cIAI and against at least one of which the investigational drug has in vitro antibacterial activity (micro-ITT population).||participants|||Number
661187|NCT01844830|Secondary|Results of Naris Examination (NE) - Bleeding||120 minutes post drug administration|||Participants|||Count of Participants
661188|NCT01844830|Secondary|Results of Naris Examination (NE) - Inflammation||120 minutes post drug administration|||Participants|||Count of Participants
661189|NCT01844830|Secondary|Results of Naris Examination (NE) - Color|The investigators performed a visual inspection and evaluated the treatment naris for color of the mucosa. The investigator determined what color (Pink, Slightly Red, Red) best matched and recorded the results.|120 minutes post drug administration|||Participants|||Count of Participants
661190|NCT01844830|Secondary|Maximum Change From Baseline in Diastolic Blood Pressure||from baseline to 24 hours following drug administration|||mmHg||Standard Deviation|Mean
661191|NCT01844830|Secondary|Maximum Change From Baseline in Systolic Blood Pressure||from baseline to 24 hours following drug administration|||mmHg||Standard Deviation|Mean
661192|NCT01844830|Secondary|Maximum Change From Baseline in Heart Rate||from baseline to 24 hours following drug administration|||bpm||Standard Deviation|Mean
661193|NCT01844830|Secondary|Results of Naris Examination (NE) - Patency and Ulcerations|"The investigators evaluated the treatment naris for patency and ulcerations.
Patency was evaluated as followed: The nostril not used for dosing study drug was manually occluded and the subject was asked to sniff gently. Airflow in the naris was used to determine if it was patent (yes) or not (no).
For ulcers, the investigators performed a visual examination for the presence of ulcers and recorded if they were present (yes) or not (no)."|120 minutes post drug administration|||Participants|||Count of Participants
661194|NCT01844830|Secondary|Incidence of Adverse Events (AEs) by Age Group|Patients with AEs|from baseline to 24 hours following drug administration|Patients group by age||Count of participants|||Number
661195|NCT01844830|Secondary|Incidence of Adverse Events (AEs) by Dosage Cohort|Patients with AEs|from baseline to 24 hours following drug administration|Patients grouped by dosage cohort||Count of participants|||Number
661196|NCT01844830|Secondary|Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic. by Age Group (3-5, 6-11, and 12-17 Years Old, Inclusive).|If the participant does not have sufficient anesthesia to complete the Study Dental Procedure, the participant is given a rescue injection of local anesthetic and is considered a failure for this outcome.|100µL dose - at 10 minutes, +3 minute window; for subjects who receive the 200µL or 400µL dose - at 15 minutes, +3 minute window|Patients are grouped by age||Participants|||Count of Participants
661217|NCT01844687|Primary|Mood Scale - Subscale 'Feeling High'|Visual analog scale range 1 (not at all) - 100 (extremely) millimeters.|two hours before and after marijuana cigarette smoking|all 31 completers||units on a scale VAS 1-100 mm||Standard Error|Mean
666031|NCT01763905|Secondary|Percent Change From Baseline in Very Low-Density Lipoprotein Cholesterol at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
661197|NCT01844830|Secondary|Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic.by Dosage Cohort.|If the participant does not have sufficient anesthesia to complete the Study Dental Procedure, the participant is given a rescue injection of local anesthetic and is considered a failure for this outcome.|100µL dose - at 10 minutes, +3 minute window; for subjects who receive the 200µL or 400µL dose - at 15 minutes, +3 minute window|Subjects were in only 1 of 3 dosage cohort. Either 100 µL, 200 µL, or 400 µL.||Participants|||Count of Participants
661198|NCT01844830|Primary|Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic.|If the participant does not have sufficient anesthesia to complete the Study Dental Procedure, the participant is given a rescue injection of local anesthetic and is considered a failure for this outcome.|100µL dose - at 10 minutes, +3 minute window; for subjects who receive the 200µL or 400µL dose - at 15 minutes, +3 minute window|||Participants|||Count of Participants
661199|NCT01844817|Secondary|Objective Response Rate|Objective response rate defined as the percent of patients having a complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR=complete disappearance of all target lesions. PR=decrease in baseline of 30% or more of the diameter(s) of all target lesions.|Every 8 weeks for up to 2 years|Includes Intent-to-Treat Population: all subjects enrolled and randomized||percentage of participants|||Number
661200|NCT01844817|Secondary|Progression-Free Survival|The time (in months) that patients are progression-free, assessed from date of randomization to date of first documented disease progression or date of death from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest (nadir) sum while on study (this includes the baseline sum if that is the smallest on study), or the appearance of one or more new lesions.|Every 8 weeks up to 2 years|Intent-to-Treat Population: all subjects enrolled and randomized||months||95% Confidence Interval|Median
661201|NCT01844817|Primary|Overall Survival|Overall survival defined as the time, in months, from date of randomization until date of death or date last known alive whichever comes first, assessed up to 2 years.|Up to 2 years|Includes Intent-to-Treat Population: all subjects enrolled and randomized||months||95% Confidence Interval|Median
661202|NCT01844778|Secondary|Number of Participants With Post-inhalation Bronchospasm|Bronchospasm was defined as the relative decrease of 20% or more in forced expiratory volume in 1 second (FEV1) percent predicted from pre-dose to 15 to 45 minutes post-dose.|days 1, 28, 57, 84|The FAS was considered for the analysis and included participants who had at least one dose of study treatment. Only participants (n), with values on a given day, were analyzed for that day.||Participants|||Number
661203|NCT01844778|Secondary|Minimum Inhibitory Concentration (MIC) - MIC50 and MIC90 Tobramycin Values|MIC50/90 is the lowest concentration required to inhibit 50%/90% of the isolates tested. The MIC50/90 of a range of antibiotics for P.aeruginosa was determined at the start and end of each treatment cycle, and at the end of the off-treatment period of the second cycle.|days 1, 28, 57, 84, 112|The FAS was considered for the analysis and included participants who had at least one dose of study treatment. Only participants (n), with values on a given day, were analyzed for that day. The number of isolates tested = m.||ug/mL|||Number
661204|NCT01844778|Secondary|Number of Participants With Any Contaminated Delivery Device|Devices used to administer the drugs (the T-326 inhaler and nebulisers) were swabbed for contamination testing at the start and end of each treatment cycle (or discontinuation visit if the participant withdrew). No assessments were required from the T-326 inhaler when participants started the treatment period (days 1 and 57). Microbial contamination was measured according to device type and the frequency of organism growth (light/ moderate/ heavy). All nebulisers (neb) used by the participants were analyzed, including those for inhaling other medications, like mucolytics.|days (d) 1, 28, 57, 84|The FAS was considered for the analysis and included participants who had at least one dose of study treatment. Only participants (n), with an available culture from the delivery device, were analyzed.||Participants|||Number
661205|NCT01844778|Secondary|Change in P. Aeruginosa Sputum Density|Sputum samples were sent to a central laboratory at the start and end of 2 treatment periods. The absolute change in the number of colony forming units (CFU) of Pseudomonas aeruginosa in sputum = the value of end of on/off treatment period of the cycle minus the pre-dose value at the start of that cycle. A negative change from baseline indicates improvement.|days 1, 28 (cycle 1); 57, 84, 112 (cycle 2)|"The FAS was considered and included participants who received at least 1 dose of treatment. Only participants (n), with values at the start and end of an on-treatment period (on-treatment change), and/or with values at the start of an on-treatment period and end of an off-treatment period (off-treatment change), were analyzed."||log10 CFU/mL||Standard Deviation|Mean
661206|NCT01844778|Primary|Mean Total Administration Time|The mean total time for administration of TIP via T-326 inhaler versus the total time for administration of COLI or TIS was assessed from information entered by participants into an ediary during the last 7 days prior to the last dose of a cycle. The total time included the setup, preparation, administration and cleaning/disinfection time.|days 22 through 28 (cycle 1), days 78 through 84 (cycle 2)|The full analysis set (FAS) was considered for this analysis. The FAS included participants who received at least 1 dose of treatment. Only participants (n), with non-missing mean total administration time of initial and second cycles, were analyzed.||minutes||Standard Deviation|Mean
661207|NCT01844700|Secondary|BMI Percentile||baseline to week 12|||BMI percentile||Standard Deviation|Mean
661208|NCT01844700|Secondary|BMI Z-scores||baseline to week 12|||BMI z-score||Standard Deviation|Mean
661209|NCT01844700|Secondary|Percent Weight Change Compared to Baseline Weight||baseline to week 12|||percentage of weight change||Standard Deviation|Mean
661210|NCT01844700|Primary|Weight Change||baseline to week 12|||lbs||Standard Deviation|Mean
661211|NCT01844687|Other Pre-specified|Plasma Concentration of CBD|Plasma concentrations of cannabidiol were measured at six time points after oral administration of four 200 mg capsules of CBD.|6 hours|8 participants volunteered to come to a ninth session for dosing with 800 mg CBD and donation of 7 blood samples.||ng/mL||Standard Error|Mean
661212|NCT01844687|Other Pre-specified|Heart Rate|Heart rate measured at 10 time points, 4 before and 6 after smoking cannabis.|120 minutes before and 150 minutes after marijuana cigarette smoking|all study completers||beats per minute||Standard Error|Mean
661218|NCT01844531|Secondary|AUC0-tz for Metformin|AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) for Metformin|1hour (h) before drug intake and 20minutes (min),40min,1h,1h 30min,2h,2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h,10h,12h,24h,34h,48h,72h after drug intake|Pharmacokinetics set (PKS) included all treated subjects with at least 1 evaluable observation for at least 1 primary pharmacokinetic endpoint without important protocol violations relevant to the statistical evaluation of pharmacokinetics who had not taken any restricted medication and had not experienced emesis before or at 2 times median tmax||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
661219|NCT01844531|Primary|Cmax for Metformin|Cmax (maximum measured concentration of the analyte in plasma) for Metformin|1hour (h) before drug intake and 20minutes (min),40min,1h,1h 30min,2h,2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h,10h,12h,24h,34h,48h,72h after drug intake|Pharmacokinetics set (PKS) included all treated subjects with at least 1 evaluable observation for at least 1 primary pharmacokinetic endpoint without important protocol violations relevant to the statistical evaluation of pharmacokinetics who had not taken any restricted medication and had not experienced emesis before or at 2 times median tmax||ng/mL||Geometric Coefficient of Variation|Geometric Mean
661220|NCT01844531|Primary|Cmax for Empagliflozin|Cmax (maximum measured concentration of the analyte in plasma) for Empagliflozin|1hour (h) before drug intake and 20minutes (min),40min,1h,1h 30min,2h,2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h,10h,12h,24h,34h,48h,72h after drug intake|Pharmacokinetics set (PKS) included all treated subjects with at least 1 evaluable observation for at least 1 primary pharmacokinetic endpoint without important protocol violations relevant to the statistical evaluation of pharmacokinetics who had not taken any restricted medication and had not experienced emesis before or at 2 times median tmax||nmol/L||Geometric Coefficient of Variation|Geometric Mean
661221|NCT01844531|Secondary|AUC0-tz for Empagliflozin|AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) for Empagliflozin|1hour (h) before drug intake and 20minutes (min),40min,1h,1h 30min,2h,2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h,10h,12h,24h,34h,48h,72h after drug intake|Pharmacokinetics set (PKS) included all treated subjects with at least 1 evaluable observation for at least 1 primary pharmacokinetic endpoint without important protocol violations relevant to the statistical evaluation of pharmacokinetics who had not taken any restricted medication and had not experienced emesis before or at 2 times median tmax||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
661222|NCT01844531|Primary|AUC0−∞ for Metformin|AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) for Metformin|1hour (h) before drug intake and 20minutes (min),40min,1h,1h 30min,2h,2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h,10h,12h,24h,34h,48h,72h after drug intake|Pharmacokinetics set (PKS) included all treated subjects with at least 1 evaluable observation for at least 1 primary pharmacokinetic endpoint without important protocol violations relevant to the statistical evaluation of pharmacokinetics who had not taken any restricted medication and had not experienced emesis before or at 2 times median tmax||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
661223|NCT01844531|Primary|AUC0−∞ for Empagliflozin|AUC0−∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) for Empagliflozin|1hour (h) before drug intake and 20minutes (min),40min,1h,1h 30min,2h,2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h,10h,12h,24h,34h,48h,72h after drug intake|Pharmacokinetics set (PKS) included all treated subjects with at least 1 evaluable observation for at least 1 primary pharmacokinetic endpoint without important protocol violations relevant to the statistical evaluation of pharmacokinetics who had not taken any restricted medication and had not experienced emesis before or at 2 times median tmax||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
661224|NCT01844518|Secondary|Number of Participants (Ages 6 to 17) With Positive Immunogenicity Response in the Cumulative Period|Overall number of participants with either a positive immunogenicity response for ‘CTLA4 and possibly Ig’ or ‘Ig and/or Junction Region’ relative to baseline. Sample draws for immunogenicity were scheduled at specific study days while on treatment for all subjects and at follow-up visits 28, 85, and 168 days after the last abatacept dose regardless of whether they discontinued early in the ST or LTE period, elected not to enter the LTE period, or completed both ST and LTE periods.|Day 1 to 6 months following discontinuation of treatment, up to March 2015|All participants, ages 6 to 17, who received at least one dose of study medication and who had at least one immunogenicity result reported after start of study medication||participants|||Number
661225|NCT01844518|Secondary|Number of Participants (Ages 6 to 17) With Positive Immunogenicity Response in the Short Term Period|Overall number of participants with either a positive immunogenicity response for ‘CTLA4 and possibly Ig’ or ‘Ig and/or Junction Region’ relative to baseline. Sample draws for immunogenicity were scheduled at specific study days while on treatment for all subjects and at follow-up visits 28, 85, and 168 days after the last abatacept dose for those subjects who discontinued from the ST period or completed the ST study without continuing abatacept treatment.|Day 1 to 168 days after the last dose of study medication in the short-term period|All participants, ages 6 to 17, who received at least one dose of study medication and who had at least one immunogenicity result reported after start of study medication||participants|||Number
661226|NCT01844518|Secondary|Number of Participants (Ages 6 to 17) With Adverse Events (AEs) of Special Interest in the Cumulative Period|"AE=any new unfavorable symptom, sign or disease or worsening of a preexisting condition that may not have a causal relationship with treatment.
AEs of special interest include infections, autoimmune disorders, malignancies, local injection site reactions and AEs within 24 hours of study drug administration.
The select AEs were determined using the Medical Dictionary for Regulatory Activities (MedDRA, v15.1) and graded using the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0."|Day 1 up to 56 days after last dose, up to March 2015|All treated participants, ages 6 to 17||participants|||Number
661260|NCT01844388|Other Pre-specified|Reason for Contact Lens Replacement|The reason the contact lens needed to be replaced was recorded for each eye. The following categories are reported: Scheduled Replacement, Discomfort, Lens Damage, Unacceptable Vision and Lens Lost. There may be multiple reasons for replacement of the contact lens for a single eye.|Day 90|Completed population included all enrolled participants who received study treatment and completed the study through Day 90.||eyes|Participants||Number
666032|NCT01763905|Secondary|Percent Change From Baseline in Very Low-Density Lipoprotein Cholesterol at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
661227|NCT01844518|Secondary|Number of Participants (Ages 6 to 17) With Adverse Events (AEs), Deaths, Serious AEs and AEs Leading to Discontinuation in the Cumulative Period|"AE=any new unfavorable symptom, sign or disease or worsening of a preexisting condition that may not have a causal relationship with treatment.
SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity or drug dependency/abuse; is life-threatening, an important medical event or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible or missing relationship to study drug. Death=during the study and up to 28 days past study discontinuation. The select AEs were determined using the Medical Dictionary for Regulatory Activities (MedDRA, v15.1) and graded using the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0."|Day 1 up to 56 days after last dose up to March 2015|All treated participants, ages 6 to 17||participants|||Number
661228|NCT01844518|Secondary|Number of Participants (Ages 6 to 17) With Adverse Events (AEs) of Special Interest in the Short Term Period|"AE=any new unfavorable symptom, sign or disease or worsening of a preexisting condition that may not have a causal relationship with treatment.
AEs of special interest include infections, autoimmune disorders, malignancies, local injection site reactions and AEs within 24 hours of study drug administration.
The select AEs were determined using the Medical Dictionary for Regulatory Activities (MedDRA, v15.1) and graded using the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0."|Day 1 up to 56 days after last dose up to March 2015|All treated participants, ages 6 to 17||participants|||Number
661229|NCT01844518|Secondary|Number of Participants (Ages 6 to 17) With Adverse Events (AEs), Deaths, Serious AEs (SAEs) and AEs Leading to Discontinuation in the Short Term Period|"AE=any new unfavorable symptom, sign or disease or worsening of a preexisting condition that may not have a causal relationship with treatment.
SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity or drug dependency/abuse; is life-threatening, an important medical event or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible or missing relationship to study drug. Death=during the study and up to 28 days past study discontinuation. The select AEs were determined using the Medical Dictionary for Regulatory Activities (MedDRA, v15.1) and graded using the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0."|Day 1 up to 56 days after last dose up to March 2015|All treated participants, ages 6 to 17||participants|||Number
661230|NCT01844518|Secondary|Abatacept Trough Concentration (Cmin) in Participants Ages 6 to 17|Evaluation of the trough concentration of abatacept (reported as geometric mean of Cmin) in all pk-evaluable participants at Days 57, 85 and 113 during a 4-month treatment period. Weight-tiered dosing groups are based on the first dose the participant received. Cmin is reported in microgram per milliliter (µg/mL).|Days 57, 85 and 113|All treated participants, ages 6 to 17, with PK-evaluable concentration data||microgram per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
661231|NCT01844518|Secondary|Percentage of Participants (Ages 6 to 17) Achieving American College of Rheumatology Pediatric 30 Response (ACRp30)|ACRp30 is defined as ≥30% improvement in at least 3 of the 6 juvenile idiopathic arthritis (JIA) core set variables [number of active joints, number of joints with limitation of motion (LOM), physician global assessment of disease activity, parent global assessment of patient overall well-being, functional ability as measured by the Children's Health Assessment Questionnaire (CHAQ) and C-reactive protein (CRP)] and ≥30% worsening in not more than 1 of the remaining 6 JIA core set variables.|Day 113|All participants, ages 6 to 17||percentage of participants||95% Confidence Interval|Number
661232|NCT01844518|Primary|Abatacept Trough Concentration (Cmin) in Participants Ages 6 to 17|Trough concentration of abatacept (reported as geometric mean of Cmin) in all pharmacokinetic (PK)-evaluable participants. Cmin is reported in microgram per milliliter (µg/mL). Desired target therapeutic Cmin should be >= 10 µg/mL.|Day 113|All treated participants, ages 6 to 17, with evaluable PK concentration data||µg/mL||Geometric Coefficient of Variation|Geometric Mean
661233|NCT01844505|Secondary|Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning|Health Related Quality of Life was assessed using the EORTC QLQ-C30 questionnaire Version 3. With the exception of 2 items included in the global health/quality of life scale, for which responses range from 1 (Very poor) to 7 (Excellent), item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores for all functional scales and Global Health Status indicate better HRQoL; an increase from baseline indicates improvement in HRQoL compared to baseline.|Baseline and weeks 5, 7, 11, 13, 17, 19, 23, 25, then every 6 weeks until treatment discontinuation|All randomized participants with evaluable EORTC scores at baseline and specified time point||Points on EORTC scale||Standard Deviation|Mean
661234|NCT01844505|Secondary|Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning|Health Related Quality of Life was assessed using the EORTC QLQ-C30 questionnaire Version 3. With the exception of 2 items included in the global health/quality of life scale, for which responses range from 1 (Very poor) to 7 (Excellent), item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores for all functional scales and Global Health Status indicate better HRQoL; an increase from baseline indicates improvement in HRQoL compared to baseline.|Baseline and weeks 5, 7, 11, 13, 17, 19, 23, 25, then every 6 weeks until treatment discontinuation|All randomized participants with evaluable EORTC scores at baseline and specified time point||Points on EORTC scale||Standard Deviation|Mean
661235|NCT01844505|Secondary|Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning|Health Related Quality of Life was assessed using the EORTC QLQ-C30 questionnaire Version 3. With the exception of 2 items included in the global health/quality of life scale, for which responses range from 1 (Very poor) to 7 (Excellent), item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores for all functional scales and Global Health Status indicate better HRQoL; an increase from baseline indicates improvement in HRQoL compared to baseline.|Baseline and weeks 5, 7, 11, 13, 17, 19, 23, 25, then every 6 weeks until treatment discontinuation|All randomized participants with evaluable EORTC scores at baseline and specified time point||Points on EORTC scale||Standard Deviation|Mean
661236|NCT01844505|Secondary|Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning|Health Related Quality of Life was assessed using the EORTC QLQ-C30 questionnaire Version 3. With the exception of 2 items included in the global health/quality of life scale, for which responses range from 1 (Very poor) to 7 (Excellent), item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores for all functional scales and Global Health Status indicate better HRQoL; an increase from baseline indicates improvement in HRQoL compared to baseline.|Baseline and weeks 5, 7, 11, 13, 17, 19, 23, 25, then every 6 weeks until treatment discontinuation|All randomized participants with evaluable EORTC scores at baseline and specified time point||Points on EORTC scale||Standard Deviation|Mean
661237|NCT01844505|Secondary|Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning|Health Related Quality of Life was assessed using the EORTC QLQ-C30 questionnaire Version 3. With the exception of 2 items included in the global health/quality of life scale, for which responses range from 1 (Very poor) to 7 (Excellent), item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores for all functional scales and Global Health Status indicate better HRQoL; an increase from baseline indicates improvement in HRQoL compared to baseline.|Baseline and weeks 5, 7, 11, 13, 17, 19, 23, 25, then every 6 weeks until treatment discontinuation|All randomized participants with evaluable EORTC scores at baseline and specified time point||Points on EORTC scale||Standard Deviation|Mean
661238|NCT01844505|Secondary|Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status|Health Related Quality of Life was assessed using the EORTC QLQ-C30 questionnaire Version 3. With the exception of 2 items included in the global health/quality of life scale, for which responses range from 1 (Very poor) to 7 (Excellent), item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores for all functional scales and Global Health Status indicate better HRQoL; an increase from baseline indicates improvement in HRQoL compared to baseline. The mean score for all participants in an arm at a given week was subtracted from the mean score of the participants in that arm at baseline. Mean changes from baseline score is presented for all participants in an arm that remained on treatment and completed the EORTC-QLQ-C30 questionnaire at that time point.|Baseline and weeks 5, 7, 11, 13, 17, 19, 23, 25, then every 6 weeks until treatment discontinuation|All randomized participants with evaluable EORTC scores at baseline and specified time point||Points on EORTC scale||Standard Deviation|Mean
661239|NCT01844505|Secondary|Overall Survival Based on PD-L1 Expression Level|OS was defined as the time between the date of randomization and the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.|From randomization until date of death (Assessed up to September 2016, approximately 39 months)|All randomized participants with evaluable PD-L1 expression level at baseline||months||95% Confidence Interval|Median
661240|NCT01844505|Secondary|Progression-Free Survival Based on PD-L1 Expression Level|PD-L1 expression was defined as the percent of tumor cells demonstrating plasma membrane PD-L1 staining of any intensity using an IHC assay. Tumor biopsy specimens without measurable PD-L1 expression were classified as indeterminate if the staining was hampered for reasons attributed to the biology of the specimen and not because of improper specimen preparation or handling. Missing specimens, specimens that were not optimally collected (ie not evaluable), and all other specimens were classified as unknown. Participants must have been classified as PD-L1 >=5% or PD-L1 <5% per a verified IHC assay, or as indeterminate (ie not unknown), in order to be randomized.|From randomization until disease progression or death from any cause, whichever occurs first (Assessed up to September 2016, approximately 39 months)|All randomized participants with evaluable PD-L1 expression level at baseline||months||95% Confidence Interval|Median
661241|NCT01844505|Secondary|Objective Response Rate (ORR) Per Investigator Assessment|The ORR was defined as the number of participants with a best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of randomized participants for each arm. The BOR was defined as the best response designation, as determined by the Investigator, recorded between the date of randomization and the date of progression, as assessed by the Investigator per RECIST 1.1 or the date of subsequent anticancer therapy (including tumor-directed radiotherapy and tumor-directed surgery), whichever occurred first. For participants without evidence of RECIST 1.1 progression or subsequent anticancer therapy, all available response designations contributed to the BOR assessment. CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measureable disease and no new sites; Stable Disease (SD)= Failure to attain CR/PR or PD; Progressive Disease (PD)= Any new lesion or increase by >=50% of previously involved sites from nadir.|From randomization until date of disease progression or the date of subsequent anti-cancer therapy, whichever occurs first (Assessed up to February 2015, approximately 20 months)|All randomized participants||Percentage of participants||95% Confidence Interval|Number
661242|NCT01844505|Secondary|Overall Survival (OS)|OS data is presented as it was in Primary Outcome Measure #2. The statistical analysis following this outcome measure (#6) reports on a secondary objective comparing OS between the Nivolumab and Nivolumab + Ipilimumab arms.|From randomization to date of death (Assessed up to September 2016, approximately 39 months)|All randomized participants||months||95% Confidence Interval|Median
661243|NCT01844505|Secondary|Progression Free Survival (PFS)|PFS data is presented as it was in Primary Outcome Measure #1. The statistical analysis following this outcome measure (#5) reports on a secondary objective comparing PFS between the Nivolumab and Nivolumab + Ipilimumab arms.|From randomization until disease progression or death, whichever occurred first (assessed up to February 2015, approximately 20 months)|All randomized participants||months||95% Confidence Interval|Median
661261|NCT01844388|Other Pre-specified|Average Daily Contact Wearing Time|The average reported number of hours per day that contact lenses were worn by participants during the previous 7 days.|Day 90|Completed population included all enrolled participants who received study treatment and completed the study through Day 90.||hours per day||Standard Deviation|Mean
661328|NCT01842906|Primary|Incidence of Acute Mountain Sickness|Acute mountain sickness will be measured by Lake Louise Criteria and diagnosed as LLC > or = to 3 with presence of a headache. Study participants will be followed approximately for 10 hours, from when they go to sleep until awakening the next morning.|Approximately 10 hours|||Participants|||Count of Participants
661244|NCT01844505|Primary|Rate of Progression-Free Survival|PFS was defined as the time between the date of randomization and the first date of documented progression, as determined by the Investigator, or death due to any cause, whichever occurred first. Participants who died without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who did not have any on study tumor assessments and did not die were censored on their date of randomization. Participants treated beyond progression were considered to have progressive disease at the time of the initial progression event regardless of subsequent tumor response. Participants who started anti-cancer therapy without a prior reported progression were censored on the date of their last evaluable tumor assessment prior to the initiation of subsequent anti-cancer therapy.|6, 12, and 24 months|All randomized participants||Percentage of participants||95% Confidence Interval|Number
661245|NCT01844505|Primary|Rate of Overall Survival|OS was defined as the time between the date of randomization and the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive. The overall survival rate at time T (6, 12, or 24 months) was defined as the probability that a participant was alive at time T following randomization.|6, 12, and 24 months|All randomized participants||Probability of survival at Time T||95% Confidence Interval|Number
661246|NCT01844505|Primary|Overall Survival (OS)|OS was defined as the time between the date of randomization and the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.|From randomization to date of death (Assessed up to September 2016, approximately 39 months)|All randomized participants||months||95% Confidence Interval|Median
661247|NCT01844505|Primary|Progression Free Survival (PFS)|PFS was defined as the time between the date of randomization and the first date of documented progression, as determined by the Investigator, or death due to any cause, whichever occurred first. Progression is defined, using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, and an absolute increase of at least 5 mm. Participants who died without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who did not have any on study tumor assessments and did not die were censored on their date of randomization. Participants who started anti-cancer therapy without prior reported progression were censored on the date of their last evaluable tumor assessment prior to the initiation of subsequent anti-cancer therapy.|From randomization until disease progression or death, whichever occurred first (assessed up to February 2015, approximately 20 months)|All randomized participants||months||95% Confidence Interval|Median
661248|NCT01844479|Secondary|Gait Speed Variability Dual Task|Gait speed variability (estimated using coefficient and variation of stride velocity) Dual task used a simultaneous mental task while walking.|Both footwear conditions up to thirty minutes|||percentage of gait||Standard Deviation|Mean
661249|NCT01844479|Secondary|Gait Speed Variability Single Task|Gait speed variability (estimated using coefficient and variation of stride velocity) Single task means walking without a simultaneous mental task.|both footwear conditions up to 30 minutes|||percentage of gait||Standard Deviation|Mean
661250|NCT01844479|Secondary|Medial and Lateral Center of Mass Displacement Dual Task|Mediolateral (side-to-side) center of mass displacement in deg2 (degrees squared) under dual task gait. Dual task used a simultaneous mental task while walking.|both footwear conditions up to 30 minutes|||deg2||Standard Deviation|Mean
661251|NCT01844479|Secondary|Medial and Lateral Center of Mass Displacement Single Task|Mediolateral (side-to-side) center of mass displacement with displacement in deg2 (degrees squared) under single task gait conditions. Single task means walking without a simultaneous mental task.|under each foot where condition up to 30 minutes|||deg2||Standard Deviation|Mean
661252|NCT01844479|Secondary|Double Support Time Dual Task Gait Initiation|percentage of stride time spent in double support time during dual task conditions and during gait initiation. Double support time refers to the time spent with both feet on the ground. Dual task used a simultaneous mental task while walking.|during each foot where condition up to 30 minutes|||percentage of stride time||Standard Deviation|Mean
661253|NCT01844479|Secondary|Double Support Time Single Task|percentage of stride time spent in double support time during gait initiation. Double support time refers to the time spent with both feet on the ground. Single task means walking without a simultaneous mental task.|during each foot where condition up to 30 minutes|||percentage of stride time||Standard Deviation|Mean
661254|NCT01844479|Secondary|Stride Velocity - Dual Task|Stride velocity during steady state dual task. Dual task used a simultaneous mental task while walking.|during each foot wear condition up to 30 minutes|||m/s||Standard Deviation|Mean
661255|NCT01844479|Secondary|Gait Initiation - Dual Task|The number of steps taken to reach steady state walking under dual task. Dual task used a simultaneous mental task while walking.|during each foot wear condition up to 30 minutes|||Number of steps||Standard Deviation|Mean
661256|NCT01844479|Other Pre-specified|Sudomotor Function|Sudomotor function will be measured by electrical sweat conductance (ESC), as expressed in microSiemens (µS).|at baseline, this is a single visit study expected to last one hour|||µS||Standard Deviation|Mean
661257|NCT01844479|Other Pre-specified|Stride Velocity - Single Task|Stride velocity steady state gait single task. Single task means walking without a simultaneous mental task.|during each foot wear condition up to 30 minutes|||meters/second||Standard Deviation|Mean
661258|NCT01844479|Secondary|Gait Initation - Single Task|The number of steps taken to reach steady state walking under single task. Single task means walking without a simultaneous mental task.|during each foot wear condition up to 30 minutes|||Number of steps||Standard Deviation|Mean
661259|NCT01844479|Primary|Plantar Foot Temperature Changes in Regions-of-interest in Response to Walking|Plantar foot temperature changes in regions-of-interest in response to walking 200 steps will be measured in each footwear condition and compared to baseline.|baseline and after 200 steps in each condition, this is a single visit study expected to last one hour|||Absolute change in temperature degrees||Standard Deviation|Mean
661329|NCT01842841|Secondary|Change From Baseline in Chemokine [C-C Motif] Ligand 18 (CCL18) Levels at Week 101|Plasma CCL18 concentrations were measured using a time-resolved fluorescence assay. Week 51 of Study HGT-GCB-087 (NCT01614574) was considered as baseline for this endpoint.|Baseline, Week 101|Safety population||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
661262|NCT01844388|Primary|Percentage of Participants With Contact Lens Distance Visual Acuity Change From Baseline|Contact lens distance visual acuity was measured for each eye using the LogMAR visual acuity eye chart. The worse eye at Baseline was used for analysis. A change of 0.1 on the LogMAR scale was equivalent to a 1 line change in visual acuity. The following categories are reported: Better=an increase in 2 or more lines, No Change=a change of +/- 1 line, and Worse=a decrease of 2 lines or more.|Baseline, Day 90|Intent-to-treat Population included all randomized participants.||percentage of participants|||Number
661263|NCT01844206|Primary|The Average Amount of Intravenous Morphine Patients Self-administered in the Second 24 Hours Post-surgery|The primary outcome of this study is the amount (mg) of morphine self-administered by PCA pump during the second 24 hours after surgery. This will be compared by unpaired t-test for two groups.|Up to 48 hours post-operatively|"Data could not be summarized to include in the data table because only 5 out of 140 subjects were enrolled prior to study termination, and no data analysis was carried out. As instructed, we are specifying zero (0) for the Number of Participants Analyzed in each Arm/Group and leaving the data fields blank."|||||
661264|NCT01843972|Primary|Frequency of Subjects With Drug-related Adverse Events (Part I)|Frequency of subjects with drug-related Adverse Events (AEs) (Part I)|Part I: 'Day1 to Day21 for Dose 1, 2,3 &4 and Day1 to Day45 for Dose group 5,6 & 7|Treated Set (TS): all subjects who were documented to have taken at least 1 dose of study medication.||Participants|||Number
661265|NCT01843972|Secondary|Tmax (Part I)|"tmax (time from dosing to maximum measured concentration of BI 691751) (part I)
Time frame:
Dose 1 and 2: 1 hour (h) before drug administration (admin) and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h and 168h after drug admin
Dose 3 and 4: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h (dose group 4 only), 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h and 240h after drug admin
Dose 5 to 7: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 336h, 432h, 528h, 624h and 720h after drug admin
Dose 8: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h, 144h, 216h, 384h, 552h and 720h after drug admin"|for dose 1 & 2: up to 168 hours (h), for dose 3 & 4: up to 240h, for dose 5 to 8: up to 720h|PKS||h||Full Range|Median
661266|NCT01843972|Secondary|t1/2 (Part I)|"t1/2 (terminal half-life of the analyte of BI 691751 in plasma) (part I)
Time frame:
Dose 1 and 2: 1 hour (h) before drug administration (admin) and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h and 168h after drug admin
Dose 3 and 4: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h (dose group 4 only), 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h and 240h after drug admin
Dose 5 to 7: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 336h, 432h, 528h, 624h and 720h after drug admin
Dose 8: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h, 144h, 216h, 384h, 552h and 720h after drug admin"|for dose 1 & 2: up to 168 hours (h), for dose 3 & 4: up to 240h, for dose 5 to 8: up to 720h|Pharmacokinetic (PK) set (PKS) which includes all subjects of the treated set were were randomised to active treatment in the single rising dose part of bioavailability part, and had no important protocol violations relevant for the statistical evaluation of further PK parameters. Only subjects with calculable PK parameter were analysed.||h||Geometric Coefficient of Variation|Geometric Mean
661267|NCT01843972|Secondary|AUC0-tz|"AUC0-tz (area under the concentration-time curve of BI 691751 in plasma over the time interval from 0 up to the last quantifiable data point) (Part I and Part II)
Time frame:
Dose 1 and 2: 1 hour (h) before drug administration (admin) and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h and 168h after drug admin
Dose 3 and 4: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h (dose group 4 only), 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h and 240h after drug admin
Dose 5 to 7: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 336h, 432h, 528h, 624h and 720h after drug admin
Dose 8: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h, 144h, 216h, 384h, 552h and 720h after drug admin"|Part 1: for dose 1 & 2: up to 168 hours (h), for dose 3 & 4: up to 240h, for dose 5 to 7: up to 720h; Part 2: up to 720h|PPS-DP for part I and PPS-BA for part II. Only subjects with calculable PK parameter were analysed.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
661268|NCT01843972|Secondary|AUC0-infinity (Part I)|"AUC0-infinity (area under the concentration-time curve of BI 691751 in plasma over the time interval from 0 extrapolated to infinity) (part I)
Time frame:
Dose 1 and 2: 1 hour (h) before drug administration (admin) and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h and 168h after drug admin
Dose 3 and 4: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h (dose group 4 only), 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h and 240h after drug admin
Dose 5 to 7: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 336h, 432h, 528h, 624h and 720h after drug admin
Dose 8: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h, 144h, 216h, 384h, 552h and 720h after drug admin"|for dose 1 & 2: up to 168 hours (h), for dose 3 & 4: up to 240h, for dose 5 to 8: up to 720h|PPS-DP. Only subjects with calculable PK parameter were analysed.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
661295|NCT01843465|Primary|Real-time Documentation of Pulmonary Vein Disconnection|"Possibility of real-time documentation of the pulmonary vein during cryoballoon ablation, through the use of the Achieve catheter. This will be codified as yes or no, and in case of an affirmative answer Final results will be expressed as a % of the total pulmonary veins where disconnection was documented in real-time and the time of maneuver of the Achieve catheter that was necessary i.e. standard position (type 1); withdrawal position (type 2) or need of pacing (type 3). A pulmonary vein where no real-time documentation is possible, will be named as a type 4."|atrial fibrillation cryoablation procedure|According to the different pulmonary vein anatomies in the study sample, 128 pulmonary veins were assessed.||number of PVs disconnected in realtime|Participants||Number
661296|NCT01843374|Secondary|Number of Participants With Positive Anti-drug Antibodies|The immunogenicity titer is reported for samples confirmed positive for the presence of anti tremelimumab antibodies.|Week 5|Safety population||Participants|Participants||Number
661269|NCT01843972|Secondary|Cmax (Part I)|"Cmax (maximum measured concentration of BI 691751 in plasma) (part I)
Time frame:
Dose 1 and 2: 1 hour (h) before drug administration (admin) and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h and 168h after drug admin
Dose 3 and 4: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h (dose group 4 only), 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h and 240h after drug admin
Dose 5 to 7: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 336h, 432h, 528h, 624h and 720h after drug admin
Dose 8: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h, 144h, 216h, 384h, 552h and 720h after drug admin"|for dose 1 & 2: up to 168h, for dose 3 & 4: up to 240h, for dose 5 to 8: up to 720h|Per protocol set for evaluation of dose proportionality (PPS-DP): This subject set includes all subjects of the TS who were randomised to active treatment in the single rising dose part or BA part, and had no important PVs relevant for the statistical evaluation of dose proportionality. Only subjects with calculable PK parameter were analysed.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
661270|NCT01843972|Primary|Cmax (Part II)|Cmax (maximum measured concentration of the analyte of BI 691751 in plasma) (part II)|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 144h, 216h, 384h, 552h and 720h after drug administration|PPS-BA. Only subjects with calculable PK parameter were analysed.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
661271|NCT01843972|Primary|AUC0-72h (Part II)|"AUC0-72h (area under the concentration-time curve of the analyte of BI 691751 in plasma over the time interval from 0 to 72 h) (part II).
PPS-BA included all subjects in the TS who were randomised to the BA part, who provided at least one observation for at least one primary endpoint, had no important protocol violations relevant for the statistical evaluation of BA and did not experience emesis at or before twice the median tmax."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h and 72h after drug administration|Per protocol set for evaluation of bioavailability (PPS-BA). Only subjects with calculable PK parameter were analysed.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
661272|NCT01843933|Primary|Abnormal ETCO2 Values, Abnormal Pulse Oximetry Values, and Staff Interventions|"Mild Events/Interventions:
Mild oxygen desaturation: Pulse oximetry < 93% on room air or <95% on oxygen
Hypopneic hypoventilation: ETCO2 values < 30mmHg for >30 seconds
Bradypneic hypoventilation: ETCO2 values > 50mmHg for >30 seconds
Stimulation: Verbally or physical stimulation to encourage breathing
Moderate Events/Interventions:
Moderate oxygen desaturation: Pulse oximetry < 85% on room air or <90% on oxygen
Apnea: ETCO2 value of 0mmHg or respiratory rate of 0 for >20 seconds
Airway obstruction: ETCO2 value of 0mmHg without cessation of respiratory effort
Airway repositioning: Jaw thrust or chin lift or use of a shoulder roll
Airway adjunct: Oral or nasal airway device
Severe Events/Interventions:
Severe oxygen desaturation: Pulse oximetry < 80% on room air or <85% on oxygen
Assisted ventilation: Use of a bag-valve mask, a laryngeal mask airway or endotracheal intubation
Reversal medications: Use of naloxone or flumazenil"|Post operative period (From entering the PACU until discharge. Average time is 1 hour)|||participants|||Number
661273|NCT01843920|Secondary|Return of Intraocular Pressure to Normal Levels|The normal intraocular pressure range is 10-21 mm Hg|Post-op Day 1, Week 1, Month 1, Month 2, Month 4||||||
661274|NCT01843920|Primary|Complete Resolution of Intraocular Gas Bubble|This will be reported by the patient when they see/feel the gas bubble disappear.|Following surgery, until gas bubble is gone. Up to 2 months.|||Duration in days, gas bubble||Full Range|Mean
661275|NCT01843777|Secondary|Difference Between Pre-intervention and Post-intervention Total Score on International Outcome Inventory for Hearing Aids|The total score from the International Outcome Inventory for Hearing Aids (IOI-HA; Cox et al., 2000) was used to assess overall hearing-aid outcome. This measure consists of seven items assessing (1) daily hearing-aid use, (2) benefit, (3) residual activity limitation, (4) satisfaction, (5) residual participation restriction, (6) impact (of hearing impairment) on others, and (7) quality of Life. Responses to each question range from 1 (poorest) to 5 (best), for a total score range from 7 points to 35 points. The reported measurement was the change in total score from pre-intervention to post-intervention, with a maximum possible change of 28 points.|Collected twice once at pre-intervention visit and once at a post-intervention visit occurring four to six weeks following the intervention|In the standard-of-care group, one subject withdrew from the study prior to the collection of outcome measures. In the treatment group, one subject did not answer one of the questions on the baseline questionnaire, thereby preventing calculation of a total score. This subject's data is therefore not included in the analysis.||units on a scale||Standard Deviation|Mean
661276|NCT01843777|Primary|Difference in Hours of Hearing Aid Use Between Pre-intervention and Post-intervention|Hearing aid use was measured by the number of hours of use recorded in the hearing-aid software. This was measured on up to four occasions: Visit #1 to #3 (pre-intervention), and Visit #4 (post-intervention). Average daily hours of hearing aid use was documented at each time point, so that the Visit #4 observation is a measure of the average daily use between the start of intervention (Visit #3) and visit #4. Data logger results were averaged between the left and right hearing aids at each time point and across all three pre-intervention time points.|Collected pre-intervention and again at post-intervention appointment occurring between four and six weeks after the intervention date|"Standard-of-care group: one subject withdrew prior to the collection of outcome measures and one subject did not give valid data log measurement. These subjects are not included.
Treatment: Three subjects did not give valid outcome data log measurement and one did not give a valid baseline measure. These subjects are not included."||hours||Standard Deviation|Mean
661277|NCT01843673|Primary|Greater Than or Equal to 5% Variation of Normal Tissue Toxicity||Up to 7 weeks|No data analyzed due to staff leaving primary institution.|||||
661278|NCT01843673|Primary|Dose Variation Between the Different Imaging Technologies for Normal Tissue Structures of 10%||Up to 7 weeks|No data analyzed due to staff leaving primary institution.|||||
661297|NCT01843374|Secondary|Number of Participants Reporting Any Serious Adverse Events||Day 1 to 90 days post dose|Safety population||Participants|Participants||Number
661298|NCT01843374|Secondary|Number of Participants Reporting Any Adverse Event|Any untoward medical occurrence in a patient or clinical investigation participants administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.|Day 1- 90 days post dose|Safety population||Participants|Participants||Number
661279|NCT01843673|Primary|Differences of Calculated Set up Errors of 2 mm Between the Different Imaging Technologies|The automated patient setup procedure varies between 'OBI', 'CBCT' or 'Exactrac' imaging technologies. Each procedure gives two shifts: 'vertical' and 'lateral'. In the absence of a gold standard, our goal is to compare the shifts recommended by each pair of automated patient setup procedures. Average and Std deviation of vertical and lateral motion from the three systems were computed. P value, 1.00, refers to the test of difference of each system with OBI being more than 2 mm. Pairwise comparison for each direction between each pair of technologies were done using a t test to check if the difference in the recommended shift is more than 2 mm. The reported mean value represents the shift from planned treatment position averaged over all daily treatment setups. A negative mean vertical value indicates the patient was consistently set up posterior to plan; a negative mean lateral value indicates a set up consistently right of plan.|up to 7 weeks|Ten evaluable head and neck patients treated with external beam radiation therapy received 19 to 32 fractions with all three imaging techniques. The mean daily shift of these 19 to 32 fractions were recorded for each technique. Statistical significance is determined based on 5% level of significance.||mm||Standard Deviation|Mean
661280|NCT01843660|Secondary|Number of Participants With Overall Analgesic Satisfaction Score|Participants and physicians separately evaluated their satisfaction with the analgesic effect of the study drug using a 5-point scale (1=very unsatisfied, 2 =unsatisfied, 3=average, 4= satisfied and 5=very satisfied). Number of participants in each category was reported.|Hour 6|Per protocol population included all participants who completed the clinical trial according to the trial protocol.||Participants|||Number
661281|NCT01843660|Secondary|Number of Participants With Analgesic Satisfaction Score|Participants evaluated their satisfaction with the analgesic effect of the study drug using a 4-point scale (4=very good, 3=good, 2=average, 1=poor). Number of participants in each category was reported.|Hour 6|Per protocol population included all participants who completed the clinical trial according to the trial protocol.||Participants|||Number
661282|NCT01843660|Secondary|Number of Participants Who Required Additional Dosage Administration|Number of participants who additionally required a second tablet within 2 hours after the first administration of the investigational drug was reported.|Baseline up to Hour 2|Per protocol population included all participants who completed the clinical trial according to the trial protocol.||Participants|||Number
661283|NCT01843660|Primary|Number of Participants With Pain Relief Score at Hour 6|Pain relief was measured using 6-point Likert Scale (4=complete, 3=significant/comparatively large, 2=moderate, 1=mild/slight, 0=none, -1=exacerbated/heavier).|Hour 6|Per protocol population included all participants who completed the clinical trial according to the trial protocol.||Participants|||Number
661284|NCT01843660|Primary|Number of Participants With Pain Relief Score at Hour 4|Pain relief was measured using 6-point Likert Scale (4=complete, 3=significant/comparatively large, 2=moderate, 1=mild/slight, 0=none, -1=exacerbated/heavier).|Hour 4|Per protocol population included all participants who completed the clinical trial according to the trial protocol.||Participants|||Number
661285|NCT01843660|Primary|Number of Participants With Pain Relief Score at Hour 3|Pain relief was measured using 6-point Likert Scale (4=complete, 3=significant/comparatively large, 2=moderate, 1=mild/slight, 0=none, -1=exacerbated/heavier).|Hour 3|Per protocol population included all participants who completed the clinical trial according to the trial protocol.||Participants|||Number
661286|NCT01843660|Primary|Number of Participants With Pain Relief Score at Hour 2|Pain relief was measured using 6-point Likert Scale (4=complete, 3=significant/comparatively large, 2=moderate, 1=mild/slight, 0=none, -1=exacerbated/heavier).|Hour 2|Per protocol population included all participants who completed the clinical trial according to the trial protocol.||Participants|||Number
661287|NCT01843660|Primary|Number of Participants With Pain Relief Score at Hour 1|Pain relief was measured using 6-point Likert Scale (4=complete, 3=significant/comparatively large, 2=moderate, 1=mild/slight, 0=none, -1=exacerbated/heavier).|Hour 1|Per protocol population included all participants who completed the clinical trial according to the trial protocol.||Participants|||Number
661288|NCT01843660|Primary|Number of Participants With Pain Relief Score at Hour 0.5|Pain relief was measured using 6-point Likert Scale (4=complete, 3=significant/comparatively large, 2=moderate, 1=mild/slight, 0=none, -1=exacerbated/heavier).|Hour 0.5|Per protocol population included all participants who completed the clinical trial according to the trial protocol.||Participants|||Number
661289|NCT01843660|Primary|Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 6|Pain intensity was measured using NRS (0=painless and 10=most severe pain). Score of 1-3 means mild pain; 4-6 means moderate pain and 7-10 means severe pain.|Hour 6|Per protocol population included all participants who completed the clinical trial according to the trial protocol.||Units on a scale||Standard Deviation|Mean
661290|NCT01843660|Primary|Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 4|Pain intensity was measured using NRS (0=painless and 10=most severe pain). Score of 1-3 means mild pain; 4-6 means moderate pain and 7-10 means severe pain.|Hour 4|Per protocol population included all participants who completed the clinical trial according to the trial protocol.||Units on a scale||Standard Deviation|Mean
661291|NCT01843660|Primary|Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 3|Pain intensity was measured using NRS (0=painless and 10=most severe pain). Score of 1-3 means mild pain; 4-6 means moderate pain and 7-10 means severe pain.|Hour 3|Per protocol population included all participants who completed the clinical trial according to the trial protocol.||Units on a scale||Standard Deviation|Mean
661292|NCT01843660|Primary|Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 2|Pain intensity was measured using NRS (0=painless and 10=most severe pain). Score of 1-3 means mild pain; 4-6 means moderate pain and 7-10 means severe pain.|Hour 2|Per protocol population included all participants who completed the clinical trial according to the trial protocol.||Units on a scale||Standard Deviation|Mean
661293|NCT01843660|Primary|Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 1|Pain intensity was measured using NRS (0=painless and 10=most severe pain). Score of 1-3 means mild pain; 4-6 means moderate pain and 7-10 means severe pain.|Hour 1|Per protocol population included all participants who completed the clinical trial according to the trial protocol.||Units on a scale||Standard Deviation|Mean
661294|NCT01843660|Primary|Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 0.5|Pain intensity was measured using NRS (0=painless and 10=most severe pain). Score of 1-3 means mild pain; 4-6 means moderate pain and 7-10 means severe pain.|Hour 0.5|Per protocol population included all participants who completed the clinical trial according to the trial protocol.||Units on a scale||Standard Deviation|Mean
661299|NCT01843374|Secondary|Durable Disease Control Rate by Treatment Arm|Durable disease control rate (DDCR) is defined as the percentage of participants with best response of complete response (CR), partial response (PR), or stable disease (SD) of ≥ 6 months duration|Time from randomization to disease progression or death, whichever occurs first, assessed up to 3 years.|ITT population||Percentage|Participants|95% Confidence Interval|Number
661300|NCT01843374|Secondary|Disease Control Rate by Treatment Arm|Disease control rate (DCR) is defined as the proportion of participants with best response of complete response (CR), partial response (PR), or stable disease (SD) of ≥ 12 weeks duration|Time from randomization to disease progression or death, whichever occurs first, assessed up to 3 years.|ITT population||Percentage|Participants|95% Confidence Interval|Number
661301|NCT01843374|Secondary|Duration of Response by Treatment Arm|Duration of response will be defined as the duration from the first documentation of complete response (CR), partial response (PR) to the first documented disease progression.|Duration of response from the first documentation of objcetive response (confirmed CR or PR) to the first documented disease progression, assessed up to 14 weeks after the initial response.|ITT||Months|Participants|Full Range|Median
661302|NCT01843374|Secondary|Overall Response Rate by Treatment Arm|Overall response rate is defined as the proportion of participants with confirmed CR or PR per the modified Response Evaluation Criteria in Solid Tumours (RECIST) for pleural mesothelioma or RECIST v1.1 for peritoneal mesothelioma and assessed by computed tomography (CT) or magnetic resonance imaging (MRI). Complete Response (CR) corresponds to disappearance of all target lesions, and Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions. Overall Response (OR) = CR + PR.|Time from randomization to best response to treatment, assessed up to 3 years.|ITT population||Percentage|Participants|95% Confidence Interval|Number
661303|NCT01843374|Secondary|Progression-free Survival by Treatment Arm|Progression-free survival will be measured from randomization to the first documentation of disease progression or death due to any cause, whichever occurs first. Progression is defined using the modified Response Evaluation Criteria in Solid Tumours (RECIST) for pleural mesothelioma or RECIST v1.1 for peritoneal mesothelioma and assessed by computed tomography (CT) or magnetic resonance imaging (MRI), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Time from randomization to disease progression or death, whichever occurs first, assessed up to 3 years.|ITT population||Months|Participants|95% Confidence Interval|Median
661304|NCT01843374|Secondary|OS Rate at 18 Months by Treatment Arm|The percentage of patients still alive at 18 months|18 months|ITT population||Percentage of Participants|Participants|95% Confidence Interval|Number
661305|NCT01843374|Primary|Overall Survival (OS)|Overall survival (OS) by treatment arm|3 years.|ITT population||Number of Participants|Participants||Number
661306|NCT01843348|Secondary|Duration of Wound Healing|A wound will be considered healed if all the suture material and staples are removed and the wound is intact. Number of participants is based on all patients of the respective treatment group in the safety set, excluding patients with no answer (unknown).|Post transplant until individual reporting|||days||Standard Deviation|Mean
661307|NCT01843348|Secondary|Percent of Participants With Wound Healing Complications During Study|Information collected to report wound healing process which included percentage of participants with complications, fluid collections detected and occurrence of lymphoceles|Post transplant until individual reporting|||Percent of participants|||Number
661308|NCT01843348|Secondary|Percent of Participants With Viral Infections|Viral infections for BKV Virus Humane Polyomavirus 1 and Cytomegalovirus|Post transplant to month 12|Safety set||Percent of participants|||Number
661309|NCT01843348|Secondary|Percent of Participants With Delayed Graft Function by Day|Delayed graft function (DGF) was defined as the need for dialysis within the first 7 days post-transplantation, excluding the first post-transplantation day.|Post transplant up to day 7|Full analysis set||Percent of participants|||Number
661310|NCT01843348|Secondary|Percent of Participants With Delayed Graft Function and Slow Graft Function|Delayed graft function (DGF) was defined as the need for dialysis within the first 7 days post-transplantation, excluding the first post-transplantation day. Slow graft function (SGF) was defined as a serum creatinine >3.0 mg/dL at Day 5 post-transplantation. Full analysis set|Post transplant to month 12|Full analysis set||Percent of participants|||Number
661311|NCT01843348|Secondary|Percentage of Participants With Treatment Failure Endpoints at Month 12|Treatment failure endpoints: biopsy proven acute rejection (BPAR) defined as a rejection which was acute and proven by biopsy, graft loss (GL) defined as: allograft was presumed to be lost on the day the patient starts dialysis and not able to be removed from dialysis or death. Patients who prematurely discontinued the study: if the patient did not suffer from an event before discontinuation and reason was not related to efficacy, the patient was assessed as having had no event, otherwise the patient was assessed as having had an event. Full analysis set (FAS)|Month 12 post transplant|||Percentage of participants|||Number
661312|NCT01843348|Secondary|Glomular Filtration Rate (GFR) Via Modification of Diet in Renal Disease (MDRD) Method at Month 12 Post Transplant|Modification of Diet in Renal Disease (MDRD) = For men: GFR = 170 x (serum creatinine -0,999) x (age-0,176) x (urea nitrogen -0,17) x (albumin0,318) For women: GFR = 170 x (serum creatinine -0,999) x (age-0,176) x (urea nitrogen -0,17) x albumin0,318) x 0.762 with urea nitrogen = urea / 2.144. last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model|Month 12 post transplant|Full analysis set||mL/min per 1.73m²||95% Confidence Interval|Least Squares Mean
661313|NCT01843348|Secondary|Glomular Filtration Rate (GFR) mL/Min Via Cockcroft- Gault Method at Month 12 Post Transplant|Cockcroft-Gault formula: For men: GFR= ((140-age) × body weight in kg)∕(72 x serum creatinine in mg∕dl)For women: GFR= (0.85×(140-age) × body weight in kg)∕(72 x serum creatinine in mg/dl), ), last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model|Month 12 post transplant|Full analysis set||mL/min per 1.73m²||95% Confidence Interval|Least Squares Mean
661314|NCT01843348|Secondary|Glomular Filtration Rate (GFR) Via Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Method at Month 12 Post Transplant|Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) method = GFR=141 x min(Scr/κ, 1)α x max(Scr/κ, 1)1.209 x 0.993Age x 1.018 [if female] x 1.159 [if black] where Scr is serum creatinine, κ is 0.7 for females and 0.9 for males, α is 0.329 for females and 0.411 for males, min indicates the minimum of Scr/κ or 1, and max indicates the maximum of Scr/κ or 1. last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model|Month 12 post transplant|Full analysis set||mL/min per 1.73m²||95% Confidence Interval|Least Squares Mean
661315|NCT01843348|Secondary|Percentage of Participants With Composite Treatment Failure Endpoints - Difference Between Groups at Month 12|Combined endpoint included: biopsy proven acute rejection (BPAR) defined as a rejection which was acute and proven by biopsy, graft loss (GL) defined as: allograft was presumed to be lost on the day the patient starts dialysis and not able to be removed from dialysis or death. Patients who prematurely discontinued the study: if the patient did not suffer from an event before discontinuation and reason was not related to efficacy, the patient was assessed as having had no event, otherwise the patient was assessed as having had an event. Full analysis set (FAS)|Month 12 post transplant|Full analysis set includes all participants who received at least one dose of study drug.||Percentage of participants|||Number
661316|NCT01843348|Primary|Glomular Filtration Rate (GFR) mL/Min Via Nankivell Method at Month 12 - Standard Regimen vs Certican Regimens|"To demonstrate non-inferiority in renal function assessed by glomerular filtration rate (Nankivell formula) in at least one of the Certican® treatment regimens compared to the standard regimen group at month 12 post-transplantation in renal transplant patients. Nankivell formula:
GFR = 6.7/Scr + BW/4 – Surea/2 – 100/(height)² + C where Scr is the serum creatinine concentration expressed in mmol/L, BW the body weight in kg, Surea the serum urea in mmol/L, height in m, and the constant C is 35 for male and 25 for female patients. The eGFR is expressed in mL/min per 1.73m². If a patient was on dialysis at the time of urea or creatinine assessment, the eGFR was set to 0. Analysis set = per protocol set"|One year post transplant|Protocol analysis set comprised of participants who received at least one dose of study drug without major protocol deviaitons||mL/min per 1.73m²||Standard Deviation|Mean
661317|NCT01843192|Secondary|Number of Subjects With 1 Chest Tube Placed|All subjects had either 1 or 2 chest tubes placed during surgery. Results presented are for the percentage of subjects with 1 chest tube placed.|During surgery|All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure||percentage of participants|||Number
661318|NCT01843192|Secondary|Occurrence of Intra-operative Leak Test|This outcome was scored as Yes or No based on whether a leak was detected during an intra-operative leak test when it was performed. Not all subjects had an intra-operative leak test performed, as it was not standard of care at all participating institutions, and so results are only presented for those subjects in whom an intra-operative test was performed.|During surgery|All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure. This analysis was further restricted to those subjects in whom an intra-operative leak test was actually performed, as it was not standard of care at all participating institutions.||participants|||Number
661319|NCT01843192|Secondary|Operative Time|Defined as the duration in hours from the first skin incision to the closure of the last incision|Day of surgery|All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure||hours||Standard Deviation|Mean
661320|NCT01843192|Secondary|Time to Chest Tube Removal|Defined as the number of days from date of surgery to removal of the last chest tube inserted during the surgical procedure.|Post-operative period through hospital discharge and follow-up at Day 30|All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure||days||Standard Deviation|Mean
661321|NCT01843192|Secondary|Volume of Estimated Intra-operative Blood Loss||Blood loss intra-op and up to 5 days post-op|All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure||milliliters||Standard Deviation|Mean
661322|NCT01843192|Secondary|Length of Stay (LOS)|Determined as the length of time in days from hospital admission to initial hospital discharge|Post-operative period through hospital discharge and follow-up at Day 30|All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure||days||Standard Deviation|Mean
661323|NCT01843192|Primary|Occurrence of Prolonged Air Leaks|Prolonged air leaks defined as longer than 5 days in continuous duration. Air leak was to be quantitatively assessed starting on the evening after surgery and then twice daily (during morning and evening rounds) as described by Certfolio et al. 2001. Patients were instructed to perform standardized repeated forced expiratory maneuvers (coughing and blowing). Leaks were scored using the air-leak meter that comes as part of a pleura vac system from 1 to 7, with 7 being the highest (most chambers).|Post-operative period through hospital discharge and follow-up at Day 30|All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure||percentage of participants||95% Confidence Interval|Number
661324|NCT01843192|Primary|Occurrence of Postoperative Air Leaks|Air leak was to be quantitatively assessed starting on the evening after surgery and then twice daily (during morning and evening rounds) as described by Certfolio et al. 2001. Patients were instructed to perform standardized repeated forced expiratory maneuvers (coughing and blowing). Leaks were scored using the air-leak meter that comes as part of a pleura vac system from 1 to 7, with 7 being the highest (most chambers).|Post-operative period through hospital discharge and follow-up at Day 30|All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure||percentage of participants||95% Confidence Interval|Number
661325|NCT01842906|Secondary|Nocturnal Awakenings|Number of nocturnal desaturations will be measured by Watch-PAT200, a wristwatch type continuous sleep cycle and pulse oximetry analyzer. Study participants will be followed approximately for 10 hours, from when they go to sleep until awakening the next morning.|approximately 10 hours|||Number of events||Inter-Quartile Range|Median
661326|NCT01842906|Secondary|Acute Mountain Sickness Severity|Severity of acute mountain sickness will be evaluated by the Lake Louise Criteria (0-15 point scale) with higher scores representing more severe symptoms. Study participants will be followed approximately for 10 hours, from when they go to sleep until awakening the next morning.|approximately 10 hours|Severity||unit on a scale||Inter-Quartile Range|Median
661327|NCT01842906|Secondary|Number of Nocturnal Desaturations|Number of nocturnal desaturations will be measured by Watch-PAT200, a wristwatch type continuous sleep cycle and pulse oximetry analyzer. Study participants will be followed approximately for 10 hours, from when they go to sleep until awakening the next morning.|Approximately 10 hours|||Number of events||Standard Deviation|Mean
661330|NCT01842841|Secondary|Number of Participants With Change From Baseline in Neurological Status at Week 103|Neurological status was considered normal or abnormal based on investigator’s discretion. Week 51 of Study HGT-GCB-087 (NCT01614574) was considered as baseline for this endpoint.|Baseline, Week 103|Safety population. Number of participants analyzed signifies participants evaluable for this outcome.||participants|||Number
661331|NCT01842841|Secondary|Change From Baseline in Plasma Chitotriosidase Levels at Week 101|Plasma chitotriosidase activity levels were measured using an enzymatic assay with 4-methylumbelliferyl-deoxychitobiose as a substrate. Week 51 of Study HGT-GCB-087 (NCT01614574) was considered as baseline for this endpoint.|Baseline, Week 101|Safety population. Number of participants analyzed signifies participants who were not deficient at baseline in chitotriosidase activity or who did not have a 24 base pair duplication in either copy of the chitotriosidase gene.||nanomole/milliliter/hour (nmol/mL/h)||Standard Deviation|Mean
661332|NCT01842841|Secondary|Change From Baseline in Skeletal Age at Week 103: Z-Score|Skeletal age was measured via radiography (X-ray) of the left hand and wrist by the method of Greulich and Pyle. The Z-score, or Standard Deviation Score, is a measure of number of SDs above or below the average BMD of a healthy participant of the same age and gender. Statistical analysis plan only required summarization if >50% of participants had evaluable data. Week 51 of Study HGT-GCB-087 (NCT01614574) was considered as baseline for this endpoint.|Baseline, Week 103|Data was not reported as there was <50% of participants had evaluable data.|||||
661333|NCT01842841|Secondary|Change From Baseline in Growth Velocity at Week 101 : Height Z-Score|The Z-score, or Standard Deviation Score, is a measure of number of SDs above or below the average BMD of a healthy participant of the same age and gender. World Health Organization 2007 growth reference data were used for Z-score calculation. Statistical analysis plan only required summarization if >50% of participants had evaluable data. Week 51 of Study HGT-GCB-087 (NCT01614574) was considered as baseline for this endpoint.|Baseline, Week 101|Data was not reported as there was <50% of participants had evaluable data.|||||
661334|NCT01842841|Secondary|Change From Baseline in Bone Marrow Burden (BMB) Score at Week 103|BMB Score was measured using MRI, range from 0 (no abnormalities) to 8 points (severe disease) for the lumbar spine and from 0 (no abnormalities) to 8 points (severe disease) for the femurs. The total score was calculated as the sum of scores for femur and lumbar spine regions which ranged from 0-16 points. A higher BMB score signified more severe bone marrow involvement. Week 51 of Study HGT-GCB-087 (NCT01614574) was considered as baseline for this endpoint.|Baseline, Week 103|Safety population.||units on a scale||Standard Deviation|Mean
661335|NCT01842841|Secondary|Change From Baseline in Bone Mineral Density (BMD) at Week 103: T-Score|BMD was measured by DXA for lumbar spine and femurs. To ensure standardization and allow for comparisons of BMD, results were converted to standardized T-scores; normal values were used from databases from Hologic based on standard criteria. T-scores are the number of SDs above or below the average for a young adult at peak BMD. Statistical analysis plan only required summarization if >50% of participants had evaluable data. Week 51 of Study HGT-GCB-087 (NCT01614574) was considered as baseline for this endpoint.|Baseline, Week 103|Data was not reported as there were <50% of participants with evaluable data.|||||
661336|NCT01842841|Secondary|Change From Baseline in Bone Mineral Density (BMD) at Week 103: Z Score|BMD was measured by dual energy x-ray absorptiometry (DXA) for lumbar spine and femurs. To ensure standardization and allow for comparisons of BMD, results were converted to standardized Z-scores (matched for age and gender). Z-scores express the BMD as the number of standard deviations (SDs) above or below the average BMD of a healthy participant of the same age and gender. Statistical analysis plan only required summarization if greater than (>) 50 percent (%) of participants had evaluable data. Week 51 of Study HGT-GCB-087 (NCT01614574) was considered as baseline for this endpoint.|Baseline, Week 103|Data was not reported as there were lesser than (<) 50% of participants with evaluable data.|||||
661337|NCT01842841|Secondary|Change From Baseline in Spleen Volume Normalized to Body Weight at Week 103|Spleen volume was measured using MRI. Spleen volume measurements were normalized to the percentage of body weight. Week 51 of Study HGT-GCB-087 (NCT01614574) was considered as baseline for this endpoint.|Baseline, Week 103|Safety population||Percentage of body weight||Standard Deviation|Mean
661338|NCT01842841|Secondary|Change From Baseline in Liver Volume Normalized to Body Weight at Week 103|Liver volume was measured using magnetic resonance imaging (MRI). Liver volume measurements were normalized to the percentage of body weight. Week 51 of Study HGT-GCB-087 (NCT01614574) was considered as baseline for this endpoint.|Baseline, Week 103|Safety population||Percentage of body weight||Standard Deviation|Mean
661339|NCT01842841|Secondary|Change From Baseline in Platelet Count at Week 101|Baseline was the modified baseline platelet count, the average of the values from screening, baseline, and Week 1 Day 1 from Study HGT-GCB-087 (NCT01614574).|Baseline, Week 101|Safety population||*10^9 platelets per liter||Standard Deviation|Mean
661340|NCT01842841|Secondary|Change From Baseline in Hemoglobin Concentration at Week 101|Baseline was the modified baseline hemoglobin concentration, the average of the values from screening, baseline, and Week 1 Day 1 from Study HGT-GCB-087 (NCT01614574).|Baseline, Week 101|Safety population||gram per deciliter (g/dL)||Standard Deviation|Mean
661341|NCT01842841|Primary|Number of Participants With Positive Anti-Velaglucerase Alfa Antibodies|Serum samples were collected for all participants for determination of anti-velaglucerase alfa antibodies every 12 weeks.|From Week 65 until the end of study (Week 155)|Safety population.||participants|||Number
661342|NCT01842841|Primary|Number of Participants With Abnormal and Clinically Significant Laboratory Test Results|Laboratory test results were considered abnormal and clinically significant at the discretion of the investigator.|From Week 65 until the end of study (Week 155)|Safety population.||participants|||Number
661343|NCT01842841|Primary|Number of Participants Using Concomitant Medication||From the day of first infusion (Week 53) up to 30 days after last infusion (approximately 107 weeks)|Safety population.||participants|||Number
661358|NCT01842633|Secondary|Global Evaluation of Response to Treatment|Global evaluation of treatment response was measured by a score in a scale from: 0-very poor, 1-poor, 2-neutral [neither poor nor good], 3-good, or 4-very good).|4 hours|ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment.||score on a scale||Standard Deviation|Mean
661489|NCT01838941|Primary|Peroxisome Biochemical Functions as Measured by Plasma Very Long Chain Fatty Acid|C26/C22 ratio in plasma is a recognized biomarker for very long chain fatty acid (normal range: 0.002-0.018). It was measured twice before the beginning of treatment and measured once at the end.|6 months|||ratio||Full Range|Mean
661344|NCT01842841|Primary|Number of Participants With Drug-related Adverse Events (AEs), Infusion-related AEs, and Serious AEs (SAEs)|An AE was any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in any phase of a clinical study, whether or not considered related to investigational product. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. An infusion-related AE was defined as an AE that started either during or within 12 hours after the start of the infusion and that was judged as possibly or probably related to investigational product.|From the day of first infusion (Week 53) up to 30 days after last infusion (approximately 107 weeks)|Safety population.||participants|||Number
661345|NCT01842789|Secondary|Recovery Time|Patients to be followed for 1 to 2 months post-treatment to evaluate recovery.|1 to 2 months|All subjects followed for 1 to 2 months post treatment.||days||Full Range|Median
661346|NCT01842789|Primary|Number of Minutes From Visualizing the Target to Reaching the Target|To measure difference in time to target with and without the use of TAG. This is a time and motion study, with time measured at each stage of the procedure. The most important subject variable to consider was number of fibroids targeted, which influenced overall procedure time.|Intraoperative|All participants undergoing treatment with Acessa (with or without targeting animation guidance).||Minutes per fibroid treated||Full Range|Mean
661347|NCT01842789|Primary|Physician Feedback Regarding TAG System Use During Surgery.|Physician preference testing is assessed by the completion of a questionnaire using a 5 point rating system ranging from “strongly agree” (a rating of 5) to “strongly disagree” (a rating of 1) regarding the use of the TAG system. The questions included are in regards to ease of targeting, ease of visualizing the target, the addition of specific features that enhance user interface and the overall set-up.|Physicians have up to 1 hour after the procedure to fill out the questionnaire|All subjects in whom TAG was used as an accessory system. This outcome measure was specific to this arm of the study only. Physicians provided feedback regarding use of the accessory system but did not provide feedback regarding the standard system without guidance. Physicians rated the system on a scale of 1 Strongly disagree to 5 Strongly agree.||units on a scale||Standard Deviation|Mean
661348|NCT01842646|Secondary|Treatment Emergent Adverse Events|Treatment emergent adverse events occurring in equal to or more than 10% of participants.|2 years, 4 months|All participants||Participants|||Count of Participants
661349|NCT01842646|Secondary|Median Time to Transformation to Acute Myeloid Leukemia (AML)|To estimate the time to transformation to AML in patients with <20% blasts. In patients with less than 20% blasts, the time to transformation to AML will be defined as the date of the first dose of drug until either the percentage of bone marrow blasts or the percentage of peripheral blasts exceeds 20%, whichever is first.|Up to 2 years, 4 months||02/2018||||
661350|NCT01842646|Secondary|Median Event Free Survival|To estimate the event-free survival of patients of this population. Event-free survival will be defined as the date of the first dose of study drug until failure or death from any cause.|Up to 2 years, 4 months||02/2018||||
661351|NCT01842646|Secondary|Median Overall Survival (OS)|To estimate the overall survival of patients with refractory/relapsed myelodysplastic Syndrome (MDS) and chronic myelo-monocytic leukemia (CMML) treated with PF-0444913. Overall survival will be defined as the time period between the date of the first dose of drug until the time of death.|Up to 2 years, 4 months|All participants||months||95% Confidence Interval|Median
661352|NCT01842646|Primary|Overall International Working Group (IWG) 2006 Response Rate|Response recorded from the start of the treatment until disease progression/recurrence. All responses must last for at least 8 weeks. Complete Remission (CR): Bone marrow: ≤ 5% myeloblasts with normal maturation of all cell lines, Persistent dysplasia will be noted, Peripheral blood: Hemoglobin ≥ 11 g/dL, Platelets ≥ 100 x 10^9/L, Neutrophils ≥ 1.0 x 10^9/L, Blasts 0% ; Partial Remission (PR): All CR criteria if abnormal before treatment, except: Bone marrow blasts decreased by ≥ 50% over pretreatment but still > 5%, Cellularity and morphology not relevant; Marrow CR or Hematological Improvement (HI): Bone marrow: ≤ 5% myeloblasts and decrease by ≥ 50% over pretreatment Peripheral blood: if HI responses, they will be noted in addition to marrow CR. Further investigation of PF-04449913 would not be warranted if it produced an overall response rate (CR + PR + marrow CR+HI) of 10% or less (p0), and would be warranted if it produced an overall response rate of 30% or more (p1).|Up to 2 years, 4 months|All participants||Participants|||Count of Participants
661353|NCT01842633|Secondary|Time to the Use of Rescue Medication.|Time taken by the participants to use the rescue medication|Up to 4 hours|ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment||Minutes||Standard Deviation|Mean
661354|NCT01842633|Secondary|Number of Pain Free Participants|Number of participants with complete relief was calculated as the number of participants who reported PRS = 4-complete relief at 1 hour and 2 hours post dose.|1 hour and 2 hour post dose|ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment.||number of participants|||Number
661355|NCT01842633|Secondary|Headache Relief|The participant assessed headache relief of each treated qualifying headache at 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 180, and 240 minutes post treatment on a 5-point scale (0-no relief, 1-a little relief, 2-some relief, 3-a lot of relief, and 4-complete relief). higher headache relief score indicates better outcome.|At 10 min. 15 min., 20 min., 25 min., 30 min., 40 min., 50 min., 60 min., 90 min., 120 min., 180 min., 240 min.,|ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment.||score on a scale||Standard Deviation|Mean
661356|NCT01842633|Secondary|Change From Baseline in Headache Pain Intensity|Change from baseline in headache pain intensity was calculated as the change (difference) from baseline PI with PI at each time-point. PI was assessed on a 4-point scale (0-no headache, 1-mild headache, 2-moderate headache, 3-severe headache).|At 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 180, and 240 min.|ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment.||score on a scale||Standard Deviation|Mean
661357|NCT01842633|Secondary|Rate of Rescue Medication|Number of participants that took rescue medication over the total number of participants for a given treatment group|4 hours|ITT population defined as all participants who received treatment, who took rescue medication and who had at least one post-baseline efficacy assessment.||number of participants|||Number
661359|NCT01842633|Secondary|Area Under the Time-Response Curve for Change in Headache Intensity and Headache Relief (SPRID)|SPRID was measured as sum of TOTPAR and SPID. SPID and TOTPAR were calculated as weighted sums of PID and PRS at each measurement time point, respectively. PID at each time point was calculated as difference of PI at baseline (prior to the first dose) with PI at a given time point. PI was assessed on a 4-point scale (0-no headache, 1-mild headache, 2-moderate headache, 3-severe headache). PRS was assessed on a 5-point scale (0-no relief, 1-a little relief, 2-some relief, 3-a lot of relief, and 4-complete relief). The range of SPRID for different time points were as follow: from-3 to 5 for SPRID at 1 hour post dose, from -6 to 10 for SPRID at 2 hours post dose, from -9 to 15 for SPRID at 3 hours post dose, and from -12 to 20 for SPRID at 4 hours post dose.|From (Baseline) 0 to 1 hour, 0 to 2 hours, 0 to 3 hours and 0 to 4 hours post dose|ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment.||score on a scale||Standard Deviation|Mean
661360|NCT01842633|Secondary|Total Pain Relief (TOTPAR)|TOTPAR was calculated as the weighted sum of pain relief scores (PRS) at each time point. PRS was assessed on a 5-point scale (0-no relief, 1-a little relief, 2-some relief, 3-a lot of relief, and 4-complete relief). The range for TOTPAR for different time points were as follows: from 0 to 4 for TOTPAR at 1 hour post dose, from 0 to 8 for TOTPAR at 2 hours post dose, from 0 to 12 for TOTPAR at 3 hours post dose, and from 0 to 16 for TOTPAR at 4 hours post dose.|From (Baseline) 0 to 1, from 0 to 2, from 0 to 3 and from 0 to 4 hour post dose|ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment.||score on a scale||Standard Deviation|Mean
661361|NCT01842633|Secondary|Time to Meaningful Headache Relief|Time to meaningful headache relief was assessed as time when participants reported a PRS ≥ 2.|Baseline up to 4 hours|ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment.||min.||Full Range|Median
661362|NCT01842633|Secondary|Number of Participants With Meaningful Pain Relief||Baseline up to 4 hours|ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment.||number of participants|||Number
661363|NCT01842633|Secondary|Time to Perceptible Headache Relief|Time to perceptible headache relief was assessed as the time when participants achieve pain relief scores (PRS) more than or equal to 1.|Baseline up to 4 hours|ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment.||minutes (min.)||Full Range|Median
661364|NCT01842633|Secondary|Number of Participants With Perceptible Pain Relief||Baseline up to 4 hours|ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment.||number of participants|||Number
661365|NCT01842633|Secondary|Sum of Pain Intensity Difference (SPID) at 1, 2 and 3 Hours|"SPID was calculated as the weighted sum of Pain (Headache) intensity differences at 1, 2 and 3 hours post dose.
The time-intervals used were 0-10, 10-15, 15-20, 20-25, 25-30, 30-40, 40-50, 50-60 minutes for SPID at 1 hour post dose. The range of SPID at 1 hour post dose was from -3 to 1. The time-intervals used were 0-10, 10-15, 15-20, 20-25, 25-30, 30-40, 40-50, 50-60, 60-90, 90-120 minutes for SPID at 2 hours post dose . The range of SPID at 2 hours post dose was from -6 to 2. The time-intervals used were 0-10, 10-15, 15-20, 20-25, 25-30, 30-40, 40-50, 50-60, 60-90, 90-120, 120-180 minutes for SPID at 3 hours post dose. The range of SPID at 3 hours post dose was from -9 to 3. PID was calculated as difference of pain intensity (PI) at baseline (prior to the first dose) with PI at a given time point. PI was assessed on a 4-point scale (0-no headache, 1-mild headache, 2-moderate headache, 3-severe headache)."|From (Baseline) 0 to 1 hour, 0 to 2 hours, and 0 to 3 hours post dose|ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment.||score on a scale||Standard Deviation|Mean
661366|NCT01842633|Primary|Sum of Pain Intensity Difference (SPID) of Treatment and Placebo at 4 Hours|"SPID was calculated as the weighted sum of Pain (Headache) intensity differences at 4 hours post dose. The time-intervals used were 0-10, 10-15, 15-20, 20-25, 25-30, 30-40, 40-50, 50-60, 60-90, 90-120, 120-180, 180-240 minutes. The range of SPID at 4 hours post dose was from -12 to 4. PID was calculated as difference of pain intensity (PI) at baseline (prior to the first dose) with PI at a given time point. PI was assessed on a 4-point scale (0-no headache, 1-mild headache, 2-moderate headache, 3-severe headache)."|Up to 4 hours post dose|Intention-to-treat (ITT) population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment.||score on a scale||Standard Deviation|Mean
661367|NCT01842607|Secondary|Number of Participants With Haematology Laboratory Parameters Outside the Normal Range at Any Time Post-baseline|Haematology laboratory parameters included basophils, basophils/leukocytes, blood erythrocytes, blood leukocytes, eosinophils, eosinophils/leukocytes, mean corpuscular hemoglobin concentration (MCHC), mean corpuscular hemoglobin (MCH), mean corpuscular volume (MCV), erythrocytes distribution width (EDW), hematocrit, hemoglobin, lymphocytes, lymphocytes/leukocytes, monocytes, monocytes/leukocytes, neutrophils segmented (NS), neutrophils/leukocytes, platelets, reticulocytes assessed at Baseline, Week 4, Week 16, Week 28, Week 52 and follow-up visit (approx. 12 weeks post-last dose). Hematology abnormalities outside the normal range (high and low values) at any time post baseline were presented. Any time post Baseline is equal to all visits (including scheduled and unscheduled) post Baseline were considered for this visit derivation. If participant had given both high and low value at least once then participant is counted under both high and low category for this visit.|From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])|AT Population, Only those participants available at the specified time points were analyzed ( n=X in the category titles).||Participants|||Number
661375|NCT01842607|Secondary|Number of Participants With Systemic (i.e., Allergic/IgE-mediated and Non-allergic) and Local Site Reactions|Participants were monitored to evaluate the AEs of systemic and local site reaction. AE is defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Hypersensitivity reactions (i.e., allergic or IgE-mediated reactions) were monitored using the diagnostic criteria for anaphylaxis as outlined by the 2006 Joint NIAID/FAAN Second Symposium on Anaphylaxis. Information was also collected to assess localized site reactions as determined by the investigator. On treatment AEs were defined as events occurring from the first dose until 28 days after the last dose of mepolizumab.|From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])|AT Population||Participants|||Number
661368|NCT01842607|Secondary|Number of Participants With Clinical Chemistry Parameters Outside the Normal Range at Any Time Post-baseline|Clinical chemistry laboratory parameters included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, calcium, chloride, cholesterol, creatine kinase, creatinine, direct bilirubin, gamma glutamyl transferase, high density lipoprotein (HDL) cholesterol, indirect bilirubin, low density lipoprotein (LDL) cholesterol, lactate dehydrogenase, phosphate, plasma/serum protein, potassium, serum glucose, sodium, triglycerides, urea, and very low density lipoprotein (VLDL) cholesterol assessed at the indicated time points. Laboratory abnormalities outside the normal range (high and low values) at any time post baseline were presented. Any time post Baseline = all visits (including scheduled and unscheduled). If participant had given both high and low value at least once then participant is counted under both high and low category for this visit.|From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])|AT Population, Only those participants available at the specified time points were analyzed ( n=X in the category titles).||Participants|||Number
661369|NCT01842607|Secondary|Change From Baseline in Pulse Rate Assessed at Week 52|Vital sign measurements including sitting pulse was performed at Baseline, at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and follow-up visit (approx. 12 weeks post-last dose). Vital measurements were done pre-injection with the participants sitting, having rested in this position for at least 5 minutes before each reading. They were taken before measurement of any clinic lung function tests or ECGs at the specified time point.|Baseline and Week 52|AT Population, Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).||Beats per minute (BPM)||Standard Deviation|Mean
661370|NCT01842607|Secondary|Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Assessed at Week 52|Vital sign measurements including systolic blood pressure (SBP) and diastolic blood pressure (DBP) were performed at Baseline, at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and follow-up visit (approx. 12 weeks post-last dose). Vital measurements were done pre-injection with the participants sitting, having rested in this position for at least 5 minutes before each reading. They were taken before measurement of any clinic lung function tests or ECGs at the specified time point.|Baseline and Week 52|AT Population, Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).||Millimeter of mercury (mmHg)||Standard Deviation|Mean
661371|NCT01842607|Secondary|Number of Participants With Maximum Change From Baseline in QTcB Interval for ECG Assessed at Any Time Post Baseline|12-lead ECG measurements were recorded after the participant has rested in the supine position for 5 minutes. ECG was performed at Baseline, Week 28, Week 52 and at the end of follow-up period (approx. 12 weeks post-last dose). Participants with maximum change (MC) from Baseline were summarized at any time post Baseline for the following categories <-60, >=-60 to <-30, >=-30 to <0, >=0 to <30, >=30 to <60 and >=60. The change from Baseline is defined as the difference between the value of the end point at the time point of interest and Baseline value. QTc intervals shown at any time post Baseline are the maximum seen in each participant over the course of the trial. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])|AT Population, Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).||participants|||Number
661372|NCT01842607|Secondary|Number of Participants With Maximum Change From Baseline in QTcF Interval for ECG Assessed at Any Time Post Baseline|12-lead ECG measurements were recorded after the participant has rested in the supine position for 5 minutes. ECG was performed at Baseline, Week 28, Week 52 and at the end of follow-up period (approx. 12 weeks post-last dose). Participants with maximum change (MC) from Baseline were summarised at any time post Baseline for the following categories <-60, >=-60 to <-30, >=-30 to <0, >=0 to <30, >=30 to <60 and >=60. The change from Baseline is defined as the difference between the value of the end point at the time point of interest and Baseline value. QTc intervals shown at any time post Baseline are the maximum seen in each participant over the course of the trial.|From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])|AT Population, Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).||Participants|||Number
661373|NCT01842607|Secondary|Mean Change From Baseline in QT Interval Corrected by Bazett's Method (QTcB) and QT Interval Corrected by Fridericia's Method (QTcF) Values for ECG Assessed at Baseline, Week 28, Week 52 and at Follow-up Visit (Approx. 12 Weeks Post-last Dose)|12-lead ECG measurements were recorded after the participant has rested in the supine position for 5 minutes. The ECG was obtained before lung function testing followed by other study procedures. ECG was performed at Baseline, Week 28, Week 52 and at the end of follow-up period (approx. 12 weeks post-last dose). The change from Baseline is defined as the difference between the value of the end point at the time point of interest and Baseline value.|From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])|AT Population, Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).||Milliseconds (msec)||Standard Deviation|Mean
661374|NCT01842607|Secondary|Number of Participants With Electrocardiogram (ECG) Findings at Any Time Post Baseline|12-lead ECG measurements were recorded after the participant has rested in the supine position for 5 minutes. The ECG was obtained before lung function testing followed by other study procedures. ECG was performed at Baseline, Week 28, Week 52 and at the end of follow-up period (approx. 12 weeks post-last dose). ECG findings were summarised at any time post Baseline for participants as normal, abnormal-not clinically significant(A-NCS) and abnormal-clinically significant (A-CS).|From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])|AT Population, only participants with ECG results post-baseline were analyzed||Participants|||Number
661376|NCT01842607|Secondary|Number of Participants Hospitalized Due to Exacerbations and Adverse Events|AE is defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Exacerbation is defined as worsening of asthma which requires use of systemic corticosteroids (IV or oral steroid like prednisone, for at least 3 days or a single intramuscular (IM) corticosteroid (CS) dose is required. For maintenance systemic corticosteroids, at least double the existing maintenance dose for at least 3 days was required) and/or hospitalization and/or emergency department (ED) visit.|From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])|AT Population||Participants|||Number
661377|NCT01842607|Secondary|Number of Participants Withdrawn Due to Lack of Efficacy and Adverse Events From the Study|AE is defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse.|From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])|AT Population.||Participants|||Number
661378|NCT01842607|Secondary|Mean Change From Baseline in Clinic Pre-bronchodilator FEV1 Over the 52-week Treatment Period|FEV1 is defined as the volume of air forcefully expelled from the lungs in 1 second. Pre-bronchodilator FEV1 measurements were taken by spirometry at Baseline, Week 16, Week 28 and Week 52. Spirometry was performed within ± 1 hour of the Baseline assessment. The change from Baseline is defined as the difference between the value of the end point at the time point of interest and Baseline value.|From Baseline and up to Week 52|AT Population, Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).||Milliliters (mL)||Standard Deviation|Mean
661379|NCT01842607|Secondary|Mean Change From Baseline in Asthma Control Questionnaire (ACQ) Score|The ACQ-5 is a five-item questionnaire developed as a measure of participants asthma control. The five questions enquire about the frequency and/or severity of symptoms (nocturnal awakening on waking in the morning, activity limitation, shortness of breath, wheeze). The response options for all these questions consist of a 0 (no impairment/limitation) to 6 (total impairment/ limitation) scale. The overall ACQ score is calculated as the mean of the 5 questions and therefore ranges between 0 (totally controlled) and 6 (severely uncontrolled). The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and Baseline value.|From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])|AT Population, Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).||Score on scale||Standard Deviation|Mean
661380|NCT01842607|Secondary|Annualized Rate of Exacerbations Per Year|Exacerbations are defined as the worsening of asthma which requires use of systemic corticosteroids (IV or oral steroid like prednisone, for at least 3 days or a single intramuscular (IM) corticosteroid (CS) dose is required. For maintenance systemic corticosteroids, at least double the existing maintenance dose for at least 3 days was required) and/or hospitalization and/or emergency department (ED) visit. Analysis of the number of exacerbations was performed using a negative binomial model with covariates of region, exacerbations in the year prior to the start of MEA115588 or MEA115575 (as an ordinal variable) and baseline percent (%) predicted forced expiratory volume in 1 second (FEV1), and with logarithm of time on treatment as an offset variable.|Baseline up to Exit Visit (approx. 52 weeks) or if Early Withdrawal 4 weeks post last dose|AT Population||Exacerbations per year||95% Confidence Interval|Mean
661381|NCT01842607|Secondary|Number of Participants With Positive Anti-mepolizumab Binding Antibodies and Neutralizing Antibodies (NAb) at the Indicated Time Points|Blood samples were collected for the determination of anti-mepolizumab antibodies (ADA) just prior to administration of mepolizumab at indicated time points. Samples that tested positive for anti-mepolizumab antibodies were further tested for the presence of NAb. Participants who switched from the 250 mg vial to the 100 mg vial required one immunogenicity sample prior to the first dose from the 100 mg vial and one sample prior to the second dose from the 100 mg vial at the next visit. The highest value post-baseline visit are based on each participant's highest post-baseline titer. NAb assay result was only presented for participants with positive ADA assay. Highest value post-baseline would be positive for a participant who had both negative and positive post-baseline results.|From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])|AT Population. Only those participants available at the indicated timepoints were analyzed (represented by n=X in the category titles).||Participants|||Number
661382|NCT01842607|Primary|Number of Participants With Adverse Events (AEs) Including Both Systemic (i.e. Allergic/Immunoglobulin (Ig)E-mediated and Non-allergic) and Local Site Reactions|AEs were collected from the Baseline visit until the follow-up visit (approx. 12 weeks post-last dose). Participants were monitored to evaluate the AEs of systemic and local site reaction. AE is defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. On treatment AEs were defined as events occurring from the first dose until 28 days after the last dose of mepolizumab.|From Baseline visit until the follow-up visit (approximately [approx.] week 60 [12 weeks post-last dose])|As Treated (AT) Population: all participants who received at least one dose of open label mepolizumab.||Participants|||Number
661383|NCT01842594|Secondary|The Toxicity|Number of Participants with Adverse Events. Toxicities parameters are according to the Nation Cancer Institute Common Terminology Criteria for Adverse Event, version 3.0.|2 Weeks|||participants|||Number
661384|NCT01842594|Primary|The Maximum Standardized Uptake Values (SUVmax) Change on PET/CT Scan|A baseline whole-body [18F]-fluorodeoxyglucose(FDG) PET was performed before therapy initiation. Patients received 1 mg of Rapa and 200 mg of HCQ twice a day before a meal for 2 weeks. A second [18F]-FDG PET was performed after treatment completion. SUVs were calculated for all lesions. Regions of interest (ROI) were contoured to represent tumors (>2 cm) and organs (lungs, spleen, and liver) on all transaxial and coronal slices. ROIs were normalized for injection dose and body weight, and the maximum voxel value was recorded for each region or organ. The highest SUV measured with increased uptake was considered the SUVmax. Correlative diagnostic CT examinations were used for accurate localization of the lesions. The most intense uptake at baseline was identified as the index lesion and evaluated for treatment response.|2 Weeks|||percentage of the SUVmax Change|Participants|95% Confidence Interval|Mean
661385|NCT01842464|Primary|Number of Participants Involving in Complications: Operative Damage and Bleeding, Post Operative Infection and Mesh Exposure|Number of participants involving in complications: operative damage and bleeding, post operative infection and mesh exposure.|one year|occurrence and severity of complication is recorded||participants|||Number
661386|NCT01842464|Primary|Efficacy of Sacro-Spinous Ligaments Anterior Apical Anchoring|Level of support with the Sacro-Spinous Ligaments Anterior Apical Anchoring higher than 4 centimeters above vaginal opening.|one year|||participants|||Number
661388|NCT01842438|Secondary|SCORE15 (Systemic Core Outcome Measure)|SCORE15 is an index of Family Function and Change, with 15 items. The potential range of scores is 15 to 75, with a lower score indicating higher family functioning. Total scores are reported in the data below.|Basline (T0), immediate post-intervention (T1) and 6 Months (T2)|Data received at each time-point was T0: intervention 42, control: 43; T1: intervention 36, control 36; T2 (as above) intervention 28, control 32||units on a scale||Standard Deviation|Mean
661389|NCT01842438|Secondary|HADS (Hospital Anxiety and Depression Scale)|"The HADS has two scales: one anxiety and one depression. It is validated with population norms. Results are presented for T2 (6 month follow-up) and split by Patient, Partner and again by Intervention, Control.
Responses are scored on a scale of 0–3 (3 indicates higher symptom frequencies. Scores for each subscale (anxiety and depression) range from 0 to 21 with scores categorized as follows: normal 0–7, mild 8–10, moderate 11–14, and severe 15–21. Scores for the entire scale (emotional distress) range from 0 to 42, with higher scores indicating more distress."|Basline (T0), immediate post-intervention (T1) and 6 Months (T2)|Data received at each time-point was T0: intervention, T1: immediately after intervention; T2 6months post intervention.||units on a scale||Standard Deviation|Mean
661390|NCT01842438|Primary|EPIC (Expanded Prostate Cancer Index Composite), Sexual Bother Subscale|EPIC is a quality of life tool used in prostate cancer studies, focused on physical and sexual outcomes. It is validated with population norms. We used the sexual bother sub-scale as the primary outcome measure; score range 0-400. A higher score indicates better function/better outcome.|Basline (T0), immediate post-intervention (T1) and 6 Months (T2)|Primary outcome was at T1, sample size at T1, n=21 intervention, n=22 control. Sample size at T2, n=13 intervention, n=14 control At T1 (immediate follow-up) 3 intervention patients had withdrawn and 4 control patients had withdrawn. The scale was completed only by patients (all of whom were men, by as study focused on prostate cancer).||units on a scale||Standard Deviation|Mean
661391|NCT01841970|Secondary|Mean Pain Score Based on the Visual Analog Pain Scale|Mean pain score based on the Visual Analog pain scale. Patient reported pain on 10 point scale where 0 =No Pain and > 0 = Pain with 10 being the worst.|Post treatment at Month 1, Month 3, Month 6|At Month 1, 3 and 6 the number of participants include patients followed through that time period. The remaining patients were lost to follow up.||units on a scale||Standard Deviation|Mean
661392|NCT01841970|Secondary|Pain Recorded Yes or No on Visual Analog Scale (VAS)|Patient reported pain on 10 point scale where 0 =No Pain and > 0 = Pain with 10 being the worst.|Post treatment at Month 1, Month 3, Month 6|At Month 1, 3 and 6 the number of participants include patients followed through that time period. The remaining patients were lost to follow up.||participants|||Number
661393|NCT01841970|Secondary|Recurrence of Symptoms That Had Resolved With Treatment|Number of patients with recurrence of symptoms defined as external thrombosed hemorrhoids, infection, mucous discharge, new fissure, stenosis and delayed healing.|Post treatment at Month 1, Month 3, Month 6|At Month 1, 3 and 6 the number of participants include patients followed through that time period. The remaining patients were lost to follow up.||Participants|||Count of Participants
661394|NCT01841970|Secondary|Incidence of Recurrence of Pre-procedure Symptoms|Recurrence of pre-procedure symptoms after initial improvement|Post treatment at Month 1, Month 3, and Month 6|||participants|||Number
661395|NCT01841970|Primary|Number of Participants With Resolution of Symptoms|The primary endpoint analysis was the resolution of symptoms, including resolution of bleeding and prolapse, if present prior to treatment|Post treatment at Month1, Month 3, Month 6|18 participants included. 2 participants were lost to follow up.||participants|||Number
661396|NCT01841697|Secondary|Percentage of Participants Achieving an A1C Goal <6.5% After 24 Weeks of Treatment|Participant whole blood samples were collected at Week 24 to determine the percentage of participants achieving A1C <6.5% at Week 24.|Week 24|Full analysis set population consists of all randomized participants who received at least one dose of study treatment and have a baseline measurement or a post-randomization measurement for the analysis endpoint subsequent to at least one dose of study treatment.||Percentage of participants|||Number
661397|NCT01841697|Secondary|Percentage of Participants Achieving an A1C Goal <7.0% After 24 Weeks of Treatment|Participant whole blood samples were collected at Week 24 to determine the number of participants achieving A1C <7.0% at Week 24.|Week 24|Full analysis set population consists of all randomized participants who received at least one dose of study treatment and have a baseline measurement or a post-randomization measurement for the analysis endpoint subsequent to at least one dose of study treatment.||Percentage of participants|||Number
661398|NCT01841697|Secondary|Change From Baseline in FPG at Week 24|Participant whole blood samples were collected after an overnight fast at baseline and Week 24 to determine the least squares mean change from baseline in participant FPG.|Baseline and Week 24|Full analysis set population consists of all randomized participants who received at least one dose of study treatment and have a baseline measurement or a post-randomization measurement for the analysis endpoint subsequent to at least one dose of study treatment.||mg/dL||95% Confidence Interval|Least Squares Mean
661399|NCT01841697|Primary|Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event|An adverse event is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an adverse event. Data presented below excludes data after initiation of glycemic rescue therapy.|Up to 24 weeks|All participants as treated population consists of all randomized participants who received at least one dose of trial treatment. Participants are included in the treatment group corresponding to the trial treatment they actually received.||Percentage of participants|||Number
661415|NCT01841567|Secondary|Number of Participants Rated 'Very Good to Excellent' for Comfort, Conformability and the Acceptability of the Dressing.|The comfort, conformability and the acceptability of the dressing were measured on all visit in the study, by a study nurses. The patient had to answer questions regarding, the size of the dressing, shape of the dressing, Visibility beneath the dressing, ease of the application of the dressing, ease of removal of the dressing, overall experience of the use of the dressing, notice any pain at dressing change, Comfort of their dressing, overall experience of their dressing. The patient could chose between 1 Good, 2 Very good, 3 Excellent.In most cases, the patient chose very good to excellent for both hip and knee surgery|7 days|||participants|||Number
661400|NCT01841697|Primary|Percentage of Participants Who Experienced at Least One Adverse Event|An adverse event is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an adverse event. Data presented below excludes data after initiation of glycemic rescue therapy.|Up to 27 weeks (including 3-week follow-up)|All participants as treated population consists of all randomized participants who received at least one dose of trial treatment. Participants are included in the treatment group corresponding to the trial treatment they actually received.||Percentage of participants|||Number
661401|NCT01841697|Primary|Change From Baseline in A1C at Week 24|A1C is a measure of the percentage of glycated hemoglobin in the blood. Participant whole blood samples were collected at baseline and Week 24 to determine the least squares mean A1C change from baseline.|Baseline and Week 24|Full analysis set population consists of all randomized participants who received at least one dose of study treatment and have a baseline measurement or a post-randomization measurement for the analysis endpoint subsequent to at least one dose of study treatment.||Percent||95% Confidence Interval|Least Squares Mean
661402|NCT01841619|Primary|Skindex 29|The subjects also evaluated their skin-specific quality of life with the Skindex-29 − the questionnaire consisting of 29 items used to calculate three subscales: symptoms (pain, itch, burning, sensitivity), emotions (depression, anxiety, embarrassment, anger) and functioning (sleep, relationships with others). All assessments were repeated at all study visits. Results expressed relative to the mean initial value of all patients, taken as 100%. Each proceeding visit will be relative to the initial visit. A decrease in percentage represents improvement while an increase in percentage indicates worsening of CLE. Visits occur on a month-to-month basis.|Initial, 1st Visit - 9th Visit|||Percent of Baseline||Standard Deviation|Mean
661403|NCT01841619|Secondary|Cutaneous Lupus Erythematosus Disease Area and Severity Index - Total Damage Score (CLASI - TDS)|"Disease activity will be measured using the CLASI activity score that describes the damage of the disease. This score ranges from 0-70, with higher scores indicating more severe skin disease. This clinical assessment tool enables standardized assessments of response to therapy.
Results expressed relative to the mean initial value of all patients, taken as 100%. Each proceeding visit will be relative to the initial visit. A decrease in percentage represents improvement while an increase in percentage indicates worsening of CLE. Visits occur on a month-to-month basis.
All patients were measured identically in all visits."|Initial, 1st Visit - 9th Visit|||Percent of Baseline||Standard Deviation|Mean
661404|NCT01841619|Primary|Cutaneous Lupus Erythematosus Disease Area and Severity Index - Total Activity Score (CLASI - TAS)|"Disease activity will be measured using the CLASI activity score that describes the activity of the disease. This score ranges from 0-70, with higher scores indicating more severe skin disease. This clinical assessment tool enables standardized assessments of response to therapy.
Results expressed relative to the mean initial value of all patients, taken as 100%. Each proceeding visit will be relative to the initial visit. A decrease in percentage represents improvement while an increase in percentage indicates worsening of CLE. Visits occur on a month-to-month basis."|Initial, 1st Visit - 9th Visit|||Percent of Baseline||Standard Deviation|Mean
661405|NCT01841619|Secondary|Mean Percent Change in Physician's Subjective Assessment of Severity (PSAS)|"At clinic visits, the investigator will categorize the change in disease activity in each patient as improved, unchanged, or worse since the last visit. Estimated change in disease activity will be based on the investigator's subjective assessment of the patient's skin disease.
Results expressed relative to the mean initial value of all patients, taken as 100%. Each proceeding visit will be relative to the initial visit. A decrease in percentage represents improvement while an increase in percentage indicates worsening of CLE. Visits occur on a month-to-month basis."|Initial, 1st Visit - 9th Visit|||Percent of Baseline||Standard Deviation|Mean
661406|NCT01841619|Secondary|Mean Percent Change in Physician's Subjective Assessment of Improvement (PSAI)|"At clinic visits, the investigator will categorize the change in disease activity in each patient as improved, unchanged, or worse since the last visit. Estimated change in disease activity will be based on the investigator's subjective assessment of the patient's skin disease.
Results expressed relative to the mean initial value of all patients, taken as 100%. Each proceeding visit will be relative to the initial visit. A decrease in percentage represents improvement while an increase in percentage indicates worsening of CLE. Visits occur on a month-to-month basis."|Initial, 1st Visit - 9th Visit|||Percent of Baseline||Standard Deviation|Mean
661407|NCT01841593|Primary|Amlodipine AUC(0-24h)|AUC0-24h: Area under the concentration time curve 24 hours in the absence, and presence, of raltegravir|Post-dose on day 7 of daily dosing|||ng*h/mL||95% Confidence Interval|Geometric Mean
661408|NCT01841593|Primary|Raltegravir AUC(0-12h )|AUC0-12h: Area under the concentration time curve over 12 hours in the absence, and presence, of amlodipine.|Post dose after day 7 of daily dosing|||ng*h/mL||95% Confidence Interval|Geometric Mean
661409|NCT01841593|Primary|Amlodipine C24h|measured concentration 24 hours after dose in the absence, and presence, of raltegravir|12 hours post-dose on day 7 of daily dosing.|||ng/mL||95% Confidence Interval|Geometric Mean
661410|NCT01841593|Primary|Raltegravir C12h|measured concentration 12 hours after dose in the absence, and presence, of amlodipine.|12 hours post-dose on day 7 of daily dosing.|||ng/mL||95% Confidence Interval|Geometric Mean
661411|NCT01841593|Primary|Maximum Observed Concentration (Cmax) of Raltegravir and Amlodipine Without and With Co-administration of the Other Studied Drug.|"To investigate the pharmacokinetics of raltegravir and amlodipine co-administration. The pharmacokinetic parameters calculated for raltegravir and amlodipine will be trough concentration (Ctrough), defined as the concentration at 24 hours after the observed drug dose, the maximum observed plasma concentration (Cmax), elimination half-life (t1/2), time point at Cmax (Tmax), and total drug exposure, expressed as the area under the plasma concentration–time curve from 0–24 hours after dosing (AUC0–24h).
All pharmacokinetic parameters will be calculated using non-compartmental modeling techniques (WinNonlin®) and all statistical calculations performed and analyzed using SAS version 9.1 or SPSS V17.0."|Day 7 of each intervention (0 (pre-dose), 2, 4, 8 and 12 hours post dose (both drugs) and 24 hours post dose (amlodipine only))|Data from all enrolled participants who participated in at least two of the three PK assessments were included in the analysis.||ng/mL||95% Confidence Interval|Geometric Mean
661412|NCT01841567|Secondary|Overall Cost Regarding Dressing Wear Time||7 days||||||
661417|NCT01841216|Secondary|Perceived Exertion|Thera-Band(R) RISE (Resistance Intensity Scale for Exercise) Scale to measure amount of perceived exertion during resistance band exercises. This is a scale 0 to 10, 0 being extremely easy and 10 being extremely hard. The subject rated the intensity or resistance felt on each exercise on this scale. The ideal range for an exercise is in the middle of the scale (4-7) where the subject is feeling resistance but is not maximally exerted.|16 exercises during one 40 minute session|||units on a scale||Full Range|Mean
661418|NCT01841216|Primary|Percent of Maximal Voluntary Isometric Contraction (%MVIC)|Percent of Maximal Voluntary Isometric Contraction was measured by placing EMG leads on selected muscles. Data was collected and analyzed with the MyoResearch XP Masters Edition (Noraxam Inc., Scottsdale, AZ). The EMG signals were smoothed and rectified and analyzed using a root-mean-square algorithm. We used visual onset and offset of the EMG signal amplitude to select the middle 3 of 5 trials. The middle three repetitions were analyzed. Average activation and peak activation were determined and then compared to the maximum voluntary isometric contraction (MVIC), captured during a manual muscle test, for each muscle group, and expressed as a %MVIC. The %MVIC can be greater than 100% since the MVIC is captured in a stationary, isometric position using manual force and all other activities are performed in motion against elastic or gravity resistance.|One 40 minute session|||percentage of MVIC of gmax||Standard Deviation|Mean
661419|NCT01841021|Secondary|Number of Participants With Study Related Serious Adverse Events (SAEs)|Serious adverse events (SAEs) to be summarized by worst NCI NCI Common Terminology Criteria for Adverse Events (CTCAE) grade.|Up to 24 months post treatment|All participants.||Participants|||Count of Participants
661420|NCT01841021|Secondary|Overall Survival (OS)|Investigators intended to report median time and its 95% confidence interval estimate using the Kaplan-Meier method, for 20 participants. Radiological assessments to be discontinued at the time of tumor progression or initiation of new anticancer therapy, after which survival to be evaluated every 3 months until 2 years from the start of study treatment or until study closure.|24 months post treatment or until study closure|Participants evaluable at 24 months post treatment or at study closure.|||||
661421|NCT01841021|Secondary|Progression Free Survival (PFS)|Investigators intended to report median time and its 95% confidence interval estimate using the Kaplan-Meier method, for 20 participants. Stable disease (SD) defined according to the modified 2007 International Working Group (IWG) response criteria for non-Hodgkin lymphomas (NHL).|24 months post treatment|Participants evaluable at 24 months post treatment.|||||
661422|NCT01841021|Secondary|Time to Disease Progression (TTP)|Investigators intended to report median time and its 95% confidence interval estimate using the Kaplan-Meier method, for 20 participants. Progressive disease (PD) defined according to the modified 2007 International Working Group (IWG) response criteria for non-Hodgkin lymphomas (NHL).|Up to 24 months post treatment|All participants.||months|||Number
661423|NCT01841021|Secondary|Duration of Response (DOR)|DOR: The number of days between the first tumor response assessment of objective response (complete response and partial response) to the time of the first tumor response assessment of progressive disease (PD) or death if due to disease progression (date of first PD assessment or death due to disease progression-date of first objective response assessment +1).|Up to 24 months post treatment|Participants with Complete Response or Partial Response.|||||
661424|NCT01841021|Secondary|Time to Response (TTR)|Investigators intended to report median time and its 95% confidence interval estimate using the Kaplan-Meier method, for 20 participants. TTR: The time from the start of treatment to the first time when the measurement criteria for CR or PR are met. Participants who did not have a confirmed response to be censored at the date of the last tumor assessment.|Up to 24 months post treatment|Participants with Complete Response or Partial Response.|||||
661425|NCT01841021|Primary|Overall Response Rate (ORR)|ORR: The proportion of patients with complete response (CR) and partial response (PR). Follow-up assessments after cycle 16 to be done every 12 weeks for up to 24 months. Restaging imaging computed tomography (CT) scans to be repeated 12 and 24 months from the beginning of the follow-up period. Objective disease response (CR and PR) defined according to the modified 2007 International Working Group (IWG) response criteria for non-Hodgkin lymphomas (NHL). CR = Disappearance of all evidence of disease; PR = Regression of measurable disease and no new sites.|Up to 24 months post treatment|All participants.||Participants|||Count of Participants
661426|NCT01840943|Secondary|Number of Participants With Adverse Events|An AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Grade 3 (Severe) events are symptoms causing inability to perform usual social & functional activities. Grade 4 (Life-threatening) events are Symptoms causing inability to perform basic self-care functions or Medical or operative intervention indicated to prevent permanent impairment, persistent disability, or death.|Up to 30 days after the last dose of study medication|Safety population included all randomized participants.||participants|||Number
661427|NCT01840943|Secondary|Apparent Volume of Distribution of Plasma Concentration of CAELYX||0 hour, 30 minutes, 90 minutes, 2 hours, 4 hours, 8 hours, 12 hours, Day 2, Day 3, Day 5, Day 8, and Day 11 for Cycle 1 and Cycle 2|Data was not collected for this outcome measure as the study was early terminated.|||||
661428|NCT01840943|Secondary|Systemic Clearance of Plasma Concentration of CAELYX||0 hour, 30 minutes, 90 minutes, 2 hours, 4 hours, 8 hours, 12 hours, Day 2, Day 3, Day 5, Day 8, and Day 11 for Cycle 1 and Cycle 2|Data was not collected for this outcome measure as the study was early terminated.|||||
661429|NCT01840943|Secondary|Apparent Terminal Elimination Rate Constant of Plasma Concentration of CAELYX||0 hour, 30 minutes, 90 minutes, 2 hours, 4 hours, 8 hours, 12 hours, Day 2, Day 3, Day 5, Day 8, and Day 11 for Cycle 1 and Cycle 2|Data was not collected for this outcome measure as the study was early terminated.|||||
661430|NCT01840943|Secondary|Apparent Terminal Elimination Half-life of Plasma Concentration of CAELYX||0 hour, 30 minutes, 90 minutes, 2 hours, 4 hours, 8 hours, 12 hours, Day 2, Day 3, Day 5, Day 8, and Day 11 for Cycle 1 and Cycle 2|Data was not collected for this outcome measure as the study was early terminated.|||||
661431|NCT01840943|Secondary|Area Under the Plasma Concentration of CAELYX||0 hour, 30 minutes, 90 minutes, 2 hours, 4 hours, 8 hours, 12 hours, Day 2, Day 3, Day 5, Day 8, and Day 11 for Cycle 1 and Cycle 2|Data was not collected for this outcome measure as the study was early terminated.|||||
661434|NCT01840943|Secondary|Number of Participants With Overall Survival|Number of Participants With Overall survival were categorized as number of 1) Deaths, 2) Still alive, 3) Early termination from the study due to lost to follow up, 4) Early termination from the study due to withdraw of consent, 5) Other. Overall survival is defined as the time interval from randomization to death from any cause.|Week 4 after the last dose of the study medication and approximately up to 1 year after the disease progression or completion of the study treatment or death, whichever is earlier|The mITT population included all randomized participants.||participants|||Number
661435|NCT01840943|Secondary|Health-related Quality of Life Assessment (HQL)|Calculation of each HQL domain scale will be performed according to the scoring guidelines for each of the HQL measures. The HQL analyses will include scales measuring physical functioning, pain, nausea, fatigue, and global quality of life. Each item is measured on a scale of 0 to 3, where 0 = no impact on quality of life and 3 = extreme impact on quality of life.|Day 1 of each cycle of study medication and Week 4 after last dose of study medication|Data was not collected for this outcome measure as the study was early terminated.|||||
661436|NCT01840943|Secondary|Duration of Response|It is calculated as the first observation of a durable response (the first of the 2 confirmatory measurements) to the first observation of disease progression or death due to any cause.|Up to 1 year of last dose (Week 24) administration|The mITT population included all randomized participants. Duration of response was analyzed for participants who achieved response.||weeks||95% Confidence Interval|Median
661437|NCT01840943|Secondary|Time to Response|It is calculated as the day of randomization to the first observation of a durable response (the first of the 2 confirmatory measurements).|Up to Week 24|The mITT population included all randomized participants.Time to response was analyzed for participants who achieved response.||weeks||Full Range|Median
661438|NCT01840943|Secondary|Number of Participants With Response|Response rate was measured as number of participants with at least a durable response: Complete response (CR) or partial response (PR). Complete response is defined as the disappearance of all target lesions. Partial response is defined as at least a 30 percentage decrease in the sum of diameters of target lesions. Stable disease defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Progression in disease is defined as at least a 20% increase in the sum of diameters of target lesions. Not evaluable participants were those who were not analyzed. The reference of the baseline sum of diameters of lesions was considered.|Up to Week 24|The mITT population included all randomized participants.||participants|||Number
661439|NCT01840943|Secondary|Duration of Progression-free Survival|It was calculated as the time, in weeks, from the day of randomization until documented disease progression or death due to any cause, whichever occurs first using a Kaplan-Meier curve for PFS.|1 year after the last dose (24 weeks) administration|The mITT population included all randomized participants.||weeks||95% Confidence Interval|Median
661440|NCT01840943|Primary|Number of Participants With Progression-free Survival Incidence at Week 24|Progression-free survival incidence was be measured as number of participants who were progression-free and alive. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20 percent (%) increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Week 24|The modified intent-to-treat population included (mITT) included all randomized participants.||participants|||Number
661441|NCT01840605|Secondary|Patient Impression of Pruritus||2 ｗeeks||||||
661442|NCT01840605|Secondary|Severity of Atopic Dermatitis||2 ｗeeks||||||
661443|NCT01840605|Secondary|Pruritus Score||2 ｗeeks||||||
661444|NCT01840605|Primary|Change From Baseline in Pruritus Score|The pruritus symptoms score were rated on 5-point scale ranging from 0 (none) to 4 (severe).|2 weeks|||units on a scale||Standard Error|Least Squares Mean
661445|NCT01840410|Secondary|Number of Primary Reasons for Decision to Treat by Investigator|The total number of primary reasons for decisions to treat was assessed. A single participant could have had multiple primary reasons for treatment.|Month 12|Safety set: The safety set included randomized participants who received at least one dose of study treatment and was based on the actual treatment received.||Number of primary reasons|Participants||Number
661446|NCT01840410|Secondary|Number of Participants With Re-treatments|The number of participants, administered re-treatments according to treatment frequency, was assessed. Re-treatment was defined as an administration of study medication following at least one non-missed visit where treatment was not administered in the study eye. Up to month 12, the maximum number of retreatments was 5.|Month 12|Safety set: The safety set included randomized participants who received at least one dose of study treatment and was based on the actual treatment received.||Paticipants|||Number
661447|NCT01840410|Secondary|Number of Participants With Ranibizumab Treatments in Study Eye|The number of participants administered study treatments, according to treatment frequency, was assessed.|Month 12|Safety set: The safety set included randomized participants who received at least one dose of study treatment and was based on the actual treatment received.||Participants|||Number
661448|NCT01840410|Secondary|Number of Participants With Requirement for Rescue Treatment at Month 1|Rescue treatment with laser photocoagulation or periocular treatment could be administered at Month 1 only if the participant had a visual acuity loss of > 5 letters due to disease activity from baseline to Month 1.|Month 1|The full analysis set (FAS) was considered for the analysis. The FAS included all participants who were randomized to treatment. Only participants, with available data at Month 1, were analyzed.||Participants|||Number
661449|NCT01840410|Secondary|Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss|VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using ETDRS-like visual acuity testing charts at a testing distance of 4 meters.|Month 2, Month 6, Month 12|The full analysis set (FAS) was considered for the analysis. The FAS included all participants who were randomized to treatment. Only participants, with available data at both baseline and the given post-baseline time point, were analyzed for that post-baseline time point.||Participants|||Number
661490|NCT01838785|Secondary|The Test/Retest 18F-DTBZ PET Measurements of VMAT2 Binding in Healthy Subjects.||two years|A subgroup of 5 subjects receive additional scan for a test/retest reliability study||SUVR||80% Confidence Interval|Mean
661491|NCT01838785|Primary|Age-Dependent Change in Striatal 18F-DTBZ Uptake of Healthy Subjects.||two years|||SUVR||95% Confidence Interval|Mean
661450|NCT01840410|Secondary|Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters|VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using ETDRS-like visual acuity testing charts at a testing distance of 4 meters.|Month 2, Month 6, Month 12|The full analysis set (FAS) was considered for the analysis. The FAS included all participants who were randomized to treatment. Only participants, with available data at both baseline and the given post-baseline time point, were analyzed for that post-baseline time point.||Participants|||Number
661451|NCT01840410|Secondary|Average Change From Baseline in BCVA|BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. BCVA was assessed at each month from Month 1 through Month 6 or at each month from Month 1 through month 12, and the data were averaged. The outcome measure is reporting the change between baseline and average BCVA from Month 1 through Month 6 or from Month 1 through Month 12 (average BCVA - baseline BCVA). A positive change from baseline indicated improvement.|Baseline (BL), Month 1 through Month 6, Month 1 through Month 12|The full analysis set (FAS) was considered for the analysis. The FAS included all participants who were randomized to treatment. Only participants, with available data at both baseline and the given post-baseline time point, were analyzed for that post-baseline time point.||letters||Standard Deviation|Mean
661452|NCT01840410|Secondary|Number of Participants With Presence of Active Chorioretinal Leakage|The presence of active chorioretinal leakage was assessed by photography imaging, i.e. fluorescein angiography (FA).|Baseline, Month 2, Month 6, Month 12|The full analysis set (FAS) was considered for the analysis. The FAS included all participants who were randomized to treatment. Only participants, with available data at both baseline and the given post-baseline time point, were analyzed for that post-baseline time point.||Participants|||Number
661453|NCT01840410|Secondary|Number of Participants With Presence of Subretinal Fluid in Study Eye Compared to Baseline|Presence of subretinal fluid in study eye compared to baseline|Baseline, Month 2, Month 6, Month 12|The FAS was considered for the analysis. The FAS included all randomized participants who received at least one dose of study treatment. Only participants (n), with values 'Absent' or 'Definite' for both the baseline and corresponding post-baseline time point, were included in the analysis.||Participants|||Number
661454|NCT01840410|Secondary|Number of Participants With Presence of Intra-retinal Fluid in Study Eye Compared to Baseline|The presence of intra-retinal fluid was assessed by OCT.|Baseline, Month 2, Month 6, Month 12|The FAS was considered for the analysis. The FAS included all randomized participants who received at least one dose of study treatment. Only participants (n), with values 'Absent' or 'Definite' for both the baseline and corresponding post-baseline time point, were included in the analysis.||Participants|||Number
661455|NCT01840410|Secondary|Change From Baseline in Central Subfield Volume (CSFV) in Study Eye|CSFV was assessed OCT. A negative change from baseline indicates improvement.|Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12|The full analysis set (FAS) was considered for the analysis. The FAS included all participants who were randomized to treatment. Only participants, with available data at both baseline and the given post-baseline time point, were analyzed for that post-baseline time point.||microliter (ul)||Standard Deviation|Mean
661456|NCT01840410|Secondary|Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye|CSFT was assessed by optical coherence tomography (OCT). A negative change from baseline indicates improvement.|Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12|The full analysis set (FAS) was considered for the analysis. The FAS included all participants who were randomized to treatment. Only participants, with available data at both baseline and the given post-baseline time point, were analyzed for that post-baseline time point.||micrometer (um)||Standard Deviation|Mean
661457|NCT01840410|Secondary|Change From Baseline in BCVA in Study Eye up to Month 2|BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. The data were analyzed using analysis of covariance (ANCOVA) model which contained the type of underlying pathophysiologic mechanism (angloid streaks versus others) and treatment group as fixed effect factors, centered baseline BCVA as a continuous covariate. A positive change from baseline indicated improvement.|Baseline, Month 1, Month 2|The full analysis set (FAS) was considered for the analysis. The FAS included all participants who were randomized to treatment. Only participants, with available data at both baseline and the given post-baseline time point, were analyzed for that post-baseline time point.||letters||Standard Error|Least Squares Mean
661458|NCT01840410|Primary|Change From Baseline in Best-corrected Visual Acuity (BCVA) in Study Eye to Month 2|BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. The data were analyzed using mixed model repeated measures (MMRM) which contained scheduled visit, the type of underlying pathophysiologic mechanism (angloid streaks versus others) and treatment group as fixed effect factors, centered baseline BCVA as a continuous covariate and treatment group by visit and visit by centered baseline BCVA interactions. A positive change from baseline indicated improvement.|Baseline, Month 2|The full analysis set (FAS) was considered for the analysis. The FAS included all participants who were randomized to treatment. Only participants, with available data at both baseline and Month 2, were analyzed.||letters||Standard Error|Least Squares Mean
661459|NCT01840319|Primary|Percentage of Participants With Survival at 30 Days After Last Dose of Tigecycline|Survival analysis was calculated using Kaplan-Meier Method. The survival status of participants from the initial study database were collected for survival analysis, if participants did not have the data in the database, the participating clinician requested the vital status information from the center for epidemiology and population health research (CESP). The deceased participants’ data were collected and the informed consent form was sent to surviving participants. The existing and the collected survival data were then merged and updated. A survival analysis was performed including a variable treatment period plus 30 follow-up days. The maximum treatment duration observed in the initial study was 78 days. Percentage of participants who were alive at 30 days after last dose (corresponding to Day 108 after first dose of tigecycline) of tigecycline were reported.|30 days after last dose of Tigecycline (Day 108)|Intent-to-treat (ITT) population included all participants of the initial study 3074A1-4448 (B1811030) (NCT00799591).||percentage of participants||95% Confidence Interval|Number
661460|NCT01840072|Secondary|Quality of Life|Due to limited funding, quality of life data were not collected.|3 months||||||
661461|NCT01840072|Secondary|Cognitive Function (Montreal Cognitive Assessment)|Cognitive function was measured by Montreal Cognitive Assessment at 3 months after randomization. The MoCA is a 30-item test that evaluates the following seven cognitive domains: visuospatial/executive functions, naming, memory, attention, language, abstraction, and orientation. One point is added for participants with education <12 years. Scores on the MoCA range from 0 to 30 and cognitive impairment was defined as a score of <26.|Three months|In a pre-planned ancillary study, 660 participants were systemically selected prior to randomization for cognitive function assessment. At the 3-month visit, 15 patients were lost to follow-up and 7 patients were deceased. A total of 638 participants who completed the cognitive function tests were included in this analysis.||MoCA score||Inter-Quartile Range|Median
661462|NCT01840072|Secondary|Cognitive Function (the Mini-Mental State Examination)|Cognitive function was measured by the Mini-Mental State Examination at 3 months after randomization. The MMSE contains 20 items that test cognitive performance in domains including orientation, registration, attention and calculation, recall, language, and visual construction. MMSE scores were divided into three ordinal categories: 24–30 (no cognitive impairment), 19–23 (mild cognitive impairment), and 0–17 (severe cognitive impairment).|Three months|In a pre-planned ancillary study, 660 participants were systemically selected prior to randomization for cognitive function assessment. At the 3-month visit, 15 patients were lost to follow-up and 7 patients were deceased. A total of 638 participants who completed the cognitive function tests were included in this analysis.||MMSE score||Inter-Quartile Range|Median
661463|NCT01840072|Secondary|Long-term Neurological and Functional Status|Those patients who were still alive at hospital discharge were contacted by telephone to set up a follow-up clinical visit. Neurological function was assessed by the modified Rankin scale at the 3-month post-treatment follow-up visit. Scores on the modified Rankin Scale range from 0 to 6, with a score of 0 indicating no symptoms; a score of 5 indicating severe disability (ie, bedridden, incontinent, or requiring constant nursing care and attention); and a score of 6 indicating death. Major disability was defined as a score of 3 to 5 on the modified Rankin Scale.|Three months|Those patients who are still alive and followed at 3-Month posttreatment follow-up visit||Score on modified Rankin scale||Inter-Quartile Range|Median
661464|NCT01840072|Secondary|Other Vascular Events|Those patients who are still alive at hospital discharge will be contacted by telephone to set up a follow-up clinical visit. Information of vascular events, such as myocardial infarction, will be collected.|3 months|||participants|||Number
661465|NCT01840072|Secondary|Recurrent Stroke|Those patients who are still alive at hospital discharge will be contacted by telephone to set up a follow-up clinical visit. Information of recurrent stroke will be collected.|3 months|||participants|||Number
661466|NCT01840072|Secondary|Mortality|Those patients who are still alive at hospital discharge will be contacted by telephone to set up a follow-up clinical visit. Information on clinical deaths will be obtained.|3 months|All participants followed at 3-month posttreatment follow-up visit||participants|||Number
661467|NCT01840072|Secondary|A Combination of All-cause Mortality and Major Disability at the 3-month Post-treatment Follow-up.|Major disability was defined as a score of 3 to 5 on the modified Rankin Scale at 3 months after randomization. Scores on the modified Rankin Scale range from 0 to 6, with a score of 0 indicating no symptoms; a score of 5 indicating severe disability (ie, bedridden, incontinent, or requiring constant nursing care and attention); and a score of 6 indicating death|3 months|All participants examined at 3-month posttreatment follow-up visit||Participants|||Count of Participants
661468|NCT01840072|Primary|A Combination of Death Within 14 Days After Randomization and Major Disability at 14 Days or at Hospital Discharge if Earlier Than 14 Days.|Major disability was defined as a score of 3 to 5 on the modified Rankin Scale at 14 days after randomization. Scores on the modified Rankin Scale range from 0 to 6, with a score of 0 indicating no symptoms; a score of 5 indicating severe disability (ie, bedridden, incontinent, or requiring constant nursing care and attention); and a score of 6 indicating death.|2 weeks|||participants|||Number
661469|NCT01839695|Primary|Primary Effectiveness Observation|Treatment success which is defined as technical success (successful delivery and deployment of the stent graft in the planned location with no unintentional coverage of other vessels, assessed intraoperatively, and the removal of the delivery system) and successful exclusion of the aneurysm while maintaining patency of the MSG and BSG at the 30 day visit.|1 month|Based on the number of ITT subject with evaluable data, subjects were considered unevaluable for treatment success if the 30 day imaging was unable to assess patency of the MSG and BSG. One subject completed CT imaging at discharge, which was not repeated at the 30 day visit, and, therefore, was not considered evaluable for this assessment.||participants|||Number
661470|NCT01839695|Primary|Primary Safety Observation - Rate of Major Adverse Events (MAEs)|Major Adverse Events is a composite endpoint that includes Aneurysm Related Mortality (ARM), Stroke, Paraplegia, and Left Arm/Hand Ischemia.|1 month|Includes active subjects in the ITT population at 30 days post-index procedure.||participants|||Number
661471|NCT01839604|Secondary|Evaluation of Pharmacokinetics (PK) of AZD9150 (Following Single Administrations in Patients With HCC) by Determining Tmax, Using the Plasma Concentration Data.|8 times (pre-dose, 1.5, 3, 3.5, 4, 6, 8, 24 hours post-dose) on Day1 of Cycle1. For additional 6 patients in Japan, 8 times (pre-dose, 1.5, 3, 3.5, 4, 6, 8, 24 hours post-dose) on Day1 of Cycle1.|8 times of PK sampling on Day1 of Cycle1. Additional 6 patients in Japan; 8 times of PK sampling on Day 1 of Cycle 1.|PK: All dosed patients with reportable AZD9150 plasma concentrations and no important adverse events or protocol deviations that may impact PK||h||Full Range|Median
661472|NCT01839604|Secondary|Preliminary Assessment of the Anti-tumour Activity of AZD9150 by Evaluation of Tumour Response.|Tumour response assessment by modified Response Evaluation Criteria in Solid Tumours (RECIST). Overall tumour response: assessed by mRECIST for HCC overall visit response of CR (disappearance of baseline TLs and NTLs), PR (>=30% decrease in sum of TLs), SD (neither PR nor PD), PD (sum TLs increased >20%), or NE .|Every 6 weeks, assessed up to 12 months.|Evaluable for response: Dosed patients with measurable disease at baseline||participants with Partial Response|||Number
661492|NCT01838694|Primary|Change From Baseline Serum Interleukin 6 (IL-6) Levels at the End of Active Dosing, Comparing Treatment to Placebo Cohort.||4 weeks|Analysis Population reflects participants for whom adequate analyzable samples were collected||percentage change from baseline||Standard Deviation|Mean
661609|NCT01837680|Secondary|Post-prandial Blood Glucose|Mean post-prandial blood glucose in pregnancy, as defined as the sum of the average post-prandial blood glucose at each visit divided by the number of visits.|up to 41 weeks|||mg/dL||Standard Deviation|Mean
661473|NCT01839604|Secondary|Evaluation of Pharmacokinetics (PK) of AZD9150 (Following Single Administrations in Patients With HCC) by Determining Cmax, Using the Plasma Concentration Data.|8 times (pre-dose, 1.5, 3, 3.5, 4, 6, 8, 24 hours post-dose) on Day1 of Cycle1. For additional 6 patients in Japan, 8 times (pre-dose, 1.5, 3, 3.5, 4, 6, 8, 24 hours post-dose) on Day1 of Cycle1. From the multiple samples a timecourse is obtained of treatment conc in the plasma over time. From this curve the associated PK parameters e.g. Cmax are obtained. For n patients we obtain up to n parameters which can then be averaged.|8 times of PK sampling on Day1 of Cycle1. Additional 6 patients in Japan; 8 times of PK sampling on Day1 of Cycle1.|PK: All dosed patients with reportable AZD9150 plasma concentrations and no important adverse events or protocol deviations that may impact PK||ng/mL||Geometric Coefficient of Variation|Geometric Mean
661474|NCT01839604|Primary|Number of Participants With Dose Limiting Toxicities During Cycle 1|Cycle 1 was defined as 3 loading doses given on Days 1, 3, and 5 followed by 3 weekly doses given on Days 8, 15, and 22.|DLT assessment window - Cycle 1 (22 days)|Safety: All patients who received at least 1 dose of AZD9150||participants with DLT|||Number
661475|NCT01839318|Secondary|Total Wettability Score|The investigator graded lens wettability by corneal region using a scale from 0 (fully wettable) to 3 (clearly visible ring distortions in more than 1/3 of ring reflection zone). The total wettability score per eye was calculated by averaging the grade of each of the 5 corneal regions (central, superior, nasal, inferior, and temporal). One eye (right eye) contributed to the mean.|Hour 8|This analysis population includes all participants exposed to the study product with reportable values.||units on a scale||Standard Deviation|Mean
661476|NCT01839318|Primary|Pre-Lens Non-Invasive Keratograph Break Up Time (PL NIK-BUT) at 8 Hours|The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The time required for a dry spot to appear on the corneal surface after blinking is referred to as the tear film break-up time. Circular images were projected onto the contact lens using an Oculus Keratograph 5 and the tear film reflection was observed. PL NIK-BUT was recorded at the first sign of distortion. A longer tear film break-up time indicates a more stable tear film. One eye (right eye) contributed to the mean.|Hour 8|This analysis population includes all participants exposed to the study product with reportable values.||seconds||Standard Deviation|Mean
661477|NCT01839279|Secondary|Area Under the Plasma Concentration-time Curve During a Dosing Interval (AUCt) of Single Doses of 8 and 24 mg Tizanidine After Reaching Steady State.||0.5, 1, 1.5, 2, 4, 8, 12 & 24 hours post dose on Days 5 (8 mg) and 14 (24 mg)|PK Analysis set: all subjects from Group 1 who received at least one study drug and have at least one valid PK assessment||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
661478|NCT01839279|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Single Doses of 8 and 24 mg Tizanidine After Reaching Steady State.||0.5, 1, 1.5, 2, 4, 8, 12 & 24 hours post dose on Days 5 (8 mg) and 14 (24 mg)|PK Analysis set: all subjects from Group 1 who received at least one study drug and have at least one valid PK assessment||hour||Full Range|Median
661479|NCT01839279|Secondary|Maximum Plasma Concentration (Cmax) of Single Doses of 8 and 24 mg Tizanidine After Reaching Steady State.||0.5, 1, 1.5, 2, 4, 8, 12 & 24 hours post dose on Days 5 (8 mg) and 14 (24 mg)|PK Analysis set: all subjects from Group 1 who received at least one study drug and have at least one valid PK assessment||ng/mL||Geometric Coefficient of Variation|Geometric Mean
661480|NCT01839279|Secondary|Assessing the Relationship Between Changes in the QTc Interval and Plasma Levels of Tizanidine Using Concentration-effect Modeling|The relationship will be quantified using a linear mixed effects model with an intercept. Data from Day 5 and Day 14 were fitted into regression model to obtain a slope of change. The measure type 'Number' followed by (90% Confidence Interval) shown in results is the slope from the linear fit.|Day 5, Day 14|Pk/QTc Analysis set will include all subjects in the QT/QTc analysis set with at least one valid PK assessment. Effect of moxifloxacin was as expected. Therefore, no analysis required per Medical Monitor.||msec per ng/mL||90% Confidence Interval|Number
661481|NCT01839279|Secondary|The Baseline-adjusted, Placebo-corrected (ΔΔQTc) on QTc Method Not Selected as Primary Endpoint.|Change from baseline in Cardiac Repolarization (QTc Interval) at Day 5 (Tizanidine 8 mg). Moxifloxacin was not investigational drug, it was used to assess the sensitivity of the study.|Baseline and Day 5|QT/QTc Analysis set: Received at least 1 dose of study drug (including placebo), had measurements at baseline and on-treatment with at least 1 time point post-dose with at minimum triplicate measures giving rise to a QTc value for primary correction method. Effect of moxifloxacin was as expected. Therefore, no analysis required per Medical Monitor.||msec||90% Confidence Interval|Least Squares Mean
661482|NCT01839279|Primary|The Primary Endpoint Will be the Baseline-adjusted, Placebo-corrected Effect on QTc (ΔΔQTc) on Day 14.|Change from baseline in Cardiac Repolarization (QTc Interval) at Day 14 (Tizanidine 24 mg). Moxifloxacin was not investigational drug, it was used to assess the sensitivity of the study.|Baseline and Day 14|QT/QTc Analysis set: Received at least 1 dose of study drug (including placebo), had measurements at baseline and on-treatment with at least 1 time point post-dose with at minimum triplicate measures giving rise to a QTc value for primary correction method. Effect of moxifloxacin was as expected. Therefore, no analysis required per Medical Monitor.||milliseconds (msec)||90% Confidence Interval|Least Squares Mean
661483|NCT01839058|Secondary|Correlation Between Symptom Onset and Esophageal Shortening|Esophageal shortening will be defined as the point during the 20 minute acid infusion at which the lower esophageal sphincter begins to migrate proximally. A 2 minute window following this time point will then be used to determine if patients symptoms increased by > 2 on a visual analogue pain scale between 0 – 10.|20 minutes||||||
661484|NCT01839058|Secondary|Esophageal Length at Maximal Symptom Intensity|Mean length of esophagus at peak patient reported symptom intensity with acid infusion|20 minutes||||||
661485|NCT01839058|Secondary|Esophageal Length at Symptom Onset|Length of Esophagus as measured by manometry during acid infusion when patient reports symptoms|20 minutes||||||
661486|NCT01839058|Primary|Mean Change in Esophageal Length With Acid|Mean length of esophagus with acid infusion minus mean length of esophagus with saline infusion|Length at T= 20 minutes - Baseline (T=0)|||centimeters||Standard Deviation|Mean
661487|NCT01838980|Primary|Mean of All Subjects Colon Segments BBPS>=2|"Human colon has 3 segments and each segment can be scored 0 (unprepared colon) - 3 (clean colon).
Summing all colon segments BBPS score of all participants dividing in the number of segments is expected to be >=2."|Following the colonoscopic procedure- Up to 24 hours.|"15 subjects were enrolled to the study.
1 was excluded. Total of 14 subjects were analyzed."||Mean of BBPS score per segment||Standard Deviation|Mean
661493|NCT01838681|Secondary|Change From Randomisation to Week 24 in Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q (SF)) Total Score During the Randomised Treatment Period|The original Q-LES-Q is a patient self-rated scale designed to measure the degree of enjoyment and satisfaction experienced by patients in various areas of daily life. It consists of 93 items to measure: physical health, feelings, work, household duties, school, leisure time activities, social relations, and general activities. The Q-LES-Q short form (SF) contains 16 items from the general activities section. Each item is rated on a 5-point scale ranging from 1 (very poor) to 5 (very good). The total score is the sum of the first 14 items. The last two scores are stand-alone items. The total score ranges from 14 to 70.|From randomisation to end of Period B (24 weeks)|All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B.||units on a scale||Standard Error|Least Squares Mean
661494|NCT01838681|Secondary|Change From Randomisation to Week 6 in Q-LES-Q (SF) Total Score During the Randomised Treatment Period|The original Q-LES-Q is a patient self-rated scale designed to measure the degree of enjoyment and satisfaction experienced by patients in various areas of daily life. It consists of 93 items to measure: physical health, feelings, work, household duties, school, leisure time activities, social relations, and general activities. The Q-LES-Q short form (SF) contains 16 items from the general activities section. Each item is rated on a 5-point scale ranging from 1 (very poor) to 5 (very good). The total score is the sum of the first 14 items. The last two scores are stand-alone items. The total score ranges from 14 to 70.|From randomisation to week 6|All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B.||units on a scale||Standard Error|Least Squares Mean
661495|NCT01838681|Secondary|Change From Randomisation to Week 24 in CGI-S Score During the Randomised Treatment Period|The CGI-S is a 7-point scale where the clinician rates the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.|From randomisation to end of Period B (24 weeks)|All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B.||units on a scale||Standard Error|Least Squares Mean
661496|NCT01838681|Secondary|Change From Randomisation to Week 6 in CGI-S Score During the Randomised Treatment Period|The CGI-S is a 7-point scale where the clinician rates the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.|From randomisation to week 6|All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B.||units on a scale||Standard Error|Least Squares Mean
661497|NCT01838681|Secondary|Change From Randomisation to Week 24 in SDS Total Score During the Randomised Treatment Period|The SDS assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment.|From randomisation to end of Period B (24 weeks)|All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B.||units on a scale||Standard Error|Least Squares Mean
661498|NCT01838681|Secondary|Change From Randomisation to Week 6 in SDS Total Score During the Randomised Treatment Period|The SDS assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment.|From randomisation to week 6|All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B||units on a scale||Standard Error|Least Squares Mean
661499|NCT01838681|Secondary|Remission at Week 24 in the Randomised Treatment Period|Remission is defined as a MADRS total score <=10 and a >=50% decrease from randomisation in MADRS total score.|From randomisation to end of Period B (24 weeks)|All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B. Last Observation Carried Forward (LOCF).||participants|||Number
661500|NCT01838681|Secondary|Remission at Week 6 During the Randomised Treatment Period|Remission is defined as a MADRS total score <=10 and a >=50% decrease from randomisation in MADRS total score.|From randomisation to week 6|All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B. Last Observation Carried Forward (LOCF).||participants|||Number
661501|NCT01838681|Secondary|Response at Week 24 During the Randomised Treatment Period|Response is defined as a >=50% decrease from randomisation in MADRS total score.|From randomisation to end of Period B (24 weeks)|All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B. Last Observation Carried Forward (LOCF).||participants|||Number
661502|NCT01838681|Secondary|Response at Week 6 During the Randomised Treatment Period|Response is defined as a >=50% decrease from randomisation in MADRS total score.|From randomisation to week 6|All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B. Last Observation Carried Forward (LOCF).||participants|||Number
661503|NCT01838681|Secondary|Change From Randomisation to Week 24 in MADRS Total Score During the Randomised Treatment Period|The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). The MADRS total score is the sum of the 10 items.|From randomisation to end of Period B (24 weeks)|All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B.||Units on a scale||Standard Error|Least Squares Mean
661504|NCT01838681|Secondary|Change From Randomisation to Week 6 in MADRS Total Score During the Randomised Treatment Period|The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). The MADRS total score is the sum of the 10 items.|From randomisation to week 6|All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B.||units on a scale||Standard Error|Least Squares Mean
661505|NCT01838681|Secondary|Full Remission Sustained During the Randomised Treatment Period|Full remission sustained is defined as having obtained full remission and remain in remission until completion of the study. Full remission is defined as a MADRS total score ≤10 and a ≥50% decrease from randomisation in MADRS total score for at least 8 consecutive weeks during randomised treatment.|From randomisation to end of Period B (24 weeks)|All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B.||participants|||Number
661506|NCT01838681|Secondary|Time to Full Remission During the Randomised Treatment Period|The time from randomisation until full remission has been obtained. Full remission is defined as a MADRS total score ≤10 and a ≥50% decrease from randomisation in MADRS total score for at least 8 consecutive weeks during randomised treatment. The time to full remission was calculated using Kaplan-Meier Methods.|From randomisation to end of Period B (24 weeks)|All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B.||Days||95% Confidence Interval|Median
661507|NCT01838681|Secondary|Total Time in Remission During the Randomised Treatment Period|The total time the patient spends in remission during randomised treatment. Remission is defined as a MADRS total score <=10 and a >=50% decrease from randomisation in MADRS total score. Time in remission is defined as the sum of days over all periods between Period B visits where remission was obtained. The period between two visits is counted as in remission if the patient was in remission when the period started.|From randomisation to end of Period B (24 weeks)|All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B.||Number of days||Standard Deviation|Mean
661508|NCT01838681|Secondary|Full Global Score Remission During the Randomised Treatment Period|Full global score remission is defined as a Clinical Global Impression - Severity of Illness (CGI-S) score <=2 observed for at least 8 consecutive weeks during the randomised treatment period. The CGI-S is a 7-point scale where the clinician rates the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis, on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.|From randomisation to end of Period B (24 weeks)|All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B.||participants|||Number
661509|NCT01838681|Secondary|Full Functional Remission During the Randomised Treatment Period|Full functional remission is defined as a Sheehan Disability Scale (SDS) total score <=6 and all SDS domain scores <=2 observed for at least 8 consecutive weeks during the randomised treatment period. The SDS assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment.|From randomisation to end of Period B (24 weeks)|All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B.||participants|||Number
661510|NCT01838681|Primary|Full Remission During the Randomised Treatment Period|Full remission is defined as a Montomery and Åsberg Depression Rating Scale (MADRS) total score ≤10 and a ≥50% decrease from randomisation in MADRS total score for at least 8 consecutive weeks during randomized treatment. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). The MADRS total score is the sum of the 10 items.|From randomisation to end of Period B (24 weeks)|All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B.||participants|||Number
661511|NCT01838642|Secondary|Overall Survival|Overall survival is defined as the time between the first day of treatment to the day of disease progression.|up to 6 months|No participants were enrolled in the RET mutation negative group; study closed prematurely.||months||Full Range|Mean
661512|NCT01838642|Secondary|Changes in Serum Levels of MTC Tumor Markers Carcinoemybryonic Antigen (CEA) and Its Relation With Clinical Response|Responders are those subjects with a best biomarker response of complete response (CR) or partial response (PR) and who achieve a clinical response of CR or PR assessed by the following criteria. Biomarker: complete response (CR) is normalization (</= upper limit of normal (ULN)) of CTN (i.e., normal 0-2.5 mcg/L) following treatment, confirmed with a repeat CEA level at least 4 weeks apart. Partial response (PR) is a >/=50% decrease in the CEA level relative to baseline level, confirmed with a repeat CEA level at least 4 weeks apart. Clinical: complete response (CR) is an average of 0-2 formed stools per day for a period of at least 4 weeks. Partial response (PR) is a >50% decrease in the average stool frequency relative to baseline and a change in stool consistency from watery to loose (partially formed) for a period of at least 4 weeks.|Baseline to 4 weeks|None of the participants achieved a clinical response and no data were collected for this assessment. No participants were enrolled in the RET mutation negative group; study closed prematurely.|||||
661513|NCT01838642|Secondary|Objective Response to Ponatinib|Objective response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is the disappearance of all target lesions. Any pathological lymph nodes (Whether target or non-target) must have reduction in short axis to <10 mm. Partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Progressive disease (PD) is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. Stable disease (SD) is neither shrinkage to qualify for PR nor sufficient increase to qualify for PD.|up to 4 cycles of treatment with ponatinib|One participant died on study during cycle 2. No participants were enrolled in the RET mutation negative group; study closed prematurely.||participants|||Number
661525|NCT01838616|Secondary|Sleep Evaluation at the End of Treatment: Change in the Number of Awakenings|The participants were requested to answer the question: How many times did you wake up during the night? The values were calculated from the data that participants self-reported. The change from baseline in the number of times of waking up during the night in a treatment group is reported. A negative symbol indicates that there was a reduction in the number of awakenings.|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.||number of awakenings||Standard Error|Least Squares Mean
661514|NCT01838642|Secondary|Changes in Serum Levels of MTC Tumor Markers Calcitonin (CTN) and Its Relation With Clinical Response|Responders are those subjects with a best biomarker response of complete response (CR) or partial response (PR) and who achieve a clinical response of CR or PR assessed by the following criteria. Biomarker: complete response (CR) is normalization (</= upper limit of normal (ULN)) of CTN (i.e., normal <10 pg/mL) following treatment, confirmed with a repeat CTN level at least 4 weeks apart. Partial response (PR) is a >/=50% decrease in the CTN level relative to baseline level, confirmed with a repeat CTN level at least 4 weeks apart. Clinical: complete response (CR) is an average of 0-2 formed stools per day for a period of at least 4 weeks. Partial response (PR) is a >50% decrease in the average stool frequency relative to baseline and a change in stool consistency from watery to loose (partially formed) for a period of at least 4 weeks.|Baseline to 4 weeks|None of the participants achieved a clinical response and no data were collected for this assessment. No participants were enrolled in the RET mutation negative group; study closed prematurely.|||||
661515|NCT01838642|Secondary|Molecular Differences in Advanced Medullary Thyroid Cancer (MTC)|Compare the molecular profile of tumor deoxyribonucleic acid (DNA) prior to treatment with the molecular profile at the time of progression. Prior to the first dose of ponatinib and at time of progression, subjects were to undergo a biopsy of the primary tumor or any metastatic site for analysis of tumor DNA for rearranged during transfection (RET) or rat sarcoma (RAS) mutation. Progression is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) and is defined as at least a 20% decrease in the sum of diameters of target lesions, taking as reference the smallest sum on study.|Prior to the first dose of ponatinib|Although molecular profiling was to be completed prior to first dose of ponatinib and at time of progression, samples were tested on arrival only as mutational status was an eligibility requirement. No participants were enrolled in the RET mutation negative group; study closed prematurely.||participants|||Number
661516|NCT01838642|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|17 months and 19 days|No participants were enrolled in the RET mutation negative group; study closed prematurely.||participants|||Number
661517|NCT01838642|Secondary|Progression Free Survival|Progression free survival is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.|2-4 months|No participants were enrolled in the RET mutation negative group; study closed prematurely.||months||Full Range|Mean
661518|NCT01838642|Primary|Overall Response Rate.|Defined as the percentage of participants with a best response (complete response (CR) + partial response (PR)) recorded from the start of the treatment until disease progression/recurrence assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is the disappearance of all target lesions. Any pathological lymph nodes (Whether target or non-target) must have reduction in short axis to <10 mm. Partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.|2-4 months|No participants were enrolled in the RET mutation negative group; study closed prematurely.||percentage of participants|||Number
661519|NCT01838616|Secondary|Composite Event Based Comparison of Gastrointestinal Treatment Emergent Adverse Events (TEAEs) Typical for Opioids|"In this outcome measure the early gastrointestinal-related treatment emergent events (TEAEs) were evaluated. As the trial population was opioid-naïve this was considered of interest.
The composition score of reported events of Mild, moderate to severe nausea and/or Mild, moderate to severe vomiting and/or Mild, moderate to severe constipation was evaluated."|Baseline (Randomization Visit); End of Week 3 (End of Titration Period)|Safety Set (SAF).||number of events|||Number
661520|NCT01838616|Secondary|Comparison of the Number of Participants Affected by Gastrointestinal Treatment Emergent Adverse Events (TEAEs) Typical for Opioids|"In this outcome measure the number of participants affected by early gastrointestinal-related treatment emergent adverse events (TEAEs). As the trial population was opioid-naïve this was considered of interest.
The composition score from participant who reported:
Mild, moderate to severe nausea and/or Mild, moderate to severe vomiting and/or Mild, moderate to severe constipation was evaluated."|Baseline (Randomization Visit) to End of Titration Period (End of Week 3)|Safety Set (SAF).||participants|||Number
661521|NCT01838616|Secondary|Sleep Evaluation at the End of Treatment: Change in Latency (Change in the Time Taken to Fall Asleep)|The sleep evaluation questionnaire was completed by the participant. The participant was asked: How long after bedtime/lights out did you fall asleep last night [hours]? The values are for the night prior to the visits. The negative change from baseline indicates that the time to falling asleep decreased from baseline in a treatment group.|Baseline (Randomization Visit); End of Continuation Visit (Week 12)|Full Analysis Set (FAS). Last Observation carried Forward (LOCF). Number of participants taken into account for the analyses.||hours||Standard Error|Least Squares Mean
661522|NCT01838616|Secondary|Sleep Evaluation: Latency (Time Taken to Fall Asleep)|The sleep evaluation questionnaire was completed by the participant. The participant was asked: How long after bedtime/lights out did you fall asleep last night [hours]? The values are for the night prior to the Randomization Visit (Baseline) and for the night prior to the Final Evaluation Visit (12 weeks after randomization). The higher the value the longer it took to fall asleep.|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS).||hours||Standard Deviation|Mean
661523|NCT01838616|Secondary|Sleep Evaluation at the End of Treatment: Change in the Number of Hours Slept|The sleep evaluation questionnaire was completed by the participant. The answer was in response to the question: Sleep evaluation: How long did you sleep last night [hours]? The value reported is the change in the number of hours of sleep from baseline. The positive value indicates that there was an increase in the number of hours of sleep in a treatment group.|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF).||hours||Standard Error|Least Squares Mean
661524|NCT01838616|Secondary|Sleep Evaluation: Number of Hours Slept|"The participants were requested to answer the following question:
How long did you sleep last night [hours]? The values were calculated from the data that participants self-reported for the night prior to their Randomization Visit (Baseline) and for the night prior to the End of the Continuation Visit (12 weeks after randomization)."|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF).||hours||Standard Deviation|Mean
661610|NCT01837680|Secondary|Average Fasting Glucose|Mean fasting blood glucose in pregnancy, as determined by the sum of the mean fasting glucose at each visit divided by the number of visits|up to 41 weeks|||mg/dL||Standard Deviation|Mean
661526|NCT01838616|Secondary|Sleep Evaluation: Number of Awakenings|"The participants were requested to answer the following question:
How many times did you wake up during the night? The values were calculated from the data that participants self-reported for the night prior to their Randomization Visit (Baseline) and for the night prior to the End of the Continuation Visit (12 weeks after randomization)."|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.||number of awakenings||Standard Deviation|Mean
661527|NCT01838616|Secondary|Sleep Evaluation at the End of Treatment: Change in the Overall Quality of Sleep|"The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the overall quality of sleep.
The participant rated this categorically as being one of the following: excellent, good, fair or poor.
The improvement, no change or worsening is reported based on the replies scored by the participants given at their End of Continuation Visit."|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF).||participants|||Number
661528|NCT01838616|Secondary|Clinician Global Impression of Change at the End of Treatment|In the Clinician Global Impression of Change (CGIC) the clinician indicated the perceived change over the treatment period. The clinician was requested to choose one of seven categories for each participant. The Clinician rated the participants change as “very much improved,” “much improved,” “minimally improved,” “no change,” “minimally worse,” “much worse,” or “very much worse.”|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF).||participants|||Number
661529|NCT01838616|Secondary|Patient Global Impression of Change at the End of Treatment|In the Patient Global Impression of Change (PGIC) the participant indicated the perceived change over the treatment period. PGIC is a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change as “very much improved,” “much improved,” “minimally improved,” “no change,” “minimally worse,” “much worse,” or “very much worse.”|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.||participants|||Number
661530|NCT01838616|Secondary|Change in Hospital Anxiety and Depression Scale at the End of Treatment: Depression|The Hospital Anxiety and Depression Scale (HADS) is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises 14 items. Seven statements describe depression. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points. A score below 7 is not considered to indicate depression. A score of 11 or above is considered to be a case of depression. A decrease in values over time indicates that there has been an improvement. A negative change value indicates a decrease in the depression score since the start of treatment.|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last observation carried forward (LOCF). Number of participants with data available.||units on a scale||Standard Error|Least Squares Mean
661531|NCT01838616|Secondary|Hospital Anxiety and Depression Scale: Depression|The Hospital Anxiety and Depression Scale (HADS) is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises 14 items. Seven statements describe depression. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points. A score below 7 is not considered to indicate depression. A score of 11 or above is considered to be a case of depression. A decrease in values over time indicates that there has been an improvement.|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last observation carried forward (LOCF). Number of participants with data available.||units on a scale||Standard Deviation|Mean
661532|NCT01838616|Secondary|Change in Hospital Anxiety and Depression Scale at the End of Treatment: Anxiety|"The Hospital Anxiety and Depression Scale (HADS) is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises 14 items. Seven statements describe anxiety. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points. A score below 7 is not considered to indicate anxiety. A score of 11 or above is considered to be a case of anxiety.
A negative sign indicates that there has been a decrease in anxiety since the start of treatment."|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.||units on a scale||Standard Error|Least Squares Mean
661533|NCT01838616|Secondary|Hospital Anxiety and Depression Scale: Anxiety|"The Hospital Anxiety and Depression Scale (HADS) is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises 14 items. Seven statements describe anxiety. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points. A score below 7 is not considered to indicate anxiety. A score of 11 or above is considered to be a case of anxiety.
A decrease in values over the trial period indicate that there has been an improvement."|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.||units on a scale||Standard Deviation|Mean
661534|NCT01838616|Secondary|Change in EuroQol-5 (EQ-5D) Health Status Index Outcome at the End of Treatment|"The participant scored the EuroQol-5 questionnaire. The EuroQol-5 questionnaire uses a health state classification with 5 dimensions. Each dimension was assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1 (with 1 indicating full health and 0 representing dead). The higher the values (the closer the value is to 1) the better the health status in a treatment group."|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.||units on a scale||Standard Error|Least Squares Mean
661551|NCT01838590|Secondary|Percentage of Participants Experiencing On-treatment Virologic Failure|"On-treatment virologic failure was defined as
Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)"|Up to 24 weeks|Full Analysis Set||percentage of participants|||Number
661611|NCT01837680|Secondary|Time to Achieve Glycemic Control|Time (weeks) to achieve glycemic control, as defined as mean glucose <100mg/dl|up to 41 weeks|||weeks||Full Range|Median
661535|NCT01838616|Secondary|EuroQol-5 (EQ-5D) Health Status Index Outcome|"The participant scored the EuroQol-5 questionnaire. The EuroQol-5 questionnaire uses a health state classification with 5 dimensions. Each dimension was assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1 (with 1 indicating full health and 0 representing dead). The higher the values (the closer the value is to 1) the better the health status in a treatment group."|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.||units on a scale||Standard Deviation|Mean
661536|NCT01838616|Secondary|Changes in the Short Form Health Survey (SF-12) at the End of Treatment|"The Short Form Health Survey (SF-12) has several brief broad questions on 8 aspects of health (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. The physical and mental summary scores were calculated from the individual responses. A higher score indicates a better participant perceived state of health. All domains were scored on a scale from 0 (lowest level of health) to 100 (highest level of health), with 100 representing the best possible health state.
The change in the SF-12 score shows an improvement in health from baseline if the values are positive. The higher the value the greater the improvement since starting the trial."|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS), Last Observation Carried Forward (LOCF). Number of participants with data available.||units on a scale||Standard Error|Least Squares Mean
661537|NCT01838616|Secondary|Short Form Health Survey (SF-12)|The Short Form Health Survey (SF-12) has several brief broad questions on 8 aspects of health (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. The physical and mental summary scores were calculated from the individual responses. A higher score indicates a better participant perceived state of health. All domains were scored on a scale from 0 (lowest level of health) to 100 (highest level of health), with 100 representing the best possible health state.|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.||units on a scale||Standard Deviation|Mean
661538|NCT01838616|Secondary|Change in Neuropathic Pain Symptom Inventory (NPSI) Sub-scores and Overall Score Assessment at the End of Treatment|In the Neuropathic Pain Symptom Inventory (NPSI) the participant rated their symptoms of neuropathic pain. Ten pain questions were answered on an 11-point scale, from 0 (symptom not present) to 10 (symptom at its worst imaginable intensity, e.g. worst burning imaginable). The overall NPSI score was calculated by the summation of all ten responses and ranges between 0 and 1. For pain descriptions burning, pressing, paroxysmal (pain like electric shocks or stabbing), evoked (due to touch) and paresthesia (sensation that is not unpleasant) or dysesthesia (unpleasant) sub-scores are reported. The overall values reported for all participants that completed the questionnaire are shown. A symptom was absent if the value is 0, the symptom was present in all participants and all participants rated it at its worst possible intensity if a value is 1. A negative change indicates that the intensity of the symptom has decreased since the start of treatment.|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF).||units on a scale||Standard Error|Least Squares Mean
661539|NCT01838616|Secondary|Neuropathic Pain Symptom Inventory (NPSI) Sub-scores and Overall Score Assessment|In the Neuropathic Pain Symptom Inventory (NPSI) the participant rated their symptoms of neuropathic pain. Ten pain questions were answered on an 11-point scale; from 0 (symptom not present) to 10 (symptom at its worst imaginable intensity, e.g. worst burning imaginable). The overall NPSI score was calculated by the summation of all ten responses and ranges between 0 and 1. For pain descriptions burning, pressing, paroxysmal (pain like electric shocks or stabbing), evoked (due to touch) and paresthesia (sensation that is not unpleasant) or dysesthesia (unpleasant) sub-scores are reported. The overall values reported for all participants that completed the questionnaire are shown. A symptom was absent if the value is 0, the symptom was present in all participants and all participants rated it at its worst possible intensity if a value is 1.|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.||units on a scale||Standard Deviation|Mean
661540|NCT01838616|Secondary|Change in painDETECT Final Assessment at the End of Treatment|"The painDETECT was a participant completed questionnaire. The questionnaire consists of 14 questions in four domains. Based on these questions a final assessment score was calculated. The minimum score ranged from zero to a maximum of 38. Participants with a score between 0 and 12 were scored as being negative (had no neuropathic pain component). A value between 19 and 38 was rated as being positive (neuropathic component present). Values from 13 to 18 were scored as being unclear. The theoretical range of change in this trial ranged from -38 to 15. A negative change indicated a decrease in their neuropathic component of pain."|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.||units on a scale||Standard Error|Least Squares Mean
661541|NCT01838616|Secondary|painDETECT Final Assessment|The painDETECT was a participant completed questionnaire. The questionnaire consists of 14 questions in four domains. Based on these questions a final assessment score was calculated. The minimum score ranged from zero to a maximum of 38. Participants with a score between 0 and 12 were scored as being “negative” (had no neuropathic pain component). A value between 19 and 38 was rated as being “positive” (neuropathic component present). Values from 13 to 18 were scored as being “unclear”. The theoretical range of change in this trial ranged from -38 to 15. A negative change indicated a decrease in their neuropathic component of pain.|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.||units on a scale||Standard Deviation|Mean
661552|NCT01838590|Secondary|Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set||percentage of participants|||Number
661553|NCT01838590|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 24 weeks|Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug||percentage of participants|||Number
661542|NCT01838616|Secondary|Change in Worst Pain Intensity Over the Past 24 Hours at the End of Treatment|"The recalled worst pain intensity during the last 24 hours was assessed using an 11-point Numeric rating scale, where 0 = no pain and 10 = pain as bad as you can imagine.
The participant was asked: “Please rate your pain intensity by assessing the one number that best describes your worst pain during the last 24 hours prior to the visit”.
A negative change indicates that the pain intensity decreased from the start of the trial."|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.||units on a scale||Standard Error|Least Squares Mean
661543|NCT01838616|Secondary|Worst Pain Intensity Over the Past 24 Hours|"The recalled worst pain intensity during the last 24 hours was assessed using an 11-point Numeric rating scale, where 0 = no pain and 10 = pain as bad as you can imagine.
The participant was asked: “Please rate your pain intensity by assessing the one number that best describes your worst pain during the last 24 hours prior to the visit”"|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.||units on a scale||Standard Deviation|Mean
661544|NCT01838616|Secondary|Change of Average Pain Intensity Over Three Days for Pain Radiating Towards or Into the Leg at the End of Treatment|"Typical dermatomal pain was defined as being pain that radiates beyond the knee towards the foot (sciatica) or pain evoked by stretching of the sciatic nerve.
Therefore, the participant was asked to rate their pain intensity over the past 3 days with regards to this particular pain characteristic.
The recalled average pain intensity during the last 24 hours was assessed using an 11-point Numeric rating scale, where 0 = no pain and 10 = pain as bad as you can imagine.
A negative sign indicates that there was a decrease in the average pain radiating towards or into the leg."|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.||units on a scale||Standard Error|Least Squares Mean
661545|NCT01838616|Secondary|Average Pain Intensity Over Three Days for Pain Radiating Towards or Into the Leg|"Typical dermatomal pain was defined as being pain that radiates beyond the knee towards the foot (sciatica) or pain evoked by stretching of the sciatic nerve.
The participant was asked to rate their pain intensity over the past 3 days with regards to this particular pain characteristic.
The recalled average pain intensity over the past 3 days for the pain radiating towards or into the leg was assessed by the participant using an 11-point Numeric rating scale, where 0 = no pain and 10 = pain as bad as you can imagine."|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.||units on a scale||Standard Deviation|Mean
661546|NCT01838616|Secondary|Change in Recalled Average Pain Intensity at the End of Treatment|The recalled average pain intensity score on the NRS-3 was assessed using an 11-point Numeric Rating Scale (NRS), on this scale 0 indicates no pain and 10 indicates pain as bad as you can imagine. This scale recorded the average pain intensity recalled by the participant during the previous 3 days. The participant was asked: “Please rate your pain intensity by assessing the one number that best describes your pain on average during the last 3 days (the last 72 hours prior to the visit)”. A negative sign indicates a decrease in pain from the start of treatment. The higher the absolute values, the greater the change since the start of treatment (baseline visit).|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF).||units on a scale||Standard Error|Least Squares Mean
661547|NCT01838616|Secondary|Recalled Average Pain Intensity|The recalled average pain intensity score on the NRS-3 was assessed using an 11-point Numeric Rating Scale (NRS), on this scale 0 indicates no pain and 10 indicates pain as bad as you can imagine. This scale recalls the average pain intensity during the last 3 days. The participant was asked: “Please rate your pain intensity by assessing the one number that best describes your pain on average during the last 3 days (the last 72 hours prior to the visit)”.|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF).||units on a scale||Standard Deviation|Mean
661548|NCT01838616|Primary|Change in the Patient Assessment of Constipation Symptoms (PAC-SYM) Total Score|"The Constipation Assessment (PAC-SYM) is a 12-item self-report questionnaire that assessed the severity of symptoms of constipation. Participants were asked How severe have each of these symptoms been in the last two weeks? e.g. Pain in your stomach. There are 3 subscales: 4 questions on abdominal symptoms, 3 on rectal symptoms and 5 on stool symptoms. Responses were rated on a 5-point Likert scale ranging from 0 (absence of symptom) to 4 (very severe symptoms). If the changes in the overall or subscale scores are positive then there is a worsening in symptoms associated with constipation. The change in the assessment of constipation symptoms (PAC-SYM) total score from the Randomization Visit to the Final Evaluation Visit. The PAC-SYM overall score is the sum of scores of all non-missing items divided by the number of non-missing items (if at least 6 items were non-missing)."|Baseline (Randomization Visit); End of Continuation Period (Week 12)|The primary analysis was performed for the Per Protocol Set (PPS).||units on a scale||Standard Error|Least Squares Mean
661549|NCT01838616|Primary|Change in the Average Pain Intensity Score on an 11-point Numeric Rating Scale (NRS-3)|"For this pain assessment, the participant indicated the level of average pain experienced over the previous 3 days on an 11-point Numeric Rating Scale (NRS-3) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. The value reported represents the change from the randomization visit (i.e., the last 3 days in the washout period prior to Investigational Medicinal Product initiation and titration) to the end of the continuation period (i.e., up to 9 weeks on the stable dose). The theoretical values range from -10 to 10. A negative sign indicates a decrease in pain from the start of treatment. The higher the absolute values, the greater the change since the start of treatment (Baseline Visit)."|Baseline (Randomization Visit); End of Continuation Period (Week 12)|The primary analysis was performed for the Per Protocol Set (PPS). Last Observation Carried Forward (LOCF).||units on a scale||Standard Error|Least Squares Mean
661550|NCT01838590|Secondary|Percentage of Participants Experiencing Virologic Relapse|Virologic relapse was defined as confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.|Up to Posttreatment Week 24|Full Analysis Set||percentage of participants|||Number
661577|NCT01837797|Secondary|Sustained Remission During the Randomised Treatment|Based on a pre-specified MADRS total score|From randomisation to end of treatment|Only 3 patients completed study Period 2. A total of 129 patients were enrolled when the study was terminated (Planned: 1334 patients).|||||
661554|NCT01838590|Primary|Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants with genotype 4 HCV infection who were randomized and received at least one dose of study drug||percentage of participants|||Number
661555|NCT01838499|Secondary|Change From Baseline to 12 Weeks in Numerical Assessment Scale Numerical Rating Scale for Pain|"Assessment of change in pain via Numerical Rating Scale. Daily pain is reported by the subject using an 11-point 0 (no pain) to 10 (worst pain imaginable) numeric rating scale.
Baseline score is the average of the values collected in the 7 days prior to first dose of study drug. Each Visit score is the average of the values collected in the 7 days prior to that visit."|12 weeks|FAS (LOCF)||changes in scores on a scale||Standard Error|Least Squares Mean
661556|NCT01838499|Secondary|"2) Subject’s Global Impression of Change Reported on PGIC Scale (1-7 Point Scale Ranging From 1 Very Much Improved to 7 Very Much Worse)"|"Percentage of subjects achieving a clinically significant response measured by the proportion of subjects who are minimally improved, much improved or very much improved on the Patient's Global Impression of Change (PGIC)"|12 weeks|||% of patients|||Number
661557|NCT01838499|Primary|1) Percentage of Subjects Achieving a Clinically Relevant Response in Physician Global Assessment (PGA), With Score 0,1 or 2 From Baseline to 12 Weeks|Percentage of subjects achieving a clinically significant response measured by the proportion of subjects who achieve 0, 1, or 2 PGA by the end of week 12|12 weeks|FAS||% of patients|||Number
661558|NCT01838213|Other Pre-specified|Carriage of ESBL Producing Bacteria|Culture results from patient fecal samples will be collected up to 3 years after urinary tract infection and carriage of ESBL producing bacteria will be examined.|up to 3 years||||||
661559|NCT01838213|Secondary|Subjective Outcome|A patient form will be filled in. Data about cessation of symptoms of urinary tract infection will be recorded.|14 days||||||
661560|NCT01838213|Primary|Treatment Failure|"Patients included in the study with urinary tract infection (UTI) and treated as part of normal routine were followed for 14 days and further prescriptions of antimicrobials normally used for treatment of UTI will be considered treatment failures. Only participants that received pivmecillinam are reported here. In the paper published in PlosOne High Rate of Per Oral Mecillinam Treatment Failure in Community-Acquired Urinary Tract Infections Caused by ESBL-Producing Escherichia coli the mecillinam treatment group were compared with the group that did not receive mecillinam."|14 days after initiation of treatment|Patients that did receice pivmecillinam.||Treatment success|||Number
661561|NCT01838044|Secondary|Percentage of Participants With >= 50% Reduction From Baseline in the Weekly Mean Pain NRS Score at Week 5 and Week 10|The Daily Pain diary consists of an 11-point NRS ranging from 0 (“no pain”) to 10 (“worst possible pain”). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10: Select the number that best describes your pain during the past 24 hours from 0 to10 where 0 represents no pain and 10 represents the worst possible pain.|Week 5 and Week 10|The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).||Percentage of participants|||Number
661562|NCT01838044|Secondary|Percentage of Participants With >= 30% Reduction From Baseline in the Weekly Mean Pain NRS Score at Week 5 and Week 10|The Daily Pain diary consists of an 11-point NRS ranging from 0 (“no pain”) to 10 (“worst possible pain”). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10: Select the number that best describes your pain during the past 24 hours from 0 to10 where 0 represents no pain and 10 represents the worst possible pain.|Week 5 and Week 10|The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).||Percentage of participants|||Number
661563|NCT01838044|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Sleep Disturbance Subscale at Week 5 and Week 10|The MOS-Sleep Scale is a self-administered questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. With the exception of sleep adequacy, optimal sleep, and quantity, higher scores reflect greater impairment in the MOS-Sleep subscales. Sleep Disturbance: Range=0 to 100; higher scores indicate greater sleep disturbance. Negative changes indicate improvement.|Week 5 and Week 10|The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).||Units on a scale||Standard Deviation|Mean
661564|NCT01838044|Secondary|Change From Baseline in Brief Pain Inventory Short Form (BPI sf) - Pain Severity Index Score at Week 5 and Week 10|BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during the past 24 hours. The Pain severity domain: The BPI severity domain includes pain at its ’worst,’ ’least,’ ’average,’ and ’now’ (current pain) on 0-10 NRS scales and takes the mean of these 4 items. Scores range from 0 (no pain) to 10 (pain as bad as you can imagine), therefore higher scores indicate greater pain severity.|Week 5 and Week 10|The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).||Units on a scale||Standard Deviation|Mean
661565|NCT01838044|Secondary|Percentage of Days in Mild, Moderate and Severe Pain at Period 1 and Period 2|Period 1 indicates from Visit 2 (baseline) to Visit 4 (Week 5). Period 2 indicates from Visit 4 (Week 5) to Visit 6 (Week 10). A rating of 0 is considered no pain; 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain.|Period 1 and Period 2|The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).||% of days||Standard Deviation|Mean
661566|NCT01838044|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale (HADS-D) Depression Scores at Week 5 (Visit 4) and Week 10 (Visit 6)|The HADS is a self-administered questionnaire measuring depression. Each subscale consists of 7 statements and the participants respond as to how each item applies to them on a scale of 0 to 3 (0 = No depression, to 3 = Severe feelings of depression). Separate scores are calculated for each subscale and a score (ranging from 0 to 21) is obtained for each subscale. The higher the score the more severe the depression.|Week 5 and Week 10|The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).||Units on a scale||Standard Deviation|Mean
661612|NCT01837680|Secondary|Number of Patients Obtaining Glycemic Control|Number of each group that obtains glycemic control, defined as mean glucose <100mg/dl.|up to 41 weeks|||Participants|||Count of Participants
661567|NCT01838044|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale (HADS-A) Anxiety Scores at Week 5 (Visit 4) and Week 10 (Visit 6)|The HADS is a self-administered questionnaire measuring anxiety. Each subscale consists of 7 statements and the participants respond as to how each item applies to them on a scale of 0 to 3 (0 = No anxiety, to 3 = Severe feelings of anxiety). Separate scores are calculated for each subscale and a score (ranging from 0 to 21) is obtained for each subscale. The higher the score the more severe the anxiety.|Week 5 and Week 10|The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).||Units on a scale||Standard Deviation|Mean
661568|NCT01838044|Secondary|Change From Baseline in Weekly Mean of Daily Sleep Interference Rating Scale (SIRS) Compared Between Arms at Week 5 (Visit 4) and at Week 10 (Visit 6)|"The Daily Sleep Interference Rating Scale (SIRS) consists of an 11-point NRS ranging from 0 (“pain does not interfere with sleep”) to 10 (pain completely interferes with sleep [unable to sleep due to pain]). Participants described how pain had interfered with their sleep during the past 24 hours: Select the number that best describes how your pain has interfered with your sleep during the past 24 hours on a scale from 0 to 10 where 0 represents ‘does not interfere with sleep’ and 10 represents ‘completely interferes’ which means you are unable to sleep due to pain."|Week 5 and Week 10|The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).||Units on a scale||Standard Error|Least Squares Mean
661569|NCT01838044|Secondary|Percentage of Participants With PGIC for Each Arm Compared at Week 5 (Visit 4) and at Week 10 (Visit 6)|The PGIC is a single-item, self-rated instrument that measures change in the patient’s overall status since starting study medication on a scale from 1 (very much improved) to 7 (very much worse), where lower scores indicate greater improvement. This scale was administered at Visit 4 and Visit 6.|Week 5 and Week 10|The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).||percentage of participants|||Number
661570|NCT01838044|Secondary|Patient Global Impression of Change (PGIC) Compared Between Arms at Week 5 (Visit 4) and at Week 10 (Visit 6)|The PGIC is a single-item, self-rated instrument that measures change in the patient’s overall status since starting study medication on a scale from 1 (very much improved) to 7 (very much worse), where lower scores indicate greater improvement. This scale was administered at Visit 4 and Visit 6.|Week 5 and Week 10|The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).||Units on a scale||Standard Deviation|Mean
661571|NCT01838044|Secondary|Change From Baseline in Benefit, Satisfaction, and Willingness to Continue Measure Scores Compared Between Arms at Week 5 (Visit 4) and at Week 10 (Visit 6)|The BSW consists of 3, single-item measures designed to capture the participant's perception of the effect of treatment in terms of the relative benefit, their satisfaction, and their intention or willingness to continue on therapy. The BSW was administered by the investigator or designated site personnel in the local language as a standardized interview during the follow-up visits. The BSW can potentially be self-administered; however, this method of administration has not been tested. Participants completed this questionnaire at Visit 4 and Visit 6.|Week 5 and Week 10|The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).||Percentage of participants|||Number
661572|NCT01838044|Secondary|Change From Baseline in the Weekly Mean Pain NRS Score at Week 10 (Visit 6) Compared Between the Two Study Arms|The Daily Pain diary consists of an 11-point NRS ranging from 0 (“no pain”) to 10 (“worst possible pain”). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10: Select the number that best describes your pain during the past 24 hours from 0 to10 where 0 represents no pain and 10 represents the worst possible pain.|Baseline and Week 10|The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).||Units on a scale||Standard Error|Least Squares Mean
661573|NCT01838044|Secondary|Change in the Weekly Mean Pain NRS Score in Arm B, Compared Between Week 5 (Visit 4) and Week 10 (Visit 6).|The Daily Pain diary consists of an 11-point NRS ranging from 0 (“no pain”) to 10 (“worst possible pain”). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10: Select the number that best describes your pain during the past 24 hours from 0 to10 where 0 represents no pain and 10 represents the worst possible pain.|Week 5 and Week 10|The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).||Units on a scale||Standard Error|Least Squares Mean
661574|NCT01838044|Primary|Change From Baseline in the Weekly Mean Pain Numeric Rating Scale (NRS) Score at Week 5 (ie, Visit 4) Compared Between the Two Study Arms|The Daily Pain diary consists of an 11-point NRS ranging from 0 (“no pain”) to 10 (“worst possible pain”). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10: Select the number that best describes your pain during the past 24 hours from 0 to10 where 0 represents no pain and 10 represents the worst possible pain.|Baseline and Week 5|The Full Analysis Set (FAS) that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).||Units on a scale||Standard Error|Mean
661575|NCT01837966|Primary|Anxiety Reduction|We hoped to show that lavender aroma therapy reduces preoperative anxiety in patients undergoing breast. The Trait subscale (STAI-TRAID) of the Spielberger State-Trait Anxiety Inventory was administered before and after 10 minutes of aromatherapy treatment pre-surgery. The TRAIT subscale contains 20 questions scored on a Likert scale from 1-4; item scores are summed for a total score ranging from 20 to 80, with higher scores indicating higher anxiety. Change in anxiety was calculated as the score pre-aromatherapy minus the score post-aromatherapy. Higher positive change scores indicate greater reductions in anxiety.|20 minutes before surgery (pre aromatherapy) and 10 minutes before surgery (post aromatherapy)|Analysis of STAI-TRAIT questions||units on a scale||Standard Deviation|Mean
661576|NCT01837797|Secondary|Number of Patients With Risk of Suicidality Assessed Using the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS)|The Columbia Suicide Severity Rating Scale (eC-SSRS) is a semi-structured interview developed to systematically assess suicidal ideation and behaviour of patients participating in a clinical study. The C-SSRS has 5 questions addressing suicidal ideation, 5 sub-questions assessing the intensity of ideation, and 4 questions addressing suicidal behaviour.|From randomisation to end of treatment|15 patients were enrolled to Period 2, only 3 patients completed due to study termination||participants|||Number
666033|NCT01763905|Secondary|Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
661579|NCT01837797|Secondary|Sustained Response During the Randomised Treatment|Based on a pre-specified decrease in MADRS total score|From randomisation to end of treatment|Only 3 patients completed study Period 2. A total of 129 patients were enrolled when the study was terminated (Planned: 1334 patients).|||||
661580|NCT01837797|Secondary|Response During the Randomised Treatment|Based on a pre-specified decrease in MADRS total score|From randomisation to end of treatment|Only 3 patients completed study Period 2. A total of 129 patients were enrolled when the study was terminated (Planned: 1334 patients).|||||
661581|NCT01837797|Secondary|Change From Randomisation in Social Adaptation During the Randomised Treatment|Social Adaptation Self-evaluation Scale (SASS) total score|From randomisation to end of treatment|Only 3 patients completed study Period 2. A total of 129 patients were enrolled when the study was terminated (Planned: 1334 patients).|||||
661582|NCT01837797|Secondary|Change From Randomisation in Functionality Assessed by SDS During the Randomised Treatment|Sheehan Disability Scale (SDS) total score|From randomisation to end of treatment|Only 3 patients completed study Period 2. A total of 129 patients were enrolled when the study was terminated (Planned: 1334 patients).|||||
661583|NCT01837797|Secondary|Change From Randomisation in Clinical Global Impression During the Randomised Treatment|Clinical Global Impression - Severity of illness (CGI-S) score|From randomisation to end of treatment|Only 3 patients completed study Period 2. A total of 129 patients were enrolled when the study was terminated (Planned: 1334 patients).|||||
661584|NCT01837797|Primary|Change From Randomisation in Depressive Symptoms During the Randomised Treatment|Montgomery and Aasberg Depression Rating Scale (MADRS) total score|From randomisation to end of treatment|Only 3 patients completed study Period 2. A total of 129 patients were enrolled when the study was terminated (Planned: 1334 patients).|||||
661585|NCT01837797|Secondary|Number of Adverse Events|15 patients were enrolled to Period 2; only 3 patients completed due to study termination|From randomisation to follow-up|||Adverse events|||Number
661586|NCT01837719|Secondary|T-HALF of Cobicistat|Blood samples for testing plasma concentrations were obtained at predose and at specific timepoints up to 48 hours after dosing on Days 1, 8, 15, 22, and 29. T-HALF was derived from plasma concentration versus time data.|Days 1, 8, 15, 22, and 29 (1,2, 2.5, 3, 4, 5, 6, 8, 12, and 16 hours postdose); Days 2, 9, 16, 23, and 30 (24 hours postdose)|All participants who received any study medication and had any available concentration-time data. All available derived pharmacokinetic (PK) parameter values were included in the PK data set and reported, but only those with adequate PK profiles were included in the summary statistics and statistical analysis.||Hours||Standard Deviation|Mean
661587|NCT01837719|Secondary|Area Under the Concentration Curve From Time 0 to Time of Last Quantifiable Concentration (AUC[0-T]) and Area Under the Concentration Curve From Time 0 to Infinity (AUC[INF]) of Cobicistat|Blood samples for testing plasma concentrations were obtained at predose and at specific timepoints up to 48 hours after dosing on Days 1, 8, 15, 22, and 29. AUC(0-T) and AUC(INF) were derived from plasma concentration versus time data.|Days 1, 8, 15, 22, and 29 (1,2, 2.5, 3, 4, 5, 6, 8, 12, and 16 hours postdose); Days 2, 9, 16, 23, and 30 (24 hours postdose)|All participants who received any study medication and had any available concentration-time data. All available derived pharmacokinetic (PK) parameter values were included in the PK data set and reported, but only those with adequate PK profiles were included in the summary statistics and statistical analysis. n=evaluable participants||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
661588|NCT01837719|Secondary|Time of Maximum Observed Concentration (Tmax) of Cobicistat|Blood samples for testing plasma concentrations were obtained at predose and at specific timepoints up to 48 hours after dosing on Days 1, 8, 15, 22, and 29. Tmax was derived from plasma concentration versus time data.|Days 1, 8, 15, 22, and 29 (1,2, 2.5, 3, 4, 5, 6, 8, 12, and 16 hours postdose); Days 2, 9, 16, 23, and 30 (24 hours postdose)|All participants who received any study medication and had any available concentration-time data. All available derived pharmacokinetic (PK) parameter values were included in the PK data set and reported, but only those with adequate PK profiles were included in the summary statistics and statistical analysis.||Hours||Full Range|Median
661589|NCT01837719|Secondary|Maximum Observed Plasma Concentration (Cmax) of Cobicistat|Blood samples for testing plasma concentrations were obtained at predose and at specific timepoints up to 48 hours after dosing on Days 1, 8, 15, 22, and 29. Cmax was derived from plasma concentration versus time data.|Days 1, 8, 15, 22, and 29 (1,2, 2.5, 3, 4, 5, 6, 8, 12, and 16 hours postdose); Days 2, 9, 16, 23, and 30 (24 hours postdose)|All participants who received any study medication and had any available concentration-time data. All available derived pharmacokinetic (PK) parameter values were included in the PK data set and reported, but only those with adequate PK profiles were included in the summary statistics and statistical analysis.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
661590|NCT01837719|Secondary|Apparent Terminal Half-life (T-HALF) of Atazanavir|Blood samples for testing plasma concentrations were obtained at predose and at specific timepoints up to 48 hours after dosing on Days 1, 8, 15, 22, and 29. T-HALF was derived from plasma concentration versus time data.|Days 1, 8, 15, 22, and 29 (predose and at 1, 2, 2.5, 3, 4, 5, 6, 8, 12, and 16 hours postdose); Days 2, 9, 16, 23, and 30 (24, 30, and 36 hours postdose); Days 3, 10, 17, 24, and 31 (48 hours postdose)|All participants who received any study medication and had any available concentration-time data. All available derived pharmacokinetic (PK) parameter values were included in the PK data set and reported, but only those with adequate PK profiles were included in the summary statistics and statistical analysis.||Hours||Standard Deviation|Mean
661591|NCT01837719|Secondary|Observed Concentration at 24 Hours (C24) of Atazanavir|Blood samples for plasma concentrations were obtained at predose and at specific timepoints up to 48 hours after dosing on Days 1, 8, 15, 22, and 29. C24 was derived from plasma concentration versus time data.|Days 1, 8, 15, 22, and 29 (predose and at 1, 2, 2.5, 3, 4, 5, 6, 8, 12, and 16 hours postdose); Days 2, 9, 16, 23, and 30 (24, 30, and 36 hours postdose); Days 3, 10, 17, 24, and 31 (48 hours postdose)|All participants who received any study medication and had any available concentration-time data. All available derived pharmacokinetic (PK) parameter values were included in the PK data set and reported, but only those with adequate PK profiles were included in the summary statistics and statistical analysis.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
661613|NCT01837680|Primary|Glycemic Control|Overall mean glucose value of pregnancy. This will be determined by the sum of average glucose value at each visit, divided by the number of visits.|up to 41 weeks|||mg/dL||Standard Deviation|Mean
661592|NCT01837719|Secondary|Time of Maximum Observed Concentration (Tmax) of Atazanavir|Blood samples for plasma concentrations were obtained at predose and at specific timepoints up to 48 hours after dosing on Days 1, 8, 15, 22, and 29. Tmax was derived from plasma concentration versus time data.|Days 1, 8, 15, 22, and 29 (predose and at 1, 2, 2.5, 3, 4, 5, 6, 8, 12, and 16 hours postdose); Days 2, 9, 16, 23, and 30 (24, 30, and 36 hours postdose); Days 3, 10, 17, 24, and 31 (48 hours postdose)|All participants who received any study medication and had any available concentration-time data. All available derived pharmacokinetic (PK) parameter values were included in the PK data set and reported, but only those with adequate PK profiles were included in the summary statistics and statistical analysis.||Hours||Full Range|Median
661593|NCT01837719|Secondary|Number of Participants With Out-of-range Intervals on Electrocardiogram (ECG) Findings|A 12-lead ECG was recorded at predose and 4 hours post dose at screening, Days -1, 1, 8 15, 22, 29 and study discharge. ECGs were recorded after the patient had been supine for at least 5 minutes. All ECG readings post dosing (including unscheduled) were included.|At screening; on Day -1; predose and 4 hours postdose on Days 1, 18, 15, 22, and 29; and at study discharge (Day 31)|All participants who received at least 1 dose of study medication and were evaluable.||Participants|||Number
661594|NCT01837719|Secondary|Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests|LLN=lower limit of normal; ULN=upper limit of normal; preRx=pretreatment; h=high; hpf=high power field. Abnormal criteria: Leukocytes, low (*10^3 c/uL): <0.85*preRx if preRx<LLN; <0.9*LLN if LLN≤preRx≤ULN;< 0.9*LLN if preRx=missing;<LLN if preRX>ULN. Neutrophils, low (*10^3 c/uL): <0.85*preRx if preRx<1.5; <1.5 if preRx=missing; <1.5 if preRx ≥1.5. Bilirubin, h (mg/dL): >1.1* ULN if preRx≤ULN; >1.1*ULN if preRx=missing; >1.25*preRx if preRx>ULN. Bilirubin, h (mg/dL): >1.1* ULN if preRx≤ULN; >1.1*ULN if preRx=missing; >1.25*preRx if preRx>ULN. Blood, urine, h: ≥2*preRx if preRx≥1; ≥2 if preRx <1; ≥2 if preRx=missing. RBCs/WBCs, h (hpf): ≥2 if preRx=missing ≥2 if preRx<2 ≥4 if preRx ≥2. Creatine kinase, h (U/L): >1.5*preRx if preRx>ULN; >1.5*ULN if preRx≤ULN; >1.5*ULN if preRx=missing; AST, h (U/L): >1.25* preRx if preRx>ULN; >1.25*ULN if preRx≤ULN; >1.25*ULN if preRx=missing. Lactate dehydrogenase, h (U/L): >1.25*ULN if preRx≤ULN; >1.25*ULN if preRx=missing; >1.5*preRx if preRx>ULN.|At Screening and on Days -1,4, 11, 18, and 31 (study discharge)|All participants who received at least 1 dose of study drug and had laboratory test results available.||Participants|||Number
661595|NCT01837719|Secondary|Number of Participants Who Died and With Serious Adverse Events (SAEs)|An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant who receives an investigational product and that does not necessarily have a causal relationship with this treatment. An AE can be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE is any untoward medical occurrence that at any dose results in death; is life-threatening; or requires or prolongs inpatient hospitalization.|On Day 24 or 31|All participants who received at least 1 dose of any study drug.||Participants|||Number
661596|NCT01837719|Primary|Area Under the Plasma Concentration-time Curve (AUC) From Time 0 to Time of Last Quantifiable Concentration (AUC[0-T]) and From Time 0 to Infinity (AUC[INF]) for Atazanavir|Blood samples for plasma concentrations were obtained at predose and at specific timepoints up to 48 hours after dosing on Days 1, 8, 15, 22, and 29. AUC(0-T) and AUC(INF) were derived from plasma concentration versus time data.|Days 1, 8, 15, 22, and 29 (predose and at 1, 2, 2.5, 3, 4, 5, 6, 8, 12, and 16 hours postdose); Days 2, 9, 16, 23, and 30 (24, 30, and 36 hours postdose); Days 3, 10, 17, 24, and 31 (48 hours postdose)|All participants who received any study medication and had any available concentration-time data. All available derived pharmacokinetic (PK) parameter values were included in the PK data set and reported, but only those with adequate PK profiles were included in the summary statistics and statistical analysis.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
661597|NCT01837719|Primary|Maximum Observed Plasma Concentration (Cmax) of Atazanavir|Blood samples for plasma concentrations were obtained at predose and at specific timepoints up to 48 hours after dosing on Days 1, 8, 15, 22, and 29. Cmax was derived from plasma concentration versus time data.|Days 1, 8, 15, 22, and 29 (predose and at 1, 2, 2.5, 3, 4, 5, 6, 8, 12, and 16 hours postdose); Days 2, 9, 16, 23, and 30 (24, 30, and 36 hours postdose); Days 3, 10, 17, 24, and 31 (48 hours postdose)|All participants who received any study medication and had any available concentration-time data. All available derived pharmacokinetic (PK) parameter values were included in the PK data set and reported, but only those with adequate PK profiles were included in the summary statistics and statistical analysis.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
661598|NCT01837680|Secondary|Neonatal Hypoglycemia|Number of participants with incidence of blood sugar <40mg/dl in neonate|at birth, up to 41 weeks|||Participants|||Count of Participants
661599|NCT01837680|Secondary|Polyhydramnios|Incidence of polyhydramnios (defined as amniotic fluid index (AFI)>20 or deepest vertical pocket ≥8) - data not collected|at each visit in pregnancy up to 41 weeks||||||
661600|NCT01837680|Secondary|Shoulder Dystocia|Incidence of shoulder dystocia - data not collected|at birth, up to 41 weeks||||||
661601|NCT01837680|Secondary|Birth Rate|Number of live birth rate|at birth, up to 41 weeks|||Participants|||Count of Participants
661602|NCT01837680|Secondary|Delivery Mode|method of delivery including cesarean section, vaginal delivery, or assisted vaginal delivery - data not collected|at birth, up to 41 weeks||||||
661603|NCT01837680|Secondary|Intensive Care Admissions|Number of participants with incidence of neonatal intensive care unit admissions|at birth, up to 41 weeks|||Participants|||Count of Participants
661604|NCT01837680|Secondary|Neonatal Bilirubin|Percentage of neonatal hyperbilirubinemia - data not collected|at birth, up to 41 weeks||||||
661605|NCT01837680|Secondary|Maternal Hypoglycemia|Number of participants with incidence of maternal hypoglycemia (<60mg/dl)|at delivery, up to 41 weeks|||Participants|||Count of Participants
661606|NCT01837680|Secondary|Gestational Age at Delivery|Gestational age at delivery|at delivery, up to 41 weeks|||weeks||Inter-Quartile Range|Median
661607|NCT01837680|Secondary|Neonatal Weight|Neonatal weight was estimated for occurrence of neonatal macrosomia (≥4000g birth weight) and neonatal LGA(large for gestational age)(birth weight >90th percentile for gestational age|At delivery, up to 41 weeks|||g||Inter-Quartile Range|Median
661608|NCT01837680|Secondary|Weight Gain|Total weight gain in pregnancy|Number of pounds gained at each visit up to 41 weeks|||lbs||Standard Deviation|Mean
661614|NCT01837550|Secondary|Communication Strategies Scale (CSS)|CSS is designed to analyze participants' behavior in various communication situations. Scoring for CSS ranges from 1 almost never to 5 almost always for subscales Verbal- and Nonverbal Strategies and conversely for Maladaptive Behaviors; indicating how frequent a specific situation or behavior occurs. Minimum score for the total scale (reported) is 0 and maximum score for the total scale is 125.|5 weeks, 6 months|||units on a scale||Standard Deviation|Mean
661615|NCT01837550|Secondary|Hospital Anxiety and Depression Scale (HADS)|The HADS contains 14 items. Responses are scored from 0 to 3 and a higher score indicates more symptoms of anxiety and depression. Minimum score for the total scale (reported) is 0 and maximum score for the total scale is 42.|5 weeks, 6 months|||units on a scale||Standard Deviation|Mean
661616|NCT01837550|Secondary|International Outcome Inventory for Hearing Aids (IOI-HA)|The IOI-HA measures hearing aid outcomes. The IOI-HA includes seven questions, measuring specific dimensions of hearing aid outcomes: daily use, benefits, remaining activity limitations, satisfaction, remaining participation restrictions, impact on the environment, and quality of life. Each question is scored from 1 to 5 (reported), where a higher score indicates a better outcome.|pre-measurement|The IOI-HA was used only at the pre-masurement point, to select descriptive data about the participants.||units on a scale||Standard Deviation|Mean
661617|NCT01837550|Primary|The Hearing Handicap Inventory for the Elderly (HHIE)|The HHIE measures the experience of hearing loss in older people by focusing on the psycosocial and emotional effects of hearing loss. Higher score reflects a higher self-reported hearing problem. Minimum score for the total scale (reported) is 0 and maximum score is 100 points.|5 weeks, 6 months|||units on a scale||Standard Deviation|Mean
661618|NCT01837537|Secondary|Mean Error (ME) +/- 1 Breath Per Minute, Max-N Sensor|The software calculates respiration rate values via the Max-N Sensor with a mean error of +/- 1 breath per minute relative to a capnography based reference. The Mean Error value estimates the mean difference in simultaneous estimates of respiration rate (the Respiration Rate calculated from the sensor and the Respiration Rate calculated from capnography). The error value estimates the mean difference in simultaneous estimates of respiration rate (the Respiration Rate calculated from the Max-N sensor minus the Respiration Rate calculated from capnography.|up to 40 minutes of continuous monitoring|90 subjects were enrolled. Out of the 90 enrolled 75 yielded valid data. The remaining 15 subjects did not meet the predetermined data criteria (such as reference was too noisy, timing of observations could not be matched, etc.)||BrPM||Standard Deviation|Mean
661619|NCT01837537|Primary|Mean Error (ME) +/- 1 Breath Per Minute, RR Sensor|The software calculates respiration rate values via Adult Respiratory Sensor with a mean error of +/- 1 breath per minute relative to a capnography based reference. The Mean Error value estimates the mean difference in simultaneous estimates of respiration rate (the Respiration Rate calculated from the sensor and the Respiration Rate calculated from capnography).|up to 40 minutes of continuous monitoring|90 subjects were enrolled. Out of the 90 enrolled 75 yielded valid data. The remaining 15 subjects did not meet the predetermined data criteria (such as reference was too noisy, timing of observations could not be matched, etc.)||BrPM (breaths per minute)||Standard Deviation|Mean
661620|NCT01837524|Other Pre-specified|Member Self-efficacy and Confidence in Food Purchasing Decisions|Will be assessed using a brief survey at baseline (scored) and re-surveyed after the intervention. Survey questions are based on similar items from other studies of health behavior interventions.|3 months||||||
661621|NCT01837524|Other Pre-specified|Cost of Grocery Shopping for Members|Receipts from a typical week's worth of grocery shopping will be collected from all participants at baseline. Then, the same process will be repeated each month during the intervention phase to see what effect participation has on costs of grocery shopping for participants (e.g. if buying more produce because shopping with dietitian - will shopping be more expensive?)|3 months||||||
661622|NCT01837524|Secondary|Nutritional Knowledge of Members|A modified version of the Parmenter-Wardle Nutrition Knowledge Questionnaire (1999, UK) has been created based on present-day guidelines and eating patterns in the Southeast U.S., and will be administered at baseline and scored, then re-administered after the intervention and re-scored to determine whether or how the score improved after the intervention with the dietitian.|3 months||||||
661623|NCT01837524|Primary|Change in Dietary Quality Scores of Members as Measured Using the 2005 Healthy Eating Index (HEI).|"The Block FFQ will be administered at baseline in order to calculate a participant's baseline HEI score, and will be re-administered after the 3 month intervention to re-calculate the post-intervention HEI score.
The numbers reported here represent the change from pre to post intervention, in the HEI scores for participants in each group
HEI scores can range from 0 to 100, with 0 representing the least overall healthy diet, and 100 representing the most overall healthy diet. There are no units associated with the HEI score. The measure was developed by the US Dept of Agriculture and complete details regarding its development can be found on their website."|3 months|||points||Standard Deviation|Mean
661624|NCT01836809|Secondary|Total Diuretic Requirement||46 Hours|Analysis not done as study was closed early due to futility of reaching enrollment goals in the Total Artificial Heart arm|||||
661625|NCT01836809|Secondary|Time to Renal Failure||46 Hours|Analysis not done as study was closed early due to futility of reaching enrollment goals in the Total Artificial Heart arm|||||
661626|NCT01836809|Secondary|Urine Output||46 Hours|Analysis not done as study was closed early due to futility of reaching enrollment goals in the Total Artificial Heart arm|||||
661627|NCT01836809|Secondary|Need for Hemodialysis/Renal Replacement Therapy||90 days|Analysis not done as study was closed early due to futility of reaching enrollment goals in the Total Artificial Heart arm|||||
661628|NCT01836809|Primary|Renal Plasma Flow||46 Hours|Analysis not done as study was closed early due to futility of reaching enrollment goals in the Total Artificial Heart arm|||||
661629|NCT01836809|Primary|Glomerular Filtration Rate||46 hours|Analysis not done as study was closed early due to futility of reaching enrollment goals in the Total Artificial Heart arm|||||
661639|NCT01836458|Secondary|Percentage of Patients PCR-corrected Cure Rate by Day 28, Day 35 & Day 42|PCR-corrected cure rate after a single dose of KAE609 by Day 28, Day 35 & Day 42. PCR-corrected cure rate accounts for failures due to reappearance of parasites that were present in the blood before treatment (i.e. recrudescent infection) but not for failures due to a post-treatment inoculation (i.e. new infection).|Day 28, Day 35 & Day 42|Pharmacodynamic Analysis Set includes all enrolled patients.||Percentage of Patients|||Number
661630|NCT01836523|Secondary|Number of Treatment-emergent Symptomatic Hypoglycaemic Episodes|This is a confirmatory secondary endpoint. Symptomatic hypoglycaemic episodes were defined as: 1) Severe according to the American Diabetes Association (ADA) classification: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. OR 2) Self-monitoring of plasma glucose value of <3.1 mmol/L, with symptoms consistent with hypoglycaemia. A treatment emergent episode is defined as an episode with onset date (or increase in severity) on or after first day of exposure to randomised treatment and up to last dose + 7 days.|Weeks 0-52|The safety analysis set included all randomised subjects exposed to at least one dose of liraglutide or placebo.||episodes|||Number
661631|NCT01836523|Primary|Change From Baseline in Total Daily Insulin Dose|Change from baseline in total daily insulin dose at week 52. Change from baseline was represented in terms of ratio to baseline for insulin dose i.e. Total daily insulin dose at week 52/total daily insulin dose at baseline. Missing values were handled by using a MMRM.|Week 0, week 52|Full analysis set. Number of subjects analysed=subjects with any post-baseline total insulin daily dose data.||ratio||Geometric Coefficient of Variation|Geometric Mean
661632|NCT01836523|Primary|Change From Baseline in Body Weight|Change from baseline in body weight at week 52. Missing values were handled by using a MMRM.|Week 0, week 52|Full analysis set. Number of subjects analysed=subjects with any post-baseline body weight data.||kg||Standard Deviation|Mean
661633|NCT01836523|Primary|Change From Baseline in HbA1c (Glycosylated Haemoglobin)|Change from baseline in HbA1c at week 52. Missing values were handled by using a mixed model for repeated measurements (MMRM).|Week 0, week 52|Full analysis set. Number of subjects analysed=subjects with any post-baseline HbA1c data.||percentage of glycosylated haemoglobin||Standard Deviation|Mean
661634|NCT01836471|Secondary|Change From Baseline in ACQ-6 Score at Week 12 Non-atopic Compared to Atopic Patients at Week 12 - Full Analysis Set|ACQ-6 consists of:5 items on symptoms, 1 item on rescue bronchodilator use, and 1 item on airway caliber (FEV1 % predicted). The ACQ was fully validated, including a minimal important difference (MID) or smallest change that could be considered clinically important (0.5). The ACQ was self-administered at the clinic and patients scored each item on a 7-point response scale: 0 = ‘totally controlled’ and 6 = ‘severely uncontrolled.’ Study staff scored question 7 based on % predicted FEV1 (ideally pre-bronchodilator). The total score=average of first 6 questions. Baseline=the ACQ-6 measurement taken prior to first dose of randomized study drug. The single missing score was interpolated by utilizing prior or subsequent completions of the questionnaire. Estimates were from a mixed effects model with treatment, subject population (non-atopic vs. atopic), treatment by subject population interaction, baseline ACQ-6 and region as fixed effects and center nested within region as random effects.|baseline,12 weeks|||score||Standard Error|Least Squares Mean
661635|NCT01836471|Secondary|Change From Baseline in ACQ-6 Score at Week 12 Non-atopic and Atopic Patients at Week 12 - Full Analysis Set|ACQ-6 consists of:5 items on symptoms, 1 item on rescue bronchodilator use, and 1 item on airway caliber (FEV1 % predicted). The ACQ was fully validated, including a minimal important difference (MID) or smallest change that could be considered clinically important (0.5). The ACQ was self-administered at the clinic and patients scored each item on a 7-point response scale: 0 = ‘totally controlled’ and 6 = ‘severely uncontrolled.’ Study staff scored question 7 based on % predicted FEV1 (ideally pre-bronchodilator). The total score=average of first 6 questions. Baseline=the ACQ-6 measurement taken prior to first dose of randomized study drug. The single missing score was interpolated by utilizing prior or subsequent completions of the questionnaire. Estimates were from a mixed effects model with treatment, subject population (non-atopic vs. atopic), treatment by subject population interaction, baseline ACQ-6 and region as fixed effects and center nested within region as random effects.|baseline,12 weeks|||score||Standard Error|Least Squares Mean
661636|NCT01836471|Secondary|Change From Baseline in Trough FEV1 (L) in Non-atopic Compared to Atopic Patients at Week 12 - Full Analysis Set|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Baseline is defined as the FEV1 measurement taken prior to the first dose of randomized study drug.
Data within 6 hr of rescue medication use is excluded from this analysis. For subjects with missing trough FEV1 (L) at Week 12, the last post baseline observation were used (LOCF).
Estimates are from a mixed effects model with treatment, subject population, treatment by subject population interaction, baseline trough FEV1 and region as fixed effects and center nested within region as random effects. Full analysis set included all randomized subjects who received at least one dose of study drug."|baseline,12 weeks|||liter||Standard Error|Least Squares Mean
661637|NCT01836471|Secondary|Change From Baseline in Trough FEV1 (L) in Atopic Patients at Week 12 - Full Analysis Set|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Baseline is defined as the FEV1 measurement taken prior to the first dose of randomized study drug.
Data within 6 hr of rescue medication use is excluded from this analysis. For subjects with missing trough FEV1 (L) at Week 12, the last post baseline observation were used (LOCF).
Estimates are from a mixed effects model with treatment, subject population (non-atopic vs. atopic), treatment by subject population interaction, baseline trough FEV1 and region as fixed effects and center nested within region as random effects. Full analysis set included all randomized subjects who received at least one dose of study drug."|baseline,12 weeks|||liter||Standard Error|Least Squares Mean
661638|NCT01836471|Primary|Change From Baseline in Trough FEV1 (L) in Non-atopic Patients at Week 12 - Full Analysis Set|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Baseline is defined as the last available FEV1 measurement taken prior to the first dose of randomized study drug.
Data within 6 hr of rescue medication use is excluded from this analysis. For subjects with missing trough FEV1 (L) at Week 12, the last post baseline observation were used (LOCF).
Estimates are from a mixed effects model with treatment, subject population (non-atopic vs. atopic), treatment by subject population interaction, baseline trough FEV1 and region as fixed effects and center nested within region as random effects. Full analysis set included all randomized subjects who received at least one dose of study drug."|baseline,12 weeks|||liter||Standard Error|Least Squares Mean
661640|NCT01836458|Secondary|Median Time to Fever Clearance|Fever is monitored on participants every 4 hours for the first 24 hours, then every 6 hours until negative reading obtained.|Day 1 to Day 5|Pharmacodynamic Analysis Set includes all enrolled patients||hours||90% Confidence Interval|Median
661641|NCT01836458|Secondary|Median Time to Parasite Clearance|Parasite clearance time will be estimated using thick/thin blood films.|pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, 48, 54, 60, 66, 72 hours post dose of KAE609|Pharmacodynamic Analysis Set includes all enrolled patients||hours||95% Confidence Interval|Median
661642|NCT01836458|Primary|Minimum Inhibitory Concentration (MIC) of KAE609|To observe the exposure-response (PK/PD) relationship for a single dose of KAE609. The key parameter is MIC, defined as the concentration at which the relative rate of change in parasitemia is equal to zero. Approximation of MIC will assist in identifying the optimal dose of KAE609, which will be one component of a future combination antimalarial. MIC could not be determined due to small sample size no data was collected from any participants.|Up to Day 8 after a single dose of KAE609|The primary Outcome Measure (OM) could not be determined due to small sample size no data was collected from any participants.|||||
661643|NCT01836133|Secondary|Proportions of Participants With Adverse Events (AEs), Serious AEs, and AEs of Special Interest (AESIs)|An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events. A SAE was any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant, according to national cancer institute (NCI) common terminology criteria for adverse events (CTCAE) criteria version 4.0. An AESI was defined as interstitial pulmonary disease.|Baseline up to 3 years|The safety analysis population included all enrolled participants who received a single dose of erlotinib.||Proportion of participants||95% Confidence Interval|Number
661644|NCT01836133|Secondary|Percentage of Participants With Overall Response|Overall response was defined, based on response evaluation criteria in solid tumours (RECIST) v 1.1, as complete response (CR) plus partial response (PR). CR: complete disappearance of all target lesions; PR: at least 30% decrease in the sum of the longest diameter of all target lesions taking as reference the baseline sum of all target lesions.|Approximately 3 years|The effectiveness analysis population included all enrolled participants in the study.||Percentage of participants||95% Confidence Interval|Number
661645|NCT01836133|Primary|Progression-Free Survival (PFS)|PFS was defined as the time from initial dose of erlotinib to progression or death from any cause.|Approximately 3 years|The effectiveness analysis population included all enrolled participants in the study.||months||95% Confidence Interval|Median
661646|NCT01836042|Primary|Rate of Sight-threatening Adverse Events|The primary endpoint is the occurrence of sight-threatening adverse events. The rate of sight-threatening adverse events at each visit will be calculated for the three treatment groups (randomized control group, randomized iStent group, and non-randomized iStent group) separately. The summary will also be performed for pooling the randomized iStent and non-randomized iStent group.|80 Month average|||percentage of subjects|||Number
661647|NCT01835912|Other Pre-specified|Rate of Perceived Exertion|"Rate of perceived exertion (RPE) was recorded after each 200 metre swimming performance
RPE scale is from 6-20. Minimum = 6 (level of exertion equal to lying down) and Maximum = 20 (maximal perceived exertion)
Numbers reported are the average of the RPE recorded for all 10 participants."|Rate of Perceived Exertion after each 200m swimming performance|||units on a scale (6-20)||Standard Error|Mean
661648|NCT01835912|Secondary|Lactate|lactate measured at 3min post trial|3 min post performance|||mmol/L||Standard Error|Mean
661649|NCT01835912|Primary|Time|"time to complete 200 metre swimming performances in seconds
Participants chose type of swim stroke to swim a maximal effort 200 metre performance"|once each 200m performance|||seconds||Standard Error|Mean
661650|NCT01835899|Secondary|AUCt,ss|Area under the concentration-time curve of BI 1015550 in plasma at steady state over a uniform dosing interval t.|311:55h; 312:15h; 312:30h; 312:45; 313h; 313:15h; 313:30h; 314h; 315h; 316h; 318h; 320h; 322h and 324h after first drug administration; last drug administration was at 312 h.|PK set||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
661651|NCT01835899|Secondary|Cmax,ss|Maximum measured concentration of BI 1015550 in plasma at steady state over a uniform dosing interval t.|311:55h (hours); 312:15h; 312:30h; 312:45; 313h; 313:15h; 313:30h; 314h; 315h; 316h; 318h; 320h; 322h; 324h; 336h; 346h; 360h; 384h & 408h after first drug administration; last drug administration was at 312 h.|PK set||nmol/L||Geometric Coefficient of Variation|Geometric Mean
661652|NCT01835899|Secondary|AUC0-infinity|Area under the concentration-time curve of BI 1015550 in plasma over the time interval from 0 extrapolated to infinity.|0:15h(hours); 0:30h; 0:45h; 1h;1:15h;1:30h; 2h;3h; 4h; 6h; 8h;10h; 12h; 24h; 34h and 47:55h after first drug administration.|PK set||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
661653|NCT01835899|Secondary|AUCt,1|Area under the concentration-time curve of BI 1015550 in plasma over a uniform dosing interval t after administration of the first dose|0:15h(hours); 0:30h; 0:45h; 1h;1:15h;1:30h; 2h;3h; 4h; 6h; 8h;10h and 12h after first drug administration|PK set||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
661654|NCT01835899|Secondary|Cmax|Maximum measured concentration of BI 1015550 in plasma.|0:15h(hours); 0:30h; 0:45h; 1h;1:15h;1:30h; 2h;3h; 4h; 6h; 8h;10h; 12h; 24h; 34h and 47:55h after first drug administration.|The PK analysis set (PKS) included all subjects of the TS who provided at least 1 observation for at least 1 secondary PK endpoint and who did not have a protocol violation relevant to the evaluation of PK.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
661655|NCT01835899|Primary|Percentage of Subjects With Drug-related Adverse Events|Percentage of subjects with drug related Adverse events, as assessed by the investigator.|From first drug administration until last drug administration, upto 18 days.|The treated set (TS) included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.||Percentage of participants|||Number
661656|NCT01835756|Secondary|Satisfaction With Study Outcome|"At study endpoint, the subject was asked to rate how satisfied he or she was with any overall change in low back pain attained following the procedure administration phase with the Erchonia MLS Laser, using the following five-point scale:
Very Satisfied Somewhat Satisfied Neither Satisfied nor Dissatisfied Not Very Satisfied Not at All Satisfied
Results are reported as the number of subjects who reported being 'Very Satisfied' or 'Somewhat Satisfied' with the study outcome."|4 Months|||participants|||Number
661657|NCT01835756|Secondary|Change in Low Back Pain Visual Analog Scale (VAS) Score|The VAS is a straight line scale that is marked on one end with a '0' for 'no pain' and at the other end with '100' for 'worse pain imaginable.' A higher score on the VAS indicates a greater level of pain, and a lower score indicates a lower level of pain.A decrease in the VAS pain rating indicates a reduction in low back pain and is positive for study success. An increase in the VAS pain rating indicates a worsening of low back pain and is negative for study success. The mean change in low back pain score recorded on the Visual Analog Scale (VAS) from baseline to 4 months post-procedure was calculated for each treatment group.|Baseline and 4 Months|||units on a scale||Standard Deviation|Mean
661658|NCT01835756|Primary|Difference in the Proportion of Primary Outcome Successes Between Treatment Groups|Primary outcome success for an individual subject was defined as a 30% or greater change (decrease) in VAS pain score at 4 months post-procedure relative to baseline. The VAS is a straight line scale that is marked on one end with a '0' for 'no pain' and at the other end with '100' for 'worse pain imaginable.' A higher score indicates a greater level of pain, and a lower score indicates a lower level of pain. A negative (-) percent change in VAS rating indicates a decrease in pain level and is positive for individual subject success. A positive (+) percent change indicates an increase in pain level and is negative for individual subject success. Overall study success was defined as a 35% or greater difference in the proportion of individual primary outcome successes in each treatment group, in favor of the active treatment group.|4 Months|||participants|||Number
661659|NCT01835743|Secondary|Change in Heel Pain Score on the Visual Analog Scale (VAS)|Each subject rated heel pain upon taking the first few steps of the day on the 0-100 mm (0 -10 cm) Visual Analog Pain Scale (VAS) from '0: no pain at all' to '100: worst pain imaginable'. The higher the VAS score, the greater the heel pain experienced. Change in heel pain score on the VAS was calculated as the heel pain VAS score at week 5 (2 weeks after procedure administration end) minus the heel pain VAS score at baseline evaluation. A negative (-) change in heel pain VAS score across the evaluation period indicated a decrease (improvement) in heel pain and was positive for study success. A positive (+) change in heel pain VAS score indicated an increase (worsening) in heel pain and was negative for study success.|baseline and 5 weeks|||scores on a 0-100 VAS scale||Standard Deviation|Mean
661660|NCT01835743|Primary|Number of Participants Who Attained a Change of -30% or Greater in the VAS Score|Each subject rated heel pain upon taking the first few steps of the day on the 0-100 mm (0 -10 cm) Visual Analog Pain Scale (VAS) from '0: no pain at all' to '100: worst pain imaginable'. The higher the VAS score, the greater the heel pain experienced. Percent (%) change in VAS score was calculated as the % difference in VAS score at week 5 (2 weeks after procedure administration end) relative to baseline evaluation. A negative (-) % difference in VAS score across the evaluation period indicated a decrease (improvement) in heel pain, and a positive (+) % difference in VAS score indicated an increase (worsening) in heel pain. A change of -30% or greater in the VAS score was considered positive for study success. The number of participants who attained a change of -30% of greater in VAS score across the evaluation period was calculated for both subjects in the test group and in th placebo group as a proportion of the total number of subjects in each procedure group.|baseline and 5 weeks|||participants|||Number
661661|NCT01835496|Primary|T1/2 for Serum Deferiprone and Deferiprone 3-O-glucuronide|T1/2 (apparent terminal elimination half-life) was assessed over a 10-hour interval for deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained pre-dose and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 8, and 10 hours post-dose.|10-hour interval|||hr||Standard Deviation|Mean
661662|NCT01835496|Primary|AUC0-∞ for Serum Deferiprone and Deferiprone 3-O-glucuronide|AUC0-∞ (area under the curve, zero to infinity) was assessed over a 10-hour interval for deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained pre-dose and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 8, and 10 hours post-dose.|10-hour interval|||µg*hr/mL||Standard Deviation|Mean
661663|NCT01835496|Primary|Tmax for Deferiprone and Deferiprone 3-O-glucuronide|"Tmax (time to the maximum measured serum concentration) was assessed over a 10-hour interval for deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained pre-dose and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 8, and 10 hours post-dose.
The results of the Tmax parameter are reported as the median and range (other parameters are reported as mean and standard deviation)."|10-hour interval|||hr||Full Range|Median
661664|NCT01835496|Secondary|Frequency of Serious Adverse Events||From Day 1 (Dosing) to Day 30 post-dose|||participants|||Number
661665|NCT01835496|Secondary|Frequency of Adverse Events||From Day 1 (Dosing) to Day 7 plus/minus 3 days (Follow-up)|||participants|||Number
661666|NCT01835496|Primary|Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide|Cmax (maximum measured serum concentration) was assessed over a 10-hour interval for deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained pre-dose and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 8, and 10 hours post-dose.|10-hour interval|||μg/mL||Standard Deviation|Mean
661667|NCT01835470|Secondary|Number of Participants With Positive Immunogenicity During the Short Term Period|A positive immunogenicity response for 'Cytotoxic T-lymphocyte antigen (CTLA4), Immunoglobulin (Ig)', 'Ig and/or Junction Region', respectively = (1) missing baseline immunogenicity measurement and positive analytical laboratory reported immunogenicity response post-baseline (2) negative baseline immunogenicity response and positive analytical laboratory reported immunogenicity response post-baseline (3) positive baseline immunogenicity response and positive analytical laboratory reported immunogenicity response post-baseline with titer value strictly greater than the baseline titer value. Assessment based on assay cutpoint value. Serum samples were collected prior to study medication at Week 0 (Day 1), Week 8 (Day 57), and Week 16 (Day 113) in the short term period. Participants who early discontinued from the study or complete and did not switch to commercial abatacept had a serum sample collected on final visit or early termination visit, 28, 84 and 168 days after the last dose.|Day 1 up to Week 16 (Day 113)|Immunogenicity analysis population: All participants who received at least one dose of study medication and who had at least one immunogenicity result reported after start of study medication||participants|||Number
661702|NCT01835132|Secondary|Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 2 Compared to Baseline|Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).|Baseline and Week 2|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.||mmHg|eyes|Standard Deviation|Mean
661668|NCT01835470|Secondary|Trough Observed Concentration (Ctrough) of Abatacept During the Short Term Period|Blood samples were collected at 0 hour (pre-dose) on Days 15 and 29 and at 0 hour (pre-dose) and 0.5 hours (post dose) on Days 57, 85, and 113. A blood sample was also collected on an interim visit that occurred on any day between Day 92 and Day 110. ug/mL=micrograms/milliliter|9 time points up to Week 16 (Day 113)|Pharmacokinetic (PK) Analysis Population: All participants who received at least one dose of study medication and who had at least one adequate PK result reported after start of study medication. The 'n' signifies those participants who received study drug and were evaluated for this measure (each group respectively).||ug/mL||Geometric Coefficient of Variation|Geometric Mean
661669|NCT01835470|Secondary|Maximum Observed Concentration (Cmax) of Abatacept During the Short Term Period|Cmax was obtained from the serum concentration versus time data after intravenous administration of abatacept. Blood samples were collected at 0 hour (pre-dose) on Days 15 and 29 and at 0 hour (pre-dose) and 0.5 hours (post dose) on Days 57, 85, and 113. A blood sample was also collected on an interim visit that occurred on any day between Day 92 and Day 110. ug/mL=micrograms/milliliter|9 time points up to Week 16 (Day 113)|Pharmacokinetic (PK) Analysis Population: All participants who received at least one dose of study medication and who had at least one adequate PK result reported after start of study medication. The 'n' signifies those participants who received study drug and were evaluated for this measure (each group respectively).||ug/mL||Geometric Coefficient of Variation|Geometric Mean
661670|NCT01835470|Secondary|Number of Participants With Death, Serious Adverse Events (SAEs), Drug-Related SAEs, Discontinuation Due to Drug-Related SAEs, Drug-Related Adverse Events (AEs), and Discontinuation Due to Drug-Related AEs During the Short Term Period|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. SAEs also include hospitalizations for elective surgical procedures. Drug-related=related or missing relationship to study drug. Data includes all events from the date of the first dose of the study drug up to 56 days post the last dose of the study drug in the short-term period or start of the long-term period, whichever occurred first.|Day 1 up to 56 days post Week 16 (Day 113); approximately 6 months|All Treated Participants: All participants who received at least one dose of study medication||participants|||Number
661671|NCT01835470|Secondary|Median Percentage of Improvement From Baseline in Physical Function as Assessed by the Childhood Health Assessment Questionnaire (CHAQ) Disability Index at Week 16|Physical function was evaluated using the disability section of the Childhood Health Assessment Questionnaire (CHAQ). The questionnaire was derived from the adult HAQ. The disability section assessed physical functions in 8 domains: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities. The questions were evaluated on a 4-point scale: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty and 3 =unable to do. Higher scores indicate greater dysfunction. A disability index was calculated as the mean of the 8 functional scales. The percentage of Improvement from baseline was calculated using the following equation: (Baseline value - Post-baseline value) / Baseline value x 100.|Week 16 (Day 113)|All Treated Participants: All participants who received at least one dose of study medication||percentage of improvement from baseline||Inter-Quartile Range|Median
661672|NCT01835470|Secondary|Percentage of Participants Experiencing a American College of Rheumatology Pediatric 50, 70, 90 Response or Inactive Disease at Week 16|ACR PED 50 response is defined as '≥50% improvement' and '≥3 of the 6 Juvenile Idiopathic Arthritis (JIA) core set' and ≥30% worsening in not more than 1 of the 6 JIA core set variables. ACR PED 70 response is defined as '≥70% improvement' and '≥3 of the 6 JIA core set' and ≥30% worsening in not more than 1 of the 6 JIA core set variables. ACR PED 90 response is defined as '≥90% improvement' and '≥3 of the 6 JIA core set' and ≥30% worsening in not more than 1 of the 6 JIA core set variables. Inactive disease status is defined as no active joints, physician’s global assessment of disease severity equal or less than 10mm and C-reactive protein (CRP) within normal limits (0.3 mg/dL). A non-responder imputation is applied. mm=millimeter; mg/dL=milligrams/deciliter|Week 16 (Day 113)|All Treated Participants: All participants who received at least one dose of study medication||percentage of participants||95% Confidence Interval|Number
661673|NCT01835470|Primary|Percentage of Participants Experiencing a American College of Rheumatology (ACR) Pediatric 30 Response at Week 16|American College of Rheumatology (ACR) pediatric (PED) 30 response was defined as '≥30% improvement' and '≥3 of the 6 Juvenile Idiopathic Arthritis (JIA) core set' and ≥30% worsening in not more than 1 of the 6 JIA core set variables. JIA core set variables defined as the number of active joints, number of joints with Limit of Motion (LOM), physician's global assessment of disease severity, patient global assessment of overall well being, parent assessment of physical function, and acute phase reactant value. A non-responder imputation was applied.|Week 16 (Day 113)|All Treated Participants: All participants who received at least one dose of study medication||percentage of participants||95% Confidence Interval|Number
661674|NCT01835431|Secondary|Number of Hyperglycaemic Episodes (PG Above 14.0 mmol/L (250 mg/dL) Where Subject Looks/Feels Ill With Ketosis (Blood Ketones Above 1.5 mmol/L)|The episode of hyperglycaemia was noted when the glucose measurement was 14.0mmol/L or above and the subject looked /felt ill. The ketone meaurement involved an additional finger prick and ketosis was considered present if blood ketones were higher than 1.5mmol/L|After 16 weeks of treatment|The SAS included all subjects receiving at least one dose of the trial product or its comparator||episodes|||Number
661675|NCT01835431|Secondary|Number of Hyperglycaemic Episodes (PG Above 14.0 mmol/L (250 mg/dL) Where Subject Looks/Feels Ill|The episode of hyperglycaemia was noted when the glucose measurement was 14.0mmol/L or above and the subject looked /felt ill.|After 16 weeks of treatment|The SAS included all subjects receiving at least one dose of the trial product or its comparator||episodes|||Number
661676|NCT01835431|Secondary|Number of Treatment Emergent Nocturnal Confirmed Hypoglycaemic Episodes|The confirmed hypoglycaemic episodes occurring between 23:00 and 07:00 were considered for this endpoint|After 16 weeks of treatment|The SAS included all subjects receiving at least one dose of the trial product or its comparator||episodes|||Number
661778|NCT01833988|Secondary|Difference Between Closed-loop and Open-loop in Average BG as Determined From All HemoCue Measurements Taken During the Nighttime Including All Extra Measurements Taken for Hypoglycemia Monitoring.||1 week|||mg/dl||Standard Deviation|Mean
661677|NCT01835431|Secondary|Number of Treatment Emergent Confirmed Hypoglycaemic Episodes (Plasma Glucose (PG) Below 3.1mmol/L (56mg/dL) or Severe Hypoglycaemia)|"Treatment emergent hypoglycaemic episodes (PG < 3.1 mmol/L (56 mg/dL) or severe hypoglycaemia).
Confirmed hypoglycaemic episodes were defined as episodes that were either:
Severe (i.e. the child is having altered mental status and cannot assist in their care, is semiconscious or unconscious or in coma with or without convulsions and may require parenteral therapy (glucagon or i.v. glucose), or
An episode biochemically confirmed by PG value of <3.1 mmol/L (56 mg/dL), with or without symptoms consistent with hypoglycaemia."|After 16 weeks of treatment|The SAS included all subjects receiving at least one dose of the trial product or its comparator||episodes|||Number
661678|NCT01835431|Secondary|Incidence of Treatment Emergent Adverse Events (TEAEs)|A Treatment Emergent Adverse Event (TEAE) was defined as an event with onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day on randomised treatment.|After 16 weeks of treatment|The Safety analysis set (SAS) included all subjects receiving at least one dose of the trial product or its comparator||number of events|||Number
661679|NCT01835431|Secondary|Change From Baseline in Fasting Plasma Glucose|Change from baseline in FPG after 16 weeks of treatment. Change from baseline summary statistics at week 16 contains only those who had both baseline and week 16 assesment.|week 0, week 16|The FAS included all randomised subjects. 338 subjects had assessment at baseline, 326 had assessment at week 16, 2 subjects were withdrawn before exposure and 22 subjects week 16 assessment was not done.||mmol/L||Standard Deviation|Mean
661680|NCT01835431|Primary|Change From Baseline in HbA1c (Glycosylated Haemoglobin) (%)|Percentage point change in glycosylated haemoglobin A1c (HbA1c) from baseline (week 0) to 16 Weeks. Change from baseline summary statistics at week 16 contains only those who had both baseline and week 16 assesment.|Week 0 to week 16|The FAS included all randomised subjects. 20 subjects were withdrawn and only 4 subjects though completed the study did not have assesments.||percentage (%)||Standard Deviation|Mean
661681|NCT01835379|Secondary|Time to Wound Closure|Kaplan-Meier (K-M) analysis was employed to estimate the median time in weeks to complete ulcer closure.|During the 12 Week treatment period|||weeks||95% Confidence Interval|Median
661682|NCT01835379|Primary|Percentage of Wounds Closed||At the end of 12 Weeks|||percentage of wounds closed|||Number
661683|NCT01835262|Primary|Numeric Rating Scale of Pain|"We will compare efficacy as a difference between 2 groups in pain score at 30 minutes post-analgesic administration. The primary outcome is the difference between 2 groups in pain score at 30 minutes.
Pain will be measured via Numeric rating scale from 0 to 10 with 0 being no pain, 5 being moderate pain, and 10 being severe pain"|30 minutes|||Units on a scale||Standard Deviation|Mean
661684|NCT01835132|Secondary|Changes in Scleral Grading From Baseline to Week 52|Scleral inflammation was summarized on an ordinal scale as either none, minimal/trace, mild, moderate, severe or necrotizing inflammation in the four quadrants of the study eye (superonasal [SN], superotemporal [ST], inferotemporal [IT], and inferonasal [IN]) for each participant at each visit. The exact change from Baseline to Week 52 for each participant (such as from mild to severe) cannot be quantified; therefore, we chose not to report due to the difficulty of reporting a quantitative change in each quadrant for each participant within the limited parameters allowed by PRS.|Baseline and Week 52||||||
661685|NCT01835132|Secondary|Number of Participants With Loss of ≥ 15 Early Treatment Diabetic Retinopathy Study (ETDRS) Letters|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Post-injection through study completion, up to 78 weeks per participant|Eight participants were active from Baseline to Week 28. Of the 8 active participants, one participant had two study eyes and was active to Week 28. Two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52. Three participants were active from Week 52 to study end.||participants|eyes||Number
661686|NCT01835132|Secondary|Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Final Safety Visit Compared to Baseline|Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).|Baseline and Final Visit|Eight participants were active from Baseline to Week 28. Of the 8 active participants, one participant had two study eyes and was active to Week 28. Two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52. Three participants were active from Week 52 to study end.||mmHg|eyes|Standard Deviation|Mean
661687|NCT01835132|Secondary|Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 62 Compared to Baseline|Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).|Baseline and Week 62|Eight participants were active from Baseline to Week 28. Of the 8 active participants, one participant had two study eyes and was active to Week 28. Two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52. Three participants were active from Week 52 to study end.||mmHg|eyes|Standard Deviation|Mean
661688|NCT01835132|Secondary|Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 58 Compared to Baseline|Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).|Baseline and Week 58|Eight participants were active from Baseline to Week 28. Of the 8 active participants, one participant had two study eyes and was active to Week 28. Two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52. Three participants were active from Week 52 to study end.||mmHg|eyes|Standard Deviation|Mean
661689|NCT01835132|Secondary|Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 54 Compared to Baseline|Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).|Baseline and Week 54|Eight participants were active from Baseline to Week 28. Of the 8 active participants, one participant had two study eyes and was active to Week 28. Two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52. Three participants were active from Week 52 to study end.||mmHg|eyes|Standard Deviation|Mean
661721|NCT01835015|Secondary|Apparent Systemic (or Total Body) Clearance From Serum Following Extravascular Administration (CL/F)|Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method.|Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85|This parameter was not calculated as AUClast and AUCall were considered sufficient to characterize the systemic exposure to CLG561.|||||
661690|NCT01835132|Secondary|Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 52A Compared to Baseline|"This visit represents the beginning of the as-needed 2nd Extension Phase at Week 52. If eligible, participants continued with injections at Wks 52, 54, 58 and 62.
Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg)."|Baseline and Week 52A|Eight participants were active from Baseline to Week 28. Of the 8 active participants, one participant had two study eyes and was active to Week 28. Two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52. Three participants were active from Week 52 to study end.||mmHg|eyes|Standard Deviation|Mean
661691|NCT01835132|Secondary|Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 52 Compared to Baseline|Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).|Baseline and Week 52|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.||mmHg|eyes|Standard Deviation|Mean
661692|NCT01835132|Secondary|Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 40 Compared to Baseline|Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).|Baseline and Week 40|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.||mmHg|eyes|Standard Deviation|Mean
661693|NCT01835132|Secondary|Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 36 Compared to Baseline|Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).|Baseline and Week 36|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.||mmHg|eyes|Standard Deviation|Mean
661694|NCT01835132|Secondary|Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 32 Compared to Baseline|Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).|Baseline and Week 32|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.||mmHg|eyes|Standard Deviation|Mean
661695|NCT01835132|Secondary|Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 28 Compared to Baseline|Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).|Baseline and Week 28|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.||mmHg|eyes|Standard Deviation|Mean
661696|NCT01835132|Secondary|Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 24 Compared to Baseline|Mean Change in Intraocular pressure (IOP) is measured and reported as change in IOP between baseline and 24 weeks in millimeters of mercury (mmHg).|Baseline and Week 24|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.||mmHg|eyes|Standard Deviation|Mean
661697|NCT01835132|Secondary|Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 20 Compared to Baseline|Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).|Baseline and Week 20|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.||mmHg|eyes|Standard Deviation|Mean
661698|NCT01835132|Secondary|Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 16 Compared to Baseline|Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).|Baseline and Week 16|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.||mmHg|eyes|Standard Deviation|Mean
661699|NCT01835132|Secondary|Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 12 Compared to Baseline|Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).|Baseline and Week 12|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.||mmHg|eyes|Standard Deviation|Mean
661700|NCT01835132|Secondary|Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 8 Compared to Baseline|Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).|Baseline and Week 8|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.||mmHg|eyes|Standard Deviation|Mean
661701|NCT01835132|Secondary|Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 4 Compared to Baseline|Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).|Baseline and Week 4|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.||mmHg|eyes|Standard Deviation|Mean
661779|NCT01833988|Secondary|Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Standard Deviation of CGMG Values at Night (11:00 PM to 7:00 AM)||1 week|||Standard deviation of mean values|||Number
661703|NCT01835132|Secondary|Mean Change in Visual Acuity in the Study Eye (or Eyes) at Final Safety Visit Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Final Visit|Eight participants were active from Baseline to Week 28. Of the 8 active participants, one participant had two study eyes and was active to Week 28. Two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52. Three participants were active from Week 52 to study end.||ETDRS letters|eyes|Standard Deviation|Mean
661704|NCT01835132|Secondary|Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 62 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 62|Eight participants were active from Baseline to Week 28. Of the 8 active participants, one participant had two study eyes and was active to Week 28. Two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52. Three participants were active from Week 52 to study end.||ETDRS letters|eyes|Standard Deviation|Mean
661705|NCT01835132|Secondary|Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 58 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 58|Eight participants were active from Baseline to Week 28. Of the 8 active participants, one participant had two study eyes and was active to Week 28. Two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52. Three participants were active from Week 52 to study end.||ETDRS letters|eyes|Standard Deviation|Mean
661706|NCT01835132|Secondary|Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 54 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 54|Eight participants were active from Baseline to Week 28. Of the 8 active participants, one participant had two study eyes and was active to Week 28. Two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52. Three participants were active from Week 52 to study end.||ETDRS letters|eyes|Standard Deviation|Mean
661707|NCT01835132|Secondary|Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 52A Compared to Baseline|"This visit represents the beginning of the as-needed 2nd Extension Phase at Week 52. If eligible, participants continued with injections at Wks 52, 54, 58 and 62.
Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20."|Baseline and Week 52A|Eight participants were active from Baseline to Week 28. Of the 8 active participants, one participant had two study eyes and was active to Week 28. Two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52. Three participants were active from Week 52 to study end.||ETDRS letters|eyes|Standard Deviation|Mean
661708|NCT01835132|Secondary|Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 52 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 52|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.||ETDRS letters|eyes|Standard Deviation|Mean
661709|NCT01835132|Secondary|Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 40 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 40|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.||ETDRS letters|eyes|Standard Deviation|Mean
661710|NCT01835132|Secondary|Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 36 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 36|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.||ETDRS letters|eyes|Standard Deviation|Mean
661711|NCT01835132|Secondary|Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 32 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 32|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.||ETDRS letters|eyes|Standard Deviation|Mean
661712|NCT01835132|Secondary|Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 28 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 28|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.||ETDRS letters|eyes|Standard Deviation|Mean
661713|NCT01835132|Secondary|Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 24 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 24|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.||ETDRS letters|eyes|Standard Deviation|Mean
661714|NCT01835132|Secondary|Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 20 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 20|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.||ETDRS letters|eyes|Standard Deviation|Mean
661715|NCT01835132|Secondary|Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 16 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 16|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.||ETDRS letters|eyes|Standard Deviation|Mean
661716|NCT01835132|Secondary|Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 12 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 12|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.||ETDRS letters|eyes|Standard Deviation|Mean
661717|NCT01835132|Secondary|Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 8 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 8|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.||ETDRS letters|eyes|Standard Deviation|Mean
661718|NCT01835132|Secondary|Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 4 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 4|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.||ETDRS letters|eyes|Standard Deviation|Mean
661719|NCT01835132|Secondary|Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 2 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 2|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.||ETDRS letters|eyes|Standard Deviation|Mean
661720|NCT01835132|Primary|Number of Participants With at Least a 2-step Reduction or Reduction to Grade 0 in Scleral Inflammation in the Study Eye (or Eyes), According to the National Eye Institute (NEI) Photographic Scleritis Grading System, on or Before the Week 16 Visit.|Scleral inflammation was graded following 10% Phenylephrine application with an ordinal scale of 0 (no scleral inflammation with complete blanching of vessels), 0.5+ (minimal/trace inflammation with localized pink appearance of the sclera around minimally dilated deep episcleral vessels), 1+ (mild inflammation with diffuse pink appearance of the sclera around mildly dilated deep episcleral vessels), 2+ (moderate inflammation with purplish pink appearance of the sclera with tortuous and engorged deep episcleral vessels), 3+ (severe inflammation with diffuse significant redness of sclera, the details of superficial and deep episcleral vessels can’t be observed), and 4+ (necrotizing inflammation with diffuse redness of the sclera with scleral thinning and uveal show).|Baseline and Week 16|||participants|||Number
661722|NCT01835015|Secondary|The Apparent Volume of Distribution During the Terminal Elimination Phase Following Extravascular Administration (Vz/F)|Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method.|Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85|This parameter was not calculated as AUClast and AUCall were considered sufficient to characterize the systemic exposure to CLG561.|||||
661723|NCT01835015|Secondary|Terminal Elimination Half-life (T½)|Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method.|Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85|This parameter was not calculated as AUClast and AUCall were considered sufficient to characterize the systemic exposure to CLG561.|||||
661724|NCT01835015|Secondary|"Area Under the Serum Concentration-time Curve From Time Zero to Time t Where t is a Defined Time Point After Administration [AUC(0-t)]"|Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method.|Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85|This parameter was not calculated as AUClast and AUCall were considered sufficient to characterize the systemic exposure to CLG561.|||||
661725|NCT01835015|Secondary|Dose-normalized Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-last)/D]|Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental PK method.|Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85|This analysis population includes all subjects who received investigational product, completed at least 1 post-injection study visit and for whom serum concentration-time data is available, provided no collection or analytical deviations which would affect the integrity of the data occurred.||hr*ng/mL/mg||Standard Deviation|Mean
661726|NCT01835015|Secondary|Dose Normalized Observed Maximum Serum Concentration Following Drug Administration (Cmax/D)|Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental PK method.|Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85|This analysis population includes all subjects who received investigational product, completed at least 1 post-injection study visit and for whom serum concentration-time data is available, provided no collection or analytical deviations which would affect the integrity of the data occurred.||ng/mL/mg||Standard Deviation|Mean
661727|NCT01835015|Secondary|Time to Reach the Maximum Serum Concentration After Drug Administration (Tmax)|Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental PK method.|Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85|This analysis population includes all subjects who received investigational product, completed at least 1 post-injection study visit and for whom serum concentration-time data is available, provided no collection or analytical deviations which would affect the integrity of the data occurred.||hours||Standard Deviation|Mean
661728|NCT01835015|Secondary|Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-last)]|Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental PK method.|Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85|This analysis population includes all subjects who received investigational product, completed at least 1 post-injection study visit and for whom serum concentration-time data is available, provided no collection or analytical deviations which would affect the integrity of the data occurred.||hr*ng/mL||Standard Deviation|Mean
661729|NCT01835015|Secondary|Area Under the Serum Concentration-time Curve (AUC) From Time Zero to All [AUC(0-all)]|Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental pharmacokinetic (PK) method.|Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85|This analysis population includes all subjects who received investigational product, completed at least 1 post-injection study visit and for whom serum concentration-time data is available, provided no collection or analytical deviations which would affect the integrity of the data occurred.||hr*ng/mL||Standard Deviation|Mean
661730|NCT01835015|Primary|Number of Subjects With a Change From Normal to Abnormal in Ocular Signs at Any Post-Therapy Visit as Compared to Baseline Assessment|A slit-lamp biomicroscopy examination was performed to evaluate the anterior segment of the eye. Subjects having a normal baseline evaluation were examined at subsequent visits, and any change from normal to abnormal was recorded. Criteria for reclassifying from normal to abnormal were left to the opinion of the investigators. One eye (study eye) contributed to the analysis. None of the abnormalities were deemed related to the study medication.|Baseline, Day 2, Day 4, Day 8, Day 15, Day 29, Day 57, Day 85|This analysis population includes all enrolled subjects who received investigational product.||participants|||Number
661731|NCT01835015|Primary|Number of Subjects With Change From Normal to Abnormal in Fundus Examination at Any Post-Therapy Visit as Compared to Baseline Assessment|A dilated fundus examination was performed to evaluate the health of the retina, macula, choroid, and optic nerve. Subjects having a normal baseline evaluation were examined at subsequent visits, and any change from normal to abnormal was recorded. Criteria for reclassifying from normal to abnormal were left to the opinion of the investigators. One eye (study eye) contributed to the analysis. None of the abnormalities were deemed related to the study medication.|Baseline, Day 2, Day 4, Day 8, Day 15, Day 29, Day 57, Day 85|This analysis population includes all enrolled subjects who received investigational product.||participants|||Number
661732|NCT01835015|Primary|Mean Intra-Ocular Pressure (IOP) by Visit - Study Eye|IOP was measured by Goldmann applanation tonometry or tonopen, at the discretion of the Investigator, and reported in mmHg (millimeters of mercury). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye (study eye) contributed to the analysis.|Baseline, Day 1, Day 2, Day 4, Day 15, Day 29, Day 57, Day 85|"This analysis population includes all enrolled subjects who received investigational product. Here, n is the number of subjects with non-missing values at the specific time point for each arm group, respectively."||mmHg||Standard Deviation|Mean
661804|NCT01833845|Primary|Efficacy|To evaluate the effect of 16-week combination therapy with RBV plus HCQ following 8 weeks of monotherapy with RBV in HCV-infected patients.|24 weeks||||||
661733|NCT01835015|Primary|Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) by Visit - Study Eye|BCVA (with spectacles or other visual corrective devices) using Early Treatment Diabetic Retinopathy Study (ETDRS) testing was reported in letters read correctly. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.|Baseline, Day 2, Day 4, Day 15, Day 29, Day 57, Day 85|"This analysis population includes all enrolled subjects who received investigational product. Here, n is the number of subjects with non-missing values at the specific time point for each arm group, respectively."||letters||Standard Deviation|Mean
661734|NCT01834651|Secondary|Number of Patients With Evaluable Protein Content of Large Oncosomes From Baseline to First Documented Progression or Date of Death|This is a feasibility outcome to assess ability to measure protein content in large oncosomes in this population.|From baseline until the date of first documented progression or date of death from any cause, whichever comes first, assessed for an expected average of 28 weeks.|Only 12 samples were analyzed.||Participants|||Count of Participants
661735|NCT01834651|Secondary|Number of Participants With Grade 3/4 Adverse Events Related to Cabozantinib as Assessed Using CTCAE (v.4)|Each cycle is 28 days. Safety and tolerability was defined as related grade 3-4 AEs of doses of cabozantinib below 100 mg daily using common terminology criteria for adverse events (CTCAE)|Every 2 weeks for first 3 Cycles and every 4 weeks thereafter for an expected average of 28 weeks.|All patients||Participants|||Count of Participants
661736|NCT01834651|Secondary|Change in Levels of Serum Hepatocyte Growth Factor (HGF) and Vascular Endothelial Growth Factor (VEGF) Concentration|Mean change from baseline in levels of HGF and VEGF|12 weeks|HGF was evaluable in 16 patients who had viable research samples. VEGF was evaluable in 15 patients who had viable research samples.||pg/ml||Standard Deviation|Mean
661737|NCT01834651|Secondary|Number of Patients With NanoVelcro Appropriate for RNA in Circulating Tumor Cells|This is to provide a measure of feasibility using NanoVelcro to measure RNA in circulating tumor cells (CTC)|12 weeks|There were 16 patients evaluable for this outcome (1 patient did not have RECIST measurable disease)||Participants|||Count of Participants
661738|NCT01834651|Secondary|Change in Number of Circulating Tumor Cells (CTC) in Response to Cabozantinib|Change in number of CTC from baseline at 12 weeks|Baseline and 12 weeks|||CTCs/7.5 ml||Standard Deviation|Mean
661739|NCT01834651|Primary|Clinical Benefit Rate From Cabozantinib (XL184)|"Clinical benefit rate is defined as the combination of complete response, partial response, and stable disease as defined by modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by CT imaging and Prostate Cancer Working Group 2 (PCWG2) criteria.
Complete response (CR) defined as disappearance of all target lesions; Partial response (PR) >=30% decrease in som of diameters of target lesions (taking as reference the baseline), and stable disease, neither sufficient shrinkage to qualify for PR nor increase to qualify for progressive disease."|Baseline to 12 weeks after starting therapy|||Participants|||Count of Participants
661740|NCT01834404|Secondary|Peak Postprandial Level of Total Peptide Tyrosine-Tyrosine (PYY)|Plasma gastrointestinal hormone PYY was measured by radioimmunoassay.|Day 14, approximately 45 minutes after liquid meal|||pg/mL||Standard Error|Mean
661741|NCT01834404|Secondary|Peak Postprandial Level of Total Glucagon-Like Peptide-1 (GLP-1)|Plasma gastrointestinal hormone GLP-1 was measured by radioimmunoassay.|Day 14, approximately 45 minutes after liquid meal|||pg/mL||Standard Error|Mean
661742|NCT01834404|Secondary|Peak Postprandial Level of Cholecystokinin (CCK)|Plasma gastrointestinal hormone CCK was measured by radioimmunoassay based on an antibody with very low cross-reactivity to gastrin 17 and its sulfated counterpart, and to sensitivity to a concentration of 0.3 pmol/L.|Day 14, approximately 45 minutes after liquid meal|||pg/mL||Standard Error|Mean
661743|NCT01834404|Secondary|Fasting Ghrelin|Plasma gastrointestinal hormone total ghrelin was measured by radioimmunoassay.|Day 14, before liquid meal|||pg/mL||Standard Error|Mean
661744|NCT01834404|Secondary|Change in Postprandial Gastric Volume|Change between postprandial and fasting whole gastric volume by 99mTc-SPECT Imaging. A noninvasive SPECT method was used to measure gastric volume during fasting and 32 min after a liquid nutritional supplement meal. Subjects reported to the clinic after an overnight fast. 99mTC was given by an intravenous injection in the forearm. The first fasting scan was obtained, and the study medication was given s.c. After 10 min, a 2nd fasting post medication scan was obtained, and the meal consumed; then two serial postprandial scans were obtained. Each scan required 9-12 min. Tomographic images of the gastric wall were obtained throughout the long axis of the stomach using a dual-head gamma camera that rotates around the body. This allows assessment of the radiolabeled circumference of the gastric wall, rather than the intragastric content.|Day 13, approximately approximately 30 min after liquid meal|||mL||Standard Error|Least Squares Mean
661745|NCT01834404|Secondary|Solid Gastric Emptying: Proportion Remaining at 4 Hours|At visit 6 subjects took part in a gastric emptying by scintigraphy test. Subjects were given a scrambled egg breakfast with toast and a glass of milk. The eggs and milk contained a small amount of radioactive substance. At the completion of the meal, subjects stood in front of a special camera and pictures were taken at specific intervals. This outcome measure is the proportion of the radiolabeled meal remaining at 4 hours.|Day 15, approximately 4 hours after radiolabeled meal was ingested|||proportion of meal remaining||Standard Error|Least Squares Mean
661746|NCT01834404|Primary|Buffet Meal Intake|"At visit 4 subjects underwent imaging to measure the volume of their stomach, fasting and after ingesting a liquid nutrient drink. Four hours after the liquid meal, subjects were invited to eat, over a 30-minute period, a standard all you can eat meal vegetable lasagna, vanilla pudding, and skim milk. The total Kcal of the food consumed was analyzed by using validated software."|Day 13, approximately 4.5 hours after liquid meal|||Kcal||Standard Error|Mean
661747|NCT01834404|Primary|Maximum Tolerated Volume|At visit 5, subjects did a satiation/nutrient drink test. Participants recorded their sensations every 5 minutes using a numerical scale from 0-5, with level 0 being no symptoms, level 3 corresponding to fullness sensation after a typical meal, and level 5 corresponding to the maximal tolerated volume (maximum or unbearable fullness/satiation). This measure is the volume consumed when the fullness sensation reached level 5.|Day 14, approximately 30 minutes after liquid meal|||mL||Standard Error|Mean
661773|NCT01833988|Secondary|Difference Between Closed-loop and Open-loop in Area Over the Curve and Below 70 mg/dl (Measure of Total Hypoglycemia Exposure) at Night||1 week|"This outcome was not analyzed as we feel that the outcome percentage of time <70mg/dl at nightime is an equivalent indicator of overnight hypoglycemia exposure instead of area over the curve, and can be used to compare outcomes with other studies."|||||
661748|NCT01834404|Primary|Volume to Fullness|At visit 5, subjects did a satiation/nutrient drink test. Participants recorded their sensations every 5 minutes using a numerical scale from 0-5, with level 0 being no symptoms, level 3 corresponding to fullness sensation after a typical meal, and level 5 corresponding to the maximal tolerated volume (maximum or unbearable fullness/satiation). This measure was the volume consumed when the fullness sensation reached level 3.|Day 14, approximately 30 minutes after liquid meal|||mL||Standard Error|Mean
661749|NCT01834404|Primary|Postprandial Gastric Volume|Postprandial gastric volume was measured by 99mTc-SPECT Imaging. Subjects reported to the clinic after an overnight fast. 99mTC was given by an intravenous injection in the forearm. After the liquid meal tomographic images of the gastric wall were obtained throughout the long axis of the stomach using a dual-head gamma camera that rotates around the body. This allows assessment of the radiolabeled circumference of the gastric wall, rather than the intragastric content.|Day 13, approximately 30 minutes after liquid meal|||mL||Standard Error|Mean
661750|NCT01834404|Primary|Fasting Gastric Volume|Fasting whole gastric volume was measured by Technetium (99mTc)-SPECT Imaging. Subjects reported to the clinic after an overnight fast. 99mTC was given by an intravenous injection in the forearm. Tomographic images of the gastric wall were obtained throughout the long axis of the stomach using a dual-head gamma camera that rotates around the body. This allows assessment of the radiolabeled circumference of the gastric wall, rather than the intragastric content.|Day 13, approximately 10 minutes after Technetium (99mTC) injection|||mL||Standard Error|Mean
661751|NCT01834404|Secondary|Solid Gastric Emptying: Proportion of Meal Emptied at 2 Hours|At visit 6 subjects took part in a gastric emptying by scintigraphy test. Subjects were given a scrambled egg breakfast with toast and a glass of milk. The eggs and milk contained a small amount of radioactive substance. At the completion of the meal, subjects stood in front of a special camera and pictures were taken at specific intervals. This outcome measure is the proportion of the radiolabeled meal emptied at 2 hours.|Day 15, approximately 2 hours after radiolabeled meal was ingested|||proportion of meal emptied||Standard Error|Least Squares Mean
661752|NCT01834404|Primary|Gastric Emptying of Solids Half-Time (T 1/2)|Gastric emptying of solids half-time is defined as the time for half of the ingested solids to leave the stomach. At visit 6 subjects took part in a gastric emptying by scintigraphy test. Subjects were given a scrambled egg breakfast with toast and a glass of milk. The eggs and milk contained a small amount of radioactive substance. At the completion of the meal, subjects stood in front of a special camera and pictures were taken at specific intervals.|Day 15, approximately 2 hours after radiolabeled meal was ingested|||minutes||Standard Error|Mean
661753|NCT01834274|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|The change between FPG collected at week 24 or final visit relative to Baseline. A negative change from Baseline indicated improvement.|Baseline and Week 24|All randomized participants with data available for analysis.||mmol/L||Standard Deviation|Mean
661754|NCT01834274|Secondary|Percentage of Participants With HbA1c <7% at Week 24|The percentage of participants with glycosylated hemoglobin less than 7% after 24 weeks of treatment.|Week 24|As pre-defined in the SAP, no summary is provided for the secondary efficacy endpoint incidence of HbA1c <7% at Week 24 due to the limited enrollment and study duration at the time of study termination.|||||
661755|NCT01834274|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 24 or final visit relative to Baseline. A negative change from Baseline indicated improvement.|Baseline and Week 24|All randomized participants with data available for analysis.||Percent||Standard Deviation|Mean
661756|NCT01834261|Secondary|Functional Connectivity Between OFC and AMY|"During functional scans, subjects participated in an interactive neuroeconomic game, an iterative version of the classical “Trust Study.” Subjects participated in an interactive neuroeconomic game, an iterative version of the classical Trust Study. During this game, the subject ('investor') is first provided a sum of money (20 units). He then has the choice in terms of how much to invest in a fictional computer-generated trustee. The trustee then sends some percentage back to the subject ('investor'), and the game iterates over 20 trials (rounds).
Using Dynamical Causal Modeling (DCM) we modeled the dynamic interaction between amygdala (AMY), nucleus accumbens (NAcc) and the orbitofrontal cortex (OFC). We observed altered connectivity strength between AMY and OFC under OT as compared to PL conditions."|Within two weeks of enrollment completion.|Healthy adult men (17 subjects completed the task fMRI (Trust Study) at MGH, remaining 3 subjects at MGH did not complete the task). The values reported for connections strengths below (0.45 and 0.18) are from the Bayesian Parameter Averaging. The measure of precision is the associated posterior probability, which is 1 for both.||Hz||Standard Deviation|Mean
661757|NCT01834261|Primary|Number of Malevolent Rounds|"This study recruited healthy adults. Subjects participated in an interactive neuroeconomic game, an iterative version of the classical Trust Study. During this game, the subject ('investor') is first provided a sum of money (20 units). He then has the choice in terms of how much to invest in a fictional computer-generated trustee. The trustee then sends some percentage back to the subject ('investor'), and the game iterates over 20 trials (rounds). We computed the investment ratio as the ratio of the actual investment and the maximum allowed amount of 20 units, and analogously for the repayment ratio. Malevolent rounds were defined as those with decreased investment ratios even after an increased repayment ratio."|Immediately after completion of the study, for each subject.|Healthy adult men.||number of rounds||Standard Deviation|Mean
661758|NCT01834261|Primary|Number of Benevolent Rounds|"This study recruited healthy adults. Subjects participated in an interactive neuroeconomic game, an iterative version of the classical Trust Study. During this game, the subject ('investor') is first provided a sum of money (20 units). He then has the choice in terms of how much to invest in a fictional computer-generated trustee. The trustee then sends some percentage back to the subject ('investor'), and the game iterates over 20 trials (rounds). We computed the investment ratio as the ratio of the actual investment and the maximum allowed amount of 20 units, and analogously for the repayment ratio. Benevolent rounds were defined as those with increased investment ratios even after a decreased repayment ratio."|Immediately after completion of the study, for each subject.|Healthy adult men.||number of rounds||Standard Deviation|Mean
661774|NCT01833988|Secondary|Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Fraction of Time Spent Within CGMG Ranges (< 70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, > 180 mg/dl, > 250 mg/dl) at Night||1 week|||percentage of time||Standard Deviation|Mean
661759|NCT01834222|Primary|Percentage of Adverse Events (AEs) With Their Causal Relationship to Study Drug|Criteria: a)Certain: followed a reasonable time sequence from administration of drug; unexplained by other drugs, chemical substance or accompanying diseases;had clinically reasonable reaction on cessation of drug; had pharmacological or phenomenological reaction to re-administration of drug, b)Probable: followed a reasonable time sequence from administration of the drug; unexplained by other drugs;chemical substance or accompanying diseases; had clinically reasonable reaction on cessation of the drug, c)Possible:followed a reasonable time sequence from administration of drug; can also be explained by other drugs;chemical substance or accompanying diseases; lacks information or had unclear information on discontinuation of drug, d)Unlikely:not likely to had a reasonable causal relationship from administration of drug; seemed temporary; can also be reasonably explained by other drugs; chemical substances or latent diseases; conditional (need more data for true assessment),unaccessible.|Baseline (Day 1) up to Day 29|"Safety analysis set included all participants who received at least 1 dose of Prevenar 13. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."||percentage of adverse events|||Number
661760|NCT01834222|Primary|Number of Participants Who Discontinued Due to Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|Baseline (Day 1) up to Day 29|"Safety analysis set included all participants who received at least 1 dose of Prevenar 13. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."||participants|||Number
661761|NCT01834222|Primary|Number of Participants With Outcome in Response to Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Outcome of an AE was assessed among participants based on their response to a question ‘Is the adverse event still present?’ as ‘yes’, ‘unknown’ or ‘no (resolved)' during study.|Baseline (Day 1) up to Day 29|"Safety analysis set included all participants who received at least 1 dose of Prevenar 13. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."||participants|||Number
661762|NCT01834222|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) by Severity|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed on basis of severity as follows: a) mild: did not caused any significant problem to the participant; b) moderate: caused problem that did not interfere significantly with usual activities or the clinical status, other therapy needed due to AE; c) severe: caused problem that interfered significantly with usual activities or the clinical status.|Baseline (Day 1) up to Day 29|Safety analysis set included all participants who received at least 1 dose of Prevenar 13.||participants|||Number
661763|NCT01834222|Primary|Duration of Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Duration of adverse event (in days) was defined as total time from onset of adverse event till the event was resolved during study.|Baseline (Day 1) up to Day 29|Safety analysis set included all participants who received at least 1 dose of Prevenar 13.||days||Standard Deviation|Mean
661764|NCT01834222|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose (up to Day 29) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non­serious AE.|Baseline (Day 1) up to Day 29|Safety analysis set included all participants who received at least 1 dose of Prevenar 13.||participants|||Number
661765|NCT01834027|Secondary|Mean Blood Pressure|non-invasive mean blood pressure will be measured every 5 minutes for a period of 60 minutes|60 minutes||||||
661766|NCT01834027|Secondary|Mean Difference in Patient's Perception of Pain From Baseline|The patient will be asked to rate her level of pain using a numeric rating scale from 0-10 (0 indicates no pain and 10 indicates extreme pain). Baseline will be value upon entering PACU. The difference between the values at specific times and the baseline value will be calculated.|10, 20 , and 30 minutes after baseline measurement|||units on a scale||95% Confidence Interval|Mean
661767|NCT01834027|Secondary|Difference in Patient's Perception of Anxiety From Baseline Score Upon Arrival in the PACU|Upon arrival in the PACU, patient will be asked to rate her level of anxiety using a numeric rating scale from 0-10 (0 indicates no anxiety while 10 indicates extreme anxiety). After wearing headphones for 30 minutes, with either jazz music or no music, the patient will reassess her anxiety level. The difference between the 30 minute score and the baseline will be calculated.|Once, at 30 minutes after the patient entered the PACU|2 participants in the jazz group nad 1 participant in the no music group did not provide an anxiety score.||units on a scale||Standard Deviation|Mean
661768|NCT01834027|Primary|Change in Heart Rate From Baseline on Arrival in PACU|Mean difference in heart rate from baseline measurement taken upon the patient's arrival to the PACU. Heart rate will be measured through pulse oximetry|5, 10, 15, 20, 25, 30 minutes after baseline measurement on patient's arrival in PACU|||beats per minute||95% Confidence Interval|Mean
661769|NCT01833988|Other Pre-specified|Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Mean Insulin Total Daily Dose||1 week|||unit/kg/day||Standard Deviation|Mean
661770|NCT01833988|Secondary|Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Number of Carbohydrate Interventions for Hypoglycemia at Night||1 week|||interventions|||Number
661771|NCT01833988|Secondary|Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Number of Carbohydrate Interventions for Hypoglycemia||1 week|||number of interventions|||Number
661772|NCT01833988|Secondary|Difference Between Closed-loop and Open-loop in Area Over the Curve and Below 50 mg/dl (Measure of Total Hypoglycemia Exposure) at Night||1 week|"This outcome was not analyzed as we feel that the outcome percentage of time <50mg/dl at nightime is an equivalent indicator of severe overnight hypoglycemia exposure instead of area over the curve, and can be used to compare outcomes with other studies."|||||
661780|NCT01833988|Secondary|Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Standard Deviation of CGMG Values (Glycemic Variability) in Different BG Ranges.|"Difference between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in standard deviation of CGMG values (glycemic variability) in different BG ranges.
%<70 70–120 70–180 %>180 %>250"|1 week|||Standard deviation of mean values|||Number
661781|NCT01833988|Secondary|Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Mean CGMG During Exercise||1 week|Data not obtained for exercise period|||||
661782|NCT01833988|Secondary|Difference Between Closed-loop and Open-loop in Mean CGMG in the Four Hour Period Following Meals||1 week|Data was not collected to measure this outcome|||||
661783|NCT01833988|Secondary|Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Number of Subjects With Mean CGMG < 154 mg/dl||1 week|||Participants|||Count of Participants
661784|NCT01833988|Secondary|Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Area Over the Curve and Below 50 mg/dl (Measure of Total Hypoglycemia Exposure)||1 week|"This outcome was not analyzed as we feel that the outcome percentage of time <50mg/dl is a n equivalent indicator of severe hypoglycemia instead of area over the curve, and can be used to compare outcomes with other studies."|||||
661785|NCT01833988|Secondary|Difference Between Closed-loop and Open-loop in Area Over the Curve and Below 70 mg/dl (Measure of Total Hypoglycemia Exposure)||1 week|"This outcome was not analyzed as we feel that the outcome percentage of time <70mg/dl is an equivalent indicator of hypoglycemia exposure instead of area over the curve, and can be used to compare outcomes with other studies."|||||
661786|NCT01833988|Secondary|Difference Between Closed-loop (Bionic Pancreas) and Open-loop (Insulin Pump) in Mean Continuous Glucose Monitoring Glucose (CGMG)|Day 2-5|Day 2-5|||mg/dl||Standard Deviation|Mean
661787|NCT01833988|Secondary|Difference in Mean CGMG on Day 1 vs. Remaining Days (Days 2-5) Between Closed Loop (Bionic Pancreas Arm) and Usual Care (Insulin Pump Arm)||1 week|||mg/dl||Standard Deviation|Mean
661788|NCT01833988|Secondary|Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Number of Severe Hypoglycemic Episodes and Nadir BG During Exercise||1 week|Individual data during exercise was not analyzed. No episodes of severe hypoglycemia were observed on bionic pancreas and only 1 episode of severe hypoglycemia occurred in usual care arm (insulin pump)||Participants|||Count of Participants
661789|NCT01833988|Secondary|Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Mean BG During Exercise||1 week|Data on exercise not collected|||||
661790|NCT01833988|Secondary|Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Fraction of Time Spent Within CGMG (Continuous Glucose Monitor) Ranges (< 70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, > 180 mg/dl, > 250 mg/dl)||1 week|Fraction of time < 70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, > 180 mg/dl, > 250 mg/dl||percentage of time||Standard Deviation|Mean
661791|NCT01833988|Secondary|Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Number of Hypoglycemic Events (BG <70mg/dl) as Determined From HemoCue Measurements||Day 1-5|||events|||Number
661792|NCT01833988|Secondary|Difference in the Percentage of Study Days With Mean CGM BG </= 154 mg/dl Over the Duration of the Closed-loop Period vs. the Usual Care Period||Day 2-5|||percentage of days||Standard Deviation|Mean
661793|NCT01833988|Secondary|Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Number of Subjects With Mean BG < 154 mg/dl||Day 2-5|||Participants|||Count of Participants
661794|NCT01833988|Secondary|Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Average BG as Determined From All HemoCue Measurements Taken During the Day/Nighttime Including All Extra Measurements.|Difference between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in average BG as determined from all HemoCue measurements taken during the day/nighttime including all extra measurements taken before meals, taken during exercise, and taken for hypoglycemia monitoring.|1 week|This data was not analysed to prevent bias. This information would have been misleading (unscheduled BG checks were performed to confirm a low BG mostly). Overall CGM trend, incidence/duration of hypoglycemia and BG trend during and after exercise is separately analyzed under other secondary outcomes.|||||
661795|NCT01833988|Primary|Percentage of Time With a Low Plasma Glucose Reading (Less Than 70mg/dl) in the Bionic Pancreas Arm as Compared to Insulin Pump Arm||1 week|||percentage of time||Standard Deviation|Mean
661796|NCT01833988|Primary|Difference in Average Blood Glucose (BG) Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) Periods as Determined From All Scheduled HemoCue Measurements With Mean Evenly Weighted Across the Daytime and Nighttime Hours.||1 week|||mg/dL||Standard Deviation|Mean
661797|NCT01833897|Secondary|Beck's Depression Inventory|Range 0-63, with higher scores worse. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.|8 weeks|||units on a scale (final score)||Standard Deviation|Mean
661798|NCT01833897|Secondary|Hamilton Anxiety Scale|Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0–56, where <17 indi- cates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe.|8 weeks|||units on a scale (final score)||Standard Deviation|Mean
661799|NCT01833897|Secondary|HAM-D Suicide Item|Ham-D suicide item: range 0-4, higher scores indicate worse symptoms|8 weeks|||units on a scale (final)||Standard Deviation|Mean
661800|NCT01833897|Secondary|Loss of Motivated Behavior HAM-D Factor|includes the total of four HAM-D items: (Item 7: Work and activities, Item 12. Somatic symptoms (appetite), Item 14. Genital symptoms (libido), and Item 16. Weight loss). Range 0-11, higher scores indicate worse symptoms|8 weeks|bipolar depression||units on a scale (final score)||Standard Deviation|Mean
661801|NCT01833897|Primary|Hamilton Depression Rating Scale (HAM-D)|"Depression rating scale: Range 0-53, higher scores indicate worse depression. 0-7 = Normal 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severe Depression
≥ 23 = Very Severe Depression"|8 weeks|bipolar depression||units on a scale (final score)||Standard Deviation|Mean
661802|NCT01833845|Secondary|Efficacy|To evaluate the efficacy of 8 weeks monotherapy with RBV in HCV-infected patients.|8 weeks||||||
661803|NCT01833845|Primary|Safety: Number of Participants With Adverse Events|Safety was assessed throughout study by collection of adverse event and concomitant medication data, and routine monitoring of lab safety tests, physical exams, ophthalmic examination, vital signs and 12 lead electrocardiograms.|all 24 weeks|||participants|||Number
661805|NCT01833741|Primary|Percentage of Patients Treated With Adjunctive Therapy With Ocular Hyperemia|Hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). Hyperemia is graded on a 5 point scale where 0=none (normal), 0.5=trace (trace flush reddish pink), 1=Mild (mild flush reddish color), 2=Moderate (bright red color) and 3=severe (deep bright diffuse redness). Previously treated patients used glaucoma medication prior to study entry and added study treatment as adjunctive therapy.|Week 12|All patients who were consented and completed the Baseline visit, and who had data for Week 12||Percentage of Patients|||Number
661806|NCT01833741|Primary|Percentage of Previously Treated (Switched) Patients With Ocular Hyperemia|Hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). Hyperemia is graded on a 5 point scale where 0=none (normal), 0.5=trace (trace flush reddish pink), 1=Mild (mild flush reddish color), 2=Moderate (bright red color) and 3=severe (deep bright diffuse redness). Previously treated patients used glaucoma medication prior to study entry and were switched from their previous therapy to study treatment.|Week 12|All patients who were consented and completed the Baseline visit, and who had data for Week 12||Percentage of Patients|||Number
661807|NCT01833741|Secondary|Percentage of Patients Discontinuing Due to Ocular Adverse Events|Ocular adverse events are defined as any untoward medical occurrence in a patient's eye(s) during study participation, regardless of relationship to treatment.|12 Weeks|Intent to Treat: all patients who were consented and completed the Baseline visit||Percentage of Patients|||Number
661808|NCT01833741|Secondary|Change From Baseline in IOP in the Study Eye of Patients Treated With Adjunctive Therapy|IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening).|Baseline, Week 6, Week 12|Intent to Treat: all patients who were consented and completed the Baseline visit||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
661809|NCT01833741|Secondary|Change From Baseline in IOP in the Study Eye of Previously Treated (Switched) Patients|IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening).|Baseline, Week 6, Week 12|Intent to Treat: all patients who were consented and completed the Baseline visit||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
661810|NCT01833741|Secondary|Change From Baseline in IOP in the Study Eye of Treatment-Naive Patients|IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening).|Baseline, Week 6, Week 12|Intent to Treat: all patients who were consented and completed the Baseline visit||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
661811|NCT01833741|Secondary|Percent Change From Baseline in IOP in the Study Eye of Patients Treated With Adjunctive Therapy|IOP is a measurement of the fluid pressure inside the eye. Previously treated patients used glaucoma medication prior to study entry and added study treatment as adjunctive therapy. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening).|Baseline, 12 Weeks|Intent to Treat: all patients who were consented and completed the Baseline visit||Percent Change||Standard Deviation|Mean
661812|NCT01833741|Secondary|Percent Change From Baseline in IOP in the Study Eye of Previously Treated (Switched) Patients|IOP is a measurement of the fluid pressure inside the eye. Previously treated patients used glaucoma medication prior to study entry and were switched from their previous therapy to study treatment. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening).|Baseline, 12 Weeks|Intent to Treat: all patients who were consented and completed the Baseline visit||Percent Change||Standard Deviation|Mean
661813|NCT01833741|Secondary|Percent Change From Baseline in Intraocular Pressure (IOP) in the Study Eye of Treatment-Naive Patients|IOP is a measurement of the fluid pressure inside the eye. Naive patients did not use glaucoma medication prior to study entry. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening).|Baseline, 12 Weeks|Intent to Treat: all patients who were consented and completed the Baseline visit||Percent Change||Standard Deviation|Mean
661814|NCT01833741|Primary|Percentage of Treatment-Naive Patients With Ocular Hyperemia|Hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). Hyperemia is graded on a 5 point scale where 0=none (normal), 0.5=trace (trace flush reddish pink), 1=Mild (mild flush reddish color), 2=Moderate (bright red color) and 3=severe (deep bright diffuse redness). Naive patients did not use glaucoma medication prior to study entry.|Week 12|All patients who were consented and completed the Baseline visit, and who had data for Week 12||Percentage of Patients|||Number
661815|NCT01833533|Secondary|Percentage of Participants With Virologic Relapse After Treatment|Participants who completed treatment with plasma HCV RNA less than the lower limit of quantification (<LLOQ) at the end of treatment were considered to have virologic relapse if they had confirmed HCV RNA ≥ LLOQ during the post-treatment period. 95% CI calculated using the normal approximation to the binomial distribution.|Between End of Treatment (Week 12) and Post-treatment (up to Week 12 Post-Treatment)|All randomized participants who received at least 1 dose of study drug (ITT population) with HCV RNA < LLOQ at the final treatment visit and completed treatment.||percentage of participants||95% Confidence Interval|Number
661816|NCT01833533|Secondary|Percentage of Participants With Virologic Failure During Treatment|Virologic failure during treatment was defined as rebound (confirmed HCV RNA greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA < LLOQ during treatment, or confirmed increase from the lowest value post baseline in HCV RNA [2 consecutive HCV RNA measurements > 1 log10 IU/mL above the lowest value post baseline] at any time point during treatment), or failure to suppress (HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks [≥ 36 days] of treatment).|Baseline (Day 1), and Treatment Weeks 1, 2, 4, 6, 8, 10, and 12|All randomized participants who received at least 1 dose of study drug (ITT population).||percentage of participants|||Number
661885|NCT01832155|Other Pre-specified|Feasibility Measures - Retention|Feasibility was measured by the retention rate during the 8 weeks program. Data from both intervention and wait-list control (during their treatment period) groups were collected. Participants' class attendance (average number of classes attended) was evaluated.|8 weeks|||classes||Full Range|Mean
661817|NCT01833533|Secondary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Secondary Analyses|"The percentage of participants with sustained virologic response (plasma HCV RNA less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.
The secondary efficacy endpoints were superiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333, plus either placebo RBV or RBV) compared with the historical control rate for noncirrhotic, treatment-naïve participants with HCV GT1a infection treated with telaprevir and pegIFN/RBV; and the noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment who received ABT-450/r/ABT-267 and ABT-333, plus placebo RBV compared with those who received ABT-450/r/ABT-267 and ABT-333, plus RBV."|12 weeks after last dose of study drug|All randomized participants who received at least 1 dose of study drug (ITT population); participants with missing data were counted as non-responders.||percentage of participants|||Number
661818|NCT01833533|Secondary|Percentage of Participants With Hemoglobin Decrease to Below the Lower Limit of Normal (LLN) At End of Treatment|The percentage of participants with a decrease in hemoglobin from greater than or equal to the lower limit of normal (≥ LLN) at baseline to < LLN at the end of treatment.|Baseline (Day 1) and Week 12 (End of Treatment)|All randomized participants who received at least 1 dose of study drug (ITT population) and had hemoglobin ≥ LLN reference range at baseline.||percentage of participants|||Number
661819|NCT01833533|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Primary Analyses|"The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug. The LLOQ for the assay was 25 IU/mL.
The primary efficacy endpoints were noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333, plus either placebo RBV or RBV) compared with the historical control rate for noncirrhotic, treatment-naïve participants with HCV GT1a infection treated with telaprevir and peginterferon(pegIFN)/RBV."|12 weeks after last dose of study drug|All randomized participants who received at least 1 dose of study drug (intent-to-treat [ITT] population); participants with missing data were counted as non-responders.||percentage of participants|||Number
661820|NCT01833481|Primary|Kinematics - Overall Separation|Determine overall hip separation present in vivo in implanted hip during level walking activity under fluoroscopic surveillance|6 months post-operative|||mm||Standard Deviation|Mean
661821|NCT01833481|Primary|Kinematics - Stance Phase Separation|Determine amount of stance phase hip separation present in vivo of implanted hip during level walking activity under fluoroscopic surveillance.|6 months post-operative|||mm||Standard Deviation|Mean
661822|NCT01833481|Primary|Kinematics - Swing Phase Separation|Determine amount of in vivo swing phase hip separation present within implanted hip during weight-bearing level walking while under fluoroscopic surveillance.|6 months post-operatively|||mm||Standard Deviation|Mean
661823|NCT01833403|Primary|Insulin Sensitivity|Insulin sensitivity was assessed during the euglycemic/hyperglycemic clamp test. Insulin-mediated glucose uptake (M-value) was calculated as the mean glucose requirement during the 150-180 minute interval of the clamp|1 month|||mg glucose /kg FFM/min||Standard Error|Mean
661824|NCT01833403|Primary|Insulin Sensitivity||Baseline|||m value||Standard Deviation|Mean
661825|NCT01833247|Post-Hoc|Salivary and Capillary Lactic Acid Will be Correlated After a Seizure|Salivary levels of lactic acid is being studied because saliva is more accessible in the outpatient setting than is blood. Concentration of lactic acid in the serum and saliva from each individual subject will be correlated using Pearson's correlation test. We will consider a positive outcome to be a r greater than or equal to 0.5 and significance at p<0.05.|Within 10 minutes of a seizure||||||
661826|NCT01833247|Primary|Intravenous Lactic Acid Levels With Seizures|The investigators will assess the intravenous lactic acid within 10 minutes after end of a seizure. Values will consist of lactic acid measurements in serum collected by IV, immediately post-seizure. Units of measurement will be mM/L. A positive outcome will be a curve different from a straight line, with a rise and fall of lactate levels. Baseline lactate serum level is expected to be less than 2.2 mM/L.|Within 10 minutes of end of the seizure|Data were collected from one participant||mmol/L|||Number
661827|NCT01833247|Primary|Capillary Lactic Acid Levels With Seizures|The investigators will assess the capillary lactic acid within 10 minutes after end of a seizure. Values will consist of lactic acid measurements in blood, within 10 minutes after the end of a seizure. Units of measurement will be mM/L. Baseline lactate serum level is expected to be less than 2.2 mM/L.|Within 10 minutes of end of the seizure|Data were collected from 6 of the 12 enrolled subjects||mmol/L||Standard Deviation|Mean
661828|NCT01833247|Primary|Salivary Lactic Acid Levels With Seizures|The investigators will assess the salivary lactic acid within 10 minutes after end of a seizure. Values will consist of lactic acid measurements in saliva , immediately post-seizure. Units of measurement will be mM/L. A positive outcome will be a curve different from a straight line, with a rise and fall of lactate levels. Baseline lactate serum level is expected to be less than 2.2 mM/L.|Within 10 minutes of end of the seizure|||mmol/L||Standard Deviation|Mean
661829|NCT01833130|Secondary|Change From Baseline in the Emotional Function (EF) Domain of the MSQ|The MSQ is 14 question scale that measures health-related impairments attributed to migraines over the past 4 weeks. The EF domain score ranges from 0 (no symptoms) to 100 (symptoms experienced all the time). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the EF.|Baseline, Week 24|Intent-to-Treat: all randomized patients||Scores on a Scale||Standard Deviation|Mean
661830|NCT01833130|Secondary|Change From Baseline in the Role Function-Preventive (RP) Domain of the MSQ|The MSQ is 14 question scale that measures health-related impairments attributed to migraines over the past 4 weeks. The RP domain score ranges from 0 (no symptoms) to 100 (symptoms experienced all the time). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the RP.|Baseline, Week 24|Intent-to-Treat: all randomized patients||Scores on a Scale||Standard Deviation|Mean
661886|NCT01832155|Secondary|Absolute Value of BMI at 8 Weeks|BMI was calculated using the participant's weight and height, kg/m^2.|8 weeks|||kg/m^2||Standard Error|Mean
666034|NCT01763905|Secondary|Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
661831|NCT01833130|Secondary|Change From Baseline in the Role Function-Restrictive (RR) Domain of the Migraine Specific Questionnaire (MSQ)|The MSQ is 14 question scale that measures health-related impairments attributed to migraines over the past 4 weeks. The RR domain score ranges from 0 (no symptoms) to 100 (symptoms experienced all the time). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the RR.|Baseline, Week 24|Intent-to-Treat: all randomized patients||Scores on a Scale||Standard Deviation|Mean
661832|NCT01833130|Secondary|Change From Baseline in the Headache Impact Test-6 (HIT-6) Questionnaire Total Score|The HIT-6 is a 6 question 5-point scale used to measure the impact of headaches on daily life. The total score ranged from 36 (no impact) to 78 (worst impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening.|Baseline, Week 24|Intent-to-Treat: all randomized patients||Scores on a Scale||Standard Deviation|Mean
661833|NCT01833130|Secondary|Change From Baseline in the General Impact (GEN-I) Domain of the ACM-I Questionnaire|The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The GEN-I is a subdomain on the ACM-I. The GEN-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the GEN-I.|Baseline, Week 12, Week 22, Week 24|Intent-to-Treat: all randomized patients||Scores on a Scale||Standard Deviation|Mean
661834|NCT01833130|Secondary|Change From Baseline in the Cognitive Impact (COG-I) Domain of the ACM-I Questionnaire|The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The COG-I is a subdomain on the ACM-I. The COG-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the COG-I.|Baseline, Week 12, Week 22, Week 24|Intent-to-Treat: all randomized patients||Scores on a Scale||Standard Deviation|Mean
661835|NCT01833130|Secondary|Change From Baseline in the Energy Impact (ENE-I) Domain of the ACM-I Questionnaire|The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The ENE-I is a subdomain on the ACM-I. The ENE-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the ENE-I.|Baseline, Week 12, Week 22, Week 24|Intent-to-Treat: all randomized patients||Scores on a Scale||Standard Deviation|Mean
661836|NCT01833130|Secondary|Change From Baseline in the Household Activities Impact (HOS-I) Domain of the ACM-I Questionnaire|The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The HOS-I is a subdomain on the ACM-I. The HOS-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the HOS-I.|Baseline, Week 12, Week 22, Week 24|Intent-to-Treat: all randomized patients||Scores on a Scale||Standard Deviation|Mean
661837|NCT01833130|Secondary|Change From Baseline in the Leisure Activities Impact (LEA-I) Domain of the ACM-I Questionnaire|The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The LEA-I is a subdomain on the ACM-I. The LEA-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the LEA-I.|Baseline, Week 12, Week 22, Week 24|Intent-to-Treat: all randomized patients||Scores on a Scale||Standard Deviation|Mean
661838|NCT01833130|Secondary|Change From Baseline in the Social Impact (SOC-I) Domain of the ACM-I Questionnaire|The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The SOC-I is a subdomain on the ACM-I. The SOC-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the SOC-I.|Baseline, Week 12, Week 22, Week 24|Intent-to-Treat: all randomized patients||Scores on a Scale||Standard Deviation|Mean
661839|NCT01833130|Secondary|Change From Baseline in the Work/School Impact (WS-I) Domain of the ACM-I Questionnaire|The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The WS-I is a subdomain on the ACM-I. The WS-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the WS-I.|Baseline, Week 12, Week 22, Week 24|Intent-to-Treat: all randomized patients||Scores on a Scale||Standard Deviation|Mean
661840|NCT01833130|Secondary|Change From Baseline in the Emotions Impact (EMO-I) Domain of the ACM-I Questionnaire|The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The EMO-I is a subdomain on the ACM-I. The EMO-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the EMO-I.|Baseline, Week 12, Week 22, Week 24|Intent-to-Treat: all randomized patients||Scores on a Scale||Standard Deviation|Mean
661841|NCT01833130|Secondary|Change From Baseline in the Activities of Daily Living Impact (ADL-I) Domain of the ACM-I Questionnaire|The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The ADL-I is a subdomain on the ACM-I. The ADL-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the ADL-I.|Baseline, Week 12, Week 22, Week 24|Intent-to-Treat: all randomized patients||Scores on a Scale||Standard Deviation|Mean
661842|NCT01833130|Secondary|Change From Baseline in the Symptom Experience Score (SES) Subdomain of the ACM-S Questionnaire|The ACM-S is 12 question migraine symptom scale over the past 24 hours. The SES subdomain score ranges from 0 (no symptoms) to 12 (all symptoms experienced). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the ACM-S SES.|Baseline, Week 24|Intent-to-Treat: all randomized patients||Scores on a Scale||Standard Deviation|Mean
666035|NCT01763905|Secondary|Percent Change From Baseline in Triglycerides at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
661843|NCT01833130|Secondary|Change From Baseline in the Symptom Severity Score (SSS) Subdomain of the Assessment of Chronic Migraine Symptoms (ACM-S) Questionnaire|The ACM-S is 12 question migraine symptom scale over the past 24 hours. The SSS subdomain score ranges from 0 (no symptoms) to 100 (more severe symptoms). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the ACM-S SSS.|Baseline, Week 24|Intent-to-Treat: all randomized patients||Scores on a Scale||Standard Deviation|Mean
661844|NCT01833130|Primary|Change From Baseline in the Assessment of Chronic Migraine Impacts (ACM-I) Questionnaire Total Score|The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The total score ranged from 0 (lower impact chronic migraine) to 100 (highest impact chronic migraine). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening.|Baseline, Week 24|Intent-to-Treat: all randomized patients||Scores on a Scale||Standard Deviation|Mean
661845|NCT01833117|Secondary|Area Under Curve (AUC) of TBUT From 0 to 60 Minutes|Fluorescein dye was instilled in the eye to assess tear break-up time. After instillation of the fluorescein, the subject was instructed to blink 3 times, then stare and not blink. The investigator measured the time from the last blink until the first black (dry) spot appeared in the precorneal tear film. Tear break-up time was assessed prior to test article instillation (baseline) and at 5, 15, 30, and 60 minutes. Three consecutive measurements were taken per eye at each time point, with the average of the 3 scores being the value analyzed. An increase in total score equates to improvement. One eye was chosen as the study eye and only data for the study eye were used.|0 to 60 minutes|This analysis population includes all randomized participants.||seconds x hours||Standard Deviation|Mean
661846|NCT01833117|Primary|Mean Change From Baseline in Tear Break-up Time (TBUT) at 60 Minutes|Fluorescein dye was instilled in the eye to assess tear break-up time. After instillation of the fluorescein, the subject was instructed to blink 3 times, then stare and not blink. The investigator measured the time from the last blink until the first black (dry) spot appeared in the precorneal tear film. Tear break-up time was assessed prior to test article instillation (baseline) and at 60 minutes. Three consecutive measurements were taken per eye at each time point, with the average of the 3 scores being the value analyzed. An increase in total score equates to improvement. One eye was chosen as the study eye and only data for the study eye were used.|Baseline, 60 minutes|This analysis population includes all randomized participants.||seconds||Standard Error|Mean
661847|NCT01833078|Secondary|Sustainability of Increased Caloric Intake|Sustained food intake of standardized meal from Days 1 compared to Day 7.|pre-treatment baseline (day 1) through day 7|||calories||Full Range|Median
661848|NCT01833078|Primary|Safety|1.Safety: # of participants with treatment emergent adverse events|pre-treatment baseline through 30 days following the last administration of study treatment day 7|||participants|||Number
661849|NCT01833065|Secondary|Change From Baseline in Weekly Abdominal Discomfort Score|"The abdominal discomfort score was measured using the five-point ordinal scale (1=None, 2=Mild, 3=Moderate, 4=Severe, and 5=Very severe).
For a given assessment week, the weekly abdominal discomfort score was defined as the sum of non-missing abdominal discomfort score for SBMs during that week divided by the number of non-missing abdominal discomfort score for SBMs during that week. The parameter was analysed using repeated measures ANCOVA model."|From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period|The ITT analysis set consisting of all randomized (as planned) patients.||Units on a scale||95% Confidence Interval|Least Squares Mean
661850|NCT01833065|Secondary|Change From Baseline in Weekly Abdominal Bloating Score|"The abdominal pain score was measured using the five-point ordinal scale (1=None, 2=Mild, 3=Moderate, 4=Severe, and 5=Very severe).
For a given assessment week, the weekly abdominal bloating score was defined as the sum of non-missing abdominal bloating score for SBMs during that week divided by the number of non-missing abdominal bloating score for SBMs during that week. The parameter was analysed using repeated measures ANCOVA model."|From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period|The ITT analysis set consisting of all randomized (as planned) patients.||Units on a scale||95% Confidence Interval|Least Squares Mean
661851|NCT01833065|Secondary|Change From Baseline in Weekly Degree of Straining of SBMs|"The degree of straining was measured using the five-point ordinal scale (1=Not at all, 2=A little bit, 3=A moderate amount, 4=A great deal, and 5=An extreme amount).
For a given assessment week, the weekly degree of straining was defined as the sum of non-missing straining score for SBMs during that week divided by the number of non-missing straining score for SBMs during that week. The parameter was analysed using repeated measures ANCOVA model."|From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period|The ITT analysis set consisting of all randomized (as planned) patients.||Units on a scale||95% Confidence Interval|Least Squares Mean
661852|NCT01833065|Secondary|Total Patient Assessment of Constipation - Quality of Life (PAC-QOL) Score Responder|"This outcome measured the percentage of patients who were PAC-QOL score responder at 12-week Treatment Period. A PAC-QOL score responder was defined as a patient with ≥50% reduction in total PAC-QOL score from Baseline at Week 12.
PAC-QOL is a 28-item questionnaire for psychometric assessment of disease-specific quality of life. The questionnaire is based on 5-point Likert scale; ranging from 0 [none of the time or not at all] to 4 [all of the time or extremely]). A lower score indicates a better Quality of Life. The PAC-QOL questionnaire is developed specifically for patients with constipation.
Total PAC-QOL score was averaged from the individual item score."|At Week 12|The ITT analysis set consisting of all randomized (as planned) patients.||Percentage of patients|||Number
661872|NCT01832506|Secondary|Maximum Plasma Concentration (Cmax) After Single Dose of MSC2156119J||pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|Pharmacokinetic (PK) analysis set included all subjects who had completed Cycle 1 without any relevant protocol violations with respect to factors that were likely to affect PK results and who received at least first dose of study drug according to protocol providing sufficient concentration time data to determine PK endpoints for the study drug.||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
661954|NCT01831258|Secondary|Insomnia Severity Index (Subjective Sleep Quality)|Collected through the Insomnia Severity Index (ISI). There are seven question with each question having a scale of 0 (no issue) to 4 (very severe). The total score is added up. If the participant has a total score of 0-7 = no clinical significant insomnia, total score of 8-14 = sub threshold insomnia, total score of 15-21 = clinical insomnia (moderate), total score of 22-28 = clinical insomnia (severe).|4 weeks|Data for 63 participant were available||units on a scale||Standard Error|Mean
661853|NCT01833065|Secondary|Change From Baseline in Weekly Stool Consistency of SBMs|"The stool consistency is measured using the seven-point ordinal Bristol Stool Form Scale (BSFS) score. The BSFS classifies human stool into seven types and points them accordingly.
Type 1: Separate hard lumps, like nuts (hard to pass) Type 2: Sausage-shaped, but lumpy Type 3: Like a sausage but with cracks on its surface Type 4: Like a sausage or snake, smooth and soft Type 5: Soft blobs with clear cut edges (passed easily) Type 6: Fluffy pieces with ragged edges, a mushy stool Type 7: Watery, no solid pieces, entirely liquid Types 1 and 2 indicate constipation, with 3 and 4 represents the ideal stool form (especially the latter), and 5, 6 and 7 tends towards diarrhoea .
For a given assessment week, the weekly stool consistency was defined as the sum of non-missing stool consistency score for SBMs during that week divided by the number of non-missing stool consistency score for SBMs during that week. The parameter was analysed using repeated measures ANCOVA model."|From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period|The ITT analysis set consisting of all randomized (as planned) patients.||Units on BSFS||95% Confidence Interval|Least Squares Mean
661854|NCT01833065|Secondary|Change From Baseline in Weekly Frequency of Spontaneous Bowel Movement (SBMs)|The change from Baseline for the continuous variable was estimated using a repeated measures analysis of covariance (ANCOVA) model.|From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period|The ITT analysis set consisting of all randomized (as planned) patients.||SBM per week||95% Confidence Interval|Least Squares Mean
661855|NCT01833065|Secondary|Occurrence of CSBM Response|This outcome measured the percentage of patients who had a CSBM within 24 hours after the first dose of treatment. A CSBM was defined as a spontaneous (occurring without laxative within the preceding 24 hours, including no rescue medication within the preceding 24 hours) bowel movement (as interpreted by the patient, with a beginning and an end, including single or multiple stools), accompanied by a patient reported sense of complete evacuation (‘complete’).|Within first 24 hours of treatment initiation|The ITT analysis set consisting of all randomized (as planned) patients.||Percentage of patients|||Number
661856|NCT01833065|Primary|Overall Complete Spontaneous Bowel Movement (CSBM) Response|This outcome measured the percentage of patients who were CSBM responders. A CSBM responder was defined as a patient with ≥3 CSBMs per week and an increase of ≥1 CSBM per week from Baseline, for at least 9 of the 12 weeks in the 12-week Treatment Period, including at least 3 weeks during Weeks 9-12.|During the first 12 weeks|The ITT analysis set consisting of all randomized (as planned) patients.||Percentage of patients|||Number
661857|NCT01832766|Other Pre-specified|Brief Psychiatric Rating Scale Change From Baseline at 1 Hour|Measures psychiatric symptoms. Each item is scored from 1-7. Positive symptoms are calculated from sum of scores on hallucinatory behavior, unusual thought content and conceptual disorganization. Thus, the range of Total Positive Symptoms can be from a score of 3-21 .The higher the score, the more severe the symptom. Negative symptoms have been calculated from sum of blunted affect, emotional withdrawal and motor retardation. The range of Total Negative Symptoms can be from a score of 3-21. The higher the score, the more severe the symptoms. As this is a difference from baseline, there can be either negative or positive results as the subjects can either be better than baseline (positive score) or worse than baseline (negative score).|at 1 hour after drug administration|One participant did not complete the treatment or the placebo arm (crossover study design).||units on a scale||Standard Deviation|Mean
661858|NCT01832766|Secondary|California Verbal Learning Test Change at 2 Hours From Baseline|ability to remember a list of words given 5 trials. Number of words remembered is normalized to a schizophrenia population and average scores are calculated with age correction. The normal T-score is 50 and scores greater than 50 correspond with greater ability to remember words as compared to a schizophrenia population norm.|2 hours after drug administration|One participant did not complete the treatment or the placebo arm (crossover study design).||T scores||Standard Deviation|Mean
661859|NCT01832766|Primary|P50 Auditory Evoked Potential|electrophysiological measure of ability to filter extraneous stimuli measured as the amplitude of the evoked response to the second auditory stimulus divided by the amplitude of the evoked response to the first auditory stimulus in mV.|2 hours after drug administration|One participant did not complete the treatment or the placebo arm (crossover study design).||test to conditioning ratio||Standard Deviation|Mean
661860|NCT01832506|Secondary|Progression-free Survival (PFS)|PFS was defined as the time in months from the first administration of trial treatment until first observation of progressive disease (PD), or death due to any cause when death occurs within 12 weeks of the last tumor assessment or first administration of trial treatment (whichever is later). Any subject with neither assessment of tumor progression, nor death within 12 weeks after last tumor assessment date was censored on the date of last tumor assessment. PFS was planned to be presented for “MSC2156119J Combined” reporting arm.|Day 21 of Cycle 2 and each subsequent cycle up to a maximum of 51.1 weeks|Safety analysis set included all subjects who had received at least 1 dose of the IMP.||months||90% Confidence Interval|Median
661861|NCT01832506|Secondary|Number of Subjects With Clinical Benefit|Clinical Benefit was defined as CR or PR at any time point or SD at week 12 or later, based on tumor assessment as determined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1). CR: defined as disappearance of all target and all non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: defined as at least a 30% decrease in sum of longest diameter of target lesions, taking as reference the baseline sum of longest diameter. SD: defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of longest diameter while on study. PD: defined as at least a 20% increase in sum of longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or unequivocal progression of existing non-target lesions.|Day 21 of Cycle 2 and each subsequent cycle up to a maximum of 51.1 weeks|Safety analysis set included all subjects who had received at least 1 dose of the IMP.||subjects|||Number
661883|NCT01832155|Other Pre-specified|Feasibility Measure - Acceptability|"Acceptability was evaluated by the participants' perceived difficulty of the yoga class and level of enjoyment. Upon completion of the yoga program, perceived level of program difficulty was rated by participants using a scale of 1 - 10 where 10 represents extremely difficult and a scale of 1 - 10 where 10 represents most enjoyable was used to measure perceived level of program enjoyment. Data from both intervention and wait-list control (during the intervention period) groups were collected."|8 weeks|||units on a scale||Full Range|Mean
661862|NCT01832506|Secondary|Number of Subjects With Best Overall Response (BOR)|Number of subjects with BOR in each category (complete response [CR], partial response [PR], stable disease [SD], progressive disease [PD]) according to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) was reported. CR: defined as disappearance of all target and all non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: defined as at least a 30% decrease in sum of longest diameter of target lesions, taking as reference the baseline sum of longest diameter. PD: defined as at least a 20% increase in sum of longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or unequivocal progression of existing non-target lesions. SD: defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of longest diameter while on study.|Day 21 of Cycle 2 and each subsequent cycle up to a maximum of 51.1 weeks|Safety analysis set included all subjects who had received at least 1 dose of the IMP.||subjects|||Number
661863|NCT01832506|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Sampling Time t (AUC0-t) After Multiple Dose of MSC2156119J|Area under the plasma concentration versus time curve from time zero to the last sampling time t at which the concentration is at or above the LLQ. AUC0-t was calculated according to the mixed log-linear trapezoidal rule|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1|PK analysis set. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome at the specified time point for each arm, respectively.||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
661864|NCT01832506|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Sampling Time t (AUC0-t) After Single Dose of MSC2156119J|Area under the plasma concentration versus time curve from time zero to the last sampling time t at which the concentration is at or above the lower limit of quantification (LLQ) AUC0-t was calculated according to the mixed log-linear trapezoidal rule|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|PK analysis set included all subjects who had completed Cycle 1 without any relevant protocol violations with respect to factors that were likely to affect the PK results and who received at least first dose of study drug according to the protocol providing sufficient concentration time data to determine the PK endpoints for the study drug.||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
661865|NCT01832506|Secondary|Apparent Volume of Distribution Associated To The Terminal Phase (Vz/f) of MSC2156119J|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed and is calculated by Dose/(AUC(inf)*λz).|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1 and Day 14 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of the Vz/f.|||||
661866|NCT01832506|Secondary|Apparent Body Clearance (CL/f) of MSC2156119J|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. CL/F = Dose/AUC(inf), where AUC(inf) =AUC0-t + AUCextra. AUCextra represented an extrapolated value obtained by Clast/λz, where Clast was the calculated plasma concentration at the last sampling time point at which the measured plasma concentration was at or above the LLQ and λz is the terminal elimination rate constant.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1 and Day 14 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of CL/f.|||||
661867|NCT01832506|Secondary|Area Under the Concentration Time Curve From Time Zero to Extrapolated Infinite Time (AUC[Inf]) of MSC2156119J|AUC(inf) was calculated by combining AUC0-t and AUCextra. AUCextra represented an extrapolated value obtained by Clast/λz, where Clast was the calculated plasma concentration at the last sampling time point at which the measured plasma concentration was at or above the LLQ and λz is the terminal elimination rate constant.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1 and Day 14 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of AUCinf.|||||
661868|NCT01832506|Secondary|Apparent Terminal Half-life (t1/2) of MSC2156119J|Terminal half-life is the time measured for the plasma concentration to decrease by one half. Terminal half-life is calculated by dividing the natural logarithm to the base 2 (Ln2) divided by elimination rate constant (λz), where ‘λz’ is calculated by a linear regression of the log-linear concentration-time curve.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1 and Day 14 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of t1/2.|||||
661869|NCT01832506|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) After Multiple Dose of MSC2156119J||pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1|PK analysis set. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome at the specified time point for each arm, respectively.||hours||Full Range|Median
661870|NCT01832506|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) After Single Dose of MSC2156119J||pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|PK analysis set included all subjects who had completed Cycle 1 without any relevant protocol violations with respect to factors that were likely to affect the PK results and who received at least first dose of study drug according to the protocol providing sufficient concentration time data to determine the PK endpoints for the study drug.||hours||Full Range|Median
661871|NCT01832506|Secondary|Maximum Plasma Concentration (Cmax) After Multiple Dose of MSC2156119J||pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1|PK analysis set. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome at the specified time point for each arm, respectively.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
662161|NCT01828099|Secondary|Duration of Response (DOR)|DOR defined as the time from date of first documented CR or PR to date of first documented disease progression or death due to any cause|From randomization until death (up to approximately 34 months)||06/2018||||
661873|NCT01832506|Secondary|Number of Subjects With Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score of 2 or Higher|ECOG PS score is widely used by doctors and researchers to assess how a subjects’ disease is progressing, and is used to assess how the disease affects the daily living abilities of the subject, and determine appropriate treatment and prognosis. The score ranges from Grade 0 to Grade 4, where Grade 0 = Fully active, able to carry on all pre-disease performance without restriction, Grade 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (like light house work, office work), Grade 2 = Ambulatory and capable of all self-care but unable to carry out any work activities, Grade 3 = Capable of only limited self-care, confined to bed or chair more than 50% of waking hours and Grade 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.|Baseline up to 30 days after last dose of study drug administration (55.1 weeks)|Safety analysis set included all subjects who had received at least 1 dose of the IMP.||subjects|||Number
661874|NCT01832506|Secondary|Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs or TEAEs Leading To Death|An adverse event (AE) was defined as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the study drug. An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. TEAEs include both Serious TEAEs and non-serious TEAEs.|Baseline Up to 30 days after last dose of study drug administration (55.1 weeks)|Safety analysis set included all subjects who had received at least 1 dose of the IMP.||subjects|||Number
661875|NCT01832506|Primary|Number of Subjects Experiencing Dose Limiting Toxicity (DLT)|DLT: defined using National Cancer Institute Common Toxicity Criteria for Adverse Events Version 4.0, as any of following toxicities: Grade 4 neutropenia for more than 7 days; greater than or equal to (>=) Grade 3 febrile neutropenia; Grade 4 or Grade 3 thrombocytopenia with bleeding; >=Grade 3 nausea despite adequate treatment; >=Grade 3 any non-hematological AE (DLT defined specifically for following cases: >=Grade 3 liver adverse event [AE] requiring recovery period of more than 7 days or to Grade 1 without liver metastases or Grade 2 with liver metastases ; >=Grade 3 lipase and/or amylase elevation with confirmation of pancreatitis. An isolated lipase and/or amylase elevation of >=Grade 3 without clinical/radiological evidence of pancreatitis was not classified as DLT); and >=Grade 2 any AE not otherwise defined as DLT that, due to prolonged recovery to Grade 1 (or less) or baseline status, led to delay of treatment with IMP for more than 21 days.|Cycle 1 (Day 1 up to 21)|DLT analysis set included all subjects who completed Cycle 1 (having received 80% or more of planned cumulative dose of IMP for Cycle 1) or who stopped treatment with IMP during Cycle 1 because of DLT.||subjects|||Number
661876|NCT01832493|Primary|Optimal Electrode Configuration Determination Using Heart Sounds|Current practices use the measurement LV dP/dt max to determine how the optimal electrode configuration for a CRT device. Heart sounds, as measured by S1 Amplitude, is another method that could be used to determine the optimal electrode configuration. This outcome measure is the number of patients where the optimal electrode configuration setting as determined by heart sounds agrees with the optimal setting determined by LV dP/dt max|During implant|Patients with a RV tripolar S1 amplitude measurement and a LV dP/dT max measurement for all electrode configurations of interest.||participants|||Number
661877|NCT01832493|Primary|Optimal Electrode Configuration Determination Using Impedance|Current practices use the measurement LV dP/dt max to determine how the optimal electrode configuration for a CRT device. Intracardiac impedance is another method that could be used to determine the optimal electrode configuration. This outcome measure is the number of patients where the optimal electrode configuration setting as determined by intracardiac impedance agrees with the optimal setting determined by LV dP/dt max|During implant|Patients with a RV tripolar intracardiac impedance measurement and a LV dP/dT max measurement for all electrode configurations of interest.||participants|||Number
661878|NCT01832493|Primary|AV Interval Determination Using Heart Sounds|Current practices use the measurement LV dP/dt max to determine how the AV interval should be programmed in a CRT device. A heart sounds measure, called S1 Amplitude Transition, is another method that could be used to determine the optimal AV interval. This outcome measure is the number of patients where the optimal AV interval setting as determined by heart sounds agrees within one AV interval setting (30 milliseconds) of the optimal setting determined by LV dP/dt max|During implant|Patients with a RV tripolar S1 Amplitude Transition measurement and a LV dP/dT max measurement for all AV intervals of interest.||participants|||Number
661879|NCT01832493|Primary|AV Interval Determination Using Impedance|Current practices use the measurement LV dP/dt max to determine how the AV interval should be programmed in a CRT device. Intracardiac impedance is another method that could be used to determine the optimal AV interval. This outcome measure is the number of patients where the optimal AV interval setting as determined by intracardiac impedance agrees within one AV interval setting (30 milliseconds) of the optimal setting determined by LV dP/dt max.|During implant|Patients with a RV tripolar intracardiac impedance measurement and a LV dP/dT max measurement for all AV intervals of interest.||participants|||Number
661880|NCT01832155|Other Pre-specified|Feasibility Measure - Recruitment|The number of months it took to recruit 36 participants.|9 months|||months|||Number
661881|NCT01832155|Primary|Absolute Value of OA Pain at 8 Weeks|A single question that asked about the number of pain medications used per day for knee OA was also used to measure OA pain status.|8 weeks|||Number of pain medication/day||Standard Error|Mean
661882|NCT01832155|Other Pre-specified|Feasibility Measure - Safety|Safety was assessed by measuring the frequency of yoga related injuries that occur from group or home-based exercise sessions during the active treatment periods.|8 weeks|||injuries|||Number
661884|NCT01832155|Other Pre-specified|Feasibility Measures - Adherence|Feasibility was also measured by the home practice adherence rate during the 8 weeks program. Data from both intervention and wait-list control (during their treatment period) groups were collected. Home yoga practice adherence was determined by participants' report of the average number of minutes of yoga practiced at home.|8 Weeks|||minutes/week||Full Range|Mean
661887|NCT01832155|Secondary|Absolute Value of Quality of Life at 8 Weeks|"The self-perceived quality of life was assessed using the Short Form Health Survey (SF-12) which measures a total of 8 health domains: 4 physical and 4 mental component summary scales. Physical Health (physical functioning, role-physical, bodily pain, and general health)and Mental Health (vitality, social functioning, role-emotional, and mental health) Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. The Cantril Self-Anchoring Ladder that measures both current and in 5 years using steps from 0 to 10, where 0 represents the worst possible life and 10 represents the best possible life."|8 weeks|||units on a scale||Standard Error|Mean
661888|NCT01832155|Secondary|Absolute Value of Quality of Sleep at 8 Weeks|Pittsburgh Sleep Quality Index (PSQI) was used to measure quality of sleep. The PSQI is a 19-item self-rated questionnaire for evaluating subjective sleep quality over the previous month. The 19 questions are combined into 7 clinically-derived component scores, each weighted equally from 0–3 whereby 3 reflects the negative extreme on the Likert Scale. The 7 component scores are added to obtain a global score ranging from 0–21, with higher scores indicating worse sleep quality. A global score of ≥ 5 on the PSQI total scale, which is computed as a sum of the seven subscales (e.g., sleep quality, sleep latency, sleep duration, sleep disturbance, sleep efficiency, and use sleep medication) is associated with clinically significant sleep disruptions, including insomnia and major mood disorders.|8 weeks|||units on a scale||Standard Error|Mean
661889|NCT01832155|Secondary|Absolute Value of Physical Performance of the Lower Extremities (LE) at 8 Weeks|"Secondary outcome measures included physical performance of the LE which was assessed using the Short Physical Performance Battery (SPPB) developed by the National Institute on Aging. The test consists of three components: repeated chair stands (4 points), balance (4 points), and timed 8 walk (4 points). A maximum score of 12 points can be achieved. Higher values indicate better physical functions."|8 weeks|||units on a scale||Standard Error|Mean
661890|NCT01832155|Primary|Absolute Value of OA Symptoms at 8 Weeks|Primary outcome measures included: OA symptoms (pain, stiffness and function) were assessed using the Western Ontario and McMaster Universities OA Index scale (LK scale 3.1)(WOMAC). The WOMAC measures five items for pain (score range 0–20), two for stiffness (score range 0–8), and 17 for functional limitation (score range 0–68). A total WOMAC score is created by summing the items for all three subscales resulting in a possible score of 0 - 96. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.|8 weeks|||units on a scale||Standard Error|Mean
661891|NCT01831934|Other Pre-specified|Measurement of Intracellular Glutathione by Hi-D FACS (CD4 and CD8 T Cells) and Tandem Mass Spectrometry (Whole Blood)|This method relies on the ability of intracellular glutathione S-transferases to tag GSH to bimane to yield a bimane-GS conjugate that fluoresces at 440 nm.|Day 0-Day28||||||
661892|NCT01831934|Primary|Clinical Safety of TIV Vaccine|We will measure solicited local and systemic adverse events and SAEs for 1 month following immunization|Day 0 to Day28|||Participants|||Count of Participants
661893|NCT01831817|Secondary|Mean Change From Baseline in Dentine Hypersensitivity Experience Questionnaire (DHEQ) Total Score at Week 8|DHEQ Total score is an overall summary measure for the impact of dentine hypersensitivity on everyday life. Total score is calculated as the sum of 34 questions (each with a possible score of 1 to 7). The scale of responses range from 34 to 238. Higher values imply a worse outcome i.e. an increase in impact on dentine hypersensitivity on everyday life. Lower values imply a better outcome i.e. a decrease in impact on dentine hypersensitivity on everyday life.|Baseline and 8 weeks post administration of study treatment|The ITT population was defined as all participants who were randomized, administered at least one study treatment during the study and had at least one post baseline assessment of efficacy.||Score on a scale||Standard Deviation|Mean
661894|NCT01831817|Secondary|Mean Change From Baseline in Dentine Hypersensitivity Experience Questionnaire Total Score at Week 4|DHEQ Total score is an overall summary measure for the impact of dentine hypersensitivity on everyday life. Total score is calculated as the sum of 34 questions (each with a possible score of 1 to 7). The scale of responses range from 34 to 238. Higher values imply a worse outcome i.e. an increase in impact on dentine hypersensitivity on everyday life. Lower values imply a better outcome i.e. a decrease in impact on dentine hypersensitivity on everyday life.|Baseline and 4 weeks post administration of study treatment|The ITT population was defined as all participants who were randomized, administered at least one study treatment during the study and had at least one post baseline assessment of efficacy.||Score on a scale||Standard Deviation|Mean
661895|NCT01831817|Primary|Mean Change From Baseline in Visual Rating Scale Score at Week 8|"The intensity of response to stimulus will be rated using a 10 point scale where 1 denotes No Pain and 10 denotes Intense Pain."|Baseline and 8 weeks post administration of study treatment|The ITT population was defined as all participants who were randomized, administered at least one study treatment during the study and had at least one post baseline assessment of efficacy.||Score on a scale||Standard Deviation|Mean
661896|NCT01831817|Primary|Mean Change From Baseline in Visual Rating Scale Score at Week 4|"The intensity of response to stimulus will be rated using a 10 point scale where 1 denotes No Pain and 10 denotes Intense Pain."|Baseline and 4 weeks post administration of study treatment|The ITT population was defined as all participants who were randomized, administered at least one study treatment during the study and had at least one post baseline assessment of efficacy.||Score on a scale||Standard Deviation|Mean
661897|NCT01831817|Primary|Median Change From Baseline in Tactile Sensitivity at Week 8|Response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the subject whether the sensation caused discomfort. The pressure setting at which the subject gave two consecutive ‘yes’ responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g.|Baseline and 8 weeks post administration of study treatment|The ITT population was defined as all participants who were randomized, administered at least one study treatment during the study and had at least one post baseline assessment of efficacy.||grams||Full Range|Median
661972|NCT01830933|Primary|Percentage of Participants With Correct Perception of Risk|This outcome was measured through a survey. Women were asked what they thought about their risk of getting breast cancer was compared to other women of the same age.|baseline, one week post-initial visit (approximately one week)|||percentage of participants|||Number
661898|NCT01831817|Primary|Median Change From Baseline in Tactile Sensitivity at Week 4|Response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the subject whether the sensation caused discomfort. The pressure setting at which the subject gave two consecutive ‘yes’ responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g.|Baseline and 4 weeks post administration of study treatment|The ITT population was defined as all participants who were randomized, administered at least one study treatment during the study and had at least one post baseline assessment of efficacy.||grams||Full Range|Median
661899|NCT01831817|Primary|Mean Change From Baseline in Schiff Sensitivity Score at Week 8|Response to a constant jet of air applied to hypersensitive teeth was evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 – participant did not respond to air stimulation, 1 – participant responded to air stimulus but did not request discontinuation of stimulus, 2 – participant responded to air stimulus and requested discontinuation of stimulus, 3 – participant responded to air stimulus, considered stimulus to be painful and request discontinuation of stimulus.|Baseline and 8 weeks post administration of study treatment|The ITT population was defined as all participants who were randomized, administered at least one study treatment during the study and had at least one post baseline assessment of efficacy.||Score on a Scale||Standard Deviation|Mean
661900|NCT01831817|Primary|Mean Change From Baseline in Schiff Sensitivity Score at Week 4|Response to a constant jet of air applied to hypersensitive teeth was evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 – participant did not respond to air stimulation, 1 – participant responded to air stimulus but did not request discontinuation of stimulus, 2 – participant responded to air stimulus and requested discontinuation of stimulus, 3 – participant responded to air stimulus, considered stimulus to be painful and request discontinuation of stimulus.|Baseline and 4 weeks post administration of study treatment|The ITT population was defined as all participants who were randomized, administered at least one study treatment during the study and had at least one post baseline assessment of efficacy.||Score on a scale||Standard Deviation|Mean
661901|NCT01831791|Secondary|Serum Concentrations of Dihydrotestosterone (DHT) at Baseline, and After 26 Weeks and 52 Weeks|Blood samples for DHT analysis was collected at Baseline, Week 26 and Week 52. DHT values at a lower limit of quantification (LLQ) were imputed using 1/2 LLQ. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date). The LOCF method for missing data was used by carrying forward the last non-missing post-Baseline assessment for participants with missing visit data and/or for participants who discontinued from the study.|Baseline, Week 26 and Week 52|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population.||nanomole per liter (nmol/L)||Standard Deviation|Mean
661902|NCT01831791|Secondary|Change From Baseline in Quality of Life as Assessed by Dermatology Life Quality Index (DLQI) at Week 13, Week 26, Week 39, and Week 52|The DLQI is a 10-item validated measure developed specifically to assess quality of life (QoL) in participants with dermatological conditions. It assesses six domains: symptoms and feelings, daily activities, leisure, work ⁄school, personal relationships, and treatment. The DLQI total is the sum of 10 questions, each ranging from 0 (unanswered/not relevant,not at all) to 3 (very much). The higher the score, the greater the impairment of (QoL). Change from Baseline in DLQI scores is defined as the post-Baseline value minus the Baseline value. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date). The LOCF method for missing data was used by carrying forward the last non-missing post-Baseline assessment for participants with missing data and/or for participants who discontinued from the study.|Baseline, Week 13, Week 26, Week 39, and Week 52|ITT Population||Scores on a scale||Standard Deviation|Mean
661903|NCT01831791|Secondary|Change From Baseline in Sexual Problems as Assessed by the Problem Assessment Scale of the Sexual Function Inventory (PAS SFI) at Week 13, Week 26, Week 39, and Week 52|The Problem Assessment Scale of the Sexual Function Inventory (PAS SFI) questionnaire was used to assess participant-perceived problems in sexual function using 3 questions assessing problems with sex drive, erections and ejaculation. They are scored on a 5-point scale of 0 to 4 (0=big problem, 1= medium problem, 2=small problem, 3=very small problem, 4=no problem). Total scores range from 0-12. Change from Baseline in PAS SFI scores is defined as the post-Baseline value minus the Baseline value. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date). The LOCF method for missing data was used by carrying forward the last non-missing post-Baseline assessment for participants with missing data and/or for participants who discontinued from the study.|Baseline, Week 13, Week 26, Week 39 and Week 52|ITT Population||Scores on a scale||Standard Deviation|Mean
661904|NCT01831791|Secondary|Number of Participants With the Indicated Change From Baseline (BL) in the Stage of Androgenic Alopecia (AGA) According to the Norwood-Hamilton Scale at 26 Weeks and 52 Weeks|"The investigator/designee assessed the stage (Stage I to Stage VII) of AGA (i.e., male pattern baldness [MPB]) by utilizing the Norwood-Hamilton scale, used to measure the progression of MPB. Stage VII indicates worse balding than Stage I. Assessment was made by direct visual examination (aided by pictures) of the participant at Screening (Baseline), Week 26, and Week 52. v, vertex; most of the hair loss (commonly seen with advancing age) is on the vertex. a, type a variant; major features are (1) the entire anterior hairline border recedes in unison; (2) there is no simultaneous balding of the vertex. The number of participants with stage changes from Baseline are summarized. The LOCF method for missing data was used by carrying forward the last non-missing post-Baseline assessment for participants with missing data and/or for participants who discontinued from the study."|Baseline, Week 26 and Week 52|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population.||Participants|||Number
661905|NCT01831791|Secondary|Mean of Median Score for Panel Global Assessment of Improvement From Baseline to 26 Weeks and 52 Weeks for Vertex and Frontal Views|A central panel of 3 dermatologists independently assessed change in hair growth from Baseline to Week 26 and Week 52 using a 7-point scale: greatly decreased (-3), moderately decreased (-2), slightly decreased (-1), no change (0), slightly increased (1), moderately increased (2), and greatly increased (3). The median score, across the 3 panel members, is summarized. This assessment was performed by comparing the global photographs obtained at Baseline (Screening) with those subsequently obtained at Week 26 and Week 52. This assessment was made separately based on the global photography of the vertex and frontal views. The LOCF method for missing data was used for the assessment, if a participants was missing the Week 26 global photograph, but has a global photograph from an earlier assessment (i.e., a withdrawal visit), then that photograph was assessed during the panel review.|Baseline, Week 26 and Week 52|ITT Population. Only participants avilable at the specified time were analysed.||Scores on a scale||Standard Deviation|Mean
661906|NCT01831791|Secondary|Mean Change From Baseline (BL) in Terminal Hair Count Within a 2.54 cm Diameter Circle at Week 26 and Week 52|Terminal hair count was based on the terminal hair(>=60 μm in width) count within a target 2.54cm(1 inch) diameter circle at the vertex and was assessed by macrophotographic technique. A cosmetic ink dot was placed by means of a tattoo at BL on the scalp in the center of the circle as a marker to guide the placement of the hair count area at subsequent time points. If the ink dot faded between study visits, it was redone. For the macrophotography, hair was clipped before each photograph. Change from BL is defined as the post-BL value minus the BL value. BL value of an assessment is defined as the latest assessment on or before the BL date(latest non-missing value of either the treatment start date or the randomization date). The LOCF method for missing data was used by carrying forward the last non-missing post-BL assessment for participants with missing data and/or for participants who discontinued from the study.|Baseline, Week 26 and Week 52|ITT Population. Only participants avilable at the specified time were analysed.||Hair count||Standard Deviation|Mean
661907|NCT01831791|Secondary|Mean Change From Baseline (BL) in Target Area Hair Width Within a 2.54 cm Diameter Circle at Week 26 and Week 52|Target area hair width was based on the total width of the nonvellus hairs(>=30μm in width) within a target 2.54cm(1 inch) diameter circle at the vertex and was assessed by macrophotographic technique. A cosmetic ink dot was placed by means of a tattoo at BL on the scalp in the center of the circle as a marker to guide the placement of the hair count area at subsequent time points. If the ink dot faded between study visits, it was redone. For the macrophotography, hair was clipped before each photograph. Change from BL is defined as the post-BL value minus the BL value. The BL value of an assessment is defined as the latest assessment on or before the BL date(latest non-missing value of either the treatment start date or the randomization date). The LOCF method for missing data was used by carrying forward the last non-missing post-BL assessment value for participants with missing data and/or for participants who discontinued from the study.|Baseline, Week 26, and Week 52|ITT Population. Only participants avilable at the specified time were analysed.||microns x 10^-3||Standard Deviation|Mean
661908|NCT01831791|Secondary|Mean Change From Baseline (BL) in Target Area Hair Count Within a 2.54 Centimeter (cm) Diameter Circle at Week 26 and Week 52|Target area hair count is based on the nonvellus hair(>= 30 micrometer[μm] in width) count within a target 2.54cm(1 inch) diameter circle at the vertex and was assessed by macrophotographic technique. A cosmetic ink dot was placed by means of a tattoo at BL on the scalp in the center of the circle as a marker to guide the placement of the hair count area at subsequent time points. If the ink dot faded between study visits, it was redone. For the macrophotography, hair was clipped before each photograph. Change from BL is defined as post-BL value minus BL value. The BL value is defined as the latest assessment on or before the BL date(latest non-missing value of either treatment start date or randomization date). The last observation carried forward(LOCF) method for missing data was used by carrying forward the last non-missing post-BL assessment value for participants with missing data and/or for participants who discontinued from the study.|Baseline, Week 26, and Week 52|ITT Population. Only participants avilable at the specified time were analysed.||Hair count||Standard Deviation|Mean
661909|NCT01831791|Primary|Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)|The C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. The number of participants answering yes/no responses to questions about suicidal ideation (Question [Que] 1 and Que 2) at Baseline and post-Baseline (since last visit) and suicidal behaviors (Que 6 – Que 10) at post-Baseline (since last visit) are presented. Questions included the presence (yes) or absence (no) of the following: Que 1 - a wish to be dead; Que 2 - nonspecific (NS) active suicidal thoughts; Que 6 - preparatory acts or behavior; Que 7 - aborted attempt; Que 8 - interrupted attempt (int. att.); Que 9 - non-fatal actual suicide attempt; Que 10 - completed suicide and non-suicidal self-injurious behavior. Final assessment (FA) is the last post-Baseline measurement during the study.|Baseline, Week 26 and Week 52|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||Participants|||Number
661910|NCT01831791|Primary|Mean Change From Baseline in Heart Rate at the Indicated Time Points|Vital sign monitoring included heart rate measurement at the Screening visit, Baseline visit, Weeks 13, 26, 39, and 52 visits and the early withdrawal visit if applicable. Change from Baseline in heart rate is summarized for each post-Baseline assessment as well as for the final assessment (the last post-Baseline value in the study [final value]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date).|Baseline visit, Weeks 13, 26, 39, and 52 visits and or early withdrawal visit|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population.||Beats per minute||Standard Deviation|Mean
661957|NCT01831219|Other Pre-specified|Number of Operated Hips That Required Revision/Reoperation|Implant survivorship will be determined from the medical history CRF by comparing the percentage of ROBODOC and manual control subjects who have required revision or re-operation THA procedures on the hip in question since their original study procedure which took place 7-20 years previously.|At follow-up visit (7-20 years post-operatively)|||Hips|Hips||Number
661911|NCT01831791|Primary|Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points|Blood pressure measurements were taken to observe vital signs and included systolic blood pressure (SBP) and diastolic blood pressure (DBP) at the Screening visit, Baseline visit, Weeks 13, 26, 39, and 52 visits and the early withdrawal visit if applicable. Change from Baseline in SBP and DBP is summarized for each post-Baseline assessment as well as for the final assessment (the last post-Baseline value in the study [final value]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date).|Baseline, Weeks 13, 26, 39, and 52 visits and or early withdrawal visit|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population.||Millimeters of mercury (mmHg)||Standard Deviation|Mean
661912|NCT01831791|Primary|Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline|Blood samples for the assessment of the indicated laboratory parameters were taken at the Baseline, Week 26 and Week 52 visits and the early withdrawal visit where applicable. The laboratory parameters included ALP, ALT, AST, total bilirubin, total protein, sodium, potassium, albumin, glucose, creatinine, urea/BUN, hemoglobin, hematocrit, red blood cell (RBC) count, platelet count, white blood cell (WBC) count, and prostate-specific antigen (PSA). A laboratory value (LV) that is within the normal range is considered normal. A LV that is above the upper limit of the normal range is considered high abnormal. A LV that is below the lower limit of the normal range is considered low abnormal. Number of participants with any LV shifts from BL at any time post-BL are presented for, normal at BL to abnormal; normal at BL to high; normal at BL to low; normal or low at BL to high; normal or high at BL to low.|Baseline, Week 26 and 52 visits and/or early withdrawal visit|ITT Population. Only participants with a normal BL and at least one post-BL LV are analysed. ITT Population (represented by n=X in the category titles).||Participants|||Number
661913|NCT01831791|Primary|Mean Change From Baseline in Prostate-specific Antigen at the Indicated Time Points|Blood samples were collected for the measurement of prostate-specific antigen at Baseline, Week 26 and Week 52 visits and the early withdrawal visit where applicable. Change from Baseline in the prostate-specific antigen value is summarized for each post-Baseline assessment as well as for the final assessment (the last post-Baseline value in the study [final value]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date).|Baseline, Week 26 and 52 visits and/or early withdrawal visit|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||Microgram per liter (µg/L)||Standard Deviation|Mean
661914|NCT01831791|Primary|Mean Change From Baseline in Potassium, Sodium, Glucose and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points|Blood samples were collected for the measurement of potassium, sodium, glucose and urea/BUN at Baseline, Week 26 and Week 52 visits and the early withdrawal visit where applicable. Change from Baseline in the potassium, sodium, glucose and urea/BUN values are summarized for each post-Baseline assessment as well as for the final assessment (the last post-Baseline value in the study [final value]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date).|Baseline, Week 26 and 52 visits and/or early withdrawal visit|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||Millimoles per liter (mmol/L)||Standard Deviation|Mean
661915|NCT01831791|Primary|Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points|Blood samples were collected for the measurement of total bilirubin and creatinine at Baseline, Week 26 and Week 52 visits and the early withdrawal visit where applicable. Change from Baseline in the total bilirubin and creatinine values are summarized for each post-Baseline assessment as well as for the final assessment (the last post-Baseline value in the study [final value]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date).|Baseline, Week 26 and 52 visits and/or early withdrawal visit|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||Micromoles per liter (µmol/L)||Standard Deviation|Mean
661916|NCT01831791|Primary|Mean Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST) at the Indicated Time Points|Blood samples were collected for the measurement of ALT, ALP and AST at Baseline, Week 26 and Week 52 visits and the early withdrawal visit where applicable. Change from Baseline in the ALT, ALP and AST values are summarized for each post-Baseline assessment as well as for the final assessment (the last post-Baseline value in the study [final value]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date).|Baseline, Week 26 and 52 visits and/or early withdrawal visit|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||Units per liter (U/L)||Standard Deviation|Mean
661958|NCT01831219|Secondary|Visual Analog Pain Score|The Visual Analog Scale pain questionnaire will be used to measure clinical outcome. The pain VAS is a continuous scale which range from 0 (no pain) to 100 [100-mm scale] (“worst imaginable pain” ).|2 months|||units on a scale|Hips|Standard Deviation|Mean
661917|NCT01831791|Primary|Mean Change From Baseline in Red Blood Cells Count at the Indicated Time Points|Blood samples were collected for the measurement of the red blood cell count at Baseline, Week 26 and Week 52 visits and the early withdrawal visit where applicable. Change from Baseline in the red blood cell count value is summarized for each post-Baseline assessment as well as for the final assessment (the last post-Baseline value in the study [final value]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date).|Baseline, Week 26 and 52 visits and/or early withdrawal visit|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||10^12 cells per liter (TI/L)||Standard Deviation|Mean
661918|NCT01831791|Primary|Mean Change From Baseline in Platelet Count and White Blood Cell Count at the Indicated Time Points|Blood samples were collected for the measurement of platelet count and white blood cell count at Baseline, Week 26 and Week 52 visits and the early withdrawal visit where applicable. Change from Baseline in the platelet count and white blood cell count values are summarized for each post-Baseline assessment as well as for the final assessment (the last post-Baseline value in the study [final value]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date).|Baseline, Week 26 and 52 visits and/or early withdrawal visit|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||10^9 cells/Liter (GI/L)||Standard Deviation|Mean
661919|NCT01831791|Primary|Mean Change From Baseline in Hematocrit at the Indicated Time Points|Blood samples were collected for the measurement of hematocrit at Baseline, Week 26 and Week 52 visits and the early withdrawal visit where applicable. Change from Baseline in the hematocrit value is summarized for each post-Baseline assessment as well as for the final assessment (the last post-Baseline value in the study [final value]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date).|Baseline, Week 26 and 52 visits and/or early withdrawal visit|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||Proportion of red blood cells in blood||Standard Deviation|Mean
661920|NCT01831791|Primary|Mean Change From Baseline in Hemoglobin, Albumin and Total Protein at the Indicated Time Points|Blood samples were collected for the measurement of hemoglobin, albumin and total protein at Baseline, Week 26 and Week 52 visits and the early withdrawal visit where applicable. Change from Baseline in the hemoglobin, albumin and total protein values are summarized for each post-Baseline assessment as well as for the final assessment (the last post-Baseline value in the study [final value]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date).|Baseline, Week 26 and 52 visits and/or early withdrawal visit|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||Grams per liter (g/L)||Standard Deviation|Mean
661921|NCT01831791|Primary|Number of Participants With Change From Baseline in Breast Examination Results Any Time Post-Baseline Visit|A qualitative breast examination was performed at Baseline (Week 0), at the Week 26 Visit and at the Week 52 Visit (and at the early withdrawal visit, if applicable). Participants were assessed for presence (reported as yes) and absence (reported as no) of palpable breast tissue (PBT) or nipple tenderness (NT) and/or clinically significant (CS) PBT or NT at Baseline (BL), at each scheduled Post-BL assessment. Change from BL in breast examination results included the number of participants with change from ‘no (N)’ at BL to ‘yes (Y)’ at any Post-BL assessment for the presence of PBT or NT, and the number of participants with change from N at BL in CS to Y at any Post-BL assessment in CS for PBT and for NT. BL value of an assessment is defined as the latest assessment on or before the BL date (latest non-missing value of either the treatment start date or the randomization date).|Baseline to Week 52|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||Participants|||Number
661922|NCT01831791|Primary|Number of Participants With Drug-related, Treatment-emergent AEs and AE Leading to Premature Study Drug Discontinuation and Possible Suicidality-related Adverse Event (PSRAE)|An AE is considered drug-related if the relationship variable indicates so, or if the variable value is missing. Any AE with a start date on or after the treatment start date and on or before the last dose of treatment is considered on-treatment (treatment-emergent). This includes an AE with a missing onset date. Any AE which occurred, in the investigator’s judgement and is possibly related to suicidality, is defined as possible suicidality-related adverse event (PSRAE). Suicidality was assessed by using the columbia-suicide severity rating scale (C-SSRS) as determined by the investigator. The C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors.|From Baseline (Week 0) until Week 52|ITT Population||Participants|||Number
661955|NCT01831258|Secondary|Daytime Sleepiness (Subjective Sleep Quality)|Collected through the Epworth Sleepiness Scale (ESS) which is a subjective questionnaire and the participant answer 8 question with rating on the chance of dozing (from 0= no chance of dozing to 3 = high chance of dozing). The total is added with a range from 0-24. A total score of 0 means that the participant is not experiencing day time sleepiness, while total score of 24 means that the participant si extremely sleepy during the daytime.|4 weeks|Data for 65 participant were available||units on a scale||Standard Error|Mean
661923|NCT01831791|Primary|Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs)|An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign(including an abnormal laboratory finding), symptom, or disease(new or exacerbated) temporally associated with the use of a medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, a congenital anomaly/birth defect, important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, drug-induced liver injury, breast cancer in male participants, prostate cancer, spontaneous abortion in female partner of male participants|From Baseline (Week 0) until Week 52|Intent-to-Treat (ITT) Population: comprised of all participants who received a randomization number, regardless of whether or not treatment was administered||Participants|||Number
661924|NCT01831726|Secondary|Overall Survival (OS)|Overall survival (OS) is defined as the time from the date of first dose to the date of death due to any cause. If a patient is not known to have died, survival time will be censored at the date of the last contact|36 months|"Full Analysis Set (FAS) included all patients who received at least one dose of study drug.
FAS was used for the analysis of efficacy endpoints."||months||95% Confidence Interval|Median
661925|NCT01831726|Secondary|Progression-Free Survival (PFS)|Progression free survival (PFS) is defined as the time from the date of first dose to the date of first documented disease progression or relapse or death due to any cause.|36 months|"Full Analysis Set (FAS) included all patients who received at least one dose of study drug.
FAS was used for the analysis of efficacy endpoints."||months||95% Confidence Interval|Median
661926|NCT01831726|Secondary|Overall Response (OR) of Partial Response (PR) or Greater|Overall Response (OR) of Partial Response (PR) or greater based on local investigator assessment. For patients with solid tumors, the assessment criteria will be RECIST 1.1 and will include responses of CR and/or PR. For hematologic tumors other appropriate hematological response criteria will apply and are included in the appendices. ORR: CR+PR|Week 16|"Full Analysis Set (FAS) included all patients who received at least one dose of study drug.
FAS was used for the analysis of efficacy endpoints."||number of participants|||Number
661927|NCT01831726|Primary|Clinical Benefit Rate (CBR)|CBR determined by investigator assessment for each tumor assessment & defined as responses of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) ≥ 16 wks. Confirmed CR/PR or SD prior to 16 wks,but discontinued prior to 16 wks for reasons other than progressive disease,will have their clinical benefit defined non-evaluable; confirmed CR/PR or SD prior to 16 wks,but progressed prior to 16 wks,will be considered not achieving clinical benefit;if CR/PR/SD occurred prior to 16 wks,but progressed at or after 16 wks without evidence of CR/PR/SD at or after 16 wks,will also be considered not achieving clinical benefit. CBR will be analyzed by comparing achieved CBR with a historical control rate of each tumor type,& if there is at least 90% probability that the response rate in a tumor type exceeds the historical rate,then the tumor type will be considered a success. CBR: CR+PR+SD the assessment criteria was RECIST 1.1|Week 16|"Full Analysis Set (FAS) included all patients who received at least one dose of study drug.
FAS was used for the analysis of efficacy endpoints."||number of participants|||Number
661928|NCT01831466|Secondary|Percentage of Participants Achieving a PtGA Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 8 for Participants With a PtGA Score ≥2 at Baseline|The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5-point scale (0=clear; 1=almost clear; 2=mild; 3=moderate; 4=severe).|Baseline, Week 8|FASm. Only observed data were analyzed.||Percentage of Participants|||Number
661929|NCT01831466|Secondary|Percentage of Participants Achieving a Patient's Global Assessment (PtGA) Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 12 for Participants With a PtGA Score ≥2 at Baseline|The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5-point scale (0=clear; 1=almost clear; 2=mild; 3=moderate; 4=severe).|Baseline, Week 12|FASm. Only observed data were analyzed.||Percentage of Participants|||Number
661930|NCT01831466|Secondary|Change From Baseline to Week 8 in the DLQI Total Score|DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire assesses participant health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.|Baseline, Week 8|FASm. Only observed data were analyzed.||Score on a Scale||Standard Deviation|Mean
661931|NCT01831466|Secondary|Change From Baseline to Week 12 in the Dermatology Life Quality Index (DLQI) Total Score|DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire assesses participant health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.|Baseline, Week 12|FASm. Only observed data were analyzed.||Score on a Scale||Standard Deviation|Mean
661932|NCT01831466|Secondary|Change From Baseline to Week 8 in Clinic-Based ISI Scores|The severity of itch (pruritus) due to psoriasis was assessed using the ISI. Participants were asked to assess their “worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “no itching” (0) and “worst possible itching” (10) at the ends. Participants completed the ISI assessments at the clinic (i.e., clinic-based).|Baseline, Week 8|FASm. Only observed data were analyzed.||Score on a Scale||Standard Deviation|Mean
661933|NCT01831466|Secondary|Change From Baseline to Week 12 in Clinic-Based Itch Severity Item (ISI) Scores|The severity of itch (pruritus) due to psoriasis was assessed using the ISI. Participants were asked to assess their “worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “no itching” (0) and “worst possible itching” (10) at the ends. Participants completed the ISI assessments at the clinic (i.e., clinic-based).|Baseline, Week 12|FASm. Only observed data were analyzed.||Score on a Scale||Standard Deviation|Mean
661956|NCT01831258|Primary|Adherence to CPAP Treatment|Average used minutes (all days) taken from the CPAP device.|2 weeks|Adherence data could only be obtained for 61 participants||mins||Standard Error|Mean
661934|NCT01831466|Secondary|Percent Change From Baseline to Week 8 in BSA Affected With Psoriasis|Assessment of BSA with psoriasis was performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The percent surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant represents approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region can be used to determine the extent (%) to which a body regions is involved with psoriasis. BSA (%)=the sum of the BSAs of the 4 body regions. BSA assessment excluded head and neck, palms, finger nails, soles and toe nails.|Baseline, Week 8|FASm. Only observed data were analyzed.||Percent Change from Baseline||Standard Deviation|Mean
661935|NCT01831466|Secondary|Percent Change From Baseline to Week 12 in Body Surface Area (BSA) Affected With Psoriasis|Assessment of BSA with psoriasis was performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The percent surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant represents approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region can be used to determine the extent (%) to which a body regions is involved with psoriasis. BSA (%)=the sum of the BSAs of the 4 body regions. BSA assessment excluded head and neck, palms, finger nails, soles and toe nails.|Baseline, Week 12|FASm. Only observed data were analyzed.||Percent Change from Baseline||Standard Deviation|Mean
661936|NCT01831466|Secondary|Percentage of Participants Achieving PASI75, Relative to Baseline at Week 8|Combined assessment of lesion severity and area affected into single score. Body was divided into 4 regions: head, arms, trunk, legs. For each region, percent area of skin involved was estimated: 0=0% to 6=90-100%. Severity was estimated by clinical signs: erythema, induration, scaling; scale: 0=none to 4=maximum. Final PASI = sum of severity parameters for each region*area score*weight of region (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0=no disease to 72=maximal disease. The maximum PASI score was <72 since the PASI assessment excluded scalp, palms, finger nails, soles, and toe nails.|Baseline, Week 8|FASm. A participant with a missing value was considered a non-responder.||Percentage of Participants|||Number
661937|NCT01831466|Secondary|Percentage of Participants Achieving at Least a 75% Reduction in PASI Response (PASI75), Relative to Baseline at Week 12|Combined assessment of lesion severity and area affected into single score. Body was divided into 4 regions: head, arms, trunk, legs. For each region, percent area of skin involved was estimated: 0=0% to 6=90-100%. Severity was estimated by clinical signs: erythema, induration, scaling; scale: 0=none to 4=maximum. Final PASI = sum of severity parameters for each region*area score*weight of region (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0=no disease to 72=maximal disease. The maximum PASI score was <72 since the PASI assessment excluded scalp, palms, finger nails, soles, and toe nails.|Baseline, Week 12|FASm. A participant with a missing value was considered a non-responder.||Percentage of Participants|||Number
661938|NCT01831466|Secondary|Percent Change From Baseline to Week 8 in PASI|Combined assessment of lesion severity and area affected into single score. Body was divided into 4 regions: head, arms, trunk, legs. For each region, percent area of skin involved was estimated: 0=0% to 6=90-100%. Severity was estimated by clinical signs: erythema, induration, scaling; scale: 0=none to 4=maximum. Final PASI = sum of severity parameters for each region*area score*weight of region (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0=no disease to 72=maximal disease. The maximum PASI score was <72 since the PASI assessment excluded scalp, palms, finger nails, soles, and toe nails.|Baseline, Week 8|FASm. Only observed data were analyzed.||Percent Change from Baseline||Standard Deviation|Mean
661939|NCT01831466|Secondary|Percent Change From Baseline to Week 12 in Psoriasis Area and Severity Index (PASI)|Combined assessment of lesion severity and area affected into single score. Body was divided into 4 regions: head, arms, trunk, legs. For each region, percent (%) area of skin involved was estimated: 0=0% to 6=90–100%. Severity was estimated by clinical signs: erythema, induration, scaling; scale: 0=none to 4=maximum. Final PASI = sum of severity parameters for each region*area score*weight of region (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0=no disease to 72=maximal disease. The maximum PASI score was <72 since the PASI assessment excluded scalp, palms, finger nails, soles, and toe nails.|Baseline, Week 12|FASm. Only observed data were analyzed.||Percent Change from Baseline||Standard Deviation|Mean
661940|NCT01831466|Secondary|Percentage of Participants Achieving a PGA-G Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 8|Clinical signs of plaque psoriasis (E, I and S) were scored separately according to a 5-point severity scale (0 to 4) to provide PGA subscores, which described the overall severity of each clinical sign. After scoring each of the PGA subscores, a clinical evaluator of psoriasis performed an assessment of the overall severity of psoriasis and assigned a PGA-G score and category. 0=Clear, except for any residual discoloration (post-inflammatory hyperpigmentation and/or hypopigmentation) and 1=almost clear, the psoriasis is not entirely cleared and remaining plaques are light pink (not including post inflammatory hyperpigmentation), and/or have barely palpable elevation and/or have occasional fine scale. The PGA-G was a static assessment; i.e., without regard to a previous assessment.|Baseline, Week 8|FASm. A participant with a missing value was considered a non-responder.||Percentage of Participants|||Number
661941|NCT01831466|Secondary|Percentage of Participants Achieving a Gestalt Physician's Global Assessment (PGA-G) Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 12|Clinical signs of plaque psoriasis (E, I and S) were scored separately according to a 5-point severity scale (0 to 4) to provide PGA subscores, which described the overall severity of each clinical sign. After scoring each of the PGA subscores, a clinical evaluator of psoriasis performed an assessment of the overall severity of psoriasis and assigned a PGA-G score and category. 0=Clear, except for any residual discoloration (post-inflammatory hyperpigmentation and/or hypopigmentation) and 1=almost clear, the psoriasis is not entirely cleared and remaining plaques are light pink (not including post inflammatory hyperpigmentation), and/or have barely palpable elevation and/or have occasional fine scale. The PGA-G was a static assessment; i.e., without regard to a previous assessment.|Baseline, Week 12|FASm. A participant with a missing value was considered a non-responder.||Percentage of Participants|||Number
661959|NCT01831219|Secondary|UCLA Activity Score|The UCLA Activity Score will be used to measure clinical outcome. The UCLA Activity Score ranges 10 (best) to 0 (worst).|2 months|||units on a scale|Hips|Standard Deviation|Mean
662196|NCT01827462|Other Pre-specified|Evaluate Changes in Cytokine Profile in the Immune Response From Day 0 to Day 28-32 for Responses to the Vaccine Antigens||Day 0-Day28||||||
661942|NCT01831466|Secondary|Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) at Week 8|Clinical signs of plaque psoriasis (E, I, and S) were scored separately according to a 5-point severity scale (0 to 4) to provide PGA subscores, which described the overall severity of each clinical sign. The PGA-C was a static assessment; i.e., without regard to a previous assessment. The PGA subscores are then summed and averaged after which the total average was rounded to the nearest whole number to determine the PGA-C score and category. A higher score indicated a higher level of severity. 0 is equal to (=) cleared except for any residual discoloration and 1=almost clear, majority of lesions had individual scores for E+I+S that when summed, averaged, and rounded equaled 1.|Week 8|FASm. A participant with a missing value was considered a non-responder.||Percentage of Participants|||Number
661943|NCT01831466|Secondary|Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) at Week 12|Clinical signs of plaque psoriasis (E, I, and S) were scored separately according to a 5-point severity scale (0 to 4) to provide PGA subscores, which described the overall severity of each clinical sign. The PGA-C was a static assessment; i.e., without regard to a previous assessment. The PGA subscores are then summed and averaged after which the total average was rounded to the nearest whole number to determine the PGA-C score and category. A higher score indicated a higher level of severity. 0 is equal to (=) cleared except for any residual discoloration and 1=almost clear, majority of lesions had individual scores for E+I+S that when summed, averaged, and rounded equaled 1.|Week 12|FASm. A participant with a missing value was considered a non-responder.||Percentage of Participants|||Number
661944|NCT01831466|Primary|Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 8|Clinical signs of plaque psoriasis (E, I, and S) were scored separately according to a 5-point severity scale (0 to 4) to provide PGA subscores, which described the overall severity of each clinical sign. The PGA-C was a static assessment; i.e., without regard to a previous assessment. The PGA subscores are then summed and averaged after which the total average was rounded to the nearest whole number to determine the PGA-C score and category. A higher score indicated a higher level of severity. 0 is equal to (=) cleared except for any residual discoloration and 1=almost clear, majority of lesions had individual scores for E+I+S that when summed, averaged, and rounded equaled 1.|Baseline, Week 8|FASm. A participant with a missing value was considered a non-responder.||Percentage of Participants|||Number
661945|NCT01831466|Primary|Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to (≥) 2 Grade/Point Improvement From Baseline at Week 12|Clinical signs of plaque psoriasis (erythema [E], induration [I], and scaling [S]) were scored separately according to a 5-point severity scale (0 to 4) to provide PGA subscores, which described the overall severity of each clinical sign. The PGA-C was a static assessment; i.e., without regard to a previous assessment. The PGA subscores are then summed and averaged after which the total average was rounded to the nearest whole number to determine the PGA-C score and category. A higher score indicated a higher level of severity. 0 is equal to (=) cleared except for any residual discoloration and 1=almost clear, majority of lesions had individual scores for E+I+S that when summed, averaged, and rounded equaled 1.|Baseline, Week 12|The mild/moderate full analysis set (FASm) included all participants in the FAS with a baseline PGA-C disease severity of mild (2) or moderate (3). A participant with a missing value was considered a non-responder.||Percentage of Participants|||Number
661946|NCT01831258|Secondary|Subjective Treatment Efficacy - Patient Global Impression of Change (PGI) - Change|"Collected through the Patient Global Impression of Change (PGI).The questions ask Since beginning CPAP therapy, how would you describe the change (if any) in overall quality of life related to your OSA?. The questions has a scale of 1 = no change (or condition has got worse) to 7 = a great deal better and a considerable improvement that has made all the difference."|4 weeks|Data for 64 participant were available||units on a scale||Standard Error|Mean
661947|NCT01831258|Post-Hoc|Adherence in Patients With Signs of Moderate Clinical Insomnia|Adherence from the device (during their entire study period) in patients with moderate clinical insomnia (Insomnia Severity Index 15 or over)|8 weeks|Only participant with moderate clinical insomnia (Insomnia Severity Index of 15 and over) were included in the post-hoc.||minutes||Standard Error|Mean
661948|NCT01831258|Post-Hoc|Adherence in Patients With Signs of Moderate Clinical Insomnia|Adherence from the device (during their first treatment arm) in patients with moderate clinical insomnia (Insomnia Severity Index 15 or over)|4 weeks|Only participant with moderate clinical insomnia (Insomnia Severity Index of 15 and over) were included in the post-hoc.||minutes||Standard Error|Mean
661949|NCT01831258|Other Pre-specified|Apnea Hypopnea Index (AHI)|Collected through the device|2 weeks|Only 61 participant data was available.||events/hour||Standard Error|Mean
661950|NCT01831258|Other Pre-specified|Leak|The amount of Continuous Positive Airway Pressure (CPAP) leak was obtained through the device|One night|Obtained only 61 participant CPAP data.||L/min||Standard Error|Mean
661951|NCT01831258|Secondary|Subjective Treatment Efficacy - Patient Global Impression of Change (PGI) - Severity|"Collected through the Patient Global Impression of Change (PGI).The questions ask Since beginning CPAP therapy, how would you describe the chance (if any) in symptoms related to your OSA. The questions has a scale of 1 = no change (or condition has got worse) to 7 = a great deal better and a considerable improvement that has made all the difference."|4 weeks|Data for 64 participant were available||units on a scale||Standard Error|Mean
661952|NCT01831258|Secondary|OSA Impact of Daily Life (Fatigue)|Collected through the Fatigue Severity Scale (FSS). There are 9 question on fatigue with each question having a scale of 1 = strongly disagree and 7 = strongly agree. A lower total score (minimum of 9) = low severity with fatigue while a higher total score (maximum of 63) indicates a higher severity with fatigue.|4 weeks|Data for 64 participant were available||units on a scale||Standard Error|Mean
661953|NCT01831258|Secondary|OSA Impact of Daily Life|Collected through the Short Functional Outcomes of Sleep Questionnaire (FOSQ-10). The questionnaire has 10 questions which ask how daytime sleepiness has impacted their quality of life. Each question has a scale of 1 = yes extreme to 4 = No. Lower total score (min 10) means that the disease is affecting your quality of life while a higher total score (maximum 40) means that the disease is not affecting your quality of life.|4 weeks|Data for 62 participant were available||units on a scale||Standard Error|Mean
661960|NCT01831219|Secondary|Health Status Questionnaire-12|The Health Status Questionnaire-12 (HSQ-12) will be used to measure clinical outcome. HSQ-12 total score ranges from 0 (worst) to 800 (best).|2 months|||units on a scale|Hips|Standard Deviation|Mean
661961|NCT01831219|Secondary|Harris Hip Score|The Harris Hip Score will be measured to determine clinical outcome. The Harris Hip total score ranges 100 (best) to 0 (worst) and it is computed by the sum of the pain score (0–44 points), function (, 0–47 points), absence of deformity (4 points), and range of motion (5 points).|2 months|||units on a scale|Hips|Standard Deviation|Mean
661962|NCT01831219|Primary|Western Ontario and McMaster Universities Osteoarthritis Index|The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) will be used to measure clinical outcome. The WOMAC total score ranges 96 (best) to 0 (worst). The WOMAC pain score ranges 0–20, the stiffness score ranges 0–8, and functional limitation score ranges 0–68.|2 months|||units on a scale|Hips|Standard Deviation|Mean
661963|NCT01831219|Primary|Presence of Osteolysis|Presence of osteolysis determined by looking at patient x-rays as described by Gruen et al and Johnson et al.|14 months|||Hips|Hips||Number
661964|NCT01831154|Secondary|Intraoperative Glycemic Stability in Patients Undergoing Open Heart Surgery Compared Between Three Glycemic Protocols.|Intraoperative glycemic stability was operationalize as how often blood glucose levels were maintained as normal or maintained in the preset target ranges for each group. If intraoperative blood glucose levels fell outside of normal (hypoglycemia or hyperglycemia) or, outside the preset target ranges, for each protocol, for 3 consecutive blood glucoses (1.5 hours) despite insulin therapy a marker of inadequate glycemic control was recorded.|Measures of blood glucose every 30 minutes starting on entry into the operating room until exiting the operating room or 240 minutes whichever event occurred first|Inclusion > age 21, underwent elective or urgent CABG with or without combined valve surgery or valve surgery alone, on or off CPB. Exclusions were patients diagnosed with immunosuppression, end stage organ disease, or active infections. No data analysis could be performed because there were too few episodes of glycemic instability.||episodes out of target glucose range|||Number
661965|NCT01831154|Secondary|The Effect of Tight Glycemic Control on Intensive Care Unit Length of Stay in Patients Undergoing Open Heart Surgery|Length of stay (LOS) in the intensive care unit was measured by the total number of days each patient stayed in the intensive care unit.|ICU days measured every day the patient stayed in ICU starting with entry into the ICU from the Operating Room until discharge from the ICU to the ward|Inclusion > age 21, underwent elective or urgent CABG with or without combined valve surgery or valve surgery alone, on or off CPB. Exclusions were patients diagnosed with immunosuppression, end stage organ disease, or active infections.||days||Standard Deviation|Mean
661966|NCT01831154|Secondary|Intraoperative Blood Glucose Levels in Patients Undergoing Open Heart Surgery|Blood glucose values were obtained every 30 minutes in the intraoperative period, and were drawn and recorded by the certified registered nurse anesthetist (CRNA) performing the anesthetic. Repeated measured ANOVA with Greenhouse-Geisser correction was employed to determine if participants assigned to the tight glycemic group yielded lower blood glucose levels intraoperatively (every 30 minutes for 240 minutes) than the other two interventions. All blood glucose measures over the intraoperative period were averaged to produce a mean and standard deviation comparing the tight glycemic group to the other two interventional groups, Data points were blood glucose testing collected every 30 minutes starting on entry into the operating room.|Blood glucose measured every 30 minutes starting on entry into the operating room until exiting the operating room or 240 minutes, whichever event occurred first|Inclusion > age 21, underwent elective or urgent CABG with or without combined valve surgery or valve surgery alone, on or off CPB. Exclusions were patients diagnosed with immunosuppression, end stage organ disease, or active infections.||mg/dl||Standard Deviation|Mean
661967|NCT01831154|Primary|The Effect of Intraoperative Tight Glycemic Control on Postoperative C-Reactive Protein Plasma Levels in Patients Undergoing Open Heart Surgery|C-Reactive Protein concentrations were collected in addition to clinical signs for indications of infection. These biomarker concentrations were collected after successful separation from cardiopulmonary bypass (CPB), and every morning for five days postoperatively. Values were drawn by anesthesia providers and intensive care unit (ICU) registered nurses or laboratory personnel with the standard morning blood work. All C-Reactive Protein blood values from post cardiopulmonary bypass through postoperative day 5 were collected. The outcome measure was mean C-Reactive Protein values with standard deviation.|Post cardiopulmonary bypass and postoperative day 1 through 5|Inclusion > age 21, underwent elective or urgent CABG with or without combined valve surgery or valve surgery alone, on or off CPB. Exclusions were patients diagnosed with immunosuppression, end stage organ disease, or active infections. Six participants had > 50% missing data and were dropped from this analysis (4 tight, 1 in other two groups).||Mg/L||Standard Deviation|Mean
661968|NCT01831154|Primary|The Effect of Intraoperative Tight Glycemic Control on Postoperative Procalcitonin Plasma Levels in Patients Undergoing Open Heart Surgery|Procalcitonin concentrations were collected in addition to clinical signs for indications of infection. These biomarker concentrations were collected after successful separation from cardiopulmonary bypass (CPB), and every morning for five days postoperatively. Values were drawn by anesthesia providers and intensive care unit (ICU) registered nurses or laboratory personnel with the standard morning blood work. All procalcitonin blood values from post cardiopulmonary bypass through postoperative day 5 were collected. The outcome measure was mean procalcitonin values with standard deviation.|Post CPB and Postoperative days 1 through 5|Inclusion > age 21, underwent elective or urgent CABG with or without combined valve surgery or valve surgery alone, on or off CPB. Exclusions were patients diagnosed with immunosuppression, end stage organ disease, or active infections. Six participants had > 50% missing data and were dropped from this analysis (4 tight, 1 in other two groups).||ng/ml||Standard Deviation|Mean
661969|NCT01831154|Primary|Number of Participants Undergoing Open Heart Surgery With Postoperative Surgical Site Infection|The presence or absence of deep, or/and superficial sternal wound infection and deep, superficial harvest site infection within in six weeks postoperatively was a primary outcome variable. Infection assessment was performed during the intensive care phase, at hospital discharge, two-week post hospital discharge and six-week post hospital discharge by independent blinded researchers that were part of the cardiothoracic team.|six weeks postoperatively|Inclusion > age 21, underwent elective or urgent Coronary Artery Bypass Graft (CABG) with or without combined valve surgery or valve surgery alone, on or off cardiopulmonary bypass (CPB). Exclusions were patients diagnosed with immunosuppression, end stage organ disease, or active infections.||participants|||Number
661970|NCT01830933|Primary|Percentage of Participants Who Reported Discussion of Mammography Screening|Self reported discussion of mammography with physician.|up to 14 months|||percentage of participants|||Number
661973|NCT01830933|Primary|Knowledge of Breast Cancer Risk Factors|Risk knowledge was assessed using a post-survey. Participants could have scored 0-100 (with 0 meaning no correct answers, and 100 is all correct answers). This outcome was measured through a survey. Breast cancer risk knowledge was based on a series of eight questions in the survey. O|one week post-initial visit (approximately one week)|||units on a scale||Standard Deviation|Mean
661974|NCT01830920|Other Pre-specified|Composite of Death, Dialysis, or Sustained Impaired Renal Function|Sustained impaired renal function defined as a 35% increase in SCr from baseline at Day 30.|Day 30|Per Protocol Analysis set||Participants|||Count of Participants
661975|NCT01830920|Other Pre-specified|Composite of Death, Dialysis, or Sustained Impaired Renal Function|Sustained impaired renal function defined as a 35% increase in SCr from baseline at Day 30.|Day 30|Per Protocol Analysis set||Participants|||Count of Participants
661976|NCT01830920|Secondary|Duration of AKI|AKI is defined using the Scr-KDIGO criteria. Duration of AKI is defined as the number of days from start of AKI (SCr-KDIGO) where either SCr increase ≥ 0.3 mg/dL above pre-AKI reference point (if the value exists) or if SCr increase ≥1.5 times baseline or dialysis in the first 7 days up to discharge if prior to 7 days.|7 days OR up to discharge after surgery|Per Protocol Analysis set||days||Standard Deviation|Mean
661977|NCT01830920|Secondary|Severity of AKI|"AKI is defined using the KDIGO criteria, in which AKI is defined as any of the following:
Increase in SCr by ≥0.3 mg/dl (≥26.5 µmol/l) within 48 hours; or
Increase in SCr to ≥1.5 times baseline, which is known or presumed to have occurred within the prior 7 days; or
Urine volume <0.5 ml/kg/h for 6 hours.
Staging of AKI is defined as the following:
Stage 1: SCr 1.5 - 1.9 times baseline OR ≥0.3 mg/dL (≥26.5 µmol/L) increase, Urine output <0.5 ml/kg/hr for 6-12 hours Stage 2: SCr 2.0-2.9 times baseline, Urine output <0.5 ml/kg/h for ≥ 12 hours Stage 3: SCr 3.0 times baseline OR Increase in SCr to ≥5.0 mg/dL (≥353.6 µmol/L) OR Initiation of renal replacement therapy OR In patients <18 years, decrease in eGFR to <35 ml/min per 1.73 m^2, Urine output <0.3 ml/kg/h for ≥24 hours OR Anuria for ≥12 hours.
No AKI is considered the best outcome, and Stage 3 the worst outcome."|7 days|Per Protocol Analysis set||Participants|||Count of Participants
661978|NCT01830920|Secondary|Incidence of AKI|"AKI is defined using the SCr-KDIGO criteria, defined as the following:
Increase in SCr by ≥0.3 mg/dl (≥26.5 µmol/l) within 48 hours; or
Increase in SCr to ≥1.5 times baseline, which is known or presumed to have occurred within the prior 7 days."|7 days|Per Protocol Analysis set||Participants|||Count of Participants
661979|NCT01830920|Primary|Incidence of Acute Kidney Injury (AKI)|"Acute kidney injury (AKI) is defined using the KDIGO criteria, in which AKI is defined as any of the following:
Increase in SCr by ≥0.3 mg/dl (≥26.5 µmol/l) within 48 hours; or
Increase in SCr to ≥1.5 times baseline, which is known or presumed to have occurred within the prior 7 days; or
Urine volume <0.5 ml/kg/h for 6 hours."|7 days|Per Protocol Analysis set -||Participants|||Count of Participants
661980|NCT01830881|Secondary|Subject Sleepiness 30 Minutes Postprocedure|Subject sleepiness will be assessed 30 minutes postoperatively using a 100mm Visual Analog Scale with 0mm being None and 100mm being Worst Imaginable|30 minutes postoperatively|||units on a scale||Standard Deviation|Mean
661981|NCT01830881|Secondary|Subject Vital Signs (Oxygenation Saturation) 30 Minutes Postprocedure|Subject vital signs (oxygenation saturation) will be assessed 30 minutes postoperatively|30 minutes postoperatively|||percent saturation||Standard Deviation|Mean
661982|NCT01830881|Secondary|Subject Vital Signs (Oxygenation Saturation)|Subject oxygenation status will be assessed for the duration of the procedure|intraoperatively (30-60 minutes after premedication)|||percent saturation||Standard Deviation|Mean
661983|NCT01830881|Secondary|Subject's Correct Identification of Receiving Midazolam or Placebo|Number of patient's who could correctly determine if they received study drug or placebo when asked|30 minutes postoperatively|||Participants|||Count of Participants
661984|NCT01830881|Secondary|Subject Need for Additional Pain Medication|Subjects will be assessed for need of additional pain medications during the procedure and postoperatively|intraoperatively and postoperatively (0-120 minutes after premedication)||||||
661985|NCT01830881|Secondary|Subject Nausea 30 Minutes Postprocedure|Subject nausea will be assessed 30 minutes postoperatively using a 100mm Visual Analog Scale with 0mm being None and 100mm being Worst Imaginable|30 minutes postoperatively|||100-mm visual analog sclae for nausea||Full Range|Mean
661986|NCT01830881|Secondary|Subject Vital Signs (Heart Rate) 30 Minutes Postprocedure|Subject vital signs (heart rate) will be assessed 30 minutes postoperatively|30 minutes postoperatively|1 subject in the placebo group did not complete the study after changing mind to have abortion. Baseline information and characteristics on that subject was still collected and included where applicable in study outcomes and data.||bpm||Standard Deviation|Mean
661987|NCT01830881|Secondary|Subject Vital Signs (Heart Rate)|Subject heart rate will be assessed for the duration of the procedure|intraoperatively (30-60 minutes after premedication)|1 subject in the placebo group did not complete the study after changing mind to have abortion. Baseline information and characteristics on that subject was still collected and included where applicable in study outcomes and data.||bmp||Full Range|Mean
661988|NCT01830881|Secondary|Subject Extent of Sedation|Subject extent of sedation 30-60 minutes after premedication, just prior to procedure as measured by the 6-point Ramsay Scale (1 = patient anxious agitated, or restless; 2 = patient cooperative, oriented, and tranquil; 3 = patient asleep, responds to commands only; 4 = patient asleep, responds to gentle shaking, light glabellar tap, or loud auditory stimulus; 5 = patient asleep, responds to noxious stimuli such as firm nail bed pressure; 6 = patient asleep, has no response to firm nail bed pressure or other noxious stimuli)|3-60 minutes after premedication|1 subject in the placebo group did not complete the study after changing mind to have abortion. Baseline information and characteristics on that subject was still collected and included where applicable in study outcomes and data.||Participants|||Count of Participants
661989|NCT01830881|Secondary|Subject Extent of Amnesia|To assess the extent of amnesia 1-3 days postoperatively as measured by 100mm Visual Analog Scale with 0mm being Remember Nothing and 100mm being Remember Everything.|1-3 days postoperatively|||mm||Standard Deviation|Mean
661990|NCT01830881|Secondary|Subject Extent of Amnesia Using Amnesia Score|To assess the extent of amnesia 30 min postoperatively as measured by ability to recall procedure using 4-point scale (0 = unable to recall any proportion of the procedure, 1 = able to recall and describe some portions of the procedure, but overall has minimal recall of the procedure, 2 = able to recall and describe most of the procedure, but admits to inability to recall some portion of the procedure, 3 = able to recall and describe the entire procedure).|30 minutes postoperatively|||Participants|||Count of Participants
661991|NCT01830881|Secondary|Subject Satisfaction With Pain and Anxiety 1-3 Days Post Procedure|To assess whether oral midazolam is associated with differences in overall patient satisfaction with pain and anxiety control and abortion experience at 1-3 days postoperatively as measured by a mm VAS with 0mm being Not At All Satisfied and 100mm being Very Satisfied|1-3 days post-operatively|||mm on a 100 mm Visual Analog Scale||Standard Deviation|Mean
661992|NCT01830881|Secondary|Patient Satisfaction With Pain and Anxiety 30 Minutes Postoperatively|To assess whether oral midazolam is associated with differences in overall patient satisfaction with pain and anxiety control and abortion experience at 30 min postoperatively as measured by a mm Visual Analog Scale with 0mm being Not At All Satisfied and 100mm being Very Satisfied|30 minutes post-operatively|||mm on a 100 mm Visual Analog Scale||Standard Deviation|Mean
661993|NCT01830881|Secondary|Correlation Coefficient Between State-Trait Anxiety Inventory Form Y-1 and Visual Analog Scale for Anxiety at Baseline|To measure the Correlation coefficient between the State-Trait Anxiety Inventory (STAI) Form Y-1 and Visual Analog Scale for anxiety.|Baseline (upon entry into study)||||||
661994|NCT01830881|Secondary|Subject Perception of Pain During Cervical Dilation|Subjects will be asked to rate pain at the time of cervical dilation by marking along a mm Visual Analog Scale, with 0mm being No Pain and 100mm being Worst Imaginable Pain|with cervical dilation (30-60 minutes after premedication)|1 subject in the placebo group did not complete the study after changing mind to have abortion. Baseline information and characteristics on that subject was still collected and included where applicable in study outcomes and data.||mm||Standard Deviation|Mean
661995|NCT01830881|Secondary|Subject Perception of Anxiety With Patient Positioning Procedure|Subjects will be asked to rate anxiety prior to starting pelvic exam by marking along a mm Visual Analog Scale, with 0mm being No Anxiety and 100mm being Worst Imaginable Anxiety|prior to starting pelvic exam (30-60 minutes after premedication)|1 subject in the placebo group did not complete the study after changing mind to have abortion. Baseline information and characteristics on that subject was still collected and included where applicable in study outcomes and data.||mm||Standard Deviation|Mean
661996|NCT01830881|Secondary|Subject Perception of Pain and Anxiety Post Procedure|Subjects will be asked to rate anxiety and pain 30 minutes post-operatively by marking along a mm Visual Analog Scale, with 0mm being No Pain/Anxiety and 100mm being Worst Imaginable Pain/Anxiety|30 minutes post operatively|1 subject in the placebo group did not complete the study after changing mind to have abortion. Baseline information and characteristics on that subject was still collected and included where applicable in study outcomes and data.||mm||Standard Deviation|Mean
661997|NCT01830881|Secondary|Subject Perception of Pain and Anxiety Upon Entering Procedure Room|Subjects will be asked to rate anxiety and pain upon entering procedure room by marking along a mm Visual Analog Scale, with 0mm being No Pain/Anxiety and 100mm being Worst Imaginable Pain/Anxiety|upon entering procedure room (30-60 minutes after premedication)|1 subject in the placebo group did not complete the study after changing mind to have abortion. Baseline information and characteristics on that subject was still collected and included where applicable in study outcomes and data.||mm||Standard Deviation|Mean
661998|NCT01830881|Secondary|Subject Anticipated Perception of Pain and Anxiety During Uterine Aspiration at Baseline|Subjects will be asked to rate their anticipated anxiety and pain at the time of uterine aspiration by marking along a mm Visual Analog Scale, with 0mm being No Pain/Anxiety and 100mm being Worst Imaginable Pain/Anxiety|Baseline (upon entry into study)|||mm||Standard Deviation|Mean
661999|NCT01830881|Primary|Subject Perception of Pain and Anxiety During Uterine Aspiration|Subjects will be asked to rate anxiety and pain at the time of uterine aspiration by marking along a 100 mm Visual Analog Scale, with 0mm being No Pain/Anxiety and 100mm being Worst Imaginable Pain/Anxiety|at time of uterine aspiration (30-60 minutes after premedication)|1 subject in the placebo group did not complete the study after changing mind to have abortion. Baseline information and characteristics on that subject was still collected and included where applicable in study outcomes and data.||mm||Standard Deviation|Mean
662000|NCT01830855|Secondary|Percentage of Participants Achieving at Least a 2-Fold Increase in hSBA Titer for 4 Primary Test Strains and for 2 Primary Test Starins Before First Vaccination to 1 Month After the Third Bivalent rLP2086 Vaccination||One month after third bivalent rLP2086 vaccination (Vac)|Evaluable immunogenicity population. Here, N signifies participants with valid and determinate hSBA titers for the given strain at the specified time point.||percentage of participants||95% Confidence Interval|Number
662001|NCT01830855|Secondary|Percentage of Participants Achieving at Least a 3-Fold Increase in hSBA Titer for 4 Primary Test Strains and for Primary Test Starins Before First Vaccination to 1 Month After Third Bivalent rLP2086 Vaccination||One month after third bivalent rLP2086 vaccination|Data was not reported because 3-fold rise analyses was not performed as per change in planned analysis.|||||
662002|NCT01830855|Secondary|Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination|Results for PMB80[A22] 1:16, PMB2001[A56] 1:8, PMB2948[B24] 1:8 and PMB2707[B44] 1:8 are reported under secondary outcome measure ‘Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination.|Before Vaccination (Vac) 1, 1 Month after Vac 2, 3|Evaluable immunogenicity population. Here, N signifies participants with valid and determinate hSBA titers for the given strain at the specified time point.||percentage of participants||95% Confidence Interval|Number
662003|NCT01830855|Secondary|Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination||Before Vaccination (Vac) 1, 1 Month after Vac 2, 3|Evaluable immunogenicity population. Here N signifies participants with valid and determinate hSBA titers for the given strain at the specified time point.||percentage of participants||95% Confidence Interval|Number
662004|NCT01830855|Secondary|hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains and for 2 Primary Test Strains and Before First Vaccination and 1 Month After the Second Bivalent rLP2086 Vaccination||Before vaccination (Vac) 1, 1 Month after Vac 2|Evaluable immunogenicity population. Here, N signifies participants with valid and determinate hSBA titers for the given strain at the specified time point.||titer||95% Confidence Interval|Geometric Mean
662127|NCT01828593|Other Pre-specified|Change From Baseline in Peripheral CD4+ T Cell Counts in 3rd Baseline CD4+ Quartile (Greater Than 630 and Less Than or Equal to 890)|3rd Baseline CD4+ Quartile (Greater than 630 and Less than or Equal to 893)|Baseline and 4 weeks|||cells/microliter||Standard Deviation|Mean
662005|NCT01830855|Secondary|Percentage of Participants Achieving at Least a 4-Fold Increase in hSBA Titer for 2 Primary Strains Before First Vaccination to 1 Month After the Second and Third Bivalent rLP2086 Vaccination||One month after second, third vaccination|Evaluable immunogenicity population. Here, N signifies participants with valid and determinate hSBA titers for the given strain at both the specified time point.||percentage of participants||95% Confidence Interval|Number
662006|NCT01830855|Secondary|Percentage of Participants Achieving at Least a 4-Fold Increase in hSBA Titer for Each of the 4 Primary Strains Before First Vaccination to 1 Month After the Second Bivalent rLP2086 Vaccination for Group 1|Groups 2 and 3 were included for the Lot consistency analysis for primary strains only (hSBA geometric mean titer). The immunogenicity of two MnB strains in lots 1, 2, 3 were required to test for lot consistency. These data are presented separately in the other endpoints. The data for all the strains in Lot 1 (Group 1) is sufficient to describe the immunogenicity expected with the vaccine. The analytical plan was included in the protocol and agreement was reach with EMA and FDA.|One month after second Bivalent rLP2086 vaccination|Evaluable immunogenicity population. Here, N signifies participants with valid and determinate hSBA titers for the given strain at both the specified time point.||percentage of participants||95% Confidence Interval|Number
662007|NCT01830855|Secondary|Percentage of Participants Achieving Composite hSBA Titer >=Lower Limit of Quantitation for All 4 Primary Strains Before First Vaccination and 1 Month After Second Bivalent rLP2086 Vaccination for Group 1|Groups 2 and 3 were included for the Lot consistency analysis for primary strains only (hSBA geometric mean titer). The immunogenicity of two MnB strains in lots 1, 2 ,3 were required to test for lot consistency. These data are presented separately in the other endpoints. The data for all the strains in Lot 1 (Group 1) is sufficient to describe the immunogenicity expected with the vaccine. The analytical plan was included in the protocol and agreement was reach with EMA and FDA.|Before vaccination 1, 1 Month after Vaccination 2|Evaluable immunogenicity population. Here, N signifies participants valid and determinate hSBA results on all 4 strains at the given time point.||percentage of participants||95% Confidence Interval|Number
662008|NCT01830855|Secondary|hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1|Groups 2 and 3 were included for the Lot consistency analysis for primary strains only (hSBA geometric mean titer). The immunogenicity of two MnB strains in lots 1, 2, 3 were required to test for lot consistency. These data are presented separately in the other endpoints. The data for all the strains in Lot 1 (Group 1) is sufficient to describe the immunogenicity expected with the vaccine. The analytical plan was included in the protocol and agreement was reach with EMA and FDA.|Before first vaccination, 1 month after third vaccination|Evaluable immunogenicity population. Here, number of participants analyzed signifies participants with valid and determinate hSBA titers for the given strain. Here, N signifies participants with valid and determinate assay results for the given antigen or strain.||titer||95% Confidence Interval|Geometric Mean
662009|NCT01830855|Secondary|Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1|Groups 2 and 3 were included for the Lot consistency analysis for primary strains only (hSBA geometric mean titer). The immunogenicity of two MnB strains in lots 1, 2, 3 were required to test for lot consistency. These data are presented separately in the other endpoints. The data for all the strains in Lot 1 (Group 1) is sufficient to describe the immunogenicity expected with the vaccine. The analytical plan was included in the protocol and agreement was reach with EMA and FDA.|Before first vaccination, 1 month after third vaccination (Vac)|Evaluable immunogenicity population. Here, number of participants analyzed signifies participants with valid and determinate hSBA titers for the given strain. Here, N signifies participants with valid and determinate hSBA titers for the given strain at the specified time point.||percentage of participants||95% Confidence Interval|Number
662010|NCT01830855|Secondary|Percentage of Participants With hSBA Titers >=LLOQ for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination for Group 1|Groups 2 and 3 were included for the Lot consistency analysis for primary strains only (hSBA geometric mean titer). The immunogenicity of two MnB strains in lots 1, 2, 3 were required to test for lot consistency. These data are presented separately in the other endpoints. The data for all the strains in Lot 1 (Group 1) is sufficient to describe the immunogenicity expected with the vaccine. The analytical plan was included in the protocol and agreement was reach with EMA and FDA.|Before first vaccination, 1 month after third vaccination|Evaluable immunogenicity population. Here, number of participants analyzed signifies participants with valid and determinate hSBA titers for the given strain. Here, N signifies participants with valid and determinate hSBA titers for the given strain at the specified time point.||percentage of participants||95% Confidence Interval|Number
662011|NCT01830855|Primary|Number of Days Participant's Missed School or Work Due to AE During the Vaccination Phase||From the first vaccination up to 1 month after the third vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure.||days||Standard Deviation|Mean
662012|NCT01830855|Primary|Percentage of Participants Reporting at Least 1 Immediate AE After Third Vaccination||Within 30 minutes after third vaccination|Safety population for third vaccination included all participants who received the third dose of investigational product (rLP2086 or HAV) and for whom safety information was available from third vaccination until post third-vaccination blood draw.||percentage of participants||95% Confidence Interval|Number
662013|NCT01830855|Primary|Percentage of Participants Reporting at Least 1 Immediate AE After Second Vaccination||Within 30 minutes after second vaccination|Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline) and for whom safety information was available from second vaccination until prior to third vaccination.||percentage of participants||95% Confidence Interval|Number
662014|NCT01830855|Primary|Percentage of Participants Reporting at Least 1 Immediate AE After First Vaccination||Within 30 minutes after first vaccination|Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or HAV) and for whom safety information was available from first vaccination until prior to second vaccination.||percentage of participants||95% Confidence Interval|Number
662015|NCT01830855|Primary|Percentage of Participants With at Least 1 Adverse Event During the Vaccination Phase||From the first vaccination up to 1 month after the third vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.||percentage of participants||95% Confidence Interval|Number
662016|NCT01830855|Primary|Percentage of Participants With at Least 1 Adverse Event Within 30 Days After Any Vaccination||Within 30 Days after any vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.||percentage of participants||95% Confidence Interval|Number
662017|NCT01830855|Primary|Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Third Vaccination||Within 30 days after third vaccination|Safety population for third vaccination included all participants who received the third dose of investigational product (rLP2086 or HAV) and for whom safety information was available from third vaccination until post third-vaccination blood draw.||percentage of participants||95% Confidence Interval|Number
662018|NCT01830855|Primary|Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Second Vaccination||Within 30 days after second vaccination|Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline) and for whom safety information was available from second vaccination until prior to third vaccination.||percentage of participants||95% Confidence Interval|Number
662019|NCT01830855|Primary|Percentage of Participants With at Least 1 Adverse Event (AE) WIthin 30 Days After First Vaccination||Within 30 days after first vaccination|Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or HAV) and for whom safety information was available from first vaccination until prior to second vaccination.||percentage of participants||95% Confidence Interval|Number
662020|NCT01830855|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Throughout the Study Period||From the first vaccination up to 6 month after the third vaccination|Safety population included all participants who received at least 1 dose of the investigational product and had safety information available.||percentage of participants||95% Confidence Interval|Number
662021|NCT01830855|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Follow-Up Phase||From 1 month after third vaccination up to 6 months after the third vaccination|Safety population: all participants who had at least 1 dose of investigational product (rLP2086 or HAV/saline) for whom safety information was available from after post third-vaccination blood draw to 6 months after last study vaccination.||percentage of participants||95% Confidence Interval|Number
662022|NCT01830855|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Vaccination Phase||From the first vaccination up to 1 month after the third vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.||percentage of participants||95% Confidence Interval|Number
662023|NCT01830855|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Any Vaccination||Within 30 Days After any Vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.||percentage of participants||95% Confidence Interval|Number
662024|NCT01830855|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Third Vaccination||Within 30 days after third vaccination|Safety population for third vaccination included all participants who received the third dose of investigational product (rLP2086 or HAV) and for whom safety information was available from third vaccination until post third-vaccination blood draw.||percentage of participants||95% Confidence Interval|Number
662025|NCT01830855|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Second Vaccination||30 days after second vaccination|Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline) and for whom safety information was available from second vaccination until prior to third vaccination.||percentage of participants||95% Confidence Interval|Number
662026|NCT01830855|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After First Vaccination||Within 30 days after first vaccination|Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or HAV) and for whom safety information was available from first vaccination until prior to second vaccination.||percentage of participants||95% Confidence Interval|Number
662027|NCT01830855|Primary|Percentage of Participants With at Least 1 Medically Attended AE Throughout the Study Period||From the first vaccination up to 6 month after the third vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.||percentage of participants||95% Confidence Interval|Number
662028|NCT01830855|Primary|Percentage of Participants With at Least 1 Medically Attended AE During the Follow-Up Phase||From 1 month after third vaccination up to 6 months after the third vaccination|Safety population: all participants who had at least 1 dose of investigational product (rLP2086 or HAV/saline) for whom safety information was available from after post-vaccination 3 blood draw to 6 months after last study vaccination.||percentage of participants||95% Confidence Interval|Number
662029|NCT01830855|Primary|Percentage of Participants With at Least 1 Medically Attended AE During the Vaccination Phase||From the first vaccination up to 1 month after the third vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.||percentage of participants||95% Confidence Interval|Number
662030|NCT01830855|Primary|Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Any Vaccination||Within 30 days after any vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.||percentage of participants||95% Confidence Interval|Number
662128|NCT01828593|Other Pre-specified|Change From Baseline in Peripheral CD4+ T Cell Counts in 2nd Baseline CD4+ Quartile (Greater Than 418 and Less Than or Equal to 630|2nd Baseline CD4+ Quartile (greater than 418 and less than or equal to 630)|Baseline and 4 weeks|||cells/microliter||Standard Deviation|Mean
662031|NCT01830855|Primary|Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Third Vaccination||Within 30 days after third vaccination|Safety population for third vaccination included all participants who received the third dose of investigational product (rLP2086 or HAV) and for whom safety information was available from third vaccination until post third-vaccination blood draw.||percentage of participants||95% Confidence Interval|Number
662032|NCT01830855|Primary|Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Second Vaccination||Within 30 days after second vaccination|Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline) and for whom safety information was available from second vaccination until prior to third vaccination.||percentage of participants||95% Confidence Interval|Number
662033|NCT01830855|Primary|Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After First Vaccination||Within 30 days after first vaccination|Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or HAV) and for whom safety information was available from first vaccination until prior to second vaccination.||percentage of participants||95% Confidence Interval|Number
662034|NCT01830855|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Throughout the Study Period||From the first vaccination up to 6 month after the third vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.||percentage of participants||95% Confidence Interval|Number
662035|NCT01830855|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Follow-Up Phase||From 1 month after third vaccination up to 6 months after the third vaccination|Safety population: all participants who had at least 1 dose investigational product (rLP2086 or HAV/saline) for whom safety information was available from after post third-vaccination blood draw to 6 months after last study vaccination.||percentage of participants||95% Confidence Interval|Number
662036|NCT01830855|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Vaccination Phase||From the first vaccination up to 1 month after the third vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.||percentage of participants||95% Confidence Interval|Number
662037|NCT01830855|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Any Vaccination||Within 30 days after any vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.||percentage of participants||95% Confidence Interval|Number
662038|NCT01830855|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Third Vaccination||Within 30 days after third vaccination|Safety population for third vaccination included all participants who received the third dose of investigational product (rLP2086 or HAV) and for whom safety information was available from third vaccination until post third-vaccination blood draw.||percentage of participants||95% Confidence Interval|Number
662039|NCT01830855|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Second Vaccination||Within 30 days after second vaccination|Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline) and for whom safety information was available from second vaccination until prior to third vaccination.||percentage of participants||95% Confidence Interval|Number
662040|NCT01830855|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After First Vaccination||Within 30 days after first vaccination|Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or HAV) and for whom safety information was available from first vaccination until prior to second vaccination.||percentage of participants||95% Confidence Interval|Number
662041|NCT01830855|Primary|Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination|Here, N signifies participants with known values reporting specific characteristic.|Within 7 Days after third vaccination|Safety population for third vaccination included all participants who received third dose of investigational product (rLP2086 or HAV) and for whom safety information was available from third vaccination until post third-vaccination blood draw. Here, number of participants analyzed signifies participants with known values after third vaccination.||percentage of participants||95% Confidence Interval|Number
662042|NCT01830855|Primary|Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination|Here, N signifies participants with known values reporting specific characteristic.|Within 7 Days after second vaccination|Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline), for whom safety information was available from second vaccination until prior to third vaccination.Here,number of participants analyzed signifies participants with known values after second vaccination.||percentage of participants||95% Confidence Interval|Number
662043|NCT01830855|Primary|Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination|Here, N signifies participants with known values reporting specific characteristic.|Within 7 Days after first vaccination|Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or HAV) and for whom safety information was available from first vaccination until prior to second vaccination.Here,number of participants analyzed signifies participants with known values after the first vaccination.||percentage of participants||95% Confidence Interval|Number
662044|NCT01830855|Primary|Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Third Vaccination||Within 7 Days after third vaccination|Safety population for third vaccination included all participants who received third dose of investigational product (rLP2086 or HAV) and for whom safety information was available from third vaccination until post third-vaccination blood draw.Here,number of participants analyzed signifies participants with known values after third vaccination.||percentage of participants||95% Confidence Interval|Number
662129|NCT01828593|Other Pre-specified|Change From Baseline in Peripheral CD4+ T Cell Counts in Lowest Baseline CD4+ Quartile (Less Than or Equal to 418)|Lowest baseline CD4+ quartile (less than or equal to 418)|Baseline and 4 weeks|||cells/microliter||Standard Deviation|Mean
662045|NCT01830855|Primary|Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Second Vaccination||Within 7 Days after second vaccination|Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline), for whom safety information was available from second vaccination until prior to third vaccination.Here,number of participants analyzed signifies participants with known values after second vaccination.||percentage of participants||95% Confidence Interval|Number
662046|NCT01830855|Primary|Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After First Vaccination||Within 7 Days after first vaccination|Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or HAV) and for whom safety information was available from first vaccination until prior to second vaccination. Here,number of participants analyzed signifies participants with known values after the first vaccination.||percentage of participants||95% Confidence Interval|Number
662047|NCT01830855|Primary|hSBA Geometric Mean Titers (GMTs) for Each of the 2 Primary Test Strains Measured 1 Month After the Third Vaccination With Bivalent rLP2086 Vaccine||One month after third bivalent rLP2086 vaccination|Evaluable immunogenicity population. Here, N signifies participants with valid and determinate hSBA titers for the given strain.||titer||95% Confidence Interval|Geometric Mean
662048|NCT01830855|Primary|Percentage of Participants With >=4 Fold Rise in Serum Bactericidal Assay Using Human Complement (hSBA) for 4 Primary Strains and Composite Response (hSBA >=Lower Limit of Quantification [LLOQ] for All 4 Primary Strains Combined) for Group 1|Groups 2 and 3 were included for the Lot consistency analysis for primary strains only (hSBA geometric mean titer). The immunogenicity of two MnB strains in lots 1,2,3 were required to test for lot consistency. These data are presented separately in the other endpoints. The data for all the strains in Lot 1 (Group 1) is sufficient to describe the immunogenicity expected with the vaccine. The analytical plan was included in the protocol and agreement was reach with EMA and FDA. Here, N signifies participants with valid and determinate hSBA titers for given strain at specified time point.|One month after third bivalent rLP2086 vaccination|Evaluable immunogenicity population: all eligible participants randomized, who received correct investigational product, had pre/post vaccination blood drawn at pre-specified time points, had valid and determinate assay results for proposed analysis, received no prohibited treatment or prohibited vaccines, and had no major protocol violations.||percentage of participants||95% Confidence Interval|Number
662049|NCT01830790|Secondary|Change in Central Foveal Thickness as Assessed by Optical Coherence Tomography (OCT)||Baseline, 1hour, and 3 hours post-treatment|Study was terminated early due to inadequate support to complete recruitment/data analysis. No outcome measure data was collected.|||||
662050|NCT01830790|Primary|Change in Choroidal Thickness as Assessed on Enhanced-Depth Imaging Optical Coherence Tomography (EDI-OCT)||Baseline, 1 hour, and 3 hours post-treatment|Study was terminated early due to inadequate support to complete recruitment/data analysis. No outcome measure data was collected.|||||
662051|NCT01830699|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Any adverse event reported by the study participant during the four time points studied in the trial in either arm will be recorded.|4 weeks|||participants|||Number
662052|NCT01830699|Secondary|Improvement in Pain|Secondary outcomes are improvement in pain (as assessed by patient self report, range between 0 and 10, with 0 as no pain and 10 described as the worst pain in their life).|4 weeks|||units on a scale||Standard Deviation|Mean
662053|NCT01830699|Primary|Improvement in Shoulder Function|The QuickDASH will be used as the primary outcome to assess improvement in pain and function of patients with clinical symptoms and signs of subacromial bursitis randomized to either rilonacept vs. corticosteroid injection. The QuickDASH is an 11 question form, a short version of the Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH). It ranges from 0 (no symptoms/full function) to 100 (maximal symptoms/no function). No units are specified. Cutoff scores: < 15 = no problem, 16 - 40 = problem, but working, > 40 = unable to work. US population mean +/- SD is 10.1 +/- 14.7.|4 weeks|||units on a scale||Standard Deviation|Mean
662054|NCT01830543|Secondary|Percentage of Participants With Stent Thrombosis|The percentage of participants with the first occurrence of stent thrombosis were evaluated.|Up to Month 12 and end of DAPT-Month 1, 6 and 12|The safety analysis set is defined as all randomized participants who received at least 1 dose of study drug. Here 'N' signifies number of participants who were evaluable for this outcome measure, 'n' signifies number of participants analyzed at specific time-point in this outcome measure.||percentage of participants|||Number
662055|NCT01830543|Secondary|Percentage of Participants With Stroke|The percentage of participants with the first occurrence of Stroke were evaluated.|Up to Month 12 and end of DAPT-Month 1, 6 and 12|The safety analysis set is defined as all randomized participants who received at least 1 dose of study drug. Here 'N' signifies number of participants who were evaluable for this outcome measure, 'n' signifies number of participants analyzed at specific time-point in this outcome measure.||percentage of participants|||Number
662056|NCT01830543|Secondary|Percentage of Participants With Myocardial Infarction|The percentage of participants with the first occurrence of Myocardial Infarction were evaluated.|Up to Month 12 and end of DAPT-Month 1, 6 and 12|The safety analysis set is defined as all randomized participants who received at least 1 dose of study drug. Here 'N' signifies number of participants who were evaluable for this outcome measure, 'n' signifies number of participants analyzed at specific time-point in this outcome measure.||percentage of participants|||Number
662057|NCT01830543|Secondary|Percentage of Participants With Cardiovascular Death|The percentage of participants with the first occurrence of cardiovascular death were evaluated.|Up to Month 12 and end of DAPT-Month 1, 6 and 12|The safety analysis set is defined as all randomized participants who received at least 1 dose of study drug. Here 'N' signifies number of participants who were evaluable for this outcome measure, 'n' signifies number of participants analyzed at specific time-point in this outcome measure.||percentage of participants|||Number
662058|NCT01830543|Secondary|Percentage of Participants With Composite of Adverse Cardiovascular Events (Cardiovascular Death, Myocardial Infarction (MI) and Stroke)|Percentage of participants who experienced adverse cardiovascular events (cardiovascular death, myocardial Infarction (MI) and stroke) collectively, were assessed.|Up to Month 12 and end of DAPT-Month 1, 6 and 12|The safety analysis set is defined as all randomized participants who received at least 1 dose of study drug. Here 'N' signifies number of participants who were evaluable for this outcome measure, 'n' signifies number of participants analyzed at specific time-point in this outcome measure.||percentage of participants|||Number
662059|NCT01830543|Secondary|Percentage of Participants With Bleeding Requiring Medical Attention (BRMA)|A BRMA event is defined as any bleeding event that requires medical treatment, surgical treatment, or laboratory evaluation, and does not meet criteria for a major or minor bleeding event.|Up to Month 12 and end of DAPT-Month 1, 6 and 12|The safety analysis set is defined as all randomized participants who received at least 1 dose of study drug. Here 'n' signifies number of participants analyzed at specific time-point in this outcome measure.||percentage of participants|||Number
662060|NCT01830543|Secondary|Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Minor Bleeding|TIMI minor bleeding event is defined as any clinically overt sign of hemorrhage (including imaging) that is associated with a fall in hemoglobin concentration of 3 to <5 g/dL (or, when hemoglobin concentration is not available, a fall in hematocrit of 9 percent to <15 percent).|Up to Month 12 and end of DAPT-Month 1, 6 and 12|The safety analysis set is defined as all randomized participants who received at least 1 dose of study drug. Here 'n' signifies number of participants analyzed at specific time-point in this outcome measure.||percentage of participants|||Number
662061|NCT01830543|Secondary|Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding|TIMI major bleeding is defined as any symptomatic intracranial hemorrhage, Clinically overt signs of hemorrhage (including imaging) associated with a drop in hemoglobin of >= 5 g/dL (or when the hemoglobin concentration is not available, an absolute drop in hematocrit of >=15 percent).|Up to Month 12 and end of DAPT-Month 1, 6 and 12|The safety analysis set is defined as all randomized participants who received at least 1 dose of study drug. Here, 'n' signifies number of participants analyzed at specific time-point in this outcome measure.||percentage of participants|||Number
662062|NCT01830543|Primary|Percentage of Participants With Clinically Significant Bleeding|Clinically significant bleeding is a composite of Thrombolysis in Myocardial Infarction (TIMI) major bleeding, minor bleeding, and bleeding requiring medical attention (BRMA). TIMI major bleeding is defined as any symptomatic intracranial hemorrhage, clinically overt signs of hemorrhage (including imaging) associated with a drop in hemoglobin of greater than or equal to (>=) 5 grams per deciliter (g/dL) (or when the hemoglobin concentration is not available, an absolute drop in hematocrit of >=15 percent (%)). TIMI minor bleeding event is defined as any clinically overt sign of hemorrhage (including imaging) that is associated with a fall in hemoglobin concentration of 3 to less than (<) 5 g/dL (or, when hemoglobin concentration is not available, a fall in hematocrit of 9 percent to <15 percent). A BRMA event is defined as any bleeding event that requires medical treatment, surgical treatment, or laboratory evaluation, and does not meet criteria for a major or minor bleeding event.|Up to Month 12|The safety analysis set is defined as all randomized participants who received at least 1 dose of study drug.||percentage of participants|||Number
662063|NCT01830205|Secondary|Number of Participants With Out-of-range Vital Signs Reported as Adverse Events|The total number of participants with abnormal range vital signs which were considered as adverse events was determined.|Baseline up to Day 5 post dose|Analysis was done in safety data set population.||Participants|||Number
662064|NCT01830205|Secondary|Number of Participants With Clinically Relevant Changes in Electrocardiogram (ECG) Reported as Adverse Events|The number of participants with clinically relevant changes in ECG which were considered as adverse events was determined.|Baseline up to Day 5 post dose|Analysis was done in safety data set population.||Participants|||Number
662065|NCT01830205|Secondary|Number of Participants With Clinically Significant Laboratory Marked Abnormalities Reported as Adverse Events|Significant laboratory abnormalities were defined as any test results which were observed beyond the clinically acceptable limits as per the discretion of investigator.|Baseline up to Day 5 post dose|The analysis was done in safety population.||Participants|||Number
662066|NCT01830205|Secondary|Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events and Who Died|Adverse event (AE) was defined as any new unfavorable symptom, sign, or disease or worsening of a pre-existing condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalisation.|First dose up to Day 5 post last dose for AEs; up to 30 days post last dose for SAEs|Analysis was done in safety data set population, defined as all the participants who received the study medication.||Participants|||Number
662067|NCT01830205|Secondary|Apparent Volume of Distribution (Vd/F) of Daclatasvir|The Vd/F was calculated by dividing the product of the dose and mean residence time by area under the plasma concentration-time curve from time zero extrapolated to infinite time.|Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose|Pharmacokinetic (PK) data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The PK analysis was based on C-G CLcr grouping method: normal renal function (n=11), ESRD (n=10), moderate (n=5) and severe renal impairment (n=6). Mild participants (n=4) are also counted as per their original allocation.||Liters||Geometric Coefficient of Variation|Geometric Mean
662068|NCT01830205|Secondary|Renal Clearance (CLR) of Daclatasvir|The CLR was calculated by dividing the total amount excreted in the urine from 0 to 96 hours by the area under the plasma concentration-time curve from time zero extrapolated to infinite time.|Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose|Pharmacokinetic (PK) data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The PK analysis was based on C-G CLcr grouping method: normal renal function (n=11), ESRD (n=3), moderate (n=5) and severe renal impairment (n=5). Mild participants (n=4) are also counted as per their original allocation.||mL/min||Geometric Coefficient of Variation|Geometric Mean
662069|NCT01830205|Secondary|Percent Urinary Recovery (%UR) of Daclatasvir|The percentage of daclatasvir recovered in the urine was determined by using validated liquid chromatography-tandem mass spectrometry methods. The sum of the percentage of dose recovered in urine from all intervals was calculated to obtain the total percentage of urinary excretion.|Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose|Pharmacokinetic (PK) data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The PK analysis was based on C-G CLcr grouping method: normal renal function (n=11), ESRD (n=3), moderate (n=5) and severe renal impairment (n=5). Mild participants (n=4) are also counted as per their original allocation.||Percentage of daclatasvir recovered||Geometric Coefficient of Variation|Geometric Mean
662197|NCT01827462|Other Pre-specified|Evaluate Changes in Cytokine Profile in the Immune Response From Day 0 to Day 5-7 for T Cells and Antibody-secreting Cells (ASCs)||Day 0 to 7||||||
662070|NCT01830205|Secondary|Unbound Apparent Clearance (CLU/F) of Daclatasvir|The CLU/F was calculated by dividing the apparent total body clearance by mean fraction of unbound drug from 1 hour post dose time point.|Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose|Pharmacokinetic (PK) data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The PK analysis was based on C-G CLcr grouping method: normal renal function (n=11), ESRD (n=10), moderate (n=5) and severe renal impairment (n=6). Mild participants (n=4) are also counted as per their original allocation.||mL/min||Geometric Coefficient of Variation|Geometric Mean
662071|NCT01830205|Secondary|Apparent Total Body Clearance (CLT/F) of Daclatasvir|Apparent total body clearance was calculated by dividing the dose by area under the plasma concentration-time curve from time zero extrapolated to infinite time.|Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose|Pharmacokinetic (PK) data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The PK analysis was based on C-G CLcr grouping method: normal renal function (n=11), ESRD (n=10), moderate (n=5) and severe renal impairment (n=6). Mild participants (n=4) are also counted as per their original allocation.||milliliter/minute (mL/min)||Geometric Coefficient of Variation|Geometric Mean
662072|NCT01830205|Secondary|Plasma Half-life (T-half) of Daclatasvir|Terminal half-life was the time required for one half of the total amount of administered drug eliminated from the body.|Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose|Pharmacokinetic (PK) data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The PK analysis was based on C-G CLcr grouping method: normal renal function (n=11), ESRD (n=10), moderate (n=5) and severe renal impairment (n=6). Mild participants (n=4) are also counted as per their original allocation.||hours||Geometric Coefficient of Variation|Geometric Mean
662073|NCT01830205|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Daclatasvir|Tmax was defined as the time required to reach maximum observed plasma concentration. Tmax was directly determined from the raw plasma concentration-time data.|Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose|Pharmacokinetic (PK) data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The PK analysis was based on C-G CLcr grouping method: normal renal function (n=11), ESRD (n=10), moderate (n=5) and severe renal impairment (n=6). Mild participants (n=4) are also counted as per their original allocation.||hours||Full Range|Median
662074|NCT01830205|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Last Measurable Concentration [AUC(0-T)] of Daclatasvir|AUC(0-T) was calculated as the sum of linear trapezoids using non-compartmental analysis.|Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose|Pharmacokinetic (PK) data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The analysis was based on C-G CLcr grouping method: normal renal function (n=11), ESRD (n=10), moderate (n=5) and severe renal impairment (n=6). Mild participants (n=4) are also counted as per their original allocation.||ng*hour (h)/mL||Geometric Coefficient of Variation|Geometric Mean
662075|NCT01830205|Secondary|Unbound Maximum Observed Plasma Concentrations of Daclatasvir|Unbound Maximum observed plasma concentrations (Cmaxu) was calculated by multiplying maximum observed plasma concentrations by mean fraction of unbound drug from 1 hour post-dose time point.|Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose|Pharmacokinetic (PK) data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The PK analysis was based on C-G CLcr grouping method: normal renal function (n=11), ESRD (n=10), moderate (n=5) and severe renal impairment (n=6). Mild participants (n=4) are also counted as per their original allocation.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
662076|NCT01830205|Secondary|Maximum Observed Plasma Concentration (Cmax) of Daclatasvir|Maximum observed plasma concentration following drug administration from the raw plasma concentration-time data. The plasma samples were analyzed for daclatasvir by using a validated liquid chromatography tandem mass spectrometric (LC-MS/MS) assay.|Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose|Pharmacokinetic (PK) data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The PK analysis was based on C-G CLcr grouping method: normal renal function (n=11), ESRD (n=10), moderate (n=5) and severe renal impairment (n=6). Mild participants (n=4) are also counted as per their original allocation.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
662077|NCT01830205|Secondary|Unbound Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity Time (AUC(INF)u) of Daclatasvir|AUC(INF)u was calculated by multiplying the area under the plasma concentration-time curve from time zero extrapolated to infinite time by mean fraction of unbound drug from 1 hour post-dose time point.|Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose|Pharmacokinetic (PK) data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The PK analysis was based on C-G CLcr grouping method: normal renal function (n=11), ESRD (n=10), moderate (n=5) and severe renal impairment (n=6). Mild participants (n=4) are also counted as per their original allocation.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
662078|NCT01830205|Primary|Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of Daclatasvir|AUC(INF) was estimated by summing the area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration and the extrapolated area, computed by the quotient of the last observable concentration and elimination rate constant. The pharmacokinetic (PK) analysis was based on Cockcroft-Gault (C-G) creatinine clearance (CLcr) grouping method: normal renal function, end stage renal disease (ESRD), moderate and severe renal impairment. Mild participants were counted as per their original allocation.|Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose|PK data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The PK analysis was based on the C-G CLcr grouping method: normal renal function (n=11), ESRD (n=10), moderate (n=5) and severe renal impairment (n=6). Mild participants (n=4) are also counted as per their original allocation.||nanograms*hours/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
662079|NCT01830140|Primary|Percentage of Patients With an Increase in Macroscopic Conjunctival Hyperemia in Either Eye|Macroscopic conjunctival hyperemia (eye redness) is graded in each eye on a 5-point scale (Scale 0 to +3: none, trace, mild, moderate, severe). An increase (worsening) in macroscopic conjunctival hyperemia is defined as an increase in macroscopic conjunctival hyperemia grade of at least 1 from baseline in either eye.|Baseline, 6 Weeks|Intent-to-Treat: all randomized patients||Percentage of Patients|||Number
662080|NCT01830127|Secondary|SVR4: Plasma HCV RNA Level Less Than 25 IU/mL at 4 Weeks After End of Treatment (EOT)|Sustained virologic response (SVR) at Week 4 post-treatment (SVR4): Plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level <25 IU/mL at 4 weeks after EOT. SVR4 was analyzed in a descriptive manner using percentage.|4 weeks after End of Treatment|(Treated Set) All patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment, regardless of randomization.||Percentage of participants||95% Confidence Interval|Number
662081|NCT01830127|Primary|SVR12: Plasma HCV RNA Level Less Than 25 IU/mL at 12 Weeks After End of Treatment (EOT)|Sustained virologic response (SVR) at Week 12 post-treatment (SVR12): Plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level <25 IU/mL(international units per millilitre) at 12 weeks after EOT. SVR12 was analyzed in a descriptive manner using percentage.|12 weeks after End of Treatment|(Treated Set) All patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment, regardless of randomization.||Percentage of participants||95% Confidence Interval|Number
662082|NCT01829919|Primary|Ct (ng/mL) Multiple Dose Pharmacokinetics of Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|"C(t) is the measured plasma level Concentration of the drug at time = t expressed as nanograms per milliliter."|Day 19|Safety and evaluable pharmacokinetic populations = 24 randomized subjects.||ng/mL||Standard Deviation|Mean
662083|NCT01829919|Primary|Cavg,ss (ng/mL) Multiple Dose Pharmacokinetics of Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg||Day 19|Safety and evaluable pharmacokinetic populations = 24 randomized subjects.||ng/mL||Standard Deviation|Mean
662084|NCT01829919|Primary|Fluctuation Index (%) Multiple Dose Pharmacokinetics of Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|Fluctuation Index is (Cmax-Cmin)/Cavg,ss. It is peak trough fluctuation within one dosing interval at steady state.|Day 19|Safety and evaluable pharmacokinetic populations = 24 randomized subjects.||Percentage of steady state concentration||Full Range|Mean
662085|NCT01829919|Primary|Accumulation Index Multiple Dose Pharmacokinetics of Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg at Day 19|Accumulation Index is the ratio of AUC 0-24 after multiple doses versus a single dose. It is the increase in drug plasma concentration after multiple dosing until a steady state is reached. In this case the steady state Accumulation Index was calculated at Day 19. Accumulation Index is calculated at the end of the dosing period.|Day 19|Safety and evaluable pharmacokinetic populations = 24 randomized subjects.||Ratio||Full Range|Mean
662086|NCT01829919|Primary|Tmax (Hour) Multiple Dose Pharmacokinetics of Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg||Day 19|Safety and evaluable pharmacokinetic populations = 24 randomized subjects.||Hours||Full Range|Mean
662087|NCT01829919|Primary|Cmin (ng/mL) Multiple Dose Pharmacokinetics of Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg||Day 19|Safety and evaluable pharmacokinetic populations = 24 randomized subjects.||ng/mL||Standard Deviation|Mean
662088|NCT01829919|Primary|Cmax (ng/mL) Multiple Dose Pharmacokinetics of Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg||Day 19|Safety and evaluable pharmacokinetic populations = 24 randomized subjects.||ng/mL||Standard Deviation|Mean
662089|NCT01829919|Primary|AUC (Hour*ng/mL) Multiple Dose Pharmacokinetics of Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg||Day 19|Safety and evaluable pharmacokinetic populations = 24 randomized subjects.||Hour*ng/mL||Standard Deviation|Mean
662090|NCT01829919|Primary|Median t1/2 Single Dose Pharmacokinetics of Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg||Day 1|Safety and evaluable pharmacokinetic populations = 24 randomized subjects.||hours||Full Range|Median
662091|NCT01829919|Primary|Mean t1/2 Single Dose Pharmacokinetics of Brisdelle™ (Paroxetine Mesylate) Capsules 7.5 mg||Day 1|Safety and evaluable pharmacokinetic populations = 24 randomized subjects.||Hours||Standard Deviation|Mean
662092|NCT01829919|Primary|Kel (Hour^-1) Single Dose Pharmacokinetics of Brisdelle™ (Paroxetine Mesylate) Capsules 7.5 mg||Day 1|Safety and evaluable pharmacokinetic populations = 24 randomized subjects.||Hour^(-1)||Standard Deviation|Mean
662093|NCT01829919|Primary|Cmax (ng/mL) Single Dose Pharmacokinetics of Brisdelle™ (Paroxetine Mesylate) Capsules 7.5 mg||Day 1|Safety and evaluable pharmacokinetic populations = 24 randomized subjects.||ng/mL||Standard Deviation|Mean
662094|NCT01829919|Primary|AUC (Hour*ng/mL) Single Dose Pharmacokinetics of Brisdelle™ (Paroxetine Mesylate) Capsules 7.5 mg||Day 1|Safety and evaluable pharmacokinetic populations = 24 randomized subjects.||Hour*ng/mL||Standard Deviation|Mean
662095|NCT01829516|Secondary|Average Percentage of Correct Responses on a Social Perception Task, Reading the Mind in the Eyes Test (RMET) After Administration of Oxytocin vs. Placebo During the 3-week Study.|We will examine the effects of intranasal oxytocin administration on overall RMET performance in moderate to heavy social alcohol drinkers after placebo or oxytocin administration. The RMET has 28 items. Each item is an cropped photo of a person's eyes with four emotion labels around it. The subjects are asked to select which one of the four emotion words best describes the emotion that the eyes are showing. RMET is scored by adding up the total number of correct responses (range 0-28). The mean percent correct is then calculated.|Administered at visits 2 and 3|1 subject did not complete the RMET task, so only 31 participant responses were analyzed for this task.||Mean percent correct responses||Standard Error|Mean
662096|NCT01829516|Primary|Change in Craving on the Alcohol Urge Questionnaire (AUQ) After Administration of Oxytocin vs. Placebo During the 3-week Study.|Change in craving represented by the mean difference in Alcohol Urge Questionnaire (AUQ) craving scores between alcohol and water cues (e.g., a positive alcohol-water score indicates cue-induced craving) after administration of oxytocin vs. placebo during the 3-week study. Craving for alcohol was assessed prior to the water and alcohol cues and again after each stimulus presentation using the 8-item Alcohol Urge Questionnaire (AUQ) (Bohn et al., 1995), in which subjects indicate how much they agree or disagree with statements regarding their alcohol craving on a 7-point Likert scale. AUQ craving scores are calculated by averaging responses to the 8 items. Each item is scored on a 1 to 7 scale (Strongly Disagree = 1 and Strongly Agree = 7). Items 2 and 7 are reverse scored. A total score is computed by averaging the item scores and ranges from 1 to 7. Higher scores reflect greater craving.|Measured just prior to and after each of the water and alcohol cues at visits 2 and 3.|In this crossover study a total of 32 participants were analyzed for each intervention.||units on a 7-pt Likert Scale||Standard Error|Mean
662130|NCT01828593|Primary|Frequency of Daily Unformed Bowel Movements|Change in number of abnormal or unformed stools by week 4|Baseline and 4 weeks|||abnormal or unformed stools||Standard Deviation|Mean
662131|NCT01828476|Secondary|Overall Survival||5 years|Study was terminated early and insufficient data was collected to assess this outcome measure.|||||
662097|NCT01829503|Secondary|Quality of Life|Patient reported symptoms and quality of life, as well as objective indicators of sleep, will be examined with quantitative summaries, followed by analyses with GLM approaches, whether or not the participant completed all cycles of therapy, or all assessments. Exploratory analyses will examine effects of the chemotherapy regimen on multiple symptoms. Explanatory variables will include covariate (e.g., age) and mediator variables (e.g., expectations) across cycles of chemotherapy.|Up to 5 years||10/2017||||
662098|NCT01829503|Secondary|Relapse-Free Survival in Participants With Complete Response, Complete Response With Incomplete Count Recovery or Partial Response, and Received Maintenance Therapy||Up to 38 months|Evaluable participants who experienced a Clinical Response (CR) of Complete Response, Complete Response with Incomplete Count Recovery, or Partial Response.||months||90% Confidence Interval|Median
662099|NCT01829503|Secondary|Relapse-Free Survival in Participants With Complete Response or Complete Response With Incomplete Count Recovery.||Up to 38 months|Evaluable participants who experienced a Clinical Response (CR) of Complete Response or Complete Response with Incomplete Count Recovery.||months||90% Confidence Interval|Median
662100|NCT01829503|Secondary|Demographic Characteristics and Clinical Measures as Potential Predictors of Overall Survival (OS)|Median number of months of survival per individual demographic characteristics and clinical measures.|Up to 38 months (median follow-up = 25.4 months)|All study participants.||months||95% Confidence Interval|Median
662101|NCT01829503|Secondary|Overall Survival (OS) in Participants Who Experienced Complete Response, Complete Response With Incomplete Count Recovery, or Partial Response||Up to 38 months (median follow-up = 25.4 months)|Evaluable participants who experienced a Clinical Response (CR) of Complete Response, Complete Response with Incomplete Count Recovery, or, Partial Response.||months||90% Confidence Interval|Median
662102|NCT01829503|Secondary|Overall Survival (OS) in Participants Who Experienced Complete Response or Complete Response With Incomplete Count Recovery||Up to 38 months (median follow-up = 25.4 months)|Evaluable participants who experienced a Clinical Response (CR) of Complete Response, or Complete Response with Incomplete Count Recovery.||months||90% Confidence Interval|Median
662103|NCT01829503|Secondary|Overall Survival (OS) in Participants Who Experienced Complete Response||Up to 38 months (median follow-up = 25.4 months)|Evaluable participants who experienced a Clinical Response (CR) of Complete Response.||months||90% Confidence Interval|Median
662104|NCT01829503|Secondary|Overall Survival (OS)||Up to 38 months (median follow-up = 25.4 months)|All study participants.||months||90% Confidence Interval|Median
662105|NCT01829503|Secondary|Proportion of Participants With Survival to Four and Eight Weeks and One Year|The proportion of all participants experiencing four and eight-week mortality, or, who were alive at one year.|Up to one year (4 weeks, 8 weeks, and one year)|All study participants.||Proportion of participants||90% Confidence Interval|Number
662106|NCT01829503|Secondary|Numbers of Patients (Out of 44) Experiencing Adverse Events With CTCAE Grade ≥ 3 or Adverse Events Grade ≥ 4|The number of participants (out of 44) experiencing adverse events, with CTCAE Grade ≥ 3 or Adverse Events Grade ≥ 4|Up to 38 months|All study participants.||Participants|||Number
662107|NCT01829503|Primary|Proportion of Participants With Clinical Response (CR)|The number of participants (out of 39) who experienced Clinical Response as Complete Response, or, Complete Response + Complete Response with Incomplete Count Recovery (exact Clopper-Pearson confidence interval).|Up to 38 months|Evaluable participants with known Clinical Response (CR) (Complete Response, Complete Response with Incomplete Count Recovery, or Partial Response), and participants who had Progressive Disease.||Proportion of participants||90% Confidence Interval|Number
662108|NCT01829503|Primary|Number of Participants by Best Clinical Response Experienced|The number of participants who experienced either a Complete Response, Complete Response with Incomplete Count Recovery, Partial Response, or Progressive Disease. Complete response: Less than 5% blasts in an aspirate sample of a patient who has an absolute neutrophil count of >1000µ/L and platelets >100,000µ/L; Complete response with incomplete count recovery: Complete response except for residual neutropenia (<1000µ/L) or thrombocytopenia (<100,000µ/L) Partial response: Decrease of at least 50% in the percentage of blasts to 5-25% in the bone marrow aspirate; Progressive disease: Failure to achieve complete response or partial response|Up to 38 months|Evaluable participants with known Clinical Response.||Participants|||Number
662109|NCT01829477|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|The change between the fasting plasma glucose value collected at week 24 or final visit relative to baseline.|Baseline and Week 24|In accordance with the SAP, due to the limited enrollment at the time of study termination, the summaries and statistical analyses of primary and secondary efficacy parameters originally intended and described in the protocol were not produced.|||||
662110|NCT01829477|Secondary|Percentage of Participants With HbA1c <7 % at Week 24.||Week 24|In accordance with the SAP, due to the limited enrollment at the time of study termination, the summaries and statistical analyses of primary and secondary efficacy parameters originally intended and described in the protocol were not produced.|||||
662111|NCT01829477|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 24 relative to baseline.|Baseline and Week 24|In accordance with the Statistical Analysis Plan (SAP), due to the limited enrollment at the time of study termination, the summaries and statistical analyses of primary and secondary efficacy parameters originally intended and described in the protocol were not produced.|||||
662112|NCT01829464|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|The change between the fasting plasma glucose values collected at Week 24 relative to baseline.|Baseline and Week 24|FAS included all randomized participants who received at least 1 dose of double blind study medication and who had a baseline and at least 1 post-baseline assessment.||milligram per deciliter (mg/dL)||Standard Deviation|Mean
662113|NCT01829464|Secondary|Percentage of Participants With HbA1c <7%||Week 24|Due to the relatively limited enrollment and follow-up at the time of study termination, the analysis of percentage of participants with HbA1c <7% at Week 24 was not performed.|||||
662132|NCT01828476|Secondary|Biomarkers of Autophagy Modulation by EM; and LC3, and/or p62 by Immunoblotting in PBMC and Tumor Tissue When Available||5 years|Study was terminated early and insufficient data was collected to assess this outcome measure.|||||
662114|NCT01829464|Primary|Change From Baseline in HbA1c at Week 24|The change in the value of HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 24 relative to baseline.|Baseline and Week 24|Full analysis set (FAS) included all randomized participants who received at least 1 dose of double blind study medication and who had a baseline and at least 1 post-baseline assessment.||Percentage of glycosylated haemoglobin||Standard Deviation|Mean
662115|NCT01829399|Secondary|Pain Score at Time of Tq Deflation|A visual analog pain score (VAS) from 0 to 10 was assessed at the time of Tq deflation. 0 indicating no pain, and 10 indicating the worst possible pain. All participants requested deflation prior to the maximum allowable 60 minutes, Subjects were instructed to request deflation at the same degree of discomfort for each visit. Due to a strong crossover effect, only the data assessed from the first intervention was analyzed.|Tq will be deflated upon subject's request. VAS is assessed at time of deflation for degree of discomfort prompting deflation request, up to 60 minutes post intervention.|||scores on a scale||95% Confidence Interval|Mean
662116|NCT01829399|Primary|Time in Minutes That Tq Remained Inflated|15 minutes after either Bupivacaine or placebo injection, Tq was inflated to 100 mm Hg over subjects systolic blood pressure. When the subject found the Tq too uncomfortable, the Tq was deflated and the time documented. Approximately one month later, each subject had the opposite injection of either placebo or Bupivacaine on the same arm, and the duration of Tq inflation was again measured. Due to a strong crossover effect, only the data assessed from the first intervention was analyzed.|Tq was inflated 15 minutes after injection of Bupivacaine or placebo and remained inflated until subject could no longer tolerate it. Maximum allowable inflation time per session was 60 minutes.|||Minutes||95% Confidence Interval|Mean
662117|NCT01829243|Secondary|MATRICS Consensus Cognitive Battery Composite Score|"(MATRICS) Consensus Cognitive Battery measures cognitive functioning within 7 domains: speed of processing, attention/vigilance, working memory (non verbal and verbal), verbal learning, visual learning, reasoning and problem solving and social cognition.
The composite score is calculated by the MATRICS computer program, which equally weights each of the 7 domain scores. The range of composite scores is 20-80. Higher scores indicate higher levels or cognitive functioning, while lower scores indicate lower levels of cognitive functioning."|Baseline, Week 6|||units on a scale||Standard Deviation|Mean
662118|NCT01829243|Primary|Composite Brief Assessment of Cognition (BAC) Score|The composite BAC score is calculated by scoring each of the 6 individual tests (Verbal Memory Recall, Digit Sequencing, Token Motor Task, Verbal Fluency, Symbol Coding, and Tower of London), comparing each score to a healthy control sample to create z-scores, summing the z-scores, and rescaling the sum. The composite score range is -2127.8 to 1878.8, with higher scores indicating better cognition.|Baseline, Week 6|||units on a scale||Standard Deviation|Mean
662119|NCT01829243|Primary|Changes in The Fatigue Severity Scale (FSS)|"The Fatigue Severity Scale (FSS) is composed of nine items with a seven-point response format. The minimum score = 9 and maximum score possible = 63. Higher scores = greater fatigue severity.
Sample questions include I am easily fatigued and Exercise brings on my fatigue. In the initial validation study, internal consistency for the Fatigue Severity Scale was high for specific illness groups (MS and lupus) and healthy controls. The scale clearly distinguished patients from controls and it was moderately correlated with a single-item visual analogue scale of fatigue intensity. In all patients, clinical improvement in fatigue was associated with reductions in scores on the Fatigue Severity Scale. The Fatigue Severity Scale is also a practical measure due to its brevity and ease of administration and scoring."|Baseline, Week 1, 2,4, and 6 weeks|Analysis employed Intent-to-Treat with Last Observation Carried Forward (LOCF) analysis. The Intent-to-Treat group (ITT) was comprised of all subjects who received at least one dose of the medication.||units on a scale||Full Range|Mean
662120|NCT01829243|Primary|Visual Analogue Scale for Pain|Visual Analogue Scale for Pain operationally is a 100 mm line anchored by word descriptors at each end. The patient marks a point on the line that reflects their current pain state. The distance in mm from the left anchor point is the score. Higher scores indicate more pain.|Baseline, Week 1, 2,4, and 6 weeks|Analysis employed Intent-to-Treat with Last Observation Carried Forward (LOCF) analysis. The Intent-to-Treat group (ITT) was comprised of all subjects who received at least one dose of the medication.||mm||Full Range|Mean
662121|NCT01829230|Primary|Spherical Equivalent Refractive Error|Cycloplegic spherical equivalent refraction of the subjects's right eye was computed from the sphero-cylindrical refraction measured with an open-field auto refractor. The median of 5 repeated measurements, each of which was the average of 3 consecutive readings, was used for the analysis.|Baseline and every 6 months up to 18 months|All subjects who have at least one data point.||diopter (D)||Standard Deviation|Mean
662122|NCT01829230|Primary|Axial Length of the Eye|Axial length was measured with the IOLMaster at baseline and then every 6 months throughout the course of the study. Five measurements were collected at each visit from the subject's right eye and the average of the 5 measurements was used for the analysis.|Baseline and every 6 months post-baseline up to 18 months|All subjects who have at least one data point.||millimeter (mm)||Standard Deviation|Mean
662123|NCT01829191|Secondary|Axial Length|Axial length was measured with the IOLMaster at baseline and every 6 months for 2 years. Five measurements were collected for each visit from the subject's right eye and the average of the five measurements was used for the analysis.|Baseline and every 6 months for 2 years|Analysis was conducted on all randomized subjects who have at least one data point.||millimeter (mm)||Standard Deviation|Mean
662124|NCT01829191|Primary|Spherical Equivalent Refractive Error|Cycloplegic spherical equivalent auto refraction of the subject's right eye was computed from the sphero-cylindrical refraction measured with an open-field auto refractor. The median of 3 repeated measures, each of which was the average of 3 consecutive readings, was used for the analysis. Higher values in spherical refraction indicate progression in Myopia.|Baseline and every 6 months post-baseline for 2 years|Analysis was conducted on all randomized subjects who have at least one data point.||diopter (D)||Standard Error|Mean
662125|NCT01828593|Other Pre-specified|Change From Baseline in Duodenal Gut-associated Lymphoid Tissue (GALT) CD4+ T Cell Densities||Baseline and Week 24|Sub-study||cells/mm3||Full Range|Mean
662126|NCT01828593|Other Pre-specified|Change From Baseline in Peripheral CD4+ T Cell Counts in 4th Baseline CD4+ Quartile (Greater Than 893)|4th Baseline CD4+ Quartile (greater than 893)|Baseline and 4 weeks|||cells/microliter||Standard Deviation|Mean
662133|NCT01828476|Secondary|Bcl-2 Family Protein Expression (Bcl-2, Bcl-XL, MCL-1) in Paraffin Blocks When Available by Immunohistochemistry||5 years|Study was terminated warly and insufficient data was collected to assess this outcome measure.|||||
662138|NCT01828476|Primary|Biochemical Response to ABT-263 and Abiraterone and to ABT-263 in Combination With Hydroxychloroquine and Abiraterone in Patients That Are Progressing on Abiraterone|"Characterize biochemical response to ABT-263 and Abiraterone and to ABT-263 in combination with hydroxychloroquine and Abiraterone by looking at PSA levels."|5 years|Study was terminated early and insufficient data was collected to assess this outcome measure.||Participants|||Count of Participants
662139|NCT01828281|Other Pre-specified|Mean Hours of CPAP Usage Per Day|Mean Hours of CPAP usage per day in those who continue to use CPAP during the three month period.|3 months|||hours||Standard Deviation|Mean
662140|NCT01828281|Secondary|Mean Changes in Adiponectin Over 3 Months|Mean changes in Adiponectin from baseline to 3 months.|Baseline, 3 months|||ug/ml||Standard Deviation|Mean
662141|NCT01828281|Primary|Mesenteric Fat Thickness||3 months|||cm||Standard Deviation|Mean
662142|NCT01828216|Secondary|Difference in Healthcare Costs Between Ambulatory and Hospital Approach||within 24 months|||Hong Kong Dollars||Standard Deviation|Mean
662143|NCT01828216|Primary|Change in Epworth Sleepiness Score (ESS) Before and After 3 Months of Continuous Positive Airway Pressure (CPAP) Treatment|The Epworth Sleepiness Scale (ESS) is a scale intended to measure daytime sleepiness that is measured by use of a very short questionnaire. The questionnaire asks the subject to rate his or her probability of falling asleep on a scale of increasing probability from 0 to 3 for eight different situations that most people engage in during their daily lives, though not necessarily every day. The scores for the eight questions are added together to obtain a single number. A number in the 0–9 range is considered to be normal while a number in the 10–24 range indicates that expert medical advice should be sought.|Baseline and 3 months|Following detection of apnea-hypopnea index (AHI) of 15 events per hour or more by home sleep study or polysomnography, patients received CPAP therapy for 3 months after an overnight autoCPAP titration at in-hospital or ambulatory home setting.||units on a scale||Standard Deviation|Mean
662144|NCT01828164|Secondary|Discomfort|Average measured level of subject discomfort or pain. The Participant Pain Reporting Scale is used to assess the amount of pain on a 10 point scale. On the 10 point scale, 1 represents the least amount of pain and 10 represents the most amount of pain.|24 weeks or until the extraction space was closed (whichever came first)|Subjects who completed the study with device usage compliance of 67% or higher.||units on a scale||Standard Deviation|Mean
662145|NCT01828164|Secondary|Rate of Root Resorption|The weekly rate of tooth root resorption (mm/week) as compared between the treated side and the control side.|24 weeks or until the extraction space was closed (whichever came first)|Subjects who completed the study with device usage compliance of 67% or higher and with functional devices were evaluated. Only subjects with CBCT images were used.||mm/week||Standard Deviation|Mean
662146|NCT01828164|Primary|Rate of Tooth Movement|The weekly rate of tooth movement (mm/week) as compared between the treated side and the control side.|24 weeks or until the extraction space was closed (whichever came first)|As per approved protocol, only subjects who completed the study with device usage compliance of 67% or higher and with functional devices were evaluated.||mm/week||Standard Deviation|Mean
662147|NCT01828112|Secondary|Duration of Intracranial Response (DOIR)|DOIR is defined as the DOR based on lesions in brain (target, non-target lesions (and new lesions, if applicable) and calculated from the time of first documented response of CR or PR to the date of the first documented disease progression in the brain or death due to any cause per modified RECIST 1.1* as assessed by BIRC neuro-radiologist.|Screening, followed by every 6 weeks until Month 18 after Month 18 every 9 weeks||10/2019||||
662148|NCT01828112|Secondary|Intracranial Disease Control Rate (IDCR)|IDCR is defined as the DCR based on lesions in brain (target, non-target lesions (and new lesions, if applicable) and calculated as the proportion of patients with a best overall response of CR or PR or SD (or non-CR/nonPD) in the brain per modified RECIST 1.1* as assessed by BIRC neuro-radiologist.|Screening, followed by every 6 weeks until Month 18 after Month 18 every 9 weeks||10/2019||||
662149|NCT01828112|Secondary|Overall Intracranial Response Rate (OIRR)|OIRR is defined as the ORR based on lesions in brain (target, nontarget lesions (and new lesions, if applicable) and calculated as the proportion of patients with a best overall confirmed response of CR or PR in the brain per modified RECIST 1.1* as assessed by BIRC neuroradiologist.|Screening, followed by every 6 weeks until Month 18 after Month 18 every 9 weeks||10/2019||||
662150|NCT01828112|Secondary|Time to Definitive Deterioration||from the date of randomization to the date of event for disease related symptoms||10/2019||||
662151|NCT01828112|Secondary|Patient Reported Outcomes (PRO)||Screening, followed by every 6 weeks until Month 18 after Month 18 every 9 weeks||10/2019||||
662152|NCT01828112|Secondary|Time to Response (TTR)|TTR is defined as the time from date of randomization to date of first documented response (CR or PR)|Month 18||10/2019||||
662153|NCT01828112|Secondary|Disease Control Rate (DCR)|DCR is defined as the proportion of patients with best overall response of CR, PR, or stable disease (SD)|Month 18||10/2019||||
662154|NCT01828112|Secondary|Duration of Response (DOR)|DOR is defined as the time from date of first documented CR or PR to date of first documented disease progression or death due to underlying cancer|Month 18||10/2019||||
662155|NCT01828112|Secondary|Overall Response Rate (ORR)|ORR is defined as the proportion of patients with a best overall response defined as complete response (CR) or partial response (PR); (CR+PR)|Month 18||10/2019||||
662156|NCT01828112|Secondary|Overall Survival (OS)|OS is defined as time from date of randomization to date of death due to any cause.|Month 18||10/2019||||
662157|NCT01828112|Primary|Progression Free Survival (PFS) Blinded Independent Review Committee Per Blinded Independent Review Committee (BIRC)|PFS is defined as the time from the date of randomization to the date of the first radiologically documented disease progression or death due to any cause.|’from the date of randomization to the date of first radiologically documented disease progression or death due to any cause up to approximately 24 months|The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization.||Percentage of participants||95% Confidence Interval|Median
662158|NCT01828099|Secondary|Patient Reported Outcomes|The time to definitive deterioration from the date of randomization to the date of event for disease related symptoms.|Screening, followed by every 6 weeks until Month 33 after Month 33 every 9 weeks.||06/2018||||
662159|NCT01828099|Secondary|Time to Response (TTR)|TTR defined as the time from date of randomization to date of first documented response (CR or PR)|From randomization until death (up to approximately 34 months)||06/2018||||
662162|NCT01828099|Secondary|Overall Response Rate (ORR)|ORR defined as the proportion of patients with a best overall response defined as Complete Response (CR) or Partial Response (PR) as evaluated by Blinded Independent Review Committee (BIRC) and by investigator assessment per RECIST 1.1|From randomization until death (up to approximately 34 months)||06/2018||||
662163|NCT01828099|Secondary|Overall Survival (OS)|OS defined as time from date of randomization to date of death due to any cause|From randomization until death (up to approximately 34 months)||06/2018||||
662164|NCT01828099|Primary|Progression Free Survival (PFS) by Blinded Independent Review Committee (BIRC)|PFS defined as time from date of randomization to date of first documented disease (as assessed by Blinded Independent Review Committee (BIRC) per RECIST 1.1) or date of death due to any cause|from the date of randomization to the date of first radiologically documented disease progression or death due to any cause (assessed every 6 weeks up to approximately 34 months)|The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization. According to the intent to treat principle, patients were analyzed according to the treatment and strata to which they had been assigned during the randomization procedure.||months||95% Confidence Interval|Median
662165|NCT01827839|Secondary|Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|Starting after 30 days post last vaccination until study end (i.e. Month 14)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.||Participants|||Count of Participants
662166|NCT01827839|Secondary|Number of Subjects With SAEs|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Starting after 30 days post last vaccination until study end (i.e. Month 14)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.||Participants|||Count of Participants
662167|NCT01827839|Secondary|Number of Subjects With Anti-gE Antibody Concentrations Equal to or Above the Cut-off Value|The cut-off value was 97 mIU/mL.|At Month 0 and at Month 3|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.||Participants|||Count of Participants
662168|NCT01827839|Secondary|Anti-gE Antibody Concentrations|Anti-gE antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). The outcome was assessed in each of the following age ranges: 50-59 YOA, 60-69 YOA and ≥ 70 YOA, in terms of antibody concentrations.|At Month 0 and at Month 3|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.||mIU/mL||95% Confidence Interval|Geometric Mean
662169|NCT01827839|Primary|Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|From first vaccination up to 30 days post last vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.||Participants|||Count of Participants
662170|NCT01827839|Primary|Number of Subjects With Any Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From first vaccination up to 30 days post last vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered.||Participants|||Count of Participants
662171|NCT01827839|Primary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|Within 30 days (Days 0-29) after each vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered.||Participants|||Count of Participants
662172|NCT01827839|Primary|Number of Days With Solicited General Symptoms|The number of days with general symptoms during the solicited post-vaccination period.|Within 7 days (Day 0-6) after each vaccine dose|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and with results available for this assessment.||Days||Inter-Quartile Range|Median
662173|NCT01827839|Primary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal (nausea, vomiting, diarrhoea and/or abdominal pain), headache, myalgia, shivering and temperature [defined as oral temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = temperature > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|Within 7 days (Day 0-6) after each vaccine dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and with the symptoms sheet filled in.||Participants|||Count of Participants
662174|NCT01827839|Primary|Number of Days With Solicited Local Symptoms|The number of days with any local symptoms during the solicited post-vaccination period.|Within 7 days (Day 0-6) after each vaccine dose|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered and with results available for this assessment.||Days||Inter-Quartile Range|Median
662198|NCT01827462|Secondary|Number of Participants With Related Adverse Events|Related adverse events were recorded annually during this 10 year longitudinal study.|Day 0 to Day 28 following each annual vaccination while on study|||Participants|||Count of Participants
662199|NCT01827462|Primary|Number of Participants Who Received the Influenza Vaccine||Day 0 annually while on study|||Participants|||Count of Participants
662175|NCT01827839|Primary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|Within 7 days (Day 0-6) after each vaccine dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered and with the symptoms sheet filled in.||Participants|||Count of Participants
662176|NCT01827839|Primary|Number of Vaccine Responders for Anti-gE Antibodies as Determined by ELISA|"Vaccine response was defined as:
For initially seronegative subjects, antibody concentration at post-vaccination ≥ 4 fold the cut-off for anti-gE [4x97 milli-international units per milliliter (mIU/mL)]; For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration."|At Month 3|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.||Participants|||Count of Participants
662177|NCT01827670|Secondary|Mean Change in Dentinal Hypersensitivity After 8 Weeks as Measured by Visual Analog Scale (VAS)|The subject rated the intensity of their response to the evaporative air stimulus by rating the intensity of their response to the stimulus using a 100 millimeter (mm )VAS Scale 0 is No Pain and 100 is Worst Pain Imaginable A trained member of staff measured the line segment marked off in mm and recorded this measurement in the CRF|Baseline - Week 8|Efficacy assessments were based on intent-to-treat (ITT) population, defined as all randomized participants, administered at least one dose of study treatment providing at least one post-baseline assessment of efficacy. One participant was lost to follow-up after visit 2 in test dentifrice group but was included in the efficacy analysis at visit 2||Score on a Scale||Standard Deviation|Mean
662178|NCT01827670|Secondary|Mean Change in Dentinal Hypersensitivity After 4 Weeks as Measured by Visual Analog Scale (VAS)|The subject rated the intensity of their response to the evaporative air stimulus by rating the intensity of their response to the stimulus using a 100 millimeter (mm )VAS Scale 0 is No Pain and 100 is Worst Pain Imaginable A trained member of staff measured the line segment marked off in mm and recorded this measurement in the CRF|Baseline-Week 4|Efficacy assessments were based on intent-to-treat (ITT) population, defined as all randomized participants, administered at least one dose of study treatment providing at least one post-baseline assessment of efficacy. One participant was lost to follow-up after visit 2 in test dentifrice group but was included in the efficacy analysis at visit 2||Score on a Scale||Standard Deviation|Mean
662179|NCT01827670|Secondary|Mean Change From Baseline in Tactile Sensitivity|"The examiner assessed the tactile sensitivity of eligible teeth using a Yeaple probe. The constant pressure applied by Yeaple probe probe allowed the examiner to vary the force applied to the dentin surface from 10g to an upper threshold of 80g, in increments of 10g. The greater the pressure the participant was able to tolerate, the less sensitive the tooth was considered. Testing began at 10g and increased by 10g, with each successive challenge, until either a yes response (pain was elicited) was recorded or the maximum force has been reached."|Baseline-Week 4|Efficacy assessments were based on intent-to-treat (ITT) population, defined as all randomized participants, administered at least one dose of study treatment providing at least one post-baseline assessment of efficacy. One participant was lost to follow-up after visit 2 in test dentifrice group but was included in the efficacy analysis at visit 2||Grams||Standard Deviation|Mean
662180|NCT01827670|Secondary|Mean Change From Baseline in Tactile Sensitivity|"The examiner assessed the tactile sensitivity of eligible teeth using a Yeaple probe. The constant pressure applied by Yeaple probe probe allowed the examiner to vary the force applied to the dentin surface from 10g to an upper threshold of 80g, in increments of 10g. The greater the pressure the participant was able to tolerate, the less sensitive the tooth was considered. Testing began at 10g and increased by 10g, with each successive challenge, until either a yes response (pain was elicited) was recorded or the maximum force has been reached."|Baseline-Week 8|Efficacy assessments were based on intent-to-treat (ITT) population, defined as all randomized participants, administered at least one dose of study treatment providing at least one post-baseline assessment of efficacy. One participant was lost to follow-up after visit 2 in test dentifrice group but was included in the efficacy analysis at visit 2||Grams||Standard Deviation|Mean
662181|NCT01827670|Secondary|Mean Change From Baseline in Schiff Sensitivity Score|"The examiner conducted the evaporative air sensitivity assessment and scored the subject’s response to the sensitivity stimulus using the four-point categorical Schiff Sensitivity Scale (SSS).
Score 0 = Subject does not respond to air stimulus Score 1 = Subject responds to air stimulus, but does not request discontinuation of stimulus Score 2 = Subject responds to air stimulus, and requests discontinuation or moves from stimulus Score 3 = Subject responds to air stimulus, considers stimulus to be painful, and requests discontinuation"|Baseline-Week 4|Efficacy assessments were based on intent-to-treat (ITT) population, defined as all randomized participants, administered at least one dose of study treatment providing at least one post-baseline assessment of efficacy. One participant was lost to follow-up after visit 2 in test dentifrice group but was included in the efficacy analysis at visit 2||Score on a Scale||Standard Deviation|Mean
662182|NCT01827670|Primary|Mean Change From Baseline in Schiff Sensitivity Score|"The examiner conducted the evaporative air sensitivity assessment and scored the subject’s response to the sensitivity stimulus using the four-point categorical Schiff Sensitivity Scale (SSS).
Score 0 = Subject does not respond to air stimulus Score 1 = Subject responds to air stimulus, but does not request discontinuation of stimulus Score 2 = Subject responds to air stimulus, and requests discontinuation or moves from stimulus Score 3 = Subject responds to air stimulus, considers stimulus to be painful, and requests discontinuation"|Baseline-Week 8|Efficacy assessments were based on intent-to-treat (ITT) population, defined as all randomized participants, administered at least one dose of study treatment providing at least one post-baseline assessment of efficacy. One participant was lost to follow-up after visit 2 in test dentifrice group but was included in the efficacy analysis at visit 2||Score on a scale||Standard Deviation|Mean
662207|NCT01827358|Secondary|Median Time to Occurrence of Non-S. Aureus (SA) Clinical Infection in the Treatment Compared to Control Group|Median time to occurrence of non-SA clinical infection in the treatment compared to control group as estimated using Kaplan-Meier estimates of the survival curves.|Day 1 through 85|Clinical infection besides SA infection on or prior to Day 85 was not observed frequently enough to allow estimation of the median time to infection using non-parametric methods.|||||
662183|NCT01827592|Secondary|Change From Baseline in Weekly Abdominal Discomfort Score|"The abdominal discomfort score was measured using the five-point ordinal scale (1=None, 2=Mild, 3=Moderate, 4=Severe, and 5=Very severe).
For a given assessment week, the weekly abdominal discomfort score was defined as the sum of non-missing abdominal discomfort score for SBMs during that week divided by the number of non-missing abdominal discomfort score for SBMs during that week. The parameter was analysed using repeated measures ANCOVA model."|From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period|The ITT analysis set consisted of all randomized (as planned) patients.||Units on a scale||95% Confidence Interval|Least Squares Mean
662184|NCT01827592|Secondary|Change From Baseline in Weekly Abdominal Bloating Score|"The abdominal bloating score was measured using the five-point ordinal scale (1=None, 2=Mild, 3=Moderate, 4=Severe, and 5=Very severe).
For a given assessment week, the weekly abdominal bloating score was defined as the sum of non-missing abdominal bloating score for SBMs during that week divided by the number of non-missing abdominal bloating score for SBMs during that week. The parameter was analysed using repeated measures ANCOVA model."|From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period|The ITT analysis set consisted of all randomized (as planned) patients.||Units on a scale||95% Confidence Interval|Least Squares Mean
662185|NCT01827592|Secondary|Change From Baseline in Weekly Degree of Straining of SBMs|"The degree of straining was measured using the five-point ordinal scale (1=Not at all, 2=A little bit, 3=A moderate amount, 4=A great deal, and 5=An extreme amount).
For a given assessment week, the weekly degree of straining was defined as the sum of non-missing straining score for SBMs during that week divided by the number of non-missing straining score for SBMs during that week. The parameter was analysed using repeated measures ANCOVA model."|From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period|The ITT analysis set consisted of all randomized (as planned) patients.||Units on a scale||95% Confidence Interval|Least Squares Mean
662186|NCT01827592|Secondary|Total Patient Assessment of Constipation – Quality of Life (PAC-QOL) Score Responder|"This outcome measured the percentage of patients who were PAC-QOL score responder at 12-week of Treatment Period. A PAC-QOL score responder was defined as a patient with ≥50% reduction in total PAC-QOL score from Baseline at Week 12.
PAC-QOL is a 28-item questionnaire for psychometric assessment of disease-specific quality of life. The questionnaire is based on 5-point Likert scale; ranging from 0 [none of the time or not at all] to 4 [all of the time or extremely]). A lower score indicates a better Quality of Life. The PAC-QOL questionnaire is developed specifically for patients with constipation.
Total PAC-QOL score was averaged from the individual item score."|At 12 weeks|The ITT analysis set consisted of all randomized (as planned) patients.||Percentage of patients|||Number
662187|NCT01827592|Secondary|Change From Baseline in Weekly Stool Consistency of SBMs|"The stool consistency is measured using the seven-point ordinal Bristol Stool Form Scale (BSFS) score. The BSFS classifies human stool into seven types and points them accordingly.
Type 1: Separate hard lumps, like nuts (hard to pass) Type 2: Sausage-shaped, but lumpy Type 3: Like a sausage but with cracks on its surface Type 4: Like a sausage or snake, smooth and soft Type 5: Soft blobs with clear cut edges (passed easily) Type 6: Fluffy pieces with ragged edges, a mushy stool Type 7: Watery, no solid pieces, entirely liquid Types 1 and 2 indicate constipation, with 3 and 4 represents the ideal stool form (especially the latter), and 5, 6 and 7 tends towards diarrhoea .
For a given assessment week, the weekly stool consistency was defined as the sum of non-missing stool consistency score for SBMs during that week divided by the number of non-missing stool consistency score for SBMs during that week. The parameter was analysed using repeated measures ANCOVA model."|From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period|The ITT analysis set consisted of all randomized (as planned) patients.||Units on BSFS||95% Confidence Interval|Least Squares Mean
662188|NCT01827592|Secondary|Change From Baseline in Weekly Frequency of Spontaneous Bowel Movements (SBMs)|The change from Baseline for the continuous variable was estimated using a repeated measures analysis of covariance (ANCOVA) model.|From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period|The ITT analysis set consisted of all randomized (as planned) patients.||SBM per week||95% Confidence Interval|Least Squares Mean
662189|NCT01827592|Secondary|Occurrence of CSBM Response|This outcome measured the percentage of patients who had a CSBM within 24 hours after the first dose of treatment. A CSBM was defined as a spontaneous (occurring without laxative within the preceding 24 hours, including no rescue medication within the preceding 24 hours) bowel movement (as interpreted by the patient, with a beginning and an end, including single or multiple stools), accompanied by a patient reported sense of complete evacuation (‘complete’).|Within the first 24 hours of treatment initiation|The ITT analysis set consisted of all randomized (as planned) patients was used for assessment.||Percentage of patients|||Number
662190|NCT01827592|Primary|Overall Complete Spontaneous Bowel Movement (CSBM) Response|This outcome measured the percentage of patients who were CSBM responders. A CSBM responder was defined as a patient with ≥3 CSBMs per week and an increase of ≥1 CSBM per week from Baseline, for at least 9 of the 12 weeks in the 12-week Treatment Period, including at least 3 weeks during Weeks 9-12.|During the first 12 weeks|Intention-to-treat (ITT) analysis set consisted of all randomized (as planned) patients.||Percentage of patients|||Number
662191|NCT01826370|Secondary|Change From Baseline to Week 24 of Fasting Blood Sugar|Change from baseline to week 24 of fasting blood sugar|Baseline and 24 weeks|Effectiveness analysis set which included patients with complete baseline and follow up secondary outcomes. For this outcome measure this include patients with baseline and end-point data for fasting blood sugar.||mg/dl||Standard Deviation|Mean
662192|NCT01826370|Secondary|Change From Baseline to Week 24 of HbA1c|Change from baseline to week 24 of glycosylated hemoglobin (HbA1c)|Baseline and 24 weeks|Effectiveness analysis set which included patients with complete baseline and follow up secondary outcomes. For this outcome measure this include patients with baseline and end-point data for HbA1c.||percentage of HbA1c||Standard Deviation|Mean
662193|NCT01826370|Primary|Frequency of Adverse Events and Serious Adverse Events|Frequency of adverse events and serious adverse events in an actual clinical setting, including hypoglycemic events.|Week 24|Safety analysis set which consisted of all patients who have taken at least one dose of linagliptin and participated in the follow-up visit, thus, having a baseline and end-point evaluation.||percentage of participants|||Number
662194|NCT01827475|Secondary|Need for Rescue Pain Relief|The need for additional analgesics|1 hour|||participants|||Number
662195|NCT01827475|Primary|Pain Severity|Pain score on 100 mm VAS from 0 (no pain) to 100 (worst pain)|1 hour|||mm||95% Confidence Interval|Mean
662200|NCT01827371|Secondary|Number of Subjects Experiencing Serious Adverse Events (SAEs) Associated With IMVAMUNE|"Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation thereof; was a congenital anomaly/birth defect; or may have jeopardized the participant, or required intervention to prevent one of the outcomes. Association with IMVAMUNE was determined by the investigator and defined as Related, meaning a reasonable possibility that the study product caused the adverse event. Reasonable possibility was defined as there being evidence to suggest a causal relationship between the study product and the adverse event."|Day 1 after the first vaccination through 180 days after the 2nd vaccination.|All subjects receiving at least one vaccination are included in the analysis population 'as treated', so one subject randomized to Arm C vaccinated out of window, equivalent to the schedule for Arm A, was analyzed for this outcome measure as Arm A.||participants|||Number
662201|NCT01827371|Secondary|Geometric Mean Peak ELISA Titer After Second Vaccination|Blood was collected from all participants at 8, 15, 22 and 29 days after receipt of the second vaccination for assessment of antibody titers by ELISA. The peak titer for each participant was defined as the highest titer among all available measurements post second vaccination. The geometric mean for each group was then assessed from individual participants' peak titers.|Day 7 through 31 after the 2nd vaccination|The modified ATP population was defined as all participants who received both vaccinations in window, excluding those who did not have a complete dose delivered or received non-study vaccinations. Only measurements (blood draws) between Days 7-31 were considered and subjects had to have at least two measurements in that range to be included.||titers||95% Confidence Interval|Geometric Mean
662202|NCT01827371|Primary|Percentage of Participants Reporting Moderate or Severe Solicited Local Injection Site Reactions After Receiving Vaccine Via the Stratis™ Compared to Syringe and Needle Administration|Participants maintained a memory aid to record daily the occurrence of local injection site reactions for 15 days after vaccination based on their interference with daily activities (pain and itchiness at injection site, underarm pain and swelling) or based on a quantitative measurement of the reaction (redness, swelling). In the subjective grading scale, severe reactions prevented daily activities, moderate reactions interfered with but did not prevent daily activities, and mild reactions were present but did not interfere with daily activities. For the quantitative scale, severe reactions greater than 30 millimeters (mm), moderate reactions were 15-30mm, and mild reactions were 1-15mm. Participants are counted by the maximum severity on any of the 15 days, and for this outcome measure, only those reporting moderate or severe events are counted. Formal comparisons by Fisher's Exact test were conducted for Arm D (Stratis, Day 1,29) compared to A|15 days after each vaccination|All subjects receiving at least one vaccination are included in the analysis population 'as treated', so one subject randomized to Arm C vaccinated out of window, equivalent to the schedule for Arm A, was analyzed for this outcome measure as Arm A.||percentage of participants|||Number
662203|NCT01827371|Primary|Geometric Mean Peak Plaque Reduction Neutralization Titer (PRNT) After Second Vaccination|Blood was collected from all participants at 8, 15, 22 and 29 days after receipt of the second vaccination for assessment of plaque reduction neutralization titers. The peak titer for each participant was defined as the highest titer among all available measurements post second vaccination. The geometric mean for each group was then assessed from individual participants' peak titers.|Day 7 through Day 31 after 2nd vaccination|The modified ATP population was defined as all participants who received both vaccinations in window, excluding those who did not have a complete dose delivered or received non-study vaccinations. Only measurements (blood draws) between Days 7-31 were considered and subjects had to have at least two measurements in that range to be included.||titers||95% Confidence Interval|Geometric Mean
662204|NCT01827358|Secondary|Time Until Decolonization: Count of Participants From Day 1 Until the First NUP Collection With no SA is Detected in the Nares, Umbilical, and Perianal Areas Using the According to Protocol Day 8 (ATP-8) Cohort.|Time until decolonization: Count of participants from Day 1 until the first NUP collection with no SA is detected in the nares, umbilical, and perianal areas using the according to protocol day 8 (ATP-8) cohort. The time periods in the table correspond to the study days having scheduled collection of nasal, umbilical, and perianal (NUP) cultures. At risk participants were eligible for the SA decolonization to occur at the start of the interval, were still on study and had not yet had SA decolonization but were still being watched for the event. SA decolonization was the absence of SA detected from the NUP cultures through direct plating. Censored participants were at risk for some of the interval, did not have SA decolonization but were removed from eligibility for the event at some point after the interval started.|Day 1 through 85|The ATP-8 cohort includes all ATP infants who had a set of NUP cultures collected on Day 8 (± 2).||Participants|||Count of Participants
662205|NCT01827358|Secondary|Time Until Decolonization: Count of Participants From Day 1 Until the First NUP Collection With no S. Aureus (SA) Detected in the Nares, Umbilical, and Perianal Areas Using the Modified Intent to Treat Day 8 Cohort (mITT-8).|Time until decolonization: Count of participants from Day 1 until the first NUP collection with no SA is detected in the nares, umbilical, and perianal areas using the modified intent to treat (mITT-8) cohort. The time periods in the table correspond to the study days having collection of nasal, umbilical, and perianal (NUP) cultures. At risk participants were eligible for the SA decolonization to occur at the start of the interval, were still on study and had not yet had SA decolonization but were still being watched for the event. SA decolonization was the absence of SA detected from the NUP cultures through direct plating. Censored participants were at risk for some of the interval, did not have SA decolonization but were removed from eligibility for the event at some point after the interval started.|Day 1 through 85|The mITT cohort includes all infants with a site-specific pre-randomization NUP culture that was positive for SA by direct culture. The mITT-8 cohort includes all mITT infants who either had a complete set of NUP cultures collected on day 8 or else had discontinuation of NUP cultures prior to Day 8 due to a clinical SA infection.||Participants|||Count of Participants
662206|NCT01827358|Secondary|Relative Risk of Severe (Stage II-III) Necrotizing Enterocolitis (NEC) in the Treatment Compared to Control Group|The association between mupirocin treatment and severe (stage II-III) NEC on or before Day 85 was to be assessed via Cox Proportional Hazards Model.|Day 1 through 85|There were no events of necrotizing enterocolitis during the study, analysis could not be performed.|||||
662291|NCT01825122|Primary|Change From Baseline in the Average Number of Cigarettes Smoked Per Day||Baseline to end of treatment, up to 15 weeks|The analysis population reflects all patients who achieved maintenance dosing, including those who did not complete the study||participants|||Number
662208|NCT01827358|Secondary|Protective Efficacy of Clinical SA Infection in the Treatment Compared to the Control Group During Days 1-22 or Until Discharge, Whichever Occurs First, Using the According to Protocol (ATP) Cohort.|Protective efficacy of clinical SA infection in the treatment compared to the control group during days 1-22 or until discharge, whichever occurs first using the ATP cohort. The time periods in the table correspond to the study days having scheduled collection of nasal, umbilical, and perianal (NUP) cultures. At risk participants were eligible for the SA clinical infection to occur at the start of the interval, were still on study and had not yet had a SA clinical infection but were still being watched for the event. SA clinical infection was the development of a SA clinical infection due to an identifiable organism as evidenced by culture of an organism from a normally sterile body site or an infant who met the clinical diagnosis of localized infection as defined in the protocol. Censored participants were at risk for some of the interval, did not have a SA clinical infection but were removed from eligibility for the event at some point after the interval started.|Day 1 through 22|The ATP cohort includes all infants that have met all requirements of the mITT cohort, with the further requirements that infants in the mupirocin treatment group must have received a minimum of 10 complete mupirocin treatments, including at least one dose to all three NUP sites per day for five consecutive days during the treatment period.||Participants|||Count of Participants
662209|NCT01827358|Secondary|Protective Efficacy of Clinical S. Aureus (SA) Infection in the Treatment Compared to the Control Group During Days 1-22 or Until Discharge, Whichever Occurs First, Using the Intent to Treat Cohort.|Protective efficacy of clinical SA infection in the treatment compared to the control group during days 1-22 or until discharge, whichever occurs first using the intent to treat (ITT) cohort. The time periods in the table correspond to the study days having scheduled collection of nasal, umbilical, and perianal (NUP) cultures. At risk participants were eligible for the SA clinical infection to occur at the start of the interval, were still on study and had not yet had a SA clinical infection but were still being watched for the event. SA clinical infection was the development of a SA clinical infection due to an identifiable organism as evidenced by culture of an organism from a normally sterile body site or an infant who met the clinical diagnosis of localized infection as defined in the protocol. Censored participants were at risk for some of the interval, did not have a SA clinical infection but were removed from eligibility for the event at some point after the interval started.|Day 1 through 22|The ITT cohort included all randomized infants. The analyses on the ITT cohort were performed per randomized treatment assignment.||Participants|||Count of Participants
662210|NCT01827358|Secondary|Median Time to Occurrence of Severe (Stage II-III) Necrotizing Enterocolitis (NEC) in the Treatment Compared to Control Group.|Median time to occurrence of severe (stage II-III) NEC in the treatment compared to control group as estimated using Kaplan-Meier estimates of the survival curves.|Day 1 through 85|There were no events of necrotizing enterocolitis during the study, analysis could not be performed.|||||
662211|NCT01827358|Secondary|Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the According to Protocol Cohort.|Relative risk of occurrence of non-SA clinical infection in the treatment compared to control groups using the according to protocol (ATP) cohort. The time periods in the table correspond to the study days having scheduled collection of nasal, umbilical, and perianal (NUP) cultures. At risk participants were eligible for the non-SA clinical infection to occur at the start of the interval, were still on study and had not yet had a non-SA clinical infection but were still being watched for the event. Non-SA clinical infection was the development of a non-SA clinical infection due to an identifiable organism as evidenced by culture of an organism other than SA from a normally sterile body site or an infant who met the clinical diagnosis of localized infection as defined in the protocol. Censored participants were at risk for some of the interval, did not have a non-SA clinical infection but were removed from eligibility for the event at some point after the interval started.|Day 1 through 85|The ATP cohort includes all infants with a site-specific pre-randomization NUP culture that is positive for SA by direct culture, those in the mupirocin treatment group must have received a minimum of 10 complete mupirocin treatments, including at least one dose to all three NUP sites per day for five consecutive days during the treatment period.||Participants|||Count of Participants
662212|NCT01827358|Secondary|Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the Intent To Treat Cohort|Relative risk of occurrence of non-SA clinical infection in the treatment compared to the control group using the intent to treat (ITT) cohort for analysis. The time periods in the table correspond to the study days having scheduled collection of nasal, umbilical, and perianal (NUP) cultures. At risk participants were eligible for the non-SA clinical infection to occur at the start of the interval, were still on study and had not yet had a non-SA clinical infection but were still being watched for the event. Non-SA clinical infection was the development of a non-SA clinical infection due to an identifiable organism as evidenced by culture of an organism other than SA from a normally sterile body site or an infant who met the clinical diagnosis of localized infection as defined in the protocol. Censored participants were at risk for some of the interval, did not have a non-SA clinical infection but were removed from eligibility for the event at some point after the interval started.|Day 1 through 85|The ITT cohort included all randomized infants. The analyses on the ITT cohort were performed per randomized treatment assignment.||Participants|||Count of Participants
662213|NCT01827358|Primary|Persistent Decolonization Efficacy- Number of Participants in the Treatment and Control Groups Who Have no Detectable S. Aureus (SA) on Direct Nasal, Umbilical, and Perianal (NUP) Cultures on Days 8 and 22.|Participants were admitted into the study based on being colonized with SA. Participants who were decolonized both on day 8 and day 22, as determined by NUP cultures were considered to have persistent decolonization. Colonization was defined as the presence of SA identified by NUP culture without signs of illness or infection. NUP swabs were collected on day 8 and on day 22 and cultured by direct plating. If the cultures were negative for SA at both day 8 and day 22 the participant was considered to have persistent decolonization. Colonization with SA was a prerequisite for enrollment, because of this there was no baseline measure.|Day 8 and Day 22|The analysis population included all infants with a site-specific pre-randomization NUP culture that was positive for SA by direct culture and who had either had complete sets of NUP cultures collected on day 8 and day 22 or else had discontinued NUP cultures prior to day 22 due to a clinical SA infection.||Participants|||Count of Participants
662328|NCT01824446|Primary|Maximum Plasma Concentration (Cmax) of Radiolabelled SSP-004184|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Up to 288 hours post-dose|PAS||ng/ml||Standard Deviation|Mean
662214|NCT01827358|Primary|Primary Decolonization Efficacy- Number of Participants in the Treatment and Control Groups Who Have no Detectable S. Aureus (SA) on Direct Nasal, Umbilical, and Perianal (NUP) Cultures Obtained on Day 8.|Colonization was defined as the presence of SA identified by NUP culture without signs of illness or infection. On day 8, participants were swabbed in each of three areas: nasal, umbilical, and perianal. These swabs were cultured by direct plating. If SA did not grow on any of these cultures the infant was considered to be decolonized. If SA grew on any one of these cultures the infant was considered to be colonized with SA.|Day 8|The analysis population included all infants with a site-specific pre-randomization NUP culture that was positive for SA by direct culture and who either had a complete set of NUP cultures collected on Day 8 or else had discontinued NUP cultures prior to day 8 due to a clinical SA infection.||Participants|||Count of Participants
662215|NCT01827358|Primary|Number of Participants With Serious Adverse Events (SAEs) During Days 1-7|Participants were evaluated for Serious Adverse Events (SAEs) while in the NICU/ICU on days 1-7. Although participants received only 5 days of mupirocin, SAEs were collected through day 7. An adverse event or suspected adverse reaction was considered serious if, in the view of either the investigator or sponsor, it resulted in any of the following outcomes: death; a life-threatening adverse event (an event that places the participant at immediate risk of death; it doesn't include an adverse event, had it occurred in a more severe form, might have caused death); inpatient hospitalization or prolongation of existing hospitalization; a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; or any other event that when based upon appropriate medical judgement may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed in this definition.|Days 1 through 7|The analysis population was comprised of all infants, categorized according to treatment group. The number of infants is different from the overall study participant counts as 2 participants randomized to the mupirocin group received no mupirocin. For the purpose of safety analysis, these were included in the control (no mupirocin) group.||Participants|||Count of Participants
662216|NCT01827358|Primary|Number of Participants With Moderate and Severe Unsolicited Adverse Events; During Days 1-7|Participants were evaluated for moderate and severe unsolicited adverse events (that were not otherwise considered pre-defined trial endpoints) while in the NICU/ICU on days 1-7. Although participants received 5 days of mupirocin, unsolicited events were collected until day 7. Moderate events were defined as those that may cause some interference with functioning and daily activities. Severe events were defined as those that interrupt the participant's usual daily activities and may require systemic drug therapy or other treatment. Severe events were usually incapacitating.|Days 1 through 7|The analysis population was comprised of all infants, categorized according to treatment group. The number of infants is different from the overall study participant counts as 2 participants randomized to the mupirocin group received no mupirocin. For the purpose of safety analysis, these were included in the control (no mupirocin) group.||participants||95% Confidence Interval|Number
662217|NCT01827358|Primary|Number of Participants With Solicited Adverse Events (AEs) During Days 1-7|Participants were evaluated for solicited adverse events while in the NICU/ICU on days 1-7. Participants were counted if they experienced the symptom at any severity during the reporting period. Although participants received only 5 days of mupirocin, solicited events were collected through day 7.|Days 1 through 7|The analysis population was comprised of all infants, categorized according to treatment group. The number of infants is different from the overall study participant counts as 2 participants randomized to the mupirocin group received no mupirocin. For the purpose of safety analysis, these were included in the control (no mupirocin) group.||participants|||Number
662218|NCT01827332|Secondary|Marijuana Use (as Measured by Subjective Report of Number of Daily Smoking Sessions )|Subjects' marijuana use was measured via self-report of number of smoking sessions per day (Time Line Followback). The average number of daily sessions were calculated per group, with data presented below representing the change in amount of daily smoking sessions per group from first MET session to last MET session.|Self-report of average daily smoking sessions at MET Session 1 and last MET session 3|||daily smoking sessions||Standard Error|Mean
662219|NCT01827332|Primary|Therapy Session Satisfaction (as Measured by Subjective Report)|After MET sessions, subjects completed the Session Rating Scale (SRS, Miller et al). This visual analog scale is comprised of 4 items for which participants rate their therapy experience in terms of relationship, goals and topics, approach/method, and overall, with minimum score 0 representing most dissatisfied and maximum score 10 representing most satisfied. Outcome measure reported below represents SRS score at last MET session.|Within 5 minutes of completing a 45-60 minute Motivational Enhancement Therapy (MET) session at last session visit|||units on a scale||Standard Error|Mean
662220|NCT01827319|Secondary|2 CCS Angina Class Reduction|Canadian Cardiovascular Society (CCS) Angina Class-Class I: Ordinary physical activity does not cause angina, such as walking and climbing stairs. Angina with strenuous or rapid or prolonged exertion at work or recreation; Class II: Slight limitation of ordinary activity. Walking or climbing stairs rapidly, walking uphill, walking or stair climbing after meals, or in cold, or in wind, or under emotional stress, or only during the few hours after awakening. Walking more than two blocks on the level and climbing more than one flight of ordinary stairs at a normal pace and in normal conditions; Class III: Marked limitation of ordinary physical activity. Walking one or two blocks on the level and climbing one flight of stairs in normal conditions and at normal pace; Class IV: Inability to carry on any physical activity without discomfort, anginal syndrome may be present at rest.|30 days|||participants|||Number
662221|NCT01827319|Secondary|Major Adverse Cardiovascular Events (MACE) Rate, Defined as the Incidence of Cardiac-related Death, Myocardial Infarction (Q-wave and Non Q-wave), Congestive Heart Failure, Cerebrovascular Accident, and Serious Arrhythmia||30 days|||participants|||Number
662222|NCT01827319|Primary|All Cause Mortality|Number of Participant Deaths|30 days|||participants|||Number
662223|NCT01827306|Primary|Change From Baseline of Numeric Pain Rating Scale (NPRS)at 4 Weeks|The Numeric Pain Rating Scale (NPRS) is a self-report scale measuring pain. It is measured from 0 to 10, 0 being pain free and 10 being the worse imaginable pain.|4 weeks|||units on a scale, from 0 to 10||Full Range|Mean
662224|NCT01827306|Primary|Change From Baseline of American Shoulder and Elbow Surgeons (ASES) Questionnaire at 4 Weeks|The American Shoulder and Elbow Surgeons (ASES) Questionnaire is a self-report questionnaire measuring pain and disability. It is measured from 0 to 100, 0 being completely disabled and 100 being pain free and normal function. The total score is calculated using the following equation: (10-NPRS) x 5 = __ + (5/3) x Cumulative ADL Score|4 weeks|||units on a scale||Full Range|Mean
662225|NCT01827306|Primary|Change From Baseline of Numeric Pain Rating Scale (NPRS) at 2 Weeks|The Numeric Pain Rating Scale (NPRS) is a self-report scale measuring pain. It is measured from 0 to 10, 0 being pain free and 10 being the worse imaginable pain.|2 weeks|||units on a scale||Full Range|Mean
662226|NCT01827306|Primary|Change From Baseline of American Shoulder and Elbow Surgeons (ASES) Questionnaire at 2 Weeks|The American Shoulder and Elbow Surgeons (ASES) Questionnaire is a self-report questionnaire measuring pain and disability. It is measured from 0 to 100, 0 being completely disabled and 100 being pain free and normal function. The total score is calculated using the following equation: (10-NPRS) x 5 = __ + (5/3) x Cumulative ADL Score|2 weeks|||units on a scale||Full Range|Mean
662227|NCT01827267|Secondary|Overall Survival (OS)|Defined as the time (month) from randomization to death due to any cause; censored at the date last known alive.|From randomization to death or end of long term follow-up|All subjects who received at least 1 dose of drug||months||95% Confidence Interval|Median
662228|NCT01827267|Secondary|Progression Free Survival (PFS)|Defined as time from date of randomization until the first disease recurrence or progression per RECIST V1.1 or death due to any cause; censored at the last assessable evaluation or at the initiation of new anti-cancer therapy. Disease assessment is based on investigator tumor assessments. If no post-baseline tumor assessment then censored at enrollment date.|From randomization to disease progression or last tumor assessment|All subjects who received at least 1 dose of drug||months||95% Confidence Interval|Median
662229|NCT01827267|Secondary|Duration of Response (DOR)|Measured from the time at which measurement criteria were first met for CR or PR (whichever status was recorded first), until the date of first recurrence, PD, or death was objectively documented, taking as a reference for PD the smallest measurements recorded since enrollment, per RECIST (v1.1) criteria.|From first response to first PD or death|All subjects who received at least 1 dose of drug and had either complete or partial response.||Participants|||Count of Participants
662230|NCT01827267|Secondary|Clinical Benefit Rate (CBR)|CBR is defined as the proportion of patients who achieved objective response (CR or PR) or SD for at least 12 weeks.|From randomization to disease progression or death|All subjects who received at least one dose.||percentage of overall population||95% Confidence Interval|Number
662231|NCT01827267|Primary|Objective Response Rate (ORR)|ORR is defined as proportion of subjects who achieved confirmed complete response (CR) or partial response (PR) per RECIST v1.1. A complete or partial response must be confirmed no less than 4-weeks after the criteria for response are initially met.|From randomization to disease progression or last tumor assessment|All subjects who received at least 1 dose of drug||percentage of overall population||95% Confidence Interval|Number
662232|NCT01827254|Primary|Progression Free Survival: Third Line Treatment|The PFS was defined as the time interval between the start date of treatment and the date of progression as assessed by the investigator or date of death occurring after treatment initiation, whichever occurred first. Duration of progression free survival= [(Date of mRCC progression – Start date of the treatment) + 1)]/ 365.25 x 12. Progression was defined as an increase in visible disease. Third-line treatment were divided in two groups: Group A (received treatment with: bevacizumab (with interferon), bevacizumab (without interferon), sorafenib, axitinib) and Group B (received treatment with: temsirolimus, everolimus).|From start of treatment up to 23.7 months|"Evaluable population: All participants included in the analysis. Here “N” signifies number of participants who were analyzed for this outcome measure and n signifies those participants who were evaluable for respective treatment group."||months||95% Confidence Interval|Median
662233|NCT01827254|Primary|Progression Free Survival: Second Line of Treatment|The PFS was defined as the time interval between the start date of treatment and the date of progression as assessed by the investigator or date of death occurring after treatment initiation, whichever occurred first. Duration of progression free survival= [(Date of mRCC progression – Start date of the treatment) + 1)]/ 365.25 x 12. Progression was defined as an increase in visible disease. Second-line treatment were divided in two groups: Group A (received treatment with: bevacizumab (with interferon), bevacizumab (without interferon), sorafenib, axitinib) and Group B (received treatment with: temsirolimus, everolimus).|From start of treatment up to 22.9 months|"Evaluable population: All participants included in the analysis. Here “N” signifies number of participants who were analyzed for this outcome measure and n signifies those participants who were evaluable for respective treatment group."||months||95% Confidence Interval|Median
662234|NCT01827254|Primary|Progression Free Survival for Re-challenge With Sunitinib|The PFS was defined as the time interval between the start date of treatment and the date of progression as assessed by the investigator or date of death occurring after treatment initiation, whichever occurred first. Duration of progression free survival= [(Date of mRCC progression – Start date of the treatment) + 1)]/ 365.25 x 12. Progression was defined as an increase in visible disease.|From start of treatment up to 52.2 months|Evaluable population: All participants included in the analysis. Here “N” signifies number of participants who were analyzed for this outcome measure.||months||95% Confidence Interval|Median
662235|NCT01827254|Other Pre-specified|Number of Participant With Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs include both serious as well as non-serious AEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to 24 months|Evaluable population: All participants included in the analysis.||participants|||Number
662236|NCT01827254|Secondary|Percentage of Participants With Objective Response|Percentage of participants with objective response based assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as complete disappearance of all target lesions and non-target lesions, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. Percentage of participants with objective response was calculated for the 1st-line of therapy with Sunitinib, Sunitinib re-challenge and for retreatment with Sunitinib as 3rd-line of therapy or more.|Baseline up to 98.0 months|Evaluable population: All participants included in the analysis.||percentage of participants||95% Confidence Interval|Number
662237|NCT01827254|Secondary|Overall Survival|Overall survival of patients under treatment was evaluated by calculating the time between date of initiation of treatment (1st line) and date of death, if the latter occurred before the end of the study. Duration of Overall Survival =(Date of death – Start date of treatment) + 1)/365.25 x 12.|Baseline up to death or end of study (up to 98.0 months)|Evaluable population: All participants included in the analysis.||months||95% Confidence Interval|Median
662238|NCT01827254|Primary|Progression Free Survival With Sunitinib as First Line of Therapy|The PFS was defined as the time interval between the start date of treatment and the date of progression as assessed by the investigator or date of death occurring after treatment initiation, whichever occurred first. Duration of progression free survival= [(Date of mRCC progression – Start date of the treatment) + 1)]/ 365.25 x 12. Progression was defined as an increase in visible disease.|From start of treatment up to 66.6 months|Evaluable population: All participants included in the analysis.||months||95% Confidence Interval|Median
662239|NCT01826981|Secondary|Percentage of Participants Experiencing Viral Relapse|Viral relapse is defined as HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement.|Up to Posttreatment Week 24|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants|||Number
662240|NCT01826981|Secondary|Percentage of Participants With On-treatment Virologic Failure|"On-treatment virologic failure was defined as:
Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)"|Up to Posttreatment Week 24|Full Analysis Set||percentage of participants|||Number
662241|NCT01826981|Secondary|For Cohort 6, Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 16 and 20 Weeks After Discontinuation of Therapy (SVR16 and SVR 20)||Posttreatment Weeks 16 and 20|Full Analysis Set included the participants who were randomized into Cohort 6 and received at least one dose of study drug.||percentage of participants|||Number
662242|NCT01826981|Secondary|Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)||Posttreatment Weeks 2, 4, 8, and 24|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants|||Number
662243|NCT01826981|Secondary|Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment||Weeks 16, 20, and 24|Full Analysis Set||percentage of participants|||Number
662244|NCT01826981|Secondary|Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment||Week 12|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants|||Number
662245|NCT01826981|Secondary|Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment||Week 10|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants|||Number
662246|NCT01826981|Secondary|Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment||Weeks 4, 6, and 8|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants|||Number
662247|NCT01826981|Secondary|Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment||Weeks 1 and 2|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants|||Number
662248|NCT01826981|Primary|Percentage of Participants With Adverse Events Leading to Permanent Discontinuation of Study Drug(s)||Up to 24 weeks plus 30 days|Safety Analysis Set||Percentage of participants|||Number
662249|NCT01826981|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 is defined as HCV RNA < lower limit of quantification (LLOQ) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full analysis set: Participants who were randomized and received at least 1 dose of study drug.||percentage of participants|||Number
662250|NCT01826812|Secondary|Cytokines|Identification of various inflammatory cytokines in tear film of dry eye patients comparing to controls and the effect of sustained reading to the levels of these cytokines.|30 minutes||06/2017||||
662251|NCT01826812|Secondary|Change in Visual Acuity||30 minutes|||logMAR||Standard Deviation|Mean
662252|NCT01826812|Secondary|Change in Tear Osmolarity||Before and after 30 minutes reading|||mOsm/L||Standard Deviation|Mean
662253|NCT01826812|Secondary|Change in Total Ocular Staining Score (OSS)|Ocular staining score (OSS) is sum of the corneal and conjuctival staining scores with a total possible maximum score of 12 for each eye. Corneal staining is graded with a maximum possible fluorescein score of 6 for each cornea (the punctate epithelial erosions grade between 0-3 plus any extra points for modifiers up to 3). Nasal and temporal conjunctiva are graded separately with a score range between 0 and 3 for each area after instillation of lissamine green. An abnormal OSS is defined as being a total score of 3 or more.|Before and after 30 minutes reading|||units on a scale||Standard Deviation|Mean
662254|NCT01826812|Primary|Sustained Silent Reading Speed||30 minutes|||words/minute||Standard Deviation|Mean
662255|NCT01826604|Secondary|Secondary Outcomes Will Include the Differences Between the Two Groups.|Secondary outcomes will include the duration of surgery or length of time from skin incision to delivery of the infant, change in hemoglobin, estimated blood loss, and postoperative length of stay, intra-operative or postoperative anti-emetic requirements, need for hospital readmission or emergency room visits, or other complication rates between the two groups.|From the time of surgery to 30 days post-op.|infection during 30 day postoperative period||participants|||Number
662256|NCT01826604|Primary|Wound Infection or Disruption|We will compare the number of patients with wound infections or disruptions when the Alexis O C-Section retractor is used vs when it is not used.|Time of surgery to 30 days post op|Any SSI or wound disruption during 30 day postoperative period||participants|||Number
662257|NCT01826513|Secondary|Number of Respiratory Event Related Arousals|Total number of respiratory event related arousals over the entire sleep period|1 day|Reported results only include data from the blinded cross-over sequence arms (ie. Standard and Modified AutoSet algorithms). Data from the Unblinded Investigational phase of the trial was excluded as this phase was exploratory only to help refine the algorithm, and so, was not intended to be included in the final dataset.||Respiratory-Event Related Arousals||Standard Deviation|Mean
662258|NCT01826513|Secondary|Percentage of Total Sleep Time Spent in Each Sleep Stage|Percentage of total sleep time spent in each sleep stage (ie. N1, N2, N3 and REM)|1 day|Reported results only include data from the blinded cross-over sequence arms (ie. Standard and Modified AutoSet algorithms). Data from the Unblinded Investigational phase of the trial was excluded as this phase was exploratory only to help refine the algorithm, and so, was not intended to be included in the final dataset.||percentage of total sleep time||Standard Deviation|Mean
662259|NCT01826513|Secondary|Oxygen Saturation|Oxygen saturation recorded in the total sleep time|1 day|Reported results only include data from the blinded cross-over sequence arms (ie. Standard and Modified AutoSet algorithms). Data from the Unblinded Investigational phase of the trial was excluded as this phase was exploratory only to help refine the algorithm, and so, was not intended to be included in the final dataset.||percentage SpO2||Standard Deviation|Mean
662260|NCT01826513|Secondary|Number of Central Apnoeas|Total number of central apnoeas occurring in the total sleep time|1 day|Reported results only include data from the blinded cross-over sequence arms (ie. Standard and Modified AutoSet algorithms). Data from the Unblinded Investigational phase of the trial was excluded as this phase was exploratory only to help refine the algorithm, and so, was not intended to be included in the final dataset.||Central Apnoeas||Standard Deviation|Mean
662261|NCT01826513|Secondary|Number of Obstructive Apnoeas|Total number of obstructive apnoeas occurring in the total sleep time|1 day|Reported results only include data from the blinded cross-over sequence arms (ie. Standard and Modified AutoSet algorithms). Data from the Unblinded Investigational phase of the trial was excluded as this phase was exploratory only to help refine the algorithm, and so, was not intended to be included in the final dataset.||Obstructive Apnoeas||Standard Deviation|Mean
662262|NCT01826513|Secondary|Number of Hypopnoeas|Total number of hypopnoeas occurring in the total sleep time|1 day|Reported results only include data from the blinded cross-over sequence arms (ie. Standard and Modified AutoSet algorithms). Data from the Unblinded Investigational phase of the trial was excluded as this phase was exploratory only to help refine the algorithm, and so, was not intended to be included in the final dataset.||Hypopneas||Standard Deviation|Mean
662263|NCT01826513|Secondary|Number of Spontaneous Arousals|Number of spontaneous arousals occurring over the entire total sleep time|1 day|Reported results only include data from the blinded cross-over sequence arms (ie. Standard and Modified AutoSet algorithms). Data from the Unblinded Investigational phase of the trial was excluded as this phase was exploratory only to help refine the algorithm, and so, was not intended to be included in the final dataset.||Spontaneous Arousals||Standard Deviation|Mean
662264|NCT01826513|Secondary|Time Taken to Fall Asleep|Time in minutes taken to fall alseep|1 day|Reported results only include data from the blinded cross-over sequence arms (ie. Standard and Modified AutoSet algorithms). Data from the Unblinded Investigational phase of the trial was excluded as this phase was exploratory only to help refine the algorithm, and so, was not intended to be included in the final dataset.||minutes||Standard Deviation|Mean
662265|NCT01826513|Secondary|Wake After Sleep Onset Time|Time awake in minutes after initial sleep onset|1 day|Reported results only include data from the blinded cross-over sequence arms (ie. Standard and Modified AutoSet algorithms). Data from the Unblinded Investigational phase of the trial was excluded as this phase was exploratory only to help refine the algorithm, and so, was not intended to be included in the final dataset.||minutes||Standard Deviation|Mean
662266|NCT01826513|Secondary|Sleep Efficacy|Sleep time divided by total time available for sleep|1 day|Reported results only include data from the blinded cross-over sequence arms (ie. Standard and Modified AutoSet algorithms). Data from the Unblinded Investigational phase of the trial was excluded as this phase was exploratory only to help refine the algorithm, and so, was not intended to be included in the final dataset.||percentage of total recorded time||Standard Deviation|Mean
662267|NCT01826513|Primary|Oxygen Desaturation Index (ODI)|Number of oxygen desaturations per hour of sleep|1 day|Reported results only include data from the blinded cross-over sequence arms (ie. Standard and Modified AutoSet algorithms). Data from the Unblinded Investigational phase of the trial was excluded as this phase was exploratory only to help refine the algorithm, and so, was not intended to be included in the final dataset.||events/hour||Standard Deviation|Mean
662268|NCT01826513|Primary|Apnoea Hypopnoea Index (AHI)|Number of apnoeas and hypopnoeas per hour of sleep|1 day|Reported results only include data from the blinded cross-over sequence arms (ie. Standard and Modified AutoSet algorithms). Data from the Unblinded Investigational phase of the trial was excluded as this phase was exploratory only to help refine the algorithm, and so, was not intended to be included in the final dataset.||events/hour||Standard Deviation|Mean
662269|NCT01826214|Secondary|Parmacokintics (PK) Parameter: AUC0-24h|AUC0-24 is the area under the concentration-time curve from time zero to 24 hours done only on 800 mg once a day schedule. The PK parameters were determined in plasma using non-compartmental methods. A PK sample was excluded from analyses if the patient vomited within the first 4 hours following the last oral dose of study drug. Other PK samples were excluded as deemed appropriate by the Pharmacokineticist. AUC0-24h was derived from the PK concentrations collected at 0, 0.5, 1, 2, 4, 6, 8 and 24 hours post dose on W1D1 and W9D1. The PK concentration at each time point is not an endpoint in the protocol, but these concentrations are used to derive the PK parameters.|Week 1 Day 1,Week 9 Day 1|Pharmacokinetic analysis set (PAS): consisted of all patients who received at least one dose of sonidegib and provided at least one evaluable PK blood sample.||ng*hr/mL||Standard Deviation|Mean
662270|NCT01826214|Secondary|Parmacokintics (PK) Parameter: AUC0-8h|AUC0-8h is the area under the concentration-time curve from time zero to 8 hours. The PK parameters were determined in plasma using non-compartmental methods. A PK sample was excluded from analyses if the patient vomited within the first 4 hours following the last oral dose of study drug. Other PK samples were excluded as deemed appropriate by the Pharmacokineticist. AUC0-8h was derived from the PK concentrations collected at 0, 0.5, 1, 2, 4, 6, 8 and 24 hours post dose on W1D1 and W9D1. The PK concentration at each time point is not an endpoint in the protocol, but these concentrations are used to derive the PK parameters.|Week 1 Day 1,Week 9 Day 1|Pharmacokinetic analysis set (PAS): consisted of all patients who received at least one dose of sonidegib and provided at least one evaluable PK blood sample.||ng*hr/mL||Standard Deviation|Mean
662478|NCT01821417|Secondary|Millimeters of Periodontal Pocket Depth Surrounding the Dental Implant Device|Probing pocket depth (PD) is measured from the mucosal sulcus to the depth of the pocket attachment after implant restoration.|1 year after placement|No data was collected. Previously entered data was entered incorrectly.|||||
662271|NCT01826214|Secondary|Parmacokintics (PK) Parameter: Tmax|Tmax is the time to reach Cmax. The PK parameters were determined in plasma using non-compartmental methods. A PK sample was excluded from analyses if the patient vomited within the first 4 hours following the last oral dose of study drug. Other PK samples were excluded as deemed appropriate by the Pharmacokineticist. Tmax was derived from the PK concentrations collected at 0, 0.5, 1, 2, 4, 6, 8 and 24 hours post dose on W1D1 and W9D1. The PK concentration at each time point is not an endpoint in the protocol, but these concentrations are used to derive the PK parameters.|Week 1 Day 1,Week 9 Day 1|Pharmacokinetic analysis set (PAS): consisted of all patients who received at least one dose of sonidegib and provided at least one evaluable PK blood sample.||hr||Inter-Quartile Range|Median
662272|NCT01826214|Secondary|Parmacokintics (PK) Parameter: Cmax|Cmax is the maximum observed plasma concentration after drug administration.The PK parameters were determined in plasma using non-compartmental methods. A PK sample was excluded from analyses if the patient vomited within the first 4 hours following the last oral dose of study drug. Other PK samples were excluded as deemed appropriate by the pharmacokineticist. Cmax was derived from the PK concentrations collected at 0, 0.5, 1, 2, 4, 6, 8 and 24 hours post dose on W1D1 and W9D1. The PK concentration at each time point is not an endpoint in the protocol, but these concentrations are used to derive the PK parameters.|Week 1 Day 1, Week 9 Day 1|Pharmacokinetic analysis set (PAS): consisted of all patients who received at least one dose of sonidegib and provided at least one evaluable PK blood sample.||ng/mL||Standard Deviation|Mean
662273|NCT01826214|Secondary|Overall Response Rate (ORR)|ORR was the rate of complete remission (CR), complete remission with incomplete blood count recovery (CRi) or partial response (PR) according to IWG criteria. CR, CRi or PR will be assessed through bone marrow biopsy/aspirate and peripheral blood blasts counts.|Every 8 weeks for the first 6 months and every 12 weeks until 53 weeks after the last patient is enrolled or until relapse up to 24 months|"Full analysis set (FAS): comprised of all patients who were randomized to a study treatment.
According to the intent-to-treat principle, patient data were analyzed according to the treatment to which they had been randomized."||Participants|||Number
662274|NCT01826214|Primary|Complete Remission With Incomplete Blood Count Recovery (CRi)|The other primary efficacy endpoint was CRi based on the International Working Group (IWG) criteria based on weekly peripheral blood count measurements and bone marrow biopsy/aspiration collection. Efficacy assessments were performed to determine CRi. A treatment cycle was defined as 4 weeks. No statistical analysis was planned for this primary outcome.|within 3 days after clearance of blasts from peripheral blood (PB), monthly thereafter until CR or reappearance of blasts in the PB, after CR every other month until discontination up to 24 months|"Full analysis set (FAS): comprised of all patients who were randomized to a study treatment.
According to the intent-to-treat principle, patient data were analyzed according to the treatment to which they had been randomized."||Participants|||Number
662275|NCT01826214|Primary|Rate of Complete Remission (CR)|Complete Response (CR) was based on the International Working Group (IWG) criteria based on weekly peripheral blood count measurements and bone marrow biopsy/aspiration collection. Efficacy assessments were performed to determine CR. A treatment cycle was defined as 4 weeks. The outcome measure for the study is based on standardized response criteria as defined by the International Working Group (IWG) for AML. The IWG was established by a group of investigators interested in the design and conduct of clinical trials in acute myeloid leukemia (AML). The criteria established by this group (a set of recommendations for response assessment) are well established, endorsed by major institutions and Health Authorities, and are widely used in clinical trials. No statistical analysis was planned for this primary outcome.|at screening, every week up to Week 9, every 2 weeks thereafter until CR, every 4 weeks after CR up to 24 months|"Full analysis set (FAS): comprised of all patients who were randomized to a study treatment.
According to the intent-to-treat principle, patient data were analyzed according to the treatment to which they had been randomized. No statistical analysis were reported in this study."||Participants|||Number
662276|NCT01826201|Secondary|Safety Assessment|Safety will be assessed based on reported adverse events, physical examination, vital signs, electrocardiograms, hematology, serum chemistry and urinalysis. Adverse events will be reported throughout the trial. Vital signs will be performed at screening, baseline, prior to the morning dose on Days 0, 1, 7, 14, 28, and at the follow up visit on Day 42. Physical examinations will be performed at Screening, baseline and Day 28. Hematology, serum chemistry and urinalysis will be performed at screening, baseline, Days 1, 7, 14, 28, and at the follow up visit on Day 42. ECGs will be performed at Screening, baseline and Day 28.|Baseline and Day 28||||||
662277|NCT01826201|Secondary|Change in EIS Area|Change in Erythema, Induration and Scale (EIS) area. Total score will be the EIS x Area, and will be calculated at baseline, Day 7, Day 14 and Day 28. The EIS will represent the sum of individual scores of Erythema, Induration and Scale using the same scale utilized in the PSS. The area of active erythema, induration and scale will be measured and the total scores will be calculated from the EIS scores multiplied by the area in cm2.|Baseline and Day 28||||||
662278|NCT01826201|Secondary|Treatment Success|Percent of patients achieving treatment success in the treatment group compared to the placebo group on day 28. Treatment success is defined as patient achieving a psoriasis severity score (PSS) of 3 or less, or an improvement of 5 points or more on the PSS.|Baseline and Day 28||||||
662279|NCT01826201|Secondary|Physician's Treatment Preference|The physician's treatment preference utilizing visual assessment and selection of the most improved plaque. The determination will be either 1)right lesion is preferred compared to left, 2)left lesion is preferred compared to right, 3) no difference between the right and left lesion.|Day 7, Day 14, Day 28|Per protocol||participants|Participants||Number
662280|NCT01826201|Secondary|Improvement in Lesion Appearance|Photography of the MOL4239 and placebo treated lesions will be performed at baseline, Day 7, Day 14 and Day 28 to assess for the improvement in lesion appearance after drug treatment. The assessment will be completed by a blinded panel of dermatologists experienced in the assessment of psoriasis.|Baseline and Day 28||||||
662292|NCT01824901|Primary|Maximum Tolerated Dose (MTD) of FGFR Inhibitor AZD4547|A total of 3 dose levels of AZD4547 were planned: 40mg (level 1), 60mg (level 2), and 80mg (level 3) in combination with a standard dose of docetaxel (75mg/m^2). The starting dose level of AZD4547 was 40 mg. This portion of the study used a standard 3+3 design with patients enrolled in cohorts of 3. The plan was to recommend the maximum tolerated dose (MTD) as the dose level to be used in the phase II portion of the study. MTD is defined as the highest dose level at which less than or equal to 1 of 6 subjects experience dose limiting toxicity (DLT).|Assessed during cycle 1 (21 days)|||mg|||Number
662281|NCT01826201|Primary|Mean Change From Baseline to Day 28 in PSS (Psoriasis Severity Score) of the Treatment Target Lesions Compared to Placebo Target Lesions|"he study drug application sites were scored for erythema, induration, and scale assessment using the PSS Scoring system. Psoriasis Severity Score (PSS) Erythema 0 - 4, 0 None, may have residual non-erythematous discoloration
1 Faint erythema 2 Moderate erythema/red color 3 Severe erythema/very red discoloration 4 Very severe erythema/extreme red coloration Induration 0 - 4 0 None
Trace or slight elevation of plaque above normal skin level
Moderate elevation with rounded or sloped edges to plaque
Marked elevation with hard, sharp edges to plaque
Very marked elevation with very hard, sharp edges to plaque Scaling 0 - 4
0 None
Fine scales
Coarse scales
Thick scales with a rough surface
Thick scales with a very rough surface
The scores were summed"|Baseline and Day 28|||PSS score|Participants|Standard Deviation|Mean
662282|NCT01825837|Primary|Proportion of Patients Who Showed no Worsening According to the Clinical Global Impression - Bipolar Version (CGI-BP) Scale (Intent-to-Treat Population)|The CGI-BP scale is a modification of the CGI scale, which provides a means of assessing severity and treatment-related improvement in manic and depressive domains reflecting clinically relevant degrees of change. The concept of improvement refers to the clinical distance between the individual’s current condition and that prior to the start of treatment. The scale for ‘severity of illness’ measures mania, depression and overall illness on a 7 point scale from 1 (‘normal, not ill’) to 7 (‘very severely ill’). The scale for ‘change from preceding phase’ and ‘change from worst phase’ measures mania, depression, and overall illness on an 8-point scale from 1 (very much improved) to 8 (‘not applicable’). If the patient, in ‘change from preceding phase’, at any visit during the double-blind, has a score of 5, 6, or 7 in any of 3 categories (mania, depression, or overall bipolar illness), then the illness will be considered to have worsened.|6 months|||participants|||Number
662283|NCT01825577|Secondary|POMA -Performance Oriented Mobility Assessment - Measure of Gait and Balance.|Performance Oriented Mobility Assessment (POMA), used to measure subject's ability to maintain balance. The test takes 10-15 minutes and involves asking subject to stand from a sitting position, standing with eyes closed and sitting down. POMA total score has a range of 0-36 where higher scores represent better performance. POMA total score is an additive combination of the 12 point Gait sub-score and the 16 point balance sub-score. A cut-off score of <21 is generally considered a fall risk among elderly people.|4 weeks|Elderly patients living in community nursing homes identified as fall risk with a diagnosis of probable Alzheimer's Disease.||Units on a scale||Standard Deviation|Mean
662284|NCT01825577|Primary|Timed Get Up and Go Test - Measure of Mobility|Timed Get Up and Go Test (TUG), is used to evaluate the ability to walk by measuring the time it takes to rise from a chair, walk 10 feet, turn around, walk back to the chair, and sit down. The TUG test takes less than 5 minutes to complete. Scored as seconds required to complete the task.|Baseline and Post-test at 4 weeks|Elderly patients living in community nursing homes identified as fall risks with a diagnosis of probable Alzheimer's disease.||seconds||Standard Deviation|Mean
662285|NCT01825408|Primary|Number of Patients Recommended for Sinus Surgery After 6 Weeks of Antibiotic Therapy|Recommendation for sinus surgery after completion of maximal medical therapy is determined by the subject's treating physician and is based on two citeria: (1) persistence of symptoms and (2) objective evidence of disease on post-treatment sinus CT scan or nasal endoscopy. Symptomatic improvement of sinusitis symptoms will be assessed by: patient self report, change in Chronic Sinusitis Survery (CSS) score and change in RhinoSinusitis Disibility Index (RSDI) score relative to initial pre-antibiotic CSS and RSDI survey scores.|7-8 weeks after initiating antibiotics|||Participants|||Count of Participants
662286|NCT01825408|Primary|Number of Patients Recommended for Sinus Surgery After 3 Weeks of Antibiotic Therapy|Recommendation for sinus surgery after completion of maximal medical therapy is determined by the subject's treating physician and is based on two citeria: (1) persistence of symptoms and (2) objective evidence of disease on post-treatment sinus CT scan or nasal endoscopy. Symptomatic improvement of sinusitis symptoms will be assessed by: patient self report, change in Chronic Sinusitis Survery (CSS) score and change in RhinoSinusitis Disibility Index (RSDI) score relative to initial pre-antibiotic CSS and RSDI survey scores.|4-5 weeks after starting antibiotics|||Participants|||Count of Participants
662287|NCT01825200|Secondary|Subjects With at Least One Hypersensitivity Event Reported on Day 0 and Days 0-7 Following Vaccine Administration as a Measure of Safety|Subjects with at least one pre-defined common systemic hypersensitivity adverse event, including rash, urticaria, swelling or non-dependent edema on Day 0 and for Days 0 to 7 following vaccine administration|7 Days|The primary analysis population, includes all randomized subjects who received a dose of study vaccine and for whom some safety data were available after administration of vaccine. Subjects were analyzed according to the vaccine received, regardless of whether this was the treatment group to which they were randomized.||participants|||Number
662288|NCT01825200|Secondary|Number of Participants With Local and Systemic Events Reported as a Measure of Safety|Number of solicited local and systemic events of reactogenicity reported with the help of a memory aid during the seven days following vaccine administration.|7 Days|The primary analysis population, includes all randomized subjects who received a dose of study vaccine and for whom some safety data were available after administration of vaccine. Subjects were analyzed according to the vaccine received, regardless of whether this was the treatment group to which they were randomized.||participants|||Number
662289|NCT01825200|Secondary|Subjects With at Least One Unsolicited Adverse Event in the 30 Days Following Vaccine Administration|Subjects with at least one serious adverse event and subjects with at least one medically-attended unsolicited adverse event occurring during the 30 days following vaccine administration|30 Days|The primary analysis population, includes all randomized subjects who received a dose of study vaccine and for whom some safety data were available after administration of vaccine. Subjects were analyzed according to the vaccine received, regardless of whether this was the treatment group to which they were randomized.||participants|||Number
662290|NCT01825200|Primary|Number of Participants With Common Hypersensitivity Reactions as Measure of Safety|Number of participants who experience a pre-defined common systemic hypersensitivity adverse event, including rash, urticaria, swelling or edema through Day 30 post-vaccine administration.|30 Days|The primary analysis population, includes all randomized subjects who received a dose of study vaccine and for whom some safety data were available after administration of vaccine. Subjects were analyzed according to the vaccine received, regardless of whether this was the treatment group to which they were randomized.||participants|||Number
662293|NCT01824823|Primary|Disease-free Survival (DFS)|DFS is defined as the time from randomization to the earlier of disease recurrence, second primary cancer, or death without recurrence.|Assessed every 3 months for patients < 2 years from registration and every 6 months if patient is 2-3 years from registration and every 12 months if patient is 4-5 years from registration|All randomized patients||months||95% Confidence Interval|Median
662294|NCT01824602|Primary|Change in Young Mania Rating Scale (YMRS) Total Score From Baseline Until the End of the 3-week Treatment Period|The YMRS is used to assess disease severity in patients who have been previously diagnosed with mania and it has proven psychometric properties through 11 item multiple-choice diagnostic questionnaire and the total score is determined from the summation of each 11 individual scores (and can range from 0 – 60) based on the patient’s subjective feedback of his clinical condition over the previous 48 hours. A higher score indicates a worse rating for symptoms related to mania. At every visit throughout the study, investigators administered the YMRS. The results of the primary analysis of efficacy were calculated using Analysis of covariance (ANCOVA) with Last Observation Carried Forward (LOCF). Primary variable is presented through ANCOVA results for absolute change in YMRS total score from baseline (V2) to end of treatment (V7). A responder has at least 50% improvement (reduction) in the YMRS total score or has a total score of less than 12 points at the end of treatment period.|baseline and 3-week|The ITT efficacy population of 37 patients consisted of all randomised patients who received at least one dose of investigational product and at least 1 post-baseline YMRS assessment. If a patient discontinues before the end of the 3-week treatment period then the last observation will be carried forward (LOCF).||units on a scale||Standard Error|Mean
662295|NCT01824589|Secondary|Arterial Blood Gases (PaCO2)|Arterial blood gases will be collected.|15 minutes after device activation|||mmHg|||Number
662296|NCT01824589|Secondary|Lung Compliance|Change in lung compliance following each ITPR treatment compared to baseline.|baseline and immediately after device removal|||ml/cmH2O|||Number
662297|NCT01824589|Secondary|Cerebral Perfusion Pressure (CPP)|Measurement of the difference between baseline CPP and CPP at 15 minutes|15 minutes after device activation|||mmHg|||Number
662298|NCT01824589|Primary|Intracranial Pressure (ICP)|Change in ICP from baseline will be compared with the ICP during 15 minutes of ITPR use.|15 minutes after device is activated|||mmHg|||Number
662299|NCT01824576|Secondary|Change From Baseline in Oxygen Saturation (SpO2)|Measure change in SpO2 average during baseline and 15 minutes following removal of the ITPR|basseline to 15 minutes following device use|||percentage of saturation||Standard Deviation|Mean
662300|NCT01824576|Secondary|Change From Baseline in End-tidal Carbon Dioxide (EtCO2)|Measure change in EtCO2 average during baseline and 15 minutes following removal of the ITPR|baseline to 15 minutes following device use|||mmHg||Standard Deviation|Mean
662301|NCT01824576|Secondary|Change From Baseline in Pulse Pressure (PP)|Measure change in pulse pressure average during baseline and 15 minutes following removal of the ITPR|baseline to 15 minutes following device use|||mmHg||Standard Deviation|Mean
662302|NCT01824576|Secondary|Change From Baseline in Heart Rate (HR)|Measure change in heart rate average during baseline and 15 minutes following removal of the ITPR|baseline to 15 minutes following device use|||beats/min||Standard Deviation|Mean
662303|NCT01824576|Secondary|Change From Baseline in Mean Arterial Pressure (MAP)|Measure change in mean arterial pressure average during baseline and 15 minutes following removal of the ITPR|baseline to 15 minutes following device use|||mmHg||Standard Deviation|Mean
662304|NCT01824576|Secondary|Change From Baseline in Diastolic Blood Pressure (DBP)|Measure change in diastolic blood pressure average during baseline and 15 minutes following removal of the ITPR|baseline to 15 minutes following device use|||mmHg||Standard Deviation|Mean
662305|NCT01824576|Secondary|Change From Baseline in PaCO2|PaCO2 will be collected during baseline and 15 minutes after device activation and change will be evaluated.|baseline and 15 minutes after device activation|PaCO2 values for comparison were not available for two subjects||mmHg||Standard Deviation|Mean
662306|NCT01824576|Secondary|Change From Baseline in Systolic Blood Pressure (SBP)|Measure change in systolic blood pressure average during baseline and 15 minutes following removal of the ITPR|baseline to15 minutes following device use|||mmHg||Standard Deviation|Mean
662307|NCT01824576|Primary|Change From Baseline in Cerebral Perfusion Pressure (CPP)|Change from average baseline CPP compared with the average CPP during use of the ITPR.|During 120 minutes of device use|||mmHg||Standard Deviation|Mean
662308|NCT01824498|Primary|E2|Estradiol|8 weeks|||pmol/L||Standard Error|Least Squares Mean
662309|NCT01824498|Primary|Plasma Sex Hormone Levels||8 weeks||||||
662310|NCT01824446|Primary|Percent Total Radioactivity Excreted in Stool of Radiolabelled SSP-004184||Up to 288 hours post-dose|PAS||percentage of radioactivity||Standard Deviation|Mean
662311|NCT01824446|Primary|Percent Total Radioactivity Excreted in Urine of Radiolabelled SSP-004184||Up to 288 hours post-dose|PAS||percentage of radioactivity||Standard Deviation|Mean
662312|NCT01824446|Primary|Vz/F Plasma Total Radioactivity of Radiolabelled SSP-004184||Up to 288 hours post-dose|PAS||Liters||Standard Deviation|Mean
662313|NCT01824446|Primary|CL/F Plasma Total Radioactivity of Radio-Labelled SSP-004184||Up to 288 hours post-dose|PAS||L/hr||Standard Deviation|Mean
662314|NCT01824446|Primary|Half-Life Plasma Total Radioactivity of Radiolabelled SSP-004184||Up to 288 hours post-dose|PAS||hours||Standard Deviation|Mean
662315|NCT01824446|Primary|Tmax Plasma Total Radioactivity of Radiolabelled SSP-004184||Up to 288 hours post-dose|PAS||hours||Full Range|Median
662316|NCT01824446|Primary|Cmax Plasma Total Radioactivity of Radiolabelled SSP-004184||Up to 288 hours post-dose|PAS||ng equivalents/ml||Standard Deviation|Mean
662317|NCT01824446|Primary|AUC 0→∞ Plasma Total Radioactivity of Radiolabelled SSP-004184||Up to 288 hours post-dose|PAS||ng equivalents*hr/ml||Standard Deviation|Mean
662318|NCT01824446|Primary|Vz/F Whole Blood Total Radioactivity of Radiolabelled SSP-004184||Up to 288 hours post-dose|PAS||Liters||Standard Deviation|Mean
662319|NCT01824446|Primary|CL/F Whole Blood Total Radioactivity of Radio-Labelled SSP-004184||Up to 288 hours post-dose|PAS||L/hr||Standard Deviation|Mean
662320|NCT01824446|Primary|Half-Life Whole Blood Total Radioactivity of Radiolabelled SSP-004184||Up to 288 hours post-dose|PAS||hours||Standard Deviation|Mean
662321|NCT01824446|Primary|Tmax Whole Blood Total Radioactivity of Radiolabelled SSP-004184||Up to 288 hours post-dose|PAS||hours||Full Range|Median
662329|NCT01824446|Primary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) of Radiolabelled SSP-004184|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Up to 288 hours post-dose|The Pharmacokinetic Analysis Set (PAS) was defined as all subjects in the Safety Analysis Set (SAS) for whom the primary pharmacokinetic data are considered sufficient and interpretable. The SAS consisted of subjects who received at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||ng*hr/ml||Standard Deviation|Mean
662330|NCT01824355|Secondary|Number of Subject Responses That 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements|Staff obtained subject responses using short questionnaires to provide feedback on instructions for use and the basic operation of the BGMS. Subjects could respond 'Strongly Agree' 'Agree' 'Neutral' 'Disagree' or 'Strongly Disagree.'|1 hour|Four subjects of those enrolled (113 subjects) had either missing or unevaluable questionnaire data.||participants|||Number
662331|NCT01824355|Secondary|Percent of Fingerstick Blood Glucose Results Within ±15 mg/dL (< 75 mg/dL) and Within ±20% (≥ 75 mg/dL) of the Laboratory Glucose Method When Tested by Study Staff|Study Staff tested subject fingerstick blood using the Ninja 3 PLUS investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with capillary plasma BG results obtained with a reference laboratory glucose method – YSI Life Sciences (YSI) Analyzer. BG meter results were used to calculate the number of BGMS results within +/- 15mg/dL (for reference BG results <75mg/dL) and within +/- 20% (for reference BG results >=75mg/dL) of the YSI reference method results.|one hour|220 Blood Glucose results were analyzed. Study Staff provided 2 Blood Glucose Test Results from each subject who completed (110 subjects) the study.||percentage of Blood Glucose Results|Participants||Number
662332|NCT01824355|Secondary|Percent of Blood Glucose Results From Alternative Site Testing (AST) of the Palm Within ±15 mg/dL (< 75 mg/dL) and Within ±20% (≥ 75 mg/dL) of the Laboratory Method.|Untrained subjects with diabetes self-tested Alternative Site (AST) Palm blood using the Ninja 3 PLUS investigational Blood Glucose Monitoring System (BGMS). BGMS AST results were compared with capillary plasma BG results obtained with a reference laboratory glucose method – YSI Life Sciences (YSI) Analyzer. BG meter results were used to calculate the number of AST BGMS results within +/- 15mg/dL (<75mg/dL YSI capillary plasma) and within +/- 15% (>=75mg/dL YSI capillary plasma).|1 hour|209 (220-11) Blood Glucose results were analyzed. 2 subjects had low blood sugar and per protocol their 4 AST BG results were not evaluable. 3 BG results were excluded as they were protocol deviations. One subject (2 BG results) did not complete testing within protocol timeframe and one subject (2 BG results) was unable to obtain AST blood.||percentage of AST Blood Glucose Results|Participants||Number
662333|NCT01824355|Secondary|Percent of Self Test Fingerstick Blood Glucose Results Within ±12.5 mg/dL (< 100 mg/dL) and Within ±12.5% (≥ 100 mg/dL) of the Laboratory Glucose Method|Untrained subjects with diabetes who self-tested fingerstick blood used the Ninja 3 PLUS investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with capillary plasma BG results obtained with a reference laboratory glucose method – YSI Life Sciences (YSI) Analyzer. BG meter results were used to calculate the number of BGMS results within +/- 12.5mg/dL (for reference BG results <100mg/dL) and within +/- 12.5% (for reference BG results >=100mg/dL) of the YSI reference method results.|1 hour|220 Blood Glucose results were analyzed. Each subject who completed (110 subjects) the study provided 2 Blood Glucose test results.||percentage of Blood Glucose Results|Participants||Number
662334|NCT01824355|Secondary|Percent of Self Test Fingerstick Blood Glucose Results Within ±15 mg/dL (< 100 mg/dL) and Within ±15% (≥ 100 mg/dL) of the Laboratory Glucose Method|Untrained subjects with diabetes who self-tested fingerstick blood used the Ninja 3 PLUS investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with capillary plasma BG results obtained with a reference laboratory glucose method – YSI Life Sciences (YSI) Analyzer. BG meter results were used to calculate the number of BGMS results within +/- 15mg/dL (for reference BG results <100mg/dL) and within +/- 15% (for reference BG results >=100mg/dL) of the YSI reference method results.|1 hour|220 Blood Glucose results were analyzed. Each subject who completed (110 subjects) the study provided 2 Blood Glucose test results.||percentage of Blood Glucose Results|Participants||Number
662335|NCT01824355|Primary|Percent of Self Test Fingerstick Blood Glucose Results Within ±15 mg/dL (< 75 mg/dL) and Within ±20% (≥ 75 mg/dL) of the Laboratory Glucose Method|Untrained subjects with diabetes who self-tested fingerstick blood used the Ninja 3 PLUS investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with capillary plasma BG results obtained with a reference laboratory glucose method – YSI Life Sciences (YSI) Analyzer. BG meter results were used to calculate the number of BGMS results within +/- 15mg/dL (for reference BG results <75mg/dL) and within +/- 20% (for reference BG results >=75mg/dL) of the YSI reference method results.|1 hour|220 Blood Glucose results were analyzed. Each subject who completed (110 subjects) the study provided 2 Blood Glucose test results.||percentage of BG results|Participants||Number
662336|NCT01824342|Secondary|Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)|A scale used to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis. 0 = Fully active, able to carry out all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature (e.g., light housework, office work); 2 = Ambulatory and capable of all self care, but unable to carry out any work activities. Up and about more than 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4 = Completely disabled. Cannot carry out any self-care. Totally confined to bed or chair; 5 = Dead.|Baseline and Week 49|Safety analysis set with available data at both time points||participants|||Number
662337|NCT01824342|Primary|Number of Participants With Anti-denosumab Neutralizing Antibody Formation||3 years|Participants exposed to open-label denosumab with ≥ 1 antibody sample||participants|||Number
662338|NCT01824342|Primary|Percent Change From Baseline in Laboratory Values||Baseline and Week 49|Safety analysis set with available laboratory data at each time point.||percent change||Standard Deviation|Mean
662479|NCT01821417|Secondary|Changes in Peri-implant Gingivitis Score|Measurement of changes in peri-implant gingivitis score [Loe and Silness gingival index (GI)] after implant restoration|1 year after placement|No data was collected. Previously entered data was entered incorrectly.|||||
662339|NCT01824342|Primary|Number of Participants With Treatment-emergent Adverse Events (AEs) and Deaths|A serious adverse event is defined as an adverse event that meets at least one of the following serious criteria: • fatal, • life threatening, • requires in-patient hospitalization or prolongation of existing hospitalization, • results in persistent or significant disability/incapacity, • congenital anomaly/birth defect, and/or • other significant medical hazard. The adverse event severity grading scale used was the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, according to the following: Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE; Grade 5 = Death related to AE. The investigator assessed whether each adverse event was possibly related to the investigational product (IP).|From the first dose of open-label denosumab until 4 weeks after the last; maximum time on study was 37 months. Follow-up survival information was collected for up to 3 years after the last dose of blinded investigation product in the 20050147 study.|Safety analysis set, which included participants who had properly documented informed consent for protocol 20080585 and received at least 1 dose of open-label denosumab.||participants|||Number
662340|NCT01824303|Secondary|Change From Baseline in Brief Pain Inventory (BPI)|The BPI is a 7-item participant completed questionnaire. The participant answered questions as to how pain interfered with: General Activity, Mood, Walking Ability, Normal work, Relations with other people, Sleep and Enjoyment of life. Questions were answered on an 11-point scale where: 0=Does not interfere to 10=Completely interferes. The total score is the average of the individual questionnaire items for a total possible score of 0 (best) to 10 (worst). A negative change from Baseline indicates improvement.|Baseline, Day 27|Participants from the ITT population, all randomized participants, with data available for analyses.||score on a scale||Standard Deviation|Mean
662341|NCT01824303|Secondary|Change From Baseline in Bladder Pain/Interstitial Cystitis Symptom Score (BPIC-SS)|The BPIC-SS is a participant reported questionnaire consisting of 8 items. Questions (Q) 1-5 (How often urination because of pain; Need to urinate after just urinating; How often urination to avoid worse pain; How often feeling of pressure in bladder; How often pain in bladder) answered on a 5-point scale where: 0=Never to 4=Always. Q 6-7 (Bothered by frequent Day-time urination; Bothered by Night-time urination) answered on a 5-point scale where: 0=Not At All to 4=A Great Deal. Q8 (pain) rated on a NRS by putting a mark on the line where: 0 (the far left of the line)=no pain to 10 (far right of the line)=worst pain imaginable. The Total Score is the sum of the individual questionnaire of all 8 items for a total possible score of 0 (best) to 38 (worst). A negative change indicates improvement.|Baseline, Day 27|Participants from the ITT population, all randomized participants, with data available for analyses.||score on a scale||Standard Deviation|Mean
662342|NCT01824303|Secondary|Change From Baseline in O’Leary-Sant Interstitial Cystitis Problem Index (ICPI) Score|The ICPI is a participant reported questionnaire to rate their problems in the following 4 areas: Frequent urination; Getting up at Night to Urinate: Urination with little warning; Burning pain and discomfort. Questions are answered on a 5-point scale where: 0=No Problem to 4=Big Problem. The total score is the sum of the individual scores for a total possible score of 0 (best) to 20 (worst). A negative change from Baseline indicates improvement.|Baseline, Day 27|Participants from the ITT population, all randomized participants, with data available for analyses.||score on a scale||Standard Deviation|Mean
662343|NCT01824303|Secondary|Change From Baseline in O’Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score|The ICSI is a participant reported questionnaire to rate their symptoms by answering 4 questions. Question (Q) 1 and 2 (urine urgency) using a 6-point scale where: 0=Not at All to 5=Almost Always. Q3 (night-time voids) using a 6-point scale where: 0=None to 5=5 or More Times. Q4 (pain and burning) using a 6-point scale where: 0=Not at All to 5=Usually. The total score is the sum of the individual scores for a total possible score of 0 (best) to 20 (worst). A negative change from Baseline indicates improvement.|Baseline, Day 27|Participants from the ITT population, all randomized participants, with data available for analyses.||score on a scale||Standard Deviation|Mean
662344|NCT01824303|Secondary|Change From Baseline in Post-Void Bladder Pain|Participants rated their bladder pain immediately completing voiding in an electronic diary using a horizontal line NRS by putting a mark on the line where: 0 (the far left of the line)=no pain to 10 (far right of the line)=worst pain imaginable. The average of the data from the first 5 voids prior to Baseline and the 3 days prior to Day 12 were averaged for analyses. A negative change from Baseline indicates improvement.|Baseline, Day 27|Participants from the ITT population, all randomized participants, with data available for analyses.||units on a scale||Standard Deviation|Mean
662345|NCT01824303|Secondary|Change From Baseline in Average Void Volume Per Micturition|Participants recorded the amount of each void in millimeters (mL) in an electronic diary. The total amount of void per micturition (each void) was averaged over a period of 24 days. A negative change from Baseline indicates improvement.|Baseline, Day 27|Participants from the ITT population, all randomized participants, with data available for analyses.||mL||Standard Deviation|Mean
662346|NCT01824303|Secondary|Change From Baseline in Night-Time Daily Voids|Participants recorded number of night-time daily voids in a 3 day Voiding Frequency electronic diary. The total number of night-time daily voids was averaged over a period of 3 days. A negative change from Baseline indicates improvement.|Baseline, Day 27|Participants from the ITT population, all randomized participants, with data available for analyses.||voids||Standard Deviation|Mean
662347|NCT01824303|Secondary|Change From Baseline in Total Daily Voids|Participants recorded number of daily voids (day-time and night-time daily voids) in a 3 day Voiding Frequency electronic diary. The total number of daily voids was averaged over a period of 3 full days. A negative change from Baseline indicates improvement.|Baseline, Day 27|Participants from the ITT population, all randomized participants, with data available for analyses.||voids||Standard Deviation|Mean
662348|NCT01824303|Primary|Change From Baseline in Participant Reported Average Bladder Pain on a Numerical Rating Scale (NRS)|Participants rated their bladder pain over the previous 24 hours in an electronic diary using a horizontal line NRS by putting a mark on the line where: 0 (the far left of the line)=no pain to 10 (far right of the line)=worst pain imaginable. Bladder pain was averaged over a period of 3 days. A negative change from Baseline indicates improvement.|Baseline, Day 12|Intent-to-treat (ITT) population included all randomized participants.||unit on a scale||Standard Deviation|Mean
662480|NCT01821417|Primary|Change in Millimeters of Bone Loss Surrounding the Implant Device|Using radiographic images and image-processing software, measurements of bone height at the mesial and distal of each implant will be captured in millimeters.|Implant insertion, 12 months post-insertion|||millimeters||Standard Deviation|Mean
662349|NCT01824160|Primary|Successful Repair of Conduit Disruption|"Successfully cover a tear or disruption in a RV-PA conduit wall and prevent the development of rupture or bleeding into the mediastinum during additional enlargement of the conduit. Provide persistent conduit wall integrity.
A severity of illness scale categorizes the degree of clinical illness at baseline to be compared to the remaining level of illness after placement of the Covered CP Stent (CCPS). We assess the number of participants with minimal level of illness (level 0 to 1) after CCPS placement.
0 = No injury or conduit wall disruption
= Contained disruption
= Partially contained disruption
= Uncontained conduit disruption"|Implant of Covered Stent and 6 month follow up|||participants|||Number
662350|NCT01823679|Secondary|Overall Survival (OS) at 2 Years|Proportion of participants with overall survival (OS) at 2 years, as calculated based on Kaplan-Meier estimates.|2 years|||percentage of participants|||Number
662351|NCT01823679|Secondary|Overall Survival (OS) at 1 Year|Proportion of participants with overall survival (OS) at 1 year, as calculated based on Kaplan-Meier estimates.|1 year|||percentage of participants|||Number
662352|NCT01823679|Secondary|Progression-free Survival (PFS) at 2 Years|Proportion of participants with progression-free survival (PFS) at 2 years, as calculated based on Kaplan-Meier estimates.|2 years|||percentage of participants|||Number
662353|NCT01823679|Secondary|Progression-free Survival (PFS) at 1 Year|Proportion of participants with progression-free survival (PFS) at 1 year, as calculated based on Kaplan-Meier estimates.|1 year|||percentage of participants|||Number
662354|NCT01823679|Primary|Objective Response Rate (ORR)|Response assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)|9 weeks (3 cycles)|||percentage of participants|||Number
662355|NCT01823653|Secondary|Global Aesthetic Improvement Scale (GAIS) Score Post Treatment Assessed by Investigator for Determining Clinical Improvement|"Mean Investigator improvement at 12 weeks using the GAIS Scale.
*GAIS Scale: 1=Much Worse, 2=Worse, 3=No Improvement, 4=Improved, 5=Much Improved"|12 weeks|Per protocol||units on a scale||Standard Deviation|Mean
662356|NCT01823653|Secondary|Subcutaneous Adipose Thickness|Ultrasound assisted measurement of adipose tissue thickness|12 weeks||||||
662357|NCT01823653|Secondary|Safety Assessment|Discomfort level during treatment using the Visual Analog Scale (VAS) and post-treatment skin reponses or side effects using a 0-3 severity scale.|1, 4, 8, 12 weeks||||||
662358|NCT01823653|Secondary|Patient Satisfaction Using 1-5 Likert Scale|Likert scale ranges from 1=Very Dissatisfied to 4=satisfied, 5=very satisfied. Percentage of participants rated 4 and 5 are reported below|12 weeks|Per protocol||percentage of subjects satisfied|||Number
662359|NCT01823653|Secondary|Percentage of Participants Showing Clinical Improvement Using the Global Aesthetic Improvement Scale (GAIS) Post Treatment, Assessed by Investigator|"Investigator improvement at 12 weeks using the GAIS Scale, as presented based on percentage of subjects showing improvement. Outcome presented in % of participants that had GAIS scores of either 4 (improved) or 5 (much improved) at 12 weeks post treatment.
*GAIS Scale: 1=Much Worse, 2=Worse, 3=No Improvement, 4=Improved, 5=Much Improved"|12 weeks|Per protocol||Percentage of subjects improved|||Number
662360|NCT01823653|Primary|Clinical Improvement in Thigh Circumference|Clinical improvement measured by change from baseline thigh circumference after treatment|12 weeks (minus baseline)|Per Protocol||centimeter||Standard Error|Least Squares Mean
662361|NCT01823614|Other Pre-specified|Estimation of the R5- and X4-tropic HIV Variants Ratio Stratified by CD4 Cell Count Among Naive Patients||24 weeks|||participants|||Number
662362|NCT01823614|Secondary|Estimation of the R5- and X4-tropic HIV Variants Ratio Stratified by CD4 Cell Count||24 weeks|||participants|||Number
662363|NCT01823614|Primary|Determination of the Prevalence of R5 and X4-tropic Variants of HIV in HIV-infected Population in Russia||24 weeks|||participants|||Number
662364|NCT01823536|Secondary|Number of Subjects Reporting Unsolicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study.|The safety and tolerability of one injection of MenACWY-CRM vaccine, administered in the present study, was evaluated in terms of the number of subjects reporting unsolicited adverse events, serious adverse events and adverse events leading to premature withdrawal.|Day 1 to day 28|The analysis was done on unsolicited safety set, ie, all exposed subjects who provided unsolicited adverse events (AE) data.||Number of subjects|||Number
662365|NCT01823536|Secondary|Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study.|"The number of subjects reporting solicited local and systemic adverse events after one injection of MenACWY-CRM vaccine was administered in the present study to,
Subjects, who had 5 years earlier received either one or two doses of MenACWY-CRM vaccine
Vaccine-naive subjects."|Day 1 to day 7 post-vaccination|The analysis was done on solicited safety set, ie, all subjects in the exposed set who provided post vaccination solicited reactogenicity data.||Number of subjects|||Number
662366|NCT01823536|Secondary|Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study.|The antibody response against N.meningitidis serogroups A, C, W and Y, at one month after one injection of Men ACWY-CRM vaccine was administered in the present study to subjects who had received either one or two doses of MenACWY-CRM vaccine 5 years earlier and to age matched naive subjects, is evaluated in terms of GMTs.|Day 28 post-vaccination|The analysis was done on per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
662367|NCT01823536|Secondary|Percentages of Subjects With hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study.|The antibody response against N.meningitidis serogroups A, C, W and Y, at one month after one injection of Men ACWY-CRM vaccine was administered in the present study to subjects who had received either one or two doses of MenACWY-CRM vaccine 5 years earlier and to age matched naive subjects, is evaluated in terms of the percentages of subjects with hSBA titers ≥1:8.|Day 28 post-vaccination|The analysis was done on per-protocol population.||Percentages of subjects||95% Confidence Interval|Number
662368|NCT01823536|Secondary|Percentages of Subjects With Persisting hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y as Compared to Age Matched Vaccine-naive Subjects|The percentages of subjects with persisting serum bactericidal antibody ≥1: 8, against N.meningitidis serogroups A, C, W and Y, after having received one or two doses of MenACWY-CRM vaccine five years earlier in the parent study, are compared with the hSBA response in age matched vaccine-naive subjects.|5 years post-vaccination; baseline for naive|The analysis was done on per-protocol population.||Percentages of subjects||95% Confidence Interval|Number
662369|NCT01823536|Secondary|Persisting Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W and Y in Subjects, Five Years After Having Received One or Two Doses of MenACWY-CRM Vaccine.|The persistence of geometric mean titers (GMTs) against N.meningitidis serogroups A, C, W and Y in subjects who had received one or two doses of MenACWY-CRM vaccine, five years earlier in the parent study, are reported.|5 years post-vaccination|The analysis was done on per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
662370|NCT01823536|Primary|Percentages of Subjects With Persisting hSBA Titers ≥1:8 Against Neisseria Meningitidis (N. Meningitidis) Serogroups A, C, W and Y, Five Years After Having Received One or Two Doses of MenACWY-CRM Vaccine|"The percentages of subjects with persisting serum bactericidal antibody ≥1: 8, against N.meningitidis serogroups A, C, W and Y, after having received one or two doses of MenACWY-CRM vaccine, five years earlier in the parent study, are reported.
The serum bactericidal antibodies directed against N.meningitidis serogroups, are measured by human complement Serum Bactericidal Assay (hSBA)."|5 years post-vaccination|The analysis was done on per-protocol population i.e all subjects who provided immunogenicity data; had no major protocol deviations and who were not excluded due to other reasons defined prior to analysis.||Percentages of subjects||95% Confidence Interval|Number
662371|NCT01823510|Secondary|Platelet Reactivity Index (PRI)|Platelet reactivity index by Vasodilator-Stimulated Phosphoprotein phosphorylation (VASP) assay.|up to 7 days|||percentage of baseline PRI||Standard Error|Mean
662372|NCT01823510|Secondary|P2Y12 Reaction Unit (PRU)|Platelet reactivity by measuring P2Y12 Reaction Unit using Accumetrics VerifyNow|up to 7 days|||percentage of baseline PRU||Standard Error|Mean
662373|NCT01823510|Secondary|Platelet Reactivity|Platelet reactivity by Multiplate Analyzer|up to 7 days|||percentage of baseline Unit||Standard Error|Mean
662374|NCT01823510|Primary|Thrombus Formation|Thrombus formation in Badimon Perfusion Chamber high-shear) (ex vivo model of thrombosis).|up to 7 days|||percentage of baseline size||Standard Error|Mean
662375|NCT01823341|Secondary|Percent of Mornings With Urine Ketones >/= 15 mg/dl|Urine ketones measured each morning with Ketostix.|Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use|"One participant in the 4-10 year old group with 5 intervention nights and 5 control nights was excluded for <80h of CGM glucose data. We considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal an thus our final analyses had a slightly higher number of nights than expected."||percentage of mornings|Participants||Number
662376|NCT01823341|Secondary|Morning Blood Ketones >=1.0 mmol/L|"Please note we considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal and thus our final analyses had a slightly higher number of nights than expected."|Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use|"One participant in the 4-10 year old group with 5 intervention nights and 5 control nights was excluded for <80h of CGM glucose data. We considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal an thus our final analyses had a slightly higher number of nights than expected."||percentage of mornings|Participants||Number
662377|NCT01823341|Secondary|Percentage of Mornings With Blood Glucose >250 mg/dL (>13.9 mmol/L)|"Please note we considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal and thus our final analyses had a slightly higher number of nights than expected."|Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use|"One participant in the 4-10 year old group with 5 intervention nights and 5 control nights was excluded for <80h of CGM glucose data. We considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal an thus our final analyses had a slightly higher number of nights than expected."||percentage of mornings|Participants||Number
662378|NCT01823341|Secondary|Mean Morning Blood Glucose|"Please note we considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal and thus our final analyses had a slightly higher number of nights than expected."|Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use|"One participant in the 4-10 year old group with 5 intervention nights and 5 control nights was excluded for <80h of CGM glucose data. We considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal an thus our final analyses had a slightly higher number of nights than expected."||mg/dL|Participants|Standard Deviation|Mean
662379|NCT01823341|Secondary|Percentage of Overnight Time Spent With CGM Value >250 mg/dL (13.9 mmol/L), Normalized to an 8-hour Period.|"Please note we considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal and thus our final analyses had a slightly higher number of nights than expected."|Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use|"One participant in the 4-10 year old age group with 5 intervention nights and 5 control nights was excluded for <80h of CGM glucose data. We considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal an thus our final analyses had a slightly higher number of nights than expected."||percentage of time|Participants|Inter-Quartile Range|Median
662380|NCT01823341|Secondary|Percentage of Time Overnight Sensor Glucose Values 71 to 180 mg/dL (3.9 to 10.0 mmol/L), Normalized to an 8-hour Period.|"Please note we considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal and thus our final analyses had a slightly higher number of nights than expected."|Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use|"One participant in the 4-10 year old group with 5 intervention nights and 5 control nights was excluded for <80h of CGM glucose data. We considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal an thus our final analyses had a slightly higher number of nights than expected."||percentage of time|Participants|Standard Deviation|Mean
662381|NCT01823341|Secondary|Mean Sensor Glucose Overnight|"Please note we considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal and thus our final analyses had a slightly higher number of nights than expected."|Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use|"One participant in the 4-10 year old age group with 5 intervention nights and 5 control nights was excluded for <80h of CGM glucose data. We considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal an thus our final analyses had a slightly higher number of nights than expected."||mg/dL|Participants|Standard Deviation|Mean
662382|NCT01823341|Secondary|Percentage of Nights With 1 or More Sensor Glucose Values <50 mg/dL (<2.8 mmol/L)|"Please note we considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal and thus our final analyses had a slightly higher number of nights than expected."|Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use|"One participant in the 4-10 year old group with 5 intervention nights and 5 control nights was excluded for <80h of CGM glucose data. We considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal an thus our final analyses had a slightly higher number of nights than expected."||percentage of nights|Participants||Number
662383|NCT01823341|Secondary|Percentage of Nights With 1 or More Sensor Glucose Values <70 mg/dL (<3.9 mmol/L)|"Please note we considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal and thus our final analyses had a slightly higher number of nights than expected."|Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use.|"One participant in the 4-10 year old group with 5 intervention nights and 5 control nights was excluded for <80h of CGM glucose data. We considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal an thus our final analyses had a slightly higher number of nights than expected."||percentage of nights|Participants||Number
662384|NCT01823341|Primary|Comparison of the Time Spent in Hypoglycemia (<70 mg/dl, 3.9 mmol/L) Overnight on Intervention Nights Versus Control Nights, Normalized to an 8-hour Period.|"Each night is categorized as to whether hypoglycemia occurred. Hypoglycemia is defined as the occurrence of one or more CGM glucose values ≤70 mg/dL (3.9 mmol/L). The time period for outcome assessment each night will be from the time the system is activated in the evening until the time it is deactivated in the morning. The percentage of hypoglycemic nights (CGM glucose value ≤70 mg/dL (3.9 mmol/L)) will be tabulated separately with versus without the closed-loop control system in use. We considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal and thus our final analyses had a slightly higher number of nights than expected."|Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use.|"One participant in the 4-10 year old age group with 5 intervention nights and 5 control nights was excluded for <80h of CGM glucose data. We considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal and thus our final analyses had a slightly higher number of nights than expected."||percentage of time|Participants|Inter-Quartile Range|Median
662385|NCT01823289|Primary|Number of Participants With Comprehensive Efficacy|Comprehensive efficacy was assessed as cured: the symptoms, signs, laboratory examination and pathogenic examination were return to normal; markedly improved: the disease condition was markedly improved but symptoms, signs, laboratory examination and pathogenic examination were not return to normal; improved: the disease condition was improved to some extent after drug administration, but the improvement was not significant enough; failed: the disease condition was not improved significantly or worsened after drug administration.|Week 6|The Full analysis set (FAS) population included all participants who received at least 1 intravenous infusion or oral solution of the study drug and completed at least 1 post-baseline visit.||participants|||Number
662386|NCT01823289|Primary|Number of Participants With Mycological Efficacy|Mycological efficacy was assessed as fungi cleared: negative for fungal microscopic examination and culture (test for infection or organisms that could cause infection); fungi not cleared: positive for fungal microscopic examinations and/or culture.|Week 6|The Full analysis set (FAS) population included all participants who received at least 1 intravenous infusion or oral solution of the study drug and completed at least 1 post-baseline visit. Here 'N' signifies those participants who were evaluable for this measure.||participants|||Number
662387|NCT01823289|Primary|Number of Participants With Clinical Efficacy|Clinical efficacy was assessed as cured: the signs and symptoms of invasive fungal infections (IFI) completely disappeared or full or nearby resolution of radiographic manifestations; markedly improved: the signs and symptoms of IFI were improved or disappeared and at least 50 percent improvement of radiographic findings; improved: the signs and symptoms of IFI were moderately improved and less than 50 percent improvement of radiographic findings; failed: the clinical symptoms and signs of IFI were not changed or worsened.|Week 6|The Full analysis set (FAS) population included all participants who received at least 1 intravenous infusion or oral solution of the study drug and completed at least 1 post-baseline visit.||participants|||Number
662388|NCT01823224|Secondary|Total Opioid Consumption From Time of First Waking to T24|"Pain diary will be filled out every 6 hours for 24 hours after discharge in which the following will be recorded:
Opioid consumption from first waking to T4
Total opioid consumption from T0 to T4
Total opioid consumption from time of first waking to T24"|every 6 hours for 24 hours|||milligrams||Standard Deviation|Mean
662389|NCT01823224|Primary|Pain|Pain after treatment with IV versus oral tylenol will be assessed via pain scores utilizing an numerical rating scale (NRS) )0-10 with 0 as no pain and 10 as worst pain with 5 as moderate pain and faces accompanied the scores with full smile on no pain to tears and frown on worst pain.|24 hours after discharge|||NRS scale||Standard Deviation|Mean
662390|NCT01823146|Secondary|Functional Connectivity (Resting fMRI)|The functional connectivity (strength measure in units on a scale) between amygdala and medial prefrontal cortex was measured via a resting functional magnetic resonance imaging scan (participants looked at a fixation cross while images of their brain at rest were taken). Functional connectivity is the connectivity between brain regions (i.e., amygdala and medial prefrontal cortex) that share functional properties. It is defined as the temporal correlation between spatially remote neurophysiological events, expressed as deviation from statistical independence across these events in distributed neuronal groups and areas. A mean of this correlation (connectivity strength) was computed and transformed into z-scores (r to z transformation). The z-scores ranged from -2 to +2 with higher scores representing a greater resting-state functional connectivity.|1.5 hours after oxytocin/placebo administration|All study participants who had undergone the screening as well as the full visit and had reliable resting fMRI scan data (e.g., low extent of head motion) (n = 79).||z-scores||95% Confidence Interval|Least Squares Mean
662391|NCT01823146|Secondary|Meta-Mood|Mean self-reported level of meta-mood for the two subscales attention to feelings and clarity of feelings. Response scale ranged from 1 to 5, with higher scores indicating more attention to feelings and greater clarity of feelings, respectively. The mean score for the subscales were calculated.|2.5 hours after drug/placebo administration|All study participants who had undergone the screening as well as the full visit (n = 102).||units on a scale||Standard Error|Mean
662392|NCT01823146|Primary|Extent of Trust Behavior|"Average amount of monetary units invested in the context of the Trust/Lottery Game.
The theoretical range was 0 to 72 monetary units across all 24 trials. Participants invested in 12 social (human person) and 12 non-social (computer) trials.The mean average amount of monetary units invested was calculated for social and non-social trials separately."|45 minutes after drug/placebo administration|All study participants who had undergone the screening as well as the full visit (n = 102).||monetary units||Standard Error|Mean
662393|NCT01822899|Secondary|Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) at Day 85|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. BL is defined as the mean of the assessments made 30 and 5 minutes (min) pre-dose on Treatment Day 1. Trough FEV1 on Day 85 is defined as the mean of the FEV1values obtained 23 and 24 hours after the previous morning's dosing (i.e., trough FEV1 on Day 85 is the mean of the FEV1 values obtained 23 and 24 hours after morning dosing on Day 84). Analysis was performed using a repeated measures model with covariates of treatment, BL (mean of the two assessments made 30 min and 5 min pre-dose on Day 1), smoking status, day, and day by BL and day by treatment interactions. The model used all available trough FEV1 values recorded on Days 28, 56, 84, and 85. Missing data were not directly imputed in this analysis; however, all non-missing data for a participant were used within the analysis to estimate the treatment effect for trough FEV1 at Day 85.|Baseline and Day 85|ITT Population. Participants analyzed were those with data available at the presented time point; but, all participants without missing covariate information were included in the analysis.||Liters||Standard Error|Least Squares Mean
662394|NCT01822899|Primary|Change From Baseline (BL) in 0 to 24 Hour Weighted Mean Serial Forced Expiratory Volume in One Second (FEV1) at Day 84|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The weighted mean was calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5 and 15 minutes and 1, 3, 6, 9, 12 (pre-evening dose), 13, 15, 18, 23, and 24 hours after the morning dose. Analysis was performed using an analysis of covariance (ANCOVA) model with covariates of treatment, Baseline FEV1 (mean of the two assessments made 30 minutes and 5 minutes pre-dose on Day 1), and smoking status.|Baseline and Day 84|Intent-to-Treat (ITT) Population: all participants (par.) randomized to treatment who received at least one dose of randomized study drug in the Treatment Period. Par. analyzed were those with data available at the presented time point but all par. without missing covariate information and with >= post BL measurement were included in the analysis.||Liters||Standard Error|Least Squares Mean
662395|NCT01822821|Secondary|Total Bilirubin (mg/dL)||Measured at 1 day and 2 days after surgery|||mg/dL||Inter-Quartile Range|Median
662396|NCT01822821|Secondary|Aspartate Aminotransferase (AST); U/L||Two days after surgery or date of death from any cause, whichever came first|||U/L||Inter-Quartile Range|Median
662397|NCT01822821|Secondary|Alanine Aminotransferase (ALT); U/L||Two days after surgery or date of death from any cause, whichever came first|||U/L||Inter-Quartile Range|Median
662398|NCT01822821|Secondary|Hospital Length of Stay|Evaluate whether IV acetaminophen hospital length of stay|end of surgery through hospital discharge|||days||Inter-Quartile Range|Median
662399|NCT01822821|Secondary|Intensive Care Unit (ICU) Length of Stay|Evaluate whether IV acetaminophen reduced intensive care unit (ICU) Length of Stay.|End of surgery through discharge from ICU|||hours||Inter-Quartile Range|Median
662400|NCT01822821|Secondary|Duration of Mechanical Ventilation (Minutes)|Evaluate whether IV acetaminophen reduced duration of Mechanical Ventilation.|End of surgery until the initial end of ventilation or date of death from any cause, whichever came first, assessed up to 1 week.|||minutes||Inter-Quartile Range|Median
662401|NCT01822821|Secondary|Postoperative Sedation|Postoperative sedation was assessed using the Richmond Agitation Sedation Scale (RASS). It ranges from -5 to +4, where -5 indicates no response to voice or physical stimulation and +4 indicates overtly combative or violent and immediate danger to staff. Lower the value, better the sedation.|Measured at 8, 16, and 24 hours after surgery|RASS scores were not collected at certain time points if patients were not available (e.g., patient was away at a test) or if staff were not available.||units on a scale||Inter-Quartile Range|Median
662402|NCT01822821|Secondary|Postoperative Nausea and Vomiting|Incidence of any postoperative nausea and vomiting within 24 hours after surgery was collected.|End of surgery through 24 hours after surgery|||Participants|||Count of Participants
662403|NCT01822821|Primary|Pain Intensity|Evaluate the noninferiority and efficacy of IV acetaminophen; compared to a placebo, in reducing pain intensity scores after cardiac surgery. Pain scores were measured on the Numeric Rating scale, ranging from 0 to 10 (where 0 indicates no pain and 10 indicates the worst pain imaginable).|End of surgery through 24 hours after surgery|All patients had at least one postoperative pain scores. Some patients did not have a pain score at particular time points if they were unavailable (e.g., at a test), unable to speak (e.g., intubated), asleep, or similar reasons. We report any available pain scores at each time they were collected.||units on a scale||Standard Deviation|Mean
662404|NCT01822821|Primary|Cumulative Opioid Consumption|Evaluate the noninferiority and efficacy of IV acetaminophen; compared to a placebo, in reducing opioid consumption a after cardiac surgery. Total opioid consumption is defined as the total amount amount of opioids administered to patients converted to mg morphine equivalents.|End of surgery through 24 hours after surgery|||mg morphine equivalents||Inter-Quartile Range|Median
662405|NCT01822756|Secondary|Duration of Response|Duration of response was the time from the first overall response contributing to an objective response to the first overall response of progressive disease (PD) occurring after the first overall response contributing to the objective response. Confidence intervals for median duration of response were calculated using the method of Brookmeyer and Crowley (1982).|Randomization to clinical cutoff 22Sept2015 (approx 244 days)|Intent-to-Treat Population (ITT) population - All subjects who received at least 1 dose of RUX||days||Full Range|Median
662406|NCT01822756|Secondary|Percentage of Responders|Duration of response was measured as the time from the first overall response contributing to an objective response to the first overall response of progressive disease (PD) occurring after the first overall response contributing to the objective response.|Randomization to clinical cutoff 22Sept2015 (approx 244 days)|Intent-to-Treat Population (ITT) population - All subjects who received at least 1 dose of RUX||Percentage of responders|||Number
663883|NCT01796548|Secondary|Reflex Volume|Reflex volume is the infused volume that induces the first detrusor contraction.|Baseline and Week 12|Data for this outcome measure is not reported because the data was not collected and included in Case Report Form (CRF).|||||
662407|NCT01822756|Secondary|Percentage of Participants With a Best Response by RECIST Criteria|"Best response was determined on the subject level using the highest overall response achieved post-baseline. In the case of stable disease (SD), measurements had to meet the SD criterion at least once after study entry at a minimum interval of 49 days. Subjects who failed to meet this criterion had best response of progressive disease (PD) if the next available RECIST evaluation after the initial scan indicated PD or not evaluable (NE) if no additional RECIST evaluations were available.
Complete Response (CR) and Partial Response (PR) defined by the Response Evaluation Criteria in Solid Tumor (RECIST) criteria. CR: Disappearance of all target and nontarget lesions. PR: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter, or persistence of 1 or more nontarget lesion(s) or/and maintenance of tumor marker level above the normal limits."|every 2 cycles starting at Cycle 3 Day 1 up to approximately 4 to 6 months|Intent-to-Treat (ITT) Population - All subjects who received at least 1 dose of RUX||percentage of participants|||Number
662408|NCT01822756|Secondary|Clinical Activity as Measured by the Greatest Decrease in Tumor Burden Compared to Baseline.||Approximately 6 months|Enrollment of additional study cohorts was stopped after Cohort B1, RUX 10 mg BID-GCSF; Part 2 of the study was not conducted. Because of the early study termination, samples for pharmacokinetics and pharmacodynamics, and computed tomography for tumor burden were collected, but not analyzed; analysis data are not available.|||||
662409|NCT01822756|Secondary|Plasma Concentration of Tumor Specific Biomarkers and Cytokines Before and During Treatment.||Up to 6 months|Enrollment of additional study cohorts was stopped after Cohort B1, RUX 10 mg BID-GCSF; Part 2 of the study was not conducted.Because of the early study termination, samples for pharmacokinetics and pharmacodynamics, and computed tomography for tumor burden were collected, but not analyzed; analysis data are not available.|||||
662410|NCT01822756|Secondary|Plasma Concentrations Will be Used to Estimate Peak Plasma Concentration (Cmax) and Area Under the Plasma Concentration Curve (AUC).||Day 1 and Day 8|Further enrollment of additional study cohorts was stopped after Cohort B1, RUX 10 mg BID – GCSF; Part 2 of the study was not conducted. Because of the early study termination, samples for pharmacokinetics and pharmacodynamics, and computed tomography for tumor burden were collected, but not analyzed; analysis data are not available.|||||
662411|NCT01822756|Primary|Percentage of Participants With Adverse Events That Are Defined as Dose Limiting Toxicities (DLTs)|Toxicities occurring during the first treatment cycle (Cycle 1) defined tolerability. Within each cohort, subjects were considered evaluable if they had received at least 40 of 56 planned doses of RUX during the 28-day surveillance period and received 2 of the 3 planned doses of chemotherapy (gemcitabine and/or gemcitabine and nab-paclitaxel) at the assigned dose level, or they had experienced a DLT.|Approximately 28 days|Safety population included all enrolled subjects who received at least 1 dose of RUX.||percentage of participants|||Number
662412|NCT01822691|Secondary|Number of Participants With Study Treatment Related Adverse Events (AEs)|Participants with treatment emergent Other (not including serious) Adverse events.|Up to 12 months|All participants||participants|||Number
662413|NCT01822691|Secondary|Number of Participants With Study Related Serious Adverse Events (SAEs)|Participants with treatment emergent Grade 3 or 4 SAEs according to the NCI Common Terminology Criteria for Adverse Events Version (CTCAE) V4.0.|Up to 12 months|All participants||participants|||Number
662414|NCT01822691|Secondary|Median Overall Survival (OS)|Overall Survival (OS) defined as the time between the start of treatment and death. Treatment Duration is 17 weeks plus optional continuation phase. Study Duration is Treatment Phase followed by survival follow-up.|Up to 24 months|All participants||months||Full Range|Median
662415|NCT01822691|Secondary|Mean Time to Acute Myeloid Leukemia (AML) Progression|Disease progression defined as progression to int-2 or high risk International Prognostic Scoring System (IPSS) score or AML, based on World Health Organization (WHO) AML Criteria.|Up to 12 months|All participants||months||Full Range|Mean
662416|NCT01822691|Primary|Overall Response Rate (ORR)|ORR, measured by Response Criteria for Patients with Myelodysplastic Syndrome (MDS). According International Working Group (IWG) 2006 criteria (Cheson et al, 2006). Complete Remission (CR), Partial Remission (PR), Marrow CR, and Hematological Improvement (HI)(any cell line). Stable Disease (SD): Failure to achieve at least PR, but no evidence of progression for > 8 weeks.|Up to 12 months|All participants||participants|||Number
662417|NCT01822678|Primary|Change in the Young Mania Rating Scale (YMRS) Total Score at the End of the 3-week Treatment Period, in Relation to the Baseline.|The YMRS is used to assess disease severity in patients who have been previously diagnosed with mania and it has proven psychometric properties through 11 item multiple-choice diagnostic questionnaire and the total score is determined from the summation of each 11 individual scores (and can range from 0 – 60) based on the patient’s subjective feedback of his clinical condition over the previous 48 hours. A higher score indicates a worse rating for symptoms related to mania. At every visit throughout the study, investigators administered the YMRS. The results of the primary analysis of efficacy were calculated using Analysis of covariance (ANCOVA) with Last Observation Carried Forward (LOCF). Primary variable is presented through ANCOVA results for absolute change in YMRS total score from baseline (V2) to end of treatment (V7). A responder has at least 50% improvement (reduction) in the YMRS total score or has a total score of less than 12 points at the end of treatment period.|baseline and 3-week|The ITT efficacy population consisted of all randomised patients who received at least one dose of investigational product and at least 1 post-baseline YMRS assessment. If a patient discontinues before the end of the 3-week treatment period then the last observation will be carried forward (LOCF).||units on a scale||Standard Error|Least Squares Mean
662418|NCT01822665|Secondary|Incidence of Fecal Occult Blood|The incidence of fecal occult blood was recorded as a binary response (0 = no presence of blood; 1 = presence of blood).|Day 7|ITT population: All participants who fulfilled all the study entry criteria and received at least one of the study treatments. The ITT population included all participants with valid data-period. Missing data was not imputed.||Participants|||Number
662419|NCT01822665|Secondary|Incidence of Gastric and/or Duodenal Mucosal Injury|Number of participants with endoscopy score equal to or more than 2 were determined based on Lanza score for both gastric and duodenal mucosal damage.|Day 7|ITT population: All participants who fulfilled all the study entry criteria and receive at least one of the study treatments. The ITT population included all participants with valid data-period. Missing data was not imputed.||Participants|||Number
663945|NCT01794000|Secondary|Time to First Transient Ischemic Attack (TIA)/Ischemic Stroke||Randomization through 24 Months|No participants had a TIA or ischemic stroke at time of analysis.|||||
662420|NCT01822665|Secondary|Duodenal Mucosal Damage (DMD) Scores|DMD was measured using a 5- point Lanza scale: 0 - normal duodenum; 1 - mucosal hemorrhages; 2 - one or two erosions; 3 - numerous areas of erosions and 4 - more than 10 erosions/ ulcers.|Day 7|ITT population: All participants who fulfilled all the study entry criteria and receive at least one of the study treatments. The ITT population included all participants with valid data-period. Missing data was not imputed.||Score on a scale||Standard Deviation|Mean
662421|NCT01822665|Secondary|GMD Scores of Paracetamol Tablet; Ibuprofen Capsule; Ibuprofen Tablet; and Placebo Tablet|Endoscopic examination of the upper gastrointestinal mucosa evaluated the extent of mucosal injury to the stomach and the duodenum separately using a 5-point Lanza scale, ranging from 0: normal stomach; 1: mucosal hemorrhages; 2: one or two erosions; 3: numerous areas of erosions; and 4: more than 10 erosions or ulcer.|Day 7|ITT population: All participants who fulfilled all the study entry criteria and received at least one of the study treatments. The ITT population included all participants with valid data-period. Missing data was not imputed.||Score on a scale||Standard Deviation|Mean
662422|NCT01822665|Primary|Gastromucosal Damage (GMD) Score of Paracetamol Tablet vs Ibuprofen Capsule|Endoscopic examination of the upper gastrointestinal mucosa evaluated the extent of mucosal injury to the stomach and the duodenum separately using a 5-point Lanza scale, ranging from 0: normal stomach; 1: mucosal hemorrhages; 2: one or two erosions; 3: numerous areas of erosions; and 4: more than 10 erosions or ulcer.|Day 7|Intent to Treat (ITT) population: all participants who fulfilled all the study entry criteria and receive at least one of the study treatments. The ITT population included all participants with valid data-period. Missing data was not imputed.||Scores on a scale||Standard Deviation|Mean
662423|NCT01822574|Secondary|Time to Complete Patella Resurfacing|Each patellar resection procedure began by exposing the articular surface of the patella. Once the patella was fully exposed and the surgeon measured the native patellar thickness, the timer was started. After the final resection, the timer was stopped.|Time 0 (prior to patella resection), and after surgery (approximately 3 hours)|||seconds||Standard Deviation|Mean
662424|NCT01822574|Secondary|The Difference Between Surgeon Goal and Actual Resection Height|This outcome measure attempts to capture the most accurate method for obtaining a desired thickness. Each patellar resection procedure began by exposing the articular surface of the patella. Once the patella was fully exposed and the surgeon measured the native patellar thickness, the timer was started. The surgeon then stated their goal for post resection thickness, and these values were recorded. After the final resection, the timer was stopped. The ability to obtain the resection goal was independently assessed by a resident or fellow not involved in the resection. This was calculated by taking the difference between the surgeon's goal and the average thickness of the four quadrants measured by the resident or fellow.|Time 0 (prior to patella resection), and after surgery (approximately 3 hours)|||mm||Standard Deviation|Mean
662425|NCT01822574|Primary|Mean Asymmetry of the Patella After Patella Resection|"Post-resection symmetry of the patella was independently assessed by a resident or fellow who was not involved in the resection. This was evaluated by dividing the patella into four equal quadrants and measuring the thickness in the center of each quadrant using a ring tipped or C-shaped caliper. The difference between the thickest and thinnest measurements of the patella was reported as the value of asymmetry."|approximate average surgery time of 3 hours|||mm||Standard Deviation|Mean
662426|NCT01822548|Secondary|Absolute Change in HbA1C Compared to Baseline|The secondary endpoint was the change from baseline values of HbA1C in the Vildagliptin vs Glibenclamide arm at 4 and 12 months|V0 (randomization), V2 (month4), V4 (month 12).|||percentage||Inter-Quartile Range|Median
662427|NCT01822548|Primary|Absolute Change in the Endothelial Progenitor Cell (EPC) Number|The study primary endpoint was the change from baseline values of the EPC number in the Vildagliptin vs Glibenclamide arm at 4 and 12 months.|V0, V2 (month 4), V4 (12 month)|Intention to treat (ITT) analysis||EPC/10^6 cells||Inter-Quartile Range|Median
662428|NCT01822535|Primary|Visit 2: Percent Change in Core Body Temperature With Midodrine|We will test the effects of midodrine on the ability to maintain a constant body temperature (e.g., core temperature of 98.6°F) after exposure to cool temperatures (64°F) in persons with tetraplegia through comparing the percent changes in core body temperature during visit 1 to percent changes in core body temperature during visit 2.|Baseline, Baseline Post-midodrine, Up to 2 hours|Subjects analyzed were individuals who completed visit 1 of testing.||Percent Change||Standard Deviation|Mean
662429|NCT01822535|Secondary|Visit 1: Percent Changes in Cognitive Performance - Delayed Recall|Cognitive performance will be evaluated using the Delayed Recall obtained using the Memory section of the Montreal Cognitive Assessment (MoCA). We will measure the change in cognitive performance in persons with tetraplegia after exposure to a cool environment (64°F) of up to 120 min in the seated position. Note: Scores are based on individual performance. All subjects are asked to remember two lists of five words (one list during baseline, and one list during cool Challenge). Lower scores indicate poorer performance, and a positive percent change in indicates improved cognitive performance.|Baseline, Up to 2 hours|Only the subjects with tetraplegia who demonstrated sympathetic interruption (insignificant decreases in distal skin temperatures, distal microvascular blood flow (LDF) and decreases of 1.0°C or greater in Tcore during cool exposure), and their matched able-bodied controls were analyzed.||Percent Change||Standard Deviation|Mean
662430|NCT01822535|Secondary|Visit 1: Percent Changes in Cognitive Performance - Stroop Interference|Cognitive performance will be evaluated using the Interference T-Scores obtained using the Stroop Color and Word Test. We will measure the change in cognitive performance in persons with tetraplegia after exposure to a cool environment (64°F) of up to 120 min in the seated position. Note: Interference T-Scores are derived from the difference between the raw Color-Word score and the projected Color-Word score (which is, in turn, based on the raw scores obtained in the Word and Color portions of the Test). Lower scores indicate poorer performance, and a positive percent change in T-scores indicates improved performance.|Baseline, Up to 2 hours|Only the subjects with tetraplegia who demonstrated sympathetic interruption (insignificant decreases in distal skin temperatures, distal microvascular blood flow (LDF) and decreases of 1.0°C or greater in Tcore during cool exposure), and their matched able-bodied controls were analyzed.||Percent Change||Standard Deviation|Mean
662521|NCT01820364|Secondary|Incidence of Dose Limiting Toxicities (DLTs) (Part II)|Incidence of DLTs in Part II of the study was not evaluated due to an inadequate number of patients enrolled in Part II prior to the permanent recruitment halt of this study.|Baseline through study completion (approximately 2 years)||||||
662431|NCT01822535|Primary|Visit 1: Percent Change in Core Body Temperature|We will test the effects of cool temperature (64°F) exposure, of up to 120 minutes, on the ability to maintain a constant body temperature (e.g., core temperature of 98.6°F) in persons with tetraplegia through comparing the percent changes in core body temperatures between groups from baseline to after cool exposure.|Baseline, Up to 2 hours|Only the subjects with tetraplegia who demonstrated sympathetic interruption (insignificant decreases in distal skin temperatures, distal microvascular blood flow (LDF) and decreases of 1.0°C or greater in Tcore during cool exposure), and their matched able-bodied controls were analyzed.||Percent Change||Standard Deviation|Mean
662432|NCT01822301|Secondary|Serial Computed Tomography Imaging|serial computed tomography images were collected to evaluate the volume of the defect|assessed at 7-21 days, 3 months and 9 months post op.|||volume, mL||Standard Deviation|Mean
662433|NCT01822301|Primary|Facial Volume Score|the facial volume and appearance grading scale evaluates each aesthetic region in the face based on both physical examination and 3D photography by the clinician. scale ranges from 1-3 where a score of 1 indicates an obvious contour defect; 2 shows a noticeable improvement in contour but not sufficient to impart a normal appearance; 3 represents a normal appearance and/or close approximation with a normal uninjured contralateral structure.|assessed at baseline (pre-op), days 7-21 post-op, 3 months post-op, and 9 months post-op|||units on a scale||Standard Deviation|Mean
662434|NCT01822223|Secondary|Mean Change in Millimeters of Clinical Attachment to the Abutment|A periodontal probe will be used to measure the level of clinical attachment to the abutment in millimeters. Measurements will be captured at 4 points around each abutment; mesial, buccal, distal, and lingual. All measurements were considered and the change in attachment level was assessed at each individual site. Data were reported as descriptive and were used to elucidate potential advantages and/or disadvantages of varying abutment types. These data were strictly confirmatory to the proof-in-principle histology presented in the report. Measures were taken at 8 weeks, 12 weeks, 16 weeks and 12 months to determine if attachment to one abutment type was more or less stable over time. The specific force probe generates a descriptive graph that demonstrates the cumulative force and distribution necessary to disrupt the attachment of the gingival tissues to the abutment. These graphs were recorded, but were difficult to interpret and have not been reported.|12 month post-abutment placement|No data was collected on subjects from the mesial, buccal, distal or lingual sites as sites were not assessed on subjects for reasons unknown.|||||
662435|NCT01822223|Secondary|Mean Change in Millimeters of Clinical Attachment to the Abutment|A periodontal probe will be used to measure the level of clinical attachment to the abutment in millimeters. Measurements will be captured at 4 points around each abutment; mesial, buccal, distal, and lingual. All measurements were considered and the change in attachment level was assessed at each individual site. Data were reported as descriptive and were used to elucidate potential advantages and/or disadvantages of varying abutment types. These data were strictly confirmatory to the proof-in-principle histology presented in the report. Measures were taken at 8 weeks, 12 weeks, 16 weeks and 12 months to determine if attachment to one abutment type was more or less stable over time. The specific force probe generates a descriptive graph that demonstrates the cumulative force and distribution necessary to disrupt the attachment of the gingival tissues to the abutment. These graphs were recorded, but were difficult to interpret and have not been reported.|16 weeks post-abutment placement|No data was collected on subjects from the mesial, buccal, distal or lingual sites as sites were not assessed on subjects for reasons unknown.|||||
662436|NCT01822223|Secondary|Mean Change in Millimeters of Clinical Attachment to the Abutment|A periodontal probe will be used to measure the level of clinical attachment to the abutment in millimeters. Measurements will be captured at 4 points around each abutment; mesial, buccal, distal, and lingual. All measurements were considered and the change in attachment level was assessed at each individual site. Data were reported as descriptive and were used to elucidate potential advantages and/or disadvantages of varying abutment types. These data were strictly confirmatory to the proof-in-principle histology presented in the report. Measures were taken at 8 weeks, 12 weeks, 16 weeks and 12 months to determine if attachment to one abutment type was more or less stable over time. The specific force probe generates a descriptive graph that demonstrates the cumulative force and distribution necessary to disrupt the attachment of the gingival tissues to the abutment. These graphs were recorded, but were difficult to interpret and have not been reported.|12 weeks post-abutment placement|No data was collected on subjects from the mesial, buccal, distal or lingual sites as sites were not assessed on subjects for reasons unknown.|||||
662437|NCT01822223|Secondary|Mean Change in Millimeters of Clinical Attachment to the Abutment|A periodontal probe will be used to measure the level of clinical attachment to the abutment in millimeters. Measurements will be captured at 4 points around each abutment; mesial, buccal, distal, and lingual. All measurements were considered and the change in attachment level was assessed at each individual site. Data were reported as descriptive and were used to elucidate potential advantages and/or disadvantages of varying abutment types. These data were strictly confirmatory to the proof-in-principle histology presented in the report. Measures were taken at 8 weeks, 12 weeks, 16 weeks and 12 months to determine if attachment to one abutment type was more or less stable over time. The specific force probe generates a descriptive graph that demonstrates the cumulative force and distribution necessary to disrupt the attachment of the gingival tissues to the abutment. These graphs were recorded, but were difficult to interpret and have not been reported.|8 weeks post-abutment placement|No data was collected on subjects from the mesial, buccal, distal or lingual sites as sites were not assessed on subjects for reasons unknown.|||||
662438|NCT01822223|Secondary|Grams of Force Needed to Disrupt Tissue Attachment to the Abutment|A force transducing periodontal probe instrument will electronically capture the grams of force needed to disrupt the attachment to the implant abutment; tissues will be probed from the gingival margin to the alveolar bone crest at 4 points around each abutment and an adjacent tooth: measurements will be captured from the mesial, buccal, distal, and lingual. The specific force probe generates a descriptive graph that demonstrates the cumulative force and distribution necessary to disrupt the attachment of the gingival tissues to the abutment. These graphs were recorded, but were difficult to interpret and have not been reported.|8 weeks post-abutment placement|No data was collected on subjects from the mesial, buccal, distal or lingual sites as sites were not assessed on subjects for reasons unknown.|||||
662439|NCT01822223|Primary|Number od Participants With Consistent Connective Tissue Integration at a Histologic Level|Connective tissue integration was assessed by radio graphic images of tissue and bone surrounding the implant.|8 weeks post-abutment placement|The number of participants entered represents measured data.||participants|||Number
662440|NCT01822197|Secondary|Quality of Life Scoring Post-Treatment (Day 7) and at Admission (Day 0|Quality of life scoring at admission (Day 0) and post-treatment (Day 7) using the CF questionnaire-revised (CFQ-R) as a measure of health related quality of life. Minimally important changes in CFQ-R scoring have been reported at 5–8. Days 0 and 7 will be compared. Score range is 0 to 100. Lower scores indicate worse quality of life.|between day 0 and day 7 of hospitalization|||units on a scale||Standard Deviation|Mean
662441|NCT01822197|Secondary|Depressive Symptom Scores Post-Treatment (Day 7) and at Admission (Day 0)|depressive symptom scoring at day 0 and day 7 using Quick Inventory of Depressive Symptomatology-clinician (QIDS-C) and Quick Inventory of Depressive Symptomatology self-report (QIDS-SR). Day 7 and Day 0 scores will be compared. Score range is 0 to 27. A QIDS score of less than 6 indicates no depression, 6–10 indicates mild depression, 11–15 moderate, 16–20 severe, and 21– 27 very severe depression.|between day 0 and day 7 of hospitalization|||units on a scale||Standard Deviation|Mean
662442|NCT01822197|Primary|Length of Hospitalization|Length of stay will be measured in days|participants will be followed for the length of hospital stay, an average of 14 days|||days||Standard Deviation|Mean
662443|NCT01822119|Other Pre-specified|Safety; Numbness|Evaluation of numbness by asking the patients if they had experienced any numbness within 2 cm from the centre of the implant magnet or within and beyond 2 cm from the centre of the implant magnet.|36 weeks|Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.||participants|||Number
662444|NCT01822119|Other Pre-specified|Safety; Pain|Evaluation of neuropathic pain or pain in the scar the last week by asking the patients to rate their experience on a scale from 1 (no, not at all) to 10 (yes, very much).|36 weeks|Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.||units on a scale||Standard Deviation|Mean
662445|NCT01822119|Other Pre-specified|Safety; Skin Evaluation|Evaluation of the skin using the Patient and Observer Scar Assessment Scale (POSASa scale from 1 (normal skin) to 10 (worst scar imaginable).|36 weeks|Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.||units on a scale||Standard Deviation|Mean
662446|NCT01822119|Other Pre-specified|Magnetic Force|To investigate if the magnetic force required for sound processor magnet retention will change over time|Week 4, 6, 12 and 36|Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.||Newton||Standard Deviation|Mean
662447|NCT01822119|Other Pre-specified|Feedback Measurement, BP110|Difference between softband measurement at visit 1 and measurement with the Baha Attract system at visit 6. Feedback is a measure of how much sound from the actuator (vibrator) returns to the microphones thus creating a loop of sound which sounds like high pitch noise. Measuring this is a part of the performance of the system, i.e how much gain can the sound processor produce before feedback occurs. Unit of measure is dB re output. A negative value of the change means less feedback.|Baseline before surgery and 12 weeks after surgery|Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.||dB||Standard Deviation|Mean
662448|NCT01822119|Other Pre-specified|Feedback Measurement, BP100|Difference between softband measurement at visit 1 and measurement with the Baha Attract system at visit 6. Feedback is a measure of how much sound from the actuator (vibrator) returns to the microphones thus creating a loop of sound which sounds like high pitch noise. Measuring this is a part of the performance of the system, i.e how much gain can the sound processor produce before feedback occurs. Unit of measure is dB re output. A negative value of the change means less feedback.|Baseline before surgery and 12 weeks after surgery|Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.||dB||Standard Deviation|Mean
662449|NCT01822119|Other Pre-specified|Choice of Sound Processor|Type of sound processors BP100 and BP110 attached to a soft band (subject preference)|Baseline|Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.||participants|||Number
662450|NCT01822119|Other Pre-specified|Implant Stability|Implant Stability Quotient - ISQ, a scale from 1 to 100, where 100 represent the highest stability.|Visit 2 (surgery)|Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.||units on a scale||Standard Deviation|Mean
662451|NCT01822119|Other Pre-specified|Tissue Reduction Performed During Surgery|Surgical thinning of the soft tissue flap was advocated when the soft tissue thickness exceeded 6 mm.|Visit 2 (surgery)|Intention-to-Treat population, includes all patients who received surgical intervention.||participants|||Number
662452|NCT01822119|Other Pre-specified|Time to Perform Surgery||Visit 2 (surgery)|Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.||minutes||Standard Deviation|Mean
662453|NCT01822119|Secondary|Abbreviated Profile of Hearing Aid Benefit (APHAB)|Change of APHAB scoring from the unaided pre-operative situation to the aided situation with Baha Attract at 36 weeks. APHAB questionnaire is a 24-item self-assessment inventory that evaluates the benefit experienced by the patient when using hearing amplification compared to the unaided situation. APHAB produces a Global score and scores for four subscales: ease of communication (EC), reverberation (RV), background noise (BN), and aversiveness (AV). The absolute APHAB scale is between 0 and 100%, where 0% indicates no problem and 100% indicates always problem. The change from unaided to aided hearing is presented. A positive value indicates an improvement, a negative value an impairment. This scale applies to all reported scores.|Baseline before surgery and 36 weeks after surgery|Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.||units on a scale||Standard Deviation|Mean
662454|NCT01822119|Secondary|Hearing Performance, Speech in Noise, Aided With the Sound Processor on a Softband Versus Baha Attract at 36 Weeks|The change in hearing performance, speech in noise from the pre-operative aided situation with the Sond Processor on a softband to the aided situation with the Baha Attract System at week 36.|Baseline before surgery and 36 weeks after surgery|Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.||Signal to noise ratio||Standard Deviation|Mean
662455|NCT01822119|Secondary|Hearing Performance, Speech in Noise, Unaided Versus Baha Attract at 36 Weeks|The change in hearing performance, speech in noise from the pre-operative unaided condition to the aided situation with the Baha Attract System at week 36.|Baseline before surgery and 36 weeks after surgery|Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.||Signal to noise ratio||Standard Deviation|Mean
663978|NCT01792986|Secondary|Difference in Human Growth Hormone (HGH) Between Baseline and the End of the Sixth Week.||6 weeks|||ng/mL||Standard Deviation|Mean
662456|NCT01822119|Secondary|Hearing Performance, Speech in Quiet, Aided With the Sound Processor on a Softband Versus Baha Attract at 36 Weeks|The change in hearing performance, speech in quiet from the pre-operative aided situation with the Sond Processor on a softband to the aided situation with the Baha Attract System at week 36.|Baseline before surgery and 36 weeks after surgery|Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.||% perception of presented words||Standard Deviation|Mean
662457|NCT01822119|Secondary|Hearing Performance, Speech in Quiet, Unaided Versus Baha Attract at 36 Weeks|The change in hearing performance, speech in quiet from the pre-operative unaided condition to the aided situation with the Baha Attract System at week 36.|Baseline before surgery and 36 weeks after surgery|Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.||% perception of presented words||Standard Deviation|Mean
662458|NCT01822119|Secondary|Hearing Performance, Individual Frequencies, Sound Processor on Softband Versus Baha Attract at 36 Weeks|The change in pure-tone thresholds in free field measured by the difference in hearing levels of individual frequencies from the pre-operative aided situation with the Sound Processor on a softband to the aided situation with Baha Attract System at week 36.|Baseline before surgery and 36 weeks after surgery|Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.||dB||Standard Deviation|Mean
662459|NCT01822119|Secondary|Hearing Performance, PTA4, Sound Processor on Softband Versus Baha Attract at 36 Weeks|The change in pure-tone thresholds in free field measured by the difference in pure tone average PTA4 (Mean of thresholds at 500, 1000, 2000 and 4000 Hz) from the pre-operative aided situation with the Sound Processor on a softband to the aided situation with Baha Attract System at week 36.|Baseline before surgery and 36 weeks after surgery|Intention-to-Treat population, includes all patients who received surgical intervention.||dB||Standard Deviation|Mean
662460|NCT01822119|Secondary|Hearing Performance, Individual Frequencies|The change in pure-tone thresholds in free field measured by the difference at individual frequencies from the pre-operative unaided condition to the aided situation with the Baha Attract System at week 36.|Baseline before surgery and 36 weeks after surgery|Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.||dB||Standard Deviation|Mean
662461|NCT01822119|Primary|Hearing Performance, PTA4 at 36 Weeks|The change in pure-tone thresholds in free field measured by the difference in pure tone average PTA4 (Mean of thresholds at 500, 1000, 2000 and 4000 Hz) from the pre-operative unaided condition to the aided situation with the Baha Attract System at week 36.|Baseline before surgery and 36 weeks after surgery|||dB||Standard Deviation|Mean
662462|NCT01822119|Primary|Hearing Performance, PTA4 at 12 Weeks|The change in pure-tone thresholds in free field measured by the difference in pure tone average PTA4 (Mean of thresholds at 500, 1000, 2000 and 4000 Hz) from the pre-operative unaided condition to the aided situation with the Baha Attract System at week 12.|Baseline before surgery and 12 weeks after surgery|Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.||dB||Standard Deviation|Mean
662463|NCT01821963|Secondary|Sustained Virological Response (SVR)|Sustained virological response (SVR) defined as a single undetectable HCV-RNA measurement 12 weeks after the 48-week treatment period for those still waiting for transplantation. The treatment duration will be summarized with descriptive statistics. Additional analyses based on evaluable patients also conducted regarding the PTVR response rate. The evaluable patients are defined as those patients who complete at least 16 weeks of treatment and have the 12 weeks post-transplant response measurement. The rate will also be computed stratified by the HCV treatment time (i.e., the 48-week HCV treatment versus less than 48 week HCV treatment) considering the different times under HCV. The SVR rate will be estimated, along with the exact 95% confident interval.|60 weeks||||||
662464|NCT01821963|Primary|Number of Participants With Undetectable Viral Load 12 Weeks Post-transplant|"The primary endpoint is number of participants with undetectable viral load at 12 weeks post-transplant (Post-transplant virological response, (PTVR)) which is defined as undetectable Hepatitis C Virus ribonucleic acid (HCV-RNA) 12 weeks after liver transplantation). In order to have undetectable HCV RNA viral load after transplant, participants need to have undetectable viral load before the liver transplant.
Response rate based on the modified intent-to-treat (ITT) population where ITT population is defined as those patients who have achieved an undetectable HCV-RNA level before the transplant. If patients drop out the study early due to severe toxicity or treatment failure including treatment-related death, they will be counted as non-responders when evaluating the response rate."|12 weeks post-transplant, up to 48 weeks for overall monitoring|Study terminated early with one participant. No analysis possible.|||||
662465|NCT01821937|Secondary|Tmax,ss (After Multiple Dosing)|tmax,ss is defined as the time from last dosing to the maximum measured concentration of Faldaprevir in plasma at steady state|Before drug administration and 24 hours(h), 48,72,96,120,144,168,192,216,216.5,217,218,219,220,222,224,228, 240 h after first administration of Faldaprevir|Pharmacokinetic analysis set (PKS): This set included all subjects in TS who provided at least one PK endpoint and had no important protocol violations relevant to the evaluation of PK and provided no emesis with onset at or before twice the median t max .||hour||Geometric Coefficient of Variation|Geometric Mean
662466|NCT01821937|Secondary|t(1/2,ss) (After Multiple Dosing)|t(1/2,ss) is defined as the terminal half-life of Faldaprevir in plasma at steady state.|Before drug administration and 24 hours(h), 48,72,96,120,144,168,192,216,216.5,217,218,219,220,222,224,228,240 h after first administration of Faldaprevir|Pharmacokinetic analysis set (PKS): This set included all subjects in TS who provided at least one PK endpoint and had no important protocol violations relevant to the evaluation of PK and provided no emesis with onset at or before twice the median t max .||hour||Geometric Coefficient of Variation|Geometric Mean
662467|NCT01821937|Secondary|AUC(0-tz) (After Single Dosing)|AUC (0-tz) is defined as area under the concentration-time curve of the analyte in plasma over the respective time interval, where t and z define beginning and end times of the time interval.|Before drug administration and 0.5 hours(h), 1,1.5,2,3,4,6,8,12,24,48,72,96h after administration of Faldaprevir|Pharmacokinetic analysis set (PKS): This set included all subjects in TS who provided at least one PK endpoint and had no important protocol violations relevant to the evaluation of PK and provided no emesis with onset at or before twice the median t max .||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
663216|NCT01808209|Secondary|Conjunctival Staining|Assessment of ocular health. Collected at 1 week after removal of lenses. (Biomicroscopy, 0-4, 0=none , 4=severe )|1 Week|All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.||units on a scale|Participants|Standard Deviation|Mean
662468|NCT01821937|Secondary|Cmax (After Single Dosing)|Cmax is defined as maximum measured concentration of Faldaprevir in plasma.|Before drug administration and 0.5 hours(h), 1,1.5,2,3,4,6,8,12,24,48,72,96h after administration of Faldaprevir|Pharmacokinetic analysis set (PKS): This set included all subjects in TS who provided at least one PK endpoint and had no important protocol violations relevant to the evaluation of PK and provided no emesis with onset at or before twice the median t max .||ng/mL||Geometric Coefficient of Variation|Geometric Mean
662469|NCT01821937|Primary|AUC(Tau,ss) (After Multiple Dosing)|AUC(tau,ss) is defined as area under the concentration-time curve of Faldaprevir in plasma at steady state over a uniform dosing interval tau.|Before drug administration and 24 hours(h), 48,72,96,120,144,168,192,216,216.5,217,218,219,220,222,224,228,240 h after first administration of Faldaprevir|Pharmacokinetic analysis set (PKS): This set included all subjects in TS who provided at least one PK endpoint and had no important protocol violations relevant to the evaluation of PK and provided no emesis with onset at or before twice the median t max .||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
662470|NCT01821937|Primary|Cmax,ss (After Multiple Dosing)|C(max,ss) is defined as maximum measured concentration of Faldaprevir in plasma at steady state over a uniform dosing interval tau.|Before drug administration and 24 hours(h), 48,72,96,120,144,168,192,216,216.5,217,218,219,220,222,224,228, 240 h after first administration of Faldaprevir|Pharmacokinetic analysis set (PKS): This set included all subjects in TS who provided at least one Pharmacokinetic (PK) endpoint and had no important protocol violations relevant to the evaluation of PK and provided no emesis with onset at or before twice the median t max .||ng/mL||Geometric Coefficient of Variation|Geometric Mean
662471|NCT01821859|Primary|Number of Participants With Progression Free Survival Rate at 6 Months as Defined as Complete Response, Partial Response, or Stable Disease.|Using RECIST criteria, Complete Response (CR)= disappearance of all target lesions, Partial Response (PR)= At least a 30% decrease in the sum of the longest diameter of target lesions, and Stable Disease (SD)= neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify as progressive disease.|6 months after start of dosing||||||
662472|NCT01821807|Secondary|Backache in Patients Receiving Spinal Anesthesia for Cesarean Section|Patients were observer for the symptoms of postdural puncture backache for 1 week. On the 1st postoperative day they were visited in the clinic. On the 7th postoperative day they were contacted by telephone and were asked about the symptoms.|1 week|||participants|||Number
662473|NCT01821807|Primary|Postdural Puncture Headache in Patients Receiving Spinal Anesthesia for Cesarean Section|Patients were observer for the symptoms of headache (PDPH) for 1 week. On the 1st postoperative day they were visited in the clinic. On the 7th postoperative day they were contacted by telephone and were asked about the symptoms.|1 week|||participants|||Number
662474|NCT01821534|Primary|Intra-rater Reliability Using a LFSC|The LFSC is a qualitative tool to assess facial shape into one of 5 categories (A, B, C, D, and E). Intra-rater (within raters) reliability was calculated using Kappa statistics. Kappa statistics were calculated for each of the 8 physician raters. The overall intra-rater agreement for Kappa statistics for all raters combined was estimated by pooling Kappa statistics for each rater using a chi-square statistic. The degree of agreement of the point estimates of Kappa statistics was interpreted according to the reference range scale that was pre-defined as: ≤0: poor, >0 to ≤0.2: slight, >0.2 to ≤0.4: fair, >0.4 to ≤0.6: moderate, >0.6 to ≤0.8: substantial, and >0.8 to ≤1.0: almost perfect. The 95% confidence interval for Kappa statistics is provided.|Day 1|Reliability population: all subjects with at least assessment 1 performed by at least 1 in-person rater on day 1||Kappa statistics||95% Confidence Interval|Number
662475|NCT01821534|Primary|Inter-rater Reliability Using a Lower Facial Shape Classification (LFSC)|The LFSC is a qualitative tool to assess facial shape into one of 5 categories (A, B, C, D, and E). Inter-rater (among raters) reliability was calculated using Kappa statistics. Kappa statistics were calculated for each of the 5 facial categories. A total of 8 physicians rated each subject. The overall inter-rater agreement for Kappa statistics for all categories combined was estimated by pooling Kappa statistics for each category using a chi-square statistic. The degree of agreement of the point estimates of Kappa statistics was interpreted according to the reference range scale that was pre-defined as: ≤0: poor, >0 to ≤0.2: slight, >0.2 to ≤0.4: fair, >0.4 to ≤0.6: moderate, >0.6 to ≤0.8: substantial, and >0.8 to ≤1.0: almost perfect. The 95% confidence interval for Kappa statistics is provided.|Day 1|Reliability population: all subjects with at least assessment 1 performed by at least 1 in-person rater on day 1||Kappa Statistics||95% Confidence Interval|Number
662476|NCT01821534|Primary|Intra-rater Reliability Using a MMPS|The MMPS is an ordinal tool to assess the masseter muscle prominence (jaw muscle) for each side of the face from 1 = minimal to 5 = very marked. Intra-rater (within raters) reliability was calculated separately for the left and right side of the face using weighted Kappa statistics. Weighted Kappa statistics were calculated for each of the 8 physician raters. The overall intra-rater agreement for Kappa statistics for all raters combined was estimated by pooling Kappa statistics for each rater using a chi-square statistic. The degree of agreement of the point estimates of Kappa statistics was interpreted according to the reference range scale that was pre-defined as: ≤0: poor, >0 to ≤0.2: slight, >0.2 to ≤0.4: fair, >0.4 to ≤0.6: moderate, >0.6 to ≤0.8: substantial, and >0.8 to ≤1.0: almost perfect. The 95% confidence interval for Kappa statistics is provided.|Day 1|Reliability population: all subjects with at least assessment 1 performed by at least 1 in-person rater on day 1||Kappa statistics||95% Confidence Interval|Number
662477|NCT01821534|Primary|Inter-rater Reliability Using a Masseter Muscle Prominence Scale (MMPS)|The MMPS is an ordinal tool to assess the masseter muscle prominence (jaw muscle) for each side of the face from 1=minimal to 5=very marked. Inter-rater (among raters) reliability was calculated separately for the left and right side of the face using Kendall’s coefficient of concordance (Kendall's W). Kendall W statistics overall for the left and right sides of the face were derived using the average of assessment 1 and assessment 2 rounded to the nearest whole integer for each subject and each clinician. A total of 8 physicians rated each subject. The degree of agreement of the point estimates of Kendall's W was interpreted according to the reference range scale that was pre-defined as: ≤0: poor, >0 to ≤0.2: slight, >0.2 to ≤0.4: fair, >0.4 to ≤0.6: moderate, >0.6 to ≤0.8: substantial, and >0.8 to ≤1.0: almost perfect. The 95% confidence interval for Kendall's W is provided.|Day 1|Reliability population: all subjects with at least assessment 1 performed by at least 1 in-person rater on day 1||Kendall's W||95% Confidence Interval|Number
663217|NCT01808209|Secondary|Corneal Staining|Assessment of ocular health. Collected at 1 week after removal of lenses. (Biomicroscopy, 0-4, 0=none , 4=severe )|1 Week|||units on a scale|Participants|Standard Deviation|Mean
662481|NCT01821378|Secondary|Change From Baseline to Week 6 for the ENR Lurasidone 80mg and ENR Lurasidone 160mg Groups vs the Placebo in the CGI-S Score|"The CGI-S is a clinician-rated assessment of the subject’s current illness state on a 7-point scale, where a higher score is associated with greater illness severity. Following a clinical interview, the CGI-S can be completed in 1-2 minutes.
Reason for the discrepancy of the LS mean (SE) for placebo in outcome 2 and outcome 9 is because the different MMRM model used in outcome 2 and outcome 9. The treatment groups included in the MMRM model for outcome 2 are placebo, lurasidone 20 mg, and lurasidone 80-160 mg. The treatment groups included in the MMRM model for outcome 9 are placebo, ENR lurasidone 80 mg, and ENR lurasidone 160 mg."|baseline to week 6|ENR (early non-responders) Intent to treat (ITT) population: of the 199 subjects who randomized to 80 mg group, only 95 subjects are early non-responders at week 2, therefore they are included in the ENR ITT population (Lurasidone 20 mg subjects are not included in the ENR ITT population).||units on a scale||Standard Error|Least Squares Mean
662482|NCT01821378|Secondary|Change From Baseline to Week 6 for the ENR Lurasidone 80mg and ENR Lurasidone 160mg Groups vs the Placebo in the PANSS Total Score|The PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity.|Baseline to week 6|ENR (early non-responders) Intent to treat (ITT) population: of the 199 subjects who randomized to 80 mg group, only 95 subjects are early non-responders at week 2, therefore they are included in the ENR ITT population (Lurasidone 20 mg subjects are not included in the ENR ITT population).||units on a scale||Standard Error|Least Squares Mean
662483|NCT01821378|Other Pre-specified|Change From Baseline to Week 6 for the Lurasidone 20 mg and Lurasidone 80 - 160 mg Groups Compared to the Placebo Group in the Euroqol (EQ-5D) Index Score|The EQ-5D is a standardized measure of health state consisting of two parts: a) EQ-5D measuring mobility, self-care, pain/discomfort, usual activities, and anxiety/depression on a 0 2 scale with lower scores indicating improvement, and b) a 20-cm visual analogue scale (VAS) for health status rating on a 0-100 scale with higher scores indicating improvement. EQ-5D health states, defined by the EQ-5D descriptive system, may be converted into a single summary index (i.e. the EQ-5D index score) by applying a formula that essentially attaches values (also called weights) to each of the levels in each dimension. The EQ-5D Index scores ranged from -0.429 to 1.000. Generally higher observed EQ-5D Index scores indicate a better degree of health.|6 weeks|Intent to treat population: there are only 368 subjects who had at least one post-baseline Euroqol (EQ-5D) assessments.||units on a scale||Standard Error|Least Squares Mean
662484|NCT01821378|Secondary|Change From Week 2 to Week 6 for ENR Lurasidone 80 mg vs. ENR Lurasidone 160 mg in CGI-S Score|The CGI-S is a clinician-rated assessment of the subject’s current illness state on a 7-point scale (0-7), where a higher score is associated with greater illness severity. Following a clinical interview, the CGI-S can be completed in 1-2 minutes.|week 2 to week 6|ENR Intent to treat population||units on a scale||Standard Error|Least Squares Mean
662485|NCT01821378|Other Pre-specified|Change From Baseline to Week 6 for the Lurasidone 20 mg and Lurasidone 80 - 160 mg Groups Compared to the Placebo Group in the GAF Score|The GAF is a numeric scale (0 through 100) that measures a patient’s overall level of psychological, social, and occupation functioning. It is designed to guide clinicians through a methodical and comprehensive consideration of all aspects of a patient’s symptoms and functioning. The scale begins at 100 - superior functioning - to 0 - inadequate information.|6 Weeks|Intent to treat population||units on a scale||Standard Error|Least Squares Mean
662486|NCT01821378|Secondary|Change From Baseline to Week 6 for the ENR Lurasidone 80mg and ENR Lurasidone 160mg Groups vs the Placebo in the MADRS Total Score|"The MADRS consists of 10 items, each rated on a Likert scale, from 0=Normal to 6=Most Severe. The MADRS total score is calculated as the sum of the 10 items. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity."|baseline to week 6|ENR (early non-responders) Intent to treat (ITT) population: of the 199 subjects who randomized to 80 mg group, only 95 subjects are early non-responders at week 2, therefore they are included in the ENR ITT population (Lurasidone 20 mg subjects are not included in the ENR ITT population).||units on a scale||Standard Error|Least Squares Mean
662487|NCT01821378|Secondary|Change From Week 2 to Week 6 for the ENR (Early Non-responders) Lurasidone 160mg Group vs the ENR (Early Non-responders) Lurasidone 80 mg Group in the Following: PANSS Total Score|The PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity.|week 2 to week 6|ENR (early non-responders) Intent to treat (ITT) population: of the 199 subjects who randomized to 80 mg group, only 95 subjects are early non-responders at week 2, therefore they are included in the ENR ITT population.||units on a scale||Standard Error|Least Squares Mean
662488|NCT01821378|Secondary|Proportion of Subjects Who Achieve a Response, Defined as 20% or Greater Improvement From Baseline in Positive and Negative Syndrome Score (PANSS) Total Score at Week 6|The PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity.|6 Weeks|Intent to treat population||percentage of participants|||Number
662489|NCT01821378|Secondary|Change From Baseline to Week 6 for the Lurasidone 20 mg, and Lurasidone 80 - 160 mg Groups Versus the Placebo Group in the Montgomery-Asberg Depression Rating Scale Total Score|"The MADRS consists of 10 items, each rated on a Likert scale, from 0=Normal to 6=Most Severe. The MADRS total score is calculated as the sum of the 10 items. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity."|Baseline to 6 Weeks|Intent to treat population - only 379 subjects had at least one post-baseline MADRS assessment.||units on a scale||Standard Error|Least Squares Mean
662727|NCT01815918|Primary|Prothrombin Fragment (PF1.2), a Marker of Thrombin Generation|Study patients received 100 mg of intravenous hydrocortisone 2 h prior to surgery, and controls received normal saline. Blood samples, drawn pre-incision and at 4 h post tourniquet release, were assayed for PF1.2 and PAP|Baseline and up to 4 hours following surgery|||pMol/L||Standard Deviation|Mean
662490|NCT01821378|Secondary|Change in Clinical Global Impression-Severity of Illness (CGI-S) Score at Week 6 for Lurasidone 20 mg and 80-160 mg Versus Placebo.|The CGI-S is a clinician-rated assessment of the subject’s current illness state on a 7-point scale (0-7), where a higher score is associated with greater illness severity. Following a clinical interview, the CGI-S can be completed in 1-2 minutes.|Baseline to 6 Weeks|Intent to treat population||units on a scale||Standard Error|Least Squares Mean
662491|NCT01821378|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6 for Lurasidone 20 mg and 80-160 mg Versus Placebo.|The PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity.|Baseline to 6 Weeks|Intent to treat population - there was one subject randomized but not treated with study medication, therefore excluded from ITT population||units on a scale||Standard Error|Least Squares Mean
662492|NCT01821352|Primary|Change in Combined Circumference Measurement|Individual measurements in inches of the waist, hips and upper abdomen were combined to calculate a total combined body circumference measurement. Change in combined circumference measurement is calculated as the difference in circumference measurements from baseline to endpoint (4 weeks). A negative (-) change indicates a decrease in circumference and is positive for study success. A positive (+) change indicates an increase in circumference and is negative for study success.|Baseline and 4 Weeks|||inches||Standard Deviation|Mean
662493|NCT01821352|Other Pre-specified|Subject Satisfaction With Procedure Outcome|"Subjects rated satisfaction with the outcome of the study procedures with respect to change in body shape on the following 5-point scale: Very Satisfied, Somewhat Satisfied, Neither Satisfied nor Dissatisfied, Not Very Satisfied, Not at All Satisfied.
Results are reported as the number of subjects in each treatment group who rated study outcome satisfaction as 'Very Satisfied' or 'Somewhat Satisfied'."|4 Weeks|||participants|||Number
662494|NCT01821352|Primary|Difference in the Proportion of Primary Outcome Successes Between Treatment Groups for Change in Combined Circumference Measurements|Individual measurements in inches of the waist, hips and upper abdomen were combined to calculate a total body circumference measurement. Change in combined circumference measurement from baseline to 4 weeks was calculated for each subject. Individual subject success was defined as a change of 3.0 inches or more in the combined circumference measurement across the evaluation period. A decrease in combined circumference measurement is positive for individual subject success. An increase in combined circumference measurement is negative for individual subject success. Overall study success was defined as a 40% or greater difference between the proportion of individual successes in each treatment group.|Baseline and 4 Weeks|||participants|||Number
662495|NCT01821326|Primary|Rebleeding Rate||10 years|||participants|||Number
662496|NCT01821118|Secondary|Number of Participants With Anti-PF-04360365 Antibodies|Blood samples were collected from participants who received active treatment to assess for presence/absence of anti-PF-04360365 antibodies.|Day 1 up to Day 240|All 24 participants who received PF-04360365 were included in this analysis.||participants|||Number
662497|NCT01821118|Secondary|Number of Participants With Significant Changes in Neurological Examination Results|A complete/full neurological examination included assessment of the cranial nerves; muscle strength, tone, cortical drift, abnormal movements; deep tendon reflexes; sensory exam, coordination, gait and station.|Baseline up till Day 240|All 36 participants who received study drug were included in the analysis.||participants|||Number
662498|NCT01821118|Secondary|Number of Participants With Significant Changes From Baseline in Physical Examination at Final Visit|A complete physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, skeletal, and neurological systems.|Baseline up to Final Visit (Day 240)|All 36 participants who received study drug were included in the analysis.||participants|||Number
662499|NCT01821118|Secondary|Overall Number of Participants With Positive Responses to Questions on the Columbia Suicide Severity Rating Scale (C-SSRS)|"C-SSRS assessed whether participant responded yes to the following: completed suicide, suicide attempt, preparatory acts toward imminent suicidal behavior, suicidal ideation, self-injurious behavior with no suicidal intent."|Baseline up to Day 240|All 36 participants who received study drug were included in the analysis.||participants|||Number
662500|NCT01821118|Secondary|Number of Participants With Vital Signs Values Meeting Categorical Summarization Criteria|Categorical summarization criteria in vital signs included: supine systolic blood pressure (SBP) of less than (<)90 millimeters of mercury (mm Hg) or more than (>) 160 mm Hg; supine diastolic blood pressure (DBP) <50 mm Hg or >100 mm Hg; supine pulse rate of <60 beats per minute (bpm) or >100 bpm; maximum changes (increase or decrease) from baseline in supine SBP of >=20 mm Hg; maximum increase from baseline in supine DBP of >=20 mm Hg; and maximum decrease from baseline in supine DBP of >=10 mm Hg.|Baseline up to Day 240|All 36 participants who received study drug were included in the analysis.||participants|||Number
662501|NCT01821118|Secondary|Number of Participants With Laboratory Abnormalities|Number of participants with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters included hematology, liver function (including Hy's Law Criteria), renal function, electrolytes, clinical chemistry, and urinalysis (dipstick and microscopy).|Baseline up to Day 240|All 36 participants who received study drug were included in the analysis.||participants|||Number
662502|NCT01821118|Secondary|Number of Participants With All Causality and Treatment-related Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations Due to Adverse Events (AEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs comprised both SAEs and non-SAEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse events (TEAEs) were defined as newly occurring AEs or those worsening after first dose.|Baseline up to Day 240|All 36 participants who received study drug were included in the AE summarization/analysis.||participants|||Number
663218|NCT01808209|Secondary|Corneal Staining|Assessment of ocular health. Collected at baseline after removal of lenses. (Biomicroscopy, 0-4, 0=none , 4=severe )|Baseline|Prior to randomization||units on a scale|Participants|Standard Deviation|Mean
662503|NCT01821118|Secondary|Mean Montreal Cognitive Assessment (MoCA) Total Score Over Time|The Montreal Cognitive Assessment (MoCA) was used as a safety outcome measure to assess any changes in cognition. The MoCA is a 1-page 30-point test administered in approximately 10 minutes. The MoCA assessed short term memory, visuospatial abilities, multiple aspects of executive functions, attention, concentration, working memory, and language, as well as orientation to time and place. The total scale ranges from 0 to 30, with lower numbers indicating lower cognition performance.|Screening; Days 0, 1, 30, 60, 90, and 240|All 36 participants who received study treatment were included in the analysis. On Day 240, the number of evaluable participants in the placebo group was 11 instead of 12.||units on a scale||Standard Deviation|Mean
662504|NCT01821118|Secondary|Number of Participants With Brain Structural Magnetic Resonance Imaging (sMRI) Abnormalities|"Brain sMRI abnormalities included cerebral edema and total infarcts (including cortical infarcts, white matter infarcts, and subcortical gray matter infarcts). Total infarcts is the total number of participants with at least 1 type of infarct."|Baseline/Screening, Day 15, Day 45, Day 90,|All 36 participants who received study treatment were analyzed for this endpoint.||participants|||Number
662505|NCT01821118|Secondary|Change From Baseline in Concentration of Total Plasma Amyloid Beta (AB)|Cerebral amyloid angiopathy (CAA) is caused by the progressive deposition of amyloid, predominantly AB40, within the walls of cerebral blood vessels with a predisposition for the vessels of the occipital lobe. As such, it is of interest to investigate the effect of PF-04360365 on AB concentrations. AB1-x and AB1-40 were investigated.|Baseline, 8 hours post dose on Day 1, Day 2, Day 30, 90 and 240|All 36 participants who received study treatment were included in this pharmacodynamic analysis. n=number of participants with measurable AB at the specified time point.||picograms (pg)/milliliter (mL)||Standard Deviation|Mean
662506|NCT01821118|Secondary|Change From Baseline to Day 2 and Day 90 in Cerebrovascular Reactivity as Measured by the Time to Return to Baseline From Visual Task-evoked fMRI|BOLD fMRI was performed at Screening (Baseline) and on Days 2 and 90. During each of these sessions, BOLD fMRI images were acquired in rapid succession as a flashing radial black and white checkerboard was presented alternately with a gray screen. This well established visual stimulus is known to produce a reliable increase in BOLD fMRI signal within the visual cortex region of the occipital lobe. The time course of the BOLD fMRI signal was used to assess the vascular reactivity. Imaging sites also acquired cerebral blood flow data using ASL scans at Screening and on Days 2 and 90. A standard T1-weighted image was also acquired to aid image analysis. All efficacy scans were analyzed centrally. All values are presented in log e scale.|Baseline, Day 2, Day 90|The full analysis set (FAS) consisted of all participants who received at least 1 post-dose efficacy measurement. n=number of evaluable participants for the specified ROI at the specified day.||seconds||90% Confidence Interval|Least Squares Mean
662507|NCT01821118|Secondary|Change From Baseline to Day 2 and Day 90 in Cerebrovascular Reactivity as Measured by the Amplitude From Visual Task-evoked fMRI|BOLD fMRI was performed at Screening (Baseline) and on Days 2 and 90. During each of these sessions, BOLD fMRI images were acquired in rapid succession as a flashing radial black and white checkerboard was presented alternately with a gray screen. This well established visual stimulus is known to produce a reliable increase in BOLD fMRI signal within the visual cortex region of the occipital lobe. The time course of the BOLD fMRI signal was used to assess the vascular reactivity. Imaging sites also acquired cerebral blood flow data using ASL scans at Screening and on Days 2 and 90. A standard T1-weighted image was also acquired to aid image analysis. All efficacy scans were analyzed centrally. All values are presented in log e scale.|Baseline, Day 2, Day 90|The full analysis set (FAS) consisted of all participants who received at least 1 post-dose efficacy measurement. n=number of evaluable participants for the specified ROI at the specified day.||percent||90% Confidence Interval|Least Squares Mean
662508|NCT01821118|Secondary|Change From Baseline to Day 2 and Day 90 in Cerebrovascular Reactivity as Measured by the Time to Peak From Visual Task-evoked fMRI|BOLD fMRI was performed at Screening (Baseline) and on Days 2 and 90. During each of these sessions, BOLD fMRI images were acquired in rapid succession as a flashing radial black and white checkerboard was presented alternately with a gray screen. This well established visual stimulus is known to produce a reliable increase in BOLD fMRI signal within the visual cortex region of the occipital lobe. The time course of the BOLD fMRI signal was used to assess the vascular reactivity. Imaging sites also acquired cerebral blood flow data using ASL scans at Screening and on Days 2 and 90. A standard T1-weighted image was also acquired to aid image analysis. All efficacy scans were analyzed centrally. Geometric means are presented in the original scale and SEs are presented in log e scale.|Baseline, Day 2, Day 90|The full analysis set (FAS) consisted of all participants who received at least 1 post-dose efficacy measurement. n=number of evaluable participants for the specified ROI at the specified day.||seconds||Standard Error|Geometric Mean
662509|NCT01821118|Primary|Change From Baseline to Day 90 in Cerebrovascular Reactivity as Measured by the Slope (Amplitude Over Time to Peak) From Visual Task-evoked fMRI|BOLD fMRI was performed at Screening (Baseline) and on Days 2 and 90. During each of these sessions, BOLD fMRI images were acquired in rapid succession as a flashing radial black and white checkerboard was presented alternately with a gray screen. This well established visual stimulus is known to produce a reliable increase in BOLD fMRI signal within the visual cortex region of the occipital lobe. The time course of the BOLD fMRI signal was used to assess the vascular reactivity. Imaging sites also acquired cerebral blood flow data using ASL scans at Screening and on Days 2 and 90. A standard T1-weighted image was also acquired to aid image analysis. All efficacy scans were analyzed centrally. Geometric means are presented in the original scale and SEs are presented in log e scale.|Baseline, Day 90|The full analysis set (FAS) consisted of all participants who received at least 1 post-dose efficacy measurement. n=number of evaluable participants for the specified ROI at Day 90.||percent/second||Standard Error|Geometric Mean
662534|NCT01819922|Secondary|Change From Baseline in Early and Late Peak Velocity|Tissue velocities were measured off-line from 2D color-coded tissue doppler images and reported as the average of 3 consecutive cardiac cycles. Tissue Doppler Imaging measured the velocity of the heart muscle or myocardium through the phases of one or more heartbeats by the Doppler effect (frequency shift) of the reflected ultrasound. Change from baseline in early and late peak tissue velocities were reported.|1 hour 30 minutes and 2 hours 5 minutes post-dose|"FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement. Here, n specified the number of participants who were evaluable for the specified time-point."||cm/sec||Standard Deviation|Mean
662510|NCT01821118|Primary|Change From Baseline to Day 2 in Cerebrovascular Reactivity as Measured by the Slope (Amplitude Over Time to Peak) From Visual Task-evoked Functional Magnetic Resonance Imaging (fMRI)|Blood Oxygen Level Dependant (BOLD) fMRI was performed at Screening (Baseline) and on Days 2 and 90. During each of these sessions, BOLD fMRI images were acquired in rapid succession as a flashing radial black and white checkerboard was presented alternately with a gray screen. This well established visual stimulus is known to produce a reliable increase in BOLD fMRI signal within the visual cortex region of the occipital lobe. The time course of the BOLD fMRI signal was used to assess the vascular reactivity. Imaging sites also acquired cerebral blood flow data using Arterial Spin Labeled (ASL) scans at Screening and on Days 2 and 90. A standard T1-weighted image was also acquired to aid image analysis. All efficacy scans were analyzed centrally. Geometric means are presented in the original scale and standard errors (SE) are presented in logarithmic (log e) scale.|Baseline, Day 2|The full analysis set (FAS) consisted of all participants who received at least 1 post-dose efficacy measurement. n=number of evaluable participants for the specified region of interest (ROI) at Day 2.||percent/second||Standard Error|Geometric Mean
662511|NCT01821105|Secondary|Tumor Detection||At surgery|||lesions detected|||Number
662512|NCT01821105|Secondary|All Adverse Events and Complications||up to 12 months|||patients|||Number
662513|NCT01821105|Primary|Detection of Position Accuracy With Handheld Probe on Anatomical Location.||up to 12 months|number of tumor lesions detected by the probe||lesions|Participants||Number
662514|NCT01820585|Primary|Absolute Change From Baseline to Endpoint in Mean Pain|The primary efficacy variable was the absolute change from baseline to endpoint in mean pain. Pain intensity was assessed on an 11-point (0-10) Numeric pain rating scale (NPRS), where 0 = no pain and 10 = worst possible pain and was recorded in a subject’s diary. The subject was instructed to complete the assessment daily on awakening.Primary analyses were conducted on the full analysis set (FAS) which consisted of all randomised subjects who received at least 1 dose of study medication and with at least 1 post-randomisation rating of 24-h-average pain. The primary efficacy variable was the absolute change from baseline to endpoint in mean pain recorded in a subject’s diary upon awakening each morning. An ANCOVA on the FAS revealed no statistically significant differences between the 3 ESL groups and the placebo group after 13 weeks of treatment.|Baseline and 13 Weeks|||units on a scale||Standard Error|Least Squares Mean
662515|NCT01820559|Primary|Absolute Change From Baseline in the Frequency of Migraine Attacks|The primary efficacy variable was the absolute change from baseline in the frequency of migraine attacks standardised to 4 weeks in the Maintenance Period, as recorded in the subject diary. If there were less than 24 h between the end of 1 migraine event and the start of the next event, these 2 events were considered to belong to 1 migraine attack. There had to be a minimum of 24 h of freedom from headache, pain, and symptoms of migraine between attacks recorded in the subject diary to be considered as more than 1 attack of migraine for statistical analysis.|4 weeks|||number of migraine attacks/participant||Standard Error|Least Squares Mean
662516|NCT01820416|Primary|Change in Speech Perception|Hearing status, as assessed by the Connected Sentence Test (CST). Difference scores (post-test - pretest) are reported. The CST approximates everyday conversation. Scoring is based on the number of correctly repeated key words. Higher numbers indicate better scores. The minimum score is 0 (0%) and the maximum is 100 (100%). When comparing test-retest scores for an individual, Cox et al. (1988) suggest that changes of 15% or more (based on 100 key words) are indicative of significant changes. We subtracted the post-test from the pre-test, so that negative difference scores indicate worse performance, and positive difference scores indicate better performance. Difference scores with an absolute value smaller than 15 are interpreted as no significant change. In addition, pre- and post-test performance was assessed for groups using t-tests on the difference scores.|7-10 days after baseline measures recorded|||difference scores||Standard Deviation|Mean
662517|NCT01820364|Secondary|Molecular Status of Markers Relevant to the RAP/MEK/ERK and PI3K/AKT Pathways|Molecular status was not evaluated due to an inadequate number of patients enrolled in Part II prior to the permanent recruitment halt of this study.|Baseline and at progression with LGX818 single agent treatment||||||
662518|NCT01820364|Secondary|Tumor Response (Overall Response Rate) Via Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 (Part II)|"Response Evaluation Criteria In Solid Tumors (RECIST) is a set of published rules that define the status of tumors in cancer patients during a specific treatment.
The Overall Response Rate was calculated according to the RECIST criteria, as per investigator assessment.
Per RECIST guidelines:
Complete Response (CR) is the Disappearance of all target lesions.
Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions.
Progressive Disease (PD) is the at least a 20% increase in the sum of diameters of target lesions.
Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
One patient with documented PD at study Day 146 entered into Part II of the study and received combination treatment of LGX818 450 mg plus MEK162 45 mg for two weeks. The patient experienced disease progression on Day 22 of Part II and discontinued the study."|Entry to Part II of the study through study completion (approximately 22 days)|This analysis group is comprised of the Full Analysis Set, which consists of all patients who received at least one dose of LGX818.||participants|||Number
662519|NCT01820364|Secondary|Tumor Response (Overall Response Rate) Via Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 (Part I)|"Response Evaluation Criteria In Solid Tumors (RECIST) is a set of published rules that define the status of tumors in cancer patients during a specific treatment.
The Overall Response Rate was calculated according to the RECIST criteria, as per investigator assessment.
Per RECIST guidelines:
Complete Response (CR) is the Disappearance of all target lesions.
Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions.
Progressive Disease (PD) is the at least a 20% increase in the sum of diameters of target lesions.
Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD."|Baseline through completion of Part I of the study (approximately 2 years)|This analysis is comprised of the Full Analysis Set, which consists of all patients who received at least one dose of LGX818.||participants|||Number
662520|NCT01820364|Secondary|Plasma Concentration and Derived Pharmacokinetic Parameters|Assessment of pharmacokinetic (PK) parameters and plasma concentration was not done due to an inadequate number of patients enrolled in Part II prior to the permanent recruitment halt of this study.|Baseline through study completion (approximately 2 years)||||||
663979|NCT01792986|Secondary|Difference in Low-density Lipoprotein Cholesterol (LDL-C) Between Baseline and the End of the Sixth Week.||6 weeks|||mg/dL||Standard Deviation|Mean
662522|NCT01820364|Primary|Tumor Response (Overall Response Rate) Per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 (Part I & Part II)|"Response Evaluation Criteria In Solid Tumors (RECIST) is a set of published rules that define the status of tumors in cancer patients during a specific treatment.
The Overall Response Rate was calculated according to the RECIST criteria, as per investigator assessment.
Per RECIST guidelines:
Complete Response (CR) is the Disappearance of all target lesions.
Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions.
Progressive Disease (PD) is the at least a 20% increase in the sum of diameters of target lesions.
Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD."|Baseline through study completion (approximately 2 years)|This analysis is comprised of the Full Analysis Set, which consists of all patients who received at least one dose of LGX818.||participants|||Number
662523|NCT01819935|Secondary|Clinical Success|Clinical success, a composite outcome defined as discharge from the hospital or ICU by day 14 after treatment initiation, in the absence of death, therapy change, or intubation by day 14. Percentage of participants with clinical success was reported.|Baseline (1 January 2001) up to 3559 Days (30 September 2010)|"FAS included all participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure."||percentage of participants|||Number
662524|NCT01819935|Secondary|Time to 30-day Methicillin-Resistant Staphylococcus Aureus (MRSA) Re-infection|Time to MRSA re-infection was defined as readmission with MRSA infection to any veterans affairs hospital facility within 30 days after hospital discharge.|Baseline (1 January 2001) up to 3559 Days (30 September 2010)|FAS included all participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia.||days||Full Range|Median
662525|NCT01819935|Secondary|Time to 30-day Re-admission|Time to readmission to any veterans affairs hospital facility within 30 days after hospital discharge was reported.|Baseline (1 January 2001) up to 3559 Days (30 September 2010)|FAS included all participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia.||days||Full Range|Median
662526|NCT01819935|Secondary|Time to Intubation|Time to intubation was calculated from the initiation of therapy (index date) to intubation (event date).|Baseline (1 January 2001) up to 3559 Days (30 September 2010)|FAS included all participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia.||days||Full Range|Median
662527|NCT01819935|Secondary|Time to Transfer Out From the Intensive Care Unit (ICU)|Time to discharge from the ICU was calculated from the initiation of therapy (index date) to the time the participant was transferred out from ICU (event date). Transfer out of an ICU was assessed among those participants who had initiated linezolid or vancomycin therapy in the ICU.|Baseline (1 January 2001) up to 3559 Days (30 September 2010)|FAS included all participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia.||days||Full Range|Median
662528|NCT01819935|Secondary|Time to Discharge From the Hospital|Time to discharge from hospital was calculated from initiation of therapy (index date) to hospital discharge (event date).|Baseline (1 January 2001) up to 3559 Days (30 September 2010)|FAS included all participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia.||days||Standard Deviation|Mean
662529|NCT01819935|Secondary|Time to Therapy Change|Time to therapy change was calculated from initiation of therapy (index date) to change in therapy (event date). Therapy change was defined as the discontinuation of linezolid or vancomycin and initiation of a different agent with activity against MRSA (clindamycin, daptomycin, doxycycline, linezolid, minocycline, tigecycline, trimethoprim/sulfamethoxazole, vancomycin). As such, therapy change included switching from linezolid to vancomycin, switching from vancomycin to linezolid, or switching from either linezolid or vancomycin to another anti-MRSA antibiotic.|Baseline (1 January 2001) up to 3559 Days (30 September 2010)|FAS included all participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia.||days||Full Range|Median
662530|NCT01819935|Primary|Time to 30-day Mortality|Time to death (all-cause mortality) occurring within 30 days of treatment initiation was reported. Mortality was assessed from admission vital status databases.|Baseline (1 January 2001) up to 3559 Days (30 September 2010)|FAS included all participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia.||days||Full Range|Median
662531|NCT01819922|Secondary|Plasma Metabolomic Profiles Before and Immediately Following Steady State and Incremental Exercise|Plasma metabolomic profiles before and immediately following steady state and incremental exercise were collected using vacutainer tube containing dipotassium ethylenediamine tetraacetic Acid (K2EDTA) were processed by the clinical site according to handling specifications.|1 hour pre-dose, 1 hour 20 minutes and 2 hours 10 minutes post-dose|Data was not collected for this outcome measure as per study team’s decision since single dose was not considered to be sufficient to analyze this specific parameter.|||||
662532|NCT01819922|Secondary|Peak Diastolic Untwisting Rate|Diastolic untwisting is an important component of early diastolic left ventricular filling. Left ventricular diastolic function is determined by early diastolic relaxation and myocardial stiffness. Peak diastolic untwisting rate is defined as the rate of left ventricular relaxation. It was assessed by echocardiography using speckled tracking analysis.|20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose|Data was not collected for this outcome measure as per study team’s decision since single dose was not considered to be sufficient to analyze this specific parameter.|||||
662533|NCT01819922|Secondary|Diastolic Strain Rate|Diastolic strain rate was defined as the rate of percent change in all segments of left ventricular dimension in comparison to its original dimension. It was assessed by echocardiography using speckled tracking analysis.|20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose|Data was not collected for this outcome measure as per study team’s decision since single dose was not considered to be sufficient to analyze this specific parameter.|||||
663219|NCT01808209|Secondary|Conjunctival Redness|Assessment of ocular health. Collected at 1 week after removal of lenses. Percentage of conjunctival redness.|1 Week|All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.||percentage of redness|Participants|Standard Deviation|Mean
662535|NCT01819922|Secondary|Early and Late Peak Tissue Velocity|Tissue velocities were measured off-line from two dimensional (2D) color-coded tissue doppler images and reported as the average of 3 consecutive cardiac cycles. Tissue Doppler Imaging measured the velocity of the heart muscle or myocardium through the phases of one or more heartbeats by the Doppler effect (frequency shift) of the reflected ultrasound. Early and late peak tissue velocities (EPV and LPV) were reported.|20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose|"FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement. Here, n specified the number of participants who were evaluable for the specified time-point."||cm/sec||Standard Deviation|Mean
662536|NCT01819922|Secondary|Change From Baseline in Trans-mitral Doppler Time|Trans-mitral doppler time was measured as the time between the closure of the aortic valve and the opening of the mitral valve. It was determined on spectral doppler echocardiography. Change from baseline in trans-mitral doppler time was reported.|1 hour 30 minutes and 2 hours 5 minutes post-dose|"FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement. Here, n specified the number of participants who were evaluable for the specified time-point."||msec||Standard Deviation|Mean
662537|NCT01819922|Secondary|Trans-mitral Doppler: Time|Trans-mitral doppler time was measured as the time between the closure of the aortic valve and the opening of the mitral valve. It was determined on spectral doppler echocardiography.|20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose|"FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement. Here, n specified the number of participants who were evaluable for the specified time-point."||msec||Standard Deviation|Mean
662538|NCT01819922|Secondary|Change From Baseline in Trans-mitral Doppler Ratio|Trans-mitral doppler ratio was Transmitral E wave peak velocity divided by transmitral A wave peak velocity. The E/A ratio was defined the ratio of the early (E) to late (A) ventricular filling velocities and was marker of the function of the left ventricle of the heart. It was determined on spectral doppler echocardiography. Change from baseline in trans-mitral ration was reported.|1 hour 30 minutes and 2 hours 5 minutes post-dose|"FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement. Here, n specified the number of participants who were evaluable for the specified time-point."||ratio||Standard Deviation|Mean
662539|NCT01819922|Secondary|Trans-mitral Doppler: Ratio|Trans-mitral doppler ratio was Transmitral E wave peak velocity divided by transmitral A wave peak velocity. The E/A ratio was defined the ratio of the early (E) to late (A) ventricular filling velocities and was marker of the function of the left ventricle of the heart. It was determined on spectral doppler echocardiography.|20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes|"FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement. Here, n specified the number of participants who were evaluable for the specified time-point."||ratio||Standard Deviation|Mean
662540|NCT01819922|Secondary|Change From Baseline in Systolic Global Strain Rate|Global longitudinal left ventricular strain rate was defined as the rate of percent change in left ventricular longitudinal dimension in comparison to its original dimension. Global strain rate was assessed by echocardiography using speckled tracking analysis. Change from baseline in systolic global strain rate was reported.|1 hour 30 minutes and 2 hours 5 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.||percent change per second||Standard Deviation|Mean
662541|NCT01819922|Secondary|Systolic Function: Global Strain Rate|Global longitudinal left ventricular strain rate was defined as the rate of percent change in left ventricular longitudinal dimension in comparison to its original dimension. Global strain rate was assessed by echocardiography using speckled tracking analysis.|20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.||percent change per second||Standard Deviation|Mean
662542|NCT01819922|Secondary|Systolic Function: Rotation/Torsion|Torsion is the twisting of an object due to an applied torque. It is expressed in newton metres. The left ventricle twists in systole storing potential energy and untwists (recoils) in diastole releasing the energy. Twist aids left ventricular ejection and untwist aids relaxation and ventricular filling. Therefore, rotation and torsion are important in cardiac mechanics. It was assessed by echocardiography using speckled tracking analysis .|20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose|Data was not collected for this outcome measure as per study team’s decision since single dose was not considered to be sufficient to analyze this specific parameter.|||||
662543|NCT01819922|Secondary|Change From Baseline in Peak Contractile Velocity|It was assessed by echocardiography using Tissue Doppler Imaging (Color Post-Processing). Change from baseline in peak contractile velocity was reported.|1 hour 30 minutes and 2 hours 5 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.||cm/sec||Standard Deviation|Mean
662544|NCT01819922|Secondary|Systolic Function: Peak Contractile Velocity|It was assessed by echocardiography using Tissue Doppler Imaging (Color Post-Processing).|20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.||centimeter per second (cm/sec)||Standard Deviation|Mean
662545|NCT01819922|Secondary|Change From Baseline in Ejection Fraction|Systolic ejection fraction was the fraction of the end-diastolic volume that was ejected out of left ventricle with each contraction, estimated by echocardiography. EDV was the volume of blood within a ventricle immediately before a contraction. Ejection fraction served as a general measure of the cardiac function of a participant. Change from baseline in ejection fraction was reported.|1 hour 30 minutes and 2 hours 5 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.||percentage of EDV||Standard Deviation|Mean
663980|NCT01792986|Secondary|Difference in Weight Between Baseline and the End of the Sixth Week||6 weeks|||kg||Standard Deviation|Mean
662546|NCT01819922|Secondary|Systolic Function: Ejection Fraction|Systolic ejection fraction was the fraction of the end-diastolic volume (EDV) that was ejected out of left ventricle with each contraction, estimated by echocardiography. EDV was the volume of blood within a ventricle immediately before a contraction. Ejection fraction served as a general measure of the cardiac function of a participant.|20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.||percentage of EDV||Standard Deviation|Mean
662547|NCT01819922|Secondary|Change From Baseline in Atrial Volumes|Atrial volumes were assessed by echocardiography using 2-dimensional gray-scale imaging and were calculated using the bi-plane area-length method. Both end-systole volumes and end-diastole volumes were reported. Change from baseline in atrial volume was reported.|1 hour 30 minutes and 2 hours 5 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.||mL||Standard Deviation|Mean
662548|NCT01819922|Secondary|Cardiac Structure: Atrial Volume|Atrial volumes were assessed by echocardiography using 2-dimensional gray-scale imaging and were calculated using the bi-plane area-length method. Both end-systole volumes (ESV) and end-diastole volumes (EDV) were reported.|20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.||mL||Standard Deviation|Mean
662549|NCT01819922|Secondary|Change From Baseline in Right Ventricular Dimension|Right ventricle is the chamber in the heart responsible for pumping blood to the lungs. Right ventricular dimensions included end-diastole area and end-systole area. It was assessed by echocardiography using 2-dimensional gray-scale imaging. Change from baseline in right ventricular dimension was reported.|1 hour 30 minutes and 2 hours 5 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.||mm||Standard Deviation|Mean
662550|NCT01819922|Secondary|Cardiac Structure: Right Ventricular Dimension|Right ventricle is the chamber in the heart responsible for pumping blood to the lungs. Right ventricular dimensions included end-diastole area (EDA) and end-systole area (ESA). It was assessed by echocardiography using 2-dimensional gray-scale imaging.|20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.||millimetre (mm)||Standard Deviation|Mean
662551|NCT01819922|Secondary|Cardiac Structure: Left Ventricular Geometry|Left ventricular geometry was assessed by echocardiography using 2-dimensional gray-scale imaging. Relative wall thickness was the index of left ventricular geometry and defined as the sum of interventricular septal thickness (mm) and posterior wall thickness (mm) divided by LV internal end-diastolic diameter (mm).|20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose|Data was not collected for this outcome measure as per study team’s decision since single dose was not considered to be sufficient to analyze this specific parameter.|||||
662552|NCT01819922|Secondary|Cardiac Structure: Left Ventricular Wall Thickness|Left ventricle is the chamber in the heart responsible for pumping blood to the rest of the body. Thickening of the lower chambers of left ventricular wall is also termed as ventricular hypertrophy. It was assessed by echocardiography using 2-dimensional gray-scale imaging; M-mode.|20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose|Data was not collected for this outcome measure as per study team’s decision since single dose was not considered to be sufficient to analyze this specific parameter.|||||
662553|NCT01819922|Secondary|Change From Baseline in the Left Ventricular Volume|Left ventricular volume was defined as volume of blood pumped from the left ventricle to the heart per beat. It was calculated using measurements of ventricle volumes from an echocardiogram and subtracting the volume of the blood in the ventricle at the end of a beat (called end-systolic volume) from the volume of blood just prior to the beat (called end-diastolic volume). Change from baseline in left ventricular volume was reported using modified Simpson’s technique.|1 hour 30 minutes and 2 hours 5 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.||mL||Standard Deviation|Mean
662554|NCT01819922|Secondary|Cardiac Structure: Left Ventricular Volume|Left ventricular volume was defined as volume of blood pumped from the left ventricle to the heart per beat. It was calculated using measurements of ventricle volumes from an echocardiogram and subtracting the volume of the blood in the ventricle at the end of a beat (called end-systolic volume) from the volume of blood just prior to the beat (called end-diastolic volume). Left ventricular volume was reported using modified Simpson’s technique.|20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.||mL||Standard Deviation|Mean
662555|NCT01819922|Secondary|Cardiopulmonary Exercise Test: Physical Work Capacity at a Heart Rate of 130 Beats Per Minute (PWC 130)|Physical work capacity evaluates the capacity of an individual to perform physically demanding work tasks. PWC 130 was a simple sub-max exercise parameter that can be used as surrogate for fitness that was independent of metabolic cart measurements. Interventions that improve fitness improve the PWC 130.|1 hour 40 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.||bpm||Standard Deviation|Mean
662556|NCT01819922|Secondary|Cardiopulmonary Exercise Test: Aerobic Efficiency|Aerobic efficiency was defined as volume of oxygen divided by work. This parameter was assessed during cardiovascular exercise test.|1 hour 40 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.||mL/watt||Standard Deviation|Mean
662557|NCT01819922|Secondary|Cardiopulmonary Exercise Test: Oxygen (O2) Kinetics|Oxygen kinetics describes the dependence of respiration of isolated cells on oxygen partial pressure. The characteristics of oxygen uptake kinetics differ with intensity of exercise.|1 hour 40 minutes post-dose|Data was not collected for this outcome measure as per study team’s decision since single dose was not considered to be sufficient to analyze this specific parameter.|||||
662558|NCT01819922|Secondary|Cardiopulmonary Exercise Test: Oxygen (O2) Pulse|Oxygen Pulse (VO2 /Heart Rate) was equal to stroke volume multiplied by oxygen extraction. This parameter was assessed during cardiopulmonary exercise test.|1 hour 40 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.||mL/beat||Standard Deviation|Mean
662559|NCT01819922|Secondary|Cardiopulmonary Exercise Test: Volume of Oxygen (VO2) at Anaerobic Threshold (AT)|VO2 at anaerobic threshold was widely recognized as a sub-max indicator of fitness. The parameter was assessed during indirect calorimetry.|1 hour 40 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.||mL||Standard Deviation|Mean
662560|NCT01819922|Secondary|Cardiopulmonary Exercise Test: Minute Ventilation and Carbon Dioxide Production (VE/VCO2 Slope)|VE/VCO2 slope was also termed as ventilator efficiency. It was defined as the amount of minute ventilation required to eliminate 1 liter of carbon dioxide. The determinants of VE/VCO2 included fractional dead space and partial pressure of carbon dioxide. The parameter was assessed during indirect calorimetry.|1 hour 40 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.||unitless||Standard Deviation|Mean
662561|NCT01819922|Secondary|Cardiopulmonary Exercise Test: Respiratory Exchange Ratio (RER)|RER was defined as the ratio between the amount of oxygen (O2) consumed and carbon dioxide (CO2) produced in one breath. The parameter was assessed during indirect measure of heat production (calorimetry).|1 hour 40 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.||ratio||Standard Deviation|Mean
662562|NCT01819922|Secondary|Cardiopulmonary Exercise Test: Peak Volume of Oxygen (VO2)|VO2 was the maximum rate of oxygen consumption as measured during incremental or prolonged, sub-maximal exercise. It reflects the aerobic physical fitness of the individual. It was assessed during indirect measure of heat production (calorimetry). The unit of measure is milliliter per kilogram per minute (mL/kg/min).|1 hour 40 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.||mL/kg/min||Standard Deviation|Mean
662563|NCT01819922|Secondary|Number of Participants With Categorical Post-dose Cardiovascular Monitoring Data: Electrocardiogram (ECG) Parameters|Criteria for clinically significant ECG values included: maximum PR interval >=300 millisecond (msec) and maximum increase of >=25 percent (%) from baseline value of >200 msec and >=50 % for baseline value of <=200 msec, maximum QRS interval >=140 msec or maximum increase of >=50% for baseline value of >100 msec; QT interval corrected using the Fridericia formula (QTcF) 450-<480 msec, 480-<500, >=500 msec or increase of >45 msec or maximum increase of >=30 to <60 and >=60 msec for QT interval where, PR interval: interval between the start of the P wave and the start of the QRS complex corresponding to the time between the onset of atrial depolarization and onset of ventricular depolarization; QRS interval: time from electrocardiogram Q wave to the end of the T wave corresponding to ventricle depolarization, QTcF interval: time corresponding to the beginning of depolarization to repolarization of the ventricles.|Baseline up-to 3 hour post-dose|Safety analysis set was defined as all participants who performed the peak aerobic capacity test, were randomized and who had received at least 1 dose of randomized treatment.||participants|||Number
662564|NCT01819922|Secondary|Number of Participants With Categorical Post-dose Cardiovascular Monitoring Data|Participants who met the pre-defined criteria for clinically significant cardiovascular events were reported. Criteria for clinically significant cardiovascular events: Blood pressure (BP) [supine systolic and sitting systolic BP (SBP): <90 millimeter of mercury (mm Hg), >=30 mmHg maximum increase and decrease from baseline in same posture; supine diastolic and sitting diastolic BP (DBP): <50 mm Hg, >=20 mmHg maximum increase and >=30 mmHg maximum decrease from baseline in same posture]; pulse rate: supine and sitting: <40 or >120 bpm.|Baseline up-to 3 hours post-dose|"Safety analysis set was defined as all participants who performed the peak aerobic capacity test, were randomized and who had received at least 1 dose of randomized treatment. Here, n specified the number of participants who were evaluable for the specified criteria."||participants|||Number
662565|NCT01819922|Secondary|Number of Participants With Clinically Significant Laboratory Abnormalities|Criteria for clinically significant:Hematology (hemoglobin,hematocrit,red blood corpuscles [RBC] count:less than [<]0.8*lower limit of normal [LLN];platelets:<0.5*LLN/greater than [>]1.75*upper limit of normal [ULN];white blood corpuscles [WBC]:<0.6*LLN or >1.5*ULN;lymphocytes, total neutrophils:<0.8*LLN or >1.2*ULN;basophils,eosinophil, monocytes:>1.2*ULN);Liver Function(aspartate aminotransferase, alanine aminotransferase,alkaline phosphatase:>0.3*ULN;total protein,albumin:<0.8*LLN or >1.2*ULN;total bilirubin:>1.5*ULN);Renal Function (blood urea nitrogen,creatinine:>1.3*ULN; uric acid:>1.2*ULN);Electrolytes (sodium:<0.95*LLN or >1.05*ULN,potassium,chloride, calcium,bicarbonate:<0.9*LLN or >1.1*ULN; glucose fasting:<0.6*LLN or >1.5*ULN);Urinalysis (urine pH:>1.5*ULN or >4.5;urine glucose,ketones,proteins, nitrites, leukocyte esterase,blood/hemoglobin:greater than or equal to (>=)1;urine WBC and RBC,urine bacteria:>=20/High Power Field [HPF];epithelial cells:>=6/HPF).|Baseline up-to 3 hours post-dose|Safety analysis set was defined as all participants who performed the peak aerobic capacity test, were randomized and who had received at least 1 dose of randomized treatment.||participants|||Number
662566|NCT01819922|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event. Treatment-emergent were events between first dose of study drug and up to 5-10 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. Adverse events included both serious and non-serious adverse events.|Baseline up to 5-10 days after last dose of study drug (up to 25 days)|Safety analysis set was defined as all participants who performed the peak aerobic capacity test, were randomized and who had received at least 1 dose of randomized treatment.||participants|||Number
663981|NCT01792986|Primary|Difference in Mean Glucose Level Between Baseline and the End of the Sixth Week.||6 weeks|||mg/dL||Standard Deviation|Mean
662567|NCT01819922|Primary|Cardiopulmonary Exercise Test: Oxygen Uptake Efficiency Slope (OUES): 1 Hour 40 Minute Post-dose|OUES was defined as an index of cardiopulmonary functional reserve that was based upon a submaximal exercise effort. OUES relates oxygen uptake to total ventilation during exercise.|1 hour 40 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.||mL/log10(L)||Standard Deviation|Mean
662568|NCT01819922|Primary|Systolic Function: Global Longitudinal Left Ventricular (LV) Strain: 2 Hours 5 Minutes Post-dose|Global longitudinal left ventricular strain was defined as the percent change in left ventricular longitudinal dimension in comparison to its original dimension. Global longitudinal LV strain was assessed by echocardiography using speckled tracking analysis.|2 hours 5 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.||percent change||Standard Deviation|Mean
662569|NCT01819922|Primary|Systolic Function: Global Longitudinal Left Ventricular (LV) Strain: 1 Hour 30 Minutes Post-dose|Global longitudinal left ventricular strain was defined as the percent change in left ventricular longitudinal dimension in comparison to its original dimension. Global longitudinal LV strain was assessed by echocardiography using speckled tracking analysis.|1 hour 30 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.||percent change||Standard Deviation|Mean
662570|NCT01819922|Primary|Systolic Function: Global Longitudinal Left Ventricular (LV) Strain: 20 Minutes Pre-dose|Global longitudinal left ventricular strain was defined as the percent change in left ventricular longitudinal dimension in comparison to its original dimension. Global longitudinal LV strain was assessed by echocardiography using speckled tracking analysis.|20 minutes pre-dose|Full analysis set (FAS) was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 pharmacodynamic (PD) measurement.||percent change||Standard Deviation|Mean
662571|NCT01819844|Secondary|Accuracy of the CGM Device Using the GlucoScout Measurements as the Standard.|The Mean Absolute Relative Difference (MARD) between CGM and Glucoscout|12 hours|||percent absolute relative difference||Standard Deviation|Mean
662572|NCT01819844|Secondary|Dextrose Dosing (g/kg)||12 hours|||grams/kilogram||Standard Deviation|Mean
662573|NCT01819844|Secondary|Insulin Dosing (u/kg)||12 hours|||units/kilogram||Standard Deviation|Mean
662574|NCT01819844|Secondary|Fraction of Time Spent Within Each of the Following Glucose Ranges as Determined From the CGM Driving the Control Algorithm: o < 70 mg/dl o 70-120 mg/dl o 70-180 mg/dl o >180 mg/dl||12 hours|||percentage of time||Standard Deviation|Mean
662575|NCT01819844|Secondary|Number of BG Events < 70 mg/dl as Determined by the CGM||12 hours|||events|||Number
662576|NCT01819844|Secondary|Average Blood Glucose Over the Closed-loop Control Period as Determined From the CGM Driving the Control Algorithm||12 hours|||mg/dl||Standard Deviation|Mean
662577|NCT01819844|Secondary|Fraction of Time Spent Within Each of the Following Glucose Ranges as Determined From GlucoScout Measurements: - < 70 mg/dl - 70-120 mg/dl - 70-180 mg/dl - >180 mg/dl||12 hours|||percentage of time||Standard Deviation|Mean
662578|NCT01819844|Secondary|Number of BG Events < 70 mg/dl and Nadir BG for Each as Determined Form GlucoScout Measurements||12 hours|||Blood glucose values < 70 mg/dl|||Number
662579|NCT01819844|Secondary|Number of Carbohydrate Interventions (15 g) Delivered According to Study Protocol||12 hours|||number of carbohydrate interventions|||Number
662580|NCT01819844|Primary|Average Blood Glucose Over the Closed-loop Control Period, as Determined From GlucoScout Measurements.||12 hours|||mg/dl||Standard Deviation|Mean
662581|NCT01819415|Secondary|Central Foveal Thickness|Measured with spectral-domain optical coherence tomography.|During at least 12 months of follow-up after vitreous biopsy.||||||
662582|NCT01819415|Primary|Lipidomics Profile||1 day (At the time of vitreous biopsy)||||||
662583|NCT01819415|Primary|Vitreal VEGF Levels.||1 day (At the time of vitreous biopsy)|||pg/ml|||Number
662590|NCT01819272|Secondary|Change in HbA1c (%) at 12 Weeks||Baseline and 12 weeks after the first dose of study medication|Week 12 Evaluable||HbA1c (%)||Standard Error|Least Squares Mean
662591|NCT01819272|Secondary|AUC4-12wk of Change in Fasting Plasma Glucose (mg/dL*Week) Concentrations From Baseline to 12 Weeks||Baseline and 4 to 12 weeks after the first dose of study medication|Week 12 Evaluable||mg/dL*week||Full Range|Median
662592|NCT01819272|Primary|Change in Fasting Plasma Glucose (mg/dL) at 4 Weeks||Baseline and 4 weeks after the first dose of study medication|Week 4 Evaluable||mg/dL||Full Range|Median
662593|NCT01819194|Primary|Meibbomian Gland Dysfunction (MGD)as Measured by MGD Scale|Meibomian Gland Dysfunction (MGD) as measured using the MGD 0 – 11 scale translated into grades 0 to 3 where 0 refers to absence of markers.|Post 3 days of wear|Subjects analyzed are those who enrolled, randomized, and completed the study per protocol.||eyes|Participants||Number
662594|NCT01819194|Primary|Comfort as Measured by the Contact Lens Users Experience Questionnaire (CLUE)|CLUE is survey that is used to assess subjective comfort of the test article. The higher the score the better on a range of 0 to 120.|Post 3 days of wear|Subjects are those who were enrolled, randomized, and completed the study per protocol.||units on a scale||Standard Deviation|Mean
662595|NCT01818752|Secondary|Number of Participants With Adverse Events|"Adverse events (AEs)were graded using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 4.03, where GRADE 1 = Mild; GRADE 2 = Moderate; GRADE 3 = Severe; GRADE 4 = Life-threatening; GRADE 5 = Fatal.
A serious adverse event is an adverse event that met 1 or more of the following criteria:
Death
Life-threatening
Required inpatient hospitalization or prolongation of an existing hospitalization
Resulted in persistent or significant disability/incapacity
Congenital anomaly/birth defect
Important medical event that jeopardized the participant and may have required medical or surgical intervention to prevent 1 of the outcomes listed above.
Treatment-related adverse events are adverse events considered related to at least 1 investigational product by the investigator, including those with unknown relationship."|From the first dose of any study drug up to 30 days after the last dose of any study drug as of the data cut-off date of 15 July 2016; median duration of treatment was 52 weeks in both treatment groups.|Safety population||participants|||Number
662596|NCT01818752|Secondary|European Organisation for Research and Treatment of Cancer Quality of Life Core Module (EORTC QLQ-C30) Global Health Status/Quality of Life (QOL) Scores|"The EORTC QLQ-C30 is a validated self-rating questionnaire including 30 items used to assess the overall quality of life in cancer patients.
It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).
The EORTC QLQ-C30 Global Health Status/QOL scale was scored between 0 and 100, with higher scores indicating better Global Health Status/QOL."|Baseline, weeks 6, 12, 18, 24, 30, 36, 42 and 48|Intent-to treat population with available data at each time point.||units on a scale||Standard Deviation|Mean
662597|NCT01818752|Secondary|Percentage of Participants With ≥ Grade 2 Peripheral Neuropathy|"Neuropathy events were defined as Grade 2 or higher peripheral neuropathy as specified by peripheral neuropathy Standardised Medical Dictionary for Regulatory Activities (MedDRA) Query, narrow (scope) (SMQN) terms.
Peripheral neuropathy was assessed by neurologic exam and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03:
Grade 1: Asymptomatic; Grade 2: Moderate symptoms, limiting instrumental activities of daily living (ADL) Grade 3: Severe symptoms; limiting self-care ADL; Grade 4: Life-threatening consequences, urgent intervention indicated; Grade 5: Death."|From the first dose of any study drug up to 30 days after the last dose of any study drug as of the data cut-off date of 15 July 2016; median duration of treatment was 52 weeks in both treatment groups.|The safety population included all randomized participants who received at least 1 dose of any study treatment (i.e., carfilzomib, bortezomib, melphalan, or prednisone).||percentage of participants||95% Confidence Interval|Number
662598|NCT01818752|Secondary|Complete Response Rate|"Complete response rate was defined as the percentage of participants in each treatment group who achieved a sCR or CR per the IMWG-URC as their best response.
sCR: As for CR, normal serum free light chain (SFLC) ratio and no clonal cells in bone marrow (BM).
CR: No immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and < 5% plasma cells in BM biopsy."|Disease response was assessed every 3 weeks during the first 54 weeks and every 6 weeks thereafter until PD or the data cut-off date of 15 July 2016; median follow-up time was 21.6.and 22.2 months in the bortezomib and carfilzomib arms respectively.|Intent-to-treat population||percentage of participants||95% Confidence Interval|Number
662599|NCT01818752|Secondary|Overall Response Rate|"Disease response was evaluated according to the IMWG-URC using a validated computer algorithm. Overall response was defined as the percentage of participants with a best overall response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR).
sCR: As for CR, normal serum free light chain (SFLC) ratio and no clonal cells in bone marrow (BM).
CR: No immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and < 5% plasma cells in BM biopsy; VGPR: Serum and urine M-protein detectable by immunofixation but not electrophoresis or ≥ 90% reduction in serum M-protein with urine M-protein <100 mg/24 hours. A ≥ 50% reduction in the size of soft tissue plasmacytomas if present at baseline.
PR: ≥ 50% reduction of serum M-protein and reduction in urine M-protein by ≥ 90% or to < 200 mg/24 hours. A ≥ 50% reduction in the size of soft tissue plasmacytomas if present at baseline."|Disease response was assessed every 3 weeks during the first 54 weeks and every 6 weeks thereafter until PD or the data cut-off date of 15 July 2016; median follow-up time was 21.6.and 22.2 months in the bortezomib and carfilzomib arms respectively.|Intent-to-treat population||percentage of participants||95% Confidence Interval|Number
663982|NCT01792830|Secondary|Hyperglycemic Events|Number of subjects that experienced hyperglycemia, defined as blood glucose levels ≥ 140 mg/dl|3 months after discharge||||||
662600|NCT01818752|Secondary|Overall Survival (OS)|"Overall survival (OS) was defined as the time from randomization to the date of death (whatever the cause). Participants who were alive or lost to follow-up as of the data analysis cut-off date were censored on the date the patient was last known to be alive.
Median overall survival was estimated using the Kaplan-Meier method."|From randomization until the data cut-off date of 15 July 2016; median follow-up time for OS was 22.2 and 22.5 months in the bortezomib and carfilzomib arms respectively.|Intent-to-treat population||months||95% Confidence Interval|Median
662601|NCT01818752|Primary|Progression-Free Survival (PFS)|"Progression-free survival was defined as the time from randomization to the earlier of documented disease progression or death due to any cause. PFS was analyzed using Kaplan-Meier methods. The duration of PFS was censored for participants with no baseline and/or post-baseline disease assessments, who started a new anti-cancer therapy before documentation of disease progression or death, death or disease progression after missed disease assessment of 100 consecutive days or longer, or who were alive without documentation of disease progression before the data cutoff date, including lost to follow-up prior to disease progression.
Participants were evaluated for disease response and progression according to the International Myeloma Working Group Uniform Response Criteria (IMWG-URC), determined centrally using a validated computer algorithm in a blinded manner."|From randomization until the data cut-off date of 15 July 2016; median follow-up time for PFS was 21.6.and 22.2 months in the bortezomib and carfilzomib arms respectively.|The intent-to-treat population included all randomized participants.||months||95% Confidence Interval|Median
662602|NCT01818700|Secondary|Patients Global Impression og Change(PGIC)|Number of clinician with categorical change in overall status. PGIC: a participant-rated instrument assessing change in patient's overall status from baseline, on a scale ranging from 1 (very much improved) to 7 (very much worse).|8 week|FAS set: 210. Missing values were imputed by LOCF.||participants|||Number
662603|NCT01818700|Secondary|Clinician Global Impression of Change(CGIC)|Number of clinician with categorical change in overall status. CGIC: a clinician-rated instrument assessing change in clinician's overall status from baseline, on a scale ranging from 1 (very much improved) to 7 (very much worse).|8weeks|FAS set: 210. Missing values were imputed by LOCF.||participants|||Number
662604|NCT01818700|Secondary|Change of EQ-VAS at 8 Weeks of Treatment With Study Drug From Baseline.|EQ-5D Visual Analogue Scale (VAS) in rates the participant's overall health status using values from 0 (worst imaginable) to 100 (best imaginable).|8 week|FAS set: 210. Missing values were imputed by LOCF. Even though 210 subjects were assessed EQ-VAS at visit 1(baseline), 153 Subjects were assessed EQ-VAS at visit 4(8week)||units on a scale||Standard Deviation|Mean
662605|NCT01818700|Secondary|Change in Quality of Life at 8 Week of Treatment With Study Drug From Baseline|"The Euroqol Health Survey (EQ-5D, 3-level) was completed on five dimensions (mobility, self care, usual activities, pain/discomfort and anxiety/depression) to measure health-related quality of life on a scale from 0-1. A higher score indicates better quality of life.
EQ-5D score = 1 - 0.081 - (relevant score by level for the relevant item)-0.269 (only if there is at least one level 3).
Table of scores by level for EQ-5D items mobility(level 1=0, level2=0.069,level 3=0.314), self care(level 1=0, level2=0.104,level 3=0.214), usual activities(level 1=0, level2=0.036,level 3=0.094), pain/discomfort (level 1=0, level2=0.,level 3=0.386) and anxiety/depression(level 1=0, level2=0.071,level 3=0.236)."|8 weeks|FAS set: 210. Missing values were imputed by LOCF. Even though 210 subjects at Visit 1, baseline were assessed EQ-5D questionnaire, At visit 4(8weeks), 153 subjects were assessed EQ-5D questionnaire.||units on a scale||Standard Deviation|Mean
662606|NCT01818700|Secondary|Change of Pain Intensity at 4 Week of Treatment With Study Srug From Baseline.|NRS-Pain scale assessed the severity of a subject's lower back pain on a scale of 0 (No pain) and 10 (Worst possible pain). NRS-Pain scale: Change = mean score at Week 4/ET minus mean score at Baseline.|4 weeks|FAS set: 210. Missing values were imputed LOCF.||units on a scale||Standard Deviation|Mean
662607|NCT01818700|Primary|Change of Pain Intensity* at Week 8 of Treatment With the Study Drug From Baseline|NRS-Pain scale assessed the severity of a subject's lower back pain on a scale of 0 (No pain) and 10 (Worst possible pain). NRS-Pain scale: Change = mean score at Week 8/ET minus mean score at Baseline.|8 weeks|FAS set: 210. Missing values were imputed by LOCF FAS included the data obtained from all subjects who had at least one dose of the study drug and had data of at least one primary efficacy endpoint assessment.||units on a scale||Standard Deviation|Mean
662608|NCT01818596|Secondary|PK Parameter: AUCtau of Tenofovir Diphosphate (TFV-DP) in Peripheral Blood Mononuclear Cell (PBMC) for Participants Enrolled in PK/PD Sub-study|TFV-DP is an active phosphorylated metabolite of tenofovir alafenamide. AUCtau is defined as the concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval). Blood draws for this outcome may have been at the Week 2, 4, or 8 visit.|Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose|Participants who were enrolled in the PK/PD substudy, received at least 1 dose of study drug, and for whom the steady-state PK parameter (AUCtau) of TFV-DP was evaluable were analyzed.||µmol*h/L||Standard Deviation|Mean
662609|NCT01818596|Secondary|PK Parameter: t1/2 of TAF|t1/2 is defined as the estimate of the terminal elimination half-life of the drug. Blood draws for this outcome may have been at the Week 2, 4, or 8 visit.|Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose|Participants in the PK Substudy Analysis Set with available data were analyzed.||hours||Inter-Quartile Range|Median
662610|NCT01818596|Secondary|PK Parameter: AUCtau of TAF|AUCtau is defined as the concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval). Blood draws for this outcome may have been at the Week 2, 4, or 8 visit.|Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose|Participants in the PK Substudy Analysis Set with available data were analyzed.||ng*h/mL||Standard Deviation|Mean
662611|NCT01818596|Secondary|PK Parameter: λz of TAF|λz is defined as the terminal elimination rate constant. Blood draws for this outcome may have been at the Week 2, 4, or 8 visit.|Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose|Participants in the PK Substudy Analysis Set with available data were analyzed.||1/hour||Standard Deviation|Mean
662612|NCT01818596|Secondary|PK Parameter: Tlast of TAF|Tlast is defined as the time of Clast. Blood draws for this outcome may have been at the Week 2, 4, or 8 visit.|Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose|Participants in the PK Substudy Analysis Set with available data were analyzed.||hours||Inter-Quartile Range|Median
662613|NCT01818596|Secondary|PK Parameter: Clast of TAF|Clast is defined as the last observable concentration of drug. Blood draws for this outcome may have been at the Week 2, 4, or 8 visit.|Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose|Participants in the PK Substudy Analysis Set with available data were analyzed.||ng/mL||Standard Deviation|Mean
662614|NCT01818596|Secondary|PK Parameter: Tmax of TAF|Tmax is defined as the time of Cmax. Blood draws for this outcome may have been at the Week 2, 4, or 8 visit.|Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose|Participants in the PK Substudy Analysis Set with available data were analyzed.||hours||Inter-Quartile Range|Median
662615|NCT01818596|Secondary|Pharmacokinetic (PK) Parameter: Cmax of TAF|Cmax is defined as the maximum concentration of drug. Blood draws for this outcome may have been at the Week 2, 4, or 8 visit.|Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose|Participants in the PK Substudy Analysis Set (enrolled in the PK/PD substudy, received at least 1 dose of study drug, and for whom steady-state PK parameters were available) with available data were analyzed.||ng/mL||Standard Deviation|Mean
662616|NCT01818596|Secondary|Percentage of Participants Achieving HIV-1 RNA < 50 Copies/mL at Week 24|The percentage of participants achieving HIV-1 RNA < 50 Copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 24|Full Analysis Set: participants were enrolled and received at least 1 dose of study drug||percentage of participants|||Number
662617|NCT01818596|Secondary|Percentage of Participants Experiencing Adverse Events or Graded Laboratory Abnormalities|"Adverse events (AEs) and graded laboratory abnormalities occurring during the E/C/F/TAF treatment period were summarized across the participant population. A participant was counted once if they had a qualifying event.
Data were collected for all participants through the Week 24 visit; additional data are included for participants who had passed the Week 24 visit."|Baseline to Week 24 Data Cut (average 42 weeks)|Safety Analysis Set||percentage of participants|||Number
662618|NCT01818596|Secondary|Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio (μg/g) at Week 24|Urine beta-2-microglobulin is a renal biomarker which is used to detect drug-induced kidney injury.|Baseline; Week 24|Participants in the Safety Analysis Set with available data at the respective time point were analyzed.||percentage change||Inter-Quartile Range|Median
662619|NCT01818596|Secondary|Percent Change From Baseline in Retinol Binding Protein (RBP) to Creatinine Ratio (μg/g) at Week 24|Urine RBP is a renal biomarker which is used to detect drug-induced kidney injury.|Baseline; Week 24|Participants in the Safety Analysis Set with available data at the respective time point were analyzed.||percentage change||Inter-Quartile Range|Median
662620|NCT01818596|Primary|Change From Baseline in eGFR Calculated by the CKD-EPI Method Based on Serum Creatinine (eGFR_CKD-EPI,Creatinine) at Week 24|eGFR is a measurement of the kidney's ability to filter blood. The eGFR_CKD-EPI,creatinine method is adjusted for age, race, and sex.|Baseline; Week 24|Participants in the Safety Analysis Set with available data at the respective time point were analyzed.||mL/min/1.73 m^2||Inter-Quartile Range|Median
662621|NCT01818596|Secondary|Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) at Week 24|P1NP is a biomarker of bone turnover.|Baseline; Week 24|Participants in the Safety Analysis Set with available data at the respective time point were analyzed.||percentage change||Inter-Quartile Range|Median
662622|NCT01818596|Secondary|Percent Change From Baseline in C-type Collagen Sequence (CTX) at Week 24|CTX is a biomarker of bone turnover.|Baseline; Week 24|Participants in the Safety Analysis Set with available data at the respective time point were analyzed.||percentage change||Inter-Quartile Range|Median
662623|NCT01818596|Secondary|Change From Baseline in Actual GFR (aGFR) of E/C/F/TAF for Participants Enrolled in the PK/PD Substudy|aGFR was directly measured using iohexol plasma clearance (CLiohexol).|Baseline; Week 2, 4, or 8; Week 24|Participants in the Pharmacodynamic (PD) Substudy Analysis Set (enrolled in the pharmacokinetic (PK)/PD substudy, received at least 1 dose of study drug, and had baseline and at least 1 postbaseline assessment for aGFR assessed by CLiohexol) with available data at the respective time point were analyzed.||mL/min||Standard Deviation|Mean
662624|NCT01818596|Primary|Change From Baseline in eGFR Calculated by the Chronic Kidney Disease Epidemiology Collaboration Method Based on Cystatin C (eGFR_CKD-EPI,cysC) at Week 24|eGFR is a measurement of the kidney's ability to filter blood. The eGFR_CKD-EPI,cysC method is adjusted for age and sex.|Baseline; Week 24|Participants in the Safety Analysis Set with available data at the respective time point were analyzed.||mL/min/1.73 m^2||Inter-Quartile Range|Median
662625|NCT01818596|Primary|Change From Baseline in the Estimated Glomerular Filtration Rate Calculated by the Cockcroft-Gault Formula (eGFR_CG) at Week 24|eGFR is a measurement of the kidney's ability to filter blood.|Baseline; Week 24|Participants in the Safety Analysis Set (enrolled and received at least 1 dose of study drug) with available data at the respective time point were analyzed.||mL/min||Inter-Quartile Range|Median
662626|NCT01818414|Secondary|Complications|Incidence of surgical complications related to D&E|Day 1|||participants|||Number
662627|NCT01818414|Secondary|Number of Providers With Overall Satisfaction|Provider overall satisfaction with cervical preparation|Day 1|||providers|||Number
662628|NCT01818414|Secondary|Number of Participants With Postoperative Satisfaction|Patient postoperative satisfaction with cervical preparation method|Day 1|||participants|||Number
662629|NCT01818414|Secondary|Patient Pain|"Change in pain from baseline to immediately preoperatively using a 100-mm Visual Analogue Scale (100-mm Visual Analogue Scale with 0 indicating no pain and 100 indicating worst pain in my life)"|Day 1|||mm||Standard Deviation|Mean
662630|NCT01818414|Primary|Operative Time|The primary outcome will be operative time. Operative time will be measured from initial passage of an instrument into the uterus to start the D&E. The end of operative time will be measured by the removal of the last instrument from the uterus to complete the D&E.|Day 1 of the study|||minutes||Standard Deviation|Mean
662723|NCT01815918|Secondary|Blinding Assessment|Throughout each patient's study participation, the patient and the data collector will be asked to guess their treatment status. This helps ascertain if there is an association between blinding status, treatment effect and the depression measure.|one month and up to 3 months following surgery|Outcome could not be analyzed because patients could not be reached to collect data at one month and up to 3 months following surgery.|||||
662631|NCT01818336|Primary|Negative Predictive Value|The primary endpoint was the negative predictive value (NPV), which was estimated as p = percentage of n history-positive subjects with negative skin tests from the Penicillin Allergy Skin Test Kit (as confirmed with an overall negative result for the skin puncture/intradermal testing) who do not experience an IgE-dependent hypersensitivity reaction within 72 hours of the oral amoxicillin challenge.|72 hours|The Intent-to-Treat Population; all subjects with valid skin testing performed (ie, administered all components of the penicillin skin test kit and the histamine/control results were valid), who had negative intradermal skin tests with all 3 Kit reagents, and who received the oral amoxicillin challenge||percentage of participants||95% Confidence Interval|Number
662632|NCT01818297|Secondary|Worst Back Pain|Compare the average improvement in worst back pain from Baseline to Month 3 between the Treatment and Control groups. Subjects reported worst back pain (0 (no pain) - 10 (worst pain)) during the Baseline and Blinded Phase (Month 3) periods. Change was calculated as Baseline - Month 3, with a positive change indicating improvement in worst back pain.|Baseline to 3 months|||units on a scale||Standard Deviation|Mean
662633|NCT01818297|Secondary|Quality of Life: Mental|Compare the average change in quality of life (as measured by Short Form Health Survey (SF36 v2): Mental component score (MCS)) from Baseline to Month 3 between subjects in the Treatment and Control groups. The MCS ranges from 0 (worst possible mental quality of life) to 100 (best possible mental quality of life). Change was calculated as Month 3 - Baseline, with a positive difference indicating improvement in mental quality of life. Subjects with missing Baseline and/or Month 3 SF-36: MCS assessments were counted as no change (Month 3 - Baseline = 0).|Baseline to 3 months|||units on a scale||Standard Deviation|Mean
662634|NCT01818297|Secondary|Quality of Life: Physical|Compare the average change in quality of life (as measured by Short Form Health Survey (SF36 v2): Physical component score (PCS)) from Baseline to Month 3 between subjects in the Treatment and Control groups. The PCS ranges from 0 (worst possible physicial quality of life) to 100 (best possible physical quality of life). Change was calculated as Month 3 - Baseline, with a positive difference indicating improvement in physical quality of life. Subjects with missing Baseline and/or Month 3 SF-36: PCS assessments were counted as no change (Month 3 - Baseline = 0).|Baseline to 3 months|||units on a scale||Standard Deviation|Mean
662635|NCT01818297|Secondary|Subject Satisfaction|Compare difference in number of subjects satisfied with therapy between the Treatment and Control groups at Month 3. Subjects who reported they were very or somewhat satisfied with the therapy were counted as satisfied. Subjects with no satisfaction response were excluded from the analysis.|3 months|The analysis population includes all randomized subjects, with the exception of one subject in the Control group who did not have a satisfaction value. This subject was excluded from the analysis.||Participants|||Count of Participants
662636|NCT01818297|Secondary|Functional Disability|Compare the difference in average improvement in disability (as measured by Oswestry Disability Index (ODI)) from Baseline to Month 3 between the Treatment and Control groups. ODI ranges from 0% (no disability) -100% (greatest disability). Change is calculated as Baseline - Month 3 with a positive change indicating improvement in disability. Subjects with missing Baseline and/or Month 3 ODI assessments were counted as no change (Baseline - Month 3 = 0).|Baseline to 3 months|||units on a scale||Standard Deviation|Mean
662637|NCT01818297|Primary|Number of Back Pain Responders (Subjects Who Achieve at Least a 50% Reduction in Average Back Pain With no Increase in Prescription Pain Medications) From Baseline to Month 3 Post-device Activation.|Number of responders in Treatment and Control groups. Subjects reported typical back pain (0=no pain, 10=worst pain) during the Baseline (BL) and Blinded Phase (M3) periods. Percentage reduction in average back pain was calculated as (BL-M3)/BL. Subjects with at least a 50% reduction in average back pain between Baseline and Month 3, with no increase in prescribed pain medications, were considered responders.|Baseline to 3 months|||Participants|||Count of Participants
662638|NCT01818141|Primary|C. Difficile Vegetative Cell Reduction of at Least 2 Log 10 Colony Forming Units (CFU)/g of Stool|The number and percentage of patients who achieved at least 2 log10 CFU/g of stool reductions of Clostridium difficile vegetative cells from baseline by the end of therapy (days 10-13)|day 10-13|||Participants|||Count of Participants
662639|NCT01818141|Primary|C. Difficile Spore Reduction of at Least 2 Log 10 Colony Forming Units (CFU)/g of Stool|The number and percentage of patients who achieved at least 2 log10 colony forming units (CFU)/g of stool reductions of Clostridium difficile spores from baseline by the end of therapy (days 10-13).|day 10-13|||Participants|||Count of Participants
662640|NCT01817907|Secondary|Arousal Threshold (cmH2O)|Subjects will have an epiglottic pressure catheter placed during their sleep studies. We will use the swing in the epiglottic pressure trace just prior to arousal to calculate the respiratory drive stimulus that is associated with an a respiratory induced arousal.|Participants will be assessed on 2 nights over an average period of 2 weeks.|two subjects were excluded from analysis because of excessive number of artifacts||cmH2O||Standard Deviation|Mean
662641|NCT01817907|Primary|Apnea-Hypopnea Index|The Apnea-Hypopnea Index (AHI) is an index of sleep apnea severity that encompasses the frequency of apneas (cessations in breathing) and hypopneas (reductions in airflow).|Participants will be assessed on 2 nights over an average period of 2 weeks.|two subjects were excluded from analysis because of excessive number of artifacts||events/hour||Standard Error|Mean
662642|NCT01817855|Secondary|Summary of Pharmacokinetic Parameters (Cmin)|"Summary of pharmacokinetic parameters of AZD7624 after multiple once daily dose administration in cohorts 4,5,6 and multiple twice daily administration in cohorts 1,2 and 3, on Days 7, 8 or 9. Results are presented for cohort 1,2,3,4,5 with SPIRA device and for cohort 6 with ADI device (test device).
Number of Participants Analyzed is based on the available data for the used device and for the day that PK measurements were taken."|PK concentration was measured at 0, 15min, 30min, 45min, 1hr, 2hr, 4hr, 6hr, 9hr, 12hr, 18hr and 24hr post dose on Day 7 for cohort 6, Day 8 for cohorts 1,4 and 5 and on Day 9 for cohorts 2 and 3.|PK analysis set||nmol/L||Geometric Coefficient of Variation|Geometric Mean
662643|NCT01817855|Secondary|Summary of Pharmacokinetic Parameters (Cmax)|"Summary of pharmacokinetic parameters of AZD7624 after multiple once daily dose administration in cohorts 4,5,6 and multiple twice daily administration in cohorts 1,2 and 3, on Days 7, 8 or 9. Results are presented for cohort 1,2,3,4,5 with SPIRA device and for cohort 6 with ADI device (test device).
Number of Participants Analyzed is based on the available data for the used device and for the day that PK measurements were taken."|PK concentration was measured at 0, 15min, 30min, 45min, 1hr, 2hr, 4hr, 6hr, 9hr, 12hr, 18hr and 24hr post dose on Day 7 for cohort 6, Day 8 for cohorts 1,4 and 5 and on Day 9 for cohorts 2 and 3.|PK analysis set||nmol/L||Geometric Coefficient of Variation|Geometric Mean
662644|NCT01817855|Secondary|Summary of Pharmacokinetic Parameters (AUC(0-tau) )|"Summary of pharmacokinetic parameters of AZD7624 after multiple once daily dose administration in cohorts 4,5,6 and multiple twice daily administration in cohorts 1,2 and 3, on Days 7, 8 or 9.
*AUC(0-tau) = AUC(0-last) where for cohorts 2,3,4,5 and 6 tau=24 hours and for cohort 1, tau=12 hours .
Results are presented for cohort 1,2,3,4,5 with SPIRA device and for cohort 6 with ADI device (test device).
Number of Participants Analyzed is based on the available data for the used device and for the day that PK measurements were taken."|PK concentration was measured at 0, 15min, 30min, 45min, 1hr, 2hr, 4hr, 6hr, 9hr, 12hr, 18hr and 24hr post dose on Day 7 for cohort 6, Day 8 for cohorts 1,4 and 5 and on Day 9 for cohorts 2 and 3.|PK analysis set||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
662645|NCT01817855|Primary|Adverse Events|Summary of number of subjects who had at least one adverse event in any category (Safety analysis set)|Up to 24 days|||Participants|||Number
662646|NCT01817790|Secondary|Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Other Symptoms|"MiniRQLQ is a 14-item, disease-specific instrument for assessing the impact of allergic rhinitis on activities of daily living and overall well-being. Other Symptoms is one of the domains of Mini RQLQ scores. Participants scored their degree of impairment on a seven-point scale (0 = not troubled, 6 = extremely troubled)."|Baseline to 14 days|"All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population. For analysis of other symptoms, data of one participant each from the two groups are unavailable."||Score on a scale||Standard Deviation|Mean
662647|NCT01817790|Secondary|Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Eye Symptoms|"MiniRQLQ is a 14-item, disease-specific instrument for assessing the impact of allergic rhinitis on activities of daily living and overall well-being. Eye Symptoms is one of the domains of Mini RQLQ scores. Participants scored their degree of impairment on a seven-point scale (0 = not troubled, 6 = extremely troubled)."|Baseline to 14 days|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population. For analysis of eye symptoms, data of one participant each from the two groups are unavailable.||Score on a scale||Standard Deviation|Mean
662648|NCT01817790|Secondary|Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Nose Symptoms|"MiniRQLQ is a 14-item, disease-specific instrument for assessing the impact of allergic rhinitis on activities of daily living and overall well-being. Nose Symptoms is one of the domains of Mini RQLQ scores. Participants scored their degree of impairment on a seven-point scale (0 = not troubled, 6 = extremely troubled)."|Baseline to 14 days|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population. For analysis of nose symptoms, data of one participant each from the two groups are unavailable.||Score on a scale||Standard Deviation|Mean
662649|NCT01817790|Secondary|Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Practical Problems|MiniRQLQ is a 14-item, disease-specific instrument for assessing the impact of allergic rhinitis on activities of daily living and overall well-being. 'Practical Problems' is one of the domains of Mini RQLQ scores. Participants scored their degree of impairment on a seven-point scale (0 = not troubled, 6 = extremely troubled).|Baseline to 14 days|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population.||Score on a scale||Standard Deviation|Mean
662650|NCT01817790|Secondary|Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Activities|MiniRQLQ is a 14-item, disease-specific instrument for assessing the impact of allergic rhinitis on activities of daily living and overall well-being. Activity limitations is one of the domains of Mini RQLQ scores. Participants scored their degree of impairment on a seven-point scale (0 = not troubled, 6 = extremely troubled).|Baseline to 14 days|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population.||Score on a scale||Standard Deviation|Mean
662651|NCT01817790|Secondary|Mean Changes From Baseline in Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) Scores|MiniRQLQ is a 14-item, disease-specific instrument for assessing the impact of allergic rhinitis on activities of daily living and overall well-being. It measures five domains of functional impairment that are most important to subjects with SAR: practical problems, nasal symptoms, eye symptoms, activity limitations, and other symptoms. Participants scored their degree of impairment on a seven-point scale. (0 - 6). Mini RQLQ final score is the average of sub-scales, ranges from 0 (best possible outcome) to 6 (worst possible outcome).|Baseline to 14 days|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population. For analysis of nose symptoms, eye symptoms, and other symptoms, data of one participant each from the two groups are unavailable.||Score on a scale||Standard Deviation|Mean
662652|NCT01817790|Secondary|Mean Change in Objective Assessment of Conjunctival Redness|Conjunctival redness was evaluated as a clinical sign of SAR by the investigator. Scoring of severity was rated according to a 4-point scale: 0 = normal; 1 = Slightly pink; 2 = Moderately pink, some dilation; 3 = Intense red vessels, dilated.|Baseline to 14 days|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population.||Score on a scale||Standard Deviation|Mean
662653|NCT01817790|Secondary|End-of-treatment Assessment of Response to Therapy for Ocular Symptoms|Overall response to therapy assessment was done using a 7-point categorical scale in which participants rated their response to therapy as follows: +3 = Significantly Improved; +2 = Moderately Improved; +1 = Mildly Improved; 0 = No Change; -1= Mildly Worse; -2 = Moderately Worse; -3 = Significantly Worse.|Day 14|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population. In this outcome measure, in Fluticasone propionate group 313/314 participants, and in the placebo group 309/312 participants provided responses.||Participants|||Number
662724|NCT01815918|Secondary|Pain Scores and Opioid Consumption|Pain scores (rated on a scale of 0-10) will be taken throughout study participation. We will also record analgesic use to see if patients who received hydrocortisone needed fewer pain killers to control their postoperative pain.|one month and up to 3 months following surgery|Outcome could not be analyzed because patients could not be reached to collect data at one month and up to 3 months following surgery.|||||
662654|NCT01817790|Secondary|Mean Change From Baseline in Reflective Nasal Congestion Symptom Score (rNCSS)|The rNCSS is a participant perceived evaluation of overall congestion symptom severity (evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe) which was completed once in the evening (PM), and once in the morning (AM). rNCSS is defined as the average of the PM rNCSS and the AM rNCSS of the next day prior to AM dosing. The mean change from baseline in rNCSS (daily, AM, PM)was calculated as the subject's treatment period mean (over 14 days; from Day 0 PM to Day 14 AM) minus the baseline period (placebo run-in) mean.|Baseline to 14 days|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population.||Score on a scale||Standard Deviation|Mean
662655|NCT01817790|Secondary|Mean Change From Baseline in AM Pre-dose Instantaneous Total Ocular Symptom Scores (iTOSS)|Instantaneous total ocular symptom scores (iTOSS) assessments are self perceived evaluation of symptom severity immediately before the dose (how the subject feels at that point in time). iTOSS (possible score of 0-9) is the sum of 3 individual participant-assessed symptom scores for eye itching/burning, eye tearing/watering, and eye redness each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe. Mean changes from baseline were calculated as treatment period iTOSS minus baseline iTOSS.|Baseline to 14 days|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population.||Score on a scale||Standard Deviation|Mean
662656|NCT01817790|Secondary|Mean Change From Baseline in Individual PM Reflective Ocular Symptom Scores for Eye Redness|The PM Reflective Ocular Symptom Score was assessed individually for eye redness using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. For evaluation, subjects completed the scoring in the evening, 12 hours post morning nasal spray use. The mean change from baseline in PM Reflective Ocular Symptom Score (eye redness) was calculated as the subject's treatment period mean (over 14 days) minus the baseline period (placebo run-in) mean.|Baseline to 14 days|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population.||Score on a scale||Standard Deviation|Mean
662657|NCT01817790|Secondary|Mean Change From Baseline in Individual AM Reflective Ocular Symptom Scores for Eye Redness|The AM Reflective Ocular Symptom Score was assessed individually for eye redness using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. For evaluation, subjects completed the scoring in the morning, prior to nasal spray use. The mean change from baseline in AM Reflective Ocular Symptom Score (eye redness) was calculated as the subject's treatment period mean (over 14 days) minus the baseline period (placebo run-in) mean.|Baseline to 14 days|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population.||Score on a scale||Standard Deviation|Mean
662658|NCT01817790|Secondary|Mean Change From Baseline in Individual PM Reflective Ocular Symptom Scores for Eye Tearing/Watering|The PM Reflective Ocular Symptom Score was assessed individually for eye tearing/watering using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. For evaluation, subjects completed the scoring in the evening, 12 hours post morning nasal spray use. The mean change from baseline in PM Reflective Ocular Symptom Score (eye tearing/watering) was calculated as the subject's treatment period mean (over 14 days) minus the baseline period (placebo run-in) mean.|Baseline to 14 days|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population.||Score on a scale||Standard Deviation|Mean
662659|NCT01817790|Secondary|Mean Change From Baseline in Individual AM Reflective Ocular Symptom Scores for Eye Tearing/Watering|The AM Reflective Ocular Symptom Score was assessed individually for eye tearing/watering using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. For evaluation, subjects completed the scoring in the morning, prior to nasal spray use. The mean change from baseline in AM Reflective Ocular Symptom Score (eye tearing/watering) was calculated as the subject's treatment period mean (over 14 days) minus the baseline period (placebo run-in) mean.|Baseline to 14 days|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population.||Score on a scale||Standard Deviation|Mean
662660|NCT01817790|Secondary|Mean Change From Baseline in Individual PM Reflective Ocular Symptom Scores for Eye Itching/Burning|The PM Reflective Ocular Symptom Score was assessed individually for eye itching/burning using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. For evaluation, subjects completed the scoring in the evening, 12 hours post morning nasal spray use. The mean change from baseline in PM Reflective Ocular Symptom Score (eye itching and burning) was calculated as the subject's treatment period mean (over 14 days) minus the baseline period (placebo run-in) mean.|Baseline to 14 days|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population.||Score on a scale||Standard Deviation|Mean
662661|NCT01817790|Secondary|Mean Change From Baseline in Individual AM Reflective Ocular Symptom Scores for Eye Itching/Burning|The AM Reflective Ocular Symptom Score was assessed individually for eye itching/burning using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. For evaluation, subjects completed the scoring in the morning, prior to nasal spray use. The mean change from baseline in AM Reflective Ocular Symptom Score (eye itching and burning) was calculated as the subject's treatment period mean (over 14 days) minus the baseline period (placebo run-in) mean.|Baseline to 14 days|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population.||Score on a scale||Standard Deviation|Mean
662662|NCT01817790|Secondary|Mean Change From Baseline in PM rTOSS|rTOSS is the sum of 3 individual participant-assessed symptom scores (eye itching/ burning, eye tearing/watering, and eye redness), each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. For PM rTOSS, subjects completed rTOSS in the evening, 12 hours post morning nasal spray use. The mean change from baseline in PM rTOSS was calculated as the subject's treatment period mean (over 14 days) minus the baseline period (placebo run-in) mean.|Baseline to 14 days|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population.||Score on a scale||Standard Deviation|Mean
662663|NCT01817790|Secondary|Mean Change From Baseline in AM rTOSS|rTOSS is the sum of 3 individual participant-assessed symptom scores (eye itching/ burning, eye tearing/watering, and eye redness), each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. For AM rToss, subjects completed rTOSS in the morning (AM score: prior to nasal spray use). The mean change from baseline in AM rTOSS was calculated as the subject's treatment period mean (over 14 days) minus the baseline period (placebo run-in) mean.|Baseline to 14 days|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population.||Score on a scale||Standard Deviation|Mean
662664|NCT01817790|Primary|Mean Change From Baseline in Reflective Total Ocular Symptom Score (rTOSS)|The Reflective Total Ocular Symptom Score (rTOSS) is the sum of 3 individual participant-assessed symptom scores (eye itching/burning, eye tearing/watering, and eye redness), each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. Subjects completed rTOSS in the evening (PM rTOSS; 12 hours post morning nasal spray use) and once in the morning (AM score: prior to nasal spray use). Daily (i.e. during one dosing interval) rTOSS is defined as the average of the PM rTOSS and the AM rTOSS of the next day prior to AM dosing. The mean change from baseline in (daily, AM, PM) TOSS was calculated as the subject’s treatment period mean (over 14 days; from Day 0 PM to Day 14 AM) minus the baseline period (placebo run-in) mean.|Baseline to 14 days|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population.||Score on a scale||Standard Deviation|Mean
662665|NCT01817777|Secondary|Number of Participants Withdrawn From the Study Due to the Following Reasons: Withdrawal of Informed Consent; Lost to Follow-up|The number of participants who voluntarily discontinued participation in the study at any time or who were withdrawn by the investigator for pre-defined reasons was summarized.|Week 28|Observational Population: all participants enrolled into the study. If an enrolled participant withdrew from the study prior to the Week 8 visit, all available data on the participant was included in the Observational Population.||Participants|||Number
662666|NCT01817777|Secondary|Number of Participants Who Missed Metformin Days/Doses for the Indicated Reasons|The number of particiapnts who missed days or doses of metformin was summarized.|Week 28|Per Protocol Population||Participants|||Number
662667|NCT01817777|Secondary|Number of Participants Who Preferred Their Treatment Regimens (Interventional Arm Treatment [Large or Small Pack Metformin]) to How They Previously Took Their Medication|Number of participants who preferred their treatment regimens (interventional arm treatment [large or small pack metformin]) to how they previously took their medication are presented.|Week 28|Per Protocol Population||Participants|||Number
662668|NCT01817777|Secondary|Number of Participants Who Required a Non-routine Health Care Professional Visit for Diabetes|The number of participants who visited a health care professional for diabetes management during the study was summarized.|Week 28|Per Protocol Population||Participants|||Number
662669|NCT01817777|Secondary|Number of Participants With Diabetes Disease Management Modifications|Throughout the duration of the study, participants remained on their recommended metformin dosing regimens, unless a change in metformin dose was prescribed by their physician. The number of participants who received additional diabetes therapy for the management of diabetes was summarized.|Week 28|Per Protocol Population||Participants|||Number
662670|NCT01817777|Secondary|Number of Participants Who Took Zero Metformin Pills for the Indicated Number of Days|The number of days on which no metformin pills were taken by participants was summarized.|Week 28|Per Protocol Population||Participants|||Number
662671|NCT01817777|Secondary|Mean Percent Compliance Throughout the Observational Phase, Per Treatment They Were Randomized to in the Interventional Phase|Compliance was estimated during the 8-week Observational Phase for usual metformin treatment. During the Observational Phase, compliance was measured by monitoring the number of pill dispensed and the return of the pills or tablets.|From enrollment to Week 8|Per Protocol Population||Percent compliance||Standard Deviation|Mean
662672|NCT01817777|Secondary|Mean Percent Compliance Throughout the Interventional Phase|Compliance for the study was estimated as a percentage, with the denominator defined as the number of pills dispensed by the pharmacist and the numerator defined as the number of pills taken, accounting for remaining pills at subsequent pharmacy visits.|From Randomization to Week 28|Per Protocol Population||Percent compliance||Standard Deviation|Mean
662673|NCT01817777|Primary|Change From Baseline in HbA1c Values at Week 28|HbA1c was tested with a point-of-care device, which required a finger prick to obtain blood and provided an immediate result upon analysis in the device. HbA1c was tested at pharmacy visits corresponding to three time points: enrollment (Week 0), Baseline (Week 8), and End of Study (Week 28). The difference in the mean change from Baseline was to be calculated between the treatment arms (small pack minus large pack), and the 2-sided 95% confidence interval for the difference in mean change in HbA1c was to be calculated. However, because the study was terminated early, and the sample size was reduced, the statistical hypotheses defined in the protocol were not tested due to insufficient power. Therefore, the final analyses were limited to descriptive statistics. The percentage HbA1c is a measure of how much of the hemoglobin in the blood has become glycated (chemically bounded to glucose).|Baseline (Week 8) and Week 28|Per Protocol Population: all participants in the Intent-to-Treat Population (randomly assigned to treatment and who received >= 1 dose [or any portion of a dose] of study medication and had an HbA1c test at Week 8) who did not have a protocol violation||Percentage||Standard Deviation|Mean
662674|NCT01817764|Secondary|Change From Baseline in Trough FEV1 on Day 85|Trough FEV1 on Day 85 is defined as the mean of the FEV1 values obtained 23 and 24 hours after morning dosing/11 and 12 hours after evening dosing on Day 84. Change from Baseline is calculated as the Day 85 value minus the Baseline value. Analysis was performed using a repeated measures model with covariates of treatment, Baseline (mean of the two assessments made 30 minutes and 5 minutes pre-dose on Day 1), smoking status, day, and day by Baseline and day by treatment interactions.|Baseline and Day 85|ITT Population. Only those participants with analyzable data at the indicated time point were assessed.||Liters||Standard Error|Least Squares Mean
662725|NCT01815918|Secondary|Hydrocortisone's Effect on Depression|Elevated IL-6 has been linked to post-operative depression following total knee replacement surgery. Patients will be administered the patient health questionnaire (PHQ-9) one month and 3 months following surgery to assess their well-being.|one month and up to 3 months following surgery|Outcome could not be analyzed because patients could not be reached to collect data at one month and up to 3 months following surgery.|||||
662675|NCT01817764|Primary|Change From Baseline in 24-hour Weighted-mean Serial FEV1 on Treatment Day 84|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Weighted mean is calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5 and 15 minutes and 1, 3, 6, 9, 12 (pre-evening dose), 13, 15, 18, 23, and 24 hours after the morning dose. Change from Baseline was calculated as the value at Day 84 minus the value at Baseline. Analysis was performed using an analysis of covariance of treatment, Baseline (mean of the two assessments made 30 minutes and 5 minutes pre-dose on Day 1), and smoking status. par.=participants.|Baseline and Day 84|Intent-to-Treat (ITT) Population: all par. randomized to treatment who received >=1 dose of randomized study medication in the treatment period. Only par. with analyzable data at the indicated time point were assessed, but all par. without missing covariate information and with >=1 post-Baseline measurement were included in the analysis.||Liters||Standard Error|Least Squares Mean
662676|NCT01817725|Secondary|Anti-HBs Seropositivity||2 years|||Participants|||Count of Participants
662677|NCT01817725|Primary|Change in HBsAg Levels From Baseline to 2 Years|The difference of HBsAg levels at the end of follow up (2 years) and baseline|2 years|||log IU/ml||Standard Deviation|Mean
662678|NCT01816776|Secondary|Epworth Sleepiness Scale (ESS) Change From Baseline at 6 Months|Change in ESS = Month 6 score - Baseline score. The ESS is an assessment to measure a subject's general level of daytime sleepiness. Scores can range from 0-24, with higher scores indicating higher level of daytime sleepiness.|6 months|"Per protocol: excludes patients who did not meet major entry criteria, had therapy programmed to off at the 6-month visit, did not have 6-month PSG results or had unsuccessful implant attempt."||units on a scale||95% Confidence Interval|Mean
662679|NCT01816776|Secondary|Oxygen Desaturation Index 4% (ODI4) Change From Baseline at 6 Months|Change in ODI4 = Month 6 index - Baseline index. The Oxygen Desaturation Index 4% is a measurement of the number of times per hour of sleep that the blood's oxygen level drops ≥4%.|6 months|"Per protocol: excludes patients who did not meet major entry criteria, had therapy programmed to off at the 6-month visit, did not have 6-month PSG results or had unsuccessful implant attempt."||Events/hour||95% Confidence Interval|Mean
662680|NCT01816776|Secondary|The Proportion of Participants Experiencing a Marked or Moderate Improvement in Patient Global Assessment at 6 Months|"The proportion of subjects with a moderate or marked improvement in the Patient Global Assessment from baseline to the 6 month visit"|6 months|"Per protocol: excludes patients who did not meet major entry criteria, had therapy programmed to off at the 6-month visit, did not have 6-month PSG results or had unsuccessful implant attempt. Note: 1 Control subject did not provide a response and is excluded from analysis."||Participants|||Count of Participants
662681|NCT01816776|Secondary|Rapid Eye Movement (REM) Sleep Change From Baseline at 6 Months|Change in REM = Month 6 percentage - Baseline percentage. Rapid Eye Movement (REM) is a sleep stage. A higher percentage of sleep in REM is a measure of better sleep quality.|6 months|"Per protocol: excludes patients who did not meet major entry criteria, had therapy programmed to off at the 6-month visit, did not have 6-month PSG results or had unsuccessful implant attempt."||percentage of sleep||95% Confidence Interval|Mean
662682|NCT01816776|Secondary|Arousal Index (ArI) Change From Baseline at 6 Months|Change in ArI = Month 6 index - Baseline index. The Arousal Index is a measurement used to indicate the number of times per hour of sleep that sleep is disrupted.|6 months|"Per protocol: excludes patients who did not meet major entry criteria, had therapy programmed to off at the 6-month visit, did not have 6-month PSG results or had unsuccessful implant attempt."||Events/hour||95% Confidence Interval|Mean
662683|NCT01816776|Secondary|Apnea-Hypopnea Index (AHI) Change From Baseline at 6 Months|Change in AHI = Month 6 index - Baseline index. The Apnea-Hypopnea Index is a measurement used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep.|6 months|"Per protocol: excludes patients who did not meet major entry criteria, had therapy programmed to off at the 6-month visit, did not have 6-month PSG results or had unsuccessful implant attempt."||Events/hour||95% Confidence Interval|Mean
662684|NCT01816776|Secondary|Central Apnea Index (CAI) Change From Baseline at 6 Months|Change in CAI = Month 6 index - Baseline index. The central apnea index is a measurement used to indicate the severity of central sleep apnea. It is represented by the number of central apnea events per hour of sleep.|6 months|"Per protocol: excludes patients who did not meet major entry criteria, had therapy programmed to off at the 6-month visit, did not have 6-month polysomnogram (PSG) results or had unsuccessful implant attempt."||Events/hour||95% Confidence Interval|Mean
662685|NCT01816776|Primary|Freedom From Related Serious Adverse Events Within 12 Months|Freedom from serious adverse events (SAEs) associated with the implant procedure, the remede System, or the delivered therapy at 12 months post therapy initiation visit.|12 months|Intent-to-treat. The study protocol pre-specified that randomized groups be combined to assess freedom from related serious adverse events within 12 months.||Participants|||Count of Participants
662686|NCT01816776|Primary|The Proportion of Participants Experiencing a Reduction in Apnea-hypopnea Index (AHI)|Comparison of the proportion of subjects in the Treatment group achieving a 50% or greater reduction in AHI from baseline to 6 months compared to the Control group.|6 months|The population analyzed included all randomized participants who had a 6 month assessment. In addition, Treatment group subjects who did not have a 6 month assessment for reasons related to implant, device or delivered therapy were included as not achieving the endpoint.||Participants|||Count of Participants
662687|NCT01816685|Primary|Presence of Postoperative Delirium|Assessments for delirium were made on postoperative day 2 using the Confusion Assessment Method (CAM) Diagnostic Algorithm. This binary tool identifies the presence or absence of delirium|Postoperative day 2|||participants|||Number
662688|NCT01816685|Primary|Presence of Postoperative Delirium|Assessments for delirium were made on postoperative day 2 using the Delirium Rating Scale-Revised-98 (DRS-R-98) diagnostic and assessment tool. The DRS-R-98 is a 16-item clinician-rated scale that consists of a severity score (maximum score 39, minimum 0) made up of items that can be used for repeated serial measurements and a total scale score (maximum score 46, minimum 0) that includes the severity score plus three diagnostic items (7 additional possible points) used for initial ratings. Items represent symptoms that are rated on a scale of 0 to 3 points, with text descriptions for each point. Higher scores on the scale represents a larger number of delirium symptoms or increased severity of those symptoms.|Postoperative day 2|||units on a scale||Standard Deviation|Mean
662689|NCT01816477|Secondary|Mean Daily Pain Score|Pain was measured by a visual analogue scale (VAS) with pre-set markings from 0 to 10, with 0 for no pain to 10 for the worst possible pain. On the case report form each day had 6 time categories: waking up in the morning, around lunch time, afternoon approximately 3-4 pm, dinner time, bedtime, and during the night time. Each day was averaged for each subject, then the values for each arm were averaged.|Days 1-7 post operation|The numbers of participants analyzed varied each day. The numbers per arm analyzed per day category are expressed in the table as (n=Thoracic epidural, ON-Q).||units on a scale||Standard Deviation|Mean
662690|NCT01816477|Primary|Use of Analgesic Narcotic|Postoperative analgesic used each day over 7 day postoperative period.|1-7 days post operation|The numbers of participants analyzed varied each day. The numbers per arm analyzed per day category are expressed in the table as (n=Thoracic epidural, ON-Q). The protocol had planned to use the area under the curve, but this was not analyzed in the published paper, due to the presence of missing data in the analgesic narcotic measurements.||morphine milligram equivalents||Standard Deviation|Mean
662691|NCT01816477|Primary|Hospital Length of Stay|Hospital length of stay was measured from the day of surgery (day 0) through postoperative day 11.|Up to 11 days post operation|||days||Standard Deviation|Mean
662692|NCT01816451|Primary|Fat Mass (%)|The subjects underwent a set of anthropometric assessments, which followed the norms of the International Society for Advancement of Kinanthropometry. The fat mass was calculated by percentage using the equation proposed by Jackson and Pollock (1978) from seven skinfold measurement. To measure the skinfolds, a Sanny Professional Skinfold Caliper was used.|Pre and post 14 weeks/46 sessions of training|||Fat Mass %||Standard Deviation|Mean
662693|NCT01816451|Primary|Rate of Perceived Exertion (RPE) on Maximal Test|"The RPE was collected at maximal test (see description of test on outcome measure Maximal Oxygen Uptake). Relative to overall feelings were collected by Category Ratio Scale (CR10) during the last 15 s of each stage using the Borg category (0 – 10) scale. Instructions for RPE were that “0” corresponds to rest, and “9 - 10” corresponds to maximal exertion. This verbal procedure was explained before initiating exercise."|Pre and post 14 weeks/46 sessions of training|||units on a scale||Standard Deviation|Mean
662694|NCT01816451|Primary|Body Mass (BM)|To measure body mass Filizola scales with a stadiometer was used.|Body Mass was collected pre and post training|||kg||Standard Deviation|Mean
662695|NCT01816451|Primary|Blood Lactate Concentrations on Maximal Test|Capillary blood samples (25 µl) were obtained from the finger of each subject during all tests and the [La] were measured using an (Accutrend®Plus Roche Diagnostics Gesellschaft mit beschränkter Haftung , Mannheim, Germany). The measuring range was 0.8–22 millimole (mM). The sample is collecting (Accu-Chek® Softclix) and first applied to a coded yellow test strip (Accutrend Blood measure-Roche) with a reagent chemical substance. Blood was added to the strip by letting it drip from a finger; in accordance with the instrument’s instructions. The finger never touched the strip’s pad in order to exclude any possible interference due to the sweat. All [La] were collected by a single, experienced investigator.|Pre and post 14 weeks/46sessions on rest (5 min sitting position; before start the test); 1-3-5 min immediately after the end of the test (on sitting position).|||mmol*L^-1||Standard Deviation|Mean
662696|NCT01816451|Secondary|Rate of Perceived Exertion (RPE) on Submaximal Test|"The RPE was collected at submaximal test (see description of test on outcome measure HR at submaximal test). Relative to overall feelings were collected by Category Ratio Scale (CR10) during the last 15 s of each stage using the Borg category (0 – 10) scale. Instructions for RPE were that “0” corresponds to rest, and “9 - 10” corresponds to maximal exertion. This verbal procedure was explained before initiating exercise."|Pre; during (retest I 0-6weeks; retest II 0-10 weeks) and post 14 weeks/46sessions training|The control group didn't do the submaximal test because it was done only for determine and adjusted the training intensities.||units on a scale||Standard Deviation|Mean
662697|NCT01816451|Secondary|Submaximal Velocity [Vsub]|Submaximal tests were done at the same treadmill (Treadmill® TR9100HR, Life Fitness, USA) as training.Before the test, all subjects should be able to do it at moderate-high intensity. The test began with three minutes of progressive warm-up. During the first minute, the subject maintains a light level; during the second and third minutes of the warm-up, the intensity was moderate. Starting from the fourth minute, the subject should be able to maintain a velocity for the next seven to ten minutes. This load can be adjusted as required, through verbal communication between the subject and the evaluator. The test finishes at the end of 10 minutes. The test velocity should be clearly constant at the end of the test. Values of velocity were monitored and recorded at the end of each minute, e.g. 10 seconds before ending each measured minute, and the last measurement were at the end of the 10 minutes. The objective of this procedure was to identify the value of that speed has stabilized.|Pre; during (retest I 0-6weeks; retest II 0-10 weeks) and post 14 weeks/46sessions of training|The control group didn't do the submaximal test because it was done to determine and adjusted the HR training intensities and also collected [Vsub] during submaximal effort.||km/h||Standard Deviation|Mean
662698|NCT01816451|Secondary|Blood Lactate on Submaximal Test|Capillary blood samples (25 µl) were obtained from the finger of each subject during all tests and the [La] were measured using an (Accutrend®Plus Roche Diagnostics Gesellschaft mit beschränkter Haftung , Mannheim, Germany). The measuring range was 0.8–22 mM. The sample is collecting (Accu-Chek® Softclix) and first applied to a coded yellow test strip (Accutrend Blood Measure-Roche) with a reagent chemical substance. Blood was added to the strip by letting it drip from a finger; in accordance with the instrument’s instructions we never let the finger touch the strip’s pad in order to exclude any possible interference due to the sweat.|Pre; during (retest I 0-6weeks; retest II 0-10 weeks) and post 14 weeks/46 sessions training: rest (5-min sitting; before start the test); 1-3-5 minutes immediately after the end of the test (on sitting position).|The control group didn't do the submaximal test because it was done to determine and adjusted the HR training intensities and also collected [La] on rest and after submaximal effort during 14 weeks of training.||mmol*L^-1||Standard Deviation|Mean
662726|NCT01815918|Primary|Plasmin-alpha-2-antiplasmin Complex (PAP), a Marker of Fibrinolysis|Study patients received 100 mg of intravenous hydrocortisone 2 h prior to surgery, and controls received normal saline. Blood samples, drawn pre-incision and at 4 h post tourniquet release, were assayed for PF1.2 and PAP|Baseline and up to 4 hours following surgery|||ug/L||Standard Deviation|Mean
663220|NCT01808209|Secondary|Conjunctival Redness|Assessment of ocular health. Collected at baseline after removal of lenses. Percentage of conjunctival redness.|Baseline|||percentage of redness|Participants|Standard Deviation|Mean
662699|NCT01816451|Secondary|Heart Rate on Submaximal Test|Submaximal tests were done at the same treadmill (Treadmill® TR9100HR, Life Fitness, USA) as training.Before the test, all subjects should be able to do it at moderate-high intensity. The test began with three minutes of progressive warm-up. During the first minute, the subject maintains a light level; during the second and third minutes of the warm-up, the intensity was moderate. Starting from the fourth minute, the subject should be able to maintain a velocity for the next seven to ten minutes. This load can be adjusted as required, through verbal communication between the subject and the evaluator. The test finishes at the end of 10 minutes.The test velocity should be clearly constant at the end of the test. Heart rate were monitored and recorded at the end of each minute, e.g. 10 seconds before ending each measured minute, and the last measurement were at the end of the 10 minutes. The objective of this procedure was to identify the HR values for training intensities.|Pre; during (retest I 0-6weeks; retest II 0-10 weeks) and post 14 weeks/46sessions training: rest (5-min sitting; before start the test); maximal during the test (maxHRsub); 60s-120s immediately after the end of the test (on sitting position).|The control group didn't do the submaximal test because it was done to determine and adjusted the training intensities during the 14 weeks.||bpm||Standard Deviation|Mean
662700|NCT01816451|Primary|Heart Rate on Maximal Test|The HR was collected pre and post training on maximal VO2 test. Initially, with the individual on the treadmill (Inbrasport Master Super, Porto Alegre, Brazil), electrodes (Micromed) were placed at the manubrium, right and left iliac crest for measured heart rate (HR) (derivation CM5) and were connected to an electromyography equipment (Micromed®). HR values were visualized through Elite software (Micromed Biotechnology, Brasilia, Brazil).|Pre and post 14 weeks at rest (5 min sitting; before start the test), during the test (to determine max), and 60s and 120s immediately after the end of the test (on sitting position)|||bpm||Standard Deviation|Mean
662701|NCT01816451|Primary|Total Time Reaching on Maximal Test (tVO2max)|The criterion for determining the total time reaching in maximal VO2 test was associated with the time immediately preceding heart rate shown a reduction of five or more beats.|Pre and post 14 weeks/46 sessions of training|||minutes||Standard Deviation|Mean
662702|NCT01816451|Primary|Absolute Maximal Oxygen Uptake|The absolute maximal oxygen uptake was taken by individual connected to a metabolic gas analyzer (VO-2000, Aerosport, Medgraphics, St. Paul, Minnesota) through which the gas samples were collected and measured each 10 seconds during the test. The participants were submitted to a ramp protocol with an initial velocity of 8.0 km/h (0% of inclination), progressive increments, a final velocity of 18 km/h (2% de inclination). The duration was equal to 10 minutes or until voluntary exhaustion.|Pre and post 14 weeks|||L/min||Standard Deviation|Mean
662703|NCT01816451|Primary|Relative Maximal Oxygen Uptake|The relative maximal oxygen uptake was taken by individual connected to a metabolic gas analyzer (VO-2000, Aerosport, Medgraphics, St. Paul, Minnesota) through which the gas samples were collected and measured each 10 seconds during the test. The participants were submitted to a ramp protocol with an initial velocity of 8.0 km/h (0% of inclination), progressive increments, a final velocity of 18 km/h (2% de inclination). The duration was equal to 10 minutes or until voluntary exhaustion.|Pre and post 14 weeks|||mL/(kg*min)||Standard Deviation|Mean
662704|NCT01816295|Secondary|Number of Participants With Prostate Specific Antigen (PSA) >4 Nanogram/Milliliter (ng/mL)||Double Blind Baseline, Week 12, Open Label Baseline, Week 36|All participants with non-missing PSA result at the specified time point.||participants|||Number
662705|NCT01816295|Other Pre-specified|Change From Baseline in Total International Prostate Symptom Score (IPSS)|The IPSS is a self-administered instrument used to assess for the severity of lower urinary tract symptoms. The IPSS consists of 7 questions that were scored on a scale from 0 (none/no symptoms) to 5 (frequent symptoms), for a total score range of 0 to 35. Higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. LS mean change from baseline was calculated using ANCOVA with treatment group and the baseline value as covariates.|Baseline, Week 12, Week 36|All randomized participants with non-missing baseline IPSS measurement and at least one non-missing post baseline IPSS measurement. Missing data endpoints were imputed using LOCF.||units on a scale||Standard Error|Least Squares Mean
662706|NCT01816295|Secondary|Change From Baseline to Week 12 in Hypogonadism Energy Diary (HED) Scores|"The HED is a self-administered instrument used to assess real-time energy levels in men with symptomatic hypogonadism. It consists of 2 questions that were scored on a scale from 0 to 10, with “10” corresponding to Full of Energy or Not Tired at All (The Tiredness scale was reverse-mapped, as it was collected with “10” corresponding to Extreme Tiredness). The questionnaire was completed 3 times daily (forming 6 unique items) for 7 consecutive days. Item scores were computed by averaging the values for each item across 7 days. If more than 2 days were missing for an item, the item score was missing. The total score was computed by summing the item scores and linearly transforming the sum to a 0 to 100 scale, with higher scores corresponding to greater energy. If any item score was missing, the total score was missing. LS mean change from baseline was calculated using ANCOVA with treatment group and the baseline value as covariates."|Baseline, Week 12|Randomized participants who reported low energy at baseline with non-missing HED questionnaire at baseline and at least one post baseline visit. Missing data endpoints were imputed using LOCF.||units on a scale||Standard Error|Least Squares Mean
662707|NCT01816295|Secondary|Change From Baseline to Week 12 in Sexual Arousal, Interest, and Drive (SAID) Scale Scores|"The SAID Scale is a self-administered instrument used to assess sexual arousal, interest, and sex drive in men with symptomatic hypogonadism. The SAID consists of 5 questions that were scored on a scale from 1 to 5, with 5 corresponding to greater levels of sexual arousal, interest, or drive. The SAID Scale total score was computed by summing the item scores and linearly transforming the sum to a 0 to 100 scale, with higher scores corresponding to greater sexual arousal, interest, and drive. Least squares (LS) mean change from baseline was calculated using an analysis of covariance (ANCOVA) with treatment group and the baseline value as covariates."|Baseline, Week 12|Randomized participants who reported low sex drive at baseline with non-missing SAID Scale data at baseline and at least one post baseline visit. Missing data endpoints were imputed using last observation carried forward (LOCF).||units on a scale||Standard Error|Least Squares Mean
662708|NCT01816295|Primary|Number of Participants With Total Serum Testosterone Concentration Within Normal Range at Week 12|Normal range for total serum testosterone was defined as 300 to 1050 nanograms per deciliter (ng/dL).|Week 12|All randomized participants who completed 12 weeks of treatment and had non-missing testosterone concentration at week 12.||participants|||Number
662709|NCT01816243|Secondary|Number of Participants With Participant's Global Assessment|Participants global assessment with respect to pain control using a 9-point scale (-4 to 4; where, -4=100% worse, 0=unchanged and 4=100% improvement), safety using 5-point scale (1 to 5; where, 1=no, 2=mild, 3=moderate, 4=severe and 5=most severe side effects) and 5-point overall satisfaction scale (1-5; where, 1=no, 2=mild, 3=moderate, 4=good, 5=excellent). Number of participants with participant's global assessment with respect to efficacy, safety and overall satisfaction were reported.|Day 30|The ITT population set included all participants who received at least one dose of study drug and had at least one post-baseline efficacy assessment. 'N' (number of participants analyzed) = participants who were evaluable for this measure and 'n' = participants who were evaluable for this measure at given time points.||Participants|||Number
662710|NCT01816243|Secondary|Number of Participants With Investigator's Global Assessment|Investigator would complete a global assessment of the participants treatment with respect to pain control using a 9-point scale (-4 to 4; where, -4=100 percent (%) worse, 0=unchanged and 4=100% improvement), safety using 5-point scale (1 to 5; where, 1=no, 2=mild, 3=moderate, 4=severe and 5=most severe side effects) and 5-point overall satisfaction scale (1-5; where, 1=no, 2=mild, 3=moderate, 4=good, 5=excellent). Number of participants with Investigator's assessment with respect to efficacy, safety and overall satisfaction were reported.|Day 30|The ITT population set included all participants who received at least one dose of study medication and who had at least one post-baseline efficacy assessment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||Participants|||Number
662711|NCT01816243|Primary|Change From Baseline in Pain Intensity Rating at Day 30|Pain intensity was assessed on 11-point NRS; score ranges from 0 to 10 where 0=no pain and 10=worst pain.|Baseline and Day 30|The ITT population set included all participants who received at least one dose of study medication and who had at least one post-baseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
662712|NCT01816243|Primary|Change From Baseline in Pain Intensity Rating at Day 15|Pain intensity was assessed on 11-point Numeric Rating Scale (NRS); score ranges from 0 to 10 where 0=no pain and 10=worst pain.|Baseline and Day 15|Intent-to-treat (ITT) population set included all participants who received at least one dose of study medication and who had at least one post-baseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
663983|NCT01792830|Secondary|Severe Hypoglycemic Events|Number of subjects that experienced severe hypoglycemia, defined as blood glucose levels ≤ 40 mg/dl|3 months after discharge||||||
662728|NCT01815840|Secondary|Percent Change From Baseline in the Skindex-16 Function Domain Score at Week 73|"The Skindex-16 is a patient-reported outcome health questionnaire. Participants were asked about their ability to function, and answers were combined into a composite Function Domain Score. Scores range from 0 (never bothered) to 100 (“always bothered”)."|Baseline; Week 73|Participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) with available data were included in the analysis.||percent change||Standard Deviation|Mean
662729|NCT01815840|Secondary|Percent Change From Baseline in the Skindex-16 Emotion Domain Score at Week 73|"The Skindex-16 is a patient-reported outcome health questionnaire. Participants were asked about their emotional state, and their answers were combined into a composite Emotion Domain Score. Scores range from 0 (never bothered) to 100 (“always bothered”)."|Baseline; Week 73|Participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) with available data were included in the analysis.||percent change||Standard Deviation|Mean
662730|NCT01815840|Secondary|Percent Change From Baseline in the Skindex-16 Symptom Domain Score at Week 73|"The Skindex-16 is a patient-reported outcome health questionnaire. Participants were asked about their symptoms, and their answers were combined into a composite Symptom Domain Score. Scores range from 0 (never bothered) to 100 (“always bothered”)."|Baseline; Week 73|Participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) with available data were included in the analysis.||percent change||Standard Deviation|Mean
662731|NCT01815840|Secondary|Percentage of Participants Experiencing Any Adverse Event||Up to 125 weeks|Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.||percentage of participants|||Number
662732|NCT01815840|Secondary|Percent Change in Total Number of Basal Cell Carcinomas Relative to Baseline at Week 125 (52 Weeks Following End of Treatment) (Recurrence Rate)||Baseline; Week 125|Participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) with available data were included in the analysis.||percent change||Standard Deviation|Mean
662733|NCT01815840|Secondary|Percent Change in Total Number of Basal Cell Carcinomas Relative to Baseline at Week 97 (24 Weeks Following End of Treatment) (Recurrence Rate)||Baseline; Week 97|Participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) with available data were included in the analysis.||percent change||Standard Deviation|Mean
662734|NCT01815840|Secondary|Percent Change in Total Number of Basal Cell Carcinomas Relative to Baseline at Week 85 (12 Weeks Following End of Treatment) (Recurrence Rate)||Baseline; Week 85|Participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) with available data were included in the analysis.||percent change||Standard Deviation|Mean
662735|NCT01815840|Secondary|Percentage of Participants With New Basal Cell Carcinomas at Week 73||Baseline; Week 73|Participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) with available data were included in the analysis.||percentage of participants|||Number
662736|NCT01815840|Secondary|Percentage of Participants With at Least 50% Reduction in the Number of Basal Cell Carcinomas at Week 73||Baseline; Week 73|Intent-to-Treat Analysis Population, defined as all randomized participants.||percentage of participants|||Number
662737|NCT01815840|Secondary|Mean Percent Change From Baseline in Total Size of Three Target Basal Cell Carcinoma Lesions in Individual Participants at Week 73|The three target basal cell carcinoma lesions = the three largest visible lesions, at least 5 mm in the longest diameter, in individual participants.|Baseline; Week 73|Participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) with available data were included in the analysis.||percent change||Standard Deviation|Mean
662738|NCT01815840|Secondary|Percentage of Participants Who Discontinued Study Treatment Due to Tolerability Issues|The percentage of participants who discontinued study treatment (due either to adverse event, refusal of treatment, or withdrawal of consent) was summarized by treatment group.|Baseline to Week 73|Intent-to-Treat Analysis Population, defined as all randomized participants.||percentage of participants||95% Confidence Interval|Number
662739|NCT01815840|Primary|Mean Percent Change From Baseline in the Number of Clinically Evident Basal Cell Carcinomas at Week 73 (After 72 Weeks of Treatment)|The total number of clinically evident basal cell carcinomas = the total number of target and/or non-target lesions present in individual participants.|Baseline; Week 73|Participants in the Intent-to-Treat analysis population (defined as all randomized participants) with available data were included in the analysis. The last observation carried forward method was used.||percent change||Standard Deviation|Mean
662740|NCT01815736|Secondary|Change From Baseline in Overall EFV-related Symptom Assessment Score at Week 48|"The mean (SD) change of the overall EFV-related symptom assessment score is presented. The overall symptom score (ranging from 0 to 20) is the sum of the individual symptom scores ranging from 0 (no symptoms) to 4 (most severe symptoms) from the 5 EFV-related symptom assessments (dizziness, trouble sleeping, impaired concentration, sleepiness, and abnormal or vivid dream).
EFV-Related Symptom Analysis Set: participants who received EFV/FTC/TDF as prior treatment, received at least 1 dose of study drug, and completed EFV-related symptom assessments at the baseline visit and at least 1 postbaseline visit."|Baseline; Week 48|"Participants in EFV-Related Symptom Analysis Set with available data were analyzed.
NDA Data Cut = participants through data cut for E/C/F/TAF NDA; All Participants = participants through Week 48 Data Cut"||units on a scale||Standard Deviation|Mean
662741|NCT01815736|Secondary|Change From Baseline in Serum Creatinine at Week 48||Baseline; Week 48|"Participants in the Safety Analysis Set (randomized participants who received ≥ 1 dose of study drug) excluding participants with prior treatment of EFV/FTC/TDF.
NDA Data Cut = participants through the data cut for the E/C/F/TAF NDA; All Participants = participants through the Week 48 Data Cut"||mg/dL||Standard Deviation|Mean
662742|NCT01815736|Secondary|Percent Change From Baseline in Spine BMD at Week 48|Spine BMD was assessed by DXA scan. BMD is calculated as g/cm^2; the mean (SD) percentage change is presented.|Baseline; Week 48|"Participants in the Spine DXA Analysis Set (participants who received ≥ 1 dose of study drug and had nonmissing baseline spine BMD) with available data were analyzed.
NDA Data Cut = participants through the data cut for the E/C/F/TAF NDA; All Participants = participants through the Week 48 Data Cut."||percentage change||Standard Deviation|Mean
663221|NCT01808209|Secondary|Blood Vessel Coverage|Assessment of ocular health. Collected at 1 week after removal of lenses. Percentage of blood vessel coverage.|1 Week|All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.||percentage of blood vessel coverage|Participants|Standard Deviation|Mean
662743|NCT01815736|Secondary|Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48|Hip BMD was assessed by dual energy x-ray absorptiometry (DXA) scan. BMD is calculated as grams per square centimeter (g/cm^2); the mean (SD) percentage change is presented.|Baseline; Week 48|"Participants in the Hip DXA Analysis Set (participants who received ≥ 1 dose of study drug and had nonmissing baseline hip BMD) with available data were analyzed.
NDA Data Cut = participants through the data cut for the E/C/F/TAF NDA; All Participants = participants through the Week 48 Data Cut."||percentage change||Standard Deviation|Mean
662744|NCT01815736|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|"Full Analysis Set: participants who were randomized and received at least 1 dose of study drug.
New Drug Application (NDA Data Cut) = participants through the data cut for the E/C/F/TAF NDA; All Participants = participants through the Week 48 Data Cut."||percentage of participants|||Number
662745|NCT01815671|Secondary|Pain Related or Possibly Related to Colonoscopy Procedure|Visual Analogue Scale measured 0-4 with zero being no pain and 4 being most severe pain.|24 hours|||units on a scale||Standard Deviation|Mean
662746|NCT01815671|Secondary|Time to Full Colonoscope Insertion||30 minutes|||minutes||Standard Deviation|Mean
662747|NCT01815671|Primary|Number of Participants Who Experience Adverse Events Which Are Related or Possibly Related to the Colonoscopy Procedure|The number of participants who experience adverse events which are related or possibly related to the colonoscopy procedure will be tallied in each treatment arm.|24 hours|||participants|||Number
662748|NCT01815645|Secondary|Percentage Samples Submitted Negative for Marihuana Use|The proportion of samples testing negative for marijuana was determined by dividing the number of negative samples by the total number of expected samples (36 samples)|12 weeks|||percent of sample|percent of sample||Number
662749|NCT01815645|Secondary|Percentage Samples Submitted Negative for Alcohol Use|Proportion of samples testing negative for alcohol use|12 weeks|||percent of sample|||Number
662750|NCT01815645|Primary|Treatment Attendance|Treatment attendance was expressed as the total number of sessions attended during the 12 weeks of treatment.|12 weeks|we compared group means for the total number of attended sessions.||attended treatment sessions||Standard Deviation|Mean
662751|NCT01815645|Primary|Number of Participants Completing 4, 8 and 12 Weeks of Treatment|Retention in treatment was quantified as the period elapsed between treatment intake and dropout (last appearance at the treatment facility) or the end of treatment. We present data on the number of participants retained in treatment in weeks 4, 8 and 12.|Number of participant retained in treatment at weeks 4, 8 and 12.|||number of participants|||Number
662752|NCT01815645|Primary|Percentage Samples Submitted Negative for Crack Cocaine Use|Proportion of samples testing negative for Crack Cocaine use|12 weeks|||percentage of submitted negative samples|urine samples||Number
662753|NCT01815645|Primary|Longest Duaration of Achieved Abstinance|Number of Participants with 4, 8 and 12 Weeks Continued Abstinence|12 weeks of treatment|Longest duaration of abstinance was determined by the highest amount of consecutive negative crack/cocaine samples submitted.||number of participants|||Number
662754|NCT01815138|Other Pre-specified|Abdominal Distension|Patients will complete a questionnaire to determine if there is a difference in the effect of the intervention on the quality of life (abdominal distension) of the patients from the day of trigger of oocyte maturation until menses or positive pregnancy test.|Within 2 weeks after trigger of oocyte maturation|Some patients did not complete the questionnaire. Abdominal distension analyzed||Participants|||Count of Participants
662755|NCT01815138|Other Pre-specified|Markers of Corpus Luteum Function|A subset of patients (20 patients in each group) will have serum frozen for subsequent analysis of 17 hydroxy progesterone and prorenin.|Within 60 days after trigger of oocyte maturation|Subset of women included in larger study, normal or high responders, peak estradiol level less than 4000 pg/mL on day of trigger.||ng/mL||Standard Deviation|Mean
662756|NCT01815138|Secondary|Ovarian Hyperstimulation Syndrome|Evaluation of symptoms and signs of OHSS at 9 days after trigger of oocyte maturation. Patients who also present with symptoms of OHSS wil also be evaluated for OHSS within 4 weeks after oocyte maturation.|Within 4 weeks of oocyte retrieval|Women with normal or high response to IVF, peak estradiol on day of trigger less than 4000 pg/mL.||Participants|||Count of Participants
662757|NCT01815138|Primary|Ongoing Pregnancy|Positive serum pregnancy test and ultrasound evidence of fetal pole and fetal heart rate .|Through time of study completion, on average 1-2years|per protocol analysis||participants|||Number
662758|NCT01815099|Primary|Change in The Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) Before and After TMS Treatment.|The Hamilton Anxiety Rating Scale (HARS) is one of the most commonly used and extensively validated outcome measures for anxiety symptoms. The SIGH-A allows for a standardized administration of the HARS. The total score was used in this study. The total score ranges from 0 to 56 with higher scores indicative of more severe anxiety symptoms.|Approximately 1 week prior to initial TMS treatment session, 1 week after final TMS treatment session|rTMS treatment completers||units on a scale||Standard Deviation|Mean
662759|NCT01815008|Secondary|Changes in Platelet Transcriptome With Clopidogrel|Platelet transcriptome will be examined before and after 1 week of therapy with clopidogrel and differences will be determined|At baseline and at 1 week|Note: The 2nd week of the study was not performed as we could not find low risk population in our cohort who could be given both anti-platelets without increased estimated risk of bleeding. Note that the top most gene (CNOT2) with the lowest p-value is being reported.||FPKM||Standard Error|Mean
662760|NCT01815008|Secondary|Difference in Collagen-induced Platelet Aggregation|Collagen-induced platelet aggregation will be measured using impedance aggregometry in whole blood before and after 1-week of clopidogrel. The difference between the baseline and after clopidogrel therapy will be determined|At Baseline and at 1 week|Note: The 2nd week of the study was not performed as we could not find low risk population in our cohort who could be given both anti-platelets without increased estimated risk of bleeding.||Difference in ohms (Post-Pre)||Standard Deviation|Mean
663222|NCT01808209|Primary|Visual Acuity logMAR|Assessment of Binocular High Contrast Distance Visual Acuity (BHCVA). Collected at 1 week for study lenses. logMAR|1 Week|All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.||logMAR||Standard Deviation|Mean
662761|NCT01815008|Secondary|Difference in Arachidonic Acid-induced Platelet Aggregation|Arachidonic Acid-induced platelet aggregation will be measured using impedance aggregometry in whole blood before and after 1-week of clopidogrel. The difference between the baseline and after clopidogrel therapy will be determined|At baseline and after 1-week|Data was collected before and after one week of clopidogrel. We found it difficult to enroll patients with low risk to the combined aspirin and clopidogrel and hence study was continued for the first week only.||Difference in ohms (Post-Pre)||Standard Deviation|Mean
662762|NCT01815008|Primary|Difference in ADP-induced Platelet Aggregation|ADP-induced platelet aggregation will be measured using impedance aggregometry in whole blood before and after 1-week of clopidogrel. The difference between the baseline and after clopidogrel therapy will be determined. Higher impedance represent higher platelet aggregation.|at baseline and at 1 week|Data was collected before and after one week of clopidogrel. We found it difficult to enroll patients with low risk to the combined aspirin and clopidogrel and hence study was continued for the first week only.||Difference in ohms (Post-Pre)||Standard Deviation|Mean
662763|NCT01814878|Secondary|Patient Global Impression of Change (PGIC) Score|The PGIC was used to assess the degree of participant’s overall improvement with treatment, and participants were instructed to assess how much the overall status had been improved after investigational product administration compared to baseline in 7 grades (1=Very much improved and B=Very much worsened).|Day 3|The intent-to-treat population included all randomly assigned participants. Here, 'N' specifies those participants who were evaluable for this outcome measure.||Units on scale||Standard Deviation|Mean
662764|NCT01814878|Secondary|Dosage of Rescue Medication Administered Because of Insufficient Pain Relief|The dosage of the rescue medication (rescue medications are medicines that are administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation) because of insufficient pain relief was measured after administration of the study drug. Rescue medications allowed were oral or injection of tramadol HCl (intramuscular or intravenous injection).|Baseline up to Day 3|The intent-to-treat population included all randomly assigned participants. Here, 'N' specifies those participants who were evaluable for this outcome measure.||Milligram||Standard Deviation|Mean
662765|NCT01814878|Secondary|Number of Doses of Rescue Medication Administered Because of Insufficient Pain Relief|The frequency of the rescue medication (rescue medications are medicines that are administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation) because of insufficient pain relief was measured after administration of the study drug. Rescue medications allowed were oral or injection of tramadol HCl (intramuscular or intravenous injection).|Baseline up to Day 3|The intent-to-treat population included all randomly assigned participants. Here, 'N' specifies those participants who were evaluable for this outcome measure.||Doses||Standard Deviation|Mean
662766|NCT01814878|Secondary|Time to the First Rescue Medication Administered Because of Insufficient Pain Relief|The time until administration of the first rescue medication (rescue medications are medicines that are administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation) because of insufficient pain relief after administration of the study drug was recorded. Rescue medications allowed were oral or injection of tramadol HCl (intramuscular [directly into muscle] or intravenous injection [directly into vein]).|Baseline up to Day 3|The intent-to-treat population included all randomly assigned participants. Here, 'N' specifies those participants who were evaluable for this outcome measure.||Minutes||Standard Deviation|Mean
662767|NCT01814878|Secondary|Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID)|The SPRID is sum of SPID and TOTPAR. In SPID, PI score ranges from 0-3 where 0=no pain and 3=severe pain. PI score of 0=NRS score of 0, PI score of 1=NRS score >=1 and <= 3, PI score of 2=NRS score of >=4 and <=6 and PI score of 3=NRS score of >=7 and <=10. In TOTPAR, pain relief score ranges from 0-4 (0=no change, 1=slight relief, 2=moderate relief, 3=fair relief, 4=pain resolved completely). Total score ranges from -18 (worst) to 42 (best) for SPRID6, -36 (worst) to 84 (best) for SPRID12, -72 (worst) to 168 (best) for SPRID24 and -144 (worst) to 336 (best) for SPRID48.|Hour 6, 12, 24, 48|The intent-to-treat population included all randomly assigned participants. Here, 'N' specifies those participants who were evaluable for this outcome measure.||Units on scale||Standard Deviation|Mean
662768|NCT01814878|Secondary|Total Pain Relief (TOTPAR) Score|Pain relief was measured on a 5-point categorical scale of 0-4 (0=no change, 1=slight relief, 2=moderate relief, 3=fair relief, 4=pain resolved completely). TOTPAR was calculated as the time-weighted sum over all pain relief up to 48 hours. Total score ranges from 0 (worst) to 24 (best) for TOTPAR6, 0 (worst) to 48 (best) for TOTPAR12, 0 (worst) to 96 (best) for TOTPAR24 and 0 (worst) to 192 (best) for TOTPAR48.|Hour 6, 12, 24, 48|The intent-to-treat population included all randomly assigned participants. Here, 'N' specifies those participants who were evaluable for this outcome measure.||Units on scale||Standard Deviation|Mean
662769|NCT01814878|Secondary|Sum of Pain Intensity Difference (SPID) at Hour 6, 12 and 24|The SPID is time-weighted sum of all observations of PID collected at each measurement time point from Baseline to 24 hours. PID: Baseline PI minus current PI; PI was assessed using 11-point NRS, 0=no pain to 10=worst pain imaginable. PI score ranges from 0-3 where 0=no pain and 3=severe pain. PI score of 0=NRS score of 0, PI score of 1=NRS score >=1 and <=3, PI score of 2=NRS score of >=4 and <=6 and PI score of 3=NRS score of >=7 and <=10. Total score ranges from -18 (worst) to 18 (best) for SPID6, -36 (worst) to 36 (best) for SPID12 and -72 (worst) to 72 (best) for SPID24.|Hour 6, 12, 24|The intent-to-treat population included all randomly assigned participants. Here, 'N' (number of participants analyzed) specifies those participants who were evaluable for this outcome measure.||Units on scale||Standard Deviation|Mean
662790|NCT01814800|Secondary|Correlation Between Trough Level of RI-002 and Serious and Non-serious Infections|The relationship between trough IgG concentrations and the number of infections of any kind/seriousness was evaluated using Pearson linear correlation coefficients using forward analysis (outcomes after infusion) and backward analysis (outcomes prior to infusion; outcomes post last infusion were excluded)|Up to 1 year|||Linear Correlation Coefficients|||Number
663223|NCT01808209|Primary|Visual Acuity logMAR|Assessment of Monocular (MHCVA) Right eye (OD), left eye (OS) and Binocular High Contrast Distance Visual Acuity (BHCVA). Collected at dispense for study lenses. logMAR.|Dispense|All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.||logMAR||Standard Deviation|Mean
662770|NCT01814878|Primary|Sum of Pain Intensity Difference (SPID) at Hour 48|The SPID is time-weighted sum of all observations of pain intensity difference (PID) collected at each measurement time point from Baseline to 48 hours. PID: Baseline pain intensity (PI) minus current PI; PI was assessed using 11-point numeric rating scale (NRS, 0=no pain to 10=worst pain imaginable). PI score ranges from 0-3 where 0=no pain and 3=severe pain. PI score of 0=NRS score of 0, PI score of 1=NRS score >=1 and <=3, PI score of 2=NRS score of >=4 and <=6 and PI score of 3=NRS score of >=7 and <=10. Total score for SPID at 48 hours (SPID48) ranges from -144 (worst) to 144 (best).|Hour 48|The per-protocol (PP) population included all randomly assigned participants who did not violate major eligibility criteria and whose SPID was calculated with actual measurements or adjusted values at all assessment time points.||Units on scale||Standard Deviation|Mean
662771|NCT01814800|Post-Hoc|Number of Participants With No Days Lost From Work/School/Daycare Due to Infections and Their Treatment|Additional analysis performed to separate the number of days lost from work, school and/or daycare from the days missed from normal activities, due to infection. Presenting the number of subjects with no (0) days lost from work/school/daycare due to infection|Up to 1 year|Analysis includes 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002||participants|||Number
662772|NCT01814800|Post-Hoc|Number of Days Lost From Work/School/Daycare Due to Infections and Their Treatment - Per Subject-Year|Additional analysis performed to separate the number of days lost from work, school and/or daycare from the days missed from normal activities, due to infection|Up to 1 year|Analysis includes 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002||Days per subject-year|||Number
662773|NCT01814800|Post-Hoc|Number of Days Lost From Work/School/Daycare Due to Infections and Their Treatment|Additional analysis performed to separate the number of days lost from work, school and/or daycare from the days missed from normal activities, due to infection|Up to 1 year|Analysis includes 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002||Days|||Number
662774|NCT01814800|Secondary|Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 23F|Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 23F|Up to 1 year|Number available for analysis varied by infusion; 53-59 subjects||ug/mL||Standard Error|Mean
662775|NCT01814800|Secondary|Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 19F|Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 19F|Up to 1 year|Number available for analysis varied by infusion; 53-59 subjects||ug/mL||Standard Error|Mean
662776|NCT01814800|Secondary|Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 19A|Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 19A|Up to 1 year|Number available for analysis varied by infusion; 51-54 subjects||ug/mL||Standard Error|Mean
662777|NCT01814800|Secondary|Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 18C|Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 18C|Up to 1 year|Number available for analysis varied by infusion; 53-59 subjects||ug/mL||Standard Error|Mean
662778|NCT01814800|Secondary|Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 14|Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 14|Up to 1 year|Number available for analysis varied by infusion; 53-59 subjects||ug/mL||Standard Error|Mean
662779|NCT01814800|Secondary|Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 9V|Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 9V|Up to 1 year|Number available for analysis varied by infusion; 53-59 subjects||ug/mL||Standard Error|Mean
662780|NCT01814800|Secondary|Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 7F|Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 7F|Up to 1 year|Number available for analysis varied by infusion; 53-57 subjects||ug/mL||Standard Error|Mean
662781|NCT01814800|Secondary|Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 6B|Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 6B|Up to 1 year|Number available for analysis varied by infusion; 53-59 subjects||ug/mL||Standard Error|Mean
662782|NCT01814800|Secondary|Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 5|Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 5|Up to 1 year|Number available for analysis varied by infusion; 52-58 subjects||ug/mL||Standard Error|Mean
662783|NCT01814800|Secondary|Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 4|Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 4|Up to 1 year|Number available for analysis varied by infusion; 53-58 subjects||ug/mL||Standard Error|Mean
662784|NCT01814800|Secondary|Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 3|Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 3|Up to 1 year|Number available for analysis varied by infusion; 53-59 subjects||ug/mL||Standard Error|Mean
662785|NCT01814800|Secondary|Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 1|Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 1|Up to 1 year|Number available for analysis varied by infusion; 53-59 subjects||ug/mL||Standard Error|Mean
662786|NCT01814800|Secondary|Trough Total IgG and Specific Antibody Levels - Tetanus|Summary of trough antibody concentrations prior to specified infusion for Tetanus|Up to 1 year|Number available for analysis varied by infusion; 53-59 subjects||IU/mL||Standard Error|Mean
662787|NCT01814800|Secondary|Trough Total IgG and Specific Antibody Levels - Respiratory Syncytial Virus (RSV)|Summary of trough antibody concentrations prior to specified infusion for Respiratory Syncytial Virus (RSV)|Up to 1 year|Number available for analysis varied by infusion; 51-56 subjects||titer||Standard Error|Mean
662788|NCT01814800|Secondary|Trough Total IgG and Specific Antibody Levels - Haemophilus Influenzae Type B|Summary of trough antibody concentrations prior to specified infusion for Haemophilus influenzae type B|Up to 1 year|Number available for analysis varied by infusion; 53-59 subjects||ug/mL||Standard Error|Mean
662789|NCT01814800|Secondary|Trough Total IgG and Specific Antibody Levels - IgG|Summary of trough total IgG concentration prior to specified infusion|Up to 1 year|||mg/dL||Standard Error|Mean
662791|NCT01814800|Secondary|Number of Days of Antibiotic Therapy (Prophylaxis and Treatment of Infection) - Per Subject-Year|Summary of the days of antibiotic therapy in the study for prophylaxis, as treatment for infections, and combined, per subject-year of treatment with RI-002|Up to 1 year|Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002||Days per subject-year|||Number
662792|NCT01814800|Secondary|Number of Days of Antibiotic Therapy (Prophylaxis and Treatment of Infection)|Summary of the days of antibiotic therapy in the study for prophylaxis, as treatment for infections, and combined|Up to 1 year|Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002||Days|||Number
662793|NCT01814800|Secondary|Days of Hospitalization Due to Infections - Per Subject-Year||Up to 1 year|Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002||Days per subject-year|||Number
662794|NCT01814800|Secondary|Days of Hospitalization Due to Infections||Up to 1 year|Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002||Days|||Number
662795|NCT01814800|Secondary|Number of Hospitalizations Due to Infections - Per Subject-Year||Up to 1 year|Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002||Hospitalizations per subject-year|||Number
662796|NCT01814800|Secondary|Number of Hospitalizations Due to Infections||Up to 1 year|Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002||Number of hospitalizations|||Number
662797|NCT01814800|Secondary|Time to Resolution of Infections - Infection Days Per Subject||Up to 1 year|Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002||Days per subject||Standard Deviation|Mean
662798|NCT01814800|Secondary|Time to Resolution of Infections - Duration Per Infection||Up to 1 year|Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002||Days||Standard Deviation|Mean
662799|NCT01814800|Secondary|Number of Unscheduled Visits to Physician/ER Due to Infections - Per Subject-Year||Up to 1 year|Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002||Number of Visits per subject-year|||Number
662800|NCT01814800|Secondary|Number of Unscheduled Visits to Physician/ER Due to Infections - Total Number of Visits||Up to 1 year|Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002||Number of Visits|||Number
662801|NCT01814800|Secondary|Number of Days Lost From Work/School/Daycare and Usual Activities Due to Infections and Their Treatment - Per Subject-Year||Up to 1 year|Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002||Days per subject-year|||Number
662802|NCT01814800|Secondary|Number of Days Lost From Work/School/Daycare and Usual Activities Due to Infections and Their Treatment - Combined Days Lost||Up to 1 year|Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002||Days|||Number
662803|NCT01814800|Secondary|Incidence of All Infections (Serious and Non-serious)||Up to 1 Year|Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002||events per subject-year|||Number
662804|NCT01814800|Primary|Number of Serious Bacterial Infections (SBIs) Per Subject Per Year (FDA Guidance for Industry (2008))|The primary objective of this study was to demonstrate that RI-002 (IGIV) reduces the frequency of serious bacterial infections (SBIs), as defined by the Diagnostic Criteria for Serious Infection Types guideline, in subjects with primary humoral immunodeficiency.|One year|Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002||SBIs/subject/year|||Number
662805|NCT01814787|Primary|Number of Children With Documented Risk Factors for Type 2 Diabetes|Number of children (ages 10 and older) with documented risk factors for type 2 diabetes (>85%BMI and 2 of 4 Risk Factors)|12 months|||Participants|||Count of Participants
662806|NCT01814774|Secondary|Botulinum Toxin Inter-injection Interval|Injection-interval was the time in weeks between injections of botulinum toxin.|2 Years|All participants who received onabotulinumtoxinA for 2 years and incobotulinumtoxinA for 2 years.||weeks||Standard Deviation|Mean
662807|NCT01814774|Secondary|Number of Participants With Adverse Events|An Adverse Event was any unfavorable and unintended sign, symptom, or disease documented in the medical chart that occurred after treatment with botulinum toxin, or pre-existing conditions that worsened during the retrospective period.|2 Years|Safety population included all participants who received at least one dose of botulinum toxin.||participants|||Number
662808|NCT01814774|Primary|Dose of Botulinum Toxin Used to Treat Blepharospasm|The average dose of botulinum toxin received per patient per year was calculated.|2 Years|Participants diagnosed with Blepharospasm who received onabotulinumtoxinA for 2 years and incobotulinumtoxinA for 2 years.||units per patient per year||95% Confidence Interval|Mean
662809|NCT01814774|Primary|Dose of Botulinum Toxin Used to Treat Cervical Dystonia|The average dose of botulinum toxin received per patient per year was calculated.|2 Years|Participants diagnosed with Cervical Dystonia who received onabotulinumtoxinA for 2 years and incobotulinumtoxinA for 2 years.||units per patient per year||95% Confidence Interval|Mean
662810|NCT01814761|Secondary|Overall Percent Change From Baseline in IOP|IOP is a measure of the fluid pressure inside the eye. A negative number change response indicates a reduction in IOP (improvement) and a positive number change response indicates an increase in IOP (worsening).|Baseline, Week 12|Intent-to-Treat: Enrolled patients who received at least one dose of study medication and who were not currently treated with Bimatoprost 0.01% at the time of enrollment||Percentage Change||95% Confidence Interval|Mean
662811|NCT01814761|Primary|Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale|Hyperemia is the engorgement of the blood vessels (redness) of the eye. Hyperemia is graded in the study eye on a 5-point scale where 0=None (Normal), 0.5=Trace (Trace reddish pink with no more than slight perilimbal injection), 1=Mild (Mild flush reddish color), 2=Moderate (Bright red color), and 3=Severe (Deep, bright, diffuse redness). The numbers of patients in each severity grade are presented.|12 Weeks|Intent-to-Treat: Enrolled patients who received at least one dose of study medication and who were not currently treated with Bimatoprost 0.01% at the time of enrollment||Patients|||Number
662812|NCT01814761|Secondary|Percentage of Patients Who Discontinue Due to an Adverse Event|An adverse event is any untoward medical occurrence associated with the use of a drug, whether or not considered drug related.|12 Weeks|Intent-to-Treat: Enrolled patients who received at least one dose of study medication and who were not currently treated with Bimatoprost 0.01% at the time of enrollment||Percentage of Patients|||Number
662813|NCT01814761|Secondary|Change From Baseline in Intraocular Pressure (IOP) in the Study Eye|IOP is a measure of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening).|Baseline, Week 12|Intent-to-Treat: Enrolled patients who received at least one dose of study medication and who were not currently treated with Bimatoprost 0.01% at the time of enrollment||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
662814|NCT01814748|Secondary|Percentage of Participants Who Required Glycemic Rescue by Week 24|"Participants exceeding pre-specified glycemic thresholds after starting the double-blind treatment period may have received rescue therapy (per protocol) with open-label metformin initiated by the investigator.
This analysis may have been confounded by the use of metformin prohibited by the protocol (see efficacy results description above)."|Up to Week 24|All randomized participants.||Percentage of participants|||Number
662815|NCT01814748|Secondary|Percentage of Participants Attaining A1C Glycemic Goals of <6.5% (48 mmol/Mol) at Week 24|"Percentage of participants was estimated using standard multiple imputation techniques (cLDA). Within-group CIs were calculated via the Wilson score method.
The unexpected absence of a treatment effect in this study led to investigations that included measurement of metformin levels in available samples collected for future research during the study. Of the 92 participants with samples who had not been rescued with metformin, 57% (25/44) in the placebo group and 29% (14/48) in the omarigliptin group had detectable metformin, indicating the use of metformin that was prohibited by the protocol. The use of metformin prohibited by the protocol was without investigator knowledge and is a confounding factor impacting the ability to draw any conclusions regarding the efficacy results from this study."|Week 24|FAS population comprised all participants who received at least one dose of study treatment and had a baseline measurement or a post-randomization measurement for the analysis endpoint.||Percentage of participants||95% Confidence Interval|Number
662816|NCT01814748|Secondary|Percentage of Participants Attaining A1C Glycemic Goals of <7.0% at Week 24|"Percentage of participants was estimated using standard multiple imputation techniques (constrained longitudinal data analysis [cLDA] model). Within-group confidence intervals (CIs) were calculated via the Wilson score method.
The unexpected absence of a treatment effect in this study led to investigations that included measurement of metformin levels in available samples collected for future research during the study. Of the 92 participants with samples who had not been rescued with metformin, 57% (25/44) in the placebo group and 29% (14/48) in the omarigliptin group had detectable metformin, indicating the use of metformin that was prohibited by the protocol. The use of metformin prohibited by the protocol was without investigator knowledge and is a confounding factor impacting the ability to draw any conclusions regarding the efficacy results from this study."|Week 24|FAS population comprised all participants who received at least one dose of study treatment and had a baseline measurement or a post-randomization measurement for the analysis endpoint.||Percentage of participants||95% Confidence Interval|Number
662817|NCT01814748|Secondary|Change in Baseline in FPG at Week 24|"Blood glucose was measured on a fasting basis.
The unexpected absence of a treatment effect in this study led to investigations that included measurement of metformin levels in available samples collected for future research during the study. Of the 92 participants with samples who had not been rescued with metformin, 57% (25/44) in the placebo group and 29% (14/48) in the omarigliptin group had detectable metformin, indicating the use of metformin that was prohibited by the protocol. The use of metformin prohibited by the protocol was without investigator knowledge and is a confounding factor impacting the ability to draw any conclusions regarding the efficacy results from this study."|Baseline and Week 24|FAS population comprised all participants who received at least one dose of study treatment and had a baseline measurement or a post-randomization measurement for the analysis endpoint.||mg/dL||95% Confidence Interval|Least Squares Mean
662818|NCT01814748|Secondary|Change From Baseline in 2-hr PMG at Week 24|"Blood glucose was measured 120 minutes from start of meal.
The unexpected absence of a treatment effect in this study led to investigations that included measurement of metformin levels in available samples collected for future research during the study. Of the 92 participants with samples who had not been rescued with metformin, 57% (25/44) in the placebo group and 29% (14/48) in the omarigliptin group had detectable metformin, indicating the use of metformin that was prohibited by the protocol. The use of metformin prohibited by the protocol was without investigator knowledge and is a confounding factor impacting the ability to draw any conclusions regarding the efficacy results from this study."|Baseline and Week 24|FAS population comprised all participants who received at least one dose of study treatment and had a baseline measurement or a post-randomization measurement for the analysis endpoint.||mg/dL||95% Confidence Interval|Least Squares Mean
662819|NCT01814748|Primary|Percentage of Participants Who Discontinued Study Drug Due to an AE|"An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Data presented exclude data following the initiation of glycemic rescue.
The safety database was analyzed in a standard fashion in the APaT population for all participants who took at least one dose of study medication. This analysis may have been confounded by the use of metformin prohibited by the protocol (see efficacy results description above)."|Up to Week 24|APaT population included all randomized participants who received at least one dose of study medication.||Percentage of participants|||Number
662820|NCT01814748|Primary|Percentage of Participants Who Experienced at Least One Adverse Event (AE)|"An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Data presented exclude data following the initiation of glycemic rescue.
The safety database was analyzed in a standard fashion in the all participants as treated (APaT) population for all participants who took at least one dose of study medication. This analysis may have been confounded by the use of metformin prohibited by the protocol (see efficacy results description above)."|Up to Week 27|APaT population included all randomized participants who received at least one dose of study medication.||Percentage of participants|||Number
663224|NCT01808209|Primary|Visual Acuity logMAR|Assessment of Monocular (MHCVA) Right eye (OD), left eye (OS) and Binocular High Contrast Distance Visual Acuity (BHCVA). Collected at baseline for habitual lens. logMAR.|Baseline|||logMAR||Standard Deviation|Mean
662821|NCT01814748|Primary|Change From Baseline in A1C at Week 24|"A1C (%) is used to report average blood glucose levels over prolonged periods of time.
The unexpected absence of a treatment effect in this study led to investigations that included measurement of metformin levels in available samples collected for future research during the study. Of the 92 participants with samples who had not been rescued with metformin, 57% (25/44) in the placebo group and 29% (14/48) in the omarigliptin group had detectable metformin, indicating the use of metformin that was prohibited by the protocol. The use of metformin prohibited by the protocol was without investigator knowledge and is a confounding factor impacting the ability to draw any conclusions regarding the efficacy results from this study."|Baseline and Week 24|Full analysis set (FAS) population comprised all participants who received at least one dose of study treatment and had a baseline measurement or a post-randomization measurement for the analysis endpoint.||Percent||95% Confidence Interval|Least Squares Mean
662822|NCT01814722|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI)|DLQI is a 10-question dermatology-specific QOL questionnaire, which is calculated by summing the score of each question, resulting in a maximum of 30, and a minimum of 0. Higher scores mean the QOL is more impaired.|Baseline and Week 4 Follow-up|Analyses were not performed due to too few participants.|||||
662823|NCT01814722|Secondary|Change From Baseline in HIV Symptom Index (HIV-SI)|HIV-SI measures the frequency and level of bothersome HIV and HIV treatment-related symptoms, including nervous symptoms (dizziness, somnolence, trouble remembering), gastrointestinal symptoms (nausea, gas/bloating, diarrhea) and pain (hand/foot, muscle/joint). The 20-item questionnaire asks whether respondents experienced any one of these symptoms within the past 4 weeks, and if they did, what the relative level of bother for each symptom was, based on a 5-point Likert scale. The maximum sum of scores is 80; the minimum is 0; with a higher score indicating greater symptom distress.|Baseline and Week 4 Follow-up|Analyses were not performed due to too few participants.|||||
662824|NCT01814722|Secondary|Change From Baseline in Depression, Anxiety, and Stress Scale (DASS-21)|DASS-21 is comprised of questionnaires for three separate scales measuring Depression, Anxiety and Stress. The depression scale is scored by summing the responses of each question, multiplying by 2 and then scoring on a scale ranging from a minimum of 0 to a maximum of 28+, with higher scores indicating greater severity. The anxiety scale is scored by summing the responses of each question, multiplying by 2 and then scoring on a scale ranging from a minimum of 0 to a maximum of 20+, with higher scores indicating greater severity. The stress scale is scored by summing the responses of each question, multiplying by 2 and then scoring on a scale ranging from a minimum of 0 to a maximum of 37+, with higher scores indicating greater severity.|Baseline and Week 4 Follow-up|Analyses were not performed due to too few participants.|||||
662825|NCT01814722|Primary|Medical Outcomes Study-HIV (MOS-HIV) Health Survey Scores|The MOS-HIV scale is a 35-item measure of health related quality of life (QOL) questionnaire which assesses 10 dimensions of health (general health perceptions, pain, physical functioning, role functioning, social functioning, mental health, energy/fatifue, cognitive function, health distress and QOL), as well as a single item to assess health transition. In addition to these subscales, a Physical Health Summary score (PHS) and a Mental Health Summary score (MHS) is calculated using a method where the summary scores are transformed to a standardized scale with a norm of 50 and a standard deviation of 10 in the sample in which the summary scores were developed. The subscales of the MOS-HIV are scored as summed rating scales ranging from a minimum of 0, to a maximum of 100, where higher scores indicate better health.|Week 4 Follow-up|Analyses were not performed due to too few participants.|||||
662826|NCT01814696|Secondary|Minnesota Living With Heart Failure Questionnaire (MLHFQ) Total Summary Score|"Health-related quality of life is measured using the Minnesota Living with Heart Failure Questionnaire (MLHFQ). The questionnaire consists of 21 items that assess the impact of HF and HF treatment on key physical, emotional, and social dimensions of a patient’s life during the past four weeks. Responses are coded from 0 = does not apply and 1 = very little to 5 = very much.
A higher score represents a greater negative HR-related impact on quality of life."|Baseline, end 3 months|||units on a scale||Standard Deviation|Mean
662827|NCT01814696|Secondary|Hospitalization, Length of Stay (Days)||3 months|Intention to treat analysis.||days||Standard Deviation|Mean
662828|NCT01814696|Secondary|Number of Hospitalization Visits.||3 months|Intention to treat analysis.||participants|||Number
662829|NCT01814696|Secondary|Number of Emergency Department (ED) Visits.||3 months|Intention to treat analysis.||participants|||Number
662830|NCT01814696|Secondary|Number of Participants With 1 or More Hospitalizations.||3 months|Intention to treat analysis.||participants|||Number
662831|NCT01814696|Secondary|Number of Participants With 1 or More Emergency Department (ED) Visits.||3 months|Intention to treat analysis.||participants|||Number
662832|NCT01814696|Primary|Morisky Medication Adherence Survey, 8-Items (MMAS-8)|Subject reported medication adherence. The Morisky Medication Adherence Scale (MMAS) is a valid and reliable instrument that consists of 8 items that measure medication adherence. Responses are summed from the 8-items to yield 3 categories of adherence: 0 = high adherence, 1-2 = medium adherence, and 3-8 = low adherence.|3 months|Participants who completed questions on enrollment and closeout survey.||participants|||Number
662833|NCT01814670|Secondary|Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Subject Assessed Facial Wrinkle Scale of Glabellar Rhytides at Rest|The Subject assessed the severity of his/her glabellar rhytides at rest using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a ≥ 1-grade improvement from Day 1 is reported.|Day 1, Day 14, Day 30, Day 90, Day 120|Intent-to-Treat: all eligible subjects enrolled in the study who received study treatment (BOTOX®) at Day 1||Percentage of Subjects|||Number
662834|NCT01814670|Secondary|Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Investigator Assessed Facial Wrinkle Scale of Glabellar Rhytides at Rest|The Investigator assessed the severity of the subject's glabellar rhytides at rest using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a ≥ 1-grade improvement from Day 1 is reported.|Day 1, Day 14, Day 30, Day 90, Day 120|Intent-to-Treat: all eligible subjects enrolled in the study who received study treatment (BOTOX®) at Day 1||Percentage of Subjects|||Number
663057|NCT01809834|Secondary|Investigator's Objective Assessment of Anterior Ocular Physiological Response, Cornea (Biomicroscopy)|Investigators assigned an anterior ocular physiological response grade by biomicroscopy assessment with corneal staining (grading scale, 0-4, 0=none, 4=severe) Change over time measured at baseline (screening and dispensing visit), 12-hours, 1-week|Baseline, 12-hours, 1-week|||units on a scale|Participants|Standard Deviation|Mean
662835|NCT01814670|Secondary|Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Subject Assessed Facial Wrinkle Scale of Glabellar Rhytides at Maximum Contraction|The subject assessed the severity of his/her glabellar rhytides at maximum contraction using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a ≥ 1-grade improvement from Day 1 is reported.|Day 1, Day 14, Day 30, Day 90, Day 120|Intent-to-Treat: all eligible subjects enrolled in the study who received study treatment (BOTOX®) at Day 1 and had data at the noted time point||Percentage of Subjects|||Number
662836|NCT01814670|Secondary|Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Investigator Assessed Facial Wrinkle Scale of Glabellar Rhytides at Maximum Contraction|The Investigator assessed the severity of the subject's glabellar rhytides at maximum contraction using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a ≥ 1-grade improvement from Day 1 is reported.|Day 1, Day 14, Day 90, Day 120|Intent-to-Treat: all eligible subjects enrolled in the study who received study treatment (BOTOX®) at Day 1||Percentage of Subjects|||Number
662837|NCT01814670|Primary|Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Investigator Assessed Facial Wrinkle Scale of Glabellar Rhytides at Maximum Contraction|The Investigator assessed the severity of the subject's glabellar rhytides at maximum contraction using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a ≥ 1-grade improvement from Day 1 is reported.|Day 1, Day 30|Intent-to-Treat: all eligible subjects enrolled in the study who received study treatment (BOTOX®) at Day 1||Percentage of Subjects|||Number
662838|NCT01814553|Secondary|PFS|"Progression-free survival (PFS). PFS was defined as the time from the start of treatment to an event occurred. In the analyses for the PFS endpoint, an event was defined as disease progression or death, whichever occurred earlier. Data for patients who did not die or progress during the trial were censored at the time of afatinib discontinuation or transition to commercially available afatinib. Median PFS is estimated using Kaplan-Meier method.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1)."|Every 08 weeks during the first 6 months of treatment, and every 12 weeks thereafter until the end of treatment.|Treated Set||Months||95% Confidence Interval|Median
662839|NCT01814553|Secondary|Changes in Intensity of Diarrhea Over Time|Percentage of participants with grade 2 or higher diarrhea each week for the first 3 cycles of afatinib treatment|Up to 12 weeks (equivalent to 3 courses)|Treated set||Percentage of participants|||Number
662840|NCT01814553|Secondary|Duration of First Episode of Diarrhea Grade 2 or Higher|"Duration of first episode of diarrhea grade 2 or higher.
Please note that the nine patients experienced diarrhea episodes that were not managed according to the protocol specified afatinib treatment interruptions and dose reductions. No patients were excluded from the primary analysis."|From first drug administration until end of third treatment course, up to 84 days.|Treated set||days||Standard Deviation|Mean
662841|NCT01814553|Secondary|Time to Initial Onset of Diarrhea Grade 2 or Higher|Time to initial onset of diarrhea grade 2 or higher|From first drug administration until end of third treatment course, up to 84 days.|Treated set||days||Standard Deviation|Mean
662842|NCT01814553|Primary|Occurence of CTCAE Grade >= 2 Diarrhea|Overall incidence of patients who experienced diarrhea during the first three courses of afatinib treatment.|From first drug administration until 28 days after the end of third treatment course, up to 84 days.|Treated set||Percentage of participants|||Number
662843|NCT01814397|Other Pre-specified|Estradiol Concentration Assessments at Baseline and After 3 Months of Aromatase Inhibitor Therapy|Estradiol is being assessed using an ultrasensitive gas chromatography tandem mass spectroscopy-based assay. The lower limit of detection of the assay is 0.625 pg/ml. For patients whose serum estradiol concentrations were below the lower limit of detection, the value of 0.625 pg/ml was used to calculate the mean estradiol concentration and standard deviation at both baseline and 3 months.|Baseline, 3 months|||pg/ml||Standard Deviation|Mean
662844|NCT01814397|Other Pre-specified|Mean Baseline Patient-reported Symptom Measures for Patients Who Were Persistent and Nonpersistent With Aromatase Inhibitor Therapy During the First 6 Months of Treatment|Patients completed 4 measures at baseline, before aromatase inhibitor therapy initiation. (1) Depression: Center for Epidemiologic Studies-Depression, scores 0-60, higher scores reflect more depression. (2) Pain: 7 day Pain Diary, scores 0-10, higher scores reflect more pain. (3) Fatigue: Multidimensional Fatigue Inventory, scores 4-20, higher scores reflect more fatigue. (4) Sleep: Medical Outcomes Study-Sleep, scores 0-100, higher scores reflect worse sleep. Persistence with aromatase inhibitor therapy was assessed at the 6 month timepoint. Mean baseline values for each measure were calculated for the cohort that persisted with aromatase inhibitor therapy and the cohort that was non-persistent.|Baseline patient-reported outcomes measures, 6 month persistence with therapy|||units on a scale||Standard Deviation|Mean
662845|NCT01814397|Secondary|Mean Conditioned Pain Modulation Assessed at Baseline, 3 Months, and 6 Months|To assess conditioned pain modulation, pressure equivalent to the patient's Pain50 was applied to the non-dominant thumbnail for 30 seconds (test stimulus), and the patient rated the intensity of the pressure on a 0-100 pain scale at 10 second intervals. Ten minutes later pressure (conditioning stimulus) was continuously applied to the dominant thumbnail for 60 seconds at the same Pain50 intensity. After 30 seconds, the test stimulus was again applied to the non-dominant thumbnail for 30 seconds and the patient rated the intensity every 10 seconds. Conditioned pain modulation magnitude was calculated as the difference (second minus first) in the mean of the 3 pain ratings to the test stimulus applied prior to and during the conditioning stimulus. Conditioned pain modulation was assessed at baseline, 3 months, and 6 months. Change over that time period was assessed. Higher conditioned pain modulation values indicate less efficient conditioned pain modulation.|Baseline, 3 months, 6 months|||units on a scale (0-100 pain scale)||Standard Deviation|Mean
662846|NCT01814397|Primary|Mean Pain50 Assessed at Baseline, 3 Months and 6 Months|Patients rated the intensity of each pressure sensation using a 0 to 100 numerical rating scale (0 = no pain, 100 = worst pain imaginable). Pain50 was defined as the amount of applied pressure in kilograms per square centimeter that evoked a pain intensity rating of 50 out of 100. Pain50 was assessed at baseline, 3 months, and 6 months. Change in Pain50 with estrogen depletion was determined.|Baseline, 3 months, 6 months|||kg/cm^2||Standard Deviation|Mean
662847|NCT01814332|Secondary|Safety, Measured by the Number of Subjects That Experienced an Adverse Event|The occurrence of adverse events will be recorded at the end of 6 weeks.|Baseline, Week 6|||participants|||Number
662848|NCT01814332|Secondary|Efficacy, Measured by Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Score|The MADRS is a ten-item clinician-administered questionnaire used to measure the severity of depressive symptoms in patients with depressive disorders. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. Change is the difference in scores between baseline and 6 weeks.|Baseline, Week 6|||Score on a scale||Standard Deviation|Mean
662849|NCT01814332|Secondary|Efficacy, Measured by Response Rate of at Least 50% Improvement in CAPS Score at the End of 6 Weeks as Compared to Baseline|The number of participants that showed at least a 50% reduction in CAPS scores from their baseline visit at the end of 6 weeks were measured as having a response to the treatment. The CAPS is a semi-structured clinical interview providing a measure of the severity of PTSD symptoms. A severity score is calculated by summing the frequency and intensity scores for each of the 17 DSM-IV criteria symptoms. Scores may range from 0 (no symptoms) to 136 (severe symptoms).|Baseline, Week 6|||participants|||Number
662850|NCT01814332|Primary|Efficacy, Measured by Change in the Clinician-Administered PTSD Scale (CAPS) Score|The CAPS is a semi-structured clinical interview providing a measure of the severity of PTSD symptoms. A severity score is calculated by summing the frequency and intensity scores for each of the 17 DSM-IV criteria symptoms. The severity of symptoms is rated on a scale from 0-4, where, 0 = Absent, 1 = Mild/subthreshold; 2 = Moderate/ threshold, 3 = Severe/markedly elevated and 4 = Extreme/ incapacitating. Scores may range from 0 (no symptoms) to 136 (severe symptoms). Change is the difference in scores between baseline and 6 weeks.|Baseline, 6 weeks|Intent to treat analysis was performed using maximum likelihood estimation with mixed models to include all observations.||score on a scale||Standard Deviation|Mean
662851|NCT01814241|Other Pre-specified|Change in Immunoglobin G4 (IgG4) to Peanut From Baseline Until Desensitization Food Challenge|The investigation of mechanistic changes that occur in the immune system dover the duration of the study - Immunoglobin G4 (IgG4) to peanut|44 weeks|Blood work was not able to be obtained from 1 of 16 evaluable subjects||mg/dL of IgG4||Full Range|Median
662852|NCT01814241|Other Pre-specified|Change in Peanut Specific Immunoglobin E (IgE) From Baseline Until Desensitization Food Challenge|The investigation of mechanistic changes that occur in the immune system over the duration of the study - Peanut specific immunoglobin E (IgE)|44 weeks|Blood work was not able to be obtained from 1 of 16 evaluable subjects||kU/L of peanut-specific IgE||Full Range|Median
662853|NCT01814241|Other Pre-specified|Change From Baseline in the Wheal Diameter, as Assessed by the Skin Prick Test (SPT) to Peanut|Allergic reactivity of mast cells is assessed by skin prick testing through measurement of the wheal diameter after exposure to peanut. This outcome measure reports the change in skin prick test wheal diameter from baseline through the end of the treatment period.|44 weeks|||mm||Full Range|Mean
662854|NCT01814241|Secondary|Percentage of Subjects Who Maintain Desensitization Once OIT is Stopped|The percentage of subjects who maintain desensitization once the OIT is withdrawn at 1, 2, 3, and 4 week intervals.|4 weeks|||percentage of participants|||Number
662855|NCT01814241|Primary|Percentage of Subjects Who Develop Desensitization|The percentage of peanut allergic subjects who develop desensitization as defined by being able to consume 5000mg of peanut protein during a double blind food challenge after completing a build-up phase of peanut OIT.|40 weeks|||percentage of participants|||Number
662856|NCT01814137|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|Change from baseline in FPG after 26 weeks of treatment. FPG was analysed on blood samples from fasting subjects which were analysed centrally.|Week 0, week 26|The FAS included all randomised subjects and missing data was imputed using LOCF. One subject in each arm did not have FPG values from week 0.||mmol/L||Standard Deviation|Mean
662857|NCT01814137|Secondary|Number of Treatment Emergent Nocturnal (00:01-05:59) Confirmed Hypoglycaemic Episodes|Hypoglycaemic episodes were defined as nocturnal if the time of onset was between 00:01 and 05:59 hours inclusive. Confirmed hypoglycaemic episodes were defined as severe hypoglycaemic episodes and/or a measured PG below 3.1 mmol/L (below 56 mg/dL).|During 26 weeks of treatment|The SAS included all subjects receiving at least one dose of the investigational product.||episodes|||Number
662858|NCT01814137|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes|"Confirmed hypoglycaemic episodes were defined as episodes that are either:
severe (i.e., an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions) or
biochemically confirmed by a PG value of <3.1 mmol/L (56 mg/dL), with or without symptoms consistent with hypoglycaemia."|During 26 weeks of treatment|The SAS included all subjects receiving at least one dose of the investigational product.||episodes|||Number
662859|NCT01814137|Secondary|Incidence of Treatment Emergent Adverse Events (TEAEs)|A treatment emergent adverse event was defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last dose of the trial product.|During 26 weeks of treatment|Safety analysis set (SAS) included all subjects receiving at least one dose of the investigational product.||number of events|||Number
662860|NCT01814137|Primary|Change From Baseline in HbA1c (Glycosylated Haemoglobin)|Change from baseline in HbA1c after 26 weeks of treatment|Week 0, week 26|The FAS included all randomised subjects and missing data was imputed using last observation carried forward (LOCF).||percentage of glycosylated haemoglobin||Standard Error|Least Squares Mean
662861|NCT01814046|Other Pre-specified|Count of Participants With Changes in Visual Symptoms|Visual symptoms (e.g., blurred) were evaluated and if changes had occurred from baseline, i.e. in visual acuity, an ophthalmologic consult was performed.|6 weeks (+/- 2 weeks)|One out of 24 subjects had blurred vision.||Participants|||Count of Participants
662862|NCT01814046|Secondary|Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0)|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|46 months and 12 days|||Participants|||Count of Participants
663225|NCT01808209|Primary|Overall Satisfaction|Participant rating for overall satisfaction. Collected at 1 week for study lenses. (0-100, 0= extremely dissatisfied and 100= extremely satisfied).|1 Week|||units on a scale||Standard Deviation|Mean
662863|NCT01814046|Primary|Percentage of Participants With Ocular Melanoma Treated With Young Tumor Infiltrating Lymphocytes (TIL) With or Without High Dose Aldesleukin With an Objective Response Rate of (Complete Response (CR) + Partial Response (PR))|Objective response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.|approximately 3 years|||percentage of participants||95% Confidence Interval|Number
662864|NCT01813890|Secondary|Patient Global Impression of Change (PGI-C) Score at 72 Hours|The PGI-C is a 7-point scale that requires the participants to assess how much their illness has improved or worsened relative to a baseline state at the beginning of the intervention. The response options are: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; and 7=very much worse. Higher scores indicate worsening.|Baseline (Day 1) and 72 hours|ITT analysis set, which included all randomly assigned participants with at least 1 dose of study medication. Last-observation-carried-forward imputation method was used for missing values.||Percentage of participants|||Number
662865|NCT01813890|Secondary|Sum of Pain Relief and Pain Intensity Differences (SPRID) Over 12, 24, 48, and 72 Hours|Participants rated pain relief on 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Pain Intensity (PI) was assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. PRID is the sum of pain relief and PID at the same assessment time. SPRID was calculated as the time-weighted Sum of PRID scores over 12, 24, 48, and 72 hours. Total score ranges from -120 (worst) to 168 (best) for SPRID12, -240 (worst) to 336 (best) for SPRID24, -480 (worst) to 672 (best) for SPRID48, and -720 (worst) to 1008 (best) for SPRID72. A higher value of SPRID indicates greater pain relief.|12, 24, 48 and 72 hours|ITT analysis set, which included all randomly assigned participants with at least 1 dose of study medication. Last-observation-carried-forward imputation method was used for missing values.||units on a scale||Standard Deviation|Mean
662866|NCT01813890|Secondary|Total Pain Relief (TOTPAR) Over 12, 24, 48, and 72 Hours|Participants rated pain relief on 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum of pain relief scores up to Hour 12, 24, 48, and 72. Total score ranges from 0 (worst) to 48 (best) for TOTPAR12, 0 (worst) to 96 (best) for TOTPAR24, 0 (worst) to 192 (best) for TOTPAR48, and 0 (worst) to 288 (best) for TOTPAR72. A higher value of TOTPAR indicated greater pain relief.|12, 24, 48, and 72 hours|ITT analysis set, which included all randomly assigned participants with at least 1 dose of study medication. Last-observation-carried-forward imputation method was used for missing values.||units on a scale||Standard Deviation|Mean
662867|NCT01813890|Secondary|Sum of Pain Intensity Differences (SPID) Over 12, 24 and 72 Hours|Pain Intensity (PI) was assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted Sum of PID scores over 12, 24, and 72 hours. Total score ranges from -120 (worst) to 120 (best) for SPID12, -240 (worst) to 240 (best) for SPID24, -720 (worst) to 720 (best) for SPID72. A higher value of SPID indicates greater pain relief.|12, 24 and 72 hours|ITT analysis set, which included all randomly assigned participants with at least 1 dose of study medication. Last-observation-carried-forward imputation method was used for missing values.||units on a scale||Standard Deviation|Mean
662868|NCT01813890|Secondary|Response Rate for 50 Percent or Greater Reduction in Pain Intensity at 12, 24, 48 and 72 Hours|Response rate was defined as the percentage of participants with a 50 percent or greater reduction in pain intensity from baseline to 12, 24, 48, and 72 hours. Pain intensity was assessed on a 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Participants with no assessment at the given time point, who used an analgesic medication prior to the time point, or who had worse pain intensity at the time point compared to baseline were assigned a percent reduction of 0 percent.|12, 24, 48 and 72 hours|ITT analysis set, which included all randomly assigned participants with at least 1 dose of study medication.||Percentage of Participants|||Number
662869|NCT01813890|Secondary|Response Rate for 30 Percent or Greater Reduction in Pain Intensity at 12, 24, 48 and 72 Hours|Response rate was defined as the percentage of participants with a 30 percent or greater reduction in pain intensity from baseline to 12, 24, 48, and 72 hours. Pain intensity was assessed on a 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Participants with no assessment at the given time point, who used an analgesic medication prior to the time point, or who had worse pain intensity at the time point compared to baseline were assigned a percent reduction of 0 percent.|12, 24, 48 and 72 hours|ITT analysis set, which included all randomly assigned participants with at least 1 dose of study medication.||Percentage of Participants|||Number
662870|NCT01813890|Secondary|Time to First Rescue Medication Use|Rescue medication was defined as any analgesic medication used for participants discontinued due to lack of efficacy (including those started at time of discontinuation) or analgesic medication used during the double-blind period for completed participants.|up to 48 hours|ITT analysis set, which included all randomly assigned participants with at least 1 dose of study medication.||Hours||Inter-Quartile Range|Median
662871|NCT01813890|Primary|Sum of Pain Intensity Difference (SPID) Over 48 Hours|Pain Intensity (PI) was assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted Sum of PID scores over 48 hours. Total score ranges from -480 (worst) to 480 (best) for SPID48. A higher value of SPID indicates greater pain relief.|48 hours|Intent-to-treat (ITT) analysis set, which included all randomly assigned participants with at least 1 dose of study medication. Last-observation-carried-forward imputation method was used for missing values.||units on a scale||Standard Deviation|Mean
662897|NCT01813019|Secondary|Y-BOCS Reduction in Total Score From Baseline|If a subject demonstrates at least 25% reduction in total Y-BOCS from Baseline then they will be classed as a responder whereas if a subject has a reduction in Y-BOCS of less than 25% then they will be categorized as a nonresponder.|16 weeks|The study was terminated due to an interim analysis of the primary efficacy outcome. Study was prematurely terminated at the time of the first Interim Analysis (IA) as the study did not meet its primary efficacy objective therefore secondary objective was not measured.|||||
662872|NCT01813721|Secondary|Percentage of Participants With an Investigator-assessed FN Risk at or Above the Investigator Self-reported FN-risk Intervention Threshold Who Were Planned to Receive G-CSF PP|At Baseline investigators recorded the FN risk threshold score at which they would use G-CSF PP in their usual clinical practice. For each enrolled participant, the investigator documented their final estimated FN risk score as a percentage based on the participant’s medical history and standard of care assessments (their routine practice for assessing this risk), and a decision as to whether G-CSF PP would be administered in Cycle 1.|At Baseline and at enrolment, prior to chemotherapy initiation.|Primary analysis set, participants with investigator-assessed FN risk at or above the investigator FN-risk intervention threshold||percentage of participants|||Number
662873|NCT01813721|Secondary|Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type|"Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment was collected in this study.
To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.
ECOG = Eastern Cooperative Oncology Group."|At enrolment, prior to chemotherapy initiation.|Primary analysis set; analysis only included subgroups with at least 100 participants.||percentage of participants||95% Confidence Interval|Number
662874|NCT01813721|Secondary|Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type|"Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment was collected in this study.
To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.
ECOG = Eastern Cooperative Oncology Group."|At enrolment, prior to chemotherapy initiation.|Primary analysis set; analysis only included subgroups with at least 100 participants.||percentage of participants||95% Confidence Interval|Number
662875|NCT01813721|Secondary|Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Number of Years in Clinical Practice in Oncology / Hematology|"Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment was collected in this study.
To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.
ECOG = Eastern Cooperative Oncology Group."|At enrolment, prior to chemotherapy initiation.|Primary analysis set; analysis only included subgroups with at least 100 participants.||percentage of participants||95% Confidence Interval|Number
662876|NCT01813721|Secondary|Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty|"Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment was collected in this study.
To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.
ECOG = Eastern Cooperative Oncology Group."|At enrolment, prior to chemotherapy initiation.|Primary analysis set; analysis only included subgroups with at least 100 participants.||percentage of participants||95% Confidence Interval|Number
662877|NCT01813721|Secondary|Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country|"Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment was collected in this study.
To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.
ECOG = Eastern Cooperative Oncology Group."|At enrolment, prior to chemotherapy initiation.|Primary analysis set; analysis only includes subgroups with at least 100 participants.||percentage of participants||95% Confidence Interval|Number
662878|NCT01813721|Secondary|Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type|During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of risk factors on a source document worksheet, and asked to rank the factors that they considered to be the most important when assessing overall FN risk. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group.|Assessed at Baseline, prior to participant enrolment.|Primary analysis set - investigators (PASI); analysis was only performed for subgroups containing at least 40 investigators.||percentage of investigators|Investigators|95% Confidence Interval|Number
662879|NCT01813721|Secondary|Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Number of Years in Clinical Practice in Oncology / Hematology|During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of risk factors on a source document worksheet, and asked to rank the risk factors that they considered to be the most important when assessing overall FN risk. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group.|Assessed at Baseline, prior to participant enrolment.|Primary analysis set - investigators (PASI); analysis was only performed for subgroups containing at least 40 investigators.||percentage of investigators|Investigators|95% Confidence Interval|Number
662933|NCT01812044|Secondary|Average Time to Discharge||0-150 minutes post-operative|||minutes||Standard Deviation|Mean
663226|NCT01808209|Primary|Overall Satisfaction|Participant rating for overall satisfaction. Collected at baseline for habitual lenses. (0-100, 0= extremely dissatisfied and 100= extremely satisfied).|Baseline|||units on a scale||Standard Deviation|Mean
662880|NCT01813721|Secondary|Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Clinical Specialty|During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of risk factors on a source document worksheet, and asked to rankt the risk factors that they considered to be the most important when assessing overall FN risk. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group. Subgroup analyses were performed where a subgroup contained at least 40 investigators. Results are reported for medical oncologists as this was the only specialty that contained at least 40 investigators.|Assessed at Baseline, prior to participant enrolment.|Primary analysis set - investigators (PASI); analysis was only performed for subgroups containing at least 40 investigators.||percentage of investigators|Investigators|95% Confidence Interval|Number
662881|NCT01813721|Secondary|Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type|"For each participant, the investigator ranked the risk factors that they considered to be the most important factors that they considered when deciding whether to use G-CSF PP treatment or not.
To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.
ECOG = Eastern Cooperative Oncology Group."|At enrolment, prior to chemotherapy initiation.|Primary analysis set. Subgroup analyses were only performed in subgroups with at least 100 participants.||percentage of participants||95% Confidence Interval|Number
662882|NCT01813721|Secondary|Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type|"For each participant, the investigator ranked the risk factors that they considered to be the most important factors that they considered when deciding whether to use G-CSF PP treatment or not.
To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.
ECOG = Eastern Cooperative Oncology Group."|At enrolment, prior to chemotherapy initiation.|Primary analysis set. Subgroup analyses were only performed in subgroups with at least 100 participants.||percentage of participants||95% Confidence Interval|Number
662883|NCT01813721|Secondary|Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology|"For each participant, the investigator ranked the risk factors that they considered to be the most important factors that they considered when deciding whether to use G-CSF PP treatment or not.
To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.
ECOG = Eastern Cooperative Oncology Group."|At enrolment, prior to chemotherapy initiation.|Primary analysis set. Subgroup analyses were only performed in subgroups with at least 100 participants.||percentage of participants||95% Confidence Interval|Number
662884|NCT01813721|Secondary|Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Clinical Specialty|"For each participant, the investigator ranked the risk factors that they considered to be the most important factors that they considered when deciding whether to use G-CSF PP treatment or not.
To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.
ECOG = Eastern Cooperative Oncology Group."|At enrolment, prior to chemotherapy initiation.|Primary analysis set. Subgroup analyses were only performed in subgroups with at least 100 participants.||percentage of participants||95% Confidence Interval|Number
662885|NCT01813721|Secondary|Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country|"For each participant, the investigator ranked the risk factors that they considered to be the most important factors that they considered when deciding whether to use G-CSF PP treatment or not.
To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.
ECOG = Eastern Cooperative Oncology Group."|At enrolment, prior to chemotherapy initiation.|Primary analysis set; subgroup analyses were only performed on subgroups (countries) with at least 100 participants.||percentage of participants||95% Confidence Interval|Number
662886|NCT01813721|Secondary|Percentage of Participants for Whom Each Factor Was Ranked in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important|For each participant, the investigator ranked the factors that they considered to be the most important factors that they considered when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group.|At enrolment, prior to chemotherapy initiation.|Primary analysis set||percentage of participants||95% Confidence Interval|Number
662887|NCT01813721|Secondary|Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Institution Type|During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of factors on a source document worksheet, and asked to rank the factors that they considered to be the most important when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. Subgroup analyses were performed where a subgroup contained at least 40 investigators. ECOG = Eastern Cooperative Oncology Group.|Assessed at baseline, prior to participant enrolment.|Primary analysis set - investigators; analysis only includes subgroups with at least 40 investigators.||percentage of investigators|Investigators|95% Confidence Interval|Number
662999|NCT01811186|Secondary|The Change of Pain Intensity Scores(NRS) From Baseline After 6 Weeks Treatment With the Study.|Change in numeric rating scales (NRS) such as score for average pain levels over the previous 24 hours, from baseline to 6weeks. NRS score was measured from 0 (No pain) to 10(worst pain imaginable).|6 weeks|ITT analysis set: 258||units on a scale||Standard Deviation|Mean
662888|NCT01813721|Secondary|Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology|During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of factors on a source document worksheet, and asked to rank the factors that they considered to be the most important when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. Subgroup analyses were performed where a subgroup contained at least 40 investigators. ECOG = Eastern Cooperative Oncology Group.|Assessed at baseline, prior to participant enrolment.|Primary analysis set - investigators; analysis only includes subgroups with at least 40 investigators.||percentage of investigators|Investigators|95% Confidence Interval|Number
662889|NCT01813721|Secondary|Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Clinical Specialty|During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of factors on a source document worksheet, and asked to rank the factors that they considered to be the most important when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group. Subgroup analyses were performed where a subgroup contained at least 40 investigators. Results are reported for medical oncologists as this was the only specialty that contained at least 40 investigators.|Assessed at baseline, prior to participant enrolment.|Primary analysis set - investigators; analysis only includes subgroups with at least 40 investigators.||percentage of investigators|Investigators|95% Confidence Interval|Number
662890|NCT01813721|Secondary|Percentage of Investigators Who Ranked Each Factor in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important|During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of factors on a source document worksheet, and asked to rank the factors that they considered to be the most important when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group.|Assessed at baseline, prior to participant enrolment.|Primary analysis set - investigators||percentage of investigators|Investigators|95% Confidence Interval|Number
662891|NCT01813721|Primary|Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important|Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment was collected in this study. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group.|At enrolment, prior to chemotherapy initiation.|Primary analysis set||percentage of participants||95% Confidence Interval|Number
662892|NCT01813721|Primary|Percentage of Participants for Whom Age and Chemotherapy Regimen Were Ranked as an Important Risk Factor|Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment were collected in this study. Age and chemotherapy regimen were specified in the protocol as risk factors of interest. Reported are age and chemotherapeutic agents ranked individually, chemotherapy agents detailed by specific factors, and age and chemotherapy agents jointly ranked. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.|At enrolment, prior to chemotherapy initiation|Primary analysis set which consists of all participants who satisfied the eligibility criteria and had at least one FN risk factor ranked by the investigator in their Subject Assessment.||percentage of participants||95% Confidence Interval|Number
662893|NCT01813721|Primary|Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia (FN)|During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of risk factors on a source document worksheet and asked to rank the risk factors that they considered to be the most important when assessing overall FN risk. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group|Assessed at Baseline, prior to participant enrolment.|Primary analysis set - investigators (PASI), which consists of investigators who contributed participants to the primary analysis set (PAS).||percentage of investigators|Investigators|95% Confidence Interval|Number
662894|NCT01813721|Primary|Percentage of Investigators Who Ranked Age and Chemotherapy Regimen as a Risk Factor for Febrile Neutropenia|During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of risk factors on a source document worksheet, and asked to rank the risk factors that they considered to be the most important when assessing overall febrile neutropenia (FN) risk. Age and chemotherapy regimen were specified in the protocol as risk factors of interest. Reported are age and chemotherapeutic agents ranked individually, chemotherapy agents detailed by specific factors, and age and chemotherapy agents jointly ranked. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.|Baseline (prior to participant enrolment)|Primary analysis set - investigators (PASI), which consists of investigators who contributed participants to the primary analysis set (PAS).||percentage of investigators|Investigators|95% Confidence Interval|Number
662895|NCT01813110|Secondary|Prostaglandin J3|Changes in plasma levels of prostaglandin J3 resulting from omega-3 supplementation and induced inflammation|7 days post endotoxin challenge||||||
662896|NCT01813110|Primary|Change in C Reactive Protein (CRP)|Change in blood levels of CRP at 24 hours post endotoxin administration, after each 8 week intervention|24 hours post endotoxin administration, following each 8 week intervention|||mg/L||Standard Error|Mean
662898|NCT01813019|Primary|Yale - Brown Obsessive Compulsive Scale (Y-BOCS) Absolute Change From Baseline at Week 17 (End of 16-week Dosing).|"The Y-BOCS is a 10 item clinician-rated scale used to both determine the severity of OCD and to monitor symptom improvement throughout the course of the study. The Y-BOCS, specifically measures the severity of symptoms of OCD without being biased towards the type of obsessions or compulsions present. The scale includes questions about the amount of time spent on, how much impairment or distress experienced from, and how much resistance and control over these obsessive thoughts and compulsions. Each item is rated from 0 (no symptoms) to 4 (extreme symptoms) and yields a total possible score range from 0 to 40, with the following ranges indicating degree of severity:
0–7 = sub-clinical 8–15 = mild 16–23 = moderate 24–31 = severe 32–40 = extreme Baseline was compared to week 17 (end of week 16 dosing) to produce an absolute change."|baseline, week 17|Pharmacodynamics (PD) analysis set only participants that were analyzed at baseline and Week 17. Positive change from baseline indicates a decrease in symptom severity||Scores on a scale||Standard Error|Least Squares Mean
662899|NCT01812837|Primary|Actinic Keratoses Reduction Percent||one month after treatment|||percentage||Standard Deviation|Mean
662900|NCT01812707|Secondary|Absolute Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 (ApoB/ApoA-1) Ratio at Week 12 - On-Treatment Analysis|Adjusted LS mean and standard errors were estimated using the same ANCOVA as for primary endpoint.|From Baseline to Week 12 (LOCF)|Participants of the mITT population with one baseline and at least one post baseline on-treatment value of ApoB/ApoA-1 ratio analyzed.||ratio||Standard Error|Least Squares Mean
662901|NCT01812707|Secondary|Percent Change From Baseline in Fasting Triglycerides and Lipoprotein (a) at Week 12 - On-Treatment Analysis|Since the assumptions of normal distribution and equality of variances were not verified for the lipid parameters, percent changes were expressed as median (inter-quartile range).|Baseline to Week 12 (LOCF)|Participants of the mITT population with one baseline and at least one post baseline on-treatment value of Fasting Triglycerides and Lipoprotein (a) analyzed.||percent change||Inter-Quartile Range|Median
662902|NCT01812707|Secondary|Percent Change From Baseline in Total Cholesterol, High-Density Lipoprotein Cholesterol (HDL-C), Non-HDL-C, and Apolipoprotein B (Apo-B) at Week 12 - On-Treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|Baseline to Week 12 (LOCF)|Participants of the mITT population with one baseline and at least one post baseline on-treatment value of lipid parameters analyzed.||percent change||Standard Error|Least Squares Mean
662903|NCT01812707|Secondary|Percentage of Participants Achieving Calculated LDL-C <100 mg/dL (2.59 mmol/L) and < 70 mg/dL (1.81 mmol/L) at Week 12 - On-Treatment Analysis||Week 12 (LOCF)|mITT population.||percentage of participants|||Number
662904|NCT01812707|Secondary|Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Week 12 - On-Treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|Baseline to Week 12 (LOCF)|mITT population.||mg/dL||Standard Error|Least Squares Mean
662905|NCT01812707|Secondary|Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Week 12 - On-Treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|Baseline to Week 12 (LOCF)|mITT population.||mmol/L||Standard Error|Least Squares Mean
662906|NCT01812707|Primary|Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis|Calculated LDL-C values were obtained using the Friedewald formula. Baseline adjusted least squares (LS) means and standard errors were estimated using an analysis of covariance (ANCOVA) model including available post-baseline data on treatment from first investigational product (IP) injection up to 21 days after last IP injection (on-treatment analysis). Missing Week 12 data were imputed by last observation carried forward [LOCF] method.|Baseline to Week 12 (LOCF)|Modified Intent-To-Treat (mITT) population included all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.||percent change||Standard Error|Least Squares Mean
662907|NCT01812681|Secondary|Sepsis|Association of vitamin D level with sepsis|four weeks|||participants|||Number
662908|NCT01812681|Primary|Respiratory Distress Syndrome|The association of vitamin D level with respiratory distress syndrome|three days|||participants|||Number
662909|NCT01812655|Secondary|Engagement With Distraction and Belief in Distraction's Efficacy|"For Engagement with Distraction,VR and PD participants were asked on the Post-testing Questionnaire: Were you able to pay attention to the DVD or to the VR during your burn treatment? (1=could not pay attention at all; 5=totally absorbed at all times)
For Belief in Distraction's Efficacy, VR and PD participants were asked on the Post-Procedure Questionnaire: I believe that the distraction lessened my pain during my burn treatment today. (on a scale of 1=Distraction did not help to lessen my pain at all; 5=Distraction completely helped to lessen my pain at all times)"|Post-procedure (approximately 30-75 minutes)|||scores on a scale||Standard Deviation|Mean
662910|NCT01812655|Secondary|Desire for Distraction|"Participants were asked I wanted to be distracted from during my treatment today. (Agree-Disagree) from the Post-Procedure Questionnaire"|Post-procedure (approximately 30-75 minutes)|||participants|||Number
662911|NCT01812655|Primary|Self-reported Wound Care Procedure Pain Score|The acute pain experienced during the burn wound care procedure was measured on a 100mm visual analog scale called the Adolescent Pediatric Pain Tool through self-report by adolescents ages 10-17 years receiving outpatient burn wound care. The scale ranges from 0mm (No Pain) to 100mm (Worst Pain).|Within the first 20 minutes following completion of the burn wound care procedure|Intention to treat||mm||95% Confidence Interval|Least Squares Mean
662912|NCT01812473|Primary|Differences in Overall Protein Binding in the Presence of Different Plasma Albumin Concentrations.|At steady state plasma concentrations of voriconazole, a plasma sample is taken to determine the overall protein binding of voriconazole. Equilibrium dialysis is used, followed by liquid chromatography-mass spectrometry.|At steady state plasma concentration of voriconazole (after day 4 of therapy)|||% of plasma protein binding|Participants|Inter-Quartile Range|Median
662913|NCT01812057|Secondary|Blood Pressure Measurements Obtained by the Standard of Care Non-invasive Blood Pressure Monitor Compared With the Continuous Noninvasive Arterial Pressure (CNAP)||Intraoperatively|No data was collected intraoperatively using CNAP on any participants.|||||
662914|NCT01812057|Secondary|Incidence of Wound Complications|Patients were assessed for signs of surgical wound inspection by the obstetric team following surgery|24 hours from PACU admission|||Participants|||Count of Participants
662915|NCT01812057|Secondary|Incidence of Post-operative Nausea and Vomiting (PONV) and Need for Rescue Antiemetics|"Patients who had experienced Postoperative nausea either reported postoperative nausea scores at 2, 24 and 48 hours from >0, reported an episode of vomiting or received an antiemetic were recorded as experiencing PONV.
Patients who received at least one rescue antiemetic postoperatively were recorded as requiring a rescue antiemetic"|2, 24 and 48 hours from PACU admission|||Participants|||Count of Participants
662916|NCT01812057|Secondary|Need for Intraoperative Analgesic Supplementation|Need for intraoperative analgesic supplementation was determined by patients who required intraoperative analgesics for pain|From spinal anesthesia placement to end of surgery, approximately 70 minutes|||Participants|||Count of Participants
662917|NCT01812057|Secondary|Incidence of Postoperative Pruritus|"Incidence of postoperative pruritus was calculated based on their postoperative pruritus scores measured at 2 hours, 24 hours and 48 hours. Median of the scores recorded at three time points was calculated.
If median score >0 then patient experienced postoperative pruritus."|48 hours from admission to PACU|||Participants|||Count of Participants
662918|NCT01812057|Secondary|Incidence of Intraoperative Pruritus|pruritus was defined as patients reporting a pruritus score of greater than o on a numerical rating scale with o=no pruritus and 10= worst pruritus|From spinal anesthesia placement to end of surgery, approximately 70 minutes|No data was collected on intraoperative pruritus on any participants.|||||
662919|NCT01812057|Secondary|Incidence of Intraoperative Nausea and Vomiting (IONV) and Need for Rescue Antiemetics.|Incidence of intraoperative nausea and vomiting and need for rescue antiemetics were recorded during surgery. Patient who reported a nausea score on a 11 point NRS where 0=no nausea and 10 = the worse nausea possible. Patients who retched or vomited were reported to have vomited. Patients receiving any antiemetic during surgery were recorded as those requesting ( needing) rescue antiemetic.|From spinal anesthesia placement to end of surgery, approximately 70 minutes|||Participants|||Count of Participants
662920|NCT01812057|Secondary|Pain Scores Between MTS Groups|Mechanical temporal summation (MTS) was assessed using A 180 g Von Frey Filament was applied to the volar aspect of the dominant forearm, and subjects were asked to rate pain scores (NRS 0-100, 0=no pain and 100=worst pain possible) after the 1st and 11th tap. A difference < 1 was recorded as MTS negative, and a difference > or = 1 was recorded as MTS positive.|24 hours after PACU admission|||units on a scale||Inter-Quartile Range|Median
662921|NCT01812057|Secondary|Incidence of Chronic Persistent Pain at 6 Months|Patients answered a questionnaire at 6 months to determine whether they still had persistent surgical site pain 6 months following surgery|6 months from the day of surgery|Analysis was based on available data from both arms including 25 patients. Data was missing for 11 patients in dexamethasone group and 11 patients in placebo group.||Participants|||Count of Participants
662922|NCT01812057|Secondary|Incidence of Chronic Persistent Pain at 8 Weeks|Patients answered a questionnaire at 8 weeks to determine whether they still had persistent surgical site pain 8 weeks following surgery|8 weeks from the day of surgery|Analysis was based on available data from both arms including 26 patients. Data was missing for 13 patients in dexamethasone group and 8 patients in placebo group.||Participants|||Count of Participants
662923|NCT01812057|Secondary|Cumulative Opioid Consumption at 24 Hours Between MTS Groups|Mechanical temporal summation (MTS) was assessed using A 180 g Von Frey Filament was applied to the volar aspect of the dominant forearm, and subjects were asked to rate pain scores (NRS 0-100, 0 = no pain and 100= worst pain possible) after the 1st and 11th tap. A difference < 1 was recorded as MTS negative, and a difference > or = 1 was recorded as MTS positive.|24 hours from admission to Postanesthesia care unit (PACU)|Analysis was based on all 47 patients who completed the study.||milligrams||Inter-Quartile Range|Median
662924|NCT01812057|Secondary|Pain Scores Between the Groups at 48 Hours.|Pain scores were measured using a numeric rating scale with a range from 0 to 10, with 0 meaning no pain and 10 indicating the most severe pain.|48 hours from PACU Admission|||units on a scale||Inter-Quartile Range|Mean
662925|NCT01812057|Secondary|Pain Scores Between the Groups at 24 Hours.|Pain scores were measured using a numeric rating scale with a range from 0 to 10, with 0 meaning no pain and 10 indicating the most severe pain.|24 hours from PACU admission|||units on a scale||Inter-Quartile Range|Median
662926|NCT01812057|Secondary|Cumulative Opioid Consumption at 48 Hours Between the Groups|The secondary outcome was the cumulative morphine consumption at 48 h in the two study groups. All postoperative opioids were converted to IV morphine equivalents using the following conversion factors: 100 micrograms IV = 10 mg IV morphine, 20 mg oxycodone po = 10 mg IV Morphine|Admission to PACU through 48 hours|||milligrams||Inter-Quartile Range|Median
662927|NCT01812057|Secondary|Time to Administration of First Rescue Analgesic Request Between the Groups.|Time in minutes from admission to PACU to the first request by the patient for oral oxycodone (analgesia) administration for pain|PACU admission to discharge from PACU an average of 2 hours|Analysis was based on all 47 patients who completed the study.||minutes||Inter-Quartile Range|Median
662928|NCT01812057|Secondary|Pain Scores Between the Groups at 2 Hours.|Pain scores were measured using a numeric rating scale with a range from 0 to 10, with 0 meaning no pain and 10 indicating the most severe pain.|2 hours from admission to postanesthesia care unit (PACU)|||units on a scale||Inter-Quartile Range|Median
662929|NCT01812057|Primary|Morphine Consumption at 24 Hours Post-op|The primary outcome will be the cumulative morphine consumption at 24 h in the two study groups. All postoperative opioids were converted to IV morphine equivalents using the following conversion factors: 100 micrograms IV = 10 mg IV morphine, 20 mg oxycodone po = 10 mg IV Morphine|24 hours from admission to Postanesthesia care unit (PACU)|||milligram||Inter-Quartile Range|Median
662930|NCT01812044|Secondary|Peak Pain Score During First 30 Minutes|"This secondary outcome will include the peak pain score for duration of follow up period. Pain will be assessed by masked observers, using the CHEOPS scale. The CHEOPS (Children's Hospital of Eastern Ontario Pain Scale) is a behavioral scale for evaluating postoperative pain in young children. The scale is assessed using the sum of a score for cry (1-3), facial expression (0-2), verbalization (0-2), torso (1-2), touch (1-2) and legs (1-2). The minimum score is 4, the maximum score is 13, and higher scores indicate more pain.
Pain is rated every 5 minutes for the first 30 minutes postoperatively."|0-30 minutes post-operative|||units on a scale||Standard Deviation|Mean
662931|NCT01812044|Secondary|Number of Participants Who Required Anti-emetic Medication Post-operatively||Total time in post-operative recovery - up to 6 hours|||participants|||Number
662932|NCT01812044|Secondary|Number of Participants With Post Operative Nausea and Vomiting||0-150 minutes post-operative|||participants|||Number
662934|NCT01812044|Secondary|Negative Postoperative Behavior Score on the PHBQ (Post Hospitalization Behavioral Questionnaire)|"This secondary outcome will determine the negative postoperative behaviors based on the PHBQ questionnaire given to the parents of the child 1 week (+/- 3 days) post-operatively.
with a score of 81 indicating no change, a score of less than 81 indicating a change for the better, and a score of over 81 indicating a change for the worse, on average, in behavior.
Lowest score 27; highest score 135"|1 week (+/- 3 days) post operatively|||units on a scale||Standard Deviation|Mean
662935|NCT01812044|Secondary|Total Narcotic Use During Post-operative Recovery|This secondary outcome will include total narcotic use|Total time in post-operative recovery - up to 6 hours|||mcg/kg||Standard Deviation|Mean
662936|NCT01812044|Secondary|Peak Pain Score|"This secondary outcome will include the peak pain score for duration of follow up period. Pain will be assessed by masked observers, using the CHEOPS scale. The CHEOPS (Children's Hospital of Eastern Ontario Pain Scale) is a behavioral scale for evaluating postoperative pain in young children. The scale is assessed using the sum of a score for cry (1-3), facial expression (0-2), verbalization (0-2), torso (1-2), touch (1-2) and legs (1-2). The minimum score is 4, the maximum score is 13, and higher scores indicate more pain.
A pain score was assessed and recorded every 5 minutes by a masked observer (clinical research coordinator) for the first 30 minutes after extubation, then every 15 minutes for the next hour, then, if applicable, hourly until discharge."|0-150 minutes post-operative|||units on a scale||Standard Deviation|Mean
662937|NCT01812044|Primary|Average Pain Score Over the First 30 Post-operative Minutes Using the CHEOPS Scale|"Pain will be assessed by a masked observer using the Children's Hospital Eastern Ontario Pain Scale (CHEOPS) scale. The CHEOPS (Children's Hospital of Eastern Ontario Pain Scale) is a behavioral scale for evaluating postoperative pain in young children. The scale is assessed using the sum of a score for cry (1-3), facial expression (0-2), verbalization (0-2), torso (1-2), touch (1-2) and legs (1-2). The minimum score is 4, the maximum score is 13, and higher scores indicate more pain.
Pain is rated every 5 minutes for the first 30 minutes postoperatively. Each pain score collected in the first 30 minutes was averaged to calculate a per per participant average pain score over the first 30 minutes . Then each participant's per participant average pain score was combined to calculate the reported mean for “Average pain score over the first 30 post-operative minutes using the CHEOPS scale.” for each group."|0-30 minutes post-operative|||units on a scale||Standard Deviation|Mean
662938|NCT01811953|Secondary|Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point, Metformin|AUC0-tz: area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point for Metformin|1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|PKS: included all subjects of the TS who provided at least one observation for at least one primary PK endpoint and who did not have a protocol violation relevant to the evaluation of Pharmacokinetics.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
662939|NCT01811953|Primary|Maximum Measured Concentration of the Analyte in Plasma, Metformin|Cmax: maximum measured concentration of the analyte in plasma for Metformin|1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|PKS: included all subjects of the TS who provided at least one observation for at least one primary PK endpoint and who did not have a protocol violation relevant to the evaluation of Pharmacokinetics.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
662940|NCT01811953|Primary|Maximum Measured Concentration of the Analyte in Plasma, Empagliflozin|Cmax: maximum measured concentration of the analyte in plasma for Empagliflozin|1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|PKS: included all subjects of the TS who provided at least one observation for at least one primary PK endpoint and who did not have a protocol violation relevant to the evaluation of Pharmacokinetics.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
662941|NCT01811953|Secondary|Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point, Empagliflozin|AUC0-tz: area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point for Empagliflozin|1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|PKS: included all subjects of the TS who provided at least one observation for at least one primary PK endpoint and who did not have a protocol violation relevant to the evaluation of Pharmacokinetics.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
662942|NCT01811953|Primary|Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity, Metformin|AUC0-inf: area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity for Metformin|1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|PKS: included all subjects of the TS who provided at least one observation for at least one primary PK endpoint and who did not have a protocol violation relevant to the evaluation of Pharmacokinetics.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
662943|NCT01811953|Primary|Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity, Empagliflozin|AUC0-inf: area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity for Empagliflozin|1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|Pharmacokinetic set (PKS): included all subjects of the TS who provided at least one observation for at least one primary PK endpoint and who did not have a protocol violation relevant to the evaluation of Pharmacokinetics.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
663000|NCT01811186|Secondary|The Drop-out Rate Due to an Adverse Event After 1 Week Treatment With the Study Drug.|The drop-out rate due to an adverse event after treatment (1 week) by treatment arm were summarized and presented as frequency and percentage, and the inter-group difference were compared by using a Chi-square test or Fisher’s exact test.|1 week|Intent to treat analysis set: 258(Last observation Carried Forward)||percentage of participants|||Number
662944|NCT01811732|Secondary|Investigator Assessment at the Late Follow-up Visit|"A patient was considered a Cure if all baseline signs and symptoms of ABSSSI had resolved; if some symptoms remained, but the patient was improved to the extent that no additional antibiotic treatment was necessary, the response was Improved. A patient was considered a Failure for any of the following reasons: nonstudy antibacterial drug therapy was required because of lack of efficacy after at least 4 doses of study drug or for a treatment-related AE; study antibacterial drug therapy was required for longer than 28 doses; and/or unplanned surgical intervention was needed after study entry except for limited bedside debridement and standard wound care. Improved and Indeterminate responses were considered failures in the primary analysis.
A sensitivity analysis was also performed, in which the assigned responses were Success (Cure + Improved) or Failure (Failure + Indeterminate/Missing)."|Study Day 21 to 28|ITT Population||Participants|||Count of Participants
662945|NCT01811732|Secondary|Investigator Assessment at the Follow-up Visit (EMA Primary Endpoint)|"A patient was considered a Cure if all baseline signs and symptoms of ABSSSI had resolved; if some symptoms remained, but the patient was improved to the extent that no additional antibiotic treatment was necessary, the response was Improved. A patient was considered a Failure for any of the following reasons: nonstudy antibacterial drug therapy was required because of lack of efficacy after at least 4 doses of study drug or for a treatment-related AE; study antibacterial drug therapy was required for longer than 28 doses; and/or unplanned surgical intervention was needed after study entry except for limited bedside debridement and standard wound care. Improved and Indeterminate responses were considered failures in the primary analysis.
A sensitivity analysis was also performed, in which the assigned responses were Success (Cure + Improved) or Failure (Failure + Indeterminate/Missing)."|Study Day 14 +/- 1 day|ITT Population||Participants|||Count of Participants
662946|NCT01811732|Primary|Objective Response at 48 to 72 Hours (FDA Primary Endpoint)|A patient was considered a responder if s/he had a ≥20% reduction in size of the area of erythema associated with the baseline ABSSSI, as determined by digital planimetry of the leading edge and had none of the reasons for clinical failure; a patient was considered a non-responder (failure) if s/he had <20% reduction in size of the area of erythema associated with the baseline ABSSSI as determined by digital planimetry of the leading edge, or had major intervention such as another antibiotic or surgical intervention or died within 74 hours after initiation of study drug.|48 to 72 hours after starting treatment|ITT Population||Participants|||Count of Participants
662947|NCT01811706|Secondary|Biomechanical Assessment of Gait (BAG)-Stride Length|Biomechanical Assessment of Gait is a sensitive, quantitative movement analysis system. Stride length was analyzed. Baseline values are recorded twice. One was at the beginning of the intervention. The second was 2 weeks after washout period and before the second intervention.|Baseline and 4 weeks after Dalfampridine or placebo|||cm||Standard Deviation|Mean
662948|NCT01811706|Secondary|Change in Scale of Assessment and Rating of Ataxia (SARA)|Scale for the assessment and rating of ataxia (SARA) is a clinical scale that is based on a semiquantitative assessment of cerebellar ataxia on an impairment level. SARA has 8 items that are related to gait, stance, sitting, speech, finger-chase test, nose-finger test, fast alternating movements and heel-shin test. SARA score ranges from 0 to 40, with higher scores indicating more severe disease.|Baseline and 4 weeks after Dalfampridine or placebo|||point||Standard Deviation|Mean
662949|NCT01811706|Primary|Change in Timed 25 Feet Walking Test (T25FW)|The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The time, in seconds, is calculated from the initiation of the instruction to start and ends when the patient has reached the 25-foot mark. Baseline values are recorded twice. One was at the beginning of the intervention. The second was 2 weeks after washout period and before the second intervention.|Baseline and 4 weeks after Dalfampridine or placebo|Patient with spinocerebellar ataxia (SCA) 1, 2, 3, or 6||second||Standard Deviation|Mean
662950|NCT01811680|Primary|10 Meter Walk Test|Assess time taken to walk 10meters to estimate walking speed(m/s) (Assessed at weeks 0,2,4,8)|8 weeks|||m/s||Standard Deviation|Mean
662951|NCT01811680|Primary|6 Minute Walk Test (Metres)|6 minute walk test - assess distance walked within 6 minutes as a sub maximal test of endurance (Assessed at weeks 0,2,4 and 8)|8 weeks|chronic stroke||metres||Standard Deviation|Mean
662952|NCT01811563|Other Pre-specified|Timed Get up and go|The timed up and go requires a patient to rise from a chair walk three meters around a piece of tape and return to the chair again as quickly as possible.|Baseline (Pre-Operative), 6 weeks and 52 weeks following total knee replacement|The 6 week time point was not used in the final analysis based on the clinical decision that 6 weeks was too early in recovery to provide accurate information for clinical decision making. Subjects used in the final analysis were those subjects who completed the assessment at pre-op and 1 year post-op (20 subjects per arm).||Seconds||Standard Deviation|Mean
662953|NCT01811563|Other Pre-specified|Sit to Stand Time|The sit to stand test requires patients to stand up and sit down as many times as possible in 10 seconds from a standard arm chair.|Baseline (Pre-Operative), 6 weeks and 52 weeks following total knee replacement|The 6 week time point was not used in the final analysis based on the clinical decision that 6 weeks was too early in recovery to provide accurate information for clinical decision making. Subjects used in the final analysis were those subjects who completed the assessment at pre-op and 1 year post-op (20 subjects per arm).||Number of times||Standard Deviation|Mean
662954|NCT01811563|Other Pre-specified|Knee Society Score (KSS)|The KSS is a patient reported measure of knee function that is specific to patients who are scheduled to receive or have previously had a total knee replacement. This outcome measures both patient reported pain and function changes from prior to surgery through recovery. The score range is from 0 to 100. The highest score of 100 points will be obtained by a well-aligned knee with no pain, 125 degrees of motion, and negligible anteroposterior and mediolateral instability.|Baseline (Pre-Operative), 6 weeks and 52 weeks following total knee replacement|Only 20 subjects in each arm completed the assessment at 1 year post-op.||units on a scale||Standard Deviation|Mean
663001|NCT01811186|Primary|Drop-out Rate Caused by Adverse Event After 6 Weeks Treatment|To assess the drop-out rate caused by adverse event* after 6 weeks treatment|6 weeks|Intent to treat analysis set: 258 patients (Last Observation Carried Forward)||percentage of participants|||Number
663002|NCT01810952|Post-Hoc|Percent of Glucose Determinations >180 mg/dL||1-5 days|||Percent of glucose values|||Number
663003|NCT01810952|Secondary|Glucose Values <70 mg/dL.|# participants with glucose values <70 mg/dL|1-5 days|||participants|||Number
662955|NCT01811563|Other Pre-specified|Change in Forgotten Joint Score (FJS) From 6 Weeks to 52 Weeks Following Total Knee Replacement.|"The FJS is a patient reported measure of how bothersome the total joint replacement is for them, how much it affects daily activity and how much they are aware of the implant. The FJS is a 12-question survey regarding functional outcome, pain, stability, daily living, activity and sport. Scoring is from 0 to 4 with 0 as the best outcome; a low score means high satisfaction. Not all questions must be answered to score, all responses are summed and the total is divided by number of completed items multiplied by 25, with the final result subtracted from 100. The score range is from 0 to 100 with the highest score of 100 indicating the best outcome (the joint is completely forgotten) and 0 indicating the worst outcome."|6 weeks and 52 weeks following total knee replacement|Participants who completed the Forgotten Joint Score (FJS) at week 6 and week 52. Not all subjects completed the FJS.||units on a scale||Standard Deviation|Mean
662956|NCT01811563|Other Pre-specified|Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) Total From Baseline to 52 Weeks Following Total Knee Replacement.|The KOOS is a standardized and validated patient outcome score that assesses functional limitation in patient with knee problems. KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.|Baseline (Pre-Operative) and 52 weeks following total knee replacement|Subjects used in the final analysis were those subjects who completed the assessment at pre-op and 1 year post-op (20 subjects per arm).||units on a scale||Standard Deviation|Mean
662957|NCT01811563|Other Pre-specified|University of California, Los Angeles (UCLA) Activity Score at 6 Weeks Following Total Knee Replacement.|"The UCLA activity score is a validated patient reported outcome of overall physical activity. Results on a scale of 1 to 10, 1 is Wholly Inactive, dependent on others, and can not leave residence and 10 is Regularly participates in impact sports."|6 weeks following total knee replacement|Only subjects who were able to complete the UCLA at six weeks were included in the analysis.||units on a scale||Standard Deviation|Mean
662958|NCT01811563|Other Pre-specified|Change in University of California, Los Angeles (UCLA) Activity Score From Baseline to 52 Weeks Following Total Knee Replacement.|"The UCLA activity score is a validated patient reported outcome of overall physical activity. Results on a scale of 1 to 10, 1 is Wholly Inactive, dependent on others, and can not leave residence and 10 is Regularly participates in impact sports."|Baseline and 52 weeks following total knee replacement|Subjects used in the final analysis were those subjects who completed the assessment at pre-op and 1 year post-op (20 subjects per arm).||units on a scale||Standard Deviation|Mean
662959|NCT01811563|Secondary|Walking Speed at 6 Weeks Following Total Knee Replacement.|Each subject will complete three walking trials at a self-selected comfortable walking speed along a 5 meter walkway in order to record walking speed at each time point.|6 weeks following total knee replacement|||miles per hour||Standard Deviation|Mean
662960|NCT01811563|Secondary|Change in Walking Speed From Baseline to 52 Weeks Following Total Knee Replacement.|Each subject will complete three walking trials at a self-selected comfortable walking speed along a 5 meter walkway in order to record walking speed at each time point.|Baseline and 52 weeks following total knee replacement|||miles per hour||Standard Deviation|Mean
662961|NCT01811563|Primary|Change in Lower Quarter Y-Balance Test (YBT-LQ) (Dynamic Balance) From Baseline to 52 Weeks Following Total Knee Replacement|The lower quarter y-balance test (YBT-LQ) is a test of dynamic balance in unilateral stance that has been deemed to be reliable and valid. The YBT-LQ consists of each patient standing on one leg and reaching as far as they can with their non-stance leg in the anterior, posteromedial and posterolateral direction while standing on the other foot on a centralized stance platform. The composite score is calculated as the sum of the three reach directions divided by 3 time the limb length and will be reported as a percentage of limb length.|Baseline (Pre-Operative) to 52 weeks following total knee replacement|Subjects used in the final analysis were those subjects who completed the assessment at pre-op and 1 year post-op (20 subjects per arm).||% of limb length||Standard Deviation|Mean
662962|NCT01811563|Primary|Change in Lower Quarter Y-Balance Test (YBT-LQ) (Dynamic Balance) From Baseline to 6 Weeks Following Total Knee Replacement|The lower quarter y-balance test (YBT-LQ) is a test of dynamic balance in unilateral stance that has been deemed to be reliable and valid. The YBT-LQ consists of each patient standing on one leg and reaching as far as they can with their non-stance leg in the anterior, posteromedial and posterolateral direction while standing on the other foot on a centralized stance platform. The composite score is calculated as the sum of the three reach directions divided by 3 time the limb length and will be reported as a percentage of limb length.|Baseline (Pre-Operative) to 6 weeks following total knee replacement|Only subjects that were able to complete all of the YBT assessments at 6 weeks post total knee replacement were included in the analyses.||% of limb length||Standard Deviation|Mean
662963|NCT01811485|Secondary|Number of Patients With Adverse Events (Including Hypoglycemia), Serious Adverse Events and Death|The occurrence of adverse events were sought by non-directive questioning of the patient at each visit. Adverse events are defined as appearance or worsening of any undesirable symptom, sign (including an abnormal laboratory finding), or medical conditions. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.|14 weeks|Safety set (SAF): consists of all patients who received at least one dose of study medication.||Patients|||Number
662964|NCT01811485|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at 14 Weeks|FPG was performed on a blood sample obtained and analyzed at a central laboratory.|Baseline to 14 weeks|FAS consisted of all randomized patients who received at least one dose of study medication and had at least one post-randomization efficacy parameter measurement.||mg/dL||Standard Error|Least Squares Mean
663004|NCT01810952|Secondary|Daily Insulin Dose/Kg Body Weight|Total daily dose of insulin required based on weight and glucocorticoid dosage to achieve average daily finger stick glucose (FSG) levels of 90-140 mg/dL|1-5 days|||units of insulin/Kg body weight||Standard Deviation|Mean
663005|NCT01810952|Secondary|Percent of Participants With Average Glucose >70 and <180 mg/dL|Percent of Participants with Average Daily Glucose >70 and <180 mg/dL|Last Full Day of Protocol for Participant (up to Day 5)|||percentage of participants|||Number
662965|NCT01811485|Secondary|Percentage of Patients Meeting Responder Rates in HbA1c|"Responder rate was analyzed in categories: 1. Endpoint HbA1c ≤ 6.5% 2. Endpoint HbA1c < 7% 3. Endpoint HbA1c < 7% in patients with baseline HbA1c ≤ 8% 4. Endpoint HbA1c < 6.9% 5. HbA1c reduction from baseline at endpoint ≥ 1% 6. HbA1c reduction from baseline at endpoint ≥ 0.5%.
Categories 1, 2, and 4 - 'n' includes only patients with baseline HbA1c > 6.5%, ≥ 7%, ≥ 6.9% and endpoint HbA1c measurement. Category 3, 'n' includes only patients with 7% ≤ baseline HbA1c ≤ 8% and endpoint HbA1c. Category 5 and 6, 'n' indicates number of patients with both baseline and endpoint HbA1c measurements."|Baseline, 14 weeks|The full analysis set (FAS) consisted of all randomized patients who received at least one dose of study medication and had at least one post-randomization efficacy parameter measurement.||Percentage of patients|||Number
662966|NCT01811485|Secondary|Change From Baseline in HbA1c at 14 Weeks Within LMF237 Treatment Groups|HbA1c will be performed on a blood sample obtained and measured by HPLC. HPCL was performed at a central laboratory.|Baseline to 14 weeks|Full analysis set consisted of all randomized patients who received at least one dose of study medication and had at least one post-randomization efficacy parameter measurement.||percentage of glycosylated haemoglobin||Standard Error|Least Squares Mean
662967|NCT01811485|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 14 Weeks Between Treatment Groups|HbA1c was performed on a blood sample obtained and measured by High performance liquid chromatography (HPLC). HPCL was performed at a central laboratory.|Baseline to 14 weeks|Full analysis set consisted of all randomized patients who received at least one dose of study medication and had at least one post-randomization efficacy parameter measurement.||percentage of glycosylated haemoglobin||Standard Error|Least Squares Mean
662968|NCT01811472|Secondary|Number of Patients With Adverse Events, Serious Adverse Events (SAEs) and Death as Assessment of Safety and Tolerability||24 weeks|Safety set (SAF) - All patients who received at least one dose of study drug and had at least 1 post-baseline safety assessment.||Patients|||Number
662969|NCT01811472|Secondary|Change From Baseline in Waist Circumference||Baseline, 12 and 24 weeks|Full analysis set included all patients to whom study treatment was assigned excluding patients who were miss-randomized and did not take investigational drug. Patients with both baseline and post-baseline values at different timepoints were included in this endpoint analysis||centimeter (cm)||90% Confidence Interval|Least Squares Mean
662970|NCT01811472|Secondary|Change From Baseline in Body Weight||Baseline, 12 and 24 weeks|Full analysis set included all patients to whom study treatment was assigned excluding patients who were miss-randomized and did not take investigational drug. Patients with both baseline and post-baseline values at different timepoints were included in this endpoint analysis||kilogram (kg)||90% Confidence Interval|Least Squares Mean
662971|NCT01811472|Secondary|Post-prandial Peak Triglycerides Over 0 - 8 Hours|"Post-prandial peak triglycerides is reported as maximum triglyceride value over 0-8 hours.
Adjusted geometric means which is reported are calculated by back-transforming the adjusted means from the model. Baseline is defined as the value collected at Week 0 (randomization)."|Baseline, 6 and 24 weeks|Full analysis set included all patients to whom study treatment was assigned excluding patients who were miss-randomized and did not take investigational drug. Patients with non-missing values at different timepoints were included in this endpoint analysis||mg/dL||90% Confidence Interval|Geometric Mean
662972|NCT01811472|Secondary|Percent Change From Baseline in Fasting Triglycerides|"Blood samples were collected for a fasting triglycerides (TG) after a 10-hour (overnight) fast.
Adjusted geometric means which is reported are calculated by back-transforming the adjusted means from the model and expressing as a percentage change from baseline. Baseline is defined as the value collected at Week 0 (randomization)."|Baseline, 6, 12 and 24 weeks|Full analysis set included all patients to whom study treatment was assigned excluding patients who were miss-randomized and did not take investigational drug. Patients with non-missing values at different timepoints were included in this endpoint analysis||percent change||90% Confidence Interval|Geometric Mean
662973|NCT01811472|Secondary|Percentage of Patients With Normalized Liver Enzymes|Normalized liver enzymes defined as alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 40 U/L. Normal/High categories at baseline are defined by criteria of normal. Better is defined as high' at baseline and 'normal' post-dose; Same is defined as 'normal' at baseline and 'normal' post-dose or 'high' at baseline and 'high' post-dose; Worse is defined as 'normal' at baseline and 'high' post-dose.|Baseline, week 6, week 12 and week 24|Full analysis set included all patients to whom study treatment was assigned excluding patients who were miss-randomized and did not take investigational drug. Patients with non-missing liver enzyme values at different timepoints were included in this endpoint analysis.||Percentage of patients|||Number
662974|NCT01811472|Secondary|Change From Baseline Values for Alanine Aminotransferase (ALT) , Aspartate Aminotransferase (AST) and Gamma-glutamyl Transpeptidase (GGT) to Week 24|"Change from baseline ALT, AST and GGT values collected post-dose was analyzed using Mixed Model of Repeated Measurements (MMRM). Baseline is defined as the value collected at Week 0 (randomization).
Treatment group and visit were fitted as factors and baseline was fitted as a continuous covariate."|From Baseline to week 24|Full analysis set included all patients to whom study treatment was assigned excluding patients who were miss-randomized and did not take investigational drug. Patients with non-missing liver enzyme values at week 24 were included in this endpoint analysis.||U/L||90% Confidence Interval|Least Squares Mean
662975|NCT01811472|Secondary|Change From Baseline Values for Alanine Aminotransferase (ALT) , Aspartate Aminotransferase (AST) and Gamma-glutamyl Transpeptidase (GGT) to Week 12|"Change from baseline ALT, AST and GGT values collected post-dose was analyzed using Mixed Model of Repeated Measurements (MMRM). Baseline is defined as the value collected at Week 0 (randomization).
Treatment group and visit were fitted as factors and baseline was fitted as a continuous covariate."|From Baseline to week 12|Full analysis set included all patients to whom study treatment was assigned excluding patients who were miss-randomized and did not take investigational drug. Patients with non-missing liver enzyme values at week 12 were included in this endpoint analysis.||U/L||90% Confidence Interval|Least Squares Mean
663006|NCT01810952|Primary|Average Daily Glucose Levels on Days 1-5 After the Initiation of the Treatment Protocol.|"Most patients had 4 and all patients had at least 2 readings each day. Average daily glucose values were determined for each participant, then averaged for each Arm."|1-5 days|We used t-tests to compare values between the protocols on each day..||mg/dL||Standard Deviation|Mean
663984|NCT01792830|Secondary|Incidence Rates for Post-operative Complications|Number of complications including infections, wound infections, readmissions|3 months after discharge||||||
662976|NCT01811472|Secondary|Change From Baseline Values for Alanine Aminotransferase (ALT) , Aspartate Aminotransferase (AST) and Gamma-glutamyl Transpeptidase (GGT) to Week 6|"Change from baseline ALT, AST and GGT values collected post-dose was analyzed using Mixed Model of Repeated Measurements (MMRM). Baseline is defined as the value collected at Week 0 (randomization).
Treatment group and visit were fitted as factors and baseline was fitted as a continuous covariate."|From Baseline to week 6|Full analysis set included all patients to whom study treatment was assigned excluding patients who were miss-randomized and did not take investigational drug. Patients with non-missing liver enzyme values at different timepoint were included in this endpoint analysis.||U/L||90% Confidence Interval|Least Squares Mean
662977|NCT01811472|Secondary|Percentage of Responders at Week 24|"The response criteria are defined as:
a. A reduction of ≥ 30% from baseline in liver fat b. A reduction of ≥ 50% from baseline in liver fat c. Liver fat content < 10% d. Liver fat content < 5.6%. Percentage is calculated as (m/n)*100 where m: number of patients who are responders. n: number of patients with non-missing percent liver fat at that visit."|From baseline to week 24|Full analysis set included all patients to whom study treatment was assigned excluding patients who were miss-randomized and did not take investigational drug. Patients with non-missing percent liver fat at week 24 were included in this endpoint analysis.||Percentage of responders|||Number
662978|NCT01811472|Secondary|Percentage of Responders at Week 12|"The response criteria are defined as:
a. A reduction of ≥ 30% from baseline in liver fat b. A reduction of ≥ 50% from baseline in liver fat c. Liver fat content < 10% d. Liver fat content < 5.6%. Percentage is calculated as (m/n)*100 where m: number of patients who are responders. n: number of patients with non-missing percent liver fat at that visit."|At week 12|Full analysis set included all patients to whom study treatment was assigned excluding patients who were miss-randomized and did not take investigational drug. Patients with non-missing percent liver fat at week 12 were included in this endpoint analysis.||Percentage of responders|||Number
662979|NCT01811472|Secondary|Change From Baseline in Percentage of Fat in the Liver as Assessed Using MRI at Week 12|Patients were to undergo MRI three times during the course of the study to assess liver fat. Baseline is defined as the value collected at Week -2 MRI assessment (approximately between Day -7 to -14).|From baseline to week 12|Full analysis set included all patients to whom study treatment was assigned excluding patients who were miss-randomized and did not take investigational drug. Patients with baseline and post-baseline value at week 12 are included in this analysis.||Percentage of liver fat||90% Confidence Interval|Least Squares Mean
662980|NCT01811472|Primary|Change From Baseline in Percentage of Fat in the Liver as Assessed Using MRI at Week 24|Patients were to undergo MRI three times during the course of the study to assess liver fat. Baseline is defined as the value collected at Week -2 MRI assessment (approximately between Day -7 to -14).|From baseline to week 24|Full analysis set included all patients to whom study treatment was assigned excluding patients who were miss-randomized and did not take investigational drug. Patients with baseline and post-baseline value at week 24 are included in this analysis.||Percentage of liver fat||95% Confidence Interval|Least Squares Mean
662981|NCT01811355|Primary|Cramp Severity|Daily cramp severity was rated on the 100-unit visual analog scale. Scores ranged from 0 to 100, with 100 being the greatest amount of cramp severity|6 weeks|Among the 21 patients who completed the study, 1 patient did not return the outcome diary, which resulted in 20 patients available for analysis.||units on a scale||Standard Deviation|Mean
662982|NCT01811355|Primary|Daily Muscle Cramps|The average of the daily recording of number of muscle cramps that occurred in the last 24 hours- over a 6 week period.|6 weeks|Among the 21 patients who completed the study, 1 patient did not return the outcome diary, which resulted in 20 patients available for analysis.||Cramps per 24 hours||Standard Deviation|Mean
662988|NCT01811303|Secondary|Maximum Blood Glucose Concentration (C Max) Over the Baseline|"Determine the glucose C max of Sucrose with D-fagomine over the baseline.
The blood glucose maximum concentration (C-Max) expressed in mmol/L of the average response for a 50g sucrose, over the baseline.
Calculation of the outcome is= (Measure glucose C-Max - Measure glucose baseline)"|Usually in the range of 30-45 minutes|||mmol/L||Standard Error|Mean
662989|NCT01811303|Primary|Postprandial Glycaemic Response Index|On each intervention, the volunteer measured a baseline fasting blood sugar measurement for that day and repeated this approximately 5 minutes later so that two fasting measurements were obtained under the supervision of staff. All of the subsequent measurements were assessed against the average of the two baseline readings. Each subject was then presented with a test product and they were instructed to consume the whole amount within a fifteen-minute period. Each volunteer then took a blood sugar readings at 15, 30, 45, 60, 90 and 120 minutes following the initiation of consumption of the test product. Measurements were taken using the Ascensia Contour, Blood Glucose Monitoring Systems (Bayer), which analysed the blood sample and provided a blood glucose reading in mmol/l. The AUC is calculated using the trapezoid rule and the final outcome is the incremental area under the curve for the arm expressed as a percent of the average response for the control by the same subject.|120 minutes|The number of participants >10, the repetitions >= 2 and also other variables was determined based on F. Brouns et al., Glycaemic index methodology,Nutrition Research Reviews (2005), 18, 145–171. Also was considered the advice and previous GI studies from RSSL based on master protocol GIMST09.||percentage of AUC fagomine/AUC control||95% Confidence Interval|Mean
662990|NCT01811238|Secondary|Patient Global Impression of Change(PGIC)|Number of participants with categorical change in overall satisfaction. PGIC: a participant-rated instrument assessing change in participant's overall satisfaction from baseline, on a scale ranging from 1 (very much improved) to 7 (very much worse).|Baseline, 8week|IIT set, Missing values were imputed by LOCF.||participants|||Number
662991|NCT01811238|Secondary|Change From Baseline in Health-related Quality of Life Assessed by EuroQol Visual Analog Scale (EQ-5D VAS)|The EQ VAS records the respondent’s self-rated health on a vertical, visual analogue scale where the endpoints are labelled ‘Best imaginable health state’ (score = 100) and ‘Worst imaginable health state’ (score = 0). Higher points were positive results and positive points of difference gap means improvement results.|Baseline, 8 weeks|ITT set, Missing values were imputed by LOCF. Difference (Visti 4(8w)-Baseline)||scores on a scale||Standard Deviation|Mean
662992|NCT01811238|Secondary|Change of Pain Intensity in Patient With Spinal Disorder at Week 4 of Treatment With the Study Drug From Baseline|"NRS-Pain scale assessed the severity of a subject's pain of mean pain over the past 24 hours prior to the visit on a scale of 0 (No pain) and 10 (Worst possible pain).
Change = mean score at Week 4/ET minus mean score at Baseline."|Baseline, 4 week|IIT set.||units on a scale||Standard Deviation|Mean
662993|NCT01811238|Secondary|Clinical Global Impression of Change(CGIC)|"The number of patients who choose the best opinion of overall satisfaction among Clinical Global Impression of Change Scale(CGIC) among 7 point scale. Missing data was imputed by LOCF.
Very much improved much improved minimally improved no change minimally worse much worse very much worse"|Baseline, 8 week|ITT Population. Below results : Visit 4(8week)(LOCF): n(%)||participants|||Number
662994|NCT01811238|Secondary|The Change in Quality of Life (EQ-5D) at Week 8 of Treatment With the Study Drug From Baseline|"EQ-5D to measure of health related quality of life should be answered as one of 3 levels about current condition for 5 dimensions and was calculated total average by giving a weighting on 3 level of answers (EQ-5D levels into 'no problems' (level 1) and 'problems' (level 2 and 3)).
Table of scores by each level for EQ-5D items: mobility(level 1=0, level2=0.069,level 3=0.314), self care(level 1=0, level2=0.104,level 3=0.214), usual activities(level 1=0, level2=0.036,level 3=0.094), pain/discomfort (level 1=0, level2=0.,level 3=0.386) and anxiety/depression(level 1=0, level2=0.071,level 3=0.2)
*EQ-5D Total = 1 - 0.081 - (the score of the each level) - 0.269 (if at least one of level 3 presents)
EQ-5D total score could be 0.919 in maximum and -0.594 in minimum if case all index indicates the level 3. So, if EQ-5D total score closed by “1” means that the healthy condition and high quality of life."|Baseline, 8 week|ITT set included all subjects who participated in the study and had at least one dose of the study drug and had at least one primary efficacy endpoint data available.Missing values were imputed by LOCF.||scores on a scale||Standard Deviation|Mean
662995|NCT01811238|Primary|Change From Baseline in Pain Intensity of Patient With Spinal Disorder as Measured by NRS.|"NRS-Pain scale assessed the severity of a subject's pain of mean pain over the past 24 hours prior to the visit on a scale of 0 (No pain) and 10 (Worst possible pain).
Change = mean score at Week 8/ET minus mean score at Baseline."|Baseline, 8 week|"The 209 is IIT set population. ITT set included all subjects who participated in the study and had at least one dose of the study drug and had at least one primary efficacy endpoint data available.
Missing values were imputed by LOCF."||scores on a scale||Standard Deviation|Mean
662996|NCT01811186|Secondary|Assessment of Subject’s Overall Satisfaction After 6 Weeks Treatment With the Study Drug|At each visit, the subject assessed the overall satisfaction for efficacy by using the 7 point scale of Patient Global Impression of Change Scale(PGIC).|6weeks|ITT analysis set: 171. Last visit(Visit 5) data was handled as LOCF. However, Missing Number as visit 3 for assessment of Investigator’s overall satisfaction after 6 weeks treatment with the study drug was Group A = 50, Group B=37.||participants|||Number
662997|NCT01811186|Secondary|Assessment of Investigator’s Overall Satisfaction After 6 Weeks Treatment With the Study Drug|Investigator’s overall satisfaction after treatment (6 weeks) (Clinical Global Impression of Change Scale(CGIC) 7 point scale) by treatment arm were summarized and presented as frequency and proportion, and the inter-group difference were compared by using a Chi-square test or Fisher’s exact test.|6 weeks|ITT analysis set: 171. Last visit(Visit 5) data was handled as LOCF. However, Missing Number as visit 3 for assessment of Investigator’s overall satisfaction after 6 weeks treatment with the study drug was Group A = 50, Group B=37.||participants|||Number
662998|NCT01811186|Secondary|Change of Quality of Life (EQ-5D) Score After 6 Weeks Treatment With the Study Drug|"EQ-5D to measure of health related quality of life should be answered as one of 3 levels about current condition for 5 dimensions and was calculated total average by giving a weighting on 3 level of answers (EQ-5D levels into 'no problems' (level 1) and 'problems' (level 2 and 3)).
Table of scores by each level for EQ-5D items: mobility(level 1=0, level2=0.069,level 3=0.314), self care(level 1=0, level2=0.104,level 3=0.214), usual activities(level 1=0, level2=0.036,level 3=0.094), pain/discomfort (level 1=0, level2=0.,level 3=0.386) and anxiety/depression(level 1=0, level2=0.071,level 3=0.2)
*EQ-5D Total = 1 - 0.081 - (the score of the each level) - 0.269 (if at least one of level 3 presents)
EQ-5D total score could be 0.919 in maximum and -0.594 in minimum if case all index indicates the level 3. So, if EQ-5D total score closed by 1 means that the healthy condition and high quality of life."|6 weeks|ITT analysis set.||units on a scale||Standard Deviation|Mean
663007|NCT01810939|Primary|Change in Serum Potassium From Part B Baseline|"Change in Serum Potassium from Part B Baseline to either:
Part B Week 4 visit, if the participant’s serum potassium remained ≥ 3.8 mEq/L and < 5.5 mEq/L up to the Part B Week 4 visit or the earliest Part B visit at which the participant’s serum potassium was < 3.8 mEq/L or ≥ 5.5 mEq/L."|Part B Baseline to Part B Week 4 or first local laboratory serum potassium < 3.8 mEq/L or ≥ 5.5 mEq/L|||mEq/L||Inter-Quartile Range|Median
663008|NCT01810939|Primary|Change in Serum Potassium From Part A Baseline to Part A Week 4|The primary analysis endpoint is the change from Baseline at Week 4. The estimate of the change at Week 4 is from a repeated measures model, which includes data from Weeks 1, 2, 3 and 4. The analysis includes all intent to treat participants who had a serum potassium result at baseline and at least one weekly post-baseline visit (i.e. Part A Week 1 or later) and excludes six participants who had no result collected after Day 3).|Part A Baseline to Part A Week 4|||mEq/L||Standard Error|Least Squares Mean
663009|NCT01810939|Secondary|Proportion of Participants With Serum Potassium ≥ 5.1 mEq/L in Part B||Part B Baseline to Part B Week 8|Percentages were estimated not as simple ratios, but by using a stratified method, in order to account for differences between the patiromer and placebo groups in terms of whether participants had type 2 diabetes mellitus and whether they entered the study with serum potassium < 5.8 mEq/L or serum potassium ≥ 5.8 mEq/L.||percentage of participants|||Number
663010|NCT01810939|Secondary|Proportion of Participants With Serum Potassium That Was ≥ 5.5 mEq/L in Part B||Part B Baseline to Part B Week 8|||percentage of participants|||Number
663011|NCT01810939|Secondary|Proportion of Participants With Serum Potassium Levels in the Target Range of 3.8 to < 5.1 mEq/L at Part A Week 4||Week 4|Proportion of participants with serum potassium level in the target range at Part A Week 4||percentage of participants||95% Confidence Interval|Number
663012|NCT01810783|Primary|Safety and Tolerability|Number of treatment-emergent adverse events (TEAEs)|Up to 52 weeks and a safety follow-up by telephone contact or clinic visit after 30 days after the last dose of investigational medicinal product (IMP)|210 patients were enrolled, only 209 patients were treated with brexpiprazole.TAES is based on these 209 patients||TEAEs|||Number
663013|NCT01810692|Secondary|Overall Satisfaction Question|The overall satisfaction ranges from 1=very dissatisfied to 7=very satisfied.|day 1|Patients from FAS||units on a scale||Standard Deviation|Mean
663014|NCT01810692|Secondary|Total Convenience PASAPQ Score|All questions were answered on a 7-point scale ranging from 1= very dissatisfied to 7 = very satisfied).To calculate the domain scores, the sum of the items of the convenience domain was transformed to a 0- (least) to 100- (most) point scale which is scaled positively:higher scores represent higher levels of satisfaction.|day 1|Patients from FAS.||units on a scale||Standard Deviation|Mean
663015|NCT01810692|Secondary|Total Performance PASAPQ Score.|All questions were answered on a 7-point scale ranging from 1= very dissatisfied to 7 = very satisfied).To calculate the domain scores, the sum of the items of the performance domain was transformed to a 0- (least) to 100- (most) point scale which is scaled positively:higher scores represent higher levels of satisfaction.|day 1|Patients from FAS.||units on a scale||Standard Deviation|Mean
663016|NCT01810692|Primary|Total Mean Score of the Validated Patient Satisfaction and Preference Questionnaire (PASAPQ)|Patient satisfaction with regard to the total score of the handling of the inhaled devices performed by means of a PASAPQ. All questions were answered on a 7-point scale ranging from 1= very dissatisfied to 7 = very satisfied).To calculate the total score, the sum of the 13 items of the two domains (performance and convenience) was transformed to a 0- (least) to 100- (most) point scale which is scaled positively:higher scores represent higher levels of satisfaction.|day 1|Patients from the Full Analysis Set (FAS) which includes all patients from TS who provide evaluable data for the total score of the PASAPQ.||units on a scale||Standard Deviation|Mean
663017|NCT01810666|Secondary|Difference of Intra-individual Change of Joint Function During Each Period Assessed by the Hemophilia Joint Health Score Between On-demand and Prophylaxis Period|Hemophilia Joint Health Score(HJHS) ranges from 0 to 124. Higher values in the HJHS represent worse situation for the subject. 2-sided Hodges Lehmann estimates for median 95% CI HJHS values difference of changes ITT analysis set.|From baseline to Week 12 (on-demand treatment) and Week 24 (prophylactic treatment)|||Scores on scale||95% Confidence Interval|Median
663018|NCT01810666|Secondary|Difference of Annualized Number of Joint Bleeds Between On-demand and Prophylaxis Period|Annualized joint bleedings period 1 minus period 2 ITT analysis set.|Week 1-12 (on-demand treatment) and 13-24 (prophylactic treatment)|||Bleeds||95% Confidence Interval|Median
663019|NCT01810666|Primary|Difference of Annualized Number of All Bleeds Between On-demand and Prophylaxis Period|Annualized bleedings period 1 minus period 2 ITT analysis set.|Week 1-12 (on-demand treatment) and 13-24 (prophylactic treatment)|||Bleeds||95% Confidence Interval|Median
663020|NCT01810380|Secondary|PSP Domain D: Disturbing and Aggressive Behaviours at Week 6|PSP domain D: disturbing and aggressive behaviours were categorised as “aggressive” (corresponding to mild, manifest, marked, severe, or very severe) or “nonaggressive” (corresponding to absent)|Week 6|FAS. As this was based on observed cases, only patients who have PSP assessment at Week 6 were included in this analysis; the number of participants analysed is therefore smaller than the defined FAS and also smaller than other PSP analyses where last assessment carried forward was used.||percentage of aggressive patients|||Number
663021|NCT01810380|Secondary|PSP Functional Response Rate at Week 6|The PSP functional response rate was defined as ≥10 point improvement from Baseline on the PSP total score|Week 6|FAS (last assessment). Patients who have no post-baseline PSP values available were not included as response is defined based on change from baseline and no baseline carried forward analysis was planned; the number of participants analysed is therefore smaller than the defined FAS.||percentage of responders|||Number
663022|NCT01810380|Secondary|PSP Functional Remission Rate at Week 6|The PSP functional remission rate was defined as a PSP total score ≥71|Week 6|FAS (last assessment). Patients who have no post-baseline PSP values available were not included as response is defined based on change from baseline and no baseline carried forward analysis was planned; the number of participants analysed is therefore smaller than the defined FAS.||percentage of remitters|||Number
663056|NCT01809834|Secondary|Investigator's Objective Assessment of Anterior Ocular Physiological Response, Conjunctiva (Biomicroscopy)|Investigators assigned an anterior ocular physiological response grade by biomicroscopy assessment with conjuncitval staining (grading scale, 0-4, 0=none, 4=severe) Change over time measured at baseline (screening and dispensing visit), 12-hours, 1-week|Baseline, 12-hours, 1-week|||units on a scale|Participants|Standard Deviation|Mean
663023|NCT01810380|Secondary|Change From Baseline to Week 6 in PSP Total Score|The Personal and Social Performance Scale (PSP) is a clinician-rated scale designed and validated to measure a patient’s current level of social functioning. The PSP scale consists of a 100-point single-item rating scale, subdivided into 10 equal intervals. Scores of 1 to 10 indicate lack of autonomy in basic functioning, whereas scores of 91 to 100 reflect excellent functioning. The total score is rated by the investigator and is based on an algorithm which takes both the ratings of the 4 primary domains of PSP, and the combination of these ratings into account. The 4 primary domains are: socially useful activities (including work and study), personal and social relationships, self-care, and disturbing and aggressive behaviours. The 4 domains are assessed on a 6-point scale, from absent to very severe. A higher score indicates a better performance.|Baseline and Week 6|FAS. PSP was collected at Baseline, Day 21 and Day 42 only, due to the windowing only patients with PSP assessments between Days 15 to 27 and after Day 35 were included in this analysis; the number of participants analysed is therefore smaller than the defined FAS and also smaller than other PSP analyses using LOCF.||units on a scale||Standard Error|Mean
663024|NCT01810380|Secondary|Response Rate at Week 6|The response rate was defined as a reduction of ≥30% from baseline in PANSS total score OR a CGI-I score of 1 or 2|Baseline and Week 6|FAS (last assessment)||percentage of responders|||Number
663025|NCT01810380|Secondary|Discontinuation Due to Lack of Efficacy During the Study|Discontinuation due to lack of efficacy was based on the primary reason for withdrawal|Baseline to Week 6|APTS||percentage of patients|||Number
663026|NCT01810380|Secondary|Change From Baseline to Week 6 in PANSS Marder Factor Scores: Anxiety/Depression|The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Marder Factor scores: anxiety/depression is calculated from 4 items (for example: anxiety, guilt feelings, and tension). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms|Baseline and Week 6|FAS||units on a scale||Standard Error|Mean
663027|NCT01810380|Secondary|Change From Baseline to Week 6 in PANSS Marder Factor Scores: Uncontrolled Hostility/Excitement|The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Marder Factor scores: uncontrolled hostility/excitement is calculated from 4 items (for example: excitement, hostility, and uncooperativeness).Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms|Baseline and Week 6|FAS||units on a scale||Standard Error|Mean
663028|NCT01810380|Secondary|Change From Baseline to Week 6 in PANSS Marder Factor Scores: Disorganized Thoughts|The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Marder Factor scores: disorganized thoughts is calculated from 7 items (for example: conceptual disorganization, difficulty in abstract thinking and mannerisms and posturing). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms|Baseline and Week 6|FAS||units on a scale||Standard Error|Mean
663029|NCT01810380|Secondary|Change From Baseline to Week 6 in PANSS Marder Factor Scores: Positive Symptoms|The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Marder Factor scores: positive symptoms is calculated from 8 items (for example: delusions, conceptual disorganization and stereotype thinking). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms|Baseline and Week 6|FAS||units on a scale||Standard Error|Mean
663030|NCT01810380|Secondary|Change From Baseline to Week 6 in PANSS Marder Factor Scores: Negative Symptoms|The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Marder Factor scores: negative symptoms is calculated from 7 items (for example: blunted affect, emotional withdrawal and motor retardation). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms|Baseline and Week 6|FAS||units on a scale||Standard Error|Mean
663031|NCT01810380|Secondary|Change From Baseline to Week 6 in PANSS Excited Component Score|The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Excited Component score is calculated from 5 items (for example: poor impulse control, tension and hostility). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms|Baseline and Week 6|FAS||units on a scale||Standard Error|Mean
663032|NCT01810380|Secondary|Change From Baseline to Week 6 in PANSS General Psychopathology Subscale Score|The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS General Psychopathology Subscale score is calculated from 16 items (for example: somatic concern, anxiety and guilt feelings). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms|Baseline and Week 6|FAS||units on a scale||Standard Error|Mean
663033|NCT01810380|Secondary|Change From Baseline to Week 6 in PANSS Negative Subscale Score|The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Negative Subscale score is calculated from 7 items (for example: blunted affect, emotional withdrawal and poor rapport). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms|Baseline and Week 6|FAS||units on a scale||Standard Error|Mean
663985|NCT01792830|Secondary|Hypoglycemic Events|Number of subjects that experienced hypoglycemia, defined as blood glucose levels ≤70 mg/dl|3 months after discharge||||||
663034|NCT01810380|Secondary|Change From Baseline to Week 6 in PANSS Positive Subscale Score|The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Positive Subscale score is calculated from 7 items (for example: delusions, conceptual disorganization and hallucinatory behaviour). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms|Baseline and Week 6|FAS||units on a scale||Standard Error|Mean
663035|NCT01810380|Secondary|CGI-I Score at Week 6|"The Clinical Global Impression – Global Improvement (CGI-I) provides the clinician’s impression of the patient’s improvement (or worsening).
The clinician assesses the patient’s condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). In all cases, the assessment should be made independent of whether the rater believes the improvement is drug-related or not."|Week 6|FAS||units on a scale||Standard Error|Mean
663036|NCT01810380|Secondary|Change From Baseline to Week 6 in CGI-S Score|"The Clinical Global Impression – Severity of Illness (CGI-S) provides the clinician’s impression of the patient’s current state of mental illness.
The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients)."|Baseline and Week 6|FAS||units on a scale||Standard Error|Mean
663037|NCT01810380|Primary|Change From Baseline to Week 6 in PANSS Total Score|The Positive and Negative Syndrome Scale (PANSS) is a 30-item scale for assessing the symptoms of schizophrenia. For each PANSS item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score (30 items) ranged from 30 to 210 with a higher score indicating greater severity of symptoms.|Baseline and Week 6|Full-analysis set (FAS)||units on a scale||Standard Error|Mean
663038|NCT01810302|Secondary|Number of Participants With Cerebral Vasospasm.||Day 1 of study drug until post-hemorrhage day 10.|Number of participants were not sufficient to perform data analysis.|||||
663039|NCT01810302|Primary|Number of Participants With Bacterial Meningitis.||Day 1 of study drug until post-hemorrhage day 10.|Number of participants were not sufficient to perform data analysis.|||||
663040|NCT01810289|Secondary|Evaluate the Effect of START on the Incidence of Vertical Transmission in All HIV-infected Women Who Are Treatment-eligible During the Study Period.||3 years||||||
663041|NCT01810289|Secondary|Evaluate the Effect of START on HIV RNA Levels Among Treatment-eligible, HIV-infected Patients||3 years||||||
663042|NCT01810289|Secondary|Evaluate the Effect of START on Retention in HIV Care Among Treatment-eligible, HIV-infected Patients.||3 years||||||
663043|NCT01810289|Secondary|Evaluate the Effect of START on the Incidence of Mortality in Treatment-eligible, HIV-infected Patients.||3 years||||||
663044|NCT01810289|Primary|Evaluate Programmatic Change of START on Cumulative Incidence of ART Initiation 14 Days After Clinical Eligibility in Treatment Eligible HIV-infected Patients||3 years|||participants|||Number
663045|NCT01810263|Other Pre-specified|Subjective Global Assessment||6 months||||||
663046|NCT01810263|Other Pre-specified|Triceps Skin Fold Thickness||6 months||||||
663047|NCT01810263|Other Pre-specified|Body Mass Index||6 months||||||
663048|NCT01810263|Secondary|Chemical Laboratory Findings||6 months||||||
663049|NCT01810263|Primary|Modified Barthel Index (MBI) Score at 6 Months|Scale range: 0-100 (higher values represent a better outcome)|6 months|||units on a scale||Standard Deviation|Mean
663050|NCT01810042|Secondary|Visual Acuity Changes|"Visual acuity is measured at baseline and 6 months using ETDRS chart. The changes was calculated by visual acuity at 6 months minus visual acuity at baseline.
Positive values represent improvement of visual acuity, and negative values represent worsening of visual acuity at 6 months compared to baseline."|baseline and 6 months|Among 39 patients who completed the study, 8 patients were excluded because of poor ICGA quality or presence of polypoidal choroidal vasculopathy.||ETDRS letters||Full Range|Median
663051|NCT01810042|Secondary|Visual Acuity in ETDRS Letters|Visual acuity was assessed using the ETDRS chart. The ETDRS chart includes 100 letters as the maximum possible score, and 0 letters read as the minimum possible score. Higher scores represents better functioning.|6 months|Among 39 patients who completed the study, 8 patients were excluded because of poor ICGA quality or presence of polypoidal choroidal vasculopathy.||ETDRS letters||Full Range|Median
663052|NCT01810042|Secondary|Lesion Size of CNV|Lesion size of CNV is measured in fluorescein angiography using software, and find correlation with caliber of choroidal new vessels.|6 months|Among 39 patients who completed the study, 8 patients were excluded because of poor ICGA quality or presence of polypoidal choroidal vasculopathy.||square milimeter||Full Range|Mean
663053|NCT01810042|Primary|Caliber of Choroidal New Vessel (CNV)|Caliber of the largest CNV is measured using a software of IVAN (developed by Wisconsin University) that measures a caliber of retinal vessels using a semi-automatic method. An indocyanine green angiography (ICGA) image showing the vascular structures of CNV was processed to invert black and white for the analysis. The image was loaded in the software, and the course of the arteriolar CNV was indicated manually. Then average thickness of the vascular segment was calculated.|6 months|Of 31 patients included in the baseline analysis, 7 patients had the thickest vessels under limitation of measurement.||micrometer||Full Range|Mean
663054|NCT01809938|Secondary|T½|"T½ = time from baseline to the time the cross-sectional surface area (CSA) of the gastric antrum, measured using realtime ultrasound, returned to half the maximal value (CSA½max ). CSA ½ max calculated as below:
CSA½max = CSAmax - [(CSAmax - CSAbaseline)/2]"|Measurments taken every 10 minutes for 1 hour and then 30 minute intervals until 150 minutes had elapsed. Each participant spent approximately 3 hours for each arm of the trial separated by no less than 24 hours.|It was difficult to visualise under ultrasound the gastric antrum in one patient after they drank both black tea and tea with milk, so they were exlcuded from final analysis of the US data only.||minutes||95% Confidence Interval|Geometric Mean
663055|NCT01809938|Primary|Tmax|tmax = the time taken to reach peak paracetamol concentration. The blood samples were analysed for the level of paracetamol, from which the time taken to reach peak paracetamol concentration was subsequently calculated. Blood samples were taken at the same time points as the ultrasound measurements.|Blood samples taken every 10 minutes for 1 hour and then 30 minute intervals until 150 minutes had elapsed. Each participant spent approximately 3 hours for each arm of the trial separated by no less than 24 hours|||minutes||Standard Deviation|Mean
663058|NCT01809834|Secondary|Investigator's Objective Assessment of Visual Acuity, High Contrast at Low Illumination (Snellen)|"Investigators tested participants using snellen charts distant to the participant in each eye (monocular) at low lighting conditions (low illumination).
(logMAR, 0.00 = 20/20 Snellen acuity, positive values = poorer visual acuity, negative values = better visual acuity). Change over time measured at insertion, 12-hours, 1-week."|Insertion, 12-hours, 1-week|||logMAR|Participants|Standard Deviation|Log Mean
663059|NCT01809834|Secondary|Investigator's Objective Assessment of Visual Acuity, High Contrast at High Illumination (Snellen)|"Investigators tested participants using snellen charts distant to the participant in each eye (monocular) at normal lighting conditions (high illumination).
(logMAR, 0.00 = 20/20 Snellen acuity, positive values = poorer visual acuity, negative values = better visual acuity). Change over time measured at insertion, 12-hours, 1-week."|Insertion|||logMAR|Participants|Standard Deviation|Log Mean
663060|NCT01809834|Primary|Participant's Subjective Rating of Overall Preference (Questionnaire)|Participants rated their overall lens preference by questionnaire. (annotated scale, 0-100, scale normalized to 0=no preference, +50=strongly prefers test lens, -50=strongly prefers control lens). Change over time measured at 12-hours, 1-week|12-hours, 1-week|||score on a scale||Standard Deviation|Mean
663061|NCT01809834|Primary|Participant's Subjective Rating of Visual Quality (Questionnaire)|Participants rated visual quality of the lenses by questionnaire (annotated scale, 0-100, 0=extremely poor vision all of the time. Cannot function, 100=excellent vision all of the time) Change over time measured at 12-hours, 1-week|12-hours, 1-week|||units on a scale|Participants|Standard Deviation|Mean
663062|NCT01809834|Primary|Participant's Subjective Rating of Lens Handling for Removal (Questionnaire)|Participants rated their lens handling experience for the lens removal by questionnaire (un-annotated scale, 0-100, 0=could not remove lens from eye, 100=always easy to remove lens from eye) Change over time measured at 12-hours, 1-week|12-hours, 1-week|One participant temporarily discontinued from study after 12-hour visit. (n=43 at 1-week visit)||units on a scale|Participants|Standard Deviation|Mean
663063|NCT01809834|Primary|Participant's Subjective Rating of Lens Handling for Insertion (Questionnaire)|Participants rated their lens handling experience for lens insertion by questionnaire (un-annotated scale, 0-100, 0=could not place lens on eye, 100=always easy to place lens on eye) Measured at Dispensing|Dispense|||score on a scale|Participants|Standard Deviation|Mean
663064|NCT01809834|Primary|Participant's Subjective Rating of Dryness (Questionnaire)|Participants rated dryness of the lenses by subjective questionnaire (annotated scale, 0-100, 0=cannot be worn / extremely dry, 100=no dryness experienced at any time) Change over time measured at 12-hours, 1-week|12-hours, 1-week|||units on a scale|Participants|Standard Deviation|Mean
663065|NCT01809834|Secondary|Investigator's Objective Assessment of Overall Fit Acceptance (Biomicroscopy)|"Investigators assigned an overall fit acceptance grade by biomicroscopy assessment (grading scale, 0-4, 0=very poor, 4=very good).
Change over time measured at insertion, 12-hours, 1-week"|Insertion, 12 hours, 1 week|||units on a scale|Participants|Standard Deviation|Mean
663066|NCT01809834|Secondary|Investigator's Objective Assessment of Lens Surface Wettability (Biomicroscopy)|"Investigators assigned a lens surface wettability grade by biomicroscopy assessment (grading scale, 0 to 4, 0=excellent, 4=severely reduced).
Change over time measured after lens settling (insertion), after 12-hours wear on the dispense day (12-hours), after a minimum on one hour of lens wear at 1 week (1-week)."|Insertion, 12 hours, 1 week|||units on a scale|Participants|Standard Deviation|Mean
663067|NCT01809834|Primary|Participant's Subjective Rating of Comfort (Questionnaire)|Participants rated their comfort of lenses by subjective questionnaire (un-annotated scale, 0-100, 0=Poor comfort/intolerable, 100=Excellent comfort/cannot be felt) Change over time measured at insertion, After settling, 12-hours, 1-week|Insertion, After Lens settling, 12-hours, 1-week|One participant temporarily discontinued from study after 12-hour visit. (n=43 at 1-week visit)||units on a scale|Participants|Standard Deviation|Mean
663068|NCT01809639|Primary|Time (in Days) That a Patient Reports Symptoms From Their Concussion.|The total time that a patient reports symptoms will be assessed. Once the patient reports that they are asymptomatic, the patient will repeat the Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) test to determine if the patient's score has returned to baseline.|From date of injury until date asymptomatic, assessed up to 24 months|||Days Symptomatic||Standard Error|Mean
663069|NCT01809327|Secondary|Number of Participants With Treatment Emergent Adverse Events (AEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study drug and up to 30 days after last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state.|Up to 30 weeks of last study drug administration|Safety Analysis Set included all randomized participants who received at least 1 dose of double-blind study drug.||participants|||Number
663070|NCT01809327|Secondary|Percent Change in Triglycerides From Baseline to Week 26|The percentage change in triglycerides from baseline to Week 26 was compared between the different treatment groups.|Day 1 (Baseline) and Week 26|"Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Here N (Number of Participants Analyzed) signifies number of Participants who were evaluable for this outcome measure."||percent change||Standard Deviation|Mean
663071|NCT01809327|Secondary|Percent Change in Fasting High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26|The percentage change in Fasting High-Density Lipoprotein Cholesterol (HDL-C) from baseline to Week 26 was compared between the different treatment groups.|Day 1 (Baseline) and Week 26|"Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Here N (Number of Participants Analyzed) signifies number of Participants who were evaluable for this outcome measure."||percent change||Standard Error|Least Squares Mean
663072|NCT01809327|Secondary|Change in Systolic Blood Pressure From Baseline at Week 26|The change in systolic blood pressure from baseline at Week 26 was compared between the different treatment groups.|Day 1 (Baseline) and Week 26|"This analysis was conducted using the modified intent-to-treat analysis set, which included all participants who were randomly assigned to a treatment group and received at least 1 dose of study drug. Here N (Number of Participants Analyzed) signifies number of Participants who were evaluable for this outcome measure."||millimeter of mercury (mm Hg)||Standard Error|Least Squares Mean
663073|NCT01809327|Secondary|Percentage of Participants With Glycated Hemoglobin (HbAIc) Less Than 7 Percent at Week 26|The percentage of participants achieved HbAIc less than 7 percent at Week 26 was compared between the different treatment groups.|Week 26|"This analysis was conducted using the modified intent-to-treat analysis set, which included all participants who were randomly assigned to a treatment group and received at least 1 dose of study drug. Here N (Number of Participants Analyzed) signifies number of Participants who were evaluable for this outcome measure."||percentage of participants|||Number
663074|NCT01809327|Secondary|Percent Change in Body Weight From Baseline to Week 26|The percentage change in body weight from baseline to Week 26 was compared between the different treatment groups.|Day 1 (Baseline) and Week 26|"This analysis was conducted using the modified intent-to-treat analysis set, which included all participants who were randomly assigned to a treatment group and received at least 1 dose of study drug. Here N (Number of Participants Analyzed) signifies number of Participants who were evaluable for this outcome measure."||percent change||Standard Error|Least Squares Mean
663075|NCT01809327|Primary|Change in Glycated Hemoglobin (HbA1c) From Baseline at Week 26|The change in the value of glycated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) from baseline at Week 26 was compared between the different treatment groups.|Day 1 (Baseline) and Week 26|"This analysis was conducted using the modified intent-to-treat analysis set, which included all participants who were randomly assigned to a treatment group and received at least 1 dose of study drug. Here N (Number of Participants Analyzed) signifies number of Participants who were evaluable for this outcome measure."||percentage of hemoglobin||Standard Error|Least Squares Mean
663076|NCT01809314|Secondary|Percentage of Participants Who Required Blood Transfusions During the Study|The percentage of participants who required blood transfusions was reported at each assessment visit and was based on the 1-month period preceding the respective visit.|Baseline to Month 1, Month 1 to 2, Month 2 to 3, Month 3 to 4|"All Participants Enrolled. The Number of Participants Analyzed reflects the total combined number of participants who provided data for the endpoint. The number of participants who provided data for the analysis at each timepoint (n) is shown in the table."||percentage of participants|||Number
663077|NCT01809314|Secondary|Percentage of Participants by Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to EOT|"ECOG performance status was determined at Baseline and at the EOT visit at Month 4. The assessment used a 3-point scale, including scores of 0 (fully active/able to carry on all pre-disease activities without restriction), 1 (restricted in physically strenuous activity but ambulatory/able to carry out light or sedentary work), or 2 (ambulatory for more than 50% of waking hours and capable of all self care but unable to carry out any work activities). The traditional 6-point scale was not valid because only participants with a performance status of 0, 1, or 2 were eligible for the study. The percentage of participants by change in ECOG performance status was reported. For example, the percentage of participants with ECOG performance status of 0 at Baseline and 2 at EOT is shown in the table as Baseline 0, EOT 2. Transition to a lower performance status indicates improved/increased independence."|Baseline, Month 4|"All Participants Enrolled; only those who provided data at all study visits were included in the analysis. The Number of Participants Analyzed reflects the total combined number of participants who provided data for the endpoint. The number of participants used in the denominator for each calculation (n) was based on the ECOG status at Baseline."||percentage of participants|||Number
663078|NCT01809314|Primary|Change in Hemoglobin (Hb) Level From Baseline to End of Treatment (EOT)|The change in Hb level from Baseline to the EOT visit at Month 4 was averaged among all participants and expressed in grams per liter (g/L).|Baseline, Month 4|All Participants Enrolled; only those who provided data at all study visits were included in the analysis.||g/L||95% Confidence Interval|Mean
663079|NCT01809262|Secondary|Laboratory Testing: Average Change From Baseline of Potassium and Calcium|Laboratory testing: Average change from baseline of potassium and calcium measured on test-days|Baseline and Visit 6|Safety set.||mmol/L||Inter-Quartile Range|Geometric Mean
663080|NCT01809262|Secondary|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG|Clinical relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsenings of baseline conditions were reported as Adverse Events (cardiac disorders and investigations).|2 weeks|Safety set||percentage of participants|||Number
663081|NCT01809262|Secondary|Number of Patients Requiring Rescue Medication on a Test-day|Number of Patients Requiring Rescue Medication on a Test-day. Salbutamol inhalation aerosol MDI (Ventolin®, 100 μg/actuation) was provided for use as rescue medication. Administration of rescue medication can occur at any point during the pulmonary function testing as deemed necessary by the patient or the investigator.|Visits 1,2,4,5,6|Safety set which consisted of all randomised patients who had taken at least one dose of study medication.||Number of Patients|||Number
663082|NCT01809262|Secondary|Time to Onset of Response|Onset of the bronchodilator response after a single dose of study treatment was defined as the linear interpolation of the time of the first bronchodilator response and the time of the observation just prior to the first bronchodilator response (even if that is the baseline observation). If none of the FEV1 values in the first 3 hours after dosing exceeded 12% of the pre-dose value, then the onset was set to 3 hours plus 1 minute.|0 to 3 hours post-dosing|Full Analysis Set (FAS): The FAS consisted of all treatment periods with baseline data and post-dosing data available for this endpoint.||minutes||Standard Deviation|Mean
663083|NCT01809262|Secondary|Time to Peak Bronchodilator Response|A bronchodilator response was considered to have been achieved if an FEV1 measurement of at least 12% greater than the test-day baseline value was recorded at any time during the first 3 hours of observation after dosing.|0 to 3 hours post-dosing|Full Analysis Set (FAS): The FAS consisted of all treatment periods with baseline data and post-dosing data available for this endpoint.||minutes||Standard Deviation|Mean
663084|NCT01809262|Secondary|Peak Forced Vital Capacity (FVC) From 0 to 3 Hours|Peak FVC was defined as the maximum values of FVC from 0 to 3 hours.|0 to 3 hours post-dosing|Full Analysis Set (FAS): The FAS consisted of all treatment periods with baseline data and post-dosing data available for this endpoint||L||Standard Error|Mean
663085|NCT01809262|Secondary|Peak FEV1 From 0 to 3 Hours|Peak FEV1 was defined as the maximum values of FEV1 from 0 to 3 hours.|0 to 3 hours post-dosing|Full Analysis Set (FAS): The FAS consisted of all treatment periods with baseline data and post-dosing data available for this endpoint||L||Standard Error|Mean
663086|NCT01809262|Secondary|FEV1 AUC 12 - 24 Hours|The FEV1 AUC was calculated as the area under the curve above zero as the horizontal axis from 12 hours to 24 hours, using the trapezoidal rule divided by 12 hours to give the results in litres. The test-day baseline (defined as the pulmonary function test (PFT) at 10 minutes before inhalation of study medication) was assigned to time zero.|12h, 14h, 22h, 23h and 24h post-dosing|Full Analysis Set (FAS): The FAS consisted of all treatment periods with baseline data and post-dosing data available for this endpoint||L||Standard Error|Mean
663087|NCT01809262|Secondary|FEV1 AUC 0 - 24 Hours|The FEV1 AUC was calculated as the area under the curve above zero as the horizontal axis from zero time to 24 hours, using the trapezoidal rule divided by 24 hours to give the results in litres. The test-day baseline (defined as the pulmonary function test (PFT) at 10 minutes before inhalation of study medication) was assigned to time zero.|-10 minutes (min), 30min, 1 hour (h), 2h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 22h, 23h and 24h post-dosing|Full Analysis Set (FAS): The FAS consisted of all treatment periods with baseline data and post-dosing data available for this endpoint||L||Standard Error|Mean
663088|NCT01809262|Secondary|FEV1 AUC 0 - 12 Hours|The FEV1 AUC was calculated as the area under the curve above zero as the horizontal axis from zero time to 12 hours, using the trapezoidal rule divided by 12 hours to give the results in litres. The test-day baseline (defined as the pulmonary function test (PFT) at 10 minutes before inhalation of study medication) was assigned to time zero.|-10 minutes (min), 30min, 1 hour (h), 2h, 3h, 4h, 6h, 8h, 10h and 12h post-dosing|Full Analysis Set (FAS): The FAS consisted of all treatment periods with baseline data and post-dosing data available for this endpoint||L||Standard Error|Mean
663089|NCT01809262|Secondary|FEV1 AUC 0 - 3 Hours|The FEV1 AUC was calculated as the area under the curve above zero as the horizontal axis from zero time to 3 hours, using the trapezoidal rule divided by 3 hours to give the results in litres. The test-day baseline (defined as the pulmonary function test (PFT) at 10 minutes before inhalation of study medication) was assigned to time zero.|-10 minutes (min), 30min, 1 hour (h), 2h and 3h post-dosing|Full Analysis Set (FAS): The FAS consisted of all treatment periods with baseline data and post-dosing data available for this endpoint||L||Standard Error|Mean
663090|NCT01809262|Primary|Forced Expiratory Volume in One Second (FEV1) at 24 Hours After a Single-dose of Study Treatment|Forced expiratory volume in one second (FEV1) at 24 hours after a single-dose of study treatment. Means are adjusted with test-day baseline, patient, treatment, and period as fixed effects. Test-day baseline value was defined as the value at 10 minutes before inhalation of study medication.|24 hours post-dosing|Full Analysis Set (FAS): The FAS consisted of all treatment periods with baseline data and post-dosing data for FEV1 at 24 hours.||L||Standard Error|Mean
663091|NCT01809197|Primary|"Likert Scale Questionnaire Item: I Can Comfortably Wear my Lenses"|Response of subject to a questionnaire item using a 5-point Likert scale, where 5=strongly agree and 1=strongly disagree.|Day 30; after 4 hours of lens wear|This analysis population includes all subjects who were randomized and received study regimen (test or control) with a Day 30 response to this Likert item.||units on a scale||Standard Deviation|Least Squares Mean
663092|NCT01809106|Other Pre-specified|The Opioid Escalation Index|The proportion of subjects with an increase of opioid daily dose > 5% compared with the basal dosage (OEI%).|28 days|||participants|||Number
663093|NCT01809106|Secondary|Proportion of Full-responder|Evaluation of the proportion of subjects who report full analgesia (full responders: FR). FR is operationally defined as a patient with a P.I.D. =/> 30% from visit 6 and visit 1 (NRS 0 to 10).|28 days|||participants|||Number
663094|NCT01809106|Primary|Proportion of Non-Responder (NR) Participants|Evaluation of the proportion of Non-Responder (NR) participants. NR correspond to the subjects who do not report any analgesic effects, with a P.I.D. (pain intensity difference) from visit 6 and visit 1 =/< 0%, (using a 0-10 NRS ). It includes the situations of average pain intensity “stable” or “worsened” at day 28 compared with baseline values.|28 days|Intention-to-treat||participants|||Number
663095|NCT01809054|Secondary|Deep Vein Thrombosis|verified by ultrasound|6 weeks|||participants|||Number
663096|NCT01809054|Primary|Blood Loss|requiring transfusion|6 weeks|||participants|||Number
663097|NCT01808963|Primary|Evaluation of Respiratory Heat Loss as a Physiologic Patient Monitor for Acute Care Medicine|Respired gas heat content|1 year.|||Joules per minute||Standard Deviation|Mean
663098|NCT01808950|Secondary|Global Judgment of Tolerability by Investigator by Means of a 6-point Scale||8 weeks after a maximal treatment period of 4 weeks||||||
663099|NCT01808950|Secondary|Evaluation of Systemic Tolerability Based on Haematology and Blood Chemistry Values and Vital Signs||up to 12 weeks||||||
663100|NCT01808950|Secondary|Evaluation of Local Tolerability by Means of 5-point Scales|local skin reactions as erythema, edema, erosion/ulceration, exudate, dryness, encrustation judged by investigator by means of 5-point scales (0 = absent, 1 = slight, 2 = moderate, 3 = severe, 4 = very severe).|up to 12 weeks||||||
663101|NCT01808950|Secondary|Complete Clinical Clearance Rate||8 weeks after the 4 weeks treatment period|data were not collected for any of study participant.|||||
663102|NCT01808950|Primary|Histological Cure Rate||8 weeks after a maximal treatment period of 4 weeks|data were not collected for any of study participant.|||||
663103|NCT01808755|Primary|Days|time required to develop the next urinary tract infection; evaluation by means of urine analysis and urine culture|168|||days||Standard Deviation|Mean
663104|NCT01808651|Secondary|Change From Baseline to Week 52 in Sheehan Disability Scale (SDS) Total Score and Subscale Scores|SDS was completed by the participant and was used to assess the effect of the participant's symptoms on their work/school (Item 1), social life/leisure activities (Item 2), and family life/home responsibilities (Item 3). Each item was measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. Total score was the sum of the 3 items and ranged from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. LS means were calculated using analysis of covariance (ANCOVA) adjusting for treatment, pooled investigative site, and baseline SDS score.|Baseline up to 52 weeks|Participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline SDS score. Missing endpoints were imputed with the last observation carried forward (LOCF) method, using only post-baseline data.||units on a scale||Standard Error|Least Squares Mean
663227|NCT01808209|Primary|Eye Whiteness|Participant rating for eye whiteness. Collected at baseline for habitual lenses. (0-100, 0= total redness and 100= totally white).|1 Week|All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.||units on a scale||Standard Deviation|Mean
663105|NCT01808651|Secondary|Mean Change From Baseline to Week 52 on the HAMD21 Subscale Scores|HAMD17 total scores and subscale scores from the HAMD21 are presented. HAMD17 is a 17-item assessment of depression severity (total scores range from 0-52). The Maier subscale (Items 1, 2, 7-10) represents the core symptoms of depression (0-24). Anxiety/Somatization subscale (Items 10-13, 15, 17) evaluates severity of psychic and somatic manifestations of anxiety as well as agitation (0-18). Retardation/Somatization subscale (Items 1, 7, 8, 14) evaluates dysfunction in mood, work, and sexual activity, as well as overall motor retardation (0-14). Sleep subscale (Items 4-6) assesses insomnia (0-6). Individual item scores may range from 0-4 or 0-2. Higher scores indicate more severe symptoms. LS means were calculated using MMRM adjusting for the random effect of participant and fixed categorical effects of treatment, pooled investigative site, visit, and treatment-by-visit interaction, as well as the continuous fixed covariate of baseline score.|Baseline, Week 52|Participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline HAMD21 subscale score. LSM (least square mean) and SE (standard error) are from visit 16.||units on a scale||Standard Error|Least Squares Mean
663106|NCT01808651|Secondary|Mean Change From Baseline to Week 52 on the Clinical Global Impression of Severity (CGI-S) Scale|CGI-S measures severity of illness at the time of assessment with scores ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). LS means were calculated using MMRM adjusting for the random effect of participant and fixed categorical effects of treatment, pooled investigative site, visit, and treatment-by-visit interaction, as well as the continuous fixed covariate of baseline CGI-S score.|Baseline, Week 52|Participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline CGI-S score during the Treatment Period.||units on a scale||Standard Error|Least Squares Mean
663107|NCT01808651|Secondary|Percentage of Participants Achieving a Remission at Week 52|The percentage of participants achieving a remission (defined as a HAMD21 total score ≤7) was calculated by dividing the number of participants achieving a remission at last observation by the total number of participants at risk, multiplied by 100.|up to Week 52|Participants who received at least 1 dose of study drug with a baseline (which had not achieved remission threshold criteria) and had at least 1 post-baseline HAMD21 total score during the Treatment Period. Missing endpoints were imputed with the last observation carried forward (LOCF) method, using only post-baseline data.||percentage of participants|||Number
663108|NCT01808651|Secondary|Percentage of Participants Achieving a Response at Week 52|The percentage of participants achieving a response (defined as a ≥50% improvement from baseline on the HAMD21 total score) was calculated by dividing the number of participants achieving a response at last observation by the total number of participants at risk, multiplied by 100.|Baseline, up to Week 52|Participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline HAMD21 total score during the Treatment Period. Missing endpoints were imputed with the last observation carried forward (LOCF) method, using only post-baseline data.||Percentage of participants|||Number
663109|NCT01808651|Secondary|Mean Change From Baseline to Week 52 on the 21-Item Hamilton Depression Rating Scale (HAMD21) Total Score|HAMD21 is a 21-item assessment used to measure depression severity. Items were rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score ranging from 0 (not at all depressed) to 64 (severely depressed). Least squares (LS) means were calculated using mixed-model repeated measures (MMRM) adjusting for the random effect of participant and fixed categorical effects of treatment, pooled investigative site, visit, and treatment-by-visit interaction, as well as the continuous fixed covariate of baseline HAMD21 total score.|Baseline, Week 52|Participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline HAMD21 total score during Study Period 1.||units on a scale||Standard Error|Least Squares Mean
663110|NCT01808651|Primary|Number of Participants With Suicidal Behaviors and Ideations Collected by Columbia - Suicide Severity Rating Scale (C-SSRS)|"C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior is defined as a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation is defined as a yes answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation."|Baseline through Week 52|Participants who received at least 1 dose of study drug with at least 1 post-baseline C-SSRS score during Study Period 1.||participants|||Number
663111|NCT01808651|Primary|Number of Participants With Adverse Events (AEs) or Serious AEs (SAEs)||Baseline through Week 52.|Participants who received at least 1 dose of the study drug were evaluated for AEs and SAEs. SAE reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 1.||participants|||Number
663112|NCT01808612|Secondary|Number of Participants With Suicidal Behaviors and Ideations Collected by Columbia - Suicide Severity Rating Scale (C-SSRS)|"C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior is defined as a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation is defined as a yes answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation."|Baseline through 6 weeks|Randomized participants who received at least 1 dose of study drug with at least 1 post-baseline C-SSRS score during the Treatment Period.||participants|||Number
663113|NCT01808612|Secondary|Mean Change From Baseline to 6-Week Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscale Scores|SDS was completed by the participant and was used to assess the effect of the participant's symptoms on their work/school (Item 1), social life/leisure activities (Item 2), and family life/home responsibilities (Item 3). Each item was measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. Total score was the sum of the 3 items and ranged from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. LS means were calculated using analysis of covariance (ANCOVA) adjusting for treatment, pooled investigative site, and baseline SDS score.|Baseline, up to 6 weeks|Randomized participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline SDS score during the Treatment Period. Missing endpoints were imputed with the last observation carried forward (LOCF) method, using only postbaseline data.||units on a scale||Standard Error|Least Squares Mean
663228|NCT01808209|Primary|Eye Whiteness|Participant rating for eye whiteness. Collected at baseline for habitual lenses. (0-100, 0= total redness and 100= totally white).|Baseline|||units on a scale||Standard Deviation|Mean
663114|NCT01808612|Secondary|Mean Change From Baseline to 6-Week Endpoint on the Clinical Global Impression of Severity (CGI-S) Scale|CGI-S measures severity of illness at the time of assessment with scores ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). LS means were calculated using MMRM adjusting for the random effect of participant and fixed categorical effects of treatment, pooled investigative site, visit, and treatment-by-visit interaction, as well as the continuous fixed covariate of baseline CGI-S score.|Baseline, 6 weeks|Randomized participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline CGI-S score during the Treatment Period.||units on a scale||Standard Error|Least Squares Mean
663115|NCT01808612|Secondary|Percentage of Participants Achieving a Remission at 6-Week Endpoint|The percentage of participants achieving a remission (defined as a HAMD21 total score ≤7) was calculated by dividing the number of participants achieving a remission at last observation by the total number of participants at risk, multiplied by 100.|up to 6 weeks|Randomized participants who received at least 1 dose of study drug with a baseline (which had not achieved remission threshold criteria) and had at least 1 post-baseline HAMD21 total score during the Treatment Period. Missing endpoints were imputed with the last observation carried forward (LOCF) method, using only post-baseline data.||percentage of participants|||Number
663116|NCT01808612|Secondary|Percentage of Participants Achieving a Response at 6-Week Endpoint|The percentage of participants achieving a response (defined as a ≥50% improvement from baseline on the HAMD21 total score) was calculated by dividing the number of participants achieving a response at last observation by the total number of participants at risk, multiplied by 100.|up to 6 weeks|Randomized participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline HAMD21 total score during the Treatment Period. Missing endpoints were imputed with the last observation carried forward (LOCF) method, using only post-baseline data.||percentage of participants|||Number
663117|NCT01808612|Secondary|Mean Change From Baseline to 6-Week Endpoint on the HAMD21 Subscale Scores|HAMD17 total scores and subscale scores from the HAMD21 are presented. HAMD17 is a 17-item assessment of depression severity (total scores range from 0-52). The Maier subscale (Items 1, 2, 7-10) represents the core symptoms of depression (0-24). Anxiety/Somatization subscale (Items 10-13, 15, 17) evaluates severity of psychic and somatic manifestations of anxiety as well as agitation (0-18). Retardation/Somatization subscale (Items 1, 7, 8, 14) evaluates dysfunction in mood, work, and sexual activity, as well as overall motor retardation (0-14). Sleep subscale (Items 4-6) assesses insomnia (0-6). Individual item scores may range from 0-4 or 0-2. Higher scores indicate more severe symptoms. LS means were calculated using MMRM adjusting for the random effect of participant and fixed categorical effects of treatment, pooled investigative site, visit, and treatment-by-visit interaction, as well as the continuous fixed covariate of baseline score.|Baseline, 6 weeks|Randomized participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline HAMD21 subscale score during the Treatment Period.||units on a scale||Standard Error|Least Squares Mean
663118|NCT01808612|Primary|Mean Change From Baseline to 6-Week Endpoint on the 21-Item Hamilton Depression Rating Scale (HAMD21) Total Score|HAMD21 is a 21-item assessment used to measure depression severity. Items were rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score ranging from 0 (not at all depressed) to 64 (severely depressed). Least squares (LS) means were calculated using mixed-model repeated measures (MMRM) adjusting for the random effect of participant and fixed categorical effects of treatment, pooled investigative site, visit, and treatment-by-visit interaction, as well as the continuous fixed covariate of baseline HAMD21 total score.|Baseline, 6 weeks|Randomized participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline HAMD21 total score during the Treatment Period.||units on a scale||Standard Error|Least Squares Mean
663119|NCT01808547|Primary|Ocular Inflammation|"Anterior chamber cell grade 0 at Day 15 measured on a 0 to 4 scale where 0 is 0 cells; 1 is 1-10 cells; 2 is 11-20 cells; 3 is 21-50 cells; 4 is > 50 cells, and no rescue medications."|15 days|Modified Intent-to-Treat (ITT) Population using Last Observation Carried Forward (LOCF) method.||participants|||Number
663120|NCT01808534|Secondary|Treatment Related Adverse Events Grade 3 or Higher|Number of unique patients who had a treatment related (possible, probable or definite) adverse event that was graded 3 or greater according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03.|Up to 2 years|All patients who enrolled and received treatment.||participants|||Number
663121|NCT01808534|Secondary|Overall Survival|Summarized by Kaplan-Meier methods including 90% confidence intervals for the median using method of Brookmeyer and Crowley. Time until death or last evaluation will be calculated. If a patient did not die, they will be censored in the analysis at their last known alive date.|Up to 2 years|All patients who enrolled and received treatment.||months||90% Confidence Interval|Median
663122|NCT01808534|Secondary|Progression Free Survival (PFS)|Summarized by Kaplan-Meier methods including 90% confidence intervals for the median using method of Brookmeyer and Crowley. Time until progression, death or last evaluation will be calculated. If a patient did not progress or die, they will be censored at their last evaluation in the analysis.|Up to 2 years|All patients who enrolled and received treatment.||months||90% Confidence Interval|Median
663123|NCT01808534|Secondary|Duration of Remission in Patients Who Achieve a Partial or Complete Response|The duration of remission is from the time of confirmed partial or complete response until progression or death. Patients continuing in remission at the end of the study will be treated as censored. Summarized by Kaplan-Meier methods including 90% confidence intervals for the median using method of Brookmeyer and Crowley. Note: There were no patients who achieved partial or complete response.|Up to 2 years|||months||90% Confidence Interval|Median
663124|NCT01808534|Primary|Overall Response Rate (Defined as Partial Response or Complete Response)|The percent of patients who were shown as having a partial remission or better based on definitions of response in RECIST 1.1. At least a 30% decrease in the sum of the diameters of target lesions, in reference to baseline sum diameters, needs to be confirmed to be considered as partial response or better. Note: There were no patients with a partial or complete response.|Up to 2 years|All patients who enrolled and received treatment with at least one post baseline assessment.||percentage of participants||95% Confidence Interval|Number
663125|NCT01808508|Secondary|Change in the Distance Walked on a 6 Minute Walk Test From Baseline to 4 Months|As secondary outcome of the second aim, we will use the distance walked during the 6 minute walk test.|4 Months|The majority of subjects were unable to follow instructions properly and therefore none could successfully complete the test. Thus the results were not considered to be valid.|||||
663126|NCT01808508|Secondary|Change in the Left Ventricular (LV) Mass Index Score From Baseline to 4 Months|The change in left ventricular mass index score, measured on echocardiography, was used to assess the relationship between obstructive sleep apnea syndrome and cardiovascular function of individuals with Down syndrome. Left ventricular (LV) mass was calculated from M-mode measurements of the LV end-diastolic dimension, the thickness of the interventricular septum and the thickness of the LV posterior wall, and presented as a z-score.|4 Months|1 OSAS subject randomized to CPAP did not return for follow-up||z-score||Inter-Quartile Range|Median
663127|NCT01808508|Secondary|Change in Child Behavior Checklist (CBCL) Total Score From Baseline to 4 Months|The change in behavioral domain was measured by the Child Check Behavior List. The CBCL is a widely used method of identifying problem behavior in children. Problems are identified by a respondent who knows the child well, usually a parent or other care giver. There are 2 versions based on the child's age (CBCL/1½-5 for use children 18 months-5 years; the CBCL/6-18 for children aged 6-18 years). The checklists consists of a number of statements about the child's behavior and responses are recorded on a scale: 0 = Not True, 1 = Somewhat or Sometimes True, 2 = Very True or Often True. The preschool checklist contains 100 questions and, school-age checklist contains 120 questions. 8 sub-scores (1 for each of 8 syndromes: anxious/depressed, withdrawn depressed, somatic complaints, social problems, thought problems, attention problems, rule-breaking behavior and aggressive behavior) are calculated, each ranging from 0 (normal) to 16 (clinical behavior).|4 Months|1 OSAS subject randomized to CPAP did not return for follow-up||units on a scale||Inter-Quartile Range|Median
663128|NCT01808508|Primary|Change in Epworth Sleepiness Scale From Baseline to End of Study|The primary aim of the study is to assess the relationship between obstructive sleep apnea syndrome (OSAS) and the neurocognitive and behavioral outcomes of individuals with Down syndrome. Sleepiness was assessed using the pediatric version of the Epworth Sleepiness Scale (ESS). The ESS is a self-administered questionnaire with 8 questions. It provides a measure of a person’s general level of daytime sleepiness, or average sleep propensity in daily life. The ESS asks people to rate, on a 4-point scale (0, low to 3, high) their usual chances of dozing off or falling asleep in 8 different situations or activities that most people engage in as part of their daily lives. The total ESS score provides an estimate of a general characteristic of each person's average level of sleepiness in daily life (0= no chance of dozing/no daytime sleepiness to 24=high chance of dozing/lots of daytime sleepiness).|4 Months|1 OSAS subject randomized to CPAP did not return for follow-up||units on a scale||Inter-Quartile Range|Median
663129|NCT01808339|Secondary|Peak Expiratory Flow (PEF)|PEF is a measure of lung function and is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. AM and PM pre-treatment PEF was measured throughout the study for the purposes of monitoring participants’ asthma stability, and was measured from the start of the Run-in Period until completion of Treatment Period 3 (including during the washout periods), prior to study medication and/or any rescue albuterol/salbutamol inhalation aerosol use. The data collected were only assessed by the Investigator on an individual basis during the study and were not formally summarized or statistically analyzed; consequently, data are not reported.|Up to 18 weeks||||||
663130|NCT01808339|Secondary|Number of Participants With Any Adverse Event (AE)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs were collected from the start of dosing with investigational product and until follow-up.|Up to 18 weeks|All Subjects Population: all participants who received at least one dose of study medication||Participants|||Number
663131|NCT01808339|Secondary|Pre-treatment AM and PM Trough FEV1 on Day 14 of Each Treatment Period|FEV1 is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using site equipment (KoKo Pneumotach Spirometer). FEV1 PM trough FEV1 values were the values taken pre-treatment on Day 14, and AM trough FEV1 values were the values taken pre-treatment on Day 15 in each treatment period; thus, there is only one value (pre-treatment record) per period for AM and PM trough.|Day 14 of each treatment period (up to Study Day 105)|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study medication, and had at least one Baseline and post-dose FEV1 measurement performed. Only those participants available at the specified time points were analyzed||Liters||Standard Error|Least Squares Mean
663132|NCT01808339|Primary|Weighted Mean Forced Expiratory Volume in 1 Second (FEV1) Measured Over 24 Hours at Day 14 of Each Treatment Period|FEV1 is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using site equipment (KoKo Pneumotach Spirometer). Weighted mean FEV1 was calculated using the Day 14 24-hour serial FEV1 measurements taken at 3, 6, 9, 12, 15, 18, 21, and 24 hours post-dose (measured in the evening of Day 15). At each time point, the highest of three technically acceptable measurements was recorded. FEV1 weighted mean was analyzed using a mixed effects analysis of a covariance model with fixed effect terms for treatment and period, participant Baseline, period Baseline, gender, and age as covariates, and participant as a random effect.|24 hours post-PM dose on Day 14 of each treatment period (up to Study Day 105)|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study medication, and had at least one Baseline and post-dose FEV1 measurement performed. Only those participants with non-missing covariates and a post-Baseline FEV1 measurement were analyzed.||Liters||Standard Error|Least Squares Mean
663133|NCT01808326|Secondary|Time of Maximum Serum Concentration (Tmax) for Phenyl Acetic Acid Mustard|Blood samples for pharmacokinetic (PK) analysis of chlorambucil and its metabolite phenyl acetic acid mustard were collected on Day 1 and Day 4 in Cycle 1, and on Day 57 in Cycle 3. In each sampling, blood samples (2 mL/sample) were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr post dosing. Time of maximum serum concentration (tmax) was determined. Between participants coefficient of variation (%CVb) was calculated according to the following methods: Transformed Data : 100 * (square root of the exponential [standard deviation of loge-transformed ]2-1).|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||Hour||Full Range|Median
663229|NCT01808209|Primary|Vision Quality|Participant rating of vision quality. Collected at 1 week. (0-100; 0=extremely poor vision totally blurred 100=excellent vision totally sharp)|1 Week|All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.||units on a scale||Standard Deviation|Mean
663134|NCT01808326|Secondary|Elimination Half-life (t1/2) for Phenyl Acetic Acid Mustard|Blood samples for pharmacokinetic (PK) analysis of chlorambucil and its metabolite phenyl acetic acid mustard were collected on Day 1 and Day 4 in Cycle 1, and on Day 57 in Cycle 3. In each sampling, blood samples (2 mL/sample) were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr post dosing. Elimination half-life (t1/2) was determined. Between participants coefficient of variation (%CVb) was calculated according to the following methods: Transformed Data : 100 * (square root of the exponential [standard deviation of loge-transformed ]2-1).|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||Hour||95% Confidence Interval|Geometric Mean
663135|NCT01808326|Secondary|Area Under the Serum Concentration-time (AUC) for Phenyl Acetic Acid Mustard|Blood samples for PK analysis of chlorambucil and its metabolite phenyl acetic acid mustard were collected on Day 1 and Day 4 in Cycle 1, and on Day 57 in Cycle 3. In each sampling, blood samples (2 mL/sample) were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr post dosing. AUC from time zero up to a definite time t (AUC[0-t]), AUC from time zero up to infinity (AUC[0-inf]), AUC from time zero up to 6 hours post dose (AUC[0-6]), AUC from time zero up to 24 hours post dose (AUC[0-24]) were determined. Between participants coefficient of variation (%CVb) was calculated according to the following methods: Transformed Data : 100 * (square root of the exponential [standard deviation of loge-transformed ]2-1).|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||Hour*nanogram/ milliliter/milligram||95% Confidence Interval|Geometric Mean
663136|NCT01808326|Secondary|Maximum Serum Concentration (Cmax), and Minimum Serum Concentration (Cmin) for Phenyl Acetic Acid Mustard|Blood samples for pharmacokinetic (PK) analysis of chlorambucil and its metabolite phenyl acetic acid mustard were collected on Day 1 and Day 4 in Cycle 1, and on Day 1 in Cycle 3. In each sampling, blood samples (2 milliliter [mL]/sample) were collected at pre-dose, and 15 minute (min), 30 min, 1 hour (hr), 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr post dosing. Maximum serum concentration (Cmax), minimum serum concentration (Cmin) were determined. Between participants coefficient of variation (%CVb) was calculated according to the following methods: Transformed Data : 100 * (square root of the exponential [standard deviation of loge-transformed ]2-1).|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 1|PK Population: all participants who received at least one dose of investigational product and for whom PK data was collected. Only those participants with non-missing values available at the specified time points were analyzed (represented by n=X in the category titles).||Nanograms per milliliter||95% Confidence Interval|Geometric Mean
663137|NCT01808326|Secondary|Time of Maximum Serum Concentration (Tmax) for Chlorambucil|Blood samples for pharmacokinetic (PK) analysis of chlorambucil were collected on Day 1 and Day 4 in Cycle 1, and on Day 57 in Cycle 3. In each sampling, blood samples (2 mL/sample) were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr post dosing. Time of maximum serum concentration (tmax) was determined. Between participants coefficient of variation (%CVb) was calculated according to the following methods: Transformed Data : 100 * (square root of the exponential [standard deviation of loge-transformed ]2-1).|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||Hour||Full Range|Median
663138|NCT01808326|Secondary|Elimination Half-life (t1/2) for Chlorambucil|Blood samples for pharmacokinetic (PK) analysis of chlorambucil were collected on Day 1 and Day 4 in Cycle 1, and on Day 57 in Cycle 3. In each sampling, blood samples (2 mL/sample) were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr post dosing. Elimination half-life (t1/2) was determined. Between participants coefficient of variation (%CVb) was calculated according to the following methods: Transformed Data : 100 * (square root of the exponential [standard deviation of loge-transformed ]2-1).|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||Hour||95% Confidence Interval|Geometric Mean
663139|NCT01808326|Secondary|Area Under the Serum Concentration-time (AUC) for Chlorambucil|Blood samples for PK analysis of chlorambucil were collected on Day 1 and Day 4 in Cycle 1, and on Day 57 in Cycle 3. In each sampling, blood samples (2 mL/sample) were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr post dosing. AUC from time zero up to a definite time t (AUC[0-t]), AUC from time zero up to infinity (AUC[0-inf]), AUC from time zero up to 6 hours post dose (AUC[0-6]), AUC from time zero up to 24 hours post dose (AUC[0-24]) were determined. Between participants coefficient of variation (%CVb) was calculated according to the following methods: Transformed Data : 100 * (square root of the exponential [standard deviation of loge-transformed ]2-1).|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||Hour*nanogram/ milliliter/milligram||95% Confidence Interval|Geometric Mean
663163|NCT01808313|Secondary|Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points up to Week 24|Blood samples were collected for the measurement of mean corpuscle volume at the Baseline visit and Weeks 4, 8, 12, 16, 20 and 24. Change from Baseline in the mean corpuscle volume values were summarized for each post-Baseline assessment until Week 24. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. The Baseline value is defined as the last pre-treatment value observed.|Baseline up to Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.||Femtoliters||Standard Deviation|Mean
663140|NCT01808326|Secondary|Maximum Serum Concentration (Cmax), and Minimum Serum Concentration (Cmin) for Chlorambucil|Blood samples for pharmacokinetic (PK) analysis of chlorambucil were collected on Day 1 and Day 4 in Cycle 1, and on Day 1 in Cycle 3. In each sampling, blood samples (2 milliliter [mL]/sample) were collected at pre-dose, and 15 minute (min), 30 min, 1 hour (hr), 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr post dosing. Maximum serum concentration (Cmax), minimum serum concentration (Cmin) were determined. Between participants coefficient of variation (%CVb) was calculated according to the following methods: Transformed Data : 100 * (square root of the exponential [standard deviation of loge-transformed ]2-1).|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 1|PK Population: all participants who received at least one dose of investigational product and for whom PK data was collected. Only those participants with non-missing values available at the specified time points were analyzed (represented by n=X in the category titles).||Nanograms per milliliter||95% Confidence Interval|Geometric Mean
663141|NCT01808326|Secondary|Expression of Complement CH50|Peripheral samples were collected for the analysis of complement CH50 at Baseline (Day 1 of Cycle 1) and after completion of Cycle 4 (Day 85).|Baseline, Cycle 1-Day 1, and Cycle 4-Day 85|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Kilounit /Liter||Standard Deviation|Mean
663142|NCT01808326|Secondary|Expression of Beta 2 Microglobulin|Blood samples were collected at the Baseline (Day 1 of Cycle 1) visit for prognostic biomarker Beta 2 microglobulin measurements.|Baseline (Cycle 1 Day 1)|All Subjects Population||Nanomoles per Liter||Standard Deviation|Mean
663143|NCT01808326|Secondary|Number of Participants With Positive Minimal Residual Disease (MRD)|MRD refers to the small number of leukemic cells that remain in the participant during treatment or after treatment at the time the participant achieved a confirmed CR and in whom bone marrow test was performed. A bone marrow sample was examined by flow cytometry (Cluster of differentiation [CD]5, CD19, CD20, and CD23). MRD positive is defined as more than one CLL cell per 10000 leukocytes.|From the start of treatment up to Week 61.1|All Subjects Population||Participants|||Number
663144|NCT01808326|Secondary|Change From Baseline in the Immunoglobulin(Ig) Antibodies IgA, IgG, and IgM|Immunoglobulins, or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Low levels indicate immuno-suppression. IgA, IgG, and IgM were measured in the blood samples of the participants.Peripheral samples were collected for the analysis of IgA, IgG, and IgM at Baseline and 28 days after Day 1 of the last treatment cycle (FU 1-PDFU 1) for all participants, and 168 days after day of FU 1-PDFU 1 for participants with CR, PR, and SD. Baseline was the last pre-dose assessment performed on Cycle 1-Day 1. The the last assessment performed prior to pre-dose Cycle 1-Day 1 was used if Cycle 1-Day 1 was missing. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline, FU 1-PDFU 1, FU 85-PDFU 85, and FU 169-PDFU 169|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Grams per liter||Standard Deviation|Mean
663145|NCT01808326|Secondary|Number of Participants With at Least One Grade 3/Grade 4 Adverse Event of Infection or Myelosuppression (Anemia, Neutropenia, and Thrombocytopenia)|Number of participants with a Grade 3 or Grade 4 adverse event of infection or myelosuppression (anemia, neutropenia, and thrombocytopenia) are presented. Myelosuppression is defined as the decrease in the ability of the bone marrow to produce blood cells. AEs were graded according to NCI common terminology criteria for adverse events (CTCAE) grade, version 3.0 (1, mild; 2, moderate; 3, severe; 4, life-threatening/disabling; 5, death).|From the start of treatment up to Week 61.1|All Subjects Population||Participants|||Number
663146|NCT01808326|Secondary|Number of Participants With Adverse Events by the Indicated Maximum Toxicity Grade|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product. Non-hematologic AEs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 (NCI CTCAE V4.03): Grade 0, none; Grade 1, mild; Grade 2, moderate; Grade 3, severe or medically significant; Grade 4, life-threatening consequences; Grade 5, death related to AE|From the start of treatment up to Week 61.1|All Subjects Population||Participants|||Number
663147|NCT01808326|Secondary|Number of Participants With Any Adverse Events (AE) or Serious Adverse Events (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product. A SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, is a congenital anomaly/birth defect or is associated with protocol specified liver injury and impaired liver function or is any protocol specific AEs.|From the start of treatment up to Week 61.1|All Subjects Population||Participants|||Number
663148|NCT01808326|Secondary|Number of Participants With no B-symptoms and With at Least One B-symptom Over Time|The number of participants with no B-symptoms (no night sweat, no weight loss, no fever and no extreme fatigue) and the number of participants with at least one of the B-symptoms are summarized by assessment time. The presence of the B-symptoms was assessed at Baseline, Day 1 of each treatment cycle and follow-up (FU). Baseline was the last pre-dose assessment performed at C1 D1.|Baseline, C2-D29, C3-D57, C4-D85, C5-D113, C6-D141, C7-D169, C8-D197, C9-D225, FU 1-PDFU 1, FU 85-PDFU 85, and FU 169-PDFU 169|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Participants|||Number
663180|NCT01808313|Secondary|Change From Baseline in 6MWT at Week 24|The 6MWT measures the distance that a participant can walk in a period of 6 minutes. Change from Baseline was calculated as the Week 24 value minus the Baseline value. Baseline 6MWT comprised of an average of the last two consecutive measurements prior to dosing that varied by not greater than 10%. If only one measurement was available, that measurement was used as the Baseline value. The last observation carried forward method was used to impute missing values.|Baseline and Week 24|ITT Population.||Meters||Standard Deviation|Mean
663149|NCT01808326|Secondary|Number of Participants With Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)|ECOG PS is a scale to assess disease progression, extent to which disease affects the daily living abilities and determines appropriate treatment and prognosis. It is scored on a scale of 0 to 5 as, 0 (fully active), 1 (restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature), 2 (ambulatory and capable of all self cares but unable to carry out any work activities, Up and about > 50% of waking hours), 3 (capable of only limited self cares, confined to bed or chair > 50% of waking hours), 4 (completely disabled, cannot carry on any self cares, totally confined to bed or chair), 5 (death). Improvement is defined as decrease from baseline by at least one step on the ECOG performance status scale (yes/no). Baseline was last pre-dose assessment performed on Cycle 1 Day 1(C1 D1). When C1 D1 was missing, the last assessment performed prior to pre-dose C1 D1 was used. It was performed on Day 1 of each cycle and follow-up (FU).|Baseline, Cycle (C) 2-Day (D) 29, C3-D57, C4-D85, C5-D113, C6-D141, C7-D169, C8-D197, C9-D225, FU 1- PDFU 1, FU 85-PDFU 85, and FU 169-PDFU 169|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Participants|||Number
663150|NCT01808326|Secondary|Time to Next Chronic Lymphocytic Leukemia (CLL) Therapy|Time to next CLL therapy is defined as the time from start of treatment until the first administration of the next CLL treatment other than chlorambucil administrations scheduled in this study. Time to next CLL therapy was restricted to the subgroup of the population who receive a next CLL therapy after experiencing disease progression.|From the start of treatment until the first administration of the next CLL treatment (up to Week 61.1)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Weeks||95% Confidence Interval|Median
663151|NCT01808326|Secondary|Duration of Response, as Assessed by the IRC|Duration of response is defined as the time from the initial response (CR or PR) until progression or death. CR (all the criteria at least 2 months after last treatment): no lymphadenopathy (Ly) > 1.5 cm/ hepatomegaly/ splenomegaly/ constitutional symptoms; neutrophils >1500 per microliter (µL), platelets (PL) >100,000/µL, hemoglobin (Hb) >11 grams/deciliter (g/dL), lymphocytes (LC) <4000/µL, bone marrow (BM) sample must be normocellular for age, <30% LC, no lymphoid nodule. CRi: CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to CLL but related to drug toxicity. PR: >=50% decrease in LC, Ly, size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline (BL), Hb >11 g/dL or 50% improvement over BL. nPR: persistent nodules BM.|From the initial response (CR/PR) until disease progression or death (up to Week 61.1)|All Subjects Population||Weeks||95% Confidence Interval|Median
663152|NCT01808326|Secondary|Time to Response, as Assessed by the IRC|Time to response is defined as time from the start of treatment until the first response (CR/PR). Time to Response analyses was restricted to the subgroup of the population who experienced an overall response (CR/ nPR/CRi/PR) during the study. CR (all the criteria at least 2 months after last treatment): no lymphadenopathy (Ly) > 1.5 cm/ hepatomegaly/ splenomegaly/ constitutional symptoms; neutrophils >1500 per microliter (µL), platelets (PL) >100,000/µL, hemoglobin (Hb) >11 grams/deciliter (g/dL), lymphocytes (LC) <4000/µL, bone marrow (BM) sample must be normocellular for age, <30% LC, no lymphoid nodule. CRi: CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to CLL but related to drug toxicity. PR: >=50% decrease in LC, Ly, size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline (BL), Hb >11 g/dL or 50% improvement over BL. nPR: persistent nodules BM.|From the start of treatment until the first response (CR/PR) (up to Week 61.1)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Weeks||95% Confidence Interval|Median
663153|NCT01808326|Secondary|Overall Survival (OS)|Overall survival is defined as time from the start of treatment until death due to any cause. Participants who had not died were censored at the date of last contact.|From the start of treatment until death (up to Week 61.1)|All Subjects Population||Weeks||95% Confidence Interval|Median
663154|NCT01808326|Secondary|Progression Free Survival (PFS), as Assessed by the Investigator and the IRC|Progression-free survival (PFS) is defined as the time from the start of treatment of investigational product until the first documented sign of PD or death due to any cause. PD requires at least one of the following: lymphadenopathy, appearance of any new lesion such as enlargerd lymph nodes (>1.5 cm) spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site; an increase by 50% or more in the previously noted enlargement of the liver or spleen, an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter, transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukaemia. Par. who were alive and had not progressed at the time of analysis or if a progression event or death occurred after extensive lost-to-follow-up time or if new anti-cancer therapy was started were censored at the date of the last visit with adequate assessment.|From the start of treatment until disease progression or death (up to Week 61.1)|All Subjects Population||Weeks||95% Confidence Interval|Median
663155|NCT01808326|Secondary|Number of Participants With the Best Overall Response (OR), as Assessed by the Investigator, IRC and IRC With CT|OR is defined as the number of participants achieving either a confirmed CR or PR. Assessment was completed by the Investigator, IRC, and IRC with CT. CR (all the criteria at least 2 months after last treatment): no lymphadenopathy (Ly) > 1.5 cm/ hepatomegaly/ splenomegaly/ constitutional symptoms; neutrophils >1500 per microliter (µL), platelets (PL) >100,000/µL, hemoglobin (Hb) >11 grams/deciliter (g/dL), lymphocytes (LC) <4000/µL, bone marrow (BM) sample must be normocellular for age, <30% LC, no lymphoid nodule. CRi: CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to CLL but related to drug toxicity. PR: >=50% decrease in LC, Ly, size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline (BL), Hb >11 g/dL or 50% improvement over BL. nPR: persistent nodules BM.|From the start of treatment until disease progression or death (up to Week 61.1)|All Subjects Population||Participants|||Number
663156|NCT01808326|Primary|Number of Participants With a Best Response of Either Complete Remission (CR), Nodular Partial Remission (nPR), Complete Remission-incomplete (CRi) or Partial Remission (PR), as Assessed by the Investigator, IRC and IRC With CT|According to the criteria based on the 2008 revision of the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) of the National Cancer Institute-Sponsored Working Group Guidelines (NCI-WG), participants with complete remission (CR), nodular partial remission (nPR), complete remission-incomplete (CRi) and partial remission (PR) were classified as responders, while stable disease (SD) and progressive disease (PD) were classified as non-responders. Participants with unknown or missing responses were considered as non-responders. Assessment was completed by the Investigator, Independent Review Committee (IRC), and IRC with Computed Tomography (CT).|From the start of treatment until disease progression or death (up to Week 61.1)|All Subjects Population: all participants who received at least one dose of investigational product.||Participants|||Number
663157|NCT01808313|Secondary|Number of Participants With Urinalysis Data at Baseline and Week 24|Urine samples were collected for urinalysis at Baseline and Week 24. The Number of participants with urinalysis to negative and positives (trace, +, ++ and +++) data at Baseline and Week 24 are summarized for urine bilirubin (UBIL), urine glucose (UGLU), urine ketones (UKET), urine nitrite (UNIT), urine protein (UM) and urine urobilinogen (UUBIL) were performed with dipstick method. Other urinalysis parameters included urine pH (UpH), urine specific gravity (USG). The Baseline value is defined as the last pre-treatment value observed.|Baseline and Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.||Participants|||Number
663158|NCT01808313|Secondary|Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, Potassium, Magnesium, Sodium, Inorganic Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 24|Blood samples were collected for the measurement of calcium, cholesterol, chloride, glucose, potassium, magnesium, sodium, inorganic phosphorus, triglycerides and urea/Bun at the Baseline visit and Weeks 4, 8, 12, 16, 20 and 24. Change from Baseline in the calcium, cholesterol, chloride, glucose, potassium, magnesium, sodium, inorganic phosphorus, triglycerides and urea/BUN values were summarized for each post-Baseline assessment until Week 24. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. The Baseline value is defined as the last pre-treatment value observed.|Baseline up to Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.||Millimoles per liter||Standard Deviation|Mean
663159|NCT01808313|Secondary|Mean Change From Baseline in Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid at the Indicated Time Points up to Week 24|Blood samples were collected for the measurement of direct bilirubin, total bilirubin, creatinine and uric acid at the Baseline visit and Weeks 4, 8, 12, 16, 20 and 24. Change from Baseline in the direct bilirubin, total bilirubin, creatinine and uric acid values were summarized for each post-Baseline assessment until Week 24. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. The Baseline value is defined as the last pre-treatment value observed.|Baseline up to Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.||Micromoles per liter||Standard Deviation|Mean
663160|NCT01808313|Secondary|Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points up to Week 24|Blood samples were collected for the measurement of alkaline phosphatase (ALP), alanine amino transferase (ALT), aspartate amino transferase (AST), creatine kinase (CK), gamma glutamyl transferase (GGT) and lactate dehydrogenase (LDH) at the Baseline visit and Weeks 4, 8, 12, 16, 20 and 24. Change from Baseline in the ALP, ALT, AST, CK, GGT and LDH values were summarized for each post-Baseline assessment until Week 24. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. The Baseline value is defined as the last pre-treatment value observed.|Baseline up to Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.||International units per liter||Standard Deviation|Mean
663161|NCT01808313|Secondary|Change From Baseline in Albumin, Globulin and Total Protein at the Indicated Time Points up to Week 24|Blood samples were collected for the measurement of albumin, globulin and total protein at the Baseline visit and Weeks 4, 8, 12, 16, 20 and 24. Change from Baseline in the albumin, globulin and total protein values were summarized for each post-Baseline assessment until Week 24. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. The Baseline value is defined as the last pre-treatment value observed.|Baseline up to Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.||Grams per liter||Standard Deviation|Mean
663162|NCT01808313|Secondary|Change From Baseline in Red Blood Cell (RBC) Count at the Indicated Time Points up to Week 24|Blood samples were collected for the measurement of RBC count at the Baseline visit and Weeks 4, 8, 12, 16, 20 and 24. Change from Baseline in the red blood cell count values were summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. The Baseline value is defined as the last pre-treatment value observed.|Baseline up to Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.||Trillion cells per liter||Standard Deviation|Mean
663230|NCT01808209|Primary|Vision Quality|Participant rating of vision quality. Collected at baseline for habitual lens. (0-100; 0=extremely poor vision totally blurred 100=excellent vision totally sharp)|Baseline|||units on a scale||Standard Deviation|Mean
663164|NCT01808313|Secondary|Change From Baseline in Mean Corpuscle Hemoglobin at the Indicated Time Points up to Week 24|Blood samples were collected for the measurement of mean corpuscle hemoglobin at the Baseline visit and Weeks 4, 8, 12, 16, 20 and 24. Change from Baseline in the hemoglobin values were summarized for each post-Baseline assessment until Week 24. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. The Baseline value is defined as the last pre-treatment value observed.|Baseline up to Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.||Picogram||Standard Deviation|Mean
663165|NCT01808313|Secondary|Change From Baseline in Hematocrit at the Indicated Time Points up to Week 24|Blood samples were collected for the measurement of hematocrit at the Baseline visit and Weeks 4, 8, 12, 16, 20 and 24. Change from Baseline in the hematocrit values were summarized for each post-Baseline assessment until Week 24. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is defined as the last Pre-treatment value observed. The unit of measure is defined as the proprtion of red blood cells in blood.|Baseline up to Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.||Proportion of 1||Standard Deviation|Mean
663166|NCT01808313|Secondary|Change From Baseline in Hemoglobin at the Indicated Time Points up to Week 24|Blood samples were collected for the measurement of hemoglobin at the Baseline visit and Weeks 4, 8, 12, 16, 20 and 24. Change from Baseline in the hemoglobin count values were summarized for each post-Baseline assessment until Week 24. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. The Baseline value is defined as the last pre-treatment value observed.|Baseline up to Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.||Grams per liter||Standard Deviation|Mean
663167|NCT01808313|Secondary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell (WBC) Count at the Indicated Time Points up to Week 24|Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count and WBC count at the Baseline visit and Weeks 4, 8, 12, 16, 20 and 24. Change from Baseline in the basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count and WBC count values were summarized for each post-Baseline assessment until Week 24. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. The Baseline value is defined as the last pre-treatment value observed.|Baseline up to Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.||Giga cells per liter||Standard Deviation|Mean
663168|NCT01808313|Secondary|Number of Participants With Shift From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST) and Total Bilirubin (BILT) up to Week 24|Blood samples were collected for the measurement of ALT, ALP, AST and BILT at the Baseline visit and up to Week 24. Shift from Baseline (BL) was calculated as the individual maximum of post-BL value minus the BL value. The BL value is defined as the last pre-treatment value observed. Threshold values for the liver function test results, which were considered as potential values of clinical concern, were 3 times the upper limit of normal (ULN) for ALT, AST and ALP and 2 times the ULN for BILT. Maximum liver function abnormal values of post-BL are summarized.|Baseline up to Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.||Participants|||Number
663169|NCT01808313|Secondary|Oral Temperature|Oral temperature was used to monitor vital signs and collected at the Screening visit.|Baseline|Safety Population||Celsius||Full Range|Mean
663170|NCT01808313|Secondary|Change From Baseline in Heart Rate at the Indicated Time Points up to Week 24|Vital sign monitoring included heart rate measurements at (pre-6MWT and post-6MWT at the Baseline visit, Weeks 4, 8, 12, 16, 20 and 24. Change from Baseline in heart rate was summarized for each post-Baseline assessment up to Week 24. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. The Baseline value is defined as the last non-missing value observed before treatment. At Baseline, Weeks 12 and 28, heart rate was recorded at the end of the 6MWT and at 1 minute (M), 2 M and 3 M, after completion of the 6MWT with the participants seated, and the time that heart rate recovered to the level of pre-6MWT.|Baseline up to Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.||Beats per minute||Standard Deviation|Mean
663171|NCT01808313|Secondary|Change From Baseline in Systolic and Diastolic Blood Pressure at the Indicated Time Points up to Week 24|Blood pressure measurements (pre-6MWT and post-6MWT) were taken to monitor vital signs and included systolic blood pressure (SBP) and diastolic blood pressure (DBP) at the Baseline, Weeks 4, 8, 12, 16, 20 and 24. Change from Baseline in SBP and DBP were summarized for each post-Baseline assessment upto Week 24. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. The Baseline value is defined as the last non-missing observed value before treatment.|Baseline up to Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.||Millimeters of mercury (mmHg)||Standard Deviation|Mean
663204|NCT01808261|Secondary|Number of Falls Over Time|The number of participants who experienced 1, 2, 3 or >=4 falls between BL to Day 90 and BL to Day 180 is summarized. By-visit sample sizes vary due to missing data or early termination of the study. The participants who experienced atleast one-fall were reported|BL (Day 1), Day 90 and Day 180|Safety Population.||Participants|||Count of Participants
663172|NCT01808313|Secondary|Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Interval Corrected Bazett's Formula (QTcB) Values at Weeks 12 and 24|The ECG parameters, PR interval, QRS duration, uncorrected QT interval, QTcB were measured at Baseline, Weeks 12 and 24. Change from Baseline in ECG heart rate is summarized for each post-Baseline assessment up to Week 24. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. The Baseline value is defined as the last non-missing observed value before treatment.|Baseline, Week 12 and Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.||Milliseconds||Standard Deviation|Mean
663173|NCT01808313|Secondary|Change From Baseline in Electrocardiogram (ECG) Heart Rate Values at Weeks 12 and 24|Heart rate was measured in order to monitor vital signs by the 12-lead ECG at Baseline, Weeks 12 and 24. Change from Baseline in ECG heart rate is summarized for each post-Baseline assessment at Weeks 12 and 24. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. The Baseline value is defined as the last non-missing observed value before treatment.|Baseline, Week 12 and Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.||Beats per minute||Standard Deviation|Mean
663174|NCT01808313|Secondary|Number of Participants With Physical Examination Findings|Complete physical examinations of each participant by the investigator were performed at the Screening Visit, Week 12 and Week 24 Visit/Early withdrawal visits. The physical examination included an examination of the following: general appearance, skin, head, ears, eyes, nose, throat, neck, thyroid, lymph nodes, cardiovascular system, respiratory system, abdomen, musculoskeletal system, neurological system and height. Physical examination summary results were not collected therefore there is no data to present for this outcome measure.|Baseline, Week 12 and Week 24|Safety Population||Participants|||Number
663175|NCT01808313|Secondary|Number of Participants With Any Adverse Events, Any Serious Adverse Events and Adverse Events Leading to Discontinuation|An adverse event (AE) is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, a congenital anomaly/birth defect, or important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition.|From the start of study treatment up to Week 24|Safety Population||Participants|||Number
663176|NCT01808313|Secondary|Number of Participants With the Indicated Event, as an Assessment of Time to Clinical Worsening of Pulmonary Arterial Hypertension (PAH) up to Week 24, Assessed as the First Occurrence of a Particular Event|Time to clinical worsening is defined as the time from Baseline to the first occurrence of death, lung transplantation, hospitalization for PAH treatment, atrial septostomy, or Investigational product (IP) discontinuation (discon) due to change to other PAH treatment. Time to clinical worsening was measured as the number of participants who experienced these events during 12 and 24 Weeks.|Baseline up to Week 24|Safety Population: This population comprised of all participants who received at least one dose of study medication.||Participants|||Number
663177|NCT01808313|Secondary|Change From Baseline in the N-Terminal Pro-B-Type Natriuretic Peptide at Weeks 12 and 24|N-Terminal Pro-B-Type Natriuretic Peptide (NT-proBNP) is a surrogate maker of heart failure and was measured by a central laboratory. Mean change from Baseline at Weeks 12 and 24 were calculated as the Weeks 12 and 24 values minus the Baseline values.Observed data was analyzed (no imputation technique was performed for missing data). Log transformed mean change from Baseline at Weeks 12 and 24 data are summarized.|Baseline, Week 12 and Week 24|ITT Population. Only those participants available at the specified time points were analyzed (represented by number of participants [n]=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflect everyone in the ITT Population.||log(ng/L)||Standard Deviation|Mean
663178|NCT01808313|Secondary|Change From Baseline in the Borg Dyspnea Index (BDI) at Weeks 12 and 24|The BDI was calculated by using a 10-point scale (0 = None, 10 = Maximum). Change from Baseline was calculated as the Week 12 and 24 values minus the Baseline values. The BDI indicates the degree of exertion, breathlessness, fatigue, or difficulty breathing after completion of the 6MWT. The lower values, 0 as the lowest, indicates no exertion, fatigue, or breathlessness felt, and 10 would be the maximum amount of exertion felt as assessed by each participant. The last observation carried forward method was used to impute missing values.|Baseline, Week 12 and Week 24|ITT Population.||scores on a scale||Standard Deviation|Mean
663179|NCT01808313|Secondary|Number of Participants With a Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 12 and 24|The WHO FC was determined by the investigator as follows: Class I- Participants with pulmonary hypertension (PH) but without resulting limitation of physical activity, II- Participants with PH resulting in slight limitation of physical activity, III- Participants with PH resulting in marked limitation of physical activity, IV- Participants with PH with inability to carry out any physical activity without symptoms. Changes from Baseline in functional class were summarized at Weeks 12 and 24. The number of participants improving by 2 classes, improving by 1 class, not changing, worsening by 1 class or worsening by 2 classes from Baseline at Weeks 12 and 24 were evaluated. The Baseline value was the last non-missing assessment value before treatment. Only participants with non-missing Baseline values and at least one non-missing post-Baseline value of the response variable were included. The last observation carried forward method was used to impute missing values.|Baseline, Week 12 and Week 24|ITT Population||Participants|||Number
663205|NCT01808261|Secondary|Number of Participants Experiencing Falls|The number of participants who experienced at least one fall between BL to Day 90 and BL to Day 180 is summarized.|BL (Day 1) Day 90 and Day 180|Safety population is defined as participants who had received at least one infusion of investigational product.||Participants|||Count of Participants
663181|NCT01808313|Primary|Change From Baseline in 6-minutes Walk Test (6MWT) at Week 12|The 6MWT measures the distance that a participant can walk in a period of 6 minutes. Change from Baseline was calculated as the Week 12 value minus the Baseline value. Baseline 6MWT comprised of an average of the last two consecutive measurements prior to dosing that varied by not greater than 10 percent (%). If only one measurement was available, that measurement was used as the Baseline value. The last observation carried forward method was used to impute missing values.|Baseline and Week 12|Intent-to-Treat (ITT) Population: all participants who received at least one dose of study medication and had an efficacy assessment performed both at Baseline and after administration of the study medication||Meters||Standard Deviation|Mean
663182|NCT01808261|Secondary|Antibodies Against GSK249320, Assessed Using Electrochemi-luminescent Assay (ECL) Assay|Blood samples were collected and the presence of antibodies against GSK249320 was assessed using ECL assays. Positive result indicated presence of antibodies and negative result indicated absence of antibodies. Confirmed samples with presence of antibodies were further characterized for neutralizing activity as binding antibody (BAb) and neutralising antibody (NAb) by a neutralization assay.By-visit sample sizes vary due to missing data or early termination of the study.|Day 1, Day 30, Day 180, EW visit and Follow-up visit|Safety Population. Only those participants with data available at the specified time points were analyzed.||Participants|||Count of Participants
663183|NCT01808261|Secondary|Volume of Distribution (V1 and V2) and Volume at Steady State (Vss) for GSK249320|Blood samples were collected for determination of plasma concentrations of GSK249320. V1, V2 and Vss were derived from the plasma concentration-time data. Analysis was performed for PK Population that comprised of all participants in the Safety Population who had at least one PK sample with a concentration above the non-quantifiable limit. Only participants in the GSK249320 15 mg/kg group were analyzed.|Up to Day 180|PK Population||milliliters/kilogram||Geometric Coefficient of Variation|Geometric Mean
663184|NCT01808261|Secondary|Clearance (CL) for GSK249320|Blood samples were collected for determination of plasma concentrations of GSK249320. CL was derived from the plasma concentration-time data. Analysis was performed for PK Population that comprised of all participants in the Safety Population who had at least one PK sample with a concentration above the non-quantifiable limit. Only participants in the GSK249320 15 mg/kg group were analyzed.|Up to Day 180|PK Population.||Milligrams/kilograms/hour||Geometric Coefficient of Variation|Geometric Mean
663185|NCT01808261|Secondary|Area Under the Concentration-time Curve From 0 to 5 Days [AUC(0-5d)] and Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time [AUC(0-inf)] for GSK249320|Blood samples were collected for determination of plasma concentrations of GSK249320. AUC (0-5d) and AUC (0-inf) were derived from the plasma concentration-time data. AUC(0-5d) is the model predicted AUC over the planned TAU of 5 days. Only participants in the GSK249320 15 mg/kg group were analyzed.|Pre-dose and post-dose up to Day 180|PK Population.||Milligrams/milliliter*hour||Geometric Coefficient of Variation|Geometric Mean
663186|NCT01808261|Secondary|PK as Measured by Plasma Decay Half-life (t1/2) GSK249320|Blood samples were collected for determination of plasma concentrations of GSK249320. Terminal phase half-life was derived from the plasma concentration-time data. Only participants in the GSK249320 15 mg/kg group were analyzed.|Up to Day 180|PK Population.||Days||Full Range|Median
663187|NCT01808261|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) GSK249320|Tmax is the time of the occurrence of Cmax. The Cmax is defined as the maximum observed concentration of GSK249320 obtained at the end of infusion post dose on day 6. Due to early termination of the study data for Tmax was not collected.|Pre-dose and post-dose up to Day 180|PK population. Due to early termination of the study, data for Tmax was not collected|||||
663188|NCT01808261|Secondary|Maximum Observed Plasma Concentration (Cmax) for GSK249320|Cmax is the maximum observed concentration of GSK249320 obtained at the end of infusion post dose on Day 6. Due to early termination of the study, this data was not collected.|Pre-dose and post-dose up to Day 180|The Pharmacokinetics (PK) population consisted of all participants in the Safety population who have at least one PK sample with a concentration above the non-quantifiable limit. Data not collected due to early termination of study.|||||
663189|NCT01808261|Secondary|Number of Participants With Suicidal Ideation Via Columbia Suicide Severity Rating Scale (CSSRS)|The C-SSRS is a clinician-rated scale that evaluates severity and change of suicidality by integrating both behavior and ideation. It has 3 sections, Suicidal Behavior (SB), Suicidal Ideation (SI) and Intensity of Ideation (II). For SB, participants (par) were scored non-suicidal:0, preparatory acts or behavior communicating ideation:1, aborted attempt:2, interrupted attempt:3 or actual attempt:4 (most severe). For SI, par were scored non-suicidal:0, wish to be dead:1, non-specific active suicidal thoughts:2, active suicidal ideation with associated thoughts of methods without intent:3, active suicidal ideation with some intent to act on suicidal thoughts without clear plan:4, active suicidal ideation with plan and intent:5 (most severe). II scale made of 5 questions measuring frequency, duration, controllability, deterrent and reasons; par received a separate score on most common ideation and on most severe. Total II score is obtained by adding scores from all 5 questions|Da y 1, Da y 6, Day 30, Day 60, Day 90 and Day 180|Safety Population. Number of participants with at least one on-treatment C-SSRS assessment were included.||Participants|||Count of Participants
663190|NCT01808261|Secondary|Change From BL in NIHSS Total Score|The NIHSS is a 15 item, standardized, disease-specific, deficit scale which measures neurological impairment (level of consciousness, eye movements, visual fields, facial symmetry, motor strength (arm and leg), coordination, sensation, language (aphasia and dysarthria), and neglect) and is used to quantify participant status by measuring the severity of the stroke as assessed by NIHSS certified study personnel. The total NIHSS score is calculated as the sum of responses to the 15 items. The total NIHSS score ranges from 0-42, with a higher score indicative of a more severe impairment. By-visit sample sizes vary due to missing data or early termination of the study. Change from BL was calculated as the individual post-Baseline value minus the BL value. BL was defined as the value at Day 1.|BL (Day 1), Day 30, Day 90 and Day 180|Safety Population. Only those participants with data available at the specified time points were analyzed.||Scores on a scale||Standard Deviation|Mean
663191|NCT01808261|Secondary|Change From Baseline in Hematology- Hematocrit|Hematocrit was measured at Baseline, Day 6, Day 30, Day 90 and Day 180. BL was the value obtained on Day 1. Change from BL was calculated as the individual post-Baseline value minus the BL value.By-visit sample sizes vary due to missing data or early termination of the study.|BL (Day 1), Day 6, Day 30, Day 90 and Day 180|Safety Population. Only those participants with data available at the specified time points were analyzed.||Ratio||Standard Deviation|Mean
663192|NCT01808261|Secondary|Change From BL in Hematology- Hemoglobin|Hemoglobin was measured at BL Day 6, Day 30, Day 90 and Day 180. BL was the value obtained on Day 1. Change from BL was calculated as the individual post-Baseline value minus the BL value. . By-visit sample sizes vary due to missing data or early termination of the study.|BL (Day 1), Day 6, Day 30, Day 90 and Day 180|Safety Population. Only those participants with data available at the specified time points were analyzed.||Grams per liter||Standard Deviation|Mean
663193|NCT01808261|Secondary|Change From BL in Eosinophils (EOS), Lymphocytes (LYM), Total Absolute Neutrophil Count (ANC), Platelet (PLT) Count, White Blood Cell (WBC) Count|EOS, LYM, Total ANC, PLT count and WBC count were measured at BL, Day 6, Day 30, Day 90 and Day 180. BL was the value obtained on Day 1. Change from BL was calculated as the individual post-Baseline value minus the BL value.By-visit sample sizes vary due to missing data or early termination of the study.|BL (Day 1), Day 6, Day 30, Day 90 and Day 180|Safety Population. Only those participants with data available at the specified time points were analyzed.||Giga (10^9 cells) per liter||Standard Deviation|Mean
663194|NCT01808261|Secondary|Change From BL in Clinical Chemistry- Direct Bilirubin, Total Bilirubin, Creatinine|Direct bilirubin, total bilirubin and creatinine were measured at BL, Day 6, Day 30, Day 90 and Day 180. BL was the value obtained on Day 1. Change from BL was calculated as the individual post-Baseline value minus the BL value. By-visit sample sizes vary due to missing data or early termination of the study.|BL (Day 1), Day 6, Day 30, Day 90 and Day 180|Safety Population. Only those participants with data available at the specified time points were analyzed.||Micromoles per liter||Standard Deviation|Mean
663195|NCT01808261|Secondary|Change From BL in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)|ALP, ALT and AST were measured at BL, Day 6, Day 30, Day 90 and Day 180. BL was the value obtained on Day 1. Change from BL was calculated as the individual post-Baseline value minus the BL value. By-visit sample sizes vary due to missing data or early termination of the study.|BL (Day 1), Day 6, Day 30, Day 90 and Day 180|Safety Population. Only those participants with data available at the specified time points were analyzed.||International units per liter||Standard Deviation|Mean
663196|NCT01808261|Secondary|Change From BL in Clinical Chemistry-urea/Blood Urea Nitrogen (BUN), Sodium (Na), Potassium (K), Glucose (Gluc), Chloride (Cl), Calcium (Ca)|Ca, Cl, Gluc, K, Na and BUN were measured at BL, Day 6, Day 30, Day 90 and Day 180. BL was the value obtained on Day 1. Change from BL was calculated as the individual post-Baseline value minus the BL value. By-visit sample sizes vary due to missing data or early termination of the study.|BL (Day 1), Day 6, Day 30, Day 90 and Day 180|Safety Population. Only those participants with data available at the specified time points were analyzed.||Millimoles per liter||Standard Deviation|Mean
663197|NCT01808261|Secondary|Change From BL in Clinical Chemistry- Albumin and Total Protein|ALB and TP were measured at BL, Day 6, Day 30, Day 90 and Day 180. Baseline was the value obtained on Day 1. Change from BL was calculated as the individual post-Baseline value minus the BL value. By-visit sample sizes vary due to missing data or early termination of the study.|BL (Day 1), Day 6, Day 30, Day 90 and Day 180|Safety Population. Only those participants with data available at the specified time points were analyzed.||Grams per liter||Standard Deviation|Mean
663198|NCT01808261|Secondary|Change From BL in ECG Parameters|A single 12-lead ECG was obtained at each time point and the following ECG intervals were determined: PR, QRS, QT, RR and corrected QT (QTc), QT interval corrected by Bazett's formula (QTcB), QT interval corrected by Fridericia's formula (QTcF). BL for ECG parameters was the value of Day 1. Change from BL was calculated as the individual post-Baseline value minus the BL value. By-visit sample sizes vary due to missing data or early termination of the study.|BL (Day 1), Day 6, Day 30 and EW visit|Safety Population. Only those participants with data available at the specified time points were analyzed.||Milliseconds||Standard Deviation|Mean
663199|NCT01808261|Secondary|Change From BL in ECG Parameter-Heart Rate|A single 12-lead ECG was obtained at each time point that measured heart rate. BL was the value obtained on Day 1. Change from BL was calculated as the individual post-Baseline value minus the BL value. By-visit sample sizes vary due to missing data or early termination of the study.|BL (Day 1) Day 6, Day 30 and EW visit|Safety Population. Only those participants with data available at the specified time points were analyzed.||Beats per minute||Standard Deviation|Mean
663200|NCT01808261|Secondary|Change From BL in Vitals Signs-Heart Rate|Safety was measured by monitoring vital signs including heart rate. The BL for heart rate was the value of pre-dose assessment on Day 1. Change from BL was calculated as the individual post-BL value minus the BL value. By-visit sample sizes vary due to missing data or early termination of the study. BL was defined as Day 1.|Day 1, Day 6, Day 180 and EW visit|Safety Population. Only those participants with data available at the specified time points were analyzed.||Beats per minute||Standard Deviation|Mean
663201|NCT01808261|Secondary|Change From BL in Vital Signs- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Safety was measured by monitoring vital signs including blood pressure. The BL for DBP and SBP was the value of pre-dose assessment on Day 1. Change from BL was calculated as the individual post-Baseline value minus the BL value. By-visit sample sizes vary due to missing data or early termination of the study.|BL (Day 1) , Day 6, Day 180 and early withdrawal (EW) visit|Safety Population. Only those participants with data available at the specified time points were analyzed.||Millimeters of mercury||Standard Deviation|Mean
663202|NCT01808261|Secondary|Number of Participants With Events Common to Stroke|Events common to stroke were those events that commonly occurred after a stroke and are generally associated with the underlying stroke or the progression of stroke. These included joint or soft tissue pain, bladder incontinence, depression/mood disorder, urinary tract infection, dysphagia, bowel incontinence, dysarthia, confusion, spasticity, limb edema, aspiration pneumonia, hemorrhagic transformation (symptomatic or asymptomatic), pressure ulcers, progression of stroke, malnutrition, deep vein thrombosis, brain herniation, pulmonary embolism, seizures, and falls.|From Day 1 until early withdrawal, death, Month 6/Day 180|Safety Population.||Participants|||Count of Participants
663203|NCT01808261|Secondary|Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs)|An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect or all events of possible drug-induced liver injury with hyperbilirubinaemia. Medical or scientific judgment is exercised in other situations.|Up to 14 months|Safety population.||Participants|||Count of Participants
663206|NCT01808261|Secondary|Change From BL in Dexterity as Measured by Box and Blocks Test|Dexterity is ability of person to use hands skillfully in performing a task. Box and Blocks test is an objective, gross manual dexterity test in individuals with upper limb impairments. Participants were asked to move small wooden blocks from one side of a partitioned box to other. The score was determined by number of blocks transferred within a 60 second time period. Both affected and unaffected arms were tested, starting with the unaffected arm. Change from BL was calculated as the individual post- BL value minus BL value. A higher number of displaced blocks indicated a better gross dexterity and a low number of displaced blocks indicated poor gross dexterity. It was analyzed using fixed effects for treatment, visit, treatment by visit interaction, sex, age, Baseline National Institute of Health stroke scale (NIHSS) total score, BL number of blocks transferred by the affected and unaffected arms, country and presence of concomitant medications that potentially impact recovery.|BL (Day 1), Month 1/Day 30, Month 2/Day 60, Month 3/Day 90 and Month 6/Day 180|PP Population.||Number of blocks||Standard Error|Least Squares Mean
663207|NCT01808261|Secondary|Number of Participants With Indicated Transition From One Gait Velocity Category to Another Category at the Indicated Time Points|Participants were categorized at each visit into the following gait velocity categories: 0 m/s, >0 to <0.4 m/s, >=0.4 m/s to 0.8 m/s and >0.8m/s. A distinction was made between participants who are too incapacitated to walk (i.e., gait velocity = 0m/s) and participants for whom the gait velocity assessment was not performed due to another reason (i.e., truly missing data). Participants were asked to walk at their usual or normal pace and using their normal assistive devices. Two trials of gait velocity were conducted at each time point. The number of participants transitioning from one gait velocity category to another category was assessed at each post-Baseline visit and was presented in terms of the following transition categories: worsened, no change, improved 1 level, improved 2 levels and improved 3 levels. By-visit sample sizes vary due to missing data or early termination of the study, missing data was not imputed.|BL (Day 1), Month 1/Day 30, Month 2/Day 60, Month 3/Day 90 and Month 6/Day 180.|PP Population consisted of all participants who were included in the ITT population and did not violate protocol with regards to inclusion/exclusion criteria, unblinding, investigational product administration and gait velocity assessments. Only participants with data available at the specified time points were analyzed.||Participants|||Count of Participants
663208|NCT01808261|Secondary|Mean Change From BL to Month 6/ Day 180 in Gait Velocity|Gait is the way or manner in which a person walks. Gait velocity (walking speed) is an objective, quantitative measure of lower extremity motor recovery in individuals who have had a stroke. Participants were asked to walk at their usual pace over a level, indoor 10 m distance and were allowed to use their normal assistive devices. The time (s) taken by the participants to travel the 10 m distance was recorded. Gait velocity (m/s) as assessed by study personnel was derived as: 10 divided by time to walk 10 m. Two trials of gait velocity were conducted at each time point. Change from BL was calculated as the mean Month 3/Day 90 value minus the mean BL value. BL was defined as Day 1. The measure type displayed are posterior means.|BL (Day 1) and Month 6/Day 180|ITT Population.||m/s||Standard Deviation|Mean
663209|NCT01808261|Primary|Mean Change From Baseline (BL) to Month 3/ Day 90 in Gait Velocity|Gait is the way or manner in which a person walks. Gait velocity (walking speed) is an objective, quantitative measure of lower extremity motor recovery in individuals who have had a stroke. Participants were asked to walk at their usual pace over a level, indoor 10 meter (m) distance and were allowed to use their normal assistive devices. The time (seconds[s]) taken by the participants to travel the 10 m distance was recorded. Gait velocity (m/s) as assessed by study personnel was derived as: 10 divided by time to walk 10 m. Two trials of gait velocity were conducted at each time point. Change from BL was calculated as the mean Month 3/Day 90 value minus the mean BL value. BL was defined as Day 1. The measure type displayed are posterior means.|BL (Day 1) and Month 3/Day 90|Intent-To-Treat (ITT) population comprised of participants who received at least 1 infusion of investigational product and had at least 1 post-Baseline efficacy assessment.||m/s||Standard Deviation|Mean
663210|NCT01808248|Secondary|Percentage of Participants Experiencing Viral Relapse|Viral relapse was defined as having HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at the end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement.|Up to Posttreatment Week 24|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants|||Number
663211|NCT01808248|Secondary|Percentage of Participants Experiencing On-treatment Virologic Failure|"On-treatment virologic failure was defined as:
Viral breakthrough: HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or
Viral rebound: > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or
Nonresponse: HCV RNA persistently ≥ LLOQ through 8 weeks of treatment"|Up to 12 weeks|Full Analysis Set||percentage of participants|||Number
663212|NCT01808248|Secondary|Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set||percentage of participants|||Number
663213|NCT01808248|Primary|Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)|The percentage of participants discontinuing any study drug due to an adverse event was summarized.|Up to 12 weeks|Safety Analysis Set: participants enrolled and received at least 1 dose of study drug||percentage of participants|||Number
663214|NCT01808248|Primary|Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, < 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants with genotype 2 or 3 HCV infection who were enrolled and received at least 1 dose of study drug||percentage of participants|||Number
663215|NCT01808209|Primary|Wettability|Participant rating for surface wettability. Collected at 1 week. Tear film analysis in seconds.|1 Week|All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.||seconds|Participants|Standard Deviation|Mean
664001|NCT01792635|Primary|Rate of Appearance of Glucose (Ra) in Part A|Rate of appearance of glucose (Ra) in fasting state and during insulin infusions (Step 1 and Step 2).|1 day|All participants randomized and who had at least one euglycemic hyperinsulinemic clamp.||mg/kg BW/min||Full Range|Mean
663231|NCT01808209|Primary|Dryness|Participant rating for dryness. Collected at 1 week. (0-100, 0= very uncomfortable and 100= extreme comfort/cannot feel them at all).|1 Week|All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.||units on a scale||Standard Deviation|Mean
663232|NCT01808209|Secondary|Blood Vessel Coverage|Assessment of ocular health. Collected at baseline after removal of lenses. Percent of blood vessel coverage.|Baseline|Prior to randomization||percentage of blood vessel coverage|Participants|Standard Deviation|Mean
663233|NCT01808209|Primary|Dryness|Participant rating of lens dryness. Collected at baseline for habitual pair. (0-100; 0=very uncomfortable, 100=extreme comfort/ cannot feel them at all)|Baseline|All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.||units on a scale||Standard Deviation|Mean
663234|NCT01808209|Primary|Comfort|Participant rating for comfort. Collected at 1 week. (0-100, 0= very uncomfortable and 100= extreme comfort/cannot feel them at all).|1 Week|All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.||units on a scale||Standard Deviation|Mean
663235|NCT01808209|Primary|Comfort|Participant rating of lens comfort. Collected at baseline for habitual pair. (0-100; 0=very uncomfortable,100=extreme comfort / cannot feel them at all)|Baseline|All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.||units on a scale||Standard Deviation|Mean
663236|NCT01808209|Primary|Handling|Participant rating for lens handling. Collected at 1 week. (Insertion: 0-100, 0= could not get it in and 100= went in without a problem. Removal: 0= could not get it out and 100= came out without a problem. Blister: 0=impossible and 100=came out extremely easily).|1 Week|All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.||units on a scale||Standard Deviation|Mean
663237|NCT01808209|Primary|Daily and Comfortable Wearing Time|Participant rating of lens Daily and Comfortable Wearing Time. Collected at 1 week wear for each lens.(The hours of average comfortable wearing time and average daily wearing time.)|1 week|All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.||hours||Standard Deviation|Mean
663238|NCT01808209|Primary|Daily and Comfortable Wearing Time|Participant rating of lens Daily and Comfortable Wearing Time. Collected at baseline for all habitual lenses.(The hours of average comfortable wearing time and average daily wearing time.)|Baseline|||hours||Standard Deviation|Mean
663239|NCT01808092|Secondary|The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in the Clinically Evaluable at Test-of-cure Analysis Set|The number of patients discharged from hospital in the clinically evaluable at test-of-cure analysis set.|up to 25 days from randomization|The clinically evaluable (CE) analysis set included all patients in the clinical modified intent-to-treat (cMITT) analysis set who met the stringent criteria for clinical evaluation described in the protocol regarding dosing, prior and concomitant medication, evaluation, etc.||participants|||Number
663240|NCT01808092|Secondary|The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in the Clinically Modified Intent-to-treat Analysis Set|The number of patients discharged from hospital in the clinically modified intent-to-treat analysis set.|up to 25 days from randomization|The clinical modified intent-to-treat (cMITT) included all patients who met the minimum disease criteria and received any amount of study treatment, and had either no baseline pathogens or at least one study-qualifying Gram-negative baseline pathogen.||participants|||Number
663241|NCT01808092|Secondary|The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set|The number of patients discharged from hospital in microbiologically modified intent-to-treat analysis set.|up to 25 days from randomization|The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen.||participants|||Number
663242|NCT01808092|Secondary|The Number of Patients With Death Due to Any Cause (All-cause Mortality) in the Clinically Evaluable at Test-of-cure Analysis Set at Day 28|The number of patients with death due to any cause (all-cause mortality) in the clinically evaluable at test-of-cure analysis set at day 28.|at Day 28 from randomization|The clinically evaluable (CE) analysis set included all patients in the clinical modified intent-to-treat (cMITT) analysis set who met the stringent criteria for clinical evaluation described in the protocol regarding dosing, prior and concomitant medication, evaluation, etc.||participants|||Number
663243|NCT01808092|Secondary|The Number of Patients With Death Due to Any Cause (All-cause Mortality) in Clinically Modified Intent-to-treat Analysis Set at Day 28|The number of patients with death due to any cause (all-cause mortality) in clinically modified intent-to-treat analysis set at day 28.|at Day 28 from randomization|The clinical modified intent-to-treat (cMITT) included all patients who met the minimum disease criteria and received any amount of study treatment, and had either no baseline pathogens or at least one study-qualifying Gram-negative baseline pathogen.||participants|||Number
663244|NCT01808092|Secondary|The Number of Patients With Death Due to Any Cause (All-cause Mortality) in Microbiologically Modified Intent-to-treat Analysis Set at Day 28|The number of patients with death due to any cause (all-cause mortality) in microbiologically modified intent-to-treat analysis set at day 28.|at Day 28 from randomization|The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen.||participants|||Number
663245|NCT01808092|Secondary|The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in the Clinically Evaluable at Test-of-cure Analysis Set|The number of patients with death due to any cause (all-cause mortality) in the clinically evaluable at test-of-cure analysis set.|At the test-of-cure (TOC) visit (Day 21 to 25)|The clinically evaluable (CE) analysis set included all patients in the clinical modified intent-to-treat (cMITT) analysis set who met the stringent criteria for clinical evaluation described in the protocol regarding dosing, prior and concomitant medication, evaluation, etc.||participants|||Number
663246|NCT01808092|Secondary|The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in Clinically Modified Intent-to-treat Analysis Set at Test-of-cure Visit|The number of patients with death due to any cause (all-cause mortality) in clinically modified intent-to-treat analysis set at test-of-cure visit.|At the test-of-cure (TOC) visit (Day 21 to 25)|The clinical modified intent-to-treat (cMITT) included all patients who met the minimum disease criteria and received any amount of study treatment, and had either no baseline pathogens or at least one study-qualifying Gram-negative baseline pathogen.||participants|||Number
663247|NCT01808092|Secondary|The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit|The number of patients with death due to any cause (all-cause mortality) in microbiologically modified intent-to-treat analysis set at test-of-cure visit.|At the test-of-cure (TOC) visit (Day 21 to 25)|The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen.||participants|||Number
663248|NCT01808092|Secondary|The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set|The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.|At the test-of-cure (TOC) visit (Day 21 to 25)|Microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem). Patients infected with ceftazidime-resistant Gram negative pathogens at TOC (pathogens in ≥5 patients)||participants with favorable responses|||Number
663249|NCT01808092|Secondary|The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set|The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.|At the test-of-cure (TOC) visit (Day 21 to 25)|The extended-ME (EME) analysis set defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents. Patients infected with ceftazidime-resistant Gram negative pathogens at TOC (pathogens in ≥5 patients)||participants with favorable responses|||Number
663250|NCT01808092|Secondary|The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit|The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.|At the test-of-cure (TOC) visit (Day 21 to 25)|The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen. Patients infected with ceftazidime-resistant Gram negative pathogens at TOC (pathogens in ≥5 patients)||participants with favorable responses|||Number
663251|NCT01808092|Secondary|The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set|The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.|Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.|Microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem). Patients infected with ceftazidime-resistant Gram negative pathogens at EOT (pathogens in ≥5 patients)||participants with favorable responses|||Number
663252|NCT01808092|Secondary|The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set|The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.|Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.|The extended-ME (EME) analysis set defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents. Patients infected with ceftazidime-resistant Gram negative pathogens at EOT (pathogens in ≥5 patients)||participants with favorable responses|||Number
663253|NCT01808092|Secondary|The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit|The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.|Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.|The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen. Patients infected with ceftazidime-resistant Gram negative pathogens at EOT (pathogens in ≥5 patients)||participants with favorable responses|||Number
663286|NCT01808092|Primary|The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Clinically Evaluable at TOC Analysis Set (Co-primary Analyses)|The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive.|At the test-of-cure (TOC) visit (Day 21 to 25)|The clinically evaluable (CE) analysis set included all patients in the clinical modified intent-to-treat (cMITT) analysis set who met the stringent criteria for clinical evaluation described in the protocol regarding dosing, prior and concomitant medication, evaluation, etc.||participants|||Number
663254|NCT01808092|Secondary|Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure."|At the test-of-cure (TOC) visit (Day 21 to 25)|The microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem). Patients infected with ceftazidime-resistant Gram negative pathogens at TOC||participants|||Number
663255|NCT01808092|Secondary|Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure."|At the test-of-cure (TOC) visit (Day 21 to 25)|The extended-ME (EME) analysis set defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents. Patients infected with ceftazidime-resistant Gram negative pathogens at TOC||participants|||Number
663256|NCT01808092|Secondary|Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure."|At the test-of-cure (TOC) visit (Day 21 to 25)|The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen. Patients infected with ceftazidime-resistant Gram negative pathogens at TOC||participants|||Number
663257|NCT01808092|Secondary|Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure."|Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.|The microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem). Patients infected with ceftazidime-resistant Gram negative pathogens at EOT||participants|||Number
663258|NCT01808092|Secondary|Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure."|Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.|The extended-ME (EME) analysis set defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents. Patients infected with ceftazidime-resistant Gram negative pathogens at EOT||participants|||Number
663259|NCT01808092|Secondary|Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure."|Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.|The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen. Patients infected with ceftazidime-resistant Gram negative pathogens at EOT||participants|||Number
663260|NCT01808092|Secondary|The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set|The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive.|At the test-of-cure (TOC) visit (Day 21 to 25)|The microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem). (pathogens in ≥5 patients)||participants|||Number
663319|NCT01807923|Secondary|Absolute Change From Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score at Week 24|The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), the scaled score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.|Baseline, Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.||units on a scale||Standard Error|Least Squares Mean
663261|NCT01808092|Secondary|The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Clinically Evaluable at Test-of-cure Analysis Set|The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive.|At the test-of-cure (TOC) visit (Day 21 to 25)|The clinically evaluable (CE) analysis set included all patients in the clinical modified intent-to-treat (cMITT) analysis set who met the stringent criteria for clinical evaluation described in the protocol regarding dosing, prior and concomitant medication, evaluation, etc. (pathogens in ≥5 patients)||participants|||Number
663262|NCT01808092|Secondary|The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Clinically Modified Intent-to-treat Analysis Set at Test-of-cure Visit|The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive.|At the test-of-cure (TOC) visit (Day 21 to 25)|The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen. (pathogens in ≥5 patients)||participants|||Number
663263|NCT01808092|Secondary|The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set|The number of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment.|Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.|The microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem). (pathogens in ≥5 patients)||participants|||Number
663264|NCT01808092|Secondary|The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Evaluable at End of Treatment Analysis Set|The number of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment.|Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.|The clinically evaluable (CE) analysis set included all patients in the clinical modified intent-to-treat (cMITT) analysis set who met the stringent criteria for clinical evaluation described in the protocol regarding dosing, prior and concomitant medication, evaluation, etc. (pathogens in ≥5 patients)||participants|||Number
663265|NCT01808092|Secondary|The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Modified Intent-to-treat Analysis Set at End of Treatment Visit|The number of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment.|Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.|The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen. (pathogens in ≥5 patients)||participants|||Number
663266|NCT01808092|Secondary|The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set|The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.|At the test-of-cure (TOC) visit (Day 21 to 25)|The microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem). (pathogens in ≥10 patients)||participants with favorable responses|||Number
663267|NCT01808092|Secondary|The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set|The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.|At the test-of-cure (TOC) visit (Day 21 to 25)|The extended-ME (EME) analysis set defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents. (pathogens in ≥10 patients)||participants with favorable responses|||Number
663268|NCT01808092|Secondary|The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit|The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.|At the test-of-cure (TOC) visit (Day 21 to 25)|The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen. (pathogens in ≥10 patients)||participants with favorable responses|||Number
663370|NCT01807000|Primary|Maximum Plasma Concentration (Cmax) of Radiolabelled Prucalopride Succinate|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administered.|Over 240 hours post-dose|Pharmacokinetic Analysis Set||ng/ml||Standard Deviation|Mean
663269|NCT01808092|Secondary|The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set|The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.|Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.|The microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem). (pathogens in ≥10 patients)||participants with favorable responses|||Number
663270|NCT01808092|Secondary|The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set|The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.|Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.|The extended-ME (EME) analysis set defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents. (pathogens in ≥10 patients)||participants with favorable responses|||Number
663271|NCT01808092|Secondary|The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit|The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.|Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.|The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen. (pathogens in ≥10 patients)||participants with favorable responses|||Number
663272|NCT01808092|Secondary|The Number of Patients With a Favorable Per-patient Microbiologic Response at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure."|At the test-of-cure (TOC) visit (Day 21 to 25)|The microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem).||participants|||Number
663273|NCT01808092|Secondary|The Number of Patients With a Favorable Per-patient Microbiologic Response at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure."|Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.|The microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem).||participants|||Number
663274|NCT01808092|Secondary|The Number of Patients With a Favorable Per-patient Microbiologic Response at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure."|At the test-of-cure (TOC) visit (Day 21 to 25)|The extended-ME (EME) analysis set defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents.||participants|||Number
663275|NCT01808092|Secondary|The Number of Patients With a Favorable Per-patient Microbiologic Response at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure."|Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.|The extended-ME (EME) analysis set defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents.||participants|||Number
663276|NCT01808092|Secondary|The Number of Patients With a Favorable Per-patient Microbiologic Response at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure."|At the test-of-cure (TOC) visit (Day 21 to 25)|The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen.||participants|||Number
663320|NCT01807923|Secondary|Absolute Change From Baseline in Body Mass Index (BMI) at Week 24|BMI was defined as weight in kilogram (kg) divided by height*height in square meter (m^2).|Baseline, Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.||kilogram per square meter (kg/m^2)||Standard Error|Least Squares Mean
663277|NCT01808092|Secondary|The Number of Patients With a Favorable Per-patient Microbiologic Response at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure."|Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.|The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen.||participants|||Number
663278|NCT01808092|Secondary|The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Microbiologically Evaluable Analysis Set|The number of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment.|Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.|The microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem).||participants|||Number
663279|NCT01808092|Secondary|The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable Analysis Set|The number of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment.|Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.|The extended-ME (EME) analysis set defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents.||participants|||Number
663280|NCT01808092|Secondary|The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Clinically Evaluable Analysis Set|The number of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment.|Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.|The clinically evaluable (CE) analysis set included all patients in the clinical modified intent-to-treat (cMITT) analysis set who met the stringent criteria for clinical evaluation described in the protocol regarding dosing, prior and concomitant medication, evaluation, etc.||participants|||Number
663281|NCT01808092|Secondary|The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Clinically Modified Intent-to-treat Analysis Set|The number of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment.|Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.|The clinical modified intent-to-treat (cMITT) included all patients who met the minimum disease criteria and received any amount of study treatment, and had either no baseline pathogens or at least one study-qualifying Gram-negative baseline pathogen.||participants|||Number
663282|NCT01808092|Secondary|The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set|The number of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment.|Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.|The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen.||participants|||Number
663283|NCT01808092|Secondary|The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Microbiologically Evaluable Analysis Set|The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive.|At the test-of-cure (TOC) visit (Day 21 to 25)|The microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem).||participants|||Number
663284|NCT01808092|Secondary|The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Extended Microbiologically Evaluable Analysis Set|The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive.|At the test-of-cure (TOC) visit (Day 21 to 25)|The extended-ME (EME) analysis set defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents.||participants|||Number
663285|NCT01808092|Secondary|The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Microbiologically Modified Intent-to-treat Analysis Set|The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive.|At the test-of-cure (TOC) visit (Day 21 to 25)|The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen.||participants|||Number
663287|NCT01808092|Primary|The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Clinically Modified Intent-to-treat Analysis Set (Co-primary Analyses)|The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive.|At the test-of-cure (TOC) visit (Day 21 to 25)|The clinical modified intent-to-treat (cMITT) included all patients who met the minimum disease criteria and received any amount of study treatment, and had either no baseline pathogens or at least one study-qualifying Gram-negative baseline pathogen.||participants|||Number
663288|NCT01808066|Other Pre-specified|Post Interview With Teachers to Qualitatively Assess Interest in Using the Game With Students and Any Improvements to be Made|Researchers will ask teachers for qualitative feedback once participants have completed game play about interest in using the game and any improvements to be made.|Day 21||||||
663289|NCT01808066|Other Pre-specified|Post Interview With Participants to Qualitatively Identify Themes of Interest and Quality of Life Effects|After playing game for three weeks, researchers will interview participants about their interest in the game and changes in quality of life (no forms).|Day 21||||||
663290|NCT01808066|Other Pre-specified|Pre Interview With Teachers to Qualitatively Identify Themes of Motivation and Interest|Researchers will conduct interviews with teachers and collect all notes/journals recorded. Specific questions will be asked about their perception of participant's attention, interest and motivation to play the game. Themes of the answers will be identified by researchers as a qualitative measure of interest.|Day 1||||||
663291|NCT01808066|Secondary|Pre Interview With Participants to Qualitatively Identify Interest and Motivation|Researchers will conduct interviews with players and collect all notes/journals recorded. Specific questions will be asked about their perception of their attention, interest and motivation to play the game. Themes of the answers will be identified by researchers as a qualitative measure of interest.|Day 1||||||
663292|NCT01808066|Primary|Number of Participants With an Increase/Improvement in Focusing|Researchers will observe and record data during the first play session. Over the three weeks, teachers/support staff will be asked to observe players each day and record their observations as needed in a journal. These observations will measure their improvement in their ability to focus by assessing their engagement, time played, frequency of play, ability to complete a session and ability to start and finish a session. At the end of three weeks, researchers will attend the final play session and record observations in writing.|3 weeks|||participants|||Number
663293|NCT01807949|Secondary|Pre-dose Concentration (Ctrough), Average Pre-dose Concentration (Ctrough,Avg), 3 to 6 Hours Post-dose Concentration (C3-6h), and Average 3 to 6 Hours Post-dose Concentration (C3-6h,Avg)|Ctrough, Ctrough,avg, C3-6h, and C3-6h,avg for lumacaftor, M28 lumacaftor (lumacaftor metabolite), ivacaftor, M1 ivacaftor (ivacaftor metabolite), and M6 ivacaftor (ivacaftor metabolite) were calculated. C3-6h,avg is average of individual 3 to 6 hours post-dose observed concentrations across Day 15, and Weeks 4 and 8 and Ctrough,avg is average of individual pre-dose observed concentrations across Weeks 4, 8, and 16. This outcome was not planned to be assessed in Placebo arm.|For C3-6h: 3 to 6 hours after morning dose on Day 1 and 15, Week 4 and 8; For C3-6h,avg 3 to 6 hours after morning dose on Day 15, Week 4 and 8; For Ctrough and Ctrough,avg: before morning dose on Week 4, 8, and 16|Pharmacokinetic (PK) population included all randomized participants who received at least one dose of study drug and had a PK assessment. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure and “n” signifies participants evaluable for specified category for each arm, respectively.||microgram per milliliter (mcg/mL)||Standard Deviation|Mean
663294|NCT01807949|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Treatment-Emergent Serious Adverse Events (SAEs)|AE: any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. AE includes serious as well as Non-serious AEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Any AE that increased in severity or that was newly developed at or after the initial dosing of study drug to 28 days after the last dose of study drug is considered treatment-emergent.|up to Week 28|Safety Set (SS) included all randomized participants who received any amount of study drug. Participants were analyzed as per actual treatment received.||participants|||Number
663295|NCT01807949|Secondary|Absolute Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Domain Scores at Week 24|The TSQM is a 14-item self-administered questionnaire which measures participants’ experiences with their medication on four dimensions: effectiveness, side effects, convenience and global satisfaction. For each dimension, responses are added and transformed to a scale from 0 to 100, where higher scores indicate greater satisfaction.|Baseline, Week 24|"FAS. Here, n signifies participants who were evaluable for specified category for each arm, respectively."||units on a scale||Standard Error|Least Squares Mean
663296|NCT01807949|Secondary|Absolute Change From Baseline in EQ-5D-3L VAS Score at Week 24|The EQ-5D-3L VAS records the participant’s self-rated health on a vertical, visual analogue scale where the best state a participant can imagine is marked 100 and the worst state a participant can imagine is marked 0, higher scores indicates a better health state.|Baseline, Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.||units on a scale||Standard Error|Least Squares Mean
663321|NCT01807923|Secondary|Relative Change From Baseline in Percent Predicted FEV1 at Week 24|Assessed as the average treatment effect at Week 16 and at Week 24. FEV1 and percent predicted FEV1 are defined in Outcome Measure (OM) 1.|Baseline, Week 16 and 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.||percent change||Standard Error|Least Squares Mean
663297|NCT01807949|Secondary|Absolute Change From Baseline in Euro Quality of Life Scale (EuroQol) 5-Dimension-3 Level (EQ-5D-3L) Index Score at Week 24|EQ-5D-3L: participant rated questionnaire to assess health-related quality of life. It consists of EQ-5D descriptive system and EQ-5D Visual Analog Scale (VAS). EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems (1), some problems (2), and extreme problems (3). The 5 dimensional 3-level systems are converted into a single index utility score. Values for theoretically possible health states are calculated using a regression model and weighted according to the social preferences of the Unites States (US) general population. For this population, the possible EQ-5D-3L index scores ranges from -0.11 (that is, 3 for all 5 dimensions) to 1.0 (that is, 1 for all 5 dimensions), where higher scores indicate a better health state.|Baseline, Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.||units on a scale||Standard Error|Least Squares Mean
663298|NCT01807949|Secondary|Percentage of Participants With At Least 1 Pulmonary Exacerbation Event||through Week 24|FAS.||percentage of participants|||Number
663299|NCT01807949|Secondary|Time-to-First Pulmonary Exacerbation|Time to first pulmonary exacerbation was assessed using Cox Regression method. For participants who completed 24 weeks of treatment, participants without a pulmonary exacerbation before treatment completion were considered censored at the time of treatment completion or at the Week 24 Visit (whichever occurred last). For participants who prematurely discontinued study treatment, participants without a pulmonary exacerbation through the Week 24 Visit were considered censored at the time of the Week 24 Visit.|through Week 24|FAS.||days||Full Range|Median
663300|NCT01807949|Secondary|Absolute Change From Baseline in BMI-for-age Z-score at Week 24|Z-Score is a statistical measure to evaluate how a single data point compares to a standard. It describes whether a mean was above or below the standard and how unusual the measurement is with range from -infinity to +infinity; 0: same mean, >0: a greater mean, and <0: a lesser mean than the standard. BMI-for-age z-score was calculated by using centers for disease control and prevention (CDC) growth charts for the pediatric population.|Baseline, Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Only participants who were <20 years of age were analyzed.||z-score||Standard Error|Least Squares Mean
663301|NCT01807949|Secondary|Absolute Change From Baseline in Weight at Week 24||Baseline, Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.||kilograms (kg)||Standard Error|Least Squares Mean
663302|NCT01807949|Secondary|Number of Pulmonary Exacerbation Events|The total number of days on study is equal to the Week 24 date or the last dose date (whichever occurred last) minus the first dose date plus 1. The total number of years (48 weeks) on study is equal to the number of days on study divided by 336. Pulmonary exacerbation events per year (48 weeks) are reported.|through Week 24|FAS.||pulmonary exacerbation events per year|||Number
663303|NCT01807949|Secondary|Percentage of Participants With Response Based on Percent Predicted FEV1|A participant was considered as a responder if the participant had >=5% increase from baseline in average percent predicted FEV1 at Week 16 and at Week 24 (relative change). FEV1 and percent predicted FEV1 are defined in OM 1. A participant with a missing average relative change from baseline in percent predicted FEV1 at Week 16 and at Week 24 was considered as a non-responder.|Week 16 and 24|FAS.||percentage of participants|||Number
663304|NCT01807949|Secondary|Absolute Change From Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score at Week 24|The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), the scaled score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.|Baseline, Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.||units on a scale||Standard Error|Least Squares Mean
663305|NCT01807949|Secondary|Absolute Change From Baseline in Body Mass Index (BMI) at Week 24|BMI was defined as weight in kilogram (kg) divided by height*height in square meter (m^2).|Baseline, Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.||kilogram per square meter (kg/m^2)||Standard Error|Least Squares Mean
663306|NCT01807949|Secondary|Relative Change From Baseline in Percent Predicted FEV1 at Week 24|Assessed as the average treatment effect at Week 16 and at Week 24. FEV1 and percent predicted FEV1 are defined in Outcome Measure (OM) 1.|Baseline, Week 16 and 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.||percent change||Standard Error|Least Squares Mean
663307|NCT01807949|Primary|Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Week 24|Absolute change from baseline at week 24 was assessed as the average treatment effect at Week 16 and at Week 24. FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, race, and height). The Hankinson standard was used for male participants 18 years and older and female participants 16 years and older. The Wang standard was used for male participants aged 12 to 17 years and for female participants aged 12 to 15 years.|Baseline, Week 16 and 24|Full Analysis Set (FAS) included all randomized participants who received any amount of study drug. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.||percent predicted of FEV1||Standard Error|Least Squares Mean
663322|NCT01807923|Primary|Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Week 24|Absolute change from baseline at Week 24 was assessed as the average treatment effect at Week 16 and at Week 24. FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, race, and height). The Hankinson standard was used for male participants 18 years and older and female participants 16 years and older. The Wang standard was used for male participants aged 12 to 17 years and for female participants aged 12 to 15 years.|Baseline, Week 16 and 24|Full Analysis Set (FAS) included all randomized participants who received any amount of study drug. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.||percent predicted of FEV1||Standard Error|Least Squares Mean
663308|NCT01807923|Secondary|Pre-dose Concentration (Ctrough), Average Pre-dose Concentration (Ctrough,Avg), 3 to 6 Hours Post-dose Concentration (C3-6h), and Average 3 to 6 Hours Post-dose Concentration (C3-6h,Avg)|Ctrough, Ctrough, avg, C3-6h, and C3-6h, avg for lumacaftor, M28 lumacaftor (lumacaftor metabolite), ivacaftor, M1 ivacaftor (ivacaftor metabolite), and M6 ivacaftor (ivacaftor metabolite) were calculated. C3-6h,ave is average of individual 3 to 6 hours post-dose observed concentrations across Day 15, and Weeks 4 and 8 and Ctrough, ave is average of individual pre-dose observed concentrations across Weeks 4, 8, and 16. This outcome was not planned to be assessed in Placebo arm.|For C3-6h: 3 to 6 hours after morning dose on Day 1 and 15, Week 4 and 8; For C3-6h,avg 3 to 6 hours after morning dose on Day 15, Week 4 and 8; For Ctrough and Ctrough,avg: before morning dose on Week 4, 8, and 16|Pharmacokinetic (PK) population included all randomized participants who received at least one dose of study drug and had a PK assessment. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure and “n” signifies participants evaluable for specified category for each arm, respectively.||microgram per milliliter (mcg/mL)||Standard Deviation|Mean
663309|NCT01807923|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Treatment-Emergent Adverse Events (SAEs)|AE: any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. AE includes serious as well as Nonserious AEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Any AE that increased in severity or that was newly developed at or after the initial dosing of study drug to 28 days after the last dose of study drug is considered treatment-emergent.|up to Week 28|Safety Set (SS) included all randomized participants who received any amount of study drug.||participants|||Number
663310|NCT01807923|Secondary|Absolute Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Domain Scores at Week 24|The TSQM is a 14-item self-administered questionnaire which measures participants’ experiences with their medication on four dimensions: effectiveness, side effects, convenience and global satisfaction. For each dimension, responses are added and transformed to a scale from 0 to 100, where higher scores indicate greater satisfaction.|Baseline, Week 24|"FAS. Here, n signifies participants who were evaluable for specified category for each arm, respectively."||units on a scale||Standard Error|Least Squares Mean
663311|NCT01807923|Secondary|Absolute Change From Baseline in EQ-5D-3L VAS Score at Week 24|The EQ-5D-3L VAS records the participant’s self-rated health on a vertical, visual analogue scale where the best state a participant can imagine is marked 100 and the worst state a participant can imagine is marked 0, higher scores indicates a better health state.|Baseline, Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.||units on a scale||Standard Error|Least Squares Mean
663312|NCT01807923|Secondary|Absolute Change From Baseline in Euro Quality of Life Scale (EuroQol) 5-Dimension-3 Level (EQ-5D-3L) Index Score at Week 24|EQ-5D-3L: participant rated questionnaire to assess health-related quality of life. It consists of EQ-5D descriptive system and EQ-5D Visual Analog Scale (VAS). EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems (1), some problems (2), and extreme problems (3). The 5 dimensional 3-level systems are converted into a single index utility score. Values for theoretically possible health states are calculated using a regression model and weighted according to the social preferences of the Unites States (US) general population. For this population, the possible EQ-5D-3L index scores ranges from -0.11 (that is, 3 for all 5 dimensions) to 1.0 (that is, 1 for all 5 dimensions), where higher scores indicate a better health state.|Baseline, Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.||units on a scale||Standard Error|Least Squares Mean
663313|NCT01807923|Secondary|Percentage of Participants With At Least 1 Pulmonary Exacerbation Event||through Week 24|FAS.||percentage of participants|||Number
663314|NCT01807923|Secondary|Time-to-First Pulmonary Exacerbation|Time to first pulmonary exacerbation was assessed using Cox Regression. For participants who completed 24 weeks of treatment, participants without a pulmonary exacerbation before treatment completion were considered censored at the time of treatment completion or at the Week 24 Visit (whichever occurred last). For participants who prematurely discontinued study treatment, participants without a pulmonary exacerbation through the Week 24 Visit were considered censored at the time of the Week 24 Visit.|through Week 24|FAS.||days||Full Range|Median
663315|NCT01807923|Secondary|Absolute Change From Baseline in BMI-for-age Z-score at Week 24|Z-Score is a statistical measure to evaluate how a single data point compares to a standard. It describes whether a mean was above or below the standard and how unusual the measurement is with range from –infinity to + infinity; 0: same mean, >0: a greater mean, and <0: a lesser mean than the standard. BMI-for-age z-score was calculated by using Centers for Disease Control and Prevention (CDC) growth charts for the pediatric population.|Baseline, Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Only participants who were <20 years of age were analyzed.||z-score||Standard Error|Least Squares Mean
663316|NCT01807923|Secondary|Absolute Change From Baseline in Weight at Week 24||Baseline, Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.||kilograms (kg)||Standard Error|Least Squares Mean
663317|NCT01807923|Secondary|Number of Pulmonary Exacerbation Events|The total number of days on study is equal to the Week 24 date or the last dose date (whichever occurred last) minus the first dose date plus 1. The total number of years (48 weeks) on study is equal to the number of days on study divided by 336. Pulmonary exacerbation events per year (48 weeks) are reported.|through Week 24|FAS.||pulmonary exacerbation events per year|||Number
663318|NCT01807923|Secondary|Percentage of Participants With Response Based on Percent Predicted FEV1|A participant was considered as a responder if the participant had >=5% increase from baseline in average percent predicted FEV1 at Week 16 and at Week 24 (relative change). FEV1 and percent predicted FEV1 are defined in OM 1. A participant with a missing average relative change from baseline in percent predicted FEV1 at Week 16 and at Week 24 was considered as a non-responder.|Week 16 and 24|FAS.||percentage of participants|||Number
663326|NCT01807624|Secondary|SpO2 Decrease of > 5% on 2 Consecutive Measurements After Administration of Study Medication||0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray|||participants|||Number
663327|NCT01807624|Secondary|SpO2 Increase of > 5% on 2 Consecutive Measurements After Administration of Study Medication||0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray|||participants|||Number
663328|NCT01807624|Secondary|Decrease in Pulse Rate > 20 Bpm on 2 Consecutive Measurements After Administration of Study Medication||0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray|||participants|||Number
663329|NCT01807624|Secondary|Increase in Pulse Rate > 20 Bpm on 2 Consecutive Measurements After Administration of Study Medication||0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray|||participants|||Number
663330|NCT01807624|Secondary|Decrease in DBP > 20 mmHg on 2 Consecutive Measurements After Administration of Study Medication||0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray|||participants|||Number
663331|NCT01807624|Secondary|Increase in DBP > 20 mmHg on 2 Consecutive Measurements After Administration of Study Medication||0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray|||participants|||Number
663332|NCT01807624|Secondary|Decrease in SBP > 20 mmHg on 2 Consecutive Measurements After Administration of Study Medication||0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray|||participants|||Number
663333|NCT01807624|Secondary|Increase in SBP > 20 mmHg on 2 Consecutive Measurements After Administration of Study Medication||0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray|||participants|||Number
663334|NCT01807624|Primary|AUC0-infinity of Oxymetazoline and PBBA||0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray|||ng*h/mL||Standard Deviation|Mean
663335|NCT01807624|Primary|AUC0-t of Oxymetazoline and PBBA||0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray|||ng*h/mL||Standard Deviation|Mean
663336|NCT01807624|Primary|Half-life of Oxymetazoline and PBBA||0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray|||minutes||Standard Deviation|Mean
663337|NCT01807624|Primary|Tmax of Oxymetazoline and PBBA||0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray|||minutes||Standard Deviation|Mean
663338|NCT01807624|Primary|Cmax of Oxymetazoline and PBBA||0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray|||ng/mL||Standard Deviation|Mean
663339|NCT01807455|Secondary|Adverse Event Reporting During the Study|Number of subjects reporting at least one adverse event (assessed as unrelated or related to treatment)|36 weeks|||participants|||Number
663340|NCT01807455|Secondary|Assessment of Local Tolerability After Treatment|Number of subjects reporting anticipated injection-related reactions after treatment|14 days|||participants|||Number
663341|NCT01807455|Secondary|Evaluation of Acne Scarring Using the Scale for Acne Scar Severity (SCAR-S)|Percentage of subjects improved at 36 weeks after first treatment session assessed using SCAR-S. Scale range is Very severe, Severe, Moderate, Mild, Almost clear and Clear. The alternative Clear is considered the best outcome. Improvement is considered to be at least one step improvement on the scale toward the alternative Clear.|36 weeks|||percentage of participants|||Number
663342|NCT01807455|Secondary|Evaluation of Skin Quality and Overall Satisfaction Using a Subject Satisfaction Questionnaire|Percentage of subjects satisfied with the overall appearance of the face at 36 weeks after first treatment session. Scale range is Very dissatisfied, Somewhat dissatisfied, Neither satisfied nor dissatisfied, Somewhat satisfied and Very satisfied. Alternatives Somewhat satisfied to Very satified are considered a better outcome.|36 weeks|||percentage of participants|||Number
663343|NCT01807455|Primary|Evaluation of Acne Scarring and the Surrounding Skin Using the Global Aesthetic Improvement Scale|Percentage of improved subjects at 36 weeks after first treatment session assessed using Subject GAIS. Scale range is Worse, No Change, Somewhat Improved, Much Improved and Very Much Improved. Alternatives Somewhat Improved to Very Much Improved are considered an improvement, i.e. a better outcome.|36 weeks|||percentage of participants|||Number
663344|NCT01807234|Secondary|Time to Pain Relief|9) The time, in minutes, will be measured from the time study drug is taken to the time when significant pain relief is first observed and maintained through 2 hours with no rescue medication use at or prior to this point.|following each treated migraine attack|||percentage of patients||95% Confidence Interval|Number
663345|NCT01807234|Secondary|Sustained Pain Freedom (SPF)|8) 24 and 48 hours sustained pain freedom (SPF); Defined as the reduction of pain to none. Pain was assessed using a 4-point scale (none, mild, moderate, and severe).|24 and 48 hours|||percentage of patients||95% Confidence Interval|Number
663346|NCT01807234|Secondary|Sustained Pain Relief (SPR)|7) 24 and 48 hours sustained pain relief (SPR) Defined as the reduction of pain to none or mild from moderate or severe, on a 4-point scale (none, mild, moderate, and severe).|24 and 48 hours|||percentage of patients||95% Confidence Interval|Number
663347|NCT01807234|Secondary|Self-assessment of Disability: Percentage of Participants With Moderate or Severe Disability|Participants’ self-assessment of disability was assessed using 4-point scales (none, mild, moderate, and severe). A binary outcome variable was created grouping none and mild vs moderate to severe. .|2-hours|||percentage of patients||95% Confidence Interval|Number
663348|NCT01807234|Secondary|Absence of Allodynia|5) Absence of allodynia The presence of allodynia was assessed based on a series of 8 questions inquiring as to the presence of allodynia. Participants answering 2 or more questions positively were considered to have allodynia.|2-hours|||percentage of patients||95% Confidence Interval|Number
663349|NCT01807234|Secondary|Absence of Nausea|4) Defined as reduction of nausea to none. Symptom was assessed using a 4-point scale (none, mild, moderate, and severe)|2-hours|||percentage of patients||95% Confidence Interval|Number
663350|NCT01807234|Secondary|Absence of Phonophobia|3) Defined as reduction of phonophobia to none. Symptom was assessed using a 4-point scale (none, mild, moderate, and severe)|2-hours|||percentage of patients||95% Confidence Interval|Number
663351|NCT01807234|Secondary|Absence of Photophobia|2) Defined as reduction of photophobia to none. Symptom was assessed using a 4-point scale (none, mild, moderate, and severe)|2-hours|||percentage of patients||95% Confidence Interval|Number
663352|NCT01807234|Secondary|Pain Freedom|1) Pain Freedom: Pain Freedom at 2 hours is defined as being free of pain. Pain was assessed using a 4-point scale (none, mild, moderate, and severe).|2-hours|||percentage of patients||95% Confidence Interval|Number
663353|NCT01807234|Primary|2- Hour Pain Relief|The primary outcome was 2-hour headache relief; headache relief was defined as headache pain from moderate or severe pain to none or mild pain. Pain was assessed using a 4-point scale (none, mild, moderate, and severe)|2 hours|||percentage of participants||95% Confidence Interval|Number
663354|NCT01807156|Secondary|Response Rate Based on Response Evaluation Criteria in Solid Tumors (RECIST) Criteria|"Measurable lesions: Lesions that can be measured in at least one dimension as ≥ 20 mm with conventional CT scan techniques or as ≥ 10 mm with spiral CT scan.
Non-measurable lesions: All other lesions including small lesions (longest diameter < 20 mm with conventional techniques) and other non-measurable lesions including: pleural effusions, ascites, and disease documented by indirect evidence (e.g. biochemical abnormalities).
Target lesions: All measurable lesions up to a maximum of 5 lesions. Target lesions are selected for their size and suitability for accurate repetitive measurements. The sum of the longest diameter of all target lesions will be calculated and reported as the baseline sum longest diameter (LD). This will be used as a reference to further quantify objective response.
Non-target lesions: All other lesions are identified as non-target lesions and should be followed as present or absent."|6 months|No response was observed in any of the patients.||participants|||Number
663355|NCT01807156|Primary|Number of Patients With Advanced Hepatocellular Cancer (HCC) Receiving Tivozanib Who Are Free From Progression|Evaluation of disease progression in the patients with advanced hepatocellular cancer (HCC) receiving tivozanib will be made using CT or MRI scan of the organ(s) with the target lesion(s). Response Evaluation Criteria In Solid Tumors (RECIST) criteria 1.1 will be used for objective tumor response assessment. Measurable lesions can be measured in at least one dimension as ≥ 20 mm with conventional CT scan techniques or as ≥ 10 mm with spiral CT scan. Target lesions are all measurable lesions up to a maximum of 5 lesions. Target lesions are selected for their size and suitability for accurate repetitive measurements. The sum of the longest diameter of all target lesions will be calculated and reported as the baseline sum longest diameter (LD). This will be used as a reference to further quantify objective response.|6 Months|||participants|||Number
663356|NCT01807000|Primary|Percent Total Radioactivity Excreted in Stool of Radiolabelled Prucalopride Succinate||Over 240 hours post-dose|Pharmacokinetic Analysis Set||percentage of radioactivity||Standard Deviation|Mean
663357|NCT01807000|Primary|Percent Total Radioactivity Excreted in Urine of Radiolabelled Prucalopride Succinate||240 hours post-dose|Pharmacokinetic Analysis Set||percentage of radioactvity||Standard Deviation|Mean
663358|NCT01807000|Primary|Half-Life Plasma Total Radioactivity of Radiolabelled Prucalopride Succinate||Over 240 hours post-dose|Pharmacokinetic Analysis Set||hours||Standard Deviation|Mean
663359|NCT01807000|Primary|Tmax Plasma Total Radioactivity of Radiolabelled Prucalopride Succinate||Over 240 hours post-dose|Pharmacokinetic Analysis Set||hours||Full Range|Median
663360|NCT01807000|Primary|Cmax Plasma Total Radioactivity of Radiolabelled Prucalopride Succinate||Over 240 hours post-dose|Pharmacokinetic Analysis Set||ng equivalents/ml||Standard Deviation|Mean
663361|NCT01807000|Primary|AUC 0→∞ Plasma Total Radioactivity of Radiolabelled Prucalopride Succinate||Over 240 hours post-dose|Pharmacokinetic Analysis Set||ng equivalents*h/ml||Standard Deviation|Mean
663362|NCT01807000|Primary|Half-Life Whole Blood Total Radioactivity of Radiolabelled Prucalopride Succinate||Over 240 hours post-dose|Pharmacokinetic Analysis Set||hours||Standard Deviation|Mean
663363|NCT01807000|Primary|Tmax Whole Blood Total Radioactivity of Radiolabelled Prucalopride Succinate||Over 240 hours post-dose|Pharmacokinetic Analysis Set||hours||Full Range|Median
663364|NCT01807000|Primary|Cmax Whole Blood Total Radioactivity of Radiolabelled Prucalopride Succinate||Over 240 hours post-dose|Pharmacokinetic Analysis Set||ng equivalents/ml||Standard Deviation|Mean
663365|NCT01807000|Primary|AUC 0→∞ Whole Blood Total Radioactivity of Radiolabelled Prucalopride Succinate||Over 240 hours post-dose|Pharmacokinetic Analysis Set||ng equivalents*h/ml||Standard Deviation|Mean
663366|NCT01807000|Primary|Volume of Distribution (Vz/F) of Radiolabelled Prucalopride Succinate|The distribution of a medication between plasma and the rest of the body.|Over 240 hours post-dose|Pharmacokinetic Analysis Set||Liters||Standard Deviation|Mean
663367|NCT01807000|Primary|Total Body Clearance (CL/F) of Radiolabelled Prucalopride Succinate|The rate at which a drug is removed from the body.|Over 240 hours post-dose|Pharmacokinetic Analysis Set||L/h||Standard Deviation|Mean
663368|NCT01807000|Primary|Plasma Half-Life (T1/2) of Radiolabelled Prucalopride Succinate|The time it takes for the blood plasma concentration of a substance to halve.|Over 240 hours post-dose|Pharmacokinetic Analysis Set||hours||Standard Deviation|Mean
663369|NCT01807000|Primary|Time to Maximum Plasma Concentration (Tmax) of Radiolabelled Prucalopride Succinate|Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached.|Over 240 hours post-dose|Pharmacokinetic Analysis Set||hours||Full Range|Median
666036|NCT01763905|Secondary|Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
663371|NCT01807000|Primary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) of Radiolabelled Prucalopride Succinate|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Over 240 hours post-dose|The Pharmacokinetic Analysis Set included all subjects with at least 1 pharmacokinetic parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set which included all subjects who took 1 dose of investigational product, underwent plasma pharmacokinetic sampling, and had evaluable pharmacokinetic assay results.||ng*h/ml||Standard Deviation|Mean
663372|NCT01806961|Secondary|Number of Newly Occurred Dermal Adverse and Serious Adverse Events on the Previous Treatment Area|recording of adverse events|at 6 and 12 months||||||
663373|NCT01806961|Secondary|Follow-up of AK-lesions (Existing Lesions, New Lesions, Changes)|clinical examination|at 6 and 12 months||||||
663374|NCT01806961|Primary|Determine the Recurrence Rate of AK-lesions|Number of patients with persistent complete clearance at 6 and 12 months follow-up. Recurrence rate is to be determined at the same treatment area where the investigational medicinal products were administered in the previous trial.|at 6 and 12 months|No subject was analysed due to premature study termination (sponsor's decision) therefore no data was available for analysis|||||
663375|NCT01806857|Secondary|Ashworth Spasticity Scale Score - Left Leg|This is a standard measure for spasticity that has been used in numerous ALS clinical trials to assess spasticity due to upper motor neuron dysfunction in ALS. Data is generated from the clinical exam and scored from 1-5, the lowest score indicating normal tone and the highest muscle rigidity.|Average between Baseline Visit to Visit 3|Includes all participants that received at least one dose of intervention.||units on a scale||Standard Deviation|Least Squares Mean
663376|NCT01806857|Secondary|Ashworth Spasticity Scale Score - Right Leg|This is a standard measure for spasticity that has been used in numerous ALS clinical trials to assess spasticity due to upper motor neuron dysfunction in ALS. Data is generated from the clinical exam and scored from 1-5, the lowest score indicating normal tone and the highest muscle rigidity.|Average between Baseline Visit to Visit 3|Includes all participants that received at least one dose of intervention.||units on a scale||Standard Deviation|Least Squares Mean
663377|NCT01806857|Secondary|Ashworth Spasticity Scale Score - Left Arm|This is a standard measure for spasticity that has been used in numerous ALS clinical trials to assess spasticity due to upper motor neuron dysfunction in ALS. Data is generated from the clinical exam and scored from 1-5, the lowest score indicating normal tone and the highest muscle rigidity.|Average between Baseline Visit to Visit 3|Includes all participants that received at least one dose of intervention.||units on a scale||Standard Deviation|Least Squares Mean
663378|NCT01806857|Secondary|Average Solids Swallowing Test|The Time Swallowing Test assesses the subject's ability to swallow solids. For this test, the subject will be asked to consume a tablespoon of cereal containing 5 cheerios. The subject will be instructed to close their mouth, chew and subsequently swallow the bolus. The time to complete this task will be recorded. The test will be completed three times to obtain an average score.|Average between Baseline Visit to Visit 3|Includes all participants that received at least one dose of intervention.||seconds||Standard Error|Least Squares Mean
663379|NCT01806857|Secondary|Visual Analog Scale - Salivation (Sialorrhea) Score|Visual analog scales are useful for measuring complex clinical events and offer the advantage of self-administration and responsiveness to change over time. The scales designed for this study inventory three domains of bulbar function: speech, swallowing and salivation (sialorrhea). For each of these, subjects score themselves by indicating their level of function on a scale of 1 (severe impairment) to 10 (normal). Scores range from 1 to 10; the higher the score, the more normal the function.|Average between Baseline Visit to Visit 3|Includes all participants that received at least one dose of intervention.||units on a scale||Standard Error|Least Squares Mean
663380|NCT01806857|Secondary|Visual Analog Scale - Swallowing Score|Visual analog scales are useful for measuring complex clinical events and offer the advantage of self-administration and responsiveness to change over time. The scales designed for this study inventory three domains of bulbar function: speech, swallowing and salivation (sialorrhea). For each of these, subjects score themselves by indicating their level of function on a scale of 1 (severe impairment) to 10 (normal). Scores range from 1 to 10; the higher the score, the more normal the function.|Average between Baseline Visit to Visit 3|Includes all participants that received at least one dose of intervention.||units on a scale||Standard Error|Least Squares Mean
663381|NCT01806857|Secondary|Average Water Swallowing Test (WST)|The Water Swallowing Test (WST) estimates swallowing speed, a useful and reproducible measure. While sitting, subjects are asked to drink 30 milliliters (mL) of liquid. The time for subjects to complete this task is a sensitive measure for the detection of swallowing dysfunction and is a simple measure for serial assessment of subjects. The test will be completed three times, with the best two scores recorded to obtain an average score. Following completion of the WST, the subject's swallowing abilities (choking, spillage, and effort) will be observed.|Average between Baseline Visit to Visit 3|Includes all participants that received at least one dose of intervention.||seconds||Standard Error|Least Squares Mean
663382|NCT01806857|Secondary|Timed Reading of Test Paragraph Result|Subjects will be asked to read 'The Rainbow Passage' a commonly used test paragraph utilized by speech pathologists to assess speech rate (words/minute). Study staff will time the subject to determine how many words the subject reads per minute. It is used primarily because it contains every sound in the English language. Subjects will also be observed for loudness, nasality, and intelligibility.|Average between Baseline Visit to Visit 3|Includes all participants that received at least one dose of intervention.||words per minute||Standard Error|Least Squares Mean
663383|NCT01806857|Secondary|Ashworth Spasticity Scale Score - Right Arm|This is a standard measure for spasticity that has been used in numerous ALS clinical trials to assess spasticity due to upper motor neuron dysfunction in ALS. Data is generated from the clinical exam and scored from 1-5, the lowest score indicating normal tone and the highest muscle rigidity.|Average between Baseline Visit to Visit 3|Includes all participants that received at least one dose of intervention.||units on a scale||Standard Deviation|Least Squares Mean
663395|NCT01806714|Secondary|Percentage of Participants Receiving HPV Vaccination (Dose 3)|Participants who received HPV vaccine dose 3 at end of study period Kaplan-Meier failure function|9 months|Only subjects with valid phone numbers were included and not all recipients got the 2nd dose. Only subjects who got the 2nd dose were then given the 3rd dose and only if they had working phone numbers.||percentage of eligible participants|||Number
663384|NCT01806857|Secondary|Visual Analog Scale - Speech Scores|Visual analog scales are useful for measuring complex clinical events and offer the advantage of self-administration and responsiveness to change over time. The scales designed for this study inventory three domains of bulbar function: speech, swallowing and salivation (sialorrhea). For each of these, subjects score themselves by indicating their level of function on a scale of 1 (severe impairment) to 10 (normal). Scores range from 1 to 10; the higher the score, the more normal the function.|Average between Baseline Visit to Visit 3|Includes all participants that received at least one dose of intervention.||units on a scale||Standard Error|Least Squares Mean
663385|NCT01806857|Secondary|ALS Functional Rating Scale- Revised (ALSFRS-R) Total Score|The ALSFRS-R is a quickly administered (5 min) ordinal rating scale used to determine a subject's assessment of their capability and independence in 12 functional activities. There are 12 questions, graded by the subject 0-4 (4 is normal). Score of 0 (worst) to 48 (best). Reflects speech and swallowing, fine motor skills, large motor skills, and breathing.|Average between Screening Visit to Visit 3|Includes all participants that received at least one dose of intervention.||units on a scale||Standard Error|Least Squares Mean
663386|NCT01806857|Secondary|Center for Neurologic Study - Lability Scale (CNS-LS) Total Score|The Center for Neurologic Study-Lability Scale (CNS-LS) is a 7-item self report scale that assesses pseudobulbar affect (PBA) by measuring the perceived frequency of PBA episodes (laughing or crying). Each item is scored using a 5-point Likert scale, from 1 (applies never) to 5 (applies most of the time). Scores range from 5-35. The higher the score, the worse the PBA.|Average between Screening Visit to Visit 3|Includes all participants that received at least one dose of intervention.||units on a scale||Standard Error|Least Squares Mean
663387|NCT01806857|Primary|Bulbar Function Scale (CNS-BFS) Swallowing Score|The Center for Neurologic Study-Bulbar Function Scale (CNS-BFS) is a 21-item self report scale that assesses three domains of bulbar function: speech, swallowing and salivation. Scores for each question range from 1 (does not apply) to 5 (applies most of the time). The higher the score, the worse the swallowing. There are 7 swallowing questions, with a score range of 7 to 35.|Average between Screening Visit to Visit 3|Includes all participants that received at least one dose of intervention.||units on a scale||Standard Error|Least Squares Mean
663388|NCT01806857|Primary|Bulbar Function Scale (CNS-BFS) Speech Score|The Center for Neurologic Study-Bulbar Function Scale (CNS-BFS) is a 21-item self report scale that assesses three domains of bulbar function: speech, swallowing and salivation. Scores for each question range from 1 (does not apply) to 5 (applies most of the time). The higher the score, the worse the speech. There are 7 speech questions, with a score range of 7 to 35.|Average between Screening Visit to Visit 3|Includes all participants that received at least one dose of intervention.||units on a scale||Standard Error|Least Squares Mean
663389|NCT01806857|Primary|Bulbar Function Scale (CNS-BFS) Sialorrhea Score|The Center for Neurologic Study-Bulbar Function Scale (CNS-BFS) is a 21-item self report scale that assesses three domains of bulbar function: speech, swallowing and salivation. Scores for each question range from 1 (does not apply) to 5 (applies most of the time). The higher the score, the worse the salivation (sialorrhea). There are 7 salivation (sialorrhea) questions, with a score range of 7 to 35.|Average between Screening Visit to Visit 3|Includes all participants that received at least one dose of intervention.||units on a scale||Standard Error|Least Squares Mean
663390|NCT01806857|Primary|Bulbar Function Scale (CNS-BFS) Total Score|"The Center for Neurologic Study-Bulbar Function Scale (CNS-BFS) is a 21-item self report scale that assesses three domains of bulbar function: speech, swallowing and salivation. Scores for each question range from 1 (does not apply) to 5 (applies most of the time). The higher the score, the worse the speech, swallowing and salivation (sialorrhea). [Range of score: 21-105]
The scale was modeled on the Center for Neurologic Study Emotional Lability Scale (CNS-LS) that has been a robust endpoint in four clinical trials. The scale was validated in a large population of ALS patients (n=122) and detects impaired bulbar function at a sensitivity of 90% and a specificity of 0.97%. Test re-test correlation was 0.92% at six-months (n=53)."|Average between Screening Visit to Visit 3|Includes all participants that received at least one dose of intervention.||units on a scale||Standard Error|Least Squares Mean
663391|NCT01806779|Other Pre-specified|Change in Smoking Withdrawal Symptoms|Withdrawal symptoms will be assessed by questionnaire on Quit Day, Week 1, Week 3, Week 7 and Week 11 post target quit date and 6 months post quit Follow-Up (if applicable) using the Shiffman-Jarvik questionnaire, which consists of 33-items rated from 1 to 7, where 1= not at all, 2= very little, 3= a little, 4= moderately, 5= a lot, 6= quite a lot, and 7= extremely. The 33 items are grouped into 8 subscales: Craving, Negative Affect, Appetite, Arousal, Somatic - Anxiety, Somatic - G.I., Somatic - Respiratory Tract, and Habit Withdrawal. The range of scores for each subscale will be 1-7, with higher scores indicating more of the withdrawal symptom having been experienced.|Quit Day and 1 week, 3 weeks, 7 Weeks, 11 Weeks and 6 months post Quit Day|A total of 163 subjects (Chantix n=82, Chantix+Zyban n=81) attended the first post-quit visit. However, ten subjects (5 in each condition) failed to complete or return their Quit Day withdrawal questionnaires; therefore change scores could only be calculated for 153 subjects (Chantix n=77, Chantix+Zyban n=76).||percentage of change||Standard Error|Mean
663392|NCT01806779|Secondary|Number of Participants Completing Continuous Abstinence From Smoking Between Quit Day and 11-week Post Quit Day Visit|This will be determined by a composite of self-report of no smoking between study visits at the 1-week, 3-week, 7-week and 11-week post Quit Day study visits and expired air carbon monoxide (CO) <10 ppm (measured at those study visits). An intent-to-treat criterion will be used, whereby drop-outs are considered to be non-abstinent.|Quit Day to 11-week post Quit Day study visit|||participants|||Number
663393|NCT01806779|Secondary|Number of Participants Completing Seven-day Point Abstinence From Smoking at 6 Months Post Quit Day|This will be determined by a self-report of no smoking for the previous seven days when called for 6-month follow-up confirmed by expired air CO.|6 months post Quit Day|||participants|||Number
663394|NCT01806779|Primary|Number of Participants Completing Continuous Four-week Abstinence From Smoking Between the 8-week and 11-week Post Quit Day Visits|This will be determined by a composite of self-report at the 11-week study visit of no smoking between the 8-week and 11-week visits and expired air carbon monoxide (CO) <10 ppm (measured at the 11-week study visit). An intent-to-treat criterion will be used, whereby drop-outs are considered to be non-abstinent.|Period between 8-week and 11-week visits post target Quit Day|||participants|||Number
664013|NCT01791894|Secondary|Patients With Stable Disease Post Treatment|Number of patients with stable disease post treatment by RECIST criteria|After 3 cycles of treatment (approx. 61 days)|4 patients completed 3 cycles of treatment||participants|||Number
663396|NCT01806714|Secondary|Percentage of Participants Receiving HPV Vaccination (Dose 2)|Participants who received HPV vaccine dose 2 at end of study period Kaplan-Meier failure function|9 months|Only subjects with a valid phone number at the time dose 2 was dispensed received the vaccine. The number of subjects receiving dose 2 is higher than dose 1 because some phones numbers that were inactive during dose 1 were active during dose 2.||percentage of eligible participants|||Number
663397|NCT01806714|Primary|Percentage of Participants Receiving HPV Vaccination (Dose 1)|Participants who received HPV vaccine dose 1 Kaplan-Meier failure function|9 months|Only subjects with valid phone numbers at the time dose 1 was dispensed received dose 1.||percentage of eligible participants|||Number
663398|NCT01806623|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Vaginal Fluid Fluconazole Concentration Adjusted by Potassium in Vaginal Fluid|Area under the concentration time-curve from zero to the last measured concentration (AUClast) for Vaginal Fluid Fluconazole Concentration Adjusted by Potassium in Vaginal Fluid|Before dosing and 2, 24, 48 and 168 hours after dosing|The vaginal discharge parameter analysis set was defined as those participants who were included in the vaginal discharge concentration analysis set and for whom at least one set of vaginal discharge parameters was calculated.||mcg*h/mL||Geometric Coefficient of Variation|Geometric Mean
663399|NCT01806623|Secondary|Time to Reach Maximum Observed Concentration (Tmax) for Vaginal Fluid Fluconazole Concentration Adjusted by Potassium in Vaginal Fluid||Before dosing and 2, 24, 48 and 168 hours after dosing|The vaginal discharge parameter analysis set was defined as those participants who were included in the vaginal discharge concentration analysis set and for whom at least one set of vaginal discharge parameters was calculated.||hrs||Full Range|Median
663400|NCT01806623|Secondary|Maximum Observed Concentration (Cmax) for Vaginal Fluid Fluconazole Concentration Adjusted by Potassium in Vaginal Fluid||Before dosing and 2, 24, 48 and 168 hours after dosing|The vaginal discharge parameter analysis set was defined as those participants who were included in the vaginal discharge concentration analysis set and for whom at least one set of vaginal discharge parameters was calculated.||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
663401|NCT01806623|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Vaginal Fluid Fluconazole Concentration Adjusted by Sample Weight|Area under the concentration time-curve from zero to the last measured concentration (AUClast) for Vaginal Fluid Fluconazole Concentration adjusted by Sample Weight|Before dosing and 2, 24, 48 and 168 hours after dosing|The vaginal discharge parameter analysis set was defined as those participants who were included in the vaginal discharge concentration analysis set and for whom at least one set of vaginal discharge parameters was calculated.||mcg*h/g||Geometric Coefficient of Variation|Geometric Mean
663402|NCT01806623|Secondary|Time to Reach Maximum Observed Concentration (Tmax) for Vaginal Fluid Fluconazole Concentration Adjusted by Sample Weight||Before dosing and 2, 24, 48 and 168 hours after dosing|The vaginal discharge parameter analysis set was defined as those participants who were included in the vaginal discharge concentration analysis set and for whom at least one set of vaginal discharge parameters was calculated.||hours||Full Range|Median
663403|NCT01806623|Secondary|Maximum Observed Concentration (Cmax) for Vaginal Fluid Fluconazole Concentration Adjusted by Sample Weight||Before dosing and 2, 24, 48 and 168 hours after dosing|The vaginal discharge parameter analysis set was defined as those participants who were included in the vaginal discharge concentration analysis set and for whom at least one set of vaginal discharge parameters was calculated.||mcg/g||Geometric Coefficient of Variation|Geometric Mean
663404|NCT01806623|Secondary|Area Under the Plasma Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|Before dosing and 2, 24, 48 and 168 hours after dosing|The plasma parameter analysis set was defined as those participants who were included in the plasma concentration analysis set and for whom at least one set of plasma concentration parameters was calculated.||mcg*h/mL||Geometric Coefficient of Variation|Geometric Mean
663405|NCT01806623|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||Before dosing and 2, 24, 48 and 168 hours after dosing|The plasma parameter analysis set was defined as those participants who were included in the plasma concentration analysis set and for whom at least one set of plasma concentration parameters was calculated.||hours||Full Range|Median
663406|NCT01806623|Secondary|Maximum Observed Plasma Concentration (Cmax)||Before dosing and 2, 24, 48 and 168 hours after dosing|The plasma parameter analysis set was defined as those participants who were included in the plasma concentration analysis set and for whom at least one set of plasma concentration parameters was calculated.||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
663407|NCT01806623|Secondary|Total Scores for Clinical Symptoms|Sum of severity scores in vulvovaginal itching, vulvovaginal burning sensation, excoriation of vulva, vaginal discharge, vulva oedema, redness of vulva, vaginal redness, property of vaginal content. Higher scores show greater severity. Total Scores for Clinical Symptoms Severity range from 0 (best possible outcome) to 24 (worst possible outcome).|Day 1 (before dosing), Day 3, Day 7, Day 14 and Day 28|The modified-Intent to Treat (m-ITT) included participants with vulvovaginal candidiasis who received the investigational products, who tested positive for Candida in the vulva and/or vagina at Day 1 (before dosing), and whose clinical efficacy was evaluated.||score on s scale||Full Range|Mean
663408|NCT01806623|Secondary|Mycological Efficacy: Eradication Rate|"Determined based on the results of culture of Candida as Eradication, Persistent or Indeterminate.
Eradication rate was calculated based on the following formula, the number of participants assessed as Eradication over total participants excluding ones assessed as Indeterminate multiplied by 100."|Day 7, Day 14 and Day 28|The modified-Intent to Treat (m-ITT) included participants with vulvovaginal candidiasis who received the investigational products, who tested positive for Candida in the vulva and/or vagina at Day 1 (before dosing), and whose clinical efficacy was evaluated.||percentage of participants||95% Confidence Interval|Number
663442|NCT01805297|Secondary|Changes in Mean Central Retinal Thickness.|The amount of thickness change in microns from baseline to 6 month visit. A positive number indicates an increase in thickness and a negative number would indicate a decrease in thickness.|24 weeks|Due to lack of clear view due to vitreous Hemorrhage, all but 2 patients were unable to have optical coherence tomography at baseline, and one these was lost to follow up. For this reason, data collected for the few patients who were able to have the test was not analyzed||Microns|||Number
663443|NCT01805297|Secondary|Need for Any Additional Surgical Intervention.||24 weeks|||Participants|||Count of Participants
663409|NCT01806623|Secondary|Clinical Efficacy: Cure and Improvement Rate|"Scores of severity in signs and symptoms on each observation dates are compared with those before the treatment and the clinical efficacy is determined as Cure (the clinical symptom disappeared), Improvement (the clinical symptom was improved), Failure (the criteria for Cure and Improvement were not met, or other systemic antifungal drugs or local antifungal drugs were administered for the treatment of the disease to be examined) or Indeterminate (efficacy for each item was not determined for the reasons including failure to conduct the test, or other systemic antifungal agents or local antifungal drugs were administered for the treatment of infections other than the disease to be examined).
Cure and improvement rate was calculated based on the following formula, the number of participants assessed as Cure or Improvement over total participants excluding ones assessed as Indeterminate multiplied by 100."|Day 7, Day 14 and Day 28|The modified-Intent to Treat (m-ITT) included participants with vulvovaginal candidiasis who received the investigational products, who tested positive for Candida in the vulva and/or vagina at Day 1 (before dosing), and whose clinical efficacy was evaluated.||percentage of participants||95% Confidence Interval|Number
663410|NCT01806623|Secondary|Clinical Efficacy: Cure Rate|"Scores of severity in signs and symptoms at each observation dates were compared with those before the treatment and the clinical efficacy was determined as Cure (the clinical symptom disappeared), Improvement (the clinical symptom was improved: the total score of clinical symptom was reduced relative to the total score before the treatment), Failure (the criteria for Cure and Improvement were not met, or other systemic antifungal drugs or local antifungal drugs were administered for the treatment of the disease to be examined) or Indeterminate (efficacy for each item was not determined for the reasons including failure to conduct the test, or other systemic antifungal agents or local antifungal drugs were administered for the treatment of infections other than the disease to be examined).
Cure rate was calculated based on the following formula, the number of participants assessed as Cure over total participants excluding ones assessed as Indeterminate multiplied by 100."|Day 7, Day 14 and Day 28|The modified-Intent to Treat (m-ITT) included participants with vulvovaginal candidiasis who received the investigational products, who tested positive for Candida in the vulva and/or vagina at Day 1 (before dosing), and whose clinical efficacy was evaluated.||percentage of participants||95% Confidence Interval|Number
663411|NCT01806623|Primary|Therapeutic Outcome: Response Rate|"Therapeutic outcome was determined by combination of clinical efficacy and mycological efficacy for each participant as Effective, Ineffective or Indeterminate. The therapeutic outcome was considered as Effective when the clinical efficacy was Cure and the mycological efficacy was Eradication.
Primary evaluation of therapeutic outcome was on Day 28.
Response rate was calculated based on the following formula, the number of participants assessed as effective over total participants excluding ones assessed as indeterminate multiplied by 100."|Day 7, Day 14 and Day 28|The modified-Intent to Treat (m-ITT) included participants with vulvovaginal candidiasis who received the investigational products, who tested positive for Candida in the vulva and/or vagina at Day 1 (before dosing), and whose clinical efficacy was evaluated.||percentage of participants||95% Confidence Interval|Number
663412|NCT01806584|Secondary|Number of Interventions to Establish, Maintain, or Restore Patency|The total numbers of interventions to establish, maintain, or restore patency was assessed at the Week 26 visit.|26 weeks after surgery|The ITT population, defined as all randomly assigned participants regardless of the treatment received or having post-baseline outcome data.||interventions||Standard Deviation|Mean
663413|NCT01806584|Secondary|Percentage of Participants With Loss of Secondary Patency|Secondary patency (access survival until abandonment) was defined as the duration of time in days from the date of randomization (AVG placement) until the date of access abandonment. Assessment of AVG patency was evaluated during physical examination of the subject’s AVG at each visit and through ongoing AVG monitoring and surveillance according to each participating site’s standard practice. It was recommended to follow the National Kidney Foundation Kidney guidelines (National Kidney Foundation 2006) on appropriate management and treatment of AVG complications to improve the function and longevity of the vascular access.|Up to 78 weeks after surgery|The ITT population, defined as all randomly assigned participants regardless of the treatment received or having post-baseline outcome data.||percentage of participants|||Number
663414|NCT01806584|Secondary|Percentage of Participants With Loss of Assisted Primary Patency|Assisted primary patency (thrombosis--free access survival) was defined as the duration of time in days from the date of randomization (AVG placement) until the first date of (a) occlusion (commonly due to thrombosis) or (b) access abandonment. Assessment of AVG patency was evaluated during physical examination of the subject’s AVG at each visit and through ongoing AVG monitoring and surveillance according to each participating site’s standard practice. It was recommended to follow the National Kidney Foundation Kidney guidelines (National Kidney Foundation 2006) on appropriate management and treatment of AVG complications to improve the function and longevity of the vascular access.|Up to 78 weeks after surgery|The ITT population, defined as all randomly assigned participants regardless of the treatment received or having post-baseline outcome data.||percentage of participants|||Number
663415|NCT01806584|Primary|Percentage of Participants With Loss of Unassisted Primary Patency|Unassisted primary patency (intervention--free access survival) was defined as the duration of time in days from the date of randomization (arteriovenous graft [AVG] placement) until the first date of (a) any intervention designed to establish, maintain, or restore patency, (b) occlusion (commonly due to thrombosis), or (c) access abandonment. Assessment of AVG patency was evaluated during physical examination of the subject’s AVG at each visit and through ongoing AVG monitoring and surveillance according to each participating site’s standard practice. It was recommended to follow the National Kidney Foundation Kidney guidelines (National Kidney Foundation 2006) on appropriate management and treatment of AVG complications to improve the function and longevity of the vascular access.|Up to 78 weeks after surgery|The Intent to-Treat (ITT) population, defined as all randomly assigned participants regardless of the treatment received or having post-baseline outcome data.||percentage of participants|||Number
663416|NCT01806545|Secondary|Number of Interventions to Establish, Maintain, or Restore Patency|The total number of interventions to establish, maintain, or restore patency was recorded for each participant.|12 and 26 weeks after surgery|The ITT population, defined as all randomly assigned participants regardless of receiving treatments or having post-baseline outcome data.||interventions||Standard Deviation|Mean
663463|NCT01804946|Secondary|The Number of the Antipyretic Intake|A subject recorded the number of antipyretic intake in patient diary.|Day 1 to Day 5|Per Protocol set||Number of Doses||Standard Deviation|Mean
663417|NCT01806545|Secondary|Percentage of Participants With Clinical Success Based on First Use of The Study AVF For Hemodialysis|Clinical success was defined as the ability to undergo hemodialysis using the AVF. The date of clinical success corresponded to the date of the first use of the study AVF for hemodialysis as determined by the investigator, following discussion with the subject. Clinical success was assessed in a continuous fashion and, once achieved, the AVF was considered a clinical success at that and all subsequent time points. The date of clinical success based on the first use of the AVF for hemodialysis was compared with the dates of each study visit (Week 12 and Week 26); for study visits occurring prior to the date of clinical success based on the first use of the AVF for hemodialysis, the subject was counted as a nonsuccess and for study visits occurring on or after the date of maturation based on the first use of the AVF for hemodialysis, the subject was counted as a success.|12 and 26 weeks after surgery|The ITT population, defined as all randomly assigned participants regardless of receiving treatments or having post-baseline outcome data.||percentage of participants|||Number
663418|NCT01806545|Secondary|Change From Week 1 in Average Vascular Access Lumen Diameter Using CDUS|B-mode lumen diameter measurements were obtained in the outflow vein as 3 separate images for each location: at 1, 3, and 5 centimeter into the vein and from the toe of the venous anastomosis. The average of lumen diameter measurements obtained at 1, 3, and 5 cm from the anastomosis was used for this endpoint.|1, 12, and 26 weeks after surgery|The ITT population, defined as all randomly assigned participants regardless of receiving treatments or having post-baseline outcome data.||millimeters||Standard Deviation|Mean
663419|NCT01806545|Secondary|Percentage of Participants With Loss of Secondary Patency|The time to loss of secondary patency (access survival until abandonment) was defined as the duration of time in days from the date of randomization (AVF creation) until the date of access abandonment.|Up to 26 weeks after surgery|The ITT population, defined as all randomly assigned participants regardless of receiving treatments or having post-baseline outcome data.||percentage of participants|||Number
663420|NCT01806545|Secondary|Percentage of Participants With Loss of Assisted Primary Patency|The time to loss of assisted primary patency (thrombosis--free access survival) was defined as the duration of time in days from the date of randomization (AVF creation) until the first date of (a) occlusion (commonly due to thrombosis) or (b) access abandonment.|Up to 26 weeks after surgery|The ITT population, defined as all randomly assigned participants regardless of receiving treatments or having post-baseline outcome data.||percentage of participants|||Number
663421|NCT01806545|Secondary|Percentage of Participants With Loss of Unassisted Primary Patency|The time to loss of unassisted primary patency (intervention--free access survival) was defined as the duration of time in days from the date of randomization (AVF creation) until the first date of (a) any intervention designed to establish, maintain, or restore patency; (b) occlusion (commonly due to thrombosis); or (c) access abandonment.|Up to 26 weeks after surgery|The ITT population, defined as all randomly assigned participants regardless of receiving treatments or having post-baseline outcome data.||percentage of participants|||Number
663422|NCT01806545|Secondary|Time to AVF Maturation Based on Hemodialysis or CDUS and Vascular Access Examination|Time to AVF maturation was defined as the duration of time (in days) from the date of randomization (AVF creation) to the date of maturation, where the date of maturation corresponds to the earlier of either the date of the first use of the study AVF for hemodialysis as determined by the investigator following discussion with the participant, or the date the AVF meets all of the following 3 criteria as determined through CDUS and vascular access examination: presence of bruit throughout systole and diastole at least 8 centimeters proximal to the venous anastomosis, blood flow through the outflow vein of at least 500 milliliters (ml) per minute, and a lumen diameter of the outflow vein at least 4 mm. Participants who died, underwent a kidney transplant, or were either lost to follow-up or did not mature during the study follow-up were censored at the time of death, time of transplant, or time of last visit, respectively.|Up to 26 weeks after surgery|The ITT population, defined as all randomly assigned participants regardless of receiving treatments or having post-baseline outcome data.||days||Inter-Quartile Range|Median
663423|NCT01806545|Secondary|Percentage of Participants With AVF Maturation by Week 26 Visit Based on Hemodialysis or CDUS And Vascular Access Examination|Maturation based on CDUS was assessed in a continuous fashion and was defined by the following criteria: presence of bruit throughout systole and diastole at least 8 centimeters (cm) proximal to the venous anastomosis, blood flow through the outflow vein of at least 500 milliliters (ml) per minute, and a lumen diameter of the outflow vein at least 4 mm. Maturation was determined by CDUS and vascular access examination or by first use of the AVF for hemodialysis based on investigator-reported use. Participants who discontinued prior to the Week 26 visit without assessment of maturity were considered treatment failures.|26 weeks after surgery|The ITT population, defined as all randomly assigned participants regardless of receiving treatments or having post-baseline outcome data.||percentage of participants|||Number
663424|NCT01806545|Primary|Percentage of Participants With Arteriovenous Fistula (AVF) Maturation by Week 12 Visit Based on Hemodialysis or Color-flow Doppler Ultrasound (CDUS) And Vascular Access Examination|Maturation based on CDUS was assessed in a continuous fashion and was defined by the following criteria: presence of bruit throughout systole and diastole at least 8 centimeters (cm) proximal to the venous anastomosis, blood flow through the outflow vein of at least 500 milliliters (ml) per minute, and a lumen diameter of the outflow vein at least 4 mm. Maturation was determined by CDUS and vascular access examination or by first use of the AVF for hemodialysis based on investigator-reported use. Participants who discontinued prior to the Week 12 visit without assessment of maturity were considered treatment failures.|12 weeks after surgery|The Intent- to-Treat (ITT) population, defined as all randomly assigned participants regardless of receiving treatments or having post-baseline outcome data.||percentage of participants|||Number
663425|NCT01806389|Primary|Infant Plasma Concentrations of Buprenorphine|Infant plasma concentrations of buprenoprhine obtained on day 14 of life|Day 14 of life|||ug/mL||Full Range|Median
663426|NCT01806389|Primary|Maternal Breast Milk Concentrations of Buprenorphine|Breast milk will be obtained on these days at the time of peak plasma levels of buprenoprhine|Days 2,3,4,14 and 30 after delivery|||ug/mL||Full Range|Median
663427|NCT01806389|Primary|Maternal Plasma Concentrations of Buprenorphine|Maternal plasma will be obtained at the time of peak buprenorphine levels on days 2,3,4,14 and 30|Days 2,3,4,14 and 30 after delivery|||ug/mL||Full Range|Median
666037|NCT01763905|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
663428|NCT01806298|Other Pre-specified|Number of Subjects With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death, TEAEs Leading to Discontinuation|An adverse event (AE) was defined as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the study drug. An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs are those events with onset dates occurring during the on-treatment period or if the worsening of an event is during the on-treatment period. TEAEs include both Serious TEAEs and non-serious TEAEs.|Baseline up to Week 41|The safety analysis set included all treated subjects who had received at least 1 administration of Saizen®.||Participants|||Count of Participants
663429|NCT01806298|Secondary|Treatment Adherence Rate as Documented Using EasypodTM Connect|Treatment adherence rate was measured by: (total dose received divided by total dose prescribed) multiplied by 100. Saizen solution for injection was administered using the easypod device and treatment adherence information was obtained from the device using the easypod connect software.|Week 2, 8, 16, 29 and 39|"The safety analysis set included all treated subjects who had received at least 1 administration of Saizen®. Here, Number Analyzed signifies those subjects who were evaluable for the specified category at each time point."||percentage of treatment adherence||Standard Deviation|Mean
663430|NCT01806298|Secondary|Insulin-like Growth Factor-I Standard Deviation Score (IGF-I SDS)|Insulin-like Growth Factor-1 SDS was calculated based on the actual value of IGF-1 minus reference value of IGF-1 divided by reference standard deviation of IGF-1. SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) a subject’s value was relative to the mean of the reference population. The scores were centered around zero. Negative score indicated that the IGF-I value was lower compared to the reference population.|Baseline, Week 2, 8, 16, 29, 39 and 41|"The safety analysis set included all treated subjects who had received at least 1 administration of Saizen®. Here, Number Analyzed signifies those subjects who were evaluable for the specified category at each time point."||Standard deviation score||Standard Deviation|Mean
663431|NCT01806298|Secondary|Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels|Growth Hormone (GH) biomarker levels were summarized by GH treatment status at study entry (that is subjects were classified as GH treatment-naïve subjects or subjects with prior GH treatment for adult growth hormone deficiency [AGHD])|Baseline, Week 2, 8, 16, 29, 39 and 41|"The safety analysis set included all treated subjects who had received at least 1 administration of Saizen®. Here, Number Analyzed signifies those subjects who were evaluable for the specified category at each time point."||milligram/liter (mg/L)||Standard Deviation|Mean
663432|NCT01806298|Secondary|Insulin-like Growth Factor-I (IGF-I) Levels|Growth Hormone (GH) biomarker levels were summarized by GH treatment status at study entry (that is subjects were classified as GH treatment-naïve subjects or subjects with prior GH treatment for adult growth hormone deficiency [AGHD]).|Baseline, Week 2, 8, 16, 29, 39 and 41|The safety analysis set included all treated subjects who had received at least 1 administration of Saizen®. Here, “Number Analyzed” signifies those subjects who were evaluable for the specified category at each time point.||nanomoles per liter (nmol/L)||Standard Deviation|Mean
663433|NCT01806298|Secondary|Percentage of Subjects With Binding Antibodies (BAbs) Who Became Positive for Neutralizing Antibodies (NAbs)|Percentage of subjects with BAbs who become positive for NAbs = (Number of NAb positive subjects / Number of BAbs positive subjects) x 100|Baseline up to Week 39|Data could not be analyzed as there were no subjects who were BAb positive.|||||
663434|NCT01806298|Primary|Percentage of Subjects Developing Binding Antibodies (BAbs) to Saizen®|Percentage of subjects developing BAbs = (Number of BAb positive subjects / Total number of subjects) x 100.|Baseline up to Week 39|The modified Intent-To-Treat (mITT) analysis set included all treated subjects who had received at least 1 administration of Saizen® and had at least 1 post-baseline BAbs assessment.||percentage of subjects||95% Confidence Interval|Number
663435|NCT01806051|Primary|Changes in Plasma Phe and Tyrosine Levels|To evaluate the patterns of change in plasma Phe and tyrosine levels between the Baseline visit and 4 week visit for each arm.|Baseline and 4 weeks|Participants withdrew before any data were collected.|||||
663436|NCT01805882|Primary|The Proportion of Subjects Who Achieve Sustained Viral Response (SVR12) 12 Weeks After the Stop of Treatment Drugs|The primary outcome was the proportion of patients with sustained viral response measured 12 weeks after the stop of treatment. The viral response was assessed by serum HCV RNA concentrations lower than 43 IU/mL - the lower limit of quantification.|12 weeks after stop of treatment|Subjects who received treatment drugs per arm as listed in the Outcome Measure Description||percentage of subjects||95% Confidence Interval|Number
663437|NCT01805687|Secondary|Number of Subjects With Adverse Events||72 Hours||||||
663438|NCT01805687|Secondary|Area Under the Curve (AUC)||72 Hours||||||
663439|NCT01805687|Primary|Change From Baseline in FEV1||12 Hours|||Liter||Standard Deviation|Mean
663440|NCT01805323|Secondary|Peak Mean Change From Baseline in Central Retinal Thickness (CRT)|Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed in the study eye. The peak mean change was the maximum change from Baseline in CRT at 2 to 26 weeks following the last available injection of OZURDEX®. A negative change from Baseline indicated improvement.|Baseline, 2 to 26 weeks following last injection (up to 6.5 months)|All participants with CRT observations available following the last OZURDEX® injection from 2 to 26 weeks.||microns (μm)|Participants|Standard Error|Mean
663441|NCT01805323|Primary|Peak Mean Change From Baseline in Best Corrected Visual Acuity (BCVA)|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). The peak mean change in BCVA was calculated using the most improved number of lines read correctly between 2 and 26 weeks following the last available injection of OZURDEX® - the number of lines read correctly at Baseline. A positive change from Baseline indicated improvement.|Baseline, 2 to 26 weeks (wks) following last injection (up to 6.5 months)|All participants with BCVA observations available following the last OZURDEX® injection from 2 to 26 weeks.||Lines|Participants|Standard Error|Mean
663444|NCT01805297|Secondary|Mean Change in Visual Acuity|"Change in visual acuity measured using Early Treatment of Diabetic Retinopathy Study visual acuity charts and letter score difference from baseline to 6 month. A greater number indicates a higher increase in vision from the baseline score. A negative number would indicate that vision decreased."|24 weeks|Patients who completed 24 week visit||Number of letters Read||Full Range|Mean
663445|NCT01805297|Primary|Rate of Resolved Post-operative Vitreous Hemorrhage.|Percentage of patients who had no vitreous hemorrhage before or at week 24|24 weeks|||Participants|||Count of Participants
663446|NCT01805180|Secondary|Safety|"Serious adverse events (SAEs) and unanticipated (serious) adverse device/procedure- related events (UADEs), adverse events (AEs).
any clinically significant changes to Complete Blood Count with differential white cell count (CBCD) and any significant changes to vital signs (temperature, heart rate, blood pressure) were captured as AEs. Also provided in full report to FDA."|48-hours after last procedure|||events|||Number
663447|NCT01805180|Secondary|Usability/Assessment of System Operation - Device Malfunctions||Result know immediately upon successful completion of procedure|||events|||Number
663448|NCT01805180|Secondary|Usability/Assessment of System Operation - Adjustments|Number of operator adjustments aimed at establishing and maintaining the plasma/ cellular interface: namely, on Spectra Optia, the adjustment of collection preference and, on COBE Spectra, the adjustment of the plasma pump flow rate.|Adjustments known immediately upon completion of the procedure|||number of adjustments||Standard Deviation|Mean
663449|NCT01805180|Secondary|Usability/Assessment of System Operation - Time|Procedure time for collections on the Spectra Optia vs. the COBE Spectra.|Result captured immediately upon completion of procedure|||minutes||Standard Deviation|Mean
663450|NCT01805180|Secondary|Characterization of the Blood Product - Volume|Characterization of the collected blood product, specifically product volume.|within 5 minutes after collection procedure|||mL||Standard Deviation|Mean
663451|NCT01805180|Secondary|Characterization of the Blood Product - RBC Contamination|Characterization of the collected blood product, specifically red blood cell (RBC) contamination as measured by hematocrit in the collected PMN product.|within 5 minutes after collection procedure|||RBC percent of product volume||Standard Deviation|Mean
663452|NCT01805180|Secondary|Characterization of the Blood Product - PMN Cell Viability|Characterization of the collected blood product, specifically PMN cell viability measured by an assay preformed on the collected blood product.|within 5 minutes after collection procedure|||percent of viable cells||Standard Deviation|Mean
663453|NCT01805180|Secondary|Characterization of Blood Product - PMN Cell Yield Per Liter of Blood Processed|Characterization of the collected blood product, specifically PMN cell yield per liter blood processed. This is a measurement of device performance measured by calculating cell counts in samples from the collected blood product and blood processed measured by the device.|within 5 minutes after each collection procedure|||cells *10^10 per L of blood processed||Standard Deviation|Mean
663454|NCT01805180|Secondary|Characterization of Blood Product - PMN Cell Yield|Characterization of the collected blood product, specifically total PMN cell yield. This is a measurement of device performance measured by calculating cell counts in samples from the collected blood product.|within 5 minutes after each collection procedure|||cells *10^10||Standard Deviation|Mean
663455|NCT01805180|Secondary|Performance|Comparison of collection efficiencies associated with the Granulocyte Cell Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems for white blood cells and platelets. CE is a measurement of device performance calculated using donor and blood product blood counts collected immediately before and after the collection procedure.|within 1 hour prior and within 5 minutes after each collection procedure|||percent of cells processed||Standard Deviation|Mean
663456|NCT01805180|Primary|Granulocyte/PMN Cell Collection Efficiency|The primary endpoint is the granulocyte/PMN cell collection efficiency (CE) associated with the Granulocyte (PMN) Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems. CE is a measurement of device performance calculated using donor and blood product blood counts collected immediately before and after the PMN collection procedure.|within 1 hour prior and within 5 minutes after each collection procedure|||percent cells processed||Standard Deviation|Mean
663457|NCT01805089|Secondary|Change in Mood, Sleep Quality and Menopausal Symptoms From Baseline to 4 Months|Mood was assessed by the Center for Epidemiologic studies Depression Scale. The scale measures depressive symptoms in 20 items. Each question has a 4 point answer (0-3) so the scale range is 0-60. A higher score indicates more depression. Sleep quality was assessed by the Pittsburgh Sleep Quality Index. There are 19 questions each with a 3 point answer. The questions are grouped into 7 subscales and each has a value from 0-3. The 7 subscales are then added together to yield a global score with a range of 0-21. Higher scores indicate worse sleep. Menopausal symptoms were assessed by NCCTG Hot Flash diary. Subjects track the number and severity of hot flashes daily for 1 week. Subjects grade the severity of the hot flashes on a scale of 1-4, with 1 being mild and 4 very severe. Frequency and the severity determine the score . The minimum score is 0 (no hot flashes) and there is no maximum score. A higher score indicates more severe hot flashes. There are no subscales or no units.|baseline and 4 months|||change in PSQI score||Standard Deviation|Mean
663458|NCT01805089|Primary|Compliance|To evaluate compliance with a 4 month course of melatonin. Compliance was assessed via pill counts.|4 months|||participants|||Number
663459|NCT01805089|Primary|Absolute Plasma Estradiol Levels After 4 Month Course of Melatonin or Placebo|Absolute plasma estradiol levels after 4 month course of melatonin or placebo, only 4 month level provided below.|4 months|||pg/ml||Standard Deviation|Mean
663460|NCT01804946|Secondary|Percentage of Patients With Complications of the Influenza|Pneumonia, sinusitis, otitis media are examples of the influenza complications|Day 1 to Day 7|Per Protocol set||Percentage of participants|||Number
663461|NCT01804946|Secondary|Change in the Subjective Health Status|The patient subjective health status assessment was based on Visual Analogue Scale − VAS). VAS includes a rating of current health status from 0 (worst) to 100 (best).|Day 7 vs. Day 1|Per Protocol set||Scores on a scale||Standard Deviation|Mean
663462|NCT01804946|Secondary|Change in the Patient’s Quality of Life.|The quality of life was assessed in influenza patients at baseline and at the end of the treatment period using the European Quality of Life Questionnaire (EQ5D) measuring the health status by five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression (each dimension is assessed by 1 to 3 point scale; the minimum score 5 points refers to the best status, 15 points refers to the worst status).|Day 7 vs. Day 1|Per Protocol set||Scores on a scale||Standard Deviation|Mean
663464|NCT01804946|Secondary|Severity of Influenza Symptoms (Total Score of the Common Symptoms and Respiratory Symptoms)|The severity of influenza symptoms was assessed during a physical examination at Day 1, 3 and 7; common (10 symptoms) and respiratory (5 symptoms) symptom’s total score was assessed with using the point scale: 0=No symptom; 1=Mild symptom; 2=Moderate symptom ; 3=Severe symptom. The Common Symptoms total score ranged from 0 (no symptoms) to 30 (severe symptoms). The Respiration Symptoms total score ranged from 0 (no symptoms) to 15 (severe symptoms)|on days 1, 3 and 7 of the observation|Per Protocol set||Scores on a scale||Standard Deviation|Mean
663465|NCT01804946|Secondary|Mean Body Temperature|The axillary temperature was assessed during a physical examination at Day 1, 3 and 7; axillary temperature was assessed in degrees (Celsius, °С)|on days 1, 3 and 7 of the observation|Per Protocol set||°C||Standard Deviation|Mean
663466|NCT01804946|Secondary|Time to Resolution of the Influenza|"Time to resolution was considered as time to the absence of any flu symptom. Absence of symptoms was considered as axillary temperature decline to or below 37.0 ºС without subsequent rise, resolution of the common and respiratory symptoms.
The duration of a symptom was defined by physician recorded presence/absence of the symptoms during a physical examination at Day 1 to Day 7."|Day 1 to Day 7|Per Protocol set||Days||Standard Deviation|Mean
663467|NCT01804946|Secondary|Percentage of Patients With Resolution of Influenza Symptoms|Assessment of the proportion of subjects with no clinical symptoms of the disease (fever, common and respiratory symptoms) at Study Day 7 (Visit 3). The severity of influenza symptoms was assessed by a physician with 0 to 3 point scale, where 0 means no symptom, 1=mild symptom, 2=moderate symptom, and 3=severe symptom|on the day 7 of the observation|Per Protocol set.||Percentage of participants|||Number
663468|NCT01804946|Primary|Percentage of Patients With Normal Body Temperature|Axillary temperature (morning and evening) decline to or below 37.0 ºС (without subsequent increase during ≥24 h)|Day 1 to Day 5|The Per Protocol (PP) set includes subjects received full per protocol therapy, completed all scheduled visits and had no substantial deviations from the protocol. Since PP-analysis and ITT-analysis demonstrated similar (confirmative) results the results of PP-analysis are presented.||Percentage of participants|||Number
663469|NCT01804881|Secondary|Change in Weight|Weight was recorded at baseline and after 6 weeks. There are fewer participants recorded in this secondary outcome measure (11 and 10 vs.13 and 12 in previous, main, outcome measure) because some participants did not want to be re-weighed.|6 weeks|Intention to Treat analysis||kg||Standard Deviation|Mean
663470|NCT01804881|Secondary|Change in Blood Pressure|Blood Pressure was recorded at baseline and after 6 weeks. There are fewer participants recorded in this secondary outcome measure (11 and 10 vs.13 and 12 in previous, main, outcome measure) because some participants did not want to have blood pressure taken again.|6 weeks|Intention to Treat analysis||mm Hg||Standard Deviation|Mean
663471|NCT01804881|Primary|The Change in EEQ (Emotional Eater Questionnaire) Score is the Primary Outcome Measure in This Study.|"The EEQ is a10-item validated questionnaire measuring the degree of interaction between food intake and emotion. Scores on a scale between baseline score and score after 6 weeks was measured.
The EEQ is scored as follows:
Values: Never = ‘0’; Sometimes = ‘1’; Generally = ‘2’; Always = ‘3’ Score between 0-5: “You are a non-emotional eater. Score between 6-10: “You are a low emotional eater. Score between 11-20: “You are an emotional eater. Score between 21-30: “You are a very emotional eater. The participants completed the EEQ at baseline and it was scored. After 6 weeks the participants completed the EEQ again and it was scored again. The participants' baseline score was compared to the score at week 6. The goal was for scores to reduce. If participants' scores were higher at week 6, that could mean that the intervention was not successful. If the participants' scores were lower at week 6, that could mean that the intervention was successful."|6 weeks|Intention to Treat analysis||Scores on a scale||Standard Deviation|Mean
663485|NCT01804673|Secondary|Time Spent Out of the Bed Per Day by the Participant|Participants were asked to enter the time in hours spend out of bed during the last 24 hours in the participant diary.|Baseline to Hour 24, Hour 24 to Hour 48 and Hour 48 to Hour 72|Efficacy analysis set included all participants who received the study treatment at least once and who had efficacy data for primary parameter after 0 hour Baseline visit. 'N' (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies participants evaluable for this measure at specified time point.||minutes||Standard Deviation|Mean
663476|NCT01804673|Secondary|Post-Operative Phase (PPP33) Quality of Life Questionnaire Score|The PPP33 questionnaire has an overall score and 8 subscales that represent different aspects of the post-operative quality of life: information, autonomy, communication, physical complaints, pain, rest, fear and accommodation. Answers to individual question are scored with values 1 to 4. Summary scores are calculated by adding values for each question. Subscores ranges depend on the number of questions evaluated (2 to 7 questions). The overall score ranges from 1 to 100. Higher scores indicate less pain.|Hour 72|Efficacy analysis set included all participants who received the study treatment at least once and who had efficacy data for the primary parameter after the 0 hour Baseline visit. 'N' (number of participants analyzed) signifies those participants evaluable for this measure.||units on scale||Standard Deviation|Mean
663477|NCT01804673|Secondary|Comprehensibility of the Information Material (IM): Participant Questionnaire Responses|Participants were asked to evaluate the IM for IONSYS by responding to following questions of a questionnaire: A- Is IONSYS easy to use, B- Were you able to operate the system by yourself after receiving instructions, C- Have you found button yourself, D- Was pressing button easy, E- Have you heard system’s beeps, F- Was IONSYS IM easy to understand, G- Did IM help you to use system, H- Did you have problems falling asleep, I- Could you move easily in bed, J- Did system bother you during physiotherapy, K- Do you perceive use of such system as modern treatment standard.|Hour 72|Efficacy analysis set included all participants who received the study treatment at least once and who had efficacy data for primary parameter after 0 hour Baseline visit.||percent of participants|||Number
663478|NCT01804673|Secondary|Comprehensibility of the Information Material (IM): Nursing Staff Questionnaire Responses|Nursing staff were asked to evaluate the IM for IONSYS by responding to following questions of a questionnaire: IM A- Was IM easy to understand, B- Did IM help you to use system properly; IONSYS PCA A- Is system easy to handle, B- Did participant need help in using system, C- Do you feel confident using IONSYS; IV PCA- Are you experienced in using IV PCA; IONSYS PCA D- Could participant get mobilized sooner, E- Does participant move more, F- Is participant less afraid of moving, G- Were hospital logistics for IONSYS easier to handle.|Hour 72|Efficacy analysis set included all participants who received the study treatment at least once and who had efficacy data for primary parameter after 0 hour Baseline visit.||percent of participants|||Number
663479|NCT01804673|Secondary|Comprehensibility of the Information Material (IM): Physician Questionnaire Responses|Physicians were asked to evaluate the IM for fentanyl-ITS (IONSYS) by responding to following questions of a questionnaire: Part2 D- Would you use IONSYS again, E- Would you prefer IONSYS to intravenous patient controlled analgesia (IV PCA); Part3 A- Was IM easy to understand, B- Did IM help you to use system properly.|Hour 72|Efficacy analysis set included all participants who received the study treatment at least once and who had efficacy data for primary parameter after 0 hour Baseline visit. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||percent of participants|||Number
663480|NCT01804673|Secondary|Physician's Evaluation of Participant's Ability to Undergo Physiotherapy or Mobilization|Physicians were asked to rate the participant’s ability to undergo physiotherapy or mobilization by responding to following questions of a questionnaire: Part 1 A- Does the surgical procedure performed allow the mobilization of the participant, C- Was the mobilization of the participant limited due to pain, D- Is the participant in a condition to undergo physiotherapy; Part 2 A- Was it possible to mobilize the participant sooner than with other pain therapies, B- Does the participant move more, C- Is the participant less afraid of moving. For Part 1-Question C, ‘Partial’ indicates that mobilization of participant was moderately limited due to pain.|Hours 24, 48 and 72|Efficacy analysis set included all participants who received the study treatmentat least once and who had efficacy data for primary parameter after 0 hour Baseline visit. ‘n’ signifies participants evaluable at specified time point for specified item.||percent of participants|||Number
663481|NCT01804673|Secondary|Percentage of Participants With Nursing Staff Global Assessment of Pain|Nursing Staff were asked to give their overall global assessment of pain therapy with study treatment using a 4-point verbal rating scale (poor, fair, good, excellent). Outcome of 'good' or 'excellent ' was recorded as Response while outcome of 'poor' or 'fair' was recorded as No response.|Hours 24, 48 and 72|Efficacy analysis set included all participants who received the study treatment at least once and who had efficacy data for primary parameter after 0 hour Baseline visit. ‘n’ signifies those participants evaluable for this measure at the specified time point.||percent of participants||95% Confidence Interval|Number
663482|NCT01804673|Secondary|Percentage of Participants With Physician Global Assessment of Pain|Physicians were asked to give their overall global assessment of pain therapy with study treatment using a 4-point verbal rating scale (poor, fair, good, excellent). Outcome of 'good' or 'excellent ' was recorded as Response while outcome of 'poor' or 'fair' was recorded as No response.|Hours 24, 48 and 72|Efficacy analysis set included all participants who received the study treatment at least once and who had efficacy data for primary parameter after 0 hour Baseline visit. ‘n’ signifies those participants evaluable for this measure at the specified time point.||percent of participants||95% Confidence Interval|Number
663483|NCT01804673|Secondary|Percentage of Participants With Global Assessment of Pain at Hour 48 and 72|Participants were asked to give their overall global assessment of pain therapy with study treatment using a 4-point verbal rating scale (poor, fair, good, excellent). Outcome of 'good' or 'excellent ' was recorded as Response while outcome of 'poor' or 'fair' was recorded as No response.|Hours 48 and 72|Efficacy analysis set included all participants who received the study treatment at least once and who had efficacy data for primary parameter after 0 hour Baseline visit. 'N' (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies participants evaluable for this measure at specified time point.||percent of participants||95% Confidence Interval|Number
663484|NCT01804673|Secondary|Time to Mobilization|Participants were asked to describe their time schedule for particular steps of mobilization by answering specific questions in the participant diary.|Baseline, Hours 24, 48 and 72|Data was not statistically summarized but reported in individual participant listing. Due to excessive missing data it was not possible to calculate valid results for the different stages of mobilization.|||||
663500|NCT01804062|Primary|Mean Error (ME) +/- 1 Breath Per Minute, RR Sensor|The software shall calculate respiration rate values via Adult Respiratory Sensor with a mean error of +/- 1 breath per minute relative to a capnography based reference.|up to 40 minutes of continous monitoring|||BrPM||Standard Deviation|Mean
663486|NCT01804673|Secondary|Change From Baseline in Pain Intensity Rating at Hour 24, 48 and 72|Nursing staff asked the participants to rate their current pain intensity on 11-point NRS (range 0 to 10, 0= no pain; 10= strongest pain imaginable).|Baseline, Hour 24, 48 and 72|Efficacy analysis set included all participants who received the study treatment at least once and who had efficacy data for primary parameter after 0 hour Baseline visit. 'N' (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies participants evaluable for this measure at specified time point.||units on scale||Standard Deviation|Mean
663487|NCT01804673|Secondary|Number of Hours Per Day With Average Pain Intensity Less Than or Equal to 4|Number of hours per day with average pain intensity less than or equal to 4 was measured on a 11-point Numeric Rating Scale (NRS) (range 0 to 10, 0=no pain; 4=mild pain; 10=strongest pain imaginable). If the participant was sleeping at time of measurement, pain intensity was assumed to be less than or equal to 4.|Baseline to Hour 24, Hour 24 to Hour 48 and Hour 48 to Hour 72|Efficacy analysis set included all participants who received the study treatment at least once and who had efficacy data for the primary parameter after 0 hour Baseline visit. 'N' (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies participants evaluable for this measure at specified time point.||hours||Standard Deviation|Mean
663488|NCT01804673|Primary|Percentage of Participants With Global Assessment of Pain at Hour 24|Participants were asked to rate their overall global assessment of pain therapy with study treatment on a 4-point verbal rating scale (poor, fair, good, excellent). Outcome of 'good' or 'excellent ' was recorded as Response while outcome of 'poor' or 'fair' was recorded as No response.|Hour 24|Efficacy analysis set included all participants who received the study treatment at least once and who had efficacy data for the primary parameter after the 0 hour Baseline visit.||percent of participants||95% Confidence Interval|Number
663489|NCT01804257|Other Pre-specified|User Experience|Feedback and suggestions from patients, caregivers, and healthcare providers regarding system metrics and summary presentations of medication-taking, biometrics, and activities of daily living. Feedback includes free text and descriptive statistics summarizing numeric scores collected from a standardized instrument focusing on overall satisfaction with the DHFS and its components.|4 weeks||||||
663490|NCT01804257|Other Pre-specified|Usability|Characterize, using summary (descriptive) statistics, the use of the digital health feedback system and its components by patients, caregivers, and healthcare providers. Use captured utilizing numeric scores collected from a standardized instrument, focusing on overall comfort and ease of DHFS use.|4 weeks||||||
663491|NCT01804257|Other Pre-specified|Biometrics|Characterize, using summary (descriptive) statistics, heart rate and rest/activity patterns in a free-living environment. Activity defined as the number of hours per day with recorded a recorded step rate ≥ 60 steps per minute|4 weeks||||||
663492|NCT01804257|Other Pre-specified|Taking and Scheduling Adherence|Characterize, using summary (descriptive) statistics, medication-taking behavior in free-living environment. Taking adherence defined as the number of ingestion sensors detected by the DHFS in the free-living environment, divided by the prescribed (planned) number of ingestions. Scheduling adherence defined as number of ingestion sensors detected by the DHFS within a ± 2-hour time window around the prescribed (planned) dosing time, divided by the total number of ingestion sensors detected by the DHFS.|4 weeks||||||
663493|NCT01804257|Secondary|System Safety|Characterize, using summary (descriptive) statistics, the incidence and nature of system-related adverse events (AEs) and serious adverse events (SAEs) that are reported by study investigators over the course of the study|8 weeks||||||
663494|NCT01804257|Primary|Positive Detection Accuracy|Comparison of the detection rate of sensor-enabled placebo tablet ingestion using wireless observation (wirelessly observed therapy) to directly observed ingestion. Positive detection accuracy (PDA) for wirelessly observed therapy defined as the number of sensor ingestions detected by wireless observation, divided by the number confirmed ingestions using direct observation. PDA summarized as mean and 95% confidence interval.|4 weeks|28 individuals with bipolar disorder (12) or schizophrenia (16)||percentage of observed ingestions||95% Confidence Interval|Mean
663495|NCT01804140|Primary|Number of Participants Classified Based on Different Types of BRAF V600 Mutation Patterns in Tumor Samples|FFPEs tumor samples (at least 5 serially-cut, unstained, 5 μm sections) were collected from eligible participants who consented to participate in the study. FFPE tumor samples were either from archived sections (from the initial diagnosis of cancer) or from fresh biopsies that were performed according to local standards. Tumor samples were then sent to a central laboratory to identify activating BRAF V600 mutations. Identification of mutations was done using bidirectional direct Sanger sequencing procedure. V600E, V600K, V600D, and V600R are the different types of BRAF V600 mutations.|Up to 1 year|All the participants who were enrolled and were evaluable for the BRAF V600 mutations were included in the analysis.||participants|||Number
663496|NCT01804140|Primary|Percentage of Participants With BRAF V600 Mutation Positivity in Tumor Samples by Cancer Type|Formalin-fixed paraffin-embedded (FFPEs) tumor samples (at least 5 serially-cut, unstained, 5 micrometer [μm] sections) were collected from eligible participants who consented to participate in the study. FFPE tumor samples were either from archived sections (from the initial diagnosis of cancer) or from fresh biopsies that were performed according to local standards. Tumor samples were then sent to a central laboratory to identify activating BRAF V600 mutations. Identification of mutations was done using bidirectional direct Sanger sequencing procedure.|Up to 1 year|All the participants who were enrolled and were evaluable for the BRAF V600 mutations were included in the analysis. n is the number of participants with that type of cancer in the total population.||percentage of participants||95% Confidence Interval|Number
663497|NCT01804075|Secondary|Second Drug for Withdrawal|Number of infants treated with a second drug to treat their withdrawal|From date of randomization until the date of last opioid dose or date of death from any cause or date of discharge, whichever came first, assessed up to 12 months|||Participants|||Count of Participants
663498|NCT01804075|Primary|Days of Treatment With Opioid Medication|The length of time in days that the treatment opioid was used on a measured taper to ameliorate withdrawal signs|From date of randomization until the date of last opioid dose or date of death from any cause, whichever came first, assessed up to 12 months|||days||Standard Deviation|Mean
663499|NCT01804062|Secondary|ME +/- 1 Breath Per Minute, Max-N Sensor|The software shall calculate respiration rate values via Max-N with a mean error of +/- 1 breath per minute relative to a capnography based reference.|up to 40 minutes of continuous monitoring|||BrPM||Standard Deviation|Mean
663501|NCT01804036|Secondary|Mindfulness Assessment (Five-facet Mindfulness Questionnaire; FFMQ)|This is a validated questionnaire which tracks how facets of mindfulness may develop over time. It has 39 items and divides into 5 factors representing the various aspects of mindfulness. The range is 0-195. The greater the value the greater an individual's mindfulness level.|Baseline, 2 month follow up|||units on a scale||95% Confidence Interval|Mean
663502|NCT01804036|Secondary|Connor-Davidson Resilience Scale (CD-RISC)|One of the few well-validated measures of resilience is the Connor-Davidson Resilience Scale (CD-RISC), comprising 25 items. All items are summed to obtain a CD-RISC total score ranging from 0–100, with greater total scores indicating greater resilience.|Baseline, 2 month follow up|||units on a scale||95% Confidence Interval|Mean
663503|NCT01804036|Secondary|Center for Epidemiologic Studies Depression Scale (CES-D)|The CES-D is one of the most commonly validated screening tests for helping an individual to determine his or her depression quotient. The 20-item test measures depressive feelings and behaviors during the past week. Each item is summed to obtain a CES-D total score ranging from 0 to 60; higher scores indicate more severe depressive symptoms. A total score of 16 or higher was identified in early studies as indicative of individuals with depressive illness.|Baseline, 2 month follow up|||units on a scale||95% Confidence Interval|Mean
663504|NCT01804036|Secondary|PTSD Check List (PCL) - Military (PCL-M)|The PCL-M is a well-validated 17-item self-report measure to assess PTSD severity among military personnel; both male and female, to assess military-related PTSD. Reliability evidence is very good. Items are based on DSM criteria (DSM-IV criteria for this version) and are rated on a 5-point Likert-type scale that allows the derivation of a quantifiable total score.Range is 0-85, the greater the value the worse the PTSD reported symptoms.|Baseline, 2 month follow up|||units on a scale||95% Confidence Interval|Mean
663505|NCT01804036|Primary|Change in Waking After Sleep Onset Using a Sleep Diary, From Baseline at 2 Month Follow-up|Sleep Diary - 7 days of data collection; Waking After Sleep Onset (WASO, in min.): The duration of awakenings throughout the night, calculated after falling asleep to before the last awakening of waking up and not going back to sleep. Range 0 - 24 hr. A negative value reflects improvement in WASO at the 2-month follow-up.|Baseline, 2 month follow up|||minutes||95% Confidence Interval|Mean
663506|NCT01804036|Primary|Change in Waking After Sleep Onset Using a Sleep Diary, From Baseline at 1-week Follow-up|Sleep Diary - 7 days of data collection; Waking After Sleep Onset (WASO, in min.): The duration of awakenings throughout the night, calculated after falling asleep to before the last awakening of waking up and not going back to sleep. Range 0 - 24 hr. A negative value reflects improvement in WASO at the 1-week follow-up.|Baseline, 1-week follow up|||minutes||95% Confidence Interval|Mean
663507|NCT01804036|Primary|Change in Sleep Onset Latency Using a Sleep Diary, From Baseline at 2 Month Follow-up|Sleep Diary - 7 days of data collection; Sleep Onset Latency (SOL, in min.): The time to fall asleep, calculated from the time of turning out the light to falling asleep. Range 0 - 24 hr. A negative value reflects an improvement in SOL at the 2-month follow-up.|Baseline, 2 month follow up|||minutes||95% Confidence Interval|Mean
663508|NCT01804036|Primary|Change in Sleep Onset Latency Using a Sleep Diary, From Baseline at 1-week Follow-up|Sleep Diary - 7 days of data collection; Sleep Onset Latency (SOL, in min.): The time to fall asleep, calculated from the time of turning out the light to falling asleep. Range 0 - 24 hr. A negative value reflects an improvement in SOL at the 1-week follow-up.|Baseline, 1-week follow up|||minutes||95% Confidence Interval|Mean
663509|NCT01804036|Primary|Change in Total Sleep Time Using a Sleep Diary, From Baseline at 2 Month Follow-up|Sleep Diary - 7 days of data collection; Total Sleep Time (TST, in min.): The amount of time asleep, calculated from the time of falling asleep to waking up. Range 0 - 24 hr. The greater the value the more total sleep was obtained.|Baseline, 2 month follow up|||minutes||95% Confidence Interval|Mean
663510|NCT01804036|Primary|Change in Total Sleep Time Using a Sleep Diary, From Baseline at 1-week Follow-up|Sleep Diary - 7 days of data collection. Total Sleep Time (TST, in min.): The amount of time asleep, calculated from the time of falling asleep to waking up. Range 0 - 24 hr. The greater the value the more total sleep was obtained.|Baseline, 1-week follow up|||minutes||95% Confidence Interval|Mean
663511|NCT01804036|Primary|Change in Insomnia Severity Index, From Baseline at 2 Month Follow-up|Insomnia Severity Index - A 7-item validated questionnaire evaluating severity of insomnia symptoms over the past 7 days. The total score is reported with a range of 0-28. The greater the value the greater the insomnia severity. In the present study, the greater the change from baseline the greater the improvement in insomnia severity.|Baseline, 2 month follow up|||units on a scale||95% Confidence Interval|Mean
663512|NCT01804036|Primary|Change in Insomnia Severity Index, From Baseline at 1-week Follow-up|Insomnia Severity Index - A 7-item validated questionnaire evaluating severity of insomnia symptoms over the past 7 days. The total score is reported with a range of 0-28. The greater the value the greater the insomnia severity. In the present study, the greater the change from baseline the greater the improvement in insomnia severity.|Baseline, 1-week follow up|||units on a scale||95% Confidence Interval|Mean
663513|NCT01804036|Primary|Change in Subjective Measures of Sleep Using Medical Outcomes Study -Sleep Scale, From Baseline at 2 Month Follow-up|Medical Outcomes Study - sleep scale. A 12-item validated questionnaire evaluating sleep outcomes over the past 7 days. The subscale Sleep Problems Index - II, is reported, range is 0-100. The greater the value the worse the sleep problems. In the present study, the greater the change from baseline the greater the improvement in sleep problems.|Baseline, 2 month follow up|||units on a scale||95% Confidence Interval|Mean
663514|NCT01804036|Primary|Change in Subjective Measures of Sleep Using Medical Outcomes Study -Sleep Scale, From Baseline at 1-week Follow-up|Medical Outcomes Study - sleep scale. A 12-item validated questionnaire evaluating sleep outcomes over the past 7 days. The subscale Sleep Problems Index - II, is reported, range is 0-100. The greater the value the worse the sleep problems. In the present study, the greater the change from baseline the greater the improvement in sleep problems.|Baseline, 1-week follow up|||units on a scale||95% Confidence Interval|Mean
663515|NCT01803737|Secondary|Autonomous and Controlled Motivation|At week 12, participants completed the 13-item TSRQ to assess motivation to continue to participate in the program if given the opportunity. The TSRQ represents participants’ reasons for continuing participation in a weight loss program via participants’ endorsement of statements of autonomous and controlled motivation. Responses were given using a 7-point Likert scale (1 = not at all true to 7 = very true). The responses on the autonomous items (5) and controlled items (8) were averaged.|Week 12|||units on a scale||Standard Deviation|Mean
663516|NCT01803737|Secondary|Change in Weight Loss Self-efficacy|Self-efficacy for weight loss was assessed at week 0 and 12 using a 20-item Weight Efficacy Lifestyle Questionnaire (WEL). The total score ranges from 0-180. Higher values represent greater beliefs toward the completion of weight management behaviors.|Week 0 and 12|||units on a scale||Standard Deviation|Mean
663517|NCT01803737|Secondary|Completion of Self-monitoring of Dietary Intake and Physical Activity|The frequency that participants engaged in the self-monitoring of dietary intake and physical activity was assessed at week 12. The diaries were completed weekly throughout the study.|Week 0 and 12|||percentage of diaries completed|Participants|Standard Deviation|Mean
663518|NCT01803737|Secondary|Change in Dietary Intake: % Carbohydrate|A questionnaire will be used to assess self-reported food intake. This will be used to estimate calories, dietary fat, protein, and carbohydrates consumed.|Week 0 and 12|||percentage of carbohydrate intake||Standard Deviation|Mean
663519|NCT01803737|Secondary|Change in Dietary Intake: % Protein|A questionnaire will be used to assess self-reported food intake. This will be used to estimate calories, dietary fat, protein, and carbohydrates consumed.|Week 0 and 12|||percentage of protein intake||Standard Deviation|Mean
663520|NCT01803737|Secondary|Change in Dietary Intake: % Fat|A questionnaire will be used to assess self-reported food intake. This will be used to estimate calories, dietary fat, protein, and carbohydrates consumed.|Week 0 and 12|||percentage of fat intake||Standard Deviation|Mean
663521|NCT01803737|Secondary|Change in Dietary Intake: Kcals/Day|A questionnaire will be used to assess self-reported food intake. This will be used to estimate calories, dietary fat, protein, and carbohydrates consumed.|Week 0 and 12|||kcals/day||Standard Deviation|Mean
663522|NCT01803737|Secondary|Change in Physical Activity|A questionnaire will be used to measure and quantify energy expenditure from physical activity.|Week 0 and 12|||kcals/wk||Standard Deviation|Mean
663523|NCT01803737|Primary|Change in Body Weight|Body weight will be measured on a digital scale to assess change in body weight over the 12-week intervention period.|Week 0 and 12|||kg||Standard Deviation|Mean
663524|NCT01803607|Secondary|Change From Baseline in Serum N-terminal Propeptide of Type 1 Collagen (s-P1NP)|s-P1NP is a biochemical marker of bone resorption. s-P1NP was measured and expressed as ng/mL at Baseline and Month 12, and results are expressed as percentage change from baseline.|Baseline and Month 12|The PP population includes all participants who received 1 dose of study drug, had the necessary baseline and post-baseline data, and did not have any protocol violations that may substantially impact results||Percentage Change from Baseline||Standard Error|Geometric Mean
663525|NCT01803607|Secondary|Change From Baseline in Serum Bone Specific Alkaline Phosphatase (s-BSAP)|s-BSAP is a biochemical marker of bone resorption. s-BSAP was measured and expressed in ng/mL at Baseline and Month 12, and results are shown as percentage change from baseline.|Baseline and Month 12|The PP population includes all participants who received 1 dose of study drug, had the necessary baseline and post-baseline data, and did not have any protocol violations that may substantially impact results||Percentage Change from Baseline||Standard Error|Geometric Mean
663526|NCT01803607|Secondary|Change From Baseline in Urine N-telopeptides of Type 1 Collagen Corrected for Creatinine (u-NTx/Cr)|The u-NTx/Cr ratio is a biochemical marker of bone resorption. u-NTx/Cr was measured at baseline and Month 12 and expressed in nM:mM and results are expressed as percentage change from baseline.|Baseline and Month 12|The PP population includes all participants who received 1 dose of study drug, had the necessary baseline and post-baseline data, and did not have any protocol violations that may substantially impact results.||Percentage Change from Baseline||Standard Error|Geometric Mean
663527|NCT01803607|Secondary|Change From Baseline in Urine C-telopeptides of Type I Collagen (u-CTx)|u-CTx is a biochemical marker of bone resorption. At baseline and Month 12, u-CTx was measured and expressed in ug/mL and results are expressed as percentage change from baseline.|Baseline and Month 12|The PP population includes all participants who received 1 dose of study drug, had the necessary baseline and post-baseline data, and did not have any protocol violations that may substantially impact results.||Percentage Change from Baseline||Standard Error|Geometric Mean
663528|NCT01803607|Secondary|Change From Baseline in Serum C-telopeptides of Type 1 Collagen (s-CTx)|s-CTx is a biochemical marker of bone resorption. At baseline and Month 12, s-CTx was measured and expressed in ng/mL and results are expressed as percentage change from baseline.|Baseline and Month 12|The Per Protocol (PP) population includes all participants who received 1 dose of study drug, had the necessary baseline and post-baseline data, and did not have any protocol violations that may substantially impact results.||Percent Change from Baseline||Standard Error|Geometric Mean
663529|NCT01803607|Secondary|Percent Change From Baseline to Month 12 in Trochanter, Total Hip, and Lumbar Spine BMD|DXA was used to determine the change from baseline in trochanter, total hip, and lumbar spine BMD at Month 12.|Baseline and Month 12|The FAS includes all randomized participants who took at least one dose of study medication and had the relevant baseline and follow-up measurements||Percentage Change from Baseline||Standard Error|Mean
663530|NCT01803607|Secondary|Percent Change From Baseline to Month 24 in Femoral Neck BMD: Within-Group Comparison of Odanacatib|DXA was used to determine the within-group change from baseline in femoral neck BMD at Month 24.|Baseline and Month 24|The trial was terminated prematurely, thus this analysis was not conducted.|||||
663531|NCT01803607|Primary|Percent Change From Baseline to Month 12 in Femoral BMD|Dual-energy X-ray absorptiometry (DXA) was used to determine the change from baseline in femoral neck BMD at Month 12.|Baseline and Month 12|The Full Analysis set (FAS) includes all randomized participants who took at least one dose of study medication and had the relevant baseline and follow-up measurements.||Percent Change from Baseline||Standard Error|Mean
663539|NCT01802554|Secondary|Positive and Negative Affect Schedule|This scales contains ten items assessing Positive Affect. Items included are adjectives, such as “interested,” “strong,” and “inspired”. Participants rated each adjective based on how they felt over the past few weeks using a 5-point scale with responses ranging from 1 (very slightly to not at all) to 5 (extremely). The scale's minimum score is 10 and maximum score is 50. Higher scores represent better outcomes.|Change from Baseline Positive Affect at 8-weeks|||units on a scale||Standard Error|Mean
663567|NCT01801982|Primary|Number of Participants With Clinically Significant Medical History at Month 24|Criteria for clinically significant medical history included any hospital admissions or any medications given since discharge from Study A1481276 (NCT01069861) that were considered clinically significant by the investigator.|Month 24|Data was not possible to report as participant lost to follow-up at Month 24 (Visit 2) after Month 12 follow-up (Visit 1).|||||
663532|NCT01802632|Secondary|Best Objective Response (BOR) for 80mg AZD9291 Extension Population|Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions; Stable disease (SD): Neither sufficient shrinkage to qualify as a response nor sufficient growth to qualify as progression; Progressive Disease (PD): >= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of >=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. Not evaluable (NE): TL response is missing and there is no evidence of progression of NTLs and no new lesions. BOR is the best response (by investigator assessment) a patient has achieved where the order of best to worst is CR, PR, SD, PD, NE prior to or at progression and prior to further anti-cancer therapy.|RECIST tumour assessments every 6 weeks from randomisation until objective disease progression, up to approximately 12 months (at the time of analysis)|All patients in the 80mg AZD9291 extension part of the study (second line or later, EGFR T790M mutation positive by central testing) who received at least one dose of AZD9291 and had measurable disease (by investigator assessment) at baseline.||% of participants|||Number
663533|NCT01802632|Primary|Objective Response Rate (ORR) for Extension Population|Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. ORR is the percentage of patients with at least 1 visit response of CR or PR (by independent central review) that was confirmed at least 4 weeks later, prior to progression or further anti-cancer therapy.|RECIST tumour assessments every 6 weeks from randomisation until objective disease progression, up to approximately 12 months (at the time of analysis)|All patients in the 80mg AZD9291 extension part of the study (second line or later, EGFR T790M mutation positive by central testing) who received at least one dose of AZD9291 and had measurable disease (by independent central review) at baseline.||% of participants||95% Confidence Interval|Number
663534|NCT01802632|Secondary|Progression-Free Survival (PFS) for Dose Expansion Population|Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Progressive Disease (PD): >= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of >=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. PFS is the time from date of first dose until the date of PD (by independent central review) or death (by any cause in the absence of progression) regardless of whether the patient withdrew from AZD9291 therapy or received another anti-cancer therapy prior to progression. Patients who had not progressed or died at the time of analysis were censored at the time of the latest date of assessment from their last evaluable RECIST 1.1 assessment.|RECIST tumour assessments every 6 weeks from randomisation until objective disease progression, up to approximately 21 months (at time of analysis)|All pre-treated EGFR T790M mutation positive (by central testing) patients who received at least one dose of AZD9291.||months||95% Confidence Interval|Median
663535|NCT01802632|Secondary|Duration of Response (DoR) for Dose Expansion Population|Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. DoR was defined as the time from the date of first documented response (CR or PR that was subsequently confirmed) until the date of documented progression (PD) or death in the absence of disease progression (by investigator assessment).|RECIST tumour assessments every 6 weeks from randomisation until objective disease progression, up to approximately 21 months (at time of analysis)|All pre-treated EGFR T790M mutation positive (by central testing) patients who received at least one dose of AZD9291.||months||95% Confidence Interval|Median
663536|NCT01802632|Primary|Best Objective Response (BOR) for Dose Escalation Population|Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions; Stable disease (SD): Neither sufficient shrinkage to qualify as a response nor sufficient growth to qualify as progression; Progressive Disease (PD): >= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of >=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. Not evaluable (NE): TL response is missing and there is no evidence of progression of NTLs and no new lesions. BOR is the best response (by investigator assessment) a patient has achieved where the order of best to worst is CR, PR, SD, PD, NE prior to or at progression and prior to further anti-cancer therapy.|RECIST tumour assessments every 6 weeks from randomisation until objective disease progression, up to approximately 25 months (at time of analysis)|All pre-treated EGFR T790M mutation positive (by central testing) patients who received at least one dose of AZD9291.||% of participants|||Number
663537|NCT01802632|Primary|Objective Response Rate (ORR) for Dose Expansion Population|Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. ORR is the percentage of patients with at least 1 visit response of CR or PR (by investigator assessment) that was confirmed at least 4 weeks later, prior to progression or further anti-cancer therapy.|RECIST tumour assessments every 6 weeks from randomisation until objective disease progression, up to approximately 21 months (at time of analysis)|All pre-treated EGFR T790M mutation positive (by central testing) patients who received at least one dose of AZD9291.||% of participants||95% Confidence Interval|Number
663538|NCT01802554|Secondary|Positive and Negative Affect Schedule|This scales contains ten items assessing Negative Affect. Items included are adjectives, such as “distressed,” “ashamed,” and Participants rated each adjective based on how they felt over the past few weeks using a 5-point scale with responses ranging from 1 (very slightly to not at all) to 5 (extremely). The scale's minimum score is 10 and maximum score is 50. Lower scores represent better outcomes.|Change from Baseline Negative Affect at 8-weeks|||units on a scale||Standard Error|Mean
663566|NCT01801982|Secondary|Overall Survival at Month 12|Overall survival was the duration from enrollment to death. For participants who are alive, overall survival was censored at the last contact. Number of participants who were alive at Month 12 was to be reported.|Month 12|Full Analysis Set (FAS) included all enrolled participants.||participants|||Number
663540|NCT01802554|Primary|Interleukin-6 (IL-6)|IL-6 is one of many biomarkers represented in the inflammatory cascade which is initiated during an immune response. Prospectively, increased plasma IL-6 is also associated with future myocardial infarction in healthy men and increasing concentrations of IL-6 have been associated with both nonfatal myocardial infarction and fatal Coronary Heart Disease (CHD) in longitudinal studies of population-based cohorts. Higher concentrations of IL-6 raise CHD risk. Blood was collected by a research nurse in the caregivers’ homes through a 22-gauge forearm catheter after a 20 min rest. Blood for IL-6 was dispensed in Ethylenediaminetetraacetic acid (EDTA) tubes and spun at 3000 g for 10 minutes at 4 to 8 degrees Celsius. Obtained plasma was stored at minus 80 degrees Celsius until analyzed. Plasma IL-6 (Meso Scale Discovery, Gaithersburg, MD) was determined via highsensitive enzyme-linked immunosorbent assays. Intra- and interassay coefficients of variation were less than 5 percent.|Change from Baseline IL-6 at 8-weeks|||pg/ml||Standard Error|Mean
663541|NCT01802554|Primary|D-dimer|D-dimer is an indicator of fibrin formation and its subsequent lysis and is a useful biomarker representing overall activation of blood coagulation. High concentrations of D-dimer have been linked prospectively to onset of Coronary Heart Disease. Blood was collected by a research nurse in the caregivers’ homes through a 22 gauge forearm catheter after a 20 minute rest. Blood for D-dimer was dispensed into polypropylene tubes with 3.8 percent sodium citrate and spun at 1600 g for 10 minutes at room temperature. Obtained plasma was stored at minus 80 degrees Celsius until analyzed. Plasma D-dimer (Asserachrom Stago, Asnieres, France) was determined via high sensitive enzyme-linked immunosorbent assays. Intra- and interassay coefficients of variation were less than 5 percent.|Change from Baseline D-dimer at 8-weeks|||ng/ml||Standard Error|Mean
663542|NCT01802554|Primary|Brief Center for Epidemiologic Studies Depression Scale (CESD)|The Brief CESD is a measure of depressive symptoms. The scale's minimum score is 0 and maximum score is 30. Lower scores represent fewer depressive symptoms and thus better outcomes.|Change from Baseline CESD at 8-weeks|||units on a scale||Standard Error|Mean
663543|NCT01802515|Secondary|Change Score in the Center for Epidemiological Studies-Depression (CES-D) Scale|Center for Epidemiological Studies-Depression. The CES-D is a 20-item self-report measure of depressive symptoms. Each of the 20 items can yield a score from 0 to 3 for a maximum total CES-D score of 60. Larger values represent more severe symptoms. It is a validated instrument with a score of 16 or more indicating clinically significant depression. The CES-D change score was computed as (total baseline CES-D score - total CES-D score at end of study).|8 weeks of treatment|Descriptive statistics were calculated for all enrolled subjects. A full statistical analysis was not performed due to study termination.||units on a scale||Standard Deviation|Mean
663544|NCT01802515|Primary|Treatment Retention|The number of participants completing all 8 weeks of treatment phase.|8 weeks of treatment|Descriptive statistics were calculated for all enrolled subjects. A full statistical analysis was not performed due to study termination.||participants|||Number
663545|NCT01802320|Secondary|Validation of the Enrichment Biomarker Signature in Metastatic Sites|Samples will be analyzed using the Wilcoxon rank test. Chi-square or Fisher’s exact test where appropriate will be used to determine whether high levels of marker expression correlate with PTEN status.|Up to 18 months||||||
663546|NCT01802320|Secondary|Progression-free Survival (PFS)|Estimated using the Kaplan and Meier product limit method. Cox proportional hazards regression model will be used to identify prognostic factors for PFS.|From start of treatment to time of progression or death, whichever occurs first, assessed up to 18 months||||||
663547|NCT01802320|Secondary|Overall Survival (OS)|Estimated using the Kaplan and Meier product limit method. Cox proportional hazards regression model will be used to identify prognostic factors for OS.|Up to 18 months||||||
663548|NCT01802320|Secondary|Duration of Tumor Response (DR)|Estimated using the Kaplan and Meier product limit method. Cox proportional hazards regression model will be used to identify prognostic factors for DR.|From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 18 months|Outcome data not collected, no analysis to be performed as participants had related tumor response.|||||
663549|NCT01802320|Primary|Overall Response Rate (CR+PR) Evaluated Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1|Complete Response (CR): Disappearance all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. Partial Response (PR): > 30% decrease in sum diameters of target lesions, reference baseline sum diameters. Progressive Disease (PD): > 20% increase in sum diameters of target lesions, reference smallest sum on study (includes baseline sum if smallest on study). In addition to relative increase of 20%, sum must demonstrate absolute increase of >5 mm. (Note: appearance of 1/> new lesions also considered progressions). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum diameters while on study.|Up to 18 months|||Participants|||Count of Participants
663550|NCT01802151|Primary|Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires|Gastrointestinal Symptom Questionaires (GSRS) was administered during weeks 1, 5, and 6 of the study to evaluate gastrointestinal symptoms. The scale ranges from 1 (no discomfort at all) to 7 (very severe discomfort).|Weeks 1, 5, and 6|Participants who completed all study requirements were included in the baseline analysis population.||units on a scale||Standard Error|Mean
663551|NCT01802151|Primary|Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Hours of Sleep|Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Participants recorded the number of hours they slept on the daily questionnaire.|Weekly for 6 weeks|Participants who completed all study requirements were included in the baseline analysis population.||Hours||Standard Error|Mean
663552|NCT01802151|Primary|Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Bowel Movement|Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Daily scores from weeks 2 - 5 were then averaged to arrive at a single value. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).|Weekly for 6 weeks|Participants who completed all study requirements were included in the baseline analysis population.||units on a scale||Standard Error|Mean
663553|NCT01802151|Primary|Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Satiety|Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).|Weekly for 6 weeks|Participants who completed all study requirements were included in the baseline analysis population.||units on a scale||Standard Error|Mean
663554|NCT01802151|Primary|Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Fatigue|Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).|Weekly for 6 weeks|Participants who completed all study requirements were included in the baseline analysis population.||units on a scale||Standard Error|Mean
663555|NCT01802151|Primary|Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Diarrhea|Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).|Weekly for 6 weeks|Participants who completed all study requirements were included in the baseline analysis population.||units on a scale||Standard Error|Mean
663556|NCT01802151|Primary|Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Constipation|Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).|Weekly for 6 weeks|Participants who completed all study requirements were included in the baseline analysis population.||units on a scale||Standard Error|Mean
663557|NCT01802151|Primary|Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Emetic|Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).|Weekly for 6 weeks|Participants who completed all study requirements were included in the baseline analysis population.||units on a scale||Standard Error|Mean
663558|NCT01802151|Primary|Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Behavioral|Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).|Weekly for 6 weeks|Participants who completed all study requirements were included in the baseline analysis population.||units on a scale||Standard Error|Mean
663559|NCT01802151|Primary|Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Ear, Nose, and Throat (ENT)|Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).|Weekly for 6 weeks|Participants who completed all study requirements were included in the baseline analysis population.||units on a scale||Standard Error|Mean
663560|NCT01802151|Primary|Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Epidermal|Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).|Weekly for 6 weeks|Participants who completed all study requirements were included in the baseline analysis population.||units on a scale||Standard Error|Mean
663561|NCT01802151|Primary|Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Cephalic|Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).|Weekly for 6 weeks|Participants who completed all study requirements were included in the baseline analysis population.||units on a scale||Standard Error|Mean
663562|NCT01802151|Secondary|Evaluation of the Survival of B. Subtilis R0179 and Analyzing the Microbial Diversity in Stool Samples by Participants (Microbiota Study)|Viability of B. subtilis R0179, recovered from stool samples, was assessed using one way ANOVA followed subsequently by Tukey-Kramer HSD when significance was reached (p<0.05). Data was normalized when appropriate. Data analyzed was log (CFU/g).|6 weeks|Participants who completed all study requirements were included in the baseline analysis population.||log CFU/g||Standard Error|Mean
663563|NCT01802151|Primary|Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for GI Distress|Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).|Weekly for 6 weeks|Participants who completed all study requirements were included in the baseline analysis population.||units on a scale||Standard Error|Mean
663564|NCT01801982|Secondary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Up to Month 12|FAS included all enrolled participants.||participants|||Number
663565|NCT01801982|Secondary|Overall Survival at Month 24|Overall survival was the duration from enrollment to death. For participants who are alive, overall survival was censored at the last contact. Number of participants who were alive at Month 24 was to be reported.|Month 24|Data was not possible to report as participant lost to follow-up at Month 24 (Visit 2) after Month 12 follow-up (Visit 1).|||||
666038|NCT01763905|Secondary|Percent Change From Baseline in Lipoprotein (a) at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
663568|NCT01801982|Primary|Number of Participants With Clinically Significant Medical History at Month 12|Criteria for clinically significant medical history included any hospital admissions or any medications given since discharge from Study A1481276 (NCT01069861) that were considered clinically significant by the investigator.|Month 12|Full Analysis Set (FAS) included all enrolled participants.||participants|||Number
663569|NCT01801982|Primary|Number of Participants With Physical Examination Abnormalities at Month 24|Physical examinations included height, weight, head circumference, general appearance, skin examination, abdominal examination, respiratory system, neurological examination, hearing and ophthalmology assessments. Physical examination abnormalities were based on investigator discretion.|Month 24|Data was not possible to report as participant lost to follow-up at Month 24 (Visit 2) after Month 12 follow-up (Visit 1).|||||
663570|NCT01801982|Primary|Number of Participants With Physical Examination Abnormalities at Month 12|Physical examinations included height, weight, head circumference, general appearance, skin examination, abdominal examination, respiratory system, neurological examination, hearing and ophthalmology assessments. Physical examination abnormalities were based on investigator discretion.|Month 12|Full Analysis Set (FAS) included all enrolled participants.||participants|||Number
663571|NCT01801735|Primary|Safety of Meloxicam 10 mg as Assessed by the Incidence of Adverse Events From Baseline to Week 52 or Early Termination|The safety of Meloxicam 10 mg was assessed by the number of subjects with treatment-emergent adverse events (TEAEs), severe TEAEs, serious adverse events, treatment-related TEAEs, and adverse events (AEs) leading to discontinuation and subjects who died.|Baseline to Week 52/Early Termination|||participants|||Number
663572|NCT01801475|Primary|Metabolic Clearance of Ondasetron|This is a mathematical estimation of the clearance for ondasetron as calculated by NONMEM.|8 hours for women; 48 hours for neonate.|All patient data was used in the estimation process.||L/hr||95% Confidence Interval|Mean
663573|NCT01801475|Primary|Volume of Distribution Estimated Pharmacokinetic Parameter|This is an estimated pharmacokinetic parameter as calculated by NONMEM.|8 hours for women; 48 hours for neonate.|All subjects but not possible for neonates||Liters||95% Confidence Interval|Mean
663574|NCT01801436|Primary|Volume of Distribution at Steady-State (Vss) of Bortezomib on Day 11 of Cycle 1|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state which is estimated by (D/AUC[0-infinity])*(AUMC[0-infinity])/AUC[0-infinity]) where D is the dose of study drug, AUMC(0-infinity) is the area under the first moment curve extrapolated to infinity and AUC(0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time.|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 11 of Cycle 1|The PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.||Liter||Standard Deviation|Mean
663575|NCT01801436|Primary|Volume of Distribution at Steady-State (Vss) of Bortezomib on Day 1 of Cycle 1|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state which is estimated by (D/AUC[0-infinity])*(AUMC[0-infinity])/AUC[0-infinity]) where D is the dose of study drug, AUMC(0-infinity) is the area under the first moment curve extrapolated to infinity and AUC(0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time.|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 1 of Cycle 1|The PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.||Liter||Standard Deviation|Mean
663576|NCT01801436|Primary|Systemic Clearance (CL) of Bortezomib on Day 11 of Cycle 1|Systemic CL is a quantitative measure of the rate at which a drug substance is removed from the body. The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by the plasma AUC(0-infinity).|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 11 of Cycle 1|The PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.||Liter per Hour||Standard Deviation|Mean
663577|NCT01801436|Primary|Systemic Clearance (CL) of Bortezomib on Day 1 of Cycle 1|Systemic CL is a quantitative measure of the rate at which a drug substance is removed from the body. The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by the plasma AUC(0-infinity).|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 1 of Cycle 1|The PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.||Liter per Hour||Standard Deviation|Mean
663578|NCT01801436|Primary|Mean Residence Time (MRT) of Bortezomib in the Body on Day 11 of Cycle 1|The MRT is the average time at which the number of absorbed molecules reside in the body, after single-dose administration, and calculated as AUMC(infinity)/AUC(infinity) where AUMC(infinity) is area under the plasma concentration-time first moment curve from time zero to infinite time and AUC(infinity) is the area under the plasma concentration-time curve from time zero to infinite time.|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 11 of Cycle 1|PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.||Hour||Standard Deviation|Mean
663579|NCT01801436|Primary|Mean Residence Time (MRT) of Bortezomib in the Body on Day 1 of Cycle 1|The MRT is the average time at which the number of absorbed molecules reside in the body, after single-dose administration, and calculated as AUMC(infinity)/AUC(infinity) where AUMC(infinity) is area under the plasma concentration-time first moment curve from time zero to infinite time and AUC(infinity) is the area under the plasma concentration-time curve from time zero to infinite time.|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 1 of Cycle 1|The PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.||Hour||Standard Deviation|Mean
666039|NCT01763905|Secondary|Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
663580|NCT01801436|Primary|Area Under First Moment Plasma Concentration-Time Curve (AUMC) of Bortezomib on Day 11 of Cycle 1|AUMC is defined as the area under first moment plasma concentration-time curve from time of dosing up to definite time t, to infinity, or to the time of last measurable concentration determined by the following equation: AUMC(0 to infinity)=Cntn/k elimination(el) + Cn/k(el^2) summation[(tn – tn^-1) (Cn^-1) (tn^-1)] + Cntn/2 where Cn=last quantifiable concentration, tn=time at which Cn is measured, k=rate constant.|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 11 of Cycle 1|The PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.||Hour square*ng per ml||Standard Deviation|Mean
663581|NCT01801436|Primary|Area Under First Moment Plasma Concentration-Time Curve (AUMC) of Bortezomib on Day 1 of Cycle 1|AUMC is defined as the area under first moment plasma concentration-time curve from time of dosing up to definite time t, to infinity, or to the time of last measurable concentration determined by the following equation: AUMC(0 to infinity)=Cntn/k elimination(el) + Cn/k(el^2) summation[(tn – tn^-1) (Cn^-1) (tn^-1)] + Cntn/2 where Cn=last quantifiable concentration, tn=time at which Cn is measured, k=rate constant.|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 1 of Cycle 1|The PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.||Hour square*ng per ml||Standard Deviation|Mean
663582|NCT01801436|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of Bortezomib on Day 11 of Cycle 1|The AUC(0-infinity) is area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z), in which C(last) is the last observed quantifiable concentration.|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 11 of Cycle 1|The PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.||Hour*ng per ml||Standard Deviation|Mean
663583|NCT01801436|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of Bortezomib on Day 1 of Cycle 1|The AUC(0-infinity) is area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z), in which C(last) is the last observed quantifiable concentration.|Day 1 of Cycle 1|The PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.||Hour*ng per ml||Standard Deviation|Mean
663584|NCT01801436|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to Time at Last Observed Quantifiable Concentration (AUC[0-t]) of Bortezomib on Day 11 of Cycle 1|The AUC(0-t) is area under the plasma concentration-time curve from zero to the last quantifiable concentration determined by the trapezoidal rule.|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 11 of Cycle 1|The PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.||Hour*ng per mL||Standard Deviation|Mean
663585|NCT01801436|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to Time at Last Observed Quantifiable Concentration (AUC[0-t]) of Bortezomib on Day 1 of Cycle 1|The AUC(0-t) is area under the plasma concentration-time curve from time zero to the last quantifiable concentration determined by the trapezoidal rule.|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 1 of Cycle 1|PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.||Hour*ng per ml||Standard Deviation|Mean
663586|NCT01801436|Primary|Terminal Rate Constant (Lambda[z]) of Bortezomib on Day 11 of Cycle 1|Lambda(z) is defined as terminal rate-constant which reflect the speed of drug elimination in vivo (within the living), and is estimated by log-linear regression analysis of the terminal phase of the plasma concentration versus time curve for at least 3 points.|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 11 of Cycle 1|The PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.||Per Hour||Standard Deviation|Mean
663587|NCT01801436|Primary|Terminal Rate Constant (Lambda[z]) of Bortezomib on Day 1 of Cycle 1|Lambda(z) is defined as terminal rate-constant which reflect the speed of drug elimination in vivo (within the living), and is estimated by log-linear regression analysis of the terminal phase of the plasma concentration versus time curve for at least 3 points.|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 1 of Cycle 1|The PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.||Per Hour||Standard Deviation|Mean
663588|NCT01801436|Primary|Elimination Half-Life Period (T1/2) of Bortezomib on Day 11 of Cycle 1|The T1/2 is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal rate-constant (lambda[z]) of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 11 of Cycle 1|The PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.||Hours||Standard Deviation|Mean
663589|NCT01801436|Primary|Elimination Half-Life Period (T1/2) of Bortezomib on Day 1 of Cycle 1|The T1/2 is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal rate-constant (lambda[z]) of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 1 of Cycle 1|The PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.||Hours||Standard Deviation|Mean
663675|NCT01800318|Secondary|Change in Salivary Cortisol After Heel Stick|Salivary cortisol was obtained prior to initiation of heelstick procedure, and at 5±0.5 minutes after procedure by gentle insertion in the mouth of a soft applicator (Salimetrics Infant Swab). The samples were stored at -20 degrees, and were analyzed at UAMS.|Baseline and 5±0.5 minutes after heel stick|||ng/ml||Standard Deviation|Mean
663590|NCT01801436|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Bortezomib on Day 11 of Cycle 1|Tmax is the time when Cmax is observed, taken directly from the plasma concentration-time profile.|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 11 of Cycle 1|The PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.||Hours||Standard Deviation|Mean
663591|NCT01801436|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Bortezomib on Day 1 of Cycle 1|Tmax is the time when Cmax is observed, taken directly from the plasma concentration-time profile.|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 1 of Cycle 1|The PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.||Hours||Standard Deviation|Mean
663592|NCT01801436|Primary|Maximum Observed Plasma Concentration (Cmax) of Bortezomib on Day 11 of Cycle 1|The Cmax is observed maximum plasma concentration, taken directly from the plasma concentration-time profile.|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 11 of Cycle 1|The PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.||ng per ml||Standard Deviation|Mean
663593|NCT01801436|Primary|Maximum Observed Plasma Concentration (Cmax) of Bortezomib on Day 1 of Cycle 1|The Cmax is observed maximum plasma concentration, taken directly from the plasma concentration-time profile.|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 1 of Cycle 1|The Per-protocol (PP) population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.||Nanogram per millileter (ng per ml)||Standard Deviation|Mean
663594|NCT01801436|Primary|Number of Participants With KPS Score at Day 11 of Cycle 8|The KPS Index allows participants to be classified as per their functional impairment (abnormal function). This can be used to compare effectiveness of different therapies (medicine or medical care given to a participant for a disease or condition) and to assess the prognosis (outlook, probable outcomes) in individual participants. KPS was recorded on an 11-point scale (0, 10, 20, 30, 40, 50, 60, 70, 80, 90, and 100.) where '0=Dead' and '100=Normal, no complaints, no evidence of disease'. The lower the Karnofsky score, the worse the survival for most serious illnesses.|Day 11 of Cycle 8|The FAS population included all the participants who received 1 dose of study medication and had post-dose efficacy data.||Participants|||Number
663595|NCT01801436|Primary|Number of Participants With KPS Score at Day 1 of Cycle 7|The KPS Index allows participants to be classified as per their functional impairment (abnormal function). This can be used to compare effectiveness of different therapies (medicine or medical care given to a participant for a disease or condition) and to assess the prognosis (outlook, probable outcomes) in individual participants. KPS was recorded on an 11-point scale (0, 10, 20, 30, 40, 50, 60, 70, 80, 90, and 100.) where '0=Dead' and '100=Normal, no complaints, no evidence of disease'. The lower the Karnofsky score, the worse the survival for most serious illnesses.|Day 1 of Cycle 7|The FAS population included all the participants who received 1 dose of study medication and had post-dose efficacy data. Here ‘N’ signifies those participants who were evaluated for this outcome measures.||Participants|||Number
663596|NCT01801436|Primary|Number of Participants With KPS Score at Day 1 of Cycle 5|The KPS Index allows participants to be classified as per their functional impairment (abnormal function). This can be used to compare effectiveness of different therapies (medicine or medical care given to a participant for a disease or condition) and to assess the prognosis (outlook, probable outcomes) in individual participants. KPS was recorded on an 11-point scale (0, 10, 20, 30, 40, 50, 60, 70, 80, 90, and 100.) where '0=Dead' and '100=Normal, no complaints, no evidence of disease'. The lower the Karnofsky score, the worse the survival for most serious illnesses.|Day 1 of Cycle 5|The FAS population included all the participants who received 1 dose of study medication and had post-dose efficacy data. Here ‘N’ signifies those participants who were evaluated for this outcome measures.||Participants|||Number
663597|NCT01801436|Primary|Number of Participants With KPS Score at Day 1 of Cycle 3|The KPS Index allows participants to be classified as per their functional impairment (abnormal function). This can be used to compare effectiveness of different therapies (medicine or medical care given to a participant for a disease or condition) and to assess the prognosis (outlook, probable outcomes) in individual participants. KPS was recorded on an 11-point scale (0, 10, 20, 30, 40, 50, 60, 70, 80, 90, and 100.) where '0=Dead' and '100=Normal, no complaints, no evidence of disease'. The lower the Karnofsky score, the worse the survival for most serious illnesses.|Day 1 of Cycle 3|The FAS population included all the participants who received 1 dose of study medication and had post-dose efficacy data. Here ‘N’ signifies those participants who were evaluated for this outcome measures.||Participants|||Number
663598|NCT01801436|Primary|Number of Participants With KPS Score at Day 1 of Cycle 1|The KPS Index allows participants to be classified as per their functional impairment (abnormal function). This can be used to compare effectiveness of different therapies (medicine or medical care given to a participant for a disease or condition) and to assess the prognosis (outlook, probable outcomes) in individual participants. KPS was recorded on an 11-point scale (0, 10, 20, 30, 40, 50, 60, 70, 80, 90, and 100.) where '0=Dead' and '100=Normal, no complaints, no evidence of disease'. The lower the Karnofsky score, the worse the survival for most serious illnesses.|Day 1 of Cycle 1|The FAS population included all the participants who received 1 dose of study medication and had post-dose efficacy data.||Participants|||Number
663599|NCT01801436|Primary|Number of Participants With Karnofsky Performance Status (KPS) Score at Baseline|The KPS Index allows participants to be classified as per their functional impairment (abnormal function). This can be used to compare effectiveness of different therapies (medicine or medical care given to a participant for a disease or condition) and to assess the prognosis (outlook, probable outcomes) in individual participants. KPS was recorded on an 11-point scale (0, 10, 20, 30, 40, 50, 60, 70, 80, 90, and 100.) where '0=Dead' and '100=Normal, no complaints, no evidence of disease'. The lower the Karnofsky score, the worse the survival for most serious illnesses.|Baseline|The FAS population included all the participants who received 1 dose of study medication and had post-dose efficacy data.||Participants|||Number
664014|NCT01791894|Primary|Percent Change in Biomarker (GLI2 Protein) Levels||baseline to day 33|We recruited patients with biopsy-confirmed metastatic basal cell carcinoma who were had progressed on SMO inhibitors such as vismodegib (GDC 0449), IPI- 926, LEQ506 and LDE225.||percentage decrease||Standard Deviation|Mean
663600|NCT01801436|Primary|Number of Participants With Response to Treatment at Day 11 of Cycle 8|Response to treatment was based on the changes in monoclonal protein (M-protein) in serum and urine. Response categories were complete response: complete clearance of M-protein for at least 6 weeks, response: at least 75 percent reduction in M-protein for at least 2 determinations 6 weeks apart, partial response: 50 to 74 percent reduction in M-protein, minimal response: 25 to 49 percent reduction in M-protein, stable disease: not qualifying minimal response or progression and progression: increased M-protein level in serum or urine or clinical signs of disease progression.|Day 11 of Cycle 8|The FAS population included all the participants who received 1 dose of study medication and had post-dose efficacy data.||Participants|||Number
663601|NCT01801436|Primary|Number of Participants With Response to Treatment at Day 1 of Cycle 7|Response to treatment was based on the changes in monoclonal protein (M-protein) in serum and urine. Response categories were complete response: complete clearance of M-protein for at least 6 weeks, response: at least 75 percent reduction in M-protein for at least 2 determinations 6 weeks apart, partial response: 50 to 74 percent reduction in M-protein, minimal response: 25 to 49 percent reduction in M-protein, stable disease: not qualifying minimal response or progression and progression: increased M-protein level in serum or urine or clinical signs of disease progression.|Day 1 of Cycle 7|The FAS population included all the participants who received 1 dose of study medication and had post-dose efficacy data. Here ‘N’ signifies those participants who were evaluated for this outcome measures.||Participants|||Number
663602|NCT01801436|Primary|Number of Participants With Response to Treatment at Day 1 of Cycle 5|Response to treatment was based on the changes in monoclonal protein (M-protein) in serum and urine. Response categories were complete response: complete clearance of M-protein for at least 6 weeks, response: at least 75 percent reduction in M-protein for at least 2 determinations 6 weeks apart, partial response: 50 to 74 percent reduction in M-protein, minimal response: 25 to 49 percent reduction in M-protein, stable disease: not qualifying minimal response or progression and progression: increased M-protein level in serum or urine or clinical signs of disease progression.|Day 1 of Cycle 5|The full analysis set (FAS) population included all the participants who received 1 dose of study medication and had post-dose efficacy data. Here ‘N’ signifies those participants who were evaluated for this outcome measures.||Participants|||Number
663603|NCT01801358|Secondary|Phase lb: PK Parameters for MEK162 - Tmax (Cycle 1; Day 15)|Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.|Cycle 1 (Day 15)|This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data.||hr||Full Range|Median
663604|NCT01801358|Secondary|Phase lb: PK Parameters for MEK162 - Cmax (Cycle 1; Day 15)|Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.|Cycle 1 (Day 15)|This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data.||ng/ml||Geometric Coefficient of Variation|Geometric Mean
663605|NCT01801358|Secondary|Phase Ib: PK Parameters for MEK162 - AUC0-8hr (Cycle 1; Day 15)|Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.|Cycle 1 (Day 15)|This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data.||hr*ng/ml||Geometric Coefficient of Variation|Geometric Mean
663606|NCT01801358|Secondary|Phase lb: PK Parameters for MEK162 - Tmax (Cycle 1; Day 1)|Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.|Cycle 1 (Day 1)|This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data.||hr||Full Range|Median
663607|NCT01801358|Secondary|Phase lb: PK Parameters for MEK162 - Cmax (Cycle 1; Day 1)|Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.|Cycle 1 (Day 1)|This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data.||ng/ml||Geometric Coefficient of Variation|Geometric Mean
663608|NCT01801358|Secondary|Phase Ib: PK Parameters for MEK162 - AUC0-8hr (Cycle 1; Day 1)|Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.|Cycle 1 (Day 1)|This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data.||hr*ng/ml||Geometric Coefficient of Variation|Geometric Mean
663609|NCT01801358|Secondary|Phase lb: PK Parameters for AEB071 - Tmax (Cycle 1; Day 15)|Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.|Cycle 1 (Day 15)|This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data.||hr||Full Range|Median
663610|NCT01801358|Secondary|Phase lb: PK Parameters for AEB071 - Cmax (Cycle 1; Day 15)|Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.|Cycle 1 (Day 15)|This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data.||ng/ml||Geometric Coefficient of Variation|Geometric Mean
663611|NCT01801358|Secondary|Phase Ib: PK Parameters for AEB071 - AUC0-8hr (Cycle 1; Day 15)|Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.|Cycle 1 (Day 15)|This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data.||hr*ng/ml||Geometric Coefficient of Variation|Geometric Mean
663612|NCT01801358|Secondary|Phase lb: PK Parameters for AEB071 - Tmax (Cycle 1; Day 1)|Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.|Cycle 1 (Day 1)|This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data.||hr||Full Range|Median
663613|NCT01801358|Secondary|Phase lb: PK Parameters for AEB071 - Cmax (Cycle 1; Day 1)|Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.|Cycle 1 (Day 1)|This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data.||ng/ml||Geometric Coefficient of Variation|Geometric Mean
663614|NCT01801358|Secondary|Phase Ib: PK Parameters for AEB071 - AUC0-8hr (Cycle 1; Day 1)|Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.|Cycle 1 (Day 1)|This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data.||hr*ng/ml||Geometric Coefficient of Variation|Geometric Mean
663615|NCT01801358|Secondary|Phase II: Evaluation of Preliminary Anti-tumor Activity - Overall Survival (OS)|"Evaluation of the preliminary anti-tumor activity at the RP2D for AEB071 and MEK162 and at 45 mg BID for MEK162 alone.
Overall survival (OS) is defined as the time from date of randomization/start of treatment to date of death due to any cause.
Due to an enrollment halt, the Phase II part of the study was not conducted."|From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit)|Analysis group is comprised of the Full Analysis Set (FAS), which is all patients in the phase Ib part of the study who received at least one full or partial dose of AEB071 or MEK162.|||||
663616|NCT01801358|Secondary|Phase II: Evaluation of Preliminary Anti-tumor Activity - Duration of Response (DOR)|"Evaluation of the preliminary anti-tumor activity at the RP2D for AEB071 and MEK162 and at 45 mg BID for MEK162 alone.
Duration of Response is not reported, due to the enrollment halt, which occurred prior to Phase II of the study."|From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit)|Analysis group is comprised of the Full Analysis Set (FAS), which is all patients in the phase Ib part of the study who received at least one full or partial dose of AEB071 or MEK162.|||||
663617|NCT01801358|Secondary|Phase II: Evaluation of Preliminary Anti-tumor Activity - Best Overall Response (BOR)|"Evaluation of the preliminary anti-tumor activity at the RP2D for AEB071 and MEK162 and at 45 mg BID for MEK162 alone.
The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for Progressive Disease (PD) the smallest measurements recorded since the treatment started). In general, the patient's best response assignment will depend on the achievement of both measurement and confirmation criteria.
Due to an enrollment halt, the Phase II part of the study was not conducted."|From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit)|Analysis group is comprised of the Full Analysis Set (FAS), which is all patients in the phase Ib part of the study who received at least one full or partial dose of AEB071 or MEK162.|||||
663618|NCT01801358|Secondary|Phase II: Evaluation of Preliminary Anti-tumor Activity - Overall Response Rate (CR+PR)|"Evaluation of the preliminary anti-tumor activity at the RP2D for AEB071 and MEK162 and at 45 mg BID for MEK162 alone.
Overall response rate (ORR) is the proportion of patients with a best overall response of Complete Response (CR) or Partial Response (PR). This is also referred to as ‘Objective response rate’ in some protocols or publications.
Due to an enrollment halt, the Phase II part of the study was not conducted."|From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit)|Analysis group is comprised of the Full Analysis Set (FAS), which is all patients in the phase Ib part of the study who received at least one full or partial dose of AEB071 or MEK162.|||||
663619|NCT01801358|Secondary|Phase Ib: Assessment of The Preliminary Anti-tumor Activity - Progression Free Survival (PFS)|"Assessment of the preliminary anti-tumor activity of AEB071 and MEK162 in combination.
PFS is the time from date of randomization/start of treatment to the date of event defined as the first documented progression or death due to any cause."|Cycle 1 (up to 28 days)|Analysis group is comprised of the Full Analysis Set (FAS), which is all patients in the phase Ib part of the study who received at least one full or partial dose of AEB071 or MEK162.||weeks||Inter-Quartile Range|Median
663620|NCT01801358|Secondary|Phase Ib: Assessment of The Preliminary Anti-tumor Activity - Duration of Response (DOR)|"Assessment of the preliminary anti-tumor activity of AEB071 and MEK162 in combination.
Duration of Response (DOR) is not reported, since there were no responses of Complete Response (CR) or Partial Response (PR) at any time during the study."|Cycle 1 (up to 28 days)|Analysis group is comprised of the Full Analysis Set (FAS), which is all patients in the phase Ib part of the study who received at least one full or partial dose of AEB071 or MEK162.|||||
663621|NCT01801358|Secondary|Phase Ib: Assessment of The Preliminary Anti-tumor Activity - Best Overall Response (BOR)|"Assessment of the preliminary anti-tumor activity of AEB071 and MEK162 in combination.
The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started). In general, the patient's best response assignment will depend on the achievement of both measurement and confirmation criteria."|Cycle 1 (up to 28 days)|Analysis group is comprised of the Full Analysis Set (FAS), which is all patients in the phase Ib part of the study who received at least one full or partial dose of AEB071 or MEK162.||participants|||Number
663622|NCT01801358|Secondary|Phase Ib/II: The Number of Subjects Experiencing At Least One Serious Adverse Event (SAE)|"Serious adverse event (SAE) is defined as one of the following:
Is fatal or life-threatening
Results in persistent or significant disability/incapacity
Constitutes a congenital anomaly/birth defect
Is medically significant
Requires inpatient hospitalization or prolongation of existing hospitalization
Note that hospitalizations for the following reasons should not be reported as serious adverse events:
Routine treatment or monitoring of the studied indication, not associated with any deterioration in condition
Elective or pre-planned treatment for a pre-existing condition that is unrelated to metastatic uveal melanoma and has not worsened since signing the informed consent
Social reasons and respite care in the absence of any deterioration in the patient’s general condition"|From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit)|Analysis group is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.||participants|||Number
663623|NCT01801358|Secondary|Phase Ib/II: The Number of Subjects Experiencing At Least One Adverse Event (AE)|An adverse event is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient’s signed informed consent has been obtained.|From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit)|Analysis group consists of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.||participants|||Number
663624|NCT01801358|Primary|Phase II: Progression Free Survival (PFS)|"The time from date of randomization to the date of event defined as the first documented progression or death due to any cause.
Due to an enrollment halt, the Phase II part of the study was not conducted. The sponsor decided to permanently stop recruitment for the study prior to MTD determination."|From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit)||||||
663625|NCT01801358|Primary|Phase Ib: Incidence of Dose Limiting Toxicities (DLT) During the First Cycle|A DLT is defined as an adverse event or abnormal laboratory value as defined in the protocol that is assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first 28 days of treatment with AEB071 and MEK162.|Cycle 1 (up to 28 days)|Analysis is comprised of the Dose-determining Set, which is all patients from the safety set who either met the minimum exposure criterion below and had sufficient safety evaluations during Cycle 1, or discontinued earlier due to DLT during Cycle 1.||DLTs|||Number
663626|NCT01801280|Primary|Dose-normalized AUC of Mycophenolic Acid|"Bioavailability (12h AUC) of mycophenolic acid in renal transplant patients after administration of MMF+/-PAN and EC-MPS+/-PAN
For evaluation of pharmacokinetic and pharmacodynamic parameters blood will be collected before, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h after drug intake."|Study duration for each patient: 2 months. After 10-14 days of drug intake blood samples for PK/PD analysis will be collected. On the next day new treatment starts. There are 4 study visits at the study center. Duration will be approximately 12hours|||mg*h/L||Standard Deviation|Mean
663627|NCT01801124|Secondary|The Safety of EXPAREL Will be Assessed by the Occurrence of All Postsurgical AEs and SAEs Through Day 30.|Adverse events and serious adverse events through Day 30 will be examined in order to assess the safety of EXPAREL.|30 days|The analysis population comprised all enrolled subjects.||participants|||Number
663628|NCT01801124|Primary|The Effectiveness of Abdominal Analgesia From the Infiltration Into the TAP as Measured by the Subject's Overall Postsurgical Analgesic Use|The effectiveness of abdominal analgesia from the infiltration into the TAP as measured by the subject's overall postsurgical analgesic use in morphine equivalents (mg)|10 days|The analysis population comprised all enrolled subjects.||mg (morphine equivalents)||Standard Deviation|Mean
663629|NCT01801111|Secondary|Percentage of Participants With CNS Progression As Assessed by IRC Based on RECIST|CNS progression was defined as the percentage of participants who developed a new CNS lesion or have disease progression in pre-existing CNS lesions based on IRC review of radiographs by RECIST version 1.1. Progression was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study or absolute increase of at lease 5 mm, progression of existing non-target lesions, or presence of new lesion|Baseline; assessments every 8 week post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator; then survival follow-up; data until cutoff (18 August 2014) are reported, maximum 53 weeks|Safety population||percentage of participants|||Number
663630|NCT01801111|Secondary|Duration of Response in Participants With CNS Response (CR or PR) as Assessed by IRC Based on RANO|Duration of response in participants with CNS response was defined as the time from the first observation of a CNS response (CR or PR) until first observation of CNS progression or death from any cause based on IRC review of radiographs by RANO criteria. CR and PR were as defined in outcome 39. Progression was defined by any of the following: at least 25% increase in sum of products of diameters of measurable enhancing (measurable) lesions compared to best response after initiation of therapy (nadir), or screening if screening was nadir value on stable or increasing doses of corticosteroids; significant increase in T2/FLAIR non-enhancing lesions not caused by co-morbid events on stable or increasing doses of corticosteroids; Any new lesions; Clear progression of enhancing non-measurable disease. Clinical deterioration not attributable to other non-tumour causes. Duration of response was estimated by Kaplan-Meier method and 95% CI was assessed using method of Brookmeyer and Crowley.|Baseline; assessments every 8 week post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator; then survival follow-up; data until cutoff (18 August 2014) are reported, maximum 53 weeks|Safety population. Number of participants analyzed=participants with measurable CNS lesions at baseline who achieved a CNS response of CR or PR according to IRC.||months||95% Confidence Interval|Median
663668|NCT01800916|Primary|Degree of Leakage|"The degree of leakage is measured using a 4-point leakage scale developed by Coloplast A/S at every baseplate change.
The subjects had to tick off one of the following choices:
No leakage
Starting to leak
Leakage
Sudden Leakage"|one week|The subjects were randomized to one of nine possible treatment groups. Each group consisted of three equal periods in which the subjects tested two test products and the comparator product (SenSura 1-piece). An equal distribution among the three arms and nine different treatment groups was aimed for. The ITT population was used for the analysis.||percentage of baseplates with no leakage|baseplates||Number
663631|NCT01801111|Secondary|Duration of Response in Participants With CNS Response (CR or PR) as Assessed by IRC Based on RECIST|Duration of response in participants with CNS response was defined as the time from the first observation of a CNS response (CR or PR) until first observation of CNS progression or death from any cause based on IRC review of radiographs by RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the screening sum diameters) and no progression of target lesions. Progression was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study or absolute increase of at lease 5 mm, progression of existing non-target lesions, or presence of new lesion. Duration of response was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley.|Baseline; assessments every 8 week post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator; then survival follow-up; data until cutoff (18 August 2014) are reported, maximum 53 weeks|Safety population. Number of participants analyzed=participants with measurable CNS lesions at baseline and who achieved a CNS response of CR or PR according to IRC.||months||95% Confidence Interval|Median
663632|NCT01801111|Secondary|Percentage of Participants Achieving Objective Response (CR or PR) of Baseline Central Nervous System (CNS) Lesions As Assessed by IRC Based on Radiology Assessment in Neuro-Oncology (RANO) Criteria|Objective response (CR and PR) of CNS lesions was assessed based on IRC review of radiographs by RANO criteria. CR was achieved if all of the following criteria met: Complete disappearance of all enhancing measurable and non-measurable disease; Stable or improved non-enhancing (T2/FLAIR) lesions; No new lesions; Participant must be off corticosteroids (or on physiologic replacement doses only), and clinically stable or improved. PR was achieved if all of the following criteria met: at least 50% decrease compared with screening in the sum of the products of the diameters (SPD) of measurable enhancing measurable lesions; No progression of non-measurable disease (enhancing and non-enhancing [T2/FLAIR] lesions); No new lesions; Participant must be off corticosteroids (or on physiologic replacement doses only), and clinically stable or improved. For both CR and PR, responses had to be sustained for at least 4 weeks.|Baseline; assessments every 8 week post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator; then survival follow-up; data until cutoff (18 August 2014) are reported, maximum 53 weeks|Safety population. Number of participants analyzed=participants with measurable CNS lesions at baseline according to IRC.||percentage of participants||95% Confidence Interval|Number
663633|NCT01801111|Secondary|Percentage of Participants Achieving Objective Response (CR or PR) of Baseline Central Nervous System (CNS) Lesions As Assessed by IRC Based on RECIST|Objective response (CR and PR) of CNS lesions was assessed based on IRC review of radiographs by RECIST version 1.1 in participants with measurable CNS lesions at baseline. CR was defined as disappearance of all target and non-target lesions. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the screening sum diameters) and no progression of target lesions.|Baseline; assessments every 8 week post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator; then survival follow-up; data until cutoff (18 August 2014) are reported, maximum 53 weeks|Safety population. Number of participants analyzed=participants measurable CNS lesions at baseline according to IRC.||percentage of participants||95% Confidence Interval|Number
663634|NCT01801111|Secondary|Percentage of Participants Achieving CR, PR or Stable Disease (SD, Lasting ≥16 Weeks) in Response Evaluable Population|Disease control (CR,PR or SD) was measured by RECIST version 1.1. by IRC and Investigator. CR was defined as disappearance of all target, non-target lesions; normalization of tumor marker level and all lymph nodes size is <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters). SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.|Baseline; every 8 week post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reasons deemed by the investigator, or data cutoff (18 August 2014, maximum follow up 53 weeks)|RE population. Here, 'n' signifies participants with measurable disease at baseline for specified category.||percentage of participants||95% Confidence Interval|Number
663635|NCT01801111|Secondary|Overall Survival (OS)|OS was defined as the time from the date of first treatment to the date of death, regardless of the cause of death. OS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley.|Baseline up to death (any cause) or data cutoff (18 August 2014, maximum follow up 53 weeks)|Safety population||months||95% Confidence Interval|Median
663636|NCT01801111|Primary|Percentage of Participants Achieving Objective Response (CR or PR) as Assessed by IRC in Chemotherapy-Pretreated Participants|Objective response was assessed by IRC according to RECIST version 1.1. CR was defined as disappearance of all target, non-target lesions; normalization of tumor marker level and all lymph nodes size was <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters). CR and PR was to be confirmed by repeat assessments ≥4 weeks after initial documentation.|Baseline; assessments every 8 week post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator; then survival follow-up; data until cutoff (18 August 2014) are reported, maximum 53 weeks|RE population (IRC). Number of participants analyzed=participants from RE population (IRC) who received prior chemotherapy.||percentage of participants||95% Confidence Interval|Number
663637|NCT01801111|Secondary|Percentage of Participants Who Died||Baseline up to death (any cause) or data cut off (18 August 2014, maximum follow up 53 weeks)|Safety population||percentage of participants|||Number
663669|NCT01800903|Primary|Overall Discomfort During Catheterization|Evaluated by the subject on a 10 cm Visual Analog Scale (VAS), where 0 cm is no discomfort and 10 cm is the worst possible discomfort.|1 day|||cm||Standard Deviation|Mean
663670|NCT01800890|Primary|Degree of Leakage|"The degree of leakage is assessed using a 4 point leakage scale developed by Coloplast A/S.
The 4-point leakage scale has four choices
No leakage
Starting to leakage
Leakage
Sudden leakage
Leakage was assessed at every baseplate change"|10 days|||units on a scale|Participants|Standard Deviation|Mean
663638|NCT01801111|Primary|Percentage of Participants Achieving Objective Response (Complete Response [CR] or Partial Response [PR]) as Assessed by Independent Radiological Review Committee (IRC) in Response Evaluable (RE) Population|Objective response was assessed by IRC according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. CR was defined as disappearance of all target, non-target lesions; normalization of tumor marker level and all lymph nodes size was <10 millimeter (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters). CR and PR was to be confirmed by repeat assessments ≥4 weeks after initial documentation.|Baseline; assessments every 8 week post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator; then survival follow-up; data until cutoff (18 August 2014) are reported, maximum 53 weeks|RE population (IRC): all participants with measurable disease at baseline according to the IRC, who had baseline tumor assessment and received at least one dose of alectinib.||percentage of participants||95% Confidence Interval|Number
663639|NCT01801111|Primary|Area Under the Plasma Concentration Time Curve From Time 0 to 10 Hour Post-dose (AUC[0-10]) of Alectinib||Day 1 and Day 21 of Cycle 1|Data for this endpoint was not collected, as planned, because Part I of this study was not conducted.|||||
663640|NCT01801111|Secondary|Progression Free Survival (PFS)|PFS was defined as the time interval between the date of the first treatment and the date of progression or death from any cause, whichever occurred first. Progression (according to RECIST version 1.1) was defined as at least a 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study or absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesion. Progression was assessed by IRC and by the investigator in safety population as well as in subgroups of participants who received prior chemotherapy and who did not receive prior chemotherapy. PFS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley.|Baseline; assessments every 8 week post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator; then survival follow-up; data until cutoff (18 August 2014) are reported, maximum 53 weeks|"Safety population. Here, n signifies the number of participants evaluable for specified category."||months||95% Confidence Interval|Median
663641|NCT01801111|Secondary|Percentage of Participants With Progression or Death|Progression (according to RECIST version 1.1) was defined as at least a 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study or absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesion. Progression was assessed by IRC and by the investigator in safety population as well as in subgroups of participants who received prior chemotherapy and who did not received prior chemotherapy.|Baseline; assessments every 8 week post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator; then survival follow-up; data until cutoff (18 August 2014) are reported, maximum 53 weeks|"Safety population. Here, n signifies the number of participants evaluable for specified category."||percentage of participants|||Number
663642|NCT01801111|Secondary|Duration of Response|Duration of response was defined as the time from the first observation of an objective tumor response until first observation of disease progression using RECIST version 1.1 or death from any cause. Duration of response was estimated by Kaplan-Meier method and 95% confidence interval (CI) was assessed using the method of Brookmeyer and Crowley. Duration of response was assessed by IRC and by investigator as well as in subgroups of participants who received prior chemotherapy and who did not received prior chemotherapy.|Baseline; assessments every 8 week post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator; then survival follow-up; data until cutoff (18 August 2014) are reported, maximum 53 weeks|RE population: participants with measurable disease at baseline, had baseline tumor assessment and received at least one dose of alectinib. Number of participants analyzed= participants with measurable disease at baseline and had objective response. n=participants with measurable disease at baseline and had objective response for specified category||months||95% Confidence Interval|Median
663643|NCT01801111|Secondary|Percentage of Participants Achieving Objective Response (CR or PR) as Assessed by Investigator in Chemotherapy-Naive Participants|Objective response was assessed by investigator according to RECIST version 1.1. CR was defined as disappearance of all target, non-target lesions; normalization of tumor marker level and all lymph nodes size was <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters). CR and PR was to be confirmed by repeat assessments ≥4 weeks after initial documentation.|Baseline; assessments every 8 week post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator; then survival follow-up; data until cutoff (18 August 2014) are reported, maximum 53 weeks|RE population (investigator). Number of participants analyzed=participants from RE population (investigator) who did not receive prior chemotherapy.||percentage of participants||95% Confidence Interval|Number
663644|NCT01801111|Secondary|Percentage of Participants Achieving Objective Response (CR or PR) as Assessed by Investigator in Chemotherapy-Pretreated Participants|Objective response was assessed by investigator according to RECIST version 1.1. CR was defined as disappearance of all target, non-target lesions; normalization of tumor marker level and all lymph nodes size was <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters). CR and PR was to be confirmed by repeat assessments ≥4 weeks after initial documentation.|Baseline; assessments every 8 week post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator; then survival follow-up; data until cutoff (18 August 2014) are reported, maximum 53 weeks|RE population (investigator). Number of participants analyzed=participants from RE population (investigator) who received prior chemotherapy.||percentage of participants||95% Confidence Interval|Number
663671|NCT01800786|Primary|Overnight Change in Declarative Memory Performance|"At 3 months, we compared average overnight changes between evening and morning performance on a declarative memory test between untreated OSA subjects and those who received CPAP therapy for 3 months.
Positive numbers represent an increase in performance."|3 months|||percent change in performance||Standard Deviation|Mean
663672|NCT01800318|Secondary|Duration of Crying During Heel Stick|Any crying during the heel stick procedure was timed in seconds.|5 minutes +/- 2 minutes|Newborn infants during heel stick procedure, crying timed in seconds||seconds||Standard Deviation|Mean
663645|NCT01801111|Secondary|Percentage of Participants Achieving Objective Response (CR or PR) as Assessed by Investigator in Response Evaluable Population|Objective response was assessed by investigator according to RECIST version 1.1. CR was defined as disappearance of all target, non-target lesions; normalization of tumor marker level and all lymph nodes size was <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters). CR and PR was to be confirmed by repeat assessments ≥4 weeks after initial documentation.|Baseline; assessments every 8 week post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator; then survival follow-up; data until cutoff (18 August 2014) are reported, maximum 53 weeks|RE population (Investigator): all participants with measurable disease at baseline according to the investigator, who had baseline tumor assessment and received at least one dose of alectinib.||percentage of participants||95% Confidence Interval|Number
663646|NCT01801111|Secondary|Percentage of Participants Achieving Objective Response (CR or PR) as Assessed by IRC in Chemotherapy-Naive Participants|Objective response was assessed by IRC according to RECIST version 1.1. CR was defined as disappearance of all target, non-target lesions; normalization of tumor marker level and all lymph nodes size was <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters). CR and PR was to be confirmed by repeat assessments ≥4 weeks after initial documentation.|Baseline; assessments every 8 week post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator; then survival follow-up; data until cutoff (18 August 2014) are reported, maximum 53 weeks|RE population (IRC). Number of participants analyzed=participants from RE population (IRC) who did not receive prior chemotherapy.||percentage of participants||95% Confidence Interval|Number
663647|NCT01801111|Primary|Percentage of Participants With Dose Limiting Toxicities (DLTs)|DLTs were to be assessed based on the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.3. DLTs: drug-related toxicities that meet any one of the following criteria: Grade 4 thrombocytopenia; Grade 3 thrombocytopenia with bleeding; Grade 4 neutropenia continuing for ≥7 consecutive days or neutropenic fever; Non-hematological toxicity of Grade 3 or higher; Adverse events that require interruption of treatment for a total of ≥7 days.|Cycle 1 (up to 28 days)|The endpoint was not analyzed in this study as the RP2D was confirmed in study NP28761 (NCT01871805).|||||
663648|NCT01801111|Primary|Recommended Phase II Dose of Alectinib|RP2D was to be determined based on the safety and tolerability profile of the study treatment.|Cycle 1 (up to 28 days)|The endpoint was not analyzed in this study as the RP2D was confirmed in study NP28761 (NCT01871805).|||||
663649|NCT01800968|Secondary|Global Ranking of Predefined Events|A rank score based on time to death, time to adjudicated heart failure hospitalization, time to emergency department visit and time-averaged proportional change in NTproBNP through d180. See Outcome Measure 1 for a general description of the outcome derivation.|Baseline to 180 days|All randomized subjects.||rank||Standard Deviation|Mean
663650|NCT01800968|Secondary|Individual Component of the Primary Endpoint- Time-averaged Proportional Change in NT-proBNP|Individual component of the primary endpoint- time-averaged proportional change in NT-proBNP from baseline to 180 days|Baseline to 180 days|All randomized subjects.||weighted average of ratio to baseline||Standard Deviation|Mean
663651|NCT01800968|Secondary|Individual Component of the Primary Endpoint- Heart Failure Hospitalization|Individual component of the primary endpoint- Heart Failure hospitalization from randomization to 180 days|Randomization to 180 days|All randomized subjects.||participants|||Number
663652|NCT01800968|Secondary|Individual Component of the Primary Endpoint- Mortality|Individual component of the primary endpoint of mortality at 180 days after randomization|Randomization to 180 days|All randomized subjects.||participants|||Number
663653|NCT01800968|Secondary|Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score.|Kansas City Cardiomyopathy Questionnaire (KCCQ) change in overall summary score baseline to 180 days.The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Each question is answered by the subject on a 6 point scale (Extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, Limited for other reasons or did not do this activity).Scores are transformed to a range of 0-100, in which higher scores reflect better health status.|Baseline to 180 days|All randomized subjects.||units on a scale||Standard Deviation|Mean
663654|NCT01800968|Secondary|Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score|Kansas City Cardiomyopathy Questionnaire (KCCQ) change in overall summary score baseline to 90 days.The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Each question is answered by the subject on a 6 point scale (Extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, Limited for other reasons or did not do this activity).Scores are transformed to a range of 0-100, in which higher scores reflect better health status.|Baseline to 90 days|All randomized subjects.||units on a scale||Standard Deviation|Mean
663673|NCT01800318|Secondary|Duration of Crying After TENS Unit Was Initiated But Before Heel Stick.|(a) Any crying after initiation of TENS unit was noted. If the PIPP scores increased by 4 points from baseline, the TENS unit would have been turned off and the infant withdrawn from the study (safety outcome).|10 minutes|||seconds||Standard Deviation|Mean
663674|NCT01800318|Secondary|Change in Heart Rate Variability During Heel Stick|Changes in Heart Rate Variability (HRV) were evaluated using the DL 900 monitor with 3-channel output with 5 leads. Premature infant leads from Braemar, Incorporated, were used with the DL 900 monitor. Leads were applied to the infant's chest before initiation of the TENS unit and the heel stick. The DL300 Holter Monitor will started recording HRV within 10 minutes of TENS unit initiation and the heel stick procedure and continued recording during the procedure and for 2 minutes afterwards.|Baseline, 20 minutes +/- 5 minutes|Newborn infants||LF/HF ratio||Standard Deviation|Mean
663655|NCT01800968|Secondary|Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score|Kansas City Cardiomyopathy Questionnaire (KCCQ) change in overall summary score baseline to 30 days.The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Each question is answered by the subject on a 6 point scale (Extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, Limited for other reasons or did not do this activity).Scores are transformed to a range of 0-100, in which higher scores reflect better health status.|Baseline to 30 days|All randomized subjects.||units on a scale||Standard Deviation|Mean
663656|NCT01800968|Secondary|Change in Clinical Summary Score Using the Kansas City Cardiomyopathy Questionnaire (KCCQ)|Change in clinical summary score using the Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline to day 180.The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Each question is answered by the subject on a 6 point scale (Extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, Limited for other reasons or did not do this activity).Scores are transformed to a range of 0-100, in which higher scores reflect better health status.|Baseline to day 180|All randomized subjects.||units on a scale||Standard Deviation|Mean
663657|NCT01800968|Secondary|Change in Clinical Summary Score Using the Kansas City Cardiomyopathy Questionnaire (KCCQ)|Change in clinical summary score using the Kansas City Cardiomyopathy Questionnaire (KCCQ) baseline to 90 days.The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Each question is answered by the subject on a 6 point scale (Extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, Limited for other reasons or did not do this activity).Scores are transformed to a range of 0-100, in which higher scores reflect better health status.|Baseline to 90 days|All randomized subjects.||units on a scale||Standard Deviation|Mean
663658|NCT01800968|Secondary|Change in Clinical Summary Score Using the Kansas City Cardiomyopathy Questionnaire (KCCQ)|Change in clinical summary score using the Kansas City Cardiomyopathy Questionnaire (KCCQ) baseline to 30 days. The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Each question is answered by the subject on a 6 point scale (Extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, Limited for other reasons or did not do this activity).Scores are transformed to a range of 0-100, in which higher scores reflect better health status.|Baseline to 30 days|All randomized subjects.||units on a scale||Standard Deviation|Mean
663659|NCT01800968|Secondary|Change in 6 Minute Walk Distance|Change in 6 minute walk distance baseline to 180 days.|Baseline to 180 days|All randomized subjects.||meters||Standard Deviation|Mean
663660|NCT01800968|Secondary|Change in 6 Minute Walk Distance|Change in 6 minute walk distance baseline to 90 days.|Baseline to 90 days|All randomized subjects.||meters||Standard Deviation|Mean
663661|NCT01800968|Secondary|Change in 6 Minute Walk Distance|Change in 6 minute walk distance baseline to day 30|Baseline to day 30|All randomized subjects.||meters||Standard Deviation|Mean
663662|NCT01800968|Secondary|Change in Lateral Filling Pressure|Change in lateral filling pressure baseline to day 180.|Baseline to 180 days|All randomized subjects.||m/sec||Standard Deviation|Mean
663663|NCT01800968|Secondary|Change in Medial Filling Pressure|Change in medial filling pressure baseline to day 180.|Baseline to 180 days|All randomized subjects.||m/sec||Standard Deviation|Mean
663664|NCT01800968|Secondary|Change in Left Ventricular Ejection Fraction|Change in left ventricular ejection fraction from baseline to day 180|Baseline to 180 days|All randomized subjects.||percent||Standard Deviation|Mean
663665|NCT01800968|Secondary|Change in Left Ventricular End-systolic Volume Index|Change in left ventricular end-systolic volume index from baseline to day 180.|Baseline to 180 days|All randomized subjects.||ml per meter squared||Standard Deviation|Mean
663666|NCT01800968|Secondary|Change in Left Ventricular End-Diastolic Volume Index|Change in Left Ventricular End-Diastolic Volume Index from baseline to 180 days.|Baseline to 180 days|All randomized subjects.||ml per meter squared||Standard Deviation|Mean
663667|NCT01800968|Primary|Global Ranking of Predefined Events|A rank score based on time to death, time to adjudicated heart failure hospitalization, and time-averaged proportional change in NTproBNP through d180. For patients that died, the patient with the shortest time from randomization to death is assigned rank 1, the second shortest time is assigned rank 2, etc. The patient with the longest time from randomization to death is assigned rank X. For patients that did not die but had a heart failure hospitalization, the patient with the shortest time from randomization to re-admission is assigned rank X+1 and the patient with the longest time from randomization to heart failure hospitalization is assigned rank Y. For patients that did not die or have a heart failure hospitalization, increases in time-averaged proportional change in NTproBNP indicate a worse result and the largest increase is assigned rank Y+1. The patient with the largest decrease is assigned rank N, where N is the sample size.|Randomization to 180 days|All randomized subjects.||rank||Standard Deviation|Mean
664053|NCT01791413|Primary|Percentage Changes of Serum Anti-Mullerian Hormone (AMH) at 2-week and 3-month Post Operation||Within the first 2 weeks and 3 months after surgery|||percentage of serum AMH change||Inter-Quartile Range|Median
663676|NCT01800318|Primary|Changes From Baseline Premature Infant Pain Profile (PIPP) Score to Average PIPP Score During Heel Stick and Squeeze.|"The PIPP score includes assessment of contextual, physiological, and behavioral parameters and has been extensively validated for pain assessment in preterm and term infants. PIPP scores were given at baseline before initiation of the TENS unit,and every 30 seconds for the first two minutes of the heel stick and heel squeeze (4 times). The four PIPP scores given during heel stick and squeeze were averaged.
Behavioral portion of PIPP score: facial expressions are videotaped and analyzed. Physiologic portion of PIPP score: Oxygen saturation levels and heart rates are recorded at baseline and then continuously throughout initiation of the TENS unit and the heel stick procedure. Contextual score - gestational age + sleep/wake state. Subscale scores are added for a total PIPP score. Total or composite PIPP scores are reported.
Scores on the PIPP for full term infants range from 0-18, with 0 being no pain, 1-6 minimal pain, 7-12 moderate pain, 13-18 severe pain."|Baseline and first two minutes of heel stick an squeeze. PIPP scores are given every 30 seconds for the first two minutes of the heel stick and squeeze and then averaged..|Analysis of PIPP scores assigned during heelstick procedure in newborn infants||units on a scale (PIPP score)||Standard Deviation|Mean
663687|NCT01799941|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|AEs (defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product) and SAEs (defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening [ie, the participant was at immediate risk of death from the AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death], required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was as a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug) were assessed during the study.|From signing of informed consent up to 30 days after receiving the last dose of study drug or up to approximately 120 days|The analysis was performed using the safety population that consisted of all enrolled patients who received at least 1 dose of study drug.||Participants|||Number
663688|NCT01799941|Secondary|Percentage of Participants With Treatment Satisfaction Survey|The treatment satisfaction survey was a 5 point single question survey that was administered by the site staff to the participant/participant’s caregiver. Participants were asked to rate their response to treatment satisfaction as: very dissatisfied, somewhat dissatisfied, neither satisfied nor dissatisfied, somewhat satisfied, and very satisfied. Data is presented as percentage of participants with treatment satisfaction at Day 90. Percentages within a measure may not sum to 100.0 due to rounding. Percentages use the count of participants with non-missing data as the denominator.|Day 90 (Final visit)|The mITT Population consisted of all participants who met all inclusion criteria, including a score of at least 13 on the CNS-LS, who received at least 1 dose of study drug, and who had at least 1 post-baseline efficacy measurement with CNS-LS.||Percentage of participants|||Number
663689|NCT01799941|Secondary|Percentage of Participants With Patient Global Impression-Change (PGI-C) Score at Day 90|PGI-C, a participant/participant’s caregiver-assessed scale was used to measure participant overall treatment response. PGI-C, a 7-point (1-7) scale was rated as: very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse. Data is presented as percentage of participants with PGI-C score at Day 90. Percentages within a measure may not sum to 100.0 due to rounding. Percentages use the count of participants with non-missing data as the denominator.|Day 90 (Final visit)|The analysis population consisted of all participants who met all inclusion criteria, including a score of at least 13 on the CNS-LS, who received at least 1 dose of study drug, and who had at least 1 post-baseline efficacy measurement with PGI-C.||Percentage of participants|||Number
663721|NCT01799226|Other Pre-specified|Plaque Samples Will be Collected for Bacterial Species Detection.|Supra- and sub-gingival plaque samples will be gently collected using a sterile curet and a one stroke method from two randomized sites within the stent area. The detection of 40 bacterial species will be evaluated by the checkerboard DNA-DNA hybridization technique originally described by Socransky et al. 1994.|Baseline to 35 Days||||||
663690|NCT01799941|Secondary|Percentage of Participants With Clinical Global Impression-Change (CGI-C) Score at Day 90|CGI-C, an investigator-assessed scale was used to measure the overall treatment response. CGI-C, a 7-point (1-7) scale was rated as: very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse. Data is presented as percentage of participants with CGI-C score at Day 90. Percentages within a measure may not sum to 100.0 due to rounding. Percentages use the count of participants with non-missing data as the denominator.|Day 90 (Final visit)|The analysis population consisted of all participants who met all inclusion criteria, including a score of at least 13 on the CNS-LS, who received at least 1 dose of study drug, and who had at least 1 post-baseline efficacy measurement with CGI-C.||Percentage of participants|||Number
663691|NCT01799941|Secondary|Mean Change From Baseline in Quality of Life Visual Analog Scale (QOL-VAS) Score at Day 90|The QOL-VAS, a participant reported scale of quality of life (QOL) was used to measure the impact of PBA episodes on the participant’s QOL over the previous 7 days (prior to visit) at Baseline (Day 1) and Day 90 (Final visit). The assessment was completed by a participant placing a mark on a horizontal line that extends from 0 “not (affected) at all” to 10 “significantly (affected)”. The participant’s mark was measured and recorded at each time point. The change in QOL-VAS score from baseline to day 90 visit, defined as the day 90 score minus the baseline score, was analyzed. Data is reported as mean QOL-VAS score; a positive change in score represented an increase in participant’s quality of life.|Day 90 (Final visit)|The analysis population consisted of all participants who met all inclusion criteria, including a score of at least 13 on the CNS-LS, who received at least 1 dose of study drug, and who had at least 1 post-baseline efficacy measurement with QOL-VAS.||Units on a scale||Standard Deviation|Mean
663692|NCT01799941|Secondary|Percentage of Participants With ≥ 75% Reduction in PBA Episode Count Per Week|Data is reported as the percentage of participants with ≥ 75% reduction in PBA episode count/week.|Day 30 (Visit 1) and Day 90 (Final visit)|The analysis population consisted of all participants who met all inclusion criteria, including a score of at least 13 on the CNS-LS, who received at least 1 dose of study drug, and who had at least 1 post-baseline efficacy measurement with PBA episode.||Percentage of participants|||Number
663693|NCT01799941|Secondary|Percentage of Participants With ≥ 50% Reduction in PBA Episode Count Per Week|Data is reported as the percentage of participants with ≥ 50% reduction in PBA episode count/week.|Day 30 (Visit 1) and Day 90 (Final visit)|The analysis population consisted of all participants who met all inclusion criteria, including a score of at least 13 on the CNS-LS, who received at least 1 dose of study drug, and who had at least 1 post-baseline efficacy measurement with PBA episode.||Percentage of participants|||Number
663694|NCT01799941|Secondary|Percentage Change From Baseline in PBA Episode Count Per Week|The change from the baseline PBA rate was measured using Mixed Effects Poisson Regression Model (adjusted for gender and age [≤ 65 years]).|Day 30 (Visit 1) and Day 90 (Final visit)|The analysis population consisted of all participants who met all inclusion criteria, including a score of at least 13 on the CNS-LS, who received at least 1 dose of study drug, and who had at least 1 post-baseline efficacy measurement with PBA episode.||percent change||95% Confidence Interval|Mean
663695|NCT01799941|Secondary|Percentage of Participants With PBA Remission|PBA remission was defined as participants with one or more episodes reported at the baseline (Day 1) visit and zero episodes reported at the Day 30 (Visit 1) or Day 90 (Final visit). Data is reported as percentage of participants with no reported episodes over the previous 7 days (prior to visit) at Day 30 (Visit 1) and Day 90 (Final visit).|Day 30 (Visit 1) and Day 90 (Final visit)|The analysis population consisted of all participants who met all inclusion criteria, including a score of at least 13 on the CNS-LS, who received at least 1 dose of study drug, and who had at least 1 post-baseline efficacy measurement with PBA episode.||Percentage of participants|||Number
663696|NCT01799941|Secondary|Mean Pseudobulbar Affect (PBA) Episode Count Per Week by Visit|PBA episode count was an investigator assessed measure in which the participant/participant’s daytime caregiver was asked to identify, count and recall the total episodes of exaggerated/uncontrollable laughing or crying over the previous 7 days (prior to visit) at Baseline (Day 1), Day 30 (Visit 1), and Day 90 (Final visit). The response categories for this question were: 0, 1- 2, 3-5, 6-10, >10. The original responses from participants were converted to estimate the continuous number of PBA episodes by taking the mid-point of the original response ranges and multiplying that value by 7. Data is presented as mean PBA count per week.|Baseline (Day 1), Day 30 (Visit 1), and Day 90 (Final visit)|The analysis population consisted of all participants who met all inclusion criteria, including a score of at least 13 on the CNS-LS, who received at least 1 dose of study drug, and who had at least 1 post-baseline efficacy measurement with PBA episode.||Count/week||Standard Deviation|Mean
663697|NCT01799941|Secondary|Mean Change From Baseline in Center for Neurologic Study-Lability Scale (CNS-LS) Score at Day 30|The CNS-LS was a seven-item, self-administered questionnaire, completed by the participant or participant’s caregiver that provided a quantitative measure of the perceived frequency and severity of Pseudobulbar Affect (PBA) episodes. It consisted of two subscales measuring labile laughter (four items) and labile crying (three items). Each item was rated on a scale from 1 (applies never) to 5 (applies most of the time). The total score was calculated as the sum of the item values that resulted in a score ranging from 7 (no symptoms) to 35 (maximum symptom severity and frequency). A single continuous variable was created for the reported time point. The change in CNS-LS was calculated as the score from the Day 30 assessment minus the Baseline CNS-LS measure. A negative change represented a decrease in CNS-LS score over time following the baseline assessment indicating a perceived decrease in frequency and severity of PBA episodes.|Day 30|The analysis was performed using the mITT population, defined as all participants who met all inclusion criteria, with a score of at least 13 on the CNS-LS, who received at least 1 dose of study drug, and who had at least 1 post-baseline efficacy measurement with CNS-LS.||Units on a scale||Standard Deviation|Mean
663722|NCT01799226|Other Pre-specified|Unstimulated Whole Saliva Will be Collected for Inflammatory Biomarker Expression.|Inflammatory biomarker expression will be quantified using a custom human 10-complex protein array that is optimized for sensitivity, specificity, stability, and intraassay coefficient of variation by comparing to single cytokine enzyme-linked immunosorbent assays (Quantibody Custom Array, RayBiotech, Norcross, GA).|Baseline to 35 Days||||||
663817|NCT01797445|Secondary|Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 96|Urine Beta-2-microglobulin is a renal biomarker which is used to detect drug-induced kidney injury.|Baseline; Week 96|Participants in the Safety Analysis Set with available data were analyzed.||percent change in ratio (µg/g)||Inter-Quartile Range|Median
663698|NCT01799941|Primary|Mean Change From Baseline in Center for Neurologic Study-Lability Scale (CNS-LS) Score at Day 90|The CNS-LS was a seven-item, self-administered questionnaire, completed by the participant or participant’s caregiver that provided a quantitative measure of the perceived frequency and severity of Pseudobulbar Affect (PBA) episodes. It consisted of two subscales measuring labile laughter (four items) and labile crying (three items). Each item was rated on a scale from 1 (applies never) to 5 (applies most of the time). The total score was calculated as the sum of the item values that resulted in a score ranging from 7 (no symptoms) to 35 (maximum symptom severity and frequency). A single continuous variable was created for the reported time point. The change in CNS-LS was calculated as the score from the Day 90 assessment minus the Baseline CNS-LS measure. A negative change represented a decrease in CNS-LS score over time following the baseline assessment indicating a perceived decrease in frequency and severity of PBA episodes.|Day 90 (Final visit)|The analysis was performed using the Modified Intent-to-treat (mITT) Population, defined as all participants who met all inclusion criteria, with a score of at least 13 on the CNS-LS, who received at least 1 dose of study drug, and who had at least 1 post-baseline efficacy measurement with CNS-LS.||Units on a scale||Standard Deviation|Mean
663699|NCT01799720|Secondary|Glutamic Pyruvic Transaminase (GPT) (U/L) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).|In this table the investigators present the Glutamic Pyruvic Transaminase (GPT) of the three intervented groups. Data are mean ± sem.|Days 1 and 30|||Units / litre||Standard Error|Mean
663700|NCT01799720|Secondary|Triglycerides (TGs) (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).|In this table the investigators present the Triglycerides (TGs) of the three intervented groups. Data are mean ± sem.|Days 1 and 30|||milligram / decilitre||Standard Error|Mean
663701|NCT01799720|Secondary|Cholesterol (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).|In this table the investigators present the cholesterol of the three intervented groups. Data are mean ± sem.|Days 1 and 30|||milligram / decilitre||Standard Error|Mean
663702|NCT01799720|Secondary|Glucose (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).|In this table the investigators present the glucose of the three intervented groups. Data are mean ± sem.|Days 1 and 30|||milligram / decilitre||Standard Error|Mean
663703|NCT01799720|Secondary|Diastolic Pressure (mmHg) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).|In this table the investigators present the diastolic pressure of the three intervented groups. Data are mean ± sem.|Days 1 and 30|||millimetres of mercury||Standard Error|Mean
663704|NCT01799720|Secondary|Systolic Pressure (mmHg) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).|In this table the investigators present the systolic pressure of the three intervented groups. Data are mean ± sem.|Days 1 and 30|||millimetres of mercury||Standard Error|Mean
663705|NCT01799720|Secondary|Hip/Waist Ratio of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30)|In this table the investigators present the hip/waist ratio of the three intervented groups. Data are mean ± sem.|Days 1 and 30|||ratio*100||Standard Error|Mean
663706|NCT01799720|Secondary|Body Mass Index (BMI) (Kg/m2) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).|In this table the investigators present the Body Mass Index of the three intervented groups. Data are mean ± sem.|Days 1 and 30|||kilogram / square metre||Standard Error|Mean
663707|NCT01799720|Secondary|Height (Metre) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).|In this table the investigators present the height of the three intervented groups. Data are mean ± sem.|Days 1 and 30|||metres||Standard Error|Mean
663708|NCT01799720|Primary|Weight (Kilogram) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30)|In this table the investigators present the weight (kilogram) of the three intervented groups. Data are mean ± sem.|Days 1 and 30|||kilogram||Standard Error|Mean
663709|NCT01799590|Secondary|Quality of Life (QOL) Questionnaire (Short Form-36 [SF-36]) Score|The SF-36 is a standardized survey evaluating 8 domains (consisting of 2 components; physical and mental) of functional health and well being: physical and social functioning, physical and emotional role (role-physical, role-emotional) limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Final evaluation (FE) was done at Day 225 or at discontinuation.|Baseline (28 days before randomization) and FE (Day 225/early discontinuation)|The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization. Here ‘n’ signifies those participants who were evaluable for this measure at given time points.||Units on a scale||Standard Deviation|Mean
663710|NCT01799590|Secondary|Percentage of Participants With Response to Treatment|Responders were defined as participants who had a 50 percent or more reduction in frequency of migraine attacks. Migraine is common disabling headache disorder with 2 subtypes: migraine without aura (at least 5 attacks lasting 4-72 hours with at least 2 characteristics: unilateral location, pulsating quality, moderate/severe pain or aggravation by/causing avoidance of routine physical activity and either nausea/vomiting or photophobia and phonophobia) and migraine with aura (attack with reversible focal neurological symptoms that develop over 5-20 minutes and last for less than 60 minutes).|Baseline (28 days before randomization) up to Day 225|The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization.||Percentage of participants|||Number
663711|NCT01799590|Secondary|Change From Baseline in the Average Number of Monthly Rescue-Drug Treatment Days in Continuous Treatment Period|If aura of migraine, migraine attack or non-migraine headache attack occurred in study, these rescue drugs were permitted:analgesics, non-steroidal anti-inflammatory drugs (NSAIDs),ergotamines,triptans,antiemetics. Drugs with restricted treatment days of less than (<) 15 days per month (28 days):analgesics, NSAIDs,combination of rescue drugs and those with <10 days per month:triptans,ergotamines, opioids,combination analgesics. Average calculated as total number of monthly rescue-drug treatment days divided by the total number of days of assessment and multiplied by 28, where a month = 28 days.|Baseline (28 days before randomization) and Continuous treatment period (Day 1 up to Day 225)|The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization.||Days||Standard Deviation|Mean
663712|NCT01799590|Secondary|Change From Baseline in the Number of Migraine Attacks as Per 24-hour Rule Over Day 197 to Day 225 in Continuous Treatment Period|As per 24-hour rule, if symptom of pain because of migraine continues for more than 24 hours, it should be considered as 2 or more migraine attacks considering the maximum duration up to 24 hours. If interval between the latest migraine attack (ending time) and previous migraine attack (onset time) is less than 24 hours, 2 migraine attacks were considered as 1 migraine attack. If the onset of the migraine was prevented by a rescue drug it was considered as 1 migraine attack even if the aura had started.|Baseline (28 days before randomization) and Day 197 to Day 225|The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization.||Migraine attacks||Standard Deviation|Mean
663713|NCT01799590|Secondary|Change From Baseline in the Number of Monthly Migraine Attacks as Per 48-hour Rule in Continuous Treatment Period|As per 48-hour rule, if the symptom of pain because of migraine continues for more than 48 hours, it should be considered as 2 or more migraine attacks considering the maximum duration up to 48 hours. If the interval between the latest migraine attack (ending time) and the previous migraine attack (onset time) is less than 48 hours, 2 migraine attacks were considered as 1 migraine attack. If the onset of the migraine was prevented by a rescue drug it was considered as 1 migraine attack even if the aura had started.|Baseline (28 days before randomization) and Continuous treatment period (Day 1 up to Day 225)|The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization.||Migraine attacks||Standard Deviation|Mean
663714|NCT01799590|Secondary|Change From Baseline in the Average Number of Migraine Attacks According to the Diagnostic Criteria of the International Headache Society Per Month in Continuous Treatment Period|Migraine has 2 major subtypes: migraine without aura (minimum 5 attacks of headache lasting for 4-72 hours, has 2 of these characteristics [unilateral location, pulsating quality, moderate or severe pain intensity, aggravation by or causing avoidance of routine physical activity] and either nausea/vomiting or photophobia and phonophobia) and migraine with aura (2 attacks of headache with typical aura with migraine headache or typical aura with non-migraine headache or typical aura without headache or familial hemiplegic migraine or sporadic hemiplegic migraine or basilar-type migraine).|Baseline (28 days before randomization) and Continuous treatment period (Day 1 up to Day 225)|The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization.||Migraine attacks||Standard Deviation|Mean
663715|NCT01799590|Secondary|Change From Baseline in the Average Number of Monthly Headache Days in Continuous Treatment Period|Migraine headache day was defined as a calendar day with any occurrence of migraine headache pain of at least 30 minutes in duration. Average was calculated as total number of monthly headache days divided by total number of days of assessment and multiplied by 28, where a month was considered to last 28 days.|Baseline (28 days before randomization) and Continuous treatment period (Day 1 up to Day 225)|The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization.||Days||Standard Deviation|Mean
663716|NCT01799590|Secondary|Change From Baseline in the Average Number of Monthly Migraine Attack Days in Continuous Treatment Period|Migraine:disabling headache disorder;2 major subtypes:migraine without aura(at least 5 attacks for 4-72 hours with at least 2 characteristics: unilateral location,pulsating quality,moderate/severe pain intensity or aggravation by/causing avoidance of routine physical activity and either nausea/vomiting or photophobia,phonophobia);migraine with aura(attack with reversible focal neurological symptoms that develop over 5-20 minutes, last for less than 60 minutes);average=total number of migraine attack days divided by total number of days of assessment and multiplied by 28,where a month=28 days.|Baseline (28 days before randomization) and Continuous treatment period (Day 1 up to Day 225)|The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization.||Days||Standard Deviation|Mean
663717|NCT01799590|Secondary|Change From Baseline in the Number of Monthly Migraine Attacks as Per 24-hour Rule in the Continuous Treatment Period|As per 24-hour rule, if symptom of pain because of migraine continues for more than 24 hours, it should be considered as 2 or more migraine attacks considering the maximum duration up to 24 hours. If interval between the latest migraine attack (ending time) and previous migraine attack (onset time) was less than 24 hours, 2 migraine attacks were considered as 1 migraine attack. If the onset of the migraine was prevented by a rescue drug it was considered as 1 migraine attack even if the aura had started.|Baseline (28 days before randomization) and Continuous treatment period (Day 1 up to Day 225)|Full analysis set (FAS) included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization.||Migraine attacks||Standard Deviation|Mean
663718|NCT01799590|Primary|Number of Participants With Adverse Events|An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.|Baseline up to 28 days after last dose of study drug|Safety population included all participants who received at least 1 dose of study medication.||Participants|||Number
663719|NCT01799239|Primary|Leakage (Percentage of All Baseplates With Leakage)|"leakage is measured using a 4-point leakage scale developed by Coloplast A/S. At every baseplate change the subjects had to look at the skin facing side of the baseplate and access which of the four scenarios described below provided an accurate description of the baseplate.
The subjects tick of one of the four possible answers:
No leakage
Starting to leak (leakage under the baseplate)
Leakage (seepage of faeces resulting in leakage on clothes)
Sudden leakage (the baseplate pops off resulting in sudden leakage under the baseplate and outside the baseplate)"|After each baseplate change over a period, of 7 days|||percentage baseplates with leakage|Participants||Number
663720|NCT01799226|Other Pre-specified|Gingival Crevicular Fluid (GCF) Will be Collected for Inflammatory Biomarker Expression.|A total of 10 biomarkers will be analyzed based on the results from Lee and colleagues: IL-1α, IL-1β, IL-6, IL-8, IL-10, MCP-1, MMP-8, MMP-9, TIMP-1, and TIMP-2.|Baseline to 35 Days||||||
663723|NCT01799226|Primary|Change From Baseline in Plaque Index (Silness & Loe 1964) to Day 35|Silness & Loe 1964 is a score of 0-3 with 0 = No plaque, 1 = A film of plaque adhering to free gingival margin and adjacent area of tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface, 2 = Moderate accumulation of soft deposits within the gingival pocket, or on the tooth and gingival margin, which can be seen with the naked eye, 3 = Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin. This index was used at days 0, 14, 21 and 35.|Baseline to 35 Days|Data analysis only included examining the test (triclosan dentifrice) or control (fluoride dentifrice).||units on a scale||Standard Error|Mean
663724|NCT01799226|Secondary|Change From Baseline in Gingival Index (Loe & Silness 1963) to Day 35|Loe & Silness 1963 is a score of 0-3 with 0 = Absence of inflammation, 1 = Mild inflammation, slight change in color and texture, 2 = Moderate inflammation, glazing, redness, edema and hypertrophy, 3 = Severe inflammation, redness and hypertrophy, ulceration. This index was used at days 0, 14, 21 and 35.|Baseline to 35 Days|Data analysis only included examining the test (triclosan dentifrice) or control (fluoride dentifrice).||units on a scale||Standard Error|Mean
663725|NCT01798992|Other Pre-specified|Change in Myocardial microRNA Expression at 12 Months|Changes in myocardial microRNA expression at 12 months compared to baseline using an Affymetrix microRNA microarray assay. Data are not presented for non-failing controls, who only went baseline evaluation and did not undergo treatment, given that they did not have heart failure.|12 months||||||
663726|NCT01798992|Other Pre-specified|Change in Myocardial microRNA Expression at 3 Months|Changes in myocardial microRNA expression at 3 months compared to baseline using an Affymetrix microRNA microarray assay. Data are not presented for non-failing controls, who only went baseline evaluation and did not undergo treatment, given that they did not have heart failure.|3 months||||||
663727|NCT01798992|Other Pre-specified|Change in Myocardial Gene Expression at 12 Months|Changes in myocardial mRNA expression at 12 months compared to baseline using targeted quantitative polymerase chain reaction and Affymetrix genome-wide microarray assays. Data are not presented for non-failing controls, who only went baseline evaluation and did not undergo treatment, given that they did not have heart failure.|12 months||||||
663728|NCT01798992|Other Pre-specified|Change in Myocardial Gene Expression at 3 Months|Changes in myocardial mRNA expression at 3 months compared to baseline using targeted quantitative polymerase chain reaction and genome wide microarray assays. Due to the large number of results genes interrogated (~ 20,000 genes), these results will instead be uploaded to the Gene Expression Omnibus.|3 months||||||
663729|NCT01798992|Secondary|Composite of All-cause Mortality, Need for Heart Transplant or Need for Ventricular Assist Device.|Clinical status at 18 months will be assessed at time of study completion, specifically for the composite outcome of all-cause mortality, need for heart transplant, or need for ventricular assist device. Outcomes are not presented for non-failing controls, who only went baseline evaluation and did not undergo treatment, given that they did not have heart failure.|18 months|Idiopathic dilated cardiomyopathy patients randomized to different beta-blocker strategies. Data does not include non-failing controls, as these patients only underwent baseline evaluation with no treatment or follow-up, given that they did not have heart failure.||participants|||Number
663730|NCT01798992|Secondary|Improvement in LVEF at 3 Months|A secondary outcome will be LVEF response at 3 months, defined as an improvement of ≥ 5% Data are not presented for non-failing controls, who only went baseline evaluation and did not undergo treatment, given that they did not have heart failure.|3 months|||LVEF responders|||Number
663731|NCT01798992|Primary|Improvement in Left Ventricular Ejection Fraction (LVEF) at 12 Months|The primary clinical outcome will be LVEF response at 12 months defined as an improvement in LVEF of ≥ 8% at 12 months or if not available, ≥5% at 3 months in the absence of an adverse clinical outcome. Data are not presented for non-failing controls, who only went baseline evaluation and did not undergo treatment, given that they did not have heart failure.|12 months|Idiopathic dilated cardiomyopathy patients naive to beta-blocker therapy||LVEF responders|||Number
663732|NCT01798966|Other Pre-specified|Adverse Events and Serious Adverse Events|Safety will be evaluated throughout the duration of the study by collecting all adverse events|4 days|||Number of AE|||Number
663733|NCT01798966|Secondary|IOP Patterns|The pattern of IOP in patients with TED will be compared with the pattern of IOP readings in normal subjects as well as glaucomatous patients|24 hours|||mvEq||Standard Deviation|Mean
663734|NCT01798966|Primary|Change in IOP Before and After Orbital Decompression Surgery|To investigate the difference in SENSIMED Triggerfish output during transition from wake to sleep states before and after orbital decompression|24 hours|||mVEq (Sensismed Triggerfish output unit)||Standard Deviation|Median
663735|NCT01798927|Other Pre-specified|Change in Walking Endurance by Use of 6-Minute Walk Test From Initial to Final Testing|Each participant will be asked to walk at a self-selected velocity on level surfaces for 6 minutes. They will be allowed to use assistive devices if necessary.|Done at time of enrollment in the study, i.e. baseline and week 10 post enrollment|data from 3 of the 4 participants was analyzed||meters||Standard Deviation|Mean
663736|NCT01798927|Secondary|Number of Participants With a Change in Electromyography of Key Lower Extremity Muscles From Initial to Final Testing|Surface electromyography will be done on key muscles in the lower extremity (quads, anterior tibialis, gastrocnemius) during computerized gait assessment. Changes in EMG activity include things such as increases in amplitude or timing that might indicate increases in strength or motor learning as a result of wearing the ankle foot orthosis.|Done at time of enrollment in the study, i.e. baseline and week 10 post enrollment.|EMG data was analyzed from 3 of the 4 participants||participants|||Number
663737|NCT01798927|Primary|Change in Step Length by Means of Computerized Gait Analysis From Initial to Final Testing|Participants will be asked to walk on a 12-16 foot long vinyl pad placed on the floor. The mat will record and analyze step length.|Done at time of enrollment in the study, i.e. baseline and 10 weeks post enrollment|step length was analyzed from the GAITRite||cm||Standard Deviation|Mean
663738|NCT01798706|Secondary|Percentage of Participants With Gastrointestinal Disorders||Up to Day 171|Analysis was performed on safety population.||percentage of participants|||Number
663800|NCT01797783|Secondary|Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses|Visual Acuity was tested while reading charts at a distance of 40 cm from the participant with both eyes together. The Snellen fraction 20/20 represents 'normal' near vision. A larger denominator indicates a lower visual acuity.|Up to Day 30|This reporting group includes all randomized and dispensed participants who completed the study.||participants|||Number
663739|NCT01798706|Secondary|Percentage of Participants With HbA1c Reduction >0.5% at Week 24 and Did Not Experienced Documented (Plasma Glucose <60 mg/dL) Symptomatic Hypoglycemia|The on-treatment period for HbA1c assessment was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. The on-treatment period for symptomatic hypoglycemia assessment was defined as the time from the first dose of study drug up to 1 day after the last dose of study drug.|Week 24|mITT population. Participants without any post-baseline on-treatment value for HbA1c were counted as non-responders if they experienced at least one symptomatic hypoglycemia. Otherwise, they were counted as missing.||percentage of participants|||Number
663740|NCT01798706|Secondary|Percentage of Participants With Symptomatic and Severe Symptomatic Hypoglycemia|Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the participant required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.|First dose of study drug up to 3 days after the last dose administration (maximum of 171 days)|Analysis was performed on safety population defined as all randomized participants who received any amount of study drug.||percentage of participants|||Number
663741|NCT01798706|Secondary|Change in Total Daily Basal Insulin Dose From Baseline to Week 24 (in Participants Who Took Basal Insulin as Background Therapy)|Change in basal insulin dose was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug.|Baseline, Week 24|mITT population. Here, number of participants analyzed=participants with baseline and at least one post-baseline basal insulin dose assessment during on-treatment period.||units||Standard Error|Least Squares Mean
663742|NCT01798706|Secondary|Change in Plasma Glucose Excursions From Baseline to Week 24|Plasma glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the liquid standardized breakfast meal test, before study drug administration. Change in plasma glucose excursions were calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug.|Baseline, Week 24|mITT population. Here, number of participants=participants with baseline and at least one post-baseline plasma glucose excursion assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
663743|NCT01798706|Secondary|Percentage of Participants Requiring Rescue Therapy During 24 Week Treatment Period|Routine fasting SMPG and central laboratory FPG (and HbA1c after Week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after Week 12) were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG >270 mg/dL (15.0 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 24: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >9%.|Baseline up to Week 24|mITT population.||percentage of participants|||Number
663744|NCT01798706|Secondary|Change in FPG From Baseline to Week 24|Change in FPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to 1 day after the last dose of study drug.|Baseline, Week 24|mITT population. Here, number of participants analyzed=participants with baseline and at least one post-baseline FPG assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
663745|NCT01798706|Secondary|Change in Body Weight From Baseline to Week 24|Change in body weight was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug.|Baseline, Week 24|mITT population. Here, number of participants analyzed=participants with baseline and at least one post-baseline body weight assessment during on-treatment period.||kg||Standard Error|Least Squares Mean
663746|NCT01798706|Secondary|Change in Average 7-point SMPG Profiles From Baseline to Week 24|Participants recorded a 7-point plasma glucose profile measured before and 2 hours after each meal and at bedtime three times in a week before baseline, before visit Week 12 and before visit week 26 and the average value across the profiles performed in the week a visit for the 7-time points was calculated. Change in average 7-point SMPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to the day of last dose of study drug.|Baseline, Week 24|mITT population. Here, number of participants analyzed=participants with baseline and at least one post-baseline 7-point SMPG assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
663747|NCT01798706|Secondary|Change in 2-Hour PPG From Baseline to Week 24|The 2-hour PPG test measured blood glucose 2 hours after eating a liquid standardized breakfast meal. Change in PPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug.|Baseline, Week 24|mITT population. Here, number of participants analyzed=participants with baseline and at least one post-baseline 2-hour PPG assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
663748|NCT01798706|Primary|Absolute Change in HbA1c From Baseline to Week 24|Change in HbA1c was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using last on-treatment observation carried forward (LOCF). On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. Here, number of participants analyzed=participants with baseline and at least one post-baseline HbA1c assessment during on-treatment period.|Baseline, Week 24|Modified intent to treat (mITT) population: all randomized participants who received at least one dose of study drug; and had both baseline and at least one post-baseline efficacy assessment, irrespective of compliance with study protocol/procedures.||percentage of hemoglobin||Standard Error|Least Squares Mean
663850|NCT01797029|Other Pre-specified|Percentage of Participants With Moderate to Severe, Laboratory-confirmed Influenza Virus Infection Among Children||Through 7 to 9 months post-vaccination||||||
663749|NCT01798485|Secondary|Patient-Reported Symptom Improvement as Measured by the Functional Assessment of Cancer Therapy - Lung (FACT-L) Version 4 Test|"The FACT-L contains 4 general subscales and a Lung Cancer Subscale (LCS). General subscales include: Physical Well-Being (PWB), Social/ Family Well-Being (SWB), Emotional Well-Being (EWB), and Functional Well-Being (FWB). The LCS assesses symptoms commonly reported by lung cancer patients (e.g., shortness of breath, weight loss, and tightness in the chest). The FACT-L total score ranges from 0 to 136, higher scores represent better QOL.
Data were not summarized due to the early termination of the study due to futility."|Day 1 (pre-treatment), Day 63 (Cycle 3 Day 1), Day 105 (Cycle 5 Day 1) and end of trial|Randomized participants|||||
663750|NCT01798485|Secondary|Patient-Reported Quality of Life as Measured by the European Quality Of Life - Five Dimensions - Three Levels (EQ-5D-3L) Survey|"The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. An overall EQ-5D-3L index was calculated (see EuroQoL website, http://www.euroqol.org/eq-5d-products/eq-5d-3l.html), with an index of 1.0 representing full health and and “0” represents dead, with some health states being worse than dead (<”0”).
This study stopped prematurely due to futility and development of this product ceased. The sponsor made a decision at that time to not analyze this outcome. The sponsor no longer has staff or capabilities for further analysis."|Day 1 (pre-treatment), Day 63 (Cycle 3 Day 1), Day 105 (Cycle 5 Day 1) and end of trial|Randomized participants. However, this study stopped prematurely due to futility and development of this product ceased. The sponsor made a decision at that time to not analyze this outcome. The sponsor no longer has staff or capabilities for further analysis.|||||
663751|NCT01798485|Secondary|Participants With Treatment-Emergent Adverse Events as of 23 December 2015|"Treatment-emergent adverse events (AEs) were defined as AEs that occurred from the time of first dose through 30 days after the last dose of study medication. The Investigator graded the severity of AEs according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) criteria:
Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death A Serious AE (SAE) is defined as any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or constitutes an important medical event."|up to 36 months|Safety population||participants|||Number
663752|NCT01798485|Other Pre-specified|Exploratory Biomarker Analyses|Exploratory biomarker analyses was to assess correlation between biomarkers and clinical outcome. However, this study stopped prematurely due to futility and development of this product ceased. The sponsor made a decision at that time to not analyze this outcome. The sponsor no longer has staff or capabilities for further analysis.|up to 36 months|Randomized|||||
663753|NCT01798485|Secondary|Percentage of Participants With Progressive Disease Due to Any New Metastatic Lesion as of 19 October 2015|Progressive disease was due to either new metastatic lesions only or new metastatic lesions and target tumor growth.|up to 36 months|Randomized participants||percentage of participants|||Number
663754|NCT01798485|Secondary|Kaplan-Meier Estimate for Time to Emergence of New Metastatic Lesion (TNL) as of 19 October 2015|TNL was defined as time from the randomization date to the first day of radiological progression that included new metastatic lesions. Participants with no new metastatic lesions were censored at the date of the most recent radiological assessment.|up to 36 months|Randomized participants||months||95% Confidence Interval|Median
663755|NCT01798485|Secondary|Disease Control Rate (DCR) in Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015|"Percentage of participants whose best overall response, as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), was a complete response (CR), a partial response (PR), or stable disease (SD).
CR was defined as the disappearance (or normalization) of all target lesions.
PR was defined as <=30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters.
SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum of diameters while on study. The duration of SD must be for at least 6 weeks or 12 weeks.
Elevated LDH includes values above the upper limit of normal.
This study stopped prematurely due to futility and development of this product ceased. The sponsor made a decision at that time to not analyze this outcome. The sponsor no longer has staff or capabilities for further analysis."|up to 36 months|Randomized participants who had an elevated screening LDH. However, this study stopped prematurely due to futility and development of this product ceased. The sponsor made a decision at that time to not analyze this outcome. The sponsor no longer has staff or capabilities for further analysis.|||||
663756|NCT01798485|Secondary|Objective Response Rate (ORR) in Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015|"Percentage of participants whose best overall response, as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), was either a complete response (CR) or a partial response (PR).
CR was defined as the disappearance (or normalization) of all target lesions.
PR was defined as at least 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters.
Elevated LDH includes values above the upper limit of normal.
This study stopped prematurely due to futility and development of this product ceased. The sponsor made a decision at that time to not analyze this outcome. The sponsor no longer has staff or capabilities for further analysis."|up to 36 months|Randomized participants who had an elevated screening LDH. However, this study stopped prematurely due to futility and development of this product ceased. The sponsor made a decision at that time to not analyze this outcome. The sponsor no longer has staff or capabilities for further analysis.|||||
663757|NCT01798485|Secondary|Progression Free Survival (PFS) in Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015|"The progression-free interval is the interval from the date of randomization until tumor progression per modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1), clinical progression, or death from any cause in the absence of progressive disease, whichever occurs first. Data represents the investigator's assessment.
Progressive Disease (PD) was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Elevated LDH includes values above the upper limit of normal."|up to 36 months|Randomized participants who had an elevated screening LDH||months||95% Confidence Interval|Median
663758|NCT01798485|Secondary|Kaplan-Meier Estimate of Duration of Response (DOR) as of 19 October 2015|"Only participants who achieved a confirmed response (complete response (CR) or partial response (PR)) were included in the DOR analysis.
CR was defined as the disappearance (or normalization) of all target lesions.
PR was defined as at least 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters."|up to 36 months|Randomized participants who had a confirmed response||months||95% Confidence Interval|Median
663759|NCT01798485|Secondary|Disease Control Rate (DCR) as of 19 October 2015|"Percentage of participants whose best overall response, as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), was either a complete response (CR), a partial response (PR), or stable disease (SD).
CR was defined as the disappearance (or normalization) of all target lesions. PR was defined as at least 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters.
SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum of diameters while on study. For participants with a best response of SD, duration of SD must be for at least 6 weeks or 12 weeks."|up to 36 months|Randomized participants||percentage of participants||95% Confidence Interval|Number
663760|NCT01798485|Secondary|Objective Response Rate (ORR) as of 19 October 2015|"Percentage of participants whose best overall response, as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), was either a complete response (CR) or a partial response (PR).
CR was defined as the disappearance (or normalization) of all target lesions. PR was defined as at least 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters."|up to 36 months|Randomized participants||percentage of participants||95% Confidence Interval|Number
663761|NCT01798485|Secondary|Overall Survival (OS) In Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015|OS was measured from the date of randomization to the date of death from any cause. Elevated LDH includes values above the upper limit of normal.|up to 36 months|Randomized participants with elevated LDH at screening||months||95% Confidence Interval|Median
663762|NCT01798485|Secondary|Progression-free Survival (PFS) as of 19 October 2015|"The progression–free interval is the interval from the date of randomization until tumor progression per modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1), clinical progression, or death from any cause in the absence of progressive disease, whichever occurs first. Data represents the investigator's assessment.
Progressive Disease (PD) was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm."|up to 36 months|Randomized participants||months||95% Confidence Interval|Median
663763|NCT01798485|Primary|Overall Survival as of 19 October 2015|Overall survival (OS) was measured from the date of randomization to the date of death from any cause.|up to 36 months|Randomized participants||months||95% Confidence Interval|Median
663764|NCT01798394|Secondary|Protocol Compliance - EDC's Completed|Compliance was measured as the number by number of EDCs completed (maximum of 84).|Gestational Week 36 - Postpartum Week 12|||EDC's completed||Standard Deviation|Mean
663765|NCT01798394|Secondary|Protocol Compliance - Doses of Medication Taken|Compliance was measured by doses of medication taken (maximum of 56).|Postpartum Week 0 - Week 12|||Doses of medication taken||Standard Deviation|Mean
663766|NCT01798394|Secondary|Compliance Determinants|This was determined by the Feasibility Questionnaire; a 10-item measure used to assess participant expectations, satisfaction of study protocol, study medication and electronic data capture. All questions were answered on a four-point Likert-type scale (1=low acceptability and 4=high acceptability). The total score was determined by adding up all the scores and dividing by 10.|Postpartum Week 12|||units on a scale||Standard Deviation|Mean
663767|NCT01798394|Secondary|Protocol Compliance - Number of Visits Attended|Compliance was measured as the number of visits attended (maximum of 5).|Gestational Week 36 - Postpartum Week 12|||Number of visits attended||Standard Deviation|Mean
663768|NCT01798394|Secondary|Number of Participants Who Relapsed at All During Postpartum (up to Day 84)|Defined by continuous abstinence (CA) defined as a single puff of a cigarette as a relapse.|Postpartum Day 0 to 84|||participants|||Number
663769|NCT01798394|Secondary|Number of Participants Who Relapsed by Week 12 Postpartum|Determined by seven-day point prevalence, a binary smoking relapse outcome - defined as a single puff of a cigarette during the seven days prior to a pre-specified time point of interest.|Week 12 Postpartum|||participants|||Number
663770|NCT01798394|Primary|Number of Participants Who Relapsed by Week 4 Postpartum|Determined by seven-day point prevalence, a binary smoking relapse outcome - defined as a single puff of a cigarette during the seven days prior to a pre-specified time point of interest.|Week 4 Postpartum|||participants|||Number
663771|NCT01798316|Other Pre-specified|Narcotic Use During PACU Stay|Narcotic medication administered during PACU stay in morphine milligram equivalents|4 hours plus/minus 30 minutes|||Morphine milligram equivalents||95% Confidence Interval|Mean
663772|NCT01798316|Other Pre-specified|Number of Patients Requiring Rescue Analgesia for Breakthrough Pain|Number of patients requiring rescue analgesia medication during first hour of PACU stay|1 hour following surgery|||Participants|||Count of Participants
663773|NCT01798316|Secondary|Pain Intensity Score 1 Hour Following Surgery Using Numeric Rating Scale|Pain intensity score reported by participants 1 hour following surgery using an 11-point, 0-10 Numeric Rating Scale (NRS). Higher scores indicate higher pain intensities|1 hour following surgery|||Units on a numerical rating scale||Inter-Quartile Range|Median
663774|NCT01798316|Secondary|Patient Satisfaction on a 5 Point Likert Scale|Number of patients very satisfied or satisfied with pain and PONV management during hospital stay|Up to one week following surgery|Post-discharge follow up group. Patients not included in analysis were lost to follow up.||Participants|||Count of Participants
663775|NCT01798316|Secondary|Highest Pain Intensity Score Using Numeric Rating Scale (NRS)|Highest pain intensity reported during PACU stay using a 11-point (0-10) pain intensity numeric rating scale (NRS). Higher values represent higher pain intensities.|4 hours plus/minus 30 minutes|||Units on a numerical rating scale||Inter-Quartile Range|Median
663776|NCT01798316|Secondary|Number of Participants With Post Discharge Nausea and Vomiting (PDNV)|"Number of participants reporting post discharge nausea and vomiting (PDNV) documented up to 2 days following surgery.
PDNV is defined as nausea intensity of 4 or higher on 0-10 numeric rating scale (NRS) and/or at least one episode of vomiting/retching following discharge."|Up to two days following surgery|Post-discharge follow up group. Patients not included in analysis were lost to follow up.||Participants|||Count of Participants
663777|NCT01798316|Primary|Number of Participants With Postoperative Nausea and Vomiting (PONV).|"Number of participants with postoperative nausea and vomiting (PONV) will be recorded during PACU stay.
PONV is defined as nausea intensity of 4 or higher on 0-10 numeric rating scale (NRS) and/or at least one episode of vomiting/retching."|4 hours plus/minus 30 minutes|||Participants|||Count of Participants
663778|NCT01798264|Secondary|Change in Weight From Baseline to 4 Weeks||4 weeks|||kg||Standard Deviation|Mean
663779|NCT01798264|Secondary|Change in Fasting Plasma Glucose (FPG) 4 Weeks From Baseline||4 weeks|||mg/dL||Standard Deviation|Mean
663780|NCT01798264|Secondary|To Characterize the Pharmacokinetic Profile of ITCA 650 in Subjects With Type 2 Diabetes Mellitus|Change in HbA1c from baseline|4 weeks|||percentage||Standard Deviation|Mean
663781|NCT01798264|Primary|Number of Subjects With Study Drug-Related Adverse Events||4 weeks|Number of subjects reporting study drug-related adverse events||participants|||Number
663782|NCT01798186|Secondary|Subjective VAS Drug Effect|"Visual analog scale (0-100; not at all to extremely) of subjective Drug Effect"|immediately post cannabis exposure.|||mm||Standard Deviation|Mean
663783|NCT01798186|Secondary|Delta-9-tetrahydrocannabinol (THC) Cmax in Oral Fluid|After exposure to cannabis, we will conduct a pharmacokinetic analysis of THC in oral fluid.|Samples collected 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 22, 26, 30, and 34 hours post cannabis exposure|||ng/mL||Full Range|Mean
663784|NCT01798186|Primary|Delta-9-tetrahydrocannabinol (THC) Cmax in Blood|After exposure to cannabis, we will conduct a pharmacokinetic analysis of THC in blood collected.|0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 22, 26, 30, and 34 hours post cannabis exposure|||ng/mL||Standard Deviation|Mean
663785|NCT01798134|Secondary|12 Month Survival||12 months|||participants|||Number
663786|NCT01798134|Primary|Freedom From Tumor Progression at 6 Months|Progression was assessed by the modified Response Evaluation Criteria in Solid Tumors (mRECIST - Lencioni and Llovet 2010) as an increase of at least 20% in the sum of the diameters of viable (enhancing) target lesions, taking as reference the smallest sum of the diameters of viable (enhancing) target lesions recorded since treatment started. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm.|6 months|For efficacy outcomes, there were 21 participants with imaging to assess tumor response. No imaging was available for the other participants.||participants|||Number
663787|NCT01798134|Primary|Freedom From Study Related SAE at 6 Months||Up to 6 months|One participant is not included in the analysis as the investigator withdrew the participant 2 days after treatment started and then treated the participant systemically with sorafenib.||participants|||Number
663788|NCT01798134|Primary|Freedom From Serious Adverse Event (SAE) at 30days||Up to 30 days|One participant is not included in the analysis as the investigator withdrew the participant 2 days after treatment started and then treated the participant systemically with sorafenib.||participants|||Number
663789|NCT01798004|Other Pre-specified|Melphalan Pharmacokinetics and the Combination of Busulfan and Melphalan AUC (Optional)|A descriptive analysis of the relationship between melphalan pharmacokinetics and the combination of busulfan and melphalan AUC with the occurrence of non-hematologic toxicities within 28 days following completion of consolidation will be assessed. In addition, the association between melphalan exposure levels as measured by the AUC and event-free survival and overall survival will be examined using Cox proportional hazards models.|Within 28 days post-consolidation||||||
663790|NCT01798004|Other Pre-specified|Proportion of High-risk Neuroblastoma Patients With MYCN Non-amplified Tumors for Whom Molecular Profiling Results Can be Obtained||Within 8 weeks of diagnosis||||||
663791|NCT01798004|Other Pre-specified|Proportion of High-risk Neuroblastoma Patients for Whom ALK Status Can be Obtained||Within 6 weeks of diagnosis||||||
663792|NCT01798004|Other Pre-specified|Percentage of MIBG Scans Receiving Institutionally and Centrally Reviewed and Automated Advanced Assisted Scoring Platform Curie Scores Within 1 Unit of Each Other|Cohen's kappa will be calculated to evaluate the concordance in Curie scores between each of the scoring methods at each time point. Up to 160 MIBG scans are expected at diagnosis and up to 144 MIBG scans from the 90% of patients estimated to be MIBG avid are projected post-course 4 of induction therapy, for a total of up to 304 MIBG scans.|Up to week 12 (course 4 of induction therapy)||||||
663793|NCT01798004|Other Pre-specified|Percentage of Centrally Reviewed Post-course 4 MIBG Scans Reporting a Curie Score Considered to Have Been Determined in “Real Time”||Up to week 12 (course 4 of induction therapy)||||||
663794|NCT01798004|Other Pre-specified|First Dose Area Under the Curve (AUC) and Average Daily AUC for Busulfan|Relationship with occurrence of non-hematologic toxicities assessed by a descriptive analysis. Association between busulfan exposure levels as measured by the area under the curve (AUC) and event-free survival and overall survival will be examined using Cox proportional hazards models.|Within 28 days following consolidation||||||
663795|NCT01798004|Other Pre-specified|Overall Survival||Up to 5 years||||||
663796|NCT01798004|Other Pre-specified|EFS||Up to 5 years||||||
663797|NCT01798004|Other Pre-specified|Response Rate Determined Using the International Response Criteria||Up to 5 years||||||
663798|NCT01798004|Other Pre-specified|Incidence of Non-hematologic Organ Toxicity (Grade 3 and Higher) and All Cause Mortality Graded According to CTC v4.0|Assessed by a descriptive analysis of the incidence of grade 3-5 non-hematologic toxicities (CTC v4.0) and all-cause mortality during consolidation therapy. In addition, a descriptive analysis of “late” onset grade 4-5 pulmonary and hepatic complications that occur within 180 days of the start of consolidation therapy will be examined, regardless if the patient has proceeded to other therapy (including chimeric antibody) during that 180 day period.|Up to 180 days||||||
663799|NCT01798004|Primary|The Tolerability of BuMel Regimen|Number of patients who experience one or more unacceptable toxicities (severe sinusoidal obstruction syndrome [SOS] or Grade 4-5 pulmonary toxicity per Common Toxicity Criteria [CTC] v.4.0) during the Consolidation phase of therapy.|Up to 28 days post-consolidation therapy, up to 1 year|All eligible and evaluable patients who received at least one dose of either busulfan or melphalan.||participants|||Number
663801|NCT01797783|Secondary|Binocular Snellen Visual Acuity (VA) at Distance With Study Lenses|Visual Acuity was tested while reading a chart at 20-foot equivalent distance from the participant with both eyes together. The Snellen fraction compares the participant's result to the result expected from the ’normal’ visual system. The numerator represents the distance between the participant and the chart, and the denominator represents the distance at which a person with 'normal' vision would be able to discern the same letter size. 20/20 is considered to be 'normal' vision, whereas visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. A larger denominator, therefore, indicates a lower visual acuity.|Up to Day 30|This analysis population includes all randomized and dispensed participants who completed the study.||participants|||Number
663802|NCT01797783|Primary|Subjective Overall Vision|"The participant was instructed to, Please rate the aggregate of distance, intermediate, and near vision quality. Fill in the circle below the number that indicates your selection. Rate eyes together, marking only 1 circle for both eyes. Higher numbers mean better vision. The response was recorded on a continuous scale from 1-10 (1=poor, 10=excellent)."|Up to Day 30|"This analysis population includes all randomized and dispensed participants who completed the study. No imputation was used for missing values. Here, n is the number of participants with non-missing values at the specific time point for each arm.
group,"||Units on a scale||Standard Deviation|Mean
663803|NCT01797731|Secondary|Time Required to Utilize System|The amount of time required to utilize conventional, tibial extramedullary alignment guides versus the KneeAlignTM system, which will be recorded intraoperatively.|Minutes during surgery ( Estimated time per surgery 1 hour)|||seconds||Standard Deviation|Mean
663804|NCT01797731|Primary|Postoperative Tibial Component Alignment|The primary outcome will be the number of patients (percentage of patients) that met a predetermined criteria for Alignment as defined by within 2° of perpendicular to the tibial mechanical axis or 2° of a 3° posterior slope, postoperative tibial component alignment (mechanical varus/valgus, and posterior slope) as measured on postoperative standing anteroposterior hip-to-ankle radiographs, and standing, lateral knee-to-ankle radiographs, respectively.|6 weeks after surgery|||percentage of participants|||Number
663805|NCT01797705|Primary|% Agreement Between Reviewer and Machine Pressure Settings During Sleep Study|The primary objective for the study was demonstrating effectiveness of therapy provided by the DeVilbiss AutoAdjust device as reported by the expert human reviewer. The primary endpoint was that expert human reviewer should agree with pressure changes made by the machine during each 20-minute epoch at least 80% of the time. Expert human reviewer reviewed each study and made a determination at 20-minute time points, in context of REM/NON-REM sleep and supine/non-supine positions, marking the machine pressure response with an “agree” or “disagree.” Pressure changes might show no change, increase or decrease during the 20-minute epoch.|1 night|Subjects completing the study with evaluable results||percentage of agreement||95% Confidence Interval|Number
663806|NCT01797536|Primary|Apparent Terminal Half-Life (t1/2) of Elbasvir|Blood samples were collected at predose and Hours 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 96, 144, and 168 to determine the t1/2 of elbasvir.|Predose and Hours 0.5, 1, 2, 3, 4, , 6, 8, 12, 16, 24, 48, 96, 144, and 168|Participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment and had available data for the endpoint. Moderate arm summary excludes data for 3 participants incorrectly re-enrolled and dosed in moderate arm after completing dosing and follow-up in the mild insufficiency arm.||hr||Geometric Coefficient of Variation|Geometric Mean
663807|NCT01797536|Primary|Time to Maximum Concentration (Tmax) of Elbasvir|Blood samples were collected at predose and Hours 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 96, 144, and 168 to determine the maximum concentration (Cmax) of elbasvir. The time to reach Cmax (Tmax) was determined.|Predose and Hours 0.5, 1, 2, 3, 4, , 6, 8, 12, 16, 24, 48, 96, 144, and 168|Participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment and had available data for the endpoint. Moderate arm summary excludes data for 3 participants incorrectly re-enrolled and dosed in moderate arm after completing dosing and follow-up in the mild insufficiency arm.||hour (hr)||Full Range|Median
663808|NCT01797536|Primary|Concentration at 24 Hours (C24) After Dosing Elbasvir|Blood samples were collected at predose and Hours 0.5, 1, 2, 3, 4, 6, 8, 12, 16, and 24, to determine the concentration of elbasvir at Hour 24 was determined.|Hour 24|Participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment and had available data for the endpoint. Moderate arm summary excludes data for 3 participants incorrectly re-enrolled and dosed in moderate arm after completing dosing and follow-up in the mild insufficiency arm.||nM||95% Confidence Interval|Geometric Mean
663809|NCT01797536|Primary|Maximum Concentration (Cmax) of Elbasvir|Blood samples were collected at predose and Hours 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 96, 144, and 168 to determine the Cmax of Elbasvir.|Predose and Hours 0.5, 1, 2, 3, 4, , 6, 8, 12, 16, 24, 48, 96, 144, and 168|Participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment and had available data for the endpoint. Moderate arm summary excludes data for 3 participants incorrectly re-enrolled and dosed in moderate arm after completing dosing and follow-up in the mild insufficiency arm.||nM||95% Confidence Interval|Geometric Mean
663810|NCT01797536|Primary|Area Under the Curve From 0 to 24 Hours (AUC0-24hr) of Elbasvir|Blood samples were collected at predose and Hours 0.5, 1, 2, 3, 4, 6, 8, 12, 16, and 24 to determine the AUC0-24hr of elbasvir.|Predose and Hours 0.5, 1, 2, 3, 4, , 6, 8, 12, 16, and 24|Participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment and had available data for the endpoint. Moderate arm summary excludes data for 3 participants incorrectly re-enrolled and dosed in moderate arm after completing dosing and follow-up in the mild insufficiency arm.||μM•hr||95% Confidence Interval|Geometric Mean
663811|NCT01797536|Primary|Area Under the Curve From 0 to Infinity (AUC0-inf) of Elbasvir|Blood samples were collected at predose and Hours 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 96, 144, and 168 to determine the AUC0-inf of elbasvir.|Predose and Hours 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 96, 144, and 168|Participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment and had available data for the endpoint. Moderate arm summary excludes data for 3 participants incorrectly re-enrolled and dosed in moderate arm after completing dosing and follow-up in the mild insufficiency arm.||μM•hr||95% Confidence Interval|Geometric Mean
663818|NCT01797445|Secondary|Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 48|Urine Beta-2-microglobulin is a renal biomarker which is used to detect drug-induced kidney injury.|Baseline; Week 48|Participants in the Safety Analysis Set with available data were analyzed.||percent change in ratio (µg/g)||Inter-Quartile Range|Median
663819|NCT01797445|Secondary|Percent Change From Baseline in Urine RBP to Creatinine Ratio at Week 96|Urine RBP is a renal biomarker which is used to detect drug-induced kidney injury.|Baseline; Week 96|Participants in the Safety Analysis Set with available data were analyzed.||percent change in ratio (µg/g)||Inter-Quartile Range|Median
663820|NCT01797445|Secondary|Percent Change From Baseline in Urine Retinol Binding Protein (RBP) to Creatinine Ratio at Week 48|Urine RBP is a renal biomarker which is used to detect drug-induced kidney injury.|Baseline; Week 48|Participants in the Safety Analysis Set with available data were analyzed.||percent change in ratio (µg/g)||Inter-Quartile Range|Median
663821|NCT01797445|Secondary|Percentage of Participants With Treatment-emergent Proteinuria Through Week 96|Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method. The worst postbaseline value is presented for each participant.|Up to 96 weeks|Participants in the Safety Analysis Set with at least 1 postbaseline urine protein value were analyzed.||percentage of participants|||Number
663822|NCT01797445|Secondary|Percentage of Participants With Treatment-emergent Proteinuria Through Week 48|Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method. The worst postbaseline value is presented for each participant.|Up to 48 weeks|Participants in the Safety Analysis Set with at least 1 postbaseline urine protein value were analyzed.||percentage of participants|||Number
663823|NCT01797445|Secondary|Change From Baseline in Serum Creatinine at Week 96||Baseline; Week 96|Safety Analysis Set. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.||mg/dL||Standard Deviation|Mean
663824|NCT01797445|Secondary|Change From Baseline in Serum Creatinine at Week 48||Baseline; Week 48|Safety Analysis Set. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.||mg/dL||Standard Deviation|Mean
663825|NCT01797445|Secondary|Percent Change From Baseline in Spine BMD at Week 96|Spine BMD was assessed by DXA scan.|Baseline; Week 96|Spine DXA Analysis Set. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.||percentage change in spine BMD (g/cm^2)||Standard Deviation|Mean
663826|NCT01797445|Secondary|Percent Change From Baseline in Spine BMD at Week 48|Spine BMD was assessed by DXA scan.|Baseline; Week 48|Spine DXA Analysis Set. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.||percentage change in spine BMD (g/cm^2)||Standard Deviation|Mean
663827|NCT01797445|Secondary|Percent Change From Baseline in Hip BMD at Week 96|Hip BMD was assessed by DXA scan.|Baseline; Week 96|Hip DXA Analysis Set. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.||percentage change in hip BMD (g/cm^2)||Standard Deviation|Mean
663828|NCT01797445|Secondary|Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48|Hip BMD was assessed by dual energy x-ray absorptiometry (DXA) scan.|Baseline; Week 48|Hip DXA Analysis Set. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.||percentage change in hip BMD (g/cm^2)||Standard Deviation|Mean
663829|NCT01797445|Secondary|Change From Baseline in CD4+ Cell Count at Week 96||Baseline; Week 96|Participants in the Full Analysis Set with available data were analyzed.||cells/µL||Standard Deviation|Mean
663830|NCT01797445|Secondary|Change From Baseline in CD4+ Cell Count at Week 48||Baseline; Week 48|Participants in the Full Analysis Set with available data were analyzed.||cells/µL||Standard Deviation|Mean
663831|NCT01797445|Secondary|Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Weeks 48 and 96|The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Weeks 48 and 96 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Weeks 48 and 96|Full Analysis Set||percentage of participants|||Number
663832|NCT01797445|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 96|Full Analysis Set||percentage of participants|||Number
663833|NCT01797445|Primary|Percentage of Participants Achieving HIV-1 RNA < 50 Copies/mL at Week 48|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Full Analysis Set: participants were randomized and received at least one dose of study drug||percentage of participants|||Number
663834|NCT01797380|Primary|Reduction in Depressive Symptoms|Depressive symptoms were assessed by questionaire at baseline and finally at the end of the study at 9 weeks.|9 weeks.|Terminated due to lack of recruitment. Five subjects were consented for the trial, but were not able to complete study or generate analyzable data.|||||
663835|NCT01797328|Primary|Brown Adipose Tissue, Absolute Volume|Sub-clavicular brown adipose tissue volume by magnetic resonance imaging (liters)|Baseline and 6 week|Brown adipose tissue volume (liters)||liters||Standard Deviation|Mean
663851|NCT01797029|Secondary|Percentage of Participants With Symptomatic, Laboratory-confirmed Influenza Virus Infection (Vaccine-matched Strains).||Through 16 to 19 months post-vaccination||||||
663847|NCT01797029|Other Pre-specified|Percentage of Participants With Symptomatic, Laboratory-confirmed Influenza Virus Infection (All Strains) Among Children||From approx. 6 months to approximately 19 months post-vaccination||||||
663848|NCT01797029|Other Pre-specified|Percentage of Participants With Symptomatic, Laboratory-confirmed Influenza Virus Infection (Vaccine-matched Strains) Among Children||From approx. 6 months to approximately 19 months post-vaccination||||||
663849|NCT01797029|Other Pre-specified|Percentage of Participants With Moderate to Severe, Laboratory-confirmed Influenza Virus Infection Among Children||Through 16 to 19 months post-vaccination||||||
663863|NCT01796977|Secondary|To Evaluate Scar Formation 30 Days Post Nipple-sparing Mastectomy|"Patient and Observer Scar Assessment Scale - range = 1 - 10. 1 is best condition (normal skin) and 10 is worst condition (worst scar imaginable). The scale is used to assess each of six different wound characteristics, including vascularity, pigmentation, thickness, relief, pliability, and surface area. The means of these combined scores and their respective standard deviations are reported for each study group. The range of the final evaluation score, based on the collective evaluation of each of the six wound characteristics is 6 (if each of the six scores equals 1) to 60 (if each of the six scores equals 10)."|30 days post nipple-sparing mastectomy|Each participant acted as her own control - one breast received OxyGenesys, while the other breast received the standard dressing. Two patients in the OxyGenesys study arm, and one patient in the Control study arm did not provide follow-up data.||units on a scale||Full Range|Mean
663864|NCT01796977|Secondary|To Assess Pain Using the Numerical Rating Scale|"Numerical Rating Scale (NRS) - range = 0 - 10. 0 corresponds to no pain and 10 indicates worst pain imaginable. The means of these scores and their respective standard deviations are reported for each study group."|30 days|There is just one NRS value calculated for the indicated time-frame, and thus a comparison between study groups with respect to this outcome was not made. The single NRS value at 30 days is reported here. One patient did not provide follow-up data at this time-point, and thus the total number of participants is 26 instead of 27 for this outcome.||units on a scale||Standard Deviation|Mean
663865|NCT01796977|Secondary|To Evaluate Scar Formation 30 Days Post Nipple-sparing Mastectomy|"Patient and Observer Scar Assessment Scale - range = 1 - 10. 1 is best condition (normal skin) and 10 is worst condition (worst scar imaginable). The scale is used to assess each of six different wound characteristics, including vascularity, pigmentation, thickness, relief, pliability, and surface area. The means of these combined scores and their respective standard deviations are reported for each study group. The range of the final evaluation score, based on the collective evaluation of each of the six wound characteristics is 6 (if each of the six scores equals 1) to 60 (if each of the six scores equals 10)."|30 days post nipple-sparing mastectomy|Each participant acted as her own control - one breast received OxyGenesys, while the other breast received the standard dressing. Two patients in the OxyGenesys study arm, and one patient in the Control study arm did not provide follow-up data.||units on a scale||Standard Deviation|Mean
663866|NCT01796977|Primary|Evaluate the Effects of OxyGenesys Dissolved Oxygen Dressing in Wound Complication Rates of the Nipple Areolar Complex Post Nipple-sparing Mastectomy|Wound Complication Rate|30 days|Each participant acted as her own control - one breast of each participant received the OxyGenesys Dressing, the other breast received the standard dressing.||breasts|Participants||Number
663867|NCT01796964|Secondary|Central Subfield Thickness (CSFT) Change From Baseline by Visit|CSFT (average thickness in the central subfield centered at the fovea) as measured using Spectral-Domain Optical Coherence Tomography (SD-OCT). Reduction in CSFT measurement from baseline indicates improvement. One eye (study eye) contributed to the analysis.|Baseline (Day 0), Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56|This analysis population includes all subjects who were randomized, received at least 1 treatment, had a baseline value, and had at least 1 postbaseline measurement of the primary efficacy variable, BCVA. Subjects were analyzed according to the actual treatment received with LOCF imputation of missing values.||microns||Standard Deviation|Mean
663868|NCT01796964|Secondary|Two-Months BCVA Changes (No. of Letters) Following No Treatment for 1 Month in ESBA Treatment Group|BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. This outcome measure was pre-specified for ESBA1008 arm only. One eye (study eye) contributed to the analysis.|Week 36, Week 44, Week 48, Week 56|This analysis population includes all subjects who were randomized, received at least 1 treatment, had a baseline value, and had at least 1 postbaseline measurement of the primary efficacy variable, BCVA. Subjects were analyzed according to the actual treatment received with LOCF imputation of missing values.||letters||Standard Deviation|Mean
663869|NCT01796964|Secondary|One-Month BCVA Changes (No. of Letters) Following Treatment by Visit|The purpose of this outcome measure was to assess the potential treatment needs present at these treatment visits. BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.|Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52|This analysis population includes all subjects who were randomized, received at least 1 treatment, had a baseline value, and had at least 1 postbaseline measurement of the primary efficacy variable, BCVA. Subjects were analyzed according to the actual treatment received with LOCF imputation of missing values.||letters||Standard Deviation|Mean
663870|NCT01796964|Secondary|One-Month BCVA Changes (No. of Letters) Following No Treatment for 1-Month|The purpose of this outcome measure was to assess the stability of BCVA during the second month of 8-week/12-week treatment cycles and specifically to identify potential under treatment. BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.|Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56|This analysis population includes all subjects who were randomized, received at least 1 treatment, had a baseline value, and had at least 1 postbaseline measurement of the primary efficacy variable, BCVA. Subjects were analyzed according to the actual treatment received with LOCF imputation of missing values.||letters||Standard Deviation|Mean
663881|NCT01796548|Secondary|Total Incontinence Episodes|Episodes of total urinary incontinence were reported. Urinary incontinence is the complaint of any involuntary leakage of urine.|Baseline, Week 4 and Week 12|"ITT population. Here n signifies participants who were evaluable for this measure at a particular time point. This study is early terminated and there were some missing data for total incontinence which lead to decrease value of total incontinence."||Episodes||Standard Deviation|Mean
663882|NCT01796548|Secondary|Urge Incontinence Episodes|Urge incontinence episodes were reported. Urge urinary incontinence is the complaint of involuntary leakage accompanied by or immediately preceded by urgency with sudden feeling to go to toilet.|Baseline, Week 4 and Week 12|"ITT population. Here n signifies participants who were evaluable for this measure at a particular time point."||Episodes||Standard Deviation|Mean
663871|NCT01796964|Secondary|Average BCVA Change From Week 12 (No. of Letters) Over the Periods of Week 16 to Week 24, Week 16 Week 40, and Week 16 to Week 56|The purpose of this outcome measure was to assess the average maintenance level of BCVA following the 3 loading treatments (ie, after Week 12). BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. These changes were computed as the average of the changes from Week 12 to each monthly study visit corresponding to each period. One eye (study eye) contributed to the analysis.|Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56|This analysis population includes all subjects who were randomized, received at least 1 treatment, had a baseline value, and had at least 1 postbaseline measurement of the primary efficacy variable, BCVA. Subjects were analyzed according to the actual treatment received with LOCF imputation of missing values.||letters||Standard Deviation|Mean
663872|NCT01796964|Secondary|Average BCVA Change From Baseline (No. of Letters) Over the Periods of Week 4 to Week 16, Week 4 to Week 24, Week 4 to Week 40, and Week 4 to Week 56|The purpose of this outcome measure was to assess the integrated effect of the treatment for different study periods and to provide more robust estimate of the absolute treatment effects. BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. These changes were computed as the average of the changes from baseline to each monthly study visit corresponding to each period. One eye (study eye) contributed to the analysis.|Baseline (Day 0), Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56|This analysis population includes all subjects who were randomized, received at least 1 treatment, had a baseline value, and had at least 1 postbaseline measurement of the primary efficacy variable, BCVA. Subjects were analyzed according to the actual treatment received with LOCF imputation of missing values.||letters||Standard Deviation|Mean
663873|NCT01796964|Secondary|BCVA Change From Baseline (No. of Letters) by Visit|BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.|Baseline (Day 0), Week 4, Week 8, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56|This analysis population includes all subjects who were randomized, received at least 1 treatment, had a baseline value, and had at least 1 postbaseline measurement of the primary efficacy variable, BCVA. Subjects were analyzed according to the actual treatment received with LOCF imputation of missing values.||letters||Standard Deviation|Mean
663874|NCT01796964|Secondary|BCVA Change From Baseline (No. of Letters) to Week 16|BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.|Baseline (Day 0), Week 16|This analysis population includes all subjects who were randomized, received at least 1 treatment, had a baseline value, and had at least 1 postbaseline measurement of the primary efficacy variable, BCVA. Subjects were analyzed according to the actual treatment received with LOCF imputation of missing values.||letters||Standard Deviation|Mean
663875|NCT01796964|Primary|Best-Corrected Visual Acuity (BCVA) Change From Baseline (No. of Letters) to Week 12|This outcome measure was used to compare the ESBA1008 and EYLEA groups in regards to fluctuations in treatment effect during the maintenance phase with 8-week treatment cycles (ie, to evaluate treatment effect stability during the maintenance phase). BCVA (with spectacles or other visual corrective devices) using Early Treatment Diabetic Retinopathy Study (ETDRS) testing was reported in letters read correctly. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.|Baseline (Day 0), Week 12|This analysis population includes all subjects who were randomized, received at least 1 treatment, had a baseline value, and had at least 1 postbaseline measurement of the primary efficacy variable, BCVA. Subjects were analyzed according to the actual treatment received with LOCF imputation of missing values.||letters||Standard Deviation|Mean
663876|NCT01796860|Other Pre-specified|Change in Walking Endurance Using a 6-Minute Walk Test (6MWT) From Initial Testing to Final Testing|Each participant will be asked to walk at a self-selected velocity on level surfaces for 6 minutes. They will be allowed to use assistive devices as necessary.|6MWT will be done at the time of enrollment and week 13.|||meters||Standard Deviation|Mean
663877|NCT01796860|Secondary|Number of Participants With Change in Muscle Activity With Surface Electromyography (EMG) of Key Lower Extremity Muscles From Baseline to Final Testing|Surface electromyography will be done on key muscles in the lower extremity (quadriceps, anterior tibialis, gastrocnemius) during computerized gait assessment. Changes in muscle activity would be things like large changes in amplitude of muscle firing or changes in the timing of muscle firing, for example. These would indicate changes in strength or perhaps motor learning as a result of wearing the ankle foot orthosis.|Surface EMG will be done at the time of enrollment and week 13.|||participants|||Number
663878|NCT01796860|Primary|Change in Step Length From Initial Testing to End of Study|Participants will be asked to walk on a 12-16 foot long vinyl pad placed on the floor. The mat will record and analyze step length.|Computerized gait analysis will be done at the time of enrollment and week 13.|||measure of length (cm)||Standard Deviation|Mean
663879|NCT01796548|Secondary|King Health Questionnaire Score|King Health Questionnaire assesses the physical and psycho-social aspects of the disease state. It is a self-administered questionnaire containing 21 questions scored in 9 domains (general health perception, incontinence impact, role limitations, physical limitations, social limitations, personal relationships, emotions, sleep or energy, and severity of urinary symptoms). All domains were assessed in a range: 0-100, where 0=best outcome/response and 100=worst outcome or response. Lower scores indicates better outcome or response.|Baseline and Week 12|"ITT population. Here N signifies participants who were evaluable for this measure."||Units on a scale||Standard Deviation|Mean
663880|NCT01796548|Secondary|Percentage of Participants With no Episodes of Urge-Urinary Incontinence|Percentage of participants with no episodes of urge urinary incontinence was reported. Urge urinary incontinence is the complaint of involuntary leakage accompanied by or immediately preceded by urgency.|Baseline, Week 4 and Week 12|Data was not reported for this OM, as data was not analyzed because of change in the planned analysis of the study.|||||
663884|NCT01796548|Secondary|Post-Void Residual Urine Volume|Post-void residual urine volume is the amount of urine remaining in the bladder after void completion.|Baseline and Week 12|"ITT population. Here N (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for this measure at a particular time point."||Milliliter (ml)||Standard Error|Mean
663885|NCT01796548|Secondary|Detrusor Leakpoint Pressure|Detrusor leakpoint pressure is the level of pressure at which leakage of urine through the urethra occurs as the bladder fills without an increase in abdominal pressure. This was a measure of both strength of the urethral sphincters and compliance of the detrusor muscle.|Baseline and Week 12|Data for this outcome measure is not reported because the data was not collected and included in Case Report Form (CRF).|||||
663886|NCT01796548|Secondary|Maximal Cystometric Capacity (MCC)|MCC represents the maximum volume of urine the bladder holds.|Baseline and Week 12|ITT population.||Milliliter (ml)||Standard Deviation|Mean
663887|NCT01796548|Primary|Maximal Detrusor Pressure|Maximal detrusor pressure represents the maximum pressure (peak amplitude) in the bladder during the first involuntary contraction of the bladder muscle. Detrusor pressure is the component of intravesical (in the bladder) pressure that is created by forces in the bladder wall (passive and active). It was estimated by subtracting abdominal pressure from intravesical pressure.|Week 12|The Intent-to treat (ITT) population included all randomly assigned participants who received at least 1 dose of study medication and fulfilled all eligibility criteria.||Centimeter of water||Standard Deviation|Mean
663888|NCT01796236|Secondary|Inflammation|Max of Holgers index from day 10 to month 12 was recorded, using the Holgers scale from 0 - 4, where 0 = no inflammation and 4 = removal of abutment/implant necessary due to infection.|Day 10 to 12 Months|The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and onward.||participants|||Number
663889|NCT01796236|Secondary|Surgery Time|Surgery time (minutes) was recorded|Day 0|The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and onward.||minutes||Standard Deviation|Mean
663890|NCT01796236|Secondary|Wound Healing|A surgeon or a surgical nurse determined if the wound was healed or not healed.|Day 10, Weeks 3, 6, 12 and 24|The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and onward. There was only a statistically significant difference between the two groups in this population at day 10.||participants|||Number
663891|NCT01796236|Secondary|Pain in the Scar and Neuropathic Pain|The subject rated the following questions ‘has the scar been painful the past few weeks’ and ‘have you had any neuropathic pain during the past weeks’ on the 1-10 scale were 1 = no, not at all and 10 = yes, very much.|Day 10, Weeks 3, 6, 12, 24 and Month 12|The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and onward. There were only statistically significant differences between the two groups in this population at 3 and 12 weeks and only regarding neuropathic pain.||units on a scale||Standard Deviation|Mean
663892|NCT01796236|Secondary|Numbness|Numbness summary analysis.|12 months|The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and onward.||participants|||Number
663893|NCT01796236|Primary|Number of Participants With Local Adverse Events as a Measure of Safety and Tolerability|"Combined endpoint of infection/inflammation, overgrowth, pain and numbness will be evaluated, as the sum of the following four events:
Holgers Index >=2 any time between 3 weeks to 1 year
Any overgrowth any time between 3 weeks to 1 year
Pain (scar/neuropathic) according to POSAS >=3 any time between 3 weeks to 1 year
Any numbness any time between 3 weeks to 1 year Each medical event is counted only once per subject resulting in a score of 0 to 4 for every subject."|12 months|The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and onward.||participants|||Number
663894|NCT01795937|Secondary|AUC0-tz of Rosuvastatin|"Area under the plasma concentration-time curve of the analyte over the time interval from 0 to the time tz of the last measurable concentration (AUC0-tz) of rosuvastatin. Outcome measure for the statins part of this trial, treatment sequence E_F.
The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|-1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of rosuvastatin on Day 1 of both periods|PK set of the statins part and assigned to rosuvastatin (treatment sequence E_F).||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
663895|NCT01795937|Primary|Cmax of Rosuvastatin|"Maximum measured concentration of the analyte in plasma of rosuvastatin (Cmax). Outcome measure for the statins part of this trial, treatment sequence E_F.
The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|-1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of rosuvastatin on Day 1 of both periods|PK set of the statins part and assigned to rosuvastatin (treatment sequence E_F).||ng/mL||Geometric Coefficient of Variation|Geometric Mean
663896|NCT01795937|Primary|AUC0-∞ of Rosuvastatin (Statins Part)|"Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) of rosuvastatin after single dose administration of rosuvastatin. Outcome measure for the statins part of this trial, treatment sequence E_F.
The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|-1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of rosuvastatin on Day 1 of both periods|PK set of the statins part and assigned to rosuvastatin (treatment sequence E_F).||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
663897|NCT01795937|Secondary|AUC0-tz of Atorvastatin|"Area under the plasma concentration-time curve of the analyte over the time interval from 0 to the time tz of the last measurable concentration (AUC0-tz) of atorvastatin. Outcome measure for the statins part of this trial, treatment sequence C_D.
The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|-1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of atorvastatin on Day 1 of both periods|PK set of the statins part and assigned to atorvastatin (treatment sequence C_D).||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
663898|NCT01795937|Secondary|Cmax,ss of Faldaprevir (Statins Part)|Maximum measured concentration of the analyte in plasma at steady state over the dosing interval (Cmax,ss) of faldaprevir. Outcome measure for the statins part of this trial, treatment sequences C_D and E_F.|-1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of rosuvastatin/atorvastatin on Day 1 of the second periods of each treatment sequence.|PK set of the statins part.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
663899|NCT01795937|Secondary|AUCτ,ss of Faldaprevir (Statins Part)|Area under the concentration-time curve of the analyte in plasma at steady state over the dosing interval τ (AUCτ,ss) of faldaprevir. Outcome measure for the statins part of this trial, treatment sequences C_D and E_F.|-1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of rosuvastatin/atorvastatin on Day 1 of the second periods of each treatment sequence.|PK set of the statins part.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
663900|NCT01795937|Primary|Cmax of Atorvastatin (Statins Part)|"Maximum measured concentration of the analyte in plasma of atorvastatin (Cmax). Outcome measure for the statins part of this trial, treatment sequence C_D.
The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|-1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of atorvastatin on Day 1 of both periods|PK set of the statins part and assigned to atorvastatin (treatment sequence C_D).||ng/mL||Geometric Coefficient of Variation|Geometric Mean
663901|NCT01795937|Primary|AUC0-∞ of Atorvastatin (Statins Part)|"Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) of atorvastatin after single dose administration. Outcome measure for the statins part of this trial, treatment sequence C_D.
The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|-1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of atorvastatin on Day 1 of both periods.|"PK set of the statins part and assigned to atorvastatin (treatment sequence C_D).
Pharmacokinetic set (PK set): all treated subjects of the statins part that provided at least 1 observation for at least 1 primary endpoint without important protocol violations with respect to the statistical evaluation of the pharmacokinetic endpoints."||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
663902|NCT01795937|Primary|Cmax,ss (Itraconazole Part)|"Maximum measured concentration of the analyte in plasma at steady state over the dosing interval (Cmax,ss) of faldaprevir. Outcome measure for the itraconazole part (Treatment sequence A_B) of this trial.
The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|-1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00 h after administration of faldaprevir on Day 1 of both periods.|PK set of the itraconazole part of this trial.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
663903|NCT01795937|Primary|AUCτ,ss (Itraconazole Part)|Area under the concentration-time curve of the analyte in plasma at steady state over the dosing interval τ (AUCτ,ss) of faldaprevir. Outcome measure for the itraconazole part (treatment sequence A_B) of this trial. The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.|-1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00 h (hours) after administration of faldaprevir on Day 1 of both periods|pharmacokinetic (PK) set of the itraconazole part of this trial. The PK set included all treated subjects of the itraconazole part that provided at least 1 observation for at least 1 primary endpoint without important protocal violations with respect to the statistical evaluation of the PK endpoints.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
663904|NCT01795898|Primary|Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Participant|CGI-I is a 7-point scale that requires the Participant to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.|Day 30|The ITT population was defined as all the participants who received at least 1 dose of study medication and had at least 1 follow-up visit with assessment.||Participants|||Number
663905|NCT01795898|Primary|Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Clinician|CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.|Day 30|The ITT population was defined as all the participants who received at least 1 dose of study medication and had at least 1 follow-up visit with assessment.||Participants|||Number
663906|NCT01795898|Primary|Number of Participants Requiring Rescue Medication|Rescue medications are periodic supplemental doses of analgesic which might be required to control pain. Tramadol 50mg tablet at a maximum of 6 tablets per day was used as standard rescue medication.|Day 30|All participants suffering from osteoarthritis (disorder, which is seen mostly in older persons, in which the joints become painful and stuff) and chronic (lasting a long time) low back pain and who took at least 1 dose of study medication and had at least 1 follow-up visit during the study.||Participants|||Number
663907|NCT01795898|Primary|Change From Baseline in Brief Pain Inventory (BPI) Interference Score at Day 30|BPI is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions. BPI-interference consists of 7 questions (items) that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each question (item) is answered on a scale ranging from 0 to 10; ‘0=No pain and 10=Pain as bad as you can imagine’. Measure can be scored by item, with lower scores being indicative of less pain or pain interference. Change: Score at Day 30 minus score at Baseline.|Baseline and Day 30|The ITT population was defined as all the participants who received at least 1 dose of study medication and had at least 1 follow-up visit with assessment.||Units on a scale||Standard Deviation|Mean
663986|NCT01792830|Secondary|Readmission Rate to the Hospital|Number of subjects that were readmitted to the hospital 3 months after discharge|3 months after discharge|The numbers listed are reflective of the total number of subjects who remained in the study at the 3 months after discharge time period. Many of the subjects were lost to follow up or never returned for their post-operative visit.||participants|||Number
663908|NCT01795898|Primary|Change From Baseline in Brief Pain Inventory (BPI) Severity Score at Day 30|BPI is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions. BPI- severity consists of 4 questions (items) that assess pain intensity (worst, least, average, right now). Each question (item) is answered on a scale ranging from 0 to 10; ‘0=No pain and 10=Pain as bad as you can imagine’. Measure can be scored by item, with lower scores being indicative of less pain or pain interference. Change: Score at Day 30 minus score at Baseline.|Baseline and Day 30|The intent-to-treat (ITT) population was defined as all the participants who received at least 1 dose of study medication and had at least 1 follow-up visit with assessment.||Units on a scale||Standard Deviation|Mean
663909|NCT01795859|Secondary|Change in Berg Balance Test (BBT)|The Berg Balance Test (BBT) is a 14-item assessment of sitting, standing, transferring, and turning. Each task ranging from standing up from a sitting position, to standing on one foot each task is given a score of zero (unable) to four (independent), and the final measure is the sum of all of the scores.The scale range, which is 0-56, with higher scores indicating better balance/lower fall risk.|Baseline, 12 weeks|The Modified ITT (mITT) Population was defined as all subjects in the ITT Population who received study drug and had at least one postbaseline assessment. For subjects with missing value at Week 12, the last available assessment was used||units on a scale||Standard Deviation|Least Squares Mean
663910|NCT01795859|Secondary|Change in the Short Form 36 Health Survey (SF-36) Physical Functioning Score (Based on Items 3a to 3j) From Baseline to Week 12|Change in the Short Form 36 Health Survey (SF-36) physical functioning score (based on items 3a to 3j) from Baseline to Week 12. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.|Baseline, 12 weeks|The modified intent to treat (mITT) population will include all subjects in the ITT population who were randomized to treatment and received study drug. For subjects with missing value at Week 12, the last available assessment was used||units on a scale||Standard Deviation|Mean
663911|NCT01795859|Secondary|Number of Participants With Treatment Success at the End of Therapy Based on Clinical Global Impression of Change (CGIC)|A treatment success is defined as Much or Very Much Improved at the Week 12 visit. The PGIC is a 7-point Likert Scale, ranging from very much worse to very much improved. The clinician was asked to comment about the subject.|12 weeks|The Modified ITT (mITT) Population was defined as all subjects in the ITT Population who received study drug and had at least one post-baseline assessment.||Participants|||Count of Participants
663912|NCT01795859|Secondary|Number of Participants With Treatment Success at the End of Therapy as Measured by the Patient Global Impression of Change (PGIC)|A treatment success is defined as Much or Very Much Improved at the Week 12 visit. The PGIC is a 7-point Likert Scale, ranging from very much worse to very much improved|12 weeks|The Modified ITT (mITT) Population was defined as all subjects in the ITT Population who received study drug and had at least one post baseline assessment.||Participants|||Count of Participants
663913|NCT01795859|Primary|Change From Baseline (Average of Screening and Day 0) in the Average TMC Scores From Weeks 9 & 12|Total TMC score is a sum of chorea scores which range 0-28, with a decrease indicating improvement in chorea|Screening, Day 0, Weeks 9, 12|The Modified ITT (mITT) Population was defined as all subjects in the ITT Population who received study drug and had at least one postbaseline assessment. For subjects who missed both Week 9 or Week 12 scores, the last available assessment was used||Units on a scale||Standard Deviation|Least Squares Mean
663914|NCT01795716|Primary|Area Under Curve (AUC) Time Frame: Predose, 0.5,1,1.5,2,3,5,8,12,24,48,72hours Post-dose||predose, 0.5,1,1.5,2,3,5,8,12,24,48,72hours post-dose|||mcg*hr/mL||Standard Deviation|Mean
663915|NCT01795547|Secondary|Change From Baseline to Week 28 in the TooL Total Score|Tolerability and Quality of Life (TooL) is a patient-rated scale developed to measure the impact of side-effects on the quality of life in patients treated with antipsychotic medication. The TooL consists of 8 domains: mood (worry-upset), function capabilities, fatigue-weakness, weight gain, stiffness-tremor, physical restlessness, sexual dysfunction, and dizziness-nausea. Each domain was rated on a four-point scale from 1 (no impact) to 4 (maximum impact). Total scores ranged from 8 (no impact) to 32 (maximum impact).|Baseline, Week 28|Effectiveness data is based on all patients who received study medicine, who had a valid baseline assessment, and at least 1 valid post-baseline assessment of the QLS (Full analysis set). Effectiveness was measured at Weeks 0, 4, 8, 16, and 28.||units on a scale||Standard Error|Least Squares Mean
663916|NCT01795547|Secondary|Change From Baseline to Week 28 in SWN-S Total Score|The SWN-S is a patient-rated scale designed to measure subjective effects of neuroleptic drugs to psychopathology, quality of life, and compliance over the past 7 days. The 20 items (10 positive and 10 negative statements) are grouped in 5 subscales (mental functioning, self-control, physical functioning, emotional regulation and social integration). Each subscale contains 4 items. Each item was rated on a six-point Likert scale, from not at all to very much. A score was calculated for each subscale, and the total score ranged from 20 to 120, where the higher score indicated better well-being.|Baseline, Week 28|Effectiveness data is based on all patients who received study medicine, who had a valid baseline assessment, and at least 1 valid post-baseline assessment of the QLS (Full analysis set). Effectiveness was measured at Weeks 0, 4, 8, 16, and 28.||units on a scale||Standard Error|Least Squares Mean
663917|NCT01795547|Secondary|Change From Baseline to Week 28 in the 'Instrumental Role' QLS Domain Score|The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Instrumental Role domain score was calculated as the sum of 4 items (numbers 9 to 12) giving a range of 0 to 24, where the higher score indicated less unimpaired functioning.|Baseline, Week 28|Effectiveness data is based on all patients who received study medicine, who had a valid baseline assessment, and at least 1 valid post-baseline assessment of the QLS (Full analysis set). Effectiveness was measured at Weeks 0, 4, 8, 16, and 28.||units on a scale||Standard Error|Least Squares Mean
663999|NCT01792635|Primary|Whole-body Glucose Uptake in Part B in Placebo Group|Whole-body glucose uptake (Rate of glucose disappearance, Rd) during the Step 2 Clamp|6 weeks|Part B of the study was terminated due to the safety issue. Due to the limited participant number who completed study there no summary statistics were done by dosing regimen for Part B.||mg/kg BW/min||Full Range|Mean
663918|NCT01795547|Secondary|Change From Baseline to Week 28 in the 'Interpersonal Relations' QLS Domain Score|The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Interpersonal Relations domain score was calculated as the sum of 8 items (numbers 1 to 8) giving a range of 0 to 48, where the higher score indicated less unimpaired functioning.|Baseline, Week 28|Effectiveness data is based on all patients who received study medicine, who had a valid baseline assessment, and at least 1 valid post-baseline assessment of the QLS (Full analysis set). Effectiveness was measured at Weeks 0, 4, 8, 16, and 28.||units on a scale||Standard Error|Least Squares Mean
663919|NCT01795547|Secondary|Change From Baseline to Week 28 in the 'Intrapsychic Foundations' QLS Domain Score|The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Intrapsychic Foundations domain score was calculated as the sum of 7 items (numbers 13 to 17 and 20 and 21) giving a range of 0 to 42, where the higher score indicated less unimpaired functioning.|Baseline, Week 28|Effectiveness data is based on all patients who received study medicine, who had a valid baseline assessment, and at least 1 valid post-baseline assessment of the QLS (Full analysis set). Effectiveness was measured at Weeks 0, 4, 8, 16, and 28.||units on a scale||Standard Error|Least Squares Mean
663920|NCT01795547|Secondary|Change From Baseline to Week 28 in the 'Common Objects and Activities' QLS Domain Score|The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Common Objects and Activities domain score was calculated as the sum of 2 items (numbers 18 and 19) giving a range of 0 to 12, where the higher score indicated less unimpaired functioning.|Baseline, Week 28|Effectiveness data is based on all patients who received study medicine, who had a valid baseline assessment, and at least 1 valid post-baseline assessment of the QLS (Full analysis set). Effectiveness was measured at Weeks 0, 4, 8, 16, and 28.||units on a scale||Standard Error|Least Squares Mean
663921|NCT01795547|Secondary|Change From Baseline to Week 28 in CGI-S Score|Clinical Global Impression - Severity of Illness (CGI-S) score provides the clinician’s impression of the patient’s current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient’s current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients).|Baseline, Week 28|Effectiveness data is based on all patients who received study medicine, who had a valid baseline assessment, and at least 1 valid post-baseline assessment of the QLS (Full analysis set). Effectiveness was measured at Weeks 0, 4, 8, 16, and 28.||units on a scale||Standard Error|Least Squares Mean
663922|NCT01795547|Secondary|Investigator’s Assessment Questionnaire (IAQ) Total Score at Week 28|The IAQ is a clinician-rated scale designed to assess the relative effectiveness (efficacy, safety and tolerability) of antipsychotic medications in patients with schizophrenia or schizoaffective disorder. The IAQ consists of 12 items: positive symptoms, negative symptoms, other efficacy symptoms, cognition, energy, mood, somnolence, weight gain, signs and symptoms of prolactin elevation, akathisia, EPS (other than akathisia) and other safety or tolerability issues. For each item, the current medication was compared with previous antipsychotic medication on a five-point scale from 1 (Much better) to 5 (Much worse), or that item is Not applicable. The sum of the 12 items ranged from 12 (the current medication was much better than previous antipsychotic medication) to 60 (the current medication was much worse than previous antipsychotic medication).|Week 28|Effectiveness data is based on all patients who received study medicine, who had a valid baseline assessment, and at least 1 valid post-baseline assessment of the QLS (Full analysis set). Effectiveness was measured at Weeks 4, 8, 16, and 28. Since the IAQ was assessed from week 4, the analysis was based on 133 and 131 patients||units on a scale||Standard Error|Least Squares Mean
663923|NCT01795547|Primary|Change From Baseline to Week 28 in Quality of Life Scale (QLS) Total Score|The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). Definitions were provided for 4 anchor points of the 7 points. Each item had a brief description of the judgement to be made and a set of suggested probes for the clinician. The total score was calculated as the sum of all 21 items giving a range of 0 to 126, where the higher score indicated normal or unimpaired functioning.|Baseline, Week 28|Effectiveness data is based on all patients who received study medicine, who had a valid baseline assessment, and at least 1 valid post-baseline assessment of the QLS (Full analysis set). Effectiveness was measured at Weeks 0, 4, 8, 16, and 28.||units on a scale||Standard Error|Least Squares Mean
663924|NCT01795534|Primary|Time to Complete a 10 km Run|Time taken following consumption of beetroot shot or consumption of placebo shot|Period 1 (on day of 1st intervention) and period 2 (on day of 2nd intervention)|||Seconds||Standard Deviation|Mean
663925|NCT01794949|Primary|Percent Stent Coverage|Assessment of vascular healing 6 months after Resolute Integrity placement in non-diabetic patients and patients with non-insulin dependent diabetes presenting with acute coronary syndrome (ACS) using optical frequency domain imaging (OFDI). Vascular healing will be measured by percent covered stents as determined by OFDI. A higher percentage of stent coverage indicates increased endothelial regrowth, which is an essential component for the maintenance of long-term luminal patency.|6 months|Participants included in the analyses for this outcome are those who completed the 6 month follow-up imaging to assess vascular healing. Optical frequency domain imaging (OFDI) was not performed on two participants in the non-diabetic study arm.||Participants|||Count of Participants
663926|NCT01794936|Primary|Prevalence of Intra-operative Complications|Investigators will evaluate whether any intra-operative complications resulted from the use of the VTI probe to assess safety. Specifically, this time frame is limited from the induction of anesthesia through the completion of the surgical procedure (typically ~2-3 hours)|During surgical procedure itself (~2-3 hours)|The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in February 2012.|||||
663927|NCT01794936|Primary|Change in SHIM Score (Score of Erectile Function) Following Surgery|Patients are to be evaluated for erectile function at 8 month post-operative visit using validated SHIM questionnaire.|8 months post-operative follow-up|The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in February 2012.|||||
663928|NCT01794845|Secondary|Estimated Overall Survival (OS)|Overall survival (OS) is defined as the length of time from the start of treatment that study participants diagnosed with the disease are still alive. OS will be measured from the start date of treatment to the date of death or last contact (censored observations).|Up to 6 years|At the time of study termination in June 2016, 1 patient had already died, 1 patient had refused follow-up, 1 patient was lost to follow-up and 1 patient was alive with disease. Overall survival data were not analyzed due to an insufficient number of evaluable participants accrued and early study termination for lack of efficacy.|||||
663929|NCT01794845|Secondary|Estimated Progression-Free Survival (PFS)|Progression-free survival (PFS) is defined of the length of time from the start date of treatment to the earliest documented occurrence of disease progression according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) criteria. In the absence of an event constituting failure, follow up time will be censored at the date of last disease assessment.|Up to 6 years|At the time of study termination in June 2016, 1 patient had already died, 1 patient had refused follow-up, 1 patient was lost to follow-up and 1 patient was alive with disease. Progression-free survival data were not analyzed due to an insufficient number of evaluable participants accrued and early study termination for lack of efficacy.|||||
663930|NCT01794845|Secondary|Number of Study Participants Experiencing Treatment-Related Toxicity|"Assess the safety profile (acute and late toxicities) of the proposed treatment. Number of study participants experiencing treatment-related acute and late toxicity:
Acute toxicity is defined as toxicity occurring within 90 days of start of therapy.
Late/Long-term toxicity defined as toxicity occurring more than 90 days after start of therapy."|Up to 6 years|Data for 4 of 5 participants analyzed due to 1 subject withdrawing prior to receiving protocol therapy.||Participants|||Count of Participants
663931|NCT01794845|Primary|Overall Response Rate (ORR) of Participants|ORR is defined as the rate of study participants achieving complete response (CR) or partial response (PR) to protocol therapy according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) criteria.|Up to 6 months from End of Treatment, about 9 months|Data for 4 of 5 participants analyzed due to 1 subject withdrawing prior to receiving protocol therapy.||percentage of participants|||Number
663932|NCT01794806|Secondary|Changes in Apico-coronal Ridge Dimension|Linear ridge height change at the mid-facial aspect of the ridge|Week 14 after tooth extraction|||millimeters||Inter-Quartile Range|Median
663933|NCT01794806|Secondary|Changes in Bucco-lingual Ridge Dimension|Linear ridge width change at the bone crest|Baseline to Week 14 after tooth extraction|||millimeters||95% Confidence Interval|Mean
663934|NCT01794806|Primary|Alveolar Ridge Volumetric Changes|3D reconstructions using radiographic data obtained at baseline and at 14 weeks after the intervention was utilized to calculate the reduction of bone volume that took place during the healing period in both groups|Baseline to Week 14 after tooth extraction|||percentage of volume change||Standard Deviation|Mean
663935|NCT01794741|Primary|Adverse Events Report|reports of treatment emergent adverse events|3 months of treatment|||event|||Number
663936|NCT01794455|Secondary|MRI Arterial Spin Labeling|MRI arterial spin labeling is a noninvasive approach to measuring cerebral blood flow. This relates to the Phase 2 candesartan arm.|Change from week 8 to week 20|MRI data could not be obtained on the one study participant due to MRI contraindications.|||||
663937|NCT01794455|Secondary|Montgomery-Asberg Depression Rating Scale|MADRS is a measure of depression severity (range 0 - 60, higher scores indicate more severe depressive symptoms). This outcome applies to the candesartan Phase 2 arm.|Week 20|||units on a scale|||Number
663938|NCT01794455|Secondary|Quick Inventory of Depressive Symptoms, Self-Rated (QIDS-SR16)|Self-report measure of depression severity (range 0 - 27, higher scores indicate more severe depressive symptoms). This applies to the candesartan Phase 2 arm.|Week 20|||units on a scale|||Number
663939|NCT01794455|Secondary|Quick Inventory of Depressive Symptoms, Self-Rated (QIDS-SR16)|Self-report measure of depression severity. This applies to the sertraline Phase 1 arm.|Week 8||||||
663940|NCT01794455|Primary|Montgomery Asberg Depression Rating Scale (MADRS)|MADRS is a measure of depression severity. This outcome applies to the sertraline Phase 1 arm.|Week 8||||||
663941|NCT01794455|Primary|MRI Arterial Spin Labeling|MRI arterial spin labeling is a noninvasive approach to measuring cerebral blood flow. This relates to the Phase 1 sertraline arm.|Change in perfusion from baseline to week 8|Could not complete MRI.|||||
663942|NCT01794000|Secondary|Percentage of Participants With Hemorrhagic Events Requiring Medical Intervention|Medical intervention was defined as any medical evaluation resulting in therapy or further investigation, as determined by a trained medical professional. Data collected from the first dose of study medication through 10 days after last dose of study medication during the double blind study period are presented below.|First Dose through 24 Months|All randomized participants who received at least one dose of drug.||Percentage of Participants|||Number
663943|NCT01794000|Secondary|Time From Randomization to First and Second VOC|Data collected through the primary completion date are presented below.|Randomization to First VOC and Second VOC respectively (up to 24 Months)|All randomized participants.||Days||95% Confidence Interval|Median
663944|NCT01794000|Secondary|Number of Days Hospitalized for VOC|The total length of hospitalization in days for VOC was calculated for each participant. Data collected through the primary completion date are presented below.|Randomization through 24 Months|All randomized participants who were hospitalized for VOC.||Days||Standard Error|Least Squares Mean
663946|NCT01794000|Secondary|Quarterly Rate of School Absence Due to Sickle Cell Pain|Quarterly rate of school absence due to sickle cell pain was measured through participant diaries and was calculated for each participant by summing the number of days with school absence due to sickle cell pain divided by the number of school dates in the quarter. A quarter was defined as 12 weeks. The quarterly rate was set to missing if there were more than 6 weeks of missing diary entries during a specific quarter. Data collected through the primary completion date are presented below.|Randomization through 9 Months|All Randomized participants who are 4 years or older and have both baseline and at least one post-baseline quarterly outcome measure in any quarter. Diaries were only provided to participants 4 years and older.||Percentage of Days in a Quarter||Standard Error|Least Squares Mean
663947|NCT01794000|Secondary|Monthly Rate of Days of Analgesic Use|Monthly rate of days of analgesic use was measured through participant diaries and was calculated for each participant by summing the number of days they reported analgesic use divided by the number of diary entries completed in the month. A month was defined as 4 weeks (28 days). The monthly rate was set to missing if there were more than 14 missing entries for analgesic use in a specific month. Data collected through the primary completion date are presented below.|Randomization through 9 Months|All randomized participants who are 4 years or older and have baseline and at least one post-baseline monthly outcome measure in any month. Diaries were only provided to participants 4 years and older.||Percentage of Days in a Month||Standard Error|Least Squares Mean
663948|NCT01794000|Secondary|Number of Red Blood Cell (RBC) Transfusions Due to Sickle Cell Disease (SCD) Per Participant Per Year (Rate of RBC Transfusions)|RBC transfusions that occurred within 7 days of the prior event onset date were not counted as a new episode. Data collected through the primary completion date are presented below.|Randomization through 24 Months|All randomized participants.||Number of Events per Participant-Year|||Number
663949|NCT01794000|Secondary|Number of Acute Chest Syndrome Per Participant Per Year (Rate of Acute Chest Syndrome)|Acute chest syndrome was defined as an acute illness characterized by fever and/or respiratory symptoms, accompanied by a new pulmonary infiltrate on a chest X-ray. Acute chest syndrome that occurred within 7 days of the prior event onset date was not counted as a new episode. Data collected through the primary completion date are presented below.|Randomization through 24 Months|All randomized participants.||Number of Events per Participant-Year|||Number
663950|NCT01794000|Secondary|Number of Hospitalizations for VOC Per Participant Per Year (Rate of Hospitalizations)|Hospitalization that occurred within 7 days of the prior event onset date were not counted as a new episode. Data collected through the primary completion date are presented below.|Randomization through 24 Months|All randomized participants.||Number of Events per Participant-Year|||Number
663951|NCT01794000|Secondary|Number of Painful Crisis Events Per Participant Per Year (Rate of Painful Crisis)|A painful crisis is defined as an onset of moderate to severe pain that lasts at least 2 hours for which there is no explanation other than vaso-occlusion and which requires therapy with oral or parenteral opioids, ketorolac, or other analgesics prescribed by a health care provider (HCP) in a medical setting such as a hospital, clinic, emergency room visit, or telephone management. The painful crisis that occurred within 7 days from the prior event onset date was not counted as a new episode. Data collected through the primary completion date are presented below.|Randomization through 24 Months|All randomized participants.||Number of Events per Participant-Year|||Number
663952|NCT01794000|Secondary|Monthly Mean in Faces Pain Scale-Revised Score|Each day participants selected the face on the FPS-R scale that reflected their worst pain related to sickle cell disease (SCD) on that day. Monthly mean in FPS-R score was calculated for each participant by summing the FPS-R score divided by the number of non-missing diary entries completed in the month. This pain scale contains six faces corresponding to the pain intensity of 0, 2, 4, 6, 8 or 10, in which 0 denotes no pain and 10 denotes the worst pain possible. A month was defined as 4 weeks (28 days). The monthly mean in FPS-R score was set to missing if there were more than 14 missing entries for the FPS-R in a specific month. Data collected through the primary completion date are presented below.|Randomization through 9 Months|All randomized participants who are 7 years or older and have both baseline and at least one post-baseline monthly outcome measure in any month. This is the Sickle cell population in which content validity has been established for the FPS-R.||Units on a Scale||Standard Error|Least Squares Mean
663953|NCT01794000|Secondary|Monthly Rate of Days With Pain|Monthly rate of days with pain was measured through participant diaries using a modified version of the Faces Pain Scale-Revised (FPS-R). Each day participants selected the face on the scale that reflected their worst pain related to sickle cell disease (SCD) on that day. This pain scale contains six faces corresponding to the pain intensity of 0, 2, 4, 6, 8 or 10, in which 0 denotes no pain and 10 denotes the worst pain possible. Any day the participant selected a face other than face 0 was considered a day with pain. Monthly rate of days with pain was calculated for each participant by summing the number of days reported with any pain divided by the number of non-missing diary entries completed in the month. A month was defined as 4 weeks (28 days).The monthly rate was set to missing if there were more than 14 missing entries for the FPS-R in a specific month. Data collected through the primary completion date are present below.|Randomization through 9 Months|All randomized participants who are 7 years or older and have both baseline and at least one post-baseline monthly outcome measure in any month. This is the Sickle cell population in which content validity has been established for the FPS-R.||Percentage of Days in a Month||Standard Error|Least Squares Mean
663954|NCT01794000|Primary|Number of Vaso-Occlusive Crisis (VOC) Events Per Participant Per Year (Rate of VOC)|The VOC is a composite endpoint of painful crisis or acute chest syndrome. Events that occurred within 7 days from the prior event onset date were not counted as a new episode. Data collected through the primary completion date reported below.|Randomization through 24 Months|All randomized participants.||Number of Events per Participant-Year|||Number
663955|NCT01793883|Primary|Time to Alleviation of Influenza Symptoms|Time to alleviation of influenza will be assessed through Flu-iiQ (Influenza intensity and impact Questionnaire) and diary cards from Day 1 to 14.|Efficacy will be assessed over 14 days post-randomization.|Intent-to-treat-infected (ITT-I) population - all ITT subjects with laboratory confirmed influenza A or B infection by at least one virological method (qRT-PCR or qCulture) on either Day 1 or 3||hours||95% Confidence Interval|Median
664000|NCT01792635|Primary|Whole-body Glucose Uptake in Part A|Whole-body glucose uptake (Rate of glucose disappearance, Rd) during the Step 2 Clamp|1 day|All participants randomized and who had at least one euglycemic hyperinsulinemic clamp.||mg/kg BW/min||90% Confidence Interval|Mean
663956|NCT01793688|Secondary|Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert|A treatment-related adverse event was any untoward medical occurrence attributed to sulbactam sodium/ampicillin sodium in a participant who received sulbactam sodium/ampicillin sodium. Expectedness of the adverse event was determined according to Japanese package insert. Relatedness to sulbactam sodium/ampicillin sodium was assessed by the investigator.|14 Days|The safety analysis set comprised of participants who satisfied the inclusion criteria of the study, and who had been received sulbactam sodium/ampicillin sodium at least once.||Participants|||Number
663957|NCT01793688|Secondary|Number of Participants With Treatment-Related Serious Adverse Events|A treatment-related adverse event was any untoward medical occurrence attributed to sulbactam sodium/ampicillin sodium in a participant who received sulbactam sodium/ampicillin sodium. A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to sulbactam sodium/ampicillin sodium was assessed by the investigator.|14 Days|The safety analysis set comprised of participants who satisfied the inclusion criteria of the study, and who had been received sulbactam sodium/ampicillin sodium at least once.||Participants|||Number
663958|NCT01793688|Primary|Clinical Effectiveness Rate by Indication|Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of participants with assessable effectiveness evaluation, was presented by each indication (pneumonia, lung abcess and peritorinitis) along with the corresponding exact 2-sided 95% confidence interval. Overall effectiveness of sulbactam sodium/ampicillin sodium was determined by the investigator based on clinical symptoms and examinations at the end of high-dose (>6 g daily) treatment. Clinical effectiveness was assessed according to the following categories: (1) effective, (2) ineffective, or (3) unassessable at the end of treatment.|14 Days|The effectiveness analysis set comprised of participants in safety analysis set who had effectiveness evaluation at least once.||Percentage of participants||95% Confidence Interval|Number
663959|NCT01793688|Primary|Number of Participants With Treatment-Related Adverse Events|A treatment-related adverse event was any untoward medical occurrence attributed to sulbactam sodium/ampicillin sodium in a participant who received sulbactam sodium/ampicillin sodium. Relatedness to sulbactam sodium/ampicillin sodium was assessed by the investigator.|14 Days|The safety analysis set comprised of participants who satisfied the inclusion criteria of the study, and who had been received sulbactam sodium/ampicillin sodium at least once.||Participants|||Number
663960|NCT01793285|Secondary|Time to Treatment Discontinuation With Etanercept|Time to treatment discontinuation with etanercept was assessed retrospectively at Year 3 for participants who did not discontinue treatment at the end of previous LoadET study 0881A3-102090 (NCT00873730). It was defined as time from first dose of etanercept received in the previous LoadET study 0881A3-102090 (NCT00873730) to last dose of etanercept.|Year 3|Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure.||years||95% Confidence Interval|Mean
663961|NCT01793285|Secondary|Lipid Profile: Total Cholesterol (TC), High Density Lipoprotein (HDL) and Triglycerides Levels|Lipid profile included following parameters: Total Cholesterol (TC), high-density lipoprotein (HDL) and triglycerides (TGs).|Baseline, Year 1, 2, 3|Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for each parameter at specified time point.||milligram per deciliter (mg/dL)||Inter-Quartile Range|Median
663962|NCT01793285|Secondary|Erythrocyte Sedimentation Rate (ESR)|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeter/hour (mm/hr). A higher rate is consistent with inflammation.|Baseline, Year 1, 2, 3|Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.||mm/hr||Inter-Quartile Range|Median
663963|NCT01793285|Secondary|C-reactive Protein (CRP)|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Year 1, 2, 3|Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.||milligram per milliliter (mg/mL)||Inter-Quartile Range|Median
663964|NCT01793285|Secondary|Chest Expansion Measurement|Chest expansion, measured in cm (rounded to the nearest 0.1 cm), is defined as the difference in thoracic circumference during full expiration versus full inspiration, measured at the fourth intercostal space (nipple line). Chest expansion was measured for both maximum and minimum inhalation. The measurement of two attempts was made.|Baseline, Year 1, 2, 3|Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.||cm||Inter-Quartile Range|Median
663965|NCT01793285|Secondary|Occiput-to-wall Distance|Occiput-to-wall distance: distance between the occiput (posterior or back portion of the head) and the wall when the participant stood with heels and shoulder against the wall and the back straight. The distance between the occiput and the wall was measured in cm (rounded to the nearest 0.1 cm), in two attempts.|Baseline, Year 1, 2, 3|Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.||cm||Inter-Quartile Range|Median
666040|NCT01763905|Secondary|Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
663966|NCT01793285|Secondary|Modified Schober's Test|Measurement in centimeters (cm) of the distance between marks originally placed while the participant was standing erect 10 cm above and 5 cm below the midpoint of a line that joints the posterior superior iliac spines. Distance between marks was re-measured (in cm rounded to the nearest 0.1 cm) with participant maximally bend forward, knees fully extended, with spine in full flexion. The measurement of two attempts was made.|Baseline, Year 1, 2, 3|Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.||cm||Inter-Quartile Range|Median
663967|NCT01793285|Secondary|Fatigue as Assessed Using Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)|Participant’s fatigue was assessed by answering question 1 of BASDAI on a 0 to 10 VAS; participants were asked: “How would you describe the overall level of fatigue/tiredness you have experienced?” 0=none and 10=very severe.|Baseline, Year 1, 2, 3|Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.||units on a scale||Inter-Quartile Range|Median
663968|NCT01793285|Secondary|Spinal Pain as Assessed Using Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)|Participant’s spinal pain - was assessed by answering question 2 of BASDAI on a 0 to10 VAS; participants were asked: “How would you describe the overall level of ankylosing spondylitis neck, back or hip pain you have had?” 0 =none and 10 =very severe.|Baseline, Year 1, 2, 3|Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.||units on a scale||Inter-Quartile Range|Median
663969|NCT01793285|Secondary|Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)|BASDAI is a validated self-assessment tool used to determine disease activity in participant with ankylosing spondylitis. Utilizing a VAS of 0-10, 0=none and 10=very severe participant's answered 6 questions measuring discomfort, pain and fatigue. The final BASDAI score is a sum of the individual assessments. Final score ranged from 0-60, higher score indicates higher disease activity.|Baseline, Year 1, 2, 3|Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.||units on a scale||Inter-Quartile Range|Median
663970|NCT01793285|Secondary|Bath Ankylosing Spondylitis Functional Index (BASFI)|BASFI is a validated self-assessment tool that determines the degree of functional limitation in ankylosing spondylitis. Utilizing a VAS of 0-10, 0 = easy, 10 = impossible, participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a sum of the scores of the 10 questions, final score ranged from 0-100, where higher score referred to higher impairment in the functional ability.|Baseline, Year 1, 2, 3|Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.||units on a scale||Inter-Quartile Range|Median
663971|NCT01793285|Secondary|Patient Global Assessment (PtGA) of Disease Activity Score|Participants disease activity assessed using a 100 millimeter (mm) Visual Analog Scale (VAS), ranging from 0 = very good to 100 = very bad.|Baseline, Year 1, 2, 3|Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.||mm||Inter-Quartile Range|Median
663972|NCT01793285|Secondary|Number of Participants Who Received Pharmacological Treatment|Participants who received any pharmacological treatment (non-steroidal anti-inflammatory drugs [NSAIDs], disease-modifying antirheumatic drugs [DMARDs], corticosteroids and other treatments including anti-tumor necrosis factor-alpha [TNFalpha] or other biological agents etc.) in the 3 years since the last LoadET study 0881A3-102090 (NCT00873730) visit were reported.|Baseline up to Year 3|Analysis population included all participants who had previously participated in the LoadET study (NCT00873730) and fulfilled all the eligibility criteria.||participants|||Number
663973|NCT01793285|Secondary|Number of Participants Who Received Non-pharmacological Treatment|Participants who received any non-pharmacological treatment (participant education, regular exercises and physical therapy) in the 3 years since the last LoadET study 0881A3-102090 (NCT00873730) visit were reported.|Baseline up to Year 3|Analysis population included all participants who had previously participated in the LoadET study (NCT00873730) and fulfilled all the eligibility criteria.||participants|||Number
663974|NCT01793285|Secondary|Time to Diagnosis of Ankylosing Spondylitis|Time to first diagnosis of alkylosing spondylitis was reported.|Baseline|Analysis population included all participants who had previously participated in the LoadET study (NCT00873730) and fulfilled all the eligibility criteria.||years||Standard Deviation|Mean
663975|NCT01793285|Secondary|Time Between the Onset of Ankylosing Spondylitis Symptoms and First Visit to the Rheumatologist|Time passed since the ankylosing spondylitis symptoms started until the participant arrived for the first time to visit the rheumatologist was reported. Ankylosing spondylitis symptoms may include pain, stiffness, axial manifestations, and enthesitis etc.|Baseline|Analysis population included all participants who had previously participated in the LoadET study (NCT00873730) and fulfilled all the eligibility criteria.||years||Standard Deviation|Mean
663976|NCT01793285|Primary|Percentage of Participants Who Discontinued Treatment With Etanercept|Participants who discontinued etanercept following 3 years after finalization of LoadET study 0881A3-102090 (NCT00873730) due to any of these reason were reported: adverse events, failure in therapeutic response, disease remission and discontinued for other causes.|Baseline up to Year 3|Analysis population included all participants who had previously participated in the LoadET study (NCT00873730) and fulfilled all the eligibility criteria.||percentage of participants|||Number
663977|NCT01792986|Secondary|Difference in Red Blood Cell Count Between Baseline and the End of the Sixth Week.||6 weeks|||trillion cells/L||Standard Deviation|Mean
663987|NCT01792830|Primary|Efficacy, Measured by a Change in HbA1c Levels|Change in the level of HbA1c in a 1 month period after discharge from the hospital. The A1c test result is reported as a percentage. Higher percentages indicate higher blood glucose levels in the previous three months. A normal HbA1c level is below 5.7 percent.|Hospital discharge, 1 month|Most patients that completed the discharge part did so over the phone. Some of the subjects who came to the hospital for their visit had trouble getting their blood drawn for HbA1c levels.||percent of glycosylated hemoglobin||Standard Deviation|Mean
663988|NCT01792635|Secondary|Ra in Part B in PF-05175157 200 mg BID Group|Ra in fasting state and during insulin infusions (Step 1 and Step 2).|6 weeks|Part B of the study was terminated due to the safety issue. Due to the limited participant number who completed study there no summary statistics were done by dosing regimen for Part B.||mg/kg BW/min||Full Range|Mean
663989|NCT01792635|Secondary|Ra in Part B in Placebo Group|Ra in fasting state and during insulin infusions (Step 1 and Step 2).|6 weeks|Part B of the study was terminated due to the safety issue. Due to the limited participant number who completed study there no summary statistics were done by dosing regimen for Part B.||mg/kg BW/min||Full Range|Mean
663990|NCT01792635|Secondary|EGP in Part B in PF-05175157 200 mg BID Group|EGP measured by means of euglycemic hyperinsulinemic clamp preceding insulin infusion (EGP0), on Step 1 insulin infusion (EGP1) and on Step 2 insulin infusion (EGP2)|6 weeks|Part B of the study was terminated due to the safety issue. Due to the limited participant number who completed study there no summary statistics were done by dosing regimen for Part B.||mg/kg fat free mass (FFM)/min||Full Range|Median
663991|NCT01792635|Secondary|EGP in Part B in Placebo Group|EGP measured by means of euglycemic hyperinsulinemic clamp preceding insulin infusion (EGP0), on Step 1 insulin infusion (EGP1) and on Step 2 insulin infusion (EGP2)|6 weeks|Part B of the study was terminated due to the safety issue. Due to the limited participant number who completed study there no summary statistics were done by dosing regimen for Part B.||mg/kg fat free mass (FFM)/min||Full Range|Median
663992|NCT01792635|Secondary|GIR in Part B in PF-05175157 200 mg BID Group|Glucose Infusion Rate rates obtained averaging respectively the last 30 minutes of glucose infusion at steady state on Step 1 (ie 150 to 180 min) and Step 2 (ie 330 to 360 min) insulin infusion.|6 weeks|Part B of the study was terminated due to the safety issue. Due to the limited participant number who completed study there no summary statistics were done by dosing regimen for Part B.||mg/min||Full Range|Mean
663993|NCT01792635|Secondary|GIR in Part B in Placebo Group|Glucose Infusion Rate rates obtained averaging respectively the last 30 minutes of glucose infusion at steady state on Step 1 (ie 150 to 180 min) and Step 2 (ie 330 to 360 min) insulin infusion.|6 weeks|Part B of the study was terminated due to the safety issue. Due to the limited participant number who completed study there no summary statistics were done by dosing regimen for Part B.||mg/min||Full Range|Mean
663994|NCT01792635|Primary|Number of Participants With Change From Baseline and Absolute Values in Electrocardiogram (ECG) Meeting Categorical Summarisation Criteria in Part B|Criteria for PCI changes in ECG (12-lead) were defined as: the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization (PR interval) >=300 milliseconds (msec) and increase of >=25% from baseline when baseline >200 msec or increase of >=50% when baseline less than or equal to (<=) 200 msec; the time from the beginning of the electrocardiogram Q wave to the end of the S wave corresponding to ventricular depolarization (QRS interval) >=140 msec and increase of >=50% from baseline; the time corresponding to the beginning of depolarization to repolarization of the ventricles (QT), corrected for heart rate (QTc) using the Fridericia formula (QTcF) of 450 to < 480 msec and >=480 msec, or an increase from baseline of 30 to <60 msec or >=60 msec.|Screening up to follow-up (up to approximately 10 to 14 days after the last study drug administration)|All participants who were admitted to the CRU on Day -5.||Participants|||Number
663995|NCT01792635|Primary|Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria in Part B|Criteria for potentially clinical important (PCI) change in vital signs included: sitting systolic blood pressure (SBP) of less than (<) 90 millimeters of mercury (mm Hg) or change in sitting SBP of greater or equal to (>=)30 mm Hg, sitting diastolic blood pressure (DBP) of <50 mm Hg or change in sitting DBP of >=20 mm Hg, sitting pulse rate of <40 or greater than (>) 120 beats per minute (bpm).|Screening up to follow-up (up to approximately 10 to 14 days after the last study drug administration)|All participants who were admitted to the CRU on Day -5||Participants|||Number
663996|NCT01792635|Primary|Number of Participants With Laboratory Test Abnormalities in Part B|Number of participants with laboratory test abnormalities without regard to baseline abnormality. The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell [RBC] count, platelet count, white blood cell [WBC] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen [BUN], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, alkaline phosphatase, uric acid, albumin, total protein, and creatine phosphokinase); urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, and microscopy); others (follicle stimulating hormone [FSH], urine drug screen, lipid profile and very-low-density lipoproteins [VLDL], hemoglobin A1c [HbA1c], C-peptide, thyroid-stimulating hormone [TSH], Hepatitis B and C, human immunodeficiency virus [HIV], triglycerides, urine creatinine).|Screening up to follow-up (up to approximately 10 to 14 days after the last study drug administration)|All participants who were admitted to the Clinical Research Unit (CRU) on Day -5||Participants|||Number
663997|NCT01792635|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs), or Discontinuation Due to Adverse Events (AEs) in Part B|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline to follow-up (up to approximately 10 to 14 days after the last study drug administration)|All participants who were admitted to the clinical research unit (CRU) on Day -5||Participants|||Number
663998|NCT01792635|Primary|Whole-body Glucose Uptake in Part B in PF-05175157 200 mg BID Group|Whole-body glucose uptake (Rate of glucose disappearance, Rd) during the Step 2 Clamp|6 weeks|Part B of the study was terminated due to the safety issue. Due to the limited participant number who completed study there no summary statistics were done by dosing regimen for Part B.||mg/kg BW/min||Full Range|Mean
664002|NCT01792635|Primary|[6,6-2H2] Plasma Glucose Enrichment (PGE) in Part A|[6,6-2H2] PGE was the molar fraction of labeled glucose measured in plasma. Whole-body insulin sensitivity was assessed with the euglycemic hyperinsulinemic clamp procedure; the use of 2 stepped insulin infusions and labeled glucose allowed the differentiation between hepatic and peripheral insulin sensitivity.|1 day|All participants randomized and who had at least one euglycemic hyperinsulinemic clamp||percentage enrichment of plasma glucose||90% Confidence Interval|Mean
664003|NCT01792635|Primary|Endogenous Gucose Production (EGP) in Part A|EGP measured by means of euglycemic hyperinsulinemic clamp preceding insulin infusion (EGP0), on Step 1 insulin infusion (EGP1) and on Step 2 insulin infusion (EGP2). Whole-body insulin sensitivity was assessed with the euglycemic hyperinsulinemic clamp procedure; the use of 2 stepped insulin infusions and labeled glucose allowed the differentiation between hepatic and peripheral insulin sensitivity. EGP was measured under basal conditions; then during the low dose insulin infusion EGP was partially suppressed (hepatic insulin sensitivity), while during the high dose insulin infusion, EGP was almost completely suppressed and peripheral glucose uptake was maximally stimulated (peripheral insulin sensitivity).|1 day|All participants randomized and who had at least one euglycemic hyperinsulinemic clamp||mg/kilogram (kg) body weight (BW)/min||Full Range|Median
664004|NCT01792635|Primary|Glucose Infusion Rates (GIR) in Part A|GIR obtained averaging respectively the last 30 minutes of glucose infusion at steady state on Step 1 (ie 150 to 180 min) and Step 2 (ie 330 to 360 min) insulin infusion. Whole-body insulin sensitivity was assessed with the euglycemic hyperinsulinemic clamp procedure; the use of 2 stepped insulin infusions and labeled glucose allowed the differentiation between hepatic and peripheral insulin sensitivity. Assessment of whole body insulin sensitivity was performed during the steady states of the low insulin infusion rate (ie, Step 1) and during the steady state of the high insulin infusion rate (ie, Step 2). These indices were called GIR1 and GIR2, respectively.|1 day|All participants randomized and who had at least one euglycemic hyperinsulinemic clamp||mg/min||90% Confidence Interval|Mean
664005|NCT01792518|Secondary|The Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) After 24 Weeks of Treatment|The change from baseline in estimated glomerular filtration rate (eGFR) as assessed by chronic kidney disease epidemiology collaboration (CKD-EPI) equation (cystatin C) after 24 weeks of treatment. The term “baseline” refers to the last observation before the start of any randomised trial treatment. The number of participants analysed displays the number of participants with available data at the timepoint of interest. This outcome measure is a secondary safety endpoint.|Baseline and 24 weeks|Treated Set||milliliter/minute/1.73 square metre||Standard Error|Least Squares Mean
664006|NCT01792518|Secondary|The Time Weighted Average of Percentage Change From Baseline in UACR During the Course of 24 Weeks of Treatment|"The time weighted average of percentage change from baseline in UACR (mg/g creatinine) during the course of 24 weeks of treatment. The term baseline for UACR refers to the geometric mean of UACR values measured at Visits 2 and 3. The number of participants analysed displays the number of participants with available data at the timepoint of interest. The Least Squares Means are adjusted geometric means."|Baseline and 24 weeks|Full Analysis Set (FAS) - including all randomised patients who were treated with at least one dose of study drug, had a baseline HbA1c and a baseline Urinary albumin creatinine ratio (UACR), and at least one on treatment HbA1c or UACR assessment. Last Observation Carried Forward (LOCF).||mg/g creatinine||95% Confidence Interval|Least Squares Mean
664007|NCT01792518|Primary|HbA1c Change From Baseline After 24 Weeks Double-blind Randomized Treatment|Change from baseline in Glycated haemoglobin (HbA1c) [%] after 24 weeks of treatment with double- blind trial medication. The term “baseline” refers to the last observation before the start of any randomised trial treatment. The number of participants analysed displays the number of participants with available data at the timepoint of interest.|Baseline and 24 weeks|Full Analysis Set (FAS) - including all randomised patients who were treated with at least one dose of study drug, had a baseline HbA1c and a baseline Urinary albumin creatinine ratio (UACR), and at least one on treatment HbA1c or UACR assessment. Observed Case (OC): Values after the use of rescue medication were set to missing.||Percentage of HbA1c||Standard Error|Least Squares Mean
664008|NCT01791972|Secondary|Participants Whose Maximum Percentage Decrease From the Baseline Forced Expiratory Volume in 1 Second (FEV1) Post-Exercise Challenge Was >20%|Participants were classified as unprotected if the maximum percentage decrease from baseline FEV1 after exercise was more than 20%. Data represents the number of participants who were classified as unprotected.|Days 1 and 7; up to 60 minutes post-exercise challenge|Full analysis set||participants|||Number
664009|NCT01791972|Secondary|Percentage of Participants Whose Maximum Percentage Decrease From the Baseline Forced Expiratory Volume in 1 Second (FEV1) Post-Exercise Challenge Was <10%|Participants were classified as protected if the maximum percentage decrease from baseline FEV1 after exercise was less than 10%. Data represents the percentage of participants who were classified as protected.|Days 1 and 7; up to 60 minutes post-exercise challenge|Full analysis set||percentage of participants|||Number
664010|NCT01791972|Primary|Maximum Percentage Fall From Baseline in Forced Expiratory Volume in 1 Second (FEV1) up to 60 Minutes After the Exercise Challenge|"A centralized spirometry data collection system was used to reduce FEV1 variability between and within patients and between each participating study center.
The percentage fall was defined as 100*(baseline-post baseline)/baseline. The baseline FEV1 is the test day FEV1 measured 5 minutes before the exercise challenge (30 minutes postdose). FEV1 post exercise challenge were measured 5 (±5), 10 (±5), 15 (±5), 30 (±5), and 60 (±10) minutes after completion of the exercise challenge.
The exercise challenge consisted of the participant running on a motor-driven treadmill (with adjustable speed and incline). The treadmill was set at a speed and incline sufficient to increase the participant’s heart rate to ≥80% of the maximum rate for age (220 bpm–age in years) for a period of either 6, 7, or 8 minutes using a stepped-exercise protocol in accordance with ATS guidelines (American Thoracic Society 2000). Conditions were repeated for subsequent challenges."|Days 1 and 7; up to 60 minutes post-exercise challenge|Full analysis set||percentage change from baseline FEV1||Standard Error|Mean
664011|NCT01791894|Secondary|Incidence of Grade 3/4 Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0||Baseline to cycle 3|||number of occurrences|||Number
664012|NCT01791894|Secondary|Patients With Progressive Disease Post Treatment by RECIST Criteria|Patients with a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|After 3 treatment cycles (approx. 61 days)|||participants|||Number
664015|NCT01791803|Secondary|Smoking Abstinence Rate at 12 and 26 Weeks|Abstinence rates were calculated for patients hospitalized with a cardiac or a pulmonary diagnosis.|12 weeks and 26 weeks after hospital discharge|Abstinence comparing the 2 admitting diagnoses was similar within each arm, thus analysis for admitting diagnosis was done combining the 4 arms.||percentage of smoking abstinence rate|||Number
664016|NCT01791803|Secondary|Smoking Cessation|Abstinence from smoking at 12 weeks after hospitalization was measured by self reported 7-day prevalence and verified urinary Cotinine test. This included participants in groups receiving hypnotherapy, NRT or both. Self quit group was not approached until 26 weeks after discharge. Patients lost to follow up were considered smokers.|at 12 weeks after hospitalization|||Participants|||Count of Participants
664017|NCT01791803|Primary|Abstinence From Smoking|Assessed by 7-day prevalence of verified tobacco abstinence at 26 weeks after hospitalization for a cardiopulmoanry illness. Verification was confirmed biochemically by urine Cotinine testing or by telephone and discussion with a household proxy. Patients lost to follow up were considered to be persistent smokers.|at 26 weeks after hospitalization|||percentage of participants|||Number
664018|NCT01791725|Other Pre-specified|Improvement in NPI Total Scores in Subjects With NPI Score ≥1 at Baseline Baseline|The Neuropsychiatric Inventory(NPI) (Cummings et al 1994) is a behavioral measure that assesses psychopathology in dementia patients. The NPI was administered at the Baseline Visit (Day 1) and at Day 28 (EOS) or ET. A decrease in score shows an improvement in symptoms.|Baseline and 4 weeks|Subjects with NPI Score ≥1 at baseline||participants|||Number
664019|NCT01791725|Other Pre-specified|Cognitive Outcome (RADD Total Score)|Rapid Assessment for Development Disabilities (RADD) The RADD test was developed from the low-difficulty items from published intelligence tests (Walsh et al 2007). It was specifically developed for evaluation of individuals with intellectual disabilities and developmental disabilities. It is a validated and reliable cognitive screening instrument that can be rapidly administered. The RADD is composed of 76 items. Each item is scored as 0 (incorrect) or 1 (correct).The test assesses a wide range of functional abilities including receptive and expressive language, orientation, registration, recall, attention, self identification, motor skills, imitation, abstract reasoning, number skills, comprehension and short-term memory to give a total score. Scores are from 0 to 76. A higher total score is correlated with a higher Cognitive Impairment level.|Baseline and 4 Weeks|||units on a scale||Standard Deviation|Mean
664020|NCT01791725|Other Pre-specified|Pharmacokinetic Assessment|Mean Plasma ELND005 Concentrations- Cmax|Baseline and 4 Weeks|||μg/mL||Standard Deviation|Mean
664021|NCT01791725|Other Pre-specified|Changes From Baseline in Abnormal Neurological Examination Results|Subjects with Abnormal Neurological Examination Results|Baseline and 4 weeks|||participants|||Number
664022|NCT01791725|Primary|Incidence of Adverse Events (TEAEs)|For all AE summaries, if a patient had more than one AE within a preferred term, the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a SOC, the subject was similarly counted only once when reporting results for that SOC.|4 weeks|||participants|||Number
664023|NCT01791491|Secondary|Percentage of CD86 Receptor Occupancy|Blood samples collected following the single dose belatacept infusion were assessed for CD86 receptor occupancy (CD86 RO).|0.5 hours post dose on Day 1, Day 29 and Day 57|Pharmacodynamic analysis set: all participants who received one dose of belatacept and who had at least 1 pharmacodynamic result (CD86 RO) reported after that dose.||percent||Standard Deviation|Mean
664024|NCT01791491|Secondary|Number of Participants With Positive Belatacept-induced Immunogenicity Response|Serum samples were analyzed for anti-belatacept antibodies using a validated homogenous bridging assay. The assay followed a tiered approach consistent with health authority guidance: tier 1 for screening ADA responses, tier 2 for confirming drug specificity of the ADA-positive responses, and tier 3 for titer. A neutralizing antibody assay was used to test those samples positive to the LEA29Y portion of the molecule in tier 2 and for which drug concentrations are =>1 μg/mL. Lack of immunogenicity was defined as the absence of a positive response.|Baseline/Day 1, Days 15, 29, and 57|All treated participants who received at least one dose of belatacept.||participants|||Number
664025|NCT01791491|Primary|Volume of Distribution at Steady-state (Vss) of Belatacept|"Vss was derived from serum concentration versus time data. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: pre-dose (0 hours), 0.5 and 2 hours from Start of Infusion on Day 1, Day 29, and Day 57. The results were summarized. The lower limit of assay quantitation (LLOQ) was set to zero which was 0.003 micrograms per milliliter (ug/mL). Vss was measured in liters per kg body weight (L/kg)."|Pre-dose (0), 0.5hr and 2hr from the start of infusion on Day 1, Day 29, and Day 57|Pharmacokinetic (PK) analysis set: all participants who received one dose of belatacept and who had at least 1 blood sample drawn for PK determination.||Liters per kilogram||Geometric Coefficient of Variation|Geometric Mean
664026|NCT01791491|Primary|Total Body Clearance (CLT) of Belatacept|"CLT was the volume of abatacept cleared by the system, normalized by baseline body weight. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: pre-dose (0 hours), 0.5 and 2 hours from Start of Infusion on Day 1, Day 29, and Day 57. The results were summarized. The lower limit of assay quantitation (LLOQ) was set to zero which was 0.003 micrograms per milliliter (ug/mL). CLT was measured in milliliters per hours per kilogram of body weight (mL/h/kg)."|Pre-dose (0), 0.5hr and 2hr from the start of infusion on Day 1, Day 29, and Day 57|Pharmacokinetic (PK) analysis set: all participants who received one dose of belatacept and who had at least 1 blood sample drawn for PK determination.||milliliters per hours per kilogram||Geometric Coefficient of Variation|Geometric Mean
664027|NCT01791491|Primary|Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC (0-T)) and Area Under the Serum Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) of Belatacept|"AUC (0 - T) and AUC (0 - INF) were derived from serum concentration versus time data and measured in microgram hours per milliliter (µg*h/mL). Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: pre-dose (0 hours), 0.5 and 2 hours from Start of Infusion on Day 1, Day 29, and Day 57. The results were summarized. The lower limit of assay quantitation (LLOQ) was set to zero which was 0.003 micrograms per milliliter (ug/mL)."|Pre-dose (0), 0.5hr and 2hr from the start of infusion on Day 1, Day 29, and Day 57|Pharmacokinetic (PK) analysis set: all participants who received one dose of belatacept and who had at least 1 blood sample drawn for PK determination.||microgram hours per milliliter||Geometric Coefficient of Variation|Geometric Mean
664028|NCT01791491|Primary|Half-Life of Elimination (T-Half) of Belatacept|"T-HALF was derived from serum concentration versus time data. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: pre-dose (0 hours), 0.5 and 2 hours from Start of Infusion on Day 1, Day 29, and Day 57. The results were summarized. The lower limit of assay quantitation (LLOQ) was set to zero which was 0.003 micrograms per milliliter (ug/mL). T-HALF was measured in hours (h)."|Pre-dose (0), 0.5hr and 2hr from the start of infusion on Day 1, Day 29, and Day 57|Pharmacokinetic (PK) analysis set: all participants who received one dose of belataceptand who had at least 1 blood sample drawn for PK determination.||hours||Standard Deviation|Mean
664029|NCT01791491|Primary|Time of Maximum Observed Plasma Concentration (Tmax) of Belatacept|"Tmax was derived from serum concentration versus time data. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: pre-dose (0 hours), 0.5 and 2 hours from Start of Infusion on Day 1, Day 29, and Day 57. The results were summarized. The lower limit of assay quantitation (LLOQ) was set to zero which was 0.003 micrograms per milliliter (ug/mL). Tmax was measured in hours (h)."|Pre-dose (0), 0.5hr and 2hr from the start of infusion on Day 1, Day 29, and Day 57|Pharmacokinetic (PK) analysis set: all participants who received one dose of belatacept and who had at least 1 blood sample drawn for PK determination.||hours||Full Range|Median
664030|NCT01791491|Primary|Maximum Observed Serum Concentration (Cmax) of Belatacept|"Cmax was derived from serum concentration versus time data. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: pre-dose (0 hours), 0.5 and 2 hours from Start of Infusion on Day 1, Day 29, and Day 57. The results were summarized. The lower limit of assay quantitation (LLOQ) was set to zero which was 0.003 micrograms per milliliter (ug/mL). Cmax was measured in micrograms per milliliter."|Pre-dose (0), 0.5hr and 2hr from the start of infusion on Day 1, Day 29, and Day 57|Pharmacokinetic (PK) analysis set: all participants who received one dose of belatacept and who had at least 1 blood sample drawn for PK determination.||micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
664031|NCT01791491|Secondary|Number of Participants With Death, Serious Adverse Events (SAEs), and Treatment-related Adverse Event (AE)|Death was a fatal event leading to permanent cessations of all vital functions of the body. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Adverse event (AE) defined: any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Treatment related=having certain, probable, possible, or missing relationship to study drug.|Date of First Dose to 24 weeks post the last dose; approximately 26 weeks|All treated participants who received at least one dose of belatacept.||participants|||Number
664032|NCT01791465|Secondary|Waist to Hip Ratio at Baseline and 16 Weeks||baseline and 16 weeks|||ratio||Inter-Quartile Range|Mean
664033|NCT01791465|Secondary|Hip Circumference at Baseline and 16 Weeks||baseline and 16 weeks|||centimeters||Inter-Quartile Range|Mean
664034|NCT01791465|Secondary|Waist Circumference at Baseline and 16 Weeks||baseline and 16 weeks|||centimeters||Inter-Quartile Range|Mean
664035|NCT01791465|Secondary|Body Weight at Baseline and 16 Weeks||baseline and 16 weeks|||kilograms||Inter-Quartile Range|Mean
664036|NCT01791465|Other Pre-specified|Peripheral Endothelial Tonography, as Measured by the Non-invasive EndoPAT System Using the LnRHI (Natural Log of Reactive Hyperemia Index), at Baseline and 16 Weeks|Normal: LnRHI > 0.51 Abnormal: LnRHI ≤ 0.51|baseline and 16 weeks|||units on a scale||Inter-Quartile Range|Mean
664037|NCT01791465|Secondary|Serum LDL Cholesterol Levels at Baseline and 16 Weeks||baseline and 16 weeks|||mg/dL||Inter-Quartile Range|Mean
664038|NCT01791465|Secondary|Serum HDL Cholesterol Levels at Baseline and 16 Weeks||baseline and 16 weeks|||mg/dL||Inter-Quartile Range|Mean
664039|NCT01791465|Secondary|Serum Total Cholesterol Levels at Baseline and 16 Weeks||baseline and 16 weeks|||mg/dL||Inter-Quartile Range|Mean
664040|NCT01791465|Secondary|Serum Triglycerides Levels at Baseline and 16 Weeks||baseline and 16 weeks|||mg/dL||Inter-Quartile Range|Mean
664041|NCT01791465|Secondary|Serum Hemoglobin A1c (HbA1c) Levels at Baseline and 16 Weeks||baseline and 16 weeks|||percentage of glycated haemoglobin||Inter-Quartile Range|Mean
664042|NCT01791465|Secondary|Serum TNF-a Receptor 2 Levels at Baseline and 16 Weeks||baseline and 16 weeks|||pg/ml||Inter-Quartile Range|Mean
664043|NCT01791465|Secondary|Serum Soluble CD14 Levels at Baseline and 16 Weeks||baseline and 16 weeks|||pg/ml||Inter-Quartile Range|Mean
664044|NCT01791465|Secondary|Serum TNF-a Receptor 1 Levels at Baseline and 16 Weeks||baseline and 16 weeks|||pg/ml||Inter-Quartile Range|Mean
664045|NCT01791465|Secondary|Body Mass Index at Baseline and 16 Weeks||16 weeks|||kg/m2||Inter-Quartile Range|Mean
664046|NCT01791465|Secondary|Serum Adipokine Leptin Levels at Baseline and 16 Weeks||baseline and 16 weeks|||ng/ml||Inter-Quartile Range|Mean
664047|NCT01791465|Secondary|Oral Glucose Insulin Sensitivity (OGIS) at Baseline and 16 Weeks|The Oral Glucose Insulin Sensitivity (OGIS) is a method for the assessment of insulin sensitivity from the oral glucose tolerance test. OGIS provides an index which is analogous to the index of insulin sensitivity obtained from the glucose clamp. OGIS values for glucose clearance are reported in units of ml/min per square meter of body surface area. Lower values indicate slower glucose clearance and higher insulin resistance.|baseline and 16 weeks|||ml/min/m^2 BSA||Inter-Quartile Range|Mean
664048|NCT01791465|Secondary|Serum Macrophage Inflammatory Protein 1 Alpha (MIP-1 Alpha) Levels at Baseline and 16 Weeks||baseline and 16 weeks|||pg/ml||Inter-Quartile Range|Mean
664049|NCT01791465|Secondary|Serum Macrophage Chemotactic Protein-1 (MCP-1) Levels at Baseline and 16 Weeks||baseline and 16 weeks|||pg/ml||Inter-Quartile Range|Mean
664050|NCT01791465|Secondary|Serum Soluble Tumor Necrosis Factor Alpha (TNF-α) Levels at Baseline and 16 Weeks||baseline and 16 weeks|||pg/ml||Inter-Quartile Range|Mean
664051|NCT01791465|Primary|Serum Interleukin 6 (IL-6) at Levels at Baseline and 16 Weeks|The primary outcome will be the change in serum IL-6 levels from baseline (pre-treatment) to 16 weeks of Bydureon treatment.|baseline and 16 weeks|||mg/dl||Inter-Quartile Range|Median
664052|NCT01791465|Primary|Serum Highly-sensitive C-reactive Protein (hsCRP) Levels at Baseline and 16 Weeks|The primary outcome will be the change in hsCRP levels from baseline (pre-treatment) to 16 weeks of Bydureon treatment.|baseline and 16 weeks|Change in hsCRP over 16 weeks of treatment||mg/dl||Inter-Quartile Range|Median
664054|NCT01791244|Secondary|Number of Subjects With Lifestyle Goals for MinSupport Plus at Month 12|Subjects defined up to 4 personal lifestyle goals during the first study week. Subjects completed the following questions related to lifestyle goals achieved during this study: 1. Was the goal achieved? (Yes/No) 2. If yes, better than expected or achieved as expected? 3. If better than expected, a lot or a little better than expected? 4. If no, a little or a lot less than expected?|Month 12|"ITT population included all subjects randomized into the trial and have completed at least 1 post-baseline assessment of the questionnaires. Here, n signifies subjects who were evaluable for the specific goal in this outcome measure."||Subjects|||Number
664055|NCT01791244|Secondary|Number of Subjects With Response Based on Health Care Personnel Satisfaction Questionnaire at Month 12|The subject satisfaction questionnaire was defined as satisfaction with overall treatment and support from health care providers during the last 12 months. Subjects were asked to rate their satisfaction by choosing either “Very unsatisfied, unsatisfied, satisfied or very satisfied”.|Month 12|"ITT population included all subjects randomized into the trial and have completed at least 1 post-baseline assessment of the questionnaires. Here, Overall Number of Participants Analyzed signifies those subjects who were evaluable for this outcome measure."||Subjects|||Number
664056|NCT01791244|Secondary|Number of Subjects With Response Based on Subject Satisfaction Questionnaire at Month 12|The subject satisfaction questionnaire was defined as satisfaction with overall treatment and support from health care providers during the last 12 months. Subjects were asked to rate their satisfaction by choosing either “Very discontented, discontented, contented or Very contented”.|Month 12|"ITT population included all subjects randomized into the trial and have completed at least 1 post-baseline assessment of the questionnaires. Here, Number of Subjects Analyzed signifies those subjects who were evaluable for this outcome measure."||Subjects|||Number
664057|NCT01791244|Secondary|Number of Subjects With Response Based on Lifestyle Questionnaire for (MinSupport Plus) at Month 6 and 12|Lifestyle Questionnaire was used to assess the quality of life for subjects based on following parameters: Stress, Alcohol, Cost, Physical Aspect, Sleep, Activity and Smoking. Subjects provided their responses on the basis of three color codes: Green, Orange and Red, where Green refers to – no problem; Orange refers to – some problem and red refers to – definite/debilitating problem.|Month 6 and 12|ITT population was used. Here, “Overall Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome Measure and “n” signifies those subjects who were evaluable for specified time points, respectively.||Subjects|||Number
664058|NCT01791244|Secondary|Percentage of Subjects With Adverse Events (AE) up to Month 12|AE was defined as any untoward medical occurrence which does not necessarily have a causal relationship with this the study drug. An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious AE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment Emergent Adverse Events (TEAEs) include both Serious TEAEs and non-serious TEAEs.|Baseline up to Month 12|The Safety Population included all subjects who were randomized and received at least 1 dose of trial treatment.||Percentage of Subjects|||Number
664059|NCT01791244|Secondary|Number of Subjects With Working Ability at Month 12|Working ability was assessed by measuring the number of subjects for the following categories: 1) Subjects with full sickness/disability pension, 2) Subjects who were employed or had their own business, 3) Subjects who were retired, 4) Subjects who were studying, 5) None of the above.|Month 12|ITT population included all subjects randomized into the trial and have completed at least 1 post-baseline assessment of the questionnaires. Here, “Overall Number of subjects analyzed” signifies those subjects who were evaluable for this outcome Measure.||Subjects|||Number
664060|NCT01791244|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score at Month 6 and 12|Hospital Anxiety and Depression Scale (HADS) was used to measure depression and anxiety in patients. The scale was limited to 14 questions, a practical tool for identifying and quantifying the two most common forms psychological disturbances in medical subjects. 7 of the items relate to anxiety and 7 relate to depression. Each item on the questionnaire was scored from 0-3 giving a total score between 0 and 21 for either anxiety or depression where higher score indicates more anxiety/depression.|Baseline, Month 6 and 12|ITT population included all subjects randomized into the trial and have completed at least 1 post-baseline assessment of the questionnaires.||units on a scale||Standard Deviation|Mean
664061|NCT01791244|Secondary|Change From Baseline in Modified Fatigue Impact Scale Index at Month 6 and 12|The Modified Fatigue Impact Index assesses fatigue- severity, distress, or degree of interference. Modified Fatigue Impact Scale Index was expressed in terms of percentage and ranged from 0% (no fatigue) to 100% (almost always impacted by fatigue).|Baseline, Month 6 and 12|ITT population included all subjects randomized into the trial and have completed at least 1 post-baseline assessment of the questionnaires. Here, “Number of subjects analyzed” signifies those subjects who were evaluable for this outcome Measure.||Percentage of fatigue||Standard Deviation|Mean
664062|NCT01791244|Secondary|Change From Baseline in Modified Fatigue Impact Scale Score at Month 6 and 12|The Modified Fatigue Impact Scale is a list of 21 statements describing how fatigue may affect a person's functioning. Answers ranging from 0 (Never) to 4 (Almost always). A total score ranged from a possible 0 (no fatigue impact) to 84 (almost always impacted by fatigue). A lower total score indicates less fatigue-related impact while a higher total score indicates greater fatigue-related impact on a subject's functioning.|Baseline, Month 6 and 12|"ITT population included all subjects randomized into the trial and have completed at least 1 post-baseline assessment of the questionnaires.. Here, Overall Number of subjects analyzed signifies those subjects who were evaluable for this outcome Measure."||units on a scale||Standard Deviation|Mean
664071|NCT01791205|Secondary|Phase II: Mean Change From Baseline in Aspartate Transaminase, Alanine Transaminase, Gamma-glutamyl Transpeptidase, and Alkaline Phosphatase Levels Over Time|Mean change from baseline in aspartate transaminase (AST), alanine transaminase (ALT), gamma-glutamyl transpeptidase (GGT) and alkaline phosphatase levels are reported.|From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy. Participants with available data at specified time points are denoted as ‘n’.||Units/Liter||Standard Deviation|Mean
664063|NCT01791244|Secondary|Change From Baseline in Fatigue Severity Scale (FSS) Score at Month 6 and 12|Fatigue Severity Scale (FSS) is a method of evaluating fatigue in multiple sclerosis and is designed to differentiate fatigue from clinical depression, since both share some of the same symptoms. The Fatigue Severity Scale is a 9-item questionnaire developed to assess the level of fatigue due to neurological disease, were each assessed on a 1-7 scale (1= no fatigue and 7= severe fatigue). The total score was calculated as the average of individual 9-items and ranged from 1 to 7 with a higher value indicating greater impairment due to fatigue.|Baseline, Month 6 and 12|ITT population included all subjects randomized into the trial and have completed at least 1 post-baseline assessment of the questionnaires.||units on a scale||Standard Deviation|Mean
664064|NCT01791244|Secondary|Percentage of Subjects With Treatment Adherence at Month 6 and 12|According to the World Health Organisation (WHO), treatment adherence is defined as both compliance (taking the medication in the correct dose and according to the schedule prescribed) and persistency (maintenance of the drug regimen over the long-term). Percentage of subjects with <10% missed injections (measured with the software RDS 2.0) during 6 and 12 months were reported.|Month 6 and 12|ITT population included all subjects randomized into the trial and have completed at least 1 post-baseline assessment of the questionnaires.||Percentage of Subjects|||Number
664065|NCT01791244|Secondary|Change From Baseline in Euro Quality of Life Questionnaire With 5 Questions Alternatives (EQ5D-5L) Visual Analogue Scale (VAS) Scale at Month 6 and 12|EQ-5D-5L VAS was used to record a subject’s rating for his/her current health-related quality of life state and captured on a vertical VAS (0-100), where 0 = worst imaginable health state and 100 = best imaginable health state.|Baseline, Month 6 and 12|ITT population included all subjects randomized into the trial and have completed at least 1 post-baseline assessment of the questionnaires.||units on a scale||Standard Deviation|Mean
664066|NCT01791244|Secondary|Change From Baseline in Euro Quality of Life Questionnaire With 5 Questions Alternatives (EQ5D-5L) Summary Score at Month 6 and 12|Quality of life was assessed using the EQ5D-5L score, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension comprises 5 levels with corresponding numeric scores ranging from 1 (no problems) through 5 (extreme problems) in which 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, and 5= extreme problems. A unique EQ5D-5L health state was defined by combining the numeric level scores for each of the 5 dimensions and the total score ranges from 5 to 25. An increase in the EQ5D-5L total score indicates worsening.|Baseline, Month 6 and 12|ITT population included all subjects randomized into the trial and have completed at least 1 post-baseline assessment of the questionnaires.||units on a scale||Standard Deviation|Mean
664067|NCT01791244|Secondary|Change From Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) Total Score at Month 6 and 12|Multiple Sclerosis Impact Scale-29 (MSIS-29) is a validated MS specific questionnaire consisting of 29 questions of which 20 addressed the physical impact component and 9 assessed the psychological impact. A combined score can be generated, or both components can be reported separately. The total score of the MSIS-29 was comprised of all the 29 questions in which subjects rate the impact of MS on their day-to-day life from 1=no impact to 5=extreme impact. The total Score was calculated using following formula: sum of score for 29 questions - 29/1.45. The total score range ranges from 0-100 where, lower total score indicates less psychologically-related impact while a higher total score indicates greater psychologically-related impact on a subject’s functioning.|Baseline, Month 6 and 12|ITT population included all subjects randomized into the trial and have completed at least 1 post-baseline assessment of the questionnaires.||units on a scale||Standard Deviation|Mean
664068|NCT01791244|Secondary|Change From Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) Psychological Score at Month 6|Multiple Sclerosis Impact Scale-29 (MSIS-29) is a validated MS specific questionnaire consisting of 29 questions of which 20 addressed the physical impact component and 9 assessed the psychological impact. A combined score can be generated, or both components can be reported separately. The psychological wellbeing assessment portion of the MSIS-29 was comprised of 9 questions in which subjects rate the impact of MS on their day-to-day life from 1=no impact to 5=extreme impact. The total Psychological Score was calculated using following formula: sum of score for 9 questions - 9/0.36. The total score range ranges from 0-100 where, lower total score indicates less psychologically-related impact while a higher total score indicates greater psychologically-related impact on a subject’s functioning.|Baseline and Month 6|ITT population included all subjects randomized into the trial and have completed at least 1 post-baseline assessment of the questionnaires.||units on a scale||Standard Deviation|Mean
664069|NCT01791244|Primary|Change From Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) Psychological Score at Month 12|Multiple Sclerosis Impact Scale-29 (MSIS-29) is a validated MS specific questionnaire consisting of 29 questions of which 20 addressed the physical impact component and 9 assessed the psychological impact. A combined score can be generated, or both components can be reported separately. The psychological wellbeing assessment portion of the MSIS-29 was comprised of 9 questions in which subjects rate the impact of MS on their day-to-day life from 1=no impact to 5=extreme impact. The total Psychological Score was calculated using following formula: sum of score for 9 questions - 9/0.36. The total score range ranges from 0-100 where, lower total score indicates less psychologically-related impact while a higher total score indicates greater psychologically-related impact on a subject’s functioning.|Baseline and Month 12|The ITT population included all subjects randomized into the trial and have completed at least 1 post-baseline assessment of the questionnaires.||units on a scale||Standard Deviation|Mean
664070|NCT01791205|Secondary|Phase II: Mean Change From Baseline in Serum Electrophoresis Parameters Over Time|Serum electrophoresis parameters includes albumin, alpha-1 globulin, alpha-2 globulin, beta globulin, gamma globulin was reported. Mean change from Baseline values are reported at each time points.|From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy. Participants with available data at specified time points are denoted as ‘n’.||Percentage of concentration||Standard Deviation|Mean
664091|NCT01791205|Secondary|Phase I: Mean Duration of Previous Treatment With a Biologic Drug in Monotherapy and Combination Therapy|Mean duration of previous treatment with a biologic drug in monotherapy are reported.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants. Participants who received previous treatment with a biologic drug before monotherapy were considered for this outcome measure.||Days||Standard Deviation|Mean
664072|NCT01791205|Secondary|Phase II: Mean Change From Baseline in Total Cholesterol, Low-density and High-density Lipoprotein Cholesterol, Triglycerides, Total Bilirubin, Direct Bilirubin, Glucose, Creatinine, Blood Urea Nitrogen Levels Over Time|Mean change from baseline in total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, triglycerides (TG), total bilirubin, direct bilirubin, glucose, creatinine, blood urea nitrogen (BUN) levels are reported.|From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy. Participants with available data at specified time points are denoted as ‘n’.||mg/dL||Standard Deviation|Mean
664073|NCT01791205|Secondary|Phase II: Mean Change From Baseline in Red Blood Cells, White Blood Cells, and Platelets Over Time|Mean change from baseline in red blood cells (RBC), white blood cells (WBC) and platelets are reported.|From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy. Participants with available data at specified time points are denoted as ‘n’.||10^6 cells/microliter||Standard Deviation|Mean
664074|NCT01791205|Secondary|Phase II: Mean Change From Baseline in Hematocrit, Neutrophils, Eosinophils, Basophils, Lymphocytes, and Monocytes Over Time|Mean Change from Baseline in hematocrit, neutrophils, eosinophils, basophils, lymphocytes, monocytes are reported.|From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy. Participants with available data at specified time points are denoted as ‘n’.||Percentage of cells||Standard Deviation|Mean
664075|NCT01791205|Secondary|Phase II: Mean Change From Baseline in Hemoglobin Levels Over Time|The mean change in hemoglobin concentration was calculated by subtracting the baseline hemoglobin concentration from the monthly hemoglobin concentration is reported.|From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy. Participants with available data at specified time points are denoted as ‘n’.||gram/dL||Standard Deviation|Mean
664076|NCT01791205|Secondary|Phase II: Number of Side Effects That Induced Transient Interruption of Treatment|Number of side effects (AEs) that induced transient interruption of treatment is reported. The AEs were captured only for Phase II.|Up to 18 months|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy.||AEs|||Number
664077|NCT01791205|Secondary|Phase II: Number of Side Effects That Had Not Induced Discontinuation of Treatment|Number of side effects (AEs) that had not induced discontinuation of treatment is reported. The AEs were captured only for Phase II.|Up to 18 months|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy.||AEs|||Number
664078|NCT01791205|Secondary|Phase II: Number of Participants With Retention in Therapy Without Interruption Due to Side Effects|Number of participants who retained in therapy without interruption due to side effects is reported.|Up to 18 months|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy.||Participants|||Number
664079|NCT01791205|Secondary|Phase II: Number of Participants With Any Adverse Events, Any Serious Adverse Events, Adverse Events of Special Interest, and Tubercular Events|An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable or unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Pre-existing conditions that worsened during the study were reported as AE. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death is life threatening, requires hospitalization or prolongation of hospitalization, or results in disability/incapacity, or congenital anomaly/birth defect. The AE were captured only for Phase II.|Up to 18 months|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy.||Participants|||Number
664080|NCT01791205|Secondary|Phase II: Mean VAS Fatigue Score Overtime|The VAS fatigue score ranging from 0 (symptom-free and no arthritis symptoms) to 100 (worsening in symptoms and arthritis disease activity). Higher score indicate worsening.|At Baseline (Day of first administration of TCZ as a monotherapy) and Months 3, 6, 12, and 18|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy. Participants with available data at specified time points are denoted as ‘n’.||Scores on scale||Standard Deviation|Mean
664081|NCT01791205|Secondary|Phase II: Percentage of Participants With Delta HAQ >= 0.21 at Months 3, 6, 12, and 18|Percentage of participants with change in HAQ (Delta HAQ) of >= 0.21 after 3, 6, 12 and 18 months from the first infusion with tocilizumab as monotherapy are reported. The HAQ consisted of 20 questions in eight domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities) rated on a 4-point scale, where 0 (equals) = without difficulties; 1= with some difficulties; 2= with great difficulties; and 3= unable to perform these actions at all. The HAQ-DI scale was an average of all the scores and ranged from 0 (mild disability) to 3 (severe disability), where higher scores represents higher disease activity.|At Months 3, 6, 12, and 18|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy.||Percentage of participants||95% Confidence Interval|Number
664082|NCT01791205|Secondary|Phase II: Mean Change From Baseline in Dose of Corticosteroids at Months 3, 6, 12, and 18|Mean Change From Baseline (day of the first infusion with tocilizumab as monotherapy) in the dose of corticosteroids after 3, 6, 12 and 18 months from Baseline is reported.|From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy. Participants with available data at specified time points are denoted as ‘n’.||milligrams||Standard Deviation|Mean
664092|NCT01791205|Secondary|Phase I: Mean Dose of Corticosteroids At Study Entry in Monotherapy and Combination Therapy|Mean dose of corticosteroids at study entry (Baseline) is reported.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants. Participants who received corticosteroids were considered for this outcome measure.||milligrams||Standard Deviation|Mean
664083|NCT01791205|Secondary|Phase II: Mean Change From Baseline in TJC And SJC at Months 3, 6, 12, and 18|The mean change from Baseline (day of the first infusion with tocilizumab as monotherapy) in the TJC And SJC after 3, 6, 12 and 18 months is reported. The TJC and SJC were determined for 28 joint counts. The scores ranged from 0 (no disease activity) to 28 (higher/worsen disease activity), where higher scores represents higher disease activity.|From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy. Participants with available data at specified time points are denoted as ‘n’.||Joints||Standard Deviation|Mean
664084|NCT01791205|Secondary|Phase II: Percentage of Participant Achieving SDAI Remission (< 3.3) at Months 3, 6, 12, and 18|Percentage of participant achieving SDAI remission (< 3.3), after 3, 6, 12 and 18 months from the first infusion with tocilizumab as monotherapy is reported. The SDAI is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PhGA which (based on 0-10 cm VAS, 0 = no disease activity and 10 = worst disease activity, where higher scores represent higher disease activity), and CRP. The SDAI total score ranges from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity. The SDAI =< 3.3 indicates disease remission, > 3.4 to 11 = low disease activity, > 11 to 26 = moderate disease activity, and > 26 = high disease activity.|At Months 3, 6, 12, and 18|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy.||Percentage of participants||95% Confidence Interval|Number
664085|NCT01791205|Secondary|Phase II: Percentage of Participants Achieving CDAI Remission (< 2.8) at Months 3, 6, 12, and 18|Percentage of participants achieving CDAI remission < 2.8, after 3, 6, 12 and 18 months from the first infusion with tocilizumab as monotherapy are reported. CDAI is the numerical sum of four outcome parameters: TJC, SJC based on a 28-joint assessment; and PtGA and PhGA assessed on 0-10 cm VAS, where 0 = no disease activity and 10 = worst disease activity, where higher scores represents higher disease activity. The CDAI total score ranges from 0 (no disease activity) to 76 (maximal disease activity), where higher scores represents higher disease activity. The CDAI =< 2.8 indicates clinical remission, > 2.8 to 10 indicates low disease activity, > 10 to 22 indicates moderate disease activity, and > 22 indicates high disease activity.|At Months 3, 6, 12, and 18|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy.||Percentage of participants||95% Confidence Interval|Number
664086|NCT01791205|Secondary|Phase II: Percentage of Participants Achieving DAS 28 ESR (< 2.6) and Low Disease Activity (<3.2) at Months 3, 6, 12, and 18|The DAS28 ESR is a measure of the participant’s disease activity calculated using TJC (28 joints), SJC (28 joints), PtGA using 0-10 cm VAS (0 = no disease activity and 10 = worst disease activity), and ESR. It is calculated by using the following formula: DAS28 ESR = 0.56 x square root of TJC + 0.28 x square root of SJC + 0.70 x log n at ESR + 0.014 x PtGA. The DAS28 ESR scores ranged from 0.49 (less disease activity) to 9.07 (maximal disease activity); decrease in score indicated improvement of disease. The DAS28 ESR < 2.6 indicates disease remission and >=2.6 to 3.2 indicates low disease activity.|At Months 3, 6, 12, and 18|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy.||Percentage of participants||95% Confidence Interval|Number
664087|NCT01791205|Secondary|Phase II: Percentage of Participants Achieving DAS28 CRP Remission (< 2.6) and Low Disease Activity (<3.2) at Months 3, 6, 12, and 18|The DAS28-CRP is a combined index that measured RA disease activity. It is calculated using TJC (28 joints), SJC (28 joints), PtGA using 0-10 cm VAS (0 = no disease activity and 10 = worst disease activity), and CRP (mg/dL). It is calculated by using the formula: DAS28 CRP= 0.56 × square root of TJC (28 joints) + 0.28 square root of SJC (28 joints) + 0.36 × log n at (CRP+1) + 0.014 × PtGA + 0.96. The DAS28 CRP scores ranged from 0.49 (less disease activity) to 9.07 (maximal disease activity); decrease in score indicated improvement of disease. The DAS28 CRP < 2.6 indicates disease remission and >=2.6 to 3.2 indicates low disease activity.|At Months 3, 6, 12, and 18|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy.||Percentage of participants||95% Confidence Interval|Number
664088|NCT01791205|Secondary|Phase II: Percentage of Participants Maintaining Delta DAS28 ESR >= 0.6 at Months 3, 6, 12, and 18|Participants who maintained delta DAS28 ESR of >= 0.6 after 3, 6, 12, and 18 months from the first infusion with tocilizumab as monotherapy are reported. The DAS28 ESR is a measure of the participant’s disease activity calculated using TJC (28 joints), SJC (28 joints), PtGA using 0-10 cm VAS (0 = no disease activity and 10 = worst disease activity), and ESR. It is calculated by using the following formula: DAS28 ESR = 0.56 x square root of TJC + 0.28 x square root of SJC + 0.70 x log n at ESR + 0.014 x PtGA. The DAS28 ESR scores ranged from 0.49 (less disease activity) to 9.07 (maximal disease activity); where decrease in score indicated improvement of disease.|At Months 3, 6, 12, and 18|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy.||Percentage of participants||95% Confidence Interval|Number
664089|NCT01791205|Secondary|Phase II: Percentage of Participants Maintaining Delta DAS 28 CRP of >= 0.6 at Months 3, 6, 12, and 18|Participants who maintained the change in DAS28 (Delta DAS28) CRP of >=0.6 after 3, 6, 12, and 18 months from the first infusion with tocilizumab as monotherapy are reported. The DAS28-CRP is a combined index that measured RA disease activity. It is calculated using TJC (28 joints), SJC (28 joints), PtGA using 0-10 cm VAS (0 = no disease activity and 10 = worst disease activity), and CRP (mg/dL). It is calculated by using the formula: DAS28 CRP= 0.56 × square root of TJC 28 + 0.28 square root of SJC 28 + 0.36 × log n at (CRP+1) + 0.014 × PtGA + 0.96. The DAS28 CRP- scores ranged from 0.49 (less disease activity) to 9.07 (maximal disease activity); decrease in score indicated improvement of disease.|At Months 3, 6, 12, and 18|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy.||Percentage of participants||95% Confidence Interval|Number
664090|NCT01791205|Secondary|Phase I: Mean Duration of Treatment With A Biologic Drug in Combination With DMARDs Before Monotherapy|Mean duration of treatment with a biologic drug in combination with DMARDs before monotherapy is reported in days.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants. Participants who received previous treatment with a biologic drug in combination with DMARDs before monotherapy were considered for this outcome measure.||Days||Standard Deviation|Mean
664104|NCT01791205|Secondary|Phase I: Median Disease Duration in Monotherapy and Combination Therapy|The duration of disease is defined as the total time from the diagnosis of RA until the study entry.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants.||Months||95% Confidence Interval|Median
664093|NCT01791205|Secondary|Phase I: Percentage of Participants Treated With Corticosteroids at Study Entry in Monotherapy and Combination Therapy|The percentage of participants treated with corticosteroids at enrollment is reported.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants.||Percentage of participants||95% Confidence Interval|Number
664094|NCT01791205|Secondary|Phase I: Mean Tender Joints and Swollen Joints as Disease Activity at Study Entry in Monotherapy and Combination Therapy|Mean of tender and swollen joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender and swollen joints was recorded on the joint assessment as no tenderness = 0 and tenderness = 1.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants. Participants with available tender and swollen joints at Baseline are reported.||Joints||Standard Deviation|Mean
664095|NCT01791205|Secondary|Phase I: Number of Participants With SDAI Scores at Study Entry in Monotherapy and Combination Therapy|The SDAI is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PhGA (assessed on 0-10 cm) VAS; 0 = no disease activity and 10 = worst disease activity), and CRP (mg/dL). SDAI total score ranges from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity. The SDAI =< 3.3 indicates disease remission, > 3.4 to 11 indicates low disease activity, > 11 to 26 indicates moderate disease activity, and > 26 indicates high disease activity.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants. Participants with available SDAI score at Baseline are reported.||Participants|||Number
664096|NCT01791205|Secondary|Phase I: Number of Participants With CDAI Scores at Study Entry in Monotherapy and Combination Therapy|The CDAI is the numerical sum of four outcome parameters: TJC and SJC based on a 28-joint assessment; and PtGA and PhGA assessed on 0-10 cm VAS, where 0 = no disease activity and 10 = worst disease activity, where higher scores represents higher disease activity. The CDAI total score ranges from 0 (no disease activity) to 76 (maximal disease activity), where higher scores represents higher disease activity. The CDAI =< 2.8 indicates clinical remission, > 2.8 to 10 indicates low disease activity, > 10 to 22 indicates moderate disease activity, and > 22 indicates high disease activity. Number of participants with CDAI scores for both the groups at study entry (baseline) are reported.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants. Participants with available CDAI score at Baseline are reported.||Participants|||Number
664097|NCT01791205|Secondary|Phase I: Median DAS28 at Study Entry in Monotherapy and Combination Therapy|The DAS28 is a combined index for measuring disease activity in RA. The index includes SJC and TJC, acute phase response, and general health status. The DAS28 scale ranges from 0 to 10 (0= no disease activity and 10= maximum disease activity) where higher scores represents higher disease. The DAS28 <2.6 indicates disease remission, >=2.6 and <3.2 indicates Low disease activity, >=3.2 and <=5.1 indicates Moderate disease activity and >5.1 indicates High disease activity. Median score for DAS28 at the study entry (Baseline) is reported.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants. Participants with available DAS28 score at Baseline are reported.||Scores on scale||Full Range|Median
664098|NCT01791205|Secondary|Phase I: Percentage of Participants With Prevalence of Previous Therapy Switches and Swaps in Monotherapy and Combination Therapy|Participants who had prevalence with at least one previous switch, swaps or switch/swap to other therapy either monotherapy or combination therapy are reported.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants.||Percentage of participants||95% Confidence Interval|Number
664099|NCT01791205|Secondary|Phase I: Number of Participants With at Least One Previous Treatment With Biologics Drug as a Monotherapy in Monotherapy and Combination Therapy|Number of participants who received at least one previous treatment with a biologic drug as a monotherapy in both groups is reported.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants. One participant in monotherapy group and 4 participants in combination group were not included because they had not received a previous treatment.||Participants|||Number
664100|NCT01791205|Secondary|Phase I: Number of Participants Receiving a Biologic Drug as Monotherapy at Different Treatment Lines|The first biologic treatment line was defined as the first use of any biologic drug in treatment of rheumatoid arthritis, regardless its association with DMARDs, the second treatment line as the subsequent use of a different biologic drug and so on for the third, fourth, fifth and sixth treatment line. According to the study protocol objectives, this analysis was performed only for Monotherapy arm.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants.||Participants|||Number
664101|NCT01791205|Secondary|Phase I: Percentage of Participants Who Started Treatment With a Biologic Drug in Monotherapy and Percentage of Participants Who Stopped a DMARDs While Taking a Biologic Drug in Combination Therapy|The table below shows percentage participants who started treatment with a biologic drug in monotherapy compared with percentage of participants who stopped DMARDs while taking a biologic drug in combination.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants. One participant in monotherapy group and 4 participants in combination group were not included because they had not received a previous treatment.||Percentage of Participants||95% Confidence Interval|Number
664102|NCT01791205|Secondary|Phase I: Mean Health Assessment Questionnaire-Disability Index in Monotherapy and Combination Therapy|The HAQ-DI is a participant-reported questionnaire that measured quality of life in terms of physical function of participants with rheumatoid arthritis. It consisted of 20 questions in eight domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities) rated on a 4-point scale, where 0 (equals) = without difficulties; 1= with some difficulties; 2= with great difficulties; and 3= unable to perform these actions at all. The HAQ-DI scale was an average of all the scores and ranged from 0 (mild disability) to 3 (severe disability), where higher scores represents higher disease activity. Participants assessed their ability to do each task over the past seven days.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants.||Scores on scale||Standard Deviation|Mean
664103|NCT01791205|Secondary|Phase I: Percentage of Participants With Comorbidity in Monotherapy and Combination Therapy|Comorbidity is the presence of previous or concomitant diseases. Percentage of participants with comorbidity is reported.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants.||Percentage of participants|||Number
664105|NCT01791205|Primary|Phase II: Retention Rate in Therapy, Percentage of Participants Achieving DAS 28 ESR <2.6 and <3.2 at Month 18|Participants who retained the therapy were analyzed for disease activity (DAS28 ESR) at Month 18. The DAS28 ESR is a measure of the participant’s disease activity calculated using TJC (28 joints), SJC (28 joints), PtGA using 0-10 cm VAS (0 = no disease activity and 10 = worst disease activity), and ESR. It is calculated by using the following formula: DAS28 ESR = 0.56 x square root of TJC + 0.28 x square root of SJC + 0.70 x log n at ESR + 0.014 x PtGA. The DAS28 ESR scores ranged from 0.49 (less disease activity) to 9.07 (maximal disease activity); decrease in score indicated improvement of disease.|At month 18|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy.||Percentage of participants||95% Confidence Interval|Number
664106|NCT01791205|Primary|Phase II: Percentage of Participants Who Retained on Tocilizumab Monotherapy|The probabilities of participant to retain on therapy at various time points are reported.|Up to 18 months|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy.||Percentage of participants||95% Confidence Interval|Number
664107|NCT01791205|Primary|Phase I: Number of Participants With Reasons Leading to the Use of Biologic in Monotherapy|Reasons leading to the use of biologic in monotherapy includes DMARDs intolerance, insufficient therapeutic effect, intolerance to biologic drug, low participant's compliance, concomitant pathologies, pregnancy desire, remission from combination therapy, remission from monotherapy, others and unknown. Participants with reason leading to the use of biologic in monotherapy are presented. According to the study protocol objectives, this analysis was performed only for Monotherapy arm.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants.||Participants|||Number
664108|NCT01791205|Primary|Phase I: Number of Participants With Prevalence of Previous Therapy Switches and Swaps in Monotherapy and Combination Therapy|Participants who had prevalence with at least one previous switch, swaps, and switch/swap to other therapy are reported.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants.||Participants|||Number
664109|NCT01791205|Primary|Phase I: Number of Biologics Administered as Monotherapy in Monotherapy and Combination Therapy|Participants who received at least one previous treatment with biologics in monotherapy and no previous monotherapy with biologics are reported.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants.||Participants|||Number
664110|NCT01791205|Primary|Phase I: Number of Participants Treatment Line in Which Monotherapy Has Been Adopted in Monotherapy|The first biologic treatment line was defined as the first use of any biologic drug in treatment of rheumatoid arthritis, regardless its association with DMARDs and the second treatment line as the subsequent use of a different biologic drug. Participants who adopted monotherapy as =< 2 and > 2 therapy lines are reported. According to the study protocol objectives, this analysis was performed only for Monotherapy arm.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants.||Participants|||Number
664111|NCT01791205|Primary|Phase I: Number of Participants With Duration of Combination Therapy Before Monotherapy in Monotherapy and Combination Therapy|The duration of combination therapy before monotherapy are reported. The duration was estimated by calculating total duration from starting the combination therapy till the participant switched to monotherapy. Participants who started the combination therapy and later switched to monotherapy =< 337 days, > 337 days, =< 336 days, > 336 days are reported.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants. Participants with available data at specified time points are denoted as ‘n’.||Participants|||Number
664112|NCT01791205|Primary|Phase I: Number of Participants With Simplified Disease Activity Index in Monotherapy and Combination Therapy|The disease activity included Simplified Disease Activity Index (SDAI) which is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PhGA (based on 0-10 cm VAS, where 0 = no disease activity and 10 = worst disease activity), and CRP. SDAI total score ranges from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity. The SDAI =< 3.3 indicates disease remission, > 3.4 to 11 indicates low disease activity, > 11 to 26 indicates moderate disease activity, and > 26 indicates high disease activity. Participants with SDAI score =< 8.17 and > 8.17 are reported.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants. Participants with available data at Baseline are reported.||Participants|||Number
664113|NCT01791205|Primary|Phase I: Number of Participants With Clinical Disease Activity Index in Monotherapy and Combination Therapy|The disease activity included Clinical Disease Activity Index (CDAI) which is the numerical sum of four outcome parameters: TJC and SJC based on a 28-joint assessment; and patient’s global assessment (PtGA) and physician’s global assessment (PhGA) assessed on 0-10 cm visual analog scale (VAS), where 0 = no disease activity and 10 = worst disease activity, where higher scores represents higher disease activity. The CDAI total score ranges from 0 (no disease activity) to 76 (maximal disease activity), where higher scores represents higher disease activity. The CDAI =< 2.8 indicates clinical remission, > 2.8 to 10 indicates low disease activity, > 10 to 22 indicates moderate disease activity, and > 22 indicates high disease activity. Participants with CDAI score =< 7.75 and > 7.75 are reported.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants. Participants with available data at Baseline are reported.||Participants|||Number
664114|NCT01791205|Primary|Phase I: Number of Participants With C-Reactive Protein Value and Erythrocyte Sedimentation Rate in Monotherapy and Combination Therapy|The disease activity included biological markers of inflammation: C-Reactive Protein (CRP) and Erythrocyte Sedimentation Rate (ESR). A reduction in CRP and ESR values indicates improvement. Participants with CRP values =< 0.28 and >2.8 milligram/deciliter (mg/dL); and ESR values =< 11 and >11 millimeters/hour (mm/hr) are reported.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants. Participants with available data at Baseline are reported. Participants with available data at specified time points are denoted as ‘n’.||Participants|||Number
664128|NCT01791153|Secondary|Maximum Serum Concentration at Steady State (Cmax,ss) of Tocilizumab|Cmax,ss is maximum model-predicted serum steady state concentration of tocilizumab measured in micrograms per milliliter (mcg/mL).|Baseline and Week 16 (Predose [Hour 0], 24, 48, 72, 96, and 120 or 144 hours postdose); Weeks 1, 2, 17, and 18 (Predose [Hour 0])|PK-evaluable population||mcg/mL||Standard Deviation|Mean
666041|NCT01763905|Secondary|Percent Change From Baseline in the Total Cholesterol/High Density Lipoprotein Cholesterol Ratio at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
664115|NCT01791205|Primary|Phase I: Number of Participants With Disease Activity Score 28 in Monotherapy and Combination Therapy|The disease activity included Disease Activity Score 28 (DAS28). The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen joint counts (SJC) and tender joint counts (TJC), acute phase response, and general health status. The DAS28 scale ranges from 0 to 10 (0= no disease activity and 10= maximum disease activity; where higher scores represents higher disease activity. The DAS =< 2.8 indicates clinical remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high disease activity. Participants with DAS28 score =< 2.6 and > 2.6 are reported.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants. Participants with available data at Baseline are reported.||Participants|||Number
664116|NCT01791205|Primary|Phase I: Number of Participants With Health Assessment Questionnaire- Disability Index in Monotherapy and Combination Therapy|The Health Assessment Questionnaire- Disability Index (HAQ-DI) is a participant-reported questionnaire that measured quality of life in terms of physical function of participants with rheumatoid arthritis. It consisted of 20 questions in eight domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities) rated on a 4-point scale, where 0 (equals) = without difficulties; 1= with some difficulties; 2= with great difficulties; and 3= unable to perform these actions at all. The HAQ-DI scale was an average of all the scores and ranged from 0 (mild disability) to 3 (severe disability), where higher scores represents higher disease activity. Participants assessed their ability to do each task over the past seven days. Participants with scores =< 0.8625 and > 0.8625 are reported.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants. Participants with available data at the time of evaluation are reported.||Participants|||Number
664117|NCT01791205|Primary|Phase I: Number of Participants With Autoantibody Status (Rheumatoid Factor and Anti-cyclic Citrullinated Protein Antibodies) in Monotherapy and Combination Therapy|The autoantibody included seropositive or seronegative participants for rheumatoid factor (RF) and/or anti-cyclic citrullinated protein antibodies (Anti-CCP). RF value higher than 20 Units (U)/milliliter (mL) is considered seropositive and anti-CCP antibodies value higher than 10 U/mL is considered positive.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants. Participants with available data at specified time points are denoted as ‘n’.||Participants|||Number
664118|NCT01791205|Primary|Phase I: Number of Participants With Comorbidity in Monotherapy and Combination Therapy|Comorbidity is the presence of previous or concomitant diseases.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants.||Participants|||Number
664119|NCT01791205|Primary|Phase I: Number of Participants With Disease Duration in Monotherapy and Combination Therapy|The duration of disease is defined as the total time from the diagnosis of rheumatoid arthritis (RA) until the study entry.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants.||Participants|||Number
664120|NCT01791205|Primary|Phase I: Number of Participants With Demographic Characteristics in Monotherapy and Combination Therapy|Demographic characteristics were analyzed in participants at Baseline, where Baseline is considered as the study entry visit (day of informed consent form signed). Demographic characteristics which were taken into account included age in years, race, height in centimeters (cm), weight in Kilograms (Kg), and Body Mass Index (BMI) in Kg/cm^2. Participants with age =<, > 59 years, height =<, > 163 cm, weight =<, > 65.85 Kg and BMI =<, > 24.98 Kg/cm^2 are reported.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants. Participants with available data at specified time points are denoted as ‘n’.||Participants|||Number
664121|NCT01791153|Secondary|Percentage of Participants With Anti-Tocilizumab Antibodies|All samples were tested by screening assay, and those samples that were positive were further analyzed by a confirmation assay to confirm specificity. Percentage of participants who has a positive confirmation assay result any time after the initial drug administration with a negative confirmation assay result at baseline was reported.|Baseline up to Week 52|Safety population. Here, 'Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.||percentage of participants|||Number
664122|NCT01791153|Secondary|C-Reactive Protein (CRP) Level|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline and Week 52|Safety population. Here, 'n' signifies the number of participants evaluable at specified time point for different arms, respectively.||milligrams per liter (mg/L)||Inter-Quartile Range|Median
664123|NCT01791153|Secondary|Erythrocyte Sedimentation Rate (ESR)|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.|Baseline and Week 52|Safety population. Here, 'n' signifies the number of participants evaluable at specified time point for different arms, respectively.||mm/hr||Inter-Quartile Range|Median
664124|NCT01791153|Secondary|Serum Soluble IL-6 Receptor (sIL-6R) Level||Baseline and Week 52|Safety population. Here, 'n' signifies the number of participants evaluable at specified time point for different arms, respectively.||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
664125|NCT01791153|Secondary|Serum Interleukin-6 (IL-6) Level||Baseline and Week 52|Safety population. Here, 'n' signifies the number of participants evaluable at specified time point for different arms, respectively.||picograms per milliliter (pg/mL)||Standard Deviation|Mean
664126|NCT01791153|Secondary|Minimum Observed Serum Concentration (Ctrough) of Tocilizumab|Ctrough is minimum observed serum concentration of tocilizumab measured in mcg/mL.|Predose (Hour 0) at Baseline and Week 52|PK-evaluable population. Here, 'Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point for different arms, respectively.||mcg/mL||Standard Deviation|Mean
664127|NCT01791153|Secondary|Minimum Serum Concentration at Steady State (Cmin,ss) of Tocilizumab|Cmin,ss is minimum model-predicted serum steady state concentration of tocilizumab measured in mcg/mL.|Baseline and Week 16 (Predose [Hour 0], 24, 48, 72, 96, and 120 or 144 hours postdose); Weeks 1, 2, 17, and 18 (Predose [Hour 0])|PK-evaluable population||mcg/mL||Standard Deviation|Mean
664282|NCT01788163|Primary|Overall Tumour Epidermal Growth Factor Receptor (EGFR) Mutation Status|The 95% Confidence intervals were calculated using Clopper Pearson method for each country.|At Screening|Tumour Evaluable Population||Percentage of participants||95% Confidence Interval|Number
664129|NCT01791153|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) at Steady State of Tocilizumab|AUCtau is the model-predicted area under the tocilizumab serum concentration versus time curve from time zero to the end of dosing interval. AUCtau is measured in microgram*day per milliliter (mcg*day/mL).|Baseline and Week 16 (Predose [Hour 0], 24, 48, 72, 96, and 120 or 144 hours postdose); Weeks 1, 2, 17, and 18 (Predose [Hour 0])|Pharmacokinetics (PK)-evaluable population included all participants who received at least one tocilizumab injection and had at least one PK sample with detectable results taken at any time during the study.||mcg*day/mL||Standard Deviation|Mean
664130|NCT01791153|Secondary|Change From Baseline in Patient Global Assessment (PGA) of Disease Activity Assessed Using Visual Analogue Scale (VAS) at Week 52|Participants assessed their current disease activity on a 0-100 millimeter (mm) VAS, where 0 mm = no disease activity and 100 mm = maximum disease activity. A negative change from baseline indicates improvement.|Baseline, Week 52|ITT population. Here, 'Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point for different arms, respectively.||mm||Standard Deviation|Mean
664131|NCT01791153|Secondary|Change From Baseline in Short Form (SF)-36 Questionnaire Score at Week 52|The SF-36 is a standardized questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical Component Score (PCS) and Mental Component Score (MCS). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). A positive change from baseline indicates improvement. No imputation was used for missing data. Data was set to missing for participants who received escape therapy.|Baseline, Week 52|ITT population. Here, 'Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point for different arms, respectively.||units on a scale||Standard Deviation|Mean
664132|NCT01791153|Secondary|Total Cumulative Prednisone Dose|The median total cumulative prednisone dose over the 52 weeks for each treatment group and the corresponding 95% confidence intervals are presented.|Up to 52 weeks|ITT Population||milligrams (mg)||95% Confidence Interval|Median
664133|NCT01791153|Secondary|Time to First GCA Disease Flare|Flare was determined by the investigator and was defined as the recurrence of signs or symptoms of GCA and/or ESR >/=30 mm/hr attributable to GCA. Participants who withdrew from the study prior to Week 52 were censored from the time of withdrawal.|Up to 52 weeks|ITT population||days||99% Confidence Interval|Median
664134|NCT01791153|Secondary|Percentage of Participants in Sustained Remission at Week 52 (Tocilizumab + 26 Weeks Prednisone Taper Versus Placebo + 52 Weeks Prednisone Taper)|Remission was defined as the absence of flare and normalization of the CRP (<1 mg/dL). Sustained remission was defined as the absence of flare following induction of remission within 12 weeks of randomization and maintained up to Week 52. Flare was determined by the investigator and was defined as the recurrence of signs or symptoms of GCA and/or ESR >/=30 mm/hr attributable to GCA. A single CRP elevation (>/=1 mg/dL) was not considered as a sign of flare, unless the CRP remained elevated (>/=1 mg/dL) at the next study visit.|Week 52|ITT population||percentage of participants|||Number
664135|NCT01791153|Primary|Percentage of Participants in Sustained Remission at Week 52 (Tocilizumab + 26 Weeks Prednisone Taper Versus Placebo + 26 Weeks Prednisone Taper)|Remission was defined as the absence of flare and normalization of the C-reactive protein (CRP) (less than [<] 1 milligram per deciliter [mg/dL]). Sustained remission was defined as the absence of flare following induction of remission within 12 weeks of randomization and maintained up to Week 52. Flare was determined by the investigator and was defined as the recurrence of signs or symptoms of GCA and/or erythrocyte sedimentation rate (ESR) greater than or equal to (>/=) 30 millimeters per hour (mm/hr) attributable to GCA. A single CRP elevation (>/=1 mg/dL) was not considered as a sign of flare, unless the CRP remained elevated (>/=1 mg/dL) at the next study visit.|Week 52|Intent-to-treat (ITT) population included all participants randomized into the study who received at least one administration of study drug.||percentage of participants|||Number
664136|NCT01789775|Primary|Composite Success Assessment (CEA) and Patient Self Assessment(PSA).|Composite Success is defined as 1-grade improvement on both Clinician Erythema Assessment (CEA) and Patient Self Assessment(PSA).|Day 29|||participants|||Number
664137|NCT01789775|Secondary|Composite Success Assessment (CEA) and Patient Self Assessment(PSA).|30 Minutes Effect is defined as 1 grade improvement on CEA and PSA at 30 minutes.|D1||||||
664138|NCT01790828|Secondary|Total Factor Consumption for On-Demand Therapy and During Prophylaxis in Participants ≥18 Years of Age||4 years|All enrolled participants; only participants ≥18 years were included in the analysis; participants were excluded from the analysis if total number of infusions for prophylaxis was unknown.||IU||Standard Deviation|Mean
664139|NCT01790828|Secondary|Total Factor Consumption for On-Demand Therapy and During Prophylaxis in Participants <18 Years of Age||4 years|All enrolled participants; only participants <18 years were included in the analysis and participants were excluded from the analysis if total number of infusions for prophylaxis was unknown.||IU||Full Range|Median
664140|NCT01790828|Secondary|Total Factor Consumption for On-Demand Therapy and During Prophylaxis (All Participants)||4 years|All enrolled participants; participants were excluded from the analysis if total number of infusions for prophylaxis was unknown.||IU||Standard Deviation|Mean
664141|NCT01790828|Secondary|Average Infusion Dose During Prophylaxis in Participants ≥18 Years of Age||4 years|All enrolled participants; only participants ≥18 years with nonmissing data were included in the analysis.||IU||Standard Deviation|Mean
664142|NCT01790828|Secondary|Average Infusion Dose During Prophylaxis in Participants <18 Years of Age||4 years|All enrolled participants; only participants <18 years were included in the analysis.||IU||Standard Deviation|Mean
664143|NCT01790828|Secondary|Average Infusion Dose During Prophylaxis (All Participants)||4 years|All enrolled participants; only participants with nonmissing data were included in the analysis.||IU||Standard Deviation|Mean
664144|NCT01790828|Secondary|Number of Participants With LETE Bleeds Within 48 Hours of a Preventive/Prophylaxis Dose of Xyntha|Less than expected therapeutic effect for prophylaxis therapy defined as breakthrough (spontaneous/non-traumatic) bleed wtihin 48 hours of prophylaxis infusion.|4 years|Data were not analyzed as information on breakthrough bleeds within 48 hours was not collected.|||||
664145|NCT01790828|Secondary|Annualized Bleeding Rates During Prophylaxis|Annualized bleeding rate defined as total number of breakthrough bleeds within 48 hours (for prophylaxis purpose) divided by (/) [(total period of date of bleeding)/365.25)]|4 years|Data were not analyzed as information on breakthrough bleeds within 48 hours was not collected.|||||
664146|NCT01790828|Secondary|Percentage of Participants Experiencing Hemorrhages During Prophylaxis||4 years|All enrolled participants; n (number) equals (=) number of participants with nonmissing values||percentage of participants|||Number
664147|NCT01790828|Secondary|Average Infusion Dose Per Bleeding for On-Demand Therapy in Participants ≥18 Years of Age||4 years|All enrolled participants; only participants ≥18 years who received on-demand therapy were included in the analysis.||IU||Standard Deviation|Mean
664148|NCT01790828|Secondary|Average Infusion Dose Per Bleeding for On-Demand Therapy in Participants <18 Years of Age||4 years|All enrolled participants; only participants <18 years who received on-demand therapy were included in the analysis.||IU||Full Range|Median
664149|NCT01790828|Secondary|Average Infusion Dose Per Bleeding for On-Demand Therapy (All Participants)||4 years|All enrolled participants; only participants who received on-demand therapy were included in the analysis.||IU||Standard Deviation|Mean
664150|NCT01790828|Secondary|Number of Participants With Less-Than-Expected Therapeutic Effect (LETE) for On-Demand Therapy|Less than expected therapeutic effect was defined as a 'no response' rating after each of two successive infusions less than or equl to (≤) 24 hours of on-demand therapy.|4 years|Data were not analyzed as no participants experienced rating of 'no response'.|||||
664151|NCT01790828|Secondary|Number of Responses by Type of Response for All Xyntha Infusions for Treatment of a Bleed for On-Demand Therapy in Participants ≥18 Years of Age|Response categories were excellent, good, moderate, and no response.|4 years|All enrolled participants; only participants ≥18 years who receive don-demand therapy were included in the analysis.||number of responses|Participants||Number
664152|NCT01790828|Secondary|Number of Responses by Type of Response for All Xyntha Infusions for Treatment of a Bleed for On-Demand Therapy in Participants <18 Years of Age|Response categories were excellent, good, moderate, or no response.|4 years|All enrolled participants; only participants <18 years who received on-demand therapy were included in the analysis.||number of responses|Participants||Number
664153|NCT01790828|Secondary|Number of Responses by Type of Response for All Xyntha Infusions for Treatment of a Bleed for On-Demand Therapy (All Participants)|Response categories were excellent, good, moderate, or no response.|4 years|All enrolled participants; only participants who received on-demand therapy were included in the analysis.||Number of responses|Participants||Number
664154|NCT01790828|Secondary|Number of Xyntha Infusions Used to Treat Each New Bleed for On-Demand Therapy in Participants Greater Than or Equal to (≥) 18 Years of Age||4 years|All enrolled participants; participants aged ≥18 years who received on-demand therapy were included in the analysis.||infusions||Standard Deviation|Mean
664155|NCT01790828|Secondary|Number of Xyntha Infusions Used to Treat Each New Bleed for On-Demand Therapy in Participants Less Than (<)18 Years of Age||4 years|All enrolled participants; only participants aged <18 years who received on-demand therapy were included in the analysis.||infusions||Standard Deviation|Mean
664156|NCT01790828|Secondary|Number of Xyntha Infusions Used to Treat Each New Bleed for On-Demand Therapy (All Participants)||4 years|All enrolled participants; only participants who received on-demand therapy were included in the analysis.||infusions||Standard Deviation|Mean
664157|NCT01790828|Primary|Percentage of Participants by Family History of Factor VIII Inhibitor||4 years|All enrolled participants.||percentage of participants|||Number
664158|NCT01790750|Primary|False Negative Results of Pocket Echocardiography System (PES) Detection of Patent Ductus Arteriosus (PDA) to Full Featured Echo System (FFES)|Evaluate the usefulness of the currently FDA approved Pocket Echocardiography System (PES) in PDA detection as compared to Full Featured Echo System (FFES) by looking at false negatives between the two systems.|at baseline|||percentage of false negative||Standard Deviation|Mean
664159|NCT01790750|Primary|False Positives Results of Pocket Echocardiography System (PES) Detection of Patent Ductus Arteriosus (PDA) to Full Featured Echo System (FFES)|Evaluate the usefulness of the currently FDA approved Pocket Echocardiography System (PES) in PDA detection as compared to Full Featured Echo System (FFES) by looking at false positives between the two systems.|at baseline|||percentage of false positives||Standard Deviation|Mean
664160|NCT01790685|Primary|Number of Participants Who Had a >30% Decrease in the Aqueous Levels of Various Vasoactive Proteins 4 Weeks After an Injection of Ozurdex|Vasoactive protein arrays and Enzyme linked immunosorbent assays were done for patients at baseline and week 4 visit to measure the levels of various pro-permeability factors including VEGF, SDF-1 and Angiopoietin-2.|4 months|All enrolled (23 CRVO and 17 BRVO) patients completed the study. All patients were injected with Ozurdex, however microarrays were run on only 11 CRVO and 17 BRVO patient samples. Microarray data from 11 CRVO and 11 BRVO patients was analyzed.||participants|||Number
664168|NCT01790633|Other Pre-specified|Proportion of Rapid Test Failures|The number of rapid tests giving inconclusive results divided by the total number of rapid tests (only available in the rapid test arm).|At testing|Only patients randomized to the rapid testing arm.||proportion of participants|||Number
664169|NCT01790633|Other Pre-specified|Proportion Participating|The number of individuals accepting to participate in the study divided by the total number of individuals proposed.|At testing|||proportion of participants|||Number
664170|NCT01790633|Secondary|Access to Care|The number of individuals seeking specialized care with a complete evaluation of disease severity divided by the total number of seropositive individuals.|Evaluated once, up to 4 months after testing|Analysis includes only participants with positive HIV, HBV, and/or HCV results.||proportion of participants|||Number
664171|NCT01790633|Primary|Accessibility of Testing Results|The number of individuals who obtained test results for HBV, HCV, and/or HIV divided by the total number of tested individuals.|Evaluated once, up to 4 months after testing|||proportion of participants|||Number
664172|NCT01790581|Secondary|Self-assessed Disability|3 questionnaires regarding self-assessed disability during activities of daily living and sport will be completed. The questionnaires will include the Ankle Instability Instrument, the Foot and Ankle Ability Measure, and the Foot and Ankle Ability Measure-Sport.|Change from baseline disability at 1-month post intervention||||||
664173|NCT01790581|Secondary|Self-assessed Disability|2 questionnaires regarding self-assessed disability during activities of daily living and sport will be completed. The questionnaires will include the Foot and Ankle Ability Measure, and the Foot and Ankle Ability Measure-Sport.|Change from baseline disability at 1-week post intervention||||||
664174|NCT01790581|Primary|Self-assessed Disability|2 questionnaires regarding self-assessed disability during activities of daily living and sport will be completed. The questionnaires will include the Foot and Ankle Ability Measure, and the Foot and Ankle Ability Measure-Sport. The FAAM contains 21 activity related items (max score of 84) while the FAAM-S contains 8 activity related items (max score of 32). Lower percentages (patient’s score divided by max score) represent greater disability, and both FAAM and FAAM-S scores have been found to be reliable and precise (r=0.89, SEM= 2.1 and r=0.87, SEM= 4.5, respectively) in people with CAI.|Disability to 1-day post intervention|||% of total questionnaire points||Standard Deviation|Mean
664175|NCT01790581|Secondary|Balance|Dynamic balance will be assessed with the Star Excursion Balance Test (SEBT). This test requires a person to maintain their balance on a single limb while reaching as far as they can (with their other leg) in 3 different directions (forward, back-left, and back-right).|Change from baseline balance at 1-week post intervention||||||
664176|NCT01790581|Primary|Balance|Dynamic balance will be assessed with the Star Excursion Balance Test (SEBT). This test requires a person to maintain their balance on a single limb while reaching as far as they can (with their other leg) in 3 different directions (forward, back-left, and back-right).|Balance at 1-day post intervention|||% of leg length||Standard Deviation|Mean
664177|NCT01790516|Primary|Feasibility of Returning Genetic Testing Results in a Timely Manner to the Treating Physician|"Feasibility is defined as follows:
- Patients' genetic test results are returned to the treating physician within 3 days"|20 months|||days||Full Range|Median
664178|NCT01790490|Other Pre-specified|Cocaine Use in Follow-up|Weekly assessment of cocaine use by urine toxicology and history|4-week follow up||||||
664179|NCT01790490|Other Pre-specified|Change in Physiological Reactivity|Assesses level of physiological arousal to cues using galvanic skin response|change across infusions over 9 days||||||
664180|NCT01790490|Secondary|Risk of Initiating Experimental Drug Misuse|Weekly assessment of drug use by history and urine toxicology|4 week follow-up after completion of inpatient phase||||||
664181|NCT01790490|Secondary|Acute Tolerability|Various measures ascertain level of dissociation, abuse liability, and behavioral disturbances.|immediately after each infusion over 5 days||||||
664182|NCT01790490|Primary|Change in Motivation to Quit|Motivation score obtained from the University of Rhode Island Change Assessment (URICA). Scores are obtained at baseline and at 24 hours after each infusion. The scores are 0-13, with higher scores indicating greater motivation. The analysis is within-subject. Scores included below are means; higher scores represent higher motivation to quit than do lower scores.|Baseline and 24 hours post-infusion|||units on a scale||Full Range|Mean
664183|NCT01790490|Primary|Change in Cue Reactivity|Serial visual analogue scale (VAS) scores for craving elicited by cocaine cue: units on a scale (0-200), high is worse. Scores are obtained at baseline and at 24 hours after the infusion.|Baseline and 24 hours after infusion|||units on a scale (0-200), high is worse||Standard Error|Median
664184|NCT01790178|Secondary|Number of Participants With Inadequate Biopsy Samples|The presence of an inadequate sample was determined by the blinded pathologist reading the muscle biopsies. This reflects the sample having enough preserved muscle tissue for histologic analysis. It is separate from the number of participants receiving a diagnosis. A sample may be adequate, but non-diagnostic. Only one biopsy was performed in each patients, so the number of biopsies is the same as the number of participants.|At time of pathology review|||Inadequate Biopsy Samples|||Number
664185|NCT01790178|Secondary|Number of Times Biopsy Needle Was Inserted to Obtain Biopsy Tissue|"For core or needle biopsies, the physician passes the needle into the muscle until they feel that adequate tissue samples have been obtained. This outcome measure is the number of passes required in each study arm."|At time of biopsy|||needle passes||Standard Deviation|Mean
664186|NCT01790178|Secondary|Number of Participants With Adverse Events Related to Muscle Biopsy|Data will be examined to determine if ultrasound guidance reduces the rate of adverse events in muscle biopsies.|Patient involvement limited to the time of biopsy; Records analyzed up to 10 months after biopsy|||participants|||Number
664187|NCT01790178|Primary|Number of Patients Receiving Diagnosis From Muscle Biopsy|The rate of achieving a specific final diagnosis in ultrasound guided muscle biopsies vs. unguided biopsies will be examined.|At time of biopsy|||participants|||Number
664188|NCT01790178|Primary|Amount of Tissue Obtained|This data will be analyzed to determine if ultrasound guidance improves muscle yield (as measured by pathology determined volume and mass).|At time of biopsy|||grams||Standard Deviation|Mean
664189|NCT01789970|Secondary|Participants With Potentially Clinically Significant Abnormal Electrocardiogram Findings During the Double-Blind Treatment Period|Data represents the number of participants with potentially clinically significant (PCS) electrocardiogram findings on the final study visit.|Final study visit (week 12 or end of treatment visit)|Full analysis set||Participants|||Count of Participants
664190|NCT01789970|Secondary|Participants With Potentially Clinically Significant Abnormal Vital Sign Values During the Double-Blind Treatment Period|"Data represents participants with potentially clinically significant (PCS) vital sign values.
Significance criteria
Pulse - high: >=120 and increase of >= 15 beats/minute from baseline
Pulse - low: <=50 and decrease of >=15 beats/minute
Systolic blood pressure - high: >=180 and increase >=20 mmHg
Systolic blood pressure - low: <=90 and decrease >=20 mmHg
Diastolic blood pressure - high: >=105 and increase of >=15 mmHg
Diastolic blood pressure - low: <=50 and decrease of >=15 mmHg"|Day 1 to Week 12 of the Treatment Period|Full analysis set||Participants|||Count of Participants
664191|NCT01789970|Secondary|Participants With Potentially Clinically Significant Abnormal Laboratory Values During the Double-Blind Treatment Period|"Data represents participants with potentially clinically significant abnormal serum chemistry, hematology and urinalysis values.
Significance criteria:
Blood urea nitrogen: >=10.71 mmol/L
Creatinine: >=177 μmol/L
Uric acid: M>=625, F>=506 μmol/L
Alanine aminotransferase (ALT): >=3* upper limit of normal (ULN)
Gamma-glutamyl transpeptidase (GGT): >=3* upper limit of normal (ULN)
Serum white blood cells: <=3.0 * 10^9/L
Hemoglobin: M<=115, F<=95 g/dL
Hematocrit: M<0.37, F<0.32 L/L
Eosinophils: >=10.0 %
Absolute neutrophils: <=1.0 * 10^9/L
Urinalysis: Glucose: >=2 unit increase from baseline"|Day 1 up to Week 12 of the Treatment Period|Full analysis set including participants with laboratory assessments. Participants with a postbaseline result for that test are counted in each laboratory tests' label.||Participants|||Count of Participants
664192|NCT01789970|Secondary|Clinical Opiate Withdrawal Scales (COWS) Total Scores During the Double-Blind Treatment Period|"COWS is a clinician-rated scale used to measure a participant's signs and symptoms of withdrawal from opiates, with ratings based only on apparent relationship to withdrawal. The COWS was performed at weeks 1, 2, 4, and 12 (double blind treatment period) or early termination. The scale contained 11 signs/symptoms whose intensity the clinician rated on a scale of 0 to 4 or 5.
A total score was calculated as the sum of the responses to the 11 signs/symptoms for a total range of 0-48. Withdrawal severity was classified, based on the total score, as follows:
0 to 4=normal
5 to 12=mild
13 to 24=moderate
25 to 36=moderately severe
36=severe"|Weeks 1, 2, 4 and Endpoint of the Treatment Period|Full analysis set. Participants contributing to each time point are listed in the time point label.||units on a scale||Standard Deviation|Mean
664193|NCT01789970|Secondary|Subjective Opiate Withdrawal Scales (SOWS) Total Scores During the Double-Blind Treatment Period|The results of the SOWS were collected in the e-diary daily during the first 4 weeks of the double blind treatment period and then during clinic visits at week 12 or early termination. The SOWS was a self-administered questionnaire used to measure a participant's signs and symptoms of withdrawal from opiates. The scale contained 16 symptoms (such as my nose is running; I feel restless), the participant rated the intensity on a scale of 0 (not at all) to 4 (extremely) for a total score of 0-64. The daily total score for the first 4 weeks was the largest score observed during the time period preceding that visit. For example, the week 1 score for each participant was the largest total score on any day between baseline and the night before the week 1 visit; the week 4 score for each participant was the largest score observed between the week 2 visit and the night before the week 4 visit.|Weeks 1, 2, 4 and Endpoint of the Treatment Period|Full analysis set. Participants contributing to each time point are listed in the time point label.||units on a scale||Standard Deviation|Mean
664194|NCT01789970|Secondary|Participants With Clinically Significant Hearing Changes From Baseline to Final Assessment in Pure Tone Audiometry Test Results|Pure tone audiometry was performed by a qualified audiologist and was not done at the study center. During the test, the patient wore headphones and was seated in a quiet room; trained personnel manipulated the audiometry equipment to test the patient’s hearing. For serial audiograms, the criteria for a clinically significant (CS) hearing change were based on the guidance from the American Speech-Language Hearing Association (ASHA) 1994 (Konrad-Martin et al 2005). These criteria included the following: greater than 20 decibels (dB) pure tone threshold shift at 1 frequency; greater than 10 dB shift at 2 consecutive test frequencies; or threshold response shifting to “no response” at 3 consecutive test frequencies.|Days 7-14 of Titration Period (baseline), Day 0 of Treatment Period (last day of Titration Period), Week 12 or end of study visit during the Treatment Period|Safety analysis set (entire study), Full analysis set (treatment period)||Participants|||Count of Participants
664202|NCT01789606|Secondary|Maximum Daily Dose of Study Medication||Day 1 up to Day 30|This outcome measure was not planned to be analysed in self-selection arm. Analysis population included all participants of compliance arm who received at least 1 dose of the study drug during the 30 days and returned the completed study diary, or any information on dosing which was available.||milligram||Standard Deviation|Mean
664203|NCT01789606|Secondary|Average Daily Dose of Study Medication||Day 1 up to Day 30|This outcome measure was not planned to be analysed in self-selection arm. Analysis population included all participants of compliance arm who received at least 1 dose of the study drug during the 30 days and returned the completed study diary, or any information on dosing which was available.||milligram||Standard Deviation|Mean
664195|NCT01789970|Secondary|Participants With Adverse Events During Open-Label Titration and Double-Blind Treatment Periods|An adverse event (AE) was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an inability to carry out usual activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 of Titration Period up to Week 12 of Treatment Period (maximum treatment duration was 127 days)|Safety analysis set (Titration Period) and Full analysis set (Treatment Period)||Participants|||Count of Participants
664196|NCT01789970|Secondary|Change From Baseline to Final On-Treatment Visit in Roland Morris Disability Questionnaire (RMDQ) Score|The RMDQ is a patient-rated, 24-question evaluation used to assess acute disability associated with low back pain. Each question is answered with a YES or NO response, and each YES response is given 1 point. Scores on the RMDQ range from 0 to 24, with higher scores indicating greater disability. Negative change from baseline scores indicate improvement in level of disability.|Days 7-14 of Titration Period (baseline), Week 12 or end of study visit during the Treatment Period|Full analysis set, including participants with RMDQ score for the final on-treatment visit.||units on a scale||Standard Deviation|Mean
664197|NCT01789970|Secondary|Percentage of Participants With a 30% or Greater Increase in Weekly Average Pain Intensity (API) From Baseline to Week 12 Visit, and an Average API Score of 5 or Higher at Week 12|The API over the last 24 hours was recorded daily by participants in an electronic diary using an 11-point numerical rating scale (NRS-11), a Likert-type scale in which 0=no pain and 10=the worst pain imaginable. Participants selected the number that best described the average pain intensity over the last 24 hours. Weekly API scores averaged daily scores collected over the previous 7 days for each analysis visit.|Days -6 to 0 of Treatment Period (baseline), Week 12|Full analysis set, including participants with observed weekly average API for week 12||percentage of participants|||Number
664198|NCT01789970|Secondary|Kaplan-Meier Estimates for Time to Loss of Efficacy|Time to loss of efficacy was defined as discontinuation of study drug for lack of efficacy or the start of excessive rescue medication while taking study drug. Excessive rescue medication usage was defined as 10 or more days of rescue medication usage in any 14 consecutive days at a total of 15 mg (hydrocodone-equivalent) or higher each day during the post 2-week tapering period of the double-blind treatment period.|Day 1 to Week 12 of Treatment Period|The full analysis set, which includes all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline efficacy observation.||days||95% Confidence Interval|Median
664199|NCT01789970|Secondary|Change From Baseline to Week 12 of the Treatment Period in Weekly Average Pain Intensity (API)|"The API over the last 24 hours was recorded daily by patients in an electronic diary using an 11-point numerical rating scale (NRS-11), a Likert-type scale in which 0=no pain and 10=the worst pain imaginable. Participants selected the number that best described the average pain intensity over the last 24 hours. Weekly API scores averaged daily scores collected over the previous 7 days for each analysis visit. Negative change from baseline scores indicate improvement in pain control.
The analysis included API data observed before discontinuation of study drug and was based on the MI method to handle missing scores at week 12. Consistent with the recommendations of the National Academy of Sciences (NAS) report (Panel on Handling Missing Data in Clinical Trials 2010), the MI method includes an assumption of missing at random (MAR) and takes into account a potential bias toward the active-drug treatment group for patients who discontinued study drug because of adverse events."|Days -6 to 0 of Treatment Period (baseline), Week 12|The full analysis set, which includes all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline efficacy observation.||units on a scale||Standard Error|Mean
664200|NCT01789970|Primary|Change From Baseline to Week 12 of the Treatment Period in Weekly Average of Daily Worst Pain Intensity (WPI)|"The WPI was recorded daily by participants in an electronic diary using an 11-point numerical rating scale (NRS-11), a Likert-type scale in which 0=no pain and 10=the worst pain imaginable. Participants selected the number that best described their worst pain intensity over the last 24 hours. Weekly WPI scores averaged daily scores collected over the previous 7 days for each analysis visit. Negative change from baseline scores indicate improvement in pain control.
The analysis included WPI data observed before discontinuation of study drug and was based on the multiple imputations (MI) method to handle missing scores at week 12. Consistent with the recommendations of the National Academy of Sciences (NAS) report (Panel on Handling Missing Data in Clinical Trials 2010), the MI method includes an assumption of missing at random (MAR) and takes into account a potential bias toward the active-drug treatment group for patients who discontinued study drug because of adverse events."|Days -6 to 0 of Treatment Period (baseline), Week 12 of Treatment Period|The full analysis set, which includes all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline efficacy observation.||units on a scale||Standard Error|Mean
664201|NCT01789814|Primary|Change From Baseline in ADP-mediated Platelet Aggregation, APP, SFFLRN, AYPGKF.|"To document the extent of inhibition of ADP mediated platelet aggregation following the discontinuation of bivalirudin therapy in patients treated with prasugrel as compared to patients treated with clopidogrel.
The percent inhibition of platelet aggregation was measured by light transmission aggregometry of platelet-rich plasma in response to P2Y12 and PAR1 and PAR4 thrombin receptor agonists at baseline and at 1, 2, 4 and 16 h following the cessation of bivalirudin infusion. Platelet response to agonists: 20 mM ADP(P2Y12), 5 mM SFLLRN (PAR1), and 160 mM AYPGKF (PAR4) was performed. The magnitude of inhibition of platelet aggregation for each agonist was calculated as the mean final change from baseline in light transmission aggregometry at each time point."|Baseline, 60, 120, 240, 960 mins following termination of bivalirudin infusion|24 patients referred for intervention with planned bivalirudin therapy, not previously treated with a P2Y12 inhibitor and not receiving heparins or GP IIb/IIIa inhibitors were randomized to treatment with either clopidogrel (600 mg) or prasugrel (60 mg).||% inhibitn of platelet aggregation|||Number
664252|NCT01788215|Secondary|Total Number of Ovulations|The total number of ovulations per group. Ovulation was defined as elevation of serum progesterone and or urinary pregnanediol glucuronide followed by documented menstrual bleeding within 2 weeks of elevation.|week 24|In the sugar pill arm, one participant withdrew at week 12.||ovulations|||Number
664204|NCT01789606|Secondary|Number of Dosing Occasions Exceeding the Single Dose of 600 Milligram Excluding Treatment of Severe Symptoms|In this outcome measure, number of dosing occasions exceeding the single dose of 600 mg, excluding the events when severe symptoms were treated, were reported.|Day 1 up to Day 30|This outcome measure was not planned to be analysed in self-selection arm. Analysis population included all participants of compliance arm who received at least 1 dose of the study drug during the 30 days and returned the completed study diary, or any information on dosing which was available.||dosing occasions||Standard Deviation|Mean
664205|NCT01789606|Secondary|Number of Dosing Occasions Exceeding the Single Dose of 600 Milligram|In this outcome measure, number of dosing occasions exceeding the single dose of 600 mg were reported.|Day 1 up to Day 30|This outcome measure was not planned to be analysed in self-selection arm. Analysis population included all participants of compliance arm who received at least 1 dose of the study drug during the 30 days and returned the completed study diary, or any information on dosing which was available.||dosing occasions||Standard Deviation|Mean
664206|NCT01789606|Secondary|Number of Treatment Days Exceeding the Daily Dose of 1200 Milligram Excluding Treatment of Severe Symptoms|In this outcome measure, number of treatment days exceeding the daily dose of 1200 mg, excluding the days when severe symptoms were treated, were reported.|Day 1 up to Day 30|This outcome measure was not planned to be analysed in self-selection arm. Analysis population included all participants of compliance arm who received at least 1 dose of the study drug during the 30 days and returned the completed study diary, or any information on dosing which was available.||days||Standard Deviation|Mean
664207|NCT01789606|Secondary|Number of Treatment Days Exceeding the Daily Dose of 1200 Milligram|Number of treatment days when participants exceeded the daily dose of 1200 milligram were reported in this outcome measure.|Day 1 up to Day 30|This outcome measure was not planned to be analysed in self-selection arm. Analysis population included all participants of compliance arm who received at least 1 dose of the study drug during the 30 days and returned the completed study diary, or any information on dosing which was available.||days||Standard Deviation|Mean
664208|NCT01789606|Secondary|Number of Pain Episodes Treated With Single Dose or Multiple Dose Among Inappropriate Users|In this outcome measure, number of pain episodes treated with single dose or multiple dose per day among inappropriate users were reported. Participants were considered as inappropriate users if they improperly used the study medication in their last pain episode duration of <6 hours, based on the information provided at the follow up interview.|Day 1 up to Day 30|This outcome measure was not planned to be analysed in self-selection arm. Analysis population included all participants of compliance arm who received at least 1 dose of the study drug during the 30 days and returned the completed study diary, or any information on dosing which was available. ‘N’ is participants evaluable for this outcome measure.||pain episodes||Standard Deviation|Mean
664209|NCT01789606|Secondary|Number of Dosing Days Among Inappropriate Users|Participants were considered as inappropriate users if they improperly used the study medication in their last pain episode duration of <6 hours, if left untreated, based on the information provided at the follow up interview.|Day 1 up to Day 30|This outcome measure was not planned to be analysed in self-selection arm. Analysis population included all participants of compliance arm who received at least 1 dose of the study drug during the 30 days and returned the completed study diary, or any information on dosing which was available. ‘N’ is participants evaluable for this outcome measure.||days||Standard Deviation|Mean
664210|NCT01789606|Secondary|Average Daily Dose Among Excessive Users|Excessive users included all participants who used the study medication for more than 10 days (not necessarily consecutive) during study period with an average daily dose of >1600 mg or all participants who used the study medication for <=10 days during study period, used more than 20 tablets and had an average daily dose of >1600 mg.|Day 1 up to Day 30|This outcome measure was not planned to be analysed in self-selection arm. Analysis population included all participants of compliance arm who received at least 1 dose of the study drug during the 30 days and returned the completed study diary, or any information on dosing which was available. ‘N’ is participants evaluable for this outcome measure.||milligram||Standard Deviation|Mean
664211|NCT01789606|Primary|Percentage of Participants With the Use of Study Medication For Less Than or Equal to (<=) 10 Days and Use More Than 20 Tablets With an Average Daily Dose of Greater Than (>) 1600 mg|Percentage of participants who used the study medication for <=10 days and used more than 20 tablets with an average daily dose of >1600 mg were reported in this outcome measure.|Day 1 up to Day 30|This outcome measure was not planned to be analysed in self-selection arm. Analysis population included all participants of compliance arm who received at least 1 dose of the study drug during the 30 days and returned the completed study diary, or any information on dosing which was available.||percentage of participants||95% Confidence Interval|Number
664212|NCT01789606|Primary|Percentage of Participants With the Use of Study Medication For Greater Than (>) 10 Days With an Average Daily Dose of Greater Than (>) 1600 mg|Percentage of participants with the use of study medication for >10 days with an average daily dose of >1600 mg were reported in this outcome measure.|Day 1 up to Day 30|This outcome measure was not planned to be analysed in self-selection arm. Analysis population included all participants of compliance arm who received at least 1 dose of the study drug during the 30 days and returned the completed study diary, or any information on dosing which was available.||percentage of participants||95% Confidence Interval|Number
664213|NCT01789606|Primary|Percentage of Participants Who Select to Use Ibuprofen 200 mg IR Medication With a Typical Pain Duration of Greater Than or Equal to (>=) 6 Hours|Percentage of participants with selection of Ibuprofen 200 mg IR medication with a typical duration of pain >=6 hours were reported in this outcome measure. These participants were classified as ''missed opportunity'' cases.|Day 1|This outcome measure was not planned to be analysed in compliance arm. Analysis population included all participants enrolled in the self-selection arm of the study and completed the self-selection questionnaire. Here, 'N' signifies participants evaluable for this outcome measure.||percentage of participants||95% Confidence Interval|Number
664214|NCT01789606|Primary|Percentage of Participants Who Select to Use Ibuprofen 600 mg IR/ER Medication With a Typical Pain Duration of Less Than (<) 6 Hours|Percentage of participants with correct selection of Ibuprofen 600 mg IR/ER medication with a typical duration of pain <6 hours were reported in this outcome measure.|Day 1|This outcome measure was not planned to be analysed in compliance arm. Analysis population included all participants enrolled in the self-selection arm of the study and completed the self-selection questionnaire. Here, 'N' signifies participants evaluable for this outcome measure.||percentage of participants||95% Confidence Interval|Number
664215|NCT01789606|Primary|Percentage of Participants Who Correctly Select to Use or Correctly De-select Not to Use Ibuprofen 600 mg IR/ER Study Medication Excluding Those Classified as Missed Opportunity|Participants as correct selectors included all participants who selected Ibuprofen 600 mg IR/ER medication with the last episode of pain of >=6 hours, if left untreated. Participants as correct de-selectors included all participants who either selected Ibuprofen 200 mg or selected 'neither' with a typical pain duration of <6 hours, if left untreated. Participants were classified as “missed opportunity” cases when they selected the Ibuprofen 200 mg IR medication with their typical duration of pain >=6 hours.|Day 1|This outcome measure was not planned to be analysed in compliance arm. Analysis population included all participants enrolled in the self-selection arm of the study and completed the self-selection questionnaire. Here, 'Number of Participants Analyzed (N)' signifies participants evaluable for this outcome measure.||percentage of participants||95% Confidence Interval|Number
664216|NCT01789606|Primary|Percentage of Participants Who Correctly Select to Use or Correctly De-select Not to Use Ibuprofen 600 Milligram (mg) Immediate Release (IR) or Extended Release (ER) Study Medication|Participants as correct selectors included all participants who selected Ibuprofen 600 mg IR/ER medication with the last episode of pain of >=6 hours, if left untreated. Participants as correct de-selectors included all participants who either selected Ibuprofen 200 mg or selected 'neither' with a typical pain duration of less than (<) 6 hours, if left untreated.|Day 1|This outcome measure was not planned to be analysed in compliance arm. Analysis population included all participants enrolled in the self-selection arm of the study and completed the self-selection questionnaire.||percentage of participants||95% Confidence Interval|Number
664217|NCT01789476|Secondary|Summed Pain Intensity Differences Over 48 Hours (SPID 0-48) Following the Initial Administration of Study Drug|"Patients reported their pain intensity using a visual analogue scale (VAS) from 0 to 100 mm, where 0 mm represented No Pain and 100 mm represented the Worst Pain You Can Imagine. SPID 0-24 represents the cumulative time-weighted sum of the pain intensity difference (PID) scores between each assessment timepoint following the postoperative administration of study drug (i.e. 0 to 15 min, 15 to 30 min, etc.) over 24 hours. Pain intensity assessments were measured at baseline (entry pain score) and at 15, 30, 45, 60, 90, 120 and 150 minutes; 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 hours after the first administration of study drug.
Negative SPID values represent a decrease in pain intensity (i.e. lower values indicate a greater reduction in pain)."|Up to 48 hours|The analysis included all patients in the Completer population who completed the trial, where time 0 was the start time of the first dose of study drug.||units on a scale * hours||Standard Deviation|Mean
664218|NCT01789476|Secondary|Summed Pain Intensity Differences Over 36 Hours (SPID 0-36) Following the Initial Administration of Study Drug|"Patients reported their pain intensity using a visual analogue scale (VAS) from 0 to 100 mm, where 0 mm represented No Pain and 100 mm represented the Worst Pain You Can Imagine. SPID 0-24 represents the cumulative time-weighted sum of the pain intensity difference (PID) scores between each assessment timepoint following the postoperative administration of study drug (i.e. 0 to 15 min, 15 to 30 min, etc.) over 24 hours. Pain intensity assessments were measured at baseline (entry pain score) and at 15, 30, 45, 60, 90, 120 and 150 minutes; 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 hours after the first administration of study drug (only timepoints up to 36 hours used in calculating SPID 0-36).
Negative SPID values represent a decrease in pain intensity (i.e. lower values indicate a greater reduction in pain)."|Up to 36 hours|The analysis included all patients in the Completer population who completed the trial, where time 0 was the start time of the first dose of study drug.||units on a scale * hours||Standard Deviation|Mean
664219|NCT01789476|Primary|Summed Pain Intensity Differences Over 24 Hours (SPID 0-24) Following the Initial Administration of Study Drug|"Patients reported their pain intensity using a visual analogue scale (VAS) from 0 to 100 mm, where 0 mm represented No Pain and 100 mm represented the Worst Pain You Can Imagine. SPID 0-24 represents the cumulative time-weighted sum of the pain intensity difference (PID) scores between each assessment timepoint following the postoperative administration of study drug (i.e. 0 to 15 min, 15 to 30 min, etc.) over 24 hours. Pain intensity assessments were measured at baseline (entry pain score) and at 15, 30, 45, 60, 90, 120 and 150 minutes; 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 hours after the first administration of study drug (only timepoints up to 24 hours used in calculating SPID 0-24).
Negative SPID values represent a decrease in pain intensity (i.e. lower values indicate a greater reduction in pain)."|0 to 24 hours|The analysis included all patients in the Completer population who completed the trial, where time 0 was the start time of the first dose of study drug.||units on a scale * hours||Standard Deviation|Mean
664220|NCT01789255|Secondary|Plasma Concentrations of Inflammatory GVHD Markers|Summarized with means and 95% confidence intervals.|Up to day 100||||||
664221|NCT01789255|Secondary|Histone Acetylation in Peripheral Blood Stem Cells (PBMC)|Summarized with means and 95% confidence intervals.|Up to day 100||||||
664222|NCT01789255|Secondary|Relapse|Estimated with Kaplan-Meier methods.|Up to 1 year||||||
664223|NCT01789255|Secondary|Overall Survival|Estimated with Kaplan-Meier methods.|Up to 1 year||||||
664224|NCT01789255|Secondary|Steroid-free Survival|Estimated with Kaplan-Meier methods.|Up to 1 year||||||
664225|NCT01789255|Secondary|Mean Percent of Planned Dose Administered|The addition of vorinostat to tacrolimus and methotrexate for GVHD prophylaxis will be considered feasible if 60% or more of the planned doses are administered.|Up to day 30|||percent of dose administered||Full Range|Mean
664226|NCT01789255|Primary|The Number of Participants That Experience Grade 2-4 Acute GVHD (Graft Versus Host Disease) by Day 100|"The incidence of grade 2-4 acute GVHD (Graft Versus Host Disease) by day 100
Grade 2 GVHD: Maculopapular rash covering 25-50% of BSA (Body Surface Area), bilirubin between 3.1-6 mg/dl, and/ or adult stool output between 1000-1500 ml/day (child between 20-30 ml/kg/day).
Grade 3 GVHD: Maculopapular rash covering >50% of BSA, bilirubin between 6.1-15 mg/dl, and/ or adult stool output >1500 ml/day (child >30 ml/kg/day).
Grade 4 GVHD: Generalized erythroderma plus bullous formation and desquamation >5% BSA, bilirubin >15 mg/dl, and/ or severe abdominal pain with or without ileus, or grossly bloody stool."|Day 100|||participants|||Number
664227|NCT01789138|Secondary|HIV-1 RNA Count / Viral Load (VL)|Undetectable viral load: HIV-1 RNA <40 copies/mL|12 months|Number of participants who completed the 12-month study||participants|||Number
664228|NCT01789138|Primary|Antiretroviral Therapy (ART) Adherence (Self-reported 3-day Recall Measure)||12 months|Number of participants who completed the study||participants|||Number
664229|NCT01788566|Secondary|Number of Participants With Anti-Necitumumab Antibodies|A participant was considered to have an anti-necitumumab antibody response if anti-drug antibodies (ADA) were detected at any time point. Treatment emergent antibodies were defined as any anti-necitumumab antibody titer equal to or greater than 4-fold the participant's baseline titer.|Baseline up to 30 Days Post Last Infusion (up to 17 Months)|All participants who received any amount of study treatment and had evaluable baseline and postbaseline data for antibodies.||participants|||Number
664230|NCT01788566|Secondary|Pharmacokinetics (PK): Minimum (Cmin) Maximum Concentration (Cmax) of Necitumumab|Pre-infusion Minimum Concentration (Cmin) and post-infusion (Cmax) necitumumab serum concentration|Predose Cycle 1 Day 8; Cycle 2 through 6 Day 1; End of Infusion (EOI) Cycle 1, 3, 5 Day 1|All participants who received any amount of study treatment and had evaluable data for Cmax||micrograms/milliliter (ug/ml)||Geometric Coefficient of Variation|Geometric Mean
664231|NCT01788566|Secondary|Percent Change in Tumor Size (CTS)|CTS is defined as maximum percent improvement from baseline in the sum of target lesions.|Baseline until Measured Progressive Disease (up to 17 Months)|All participants who received any quantity of study treatment and had evaluable baseline and postbaseline data for CTS.||percent change||Standard Deviation|Mean
664232|NCT01788566|Secondary|Number of Participants Who Achieve Best Overall Disease Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD) [Disease Control Rate (DCR)]|DCR is best overall response of SD, PR or CR. According to RECIST v1.1, PR defined as a ≥30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD; CR was defined as the disappearance of all target and non-target lesions. SD was neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started. Percentage of participants who achieved disease control = (those participants counted in the denominator with a best tumor response of SD, PR, or CR)/(the same denominator as for ORR)*100.|Baseline to Measured Progressive Disease or Participants Stops Study (up to 17 Months)|All participants who received any quantity of study treatment and had evaluable baseline and postbaseline data for radiographic assessment.||percentage of participants||95% Confidence Interval|Number
664233|NCT01788566|Secondary|Progression Free Survival (PFS)|PFS is defined as the time from the date of first dose of study drug until objective progressive disease (PD) or death for any cause. According to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), PD was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the 20% relative increase, the sum must have also demonstrated an absolute increase of at least 5 millimeters (mm). The appearance of 1 or more new lesions was also considered progression. For participants not known to have died as of the data cut-off date and who do not have objective PD, PFS will be censored at the date of the last complete radiographic assessment.|Baseline to Measured Progressive Disease or Death from Any Cause (up to 17 Months)|All participants who received any quantity of study treatment.||months||95% Confidence Interval|Median
664234|NCT01788566|Secondary|Overall Survival (OS)|Overall survival (OS) duration is defined from the date of first dose of study drug to the date of death from any cause. OS was estimated by the Kaplan-Meier method. For participants who were not known to have died as of the data cut-off date, OS was censored at the date of last contact prior to the data cutoff date.|Baseline to Death from Any Cause (up to 17 Months)|All participants who received any amount of study treatment. Participants censored=34.||months||95% Confidence Interval|Median
664235|NCT01788566|Primary|Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) Objective Tumor Response Rate (ORR)|ORR is confirmed best overall tumor response of CR or PR. According to RECIST v1.1, PR defined as a >30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD; CR was defined as the disappearance of all target and non-target lesions. Percentage of participants was calculated as: total number of participants with a best tumor response of PR or CR among participants counted in the denominator/total number of participants treated with any amount of study drug, who has a complete radiographic assessment at baseline, and who has at least 1 complete radiographic assessment at postbaseline x 100%.|Baseline to Measured Progressive Disease (up to 17 Months)|All participants who received any amount of study treatment and had evaluable baseline and postbaseline data for radiographic assessment.||Percentage of participants||95% Confidence Interval|Number
664245|NCT01788228|Secondary|Assessment of Psychometric Validity and Internal Consistency of the Daily SF-36v2 Questionnaire||Day 0 to Day 7 for daily SF-36v2 questionnaires||12/2020||||
664246|NCT01788228|Secondary|Assessment of the Quality of Life Measures Overall and by Age Category (18-40; 41-64; 18-64; and >64 Years of Age) Via SF-36v2® Health Assessment Questionnaires||Day 0 and Day 7, Day 21 and Day 28 for weekly SF-36v2 questionnaires and Day 0 to Day 7 for daily SF-36v2 questionnaires||12/2020||||
664247|NCT01788228|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|A serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|During the entire study period (Day 0 to Day 385)|Analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.||Subjects|||Number
664248|NCT01788228|Secondary|Number of Subjects Reporting Any and Related Potential Immune-Mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) were defined as a subset of adverse events (AEs) that included autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Any was defined as occurrence of any pIMD regardless of intensity grade or relation to vaccination. Related was defined as pIMD(s) considered by the investigator to have a causal relationship to vaccination.|During the entire study period (Day 0 to Day 385)|Analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.||Subjects|||Number
664249|NCT01788228|Primary|Number of Subjects Reporting Any Unsolicited AEs, Overall and by Age Category (18-64 and >64 Years of Age)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 21-day (Days 0-20 post dose 1 and Days 21-41 post dose 2) post-vaccination period|Analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.||Subjects|||Number
664250|NCT01788228|Primary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Overall and by Age Category (18-64 and >64 Years of Age).|Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache, joint pain, muscle ache, shivering, sweating and fever [oral temperature above 38.5 degrees Celsius (°C)]. Gastrointestinal symptoms included nausea, vomiting, diarrhea and/or abdominal pain. Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature ≥ 39.0°C.|During a 7-day follow-up period (Days 0-6) after each vaccination|Analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.||Subjects|||Number
664251|NCT01788228|Primary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Overall and by Age Category (18-64 and >64 Years of Age).|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as significant pain at rest that prevented normal everyday activities. Grade 3 redness and swelling was greater than 100 millimeters (mm) i.e. >100mm.|During a 7-day follow-up period (Days 0-6) after each vaccination|Analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.||Subjects|||Number
664258|NCT01788215|Secondary|Serum Progesterone Levels in Blood|Serum progesterone levels will be obtained on a weekly basis to assess ovulation. We will then perform statistical analysis on this data to determine the effectiveness of doxycycline in this study population.|24 weeks|This measurement was not completed, because the number of ovulations was measured in its place and better indicates the effect of the treatment. See outcome measure number 8.|||||
664259|NCT01788215|Primary|Total Serum Testosterone|We will determine total serum testosterone levels in all participating subjects at week 24.|24 weeks|in the sugar pill arm one participant dropped out at week 12||ng/dL||Standard Deviation|Mean
664260|NCT01788163|Secondary|First Line Treatment Choice by Asia Pacific Country by Tumour EGFR Mutation Status||At Screening|Tumour Evaluable Population||Participants|||Number
664261|NCT01788163|Secondary|First Line Treatment Choice by Asia Pacific Country||At Screening|Tumour Evaluable Population||Participants|||Number
664262|NCT01788163|Secondary|Number of Organs With Metastasis by Plasma EGFR Mutation Status|Summary of number of organs with metastasis. Only participants with at least 1 organ with metastasis are included.|At Screening|Plasma Evaluable Population||Number||Standard Deviation|Mean
664263|NCT01788163|Secondary|Time Since First NSCLC Diagnosis by Plasma EGFR Mutation|Number of months since the first diagnosis of NSCLC from informed consent date.|At Screening|Plasma Evaluable Population||Months||Standard Deviation|Mean
664264|NCT01788163|Secondary|Demographics and Disease Characteristics by Plasma EGFR Mutation Status|Correlation of demographic and disease characteristics are summarized by EGFR mutation status with results from a multivariate logistic regression using stepwise forward selection with a 10% significance level for model entry.|At Screening|Plasma Evaluable Population||Participants|||Number
664265|NCT01788163|Secondary|Number of Organs With Metastasis by Tumour EGFR Mutation Status|Summary of number of organs with metastasis. Only participants with at least 1 organ with metastasis are included.|At Screening|Tumour Evaluable Population||Number||Standard Deviation|Mean
664266|NCT01788163|Secondary|Time Since First Non-small-cell Lung Carcinoma (NSCLC) Diagnosis by Tumor EGFR Mutation|Number of months since the first diagnosis of NSCLC from informed consent date.|At Screening|Tumour Evaluable Population||Months||Standard Deviation|Mean
664267|NCT01788163|Secondary|Demographics and Disease Characteristics by Tumour EGFR Mutation Status|Correlation of demographic and disease characteristics are summarized by EGFR mutation status with results from a multivariate logistic regression using stepwise forward selection with a 10% significance level for model entry.|At Screening|Tumour Evaluable Population||Participants|||Number
664268|NCT01788163|Secondary|Plasma EGFR Mutation Testing Turnaround Time|Plasma samples were only performed in China, Taiwan, South Korea and Russia. Plasma EGFR mutation testing turnaround time is the number of days from the test request to getting the test result.|At Screening|Enrolled Population||Time (Days)||Standard Deviation|Mean
664269|NCT01788163|Secondary|Plasma EGFR Mutation Testing Rates|Testing Success rate is the percentage of subjects with a non-missing test result. Mutation Detection Rate is the percentage of subjects with successful test that detects a mutation. Plasma samples were only performed in China, Taiwan, South Korea and Russia.|At Screening|Enrolled Population||Percentage of Participants|||Number
664270|NCT01788163|Secondary|Plasma EGFR Mutation Testing|Plasma samples were only performed in China, Taiwan, South Korea and Russia. Frequencies of plasma EGFR mutation testing practices parameters.|At Screening|Enrolled Population||Participants|||Number
664271|NCT01788163|Secondary|Tumour EGFR Mutation Testing Turnaround Time|Tumour EGFR mutation testing turnaround time is the number of days from the test request to getting the test result.|At Screening|Enrolled Population||Time (Days)||Standard Deviation|Mean
664272|NCT01788163|Secondary|Tumour EGFR Mutation Testing Rates|Testing Success rate is the percentage of subjects with a non-missing test result. Mutation Detection Rate is the percentage of subjects with successful test that detects a mutation.|At Screening|Enrolled Population||Percentage of Participants|||Number
664273|NCT01788163|Secondary|Tumour EGFR Mutation Testing|Frequencies of tumour EGFR mutation testing practices parameters.|At Screening|Enrolled Population||Participants|||Number
664274|NCT01788163|Secondary|Predictive Values of Comparison of Mutation Status Between Tumour and Plasma Samples|Plasma samples were only performed in China, Taiwan, South Korea, and Russia. Participants include only those who had Positive and Negative Predictive tests performed.|At Screening|Tumour and Plasma Evaluable Population||Percentage|||Number
664275|NCT01788163|Secondary|Sensitivity and Specificity of Comparison of Mutation Status Between Tumour and Plasma Samples|Plasma samples were only performed in China, Taiwan, South Korea, and Russia. Participants only include those who had sensitivity and specificity tests performed.|At Screening|Tumour and Plasma Evaluable Population||Percentage|||Number
664276|NCT01788163|Secondary|Concordance Rate of Comparison of Mutation Status Between Tumour and Plasma Samples|Plasma samples were only performed in China, Taiwan, South Korea and Russia.|At Screening|Tumour and Plasma Evaluable Population||Percentage|||Number
664277|NCT01788163|Primary|Plasma EGFR Mutation Status by Histology|Only subjects who had a recorded Histological Type of Adenocarcinoma or Non-adenocarcinoma are included. Confidence intervals were calculated using Clopper Pearson method for each country|At Screening|Plasma Evaluable Population||Percentage of participants||95% Confidence Interval|Number
664278|NCT01788163|Primary|Plasma EGFR Mutation by Subtype|Plasma samples were only performed in China, Taiwan, South Korea and Russia. Frequency distribution of subjects with a positive mutation status by the mutation subtype and country.|At Screening|Plasma Evaluable Population||Participants|||Number
664279|NCT01788163|Primary|Overall Plasma EGFR Mutation Status|Plasma samples were only performed in China, Taiwan, South Korea and Russia. The Confidence intervals were calculated using Clopper Pearson method for each country.|At Screening|Plasma Evaluable Population||Percentage of participants||95% Confidence Interval|Number
664280|NCT01788163|Primary|Tumour EGFR Mutation Status by Histology|Only subjects who had a recorded Histological Type of Adenocarcinoma or Non-adenocarcinoma are included. Confidence intervals were calculated using Clopper Pearson method for each country.|At Screening|Tumour Evaluable Population||Percentage of participants||95% Confidence Interval|Number
664281|NCT01788163|Primary|Tumour EGFR Mutation by Subtype|Frequency distribution of subjects with a positive mutation status by the mutation subtype and country.|At Screening|Tumour Evaluable Population||Participants|||Number
664283|NCT01788046|Secondary|Percent Change From Baseline in Predialysis Phosphorus During the Efficacy Assessment Phase||Baseline and the efficacy assessment phase (Week 20 to Week 27)|Full analysis set participants with observed data||percent change||Standard Error|Mean
664284|NCT01788046|Secondary|Percent Change From Baseline in Predialysis Corrected Calcium Phosphorus Product (cCa x P) During the Efficacy Assessment Phase||Baseline and the efficacy assessment phase (Week 20 to Week 27)|Full analysis set participants with observed data||percent change||Standard Error|Mean
664285|NCT01788046|Secondary|Percent Change From Baseline in Predialysis Corrected Calcium During the Efficacy Assessment Phase||Baseline and the efficacy assessment phase (Week 20 to Week 27)|Full analysis set participants with observed data||percent change||Standard Error|Mean
664286|NCT01788046|Secondary|Percent Change From Baseline in Predialysis PTH During the Efficacy Assessment Phase||Baseline and the Efficacy Assessment Phase (Week 20 to Week 27)|Full analysis set participants with observed data||percent change||Standard Error|Mean
664287|NCT01788046|Secondary|Percentage of Participants With Mean Predialysis Parathyroid Hormone ≤ 300 pg/mL During the Efficacy Assessment Phase|Participants who had no scheduled assessments during the EAP were considered non-responders.|Baseline and the efficacy assessment phase (Week 20 to Week 27)|Full analysis set||percentage of participants|||Number
664288|NCT01788046|Primary|Percentage of Participants With > 30% Decrease From Baseline in Mean PTH During the Efficacy Assessment Phase|Participants who did not have any scheduled assessments during the EAP were considered non-responders.|Baseline and the efficacy assessment phase (EAP; defined as Weeks 20 to 27, inclusive).|The full analysis set, consisting of all randomized participants||percentage of participants|||Number
664289|NCT01787838|Primary|Improving Pneumococcal Vaccination Rates Following Focused Health Education of Staff and Patients|Pneumococcal vaccination rates, tracked biweekly, following 1) staff education, audit and feedback of rates and 2) patient education|12 Months|||participants|||Number
664290|NCT01787825|Secondary|Preference Between CapsoCam SV-1 and PillCam SB2|Subject preference between CapsoCam SV-1 and PillCam SB2 based on pill preference questionnaire administered to subjects|Study Completion|For CapsoCam SV-1 and PillCam SB2 preference data was captured for 113 subjects.||participants|||Number
664291|NCT01787825|Secondary|Comparison of Diagnostic Yield of CapsoCam SV-1 as Compared to PillCam SB2|Comparison of Diagnostic Yield of CapsoCam SV-1 as compared to PillCam SB: Proportion of primary diagnostic yields based upon the result of 2 out of 3 readers in agreement or the consensus group result.|Study Completion|||participants|||Number
664292|NCT01787825|Secondary|Comparison of SB Transit Times With CapsoCam SV-1 and PillCam SB2|Total transit time, was determined the time the 1st Duodenal image to the 1st cecal or IC Valve image as determined by the readers.|Study Completion|For CapsoCam SV-1 data was captured for 112 subjects total transit time. For PillCam SB2, data was captured for 110 subjects for total transit time.||hours||Standard Deviation|Mean
664293|NCT01787825|Primary|Normal vs Abnormal, Overall Impression|The review of images of suspected diseased small bowel to determine agreement among readers between the two image capture systems: CapsoCam SV-1 and PillCam SB2. The proportion of Normal vs Abnormal, Overall Impression based upon the result of 2 out of 3 data readers in agreement.|Study Completion|Note: Each participant swallowed both Pill Cam and CapsoCam approximately 30-60 minutes apart. the order in which the cams were swalloed was randomized.||participants|||Number
664294|NCT01787799|Primary|In-stent Late Loss|In-stent late loss at 9 months post-procedure as measured by quantitative coronary angiography (QCA)|9 month|The primary endpoint would be considered to have been met if the SYNERGY in-stent late loss was less than the performance goal of 0.40 mm. The Intent To Treat (ITT) and per protocol populations were identical.||mm||95% Confidence Interval|Mean
664295|NCT01787760|Primary|Spherical Equivalent Refraction|Spherical Equivalent Refraction was computed from the sphero-cylindrical refraction measured with an open-field auto refractor. The median of 3 repeated measurements, each of which was the average of 3 consecutive readings, was used for the analysis. Higher values of spherical refraction indicate progression in Myopia.|Baseline and every 6 months post-baseline up to 3 years|Analysis was conducted on all randomized subjects who have at least one data point.||diopter (D)|Participants|Standard Deviation|Mean
664296|NCT01787760|Primary|Axial Length (Axial Elongation)|Axial Length was measured with the IOLMaster at baseline, and then every 6 months throughout the course of the study. Five measurements were collected for each eye at each visit and the average of the 5 measurements were used for the analysis. Higher values of axial elongation indicate worse vision.|Baseline and every 6 months post-baseline up to 3 years|Analysis was conducted on all randomized subjects who have at least one data point.||millimeter (mm)|Participants|Standard Deviation|Mean
664297|NCT01787591|Primary|Estimated Absorption (% Dose)|Absorption of deuterium labelled alpha-tocopherol|0-72 h post-meal|||% dose||Standard Error|Mean
664298|NCT01787591|Primary|Elimination Rate|Rate of plasma elimination of deuterium labelled alpha-tocopherol|0-72 h post-meal|||mmol/L/h||Standard Error|Mean
664299|NCT01787591|Primary|Tmax|Time to maximal plasma concentration of deuterium labelled alpha-tocopherol|0-72 h post-meal|||h||Standard Error|Mean
664300|NCT01787591|Primary|Cmax|Maximal plasma concentration of deuterium labelled alpha-tocopherol|0-72 h post-meal|||umol/L||Standard Error|Mean
664301|NCT01787591|Primary|Area Under the Curve 0-72 h (Deuterium Labeled Alpha-tocopherol)||0, 3, 6, 9, 12, 24, 36, 48, and 72 h post test meal|||umol/L x h||Standard Error|Mean
664302|NCT01787461|Secondary|Change From Baseline in Skin Density at Week 6, 12, 18 and 24 (With 100% Calibration Mode)|Skin density was measured using the DUB Cutis (taberna pro medicum), a high frequency and high resolution diagnostic ultrasound system with 100 percent (%) calibration mode. Measurements were taken on the left cheek, and the left inner and outer arm (up to 3 measurement).|Baseline, Week 6, 12, 18, 24|"m-ITT population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here n signifies those participants who were evaluable for this measure at specified time­ points for each arm, respectively."||micrometer||Standard Deviation|Mean
664303|NCT01787461|Secondary|Change From Baseline in Skin Thickness at Week 6, 12,18 and 24|Skin thickness was measured using the DUB Cutis (taberna pro medicum), a high frequency and high resolution diagnostic ultrasound system. Measurements were taken on the left cheek, and the left inner and outer arm (up to 3 measurement).|Baseline, Week 6, 12, 18, 24|"m-ITT population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here n signifies those participants who were evaluable for this measure at specified time ­points for each arm, respectively."||micrometer||Standard Deviation|Mean
664304|NCT01787461|Secondary|Change From Baseline in Trans-Epidermal Water Loss (TEWL) at Week 6, 12, 18 and 24|Trans-epidermal water loss (TEWL) measurements were done using DermaLab Combo SkinLab with a cylindrical diffusion chamber (10 mm [millimeter] diameter) containing 2 combined humidity/temperature sensors to determine the amount of water vapor that moves across the stratum corneum. TEWL measurements were taken on the left cheek and the left inner and outer arm (up to 3 measurement).|Baseline, Week 6, 12, 18, 24|"m-ITT population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here n signifies those participants who were evaluable for this measure at specified time­ points for each arm, respectively."||gram per square meter per hour||Standard Deviation|Mean
664305|NCT01787461|Secondary|Change From Baseline in Skin Hydration at Week 6, 12, 18 and 24|DermaLab Combo Skin Lab with an 8-pin probe was used to measure hydration (corneometry). Hydration measurements of the left cheek, left inner arm, and left outer arm were taken (up to 3 measurement).|Baseline, Week 6, 12, 18, 24|"m-ITT population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here n signifies those participants who were evaluable for this measure at specified time­ points for each arm, respectively."||microsecond||Standard Deviation|Mean
664306|NCT01787461|Secondary|Participant Improvement Assessment of Decolletage, Back of Hands and Body at Week 12 and 24|Participants performed the assessment of decolletage (decolletage overall, decolletage-wrinkling/crinkling (W/C), decolletage-discoloration (DD) and back of hands (back of hands overall, back of hands (BOH) - Fine lines/wrinkles (L/W), back of hands – discoloration) and Body – Dryness (BD) Overall at baseline using a 10-point numerical scale, and at Week 12, 24 using a 7-point improvement scale. At Baseline, participants rated the Decolletage, Back of Hands and Body parameters using a 10-point scale ranging from 1 (Not noticeable) to 10 (Very noticeable). At Week 12 and 24, assessment was performed relative to Baseline using an improvement scale that ranged from -3 to 3 (where -3 = Definite worsening, -2 = Moderate worsening, -1 = Slight worsening, 0 = No change, 1 = Slight improvement, 2 = Moderate improvement, 3 = Definite improvement).|Baseline, Week 12, 24|"m-ITT population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here n signifies those participants who were evaluable for this measure at specified time­ points for each arm, respectively."||units on scale||Standard Deviation|Mean
664307|NCT01787461|Secondary|Participants Improvement Assessment of Face at Week 12 and 24|Participants performed the assessment of face (overall facial (OA) appearance, fine lines and wrinkles (L/W) present in the eye area, upper lip, or cheek areas, under eye dark circles (dc) or bags, discoloration [uneven, patchy, blotchy areas of light and dark, age spots, liver spots], complexion/glow [bright radiant appearance] and smoothness) at Baseline using a 10-point numerical scale, and at Week 12, 24 using a 7-point improvement scale. At Baseline, participants rated the facial parameters using a 10-point scale ranging from 1 (Not noticeable) to 10 (Very noticeable). At Week 12 and 24, assessment was performed relative to Baseline using an improvement scale that ranged from -3 to 3 (where -3 = Definite worsening, -2 = Moderate worsening, -1 = Slight worsening, 0 = No change, 1 = Slight improvement, 2 = Moderate improvement, 3 = Definite improvement).|Baseline, Week 12, 24|"m-ITT population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here n signifies those participants who were evaluable for this measure at specified time­ points for each arm, respectively."||units on scale||Standard Deviation|Mean
664308|NCT01787461|Secondary|Change From Baseline in Investigator Assessment of Decolletage and Back of Hands at Weeks 12 and 24|Investigator performed the assessment of decolletage and back of hands (crepyness, mottled hyperpigmentation [MH]) using a numerical severity rating scale of 0 to 9 using 1/2 points, where 0 to less than or equal to (<=) 3 signifies Mild; greater than (>) 3 to <=6 signifies Moderate and >6 to <=9 signifies Severe.|Baseline, Week 12, 24|"Modified intent-to-treat (m-ITT) population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here n signifies those participants who were evaluable for this measure at specified time ­points for each arm, respectively."||units on scale||Standard Deviation|Mean
664309|NCT01787461|Secondary|Change From Baseline in Investigator Assessment of Face at Weeks 12 and 24|Investigator performed the assessment of face (Fine lines/wrinkles (L/W) of the periocular area (A), Fine lines/wrinkles of the perioral area, dark circles (dc) or “bags” under the eye, mottled hyperpigmentation (MH), sallowness/yellowing, roughness/texture) using a numerical severity rating scale of 0 to 9, where 0 to less than or equal to (<=) 3 signifies Mild; greater than (>) 3 to <=6 signifies Moderate and >6 to <=9 signifies Severe.|Baseline, Week 12, 24|"Modified intent-to-treat (m-ITT) population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here n signifies those participants who were evaluable for this measure at specified time­ points for each arm, respectively."||units on scale||Standard Deviation|Mean
664310|NCT01787461|Secondary|Change From Baseline in Investigator Global Assessment (IGA) of Participant's Overall Facial Appearance at Week 12|IGA of overall facial appearance was measured using a numerical severity rating scale of 0 to 9 using 1/2 points, where 0 to less than or equal to (<=) 3 signifies Mild; greater than (>) 3 to <=6 signifies Moderate and >6 to <=9 signifies Severe.|Baseline, Week 12|"m-ITT population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here n signifies those participants who were evaluable for this measure at specified time­ points for each arm, respectively."||units on scale||Standard Deviation|Mean
664311|NCT01787461|Secondary|Photographic Assessment Compared to Baseline of the Participants Overall Facial Appearance by Independent Panel Review Committee (IPRC) at Week 24|IPRC assessment was performed in accordance with the Canfield procedures and rated the improvement relative to Baseline. The investigators used an improvement scale that ranged from -3 to 3 (where -3 = Definite worsening, -2 = Moderate worsening, -1 = Slight worsening, 0 = No change, 1 = Slight improvement, 2 = Moderate improvement, 3 = Definite improvement).|Week 24|"m-ITT population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here N (number of participants analyzed) signifies those participants who were evaluable for this measure."||units on scale||Standard Deviation|Mean
664325|NCT01787279|Primary|Percentage of Participants Achieving Normalization of Alanine Aminotransferase at Week 72|Percentage of participants with a normal serum alanine aminotransferase (ALT) level at the end of the study was analyzed. Normal ranges for ALT are 7 to 56 International Units/Litre. Participants with ALT less than the upper limit of normal at end of treatment were reported.|At Week 72|ITT population included all the participants who received at least one dose of study medication and had one subsequent post baseline assessment.||Percentage of participants||95% Confidence Interval|Number
664312|NCT01787461|Primary|Change From Baseline in Investigator Global Assessment (IGA) of Participant's Overall Facial Appearance at Week 24|IGA of overall facial appearance was measured using a numerical severity rating scale of 0 to 9 using 1/2 points, where 0 to less than or equal to (<=) 3 signifies Mild; greater than (>) 3 to <=6 signifies Moderate and >6 to <=9 signifies Severe.|Baseline, Week 24|"Modified intent-to-treat (m-ITT) population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here n signifies those participants who were evaluable for this measure at specified time­ points for each arm, respectively."||units on scale||Standard Deviation|Mean
664313|NCT01787383|Secondary|Convenience TSQM|Convenience TSQM After a Treatment Cycle of 8 Weeks. Measurement of the perceived convenience with medication, ranging from 0 (worst possible outcome) to 100 (best possible outcome).|8 weeks|||units on a scale||Standard Deviation|Mean
664314|NCT01787383|Secondary|Global Satisfaction TSQM|Global Satisfaction TSQM After a Treatment Cycle of 8 Weeks. Measurement of the perceived overall satisfaction with medication, ranging from 0 (worst possible outcome) to 100 (best possible outcome).|8 weeks|||units on a scale||Standard Deviation|Mean
664315|NCT01787383|Secondary|Side Effects TSQM|Side Effects TSQM After a Treatment Cycle of 8 Weeks. Measurement of the perceived side effects of medication, ranging from 0 (worst possible outcome) to 100 (best possible outcome).|8 weeks|||units on a scale||Standard Deviation|Mean
664316|NCT01787383|Secondary|Effectiveness Satisfaction Questionnaire for Medication (TSQM)|Effectiveness TSQM After a Treatment Cycle of 8 Weeks. Measurement of the perceived effectiveness of medication, ranging from 0 (worst possible outcome) to 100 (best possible outcome).|8 weeks|||units on a scale||Standard Deviation|Mean
664317|NCT01787383|Secondary|Percent Reduction in Number of AKs in Each Separate Treatment Area 8 Weeks After Treatment|"Percent reduction in number of Actinic Keratosis lesions (AKs) analysed for each separate treatment area and presented by treatment regimen. Each subject could contribute with up to 2 values (1 for each treated area). Both affected areas were calculated together Per Arm (e.g. averaged)."|8 weeks after treatment|||percentage reduction in number of AKs||Standard Deviation|Mean
664318|NCT01787383|Secondary|Partial Clearance of AKs in Each Separate Treatment Area 8 Weeks After Treatment|"Partial clearance of Actinic Keratosis lesions (AKs) defined as 75% or greater reduction in Actinic Keratosis lesions (AKs) from start of treatment to 8 weeks after treatment, was analysed in each separate treatment area and presented by treatment regimen given as percentage of participatns with complete AK clearance. Each subject could contribute with up to 2 values (1 for each treated area). Both affected areas were calculated together Per Arm (e.g. averaged)."|8 weeks after treatment|||percentage of participants|||Number
664319|NCT01787383|Secondary|Complete Clearance of AKs in Each Separate Treatment Area 8 Weeks After Treatment|"Complete clearance of Actinic Keratosis lesions (AKs) analysed in each separate treatment area and presented by treatment regimen given as percentage of participants with complete AK clearance. Each subject could contribute with up to 2 values (1 for each treated area). Both affected areas were calculated together Per Arm (e.g. averaged)."|8 weeks after treatment|||percentage of participants|||Number
664320|NCT01787383|Primary|Composite Local Skin Reaction (LSR) Score 3 Days After Treatment of Each Selected Treatment Area|"Composite Local Skin Reaction (LSR) score 3 days after treatment of each selected treatment area in both treatment groups (simultaneous or sequential). The composite LSR score (0 to 24), reflecting the sum of the individual LSR grades (erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration, grade 0 to 4), was calculated for each selected treatment area at each visit.The composite LSR score ranges from 0 (best possible outcome) to 24 (worst possible outcome). Both affected areas were calculated together Per Arm. Each subject could contribute with up to 2 values (1 for each treated area)."|3 days after treatment of each selected treatment area|||units on a scale||Standard Deviation|Mean
664321|NCT01787279|Secondary|Percentage of Participants Achieving Combined Response Hepatitis B Virus DNA < 10,000 Copies/mL and Normal ALT at Week 72|Percentage of participants showing normal ALT values and HBV DNA levels <10,000 copies/ mL were reported.|At Week 72|ITT population included all the participants who received at least one dose of study medication and had one subsequent post baseline assessment. Participants available at the time of assessment were included in the analysis.||Percentage of participants|||Number
664322|NCT01787279|Secondary|Percentage of Participants Achieving Hepatitis B Surface Antigen Seroconversion at Screening and Week 48|Seroconversion is defined as the absence of hepatitis B surface antigen (HBsAg) with a negative result for HBsAg and the presence of anti-Haemoglobin (HBs) antibodies (a positive result for anti-HBs) determined at Week 48. Blood samples were analyzed to check whether it is HBsAg-negative and anti-HBs antibodies positive.|At Screening and Week 48|ITT population included all the participants who received at least one dose of study medication and had one subsequent post baseline assessment. ‘n’=number of evaluable participants available at specified time point.||Percentage of participants|||Number
664323|NCT01787279|Secondary|Percentage of Participants Achieving Hepatitis B Virus DNA < 400 Copies/mL at Week 72|Participants who had HBV-DNA levels below 400 Copies/mL at the end of follow-up (at Week 72) were reported.|At Week 72|ITT population included all the participants who received at least one dose of study medication and had one subsequent post baseline assessment.||Percentage of participants||95% Confidence Interval|Number
664324|NCT01787279|Primary|Number of Participants With Any Adverse Events and Serious Adverse Events|An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. A serious adverse event (SAE) is any significant hazard, contraindication, side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability/ incapacity, is a congenital anomaly/ birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above|Up to Week 72|Safety analysis population is defined to include only participants who receive at least one dose of study medication and have one subsequent post baseline safety assessment.||Participants|||Number
664629|NCT01783418|Primary|Changes in Mood From Baseline to Post-intervention and 6 Months Post-intervention|"Beck youth inventories - Depression scale
Subscale range: 0 (minimum score) - 60 (maximum score)
Higher scores a worse outcome"|baseline, Post-intervention (8 weeks)|||units on a scale||Standard Deviation|Mean
664326|NCT01787279|Primary|Percentage of Participants Achieving Hepatitis C Virus Deoxyribonucleic Acid <10,000 Copies/Milliliter at Week 72|Participants who had Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) levels below 100,000 copies per milliliter (mL) at the end of follow-up (at Week 72) were reported.|At Week 72|Intent-to-treat (ITT) population included all the participants who received at least one dose of study medication and had one subsequent post baseline assessment.||Percentage of participants||95% Confidence Interval|Number
664327|NCT01787240|Other Pre-specified|Effects of Acute Tryptophan Depletion on Serotonin Binding|"We will examine percentage changes in serotonin binding potential before and after acute tryptophan depletion within each region of interest. We will examine differences in serotonin binding potential between placebo responders and drug responders using a paired two-tailed t-test.
Data were not collected"|Visit 5 (after 4 weeks in study) or Visit 10 (after 9 weeks in study)|Data were not collected|||||
664328|NCT01787240|Secondary|Effects of Acute Tryptophan Depletion on Mood|"We will examine differences in scores on the the HAMD-28 before and after acute tryptophan depletion. Changes in these parameters will be compared between placebo responders and drug responders using unpaired two-tailed t-tests.
The HAMD-28 measures depression severity, and has a minimum value of 0 and a maximum value of 81 units on a scale, where higher scores indicate more severe depression.
A negative change value refers to a decrease in HAM D score."|Baseline, Visit 5 (4 weeks into study)|Patients who were randomized to take placebo or active drug||units on a scale||Standard Deviation|Mean
664329|NCT01787240|Secondary|Effects of Acute Tryptophan Depletion on Mood|"We will examine differences in scores on the the HAMD-28 before and after acute tryptophan depletion. Changes in these parameters will be compared between placebo responders and drug responders using unpaired two-tailed t-tests.
The HAMD-28 measures depression severity, and has a minimum value of 0 and a maximum value of 81 units on a scale, where higher scores indicate more severe depression.
A negative change value refers to a decrease in HAM D score."|Baseline, Visit 10 (after 9 weeks in study)|Participants assigned to take either active drug or placebo who did not respond by the end of phase 1 (Week 5 of study treatment) continued onto phase 2.||units on a scale||Standard Deviation|Mean
664330|NCT01787240|Primary|Feasibility|We will measure the percentage of screened eligible patients who agree to be randomized. Participants were assessed for this Outcome Measure before randomization.This would occur at the first study visit (screening).|This would occur at the first study visit (screening).|||percent of eligible patients|||Number
664331|NCT01787188|Secondary|Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Osteoarthritis Stiffness Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score.|"The stiffness in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) stiffness subscale score. The WOMAC stiffness subscale score is calculated as the mean of the visual analogue scale scores from 2 stiffness subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their stiffness level over the last 24 hours, with 0 mm meaning No Stiffness and 100 mm meaning Extreme Stiffness.
The WOMAC stiffness subscale score difference was calculated as the WOMAC stiffness subscale score assessed at Weeks 2, 6, and 12 minus the WOMAC stiffness subscale score assessed at baseline."|Baseline to Week 12/Early Termination|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.||mm||Standard Error|Least Squares Mean
664332|NCT01787188|Secondary|Change From Baseline to Week 12 After Trial Entry in Osteoarthritis Stiffness Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score.|"The stiffness in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) stiffness subscale score. The WOMAC stiffness subscale score is calculated as the mean of the visual analogue scale scores from 2 stiffness subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their stiffness level over the last 24 hours, with 0 mm meaning No Stiffness and 100 mm meaning Extreme Stiffness.
The WOMAC stiffness subscale score difference was calculated as the WOMAC stiffness subscale score assessed at Week 12/early termination minus the WOMAC stiffness subscale score assessed at baseline."|Baseline to Week 12/Early Termination|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.||mm||Standard Error|Least Squares Mean
664333|NCT01787188|Secondary|Change From Baseline to Week 6 After Trial Entry in Osteoarthritis Stiffness Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score.|"The stiffness in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) stiffness subscale score. The WOMAC stiffness subscale score is calculated as the mean of the visual analogue scale scores from 2 stiffness subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their stiffness level over the last 24 hours, with 0 mm meaning No Stiffness and 100 mm meaning Extreme Stiffness.
The WOMAC stiffness subscale score difference was calculated as the WOMAC stiffness subscale score assessed at Week 6 minus the WOMAC stiffness subscale score assessed at baseline."|Baseline to Week 6|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.||mm||Standard Error|Least Squares Mean
664334|NCT01787188|Secondary|Change From Baseline to Week 2 After Trial Entry in Osteoarthritis Stiffness Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score.|"The stiffness in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) stiffness subscale score. The WOMAC stiffness subscale score is calculated as the mean of the visual analogue scale scores from 2 stiffness subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their stiffness level over the last 24 hours, with 0 mm meaning No Stiffness and 100 mm meaning Extreme Stiffness.
The WOMAC stiffness subscale score difference was calculated as the WOMAC stiffness subscale score assessed at Week 2 minus the WOMAC stiffness subscale score assessed at baseline."|Baseline to Week 2|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.||mm||Standard Error|Least Squares Mean
666091|NCT01763827|Secondary|Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL||Weeks 10 and 12|Full analysis set||percentage of participants||95% Confidence Interval|Number
664335|NCT01787188|Secondary|Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Osteoarthritis Function Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Function Subscale Score.|"The function in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function subscale score. The WOMAC function subscale score is calculated as the mean of the visual analogue scale scores from 17 function subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their functional limitation level over the last 24 hours, with 0 mm meaning No Functional Limitation and 100 mm meaning Extreme Functional Limitation.
The WOMAC function subscale score difference was calculated as the WOMAC function subscale score assessed at Weeks 2, 6, and 12 minus the WOMAC function subscale score assessed at baseline."|Baseline to Week 12/Early Termination|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.||mm||Standard Error|Least Squares Mean
664336|NCT01787188|Secondary|Change From Baseline to Week 12 After Trial Entry in Osteoarthritis Function Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Function Subscale Score.|"The function in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function subscale score. The WOMAC function subscale score is calculated as the mean of the visual analogue scale scores from 17 function subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their functional limitation level over the last 24 hours, with 0 mm meaning No Functional Limitation and 100 mm meaning Extreme Functional Limitation.
The WOMAC function subscale score difference was calculated as the WOMAC function subscale score assessed at Week 12/early termination minus the WOMAC function subscale score assessed at baseline."|Baseline to Week 12/Early Termination|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.||mm||Standard Error|Least Squares Mean
664337|NCT01787188|Secondary|Change From Baseline to Week 6 After Trial Entry in Osteoarthritis Function Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Function Subscale Score.|"The function in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function subscale score. The WOMAC function subscale score is calculated as the mean of the visual analogue scale scores from 17 function subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their functional limitation level over the last 24 hours, with 0 mm meaning No Functional Limitation and 100 mm meaning Extreme Functional Limitation.
The WOMAC function subscale score difference was calculated as the WOMAC function subscale score assessed at Week 6 minus the WOMAC function subscale score assessed at baseline."|Baseline to Week 6|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.||mm||Standard Error|Least Squares Mean
664338|NCT01787188|Secondary|Change From Baseline to Week 2 After Trial Entry in Osteoarthritis Function Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Function Subscale Score.|"The function in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function subscale score. The WOMAC function subscale score is calculated as the mean of the visual analogue scale scores from 17 function subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their functional limitation level over the last 24 hours, with 0 mm meaning No Functional Limitation and 100 mm meaning Extreme Functional Limitation.
The WOMAC function subscale score difference was calculated as the WOMAC function subscale score assessed at Week 2 minus the WOMAC function subscale score assessed at baseline."|Baseline to Week 2|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.||mm||Standard Error|Least Squares Mean
664339|NCT01787188|Secondary|Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Osteoarthritis Pain, Stiffness, and Function Measured Using the Total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score.|"Pain, stiffness, and function in subjects with osteoarthritis were measured using the Western Ontario and McMaster Universities (WOMAC) Index, which is a 24-item questionnaire. The total (composite) WOMAC score is calculated as the average of the mean visual analogue scale (VAS) scores from the questions in the pain, stiffness, and function subscales. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their response to each of the questions, with 0 mm representing No Pain, Stiffness, or Difficulty and 100 mm representing Extreme Pain, Stiffness, and Difficulty.
The total WOMAC score difference was calculated as the total WOMAC score assessed at Weeks 2, 6, and 12 minus the total WOMAC score assessed at baseline."|Baseline to Week 12/Early Termination|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.||mm||Standard Error|Least Squares Mean
664340|NCT01787188|Secondary|Change From Baseline to Week 12 After Trial Entry in Osteoarthritis Pain, Stiffness, and Function Measured Using the Total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score.|"Pain, stiffness, and function in subjects with osteoarthritis were measured using the Western Ontario and McMaster Universities (WOMAC) Index, which is a 24-item questionnaire. The total WOMAC score is calculated as the average of the mean visual analogue scale (VAS) scores from the questions in the pain, stiffness, and function subscales. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their response to each of the questions, with 0 mm representing No Pain, Stiffness, or Difficulty and 100 mm representing Extreme Pain, Stiffness, and Difficulty.
The total WOMAC score difference was calculated as the total WOMAC score assessed at Week 12/early termination minus the total WOMAC score assessed at baseline."|Baseline to Week 12/Early Termination|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.||mm||Standard Error|Least Squares Mean
664357|NCT01786954|Secondary|Adverse Events|The secondary outcome is the onset of any adverse events related to measurement of intraocular pressure.|postoperative day #1|Adverse events were analyzed for all enrolled patients, in contrast to IOP measurements, which were only analyzed for the 50 post-vitrectomy patients.||adverse events|||Number
666092|NCT01763827|Secondary|Change From Baseline in LDL-C at Week 12||Baseline and Week 12|Full analysis set||mg/dL||Standard Error|Least Squares Mean
664341|NCT01787188|Secondary|Change From Baseline to Week 6 After Trial Entry in Osteoarthritis Pain, Stiffness, and Function Measured Using the Total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score.|"Pain, stiffness, and function in subjects with osteoarthritis were measured using the Western Ontario and McMaster Universities (WOMAC) Index, which is a 24-item questionnaire. The total WOMAC score is calculated as the average of the mean visual analogue scale (VAS) scores from the questions in the pain, stiffness, and function subscales. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their response to each of the questions, with 0 mm representing No Pain, Stiffness, or Difficulty and 100 mm representing Extreme Pain, Stiffness, and Difficulty.
The total WOMAC score difference was calculated as the total WOMAC score assessed at Week 6 minus the total WOMAC score assessed at baseline."|Baseline to Week 6|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.||mm||Standard Error|Least Squares Mean
664342|NCT01787188|Secondary|Change From Baseline to Week 2 After Trial Entry in Osteoarthritis Pain, Stiffness, and Function Measured Using the Total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score.|"Pain, stiffness, and function in subjects with osteoarthritis were measured using the Western Ontario and McMaster Universities (WOMAC) Index, which is a 24-item questionnaire. The total WOMAC score is calculated as the average of the mean visual analogue scale (VAS) scores from the questions in the pain, stiffness, and function subscales. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their response to each of the questions, with 0 mm representing No Pain, Stiffness, or Difficulty and 100 mm representing Extreme Pain, Stiffness, and Difficulty.
The total WOMAC score difference was calculated as the total WOMAC score assessed at Week 2 minus the total WOMAC score assessed at baseline."|Baseline to Week 2|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.||mm||Standard Error|Least Squares Mean
664343|NCT01787188|Secondary|Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.|"The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing No Pain and 100 mm representing Extreme Pain.
The WOMAC pain subscale score difference was calculated as the WOMAC pain subscale score assessed at Weeks 2, 6, and 12 minus the WOMAC pain subscale score assessed at baseline."|Baseline to Week 12/Early Termination|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.||mm||Standard Error|Least Squares Mean
664344|NCT01787188|Secondary|Change From Baseline to Week 6 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.|"The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing No Pain and 100 mm representing Extreme Pain.
The WOMAC pain subscale score difference was calculated as the WOMAC pain subscale score assessed at Week 6 minus the WOMAC pain subscale score assessed at baseline."|Baseline to Week 6|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.||mm||Standard Error|Least Squares Mean
664345|NCT01787188|Secondary|Change From Baseline to Week 2 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.|"The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing No Pain and 100 mm representing Extreme Pain.
The WOMAC pain subscale score difference was calculated as the WOMAC pain subscale score assessed at Week 2 minus the WOMAC pain subscale score assessed at baseline."|Baseline to Week 2|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.||mm||Standard Error|Least Squares Mean
664346|NCT01787188|Primary|Change From Baseline to Week 12 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.|"The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing No Pain and 100 mm representing Extreme Pain.
The WOMAC pain subscale score difference is calculated as the WOMAC pain subscale score assessed at Week 12 minus the WOMAC pain subscale score assessed at baseline."|Baseline to Week 12/Early Termination|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.||mm||Standard Error|Least Squares Mean
664347|NCT01787175|Secondary|Identification of Planned Monitoring and Follow up Encounters in Assessment and Plan|Each participant had 10 minutes maximum to review the patient case and write an Assessment and Plan. . The secondary outcome evaluated participants’ recommendation about future monitoring of patient conditions. Participants reviewed a total of 10 patient cases and received a score of 0 or 1 point for each issue within each case. The final score for each participant was a proportion between 0 and 1. The proportion represented the sum of all points assigned to the participant, divided by the total number of points possible. Higher values on the scale represent a greater proportion of appropriate monitoring recommendations made.|10 minutes|||proportion||95% Confidence Interval|Mean
666042|NCT01763905|Secondary|Percent Change From Baseline in the Total Cholesterol/High Density Lipoprotein Cholesterol Ratio at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
664348|NCT01787175|Primary|Accuracy of Written Assessment and Plan in Terms of Control and Status|Each participant had 10 minutes maximum to review the patient case and write an Assessment and Plan. The primary outcome evaluated participants’ recommendations for treatment of patient conditions. Participants reviewed a total of 10 patient cases and received a score between 0 and 3 points for each issue within each patient case. The final score for each participant was a proportion between 0 and 1. The proportion represented the sum of all points assigned to the participant, divided by the total number of points possible. Higher values on the scale represent greater accuracy of the written assessment and plan.|10 minutes|||units on a scale||95% Confidence Interval|Mean
664349|NCT01787175|Primary|Amount of Time to Complete Assessment and Plan|Each participant had 10 minutes maximum to review the patient case and write an Assessment and Plan.|10 minutes|58 providers were enrolled||minutes||Standard Deviation|Mean
664350|NCT01787032|Secondary|Terminal Half-life of BI 113608 in Plasma (t1/2)|This outcome measure presents terminal half-life of BI 113608 in plasma.|1 hour before drug administration and 0:25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 and 72 hours after drug administration.|Pharmacokinetic Set (PKS): The ‘PK set’ included all subjects of the treated set who provided at least one evaluable observation for at least one primary PK endpoint in at least one treatment period without important protocol violations relevant to the evaluation of PK; PK analyses were based on the PK set.||hours (h)||Geometric Coefficient of Variation|Geometric Mean
664351|NCT01787032|Secondary|Time From Dosing to Maximum Measured Concentration of BI 113608 in Plasma (Tmax)|This outcome measure presents time from dosing to maximum measured concentration of BI 113608 in plasma.|1 hour before drug administration and 0:25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 and 72 hours after drug administration.|Pharmacokinetic Set (PKS): The ‘PK set’ included all subjects of the treated set who provided at least one evaluable observation for at least one primary PK endpoint in at least one treatment period without important protocol violations relevant to the evaluation of PK; PK analyses were based on the PK set.||hours (h)||Geometric Coefficient of Variation|Geometric Mean
664352|NCT01787032|Secondary|Area Under the Concentration-time Curve of BI 113608 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)|"This outcome measure presents area under the concentration-time curve of BI 113608 in plasma over the time interval from 0 to infinity.
The parameter dispersion type (standard deviation) is actually intra individual geometric coefficient of variation (intraindividual gCV).
Statistical analysis 1: The ratio (Other) is calculated as BI + K (T1): BI (R) [%]. Statistical analysis 2: The ratio (Other) is calculated as BI + V (T2): BI (R) [%]."|1 hour before drug administration and 0:25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 and 72 hours after drug administration.|Pharmacokinetic Set (PKS): The ‘PK set’ included all subjects of the treated set who provided at least one evaluable observation for at least one primary PK endpoint in at least one treatment period without important protocol violations relevant to the evaluation of PK; PK analyses were based on the PK set.||nanomol*hours/litre (nmol*h/L)||Geometric Coefficient of Variation|Geometric Mean
664353|NCT01787032|Primary|Maximum Measured Concentration of BI 113608 in Plasma (Cmax)|"This outcome measure presents the maximum measured concentration of BI 113608 in plasma.
The parameter dispersion type (standard deviation) is actually intra individual geometric coefficient of variation (intraindividual gCV).
Statistical analysis 1: The ratio (Other) is calculated as BI + K (T1): BI (R) [%]. Statistical analysis 2: The ratio (Other) is calculated as BI + V (T2): BI (R) [%]."|1 hour before drug administration and 0:25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 and 72 hours after drug administration.|Pharmacokinetic Set (PKS): The ‘PK set’ included all subjects of the treated set who provided at least one evaluable observation for at least one primary PK endpoint in at least one treatment period without important protocol violations relevant to the evaluation of PK; PK analyses were based on the PK set.||nanomol/litre (nmol/L)||Geometric Coefficient of Variation|Geometric Mean
664354|NCT01787032|Primary|Area Under the Concentration-time Curve of BI 113608 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)|"This outcome measure presents the area under the concentration-time curve of BI 113608 in plasma over the time interval from 0 to the last quantifiable data point.
The parameter dispersion type (standard deviation) is actually intra individual geometric coefficient of variation (intraindividual gCV).
Statistical analysis 1: The ratio (Other) is calculated as BI+K (T1): BI (R) [%]. Statistical analysis 2: The ratio (Other) is calculated as BI + V (T2): BI (R) [%]."|1 hour before drug administration and 0:25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 and 72 hours after drug administration.|Pharmacokinetic Set (PKS): The ‘PK set’ included all subjects of the treated set who provided at least one evaluable observation for at least one primary PK endpoint in at least one treatment period without important protocol violations relevant to the evaluation of PK; PK analyses were based on the PK set.||nanomol*hours/litre (nmol*h/L)||Geometric Coefficient of Variation|Geometric Mean
664355|NCT01786993|Primary|Percentage of Non-responders With MPP Compared to Biventricular Pacing|"The hypothesis is that the non-response rate to CRT therapy in the MPP therapy arm is not inferior to the non-response rate in the BiV arm between 3 and 9 months post-implant. Responder status was assessed using the Clinical Composite Score (CCS). A patient’s CCS was classified as worsened, improved or unchanged based on the definitions below:
Worsened - patient died due to cardiovascular reasons, experienced a HF event, demonstrated worsening in NYHA class, or had worsening of PGA score compared to the last observation
Improved - patient survived without a HF event, and demonstrated either improvement in NYHA class or improvement in PGA score, or both compared to the last observation.
Unchanged - patient was neither improved nor worsened
For patients who were responders at the 3-month visit, those who were “Improved” and “Unchanged” between 3 and 9 months were classified as responders, whereas those who were “Worsened” were grouped together as non-responders."|3 months to 9 months|||percentage of patients|||Number
664356|NCT01786993|Primary|Freedom From System-related Complications Through 9 Months Compared to an Objective Performance Criterion|A system related complication is a complication related to the Quadripolar CRT-D device system which includes pulse generator and leads, as adjudicated by an independent Clinical Events Committee (CEC). All subjects who had an attempted implant or a successful Quadripolar system implant were included in the analysis of this safety endpoint.|Implant to 9 months|Of 469 subjects who underwent an attempted implant, 31 subjects experienced a system-related complication between implant and 9 months (13 were LV lead-related, 16 were RA/RV lead-related and 3 were Quadripolar CRT-D pulse generator related. One subject experienced more than one category of complication).||Event-Free Probability||95% Confidence Interval|Number
664358|NCT01786954|Primary|Measurement of Intraocular Pressure|The primary outcome is the measurement of intraocular pressure on postoperative day #1 following vitreoretinal surgery.|postoperative day #1|Of the 68 patients enrolled, only 50 patients who received IOP measurement one day following vitrectomy surgery were analyzed. Those with IOP measurement following non-vitrectomy surgery were subsequently excluded from the analysis.||mm Hg||Standard Deviation|Mean
664362|NCT01786876|Primary|Percent Total Radioactivity Excreted in Stool of Radiolabelled SSP-002358||Over 240 hours post-dose|Pharmacokinetic (PK) Analysis Set included all subjects with at least 1 PK parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set. Pharmacokinetic Concentration Analysis Set included all subjects who took at least 1 dose of investigational product and underwent plasma PK sampling and had evaluable PK assay results.||percentage of radioactivity||Standard Deviation|Mean
664363|NCT01786876|Primary|Percent Total Radioactivity Excreted in Urine of Radiolabelled SSP-002358||Over 240 hours post-dose|Pharmacokinetic (PK) Analysis Set included all subjects with at least 1 PK parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set. Pharmacokinetic Concentration Analysis Set included all subjects who took at least 1 dose of investigational product and underwent plasma PK sampling and had evaluable PK assay results.||percentage of radioactivity||Standard Deviation|Mean
664364|NCT01786876|Primary|Half-Life Plasma Total Radioactivity of Radiolabelled SSP-002358||Over 240 hours post-dose|Pharmacokinetic (PK) Analysis Set included all subjects with at least 1 PK parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set. Pharmacokinetic Concentration Analysis Set included all subjects who took at least 1 dose of investigational product and underwent plasma PK sampling and had evaluable PK assay results.||hours||Standard Deviation|Mean
664365|NCT01786876|Primary|Tmax Plasma Total Radioactivity of Radiolabelled SSP-002358||Over 240 hours post-dose|Pharmacokinetic (PK) Analysis Set included all subjects with at least 1 PK parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set. Pharmacokinetic Concentration Analysis Set included all subjects who took at least 1 dose of investigational product and underwent plasma PK sampling and had evaluable PK assay results.||hours||Full Range|Median
664366|NCT01786876|Primary|Cmax Plasma Total Radioactivity of Radiolabelled SSP-002358||Over 240 hours post-dose|Pharmacokinetic (PK) Analysis Set included all subjects with at least 1 PK parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set. Pharmacokinetic Concentration Analysis Set included all subjects who took at least 1 dose of investigational product and underwent plasma PK sampling and had evaluable PK assay results.||pg equivalents/ml||Standard Deviation|Mean
664367|NCT01786876|Primary|AUC 0→∞ Plasma Total Radioactivity of Radiolabelled SSP-002358||Over 240 hours post-dose|Pharmacokinetic (PK) Analysis Set included all subjects with at least 1 PK parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set. Pharmacokinetic Concentration Analysis Set included all subjects who took at least 1 dose of investigational product and underwent plasma PK sampling and had evaluable PK assay results.||pg equivalents*h/ml||Standard Deviation|Mean
664368|NCT01786876|Primary|Half-Life Whole Blood Total Radioactivity of Radiolabelled SSP-002358||Over 240 hours post-dose|Pharmacokinetic (PK) Analysis Set included all subjects with at least 1 PK parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set. Pharmacokinetic Concentration Analysis Set included all subjects who took at least 1 dose of investigational product and underwent plasma PK sampling and had evaluable PK assay results.||hours||Standard Deviation|Mean
664369|NCT01786876|Primary|Tmax Whole Blood Total Radioactivity of Radiolabelled SSP-002358||Over 240 hours post-dose|Pharmacokinetic (PK) Analysis Set included all subjects with at least 1 PK parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set. Pharmacokinetic Concentration Analysis Set included all subjects who took at least 1 dose of investigational product and underwent plasma PK sampling and had evaluable PK assay results.||hours||Full Range|Median
664370|NCT01786876|Primary|Cmax Whole Blood Total Radioactivity of Radiolabelled SSP-002358||Over 240 hours post-dose|Pharmacokinetic (PK) Analysis Set included all subjects with at least 1 PK parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set. Pharmacokinetic Concentration Analysis Set included all subjects who took at least 1 dose of investigational product and underwent plasma PK sampling and had evaluable PK assay results.||pg equivalents/ml||Standard Deviation|Mean
664371|NCT01786876|Primary|AUC 0→∞ Whole Blood Total Radioactivity of Radiolabelled SSP-002358||Over 240 hours post-dose|Pharmacokinetic (PK) Analysis Set included all subjects with at least 1 PK parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set. Pharmacokinetic Concentration Analysis Set included all subjects who took at least 1 dose of investigational product and underwent plasma PK sampling and had evaluable PK assay results.||pg equivalents*h/ml||Standard Deviation|Mean
664372|NCT01786876|Primary|Plasma Half-Life (T1/2) of Radiolabelled SSP-002358||Over 240 hours post-dose|Pharmacokinetic (PK) Analysis Set included all subjects with at least 1 PK parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set. Pharmacokinetic Concentration Analysis Set included all subjects who took at least 1 dose of investigational product and underwent plasma PK sampling and had evaluable PK assay results.||hours||Standard Deviation|Mean
664373|NCT01786876|Primary|Time to Maximum Plasma Concentration (Tmax) of Radiolabelled SSP-002358||Over 240 hours post-dose|Pharmacokinetic (PK) Analysis Set included all subjects with at least 1 PK parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set. Pharmacokinetic Concentration Analysis Set included all subjects who took at least 1 dose of investigational product and underwent plasma PK sampling and had evaluable PK assay results.||hours||Full Range|Median
664688|NCT01782872|Secondary|Middle Deltoid|A physical assessment will be done to determine the strength of the middle deltoid muscle in the operative arm using a dynamometer|24 hours after surgery|Patients who agreed to the measurements were included in the analysis.||kgf||Inter-Quartile Range|Median
664374|NCT01786876|Primary|Maximum Plasma Concentration (Cmax) of Radiolabelled SSP-002358|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administered.|Over 240 hours post-dose|Pharmacokinetic (PK) Analysis Set included all subjects with at least 1 PK parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set. Pharmacokinetic Concentration Analysis Set included all subjects who took at least 1 dose of investigational product and underwent plasma PK sampling and had evaluable PK assay results.||pg/ml||Standard Deviation|Mean
664375|NCT01786876|Primary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) of Radiolabelled SSP-002358|Area under the plasma concentration versus time curve from time 0 to infinity. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Over 240 hours post-dose|Pharmacokinetic (PK) Analysis Set included all subjects with at least 1 PK parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set. Pharmacokinetic Concentration Analysis Set included all subjects who took at least 1 dose of investigational product and underwent plasma PK sampling and had evaluable PK assay results.||pg*h/ml||Standard Deviation|Mean
664376|NCT01786707|Secondary|The Number of Subjects With a Reduction of >1% in HbA1c||at 1 year|||Participants|||Count of Participants
664377|NCT01786707|Primary|Number of Participants With a Reduction of HbA1c of >0.5%||1 year|||Participants|||Count of Participants
664378|NCT01786668|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Weeks 2, 4, 8 and 12|FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant’s response to the questions (with the exception of 2 negatively stated), greater was the participant’s fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant’s response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score).|Baseline, Week 2, Week 4, Week 8, Week 12|FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement||Units on a scale||Standard Error|Least Squares Mean
664379|NCT01786668|Secondary|Change From Baseline in EuroQol EQ-5D Health State Profile (EQ-5D) Utility Score at Week 12|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of single utility score. Health state profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depression; Scale range 1 to 3 (1=better health state [no problems], 3=worst health state [confined to bed]).|Baseline, Week 12|FAS||Units on a scale||Standard Error|Least Squares Mean
664380|NCT01786668|Secondary|Change From Baseline to Week 12 in Short-Form-36 Health Survey (SF-36) Physical and Mental Health Scores at Week 12|SF-36 is a standardized survey evaluating 8 aspects of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (0=no functioning, 100=highest level of functioning). Missing data at Week 12 were imputed by LOCF if data at an early visit (discontinuation visit) were available.|Baseline, Week 12|FAS||Units on a scale||Standard Error|Least Squares Mean
664381|NCT01786668|Secondary|Change From Baseline of Mean Spinal Mobility (Chest Expansion) at Week 2, 4, 8 and 12|Chest expansion, measured in centimeters (cm), is defined as the difference in the thoracic circumference during full expiration versus full inspiration. This was measured at the 4th intercostal space. The difference between maximal inspiration and expiration of the two attempts was recorded. The better of the two attempts was used to calculate chest expansion. Missing data at Week 12 were imputed by LOCF if data at an early visit (discontinuation visit) were available.|Baseline, Week 2, Week 4, Week 8, Week 12|FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement||cm||Standard Error|Least Squares Mean
664382|NCT01786668|Secondary|Change From Baseline of Total Swollen Joint Count at Weeks 2, 4 8 and 12|This assessment was performed by the blinded assessor using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints) for determination of the total number of swollen joints. Forty-four joints were assessed for swelling on left and right side and included the following: sternoclaviculars, acromioclaviculars, shoulders, elbows, wrists, metacarpophalangeals (I, II, III, IV, V), thumb interphalangeal, proximal interphalangeals (II, III, IV, V), knees, ankles, and metatarsophalangeals (I, II, III, IV, V). Artificial joints were not assessed. A negative change means improvement.|Baseline, Week 2, Week 4, Week 8, Week 12|FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement||Swollen Joints||Standard Error|Least Squares Mean
664383|NCT01786668|Secondary|Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History|Participants were assessed at Baseline, Week 12 and Week 16 (Follow-up) to determine if they had specific Ankylosing Spondylitis medical history or changes in specific Ankylosing Spondylitis medical history which included: Inflammatory Bowel Disease (IBD), Peripheral Articular Involvement (PAI; as assessed by swollen joint count), psoriasis (PSO) and uveitis (UVE).|Baseline, Week 12 and Follow-up|FAS - n=number of participants completing the Specific Medical History Assessment at each visit.||Percentage of Participants|||Number
664384|NCT01786668|Secondary|Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Weeks 4, 8 and 12|Assessment of enthesitis of 13 sites was performed in the following, 1st costochondral joint left and right, 7th costochondral joint left and right, posterior superior iliac spine left and right, anterior superior iliac spine left and right, iliac crest left and right, 5th lumbar spinous process and proximal insertion of Achilles tendon left and right. Each site was graded for the presence (1) and absence (0) of tenderness yielding total MASES ranging from 0 (no tenderness) to 13 (worst possible score; severe tenderness).|Baseline, Week 4, Week 8, Week 12|FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement||Units on a scale||Standard Error|Least Squares Mean
664405|NCT01786330|Primary|Worst Pain Level Postoperative|"SF-MPQ2 Pain assessment scale was used to measure worst pain level postoperative. The pain assessment was self-administered. Worst pain was reported using a 0 to 10 scale, with 0 being no pain and 10 being pain as bad as you can imagine. Worst pain level is reported as means for each participant group."|24 hours postoperative|||units on a scale||Standard Deviation|Mean
664385|NCT01786668|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Weeks 2, 4, 8 and 12|BASMI is an objective measure of spinal mobility and was completed by a blinded assessor. The BASMI score is composed of 5 clinical measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. The derived score used the average of the 5 assessments on a scale of 0-10 scale with higher scores indicating more impairment of spinal mobility. BASMI was analyzed using the linear function method. The higher the negative value the better the improvement.|Baseline, Week 2, Week 4, Week 8, Week 12|FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement||Units on a scale||Standard Error|Least Squares Mean
664386|NCT01786668|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, 8 and 12|BASFI is a validated self-assessment tool that determines the degree of physical functional limitation in Ankylosing Spondylitis. Utilizing a Numerical Rating Scale (NRS) of 0-10 (0=easy, 10=impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions with lower scores indicating better physical function. The higher the negative value the better the improvement.|Baseline, Week 2, Week 4, Week 8, Week 12|FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement||Units on a scale||Standard Error|Least Squares Mean
664387|NCT01786668|Secondary|Percentage of Participants Achieving a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)50 Response at Weeks 2, 4, 8 and 12|BASDAI is a validated self-assessment tool used to determine disease activity in participant with Ankylosing Spondylitis. Utilizing a Numerical Rating Scale (NRS) of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is calculated by computing the mean of questions 5 and 6 and adding it to the sum of questions (Q)1-4. This score is then divided by 5. The final BASDAI score range from 0-10. A positive response was defined as a 50% improvement in the BASDAI from baseline.|Baseline, Week 2, Week 4, Week 8, Week 12|FAS - n=number of responders at each visit||Percentage of participants|||Number
664388|NCT01786668|Secondary|Change From Baseline in BASDAI Total Score at Week 2, 4, 8 and 12|BASDAI is a validated self-assessment tool used to determine disease activity in participant with Ankylosing Spondylitis. Utilizing a Numerical Rating Scale (NRS) of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is calculated by computing the mean of questions 5 and 6 and adding it to the sum of questions (Q)1-4. This score is then divided by 5. BASDAI=Q1+Q2+Q3+Q4+[Q5+Q6/2]/5. The final BASDAI score averages the individual assessments for a final score range of 0-10. Negative values indicate improvement.|Baseline, Week 2, Week 4, Week 8, Week 12|FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement||Units on a scale||Standard Error|Least Squares Mean
664389|NCT01786668|Secondary|Percentage of Participants Achieving ASDAS Inactive Disease at Weeks 2, 4, 8 and 12|The ASDAS inactive disease was calculated from the ASDAS data. The ASDAS inactive disease was defined as ASDAS <1.3 units. Missing data were handled by NRI/LOCF.|Baseline, Week 2, Week 4, Week 8, Week 12|FAS - n=number of responders at each visit||Percentage of participants|||Number
664390|NCT01786668|Secondary|Percentage of Participants With ASDAS Major Improvement at Weeks 2, 4, 8 and 12|The ASDAS major improvement was calculated from the ASDAS data. The ASDAS major improvement was defined as change (decrease) from baseline of ≥2.0 units. Missing data were handled by NRI/LOCF.|Baseline, Week 2, Week 4, Week 8, Week 12|FAS - n=number of responders at each visit||Percentage of participants|||Number
664391|NCT01786668|Secondary|Percentage of Participants With ASDAS Clinically Important Improvement at Weeks 2, 4, 8 and 12|The ASDAS clinically important improvement was calculated from the ASDAS data. The ASDAS clinically important improvement is defined as change (decrease) from baseline of ≥1.1 units. Missing data were handled by NRI/LOCF.|Baseline, Week 2, Week 4, Week 8, Week 12|FAS - n=number of responders at each visit||Percentage of participants|||Number
664392|NCT01786668|Secondary|Change From Baseline of Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein ASDAS(CRP) at Weeks 2, 4, 8 and 12|The ASDAS(CRP) is a derived score that uses back pain, duration of morning stiffness, Patient's Global Assessment of their disease and peripheral pain/swelling. The formula used for calculating the ASDAS (CRP)is: 0.12 x Back Pain + 0.06 x Duration of Morning Stiffness + 0.11 x Patient Global + 0.07 x Peripheral Pain/Swelling + 0.58 x Ln(CRP+1). The calculated score can be from 0 to no defined upper limit. A negative number indicates a reduction in the score which indicates decrease in disease activity.|Baseline, Week 2, Week 4, Week 8, Week 12|FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement||Units on a scale||Standard Error|Least Squares Mean
664393|NCT01786668|Secondary|Percentage of Participants Achieving ASAS5/6 Response at Weeks 2, 4, 8 and 12|ASAS5/6 consists of 6 domains: the 4 used in ASAS20 (Patient's Global Assessment of Disease Activity, spinal pain, function, inflammation plus spinal mobility and an acute phase reactant, C Reactive Protein (CRP). ASAS 5/6 is defined as ≥20% improvement in at least 5 domains and no worsening in the remaining domain. Missing data were handled by NRI/LOCF.|Baseline, Week 2, Week 4, Week 8, Week 12|FAS - n=number of responders at each visit||Percentage of participants|||Number
664394|NCT01786668|Secondary|Percentage of Participants Achieving 40% Improvement in ASAS Score at Weeks 2, 4, 8 and 12|ASAS 40 is defined as ≥40% and absolute change of ≥2 units in at least 3 domains on a 0-10 scale (0=no disease activity, 10=high disease activity), and no worsening in the remaining domain. Missing data were handled by NRI/LOCF.|Baseline, Week 2, Week 4, Week 8, Week 12|FAS - n=number of responders at each visit.||Percentage of participants|||Number
664404|NCT01786551|Primary|Vascular and Systemic Inflammation as Measured by Interleukin-6 (IL-6) Serum Levels|At Visit 1, blood was drawn before and then 2h and 4h after a high-fat/high-glucose meal (50 g fat, 75 g glucose). Participants then followed a low-dose eplerenone treatment (50 mg daily) for 14 days. At Visit 2, blood was drawn again before, 2h, and 4h after a high-fat/high-glucose meal after 14 days.|Baseline, 2 hours, and 4 hours, measured before and after 2 weeks of eplerenone treatment|Data reported for evaluable participants only. All participants who completed the study and had glucose data available.||ng/mL||Standard Deviation|Mean
664519|NCT01785186|Secondary|Rate of Change in Time to Positivity|Rate of change in time to positivity in BD MGIT 960® liquid culture|0 - 12 weeks||||||
664395|NCT01786668|Secondary|Change From Baseline in Modified Berlin Ankylosing Spondylitis Spine Magnetic Resonance Imaging Activity Score (ASspiMRI) of the Spine at Week 12|Berlin modification of the ASspiMRI is a measure of acute lesion as determined by short-tau inversion recovery (STIR) sequences. All 23 disco-vertebral units (DVU) of the spine (from C2 to S1), defined as the region between 2 virtual lines through the middle of each vertebra, were scored in a single dimension, which is represented the highest level of inflammation in that particular DVU. Total spine ASspiMRI scores can range from 0-69 with higher scores indicating more disease activity. A negative change from baseline indicates improvement. Missing data at Week 12 were imputed by LOCF if data at an early visit (discontinuation visit) were available.|Baseline, Week 12|FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement||Units on a scale||Standard Error|Least Squares Mean
664396|NCT01786668|Secondary|Change From Baseline in SPARCC MRI Index of Disease Activity Score of the Spine at Week 12|SPARCC scoring of the magnetic resonance imaging (MRI) of the spine consists of assessing six disco-vertebral units (DVU) with 3 consecutive sagittal slices at each DVU. The minimum and maximum SPARCC score for all 6 DVUs is 0 to 108, with higher scores indicating more damage. A negative change from baseline indicates improvement. Missing data at Week 12 were imputed by LOCF if data at an early visit (discontinuation visit) were available.|Baseline, Week 12|FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement||Units on a scale||Standard Error|Least Squares Mean
664397|NCT01786668|Secondary|Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Index of Disease Activity Score of the Sacroiliac (SI) Joints at Week 12|SPARCC scoring consists of assessing six SI joint MRI image coronal slices representing the largest proportion of the synovial compartment of the SI joints for edema. The maximum score per slice was 2 and 12 for all 6 slices. The total minimum and maximum score for all SI joints across 6 slices is 0 to 72 and higher scores indicate more inflammation. A negative change from baseline indicates improvement. Missing data at Week 12 were imputed by LOCF if data at an early visit (discontinuation visit) were available.|Baseline, Week 12|FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement||Units on a scale||Standard Error|Least Squares Mean
664398|NCT01786668|Secondary|Percentage of Participants Achieving 20% Improvement in ASAS Score at Weeks 2, 4 and 8|Clinical response to treatment was assessed according to ASAS20 criteria. ASAS20 responder had improvement of ≥ 20% and ≥1 unit in at least 3 domains (on a scale of 0 [least] to 10 [worst]) and no worsening of ≥20% and ≤1 unit in the remaining domain. The domains are: Patient's Global Assessment of Disease Activity, spinal pain, function and inflammation (from Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]). Missing data were handled by NRI/LOCF. Missing values due to a subject dropping out from the study were handled by setting the ASAS20 value to NRI. The LOCF approach was applied to missing components, if just some of the components of the ASAS20 were missing.|Baseline, Week 2, Week 4, Week 8|FAS - n=number of responders at each visit.||Percentage of participants|||Number
664399|NCT01786668|Primary|Percentage of Participants Achieving ASAS20 at Week 12|The supportive analysis of this outcome measure was performed using the normal approximation for two proportions. Clinical response to treatment was assessed according to ASAS20 criteria. ASAS20 responder had improvement of ≥ 20% and ≥1 unit in at least 3 domains (on a scale of 0 [least] to 10 [worst]) and no worsening of ≥20% and ≤1 unit in the remaining domain. The domains are: Patient's Global Assessment of Disease Activity, spinal pain, function and inflammation (from Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]). Missing data were handled by NRI/LOCF. Missing values due to a subject dropping out from the study were handled by setting the ASAS20 value to NRI. The LOCF approach was applied to missing components, if just some of the components of the ASAS20 were missing.|Baseline, Week 12|FAS||Percentage of participants|||Number
664400|NCT01786668|Primary|Percentage of Participants Achieving 20 Percent (%) Improvement in Assessment of SpondyloArthritis International Society (ASAS) Score (ASAS 20) at Week 12|The primary analysis of this outcome measure was performed using the Emax model. Clinical response to treatment was assessed according to ASAS20 criteria. ASAS20 responder had improvement of greater than or equal to (≥) 20% and ≥1 unit in at least 3 domains (on a scale of 0 [least] to 10 [worst]) and no worsening of ≥20% and less than or equal to (≤)1 unit in the remaining domain. The domains are: Patient's Global Assessment of Disease Activity, spinal pain, function and inflammation (from Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]). Missing data were handled by nonresponsive (NRI)/ last observation carried forward (LOCF). Missing values due to a subject dropping out from the study were handled by setting the ASAS20 value to NRI. The LOCF approach was applied to missing components, if just some of the components of the ASAS20 were missing.|Week 12|Full Analysis Set (FAS): included all participants who were randomized to the study and received at least one dose of the randomized study drug (Tofacitinib or placebo).||Percentage of participants|||Number
664401|NCT01786629|Primary|"Percentage of Subjects With a Successful Preparation (Cleaning Rated as Good or Excellent)"||Day of colonoscopy|The analysis population contains subjects that consumed any portion of their bowel preparation. Subject who discontinued from the study for reasons other safety of efficacy are not included (e.g. insurance issues).||percentage of subjects|||Number
664402|NCT01786551|Secondary|Post-prandial Insulin Serum Levels|At Visit 1, blood was drawn before and then 2h and 4h after a high-fat/high-glucose meal (50 g fat, 75 g glucose). Participants then followed a low-dose eplerenone treatment (50 mg daily) for 14 days. At Visit 2, blood was drawn again before, 2h, and 4h after a high-fat/high-glucose meal after 14 days.|Baseline, 2 hours, and 4 hours, measured before and after 2 weeks of eplerenone treatment|Data reported for evaluable participants only. All participants who completed the study and had glucose data available.||uU/ml||Standard Deviation|Mean
664403|NCT01786551|Secondary|Post-prandial Glucose Serum Levels|At Visit 1, blood was drawn before and then 2h and 4h after a high-fat/high-glucose meal (50 g fat, 75 g glucose). Participants then followed a low-dose eplerenone treatment (50 mg daily) for 14 days. At Visit 2, blood was drawn again before, 2h, and 4h after a high-fat/high-glucose meal after 14 days.|Baseline, 2 hours, and 4 hours, measured before and after 2 weeks of eplerenone treatment|Data reported for evaluable participants only. All participants who completed the study and had glucose data available.||mg/dl||Standard Deviation|Mean
664520|NCT01785186|Secondary|Proportion of Negative Sputum Cultures|Proportion of patients converting to negative sputum culture (2 consecutive weekly cultures) in liquid and solid media|0 - 12 weeks||||||
664406|NCT01786330|Primary|Average Pain Level Postoperative|"SF-MPQ2 Pain assessment scale was used to measure average pain level postoperative. The pain assessment was self-administered. Average pain was reported using a 0 to 10 scale, with 0 being no pain and 10 being pain as bad as you can imagine. Reported average pain level is reported as means for each participant group."|24 hours postoperative|||units on a scale||Standard Deviation|Mean
664407|NCT01786330|Primary|Lowest Pain Level Postoperative|"SF-MPQ2 Pain assessment scale was used to measure lowest pain level postoperative. The pain assessment was self-administered. Lowest pain was reported using a 0 to 10 scale, with 0 being no pain and 10 being pain as bad as you can imagine. Lowest pain level is reported as means for each participant group."|24 hours postoperative|||units on a scale||Standard Deviation|Mean
664408|NCT01786330|Secondary|Change in Hemoglobin Concentration|Hemoglobin concentration will be assessed 24 hours after surgery by assessing routine post-operative lab values. Outcome is reported as average difference between pre-operative hemoglobin concentration and post-operative hemoglobin concentration. The negative number indicates the drop in hemoglobin concentration postoperatively.|24 hours from baseline|||g/dL||Standard Deviation|Mean
664409|NCT01786252|Primary|Expression of hCG Target C3 Protein by IHC in Endometrial Stroma|Staining intensity of each section was quantified by image analysis software ImageJ (NIH) resulting in a Digital Histology Score (D-HSCORE), ranging from 0 to 255. Higher scores are associated with stronger staining/expression, while lower scores are the opposite.|2 days following infusion of hCG or IVF media|||D-HSCORE||Standard Deviation|Mean
664410|NCT01786252|Primary|Expression of hCG Target NOTCH1 Protein by IHC in Endometrial Stroma|Staining intensity of each section was quantified by image analysis software ImageJ (NIH) resulting in a Digital Histology Score (D-HSCORE), ranging from 0 to 255. Higher scores are associated with stronger staining/expression, while lower scores are the opposite.|2 days following infusion of hCG or IVF media|||D-HSCORE||Standard Deviation|Mean
664411|NCT01786252|Primary|Expression of hCG Target NOTCH1 Protein by IHC in Endometrial Glands|Staining intensity of each section was quantified by image analysis software ImageJ (NIH) resulting in a Digital Histology Score (D-HSCORE), ranging from 0 to 255. Higher scores are associated with stronger staining/expression, while lower scores are the opposite.|2 days following infusion of hCG or IVF media|||D-HSCORE||Standard Deviation|Mean
664412|NCT01786252|Primary|Endometrial Staging in hCG Versus Vehicle Treated Patients|All H&E-stained endometrial biopsies were analyzed in a blinded manner for endometrial dating and glandular and stromal development. Criteria for endometrial dating included the presence or absence of sub-nuclear vacuoles, which is one of the more reproducible features of the Noyes dating criteria. For the purposes of statistical analysis, the most advanced elements in each of the two endometrial compartments were considered. Data are specifically reported as days post-ovulation induction.|2 days following infusion of hCG or IVF media|||days||Standard Error|Mean
664413|NCT01786239|Primary|Treatment Response|The primary outcome measure will be the total Brief Psychiatric Rating Scale Score. The range of the BPRS is 0 to 126 with higher scores indicated more psychological symptoms.|16 weeks|||units on a scale||Standard Error|Least Squares Mean
664414|NCT01786174|Secondary|Forced Expiratory Volume in 1 Second (FEV1) / Slow Vital Capacity (SVC) Ratio|"Forced Expiratory Volume (FEV1): Forced Expiratory Volume (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.
Slow Vital Capacity (SVC): Vital Capacity is the maximum amount of air a person can expel from the lungs after a maximum inhalation. A subject's VC depends on their age, sex and height. The value is recorded as a percent of predicted normal."|Screening, Week 0, Week 2, and Week 4|The reported results are model estimates from a model that estimates a single baseline value across all randomized participants, i.e., reflecting the true state of the population prior to randomization.||Percentage of predicted max value||95% Confidence Interval|Mean
664415|NCT01786174|Primary|Forced Expiratory Volume in 1 Second (FEV1)|Forced Expiratory Volume (FEV1): Forced Expiratory Volume (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.|Screening, Week 0, Week 2, and Week 4|The reported results are model estimates from a model that estimates a single baseline value across all randomized participants, i.e., reflecting the true state of the population prior to randomization.||Percentage of predicted max value||95% Confidence Interval|Mean
664416|NCT01786174|Primary|Change in Slow Vital Capacity Score (SVC)|The vital capacity (VC) (percent of predicted normal) was determined using the slow VC method. Vital Capacity is the maximum amount of air a person can expel from the lungs after a maximum inhalation. A subject's VC depends on their age, sex and height. The value is recorded as a percent of predicted normal.|Week 0, Week 2, Week 4 and Week 8|||Percentage of predicted max value||95% Confidence Interval|Mean
664417|NCT01786174|Primary|ALSFRS-R Total Score at Weeks 0, 2, 4 and 8|The ALSFRS-R is a quickly administered (5 minutes) ordinal rating scale (ratings 0-4) used to determine subjects' assessment of their capability and independence in 12 functional activities. All 12 activities are relevant in ALS. Initial validity was established by documenting that in ALS patients, change in ALSFRS-R scores correlated with change in strength over time, was closely associated with quality of life measures, and predicted survival.|Week 0, Week 2, Week 4 and Week 8|The reported results are model estimates from a model that estimates a single baseline value across all randomized participants, i.e., reflecting the true state of the population prior to randomization.||scores on a scale||95% Confidence Interval|Mean
664418|NCT01786174|Secondary|Lymphocyte (T-Cell) Subset Trajectories|Gilenya (fingolimod) has been shown to successfully reduce circulating lymphocytes (a type of white blood cell) by blocking their egress (exit) from the lymph nodes. A secondary objective of the study is to quantify the effect of the treatment on circulating lymphocyte populations in patients with ALS.|Week 0, Week 2, and Week 4|||10^3/uL||95% Confidence Interval|Mean
664419|NCT01786161|Secondary|Vancomycin Concentration at 24 Hours|The therapeutic level was defined as 15-20 mcg/mL for IIV and 15-25 mcg/mL for CIV|24 hours|||mcg/mL||Standard Deviation|Mean
664420|NCT01786161|Secondary|Time Required to Reach the Therapeutic Levels|The therapeutic level was defined as 15-20 mcg/mL for IIV and 15-25 mcg/mL for CIV|as long as participants are receiving Vancomycin (mean (SD) 9 (3.8) days for continuous, 8.4 (4.1) days for intermittent)|||hours||Standard Deviation|Mean
664421|NCT01786161|Primary|Number of Participants Who Achieved the Target Vancomycin Concentration|The therapeutic level was defined as 15-20 mcg/mL for IIV and 15-25 mcg/mL for CIV|24 hours|||Participants|||Count of Participants
664422|NCT01786109|Secondary|Post-Treatment Sensory Threshold for First Perception of Gas|The sensory threshold for first perception of gas was measured by stepwise inflation in increments of 4 mm Hg at 60 second intervals up to a maximum pressure of 64 mm Hg. During this assessment participants were asked to report when they had the first sensation. The investigator recorded the threshold pressure at which the participants reported this sensation.|1 hour after drug was ingested|Intention-to-treat analysis||mm Hg||Standard Deviation|Mean
664423|NCT01786109|Secondary|Post-treatment Sensory Threshold for First Sensation|The sensory threshold for first sensation was measured by stepwise inflation in increments of 4 mm Hg at 60 second intervals up to a maximum pressure of 64 mm Hg. During this assessment participants were asked to report when they had the first sensation. The investigator recorded the threshold pressure at which the participants reported this sensation.|1 hour after drug was ingested|Intention-to-treat analysis||mm Hg||Standard Deviation|Mean
664424|NCT01786109|Secondary|Postprandial Colonic Motility Index|Colonic phasic pressure activity is summarized as a motility index (MI)=log_e[number of contractions * sum of amplitudes) + 1]. A normal fasting average motility index (MI) would be about 12. An increase in MI means an increase in the phasic contractions (in contrast to tone) which is measured as a change in volume of the barostat balloon. (Therefore, an increase in MI means that the meal is moving more quickly through the colon.)|1 hour after ingestion of standard meal|Intention-to-treat analysis||log mm Hg||Standard Deviation|Mean
664425|NCT01786109|Secondary|Fasting Colonic Tone|Colonic tone is a measurement of the volume of the colon. Colonic tone was assessed by noting the changes in the balloon volume in the presence of a constant operating pressure in the balloon (in the barostat-manometric assembly placed in the colon.)|After 12 hour fast, before drug administered|Intention-to-treat analysis||mL||Standard Error|Mean
664426|NCT01786109|Secondary|Post-Treatment Overall Sensory Rating in Response to 16, 24, 32, and 40 mm Hg Distensions|The sensory rating was measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes of 0 for no pain and 100 mm for extreme pain. The investigator measures the mark made by the participant in mm and records this for the value of pain.|1 hour after drug was ingested|Intention-to-treat analysis||mm||Standard Error|Mean
664427|NCT01786109|Secondary|Post-treatment Sensory Threshold for First Perception of Pain|The sensory threshold for first perception of pain was measured by stepwise inflation in increments of 4 mm Hg at 60 second intervals up to a maximum pressure of 64 mm Hg. During this assessment participants were asked to report when they had the first sensation. The investigator recorded the threshold pressure at which the participants reported this sensation.|1 hour after drug was ingested|Intention-to-treat analysis||mm Hg||Standard Deviation|Mean
664428|NCT01786109|Secondary|Postprandial Change in Colonic Tone|Colonic tone is a measurement of the volume of the colon. Colonic tone was assessed by noting the changes in the balloon volume in the presence of a constant operating pressure in the balloon (in the barostat-manometric assembly placed in the colon.)|1 hour after ingestion of standard meal|Intention-to-treat analysis||mL||Standard Error|Mean
664429|NCT01786109|Primary|Colonic Compliance at Pressure at Half-Maximum Volume (Pr 1/2)|"Colonic compliance is a measure of the stiffness of the colon, that is, what pressure was needed to reach half the maximum volume of the colon.
After the barostat catheter was inserted in the colon, the catheter was connected to a barostat machine. After an initial conditioning distension to 20 mm Hg, colonic compliance was measured by step-wise inflation with increments of 4 mm Hg up to 64 mm Hg. Colonic compliance was analyzed by a validated linear interpolation method. The pressure at half maximum volume serves as a summary of colonic compliance."|1 hour after drug was ingested|Intention-to-treat analysis||mL/mm Hg||Standard Error|Mean
664430|NCT01785875|Primary|Change From Baseline in Blood Pressure|Blood pressure (BP) values were taken post-hemodialysis assessments.|Baseline and Weeks 24 and 48|Participants who received at least 1 dose of etelcalcetide and with available data at each time point (indicated by n)||mmHg||Standard Error|Mean
664431|NCT01785875|Secondary|Percent Change From Baseline in Mean Phosphorus During the EAP12||Baseline and the efficacy assessment phase at month 12 (weeks 46-53)|Participants with available data||percent change||Standard Error|Mean
664432|NCT01785875|Secondary|Percent Change From Baseline in Mean Phosphorus During the EAP||Baseline and the efficacy assessment phase|Participants with available data||percent change||Standard Error|Mean
664433|NCT01785875|Secondary|Percent Change From Baseline in Mean Corrected Calcium Phosphorus Product During the EAP12||Baseline and the efficacy assessment phase at month 12 (weeks 46-53)|Participants with available data||percent change||Standard Error|Mean
664434|NCT01785875|Secondary|Percent Change From Baseline in Mean Corrected Calcium Phosphorus Product During the EAP||Baseline and the efficacy assessment phase|Participants with available data||percent change||Standard Error|Mean
664435|NCT01785875|Secondary|Percent Change From Baseline in Mean Corrected Calcium During the EAP12||Baseline and the efficacy assessment phase at month 12 (weeks 46-53)|Participants with available data||percent change||Standard Error|Mean
664436|NCT01785875|Secondary|Percent Change From Baseline in Mean Corrected Calcium During the EAP||Baseline and the efficacy assessment phase|Participants with available data||percent change||Standard Error|Mean
664437|NCT01785875|Secondary|Percent Change From Baseline in Mean PTH During the EAP12||Baseline and the efficacy assessment phase at month 12 (weeks 46-53)|Participants with available data||percent change||Standard Error|Mean
664438|NCT01785875|Secondary|Percent Change From Baseline in Mean PTH During the EAP||Baseline and the efficacy assessment phase|Participants with available data||percent change||Standard Error|Mean
664439|NCT01785875|Secondary|Percentage of Participants With PTH ≤ 300 pg/mL During the EAP12||Week 46 to 53|Participants with predialysis PTH assessment during the EAP12||percentage of participants||95% Confidence Interval|Number
664440|NCT01785875|Secondary|Percentage of Participants With PTH ≤ 300 pg/mL During the EAP||Baseline and the efficacy assessment phase|Participants with predialysis PTH assessment during the EAP who completed a minimum of 8 weeks of treatment with etelcalcetide||percentage of participants||95% Confidence Interval|Number
664441|NCT01785875|Secondary|Percentage of Participants With > 30% Reduction From Baseline in PTH During the EAP12|The efficacy assessment phase at 12 months (EAP12) was defined as the period from week 46 to 53 (inclusive). If multiple assessments were available during the EAP12, values were averaged.|Baseline and the efficacy assessment phase at month 12 (weeks 46-53)|Participants with pre-dialysis PTH assessment at baseline and during EAP12||percentage of participants||95% Confidence Interval|Number
664442|NCT01785875|Secondary|Percentage of Participants With > 30% Reduction From Baseline in PTH During the Efficacy Assessment Phase|The efficacy assessment phase (EAP) is defined as the last 6 weeks before ending treatment, which was only for participants who completed a minimum of 8 weeks of treatment with etelcalcetide. If multiple assessments were available during the EAP, values were averaged.|Baseline and the efficacy assessment phase, defined as the last 6 weeks prior to ending treatment for participants who completed a minimum of 8 weeks of treatment (weeks 46-52 for participants who completed 52 weeks of treatment)|Participants with pre-dialysis PTH assessment at baseline and during the EAP who completed a minimum of 8 weeks of treatment with etelcalcetide.||percentage of participants||95% Confidence Interval|Number
664443|NCT01785875|Primary|Number of Participants Who Developed Anti-etelcalcetide Antibodies|A validated dual flow-cell biosensor immunoassay was used to detect antibodies capable of binding etelcalcetide. The number of participants with a negative or no result at baseline and positive binding antibodies at any time post-baseline is reported.|Baseline, Week 12, Week 24, Week 36, Week 53, the 30-day follow-up visit|Participants who received at least 1 dose of etelcalcetide and with a post-baseline antibody result.||participants|||Number
664444|NCT01785875|Primary|Number of Participants With Shift in Laboratory Values From Baseline Grade 0 or 1 to Post-baseline Grade 3 or 4|Laboratory toxicity grading was based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, where Grade 0 represents values in the normal range and grade 4 represents values with life-threatening consequences and urgent intervention indicated.|52 weeks|All participants who received at least 1 dose of etelcalcetide.||participants|||Number
664445|NCT01785875|Primary|Number of Participants With Adverse Events (AEs)|Treatment-related adverse events are those the investigator indicated as having a reasonable possibility of having been caused by etelcalcetide. A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria: • fatal • life threatening • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • congenital anomaly/birth defect • other medically important serious event.|From first dose until 30 days after last dose; the treatment period was 52 weeks.|All participants who received at least 1 dose of etelcalcetide.||participants|||Number
664446|NCT01785849|Secondary|Percent Change From Baseline in Predialysis Phosphorus During the Efficacy Assessment Phase||Baseline and the efficacy assessment phase (Week 20 to Week 27)|Full analysis set participants with observed data||percent change||Standard Deviation|Mean
664447|NCT01785849|Secondary|Percent Change From Baseline in Predialysis Corrected Calcium Phosphorus Product During the Efficacy Assessment Phase||Baseline and the efficacy assessment phase (Week 20 to Week 27)|Full analysis set participants with observed data||percent change||Standard Error|Mean
664448|NCT01785849|Secondary|Percent Change From Baseline in Predialysis Corrected Calcium During the Efficacy Assessment Phase||Baseline and the efficacy assessment phase (Week 20 to Week 27)|Full analysis set participants with observed data||percent change||Standard Error|Mean
664449|NCT01785849|Secondary|Percent Change From Baseline in Predialysis PTH During the Efficacy Assessment Phase||Baseline and the Efficacy Assessment Phase (Week 20 to Week 27)|Full analysis set participants with observed data||percent change||Standard Error|Mean
664450|NCT01785849|Secondary|Percentage of Participants With Mean Predialysis Parathyroid Hormone ≤ 300 pg/mL During the Efficacy Assessment Phase|Participants who had no scheduled assessments during the EAP were considered non-responders.|Baseline and the efficacy assessment phase (Week 20 to Week 27)|Full analysis set||percentage of participants|||Number
664451|NCT01785849|Primary|Percentage of Participants With a > 30% Decrease From Baseline in Mean PTH During the Efficacy Assessment Phase|Participants who did not have any scheduled assessments during the EAP were considered non-responders.|Baseline and the efficacy assessment phase (EAP; defined as Weeks 20 to 27, inclusive).|The full analysis set, consisting of all randomized participants||percentage of participants|||Number
664452|NCT01785628|Other Pre-specified|Change in Brain Imaging by [99mTc]TRODAT-1 From Baseline to 8 Weeks.|[99mTc]TRODAT-1 : 7 patients for treatment and placebo groups, respectively.|baseline to 8 weeks||||||
664453|NCT01785628|Other Pre-specified|Change in Brain Imaging by 18F-FDG PET From Baseline to 8 Weeks.|18F-FDG PET scan : 8 patients for treatment and placebo groups,respectively.|baseline to 8 weeks||||||
664454|NCT01785628|Secondary|Change in The 39-item Parkinson's Disease Questionnaire (PDQ-39) From Baseline to 8 Weeks.|The PDQ-39 contains 39-items covering 8 discrete dimensions: mobility, activities of daily living, emotional well-being, stigma, social support, cognitions, communication, and bodily discomfort. Each question is scored on a 5-point scale and recoded to 0 to 4 for the analysis. The total score can range from 0 to 132 and with a higher score indicating more severe symptoms.|baseline to 8 weeks|ITT Population||Scores on a scale||Standard Deviation|Mean
664455|NCT01785628|Secondary|Change in Beck Depression Inventory-II (BDI-II) From Baseline to 8 Weeks.|The BDI-II is a 21-item self-report questionnaire assessing the current severity of depression symptoms. Each item is scored on a scale of 0 to 3 and the total score ranges from 0 to 63. With a higher score indicating more severe symptoms.|baseline to 8 weeks|ITT Population||Scores on a scale||Standard Deviation|Mean
664456|NCT01785628|Secondary|Change in Hamilton Depression Rating Scale (HAM-D) From Baseline to 8 Weeks.|The HAM-D is a 21-item rating scaled which includes an emphasis on behavioral symptoms and somatic complaints that neglects self-reported feelings of distress; and an intermingling of frequency and intensity of symptoms. The total score ranges from 0 to 64: ten items are ranked on a scale from 0 to 4; 9 items are ranked 0 to 2; and 2 items are ranked 0 to 3. With a higher score indicating more severe symptoms.|baseline to 8 weeks|||Scores on a scale||Standard Deviation|Mean
664457|NCT01785628|Secondary|Change in Behavioral Pathology in Alzheimer's Disease Rating Scale (Behave-AD) From Baseline to 8 Weeks.|The Behave-AD includes the assessment of symptoms and a global rating of caregiver distress. A total of 25 symptoms in 7 clusters are rated: paranoid and delusional ideation, hallucinations, aggressiveness, activity disturbances, diurnal rhythm disturbances, affective disturbances and anxieties, and phobias. Caregivers rate behavioral symptoms over the preceding 2 weeks on a 0 to 3 scale. The caregiver also determines a global assessment of caregiver distress on a scale of 0 to 3. The maximum score is 75 and with a higher score indicating more severe symptoms.|baseline to 8 weeks|||Scores on a scale||Standard Deviation|Mean
664521|NCT01785186|Secondary|Time to First Negative Culture on Liquid and Solid Media|Time to a convert to a single negative culture on liquid and solid media|0 - 12 weeks||||||
664458|NCT01785628|Secondary|Change in Neuropsychiatry Inventory (NPI) From Baseline to 8 Weeks.|The NPI scale has 12 domains: delusions, hallucinations, agitation, dysphoria, anxiety, apathy, irritability, euphoria, disinhibition, aberrant motor behavior, night-time behavior disturbances, and appetite and eating abnormalities. The total score ranges from 0 to 144, where the score for a domain is defined as the product of frequency (range: 1-4) and severity (range: 1-3). Each domain has a maximum score of 12 and with a higher score indicating more severe symptoms.|baseline to 8 weeks|ITT Population||Scores on a scale||Standard Deviation|Mean
664459|NCT01785628|Secondary|Change in Clinical Dementia Rating (CDR) From Baseline to 8 Weeks.|The CDR is a 5-point scale used to characterize six domains of cognitive and functional performance applicable to Alzheimer disease and related dementias: Memory, Orientation, Judgment & Problem Solving, Community Affairs, Home & Hobbies, and Personal Care. With a higher score indicating more severe symptoms.|baseline to 8 weeks|ITT Population||Scores on a scale||Standard Deviation|Mean
664460|NCT01785628|Secondary|Change in Cognitive Abilities Screening Instrument (CASI) From Baseline to 8 Weeks.|The Cognitive Abilities Screening Instrument (CASI) has a score range of 0 to 100 and provides quantitative assessment on attention, concentration, orientation, short-term memory, long-term memory, language abilities, visual construction, list-generating fluency, abstraction, and judgment. With a higher score indicating Symptom improvement.|baseline to 8 weeks|ITT Population||Scores on a scale||Standard Deviation|Mean
664461|NCT01785628|Primary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) From Baseline to 8 Weeks.|Outcome is defined as change in total Unified Parkinson's Disease Rating Scale (UPDRS) between the baseline to 8 weeks. The UPDRS score has three parts, part I (Mentation, Behavior and Mood), Part II (Activities of Daily Living) and Part III (Motor Examination). Each consisting of questions answered on a 0-4 point scale. The minimum total score possible is 0 and the maximum total score possible is 176. Higher scores indicating more severe symptoms.|baseline to 8 weeks.|The Intent-to-Treat (ITT) Population comprised all randomised patients who took at least one dose of study medication or placebo and who had a valid baseline efficacy measure and at least one post-baseline efficacy measure.||Scores on a scale||Standard Deviation|Mean
664462|NCT01785615|Secondary|Mean Plasminogen Activator Inhibitor-1 in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|0 weeks|||ng/ml||Standard Deviation|Mean
664463|NCT01785615|Secondary|Mean Leptin in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|0 weeks|||pg/ml||Standard Deviation|Mean
664464|NCT01785615|Secondary|Mean Hs-C Reactive Protein in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|0 weeks|||ng/ml||Standard Deviation|Mean
664465|NCT01785615|Secondary|Mean Apolipoprotein B/ Apolipoprotein A1 Ratio in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing. The ratio of Apo B to Apo A1 ratio was calculated.|0 weeks|||ratio||Standard Deviation|Mean
664466|NCT01785615|Secondary|Mean Apolipoprotein B in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|0 weeks|||mg/dl||Standard Deviation|Mean
664467|NCT01785615|Secondary|Mean Apolipoprotein A-1 in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|0 weeks|||mg/dl||Standard Deviation|Mean
664468|NCT01785615|Secondary|Mean Vascular Adhesion Molecule in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|0 weeks|||ng/ml||Standard Deviation|Mean
664469|NCT01785615|Secondary|Mean Diastolic Blood Pressure|Measured with a blood pressure cuff|0 weeks|||mm Hg||Standard Deviation|Mean
664470|NCT01785615|Secondary|Mean Systolic Blood Pressure|Measured with a blood pressure cuff|0 weeks|||mm Hg||Standard Deviation|Mean
664471|NCT01785615|Secondary|Mean Intercellular Adhesion Molecule in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|0 weeks|||ng/ml||Standard Deviation|Mean
664472|NCT01785615|Secondary|Mean High Density Lipoprotein Cholesterol in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|0 weeks|||mg/dl||Standard Deviation|Mean
664473|NCT01785615|Secondary|Mean Fasting Blood Glucose in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|0 weeks|||mg/dl||Standard Deviation|Mean
664474|NCT01785615|Secondary|Mean Myeloperoxidase in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|0 weeks|||ng/ml||Standard Deviation|Mean
664475|NCT01785615|Secondary|Mean Triglycerides in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|0 weeks|||mg/dl||Standard Deviation|Mean
664476|NCT01785615|Secondary|Mean Low Density Lipoprotein Cholesterol in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|0 weeks|||mg/dl||Standard Deviation|Mean
664477|NCT01785615|Secondary|Mean Waist Circumference|Waist circumference was measured with a ruler tape.|week 0|||inches||Standard Deviation|Mean
664478|NCT01785615|Primary|Mean Myeloperoxidase in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|6 weeks|||ng/ml||Standard Deviation|Mean
664479|NCT01785615|Primary|Mean Plasminogen Activator Inhibitor-1 in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|6 weeks|||ng/ml||Standard Deviation|Mean
664480|NCT01785615|Primary|Mean Soluble Vascular Adhesion Molecule in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|6 weeks|||ng/ml||Standard Deviation|Mean
664481|NCT01785615|Primary|Mean Soluble Intercellular Adhesion Molecule in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|6 weeks|||ng/ml||Standard Deviation|Mean
664482|NCT01785615|Primary|Mean Leptin in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|6 weeks|||pg/ml||Standard Deviation|Mean
664483|NCT01785615|Primary|Mean Alanine Aminotransferase in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|6 weeks|||units/L||Standard Deviation|Mean
664484|NCT01785615|Primary|Mean Aspartate Aminotransferase in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|6 weeks|||units/L||Standard Deviation|Mean
664485|NCT01785615|Primary|Mean Fasting Plasma Glucose in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|6 weeks|||mg/dl||Standard Deviation|Mean
664486|NCT01785615|Primary|Mean High Density Lipoprotein Cholesterol in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|6 weeks|||mg/dl||Standard Deviation|Mean
664487|NCT01785615|Primary|Mean Diastolic Blood Pressure|Measured with a blood pressure cuff|6 weeks|||mm Hg||Standard Deviation|Mean
664488|NCT01785615|Primary|Mean Systolic Blood Pressure|Measured with a blood pressure cuff|6 weeks|||mm Hg||Standard Deviation|Mean
664489|NCT01785615|Primary|Mean Waist Circumference|Waist circumference was measured with a ruler tape.|6 weeks|||inches||Standard Deviation|Mean
664689|NCT01782872|Secondary|Numeric Rating Scale (NRS) Pain Scores at Rest|Assessment of NRS pain scores (scale of 0-10; 0 = no pain, 10 = worst possible pain) at rest|Preop|||units on a scale||Inter-Quartile Range|Median
664490|NCT01785615|Primary|Mean High Sensitivity C-reactive Protein in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing. The ratio of Apo B to Apo A1 ratio was calculated|6 weeks|||ng/dl||Standard Deviation|Mean
664491|NCT01785615|Primary|Mean Apolipoprotein B/ Apolipoprotein A1 Ratio in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing. The ratio of Apo B to Apo A1 ratio was calculated.|6 weeks|||ratio||Standard Deviation|Mean
664492|NCT01785615|Primary|Mean Apolipoprotein B in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|6 weeks|||mg/dl||Standard Deviation|Mean
664493|NCT01785615|Primary|Mean Triglycerides in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|6 weeks|||mg/dl||Standard Deviation|Mean
664494|NCT01785615|Primary|Mean Low Density Lipoprotein Cholesterol in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|6 weeks|||mg/dl||Standard Deviation|Mean
664495|NCT01785602|Secondary|Change From Baseline in Eczema Area and Severity Index|Investigators assessed presence and severity of erythema, induration/papulation, excoriation, and lichenification in four body areas: head/neck (H), upper limbs (UL), trunk (T), and lower limbs (LL). Investigators assigned a severity score from 0 – 3 for each area (none=0, mild=1, moderate=2, and severe=3). Investigators could assign half-points. Investigators also assigned an area score from 0 (no atopic dermatitis lesion in the area) to 6 (entire area is affected) for each area. The weighting factor was 0.1 for head/neck, 0.2 for upper limbs, 0.3 for trunk, and 0.4 for lower limbs. The total body score for each body region was obtained by multiplying the sum of the severity scores of the four key signs by the area score, then multiplying the result by the constant weighted value assigned to that body region. The sum of these scores gave the EASI total, ranging from 0 to 72. A higher score represented greater disease severity. A negative change from baseline indicates improvement.|Baseline, 4 weeks, 8 weeks|All randomized participants||Score on a scale||Standard Error|Mean
664496|NCT01785602|Primary|Change From Baseline in Eczema Area and Severity Index (EASI)|Investigators assessed presence and severity of erythema, induration/papulation, excoriation, and lichenification in four body areas: head/neck (H), upper limbs (UL), trunk (T), and lower limbs (LL). Investigators assigned a severity score from 0 – 3 for each area (none=0, mild=1, moderate=2, and severe=3). Investigators could assign half-points. Investigators also assigned an area score from 0 (no atopic dermatitis lesion in the area) to 6 (entire area is affected) for each area. The weighting factor was 0.1 for head/neck, 0.2 for upper limbs, 0.3 for trunk, and 0.4 for lower limbs. The total body score for each body region was obtained by multiplying the sum of the severity scores of the four key signs by the area score, then multiplying the result by the constant weighted value assigned to that body region. The sum of these scores gave the EASI total, ranging from 0 to 72. A higher score represented greater disease severity. A negative change from baseline indicates improvement.|Baseline, 12 weeks|All randomized participants||Score on a scale||Standard Error|Mean
664497|NCT01785524|Secondary|Change In Vascular Function|Vascular Function will be measured as the Brachial artery flow-mediated dilation (BAFMD)|Baseline and 16 weeks|participants who completed study||change % dilation|||Number
664498|NCT01785524|Secondary|Change in Angiogenesis|Gastrocnemious muscle biopsy will be performed to measure the number of capillaries per fibre as a marker of change in angiogenesis between groups.|Baseline and 16 weeks|participants who underwent the gastrocnemius muscle biopsies||ratio of capillaries to muscle fibres||Standard Deviation|Mean
664499|NCT01785524|Secondary|Change in Functional Ability|Six-Minute Walk test. This test simple and practical assessment of functional capacity. The test measures the distance that a patient can walk on a flat, hard surface in a period of 6 minutes. The test is self-paced and assesses the submaximal level of functional capacity. The subjects choose their own intensity and are allowed to stop and rest if necessary during the test.|Baseline and 16 Weeks|||feet||Standard Deviation|Mean
664500|NCT01785524|Primary|Change in Exercise Capacity - Claudication Onset Time (COT)|Exercise capacity will be assessed using a maximal cardiopulmonary exercise (CPX) test for determination of Claudication Onset Time (COT)|Baseline & 16 Weeks|||seconds||Standard Deviation|Mean
664501|NCT01785524|Primary|Change in Exercise Capacity - Time to Exhaustion (TTE)|Exercise capacity will be assessed using a maximal cardiopulmonary exercise (CPX) test for determination of Time to Exhaustion (TTE)|Baseline & 16 Weeks|||seconds||Standard Deviation|Mean
664502|NCT01785524|Primary|Change in Exercise Capacity - Maximal Oxygen Capacity (VO2peak)|Exercise capacity will be assessed using a maximal cardiopulmonary exercise (CPX) test with expired gas analysis, for determination of peak oxygen consumption|Baseline & 16 Weeks|||ml/kg/min||Standard Deviation|Mean
664503|NCT01785472|Secondary|Number of Patients With Adverse Events, Serious Adverse Events, and Death as Assessment of Safety and Tolerability|Participants were monitored for adverse events, serious adverse events and deaths throughout the study.|baseline, 8 weeks|Safety Set (SAF): All patients who received at least one dose of double-blind trial medication. Patients were analyzed according to the treatment they received.||Participants|||Number
666043|NCT01763905|Secondary|Percent Change From Baseline in Apolipoprotein B at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
664504|NCT01785472|Secondary|Number of Responders|Responders are patients with msSBP response (<140 mmHg or ≥20 mmHg reduction from baseline) and msDBP response (<90 mmHg or ≥10 mmHg reduction from baseline)|baseline, 8 weeks|Participants from the full analysis set (FAS), who had both baseline and endpoint, were included in the analysis. The FAS included all participants who received study medication and had post baseline BP assessments||Participants|||Number
664505|NCT01785472|Secondary|Change From Baseline in Ambulatory Pulse Pressure|Ambulatory pulse pressure (PP) is calculated by hourly ambulatory SBP and hourly ambulatory DBP over a 24-hour period.|baseline, 8 weeks|Participants from the full analysis set (FAS), who had both baseline and endpoint, were included in the analysis. The FAS included all participants who received study medication and had post baseline BP assessments.||mmHg||Standard Error|Least Squares Mean
664506|NCT01785472|Secondary|Number of Patients Achieving Successful Blood Pressure Control|Successful blood pressure control is defined as msSBP <140 mmHg and msDBP <90 mmHg.|8 weeks|Participants from the full analysis set (FAS), who had both baseline and endpoint, were included in the analysis. The FAS included all participants who received study medication and had post baseline BP assessments.||Number of participants|||Number
664507|NCT01785472|Secondary|Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Non-dippers.|Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. Dippers were defined as participants who showed a decrease of at least 10% in maSBP during the night (10pm-6am) compared with the daytime level. A negative change from baseline indicates improvement|baseline, 8 weeks|A subset of participants, who participated in ambulatory blood pressure monitoring, was analyzed||mmHg||Standard Deviation|Mean
664508|NCT01785472|Secondary|Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Non-dippers.|Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. Dippers were defined as participants who showed a decrease of at least 10% in maSBP during the night (10pm-6am) compared with the daytime level. A negative change from baseline indicates improvement|baseline, 8 weeks|A subset of participants, who participated in ambulatory blood pressure monitoring, was analyzed||mmHg||Standard Deviation|Mean
664509|NCT01785472|Secondary|Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Dippers.|Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. Dippers were defined as participants who showed a decrease of at least 10% in maSBP during the night (10pm-6am) compared with the daytime level. A negative change from baseline indicates improvement|baseline, 8 weeks|A subset of participants, who participated in ambulatory blood pressure monitoring, was analyzed||mmHg||Standard Deviation|Mean
664510|NCT01785472|Secondary|Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Dippers.|Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. Dippers were defined as participants who showed a decrease of at least 10% in maSBP during the night (10pm-6am) compared with the daytime level. A negative change from baseline indicates improvement|baseline, 8 weeks|A subset of participants, who participated in ambulatory blood pressure monitoring, was analyzed||mmHg||Standard Deviation|Mean
664511|NCT01785472|Secondary|Change From Baseline in Mean 24-hour Ambulatory Blood Pressure|In this analysis, mean 24 hour ambulatory systolic blood pressure maSBP, mean 24 hour ambulatory diastolic blood pressure maDBP, daytime and nightime maSBP and maDBP will be reported. Ambulatory blood pressure monitoring over a 24 hour period will be conducted at two time points during the study.|baseline, 8 weeks|A subset of participants, who participated in ambulatory blood pressure monitoring, was analyzed||mmHg||Standard Error|Least Squares Mean
664512|NCT01785472|Secondary|Change From Baseline in Office Pulse Pressure (msPP)|Four separate sitting BP measurements should be obtained with a full two minute interval between measurements.|baseline, 8 weeks|Participants from the full analysis set (FAS), who had both baseline and endpoint were included in the analysis. The FAS included all participants who received study medication and had post baseline BP assessments||mmHg||Standard Error|Least Squares Mean
664513|NCT01785472|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) Between LCZ696 200, and LCZ696 400 mg Versus Olmesartan 20 mg|Sitting BP measurements were performed at screening through the end of the study at every study visit. A negative change from baseline indicates improvement|baseline, 8 weeks|Participants from the full analysis set (FAS), who had both baseline and week 8 values, were included in the analysis. The FAS included all participants who received study medication and had post baseline BP assessments||mmHg||Standard Error|Mean
664514|NCT01785472|Secondary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) Between LCZ696 400 mg Versus Olmesartan 20 mg|Sitting BP measurements will be performed at screening through end of study at every visit. Four separate sitting BP measurements will be obtained with a full two minute interval between measurements|baseline, 8 weeks|Only participants, who had both baseline and week 8 values, were included in the analysis. The FAS included all randomized participants who received study medication and had post baseline BP assessments||mmHg||Standard Error|Least Squares Mean
664515|NCT01785472|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) Between LCZ696 200 mg Versus Olmesartan 20 mg|Sitting BP measurements will be performed at screening through end of study at every visit. Four separate sitting BP measurements will be obtained with a full two minute interval between measurements.|baseline, 8 weeks|Only participants, who had both baseline and week 8 values, were included in the analysis. The FAS included all randomized participants who received study medication and had post baseline BP assessments||mmHg||Standard Error|Least Squares Mean
664516|NCT01785186|Secondary|Changes in Baseline Laboratory Safety Parameters During Treatment and Follow-up|Frequency tables will be generated for visual acuity tests, 12 lead ECGs, clinical chemistry metrics, haematology, and urinalysis|0 - 12 weeks||||||
664517|NCT01785186|Secondary|Occurence of Treatment Failure (Relapse or Emergence of Drug-resistance)|Frequency of treatment failures (number of patients with relapse and/or development of drug resistance) will be recorded|0 - 12 weeks||||||
664518|NCT01785186|Secondary|Rate of Change in Quantitative PCR During Therapy|GeneXpert MTB/RIF (Xpert) quantitative PCR results (counts per week|0 - 12 weeks||||||
664522|NCT01785186|Secondary|Pharmacodynamics Including AUC0‐24/MIC (h*ng/mL) and Cmax/MIC (ng/mL)|By combining pharmacokinetic parameters and MIC values (see below), the pharmacodynamic indices AUC0‐24/MIC (h*ng/mL) and Cmax/MIC (ng/mL) will be calculated for individual patients for experimental drugs administered. Pharmacokinetic parameters and pharmacodynamic indices will be related to efficacy and safety/tolerability endpoints.|0 - 12 weeks||||||
664523|NCT01785186|Secondary|Pharmacokinetics Including AUC, Cl, t1/2, Vd, and Protein Binding|"Pharmacokinetic parameters will be assessed for rifampicin, moxifloxacin and SQ109:
area under the plasma concentration curve from dosing to the end of the dosing interval (AUC 0‐24) (in h*ng/mL)
the observed maximum concentration (Cmax( (in ng/mL)
time to reach Cmax (Tmax)(in hours)
the minimum observed plasma concentration 24 hours following the last dose (Cmin) (in hours),
clearance (Cl) (in mL/minute),
volume of distribution (Vd) (in L),
elimination half‐life (T1/2,) (in hours)
free (protein‐unbound) fraction (for rifampicin only) (in percent)."|0 - 12 weeks|Pharmacokinetic population||Rifampicin AUC(mg*h/l)||Full Range|Geometric Mean
664524|NCT01785186|Secondary|Mycobacteriology Identification and Characterization by PCR and MIC|"Cultures grown from the screening period, and the last sputum sample with mycobacteriological growth will be assessed as follows:
Identification of M. tuberculosis complex and RIF resistance by PCR (GeneXpert MTB/RIF®),
First-line drug susceptibility testing of the M. tuberculosis isolates using the MGIT system for sensitivity to rifampicin; isoniazid, pyrazinamide, moxifloxacin or ethambutol.
Minimum inhibitory concentrations (MIC) of SQ109, rifampicin and moxifloxacin.
Typing of the infecting strain(s) by molecular methods."|0 - 12 weeks||||||
664525|NCT01785186|Secondary|Frequency of Adverse Events|All Adverse Events (AE), and AEs considered to be drug-related will coded using standard AE dictionaries.|0 - 12 weeks|||participants|||Number
664526|NCT01785186|Primary|Sputum Culture Conversion (2 Negative Cultures) Using Liquid Media|From enrollment, the time to stable culture conversion (2 consecutive negative weekly cultures) in liquid media.|0 - 12 weeks|Modified intention to treat analysis||days||Inter-Quartile Range|Median
664527|NCT01785160|Primary|Cmax ,ss|"C max,ss (maximum measured concentration of the Raltegravir in plasma at steady state) Point estimates for the intrasubject ratio of the geometric means (for treatments Test and Reference) of Cmax,ss and their 2-sided 90% confidence intervals (CI) were calculated.
The statistical model was an analysis of variance (ANOVA) on log-transformed parameters including effects for ‘subject’ and ‘treatment’.
RAL: Raltegravir , FDV: Faldaprevir"|0.5 hours (h) before drug administration and 48 hours (h),60,72,72.5,73,73.5,74,75,76,77,78,80,82 and 84(hours) after administration of RAL alone; 96 h,108,120,120.5,121,121.5,122,123,124, 125,126,128,130 and 132hours after RAL and FDV administration|Pharmacokinetic(PK) set:Subjects who received atleast 1 dose of study medication and who provided at least 1 observation for at least 1 PK endpoint without any important protocol violations relevant to the evaluation of relative bioavailability and did not experience emesis at or before 2 times median tmax on the pk study days of both trial periods||ng/mL||Geometric Coefficient of Variation|Geometric Mean
664528|NCT01785160|Primary|AUC( Tau,ss)|"AUC tau,ss (area under the concentration-time curve of the Raltegravir in plasma at steady state over the uniform dosing interval tau) Point estimates for the intrasubject ratio of the geometric means (for treatments Test and Reference) of AUC tau,ss and their 2-sided 90% confidence intervals (CI) were calculated.
The statistical model was an analysis of variance (ANOVA) on log-transformed parameters including effects for ‘subject’ and ‘treatment’.
RAL: Raltegravir , FDV: Faldaprevir"|0.5 hours (h) before drug administration and 48 hours (h),60,72,72.5,73,73.5,74,75,76,77,78,80,82 and 84(hours) after administration of RAL alone; 96 h,108,120,120.5,121,121.5,122,123,124, 125,126,128,130 and 132 hours after RAL and FDV administration|Pharmacokinetic(PK) set:Subjects who received atleast 1 dose of study medication and who provided at least 1 observation for at least 1 PK endpoint without any important protocol violations relevant to the evaluation of relative bioavailability and did not experience emesis at or before 2 times median tmax on the pk study days of both trial periods||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
664529|NCT01785134|Secondary|Blood Lipids||2 years postoperative|||P-Cholesterol mmol/L||Standard Deviation|Mean
664530|NCT01785134|Secondary|Body Mass Index at 2 Years||2 years postoperative|||Kg/meter squared||Standard Deviation|Mean
664531|NCT01785134|Secondary|Blood Pressure at 2 Years||2 years postoperative|||mm Hg systolic||Standard Deviation|Mean
664532|NCT01785134|Secondary|Body Composition at Two Years||2 years postoperative|||% body fat||Standard Deviation|Mean
664533|NCT01785134|Primary|Insulin Sensitivity at 2 Years|Insulin sensitivity measured by hyperinsulinemic euglycemic clamp|2 years postoperative|||glucose/kg body weight/min||Standard Deviation|Mean
664534|NCT01785095|Secondary|Total Dose of FSH Units Used.||after 2 weeks of treatment|||IU||Standard Deviation|Mean
664535|NCT01785095|Secondary|Number of Oocytes Retrieved|the number of oocytes retrieved in the first cycle and in the second cycle are compared.|after 2 weeks of treatment|||oocytes||Standard Deviation|Mean
664536|NCT01785095|Primary|Number of Patients Producing Anti-FSH Antibodies.|The immunogenicity potential of FSH in healthy volunteer will be assessed by analysing serum samples collected at different timepoints during two treatment cycle for oocytes donation: cycle 1, serum samples will be collected before treatment start (baseline), after 7-13 days and after 28 days of treatment; Cycle 2: serum samples will be collected before starting the second cycle (baseline 2), after 7-13 days and after 28 days of treatment. Cycle 1 and cycle 2 will be separated by a wash-out period of two months.|4 months.|presence of Antibodies against FSH||participants|||Number
664537|NCT01784965|Secondary|Insulin Resistance in the Liraglutide vs.Placebo Group After Calorie Restriction|Mean (+/- SD) change in insulin resistance associated with caloric restriction plus liraglutide vs. caloric restriction and placebo.|Baseline, 14 weeks|||mg/dL||Standard Deviation|Mean
664538|NCT01784965|Secondary|Glucose-stimulated Insulin Secretion in Insulin AUC, Pmol/1x 4H|Absolute change in glucose-stimulated insulin secretion (GS-IS) associated with caloric restriction plus liraglutide vs. caloric restriction and placebo at 14 weeks|Baseline, 14 weeks|||pmol/l x4 h||95% Confidence Interval|Mean
664539|NCT01784965|Primary|Change in Weight Reported at 14 Weeks|Change in weight with caloric restriction plus liraglutide vs. caloric restriction and placebo over 14 weeks.|Baseline and 14 weeks|||kg||95% Confidence Interval|Mean
664982|NCT01777945|Secondary|Number of Participants With Adverse Events||approximately 2 years|46 participants enrolled in the study were evaluable with regards to tolerability; however, 1 participant did not meet the eligibility criteria, was excluded from the efficacy analyses, but was included in the safety analyses.||participants|||Number
664540|NCT01784666|Primary|Change in MADRS (4 Weeks)|"Change in Montgomery-Asberg Depression Rating Scale (MADRS) in isradipine-treated epochs versus placebo-treated epochs.
These scores represent total scores, and on the MADRS total scores range from 0-60. A higher score indicates increased depression severity."|Baseline vs week 4 (and, for placebo nonresponders in 1st 4 weeks, week 8 vs week 4)|||scores on a scale|||Number
664541|NCT01784614|Secondary|PK: Area Under the Concentration-Time Curve From Time 0 to Infinity [AUC(0-∞)] of LY2624803 After Single Oral Dose in Period 4||Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 10, 12, 18, and 42 hours post-dose in Period 4|All randomized participants who received a single oral dose of LY2624803 in Period 4 and had evaluable PK data.||nanograms•hour/milliliter (ng•hr/mL)||Geometric Coefficient of Variation|Geometric Mean
664542|NCT01784614|Secondary|PK: Maximum Plasma Concentration (Cmax) of LY2624803 After Single Oral Dose in Period 4||Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 10, 12, 18, and 42 hours post-dose in Period 4|All randomized participants who received a single oral dose of LY2624803 in Period 4 and had evaluable PK data.||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
664543|NCT01784614|Secondary|Total Sleep Time (TST)|TST is defined as the total time in sleep epochs from sleep onset time to the end of the primary recording period (8 hours after lights -off). LS mean was calculated using mixed models analysis. The model included factors for treatment, treatment sequence, period and participants.|8 hours in Periods 1, 2 and 3|All randomized participants who received at least 1 dose of study drug and had PSG measurements in Periods 1, 2 and 3.||min||90% Confidence Interval|Least Squares Mean
664544|NCT01784614|Secondary|Latency to Persistent Sleep (LPS)|LPS is defined as the latency from the lights-off time to the first stage 2 sleep followed by at least 10 consecutive minutes of sleep epochs. Data presented are Geometric LS means. Geometric LS mean was calculated using mixed models analysis. The model included factors for treatment, treatment sequence, period and participants.|8 hours in Periods 1, 2 and 3|All randomized participants who received at least 1 dose of study drug and had PSG measurements in Periods 1, 2 and 3.||min||90% Confidence Interval|Geometric Mean
664545|NCT01784614|Primary|Wake After Sleep Onset (WASO) With LY2624803 Compared to Placebo|WASO was calculated as total time in awake epochs between sleep onset time (first stage 2 epoch) and the end of the primary recording period (8 hours after lights -off). Data presented are Geometric Least Squares (LS) means. Geometric LS mean was calculated using mixed models analysis. The model included factors for treatment, treatment sequence, period and participants.|8 hours in Periods 1, 2 and 3|All randomized participants who received at least 1 dose of study drug and had PSG measurements in Periods 1, 2 and 3.||minutes (min)||90% Confidence Interval|Geometric Mean
664546|NCT01783938|Secondary|Investigator-assessed Rate of Progression|The progression rate at a specific timepoint is defined as the number of participants who have Progressive Disease (PD) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 at that specific timepoint divided by the total number of randomized participants. As specified by modified RECIST 1.1, the evaluation of PD at Week 13 and Week 25 used the baseline tumor assessment as reference. For purposes of the primary analysis of progression rates, if a treated participant were missing his/her tumor assessment at the specified study week, then the results of the previous tumor response evaluation were to be carried forward. Both clinical and radiological progressions were counted as a progression outcome. A participant who died without a reported prior progression was considered to have progressed on the date of his/her death. Deaths before or at Week 13 are counted as progression outcome. Confidence interval based on the Clopper and Pearson method.|Week 13; Week 25|All treated participants; All participants who received at least one dose of any study therapy.||percentage of participants||95% Confidence Interval|Number
664547|NCT01783938|Secondary|Investigator-assessed Duration of Response (DOR)|Duration of response (DOR) was performed to further characterize the response rate at Week 25. Duration of response is defined as the time between the Week 25 date of response and the date of objectively documented disease progression as defined by modified RECIST 1.1 criteria or death, whichever occurs first. DOR was assessed for participants with confirmed response at Week 25. Median computed using Kaplan-Meier product-limit method.|Week 25 up to date of disease progression or death, up to approximately 2 years|All treated participants with confirmed response at week 25; Participants were censored at their last assessment date if response was not changed.||months||95% Confidence Interval|Median
664548|NCT01783938|Secondary|Investigator-assessed Response Rate at Week 25|Response rate is defined as the number of participants who have a complete response (CR) or partial response (PR) at Week 25 per modified RECIST 1.1 criteria, with confirmation on the scheduled scan at Week 33 (or any subsequent scan performed at least 4 weeks after the Week 25 scan), divided by the total number of treated participants. Results of the tumor assessment at Week 13 or any unscheduled tumor assessment obtained prior to Week 25, except for baseline/screening tumor assessment, were not considered in the assessment of response rate at Week 25. Any treated participant without an evaluable Week 25 time point response (per modified RECIST 1.1) was considered a non-responder for primary analysis of response rate at Week 25. Evaluations occurring after the dates of subsequent anticancer therapy were not included when determining or confirming response at Week 25. Confidence interval based on the Clopper and Pearson method.|Week 25|All treated participants; All participants who received at least one dose of any study therapy.||percentage of participants||95% Confidence Interval|Number
664549|NCT01783938|Primary|Percentage of Participants With Treatment-related Grade 3-5 Adverse Events (AEs) During the Induction Periods|The rate or percentage of participants with treatment-related grade 3-5 AEs is defined as the number of participants who experienced at least 1 treatment related Grade 3 - 5 adverse event (AE) per NCI CTCAE version 4.0 criteria, any preferred term with an onset date after or on first day of Induction Period #1 and not later than discontinuation date from Induction Period #2, divided by the total number of treated participants. AEs with an onset date after start date of Continuation Period or start of subsequent anti-cancer therapy were not included. Adverse Event (AE)=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may or may not have a causal relationship with treatment. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Potentially Life-threatening or disabling, Gr 5=Death.|Day 1 up to Week 25|All treated participants; All participants who received at least one dose of any study therapy.||percentage of participants||95% Confidence Interval|Number
664550|NCT01783912|Primary|Acceptance of Wisconsin Tobacco Quit Line Services|The primary outcome is participant acceptance of evidence based treatment through the WTQL at the end of the last individual session.|4-6 weeks after study enrollment|||participants|||Number
664551|NCT01783886|Secondary|Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Distance Activities Subscale at Week 52 - LOCF|The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales that are all scored from 0-100. Distance activities are defined as reading street signs or names on stores, and going down stairs, steps, or curbs.|Baseline up to week 52|FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
664552|NCT01783886|Secondary|Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Near Activities Subscale at Week 52 - LOCF|The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales that are all scored from 0-100. Near activities are defined as reading ordinary print in newspapers, performing work or hobbies requiring near vision, or finding something on a crowded shelf.|Baseline up to week 52|FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
664553|NCT01783886|Secondary|Change From Baseline in Central Retinal Thickness (CRT) at Week 52 as Assessed on Optical Coherence Tomography (OCT) - LOCF|CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from Baseline indicated improvement.|Baseline up to week 52|FAS with assessment for this outcome measure.||micrometer||Standard Deviation|Mean
664554|NCT01783886|Secondary|Percentage of Participants With a Greater Than Equal (>=) Two-step Improvement From Baseline in the ETDRS Diabetic Retinopathy Severity Score (DRSS) as Assessed by Fundus Photography (FP) at Week 52 - LOCF|ETDRS DRSS: None (level 10); Mild to moderate nonproliferative diabetic retinopathy (DR) (levels 14, 15, 20, 35, and 43); Moderately severe/severe nonproliferative DR (levels 47 and 53); Mild/moderate/high-risk/advanced proliferative DR (levels 61, 65, 71,75, 81, and 85)|Baseline up to week 52|FAS.||Percentage of participants|||Number
664555|NCT01783886|Secondary|Percentage of Participants Who Gained at Least 15 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF|Visual function of the study eye was assessed using the ETDRS protocol. A higher score represents better functioning.|Baseline up to week 52|FAS.||Percentage of participants|||Number
664556|NCT01783886|Secondary|Percentage of Participants Who Gained at Least 10 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF|Visual function of the study eye was assessed using the ETDRS protocol. A higher score represents better functioning.|Baseline up to week 52|FAS.||Percentage of participants|||Number
664557|NCT01783886|Primary|Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 52 - Last Observation Carried Forward (LOCF)|Visual function of the study eye was assessed using the ETDRS protocol, which is a widely accepted international standard for macular laser photocoagulation treatment. A higher score represents better functioning. LOCF censored measurements after additional treatment.|Baseline up to week 52|Full analysis set (FAS) included all randomized participants who received any study treatment, had a baseline measurement of BCVA, and had at least 1 post-baseline assessment of BCVA. FAS with assessment for this outcome measure.||Letters correctly read||Standard Deviation|Mean
664558|NCT01783860|Other Pre-specified|Change of Total Severity Score Between Baseline and 37 Days Later|Total severity score was a combined score of symptoms and signs. For symptoms, there were five items and for signs there were seven items. Each items had three scales form Zero (no symptom) to three (severe symptom). Therefore, there was 12 items to calculate total severity score. Maximum score was 36 (worse outcome) and minimum score was zero (better outcome). A change in total severity score calculated as the latest time period (37 days) minus earliest time point.|baseline and 37 days later|||units on a scale||Standard Deviation|Mean
664559|NCT01783860|Other Pre-specified|Change of Total Severity Score Between Baseline and 31 Days Later|Total severity score was a combined score of symptoms and signs. For symptoms, there were five items and for signs there were seven items. Each items had three scales form Zero (no symptom) to three (severe symptom). Therefore, there was 12 items to calculate total severity score. Maximum score was 36 (worse outcome) and minimum score was zero (better outcome). A change in total severity score calculated as the latest time period (31 days) minus earliest time point.|baseline and 31 days later|||units on a scale||Standard Deviation|Mean
664560|NCT01783860|Other Pre-specified|Change of Total Severity Score Between Baseline and 7 Days Later|Total severity score was a combined score of symptoms and signs. For symptoms, there were five items and for signs there were seven items. Each items had three scales form Zero (no symptom) to three (severe symptom). Therefore, there was 12 items to calculate total severity score. Maximum score was 36 (worse outcome) and minimum score was zero (better outcome). A change in total severity score calculated as the latest time period (7 days) minus earliest time point.|baseline and 7 days later|||units on a scale||Standard Deviation|Mean
664561|NCT01783860|Primary|Change of Symptoms and Signs Scores (Difference Between Total Score of First Time and 61 Days Later), Total Severity Score|Total severity score was a combined score of symptoms and signs. For symptoms, there were five items and for signs there were seven items. Each items had three scales form Zero (no symptom) to three (severe symptom). Therefore, there was 12 items to calculate total severity score. Maximum score was 36 (worse outcome) and minimum score was zero (better outcome). A change in total severity score calculated as the latest time period (61 days) minus earliest time point.|zero time and 61 days later|||units on a scale||Standard Deviation|Mean
664562|NCT01783860|Secondary|Main Ocular Signs|lid margin debris, lid margin redness, Meibomian gland (MG) secretion, occluded MG, conjunctival redness, tear brake up time and ocular surface staining at Baseline, and days 7, 31, 37 and 61 after treatment were measured. For each items there was a question with scale form zero to three (zero for no sign to three for maximum sign). Therefore, maximum score for signs was 21 (worse outcome) and minimum score was zero (better outcome). We calculated a total score for signs. Finally, we reported a change in total score calculated as the latest time point (61 days) minus earliest time point.|Change from baseline until 61 days after treatment|||units on a scale||Standard Deviation|Mean
664614|NCT01783483|Secondary|Narcotic Usage|Narcotics usage was tabulated and recorded at each follow-up interval and converted to Morphine Equivalence Dose (MED) .|From 6-week to 3-month post-op|Subjects with completed narcotic usage assessment from 6-week to 3-month post op: 108 Suture Wire / 104 SternaLock Blu||milligrams of Morphine Equivalence Dose||Standard Deviation|Mean
664563|NCT01783860|Primary|Change of Blepharitis Symptoms Score|Five main ocular symptoms of posterior blepharitis (itching, foreign body sensation, dryness, burning, and lid swelling) will be asked of each patient and graded at baseline, and days 7, 31, 37 and 61 after treatment. For each item there was a question with scale from zero to three (zero for no symptom three for maximum symptom). Therefore, maximum score for symptoms was 15 (worse outcome) and minimum score for symptoms was zero (better outcome). Finally, we reported a change in total score calculated as the latest time point (61 days) minus the earliest time point.|Change from the baseline until 61 days after treatment|||score||Standard Deviation|Mean
664564|NCT01783821|Secondary|Intensive Care Unit (ICU) Length of Stay||Baseline to Day 28|||days||Inter-Quartile Range|Median
664565|NCT01783821|Secondary|Hospital Length of Stay||Baseline to Day 28|||days||Inter-Quartile Range|Median
664566|NCT01783821|Secondary|Number of Subjects Who Developed Acute Respiratory Distress Syndrome (ARDS)|ARDS was defined per Berlin definition. Chest radiographs of all ventilated (non-invasive or invasive) patients were reviewed as consistent or not consistent with ARDS by the site investigator. A second adjudication was performed by an alternate principal investigator blinded to subject identification and clinical data. Final diagnosis of ARDS was determined centrally after chest radiograph adjudication was considered together with other relevant clinical data.|Hospital discharge, approximately day 28|||participants|||Number
664567|NCT01783821|Secondary|Number of Subjects Who Needed Mechanical Ventilation||Hospital discharge, approximately day 28|||participants|||Number
664568|NCT01783821|Primary|Number of Participants Experiencing Categorical Change in Oxygen Saturation to Fraction of Inspired Oxygen Concentration (SpO2/FiO2) Ratio|The data in the table below represent the greatest change from baseline observed for any one participant over all individual post-baseline measurements.|Days 0 - 5|Intention to Treat Analysis||participants|||Number
664569|NCT01783821|Primary|Change in Oxygen Saturation to Fraction of Inspired Oxygen Concentration (SpO2/FiO2) Ratio|Oxygen saturation (SpO2) was measured by pulse oximetry. FiO2 is the assumed proportion of oxygen concentration participating in gas exchange in the alveoli. All S/F measurements were performed per standard operating protocol using a Venturi mask titrated to obtain an oxygen saturation of 94 ± 2% unless the patient met this goal on room air or clinical status dictated an alternative delivery mode. This outcome measure was analyzed as a longitudinal continuous variable by a mixed effect model. The formula for the calculation of SpO2/FiO2 (or S/F ratio) is %saturation/proportion of FiO2 concentration.|baseline to day 5 after the first treatment|Intention to Treat analysis. The patient population for each day is indicated in the category by (treatment arm, placebo arm).||SpO2/FiO2 Ratio||Inter-Quartile Range|Median
664570|NCT01783730|Secondary|Percentage of Participants Achieving SDAI Remission|The SDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global disease activity assessed by the participant on a visual analogue scale from 0 to 10 (cm) , global disease activity assessed by an investigator on a visual analogue scale from 0 to 10 (cm), and serum levels of C-reactive protein (mg/dL) were included in the SDAI score. Scores on the SDAI range from 0 to 86. An SDAI score ≥26.1 indicates high disease activity, an SDAI score between 11.1 and 26.0 indicates moderate disease activity, an SDAI score between 3.4 and 11.0 indicates low disease activity, and an SDAI score ≤3.3 indicates clinical remission. The percentage of participants with an SDAI score ≤3.3 was documented.|From baseline to 24 weeks|Participants with available data||percentage of participants|||Number
664571|NCT01783730|Secondary|Mean Simplified Disease Activity Index (SDAI) Score at Week 24|The SDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global disease activity assessed by the participant on a visual analogue scale from 0 to 10 (cm) , global disease activity assessed by an investigator on a visual analogue scale from 0 to 10 (cm), and serum levels of C-reactive protein (mg/dL) were included in the SDAI score. Scores on the SDAI range from 0 to 86. An SDAI score ≥26.1 indicates high disease activity, an SDAI score between 11.1 and 26.0 indicates moderate disease activity, an SDAI score between 3.4 and 11.0 indicates low disease activity, and an SDAI score ≤3.3 indicates clinical remission.|at week 24|Participants with available data||units on a scale||Standard Deviation|Mean
664572|NCT01783730|Secondary|Mean Simplified Disease Activity Index (SDAI) Score at Week 12|The SDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global disease activity assessed by the participant on a visual analogue scale from 0 to 10 (cm) , global disease activity assessed by an investigator on a visual analogue scale from 0 to 10 (cm), and serum levels of C-reactive protein (mg/dL) were included in the SDAI score. Scores on the SDAI range from 0 to 86. An SDAI score ≥26.1 indicates high disease activity, an SDAI score between 11.1 and 26.0 indicates moderate disease activity, an SDAI score between 3.4 and 11.0 indicates low disease activity, and an SDAI score ≤3.3 indicates clinical remission.|at week 12|Participants with available data||units on a scale||Standard Deviation|Mean
664573|NCT01783730|Secondary|Mean Simplified Disease Activity Index (SDAI) Score at Week 4|The SDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global disease activity assessed by the participant on a visual analogue scale from 0 to 10 (cm) , global disease activity assessed by an investigator on a visual analogue scale from 0 to 10 (cm), and serum levels of C-reactive protein (mg/dL) were included in the SDAI score. Scores on the SDAI range from 0 to 86. An SDAI score ≥26.1 indicates high disease activity, an SDAI score between 11.1 and 26.0 indicates moderate disease activity, an SDAI score between 3.4 and 11.0 indicates low disease activity, and an SDAI score ≤3.3 indicates clinical remission.|at week 4|Participants with available data||units on a scale||Standard Deviation|Mean
664574|NCT01783730|Secondary|Mean Simplified Disease Activity Index (SDAI) Score at Baseline|The SDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global disease activity assessed by the participant on a visual analogue scale from 0 to 10 (cm) , global disease activity assessed by an investigator on a visual analogue scale from 0 to 10 (cm), and serum levels of C-reactive protein (mg/dL) were included in the SDAI score. Scores on the SDAI range from 0 to 86. An SDAI score ≥26.1 indicates high disease activity, an SDAI score between 11.1 and 26.0 indicates moderate disease activity, an SDAI score between 3.4 and 11.0 indicates low disease activity, and an SDAI score ≤3.3 indicates clinical remission.|at week 0|Participants with available data||units on a scale||Standard Deviation|Mean
664983|NCT01777945|Secondary|Percentage of Capecitabine Dose Modifications||approximately 2 years|||percentage of doses|||Number
664575|NCT01783730|Secondary|Percentage of Participants Achieving CDAI Remission|The CDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global health assessed by the participant on a visual analogue scale from 0 to 10 (cm) , and global health assessed by an investigator on a visual analogue scale from 0 to 10 (cm) were included in the CDAI score. Scores on the CDAI range from 0 to 76. A CDAI score ≥22.1 indicates high disease activity, a CDAI score between 10.1 and 22.0 indicates moderate disease activity, a CDAI score between 2.9 and 10.0 indicates low disease activity, and a CDAI score ≤2.8 indicates clinical remission. The percentage of participants with a CDAI score ≤2.8 was documented.|From baseline to 24 weeks|Participants with available data||percentage of participants|||Number
664576|NCT01783730|Secondary|Mean Clinical Disease Activity Index (CDAI) Score at Week 24|The CDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global health assessed by the participant on a visual analogue scale from 0 to 10 (cm), and global health assessed by an investigator on a visual analogue scale from 0 to 10 (cm) were included in the CDAI score. Scores on the CDAI range from 0 to 76. A CDAI score ≥22.1 indicates high disease activity, a CDAI score between 10.1 and 22.0 indicates moderate disease activity, a CDAI score between 2.9 and 10.0 indicates low disease activity, and a CDAI score ≤2.8 indicates clinical remission.|at week 24|Participants with available data||units on a scale||Standard Deviation|Mean
664577|NCT01783730|Secondary|Mean Clinical Disease Activity Index (CDAI) Score at Week 12|The CDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global health assessed by the participant on a visual analogue scale from 0 to 10 (cm), and global health assessed by an investigator on a visual analogue scale from 0 to 10 (cm) were included in the CDAI score. Scores on the CDAI range from 0 to 76. A CDAI score ≥22.1 indicates high disease activity, a CDAI score between 10.1 and 22.0 indicates moderate disease activity, a CDAI score between 2.9 and 10.0 indicates low disease activity, and a CDAI score ≤2.8 indicates clinical remission.|at week 12|Participants with available data||units on a scale||Standard Deviation|Mean
664578|NCT01783730|Secondary|Mean Clinical Disease Activity Index (CDAI) Score at Week 4|The CDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global health assessed by the participant on a visual analogue scale from 0 to 10 (cm), and global health assessed by an investigator on a visual analogue scale from 0 to 10 (cm) were included in the CDAI score. Scores on the CDAI range from 0 to 76. A CDAI score ≥22.1 indicates high disease activity, a CDAI score between 10.1 and 22.0 indicates moderate disease activity, a CDAI score between 2.9 and 10.0 indicates low disease activity, and a CDAI score ≤2.8 indicates clinical remission.|at week 4|Participants with available data||units on a scale||Standard Deviation|Mean
664579|NCT01783730|Secondary|Mean Clinical Disease Activity Index (CDAI) Score at Baseline|The CDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global health assessed by the participant on a visual analogue scale from 0 to 10 (cm), and global health assessed by an investigator on a visual analogue scale from 0 to 10 (cm) were included in the CDAI score. Scores on the CDAI range from 0 to 76. A CDAI score ≥22.1 indicates high disease activity, a CDAI score between 10.1 and 22.0 indicates moderate disease activity, a CDAI score between 2.9 and 10.0 indicates low disease activity, and a CDAI score ≤2.8 indicates clinical remission.|at week 0|Participants with available data||units on a scale||Standard Deviation|Mean
664580|NCT01783730|Secondary|Percentage of Participants Achieving DAS28-4(ESR) Remission|The DAS28-4(ESR) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR), and general health were included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission. The percentage of participants with a DAS28 score <2.6 was documented.|From baseline to 24 weeks|Participants with available data||percentage of participants|||Number
664581|NCT01783730|Secondary|Mean Disease Activity Score 28 (DAS28-4(ESR)) at Week 24|The DAS28-4(ESR) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR), and general health were included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.|at week 24|Participants with available data||units on a scale||Standard Deviation|Mean
664582|NCT01783730|Secondary|Mean Disease Activity Score 28 (DAS28-4(ESR)) at Week 12|The DAS28-4(ESR) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR), and general health were included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission .|at week 12|Participants with available data||units on a scale||Standard Deviation|Mean
664583|NCT01783730|Secondary|Mean Disease Activity Score 28 (DAS28-4(ESR)) at Week 4|The DAS28-4(ESR) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR), and general health were included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission .|at week 4|Participants with available data||units on a scale||Standard Deviation|Mean
664584|NCT01783730|Secondary|Mean Disease Activity Score 28 (DAS28-4(ESR)) at Baseline|The DAS28-4(ESR) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR), and general health were included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.|at week 0|Participants with available data||units on a scale||Standard Deviation|Mean
664615|NCT01783483|Secondary|Narcotic Usage|Narcotics usage was tabulated and recorded at each follow-up interval and converted to Morphine Equivalence Dose (MED) .|From 3-week to 6-week post-op|Subjects with completed narcotic usage assessment from 3-week to 6-week post op: 115 Suture Wire / 111 SternaLock Blu||milligrams of Morphine Equivalence Dose||Standard Deviation|Mean
664984|NCT01777945|Secondary|Duration of Treatment With Xeloda||approximately 2 years|||treatment cycle||Standard Deviation|Mean
664585|NCT01783730|Primary|Number of Participants With Adverse Events|An adverse event (AE) is defined as any untoward medical occurrence in a patient which does not necessarily have a causal relationship with their treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not the event is considered causally related to the use of the product. Adverse events were collected from the time of informed consent until the completion of the study, up to 26 weeks.|From baseline through week 26|Participants who received adalimumab treatment||participants|||Number
664586|NCT01783678|Secondary|Percentage of Participants Experiencing Virologic Failure|"On-treatment virologic failure was defined as either:
Virologic breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
Nonresponse (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment).
Virologic relapse was defined as confirmed HCV RNA ≥ LLOQ during the posttreatment period, having achieved HCV RNA < LLOQ at last on-treatment visit."|Baseline up to Posttreatment Week 24|Full Analysis Set. 1 participant with genotype 1 HCV infection did not have subtype information available.||percentage of participants|||Number
664587|NCT01783678|Secondary|HCV RNA Change From Baseline at Week 8||Baseline; Week 8|Participants in the Full Analysis Set with available data were analyzed. 1 participant with genotype 1 HCV infection did not have subtype information available.||log10 IU/mL||Standard Deviation|Mean
664588|NCT01783678|Secondary|HCV RNA Change From Baseline at Week 6||Baseline; Week 6|Participants in the Full Analysis Set with available data were analyzed. 1 participant with genotype 1 HCV infection did not have subtype information available.||log10 IU/mL||Standard Deviation|Mean
664589|NCT01783678|Secondary|HCV RNA Change From Baseline at Week 4||Baseline; Week 4|Participants in the Full Analysis Set with available data were analyzed. 1 participant with genotype 1 HCV infection did not have subtype information available.||log10 IU/mL||Standard Deviation|Mean
664590|NCT01783678|Secondary|HCV RNA Change From Baseline at Week 2||Baseline; Week 2|Participants in the Full Analysis Set with available data were analyzed. 1 participant with genotype 1 HCV infection did not have subtype information available.||log10 IU/mL||Standard Deviation|Mean
664591|NCT01783678|Secondary|HCV RNA Change From Baseline at Week 1||Baseline; Week 1|Participants in the Full Analysis Set with available data were analyzed. 1 participant with genotype 1 HCV infection did not have subtype information available.||log10 IU/mL||Standard Deviation|Mean
664592|NCT01783678|Secondary|Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 were defined as HCV RNA < the lower limit of quantitation (LLOQ) 4 weeks and 24 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set. 1 participant with genotype 1 HCV infection did not have subtype information available.||percentage of participants|||Number
664593|NCT01783678|Primary|Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)|The percentage of participants permanently discontinuing any study drug due to an adverse event was summarized.|Up to 24 weeks|Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug||percentage of participants|||Number
664594|NCT01783678|Primary|Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ, ie, < 25 IU/mL) 12 weeks following the last dose of study drug.|Posttreatment Week 12|Full Analysis Set: participants who were randomized and received at least 1 dose of study drug. 1 participant with genotype 1 HCV infection did not have subtype information available.||percentage of participants|||Number
664595|NCT01783639|Secondary|Procedural Success|Defined as both device and angiographic success|Participants will be followed for the duration of the procedure, an expected average of 35 minutes||||||
664596|NCT01783639|Secondary|Angiographic Success|Successful completion of the protected stent procedure without angiographic complications|Participants will be followed for the duration of the procedure, an expected average of 35 minutes||||||
664597|NCT01783639|Secondary|Neurological Events Occurring Within 30 Days Post Procedure,Including Strokes and Transient Ischemic Attacks||Within 30 Days of procedure||||||
664598|NCT01783639|Secondary|The Rate of Access Site Complications||Within 30 Days of procedure||||||
664599|NCT01783639|Secondary|The Rate of Clinical Success|Defined as freedom from procedure related serious adverse events|Participants will be followed for the duration of the procedure, an expected average of 35 minutes||||||
664600|NCT01783639|Secondary|The Rate of Device Success|Defined as a successful delivery, deployment and retrieval of WIRION™ without any complications|Participants will be followed for the duration of the procedure, an expected average of 35 minutes||||||
664601|NCT01783639|Primary|The Rate of Peri-procedural (Within 30 Days of Procedure) Death, Stroke, and Myocardial Infarction.|Each participant will be followed for 30 days of procedure during which the number of major cardiac and cerebral adverse events (Stroke, Death and Myocardial Infraction) will be counted to evaluate the device safety.|Within 30 Days of procedure|||participants||95% Confidence Interval|Number
664602|NCT01783561|Secondary|Cerebral Blood Flow|To determine if a loading dose of intravenous caffeine administered to preterm infants (< 29 weeks) within the first 2 hours of life compared to 12 hours of life results in improved cerebral blood flow by near infrared spectroscopy (NIRS) in the first 24 hours of life.|first 24 hours of life||||||
664603|NCT01783561|Secondary|Systemic Blood Flow|To determine if a loading dose of intravenous caffeine administered to preterm infants (< 29 weeks) within the first 2 hours of life compared to 12 hours of life results in improved measures of systemic blood flow (measured by superior vena cava flow)|first 24 hours|||ml/kg/min||Standard Deviation|Mean
664604|NCT01783561|Secondary|Hypotension|To determine if a loading dose of intravenous caffeine administered to preterm infants (< 29 weeks) within the first 2 hours of life compared to 12 hours of life decreases the need for volume replacement or pressors for hypotension within the first 12 hours of life.|first 12 hours of life||||||
664605|NCT01783561|Primary|Intubation|The primary aim of our study is to compare the respiratory effects of caffeine administered in the first 2 hours versus at 12 hours of life in infants <29 weeks' gestation. Our primary hypothesis is that early caffeine administered (at < 2 hours of life) can prevent the need for endotracheal intubation in the first 12 hours of life.|First 12 hours of life|||participants|||Number
664606|NCT01783548|Secondary|Change From Baseline in the Average Morning (AM) and Evening (PM) Subject-Reported Instantaneous Total Nasal Symptom Score (iTNSS) Over The First 6 Weeks Of Treatment In Subjects 4 To 11 Years Of Age|"Instantaneous TNSS is an evaluation of symptom severity over the last 10 minutes prior to the recording of the score. Participants (with assistance from parents/guardians/caregivers, as needed) assessed and recorded four nasal symptoms (runny nose, nasal congestion, nasal itching, and sneezing) twice daily (AM and PM) using the following scale:
0 = absent (no sign/symptom present)
1 = mild (sign/symptom clearly present, but minimal awareness; easily tolerated)
2 = moderate (definite awareness of sign/symptom that is bothersome but tolerable)
3 = severe (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping) The total TNSS scale was 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms.
Baseline and the during study iTNSS values were defined as the average AM and PM subject-reported iTNSS during each time period."|Baseline (Day -4 to Day 1 predose), Days 1 (postdose) to Week 6|Full analysis set (FAS) included all participants in the ITT population who received at least 1 dose of randomized study medication and had at least 1 post-baseline subject-reported rTNSS assessment.||units on a scale||Standard Error|Least Squares Mean
664607|NCT01783548|Secondary|Change From Baseline in the Average Morning (AM) and Evening (PM) Subject-Reported Reflective Total Nasal Symptom Score (rTNSS) Over The First 6 Weeks Of Treatment In Subjects 4 To 11 Years Of Age|"Reflective TNSS is an evaluation of symptom severity over the past 12 hours prior to the recording of the score. Participants (with assistance from parents/guardians/caregivers, as needed) assessed and recorded four nasal symptoms (runny nose, nasal congestion, nasal itching, and sneezing) twice daily (AM and PM) using the following scale:
0 = absent (no sign/symptom present)
1 = mild (sign/symptom clearly present, but minimal awareness; easily tolerated)
2 = moderate (definite awareness of sign/symptom that is bothersome but tolerable)
3 = severe (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping) The total TNSS scale was 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms.
Baseline and the during study rTNSS values were defined as the average AM and PM subject-reported rTNSS during each time period."|Baseline (Day -4 to Day 1 predose), Day 1 (postdose) to Week 6|Full analysis set (FAS) included all participants in the ITT population who received at least 1 dose of randomized study medication and had at least 1 post-baseline subject-reported rTNSS assessment.||units on a scale||Standard Error|Least Squares Mean
664608|NCT01783548|Secondary|Change From Baseline in the Average Morning (AM) and Evening (PM) Subject-Reported Instantaneous Total Nasal Symptom Score (iTNSS) Over The First 6 Weeks Of Treatment In Subjects 6 To 11 Years Of Age|"Instantaneous TNSS is an evaluation of symptom severity over the last 10 minutes prior to the recording of the score. Participants (with assistance from parents/guardians/caregivers, as needed) assessed and recorded four nasal symptoms (runny nose, nasal congestion, nasal itching, and sneezing) twice daily (AM and PM) using the following scale:
0 = absent (no sign/symptom present)
1 = mild (sign/symptom clearly present, but minimal awareness; easily tolerated)
2 = moderate (definite awareness of sign/symptom that is bothersome but tolerable)
3 = severe (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping) The total TNSS scale was 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms.
Baseline and the during study iTNSS values were defined as the average AM and PM subject-reported iTNSS during each time period."|Baseline (Day -4 to Day 1 predose), Days 1 (postdose) to Week 6|Full analysis set (FAS). Subpopulation of study participants aged 6-11 years.||units on a scale||Standard Error|Least Squares Mean
664609|NCT01783548|Primary|Change From Baseline in the Average Morning (AM) and Evening (PM) Subject-Reported Reflective Total Nasal Symptom Score (rTNSS) Over The First 6 Weeks Of Treatment In Subjects 6 To 11 Years Of Age|"Reflective TNSS is an evaluation of symptom severity over the past 12 hours prior to the recording of the score. Participants (with assistance from parents/guardians/caregivers, as needed) assessed and recorded four nasal symptoms (runny nose, nasal congestion, nasal itching, and sneezing) twice daily (AM and PM) using the following scale:
0 = absent (no sign/symptom present)
1 = mild (sign/symptom clearly present, but minimal awareness; easily tolerated)
2 = moderate (definite awareness of sign/symptom that is bothersome but tolerable)
3 = severe (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping) The total TNSS scale was 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms.
Baseline and the during study rTNSS values were defined as the average AM and PM subject-reported rTNSS during each time period."|Baseline (Day -4 to Day 1 predose), Day 1 (postdose) to Week 6|Full analysis set (FAS) included all participants in the ITT population who received at least 1 dose of randomized study medication and had at least 1 post-baseline subject-reported rTNSS assessment. Subpopulation of study participants aged 6-11 years.||units on a scale||Standard Error|Least Squares Mean
664610|NCT01783496|Secondary|Subject Satisfaction With Treatment Results|"subjects were asked to provide satisfaction with treatment results, using the Likert Satisfaction Scale. Scoring was based upon a five point grading System: 5 – Very Satisfied, 4 - Satisfied, 3 – Neither Satisfied nor Dissatisfied, 2 - Dissatisfied, or 1 – Very Dissatisfied.
Data are presented as the proportion of subjects showing improvement as defined as a score of 4 or greater (‘satisfied’ or ‘very satisfied’)."|6 months|||percentage of subjects satisfied|||Number
664611|NCT01783496|Secondary|Improvement in Skin Laxity (Subject Self-assessed)|Improvement in facial and neck laxity 6 months following treatment as self-assessed by subjects using a Quartile Improvement Scale score based upon a five point grading System: 4 - Very Significant Improvement (76-100%), 3 - Marked Improvement (51-75%), 2 - Moderate Improvement (26-50%), 1 - Minor/Mild Improvement (1-25%), or 0 - No Improvement.|6 months|||units on a scale||Standard Deviation|Mean
664612|NCT01783496|Primary|Improvement in Laxity|Improvement in facial and neck laxity 6 months following treatment as assessed by Study Investigator using a Quartile Improvement Scale score based upon a five point grading System: 4 – Very Significant Improvement (76-100%), 3 – Marked Improvement (51-75%), 2 – Moderate Improvement (26-50%), 1 – Minor/Mild Improvement (1-25%), or 0 – No Improvement.|6 months|||units on a scale||Standard Deviation|Mean
664613|NCT01783483|Secondary|Narcotic Usage|Narcotics usage was tabulated and recorded at each follow-up interval and converted to Morphine Equivalence Dose (MED) .|From 3-month to 6 month post-op|Subjects with completed narcotic usage assessment from 3-month to 6-month post op: 100 Suture Wire / 102 SternaLock Blu||milligrams of Morphine Equivalence Dose||Standard Deviation|Mean
664616|NCT01783483|Secondary|Narcotic Usage|Narcotics usage was tabulated and recorded at each follow-up interval and converted to Morphine Equivalence Dose (MED) .|From Hospital Discharge to 3-week post-op|Subjects with completed narcotic usage assessment from hospital discharge to 3-week post op: 109 Suture Wire / 112 SternaLock Blu||milligrams of Morphine Equivalence Dose||Standard Deviation|Mean
664617|NCT01783483|Secondary|Narcotic Usage|Narcotics usage was tabulated and recorded at each follow-up interval and converted to Morphine Equivalence Dose (MED).|Index (Day 0 to Hospital Discharge)|Subjects with completed narcotic usage assessment from Day 0 to hospital discharge: 118 Suture Wire / 114 SternaLock Blu||milligrams of Morphine Equivalence Dose||Standard Deviation|Mean
664618|NCT01783483|Secondary|Pain Measured in a 10-point Scale at 6-month Post Operative|"Intensity of sternal pain assessed using 10 point scale in the following circumstances:
At rest
After forced coughing. Patients score pain 0 to 10 where 0 represents no pain and 10 represents the worst pain a patient can experience"|6-month Post-op|"Pain assessed at resting and after forced coughing. Pain levels of 1 or more were deemed to have pain.
Subjects at 6-month post op with completed pain assessment: 96 Suture Wire / 102 SternaLock Blu"||units on a scale 0-10||Standard Deviation|Mean
664619|NCT01783483|Secondary|Pain Measured in a 10-point Scale at 3-month Post Operative|"Intensity of sternal pain assessed using 10 point scale in the following circumstances:
At rest
After forced coughing. Patients score pain 0 to 10 where 0 represents no pain and 10 represents the worst pain a patient can experience"|3-month Post-op|"Pain assessed at resting and after forced coughing. Pain levels of 1 or more were deemed to have pain.
Subjects at 3-month post op with completed pain assessment 108 Suture Wire / 105 SternaLock Blu"||units on a scale 0-10||Standard Deviation|Mean
664620|NCT01783483|Secondary|Pain Measured in a 10-point Scale at 6-week Post Operative|"Intensity of sternal pain assessed using 10 point scale in the following circumstances:
At rest
After forced coughing. Patients score pain 0 to 10 where 0 represents no pain and 10 represents the worst pain a patient can experience"|6-week Post-op|"Pain assessed at resting and after forced coughing. Only patients who reported pain levels of 1 or more were deemed to have pain.
Subjects at 6-week post op with completed pain assessment: 114 Suture Wire / 112 SternaLock Blu"||units on a scale 0-10||Standard Deviation|Mean
664621|NCT01783483|Secondary|Pain Measured in a 10-point Scale at 3-week Post Operative|"Intensity of sternal pain assessed using 10 point scale in the following circumstances:
At rest
After forced coughing. Patients score pain 0 to 10 where 0 represents no pain and 10 represents the worst pain a patient can experience"|3-week Post-op|"Pain assessed at resting and after forced coughing. Only patients who reported pain levels of 1 or more were deemed to have pain.
Subjects at 3-week post op with completed pain assessment: 107 Suture Wire / 107 SternaLock Blu"||units on a scale 0-10||Standard Deviation|Mean
664622|NCT01783483|Secondary|Pain Measured in a 10-point Scale at Day 7 Post Operative|"Intensity of sternal pain assessed using 10 point scale:
At rest
After forced coughing. Patients score pain 0 to 10 where 0 represents no pain and 10 represents the worst pain a patient can experience"|Day 7|"Pain assessed at resting and after forced coughing. Pain levels of 1 or more were deemed to have pain.
Subjects at 7-Day post op with completed pain assessment: 31 Suture Wire / 30 SternaLock Blu"||units on a scale 0-10||Standard Deviation|Mean
664623|NCT01783483|Primary|Sternal Healing Score at 6 Month Post op, as Defined by a 6-point Scale to Evaluate Bone Healing|"Parameters for scoring:
0 - Nonunion: No contact between sternal halves, absence of gap mineralization, and sclerotic osteotomy margins similar to that of cortical bone. Worst outcome
- Indeterminate: No contact or mineralization between the sternal halves, but osteotomy margins were non-sclerotic, concave, or irregular
- Early healing: Faint mineralization between non-contacting sternal halves, or a thin (1 mm) bridge of bone connecting the sternal halves anteriorly or posteriorly, or near bone-on-bone contact between the sternal halves, with sclerotic osteotomy margins
- Mild synthesis: Bridging bone (i.e., no perceptible gap) along less than 50% of the anteroposterior dimension of the sternal halves, with the sternal halves either offset in the anteroposterior dimension, or aligned in the anteroposterior dimension
- Moderate synthesis: Bridging bone along 50% or more of the anteroposterior dimension of the sternal haves 5- Sternal halves well-aligned. Best outcome"|6-month post-op|Subjects with completed CT scan at 6 months post op: 100 Suture Wire / 101 SternaLock Blu)||units on a scale 0-5||Standard Deviation|Mean
664624|NCT01783483|Primary|Sternal Healing Score at 3 Month Post op, as Defined by a 6-point Scale to Evaluate Bone Healing|"Parameters for scoring:
0 - Nonunion: No contact between sternal halves, absence of gap mineralization, and sclerotic osteotomy margins similar to that of cortical bone. Worst outcome
- Indeterminate: No contact or mineralization between the sternal halves, but osteotomy margins were nonsclerotic, concave, or irregular
- Early healing: Faint mineralization between noncontacting sternal halves, or a thin (1 mm) bridge of bone connecting the sternal halves anteriorly or posteriorly, or near bone-on-bone contact between the sternal halves, with sclerotic osteotomy margins
- Mild synthesis: Bridging bone (i.e., no perceptible gap) along less than 50% of the anteroposterior dimension of the sternal halves, with the sternal halves either offset in the anteroposterior dimension, or aligned in the anteroposterior dimension
- Moderate synthesis: Bridging bone along 50% or more of the antero-posterior dimension of the sternal haves 5- Sternal halves well-aligned. Best outcome"|3-month post-op|Subjects with completed CT scan at 3 month post op: 102 Suture Wire / 103 SternaLock Blu||units on a scale||Standard Deviation|Mean
664625|NCT01783470|Other Pre-specified|Whole-body Energy Expenditure|This is the energy expenditure as calculated using indirect calorimetry.|30 minutes before drug administration followed by 30 minutes after FDG administration||||||
664626|NCT01783470|Primary|BAT Activity as Measured by 18F-FDG PET/CT|difference in BAT metabolic activity measured in placebo and active drug arms. The BAT metabolic activity represents the amount of FDG tracer retained within the tissue. Retained FDG is a biomarker for tissue oxygen consumption and hence energy expenditure by the tissue.|60 min after FDG administration|||mL*SUVmean*g/mL||Inter-Quartile Range|Median
664627|NCT01783418|Primary|Changes in Mood From Baseline to Post-intervention and 6 Months Post-intervention|"PANAS-C - Negative affect
Score range: 0 (minimum score) - 50 (maximum score) Higher scores represent worse outcomes"|Baseline, Post-intervention (8 weeks)|||units on a scale||Standard Deviation|Mean
664628|NCT01783418|Primary|Changes in Mood From Baseline to Post-intervention and 6 Months Post-intervention|"PANAS-C - Positive affect
Score range: 0 (minimum score) - 50 (maximum score)
High scores represent better outcomes"|baseline, Post-intervention (8 weeks)|||units on a scale||Standard Deviation|Mean
666093|NCT01763827|Secondary|Change From Baseline in LDL-C at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||mg/dL||Standard Error|Least Squares Mean
664630|NCT01783418|Secondary|Changes in Mindfulness Propensity and Skills From Baseline to Post-intervention and 6 Months Post-intervention|"Children and Adolescent Mindfulness Measure Score range: 0 (minimum score) - 40 (maximum score)
Higher scores represent better outcomes"|Baseline, Post-intervention (8 weeks)|||units on a scale||Standard Deviation|Mean
664631|NCT01783418|Primary|Changes Sleep From Baseline to Post-intervention and 6 Months Post-intervention|"Pittsburgh Sleep Quality Index
Score range: 0 (minimum score) - 21 (maximum score)
Higher scores indicate worse outcomes"|Baseline, Post-intervention (8 weeks)|||units on a scale||Standard Deviation|Mean
664632|NCT01783418|Primary|Changes in Quality of Life From Baseline to Post-intervention and 6 Months Post-intervention|"Pediatric Cancer Quality of Life Inventory
Scale range: 0 (minimum score) to 108 (maximum score) Higher scores represent better outcomes"|Baseline, Post-intervention (8 weeks)|||units on a scale||Standard Deviation|Mean
664633|NCT01783418|Primary|Changes in Mood From Baseline to Post-intervention and 6 Months Post-intervention|"Beck Youth Inventory - Anxiety scale Subscale range: 0 (minimum score) - 60 (maximum score)
Higher scores indicate higher anxiety and a worse outcome"|Baseline, Post-intervention (8 weeks)|||units on a scale||Standard Deviation|Mean
664634|NCT01783236|Secondary|VAS Score 24 Hours Post-Operation|"24 Hours after the conclusion of the subject's operation, participants were asked to draw a vertical line on the VAS to indicate their level of pain, which was then converted into millimeters for interpretations. Scores ranged from 0-100mm. VAS pain score identifies two extremes on a 10 centimeter horizontal line; the extremes are labeled No Pain (score of 0) and Worst possible pain (score of 100)."|24 hours post-operation|||mm||Inter-Quartile Range|Median
664635|NCT01783236|Secondary|VAS Pain Score 6 Hours Post-Operation|"6 hours after the conclusion of their operation, participants were asked to draw a vertical line on the VAS to indicate their level of pain, which was then converted into millimeters for interpretations. Scores ranged from 0-100mm. VAS pain score identifies two extremes on a 10 centimeter horizontal line; the extremes are labeled No Pain (score of 0) and Worst possible pain (score of 100)."|6 Hours Post-Operation|||mm||Inter-Quartile Range|Median
664636|NCT01783236|Secondary|VAS Pain Score 2 Hours Post Operation|"2 hours after the conclusion of their operation,participants were asked to draw a vertical line on the VAS to indicate their level of pain, which was then converted into millimeters for interpretations. Scores ranged from 0-100mm. VAS pain score identifies two extremes on a 10 centimeter horizontal line; the extremes are labeled No Pain (score of 0) and Worst possible pain (score of 100)."|2 Hours Post Operation|||mm||Inter-Quartile Range|Median
664637|NCT01783236|Secondary|Total Number of PCA Requests in First 24 Hours Post-Operation|The total number of Patient Controlled Analgesic (PCA) requests in the first 24 hours after the conclusion of the subject's operation|24 hours post-operation|||PCA requests||Inter-Quartile Range|Median
664638|NCT01783236|Primary|Total Morphine Consumption (mg)|How much morphine the subject consumes in the first 24 hours after surgery (mg).|24 hours|||mg||Inter-Quartile Range|Median
664639|NCT01783080|Secondary|Social Functioning at Week 12 on the Social Adjustment Scale|Social adjustment was measured using the Social Adjustment Scale (SAS). The SAS is a self-report scale that assesses depressive symptoms and functioning in nine social and work-related domains generating a total score that is indicative of a subject's overall level of social adjustment. Subjects rate their own social functioning over times on a 5-point scale on items covering work for pay, housework, extended family, parenting, marital status, social activity and leisure, family unit and student status (sub-scales). Mean values of all the sub-scales are used, with a range from 0-5. Higher score = worse outcome … worse functioning|Week 12|||unites on a scale||Standard Deviation|Mean
664640|NCT01783080|Secondary|Social Functioning at Week Baseline on the Social Adjustment Scale|Social adjustment was measured using the Social Adjustment Scale (SAS). The SAS is a self-report scale that assesses depressive symptoms and functioning in nine social and work-related domains generating a total score that is indicative of a subject's overall level of social adjustment. Subjects rate their own social functioning over times on a 5-point scale on items covering work for pay, housework, extended family, parenting, marital status, social activity and leisure, family unit and student status (sub-scales). Mean values of all the sub-scales are used, with a range from 0-5. Higher score = worse outcome … worse functioning|baseline|||unites on a scale||Standard Deviation|Mean
664641|NCT01783080|Primary|Paid Work Hours at Week Baseline|Subject-reported paid work hours per week at week baseline|Baseline|||hours||Standard Deviation|Mean
664642|NCT01783080|Primary|Paid Work Hours at Week 12|Subject-reported paid work hours per week at week 12|Week 12|||hours||Standard Deviation|Mean
664643|NCT01783054|Secondary|Number of Adverse Events Reported in Subjects Enrolled.|Assess the safety profile of this neoadjuvant regimen in patients with localized pancreatic adenocarcinoma. All toxicities will be reported by type and grade and tabulated. All adverse events will be reported via case report forms. The intensity of any adverse event should be reported according to the NCI Common Terminology Criteria for Adverse Events v4.0.|First study drug administration until end of study|All subjects who were administered study intervention and had documented adverse events were analyzed. The number below represents the number of adverse events, including serious adverse events, reported on by enrolled subjects. A complete list of the adverse events reported are in the adverse events tables of these results.||adverse events|||Number
664644|NCT01783054|Secondary|Estimate Median Overall Survival|Overall survival is defined as the time from enrollment to death from any cause. Patients still alive at the end of follow up will have their survival time censored at the last date of contact.|2 years|Only subjects who had surgical resection are included in the analysis for this endpoint. At the time of these results, one subject expired due to disease progression. The other subject was still alive at the time of termination, so is not included in the outcome measure data below.||days|||Number
664645|NCT01783054|Secondary|Estimate Median Time to Recurrence.|Time to recurrence is defined as the time from surgical resection to disease recurrence or death from any cause. Patients who have not recurred at the end of follow up will have their recurrence time censored at the last date of contact.|2 years|Only subjects who had surgical resection are included in the analysis for this endpoint. At the time of these results, one subject expired due to disease progression. The other subject was still alive at the time of termination, so is not included in the outcome measure data below.||days|||Number
664985|NCT01777945|Secondary|Clinical Benefit Rate|The percentage of participants with an overall response (complete or partial remission) or with stable disease.|approximately 2 years|||percentage of participants|||Number
664646|NCT01783054|Other Pre-specified|Circulating Tumor Cells (CTC)|To evaluate and describe CTC number, CTC phenotype characteristics and effectiveness/rate of CTC culturing techniquen from patients with pancreatic adenocarcinoma. To determine and evaluate the correlation between expression of biomarkers in CTCs and expression of biomarkers in resected tissue specimen with the same cancer patient.|From enrollment to surgery|This outcome measure was added as part of an amendment. No subjects were enrolled after this amendment was instituted, so no outcomes measures were collected.|||||
664647|NCT01783054|Secondary|Number of Participants With R0 Resection Status.|R0 resection status is a macroscopic complete removal of tumor by non-contaminated operation, with neither macroscopic nor microscopic residual tumor.|at time of surgery|Subjects who had surgical resection are included in the analysis for this endpoint.||participants|||Number
664648|NCT01783054|Primary|Tumor Response|Estimate the rate of good histopathologic tumor response to neoadjuvant chemotherapy assessed in resection specimen. A good response is defined as a grade III or IV histopathologic appearance, equivalent to <10% viable tumor.|at time of surgery|The study terminated early and the data for this outcome measure was not documented.|||||
664649|NCT01783015|Secondary|Number of Participants With Positive Etanercept Neutralizing Anti-drug Antibody Status|Blood samples (6 mL) were collected at the baseline, Week 12, and Week 24 visits, or upon early withdrawal, to provide a minimum of 1 mL serum each for ETN ADA and ETN neutralizing antibody analyses. Samples which were positive for ETN anti-drug antibodies were then also tested for ETN neutralizing antibodies.|Baseline, 12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.|||||
664650|NCT01783015|Secondary|Number of Participants With Positive Etanercept Anti-drug Antibody Status|Blood samples (6 mL) were collected at the baseline, Week 12, and Week 24 visits, or upon early withdrawal, to provide a minimum of 1 mL serum each for ETN ADA and ETN neutralizing antibody analyses. Samples which were positive for ETN anti-drug antibodies were then also tested for ETN neutralizing antibodies.|Baseline, 12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.|||||
664651|NCT01783015|Secondary|Change From Baseline in Vectra Disease Activity Levels|The change from Baseline in Vectra disease activity levels was to be estimated. The assessment measures serum protein biomarkers associated with RA. It has a range from 1-100 with lower scores indicating the better outcome.|Baseline, 12 weeks, 24 weeks|Vectra disease activity analysis of laboratory samples was not conducted due to study termination.|||||
664652|NCT01783015|Secondary|Change From Baseline in Patient Acceptable Symptom State (PASS)|The Patient Acceptable Symptom State (PASS) was a participant-completed form in which participants were asked to “Think about all the ways your rheumatoid arthritis (RA) has affected you during the last 48 hours. If you were to remain in the next few months as you were during the last 48 hours, would this be acceptable or unacceptable to you?” The participant indicated a response of either “acceptable” or “unacceptable”.|Baseline, 12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.|||||
664653|NCT01783015|Secondary|Change From Baseline in Short Form-36 Health Survey (SF-36)|The 36-Item Short Form Health Survey (SF-36) is widely used 36-item questionnaire that measures general health-related quality of life in the following 8 domains: physical function, role limitations due to physical health, bodily pain, general health perception, vitality, social functioning, role limitation due to emotional problems, and mental health. Scores for the 8 domains range from 0 to 100 where higher scores are better.|Baseline, 12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.|||||
664654|NCT01783015|Secondary|Change From Baseline in Euro Quality of Life (Qol) EQ-5 Dimensions Questionnaire (EQ-5D)|The EuroQol-5 Dimensions (EQ-5D) is a participant-completed questionnaire designed to assess health related quality of life. There are 2 components to the EQ-5D: a Health State Profile and a VAS. For the Health State Profile, participants recorded their level of current health for 5 domains comprising a health profile: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Scores from the 5 domains may be used to calculate a single index value, also known as a utility score. On the VAS participants were asked to rate their current health on a scale from 0 to 100 mm, where 0 represented the “worst imaginable health state” and 100 represented the “best imaginable health state.” In addition to a summary of mean changes, 1 categorical endpoint each based on EQ-5D utility score and 1 based on the VAS were derived and analyzed: EQ-5D utility score improvement ≥0.05 and EQ-5D VAS score >82.|Baseline, 12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.|||||
664655|NCT01783015|Secondary|Change From Baseline in Health Assessment Questionnaire Disability and Discomfort Scales (HAQ-DI)|Health Assessment Questionnaire-Disability Index (HAQ-DI): participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, 12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.|||||
664656|NCT01783015|Secondary|Change From Baseline in CRP|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, 12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.|||||
664657|NCT01783015|Secondary|Change From Baseline in Subject Pain|Subject Pain was to be measured on a 0 to 100 mm Visual Analog Scale (VAS), with 0 mm = no pain and 100 mm = most severe pain.|Baseline, 12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.|||||
664658|NCT01783015|Secondary|Change From Baseline in Subject General Health VAS.|Subject General Health VAS assessment (participant rated health assessment with scores ranging 0 to 100; higher scores indicate worse health status).|Baseline, 12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.|||||
664659|NCT01783015|Secondary|Change From Baseline in Subject Global Assessment of Disease Activity|Change from Baseline in Subject Global Assessment of Disease Activity was to be estimated. Participants were to assess their overall disease activity over the last 2 to 3 days using a scale between 0 (no disease activity) and 10 (extreme disease activity).|Baseline, 12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.|||||
664660|NCT01783015|Secondary|Change From Baseline in Physician Global Assessment of Disease Activity|Change from Baseline in the PGA scores was to be estimated. The Study Physician estimated the participant's overall disease activity over the last 2 to 3 days using a scale between 0 (no disease activity) and 10 (extreme disease activity).|Baseline, 12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.|||||
664661|NCT01783015|Secondary|Change From Baseline in Number of Swollen Joints|Change from Baseline in the number of swollen joints including shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints, and knees was to be calculated.|Baseline, 12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.|||||
664662|NCT01783015|Secondary|Change From Baseline in Number of Tender/Painful Joints|Change from Baseline in the number of tender/painful joints using the 28 joint count including shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints, and knees was to be calculated.|Baseline, 12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.|||||
664663|NCT01783015|Secondary|Change From Baseline in SDAI.|Change from Baseline in SDAI scores were to be calculated. The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, SGA and PGA assessed on 0-10 point scale; higher scores=greater affliction due to disease activity, and CRP (mg/dL). SDAI total score= 0-86. SDAI <=3.3 indicates disease remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity.|Baseline, 12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.|||||
664664|NCT01783015|Secondary|Change From Baseline in CDAI|Change from Baseline in CDAI scores was to be calculated. The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, SGA and PGA assessed on 0-10 point scale; higher scores=greater affliction due to disease activity. CDAI total score = 0-76. CDAI <= 2.8 indicates disease remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high disease activity.|Baseline, 12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.|||||
664665|NCT01783015|Secondary|Number of Participants Achieving Low Disease Activity or Remission Based on Simplified Disease Activity Index (SDAI).|The SDAI is the numerical sum of five outcome parameters: TJC) and SJC based on a 28-joint assessment, SGA and PGA assessed on 0-10 point scale; higher scores=greater affliction due to disease activity, and CRP (mg/dL). SDAI total score= 0-86. SDAI <=3.3 indicates disease remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity.|12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.|||||
664666|NCT01783015|Secondary|Number of Participants Achieving Low Disease Activity or Remission Based on Clinical Disease Activity Index (CDAI)|The CDAI is the numerical sum of 4 outcome parameters: tender joint count (TJC) and SJC based on a 28-joint assessment, SGA and PGA assessed on 0-10 point scale; higher scores=greater affliction due to disease activity. CDAI total score = 0-76. CDAI <= 2.8 indicates disease remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high disease activity.|12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.|||||
664667|NCT01783015|Secondary|Number of Participants Achieving European League Against Rheumatism (EULAR) Good and/or Moderate Response.|The Disease Activity Score Based on 28-joints Count based (DAS28-based) EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to =<5.1 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1.|12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.|||||
664668|NCT01783015|Secondary|Number of Participants Achieving American College of Rheumatology 90% (ACR90) Response|ACR90 response: greater than or equal to (≥) 90 percent (%) improvement in tender or swollen joint counts and ≥ 90% improvement in 3 of the 5 remaining ACR core measures: participant's assessment of pain; SGA of disease activity; PGA of disease activity; subject's assessment of functional disability via a HAQ; and CRP.|12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.|||||
664669|NCT01783015|Secondary|Number of Participants Achieving American College of Rheumatology 70% (ACR70) Response|ACR70 response: greater than or equal to (≥) 70 percent (%) improvement in tender or swollen joint counts and ≥ 70% improvement in 3 of the 5 remaining ACR core measures: participant's assessment of pain; SGA of disease activity; PGA of disease activity; subject's assessment of functional disability via a HAQ; and CRP.|12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.|||||
664670|NCT01783015|Secondary|Number of Participants Achieving American College of Rheumatology 50% (ACR50) Response|ACR50 response: greater than or equal to (≥) 50 percent (%) improvement in tender or swollen joint counts and ≥ 50% improvement in 3 of the 5 remaining ACR core measures: participant's assessment of pain; SGA of disease activity; PGA of disease activity; subject's assessment of functional disability via a HAQ; and CRP.|12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.|||||
664671|NCT01783015|Secondary|Number of Participants Achieving American College of Rheumatology 20% (ACR20) Response|ACR20 response: greater than or equal to (≥) 20 percent (%) improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: participant's assessment of pain; Subject Global Assessment (SGA) of disease activity; Physician Global Assessment (PGA) of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and CRP.|12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.|||||
664672|NCT01783015|Secondary|Number of Participants With DAS28 <2.6|Number of Participants with DAS28 <2.6. A DAS28 < 2.6 implies remission.|12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.|||||
664673|NCT01783015|Secondary|Number of Participants With DAS28 <3.2|Number of participants with DAS28 <3.2. A score of < 3.2 implied low disease activity.|12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.|||||
664674|NCT01783015|Secondary|Change From Baseline in the DAS28 at Week 24|DAS28 calculated from the number of SJC and PJC using the 28 joints count, the CRP and and Subject General Health VAS assessment (participant rated health assessment with scores ranging 0 to 100; higher scores indicate worse health status).|Baseline, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.|||||
664675|NCT01783015|Primary|Change From Baseline in the Disease Activity Score Based on a 28 Joint Count (DAS28-C-reactive Protein [CRP]) at Week 12.|DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the c-reactive protein (CRP) and Subject General Health Visual Analogue Scale (VAS) assessment (participant rated health assessment with scores ranging 0 to 100; higher scores indicate worse health status).|Baseline, 12 weeks|Due to small sample size, Pfizer did not perform statistical analysis.|||||
664676|NCT01782898|Secondary|Post Operative Pain Reported by the Subject.|Post operative pain reported by the subject as determined as area under the numeric rating scale for pain versus time curve in the post anesthesia care unit ( score*min).Numeric rating scale for pain on a scale of 0-10 (0 is no pain and 10 is high pain) versus time curve in the post anesthesia care unit ( score * min). A higher value indicates more pain over 24 hours.The range is 0 pain to x time in minutes x hour ( 60-1440 minutes) . The pain scores were collected at 15 minute intervals from the time of admission to the PACU to 24 hours after the surgical procedure. The area under the NRS pain scale versus time curve was calculated using the trapezoidal method as an indicator of pain burden during early recovery (Graph Pad Prism ver 5.03, Graph Pad Software INC.|24 hour|||(pain score * minutes ) in the PAC U||Inter-Quartile Range|Median
664677|NCT01782898|Secondary|Postoperative Opioid Consumption|The total amount of opioid consumed by subject at 24 hours after surgery measured in IV morphine equivalents.|24 hours|||IV mg of morpine equivalents||Inter-Quartile Range|Median
664678|NCT01782898|Primary|Qor-40 at 24 Hours Postoperative|"Quality of recovery questionnaire score at 24 hours after surgery. Quality of recovery score 24 hours after the surgical procedure.Score of 40 is poor recovery and a score of 200 is good recovery.
Time frame for this evaluation is 24 hours after the surgical procedure"|24 hours|||units on a scale 40 low-200 high||Inter-Quartile Range|Median
664679|NCT01782885|Other Pre-specified|Change in SF-12v2 Health Survey|The Spanish (Mexico) version of the SF-12v2 Health Survey uses 12 questions to measure functional health and well-being from the patient’s point of view. All 12 items from the survey can be summarized in two main domains (physical and mental health). Physical and Mental Health Composite Scores (PCS and MCS) are computed using the scores of 12 questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.|24 weeks|||units on a scale||Standard Deviation|Mean
664680|NCT01782885|Other Pre-specified|Change in SF-12v2 Health Survey|The Spanish (Mexico) version of the SF-12v2 Health Survey uses 12 questions to measure functional health and well-being from the patient’s point of view. All 12 items from the survey can be summarized in two main domains (physical and mental health). Physical and Mental Health Composite Scores (PCS and MCS) are computed using the scores of 12 questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.|12 weeks|||units on a scale||Standard Deviation|Mean
664681|NCT01782885|Other Pre-specified|Change in SF-12v2 Health Survey|The Spanish (Mexico) version of the SF-12v2 Health Survey uses 12 questions to measure functional health and well-being from the patient’s point of view. All 12 items from the survey can be summarized in two main domains (physical and mental health). Physical and Mental Health Composite Scores (PCS and MCS) are computed using the scores of 12 questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.|6 weeks|||units on a scale||Standard Deviation|Mean
664682|NCT01782885|Primary|Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)|The WOMAC evaluation will be performed on patients who received the treatment at 0, 6, 12, 24 weeks after treatment is finished. The WOMAC measures five items for pain (score range 0–20), two for stiffness (score range 0–8), and 17 for functional limitation (score range 0–68). A total WOMAC score is created by summing the items for all three subscales (score range 0-96). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.|24 weeks|||units on a scale||Standard Deviation|Mean
664683|NCT01782885|Primary|Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)|The WOMAC evaluation will be performed on patients who received the treatment at 0, 6, 12, 24 weeks after treatment is finished. The WOMAC measures five items for pain (score range 0–20), two for stiffness (score range 0–8), and 17 for functional limitation (score range 0–68). A total WOMAC score is created by summing the items for all three subscales (score range 0-96). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.|12 weeks|||units on a scale||Standard Deviation|Mean
664684|NCT01782885|Primary|Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)|The WOMAC evaluation will be performed on patients who received the treatment at 0, 6, 12, 24 weeks after treatment is finished. The WOMAC measures five items for pain (score range 0–20), two for stiffness (score range 0–8), and 17 for functional limitation (score range 0–68). A total WOMAC score is created by summing the items for all three subscales (score range 0-96). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.|6 weeks|||units on a scale||Standard Deviation|Mean
664685|NCT01782885|Primary|Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)|The WOMAC evaluation will be performed on patients who received the treatment at 0, 6, 12, 24 weeks after treatment is finished. The WOMAC measures five items for pain (score range 0–20), two for stiffness (score range 0–8), and 17 for functional limitation (score range 0–68). A total WOMAC score is created by summing the items for all three subscales (score range 0-96). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.|0 weeks|||units on a scale||Standard Deviation|Mean
664686|NCT01782885|Other Pre-specified|Change in SF-12v2 Health Survey|The Spanish (Mexico) version of the SF-12v2 Health Survey uses 12 questions to measure functional health and well-being from the patient’s point of view. All 12 items from the survey can be summarized in two main domains (physical and mental health). Physical and Mental Health Composite Scores (PCS and MCS) are computed using the scores of 12 questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.|0 weeks|||units on a scale||Standard Deviation|Mean
664687|NCT01782885|Secondary|Change in Visual Analog Scale (VAS)|The visual analog scale (VAS) is a psychometric response scale which measures subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their current level of pain by indicating a position along a continuous line of 10 cm. Subject is asked: on a scale of 0 to 10, with 0 being no pain and 10 being the worst pain imaginable, what you rate your current pain?|0-24 weeks|||Centimeters||Standard Deviation|Mean
664690|NCT01782872|Secondary|Duration of Analgesia From Interscalene Nerve Block|Median time until a patient needed to take opioid pain medication|Postoperative day 1 at 8AM & 5PM, postoperative day 2 at 8AM & 5PM|Patients who were able to provide actual or estimates of time until they first needed to use pain medication were included in this analysis.||hours||Standard Error|Mean
664691|NCT01782872|Primary|Numeric Rating Scale (NRS) Pain Score With Movement|Pain with movement at 24 hours from the nerve block (scale of 0-10; 0 = no pain, 10 = worst possible pain)|24 hours after the interscalene block is given|||units on a scale||Standard Deviation|Mean
664692|NCT01782859|Secondary|Pain at 3 Months Post-op|At 3 months postoperatively, patients were asked to rate their pain on a scale of 0-10, with 0 being no pain and 10 being worst pain.|3 months postoperatively|||units on a scale||Standard Deviation|Mean
664693|NCT01782859|Secondary|Desmosine Level (Marker of Lung Injury)|The time frame of the study for each patient covers the period between time of surgery and until discharge from the hospital.|Participants will be followed from the time of surgery until discharge, expected average of 3-5 days|Desmosine levels were not analyzed.|||||
664694|NCT01782859|Secondary|Interleukin (IL)-6 Cytokine Release (Inflammatory Marker)|The time frame of the study for each patient covers the period between time of surgery and until discharge from the hospital.|Participants will be followed from the time of surgery until discharge, expected average of 3-5 days|||picograms/milliliter||Standard Deviation|Mean
664695|NCT01782859|Primary|Plasmin-a 2 Antiplasmin Complex (PAP)||First 24 hours after surgery|||mcg/L||Standard Deviation|Mean
664696|NCT01782859|Primary|Serum Prothrombin Fragment 1 and 2 (PF 1.2)||First 24 hours after surgery|||pmol/mL||Standard Deviation|Mean
664697|NCT01782742|Secondary|Change in the Ratio of Beta Amyloid 42 to Beta Amyloid 40 in Non ApoE4 Carriers|This measures the change in the ratio of Beta Amyloid 42 to Beta Amyloid 40 from baseline to week 4 in non ApoE4 Carriers|Baseline to Week 4|Of the 7 total subjects who were non-ApoE carriers, only 6 subjects were able to provide adequate blood sample for this serum biomarker analysis. Attempts for blood sample procurement for the other 1 subject were unsuccessful.||ratio||95% Confidence Interval|Mean
664698|NCT01782742|Secondary|Change in the Ratio of Beta Amyloid 42 to Beta Amyloid 40 in All Subjects|This measures the change in the ratio of Beta Amyloid 42 to Beta Amyloid 40 from baseline to week 4 in all subjects|Baseline to Week 4|There were only a total of 17 subjects who were able to provide adequate blood sample for this serum biomarker analysis. Attempts for blood sample procurement for the other 3 subjects were unsuccessful.||ratio||95% Confidence Interval|Mean
664699|NCT01782742|Secondary|Serum Biomarker Outcome Level Changes From Baseline to Week 4 in Beta amyloid1-40 and Beta amyloid1-42 (Non ApoE4 Carriers)|Change from baseline to week 4 in beta amyloid1-40 and beta amyloid1-42 serum levels comprised in secondary biomarker outcomes (non ApoE4 carriers)|Baseline to Week 4|Change from baseline to week 4 in beta amyloid1-40 and beta amyloid1-42 serum levels in non ApoE4 carriers. Of the 7 total subjects who were non-ApoE carriers, only 6 subjects were able to provide adequate blood sample for this serum biomarker analysis. Attempts for blood sample procurement for the other 1 subject were unsuccessful.||pmol/L||95% Confidence Interval|Mean
664700|NCT01782742|Secondary|Secondary Outcome Measuring Serum Biomarker Outcome Level Changes From Baseline to Week 4 in Beta amyloid1-40 and Beta amyloid1-42 (ALL SUBJECTS)|Change from baseline to week 4 in beta amyloid1-40 and beta amyloid1-42 serum levels comprised in secondary biomarker outcomes|Baseline to Week 4|Change from baseline to week 4 in beta amyloid1-40 and beta amyloid1-42 serum levels comprised in secondary biomarker outcomes in ALL SUBJECTS. There were only a total of 17 subjects who were able to provide adequate blood sample for this serum biomarker analysis. Attempts for blood sample procurement for the other 3 subjects were unsuccessful.||pmol/L||95% Confidence Interval|Mean
664701|NCT01782742|Primary|Primary Outcome by Genotype (HOMOZYGOTE ApoE4 CARRIERS)|"This measures the change from baseline on treatment compared to placebo at week 4 on composite and regional beta amyloid burden according to ApoE genotype (HOMOZYGOTE ApoE4 CARRIERS)
There are no homozygote ApoE4 carriers on the placebo arm, therefore no data can be presented on this arm."|Baseline to Week 4|"Change in composite and regional Beta Amyloid burden on Homozygote ApoE4 carriers.
There are no homozygote ApoE4 carriers on the placebo arm, therefore no data can be presented on this arm."||SUVr||95% Confidence Interval|Mean
664702|NCT01782742|Primary|Primary Outcome by Genotype (HETEROZYGOTE ApoE4 CARRIERS)|This measures the change from baseline on treatment compared to placebo at week 4 on composite and regional beta amyloid burden according to ApoE genotype (HETEROZYGOTE ApoE4 CARRIERS)|Baseline to Week 4|Change in composite and regional Beta Amyloid burden on Heterozygote ApoE4 carriers||SUVr||95% Confidence Interval|Mean
664703|NCT01782742|Primary|Primary Outcome by Genotype (ApoE4 CARRIERS)|This measures the change from baseline on treatment compared to placebo at week 4 on composite and regional beta amyloid burden according to ApoE genotype (E-4 carriers)|Baseline to Week 4|Change in composite and regional Beta Amyloid burden on ApoE4 carriers||SUVr||95% Confidence Interval|Mean
664704|NCT01782742|Primary|Primary Outcome by Genotype (NON ApoE4 CARRIERS)|Measures changes from baseline on treatment compared to placebo at week 4 on composite and regional Beta Amyloid burden according to ApoE genotype (NON ApoE4 CARRIERS)|Baseline to Week 4|Change in composite and regional Beta Amyloid Burden on non-ApoE4 carriers||SUVr||95% Confidence Interval|Mean
664705|NCT01782742|Primary|Primary Outcome by Genotype (ALL SUBJECTS)|This measures the change from baseline on treatment compared to placebo at week 4 on composite and regional beta amyloid burden according to ApoE genotype (E-4 carriers compared to E-4 non-carriers)|Baseline to Week 4|Change om composite and regional Beta Amyloid burden according to ApoE genotype on ALL SUBJECTS||SUVr||95% Confidence Interval|Mean
664706|NCT01782742|Secondary|Change in the Activities of Daily Living (ADCS-ADL) Score in ALL Subjects From Baseline to Week 4|The ADCS-ADL is an activities-of-daily-living inventory developed by the ADCS to assess functional performance in participants with AD (Galasko et al., 1997). Using a structured interview format, study partners are queried as to whether participants attempted each item in the inventory during the prior 4 weeks and their level of performance. Overall score range from 0 meaning fully independent to 78 meaning fully dependent on assistance for activities of daily living|Baseline to Week 4|||points||95% Confidence Interval|Mean
664789|NCT01781481|Primary|Number of Visits to the Hospital Emergency Department|Number of times that the patient visited the hospital Emergency Department in the 3-month period prior to the Pediatric INTERMED interview.|Data collected through chart review with respect to the three month period prior to Day 1 (date of patient's participation in Pediatric Intermed interview)|||Emergency Department Visits||Full Range|Median
664707|NCT01782742|Secondary|Change in NPI Scores in ALL Subjects From Baseline to Week 4|The NPI is a well validated, reliable, multi-item instrument to assess psychopathology in AD based on interview with the study partner. The NPI evaluates both the frequency and severity of 10 neuropsychiatric disturbances. Frequency assessments range from 1 (occasionally, less than once per week) to 4 (very frequently, once or more per day or continuously) as well as severity (1=mild, 2=moderate, 3=severe). The overall score and the score for each subscale are the product of severity and frequency. Overall score range from 0 meaning no disturbance to 144 meaning severe disturbance|Baseline to Week 4|||points||95% Confidence Interval|Mean
664708|NCT01782742|Secondary|Change in the Global Clinical Dementia Rating Score in ALL Subjects From Baseline to Week 4|The CDR is a clinical scale that rates the severity of dementia as absent, questionable, mild, moderate, or severe (CDR score of 0, 0.5, 1, 2, or 3, respectively). Higher score means more severe dementia rating. The score is based on interviews with the participant and study partner, using a structured interview that assesses six domains: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care.|Baseline to Week 4|||units on a scale||95% Confidence Interval|Mean
664709|NCT01782742|Secondary|Change in ADAS-Cog Score in ALL Subjects From Baseline to Week 4|The ADAS-Cog is a psychometric instrument that evaluates memory, attention, reasoning, language, orientation, and praxis. A higher score indicates more impairment. Scores from the original portion of the test range from 0 (best) to 85 (worse). A positive change indicates cognitive worsening.|Baseline to Week 4|||points||95% Confidence Interval|Mean
664710|NCT01782742|Secondary|Change in MMSE Score in ALL Subjects From Baseline to Week 4|The MMSE evaluates orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two overlapping pentagons. A lower score indicates more cognitive impairment. The lowest score that any particular person can get is 0 and the highest score is 30.|Baseline to Week 4|||points||95% Confidence Interval|Mean
664711|NCT01782742|Primary|Drug-Placebo Difference in Change From Baseline to Week 4 in the Composite Amyloid Burden of the Brain|The primary study endpoint for all subjects is the change from baseline to Week 4 in amyloid burden as measured by standard uptake units regional (SUVr) on amyloid brain imaging obtained through 18F-AV-45 PET|Baseline to Week 4|||SUVr||95% Confidence Interval|Mean
664712|NCT01782664|Secondary|Change From Baseline in Serum Neopterin Concentrations at Weeks 2, 4, 8 and 12|Serum Neopterin is a marker of psoriatic disease activity. Blood samples were collected for estimation of serum neoprotein concentration. Baseline was Day 1. The change from Baseline was the difference between post-Baseline and Baseline.|Baseline (pre-dose) and Weeks 2, 4, 8 and 12|ITT Population||Nanomol per Liter (nmol/L)||Standard Deviation|Mean
664713|NCT01782664|Secondary|Steady State Volume of Distribution (Vss) of GSK2586184|Blood samples were taken to measure plasma concentrations of GSK2586184. A two-compartment model with a three-compartment transit model was used to derive PK parameters.|Baseline (pre-dose), Day 14 (2 to 3 hour and 3 to 4 hour post-dose), Day 28 (4 to 6 hour and 6 to 8 hour post-dose), Day 56 (at anytime during clinical visit), Day 84 (1 sample to be taken at anytime during clinical visit)|PK Population||L||Geometric Coefficient of Variation|Geometric Mean
664714|NCT01782664|Secondary|Clearance of GSK2586184|Blood samples were taken to measure plasma concentrations of GSK2586184. A two-compartment model with a three-compartment transit model was used to derive PK parameters.|Baseline (pre-dose), Day 14 (2 to 3 hour and 3 to 4 hour post-dose), Day 28 (4 to 6 hour and 6 to 8 hour post-dose), Day 56 (at anytime during clinical visit), Day 84 (1 sample to be taken at anytime during clinical visit)|PK Population.||Litre (L)/hr||Geometric Coefficient of Variation|Geometric Mean
664715|NCT01782664|Secondary|Population Pharmacokinetic (PK) Derived Area Under the Concentration-time Curve From Time Zero (Pre-dose) to the Time of the Last Measureable Concentration (AUC(0-tau) of GSK2586184|Blood samples were taken to measure plasma concentrations of GSK2586184. A two-compartment model with a three-compartment transit model was used to derive PK parameters.|Baseline (pre-dose), Day 14 (2 to 3 hour and 3 to 4 hour post-dose), Day 28 (4 to 6 hour and 6 to 8 hour post-dose), Day 56 (at anytime during clinical visit), Day 84 (1 sample to be taken at anytime during clinical visit)|PK population. The PK Population comprised of all participants who were randomized and received at least one dose of study medication.||Nanogram/milliLitre*hour (ng/mL*hr)||Geometric Coefficient of Variation|Geometric Mean
664716|NCT01782664|Secondary|Change From Baseline of Dermatology Life Quality Index (DLQI) Score at Week 12|The DLQI was used to assess a participant’s health-related quality of life. Participants completed the questionnaire to evaluate how their psoriasis affected their life over the week before the assessment took place. Each of the 10 questions was scored out of 0–3 as; 0 = Not at all, 1 = A little, 2 = A lot and 3 = Very much. The total score for the DLQI was calculated by adding up all the individual scores for each question resulting in a minimum of 0 and a maximum of 30. Higher score indicated worsening of participant’s quality of life. The Baseline value was the value obtained on Day 1. The change from Baseline was the difference between post-Baseline and Baseline.|Baseline and Week 12|ITT Population. Only those participants who had a Week 12 evaluation were analyzed.||Scores on a Scale||Standard Deviation|Mean
664717|NCT01782664|Secondary|Itch VAS Scores at Week 2, 4, 8 and 12|The visual analogue scale (VAS) was used to assess itch. The participants rated the intensity of itch over the past week by marking a line on a 100 mm (0 to 100 mm) long scale. A line placed on the extreme left, that is 0 mm indicated no noticeable itching sensation and extreme right that is 100 mm indicated maximum itching sensation. This scale has no subscales. The participant perception of their symptoms was measured using the VAS itch score. Itch VAS scores at Week 2, 4, 8 and 12 are reported.|Week 2, 4, 8 and 12|ITT Population. Only those participants available at the specified time points were analyzed.||Scores on a Scale||Standard Deviation|Mean
664718|NCT01782664|Secondary|Change From Baseline in the Itch Visual Analogue Scale (VAS) Score at Week 2, 4, 8 and 12|The visual analogue scale (VAS) was used to assess itch. The participants rated the intensity of itch over the past week by marking a line on a 100 millimeter(mm) (0 to 100 mm) long scale. A line placed on the extreme left, that is 0 mm indicated no noticeable itching sensation and extreme right that is 100 mm indicated maximum itching sensation. This scale has no subscales. The participant perception of their symptoms was measured using the VAS itch score. The Baseline value was the value obtained on Day 1. The change from Baseline was the difference between post-Baseline and Baseline.|From Baseline (Day 1) until Week 12|ITT Population. Only those participants available at the specified time points were analyzed.||Scores on a Scale||Standard Deviation|Mean
664719|NCT01782664|Secondary|Time to PGA Score of 'Clear' (0) or 'Almost Clear' (1)|The severity of psoriatic lesions over the whole body were assessed by the investigator using the PGA scoring system. A 0 to 6 point rating scale was used, as follows: 0 = Clear (no signs of psoriasis), 1 = Almost clear (slight elevation, scale and/or erythema), 2 = Mild (mild plaque elevation, scale and/or erythema), 3 = Mild to moderate (mild plaque elevation with moderate erythema and/or scale)4 = Moderate (moderate plaque elevation, scale and/or erythema), 5 = Moderate to severe (marked plaque elevation, scale and/or erythema), 6 = Severe (very marked plaque elevation, scale and/or erythema). The Baseline value was the value obtained on Day 1. The scores were reported with the last observation carried forward (LOCF) analysis.|From Baseline (Day 1) until Week 12|ITT Population. Only participants achieving a PGA score of 'Clear' or 'Almost Clear' were analyzed.||Days||Full Range|Median
664720|NCT01782664|Secondary|Time to PASI 75|PASI 75 was >= 75% improvement from Baseline in PASI score. Psoriatic lesions were assessed by the investigator using a PASI score. PASI score was determined by evaluation of BSA covered by plaque psoriasis in 4 areas (head/neck, arms, trunk and legs with area score of 0.1, 0.2, 0.3 and 0.4 respectively). This test included combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale such that 0=0% involvement, 1=1-9%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89% and 6=90-100%) and severity (evaluated individually using a 5-point scale that ranged as 0=No evidence of sign, 1=slight evidence, 2=moderate evidence, 3=marked evidence and 4=very marked, most severe evidence of sign) of erythema, induration and desquamation in each of the same 4 areas. PASI score ranges from 0(no psoriasis) to 72(worse psoriasis). Final PASI=(sum of severity score for each area)x(% body affected score x area score). Baseline was Day 1.|From Baseline (Day 1) until Week 12|ITT Population. Only participants achieving PASI 75 were analyzed.||Days||Full Range|Median
664721|NCT01782664|Secondary|Percentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12|The severity of psoriatic lesions over the whole body were assessed by the investigator using the PGA scoring system. A 0 to 6 point rating scale was used, as follows: 0 = Clear (no signs of psoriasis), 1 = Almost clear (slight elevation, scale and/or erythema), 2 = Mild (mild plaque elevation, scale and/or erythema), 3 = Mild to moderate (mild plaque elevation with moderate erythema and/or scale), 4 = Moderate (moderate plaque elevation, scale and/or erythema), 5 = Moderate to severe (marked plaque elevation, scale and/or erythema), 6 = Severe (very marked plaque elevation, scale and/or erythema). Higher scores indicated worse psoriasis. The Baseline value was the value obtained on Day 1. The scores were reported with the last observation carried forward (LOCF) analysis.|Weeks 2, 4, 8 and 12|ITT Population. Only those participants available at the specified time points were analyzed.||Percentage of Participants|||Number
664722|NCT01782664|Secondary|Percentage of Participants Who Had a Physician Global Assessment (PGA) Score of ‘Clear’ (0) or ‘Almost Clear’ (1) at Weeks 2, 4, 8 and 12|The severity of psoriatic lesions over the whole body were assessed by the investigator using the PGA scoring system. A 0 to 6 point rating scale was used, as follows: 0 = Clear (no signs of psoriasis), 1 = Almost clear (slight elevation, scale and/or erythema), 2 = Mild (mild plaque elevation, scale and/or erythema), 3 = Mild to moderate (mild plaque elevation with moderate erythema and/or scale), 4 = Moderate (moderate plaque elevation, scale and/or erythema), 5 = Moderate to severe (marked plaque elevation, scale and/or erythema), 6 = Severe (very marked plaque elevation, scale and/or erythema). Higher scores indicated worse psoriasis. The Baseline value was the value obtained on Day 1. The scores were reported with the last observation carried forward (LOCF) analysis.|Weeks 2, 4, 8 and 12|ITT Population||Percentage of Participants|||Number
664723|NCT01782664|Secondary|Percentage of Participants Who Had a PASI Score With 50%, 75% and 90% Improvement From Baseline Until Week 12|Psoriatic lesions were assessed using the PASI. PASI score was determined by evaluation of BSA covered by plaque psoriasis in 4 areas (head/neck, arms, trunk and legs with area score of 0.1, 0.2, 0.3 and 0.4 respectively). This test included combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale such that 0=0% involvement, 1=1-9%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89% and 6=90-100%) and severity (evaluated individually using a 5-point scale that ranged as 0=No evidence of sign, 1=slight evidence, 2=moderate evidence, 3=marked evidence and 4=very marked, most severe evidence of sign) of erythema, induration and desquamation in each of the same 4 areas. PASI score ranges from 0(no psoriasis) to 72(worse psoriasis). Final PASI=(sum of severity score for each area)x(% body affected score x area score). Baseline was Day 1.|From Baseline (Day 1) until Week 12|ITT Population.||Percentage of Participants|||Number
664724|NCT01782664|Secondary|PASI Score at Week 2, 4, 8 and 12|Psoriatic lesions were assessed using the PASI. PASI score was determined by evaluation of BSA covered by plaque psoriasis in 4 areas (head/neck, arms, trunk and legs with area score of 0.1, 0.2, 0.3 and 0.4 respectively). This test included combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale such that 0=0% involvement, 1=1-9%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89% and 6=90-100%) and severity (evaluated individually using a 5-point scale that ranged as 0=No evidence of sign, 1=slight evidence, 2=moderate evidence, 3=marked evidence and 4=very marked, most severe evidence of sign) of erythema, induration and desquamation in each of the same 4 areas. PASI score ranges from 0(no psoriasis) to 72(worse psoriasis). Final PASI=(sum of severity score for each area)x(% body affected score x area score). Baseline=Day 1.|Week 2, 4, 8 and 12|ITT Population. Only those participants available at the specified time points were analyzed.||Scores on a Scale||Standard Deviation|Mean
664725|NCT01782664|Secondary|Change From Baseline (BL) in the PASI Score at Week 2, 4, 8 and 12|Psoriatic lesions were assessed using the PASI. PASI score was determined by evaluation of BSA covered by plaque psoriasis in 4 areas (head/neck, arms, trunk and legs with area score of 0.1, 0.2, 0.3 and 0.4 respectively). This test included combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale such that 0=0% involvement, 1=1-9%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89% and 6=90-100%) and severity (evaluated individually using a 5-point scale that ranged as 0=No evidence of sign, 1=slight evidence, 2=moderate evidence, 3=marked evidence and 4=very marked, most severe evidence of sign) of erythema, induration and desquamation in each of the same 4 areas. PASI score ranges from 0(no psoriasis) to 72(worse psoriasis). Final PASI=(sum of severity score for each area)x(% body affected score x area score). Baseline=Day 1. The change from Baseline was the difference between post-Baseline and Baseline.|From Baseline (Day 1) until Week 12|ITT Population. Only those participants available at the specified time points were analyzed.||Scores on a Scale||Standard Deviation|Mean
666044|NCT01763905|Secondary|Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full anlaysis set||percent change||Standard Error|Least Squares Mean
664726|NCT01782664|Secondary|Number of Participants With the Indicated Maximum Change From Baseline in the Electrocardiogram (ECG) Findings|ECG measurements were obtained using single 12-lead ECGs with the participant in a supine position after resting in this position for at least 10 minutes. The Baseline values were those values obtained Pre-dose on Day 1. The change from Baseline was the difference between post-Baseline and Baseline. The QT intervals (milliseconds [msec]) corrected for heart rate using Bazett's formula (QTcB) and Fridericia's formula (QTcF) are reported.|From Baseline (Day 1) until the Follow-up visit (Day 112)|ITT Population.||Participants|||Count of Participants
664727|NCT01782664|Secondary|Change From Baseline in Body Temperature|Vital sign monitoring included body temperature measurements. Body temperature measurements were taken in the supine position after 5 minutes of rest. Baseline is defined as the last result on or before the day of first dose. Change from Baseline was determined by subtracting the indicated time point value minus the Baseline value.|From Baseline (Day 1) until Week 16|ITT Population. Only those participants available at the specified time points were analyzed.||Celsius||Standard Deviation|Mean
664728|NCT01782664|Secondary|Number of Participants With the Heart Rate Falling Outside the Clinical Concern Range at Any Time Post-Baseline (BL) During the Study|"Vital sign monitoring included heart rate (HR) measurements. HR measurements were taken in supine position after 5 minutes of rest. The number of participants with HR outside the clinical concern range at any time post-BL are presented. HR low was any HR less than 40 beats per minute (bpm) and high was any HR greater than 110 bpm. The BL values were those values obtained at Day 1. Anytime post-BL assessments included any scheduled and unscheduled post-BL assessment."|From Baseline (Day 1) until the Follow-up visit (Day 112)|ITT Population. Only those participants available at the specified time points were analyzed.||Participants|||Number
664729|NCT01782664|Secondary|Number of Participants With the Systolic (S) and Diastolic (D) Blood Pressure (BP) Falling Outside the Clinical Concern Range at Any Time Post-baseline During the Study|"Vital sign monitoring included systolic and diastolic BP measurements. BP measurements were taken in the supine position after 5 minutes of rest. The number of participants with the SBP or DBP outside the clinical concern range at any time post-BL are presented. SBP low was measured as less than 85 millimeters of mercury (mmHg)and high was measured as greater than 160 mmHg. DBP low was measured as less than 45 mmHg and high was measured as greater than 100 mmHg. The BL values were those values obtained at Day 1. Anytime post-BL assessments included any scheduled and unscheduled post-BL assessment."|From Baseline (Day 1) until the follow-up visit (Day 112)|ITT Population. Only those participants available at the specified time points were analyzed.||Participants|||Number
664730|NCT01782664|Secondary|Number of Participants With the Indicated Clinical Chemistry Parameters Falling Outside the Reference Range at Any Time Post-Baseline (BL) During the Study|Safety and tolerability were assessed by measuring the clinical chemistry parameters such as creatinine and cystatin C. BL values were obtained at Day 1. The number of participants with the indicated hematology parameter data outside of the reference range (> high or < low) at any time post-BL, including unscheduled or scheduled assessments, are presented.|From Baseline (Day 1) until the Follow-up visit (Day 112)|ITT population. Only those participants available at the specified time points were analyzed.||Participants|||Number
664731|NCT01782664|Secondary|Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During Study|Hematology parameters included: basophils, eosinophils, erythrocyte mean corpuscular hemoglobin (EMCHb) EMCHb concentration (EMCHbC), erythrocyte mean corpuscular volume (EMCV), erythrocyte sedimentation rate (ESR), erythrocytes, hematocrit (fraction 1), hemoglobin, leukocytes, lymphocytes, monocytes, neutrophils, segmented neutrophils, platelets, reticulocytes. BL values were obtained at Day 1. The number of participants with the indicated hematology parameters data outside of the reference range (with high and low) any time post-BL are presented. Anytime post-BL assessments included any scheduled and unscheduled post-BL assessment.|From BL (Day 1) until the Follow-up visit (Day 112)|ITT Population. Only those participants available at the specified time points were analyzed. Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Participants|||Number
664732|NCT01782664|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, is a congenital anomaly or birth defect. Any SAEs assessed as related to study participation (e.g. study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy) or related to a GSK product was recorded from the time a participant consents to participate in the study up to and including any follow-up contact.|From Baseline (Day 1) until the Follow-up visit (Day 112)|ITT Population||Participants|||Number
664733|NCT01782664|Primary|Percentage of Participants Who Had Achieved >=75% Improvement From Baseline in the Psoriasis Area Severity Index (PASI) Score at Week 12 (PASI 75)|PASI score was determined by evaluation of BSA covered by plaque psoriasis in 4 areas (head/neck, arms, trunk and legs with area score of 0.1, 0.2, 0.3 and 0.4 respectively). This test included combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale such that 0=0% involvement, 1=1-9%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89% and 6=90-100%) and severity (evaluated individually using a 5-point scale that ranged as 0=No evidence of sign, 1=slight evidence, 2=moderate evidence, 3=marked evidence and 4=very marked, most severe evidence of sign) of erythema, induration and desquamation in each of the same 4 areas. PASI score ranges from 0(no psoriasis) to 72(worse psoriasis). Final PASI=(sum of severity score for each area)x(% body affected score x area score). Baseline=Day 1. Percentage of participants who achieved >= 75% improvement from Baseline was reported with LOCF analysis.|Baseline and Week 12|Per-Protocol Population: Participants in the ITT analysis set who had no major protocol deviations.||Percentage of participants|||Number
664744|NCT01782326|Secondary|Change From Baseline in the Safety of QVA149 ((110/50 μg o.d.) vs Fluticasone/Salmeterol (500/50μg Bid) in Terms of HPA Axis Function, as Determined by Collection of 24-hour Urine Cortisol.|Urine cortisol/creatinine ratio|Baseline, 52 Weeks|Urine cortisol set is the subset of patients who were measured with 24-hour Urine cortisol, a subset of safety set. The safety set included all patients who received at least one dose of study drug. At the post-baseline timepoint only patients with a value at both baseline and the post-baseline timepoint are included.||ng/mL||Full Range|Median
664734|NCT01782664|Primary|Percentage of Participants Who Had Achieved >=75% Improvement From Baseline in the Psoriasis Area Severity Index (PASI) Score at Week 12 (PASI 75)|PASI score was determined by evaluation of body surface area (BSA) covered by plaque psoriasis in 4 areas (head/neck, arms, trunk and legs with area score of 0.1, 0.2, 0.3 and 0.4 respectively). This test included combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale such that 0=0% involvement, 1=1-9%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89% and 6=90-100%) and severity (evaluated individually using a 5-point scale that ranged as 0=No evidence of sign, 1=slight evidence, 2=moderate evidence, 3=marked evidence and 4=very marked, most severe evidence of sign) of erythema, induration and desquamation in each of the same 4 areas. PASI score ranges from 0(no psoriasis) to 72(worse psoriasis). Final PASI=(sum of severity score for each area)x(% body affected score x area score). Baseline=Day 1. Percentage of participants who achieved >= 75% improvement from Baseline was reported with last observation carried forward (LOCF) analysis.|Baseline and Week 12|Intent-to-Treat (ITT) Population: participants who received at least one dose of study medication.||Percentage of participants|||Number
664735|NCT01782482|Secondary|Positive Purchase Intent|"As reported on a questionnaire in response to, Assuming these lenses were at a price you would expect to pay, how likely would you be to purchase these lenses? The binary 'positive' vs 'negative' response variable was derived from a 5-point Likert scale. Positive purchase intent is reported as the percentage of participants choosing Definitely would purchase or Probably would purchase."|Day 7|The analysis population includes all randomized participants who satisfied specific Inclusion/Exclusion Criteria, did not sleep overnight in study lenses, and used only the habitual lens care during the study. The actual sample size used in calculating the outcome measure may be smaller due to missing responses and/or visit attendance.||Percentage of participants|||Number
664736|NCT01782482|Primary|Subjective Rating of Overall Satisfaction|Overall satisfaction, as rated by the participant on a 10-point scale, with 1 being very dissatisfied to 10 being very satisfied. The participant rated both eyes together by providing one single rating.|Day 7|The analysis population includes all randomized participants who satisfied specific Inclusion/Exclusion Criteria, did not sleep overnight in study lenses, and used only the habitual lens care during the study. The actual sample size used in calculating the outcome measure may be smaller due to missing responses and/or visit attendance.||Units on a scale||Standard Error|Mean
664737|NCT01782469|Secondary|Mean Change in Health Assessment Questionnaire (HAQ) Score|The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. The minimal clinically important difference (MCID) defined for the HAQ-DI is ≥0.22. HAQ remission indicating normal physical function is defined by HAQ-DI < 0.5. Negative mean changes from Baseline in the overall score indicate improvement. Due to an error, HAQ data was not collected at 13 weeks.|Baseline (Visit 1) to 13 weeks|Due to an error, HAQ data was not collected at 13 weeks. Therefore, only baseline data are reported.||units on a scale||Standard Deviation|Mean
664738|NCT01782469|Secondary|Percentage of Participants Who Achieved ≥ 20% Improvement in Both Tender Joint Count (TJC) and Swollen Joint Count (SJC)|The American College of Rheumatology TJC and SJC was administered at each study visit. Participants were evaluated for tenderness and pain in 66 different joints when in motion (TJC), and 68 different joints were evaluated for swelling (SJC).|Baseline (Visit 1) to 13 weeks|All enrolled participants||percentage of participants||95% Confidence Interval|Number
664739|NCT01782469|Secondary|Mean Number of Joints With Detected Erosions|A total of 12 joints (elbow, wrist, second metacarpal (MCP), third MCP, knee and ankle on both left and right sides) were assessed by ultrasonography at each study visit and the number of joints with erosion (wearing away) was documented.|Baseline (Visit 1) to 13 weeks|Participants with available data||joints||Standard Deviation|Mean
664740|NCT01782469|Secondary|Mean Percent Reduction in Ultrasonography Assessment Score|Synovitis was scored on a scale of 0 to 3 (0=none, 1=minor, 2=moderate, and 3=major presence). The sum of the scores of all 12 joints (elbow, wrist, second metacarpal (MCP), third MCP, knee and ankle on both left and right sides) is the ultrasonography assessment score, with a score range of 0-36.|Baseline (Visit 1) to 13 weeks|Participants with available data||Percent reduction||Standard Deviation|Mean
664741|NCT01782469|Primary|Mean Change in Synovitis Measured by B-modal Ultrasonography Assessment Score After 13 Weeks of Treatment With Adalimumab.|Synovitis was scored on a scale of 0 to 3 (0=none, 1=minor, 2=moderate, and 3=major presence). The sum of the scores of all 12 joints (elbow, wrist, second metacarpal (MCP), third MCP, knee and ankle) on both left and right sides is the ultrasonography assessment score, with a score range of 0-36.|Baseline (Visit 1) to 13 weeks|Participants with available data||units on a scale||Standard Deviation|Mean
664742|NCT01782326|Secondary|Number of Patients With Adverse Events, Serious Adverse Events, and Death|The overall rate of adverse events reported from initiation through 30 days post last dose.|52 weeks of treatment + 30 days|The Safety set:all patients that received at least one dose of study medication and had at least one post-baseline safety assessment. Patients were analyzed according to treatment received. The statement that a patient had no AEs also constituted a safety assessment. Only deaths occurring on treatment + 30 days after end of treatment were included||Number of participants|||Number
664743|NCT01782326|Secondary|Change From Baseline in Forced Vital Capacity|Change from baseline in trough value (average of values measured 45 and 15 minutes prior to the morning dose). Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FVC was defined as the average of the pre-dose FVC measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FVC measurements, smoking status at screening, screening inhaled corticosteroid (ICS) use, region, baseline FVC * visit interaction, and visit, treatment * visit interaction|4 Weeks, 12 Weeks, 26 Weeks, 38 Weeks, 52 Weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in MMRM are included||Liters||Standard Error|Least Squares Mean
664745|NCT01782326|Secondary|Change From Baseline in the Number of Puffs of Rescue Medication|A linear mixed model (LMM) was used for this analysis Change from baseline in mean number of puffs. LMM including: treatment, baseline value, smoking status at screening, ICS use at screening, airflow limitation severity, region and random effect of center nested within region.|Baseline, 52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug. Only FAS patients with non-missing values for all terms in LLM are included.||Number of puffs per day||Standard Error|Least Squares Mean
664746|NCT01782326|Secondary|Change From Baseline in Total St. George's Respiratory Questionnaire Score|The St. George Respiratory Questionnaire C (SGRQ-C) is a disease-specific measure of health status for use in COPD that was used to provide the health status measurements in this study. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline SGRQ-C total score, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, airflow limitation severity, visit, treatment*visit Interaction, baseline SGRQ-C total score*visit + region. lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status. A negative change from baseline indicates improvement.|Baseline, 52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in MMRM are included.||Score on a scale||Standard Error|Least Squares Mean
664747|NCT01782326|Secondary|Change From Baseline in Total St. George's Respiratory Questionnaire Score|The St. George Respiratory Questionnaire C (SGRQ-C) is a disease-specific measure of health status for use in COPD that was used to provide the health status measurements in this study. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline SGRQ-C total score, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, airflow limitation severity, visit, treatment*visit Interaction, baseline SGRQ-C total score*visit + region. lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status. A negative change from baseline indicates improvement.|Baseline, 38 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in MMRM are included.||Score on a scale||Standard Error|Least Squares Mean
664748|NCT01782326|Secondary|Change From Baseline in Total St. George's Respiratory Questionnaire Score|The St. George Respiratory Questionnaire C (SGRQ-C) is a disease-specific measure of health status for use in COPD that was used to provide the health status measurements in this study. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline SGRQ-C total score, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, airflow limitation severity, visit, treatment*visit Interaction, baseline SGRQ-C total score*visit + region. lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status. A negative change from baseline indicates improvement.|Baseline, 26 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in MMRM are included.||Score on a scale||Standard Error|Least Squares Mean
664749|NCT01782326|Secondary|Change From Baseline in Total St. George's Respiratory Questionnaire Score|The St. George Respiratory Questionnaire C (SGRQ-C) is a disease-specific measure of health status for use in COPD that was used to provide the health status measurements in this study. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline SGRQ-C total score, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, airflow limitation severity, visit, treatment*visit Interaction, baseline SGRQ-C total score*visit + region. lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status. A negative change from baseline indicates improvement.|Baseline, 12 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in MMRM are included.||Score on a scale||Standard Error|Least Squares Mean
664750|NCT01782326|Secondary|Change From Baseline in Total St. George's Respiratory Questionnaire Score|The St. George Respiratory Questionnaire C (SGRQ-C) is a disease-specific measure of health status for use in COPD that was used to provide the health status measurements in this study. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline SGRQ-C total score, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, airflow limitation severity, visit, treatment*visit Interaction, baseline SGRQ-C total score*visit + region. lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status. A negative change from baseline indicates improvement.|Baseline, 4 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug. Only FAS patients with non-missing values for all terms in MMRM are included.||Score on a scale||Standard Error|Least Squares Mean
664751|NCT01782326|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second AUC (0-12h)|Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction. The trapezoidal rule was used to calculate FEV1 AUC and then normalized to the length of time”|Baseline, 52 weeks|Serial spirometry set - Serial spirometry set includes the patients who performed additional serial spirometry, a subset of FAS. Only patients with non-missing values for all terms in MMRM are included.||Liters||Standard Error|Least Squares Mean
664752|NCT01782326|Secondary|Forced Expiratory Volume in 1 Second|Change from baseline in trough value. Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, airflow limitation severity, visit, treatment-by-visit interaction, and baseline FEV1-by-visit interaction.|Baseline, 52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in MMRM are included.||Liters||Standard Error|Least Squares Mean
664753|NCT01782326|Secondary|Forced Expiratory Volume in 1 Second|Change from baseline in trough value. Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, airflow limitation severity, visit, treatment-by-visit interaction, and baseline FEV1-by-visit interaction.|Baseline, 38 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in MMRM are included.||Liters||Standard Error|Least Squares Mean
664754|NCT01782326|Secondary|Forced Expiratory Volume in 1 Second|Change from baseline in trough value. Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, airflow limitation severity, visit, treatment-by-visit interaction, and baseline FEV1-by-visit interaction.|Baseline, 26 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in MMRM are included.||Liters||Standard Error|Least Squares Mean
664755|NCT01782326|Secondary|Forced Expiratory Volume in 1 Second|Change from baseline in trough value. Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, airflow limitation severity, visit, treatment-by-visit interaction, and baseline FEV1-by-visit interaction.|Baseline, 12 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in MMRM are included.||Liters||Standard Error|Least Squares Mean
664756|NCT01782326|Secondary|Forced Expiratory Volume in 1 Second|Change from baseline in trough value. Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, airflow limitation severity, visit, treatment-by-visit interaction, and baseline FEV1-by-visit interaction.|Baseline, 4 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and no major GCP violations. Only FAS patients with non-missing values for all terms in MMRM are included.||Liters||Standard Error|Least Squares Mean
664757|NCT01782326|Secondary|Forced Expiratory Volume in 1 Second|Change from baseline. Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, airflow limitation severity, region, visit, treatment-by-visit interaction, and baseline FEV1-by-visit interaction.|Baseline, day 1 (30 min and one hour post dose)|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and did not have any major GCP violations. Only FAS patients with non-missing values for all terms in MMRM are included.||Liters||Standard Error|Least Squares Mean
664758|NCT01782326|Secondary|Time to First Moderate to Severe COPD Exacerbations Requiring Re-hospitalization Within 30 Days|Cox regression model includes terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. COPD exacerbations starting between first dose and one day after date of last treatment are included.|52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in Cox regression model are included.||Days||95% Confidence Interval|Median
664759|NCT01782326|Secondary|Time to First Moderate to Severe COPD Exacerbations Requiring Hospitalization|Cox regression model includes terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. COPD exacerbations starting between first dose and one day after date of last treatment are included.|52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in Cox regression model are included.||Days||95% Confidence Interval|Median
664760|NCT01782326|Secondary|Time to First Moderate to Severe COPD Exacerbations Requiring Treatment With Antibiotics|Cox regression model includes terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. COPD exacerbations starting between first dose and one day after date of last treatment are included.|52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in Cox regression model are included.||Days||95% Confidence Interval|Median
664761|NCT01782326|Secondary|Time to First Moderate to Severe COPD Exacerbations Requiring Treatment With Systemic Corticosteroids|Cox regression model includes terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. COPD exacerbations starting between first dose and one day after date of last treatment are included.|52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in Cox regression model are included.||Days||95% Confidence Interval|Median
664762|NCT01782326|Secondary|Rate of Moderate to Severe COPD Exacerbations Requiring Re-hospitalization Within 30 Days|Re-hospitalizations are defined as hospitalizations starting within the first 30 days after a severe COPD exacerbation and between first dose and one day after date of last treatment. Generalized linear model assuming a negative binomial distribution with terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. The offset variable log(exposure time in years) was used. COPD exacerbations starting between first dose and one day after last treatment are included.|52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in negative binomial model are included.||COPD Exacerbation/year||Standard Deviation|Mean
664763|NCT01782326|Secondary|Rate of Moderate to Severe COPD Exacerbations Requiring Hospitalization. COPD Exacerbations Starting Between First Dose and One Day After Last Treatment Are Included.|All exacerbations requiring hospitalization are considered severe according to protocol definitions so this is the rate of severe COPD exacerbations only. Note - an ER visit of longer than 24 hours was considered a hospitalization.|52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in negative binomial model are included.||COPD Exacerbation/year||95% Confidence Interval|Least Squares Mean
664764|NCT01782326|Secondary|Rate of Moderate to Severe COPD Exacerbations Requiring Treatment With Antibiotics|Estimates are from a generalized linear model assuming a negative binomial distribution with terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. The offset variable log(exposure time in years) was used. COPD exacerbations starting between first dose and one day after last treatment are included .|52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug. Only FAS patients with non-missing values for all terms in negative binomial model are included.||COPD Exacerbation/year||95% Confidence Interval|Least Squares Mean
664765|NCT01782326|Secondary|Rate of Moderate to Severe COPD Exacerbations Requiring Treatment With Systemic Corticosteroids|COPD exacerbations starting between date of first dose and one day after last treatment are included. COPD exacerbations that occurred within 7 days of each other are collapsed as one event with the worst severity. Estimates are from a generalized linear model assuming a negative binomial distribution with fixed effects of treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. The offset variable log(exposure time in years) was used.|52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in negative binomial model are included.||COPD Exacerbation/year||95% Confidence Interval|Least Squares Mean
664766|NCT01782326|Secondary|Time to First Moderate to Severe COPD Exacerbation.|First COPD exacerbations starting between first dose and one day after last treatment are included. Cox regression model includes terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region.|52 weeks.|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in the Cox regression model are included.||Days||95% Confidence Interval|Median
664767|NCT01782326|Secondary|Rate of Moderate to Severe COPD Exacerbations.|COPD exacerbations starting between date of first dose and one day after last treatment are included. COPD exacerbations that occurred within 7 days of each other are collapsed as one event with the worst severity. A COPD exacerbation of moderate severity meets the symptoms definition in the protocol and requires treatment with systemic corticosteroids and/or antibiotics. A severe COPD exacerbation requires hospitalization. Estimates are from a generalized linear model assuming a negative binomial distribution with terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. The offset variable log(exposure time in years) was used.|52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in negative binomial model are included.||COPD Exacerbation/year||95% Confidence Interval|Least Squares Mean
664768|NCT01782326|Secondary|Time to First COPD Exacerbation.|First COPD exacerbations starting between first dose and one day after last treatment are included. Cox regression model includes terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region.|52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in Cox regression model are included.||Days||95% Confidence Interval|Median
664769|NCT01782326|Primary|Rate of COPD Exacerbations|COPD exacerbations starting between first dose and one day after last treatment are included. COPD exacerbations that occurred within 7 days of each other are collapsed as one event. Estimates are from a generalized linear model assuming a negative binomial distribution with terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. As the offset variable log(exposure time in years) was used.|52 weeks|The per-protocol set (PPS) included all patients in the FAS without any major protocol deviations. Only PPS patients with non-missing values for all terms in negative binomial model are included.||COPD Exacerbations/year||95% Confidence Interval|Least Squares Mean
664790|NCT01781481|Primary|Number of Extra Appointments With the IBD Team|Number of extra appointments (unscheduled, emergency) with the IBD Team during the 3 month period prior to the Pediatric INTERMED interview.|Data collected through chart review with respect to the three month period prior to Day 1 (date of patient's participation in Pediatric Intermed interview)|||Number of appointments||Full Range|Median
664770|NCT01782222|Secondary|Change From Baseline to the End of the Maintenance Period in the Score of the Clinical Global Impression Scale (CGI) Item I (Severity of Illness)|"The Clinical Global Impression (CGI) scales (Guy and Bonato, 1970) were initially developed for a risk-benefit estimation within the treatment of mentally ill patients. The 4 global scales (severity of illness, change in severity from Baseline, therapeutic efficacy, and tolerability of treatment) are used as different measures of treatment outcome in different kinds of pharmacological studies.
The CGI Item 1 (severity of illness) collected 1 answer out of 8 categories (0-‘Not assessed’, 1-‘Normal, not at all ill’, 2-‘Borderline ill’, 3-‘Mildly ill’, 4-‘Moderately ill’, 5-‘Markedly ill’, 6-‘Severely ill’, and 7-‘Among the most extremely ill patients’) at each assessment. The category 0-‘Not assessed’ was considered as missing and therefore used neither for calculation nor for display purposes."|Baseline (Visit 2) until End of the Maintenance Period/Early Withdrawal (up to 19 weeks after Baseline)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS included all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement for both primary efficacy variables.||participants|||Number
664771|NCT01782222|Secondary|"Change From Baseline to the End of the Maintenance Period in the Sum Score of the Unified Parkinson's Disease Rating Scale (UPDRS) Part III (Motor Subscale) in on State"|"Part III of the Unified Parkinson's Disease Rating Scale (UPDRS) assesses motor function. The UPDRS is completed by questioning the subject about his/her general state in conjunction with any observations made by the investigator (or designee) since the previous visit.
The UPDRS Part III (motor subscale) had to be measured in the “on” state and consisted of 27 items and sub items scored between 0 and 4. The sum score ranged between 0 and 108 and was calculated as sum of the 27 individual scores. If 1 or more items were missing and could not be substituted with a previous post-Baseline value, the sum score was also missing.
A negative value indicates an improvement."|Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS included all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement for both primary efficacy variables.||scores on a scale||Standard Deviation|Mean
664772|NCT01782222|Secondary|Change From Baseline to the End of the Maintenance Period in the Sum Score of the Beck Depression Inventory Second Edition (BDI-II)|The Beck Depression Inventory (BDI) is a self-report instrument to measure depression symptoms and severity (Beck et al, 1961). The BDI-II is a revised version of the scale in order to be more consistent with the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for depression (Beck et al, 1996). There are 21 items in the BDI-II, classified as cognitive-affective (Items 1-13) and somatic-performance (Items 14-21) subscales. The degree of severity is indicated on a 4-point scale; items are rated from 0 (not at all) to 3 (extreme form of each symptom). Scores of 0-13 indicate minimal depression, 14-19 indicate mild depression, 20-28 indicate moderate depression, and 29-63 indicate severe depression.|Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS included all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement for both primary efficacy variables.||scores on a scale||Standard Deviation|Mean
664773|NCT01782222|Secondary|Change From Baseline to the End of the Maintenance Period in the Sum Score of the Snaith Hamilton Pleasure Scale (SHAPS)|The Snaith Hamilton Pleasure Scale (SHAPS) (Snaith et al, 1995) is a self-report instrument developed for the assessment of hedonic capacity. The sum of the 14 items scores range from 0 to 14. A higher score represents more anhedonic symptoms.|Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS included all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement for both primary efficacy variables.||scores on a scale||Standard Deviation|Mean
664774|NCT01782222|Secondary|Change From Baseline to the End of the Maintenance Period in the Sum Score of the Mood / Cognition Domain of the Nonmotor Symptom Assessment Scale (NMSS)|"Nonmotor performance was assessed via the Nonmotor Symptom Assessment Scale (NMSS), an accepted scale that has been validated in an international study (Naidu et al, 2006; Chaudhuri et al, 2007), at the Baseline Visit as well as at the end of the Maintenance Period. The severity and frequency of the subject’s nonmotor symptoms were assessed by the investigator (or designee) in the following 9 domain categories: cardiovascular, including falls; sleep/fatigue; mood/cognition; perceptual problems/hallucinations; attention/memory; gastrointestinal tract; urinary; sexual function; and miscellaneous.
Items are scored for severity (from 0 (none) to 3 (severe)) and frequency (from 1 (rarely) to 4 (very frequent )). The score was calculated as severity x frequency. The theoretical minimum is 0 (best possible outcome) and maximum total score is 360 points (worst possible outcome)."|Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS included all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement for both primary efficacy variables.||scores on a scale||Standard Deviation|Mean
664775|NCT01782222|Secondary|Change From Baseline to the End of the Maintenance Period in the Sum Score of the 8-item Parkinson's Disease Questionnaire (PDQ-8)|The 8-Item Parkinson's Disease Questionnaire (PDQ-8) (Peto et al, 1998) is a self-administered questionnaire that provides a reliable measure of overall health status. The PDQ-8 collects 8 items with 5 categories each (0=never, 1=occasionally, 2=sometimes, 3=often, 4=always or cannot do at all). The total score was calculated by summing the scores of all applicable questions and convert the resulting sum to a summary index score between 0 and 100 by multiplying with 100/32. A negative value indicates an improvement.|Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS included all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement for both primary efficacy variables.||scores on a scale||Standard Deviation|Mean
664776|NCT01782222|Secondary|Change From Baseline to the End of the Maintenance Period in the Score of the Apathy Evaluation Scale (AS) Rated by the Caregiver (Where Available)|"The Apathy Scale (AS) is an abbreviated version of the Apathy Evaluation Scale. The AS (Starkstein et al, 1992) consists of 14 items phrased as questions by the examiner that are to be answered on a 4-point Likert scale. It was developed specifically for subjects with Parkinson’s disease because the Apathy Evaluation Scale was considered too demanding.
The questions comprising the AS were answered by the caregiver. The questions were asked in a structured interview format. The caregiver was interviewed by appropriate medical staff and asked questions about the subject in the third person.The total scores for Apathy Evaluation Scale ranges from 0 (best possible outcome) to 42 (worst possible outcome)."|Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS included all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement for both primary efficacy variables.||scores on a scale||Standard Deviation|Mean
664777|NCT01782222|Primary|Change From Baseline to the End of the Maintenance Period in the Total Score of the Unified Parkinson's Disease Rating Scale (UPDRS) Parts II (Activities of Daily Living) + III (Motor Symptoms)|Part II of the Unified Parkinson's Disease Rating Scale (UPDRS) assesses the subject’s activities of daily living. Part III assesses motor function. The UPDRS is completed by questioning the subject about his/her general state in conjunction with any observations made by the investigator (or designee) since the previous visit. Part II is subject-rated and Part III is physician-rated. The UPDRS Part II (Activities of Daily Living) consists of 13 items scored between 0 and 4. The sum score was calculated as the sum of these 13 individual scores. The UPDRS Part III (motor subscale) consists of 27 items and sub items scored between 0 and 4. The sum score was calculated as sum of these 27 individual scores. The sum score of UPDRS Parts II and III is the sum of the corresponding single sum scores. A negative value indicates an improvement.|Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS included all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement for both primary efficacy variables.||scores on a scale||Standard Deviation|Mean
664778|NCT01782222|Primary|Change From Baseline to the End of the Maintenance Period in the Score of the Apathy Evaluation Scale (AS) Rated by the Patient|"The Apathy Scale (AS) is an abbreviated version of the Apathy Evaluation Scale. The AS (Starkstein et al, 1992) consists of 14 items phrased as questions by the examiner that are to be answered on a 4-point Likert scale. It was developed specifically for subjects with Parkinson’s disease because the Apathy Evaluation Scale was considered too demanding.
The questions comprising the AS were answered by the subject. The total scores for Apathy Evaluation Scale ranges from 0 (best possible outcome) to 42 (worst possible outcome)."|Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS included all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement for both primary efficacy variables.||scores on a scale||Standard Deviation|Mean
664779|NCT01781962|Secondary|Number of Study Eyes in Each Step Grade Using Gonioscopic Lens|The angle width formed between the cornea and iris in both eyes was measured by gonioscopy using Large Step Grading ranging from 1.0 (smallest angle width) to 7.5 (largest angle width) with 0.5 unit intervals where each Large Step unit represented a fixed length of approximately 200 µm. The number of eyes in each Large Step Grade is reported.|Day 1|Participants from the mITT population, all enrolled patients with both gonioscopy and AS OCT measurements, with data available for this outcome measure.||eye|Participants||Number
664780|NCT01781962|Secondary|Number of Study Eyes in Each Shaffer Grade Using Gonioscopic Lens|The angle width formed between the cornea and iris in both eyes was measured by gonioscopy using Shaffer grading where: grade 4=wide open, grade 3=moderately open, grade 2=moderately narrow, grade 1=very narrow or grade 0=closed. The number of eyes in each Shaffer Grade is reported.|Day 1|Participants from the mITT population, all enrolled patients with both gonioscopy and AS OCT measurements, with data available for this outcome measure.||eye|Participants||Number
664781|NCT01781962|Primary|Anterior Angle Width Using Anterior Segment Optical Coherence Tomography (AS OCT)|The angle width formed between the eye's cornea and iris in both eyes was measured in microns (µm) using AS OCT, a laser-based, noninvasive, diagnostic system providing high-resolution images of the eye.|Day 1|Participants from the Modified Intent-to-treat (mITT) population, all enrolled patients with both gonioscopy and AS OCT measurements, with evaluable data for this outcome measure.||µm|Participants|Standard Deviation|Mean
664782|NCT01781806|Other Pre-specified|HIV Seroconversion and Treatment-emergent Resistance|Number and rate of HIV seroconversions, and treatment emergent resistance mutations, viral set point, and subsequent response to ART-treatment|Baseline to 48 weeks|||Participants|||Count of Participants
664783|NCT01781806|Other Pre-specified|Change in Transmission-risk Behavior|Changes in sexual risk behavior as assessed via CASI-based self-report questionnaire, measured longitudinally over time.|Baseline to 48 weeks||||||
664784|NCT01781806|Secondary|Adherence to Daily FTC/Tenofovir|Daily FTC/Tenofovir adherence, as measured by self-report, medication possession ratio (MPR), and levels of FTC-TP and/or TFV-DP in serum (detectable or undetectable) and erythrocytes via dried blood spots.|Baseline to 48 weeks||||||
664785|NCT01781806|Primary|Safety: Adverse Events/Serious Adverse Events|Number and frequency rate of clinical and laboratory AEs (Gr 2 and above) and SAEs|Baseline to 48 weeks|||Participants|||Count of Participants
664786|NCT01781637|Secondary|Pass 4000 mg OFC 12 Weeks After Last Dose of Omalizumab/Placebo||12 weeks after last dose of omalizumab/placebo|||Participants|||Count of Participants
664787|NCT01781637|Primary|Tolerance of 2000 mg 6 Weeks After Last Dose of Omalizumab/Placebo||6 weeks after last dose of omalizumab/placebo|||Participants|||Count of Participants
664788|NCT01781481|Primary|Number of Inpatient Hospital Admissions|Total number of times that the patient was admitted to hospital during the 3-month period prior to the Pediatric INTERMED Interview.|Data collected through chart review with respect to the three month period prior to Day 1 (date of patient's participation in Pediatric Intermed interview)|||Number of hospital admissions||Full Range|Median
664791|NCT01781481|Primary|Number of Calls to IBD Nurse|Total number of calls made by patient or parent to the IBD clinic nurse during the 3-month period prior to the Pediatric Intermed Interview|Data collected through chart review with respect to the three month period prior to Day 1 (date of patient's participation in Pediatric Intermed interview)|||Number of calls||Full Range|Median
664792|NCT01781481|Primary|Total Number of Hospital Services Involved in Child's Care.|Measure of number of hospital services involved in each child's care during the three month period prior to the Pediatric INTERMED interview.|Data collected through chart review with respect to the three month period prior to Day 1 (date of patient's participation in Pediatric Intermed interview)|||R Square change statistic||Full Range|Median
664793|NCT01781481|Primary|Correlations Between Pediatric Health System Domain Score/Items and Disease and Health Service Indicators|Refer to Outcome Measure 1 and Outcome Measure 3 for information pertaining to Pediatric INTERMED domain scores and items. Refer to Outcome Measure 6 for information pertaining to Disease/Treatment Indicators. Refer to Outcome Measure 23 for information about the Number of Services involved in Child's Care, and to Outcome Measure 15 for information about the Family Inventory of Resources for Management.|Pediatric INTERMED and FIRM scores obtained at Study Entry and Disease and Health Care Indicators since IBD Diagnosis|||Correlation Coefficients|||Number
664794|NCT01781481|Primary|Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's CBCL Externalizing Score is in the Clinical Range.|This outcome examined the increase in odds of a participant being identified as being rated as having a mental health need on the Pediatric INTERMED Mental Health/Cognitive Threat Item when they scored in the clinical range on the Child Behavior Checklist - Externalizing Problems Scale. Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED items. Refer to Outcome Measure 10 for information pertaining to the Child Behavior Checklist. Subjects were categorized into two groups based on their scores on Pediatric INTERMED Mental Health/Cognitive Threat ITEM: low psychological need (rating of 0 or 1) and high psychological need (rating of 2 or 3). Children with T scores above 63 on the Child Behavior Checklist Externalizing Scale were categorized as falling into the clinical range.|Day 1 (At time of Pediatric Intermed Interview)|The number of participants was lower due to some missing data for the CBCL measure, due to fewer participants completing this questionnaire.||participants|||Number
664795|NCT01781481|Primary|Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's CBCL Internalizing Score Falls in the Clinical Range.|This outcome examined the increase in odds of a participant being identified as being rated as having a mental health need on the Pediatric INTERMED Mental Health/Cognitive Threat Item when they scored in the clinical range on the Child Behavior Checklist - Internalizing Problems Scale. Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED items. Refer to Outcome Measure 10 for information pertaining to the Child Behavior Checklist. Subjects were categorized into two groups based on their scores on Pediatric INTERMED Mental Health/Cognitive Threat ITEM: low psychological need (rating of 0 or 1) and high psychological need (rating of 2 or 3). Children with T scores above 63 on the Child Behavior Checklist Internalizing Scale were categorized as falling into the clinical range.|Day 1 (At time of Pediatric Intermed Interview)|The number of participants was lower due to some missing data for the CBCL measure, due to fewer participants completing this questionnaire.||participants|||Number
664796|NCT01781481|Primary|Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's Total Children's Depression Inventory (CDI) Score is in the Clinical Range.|This outcome examined the increase in odds of a participant being identified as being rated as having a mental health need on the Pediatric INTERMED Mental Health/Cognitive Threat Item when they scored in the clinical range on the Children's Depression Inventory. Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED items. Refer to Outcome Measure 11 for information pertaining to the Children's Depression Inventory. Subjects were categorized into two groups based on their scores on Pediatric INTERMED Mental Health/Cognitive Threat ITEM: low psychological need (rating of 0 or 1) and high psychological need (rating of 2 or 3). Children with T scores above 65 on the Children's Depression Inventory were categorized as falling into the clinical range.|Day 1 (At time of Pediatric Intermed Interview)|The number of participants was lower due to some missing data for the CDI measure, due to fewer participants completing this questionnaire.||participants|||Number
664797|NCT01781481|Primary|Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's Total MASC Score Falls in the Clinical Range.|This outcome examined the increase in odds of a participant being identified as being rated as having a mental health need on the Pediatric INTERMED Mental Health/Cognitive Threat item when they scored in the clinical range on the Multidimensional Anxiety Scale for Children. Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED items. Refer to Outcome Measure 12 for information pertaining to the Children's Depression Inventory. Subjects were categorized into two groups based on their scores on Pediatric INTERMED Mental Health/Cognitive Threat ITEM: low psychological need (rating of 0 or 1) and high psychological need (rating of 2 or 3). Children with T scores above 65 on the Multidimensional Anxiety Scale for Children were categorized as falling into the clinical range.|Day 1 (At time of Pediatric Intermed Interview)|The number of participants was lower due to some missing data for the MASC measure, due to fewer participants completing this questionnaire.||participants|||Number
664798|NCT01781481|Primary|Correlations Between Pediatric Psychological, Social and Family Domain Scores and Measures of Emotional, Behavioural, Social and Family Functioning.|Relations between Pediatric INTERMED Psychological, Social and Family Domain scores and other validated measures of subjects' psychosocial adjustment, including depression (Children's Depression Inventory- Outcome Measure 11), anxiety (Multidimensional Anxiety Scale for Children-Outcome Measure 12), Behavioural Adjustment (Internalizing and Externalizing Scores on the CBCL- Outcome Measure 10), Competence (Social, Activities and School Competence Scores from the CBCL- Outcome Measure 10), and family functioning (Parenting Inventory for Parents- Outcome Measure 13, Family Inventory of Life Events-Outcome Measure 14, Family Inventory of Resources for Management- Outcome Measure 15), and IBD health-related quality of life (IMPACT III: Emotional Functioning and Social Interactions scales- Outcome Measure 9).|Day 1 (Time of Study Participation)|||Pearson Correlation Coefficient|||Number
664865|NCT01780922|Primary|Superoxide Dismutase (SOD) Activity in Red Blood Cells||0, 2, 4, 8, 24 h|||mU/mg HgB||Standard Error|Mean
664866|NCT01780922|Primary|Reduced Glutathione (GSH) Concentrations in Red Blood Cells||0, 2, 4, 8, 24 h|||mmol/L||Standard Error|Mean
664799|NCT01781481|Primary|Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning|Refer to Outcome Measure 1 and Outcome Measure 3 for information pertaining to Pediatric INTERMED domains and items. Refer to Outcome Measure 4 for information pertaining to IBD Disease Severity. Refer to Outcome Measure 5 for information pertaining to Disease Treatments. Refer to Outcome Measure 8 for information pertaining to Functioning Disability Inventory. Refer to Outcome Measure 9 for information pertaining to the IMPACT III- Quality of Life Questionnaire.|Pediatric INTERMED and Functioning at study participation and Disease related indices since IBD Diagnosis|||Correlation Coefficients|||Number
664800|NCT01781481|Primary|Family Inventory of Resources for Management|Family Inventory of Resources for Management (FIRM): (McCubbin & Comeau 1991). The FIRM was developed to assess the family's repertoire of resources. The scale is comprised of 69 items, which are responded to using a 4-point Likert scale format (0-3). The scale has been found to have good internal reliability (r=.89, Cronbach's alpha), content and concurrent validity when used in normative sample of families with chronically ill children. The possible range for the total score is from 0-207, with higher scores indicating greater family resources for management. The Financial Well-Being subscale consists of 16 items, with potential scores ranging from 0-48, with higher scores indicating greater family financial resources.|Day 1 (Date of patient's participation in the Pediatric Intermed interview).|The number of participants was lower due to some missing data for this outcome measure, as a result of a few parents not having completed this questionnaire.||units on a scale||Inter-Quartile Range|Median
664801|NCT01781481|Primary|Family Inventory of Life Events and Changes|Family Inventory of Life Events and Changes (FILE): (McCubbin & Patterson, 1991). The FILE is a 71-item, yes/no instrument that assesses chronic and recent life stress in nine areas: intra-family strains, marital strains, pregnancy and childbearing strains, finance and business strains, work-family transitions and strains, illness and family care strains, losses, transition in and out, and family and legal violations. Family members indicate whether particular stressful events have occurred. The FILE has been found to have high reliability (Cronbach's alpha=.72), good test-retest reliability, internal consistency and evidence of construct validity. Scores can range from 0-71, with higher scores indicating greater family stress.|Day 1 (Date of patient's participation in the Pediatric Intermed interview).|The number of participants was lower due to some missing data for this outcome measure, as a result of a few parents not having completed this questionnaire.||units on a scale||Inter-Quartile Range|Median
664802|NCT01781481|Primary|Pediatric Inventory for Parents- Difficulty Score|"Pediatric Inventory for parents: (PIP; Streisand et al., 2001). The PIP is a 42-item self-report measure of parenting stress associated with caring for a medically ill child. It is the only published measure of parenting stress the specifically taps the experiences and stresses that parents face when caring for a medically ill child. The Difficulty Score - indicates parents' perception of the perceived difficulty of each stressor/item. Each item is scored on a 5 point Likert scale, with total scores ranging from 42 to 210, with higher scores indicating greater perceived difficulty."|Day 1 (Date of patient's participation in the Pediatric Intermed interview).|The number of participants was lower due to some missing data for this outcome measure, as a result of a few parents not having completed this questionnaire.||units on a scale||Inter-Quartile Range|Median
664803|NCT01781481|Primary|Multidimensional Anxiety Scale for Children|"Multidimensional Anxiety Scale for Children: (MASC; March et a., 1997). The MASC is a pediatric self-report scale that measures symptoms of anxiety. It consists of 39 items assessing physical symptoms of anxiety, harm avoidance, social anxiety and separation/panic. Each item is answered using a four point Likert scale ranging from (0) never true about me to (3) often true about me. Total scores can range from 0 to 117. The raw total score was scaled to T-Scores to control for age and sex differences."|Day 1 (Date of patient's participation in the Pediatric Intermed interview).|The number of participants was lower due to some missing data for this outcome measure, as a result of a few participants not having completed this questionnaire.||units on a scale- T scores||Inter-Quartile Range|Median
664804|NCT01781481|Primary|Children's Depression Inventory|27 item self-report questionnaire used to measure depressive symptoms in children and youth (Kovacs 1992). Each item is rated on a 3-point Likert scale (0-2) with a minimum score of 0 and a maximum score of 54, with higher scores indicating more depressive symptoms. Raw scores were scaled to T-scores to control for age and gender differences.|Administered at study entry|The number of participants was lower due to some missing data for this outcome measure, as a result of a few participants not having completed this questionnaire.||Units on a Scale - T Scores||Inter-Quartile Range|Median
664805|NCT01781481|Primary|Child Behaviour Checklist|Child Behaviour Checklist: (CBCL: Achenbach 1991). The CBCL is used to evaluate behaviour problems and social competencies of children 6 to 18 years old. The measure is completed by parents or parent surrogates who base their ratings on the preceding 6 months. It is comprised of 120 problem items that factor into eight syndrome scales, which can be grouped into Internalizing, Externalizing and Total Problem Scales. Higher scores indicate greater level of emotional/behavioural difficulties. In the present study we utilized the following CBCL subscale scores: Internalizing, Externalizing, Social Competence, Activities Competence, Academic Competence. All scores reported are scaled to T Scores.|Day 1 (Date of patient's participation in the Pediatric Intermed interview).|The number of participants was lower due to some missing data for this indicator, as a result of a few parents not having completed this questionnaire.||Units on a Scale - T Scores||Inter-Quartile Range|Median
664806|NCT01781481|Primary|Impact-III: Quality of Life Questionnaire for Children With Inflammatory Bowel Disease.|35-item self report measure for assessing quality of life in children with IBD (Otley, Griffiths, Hale et al., 2006). Items are rated on a 5-point Likert scale, with lower scores indicating poorer health related quality of life. Scores can range from 35-175. Four factor scores can be calculated: General Well-Being, Emotional Functioning, Social Functioning, Body Image, as well as a Total Quality of Life Score (Perrin, Kuhlthau, Chughtai et al., 2008).|Day 1 (At time of Pediatric Intermed Interview)|The number of participants was lower due to some missing data for this indicator, due to a few participants not completing this questionnaire.||units on a scale||Inter-Quartile Range|Median
664867|NCT01780870|Primary|The Primary Outcome Will be HOMA-IR at Baseline and 8 Weeks|The secondary outcome was deleted, since it was finally not performed in the study due to problems in enrollment|8 weeks|||HOMA score||Standard Deviation|Mean
664868|NCT01780870|Primary|The Primary Outcome Will be Insulin Levels at Baseline and 8 Weeks|The secondary outcome was deleted, since it was finally not performed in the study due to problems in enrollment|8 weeks|||μU/ml||Standard Deviation|Mean
664807|NCT01781481|Primary|Functional Disability Inventory|"Functional Disability Inventory: (FDI); Walker & Greene, 1991). The FDI assesses illness related activity limitations in children and adolescents. The measure consists of 15 items that are scored by the child and parent as (0) no trouble to (4) impossible. The minimum score is 0 and the maximum score is 60, with higher scores indicating greater functional disability. The FDI has demonstrated good psychometric properties with test-retest reliability of .92 and .85 at the 3-month follow-up. Concurrent validity was provided by correlation (r=.52, p<.001) between the FDI and an objective index of disability (Walker & Greene, 1991)."|Day 1 (Date of patient's participation in the Pediatric Intermed interview).|||units on a scale||Full Range|Median
664808|NCT01781481|Primary|IBD Treatment With Immunomodulators or Anti-TNFa Medications|"Use of Immunomodulators (azathioprine or methotrexate). Coded for each participant as yes (Score of 1) or no (Score of 2). Use of anti-Tumor Necrosis Factor alpha (TNFa) medications (infliximab or adalimumab). Coded for each participant as yes (Score of 1) or no (Score of 2)."|Information from review of participants chart from time of diagnosis until study participation (date of Pediatric INTERMED interview).|||Percentage of participants treated|||Number
664809|NCT01781481|Primary|Disease Course and Treatment|Number of hospitalizations since diagnosis (total number recorded in health record), number of surgeries since diagnosis (total number recorded in health record), number of courses of Prednisone (total number recorded in health record).|Data collected through chart review with respect to the period since diagnosis and Day 1 (date that patient's participation in Pediatric Intermed interview)|||number of times it occurred||Full Range|Median
664810|NCT01781481|Primary|Time Since IBD Diagnosis|"Time since subject's initial IBD diagnosis. Data for each subject was obtained from chart review and was coded in months since date of diagnosis, with a range from 1 - 131 months."|Data collected through chart review at time of Pediatric INTERMED interview.|||Percentage of Participants|||Number
664811|NCT01781481|Primary|IBD Disease Severity|IBD Disease Severity Index categorizes patient's level of disease severity based on patient scores on the Pediatric Crohn's Disease Activity Index (PCDAI): (Hymans, Markowitz, Otley et al., 2005) and the Pediatric Ulcerative Colitis Activity Index (PUCAI) (Turner, Otley, Mack et al., 2007). Children's scores on either of these indices are used to categorize the severity of their disease as: inactive, mild, moderate, or severe.|Day 1 (Date of patient's participation in the Pediatric Intermed interview).|||percentage of participants|||Number
664812|NCT01781481|Primary|Pediatric INTERMED Items|Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED items.|Day 1 (At time of Pediatric Intermed Interview)|||Percentage of participants|||Number
664813|NCT01781481|Primary|Correlations Between Pediatric INTERMED Domain Scores|Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED domain scores.|Pediatric INTERMED scores at time of study participation|||Correlation Coefficient|||Number
664814|NCT01781481|Primary|Pediatric INTERMED- Complexity Index|"34 item screening tool which identifies biological, psychological, social, caregiver/family and health service needs that contribute to case complexity. Each item is rated on a scale from 0-3 (0= no need to act; 1= watchful waiting or preventive intervention, 2=need for action, 3=need for immediate action).
Minimum total score is 0 and Maximum score would be 102 (high complexity). Items on the Pediatric INTERMED are organized into 5 domains:
Biological Domain (6 items). Minimum score is 0 and maximum score is 18 (high biological complexity).
Psychological Domain (9 items). Minimum score is 0 and maximum score is 27 (high psychological complexity).
Social Domain (7 items). Minimum score is 0 and maximum score is 21 (high social complexity).
Family/Caregiver Domain (7 items). Minimum score is 0 and maximum score is 21 (high family/caregiver complexity).
Health Services Domain (5 items). Minimum score is 0 and maximum score is 15 (high health service complexity)."|Time of Study Participation (Completion of Pediatric INTERMED tool)|||scores on a scale||Inter-Quartile Range|Median
664815|NCT01781403|Other Pre-specified|Disease-free Survival||3-year or 5-year after surgery||||||
664816|NCT01781403|Other Pre-specified|Efficacy|"Efficacy: Pathologic major responses = total regression + near total regression.
We will carefully inspect the circumferential resection margin, defining a positive margin as any residual tumor within ≤ 1 mm of the circumferential margin.
Pathologic responses and stages will be classified according to Dworak’s classification1 and the AJCC (American Joint Committee on Cancer) staging system, respectively. In each case, the entire tumor including mesorectal fat will be serially sliced into 4-mm-thick sections and embedded in paraffin.
A pathologic complete response is defined as grade 4 tumor regression; with residual fibrotic mass or acellular mucin pools only, thus without detectable tumor cells
A near total response is defined as grade 3 tumor regression; with very few tumor cells in fibrotic tissue with or without mucous substance."|after surgery (6-8 weeks after study treatment)||||||
664817|NCT01781403|Other Pre-specified|Toxicity|"Toxicity will be monitored and recorded every week during study treatment (5 or 6 weeks) as following according to the NCI-CTCAE version 4.0
An interval history and physical examination with particular attention to drug-induced side effects along with documentation of the patient’s weight and performance status will be performed on each visit.
CBC with differential count, blood chemistry including calcium, phosphorus, glucose, BUN, creatinine, total protein, albumin, AST, ALT, alkaline phosphatase, total bilirubin, and electrolyte will be performed before next planned treatment.
All relevant information regarding drug dosage, laboratory examinations, and treatment-related toxicities must be recorded before each treatment is given.
Summaries of the frequency and severity of adverse effects are based on the worst episodes recorded."|5-6 weeks during study treatment|||events|||Number
664818|NCT01781403|Secondary|Pathological Complete Response|"Pathologic responses and stages were classified according to Dworak’s classification and the 7th edition of the American Joint Committee on Cancer staging system, respectively.
The pathologic complete response (pCR) was defined as the total regression of the primary tumor regardless of regional lymph nodal status (ypT0), with residual fibrotic mass or acellular mucin pools only, thus without detectable tumor cells."|at the time of surgery (6-8 weeks after study treatment)|||participants|||Number
664819|NCT01781403|Primary|Recommended Dose (RD)|RD will be defined as one level below the MTD.|5-6 weeks after CRT|||mg/m^2|||Number
664820|NCT01781403|Primary|Maximum Tolerated Dose (MTD)|The MTD is defined as the maximum dose level in the doses of temozolomide tested with capecitabine and radiation in which the incidence proportion of DLT exceeds 30%.|5-6 weeks during study treatment|||mg/m^2|||Number
664869|NCT01780870|Primary|The Primary Outcome Will be the Leptin Levels at Baseline and 8 Weeks|The secondary outcome was deleted, since it was finally not performed in the study due to problems in enrollment|8 weeks|||ng/ml||Standard Deviation|Mean
664821|NCT01781299|Secondary|Aesthetic Evaluation|Initial aesthetic evaluation will occur at approximately 6 weeks after permanent implant placement. Re-evaluation will occur at 1 and 3 years following permanent implant placement. This will involve physical examination, 2D photographs, and patient Breast-Q self-examination. Breast-Q examination is on a scale of 25-100 with 25 questions on a scale of 1-4 where 1 is very dissatisfied and 4 is very satisfied.|3 years following permanent implant placement.|discrepancy is caused by funding ending and no data was collected from SurgiMend arm.||units on a scale||Full Range|Mean
664822|NCT01781299|Primary|Complication Rates|To determine the complication rate for tissue expander breast reconstruction patients using SurgiMend PRS and AlloDerm RTU ADM products. Time points include: After first procedure: 10-14 days, then 2, 4, 6, and 10 weeks after drain removal; After second procedure: 1-2 weeks, 6 weeks, 1 year, and 3 years.|3 years|||Participants|||Count of Participants
664823|NCT01781208|Primary|ARFI/VTQ and ARFI/VTIQ Liver Shear Wave Speed vs. Liver Histologic Fibrosis Score|"Tissue shear wave speed is positively correlated to a material's/tissue's stiffness and can be noninvasively measured by ultrasound. The relationship between liver shear wave speed and liver histologic fibrosis score were assessed using 2 different ultrasound methods. Liver shear wave speed as obtained using 2 different ultrasound methods served as our primary outcome measures.
Note, the histologic scoring system (Ishak) ranged from 0 to 6, where 0 = no fibrosis and 6 = cirrhosis."|10 minutes|"49 pediatric subjects underwent successful (diagnostic) liver ARFI/VTQ) assessment and liver histologic fibrosis scoring. 13 subjects had non-diagnostic ARFI/VTQ exams.
48 pediatric subjects underwent successful (diagnostic) liver ARFI/VTIQ) assessment and liver histologic fibrosis scoring. 14 subjects had non-diagnostic ARFI/VTIQ exams."||m/s||Standard Deviation|Mean
664824|NCT01781169|Primary|Plasma 25-hydroxy Vitamin D (25(OH)D) Level (Nmol/L)||Endpoint and baseline of the 8 weeks' trial|||nmol/L||Standard Deviation|Mean
664825|NCT01781078|Secondary|Proportion of Participants Without ImageReady System-related Complications|Overall safety of the ImageReady System will be confirmed by evaluating system-related complications that occur from system implant through 3 months post implant for all subjects who underwent an implant procedure and and reached 91 days of follow-up.|3 months post implant|||Percentage of participants||95% Confidence Interval|Number
664826|NCT01781078|Primary|Success Rate for Sensed Amplitude Measurement at 1 Month Post-MRI Scan or Control Group Visit|The MRI scan can result in damage to cardiac tissue surrounding lead electrodes due to Radiofrequency (RF) field-induced heating. Primary Effectiveness Endpoint 2 will evaluate any chronic effects from lead heating that will be seen through decreased sensed amplitude at the MRI Visit + 1 Month follow-up. Data were analyzed separately by chamber, Right Atrium (RA) and Right Ventricle (RV), for this endpoint.|MRI + 1 Month Visit|Right Atrium: a total of 78 Control Group subjects and 135 MRI Group subjects had paired sensed amplitude measurements and met the inclusion criteria. Right Ventricle: a total of 91 Control Group subjects and 152 MRI Group subjects had paired sensed amplitude measurements and met the inclusion criteria.||% of participants with success|||Number
664827|NCT01781078|Primary|Success Rate for Threshold Measurement at 1 Month Post-MRI Scan or Control Group Visit|"The MRI scan can result in damage to cardiac tissue surrounding lead electrodes due to RF field-induced heating, which in turn may cause elevated pacing thresholds. Primary Effectiveness Endpoint 1 will evaluate any chronic effects from lead heating that will be seen through increased pacing threshold at the MRI Visit + 1 Month follow-up.
Subjects with an increase in pacing thresholds s 0.5V (at 0.5 ms) from pre-MR Scan/Control Group visit to MRI/Control visit + 1 Month follow-up were considered a success. A success rate was calculated for both the MRI and the Control Groups."|MRI + 1 Month Visit|For the per-protocol analysis, a total of 96 Control Group subjects and 167 MRI Group subjects had paired threshold measurements and met the inclusion criteria.||% of participants with success|||Number
664828|NCT01781078|Primary|Proportion of Participants Without MR Scan-related Complications|The primary safety endpoint for SAMURAI will be assessed for all subjects randomized to the MRI Group who undergo any portion of the MRI scan sequences. Safety will be confirmed by evaluating the MRI scan-related Complication-free rate (CFR) between the MR Scan and the MRI Visit + 1 Month Visit.|MRI Visit + 1 Month|The primary safety endpoint for SAMURAI will be assessed for all subjects randomized to the MRI Group who underwent any portion of the MRI scan sequences and did not have a medically necessary scan performed prior to the MRI visit + 1 month follow-up.||Percentage of participants||95% Confidence Interval|Number
664829|NCT01781026|Primary|Activity of Vemurafenib in Untreated Brain Metastases|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|1 year|Subjects withdrew prior primary outcome measurement therefore no data was obtained to report|||||
664830|NCT01780987|Secondary|Number of Participants With Adjudicated All Bleeding Events During the Treatment Periods|All bleeding events consisted of major bleeding (per Interactional Society on Thrombosis and Homeostasis ［ISTH］ Definition), clinically relevant non-major (CRNM) and minor bleeding. All acute clinically overt bleeding events not meeting the criteria for either major bleeding or CRMN bleeding were classified as minor bleeding.|Baseline to Week 24|The safety analysis set (SAS) consisted of all treated participants.||participants|||Number
664831|NCT01780987|Secondary|Number of Participants With Adjudicated Major Bleeding Events ［Per International Society on Thrombosis and Homeostasis (ISTH) Definition］During the Treatment Period|Major bleeding event was defined as an acute clinically overt bleeding accompanied by a decrease in hemoglobin of 2 g/dL or more, a transfusion of 4 or more units of packed red blood cells (a unit of packed red blood cells equal to about 200 cc), or bleeding that occurred in critical sites (e.g. intracranial). Fatal bleeding was also defined as a major bleeding event.|Baseline to Week 24|The safety analysis set (SAS) consisted of all treated participants.||participants|||Number
664832|NCT01780987|Secondary|Number of Participants With Adjudicated Thrombotic Burden Worsened in Acute Symptomatic Pulmonary Embolism (PE)|Computed tomography pulmonary angiography (CTPA) was used to assess thrombotic burden in the participants with PE and the results were classified as improved, no change, or worsened. The timings of CTPA examinations were Weeks 2, 12 and 24.|Baseline to Week 24|A subset of full analysis set (FAS) that consisted of participants with PE. n=number of participants evaluated.||participants|||Number
664870|NCT01780584|Other Pre-specified|Postoperative Hospital Length of Stay||up to 3 month after surgery|||days||Full Range|Median
664871|NCT01780584|Other Pre-specified|Postoperative Length of Stay in Intensive Care Unit||up to 3 months after surgery|||hours||Full Range|Median
664833|NCT01780987|Secondary|Number of Participants With Adjudicated Thrombotic Burden Worsened in Acute Symptomatic Proximal Deep Venous Thrombosis (DVT)|Computed tomography venography (CTV) and compression ultrasound (CUS) were used to assess thrombotic burden in the participants with DVT and the results were classified as improved, no change, or worsened. The timings of CTV and CUS examinations were at Week 12 and Weeks 2, 12 and 24.|Baseline to Week 24|A subset of full analysis set (FAS) that consisted of participants with DVT. n=number of participants evaluated.||participants|||Number
664834|NCT01780987|Secondary|Number of Participants With Adjudicated Recurrent Symptomatic Venous Thromboembolism (VTE) ［Nonfatal Deep Venous Thrombosis (DVT) or Nonfatal Pulmonary Embolism (PE)］ or VTE-Related Death During the Intended Treatment Period|"VTE-related death was defined as a death caused by documented PE which was diagnosed with objective testing or autopsy, or an unexplained death for which DVT/PE could not be ruled out as the cause. Intended Treatment Period was the period starting on the day of randomization and ending at either 2 days after the last dose of the study drug or Day 168/Week 24, whichever came late."|Baseline to Week 24|Full analysis set (FAS) was defined as all randomized participants. Participants with missing endpoint information were excluded from the analysis.||participants|||Number
664835|NCT01780987|Primary|Number of Participants With Major Bleeding Events ［Per International Society on Thrombosis and Homeostasis (ISTH) Definition］ or Clinically Relevant Non-major (CRNM) Bleeding Events Adjudicated by Clinical Event Committee During the Treatment Period|Major bleeding event was defined as an acute clinically overt bleeding accompanied by a decrease in hemoglobin of 2 g/dL or more, a transfusion of 4 or more units of packed red blood cells (a unit of packed red blood cells equal to about 200 cc), or bleeding that occurred in critical sites (e.g. intracranial). Fatal bleeding was also defined as a major bleeding event. CRNM bleeding event was defined as an acute clinically overt bleeding that did not satisfy the definition of major bleeding and that led to either hospitalization, physician guided medical or surgical treatment for bleeding, or a change in antithrombotic therapy.|Baseline to Week 24|The safety analysis set (SAS) consisted of all treated participants.||participants|||Number
664836|NCT01780974|Secondary|White Matter Hyperintensity Volume (Brain MRI)||Baseline and 12 months|At baseline, 4 participants either could not complete the MRI or the MRI could not be analyzed due to quality; at 12 months, 13 participants either discontinued, could not complete the MRI, or did not complete the baseline and therefore were not scanned.||cubic centimeters||Standard Deviation|Mean
664837|NCT01780974|Primary|Trails Making Test Part B (Executive Function)|"The trail Making Test consist of 25 circles distributed over a sheet of paper. In Part A, the circles are numbered 1 - 25, and the patient should draw lines to connect the numbers in ascending order. In Part B, the circles include both numbers (1 - 13) and letters (A - L); as in Part A, the patient draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters (i.e., 1-A-2-B-3-C, etc.). The patient should be instructed to connect the circles as quickly as possible, without lifting the pen or pencil from the paper. Time the patient as he or she connects the trail. If the patient makes an error, point it out immediately and allow the patient to correct it. Results for part B are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment."|Baseline, 6 months, and 12 months|Not all tests were completed by all randomized subjects due to missed visits and/or discontinuations.||time to completion (seconds)||Standard Deviation|Mean
664838|NCT01780935|Secondary|Frequency and Severity of Ocular and Non-ocular Adverse Events Over Time|During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.|Screening to Month 12 and 24|Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed|||||
664839|NCT01780935|Secondary|Change From Baseline in the National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) Scores Over Time|During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.|Baseline to Month 12 and 24|Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed|||||
664840|NCT01780935|Secondary|Treatment Patterns Over Time in Both Treatment Arms|During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.|Baseline to Month 12 and 24|Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed|||||
664841|NCT01780935|Secondary|Change From Baseline in Lesion Size and Morphology Based on Fluorescein Angiography at Month 12 and 24|During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.|Baseline to Month 12 and 24|Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed|||||
664842|NCT01780935|Secondary|Dry Retina in the Study Eye on OCT at Month 12 and 24|During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.|Month 12 and 24|Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed|||||
664872|NCT01780584|Other Pre-specified|Postoperative Time to Extubation|Postoperative time to extubation is length of time on ventilator.|up to 3 months after surgery|||hours||Full Range|Median
664843|NCT01780935|Secondary|Change From Baseline in Central Sub-Field Thickness (CSFT) and Central Sub-Field Volume (CSFV) of the Study Eye Over Time|During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.|Baseline to Month 12 and 24|Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed|||||
664844|NCT01780935|Secondary|Average Visual Acuity Change From Baseline to Month 1 Through Month 12 and 24 in the Study Eye|During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.|Baseline to Month 12 and 24|Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed|||||
664845|NCT01780935|Secondary|Average Visual Acuity Change From Month 3 to Month 4 Through Month 24 in the Study Eye|During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.|Month 3 to Month 24|Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed|||||
664846|NCT01780935|Secondary|Visual Acuity of 73 Letters or More in the Study Eye at Month 12 and 24|During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.|Month 12 and 24|Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed|||||
664847|NCT01780935|Secondary|Loss of Less Than 5, 10, and 15 Letters in Visual Acuity in the Study Eye From Baseline, at Month 12 and 24|During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.|Baseline to Month 12 and 24|Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed|||||
664848|NCT01780935|Secondary|Gain of Equal or More Than 1, 5, 10, or 15 Letters in Visual Acuity of the Study Eye From Baseline, at Month 12 and 24|During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.|Baseline to Month 12 and 24|Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed|||||
664849|NCT01780935|Secondary|Change From Baseline in Visual Acuity (Letters) of the Study Eye up to Month 12|Visual acuity (VA) was assessed using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like VA testing charts at a testing distance of 4 meters. This outcome measure describes the difference between the Visual Acuity averaged from Baseline to Month 12 Level of VA (Letters) of the Study Eye.|up to Month 12|Full Analysis Set (FAS) includes all randomized patients||letters correctly read||Standard Deviation|Mean
664850|NCT01780935|Primary|Average Best-corrected Visual Acuity (BCVA) (Letters) Change up to Month 12|Visual acuity (VA) was assessed during every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like VA testing charts at a testing distance of 4 meters. This outcome measure describes the difference between the Visual Acuity averaged up to Month 12 Level of VA (Letters) of the Study Eye.|up to Month 12|Full Analysis Set (FAS) includes all randomized patients||Letters correctly read||Standard Deviation|Mean
664851|NCT01780922|Primary|Urinary Anti-bacteria Adhesion Activity||0, 3, 6, 9, 12, 24 h|||mg PAC/mg creatinine||Standard Error|Mean
664852|NCT01780922|Primary|Tumor Necrosis Factor-alpha (TNF-a) Concentrations in Plasma||0, 2, 4, 8, 24 h|||pg/mL||Standard Error|Mean
664853|NCT01780922|Primary|Interferon-gamma (IFN-y) Concentrations in Plasma||0, 2, 4, 8, 24 h|||pg/mL||Standard Error|Mean
664854|NCT01780922|Primary|Interleukin-10 (IL-10) Concentrations in Plasma||0, 2, 4, 8, 24 h|||pg/mL||Standard Error|Mean
664855|NCT01780922|Primary|Interleukin-8 (IL-8) Concentrations in Plasma||0, 2, 4, 8, 24 h|||pg/mL||Standard Error|Mean
664856|NCT01780922|Primary|Interleukin-6 (IL-6) Concentrations in Plasma||0, 2, 4, 8, 24 h|||pg/mL||Standard Error|Mean
664857|NCT01780922|Primary|Interleukin-4 (IL-4) Concentrations in Plasma||0, 2, 4, 8, 24 h|||pg/mL||Standard Error|Mean
664858|NCT01780922|Primary|Interleukin-2 (IL-2) Concentrations in Plasma||0, 2, 4, 8, 24 h|||pg/mL||Standard Error|Mean
664859|NCT01780922|Primary|Interleukin-1beta (IL-1b) Concentrations in Plasma||0, 2, 4, 8, 24 h|||pg/mL||Standard Error|Mean
664860|NCT01780922|Primary|Interleukin-1alpha (IL-1a) Concentrations in Plasma||0, 2, 4, 8, 24 h|||pg/mL||Standard Error|Mean
664861|NCT01780922|Primary|Nitric Oxide (NO) Concentrations in Plamsa||0, 2, 4, 8, 24 h|||umol/L||Standard Error|Mean
664862|NCT01780922|Primary|C-Reactive Protein (CRP) Concentrations in Plamsa||0, 2, 4, 8, 24 h|||ug/mL||Standard Error|Mean
664863|NCT01780922|Primary|Oxidative Damage to DNA Assessed by Plasma 8-hydroxy-2’-Deoxyguanosine (8-OHdG)||0, 2, 4, 8, 24 h|||ng/mL||Standard Error|Mean
664864|NCT01780922|Primary|Glutathione Peroxidase (GPx) Activity in Red Blood Cells||0, 2, 4, 8, 24 h|||mU/mg HgB||Standard Error|Mean
664873|NCT01780584|Secondary|Number of Patients With Possible Side Effects of Thyroid Hormone Supplementation Particularly Suggesting Hyperthyroid Symptoms.|Specific symptoms of hyperthyroidism included cardiac dysrhythmia requiring medical or electrical treatment, hypertension (mean systolic or diastolic blood pressure more than 2 standard deviation above normal for age) and hyperthermia (>37.5 degree Celsius). One patient in low dose group had hypertension directly after surgery due to unrecognized coarctation of the aorta and this patient was withdrawal from the protocol.|Since the first dose of oral T3 until 7 days after surgery|Three patients were excluded from adverse effect analysis. Two patients, each in placebo and high dose group were on Extracorporeal Membrane Oxygenation. One patient in high dose group could not attained enteral feeds due to gastrointestinal bleeding and was withdrawal from the protocol.||participants|||Number
664874|NCT01780584|Primary|Free T3 (FT3) Levels|Free T3 levels were measured up to 36 hours after cross-clamp removal|during the first 36 hours after cross clamp removal|Two subjects (one in T3 low dose and one in T3 high dose) were withdrawn from the treatment protocol. The withdrawal in low dose group was because of severe hypertension caused by a previously unrecognized coarctation of the aorta, and the high dose group withdrawal was due to massive gastrointestinal bleeding.||pg/ml||Standard Error|Mean
664875|NCT01780506|Secondary|Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 96|Urine Beta-2-microglobulin is a renal biomarker which is used to detect drug-induced kidney injury.|Baseline; Week 96|Participants in the Safety Analysis Set with available data were analyzed.||percent change in ratio (µg/g)||Inter-Quartile Range|Median
664876|NCT01780506|Secondary|Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 48|Urine Beta-2-microglobulin is a renal biomarker which is used to detect drug-induced kidney injury.|Baseline; Week 48|Participants in the Safety Analysis Set with available data were analyzed.||percent change in ratio (µg/g)||Inter-Quartile Range|Median
664877|NCT01780506|Secondary|Percent Change From Baseline in Urine RBP to Creatinine Ratio at Week 96|Urine RBP is a renal biomarker which is used to detect drug-induced kidney injury.|Baseline; Week 96|Participants in the Safety Analysis Set with available data were analyzed.||percent change in ratio (µg/g)||Inter-Quartile Range|Median
664878|NCT01780506|Secondary|Percent Change From Baseline in Urine Retinol Binding Protein (RBP) to Creatinine Ratio at Week 48|Urine RBP is a renal biomarker which is used to detect drug-induced kidney injury.|Baseline; Week 48|Participants in the Safety Analysis Set with available data were analyzed.||percent change in ratio (µg/g)||Inter-Quartile Range|Median
664879|NCT01780506|Secondary|Percentage of Participants Experiencing Treatment-emergent Proteinuria Through Week 96|Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method. The worst postbaseline value is presented for each participant.|Up to 96 weeks|Participants in the Safety Analysis Set with at least 1 postbaseline urine protein value were analyzed.||percentage of participants|||Number
664880|NCT01780506|Secondary|Percentage of Participants Experiencing Treatment-emergent Proteinuria Through Week 48|Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method. The worst postbaseline value is presented for each participant.|Up to 48 weeks|Participants in the Safety Analysis Set with at least 1 postbaseline urine protein value were analyzed.||percentage of participants|||Number
664881|NCT01780506|Secondary|Change From Baseline in Serum Creatinine at Week 96||Baseline; Week 96|Safety Analysis Set. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.||mg/dL||Standard Deviation|Mean
664882|NCT01780506|Secondary|Change From Baseline in Serum Creatinine at Week 48||Baseline; Week 48|Safety Analysis Set. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.||mg/dL||Standard Deviation|Mean
664883|NCT01780506|Secondary|Percent Change From Baseline in Spine BMD at Week 96|Spine BMD was assessed by DXA scan.|Baseline; Week 96|Spine DXA Analysis Set. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.||percentage change in spine BMD (g/cm^2)||Standard Deviation|Mean
664884|NCT01780506|Secondary|Percent Change From Baseline in Spine BMD at Week 48|Spine BMD was assessed by DXA scan.|Baseline; Week 48|Spine DXA Analysis Set. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.||percentage change in spine BMD (g/cm^2)||Standard Deviation|Mean
664885|NCT01780506|Secondary|Percent Change From Baseline in Hip BMD at Week 96|Hip BMD was assessed by DXA scan.|Baseline; Week 96|Hip DXA Analysis Set. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.||percentage change in hip BMD (g/cm^2)||Standard Deviation|Mean
664886|NCT01780506|Secondary|Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48|Hip BMD was assessed by dual energy x-ray absorptiometry (DXA) scan.|Baseline; Week 48|Hip DXA Analysis Set. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.||percentage change in hip BMD (g/cm^2)||Standard Deviation|Mean
664887|NCT01780506|Secondary|Change From Baseline in CD4+ Cell Count at Week 96||Baseline; Week 96|Participants in the Full Analysis Set with on-treatment data were analyzed.||cells/µL||Standard Deviation|Mean
664888|NCT01780506|Secondary|Change From Baseline in CD4+ Cell Count at Week 48||Baseline; Week 48|Participants in the Full Analysis Set with on-treatment data were analyzed.||cells/µL||Standard Deviation|Mean
664889|NCT01780506|Secondary|Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Weeks 48 and 96|The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Weeks 48 and 96 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Weeks 48 and 96|Full Analysis Set||percentage of participants|||Number
664890|NCT01780506|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 96|Full Analysis Set||percentage of participants|||Number
664891|NCT01780506|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Full Analysis Set: participants who were randomized and received at least 1 dose of study drug.||percentage of participants|||Number
664892|NCT01780389|Secondary|Change in Total Score of Short Form-36 (SF-36), Measuring Perceived Quality of Life|"Subjective measure of perceived quality of life.The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.
The eight sections are:
vitality,
physical functioning,
bodily pain,
general health perceptions,
physical role functioning,
emotional role functioning,
social role functioning,
mental health
Scale:
0= lowest quality of life 100= high quality of life Higher scores reflect higher quality of life. Total mean cumulative scores were reported."|baseline and endpoint (12 weeks or early termination)|||units on a scale||Standard Deviation|Mean
664893|NCT01780389|Secondary|Change in Total Score of State Trait Anxiety Inventory (STAI)|"Assessment of subjective symptoms of current anxiety and chronic anxiety. There are 20 items for assessing trait anxiety and 20 for state anxiety. State anxiety items include: “I am tense; I am worried” and “I feel calm; I feel secure.” Trait anxiety items include: “I worry too much over something that really doesn’t matter” and “I am content; I am a steady person.” All items are rated on a 4-point scale (e.g., from “Almost Never” to “Almost Always”). Higher scores indicate greater anxiety.
Lowest total score is 40 (absent anxiety) Highest total score is 160 (maximum anxiety) Total mean cumulative scores were reported."|baseline and endpoint (12 weeks or early termination)|||units on a scale||Standard Deviation|Mean
664894|NCT01780389|Secondary|Change in the Montgomery Asberg Depression Rating Scale|"Staff-rated assessment of depressive symptoms. Scale is as follows:
0 to 6 – normal /symptom absent 7 to 19 – mild depression 20 to 34 – moderate depression >34 – severe depression"|Between baseline and endpoint (12 weeks or early termination)|||units on a scale||Standard Deviation|Mean
664895|NCT01780389|Secondary|Change in the Beck Depression Inventory (BDI-II)|"The secondary outcome measure is change in Beck Depression Inventory. The scale for this inventory is:
0–9: indicates minimal depression 10–18: indicates mild depression 19–29: indicates moderate depression 30–63: indicates severe depression. The higher the score the degree of depression."|Baseline to endpoint (12 weeks or early termination)|||units on a scale||Standard Deviation|Mean
664896|NCT01780389|Secondary|Change in Total Score of Multidimensional Fatigue Inventory (MFI-20)|"Measures subjective fatigue.20-item self-report instrument consisting of five scales: General Fatigue, Physical Fatigue, Reduced Activity, Reduced Motivation, and Mental Fatigue.
Each scale contains four items rated on a scale of one to 5 with the scale score of one having the anchor of entirely true and the scale score of 5 having the anchor of no, not true. The five scales were identified through factor analysis and are assumed to measure different aspects of fatigue. Lowest possible total score = 20 (absent fatigue) Highest possible total score = 100 (maximum fatigue) Total mean cumulative scores were reported"|Baseline to endpoint (12 weeks or early termination)|||units on a scale||Standard Deviation|Mean
664897|NCT01780389|Secondary|Global Rating of Change||Endpoint (12 weeks or early termination)|Data not collected.|||||
664898|NCT01780389|Secondary|Change in Knee Society Score (KSS).|"KSS measures subjective pain and objective function by joint physical exam. This secondary outcome was the change in Knee Society Score(KSS)from baseline through 12 weeks.
KSS scores measured on a scale of 0 to 100 mm:
0 = absence of pain or no pain noted 100= worst imaginable pain/as bad as can be The higher the score the greater the over all pain intensity."|between baseline and endpoint (12 weeks or early termination)|||units on a scale||Standard Deviation|Mean
664899|NCT01780389|Primary|Change in Pain Visual Analogue Scale(VAS).|"The primary outcome is change in pain VAS from baseline to 12 weeks (baseline score minus 12 week or endpoint score; positive number reflects reduction in pain score). The effect size was calculated using the VAS scores measured on a scale of 0 to 100 mm:
0= absence of pain or no pain noted 100 = worst imaginable pain/as bad as can be The higher the score the greater the over all pain intensity."|baseline and endpoint 12 weeks|||units on a scale||Standard Deviation|Mean
664900|NCT01780350|Secondary|Tolerability|Determine patient tolerability of the device while breathing through it. This is subjectively measured by the paramedic administering the device based on verbal reporting from the patient and paramedic estimation of the patient response to the device.|Duration of device use, up to 1 hour|||participants|||Number
664901|NCT01780350|Primary|Change in Systolic Blood Pressure From Baseline (Before ITD Use)|Determining whether the application of an ITD will provide improvement in systolic blood pressure in subjects with hypotension in patients being treated by San Antonio EMS when compared to baseline.|During device use, up to 1 hour|||mmHg||Standard Deviation|Mean
664902|NCT01780337|Primary|Change in Electrophysiology Measure of Right Ventricular Refractory Period|First measured at time zero, then at 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, the investigators will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'pre- ablation' period normally takes 45 minutes to one hour.|Baseline and 30 min|Only 4 out of 6 were evaluable for the Oxytocin group.||milliseconds||Standard Deviation|Mean
664903|NCT01780337|Primary|Change in Electrophysiology Measure of HV Interval|First measured at time zero, then at 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, the investigators will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'pre- ablation' period normally takes 45 minutes to one hour.|Baseline and 30 min|Only 4 out of 6 were evaluable for the Oxytocin group. Only 5 out of 6 were evaluable for the Saline group.||milliseconds||Standard Deviation|Mean
664922|NCT01779167|Secondary|Response Duration of Subjects Treated With THRiL for WM|Measure response duration of patients enrolled on THRiL for WM|24 months||||||
664923|NCT01779167|Secondary|Time to Response|Measure the time from initiating therapy to demonstrating response in WM.|approximately 24 months||||||
664904|NCT01780337|Primary|Change in Electrophysiology Measure of AH Interval|First measured at time zero, then at 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, the investigators will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'pre- ablation' period normally takes 45 minutes to one hour.|Baseline and 30 min|Only 3 out of 6 were evaluable for the Oxytocin group. Only 2 out of 6 were evaluable for the Saline group.||milliseconds||Standard Deviation|Mean
664905|NCT01780324|Primary|Pain Score on the Face, Legs, Arms, Cry, Consolability (FLACC) Scale|Pain of urethral catheterization will be determined in the lidocaine and no lidocaine groups. Score range for the FLACC scale was between 0-10 where higher score is more pain.|At time of procedure (up to 30 seconds after catheter insertion)|||units on a scale||95% Confidence Interval|Median
664906|NCT01779648|Secondary|Cycling Rate|Number of cuff inflation-deflation cycle during an hour. In group SF, the cycling rate is fixed as 90 cycles/hour, but in group AA, it is variable according to the individual venous refill time.|on 4th postoperative day after total knee replacement arthroplasty|||cycles/hour|Participants|Standard Deviation|Mean
664907|NCT01779648|Secondary|Augmented TVF|Enhanced total volume flow by application of pneumatic compression|on 4th postoperative day after total knee replacement arthroplasty|||mL/min|Participants|Standard Deviation|Mean
664908|NCT01779648|Secondary|Augmented PVF|Enhanced peak volume flow by application of pneumatic compression|On 4th postoperative days after total knee replacement arthroplasty|||mL/min|Participants|Standard Deviation|Mean
664909|NCT01779648|Secondary|Augmented MV|Enhanced mean velocity by application of pneumatic compression|On 4th postoperative days after total knee replacement arthroplasty|||cm/sec|Participants|Standard Deviation|Mean
664910|NCT01779648|Secondary|Augmented PV|Enhanced peak velocity by application of intermittent pneumatic compression|On 4th postoperative days after total knee replacement arthroplasty|||cm/sec|Participants|Standard Deviation|Mean
664911|NCT01779648|Secondary|Expelled Peak Volume|Expelled volume was theoretically calculated value in order to figure out how much blood was squeezed by the compression for an hour; expelled peak volume (EPV) = single cycle augmented PVF x cycling rate (cycles/hour).|On 4th postoperative days after total knee replacement arthroplasty|||mL/hour|Participants|Standard Deviation|Mean
664912|NCT01779648|Secondary|Expelled Total Volume|Expelled volume was theoretically calculated value in order to figure out how much blood was squeezed by the compression for an hour; expelled total volume (ETV) = single cycle augmented TVF x cycling rate (cycles/hour).|On 4th postoperative days after total knee replacement arthroplasty|||mL/hour|Participants|Standard Deviation|Mean
664913|NCT01779648|Secondary|Total Volume Flow|Doppler ultrasonography were performed to measure one of the venous hemodynamic parameters to be compared. A longitudinal scans of bilateral superficial femoral veins, just distal to the confluence of the profunda femoral veins, were performed. Baseline velocity, flow pattern, and augmented flow of 11 seconds (Simultaneous compression arm) or 12 seconds (Alternate compression arm) were recorded. Total volume flow (TVF) was automatically calculated by the software.|On 4th postoperative days after total knee replacement arthroplasty|||mL/min||Standard Deviation|Mean
664914|NCT01779648|Secondary|Peak Volume Flow|Doppler ultrasonography were performed to measure one of the venous hemodynamic parameters to be compared. A longitudinal scans of bilateral superficial femoral veins, just distal to the confluence of the profunda femoral veins, were performed. Baseline velocity, flow pattern, and augmented flow of 11 seconds (Simultaneous compression arm) or 12 seconds (Alternate compression arm) were recorded. Peak volume flow (PVF) was automatically calculated with 1-second interval around the PV.|On 4th postoperative days after total knee replacement arthroplasty|||mL/min||Standard Deviation|Mean
664915|NCT01779648|Secondary|Mean Velocity|Doppler ultrasonography were performed to measure one of the venous hemodynamic parameters to be compared. A longitudinal scans of bilateral superficial femoral veins, just distal to the confluence of the profunda femoral veins, were performed. Baseline velocity, flow pattern, and augmented flow of 11 seconds (Alternate compression arm) or 12 seconds (Simultaneous compression arm) were recorded. This is an automatically measured mean value of venous flow.|On 4th postoperative days after total knee replacement arthroplasty|||cm/sec||Standard Deviation|Mean
664916|NCT01779648|Secondary|Peak Velocity|Doppler ultrasonography were performed to measure one of the venous hemodynamic parameters to be compared. A longitudinal scans of bilateral superficial femoral veins, just distal to the confluence of the profunda femoral veins, were performed. Baseline velocity, flow pattern, and augmented flow of 11 seconds (Simultaneous compression arm) or 12 seconds (Alternate compression arm) were recorded. Under fixed state of other ultrasound scan parameters, peak velocity (PV) was measured by determination of maximum point of the augmented waveform.|On 4th postoperative days after total knee replacement arthroplasty|||cm/sec||Standard Deviation|Mean
664917|NCT01779648|Primary|Rate of Deep Vein Thrombosis|Computed tomographic angiography were performed on 4th postoperative days to detect deep vein thrombosis and evaluate its extent and location.|On 4th postoperative days after total knee replacement arthroplasty|One participant of Group SF dropped out of the analysis due to the device error; air leakage in the closed circuit system.||participants|||Number
664918|NCT01779219|Secondary|Time|the preparation (Tprep), operation (Top) and total operating room (TOR) time|From moment of the transfer to the OR until the moment of transfer out of it, assessed on the day of operation.|||minutes||Standard Deviation|Mean
664919|NCT01779219|Secondary|Length of Hospital Stay|The preoperative (LOSpre), postoperative (LOSpost) and total length of hospital stay (LOS)|From date of hospitalization until the date of discharge, assessed up to 2 days.|||days||Full Range|Median
664920|NCT01779219|Primary|Diagnostic Yield|The diagnostic yield is expressed as the number of patients in whom the histopathological diagnosis was made based of the biological material obtained during the operation.|For each patient 2 weeks after the operation|||participants|||Number
664921|NCT01779219|Primary|Number of Participants Presenting With Complications|The presence of acute postoperative complication is noted if any of following findings is present: wound site infection up to two weeks after the operation, a new neurological deficit developed up to 24 hours following the operation and present in a follow up clinical examination 2 weeks postoperatively, intraparenchymal hematoma with radiological or clinical signs of the intracranial expansion.|Patients were followed for the duration of hospital stay (average 2 days) and again 2 weeks after the operation.|Complications assessed: Haematoma, Neurological deterioration, Infection||participants|||Number
664926|NCT01779167|Secondary|Number of Adverse Events Experienced With Alternating Thalidomide and Lenalidomide Plus Rituximab for Subjects With Previously Treated Waldenstrom's Macroglobulinemia|Capture the number of adverse events experienced when combining thalidomide, lenalidomide, and rituximab in patients with previously treated WM|approximately 24 months per patient|Data were not collected|||||
664927|NCT01779167|Primary|Number of Patients Who Demonstrate a Response (Complete, Partial, Minor) to Treatment|"Response criteria for subjects with WM is based upon the Consensus Panel Recommendations from the Third International Workshop on Waldenstrom Macroglobulinemia.
Overall response rate (CR + PR + MR) measured at time of best response."|Approximately 24 months|||participants|||Number
664928|NCT01778985|Secondary|Estimated Blood Loss|Intraoperative estimated blood loss|Time of surgery, i.e. after 6-8 weeks of intervention|In both study arms, 13 participants did undergo surgery and, therefore, had an estimated blood loss value available for analysis. However, one patient each from both study arms did not have biopsies taken (technical considerations/ intraoperative decision or conversion from total to supracervical hysterectomy without ability to collect biopsy).||mL||Standard Deviation|Mean
664929|NCT01778985|Primary|Vaginal Wall Degradative Activity, Mucosa, MMP-9|Will assess zymograms for total matrix metalloprotease (MMP) 9 activity|Time of surgery, i.e. after 6-8 weeks of intervention|All specimens with sufficient amount of tissue available for zymography analysis were used.||Relative Units/mg protein||Standard Error|Mean
664930|NCT01778985|Primary|TGFB1 (Per-Protocol)|Data represent ratio of total mRNA relative to postmenopausal external control.|Time of surgery, i.e. after 6-8 weeks of intervention|||ratio||Standard Error|Mean
664931|NCT01778985|Primary|Tropoelastin (Per-Protocol)|Data represent ratio of total mRNA relative to postmenopausal external control.|Time of surgery, i.e. after 6-8 weeks of intervention|||ratio||Standard Error|Mean
664932|NCT01778985|Primary|LOXL1 (Per-Protocol)|Data represent ratio of total mRNA relative to postmenopausal external control.|Time of surgery, i.e. after 6-8 weeks of intervention|||ratio||Standard Error|Mean
664933|NCT01778985|Primary|Lysyl Oxidase (LOX) (Per-Protocol)|Data represent ratio of total mRNA relative to postmenopausal external control.|Time of surgery, i.e. after 6-8 weeks of intervention|||ratio||Standard Error|Mean
664934|NCT01778985|Primary|hCOL3, (Per-Protocol)|Data represent ratio of total mRNA relative to postmenopausal external control.|Time of surgery, i.e. after 6-8 weeks of intervention|||ratio||Inter-Quartile Range|Median
664935|NCT01778985|Primary|Vaginal Wall Composition: Lamina Propria (Per-Protocol)|Will assess vaginal wall histology - thickness of lamina propria|Time of surgery, i.e. 6-8 weeks of intervention|||microns||Standard Error|Mean
664936|NCT01778985|Primary|Vaginal Wall Composition: Lamina Propria (Intention to Treat)|Will assess vaginal wall histology - thickness of lamina propria.|Time of surgery, i.e. after 6-8 weeks of intervention|||microns||Standard Error|Mean
664937|NCT01778985|Secondary|Serum Estradiol Levels, Surgery||Time of surgery|||pg/mL||Standard Error|Mean
664938|NCT01778985|Secondary|Serum Estradiol Levels, Baseline||Baseline|||pg/mL||Standard Error|Mean
664939|NCT01778985|Secondary|Serum Estrone Levels, Surgery||Time of surgery|||pg/mL||Standard Error|Mean
664940|NCT01778985|Primary|Vaginal Wall Degradative Activity, Muscularis, MMP-9|Will assess zymograms for total matrix metalloprotease (MMP) 9 activity|Time of surgery, i.e. after 6-8 weeks of intervention|All specimens with sufficient amount of tissue available for zymography analysis were used.||Relative Units/mg protein||Standard Error|Mean
664941|NCT01778985|Primary|Total Collagen Content in Vaginal Muscularis, (Per-Protocol)|Will assess hydroxy-proline assays as index of amount of collagen|Time of surgery, i.e. after 6-8 weeks of intervention|"Patients completing surgery with biopsy specimens available for analysis and who were adherent to study medication (per protocol)"||mg collagen per mg muscularis wet weight||Standard Error|Mean
664942|NCT01778985|Secondary|Serum Estrone Levels, Baseline||Baseline|||pg/mL||Standard Error|Mean
664943|NCT01778985|Primary|hCOL1A1, Per-Protocol|Data represent ratio of total mRNA relative to postmenopausal external control.|Time of surgery, i.e. after 6-8 weeks of intervention|"Patients completing surgery with biopsy specimens available for analysis and who were adherent to study medication (per protocol)"||ratio||Inter-Quartile Range|Median
664944|NCT01778985|Primary|Vaginal Wall Composition: Muscularis (Per-Protocol)|Will assess vaginal wall histology - thicknesses of muscularis|Time of surgery, i.e. after 6-8 weeks of intervention|"Patients completing surgery with biopsy specimens available for analysis and who were adherent to study medication (per protocol)"||microns||Standard Error|Mean
664945|NCT01778985|Primary|Vaginal Wall Composition: Muscularis (Intention to Treat)|Will assess vaginal wall histology - thicknesses of muscularis|Time of surgery, i.e. after 6-8 weeks of intervention|"Patients completing surgery with biopsy specimens available for analysis (intention to treat)"||microns||Standard Error|Mean
664946|NCT01778985|Primary|Vaginal Wall Composition: Epithelium (Per-Protocol)|Will assess vaginal wall histology - thicknesses of epithelium|Time of surgery, i.e. after 6-8 weeks of intervention|"Patients completing surgery with biopsy specimens available for analysis and who were adherent to study medication (per protocol)"||microns||Standard Error|Mean
664947|NCT01778985|Primary|Vaginal Wall Composition: Epithelium (Intention to Treat)|Will assess vaginal wall histology - thicknesses of epithelium|Time of surgery, i.e. after 6-8 weeks of intervention|"Patients completing surgery with biopsy specimens available for analysis (intention to treat)"||microns||Standard Error|Mean
664948|NCT01778855|Primary|Number of Participants With Recanalization|"To determine whether hypothermia alters recanalization with standard thrombolytic treatment with intravenous (IV) tissue plasminogen activator (tPA) for acute ischemic stroke in humans. The hypothesis is that hypothermia does not impair recanalization (opening of the artery). Recanalization will be measured with Thrombolysis in Myocardial Infarction (TIMI) score change from baseline angiography to 36 hour angiography. TIMI is cored per published definition.
Additional data for secondary analyses were not acquired to permit analyses."|36 hours|Recanalization at 36 hours||Participants|||Count of Participants
664949|NCT01778751|Secondary|Depressive Symptoms|Change in Patient Health Questionnaire as measured at Baseline, 3 months, 6 months|Baseline, 3m, 6m|||units on a scale||Standard Deviation|Mean
664950|NCT01778751|Secondary|Self-reported Medication Adherence|Change in Self-Reported Medication- Taking Scale as measured at baseline, 3 months, 6 months|Baseline, 3m, 6m|||participants|||Number
664951|NCT01778751|Secondary|Diabetes Self Care|Self-Care Inventory-revised as measured at baseline, 3 months, 6 months|Baseline, 3m, 6m|||units on a scale||Standard Deviation|Mean
664954|NCT01778530|Primary|Radiographic Response Rate for Patients With Recurrent Glioblastoma Multiforme (GBM) Treated With TRC105.|Response and progression will be evaluated by the Updated Response Assessment Criteria for High-Grade Gliomas developed by the Response Assessment in Neuro-Oncology Working Group (RANO). Complete response is complete disappearance of all enhancing measurable and non-measurable disease sustained for at least 4 weeks. Partial response is >/=50% decrease compared with baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions sustained for at least 4 weeks. Stable disease does not qualify for complete response, partial response, or progression. Progression is a >/=25% increase in sum of the products of perpendicular diameters of enhancing lesions compared with the smallest tumor measurement obtained at baseline (if no decrease) or best response, on stable or increasing doses of corticosteroids,|14 months|This outcome measure was not met due to termination of the study for poor accrual.|||||
664955|NCT01778296|Secondary|Cold Intolerance|We access the cold intolerance of the injured and donor fingers using the self-administered Cold Intolerance Severity Score questionnaire10 that is rated into mild, moderate, severe, and extreme (0-25, 26-50, 51-75 and 76-100).|18 months to 24 months||||||
664956|NCT01778296|Primary|Discriminatory Sensation of the Flap|Discriminatory sensation of the flap is evaluated with the Static 2-point Discrimination Test. The test determines the minimal distance at which a subject can sense the presence of two needles. The modified American Society for Surgery of the Hand guidelines were used to stratify Discriminator measurements (excellent <6 mm; good 6-10 mm; fair 11-15 mm; poor >15 mm. The test point is at the center of the flap. Each area was tested 3 times with a Discriminator (Ali Med, Dedham, MA). Two out of 3 correct answers were considered proof of perception before proceeding to another lower value. We stop at 4mm as a limit of 2PD and considered this normal. These assessments take place at a single time point at the final follow-up.|18 months to 24 months|||mm||Standard Deviation|Mean
664957|NCT01778127|Secondary|Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Dorsiflexion at 60 Degrees/Second|The differences from baseline to 24-weeks in mean changes in ankle dorsiflexion strength at 60 degrees per second (Newton meters) was compared between groups.|Baseline and 24 weeks|||Nm/kg||Standard Deviation|Mean
664958|NCT01778127|Secondary|Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Dorsiflexion at 30 Degrees/Second|The differences from baseline to 24-weeks in mean changes in ankle dorsiflexion strength 30 degrees per second (Newton meters) was compared between groups.|Baseline and 24 weeks|||Nm/kg||Standard Deviation|Mean
664959|NCT01778127|Secondary|Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Quadriceps at 180 Degrees/Second|The difference from baseline to 24-weeks in mean changes in knee extension strength at 180 degrees per second (Newton meters) was compared between groups|Baseline and 24 weeks|||Nm/kg||Standard Deviation|Mean
664960|NCT01778127|Secondary|Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Quadriceps at 120 Degrees/Second|The difference from baseline to 24-weeks in mean changes in knee extension strength 120 degrees per second (Newton meters) was compared between groups.|Baseline and 24 weeks|||Nm/kg||Standard Deviation|Mean
664961|NCT01778127|Secondary|Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Quadriceps at 60 Degrees/Second|The difference from baseline to 24-weeks in mean changes in knee extension strength 60 degrees per second (Newton meters) was compared between groups.|Baseline and 24 weeks|||Newton meters (Nm)/kg||Standard Deviation|Mean
664962|NCT01778127|Secondary|Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Pushup|The number of push-ups completed in 30 seconds was assessed, and the differences from baseline to 24-weeks in mean changes on the strength subtests of the Bruininks-Oseretsky Test of Motor Proficiency were compared between groups.|Baseline and 24 weeks|||Pushups||Standard Deviation|Mean
664963|NCT01778127|Secondary|Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Sit-up|The number of sit-ups completed in 30 seconds was assessed, and the differences from baseline to 24-weeks in mean changes on the strength subtests of the Bruininks-Oseretsky Test of Motor Proficiency were compared between groups.|Baseline and 24 weeks|||Sit-ups||Standard Deviation|Mean
664964|NCT01778127|Secondary|Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Hand Grip|The difference from baseline to 24-weeks in mean changes in grip strength (kilograms) was compared between groups.|Baseline and 24 weeks|||kg||Standard Deviation|Mean
664965|NCT01778127|Secondary|Differences in Change in Flexibility Between Groups Over 24 Weeks: Active Dorsiflexion|The difference between mean changes from baseline to 24-weeks in active dorsiflexion was compared between groups.|Baseline and 24 weeks|||degrees||Standard Deviation|Mean
664966|NCT01778127|Secondary|Differences in Change in Flexibility Between Groups Over 24 Weeks: Sit and Reach|The difference in mean changes of sit and reach from baseline to 24-weeks was compared between groups|Baseline and 24 weeks|||cm||Standard Deviation|Mean
664967|NCT01778127|Secondary|Differences in Change in Cardiovascular Function Between Groups Over 24 Weeks|The difference in mean change in peak oxygen uptake from baseline to 24-weeks was compared between groups.|Baseline and 24 weeks|||ml/kg/min||Standard Deviation|Mean
664968|NCT01778127|Primary|Differences in Change in Daily Average of Moderate and Vigorous Physical Activity (MVPA) Levels Between Groups|The impact of the intervention was assessed at the end of 24 weeks by comparing the mean difference in physical activity levels from baseline to 24-weeks between groups.|Baseline, Week 24|||minutes||Standard Deviation|Mean
664969|NCT01778062|Secondary|Incidence of COPD Exacerbation|Number of COPD exacerbation during 8-week treatment. COPD exacerbations are defined as a new onset or worsening of at least one respiratory symptom (i.e. dyspnea, cough, sputum purulence or volume, or wheeze) present for at least 3 consecutive days, documented change or increase in COPD-related treatment due to worsening symptoms or documented COPD-related hospitalizations or emergency room visits.|8 week|ITT (intent to treat) population included data obtained from all the subjects who were enrolled in the study and received at least one dose of the investigational drug and had primary efficacy endpoint after administration of the investigational drug||Participants|||Number
664981|NCT01778023|Primary|Height Velocity (Ht-V)|Height velocity (Ht-V) (cm/year) is the change in height per year (after 6 months of treatment). Ht-V was calculated by Novo Nordisk.|After 6 months of treatment|Full analysis set (FAS) – included all randomised subjects in Group A who received at least one dose of the trial product and all randomised subjects in Group B. Four (4) subjects had missing height at baseline visit.||cm/year||Standard Error|Least Squares Mean
664970|NCT01778062|Secondary|Change From Baseline in Transition Dyspnea Index (TDI) After 8 Weeks of Treatment|TDI focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort. Each domain is scored from -3 (major deterioration) to 3 (major improvement) to give an overall TDI focal score of -9 to 9 with a negative score indicating a deterioration from baseline. A 1 unit difference in the TDI focal score is clinically significant. Mixed model used baseline dyspnoea index, FEV1 prior to and 10-15 minutes post inhalation of albuterol, and FEV1 prior to 1 hour post inhalation of ipratropium as covariates.|8 week|ITT (intent to treat) population included data obtained from all the subjects who were enrolled in the study and received at least one dose of the investigational drug and had primary efficacy endpoint after administration of the investigational drug.||Score on a scale||Standard Deviation|Mean
664971|NCT01778062|Secondary|St. George Respiratory Questionnaire for COPD (SGRQ-C) Change After 8 Weeks of Treatment|The SGRQ-C contains 14 questions divided into two components. Part 1 produces “Symptoms” scores and Part 2 “Activity” and “Impacts” scores. 14 questions which are divided in three domains: “symptom” (question 1-7), “activity” (question 9, 12) and “impact” (question 8, 10, 11, 13 and 14). The total score is 0 to 100 with a higher score indicating greater impairment of health status. Mixed model used baseline SGRQ, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.|8 week|ITT (intent to treat) population included data obtained from all the subjects who were enrolled in the study and received at least one dose of the investigational drug and had primary efficacy endpoint after administration of the investigational drug.||Score on a scale||Standard Deviation|Mean
664972|NCT01778062|Primary|Trough Forced Expiratory Volume in One Second Change|Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 hour 10 minute and 23 hour 45 minute post-dose FEV1 readings. Mixed model used baseline FEV1, FEV1 prior to and 10-15 minutes post inhalation of albuterol, and FEV1 prior to and 1 hour post inhalation of ipratropium as covariate|8 week|ITT (intent to treat) population included data obtained from all the subjects who were enrolled in the study and received at least one dose of the investigational drug and had primary efficacy endpoint after administration of the investigational drug.||Liters||Standard Deviation|Mean
664973|NCT01778049|Secondary|Fasting Plasma Glucose (FPG) Change From Baseline at 24 Weeks.|Change from baseline FPG (mmol/L) after 24 weeks of treatment with double-blind trial medication, i.e. FPG change from baseline at Week 24.|Baseline and 24 weeks|FAS (OC)||mmol/L||Standard Error|Least Squares Mean
664974|NCT01778049|Primary|Change From Baseline of HbA1c After 24 Weeks of Treatment.|"Change from baseline in Glycated haemoglobin (HbA1c) [%] after 24 weeks of treatment with double-blind trial medication, i.e. HbA1c change from baseline at Week 24. The term “baseline” was not used to refer to measurements prior to the administration of open-label medication. Such measurements were referred to as “pre-treatment. Analyses of change from pre-treatment used the last value before first administration of open-label medication as point of reference.
Observed Case (OC): This method analyse only available data that were observed while patients were on treatment, i.e., excluding the missing data. All values measured after rescue medication taken were set to missing. Full Analysis Set (FAS): Includes all patients in the Treated set who had a baseline HbA1c assessment and at least 1 on-treatment HbA1c assessment during the double-blind part of the trial."|Baseline and 24 weeks|FAS (OC)||Percentage of HbA1c||Standard Error|Least Squares Mean
664975|NCT01778023|Secondary|Ht-V (Height Velocity)|Height velocity (Ht-V) (cm/year) is the change in height per year (after 6 months of treatment). Three sort of Ht-V was calculated from height data at Visit 2 (day 0), 4 (6 months ± 7 days) and 6 (12 months ± 7 days), as follows: Between Visits 2 and 4, between Visit 4 and 6 and between Visit 2 and 6. Ht-V was calculated by Novo Nordisk. It is the difference between Ht-V for the last 6 months and Ht-V for the first 6 months of treatment. This endpoint was only evaluated for Group A as per the trial protocol.|At the first 6 months and the last 6 months in group A|Full analysis set (FAS) – included all randomised subjects in Group A who received at least one dose of the trial product and all randomised subjects in Group B.||cm/year||95% Confidence Interval|Least Squares Mean
664976|NCT01778023|Secondary|Occurrence of Adverse Events|AEs were collected throughout the trial in both groups.|Throughout the trial (12 months)|Safety analysis set – includes all subjects in Group A receiving at least one dose of the trial product and all subjects in Group B who had any available data after Visit 2.||events|||Number
664977|NCT01778023|Secondary|Change in Bone Age|Change in bone age from the baseline to 6 months.|After 6 months of treatment.|Safety analysis set (SAS) :includes all subjects in Group A receiving at least one dose of the trial product and all subjects in Group B who had any available data after Visit 2.||years||Standard Deviation|Mean
664978|NCT01778023|Secondary|Change in IGF Related Factors: IGFBP-3 (Insulin-like Growth Factor Binding Protein-3)|IGFBP-3 was measured at Visit 1(screening), Visit 3 (3 months ± 7 days ), Visit 4 (6 months ± 7 days), 5 (9 months ± 7 days ) and 6 ( 12 months ± 7 days). Change of IGFBP-3 from baseline to 6 months treatment were calculated.|After 6 months of treatment.|Full analysis set (FAS) – included all randomised subjects in Group A who received at least one dose of the trial product and all randomised subjects in Group B.||mcg/mL||Standard Error|Least Squares Mean
664979|NCT01778023|Secondary|Change in IGF Related Factors: IGF-I (Insulin-like Growth Factor-I)|IGF-I (insulin-like growth factor-1) was measured at Visit 1 (screening),Visit 3 (3 months ± 7 days ),Visit 4 (6 months ± 7 days),Visit 5 (9 months ± 7 days ) and Visit 6 (12 months ± 7 days ). Change of IGF-I from baseline to 6 months treatment was calculated.|After 6 months of treatment.|Full analysis set (FAS) – included all randomised subjects in Group A who received at least one dose of the trial product and all randomised subjects in Group B.||ng/ml||Standard Error|Least Squares Mean
664980|NCT01778023|Secondary|Change in Ht-SDS (Height Standard Deviation Score)|Height standard deviation scores (HSDS) were calculated using Korean growth data (reported by the Korea Centre for Disease Control and Prevention). The mean normal range for HSDS is from -2 to +2. Negative scores below -2 indicate a height below normal range, whereas positive scores above +2 indicate a height above normal.|After 6 months of treatment.|Full analysis set (FAS) – included all randomised subjects in Group A who received at least one dose of the trial product and all randomised subjects in Group B. Four (4) subjects had missing height at baseline visit.||Standard Deviation Score (SDS)||Standard Error|Least Squares Mean
666045|NCT01763905|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
664986|NCT01777945|Secondary|Overall Response Rate|The percentage of participants with complete or partial remission, based on evaluation of tumor responses assessed at regular examinations per routine clinical practice.|approximately 2 years|||percentage of participants|||Number
664987|NCT01777945|Secondary|Time to Treatment Failure|The time from enrollment to discontinuation of any drug of the treatment combination.|approximately 2 years|||months||Standard Deviation|Mean
664988|NCT01777945|Primary|Progression-free Survival (PFS)|The time from enrollment until disease progression, assessed as the time to tumor progression, as evaluated by regular examinations per routine clinical practice, or death from any cause.|approximately 2 years|||months||Standard Deviation|Median
664989|NCT01777932|Secondary|Participants With Proteinuria at Study Entry (Baseline)|The number of participants with proteinurea status as positive, negative or missing is reported.|Baseline (Day 1)|All enrolled participants were considered for this outcome measure||participants|||Number
664990|NCT01777932|Secondary|Participants With Type of Metastases at Study Entry (Baseline)|The type of metastases (bone and visceral) are reported at study entry (baseline) is reported.|Baseline (Day 1)|All enrolled participants were considered for this outcome measure.||participants|||Number
664991|NCT01777932|Secondary|Participants With Disease History at Study Entry (Baseline)|Participant’s history at the time of diagnosis of metastatic disease and sites of metastases is reported at study entry (baseline).|Baseline (Day 1)|All enrolled participants were considered for this outcome measure.||participants|||Number
664992|NCT01777932|Secondary|Participants With Prior Therapy at Study Entry (Baseline)|The status of prior therapy (i.e. chemotherapy, endocrine therapy, and radiotherapy) at study entry (baseline) is reported.|Baseline (Day 1)|All enrolled participants were considered for this outcome measure||participants|||Number
664993|NCT01777932|Secondary|Participants With Eastern Cooperative Oncology Group Status at Study Entry|The Eastern Cooperative Oncology Group (ECOG) status for participants was categorized as 0, 1, 2, or missing. ECOG has 4 grades as: 0 = Fully active, able to carry out all pre-disease activities; 1 = Restricted in strenuous activity but ambulatory and able to carry out work of light or sedentary nature; 2 = Ambulatory and capable of all self-care but unable to carry out work activities. Active about 50% of waking hours; 3 = Capable of limited self-care, confined to bed/chair more than 50% of waking hours; 4 = Completely disabled; cannot carry on self-care, totally confined to bed/chair.|Baseline (Day 1)|All enrolled participants were considered for this outcome measure.||participants|||Number
664994|NCT01777932|Secondary|Participants With Tumor Stage at Diagnosis|Number of participants at each Metastatic breast cancer stage 0, I, II, III or IV, at the point of diagnosis is reported.|Baseline (Day 1)|All enrolled participants were considered for this outcome measure.||participants|||Number
664995|NCT01777932|Secondary|Progression Free Survival in Participants With Triple Negative Receptor Status at Study Entry|PFS was assessed based on time to tumour progression or death (whichever occurred first) from the start of bevacizumab treatment for participants with triple negative status and not triple negative status.|Approximately 5 years|All enrolled participants were considered for this outcome measure. Out of the total 220 enrolled participants, 106 participants were triple negative, 110 were not triple negative and data for 4 participants were missing.||months||95% Confidence Interval|Median
664996|NCT01777932|Secondary|Participants With Hormone Receptor Status at Diagnosis|The hormone receptor status for Oestrogen (ER), Progesterone (PgR) and Human epidermal growth factor receptor (HER-2) is reported as positive, negative, unknown or missing.|Baseline (Day 1)|All enrolled participants were considered for this outcome measure.||participants|||Number
664997|NCT01777932|Secondary|Time to Discontinuation (TTD) of Bevacizumab Treatment|Time to treatment discontinuation is defined as the time to change of therapy due to any cause (tumour progression, toxicity, or other causes) from the start of bevacizumab treatment.|Approximately 5 years|All enrolled participants were considered for this outcome measure.||months||95% Confidence Interval|Median
664998|NCT01777932|Secondary|One Year Survival|The status of participants whether alive, dead, unknown or missing one year after the start of bevacizumab treatment is reported.|Approximately 5 years|All enrolled participants were considered for this outcome measure.||participants|||Number
664999|NCT01777932|Primary|Progression Free Survival|Progression free survival (PFS) was assessed based on time to tumour progression or death (whichever occurred first) from the start of bevacizumab treatment.|Approximately 5 years|All enrolled participants were considered for this outcome measure.||months||95% Confidence Interval|Median
665000|NCT01777776|Secondary|Phase Ib/II - Pharmacokinetic Parameters: Racc|Due to the halt of enrollment during the Phase Ib part of the study, all analyses related to pharmacokinetic parameters were not performed.|28-day cycles|This analysis group would have been the PK analysis set (PAS), which would have consisted of all patients who had at least one blood sample providing evaluable drug concentration data.|||||
665001|NCT01777776|Secondary|Phase Ib/II - Pharmacokinetic Parameters: Tmax|Due to the halt of enrollment during the Phase Ib part of the study, all analyses related to pharmacokinetic parameters were not performed.|28-day cycles|This analysis group would have been the PK analysis set (PAS), which would have consisted of all patients who had at least one blood sample providing evaluable drug concentration data.|||||
665002|NCT01777776|Secondary|Phase Ib/II - Pharmacokinetic Parameters: Cmax|Due to the halt of enrollment during the Phase Ib part of the study, all analyses related to pharmacokinetic parameters were not performed.|28-day cycles|This analysis group would have been the PK analysis set (PAS), which would have consisted of all patients who had at least one blood sample providing evaluable drug concentration data.|||||
665003|NCT01777776|Secondary|Phase Ib/II - Pharmacokinetic Parameters: Cmin|Due to the halt of enrollment during the Phase Ib part of the study, all analyses related to pharmacokinetic parameters were not performed.|28-day cycles|This analysis group would have been the PK analysis set (PAS), which would have consisted of all patients who had at least one blood sample providing evaluable drug concentration data.|||||
665004|NCT01777776|Secondary|Phase Ib/II - Pharmacokinetic Parameters: AUCtau|Due to the halt of enrollment during the Phase Ib part of the study, all analyses related to pharmacokinetic parameters were not performed.|28-day cycles|This analysis group would have been the PK analysis set (PAS), which would have consisted of all patients who had at least one blood sample providing evaluable drug concentration data.|||||
666046|NCT01763905|Secondary|Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
665005|NCT01777776|Secondary|Phase II - Overall Survival (OS)|"OS is defined as the time from date of randomization/start of treatment to date of death due to any cause. If a patient is not known to have died, survival will be censored at the date of last known date patient alive.
Due to the halt of enrollment during the Phase Ib part of the study, this analysis was not performed."|Approximately 23 months after enrollment|This analysis set would have been the Full Analysis (FAS), which included all patients who received at least one dose of encorafenib or ribociclib.|||||
665006|NCT01777776|Secondary|Phase Ib/II - Duration Of Response (DOR)|"DOR is calculated as the time from the date of first documented response (complete response (CR) or partial response (PR)) to the first documented date of progression or death due to underlying cancer.
Due to the halt of enrollment during the Phase Ib part of the study, this analysis was not performed."|Approximately 23 months after enrollment|This analysis set would have been the Full Analysis (FAS), which included all patients who received at least one dose of encorafenib or ribociclib.|||||
665007|NCT01777776|Secondary|Phase Ib/II - Progression Free Survival (PFS)|"PFS is the time from date of randomization/start of treatment to the date of event defined as the first documented progression or death due to any cause.
Due to the halt of enrollment during the Phase Ib part of the study, this analysis was not performed."|Approximately 23 months after enrollment|This analysis set would have been the Full Analysis (FAS), which included all patients who received at least one dose of encorafenib or ribociclib.|||||
665008|NCT01777776|Secondary|Phase Ib/II - Overall Response Rate (ORR)|"ORR is defined as the proportion of patients with a best overall response of complete response or partial response.
Due to the halt of enrollment during the Phase Ib part of the study, this analysis was not performed."|Approximately 23 months after enrollment|This analysis set would have been the Full Analysis (FAS), which included all patients who received at least one dose of encorafenib or ribociclib.|||||
665009|NCT01777776|Secondary|Phase Ib/II - Plasma Concentration-time Profiles|Due to the halt of enrollment during the Phase Ib part of the study, all analyses related to plasma concentration time profiles were not performed.|28-day cycles|This analysis group would have been the PK analysis set (PAS), which would have consisted of all patients who had at least one blood sample providing evaluable drug concentration data.|||||
665010|NCT01777776|Secondary|Phase I - Number of Subjects Experiencing at Least One Serious Adverse Event (SAE).||Approximately 23 months after enrollment|Analysis group is comprised of the Safety Set (SS), which is all patients who received at least one dose of LEE011 or LGX818, and have at least one valid post-baseline safety assessment.||participants|||Number
665011|NCT01777776|Secondary|Phase I - Number of Subjects Experiencing at Least One Adverse Event (AE).||Approximately 23 months after enrollment|Analysis group is comprised of the Safety Set (SS), which includes all patients who received at least one dose of LEE011 or LGX818, and have at least one valid post-baseline safety assessment.||participants|||Number
665012|NCT01777776|Primary|Phase II - Objective Response Rate (ORR)|"As per RECIST v1.1, ORR is defined as the proportion of patients with a best overall response of complete response or partial response.
Due to the halt of enrollment during the Phase Ib part of the study, all analyses related to efficacy were not performed."|Approximately 23 months after enrollment|This analysis set would have been the Full Analysis (FAS), which included all patients who received at least one dose of encorafenib or ribociclib.|||||
665013|NCT01777776|Primary|Phase II - Progression Free Survival (PFS)|"As per RECIST v1.1, PFS is the time from date of randomization/ start of treatment to the date of event defined as the first documented progression or death due to any cause.
Due to the halt of enrollment during the Phase Ib part of the study, all analyses related to efficacy were not performed."|Approximately 23 months after enrollment|This analysis set would have been the Full Analysis (FAS), which included all patients who received at least one dose of encorafenib or ribociclib.|||||
665014|NCT01777776|Primary|Phase Ib - Incidence of Dose Limiting Toxicities (DLTs) in Cycle 1|"Dose Limiting Toxicities (DLTs) during the first 28 days of the combination treatment of LEE011 and LGX818.
Due to the halt of enrollment, no Maximum Tolerated Dose (MTD) was formally declared during the study."|Cycle 1 (approximately 28 days)|Analysis group is comprised of the Safety Set (SS), which includes all patients who received at least one dose of LEE011 or LGX818, and have at least one valid post-baseline safety assessment.||participants with DLTs|||Number
665015|NCT01777763|Other Pre-specified|Number of Participants Discontinuing Study Treatment Due to an AE|AEs are any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not considered related to this study drug. These AEs resulted in participants stopping study drug treatment. This measure includes participants who discontinued due to AEs and also includes treatment failures that were attributed to AEs.|Up to Day 28|The safety population consisted of all participants who received at least one dose of study drug.||Participants|||Number
665016|NCT01777763|Other Pre-specified|Number of Participants With Treatment-Related AEs|AEs are any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not considered related to this study drug. Treatment-related AEs were considered by the investigator to be related to the study drug.|Up to Day 65|The safety population consisted of all participants who received at least one dose of study drug.||Participants|||Number
665017|NCT01777763|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs)|AEs are any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not considered related to this study drug. Treatment-emergent AEs are any events not present before starting study drug treatment or any events that were present before treatment that worsened in either intensity or frequency after exposure to study drug.|Up to Day 65|The safety population consisted of all participants who received at least one dose of study drug.||Participants|||Number
665018|NCT01777763|Other Pre-specified|Number of Participants Surviving at Day 65|Number of Participants Alive at Day 65|Day 65|The safety population consisted of all participants who received at least one dose of study drug.||Participants|||Number
665019|NCT01777763|Primary|Apparent Total Body Clearance (CL/F) for Posaconazole Tablet|Blood samples for the assessment of CL/F, the rate at which posaconazole was removed from the body, were collected on Day 1 and Day 8 predose and then at specified time points up to 24 hours postdose.|Predose on Day 1 up to 24 hours postdose on Day 8|The CL/F PK population included participants who met the inclusion/exclusion criteria, complied with protocol procedures including collection of specified PK and dosing parameters, had no major protocol violations, and had documented adherence to dosing and PK regimens through predose on the Day 8 steady-state visit.||L/hr||Standard Deviation|Mean
665020|NCT01777763|Primary|Time to Maximum Concentration (Tmax) of Posaconazole Tablet|Blood samples for the assessment of Tmax were collected on Day 1 and Day 8 predose and then at specified time points up to 24 hours postdose.|Predose on Day 1 up to 24 hours postdose on Day 8|The Tmax PK population included participants who met the inclusion/exclusion criteria, complied with protocol procedures including collection of specified PK and dosing parameters, had no major protocol violations, and had documented adherence to dosing and PK regimens through the Day 8 steady-state visit.||Hours||Full Range|Median
665021|NCT01777763|Primary|Maximum Concentration (Cmax) of Posaconazole Tablet|Blood samples for the assessment of Cmax were collected on Day 1 and Day 8 predose and then at specified time points up to 24 hours postdose.|Predose on Day 1 up to 24 hours postdose on Day 8|The Cmax PK population included participants who met the inclusion/exclusion criteria, complied with protocol procedures including collection of specified PK and dosing parameters, had no major protocol violations, and had documented adherence to dosing and PK regimens through the Day 8 steady-state visit.||ng/mL||Standard Deviation|Mean
665022|NCT01777763|Primary|Minimum Concentration (Cmin) of Posaconazole Tablet|Cmin was defined as posaconazole trough level immediately before a participant received the dose of posaconazole tablets on the specified day. Trough (Cmin) level blood samples for determination of posaconazole in plasma were collected for all participants on Day 1, Day 2, Day 3, and Day 8. On Day 1, the trough level sample was collected the before the first dose of study drug. On Day 2, trough samples were collected approximately 12 hours after the second dose of study drug was administered on Day 1. On all subsequent days, trough samples were collected approximately 24 hours following the previous day's dose of study drug.|Predose on Day 1 up to 24 hours postdose on Day 8|The Cmin PK population included participants who met the inclusion/exclusion criteria, complied with protocol procedures including collection of specified PK and dosing parameters, had no major protocol violations, and had documented adherence to dosing and PK regimens through the Day 8 steady-state visit.||ng/mL||Standard Deviation|Mean
665023|NCT01777763|Primary|Average Concentration (Cavg) of Posaconazole Tablet|"Posaconazole steady-state concentrations of posaconazole in the plasma reached after regular and repeated dosing were used to estimate pharmacokinetic (PK) parameters for each participant where Cavg was defined as area under the plasma concentration versus time curve divided by the dosing interval.
Blood samples for the assessment of Cavg were collected on Day 1 and Day 8 predose and then at specified time points up to 24 hours postdose."|Predose on Day 1 up to 24 hours postdose on Day 8|The Cavg PK population included participants who met the inclusion/exclusion criteria, complied with protocol procedures including collection of specified PK and dosing parameters, had no major protocol violations, and had documented adherence to dosing and PK regimens through the Day 8 steady-state visit.||ng/mL||Standard Deviation|Mean
665024|NCT01777620|Secondary|Percentage of Participants With at Least a 1-Grade Improvement in the Investigator's Assessment of the Severity of CFL at Maximum Smile Assessed Using the FWS|The Investigator assessed the severity of the patient’s CFL at maximum smile using the 4-point FWS where: 0=none, 1=mild, 2=moderate, and 3=severe. The percentage of participants with at least a 1-Grade improvement from Baseline is reported.|Baseline, Day 30|Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.||Percentage of participants|||Number
665025|NCT01777620|Secondary|Percentage of Participants With a Score of None or Mild in the Investigator's Assessment of the Severity of Glabellar Lines at Maximum Frown Assessed Using the FWS|The Investigator assessed the severity of the patient’s glabellar lines at maximum frown using the 4-point Facial Wrinkle Scale (FWS) where: 0=none, 1=mild, 2=moderate, and 3=severe. The percentage of participants with a score of none or mild is reported.|Day 30|Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.||Percentage of participants|||Number
665026|NCT01777620|Secondary|Percentage of Participants Who Were Likely to Continue Treatment of CFL and Glabellar Lines Assessed Using the FLSQ|Participants assessed how likely they were to continue treatment of CFL and glabellar Lines using the FLSQ 5-point scale where: 1=Not at all, 2=A little bit, 3=Moderately, 4=Quite a bit and 5=Extremely. The percentage of participants with responses Moderately, Quite a bit and Extremely is reported.|Day 90|Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.||Percentage of participants|||Number
665027|NCT01777620|Secondary|Percentage of Participants Who Were Likely to Continue Treatment of Glabellar Lines Assessed Using the FLSQ|Participants assessed how likely they were to continue treatment of glabellar Lines using the FLSQ 5-point scale where: 1=Not at all, 2=A little bit, 3=Moderately, 4=Quite a bit and 5=Extremely. The percentage of participants with responses Moderately, Quite a bit and Extremely is reported.|Day 90|Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.||Percentage of participants|||Number
665028|NCT01777620|Secondary|Percentage of Participants Where Treatment of CFL and Glabellar Lines Met Expectation Assessed Using the FLSQ|Participants assessed whether treatment of glabellar lines met expectations using the FLSQ 3-point scale where: 1=Worse than expected, 2=Met expectations and 3=Better than expected. The percentage of participants with responses Met expectations and Better than expected is reported.|Day 60|Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.||Percentage of participants|||Number
665029|NCT01777620|Secondary|Percentage of Participants Satisfied With Duration of Treatment of CFL and Glabellar Lines Assessed Using the FLSQ|Participants assessed their overall satisfaction with duration of treatment of both CFL and glabellar lines using the FLSQ 5-point scale where: -2=Very dissatisfied, -1=Mostly dissatisfied, 0=Neither dissatisfied nor satisfied, 1=Mostly satisfied and 2=Very satisfied. The percentage of participants with responses mostly or very satisfied is reported.|Day 90|Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.||Percentage of participants|||Number
665054|NCT01777321|Secondary|Number of Subjects With pIMDs||Up to Month 14 post vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.||Subjects|||Number
666047|NCT01763905|Secondary|Percentage of Participants With LDL-C < 70 mg/dL (1.8 mmol/L) at Week 12||Week 12|Full analysis set||percentage of participants||95% Confidence Interval|Number
665030|NCT01777620|Secondary|Percentage of Participants Where Treatment of Glabellar Lines Met Expectation Assessed Using the FLSQ|Participants assessed whether treatment of their glabellar lines met expectation using the FLSQ 3-point scale where: 1=Worse than expected, 2=Met expectations and 3=Better than expected. The percentage of participants with responses Met expectations and Better than expected is reported.|Day 60|Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.||Percentage of participants|||Number
665031|NCT01777620|Secondary|Percentage of Participants Satisfied With Duration of Treatment of Glabellar Lines Assessed Using the FLSQ|Participants assessed their overall satisfaction with duration of treatment of glabellar lines using the FLSQ 5-point scale where: -2=Very dissatisfied, -1=Mostly dissatisfied, 0=Neither dissatisfied nor satisfied, 1=Mostly satisfied and 2=Very satisfied. The percentage of participants with responses mostly or very satisfied is reported.|Day 90|Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.||Percentage of participants|||Number
665032|NCT01777620|Secondary|Percentage of Participants Satisfied With Treatment of Crow’s Feet Lines (CFL) and Glabellar Lines Assessed Using the FLSQ|Participants assessed their overall satisfaction with both their CFL and glabellar lines using the FLSQ 5-point scale where: -2=Very dissatisfied, -1=Mostly dissatisfied, 0=Neither dissatisfied nor satisfied, 1=Mostly satisfied and 2=Very satisfied. The percentage of participants mostly or very satisfied is reported.|Day 60|Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.||Percentage of participants|||Number
665033|NCT01777620|Primary|Percentage of Participants Satisfied With Treatment of Glabellar Lines Assessed Using the Facial Line Satisfaction Questionnaire (FLSQ)|Participants assessed their overall satisfaction with their glabellar (frown) lines using the FLSQ 5-point scale where: -2=Very dissatisfied, -1=Mostly dissatisfied, 0=Neither dissatisfied nor satisfied, 1=Mostly satisfied and 2=Very satisfied. The percentage of participants with responses mostly or very satisfied is reported.|Day 60|Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.||Percentage of participants|||Number
665034|NCT01777581|Secondary|State-trait Anxiety Inventory (STAI)|"Self-report evaluation of anxiety symptoms.Assessment of subjective symptoms of current anxiety and chronic anxiety.
There are 20 items for assessing trait anxiety and 20 for state anxiety. State anxiety items include: “I am tense; I am worried” and “I feel calm; I feel secure.” Trait anxiety items include: “I worry too much over something that really doesn’t matter” and “I am content; I am a steady person.” All items are rated on a 4-point scale
Scale
1= almost never 4= almost always
Higher scores indicate greater anxiety. Mean cumulative scores were reported"|baseline and 10 weeks|||units on a scale||Standard Deviation|Mean
665035|NCT01777581|Secondary|Beck Depression Inventory (BDI-II)|"Self-report evaluation of depressive symptoms.The secondary outcome measure is change in Beck Depression Inventory. The scale for this inventory is:
0–9: indicates minimal depression 10–18: indicates mild depression 19–29: indicates moderate depression 30–63: indicates severe depression. The higher the score the degree of depression."|baseline and 10 weeks|||units on a scale||Standard Deviation|Mean
665036|NCT01777581|Secondary|Neuropathic Pain Questionnaire|"Self-report evaluation of nerve pain symptoms. A low total cumulative score means less pain and higher cumulative score is greater pain.
Total cumulative scores range form 0 to 1000 where in 0 is absence of pain and 1000 highest pain."|baseline and 10 weeks|||units on a scale||Standard Deviation|Mean
665037|NCT01777581|Secondary|Oswestry Low Back Pain Disability Questionnaire|"Self report evaluation of various back pain symptoms. For each of 10 sections participants rate pain on a scale of 0-5 in these categories:
Section 1 – Pain intensity
Section 2 – Personal care
Section 3 – Lifting
Section 4 – Walking
Section 5 – Sitting
Section 6 – Standing
Section 7 – Sleeping
Section 8 – Sex life (if applicable)
Section 9 – Social life
Section 10 – Travelling
The scores are combined form each category into overall score. Scores are converted to percentages as follows:
0% to 20%: minimal disability: The patient can cope with most living activities.
21%-40%: moderate disability: The patient experiences more pain and difficulty with sitting, lifting and standing.
41%-60%: severe disability: Pain remains the main problem-activities of daily living are affected.
61%-80%: crippled: Back pain impinges on all aspects of life.
81%-100%: Patients are either bed-bound or exaggerating their symptoms"|baseline and 10 weeks|||percent score||Standard Deviation|Mean
665038|NCT01777581|Secondary|SF-36 (Short Form)|"Self-report of quality of life. Subjective measure of perceived quality of life.The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section.
Scoring: Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. Higher scores reflect higher quality of life with 100 high life quality. Total mean cumulative scores were reported
The eight sections are:
vitality physical functioning bodily pain general health perceptions physical role functioning emotional role functioning social role functioning mental health"|baseline and 10 weeks|||units on a scale||Standard Deviation|Mean
665039|NCT01777581|Secondary|VAS Related to Nociceptive Pain Component (VAS-Noc)|The secondary outcome is change in pain VAS from baseline through 1o weeks as related to nociceptive pain component. The effect size was calculated using the VAS scores measured on a scale of 0 to 100 mm with 0 being absence of pain or no pain noted and 100 being worst imaginable pain/as bad as can be. The higher the score the greater the over all pain intensity. Mean cumulative scores were reported|baseline and 10 weeks|||units on a scale||Standard Deviation|Mean
665040|NCT01777581|Primary|Visual Analogue Scale Score Referring to Radicular Pain (VAS-rad)|The primary outcome is change in pain VAS from baseline through 10 weeks. The effect size was calculated using the VAS scores measured on a scale of 0 to 100 mm with 0 being absence of pain or no pain noted and 100 being worst imaginable pain/as bad as can be. The higher the score the greater the over all pain intensity. Mean cumulative total scores were reported.|baseline and 10 weeks|||units on a scale||Standard Deviation|Mean
665041|NCT01777438|Secondary|Percentage of Patients That Met ARIA Criteria for Mild AR Symtoms at a Mean Interval of 3 Years After Diagnosis|"ARIA classification of AR is made by duration and severity of AR symptoms. Here are calculated the number of patients having mild acute rhinitis.
Clinical practice guidelines such as the Allergic Rhinitis and its Impact on Asthma (ARIA) document focus on the quality of life as a principal consideration in assessment and treatment of AR"|3 years after diagnosis|||percentage of participants|||Number
665042|NCT01777438|Primary|Degree of Symptom Control 3 Years After IT or 3 Years After Medical Treatment With VAS of Total Nasal Symptom < 5/10 Defined as a Controlled Situation.|Visual analogue scale (VAS) scores for TNS experienced during the last 4 weeks. Visual analog scales (VAS) have been used to rate the presence of symptoms or impairment of the daily activities. Patients had to answer each question by indicating a position with a vertical line between two endpoints, 0 cm for not bothersome versus 10 cm for extremely bothersome. In this way each question is scored between 0 and 10 points.|3 years after diagnosis|||Score on a scale||Standard Deviation|Mean
665043|NCT01777438|Secondary|Percentage of Patients Having Controlled Allergic Rhinosinusitis (AR) Symptoms 3 Years After Starting Treatment|Based on the proposed cut-off value of VAS < 5/10 for total nasal symptoms (TNS), rhinitis was considered as being controlled in 69 IT patients (84%) versus 223 (63%) non-IT patients|3 years after starting SCIT|||percentage of participants|||Number
665044|NCT01777438|Primary|Current Medication Use Three Years After Diagnosis of AR|Percentage patients in both groups that still use medication for their allergic rhinitis symptoms, 3 years after starting their therapy (non IT-group vs IT-group)|3 years after starting SCIT|||percentage of participants|||Number
665045|NCT01777425|Other Pre-specified|Visual Analogue Scale (VAS), Sinonasal Outcome Test (SNOT22) and Short Form (36) Health Survey (SF36) Score Three Years After ESS in Controlled, Partially Controlled and Uncontrolled Group|"VAS scores: a measurement of patient’s subjective evaluation by indicating a position on a line between two endpoints. Patients will score eight individual symptoms on a scale from 0 until 10, being 0 no trouble and 10 maximum trouble. Finally a mean symptom score will be calculated per symptom.
The SNOT-22 questionnaire is a validated 22 item questionnaire. patients indicate how much they are affected in eight different areas and identify the 5 most important items. The SNOT-22 total score can range from 0 to 110, with higher scores representing worse quality of life.
Perceived health status can be evaluated by the 36-item short-form (SF-36). It consists of 36 items covering eight domains. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability"|three years after ESS|||units on a scale||Standard Deviation|Mean
665046|NCT01777425|Secondary|Control Nasal Endoscopy|Evaluating of difference in control if nasal endoscopy is performed three years after ESS.|3 years after ESS|fully controlled status with endoscopic evaluation||percentage of participants|||Number
665047|NCT01777425|Primary|Control Status of Patients With Rhinosinusitis|1. Percentage of patients with rhinosinusitis that are fully controlled, partly controlled and uncontrolled according to the new european position paper on rhinosinusitis (EPOS) definitions at a mean interval of 3 years after endoscopic sinus surgery.|3 years after FESS|||percentage of participants|||Number
665048|NCT01777412|Primary|Follow-Up Expanded Disability Status Score (EDSS)|"EDSS
The EDSS provides a total score on a scale that ranges from 0 to 10. The first levels 1.0 to 4.5 refer to people with a high degree of ambulatory ability and the subsequent levels 5.0 to 9.5 refer to the loss of ambulatory ability."|Follow-up visit 91 days after admission|||units on a scale||Inter-Quartile Range|Median
665049|NCT01777412|Primary|Safety Assessment and Side Effects|Frequency and severity of adverse events and side effects. Serious adverse events are considered those which are life threatening, lead to hospitalization and related to the drug. Side effects are considered minor effects of the experimental drug that do not significantly impact the care of the patient with the experimental drug.|91 days|||participants|||Number
665050|NCT01777412|Primary|Baseline Expanded Disability Status Score (EDSS)|"EDSS
The EDSS provides a total score on a scale that ranges from 0 to 10. The first levels 1.0 to 4.5 refer to people with a high degree of ambulatory ability and the subsequent levels 5.0 to 9.5 refer to the loss of ambulatory ability."|Admission to hospital|||units on a scale||Inter-Quartile Range|Median
665051|NCT01777334|Secondary|Change From Baseline (BL) in Weighted Mean (WM) 0-6 Hour FEV1 Obtained Post-dose at Day 168|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The WM FEV1 was derived by calculating the area under the FEV1/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. The WM was calculated at Days 1, 84, and 168 using the 0-6-hour post-dose FEV1 measurements collected on that day, which included pre-dose (Day 1: 30 minutes [min] and 5 min prior to dosing; other serial visits: 23 and 24 hours after the previous morning dose) and post-dose at 15 min, 30 min, 1 hour, 3 hours, and 6 hours. Change from BL at a particular visit was calculated as the WM value at that visit minus the BL value. Analysis was performed using a repeated measures model with covariates of treatment, BL (mean of the two assessments made 30 min and 5 min pre-dose on Day 1), smoking status, center group, day, and day by BL and day by treatment interactions.|Baseline and Day 168|ITT Population. Par. analyzed are those with data available at the presented time point; but, all par. without missing covariate information and with >=1 post-Baseline measurement were included in the analysis.||Liters||Standard Error|Least Squares Mean
665052|NCT01777334|Primary|Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 169 (Week 24)|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 measurements were taken electronically by spirometry on Days 2, 28, 56, 84, 112, 140, 168, and 169. Baseline is defined as the mean of the assessments made 30 minutes (min) pre-dose and 5 min pre-dose on Treatment Day 1. Trough FEV1 is defined as the mean of the FEV1 values obtained at 23 and 24 hours (hr) after the previous morning's dosing (ie., trough FEV1 on Day 169 is the mean of the FEV1 values obtained 23 and 24 hr after the morning dosing on Day 168). Change from Baseline at a particular visit was calculated as the trough FEV1 value at that visit minus the Baseline value. Analysis was performed using a repeated measures model with covariates of treatment, Baseline (mean of the two assessmentsmade 30 min and 5 min pre-dose on Day 1), smoking status, center group, day, and day by Baseline and day by treatment interactions.|Baseline and Day 169|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study drug during the Treatment Period. Par. analyzed are those with data available at the presented time point; but, all par. without missing covariate information and with >=1 post-BL measurement were included in the analysis.||Liters||Standard Error|Least Squares Mean
665053|NCT01777321|Secondary|Number of Subjects With SAEs||Up to Month 14 post vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.||Subjects|||Number
665116|NCT01776645|Other Pre-specified|Change in Compassion|As assessed by Neff's Self-Compassion Scale|Baseline and end of 9-week treatment protocol||||||
665055|NCT01777321|Secondary|Number of Subjects With Vaccine Response for Anti-gE Antibody Concentrations|Vaccine response was defined as: For initially seronegative subjects, antibody concentration at post-vaccination ≥ 4 fold the cut-off for Anti-gE (4x97 mIU/mL); for initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration.|Twelve Months after Dose 2 (M14)|The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom data concerning immunogenicity persistence outcome variables were available.||Subjects|||Number
665056|NCT01777321|Secondary|Anti-gE Antibody Concentrations||At Month 14|The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom data concerning immunogenicity persistence outcome variables were available.||mIU/mL||95% Confidence Interval|Geometric Mean
665057|NCT01777321|Secondary|Number of Subjects With Anti-gE Antibody Concentrations ≥ 97 mIU/mL||At Month 14|The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom data concerning immunogenicity persistence outcome variables were available.||Subjects|||Number
665058|NCT01777321|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Up to 30 days post vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.||Subjects|||Number
665059|NCT01777321|Primary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|Within 30 days (Days 0-29) post vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.||Subjects|||Number
665060|NCT01777321|Primary|Number of Subjects With Potential Immune-Mediated Disorders (pIMDs)||Up to 30 days post vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.||Subjects|||Number
665061|NCT01777321|Primary|Number of Days With General Symptoms||During the 7 day (Days 0-6) post vaccination, after each dose (D)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.||Days||Inter-Quartile Range|Mean
665062|NCT01777321|Primary|Number of Days With Local Symptoms||During the 7 day (Days 0-6) post vaccination, after each dose (D)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.||Days||Inter-Quartile Range|Mean
665063|NCT01777321|Primary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms were: Fatigue, Fever, Gastrointestinal (nausea, vomiting, diarrhea and/or abdominal pain), Headache, Myalgia, and Shivering. Fever = axillary temperature ≥37.5°C. Any = occurrence of any general symptoms regardless of their intensity grade or relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 Fever = axillary temperature >39.0°C. Related = general symptom assessed by the investigator as causally related to vaccination.|During the 7 day (Days 0-6) post vaccination, after each dose (D) and across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.||Subjects|||Number
665064|NCT01777321|Primary|Number of Subjects With Solicited Local Symptoms|The solicited local symptoms assessed were: Arm movement/range of motion of the vaccinated arm, Injection site pruritus, Pain, Redness, and Swelling. Any = occurrence of any local symptom regardless of their intensity grade. Grade 3 Pain = Significant pain at rest that prevented normal every day activities. Grade 3 Injection site pruritus = Significant pruritus that prevented normal every day activities. Grade 3 impairment of arm movement/range of motion = Significant impairment of arm movement/range of motion that prevented normal every day activities.|During the 7 day (Days 0-6) post vaccination, after each dose (D) and across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.||Subjects|||Number
665065|NCT01777321|Primary|Anti-gE Antibody Concentrations||Before vaccination (PRE), at two months after dose 1 (M2) and three months after Dose 2 (M3)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had met all eligibility criteria and for whom data concerning immunogenicity outcome measures were available.||mIU/mL||Standard Deviation|Median
665066|NCT01777321|Primary|Number of Subjects With Vaccine Response for Anti-gE Antibody Concentrations|Vaccine response was defined as: For initially seronegative subjects, antibody concentration at post-vaccination ≥ 4 fold the cut-off for Anti-gE (4x18 mIU/mL); for initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration.|At two months after Dose 1 (M2) and three months after Dose 2 (M3)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had met all eligibility criteria and for whom data concerning immunogenicity outcome measures were available.||Subjects|||Number
665067|NCT01777321|Primary|Anti-gE Antibody Concentrations||Before vaccination (PRE), two months after Dose 1 (M2) and three months after Dose 2 (M3)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had met all eligibility criteria and for whom data concerning immunogenicity outcome measures were available.||mIU/mL||95% Confidence Interval|Geometric Mean
665068|NCT01777321|Primary|Number of Subjects With Anti-Glycoprotein E (Anti-gE) Antibody Concentrations ≥ 18 mIU/mL||Before vaccination (PRE), two months after Dose 1 (M2) and three months after Dose 2 (M3)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had met all eligibility criteria and for whom data concerning immunogenicity outcome measures were available.||Subjects|||Number
665117|NCT01776645|Other Pre-specified|Change in Overall Health and Well-being|As assessed by Ryff's psychological well-being scales|Baseline and end of 9-week treatment protocol||||||
665118|NCT01776645|Other Pre-specified|Change in Emotional Distress|As assessed by the Hospital Anxiety and Depression Scale|Baseline and end of 9-week treatment protocol||||||
665069|NCT01777282|Secondary|Time to Study Withdrawal Due to Hyperglycemia|Participants who experienced persistent hyperglycemia after uptitration were to be withdrawn from the study. Hyperglycemia is defined as a fasting plasma glucose >=280 mg/dL (>=15.5 mmol/L) from >=Week 2 to <Week 12 or >=230 mg/dL (>=12.8 mmol/L) from >=Week 12 to <Week 52.|Week 52|Intent-to-Treat (Last Observation Carried Forward) Population. Only participants who were withdrawn due to hyperglycemia were analyzed.||Weeks||Standard Deviation|Mean
665070|NCT01777282|Secondary|Change From Baseline in Body Weight at Week 52|The Baseline body weight value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the body weight value at Week 52 minus the value at Baseline. Participants who discontinued from study treatment before Week 52 had their last on-treatment, post-Baseline weight observation carried forward for the analysis.|Baseline and Week 52|Intent-to-Treat (Last Observation Carried Forward) Population||Kilograms (kg)||Standard Deviation|Mean
665071|NCT01777282|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52|FPG is an indicator of efficacy. The Baseline FPG value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the FPG value at Week 52 minus the FPG value at Baseline. Participants who discontinued from study treatment before Week 52 had their last on-treatment, post-Baseline FPG observation carried forward for the analysis.|Baseline and Week 52|Intent-to-Treat (Last Observation Carried Forward) Population. Only those participants with valid post-Baseline results (within 14 days of last exposure to treatment) were analyzed.||Milligrams per deciliter (mg/dL)||Standard Deviation|Mean
665072|NCT01777282|Secondary|Percentage of Participants Achieving Clinically Meaningful Levels of HbA1c (i.e., the Percentage of Participants Achieving Treatment Goal of <6.5% and <7.0% at Week 52)|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3 month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Participants who discontinued from study treatment before Week 52 had their last on-treatment, post-Baseline HbA1c observation carried forward for the analysis. Clinically meaningful levels of response in HbA1c are defined as <6.5% and <7.0%.|Week 52|Intent-to-Treat (Last Observation Carried Forward) Population||Percentage of participants|||Number
665073|NCT01777282|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 52|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the value at Week 52 minus the value at Baseline. Participants who discontinued from study treatment before Week 52 had their last on-treatment, post-Baseline HbA1c observation carried forward for the analysis.|Baseline and Week 52|Intent-to-Treat (Last Observation Carried Forward) Population: all enrolled participants who received at least 1 dose of study medication and who had at least one HbA1c post-Baseline assessment.||Percentage of HbA1c in the blood||Standard Deviation|Mean
665074|NCT01777282|Primary|Number of Participants With Any Hypoglycemic Event|Hypoglycemia events are defined with respect to low plasma glucose level, mostly accompanied by typical symptoms and/or assistance needed from third party with glucose administration. These events were reported by the investigators upon verification of the plasma glucose levels, symptoms and assistance recorded by the participants, and/or plasma glucose values obtained from laboratory evaluations.|From Baseline through Week 52|Safety Population: all participants who received at least 1 dose of study treatment.||Participants|||Number
665075|NCT01777282|Primary|Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of non-serious AEs and SAEs. Non-serious hypoglycemia events are not included.|From Baseline through Week 52|Safety Population: all participants who received at least 1 dose of study treatment.||Participants|||Number
665076|NCT01777269|Secondary|Change From Baseline in Total MSHQ Scores From Baseline at 12 Months Among Participants With IPSS Improvement of >=25 Percent|Participants with change from baseline in total MSHQ scores with good BPH symptomatic response (measured by improvement in IPSS)were analysed.Change from BL at the scheduled post-baseline time points were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Month 12 value(s) minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)|Baseline and Month 12|ITT Population; Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)||Scores on a scale||Standard Error|Least Squares Mean
665077|NCT01777269|Secondary|Change From Baseline in Total MSHQ Scores From Baseline at 12 Months Among Participants With IPSS Improvement of >=2 Points and >=3 Points|Total MSHQ score is composed of 3 domain scores: ES+EjS+SS and the score ranges from 7-80, with higher scores indicating greater sexual function. Par. with change from baseline in total MSHQ scores with good BPH symptomatic response (measured by improvement in IPSS)were analysed. Change from BL at the scheduled post-baseline time points were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Month 12 value(s) minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)|Baseline and Month 12|ITT Population||Scores on a scale||Standard Error|Least Squares Mean
665078|NCT01777269|Secondary|Change From Baseline in Perception of Treatment Benefit/Satisfaction With Treatment (Patient Perception of Study Medication - PPSM Questionnaire Scores) at 2 Weeks, 1, 3, 6, 9, and 12 Months|Patient Perception of Study Medication (PPSM) is a 12-item questionnaire designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms. The total PPSM score ranges from 7 to 49, with higher scores indicating lower satisfaction. Change from BL were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the subject took at least one dose of DB study drug; change from BL was calculated as Week 2, Months 1, 3, 6, 9, 12 values minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)|Baseline, Week 2, Month 1, 3, 6, 9 and 12|ITT Population||Scores on a scale||Standard Error|Least Squares Mean
665079|NCT01777269|Secondary|Change From Baseline in Quality of Life (BPH Impact Index –BII Scores) at 2 Weeks, 1, 3, 6, 9, and 12 Months|The BPH Impact Index (BII) is a 4-item, self-administered questionnaire evaluating the impact of urinary problems on overall health and activity. Total scores range from 0 to 13; higher scores represent increased perceived impact of benign prostatic hyperplasia-lower urinary tract symptoms on overall health. Change from BL were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the subject took at least one dose of DB study drug; change from BL was calculated as Week 2, Months 1, 3, 6, 9 and 12 values minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)|Baseline and Month 1, 3, 6, 9 and 12|ITT Population||Scores on a scale||Standard Error|Least Squares Mean
665080|NCT01777269|Secondary|Change From Baseline in International Prostate Symptom Score (IPSS) Scores Using the Observed Cases Approach at 2 Weeks, 1, 3, 6, 9, and 12 Months|The IPSS questionnaire is a 7-item self-administered questionnaire designed to quantify urinary symptoms: Q1, incomplete emptying; Q2, frequency; Q3, intermittency; Q4, urgency; Q5, weak stream; Q6, straining; Q7, nocturia. The score can range from 0 to 35: mild (0 to 7), moderate (8 to 19), or severe (20 to 35). Change from BL were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Week 2, Months 1, 3, 6, 9 and 12 values minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)|Baseline and Month 1, 3, 6, 9 and 12|ITT Population||Scores on a scale||Standard Error|Least Squares Mean
665081|NCT01777269|Secondary|Change From Baseline in Satisfaction Score at 1, 3, 6, 9 and 12 Months|Satisfaction scale is a domain of MSHQ to assess sexual relationship. SS is the sum of score for questions 13 to 18. The score ranges from 6 (extremely dissatisfied) to 30 (extremely satisfied). Change from BL at the scheduled post-baseline time points were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Month 1, 3, 6, 9 and 12 values minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)|Baseline and Month 1, 3, 6, 9 and 12|ITT Population||Scores on a scale||Standard Deviation|Mean
665082|NCT01777269|Secondary|Change From Baseline in Ejaculatory Dysfunction (EjD) at 1, 3, 6, 9 and 12 Months|Ejaculation scale is a domain of MSHQ to assess ejaculatory dysfunction. EjS is the sum of score for questions 5 to 11. The score ranges from 1 (could not ejaculate) to 35 (strong ejaculation). Change from BL at the scheduled post-baseline time points were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Month 1, 3, 6, 9 and 12 values minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)|Baseline and Month 1, 3, 6, 9 and 12|ITT Population||Scores on a scale||Standard Error|Least Squares Mean
665083|NCT01777269|Secondary|Change From Baseline in Erectile Dysfunction (ED) at 1, 3, 6, 9 and 12 Months|Erection scale is a domain of MSHQ to assess erectile dysfunction. ES is the sum of score for questions 1 to 3. The score ranges from 0 (no erection) to 15 (strong erection). Change from BL at the scheduled post-baseline time points were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Month 1, 3, 6, 9 and 12 values minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)|Baseline and Month 1, 3, 6, 9 and 12|ITT Population||Scores on a scale||Standard Error|Least Squares Mean
665084|NCT01777269|Secondary|Number of Participants Reaching Various Thresholds of Change in Total MSHQ From Baseline at 12 Months|Participants reaching thresholds of change in total MSHQ were assessed. Threshold values are defined as multiplicative factor. Threshold included +10 points, +20 points, +25 points, -10 points, -20 points, -25 points; where “+” indicates improvement and “-”indicates worsening. Treatment comparisons were done based on categories defined by these thresholds using Mantel-Haenszel test|Baseline and 12 months|ITT Population; Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles).||Participants|||Number
665085|NCT01777269|Secondary|Change From Baseline in Scores From the Full Men’s Sexual Health Questionnaire (MSHQ) at 1, 3, 6 and 9 Months|Total MSHQ score is composed of 3 domain scores: ES=sum of score for Q 1 to 3(ranges from 0 to 15), EjS=sum of scores for Q5 to 11(ranges from 1 to 35), SS=sum of scores for Q13 to 18(ranges from 6 to 30). Total MSHQ score=ES+EjS+SS and the score ranges from 7-80, with higher scores indicating greater sexual function. Change from BL at scheduled post-BL time points were analysed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Month 1, 3, 6, 9 values minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)|Baseline and Month 1, 3, 6, and 9|ITT Population||Scores on a scale||Standard Error|Least Squares Mean
665086|NCT01777269|Primary|Changes From Baseline (BL) in Total Score From the Full Men’s Sexual Health Questionnaire (MSHQ) at 12 Months|Total MSHQ score is composed of 3 domain scores: Erection score(ES)=sum of score for Questions (Q) 1 to 3(ranges from 0 to 15), Ejaculation score(EjS)=sum of scores for Q5 to 11(ranges from 1 to 35), Satisfaction score(SS)=sum of scores for Q13 to 18(ranges from 6 to 30). Total MSHQ score=ES+EjS+SS. The total MSHQ score ranges from 7-80, with higher scores indicating greater sexual function. Change from BL at scheduled post-BL time points were analyzed using a mixed model repeated measures (MMRM) analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest double-blind (DB) treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Month 12 value(s) minus BL value(s)|Baseline and 12 months|Intent-to-Treat (ITT): All randomized par. regardless of whether or not treatment was administered. Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles).||Scores on a scale||Standard Error|Least Squares Mean
665087|NCT01777217|Primary|Change From Baseline to End of Study Measured by the American Urology Association Symptom Score Questionnaire (AUASS).|The AUASS score range is 1-7 (mild), 8-19 (moderate) and 20-35 (severe). The AUASS asks 7 questions scored 0-5, the scores are summed for the total score.|baseline and 16 weeks|||Scores on a scale||Standard Deviation|Median
665088|NCT01777191|Secondary|SQAAQ Item Scores: Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO)|"The SQAAQ is a self-administered questionnaire which provides an assessment of ease of use and confidence with using a device to administer a subcutaneous injection of drug. Participants and injection assistants responded to questionnaire items using a 7-point Likert scale (from Strongly Disagree to Strongly Agree). 1 represents Strongly Disagree while 7 represents Strongly Agree. The ease of use and confidence of ixekizumab subcutaneous administrations across drug delivery device groups were evaluated by SQAAQ item scores at each post baseline visit."|Baseline, Week 4 and Week 8|All randomized participants.||units on a scale||Standard Deviation|Mean
665089|NCT01777191|Secondary|Percentage of Participants With Anti-Ixekizumab Antibodies|The percentage of participants with treatment-emergent positive anti-ixekizumab antibodies at anytime post-baseline were summarized by drug delivery device group. Percentage was calculated based on the number of evaluable participants and was calculated by number of participants with treatment-emergent positive anti-ixekizumab antibodies / number of evaluable participants * 100%.|Baseline to Week 12|All randomized participants who received a least 1 dose of study drug during the Treatment Period and had evaluable data.||percentage of participants|||Number
665090|NCT01777191|Secondary|Percentage of Device Operation Failures|Device operation failure (that is, incomplete dose administration) was defined as an event during the treatment period (week 0 to week 12) when the participant indicated that a complete dose of ixekizumab was not delivered and/or the drug delivery device did not perform as expected per the directions for use.|Baseline through Week 12|All randomized participants.||percentage of incomplete injections|Participants||Number
665091|NCT01777191|Secondary|Percentage of Participants With a Static Physician Global Assessment (sPGA) (0)|The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's Ps was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe).|Week 12|All randomized participants. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for NRI analysis.||percentage of participants|||Number
665092|NCT01777191|Secondary|Percentage of Participants With a Static Physician Global Assessment (sPGA) (0,1): Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis. Measure: Static Physician Global Assessment (sPGA)|"The sPGA is the physician's determination of the participant's Psoriasis (Ps) lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's Ps was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of 0 or 1 with at least a 2-point improvement from baseline."|Week 12|All randomized participants. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for NRI analysis.||percentage of participants|||Number
665093|NCT01777191|Secondary|Percentage of Participants Achieving a ≥75%, ≥ 90% and 100% Improvement in Psoriasis Area and Severity Index (PASI): Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis. Measure: Psoriasis Area and Severity Index (PASI)|PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 or no Ps to 72 for the most severe disease. Participants achieving PASI 75, 90, or 100 are defined as having an improvement of at least 75%, 90%, or of 100%, respectively, in the PASI scores compared to baseline.|Week 12|All randomized participants. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for Non-Responder Imputation (NRI) analysis.||percentage of participants|||Number
665119|NCT01776645|Primary|Change in Chronic Pain Acceptance Questionnaire||Baseline and end of 9-week treatment protocol||||||
665094|NCT01777191|Secondary|PK: AUC 0-tlast by Body Weight|AUC 0-tlast by body weight of Ixekizumab, after the 160 mg starting dose was administered on Day 0. AUC 0-tlast is equal to AUC 0-14 days where the last time point was 14 days ± 24 hours. Body weight is defined by (Low: <80 kg, Medium: 80-100 kg, or High: >100 kg).|Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration)|All randomized participants who received at least 1 dose of study drug and had evaluable PK data for AUC.||µg*day/mL||90% Confidence Interval|Geometric Mean
665095|NCT01777191|Secondary|PK: Cmax by Body Weight|Cmax by body weight of Ixekizumab, after the 160 mg starting dose was administered on Day 0. Body weight is defined by (Low: <80 kilogram (kg), Medium: 80-100 kg, or High: >100 kg).|Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration)|All randomized participants who received at least 1 dose of study drug and had evaluable PK data for Cmax.||µg/mL||95% Confidence Interval|Geometric Mean
665096|NCT01777191|Secondary|PK: AUC 0-tlast by Site of Injection (Arm, Thigh or Abdomen)|AUC 0-tlast by site of injection of Ixekizumab, after the 160 mg starting dose was administered on Day 0. AUC 0-tlast is equal to AUC 0-14 days where the last time point was 14 days ± 24 hours.|Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration)|All randomized participants who received at least 1 dose of study drug and had evaluable PK data for AUC.||µg*day/mL||90% Confidence Interval|Geometric Mean
665097|NCT01777191|Secondary|PK: Cmax of Ixekizumab by Site of Injection (Arm, Thigh or Abdomen)|Cmax by site of injection of Ixekizumab, after the 160 mg starting dose was administered on Day 0.|Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration)|All randomized participants who received at least 1 dose of study drug and had evaluable PK data for Cmax.||µg/ml||90% Confidence Interval|Geometric Mean
665098|NCT01777191|Primary|PK: Area Under the Concentration Time Curve From Time Zero to Last Measured Concentration Value (AUC 0-[Tlast]) by Drug Delivery Device|AUC 0-tlast by drug delivery device (prefilled syringe or auto-injector) of Ixekizumab, after the 160 mg starting dose was administered on Day 0. AUC 0-tlast is equal to AUC 0-14 days where the last time point was 14 days ± 24 hours.|Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration)|All randomized participants who received at least 1 dose of study drug and had evaluable PK data for AUC.||micrograms*day/milliliter (µg*day/mL)||90% Confidence Interval|Geometric Mean
665099|NCT01777191|Primary|Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) by Drug Delivery Device|Cmax by drug delivery device (prefilled syringe or auto-injector) of Ixekizumab, after the 160 mg starting dose was administered on Day 0.|Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration)|All randomized participants who received at least 1 dose of study drug and had evaluable PK data for Cmax.||micrograms/milliliter (µg/mL)||90% Confidence Interval|Geometric Mean
665100|NCT01777126|Secondary|Severity Grade of Postoperative Complications.|Severity grade of postoperative complications (POCs) was compared between the two groups. The severity grade of POCs were classified using the Clavien-Dindo Classification. Per patient, multiple complications are possible.|30 days postoperative|||number of POCs per severity grade|||Number
665101|NCT01777126|Secondary|The Type of Postoperative Complications.|The type of postoperative complications (POCs) were compared between the two groups. The type of POCs were classified using the Clavien-Dindo Classification. Herein POCs were classified into 8 categories (1. Infection, 2. Fistula/leak, 3. Bleeding/hematoma, 4. Gastrointestinal, 5. Cardiopulmonary, 6. Neurologic, 7. pain and 8. Other) and stratified by their severity grade (Table 2). Per patient, multiple complications are possible.|30 days postoperative|||number per type of POC|||Number
665102|NCT01777126|Secondary|Patients With a Catheter Related Bloodstream Infection|Patients with a catheter related bloodstream infection were compared between the two groups|30 days postoperative|||participants|||Number
665103|NCT01777126|Secondary|The Number of Postoperative Complications Per Patient.|The number of postoperative complications per patient was compared between the two groups.|30 days postoperative|||number of postoperative complications||Inter-Quartile Range|Median
665104|NCT01777126|Secondary|Patients With One or More Postoperative Complication.|Number of patients with one or more postoperative complication were compared betweent the two groups.|30 days postoperative|||participants|||Number
665105|NCT01777126|Secondary|The Time to Resumption of Full Diet.|The time to resumption of full diet between the two groups was compared.|30 days postoperative|||day||Inter-Quartile Range|Median
665106|NCT01777126|Secondary|Number of Administered PN|Number of administered PN per group|30 days postoperative|||number of PN|||Number
665107|NCT01777126|Secondary|Successful Implementation Rate of the ONP in the Experimental Group|Successful implementation of the ONP was achieved if the patient followed the protocol and did not need PN.|30 days postoperative|The number of patients with successful implementation of the ONP in the experimental group.||participants|||Number
665108|NCT01777126|Primary|the Postoperative Length of Stay|The primary outcome measure was the interval from surgery to discharge. Discharge means that the patient returns to his home.|one month after surgery|Primary outcome measure was interval from surgery to discharge. Discharge means that the patient returns back to his home and not to a rehabilitation center.||day||Inter-Quartile Range|Median
665109|NCT01776645|Secondary|Change in Brief Pain Inventory|Interference score - Interference as measured by a 0 to 10 numerical rating scale. 0 = does not interfere, 10 = completely interferes|Baseline to end of 9-week treatment protocol|2 participants excluded from analysis: 1 did not complete the final questionnaire battery, 1 reported no pain at baseline and thus could not be included as a patient with chronic pain||units on a scale||Standard Deviation|Mean
665110|NCT01776645|Other Pre-specified|Change in Compassion|As assessed by Pommier's Compassion for Other's Scale|Baseline and end of 9-week treatment protocol||||||
665111|NCT01776645|Other Pre-specified|Change in Compassion|As assessed by Compassionate Love Scale adapted for close other|Baseline and end of 9-week treatment protocol||||||
665112|NCT01776645|Other Pre-specified|Change in Overall Health and Well-being|As assessed by PROMIS Global Health Scale|Baseline and end of 9-week treatment protocol||||||
665113|NCT01776645|Other Pre-specified|Change in Emotional Distress|As assessed by the PROMIS Social Isolation Scale|Baseline and end of 9-week treatment protocol||||||
665114|NCT01776645|Other Pre-specified|Change in Emotional Distress|As Assessed by the PROMIS Anger Scale|Baseline and end of 9-week treatment protocol||||||
665115|NCT01776645|Other Pre-specified|Qualitative Measures|Qualitative analysis of interviews|Baseline and end of 9-week treatment protocol||||||
665120|NCT01776645|Primary|Change in Brief Pain Inventory|Intensity - pain severity as measured by a 0 to 10 visual analogue scale. 0 = no pain, 10 = worst pain imaginable|Baseline and end of 9-week treatment protocol|2 participants excluded from analysis: 1 did not complete the final questionnaire battery, 1 reported no pain at baseline and thus could not be included as a patient with chronic pain||units on a scale||Standard Deviation|Mean
665121|NCT01776554|Secondary|The Percentages Of Subjects Aged 9 to <18 Years, Achieving Seroconversion Against A/H5N1 Strain|"Immunogenicity was assessed in terms of percentages of subjects aged 9 to <18 years achieving seroconversion in HI titers, 3 weeks after first vaccination, 3 weeks after second vaccination and 12 months after second vaccination of either low dose or high dose aH5N1c vaccine according to the CHMP criterion.
Seroconversion is defined as the percentages of subjects with a prevaccination HI titer <10, a postvaccination titer ≥40; or in subjects with prevaccination HI titer ≥10, and a minimum four-fold rise in postvaccination HI antibody titer.
The criterion is met according to the European (CHMP) guideline if the percentage of subjects achieving seroconversion (at day 43) is >40%."|Day 22, day 43 and day 387|Analysis was done the FAS.||Percentages of subjects||95% Confidence Interval|Number
665122|NCT01776554|Secondary|The Percentages Of Subjects Aged 3 to <9 Years, Achieving Seroconversion Against A/H5N1 Strain|"Immunogenicity was assessed in terms of percentages of subjects aged 3 to <9 years achieving seroconversion in HI titers, 3 weeks after first vaccination, 3 weeks after second vaccination and 12 months after second vaccination of either low dose or high dose aH5N1c vaccine according to the CHMP criterion.
Seroconversion is defined as the percentages of subjects with a prevaccination HI titer <10, a postvaccination titer ≥40; or in subjects with prevaccination HI titer ≥10, and a minimum four-fold rise in postvaccination HI antibody titer.
The criterion is met according to the European (CHMP) guideline if the percentage of subjects achieving seroconversion (at day 43) is >40%."|Day 22, day 43 and day 387|Analysis was done on FAS.||Percentages of subjects||95% Confidence Interval|Number
665123|NCT01776554|Secondary|The Percentages Of Subjects Aged 6 to <36 Months, Achieving Seroconversion Against A/H5N1 Strain|"Immunogenicity was assessed in terms of percentages of subjects aged 6 to <36 months achieving seroconversion in HI titers, 3 weeks after first vaccination, 3 weeks after second vaccination and 12 months after second vaccination of either low dose or high dose aH5N1c vaccine according to the CHMP criterion.
Seroconversion is defined as the percentages of subjects with a prevaccination HI titer <10, a postvaccination titer ≥40; or in subjects with prevaccination HI titer ≥10, and a minimum four-fold rise in postvaccination HI antibody titer.
The criterion is met according to the European (CHMP) guideline if the percentage of subjects achieving seroconversion (at day 43) is >40%."|Day 22, day 43 and day 387|Analysis was done on the FAS.||Percentages of subjects||95% Confidence Interval|Number
665124|NCT01776554|Secondary|Percentages Of Subjects Aged 9 to <18 Years, With HI Titers ≥40 Against A/H5N1 Strain|"Immunogenicity was assessed in terms of percentage of subjects aged 9 to <18 years, achieving HI titers ≥40, 3 weeks after first vaccination, 3 weeks after second vaccination and 12 months after second vaccination of either low dose or high dose of aH5N1c according to the CHMP criterion.
European Licensure (CHMP) criterion is met if the percentage of subjects achieving (at day 43) HI titers ≥40 is >70%."|Day 1, day 22, day 43 and day 387.|Analysis was done on the FAS.||Percentages of subjects||95% Confidence Interval|Number
665125|NCT01776554|Secondary|Percentages Of Subjects Aged 3 to <9 Years, With HI Titers ≥40 Against A/H5N1 Strain|"Immunogenicity was assessed in terms of percentage of subjects aged 3 to <9 years, achieving HI titers ≥40, 3 weeks after first vaccination, 3 weeks after second vaccination and 12 months after second vaccination of either low dose or high dose of aH5N1c according to the CHMP criterion.
European Licensure (CHMP) criterion is met if the percentage of subjects achieving (at day 43) HI titers ≥40 is >70%."|Day 1, day 22, day 43 and day 387.|Analysis was done on the FAS.||Percentages of subjects||95% Confidence Interval|Number
665126|NCT01776554|Secondary|Percentages Of Subjects Aged 6 to <36 Months, With HI Titers ≥40 Against A/H5N1 Strain|"Immunogenicity was assessed in terms of percentage of subjects aged 6 to <36 months, achieving HI titers ≥40, 3 weeks after first vaccination, 3 weeks after second vaccination and 12 months after second vaccination of either low dose or high dose of aH5N1c according to the CHMP criterion.
European Licensure (CHMP) criterion is met if the percentage of subjects achieving (at day 43) HI titers ≥40 is >70%."|Day 1, day 22, day 43 and day 387.|Analysis was done on the FAS.||Percentages of subjects||95% Confidence Interval|Number
665127|NCT01776554|Secondary|Geometric Mean Ratios Against A/H5N1 Strain Following 2-Dose Vaccination Schedule Of Either Low Dose Or High Dose AH5N1c Vaccine in Subjects Aged 9 to <18 Years.|"Immunogenicity was measured as the geometric mean ratio (GMR). The ratio of postvaccination to prevaccination HI GMTs, 3 weeks after first vaccination, 3 weeks after second vaccination and 12 months after second vaccination with either low dose or high dose of aH5N1c in subjects aged 9 to <18 years is reported.
As no CHMP criteria are established for the pediatric population, criteria given for subjects 18-60 years of age were applied.
The criterion is met according to the European Committee for Medicinal Products for Human Use (CHMP) criteria if the geometric mean increase GMR (day 43/day 1) in HI antibody titer is >2.5."|Day 1, day 22, day 43 and day 387|Analysis was done on the FAS.||Ratio||95% Confidence Interval|Geometric Mean
665128|NCT01776554|Secondary|Geometric Mean Ratios Against A/H5N1 Strain Following 2-Dose Vaccination Schedule Of Either Low Dose Or High Dose AH5N1c Vaccine in Subjects Aged 3 to <9 Years.|"Immunogenicity was measured as geometric mean ratio (GMR). The ratio of postvaccination to prevaccination HI GMTs, 3 weeks after first vaccination, 3 weeks after second vaccination and 12 months after second vaccination with either low dose or high dose of aH5N1c in subjects aged 3 to <9 years is reported.
As no CHMP criteria are established for the pediatric population, criteria given for subjects 18-60 years of age were applied.
The criterion is met according to the European Committee for Medicinal Products for Human Use (CHMP) criteria if the geometric mean increase GMR (day 43/day 1) in HI antibody titer is >2.5."|Day 1, day 22, day 43 and day 387|Analysis was done on the FAS.||Ratio||95% Confidence Interval|Geometric Mean
665168|NCT01775995|Other Pre-specified|Alcohol Use|Percentage of participants endorsing any alcohol use during the past 28 days was assessed using the Timeline Follow-Back Method.|26 weeks|One Meditation-CBT and one Wait-list Control participant did not provide data for this measure at 26 week follow-up. Results for this measure are based on the number of participants analyzed.||percentage using alcohol|||Number
665203|NCT01775553|Primary|Safety and Efficacy of High Dose Carfilzomib|The safety and efficacy of high dose carfilzomib who developed disease progression on the standard dosing and schedule of carfilzomib as measured by number of participants with adverse events|up to 4 years|||Participants|||Count of Participants
665129|NCT01776554|Secondary|Geometric Mean Ratios Against A/H5N1 Strain Following 2-Dose Vaccination Schedule Of Either Low Dose Or High Dose AH5N1c Vaccine in Subjects Aged 6 to <36 Months.|"Immunogenicity was measured as the geometric mean ratio (GMR). The ratio of postvaccination to prevaccination HI GMTs, 3 weeks after first vaccination, 3 weeks after second vaccination and 12 months after second vaccination with either low dose or high dose of aH5N1c in subjects aged 6 to <36 months is reported.
The criterion is met according to the European Committee for Medicinal Products for Human Use (CHMP) criteria if the geometric mean increase GMR (day 43/day 1) in HI antibody titer is >2.5.
As no CHMP criteria are established for the pediatric population, criteria given for subjects 18-60 years of age were applied."|Day 1, day 22, day 43 and day 387|Analysis was done on the FAS.||Ratio||95% Confidence Interval|Geometric Mean
665130|NCT01776554|Primary|Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination|Safety was assessed using the number of subjects who reported any unsolicited adverse events, adverse events possibly or probably related to study vaccine, serious adverse events (SAEs), new onset of chronic diseases (NOCDs), medically attended AEs, AEs of special interest (AESIs), AEs leading to withdrawal from study following vaccination with either low or high dose of aH5N1c vaccine.|Any unsolicited AEs - day 1 through day 22 after any vaccination; SAEs, NOCDs. medically attended AEs, AESIs, AEs leading to study withdrawal- day 1 to day 387|Analysis was done on the safety dataset.||Number of subjects|||Number
665131|NCT01776554|Primary|Number of Subjects (≥6 Years – 17 Years) Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination|Safety was assessed using the number of subjects who reported solicited local and systemic adverse events following vaccination with either low or high dose of aH5N1c vaccine.|From day 1 through day 7 after any vaccination.|Analysis was done on the safety dataset.||Number of subjects|||Number
665132|NCT01776554|Primary|Number of Subjects (6 Month - <6 Years) Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination|Safety was assessed using the number of subjects who reported solicited local and systemic adverse events following vaccination with either low or high dose of aH5N1c vaccine.|From day 1 through day 7 after each vaccination.|Analysis was done on the safety dataset, i.e. the subjects in the exposed population who provided postvaccination safety data.||Number of subjects|||Number
665133|NCT01776554|Primary|The Percentages Of Subjects Aged 9 to <18 Years, Achieving Seroconversion Against A/H5N1 Strain|"Immunogenicity was measured in terms of the percentages of subjects aged 9 to <18 years, achieving seroconversion or significant increase in HI titer against the vaccine strain, three weeks after receiving two injections of low dose or high dose of aH5N1c vaccine according to the CBER criteria.
Seroconversion is defined as the percentages of subjects with a prevaccination HI titer <10, a postvaccination titer ≥40; or in subjects with prevaccination HI titer ≥10, and a minimum four-fold rise in postvaccination HI antibody titer.
CBER criterion is met if the lower limit of the two-sided 95% CI for the percentages of subjects achieving seroconversion for HI antibody titer meets or exceeds 40%."|Three weeks after 2nd vaccination (day 43)|This analysis was done on the FAS.||Percentages of subjects||95% Confidence Interval|Number
665134|NCT01776554|Primary|The Percentages Of Subjects Aged 3 to <9 Years, Achieving Seroconversion Against A/H5N1 Strain|"Immunogenicity was measured in terms of the percentages of subjects aged 3 to <9 years, achieving seroconversion or significant increase in HI titer against the vaccine strain, three weeks after receiving two injections of low dose or high dose of aH5N1c vaccine according to the CBER criteria.
Seroconversion is defined as the percentages of subjects with a prevaccination HI titer <10, a postvaccination titer ≥40; or subjects with prevaccination HI titer ≥10, and a minimum four-fold rise in postvaccination HI antibody titer.
CBER criterion is met if the lower limit of the two-sided 95% CI for the percentages of subjects achieving seroconversion for HI antibody titer meets or exceeds 40%."|Three weeks after 2nd vaccination (day 43)|Analysis was done on FAS.||Percentages of subjects||95% Confidence Interval|Number
665135|NCT01776554|Primary|The Percentages Of Subjects Aged 6 to <36 Months, Achieving Seroconversion Against A/H5N1 Strain|"Immunogenicity was measured in terms of the percentages of subjects aged 6 to <36 months, achieving seroconversion or significant increase in HI titer against the vaccine strain, three weeks after receiving two injections of low dose or high dose of aH5N1c vaccine according to the CBER criteria.
Seroconversion is defined as the percentages of subjects with a prevaccination HI titer <10, a postvaccination titer ≥40; or in subjects with prevaccination HI titer ≥10, and a minimum four-fold rise in postvaccination HI antibody titer.
CBER criterion is met if the lower limit of the two-sided 95% CI for the percentages of subjects achieving seroconversion for HI antibody titer meets or exceeds 40%."|Three weeks after 2nd vaccination (day 43)|Analysis was done was FAS.||Percentages of subjects||95% Confidence Interval|Number
665136|NCT01776554|Primary|The Percentages Of Subjects Aged 9 to <18 Years, Achieving HI Titers ≥40 Against A/H5N1 Strain|"The optimal aH5N1c vaccine formulation was evaluated in terms of percentages of subjects aged 9 to <18 years, achieving HI titers ≥40 against homologous A/H5N1 strain, three weeks after second vaccination with either low dose or high dose of aH5N1c vaccine, according to the CBER criterion.
As there is no CBER criteria defined for children, immunogenicity was evaluated using CBER criterion applicable for adults (18-64 years).
CBER criterion is met if the lower limit of the two-sided 95% CI for the percentages of subjects achieving HI titer ≥40 meets or exceeds 70%."|Three weeks after 2nd vaccination (day 43)|Analysis was done on FAS.||Percentages of subjects||95% Confidence Interval|Number
665137|NCT01776554|Primary|The Percentages Of Subjects Aged 3 to <9 Years, Achieving HI Titers ≥40 Against A/H5N1 Strain|"The optimal aH5N1c vaccine formulation was evaluated in terms of percentages of subjects aged 3 to <9 years, achieving HI titers ≥40 against homologous A/H5N1 strain, three weeks after second vaccination with either low dose or high dose of aH5N1c vaccine, according to the CBER criterion.
As there is no CBER criteria defined for children, immunogenicity was evaluated using CBER criterion applicable for adults (18-64 years).
CBER criterion is met if the lower limit of the two-sided 95% CI for the percentages of subjects achieving HI titer ≥40 meets or exceeds 70%."|Three weeks after 2nd vaccination (day 43)|Analysis was done on FAS.||Percentages of subjects||95% Confidence Interval|Number
665169|NCT01775995|Other Pre-specified|Alcohol Use|Percentage of participants endorsing any alcohol use during the past 28 days was assessed using the Timeline Follow-Back Method.|8 weeks|One Meditation-CBT participant did not provide data for this measure at 8 week follow-up. Results for this measure are based on the number of participants analyzed.||percentage using alcohol|||Number
665170|NCT01775995|Other Pre-specified|Alcohol Use|Percentage of participants endorsing any alcohol use during the past 28 days was assessed using the Timeline Follow-Back Method.|Baseline|||percentage using alcohol|||Number
665138|NCT01776554|Primary|The Percentages Of Subjects Aged 6 to <36 Months, Achieving Hemagglutination Inhibition (HI) Titers ≥40 Against A/H5N1 Strain|"The optimal aH5N1c vaccine formulation was evaluated in terms of percentages of subjects aged 6 to <36 months, achieving HI titers ≥40 against homologous A/H5N1 strain, three weeks after second vaccination with either low dose or high dose of aH5N1c vaccine, according to the Center for Biologics Evaluation and Research (CBER) criterion.
As there is no CBER criteria defined for children, immunogenicity was evaluated using CBER criterion applicable for adults (18-64 years).
CBER criterion is met if the lower limit of the two-sided 95% confidence interval (CI) for the percentages of subjects achieving HI titer ≥40 meets or exceeds 70%."|Three weeks after 2nd vaccination (day 43)|Analysis was done on the Full Analysis Set (FAS) i.e., the subjects who actually received at least one dose of study vaccination and provided at least one evaluable serum sample both before (baseline) and after vaccination.||Percentages of subjects||95% Confidence Interval|Number
665139|NCT01776541|Secondary|Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain.|"Immunogenicity was assessed in terms of percentages of subjects achieving seroconversion in HI titers, 3 weeks after first vaccination, 3 weeks after second vaccination and 12 months after second vaccination of either low dose or high dose aH5N1c vaccine according to the CHMP criterion.
Seroconversion is defined as: a) for subjects with a prevaccination HI titer <10, a postvaccination titer ≥40; or b) for subjects with prevaccination HI titer ≥10, a minimum four-fold rise in postvaccination HI antibody titer.
The criterion is met according to the European (CHMP) guideline if the percentage of subjects achieving seroconversion (at day 43) is >40%."|Day 22, day 43 and day 387|Analysis was done on the FAS set.||Percentages of subjects||95% Confidence Interval|Number
665140|NCT01776541|Secondary|Percentages Of Subjects With HI Titers ≥40 Against A/H5N1 Strain.|"Immunogenicity was assessed in terms of percentage of subjects achieving HI titers ≥40, 3 weeks after first vaccination, 3 weeks after second vaccination and 12 months after second vaccination of either low dose or high dose of aH5N1c according to the CHMP criterion.
European Licensure (CHMP) criterion is met if the percentage of subjects achieving (at day 43) HI titers ≥40 is >70%."|Day 1, day 22, day 43 and day 387|Analysis was done on the FAS set.||Percentages of subjects||95% Confidence Interval|Number
665141|NCT01776541|Secondary|Geometric Mean Ratios Against A/H5N1 Strain Following 2-dose Vaccination Schedule of Either Low Dose or High Dose aH5N1c Vaccine.|"Immunogenicity was measured as the geometric mean ratio (GMR). The ratio of postvaccination to prevaccination HI GMTs, 3 weeks after first vaccination, 3 weeks after second vaccination and 12 months after second vaccination of either low dose or high dose of aH5N1c is reported.
The criterion is met according to the European Committee for Medicinal Products for Human Use (CHMP) criterion if the geometric mean increase GMR (day 43/day 1) in HI antibody titer is >2.5 for subjects 18-60 years of age."|Day 1; day 22; day 43 and day 387|Analysis was done on the FAS set.||Ratio||95% Confidence Interval|Geometric Mean
665142|NCT01776541|Primary|Number of Subjects Reporting Unsolicited AEs After Any Vaccination.|Safety was assessed using the number of subjects who reported any unsolicited adverse events, adverse events possibly or probably related to study vaccine, serious adverse events (SAEs), new onset of chronic diseases (NOCDs), medically attended AEs, AEs of special interest (AESIs), AEs leading to withdrawal from study following vaccination with either low or high dose of aH5N1c vaccine.|Any unsolicited AEs - day 1 through day 22 after any vaccination. SAEs, NOCDs. medically attended AEs, AESIs, AEs leading to study withdrawal- day 1 to day 387|Analysis was done on the safety dataset, i.e. the subjects in the exposed population who provided postvaccination safety data.||Number of subjects|||Number
665143|NCT01776541|Primary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AE), After Any Vaccination.|Safety was assessed using the number of subjects who reported solicited local and systemic AEs following vaccination with either low or high dose of aH5N1c vaccine.|From day 1 through day 7 after any vaccination.|Analysis was done on the safety dataset, i.e. the subjects in the exposed population who provided postvaccination safety data.||Number of subjects|||Number
665144|NCT01776541|Primary|Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain.|"Immunogenicity was measured in terms of the percentages of subjects achieving seroconversion or significant increase in HI titer against the vaccine strain, three weeks after receiving two injections of low dose or high dose of aH5N1c vaccine according to the CBER criterion.
Seroconversion is defined as either a) in subjects with a prevaccination HI titer <10, a postvaccination titer ≥40; or b) in subjects with prevaccination HI titer ≥10, a minimum four-fold rise in postvaccination HI antibody titer.
CBER criterion for the adult population is met if the lower limit of the two-sided 95% CI for the percentages of subjects achieving seroconversion for HI antibody titer meets or exceeds 40%."|Three weeks after 2nd vaccination (day 43)|This analysis was done on the FAS population.||Percentages of subjects||95% Confidence Interval|Number
665145|NCT01776541|Primary|Percentages Of Subjects Achieving Hemagglutinin Inhibition (HI) Titers ≥40 Against A/H5N1 Strain.|"The optimal aH5N1c vaccine formulation was evaluated in terms of percentages of subjects achieving HI titers ≥40 against homologous A/H5N1 strain, three weeks after second vaccination with either low dose or high dose of aH5N1c vaccine, according to the Center for Biologics Evaluation and Research (CBER) criterion.
CBER criterion for the adult population is met if the lower limit of the two-sided 95% confidence interval (CI) for the percentages of subjects achieving HI titer ≥40 meets or exceeds 70%."|Three weeks after 2nd vaccination (day 43)|Analysis was done on the Full Analysis Set (FAS) i.e., the subjects who actually receive at least one dose of study vaccination and provide at least one evaluable serum sample both before (baseline) and after vaccination.||Percentages of subjects||95% Confidence Interval|Number
665146|NCT01776268|Primary|Concentration of APPs After Oral Priming|Saliva will be sampled 24-48 hours after the 5-days of oral priming is completed. Investigators are assessing saliva for a change in the concentration of antimicrobial proteins.|days 7-9 of life|||femtomole (fmol)||Inter-Quartile Range|Mean
665147|NCT01776268|Primary|Concentration of APPs Before Oral Priming|Saliva will be sampled on day 1-2 of life prior to oral priming. Investigators are assessing saliva for a change in the concentration of antimicrobial proteins.|days 1-2 of life|||femtomole (fmol)||Inter-Quartile Range|Mean
665148|NCT01775995|Other Pre-specified|Pain Sensitivity to Experimental Thermal Stimuli|Pain sensitivity to thermal stimuli was assessed using standard psychophysical procedures. Thermal stimuli, ranging from 43 to 49oC, were applied to the thenar eminence of the right hand. Each stimulus was rated on two separate, validated 0-20 category-ratio scales assessing pain intensity and unpleasantness.|0, 8, 26 weeks||||||
665149|NCT01775995|Other Pre-specified|Economic Outcomes|"Cost of medications, health care utilization, motor vehicle accidents (MVAs), and lost productivity were assessed.
Medications (past month - self-report, verified against medication bottles): opioids (Timeline Followback), other medications (average daily use); costs for the past 6 months were calculated. Health care utilization (past 6 months): self-reported number of outpatient (medical, mental health, urgent care) and emergency department visits; number of inpatient days. Lost productivity (past 6 months): self-report number of missed work and leisure days. MVAs (past 6 months): self-report number of MVAs.
Cost Sources: Medications - rxpricequotes.com (primary), drugs.com (secondary), walgreens.com (tertiary). Health care utilization - WI Price Point System, Medical Expenditure Panel Survey. MVAs - National Safety Council. Lost productivity - U.S. Dept of Labor (average daily wage for a WI worker for work days; 8-hours of the federal minimum wage for lost leisure day)."|From enrollment to 26 week follow-up (6 months)|One meditation-CBT participant did not provide data at 8-week follow-up; two participants (one meditation-CBT, one control) did not provide data at 26-week follow-up. All 35 participants were included in the analysis; missing participant data was imputed based on existing data for the given participant.||dollars||Standard Deviation|Mean
665150|NCT01775995|Other Pre-specified|Economic Outcomes|"Cost of medications, health care utilization, motor vehicle accidents (MVAs), and lost productivity were assessed.
Medications (past month - self-report, verified against medication bottles): opioids (Timeline Followback), other medications (average daily use); costs for the past 6 months were calculated. Health care utilization (past 6 months): self-reported number of outpatient (medical, mental health, urgent care) and emergency department visits; number of inpatient days. Lost productivity (past 6 months): self-report number of missed work and leisure days. MVAs (past 6 months): self-report number of MVAs.
Cost Sources: Medications - rxpricequotes.com (primary), drugs.com (secondary), walgreens.com (tertiary). Health care utilization - WI Price Point System, Medical Expenditure Panel Survey. MVAs - National Safety Council. Lost productivity - U.S. Dept of Labor (average daily wage for a WI worker for work days; 8-hours of the federal minimum wage for lost leisure day)."|6 months prior to baseline, to baseline (enrollment)|||dollars||Standard Deviation|Mean
665151|NCT01775995|Other Pre-specified|C-Reactive Protein|"Serum levels of C-reactive protein were used to assess the potential biological effects of the intervention. Normal values for C-reactive protein fall between 0 and 1 mg/dL; higher levels may indicate inflammatory or infectious processes.
This outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure)."|baseline to 26 weeks|Six Meditation-CBT participants and one Wait-list Control participant did not provide biological data at 26 week follow-up. Results for this measure are based on the number of participants analyzed.||mg/dL||95% Confidence Interval|Mean
665152|NCT01775995|Other Pre-specified|C-Reactive Protein|"Serum levels of C-reactive protein were used to assess the potential biological effects of the intervention. Normal values for C-reactive protein fall between 0 and 1 mg/dL; higher levels may indicate inflammatory or infectious processes.
This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure)."|baseline to 8 weeks|Three Meditation-CBT participants did not provide biological data at 8 week follow-up. Results for this measure are based on the number of participants analyzed.||mg/dL||95% Confidence Interval|Mean
665153|NCT01775995|Other Pre-specified|Emotion Regulation Difficulty|"Emotion regulation difficulty was assessed using the 36-item Difficulties in Emotion Regulation Scale (DERS). This measure's total score (36-180) reflects the severity of emotion regulation difficulty (no timeframe specified).
This outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased emotion regulation difficulty and negative values indicating decreased emotion regulation difficulty."|baseline to 26 weeks|One Meditation-CBT and one Wait-list Control participant did not provide data for this measure at 26-week follow up. Results on this measure are based on the number of participants analyzed.||units on a scale||95% Confidence Interval|Mean
665154|NCT01775995|Other Pre-specified|Emotion Regulation Difficulty|"Emotion regulation difficulty was assessed using the 36-item Difficulties in Emotion Regulation Scale (DERS). This measure's total score (36-180) reflects the severity of emotion regulation difficulty (no timeframe specified).
This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased emotion regulation difficulty and negative values indicating decreased emotion regulation difficulty."|baseline to 8 weeks|One Meditation-CBT participant did not provide data for this measure at 8-week follow up. Results on this measure are based on the number of participants analyzed.||units on a scale||95% Confidence Interval|Mean
665155|NCT01775995|Other Pre-specified|Anxiety Symptom Severity|"Anxiety symptom severity was assessed using the anxiety subscale of the 90-item Symptom Checklist - Revised (SCL-90-R). This measure's 10-item Anxiety subscale (0-40) reflects the degree of severity of distress from anxiety symptoms during the past 7 days.
This outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased levels of distress from anxiety symptoms and negative values indicating decreased levels of distress from anxiety symptoms."|baseline to 26 weeks|One Meditation-CBT and one Wait-list Control participant did not provide data for this measure at 26-week follow up. Results on this measure are based on the number of participants analyzed.||units on a scale||95% Confidence Interval|Mean
665156|NCT01775995|Other Pre-specified|Anxiety Symptom Severity|"Anxiety symptom severity was assessed using the anxiety subscale of the 90-item Symptom Checklist - Revised (SCL-90-R). This measure's 10-item Anxiety subscale (0-40) reflects the degree of severity of distress from anxiety symptoms during the past 7 days.
This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased levels of distress from anxiety symptoms and negative values indicating decreased levels of distress from anxiety symptoms."|baseline to 8 weeks|One Meditation-CBT participant did not provide data for this measure at 8-week follow up. Results on this measure are based on the number of participants analyzed.||units on a scale||95% Confidence Interval|Mean
665198|NCT01775670|Primary|Disabilities of the Arm, Shoulder and Hand Quick Questionnaire (Quick-DASH)|The short form of the Disabilities of Arm Shoulder and Hand to assess upper extremity disability. The scale range is from 0-100, where 0 is no difficulty performing tasks and 100 is the most difficulty or unable to complete any tasks.|At enrollment|||units on a scale||Standard Deviation|Mean
666094|NCT01763827|Primary|Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
665157|NCT01775995|Other Pre-specified|Depression Symptom Severity|"Depression symptom severity was assessed using the depression subscale of the 90-item Symptom Checklist - Revised (SCL-90-R). This measure's 13-item Depression subscale (0-52) reflects the degree of severity of distress from depression symptoms during the past 7 days.
This outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased levels of distress from depression symptoms and negative values indicating decreased levels of distress from depression symptoms."|baseline to 26 weeks|One Meditation-CBT and one Wait-list Control participant did not provide data for this measure at 26-week follow up. Results on this measure are based on the number of participants analyzed.||units on a scale||95% Confidence Interval|Mean
665158|NCT01775995|Other Pre-specified|Depression Symptom Severity|"Depression symptom severity was assessed using the depression subscale of the 90-item Symptom Checklist - Revised (SCL-90-R). This measure's 13-item Depression subscale (0-52) reflects the degree of severity of distress from depression symptoms during the past 7 days.
This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased levels of distress from depression symptoms and negative values indicating decreased levels of distress from depression symptoms."|baseline to 8 weeks|One Meditation-CBT participant did not provide data for this measure at 8-week follow up. Results on this measure are based on the number of participants analyzed.||units on a scale||95% Confidence Interval|Mean
665159|NCT01775995|Other Pre-specified|Mental Health Symptom Severity|"Mental Health Symptom Severity was assessed using the 90-item Symptom Checklist - Revised (SCL-90-R). This measure's Global Severity Index (i.e. total score, 0-360) reflects the degree of severity of mental health symptom distress during the past 7 days.
This outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased levels of mental health symptom distress and negative values indicating decreased mental health symptom distress."|baseline to 26 weeks|One Meditation-CBT and one Wait-list Control participant did not provide data for this measure at 26-week follow up. Results on this measure are based on the number of participants analyzed.||units on a scale||95% Confidence Interval|Mean
665160|NCT01775995|Other Pre-specified|Mental Health Symptom Severity|"Mental Health Symptom Severity was assessed using the 90-item Symptom Checklist - Revised (SCL-90-R). This measure's Global Severity Index (i.e. total score, 0-360) reflects the degree of severity of mental health symptom distress during the past 7 days.
This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased levels of mental health symptom distress and negative values indicating decreased mental health symptom distress."|baseline to 8 weeks|One Meditation-CBT participant did not provide data for this measure at 8-week follow up. Results on this measure are based on the number of participants analyzed.||units on a scale||95% Confidence Interval|Mean
665161|NCT01775995|Other Pre-specified|Perceived Stress|"Perceived stress was assessed using the 10-item Perceived Stress Scale (PSS-10). This measure's total score (0-40) reflects the degree to which one perceives their life experiences as stressful in the last month.
This outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased perceived stress and negative values indicating decreased perceived stress."|baseline to 26 weeks|One Meditation-CBT and one Wait-list Control participant did not provide data for this measure at 26-week follow up. Results on this measure are based on the number of participants analyzed.||units on a scale||95% Confidence Interval|Mean
665162|NCT01775995|Other Pre-specified|Perceived Stress|"Perceived stress was assessed using the 10-item Perceived Stress Scale (PSS-10). This measure's total score (0-40) reflects the degree to which one perceives their life experiences as stressful in the last month.
This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased perceived stress and negative values indicating decreased perceived stress."|baseline to 8 weeks|One Meditation-CBT participant did not provide data for this measure at 8-week follow up. Results on this measure are based on the number of participants analyzed.||units on a scale||95% Confidence Interval|Mean
665163|NCT01775995|Other Pre-specified|Chronic Pain Acceptance|"Pain acceptance was assessed using the 20-item Chronic Pain Acceptance Questionnaire (CPAQ). This measure's total score (0-120) reflects one's degree of acceptance of their chronic pain, not specifying a time frame.
This outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased chronic pain acceptance and negative values indicating decreased chronic pain acceptance."|baseline to 26 weeks|One Meditation-CBT and one Wait-list Control participant did not provide data for this measure at 26-week follow up. Results on this measure are based on the number of participants analyzed.||units on a scale||95% Confidence Interval|Mean
665164|NCT01775995|Other Pre-specified|Chronic Pain Acceptance|"Pain acceptance was assessed using the 20-item Chronic Pain Acceptance Questionnaire (CPAQ). This measure's total score (0-120) reflects one's degree of acceptance of their chronic pain, not specifying a time frame.
This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased chronic pain acceptance and negative values indicating decreased chronic pain acceptance."|baseline to 8 weeks|One Meditation-CBT participant did not provide data for this measure at 8-week follow up. Results on this measure are based on the number of participants analyzed.||units on a scale||95% Confidence Interval|Mean
665165|NCT01775995|Other Pre-specified|Drug Use|Percentage of participants endorsing drug use during the past 28 days was assessed using the Timeline Follow-Back Method.|26 weeks|One Meditation-CBT and one Wait-list Control participant did not provide data for this measure at 26 week follow-up. Results for this measure are based on the number of participants analyzed.||percentage using drugs|||Number
665166|NCT01775995|Other Pre-specified|Drug Use|Percentage of participants endorsing drug use during the past 28 days was assessed using the Timeline Follow-Back Method.|8 weeks|One Meditation-CBT participant did not provide data for this measure at 8 week follow-up. Results for this measure are based on the number of participants analyzed.||percentage using drugs|||Number
665167|NCT01775995|Other Pre-specified|Drug Use|Percentage of participants endorsing drug use during the past 28 days was assessed using the Timeline Follow-Back Method.|Baseline|||percentage using drugs|||Number
666048|NCT01763905|Secondary|Percentage of Participants With Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL (1.8 mmol/L)||Weeks 10 and 12|Full analysis set||percentage of participants||95% Confidence Interval|Number
665171|NCT01775995|Secondary|Opioid Dose|"Daily opioid dose was assessed using the Timeline Followback Method which looked at the past 28 days of opioid use. Medication use reports were verified against the medication bottles. Daily opioid dose was standardized [daily morphine-equivalent dose (MED)] across different opioids for each participant.
This outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased daily opioid dose and negative values indicating decreased daily opioid dose."|baseline to 26 weeks|One Meditation-CBT and one Wait-list Control participant did not provide data for this measure at 26-week follow up. Results on this measure are based on the number of participants analyzed.||morphine-equivalent mg/day||95% Confidence Interval|Mean
665172|NCT01775995|Secondary|Opioid Dose|"Daily opioid dose was assessed using the Timeline Followback Method which looked at the past 28 days of opioid use. Medication use reports were verified against the medication bottles. Daily opioid dose was standardized [daily morphine-equivalent dose (MED)] across different opioids for each participant.
This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased daily opioid dose and negative values indicating decreased daily opioid dose."|baseline to 8 weeks|One Meditation-CBT participant did not provide data for this measure at 8-week follow up. Results on this measure are based on the number of participants analyzed.||morphine-equivalent mg/day||95% Confidence Interval|Mean
665173|NCT01775995|Primary|Health-Related Quality of Life: Physical Function|"Physical function was assessed using the 10-item Oswestry Disability Index (ODI). This measure's total score (0-100) reflects the percent of chronic low back pain related disability today.
This outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased disability and negative values indicating decreased disability."|baseline to 26 weeks|One Meditation-CBT and one Wait-list Control participant did not provide data for this measure at 26-week follow up. Results on this measure are based on the number of participants analyzed.||percentage disability||95% Confidence Interval|Mean
665174|NCT01775995|Primary|Health-Related Quality of Life: Physical Function|"Physical function was assessed using the 10-item Oswestry Disability Index (ODI). This measure's total score (0-100) reflects the percent of chronic low back pain related disability today.
This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased disability and negative values indicating decreased disability."|baseline to 8 weeks|One Meditation-CBT participant did not provide data for this measure at 8-week follow up. Results on this measure are based on the number of participants analyzed.||percentage disability||95% Confidence Interval|Mean
665175|NCT01775995|Primary|Health-Related Quality of Life: Averaged Pain Severity|"Averaged pain is the average of 4 responses on a 0-10 numerical rating scale (0=no pain; 10=worst possible pain) from the Brief Pain Inventory (BPI): 1) describe your pain at its worst in the last week 2) describe your pain at its least in the last week 3) describe your pain on the average 4) describe your pain right now.
This outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased pain and negative values indicating decreased pain."|baseline to 26 weeks|One Meditation-CBT and one Wait-list Control participant did not provide data for this measure at 26-week follow up. Results on this measure are based on the number of participants analyzed.||units on a scale||95% Confidence Interval|Mean
665176|NCT01775995|Primary|Health-Related Quality of Life: Averaged Pain Severity|"Averaged pain is the average of 4 responses on a 0-10 numerical rating scale (0=no pain; 10=worst possible pain) from the Brief Pain Inventory (BPI): 1) describe your pain at its worst in the last week 2) describe your pain at its least in the last week 3) describe your pain on the average 4) describe your pain right now.
This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased pain and negative values indicating decreased pain."|baseline to 8 weeks|One Meditation-CBT participant did not provide data for this measure at 8-week follow up. Results on this measure are based on the number of participants analyzed.||units on a scale||95% Confidence Interval|Mean
665177|NCT01775852|Secondary|Mean Change of World Health Organization Disability Assessment (WHO-DAS) From Baseline to 12-week Follow up.|"The WHODAS contains 36 items on functioning and disability with a recall period of 30 days covering 7 domains: Understanding and Communicating (6 items), Getting around (5 items), Self-care (4 items), Getting along with others (5 items), Life activities: household (4 items), Life activities: work/school (4 items), and Participation in society (8 items). Response options go from 1 (no difficulty) to 5 (extreme difficulty or can not do).
WHODAS domain scores are computed for each domain by adding the item responses together. A global score is then computed by summing all domains together, and transforming them into a range from 0 to 100, with higher scores indicating higher levels of disability (0= no disability, 100= full disability)."|Change at 12 week follow-up from baseline|||units on a scale||Standard Error|Mean
665178|NCT01775852|Secondary|Mean Change on Short Form Health Survey (SF-36) From Baseline to 12 Week Follow-up.|"The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health.
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability."|Change at 12 week follow-up from baseline|||units on a scale||Standard Error|Mean
665179|NCT01775852|Secondary|Mean Change Score in HDI (Headache Disability Inventory) From Baseline to 12 Weeks.|"The HDI is useful in assessing the impact of headache, and its treatment, on daily living. 25 self-report items are rated with answers as Yes (4 points), Sometimes (2 Points), and No (0 points). All items are then added together to create an overall score which can range from 0 (no impact), to 100 (severe impact) of headache on daily life.
A 29 point change (95% confidence interval) or greater in the total score from test to retest must occur before the change can be attributed to treatment effects."|12 week change from baseline|||units on a scale||Standard Error|Mean
665199|NCT01775553|Secondary|Markers of ER Stress|The markers of ER stress signaling (both apoptotic and prosurvival) in MM cells from patients in this study and to determine if the balance of apoptotic versus prosurvival signaling changes upon recapture of response with carfilzomib dose escalation relative to the time of study entry.|up to 4 years|data not collected|||||
665200|NCT01775553|Secondary|Duration of Response to High Dose Carfilzomib||up to 4 years|||months||Full Range|Median
665180|NCT01775852|Primary|Mean Change in Hamilton Depression Rating Scale (HAM-D) From Baseline to 12 Week Follow-up|"The HAM-D is a structured clinical interview for assessing depression severity. Outcome measure will be change from Baseline in Hamilton Depression Rating Scale at 12 week (3 month) follow-up from baseline.
Measure is scored by adding individual items and attaining an overall severity score. Scores range from 0 to 53, with higher values signifying a higher level of depression severity (and thus a worse outcome). A score of 0–7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher (indicating at least moderate severity) is usually required for entry into a clinical trial."|12 week change from baseline|||units on a scale||Standard Error|Mean
665181|NCT01775774|Secondary|Mortality at Hospital Discharge|The number of patients expired at hospital discharge.|From study enrollment to Hospital discharge|||participants|||Number
665182|NCT01775774|Secondary|Hospital Survival to Day 60|The number of subjects alive at study day 60. Those subjects discharged home prior to day 60 were counted as alive at day 60.|60 days after randomization|||participants|||Number
665183|NCT01775774|Secondary|ICU Free Days to Day 28||28 days after study enrollment|||day||Full Range|Median
665184|NCT01775774|Secondary|Duration of Vasopressor Use (Days)|Days on vasopressor to day 28 after study enrollment|28 days|||day||Full Range|Median
665185|NCT01775774|Secondary|Ventilator Free Days at Study Day 28|Ventilator Free Days (VFDs) to day 28 were defined as the number of days from the time of initiating unassisted breathing to day 28 after randomization, assuming survival for at least two consecutive calendar days after initiating unassisted breathing and continued unassisted breathing to day 28. If a subject received assisted breathing at day 27 or died prior to day 28, a value of zero VFDs was given.|time of initiating unassisted breathing to day 28|||day||Full Range|Median
665186|NCT01775774|Secondary|Incidence of Severe Adverse Events (SAEs)|The number of participants with a severe adverse event during the study was assessed.|Investigators conducted daily assessments for the presence of adverse events (AE) from enrollment through study day 28 or hospital discharge, whichever occurred first.|||participants|||Number
665187|NCT01775774|Primary|Incidence of Pre-specified Infusion Associated Adverse Events|"Any of the following occurring within 6 h of mesenchymal stem-cell infusion:
Addition of a third vasopressor or an increase in vasopressor dose greater than or equal to the following:
Norepinephrine: 10 μg per min
Phenylephrine: 100 μg per min
Dopamine: 10 μg/kg per min
Epinephrine: 0·1 μg/kg per min
Hypoxaemia requiring an increase in the fraction of inspired oxygen of ≥0·2 and increase in positive end-expiratory airway pressure level of 5 cm H2O or more to maintain transcutaneous oxygen saturations in the target range of 88–95%
New cardiac arrhythmia requiring cardioversion
New ventricular tachycardia, ventricular fi brillation, or asystole
A clinical scenario consistent with transfusion incompatibility or transfusion-related infection
Cardiac arrest or death within 24 h of mesenchymal stem-cell infusion"|24 hours|||participants|||Number
665188|NCT01775670|Primary|Average Pain 2 Months After Enrollment|Average pain will be assessed 2 months after enrollment. 11-point ordinal pain scale to assess the amount of pain. The scale range for pain is from 0-10, where 0 is no pain and 10 is the worst pain.|At 2 months after enrollment|Subjects did not complete the pain scale questionnaire at the follow up visit.|||||
665189|NCT01775670|Secondary|Thumb Grip Strength|Grip strength of the affected hand was measured at enrollment using a dynamometer. The subject squeezes the handle of the dynamometer to maximum capability to measure grip strength. Each subject completed the grip strength measurement 3 times on the affected hand to get an average grip strength of the affected hand.|At Enrollment|||pounds||Standard Deviation|Mean
665190|NCT01775670|Secondary|Thumb Pinch Strength|Measurement of thumb pinch strength using a pinch meter. Subjects place the pinch meter between their thumb and index finger and pinch down to record the pinch strength.|At Enrollment|||pounds||Standard Deviation|Mean
665191|NCT01775670|Secondary|Thumb MCP in Pinch Position (Degrees)|Measurements of thumb MCP in pinch position.|At Enrollment|The measurement of the thumb MCP joint in a pinch position was the same, 10 degrees, for the 2 subjects in the OT splint group, therefore the standard deviation is 0.||degrees||Standard Deviation|Mean
665192|NCT01775670|Secondary|Thumb Metacarpophalangeal (MCP) Joint in Resting Position (Degrees)|Measurements of thumb metacarpophalangeal (MCP) joint in resting position.|At Enrollment|||degrees||Standard Deviation|Mean
665193|NCT01775670|Secondary|PROMIS Pain – Interference|A computerized assessment of pain interference measured at enrollment. The average T score of the U.S. population is 50, so the T score reported compares the study population to the U.S. population, where a T score greater than 50 is worse than the average and a T score less than 50 is better than the average.|At Enrollment|||T score||Standard Deviation|Mean
665194|NCT01775670|Secondary|Patient Reported Outcomes Measurement Information System (PROMIS) – Depression|A computerized assessment of depression measured at enrollment. The average T score of the U.S. population is 50, so the T score reported compares the study population to the U.S. population, where a T score greater than 50 is worse than the average and a T score less than 50 is better than the average.|At Enrollment|The data was not recorded for the 1 patient randomized to the off-the-shelf group.||T score||Standard Deviation|Mean
665195|NCT01775670|Primary|Average Satisfaction With the Splint 2 Months After Enrollment|Average satisfaction with splint treatment will be assessed 2 months after enrollment. 11-point ordinal pain scale to assess the amount of satisfaction. The scale range for satisfaction is from 0-10, where 0 is dissatisfaction and 10 is complete satisfaction with the splint.|At 2 months after enrollment|||units on a scale||Standard Deviation|Mean
665196|NCT01775670|Primary|Thumb Pain at Enrollment|11-point ordinal pain scale to assess the amount of pain. The scale range is from 0-10, where 0 is no pain at all and 10 is the worst pain ever had.|At enrollment|||units on a scale||Standard Deviation|Mean
665197|NCT01775670|Primary|Change From the Baseline in the Disabilities of the Arm, Shoulder and Hand Quick Questionnaire (Quick-DASH) at 2 Months After Enrollment|The short form of the Disabilities of Arm Shoulder and Hand to assess upper extremity disability. The scale range is from 0-100, where 0 is no difficulty performing tasks and 100 is the most difficulty or unable to complete any tasks. This was measured 2-month after treatment.|2 months after enrollment|The one subject in the off-the-shelf group was lost to follow up.||units on a scale||Standard Deviation|Mean
665201|NCT01775553|Secondary|Overall Response Rate (ORR)|Overall Response Rate defined in categories|up to 4 years|||Participants|||Count of Participants
665202|NCT01775553|Secondary|Progression Free Survival (PFS)||up to 4 years|||months||Full Range|Median
665204|NCT01775189|Other Pre-specified|Number of Participants With Clinically Significant Change in Oxygen Saturation of Hemoglobin (SpO2)|Oxygen saturation of hemoglobin in blood (SpO2) was monitored using pulse oximetry continuously for 5 hours following dosing in the drug discrimination phase and continuously for 12 hours following dosing in the treatment phase, or longer at the discretion of the investigator. Individual measurement was collected in a sitting position. If SpO2 fall below 90 percent (%), the investigator administered oxygen via nasal cannula at a flow rate sufficient to maintain the SpO2 greater than or equal to 90%. Participants with fall in SpO2 below 90% were reported.|Drug discrimination phase: pre-dose up to 5 hours; intervention period: pre-dose up to 12 hours|Safety analysis set included all participants who received at least 1 dose of study drug, beginning with the naloxone challenge phase.||participants|||Number
665205|NCT01775189|Other Pre-specified|Number of Participants With Clinically Significant Change in End Tidal Carbon Dioxide (EtCO2)|End-tidal carbon dioxide concentration in the expired air (EtCO2) was monitored using capnography in a sitting position. Criteria for clinically significant change in EtCO2 was based on investigator’s discretion.|Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Safety analysis set included all participants who received at least 1 dose of study drug, beginning with the naloxone challenge phase.||participants|||Number
665206|NCT01775189|Other Pre-specified|Number of Participants With Clinically Significant Change in Vital Sign Examinations|Vital signs assessment included measurement of heart rate, systolic and diastolic blood pressures, and respiratory rate. Criteria for clinically significant change in any vital sign examination was based on investigator’s discretion.|Screening up to 3 to 7 days following last study drug administration, or time of early withdrawal|Safety analysis set included all participants who received at least 1 dose of study drug, beginning with the naloxone challenge phase.||participants|||Number
665207|NCT01775189|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 3 - 7 days following last study drug administration that were absent before treatment or that worsened relative to pre-treatment state. Symptoms of withdrawal following naloxone administration (naloxone challenge phase) were not collected as adverse events unless they met the criteria for an SAE. AEs included SAEs as well as non-serious AEs which occurred during the trial.|Screening up to 3 to 7 days following last study drug administration, or time of early withdrawal|Safety analysis set included all participants who received at least 1 dose of study drug, beginning with the naloxone challenge phase.||participants|||Number
665208|NCT01775189|Other Pre-specified|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Naltrexone and 6-beta-naltrexol|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). Participants who received ALO-02 were reported. 6-Beta-naltrexol is metabolites of naltrexone.|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Parameter analysis set included all enrolled participants who received at least 1 dose of study drug and who had at least 1 of the PK parameters of interest. Here ‘n’ signifies those participants who were evaluable for specified category.||nanogram*hour/milliliter (ng*hr/mL)||Standard Deviation|Mean
665209|NCT01775189|Other Pre-specified|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Naltrexone and 6-beta-naltrexol|Area under the plasma concentration time-curve from zero to the last quantifiable concentration (AUClast). Participants who received ALO-02 were reported. 6-Beta-naltrexol is metabolites of naltrexone.|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Parameter analysis set included all enrolled participants who received at least 1 dose of study drug and who had at least 1 of the PK parameters of interest.||nanogram*hour/milliliter (ng*hr/mL)||Standard Deviation|Mean
665210|NCT01775189|Other Pre-specified|Area Under the Concentration-Time Curve (AUC) From 0-1 Hour, 0-2 Hour and 0-8 Hour of Naltrexone and 6-beta-naltrexol|AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. Participants who received ALO-02 were reported. 6-Beta-naltrexol is metabolites of naltrexone.|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8 hours post-dose|Parameter analysis set included all enrolled participants who received at least 1 dose of study drug and who had at least 1 of the PK parameters of interest.||nanogram*hour/milliliter (ng*hr/mL)||Standard Deviation|Mean
665211|NCT01775189|Other Pre-specified|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Oxycodone, Oxymorphone and Noroxycodone|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). Participants who received oxycodone and ALO-02 were reported. Oxymorphone and noroxycodone are metabolites of oxycodone.|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Parameter analysis set included all enrolled participants who received at least 1 dose of study drug and who had at least 1 of the PK parameters of interest. Here ‘n’ signifies participants evaluable for specified category for each arm, respectively.||nanogram*hour/milliliter (ng*hr/mL)||Standard Deviation|Mean
665212|NCT01775189|Other Pre-specified|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Oxycodone, Oxymorphone and Noroxycodone|Area under the plasma concentration time-curve from zero to the last quantifiable concentration (AUClast). Participants who received oxycodone and ALO-02 were reported. Oxymorphone and noroxycodone are metabolites of oxycodone.|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Parameter analysis set included all enrolled participants who received at least 1 dose of study drug and who had at least 1 of the PK parameters of interest.||nanogram*hour/milliliter (ng*hr/mL)||Standard Deviation|Mean
665268|NCT01775137|Secondary|Percentage of Participants Who Used New Anti-pseudomonal Antibiotics in Extension Study|The rate of anti-pseudomonal antibiotics use were determined from the collection of concomitant medication during the study.|Baseline of extension study, Day 673 (end of extension study)|The analysis was performed in extension safety population.||Percentage of participants|||Number
665213|NCT01775189|Other Pre-specified|Area Under the Concentration-Time Curve (AUC) From 0-1 Hour, 0-2 Hour and 0-8 Hour of Oxycodone, Oxymorphone and Noroxycodone|AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. Participants who received oxycodone and ALO-02 were reported. Oxymorphone and noroxycodone are metabolites of oxycodone.|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8 hours post-dose|Parameter analysis set included all enrolled participants who received at least 1 dose of study drug and who had at least 1 of the PK parameters of interest.||nanogram*hour/milliliter (ng*hr/mL)||Standard Deviation|Mean
665214|NCT01775189|Other Pre-specified|Plasma Decay Half-Life (t1/2) of Naltrexone and 6-beta-naltrexol|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Participants who received ALO-02 were reported. 6-Beta-naltrexol is metabolites of naltrexone.|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Parameter analysis set included all enrolled participants who received at least 1 dose of study drug and who had at least 1 of the PK parameters of interest. Here ‘n’ signifies those participants who were evaluable for specified category.||hours||Standard Deviation|Mean
665215|NCT01775189|Other Pre-specified|Plasma Decay Half-Life (t1/2) of Oxycodone, Oxymorphone and Noroxycodone|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Participants who received oxycodone and ALO-02 were reported. Oxymorphone and noroxycodone are metabolites of oxycodone.|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Parameter analysis set included all enrolled participants who received at least 1 dose of study drug and who had at least 1 of the PK parameters of interest. Here ‘n’ signifies participants evaluable for specified category for each arm, respectively.||hours||Standard Deviation|Mean
665216|NCT01775189|Other Pre-specified|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Naltrexone and 6-beta-naltrexol|Participants who received ALO-02 were reported. 6-Beta-naltrexol is metabolites of naltrexone.|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Parameter analysis set included all enrolled participants who received at least 1 dose of study drug and who had at least 1 of the PK parameters of interest.||hours||Full Range|Median
665217|NCT01775189|Other Pre-specified|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Oxycodone, Oxymorphone and Noroxycodone|Participants who received oxycodone and ALO-02 were reported. Oxymorphone and noroxycodone are metabolites of oxycodone.|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Parameter analysis set included all enrolled participants who received at least 1 dose of study drug and who had at least 1 of the PK parameters of interest. Here ‘n’ signifies participants evaluable for specified category for each arm, respectively.||hours||Full Range|Median
665218|NCT01775189|Other Pre-specified|Maximum Observed Plasma Concentration (Cmax) of Naltrexone and 6-beta-naltrexol|Participants who received ALO-02 were reported. 6-Beta-naltrexol is metabolites of naltrexone.|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Parameter analysis set included all enrolled participants who received at least 1 dose of study drug and who had at least 1 of the PK parameters of interest.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
665219|NCT01775189|Other Pre-specified|Maximum Observed Plasma Concentration (Cmax) of Oxycodone, Oxymorphone and Noroxycodone|Participants who received oxycodone and ALO-02 were reported. Oxymorphone and noroxycodone are metabolites of oxycodone.|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Parameter analysis set included all enrolled participants who received at least 1 dose of study drug and who had at least 1 of the pharmacokinetic (PK) parameters of interest.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
665220|NCT01775189|Other Pre-specified|Subject Rating Scale for Nasal Effects: Time to Maximum (Peak) Effect (TEmax)|Participant-rated scale for nasal effects was used to assess burning, need to blow nose, runny nose/nasal discharge, facial pain/pressure, and nasal congestion using a 6-point scale (where, 0 = not present/no problem; 1 = very mild problem; 2 = mild/slight problem; 3 = moderate problem; 4 = severe problem; 5 = problem “as bad as can be”). TEmax = Time to maximum observed score.|Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2 hours post-dose|Safety analysis set included all participants who received at least 1 dose of study drug, beginning with the naloxone challenge phase.||hours||Full Range|Median
665221|NCT01775189|Other Pre-specified|Subject Rating Scale for Nasal Effects: Area Under Effect Curve (AUE) From 0-1 Hour and 0-2 Hour|Participant-rated scale for nasal effects was used to assess burning, need to blow nose, runny nose/nasal discharge, facial pain/pressure, and nasal congestion using a 6-point scale (where, 0 = not present/no problem; 1 = very mild problem; 2 = mild/slight problem; 3 = moderate problem; 4 = severe problem; 5 = problem “as bad as can be”). AUE (0-x) = Area under the effect versus time curve from time 0 to x hours (0-x).|Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2 hours post-dose|Safety analysis set included all participants who received at least 1 dose of study drug, beginning with the naloxone challenge phase.||units on a scale*hours||Standard Deviation|Mean
665222|NCT01775189|Other Pre-specified|Subject Rating Scale for Nasal Effects: Peak Effect (Emax)|Participant-rated scale for nasal effects was used to assess burning, need to blow nose, runny nose/nasal discharge, facial pain/pressure, and nasal congestion using a 6-point scale (where, 0 = not present/no problem; 1 = very mild problem; 2 = mild/slight problem; 3 = moderate problem; 4 = severe problem; 5 = problem “as bad as can be”). Emax = Maximum observed score.|Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2 hours post-dose|Safety analysis set included all participants who received at least 1 dose of study drug, beginning with the naloxone challenge phase.||units on a scale||Standard Deviation|Mean
665223|NCT01775189|Other Pre-specified|High: Time to Maximum (Peak) Effect (TEmax)|High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.||hours||Full Range|Median
665344|NCT01774097|Primary|Peak Hyperemic Popliteal Flow (Phase Contrast MRA)|The placebo adjusted average change in peak hyperemic popliteal flow (mL/s) over time.|Assessed at baseline and 6 months|Participants who had available analyzable baseline and 6 month MRI imaging||ml/sec||Standard Deviation|Mean
666049|NCT01763905|Secondary|Change From Baseline in LDL-C at Week 12||Baseline and Week 12|Full analysis set||mg/dL||Standard Error|Least Squares Mean
665224|NCT01775189|Other Pre-specified|High: Area Under Effect Curve (AUE) From 0-1 Hour, 0-8 Hour and 0-24 Hours|High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time 0 to x hours (0-x).|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.||hours*mm||Standard Deviation|Mean
665225|NCT01775189|Other Pre-specified|Drug Liking: Time to Maximum (Peak) Effect (TEmax)|"Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of neither like nor dislike (score of 50 mm), on the left with strong disliking (score of 0 mm) and on the right with strong liking (score of 100 mm). TEmax = Time to maximum observed score."|Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.||hours||Full Range|Median
665226|NCT01775189|Other Pre-specified|Drug Liking: Area Under Effect Curve (AUE) From 0-1 Hour, 0-8 Hour and 0-24 Hour|"Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of neither like nor dislike (score of 50 mm), on the left with strong disliking (score of 0 mm) and on the right with strong liking (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time 0 to x hours (0-x)."|Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.||hours*mm||Standard Deviation|Mean
665227|NCT01775189|Secondary|Pupillometry: Time to Maximum (Peak) Effect (TEmax)|Pupillometry assessments measure change in pupil size (miosis) as an indicator of opioid pharmacological properties. Participants have the size of pupil measured using a pupillometer. Measurements are made in a dimly lit (mesopic) room with controlled lighting conditions. The same eye for each participant was used for all measurements during the study. TEmax = Time to maximum observed score.|Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.||hours||Full Range|Median
665228|NCT01775189|Secondary|Pupillometry: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour|Pupillometry assessments measure change in pupil size (miosis) as an indicator of opioid pharmacological properties. Participants have the size of pupil measured using a pupillometer. Measurements are made in a dimly lit (mesopic) room with controlled lighting conditions. The same eye for each participant was used for all measurements during the study. AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x).|Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.||hours*mm||Standard Deviation|Mean
665229|NCT01775189|Secondary|Pupillometry: Peak Effect (Emax)|Pupillometry assessments measure change in pupil size (miosis) as an indicator of opioid pharmacological properties. Participants have the size of pupil measured using a pupillometer. Measurements are made in a dimly lit (mesopic) room with controlled lighting conditions. The same eye for each participant was used for all measurements during the study. Emax = Maximum observed score.|Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose PD data from each period. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.||mm||Standard Deviation|Mean
665230|NCT01775189|Secondary|Percentage of Dose (Drug Powder) Insufflated|The percentage of dose insufflated, was based on a calculation of the weight of powder remaining (if any) following each dosing during the intervention period.|Intervention period: 0 Hour post-dose|Safety analysis set included all participants who received at least 1 dose of study drug, beginning with the naloxone challenge phase.||percentage of dose||Standard Deviation|Mean
665231|NCT01775189|Secondary|Dizzy: Time to Maximum (Peak) Effect (TEmax)|Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.||hours||Full Range|Median
665232|NCT01775189|Secondary|Dizzy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour|Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x).|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.||hours*mm||Standard Deviation|Mean
665233|NCT01775189|Secondary|Dizzy: Peak Effect (Emax)|Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.||mm||Standard Deviation|Mean
666050|NCT01763905|Secondary|Change From Baseline in LDL-C at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||mg/dL||Standard Error|Least Squares Mean
665234|NCT01775189|Secondary|Sleepy: Time to Maximum (Peak) Effect (TEmax)|Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.||hours||Full Range|Median
665235|NCT01775189|Secondary|Sleepy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour|Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x).|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.||hours*mm||Standard Deviation|Mean
665236|NCT01775189|Secondary|Sleepy: Peak Effect (Emax)|Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.||mm||Standard Deviation|Mean
665237|NCT01775189|Secondary|Nausea: Time to Maximum (Peak) Effect (TEmax)|Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.||hours||Full Range|Median
665238|NCT01775189|Secondary|Nausea: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour|Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x).|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.||hours*mm||Standard Deviation|Mean
665239|NCT01775189|Secondary|Nausea: Peak Effect (Emax)|Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.||mm||Standard Deviation|Mean
665240|NCT01775189|Secondary|Feel Sick: Time to Maximum (Peak) Effect (TEmax)|Feel Sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.||hours||Full Range|Median
665241|NCT01775189|Secondary|Feel Sick: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour|Feel Sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x).|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.||hours*mm||Standard Deviation|Mean
665242|NCT01775189|Secondary|Feel Sick: Peak Effect (Emax)|Feel Sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.|Intervention periods: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.||mm||Standard Deviation|Mean
665243|NCT01775189|Secondary|Bad Drug Effects: Time to Maximum (Peak) Effect (TEmax)|Bad Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.|Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.||hours||Full Range|Median
665244|NCT01775189|Secondary|Bad Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour|Bad Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x).|Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.||hours*mm||Standard Deviation|Mean
665345|NCT01774097|Primary|Leg Collateral Count (Via Contrast Enhanced-MR)|The placebo adjusted average change in the number of collateral vessels over time.|Assessed at baseline and 6 months|Participants who had available analyzable baseline and 6 month MRI imaging||vessel count||Standard Deviation|Mean
665245|NCT01775189|Secondary|Bad Drug Effects: Peak Effect (Emax)|Bad Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.|Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.||mm||Standard Deviation|Mean
665246|NCT01775189|Secondary|Good Drug Effects: Time to Maximum (Peak) Effect (TEmax)|Good Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.|Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.||hours||Full Range|Median
665247|NCT01775189|Secondary|Good Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour|Good Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x).|Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.||hours*mm||Standard Deviation|Mean
665248|NCT01775189|Secondary|Good Drug Effects: Peak Effect (Emax)|Good Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.|Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.||mm||Standard Deviation|Mean
665249|NCT01775189|Secondary|Any Drug Effects: Time to Maximum (Peak) Effect (TEmax)|Any Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.|Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.||hours||Full Range|Median
665250|NCT01775189|Secondary|Any Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour|Any Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x).|Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.||hours*mm||Standard Deviation|Mean
665251|NCT01775189|Secondary|Any Drug Effects: Peak Effect (Emax)|Any Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.|Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.||mm||Standard Deviation|Mean
665252|NCT01775189|Secondary|Overall Drug Liking Effect at Hours 12 and 24|Overall drug liking VAS assesses the participant’s global perception of drug liking (that is, effects over the whole course of the drug experience including any carry-over effects). A 100 mm VAS is used to assess response based on a score ranging from 0 mm to 100 mm (0 mm = “strong disliking”, 50 mm = “neither like nor dislike”, and 100 mm= “strong liking”).|Intervention period: 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.||mm||Standard Deviation|Mean
665253|NCT01775189|Secondary|Overall Drug Liking: Mean Effect (Emean)|Overall drug liking VAS assesses the participant’s global perception of drug liking (that is, effects over the whole course of the drug experience including any carry-over effects). A 100 mm VAS is used to assess response based on a score ranging from 0 mm to 100 mm (0 mm = “strong disliking”, 50 mm = “neither like nor dislike”, and 100 mm= “strong liking”). Emean = Average observed score.|Intervention period: 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.||mm||Standard Deviation|Mean
665254|NCT01775189|Secondary|Overall Drug Liking: Peak Effect (Emax)|Overall drug liking VAS assesses the participant’s global perception of drug liking (that is, effects over the whole course of the drug experience including any carry-over effects). A 100 mm VAS is used to assess response based on a score ranging from 0 mm to 100 mm (0 mm = “strong disliking”, 50 mm = “neither like nor dislike”, and 100 mm= “strong liking”). Emax = Maximum observed score.|Intervention period: 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.||mm||Standard Deviation|Mean
665255|NCT01775189|Secondary|Take Drug Again Effect at Hours 12 and 24|Take drug again VAS is a subjective assessment of the degree to which a participant would desire to take the drug again if given the opportunity. It is presented on a 100 mm VAS with score ranging from 0 mm to 100 mm (score of 0 mm = “definitely would not”, 50 mm = “do not care”, and 100 mm = “definitely would”).|Intervention period: 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.||mm||Standard Deviation|Mean
665349|NCT01774045|Primary|Number of Dose Limiting Toxicity of Columbia-Suicide Severity Rating Scale (C-SSRS)|C-SSRS is composed of suicidal ideation, intensity of ideation and suicidal behavior and measured at each visit.|baseline to 72 hours|||participants|||Number
665256|NCT01775189|Secondary|Take Drug Again: Mean Effect (Emean)|Take drug again VAS is a subjective assessment of the degree to which a participant would desire to take the drug again if given the opportunity. It is presented on a 100 mm VAS with score ranging from 0 mm to 100 mm (score of 0 mm = “definitely would not”, 50 mm = “do not care”, and 100 mm = “definitely would”). Emean = Average observed score.|Intervention period: 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.||mm||Standard Deviation|Mean
665257|NCT01775189|Secondary|Take Drug Again: Peak Effect (Emax)|Take drug again VAS is a subjective assessment of the degree to which a participant would desire to take the drug again if given the opportunity. It is presented on a 100 mm VAS with score ranging from 0 mm to 100 mm (score of 0 mm = “definitely would not”, 50 mm = “do not care”, and 100 mm = “definitely would”). Emax = Maximum observed score.|Intervention period: 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.||mm||Standard Deviation|Mean
665258|NCT01775189|Primary|High: Area Under Effect Curve (AUE) From 0-2 Hour|High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hours.|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.||hours*mm||Standard Deviation|Mean
665259|NCT01775189|Primary|High: Peak Effect (Emax)|High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.||mm||Standard Deviation|Mean
665260|NCT01775189|Primary|Drug Liking: Area Under Effect Curve (AUE) From 0-2 Hour|"Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 millimeter (mm) bipolar VAS anchored in the center with a neutral anchor of neither like nor dislike (score of 50 mm), on the extreme left with strong disliking (score of 0 mm) and on the extreme right with strong liking (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hours."|Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.||hours*mm||Standard Deviation|Mean
665261|NCT01775189|Primary|Drug Liking: Peak Effect (Emax)|"Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 millimeter (mm) bipolar VAS anchored in the center with a neutral anchor of neither like nor dislike (score of 50 mm), on the extreme left with strong disliking (score of 0 mm) and on the extreme right with strong liking (score of 100 mm). Peak Effect (Emax) = Maximum observed score."|Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.||mm||Standard Deviation|Mean
665262|NCT01775137|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs/SAEs Leading to Discontinuation of Study Drug and Deaths Over 6 Treatment Cycles in Extension Study|An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. A SAE was defined as an event which was fatal or life threatening, required or prolonged hospitalisation, was significantly or permanently disabling or incapacitating, constituted a congenital anomaly or a birth defect, or encompassed any other clinically significant event that could jeopardize the participant or require medical or surgical intervention to prevent one of the aforementioned outcomes. Death was a fatal event leading to permanent cessations of all vital functions of the body.|Baseline (start of study treatment in extension study) to Day 673 (end of the extension study)|The analysis was performed in extension safety population, defined as all the participants who entered the extension study and received at least one dose of study drug within the extension.||Number of participants|||Number
665263|NCT01775137|Secondary|Time to First Hospitalization Due to Respiratory Related Serious Adverse Events (SAEs) in Extension Study|The day of first hospitalization due to serious respiratory related adverse events was analysed using Kaplan Meier estimate.|Baseline of extension study, Day 673 (end of extension study)|The analysis was performed in extension safety population.||Days||95% Confidence Interval|Median
665264|NCT01775137|Secondary|Number of Hospitalization Days Due to Respiratory Related Serious Adverse Events (SAEs) in Extension Study|The total number of hospitalisation days due to serious respiratory-related adverse events was analysed using Kaplan-Meier estimate.|Baseline of extension study, Day 673 (end of extension study)|The analysis was performed in extension safety population.||Days||Full Range|Median
665265|NCT01775137|Secondary|Percentage of Participants Hospitalized Due to Respiratory Related Serious Adverse Events (SAEs) in Extension Study|The percentage of the participants hospitalized due to serious respiratory-related AEs were determined during the extension study.|Baseline of extension study, Day 673 (end of the extension study)|The analysis was performed in extension safety population.||Percentage of participants|||Number
665266|NCT01775137|Secondary|Time to Use of New Anti-pseudomonal Antibiotics in Extension Study|Time to first usage of anti-pseudomonal antibiotic was determined using Kaplan Meier estimate. Participants without an event were censored at the date of the last available post-baseline measurement.|Baseline of extension study, Day 673 (end of extension study)|The analysis was performed in extension safety population.||Days||95% Confidence Interval|Median
665267|NCT01775137|Secondary|Total Number of Days of New Anti-pseudomonal Antibiotics Use in Extension Study|The total number of days with usage of new anti-pseudomonal antibiotic were determined.|Baseline of extension study, Day 673 (end of extension study)|The analysis was performed in extension safety population.The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively||Days||Full Range|Median
665269|NCT01775137|Secondary|Absolute Change From Baseline in Pseudomonas Aeruginosa Density Over 6 Treatment Cycles in Extension Study|Microbiological data was collected to understand the direct impact of the drug on the pathogens. Sputum samples were cultured for the presence of three Pseudomonas aeruginosa (P. aeruginosa) biotypes measured were mucoid, dry and small colony variant. If no P. aeruginosa was isolated for a visit, log10 colony forming units (CFU) was imputed with log10 (19) for all biotypes. Absolute change was calculated by using the formula = (Value at actual time point - start of extension value).|Baseline (start of study treatment in extension study), Day 365, Day 421, Day 477, Day 533, Day 589, Day 645, 673 (end of the extension study)|The analysis was performed in extension safety population, who had microbiological data at specified time points. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||log10 CFU||Standard Deviation|Mean
665270|NCT01775137|Secondary|Relative Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Percent Predicted Over 6 Treatment Cycles in Extension Study|FEV1 was defined as the volume of air expired in 1 second. FEV1 was assessed as a pulmonary function by using spirometry tests in accordance with American Thoracic Society/European Respiratory Society (ATS/ERS) criteria. FEV1% predicted is a normalized value of FEV1 calculated using the Knudsen equation, based upon participant’s age, gender and height. Relative change in FEV1 % predicted from baseline to pre-dose day X = ((pre-dose day*FEV1% predicted – baseline FEV1% predicted) / baseline FEV1 % predicted) x 100.|Baseline (start of study treatment in extension study), Day 365, Day 421, Day 477, Day 533, Day 589, Day 645, 673 (end of the extension study)|Extension safety population, defined as all the participants who entered the extension study and received at least one dose of study drug within the extension and had FEV1% values at both baseline and the post baseline time points. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||Percent change in FEV1 % predicted||Standard Deviation|Mean
665271|NCT01775137|Secondary|Acute Relative Change From Pre-dose to 30-minute Post-dose in Forced Expiratory Volume in One Second (FEV1) Percent Predicted Over 12 Treatment Cycles|FEV1 was defined as the volume of air expired in 1 second. FEV1 was assessed as a pulmonary function by using spirometry tests in accordance with American Thoracic Society/European Respiratory Society (ATS/ERS) criteria. Relative change in FEV1 % predicted was calculated by using the formula = 100 *(30-min post-dose value - pre-dose value) / pre-dose value.|Baseline (start of study treatment in core study), Day 29, Day 85, Day 141, Day 197, Day 253, Day 309, Day 337, Day 365, Day 421, Day 477, Day 533, Day 589, Day 645, 673 (end of the extension study)|The analysis was performed in extension safety population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||Percent change in FEV1 % predicted||Standard Deviation|Mean
665272|NCT01775137|Secondary|Time to First Hospitalization Due to Respiratory Related Serious Adverse Events (SAEs) Over 12 Treatment Cycles|The day of first hospitalization due to serious respiratory-related adverse events was analysed using Kaplan Meier estimate.|Baseline of core study, Day 673 (end of the extension study)|The analysis was performed in extension safety population.||Days||95% Confidence Interval|Median
665273|NCT01775137|Secondary|Number of Hospitalization Days Due to Respiratory Related Serious Adverse Events (SAEs) Over 12 Treatment Cycles|The total number of hospitalization days due to serious respiratory-related adverse events was analyzed using Kaplan-Meier estimate.|Baseline of core study, Day 673 (end of the extension study)|The analysis was performed in extension safety population.||Days||Full Range|Median
665274|NCT01775137|Secondary|The Percentage of the Participants Hospitalized Due to Serious Respiratory-related AEs Were Determined During the Study.|The percentage of the participants hospitalized due to serious respiratory-related AEs were determined during the study.|Baseline of core study, Day 673 (end of the extension study)|The analysis was performed in extension safety population.||Percentage of participants|||Number
665275|NCT01775137|Secondary|Time to Use of New Anti-pseudomonal Antibiotics Over 12 Treatment Cycles|Time to first usage of anti-pseudomonal antibiotic was determined using Kaplan Meier estimate. Participants without an event were censored at the date of the last available post-baseline measurement.|Baseline of core study, Day 673 (end of the extension study)|The analysis was performed in extension safety population.||Days||95% Confidence Interval|Median
665276|NCT01775137|Secondary|Total Number of Days of New Anti-pseudomonal Antibiotics Use Over 12 Treatment Cycles|The total number of days with usage of new anti-pseudomonal antibiotic were determined.|Baseline of core study, Day 673 (end of the extension study)|The analysis was performed in extension safety population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||Days||Full Range|Median
665277|NCT01775137|Secondary|Percentage of Participants Who Used New Anti-pseudomonal Antibiotics Over 12 Treatment Cycles|The rate of anti-pseudomonal antibiotics use were determined from the collection of concomitant medication during the study.|Baseline of core study, Day 673 (end of the extension study)|The analysis was performed in extension safety population.||Percentage of participants|||Number
665278|NCT01775137|Secondary|Tobramycin Minimum Inhibitory Concentration (MIC) 50 and MIC 90 Values for Pseudomonas Aeruginosa Over 12 Treatment Cycles|MIC was defined as the lowest concentration of an antimicrobial agent required to inhibit the visible growth of a microorganism after overnight incubation. Tobramycin MIC 50 and MIC 90 values were defined as the lowest concentration of tobramycin required to inhibit 50% and 90%, respectively, of the P. aeruginosa strains tested (mucoid,dry and small colony variant biotypes).|Baseline (start of study treatment in core study), Day 29, Day 85, Day 141, Day 197, Day 253, Day 309, Day 337, Day 365, Day 421, Day 477, Day 533, Day 589, Day 645, 673 (end of the extension study)|The analysis was performed in extension safety population, who had microbiological data at specified time points. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||micrograms/milliliters|||Number
665279|NCT01775137|Secondary|Absolute Change From Baseline in Pseudomonas Aeruginosa Sputum Density Over 12 Treatment Cycles|Microbiological data was collected to understand the direct impact of the drug on the pathogens. Sputum samples were cultured for the presence of three Pseudomonas aeruginosa (P. aeruginosa) biotypes measured were mucoid, dry and small colony variant. Absolute change was determined using the formula = (Post-baseline value- baseline value). If no P. aeruginosa was isolated for a visit, log10 colony forming units (CFU) was imputed with log10 (19) for all biotypes.|Baseline (start of study treatment in core study), Day 29, Day 85, Day 141, Day 197, Day 253, Day 309, Day 337, Day|||log 10 CFU/g||Standard Deviation|Mean
665280|NCT01775137|Secondary|Relative Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Percent Predicted Over 12 Treatment Cycles|FEV1 was defined as the volume of air expired in 1 second. FEV1 was assessed as a pulmonary function by using spirometry tests in accordance with American Thoracic Society/European Respiratory Society (ATS/ERS) criteria. FEV1% predicted is a normalized value of FEV1 calculated using the Knudsen equation, based upon participant’s age, gender and height. Relative change in FEV1 % predicted from baseline to pre-dose day X = ((pre-dose day*FEV1% predicted – baseline FEV1% predicted) / baseline FEV1 % predicted) x 100.|Baseline (start of study treatment in core study), Day 29, Day 85, Day 141, Day 197, Day 253, Day 309, Day 337, Day 365, Day 421, Day 477, Day 533, Day 589, Day 645, 673 (end of the extension study)|Extension safety population, defined as all the participants who entered the extension study and received at least one dose of study drug within the extension and had FEV1% values at both baseline and the post baseline time points. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||Percent change in FEV1 % predicted||Standard Deviation|Mean
665281|NCT01775137|Primary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs/SAEs Leading to Discontinuation of Study Drug and Deaths Over 12 Treatment Cycles|An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. A SAE was defined as an event which was fatal or life threatening, required or prolonged hospitalization, was significantly or permanently disabling or incapacitating, constituted a congenital anomaly or a birth defect, or encompassed any other clinically significant event that could jeopardize the participant or require medical or surgical intervention to prevent one of the aforementioned outcomes. Based on the severity, AEs were categorised into 3 types as mild, moderate and severe. Death was a fatal event leading to permanent cessations of all vital functions of the body.|Baseline (start of study treatment in core study) to Day 673 (end of the extension study)|The analysis was performed in extension safety population, defined as all the participants who entered the extension study and received at least one dose of study drug within the extension.||Participants|||Number
665282|NCT01774981|Secondary|Part B: Change From Baseline in Albuminuria Over Time|Albuminuria is defined as the ratio of albumin to creatinine.|Baseline, 19 Weeks|All randomized participants who received at least one dose of study drug and were in Part B with a baseline measurement and at least one post-baseline measurement.||mg/dl of albumin/ by mg/dl of creatinine||Standard Deviation|Mean
665283|NCT01774981|Secondary|Part B: Change From Baseline in Proteinuria Over Time|Proteinuria is defined as the ratio of protein to creatinine.|Baseline, 19 Weeks|All randomized participants who received at least one dose of study drug and were in Part B with a baseline measurement and at least one post-baseline measurement.||mg/dl of protein/ by mg/dl of creatinine||Standard Deviation|Mean
665284|NCT01774981|Primary|Part A and Part B: Number of Participants With One or More Treatment Emergent Adverse Events (AEs) or Any Serious AEs|Treatment-emergent adverse events (TEAEs) are events which were not present at baseline or pre-existing conditions at baseline that worsened in severity following the start of treatment. A summary of other non-serious Adverse Events (AEs), and all Serious Adverse Events (SAE's), regardless of causality, is located in the Reported Adverse Events section.|Baseline up to 32 Weeks|All randomized participants who received at least one dose of study drug.||Participants|||Count of Participants
665285|NCT01774981|Primary|Part B:Change From Baseline in Proteinuria|Proteinuria is defined as the ratio of protein to creatinine.|Baseline, 16 Weeks|All randomized participants who received at least one dose of study drug in Part B with a baseline measurement and at least one post-baseline measurement.||grams per 12 hour (g/12 hour)||Standard Deviation|Mean
665286|NCT01774968|Secondary|Change From Baseline to Week 24 in Body Weight Based on Baseline TDD Insulin ≥2.0 Units/kg and <2.0 Units/kg|Participants were stratified by their baseline TDD insulin (≤2.0 units/kg or >2.0 units/kg). LS means of change from baseline were calculated using MMRM with investigator, baseline HbA1c (≤8% or >8%), baseline TDD (≤300 or >300 units), treatment (TID or BID), visit, and treatment-by-visit interaction as fixed effects and baseline body weight as a covariate.|Baseline, Week 24|Randomized participants who received at least 1 dose of U-500R with evaluable body weight data.||kg||Standard Error|Least Squares Mean
665287|NCT01774968|Secondary|Change From Baseline to Week 24 in Percentage of Participants With Hypoglycemic Events Based on Baseline TDD Insulin ≥2.0 Units/kg and <2.0 Units/kg|Participants were stratified by their baseline TDD insulin (≤2.0 units (U)/kg or >2.0 U/kg). The percentage of participants at risk of developing hypoglycemia (including documented symptomatic, asymptomatic, probable symptomatic, unspecified, or severe hypoglycemia) is presented at Baseline and at Week 24 and was calculated using MMRM fit with options of the binomial distribution and log link function including treatment, TDD (>300 units or ≤300 units), pioglitazone use (yes or no), visit, and treatment-by-visit interaction as fixed effects, and baseline HbA1c value as a covariate.|Baseline, Week 24|Randomized participants who received at least 1 dose of U-500R.||percentage of participants|||Number
665288|NCT01774968|Secondary|Change From Baseline to Week 24 in 30-Day Adjusted Rate of Hypoglycemic Events Based on Baseline TDD Insulin ≤2.0 Units/kg and >2.0 Units/kg|Participants were stratified by their baseline TDD insulin (≤2.0 units/kg or >2.0 units/kg). Hypoglycemic events (HE) were classified as severe (an event requiring assistance from another person [accompanied by neurologic/cognitive impairment]), documented symptomatic (DS; an event which is associated with signs/symptoms of hypoglycemia and plasma glucose [PG] ≤70 milligrams per deciliter [mg/dL]), or nocturnal (Noc; any documented symptomatic HE that occurred between bedtime and waking). The 30-day adjusted rate of HE is summarized cumulatively at 24 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline, Week 24|Randomized participants who received at least 1 dose of U-500R.||events per participant per 30 days||Standard Deviation|Mean
665289|NCT01774968|Secondary|Change From Baseline to Week 24 in HbA1c Based on Baseline TDD Insulin ≤2.0 Units/kg and >2.0 Units/kg|Participants were stratified by their baseline TDD insulin (≤2.0 units/kg or >2.0 units/kg). LS means of change from baseline were calculated using MMRM with investigator, baseline TDD (≤300 or >300 units), treatment (TID or BID), visit, and treatment-by-visit interaction as fixed effects and baseline HbA1c as a covariate.|Baseline, Week 24|Randomized participants who received at least 1 dose of U-500R with evaluable HbA1c data.||percentage of HbA1c||Standard Error|Least Squares Mean
665374|NCT01772576|Other Pre-specified|Sensed Amplitude|Sensed Amplitude at 3 Months Post-Implant|3 Months Post-Implant|Patients having undergone the 3 months follow-up||mV||95% Confidence Interval|Mean
665290|NCT01774968|Secondary|Mean Change From Baseline to Week 24 in 7-Point Self-Monitored Blood Glucose (SMBG)|The 7-point SMBG is a participant self-administered blood glucose test which utilizes measurements at specific time points over a 24-hour period, including pre-morning meal (fasting), 2 hours after morning meal, pre-midday meal, 2 hours after midday meal, pre-evening meal, 2 hours after evening meal, and 3 AM. LS means of change from baseline were calculated using MMRM with investigator, baseline HbA1c (≤8% or >8%), baseline TDD (≤300 or >300 units), treatment (TID or BID), visit, and treatment-by-visit interaction as fixed effects and baseline SMBG as a covariate.|Baseline, Week 24|Randomized participants who received at least 1 dose of U-500R with evaluable SMBG data.||mg/dL||Standard Error|Least Squares Mean
665291|NCT01774968|Secondary|Change From Baseline to Week 24 in Number of Insulin Injections|The number of insulin injections per day at baseline (Week 0) and at Week 24 are presented.|Baseline, Week 24|Randomized participants who received at least 1 dose of U-500R. Last observation carried forward (LOCF) was used to impute missing postbaseline values.||injections per day||Standard Deviation|Mean
665292|NCT01774968|Secondary|Percentage of Participants With Hypoglycemic Events|Hypoglycemic events (HE) were classified as severe (an event requiring assistance from another person [accompanied by neurologic/cognitive impairment]), documented symptomatic (an event which is associated with signs/symptoms of hypoglycemia and plasma glucose [PG] ≤70 milligrams per deciliter [mg/dL]), documented symptomatic nocturnal (any documented symptomatic HE that occurred between bedtime and waking), or asymptomatic (any measured PG ≤70 mg/dL not accompanied by hypoglycemic signs/symptoms). The percentage of participants with HE at 24 weeks was calculated by the dividing the number of participants meeting the criteria by the total number of participants analyzed, multiplied by 100. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through Week 24|Randomized participants who received at least 1 dose of U-500R.||percentage of participants|||Number
665293|NCT01774968|Secondary|Time to Reach HbA1c Target Values|The cumulative number of participants achieving an HbA1c of ≤6.5%, <7.0%, <7.5%, and <8.0% is summarized at Weeks 6, 12, 18, and 24. The number of participants at risk (n) is also provided for each target value and timepoint.|Baseline through 6, 12, 18, and 24 weeks.|Randomized participants who received at least 1 dose of U-500R, who were not at the HbA1c target at baseline, and had evaluable HbA1c data||participants|||Number
665294|NCT01774968|Secondary|Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) Levels|LS means of change from baseline were calculated using MMRM with investigator, baseline HbA1c (≤8% or >8%), baseline TDD (≤300 or >300 units), treatment (TID or BID), visit, and treatment-by-visit interaction as fixed effects and baseline FPG as a covariate.|Baseline, Week 24|Randomized participants who received at least 1 dose of U-500R with evaluable FPG data.||milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
665295|NCT01774968|Secondary|Change From Baseline to Week 24 in Total Daily Dose (TDD; Units/kg) of Insulin|Baseline TDD was defined as the last U-100 insulin TDD prior to receiving the first dose of U-500R insulin. LS means of change from baseline were calculated using MMRM with investigator, baseline HbA1c (≤8% or >8%), treatment (TID or BID), visit, and treatment-by-visit interaction as fixed effects and baseline TDD as a covariate.|Baseline, Week 24|Randomized participants who received at least 1 dose of U-500R with evaluable TDD data.||units per kilogram (units/kg)||Standard Error|Least Squares Mean
665296|NCT01774968|Secondary|Change From Baseline to Week 24 in Total Daily Dose (TDD; Units) of Insulin|Baseline TDD was defined as the last U-100 insulin TDD prior to receiving the first dose of U-500R insulin. LS means of change from baseline were calculated using MMRM with investigator, baseline HbA1c (≤8% or >8%), treatment (TID or BID), visit, and treatment-by-visit interaction as fixed effects and baseline TDD as a covariate.|Baseline, Week 24|Randomized participants who received at least 1 dose of U-500R with evaluable TDD data.||units||Standard Error|Least Squares Mean
665297|NCT01774968|Secondary|Change From Baseline to Week 24 in Body Weight|LS means of change from baseline were calculated using MMRM with investigator, baseline HbA1c (≤8% or >8%), baseline TDD (≤300 or >300 units), treatment (TID or BID), visit, and treatment-by-visit interaction as fixed effects and baseline body weight as a covariate.|Baseline, Week 24|Randomized participants who received at least 1 dose of U-500R with evaluable body weight data.||kilograms (kg)||Standard Error|Least Squares Mean
665298|NCT01774968|Secondary|30-Day Adjusted Rate of Hypoglycemic Events|Hypoglycemic events (HE) were classified as severe (an event requiring assistance from another person [accompanied by neurologic/cognitive impairment]), documented symptomatic (an event which is associated with signs/symptoms of hypoglycemia and plasma glucose [PG] ≤70 milligrams per deciliter [mg/dL]), documented symptomatic nocturnal (any documented symptomatic HE that occurred between bedtime and waking), or asymptomatic (any measured PG ≤70 mg/dL not accompanied by hypoglycemic signs/symptoms). The 30-day adjusted rate of HE is summarized cumulatively at 24 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through Week 24|Randomized participants who received at least 1 dose of U-500R.||events per participant per 30 days||Standard Deviation|Mean
665299|NCT01774968|Secondary|Percentage of Participants Achieving HbA1c of ≤6.5%, <7.0%, <7.5%, and <8.0% at Week 24|The percentage of participants achieving an HbA1c of ≤6.5%, <7.0%, <7.5%, and <8.0% at Week 24 was calculated by the dividing the number of participants meeting the criteria by the total number of participants analyzed, multiplied by 100.|Week 24|Randomized participants who received at least 1 dose of U-500R, who were not at the HbA1c target at baseline, and had evaluable HbA1c data.||percentage of participants|||Number
665300|NCT01774968|Primary|Change From Baseline to Week 24 in Glycated Hemoglobin A1c (HbA1c)|Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with investigator, baseline total daily dose (TDD; ≤300 or >300 units), treatment (TID or BID), visit, and treatment-by-visit interaction as fixed effects and baseline HbA1c as a covariate.|Baseline, Week 24|Randomized participants who received at least 1 dose of U-500R with evaluable HbA1c data.||percentage of HbA1c||Standard Error|Least Squares Mean
665346|NCT01774097|Primary|Peak Walking Time (PWT)|The placebo adjusted average change over time in the maximum time (in minutes) walked by a patient on a treadmill under standardized conditions. The patient continues the test until walking can no longer be tolerated because of claudication symptoms.|Assessed at baseline and 6 months|Participants who had available analyzable baseline and 6 month treadmill test results.||minutes||Standard Deviation|Mean
666086|NCT01763827|Secondary|Percent Change From Baseline in Apolipoprotein B at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
665301|NCT01774929|Secondary|Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) Score at Day 15 and Day 30|The WOMAC is a self-administered; participant reported health status questionnaire designed to capture elements of pain, stiffness and physical impairment in participants with osteoarthritis. It consists of 24 questions (5 questions about pain, 2 about stiffness and 17 about physical function) scored on a VAS of 0 to 10 cm (0 cm=no pain to 10 cm=worse pain). Individual question responses are assigned a score of between 0=extreme and 4=none. Maximum scores for each element differ and therefore, scores were normalized. Total normalized score ranges from 0=worst to 100=best.|Baseline, Day 15 and Day 30|"ITT population included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy assessment. N” signifies those participants who were evaluated for this outcome measure."||Units on a scale||Standard Deviation|Mean
665302|NCT01774929|Primary|Pain Intensity Score at Day 30|The pain intensity was assessed by using a 10 cm VAS ranging from 0 cm=no pain to 10 cm=worse pain.|Day 30|ITT population included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy assessment. “N” signifies those participants who were evaluated for this outcome measure.||cm||Standard Deviation|Mean
665303|NCT01774929|Primary|Pain Intensity Score at Day 15|The pain intensity was assessed by using a 10 centimeter (cm) Visual Analog Scale (VAS) ranging from 0 cm=no pain to 10 cm=worse pain.|Day 15|Intent to treat (ITT) population included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy assessment. “N” signifies those participants who were evaluated for this outcome measure.||cm||Standard Deviation|Mean
665304|NCT01774903|Secondary|Number of Participants With Participant Global Assessment|Participants completed a global assessment with respect to pain control using a 9-point scale (-4 to 4; where, -4=100 percent worse, 0=unchanged and 4=100 percent improvement), safety using 5-point scale (1 to 5; where, 1=no, 2=Mild, 3=Moderate, 4=Severe and 5=most severe side effects) and 5-point overall satisfaction scale (1-5; where, 1=no, 2=mild, 3=moderate, 4=good, 5=excellent).|Day 30|PP population included all participants who completed the 30-day study.||participants|||Number
665305|NCT01774903|Secondary|Number of Participants With Investigator Global Assessment|Investigator completed a global assessment of the participants treatment with respect to pain control using a 9-point scale (-4 to 4; where, -4=100 percent worse, 0=unchanged and 4=100 percent improvement), safety using 5-point scale (1 to 5; where, 1=no, 2=mild, 3=moderate, 4=severe and 5=most severe side effects) and 5-point overall satisfaction scale (1-5; where, 1=no, 2=mild, 3=moderate, 4=good, 5=excellent).|Day 30|Per protocol (PP) population included all participants who completed the 30-day study.||participants|||Number
665306|NCT01774903|Primary|Pain Intensity at Day 30|Pain control was assessed by using a 10 cm VAS ranging from 0 to 10, where 0 cm=no pain and 10 cm=worse pain.|Day 30|ITT population included all participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment.||cm||Standard Deviation|Mean
665307|NCT01774903|Primary|Pain Intensity at Day 15|Pain control was assessed by using a 10 centimeter (cm) visual analog scale (VAS) ranging from 0 to 10, where 0 cm=no pain and 10 cm=worse pain.|Day 15|Intent-to-treat (ITT) population included all participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment.||cm||Standard Deviation|Mean
665308|NCT01774851|Primary|Progression Free Survival (PFS)|Target and non-target lesion antitumor response and disease progression during treatment with each dosing regimen will be evaluated using the international criteria proposed by the RECIST v1.1. Disease status will be assessed every 8 weeks from the date of the first dose of any drug in a regimen.|30 months|||weeks||95% Confidence Interval|Median
665309|NCT01774604|Secondary|Number of Patients With 30 Days Hospital Re-admission|Number of patients admitted to the hospital for any cause following ERCP|From randomization until 30 days after ERCP|||participants|||Number
665310|NCT01774604|Secondary|Number of Patient Deaths|Number of patients who died from any cause from the time of ERCP until 30 days post-procedure|From randomization to 30 days after ERCP|||participants|||Number
665311|NCT01774604|Secondary|Number of Patients Who Developed Gastrointestinal Bleeding|Number of patients who developed any type of gastrointestinal bleeding from time of ERCP to 30 days post procedure|From randomization to 30 days after ERCP|||participants|||Number
665312|NCT01774604|Secondary|Number of Patients Who Developed Mild Pancreatitis|Number of patient who developed mild acute pancreatitis based on the Atlanta Classification|From randomization to 30 days after ERCP|||participants|||Number
665313|NCT01774604|Secondary|Number of Patients Who Developed Moderately Severe Pancreatitis|Number of patients with moderately severe pancreatitis based on Atlanta Classification|From randomization to 30 days after ERCP|||participants|||Number
665314|NCT01774604|Secondary|Number of Patients Who Developed Severe Pancreatitis|Number of patients with severe acute pancreatitis based on the Atlanta Classification|From randomization to 30 days after ERCP|Assess the number of patients who developed severe acute pancreatitis||participants|||Number
665315|NCT01774604|Primary|Number of Patients Who Developed Acute Pancreatitis|Number of patients who developed pancreatitis following ERCP based on Atlanta Classification|From randomization to 30 days after ERCP|Patient who randomized into the study and received either rectal indomethacin or placebo||participants|||Number
665316|NCT01774344|Secondary|Disease Control Rate (DCR)|Disease control rate (DCR) was defined as the percentage of subjects whose best response was CR (CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target).), PR (PR: at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.), or stable disease (SD) (SD: steady state of disease. Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.) according to RECIST and RECIST 1.1 criteria. SD had to be maintained for at least 6 weeks from the first demonstration of that rating.|From date of randomization until 30 days after last study treatment (assessed every 6 weeks until PD; and after 8 cycle assessed every 12 weeks) (approximately 33 months)|||percentage of subjects|||Number
665347|NCT01774084|Secondary|Change in Beta Cell Function|Beta cell function is measured with intravenous glucose tolerance test (IVGTT)|Morning before surgery and up to two days after surgery|||Insulin AUC nmol * min/L||Standard Deviation|Mean
665348|NCT01774084|Primary|Change in Insulin Sensitivity|Insulin sensitivity is measured by euglycemic hyperinsulinemic clamp|Morning before surgery and up to two days after surgery|Per protocol||mg/(kg min)||Standard Deviation|Mean
665317|NCT01774344|Secondary|Objective Tumor Response Rate (ORR)|Objective tumor response rate (ORR) was defined as the percentage of subjects whose best tumor response CR or Partial Response (PR) observed during trial period assessed according to the mRECIST criteria and RECIST 1.1. CR= Disappearance of all clinical and radiological evidence of tumor (both target and non-target). Any pathological lymph nodes (whether target or non-target) must have a reduction in short axis to < 10 mm. PR= At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum, no unequivocal progression of existing non target lesions and no appearance of new lesions. Subjects prematurely discontinuing without an assessment were to be considered non-responders for the analysis.|From date of randomization until 30 days after last study treatment (assessed every 6 weeks until PD; and after 8 cycle assessed every 12 weeks) (approximately 33 months)|||percentage of subjects|||Number
665318|NCT01774344|Secondary|Progression Free Survival (PFS)|Progression Free Survival (PFS) was defined as the time (days) from date of randomization to date of disease progression (radiological or clinical) or death due to any cause, if death occurs before progression was documented. Death in the absence of progression was a PFS event only if it occurred within the 12+1 weeks for subjects who discontinued treatment prior to cycle 8 and 24+2 weeks for subjects who discontinued treatment after to cycle 8 of the last evaluable tumor assessment; PFS were censored at the date of the last evaluable tumor assessment, if it occurred later. Median and 95% confidence interval 95% were reported for the mRECIST and RECIST 1.1 analysis sets. Subjects still alive at the time of analysis were censored at their last date of last contact.|From date of randomization until 30 days after last study treatment (assessed every 6 weeks until PD; and after 8 cycle assessed every 12 weeks)|||days||95% Confidence Interval|Median
665319|NCT01774344|Secondary|Time to Progression (TTP)|TTP was the time (days) from randomization to radiological or clinical disease progression assessed by independent radiological review. Median and 95% confidence interval were reported for the modified response evaluation criteria in solid tumors (mRECIST) and response evaluation criteria in solid tumors version 1.1 (RECIST 1.1) analysis sets. Subjects still alive at the time of analysis were censored at their last date of last contact.|From date of randomization until 30 days after last study treatment (assessed every 6 weeks until PD; and after 8 cycle assessed every 12 weeks) (approximately 33 months)|||days||95% Confidence Interval|Median
665320|NCT01774344|Primary|Overall Survival (OS)|Overall Survival (OS) was defined as the time from date of randomization (Day 1) to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.|From randomization (Day 1) of the first subject until 419 days later|||days||95% Confidence Interval|Median
665321|NCT01774305|Secondary|Emergence Time|The emergence time will be recorded as the time from sevoflurane discontinuation to eye opening on command.|from sevoflurane discontinuation, up to the time of eye opening (estimated time : from 5 min to 10 min)|||sec||Standard Deviation|Mean
665322|NCT01774305|Primary|Coughing Grade|The coughing incidence and severity will be measured at extubation. Especially from the time of eye opening to 5 min after extubation. The coughing grade was assessed by the following cough grading system: Grade 0, no cough or single, mild cough at extubation; Grade 1, multiple, not sustained cough with mild severity; Grade 2, cough persistence less than 5 s with moderate severity; Grade 3, severe, persistent cough for more than 5 s (bucking).|from the time of eye opening to 5 min after extubation|||units on a scale||Standard Deviation|Mean
665323|NCT01774253|Secondary|Determine the Response Rates of Participants Based on Activation (or no Activation) of Their Hedgehog Signaling Pathway|To determine the objective response rates (partial and complete response) for patients without and with evidence of activation of Hedgehog signaling pathway in their tumors|3 years|No samples collected for hedgehog pathway. No data exists.|||||
665324|NCT01774253|Secondary|Evaluate the Impact of Quality of Life of Children Receiving Vismodegib Using PedsQL Questionnaires|Evaluate the impact of Quality of Life of children receiving Vismodegib using PedsQL questionnaires|2 years|QOL's not collected due to early closure of study. Data not collected or analyzed threfore no data exists.|||||
665325|NCT01774253|Secondary|Determine the Median Overall Survival (OS) of Participants|Overall Survival (OS) and clinical benefit (ORR + stable disease, SD)|2 years|Not evaluated due to early closure. Study data does not exist.|||||
665326|NCT01774253|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|To determine the safety and tolerability of Vismodegib as a single agent in pediatric and young adult patients with refractory or recurrent pontine glioma|2 years|||participants|||Number
665327|NCT01774253|Primary|Number of Days Participants Experienced Progression Free Survival (PFS)|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or the appearance of new lesions.|5 years|||Days||Full Range|Median
665328|NCT01774149|Other Pre-specified|Empowerment|Diabetes Empowerment Scale-Short Form (DES-SF) will be used to assess empowerment at the start of the study (week 1 post-enrollment) and during week 12 of intervention.|Up to 12 weeks post-enrollment.||||||
665329|NCT01774149|Other Pre-specified|Usability|System Usability Scale (SUS) will be applied to assess usability of the approach and recorded during the last week of intervention (week 12 for the intervention group and week 20 for the active comparator group).|up to 20 weeks post-enrollment||||||
665330|NCT01774149|Secondary|Change in HbA1c|HbA1c will be measured at the start of the study (week 1 post-enrollment) and during the last week of intervention (week 12 for the intervention group and week 20 for the active comparator group).|up to 20 weeks post-enrollment|11 participants in each group met for measurement of HbA1c. Reasons for not meeting was not recorded.||Percentage points||95% Confidence Interval|Mean
665331|NCT01774149|Primary|Change in the Frequency of Hyper- and Hypo-glycemic Events From Baseline to Week 8-12.|The number of self-measured blood glucose values < 4 mmol/L (72 mg/dL) or > 15 mmol/L (270 mg/dL) will be recorded during baseline (first 4 weeks post-enrollment/start of study) and during weeks 8-12 post-enrollment for all participants.|Up to 12 weeks post-enrollment|14 participants in each group were active users and had sufficient data to be analyzed for the outcome.||Events||95% Confidence Interval|Mean
665332|NCT01774110|Other Pre-specified|Change in 6-Minute Walk Test Distance From Time of Discharge From Rehabilitation (Initial Assessment) to 6 Months Post Enrollment|The 6-Minute Walk Test is a test of walking endurance and walking velocity.|This test will be done at the initiation of the protocol (initial assessment) and at 6 months post enrollment|||feet||Standard Deviation|Mean
665333|NCT01774110|Secondary|Change in Score on Stroke Rehabilitation Assessment of Movement (STREAM) Test From Initial Assessment to Discharge From Study.|The Stroke Rehabilitation Assessment of Movement (STREAM) is a test of motor recovery after stroke. There are 3 subsections of the test, an upper extremity section, a lower extremity section and a mobility section. Each section is scored independently and is normed to 100 points. Each of the 3 sections is then combined into a total overall function score which is also normed to 100. Therefore, a score of 100 represents full recovery whereas a score of 50 represents about 50% recovery from the stroke.|This test will be done at the initiation of the protocol (initial assessment) and at 6 months post enrollment|||scores on a scale||Standard Deviation|Mean
665334|NCT01774110|Primary|Change in Walking Velocity From Initial Assessment to Completion of Study at 6 Months Post Enrollment|Computerized gait analysis is done by a mat system (GAITRite) that electronically calculates the velocity.|This will be done at the time of discharge from inpatient rehabilitation (the initial assessment point of the study) and at 6-months post enrollment.|||cm/sec||Standard Deviation|Mean
665335|NCT01774097|Secondary|Walking Impairment Questionnaire (WIQ)-Ability to Climb Stairs Score|The Walking Impairment Questionnaire (WIQ) assesses the severity of the subjective walking impairment on distance, speed, and stair climbing scales. It is administered as a self report. Range: Minimum score is 0, maximum 100. The measure represents the placebo adjusted average change in WIQ ability to climb stairs score assessed over time. The reported value is the estimate from regression analysis of the slope of the placebo adjusted measure over the time course of the trial adjusted for baseline weight.|Assessed as a trajectory (baseline, 1mos, 3mos, and 6 mos)|Participants who had available analyzable baseline, 1 month, 3 month, and 6 month WIQs||scores on a scale||Standard Deviation|Mean
665336|NCT01774097|Secondary|Walking Impairment Questionnaire (WIQ)- Walking Speed Score|The Walking Impairment Questionnaire (WIQ) assesses the severity of the subjective walking impairment on distance, speed, and stair climbing scales. It is administered as a self report. Range: Minimum score is 0, maximum 87. The measure represents the placebo adjusted average change in WIQ walking speed score assessed over time. The reported value is the estimate from regression analysis of the slope of the placebo adjusted measure over the time course of the trial adjusted for baseline weight.|Assessed as a trajectory (baseline, 1mos, 3mos, and 6 mos)|Participants who had available analyzable baseline, 1 month, 3 month, and 6 month WIQs||scores on a scale||Standard Deviation|Mean
665337|NCT01774097|Secondary|Walking Impairment Questionnaire (WIQ)-Walking Distance Score|The Walking Impairment Questionnaire (WIQ) assesses the severity of the subjective walking impairment on distance, speed, and stair climbing scales. It is administered as a self report. Range: Minimum score is 0.2, maximum 100. The measure represents the placebo adjusted average change in WIQ walking distance score assessed over time. The reported value is the estimate from regression analysis of the slope of the placebo adjusted measure over the time course of the trial adjusted for baseline weight.|Assessed as a trajectory (baseline, 1mos, 3mos, and 6 mos)|Participants who had available analyzable baseline, 1 month, 3 month, and 6 month WIQs.||scores on a scale||Standard Deviation|Mean
665338|NCT01774097|Secondary|Peripheral Artery Questionnaire (PAQ)|The Peripheral Artery Questionnaire (PAQ) assesses subjective physical limitations, leg symptoms, social function, treatment satisfaction, and quality of life. It is administered as a self report. Higher scores are indicative of better outcome. The summary scores is compiled by taking the mean of five subscales generated from the original questions. Range: Minimum score is 11.1, maximum 85. The measure represents placebo adjusted average change in Peripheral Artery Questionnaire (PAQ) summary score assessed over time. The reported value is the estimate from regression analysis of the slope of the placebo adjusted measure over the time course of the trial adjusted for baseline weight.|Assessed as a trajectory (baseline, 1mos, 3mos, and 6 mos)|Participants who had available analyzable baseline, 1 month, 3 month, and 6 month PAQs.||scores on a scale||Standard Deviation|Mean
665339|NCT01774097|Secondary|Peak Walking Time (PWT)|The average change in maximum time (in minutes) walked by a patient on a treadmill under standardized conditions. The patient continues the test until walking can no longer be tolerated because of claudication symptoms.|Assessed at baseline and 3 months|Participants who had available analyzable baseline, 3 month, and 6 month treadmill test results.||minutes||Standard Deviation|Mean
665340|NCT01774097|Secondary|Claudication Onset Time (COT)|Claudication Onset Time (COT) is the walking time at which patients first experience leg pain during a treadmill test. The measure represents placebo adjusted average change over time (in minutes) in the time walked by a patient on a treadmill under standardized conditions before the onset of claudication symptoms, regardless of whether this is manifested or characterized as muscle pain, ache, cramp, numbness or fatigue. This does not include joint pain or other pain not associated with claudication. The reported value is the estimate from regression analysis of the slope of the placebo adjusted measure over the time course of the trial adjusted for baseline weight.|Assessed as a trajectory (baseline, 3mos, and 6 mos)|Participants who had available analyzable baseline, 3 month, and 6 month treadmill test results.||minutes||Standard Deviation|Mean
665341|NCT01774097|Secondary|Post-exercise Ankle-Brachial Index (ABI)|ABI is the ratio of the blood pressure at the ankle to the blood pressure of the upper arm. Post-exercise ABI is collected routinely with the patient supine immediately following a treadmill test. This measure represents the placebo adjusted average change over time in arm and pedal (ankle) blood pressure. The reported value is the estimate from regression analysis of the slope of the placebo adjusted measure over the time course of the trial adjusted for baseline weight.|Assessed as a trajectory (baseline, 3mos, and 6 mos)|Participants with available analyzable ABI at baseline, 3 months, and 6 months||ratio||Standard Deviation|Mean
665342|NCT01774097|Secondary|Pre-exercise Ankle-Brachial Index (ABI)|ABI is the ratio of the blood pressure at the ankle to the blood pressure of the upper arm. Pre-exercise ABI is collected routinely with the patient supine immediately prior to a treadmill test. This measure represents the placebo adjusted average change over time in arm and pedal (ankle) blood pressure. The reported value is the estimate from regression analysis of the slope of the placebo adjusted measure over the time course of the trial adjusted for baseline weight.|Assessed as a trajectory (baseline, 3mos, and 6 mos)|Participants with available analyzable ABI data at baseline, 3 months, and 6 months||ratio||Standard Deviation|Mean
665343|NCT01774097|Primary|Capillary Perfusion|The placebo adjusted average change in capillary perfusion over time.|Assessed at baseline and 6 months|Participants with available analyzable MRI imaging at baseline and 6 months||percent||Standard Deviation|Mean
665350|NCT01774045|Primary|Number of Dose Limiting Toxicity of Laboratory Values|Laboratory tests are composed of hematology and blood chemistry and measured at each visit. Hematology are composed of RBC, WBC, platelets, hematocrit, hemoglobin, prothrombin time (PT) and partial thromboplastin time (aPTT). Blood chemistry are composed of AST, ALT, LDH, total bilirubin, BUN, serum creatinine, free thyroxine (FT4), TSH, sodium, calcium, potassium, glucose, LDL, HDL, cholesterol and HbA1c.|baseline to 72 hours|||participants|||Number
665351|NCT01774045|Primary|Number of Dose Limiting Toxicity of Vital Sign|Vital sign, including heart rate, blood pressure and body temperature, are measured at each visit and at 1,2,3,4,8,12 and 24 hours after drug administration.|baseline to 72 hours|||participants|||Number
665352|NCT01774045|Primary|Number of Dose Limiting Toxicity of Electrocardiograph|Electrocardiograph (ECG) is measured at each visit. At visit 2, subjects were measured at 1,2, 4, 8, 12 and 24 hours after drug administration.|baseline to 72 hours|||participants|||Number
665353|NCT01774045|Primary|Number of Dose Limiting Toxicity of Physical Examination|Physical examination, including skin, head, neck, eyes, ears, nose, throat, heart, lungs, abdomen (liver and spleen), neurological examination, lymph node and extremities, is measured at each visit from screening to follow-up.|baseline to 72 hours|||participants|||Number
665354|NCT01773889|Primary|Clinical Response Rate|Although positive clinical response criteria are based on RECIST criteria, failure to respond criteria are not based on RECIST criteria, which have unclear application to immune-based clinical trials. Instead, novel lack-of-failure criteria, rather than failure-of-success criteria have been written to avoid stopping therapy prematurely without compromising patient safety, to accommodate the uncertainties of assessing failure in this setting. The criteria as written are based on sound medical, scientific and ethical principles. The trial is further designed to help establish the utility of these novel criteria.|every 3 months until the date of first documented progression or date of death from any cause, assessed up to 10 years|||participants|||Number
665355|NCT01773473|Secondary|Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) at Week 26|LS means were calculated by MMRM analysis using change from baseline in 1.5-AG variables at all post baseline measurement as dependent variables, treatment, country, BG excursion, visit and treatment-by-visit interaction as fixed effects, baseline SMBG variable value as a covariate and participants as a random effect.|Baseline, Week 26|All randomized participants who received at least 1 dose of study drug and analyzed according to the assigned treatment regardless of study drug dose the participant received and had baseline and Week 26 1,5-AG measurements.||micrograms/milliliter (µg/mL)||95% Confidence Interval|Least Squares Mean
665356|NCT01773473|Secondary|Insulin Dose at Week 26|Insulin dose is the total daily dose including basal and prandial doses.|Week 26|All randomized participants who received at least 1 dose of study drug and analyzed according to the assigned treatment regardless of study drug dose the participant received and had Week 26 insulin dose measurement.||units of insulin per day (IU/day)||Standard Deviation|Mean
665357|NCT01773473|Secondary|Number of Hypoglycemic Events Baseline Through Week 26 (Incidence)|A hypoglycemic event is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia, or has a BG concentration of ≤ 70milligrams/deciliter [mg/dL (3.9 mmol/L)], even if it was not associated with signs, symptoms, or treatment consistent with current guidelines [American Diabetes Association (ADA) 2005].|Baseline through Week 26|All randomized participants who received at least 1 dose of study drug.||events|||Number
665358|NCT01773473|Secondary|Change From Baseline in Body Weight at Week 26|LS means were calculated by MMRM analysis using change from baseline in weight variables at all post baseline measurement as dependent variables, treatment, country, BG excursion, visit and treatment-by-visit interaction as fixed effects, baseline SMBG variable value as a covariate and participants as a random effect.|Baseline, Week 26|All randomized participants who received at least 1 dose of study drug and had baseline and Week 26 body weight measurements.||kilogram (kg)||95% Confidence Interval|Least Squares Mean
665359|NCT01773473|Secondary|Change From Baseline in Fasting Blood Glucose (FBG) at Week 26|LS means were calculated by MMRM analysis using change from baseline in FBG variables at all post baseline measurement as dependent variables, treatment, country, BG excursion, visit and treatment-by-visit interaction as fixed effects, baseline self-monitoring blood glucose (SMBG) variable value as a covariate and participants as a random effect.|Baseline, Week 26|All randomized participants who received at least 1 dose of study drug and analyzed according to the assigned treatment regardless of study drug dose the participant received and had baseline and Week 26 FBG measurement.||millimoles per liter (mmol/L)||95% Confidence Interval|Least Squares Mean
665360|NCT01773473|Secondary|Percentage of Participants Achieving HbA1c of <7.0% or ≤6.5% Baseline Through Week 26|HbA1c is the glycosylated fraction of hemoglobin A which provides an estimate of a participant’s blood sugar control over a 6- to 12-week period. The percentage of participants with HbA1c <7.0% or HbA1c ≤6.5% is calculated as the number of participants with an HbA1c level of the cut-off value (<7.0% or ≤6.5%) divided by the number of participants treated, then multiplied by 100.|Baseline through Week 26|All randomized participants who received at least 1 dose of study drug and analyzed according to the assigned treatment regardless of study drug dose the participant received and had baseline and at least 1 post-baseline HbA1c measurement.||percentage of participants|||Number
665361|NCT01773473|Primary|Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26|HbA1c is the glycosylated fraction of hemoglobin A which provides an estimate of a participant’s blood sugar control over a 6- to 12-week period. Least Squares (LS) means were calculated by Mixed Models Repeated Measurements (MMRM) analysis using change from baseline in HbA1c at all post baseline measurement as dependent variables, treatment, blood glucose (BG) excursion, country, visit and treatment-by-visit interaction as fixed effects, baseline HbA1c value as a covariate and participants as a random effect.|Baseline, Week 26|All randomized participants who received at least 1 dose of study drug and analyzed according to the assigned treatment regardless of study drug dose the participant received and had baseline and Week 26 HbA1c measurements.||percentage of glycosylated hemoglobin||95% Confidence Interval|Least Squares Mean
665375|NCT01772576|Other Pre-specified|Pacing Threshold|Pacing Threshold at 0.5 ms pulse width at 3 Months Post-Implant|3-months post-implant|Patients having undergone the 3 months follow-up visit.||Volt||95% Confidence Interval|Mean
665376|NCT01772576|Other Pre-specified|Complication Free Rate|Lead-related Complication-Free Rate from 3 Months through 24 Months Post-Implant|3 Months through 24 Months Post-Implant|Patients remaining after the 3 months follow-up in the study until the 24 months follow-up.||percentage of all participants||95% Confidence Interval|Number
665362|NCT01773291|Secondary|Muscle Power (MP)|"Medical Research Council (MRC) muscle-grading scale Grade MRC grade of muscle strength 0 No movement
Flicker of movement only
Movement possible when assisted by gravity or gravity is eliminated
Movement possible against gravity but without imposed resistance
Weak movement possible against gravity
Normal movement against gravity and against imposed resistance
The 4 muscle groups were assessed on the 0 to 5 scale and scores were summed before and after treatment during hospitalization. The total score ranges from 0-20, with higher score indicating better outcome."|6 weeks|The subjects were treated 3 times a week (maximum 18 sessions in 6 weeks). The MP was measured before and after treatment during hospitalization.||units on a scale||Standard Deviation|Mean
665363|NCT01773291|Primary|Glasgow Coma Scale (GCS)|"Eye response (E)
There are four grades starting with the most severe:
No eye opening
Eye opening in response to pain stimulus.
Eye opening to speech.
Eyes opening spontaneously Verbal response (V)
There are five grades starting with the most severe:
No verbal response
Incomprehensible sounds.
Inappropriate words.
Confused.
Oriented. Motor response (M)
There are six grades:
No motor response
Decerebrate posturing accentuated by pain
Decorticate posturing accentuated by pain
Withdrawal from pain
Localizes to pain
Obeys commands
The sum of the score was measured (3 - 15) before and after treatment during hospitalization. The higher score, the better outcome."|6 weeks|The subjects were treated 3 times a week (maximum 18 sessions in 6 weeks). The GCS was measured before and after treatment during hospitalization.||units on a scale||Standard Deviation|Mean
665364|NCT01773226|Secondary|Physical Function Score|Changed Outcome Measure Description to: The Western Ontario and McMaster Universities osteoarthritis index questionnaire using the Likert scale (WOMAC LK), Version 3.1 questionnaire has 24 items that the patient addresses about the knee: 5 items on the pain subscale, 2 on the stiffness subscale, and 17 on the physical function subscale. Each item was to be answered on a 5-point Likert scale, with grading from 0 (none or never) to 4 (extreme or always). The scores are summed for items in each subscale, with possible ranges as follows: pain=0-20, stiffness=0-8, physical function=0-68. A higher score indicates worse pain, stiffness, or functional limitation.|Baseline, Week 1, Week 2, and at Months 1, 3, and 6.|Results of the WOMAC LK 3.1 questionnaire (pain, stiffness, and functionality subscores) were summarized by timepoint.||Scores on a WOMAC functionality scale||Standard Deviation|Mean
665365|NCT01773226|Secondary|Stiffness Score|Changed Outcome Measure Description to: The Western Ontario and McMaster Universities osteoarthritis index questionnaire using the Likert scale (WOMAC LK), Version 3.1 questionnaire has 24 items that the patient addresses about the knee: 5 items on the pain subscale, 2 on the stiffness subscale, and 17 on the physical function subscale. Each item was to be answered on a 5-point Likert scale, with grading from 0 (none or never) to 4 (extreme or always). The scores are summed for items in each subscale, with possible ranges as follows: pain=0-20, stiffness=0-8, physical function=0-68. A higher score indicates worse pain, stiffness, or functional limitation.|Baseline, Week 1, Week 2, and at Months 1, 3, and 6.|Results of the WOMAC LK 3.1 questionnaire (pain, stiffness, and functionality subscores) were summarized by timepoint.||Scores on a WOMAC stiffness scale||Standard Deviation|Mean
665366|NCT01773226|Secondary|Pain Score|The Western Ontario and McMaster Universities osteoarthritis index questionnaire using the Likert scale (WOMAC LK), Version 3.1 questionnaire has 24 items that the patient addresses about the knee: 5 items on the pain subscale, 2 on the stiffness subscale, and 17 on the physical function subscale. Each item was to be answered on a 5-point Likert scale, with grading from 0 (none or never) to 4 (extreme or always). The scores are summed for items in each subscale, with possible ranges as follows: pain=0-20, stiffness=0-8, physical function=0-68. A higher score indicates worse pain, stiffness, or functional limitation.|Baseline, Week 1, Week 2, and at Months 1, 3, and 6.|Results of the WOMAC LK 3.1 questionnaire (pain, stiffness, and functionality subscores) were summarized by timepoint.||Scores on a WOMAC pain scale||Standard Deviation|Mean
665367|NCT01773226|Secondary|Number of Patients Using Rescue Medication|Explore the potential for an analgesic effect of a single dose of APS in patients with OA of the knee.|Up to 6 months post-injection|The incidence of patients using rescue medication for OA pain.||Frequency of Patients using Rescue medic|||Number
665368|NCT01773226|Primary|Number of Adverse Events|Safety and tolerability will be assessed from AEs and injection-site reactions, physical examinations, knee examinations, vital signs, ECGs, and clinical laboratory tests (hematology, coagulation, blood chemistry, and urinalysis) evaluated at baseline (pre-injection) and post-injection up to 6 months.|Up to 6 months post-injection|In cases where a patient reported multiple occurrences of an AE, the first occurrence of the worst reported case of the event was to be used for the purpose of analysis.||Adverse Events (AEs)|||Number
665369|NCT01773135|Primary|Evaluate if ACTH Can be Used as a Predictive Marker for Preterm Labor|measurement of maternal serum ACTH in women daignosed as threatened preterm labor to evaluate if this hormone can be used as a predictive marker for preterm labor|9 weeks|||pg/ml||Inter-Quartile Range|Median
665370|NCT01773122|Secondary|Maximum Plasma Level (Cmax) of Dapsone Metabolites|Cmax is the maximum plasma level following multiple doses of dapsone. Plasma is the liquid component of the blood in which the blood cells are suspended. The dapsone metabolites are N-acetyl dapsone and dapsone hydroxylamine.|Day 28|All treated subjects with data for this time point||Nanograms/Milliliter (ng/mL)||Standard Deviation|Mean
665371|NCT01773122|Primary|Maximum Plasma Level (Cmax) of Dapsone|Cmax is the maximum plasma level following multiple doses of dapsone. Plasma is the liquid component of the blood in which the blood cells are suspended.|Day 28|All treated subjects with data for this time point||Nanograms/Milliliter (ng/mL)||Standard Deviation|Mean
665372|NCT01772654|Primary|Intensity of the MRI Signal in the Left Temporal Precentral Zone|Subjects who were already scheduled to have a Magnetic Resonance Imaging (MRI) procedure as part of an evaluation for epilepsy had an additional sequence added during the MRI. The additional MRI sequence was called Arterial Spin Labeling (ASL), and consisted of 4 minutes additional time in the MRI scanner. The ASL sequence did not use any contrast or radiation. The ASL sequence is a blood flow measure, and compared the intensity of the MRI signal in patients with left temporal lobe epilepsy to the intensity of the MRI signal in patients with normal brains. Intensity of MRI signal is measured on the MRI image slices in different anatomic regions as an optical density (dark to bright). It is then referenced to a region of the brain that is considered stable standard as a ratio.|Approximately in the middle of the MRI procedure|||ratio||Standard Deviation|Mean
665373|NCT01772576|Other Pre-specified|Pacing Impedance|Pacing Impedance at 3 Months Post-Implant|3 Months Post-Implant|Patients with 3 month follow-up||Ohm||95% Confidence Interval|Mean
665377|NCT01772576|Secondary|Complication Free Rate|Lead-related Complication-Free Rate from 3 Months through 15 Months Post-Implant.|3 months through 15 months post implant|156 patients remained after 3 months in the study without lead related complication. Those were used for the secondary endpoint.||percentage of total participants||95% Confidence Interval|Number
665378|NCT01772576|Primary|Complication Free Rate|Lead-related Complication-Free Rate (CFR) from Implant through 3 Months Post-Implant.|3-months follow-up|Patients enrolled in the study and having received the RELIANCE 4FRONT active fixation lead||percentage of all subjects||95% Confidence Interval|Number
665379|NCT01772550|Secondary|Catheter Integrity Failure|"Catheter integrity failure generally refers to any portion of the device breaking or malfunctioning so that its proper function is no longer assured. In this study, the most relevant catheter integrity failures to be assessed were fluid leakage, tubing rupture, or tubing separation from the hub.
The number of subjects who experienced injections with a catheter integrity failure during injection is reported. The information about the IV catheter was collected by a clinically qualified study staff member (e.g., the Principal or sub-Investigator, or Study Coordinator) after the power injection."|immediately after power injection|One subject randomized to the 18 GA conventional IV was excluded from the analysis as the required minimum flow rate could not be achieved due to IV placement. Non-randomized group analysis includes 1 subject with media extravasation with first study IV (adverse event). Subject was discontinued and not included in primary outcomes analysis.||participants|||Number
665380|NCT01772550|Secondary|Catheter Transfixation|The number of subjects who experienced catheter transfixation (the IV penetrating the opposite wall of the vein) is reported. This information was collected by a clinically qualified study staff member (e.g., the Principal or sub-Investigator, or Study Coordinator) after the power injection.|immediately after power injection|One subject randomized to the 18 GA conventional IV was excluded from the analysis as the required minimum flow rate could not be achieved due to IV placement. Non-randomized group analysis includes 1 subject with media extravasation with first study IV (adverse event). Subject was discontinued and not included in primary outcomes analysis.||participants|||Number
665381|NCT01772550|Secondary|Catheter Dislodgement|The number of subjects who experienced partial or complete dislodgement of the catheter from the subject prior to power injection procedure completion is reported. The information about the IV catheter was collected by a clinically qualified study staff member (e.g., the Principal or sub-Investigator, or Study Coordinator) after the power injection.|Immediately following power injection|One subject randomized to the 18 GA conventional IV was excluded from the analysis as the required minimum flow rate could not be achieved due to IV placement. Non-randomized group analysis includes 1 subject with media extravasation with first study IV (adverse event). Subject was discontinued and not included in primary outcomes analysis.||participants|||Number
665382|NCT01772550|Secondary|High Pressure Alarm|The number of subjects who experienced injections with activation of the high pressure alarm is reported. Immediately following the power injection, the clinician performing the power injection recorded whether or not the high pressure alarm sounded.|immediately after contrast injection|One subject randomized to the 18 GA conventional IV was excluded from the analysis as the required minimum flow rate could not be achieved due to IV placement. Non-randomized group analysis includes 1 subject with media extravasation with first study IV (adverse event). Subject was discontinued and not included in primary outcomes analysis.||participants|||Number
665383|NCT01772550|Secondary|Automatic Injection Shutoff|The number of subjects who experienced injections with automatic injection shutoff is reported. Immediately after the power injection, the injection technician recorded whether or not an automatic injection shutoff occurred.|immediately after contrast injection|One subject randomized to the 18 GA conventional IV was excluded from the analysis as the required minimum flow rate could not be achieved due to IV placement. Non-randomized group analysis includes 1 subject with media extravasation with first study IV (adverse event). Subject was discontinued and not included in primary outcomes analysis.||participants|||Number
665384|NCT01772550|Secondary|Extravasation of Contrast Media|The number of subjects who experienced injections with extravasation of contrast media is reported.|upon contrast injection|One subject randomized to the 18 GA IV was excluded from the per-protocol analysis as minimum flow rate could not be achieved. Non-randomized group analysis includes 1 subject with media extravasation with first study IV (adverse event). Subject was discontinued and not included in primary outcomes analysis.||participants|||Number
665385|NCT01772550|Secondary|Catheter Insertion Success|"Insertion is successful when the catheter can be flushed or infused to demonstrate patency, and there is no inadvertent administration of a solution or medication into the tissue surrounding the IV catheter.
The number of participants with successfully inserted catheters after the first or second insertion attempt is reported. The clinician inserting the IV catheter made a clinical judgement as to whether the catheter was successfully placed; the protocol did not define more specific criteria. Catheter insertion success rates were determined from each IV insertion attempted in the Study."|immediately after catheter insertion|All subjects for whom an insertion was attempted are included in the analysis for insertion success. This includes some subjects that did not go on to complete the study.||participants|||Number
665386|NCT01772550|Secondary|Maximum Flow Rate|Maximum flow rate guidelines provided in the BD Nexiva Diffusics Instructions for Use were to be followed. The maximum flow rate (milliliters per second, or mL/sec) utilized was recorded by the Radiology Technician immediately following the power injection of iodinated intravenous contrast media. Results are descriptively summarized; no formal acceptance criteria were specified by the protocol.|immediately after power injection|One subject randomized to the 18 GA conventional IV was excluded from the analysis as the required minimum flow rate could not be achieved due to IV placement. Non-randomized flow rate analysis only includes subjects who completed successful contrast delivery; one subject with extravasation upon delivery was discontinued and is not included.||mL/second||Standard Deviation|Mean
665396|NCT01772368|Secondary|Time of Maximum Observed Plasma Concentration (Tmax) of Salmeterol|Blood samples for measurement of plasma SAL concentrations were obtained during each treatment visit (subjects 18 years of age and older only) and pharmacokinetic parameters were derived.|Predose (0), and at 5, 10, 15 and 30 minutes, 1, 1.5, 2, 3, 4, 8, and 12 hours postdose|Pharmacokinetic Analysis set. PK parameters for Salmeterol were not run for Fp MDPI experience.||hours||Full Range|Median
665621|NCT01768013|Primary|Pharmacokinetic: AUClast of Calcipotriol|The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for calcipotriol was determined|Day 1|||h*pg/mL||Standard Deviation|Mean
665387|NCT01772550|Secondary|Complete Chest and Abdomen CT - Average Hounsfield Units as a Measure of Aortic Contrast Delivery and Enhancement in Subjects Whose Veins Could Accommodate an 18 GA IV Catheter (Randomized Subjects)|Objective image quality assessment was performed by a board-certified Research Radiologist, by measuring the post-contrast aortic attenuation in Hounsfield Units (HU) at either the aortic arch if chest is imaged or the diaphragmatic crus and above the aortic bifurcation or on the most inferior image on the arterial phase. Hounsfield units within the proximal and distal aorta were recorded for each subject image reviewed. The average number of HU for each group in the Study are reported descriptively; formal acceptance criteria for this objective are not specified.|at the time of image assessment|54 subjects had HU measurements available from complete chest and abdomen CT imaging.||Hounsfield Units||Standard Deviation|Mean
665388|NCT01772550|Secondary|Chest CT - Average Hounsfield Units as a Measure of Aortic Contrast Delivery and Enhancement in Subjects Whose Veins Could Accommodate an 18 GA IV Catheter (Randomized Subjects)|Objective image quality assessment was performed by a board-certified Research Radiologist, by measuring the post-contrast aortic attenuation in Hounsfield Units (HU) at either the aortic arch if chest is imaged or the diaphragmatic crus and above the aortic bifurcation or on the most inferior image on the arterial phase. Hounsfield units within the proximal and distal aorta were recorded for each subject image reviewed. The average number of HU for each group in the Study are reported descriptively; formal acceptance criteria for this objective are not specified.|at the time of image assessment|20 subjects had HU measurements available from thoracic CT imaging.||Hounsfield Units||Standard Deviation|Mean
665389|NCT01772550|Secondary|Abdomen CT - Average Hounsfield Units as a Measure of Aortic Contrast Delivery and Enhancement in Randomized Subjects|Objective image quality assessment was performed by a board-certified Research Radiologist, by measuring the post-contrast aortic attenuation in Hounsfield Units (HU) at either the aortic arch if chest is imaged or the diaphragmatic crus and above the aortic bifurcation or on the most inferior image on the arterial phase. Hounsfield units within the proximal and distal aorta were recorded for each subject image reviewed. The average number of HU for each group in the Study are reported descriptively; formal acceptance criteria for this objective are not specified.|at the time of image assessment|126 subjects had HU measurements available from abdominal CT imaging.||Hounsfield Units||Standard Deviation|Mean
665390|NCT01772550|Primary|Acceptable Image Quality|"Study images were assessed by a US board-certified radiologist to determine whether the image is of acceptable quality. The radiologist was not informed of the study device used for the injection that produced the image under evaluation. Subjective image quality assessment for acceptability was determined by:
The report of the reading radiologist in the section of the report where the radiologist indicates if the image is acceptable or not. The absence of a comment in this section will be interpreted as acceptable, and,
the assessment of an independent single second reader (such as the subinvestigator or research radiologist) blinded to the reading radiologist's report and the infusion catheter type.
In the case of a non-concurrence, the Principal Investigator assessed the image and his or her assessment had final authority."|at the time of image assessment|One subject randomized to the 18 GA conventional catheter was excluded from the per-protocol analysis. Due to catheter placement, the required minimum flow rate of 5 mL/sec could not be achieved; contrast was administered at 4.5 mL/sec.||percentage of participants|||Number
665391|NCT01772537|Other Pre-specified|Serum Inflammatory Markers|Serum inflammatory markers will be compared per anesthetic group, Propofol versus Isoflurane. A sample of 10 individuals from each group will have biomarkers measured|From the start of the surgery to 24 hours post-op|No data is available for serum inflammatory markers. The study did not have adequate funding to appropriately measure these variables.|||||
665392|NCT01772537|Secondary|Number of Participants With Delirium as Assessed by the Confusion Assessment Method (CAM)|Delirium was measured using the Confusion Assessment Method and the Confusion Assessment Method- Intensive Care Unit (CAM-ICU) based upon post-operative location of patient. The patients were divided into to two groups, patients that had an open thoracoabdominal aneurysm repair versus patients that had stenting of their aneurysms. Patients that had stenting of their aneurysms were also randomized to receive either Propofol or Isoflurane as for their anesthetic.|Immediately after surgery and at 3 and 12 months post-op|Of the 6 patients that received an open thoracoabdominal aneurysm repair 2 were found to have delirium. Of the 5 subjects that had stenting and received Propofol as their primary anesthetic, 0 were found to have delirium. Of the 3 stenting subjects that received Isoflurane as their primary anesthetic, 1 were found to have delirium.||participants|||Number
665393|NCT01772537|Primary|Changes in CSF Levels of Amyloid|Quantitative levels of amyloid will be measured using ELISA assay technique in pg/ml to compare the differences between the group receiving Propofol and the groups receiving Isoflurane.|From insertion of spinal drain until removal|The data for changes in CSF levels of amyloid are not available. The study did not have adequate funding to appropriately measure these variables.|||||
665394|NCT01772537|Primary|Changes in Cerebrospinal Fluid (CSF) Levels of Tau|Quantitative levels of tau will be measured using ELISA assay technique in pg/ml to compare the differences between the group receiving Propofol and the groups receiving Isoflurane.|From insertion of spinal drain until removal|The data for changes in CSF levels of tau are not available. The study did not have adequate funding to appropriately measure these variables.|||||
665395|NCT01772368|Secondary|Patients With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period|"TEAEs were recorded during each double-blind treatment. In addition, at the end of each treatment, patients continued to use 2 inhalations of Fp MDPI 50 mcg (100 mcg total dose) twice daily, so adverse events during this treatment were assigned to Fp MDPI 50 mcg.
An adverse event was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relationship of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical in"|Day 1 up to Day 35|Safety population||Participants|||Count of Participants
665622|NCT01768013|Primary|Pharmacokinetic: Cmax of Calcipotriol|The mean Cmax (Maximum Observed Plasma Concentration) of calcipotriol was determined|Day 14|||pg/mL||Standard Deviation|Mean
665397|NCT01772368|Secondary|Maximum Observed Plasma Concentration (Cmax) of Salmeterol|Blood samples for measurement of plasma SAL concentrations were obtained during each treatment visit (subjects 18 years of age and older only) and pharmacokinetic parameters were derived. The primary pharmacokinetic parameters were AUC0-t and Cmax for Salmeterol.|Predose (0), and at 5, 10, 15 and 30 minutes, 1, 1.5, 2, 3, 4, 8, and 12 hours postdose|Pharmacokinetic Analysis set. PK parameters for Salmeterol were not run for Fp MDPI experience.||pg/mL||Standard Deviation|Mean
665398|NCT01772368|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Measurable Concentration (AUC0-t) of Salmeterol|Blood samples for measurement of plasma SAL concentrations were obtained during each treatment visit (subjects 18 years of age and older only) and pharmacokinetic parameters were derived. The primary pharmacokinetic parameters were AUC0-t and Cmax for Salmeterol.|Predose (0), and at 5, 10, 15 and 30 minutes, 1, 1.5, 2, 3, 4, 8, and 12 hours postdose|Pharmacokinetic Analysis set. PK parameters for Salmeterol were not run for Fp MDPI experience.||pg*hr/mL||Standard Deviation|Mean
665399|NCT01772368|Secondary|Change From Baseline at 12 Hours Post-Dose in Forced Expiratory Volume in One Second (FEV1) By Treatment|"The secondary efficacy variable was the change from period-specific baseline in FEV1 at 12 hours, calculated as FEV1 measured at 12 hours postdose after subtracting period-specific baseline FEV1 at each treatment period.
The period-specific baseline FEV1 was measured at predose within 5 minutes of AM dose administration at each treatment visit. If that value was missing, then FEV1 measured at 30 minutes predose was used as the period-specific baseline."|Pre-dose: 30 minutes prior, within 5 minutes of dose. Post-dose: 12 hours|The full analysis set (FAS) included all subjects in the ITT population who received at least 1 dose of study drug and had at least 1 evaluable standardized baseline-adjusted FEV1 AUC0-12.||mL||Standard Error|Least Squares Mean
665400|NCT01772368|Primary|Standardized Baseline-Adjusted Area Under the Curve For Forced Expiratory Volume In 1 Second Over 12 Hours Post-dose (FEV1 AUC0-12)|Standardized baseline-adjusted FEV1 AUC0-12 was defined as the area under the curve for baseline-adjusted FEV1 measurements from the predose to 12 hours postdose time points using the trapezoidal rule based on actual (not scheduled) time of measurement and was standardized by dividing the actual time of last non-missing FEV1 measurement. Baseline-adjusted FEV1 was calculated as postdose FEV1 after subtracting period-specific baseline FEV1. The period-specific baseline FEV1 was measured at predose within 5 minutes of AM dose administration at each treatment visit. If that value was missing, then FEV1 measured at 30 minutes predose was used as the period-specific baseline.|Pre-dose: 30 minutes prior, within 5 minutes of dose. Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 9, 12 hours|The full analysis set (FAS) included all subjects in the ITT population who received at least 1 dose of study drug and had at least 1 evaluable standardized baseline-adjusted FEV1 AUC0-12.||mL||Standard Error|Least Squares Mean
665401|NCT01772316|Secondary|Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Specified Time Points|The HAQ-DI is a questionnaire specific for rheumatoid arthritis and consists of 20 questions referring to 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Minimum score was 0, maximum score was 3. A smaller score indicated improvement.|Baseline, Week 48, Week 96|Per-protocol population included all participants who had at least one dose of study medication and at least one safety evaluation after dose administration. Here, 'n' represents the number of participants with a measure at the specified time point.||units on a scale||Standard Deviation|Mean
665402|NCT01772316|Secondary|Patient Pain VAS Score at Specified Time Points|This assessment represents the patient’s assessment of his/her current level of pain on a 100 mm horizontal VAS. The extreme left end of the line should be described as “no pain” and the extreme right end as “unbearable pain”. Scores ranged from 0 to 100 with a higher score indicating more pain. A negative change score indicated less pain.|Baseline, Week 48, Week 96|Per-protocol population included all participants who had at least one dose of study medication and at least one safety evaluation after dose administration. Here, 'n' represents the number of participants with a measure at the specified time point.||units on a scale||Standard Deviation|Mean
665403|NCT01772316|Secondary|Patient Global Visual Analog Score (VAS) at Specified Time Points|This assessment represents the patient’s overall assessment of their current disease activity on a 100 millimeter (mm) horizontal VAS. The extreme left end of the line should be described as “no disease activity” (symptom free and no arthritis symptoms) and the extreme right end as “maximum disease activity” (maximum arthritis disease activity). Scores ranged from 0 to 100 with a higher score indicating more disease activity. A negative change score indicated less disease activity.|Baseline, Week 48, Week 96|Per-protocol population included all participants who had at least one dose of study medication and at least one safety evaluation after dose administration. Here, 'n' represents the number of participants with a measure at the specified time point.||units on a scale||Standard Deviation|Mean
665404|NCT01772316|Secondary|Percentage of Participants With Disease-Modifying Antirheumatic Drugs (DMARDs)/Corticosteroid Dose Reductions and/or Discontinuation||Randomization of first participant to clinical cutoff date (19MAY2015) (approximately 29 months)|Per-protocol population included all participants who had at least one dose of study medication and at least one safety evaluation after dose administration.||percentage of participants|||Number
665405|NCT01772316|Secondary|Percentage of Participants With Remission (DAS28 <2.6 or SDAI </=3.3) at Weeks 48 and 96||Week 48, Week 96|Per-protocol population included all participants who had at least one dose of study medication and at least one safety evaluation after dose administration.||percentage of participants|||Number
665406|NCT01772316|Primary|Change From Baseline in SJC at Week 96|An assessment of 66 joints for swelling and 68 joints for tenderness was made. Joints were assessed and classified as tender/not tender and swollen/not swollen by pressure and joint manipulation on physical examination. Change in SJC = SJC at Week 96 - SJC at Baseline. A negative number indicated improvement.|Baseline, Week 96|Per-protocol population included all participants who had at least one dose of study medication and at least one safety evaluation after dose administration.||units on a scale||Standard Deviation|Mean
665407|NCT01772316|Primary|Change From Baseline in Swollen Joint Count (SJC) at Week 48|An assessment of 66 joints for swelling and 68 joints for tenderness was made. Joints were assessed and classified as tender/not tender and swollen/not swollen by pressure and joint manipulation on physical examination. A negative number indicated improvement.|Baseline, Week 48|Per-protocol population included all participants who had at least one dose of study medication and at least one safety evaluation after dose administration.||units on a scale||Standard Deviation|Mean
665408|NCT01772316|Primary|Change From Baseline in Total TJC at Week 96|An assessment of 66 joints for swelling and 68 joints for tenderness was made. Joints were assessed and classified as tender/not tender and swollen/not swollen by pressure and joint manipulation on physical examination. A smaller number indicated improvement.|Baseline, Week 96|Per-protocol population included all participants who had at least one dose of study medication and at least one safety evaluation after dose administration. Number of participants analyzed represent number of participants who were evaluable for the outcome measure.||units on a scale||Standard Deviation|Mean
665409|NCT01772316|Primary|Change From Baseline in Total Tender Joint Count (TJC) at Week 48|An assessment of 66 joints for swelling and 68 joints for tenderness was made. Joints were assessed and classified as tender/not tender and swollen/not swollen by pressure and joint manipulation on physical examination. A smaller number indicated improvement. Here, 'n' represents the number of participants with a measure at specified time point.|Baseline, Week 48|Per-protocol population included all participants who had at least one dose of study medication and at least one safety evaluation after dose administration. Number of participants analyzed represent number of participants who were evaluable for the outcome measure.||units on a scale||Standard Deviation|Mean
665410|NCT01772316|Primary|Change From Baseline in SDAI at Week 96|The SDAI was the numerical sum of five outcome parameter: SJC and TJC, PGA and IGA, and level of hsCRP. The index was calculated using the following formula SDAI = TJC28 + SJC28 + PGA + IGA + CRP. Change in SDAI = SDAI at Week 96 - SDAI at Baseline. SDAI total score = 0-86. SDAI <=3.3 indicates clinical remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high (or severe) disease activity.|Baseline, Week 96|Per-protocol population included all participants who had at least one dose of study medication and at least one safety evaluation after dose administration. Number of participants analyzed represent number of participants who were evaluable for the outcome measure.||units on a scale||Standard Deviation|Mean
665411|NCT01772316|Primary|Change From Baseline in Simplified Disease Activity Index (SDAI) at Week 48|The SDAI was the numerical sum of five outcome parameter: SJC and TJC, Patient Global Assessment of Disease Activity (PGA) and Investigator Global Assessment of Disease Activity (IGA), and level of hsCRP. The index was calculated using the following formula SDAI = TJC28 + SJC28 + PGA + IGA + CRP. Change in SDAI = SDAI at Week 48 - SDAI at Baseline. SDAI total score = 0-86. SDAI <=3.3 indicates clinical remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high (or severe) disease activity. Here, n signifies the number of subjects evaluable at the specified time points.|Baseline, Week 48|Per-protocol population included all participants who had at least one dose of study medication and at least one safety evaluation after dose administration. Number of participants analyzed represent number of participants who were evaluable for the outcome measure.||units on a scale||Standard Deviation|Mean
665412|NCT01772316|Primary|Change From Baseline in DAS28-ESR at Week 96|The DAS28 is a combined index for measuring disease activity in rheumatoid arthritis. The index included SJC, TJC, acute phase response (ESR or high sensitivity C-reactive protein [hsCRP]) and general health status. For this study, ESR was used to calculate DAS28 score. The index was calculated using the following formula: DAS28 = (0.56 × √[TJC28]) + (0.28 × √[SJC28]) + (0.7 × ln[ESR]) + (0.014 × GH). The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. Change in DAS28ESR=DAS28-ESR at Week 96 - DAS28-ESR at Baseline.|Baseline, Week 96|Per-protocol population included all participants who had at least one dose of study medication and at least one safety evaluation after dose administration. Number of participants analyzed represent number of participants who were evaluable for the outcome measure.||units on a scale||Standard Deviation|Mean
665413|NCT01772316|Primary|Change From Baseline in Disease Activity Score 28 - Erythrocyte Sedimentation Rate (DAS28-ESR) at Week 48|The DAS28 is a combined index for measuring disease activity in rheumatoid arthritis. The index included swollen joint count (SJC), tender joint count (TJC), acute phase response (ESR or high sensitivity C-reactive protein [hsCRP]) and general health status (GH). For this study, ESR was used to calculate DAS28 score. The index was calculated using the following formula: DAS28 = (0.56 × √[TJC 28]) + (0.28 × √[SJC 28]) + (0.7 × ln[ESR]) + (0.014 × GH). The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. Change in DAS28ESR=DAS28-ESR at Week 48 - DAS28-ESR at Baseline.|Baseline, Week 48|Per-protocol population included all participants who had at least one dose of study medication and at least one safety evaluation after dose administration. Number of participants analyzed represent number of participants who were evaluable for the outcome measure.||units on a scale||Standard Deviation|Mean
665414|NCT01772316|Primary|Percentage of Participants Withdrawn From the Study Due to Lack of Therapeutic Response||Baseline up to follow-up (Week 104)|Per-protocol population included all participants who had at least one dose of study medication and at least one safety evaluation after dose administration.||percentage of participants|||Number
665415|NCT01772316|Primary|Percentage of Participants With an Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a clinical investigation participant that was administered study drug, regardless of causal attribution.|Baseline up to follow-up (Week 104)|All participants receiving study drug were included in the safety analysis set.||percentage of participants|||Number
665416|NCT01772147|Secondary|Change From Baseline in the Mean Number of Puffs Per Day of Rescue Albuterol/Salbutamol Over Weeks 1-12|The mean number of puffs per day of rescue albuterol/salbutamol at Baseline and on-treatment was recorded. The total puffs of rescue albuterol/salbutamol for each day was calculated as: (number of puffs + [2 * number of nebules]). Baseline calculations include a period of the later of 27 days before Visit 2 and the day after Visit 1, up to and including Day 1. The Weeks 1-12 calculations include a period from Study Day 2 up to the earlier of Study Day 85 and the day before Visit 7. Change from Baseline was calculated as the Weeks 1-12 value minus the Baseline value. Analysis was performed using an analysis of covariance (ANCOVA) model with covariates of treatment, Baseline (mean during the 4 weeks prior to Day 1), and smoking status.|Baseline and Weeks1- 12|ITT Population. Only those participants available at the indicated time point were analyzed.||puffs||Standard Error|Least Squares Mean
665426|NCT01771965|Primary|Change in Treatment Engagement (Number of Participants Entering Treatment)|The investigators will be asking about service utilization since baseline interview. Zero = no mental health treatment and 1 = received mental health treatment.|30 days after baseline|Only 7 of the 10 control participants and 4 of the 9 intervention participants completed follow-up assessments.||Participants|||Count of Participants
665417|NCT01772147|Secondary|Change From Baseline in the Mean Percentage of Rescue-free Days Over Weeks 1-12|A rescue-free day is defined as a day on which no rescue medication was taken. Baseline calculations include a period of the later of 27 days before Visit 2 and the day after Visit 1, up to and including Day 1. The Weeks 1-12 calculations include a period from Study Day 2 up to the earlier of Study Day 85 and the day before Visit 7. Change from Baseline was calculated as the Weeks 1-12 value minus the Baseline value.|Baseline and Weeks 1- 12|ITT Population. Only those participants available at the indicated time point were analyzed.||Percentage of days||Standard Deviation|Mean
665418|NCT01772147|Secondary|Change From Baseline in Weighted Mean 0-6 Hour FEV1 Obtained Post-dose at Day 84|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The weighted mean FEV1 was derived by calculating the area under the curve, and then dividing the value by the relevant time interval. The weighted mean was calculated using the 6-hour serial FEV1 measurements at Day 84, which included pre-dose, and post-dose at 15 min, 30 min, 1 hour, 3 hours, and 6 hours. Baseline trough FEV1 is the mean of the two assessments made at -30 and -5 min pre-dose on Treatment Day 1. Change from Baseline was calculated as the Day 84 value minus the Baseline value. Analysis was performed using a repeated measures model with covariates of treatment, Baseline (mean of the two assessments made at -30and -5 min pre-dose on Treatment Day 1), smoking status, day, day by Baseline, and day by treatment interactions.|Baseline and Day 84|ITT Population. Only those participants available at the indicated time point were analyzed.||Liters||Standard Error|Least Squares Mean
665419|NCT01772147|Primary|Change From Baseline in the Trough Forced Expiratory Volume in One Second (FEV1) on Day 85|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Treatment Day 85 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Treatment Day 84 (i.e., at Week 12). Baseline trough FEV1 is the mean of the two assessments made at -30 and -5 minutes (min) pre-dose on Treatment Day 1. Change from Baseline was calculated as the Day 85 value minus the Baseline value. Analysis was performed using a repeated measures model with covariates of treatment, Baseline (mean of the two assessments made at -30 and -5 min pre-dose on Treatment Day 1), smoking status, day, day by Baseline, and day by treatment interactions.|Baseline and Day 85|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study medication in the Treatment Period. Only those participants available at the specified time points were analyzed.||Liters||Standard Error|Least Squares Mean
665420|NCT01772134|Secondary|Change From Baseline in the Mean Number of Puffs Per Day of Rescue Albuterol/Salbutamol Over Weeks 1-12|The mean number of puffs per day of rescue albuterol/salbutamol at Baseline and on-treatment was recorded. The total puffs of rescue albuterol/salbutamol for each day was calculated as: (number of puffs + [2 * number of nebules]). Baseline calculations include a period of the later of 27 days before Visit 2 and the day after Visit 1, up to and including Day 1. The Weeks 1-12 calculations include a period from Study Day 2 up to the earlier of Study Day 85 and the day before Visit 7. Change from Baseline was calculated as the Weeks 1-12 value value minus the Baseline value. Analysis was performed using an analysis of covariance (ANCOVA) model with covariates of treatment, Baseline (mean during the 4 weeks prior to Day 1), and smoking status.|Baseline and Weeks 1-12|ITT Population. Only those participants available at the indicated time point were analyzed.||puffs||Standard Error|Least Squares Mean
665421|NCT01772134|Secondary|Change From Baseline in the Mean Percentage of Rescue-free Days Over Weeks 1-12|A rescue-free day is defined as a day on which no rescue medication was taken. Baseline calculations include a period of the later of 27 days before Visit 2 and the day after Visit 1, up to and including Day 1. The Weeks 1-12 calculations include a period from Study Day 2 up to the earlier of Study Day 85 and the day before Visit 7. Change from Baseline was calculated as the Weeks 1-12 value minus the Baseline value.|Baseline and Weeks 1-12|ITT Population. Only those participants available at the indicated time point were analyzed.||Percentage of days||Standard Deviation|Mean
665422|NCT01772134|Secondary|Change From Baseline in Weighted Mean 0-6 Hour FEV1 Obtained Post-dose at Day 84|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The weighted mean FEV1 was derived by calculating the area under the curve, and then dividing the value by the relevant time interval. The weighted mean was calculated using the 24-hour serial FEV1 measurements at Day 84, which included pre-dose, and post-dose at 15 min, 30 min, 1 hour, 3 hours, and 6 hours. Baseline trough FEV1 is the mean of the two assessments made at -30 and -5 min pre-dose on Treatment Day 1. Change from Baseline was calculated as the Day 84 value minus the Baseline value. Analysis was performed using a repeated measures model with covariates of treatment, Baseline (mean of the two assessments made at -30and -5 min pre-dose on Treatment Day 1), smoking status, day, day by Baseline and day by treatment interactions.|Baseline and Day 84|ITT Population. Only those participants available at the indicated time point were analyzed.||Liters||Standard Error|Least Squares Mean
665423|NCT01772134|Primary|Change From Baseline in the Trough Forced Expiratory Volume in One Second (FEV1) on Day 85|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Treatment Day 85 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Treatment Day 84 (i.e., at Week 12). Baseline trough FEV1 is the mean of the two assessments made at -30 and -5 minutes (min) pre-dose on Treatment Day 1. Change from Baseline was calculated as the Day 85 value minus the Baseline value. Analysis was performed using a repeated measures model with covariates of treatment, Baseline (mean of the two assessments made at -30 and -5 min pre-dose on Treatment Day 1), smoking status, day, day by Baseline and day by treatment interactions.|Baseline and Day 85|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study medication in the Treatment Period. Only those participants available at the specified time points were analyzed.||Liters||Standard Error|Least Squares Mean
665424|NCT01771991|Secondary|Determine the Quality of Life Impact From Radiation Related Fibrosis in Head and Neck Cancer Patients|Metrics are measured via analysis of pain and range of motion and Health Related Quality of Life questionnaire.|3 months||||||
665425|NCT01771991|Primary|Improvement in Neck Fibrosis|Number of participants with improvement in fibrosis as defined as a one point improvement on the fibrosis scale using the grading scale outlined in CTCAE 4.03, page 46.|3 months|All subjects randomized between August 2012 and May 2013.||participants|||Number
665623|NCT01768013|Primary|Pharmacokinetic: Cmax of Calcipotriol|The mean Cmax (Maximum Observed Plasma Concentration) of calcipotriol was determined|Day 7|||pg/mL||Standard Deviation|Mean
665427|NCT01771913|Other Pre-specified|Number of Participants Experiencing Fat Necrosis in the Postoperative Period|Fat necrosis may occur whenever a fat graft is performed and it has clinical relevance. It can emerge as oil cysts or small nodules a little bit painful. In mammograms of normal breasts, fat necrosis present as cysts or micro calcifications that present a benign appearance. In breast reconstruction patients, fat necrosis, despite its benign characteristics, can suggest cancer recurrence.|up to 3 years|||participants|||Number
665428|NCT01771913|Secondary|Immunophenotyping|Immunophenotyping of the fresh stromal vascular fraction of both groups. Immunophenotyping or flow cytometry measures how many cells, in a sample, express a specific surface marker. A surface marker or a group of markers may characterize a specific cell type. The software that accompanies the flow cytometer determines the number of cells (in percentage) that express the tested surface marker.|baseline|we had technical problems in processing 4 tissue samples in each arm.||percentage of expression for CD90||Standard Deviation|Mean
665429|NCT01771913|Primary|Volume Maintenance|Volumetry of the reconstructed breasts will be accomplished through MRI and OsiriX software. Osirix software allows breast volume calculation through the determination of regions of interest (ROIs) on an MRI sequence. Once the pre (V1) and postoperative (V2) volumes were determined the following formula was applied: (V2 - V1) X 100/graft volume. The result, expressed in percentage, expresses graft volume persistence.|up to 1 year|||percentage of graft volume persistency||Standard Deviation|Mean
665430|NCT01771172|Primary|Subjects Will Demonstrate a Successful Defibrillation Outcome if They Have 2 Successful Defibrillation Shocks With the Research System.||within the first day|||percentage of success|||Number
665431|NCT01770860|Secondary|Subjective Assessment of Wound Healing|Until healed, subjects will be shown photographs of each wound they have not previously classified as healed at each daily visit, and asked to determine if the wound is healed. Yes or No responses will be recorded, along with text entries of the reasons for the response. This outcome measure reports the number of subjects who report that the wound has healed.|within 14 days|The Intent-to-Treat (ITT) population is defined as all subjects who received study bandages. One randomized subject withdrew from the study.||Participants|||Number
665432|NCT01770860|Secondary|Subjective Assessment of Itch|Until healed, itch assessments by the participant will be recorded daily for each wound site as either Present (P) or Absent (A). Percentage of itch was derived as the itch presence times over study period divided by visit number 13.|within 14 days|The Intent-to-Treat (ITT) population is defined as all subjects who received study bandages. One randomized subject withdrew from the study.||percentage of itching||Standard Deviation|Mean
665433|NCT01770860|Secondary|Subjective Assessment of Pain|Until healed, pain assessments by the participant will be recorded daily for each wound site as either Present (P) or Absent (A). Percentage of pain was derived as the pain presence times over study period divided by visit number 13.|within 14 days|The Intent-to-Treat (ITT) population is defined as all subjects who received study bandages. One randomized subject withdrew from the study.||percentage of pain||Standard Deviation|Mean
665434|NCT01770860|Secondary|Maceration|Until healed, maceration (a slight whitening of the skin around the wound compared to the surrounding unbandaged area) will be scored as P=Present or A=Absent. Percentage of maceration was derived as the maceration presence times over study period divided by visit number 13.|within 14 days|The Intent-to-Treat (ITT) population is defined as all subjects who received study bandages. One randomized subject withdrew from the study.||percentage of maceration||Standard Deviation|Mean
665435|NCT01770860|Secondary|Edema|Until healed, edema (swelling) of each wound bed and surrounding skin will be scored daily on a scale of 0-10, where 0=None and 10=Most severe. Mean Edema was evaluated at each visit. The mean score derived as total score divided by visit number 13 was analyzed using a mixed model.|within 14 days|The Intent-to-Treat (ITT) population is defined as all subjects who received study bandages. One randomized subject withdrew from the study.||scores on a scale||Standard Deviation|Mean
665436|NCT01770860|Secondary|Erythema|Until healed, erythema (redness) of each wound bed and surrounding skin will be scored daily on a scale of 0-10, where 0=None and 10=Most severe. Erythema was evaluated at each visit. The mean score derived as total score divided by visit number 13 was analyzed here using a mixed model.|within 14 days|The Intent-to-Treat (ITT) population is defined as all subjects who received study bandages. One randomized subject withdrew from the study.||scores on a scale||Standard Deviation|Mean
665437|NCT01770860|Secondary|Forced Rank Score|The wound evaluator will rank the overall appearance of all five wounds in relation to each other on a daily basis until all five are healed on a scale of 1 to 5, where 1= Worst and 5=Best. The forced Rank was evaluated at each visit. The mean score derived as total score divided by visit number 13 was analyzed using a mixed model.|within 14 days|The Intent-to-Treat (ITT) population is defined as all subjects who received study bandages. One randomized subject withdrew from the study.||scores on a scale||Standard Deviation|Mean
665438|NCT01770860|Primary|Time to Healing (Days)|Wound epithelialization will be recorded daily for each wound (until healed) by the doctor on a scale of 0-5, where 0= No presence of epithelialization (no sign of healing), a bandage is necessary and 5=Wound is 100% epithelialized (healed), no bandage necessary. The median time to healing will be estimated from the survival curves using the Kaplan-Meier method for each test product. Time to healing is defined as the time from wounding to 12:00 pm of the day the wound is 100% epithelialized (receives a score of 5). If the wound is not 100% epithelialized on Day 14 or on the last day of visit, Time to healing will be considered as censored.|within 14 days|The Intent-to-Treat (ITT) population is defined as all subjects who received study bandages. Forty six subjects were enrolled but one withdrew before randomization.||days||95% Confidence Interval|Median
665439|NCT01770743|Primary|Incidence of Immunologically Significant Adverse Events of Special Interest|Incidence of immunologically significant adverse events of special interest as defined by the Center for Biologics Evaluation and Research from the time of the first immunization on Day 0 through the 12-month safety follow-up telephone call following the last scheduled vaccination|From the time of the first immunization on Day 0 through the 12-month safety follow-up telephone call following the last scheduled vaccination|Safety Population (subjects who received at least one dose of IMP)||participants|||Number
665477|NCT01769612|Primary|Positive Result Comparison: CL Detect Rapid Test With Microscopy and Culture Results|"Comparison of CL Detect Rapid Test positive results with Microscopy and Culture results.
Note: only data where results for all three methods were available were included in the analysis."|within 1 hour after taking samples|||Participants|||Count of Participants
665440|NCT01770743|Primary|Incidence of Clinical Laborabory Abnormalities|"Incidence of clinical laboratory abnormalities throughout the study (up to Day 84).
Clinical laboratory abnormalities are presented as the total of Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), and Grade 4 (potentially life-threatening) abnormalities according to criteria adapted from the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research: Guidance for Industry. Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (September 2007). Within each laboratory parameter, subjects are counted once for their most severe occurrence of clinical laboratory abnormality."|From the time of first immunization on Day 0 to Day 84|Safety Population (subjects who received at least one dose of IMP)||participants|||Number
665441|NCT01770743|Primary|Incidence of Reactogenicity By Severity|"Incidence of solicited systemic reactions and solicited injection site reactions each day for 7 days following each vaccination using subject e-diaries by severity.
Reactions were graded using the following scale (note, for redness and swelling, the diameter [greater of two perpendicular measurements] was assessed by the subject using an injection site measurement tool):
Grade 0 (Absent): Symptom not present; Grade 1 (Mild): Symptom present but does not interfere with activities of daily living, or affected area (redness, swelling) measures <3 cm; Grade 2 (Moderate): Symptom causes some interference with activities of daily living, or affected area (redness, swelling) measures 3 – 10 cm; Grade 3 (Severe): Symptom prevents activities of daily living or requires treatment, or affected area (redness, swelling) measures > 10 cm.
For each reaction, subjects are counted once across all vaccinations at the highest reported level of severity."|For 7 days following each vaccination on Days 0, 14, 28|Safety Population (subjects who received at least one dose of IMP)||participants|||Number
665442|NCT01770743|Primary|Incidence of Serious Adverse Events|Incidence of serious adverse events, from the time of the first immunization on Day 0 through the 12-month safety follow-up telephone call following the last scheduled vaccination|From the time of the first immunization on Day 0 through the 12-month safety follow-up telephone call following the last scheduled vaccination|Safety Population (subjects who received at least one dose of IMP)||participants|||Number
665443|NCT01770743|Secondary|TNA Seroconversion Rate|Immunogenicity measured by the percentage of subjects who have seroconverted (defined as a 4-fold increase over Day 0 in TNA NF50 value) at Days 21, 28, 35, 42, 49, 63, and 84|Up to Day 84|Per-protocol Population at Day 63 (randomized subjects who did not have any deviation of 1) history of anthrax vaccination; 2) missing or out of window vaccination at Day 14 or 28; 3) incorrect IMP dose at one or more visits; 4) IMP dose associated with a temperature excursion; 5) prohibited medications; or 6) missing Day 63 immunogenicity data).||percentage of participants||95% Confidence Interval|Mean
665444|NCT01770743|Secondary|TNA Level at Day 28|Immunogenicity measured by the percentage of subjects with Day 28 TNA NF50 values greater than or equal to threshold|Day 28|Per-protocol Population at Day 63 (randomized subjects who did not have any deviation of 1) history of anthrax vaccination; 2) missing or out of window vaccination at Day 14 or 28; 3) incorrect IMP dose at one or more visits; 4) IMP dose associated with a temperature excursion; 5) prohibited medications; or 6) missing Day 63 immunogenicity data).||percentage of participants||95% Confidence Interval|Mean
665445|NCT01770743|Secondary|TNA Level at Day 42|Immunogenicity measured by the percentage of subjects in each study arm with Day 42 TNA NF50 values greater than or equal to threshold|Day 42|Per-protocol Population at Day 63 (randomized subjects who did not have any deviation of 1) history of anthrax vaccination; 2) missing or out of window vaccination at Day 14 or 28; 3) incorrect IMP dose at one or more visits; 4) IMP dose associated with a temperature excursion; 5) prohibited medications; or 6) missing Day 63 immunogenicity data).||percentage of participants||95% Confidence Interval|Mean
665446|NCT01770743|Primary|Incidence of Adverse Events|Incidence of adverse events (including assessment of symptoms, physical exam findings, clinical laboratory tests, and vital signs) from the time of the first immunization on Day 0 through Day 84|From the time of the first immunization on Day 0 through Day 84|Safety Population (subjects who received at least one dose of IMP)||participants|||Number
665447|NCT01770743|Primary|Toxin Neutralizing Antibody (TNA) Level at Day 63|Immunogenicity measured by the lower bound (LB) of the 95% confidence intervals (CIs) for the proportion of subjects in each study arm with Day 63 TNA 50% neutralization factor (NF50) values greater than or equal to threshold|Day 63|Per-protocol Population at Day 63 (randomized subjects who did not have any deviation of 1) history of anthrax vaccination; 2) missing or out of window vaccination at Day 14 or 28; 3) incorrect IMP dose at one or more visits; 4) IMP dose associated with a temperature excursion; 5) prohibited medications; or 6) missing Day 63 immunogenicity data).||percentage of participants||95% Confidence Interval|Mean
665448|NCT01770691|Primary|Mean Percentage of Pad Weight Gain (PWG) Change|"All eligible subjects underwent a 3-day Pad period to establish baseline Average PWG. During this period, pre-weighed pads were worn for 8 hours a day and subjects were asked to perform predefined physical activities and drink a certain amount of liquid, daily. Pads were collected and weighed in the clinic to determine baseline urine leakage. Subjects then used SMDs or the cleared TIPI (G3) with pads for up to 8 hours. The average PWG tests results with the TIPI devices were compared to the average PWG 8 hrs test without the device and were presented as percentages.
The efficacy endpoint for the study was mean percent change of PWG using a certain device compared to the values obtained at the baseline period, as calculated by the following formula:
% Reduction = 1-(Device/Baseline )*100
Where, Device = the average pad weight gain (PWG) during device usage. Baseline = the average pad weight gain (PWG) during the days of baseline period."|up to 8 hours of use|||Mean percentage of PWG change||Standard Deviation|Mean
665449|NCT01770652|Primary|Fe24 for Serum Deferiprone and Deferiprone 3-O-glucuronide|"Fe24 (fraction of dose excreted in urine from time zero to 24 hours) was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Urine samples were collected at the intervals of -2 to 0 hours pre-dose and 0 to 2, 2 to 4, 4 to 8, 8 to 12, and 12 to 24 hours post-dose.
Some of the Fe24 values were over 100% which could be explained by variability in urine collection (e.g. incomplete collection of urine into the container) and volume measurement, as well as analytical imprecision."|24-hour interval|The pharmacokinetic population included all subjects who had sufficient data to derive the value of at least one pharmacokinetic parameter||% of dose excreted in urine from 0-24 hr||Standard Deviation|Mean
665548|NCT01769222|Secondary|Immune Response (Phase 2 Only)|Data will be summarized using proportions with exact 95% confidence intervals, means, standard deviations, and ranges.|8 weeks||||||
665450|NCT01770652|Primary|Ae24 for Urine Deferiprone and Deferiprone 3-O-glucuronide|Ae24 (the amount excreted in urine from time zero to 24 hours) was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Urine samples were collected at the intervals of -2 to 0 hours pre-dose and 0 to 2, 2 to 4, 4 to 8, 8 to 12, and 12 to 24 hours post-dose.|24 hour interval|The pharmacokinetic population included all subjects who had sufficient data to derive the value of at least one pharmacokinetic parameter.||mg||Standard Deviation|Mean
665451|NCT01770652|Primary|T1/2 for Serum Deferiprone and Deferiprone 3-O-glucuronide|T1/2 was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained prior to dosing and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 9, 12, 16, and 24 hours post-dose.|24 hour interval|The pharmacokinetic population included all subjects who had sufficient data to derive the value of at least one pharmacokinetic parameter.||hour||Standard Deviation|Mean
665452|NCT01770652|Primary|AUC Zero to Infinity (AUC0-∞) for Serum Deferiprone and Deferiprone 3-O-glucuronide|AUC0-∞ was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained prior to dosing and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 9, 12, 16, and 24 hours post-dose.|24 hour interval|The pharmacokinetic population included all subjects who had sufficient data to derive the value of at least one pharmacokinetic parameter.||μg*h/mL||Standard Deviation|Mean
665453|NCT01770652|Primary|Tmax for Serum Deferiprone and Deferiprone 3-O-glucuronide|"Tmax was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained prior to dosing and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 9, 12, 16, and 24 hours post-dose.
The results of the Tmax parameter are reported as the median and range (other parameters are reported as mean and standard deviation)."|24 hour interval|The pharmacokinetic population included all subjects who had sufficient data to derive the value of at least one pharmacokinetic parameter.||hour||Full Range|Median
665454|NCT01770652|Secondary|Safety and Tolerability of Ferriprox® in Subjects With Renal Impairment.|The number of participants who experienced adverse events (including any changes of clinical significance in physical examinations, vital signs, 12-lead ECG, and clinical laboratory tests) following a single dose of Ferriprox.|From time of dosing until 72 hours post-dose|||participants|||Number
665455|NCT01770652|Primary|Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide|Cmax was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in subjects with normal, mild, moderate and severe renal impairment. Blood samples were obtained prior to dosing and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 9, 12, 16, and 24 hours post-dose.|24-hour interval|The pharmacokinetic population included all subjects who had sufficient data to derive the value of at least one pharmacokinetic parameter.||μg/mL||Standard Deviation|Mean
665456|NCT01770509|Secondary|Time to Complete Closure||4 weeks|Data was not collected as time to ulcer closure has been beyond the study period in the majority of patients|||||
665457|NCT01770509|Secondary|Incidence of Adverse Events|Number of adverse effects at 4 weeks|4 weeks|||number of adverse effects|||Number
665458|NCT01770509|Secondary|Incidence of Adverse Events at 4 Weeks|Number of patients with adverse effects at 4 weeks|4 weeks|||Number of patients with adverse events|||Number
665459|NCT01770509|Secondary|Alleviation of Pain|Pain in week 4, assessed by the patient on a visual analogue pain score from 0 to 10. 0 represents no pain, 10 represents worst pain|4 weeks|||units on a scale||Standard Deviation|Mean
665460|NCT01770509|Primary|Logarithm of Percentage of Baseline Ulcer Size|Logarithm of percentage of baseline ulcer size. Log (ulcer area at 4 weeks/ulcer area at baseline *100) Ulcer area measured as longest ulcer length x longest ulcer width|From start of treatment to 4 weeks|Analysis is based on measures from each ulcer, when some participants had more than one ulcer||Mean of log (percentage of baseline area|Ulcers|Standard Deviation|Mean
665461|NCT01770483|Secondary|Normalization of Alanine Transferase Test|Liver function test,showing resolution of the inflammation of liver parenchyma|48week|"Sample size has been calculated using Epi-Info 3.5.1 with the following assumptions.
Reported ETR with Interferon + Ribavarin = 44 % Expected ETR with Interferon + Ribavarin + Nitazoxanide = 80 % Confidence Level = 95 % Power of Study = 80% Calculated Sample Size = 66 i.e. 33 in each group."||participants|||Number
665462|NCT01770483|Primary|Sustained Viral Response,|Sustained viral response ,is negative Hepatitis C Virus(PCR)RNA test six months after end of treatment.|48 WEEK|"Sample size has been calculated using Epi-Info 3.5.1 with the following assumptions.
Reported ETR with Interferon + Ribavarin = 44 % Expected ETR with Interferon + Ribavarin + Nitazoxanide = 80 % Confidence Level = 95 % Power of Study = 80% Calculated Sample Size = 66 i.e. 33 in each group."||participants|||Number
665463|NCT01770431|Secondary|Postoperative Survival Period|Assess Postoperative survival period|Week 94 after took medicine|||weeks||Standard Error|Median
665464|NCT01770431|Primary|Incidence of Recurrence and Metastasis After Hepatectomy|At week 94 after took medicine, assess incidence of recurrence and metastasis after hepatectomy.|Week 94 after took medicine|||Participants|||Count of Participants
665465|NCT01770392|Secondary|Area Under the Curve From 0 to the Last Quantifiable Concentration (AUC0-tz)|"AUC0-tz represents the area under the plasma concentration-time curve of nintedanib from 0 to the last quantifiable analyte plasma concentration.
For this endpoint, the measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1.5 hour (h) before the first drug administration and 0.5h, 1h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after administration of nintedanib|TS||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
665466|NCT01770392|Primary|Maximum Measured Concentration (Cmax)|"Cmax represents the maximum concentration of nintedanib in plasma. For this endpoint, the measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1.5 hour (h) before the first drug administration and 0.5h, 1h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after administration of nintedanib|TS||ng/mL||Geometric Coefficient of Variation|Geometric Mean
665467|NCT01770392|Primary|Area Under the Curve From 0 Extrapolated to Infinity (AUC0-∞)|"AUC0-∞ represents the Area under the concentration-time curve of nintedanib in plasma over the time interval from 0 extrapolated to infinity.
For this endpoint, the measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1.5 hour (h) before the first drug administration and 0.5h, 1h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after administration of nintedanib|TS||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
665468|NCT01770379|Secondary|Percentage of Participants Achieving ACR50|"ACR50 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 50% improvement in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient’s assessment of RA pain, patient’s global assessment of disease activity, physician’s global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire [HAQ-DI] score), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR).
The ACR50 response results at week 24 used non-responder imputation."|Week 24|Full analysis set: the full analysis set was comprised of all randomized participants (excluding mis-randomized participants) who were assigned to study treatment||Percentage of patients|||Number
665469|NCT01770379|Secondary|Change From Baseline in Stanford Health Assessment Questionnaire Disability Index (HAQ-DI)|"The HAQ-DI assesses a subject's level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities. There are 20 questions in 8 categories of functioning including dressing, rising, eating, walking, hygiene, reach, grip and usual activities. The stem of each item asks 'Over the past week, are you able to... perform a particular task'. Each item is scored on a 4 point scale from 0 - 3, representing normal, no difficulty (0), some difficulty (1), much difficulty (2) and unable to do (3). The disability index score is calculated as the mean of the available category scores, ranging from 0 to 3. A negative change from baseline indicates improvement."|Week 24|Full analysis set (FAS): The FAS was comprised of all patients from the randomized set to whom study treatment had been assigned.||units on a scale||Standard Error|Least Squares Mean
665470|NCT01770379|Secondary|Change From Baseline in Disease Activity Score Utilizing CRP (DAS28-CRP)|The DAS28 is a measure of disease activity in RA based on Swollen and Tender Joint Counts (out of a total of 28), hsCRP and the Patient’s Global Assessment of Disease Activity. A DAS28 score greater than 5.1 implies active disease, equal to or less than 3.2 low disease activity, and less than 2.6 remission. A negative change from baseline indicates improvement.|Week 24|Full analysis set (FAS): The FAS was comprised of all patients from the randomized set to whom study treatment had been assigned.||Units on a scale||Standard Error|Least Squares Mean
665471|NCT01770379|Primary|Percentage of Participants Achieving an American College of Rheumatology Response 20 (ACR20).|"ACR20 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 20% improvement in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient’s assessment of RA pain, patient’s global assessment of disease activity, physician’s global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire [HAQ-DI] score), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR).
The ACR20 response results at week 24 used non-responder imputation."|Week 24|Full analysis set (FAS): The FAS was comprised of all patients from the randomized set to whom study treatment had been assigned.||percentage of participants|||Number
665472|NCT01770366|Primary|BMI||3 months post surgery|||kg/m2||Standard Deviation|Mean
665473|NCT01770314|Secondary|Satisfaction With the Program|"We tested and analyzed participants' satisfaction with the program by asking the question: Overall, how satisfied were you with the lessons. They answered on a 4 point Likert scale: 1=Not at all satisfied, 2=Somewhat Satisfied, 3=Satisfied, 4 = Very satisfied. Higher values indicate higher satisfaction."|One-month followup assessment|We only analyzed satisfaction data for experimental participants who had indicated that they disposed of their unused opioid medications (n=17)||units on a scale||Standard Deviation|Mean
665474|NCT01770314|Primary|Self-efficacy - 8 Item Measure Taps Into Key Concepts Associated With Confidence for Managing Opioid Medications|"Responses are measured on a 4-point Likert scale (1= Not at all confident and 4= Extremely confident). The total Score range:8=least confident, 32=most confident.
How confident do you feel in your ability to do each of the following activities, today?
I can recognize side effects that are related to my opioid medicine.
I can avoid giving my opioid medicine to someone else. Etc.. 1 - Not at all confident 2 - Somewhat confident 3 - Very confident 4 - Extremely confident Items have been generated from literature. Content validity: assessed by asking two experts if items are important and relevant.
Internal consistency of the items in the pilot measure will be assessed (Cronbach’s alpha).
Test-retest reliability will be explored by asking 50 participants in the control group to retake the pilot measure within 3-5 days of having taken the measure as part of the pretest."|Baseline - Day 1, Posttest - Day 16 (intervention took 15 days), One month Followup - at 1 month post-intervention|||units on a scale||Standard Error|Least Squares Mean
665475|NCT01770145|Secondary|Change From Baseline in Gastric Emptying Time|A sub-group of subjects from 1 study site that have symptoms of gastroparesis were admitted to the clinic on 2 occasions to undergo gastroparesis procedures and assessments (once at the conclusion of the baseline L-dopa period and once at the conclusion of the APOKYN treatment period). Note, to do the second gastroparesis assessment, this sub-group of subjects had an extension for one extra day beyond the designated 7 day APOKYN treatment period (i.e., it will be 8 days) in order to keep the 7 day diary recording outpatient scope of work the same as the rest of the subjects in the study. The second inpatient period was also considered the end-of-study visit for this sub group.|L-Dopa Baseline Days 1-7 and APOKYN Treatment Days 1-8|A sub-group of subjects from 1 study site that have symptoms of gastroparesis were admitted to the clinic to undergo gastroparesis procedures and assessments (once at the conclusion of the baseline L-dopa period and once at the conclusion of the APOKYN treatment period)|||||
665476|NCT01770145|Primary|"Change From Baseline in Average Daily Time to on (TTO) by Subject Diary."|"Patients will record daily time to on or TTO following their regularly scheduled first L-Dopa dose in the baseline period for 7 consecutive days. Following initiation on Apokyn therapy, patients will inject Apokyn at their regularly scheduled L-Dopa time (L-Dopa dosing will be delayed by 40 minutes following Apokyn injection) and record time to on or TTO from the injection. Time to on for both periods will be recorded in a standardized subject diary. Daily TTO for the baseline period will be averaged for each subject and compared to the daily TTO for the same subject during the treatment period to assess APOKYN's effect on TTO."|L-Dopa Baseline Days 1-7 and APOKYN Treatment Days 1-7|||minutes||Standard Deviation|Mean
665549|NCT01769222|Secondary|Immune Response (Phase 2 Only)|Data will be summarized using proportions with exact 95% confidence intervals, means, standard deviations, and ranges.|4 weeks||||||
665478|NCT01769586|Primary|Number of Patients Who Achieve Adequate Sedation to Allow Colonoscopy (Defined as MOAA/S ≤3)|Modified Observer’s Assessment of Alertness/Sedation (MOAA/S) scale. This scale ranges from 0 to 5, where 0 denotes general anesthesia, in which the patient has no response to painful stimuli, and 5 denotes a level of minimal sedation in which the patient is fully awake.|Approximately 10 minutes or less|||participants|||Number
665479|NCT01769508|Secondary|Overall Survival (OS)|The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death|18 months|||months||95% Confidence Interval|Median
665480|NCT01769508|Secondary|Time to Progression (TTP)|Time to progression is defined as the time between day 1 cycle 1 and time to first documented disease progression. Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|18 months|||months||95% Confidence Interval|Median
665481|NCT01769508|Secondary|Toxicity Profile for Treated Patients|Defined as the frequency of adverse events for patients who received at least one dose of study treatment, and assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0.|18 months|All treated patients||participants|||Number
665482|NCT01769508|Secondary|Progression Free Survival (PFS)|The Percentage of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|18 months|||months||95% Confidence Interval|Median
665483|NCT01769508|Primary|Safety and Optimal Dose of Regimen|An additional primary objective is to evaluate the safety and optimal dose of lapatinib when added to 5-FU, oxaliplatin and radiation therapy.|18 months|||mg QD Lapatinib|||Number
665484|NCT01769508|Primary|Pathologic Complete Response Rate (pCR Rate)|Defined as the absence of invasive tumor in esophagogastric and lymph node tissue removed at time of surgery, as judged by the local pathologist. An improvement in pCR rate from 30 percent (historical) to 50 percent is the primary efficacy endpoint.|18 months|All patients who underwent surgery||participants|||Number
665485|NCT01769443|Secondary|Incidence of Rejection Episodes Per Subject and Freedom From Rejection|"Rejection is defined as follows:
Biopsy proven acute rejection (BPAR) of any grade (cellular rejection per 2004 ISHLT [International Society of Heart and Lung Transplantation] grading scale),
BPAR (individual grades),
BPAR (Biopsy Proven Acute Rejection) > 2R
antibody mediated rejection (AMR),
Any treated rejection,
Rejection associated with hemodynamic compromise (HDC)."|24 and 52 weeks post-transplantation|No analyses were performed due to slow enrollment and early study closure.|||||
665486|NCT01769443|Secondary|Incidence of Hospitalizations||24 and 52 weeks post-transplantation|No analyses were performed due to slow enrollment and early study closure.|||||
665487|NCT01769443|Secondary|Re-transplantation or Re-listed for Transplantation||24 and 52 weeks post-transplantation|No analyses were performed due to slow enrollment and early study closure.|||||
665488|NCT01769443|Secondary|Death||24 and 52 weeks post-transplantation|No analyses were performed due to slow enrollment and early study closure.|||||
665489|NCT01769443|Secondary|Incidence of Post-Transplant Lymphoproliferative Disorder (PTLD)||24 and 52 weeks post-transplantation|No analyses were performed due to slow enrollment and early study closure.|||||
665490|NCT01769443|Secondary|Cardiac Dysfunction as Reflected in the Left Ventricular Ejection Fractions < 40% by Echocardiography, Angiogram or Nuclear Testing.||24 and 52 weeks:|No analyses were performed due to slow enrollment and early study closure.|||||
665491|NCT01769443|Secondary|Number of Subjects on Left Ventricular Assist Devices (LVAD) Compared to Those Not on LVADs||24 and 52 weeks post-transplantation|No analyses were performed due to slow enrollment and early study closure.|||||
665492|NCT01769443|Secondary|Incidence of Serious Infections Requiring Intravenous Antimicrobial Therapy||24 and 52 weeks post-transplantation|No analyses were performed due to slow enrollment and early study closure.|||||
665493|NCT01769443|Secondary|Development of Angiographically Evident Cardiac Allograft Vasculopathy at 1 Year||24 and 52 weeks post-transplantation|No analyses were performed due to slow enrollment and early study closure.|||||
665494|NCT01769443|Secondary|Incidence of Administering Desensitization Therapy Beyond 90 Days After Randomization||At transplant, or 1 year post-randomization, whichever occurs first|No analyses were performed due to slow enrollment and early study closure.|||||
665495|NCT01769443|Secondary|Incidence of Acute Renal Failure Requiring Hemodialysis||At transplant, or 1 year post-randomization, whichever occurs first|No analyses were performed due to slow enrollment and early study closure.|||||
665496|NCT01769443|Secondary|Incidence of Cerebral Vascular Accident||At transplant, or 1 year post-randomization, whichever occurs first|No analyses were performed due to slow enrollment and early study closure.|||||
665497|NCT01769443|Secondary|Incidence of Severe Infection Requiring Intravenous Antibiotics||At transplant, or 1 year post-randomization, whichever occurs first|No analyses were performed due to slow enrollment and early study closure.|||||
665498|NCT01769443|Secondary|Incidence of Initiation of Any Mechanical Circulatory Support Device||At transplant, or 1 year post-randomization, whichever occurs first|No analyses were performed due to slow enrollment and early study closure.|||||
665499|NCT01769443|Secondary|Incidence of Removal From Transplant Waiting List for Any Reason Except Improvement of Cardiac Function||At transplant, or 1 year post-randomization, whichever occurs first|No analyses were performed due to slow enrollment and early study closure.|||||
665500|NCT01769443|Secondary|Incidence of Death||At transplant, or 1 year post-randomization, whichever occurs first|No analyses were performed due to slow enrollment and early study closure.|||||
665501|NCT01769443|Secondary|Change in Calculated PRA (cPRA) From Wait Listing to Transplantation||At transplant, or 1 year post-randomization, whichever occurs first|No analyses were performed due to slow enrollment and early study closure.|||||
665502|NCT01769443|Secondary|Time From Wait Listing to Heart Transplantation||At transplant, or 1 year post-randomization, whichever occurs first|No analyses were performed due to slow enrollment and early study closure.|||||
665550|NCT01769222|Primary|Dose-limiting Toxicity|Safety as the percentage of patients experiencing dose-limiting toxicities (DLTs) or serious adverse events (SAEs) using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase I)|4 weeks|||percentage of participants|||Number
665503|NCT01769443|Primary|Composite of Incidence of the Following Events in Subjects|"Death,
Removal from the transplant waiting list for any reason except improvement of cardiac function,
Initiation of any mechanical circulatory support device,
Severe infection requiring intravenous antibiotics,
Cerebral vascular accident,
Acute renal failure requiring dialysis."|At transplant, or 90 days post-randomization, whichever occurs first|No analyses were performed due to slow enrollment and early study closure.|||||
665504|NCT01769391|Secondary|Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab||Cycle 1, Day 8 ; Cycle 2, Day 1; Cycle 3, Day 1;Cycle 4, Day1;Cycle 5, Day 1; Cycle 6, Day 1 (within 2 hours prior to beginning of infusion)|All participants who received at least one dose of study drug and had evaluable PK data.||nanogram/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
665505|NCT01769391|Secondary|Percent Change in Tumor Size (CTS)|CTS is defined as maximum percent change from baseline in the sum of target lesions.|Baseline to Progressive Disease or Death (Up to 24 Months)|All randomized participants who received at least 1 dose of study drug and who had a decrease from baseline in the sum of target lesions.||percent change in tumor size||Standard Deviation|Mean
665506|NCT01769391|Secondary|Percentage of Participants Who Achieve Best Overall Disease Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD) (Disease Control Rate [DCR])|Defined using the same denominator as defined in ORR. Among participants counted in the denominator, the numerator counts those with a confirmed best tumor response of SD, PR, or CR per RECIST 1.1. (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; PR at least 30% decrease in the sum of diameter of target lesions; CR: disappearance of all target lesions).|Baseline to Progressive Disease and/or Death (Estimated up to 24 Months)|All randomized participants who received at least 1 dose of study drug and who had a complete radiographic assessment.||percentage of participants||95% Confidence Interval|Number
665507|NCT01769391|Secondary|Progression-Free Survival|Progression-Free Survival (PFS) is defined as the time from randomization until the first radiographically documented progressive disease (PD) or death from any cause. PD defined by Response Evaluation Criteria in Solid Tumors Criteria (RECIST version 1.1) as at least a 20% increase in the sum of the diameters of target lesions,taking as reference the smallest sum on study (including the baseline sum if that is the smallest). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. For participants not known to have died as of the data cut-off date and who do not have objective PD, PFS will be censored at the date of the last complete radiographic assessment.|Randomization to Progressive Disease or Death (Up to 24 Months)|All randomized participants; with 15 and 7 censored participants in Paclitaxel +Carboplatin + Necitumumab and Paclitaxel +Carboplatin Arms, respectively.||months||95% Confidence Interval|Median
665508|NCT01769391|Secondary|Percentage of Participants With Anti Necitumumab Antibodies||Baseline to End of Cycle 6|All participants who received any amount of necitumumab and had post baseline antibody data.||percentage of participants|||Number
665509|NCT01769391|Secondary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of Necitumumab||Pre-infusion Cycle 1, Day 1; Cycle 3, Day 1; Cycle 5; Day 1 (within 2 hours prior to beginning of infusion)|All participants who received at least one dose of necitumumab and had evaluable PK data.||microgram/milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
665510|NCT01769391|Secondary|Overall Survival (OS)|OS defined as the time from the date of randomization to the date of death from any cause. For participants not known to have died as of the data cut-off date, OS was censored at the last contact date (last contact for participants in post-discontinuation = last known alive date in mortality status).|Randomization to Date of Death (Up to 24 Months)|All randomized participants; (49 and 19 censored participants in Paclitaxel + Carboplatin + Necitumumab and Paclitaxel + Carboplatin Arms, respectively.||months||95% Confidence Interval|Median
665511|NCT01769391|Primary|Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) (Objective Response Rates [ORR])|The denominator of ORR (Objective Response Rate) includes each participant enrolled who received any amount of study drug (necitumumab, gemcitabine, and/or cisplatin), and who had a complete radiographic assessment at baseline and at least one complete radiographic assessment post-baseline. The numerator includes those participants counted in the denominator with a confirmed best overall tumor response of partial or complete response (Complete Response (CR): disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 millimeters (mm). Partial Response (PR): at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter.) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.|Baseline to Disease Progression or Death (Up to 24 Months)|All randomized participants that received at least 1 dose of study drug, who had a complete radiographic assessment at baseline and at least 1 complete radiographic assessment post-baseline.||percentage of participants||95% Confidence Interval|Number
665512|NCT01769378|Secondary|Change From Baseline in Amylase|A summary of changes in amylase evaluation from baseline to endpoint.|Baseline, 24 Weeks|Participants who received at least one dose of study drug and had evaluable amylase data at both baseline and post-baseline. LOCF was used to impute missing postbaseline values. If no data after date of randomization, the endpoint was considered missing.||Units/Liter||Inter-Quartile Range|Median
665513|NCT01769378|Secondary|Change From Baseline in Lipase|A summary of changes in lipase evaluation from baseline to endpoint.|Baseline, 24 Weeks|All participants who received at least one dose of study drug and had evaluable lipase data at both baseline and post-baseline. LOCF was used to impute missing postbaseline values. If no data after date of randomization, the endpoint was considered missing.||Units/Liter||Inter-Quartile Range|Median
665514|NCT01769378|Secondary|Dulaglutide Anti-Drug Antibodies (ADA)|Number of participants with treatment emergent (TE) dulaglutide anti-drug antibodies from postbaseline to follow up were summarized. A participant is considered to have TE dulaglutide ADA if the participant has at least one titer that is treatment-emergent relative to baseline, defined as a 4-fold or greater increase in titer from baseline measurement.|Baseline up to 4 Weeks Post-Last Dose of Study Drug|ITT population: all randomized participants who received at least one dose of study drug.||participants|||Number
665591|NCT01768325|Secondary|Overall Specimen Length||36 months|||mm||Standard Deviation|Mean
665624|NCT01768013|Primary|Pharmacokinetic: Cmax of Calcipotriol|The mean Cmax (Maximum Observed Plasma Concentration) of calcipotriol was determined|Day 1|||pg/mL||Standard Deviation|Mean
665515|NCT01769378|Secondary|Time to Initiation of Additional Intervention for Severe, Persistent Hyperglycemia|An additional intervention (rescue therapy) was defined as any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation. Participants who had no rescue therapy within specified study period were considered as censored observations at the last available contact date up to specified study period.|Baseline through 24 Weeks|ITT population: All randomized participants who received at least one dose of study drug.||weeks||Standard Error|Mean
665516|NCT01769378|Secondary|Percentage of Participants Requiring Additional Intervention for Severe, Persistent Hyperglycemia|Additional Intervention: any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation.|Baseline through 24 Weeks|ITT population: all randomized participants who received at least one dose of study drug.||percentage of participants|||Number
665517|NCT01769378|Secondary|Rate of HE Adjusted Per 30 Days|The hypoglycemia rate per 30 days during defined period is calculated by the number of hypoglycemia events within the period/number of days participant at risk within the period*30 days.|Baseline through 24 weeks|ITT population: all randomized participants who received at least one dose of study drug.||number of events/participants/30 days||Standard Deviation|Mean
665518|NCT01769378|Secondary|Percentage of Participants With Self-Reported Events of Hypoglycemia|Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of =<3.9 mmol/L), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of =<3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). Percentage is calculated as the number of participants reporting HE each visit/ the total number of participants reporting HE during the entire study treatment period.|Baseline through 24 Weeks|ITT Population: all randomized participants who received at least one dose of study drug.||percentage of participants|||Number
665519|NCT01769378|Secondary|Change From Baseline in Calcitonin at 24 Weeks||Baseline, 24 Weeks|Participants who received at least one dose of study drug and evaluable calcitonin data at baseline and post-baseline.||picogram per milliliter (pg/ml)||Inter-Quartile Range|Median
665520|NCT01769378|Secondary|Number of Participants With Adjudicated Acute Pancreatitis Events|The number of participants with pancreatitis confirmed by adjudication is summarized cumulatively at 24 weeks plus 30-day follow up. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 24 Weeks, 30-day Follow Up|ITT population: all randomized participants who received at least one dose of study drug.||participants|||Number
665521|NCT01769378|Secondary|Number of Participants With Reported and Adjudicated Cardiovascular Events|Information on cardiovascular (CV) risk factors was collected at baseline. Deaths and nonfatal cardiovascular adverse events (AEs) were adjudicated by an external committee of physicians with cardiology expertise. Nonfatal cardiovascular AEs to be adjudicated included myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions, and cerebrovascular events, including cerebrovascular accident (stroke) and transient ischemic attack. The number of participants with CV events confirmed by adjudication is summarized cumulatively at 24 weeks plus 30-day follow up. Serious and all other non-serious adverse events regardless of causality are summarized in the Reported Adverse Events module.|Baseline through 24 Weeks, 30-day Follow Up|ITT population: All randomized participants who received at least one dose of study drug.||participants|||Number
665522|NCT01769378|Secondary|Change From Baseline in Mean of All 7-Point Self Monitored Plasma Glucose (SMPG) at 24 Weeks|LS Means of the SMPG change from baseline to primary endpoint at week 24 was adjusted by fixed effects of treatment, country, visit, treatment-by-visit interaction, participant as random effect and baseline SMPG value as covariate, via a MMRM analysis using REML.|Baseline, 24 Weeks|Participants who received at least one dose of study drug and had evaluable SMPG data at both baseline and post-baseline.||mg/dL||Standard Error|Least Squares Mean
665523|NCT01769378|Secondary|Change From Baseline in Body Mass Index (BMI) at 24 Weeks|LS Means of the BMI change from baseline to primary endpoint was adjusted by fixed effects of treatment, country, visit, treatment-by-visit interaction, participant as random effect and baseline BMI as covariate, via a MMRM analysis using REML.|Baseline, 24 Weeks|Participants who received at least one dose of study drug and evaluable BMI data at both baseline and post-baseline.||kilograms per/square meter kg/m^2||Standard Error|Least Squares Mean
665524|NCT01769378|Secondary|Change From Baseline in Body Weight at 24 Weeks|LS Means of the body weight change from baseline to primary endpoint was adjusted by fixed effects of treatment, country, visit, treatment-by-visit interaction, participant as random effect and baseline body weight as covariate, via a MMRM analysis using REML.|Baseline, 24 Weeks|Participants who received at least one dose of study drug and had evaluable body weight data at both baseline and post-baseline.||kilograms (kg)||Standard Error|Least Squares Mean
665525|NCT01769378|Secondary|Change From Baseline in Fasting Serum Glucose (FSG) at 24 Weeks|LS Means of the FSG from baseline to primary endpoint was adjusted by fixed effects of treatment, country, baseline HbA1c strata, and baseline FSG as covariate, via Analysis of Covariance Model (ANCOVA) with Last Observation Carried Forward (LOCF).|Baseline, 24 Weeks|Participants who received at least one dose of study drug and had evaluable FSG data at both baseline and post-baseline. LOCF was used to impute missing post-baseline values. If no data after date of randomization, the endpoint was considered missing.||milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
665526|NCT01769378|Secondary|Percentage of Participants Who Achieve HbA1c <7.0% and ≤6.5% at 24 Weeks|The percentage of participants who achieved the target HbA1c values at endpoint will be analyzed with a repeated logistic regression model (the generalized estimation equation [GEE] model). The model includes country, treatment, visit and treatment interaction and baseline HbA1c as a continuous covariate.|24 Weeks|Participants who were randomized and received at least one dose of study drug with evaluable HbA1c data.||percentage of participants|||Number
665527|NCT01769378|Primary|Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at 24 Weeks|Least Squares Means (LS Means) of the HbA1c change from baseline to primary endpoint was adjusted by fixed effects of treatment, country, visit, treatment-by-visit interaction, participant as random effect and baseline HbA1c as covariate, via a Mixed-effects model for repeated measures (MMRM) analysis using restricted maximum likelihood (REML).|Baseline, 24 Weeks|Participants who were randomized and received at least one dose of study drug with evaluable HbA1c data at both baseline and post-baseline.||percent change of HbA1c||Standard Error|Least Squares Mean
665528|NCT01769365|Primary|Eradication|Evaluate eradication outcome by endoscopy urease test and histology or urea breath test|at the 6th week after the end of anti- H. pylori therapy|||participants|||Number
665529|NCT01769352|Secondary|Mean Change in Intraocular Pressure Between Week 12 and Week 24|Mean Change in Intraocular Pressure (IOP) between week 12 and week 24|Week 12 and Week 48|||mmHg||Standard Error|Mean
665530|NCT01769352|Secondary|Mean Change in Central Subfield Thickness (CST) Between Week 12 and Week 48|Mean Change in Central Subfield Thickness (CST,µm) between week 12 and week 48|Week 12 and Week 48|||µm||Standard Error|Mean
665531|NCT01769352|Secondary|Mean Change in Best-Corrected Visual Acuity Between Week 12 and Week 48|Mean Change in Best-Corrected Visual Acuity (Letters Score) between Week 12 and Week 48. The Early Treatment of Diabetic Retinopathy Study (ETDRS) score is measured on a scale from 5 to 100. The higher the score on this scale, the better is the patients vision.|Week 12 and Week 48|||Letters||Standard Error|Mean
665532|NCT01769352|Secondary|Mean Change in Intraocular Pressure at Week 12 From Baseline|Mean Change in Intraocular Pressure (IOP) at week 12 from Baseline|Baseline and Week 12|||mmHg||Standard Error|Mean
665533|NCT01769352|Secondary|Mean Change in Central Subfield Thickness at Week 12 From Baseline|Mean Change in Central Subfield Thickness (µm) at Week 12 from Baseline|Baseline and Week 12|||µm||Standard Error|Mean
665534|NCT01769352|Primary|Mean Change in Best-Corrected Visual Acuity at Week 12 From Baseline|Mean change in best-corrected visual acuity (Letter Score) at Week 12 from Baseline. The Early Treatment of Diabetic Retinopathy Study (ETDRS) score is measured on a scale from 5 to 100. The higher the score on this scale, the better is the patients vision.|Baseline and Week 12|||letters||Standard Error|Mean
665535|NCT01769339|Secondary|Pruritus Symptom Assessment by Visual Analog Scale (VAS) Score|Pruritus is assessed by using a 100 millimeter (mm) of VAS score ranges from 0 to 100 mm, where 0 mm=no pruritus and 100 mm=worse pruritus.|1-hour after initial application|Data was not collected as only few participants had pruritus after 1-hour of study drug application.|||||
665536|NCT01769339|Secondary|Modified Itch Severity Scale (MISS) Score|The MISS is a specific instrument for assessing and quantifying the intensity of pruritus. The MISS score ranges from 0 to 21, where 0=no itching and 21=very severe itching.|Baseline and Day 28|Analysis Population included all the participants who received at least 1 dose of study medication. Here ‘n’ signifies those participants who were evaluable at specified time-point.||units on a scale||Standard Deviation|Mean
665537|NCT01769339|Secondary|Percentage of Participants Who Achieved Clinical Cure|Participants were considered as clinically cured if the potassium hydroxide (KOH) mount / Gram stain (a method used to diagnose bacterial infection) test was negative for infection.|Baseline up to Day 28|Analysis population included all the participants who received at least 1 dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||percentage of participants|||Number
665538|NCT01769339|Primary|Mean Time to Itch Relief|Time to itch relief is defined as time needed to achieve pruritus (itchiness) relief.|1-hour after initial application|Analysis population included all the participants who received at least 1 dose of study medication.||minutes||Standard Error|Mean
665539|NCT01769326|Other Pre-specified|Range of Motion of Shoulder Joint||1 month||||||
665540|NCT01769326|Primary|Motor and Strength Outcome Measure Using Fugl-Meyer Score|The primary outcome measure was the change in Upper Extremity FM score on a scale of 0 to 66 at one month post therapy. The higher the scores, the better arm and hand function indicated.|From baseline to 1 month post therapy|Fugl-Meyer score at one month post therapy minus Fugl-Meyer score at baseline on a 66 point scale. Please note that Fugl-Meyer UE motor score is the primary outcome measure for RAE part of the study.||units on a scale||Standard Deviation|Mean
665541|NCT01769326|Primary|Motor and Strength Outcome Measure Using Box and Block Test|The primary end point was the change in Box and Blocks score, which measures how many blocks a subject can pick up and place in a box in 60 secons, from baseline to 1 month posttherapy. The higher the scores, the better arm and hand function indicated.|From baseline to 1 month post therapy|Number of blocks participants able to pick up and place in a box in 60 seconds at one month follow up minus the number of blocks participants able to pick up and place in a box in 60 seconds at baseline. Please note that box and block test was the primary outcome measure for the Music Glove part of the study.||blocks||Standard Deviation|Mean
665542|NCT01769248|Secondary|Percentage of Patients in Whom a Diagnosis is Acheived After Crossover (%)|As above. Crossover to FNA or FNB occurs after 3 passes without adequate material|1 yr||||||
665543|NCT01769248|Secondary|Specimen Adequacy as Assessed by Rapid-onsite Evaluation of FNA and FNB|The investigators' secondary outcome will assess the ability to obtain an adequate specimen for in room cytologic evaluation as determined by our cytopathologist. This will be defined as a sample that is representative (not necessarily diagnostic) of the lesion in question. This will be expressed as a percentage and compared between FNA and FNB|1 year||||||
665544|NCT01769248|Primary|Diagnostic Yield of EUS-FNB|The investigators' primary outcome measure will assess the diagnostic yield (percentage of patients with a diagnosis) of EUS-FNB (fine-needle biopsy) to provide a final diagnosis of the lesion being sampled. This will be expressed as a percentage.|1 year|||percentage of patients|||Number
665545|NCT01769222|Secondary|Duration of Response (Phase 2 Only)|Data will be summarized using Kaplan-Meier estimates for time to event data.|Up to 5 years||||||
665546|NCT01769222|Secondary|Overall Survival (Phase 2 Only)|Data will be summarized using Kaplan-Meier estimates for time to event data.|Up to 5 years||||||
665547|NCT01769222|Secondary|Response Rate (Phase 2 Only)|Response rates calculated based on the Response Evaluation Criteria in Solid Tumors (RECIST)/RECIST Immunotherapy and Cheson criteria (Phase 2 only). Response rate data will be summarized using proportions with exact 95% confidence intervals, means, standard deviations, and ranges.|8 weeks||01/2017||||
665551|NCT01769196|Secondary|Absolute Change From Baseline in St. George’s Respiratory Questionnaire (SGRQ) Score|"The SGRQ is a disease-specific questionnaire designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Patients respond to questions about symptoms (frequency & severity) and impact components (social functioning and psychological disturbances resulting from airways disease). Scores range from 0 to 100, with higher scores indicating more limitations.
The absolute change was calculated as value at later time point minus value at baseline, with lower values indicating a decrease and higher values indicating an increase."|Week 58, 106, and 130|Participants in the ITT Analysis Set with available data were analyzed. Any participant with available outcome data on baseline or post-baseline was included in the MMRM model, thus all 272 participants in each of the two treatment groups were included in this analysis.||units on a scale||Standard Error|Least Squares Mean
665552|NCT01769196|Secondary|Absolute Change From Baseline in 6 Minute Walk Distance (6MWD)|"Adjusted means were from MMRM model with baseline 6MWD, FVC % predicted, sLOXL2 level, concomitant pirfenidone/nintedanib use (never vs. ever), treatment, visit, and treatment-by-visit interaction terms, including all data up to Week 130.
The absolute change was calculated as value at later time point minus value at baseline, with lower values indicating a decrease and higher values indicating an increase."|Weeks 58, 106, and 130|Participants in the ITT Analysis Set with available data were analyzed. Any participant with available outcome data on baseline or post-baseline was included in the MMRM model, thus all 272 participants in each of the two treatment groups were included in this analysis.||Meters||Standard Error|Least Squares Mean
665553|NCT01769196|Secondary|Number of Participants Experiencing Adjudicated Respiratory Deaths Among Those With Adjudicated Death||Up to 148 weeks|Participants in the ITT Analysis Set with adjudicated deaths were analyzed.||Participants|||Count of Participants
665554|NCT01769196|Secondary|Number of Adjudicated Respiratory Hospitalizations (ARP) Among Total Hospitalizations||Up to 148 weeks|Participants in ITT Analysis Set with total hospitalizations were analyzed.||Participants|||Count of Participants
665555|NCT01769196|Secondary|Definite Acute Exacerbations of IPF Among Adjudicated Respiratory Hospitalizations||Up to 148 weeks|Participants in the ITT Analysis Set with adjudicated respiratory hospitalizations were analyzed.||Participants|||Count of Participants
665556|NCT01769196|Secondary|Relative Change From Baseline in FVC % Predicted|"FVC was defined as the volume of air (liters) that can forcibly be blown out after taking a full breath. FVC % predicted was defined as FVC % of the participant divided by the average FVC % in the population for any person of similar age, sex, and body composition.
Adjusted means were from mixed model repeated measures (MMRM) model with baseline FVC % predicted, sLOXL2 level, concomitant pirfenidone/nintedanib use (never vs. ever), treatment, visit, and treatment-by-visit interaction terms, including all data up to Week 130
The relative change was calculated as 100% * ( value at later time point minus value at baseline ) / value at baseline, with lower values indicating a decrease and higher values indicating an increase."|Weeks 54, 106, and 130|Participants in the ITT Analysis Set with available data were analyzed. Any participant with available outcome data on baseline or post-baseline was included in the MMRM model, thus all 272 participants in each of the two treatment groups were included in this analysis.||Percent change in FVC % predicted||Standard Error|Least Squares Mean
665557|NCT01769196|Secondary|Overall Survival Among the Participants With sLOXL2 ≥ 75th Percentile||Up to 151 weeks|Participants in the ITT Analysis Set with sLOXL2 ≥ 75th percentile in peripheral blood were analyzed.||months||95% Confidence Interval|Median
665558|NCT01769196|Secondary|Overall Survival Among the Participants With sLOXL2 ≥ 50th Percentile||Up to 151 weeks|Participants in the ITT Analysis Set with sLOXL2 ≥ 50th percentile in peripheral blood were analyzed.||months||95% Confidence Interval|Median
665559|NCT01769196|Secondary|Overall Survival (OS)|Overall survival was defined as the time from randomization date to death that occurred prior to the last dose date plus 30 days.|Up to 151 weeks|ITT Analysis Set||months||95% Confidence Interval|Median
665560|NCT01769196|Primary|PFS Among the Participants With sLOXL2 ≥ 75th Percentile||Up to 148 weeks|Participants in the ITT Analysis Set with sLOXL2 ≥ 75th percentile in peripheral blood were analyzed.||months||95% Confidence Interval|Median
665561|NCT01769196|Primary|PFS Among the Participants With sLOXL2 ≥ 50th Percentile||Up to 148 weeks|Participants in the ITT Analysis Set with serum LOXL2 (sLOXL2) ≥ 50th percentile in peripheral blood were analyzed.||months||95% Confidence Interval|Median
665562|NCT01769196|Primary|Progression Free Survival|Progression free survival (PFS) was defined as the categorical decrease in forced vital capacity (FVC) % predicted (≥ 10% relative decrease in FVC and ≥ 5% absolute decrease in FVC from baseline) with confirmation at a consecutive visit at least 2 weeks later using the same criteria.|Up to 148 weeks|ITT Analysis Set||months||95% Confidence Interval|Median
665563|NCT01769105|Secondary|Change in Expressible Meibomian Glands|expressible Meibomian glands are measured with the Meibomian gland evaluator; A higher number of expressible Meibomian glands indicate a lower likelihood Meibomian Gland dysfunction.|after 3 month compared to baseline value|||number of expressible glands||Standard Deviation|Mean
665564|NCT01769105|Secondary|Change in Lipid Layer Thickness|"lipid layer thickness (LLT) is measured with the Lipiview-interferometer;
High values of LLT indicate a better lubrication of the ocular surface, so an increase in LLT can be regarded in an improvement of ocular surface.
LLT is measured in Interferometric color units (ICUs) whereas 1 ICU reflects about 1 nm lipid layer thickness."|after 3 month compared to baseline value|||nm||Standard Deviation|Mean
665565|NCT01769105|Secondary|Change in Tear Film Osmolarity|"osmolarity is measured with the tear-lab;
The osmolarity is measured in mOsm/l. A higher osmolarity can be regarded as an objective sign of dry eye disease.
A lower osmolarity after therapy can be regarded as an improvement of ocular surface disease."|after 3 month compared to baseline value|||mOsm/L||Standard Deviation|Mean
665566|NCT01769105|Secondary|Change of Break-up-time|"break-up-time is measured non-invasive with the Oculus Keratograph 5 M;
The break-up-time is measured in seconds. A low break-up-time suggests a lower lipid layer thickness. A higher break-up-time can be regarded as an improvement of ocular surface lubrication."|after 3 month compared to baseline value|||seconds||Standard Deviation|Mean
665618|NCT01768013|Primary|Pharmacokinetic: Cmax of MC1080|The mean Cmax (Maximum Observed Plasma Concentration) of MC1080 was determined|Day 1|||pg/mL||Standard Deviation|Mean
665619|NCT01768013|Primary|Pharmacokinetic: AUClast of Calcipotriol|The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for calcipotriol was determined|Day 14|||h*pg/mL||Standard Deviation|Mean
665567|NCT01769105|Primary|Change of Dry Eye Symptoms|"The symptoms of dry eyes are measured in our study with the OSDI and the SPEED questionaire. Primary outcome measure (OSDI)
Patients completed two symptom questionnaires: OSDI (Ocular Surface Disease Index) and SPEED (Standard Patient Evaluation of Eye dryness).
OSDI scores range from 0 (no symptoms) to 100 (severe symptoms). SPEED scores range from 0 (no symptoms) to 28 (severe symptoms). So a reduction of the OSDI or SPEED score indicates an improvement of subjective dry eye symptoms."|after 3 month compared to baseline value|||units on a scale||Standard Deviation|Mean
665568|NCT01768676|Secondary|Percentage of Subjects With Greater Than or Equal to 50% Reduction in Normal Sperm Morphology From Baseline to Week 26||baseline to week 26|completers population||percentage of participants|||Number
665569|NCT01768676|Secondary|Percentage of Subjects With Greater Than or Equal to 50% Reduction in Semen Volume From Baseline to Week 26||baseline to week 26|completers population||percentage of participants|||Number
665570|NCT01768676|Secondary|Percentage of Subjects With Greater Than or Equal to 50% Reduction in Sperm Motility From Baseline to Week 26|Sperm motility was based upon the WHO grading scale: grade A, B, or C.|baseline to week 26|completers population||percentage of participants|||Number
665571|NCT01768676|Secondary|Percentage of Subjects With Greater Than or Equal to 50% Reduction in Sperm Count From Baseline to Week 26||baseline to week 26|completers population||percentage of participants|||Number
665572|NCT01768676|Primary|Percentage of Subjects With a Greater Than or Equal to 50% Decrease in Sperm Concentration From Baseline to Week 26|Subjects provided 2 semen samples at each visit 2 to 12 days apart. The average value is used as the visit result.|Baseline to Week 26|Completer population is defined as those who completed the study through week 26 and had semen analysis at both baseline and week 26. This may differ from the definition of completers for the study flow.||percentage of participants|||Number
665573|NCT01768572|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs)|Adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug and does not necessary have to have a causal relationship with treatment. All adverse events that occurred from the first dose of the study drug administration up to 60 days after the end of treatment visit were considered as TEAEs. Serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or a medically important event. A summary of SAEs, all other non-serious AEs, regardless of causality, are reported in AE section.|Up to 211 days|The safety population consisted of all randomized participants who received at least 1 dose or a partial dose of study drug analyzed according to the treatment actually received.||participants|||Number
665574|NCT01768559|Secondary|Percentage of Participants Who Reached the Target of HbA1c <7%, Had no Weight Gain at Week 26, and Did Not Experience Documented (Plasma Glucose <60 mg/dL) Symptomatic Hypoglycemia During 26-Week Treatment Period|The on-treatment period for HbA1c assessment was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. The on-treatment period for body weight assessment was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug. The on-treatment period for symptomatic hypoglycemia assessment was defined as the time from the first dose of study drug up to 1 day after the last dose of study drug. Participants without post-baseline on-treatment values (HbA1c and body weight) that were no more than 30 days apart were counted as non-responders if at least one of the components (HbA1c and/or body weight) was available and showed non-response, or if they experienced at least one documented symptomatic hypoglycemia during the on-treatment period. Otherwise, they were counted as missing data.|Week 26|mITT population.Participants without post-baseline on-treatment values(HbA1c;body weight),no more than 30 days apart counted as non-responders if at least one of components(HbA1c;body weight) was available,showed non-response or experienced at least one symptomatic hypoglycemia during on-treatment period.Otherwise,they were counted as missing data.||percentage of participants|||Number
665575|NCT01768559|Secondary|Percentage of Participants Who Reached the Target of HbA1c <7% and Had no Weight Gain at Week 26|The on-treatment period for HbA1c assessment was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. The on-treatment period for body weight assessment was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug.|Week 26|mITT population. Participants without post-baseline on-treatment values (for HbA1c and body weight) that were no more than 30 days apart were counted as non-responders if at least one of the components (HbA1c and/or body weight) was available and showed non-response. Otherwise, they were counted as missing data.||percentage of participants|||Number
665576|NCT01768559|Secondary|Percentage of Participants Who Reached the Target of HbA1c <7% at Week 26 and Did Not Experienced Documented (Plasma Glucose <60 mg/dL) Symptomatic Hypoglycemia During 26 Week Treatment Period|The on-treatment period for HbA1c assessment was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. The on-treatment period for symptomatic hypoglycemia assessment was defined as the time from the first dose of study drug up to 1 day after the last dose of study drug.|Week 26|mITT population. Participants without any post-baseline on-treatment value for HbA1c were counted as non-responders if they experienced at least one symptomatic hypoglycemia. Otherwise, they were counted as missing.||percentage of participants|||Number
665577|NCT01768559|Secondary|Percentage of Participants With Documented Symptomatic and Severe Symptomatic Hypoglycemia|Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of <60 mg/dL (3.3 mmol/L). Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the participant required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.|First dose of study drug up to 3 days after the last dose administration (maximum of 185 days)|"All randomized participants who were exposed to at least one dose of study drug, regardless of the amount of treatment administered.
The 4 participants in the TID group who received Insulin Glulisine QD were analyzed according to the QD dose.The 1 participant in the QD group who received Insulin Glulisine TID was analyzed according to the TID dose"||percentage of participants|||Number
665620|NCT01768013|Primary|Pharmacokinetic: AUClast of Calcipotriol|The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for calcipotriol was determined|Day 7|||h*pg/mL||Standard Deviation|Mean
665578|NCT01768559|Secondary|Total Insulin Dose at Week 26|"The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug. Missing data was imputed using LOCF.
The outcome is reporting results of total insulin (amounts of Insulin Glargine plus Insulin Glulisine ) only for the arms in which Insulin Glulisine was administered and is not applicable for the lixisenatide arm in which only Insulin Glargine is administered. Change in dose of the insulin used by patients in the Lixisenatide arm (i.e. Insulin Glargine) is reported in the secondary Outcome Measure 9."|Week 26|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline total insulin dose assessment during on-treatment period.||U||Standard Deviation|Mean
665579|NCT01768559|Secondary|Insulin Glulisine Dose at Week 26|The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug. Missing data was imputed using LOCF.|Week 26|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline insulin glulisine dose assessment during on-treatment period.||U||Standard Deviation|Mean
665580|NCT01768559|Secondary|Change in Insulin Glargine Dose From Baseline to Week 26|Change in Insulin glargine dose was calculated by subtracting the baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug.|Baseline, Week 26|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline insulin glargine dose assessment during on-treatment period.||U||Standard Error|Least Squares Mean
665581|NCT01768559|Secondary|Change in Glucose Excursions From Baseline to Week 26 (in Participants Who Had an Injection of IMP Before Breakfast)|Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the standardized meal test, before study drug administration. Change in glucose excursions was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug.|Baseline, Week 26|mITT population. Here, number of participants analyzed = participants with IMP injection before breakfast and baseline and at least one post-baseline glucose excursion assessment during on-treatment period.||mmol/L||Standard Deviation|Mean
665582|NCT01768559|Secondary|Change in PPG From Baseline to Week 26 (in Participants Who Had an Injection of Investigational Medicinal Product [IMP] Before Breakfast)|The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. Change in PPG was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug.|Baseline, Week 26|mITT population. Here, number of participants analyzed = participants with IMP injection before breakfast and baseline and at least one post-baseline 2-hour PPG assessment during on-treatment period.||mmol/L||Standard Deviation|Mean
665583|NCT01768559|Secondary|Change in FPG From Baseline to Week 26|Change in FPG was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to 1 day after the last dose of study drug.|Baseline, Week 26|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline FPG assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
665584|NCT01768559|Secondary|Change in Average 7-point SMPG Profiles From Baseline to Week 26|Participants recorded a 7-point plasma glucose profile measured before and 2 hours after each meal and at bedtime three times in a week before baseline, before visit Week 12 and before visit week 26 and the average value across the profiles performed in the week a visit for the 7-time points was calculated. Change in average 7-point SMPG was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to the day of last dose of study drug.|Baseline, Week 26|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline 7-point SMPG assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
665585|NCT01768559|Secondary|Percentage of Participants With no Weight Gain at Week 26|The on-treatment period for this efficacy variable was the time from the first dose of study drug up to 3 days after the last dose of study drug.|Week 26|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline body weight assessment during on-treatment period.||percentage of participants|||Number
665586|NCT01768559|Secondary|Percentage of Participants With HbA1c Level <7% and ≤6.5% at Week 26|The on-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. Missing data was imputed using LOCF.|Week 26|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline HbA1c assessment during on-treatment period.||percentage of participants|||Number
665587|NCT01768559|Primary|Change in Body Weight From Baseline to Week 26|"Primary outcome was the comparison between Lixisenatide versus Insulin Glulisine TID.
Change in body weight was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug."|Baseline, Week 26|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline body weight assessment during on-treatment period.||kg||Standard Error|Least Squares Mean
665588|NCT01768559|Primary|Change in HbA1c From Baseline to Week 26|Change in HbA1C was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using last on-treatment observation carried forward (LOCF). On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. Here, number of participants analyzed = participants with baseline and at least one post-baseline HbA1c assessment during on-treatment period.|Baseline, Week 26|modified intent-to-treat (mITT) population: all randomized participants who received at least one dose of study drug; and had both baseline and at least one post-baseline efficacy assessment, irrespective of compliance with study protocol/procedures.||percentage of hemoglobin||Standard Error|Least Squares Mean
665589|NCT01768325|Secondary|Number of Needle Passes||36 months|||Needle passes||Standard Deviation|Mean
665590|NCT01768325|Primary|Diagnostic Accuracy.||36 months|One patient was lost to follow up. Final diagnosis was unconfirmed.||Percentage of participants|||Number
665592|NCT01768286|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as on-treatment virologic failure or virologic relapse.
On-Treatment Virologic Failure was defined as
Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)
Virologic relapse was defined as confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Baseline to posttreatment Week 24|Full Analysis Set||percentage of participants|||Number
665593|NCT01768286|Secondary|Change From Baseline in HCV RNA at Week 8||Baseline; Week 8|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
665594|NCT01768286|Secondary|Change From Baseline in HCV RNA at Week 4||Baseline; Week 4|Full Analysis Set||log10 IU/mL||Standard Deviation|Mean
665595|NCT01768286|Secondary|Change From Baseline in HCV RNA at Week 2||Baseline; Week 2|Full Analysis Set||log10 IU/mL||Standard Deviation|Mean
665596|NCT01768286|Secondary|Change From Baseline in HCV RNA at Week 1||Baseline; Week 1|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
665597|NCT01768286|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 24||Week 24|Participants in the Full Analysis Set with available data were analyzed. Participants in the LDV/SOF 12 Weeks and LDV/SOF+RBV 12 Weeks groups did not continue treatment past Week 12 and are not included in the analysis.||percentage of participants|||Number
665598|NCT01768286|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 12||Week 12|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants|||Number
665599|NCT01768286|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 8||Week 8|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants|||Number
665600|NCT01768286|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 4||Week 4|Full Analysis Set||percentage of participants|||Number
665601|NCT01768286|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 2||Week 2|Full Analysis Set||percentage of participants|||Number
665602|NCT01768286|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 1||Week 1|Full Analysis Set||percentage of participants|||Number
665603|NCT01768286|Secondary|Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set||percentage of participants|||Number
665604|NCT01768286|Primary|Incidence of Adverse Events Leading to Permanent Discontinuation From Any Study Drug|The percentage of participants who experienced an adverse event leading to permanent discontinuation from any study drug was summarized.|Up to 24 weeks|Safety Analysis Set||percentage of participants|||Number
665605|NCT01768286|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) 12 weeks following the last dose of study drug.|Posttreatment Week 12|Full Analysis Set: participants who were randomized and received at least one dose of study drug.||percentage of participants|||Number
665606|NCT01768117|Secondary|Number of Participants With 4-fold Increase in Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level||1 month after vaccination 3|||participants|||Number
665607|NCT01768117|Secondary|Number of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level >= LLOQ For All 4 Primary Test Strains Combined||1 month after vaccination 3|||participants|||Number
665608|NCT01768117|Secondary|Number of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level >= LLOQ||1 month after vaccination (Vac) 1, 2, Immediately prior to vaccination 3|||participants|||Number
665609|NCT01768117|Primary|Percentage of Participants With at Least One Adverse Event (AE)||Vaccination 1 up to 1 month after Vaccination 3|||percentage of participants|||Number
665610|NCT01768117|Primary|Number of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)||1 month after vaccination 3|||participants|||Number
665611|NCT01768013|Secondary|Efficacy: Subjects With 'Clear' or 'Almost Clear' Disease by Investigator's Global Assessment at Day 28.|"Subjects with 'clear' or 'almost clear' disease by investigator's globala ssessment at day 28.
Investigator global assessment (IGA) is based on the investigator’s assessment of the disease severity (Plaque thickening, Scaling and Erythema) using a 6-point scale (Clear,Almost clear, Mild,Moderate, Severe, and Very severe). The assessment represents the average lesion severity on the trunk and limbs. IGA can range between 1 (best) and 6 (worst). The assessment is based on the condition of the disease at the time of evaluation, and not in relation to the condition at a previous visit."|Day 28|||participants|||Number
665612|NCT01768013|Secondary|Efficacy: Percentage Change in m-PASI From Baseline to Day 28|"Psoriasis Area and Severity Index (PASI) is based on the investigator's assessment of the disease.
The extent and severity of redness, thickness and scaliness of psoriasis are recorded for three regions (arms, trunk and legs) and these are used to calculate PASI. The PASI can range between 0 (best) to 64.8 (worst). m-PASI indicate that the scale is modified."|Baseline to Day 28|||percentage of change||Standard Deviation|Mean
665613|NCT01768013|Primary|Pharmacokinetic: AUClast of MC1080.|The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for MC 1080 was determined|Day 14|||h*pg/mL||Standard Deviation|Mean
665614|NCT01768013|Primary|Pharmacokinetic: AUClast of MC1080.|To assess the The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for MC 1080 was determined|Day 7|||h*pg/mL||Standard Deviation|Mean
665615|NCT01768013|Primary|Pharmacokinetic: AUClast of MC1080|The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for MC 1080 was determined|Day 1|||h*pg/mL||Standard Deviation|Mean
665616|NCT01768013|Primary|Pharmacokinetic: Cmax of MC1080|The mean Cmax (Maximum Observed Plasma Concentration) of MC1080 was determined|Day 14|||pg/mL||Standard Deviation|Mean
665617|NCT01768013|Primary|Pharmacokinetic: Cmax of MC1080|The mean Cmax (Maximum Observed Plasma Concentration) of MC1080 was determined|Day 7|||pg/mL||Standard Deviation|Mean
665625|NCT01768013|Primary|Pharmacokinetic: AUClast of Betamethasone 17-propionate|The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone 17-propionate was determined|Day 14|||h*pg/mL||Standard Deviation|Mean
665626|NCT01768013|Primary|Pharmacokinetic: AUClast of Betamethasone 17-propionate|The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone 17-propionate was determined|Day 7|||h*pg/mL||Standard Deviation|Mean
665627|NCT01768013|Primary|Pharmacokinetic: AUClast of Betamethasone 17-propionate|The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone 17-propionate was determined|Day 1|||h*pg/mL||Standard Deviation|Mean
665628|NCT01768013|Primary|Pharmacokinetic: Cmax of Betamethasone 17-propionate|The mean Cmax (Maximum Observed Plasma Concentration) of betamethasone 17- propionate was determined|Day 14|||pg/mL||Standard Deviation|Mean
665629|NCT01768013|Primary|Pharmacokinetic: Cmax of Betamethasone 17-propionate|The mean Cmax (Maximum Observed Plasma Concentration) of betamethasone 17- propionate was determined|Day 7|||pg/mL||Standard Deviation|Mean
665630|NCT01768013|Primary|Pharmacokinetic: Cmax of Betamethasone 17-propionate|The mean Cmax(Maximum Observed Plasma Concentration) of betamethasone 17- propionate was determined|Day 1|||pg/mL||Standard Deviation|Mean
665631|NCT01768013|Primary|Pharmacokinetic: AUClast of Betamethasone Dipropionate|The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone dipropionate was determined|Day 14|||h*pg/mL||Standard Deviation|Mean
665632|NCT01768013|Primary|Pharmacokinetic: AUClast of Betamethasone Dipropionate|The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone dipropionate was determined|Day 7|||h*pg/mL||Standard Deviation|Mean
665633|NCT01768013|Primary|Pharmacokinetic: AUClast of Betamethasone Dipropionate|The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone dipropionate was determined|Day 1|||h*pg/mL||Standard Deviation|Mean
665634|NCT01768013|Primary|Pharmacokinetic: Cmax of Betamethasone Dipropionate|The mean Cmax (Maximum Observed Plasma Concentration) of betamethasone dipropionate was determined|Day 14|||pg/mL||Standard Deviation|Mean
665635|NCT01768013|Primary|Pharmacokinetic: Cmax of Betamethasone Dipropionate|The mean Cmax (Maximum Observed Plasma Concentration) of betamethasone dipropionate was determined|Day 7|||pg/mL||Standard Deviation|Mean
665636|NCT01768013|Primary|Pharmacokinetic: Cmax of Betamethasone Dipropionate|The mean Cmax(Maximum Observed Plasma Concentration) of betamethasone dipropionate was determined.|Day 1|||pg/mL||Standard Deviation|Mean
665637|NCT01768000|Secondary|Involvement Evaluation Questionnaire (IES)|The 31-item Involvement Evaluation Questionnaire (IEQ; Van Wijngaarden et al., 2000) measures caregiver burden. It has been validated for caregivers of individuals with schizophrenia, covers a broad domain of caregiving consequences and refers to burden experienced within the past 4 weeks. Mean scores are calculated for the total scale and sub-scales. Total scores can range from 29 to 145 with sub-scale domains ranging - tension, 9-45; supervision, 6-30; worrying, 6-30; and urging, 8-40. Lower total and subscale scores indicate less burden and higher scores greater level of caregiver burden.|4 months following baseline assessment|||units on a scale||Standard Deviation|Mean
665638|NCT01768000|Secondary|Satisfaction With Life Scale|8 out of 18 items from the Satisfaction With Life Scale (Test et al., 2005) will measure the perceived quality of life of the individual with schizophrenia by tapping into global satisfaction in domains relevant to CAT (e.g., How satisfied are you with yourself on the whole? - 5 point scale, not at all - great deal). This scale is well-validated with a schizophrenia population and is being shortened as not all items are relevant to CAT nor expected to be sensitive to change in a 4 month period, and there is a need to abbreviate the battery to reduce the risk of fatigue in a lengthy phone interview. These 8 items comprise four domains of social relationships, employment/work, social and present life and living situation. A low score indicates less satisfaction in these domains and a higher score indicating greater satisfaction. Total scores can range from 8-40 and subscale scores range from 1-5.|4 months following baseline assessment|||units on a scale||Standard Deviation|Mean
665639|NCT01768000|Secondary|Brief Adherence Rating Scale (BARS)|The Brief Adherence Rating Scale (BARS; Byerly et al., 2008) is a 4-item, valid, reliable, sensitive, measure with which to obtain specific estimates of antipsychotic medication adherence of outpatients with schizophrenia. A total percentage score on a scale ranging from 0 to 100, with 0 indicating less adherence and 100 total adherence.|4 months following baseline assessment|||units on a scale||Standard Deviation|Mean
665640|NCT01768000|Primary|Multnomah Community Ability Scale (MCAS)|The Multnomah Community Ability Scale (MCAS; Barker et al., 1994) is a 17-item scale assessing functionality in four domains - health, adaptation, social skills and behaviour. Ratings are made on the basis of an interview with the patient and their family member. The MCAS generates a total score ranging from 17 to 85. Items on the MCAS are scored on a five-point scale. The four total domain scores ranges are - health, 5-25; adaptation, 3-15; social skills, 5-25; behaviour, 4-20. Lower ratings indicate less ability. Higher ratings usually mean an assessment of greater ability.|4 months following baseline assessment|||units on a scale||Standard Deviation|Mean
665641|NCT01767987|Secondary|Successful PCI|For the purposes of this study, a successful PCI is considered one where no additional coronary interventions were required within 24 hours after the initial PCI.|At discharge or within 1 days, whichever comes first|The only subject undergoing PCI intervention was from the Placebo Group and was thus the only subject for whom these protocol required data points were collected.||participants|||Number
665642|NCT01767987|Secondary|Death, MI, Revascularization, CHF||1-4 weeks post PCI|||participants|||Number
665643|NCT01767987|Secondary|Death, Myocardial Infarction (Biomarker Greater Than 2x Normal), CHF, Cardiac Arrest||At discharge or within 1 days, whichever comes first|The only subject undergoing PCI intervention was from the Placebo Group and was thus the only subject for whom these protocol required data points were collected.||participants|||Number
665644|NCT01767987|Secondary|Left Ventricular End Diastolic Pressure (LVEDP)||During the PCI (Percutaneous Coronary Intervention) procedure - starting at timepoint of guidewire insertion into the access artery until removal of guidewire|The only subject undergoing PCI intervention was from the Placebo Group and was thus the only subject for whom this protocol required data point was collected.||mmHG|||Number
665645|NCT01767987|Secondary|Incidence of Non-sustained Ventricular Tachycardia or Atrial Fibrillation Post PCI||Following completion of PCI through hospital discharge|The only subject undergoing PCI intervention was from the Placebo Group and was thus the only subject for whom these protocol required data points were collected.||participants|||Number
665646|NCT01767987|Secondary|Incidence of Atrial Fibrillation, Ventricular Tachycardia, or Ventricular Fibrillation in Coronary Cath Lab|Abnormal heart activity|During the PCI (Percutaneous Coronary Intervention) procedure - starting at timepoint of guidewire insertion into the access artery until removal of guidewire|The only subject undergoing PCI intervention was from the Placebo Group and was thus the only subject for whom these protocol required data points were collected.||participants|||Number
665647|NCT01767987|Secondary|TIMI Flow Rate (Grade)|"This TIMI classification was developed by the TIMI (Thrombolysis In Myocardial Infarction) study group to semiquantitatively assess coronary artery perfusion beyond point of occlusion on coronary angiography.* TIMI Grade [Description] TIMI 0 - no perfusion [no antegrade flow beyond the point of occlusion] TIMI 1 - penetration without perfusion [faint antegrade coronary flow beyond the occlusion with incomplete filling of the distal coronary bed] TIMI 2 - partial perfusion [delayed or sluggish antegrade flow with complete filling of the distal territory] TIMI 3 - complete perfusion [normal flow with complete filling of the distal territory]
*(see http://radclass.mudr.org/content/timi-grade-flow-grading-coronary-blood-flow-during-coronary-angiography) TIMI 0 is the least favorable grade. TIMI 3 is the most favorable grade."|TIMI Flow Rate (Grade) is assessed immediately after an interventional reperfusion attempt during a PCI (Percutaneous Coronary Intervention) procedure.|The only subject undergoing PCI intervention was from the Placebo Group and was thus the only subject for whom this protocol required data point was collected.||units on a scale|||Number
665648|NCT01767987|Primary|CK-MB|CK-MB labs will be drawn 8-10 hrs after PCI or at discharge whichever comes first|8-10 hrs post PCI|For the single subject completing the PCI intervention, CK-MB was not done because the CK level was below the threshold running the CK-MB test.|||||
665649|NCT01767987|Primary|Troponin|Troponin labs will be drawn 8-10 hrs after PCI or at discharge whichever comes first|8-10 hrs post PCI|Of the 4 Ranolazine Group subjects, 1 was withdrawn for pre-procedure study drug non-compliance; 3 had no PCI intervention. Of the 2 Placebo Group subject, 1 had no PCI intervention. The only subject undergoing PCI intervention was from the Placebo Group and was thus the only subject undergoing this protocol required test.||NG/ML|||Number
665650|NCT01767701|Other Pre-specified|Effect of Raltegravir Therapy on Specific Inflammatory Marker of MS Activity.|Measured by Human C-Reactive Protein (HCRP) which is a measure of general inflammation. The higher the value the more inflammatory response is present. The HCRP was measured monthly for six months. The mean value for the baseline three months was compared with the mean value taken for the second (treatment) three months.|Baseline to 6 months|ITT||ng/mL||Full Range|Mean
665651|NCT01767701|Other Pre-specified|Mean Number of Adverse Events Per Patient|"This outcome will be assessed by blood and urine sampling; collection of patient reported symptoms and neurological and physical exams.
This measure is the total number of adverse events recorded for each type of event during the study period. The number of participants is 31 which is the number screened and enrolled in the study. Eleven participants did not meet the criterion for baseline i.e. having a gadolinium enhancing lesion on MRI at the baseline visit and therefore did not continue to the baseline observation period. The adverse events for the 11 participants who did not begin the study observation period were recorded during the screening period and added to the 20 participants who were studied during the 6 months of the study. Adverse events are recorded as total number during the study period. Each patient may have had more than one adverse event."|Screening to six months|ITT||Adverse events||Full Range|Mean
665652|NCT01767701|Secondary|Percent of Subjects With Scans Free From Enhancing Lesions in Raltegravir Treated Subjects vs. Baseline|This measure is the cumulative percentage of subjects who had scans free from Gd enhancing lesions during the first three months (baseline) compared with the second three months (treatment). These percentages are expressed as a total percentage for the baseline and for the treatment periods.|Baseline to 6 months|ITT||percentage of subjects|||Number
665653|NCT01767701|Secondary|Cumulative Number of Gd-T1 Enhancing Lesions|This measure is the number of gadolinium-enhancing T1 lesions as determined by MRI taken on the monthly basis during the six months of the study.|At Baseline and monthly for 6 months|ITT||Gadolinium enhancing T1 lesions||Full Range|Mean
665654|NCT01767701|Secondary|Changes in Kurtzke Extended Disability Status Scale (EDSS) Score|"The Kurtzke Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis. The scale has been developed by John F. Kurtzke. The EDSS quantifies disability in eight Functional Systems (FS) and allows neurologists to assign a Functional System Score (FSS) in each of these. 0 = Normal 1-1.5 = No disability, but some abnormal neurological signs 2-2.5 = Minimal disability 3-4.5 = Moderate disability, affecting daily activities, but you can still walk. A lower score indicates less disability.
5-8 = More severe disability, impairing your daily activities and requiring assistance with walking 8.5-9.5 = Very severe disability, restricting you to bed 10 = Death EDSS scores were measured monthly over 6 months and the mean of the measurements for the first three months (baseline) was recorded to use calculate the change from baseline compared with the mean of measurements taken monthly during the second three months (treatment)."|Baseline and monthly to month 6|All patients enrolled in clinical trial||units on a scale||Standard Deviation|Mean
665655|NCT01767701|Secondary|Change in Score on Multiple Sclerosis Functional Composite (MSFC). This a Composite Score Based on the Measurement of Time in Seconds for the Three Separate Measurements.|Explore preliminary clinical responses in relapsing-remitting multiple sclerosis subjects treated with Raltegravir, compared with baseline as measured by Patient Reported Outcomes (Questionnaires). The MSFC is a composite score consisting of the standardly derived composite score from 9-hole peg test (9HPT), timed walk and PASAT scores. 9HPT is measured as timed speed to complete the task; higher scores indicate less disability. The 25-foot walk is measured as timed speed; higher scores indicate less disability. The Paced Auditory Serial Addition Test (PASAT) The PASAT is a measure of cognitive function that assesses auditory information processing speed and flexibility, as well as calculation ability. It is a timed speed test measured in seconds. In the PASAT a lower score indicates less disability.|Baseline and monthly until month 6.|ITT||seconds||Standard Deviation|Mean
665821|NCT01766024|Secondary|Т½ of Interferon Beta-1a Blood Samples Were Taken Before the Injection, Then After 15 Min, 30 Min, 45 Min, 1 Hour, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours and 48 Hours.|Secondary outcome measure for pharmacokinetics analysis|0 to 48 hours post-dose||||||
665656|NCT01767701|Secondary|The Cumulative Number of New or Enlarging T2 Weighted Lesions on Brain MRI.|"Demonstrate a reduction in the cumulative number of new or enlarging T2 weighted lesions on brain MRI over the period of treatment with Raltegravir compared with baseline.
Within-patient changes in lesion count calculated after-before."|Baseline and monthly for 6 months|ITT||T2-weighted lesions||Full Range|Mean
665657|NCT01767701|Primary|The Number of New or Recurrent Gd-enhancing Lesions That Appear on Brain T1-weighted MRI|"Demonstrate in subjects with relapsing remitting multiple sclerosis a reduction in the number of new or recurrent Gd-enhancing lesions that appear on brain T1-weighted MRI over the period of treatment with raltegravir, compared to baseline.
Within patient change in number of lesions was calculated by subtracting the after treatment period (3 months) minus before treatment period (3 months)."|Baseline and at 6 months|ITT||lesions||Full Range|Mean
665658|NCT01767688|Secondary|Number of Participants Discontinued From Study Due to AEs|An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation patient/subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 14 days post-dose|All participants that received omarigliptin 25 mg.||Participants|||Number
665659|NCT01767688|Secondary|Number of Participants Experiencing Adverse Events (AEs)|An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation patient/subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 14 days post-dose|All participants that received omarigliptin 25 mg.||Participants|||Number
665660|NCT01767688|Secondary|Apparent Terminal Phase Half-life (t½)||Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96, and 168 hours post-dose|All participants that received omarigliptin 25 mg.||hr||Geometric Coefficient of Variation|Geometric Mean
665661|NCT01767688|Secondary|Time to Maximum Observed Plasma Drug Concentration (Tmax)||Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96, and 168 hours post-dose|All participants that received omarigliptin 25 mg.||hr||Full Range|Median
665662|NCT01767688|Secondary|Maximum Observed Plasma Concentration (Cmax)||Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96, and 168 hours post-dose|All participants that received omarigliptin 25 mg.||nM||95% Confidence Interval|Geometric Mean
665663|NCT01767688|Secondary|Plasma Concentration at 168 Hours After Dosing (C168h)||168 hours post-dose|All participants that received omarigliptin 25 mg.||nM||95% Confidence Interval|Geometric Mean
665664|NCT01767688|Secondary|Area Under the Concentration Versus Time Curve From Hour 0 to 168 Hours After Dosing (AUC0-168h)||Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96, and 168 hours post-dose|All participants that received omarigliptin 25 mg.||µM*hr||95% Confidence Interval|Geometric Mean
665665|NCT01767688|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) From Hour 0 to Infinity (AUC0-∞)||Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96, and 168 hours post-dose|All participants that received omarigliptin 25 mg.||µM*hr||95% Confidence Interval|Geometric Mean
665666|NCT01767597|Primary|Percentage of Patients Appropriately Seeking Care|"Subjects who are considered required to seek further care are as follows:
those who need HBV vaccination (non-immunized)
those who are infected with hepatitis B virus (infected)
Of these patients, subjects who have achieved appropriate care are considered as follows:
non immunized subjects who have initiated HBV vaccination sequence (vaccinated)
infected subjects who seek health care at a specialized center, allowing to quantify the severity of liver-related disease (infected with care)
The percentage of patients appropriately seeking care will be then calculated by the following formula:
((nb Vaccinated + nb infected with care) / (nb non-immunized + nb infected))*100"|6 months|Only participants needing further medical intervention were included in analysis: non-immunized (HBsAg negative, anti-HBc antibody negative, anti-HBs antibody negative) or infected (HBsAg positive).||percentage of participants|||Number
665667|NCT01767519|Secondary|Change From Study Baseline in the Social Limitations Domain on the King's Health Questionnaire in Treatment Cycle 1|The King's Health Questionnaire is a disease-specific questionnaire that measures the quality of life of patients with urinary incontinence. The questionnaire consists of 7 domains, including the social limitations domain. Domain scores range from 0 to 100, with a lower score indicating a preferable health status. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.|Study Baseline, Week 12|Intent-to-Treat: includes all patients according to the group to which they are randomized||Scores on a Scale||Standard Deviation|Mean
665668|NCT01767519|Secondary|Change From Study Baseline in the Role Limitations Domain on the King's Health Questionnaire in Treatment Cycle 1|The King's Health Questionnaire is a disease-specific questionnaire that measures the quality of life of patients with urinary incontinence. The questionnaire consists of 7 domains, including the role limitations domain. Domain scores range from 0 to 100, with a lower score indicating a preferable health status. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.|Study Baseline, Week 12|Intent-to-Treat: includes all patients according to the group to which they are randomized||Scores on a Scale||Standard Deviation|Mean
665669|NCT01767519|Secondary|Change From Study Baseline in the Number of Nocturia Episodes in Treatment Cycle 1|Nocturia episodes are measured over a 3 day diary prior to each visit in Treatment Cycle 1. A nocturia episode is a void (urinating into the toilet) that interrupts one's sleep. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.|Study Baseline, Week 12|Intent-to-Treat: includes all patients according to the group to which they are randomized||Nocturia Episodes||Standard Deviation|Mean
665670|NCT01767519|Secondary|Change From Study Baseline in the Number of Micturition Episodes in Treatment Cycle 1|The number of micturition episodes (the number of times a patient urinates into the toilet) in Treatment Cycle 1 was recorded by the patient in a bladder diary during 3 consecutive days in the week prior to the visit. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.|Study Baseline, Week 12|Intent-to-Treat: includes all patients according to the group to which they are randomized||Micturition Episodes||Standard Deviation|Mean
665671|NCT01767519|Secondary|Percentage of Patients With a Positive Response on the Single-Item Treatment Benefit Scale During Treatment Cycle 1|A positive treatment response on the Treatment Benefit Scale is a score of either 1 or 2, representing ‘greatly improved’ or ‘improved.’|Week 12|Intent-to-Treat: includes all patients according to the group to which they are randomized||Percentage of Patients||95% Confidence Interval|Number
665672|NCT01767519|Primary|Percentage of Patients With 100% Reduction in Incontinence Episodes in Treatment Cycle 1|Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of incontinence episodes are averaged daily during this period and compared to baseline to determine 100% reduction in episodes.|Study Baseline, Week 12|Intent-to-Treat: includes all patients according to the group to which they are randomized||Percentage of Patients|||Number
665673|NCT01767519|Primary|Change From Study Baseline in Number of Episodes of Urinary Incontinence in Treatment Cycle 1|Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of incontinence episodes are averaged daily during this period. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.|Study Baseline, Week 12|Intent-to-Treat: includes all patients according to the group to which they are randomized||Incontinence Episodes||Standard Deviation|Mean
665677|NCT01767467|Secondary|Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology|From first vaccination up to 6 months post last vaccination|||Subjects|||Number
665678|NCT01767467|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From first vaccination up to 6 months post last vaccination|||Subjects|||Number
665679|NCT01767467|Secondary|Anti-gE Humoral Immunogenicity in Subjects With Confirmed HZ and Matched Controls||At Month 0 and at Month 2||01/2018||||
665680|NCT01767467|Secondary|Vaccine Response Rates (VRR) for gE-specific CD4 [2+] T-cells, Expressing at Least 2 Activation Markers.|"Among markers expressed were IFN-γ, IL-2, TNF-α and CD40L, as determined by in vitro ICS. Vaccine response defined as:
For initially subjects with pre-vaccination T cell frequencies below the threshold, at least a 2-fold increase as compared to the threshold (2x<320> Events/106 CD4+ T cells) For initially subjects with pre-vaccination T cell frequencies above the threshold, at least a 2-fold increase as compared to pre-vaccination T cell frequencies"|At Month 1, Month 2 and Month 13|The analysis was performed on the ATP cohort for Cell Mediated Immunity (CMI), which included all evaluable subjects included in the ATP cohort for immunogenicity analyses and with blood samples analysed to assess CMI response.||Subjects|||Number
665681|NCT01767467|Secondary|Frequency of gE -Specific Cluster of Differentiation 4+ T Cells (CD4+) Expressing at Least 2 Activation Markers|Among markers expressed were interferon-gamma (IFN-γ), interleukin-2 (IL-2), tumour necrosis factor-alpha (TNF-α) and cluster of differentiation 40 ligand (CD40L), as determined by in vitro intracellular cytokine staining (ICS). Note: results for Month 13 were not yeat available at the time of this posting.We will update them once they become available.|At Month 0, Month 1, Month 2 and Month 13|||CD4+ cells/million T-cells||Standard Deviation|Mean
665682|NCT01767467|Secondary|Vaccine Response Rates (VRR) for Anti-gE Antibody ELISA Concentrations|The vaccine response rate (VRR) was defined as the percentage of subjects who have at least a 4-fold increase in the anti-gE Ab concentration as compared to the pre-vaccination anti-gE Ab concentration, for subjects who are seropositive at baseline or, at least a 4-fold increase in the anti-gE Ab concentration as compared to the anti-gE Ab cut-off value for seropositivity, for subjects who are seronegative at baseline. Vaccine response was measured in all subjects.|At Month 1, Month 2 and Month 13|The analysis was performed on the According-to-Protocol (ATP) cohort for Humoral immunogenicity included all subjects who met all eligibility criteria, who received the full vaccination course, complied with the protocol and for whom data concerning immunogenicity outcome measures were available up to the Month 2 visit.||Subjects|||Number
665683|NCT01767467|Secondary|Concentrations of Anti-gE Antibodies|"Antibody concentrations given in enzyme linked immunosorbent assay (ELISA) units per millilitre (EU/mL) were expressed as Geometric Mean Concentrations (GMCs) in all subjects.
Note: results for Month 13 were not yeat available at the time of this posting.We will update them once they become available."|At Month 0, Month 1, Month 2 and Month 13|The analysis was performed on the According-to-Protocol (ATP) cohort for Humoral immunogenicity included all subjects who met all eligibility criteria, who received the full vaccination course, complied with the protocol and for whom data concerning immunogenicity outcome measures were available up to the Month 2 visit.||EU/mL||95% Confidence Interval|Geometric Mean
665684|NCT01767467|Secondary|Anti-gE Antibody Concentration|Concentrations were presente as geometeric mean concentrations (GMCs) and expressed as milli-international units per milliliter (mIU/mL).This parameter was assessed in all vaccinated subjects excluding subjects with Non-Hodgkin B-cell Lymphoma.|At Month 2|The analysis was performed on the According-to-Protocol (ATP) cohort for Humoral immunogenicity included all subjects who met all eligibility criteria, who received the full vaccination course, complied with the protocol and for whom data concerning immunogenicity outcome measures were available up to the Month 2 visit.||mIU/mL||95% Confidence Interval|Geometric Mean
665822|NCT01766024|Secondary|Тmax of Interferon Beta-1a Blood Samples Were Taken Before the Injection, Then After 15 Min, 30 Min, 45 Min, 1 Hour, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours and 48 Hours.|Secondary outcome measure for pharmacokinetics analysis|0 to 48 hours post-dose||||||
665685|NCT01767467|Secondary|Number of Subjects With Antibody Titer Equal to or Above Cut-off|This parameter was assessed in all vaccinated subjects excluding subjects with Non-Hodgkin B-cell Lymphoma. The cut-off value is 97 mIU/mL.|At Month 2|The analysis was performed on the According-to-Protocol (ATP) cohort for Humoral immunogenicity included all subjects who met all eligibility criteria, who received the full vaccination course, complied with the protocol and for whom data concerning immunogenicity outcome measures were available up to the Month 2 visit.||Subjects|||Number
665686|NCT01767467|Secondary|Occurrence of Confirmed HZ Cases||From Month 0 until study end||01/2018||||
665687|NCT01767467|Primary|Number of Days With Solicited General Symptoms||within the 7 days (Day 0-6) after each vaccination||01/2018||||
665688|NCT01767467|Primary|Number of Days With Solicited Local Symptoms||within 7 days (Days 0-6) after each vaccination||01/2018||||
665689|NCT01767467|Primary|Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|Up to 30 days post last vaccination|||Subjects|||Number
665690|NCT01767467|Primary|Number of Subjects With Serious Adverse Events (SAEs).|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From first vaccination up to 30 days post last vaccination|||Subjects|||Number
665691|NCT01767467|Primary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|Up to 30 days (Days 0-29) after each vaccination|||Subjects|||Number
665692|NCT01767467|Primary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.|Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], headache, myalgia, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|during the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, on sujcts with their symptom sheets completed.||Subjects|||Number
665693|NCT01767467|Primary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms.|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Since the study is ongoing, results for the individual groups are blinded. Hence results were presented per the total number of subjects.|Up to 7 days (Days 0-6) after each vaccination|The analysis was performed on the Total Vaccinated cohort, on sujcts with their symptom sheets completed.||Subjects|||Number
665694|NCT01767467|Primary|Adjusted Geometric Mean Concentration of Anti-gE Antibodies|The Adjusted geometric mean concentration was measured in all subjects excluding those with Non-Hodgkin B-cell Lymphoma and Chronic Lymphocytic Leukaemia.|At Month 2|The analysis was performed on the According-to-Protocol (ATP) cohort for Humoral immunogenicity included all subjects who met all eligibility criteria, who received the full vaccination course, complied with the protocol and for whom data concerning immunogenicity outcome measures were available up to the Month 2 visit.||mIU/mL||95% Confidence Interval|Geometric Mean
665695|NCT01767467|Primary|Vaccine Response Rates (VRR) for Anti-gE Antibody ELISA Concentrations|"Vaccine response rate was the number of subjects with a vaccine response. Vaccine response was defined as:
For initially seronegative subjects, antibody concentration at Month 2 ≥ 4 fold the cut-off for Anti-gE (4x97 mIU/mL) For initially seropositive subjects, antibody concentration at Month 2 ≥ 4 fold the pre-vaccination antibody concentration This analysis was performed in subjects with haematologic malignancies excluding subjects with Non-Hodgkin B-cell Lymphoma and Chronic Lymphocytic Leukaemia."|At Month 2|The analysis was performed on the According-to-Protocol (ATP) cohort for Humoral immunogenicity included all subjects who met all eligibility criteria, who received the full vaccination course, complied with the protocol and and for whom data concerning immunogenicity outcome measures were available up to the Month 2 visit.||Percentage||95% Confidence Interval|Number
665696|NCT01767376|Secondary|Number of Subjects With Serious Adverse Events SAE(s)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Throughout the study (Month 0 up to Month 2)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.||Participants|||Count of Participants
665697|NCT01767376|Secondary|Number of Subjects With Unsolicited Adverse Events AE(s)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 31-day (Days 0-30) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.||Participants|||Count of Participants
665698|NCT01767376|Secondary|Number of Subjects With New Onset of Chronic Diseases (NOCDs)|NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.|Throughout the study (Month 0 up to Month 2)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.||Participants|||Count of Participants
665823|NCT01766024|Primary|AUC(0-168) and AUC(0-∞) of Neopterin and MxA Protein|Primary outcome measure for pharmacodynamics analysis. Blood samples were taken before the injection, then after 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hours.|0 to 168 hours post-dose|||(ng/ml)*h||Inter-Quartile Range|Median
665699|NCT01767376|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache and fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination. Results are presented across doses.|During the 4-day (Days 0-3) period following each vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.||Participants|||Count of Participants
665700|NCT01767376|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. Results are presented across doses, after each vaccination (with Nimenrix, Boostrix, total).|During the 4-day (Days 0-3) following each vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.||Participants|||Count of Participants
665701|NCT01767376|Secondary|Booster Responses for Anti-PT, Anti-FHA and Anti-PRN Concentrations|"Booster response to the pertussis components is defined as:
For initially seronegative subjects, antibody concentration ≥ 4*cut_off (IU/mL) at one month post-vaccination;
For initially seropositive subjects with pre-vaccination antibody concentration < 4*cut_off (IU/mL) : antibody concentration at one month post-vaccination ≥ 4 fold the pre-vaccination antibody concentration;
For initially seropositive subjects with pre-vaccination antibody concentration ≥ 4*cut_off (IU/mL) : antibody concentration at one month post-vaccination ≥ 2 fold the pre-vaccination antibody concentration."|One month after Boostrix vaccination (i.e. Month 1 for Nimenrix + Boostrix Group and Boostrix Group and Month 2 for Nimenrix Group)|The analysis was performed on the ATP cohort for immunogenicity will included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccine dose.||Participants|||Count of Participants
665702|NCT01767376|Secondary|Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Above the Cut-off Value|The reference cut-off value of the assay was an antibody concentration ≥ 5.0 ELISA units per milliliter (EL.U/mL)|Prior to (i.e. Month 0 for Nimenrix + Boostrix Group and Boostrix Group and Month 1 for Nimenrix Group) and one month after Boostrix vaccination (i.e. Month 1 for Nimenrix + Boostrix Group and Boostrix Group and Month 2 for Nimenrix Group)|The analysis was performed on the ATP cohort for immunogenicity will included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccine dose.||Participants|||Count of Participants
665703|NCT01767376|Secondary|Anti-T Antibody Concentrations|The antibody concentrations were tabulated as geometric mean concentrations (GMCs) and expressed as international units per milliliter (IU/mL).|Prior to (i.e. Month 0 for Nimenrix + Boostrix Group and Boostrix Group and Month 1 for Nimenrix Group), one month after Nimenrix vaccination and one month after Boostrix vaccination|The analysis was performed on the ATP cohort for immunogenicity will included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccine dose.||IU/mL||95% Confidence Interval|Geometric Mean
665704|NCT01767376|Secondary|Anti-D Antibody Concentrations|The antibody concentrations were tabulated as geometric mean concentrations (GMCs) and expressed as international units per milliliter (IU/mL).|Prior to (PRE i.e. Month 0 for Nimenrix + Boostrix Group and Boostrix Group and Month 1 for Nimenrix Group) and one month after Boostrix vaccination (POST i.e. Month 1 for Nimenrix + Boostrix Group and Boostrix Group and Month 2 for Nimenrix Group)|The analysis was performed on the ATP cohort for immunogenicity will included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccine dose.||IU/mL||95% Confidence Interval|Geometric Mean
665705|NCT01767376|Secondary|Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies|"rSBA vaccine response for serogroups A, C, W-135 and Y was defined as:
For initially seronegative subjects (pre-vaccination titer below the cut-off of 1:8): number of subjects with rSBA antibody titers ≥ 1:32 one month after vaccination.
For initially seropositive subjects (pre-vaccination titer ≥ 1:8): number of subjects with rSBA antibody titers at least four times the pre-vaccination antibody titers, one month after vaccination."|One month after Nimenrix vaccination (i.e. Month 1 for Nimenrix+Boostrix and Nimenrix Groups and Month 2 for Boostrix Group)|The analysis was performed on the ATP cohort for immunogenicity will included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccine dose.||Participants|||Count of Participants
665706|NCT01767376|Secondary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres Above the Cut-off Values|The reference cut-off values of the assay were rSBA-Men antibody concentrations ≥ 1:128 and ≥ 1:8.|Prior to (i.e. Month 0 for Nimenrix+Boostrix and Nimenrix Groups and Month 1 for Boostrix Group) and one month after Nimenrix vaccination (i.e. Month 1 for Nimenrix+Boostrix and Nimenrix Groups and Month 2 for Boostrix Group)|The analysis was performed on the ATP cohort for immunogenicity will included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccine dose.||Participants|||Count of Participants
665707|NCT01767376|Primary|Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations|The antibody concentrations were tabulated as adjusted geometric mean concentrations (GMCs) and expressed as international units per millilitre (IU/mL). The primary outcome results only refer to Nimenrix+Boostrix Group and Boostrix Group|One month after Boostrix vaccination (i.e. Month 1)|The analysis was performed on the ATP cohort for immunogenicity will included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccine dose.||IU/mL||95% Confidence Interval|Geometric Mean
665824|NCT01766024|Primary|Cmax of Interferon Beta-1a|Primary outcome measure for pharmacokinetics analysis Blood samples were taken before the injection, then after 15 min, 30 min, 45 min, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours and 48 hours.|0 to 48 hours post-dose|||pg/ml||Inter-Quartile Range|Median
665708|NCT01767376|Primary|Number of Subjects With Anti-D and Anti-T Concentrations Above the Cut-off Value|The antibody concentrations were calculated as geometric mean concentrations (GMCs) and expressed as international units per milliliter (IU/mL). The reference cut-off value was an antibody concentration ≥ 1 IU/mL. The primary outcome results only refer to Nimenrix+Boostrix Group and Boostrix Group.|One month after Boostrix vaccination (i.e. Month 1)|The analysis was performed on the ATP cohort for immunogenicity will included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccine dose.||Participants|||Count of Participants
665709|NCT01767376|Primary|Anti-Meningitis Antibody Titers by Serum Bactericidal Assay Using Rabbit Complement (rSBA)|The analysis was performed for the serogroups -MenA, -MenC -MenW-135 and -MenY. Antibody titers tabulated as geometric mean titers (GMTs), were obtained by serum bactericidal assay using rabbit complement and expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). The primary outcome results only refer to Nimenrix+Boostrix Group and Nimenrix Group.|One month after Nimenrix vaccination (i.e. Month 1 for Nimenrix+Boostrix and Nimenrix Groups and Month 2 for Boostrix Group)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity will included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccine dose.||EL.U/mL||95% Confidence Interval|Geometric Mean
665710|NCT01767285|Other Pre-specified|Patient Satisfaction|To identify differences in satisfaction with birth control method between women who have immediate versus delayed (6 weeks) postpartum Implanon® placement.|12 months|Participants who completed the 12 month patient satisfaction assessment.||participants|||Number
665711|NCT01767285|Other Pre-specified|Pregnancy Rate|To identify differences pregnancy rates between women who have immediate versus delayed (6 weeks) postpartum Implanon® placement.|12 months|all participants who completed the 12 month follow up visit||participants|||Number
665712|NCT01767285|Other Pre-specified|Continuation of Breastfeeding|To identify differences in continuation of breast-feeding at 6 months between women who have immediate versus delayed (6 weeks) postpartum Implanon® placement.|6 months|Participants who completed the 6 month assessment.||participants|||Number
665713|NCT01767285|Secondary|Continuation Rate|To identify a difference in continuation rates of Implanon® at one year between women who have the device placed immediately postpartum and women who have the device placed at the 6-week postpartum visit.|6 months|Participants who completed the 6 month assessment.||participants|||Number
665714|NCT01767285|Secondary|Rate of Intercourse|To identify differences in the rates of intercourse prior to the 6-week postpartum visit.|6 weeks|Participants who completed the 6 week assessment.||participants|||Number
665715|NCT01767285|Primary|Continuation Rate|To identify a difference in continuation rates of Implanon® between women who have the device placed immediately postpartum and women who have the device placed at the 6-week postpartum visit.|1 year|Participants who completed the 1 year phone visit were included in analysis.||participants|||Number
665716|NCT01767116|Secondary|Percentage of Participants With Virologic Relapse After Treatment|Participants who completed treatment with plasma HCV RNA less than the lower limit of quantification (<LLOQ) at the end of treatment were considered to have virologic relapse if they had confirmed HCV RNA ≥ LLOQ during the post-treatment period.|Between End of Treatment (Week 12) and Post-treatment (up to Week 12 Post-treatment)|All randomized participants who received at least 1 dose of study drug (ITT population) with HCV RNA < LLOQ at the final treatment visit and completed treatment.||percentage of participants|||Number
665717|NCT01767116|Secondary|Percentage of Participants With Virologic Failure During Treatment|Virologic failure during treatment was defined as rebound (confirmed HCV RNA greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA < LLOQ during treatment, or confirmed increase from the lowest value post baseline in HCV RNA [2 consecutive HCV RNA measurements > 1 log10 IU/mL above the lowest value post baseline] at any time point during treatment), or failure to suppress (HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks [≥ 36 days] of treatment).|Baseline (Day 1), and Treatment Weeks 1, 2, 4, 6, 8, 10, and 12|All randomized participants who received at least 1 dose of study drug (ITT population).||percentage of participants|||Number
665718|NCT01767116|Secondary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Superiority Analyses of Each Treatment Arm Compared to Historical Rate|"The percentage of participants with sustained virologic response (plasma HCV RNA less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.
The secondary efficacy endpoints were superiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333, plus either placebo RBV or RBV) compared with the historical control rate for noncirrhotic, treatment-naïve participants with HCV GT1b treated with telaprevir and pegIFN/RBV."|12 weeks after last dose of study drug|All randomized participants who received at least 1 dose of study drug (ITT population); participants with missing data were counted as non-responders.||percentage of particpants|||Number
665719|NCT01767116|Secondary|Percentage of Participants With Hemoglobin Decrease to Below the Lower Limit of Normal (LLN) At End of Treatment|The percentage of participants with a decrease in hemoglobin from greater than or equal to the lower limit of normal (≥ LLN) at baseline to < LLN at the end of treatment.|Baseline (Day 1) and Week 12 (End of Treatment)|All randomized participants who received at least 1 dose of study drug (ITT population) and had hemoglobin ≥ LLN reference range at baseline.||percentage of participants|||Number
665720|NCT01767116|Secondary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Noninferiority Analysis of ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV Compared With ABT-450/r/ABT-267 and ABT-333, Plus RBV|"The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.
The secondary endpoint was the noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment who received ABT-450/r/ABT-267 and ABT-333, plus placebo RBV compared with those who received ABT-450/r/ABT-267 and ABT-333, plus RBV."|12 weeks after last dose of study drug|All randomized participants who received at least 1 dose of study drug (ITT population); participants with missing data were counted as non-responders.||percentage of participants|||Number
666087|NCT01763827|Secondary|Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
665721|NCT01767116|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Noninferiority Analyses of Each Treatment Arm Compared to Historical Rate|"The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug. The LLOQ for the assay was 25 IU/mL.
The primary efficacy endpoints were noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333, plus either placebo RBV or RBV) compared with the historical control rate for noncirrhotic, treatment-naïve participants with HCV GT1b infection treated with telaprevir and peginterferon/RBV (pegIFN)."|12 weeks after last dose of study drug|All randomized participants who received at least 1 dose of study drug (intent-to-treat [ITT] population); participants with missing data were counted as non-responders.||percentage of participants|||Number
665722|NCT01767103|Primary|Fe% for Urine Deferiprone and Deferiprone 3-O-glucuronide|"Cumulative fraction of Ferriprox dose excreted in urine as deferiprone or deferiprone 3-O-glucuronide. Urine samples were collected at the intervals of -2 to 0 hours pre-dose, and 0-2, 2-4, 4-8, 8-12 ,and 12- 24 hours post-dose.
Note: For unknown reasons, the urine samples for one subject in the moderate hepatic failure group had low or zero volume and there were no measurable levels of deferiprone or its metabolite in any of the samples. Accordingly, the urine PK results were derived both with and without this subject’s data, and are here presented without them (i.e., N=6 rather than 7)."|24-hour interval|The PK Analysis Set consisted of all subjects who had sufficient data to derive at least one PK parameter. The data of one subject in the moderate hepatic failure group were dropped due to low or zero volume of urine samples.||percentage of dose excreted in urine||Standard Deviation|Mean
665723|NCT01767103|Primary|CumAe for Urine Deferiprone and Deferiprone 3-O-glucuronide|"Cumulative amount of deferiprone and deferiprone 3-O-glucuronide excreted in the urine. Urine samples were collected at the intervals of -2 to 0 hours pre-dose, and 0-2, 2-4, 4-8, 8-12 ,and 12- 24 hours post-dose.
Note: For unknown reasons, the urine samples for one subject in the moderate hepatic failure group had low or zero volume and there were no measurable levels of deferiprone or its metabolite in any of the samples. Accordingly, the urine PK results were derived both with and without this subject’s data, and are here presented without them (i.e., N=6 rather than 7)."|24-hour interval|The PK Analysis Set consisted of all subjects who had sufficient data to derive at least one PK parameter. The data of one subject in the moderate hepatic failure group were dropped due to low or zero volume of urine samples.||mg||Standard Deviation|Mean
665724|NCT01767103|Primary|T1/2 for Serum Deferiprone and Deferiprone 3-O-glucuronide|T1/2 was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in subjects with normal hepatic function, mild hepatic impairment, or moderate hepatic impairment. Blood samples were obtained prior to dosing and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 9, 12, 16, and 24 hours post-dose.|24-hour interval|The PK Analysis Set consisted of all subjects who had sufficient data to derive at least one PK parameter||hour||Standard Deviation|Mean
665725|NCT01767103|Primary|AUC0-∞ for Serum Deferiprone and Deferiprone 3-O-glucuronide|AUC (area under the curve) from zero to infinity was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in subjects with normal hepatic function, mild hepatic impairment, or moderate hepatic impairment. Blood samples were obtained prior to dosing and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 9, 12, 16, and 24 hours post-dose.|24-hour interval|The PK Analysis Set consisted of all subjects who had sufficient data to derive at least one PK parameter||ug*hr/mL||Standard Deviation|Mean
665726|NCT01767103|Primary|Tmax for Serum Deferiprone and Deferiprone 3-O-glucuronide|Tmax was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in subjects with normal hepatic function, mild hepatic impairment, or moderate hepatic impairment. Blood samples were obtained prior to dosing and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 9, 12, 16, and 24 hours post-dose.|24-hour interval|The PK Analysis Set consisted of all subjects who had sufficient data to derive at least one PK parameter||hour||Full Range|Median
665727|NCT01767103|Secondary|Safety and Tolerability of Ferriprox in Subjects With or Without Hepatic Impairment.|The number of participants who experienced adverse events following a single dose of Ferriprox, between the time of dosing and the follow-up visit (including any changes of clinical significance in physical examinations, vital signs, 12-lead ECG, and clinical laboratory tests).|Time of dosing until 48 hours post-dose|The Safety Analysis Set consisted of all subjects who received study medication and had at least one safety assessment||participants|||Number
665728|NCT01767103|Primary|Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide|Cmax was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in subjects with normal hepatic function, mild hepatic impairment, or moderate hepatic impairment. Blood samples were obtained prior to dosing and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 9, 12, 16, and 24 hours post-dose.|24-hour interval|The PK Analysis Set consisted of all subjects who had sufficient data to derive at least one PK parameter||ug/mL||Standard Deviation|Mean
665729|NCT01767064|Primary|Inappropriate Antibiotic Prescribing for Patients With Acute Respiratory Infections (ARI)|Using data from electronic health records, we will calculate clinician antibiotic prescribing rates for antibiotic-inappropriate ARI diagnoses: acute nasopharyngitis (ICD-9 460.x), acute laryngitis without obstruction (465.8), acute laryngopharyngitis (465.0), acute bronchitis (466.x), acute upper respiratory infections of other multiple sites (465.8), acute upper respiratory infections not otherwise specified (465.9), bronchitis not specified as acute or chronic (490.x), non-streptococcal pharyngitis (462.xx), and influenza with other respiratory manifestations (487.1). To control for temporal trends in antibiotic prescribing and provider-fixed effects, we will fit a logistic mixed effects model that predicts inappropriate antibiotic prescribing as a function of study arm and an indicator for baseline versus intervention period (a difference-in-differences regression).|up to 12 months post intervention|clinicians||inappropriate prescribing events||95% Confidence Interval|Number
665812|NCT01766037|Primary|Mean Percent Excess Weight Loss (%EWL)|The first effectiveness co-primary endpoint is the mean percent excess weight loss (%EWL) at 52-weeks. The hypothesis for the first primary effectiveness endpoint is that the difference in the mean percent excess weight loss (%EWL) at 52-weeks for the Aspiration Therapy (AT) group and Control group is at least 10%. Percent EWL is defined as absolute weight loss divided by baseline excess weight and multiplied by 100. Excess weight is determined from ideal body weights based on a BMI=25 kg/m2.|52 weeks|Modified Intent To Treat (mITT) population defined as all enrolled subjects||Percent Excess Weight Loss||Standard Deviation|Mean
665730|NCT01766921|Secondary|The Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain|"Immunogenicity was assessed in terms of percentages of subjects achieving seroconversion in HI titers, three weeks after receiving two injections of either low dose or high dose aH5N1c vaccine according to the CHMP criterion.
Seroconversion is defined as a postvaccination titer ≥40 in subjects with a prevaccination HI titer <10; or in subjects with prevaccination HI titer ≥10, a minimum four-fold rise in postvaccination HI antibody titer.
The criterion is met according to the European (CHMP) guideline if the percentage of subjects achieving seroconversion is >30%."|Day 22, day 43 and day 387|Analysis was done on the FAS.||Percentages of subjects||95% Confidence Interval|Number
665731|NCT01766921|Secondary|Percentages Of Subjects With HI Titers ≥40 Against A/H5N1 Strain|"Immunogenicity was assessed in terms of percentage of subjects achieving HI titers >40, three weeks after second vaccination with aH5N1c according to the CHMP criterion.
The European Licensure (CHMP) criterion is met if the percentage of subjects achieving HI titers ≥40 is >60%."|Day 1, day 22, day 43 and day 387.|Analysis was done on the FAS.||Percentages of subjects||95% Confidence Interval|Number
665732|NCT01766921|Secondary|Geometric Mean Ratios (GMR) Against A/H5N1 Strain Following 2-dose Vaccination Schedule of Either Low Dose or High Dose aH5N1c Vaccine.|"Immunogenicity was measured as the GMR. The ratio of postvaccination to prevaccination HI geometric mean titers (GMTs) is reported.
The criterion is met according to the European Committee for Medicinal Products for Human Use (CHMP) criterion if the geometric mean increase GMR (day 43/day 1) in HI antibody titer is >2.0 for subjects >60 years of age."|Day 1; day 22; day 43 and day 387|Analysis was done on the FAS.||Ratio||95% Confidence Interval|Geometric Mean
665733|NCT01766921|Primary|Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination.|Safety was assessed using the number of subjects who reported any unsolicited adverse events, adverse events possibly or probably related to study vaccine, serious adverse events (SAEs), new onset of chronic diseases (NOCDs), medically attended AEs, AEs of special interest (AESIs), AEs leading to withdrawal from study following vaccination with aH5N1c vaccine|Day 1 through day 387 after any vaccination|Analysis was done unsolicited safety population, i.e. subjects in the exposed set with unsolicited AE data.||Number of subjects|||Number
665734|NCT01766921|Primary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination.|Safety was assessed as the number of subjects who reported solicited local and systemic adverse events following vaccination with either low or high dose of aH5N1c vaccine.|From day 1 through day 7 after any vaccination.|Analysis was done on the solicited safety population, i.e. All subjects in the exposed set with solicited (local/systemic) AE data..||Number of subjects|||Number
665735|NCT01766921|Primary|The Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain.|"Immunogenicity was measured in terms of the percentages of subjects achieving seroconversion or significant increase in HI titer against the vaccine strain, three weeks after receiving two injections of low dose or high dose of aH5N1c vaccine according to the CBER criterion.
Seroconversion is defined as, a postvaccination titer ≥40 in subjects with a prevaccination HI titer <10; or in subjects with prevaccination HI titer ≥10, a minimum four-fold rise in postvaccination HI antibody titer.
The CBER criterion for the elderly population is met if the lower limit of the two-sided 95% CI for the percentages of subjects achieving seroconversion for HI antibody titer meets or exceeds 30%."|Three weeks after 2nd vaccination (day 43)|This analysis was done on the FAS.||Percentages of subjects||95% Confidence Interval|Number
665736|NCT01766921|Primary|The Percentages Of Subjects Achieving Hemagglutination Inhibition (HI) Titers ≥40 Against A/H5N1 Strain.|"The optimal aH5N1c vaccine formulation was evaluated in terms of percentages of subjects achieving HI titers ≥40 against homologous A/H5N1 strain, three weeks after second vaccination with either low dose or high dose of aH5N1c vaccine, according to the Center for Biologics Evaluation and Research (CBER) criterion.
The CBER criterion for the elderly population is met if the lower limit of the two-sided 95% confidence interval (CI) for the percentages of subjects achieving HI titer ≥40 meets or exceeds 60%."|Baseline (day 1) and Three weeks after 2nd vaccination (day 43)|Analysis was done on the Full Analysis Set (FAS) i.e., subjects who actually receive at least one dose of study vaccination and provide at least one evaluable serum sample both before (baseline) and after vaccination.||Percentages of subjects||95% Confidence Interval|Number
665737|NCT01766778|Secondary|Number of Patients With Adverse Events, Serious Adverse Events and Death as an Assessment of Overall Safety and Tolerability|This analysis reported percentage patients with adverse events and patient discontinued from the study due to adverse events. Aslo, percentage of patients with serious adverse events and death was reported.|Month 12|Intent to treat (ITT) analysis set included all randomized patients who received at least one dose of study medication.||Patients|||Number
665738|NCT01766778|Secondary|Percentage of Overall Drug Compliance in 12 Months|The overall drug compliance (%) = (Observed Consumption / Expected Consumption) x 100% Where (Observed Consumption / Expected Consumption) = [1- (Number of missing tablets from all visits/(sum of Allocated Daily Dosage (in tablets) from all visits × No. of Days between the Date Dispensed and the Date Returned))]|Month 12|Intent to treat (ITT) analysis set included all randomized patients who received at least one dose of study medication. Patients who had reported dosing compliance were included in this analysis.||Percentage of overall drug compliance||Standard Deviation|Mean
665739|NCT01766778|Secondary|Percentage of Patients Achieving Good Glycemic Control|Blood samples were collected to analyze HbA1c. Good glycemic control is defined as patient achieving Hb1Ac < 7.0%. Percentage of patients who achieved HbA1c less than 7.0% at month 3, 6, 9 and 12 were reported for this endpoint.|Month 3, 6, 9, 12|Intent to treat (ITT) analysis set included all randomized patients who received at least one dose of study medication. 'n' indicates patients with HbA1c data in that time point.||Percentage of patients|||Number
665740|NCT01766778|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Month 3, 6, 9 and 12 (Based on MMRM Analysis)|Blood samples were collected to analyze fasting plasma glucose. Mixed Model of Repeated Measures (MMRM) was used to analyze this outcome. For the MMRM analysis, the model included terms for treatment, period, treatment-by-period interaction and baseline value, and further adjusted by pre-existing hypertension. The variable selected for baseline adjustment was based on the lowest AIC.|Baseline, Month 3, 6, 9 and 12|Intent to treat (ITT) analysis set included all randomized patients who received at least one dose of study medication.||mmol/L||Standard Error|Least Squares Mean
665813|NCT01766024|Secondary|Study Withdrawal Rate Due to AE|Secondary outcome measure for safety assessment|up to Day 43||||||
665814|NCT01766024|Secondary|Local Reaction Incidence|Secondary outcome measure for tolerability assessment|up to Day 43||||||
665741|NCT01766778|Secondary|Change of Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Month 3, 6, 9 and 12 (Based on MMRM Analysis)|HbA1c is an integrated measure of average glucose concentration in plasma in the last 2-3 months. Blood samples were collected to analyze HbA1c. Mixed Model of Repeated Measures (MMRM) was used to analyze this outcome. For the MMRM analysis, the model includes terms for treatment, period, treatment-by-period interaction and baseline value, and further adjusted by age, pre-existing hypertension and microvascular and macrovascular complications for diabetes mellitus. The variables selected for baseline adjustment were based on the lowest AIC.|Baseline, Month 3, 6, 9 and 12|Intent to treat (ITT) analysis set included all randomized patients who received at least one dose of study medication. .||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
665742|NCT01766778|Primary|Change of Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Month 12|HbA1c is an integrated measure of average glucose concentration in plasma in the last 2-3 months. Blood samples were collected to analyze HbA1c|Baseline, Month 12 (weeK 52)|Intent to treat (ITT) analysis set included all randomized patients who received at least one dose of study medication. Patients with both baseline and 12 month data were included in this analysis||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
665743|NCT01766713|Primary|Change in Liver Fat as Measured by MRI-PDFF||24 weeks|compared to baseline, end of treatment MRI-PDFF||percentage of total fat||Standard Deviation|Mean
665744|NCT01766466|Primary|Extent of Aggregation Response During Ticagrelor Treatment|"Blood samples were taken for platelet function studies to conduct pharmacodynamic assessments including LTA.
A reference point was chosen for comparison and designated the first draw during the cangrelor infusion (0.5 hours or 1.25 hours) as the reference for the effect of cangrelor and designated the final draw on study Day 1 (5.25 hours, or 3.25 hours after cangrelor had been discontinued) as the reference for the effect of ticagrelor.
Residual platelet reactivity (PR) (the extent of aggregation in the presence or absence of the study drugs) was examined for each of the endpoints using light transmittance aggregometry. Residual platelet reactivity was measured in response to 20 µmol ADP at 300 seconds (final/terminal aggregation response)."|Day 1 at 2.25, 2.5, 2.75, 3 and 4 hrs following initiation of cangrelor infusion|||percentage of platelet reactivity (PR)||Standard Deviation|Mean
665745|NCT01766466|Primary|Extent of Preservation of Inhibitory Effect Compared With Effect Observed During Cangrelor Treatment After Ticagrelor|"A reference point was chosen for comparison and designated the first draw during the cangrelor infusion (0.5 hours or 1.25 hours) as the reference for the effect of cangrelor.
Residual platelet reactivity (the extent of aggregation in the presence or absence of the study drugs) was examined for each of the endpoints using light transmittance aggregometry (LTA). Residual platelet reactivity (PR) was measured in response to 20 µmol ADP at 300 seconds (final/terminal aggregation response)."|Day 5 at 1.0 and 2.0 hours after the initiation of cangrelor infusion|||percentage of platelet reactivity (PR)||Standard Deviation|Mean
665746|NCT01766466|Primary|Extent of Preservation of Inhibitory Effect Compared With Effect Observed With Cangrelor Alone (at Timepoint 1, Either at 0.5 Hours or 1.25 Hours) or Ticagrelor Alone (Measured 5.25 Hours After Initiation of Cangrelor on Day 1)|A reference point was chosen for comparison and designated the first draw during the cangrelor infusion (0.5 hours or 1.25 hours) as the reference for the effect of cangrelor and designated the final draw on study Day 1 (5.25 hours, or 3.25 hours after cangrelor had been discontinued) as the reference for the effect of ticagrelor. Residual platelet reactivity (the extent of aggregation in the presence or absence of the study drugs) was examined for each of the endpoints using light transmittance aggregometry. Residual platelet reactivity (PR) was measured in response to 20 µmol adenosine diphosphate (ADP) at 300 seconds (final/terminal aggregation response).|Day 1 measures taken at 2 timepoints after cangrelor infusion start: 0.5 or 1.5 hrs (Timepoint 1) and 5.25 hrs (TImepoint 2)|||percentage of platelet reactivity (PR)||Standard Deviation|Mean
665747|NCT01766440|Primary|AUC (0-12h) of Calcitriol Plasma Level|AUC (0-12h) of calcitriol plasma level at Day 14 (For subjects with a body weight of < 15 kg, AUC (0-9h) was extrapolated based on the pre-dose to 6 hours post dose PK samples. For subjects with a body weight of ≥ 15 kg, AUC (0-12h) was extrapolated based on the pre-dose to 9 hours post-dose PK samples.)|Day 14|Safety population: All enrolled subjects having received the treatment at least once.||pg*h/mL||Standard Deviation|Mean
665748|NCT01766440|Primary|AUC (0-9h) of Calcitriol Plasma Level|AUC (0-9h) of calcitriol plasma level at Day 14 (Pre-dose to 9 hours post-dose. For subjects with a body weight of <15 kg, AUC (0-9h) was extrapolated based on the pre-dose to 6 hours post-dose PK samples.)|Day 14|Safety population: All enrolled subjects having received the treatment at least once.||pg*h/mL||Standard Deviation|Mean
665749|NCT01766440|Primary|AUC (0-6h) of Calcitriol Plasma Level|AUC (0-6h) of calcitriol plasma level at Day 14 (Pre-dose to 6 hours post-dose)|Day 14|Safety population: All enrolled subjects having received the treatment at least once.||pg*h/mL||Standard Deviation|Mean
665750|NCT01766440|Primary|Tmax of Calcitriol Plasma Level|Tmax of calcitriol plasma level at Day 14|Day 14|Safety population: All enrolled subjects having received the treatment at least once.||hour||Standard Deviation|Mean
665751|NCT01766440|Primary|Cmin of Calcitriol Plasma Level|Cmin of calcitriol plasma level at Day 14|Day 14|Safety population: All enrolled subjects having received the treatment at least once.||pg/mL||Standard Deviation|Mean
665752|NCT01766440|Primary|Cmax of Calcitriol Plasma Level|Cmax of calcitriol plasma level at Day 14 (Peak plasma concentration of calcitriol from Day 1 to Day 14)|Day 14|Safety population: All enrolled subjects having received the treatment at least once.||pg/mL||Standard Deviation|Mean
665753|NCT01766336|Primary|Number of Participants Experiencing Treatment Emergent Adverse Events|To evaluate the safety and tolerability of ELND005 treatment with up to 36 weeks exposure, in Moderate to Severe AD patients with agitation and aggression.|36 weeks|||participants|||Number
665754|NCT01766310|Other Pre-specified|Prevalence of Hyperhomocysteinemia|prevalence of hyperhomocysteinemia in Thai obese children|8 weeks|||participants|||Number
665755|NCT01766310|Secondary|Serum Vitamin B12 Level|correlation between serum vitamin B12 and plasma homocysteine level|8 weeks||||||
665756|NCT01766310|Secondary|Serum Folate Level|correlation between serum folate and plasma homocysteine level|8 weeks||||||
665757|NCT01766310|Primary|Changes of Homocysteine Level|Mean difference of changes of homocysteine level between 2 treatment groups|8 weeks|||µmol/L||Standard Deviation|Mean
665815|NCT01766024|Secondary|AE of Garde 3-4 Incidence|Secondary outcome measure for safety assessment|up to Day 43||||||
665816|NCT01766024|Secondary|Adverse Event (AE) and Serious Adverse Event (SAE) Incidence|Secondary outcome measure for safety assessment|up to Day 43||||||
665758|NCT01766102|Secondary|Assessment of Radiographic and Pathologic Findings|"Assessment of radiographic findings and pathologic findings to determine sensitivity, specificity, positive predictive value, and negative predictive values of intra-operative digital specimen mammography (ISM) and standard specimen mammography for determining margin status.
A true positive (TP) was defined as a positive margin by imaging (ISM or SSM) and pathology
A false positive (FP) was defined as a positive margin by imaging but negative by pathology
A true negative (TN) was defined as a negative margin by both imaging and pathology.
A false negative (FN) was defined as a negative margin by imaging but positive by pathology
The sensitivity [TP/(TP + FN)], specificity [TN/(TN + FP)], positive predictive value [TP/ (TP + FP)], and negative predictive value [TN/(TN + FN)] for identification of positive margins were calculated for ISM and SSM."|2 years|Interpretation of margin status by the surgeon was available for 22 of 36 ISM patients. Interpretation of margin status was also available for 22 of 36 SSM patients.||Percent|||Number
665759|NCT01766102|Primary|Comparison of Operative Time Savings|To compare the overall operative time savings using intra-operative digital mammography compared with standard specimen mammography.|At the time of the procedure (approximately 1 week after randomization)|||Minutes||Full Range|Median
665760|NCT01766076|Primary|Percentage Change in Immune Activation Levels After 12 Weeks of Atorvastatin 80mg Daily|Immune activation was measured by co-expression of CD38 and HLADR on CD4 T-cells (CD4+CD38+HLADR+) Mean percentage change at 12 weeks was calculated|12 weeks|There was no cross-over or carry-over effect (the sequence did not matter), so we present data for 30 patients for their 12 weeks exposure to atorvastatin||percentage change in activated T-cells||Inter-Quartile Range|Median
665761|NCT01766050|Secondary|Mean Change From Baseline in Heart Rate at Study Discharge (Day 46±2 Days)|Heart Rate was taken after the participant had been sitting quietly for at least 5 minutes and was measured in beats per minute (bpm). Hear rate was taken on Day 46 (day of discharge) during the follow up period. Baseline was defined as last non-missing result with a collection date-time less than the date-time of the first active dose of study drug.|Baseline and Day 46 ±2 days|All participants who received study drug during the treatment period and had measurements at baseline and discharge.||bpm||Standard Deviation|Mean
665762|NCT01766050|Secondary|Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Study Discharge (Day 46±2 Days)|Systolic and Diastolic blood pressures were taken after the participant had been sitting quietly for at least 5 minutes and the pressures were measured in millimeters of mercury (mm Hg). Systolic and Diastolic blood pressures were taken on Day 46 (day of discharge from the study). Baseline was defined as last non-missing result with a collection date-time less than the date-time of the first active dose of study drug.|Baseline and Day 46 ±2 days|All participants who had received study drug during the treatment period and had measurements at baseline and at discharge.||mm Hg||Standard Deviation|Mean
665763|NCT01766050|Secondary|Mean Change From Baseline in Sitting Heart Rate - All Treated Participants|Heart Rate was taken after the participant had been sitting quietly for at least 5 minutes and the heart rate was measured in beats per minute (bpm). Heart Rates were obtained at screening visit, Day -1, and at 0 hour (pre-dose), 0.5 hour (post dose), and 2 hours (post dose) on Days 1, 4, 7, 11. Baseline was defined as last non-missing result with a collection date-time less than the date-time of the first active dose of study drug.|Baseline and 0.5 and 2.0 hours Post Dose on Days 1, 4, 7, and 11|All participants who received study medication and had baseline and specific day measurement.||bpm||Standard Deviation|Mean
665764|NCT01766050|Secondary|Mean Change From Baseline in Sitting Systolic and Diastolic Blood Pressure - All Treated Participants|Systolic and Diastolic blood pressures were taken after the participant had been sitting quietly for at least 5 minutes and the pressures were measured in millimeters of mercury (mm Hg). Pressures were obtained at screening visit, Day -1, and at 0 hour (pre-dose), 0.5 hour (post dose), and 2 hours (post dose) on Days 1, 4, 7, 11. Baseline was defined as last non-missing result with a collection date-time less than the date-time of the first active dose of study drug.|Baseline and 0.5 and 2.0 hours Post Dose on Days 1, 4, 7, and 11|All participants who received any study medication and had a baseline and specific day blood pressure measurement available.||mm Hg||Standard Deviation|Mean
665765|NCT01766050|Secondary|Number of Participants With Out-of-Range Electrocardiogram Intervals - All Treated Participants|Participants had 12-Lead electrocardiograms (ECGs) performed at Screening Visit, Day 1 prior to dosing, Day 46 ±2, and at early termination. Definition of out-of-range: PR Interval >210 milliseconds (msec); QRS > 120 msec, QT > 500 msec or > 30 msec change from baseline (Day 1); QT with Fridericia correction (QTcF) > 450 msec or change from baseline of > 30 msec to <= 60 msec or change from baseline > 60 msec.|Day 1 to Day 46 ±2 days or at early termination|All participants who received any study medication and had an ECG performed on Day 1, Day 46 or early termination.||participants|||Number
665766|NCT01766050|Secondary|Number of Participants With Marked Hematology and Urinalysis Laboratory Abnormalities - All Treated Participants|Samples for laboratory tests were obtained at Screening visit, Day -1 or prior to dosing on Day 1, Days 3, 6, 10, 46 ±2, and at early termination, after 10 hours fasting. Leukocytes: *10^9 cells per liter (c/L) < 0.85*Pre-Rx if Pre-Rx < LLN or <0.9*LLN if LLN <= Pre-Rx or Pre-Rx is missing. Neutrophils (absolute): *10^12 c/L < 0.85* Pre-Rx if Pre-Rx < 1.5, <1.5 if Pre-Rx >= 1.5, < 1.5 if Pre-Rx missing. Urine blood from dipstick: >=2 if Pre-Rx <1 or was missing or if Pre-Rx >=1. Urinary microscopic white blood cells (WBC) and red blood cells (RBC) >= 2 if Pre-Rx <2 or if Pre-Rx was missing or >=4 if Pre-Rx >=2.|Day -1 to Day 46 ±2 days or at early termination|Participants who received any study medication and had laboratory test results.||participants|||Number
665767|NCT01766050|Secondary|Number of Participants With Marked Serum Chemistry Laboratory Abnormalities - All Treated Participants|Samples for laboratory tests were obtained at Screening visit, Day -1 or prior to dosing on Day 1, Days 3, 6, 10, 46, and at early termination, after 10 hours fasting. Upper limits of normal (ULN); Lower limits of normal (LLN); Pre-therapy (Rx); micromoles per liter (µmol/L); millimoles per liter (mmol/L); grams per liter (g/L); Units per liter (U/L); Aspartate Aminotransferase (AST); Blood Urea Nitrogen (BUN) Total Bilirubin: >1.1*ULN if Pre-Rx<= ULN or Pre-Rx is missing, or >1.2*Pre-Rx if Pre-Rx >ULN. AST: >1.25*Pre-Rx if Pre-Rx >ULN or 1.25*ULN if Pre-Rx <= ULN or Pre-Rx is missing. BUN: >1.1*ULN if Pre-Rx<= ULN or Pre-Rx is missing, or >1.2*Pre-Rx if Pre-Rx >ULN. Phosphorus: <0.85*LLN if Pre-RX >= LLN or is missing or if Pre-Rx < LLN. total Protein: <0.9*LLN if Pre-Rx>= LLN or is missing or Pre-Rx > LLN. Creatine Kinase: >1.5*Pre-Rx if Pre-Rx > ULN or is missing or Pre-Rx is <= ULN. Lactate Dehydrogenase: >1.25*ULN if Pre-Rx <= ULN or missing, >1.5*Pre-Rx if Pre-Rx > ULN.|Day -1 to Day 46 ±2 days or at early termination|Participants who received any study medication and had laboratory test results.||participants|||Number
665768|NCT01766050|Secondary|Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and AEs Leading to Discontinuation - All Treated Participants|Adverse events were coded according to the Medical Dictionary for Regulatory Activities (MedDRA), version 15.1. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Events captured from Day 1 (pre-dose) to last day prior to discharge (Day 46 ±2). In the total group, a participant with an AE is only counted once (ie, data reflected in Days 1, 4, 7, and 11 below could be the same participant with an AE on multiple days of the study).|Day 1 to Day of discharge (Day 46±2)|All participants who received any study medication.||participants|||Number
665769|NCT01766050|Secondary|Ratio of 1'-Hydroxy-Midazolam (Cmax) to Midazolam (Cmax), Corrected for Molecular Weight (MR_Cmax) With and Without Coadministration of Belatacept - PK Evaluable Population|Metabolite (1'-hydroxy-midazolam) to parent (midazolam) ratio was corrected for molecular weight. Cmax measured in ng/mL. Samples for assessment of plasma concentrations of Inje cocktail components and the metabolites of those components were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Inje cocktail components were each measured using HPLC with MS/MS detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).||ratio||Geometric Coefficient of Variation|Geometric Mean
665770|NCT01766050|Primary|Adjusted Geometric Mean AUC (0-T) and AUC (INF) of Caffeine With and Without the Coadministration of Belatacept - PK Evaluable Population|Samples for assessment of plasma concentrations of Inje cocktail components (midazolam, losartan, omeprazole, dextromethorphan and caffeine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Inje cocktail components were each measured using HPLC with MS/MS detection. AUC (0-T) and AUC (INF) were measured as ng*h/mL.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).||ng*h/mL||90% Confidence Interval|Geometric Mean
665771|NCT01766050|Primary|Adjusted Geometric Mean Cmax of Caffeine With and Without the Coadministration of Belatacept - PK Evaluable Population|Samples for assessment of plasma concentrations of Inje cocktail components (midazolam, losartan, omeprazole, dextromethorphan and caffeine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Inje cocktail components were each measured using HPLC with MS/MS detection. Cmax was measured in ng/mL.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).||ng/mL||90% Confidence Interval|Geometric Mean
665772|NCT01766050|Primary|Adjusted Geometric Mean AUC (0-T) and AUC (INF) of Dextromethorphan With and Without the Coadministration of Belatacept - PK Evaluable Population|AUC(0-T): area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration and AUC (INF): AUC extrapolated to infinity, were measured as ng*h/mL. Samples for assessment of plasma concentrations of Inje cocktail components (midazolam, losartan, omeprazole, dextromethorphan and caffeine) and their metabolites (1'-hydroxy-midazolam, E-3174, 5-hydroxyomeprazole, dextrorphan, and paraxanthine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Adjusted geometric mean for dextromethorphan with and without belatacept, along with adjusted geometric mean ratios for Days 4, 7, and 11 versus Day 1, respectively, are presented. The poor metabolizer of CYP2D6 was excluded from the statistical analysis. Inje cocktail components (dextromethorphan) measured using HPLC with MS/MS Detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).||ng*h/mL||90% Confidence Interval|Geometric Mean
665773|NCT01766050|Primary|Adjusted Geometric Mean Cmax of Dextromethorphan With and Without the Coadministration of Belatacept - PK Evaluable Population|Cmax was measured in ng/mL. Samples for assessment of plasma concentrations of Inje cocktail components (midazolam, losartan, omeprazole, dextromethorphan and caffeine) and their metabolites (1'-hydroxy-midazolam, E-3174, 5-hydroxyomeprazole, dextrorphan, and paraxanthine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Adjusted geometric mean for dextromethorphan with and without belatacept, along with adjusted geometric mean ratios for Days 4, 7, and 11 versus Day 1, respectively, are presented. The poor metabolizer of CYP2D6 was excluded from the statistical analysis. Inje cocktail components (dextromethorphan) measured using HPLC with MS/MS Detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).||ng/mL||90% Confidence Interval|Geometric Mean
665780|NCT01766050|Secondary|Ratio of 5-Dextrorphan (Cmax) to Dextromethorphan (Cmax), Corrected for Molecular Weight (MR_Cmax) With and Without Coadministration of Belatacept - PK Evaluable Population|Metabolite (5-dextrorphan) to parent (dextromethorphan) ratio was corrected for molecular weight. Cmax measured in ng/mL. Samples for assessment of plasma concentrations of Inje cocktail components and the metabolites of those components were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. The poor metabolizer of CYP2D6 was excluded from summary of Dextrorphan parameters. Inje cocktail components were each measured using HPLC with MS/MS detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).||ratio||Geometric Coefficient of Variation|Geometric Mean
665817|NCT01766024|Secondary|Tmax of Neopterin and MxA Protein|Secondary outcome measure for pharmacodynamics analysis|0 to 168 hours post-dose||||||
665774|NCT01766050|Primary|Adjusted Geometric Mean AUC (0-T) and AUC (INF) of Omeprazole With and Without the Coadministration of Belatacept - Pharmacokinetic (PK) Evaluable Population|AUC(0-T): Area under the plasma concentration-time curve from time zero zero to the time of the last quantifiable concentration and AUC (INF): AUC extrapolated to infinity were measured in ng*h/mL. Samples for assessment of plasma concentrations of Inje cocktail components (midazolam, losartan, omeprazole, dextromethorphan and caffeine) and their metabolites (1'-hydroxy-midazolam, E-3174, 5-hydroxyomeprazole, dextrorphan, and paraxanthine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Adjusted geometric mean for omeprazole with and without belatacept, along with adjusted geometric mean ratios for Days 4, 7, and 11 versus Day 1, respectively, are presented. Inje cocktail components (omeprazole) measured using HPLC with MS/MS Detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).||ng*h/mL||90% Confidence Interval|Geometric Mean
665775|NCT01766050|Primary|Adjusted Geometric Mean Cmax of Omeprazole With and Without the Coadministration of Belatacept - Pharmacokinetic (PK) Evaluable Population|Cmax: Maximum observed plasma concentration was measured in ng/mL. Samples for assessment of plasma concentrations of Inje cocktail components (midazolam, losartan, omeprazole, dextromethorphan and caffeine) and their metabolites (1'-hydroxy-midazolam, E-3174, 5-hydroxyomeprazole, dextrorphan, and paraxanthine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Adjusted geometric mean for omeprazole with and without belatacept, along with adjusted geometric mean ratios for Days 4, 7, and 11 versus Day 1, respectively, are presented. Inje cocktail components (omeprazole) measured using HPLC with MS/MS Detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).||ng/mL||90% Confidence Interval|Geometric Mean
665776|NCT01766050|Primary|Adjusted Geometric Mean AUC (0-T) and AUC (INF) of Losartan With and Without the Coadministration of Belatacept - Pharmacokinetic (PK) Evaluable Population|AUC (0-T): area under the concentration curve from time 0 to the time of the last quantifiable concentration and AUC (INF) extrapolated to infinity were measured in ng*h/mL. Samples for assessment of plasma concentrations of Inje cocktail components (midazolam, losartan, omeprazole, dextromethorphan and caffeine) and their metabolites (1'-hydroxy-midazolam, E-3174, 5-hydroxyomeprazole, dextrorphan, and paraxanthine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Adjusted geometric mean for losartan with and without belatacept, along with adjusted geometric mean ratios for Days 4, 7, and 11 versus Day 1, respectively, are presented. Inje cocktail components (losartan) measured using HPLC with MS/MS Detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).||ng*h/mL||90% Confidence Interval|Geometric Mean
665777|NCT01766050|Primary|Adjusted Geometric Mean Cmax of Losartan With and Without the Coadministration of Belatacept - PK Evaluable Population|Cmax measured in ng/mL. Samples for assessment of plasma concentrations of Inje cocktail components (midazolam, losartan, omeprazole, dextromethorphan and caffeine) and their metabolites (1'-hydroxy-midazolam, E-3174, 5-hydroxyomeprazole, dextrorphan, and paraxanthine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Adjusted geometric mean for losartan with and without belatacept, along with adjusted geometric mean ratios for Days 4, 7, and 11 versus Day 1, respectively, are presented. Inje cocktail components (losartan) measured using HPLC with MS/MS Detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).||ng/mL||90% Confidence Interval|Geometric Mean
665778|NCT01766050|Primary|Adjusted Geometric Mean Area Under the Concentration Time Curve (AUC) From Zero to Last Concentration (0-T) and AUC Extrapolated to Infinity (INF) of Midazolam With and Without the Coadministration of Belatacept - Pharmacokinetic (PK) Evaluable Population|AUC(0-T): area under the plasma concentration-time curve from zero to the last time of the last quantifiable concentration and AUC (INF): AUC from time zero extrapolated to infinite time were measured in ng*h/mL. Samples for the assessment of plasma concentrations of Inje cocktail components (midazolam, losartan, omeprazole, dextromethorphan and caffeine) and their metabolites (1'-hydroxy-midazolam, E-3174, 5-hydroxyomeprazole, dextrorphan, and paraxanthine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Adjusted geometric mean for midazolam with and without belatacept, along with adjusted geometric mean ratios for Days 4, 7, and 11 versus Day 1, respectively, are presented. Midazolam measured using HPLC with MS/MS Detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).||ng*h/mL||90% Confidence Interval|Geometric Mean
665779|NCT01766050|Secondary|Ratio of 1’-Hydroxy-Midazolam AUC(0-T) to Midazolam AUC(0-T) and 1’-Hydroxy-Midazolam AUC(INF) to Midazolam AUC(INF), Corrected for Molecular Weight [MR_AUC(0-T), MR_AUC (INF)] With and Without Coadministration of Belatacept - PK Evaluable Population|Metabolite (1’-hydroxy-midazolam) to parent (midazolam) ratio was corrected for molecular weight. AUC (0-T) and AUC (INF) measured in ng*h/mL. Samples for assessment of plasma concentrations of Inje cocktail components and the metabolites of those components were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Inje cocktail components were each measured using HPLC with MS/MS detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).||ratio||Geometric Coefficient of Variation|Geometric Mean
666088|NCT01763827|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
665781|NCT01766050|Secondary|Ratio of 5-Dextrorphan AUC(0-T) to Dextromethorphan AUC(0-T) and 5-Dextrorphan AUC(INF) to Dextromethorphan AUC(INF), Corrected for Molecular Weight [MR_AUC(0-T), MR_AUC (INF)] With and Without Coadministration of Belatacept - PK Evaluable Population|Metabolite (5-dextrorphan ) to parent (dextromethorphan) ratio was corrected for molecular weight. AUC (0-T) and AUC (INF) measured in ng*h/mL. Samples for assessment of plasma concentrations of Inje cocktail components and the metabolites of those components were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. The poor metabolizer of CYP2D6 was excluded from summary of Dextrorphan parameters. Inje cocktail components were each measured using HPLC with MS/MS detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).||ratio||Geometric Coefficient of Variation|Geometric Mean
665782|NCT01766050|Secondary|Ratio of 5-Hydroxyomeprazole (Cmax) to Omeprazole (Cmax), Corrected for Molecular Weight (MR_Cmax) With and Without Coadministration of Belatacept - PK Evaluable Population|Metabolite (5-hydroxyomeprazole) to parent (omeprazole) ratio was corrected for molecular weight. Cmax measured in ng/mL. Samples for assessment of plasma concentrations of Inje cocktail components and the metabolites of those components were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Inje cocktail components were each measured using HPLC with MS/MS detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).||ratio||Geometric Coefficient of Variation|Geometric Mean
665783|NCT01766050|Secondary|Ratio of 5-Hydroxyomeprazole AUC(0-T) to Omeprazole AUC(0-T) and 5-Hydroxyomeprazole AUC(INF) to Omeprazole AUC(INF) , Corrected for Molecular Weight [MR_AUC(0-T), MR_AUC(INF)] With and Without Coadministration of Belatacept - PK Evaluable Population|Metabolite (5-Hydroxyomeprazole) to parent (omeprazole) ratio was corrected for molecular weight. AUC (0-T) and AUC (INF) measured in ng*h/mL. Samples for assessment of plasma concentrations of Inje cocktail components and the metabolites of those components were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Inje cocktail components were each measured using HPLC with MS/MS detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).||ratio||Geometric Coefficient of Variation|Geometric Mean
665784|NCT01766050|Secondary|Ratio of E-3174 (Cmax) to Losartan (Cmax), Corrected for Molecular Weight (MR_Cmax) With and Without Coadministration of Belatacept - PK Evaluable Population|Metabolite (E-3174) to parent (losartan) ratio was corrected for molecular weight. Cmax measured in ng/mL. Samples for assessment of plasma concentrations of Inje cocktail components and the metabolites of those components were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Inje cocktail components were each measured using HPLC with MS/MS detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).||ratio||Geometric Coefficient of Variation|Geometric Mean
665785|NCT01766050|Secondary|Ratio of E-3174 AUC(0-T) to Losartan AUC(0-T) and E3174 AUC (INF) to Losartan AUC (INF) Corrected for Molecular Weight [MR_AUC(0-T), MR_AUC(INF)] With and Without Coadministration of Belatacept - PK Evaluable Population|Metabolite (E-3174) to parent (losartan) ratio was corrected for molecular weight. AUC (0-T) and AUC (INF) measured in ng*h/mL. Samples for assessment of plasma concentrations of Inje cocktail components and the metabolites of those components were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Inje cocktail components were each measured using HPLC with MS/MS detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).||ratio||Geometric Coefficient of Variation|Geometric Mean
665786|NCT01766050|Secondary|Ratio of Paraxanthine (Cmax) to Caffeine (Cmax), Corrected for Molecular Weight (MR_Cmax) With and Without Coadministration of Belatacept - PK Evaluable Population|Metabolite (paraxanthine) to parent (caffeine) ratio was corrected for molecular weight. Cmax measured in ng/mL. Samples for assessment of plasma concentrations of Inje cocktail components and their metabolites were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Inje cocktail components were each measured using HPLC with MS/MS detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).||ratio||Geometric Coefficient of Variation|Geometric Mean
665787|NCT01766050|Secondary|Ratio of Paraxanthine AUC(0-T) to Caffeine AUC(0-T) and Paraxanthine AUC (INF) to Caffeine AUC (INF), Corrected for Molecular Weight [MR_AUC(0-T) and MR_AUC (INF)] With and Without Coadministration of Belatacept - PK Evaluable Population|Metabolite (paraxanthine) to parent (caffeine) ratio was corrected for molecular weight. AUC (0-T) and AUC (INF) measured in ng*h/mL. Samples for assessment of plasma concentrations of Inje cocktail components and the metabolites of those components were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Inje cocktail components were each measured using HPLC with MS/MS detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).||ratio||Geometric Coefficient of Variation|Geometric Mean
665818|NCT01766024|Secondary|Cmax of Neopterin and MxA Protein Blood Samples Were Taken Before the Injection, Then After 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 Hours.|Secondary outcome measure for pharmacodynamics analysis|0 to 168 hours post-dose||||||
665788|NCT01766050|Secondary|T-HALF of Inje Cocktail Component Metabolites (1'-Hydroxy-Midazolam, E-3174, 5-Hydroxyomeprazole, Dextrorphan, and Paraxanthine) With and Without the Coadministration of Belatacept - PK Evaluable Population|Plasma half-life (T-HALF) was measured in hours (h). Samples for assessment of plasma concentrations of Inje cocktail components metabolites (1'-hydroxy-midazolam, E-3174, 5-hydroxyomeprazole, dextrorphan, and paraxanthine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. The poor metabolizer of CYP2D6 was excluded from summary of Dextrorphan parameters. Inje cocktail components were each measured using HPLC with MS/MS detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).||h||Standard Deviation|Mean
665789|NCT01766050|Secondary|Tmax of Inje Cocktail Component Metabolites (1'-Hydroxy-Midazolam, E-3174, 5-Hydroxyomeprazole, Dextrorphan, and Paraxanthine) With and Without the Coadministration of Belatacept - PK Evaluable Population|Samples for assessment of plasma concentrations of Inje cocktail components metabolites (1'-hydroxy-midazolam, E-3174, 5-hydroxyomeprazole, dextrorphan, and paraxanthine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. The poor metabolizer of CYP2D6 was excluded from summary of Dextrorphan parameters. Inje cocktail components were each measured using HPLC with MS/MS detection. Time of maximum observed plasma concentration (Tmax) was measured in hours (h).|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).||h||Full Range|Median
665790|NCT01766050|Secondary|AUC(INF) of Inje Cocktail Component Metabolites (1'-Hydroxy-Midazolam, E-3174, 5-Hydroxyomeprazole, Dextrorphan, and Paraxanthine) With and Without Coadministration of Belatacept - PK Evaluable Population|Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] was measured in ng*h/mL. Samples for assessment of plasma concentrations of Inje cocktail components metabolites (1'-hydroxy-midazolam, E-3174, 5-hydroxyomeprazole, dextrorphan, and paraxanthine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. The poor metabolizer of CYP2D6 was excluded from summary of Dextrorphan parameters. Inje cocktail components were each measured using HPLC with MS/MS detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
665791|NCT01766050|Secondary|AUC(0-T) of Inje Cocktail Component Metabolites (1'-Hydroxy-Midazolam, E-3174, 5-Hydroxyomeprazole, Dextrorphan, and Paraxanthine) With and Without Coadministration of Belatacept - PK Evaluable Population|Area under the plasma concentration-time curve from zero to the last time of the last quantifiable concentration [AUC(0-T)] was measured in ng*h/mL. Samples for assessment of plasma concentrations of Inje cocktail components metabolites (1'-hydroxy-midazolam, E-3174, 5-hydroxyomeprazole, dextrorphan, and paraxanthine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. The poor metabolizer of CYP2D6 was excluded from summary of Dextrorphan parameters. Inje cocktail components were each measured using HPLC with MS/MS detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
665792|NCT01766050|Secondary|Cmax of Inje Cocktail Metabolites (1’-Hydroxy-Midazolam, E-3174, 5-Hydroxyomeprazole, Dextrorphan, and Paraxanthine) With and Without Coadministration of Belatacept - PK Evaluable Population|Samples for assessment of plasma concentrations of Inje cocktail component metabolites (1'-hydroxy-midazolam, E-3174, 5-hydroxyomeprazole, dextrorphan, and paraxanthine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. The poor metabolizer of CYP2D6 was excluded from summary of Dextrorphan parameters. Inje cocktail component metabolites were each measured using HPLC with MS/MS detection. Cmax was measured in ng/mL.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).||ng/mL||Geometric Coefficient of Variation|Geometric Mean
665793|NCT01766050|Secondary|Apparent Total Body Clearance (CLT/F) of the Inje Cocktail Components (Midazolam, Losartan, Omeprazole, Dextromethorphan and Caffeine) With and Without Coadministration of Belatacept - PK Evaluable Population|Samples for assessment of plasma concentrations of Inje cocktail components (midazolam, losartan, omeprazole, dextromethorphan and caffeine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. The poor metabolizer of CYP2D6 was excluded from summary of dextromethorphan parameters. Inje cocktail components were each measured using HPLC with MS/MS detection. CLT/F was measured as liters/hour (L/h)|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|||L/h||Geometric Coefficient of Variation|Geometric Mean
665794|NCT01766050|Secondary|Plasma Half-Life (T-HALF) of the Inje Cocktail Components (Midazolam, Losartan, Omeprazole, Dextromethorphan, and Caffeine) With and Without Coadministration of Belatacept - PK Evaluable Population|Samples for assessment of plasma concentrations of Inje cocktail components (midazolam, losartan, omeprazole, dextromethorphan and caffeine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. The poor metabolizer of CYP2D6 was excluded from summary of dextromethorphan parameters. Inje cocktail components were each measured using HPLC with MS/MS detection. T-HALF was measured in hours (h).|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).||h||Standard Deviation|Mean
665819|NCT01766024|Secondary|Cl of Interferon Beta-1a Blood Samples Were Taken Before the Injection, Then After 15 Min, 30 Min, 45 Min, 1 Hour, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours and 48 Hours.|Secondary outcome measure for pharmacokinetics analysis|0 to 48 hours post-dose||||||
665795|NCT01766050|Secondary|Time of Maximum Observed Plasma Concentration (Tmax) of the Inje Cocktail Components (Midazolam, Losartan, Omeprazole, Dextromethorphan, and Caffeine) With and Without Coadministration of Belatacept - PK Evaluable Population|Samples for assessment of plasma concentrations of Inje cocktail components (midazolam, losartan, omeprazole, dextromethorphan and caffeine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. The poor metabolizer of CYP2D6 was excluded from summary of dextromethorphan parameters. Inje cocktail components were each measured using HPLC with MS/MS detection. Tmax was measured in hours (h).|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|||h||Full Range|Median
665796|NCT01766050|Primary|Adjusted Geometric Mean Maximum Drug Concentration (Cmax) of Midazolam With and Without the Coadministration of Belatacept - Pharmacokinetic (PK) Evaluable Population|Samples for the assessment of plasma concentrations of Inje cocktail components (midazolam, losartan, omeprazole, dextromethorphan and caffeine) and their metabolites (1'-hydroxy-midazolam, E-3174, 5-hydroxyomeprazole, dextrorphan, and paraxanthine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Adjusted geometric mean for midazolam with and without belatacept, along with adjusted geometric mean ratios for Days 4, 7, and 11 versus Day 1, respectively, are presented. Cmax measured in nanograms per milliliter (ng/mL). Inje cocktail components (Midazolam) measured using High Performance Liquid Chromatography (HPLC) with Tandem Mass Spectrometry (MS/MS) Detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Participants who received any study drug and had at least 1 adequate Pharmacokinetic (PK) profile for any Inje cocktail analytes (parent or metabolite).||ng/mL||90% Confidence Interval|Geometric Mean
665797|NCT01766037|Other Pre-specified|Safety Outcomes|The incidence of procedure-related, device-related, and therapy-related serious adverse events. Also, the development of adverse eating behaviors will be assessed.|52 weeks|Modified Intent To Treat (mITT) population of all enrolled subjects||Percent of Subjects|||Number
665798|NCT01766037|Secondary|Change in Number of Subjects on Diabetes Medication|Percent change in the number of subjects on Diabetes medication|52 weeks|Subjects being treated for Type II Diabetes||% Change in Subjects on Medication|||Number
665799|NCT01766037|Secondary|Change in Number of Subjects on Dyslipidemia Medications|Percent change in the number of subjects on Dyslipidemia medications|52 weeks|Subjects being treated for high cholesterol||% Change in Subjects on Medication|||Number
665800|NCT01766037|Secondary|Change in Number of Subjects on Hypertension Medication|Percent change in the number of subjects on Hypertension medication|52 weeks|Subjects being treated for hypertension||% Change in Subjects on Medication|||Number
665801|NCT01766037|Secondary|Change in Medications for Type 2 Diabetes|Percent change in the number of medications taken by subjects for Type 2 Diabetes|52 weeks|Subjects being treated for Type 2 Diabetes||Percent Change in Medications|||Number
665802|NCT01766037|Secondary|Change in Medications for Dyslipidemia|Percent change in the number of medications taken by subjects for dyslipidemia|52 weeks|Subjects being treated for high cholesterol||Percent Change in Medications|||Number
665803|NCT01766037|Secondary|Change in Medication for Hypertension|Percent change in the number of medications taken by subjects for hypertension|52 weeks|Subjects being treated with medications for hypertension||Percent Change in Medications|||Number
665804|NCT01766037|Secondary|Procedural Success|vii) percent procedural success (defined as successful endoscopic placement of the A-Tube) in all subjects undergoing endoscopy|52 weeks|All A-Tube placement attempts||Percent Procedural Success|||Number
665805|NCT01766037|Secondary|Mean Change in Hemoglobin A1C|vi) change in mean hemoglobin A1C (only subjects with T2 diabetes at baseline). Hemoglobin A1C is measured as DCCT%. The change in mean DCCT% from Baseline to Week 52 is reported for this secondary endpoint.|52 weeks|Subjects with Type 2 Diabetes||DCCT% change||95% Confidence Interval|Mean
665806|NCT01766037|Secondary|Mean Change in Score for IWQOL Questionnaire|"v) Impact of Weight on Quality of Life (IWQOL) questionnaire total score
Total score ranges from a minimum of 0 to a maximum of 100. Based on the algorithm developed by Crosby, et.al., patients’ IWQOLLite total scores are considered to have shown meaningful improvement from baseline to one year if they increased between 7 and 12 points, depending upon baseline severity in comparison to the normative mean. Normative means for the IWQOL-Lite have been derived from a sample of 534 non-obese individuals who were not enrolled in any weight loss treatment program [238 women and 296 men with BMI’s between 18.5 and 29.9]. The data presented is the mean change in total score. The AT group demonstrated a mean improvement (increase) in score of 16.3 points, the Control group a mean improvement (increase) of 11.7 points."|52 weeks|Subjects who completed the Questionnaire at 52 weeks||score on a scale||95% Confidence Interval|Mean
665807|NCT01766037|Secondary|Mean Percent Change in Blood Pressure|iv) mean percent change in systolic and diastolic blood pressures in the AT group compared to the control group|52 weeks|Subjects who completed 52 weeks||Percent Change||95% Confidence Interval|Mean
665808|NCT01766037|Secondary|Mean Percent Change in Serum Lipids|iii) mean percent change serum lipids (triglyceride, HDL-cholesterol and LDL-cholesterol concentration) in the AT group compared to the control group|52 weeks|Subjects who completed 52 weeks||Percent Change||95% Confidence Interval|Mean
665809|NCT01766037|Secondary|Percent of Subjects With ≥10% Total Body Weight Loss|ii) proportion of subjects who achieve ≥10% absolute weight loss in AT compared to Control group|52 weeks|Modified Intent To Treat (mITT) population of all enrolled subjects||Percent of Subjects||95% Confidence Interval|Number
665810|NCT01766037|Secondary|Mean Percent Total Body Weight Loss|i) Mean percent absolute weight loss in AT compared to Control group|52 weeks|Modified Intent To Treat (mITT) population of all enrolled subjects||Percent Total Weight Loss||Standard Deviation|Mean
665811|NCT01766037|Primary|% of Subjects Who Achieve >25% EWL|The second co-primary effectiveness endpoint is that at least 50% of the AT group at 52-weeks achieve > 25% EWL.|52 weeks|Modified Intent To Treat (mITT) population of all enrolled subjects||Percent of Subjects||95% Confidence Interval|Number
665820|NCT01766024|Secondary|Кel of Interferon Beta-1a Blood Samples Were Taken Before the Injection, Then After 15 Min, 30 Min, 45 Min, 1 Hour, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours and 48 Hours.|Secondary outcome measure for pharmacokinetics analysis|0 to 48 hours post-dose||||||
666095|NCT01763827|Primary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
665825|NCT01766024|Primary|Area Under Concentration-time Curve (AUC) of Interferon (IFN) Beta-1a From the Moment of Drug Administration Until 48 Hours and to Infinity(AUC(0-48) and AUC(0-∞) Respectively)|Primary outcome measure for pharmacokinetics analysis. Blood samples were taken before the injection, then after 15 min, 30 min, 45 min, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours and 48 hours.|0 to 48 hours post-dose|||(pg/ml)•h||Inter-Quartile Range|Median
665826|NCT01765972|Primary|Percentage Change From Baseline of Corneal Swelling 8 Hours Post Fit|Central corneal thickness was measured at baseline and 8-hour post fit with a modified optical pachometer on a Zeiss biomicroscope, interfaced to a PC. The pachometry measurement included seven readings; the computer is programmed to remove the high and low readings and to calculate the average of the remaining five readings. Only a single central corneal thickness measurement, the average of the 5 readings, was recorded by the investigator in the eCRF. The average percent change from baseline of corneal swelling was reported and was calculated as: ((Post fit - Baseline)/ Baseline) X 100.|8 hours post fit|Analysis population consists of subjects that completed all study visits without a major protocol deviation.||percentage of change from baseline||Standard Deviation|Mean
665827|NCT01765803|Secondary|Toxicity|"Toxicity will be evaluated according to the grading system (0-5) NCI CTCAE (Common Terminology Criteria for Adverse Events) version 4.
Any subject who receives treatment on this protocol will be evaluable for toxicity."|Up to 1 month after treatment|||participants|||Number
665828|NCT01765803|Primary|CD34+ Progenitor Cell Mobilization|To measure CD34+ cells, a peripheral blood draw is taken from the enrolled subject at hour zero on day one of the study before treatment with oral thioridazine. Following treatment, blood draws are taken at 2, 4, 8 and 24 hours. These blood samples are analyzed using Clinical Laboratory Improvement Amendments (CLIA)-approved flow cytometry for CD34+ cell content. CD34+ cell levels will be reported as a percentage of total white blood cells (WBC) in the blood specimens and the difference between baseline and 8 hours will be reported|8 hours following treatment|||percentage of total WBC count||Standard Deviation|Mean
665829|NCT01765764|Secondary|Percentage of Participants With ‘Very Satisfied’ or ‘Mostly Satisfied’ in Eyebrow Satisfaction Scale (ESS) Item #6|"ESS Item #6 measured the participant's satisfaction with eyebrow treatment: Overall, how satisfied are you with the way the eyebrow treatment makes your eyebrows look right now? using a 5-point scale where: 1=very satisfied, 2=mostly satisfied, 3=neither dissatisfied nor satisfied, 4=mostly dissatisfied and 5=very dissatisfied. The percentage of participants 'very satisfied' or 'mostly satisfied' is reported."|Month 7|Intent-to-treat population included all randomized participants.||percentage of participants|||Number
665830|NCT01765764|Secondary|Change From Baseline in Eyebrow Darkness as Measured Using DMSIA|Photographs were taken of the eyebrows. Eyebrow darkness (intensity) was measured by DMSIA for both eyes and averaged. Eyebrow darkness was reported in intensity units. A negative change from Baseline indicated darker eyebrows (improvement).|Baseline, Month 7|Participants from the Intent-to-treat population, all randomized participants, with data available for analysis.||intensity units||Standard Deviation|Mean
665831|NCT01765764|Secondary|Change From Baseline in Eyebrow Fullness as Measured Using Digital Monitoring System Image Analysis (DMSIA)|Photographs were taken of the eyebrows. Eyebrow fullness was measured by DMSIA for both eyes and averaged. Eyebrow fullness was reported in millimeters squared (mm^2). A positive change from Baseline indicated fuller eyebrows (improvement).|Baseline, Month 7|Participants from the Intent-to-treat population, all randomized participants, with data available for analysis.||mm^2||Standard Deviation|Mean
665832|NCT01765764|Primary|Percentage of Participants With at Least a 1-Grade Increase (Improvement) in the 4-Point Global Eyebrow Assessment (GEBA) Scale|The physician evaluated eyebrow fullness using the 4-point GEBA Scale where: 1=very sparse, 2=sparse, 3=full and 4=very full. The percentage of participants with at least a 1-grade increase from Baseline is reported.|Baseline, Month 7|Intent-to-treat population included all randomized participants.||percentage of participants|||Number
665833|NCT01765582|Secondary|Percentage of Participants With Adverse Events|An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|Randomization up to approximately 3 years|Safety population was defined as all randomized participants who received at least one partial or complete dose of study medication.||Percentage of participants|||Number
665834|NCT01765582|Secondary|Proportion of Participants Considered by the Investigator to be Unresectable on Study Enrollment Who Subsequently Underwent Attempted Curative Resections of Metastases|The proportion of participants considered by the investigator to be unresectable at study enrollment who subsequently underwent attempted curative resections of metastases was calculated as follows: number of participants considered by the investigator to be unresectable at study enrollment who subsequently underwent attempted curative resections of metastases divided by total number of participants in each arm. This outcome represents a measure of the rate of conversion from unresectable to resectable disease.|Randomization up to approximately 3 years|ITT population was defined as all randomized participants regardless of whether they received any dose of study treatment.||Proportion of participants||90% Confidence Interval|Number
665835|NCT01765582|Secondary|Proportion of Participants Who Underwent Liver Metastases Resections|Reported here is the proportion of participants who underwent liver metastases resections calculated as follows: number of participants who underwent liver metastases resections divided by total number of participants in each arm.|Randomization up to approximately 3 years|ITT population was defined as all randomized participants regardless of whether they received any dose of study treatment.||Proportion of participants||90% Confidence Interval|Number
665836|NCT01765582|Secondary|Overall Survival (OS)|OS was defined as the time from the date of randomization to the date of death from any cause.|Randomization until death due to any cause (up to approximately 3 years)|ITT population was defined as all randomized participants regardless of whether they received any dose of study treatment.||months||90% Confidence Interval|Median
665936|NCT01765153|Secondary|Change in 6 Minute Walk Test (6MWT) at 2 Months of Training Phase II|Participants walk for as far as possible in 6 min along a 25m hallway. Total distance walked in the time is measured. Results are calculated as : Distance walked at end of period - Distance walked at beginning of period.|Change from Baseline II to 2 months of Training Phase II|||metres||Standard Deviation|Mean
665837|NCT01765582|Secondary|Time to PFS2|Time to PFS2 was defined as time from randomization to the first occurrence of disease progression after reinduction of second-line therapy, as assessed by the Investigator using RECIST v1.1, or death from any cause, whichever occurs first. Disease progression was defined as sum of longest diameters increased by at least 20% from the smallest value on study. The sum of longest diameters must also demonstrate an absolute increase of at least 5mm.|Randomization up to disease progression during second-line therapy or death, whichever occurs first (up to approximately 3 years)|ITT population was defined as all randomized participants regardless of whether they received any dose of study treatment.||months||90% Confidence Interval|Median
665838|NCT01765582|Primary|Progression-Free Survival During First-Line Therapy (PFS1)|PFS1 was defined as time from randomization to the first occurrence of disease progression during first-line therapy, as assessed by the Investigator using RECIST v1.1, or death from any cause, whichever occurs first. Disease progression was defined as sum of longest diameters increased by at least 20% from the smallest value on study. The sum of longest diameters must also demonstrate an absolute increase of at least 5 mm.|Randomization up to disease progression during first-line therapy or death, whichever occurs first (up to approximately 3 years)|ITT population was defined as all randomized participants regardless of whether they received any dose of study treatment.||months||90% Confidence Interval|Median
665839|NCT01765582|Primary|Percentage of Participants With Overall Response During First-Line Therapy (ORR1)|ORR1 was the percentage of participants with complete response (CR) or partial response (PR) during first-line therapy as assessed by investigator according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v.1.1). CR was defined as disappearance of all extranodal target lesions and all pathological lymph nodes had to have decreased to <10 millimeter (mm) in short axis. PR was defined as at least a 30% decrease in the sum of longest diameters of target lesions, taking as reference the baseline sum diameters. ORR1 = CR + PR|Randomization up to disease progression during first-line therapy or death, whichever occurs first (up to approximately 3 years)|ITT population was defined as all randomized participants regardless of whether they received any dose of study treatment.||Percentage of participants|||Number
665840|NCT01765569|Primary|Apparent Clearance (CL/F) of Digoxin|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Hour [H] 0, 0.5, 1, 2, 3, 4, 6, 8, 10−12 (Day [D] 1), 24, 30-32 (D2), 48 (D3), 72 (D4), 96 (D5), 168 (D8) post-digoxin dose; H0, 0.5, 1, 2, 3, 4, 6, 8, and 10−12H (D29), 24, 30-32 (D30), 48 (D31), 72 (D32), 96 (D33), 168 (D36) post digoxin dose|PK Population. Number of participants analysed = participants evaluable for the analysis.||liters/hour||Standard Deviation|Mean
665841|NCT01765569|Primary|Terminal Half-Life (t1/2) of Digoxin||Hour [H] 0, 0.5, 1, 2, 3, 4, 6, 8, 10−12 (Day [D] 1), 24, 30-32 (D2), 48 (D3), 72 (D4), 96 (D5), 168 (D8) post-digoxin dose; H0, 0.5, 1, 2, 3, 4, 6, 8, and 10−12H (D29), 24, 30-32 (D30), 48 (D31), 72 (D32), 96 (D33), 168 (D36) post digoxin dose|PK Population. Number of participants analysed = participants evaluable for the analysis.||hours||Standard Deviation|Mean
665842|NCT01765569|Primary|Time to Maximum Plasma Concentration (Tmax) of Digoxin||Hour [H] 0, 0.5, 1, 2, 3, 4, 6, 8, 10−12 (Day [D] 1), 24, 30-32 (D2), 48 (D3), 72 (D4), 96 (D5), 168 (D8) post-digoxin dose; H0, 0.5, 1, 2, 3, 4, 6, 8, and 10−12H (D29), 24, 30-32 (D30), 48 (D31), 72 (D32), 96 (D33), 168 (D36) post digoxin dose|PK Population.||hours||Full Range|Median
665843|NCT01765569|Primary|Maximum Plasma Concentration (Cmax) of Digoxin||Hour [H] 0, 0.5, 1, 2, 3, 4, 6, 8, 10−12 (Day [D] 1), 24, 30-32 (D2), 48 (D3), 72 (D4), 96 (D5), 168 (D8) post-digoxin dose; H0, 0.5, 1, 2, 3, 4, 6, 8, and 10−12H (D29), 24, 30-32 (D30), 48 (D31), 72 (D32), 96 (D33), 168 (D36) post digoxin dose|PK Population.||ng/mL||Standard Deviation|Mean
665844|NCT01765569|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to 168 Hours (AUC168) of Digoxin||Hour [H] 0, 0.5, 1, 2, 3, 4, 6, 8, 10−12 (Day [D] 1), 24, 30-32 (D2), 48 (D3), 72 (D4), 96 (D5), 168 (D8) post-digoxin dose; H0, 0.5, 1, 2, 3, 4, 6, 8, and 10−12H (D29), 24, 30-32 (D30), 48 (D31), 72 (D32), 96 (D33), 168 (D36) post digoxin dose|PK Population.||hour*ng/mL||Standard Deviation|Mean
665845|NCT01765569|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC24) of Digoxin||Hour [H] 0, 0.5, 1, 2, 3, 4, 6, 8, 10−12 (Day [D] 1), 24, 30-32 (D2), 48 (D3), 72 (D4), 96 (D5), 168 (D8) post-digoxin dose; H0, 0.5, 1, 2, 3, 4, 6, 8, and 10−12H (D29), 24, 30-32 (D30), 48 (D31), 72 (D32), 96 (D33), 168 (D36) post digoxin dose|PK Population.||hour*ng/mL||Standard Deviation|Mean
665846|NCT01765569|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUCinf) of Digoxin||Hour [H] 0, 0.5, 1, 2, 3, 4, 6, 8, 10−12 (Day [D] 1), 24, 30-32 (D2), 48 (D3), 72 (D4), 96 (D5), 168 (D8) post-digoxin dose; H0, 0.5, 1, 2, 3, 4, 6, 8, and 10−12H (D29), 24, 30-32 (D30), 48 (D31), 72 (D32), 96 (D33), 168 (D36) post digoxin dose|PK Population. Number of participants analysed = participants evaluable for the analysis.||hour*ng/mL||Standard Deviation|Mean
665847|NCT01765569|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUClast) of Digoxin|AUClast = Area under the plasma-concentration time curve from time zero to the last measurable plasma concentration which is presented in hour*nanogram per milliliter (hour*ng/mL). Hour 0 (H0) signified pre-dose sampling.|Hour [H] 0, 0.5, 1, 2, 3, 4, 6, 8, 10−12 (Day [D] 1), 24, 30-32 (D2), 48 (D3), 72 (D4), 96 (D5), 168 (D8) post-digoxin dose; H0, 0.5, 1, 2, 3, 4, 6, 8, and 10−12H (D29), 24, 30-32 (D30), 48 (D31), 72 (D32), 96 (D33), 168 (D36) post digoxin dose|PK Population included participants for whom PK data were collected.||hour*ng/mL||Standard Deviation|Mean
665848|NCT01765543|Other Pre-specified|Percent Extrapolated AUC(0-inf) (AUCpeo) of Vemurafenib|The AUCpeo, that is, percent area obtained after extrapolation from Tlast to infinity is calculated by using the formula AUCpeo = 100*(AUC[0-inf] minus AUC[0-last])/AUC(0-inf). This parameter provides information about what percentage of the theoretical curve AUC(0-inf) is possible to determine experimentally (AUC0-last).|Predose (0 hour), 1, 2, 4, 6, 8, 12, 24, 30-32, 48, 72, 96, 120, 168 hours post vemurafenib-dose on Day 1 (Period A) and Day 17 (Period C)|PK parameter population||percent AUC||Geometric Coefficient of Variation|Geometric Mean
665961|NCT01764841|Secondary|Number of Participants With Exacerbation Events With Worsening of at Least One Sign/Symptom Over 48 Weeks|For this outcome measure, exacerbation events were defined as exacerbations with systemic antibiotic use and worsening of at least one sign/symptom over 48 weeks.|Up to Week 48|Full analysis set (FAS) included participants who were randomized.||Participants|||Count of Participants
665849|NCT01765543|Other Pre-specified|Area Under the Plasma Concentration Time-curve From Zero to 168 Hours [AUC(0-168)] of Vemurafenib|AUC(0-168) is the AUC from time zero (pre-dose) to 168 hours (time point for last blood sample collection). AUC is a measure of the plasma concentration of a drug over time. AUC(0-168) is presented in mcg*h/mL.|Predose (0 hour), 1, 2, 4, 6, 8, 12, 24, 30-32, 48, 72, 96, 120, 168 hours post vemurafenib-dose on Day 1 (Period A) and Day 17 (Period C)|PK parameter population||mcg*h/mL||Geometric Coefficient of Variation|Geometric Mean
665850|NCT01765543|Other Pre-specified|Plasma Apparent Clearance (CL/F) of Vemurafenib|Clearance of a drug is a measure of the rate at which a drug is removed (metabolized or eliminated by normal biological processes) from the blood. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.|Predose (0 hour), 1, 2, 4, 6, 8, 12, 24, 30-32, 48, 72, 96, 120, 168 hours post vemurafenib-dose on Day 1 (Period A) and Day 17 (Period C)|PK parameter population||liters/hour||Geometric Coefficient of Variation|Geometric Mean
665851|NCT01765543|Other Pre-specified|Plasma Elimination Half Life (t1/2) of Vemurafenib|Plasma elimination half-life is the time measured during drug elimination phase for the plasma drug concentration to decrease by one half.|Predose (0 hour), 1, 2, 4, 6, 8, 12, 24, 30-32, 48, 72, 96, 120, 168 hours post vemurafenib-dose on Day 1 (Period A) and Day 17 (Period C)|PK parameter population||hours||Standard Deviation|Mean
665852|NCT01765543|Other Pre-specified|Time to Reach Cmax (Tmax) of Vemurafenib|Tmax is the time from vemurafenib administration to reach Cmax for vemurafenib.|Predose (0 hour), 1, 2, 4, 6, 8, 12, 24, 30-32, 48, 72, 96, 120, 168 hours post vemurafenib-dose on Day 1 (Period A) and Day 17 (Period C)|PK parameter population||hours||Full Range|Median
665853|NCT01765543|Primary|Maximum Observed Plasma Concentration (Cmax) of Vemurafenib|Cmax is the maximum observed plasma vemurafenib concentration, presented in microgram per milliliter (mcg/mL).|Predose (0 hour), 1, 2, 4, 6, 8, 12, 24, 30-32, 48, 72, 96, 120, 168 hours post vemurafenib-dose on Day 1 (Period A) and Day 17 (Period C)|PK parameter population||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
665854|NCT01765543|Primary|Area Under the Plasma Concentration Time-curve From Zero to Extrapolated Infinite Time (AUC[0-inf]) of Vemurafenib|AUC(0-inf) is the AUC from time zero (pre-dose) to extrapolated infinite time (0-inf). AUC is a measure of the plasma concentration of a drug over time. AUC(0-inf) is presented in mcg*h/mL.|Predose (0 hour), 1, 2, 4, 6, 8, 12, 24, 30-32, 48, 72, 96, 120, 168 hours post vemurafenib-dose on Day 1 (Period A) and Day 17 (Period C)|PK parameter population||mcg*h/mL||Geometric Coefficient of Variation|Geometric Mean
665855|NCT01765543|Primary|Area Under the Plasma Concentration Time-curve From Zero to the Last Measurable Concentration Time Point (AUClast) of Vemurafenib|AUClast is the area under the vemurafenib plasma concentration versus time curve from time zero to the time of last measured concentration of vemurafenib (Tlast). Area under the curve (AUC) is a measure of the plasma concentration of a drug over time. AUClast is presented in micrograms times (*) hour per milliliter (mcg*h/mL).|Predose (0 hour), 1, 2, 4, 6, 8, 12, 24, 30-32, 48, 72, 96, 120, 168 hours post vemurafenib-dose on Day 1 (Period A) and Day 17 (Period C)|The pharmacokinetics (PK) parameter population included all participants who received both scheduled doses of vemurafenib and who provided adequate PK assessments to calculate important PK parameters.||mcg*h/mL||Geometric Coefficient of Variation|Geometric Mean
665862|NCT01765465|Secondary|Laboratory Test Results of Postoperative 3-month(WBC Count)|"laboratory test results(WBC count) measured at postoperative 3-month of Rowachol group and placebo group.
each result is mean values."|postoperative 3-month|||cells (10^6/µl)||Standard Deviation|Mean
665863|NCT01765465|Secondary|Laboratory Test Results of Postoperative 3-month(Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase)|"laboratory test results(liver function test such as Alkaline phosphatase, Aspartate aminotransferase, Alanine aminotransferase) measured at postoperative 3-month of Rowachol group and placebo group.
each result is mean values."|postoperative 3-month|||IU/dL||Standard Deviation|Mean
665864|NCT01765465|Secondary|Laboratory Test Results of Postoperative 3-month(Total Bilirubin, Direct Bilirubin)|"laboratory test results(liver function test such as total bilirubin, direct bilirubin) measured at postoperative 3-month of Rowachol group and placebo group.
each result is mean values."|postoperative 3-month|||mg/dL||Standard Deviation|Mean
665865|NCT01765465|Primary|the Number of the Participants Have Postoperative RUQ Pain|"Right upper quadrant(RUQ) pain by European Organization for Research and Treatment of Cancer(EORTC) quality of life questionnaire(QLQ) C-30 No. 9, 19 at baseline and postoperative 3-month.
The pain score of individuals at postoperative 3-month is calculated by EORTC QLQ C-30 manual.
The pain score range is 0 to 100. Higher score means participants feel more pain(worse). If a participant's pain score is over 30, we define he/she has post operative RUQ pain. we use the number of the participants have post operative RUQ pain(score over 30) as the results."|postoperative 3-month|||number of participants|||Number
666027|NCT01763918|Secondary|Change From Baseline in LDL-C at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||mg/dL||Standard Error|Least Squares Mean
665866|NCT01765426|Primary|Percentage of Participants With Unsolicited Vaccine-Related SAEs|A serious adverse event (SAE) is any AE in the view of the investigator that results in any of the following outcomes: death, life threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that may require medical or surgical intervention to prevent one of the other serious outcomes.|Dose 1 until 28 days after Dose 2 (Up to Day 118)|Safety analysis set included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose.||percentage of participants|||Number
665867|NCT01765426|Secondary|Percentage of Participants With Serotype-Specific DENVax RNA Detected Due to Each of the Four Dengue Vaccine Components After Each Vaccination|A quantitative reverse transcriptase-polymerase chain reaction (qRT-PCR) assay was used for detection and serotype identification of dengue viral ribonucleic acid (RNA) that is present in serum. A test for viremia is considered positive if the assay value is >= 3.6, which is the limit of quantification (LOQ), negative if the assay value was zero, and undetermined if the assay value is >0 but <3.6. The percentage of participants with positive results is reported.|Day 0 to Day 104|Full analysis set included all randomized participants who received at least one dose of study vaccine and for whom valid pre-dosing and at least one valid sample for immunogenicity (eg, seroconversion) was received.||percentage of participants|||Number
665868|NCT01765426|Secondary|Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes at Days 90 and 270|Seroconversion rate is defined as the percentage of participants with PRNT50 titer ≥ 10 or, if the titer on Day 0 is greater than 10, a four-fold rise in antibody titer.|Days 90 and 270|Per Protocol Set included all randomized participants who completed the study without any major protocol violations.||percentage of participants||95% Confidence Interval|Number
665869|NCT01765426|Secondary|Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes||Days 0, 28, 90, 118 and 270|Per Protocol Set included all randomized participants who completed the study without any major protocol violations.||titer||95% Confidence Interval|Geometric Mean
665870|NCT01765426|Primary|Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After Second Injection|Seroconversion rate is defined as the percentage of participants with PRNT50 titer ≥ 10 or, if the titer on Day 0 is greater than 10, a four-fold rise in antibody titer.|Day 118|Per Protocol Set included all randomized participants who completed the study without any major protocol violations.||percentage of participants||95% Confidence Interval|Number
665871|NCT01765426|Primary|Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After First Injection|Seroconversion rate is defined as the percentage of participants with PRNT50 titer ≥ 10 or, if the titer on Day 0 is greater than 10, a four-fold rise in antibody titer.|Day 28|Per Protocol Set included all randomized participants who completed the study without any major protocol violations.||percentage of participants||95% Confidence Interval|Number
665872|NCT01765426|Primary|Percentage of Participants With Abnormal Laboratory Values Reported as Adverse Events (AEs)|"The percentage of participants with any clinically relevant abnormal safety laboratory values (chemistry, hematology and urinalysis) collected from vaccine dose 1 (Day 0) through 28 days after dose 2 (Day 90) that were reported as AEs.
Abnormal laboratory values were reported as AEs based on the following criteria: Grade 3 (Severe) or Grade 4 (Life threatening) laboratory abnormalities based on DMID toxicity tables or laboratory abnormalities which resulted in a medical intervention."|118 Days|Safety analysis set included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose.||percentage of participants|||Number
665873|NCT01765426|Primary|Percentage of Participants With Unsolicited Vaccine-Related AEs Within 28 Days After Either Vaccine Dose by Maximum Severity|An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. AEs are graded from Grade 0=None to Grade 4=Life threatening. AEs are presented as the percentage of participants experiencing an AE causally related to the study treatment as assessed by the investigator, overall and by severity, using the participant’s worst reported severity grade. Only categories for which there was at least 1 participant are reported.|28 Days after each dose|Safety analysis set included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose.||percentage of participants|||Number
665874|NCT01765426|Primary|Percentage of Participants With Solicited Local AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity|An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Local injection site AEs solicited from the participant using a memory aid included: erythema (redness), edema/induration (swelling), pain and pruritus (itching). Local injection site reactions are presented as the percentage of participants experiencing a reaction, by reaction type, overall and by severity, using the participant’s worst reported severity grade.|14 days after each dose|Safety analysis set included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose.||percentage of participants|||Number
665875|NCT01765426|Primary|Percentage of Participants With Solicited Systemic AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity|An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Systemic AEs solicited from the participant using a memory aid included: body temperature, headache, myalgia (muscle pain), arthralgia (joint pain), photophobia (sensitivity to light), fatigue (tiredness), body rash, nausea and vomiting. Systemic AEs were graded using the scale: Grade 0= none to Grade 4=Life threatening. Systemic reactions are presented as percentage of participants experiencing a reaction, by reaction type, overall and by severity, using the participant’s worst reported severity grade. Only categories for which there was at least 1 participant are reported.|14 days after each dose|Safety analysis set included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose.||percentage of participants|||Number
666028|NCT01763918|Primary|Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
666089|NCT01763827|Secondary|Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
665876|NCT01765426|Primary|Percentage of Participants With Unsolicited Adverse Events (AE) by Maximum Severity|An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. AEs are graded from Grade 0=None to Grade 4=Life threatening. AEs are presented as the percentage of participants experiencing an AE, overall and by severity, using the participant’s worst reported severity grade.|28 Days after each dose|Safety analysis set included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose.||percentage of participants|||Number
665877|NCT01765426|Primary|Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff|An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Local injection site reactions were evaluated by the blinded clinical staff and include: erythema (redness), edema/induration (swelling), pain and pruritus (itching). Severity grades for erythema and edema are derived based on the Division of Microbiology and Infectious Diseases (DMID) toxicity grading longest diameters using the scale 0=none, 1=<15 millimeters (mm), 2=15 to 30 mm and 3=>30 mm (severe). Pain and itching were graded using the scale: 0=none to 4=requires ER visit or hospitalization. Local injection site reactions are presented as the percentage of participants experiencing a reaction, by reaction type, overall and by severity, using the participant’s worst reported severity grade. Only categories for which there was at least 1 participant are reported.|28 Days after each dose|Safety analysis set included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose.||percentage of participants|||Number
665878|NCT01765270|Secondary|Need for Antiarrhythmic Therapy||CABG surg to hospital discharge Approximately 5 days|||participants|||Number
665879|NCT01765270|Secondary|Number of Participants Who Required Intraaortic Balloon Pump (IABP) Support||CABG to hospital discharge (Approximately 5 days)|||participants|||Number
665880|NCT01765270|Secondary|Number of Participants Who Had an Episode of Hypoglycemia||baseline to end of study (Approximately 35-37 days)|||participants|||Number
665881|NCT01765270|Secondary|Duration of Inotropic Support||CABG surg until hosp discharge (Approximately 5 days)|||hours||Standard Deviation|Mean
665882|NCT01765270|Secondary|Number of Major Adverse Cardiac Events (MACE)|Death, myocardial infarction (MI), or New congestive heart failure (CHF)|Baseline to end of study (Approximately 35-37 days)|||Cardiac Events|||Number
665883|NCT01765270|Secondary|Creatine Kinase-Myocardial Bands (CK-MB) Area Under the Curve||pre-CABG surgery (after 5 to 7 days of assigned treatment, predischarge or 5 days post-CABG surgery (Approximately 12 days)|||ng*hr/mL||Inter-Quartile Range|Median
665884|NCT01765270|Secondary|High Sensitive Troponin-I (hsTnT) Area Under the Curve||pre-CABG surgery (after 5 to 7 days of assigned treatment, predischarge or 5 days post-CABG surgery (Approximately 12 days)|||ng*hr/mL||Inter-Quartile Range|Median
665885|NCT01765270|Primary|Troponin I (TnI) Area Under the Curve (AUC)||pre-CABG surgery (after 5 to 7 days of assigned treatment, predischarge or 5 days post-CABG surgery (Approximately 12 days)|||ng*hr/mL||Inter-Quartile Range|Median
665886|NCT01765192|Secondary|Change From Baseline in Nighttime Asthma Symptoms|Patients will assess their daily night-time asthma symptoms according to the following scale: 0: No symptoms, slept through the night. 1: Slept well but some complaints in the morning. 2: Woke up once because of asthma (inclusive early awakening). 3: Woke up several times because of asthma (inclusive early awakening). 4: Bad night, awake most of the night because of asthma. An ANCOVA model with treatment sequence, treatment period, and study treatment as fixed factors with Baseline Nighttime Asthma Symptoms measurement as the covariate was used for analysis. A negative change from Baseline indicates improvement.|Baseline (Days 1 and 56) and after 4 weeks of treatment (Days 28 and 84)|Full analysis set: All randomized participants, analyzed according to the randomized treatment with data available for analysis after 4 weeks of treatment.||units on a scale||Standard Error|Least Squares Mean
665887|NCT01765192|Secondary|Change From Baseline in Daytime Asthma Symptoms|Patients will assess their daily day-time asthma symptoms according to the following scale: 0: Very well, no symptoms. 1: One episode of wheezing, cough or breathlessness. 2: More than one episode of wheezing, cough or breathlessness without interfering with normal activities. 3: Wheezing, cough or short of breath most of the day which interfered to some extent with normal activities. 4: Asthma very bad. Unable to carry out daily activities as usual. An ANCOVA model with treatment sequence, treatment period, and study treatment as fixed factors with Baseline Daytime Asthma Symptoms measurement as the covariate was used for analysis. A negative change from Baseline indicates improvement.|Baseline (Days 1 and 56) and after 4 weeks of treatment (Days 28 and 84)|Full analysis set: All randomized participants, analyzed according to the randomized treatment with data available for analysis after 4 weeks of treatment.||units on a scale||Standard Error|Least Squares Mean
665888|NCT01765192|Secondary|Change From Baseline in Morning Peak Expiratory Flow (PEF)|PEF will be measured at home using portable electronic peak flow meter. The participant will record PEF daily in the morning immediately after getting up. An ANCOVA model with treatment sequence, treatment period, and study treatment as fixed factors with Baseline PEF measurement as the covariate was used for analysis.|Baseline (Days 1 and 56) and after 4 weeks of treatment (Days 28 and 84)|Full analysis set: All randomized participants, analyzed according to the randomized treatment with PEF data available for analysis after 4 weeks of treatment.||L/min||Standard Error|Least Squares Mean
665889|NCT01765192|Secondary|Change From Baseline in Pre-Dose (Trough) Pre-Bronchodilator Peak Expiratory Flow (PEF)|PEF is a person's maximum speed of expiration. It measures the airflow through the bronchi and thus the degree of obstruction in the airways. PEF will be measured using spirometry in accordance with ATS/ERS consensus guidelines. An ANCOVA model with treatment sequence, treatment period, and study treatment as fixed factors with Baseline PEF measurement as the covariate was used for analysis.|Baseline (Days 1 and 56) and after 4 weeks of treatment (Days 28 and 84)|Full analysis set: All randomized participants, analyzed according to the randomized treatment with PEF data available for analysis after 4 weeks of treatment.||liters/minute (L/min)||Standard Error|Least Squares Mean
666029|NCT01763918|Primary|Percent Change From Baseline in LDL-C at Week 12||Baseline and Week 12|Full analysis set. Least squares (LS) means are from a repeated measures linear effects model; missing values were not imputed.||percent change||Standard Error|Least Squares Mean
665890|NCT01765192|Secondary|Change From Baseline in Pre-Dose (Trough) Pre-Bronchodilator Forced Expiratory Flow (FEF) 25-75%|FEF is a measure of how much air can be exhaled from the lungs. It is an indicator of obstruction of the smaller airways. FEF25-75% is the mid-flow rate or forced expiratory flow occurring in the middle 50% of the patient's exhaled volume, and will be measured using spirometry in accordance with ATS/ERS consensus guidelines. An ANCOVA model with treatment sequence, treatment period, and study treatment as fixed factors with Baseline FEF measurement as the covariate was used for analysis.|Baseline (Days 1 and 56) and after 4 weeks of treatment (Days 28 and 84)|Full analysis set: All randomized participants, analyzed according to the randomized treatment with FEF data available for analysis after 4 weeks of treatment.||liters/second||Standard Error|Least Squares Mean
665891|NCT01765192|Secondary|Change From Baseline in Pre-Dose (Trough) Pre-Bronchodilator Forced Vital Capacity (FVC)|FVC is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC will be measured using spirometry in accordance with ATS/ERS consensus guidelines. An ANCOVA model with treatment sequence, treatment period, and study treatment as fixed factors with Baseline FVC measurement as the covariate was used for analysis.|Baseline (Days 1 and 56) and after 4 weeks of treatment (Days 28 and 84)|Full analysis set: All randomized participants, analyzed according to the randomized treatment with FVC data available for analysis after 4 weeks of treatment.||liters||Standard Error|Least Squares Mean
665892|NCT01765192|Primary|Change From Baseline in Pre-Dose (Trough) Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEV1 will be measured using spirometry in accordance with the American Thoracic Society / European Respiratory Society (ATS/ERS) consensus guidelines. An ANCOVA model with treatment sequence, treatment period, and study treatment as fixed factors with Baseline FEV1 measurement as the covariate was used for analysis.|Baseline (Days 1 and 56) and after 4 weeks of treatment (Days 28 and 84)|Full analysis set: All randomized participants, analyzed according to the randomized treatment with FEV1 data available for analysis after 4 weeks of treatment.||liters||Standard Error|Least Squares Mean
665893|NCT01765179|Secondary|Percentage of Treated Patients With Maximum Serum T Concentrations (Cmax) Values in Selected Ranges on Day 114 Efficacy Population||Following 114 days of treatment|||Participants|||Count of Participants
665894|NCT01765179|Primary|Percentage of Treated Patients With an Average Serum Testosterone (T) Concentration (Cavg) Between 300 and 1000 ng/dL||Following 114 days of treatment|||Participants|||Count of Participants
665895|NCT01765153|Secondary|Change in Electromyography During Treadmill Walking at the End of 2 Months of Rest Period II|Participants walk on a treadmill at a variety of speeds while we record surface electromyography from leg muscles and motion data from electrogoniometers place on the knees.|Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II|Data was analysed for the 13 participants who provided CMR data in Training phase 1. 1 out 13 withdrew and 3 did not produce adequate reflex activity to allow analysis.||µV||Standard Deviation|Mean
665896|NCT01765153|Secondary|Change in Electromyography During Treadmill Walking at 2 Months of Training Phase II|Participants walk on a treadmill at a variety of speeds while we record surface electromyography from leg muscles and motion data from electrogoniometers place on the knees.|Change from Baseline II to 2 months of Training Phase II|Data from 5 participants could not be analysed due to absence of reflex, or difficulty with EMG signals. Remaining 13 were analysed.||µV||Standard Deviation|Mean
665897|NCT01765153|Secondary|Change in Electromyography During Treadmill Walking at the End of 2 Months of Rest Period I|Participants walk on a treadmill at a variety of speeds while we record surface electromyography from leg muscles and motion data from electrogoniometers place on the knees.|Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I|Data was analysed for the 13 participants who provided CMR data in Training phase 1 to determine if training effect was maintained. 1 out 13 withdrew and 1 did not produce adequate reflex activity to allow analysis||µV||Standard Deviation|Mean
665898|NCT01765153|Secondary|Change in Electromyography During Treadmill Walking at 2 Months of Training Phase I|Participants walk on a treadmill at a variety of speeds while we record surface electromyography from leg muscles and motion data from electrogoniometers place on the knees.|Change from Baseline I to 2 months of Training Phase I|Data from 6 participants could not be analysed due to absence of reflex, or difficulty with EMG signals. Remaining 13 were analysed.||µV||Standard Deviation|Mean
665899|NCT01765153|Secondary|Change in Transcranial Magnetic Stimulation (TMS) at the End of 2 Months of Rest Period II|Maximum evoked potentials were measured and compared to baseline measures for major muscle groups.|Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II|||percentage of baseline MEP||Standard Error|Mean
665900|NCT01765153|Secondary|Change in Transcranial Magnetic Stimulation (TMS) at 2 Months of Training Phase II|Single-pulse TMS is applied over the motor cortex, and electromyographic responses are recorded in the tibialis anterior muscles on both legs.|Change from Baseline II to 2 months of Training Phase II|||percentage of baseline mep||Standard Error|Mean
665901|NCT01765153|Secondary|Change in Transcranial Magnetic Stimulation (TMS) at the End of 2 Months of Rest Period I|Single-pulse TMS is applied over the motor cortex, and electromyographic responses are recorded in the tibialis anterior muscles on both legs.|Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I|||percentage of baseline mep||Standard Error|Mean
665902|NCT01765153|Secondary|Change in Transcranial Magnetic Stimulation (TMS) at 2 Months of Training Phase I|Single-pulse TMS is applied over the motor cortex, and electromyographic responses are recorded in the tibialis anterior muscles on both legs.|Change from Baseline I to 2 months of Training Phase I|||Percentage of baseline mep||Standard Error|Mean
665903|NCT01765153|Secondary|Change in Cutaneomuscular Reflexes at the End of 2 Months of Rest Period II|Reflexes are elicited with electrical stimulation (3 pulses) of the tibial nerve at the ankle using surface electrodes. Responses are recorded with surface electromyography (EMG). Responses are typically recorded in standing.|Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II|Data was analysed for the 13 participants who provided CMR data in Training phase 1 to determine whether training effect was maintained. 1 out 13 withdrew and 3 did not produce adequate reflex activity to allow analysis.||µV||Standard Deviation|Mean
666090|NCT01763827|Secondary|Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12||Week 12|Full analysis set||percentage of participants||95% Confidence Interval|Number
665904|NCT01765153|Secondary|Change in Cutaneomuscular Reflexes at 2 Months of Training Phase II|Reflexes are elicited with electrical stimulation (3 pulses) of the tibial nerve at the ankle using surface electrodes. Responses are recorded with surface electromyography (EMG). Responses are typically recorded in standing.|Change from Baseline II to 2 months of Training Phase II|Data from 5 participants could not be analysed due to absence of reflex, or difficulty with EMG signals. Remaining 13 were analysed.||µV||Standard Deviation|Mean
665905|NCT01765153|Secondary|Change in Cutaneomuscular Reflexes at the End of 2 Months of Rest Period I|Reflexes are elicited with electrical stimulation (3 pulses) of the tibial nerve at the ankle using surface electrodes. Responses are recorded with surface electromyography (EMG). Responses are typically recorded in standing.|Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I|Data was analysed for the 13 participants who provided CMR data in Training phase 1 in order to dtermine if training effect was maintained. 1 out 13 withdrew and 1 did not produce adequate reflex activity to allow analysis||µV||Standard Deviation|Mean
665906|NCT01765153|Secondary|Change in Cutaneomuscular Reflexes at 2 Months of Training Phase I|Reflexes are elicited in standing by electrical stimulation (3 pulses) of the tibial nerve at the ankle using surface electrodes. Responses are recorded with surface electromyography (EMG) in µV.|Change from Baseline I to 2 months of Training Phase I|Data from 6 participants could not be analysed due to absence of reflex, or difficulty with EMG signals. Remaining 13 were analysed.||µV||Standard Deviation|Mean
665907|NCT01765153|Secondary|Change in Manual Muscle Test (MMT) at the End of 2 Months of Rest Period II|"The strength of each of 8 major muscle groups (per side) in the lower extremities is graded using the standard manual muscle testing technique. Strength is graded from 0 (no muscle activity detected) to 5 (strength with normal range for the muscle group). Scores from all muscle groups are added to obtain the total score. The total score ranges from 0 (unable to produce any muscle activity in all 8 muscle groups bilaterally) to 80 (normal strength in all 8 muscle groups bilaterally).
Results are reported as Final score - Initial score. A positive result indicates an increase in strength."|Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II|||units on a scale||Standard Deviation|Mean
665908|NCT01765153|Secondary|Change in Manual Muscle Test (MMT) at 2 Months of Training Phase II|The strength of each of 8 major muscle groups (per side) in the lower extremities is graded using the standard manual muscle testing technique. Strength is graded from 0 (no muscle activity detected) to 5 (strength with normal range for the muscle group). Scores from all muscle groups are added to obtain the total score. The total score ranges from 0 (unable to produce any muscle activity in all 8 muscle groups bilaterally) to 80 (normal strength in all 8 muscle groups bilaterally). Results are reported as Final score - Initial score. A positive result indicates an increase in strength.|Change from Baseline II to 2 months of Training Phase II|This measure was accidentally omitted for 1 participant at beginning of this phase. Data analysed for all participants who performed this measure.||units on a scale||Standard Deviation|Mean
665909|NCT01765153|Secondary|Change in Manual Muscle Test (MMT) at the End of 2 Months of Rest Period I|"The strength of each of 8 major muscle groups (per side) in the lower extremities is graded using the standard manual muscle testing technique. Strength is graded from 0 (no muscle activity detected) to 5 (strength with normal range for the muscle group). Scores from all muscle groups are added to obtain the total score. The total score ranges from 0 (unable to produce any muscle activity in all 8 muscle groups bilaterally) to 80 (normal strength in all 8 muscle groups bilaterally).
Results are reported as Final score - Initial score. A positive result indicates an increase in strength."|Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I|This measure was accidentally omitted for 1 participant at the end of this phase. Data analysed for all participants who performed this measure.||units on a scale||Standard Deviation|Mean
665910|NCT01765153|Secondary|Change in Manual Muscle Test (MMT) at 2 Months of Training Phase I|"The strength of each of 8 major muscle groups (per side) in the lower extremities is graded using the standard manual muscle testing technique. Strength is graded from 0 (no muscle activity detected) to 5 (strength with normal range for the muscle group). Scores from all muscle groups are added to obtain the total score. The total score ranges from 0 (unable to produce any muscle activity in all 8 muscle groups bilaterally) to 80 (normal strength in all 8 muscle groups bilaterally).
Results are reported as Final score - Initial score. A positive result indicates an increase in strength."|Change from Baseline I to 2 months of Training Phase I|||units on a scale||Standard Deviation|Mean
665911|NCT01765153|Secondary|Change in Center for Epidemiologic Studies - Depression Scale (CES-D) at the End of 2 Months of Rest Period II|"A 20 question survey to measure current level of depressive symptoms.The participant ranks their emotional state or actions for each question on an ordinal scale of 0 to 3, with 0 indicating rarely or never and 3 being most of the time. A minimum score of 0 indicates no depressive symptoms, and a score of 10 or greater is considered indicative of depression. The max score for the scale is 60.
Results are reported as Final score - Initial score. A negative result indicates a lower level of depression."|Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II|||units on a scale||Standard Deviation|Mean
665912|NCT01765153|Secondary|Change in Center for Epidemiologic Studies - Depression Scale (CES-D) at 2 Months of Training Phase II|"A 20 question survey to measure current level of depressive symptoms.The participant ranks their emotional state or actions for each question on an ordinal scale of 0 to 3, with 0 indicating rarely or never and 3 being most of the time. A minimum score of 0 indicates no depressive symptoms, and a score of 10 or greater is considered indicative of depression. The max score for the scale is 60.
Results are reported as Final score - Initial score. A negative result indicates a lower level of depression."|Change from Baseline II to 2 months of Training Phase II|||units on a scale||Standard Deviation|Mean
665913|NCT01765153|Secondary|Change in Center for Epidemiologic Studies - Depression Scale (CES-D) at the End of 2 Months of Rest Period I|"A 20 question survey to measure current level of depressive symptoms.The participant ranks their emotional state or actions for each question on an ordinal scale of 0 to 3, with 0 indicating rarely or never and 3 being most of the time. A minimum score of 0 indicates no depressive symptoms, and a score of 10 or greater is considered indicative of depression. The max score for the scale is 60.
Results are reported as Final score - Initial score. A negative result indicates a lower level of depression."|Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I|||units on a scale||Standard Deviation|Mean
665914|NCT01765153|Secondary|Change in Center for Epidemiologic Studies - Depression Scale (CES-D) at 2 Months of Training Phase I|"A 20 question survey to measure current level of depressive symptoms. The participant ranks their emotional state or actions for each question on an ordinal scale of 0 to 3, with 0 indicating rarely or never and 3 being most of the time. A minimum score of 0 indicates no depressive symptoms, and a score of 10 or greater is considered indicative of depression. The max score for the scale is 60.
Results are reported as Final score - Initial score. A negative result indicates a lower level of depression."|Change from Baseline I to 2 months of Training Phase I|||units on a scale||Standard Deviation|Mean
665915|NCT01765153|Secondary|Change in Activities-specific Balance Confidence Scale (ABC) at the End of 2 Months of Rest Period II|"A survey with 16 questions regarding the participants confidence in their ability to perform specific tasks requiring balance. Participants rate their confidence as a percentage from 0% (no confidence in their ability to perform the task) to 100% 9 completely confident in their ability to complete the task safely. Total score is calculated as: Sum of item scores/16 and is expressed as a percentage.
Results are reported as Final score - Initial score. A positive result indicates a higher level of confidence in ability."|Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II|||percentage of confidence in balance||Standard Deviation|Mean
665916|NCT01765153|Secondary|Change in Activities-specific Balance Confidence Scale (ABC) at 2 Months of Training Phase II|"A survey with 16 questions regarding the participants confidence in their ability to perform specific tasks requiring balance. Participants rate their confidence as a percentage from 0% (no confidence in their ability to perform the task) to 100% 9 completely confident in their ability to complete the task safely. Total score is calculated as: Sum of item scores/16 and is expressed as a percentage.
Results are reported as Final score - Initial score. A positive result indicates a higher level of confidence in ability."|Change from Baseline II to 2 months of Training Phase II|||Percentage of confidence in balance||Standard Deviation|Mean
665917|NCT01765153|Secondary|Change in Activities-specific Balance Confidence Scale (ABC) at the End of 2 Months of Rest Period I|"A survey with 16 questions regarding the participants confidence in their ability to perform specific tasks requiring balance. Participants rate their confidence as a percentage from 0% (no confidence in their ability to perform the task) to 100% 9 completely confident in their ability to complete the task safely. Total score is calculated as: Sum of item scores/16 and is expressed as a percentage.
Results are reported as Final score - Initial score. A positive result indicates a higher level of confidence in ability."|Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I|||percentage of confidence in balance||Standard Deviation|Mean
665918|NCT01765153|Secondary|Change in Activities-specific Balance Confidence Scale (ABC) at 2 Months of Training Phase I|"A survey with 16 questions regarding the participants confidence in their ability to perform specific tasks requiring balance. Participants rate their confidence as a percentage from 0% (no confidence in their ability to perform the task) to 100% 9 completely confident in their ability to complete the task safely. Total score is calculated as: Sum of item scores/16 and is expressed as a percentage.
Results are reported as Final score - Initial score. A positive result indicates a higher level of confidence in ability."|Change from Baseline I to 2 months of Training Phase I|||percentage of confidence in balance||Standard Deviation|Mean
665919|NCT01765153|Secondary|Change in Walking Index for Spinal Cord Injury Version II Maximum [WISCI-II (Max)] at the End of 2 Months of Rest Period II|"Participants are scored from 0 to 20 based on the least amount of assistance/aid they require to walk a distance of 10 meters. Walking aids and physical assistance provided are ranked on an ordinal scale from 1 to 20. A score of 0 indicates the participant is unable to walk 10 m, 20 indicates no aids are required to complete the task.
Results are reported as Final score - Initial score. A positive result indicates that less assistance was required."|Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II|||units on a scale||Standard Deviation|Mean
665920|NCT01765153|Secondary|Change in Walking Index for Spinal Cord Injury Version II Maximum [WISCI-II (Max)] at 2 Months of Training Phase II|"Participants are scored from 0 to 20 based on the least amount of assistance/aid they require to walk a distance of 10 meters. Walking aids and physical assistance provided are ranked on an ordinal scale from 1 to 20. A score of 0 indicates the participant is unable to walk 10 m, 20 indicates no aids are required to complete the task.
Results are reported as Final score - Initial score. A positive result indicates that less assistance was required."|Change from Baseline II to 2 months of Training Phase II|Measure was added to study protocol midway through study. 1 out of 18 participants did not complete this measure at this time point. Data analysed for all participants who performed this measure.||units on a scale||Standard Deviation|Mean
665921|NCT01765153|Secondary|Change in Walking Index for Spinal Cord Injury Version II Maximum [WISCI-II (Max)] at the End of 2 Months of Rest Period I|"Participants are scored from 0 to 20 based on the least amount of assistance/aid they require to walk a distance of 10 meters. Walking aids and physical assistance provided are ranked on an ordinal scale from 1 to 20. A score of 0 indicates the participant is unable to walk 10 m, 20 indicates no aids are required to complete the task.
Results are reported as Final score - Initial score. A positive result indicates that less assistance was required."|Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I|Measure was added to study protocol midway through study. 2 out of 17 participants did not complete this measure at this time point. Data analysed for all participants who performed this measure.||units on a scale||Standard Deviation|Mean
665922|NCT01765153|Secondary|Change in Walking Index for Spinal Cord Injury Version II Maximum [WISCI-II (Max)] at 2 Months of Training Phase I|"Participants are scored from 0 to 20 based on the least amount of assistance/aid they require to walk a distance of 10 meters. Walking aids and physical assistance provided are ranked on an ordinal scale from 1 to 20. A score of 0 indicates the participant is unable to walk 10 m, 20 indicates no aids are required to complete the task.
Results are reported as Final score - Initial score. A positive result indicates that less assistance was required."|Change from Baseline I to 2 months of Training Phase I|Measure was added to study protocol midway through study. 3 out of 19 participants did not complete this measure at this time point. Data analysed for all participants who performed this measure.||units on a scale||Standard Deviation|Mean
666030|NCT01763905|Primary|Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set with available data (no imputation was performed).||percent change||Standard Error|Least Squares Mean
665923|NCT01765153|Secondary|Change in Walking Index for Spinal Cord Injury Version II Self-selected (WISCI-II ss) at the End of 2 Months of Rest Period II|"Participants are scored from 0 to 20 based on the walking aid they select to walk a distance of 10 meters. Walking aids and physical assistance provided are ranked on an ordinal scale from 1 to 20. A score of 0 indicates the participant is unable to walk 10 m, 20 indicates no aids are required to complete the task.
Results are reported as Final score - Initial score. A positive result indicates that less assistance was required."|Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II|||units on a scale||Standard Deviation|Mean
665924|NCT01765153|Secondary|Change in Walking Index for Spinal Cord Injury Version II Self-selected (WISCI-II ss) at 2 Months of Training Phase II|"Participants are scored from 0 to 20 based on the walking aid they select to walk a distance of 10 meters. Walking aids and physical assistance provided are ranked on an ordinal scale from 1 to 20. A score of 0 indicates the participant is unable to walk 10 m, 20 indicates no aids are required to complete the task.
Results are reported as Final score - Initial score. A positive result indicates that less assistance was required."|Change from Baseline II to 2 months of Training Phase II|||units on a scale||Standard Deviation|Mean
665925|NCT01765153|Secondary|Change in Walking Index for Spinal Cord Injury Version II Self-selected (WISCI-II ss) at the End of 2 Months of Rest Period I|"Participants are scored from 0 to 20 based on the walking aid they select to walk a distance of 10 meters. Walking aids and physical assistance provided are ranked on an ordinal scale from 1 to 20. A score of 0 indicates the participant is unable to walk 10 m, 20 indicates no aids are required to complete the task.
Results are reported as Final score - Initial score. A positive result indicates that less assistance was required."|Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I|||units on a scale||Standard Deviation|Mean
665926|NCT01765153|Secondary|Change in Walking Index for Spinal Cord Injury Version II Self-selected (WISCI-II ss) at 2 Months of Training Phase I|"Participants are scored from 0 to 20 based on the walking aid they select to walk a distance of 10 meters. Walking aids and physical assistance provided are ranked on an ordinal scale from 1 to 20. A score of 0 indicates the participant is unable to walk 10 m, 20 indicates no aids are required to complete the task.
Results are reported as Final score - Initial score. A positive result indicates that less assistance was required."|Change from Baseline I to 2 months of Training Phase I|||units on a scale||Standard Deviation|Mean
665927|NCT01765153|Secondary|Change in 10 Meter Walk Test at a Fast Speed [10MWT(f)] at the End of 2 Months of Rest Period II|Participants walk as quickly as they are able to along a 14 meter path on a smooth floor. The middle 10 m is timed. Speed over 10 m is calculated as 10 m/Time. Results are calculated as: Final speed - initial speed.|Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II|Measure was added to study protocol midway through study. 2 out of 16 participants did not complete this measure at this time point. Data analysed for all participants who performed this measure.||m/s||Standard Deviation|Mean
665928|NCT01765153|Secondary|Change in 10 Meter Walk Test at a Fast Speed [10MWT(f)] at 2 Months of Training Phase II|Participants walk as quickly as they are able to along a 14 meter path on a smooth floor. The middle 10 m is timed. Speed over 10 m is calculated as 10 m/Time. Results are calculated as: Final speed - initial speed.|Change from Baseline II to 2 months of Training Phase II|Measure was added to study protocol midway through study. 3 out of 18 participants did not complete this measure at this time point. Data analysed for all participants who performed this measure.||m/s||Standard Deviation|Mean
665929|NCT01765153|Secondary|Change in 10 Meter Walk Test at a Fast Speed [10MWT(f)] at the End of 2 Months of Rest Period I|Participants walk as quickly as they are able to along a 14 meter path on a smooth floor. The middle 10 m is timed. Speed over 10 m is calculated as 10 m/Time. Results are calculated as: Final speed - initial speed.|Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I|Measure was added to study protocol midway through study. 4 out of 18 participants did not complete this measure at this time point. Data analysed for all participants who performed this measure.||m/s||Standard Deviation|Mean
665930|NCT01765153|Secondary|Change in 10 Meter Walk Test at a Fast Speed [10MWT(f)] at 2 Months of Training Phase I|Participants walk as quickly as they are able to along a 14 meter path on a smooth floor. The middle 10 m is timed. Speed over 10 m is calculated as 10 m/Time. Results are calculated as: Final speed - initial speed.|Change from Baseline I to 2 months of Training Phase I|Measure was added to study protocol midway through study. 5 out of 19 participants did not complete this measure at this time point. Data analysed for all participants who performed this measure.||m/s||Standard Deviation|Mean
665931|NCT01765153|Secondary|Change in 10 Meter Walk Test at a Self-selected Speed [10MWT(ss)] at the End of 2 Months of Rest Period II|Participants walk along a 14 meter path on a smooth floor at a comfortable pace. The middle 10 m is timed. Speed over 10 m is calculated as 10 m/Time. Results are calculated as: Final speed - initial speed.|Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II|||m/s||Standard Deviation|Mean
665932|NCT01765153|Secondary|Change in 10 Meter Walk Test at a Self-selected Speed [10MWT(ss)] at 2 Months of Training Phase II|Participants walk along a 14 meter path on a smooth floor at a comfortable pace. The middle 10 m is timed. Speed over 10 m is calculated as 10 m/Time. Results are calculated as: Final speed - initial speed.|Change from Baseline II to 2 months of Training Phase II|||m/s||Standard Deviation|Mean
665933|NCT01765153|Secondary|Change in 10 Meter Walk Test at a Self-selected Speed [10MWT(ss)] at the End of 2 Months of Rest Period I|Participants walk along a 14 meter path on a smooth floor at a comfortable pace. The middle 10 m is timed. Speed over 10 m is calculated as 10 m/Time. Results are calculated as: Final speed - initial speed.|Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I|||m/s||Standard Deviation|Mean
665934|NCT01765153|Secondary|Change in 10 Metre Walk Test at a Self-selected Speed [10MWT(ss)] at 2 Months of Training Phase I|Participants walk along a 14 meter path on a smooth floor at a comfortable pace. The middle 10 m is timed. Speed over 10 m is calculated as 10 m/Time. Results are calculated as: Final speed - initial speed.|Change from Baseline I to 2 months of Training Phase I|||m/s||Standard Deviation|Mean
665935|NCT01765153|Secondary|Change in 6 Minute Walk Test (6MWT) at the End of 2 Months of Rest Period II|Participants walk for as far as possible in 6 min along a 25m hallway. Total distance walked in the time is measured. Results are calculated as : Distance walked at end of period - Distance walked at beginning of period.|Change from the end of Phase II training to 2 months of Rest Period II|||metres||Standard Deviation|Mean
665937|NCT01765153|Secondary|Change in 6 Minute Walk Test (6MWT) at the End of 2 Months of Rest Period I|Participants walk for as far as possible in 6 min along a 25m hallway. Total distance walked in the time is measured. Results are calculated as : Distance walked at end of period - Distance walked at beginning of period.|Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I|||metres||Standard Deviation|Mean
665938|NCT01765153|Secondary|Change in 6 Minute Walk Test (6MWT) at 2 Months of Training Phase I|Participants walk for as far as possible in 6 min along a 25m hallway.|Change from Baseline I to 2 months of Training Phase I|||metres||Standard Deviation|Mean
665939|NCT01765153|Secondary|Change in Spinal Cord Injury - Functional Ambulation Profile (SCI-FAP) at the End of 2 Months of Rest Period II|This is a 7 item, timed walking test. Participants perform each of the walking tasks and the time to complete each task is recorded. Maximum times are set for each task. An assistance category is assigned based on the walking aids used, with 1 being no aid and 6 being unable to complete the task. A score for each item is calculated as: Time x Assistance factor/Mean able bodied time. A composite (single) score is obtained by summing the scores for all 7 items. The maximum score for the scale is 2100 indicating that the participant was unable to complete any of the 7 tasks within the allowed time. A minimum score of 7 indicates that all tasks were performed with no aids and at the mean able-bodied time. Results are reported as a measure of change: Final score - initial score. A negative result indicates improvement.|Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II|||units on a scale||Standard Deviation|Mean
665940|NCT01765153|Secondary|Change in Spinal Cord Injury - Functional Ambulation Profile (SCI-FAP) at 2 Months of Training Phase II|This is a 7 item, timed walking test. Participants perform each of the walking tasks and the time to complete each task is recorded. Maximum times are set for each task. An assistance category is assigned based on the walking aids used, with 1 being no aid and 6 being unable to complete the task. A score for each item is calculated as: Time x Assistance factor/Mean able bodied time. A composite (single) score is obtained by summing the scores for all 7 items. The maximum score for the scale is 2100 indicating that the participant was unable to complete any of the 7 tasks within the allowed time. A minimum score of 7 indicates that all tasks were performed with no aids and at the mean able-bodied time. Results are reported as a measure of change: Final score - initial score. A negative result indicates improvement.|Change from Baseline II to 2 months of Training Phase II|||units on a scale||Standard Deviation|Mean
665941|NCT01765153|Secondary|Change in Spinal Cord Injury - Functional Ambulation Profile (SCI-FAP) at the End of 2 Months of Rest Period I|This is a 7 item, timed walking test. Participants perform each of the walking tasks and the time to complete each task is recorded. Maximum times are set for each task. An assistance category is assigned based on the walking aids used, with 1 being no aid and 6 being unable to complete the task. A score for each item is calculated as: Time x Assistance factor/Mean able bodied time. A composite (single) score is obtained by summing the scores for all 7 items. The maximum score for the scale is 2100 indicating that the participant was unable to complete any of the 7 tasks within the allowed time. A minimum score of 7 indicates that all tasks were performed with no aids and at the mean able-bodied time. Results are reported as a measure of change: Final score - initial score. A negative result indicates improvement.|Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I|||units on a scale||Standard Deviation|Mean
665942|NCT01765153|Secondary|Change in Spinal Cord Injury - Functional Ambulation Profile (SCI-FAP) at 2 Months of Training Phase I|This is a 7 item, timed walking test. Participants perform each of the walking tasks and the time to complete each task is recorded. Maximum times are set for each task. An assistance category is assigned based on the walking aids used, with 1 being no aid and 6 being unable to complete the task. A score for each item is calculated as: Time x Assistance factor/Mean able bodied time. A composite (single) score is obtained by summing the scores for all 7 items. The maximum score for the scale is 2100 indicating that the participant was unable to complete any of the 7 tasks within the allowed time. A minimum score of 7 indicates that all tasks were performed with no aids and at the mean able-bodied time. Results are reported as a measure of change: Final score - initial score. A negative result indicates improvement.|Change from Baseline I to 2 months of Training Phase I|||units on a scale||Standard Deviation|Mean
665943|NCT01765153|Primary|Change in Spinal Cord Injury - Functional Ambulation Profile (SCI-FAP) at Completion of Study|This is a 7 item, timed walking test. Participants perform each of the walking tasks and the time to complete each task is recorded. Maximum times are set for each task. An assistance category is assigned based on the walking aids used, with 1 being no aid and 6 being unable to complete the task. A score for each item is calculated as: Time x Assistance factor/Mean able bodied time. A composite (single) score is obtained by summing the scores for all 7 items. The maximum score for the scale is 2100 indicating that the participant was unable to complete any of the 7 tasks within the allowed time. A minimum score of 7 indicates that all tasks were performed with no aids and at the mean able-bodied time. Results are reported as a measure of change: Final score - initial score. A negative result indicates improvement.|Change from Baseline I to the end of the study (i.e., end of Rest Period II, which was ~8 months after the beginning of the study)|||units on a scale||Standard Deviation|Mean
665944|NCT01764997|Secondary|Change From Baseline in DAS28-CRP Score at Week 12||Baseline, Week 12|As the number of participants randomized fell well below target (43 vs. 699), the efficacy data were not systematically collected or cleaned and no datasets have been created to report.|||||
665945|NCT01764997|Secondary|Percentage of Participants Achieving Clinical Remission Score (DAS28-CRP) <2.6 at Week 12 and Week 24||Week 12 and Week 24|As the number of participants randomized fell well below target (43 vs. 699), the efficacy data were not systematically collected or cleaned and no datasets have been created to report.|||||
665946|NCT01764997|Secondary|Number of Participants With at Least 20% Improvement in American College of Rheumatology (ACR20), at Least 50% Improvement in ACR (ACR50) and at Least 70% Improvement in ACR (ACR70) Efficacy Response Rates at Week 12 and Week 24||Week 12 and Week 24|As the number of participants randomized fell well below target (43 vs. 699), the efficacy data were not systematically collected or cleaned and no datasets have been created to report.|||||
665947|NCT01764997|Primary|Change From Baseline in Disease Activity Score for 28 Joints - C-Reactive Protein (DAS28-CRP) Score at Week 24||Baseline, Week 24|As the number of participants randomized fell well below target (43 vs. 699), the efficacy data were not systematically collected or cleaned and no datasets have been created to report.|||||
665948|NCT01764945|Primary|AUC0-tz|"Area under the concentration-time curve of the analyte (faldaprevir) in plasma over the time interval from 0 to the time of the last quantifiable data point.
The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|-1:00, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 7:00, 8:00, 9:00, 10:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00 h after administration of faldaprevir on Day 1.|PK set.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
665949|NCT01764945|Primary|Cmax|Maximum measured concentration of the analyte (faldaprevir) in plasma. The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.|-1:00, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 7:00, 8:00, 9:00, 10:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00 h after administration of faldaprevir on Day 1.|PK set.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
665950|NCT01764945|Primary|AUC0-∞|"Area under the concentration-time curve of the analyte (faldaprevir) in plasma over the time interval from 0 extrapolated to infinity.
The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|-1:00, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 7:00, 8:00, 9:00, 10:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00 h (hours) after administration of faldaprevir on Day 1.|Pharmacokinetic analysis set (PK set) includes all subjects who provided evaluable data for at least 1 evaluable observation for a PK endpoint in at least 1 treatment period.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
665951|NCT01764919|Other Pre-specified|Explore the Performance of [124I]FIAU PET-CT Compared to MRI in Detecting Osteomyelitis by Chronic Kidney Disease (CKD) Stage (Stage 1+2, Stage 3, and Stage 4+5).||-2 hours to 72 hours post dose [124I]FIAU|No correlation was seen between FIAU uptake and bone biopsy results (the standard of truth). The secondary and exploratory efficacy endpoints were not assessed.|||||
665952|NCT01764919|Secondary|Assess Any Additional Information That [124I]FIAU PET-CT Scanning Provides Compared to MRI|Additional information on the extent and localization of infection will be compared to MRI.|-2 to 72 hours post dose [124I]FIAU|No correlation was seen between FIAU uptake and bone biopsy results (the standard of truth). The secondary and exploratory efficacy endpoints were not assessed.|||||
665953|NCT01764919|Secondary|Compare the Sensitivity and Specificity of [124I]FIAU PET-CT Scanning to Gadolinium-enhanced (GE) Magnetic Resonance Imaging (MRI) and Non-GE-MRI Scanning in Detecting Osteomyelitis in Patients With Diabetic Foot Infection|All PET-CT images will be evaluated centrally and independently by a single radiologist. Diagnosis of osteomyelitis based on PET-CT will be compared with MRI which is currently the test of choice to diagnose osteomyelitis in diabetic foot infection.|-2 to 72 hours post dose [124I]FIAU|No correlation was seen between FIAU uptake and bone biopsy results (the standard of truth). The secondary and exploratory efficacy endpoints were not assessed.|||||
665954|NCT01764919|Secondary|Assess the Safety and Tolerability of [124I]FIAU|Safety will be monitored for all subjects for the duration of their study participation. Safety will be assessed by monitoring of adverse events,vital signs, physical exams, and clinical laboratory tests including CBC and serum chemistry.|30 +/- 2 days|||participants with adverse events|||Number
665955|NCT01764919|Primary|Assess the Sensitivity and Specificity of [124I]FIAU PET-CT Scanning in Detecting Osteomyelitis as Determined by Bone Biopsy in Patients With Diabetic Foot Infection.|A bone biopsy was obtained through a noninfected area and submitted for histology and microbiologic culture. Cultures were also to be obtained by biopsy after debridement of the ulcer from a clean base. Subjects were dosed with [124I]FIAU. PET-CT scanning were performed. All PET, PET-CT, and CT images, both attenuation corrected and uncorrected, were to be evaluated centrally and independently. Results from the bone biopsies were not available to the central reader of the PET-CT images. The sensitivity and specificity of [124I]FIAU PET-CT scanning in detecting osteomyelitis was determined based on its correlation with bone biopsy, the truth standard.|30 hours|||participants|||Number
665956|NCT01764841|Secondary|Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at End of Treatment (Week 44/46)|FEV1 was defined as the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration, expressed in liters at body temperature and ambient pressure saturated with water vapor (BTPS).|Baseline and end of treatment (Week 44/46)|FAS with participants evaluable for this outcome measure.||Liter||Standard Deviation|Mean
665957|NCT01764841|Secondary|Mean Change From Baseline in Patient Reported Outcome Quality of Life Questionnaire for Bronchiectasis (QoL-B) Respiratory Symptoms Domain Score at End of Treatment (Week 44/46)|The QoL-B was a disease-specific questionnaire developed for non-Cystic fibrosis Bronchiectasis. It covers 8 dimensions: physical functioning, role functioning, emotional functioning, social functioning, vitality, treatment burden, health perceptions, and respiratory symptoms. Each dimension was scored separately on a scale of 0 to 100, and higher scores represent better outcomes. For this outcome measure, the respiratory symptoms domain score was reported.|Baseline and end of treatment (Week 44/46)|FAS with participants evaluable for this outcome measure.||Score on a scale||Standard Deviation|Mean
665958|NCT01764841|Secondary|Percentage of Participants With Occurrence of New Pathogens Present at End of Treatment (Week 44/46)|New pathogens were any of the pre-specified organisms not cultured before start of study medication. There was no imputation for participants who discontinued the study prematurely.|End of treatment (Week 44/46)|Full analysis set (FAS) included participants who were randomized.||Percentage of Participants|||Number
665959|NCT01764841|Secondary|Mean Change From Baseline in Patient Reported Outcome Saint George's Respiratory Questionnaire (SGRQ) Symptoms Component Score at End of Treatment (Week 44/46)|The SGRQ was a validated, disease-specific instrument that measures health-related quality of life (HRQoL) in adults with chronic obstructive pulmonary disease (COPD) and asthma and was later validated for use in bronchiectasis. The SGRQ covers 3 dimensions: symptoms, activity and impact on daily life. To determine the outcome, a score ranging from 1 to 100 was calculated for each individual domain and for the total score, and smaller scores indicate better health status. For this outcome measure, the symptoms component score was reported.|Baseline and end of treatment (Week 44/46)|FAS with participants evaluable for this outcome measure.||Score on a scale||Standard Deviation|Mean
665960|NCT01764841|Secondary|Percentage of Participants With Pathogen Eradication at End of Treatment (Week 44/46)|Pathogen eradication was defined as a negative culture result for all pre-specified pathogens at end of treatment (week 44 or 46 depending on treatment regimen) that were present in the participant at baseline. There was no imputation for participants who discontinued the study prematurely.|End of treatment (Week 44/46)|Full analysis set (FAS) included participants who were randomized.||Percentage of Participants|||Number
665962|NCT01764841|Secondary|Number of Participants With Exacerbation Events With Worsening of at Least Three Signs/Symptoms Over 48 Weeks|For this outcome measure, exacerbation events were defined as exacerbations with systemic antibiotic use and presence of fever or malaise / fatigue and worsening of at least three signs/symptoms over 48 weeks.|Up to Week 48|Full analysis set (FAS) included participants who were randomized.||Participants|||Count of Participants
665963|NCT01764841|Primary|Time to First Exacerbation Event Within 48 Weeks|Time to first exacerbation was defined as the time from randomization until the visit at which the first qualifying exacerbation is recorded by the investigator. Exacerbation events are defined as exacerbations with systemic antibiotic use and presence of fever or malaise / fatigue and worsening of at least three signs/symptoms.|Up to Week 48|Full analysis set (FAS) included participants who were randomized.||Days||97.5% Confidence Interval|Median
665964|NCT01764685|Primary|Number of Heavy Drinking Days Per Week by Medication Group|Total number of heavy drinking days (>4 drinks for men; >3 drinks for women) for the placebo + medical management group during the study period. No data analysis will be done due to the small sample size and fact that all subjects received placebo study medication.|11-week study period|Data was only collected on 3 of the 4 subjects.||Number of heavy drinking days/week|||Number
665965|NCT01764607|Secondary|Evaluation of Skin Tumor for Squamous Cell Skin Carcinoma|Tumor will be analyzed at baseline and time of surgical removal by both laboratory and microscopic testing.|At baseline and time of surgical removal (5 weeks).|||percentage of baseline size|||Number
665966|NCT01764607|Primary|Measure of Squamous Cell Skin Carcinoma in Patients|Baseline: Measuring of squamous cell skin carcinoma, Week 5: Measuring and surgical removal of squamous cell skin cancer with microscopic evaluation, and in 1 year.|Baseline, time of surgical removal (5 weeks) and 1 year.|||mm|||Number
665967|NCT01764386|Secondary|Change in Patient-reported Impact of Weight on Quality of Life-Lite Questionnaire (IWQOL-Lite) Total Score From Baseline to Week 26|Impact of Weight on Quality of Life-Lite Questionnaire (IWQOL-Lite) is a self-reported assessment of perceived effect of weight on quality of life. It consists of 31 items organized in 5 domains (physical function, self-esteem, sexual life, public distress and work). IWQOL-Lite total score is based on a scale from 0 to 100, with 0 representing the poorest and 100 the best quality of life and where a score of 71-79 indicates moderate impairment.|Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.||units on a scale||Standard Error|Least Squares Mean
665968|NCT01764386|Secondary|Change in Patient-reported Arizona Sexual Experiences Scale (ASEX) Total Scores From Baseline to Week 26|Arizona Sexual Experiences (ASEX) scale is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm. Possible total scores range from 5 to 30, with the higher scores indicating more sexual dysfunction.|Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.||units on a scale||Standard Error|Least Squares Mean
665969|NCT01764386|Secondary|Change in Patient-reported Binge Eating Scale (BES) Total Scores From Baseline to Week 26|The BES is a 16-item questionnaire that identifies different levels of binge-eating severity, with total scores ranging between 0-46. BES scores were categorized as follows: None = Scores ≤17 indicated no significant binge eating, Moderate = scores from 18 to 26 (inclusive), Severe = scores ≥27 indicated severe levels of binge eating.|Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.||units on a scale||Standard Error|Least Squares Mean
665970|NCT01764386|Secondary|Change in Homeostasis Model Assessment-insulin Resistance (HOMA-IR) From Baseline to Week 26|HOMA-IR is an insulin sensitivity index that is calculated as HOMA-IR = (Glucose * Insulin) / 405, where glucose is in mass units (mg/dL) and insulin is in µIU/mL. Higher values indicate lower insulin sensitivity.|Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.||units on a scale||Standard Error|Least Squares Mean
665971|NCT01764386|Secondary|Change Fasting Insulin From Baseline to Week 26||Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.||uIU/mL||Standard Error|Least Squares Mean
665972|NCT01764386|Secondary|Change in Fasting Plasma Glucose From Baseline to Week 26||Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.||mg/dL||Standard Error|Least Squares Mean
665973|NCT01764386|Secondary|Change in Heart Rate From Baseline to Week 26||Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.||bpm||Standard Error|Least Squares Mean
665974|NCT01764386|Secondary|Change in Diastolic Blood Pressure From Baseline to Week 26||Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.||mm Hg||Standard Error|Least Squares Mean
665975|NCT01764386|Secondary|Change in Systolic Blood Pressure From Baseline to Week 26||Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.||mm Hg||Standard Error|Least Squares Mean
665976|NCT01764386|Secondary|Change in Fasting High-density Lipoprotein Cholesterol From Baseline to Week 26||Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.||mg/dL||Standard Error|Least Squares Mean
665977|NCT01764386|Secondary|Change in Fasting Low-density Lipoprotein Cholesterol From Baseline to Week 26||Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.||mg/dL||Standard Error|Least Squares Mean
665978|NCT01764386|Secondary|Change in Fasting Triglycerides From Baseline to Week 26||Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.||mg/dL||Standard Error|Least Squares Mean
665979|NCT01764386|Secondary|Change in Waist Circumference From Baseline to Week 26||Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.||cm||Standard Error|Least Squares Mean
665980|NCT01764386|Secondary|Absolute Change in Body Weight From Baseline to Week 26||Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.||kg||Standard Error|Least Squares Mean
665981|NCT01764386|Secondary|Percentage of Subjects Achieving a Loss of at Least 15% of Baseline Body Weight at Week 26||Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.||percentage of participants|||Number
665982|NCT01764386|Secondary|Percentage of Subjects Achieving a Loss of at Least 10% of Baseline Body Weight at Week 26||Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.||percentage of participants|||Number
665983|NCT01764386|Secondary|Percentage of Subjects Achieving a Loss of at Least 5% of Baseline Body Weight at Week 26||Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.||percentage of participants|||Number
665984|NCT01764386|Primary|Percent Change in Body Weight From Baseline (Day 1) to Week 26||Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.||percent change in body weight||Standard Error|Least Squares Mean
665985|NCT01764022|Secondary|T1/2|secondary outcome measure for PK substudy|Up to Day 22|Patients who received one dose of study drug and after 504 hours after the injection had missed <= 1 blood sample collection to analyse pharmacokinetics.||hours||Inter-Quartile Range|Median
665986|NCT01764022|Secondary|Tmax|secondary outcome measure for PK substudy|Up to Day 22|Patients who received one dose of study drug and after 504 hours after the injection had missed <= 1 blood sample collection to analyse pharmacokinetics.||hours||Inter-Quartile Range|Median
665987|NCT01764022|Secondary|Cmax|secondary outcome measure for PK substudy|Up to Day 22|Patients who received one dose of study drug and after 504 hours after the injection had missed <= 1 blood sample collection to analyse pharmacokinetics.||µg/ml||Inter-Quartile Range|Median
665988|NCT01764022|Secondary|Occurrence of Anti-trastuzumab Antibodies|Secondary outcome measure for immunogenicity assessment|Day 1 (before the drug administration), Day 15, 64 and 127|Patients who received at least one injection of study drug.||participants|||Number
665989|NCT01764022|Secondary|Treatment Discontinuation Rate Due to AE|secondary outcome measure for safety evaluation|Day 127|Patients who received at least one injection of study drug.||participants|||Number
665990|NCT01764022|Secondary|Number of Patients in Whom Chemotherapy Cycles Had Been Postponed Due to Adverse Events (AE)|secondary outcome measure for safety evaluation|Day 127|Patients who received at least one injection of study drug.||participants|||Number
665991|NCT01764022|Secondary|Progression Rate|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
The response was assessed at the screening, after 3 therapy cycles and after 6 therapy cycles. If CT after 3 or 6 therapy cycles revealed the complete or partial response, a confirmatory CT scan was performed 4 weeks later. The best response during the study was assessed."|Day 127|The population for efficacy analysis included patients who received at least one injection of study drug and had evaluable results of treatment.||percentage of patients||95% Confidence Interval|Mean
665992|NCT01764022|Secondary|Stabilization Rate|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
The response was assessed at the screening, after 3 therapy cycles and after 6 therapy cycles. If CT after 3 or 6 therapy cycles revealed the complete or partial response, a confirmatory CT scan was performed 4 weeks later. The best response during the study was assessed."|Day 127|The population for efficacy analysis included patients who received at least one injection of study drug and had evaluable results of treatment.||percentage of patients||95% Confidence Interval|Mean
665993|NCT01764022|Secondary|Partial Response Rate|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
The response was assessed at the screening, after 3 therapy cycles and after 6 therapy cycles. If CT after 3 or 6 therapy cycles revealed the complete or partial response, a confirmatory CT scan was performed 4 weeks later. The best response during the study was assessed."|Day 127|The population for efficacy analysis included patients who received at least one injection of study drug and had evaluable results of treatment.||percentage of patients||95% Confidence Interval|Mean
665994|NCT01764022|Secondary|Complete Response Rate|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
The response was assessed at the screening, after 3 therapy cycles and after 6 therapy cycles. If CT after 3 or 6 therapy cycles revealed the complete or partial response, a confirmatory CT scan was performed 4 weeks later. The best response during the study was assessed."|Day 127|The population for efficacy analysis included patients who received at least one injection of study drug and had evaluable results of treatment.||percentage of patients||95% Confidence Interval|Mean
665995|NCT01764022|Primary|Area Under the Curve After the First Test Drug Administration|primary outcome measure for pharmacokinetics (PK) substudy|up to Day 22, after the first trastuzumab administration (time points for blood samples: 0 h 1.5 h, 3 h, 4.5 h, 6 h, 24 h, 96 h, 168 h, 336 h and 504 h)|Patients who received one dose of study drug and after 504 hours after the injection had missed <= 1 blood sample collection to analyse pharmacokinetics.||(µg/ml)*hour||Inter-Quartile Range|Median
665996|NCT01764022|Primary|Overall Response Rate|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
The response was assessed at the screening, after 3 therapy cycles and after 6 therapy cycles. If CT after 3 or 6 therapy cycles revealed the complete or partial response, a confirmatory CT scan was performed 4 weeks later. The best response during the study was assessed."|Day 127|The population for efficacy analysis included patients who received at least one injection of study drug and had evaluable results of treatment.||percentage of patients||95% Confidence Interval|Number
665997|NCT01763996|Secondary|Exercise Duration|Exercise duration is the exercise time in seconds during ETT. Data at the end of each period was combined for the febuxostat and the placebo arms.|At the end of each 6 week treatment period (Week 6 and Week 12)|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug, with data available.||seconds||95% Confidence Interval|Least Squares Mean
665998|NCT01763996|Secondary|Time to Onset of Angina During Exercise Treadmill Test at the End of the Administration of Febuxostat and Placebo|Time in seconds to ischemic chest pain/ angina during ETT. Data at the end of each period was combined for the febuxostat and the placebo arms|At the end of each 6 week treatment period (Week 6 and Week 12)|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug, with ischemic chest pain.||seconds||Standard Deviation|Mean
665999|NCT01763996|Secondary|Percentage of Participants Stopping Exercise Treadmill Test Due to Angina at the End of the Administration of Febuxostat and Placebo|An exercise treadmill test (modified Bruce protocol) was performed. Data at the end of each treatment period was combined for the febuxostat and the placebo arms.|At the end of each 6 week treatment period (Week 6 and Week 12)|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug, with data available.||percentage of participants|||Number
666000|NCT01763996|Secondary|Change in Maximum ST-segment Depression During Exercise Treadmill Test|Continuous ECG was performed during an exercise treadmill test (modified Bruce protocol) to assess the maximum ST-segment depression after 6 weeks of febuxostat or placebo treatment in participants with a normal ST segment at randomization. A negative change from Baseline indicates improvement. Data at the end of each treatment period was combined for the febuxostat and the placebo arms.|Baseline and at the end of each 6 week treatment period (Week 6 and Week 12)|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug, with ST segment change.||mm||Standard Deviation|Mean
666001|NCT01763996|Secondary|Change in Time to Onset of ≥1 mm ST-Segment Depression During Exercise Treadmill Test (ETT)|Time in seconds to ischemic ECG changes during ETT. Continuous electrocardiography (ECG) was performed during an exercise treadmill test (modified Bruce protocol) to assess the onset of ST-segment depression after administration of febuxostat or placebo for 6 weeks in participants with a normal ST segment at randomization. . Data at the end of each treatment period was combined for the febuxostat and the placebo arms.|Baseline and at the end of each 6 week treatment period (Week 6 and Week 12)|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug, with ischemic ECG changes.||seconds||Standard Deviation|Mean
666002|NCT01763996|Secondary|Change in Coronary Flow Velocity Following the Administration of Sublingual Nitroglycerin at the End of the Administration of Febuxostat and Placebo|Coronary flow velocity was measured by MRI before and following administration of nitroglycerin under the tongue. Data at the end of each treatment period was combined for the febuxostat and the placebo arms. A positive change from Baseline indicates improvement.|Baseline and at the end of each 6 week treatment period (Week 6 and Week 12)|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug, who used nitroglycerin.||cm/second||95% Confidence Interval|Least Squares Mean
666003|NCT01763996|Secondary|Change in Coronary Artery Cross Sectional Area Following the Administration of Sublingual Nitroglycerin at the End of the Administration of Febuxostat and Placebo|Coronary artery cross sectional area was measured by MRI before and following administration of nitroglycerin under the tongue. Data at the end of each treatment period was combined for the febuxostat and the placebo arms. A positive change from Baseline indicates improvement.|Baseline and at the end of each 6 week treatment period (Week 6 and Week 12)|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug, who used nitroglycerin.||mm^2||95% Confidence Interval|Least Squares Mean
666004|NCT01763996|Secondary|Change in Coronary Artery Flow Following the Administration of Sublingual Nitroglycerin at the End of the Administration of Febuxostat and Placebo|Coronary artery flow was measured by MRI before and following administration of nitroglycerin under the tongue. Data at the end of each treatment period was combined for the febuxostat and the placebo arms. A positive change from Baseline indicates improvement.|Baseline and at the end of each 6 week treatment period (Week 6 and Week 12)|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug, who used nitroglycerin.||mL/min||95% Confidence Interval|Least Squares Mean
666005|NCT01763996|Secondary|Change in Coronary Flow Velocity From Rest to IHG Exercise at the End of the Administration of Febuxostat and Placebo|Coronary flow velocity was measured by MRI at rest and during sustained isometric (static) handgrip exercise. Data at the end of each treatment period was combined for the febuxostat and the placebo arms. A positive change from Baseline indicates improvement.|Baseline and at the end of each 6 week treatment period (Week 6 and Week 12)|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug, with data available.||cm/second||95% Confidence Interval|Least Squares Mean
666006|NCT01763996|Secondary|Change in Coronary Artery Cross-Sectional Area From Rest to IHG Exercise at the End of the Administration of Febuxostat and Placebo|Coronary artery cross-sectional area was measured by MRI at rest and during sustained isometric (static) handgrip exercise. Data at the end of each treatment period was combined for the febuxostat and the placebo arms. A positive change from Baseline indicates improvement.|Baseline and at the end of each 6 week treatment period (Week 6 and Week 12)|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug, with data available.||mm^2||95% Confidence Interval|Least Squares Mean
666007|NCT01763996|Primary|Change in Coronary Artery Flow From Rest to Isometric Handgrip (IHG) Exercise at the End of the Administration of Febuxostat and Placebo|Coronary artery flow was measured using magnetic resonance imaging (MRI) at rest and during sustained isometric (static) handgrip exercises. Data at the end of each treatment period was combined for the febuxostat and the placebo arms. A positive change from Baseline indicates improvement.|Baseline and at the end of each 6 week treatment period (Week 6 and Week 12)|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug, with data available.||mL/min||95% Confidence Interval|Least Squares Mean
666008|NCT01763918|Secondary|Percent Change From Baseline in VLDL-C at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
666009|NCT01763918|Secondary|Percent Change From Baseline in Very Low-Density Lipoprotein Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
666010|NCT01763918|Secondary|Percent Change From Baseline in HDL-C at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
666011|NCT01763918|Secondary|Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
666012|NCT01763918|Secondary|Percent Change From Baseline in Triglycerides at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
666013|NCT01763918|Secondary|Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
666014|NCT01763918|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
666015|NCT01763918|Secondary|Percent Change From Baseline in Lipoprotein (a) at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
666016|NCT01763918|Secondary|Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
666017|NCT01763918|Secondary|Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
666018|NCT01763918|Secondary|Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
666019|NCT01763918|Secondary|Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
666020|NCT01763918|Secondary|Percent Change From Baseline in Apolipoprotein B at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
666021|NCT01763918|Secondary|Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
666022|NCT01763918|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
666023|NCT01763918|Secondary|Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
666024|NCT01763918|Secondary|Percentage of Participants With LDL-C < 70 mg/dL (1.8 mmol/L) at Week 12||Week 12|Full analysis set||percentage of participants||95% Confidence Interval|Number
666025|NCT01763918|Secondary|Percentage of Participants With Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL (1.8 mmol/L)||Weeks 10 and 12|Full analysis set||percentage of participants||95% Confidence Interval|Number
666026|NCT01763918|Secondary|Change From Baseline in LDL-C at Week 12||Baseline and Week 12|Full analysis set||mg/dL||Standard Error|Least Squares Mean
666051|NCT01763905|Primary|Percent Change From Baseline in LDL-C at Week 12||Baseline and Week 12|Full analysis set (all randomized participants who received at least 1 dose of investigational product (subcutaneously or orally)) with available data (no imputation was performed).||percent change||Standard Error|Least Squares Mean
666052|NCT01763866|Secondary|Percent Change From Baseline in HDL-C at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
666053|NCT01763866|Secondary|Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
666054|NCT01763866|Secondary|Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
666055|NCT01763866|Secondary|Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
666056|NCT01763866|Secondary|Percent Change From Baseline in Triglycerides at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
666057|NCT01763866|Secondary|Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
666058|NCT01763866|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
666059|NCT01763866|Secondary|Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
666060|NCT01763866|Secondary|Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12||Week 12|Full analysis set||percentage of participants||95% Confidence Interval|Number
666061|NCT01763866|Secondary|Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL||Weeks 10 and 12|Full analysis set||percentage of participants||95% Confidence Interval|Number
666062|NCT01763866|Secondary|Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
666063|NCT01763866|Secondary|Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
666064|NCT01763866|Secondary|Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
666065|NCT01763866|Secondary|Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
666066|NCT01763866|Secondary|Percent Change From Baseline in Apolipoprotein B at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
666067|NCT01763866|Secondary|Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
666068|NCT01763866|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
666069|NCT01763866|Secondary|Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
666070|NCT01763866|Secondary|Change From Baseline in LDL-C at Week 12||Baseline and Week 12|Full analysis set||mg/dL||Standard Error|Least Squares Mean
666071|NCT01763866|Secondary|Change From Baseline in LDL-C at at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||mg/dL||Standard Error|Least Squares Mean
666072|NCT01763866|Primary|Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
666073|NCT01763866|Primary|Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
666074|NCT01763827|Secondary|Percent Change From Baseline in HDL-C at Week 12||Baseline and Week 12|Full analysis set||percent change||Inter-Quartile Range|Median
666075|NCT01763827|Secondary|Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Inter-Quartile Range|Median
666076|NCT01763827|Secondary|Percent Change From Baseline in VLDL-C at Week 12||Baseline and Week 12|Ful analysis set||percent change||Inter-Quartile Range|Median
666077|NCT01763827|Secondary|Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Inter-Quartile Range|Median
666078|NCT01763827|Secondary|Percent Change From Baseline in Triglycerides at Week 12||Baseline and Week 12|Full analysis set||percent change||Inter-Quartile Range|Median
666079|NCT01763827|Secondary|Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Inter-Quartile Range|Median
666080|NCT01763827|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 12||Baseline and Week 12|Full analysis set||percent change||Inter-Quartile Range|Median
666081|NCT01763827|Secondary|Percent Change From Baseline in Lipoprotein (a) at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Inter-Quartile Range|Median
666082|NCT01763827|Secondary|Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
666083|NCT01763827|Secondary|Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
666084|NCT01763827|Secondary|Percent Change From Baseline in Total Cholesterol/High Density Lipoprotein-cholesterol Ratio at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
666085|NCT01763827|Secondary|Percent Change From Baseline in Total Cholesterol/High Density Lipoprotein-cholesterol Ratio at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
666096|NCT01763645|Secondary|Occurrence of Anti-bevacizumab Antibodies|Secondary outcome measure for immunogenicity assessment|Day 1 (before the drug administration), Day 15, 64 and 127|||percentage of patients|||Number
666097|NCT01763645|Secondary|Progression Rate|secondary outcome measure for efficacy evaluation|Day 127|||percentage of patients||95% Confidence Interval|Number
666098|NCT01763645|Secondary|Stabilization Rate|secondary outcome measure for efficacy evaluation|Day 127|||percentage of patients||95% Confidence Interval|Number
666099|NCT01763645|Secondary|Partial Response Rate|secondary outcome measure for efficacy evaluation|Day 127|||percentage of patients||95% Confidence Interval|Number
666100|NCT01763645|Secondary|Complete Response Rate|secondary outcome measure for efficacy evaluation|Day 127|||percentage of patients||95% Confidence Interval|Number
666101|NCT01763645|Primary|Area Under the Curve After the First Test Drug Administration|primary outcome measure for pharmacokinetics (PK) substudy|up to Day 22, after the first bevacizumab administration (time points for blood samples: 0 h 1.5 h, 3 h, 4.5 h, 6 h, 24 h, 96 h, 168 h, 336 h and 504 h)|Patients who received one dose of study drug and after 504 hours after injection had missed <= 1 blood sample collection to analyze pharmacokinetics.||(ng/ml)*hour||Inter-Quartile Range|Median
666102|NCT01763645|Primary|Overall Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Day 127|The efficacy analysis included only those patients who received at least one dose of BCD-021 or Avastin®, and in whom it was possible to assess the response to therapy.||percentage of participans||95% Confidence Interval|Number
666103|NCT01763567|Other Pre-specified|Functionality of HGMS: Alerts and Alarms - % of Hyper False Alert|Definition of % of Hyper False Alert: within 30 minutes before or after the sensor alarmed at 250 mg/dL, there is no reference blood glucose value (i-STAT) that goes above 250mg/dL . The % of hyper false alert was calculated as: total number of false events divided by total number of events from all 19 participants. NOTE: % of Hyper False Alert and % Hyper Event Correctly Detected do not necessarily add up to 100% because the denomintors are not the same.|Up to 72 hours|||percentage of all alerts|||Number
666104|NCT01763567|Other Pre-specified|Functionality of HGMS: Alerts and Alarms - % of Hypo False Alert|Definition of % of hypo false alert: within 30 minutes before or after the sensor alarmed at 70 mg/dL, there is no reference blood glucose value (i-STAT) that goes below 70 mg/dL. The % of hypo false alert was calculated as: total number of false events divided by total number of events from all 19 participants. NOTE: % of Hypo False Alert and % Hypo Event Correctly Detected do not necessarily add up to 100% because the denomintors are not the same.|Up to 72 hours|||percentage of all alerts|||Number
666105|NCT01763567|Other Pre-specified|Functionality of HGMS: Alerts and Alarms - % of Hyper Events Correctly Detected|The device alarmed within 30 minutes before or after the reference blood glucose value (i-STAT) goes above 250 mg/dL setting levels. The % of hyper events correctly detected was calculated as: total number of correct events divided by total number of events from all 19 participants.|72 hours|||percentage of total events|||Number
666106|NCT01763567|Other Pre-specified|Functionality of HGMS: Alerts and Alarms - % of Hypo Events Correctly Detected|The device alarmed within 30 minutes before or after the reference blood glucose value (i-STAT) goes below 70 mg/dL setting levels. The % of hypo events correctly detected was calculated as: total number of correct events divided by total number of events from all 19 participants.|up to 72 hours|||percentage of total events|||Number
666107|NCT01763567|Primary|Device Performance: Accuracy of HGMS|"Mean Absolute Relative Difference (MARD), calculated as the absolute difference of [(sensor glucose values - iSTAT glucose values) / iSTAT glucose values].
The portable i-STAT handheld makes patient-side testing easy:
Requires no special sample preparation or user calibration; maintenance is minimal
Weighs 18 ounces, making it portable
Patient-side testing is as easy as entering the operator and patient information into the handheld, inserting one of the several filled test cartridges, and then viewing test results:
The system prompts users step by step through the testing process
Operator and patient information can be entered via barcode scanner
Operator lockout prevents unauthorized users from performing or viewing test results
Test results are uploaded automatically when the i-STAT handheld is placed in a downloader"|up to 72 hours|To assess safety and device performance for the Hospital Glucose Managment system||percent difference||Standard Deviation|Mean
666108|NCT01763047|Primary|CLUE Overall Quality of Vision Using the Contact Lens User Experience (CLUE)TM Questionnaire|CLUE Overall Quality of Vision is assessed using the Contact Lens User Experience (CLUE)TM questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD).|8-12 days post wear|The analysis consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on each lens and strata.||units on a scale||Standard Deviation|Mean
666109|NCT01763047|Primary|Percentage of Eyes With Bulbar Conjunctival Redness Grade 3 or Higher|Bulbar Conjunctival Injection was assessed in 4 regions (Nasal, Temporal, Inferior and Superior) using an Efron Grading scale by 1 unit increments. Grade 0: Normal, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate, Grade 4:Severe. The data was dichotomized into two group subjects with grade 3 or higher Conjunctival injection, and those subjects with less than Grade 3 for the maximum grade of all 4 regions.|8-12 days post wear|The Analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes for each lens and strata.||Percentage of Subject Eyes|Participants||Number
666110|NCT01763047|Primary|Percentage of Eyes With Limbal Conjunctival Redness Grade 3 or Higher|The Limbus refers to the 1 to 2mm wide zone of conjunctiva and underlying tissue adjacent to where the cornea joins the sclera. Limbal Conjuctival Redness was graded in 4 regions (Nasal, Temporal, Inferior and Superior) using the Efron Grading Scale in 1 unit increments. Grade 0: Normal, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate, Grade 4: Severe. The data was dichotomized into two group subjects with grade 3 or higher Limbal Conjuctival Redness, and those subjects with less than Grade 3 for the maximum grade of all 4 regions.|8-12 days post wear|The Analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes for each lens and strata.||Percentage of Subject Eyes|Participants||Number
666111|NCT01763047|Primary|Percentage of Eyes With Corneal Staining Grade 3 or Higher|Corneal staining was evaluated in 5 corneal regions (Central, Inferior, Nasal, Temporal and Superior) using Sodium Fluorescein strips. The Fluorescien strip was lightly placed on the subject’s inferior palpebral conjunctiva. The corneal Staining was graded using the scale Grade 0: No Staining, Grade 1: Trace(Minimal superficial staining or stippling), Grade 2: Mild (Regional or diffuse punctate staining), Grade 3:Moderate(Significant dense coalesced staining, corneal abrasion or foreign body tracks.), Grade 4 Severe(Severe abrasions greater than 2 mm in diameter, ulcerations, epithelial loss, or full thickness abrasion.). The data was dichotomized into two group subjects with grade 3 or higher and those subjects with less than Grade 3 for the maximum grade of corneal staining across all 5 regions.|8-12 days post wear|The analysis population consists of subjects that completed all study visits without a major protocol deviation.The analysis was conducted on subject eyes for each lens and strata.||Percentage of Subject Eyes|Participants||Number
666112|NCT01763047|Primary|Binocular Near Visual Acuity (logMAR)|Near time controlled LogMAR Visual Acuity was carried out binocularly using High lumiance and High Contrast, at 40cm under 250 cd/m^2. The test was presented under the condition High Luminance (250cd/m^2) High Contrast (90%).|8-12 days post wear|The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on each lens and strata.||LogMAR||Standard Deviation|Mean
666113|NCT01763047|Primary|Binocular Distance Visual Acuity (LogMAR)|Distance time controlled LogMAR Visual Acuity was carried out binocularly with high luminance and high contrast, at 4m under 250 cd/m^2. The test was presented under the condition High luminance (250 cd/m^2) High Contrast (90%)|8-12 days post wear|The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on each lens and strata.||LogMAR||Standard Deviation|Mean
666114|NCT01762982|Secondary|Skin Irritation Scores at 72 Hours|Irritation potential of the treatments was assessed by proportion of the irritation scores by a trained dermatologist. Skin Irritation reaction was categorized as: 0=No visible reaction; 1= Weak Erythema (Redness); 2=Erythema, Infiltration, Papule; 3= Erythema, Edema, Papule, Blister; 4=Erythema, Edema, Extreme Blistering. For the product to be deemed as non-irritant to skin, requirements were proportion of score of 2 should not be more than 1 out of 15 participants and no cases of score of 3 or 4.|Baseline to 72 hours following first product application|ITT population: All randomized participants who received the study treatments at baseline and had at least one post baseline skin irritation scoring assessment. Missing data was not imputed.||Number of participants|||Number
666115|NCT01762982|Secondary|Skin Irritation Scores at 48 Hours|Irritation potential of the treatments was assessed by proportion of the irritation scores by a trained dermatologist. Skin Irritation reaction was categorized as: 0=No visible reaction; 1= Weak Erythema (Redness); 2=Erythema, Infiltration, Papule; 3= Erythema, Edema, Papule, Blister; 4=Erythema, Edema, Extreme Blistering. For the product to be deemed as non-irritant to skin, requirements were proportion of score of 2 should not be more than 1 out of 15 participants and no cases of score of 3 or 4.|Baseline to 48 hours following first product application|ITT population: All randomized participants who received the study treatments at baseline and had at least one post baseline skin irritation scoring assessment. Missing data was not imputed.||Number of participants|||Number
666116|NCT01762982|Primary|Proportion of Participants With Skin Irritation Scores at 72 Hours|Irritation potential of the treatments was assessed by proportion of the irritation scores by a trained dermatologist. Skin Irritation reaction was categorized as: 0=No visible reaction; 1= Weak Erythema (Redness); 2=Erythema, Infiltration, Papule; 3= Erythema, Edema, Papule, Blister; 4=Erythema, Edema, Extreme Blistering. For the product to be deemed as non-irritant to skin, requirements were proportion of score of 2 should not be more than 1 out of 15 participants and no cases of score of 3 or 4.|Baseline to 72 hours following first product application|ITT population: All randomized participants who received the study treatments at baseline and had at least one post baseline skin irritation scoring assessment. Missing data was not imputed.||Percentage of participants|||Number
666117|NCT01762982|Primary|Proportion of Participants With Skin Irritation Scores at 48 Hours|Irritation potential of the treatments was assessed by proportion of the irritation scores by a trained dermatologist. Skin Irritation reaction was categorized as: 0=No visible reaction; 1= Weak Erythema (Redness); 2=Erythema, Infiltration, Papule; 3= Erythema, Edema, Papule, Blister; 4=Erythema, Edema, Extreme Blistering. For the product to be deemed as non-irritant to skin, requirements were proportion of score of 2 should not be more than 1 out of 15 participants and no cases of score of 3 or 4.|Baseline to 48 hours following first product application|ITT population: All randomized participants who received the study treatments at baseline and had at least one post baseline skin irritation scoring assessment. Missing data was not imputed.||Percentage of participants|||Number
666118|NCT01762982|Secondary|Skin Irritation Scores at 24 Hours|Irritation potential of the treatments was assessed by proportion of the irritation scores by a trained dermatologist. Skin Irritation reaction was categorized as: 0=No visible reaction; 1= Weak Erythema (Redness); 2=Erythema, Infiltration, Papule; 3= Erythema, Edema, Papule, Blister; 4=Erythema, Edema, Extreme Blistering. For the product to be deemed as non-irritant to skin, requirements were proportion of score of 2 should not be more than 1 out of 15 participants and no cases of score of 3 or 4.|Baseline to 24 hours following product application|ITT population: All randomized participants who received the study treatments at baseline and had at least one post baseline skin irritation scoring assessment. Missing data was not imputed.||Number of participants|||Number
666119|NCT01762982|Primary|Proportion of Participants With Skin Irritation Scores at 24 Hours|Irritation potential of the treatments was assessed by proportion of the irritation scores by a trained dermatologist. Skin Irritation reaction was categorized as: 0=No visible reaction; 1= Weak Erythema (Redness); 2=Erythema, Infiltration, Papule; 3= Erythema, Edema, Papule, Blister; 4=Erythema, Edema, Extreme Blistering. For the product to be deemed as non-irritant to skin, requirements were proportion of score of 2 should not be more than 1 out of 15 participants and no cases of score of 3 or 4.|Baseline to 24 hours following product application|Intention to Treat (ITT) population: All randomized participants who received the study treatments at baseline and had at least one post baseline skin irritation scoring assessment.||Percentage of participants|||Number
666181|NCT01762345|Other Pre-specified|Percentage of Responders for SUI Episodes||from the 14-day baseline period to the last 7 days of 14-day device usage period|"Intent-to-Treat (ITT) population. The Number of Participants Analyzed is the number subjects with available (non-missing) data in week 2"||percentage of subjects|||Number
666120|NCT01762904|Secondary|Detect Presence of Allergy or Skin Reaction by the Antiseptic Application|"135 units of measurement to test two antiseptics and two controls. Principal unit of measurement: four determinations of bacterial counts in a subject for antiseptics and controls to test each of the application sites.
All volunteers was provided with a neutral soap without antiseptics for use of two weeks. 2% chlorhexidine in 70% isopropyl alcohol and 1% triclosan in 70% isopropyl alcohol, Deionized water redistilled and Scrub the skin without prior application of any substance was tested. We prepared four skin's areas of 25 cm2, two in each forearm. The solution remained on the skin for 60s, 3h and 24h.
Presence of allergy or any skin reaction at 24 hours after the antiseptic application."|24 hours|||participants||Inter-Quartile Range|Median
666121|NCT01762904|Primary|Evaluate the Effect on the Skin Flora Application Process of Antiseptics by Sterile Swab|"135 units of measurement to test two controls. Principal unit of measurement: four determinations of bacterial counts in a subject for antiseptics and controls to test each of the application sites.
All volunteers was provided with a neutral soap without antiseptics for use of two weeks. Deionized water redistilled (Control 2: Control with scrub) and Scrub the skin without prior application of any substance (Control1: Control without scrub) was tested. Were prepared two skin's areas of 25 cm2 randomly selected. The solution remained on the skin for 60s, 3h and 24h.
Cultures was taken with a scrub-cup of 5 cm2 pressed over the skin, added a 3 mL of culture broth. The skin was scrub with a sterile rubber policeman for 1 minute and the procedure conducted once again. Both aliquots came together in a sterile tube, a sample of 50 microliters were spread in a plate containing a neutralizing agar and were incubated at 35°C for 24 h."|24 hrs|||(CFU/cm2)||Inter-Quartile Range|Median
666122|NCT01762904|Primary|Evaluate the Residual Effect of Triclosan 1% / Isopropyl Alcohol 70% Administered Topically.|"135 determinations to test 1% triclosan in 70% isopropyl alcohol.
All volunteers was provided with a neutral soap without antiseptics for use of two weeks. 1% triclosan in 70% isopropyl alcohol was tested. Were prepared the skin area of 25 cm2 randomly selected. The solution remained on the skin for 60s, 3h and 24h, everyone on different days.
Cultures was taken with a scrub-cup of 5 cm2 pressed over the skin, added a 3 mL of culture broth. The skin was scrub with a sterile rubber policeman for 1 minute and the procedure conducted once again. Both aliquots came together in a sterile tube, a sample of 50 microliters were spread in a plate containing a neutralizing agar and were incubated at 35°C for 24 h."|24 hours|||(CFU/cm2)||Inter-Quartile Range|Median
666123|NCT01762904|Primary|Evaluate the Residual Effect of Chlorhexidine 2% / Isopropyl Alcohol 70% Administered Topically|"135 determinations to evaluate residual effect of 2% chlorhexidine in 70% isopropyl alcohol.
All volunteers was provided with a neutral soap without antiseptics for use of two weeks. 2% chlorhexidine in 70% isopropyl alcohol was tested. Were prepared the skin area of 25 cm2 randomly selected. The solution remained on the skin for 60s, 3h and 24h, everyone on different days.
Cultures was taken with a scrub-cup of 5 cm2 pressed over the skin, added a 3 mL of culture broth. The skin was scrub with a sterile rubber policeman for 1 minute and the procedure conducted once again. Both aliquots came together in a sterile tube, a sample of 50 microliters were spread in a plate containing a neutralizing agar and were incubated at 35°C for 24 h."|24 hours|||(CFU/cm2)||Inter-Quartile Range|Median
666124|NCT01762800|Secondary|Number of Participants in Each Treatment Efficacy Grade Evaluated by Physician|Physician evaluated treatment efficacy by using the following grades: significantly improved (SII), moderately improved (MOI), mildly improved (MII), no change (NC), mildly worse (MIW), moderately worse (MOW), and significantly worse (SIW). Treatment efficacy was assessed at Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 8), Visit 6 (Week 12), Visit 7 (Week 16), and Visit 8 (Week 24).|24 weeks|mITT population||Participants|||Number
666125|NCT01762800|Secondary|Number of Participants in Each Treatment Efficacy Grade Evaluated by Participants|Participants evaluated treatment efficacy by using the following grades: significantly improved (SII), moderately improved (MOI), mildly improved (MII), no change (NC), mildly worse (MIW), moderately worse (MOW), and significantly worse (SIW). Treatment efficacy was assessed at Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 8), Visit 6 (Week 12), Visit 7 (Week 16), and Visit 8 (Week 24).|Up to 24 weeks|mITT population||Participants|||Number
666126|NCT01762800|Secondary|Percentage of Participants Who Dropped Out|The percentage of participants who were withdrawn from the study.|24 weeks|All Subjects population: all participants who were enrolled into the study and whose data obtained at screening (visit1) was not missing and demography data was available.||Percentage of participants|||Number
666127|NCT01762800|Secondary|Percentage of Participants Who Required Additional Treatment to TRIPLE Therapy|The percentage of participants who required additional treatment to TRIPLE therapy is defined as number of participants who took additional medicine or therapy in TRIPLE therapy divided by number of participants who switch to TRIPLE therapy multiplied by 100.|24 weeks|mITT population||Percentage of participants||95% Confidence Interval|Number
666128|NCT01762800|Secondary|Percentage of Participants Who Stepped Down From TRIPLE Therapy to Initial Randomized Treatment|The percentage of participants who stepped down from TRIPLE therapy to initial randomized treatment was calculated as number of participants who step-down from TRIPLE therapy divided by number of participants who switch to TRIPLE therapy and then multiplied by 100.|24 weeks|mITT population||Percentage of participants||95% Confidence Interval|Number
666129|NCT01762800|Secondary|Percentage of Participants Who Used Relief Medication (Salbutamol)|Each evening participants recorded the number of occasions in the last 24 hours when they used their salbutamol for symptomatic relief of COPD symptoms. The percentage of participants who used relief medication in the study are presented.|24 weeks|mITT population||Percentage of participants|||Number
666130|NCT01762800|Secondary|Change From Baseline in FEV1|FEV1 is defined as the volume of air forcefully expelled from the lungs in one second. Baseline was a value at Visit 2 (randomization). Change from Baseline was calculated as specific timepoint value minus Visit 2 value. FEV1 was assessed at Visit 2 (Baseline), Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 8), Visit 6 (Week 12), Visit 7 (Week 16), and Visit 8 (Week 24).|Baseline (Visit 2) and up to 24 weeks|mITT population. Only those participants available at the specified time points (represented by n=X, X, X, X in the category titles) were analyzed.||Liters||Standard Deviation|Mean
666182|NCT01762345|Other Pre-specified|Percentage of Responders for Pad Weight Gain||from the 14-day baseline period to the last 7 days of 14-day device usage period|"Intent-to-Treat (ITT) population. The Number of Participants Analyzed is the number subjects with available (non-missing) data in week 2"||percentage of subjects|||Number
666131|NCT01762800|Secondary|Forced Expiratory Volume in One Second (FEV1)|FEV1 is defined as the volume of air forcefully expelled from the lungs in one second. At Screening (Visit 1) spirometric assessments were conducted before (Visit 1A) and 30 to 60 minutes after a bronchodilator challenge (400 µg of salbutamol) (Visit 1B). FEV1 during each visit are presented. FEV1 was assessed at Visit 1A (Screening), Visit 1B (Screening), Visit 2 (Baseline), Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 8), Visit 6 (Week 12), Visit 7 (Week 16), and Visit 8 (Week 24).|Up to 24 weeks|mITT population. Only those participants available at the specified time points (represented by n=X, X, X, X in the category titles) were analyzed.||Liters||Standard Deviation|Mean
666132|NCT01762800|Secondary|Change From Baseline in CAT Total Score|Participants were assessed for COPD symptoms by means of CAT at each Visit. This assessment was performed prior to the spirometry testing. A CAT total score of less than 10 represents best health status and greater than 15 represents worst health status. Baseline was the value at Visit 2 (randomization). Change from Baseline was calculated as specific timepoint value minus Visit 2 value. Scores were assessed at Visit 2 (Baseline), Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 8), Visit 6 (Week 12), Visit 7 (Week 16), and Visit 8 (Week 24). Scores range from 0 to 40, high value in score indicate worse outcome.|Baseline and up to 24 weeks|mITT population. Only those participants available at the specified time points (represented by n=X, X, X, X in the category titles) were analyzed.||Scores on a scale||Standard Deviation|Mean
666133|NCT01762800|Secondary|Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) Total Score|Participants were assessed for COPD symptoms by means of CAT at each Visit. This assessment was performed prior to the spirometry testing. A CAT total score of less than 10 represents best health status and greater than 15 represents worst health status. Scores were assessed at Visit 1 (Screening), Visit 2 (Baseline), Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 8), Visit 6 (Week 12), Visit 7 (Week 16), and Visit 8 (Week 24). Scores range from 0 to 40, high value in score indicate worse outcome.|24 weeks|mITT population. Only those participants available at the specified time points (represented by n=X, X, X, X in the category titles) were analyzed.||Scores on a scale||Standard Deviation|Mean
666134|NCT01762800|Secondary|Comparison of Number of Exacerbations Between Two Detection Methods: EXACT and Physician Diagnosis|The comparison of number of exacerbation between two detection methods EXACT and physician diagnosis: number of exacerbations detected by EXACT and number of exacerbations judged by physician.|24 weeks|mITT population||Number of exacerbations||Standard Deviation|Mean
666135|NCT01762800|Secondary|E-RS Subscale Score|The E-RS total score is an 11-item patient questionnaire, which provides information specific to respiratory symptoms-severity of respiratory symptoms overall and severity of breathlessness, cough and sputum, and chest symptoms. The E-RS subscale scores for respiratory symptoms (RS)-breathlessness (RS-BRL), RS-cough and sputum (RS-CSP), and RS-chest symptoms (RS-CSY) are presented. Scores were assessed at Baseline, Week 1-4, Week 5-8, Week 9-12, Week 13-16, Week 17-20 and at Week 21-24. Daily EXACT total score is obtained as total score of 14 items from diary. Daily E-RS total score as 11 items and Daily E-RS subscale scores are subset of E-RS total score. Mean EXACT total score is mean value of daily EXACT total score within subject by every 4 weeks(Week1-4, Week5-8, Week9-12, Week13-16, Week17-20, Week21-24). Same calculation of mean values are applied to E-RS total and E-RS subscale scores. RS total scores range from 0 to 40, high value in score indicate worse outcome.|24 weeks|mITT population. Only those participants available at the specified time points (represented by n=X, X, X, X in the category titles) were analyzed.||Scores on a scale||Standard Deviation|Mean
666136|NCT01762800|Secondary|EXACT Respiratory Symptoms (E-RS) Total Score|"The E-RS total score is an 11-item patient questionnaire, which provides information specific to respiratory symptoms-severity of respiratory symptoms overall and severity of breathlessness, cough and sputum, and chest symptoms. Scores were assessed at Baseline, Week 1-4, Week 5-8, Week 9-12, Week 13-16, Week 17-20 and at Week 21-24. Daily EXACT total score is obtained as total score of 14 items from diary. Daily E-RS total score as 11 items and Daily E-RS subscale scores are subset of E-RS total score.
Mean EXACT total score is mean value of daily EXACT total score within subject by every 4 weeks(Week1-4, Week5-8, Week9-12, Week13-16, Week17-20, Week21-24). Same calculation of mean values are applied to E-RS total and E-RS subscale scores. Scores range from 0-100, high value in score indicate worse outcome."|Baseline and up to 24 weeks|mITT population. Only those participants available at the specified time points (represented by n=X, X, X, X in the category titles) were analyzed.||Scores on a scale||Standard Deviation|Mean
666137|NCT01762800|Secondary|EXACT Total Score.|"EXACT is a 14-item patient questionnaire used as a measure of respiratory symptoms (reported as units on a 0 [best health status] to 100 [worst possible status] scale). Scores were assessed at Baseline, Week 1-4, Week 5-8, Week 9-12, Week 13-16, Week 17-20 and Week 21-24. Daily EXACT total score is obtained as total score of 14 items from diary. Daily E-RS total score as 11 items and Daily E-RS subscale scores are subset of E-RS total score.
Mean EXACT total score is mean value of daily EXACT total score within subject by every 4 weeks(Week1-4, Week5-8, Week9-12, Week13-16, Week17-20, Week21-24). Same calculation of mean values are applied to E-RS total and E-RS subscale scores."|Baseline and up to 24 weeks|mITT population. Only those participants available at the specified time points (represented by n=X, X, X, X in the category titles) were analyzed.||Scores on a scale||Standard Deviation|Mean
666138|NCT01762800|Secondary|Time to First Exacerbation by EXAcerbations of Chronic Pulmonary Disease Tool (EXACT)|The EXAcerbations of Chronic pulmonary disease Tool (EXACT) is a 14-item patient-reported outcome (PRO) daily diary used to quantify and measure exacerbations of chronic obstructive pulmonary disease (COPD). Reported as units on a 0 [best health status] to 100 [worst possible status] scale). The day of detection of first exacerbation in any participant in each arm by EXACT.|24 weeks|||Days|||Number
666139|NCT01762800|Secondary|Time to First Exacerbation by Physician's Diagnosis|The day of detection of first exacerbation in any participant in each arm as diagnosed by physician. Exacerbation is defined primarily by physician’s judgment. Date of randomisation will be start point and timing of exacerbation (first exacerbation if there are more than one) will be event. For subjects without exacerbation, last day of study or follow up period is regarded as censor.|24 weeks|mITT population||Days|||Number
666140|NCT01762800|Secondary|Time to First Switching to TRIPLE Therapy|The day of first switch to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) for the first switching participant in each arm.|24 weeks|mITT population||Days|||Number
666267|NCT01760889|Secondary|Change From Baseline in Clinical Evaluation of Harmful Behavior (CEHB) Scale at 26 Weeks||Baseline and 26 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
666141|NCT01762800|Secondary|Continuation Percentage of Participants Managed by Randomized Treatment Plus TRIPLE Therapy|The randomized treatment could be switched to TRIPLE therapy in the case that chronic obstructive pulmonary disease (COPD) was not controlled by the randomized treatment. Participants on TRIPLE therapy received SAL/FLU 50/250 µg BID plus TIO 18 µg QD together. Continuation TRIPLE proportion is defined as [(number of subjects who switched to TRIPLE) - (number of subjects who stepped down)/ number of evaluable population]*100. Randomised treatment continuation proportion is calculated by a formula: (100 - switch proportion).|24 weeks|mITT population||Percentage of participants||95% Confidence Interval|Number
666142|NCT01762800|Secondary|Percentage of Participants Managed by TRIPLE Therapy|Percentage of participants managed by TRIPLE therapy was calculated as [(number of participants who switched to TRIPLE therapy) - (number of participants who stepped down)/ number of evaluable population]*100|24 weeks|mITT population||Percentage of participants||95% Confidence Interval|Number
666143|NCT01762800|Secondary|Percentage of Participants Who Switched to TRIPLE Therapy|Switched to TRIPLE therapy is defined as: 1. Date of switch: when SAL/FLU or TIO was administered additionally to randomised treatment. 2. Date of randomisation was a start point and timing of switching (first switch if there are more than once) to TRIPLE was event. For participants without switching, last day of study or follow up period was regarded as censored. Percentage of participants who switched to TRIPLE therapy was calculated as: number of participants who switched to TRIPLE therapy divided by number of evaluable population and then multiplied by 100.|24 weeks|mITT population||Percentage of participants||95% Confidence Interval|Number
666144|NCT01762800|Primary|Percentage of Participants Who Were Able to Remain on the Randomized Treatment|The randomized treatment could be switched to TRIPLE therapy in the case that chronic obstructive pulmonary disease (COPD) is not controlled by the randomized treatment. Participants on TRIPLE therapy received SAL/FLU 50/250 µg BID plus TIO 18 µg QD together. The percentage of participants who were able to remain on the randomized treatment was calculated by the following formula: 100 minus percentage of participants who switched over to TRIPLE therapy.|24 weeks|Modified Intent-to-Treat (mITT) population: randomized participants who received at least a single dose of the investigational product.||Percentage of participants||95% Confidence Interval|Number
666145|NCT01762761|Secondary|Pharmacodynamic Parameter-Maturation Rate of Platelet Precursors (KOUT)|The Pharmacokinetic/ Pharmacodynamic relationship between eltrombopag concentrations and the platelet response was described by a four-compartment life span model, representing one precursor production compartment, two transit/maturation compartments and one blood platelet compartment. The estimate of KOUT was fixed to 0.0253 /hr.|From the start of study until 24 hours post-dose of Week 2 Visit of Stage 2|PK/PD Population||1/ hr|||Number
666146|NCT01762761|Secondary|Pharmacodynamic Parameter- Production Rate of Platelet Precursors (KIN)|The Pharmacokinetic/ Pharmacodynamic relationship between eltrombopag concentrations and the platelet response was described by a four-compartment life span model, representing one precursor production compartment, two transit/maturation compartments and one blood platelet compartment. The estimate of KIN was fixed to 1.43x10^9/L.hr.|From the start of study until 24 hours post-dose of Week 2 Visit of Stage 2|PK/PD Population||1 x 10^9/L.hr|||Number
666147|NCT01762761|Secondary|Pharmacodynamic Parameter-Linear Proportionality Constant of Drug Effect (SLOP): the Proportional Increase of Platelet Production Rate With Each 1-μg/mL Increase in Eltrombopag Plasma Concentration|The Pharmacokinetic/ Pharmacodynamic relationship between eltrombopag concentrations and the platelet response was described by a four-compartment life span model, representing one precursor production compartment, two transit/maturation compartments and one blood platelet compartment.|From the start of study until 24 hours post-dose of Week 2 Visit of Stage 2|PK/PD Population||Milliliter/microgram||95% Confidence Interval|Geometric Mean
666148|NCT01762761|Secondary|Percentage of Participants Estimated as Responders to Eltrombopag by the Pharmacokinetic/ Pharmacodynamic Model|Responders are participants whose SLOP estimates are larger than zero. The Pharmacokinetic/ Pharmacodynamic relationship between eltrombopag concentrations and the platelet response was described by a four-compartment life span model, representing one precursor production compartment, two transit/maturation compartments and one blood platelet compartment.|From the start of study until 24 hours post-dose of Week 2 Visit of Stage 2|PK/PD Population: all participants with evaluable dosing, actual sampling time, and platelet count data.||Percentage of participants|||Number
666149|NCT01762761|Secondary|Post-hoc Estimates of Maximum Observed Concentration (Cmax) for Eltrombopag After 50 mg Once Daily Dose of Eltrombopag|Cmax is defined as maximum observed concentration after 50 mg once daily dose of eltrombopag. PK analysis was conducted using a population approach with non-linear mixed effects modeling methods. Post-hoc estimates of steady-state eltrombopag Cmax was determined based on the final PK model. Individual PK parameters were derived from the final PK model by an empirical Bayes estimation. Summary of steady-state Cmax of eltrombopag .is presented here.|From the start of study until 24 hours post-dose of Week 2 Visit of Stage 2|PK Population||Nanogram/ Milliliter (ng/mL)||95% Confidence Interval|Geometric Mean
666150|NCT01762761|Secondary|Post-hoc Estimates of Plasma Eltrombopag Area Under the Concentration-time Curve Over a Dosing Interval (AUC[0-tau]) After 50 mg Once Daily Dose of Eltrombopag|AUC[0-tau] is defined as area under the concentration-time curve over a dosing interval (24 hr) of Eltrombopag atsteady-state after 50 mg once daily dose of eltrombopag. PK analysis was conducted using a population approach with non-linear mixed effects modeling methods. Post-hoc estimates of steady-state eltrombopag was determined based on the final PK model. Individual PK parameters were derived from the final PK model by an empirical Bayes estimation. Summary of steady-state AUC(0-tau) of eltrombopag is presented here.|From the start of study until 24 hours post-dose of Week 2 Visit of Stage 2|PK Population||Microgram* hour per milliliter(μg.hr/mL)||95% Confidence Interval|Geometric Mean
666151|NCT01762761|Secondary|Pharmacokinetic Assessments for Eltrombopag for Absorption Lag Time (ALAG)|Absorption lag time (ALAG) is defined as the time taken for a drug to appear in the systemic circulation following administration. PK assessments were made with one group of serial sampling [Samples collected at pre-dose and 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 24 hr post-dose] and one group of sparse assessment [Samples collected at pre-dose, between 2 to 4 hrs and 5 to 8 hrs post-dose]. Pre-dose samples were collected within 2 hrs prior to dosing, all other samples were collected within 10 min for samples collected between 1 and 6 hr and within 30 min for samples collected at 8 and 24 hr. PK analysis was conducted using a population approach with non-linear mixed effects modeling methods. Point estimates of population PK parameter is presented.|From the start of study until 24 hours post-dose of Week 2 Visit of Stage 2|PK Population||Hour||95% Confidence Interval|Geometric Mean
666152|NCT01762761|Secondary|Pharmacokinetic Assessments for Eltrombopag for Absorption Rate Constant (Ka)|Ka is defined as the absorption rate constant. PK assessments were made with one group of serial sampling [Samples collected at pre-dose and 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 24 hr post-dose] and one group of sparse assessment [Samples collected at pre-dose, between 2 to 4 hr and 5 to 8 hr post-dose]. Pre-dose samples were collected within 2 hrs prior to dosing, all other samples were collected within 10 min for samples collected between 1 and 6 hrs and within 30 mins for samples collected at 8 and 24 hr. PK analysis was conducted using a population approach with non-linear mixed effects modeling methods. Point estimates of population PK parameter is presented.|From the start of study until 24 hours post-dose of Week 2 Visit of Stage 2|PK Population||Per hour (1/hr)||95% Confidence Interval|Geometric Mean
666153|NCT01762761|Secondary|Pharmacokinetic Assessments for Eltrombopag for Apparent Clearance (CL/F), Apparent Inter-compartmental Clearance (Q/F)|CL/F is defined as the apparent oral clearance from plasma and Q/F is defined as apparent intercompartmental clearance. PK assessments were made with one group of serial sampling [Samples collected at pre-dose and 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 24 hr post-dose] and one group of sparse assessment [Samples collected at pre-dose, between 2 to 4 hr and 5 to 8 hr post-dose]. Pre-dose samples were collected within 2 hr prior to dosing, all other samples were collected within 10 min for samples collected between 1 and 6 hr and within 30 min for samples collected at 8 and 24 hr. PK analysis was conducted using a population approach with non-linear mixed effects modeling methods. Point estimates of population PK parameters are presented.|From the start of study until 24 hours post-dose of Week 2 Visit of Stage 2|PK Population||Liters per hour(L/hr)||95% Confidence Interval|Geometric Mean
666154|NCT01762761|Secondary|Pharmacokinetic (PK) Assessments for Eltrombopag for Apparent Volume of Distribution of Central Compartment (Vc/F), Apparent Volume of Distribution of Peripheral Compartment (Vp/F)|Vc/F is apparent volume of distribution of plasma (VDP) in central compartment and Vp/F is apparent VDP in peripheral compartment. PK assessments were made with one group of serial sampling [Samples collected at pre-dose and 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 24 hr post-dose] and one group of sparse assessment [Samples collected at pre-dose, between 2 to 4 hr and 5 to 8 hr post-dose]. Pre-dose samples were collected within 2 hr prior to dosing, all other samples were collected within 10 minutes(min) for samples collected between 1 and 6 hrs and within 30 mins for samples collected at 8 and 24 hr. PK analysis was conducted using a population approach with non-linear mixed effects modeling methods. Point estimates of population PK parameters are presented.|From the start of study until 24 hours post-dose of Week 2 Visit of Stage 2|PK Population: all participants with evaluable dosing, actual sampling time, and eltrombopag concentration data.||Liters||95% Confidence Interval|Geometric Mean
666155|NCT01762761|Secondary|Number of Participants With the Indicated Grading of Myelofibrosis Using Bone Marrow Biopsy at Screening|Bone marrow biopsy was performed at Screening and then obtained when clinically indicated. Whenever a peripheral blood smear confirmed the presence of immature or dysplastic cells, a bone marrow examination was performed. Myelofibrosis (MF) was graded from Grade MF-0 to MF-3 where MF-0=scattered linear reticulin with no intersections (cross-overs) corresponding to normal bone marrow; MF-1=loose network of reticulin with many intersections; especially in perivascular areas; MF-2=diffuse and dense increase in reticulin with extensive intersections, occasionally with only focal bundles of collagen and/or focal osteosclerosis; MF-3=diffuse and dense increase in reticulin with extensive intersections with coarse bundles of collagen, often associated with significant osteosclerosis.|Screening|Safety Population. Only those participants with data available at the specified time points were analyzed.||Participants|||Number
666156|NCT01762761|Secondary|Number of Participants With a Change From Baseline in Visual Acuity|Visual acuity is a measure of the spatial resolution of the visual processing system. Acuity is a measure of visual performance and is unrelated to the eyeglass prescription required to correct vision. Normal visual acuity is commonly referred to as 20/20 vision. Evaluation was done for oculus sinister (OS) for the left eye, oculus dexter (OD) for the right eye. Change from Baseline was calculated as the value at post-Baseline time point minus the value at Baseline.|From the start of study treatment (Day 1) up to the end of Week 6 of Stage 1|Safety Population||Participants|||Number
666157|NCT01762761|Secondary|Number of Participants With the Indicated 12-lead Electrocardiogram (ECG) Finding at Baseline|Resting 12-lead ECG was obtained at Baseline. Day 1 assessment was considered as Baseline; if Day 1 was not available then the Screening assessment was considered as Baseline. ECG was also obtained when there was clinical symptom that potentially related to cardiac dysfunction based on investigator’s judgement.|Baseline|Safety Population. Only those participants with data available at the specified time points were analyzed.||Particpants|||Number
666158|NCT01762761|Secondary|Change From Baseline in Pulse Rate|Pulse rate was measured at Baseline, Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6. Day 1 assessment was considered as Baseline; if Day 1 was not available then the Screening assessment was considered as Baseline. Change from Baseline was calculated as the value at post-Baseline time point minus the value at Baseline.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6|Safety Population||Beats per minute||Standard Deviation|Mean
666159|NCT01762761|Secondary|Change From Baseline in Diastolic Blood Pressure|Diastolic blood pressure was measured in sitting position at Baseline, Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6. Day 1 assessment was considered as Baseline; if Day 1 was not available then the Screening assessment was considered as Baseline. Change from Baseline was calculated as the value at post-Baseline time point minus the value at Baseline.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6|Safety Population||mm Hg||Standard Deviation|Mean
666160|NCT01762761|Secondary|Change From Baseline in Systolic Blood Pressure|Systolic blood pressure was measured in the sitting position at Baseline, Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6. Day 1 assessment was considered as Baseline; if Day 1 was not available then the Screening assessment was considered as Baseline. Change from Baseline was calculated as the value at post-Baseline time point minus the value at Baseline.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6|Safety Population||Millimeters of mercury (mm Hg)||Standard Deviation|Mean
666207|NCT01762059|Primary|Percentage of Time Blood Glucose Values Less Than 70 mg/dl (Co-primary Outcome)|"Percentage of time blood glucose values during the closed-loop control period less than 70 mg/dl determined from HemoCue capillary measurements (daytime) and GlucoScout venous measurements (nighttime) during day 1-5.
During usual care (open loop), blood sugars were not checked through GlucoScout or HemoCue (as per usual care fashion) and so were not compared to bionic pancreas (closed loop) arm"|5 days|This outcome measure was only assessed for the closed loop control period, and was not assessed during the usual care arm.||percentage of time||Standard Deviation|Mean
666161|NCT01762761|Secondary|Number of Participants With the Maximum Toxicity Grade for the Indicated Hematology Parameters|Clinical hematology parameters hemoglobin, lymphocytes, platelet count, total neutrophils, white blood cell count evaluations were performed at Baseline, at all on-therapy visits, and at Week 1, Week 2, Week 3, and Week 4 visits during the follow-up period and were summarized according to the NCI CTCAE V4.0: Grade 0, none; Grade 1, mild; Grade 2, moderate; Grade 3, severe or medically significant; Grade 4, life-threatening consequences; Grade 5, death related to AE. Day 1 assessment was considered as Baseline; if Day 1 was not available then Screening assessment is taken as Baseline. Maximum post-Baseline toxicity grade included any scheduled or unscheduled post-Baseline assessment.|From the start of study treatment (Day 1) up to the end of Week 6 of Stage 1|Safety Population. Only those participants with data available at the specified time points were analyzed.||Participants|||Number
666162|NCT01762761|Secondary|Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters|Clinical chemistry parameters aspartate amino transferase (AST), alanine amino transferase (ALT), gamma glutamyl transferase (GGT), total bilirubin, albumin, alkaline phosphatase, calcium, potassium, creatinine, glucose and sodium were evaluated at Baseline, at all on therapy visits, and at Week 1, Week 2, Week 3, and Week 4 visits during the follow-up period and were summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4 (NCI CTCAE V4.0): Grade 0, none; Grade 1, mild; Grade 2, moderate; Grade 3, severe or medically significant; Grade 4, life-threatening consequences; Grade 5, death related to AE. Day 1 assessment was considered as Baseline; if Day 1 was not available then Screening assessment is taken as Baseline. For creatinine, Baseline is defined as the average of Screening and Day 1 values if available and prior to first dose. Maximum post-Baseline toxicity grade included any scheduled or unscheduled post-Baseline assessment|From the start of study treatment (Day 1) up to the end of Week 6 of Stage 1|Safety Population. Only those participants with data available at the specified time points were analyzed.||Participants|||Number
666163|NCT01762761|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.A SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, is a congenital anomaly/birth defect or is associated with protocol specified liver injury and impaired liver function or is any protocol specific AEs.|From the start of study treatment (Day 1) up to the end of Week 8 of Stage 1|Safety Population: all randomized participants who received at least one dose of the study treatment.||Participants|||Number
666164|NCT01762761|Secondary|Number of Participants That Reduced or Discontinued Baseline Concomitant ITP Medications During Stage 2 and Stage 3|The number of participants taking concomitant ITP medications on Day 1 of Stage 1 who had a decrease in the dose or frequency of ITP medication or stopped ITP medication at any point during Stage 2 or Stage 3 will be presented. The Baseline concomitant ITP medication for Stage 2 and Stage 3 is defined as ITP medications taken prior to the first dose of investigational product of Stage 1. This study is still ongoing and this endpoint can only be analyzed when the stage 2 and stage 3 complete.|From the start of Week 1 of Stage 2 to the end of last week of Stage 3||07/2017||||
666165|NCT01762761|Secondary|Maximum Period of Time a Participant Had a Platelet Count Continuously >= 50 ×10^9/L|Maximum period of time a participant had a platelet count continously >=50 x 10^9/L was analyzed using the van Elteren stratified rank test with stratification factors including the use of ITP medication at Baseline (yes/no), splenectomy (yes/no) and Baseline platelet count <=15x10^9/L (yes/no). Complete blood count including platelet count was done at Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6.|From the start of study treatment (Day 1) up to the end of Week 6 of Stage 1|ITT Population||Weeks||Inter-Quartile Range|Median
666166|NCT01762761|Secondary|Total Duration of Time a Participant Had a Platelet Count >=50×10^9/L|Total duration of time a participant had platelet count >=50 x 10^9/L was analyzed using the van Elteren stratified rank test with stratification factors including the use of ITP medication at Baseline (yes/no), splenectomy (yes/no) and Baseline platelet count <=15x10^9/L (yes/no). Complete blood count including platelet count was done at Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6.|From the start of study treatment (Day 1) up to the end of Week 6 of Stage 1|ITT Population||Weeks||Inter-Quartile Range|Median
666167|NCT01762761|Secondary|Number of Participants With a Platelet Count >=50×10^9/L During at Least 75% of Their Platelet Count Assessments|The number of participants with a platelet count >=50×10^9/L during at least 75% of their platelet count assessments was analyzed up to the end of Week 6 of Stage 1. Logistic regression analysis was adjusted for use of ITP medication at Baseline (yes/no), splenectomy (yes/no), Baseline platelet count <=15x10^9/L (yes/no) and treatment. Complete blood count including platelet count was done at Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6.|From the start of study treatment (Day 1) up to the end of Week 6 of Stage 1|ITT Population||Participants|||Number
666168|NCT01762761|Secondary|Number of Participants Who Required Protocol-defined Rescue Treatment During the First 6 Weeks of Stage 1|Rescue treatment is defined as either a new ITP medication, an increase in dose of concomitant ITP medication from Baseline, a platelet transfusion, or a splenectomy. Logistic regression analysis was adjusted for use of ITP medication at Baseline (yes/no), splenectomy (yes/no), Baseline platelet count <=15x10^9/L (yes/no) and treatment.|From the start of study treatment (Day 1) up to the end of Week 6 of Stage 1|ITT Population||Participants|||Number
666169|NCT01762761|Secondary|Time to Response|Time to response is defined as time from the startin of treatment to the first time of achieving a platelet count >=50x10^9/L during the first 6 weeks of Stage 1. Time to response is summarized using Kaplan-Meier estimates and compared between treatment groups using a stratified log-rank test, stratifying for the use of ITP medication at Baseline (yes/no), splenectomy (yes/no), Baseline platelet count <=15x10^9/L (yes/no). The pike estimator of the treatment hazard ratio is based on the stratified log-rank test. Complete blood count including platelet count was done at Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6.|From the start of study treatment (Day 1) up to the end of Week 6 of Stage 1|ITT Population.Only those participants (par.) with a response were analyzed (3 responders out of 50 participants in the placebo group and 60 responders out of 104 participants in the Eltrombopag group for calculating the statistics of time to response analysis).||Weeks||95% Confidence Interval|Median
666308|NCT01759368|Primary|Number of HF-related Hospital Days|Number of heart failure related hospital days|From baseline until the end of the study at six months|||number of days||Standard Deviation|Mean
666170|NCT01762761|Secondary|Number of Participants With Clinically Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale|The WHO Bleeding Scale is a measure of bleeding severity with the following grades: grade 0 = no bleeding, grade 1= petechiae, grade 2= mild blood loss, grade 3 = gross blood loss, and grade 4 = debilitating blood loss. The WHO Bleeding Scale grades were dichotomized into the following categories: no clinically significant bleeding = Grade 0 to 1; clinically significant bleeding = Grade 2 to 4. Generalized linear mixed model with a Logit canonical link function for repeated binary data, allowing for Baseline dichotomized WHO bleeding grade, use of ITP medication at Baseline (yes/no), splenectomy (yes/no), Baseline platelet count <=15×10^9/L (yes/no) and treatment as fixed effects, and the participant was treated as a random effect.|From the start of study treatment (Day 1) up to the end of Week 6 of Stage 1|ITT Population||Participants|||Number
666171|NCT01762761|Secondary|Number of Participants With Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale|The WHO Bleeding Scale is a measure of bleeding severity with the following grades: grade 0 = no bleeding, grade 1= petechiae, grade 2= mild blood loss, grade 3 = gross blood loss, and grade 4 = debilitating blood loss. The WHO Bleeding Scale were dichotomized to indicate no bleeding vs bleeding, i.e. 0=grade 0 and 1=grades 1, 2, 3 or 4. Generalized linear mixed model was applied with a Logit canonical link function for repeated binary data, allowing for Baseline dichotomized WHO bleeding grade, use of ITP medication at Baseline (yes/no), splenectomy (yes/no), Baseline platelet count <=15×10^9/L (yes/no) and treatment as fixed effects, and the participant was treated as a random effect. Bleeding incidences were recorded at Screening, Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6. All Bleeding incidences at each visit are presented.|From the start of study treatment (Day 1) up to the end of Week 6 of Stage 1|ITT Population||Participants|||Number
666172|NCT01762761|Secondary|Number of Participants Achieving a Platelet Count >=30×10^9/L and at Least 2 Times the Baseline Platelet Count at Least Once During the 6 Weeks of Stage 1|The number of participants achieving a platelet count >=30×10^9/L and at least 2 times the Baseline platelet count at least once during the first 6 weeks of Stage 1 were analyzed. The Baseline platelet count is defined as the platelet count taken on Day 1 of the study or within 48 hours prior to the first dose of investigational product. Logistic regression analysis was adjusted for use of ITP medication at Baseline (yes/no), splenectomy (yes/no), Baseline platelet count <=15×10^9/L (yes/no) and treatment. Complete blood count including platelet count was done at Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6.|From the start of study treatment (Day 1) up to the end of Week 6 of Stage 1|ITT Population. One participant did not have a Baseline platelet count due to no platelet count collected on Day 1 or within 48 hours prior to the first dose of investigational product;therefore, this participant was not evaluable in this table.||Participants|||Number
666173|NCT01762761|Secondary|Number of Participants Achieving a Platelet Count >=50×10^9/L at Least Once During the First 6 Weeks of Stage 1|The number of participants (responders) with platelet count >=50×10^9/L at least once during the first 6 weeks of Stage 1 were compared between treatments using a logistic regression model adjusted for use of ITP medication at Baseline (yes/no), splenectomy (yes/no), Baseline platelet count <=15×10^9/L (yes/no) and treatment. Complete blood count including platelet count was done at Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6.|From the start of study treatment (Day 1) up to the end of Week 6 of Stage 1|ITT Population||Participants|||Number
666174|NCT01762761|Primary|Number of Participants (Responders) Achieving a Platelet Count >=50×10^9/L After the First 6 Weeks of Stage 1|The number of participants (responders) with platelet count >=50x10^9/L after 6 weeks of Stage 1 were compared between treatments using a logistic regression model adjusted for use of primary immune thrombocytopenia (ITP) medication at Baseline (yes/no), splenectomy (yes/no), Baseline platelet count <=15×10^9/L (yes/no) and treatment. Complete blood count including platelet count was done at Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6. Primary Analysis Data Set: a participant who withdrawals from Stage 1 or is emergently unblinded was classified as a negative response from the time of withdrawal or unblinding date and for all subsequent visits. In the event of a participant dying, information for all subsequent assessments would be considered missing. All intermittent missing data (apart from withdrawals) will be treated as missing.|From the start of study treatment (Day 1) up to the end of Week 6 of Stage 1|Intent-to-Treat (ITT) Population: all randomized participants who received at least one dose of study medication and with at least one platelet count post-Baseline in Stage 1.||Participants|||Number
666175|NCT01762722|Primary|Accuracy of Sensor|A scatterplot is created with the forehead sensor saturation on the y-axis and the measured blood saturation on the x-axis. The line of identity is drawn representing the ideal points, meaning that the forehead sensor saturation is always the same as the blood saturation. The dispersion of the actual data points around this line of identity can be measured using a statistical calculation called Arithmetic Root Mean Square or ARMS. The smaller the ARMS the closer the data points lie around the line of identity, representing a more accurate sensor.|Data collected from individual participants over 1 hour timeframe. Data from cohort of subjects collected over 6 month period.|Multiple data points from each individual were pooled and presented as group data.||percentage saturation||Full Range|Mean
666176|NCT01762501|Secondary|Change in 24-hour Mean Diastolic Blood Pressure Level|Change from the start of the run-in period (Week -1) at the end of the treatment period (Week 8)|Baseline and 8 weeks|||mmHg||Standard Deviation|Mean
666177|NCT01762501|Secondary|Change in 24-hour Mean Systolic Blood Pressure Level|Change from the start of the run-in period (Week -1) at the end of the treatment period (Week 8)|Baseline and 8 weeks|||mmHg||Standard Deviation|Mean
666178|NCT01762501|Secondary|Change in Nocturnal Diastolic Blood Pressure Level|Change from the start of the run-in period (Week -1) at the end of the treatment period (Week 8)|Baseline and 8 weeks|||mmHg||Standard Deviation|Mean
666179|NCT01762501|Secondary|Change in the Absolute Value in Difference With Targeted Value* (15 Percent) of Nocturnal Systolic Blood Pressure Fall**|"Change from the start of the run-in period (Week -1) at the end of the treatment period (Week 8) *The targeted value has been set as the median of the dipping rate, normal type of nocturnal blood pressure variation, rate of nocturnal blood pressure fall (10-20 percent)
** Rate of nocturnal blood pressure fall: calculated as (awake SBP-sleep SBP)/awake SBP"|Baseline and 8 weeks|||mmHg||95% Confidence Interval|Mean
666180|NCT01762501|Primary|Change in Nocturnal Systolic Blood Pressure Level|"Change at the end of a treatment period (Week 8) from the beginning point of an observation period
*Nocturnal systolic blood pressure level: the mean value of systolic arterial pressure during night (during sleeping)"|Baseline and 8 weeks|||mmHg||Standard Deviation|Mean
666183|NCT01762345|Secondary|Change in Quality of Life as Measured by Incontinence Impact Questionnaire (IIQ-7)|The IIQ-7 is based on 7 questions referring to areas which may have been influenced or changed by accidental urine loss and/or prolapse. These questions are assigned a value of, 0 = ‘Not at all,’ 1= ‘Slightly,’ 2 = ‘Moderately,’ or 3 ‘Greatly.’ The IIQ-7 is scored by taking the average score of items and then multiplying the average by 33 1/3 to put scores on a scale from 0 to 100. A lower score is considered less impact to quality of life and a higher score reflects more impact to quality of life. In the same manner, a reduction in scores from baseline reflects improved quality of life.|baseline and end-of-treatment|"Intent-to-Treat (ITT) population. The Number of Participants Analyzed is the number subjects with available (non-missing) data at the end of treatment"||units on a scale||Inter-Quartile Range|Median
666184|NCT01762345|Secondary|Change in Stress Urinary Incontinence Episodes|Change from baseline as measured as reduction (improvement) in stress urinary incontinence episodes. Positive values are indicative of efficacious outcome.|from the 14-day baseline period to the first 7 days of 14-day device usage period|"Intent-to-Treat (ITT) population. The Number of Participants Analyzed is the number subjects with available (non-missing) data in week 1"||episodes/usage period||Inter-Quartile Range|Median
666185|NCT01762345|Secondary|Change in Pad Weight Gain|Change from baseline as measured as reduction (improvement) in pad weight gain. Positive values are indicative of efficacious outcome.|from the 14-day baseline period to the first 7 days of 14-day device usage period|"Intent-to-Treat (ITT) population. The Number of Participants Analyzed is the number subjects with available (non-missing) data in week 1"||grams/usage period||Inter-Quartile Range|Median
666186|NCT01762345|Primary|Change in Stress Urinary Incontinence Episodes|Change from baseline as measured as reduction (improvement) in stress urinary incontinence episodes. Positive values are indicative of efficacious outcome.|from the 14-day baseline period to the last 7 days of 14-day device usage period|"Intent-to-Treat (ITT) population. The Number of Participants Analyzed is the number subjects with available (non-missing) data in week 2"||episodes/usage period||Inter-Quartile Range|Median
666187|NCT01762345|Primary|Change in Pad Weight Gain|Change from baseline as measured as reduction (improvement) in pad weight gain. Positive values are indicative of efficacious outcome.|from the 14-day baseline period to the last 7 days of 14-day device usage period|"Intent-to-Treat (ITT) population. The Number of Participants Analyzed is the number subjects with available (non-missing) data in week 2"||grams/usage period||Inter-Quartile Range|Median
666188|NCT01762059|Other Pre-specified|Mean Blood Sugar as Measured by Continuous Glucose Monitor (CGM) Readings||Days 2-5|||mg/dL||Standard Deviation|Mean
666189|NCT01762059|Other Pre-specified|Fraction of Time Spent Within Each of the Following Glucose Ranges: < 70 mg/dl,70-120 mg/dl,70-180 mg/dl,>180 mg/dl,>250 mg/dl||Days 2-5|||percentage of time||Standard Deviation|Mean
666190|NCT01762059|Other Pre-specified|Difference in the Percentage of Subjects With Mean CGMG <154mg/dl During the Closed-loop Period vs. the Usual Care Period||5 days|||percentage of subjects|||Number
666191|NCT01762059|Other Pre-specified|Percentage of Subjects With Mean CGMG < 154mg/dl||5 days|||percentage of subjects|||Number
666192|NCT01762059|Secondary|Difference of Outcome Measures on Day 1 vs. Remaining Days (Days 2-5) During the Closed-loop Period.||5 Days|Data were not collected|||||
666193|NCT01762059|Secondary|Number of Hypoglycemic Episodes During Exercise.||5 days|Data were not collected|||||
666194|NCT01762059|Secondary|Mean BG During Exercise.||5 days|Data were not collected|||||
666195|NCT01762059|Secondary|Difference of Outcome Measures on Days 1-2 vs. on Remaining Days (Days 3-5) During the Closed-loop Period.||5 Days|Data were not collected|||||
666196|NCT01762059|Secondary|Fraction of Time Spent Within Each of the Following Glucose Ranges as Determined From All GlucoScout and HemoCue Measurements.|"Measurements adjusted for the frequency of measurement (i.e. modeled so that more frequent measurements at the time of hypoglycemia and exercise will not skew the mean):
< 70 mg/dl,70-120 mg/dl,70-180 mg/dl, >180 mg/dl, >250 mg/dl"|5 Days|Data were not collected|||||
666197|NCT01762059|Secondary|Average BG During the Closed-loop Control Period as Determined From All GlucoScout Measurements Taken During the Nighttime Monitoring.|This outcome measure was only assessed for the closed loop control period, and was not assessed during the usual care arm.|5 days|This outcome measure was only assessed for the closed loop control period, and was not assessed during the usual care arm.||mg/dl||Standard Deviation|Mean
666198|NCT01762059|Secondary|Correlation Between Exercise Intensity and Likelihood of a Hypoglycemic Event||5 days|Data were not collected|||||
666199|NCT01762059|Secondary|Nadir BG During Exercise.||5 days|Data were not collected|||||
666200|NCT01762059|Secondary|Number of Hypoglycemic Events as Determined From GlucoScout and HemoCue Measurements.||5 days|Data were not collected|||||
666201|NCT01762059|Secondary|Difference in the Percentage of Subjects With Mean BG < 154 mg/dl During the Closed-loop Period vs. the Usual Care Period.||5 days|Data were not collected|||||
666202|NCT01762059|Secondary|Percentage of Subjects With Mean BG < 154 mg/dl.|This outcome measure was only assessed for the closed loop control period, and was not assessed during the usual care arm.|5 days|This outcome measure was only assessed for the closed loop control period, and was not assessed during the usual care arm.||percentage of participants|||Number
666203|NCT01762059|Secondary|Difference in the Percentage of the Above Subset of BG Values Between the Closed-loop Control and Usual Care Periods Less Than 70 mg/dl.||5 days|Data were not collected|||||
666204|NCT01762059|Secondary|Difference in the Average BG Between the Closed-loop Control Period and the Usual Care Period.||5 days|Data were not collected|||||
666205|NCT01762059|Secondary|Percentage of the Subset of BG Values Less Than 70 mg/dl as Determined From All All HemoCue Measurements Taken During the Daytime and Scheduled GlucoScout Measurements Taken During the Nighttime.||5 days|This outcome measure was only assessed for the closed loop control period, and was not assessed during the usual care arm.||percentage of time||Standard Deviation|Mean
666206|NCT01762059|Secondary|Average BG During the Closed-loop Control Period as Determined From All HemoCue Measurements Taken During the Daytime and All Scheduled GlucoScout Measurements During the Nighttime.|During usual care (open loop), blood sugars were not checked through GlucoScout or HemoCue (as per usual care fashion) and so were not compared to bionic pancreas (closed loop) arm|5 days|This outcome measure was only assessed for the closed loop control period, and was not assessed during the usual care arm.||mg/dl||Standard Deviation|Mean
666208|NCT01762059|Primary|Average Blood Glucose (Co-primary Outcome)|Average blood glucose during the closed-loop control period as determined from HemoCue capillary measurements (daytime+nightime) and GlucoScout venous measurements (nighttime).|5 days of closed-loop control|This outcome measure was only assessed for the closed loop control period, and was not assessed during the usual care arm.||mg/dL||Standard Deviation|Mean
666209|NCT01761747|Secondary|Define the Response Rate to Ponatinib is Patients With FGFR Amplifications Versus Mutations|Identify the response rate to ponatinib for FGFR specific FGFR amplifications/mutations.|2 years|There were no observed responses on study so this outcome could not be determined.|||||
666210|NCT01761747|Secondary|Determine the Correlation FGFR Amplifications/Mutations With Patient Age, Sex, Disease Stage, Prior Response to Treatment and Smoking History|For subjects with FGFR amplifications and for FGFR mutations we will ascertain the age, sex, disease stage, prior response to treatment and smoking history from past medical records and measure whether there are differences in these variables among subjects with amplification versus mutation.|2 years|Too few subjects were enrolled on study to permit this outcome measure analysis.|||||
666211|NCT01761747|Secondary|Disease Control|Measure the disease control rate of patients treated with ponatinib|2 years|||percentage of subjects|||Number
666212|NCT01761747|Secondary|Overall Survival|Measure the overall survival time of patients treated with ponatinib|2 years|||days||Full Range|Mean
666213|NCT01761747|Secondary|Define Toxicities of Ponatinib|Number of Participants with Adverse Events as a Measure of Safety and Tolerability|2 years|||participants|||Number
666214|NCT01761747|Secondary|Progression-free Survival|Establish the progression-free survival of patients with SCC treated with ponatinib as defined by time to development of progression by RECIST criteria.|2 years|||days||Full Range|Mean
666215|NCT01761747|Secondary|Prevalence of Specific FGFR Amplifications/Mutations in the Study Population|Test tumor DNA using molecular assays to measure the frequency of FGFR amplifications and mutations in study patients|2 years|2 participants had FGFR amplification, one with FGFR mutation||participants|||Number
666216|NCT01761747|Primary|Response Rate of Patients With Lung or Head and Neck SCC Treated With Ponatinib|"Investigate the response rate of patients with previously treated lung or head and neck SCC to ponatinib as defined by the proportion of subjects with investigator-assessed confirmed complete response (CR) or partial response (PR).
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|2 years|||percentage of subjects with response|||Number
666217|NCT01761565|Primary|CST½|the time for plasma concentrations to decrease from Cmax to 50% of Cmax after discontinuation of drug administration|24|2 of the 40 subjects had incomplete PK data and were excluded from PK analysis (1 due to early withdrawal and 1 due to AE)||hours||Full Range|Median
666218|NCT01761565|Primary|Time to Steady State|Steady state, for the cohort, was assessed using Helmert’s method (ratio of the geometric mean concentration of each time point to the geometric mean concentrations pooled over all remaining time points, and achieved at the first not-statistically significant time point (i.e., p >0.05)|24 hours|2 of the 40 subjects had incomplete PK data and were excluded from PK analysis (1 due to early withdrawal and 1 due to AE)||hours|||Number
666219|NCT01761565|Primary|Cmax|"For Treatment A, serial blood samples were taken at 0 (predose), 5, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, 800, and 840 minutes, and 24 hours after the Sufentanil NanoTab dose on Day 1.
For Treatment B, serial blood samples were collected at 0, 20, 120, 240, 360, 480, 600, 720, 760, 780, 785, 790, 795, 800, 810, 820, 830, 840, 850, 860, 870, 900, 960, 1020, 1140, 1260, 1380, 1500, 1580, and 1620 minutes, and 37 hours after the first Sufentanil NanoTab dose on Day 3"|24 hours in Treatment A, 37 hours in Treatment B|2 of the 40 subjects had incomplete PK data and were excluded from PK analysis (1 due to early withdrawal and 1 due to AE)||pg/mL||Standard Deviation|Mean
666220|NCT01761279|Other Pre-specified|Accuracy of Prediction of Polyp Surveillence Intervals|Accuracy of prediction of post-polypectomy surveillence colonoscopy intervasl based on national guidelines. Intervals based on in-vivo assessment of all polyps ≤5mm in size combined with histopathology of polyps >5mm in size will be compared to intervals determined by histopathology of all polyps|Once histopathology results are known, approximately 2 weeks after in-vivo assessment|84 study participants in total. One patient excluded from this analysis as a single polyp was not retrieved for histological analysis.||Percentage correct surveillence interval|||Number
666221|NCT01761279|Secondary|Negative Predictive Value for Adenomatous Histology of Rectosigmoid Polyps ≤5mm in Size|Negative predictive value for adenomatous histology of rectosigmoid polyps ≤5mm in size using high definition white light endoscopy and high definition white light endoscopy plus i-Scan image enhancement. NPV compared to the gold standard of histopathology. Negative predictive value = number of true negatives/(number of true negatives + number of false negatives)|Once histopathology results are known, approximately 2 weeks after in-vivo assessment|Numbers indicate the number of rectosigmoid polyps <5mm in size assessed as being non-neoplastic||Percentage Negative Predictive Value|Participants|95% Confidence Interval|Number
666222|NCT01761279|Secondary|Specificity for Adenomatous Histology of Colonic Polyps <10mm in Size|Specificity for adenomatous histology of in-vivo assessment of colonic polyps <10mm in size using high definition white light endoscopy and high definition white light endoscopy plus i-Scan image enhancement. Specificity compared to the gold standard of histopathology. Specificity for adenomatous histology = number of correctly identified non-neoplastic polyps (true negatives)/total number of non-neoplastic polyps (true negatives + false positives)|Once histopathology results are known, approximately 2 weeks after in-vivo assessment|75 is the number of non-neoplastic polyps included in the study.||Percentage specificity|Participants|95% Confidence Interval|Number
666223|NCT01761279|Secondary|Sensitivity for Adenomatous Histology of Colonic Polyps <10mm in Size|Sensitivity for adenomatous histology of in-vivo assessment of colonic polyps <10mm in size using high definition white light endoscopy and high definition white light endoscopy plus i-Scan image enhancement. Sensitivity compared to the gold standard of histopathology. Senstivity for adenomatous histology = number of correctly identified adenomas (true positives)/total number of adenomas (true positives + false negatives)|Once histopathology results are known, approximately 2 weeks after in-vivo assessment|134 is the number of adenomatous polyps included in the study.||Percentage sensitivity|Participants|95% Confidence Interval|Number
666224|NCT01761279|Primary|Diagnostic Accuracy of In-vivo Polyp Assessment|Diagnostic accuracy of in-vivo assessment of colonic polyps <10mm in size using high definition white light endoscopy and high definition white light endoscopy plus i-Scan image enhancement. Accuracy compared to the gold standard of histopathology. Accuracy - number of polyps with histology correctly predicted by in-vivo method/total number of polyps assessed (Expressed as a percentage)|Once histopathology results are known, approximately 2 weeks after in-vivo assessment|There were 84 patients included in the study. 209 polyps <10mm included in the study.||% diagnostic accuracy|Participants|95% Confidence Interval|Number
666225|NCT01761175|Secondary|Duration of Tourniquet|The total time the tourniquet was left inflated|The end of surgery|||minutes||Inter-Quartile Range|Median
666226|NCT01761175|Secondary|Tourniquet Use|Number of participants who had a tourniquet during the surgery|The end of surgery|One patient in the infraclavicular block had an anatomic variation precluding block performance. He was considered a block failure for the primary outcome and for the secondary outcomes of complete motor block and surgical success, on the basis of an intention-to-treat analysis. This patient was not included in the remaining secondary outcomes.||participants|||Number
666227|NCT01761175|Secondary|Duration of Surgery||The end of surgery|One patient in the infraclavicular block had an anatomic variation precluding block performance. He was considered a block failure for the primary outcome and for the secondary outcomes of complete motor block and surgical success, on the basis of an intention-to-treat analysis. This patient was not included in the remaining secondary outcomes.||minutes||Inter-Quartile Range|Median
666228|NCT01761175|Secondary|Number of Patients With Postoperative Adverse Events Related to Nerve Block|Adverse events were defined by residual numbness, loss of sensitivity or weakness in the operated arm related to block performance or signs of hematoma or infection at the puncture site.|1 month after surgery|Eight patients in the infraclavicular group and five in the axillary group could not be contacted in the pre-established time frame.||participants|||Number
666229|NCT01761175|Secondary|Number of Patients With Postoperative Adverse Events Related to Nerve Block|Adverse events were defined by residual numbness, loss of sensitivity or weakness in the operated arm related to block performance or signs of hematoma or infection at the puncture site.|24 hours after surgery|Four patients in the infraclavicular group and six in the axillary group could not be contacted in the pre-established time frame.||participants|||Number
666230|NCT01761175|Secondary|Procedure-related Pain on a Visual Analog Pain Scale|Pain was evaluated by the patient on a visual analog pain scale ranging from 0 (no pain) to 10 (worst pain of their life).|After the nerve block procedure ended, up to 5 minutes.|One patient in the infraclavicular block had an anatomic variation precluding block performance. He was considered a block failure for the primary outcome and for the secondary outcomes of complete motor block and surgical success. This patient was not included in the other secondary outcomes. 3 other participants had missing data for this outcome.||units on a scale||Inter-Quartile Range|Median
666231|NCT01761175|Secondary|Performance Time of the Nerve Block|Performance time is defined as the sum of imaging time (defined as the time elapsed from the moment the Doppler probe is in contact with the patient to the insertion of the Tuohy needle) and needling time (from the insertion of the needle to its complete removal).|During the performance of the block|One patient in the infraclavicular block had an anatomic variation precluding block performance. He was considered a block failure for the primary outcome and for the secondary outcomes of complete motor block and surgical success, on the basis of an intention-to-treat analysis. This patient was not included in the remaining secondary outcomes.||seconds||95% Confidence Interval|Mean
666232|NCT01761175|Secondary|Surgical Block Success Rate|Surgical block success is defined by a nerve block allowing surgery without a rescue block, an infiltration of local anesthetics by the surgeon, administration of analgesics for pain in the surgical field or a general anesthesia.|End of surgery|||percentage of participants||95% Confidence Interval|Number
666233|NCT01761175|Secondary|Time to Complete Motor Block|Complete motor block is defined by paralysis in the median, ulnar, radial and musculocutaneous nerves territories.|5, 10, 15, 20, 25 and 30 minutes after block completion|One patient in the infraclavicular block had an anatomic variation precluding block performance. He was considered a block failure for the primary outcome and for the secondary outcomes of complete motor block and surgical success, on the basis of an intention-to-treat analysis. This patient was not included in the remaining secondary outcomes.||percentage of participants||95% Confidence Interval|Number
666234|NCT01761175|Secondary|Time to Complete Sensory Block.|Complete sensory block is defined by anesthesia to cold sensation in the median, ulnar, radial and musculocutaneous nerves territories.|5, 10, 15, 20, 25 and 30 minutes after block completion|One patient in the infraclavicular block had an anatomic variation precluding block performance. He was considered a block failure for the primary outcome and for the secondary outcomes of complete motor block and surgical success, on the basis of an intention-to-treat analysis. This patient was not included in the remaining secondary outcomes.||percentage of participants||95% Confidence Interval|Number
666235|NCT01761175|Secondary|Number of Patients With Complete Motor Blocks|Complete motor block is defined by paralysis in the ulnar, radial, median and musculocutaneous nerves territories.|30 minutes after block completion|||percentage of participants||95% Confidence Interval|Number
666236|NCT01761175|Primary|Number of Patients With Complete Sensory Block|Complete sensory block is defined by anesthesia to cold sensation in the ulnar, radial, median and musculocutaneous nerves territories.|30 minutes after block completion|Statistical analyses were conducted according to the intention-to-treat principle||percentage of participants||90% Confidence Interval|Number
666237|NCT01761162|Primary|Percentage of Participants Free of R-wave Sensing Attenuation|Evaluate the percentage of subjects free of R-wave attenuation between the pre-MRI and one-month post-MRI follow-up.|Pre-MRI, 1 Month Post-MRI|Number of participants with a ventricular lead and same ventricular sensing polarity (either uni- or bipolar) at pre-MRI and one-month post-MRI.||percentage of participants||95% Confidence Interval|Number
666238|NCT01761162|Primary|Percentage of Participants Free of P-wave Sensing Attenuation|Evaluate the percentage of subjects free of P-wave attenuation between the pre-MRI and one-month post-MRI follow-up.|Pre-MRI, 1 Month Post-MRI|Number of participants with an atrial lead and same atrial sensing polarity (either uni- or bipolar) at pre-MRI and one-month post-MRI.||percentage of participants||95% Confidence Interval|Number
666265|NCT01760889|Secondary|Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at 26 Weeks||Baseline and 26 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
666239|NCT01761162|Primary|Percentage of Participants Free of Ventricular Pacing Threshold Rise|Evaluate the percentage of ventricular pacing leads free of pacing threshold increase between the Pre-MRI and one-month post-MRI follow-up.|Pre-MRI, 1 Month Post-MRI|Number of participants with a ventricular lead and same ventricular threshold polarity (either uni- or bipolar) at pre-MRI and one-month post-MRI.||percentage of participants||95% Confidence Interval|Number
666240|NCT01761162|Primary|Percentage of Participants Free of Atrial Pacing Threshold Rise|Evaluate the percentage of atrial pacing leads free of pacing threshold increase between the pre-MRI and one-month post-MRI follow-up.|Pre-MRI, 1 Month Post-MRI|Number of participants with an atrial lead and same atrial threshold polarity (either uni- or bipolar) at pre-MRI and one-month post-MRI.||percentage of participants||95% Confidence Interval|Number
666241|NCT01761162|Primary|MRI and Pacing System Related Serious Adverse Device Effect (SADE) Free Rate||1 Month Post-MRI|||percentage of participants||95% Confidence Interval|Number
666242|NCT01761019|Secondary|Desire to Change to Another Systemic Therapy|We will measure the difference in percent of subjects who wish to change to another systemic therapy at baseline vs at week 12.|12 weeks|||Percentage of participants|||Number
666243|NCT01761019|Secondary|Patient Satisfaction|"• Subject satisfaction: We also ask subjects for their level of satisfaction with their current treatment at week 12. They will be given the following options: very satisfied, satisfied, somewhat disappointed or very disappointed. For measurement very satisfied=4, satisfied=3, somewhat disappointed=2 and very disappointed=1. We will determine the mean satisfaction of all patients at week 12."|12 weeks|||units on a scale||Standard Deviation|Mean
666244|NCT01761019|Secondary|Safety|Throughout this study, adverse events and serious adverse events will be collected|12 weeks|||adverse event|||Number
666245|NCT01761019|Secondary|Body Surface Area|This is a measure of the percentage of the body involved with psoriasis. We will measure the change in percentage of body area involved with psoriasis from baseline to week 12.|12 weeks|||percentage of body surface area||Standard Deviation|Mean
666246|NCT01761019|Primary|Investigator Global Assessment|This is score from 0-5 that measures, in the opinion of the study doctor, the severity of psoriasis on a subject, with 5 being most severe and 0 least severe. The change in this score between baseline and week 12 will be measured.|12 weeks|||units on a scale||Standard Deviation|Mean
666247|NCT01760993|Secondary|Change From Baseline in Social Functioning Scale (SFS) at 52 Weeks||Baseline and 52 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
666248|NCT01760993|Secondary|Clinical Global Impression-Schizophrenia Degree of Change (CGI-SCH-C) Scale||Up to 52 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
666249|NCT01760993|Secondary|Clinical Global Impression-Schizophrenia Severity of Illness (CGI-SCH-S) Scale||Baseline and week 52|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
666250|NCT01760993|Secondary|Change From Baseline in the Personal and Social Performance (PSP) Scale Score at 52 Weeks||Baseline and 52 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
666251|NCT01760993|Secondary|Change From Baseline in Negative Symptom Assessment (NSA-16) Total Score at 52 Weeks||Baseline and 52 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
666252|NCT01760993|Primary|Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at 52 Weeks||Baseline and 52 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
666253|NCT01760993|Primary|Change From Baseline in Clinical Evaluation of Harmful Behavior (CEHB) Scale at 52 Weeks||Baseline and 52 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
666254|NCT01760993|Primary|Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) at 52 Weeks||Baseline and 52 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
666255|NCT01760993|Primary|Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at 52 Weeks||Baseline and 52 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
666256|NCT01760993|Primary|Change From Baseline in Simpson Angus Scale (SAS) Total Score at 52 Weeks||Baseline and 52 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
666257|NCT01760993|Primary|Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at 52 Weeks||Baseline and 52 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
666258|NCT01760993|Primary|Columbia-Suicide Severity Rating Scale (C-SSRS)||Up to 52 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
666259|NCT01760993|Primary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at 52 Weeks||Baseline and 52 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
666260|NCT01760993|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at 52 Weeks||Basline and 52 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
666261|NCT01760941|Other Pre-specified|Quantify the Percentage of Patients Receiving the Treatment Who Believe That the Treatment Was Worthwhile|Quantify the percentage of patients receiving the treatment who believe that the treatment was worthwhile|6 months||||||
666262|NCT01760941|Secondary|Evaluate the Treatment Influence on Patient Quality of Life|Evaluate the treatment influence on patient quality of life as measured by the ESAS.|2 weeks||||||
666263|NCT01760941|Secondary|Evaluate the Treatment Influence on the Rate of Pain Stabilization and/or Reduction|Evaluate the treatment influence on the rate of pain stabilization and/or reduction as measured by the validated BPI patient questionnaire.|2 weeks||||||
666264|NCT01760941|Primary|Feasibility of Treatment Delivery in the Same Day as Initial Evaluation|Patient evaluation will consist of surveys conducted at the time of treatment measured by the Radiation Oncologist Evaluation and Feasibility Assessments survey|Up to 6 months||||||
666266|NCT01760889|Secondary|Columbia-Suicide Severity Rating Scale (C-SSRS)||Up to 26 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
666268|NCT01760889|Secondary|Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at 26 Weeks||Baseline and 26 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
666269|NCT01760889|Secondary|Clinical Global Impression-Schizophrenia Degree of Change (CGI-SCH-C) Scale||Up to 26 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
666270|NCT01760889|Secondary|Clinical Global Impression-Schizophrenia Severity of Illness (CGI-SCH-S) Scale||Baseline and week 26|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
666271|NCT01760889|Secondary|Change From Baseline in Social Functioning Scale (SFS) at 26 Weeks||Baseline and 26 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
666272|NCT01760889|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at 26 Weeks||Baseline and 26 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
666273|NCT01760889|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at 26 Weeks||Baseline and 26 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
666274|NCT01760889|Secondary|Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) at 26 Weeks||Baseline and 26 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
666275|NCT01760889|Secondary|Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at 26 Weeks||Baseline and 26 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
666276|NCT01760889|Secondary|Change From Baseline in Simpson Angus Scale (SAS) Total Score at 26 Weeks||Baseline and 26 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
666277|NCT01760889|Secondary|Change From Baseline in the Personal and Social Performance (PSP) Scale Score at 26 Weeks||Baseline and 26 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
666278|NCT01760889|Primary|Change From Baseline in Negative Symptom Assessment (NSA-16) Total Score at 26 Weeks||Baseline and 26 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
666279|NCT01760876|Secondary|OCT Endpoints (Neointimal Metrics), QCA Endpoints (Late Lumen Loss at 9 Months), and Clinical Endpoints (MACE at 9 Months and 12 Months). A Subgroup Analysis Would be Performed for Diabetic Patients.|Secondary endpoints would consist of OCT endpoints (neointimal area, neointimal thickness, neointimal volume, and percentage neointimal volume ), QCA endpoints (late lumen loss at 9 months), and clinical endpoints (MACE, including stent thrombosis up to 12 months). A subgroup analysis will be performed for DM patients.|9 months and 12 months||12/2017||||
666280|NCT01760876|Primary|OCT Findings on Coverage (Degree of Endothelialisation/Coverage) From 1 to 9 Months.|"The percentage of strut coverage and category of coverage (A to F) from 1 month to 9 months by longitudinal sequential OCT assessments.
A. Definitely uncovered – strut not covered by tissue, and both sides appear square; B. Uncovered with abnormal in-stent tissue – strut covered by irregular tissue or fibrin, and both sides appear square; C. Partially uncovered – strut partially covered by tissue but only one side has a smooth continuous shoulder; D. Covered (protruding) – strut covered by thin continuous tissue on both sides but still extending into the lumen; E. Covered (embedded) – strut covered by continuous tissue or neointima and not interrupting the smooth lumen contour; F. Covered (proliferative) – strut covered with excessive growth of neointima with thickness >0.3 mm."|1 to 9 months|100 patients treated with BF stents and randomly assigned to 5 monthly groups (n = 20:20:20:20:20) at 1 to 5 months receiving OCT follow-up, and then 100 patients altogether at 9 months for another follow-up.||percentage of strut coverage (D+E+F)||Inter-Quartile Range|Median
666281|NCT01760785|Secondary|Frequency of Alcohol Use|Frequencies of alcohol use/misuse will be measured weekly utilizing the Timeline Followback assessment. Participants will also be given an alcohol breath test at every clinic visit.|Weeks 1-10||||||
666282|NCT01760785|Primary|Severity of Affective Lability Based on Shortened Agitated Behavior Scale|Severity of affective lability was measured using a shortened version of the Agitated Behavior Scale (ABS). The ABS is used to assess the nature and extent of present agitation. Eight items from the 14-item scale were used, which measured the presence and severity of various affective lability symptoms including: short attention span, impulsivity, uncooperative behavior, violent tendencies, restlessness, rapid or excessive talking, sudden changes in mood, and easily initiated or excessive crying and/or laughter. Each of the eight items was scored using a 1-4 Likert scale, where 1 stands for absence of symptom and 4 stands for presence to an extreme degree. The minimum possible score for this measure was 8, and the maximum possible score was 32. Due to the nature of the measure, a lower score indicated less severe affective lability, while conversely higher scores indicated more severe affective lability. The mean of scores for weeks 2 through 8 for each group were reported.|Weeks 2 through 8|||units on a scale||Standard Error|Mean
666283|NCT01760473|Secondary|SOWS|Subjective opioid withdrawal scale (SOWS) measure (0-64). Greater score indicates more severe withdrawal.|Throughout the testing sessions (approximately 9 weeks).|||units on a scale||Standard Error|Mean
666284|NCT01760473|Primary|Drug Self-administration|The maximum number of responses (clicks on a computer mouse) the participant was willing to perform in order to receive a dose of the intranasal challenge drug under investigation.|Throughout the testing sessions (approximately 9 weeks).|||Clicks on a computer mouse||Standard Error|Mean
666285|NCT01760304|Secondary|Evaluation of O2 Pulse|Evaluation of O2 Pulse is the measurement of oxygen consumption pre and post intervention|Change from Baseline and 45 minutes after administration of study medication or placebo|||ml/beat||95% Confidence Interval|Mean
666286|NCT01760304|Secondary|Lung Hyperinflation|Evaluation of lung hyperinflation as determined by Pulmonary function test where Inspiratory Capacity (IC) before and 45 minutes after the administration of the budesonide/formoterol or placebo.|Change from Baseline and after 45 minutes after administration of study medication or placebo|||Liters||95% Confidence Interval|Mean
666305|NCT01759368|Secondary|P-proBNP|Change in plasma concentration of brain natriuretic peptide propeptide from baseline to the end of the study.|From baseline until the end of the study at six months|||ng/l||Inter-Quartile Range|Median
666287|NCT01760304|Primary|Cardiac Output|"Impedance cardiography (ICG) (BioZ Dx ICG machine, by CardioDynamics) was used to measure cardiac output without the need for invasive devices. Cardiac output measurement by impedance cardiography (CO-ICG) is a plethysmography technique using sensors to detect the properties of the blood flow in the thorax.
All subjects had on each visit a baseline measurement at rest and then 45 minutes after intervention (Budesonide/formoterol or Placebo). Measurement were performed at rest for 5 minutes to obtain a steady state and the last 2 minutes were taken for analysis as an averaged value labeled as pre and post intervention. For the analysis we calculated the difference from pre and post intervention at each visit. Paired t-test was used to compare the mean+/- SD of the pre and post difference when taking the study drug vs placebo."|Change from Baseline and at 45 minutes after administration of study medication or placebo|||ml/beat||95% Confidence Interval|Mean
666288|NCT01759602|Secondary|Expanded Disability Status Score (EDSS)|"The Kurtzke Expanded Disability Status Scale (EDSS) was developed to measure the disability status of patients with multiple sclerosis. It allows an objective quantification of the level of functioning that could be widely and reproducibly used by researchers and health care providers.
The EDSS provides a total score on a scale that ranges from 0 to 10. The first levels 1.0 to 4.5 refer to people with a high degree of ambulatory ability and the subsequent levels 5.0 to 9.5 refer to the loss of ambulatory ability. The range of main categories include (0) = normal neurologic exam; to (5) = ambulatory without aid or rest for 200 meters; disability severe enough to impair full daily activities; to (10) = death due to MS. In addition, it also provides eight subscale measurements called Functional System (FS) scores."|participants were followed for the duration of hospital stay ranging from 5-21 days, an average of 13 days; EDSS assessment was administered at discharge|||EDSS scores||Full Range|Median
666289|NCT01759602|Secondary|Change From Baseline in Hematology, Chemistry, and Urinalysis Parameters.|"ALT elevations were considered mild if they rose to less than 4-fold baseline levels."|5-21 days|||participants|||Number
666290|NCT01759602|Secondary|Percentage of Subjects Withdrawing Due to Adverse Events.||5-21 days|||percentage of subjects withdrawing|||Number
666291|NCT01759602|Secondary|Frequency of Serious Adverse Events.||5-21 days|||serious adverse events|||Number
666292|NCT01759602|Primary|Number of Adverse Safety Events During Hospitalization|Over the course of hospitalization for the acute NMO exacerbations, subjects will be monitored daily for frequency of adverse events.|5-21 days|||adverse safety events|||Number
666293|NCT01759511|Secondary|Relative Change From Baseline in Serum Lysyl Oxidase-like 2 (sLOXL2) Levels at Weeks 72 and 120||Weeks 72 and 120|Participants in the Safety Analysis set with available data were analyzed.||percent change in sLOXL2||Standard Error|Least Squares Mean
666294|NCT01759511|Secondary|All-cause Mortality|All-cause mortality was assessed as a number of participants who died from any cause.|Up to 165 weeks|Safety Analysis Set||Participants|||Count of Participants
666295|NCT01759511|Secondary|Relative Change From Baseline in DLCO % Predicted at Weeks 72 and 144|"DLCO was a measurement to determine the extent to which oxygen passes from the air sacs of the lungs into the blood.
Least square means were from MMRM model including baseline DLCO % predicted and visit including all data up to Week 144."|Weeks 72 and 144|Participants in Safety Analysis Set with available data were analyzed.||percent change in DLCO % predicted||Standard Error|Least Squares Mean
666296|NCT01759511|Secondary|Relative Change From Baseline in FVC % Predicted at Weeks 72 and 144|"FVC was a pulmonary function test, and was defined as the volume of air that can forcibly be blown out after taking a full breath.
Least square means were from mixed model for repeated measures (MMRM) model including baseline FVC % predicted and visit including all data up to Week 144."|Weeks 72 and 144|Participants in Safety Analysis Set with available data were analyzed.||percent change in FVC % predicted||Standard Error|Least Squares Mean
666297|NCT01759511|Primary|Overall Safety Profile of Simtuzumab|The overall safety of simtuzumab was assessed as the percentage of participants experiencing adverse events (AEs; Serious AEs, Grade 3 or 4 AEs, AEs related to simtuzumab, and AEs leading to discontinuation of simtuzumab), treatment-emergent chemistry and hematology abnormality.|30 days post last study treatment (up to 165 weeks)|Safety Analysis Set||percentage of participants|||Number
666298|NCT01759420|Secondary|Number of Adverse Events|The secondary objective is to determine the number of severe adverse cardiac electrical events (non-sinus rhythm, severe bradycardia, sudden cardiac death) associated with routine use of intravenous ondansetron in the adult emergency department patient. All of these outcomes will be recorded for each patient during the emergency department stay which could range from 20 minutes to several hours.|20 minutes to 8 hours|||percentage of patients||95% Confidence Interval|Number
666299|NCT01759420|Primary|Change in QTc Interval With Ondansetron Administration|The primary objective is to determine the mean maximal prolongation in QTc interval from baseline as measured by the Bazett formula. A baseline EKG will be obtained and then after drug administration an EKG will be performed every 2 minutes until 20 minutes has passed. The mean maximal QTc change will be calculated.|Baseline to 20 minutes|||mS||95% Confidence Interval|Mean
666300|NCT01759381|Primary|Number of Participants With Post-operative Infection (NPWT)|The patient will be assessed for signs/symptoms of infection within the 3 month post-operative period.|3 months|||participants|||Number
666301|NCT01759368|Secondary|Utilization of Health Care Resources|Number of visits to nurse's reception|From baseline until the end of the study at six months|||number of visits||Standard Deviation|Mean
666302|NCT01759368|Secondary|Left Ventricular Ejection Fraction|Change in left ventricular ejection fraction from baseline until the end of the study|From baseline until the end of the study at six months|||percentage unit||95% Confidence Interval|Mean
666303|NCT01759368|Other Pre-specified|Plasma Concentrations of Creatinine, Natrium, and Potassium From the Baseline to the End of the Study|Change in plasma concentrations of creatinine, natrium, and potassium|From baseline to the end of the study at six months||||||
666304|NCT01759368|Secondary|EHFSBS (European Heart Failure Self-Care Behaviour Scale ) Scores|Change in self-care behaviour measured by the European Heart Failure Self-Care Behaviour Scale (EHFSBS). EHFSBS is a 12-item self-administered questionnaire specifically designed and tested for heart failure patients including statements on self-care behaviour essential in the care of HF. The statements are scored from one to five. The lower the score, the better the performance in self-care. The summary score is analysed.|From baseline until the end of the study at six months|||Scores on a scale||95% Confidence Interval|Mean
666306|NCT01759368|Secondary|Heart Transplant|Heart transplant operation or listing for transplant operation|From baseline until the end of the study at six months|||participants|||Number
666309|NCT01759290|Secondary|All Revascularization|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 407 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
666310|NCT01759290|Secondary|Target Vessel Revascularization : Ischemic-driven (ID-TVR)|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 407 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
666311|NCT01759290|Secondary|Target Vessel Revascularization (TVR): All TVR|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 407 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
666312|NCT01759290|Secondary|Target Lesion Revascularization : Ischemia-Driven (ID-TLR)|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 407 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
666313|NCT01759290|Secondary|Target Lesion Revascularization (TLR): All TLR|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 407 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
666314|NCT01759290|Secondary|All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV).|This is one of the Safety Component (non-hierarchical) endpoints.|0 to 407 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
666315|NCT01759290|Secondary|Death (Cardiovascular, Non-Cardiovascular)|This is one of the Safety Component (non-hierarchical) endpoints.|0 to 407 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
666316|NCT01759290|Secondary|All Revascularization|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 180 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
666317|NCT01759290|Secondary|Target Vessel Revascularization : Ischemic-driven (ID-TVR)|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 180 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
666318|NCT01759290|Secondary|Target Vessel Revascularization (TVR): All TVR|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 180 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
666319|NCT01759290|Secondary|Target Lesion Revascularization : Ischemia-Driven (ID-TLR)|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 180 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
666320|NCT01759290|Secondary|Target Lesion Revascularization (TLR): All TLR|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 180 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
666321|NCT01759290|Secondary|All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV).|This is one of the Safety Component (non-hierarchical) endpoints.|0 to 180 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
666361|NCT01759290|Secondary|Subacute ScaffoldThrombosis||1 to 30 days|Analysis population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any Scaffold Thrombosis event.||percentage of participants|||Number
666322|NCT01759290|Secondary|Death (Cardiovascular, Non-Cardiovascular)|This is one of the Safety Component (non-hierarchical) endpoints.|0 to 180 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
666323|NCT01759290|Secondary|All Revascularization|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 37 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
666324|NCT01759290|Secondary|Target Vessel Revascularization : Ischemic-driven (ID-TVR)|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 37 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
666325|NCT01759290|Secondary|Target Vessel Revascularization (TVR): All TVR|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 37 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
666326|NCT01759290|Secondary|Target Lesion Revascularization : Ischemia-Driven (ID-TLR)|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 37 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
666327|NCT01759290|Secondary|Target Lesion Revascularization (TLR): All TLR|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 37 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
666328|NCT01759290|Secondary|All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV).|This is one of the Safety Component (non-hierarchical) endpoints.|0 to 37 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
666329|NCT01759290|Secondary|Death (Cardiovascular, Non-Cardiovascular)|This is one of the Safety Component (non-hierarchical) endpoints.|0 to 37 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
666330|NCT01759290|Secondary|All Revascularization|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 7 days (In-hospital)|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
666331|NCT01759290|Secondary|Target Vessel Revascularization : Ischemic-driven (ID-TVR)|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 7 days (In-hospital)|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
666332|NCT01759290|Secondary|Target Vessel Revascularization (TVR): All TVR|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 7 days (In-hospital)|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
666333|NCT01759290|Secondary|Target Lesion Revascularization : Ischemia-Driven (ID-TLR)|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 7 days (In-hospital)|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
666334|NCT01759290|Secondary|Target Lesion Revascularization (TLR): All TLR|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 7 days (In-hospital)|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
666362|NCT01759290|Secondary|Acute Scaffold Thrombosis||<1 day|Analysis population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any Scaffold Thrombosis event.||percentage of participants|||Number
666335|NCT01759290|Secondary|All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV).|This is one of the Safety Component (non-hierarchical) endpoints.|0 to 7 days (In-hospital)|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
666336|NCT01759290|Secondary|Death (Cardiovascular, Non-Cardiovascular)|This is one of the Safety Component (non-hierarchical) endpoints.|0 to 7 days (In-hospital)|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
666337|NCT01759290|Secondary|All Death/All MI||0 to 407 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
666338|NCT01759290|Secondary|Cardiac Death/All MI||0 to 407 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
666339|NCT01759290|Secondary|Major Adverse Cardiac Event (MACE)|MACE includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).|0 to 407 Days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
666340|NCT01759290|Secondary|Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF)|Target Vessel Failure (TVF) includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Vessel Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).|0 to 407 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
666341|NCT01759290|Secondary|All Death, All MI, All Revascularization (DMR)||0 to 407 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
666342|NCT01759290|Secondary|All Death/All MI||0 to 180 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
666343|NCT01759290|Secondary|Cardiac Death/All MI||0 to 180 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
666344|NCT01759290|Secondary|Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF))|Target Lesion Failure includes Cardiac Death,Target Vessel-Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).|0 to 180 Days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
666345|NCT01759290|Secondary|Major Adverse Cardiac Event (MACE)|MACE includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).|0 to 180 Days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
666346|NCT01759290|Secondary|Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF)|Target Vessel Failure (TVF) includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Vessel Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).|0 to 180 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
666347|NCT01759290|Secondary|All Death, All MI, All Revascularization (DMR)||0 to 180 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
666348|NCT01759290|Secondary|All Death/All MI||0 to 37 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
666349|NCT01759290|Secondary|Cardiac Death/All MI||0 to 37 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
666350|NCT01759290|Secondary|Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF))|Target Lesion Failure includes Cardiac Death,Target Vessel-Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).|0 to 37 Days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
666351|NCT01759290|Secondary|Major Adverse Cardiac Event (MACE)|MACE includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).|0 - 37 Days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
666352|NCT01759290|Secondary|Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF)|Target Vessel Failure (TVF) includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Vessel Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).|0 to 37 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
666353|NCT01759290|Secondary|All Death, All MI, All Revascularization (DMR)||0 to 37 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
666354|NCT01759290|Secondary|All Death/All MI||0 to 7 days (In-hospital)|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
666355|NCT01759290|Secondary|Cardiac Death/All MI||0 to 7 days (In-hospital)|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
666356|NCT01759290|Secondary|Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF))|Target Lesion Failure includes Cardiac Death,Target Vessel-Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).|0 to 7 days (In-hospital)|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
666357|NCT01759290|Secondary|Major Adverse Cardiac Event (MACE)|MACE includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).|0 to 7 days (In-hospital)|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
666358|NCT01759290|Secondary|Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF)|Target Vessel Failure (TVF) includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Vessel Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).|0 to 7 days (In-hospital)|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
666359|NCT01759290|Secondary|All Death, All MI, All Revascularization (DMR)||0 to 7 days (In-hospital)|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
666360|NCT01759290|Secondary|Late Scaffold Thrombosis||31 to 365 Days|Analysis population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any Scaffold Thrombosis event.||percentage of participants|||Number
666414|NCT01757561|Secondary|the Change in the Level of Serum BDNF(Brain-derived Neurotrophic Factor ) Between Propofol and Sevoflurane Anesthesia||before anesthesia, after extubation ,1day after operation||||||
666363|NCT01759290|Secondary|Acute Success: Clinical Procedure Success (Per Subject Analysis)|Procedure success was defined as the achievement of a final in-scaffold diameter stenosis of <50% by online quantitative coronary angiography (QCA) or visual estimation using Absorb BVS, with or without any adjunctive devices, and without the occurrence of cardiac death, target vessel MI (Q-wave and non-Q-wave MI), or repeat revascularization of the target lesion within 3 days of the index procedure.|During the hospital stay with a maximum of 3 days post index procedure|||percentage of participants||95% Confidence Interval|Number
666364|NCT01759290|Secondary|Acute Success: Clinical Device Success (Lesion Level Analysis)|Device success was defined as the achievement of a final in-scaffold residual diameter stenosis of <50% assessed by online quantitative angiography or visual estimation, using Absorb BVS and without a device deficiency. A device was considered to have failed if it did not meet the requirements of the definition for clinical device success.|< or = 1 day|||percentage of lesions|Participants|95% Confidence Interval|Number
666365|NCT01759290|Primary|Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF))|Target Lesion Failure includes Cardiac Death,Target Vessel-Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).|0 to 407 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
666366|NCT01759264|Secondary|Percentage of Participants With Clinical Response (CR) Due to Adalimumab Treatment|CR70 and CR100 was a decrease from baseline (Week 0) in CDAI score of 70 and 100 or more points, respectively, a lower score indicating improvement in disease activity.|At Week 4, 8, and 12|Intention-to-treat (ITT) population (Participants who received at least one adalimumab induction treatment and were measured for at least one primary endpoint after baseline) and Per-Protocol (PP) population (ITT participants who met inclusion/exclusion criteria and completed the study without any major protocol deviation).||Percentage of participants|||Number
666367|NCT01759264|Secondary|Percentage of Participants With Remission of Crohn's Disease|Crohn's Disease Activity Index (CDAI) was a composite index consisting of a weighted scoring of eight disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600, a higher score indicates increased disease severity. Clinical remission was defined as CDAI score less than 150.|At Week 4, 8, and 12|Intention-to-treat (ITT) population (Participants who received at least one adalimumab induction treatment and were measured for at least one primary endpoint after baseline) and Per-Protocol (PP) population (ITT participants who met inclusion/exclusion criteria and completed the study without any major protocol deviation).||Percentage of participants|||Number
666368|NCT01759264|Secondary|Mean Percent Change of Fecal Calprotectin From Baseline|Fecal calprotectin was monitored as a non-invasive surrogate marker measured by enzyme-linked immunosorbent assays. A stool sample was collected at baseline (Week 0) and every follow up visit.|Week 4, 8, and 12|Intention-to-treat (ITT) population (Participants who received at least one adalimumab induction treatment and were measured for at least one primary endpoint after baseline) and Per-Protocol (PP) population (ITT participants who met inclusion/exclusion criteria and completed the study without any major protocol deviation).||Percentage||Standard Deviation|Mean
666369|NCT01759264|Primary|Percentage of Participants With Fecal Calprotectin Less Than 150 Microgram/Gram|Fecal calprotectin was monitored as a non-invasive surrogate marker measured by enzyme-linked immunosorbent assays. A stool sample was collected at baseline (Week 0) and every follow up visit.|At Week 4|Intention-to-treat (ITT) population (Participants who received at least one adalimumab induction treatment and were measured for at least one primary endpoint after baseline) and Per-Protocol (PP) population (ITT participants who met inclusion/exclusion criteria and completed the study without any major protocol deviation).||Percentage of participants|||Number
666370|NCT01759264|Secondary|Percentage of Participants With Fecal Calprotectin Less Than 150 Microgram/Gram|Fecal calprotectin was monitored as a non-invasive surrogate marker measured by enzyme-linked immunosorbent assays. A stool sample was collected at baseline (Week 0) and every follow up visit.|At Week 8 and 12|Intention-to-treat (ITT) population (Participants who received at least one adalimumab induction treatment and were measured for at least one primary endpoint after baseline) and Per-Protocol (PP) population (ITT participants who met inclusion/exclusion criteria and completed the study without any major protocol deviation).||Percentage of participants|||Number
666371|NCT01759251|Secondary|Clinical Response as Improvement of Vertigo Associated Symptoms Evaluated by Patient|vertigo associated symptoms: tinnitus, hearing loss, nausea, vomiting, faintness and headache; determined with a four-point-scale, where 4 = excellent, 3 = good, 2 = fair, and 1 = poor.|up to 2 months||||||
666372|NCT01759251|Secondary|Clinical Response as Improvement of Vertigo Associated Symptoms Evaluated by Physician|vertigo associated symptoms: tinnitus, hearing loss, nausea, vomiting, faintness and headache; determined with a four-point-scale, where 4 = excellent, 3 = good, 2 = fair, and 1 = poor.|up to 2 months||||||
666373|NCT01759251|Secondary|Overall Clinical Response Assessed by Patient|determined with a four-point-scale, where 4 = excellent, 3 = good, 2 = fair, and 1 = poor.|up to 2 months||||||
666374|NCT01759251|Secondary|Overall Clinical Response Assessed by Physician|determined with a four-point-scale, where 4 = excellent, 3 = good, 2 = fair, and 1 = poor.|up to 2 months||||||
666375|NCT01759251|Secondary|Change of Vestibular Vertigo Attacks Frequency From the End of Observational Treatment Period to the End of Follow-up Period||From 2 months to 4 months||||||
666376|NCT01759251|Secondary|Change of Vestibular Vertigo Attacks Frequency From Baseline to the End of Observational Treatment Period||From Day 0 to 2 months||||||
666377|NCT01759251|Secondary|Change of the Patient’s Clinical Conditions of Vestibular Vertigo From Baseline to the End of Observational Treatment Period|determined with the Scale for Vestibular Vertigo Severity Level and Clinical Response Evaluation (SVVSLCRE)|From Day 0 to 2 months||||||
666378|NCT01759251|Primary|Scale for Vestibular Vertigo Severity Level and Clinical Response Evaluation (SVVSLCRE)|Number of patients with clinical response on treatment determined with SVVSLCRE|Up to 2 months|60 days treatment group||participants|||Number
666379|NCT01759160|Secondary|CVP (Central Venous Pressure)|CVP was continuously monitored to assess preload condition and served to calculate SVRI (systemic vascular resistance index) every minute during the first 25 minutes of infusion.|25 minutes after induction||||||
666380|NCT01759160|Secondary|NI (Narcotrend Index) Reduction|Narcotrend was utilized to continuously record patients' sedation level during induction, provided as a criteria for Cpt (Plasma Target Concentration) adjustment.|25 minutes after propofol infusion||||||
666381|NCT01759160|Primary|SVI (Stroke Volume Index) Value Change From Baseline Level at the End of the First 25 Minutes.|After propofol infusion started, according to sedation level, TCI targets were gradually titrated to reach a state of equilibrium at the end of the first 25 minutes. SVI were continuously monitored, at the end of the first 25 minutes, value change from baseline level were calculated.|The end of the first 25 minutes after propofol infusion|||ml/beat/m^2||Standard Deviation|Mean
666382|NCT01758900|Secondary|Complication Rate||Within 1 week after all the examinations are finished|||participants|||Number
666383|NCT01758900|Secondary|Abdominal Circumference|To measure abdominal circumference, a tape was placed horizontally around the abdomen at the level of the middle location between the level of anterior superior iliac spine and the lower edge of costal arch, and the measurement was made at the end of a normal expiration before and after the procedure.|10 minutes before/after the examination|||centimeter||Standard Deviation|Mean
666384|NCT01758900|Secondary|Procedure Time||Within 5 minutes after the examination|||minutes||Standard Deviation|Mean
666385|NCT01758900|Secondary|Patient's Acceptability|Acceptability was recorded on a questionnaire given to patients after the examination. Patients assessed the degree of abdominal pain/distention along a 10-cm line of the VAS(visual analogue scale), with the 0-cm point labeled “no pain/distention” on left end and the 10-cm point labeled “very severe pain/distention that cannot be tolerated” on the right end. Patients were asked to score the severity of pain/distention experienced at 1, 2, 3 and 6 hours after the completion of the entire examination.|6 hours after the examination|||participants|||Number
666386|NCT01758900|Secondary|Diagnostic Rate||Within 1 week after all the examinations are finished|||Percentage of Participants|||Number
666387|NCT01758900|Secondary|Total Enteroscopy Rate||Within 1 week after all the examinations are finished|||participants|||Number
666388|NCT01758900|Primary|Intubation Depth||Within 5 minutes after the examination|||cm||Standard Deviation|Mean
666389|NCT01758289|Secondary|Beck Depression Inventory (BDI) Scores At Baseline and Final Study Visit|BDI is a 21-item questionnaire, participant self-report rating inventory that measures characteristic attitudes and symptoms of depression. The range of scores is 0 to 63, with a higher value representing a worse outcome.|Baseline Week 1 (Study Visit 1), Week 24 (Final Study Visit)|Participants with a complete, valid assessment at given time point.||units on a scale||Standard Deviation|Mean
666390|NCT01758289|Secondary|European Quality of Life 5 Dimensions (EQ-5D) Visual Analogue Scale (VAS) Scores At Baseline, Week 12, and Week 24|The EQ-5D questionnaire is an international, standardized, generic instrument for describing and valuing health status that is divided into 5 parameters that include mobility, self-care, usual activities, pain/discomfort, anxiety/depression and a VAS. For the VAS portion, health status is assessed by participants on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'worst imaginable health state' (0) and 'best imaginable health state' (100).|Baseline Week 1 (Study Visit 1), Week 12 (Study Visit 3), Week 24 (Final Study Visit)|Participants with valid assessments at given time point.||units on a scale||Standard Deviation|Mean
666391|NCT01758289|Secondary|European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24|The EQ-5D questionnaire is an international, standardized, generic instrument for describing and valuing health status that is divided into 5 parameters that include mobility, self-care, usual activities, pain/discomfort, anxiety/depression and a visual analogue scale (VAS). For each parameter other than the VAS, participants are asked to indicate which of 5 statements (from ‘no problem’ to ‘extreme problem’) best describes their health state.|Baseline Week 1 (Study Visit 1), Week 12 (Study Visit 3), Week 24 (Final Study Visit)|Participants with valid assessments at given time point.||participants|||Number
666392|NCT01758289|Secondary|Number of Participants Achieving PTH Level Reductions to < 300 pg/mL or 30% Below Baseline in 12 or 24 Weeks|Number of participants achieving PTH level reductions to < 300 pg/mL or 30% below Baseline in 12 weeks (Baseline to Week 12 or Week 12 to Week 24) or in 24 weeks (Baseline to Week 24).|Baseline Week 1 (Study Visit 1) to Week 24 (Final Study Visit)|All participants; n=number of participants with valid PTH values at given time point.||participants|||Number
666393|NCT01758289|Secondary|Number of Participants Achieving Parathyroid Hormone (PTH) Levels < 300 pg/mL|Participants who achieved PTH Levels < 300 pg/mL between the first and third study visit (Baseline to Week 12) and the third and final study visit (Week 12 to Week 24).|Baseline to Week 12, Week 12 to Week 24|All participants; n=participants with valid PTH values at given time point.||participants|||Number
666394|NCT01758289|Secondary|Percentage of Participants With Hypercalcemia, Hyperphosphatemia and Elevations of Calcium-Phosphate Product (Ca x P) at Baseline, Week 12, and Week 24|"Hypercalcemia was defined as a value of serum calcium (Ca) greater than or equal to 10.3 mg/dL.
Hyperphosphatemia was defined as a value of serum phosphorus (P) greater than or equal to 5.5 mg/dL.
Elevated Ca×P was defined as as greater or equal to 56.65 mg^2/dL^2, calculated as the result of multiplying the maximum values of calcium (10.3 mg/dL) and phosphorus (5.5 mg/dL)."|Baseline Week 1 (Study Visit 1), Week 12 (Study Visit 3), Week 24 (Final Study Visit)|Participants with valid assessments at given time point.||percentage of participants|||Number
666395|NCT01758289|Primary|Percentage of Participants Achieving at Least a 30% Reduction From Baseline in the Levels of Parathyroid Hormone (PTH) at the Final Study Visit||Baseline Week 1 (Study Visit 1) to Week 24 (Final Study Visit)|Participants with valid PTH values at Baseline and Final Study Visit.||percentage of participants|||Number
666410|NCT01757691|Primary|Mean Retinal Nerve Fiber Layer (RNFL) Thinning in Patients Treated With Fingolimod 0.5mg/Day, Relative to Patients Treated With Placebo|Due to early termination and low patient enrollment the primary outcome measure was not analyzed|Baseline and Week 18||||||
666411|NCT01757561|Other Pre-specified|Blood Gas Analysis|including artery blood and blood from jugular vein bulb|baseline,every hour in the operation,after extubation||||||
666412|NCT01757561|Other Pre-specified|Vital Signs|heart rate, artery blood pressure,pulse oxygen saturation,temperature|baseline , evey hour in the operation,afte extubation||||||
666396|NCT01757964|Primary|Number of Participants Who Responded to Stool Translplantation By 2 Weeks as Determined by Pediatric Ulcerative Colitis Activity Index (PUCAI)/Pediatric Crohn's Disease Activity Index (PCDAI) Scoring|The primary outcome measure is based on estimating the responder rate. This is defined as the proportion of patients with response to therapy by a drop of 10 or more points in PUCAI/PCDAI scoring. PUCAI/PCDAI are validated activity indexes for pediatric Ulcerative colitis and Crohn's disease, respectively. PUCAI scoring ranges from 0 to 85, with disease remission less than 10, mild disease activity between 10 - 35, moderate disease activity from 35 - 65, and severe disease activity above 65. PCDAI scoring ranges from 0 to 100; with remission being less than 10, mild disease from 10 to 30, and moderate to severe disease greater than 30.|2 weeks|||participants|||Number
666397|NCT01757847|Secondary|Change From Baseline in The Obesity-related Well Being Scale (ORWELL-97) at 4 Weeks, 3 Months, and 6 Months|The ORWELL-97 is a self-report measure of obesity-related quality of life. It has been validated on obese patients. The total score ranges from 0-162 with higher scores indicating lower quality of life and decreasing scores indicating improvement in the outcome.|post treatment (4 weeks), 3 months, 6 months|Participants with measurement at baseline and at least one other time point.||units on a scale||Standard Deviation|Mean
666398|NCT01757847|Primary|Change From Baseline in Binge Eating Scale (BES) at 4 Weeks, 3 Months and 6 Months|This measure contains 16 questions that describe both behavioral and emotional manifestations of a binge episode. This scale was specifically developed to assess binge eating severity and associated emotional distress in overweight and obese individuals. The total score for the measure ranges from 0-46 points with higher scores indicating greater problems with binge eating and lower scores indicating better outcome.|post treatment (4 weeks), 3 months, 6 months|participants with measurement at baseline and at least one other time point.||units on a scale||Standard Deviation|Mean
666399|NCT01757704|Primary|Duration of the De-airing Procedure|The de-airing procedure is deemed completed when the Trans-esophageal Echocardiography (TEE) no longer visualizes air emboli in the heart Chambers. The duration is likely to vary between individuals and reflects the complexity of the de-airing procedure.|Time from release of aortic crossclamp to finished de-airing|||Minutes||Inter-Quartile Range|Median
666400|NCT01757704|Primary|Participants With <=Grade I Air Emboli as Assessed by Trans-esophageal Echocardiography (TEE) After Finished De-airing.|The severity of residual air emboli in three anatomic areas; left atrium, left ventricle and aortic root, is assessed by Trans-esophageal Echocardiography (TEE) and classified in grade 0-3 as follows, Grade o: no residual air; grade I: gas emboli detected in one of three anatomic areas during one cardiac cycle; grade II: gas emboli detected simultaneously in two of three anatomic areas during one cardiac cycle; grade III: gas emboli detected simultaneously in all three anatomic areas during one cardiac cycle.|6-10 minutes after finished de-airing|||Participants|||Number
666401|NCT01757704|Primary|Participants With <=Grade I Air Emboli as Assessed by Trans-esophageal Echocardiography (TEE) After Finished De-airing.|The severity of residual air emboli in three anatomic areas; left atrium, left ventricle and aortic root, is assessed by Trans-esophageal Echocardiography (TEE) and classified in grade 0-3 as follows, Grade o: no residual air; grade I: gas emboli detected in one of three anatomic areas during one cardiac cycle; grade II: gas emboli detected simultaneously in two of three anatomic areas during one cardiac cycle; grade III: gas emboli detected simultaneously in all three anatomic areas during one cardiac cycle.|3-6 minutes after finished de-airing|||Participants|||Number
666402|NCT01757704|Primary|Participants With <=Grade I Air Emboli as Assessed by Trans-esophageal Echocardiography (TEE) After Finished De-airing.|The severity of residual air emboli in three anatomic areas; left atrium, left ventricle and aortic root, is assessed by Trans-esophageal Echocardiography (TEE) and classified in grade 0-3 as follows, Grade o: no residual air; grade I: gas emboli detected in one of three anatomic areas during one cardiac cycle; grade II: gas emboli detected simultaneously in two of three anatomic areas during one cardiac cycle; grade III: gas emboli detected simultaneously in all three anatomic areas during one cardiac cycle.|0-3 minutes after finished de-airing|||Participants|||Number
666403|NCT01757704|Primary|Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery|Cerebral air emboli will be assessed quantitatively by On-line counting of gaseous microembolic signals (MES) by Trans-cranial Echo-Doppler (TCD) monitoring of the right and left middle cerebral artery. The sum of the gaseous microembolic signals registered from the right and left middle cerebral artery will be reported.|Period of ten minutes after finished de-airing|||Air microemboli||Inter-Quartile Range|Median
666404|NCT01757704|Primary|Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery|Cerebral air emboli will be assessed quantitatively by On-line counting of gaseous microembolic signals (MES) by Trans-cranial Echo-Doppler (TCD) monitoring of the right and left middle cerebral artery. The sum of the gaseous microembolic signals registered from the right and left middle cerebral artery will be reported.|Time from cardiac ejection to finished de-airing, an average of 5-10 minutes|||Air microemboli||Inter-Quartile Range|Median
666405|NCT01757704|Primary|Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery|Cerebral air emboli will be assessed quantitatively by On-line counting of gaseous microembolic signals (MES) by Trans-cranial Echo-Doppler (TCD) monitoring of the right and left middle cerebral artery. The sum of the gaseous microembolic signals registered from the right and left middle cerebral artery will be reported.|Time from the release of the aortic crossclamp to cardiac ejection, an average of 10-15 minutes|||Air microemboli||Inter-Quartile Range|Median
666406|NCT01757691|Secondary|Number of Particpants With Adverse Events as a Measure of Safety and Tolerability|Number of particpants with Adverse events as a measure of safety and tolerability|Weeks 0, 4, 8, 12, 18, 24, 36, 48, 60|Safety population consited of all patients who received at least one dose of study medication||Participants|||Number
666407|NCT01757691|Secondary|Proportion of Paatients Converting to Either 2005 or 2010 McDonald MS or to CDMS|Due to early termination and low patient enrollment this trial was not powered for efficacy|Baseline, Week 18, Week 48||||||
666408|NCT01757691|Secondary|Vision Based Quality of Life (QoL) Utility Score|Due to early termination and low patient enrollment this trial was not powered for efficacy|Baseline, Week 18, Week 48||||||
666409|NCT01757691|Secondary|Low Contrast Visual Acuity (LCVA)|Due to early termination and low patient enrollment this trial was not powered for efficacy|Baseline, Week 48||||||
666413|NCT01757561|Secondary|the Change in the Level of Serum s-100β Between Propofol and Sevoflurane Anesthesia||before anesthesia,after extubation,1 day after operation||||||
666415|NCT01757561|Secondary|the Incidence of Postoperative Cognitive Disfunction(POCD)Between Propofol and Sevoflurane General Anesthesia|The incidence of early POCD was recorded. The MMSE score and the Montreal cognitive assessment (MoCA) score were recorded 1day before surgery, 1-3 day after surgery and 5-7 day after surgery. The POCD was defined as MMSE score illiterate group ≤ 17, primary and secondary school group ≤ 20, junior high school and above group ≤ 24，or the MoCA score decreased 20% with the baseline.|1-3days、5-7days after operation|||participants|||Number
666416|NCT01757561|Primary|the Incidence of Intraoperative Desaturation Between Propofol and Sevoflurane General Anesthesia|SjvO2 were measured before anesthesia, after intubation, every hour during operation, after extubation by jugular vein blood and atrial blood gas analysis.The incidence of intraoperative cerebral desaturation was recorded when SjvO2<50%.|baseline ,every hour in the operation period,after extubation|||participants|||Number
666423|NCT01757275|Secondary|Number of Blood Units Transfused Within 30 Days||within 30 days|FAS||blood units|||Number
666424|NCT01757275|Secondary|Number of Blood Units Transfused Within 72 Hours||within 72 hours|FAS||blood units|||Number
666425|NCT01757275|Secondary|Number of Patients With Surgery Due to Rebleeding Within 30 Days||within 30 days|FAS||participants|||Number
666426|NCT01757275|Secondary|Number of Patients With Surgery Due to Rebleeding Within 72 Hours||within 72 hours|FAS||participants|||Number
666427|NCT01757275|Secondary|Number of Patients With Endoscopic Re-treatment Within 30 Days||30 days|FAS||participants|||Number
666428|NCT01757275|Secondary|Number of Patients With Endoscopic Re-treatment Within 72 Hours||72 hours|FAS||participants|||Number
666429|NCT01757275|Secondary|Rate of Clinically Significant Rebleeding During 30 Days|"Diagnostic criteria for clinically significant rebleeding based on either A, B or C:
A) Endoscopy – initiated by clinical signs of bleeding defined as one of B1 or B2 or B3 and endoscopic verification, ie one of A1 or A2.
A1: Blood in stomach (this criteria cannot be used during the first 6 hours after primary endoscopic haemostasis). A2: A verified active bleeding from a peptic ulcer (Forrest Ia, Ib).
B) A true clinically based definition, at least two of B1 and/or B2 and/or B3. B1: Vomiting of fresh blood or fresh blood in a gastric tube or haematochezia or melaena after a normal stool. B2: Decrease in Hb >20g/L (or Hct >6%) during 24 hours or an increase in Hb <10g/L (or Hct <3%) despite ≥2 units of blood has been transfused during 24hours. B3: Unstable circulation systolic blood pressure ≤ 90 mmHg or pulse ≥110/min (after have had a stable circulation).
C) Haematemesis. Vomiting significant amounts (>200 ml) of fresh blood as estimated by the investigator."|30 days|FAS||participants|||Number
666444|NCT01757184|Primary|Percentage of Subjects Achieving Alanine Aminotransferase (ALT) Normalization|The primary efficacy endpoint was the percentage of subjects who achieve alanine aminotransferase (ALT) normalization (i.e., ALT below the age- and gender-specific upper limit of normal provided by the central laboratory performing the assay) at the end of the double-blind treatment period (i.e., the last double-blind assessment), relative to placebo.|Baseline to the end of the double-blind period (week 20)|All subjects in the Full Analysis Set (defined as subjects receiving at least one dose of study drug) who had an abnormal ALT level at baseline.||percentage of subjects|||Number
666445|NCT01756976|Primary|Washed RBC Hematocrit|The Hematocrit of the RBC shall be > 50%.|< 4 hours|||percentage of HcT||Standard Deviation|Mean
666430|NCT01757275|Secondary|Rate of Clinically Significant Rebleeding During 7 Days|"Diagnostic criteria for clinically significant rebleeding based on either A, B or C:
A) Endoscopy – initiated by clinical signs of bleeding defined as one of B1 or B2 or B3 and endoscopic verification, ie one of A1 or A2.
A1: Blood in stomach (this criteria cannot be used during the first 6 hours after primary endoscopic haemostasis). A2: A verified active bleeding from a peptic ulcer (Forrest Ia, Ib).
B) A true clinically based definition, at least two of B1 and/or B2 and/or B3. B1: Vomiting of fresh blood or fresh blood in a gastric tube or haematochezia or melaena after a normal stool. B2: Decrease in Hb >20g/L (or Hct >6%) during 24 hours or an increase in Hb <10g/L (or Hct <3%) despite ≥2 units of blood has been transfused during 24hours. B3: Unstable circulation systolic blood pressure ≤ 90 mmHg or pulse ≥110/min (after have had a stable circulation).
C) Haematemesis. Vomiting significant amounts (>200 ml) of fresh blood as estimated by the investigator."|7 days|FAS||participants|||Number
666431|NCT01757275|Primary|Rate of Clinically Significant Rebleeding Within 72 Hours|"Diagnostic criteria for clinically significant rebleeding based on either A, B or C:
A) Endoscopy – initiated by clinical signs of bleeding defined as one of B1 or B2 or B3 and endoscopic verification, ie one of A1 or A2.
A1: Blood in stomach (this criteria cannot be used during the first 6 hours after primary endoscopic haemostasis). A2: A verified active bleeding from a peptic ulcer (Forrest Ia, Ib).
B) A true clinically based definition, at least two of B1 and/or B2 and/or B3. B1: Vomiting of fresh blood or fresh blood in a gastric tube or haematochezia or melaena after a normal stool. B2: Decrease in Hb >20g/L (or Hct >6%) during 24 hours or an increase in Hb <10g/L (or Hct <3%) despite ≥2 units of blood has been transfused during 24hours. B3: Unstable circulation systolic blood pressure ≤ 90 mmHg or pulse ≥110/min (after have had a stable circulation).
C) Haematemesis. Vomiting significant amounts (>200 ml) of fresh blood as estimated by the investigator."|72 hours|Full analysis set (FAS). All randomised patients, who started the randomised iv treatment (bolus dose), were included in the FAS.||participants|||Number
666432|NCT01757197|Secondary|Effect of Toclizumab on Karnofsky Performance Status||1 year||||||
666433|NCT01757197|Secondary|Toclizumab Response in Each Organ||1 year||||||
666434|NCT01757197|Secondary|Disease-free Overall Survival at 100 Days, 6 Months and One Year From the Time of the First Tocilizumab Infusion.|We were unable to evaluate disease-free survival at 100 days, 6 months and one year from the time of the first tocilizumab infusion. All subjects enrolled on this study died before this time point and the study closed to enrollment due to slow accrual.|Approximately 1 year|We were unable to evaluate disease-free survival at 100 days, 6 months and one year from the time of the first tocilizumab infusion. All subjects enrolled on this study died before this time point and the study closed to enrollment due to slow accrual.|||||
666435|NCT01757197|Primary|Number of Subjects With GVHD Who Are Tolerable to Tocilizumab After Having Failed Response to Glucocorticosteroid Treatment|Both subjects enrolled on this study experienced failed response to glucocorticosteroid treatment but were able to tolerate tocilizumab. We were unable to collect extensive data on these 2 subjects because they both died early on in the study due to disease complications.|Day 28|Not evaluable.||Participants|||Count of Participants
666436|NCT01757184|Secondary|Percentage Change From Baseline in Liver Volume|Relative reduction (percentage change from baseline) in liver volume, as assessed by magnetic resonance imaging, in the subset of subjects for whom imaging was performed|Baseline to the end of the double-blind period (week 20)|All subjects in the Full Analysis Set (defined as subjects receiving at least one dose of study drug) who had an MRI assessment of liver volume at baseline and the last time point in the double-blind period.||percentage change from baseline||Standard Deviation|Mean
666437|NCT01757184|Secondary|Number of Subjects With Improvement in Liver Histology (Decrease of >5% in Hepatic Steatosis Score)|The number of subjects who had an improvement in hepatic histology (i.e., a decrease of >5% in hepatic steatosis score) from baseline to Week 20, as determined by blinded central review, in the subset of subjects for whom liver biopsy was performed.|Baseline to the end of the double-blind period (week 20)|||participants w/ improved liver histology|||Number
666438|NCT01757184|Secondary|Percentage Change From Baseline in Liver Fat Content|Decrease in liver fat content, as assessed by magnetic resonance imaging (MRI), in the subset of subjects for whom imaging was performed|Baseline to the end of the double-blind period (week 20)|All subjects in the Full Analysis Set (defined as subjects receiving at least one dose of study drug) who had an MRI assessment of liver fat content at baseline and the last time point in the double-blind period. (Note: liver fat content could only be determined for subjects able to breath-hold for 15-30 seconds, unlike liver volume.)||percentage change from baseline||Standard Deviation|Mean
666439|NCT01757184|Secondary|Percentage Change From Baseline in HDL-c|Relative increase (percentage change from baseline) in high density lipoprotein cholesterol (HDL-c) at the end of the double-blind period|Baseline to the end of the double-blind period (week 20)|||percentage change from baseline||Standard Deviation|Mean
666440|NCT01757184|Secondary|Percentage Change From Baseline in Triglycerides|Relative reduction (percentage change from baseline) in triglycerides at the end of the double-blind period|Baseline to the end of the double-blind period (week 20)|||percentage change from baseline||Standard Deviation|Mean
666441|NCT01757184|Secondary|Percentage of Subjects Achieving Aspartate Aminotransferase (AST) Normalization|The percentage of subjects with an abnormal baseline aspartate aminotransferase (AST; i.e., >ULN) who achieved AST normalization, based on age- and gender-specific normal ranges provided by the central laboratory performing the assay.|Baseline to the end of the double-blind period (week 20)|All subjects in the Full Analysis Set (defined as subjects receiving at least one dose of study drug) who had an abnormal AST level at baseline. (One subject in the placebo group had a normal AST level at baseline and was therefore excluded from this analysis.)||percentage of subjects|||Number
666442|NCT01757184|Secondary|Percentage Change From Baseline in Non-HDL-c|Relative reduction (percentage change from baseline) in non-high density lipoprotein cholesterol (non-HDL-c) at the end of the double-blind period|Baseline to the end of the double-blind period (week 20)|||percentage change from baseline||Standard Deviation|Mean
666443|NCT01757184|Secondary|Percentage Change From Baseline in LDL-c|Relative reduction (percentage change from baseline) in LDL-c at the end of the double-blind period.|Baseline to the end of the double-blind period (week 20)|||percentage change from baseline||Standard Deviation|Mean
666446|NCT01756586|Primary|Increase in the Duration of Block||3 days|Did not have resources to follow up with the subjects after the surgery. The study was terminated early.|||||
666447|NCT01756391|Primary|Maximum Symptom Days/14 Days|"Largest value among the following:
Number of days with wheezing, tightness in the chest, or cough Number of nights with disturbed sleep as a result of asthma Number of days on which the child had to slow down or discontinue play activities because of asthma"|14 days|Those with appropriate follow up and school/home allergen exposure data and allergy sensitization data||days||Standard Deviation|Mean
666448|NCT01756391|Secondary|Exhaled Nitric Oxide Levels||12 months||||||
666449|NCT01756391|Secondary|Percent Change in FEV1 After Short-acting Beta Agonist||12 months||||||
666450|NCT01756391|Secondary|FEV1 Percent Predicted||12 months||||||
666451|NCT01756391|Secondary|FEV1/FVC||12 months||||||
666452|NCT01756391|Secondary|Prednisone Bursts||12 months||||||
666453|NCT01756391|Secondary|Unscheduled Physician/Health Care Visits||12 months||||||
666454|NCT01756391|Secondary|Emergency Department Visits||12 months||||||
666455|NCT01756391|Secondary|Emergency Department Visits||12 months||||||
666456|NCT01756391|Secondary|Number of Hospitalizations||12 months||||||
666457|NCT01756391|Secondary|Nights of Wakening Due to Asthma Symptoms||12 months||||||
666458|NCT01756391|Secondary|Days of Cough Without an Upper Respiratory Infection||12 months||||||
666459|NCT01756391|Secondary|Days of Exercise-induced Symptoms||12 months||||||
666460|NCT01756391|Secondary|Days of Slowed Activity Due to Asthma||12 months||||||
666461|NCT01756300|Secondary|Incidence of Subjects Achieving at Least 10 mmHg Systolic Blood Pressure Reduction From Baseline at 1, 3, 6, and 12 Month Post-procedure|This endpoint is defined as Incidence of subjects achieving at least 10 mmHg systolic blood pressure reduction from Baseline at 1, 3, 6, and 12 month post-procedure|At 1, 3, 6, and 12 month post-procedure|The Effectiveness analysis population, which consists of all enrolled subjects who have had technical success without major protocol deviations. Technical Success is defined to be when the investigational catheter has been successfully inserted into the femoral artery and RF energy is successfully applied in at least one artery. .||percentage of participants|||Number
666462|NCT01756300|Secondary|Incidence of Subjects Achieving Target Systolic Blood Pressure at 1, 3, 6, and 12 Month Post-procedure|This endpoint is defined as incidence of subjects achieving target systolic blood pressure at 1, 3, 6, and 12 month post-procedure. Target systolic blood pressure is defined as less than 140 mmHg (and less than 130 mmHg for Type II Diabetics).|At 1, 3, 6, and 12 month post-procedure|The Effectiveness analysis population, which consists of all enrolled subjects who have had technical success without major protocol deviations. Technical Success is defined to be when the investigational catheter has been successfully inserted into the femoral artery and RF energy is successfully applied in at least one artery. .||percentage of participants|||Number
666463|NCT01756300|Secondary|Actual and Change in 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 3, 6 and 12 Months Post Procedure|This secondary effectiveness endpoint is defined as change in 24-hour ABPM systolic blood pressure and diastolic blood pressure from baseline to 3, 6 and 12 months post procedure. The blood pressures were measured using the 24-hour Ambulatory Blood Pressure Monitoring system. Reported values are the arithmetic mean of collected blood pressure values over 24 hours. Negative values represent reduction from baseline.|From baseline to 3, 6 and 12 months post procedure|The Effectiveness analysis population, which consists of all enrolled subjects who have had technical success without major protocol deviations. Technical Success is defined to be when the investigational catheter has been successfully inserted into the femoral artery and RF energy is successfully applied in at least one artery. .||mmHg||Standard Deviation|Mean
666464|NCT01756300|Secondary|Actual and Change in Office Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 1 ,3, 6 and 12 Months Post Procedure|This secondary effectiveness endpoint is defined as actual and change in office systolic blood pressure and diastolic blood pressure from baseline to 1 ,3, 6 and 12 months post procedure. Negative values represent reduction from baseline.|From baseline to 1 ,3, 6 and 12 months post procedure|The Effectiveness analysis population, which consists of all enrolled subjects who have had technical success without major protocol deviations. Technical Success is defined to be when the investigational catheter has been successfully inserted into the femoral artery and radiofrequency (RF) energy is successfully applied in at least one artery. .||mmHg||Standard Deviation|Mean
666465|NCT01756300|Secondary|Subjects Experienced Any Adverse Cardiovascular and Renal Events Through 12 Months Post-procedure|These adverse events include renal artery stenosis (≥60% diameter reduction confirmed by MRI or renal angiography); periprocedural renal artery dissection or perforation requiring intervention, serious arterial access site related complications requiring intervention or prolonging hospitalization; ≥25% reduction between baseline and 12 months in renal function measured by the estimated Glomerular Filtration Rate (eGFR), as well as composite of major adverse cardiovascular and/or renal events.|12 months post-procedure|The Safety Analysis population, which consists of all enrolled subjects who have undergone insertion of the study ablation catheter.||percentage of participants|||Number
666466|NCT01756300|Primary|The Incidence of Major Cardiovascular and/or Renal Adverse Events Related to the Renal Denervation Procedure That Occurred Within 30 Days Post-procedure.|The major adverse events include Acute myocardial infarction, Death from progressive heart failure, death from aortic or peripheral artery disease, from renal failure and sudden cardiac death, New-onset heart failure, Stroke, Aortic or lower limb, revascularization procedure, Lower limb amputation, Beginning dialysis, Hospital admission for hypertensive emergency unrelated to non-adherence or non-persistence with drugs at each follow up visit, Hospitalization for atrial fibrillation.|30 days post-procedure|The Safety Analysis population, which consists of all enrolled subjects who have undergone insertion of the study ablation catheter.||percentage of participants|||Number
666475|NCT01756235|Secondary|Correlation Between Physical Activity (Total SQUASH Score and Individual Physical Activity Categories’ SQUASH Scores) and HAQ-DI Scores|The SQUASH and its subscores are instruments to measure the physical activity level, whereas the HAQ-DI measures physical functioning. In order to evaluate the relationship between physical function and physical activity (as measured by the both scales), Pearson correlation coefficients were calculated for the SQUASH scores and the HAQ-DI. A decrease in physical functioning is likely to prohibit physical activity.|Month 0 and Month 12 LOCF|Analysis included all participants who received at least one dose of adalimumab with evaluable data.||Correlation coeficient|||Number
666467|NCT01756274|Other Pre-specified|Number of Blood Samples From Babies in the Neonatal Intensive Care Unit (NICU) That Produced Meter Results Beyond What Random Chance Would Predict (i.e., Outside 95% Limits for Studentized Residuals)|To evaluate how the meter systems perform with blood samples drawn in the Neonatal Intensive Care Unit, the number of blood samples that produced unusual meter results out of the total number of blood samples that came from babies in Neonatal Intensive Care was reported. Studentized residuals were used to measure the degree to which meter BG results departed from what would be expected using a linear model. (This analysis is not related to BGM accuracy status, which has already been reported.)|30 minutes|Of 217 'left-over' blood samples, 211(217-6) were included in data analysis and, of these, thirty (30) blood samples were obtained from babies in the Neonatal Intensive Care Unit (NICU).||BLOOD SAMPLES|BLOOD SAMPLES From Babies in the NICU||Number
666468|NCT01756274|Other Pre-specified|Number of Blood Samples From Babies Less Than 24 Hours Old That Produced Meter Results Beyond What Random Chance Would Predict (i.e. Outside 95% Limits for Studentized Residuals)|To evaluate the effect of neonatal age on the meter systems' performances, the number of blood samples that produced unusual meter results out of the total number of blood samples that came from babies less than 24 hours old was reported. Studentized residuals were used to measure the degree to which meter BG results departed from what would be expected using a linear model. (This analysis is not related to BGM accuracy status, which has already been reported.)|30 minutes|Of 217 'left-over' blood samples, 211(217-6) were included in data analysis. Of these, twenty five (25) blood samples were obtained from babies that were less than 24 hours old.||BLOOD SAMPLES|BLOOD SAMPLES From Babies <24 hours old||Number
666469|NCT01756274|Secondary|Percent of BG Results (Per Population) Within +/-15 mg/dL (<100 mg/dL)and Within +/-15% (>=100 mg/dL) of the Reference Instrument BG Value|Laboratory professionals tested the BG concentration of 'left-over samples' using plasma referenced Blood Glucose Monitoring Systems. BGMS results were compared with capillary plasma BG results obtained with a Cobas® 6000 instrument (Roche Diagnostics Corp., Indianapolis, IN).|30 minutes|Each subject could contribute up to 2 blood samples. Of 217 blood samples 211(217-6) were included in data analysis. Two samples could not be used because they had been taken from sources that had not been specified in the protocol. Four samples had no reference method results due to laboratory errors.||percentage of BLOOD GLUCOSE RESULTS|BLOOD SAMPLES||Number
666470|NCT01756274|Primary|Percent of Blood Glucose Results Within +/-15 mg/dL(<75 mg/dL) and Within +/-20% (>=75 mg/dL) of the Reference Instrument BG Value|Laboratory professionals tested the BG concentration of 'left-over samples' using plasma referenced Blood Glucose Monitoring Systems. BGMS results were compared with capillary plasma BG results obtained with a Cobas® 6000 instrument (Roche Diagnostics Corp., Indianapolis, IN).|30 minutes|Each subject could contribute up to 2 blood samples. Of 217 blood samples 211(217-6) were included in data analysis. Two samples could not be used because they had been taken from sources that had not been specified in the protocol. Four samples had no reference method results due to laboratory errors.||percentage of Blood Glucose Results|Blood Samples||Number
666471|NCT01756235|Secondary|Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories’ SQUASH Scores) Influenced by Occupation|The quantitative SQUASH score (scores range from 0 to 17010.000) is calculated as the sum of subscores that capture physical activity related to commuting activities (SQUASH-A), scores range from 0 to 4082.400, leisure time activities (SQUASH-B), scores range from 0 to 6123.600, household activities (SQUASH-C), scores range from 0 to 3402.000, and activity at work and school (SQUASH-D), scores range from 0 to 3402.000. The SQUASH score and its subscores has non-negative values. Higher values indicate a higher individual activity level.|Month 0 and Month 12 LOCF|Analysis included all participants who received at least one dose of adalimumab with evaluable data.||units on a scale||Standard Deviation|Mean
666472|NCT01756235|Secondary|Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories’ SQUASH Scores) Influenced by Education|The quantitative SQUASH score (scores range from 0 to 17010.000) is calculated as the sum of subscores that capture physical activity related to commuting activities (SQUASH-A), scores range from 0 to 4082.400, leisure time activities (SQUASH-B), scores range from 0 to 6123.600, household activities (SQUASH-C), scores range from 0 to 3402.000, and activity at work and school (SQUASH-D), scores range from 0 to 3402.000. The SQUASH score and its subscores has non-negative values. Higher values indicate a higher individual activity level.|Month 0 and Month 12 LOCF|Analysis included all participants who received at least one dose of adalimumab with evaluable data.||units on a scale||Standard Deviation|Mean
666473|NCT01756235|Secondary|Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories’ SQUASH Scores) Influenced by Gender|The quantitative SQUASH score (scores range from 0 to 17010.000) is calculated as the sum of subscores that capture physical activity related to commuting activities (SQUASH-A), scores range from 0 to 4082.400, leisure time activities (SQUASH-B), scores range from 0 to 6123.600, household activities (SQUASH-C), scores range from 0 to 3402.000, and activity at work and school (SQUASH-D), scores range from 0 to 3402.000. The SQUASH score and its subscores has non-negative values. Higher values indicate a higher individual activity level.|Month 0 and Month 12 LOCF|Analysis included all participants who received at least one dose of adalimumab with evaluable data.||units on a scale||Standard Deviation|Mean
666474|NCT01756235|Secondary|Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories’ SQUASH Scores) Influenced by Age Categories|The quantitative SQUASH score (scores range from 0 to 17010.000) is calculated as the sum of subscores that capture physical activity related to commuting activities (SQUASH-A), scores range from 0 to 4082.400, leisure time activities (SQUASH-B), scores range from 0 to 6123.600, household activities (SQUASH-C), scores range from 0 to 3402.000, and activity at work and school (SQUASH-D), scores range from 0 to 3402.000. The SQUASH score and its subscores has non-negative values. Higher values indicate a higher individual activity level.|Month 0 and Month 12 LOCF|Analysis included all participants who received at least one dose of adalimumab with evaluable data.||units on a scale||Standard Deviation|Mean
666484|NCT01756235|Secondary|Mean Change From Baseline in SQUASH-C Scores|SQUASH subscores capture physical activity. SQUASH-C subscore captures house-hold activities, with scores ranging from 0 to 3402.000. The SQUASH subscores have non-negative values. Higher values indicate a higher individual activity level.|Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF|Analysis included all participants who received at least one dose of adalimumab with evaluable data.||units on a scale||Standard Deviation|Mean
666476|NCT01756235|Secondary|Correlation Between Physical Activity (Total SQUASH Score and Individual Physical Activity Categories’ SQUASH Scores) and DAS28 Scores|The SQUASH and its subscores are instruments to measure the physical activity level, whereas the DAS28 measures disease activity. In order to evaluate the relationship between physical function and disease activity (as measured by the two scales), Pearson correlation coefficients were calculated for the SQUASH scores and the DAS28. A decrease in physical functioning is likely to be connected to stronger disease activity.|Month 0 and Month 12 LOCF|Analysis included all participants who received at least one dose of adalimumab with evaluable data.||Correlation coeficient|||Number
666477|NCT01756235|Secondary|Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score|The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores range from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from baseline in the overall score indicates improvement.|Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF|Analysis included all participants who received at least one dose of adalimumab with evaluable data.||units on a scale||Standard Deviation|Mean
666478|NCT01756235|Secondary|Mean Change From Baseline in Total Physical Activity SQUASH Scores and Individual Physical Activity Categories’ SQUASH Scores in Participants Those Who Did Not Attain Remission or LDAS|This outcome analyses the quantitative SQUASH score and individual SQUASH scores by DAS28 categories. The quantitative SQUASH score (ranging from 0 to 17010.000) is calculated as the sum of subscores that capture physical activity related to commuting activities (SQUASH-A), leisure time activities (SQUASH-B), household activities (SQUASH-C) and activity at work and school (SQUASH-D). The SQUASH score and its subscores has non-negative values. Higher values indicate a higher individual activity level. DAS28 categories being assessed are remission (defined as DAS28 of less than 2.6) and LDAS (defined as DAS28 of less than 3.2).The DAS28 is a validated index of rheumatoid arthritis disease activity. Tender joint counts and swollen joint counts across 28 joints, C-reactive protein (CRP), and general health assessed via the visual analog scale (VAS) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.|Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF|Analysis included all participants who received at least one dose of adalimumab with evaluable data.||units on a scale||Standard Deviation|Mean
666479|NCT01756235|Secondary|Mean Change From Baseline in Total Physical Activity SQUASH Scores and Individual Physical Activity Categories’ SQUASH Scores in Participants in Remission or LDAS|This outcome analyses the quantitative SQUASH score and individual SQUASH scores by DAS28 categories. The quantitative SQUASH score (ranging from 0 to 17010.000) is calculated as the sum of subscores that capture physical activity related to commuting activities (SQUASH-A), leisure time activities (SQUASH-B), household activities (SQUASH-C) and activity at work and school (SQUASH-D). The SQUASH score and its subscores has non-negative values. Higher values indicate a higher individual activity level. DAS28 categories being assessed are remission (defined as DAS28 of less than 2.6) and LDAS (defined as DAS28 of less than 3.2).The DAS28 is a validated index of rheumatoid arthritis disease activity. Tender joint counts and swollen joint counts across 28 joints, C-reactive protein (CRP), and general health assessed via the visual analog scale (VAS) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.|Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF|Analysis included all participants who received at least one dose of adalimumab with evaluable data.||units on a scale||Standard Deviation|Mean
666480|NCT01756235|Secondary|Percentage of Participants With Low Disease Activity State (LDAS, DAS28<3.2)|LDAS is defined as DAS28 of less than 3.2. The DAS28 is a validated index of rheumatoid arthritis disease activity. Tender joint counts and swollen joint counts across 28 joints, C-reactive protein (CRP), and general health assessed via the visual analog scale (VAS) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.|Month 0, Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF|Analysis included all participants who received at least one dose of adalimumab with evaluable data.||percentage of participants|||Number
666481|NCT01756235|Secondary|Percentage of Participants in Clinical Disease Remission (DAS28<2.6)|Remission is defined as DAS28 of less than 2.6. The DAS28 is a validated index of rheumatoid arthritis disease activity. Tender joint counts and swollen joint counts across 28 joints, C-reactive protein (CRP), and general health assessed via the visual analog scale (VAS) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.|Month 0, Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF|Analysis included all participants who received at least one dose of adalimumab with evaluable data.||percentage of participants|||Number
666482|NCT01756235|Secondary|Mean Change From Baseline in Disease Activity Index - 28 Joints (DAS28) Score|The DAS28 is a validated index of rheumatoid arthritis disease activity. Tender joint counts and swollen joint counts across 28 joints, C-reactive protein, and general health assessed via the visual analog scale (VAS) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.|Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF|Analysis included all participants who received at least one dose of adalimumab with evaluable data.||units on a scale||Standard Deviation|Mean
666483|NCT01756235|Secondary|Mean Change From Baseline in SQUASH-D Scores|SQUASH subscores capture physical activity. SQUASH-D subscore captures activity at work and school, with scores ranging from 0 to 3402.000. The SQUASH subscores have non-negative values. Higher values indicate a higher individual activity level.|Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF|Analysis included all participants who received at least one dose of adalimumab with evaluable data.||units on a scale||Standard Deviation|Mean
666494|NCT01756079|Primary|Percentage of Participants With an Adverse Event Leading to Discontinuation of Study Medication|Adverse events were monitored during the Lead-in and Treatment Periods|Up to 48 weeks (Lead-in and Treatment Periods)|Safety Analysis Set 2 included all participants who received boceprevir during the Treatment Period||Percentage of participants|||Number
666485|NCT01756235|Secondary|Mean Change From Baseline in SQUASH-B Scores|SQUASH subscores capture physical activity. SQUASH-B subscore captures leisure time activities, with scores ranging from 0 to 6123.600. The SQUASH subscores have non-negative values. Higher values indicate a higher individual activity level.|Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF|Analysis included all participants who received at least one dose of adalimumab with evaluable data.||units on a scale||Standard Deviation|Mean
666486|NCT01756235|Secondary|Mean Change From Baseline in SQUASH-A Scores|SQUASH subscores capture physical activity. SQUASH-A subscore captures commuting activities, with scores ranging from 0 to 4082.400. The SQUASH subscores have non-negative values. Higher values indicate a higher individual activity level.|Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF|Analysis included all participants who received at least one dose of adalimumab with evaluable data.||units on a scale||Standard Deviation|Mean
666487|NCT01756235|Secondary|Mean Change From Baseline in Total Physical Activity SQUASH Score|The quantitative SQUASH score (scores range from 0 to 17010.000) is calculated as the sum of subscores that capture physical activity related to commuting activities (SQUASH-A), scores range from 0 to 4082.400, leisure time activities (SQUASH-B), scores range from 0 to 6123.600, household activities (SQUASH-C), scores range from 0 to 3402.000, and activity at work and school (SQUASH-D), scores range from 0 to 3402.000. The SQUASH score and its subscores has non-negative values. Higher values indicate a higher individual activity level.|Month 3, Month 6 and Month 9|Analysis included all participants who received at least one dose of adalimumab with evaluable data.||units on a scale||Standard Deviation|Mean
666488|NCT01756235|Primary|Mean Change From Baseline in Total Physical Activity Short Questionnaire to Assess Health-enhancing Physical Activity (SQUASH) Score|The quantitative SQUASH score (scores range from 0 to 17010.000) is calculated as the sum of subscores that capture physical activity related to commuting activities (SQUASH-A), scores range from 0 to 4082.400, leisure time activities (SQUASH-B), scores range from 0 to 6123.600, household activities (SQUASH-C), scores range from 0 to 3402.000, and activity at work and school (SQUASH-D), scores range from 0 to 3402.000. The SQUASH score and its subscores has non-negative values. Higher values indicate a higher individual activity level.|Month 0 (baseline) and Month 12 (Last Observation Carried Forward (LOCF))|Analysis included all participants who received at least one dose of adalimumab with evaluable data.||units on a scale||Standard Deviation|Mean
666489|NCT01756157|Secondary|Number of Angioedema Attacks Requiring Acute Treatment During the Treatment Period|Angioedema attack was defined as the participant-reported indication of symptoms or signs such as swelling or pain at any location following a report of no swelling or pain on the previous day. Manifestations of an attack that progress from one site to another, prior to complete resolution, was considered a single attack. Attacks that began to regress and then worsened before complete resolution was also considered one attack. Participants who were dosed but did not have any attacks in the period were assigned a value of zero. The number of attacks was normalized for the number of days participants participated in a given period and expressed as the monthly frequency.|From Visit 1 (Week 1) up to Visit 16 (Week 8) during each treatment period|ITT-E population||angioedema attacks||Standard Deviation|Mean
666490|NCT01756157|Secondary|Cumulative Symptomatic Days During the Treatment Period|Cumulative symptomatic days was defined as the sum of the symptomatic days of each angioedema attack reported during the treatment period. Participants who were dosed but did not have any attacks in the period were assigned a value of zero. Cumulative symptomatic days was normalized for the number of days participants participated in a given period and expressed as the monthly frequency.|From Visit 1 (Week 1) up to Visit 16 (Week 8) during each treatment period|ITT-E population||days||Standard Deviation|Mean
666491|NCT01756157|Secondary|Cumulative Daily-severity During the Treatment Period|"Cumulative Daily-severity score was the sum of the severity scores recorded for every day of reported symptoms during the treatment period.
Severity scores were recorded as None=0, Mild=1, Moderate=2, and Severe=3. None: no angioedema attack symptom; Mild: the angioedema attack symptom was noticeable to the participant but was easily tolerated and did not interfere with routine activities; Moderate: the angioedema attack symptom interfered with work/school or the ability to participate in family life and social activities; Severe: the angioedema attack symptom significantly limited the participant's ability to attend work/school or participate in family life and social activities.
Cumulative daily severity was normalized for the number of days participants participated in a given period and expressed as the monthly frequency.
The scores ranged from 0 to 168 and higher scores represent worse symptoms."|From Visit 1 (Week 1) up to Visit 16 (Week 8) during each treatment period|ITT-E population||Score on a scale||Standard Deviation|Mean
666492|NCT01756157|Secondary|Cumulative Attack-severity During the Treatment Period|"Cumulative Attack-severity score was the sum of maximum symptom severity recorded for each angioedema attack, determined on the last day of symptoms and recorded as None=0, Mild=1, Moderate=2, and Severe=3 and summing over the unique attacks, yields a Cumulative Attack-severity score.
None: no angioedema attack symptom; Mild: the angioedema attack symptom was noticeable to the participant but was easily tolerated and did not interfere with routine activities; Moderate: the angioedema attack symptom interfered with work/school or the ability to participate in family life and social activities; Severe: the angioedema attack symptom significantly limited the participant's ability to attend work/school or participate in family life and social activities.
Cumulative attack-severity was normalized for the number of days participants participated in a given period and expressed as the monthly frequency.
The scores ranged from 0 to 168 and higher scores represent worse symptoms."|From Visit 1 (Week 1) up to Visit 16 (Week 8) during each treatment period|ITT-E population||Score on a scale||Standard Deviation|Mean
666493|NCT01756157|Primary|Normalized Number of Angioedema Attacks During the Treatment Period|Angioedema attack was defined as the participant-reported indication of symptoms or signs such as swelling or pain at any location following a report of no swelling or pain on the previous day. Manifestations of an attack that progress from one site to another, prior to complete resolution, was considered a single attack. Attacks that began to regress and then worsened before complete resolution was also considered one attack. Participants who were dosed but did not have any attacks in the period were assigned a value of zero. The number of attacks was normalized for the number of days participants participated in a given period and expressed as the monthly frequency.|From Visit 1 (Week 1) up to Visit 16 (Week 8) during each treatment period|Intent-to-treat efficacy (ITT-E) population included all participants who completed both randomized treatment periods and fulfilled a priori defined evaluability criteria.||angioedema attacks||95% Confidence Interval|Mean
666495|NCT01756079|Primary|Percentage of Participants With One or More Adverse Events|Adverse events were monitored during the Lead-in and Treatment Periods|Up to 48 weeks (Lead-in and Treatment Periods)|Safety Analysis Set 2 included all participants who received boceprevir during the Treatment Period||Percentage of participants|||Number
666496|NCT01756079|Primary|Percentage of Participants Who Achieve Sustained Virological Response at Follow-up Week 24 (SVR24)|Hepatitis C Virus (HCV) ribonucleic acid (RNA) was measured using a polymerase chain reaction assay. SVR24 was defined as HCV RNA less than the Limit of Quantification (<25 International Units (IU)/mL) 24 weeks after the end of the Treatment Period.|Week 72 (24 weeks after end of treatment)|The Intent to Treat population included all participants who received at least 1 administration of boceprevir during the Treatment Period.||Percentage of participants||95% Confidence Interval|Number
666497|NCT01756053|Primary|Change in Abstinence-induced Cognitive Deficits (N-Back Correct Response Time)|"We will assess whether ABT-089 ameliorates the cognitive deficits due to smoking abstinence.
To assess, all subjects will complete a computerized N-Back task during the Testing Day Session (Days 6 & 37) in each study medication period. Each Testing Day session occurs after 24 hours of abstinence from smoking. During one study medication period, subjects will take active ABT-089; during the other period, subjects will take a matched placebo.
Each of the task conditions (0-, 1-, 2-, and 3-back) will be administered in a pseudorandomized counterbalanced order. Each difficulty level will consist of one block of 50 trials, preceded by a practice block of 20 trials. The primary dependent variables for this task are total number of correct responses (out of 60) and reaction time (milliseconds).
All computerized neurocognitive tasks are completed in a quiet, standardized environment in our clinic.
NOTE: Each PPT completes 1 Baseline (no tx.) and 2 Testing Days (ABT/Placebo)"|Baseline (Day 0) and Test Day (Days 6 & 37)|Only participants completing both study periods (n=13) were included in the analyses.||Milliseconds||Standard Deviation|Mean
666498|NCT01756053|Secondary|Effects of ABT-089 on Days of Biochemically-confirmed Abstinence|Daily smoking rate will be assessed at each in-person visit using the Timeline Follow-Back assessment. Abstinence will be confirmed by exhaled carbon monoxide levels during a ~4-day monitored abstinence phase within each period.|Days 7, 8, 9, 10, 38, 39, 40, & 41|Only participants completing both study periods (n=13) were included in the analyses.||Days of abstinence||Standard Deviation|Mean
666499|NCT01756053|Secondary|Effects of ABT-089 on Cigarette Ratings|Cigarette evaluation scale: The Cigarette Evaluation Scale (CES), developed to assess subjective effects of smoking, is an 11-item Likert-format measure. Questions include items for nausea and dizziness, craving relief, and enjoyment of airway sensations. Items are rated on a scale from 1 (“Not at all”) to 7 (“Extremely); a summary score is calculated as the mean of all responses (range: 1-7). Higher scores indicate stronger subjective effects of smoking.|Days 6 and 37|Only participants completing both study periods (n=13) were included in the analyses.||Scores on a scale||Standard Deviation|Mean
666500|NCT01756053|Secondary|Effects of ABT-089 on Attention-deficit and Hyperactive Symptoms|ADHD symptoms: The 27-item BAARS-IV scale was used to assess current attention-deficit and hyperactive symptoms. Participant rated the intensity of their symptoms using the following scale: 1= never or rarely, 2 = sometimes, 3 = often, or 4 = very often. A total score was calculated as the sum of the individual items (range: 27-108). Higher scores indicate more frequent ADHD symptoms.|Days 6 and 37|Only participants completing both study periods (n=13) were included in the analyses.||Scores on a scale||Standard Deviation|Mean
666501|NCT01756053|Secondary|Effects of ABT-089 on Smoking Urges/Craving|QSU-B: The 10-item brief QSU (QSU-B) questionnaire was used to assess smoking urges. Each item is rated on a 7-point scale (1 = strongly disagree, 7 = strongly agree). A total score is calculated as the sum of the individual items (range: 10-70). Higher scores indicate more severe urges to smoke.|Days 6 and 37|Only participants completing both study periods (n=13) were included in the analyses.||Scores on a scale||Standard Deviation|Mean
666502|NCT01756053|Secondary|Effects of ABT-089 on Withdrawal Symptoms|MNWS: The Minnesota Nicotine Withdrawal Scale - Revised version captures the current state of nicotine withdrawal. The scale assesses 15 items of nicotine withdrawal (including 7 DSM-IV items) such as: dysphoria or depressed mood, insomnia, irritability/frustration/anger, anxiety, difficulty concentrating, restlessness, and increased appetite/weight gain. Subjects will rate the intensity of their symptoms on the following scale: 0 = none, 1 = slight, 2 = mild, 3 = moderate, 4 = severe. A “withdrawal discomfort score” was calculated as the sum of the first 9 items (possible range: 0-36) and is a well-validated measure of nicotine withdrawal; a higher score indicates more severe withdrawal.|Days 6 and 37|Only participants completing both study periods (n=13) were included in the analyses.||Scores on a scale||Standard Deviation|Mean
666503|NCT01756053|Secondary|Effects of ABT-089 on Mood|PANAS: The Positive and Negative Affect Schedule (PANAS), a 20-item Likert-format self-report measure, was used to assess Positive Affect (PA; 10 items, e.g., enthusiastic, strong) and Negative Affect (NA; 10 items, e.g., distressed, upset), two dominant and generally orthogonal dimensions of affect. Scores for the 10 items on each subscale were summed to create summary scores (range: 10-50); higher scores indicate greater intensity of mood (i.e., more positive or more negative affect). Higher ratings of positive affect and lower ratings of negative affect are considered better outcomes.|Days 6 and 37|Only participants completing both study periods (n=13) were included in the analyses.||Scores on a scale||Standard Deviation|Mean
666504|NCT01756053|Primary|Change in Abstinence-induced Cognitive Deficits (N-Back Accuracy)|"We will assess whether ABT-089 ameliorates the cognitive deficits due to smoking abstinence.
To assess, all subjects will complete a computerized N-Back task during the Testing Day Session (Days 6 & 37) in each study medication period. Each Testing Day session occurs after 24 hours of abstinence from smoking. During one study medication period, subjects will take active ABT-089; during the other period, subjects will take a matched placebo.
Each of the task conditions (0-, 1-, 2-, and 3-back) will be administered in a pseudorandomized counterbalanced order. Each difficulty level will consist of one block of 50 trials, preceded by a practice block of 20 trials. The primary dependent variables for this task are total number of correct responses (out of 60) and reaction time (milliseconds).
All computerized neurocognitive tasks are completed in a quiet, standardized environment in our clinic.
NOTE: Each PPT completes 1 Baseline (no tx.) and 2 Testing Days (ABT/Placebo)"|Baseline (Day 0) and Test Day (Days 6 & 37)|Only participants completing both study periods (n=13) were included in the analyses.||Number of correct responses (out of 60)||Standard Deviation|Mean
666583|NCT01754714|Secondary|13 Carbon (Natural, Stable Isotope of Carbon) Methionine Breath Test|Time to peak|0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours*at Week 7*|||minutes||Inter-Quartile Range|Median
666505|NCT01755702|Secondary|Patients Global Assessment in Response to Treatment|Patients Global Assessment in Response to Treatment was assessed by a score in a scale from 0-4: 0- Poor; 1- Fair; 2- Good; 3- Very Good and 4- Excellent.|Baseline to 8 weeks|ITT population: All randomized participants who received at least one study medication and who had at least one post-baseline efficacy assessment.||Score on a scale|||Number
666506|NCT01755702|Secondary|Headache Severity|"Headache severity (scores) at 15, 30, 45, 60, 90, 120, and 240 minutes were calculated as change (difference) from baseline of pain intensity at each time point.
Pain intensity was measured by numerical rating scale which is a horizontal line with a scale from 0-10, where 0 represents no pain and 10 represents the worst possible pain."|Baseline to 4 hours|ITT population: All randomized participants who received at least one study medication and who had at least one post-baseline efficacy assessment.||Score on a scale||Standard Deviation|Mean
666507|NCT01755702|Secondary|Number of Participants With Complete Headache Relief|Number of headaches resolved at 1 and 2 hours before any rescue medication was calculated as number of participants with complete pain relief and headache severity of ‘no headache’ over total number of participants. These calculations were based on one headache per treatment per subject.|Baseline to 2 hours|ITT population: All randomized participants who received at least one study medication and who had at least one post-baseline efficacy assessment.||Participants|||Number
666508|NCT01755702|Secondary|Time to Rescue Medication|Time to rescue medication was evaluated.|Baseline to 6 hours post dose|ITT population: All randomized participants who received at least one study medication and who had at least one post-baseline efficacy assessment.||minutes||Full Range|Median
666509|NCT01755702|Secondary|Sum of TOTPAR and SPID (SPRID)|"Area under the time-response curve for change in headache intensity and headache relief (SPRID) at 60, 90, 120 and 240 minutes, was calculated as sum of TOTPAR and SPID:
SPRIDt = TOTPARt + SPIDt
TOTPAR was calculated as sum of the products of pain relief score. Participants were asked to choose a number on a scale of 0 to 4, where, 0- No pain relief; 1- A little or perceptible pain relief; 2- Meaningful pain relief; 3- A lot of relief; 4- Complete relief. The mean PRS scores were calculated on the basis of participant's response based on the above score.
SPID was calculated as the sum of headache intensity differences between baseline and at each time point. It was measured by numerical rating scale which is horizontal line with a scale from 0-10, where 0 represents no pain and 10 represents the worst possible pain."|Baseline to 4 hours|ITT population: All randomized participants who received at least one study medication and who had at least one post-baseline efficacy assessment.||Score on a scale||Standard Deviation|Mean
666510|NCT01755702|Secondary|Sum of Pain Intensity Difference (SPID)|"Sum of pain intensity difference (SPID) at 60, 90, 120 and 240 minutes – calculated as the sum of headache intensity differences between the baseline pain intensity score and pain intensity score at each timepoint.
Pain intensity was measured by numerical rating scale which is horizontal line with a scale from 0-10, where 0 represents no pain and 10 represents the worst possible pain.
It was calculated using the following formula; SPID t = ΣPID x (time t - time t-1), where PID = PI (baseline) - PI t and PI = pain intensity."|Baseline to 4 hours|ITT population: All randomized participants who received at least one study medication and who had at least one post-baseline efficacy assessment.||Score on a scale||Standard Deviation|Mean
666511|NCT01755702|Secondary|Total Pain Relief (TOTPAR)|"TOTPAR was calculated as sum of the products of pain relief score at time interval at 0-60 minutes, 60-90 minutes, 90-120 minutes and 120-240 minutes. Participants were asked to choose a number on a scale of 0 to 4, where, 0- No pain relief; 1- A little or perceptible pain relief; 2- Meaningful pain relief; 3- A lot of relief; 4- Complete relief. The mean PRS scores were calculated on the basis of participant's response based on the above score.
It was calculated using the following formula.
TOTPAR t = Σ(Rt x (time t - time t-1)), where Rt = pain relief score at time t; time t = time t in hours; time t-1 = time at previous time-point."|Baseline to 4 hours|ITT population: All randomized participants who received at least one study medication and who had at least one post-baseline efficacy assessment.||Score on a scale||Standard Deviation|Mean
666512|NCT01755702|Secondary|Headache Relief Scores|Pain relief scores were measured on a scale from 0-4: 0- No pain relief; 1- Perceptible pain relief; 2- Meaningful pain relief; 3- A lot of relief and 4- Complete relief.|Baseline to 4 hours|ITT population: All randomized participants who received at least one study medication and who had at least one post-baseline efficacy assessment.||Score on a scale||Standard Deviation|Mean
666513|NCT01755702|Primary|Time to First Perceptible Headache Relief|Time to first perceptible pain relief, calculated as time when partcipant selected ‘a little’ pain relief in the electronic pad minus the time of treatment. If this time was not available in the electronic pad then the earliest time corresponding to a pain relief score 1 or greater was recorded as time to ‘a little’ pain relief.|Baseline to 6 hours|Intention to treat (ITT) population: All randomized participants who received at least one study medication and who had at least one post-baseline efficacy assessment.||minutes||Full Range|Median
666514|NCT01755637|Secondary|Cmax of Active Metabolite - Albendazole Sulphoxide|Cmax was depicted from plasma concentration of Albendazole.|Blood samples were collected pre-dose at 0 hr and post dose at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 7, 9, 12, 16, 24 and 36 hr|The analysis was carried out per protocol population. Missing data was not imputed for evaluation.||ng/mL||Standard Deviation|Mean
666515|NCT01755637|Secondary|AUC (0-inf) of Active Metabolite - Albendazole Sulphoxide|AUC (0-inf) of Albendazole sulphoxide was evaluated using the trapezoid rule.|Blood samples were collected pre-dose at 0 hr and post dose at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 7, 9, 12, 16, 24 and 36 hr|The analysis was carried out per protocol population. Participants were excluded where the baseline concentration was greater than 5% of Cmax.||ng.hr/mL||Standard Deviation|Mean
666516|NCT01755637|Secondary|AUC (0-t) of Active Metabolite - Albendazole Sulphoxide|AUC (0-t) of Albendazole i.e. Albendazole sulphoxide was evaluated using the trapezoid rule.|Blood samples were collected pre-dose at 0 hr and post dose at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 7, 9, 12, 16, 24 and 36 hr|The analysis was carried out per protocol population. Participants were excluded where the baseline concentration was greater than 5% of Cmax.||ng.hr/mL||Standard Deviation|Mean
666517|NCT01755637|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Albendazole|Tmax was time at which Cmax of Albendazole was reached.|Blood samples were collected pre-dose at 0 hr and post dose at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 7, 9, 12, 16, 24 and 36 hr|The analysis was carried out per protocol population. Participants were excluded where the baseline concentration was greater than 5% of Cmax.||hr||Full Range|Median
666518|NCT01755637|Primary|Maximum Observed Plasma Concentration [Cmaximum (Max)] of Albendazole|Cmax was depicted from plasma concentration of Albendazole.|Blood samples were collected pre-dose at 0 hr and post dose at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 7, 9, 12, 16, 24 and 36 hr|The analysis was carried out per protocol population. Missing data was not imputed for evaluation.||ng/mL||Standard Deviation|Mean
666519|NCT01755637|Primary|AUC [0-infinity (Inf)] of Albendazole|AUC (0-inf) was evaluated using the trapezoid rule.|Blood samples were collected pre-dose at 0 hr and post dose at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 7, 9, 12, 16, 24 and 36 hr|The analysis was carried out per protocol population. Missing data was not imputed for evaluation.||ng.hr/mL||Standard Deviation|Mean
666520|NCT01755637|Primary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to Time t [AUC(0-t)] of Albendazole.|AUC (0-t) was evaluated using the trapezoid rule.|Blood samples were collected pre-dose 0 hour (hr) and post dose 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 7, 9, 12, 16, 24 and 36 hr|The analysis was carried out per protocol population. Missing data was not imputed for evaluation.||nanogram (ng).hr per milliliter (mL)||Standard Deviation|Mean
666521|NCT01755455|Secondary|Change From Baseline in Sputum Iron (ng/mg)||Baseline and 6 weeks|||ng/mg||Standard Error|Mean
666522|NCT01755455|Secondary|Change From Baseline in Transferrin Saturation (%)||Baseline and 6 weeks|||% saturation||Standard Error|Mean
666523|NCT01755455|Secondary|Change From Baseline in Serum Iron (mcg/dl)||Baseline and 6 weeks|||mcg/dl||Standard Error|Mean
666524|NCT01755455|Primary|Change From Baseline in Hemoglobin Concentration (gm/dl)||Baseline and 6 weeks|||gm/dl||Standard Error|Mean
666525|NCT01755234|Secondary|Opioid Use Discharge From Post Anesthesia Care Unit to 24 Hours After PACU Discharge.|Opioid use in mg of morphine equivalents from discharge from the post anesthesia care unit to 24 hours after PACU discharge.|Discharge from PACU to 24 hours post operative after PACU discharge.|||mg morphine equivalents||Inter-Quartile Range|Median
666526|NCT01755234|Secondary|Pain in Post Anesthesia Care Unit|"Numeric rating scale for pain on a scale of 0-10 (0 is no pain and 10 is high pain) versus time curve in the post anesthesia care unit ( score * min). A higher value indicates more pain and time in the Post Anesthesia Care Unit.
The range is 0 pain to x time in minutes x 1 hour to 5 hour ( 60-300 minutes) . The pain scores were collected at 15 minute intervals from the time of admission to the PACU. The area under the NRS pain scale versus time curve was calculated using the trapezoidal method as an indicator of pain burden during early recovery (Graph Pad Prism ver 5.03, Graph Pad Software INC."|Time in the post anesthesia care unit|||Pain Score * minutes in PACU||Inter-Quartile Range|Median
666527|NCT01755234|Secondary|Mg of Morphine Equivalents (IV)|Total opioid use in the post operative care unit (Mg of morphine equivalents)|PACU admission to discharge|||miligrams of morphine equivalents||Inter-Quartile Range|Median
666528|NCT01755234|Primary|Quality of Recovery Score 24 Hours Post Operative|Quality of recovery score 24 hours after the surgical procedure.Score of 40 is poor recovery and a score of 200 is good recovery.|24 hours after the surgical procedure|||units on a scale||Inter-Quartile Range|Median
666529|NCT01755169|Primary|Number of Participants With Dose Limiting Toxicity|A total of 7 patients enrolled on the trial. However, 2 participants withdrew from the trial before they were randomized and 1 participant withdrew from the trial before being treated. Hence, the total number of patients for assessment is 4.|2 weeks|||Participants|||Count of Participants
666530|NCT01755156|Secondary|Percentage of Participants Requiring Glycemic Rescue Therapy at or Before Week 104 (Phase A+B)|Data presented are a cumulative incidence of participants with glycemic rescue by Week 104.|Up to 104 weeks|All participants randomized population.||Percentage of participants|||Number
666531|NCT01755156|Secondary|Percentage of Participants Requiring Glycemic Rescue Therapy at or Before Week 24 (Phase A)|Data presented are a cumulative incidence of participants with glycemic rescue by Week 24.|Up to 24 weeks|All participants randomized population.||Percentage of participants|||Number
666532|NCT01755156|Secondary|Kaplan-Meier Estimate of Cumulative Incidence of Participants Requiring Glycemic Rescue Therapy by 104 Weeks (Phase A+B)|Participants who did not meet progressively stricter glycemic criteria in Phase A had rescue initiated with open-label glimepiride. If during Phase B participants on open-label glimepiride or blinded glimepiride/glimepiride matching placebo needed rescue after maximum up-titration, then insulin glargine was initiated and the dose of open-label glimepiride or blinded glimepiride/glimepiride-matching placebo was discontinued.|Up to 104 weeks|All participants randomized population.||Percentage of participants||95% Confidence Interval|Number
666533|NCT01755156|Secondary|Kaplan-Meier Estimate of Cumulative Incidence of Participants Requiring Glycemic Rescue Therapy by 24 Weeks (Phase A)|Participants who did not meet progressively stricter glycemic criteria in Phase A had rescue initiated with open-label glimepiride.|Up to 24 weeks|All participants randomized population.||Percentage of participants||95% Confidence Interval|Number
666534|NCT01755156|Secondary|Change From Baseline in Fasting Insulin at Week 104 (Phase A+B)|Change from baseline in fasting insulin at Week 104 based on a cLDA model including terms for treatment, time, and the interaction of time by treatment.|Baseline and Week 104|Full analysis set population included all randomized participants who received at least one dose of study medication and had a baseline measurement or a post-randomization measurement.||μIU/mL||95% Confidence Interval|Least Squares Mean
666535|NCT01755156|Secondary|Change From Baseline in Fasting Insulin at Week 24 (Phase A)|Change from baseline in fasting insulin at Week 24 based on a cLDA model including terms for treatment, time, and the interaction of time by treatment.|Baseline and Week 24|Full analysis set population included all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a post-randomization measurement.||micro International Unit (μIU)/mL||95% Confidence Interval|Least Squares Mean
666536|NCT01755156|Secondary|Change From Baseline in PMG Total Area Under the Plasma Concentration Time Curve (AUC) at Week 24 (Phase A)|Change from baseline in PMG total AUC at Week 24 based on a cLDA model including terms for treatment, time, and the interaction of time by treatment. Plasma glucose levels were measured before the meal (0 minutes), and at 60 and 120 minutes after the meal.|Baseline and Week 24|Full analysis set population included all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a post-randomization measurement.||mg*h/dL||95% Confidence Interval|Least Squares Mean
666584|NCT01754714|Secondary|13 Carbon (Natural, Stable Isotope of Carbon) Methionine Breath Test|Peak|0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours*at Week 7*|||Atom %C13||Standard Deviation|Mean
666537|NCT01755156|Secondary|Percentage of Participants Attaining A1C Glycemic Goals of <6.5% After 104 Weeks of Treatment (Phase A+B)|Percentage of participants attaining A1C glycemic goals of <6.5% (48 mmol/mol) after 104 weeks of treatment estimated using standard multiple imputation techniques.|104 weeks|Full analysis set population included all randomized participants who received at least one dose of study medication and had a baseline measurement or a post-randomization measurement.||Percentage of participants||95% Confidence Interval|Least Squares Mean
666538|NCT01755156|Secondary|Percentage of Participants Attaining A1C Glycemic Goals of <7% After 104 Weeks of Treatment (Phase A+B)|Percentage of participants attaining A1C glycemic goals of <7.0% (53 mmol/mol) after 104 weeks of treatment estimated using standard multiple imputation techniques.|104 weeks|Full analysis set population included all randomized participants who received at least one dose of study medication and had a baseline measurement or a post-randomization measurement.||Percentage of participants||95% Confidence Interval|Least Squares Mean
666539|NCT01755156|Secondary|Percentage of Participants Attaining A1C Glycemic Goals of <6.5% After 24 Weeks of Treatment (Phase A)|Percentage of participants attaining A1C glycemic goals of <6.5% (48 mmol/mol) after 24 weeks of treatment estimated using standard multiple imputation techniques.|24 weeks|Full analysis set population included all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a post-randomization measurement.||Percentage of participants||95% Confidence Interval|Number
666540|NCT01755156|Secondary|Percentage of Participants Attaining A1C Glycemic Goals of <7.0% After 24 Weeks of Treatment (Phase A)|Percentage of participants attaining A1C glycemic goals of <7.0% (53 mmol/mol) after 24 weeks of treatment estimated using standard multiple imputation techniques.|24 weeks|Full analysis set population included all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a post-randomization measurement.||Percentage of participants||95% Confidence Interval|Number
666541|NCT01755156|Secondary|Change From Baseline in FPG at Week 104 (Phase A+B)|Change from baseline in FPG at Week 104 was analyzed using cLDA method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, time, and the interaction of time by treatment.|Baseline and Week 104|Full analysis set population included all randomized participants who received at least one dose of study medication and had a baseline measurement or a post-randomization measurement.||mg/dL||95% Confidence Interval|Least Squares Mean
666542|NCT01755156|Secondary|Change From Baseline in A1C at Week 104 (Phase A+B)|A1C is measured as a percent. Change from baseline in A1C at Week 104 was analyzed using cLDA method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, time, and the interaction of time by treatment.|Baseline and Week 104|Full analysis set population included all randomized participants who received at least one dose of study medication and had a baseline measurement or a post-randomization measurement.||Percent||95% Confidence Interval|Least Squares Mean
666543|NCT01755156|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Phase A)|Change from baseline in FPG at Week 24 was analyzed using cLDA method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, time, and the interaction of time by treatment.|Baseline and Week 24|Full analysis set population included all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a post-randomization measurement.||mg/dL||95% Confidence Interval|Least Squares Mean
666544|NCT01755156|Secondary|Change From Baseline in 2-hour Post-meal Glucose (PMG) at Week 24 (Phase A)|Change from baseline in 2-hour PMG at Week 24 was analyzed using cLDA method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, time, and the interaction of time by treatment.|Baseline and Week 24|Full analysis set population included all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a post-randomization measurement.||mg/dL||95% Confidence Interval|Least Squares Mean
666545|NCT01755156|Primary|Percentage of Participants Who Experienced an Adverse Event Which Were Included Under the System Order Class of Investigations (Phase A+B)|The following laboratory parameters were included: blood chemistry, hematology, electrocardiograms, lipids, body weight, and vital signs.|Up to 104 weeks|All participants as treated population included all participants who received at least one dose of study medication.||Percentage of participants|||Number
666546|NCT01755156|Primary|Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (Phase A+B)|An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Presented data exclude data after glycemic rescue.|Up to 104 weeks|All participants as treated population included all participants who received at least one dose of study medication.||Percentage of participants|||Number
666547|NCT01755156|Primary|Percentage of Participants Who Experienced at Least One Adverse Event (Phase A+B)|An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Presented data exclude data after glycemic rescue.|Up to 107 weeks|All participants as treated population included all participants who received at least one dose of study medication.||Percentage of participants|||Number
666548|NCT01755156|Primary|Change From Baseline in Glycosylated Hemoglobin (A1C) at Week 24 (Phase A)|A1C is measured as a percent. Change from baseline in A1C at Week 24 was analyzed using a constrained longitudinal data analysis (cLDA) method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, time, and the interaction of time by treatment.|Baseline and Week 24|Full analysis set population included all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a post-randomization measurement.||Percent||95% Confidence Interval|Least Squares Mean
666549|NCT01755143|Secondary|Proportion of Subjects Who Experience a Decrease Less Than or Equal to 50% in Ventricular Sensing Amplitude|Subjects' ventricular sensed amplitude was measured at the 9-12 week visit (pre-MRI/waiting period) and the 4-month visit (i.e. one month post-MRI/waiting period). A success was defined as a 50% or less decrease in ventricular sensed amplitude between the two visits.|Pre-MRI/waiting period (9-12 weeks post implant) to one month post-MRI/waiting period|||participants|||Number
666585|NCT01754714|Secondary|Methionine Volume of Distribution at Week 7 (L)|After the methionine load, blood samples will be obtained at 0.5, 1, 1.5, 3, 4, 5, 6, 7.5 and 9 hours. Plasma will be analyzed for methionine.|0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours*at Week 7*|||L||Standard Deviation|Mean
666550|NCT01755143|Secondary|Occurrence of Sustained Ventricular Arrhythmias and Asystole During MRI Scans.|The endpoint was the occurrence of sustained ventricular arrhythmias and asystole during MRI scans and attributable to the MR scan. Sustained ventricular arrhythmias or asystole episodes that occurred during the MRI scan was considered attributable to the MR scan if so adjudicated by the Adverse Events Adjudication Committee|During MRI scans (9-12 weeks post-implant)|||participants|||Number
666551|NCT01755143|Secondary|Proportion of Subjects Who Experience a Decrease Less Than or Equal to 50% in Atrial Sensing Amplitude|Subjects' atrial sensed amplitude was measured at the 9-12 week visit (pre-MRI/waiting period) and the 4-month visit (i.e. one month post-MRI/waiting period). A success was defined as a 50% or less decrease in atrial sensed amplitude between the two visits.|Pre-MRI /waiting period (9-12 weeks post-implant) to 1-month post-MRI/waiting period|Only subjects with measured sensed amplitude values at both pre-MRI/waiting period and the 4-month visit were used in the analysis.||participants|||Number
666552|NCT01755143|Primary|Proportion of Subjects Who Experience an Increase Less Than or Equal to 0.5V in Ventricular Voltage Thresholds|Subjects' ventricular pacing capture threshold was measured at the 9-12 week visit (pre-MRI/waiting period) and the 4-month visit (i.e. one month post-MRI/waiting period). A success was when a subject experienced an increase less than or equal to 0.5V (volts) between the two visits.|Pre-MRI/waiting period (9-12 weeks post implant) to one month post-MRI/waiting period|||participants|||Number
666553|NCT01755143|Primary|Proportion of Subjects Who Experience an Increase Less Than or Equal to 0.5V in Atrial Voltage Thresholds|Subjects' atrial pacing capture threshold was measured at the 9-12 week visit (pre-MRI/waiting period) and the 4-month visit (i.e. one month post-MRI/waiting period). A success was when a subject experienced an increase less than or equal to 0.5V (volts) between the two visits.|Pre-MRI/waiting period (9-12 weeks post implant) to one month post-MRI/waiting period|To be included in the analysis, subjects in the MRI group must undergo an MRI scan and those in the Control group must complete the 9-12 week visit, and all the subjects must have valid pacing capture threshold measurements at pre-MRI/waiting period and the 4-month visit.||participants|||Number
666554|NCT01755143|Primary|MRI-related Complication Free Rate|Number of patients free of MRI-related complications|MRI scan to one month later|Patients who underwent an MRI||participants|||Number
666555|NCT01755026|Primary|Cefazolin Levels|Cefazolin levels|2 hours|||mcg/mL||Standard Error|Mean
666556|NCT01754922|Primary|Heart Rate Variability|Ratio of low-frequency to high-frequency power for heart rate variability|Resting baseline; cross-sectional|Signal quality of the the electrocardiogram was poor for 3 individuals; therefore, their data were removed from final analysis.||Ratio||Standard Deviation|Mean
666557|NCT01754922|Primary|VO2 Peak|Maximal oxygen consumption measured during exercise|At peak exercise; cross-sectional|4 participants were excluded due to failure to meet maximal exercise criteria (3 from exposed, 1 from control). Therefore, we removed these individuals from the final analysis.||ml/min/kg||Standard Deviation|Mean
666558|NCT01754922|Primary|FEV1|Forced expiratory volume in 1 second (FEV1) measured before and after an exercise challenge|Pre/post exercise; cross-sectional|||percentage of predicted normal values||Standard Deviation|Mean
666559|NCT01754766|Secondary|Conjunctival Hyperemia Score|Conjunctival hyperemia is the engorgement of the blood vessels (redness) of the clear membrane covering the white surface of the eye. Conjunctival hyperemia was evaluated 15 minutes post conjunctival allergen challenge (CAC) (8 hours post dose) on Day 1 for both eyes using a 9-point scale in half-unit increments where: 0=none to 4=Extremely severe. The score for each participant was the average of the score of both eyes.|Day 1|Modified Intent-to-treat (MITT) population included all randomized participants with ocular itching score data available for this time point||Score on a scale||Standard Deviation|Mean
666560|NCT01754766|Secondary|Ocular Itching Score at Day 15|The participant evaluated ocular itching in both eyes 5 minutes post conjunctival allergen challenge (16 hours post-dose) at Day 15 using a 9-point scale in half-unit increments where: 0=none to 4=incapacitating itch with an irresistible urge to rub. The score for each participant was the average of the score of both eyes.|Day 15|Modified Intent-to-treat (MITT) population included all randomized participants with ocular itching score data available for this time point||Score on a scale||Standard Deviation|Mean
666561|NCT01754766|Primary|Ocular Itching Score at Day 1|The participant evaluated ocular itching in both eyes 5 minutes post conjunctival allergen challenge (CAC) (8 hours post-dose) at Day 1 using a 9-point scale in half-unit increments where: 0=none to 4=incapacitating itch with an irresistible urge to rub. The score for each participant was the average of the score of both eyes.|Day 1|Modified Intent-to-treat (MITT) population included all randomized participants with ocular itching score data available for this time point||Score on a scale||Standard Deviation|Mean
666562|NCT01754727|Secondary|Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score|The BASFI is a numeric rating scale that uses self-reported patient evaluations to measure physical function impairment caused by AS. It is a ten questions, each question was scored on a numerical rating scale that ranged from 0 (no functional impairment) to 10 (maximal impairment). The mean of the ten questions was the total BASFI score. A higher score indicates more severe impairment of functioning.|Month 3, Month 6, Month 9 and Month 12|Analysis included all participants who received at least one dose of adalimumab with evaluable data.||units on a scale||Standard Deviation|Mean
666563|NCT01754727|Secondary|Mean Change From Baseline in Ankylosing Spondylitis Disease Activity (ASDAS) Score|The ASDAS tool is a self-administered questionnaire plus an objective laboratory evaluation. The questionnaire covers disease activity, back pain, and peripheral pain/swelling assessed on a visual analogue scale (from 0 (normal) to 10 (extreme pain or disability) cm) and duration of morning stiffness on a numerical rating scale (from 0 to 10, with 0 being none and 10 representing a duration of 2 hours or longer). The laboratory parameter is a measurement of C-reactive protein (mg/L) (CRP) or erythrocyte sedimentation rate (mm/h) (ESR). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and either CRP or ESR values) are combined to yield a score ranging from 0 to no defined upper limit. Higher scores indicate higher disease activity. Remission is defined as ASDAS score <1.3. Clinically important improvement is defined as a change >= 1.1 units, and major improvement is defined as a change >= 2.0 units.|Month 3, Month 6, Month 9 and Month 12|Analysis included all participants who received at least one dose of adalimumab with evaluable data.||units on a scale||Standard Deviation|Mean
668250|NCT01729026|Secondary|Community Integration Questionnaire (CIQ)|Self-rating scale that assesses the extent of a subject's integration into her or his community|Baseline and 3-month and 6-month follow-up visits||||||
666564|NCT01754727|Secondary|Mean Change From Baseline in BASDAI Score|The BASDAI score was determined using a simple, self-reported questionnaire that consists of 6 questions on disease activity. Each question is scored from 0 to 10 (0 = no symptoms, 10 = very severe symptoms).|Month 3, Month 6, Month 9, Month 12 and Month 12 Last Observation Carried Forward (LOCF)|Analysis included all participants who received at least one dose of adalimumab with evaluable data.||units on a scale||Standard Deviation|Mean
666565|NCT01754727|Secondary|Mean Change in the Number of Outpatient Visits to Each Kind of Health Care Provider|Difference in the number of outpatient visits to each kind of health care provider which includes general practitioner, rheumatologist, other specialists (ophthalmologist, gastroenterologist, dermatologist, physiatrist), physiotherapist and rheumatology nurse, during 12 months of adalimumab therapy and 12 months preceding the introduction of adalimumab therapy.|12 months prior to month 0 (baseline) and 12 months prior to month 12|Analysis included all participants who received at least one dose of adalimumab with evaluable data.||Number of visits||Standard Deviation|Mean
666566|NCT01754727|Secondary|Mean Change in the Number of Sick Leaves|Difference in the number of sick leaves during 12 months of adalimumab therapy and 12 months preceding the introduction of adalimumab therapy (in employed subjects only).|12 months prior to month 0 (baseline) and 12 months prior to month 12|Analysis included all participants who received at least one dose of adalimumab with evaluable data.||Number of sick leaves||Standard Deviation|Mean
666567|NCT01754727|Secondary|Mean Change in the Number of Sick Leave Days|Difference in the number of sick leave days during 12 months of adalimumab therapy and 12 months preceding the introduction of adalimumab therapy (in employed subjects only)|12 months prior to month 0 (baseline) and 12 months prior to month 12|Analysis included all participants who received at least one dose of adalimumab with evaluable data.||Days||Standard Deviation|Mean
666568|NCT01754727|Secondary|Mean Change in the Number of Hospitalizations|Difference in the number of hospitalizations during 12 months of adalimumab therapy and 12 months preceding the introduction of adalimumab therapy.|12 months prior to month 0 (baseline) and 12 months prior to month 12|Analysis included all participants who received at least one dose of adalimumab with evaluable data.||Number of admissions to hospital||Standard Deviation|Mean
666569|NCT01754727|Secondary|Mean Change in the Number of Hospital Inpatient Days|Difference in the number of hospital inpatient days during 12 months of adalimumab therapy and 12 months preceding the introduction of adalimumab therapy.|12 months prior to month 0 (baseline) and 12 months prior to month 12|Analysis included all participants who received at least one dose of adalimumab with evaluable data.||Days||Standard Deviation|Mean
666570|NCT01754727|Secondary|Percentage of Participants Achieving At Least 2.0 Score Decrease in Ankylosing Spondylitis Disease Activity (ASDAS) Score From Baseline|The ASDAS tool is a self-administered questionnaire plus an objective laboratory evaluation. The questionnaire covers disease activity, back pain, and peripheral pain/swelling assessed on a visual analogue scale (from 0 (normal) to 10 (extreme pain or disability) cm) and duration of morning stiffness on a numerical rating scale (from 0 to 10, with 0 being none and 10 representing a duration of 2 hours or longer). The laboratory parameter is a measurement of C-reactive protein (mg/L) (CRP) or erythrocyte sedimentation rate (mm/h) (ESR). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and either CRP or ESR values) are combined to yield a score ranging from 0 to no defined upper limit. Higher scores indicate higher disease activity. Clinically important improvement is defined as a change >= 1.1 units, and major improvement is defined as a change >= 2.0 units.|Month 3, Month 6, Month 9 and Month 12|Analysis included all participants who received at least one dose of adalimumab with evaluable data.||percentage of participants|||Number
666571|NCT01754727|Secondary|Percentage of Participants Achieving BASDAI 50|The BASDAI score was determined using a simple, self-reported questionnaire that consists of 6 questions on disease activity. Each question is scored from 0 to 10 (0 = no symptoms, 10 = very severe symptoms). The BASDAI 50 score captures patients with 50% reduction in the BASDAI score compared to baseline.|Month 3, Month 6 and Month 9|Analysis included all participants who received at least one dose of adalimumab with evaluable data.||percentage of participants|||Number
666572|NCT01754727|Primary|Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 at Month 12|The BASDAI score was determined using a simple, self-reported questionnaire that consists of 6 questions on disease activity. Each question is scored from 0 to 10 (0 = no symptoms, 10 = very severe symptoms). The BASDAI 50 score captures patients with 50% reduction in the BASDAI score compared to baseline as observed.|Month 0 (baseline) and Month 12|Analysis included all participants who received at least one dose of adalimumab with evaluable data.||percentage of participants|||Number
666573|NCT01754714|Secondary|Hepatic Panel (Liver Laboratory Parameters)|ALT/AST ratio|change from baseline at 6 weeks|||Ratio||Standard Deviation|Mean
666574|NCT01754714|Secondary|Area Under Curve (AUC) of Average Methionine Concentration Versus Time Curve|After the methionine load, blood samples will be obtained at 0.5, 1, 1.5, 3, 4, 5, 6, 7.5 and 9 hours. Plasma will be analyzed for methionine.|0.5, 1, 1.5, 3, 4, 5, 6, 7.5 and 9 hours *at Week 7*|||mcg/mL||Standard Deviation|Mean
666575|NCT01754714|Secondary|Fibrosis and Apoptosis Markers (Fibrosis and Apoptosis Laboratory Markers)|Hyaluronic acid|change from baseline at 6 weeks|||ng/mL||Standard Deviation|Mean
666576|NCT01754714|Secondary|Fibrosis and Apoptosis Markers (Fibrosis and Apoptosis Laboratory Markers)|Caspase-cleaved cytokeratin (CK 18)|change from baseline at 6 weeks|||U/L||Standard Deviation|Mean
666577|NCT01754714|Secondary|Immunological/Anti-oxidant Panel (Immunological and Anti-oxidant Laboratory Parameters)|oxidative stress marker (isoprostane level)|change from baseline at 6 weeks|||ng/mg Crea||Standard Deviation|Mean
666578|NCT01754714|Secondary|Immunological/Anti-oxidant Panel (Immunological and Anti-oxidant Laboratory Parameters)|glutathione in erythrocytes|change from baseline at 6 weeks|||mcmol/g||Standard Deviation|Mean
666579|NCT01754714|Secondary|Immunological/Anti-oxidant Panel (Immunological and Anti-oxidant Laboratory Parameters)|C-reactive Protein (CRP)|change from baseline at 6 weeks|||nmol/L||Standard Deviation|Mean
666580|NCT01754714|Secondary|Metabolic Panel (Metabolic Laboratory Parameters)|Adiponectin|change from baseline at 6 weeks|||mcg/mL||Standard Deviation|Mean
666581|NCT01754714|Secondary|Metabolic Panel (Metabolic Laboratory Parameters)|glycosylated hemoglobin (HbA1c)|change from baseline at 6 weeks|||Percentage||Standard Deviation|Mean
666582|NCT01754714|Secondary|Metabolic Panel (Metabolic Laboratory Parameters)|Fasting plasma insulin|Change from baseline at 6 weeks|||pmol/L||Standard Deviation|Mean
666586|NCT01754714|Secondary|The Metabolic Clearance Rate Measured in the Blood.|After the methionine load, blood samples will be obtained at 0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours. Plasma will be analyzed for methionine.|0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours*at Week 7*|||L/h||Standard Deviation|Mean
666587|NCT01754714|Other Pre-specified|Fibrosis and Apoptosis Markers (Fibrosis and Apoptosis Laboratory Markers)|"Non-invasive test for liver disease (ActiTest)/Fibrotest
FibroTest® : diagnoses hepatic fibrosis ActiTest® : assesses viral necro-inflammatory activity Scores between 0 and 1, the higher the score the worse
The FibroTest score is calculated from the results of a six-parameter blood test, combining six serum markers with the age and gender of the patient:Alpha-2-macroglobulin, Haptoglobin, Apolipoprotein A1, Gamma-glutamyl transpeptidase (GGT), Total bilirubin, and Alanine transaminase (ALT). ALT is used in a second assessment called ActiTest that is part of FibroTest."|change from baseline at 6 weeks|||scores on a scale||Standard Deviation|Mean
666588|NCT01754714|Other Pre-specified|Immunological/Anti-oxidant Panel (Immunological and Anti-oxidant Laboratory Parameters)|Cytokine profile ( Interleukin-6, IL-8, IL-10 (IL), Tumor Necrosis Factor (TNF -α), monocyte chemoattractant protein (MCP-1), and Granulocyte-colony stimulating factor (G-CSF ).|change from baseline at 6 weeks|||pg/mL||Standard Deviation|Mean
666589|NCT01754714|Secondary|Metabolic Panel (Metabolic Laboratory Parameters)|Fasting lipid profile (cholesterol, HDL (High Density Lipoprotein), LDL (Low Density Lipoprotein)), amino acid profile, homeostasis model assessment (HOMA-R) and fasting glucose.|change from baseline at 6 weeks|||mmol/L||Standard Deviation|Mean
666590|NCT01754714|Secondary|Hepatic Panel (Liver Laboratory Parameters)|Serum Total Bilirubin (STB), Serum Conjugated Bilirubin (SCB), liver-alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), Gamma Glutamyl Transpeptidase (GGT)|change from baseline at 6 weeks|||U/L||Standard Deviation|Mean
666591|NCT01754714|Secondary|13 Carbon (Natural, Stable Isotope of Carbon) Methionine Breath Test|parameters cumulative percentage dose of 13 carbon recovered after 30, 60, 90 minutes (cPDR30, cPDR60, cPDR 90) will be evaluated|0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours*at Week 7*|||percentage of recovery||Standard Deviation|Mean
666592|NCT01754714|Secondary|Fasting Methionine Concentration of Average Methionine Concentration Versus Time Curve.|After the methionine load, blood samples will be obtained at 0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours. Plasma will be analyzed for methionine.|0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours*at Week 7*|||mcg/mL||Standard Deviation|Mean
666593|NCT01754714|Primary|Methionine Elimination Half-life Measured in Blood.|After the methionine load, blood samples will be obtained at 0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours. Plasma will be analyzed for methionine.|0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours*at Week 7*|||hour||Standard Deviation|Mean
666594|NCT01754623|Secondary|Overall Survival (OS) Rate|OS at time of analysis, calculated from date of enrollment to date of death from any cause.|12 months|All participants per group||percentage of participants|||Number
666595|NCT01754623|Secondary|Progression-Free Survival (PFS) at Three Years|PFS is defined as the duration of time from enrollment to time of death or progression of disease, whichever occurs first. Progressive Disease (PD): At least a 20% increase in the longest diameter (LD) of the target lesion or appearance of new lesions at metastatic sites.|3 years|Evaluable participants at 3 years.|||||
666596|NCT01754623|Primary|Margin-negative (R0) Resection Rate|R0 rate for all participants with resection. Margin negative surgery (R0 resection) is an absolute part of the curative treatment of pancreatic cancer.The primary endpoint is correlation of a radio sensitivity index score derived from the microarray analysis and pathologic response on surgical specimens. Tumor regression Rating: R0 (Complete Response). R0 resections are scored as those resections in which the common bile duct margin, pancreatic resection margin, retroperitoneal margin are negative for tumor involvement.|Up to 3 years|All participants with resection||percentage of participants|||Number
666597|NCT01754519|Secondary|Disease Specific Survival|The disease specific survival will be analyzed using Kaplan-Meier method.|Up to 5 years|The study was terminated early by the IRB due to the fact that an IDE (Investigational Device Exemption) was never submitted. No outcome measure data was collected.|||||
666598|NCT01754519|Secondary|Overall Survival|The overall survival will be analyzed using Kaplan-Meier method.|Up to 5 years|The study was terminated early by the IRB due to the fact that an IDE (Investigational Device Exemption) was never submitted. No outcome measure data was collected.|||||
666599|NCT01754519|Secondary|Locoregional Control Rate|Locoregional control will be calculated with confidence interval estimates and will be compared to historical control rates.|At 5 years|The study was terminated early by the IRB due to the fact that an IDE (Investigational Device Exemption) was never submitted. No outcome measure data was collected.|||||
666600|NCT01754519|Primary|Cosmetic Differences in the Treated Breast|Will measure differences in the cosmetic size, shape, or texture of the breast. Cosmesis will be graded according to the Baker Scale. Patient reported cosmesis will also be evaluated using the Ontario Clinical Oncology Breast Cancer Questionnaire.|Up to 2 years|The study was terminated early by the IRB due to the fact that an IDE (Investigational Device Exemption) was never submitted. No outcome measure data was collected.|||||
666601|NCT01754519|Primary|Quality-of-life Assessments|Will be rated by patients using the POST-B, the Functional Assessment of Chronic Illness Therapy (FACIT), and the Skindex-16.|Up to 2 years|The study was terminated early by the IRB due to the fact that an IDE (Investigational Device Exemption) was never submitted. No outcome measure data was collected.|||||
666602|NCT01754519|Primary|Number of Patients With Adverse Events as a Measure of Safety and Tolerability|Toxicity will be assessed by the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) v 3.0.|Up to 2 years|All treated and eligible patients||Participants|||Count of Participants
666603|NCT01754493|Secondary|Somatization Module of the Patient's Health Questionnaire (PHQ-15)|Self-report 15-item scale measuring somatization symptoms (range 0-30); higher score indicates greater severity of somatization symptoms.|Measured at weeks 0, 8, 12|Sample size decreased due to attrition over course of study, N=17 at Week 0, N=12 at Week 8, N=10 at Week 12. Our primary analysis was a repeated measures mixed-methods regression that included all available data points.||units on a scale||Standard Deviation|Mean
666755|NCT01751867|Secondary|Mean Percentage of Duration of Hospitalization (Relative to Days on Study Treatment)|Duration of hospitalization was calculated as, total number of days a participant stayed in hospital during study treatment divided by the study treatment duration|Up to 2 years|Intent-to-treat (ITT) population: Participants who received at least one dose of study drug.||Percentage of total days||Standard Deviation|Mean
666604|NCT01754493|Secondary|Visual Analogue Scales (VAS)|Five self-report 11-point Likert scales measuring pain severity in the following domains (one item each): overall pain, pain interfering with daily activities, headaches, back pain, and shoulder pain. Range is 0-10; higher scores indicate higher pain severity.|Measured at weeks 0, 8, 12|Sample size decreased due to attrition over course of study, N=17 at Week 0, N=12 at Week 8, N=10 at Week 12. Our primary analysis was a repeated measures mixed-methods regression that included all available data points.||units on a scale||Standard Deviation|Mean
666605|NCT01754493|Secondary|Clinician-Rated Global Impression Scales (CGI)|Two clinician-administered scales measuring level of change in (1) depressive symptoms and (2) IBS symptoms, assessed separately. Range is 1-7, ranging from very much improved (1) to very much worsened (7).|Measured at weeks 0, 8, 12|Sample size decreased due to attrition over course of study, N=17 at Week 0, N=12 at Week 8, N=10 at Week 12. Our primary analysis was a repeated measures mixed-methods regression that included all available data points.||units on a scale||Standard Deviation|Mean
666606|NCT01754493|Primary|Gastrointestinal Symptoms Rating Scale (GSRS)|Clinician-administered 15-item scale measuring IBS symptoms (range 15-105); higher score indicates greater IBS severity.|Weeks 0, 8, 12|Sample size decreased due to attrition over course of study, N=17 at Week 0, N=12 at Week 8, N=10 at Week 12. Our primary analysis was a repeated measures mixed-methods regression that included all available data points.||units on a scale||Standard Deviation|Mean
666607|NCT01754493|Primary|Montgomery-Asberg Depression Rating Scale (MADRS)|Clinician-administered 10-item scale measuring depressive symptoms (range 0-60); higher scores indicate greater severity of major depression.|Weeks 0, 8, 12|Sample size decreased due to attrition over course of study, N=17 at Week 0, N=12 at Week 8, N=10 at Week 12. Our primary analysis was a repeated measures mixed-methods regression that included all available data points.||units on a scale||Standard Deviation|Mean
666608|NCT01754480|Secondary|Prevalence of Treatment Failures|Protocol-defined bleeding at the target bleeding site after the start of treatment or the use of alternative hemostatic treatments (with exception of reversal of heparin) or maneuvers at the target bleeding site after the start of treatment.|From start of treatment until 10 minutes after treatment start|Efficacy analysis was performed on subjects in the Primary Part (II) of the study||percent of subjects|||Number
666609|NCT01754480|Secondary|Cumulative Proportion of Subjects Having Achieved Hemostasis at the Target Bleeding Site by Specified Time Points|"Cumulative proportion of subjects having achieved hemostasis by each of the following time points:
At 2 minutes following start of study treatment
At 5 minutes following start of study treatment
At 7 minutes following start of study treatment
At 10 minutes following start of study treatment"|From start of treatment until 10 minutes after treatment start|Efficacy analysis was performed on subjects in the Primary Part (II) of the study||Percent of subjects achieving hemostasis|||Number
666610|NCT01754480|Secondary|Time to Hemostasis|Time in minutes for achievement of hemostasis at the target bleeding site measured from the start of treatment until 10 minutes after treatment start.|From start of treatment until 10 minutes after treatment start|Efficacy analysis was performed on subjects in the Primary Part (II) of the study||minutes||95% Confidence Interval|Median
666611|NCT01754480|Secondary|Proportion of Subjects Achieving Hemostasis by Three Minutes After Treatment Start|Subjects achieving hemostasis at the target bleeding site by 3 minutes following the start of treatment without the occurrence of re-bleeding until the completion of surgical closure.|From start of treatment until 3 minutes after treatment start|Efficacy analysis was performed on subjects in the Primary Part (II) of the study||Percent of subjects achieving hemostasis|||Number
666612|NCT01754480|Primary|Proportion of Subjects Achieving Hemostasis by Four Minutes After Treatment Start|Subjects achieving hemostasis at the target bleeding site by 4 minutes following the start of treatment without the occurrence of re-bleeding until the completion of surgical closure.|From start of treatment until 4 minutes after treatment start|Efficacy analysis was performed on subjects in the Primary Part (II) of the study||Percent of subjects achieving hemostasis|||Number
666613|NCT01754467|Secondary|Changes in Total Sedentary Time|Changes in total sedentary behavior will be assessed via accelerometry between baseline and 1 month|Baseline and 1 month|One individual outlier showed opposite changes as compared with the other participants and was 2.1 standard deviations above the mean for change in percent of day spent in sedentary behavior; thus this individual was excluded from this analysis.||percentage of day spent sedentary||Standard Deviation|Mean
666614|NCT01754467|Secondary|Breaks in Sedentary Behavior|Changes in the number of breaks in sedentary behavior will be assessed via accelerometry between baseline and 1 month|Baseline and 1 month|||breaks/day||Standard Deviation|Mean
666615|NCT01754467|Secondary|Adherence to NEAT!|NEAT usage (days/month)|1 Month|||days||Standard Deviation|Mean
666616|NCT01754467|Primary|Acceptability of NEAT!|How many participants would continue to use or use NEAT! in the future|1 month|||Participants|||Count of Participants
666617|NCT01754402|Secondary|Progression Free Survival|The time elapsed for patients between initiation of study therapy and either disease progression or death|up to 2 years||||||
666618|NCT01754402|Secondary|Time to Next Therapy|Time to next Therapy - defined as the time elapsed for patients from initiation of study therapy until initiation of next therapy|up to 2 years||||||
666619|NCT01754402|Secondary|Time to Progression|Time to progression - defined as time elapsed in patients between achievement of response and disease progression|up to 2 years||||||
666620|NCT01754402|Secondary|Overall Response Rate|"The number of patients achieving stable disease (SD), partial response (PR), very good partial response (VGPR), complete response (CR) or stringent complete response (sCR)
sCR = CR as defined in Primary Outcome measure 2 plus normal free light chain ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence
VGPR = Serum and urine M-protein detectable by immunofixation but not on electrophoresis or > 90% reduction in serum M-protein plus urine M-protein level < 100 mg/24 h
SD = Not meeting criteria for CR, VGPR, PR, or progressive disease"|up to 2 years||||||
666635|NCT01754259|Primary|Change in Post-exercise Coronary Vasodilator Reserve|Change (from baseline) in post-exercise coronary vasodilator reserve, as measured by PET imaging at 4 weeks post randomization. Per-patient global coronary flow reserve (CFR) was calculated as the ratio of absolute MBF at stress over rest for the entire left ventricle. Quantitation of MBF was performed by two operators blinded to patient, treatment period and treatment order.|4 weeks|||% change|||Number
666636|NCT01754194|Secondary|Surgical Complications|Incidence of procedural and post-procedural complications through 30 days post-op.|30 Days|||participants|||Number
666621|NCT01754402|Primary|Initial Response Rate|"The number of patients achieving a complete response (CR) or partial response (PR). Response is defined by the International Myeloma Working Group as:
CR- Negative immunofixation on serum and urine and disappearance of soft tissue plasmacytomas and < 5% plasma cells in bone marrow
PR- > 50% reduction of serum M-protein and urine M-protein by >90% or to < 200 mg/24 h In addition, if present at baseline, a > 50% reduction in the size of soft tissue plasmacytomas is also required
VGPR - Serum and urine M-protein detectable by immunofixation but n"|2 cycles (approximately 2 months)|The overall number of participants analyzed reflects those who received at least 2 cycles of treatment. These participants were assessed for response at that time. The data reported indicates how many patients out of each cohort experienced at least a partial response or complete response.||Participants|||Count of Participants
666622|NCT01754402|Primary|Maximum Tolerated Dose of Pomalidomide and Bendamustine|"In the phase I dose escalation portion, patients will be sequentially enrolled in 4 cohorts at dose levels in a standard 3+3 design until the maximum tolerated dose (MTD) is reached.
Cohort 1 (bendamustine 120mg/m2 + pomalidomide 3mg); Cohort 2 (bendamustine 120mg/m2 + pomalidomide 4mg); Cohort 3 (bendamustine 150mg/m2 + pomalidomide 4mg); Cohort 4 (bendamustine 180mg/m2 + pomalidomide 4mg)
If dose limiting toxicity (DLT) is observed in 2 or more of the six patients at the same dosing level while DLT is observed in only 1 or none of the 6 patients at the dosing level immediately below it, then the lower dosing level will be defined as the maximum tolerated dose (MTD)."|2 cycles (approximately 2 months)|All patients enrolled in cohort 1 and 2 evaluable for DLT. Cohorts 3 and 4 were not evaluated due to both patients in Cohort 2 experiencing DLT.||milligrams|||Number
666623|NCT01754389|Secondary|Percentage of Participants With Chronic Graft Versus Host Disease|Rates of chronic GVHD 1 year after stem cell infusion|1 year|||Percentage of participants|||Number
666624|NCT01754389|Secondary|Percentage of Participants With Progression-free and Overall Survival|Progression-free and overall survival 1 year post stem cell infusion|1 year|||Percentage of participants|||Number
666625|NCT01754389|Secondary|Percentage of Participants With Relapse|Relapse relapse-cum-immunosuppression-free survival at 1 year after stem cell infusion|1 year|||Percentage of participants||95% Confidence Interval|Number
666626|NCT01754389|Secondary|Percentage of Participants With Non-relapse Mortality|Non-relapse mortality by 1 year after stem cell infusion.|1 year|||Percentage of participants||95% Confidence Interval|Number
666627|NCT01754389|Primary|Percentage of Participants With Incidence of Grade II-IV GVHD|The primary outcome of this study is the cumulative incidence of grade II-IV acute GVHD up to Day 180 after stem cell infusion. Acute GHVD is graded according to the modified Glucksberg criteria (adapted from Thomas et al., NEJM ,1975, pp. 895-90), which is based on criteria by which the provider classifies acute GVHD per its objective organ staging. Acute GVHD is assessed in weekly standard of care visits post stem cell infusion and is captured in the protocol EDC upon evaluation of clinical notes up to Day 100. Data for acute GVHD organ staging and etiologies are collected in an acute GVHD separate case report form and do not include system organ class, expectedness or attribution.|6 months|||Percentage of participants||95% Confidence Interval|Number
666628|NCT01754376|Secondary|Ratio of CD8+ T Cells to Regulatory T Cells|Tumor samples were collected pre-treatment, after 1-2 weeks on vemurafenib alone and after administration of aldesleukin (high-dose interleukin 2, HD-IL2). Multi-parameter flow cytometry was performed to measure the frequency of regulatory T cells and of CD8+ T cells. The CD8/Treg ratio was calculated.|Up to 8 weeks from start of treatment|Tumor tissue was only analyzed from one participant||ratio CD8/T reg cells|||Number
666629|NCT01754376|Secondary|Mean Percentage of Aldesleukin Doses Received Per Participant|To assess whether the number of doses of aldesleukin that can be safely administered is affected by the co-administration of vemurafenib. The total number of planned doses of aldesleukin was 28 in each of course 1 and course 2. A participant receiving all 28 doses in course 1 would be considered as receiving 100 percent of doses.|Approximately 9 months from start of treatment|Six participants started course 1. Only 4 participants started course 2.||percentage of doses||Full Range|Mean
666630|NCT01754376|Secondary|Number of Participants Experiencing Grade 3 (Severe) Adverse Events|To determine the toxicity and safety of concurrent administration of aldesleukin and vemurafenib by assessing adverse events experienced by participants.|2 years|||Participants|||Count of Participants
666631|NCT01754376|Secondary|Overall Survival|To determine the overall survival in patients treated with aldesleukin and vemurafenib. Overall survival is defined as the time between the first administration of study drug and death due to any cause.|2 years|Median overall survival was not reached||months||Full Range|Median
666632|NCT01754376|Secondary|Overall Response Rate|To determine the overall response rate (as defined as the rate of objective response (Complete Response (CR) or Partial Response (PR)) lasting continuously for 12 or more months, and beginning at any point within 12 months of initiating therapy) in patients treated with aldesleukin and vemurafenib. In this limited cohort, response rate was calculated as the proportion of patients with partial (PR) or complete response (CR) divided by the total number of patients treated. Per Response Evaluation Criteria in Solid Tumors (RECIST v.1.1), 'Complete Response' is the disappearance of all target lesions and 'Partial Response' is at least a 30% decrease in the sum of the diameters of target lesions, as measured via CT (computed tomography). Overally Response (OR) = CR + PR.|2 years|||percentage of participants||95% Confidence Interval|Number
666633|NCT01754376|Primary|Progression Free Survival|To assess the efficacy (as measured by progression-free survival (PFS)) of patients with metastatic melanoma with V600E mutation treated with the combination of vemurafenib and aldesleukin. Progression free survival is defined as the time between the first dose of study drug and the first occurrence of progression of disease or death from any cause. Progression is defined using Response Evaluation Criteria in Solid Tumors (RECIST v.1.1), as at least a 20% increase in the sum of the diameters of target lesions or the appearance of one or more new lesions.|3 years|||weeks||95% Confidence Interval|Median
666634|NCT01754259|Secondary|Change in LV Diastolic Function|Change (from baseline) in LV diastolic function reflected primarily in mitral annular early diastolic relaxation velocity (E’) at 4 weeks post randomization. LV end-diastolic and end-systolic volumes (used to calculate LVEF), left atrial volume, septal and lateral peak early diastolic tissue velocity (e′), septal and lateral peak systolic tissue velocity (s′), and mitral inflow velocity (E) were all measured in accordance with ASE guidelines.|4 weeks|||% change|||Number
666637|NCT01754194|Secondary|Health Resource Utilization - Amount of Patients Requiring Transfer to ICU or Other Special Unit During Hospitalization||12 Months|||percentage of patients|||Number
666640|NCT01754194|Secondary|Excess Weight Loss (EWL)|"EWL, calculated as a percentage, was used to compare weight loss between patients or types of bariatric procedures instead of actual weight loss.
The formula used was: EWL = 100 × actual weight loss (lbs)/(initial weight [lbs] – IBW [lbs]), where Actual weight loss was calculated as the difference between initial/pre-operative weight (lbs) and post-operative weight (lbs) and IBW was based on the 1983 Metropolitan Height (inches) and Weight (lbs). The Aurea Under the Curve (AUC) of EWL is reported to combine repeated measurements at flexible time intervals from 0 to 12 months post-procedure into a single numeric value. The higher the AUC value is, the more the patient lost weight."|12 Months|||Percentage EWL*month||Standard Deviation|Mean
666641|NCT01754194|Primary|Quality of Life (QOL) in First Postoperative Year According to Impact of Weight on Quality of Life-Lite Questionnaire (IWQOL-Lite)|The IWQoL-Lite consists of five domains: physical function (11 items), self-esteem (7 items), sexual life (4 items), public distress (5 items), and work (4 items). Each item has five response options: never true-1, rarely true-2, sometimes true-3, usually true-4, and always true-5. In computing raw and normalized scores, a pro-rated system is used for handling missing data. Normalized scores are used to obtain scores ranging from 0 (worst QoL) to 100 (best QoL). The Aurea Under the Curve (AUC) of QOL as assessed by IWQOL-Lite questionnaire is reported to combine repeated measurements at flexible time intervals from 0 to 12 months post-procedure into a single numeric value. The higher the AUC value is, the better the patient is.|12 months|||Score*months||Standard Deviation|Mean
666642|NCT01754194|Primary|Quality of Life (QOL) in First Postoperative Year According to Bariatric Analysis and Reporting System (BAROS) With the Moorehead-Ardelt Quality of Life Questionnaire II (M-A QoLQ II)|The BAROS consists of a scoring table that includes three main areas of analysis: weight loss, improvement of medical conditions and M-A QoLQ II. Points are added or subtracted according to changes in these domains. A maximum of three points is given to each domain to evaluate changes after medical or surgical intervention. Points are deducted for complications or reoperations. The M-A QoLQ II assesses six important QoL items (self-esteem, physical activity, social life, work conditions, sexual activity and eating behaviour) on a scale ranging from -0.50 to 0.50 with 0.10 increments to assess each item. The total number of points (range -7 to 9) defines five outcome groups from failure to excellent. The Aurea Under the Curve (AUC) of QOL as assessed by BAROS with M-A QoLQ II is reported to combine repeated measurements at flexible time intervals from 0 to 12 months post-procedure into a single numeric value. The higher the AUC value is, the better the patient is.|12 months|||Score*months||Standard Deviation|Mean
666643|NCT01754194|Primary|Quality of Life (QOL) in First Postoperative Year According to EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)|The EQ-5D-5L (minimum and maximum values are 0 and 1 respectively) consists of two sections,the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).The EQ-5D descriptive system comprises the following five dimensions: mobility,self-care,usual activities (e.g.,work, study..), pain/discomfort and anxiety/depression with five response levels for each dimension:no problems,slight problems, moderate problems,severe problems and extreme problems.The EQ-5D VAS is a 20 cm vertical scale where patients can mark from 0 (worst health imaginable) to 100 (best health imaginable).The global score at each timepoint is calculated as a composite of the five dimention score and of the VAS health score according to a specific algorithm.The Aurea Under the Curve (AUC) of QOL as assessed by EQ-5D-5L is reported to combine repeated measurements at flexible time intervals between 0 and 12 months post-procedure into a single numeric value.The higher the AUC value is,the better the patient is.|12 Months|||Score*months||Standard Deviation|Mean
666644|NCT01753856|Secondary|Percentage of Eroded Surface/Bone Surface (ES/BS) in the CC, EC and IC of the Iliac Crest|ES/BS is the fraction of the entire trabecular surface occupied by resorption bays, including both those with and without osteoclasts. It is an indicator of bone resorption. Percentage = (ES/BS) *100.|3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with ES/BS assessed in the CC, EC and IC of the iliac crest.||percentage of BS||Inter-Quartile Range|Median
666645|NCT01753856|Secondary|Wall Thickness (W.Th) in the CC, EC and IC of the Iliac Crest|W.Th is the distance from the cement line to the marrow space of completed trabecular bone packets.|3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with a W. Th assessment in the CC, EC and IC of the iliac crest.||µm||Inter-Quartile Range|Median
666646|NCT01753856|Other Pre-specified|Average Length of DLs in the CC, EC, IC and PC of the Iliac Crest|The length of TET DLs is a measure of the extent of bone formation in each compartment within individual remodeling units and is measured in mm. At baseline (18 days prior to randomization / study drug administration), DEM was administered. 22 days prior to the biopsy procedure (biopsy obtained 3 months post first dose of study drug), TET was administered. New bone in the biopsy was seen as the amount of bone between the 2 fluorescently DEM- or TET-labeled lines under a microscope. A DL indicated active bone formation.|3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with an assessment of DL length in the various compartments of the iliac crest.||mm||Standard Deviation|Mean
666647|NCT01753856|Secondary|Osteoid Thickness (O.Th) in the CC, EC and IC of the Iliac Crest|O.Th is a measure of the average thickness of osteoid seams.|3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with an O.Th assessment in the CC, EC and IC of the iliac crest.||micrometers (mcm)||Inter-Quartile Range|Median
666648|NCT01753856|Secondary|Percentage of Osteoid Surface (OS)/Bone Surface (BS) in the CC, EC and IC of the Iliac Crest|OS is the percentage of the entire trabecular BS that is covered by osteoid. Percentage = (OS / BS) *100.|3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with the assessment of OS/BS in the CC, EC and IC of the iliac crest.||percentage of BS||Inter-Quartile Range|Median
666649|NCT01753856|Secondary|Percentage of Osteoid Volume (OV)/Bone Volume (BV) in the CC of the Iliac Crest|OV is the percentage of a given volume of bone tissue that consists of new unmineralized bone matrix (osteoid). Percentage = (OV/BV) *100.|3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with an assessment of OV/BV in the CC of the iliac crest.||percentage of BV||Inter-Quartile Range|Median
667101|NCT01745380|Secondary|Number of Participants With an Increase From Baseline in Systolic Blood Pressure Greater Than or Equal to 25 mm Hg and/or to a Value Higher Than 160 mm Hg||at any time within 120 minutes following drug administration|||participants|||Number
666650|NCT01753856|Secondary|Adjusted Apposition Rate (Aj.AR) in the CC, EC and IC of the Iliac Crest|Aj.AR is MAR averaged over the entire osteoid surface and in a steady state is an estimate of the mean rate of matrix apposition. At baseline (18 days prior to randomization / study drug administration), DEM was administered. 22 days prior to the biopsy procedure (biopsy obtained 3 months post first dose of study drug), TET was administered. New bone in the biopsy was seen as the amount of bone between the 2 fluorescently DEM- or TET-labeled lines under a microscope. A DL indicated active bone formation and a SL or NL suggested suppression of bone formation. BFR = MAR * (MS/BS). SL cases were imputed to a value of 0.3 µm/day or counted as missing. NL cases were counted as missing.|3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with Aj.AR assessments in the CC, EC and IC of the iliac crest.||µm/day||Inter-Quartile Range|Median
666651|NCT01753856|Secondary|Activation Frequency (Ac.f) in the CC, EC and IC of the Iliac Crest|Ac.f is the probability of new remodeling cycles initiated on the BS per year. Ac.f = (BFR/BS) / wall thickness. At baseline (18 days prior to randomization / study drug administration), DEM was administered. 22 days prior to the biopsy procedure (biopsy obtained 3 months post first dose of study drug), TET was administered. New bone in the biopsy was seen as the amount of bone between the 2 fluorescently DEM- or TET-labeled lines under a microscope. A DL indicated active bone formation and a SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing. NL cases were assigned a value of zero.|3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with Ac.f assessments in the CC, EC and IC of the iliac crest.||new cycles per year||Inter-Quartile Range|Median
666652|NCT01753856|Secondary|Percentage Change From Baseline to 1, 3, and 6 Months in Serum Carboxyterminal Cross-Linking Telopeptide of Type I Collagen (CTX)|CTX is a marker of bone turnover and is a measure of bone resorption. Percentage = (CTX value at specified time points - CTX value at baseline) / (CTX value at baseline) * 100.|Baseline, 1, 3, and 6 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and serum CTX measured at baseline and the specified time points.||percentage change in CTX||Inter-Quartile Range|Median
666653|NCT01753856|Secondary|Percentage Change From Baseline to 1, 3, and 6 Months in Serum Osteocalcin|Osteocalcin is a marker of bone turnover and a measure of osteoblast function. Percentage = (osteocalcin value at specified time points - osteocalcin value at baseline) / (osteocalcin value at baseline) * 100.|Baseline, 1, 3, and 6 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had serum osteocalcin measured at baseline and the specified time points.||percentage change in osteocalcin||Inter-Quartile Range|Median
666654|NCT01753856|Secondary|Percentage Change From Baseline to 1, 3, and 6 Months in Serum Procollagen Type I N-terminal Propeptide (P1NP)|P1NP is a marker of bone turnover and is a measure of bone formation. Percentage = (P1NP value at specified time points - P1NP value at baseline) / P1NP value at baseline * 100.|Baseline, 1, 3, and 6 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had serum P1NP measurements at baseline and the specified time points.||percentage change in P1NP||Inter-Quartile Range|Median
666655|NCT01753856|Secondary|Percentage Change From Baseline to 1, 3, and 6 Months in Intact Parathyroid Hormone (PTH)|PTH regulates calcium and phosphate metabolism in bone and kidney, and is typically measured in serum using the intact PTH assay. Percentage = (PTH value at specified time points - PTH value at baseline) / PTH value at baseline * 100.|Baseline, 1, 3, and 6 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had serum PTH assessed at baseline and the specified time points.||percentage change in PTH||Inter-Quartile Range|Median
666656|NCT01753856|Secondary|Percentage of Single or Double Tetracycline Labels Per Bone Surface (sLS/BS or dLS/BS) in the CC, EC, IC and PC of the Iliac Crest Bone Biopsies|At baseline (18 days prior to randomization / study drug administration), DEM was administered. 22 days prior to the biopsy procedure (biopsy obtained 3 months post first dose of study drug), TET was administered. New bone in the biopsy was seen as the amount of bone between the 2 fluorescently DEM- or TET-labeled lines under a microscope. A DL indicated active bone formation and a SL or NL suggested suppression of bone formation. Percentage = (Single or double TET labels / BS) *100.|3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with label surface measured in the specified compartments of the iliac crest.||percentage of TET label||Inter-Quartile Range|Median
666657|NCT01753856|Secondary|Change From Baseline to 3 Months in Bone Formation Rate/Bone Surface (BFR/BS ) in the CC, EC, IC and PC of the Iliac Crest Bone Biopsies|BFR/BS is the volume of mineralized bone formed per unit surface of bone per unit of time [mm cubed per mm squared per year (mm³/mm²/year)]. At baseline (18 days prior to randomization / study drug administration), DEM was administered. 22 days prior to the biopsy procedure (biopsy obtained 3 months post first dose of study drug), TET was administered. New bone in the biopsy was seen as the amount of bone between the 2 fluorescently DEM- or TET-labeled lines under a microscope. A DL indicates active bone formation, a SL or NL suggests suppression of bone formation. BFR = MAR * (MS/BS). SL cases were imputed to a value of 0.3 mcm/day or counted as missing. NL cases were assigned a value of zero.|Baseline, 3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with BFR/BS assessments in the specified compartments of the iliac crest.||mm³/mm²/year||Inter-Quartile Range|Median
666658|NCT01753856|Secondary|Change From Baseline to 3 Months in Mineral Apposition Rate (MAR) in the CC, EC, IC and PC of the Iliac Crest Bone Biopsies|MAR is a measure of the linear rate of production of mineralized bone matrix by osteoblasts and is measured by the mean distance between 2 consecutive labels divided by the time interval. At baseline (18 days prior to randomization / study drug administration), DEM was administered. 22 days prior to the biopsy procedure (biopsy obtained 3 months post first dose of study drug), TET was administered. New bone in the biopsy was seen as the amount of bone between the 2 fluorescently DEM- or TET-labeled lines under a microscope. A DL indicated active bone formation, and a SL or NL suggested suppression of bone formation. SL cases were imputed to a value of 0.3 micrometers per day (µm/day) or counted as missing. NL cases were reported as missing.|Baseline, 3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with an evaluation of MAR in the CC, EC, IC and PC of the iliac crest.||mcm/day||Inter-Quartile Range|Median
666659|NCT01753856|Secondary|Change From Baseline to 3 Months in Label Length Within Each Basic Multicellular Unit (BMU) in the CC, EC, IC and PC of the Iliac Crest Bone Biopsies|BMUs are local groups of osteoblasts and osteoclasts that act in concert to complete a single remodeling cycle. The label length is a measure of the extent of the mineralization front within each BMU in the CC, EC, IC and PC. At baseline (18 days prior to randomization / study drug administration), DEM was administered. 22 days prior to the biopsy procedure (biopsy obtained 3 months post first dose of study drug), TET was administered. New bone in the biopsy was seen as the amount of bone between the 2 fluorescently DEM- or TET-labeled lines under a microscope. A DL indicated active bone formation, and a SL or NL suggested suppression of bone formation.|Baseline, 3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with label lengths measured in the specified compartments of the iliac crest.||millimeters (mm)||Inter-Quartile Range|Median
666660|NCT01753856|Secondary|Percentage of Overfilled Remodeling Sites in the CC, EC and PC of the Iliac Crest Bone Biopsies|The percentage of overfilled remodeling sites in the CC, EC, and PC were defined as the percentage of observed remodeling units in which the second DL (TET) extended beyond the limits of the scalloped reversal line and into the adjacent, previously unresorbed surface of the bone. Percentage = (overfilled remodeling bone formation unit / total bone formation unit) * 100.|3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy evaluated for overfilled remodeling sites in the specified compartments of the iliac crest.||percentage of overfilled remodeling site||Inter-Quartile Range|Median
666661|NCT01753856|Secondary|Percentage of Mineralizing Surface With Remodeling-Based Formation and Modeling-Based Formation in the CC, EC and PC of the Iliac Crest Bone Biopsies|"The percentage of mineralizing surface where post-treatment DLs in the CC, EC, and PC were classified as remodeling-based or modeling based bone formation based on collagen fiber orientation and whether the underlying reversal line was scalloped or smooth.
Percentage = percentage remodeling- or modeling-based formation units * MS/BS"|3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with the classification of TET DLs as remodeling- or modeling-based formation in the specified compartments of the iliac crest.||percentage of the total formation unit||Full Range|Median
666662|NCT01753856|Secondary|Percentage of Bone With Remodeling-Based and Modeling-Based Formations in the CC, EC and PC of the Iliac Crest Bone Biopsies|In this study, post-treatment DLs in the CC, EC, and PC were classified as remodeling-based or modeling-based bone formations which was determined by whether the underlying reversal line was scalloped or smooth and by the collagen fiber orientation. Percentage = (remodeling-based formation units or modeling-based formation units/ total bone formation units) * 100.|3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with the classification of TET DLs as remodeling-based or modeling-based formation in the specified compartments of the iliac crest.||percentage of the total formation unit||Inter-Quartile Range|Median
666663|NCT01753856|Secondary|MS/BS in the CC, EC, IC and PC of the Iliac Crest Bone Biopsies 3 Months Post First Dose of Study Drug|MS /BS is a measure of the proportion of BS on which new mineralized bone is deposited at the time of DEM or TET labeling and is calculated as the sum of the total extent of DL plus half the extent of SL divided by BS. At baseline (18 days prior to randomization / study drug administration), DEM was administered (3 days on, 12 days off, 3 days on). 22 days prior to the biopsy procedure (biopsy obtained 3 months post first dose of study drug), TET was administered (same dosing schedule as DEM). Both DEM and TET temporarily bind to new bone and fluoresce under UV light. New bone in the biopsy was seen as the amount of bone between the 2 fluorescently DEM- or TET-labeled lines under a microscope. A DL indicated active bone formation and a SL or NL suggested varying degrees of suppression of bone formation.|3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with MS/BS measurements in the specified compartments of the iliac crest.||percentage of BS||Inter-Quartile Range|Median
666664|NCT01753856|Secondary|Change From Baseline to 3 Months in MS/BS in the Endocortical Compartment (EC), Intracortical Compartment (IC), and Periosteal Compartment (PC) of the Iliac Crest Bone Biopsies|MS /BS is a measure of the proportion of BS on which new mineralized bone is deposited at the time of DEM or TET labeling and is calculated as the sum of the total extent of DL plus half the extent of SL divided by BS. At baseline (18 days prior to randomization / study drug administration), DEM was administered (3 days on, 12 days off, 3 days on). 22 days prior to the biopsy procedure (biopsy obtained 3 months post first dose of study drug), TET was administered (same dosing schedule as DEM). Both DEM and TET temporarily bind to new bone and fluoresce under UV light. New bone in the biopsy was seen as the amount of bone between the 2 fluorescently DEM- or TET-labeled lines under a microscope. A DL indicated active bone formation and a SL or NL suggested varying degrees of suppression of bone formation.|Baseline, 3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with MS/BS measurements in the specified compartments of the iliac crest.||percentage of BS||Inter-Quartile Range|Median
666665|NCT01753856|Secondary|Number of Samples With Single or Double Tetracycline Labels, SL and DL, or No Tetracycline Labels in the CC, Endocortical Compartment (EC), Intracortical Compartment (IC) and Periosteal Compartment (PC) of the Iliac Crest Bone Biopsies||3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with an assessment of the number of samples with specified labels in the various compartments of the iliac crest.||Samples|||Number
666682|NCT01753518|Secondary|Surgeon Satisfaction (Per Procedure)|"Surgeon satisfaction was assessed by a 3-question questionnaire immediately after performing the procedure. The questions were: How satisfied are you with the appearance of the skin incision? How willing are you to recommend this skin closure (whether it was staples or suture) to a patient? How willing are you to use this skin closure (whether it was staples or suture) for your next cesarean section? There were 5 possible responses to each question (not at all, not very, no opinion, somewhat, extremely), with not at all,' not very, and no opinion being a negative response, and somewhat and extremely  being a positive response. Categories reported were negative, (including no opinion), and positive."|Immediately after the procedure (day 1)|A satisfaction survey wasn't completed for all of the procedures (103 per arm), so the reporting population is 91 for the suture arm, and 96 for the staple arm.||Surgeons reporting per category|||Number
666666|NCT01753856|Primary|Change From Baseline to 3 Months in Mineralizing Surface (MS) /Bone Surface (BS) in the Cancellous Compartment (CC) of the Iliac Crest Bone Biopsies|MS /BS is a measure of the proportion of BS on which new mineralized bone is deposited at the time of DEM or TET labeling, and calculated as the sum of the total extent of double label (DL) plus half the extent of single label (SL) divided by BS. At baseline (18 days prior to randomization / study drug administration), DEM was administered (3 days on, 12 days off, 3 days on). 22 days prior to the biopsy procedure (biopsy obtained 3 months post first dose of study drug), TET was administered (same dosing schedule as DEM). Both DEM and TET temporarily bind to new bone and fluoresce under UV light. New bone in the biopsy was seen as the amount of bone between the 2 fluorescently DEM- or TET-labeled lines under a microscope. A DL indicated active bone formation and a SL or no label (NL) suggested varying degrees of suppression of bone formation.|Baseline, 3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with MS/BS measurements in the CC of the iliac crest.||percentage of BS||Inter-Quartile Range|Median
666667|NCT01753713|Other Pre-specified|Changes From Baseline in Circulating Growth Factors and Soluble Receptors.|To assess the pharmacodynamic effect of dovitinib on potential plasma biomarkers that may include measuring concentrations of circulating, microparticles, PlGF, PDGF-AA, PDGF-AB, PDGF-BB, SDF-la, thrombospondin-l, Angl, and 11-6, IL-8 and FGF.|Up to 30 days after treatment||||||
666668|NCT01753713|Secondary|Overall Survival|The Kaplan-Meier method will be used. Overall survival is defined as the time from randomization to death.|to death, approximately 2 years|||Months||95% Confidence Interval|Median
666669|NCT01753713|Secondary|Median Progression Free Survival|The progression- free survival (PFS) at 6 months is defined as the time from randomization to objective tumor progression or death. So patients who have CR, PR or SD at 6 months will constitute PFS-6|6 months|||Months||95% Confidence Interval|Median
666670|NCT01753713|Secondary|Objective Response Rate Using Modified Revised Assessment in Neuro-Oncology (RANO) Criteria|Number of patients (both populations) with a complete response (CR-no measurable disease), partial response (PR >50% reduction in measurable disease), minor response (MR >25% reduction of measurable disease), stable disease (SD <25% reduction) and progressive disease (PD >25% measurable disease and new lesions).|Up to 30 days after treatment|||Participants|||Count of Participants
666671|NCT01753713|Secondary|Toxicity Assessed Using Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0|Number of adverse events in patients in both populations (grade 1-5). Grade 1 are defined as mild events characterized as asymptomatic or mild symptoms; clinical or diagnostic observations only; no intervention indicated. Grade 2 are moderate events with minimal, local or non invasive interventions indicated. Grade 3 are severe or medically significant events but not immediately life-threatening; hospitalization indicated. Grade 4 are life-threatening consequences with urgent intervention indicated. Grade 5 are deaths related to events|Assessed until 30 days after treatment up to 32 weeks|||Events|||Number
666672|NCT01753713|Primary|Arm 2: Determine Median Time to Progression|Anti-angiogenic therapy (including anti-VEGF therapy or bevacizumab) patients with recurrent glioblastoma (GBM). Time to tumor progression (TTP), is defined as the time from randomization to time of progressive disease. So it is ongoing and will be assessed every 8 weeks …8, 16, 24, 32 …week. Progression is defined as >25% increase in size of lesions or evidence of new lesions|From randomization to time of progression every 8 weeks (2 cycles of treatment) up to 32 weeks|||Months||95% Confidence Interval|Median
666673|NCT01753713|Primary|Arm 1: Progression Free Survival (PFS)|Number of anti-angiogenic therapy (including anti-VEGF therapy or bevacizumab) naive patients with recurrent glioblastoma (GBM). The progression- free survival (PFS) at 6 months is defined as the time from randomization to objective tumor progression or death. So patients who have CR, PR or SD at 6 months will constitute PFS-6. Progression is defined using the Response Assessment in Neuro-Oncology (RANO) Criteria where CR = Total disappearance of lesions, PR = >50% reduction in lesions and SD = <25% reduction in lesions|6 months|||Participants|||Count of Participants
666674|NCT01753557|Secondary|Viral Sequencing at the Non-structural 3 Protease Region of HCV Virus（Result of Resistance-associated Variants Analysis)||From baseline to 24 weeks after completion of drug administration|||participants|||Number
666675|NCT01753557|Secondary|Transition of Serum HCV RNA Levels||baseline，Day2，Day3，1Weeks，2Weeks，3Weeks，4Weeks，End of treatment，Follow-up 12weeks，Follow-up 24weeks|||log IU/mL||Inter-Quartile Range|Median
666676|NCT01753557|Secondary|Undetectable HCV RNA at 12 Weeks After Completion of Drug Administration||36 weeks|||percentage of subjects achieving SVR12||95% Confidence Interval|Number
666677|NCT01753557|Secondary|Undetectable HCV RNA at Completion of Drug Administration (ETR, End-of-treatment Response)||24 weeks|||percentage of subjects achieving ETR||95% Confidence Interval|Number
666678|NCT01753557|Secondary|Undetectable HCV RNA at 4 Weeks After Beginning of Drug Administration (RVR, Rapid Viral Response)||4 weeks|||percentage of subjects achieving RVR||95% Confidence Interval|Number
666679|NCT01753557|Primary|Undetectable HCV (Hepatitis C Virus) RNA (Ribonucleic Acid) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)||48 weeks|||percentage of subjects achieving SVR||95% Confidence Interval|Number
666680|NCT01753518|Secondary|Cosmetic Outcome|The cosmetic outcome will be assessed by patients and a blinded observer at the 6 week postpartum/postoperative exam using the Patient Observer Scar Assessment Scale (POSAS). The POSAS consists of two parts: a Patient Scale and an Observer Scale. Both scales contain six items that are scored numerically. Each item of both scales has a 10-point score, with 10 indicating the worst imaginable scar or sensation. The lowest score is ‘1’, and corresponds to the situation of normal skin (normal pigmentation, no itching etc), and goes up to the worst imaginable. Besides the six items the ‘Overall Opinion’ of the scar quality is scored separately of both patients and observers. Again, a 10-point scale is used in which 10 corresponds to the worst imaginable scar.|Measured at 6 week postoperative appointment|Not all patients or observers completed the scales. For the six items on the patient scale, N=44:52, but the overall opinion responding was N=43:51. For the observer scale the number responding was N=43:52 for vascularity, thickness, pliability, and surface area. N=42:52 for pigmentation and relief; N=42:50 for overall opinion.||units on a scale||Inter-Quartile Range|Mean
666681|NCT01753518|Primary|Skin Closure Time, All Resident Levels|Measured for all resident education levels (1 to 4 years postgraduate).|Measured at the time of the procedure (day 1), approximately 1 hour after incision start|Intention-to-Treat||minutes||Inter-Quartile Range|Median
666683|NCT01753518|Secondary|Patient Satisfaction|Patient satisfaction was measured by questionnaire at the time of dismissal from the hospital and at their 6 week postpartum/postoperative exam. There were 4 questions: How satisfied are you with the appearance of your skin incision? How willing are you to recommend this same skin closure to a friend? How willing are you to have this same skin closure for your next cesarean section? What is your overall satisfaction with your surgical procedure, including the skin incision? For reporting purposes, possible answers for each item were grouped into negative (not at all, not very, or no opinion), or positive (somewhat or extremely).|At the time of dismissal (typically day 3 or 4) and at 6 weeks postoperative appointment|The reduction in the number of participants analyzed is due to not all participants completing the questionnaire, and all the questions. For appearance of incision, N=58:69. For willingness to use treatment again, N=59:68.||participants|||Number
666684|NCT01753518|Secondary|Number of Subjects Requiring Patient-controlled, Alternative Oral, or Single Dose IV/IM Analgesic|Post-operative pain was assessed by pain medication use through chart review. These subjects required patient-controlled analgesia, or alternative oral analgesic, or a single dose of intravenous (IV) or intramuscular (IM) analgesic. Alternative oral analgesics included hydromorphone, hydrocodone/acetaminophen, or oxycodone/acetaminophen .|From day of procedure until end of hospital stay (typical dismissal on day 4)|||participants|||Number
666685|NCT01753518|Secondary|Postoperative Pain|Post-operative pain was assessed by pain medication use through chart review.|From day of procedure until end of hospital stay (typical dismissal on day 4)|||mg||Inter-Quartile Range|Median
666686|NCT01753518|Secondary|Participants With Postoperative Complications, by Type|Postoperative complications were assessed by chart review.|From the day of the procedure (Day 1) for 6 weeks|Participants could have experienced more than one type of postoperative complication. Note: wound dehiscence is a surgical complication in which a wound ruptures along surgical suture. A seroma is a pocket of clear serous fluid. A hematoma is a localized swelling that is filled with blood caused by a break in the wall of a blood vessel.||participants|||Number
666687|NCT01753518|Secondary|Total Number of Participants With Postoperative Complications|Postoperative complications were assessed by chart review.|From the day of the procedure (Day 1) for 6 weeks|The number of participants analyzed was reduced because some patients did not return for postpartum followup visits.||participants|||Number
666688|NCT01753518|Primary|Total Surgical Time, All Resident Levels|Total surgical time was defined as the time from incision start to incision completion. Measured for all resident education levels (1 to 4 years postgraduate).|Measured at the time of the procedure (day 1), approximately 1 hour after incision start|Intention-to-Treat||minutes||Inter-Quartile Range|Median
666689|NCT01753336|Secondary|TWSTRS Pain Subscale Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3.|Mean TWSTRS pain subscale scores for Week 4 and Week 12 of treatment cycles 1, 2 and 3 are presented. The mean difference in the TWSTRS pain subscale scores from treatment cycle baseline (defined as Day 1 in each cycle) at the Week 4 and Week 12 visits for Treatment Cycles 1, 2 and 3 are also presented. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The pain subscale gives a score from 0 to 20, with higher values indicating greater pain experienced. The score was assessed by the investigator at baseline and at all post-treatment visits of each treatment cycle.|Week 4 and 12 of treatment cycles 1, 2 and 3 (12 - 16 weeks duration each)|The safety population included all subjects who received at least 1 dose of study treatment, regardless of the amount of study treatment administered, and who had at least 1 safety record post-treatment or attended a post-treatment visit.||units on a scale||Standard Deviation|Mean
666690|NCT01753336|Secondary|TWSTRS Disability Subscale Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3.|Mean TWSTRS disability subscale scores for Week 4 and Week 12 of treatment cycles 1, 2 and 3 are presented. The mean difference in the TWSTRS disability subscale scores from treatment cycle baseline (defined as Day 1 in each cycle) at the Week 4 and Week 12 visits for Treatment Cycles 1, 2 and 3 are also presented. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The disability subscale is a 6-item scale and each item is rated on a 6-point scale with higher values indicating the highest degree of disability. The score was assessed by the investigator at baseline and at all post-treatment visits of each treatment cycle.|Weeks 4 and 12 of treatment cycle 1, 2 and 3 (12 - 16 weeks duration each)|The safety population included all subjects who received at least 1 dose of study treatment, regardless of the amount of study treatment administered, and who had at least 1 safety record post-treatment or attended a post-treatment visit.||units on a scale||Standard Deviation|Mean
666691|NCT01753336|Secondary|TWSTRS Severity Subscale Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3.|Mean TWSTRS severity subscale scores for Week 4 and Week 12 of treatment cycles 1, 2 and 3 are presented. The mean differences in the TWSTRS severity subscale scores from treatment cycle baseline (defined as Day 1 in each cycle) at the Week 4 and Week 12 visits for treatment cycles 1, 2 and 3 are also presented. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The severity subscale gives a score from 0 to 35, with higher values indicating a worse outcome of physical findings of CD. The score was assessed by the investigator at baseline and at all post-treatment visits of each treatment cycle.|Weeks 4 and 12 of treatment cycle 1, 2 and 3 (12 - 16 weeks duration each)|The safety population included all subjects who received at least 1 dose of study treatment, regardless of the amount of study treatment administered, and who had at least 1 safety record post-treatment or attended a post-treatment visit.||units on a scale||Standard Deviation|Mean
666702|NCT01753323|Secondary|AUC0-48h - Part 2|AUC0-48h was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose.|Day 1|Pharmacokinetic (PK) analysis set analysis set for Cohort 3: The PK set for Cohort 3 included participants who received at least one dose of study medication except for 1 participant who was withdrawn on Day 1 and 3 participants who vomited before 3 hours.||hr*ng/mL||Standard Error|Mean
667102|NCT01745380|Secondary|Number of Participants With a Heart Rate Lower Than 50 Bpm||at any time within 120 minutes following drug administration|||participants|||Number
666692|NCT01753336|Secondary|Treatment Response in Treatment Cycle 3 Week 4.|Treatment response was defined as a reduction in the TWSTRS total score of at least 30% from pretreatment baseline to the Week 4 visit in Treatment Cycle 3. The pretreatment baseline scores were defined as the TWSTRS measurement before Dysport® treatment in Study 169 for subjects who had previously received Dysport® in Study 169 and Day 1 of Study 170 for those subjects who had previously received placebo. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The score was assessed by the investigator prior to study treatment at baseline for Studies 169 and 170 and at all post-treatment visits of each treatment cycle. The proportion (percentage) of subjects who were treatment responders at Week 4 of Treatment Cycle 3 are presented.|Week 4 Treatment Cycle 3|The safety population included all subjects who received at least 1 dose of study treatment, regardless of the amount of study treatment administered, and who had at least 1 safety record post-treatment or attended a post-treatment visit. For Treatment Cycle 3 there were 91 evaluable subjects.||percentage of participants||95% Confidence Interval|Number
666693|NCT01753336|Secondary|TWSTRS Total Scores at Pretreatment Baseline, Week 4 and Week 12 for Treatment Cycles 1, 2 and 3.|The pretreatment baseline scores were defined as the TWSTRS measurement before Dysport® treatment in Study 169 for subjects who had received Dysport® in Study 169 and Day 1 of Study 170 for those subjects who had received placebo. Mean TWSTRS total scores for pretreatment baseline and for Week 4 and Week 12 of treatment cycles 1, 2 and 3 are presented. The mean differences in the TWSTRS total scores from pretreatment baseline scores at Week 4 and Week 12 of each treatment cycle are also presented. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The score was assessed by the investigator prior to study treatment at baseline for Studies 169 and 170 and at all post-treatment visits of each treatment cycle.|Week 4 and 12 of treatment cycles 1, 2 and 3 (12 - 16 weeks duration each)|The safety population included all subjects who received at least 1 dose of study treatment, regardless of the amount of study treatment administered, and who had at least 1 safety record post-treatment or attended a post-treatment visit.||units on a scale||Standard Deviation|Mean
666694|NCT01753336|Primary|TWSTRS Total Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3.|Mean TWSTRS total scores for Week 4 and Week 12 of treatment cycles 1, 2 and 3 are presented. The mean differences in the TWSTRS total scores from treatment cycle baseline (defined as Day 1 in each cycle) at the Week 4 and Week 12 visits for Treatment Cycles 1, 2 and 3 are also presented. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The score was assessed by the investigator at baseline and at all post-treatment visits of each treatment cycle.|Week 4 and 12 of treatment cycles 1, 2 and 3 (12 - 16 weeks duration each)|The safety population included all subjects who received at least 1 dose of study treatment, regardless of the amount of study treatment administered, and who had at least 1 safety record post-treatment or attended a post-treatment visit.||units on a scale||Standard Deviation|Mean
666695|NCT01753323|Secondary|Vz/F - Part 2|Vz/F was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose.|Day 1|Pharmacokinetic (PK) analysis set analysis set for Cohort 3: The PK set for Cohort 3 included participants who received at least one dose of study medication except for 1 participant who was withdrawn on Day 1 and 3 participants who vomited before 3 hours.||Liters||Standard Deviation|Mean
666696|NCT01753323|Secondary|CL/F - Part 2|CL/F was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose.|Day 1|Pharmacokinetic (PK) analysis set analysis set for Cohort 3: The PK set for Cohort 3 included participants who received at least one dose of study medication except for 1 participant who was withdrawn on Day 1 and 3 participants who who vomited before 3 hours.||L/hr||Standard Deviation|Mean
666697|NCT01753323|Secondary|T1/2 - Part 2|T1/2 was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose.|Day 1|Pharmacokinetic (PK) analysis set analysis set for Cohort 3: The PK set for Cohort 3 included participants who received at least one dose of study medication except for 1 participant who was withdrawn on Day 1 and 3 participants who vomited before 3 hours.||hours||Standard Deviation|Mean
666698|NCT01753323|Secondary|Tmax - Part 2|Tmax was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose.|Day 1|Pharmacokinetic (PK) analysis set analysis set for Cohort 3: The PK set for Cohort 3 included participants who received at least one dose of study medication except for 1 participant who was withdrawn on Day 1 and 3 participants who vomited before 3 hours.||hours||Full Range|Median
666699|NCT01753323|Secondary|Cmax - Part 2|Cmax was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose.|Day 1|Pharmacokinetic (PK) analysis set analysis set for Cohort 3: The PK set for Cohort 3 included participants who received at least one dose of study medication except for 1 participant who was withdrawn on Day 1 and 3 participants who vomited before 3 hours.||ng/mL||Standard Deviation|Mean
666700|NCT01753323|Secondary|AUCinf - Part 2|AUCinf was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose|Day 1|Pharmacokinetic (PK) analysis set analysis set for Cohort 3: The PK set for Cohort 3 included participants who received at least one dose of study medication except for 1 participant who was withdrawn on Day 1 and 3 participants who vomited before 3 hours.||hr*ng/mL||Standard Deviation|Mean
666701|NCT01753323|Secondary|AUClast - Part 2|AUClast was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose|Day 1|Pharmacokinetic (PK) analysis set analysis set for Cohort 3: The PK set for Cohort 3 included participants who received at least one dose of study medication except for 1 participant who was withdrawn on Day 1 and 3 participants who vomited before 3 hours.||hr*ng/mL||Standard Deviation|Mean
667103|NCT01745380|Secondary|Number of Participants With a Heart Rate Higher Than 125 Bpm||at any time within 120 minutes following drug administration|||participants|||Number
666703|NCT01753323|Secondary|AUC0-24h - Part 2|AUC0-24h was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose.|Day 1|Pharmacokinetic (PK) analysis set analysis set for Cohort 3: The PK set for Cohort 3 included participants who received at least one dose of study medication except for 1 participant who was withdrawn on Day 1 and 3 participants who vomited before 3 hours.||hr*ng/mL||Standard Error|Mean
666704|NCT01753323|Secondary|Accumulation Ratio (Racc) (=AUC0-24h, day3/AUC0-24h, day1) - Part 1|Racc was analyzed using parent drug in plasma samples. On day 3, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose.|Day 3|Pharmacokinetic (PK) analysis set for Cohorts 1 and 2: The PK set included all participants who received at least one dose of study medication except for 1 participant from Cohort 1, who was excluded due to a protocol deviation.||ratio||Standard Deviation|Mean
666705|NCT01753323|Secondary|Apparent Volume of Distribution During the Terminal Elimination Phase Following Extravascular Administration (Vz/F) - Part 1|Vz/F was analyzed using parent drug in plasma samples. On Day 3, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose.|Day 3|Pharmacokinetic (PK) analysis set for Cohorts 1 and 2: The PK set included all participants who received at least one dose of study medication except for 1 participant from Cohort 1, who was excluded due to a protocol deviation.||Liters||Standard Deviation|Mean
666706|NCT01753323|Secondary|Clearance (CL/F ) - Part 1|CL/F was analyzed using parent drug in plasma samples. On day 3, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose.|Day 3|Pharmacokinetic (PK) analysis set for Cohorts 1 and 2: The PK set included all participants who received at least one dose of study medication except for 1 participant from Cohort 1, who was excluded due to a protocol deviation.||L/hr||Standard Deviation|Mean
666707|NCT01753323|Secondary|Half-life (T1/2) - Part 1|T1/2 was analyzed using parent drug in plasma samples. On day 3, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose.|Day 3|Pharmacokinetic (PK) analysis set for Cohorts 1 and 2: The PK set included all participants who received at least one dose of study medication except for 1 participant from Cohort 1, who was excluded due to a protocol deviation.||hr||Standard Deviation|Mean
666708|NCT01753323|Secondary|Area Under the Curve (AUC)Inf - Part 1|AUCinf was analyzed using parent drug in plasma samples. On Day 3, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose.|Day 3|Pharmacokinetic (PK) analysis set for Cohorts 1 and 2: The PK set included all participants who received at least one dose of study medication except for 1 participant from Cohort 1, who was excluded due to a protocol deviation.||hr*ng/mL||Standard Deviation|Mean
666709|NCT01753323|Secondary|Area Under the Curve (AUC)Last - Part 1|AUClast was analyzed using parent drug in plasma samples. On Day 3, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose.|Day 3|Pharmacokinetic (PK) analysis set for Cohorts 1 and 2: The PK set included all participants who received at least one dose of study medication except for 1 participant from Cohort 1, who was excluded due to a protocol deviation.||hr*ng/mL||Standard Error|Mean
666710|NCT01753323|Secondary|Time to Maximum Concentration (Tmax) - Part 1|Tmax was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose. The 24h sampling of first post dose should be taken before the second dose. On Day 3, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose.|Days 1 and 3|Pharmacokinetic (PK) analysis set for Cohorts 1 and 2: The PK set included all participants who received at least one dose of study medication except for 1 participant from Cohort 1, who was excluded due to a protocol deviation.||hour||Full Range|Median
666711|NCT01753323|Secondary|Maximum Concentration (Cmax) - Part 1|Cmax was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose. The 24h sampling of first post dose should be taken before the second dose. On Day 3, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose.|Days 1 and 3|Pharmacokinetic (PK) analysis set for Cohorts 1 and 2: The PK set included all participants who received at least one dose of study medication except for 1 participant from Cohort 1, who was excluded due to a protocol deviation.||ng/mL||Standard Error|Mean
666712|NCT01753323|Secondary|Area Under the Curve (AUC)0-24h - Part 1|AUC0-24h was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose. The 24h sampling of first post dose was taken before the second dose. On Day 3, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose.|Days 1 and 3|Pharmacokinetic (PK) analysis set for Cohorts 1 and 2: The PK set included all participants who received at least one dose of study medication except for 1 participant from Cohort 1, who was excluded due to a protocol deviation.||(hr*ng/mL)||Standard Deviation|Mean
666713|NCT01753323|Primary|28-day Cure Rate - Part 2|28-day cure rate was defined as the percentage of participants with blood parasite count of zero after 28 days of treatment.|Day 28|Intent-to-treat analysis set: the intent-to-treat analysis set included all randomized participants who received at least one dose of study medication.||Percentage of participants|||Number
666714|NCT01753323|Primary|Time to Parasite Clearance|Parasite clearance was determined by assessing the parasite count in blood, using thin film, thick film and blood density assessments.|Day 5|Pharmacodynamic (PD) analysis set for Cohorts 1, 2 and 3: The PD set included all participants who received at least one dose of study medication except for 1 participant from Cohort 1, who was excluded due to a protocol deviation, and 1 participant from Cohort 3, who was withdrawn on Day 1.||Hours||95% Confidence Interval|Median
666742|NCT01752855|Secondary|Percentage of Participants Positive for Anti-adalimumab Antibody|Percentage of participants with anti-adalimumab antibody|Week 24 through Week 48|All participants who received at least one dose of study drug.||percentage of participants|||Number
666756|NCT01751867|Secondary|Transfusion Independence: Number of Participants Who Were Transfusion Independent|A participant was considered to be transfusion independent, if the participant had no transfusions of Red Blood Cells (RBCs) or platelets for 8 consecutive weeks or more.|Baseline; up to 2 years|Intent-to-treat (ITT) population: Participants who received at least one dose of study drug. Here, 'n' is the number of participants analyzed at specified time point.||Participants|||Number
667325|NCT01741350|Primary|Female Condom Skills (0-100%)|Participants' HIV risk reduction behavioral skills were assessed based on the percentage of correct necessary steps demonstrated to properly select and apply a female condom using a replica.|Baseline|||percentage of correct steps||Standard Error|Mean
666715|NCT01753310|Secondary|Change From Baseline in CDIP-58 Total Score at Week 2.|The CDIP-58 scale is a subject-based rating scale measuring the health impact of CD measured in 8 health dimensions including head and neck symptoms, pain and discomfort, upper limb activities, walking, sleep, annoyance, mood and psychosocial functioning. Subscale scores were transformed to a common theoretical range of 0 (no impact) to 100 (most impact). Negative changes from the baseline total score indicate improvement in the impact of CD on health whereas postive changes indicate worsening. The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint (change from baseline in CDIP-58 total score at Week 4) reached a statistically significant treatment effect. This secondary efficacy endpoint (change from baseline in CDIP-58 total score at Week 2) was performed to characterise the full clinical effect.|2 weeks post-treatment|The ITT population consisted of all randomised subjects. Only subjects with data available at the point of testing are reported. A total of 8 subjects (6 from the Dysport® arm and 2 from the Placebo arm) had missing values for CDIP-58.||units on a scale||Standard Deviation|Mean
666716|NCT01753310|Secondary|Change From Baseline in Cervical Dystonia Impact Profile-58 (CDIP-58) Total Score at Week 4.|The CDIP-58 scale is a subject-based rating scale measuring the health impact of CD measured in 8 health dimensions including head and neck symptoms, pain and discomfort, upper limb activities, walking, sleep, annoyance, mood and psychosocial functioning. Subscale scores were transformed to a common theoretical range of 0 (no impact) to 100 (most impact). Negative changes from the baseline total score indicate improvement in the impact of CD on health whereas postive changes indicate worsening.|4 weeks post-treatment|The ITT population consisted of all randomised subjects. Only subjects with data available at the point of testing are reported. A total of 8 subjects (7 from the Dysport® arm and 1 from the Placebo arm) had missing values for CDIP-58.||units on a scale||Standard Deviation|Mean
666717|NCT01753310|Secondary|TWSTRS Responders at Week 4.|Treatment response was determined as the number of responders at Week 4 relative to the baseline TWSTRS total score. A treatment responder is defined as a subject who had at least a 30% reduction in the TWSTRS total score after treatment. This was calculated as ([Week 4 score - baseline score]/baseline score) * 100.|4 weeks post-treatment|The ITT population consisted of all randomised subjects.||percentage of participants||95% Confidence Interval|Number
666718|NCT01753310|Secondary|Change From Baseline in CGIC in CD at Week 4.|The CGIC is an investigator-reported assessment of the global clinical change in CD since study treatment administration. The CGIC uses a seven-point Likert scale ranging from +3 (very much improved) to -3 (very much worse), and was assessed by the investigator at the Week 2 and Week 4 visits.|4 weeks post-treatment|The ITT population consisted of all randomised subjects. Only subjects with data available at the point of testing are reported. A total of 3 subjects (all from the Dysport® arm) had missing values for CGIC.||units on a scale||Standard Deviation|Mean
666719|NCT01753310|Secondary|TWSTRS Responders at Week 2.|Treatment response was determined as the number of responders at Week 2 relative to the baseline TWSTRS total score. A treatment responder is defined as a subject who had at least a 30% reduction in the TWSTRS total score after treatment. This was calculated as ([Week 2 score - baseline score]/baseline score) * 100.|2 weeks post-treatment|The ITT population consisted of all randomised subjects.||percentage of participants||95% Confidence Interval|Number
666720|NCT01753310|Secondary|Change From Baseline in Clinical Global Impression of Change (CGIC) in CD at Week 2.|The CGIC is an investigator-reported assessment of the global clinical change in CD since study treatment administration. The CGIC uses a seven-point Likert scale ranging from +3 (very much improved) to -3 (very much worse), and was assessed by the investigator at the Week 2 and Week 4 visits.|2 weeks post-treatment|The ITT population consisted of all randomised subjects. Only subjects with data available at the point of testing are reported. A total of 4 subjects (3 from the Dysport® arm and 1 from the Placebo arm) had missing values for CGIC.||units on a scale||Standard Deviation|Mean
666721|NCT01753310|Secondary|Change From Baseline in TWSTRS Total Score at Week 2.|The change from baseline in the TWSTRS total score at Week 2 was determined for the subjects who received a single dose of Dysport® or placebo by intramuscular injection at the baseline visit (Day 1), and is expressed as weighted overall treatment difference. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The score was assessed by the investigator prior to study treatment at baseline and at all post-treatment visits.|2 weeks post-treatment|The ITT population consisted of all randomised subjects.||units on a scale||Standard Deviation|Mean
666722|NCT01753310|Primary|Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score at Week 4.|The change from baseline in the TWSTRS total score at Week 4 was determined for the subjects who received a single dose of Dysport® or placebo by intramuscular injection at the baseline visit (Day 1), and is expressed as weighted overall treatment difference. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The score was assessed by the investigator prior to study treatment at baseline and at all post-treatment visits.|4 weeks post-treatment|The modified ITT population consisted of all randomised subjects with both a baseline and a Week 4 post-treatment TWSTRS total score assessment.||units on a scale||Standard Deviation|Mean
666723|NCT01753115|Secondary|Geometric Mean Titer (GMT) of Toxin Neutralizing Antibody (TNA) Levels|Blood was collected in arms 1 and 2 at day 48 ( 2 weeks following last vaccination) and in arm 3 at day 43 ( 2 weeks following last vaccination) for TNA assay to determine the NF50 antibody titer for calculating GMT.|Two weeks after last vaccination|BioThrax immunogenicity population: received 3 vaccinations and had samples taken within the study-specified windows; had a valid immunogenicity result within 2 wks of the last vaccination; had no evidence of previous anthrax vaccination and received the correct BioThrax dose at all 3 times; received vaccine maintained at the proper temperature.||titer||95% Confidence Interval|Geometric Mean
666724|NCT01753115|Primary|Ratios of Ciprofloxacin Area Under the Curve and Cmax (Day 5/Day 44)|Ratios of Area Under the Curve from zero to 12 hours (AUC0-12h) and maximum concentration (Cmax) achieved for ciprofloxacin (Day 5/Day 44).|Day 5 and Day 44 in Arm 1|Per protocol population: all subjects in arm 1 who received any dose of ciprofloxacin, had adequate PK data on Day 5 and Day 44, had received all three BioThrax doses, and who had no key protocol deviations (e.g., insufficient blood sample) that would be expected to affect the ciprofloxacin PK assessment.||ratio||90% Confidence Interval|Mean
666725|NCT01753076|Secondary|Change From Baseline in the Amyotrophic Lateral Sclerosis Assessment Questionnaire-40 (ALSAQ-40) Total Score at Week 48|The ALSAQ-40 is a disease specific health status assessment for individuals with ALS/motor neuron disease. The ALSAQ-40 is comprised of 40 questions measuring 5discrete dimensions of health status that are affected by the disease: physical mobility (10 items); activities of daily living and independence (10 items); eating and drinking (3 items); communication (7 items); emotional reactions (10 items). Participants were asked to indicate the frequency of each event by selecting one of five options (Likert scale: 0-4): never/rarely/sometimes/often/ always or cannot do at all. The total score (minimum possible score=0, maximum possible score=160) was calculated by adding the five domain scores. A low score indicates a better health state. Change from Baseline was calculated by subtracting the derived Baseline value from the post-Baseline value. A mixed-model repeated measures adjusted for treatment, Visit, Treatment by Visit, and Baseline ALSAQ-40 total score was used for the analysis.|Baseline and Week 48|ITT Population. Only participants with data available at the specified time points were analyzed||Scores on a scale||Standard Error|Least Squares Mean
666726|NCT01753076|Secondary|Change From Baseline in the EuroQol 5 Dimensions-5 Level Short Form (EQ-5D-5L) Utility Score at Week 48|A utility score for each participant was calculated based on the value set for England. The Week 0 (Visit 2) value was considered to be the Baseline value. Change from Baseline was calculated by subtracting the derived Baseline value from the post-Baseline value. EQ-5D-5L is a standardized, participant-rated instrument for use as a measure of health outcomes. The EQ 5D-5L includes 2 components: the EQ-5D-5L descriptive system and the EQ-Visual Analog Scale (EQ-VAS). The EQ-5D-5L descriptive system provides a profile of the participant’s health state in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). . For each of these dimensions, the participant self assigned a score: 1 (no problems); 2 (slight problems); 3 (moderate problems); 4 (severe problems); 5 (extreme problems).Minimum score on scale was 1 and maximum score was 5 for each dimension. A negative change from Baseline indicates improvement.|Baseline and Week 48|ITT Population. Only participants with data available at the specified time points were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
666727|NCT01753076|Secondary|Progression-free Survival at Week 48|Progression-free survival at Week 48 is defined as the time from randomization to progression (decline of at least six points on the ALSFRS-R from Baseline) or death or censored at Week 48, whichever comes first. Kaplan Meier estimates at Week 48 were evaluated at Day 344. A participant was considered to have completed if he/she was censored at Day 344. Confidence intervals were estimated using the Brookmeyer Crowley method. Results are shown as the estimated percentage of participants alive and without disease progression at Week 48.|Week 48|ITT Population. Only on-treatment data (data within 21 days of the last dose) were analyzed.||Percentage of participants surviving||95% Confidence Interval|Number
666728|NCT01753076|Secondary|Overall Survival at Week 48 and Week 60|Overall survival is defined as the time from randomization to death or censoring at the time point of analysis, whichever comes first. Kaplan Meier estimates at Week 48 were evaluated at Day 344. A participant was considered to have completed if he/she was censored at Day 344. Kaplan Meier estimates at Week 60 were evaluated at Day 428. A participant was considered to have completed if he/she was censored at Day 428. Confidence intervals were estimated using the Brookmeyer Crowley method. Results are shown as the estimated percentage of participants alive at Weeks 48 and 60. Week 48: Only on-treatment data (data within 21 days of the last dose) were analyzed. Week 60: Including off treatment data (data after 21 days after the last dose) were analyzed.|Week 48 and Week 60|ITT Population||Percentage of participants||95% Confidence Interval|Number
666729|NCT01753076|Secondary|Number of Clinical Global Impression-improvement Scale (CGI-I) Responders at Week 48|The CGI-I scale is a single observer-rated item measuring global improvement relative to Baseline. The CGI-I score is rated on a 7-point scale, from 1 (very much improved) to 7 (very much worse). Participant status at Baseline was assessed using the Clinical Global Impression Severity scale (CGI-S), which is a 7-point scale (1: normal, not at all ill; 7: most extremely ill) used to rate the severity of the participant's illness. Participants achieving a score of 1-4 in the CGI-I at Week 48 were considered to be responders. A a logistic regression adjusted for CGI-S at Baseline, riluzole use, and world region was used for the analysis.|Week 48|ITT Population. Only participants with data available at the specified time points were analyzed.||Participants|||Number
666730|NCT01753076|Secondary|Change From Baseline in Muscle Strength as Measured by Hand Held Dynamometry (HHD) Score at Week 48|The HHD is a device placed between the hand of the practitioner and the tested body part and provides a quantified measurement of muscle strength. Each muscle was tested twice, and both values were recorded. Additionally, a third trial could have been performed if the variability between the first two trials was greater than 15 % or if the rater thought that one of the first two trials was not valid. The Week 0 (Visit 2) value was considered to be the Baseline value. Percent change from Baseline for each muscle group was calculated as 100*(HHD score minus the Baseline score) divided by the Baseline score. The average percent change was the mean percent change across the muscle groups that were non-missing/non-zero at Baseline. MMRM adjusted for treatment, visit, treatment by visit, number of non-missing/non-zero muscle groups at Baseline, number of non-missing/non-zero muscle groups at Baseline by Visit, riluzole use, and country group was used for the analysis.|Baseline and Week 48|ITT Population. Only participants with data available at the specified time points were analyzed.||Percent change||Standard Error|Least Squares Mean
666731|NCT01753076|Secondary|Change From Baseline in Slow Vital Capacity (SVC) at Week 48|SVC was measured by using a validated spirometer. Three SVC measurements were performed for each participant at each assessment provided the difference from the second trial (if arranged by the numerical value) was not greater than 10%. If the difference between the best and the next best (based on the largest numerical value) SVC value from the first three trials was greater than 10%, additional trials (up to 5 in total) could have been performed. The Week 0 (visit 2) value was considered to be the Baseline value. Change from Baseline was calculated by subtracting the derived Baseline value from the post-Baseline value. A mixed-model repeated measures (MMRM) adjusted for treatment, visit, treatment by visit, Baseline SVC, Baseline SVC by visit, riluzole use. and country group was used for the analysis.|Baseline and Week 48|ITT population. Only those participants available at indicated time points were analyzed.||Liters (L)||Standard Error|Least Squares Mean
666816|NCT01751087|Secondary|Complications From Procedure|Patient having any complication, including hospitalizations transfusions additional unplanned procedures|assessed immediately after completion of D&E and at 1 week and 1 month post-procedure|||participants|||Number
666732|NCT01753076|Secondary|Rate of Decline Over Week 48 in the ALSFRS-R Total Score|The rate of decline was estimated by the change from Baseline in ALSFRS-R. The monthly slope for the ALSFRS-R score (i.e., the monthly rate of decline) was calculated as change from Baseline in the ALSFRS-R score at the last visit for that treatment period divided by the study day at the last visit for that treatment period devided by 30.4. The Week 0 (Visit 2) value was considered to be the Baseline value. Change from Baseline was calculated by subtracting the derived Baseline value from the post-Baseline value. The ALSFRS-R was a quickly administered (5 min) ordinal rating scale used to determine a participant's assessment of their capability and independence in 12 functional activities. There were 12 questions, graded by the participant 0-4 (4 is normal). Score of 0 (worst) to 48 (best). Reflects speech and swallowing, fine motor skills, large motor skills, and breathing.|Baseline to Week 48|ITT Population. Only on-treatment data (data within 21 days of the last dose) were analyzed..||change in scores on a scale per month||Standard Error|Least Squares Mean
666733|NCT01753076|Secondary|Change From Baseline in the ALSFRS-R Total Score at Week 48|The rate of decline was estimated by the change from Baseline in ALSFRS-R. The monthly slope for the ALSFRS-R score (i.e., the monthly rate of decline) was calculated as change from Baseline in the ALSFRS-R score at the last visit for that treatment period divided by the study day at the last visit for that treatment period /30.4. The Week 0 (Visit 2) value was considered to be the Baseline value. Change from Baseline was calculated by subtracting the derived Baseline value from the post-Baseline value. The ALSFRS-R was a quickly administered (5 min) ordinal rating scale used to determine a participant's assessment of their capability and independence in 12 functional activities. There were 12 questions, graded by the participant 0-4 (4 is normal). Score of 0 (worst) to 48 (best). Reflects speech and swallowing, fine motor skills, large motor skills, and breathing.|Baseline and Week 48|ITT Population. Only on-treatment data (data within 21 days of the last dose) were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
666734|NCT01753076|Primary|Joint Rank Scores for Combined Analysis of Function (Amyotrophic Lateral Sclerosis Functional Rating Scale Revised [ALSFRS-R] Score) and 48 Week Overall Survival|The joint rank score is a combined assessment of function and survival. Function is assessed using change from Baseline in the ALSFRS-R total score. To calculate joint rank scores, every participant was compared with all other participants in a pair wise manner and assigned a score of -1, 0 or 1 based on their relative outcomes. A subject's joint rank score is the sum of their scores across the pair wise comparisons. The . The ALSFRS-R was a quickly administered (5 min) ordinal rating scale used to determine a participant's assessment of their capability and independence in 12 functional activities. There were 12 questions, graded by the participant 0-4 (4 is normal). Score of 0 (worst) to 48 (best). Reflects speech and swallowing, fine motor skills, large motor skills, and breathing. Lower scores of ALSFRS-R reflect greater impairment.|Week 48|ITT population. Only on-treatment data (data within 21 days of the last dose) were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
666735|NCT01752907|Secondary|Percentage of Participants Who Used Analgesics for the Treatment of Bone Pain by Cycle and Across Cycles|Analgesic use includes both analgesic and non-steroidal anti-inflammatory drugs.|From Day 1 of Cycle 2 until 30 days after the last dose of pegfilgrastim, up to approximately 16 weeks.|Full analysis set||percentage of participants|||Number
666736|NCT01752907|Secondary|Percentage of Participants With Grade 3 or 4 Bone Pain Captured in Standard Adverse Event Reporting|"Participants with grade 3 or 4 bone pain as captured during standard adverse event reporting. A pre-defined list of Medical Dictionary for Regulatory Activities (MedDRA) version 17.1 preferred terms was used to determine if a participant experienced bone pain: Arthralgia, Arthritis, Back pain, Bone pain, Chest discomfort, Groin discomfort, Limb discomfort, Musculoskeletal chest pain, Musculoskeletal discomfort, Musculoskeletal pain, Neck pain, Non-cardiac chest pain, Osteochondritis Pain, Pain in extremity, Pain in jaw, Pelvic pain, Pubic pain, Sacroiliitis, Spinal pain, Spondylitis. The severity of each AE was graded using the Common Terminology criteria for Adverse Events (CTCAE) version 3 and are based on the following:
Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE; Grade 5 = Death related to AE."|From randomization until 30 days after the last dose of pegfilgrastim, up to approximatley 20 weeks.|Full analysis set||percentage of participants|||Number
666737|NCT01752907|Secondary|Percentage of Participants With Any Grade Bone Pain as Captured in Standard Adverse Event Reporting|Participants with any grade of bone pain as captured during standard adverse event (AE) reporting. A pre-defined list of Medical Dictionary for Regulatory Activities (MedDRA) version 17.1 preferred terms was used to determine if a participant experienced bone pain: Arthralgia, Arthritis, Back pain, Bone pain, Chest discomfort, Groin discomfort, Limb discomfort, Musculoskeletal chest pain, Musculoskeletal discomfort, Musculoskeletal pain, Neck pain, Non-cardiac chest pain, Osteochondritis Pain, Pain in extremity, Pain in jaw, Pelvic pain, Pubic pain, Sacroiliitis, Spinal pain, Spondylitis.|From randomization until 30 days after the last dose of pegfilgrastim, up to approximately 20 weeks|Full analysis set||percentage of participants|||Number
666738|NCT01752907|Secondary|Patient-reported Bone Pain Area Under the Curve (AUC) by Cycle and Across All Cycles|Patient-reported bone pain AUC was calculated using the trapezoidal rule with bone pain scores from Day 1-5 for each cycle. AUC may range from 0 to 40 per cycle.|Days 1-5 for 4 treatment cycles|Full analysis set with imputation||units on a scale * days||Standard Error|Mean
666739|NCT01752907|Secondary|Mean Patient-reported Bone Pain by Cycle and Across All Cycles|Participants completed a brief bone pain survey once per day for 5 days beginning the day they received their pegfilgrastim injection. The bone pain survey collected the severity of pain using a 0 to 10 scale, where 0 = no pain and 10 indicates worst pain.|Days 1-5 for 4 treatment cycles|Full analysis set with imputation||units on a scale||Standard Error|Mean
666740|NCT01752907|Secondary|Maximum Patient-reported Bone Pain by Cycle and Across All Cycles|Participants completed a brief bone pain survey once per day for 5 days beginning the day they received their pegfilgrastim injection. The bone pain survey collected the severity of pain using a 0 to 10 scale, where 0 = no pain and 10 indicates worst pain.|Days 1-5 for each treatment cycle|Full analysis set with imputation||units on a scale||Standard Deviation|Mean
666741|NCT01752907|Primary|Maximum Patient-reported Bone Pain in Cycle 1|Participants completed a brief bone pain survey once per day for 5 days beginning the day they received their pegfilgrastim injection. The bone pain survey collected the severity of pain using a 0 to 10 scale, where 0 = no pain and 10 indicates worst pain.|Days 1 to 5 during cycle 1.|Full analysis set with imputation||units on a scale||Standard Error|Mean
666743|NCT01752855|Primary|Mean Change From Baseline in Health Assessment Questionnaire (HAQ-DI) at Weeks 36 and 48|The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. The minimal clinically important difference (MCID) defined for the HAQ-DI is 0.22. HAQ remission indicating normal physical function is defined by HAQ-DI < 0.5.|Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48|Data from participants receiving the new formulation of adalimumab in Study NCT01712178 were analyzed for 44 and 43 participants, respectively, at weeks 36 and 48. Data for the participants receiving the current formulation of adalimumab in Study NCT01712178 were analyzed for 43 participants at week 36 and 40 participants at week 48.||units on a scale||Standard Deviation|Mean
666744|NCT01752855|Primary|Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Weeks 36 and 48|"American College of Rheumatology 50% (ACR50) response. A participant is a responder if the following 3 criteria for improvement from baseline are met:
≥ 50% improvement in tender joint count;
≥ 50% improvement in swollen joint count; and
≥ 50% improvement in at least 3 of the 5 following parameters:
Physician global assessment of disease activity
Patient global assessment of disease activity
Patient assessment of pain
Disability Index of the Health Assessment
CRP (Acute phase reactant (Erythrocyte sedimentation rate/C-reactive protein))"|Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48|All participants who received at least one dose of study drug.||percentage of participants|||Number
666745|NCT01752855|Primary|Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Weeks 36 and 48|"American College of Rheumatology 20% (ACR20) response. A participant is a responder if the following 3 criteria for improvement from baseline are met:
≥ 20% improvement in tender joint count;
≥ 20% improvement in swollen joint count; and
≥ 20% improvement in at least 3 of the 5 following parameters:
Physician global assessment of disease activity
Patient global assessment of disease activity
Patient assessment of pain
Disability Index of the Health Assessment
CRP (Acute phase reactant (Erythrocyte sedimentation rate/C-reactive protein))"|Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48|All participants who received at least one dose of study drug.||percentage of participants|||Number
666746|NCT01752855|Primary|Mean Change From Baseline in Disease Activity Score 28 (DAS28) at Weeks 36 and 48|The Disease Activity Score (DAS28) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.|Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48|All available data were included. If a participant did not have a value for a given time of evaluation, but did have a value at times previous to this after the study drug treatment began, the last available value was used to replace the missing value.||units on a scale||Standard Deviation|Mean
666747|NCT01752023|Secondary|Tumor Necrosis|To assess changes in tumor necrosis in response to cisplatin and gemcitabine with or without SUBATM-itraconazole.|2 years.|Study closed due to early stopping rule. There were only 3 patients enrolled which were therefore not analyzed.|||||
666748|NCT01752023|Secondary|Itraconazole Exposure Parameters|To correlate itraconazole exposure parameters with median time to progression and median survival in this patient population.|2 years.|Study closed due to early stopping rule. There were only 3 patients enrolled which were therefore not analyzed.|||||
666749|NCT01752023|Secondary|Adverse Effects|To characterize the adverse effects of cisplatin and gemcitabine with or without SUBATM-itraconazole in this patient population.|2 years.|Study closed due to early stopping rule. There were only 3 patients enrolled which were therefore not analyzed.|||||
666750|NCT01752023|Secondary|Median Time to Progression|To determine the median time to progression and median duration of survival of patients with metastatic squamous non-small cell lung cancer treated with cisplatin and gemcitabine with or without SUBATM-itraconazole.|2 years.|Study closed due to early stopping rule. There were only 3 patients enrolled which were therefore not analyzed.|||||
666751|NCT01752023|Primary|Tumor Blood Flow.|To assess the changes in tumor blood flow as measured by contrast enhanced MRI scanning in patients with metastatic squamous non-small cell lung cancer treated with cisplatin and gemcitabine with or without SUBATM-itraconazole.|6 weeks.|Study closed due to early stopping rule. There were only 3 patients enrolled which were therefore not analyzed.|||||
666752|NCT01752023|Primary|Objective Response Rates|Per response evaluation criteria in solid tumors criteria|6 weeks|Trial closed due to early stopping rule, patients were not analyzed as there were only 3 patients enrolled.|||||
666753|NCT01751867|Secondary|Mean Change From Baseline to End of Treatment in Scores of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire – Core 30 (EORTC QLQ C-30) Physical Functioning Scale|"EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer patients. It is composed of 30 items, multi-item measure (28 items) and 2 single-item measures. For the multiple item measure, 4-point scale is used and the score for each item range from 1 = not at all to 4 = very much. Higher scores indicate worsening. The 2 single-item measure involves question about the overall health and overall quality of life which will be rated on a 7-point scale ranging from 1 = very poor to 7 = excellent. Lower scores indicate worsening. Scores are averaged, and transformed to 0-100 scale; higher score=better level of physical functioning."|Baseline to end of treatment (approximately up to 2 years)|Intent-to-treat (ITT) population- Participants who received at least one dose of study drug. The missing data was imputed by the Last Observation Carried Forward (LOCF).||Scores on a scale||Standard Deviation|Mean
666754|NCT01751867|Secondary|Overall Survival Rate: Percentage of Participants Who Survived During 6 Months and 12 Months of Treatment.||From the date of dosing until death or lost to follow-up for up to 2.5 years after last patient was enrolled|Intent-to-treat (ITT) population- Participants who received at least one dose of study drug.||Percentage of participants||95% Confidence Interval|Number
667954|NCT01732835|Secondary|Mean Gradient - Change From Baseline|Transthoracic echocardiography parameter|Baseline and 6 months|Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.||mm Hg||Standard Deviation|Mean
666757|NCT01751867|Secondary|Cytogenetic Response Rate: Percentage of Participants Who Achieved Cytogenetic Response (Complete+Partial) by Status of Clinical Overall Response - International Working Group (IWG) 2006 Response Criteria|As per IWG 2006 response criteria - Complete cytogenetic response: disappearance of the chromosomal abnormality without appearance of new ones; Partial cytogenetic response: At least 50% reduction of the chromosomal abnormality. Status of Clinical response - complete remission (CR); marrow CR (mCR); partial remission (PR).|From the date of first dose until 30 to 42 days after the last dose of the 2 years treatment period, or at time of discontinuation|Participants who had baseline cytogenetic abnormality and had at least one post baseline cytogenetic assessments during study.||Percentage of Participants|||Number
666758|NCT01751867|Secondary|Hematological Improvement Rate: Number of Participants Who Achieved Complete Remission (CR), Partial Remission (PR) and Hematologic Improvement (HI) - International Working Group (IWG) 2006 Response Criteria|IWG 2006 response criteria - CR: bone marrow evaluation shows <= 5% blasts; normal maturation of all cells lines (mCR), peripheral blood evaluation shows hemoglobin >= 11 g/dL, neutrophils >= 1000/mL, platelets >= 100,000/mL, 0% blasts; PR: Same as CR, except blasts decrease by >= 50%, still greater than 5% in bone marrow; HI: hemoglobin increase of >= 1.5 g/dL, platelet increase of >= 30,000/mL (starting with > 20,000/mL), neutrophils increase of >= 100% and > 500/μL.|From the date of first dose until 30 to 42 days after the last dose of the 2 years treatment period, or at time of discontinuation|Intent-to-treat (ITT) population- Participants who received at least one dose of study drug.||Participants|||Number
666759|NCT01751867|Primary|Overall Response Rate (ORR): Number of Participants Who Achieved Either Complete Remission (CR), Partial Remission (PR), or Marrow Complete Remission (mCR) - International Working Group (IWG) 2006 Response Criteria|IWG 2006 response criteria - CR: bone marrow evaluation shows less than or equal to (<=) 5% blasts; normal maturation of all cells lines (mCR), peripheral blood evaluation shows hemoglobin >= 11 gram per deciliter (g/dL), neutrophils >= 1000/mL, platelets >= 100,000/mL, 0% blasts; PR: Same as CR, except blasts decrease by >=50%, still greater than 5% in bone marrow.|From the date of first dose until 30 to 42 days after the last dose of the 2 years treatment period, or at time of discontinuation|Intent-to-treat (ITT) population: Participants who received at least one dose of study medication.||Participants|||Number
666760|NCT01751802|Secondary|Safety Summary of Ecopipam in Patients With Lesch-Nyhan Disease: Total Number of Serious and Non-Serious Adverse Events Experienced During 3 Double-blind Crossover Periods|An additional objective of the study is to assess the safety of ecopipam in subjects with LND for up to 52 weeks. Total number of serious and non-serious adverse events experienced by participants while receiving ecopipam or placebo. For additional detail, see Adverse Events|Total duration over which participants recieved double-blind ecopipam or placebo, up to 6 or 12 weeks|All participants who received at least one dose||adverse events|||Number
666761|NCT01751802|Secondary|Effect of Ecopipam Withdrawal and Maintenance|The secondary objectives of this study are to assess the effect of withdrawal and maintenance of ecopipam's effects in subjects with LND. Measured by the number of participants whose score changes significantly from baseline on ecopipam or placebo|Baseline, 6 weeks, 12 weeks, 18 weeks|0 participants analyzed because data are not reliable|||||
666762|NCT01751802|Primary|Behavior Problems Inventory - Self-Injurious Behavior Subscale|The primary endpoint is the BPI (SIB subscales - total for frequency and severity) as assessed by the caregiver. BPI Self-Injurious Behavior Subscale ranges from 0 to 45, with higher scores indicating more self-injurious behavior.|Baseline, end of period 1 (6 weeks), end of period 2 (12 weeks), end of period 3 (18 weeks),|All participants who completed the BPI-Self Injurious Behavior survey for 3 or more time points||scores on a scale||Standard Deviation|Mean
666763|NCT01751724|Other Pre-specified|Number of Infants With Severe Retinopathy of Prematurity|Severe retinopathy of prematurity defined as stage 3 or higher|From enrollment until 36 weeks postmenstrual age, discharge or death|||Participants|||Count of Participants
666764|NCT01751724|Other Pre-specified|Number of Infants With Severe Intraventricular Hemorrhage|Severe intraventricular hemorrhage defined as grade III or higher|From enrollment until 36 weeks postmenstrual age, discharge or death|||Participants|||Count of Participants
666765|NCT01751724|Other Pre-specified|Number of Infants With Septicemia|Septicemia defined as positive blood culture|From enrollment until 36 weeks postmenstrual age, discharge or death|||Participants|||Count of Participants
666766|NCT01751724|Other Pre-specified|Number of Infants With Necrotizing Enterocolitis||From enrollment until 36 weeks postmenstrual age, discharge or death|||Participants|||Count of Participants
666767|NCT01751724|Other Pre-specified|Number of Infants With Pulmonary Hemorrhage||From enrollment until 36 weeks postmenstrual age, discharge or death|||Participants|||Count of Participants
666768|NCT01751724|Secondary|Survival Without BPD|Discharge alive without BPD. BPD defined as need for oxygen for at least 28 days and at 36 weeks post-menstrual age.|From the time of randomization until 36 weeks corrected age, discharge or death|||Participants|||Count of Participants
666769|NCT01751724|Secondary|Number of Infants With Bronchopulmonary Dysplasia (BPD)|BPD defined as need for oxygen for at least 28 days and at 36 weeks post-menstrual age.|Evaluated at 36 weeks corrected postmenstrual age|Infants alive at 36 weeks postmenstrual age||Participants|||Count of Participants
666770|NCT01751724|Secondary|Total Duration of Oxygen Supplementation||From the time of first initiation until the last day of oxygen supplementation, up to 36 weeks corrected age|Infants alive at 36 weeks postmenstrual age||days||Inter-Quartile Range|Median
666771|NCT01751724|Secondary|Total Duration of Mechanical Ventilation||From the time of first intubation until the last extubation, up to 36 weeks corrected age|Infants alive at 36 weeks postmenstrual age||days||Inter-Quartile Range|Median
666772|NCT01751724|Secondary|Survival||From the time of randomization up to 36 weeks corrected age, or until the time of discharge or death|||Participants|||Count of Participants
666773|NCT01751724|Primary|Age at First Successful Extubation|Defined as age of extubation with infant remaining extubated for more than 24 hours.|From birth to until 36 weeks postmenstrual age|||days||Inter-Quartile Range|Median
666774|NCT01751386|Primary|Total Amount of Alcohol Consumed During the Alcohol Self Administration (ASA) Session|Amount of alcohol was measured as the number of mini-drinks each participant decided to drink (0-8 mini-drinks). The alcohol content of each mini-drink was calculated based on the participants' total body water, and was designed to raise the blood alcohol concentration by 0.015 g/dL.|2 hours|The analysis included all subjects who took the medication (either baclofen or placebo) and finished the alcohol laboratory session||mini-drinks||Standard Error|Mean
666775|NCT01751308|Secondary|Phase 2: Overall Survival (OS)|OS was defined as the time (in months) from the date of first dose administration until the date of death (from any cause). If death was not observed, the participant was censored at the earliest of the last date the participant was known to be alive and the study cut-off date. The analysis was performed by Kaplan-Meier method.|Baseline up to death or study cut-off (maximum duration: 12.1 weeks)|Analysis was performed on efficacy evaluable population. Number of participants analyzed=participants with available data for this endpoint.||months||95% Confidence Interval|Median
666776|NCT01751308|Secondary|Phase 2: Progression Free Survival (PFS)|The PFS was defined as the time (in months) from the date of first dose administration until the date of first documented PD or death (from any cause), whichever came first. If progression or death was not observed, the participant was censored at the date of the participant’s last progression-free tumor assessment prior to the study cut-off date. PD as per RANO criteria was defined as ≥25% increase in the product of perpendicular diameters of any target lesion, taking as reference the smallest product observed since the start of treatment or the appearance of one or more new lesions, or worsening neurologic status not explained by causes unrelated to tumor progression (example, anticonvulsant or corticosteroid toxicity, electrolyte disturbances, sepsis, hyperglycemia, presumed post-therapy swelling etc) plus any increase in tumor cross-sectional area (or tumor volume). The analysis was performed by Kaplan-Meier method.|Baseline, every 9 weeks until DP or death due to any cause (maximum duration: 12.1 weeks)|Analysis was performed on efficacy evaluable population. Number of participants analyzed=participants with available data for this endpoint.||months||95% Confidence Interval|Median
666777|NCT01751308|Secondary|Phase 1 and 2: PK Parameter of Cabazitaxel: Maximum Plasma Concentration Observed (Cmax)|Blood samples for PK parameters were collected at 5 minutes before EOI, 10 minutes, 30 minutes, 3 hours, 7 hours and 71 hours after the EOI on Day 1 of Cycle 1.|Day 1 of Cycle 1: 5 minutes before EOI up to 71 hours after the EOI|Analysis was performed on PK population (for both Phase 1 and Phase 2 parts of the study). Number of participants analyzed=participants with available data for this endpoint.||ng/mL||Standard Deviation|Mean
666778|NCT01751308|Secondary|Phase 1 and 2: PK Parameter of Cabazitaxel: Volume of Distribution at Steady State (Vss)|Blood samples for PK parameters were collected at 5 minutes before EOI, 10 minutes, 30 minutes, 3 hours, 7 hours and 71 hours after the EOI on Day 1 of Cycle 1.|Day 1 of Cycle 1: 5 minutes before EOI up to 71 hours after the EOI|Analysis was performed on PK population (for both Phase 1 and Phase 2 parts of the study). Number of participants analyzed=participants with available data for this endpoint.||L/m^2||Standard Deviation|Mean
666779|NCT01751308|Secondary|Phase 1 and 2: PK Parameter of Cabazitaxel: Total Plasma Clearance (CL)|Blood samples for PK parameters were collected at 5 minutes before EOI, 10 minutes, 30 minutes, 3 hours, 7 hours and 71 hours after the EOI on Day 1 of Cycle 1.|Day 1 of Cycle 1: 5 minutes before EOI up to 71 hours after the EOI|Analysis was performed on PK population (for both Phase 1 and Phase 2 parts of the study). Number of participants analyzed=participants with available data for this endpoint.||L/h/m^2||Standard Deviation|Mean
666780|NCT01751308|Secondary|Phase 1 and 2: Pharmacokinetics (PK) Parameter of Cabazitaxel: Area Under the Plasma Concentration (AUC) Versus Time Curve|Blood samples for PK parameters were collected at 5 minutes before end of infusion (EOI), 10 minutes, 30 minutes, 3 hours, 7 hours and 71 hours after the EOI on Day 1 of Cycle 1.|Day 1 of Cycle 1: 5 minutes before EOI up to 71 hours after the EOI|PK population (for both Phase 1 and Phase 2 parts of the study) included all participants who received treatment on Day 1 of Cycle 1 and had at least one post-dose PK sample. Number of participants analyzed=participants with available data for this endpoint.||ng.h/mL||Standard Deviation|Mean
666781|NCT01751308|Secondary|Phase 1: Number of Participants With Objective Response|OR in participants was defined as the participants with a CR or PR after 3 cycles of cabazitaxel treatment and maintained for at least 4 weeks as assessed by response evaluation criteria in solid tumors (RECIST) version 1.1 and RANO criteria for CNS tumors. For solid tumors, as per RECIST 1.1, CR defined as disappearance of all target and non-target lesions (any pathological lymph nodes, must had reduction in short axis to <10 mm); PR defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. For CNS tumors, as per RANO criteria, CR defined as disappearance of all target and non-target lesions; PR defined as a ≥50% decrease in the sum of the products of the two perpendicular diameters of target lesions, compared to baseline measurement.|Baseline, every 9 weeks until DP or death due to any cause (maximum duration: 112.1 weeks)|Analysis was performed on efficacy evaluable population. Number of participants analyzed=participants with available data for this endpoint.||participants|||Number
666782|NCT01751308|Secondary|Phase 1 and 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs)|AE was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had a causal relationship with the treatment. Treatment emergent adverse events (TEAEs) were defined as AEs that developed or worsened in grade or became serious during the on-treatment period which was defined as the period from the time of first dose of cabazitaxel until 30 days following the last administration of cabazitaxel.|Baseline up to DP or death due to any cause (maximum duration: 112.1 weeks for Phase 1 and 12.1 weeks for Phase 2)|Analysis was performed on safety population (AT population).||participants|||Number
666783|NCT01751308|Primary|Phase 2: Duration of Response (DOR)|DOR defined as time (in days) from date of first response until date of first documented progressive disease (PD) or death (from any cause), whichever came first. If progression or death was not observed, participant was censored at the date of participant’s last progression-free tumor assessment prior to study cut-off date. PD as per RANO criteria was defined as ≥ 25% increase in the product of perpendicular diameters of any target lesion, taking as reference the smallest product observed since the start of treatment or the appearance of one or more new lesions, or worsening neurologic status not explained by causes unrelated to tumor progression (example, anticonvulsant or corticosteroid toxicity, electrolyte disturbances, sepsis, hyperglycemia, presumed post-therapy swelling etc.) plus any increase in tumor cross-sectional area (or tumor volume).|Baseline, every 9 weeks until DP or death due to any cause (maximum duration: 12.1 weeks)|Due to no objective responses in Stage 1 of Phase 2, the analysis of duration of response was not performed.Hence, the data is not reported.|||||
666817|NCT01751087|Secondary|Ease of Mechanical Dilation|Number of participants for whom, if additional mechanical dilation was required, it was difficult or very difficult. Assessed on day of procedure. Assessed after completion of D&E|participants were assessed for the duration of the procedure, an average of 6 minutes|Number of participants in each arm who required additional mechanical dilation||participants|||Number
666784|NCT01751308|Primary|Phase 2: Percentage of Participants With Objective Response (OR)|OR in participants was defined as the participants with a Complete Response (CR) or Partial Response (PR) after 3 cycles of cabazitaxel treatment and maintained for at least 4 weeks. CR and PR were based on modified response assessment in neuro-oncology (RANO) criteria for participants with CNS tumors. CR was defined as disappearance of all target lesions. PR was defined as ≥50% decrease in the sum of the products of the two perpendicular diameters of target lesions, compared to the baseline measurement.|Baseline, every 9 weeks until DP or death due to any cause (maximum duration: 12.1 weeks)|Efficacy evaluable population was subset of AT population with measurable disease with a baseline and at least one post-baseline tumor evaluation.Number of participants analyzed=participants with available data for this endpoint.||percentage of participants|||Number
666785|NCT01751308|Primary|Phase 1: Maximum Tolerated Dose of Cabazitaxel|MTD was highest dose level of cabazitaxel at which no more than 1 of 6 evaluable participants experienced dose limiting toxicities (DLT). DLT defined as an AE or abnormal laboratory values related to study treatment: hematologic DLTs: any Grade(G)4 hematologic toxicity except neutropenia G4 lasting≤7 days,G3 or 4 febrile neutropenia except G3 or 4 febrile neutropenia in absence of granulocyte-colony stimulating factor prophylaxis, G4 thrombocytopenia; non-hematologic DLTs:any G≥3 non-hematologic toxicity except G3 nausea or G3 or4 vomiting, G3 or4 diarrhea,G3 or4 dehydration,G3 fatigue lasting≤7 days, inadequately treated hypersensitivity reactions, elevated transaminases<10* upper limit of normal of ≤7 days, re-treatment delay of>2 weeks due to delayed recovery from toxicity related to study treatment to baseline G or≤ G1(except for alopecia) and platelet transfusion during Cycle1. Grades based on National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.|Cycle 1 (21 days)|DLT evaluable population defined as a subset of participants in the Phase 1 part of the study from the AT population who received the first dose of cabazitaxel and had sufficient safety evaluations or experienced a DLT during Cycle 1.||mg/m^2|||Number
666786|NCT01751178|Secondary|Turesky Modification of Quigley & Hein Plaque Index for Interproximal Plaque Scores|Interproximal plaque scores were analyzed on the mesiofacial, distofacial, mesiolingual and distolingual surfaces, and calculated taking the average over all tooth sites for a participant. The scores could range from 0-5 (0=No plaque; 1=Slight flecks of plaque at the cervical margin of the tooth; 2= A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth; 3=A band of plaque wider than 1 mm but covering less than 1/3 of the area to be graded of the crown of the tooth; 4=Plaque covering at least 1/3 but less than 2/3 of the area to be graded of the crown of the tooth; 5=Plaque covering 2/3 or more of the area to be graded of the crown of the tooth)|Change from baseline to 6 weeks|This analysis was conducted on ITT population, defined as those subjects who received study treatment and had at least one post-baseline efficacy measurement.||Units on a scale||Standard Error|Mean
666787|NCT01751178|Secondary|Turesky Modification of Quigley & Hein Plaque Index for Overall Plaque Scores|Overall plaque scores were calculated taking the average over all tooth sites for a participant. The scores could range from 0-5 (0=No plaque; 1=Slight flecks of plaque at the cervical margin of the tooth; 2= A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth; 3=A band of plaque wider than 1 mm but covering less than 1/3 of the area to be graded of the crown of the tooth; 4=Plaque covering at least 1/3 but less than 2/3 of the area to be graded of the crown of the tooth; 5=Plaque covering 2/3 or more of the area to be graded of the crown of the tooth)|Change from baseline to 6 weeks|This analysis was conducted on the Intent-to-Treat (ITT) population, defined as those subjects who received study treatment and had at least one post-baseline efficacy measurement.||Units on a scale||Standard Error|Mean
666788|NCT01751178|Secondary|Gingival Index|The GI was assessed on the facial and lingual surfaces at six sites on each tooth (facial and lingual - distal papillae, margin and mesial papillae). These assessments were performed on all evaluable teeth using moderate pressure sweeping a blunt ended probe, which was engaged in approximately 1 millimetre (mm) into the gingival crevice. The scores could range from 0-3 (0=Absence of inflammation; 1=Mild Inflammation-Slight change in color slight change in texture, no bleeding on probing; 2=Moderate Inflammation -glazing, redness edema and hypertrophy, bleeding on probing; 3= Severe inflammation-marked redness and hypertrophy, tendency for spontaneous bleeding)|Change from baseline to 6 weeks|This analysis was conducted on the Intent-to-Treat (ITT) population, defined as those subjects who received study treatment and had at least one post-baseline efficacy measurement.||Units on a scale||Standard Error|Mean
666789|NCT01751178|Primary|Gingival Severity Index (GSI) Based on the Gingival Index (GI)|"Measure of gingival severity averaged across whole mouth site; each site scored 0, 1, 2, 3 based on GI and,
GSI = 0 if GI is 0 or 1 (no bleeding)
GSI = 1 if GI is 1 or 2 (bleeding)"|Change from baseline to 6 weeks|This analysis was conducted on the Intent-to-Treat (ITT) population, defined as those subjects who received study treatment and had at least one post-baseline efficacy measurement.||Units on a scale||Standard Error|Mean
666790|NCT01751165|Secondary|Number of Subjects With pIMDs.|pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|From one month (30 Days) following the last vaccine administration up to study end at Month 24|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.||Subjects|||Number
666791|NCT01751165|Secondary|Number of Subjects With Potential Immune-mediated Diseases (pIMDs).|pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|From Dose 1 up to one month (30 days) following the last vaccine dose administration (Dose 2)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.||Subjects|||Number
666792|NCT01751165|Secondary|Number of Days With Solicited General Symptoms.|Each dose was abbreviated as follows: D1 = Dose 1, D2 = Dose 2.|During the 7 Days (Day 0-6) following vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.||Days|||Number
666793|NCT01751165|Secondary|Number of Days With Solicited Local Symptoms.|Each dose was abbreviated as follows: D1 = Dose 1, D2 = Dose 2.|During the 7 Days (Day 0-6) following vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.||Days|||Number
667436|NCT01740089|Secondary|Number of Randomized Patients Achieving Sustained Virologic Response (SVR) – Negative PCR Result for HCV RNA (< 15 IU/ml) 24 Weeks After Last Dose of Study Treatment.||24 weeks after last dose of study treatment|||participants|||Number
666794|NCT01751165|Secondary|Number of Subjects With SAE(s).|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity.|Starting from 30 Days post last vaccine administration up to study end at Month 24|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.||Subjects|||Number
666795|NCT01751165|Secondary|Number of Subjects With Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity.|From first vaccination up to one month (30 Days) post last vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.||Subjects|||Number
666796|NCT01751165|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs).|An adverse event (AE) is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|During the 30 Days (Day 0-29) following vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.||Subjects|||Number
666797|NCT01751165|Secondary|Number of Subjects With Solicited General Symptoms.|"Assessed solicited general symptoms were Fatigue, Gastrointestinal (meaning nausea, vomiting, diarrhoea and/or abdominal pain), Headache, Myalgia, Shivering and Temperature (temperature higher than [≥] 37.5 degrees Celsius [°C]). Any = occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Related = occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Fatigue = fatigue that prevented normal activity. Grade 3 Gastrointestinal = gastrointestinal that prevented normal every day activities. Grade 3 Headache = headache that prevented normal activity. Grade 3 Myalgia = myalgia that prevented normal activity. Grade 3 Shivering = shivering that prevented normal activity. Grade 3 Temperature = temperature higher than (>) 39.0°C."|During the 7 day period (Days 0-6) following each dose (D)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.||Subjects|||Number
666798|NCT01751165|Secondary|Number of Subjects With Solicited Local Symptoms.|"Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (>) 100 millimeters (mm). “Any” is defined as incidence of the specified symptom regardless of intensity."|During the 7 day period (Days 0-6) following each dose (D)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.||Subjects|||Number
666799|NCT01751165|Secondary|Concentrations of Antibodies Against Anti-gE as Determined by ELISA.||Prior (PRE) to vaccination and twelve (M12) post Dose 2|The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects for whom the pre vaccination and one month post dose 2 time point data were obtained from ATP cohort for immunogenicity.||mIU/mL||95% Confidence Interval|Geometric Mean
666800|NCT01751165|Primary|Concentrations of Antibodies Against Anti-gE as Determined by ELISA.||At one month (M1) after Dose 2|The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects for whom the pre vaccination and one month post dose 2 time point data were obtained from ATP cohort for immunogenicity.||mIU/mL||95% Confidence Interval|Geometric Mean
666801|NCT01751165|Primary|Number of Subjects With Vaccine Response to Anti-glycoprotein E (Anti-gE) Antibodies as Determined by the Enzyme-linked Immunosorbent Assay (ELISA).|"Vaccine response was defined as: for initially seronegative subjects, antibody concentration at post-vaccination ≥ 4 fold the cut-off for Anti-gE (4x97 mIU/mL); for initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration.
The objective required a comparison of VRR between 0,6-months and 0,12-months schedules."|At one month (M1) after Dose 2|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all subjects who had met all eligibility criteria and for whom data concerning immunogenicity outcome measures were available.||Subjects|||Number
666802|NCT01751113|Secondary|Use of Rescue Medication (Number of Occasions Per 24-hour Period) as Recorded in the Daily Record Card at Day 28 of Each Treatment Period|Participants were given daily record cards for daily completion during the run-in, washout and treatment periods. Each morning, participants recorded the number of occasions in the last 24 hours when they had used their rescue medication (salbutamol) for symptomatic relief of COPD symptoms.|Day 28 of each treatment period (up to 35 days)|mITT Population. Only those participants available who used rescue medication at the specified periods were analyzed (represented by n=X, X, X in the category titles).||Number of occasions||Standard Deviation|Mean
666803|NCT01751113|Secondary|Post-dose FEV1/FVC Ratio (Measured at Trough) at Day 28 of Each Treatment Period|FEV1 is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FVC is defined as the amount of air that can forcibly be blown out after a full inspiration. FEV1 and FVC data was obtained by spirometry measurements.|Day 28 of each treatment period (up to 35 days)|mITT Population||Ratio of FEV1/FVC||Standard Error|Least Squares Mean
666804|NCT01751113|Secondary|Post-dose FEV1, FVC, IC, RV, TLC and TGV (Measured at Trough) at Day 28 of Each Treatment Period|FEV1 is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FVC is defined as the amount of air that can forcibly be blown out after a full inspiration. FEV1 and FVC data was obtained by spirometry measurements. IC is defined as the maximum amount of air that can be inhaled into the lungs from the normal resting position after breathing out normally. Total lung capacity (TLC) is the maximum volume to which the lungs can be expanded with the greatest possible inspiratory effort; it is equal to the vital capacity (VC) plus the RV. RV is defined as the volume of air remaining in the lungs after a maximal exhalation. Thoracic gas volume at functional residual capacity (TGV) is defined as the volume of intrathoracic gas at the time the airway is occluded for the plethysmographic measurement at the end of a normal expiration.|Day 28 of each treatment period (up to 35 days)|mITT Population||Liters (L)||Standard Error|Least Squares Mean
666818|NCT01751087|Secondary|Need for Mechanical Dilation|Assessed on Day of procedure. Assessed immediately after completion of D&E|participants were assessed for the duration of the procedure, an average of 6 minutes|Arm 1: one subject withdrawn/no intervention. Arm 2: one subject expelled, no D&E. Arm 3: one subject withdrawn/no intervention||participants||95% Confidence Interval|Number
666805|NCT01751113|Secondary|Trough sGaw Measured at Each Clinic Visit Prior to the Morning Dose and Before the Use of Rescue Medication at Day 28 of Each Treatment Period|sGaw is a measure of airways conductance and is intimately related to the diameter of the airways and consequently the level of bronchodilation. Trough values were the values taken pre-dose.|Day 28 of each treatment period (up to 35 days)|mITT Population||1/kPa*s||Standard Error|Geometric Mean
666806|NCT01751113|Secondary|Trough sRaw Measured at Each Clinic Visit Prior to the Morning Dose and Before the Use of Rescue Medication at Day 28 of Each Treatment Period|sRaw is a measure of airways resistance and is intimately related to the diameter of the airways and consequently the level of bronchodilation. Trough values were the values taken pre-dose.|Day 28 of each treatment period (up to 35 days)|mITT Population||kPa*s||Standard Error|Geometric Mean
666807|NCT01751113|Secondary|Trough FEV1/FVC Ratio, at Each Clinic Visit Prior to the Morning Dose and Before the Use of Rescue Medication at Day 28 of Each Treatment Period|FEV1 is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FVC is defined as the amount of air that can forcibly be blown out after a full inspiration. FEV1 and FVC data was obtained by spirometry measurements. Trough values were the values taken pre-dose.|Day 28 of each treatment period (up to 35 days)|mITT Population||Ratio of FEV1/FVC||Standard Error|Least Squares Mean
666808|NCT01751113|Secondary|Trough Forced Expiratory Volume in One Second (FEV1), Forced Vital Capacity (FVC), Inspiratory Capacity (IC), RV, TLC, and TGV at Each Clinic Visit Prior to the Morning Dose and Before the Use of Rescue Medication at Day 28 of Each Treatment Period|FEV1 is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FVC is defined as the amount of air that can forcibly be blown out after a full inspiration. FEV1 and FVC data was obtained by spirometry measurements. IC is defined as the maximum amount of air that can be inhaled into the lungs from the normal resting position after breathing out normally. Total lung capacity (TLC) is the maximum volume to which the lungs can be expanded with the greatest possible inspiratory effort; it is equal to the vital capacity (VC) plus the residual volume (RV). RV is defined as the volume of air remaining in the lungs. after a maximal exhalation. Thoracic gas volume at functional residual capacity (TGV) is defined as the volume of intrathoracic gas at the time the airway is occluded for the plethysmographic measurement at the end of a normal expiration. Trough values were the values taken pre-dose.|Day 28 of each treatment period (up to 35 days)|mITT Population||Liters (L)||Standard Error|Least Squares Mean
666809|NCT01751113|Secondary|Post-dose sRaw at 30, 75, 120 and 240 Minutes Post Dose at Day 28 of Each Treatment Period|sRaw is a measure of airways resistance and is intimately related to the diameter of the airways and consequently the level of bronchodilation. Plethysmography was performed to assess sRaw. A natural logarithmic transformation was applied and the data was analysed by a mixed model including treatment, time, period, a treatment by time interaction and Baseline sRaw fitted as fixed effects and participant fitted as a random effect.|Day 28 of each treatment period (up to 35 days)|mITT Population||kPa*s||Standard Error|Geometric Mean
666810|NCT01751113|Secondary|Post-dose sGaw at 30, 75, 120 and 240 Minutes Post Dose at Day 28 of Each Treatment Period|sGaw is a measure of airways conductance and is intimately related to the diameter of the airways and consequently the level of bronchodilation. Plethysmography was performed to assess sGaws. A natural logarithmic transformation was applied and the data was analyzed by a mixed model including treatment, time, period, a treatment by time interaction and Baseline sGaw fitted as fixed effects and participant fitted as a random effect.|Day 28 of each treatment period (up to 35 days)|mITT Population||1/kPa*s||Standard Error|Geometric Mean
666811|NCT01751113|Secondary|AUC (0-4hr) Specific Airway Resistance (sRaw) After the Morning Dose of Each Study Medication at Day 28 of Each Treatment Period|sRaw is a measure of airways resistance and is intimately related to the diameter of the airways and consequently the level of bronchodilation. Plethysmography was performed to assess sRaw. The AUC was determined by using the trapezoidal rule and then dividing by the relevant time interval. A natural logarithmic transformation was applied and the data was analyzed by a mixed model including treatment, period and Baseline sRaw fitted as fixed effects and participants fitted as a random effect. Treatment ratios of all statistical comparisons were calculated by taking the anti-log of the difference between the LS means.|Day 28 of each treatment period (up to 35 days)|mITT Population||kPa*s||Standard Error|Geometric Mean
666812|NCT01751113|Primary|Area Under the Curve Calculated From 0 to 4 Hours (AUC[0-4hr]) Specific Conductance (sGaw) After the Morning Dose of Study Medication at Day 28 of Each Treatment Period|sGaw is a measure of airways conductance and is intimately related to the diameter of the airways and consequently the level of bronchodilation. Plethysmography was performed to assess sGaw. The AUC was determined by using the trapezoidal rule and then dividing by the relevant time interval. A natural logarithmic transformation was applied and the data was analyzed by a mixed model including treatment, period and Baseline sGaw fitted as fixed effects and participants fitted as a random effect. Treatment ratios of all statistical comparisons were calculated by taking the anti-log of the difference between the Least Square (LS) means.|Day 28 of each treatment period (up to 35 days)|Modified Intent-to-Treat (mITT) Population: all randomized participants who received at least one dose of study medication and completed at least two treatment periods and also had a Baseline and at least one on treatment sGaw assessment measure.||1/kilopascal*second (1/kPa*s)||Standard Error|Geometric Mean
666813|NCT01751087|Secondary|Physician Satisfaction With Cervical Preparation|Participants for whom the operating physician reported being satisfied or very satisfied with the cervical preparation. Assessed on Day of procedure. Assessed after completion of D&E procedure.|physicians' satisfaction with cervical prep was evaluated over course of procedure, an average of 6 minutes|"Data on whether the physician was satisfied with the cervical preparation is available for all participants except:
Arm 1: 1 participant withdrawn with no intervention; Arm 2: 1 participant who didn't have a D&E (expelled), Arm 3: 1 participant withdrawn with no intervention and one with missing data."||participants||95% Confidence Interval|Number
666814|NCT01751087|Secondary|Patient Satisfaction With Cervical Prep|Patients who were very satisfied or satisfied with cervical preparation. Assessed on Day of procedure. Assessed after completion of D&E procedure and just prior to discharge home.|patients' satisfaction with cervical prep was evaluated over course of cervical prep and procedure, up to 3 days|||participants|||Number
666815|NCT01751087|Secondary|Chills (Any) After Day 2 Medication Administration|chills (any) after Day 2 medication administration|assessed immediately after administration of day 2 medication|||participants||95% Confidence Interval|Number
666819|NCT01751087|Secondary|Ability to Complete the D&E on the First Attempt|Assessed on day of procedure and following day. If the procedure was unable to be completed as planned and the subject had to leave the procedure room and return for another attempt either at a time later the same day or the next day.|participants were assessed for the duration of the procedure, an average of 6 minutes|||participants|||Number
666820|NCT01751087|Secondary|Initial Cervical Dilation|Measured at the time of procedure (immediately before the start of D&E)|participants were assessed during cervical dilation process, average time of 1 minute|Arm 1: 1 subject excluded [withdrawn/no intervention]. Arm 2: 2 excluded: [one expelled, no D&E, one D&E not completed on first attempt & data missing]. Arm 3: 2 excluded (1 withdrawn/no intervention, 1 D&E not completed on first attempt & data missing]. Additionally missing data for one more subject in Arm 2.||centimeters||Standard Deviation|Mean
666821|NCT01751087|Primary|Operative Time|The duration of the D&E procedure was measured with a stopwatch, starting with the first instrument that passes into the uterus and ending when the last instrument is removed from the uterus upon completion of the D&E|participants were assessed for the duration of the procedure, an average of 6 minutes|Arm 1 (dilators-alone): 1 subject excluded [withdrawn/no intervention]. Arm 2 (dilators + misoprostol): 2 excluded: [one expelled, no D&E, one D&E not completed on first attempt & data missing]. Arm 3 (dilators + mifepristone): 2 excluded (1 withdrawn/no intervention, 1 D&E not completed on first attempt & data missing].||minutes||Standard Deviation|Mean
666822|NCT01751022|Secondary|Complication Rate for Individual Attain Performa Lead Related Events||6 month post-Implant|Subjects with Attain Performa LV Lead Model successfully implanted. Results for model 4298 comes from its PMA-S Clinical Report Version 1, 27MAR2014; for model 4398 comes from its PMA-S Clinical Report Version 3, 03SEP2014; for model 4598 comes from its PMA-S Clinical Report Version 1, 29AUG2014.||percentage of participants||95% Confidence Interval|Number
666823|NCT01751022|Secondary|Pacing Impedance at the Final Programmed Pacing Polarity|"Pacing impedance for each LV pacing polarity. Noticed that pacing impedance values are not recorded for reversed LV pacing polarities, since impedance from LV1 to LV2 is the same as from LV2 to LV1.
Impedance is a measurement of current/resistance between the pacing lead and the cardiac tissue (measured in Ohms)."|6 month post-implant|Subjects with Attain Performa LV lead implanted and complete Medtronic Quad CRT-D system and valid measures of lead impedance at 6-month visit. Results for model 4298 comes from its PMA-S Clinical Report V1, 27MAR14; for model 4398 comes from its PMA-S Clinical Report V3, 03SEP14; for model 4598 comes from its PMA-S Clinical Report V1, 29AUG14.||Ohms||Standard Deviation|Mean
666824|NCT01751022|Secondary|Implant Related Times Per Attain Performa Lead Model||Implant up to 1-month post implant|Subjects with Attain Performa LV Lead Model successfully implanted. Results for model 4298 comes from its PMA-S Clinical Report Version 1, 27MAR2014; for model 4398 comes from its PMA-S Clinical Report Version 3, 03SEP2014; for model 4598 comes from its PMA-S Clinical Report Version 1, 29AUG2014.||minutes||Standard Deviation|Mean
666825|NCT01751022|Secondary|Pacing Capture Thresholds at the Final Programmed Pacing Polarity||6 months post-implant|Subjects with Attain Performa LV Lead Model implanted and valid pacing thresholds measured at the 6 month follow-up visit. Results for model 4298 comes from its PMA-S Clinical Report Version 1, 27MAR2014; for model 4398 comes from its PMA-S Clinical Report Version 3, 03SEP2014; for model 4598 comes from its PMA-S Clinical Report V. 1, 29AUG2014.||Volts||Standard Deviation|Mean
666826|NCT01751022|Secondary|Rate of Overall Acceptable Lead Handling Per Attain Performa Lead Model||Implant up to 1-month post implant|Subjects with an attempted Attain Performa LV Lead Model. Results for lead model 4298 comes from its PMA-S Clinical Report Version 1, 27MAR2014; results for lead model 4398 comes from its PMA-S Clinical Report Version 3, 03SEP2014; results for lead model 4598 comes from its PMA-S Clinical Report Version 1, 29AUG2014.||percentage of participants|||Number
666827|NCT01751022|Secondary|Percentage of Subjects With Successful Implant Per Attain Performa Lead Model||Implant up to 1-month post implant|Subjects with an attempted Attain Performa LV Lead Model. Results for lead model 4298 comes from its PMA-S Clinical Report Version 1, 27MAR2014; results for lead model 4398 comes from its PMA-S Clinical Report Version 3, 03SEP2014; results for lead model 4598 comes from its PMA-S Clinical Report Version 1, 29AUG2014.||percentage of participants||95% Confidence Interval|Number
666828|NCT01751022|Secondary|Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities|Percentage of patients with presence of PNS in all LV lead pacing polarities at 8.0 V at 0.5ms performed at 6-month visit.|6 months post-implant|Subjects with Attain Performa LV Lead implanted and at least 1 valid pacing threshold at any LV lead pacing polarity measured at the 6 month visit. Results for model 4298 comes from its PMA-S Clinical Report V1, 27MAR14; for model 4398 comes from its PMA-S Clinical Report V3, 03SEP14; for model 4598 comes from its PMA-S Clinical Report V1, 29AUG14.||percentage of participants|||Number
666829|NCT01751022|Primary|LV Pacing Capture Thresholds Per Attain Performa Lead Model||6 months post-implant|Subjects with Attain Performa LV Lead Model implanted and valid pacing thresholds measured at the 6 month follow-up visit. Results for model 4298 comes from its PMA-S Clinical Report Version 1, 27MAR2014; for model 4398 comes from its PMA-S Clinical Report Version 3, 03SEP2014; for model 4598 comes from its PMA-S Clinical Report V. 1, 29AUG2014.||percentage of participants||97.5% Confidence Interval|Mean
666830|NCT01751022|Primary|Lead Complication-free Rate at 6 Months|"The three Attain Performa LV leads models are evaluated separately. The primary safety objective is listed as following:
- Model 4298/4398: The Attain Performa Model 4298/4398 lead will be considered safe if the probability of subjects freed of Attain Performa lead-related complications at 6 months post-implant is greater than 87% (i.e., the one-sided 97.5% lower confidence bound must be greater than 87%).
- Model 4598: The safety performance of the Attain Performa Model 4598 lead will be characterized by summarizing the probability of subjects who are free from Attain Performa LV lead related complications at 6 months.
The lower boundaries of the 97.5% confidence intervals for the all lead models are greater than the pacing threshold of 87%, thus concluding that the crtiera was met for all lead models."|Implant to 6 months post-implant|Subjects with an attempted Attain Performa LV Lead Model. Results for lead model 4298 comes from its PMA-S Clinical Report Version 1, 27MAR2014; results for lead model 4398 comes from its PMA-S Clinical Report Version 3, 03SEP2014; results for lead model 4598 comes from its PMA-S Clinical Report Version 1, 29AUG2014.||Survival Probability (%)||97.5% Confidence Interval|Number
666868|NCT01750255|Secondary|Adherence to Treatment|Total percentage of adherence by treatment group|1 year|Total percentage of adherence by treatment group||Medication adherence percentage|||Number
666831|NCT01750931|Secondary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product and can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, is medically important event or reaction, is associated with liver injury Alanine amino transferase (more than equal to [>=] 3 fold upper normal of limit [ULN]) or total bilirubin (>=2 fold ULN) or international normalization ratio more than 1.5. Refer to the general AE/SAE module for a list of AEs and SAEs.|Up to 20 days|All subject population.||Participants|||Number
666832|NCT01750931|Primary|Elimination Half Life (T-half) After a Single Dose|The T-half was calculated using the following formula by dividing 0.693 (natural logarithm of 2) with lambda z, where lambda z is the terminal phase rate constant estimated by linear regression analysis of the log transformed concentration-time data after each single dose.|Pre-dose (two samples collected within a period of 1 hour) and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 9.0, 10.0, 12.0, 16.0, 24.0, 48.0, 72.0 and 96.0 hours post-dose in each treatment period|All subject population. All participants were present at the time of measurement.||Per hour||Full Range|Median
666833|NCT01750931|Primary|Elimination Rate Constant (Kel) After a Single Dose|Plasma samples for PK analysis were drawn at indicated time points of each treatment period. The apparent first-order elimination or terminal rate constant was calculated from a semilogarithmic plot of the plasma concentration versus time. The parameter was calculated by linear least-square regression analysis using the last three (or more) non-zero plasma concentrations.|Pre-dose (two samples collected within a period of 1 hour) and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 9.0, 10.0, 12.0, 16.0, 24.0, 48.0, 72.0 and 96.0 hours post-dose in each treatment period|All subject population. All participants were present at the time of measurement.||Per hour||Geometric Coefficient of Variation|Geometric Mean
666834|NCT01750931|Primary|The Percentage of Area Under Curve Extrapolated to Arrive at AUC0-infinity (AUCpercentage [%]_Extrap [Residual Area]) After a Single Dose|Plasma samples for PK analysis were drawn at indicated time points of each treatment period. The percentage of area under curve extrapolated to arrive at AUC0-infinity (AUC%_Extrap [residual area]) was determined by AUC0-infinity minus AUC0-t divided by AUC0-infinity multiplied by 100.|Pre-dose (two samples collected within a period of 1 hour) and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 9.0, 10.0, 12.0, 16.0, 24.0, 48.0, 72.0 and 96.0 hours post-dose in each treatment period|All subject population. All participants were present at the time of measurement.||Percentage of AUC Extrapolated||Geometric Coefficient of Variation|Geometric Mean
666835|NCT01750931|Primary|The Area Under the Plasma Concentration Versus Time Curve (AUC) After a Single Dose|Plasma samples for PK analysis were drawn at indicated time points of each treatment period. AUC(0-t) was area under the plasma concentration-time curve from time of administration until the time of last quantifiable concentration. The area under the plasma concentration-time curve (AUC0-infinity), was estimated by linear trapezoidal rule and was sum of the AUC0-t and extrapolated to infinity by dividing the estimated last measurable plasma concentration by elimination rate constant lambda z. Where lambda z is the terminal phase rate constant estimated by linear regression analysis of the log transformed concentration-time data after each single dose. The AUC0-infinity was the sum of the estimated and extrapolated parts.|Pre-dose (two samples collected within a period of 1 hour) and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 9.0, 10.0, 12.0, 16.0, 24.0, 48.0, 72.0 and 96.0 hours post-dose in each treatment period|All subject population. All participants were present at the time of measurement.||Nanogram.hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
666836|NCT01750931|Primary|Time to Maximum Concentration (T-max)|Plasma samples for PK analysis were drawn at indicated time points of each treatment period. The Tmax was taken directly from the plasma concentration-time profile of individual participants. Plasma samples for PK analysis were drawn at indicated time points.|Pre-dose (two samples collected within a period of 1 hour) and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 9.0, 10.0, 12.0, 16.0, 24.0, 48.0, 72.0 and 96.0 hours post-dose in each treatment period|All subject population||Hour||Full Range|Median
666837|NCT01750931|Primary|Maximum Drug Concentration During the Selected Dosing Interval (Cmax) After a Single Dose|Plasma samples for pharmacokinetic (PK) analysis were drawn at indicated time points of each treatment period. The Cmax was taken directly from the plasma concentration-time profile of individual participants|Pre-dose (two samples collected within a period of 1 hour) and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 9.0, 10.0, 12.0, 16.0, 24.0, 48.0, 72.0 and 96.0 hours post-dose in each treatment period|All subject population: all participants who complete all periods of the study. All participants were present at the time of measurement.||Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
666838|NCT01750840|Secondary|Quality of Life Assessment|Quality of life was intended to be measured by 5 scoring systems that ask a range of questions about the patient's pain and function. No quality of life data was captured for any of the patients and as such no quality of life analysis was performed.|The quality of life assessment was to be completed at the regular doctor's visit at which the physician determined the patient to be healed. No quality of life data was collected.|No quality of life data was collected for any of the patients enrolled in the study. As such, no analysis was performed on quality of life measures.|||||
666839|NCT01750840|Primary|Radiographic Assessment of Healing|Bone healing was assessed on x-rays and/or CT scan.|The time frame for healing determination was not pre-specified. Patients were evaluated at regular doctors' visits for up to 12 months. The physician determined the time point at which healing occurred for each patient at their regular visits.|All patients, with one nonunion fracture each, were treated with the Biomet EBI Bone Healing System. Four patients had final healing outcomes reported (two patients with a 5th metatarsal nonunion, one patient with a tibial nonunion and one patient with a fibula nonunion) and all healed in an average time of 2.5 months.||percentage of healed fractures|Fractures||Number
666906|NCT01748942|Secondary|Length of Hospital Stay (Number of Days Between the Date of Surgery and Date of Discharge)|Kaplan-Meier functions will be fitted to compare the length of hospital stay between the experimental and control groups.|Up to 21 days|||days||Standard Deviation|Median
666840|NCT01750684|Secondary|Pharmacokinetic (PK) Parameters of AC105 Using Individual Patient Plasma Concentration-time Data|Measuring Maximum Measured Plasma Concentration (Cmax), Time to Maximum Measured Plasma Concentration (Tmax), Half-life calculated as In(2)/kel (T 1/2) and Area Under the Plasma Concentration versus time curve (AUC).|baseline, prior to and up to 5 hours following last infusion||||||
666841|NCT01750684|Primary|Safety and Tolerability Assessed by Comparing Adverse Event (AE) Data for Patients Administered a Regimen of 6 Intravenous Doses of AC105 Over 30 Hours Compared With Patients Administered the Same Regimen of Placebo.|Treatment-Emergent Adverse Events (TEAEs) are defined as AEs with date time of onset (or worsening) on or after the start date time of the first infusion and no more than 30 days after the end of the last infusion.|up to 6 months|Safety Population||participants|||Number
666842|NCT01750502|Other Pre-specified|Comparison of MIF-173G/C Alleles of CHD Patients and Controls.||Before surgery|All participants drawn from hospital inpatient cardiovascular medicine between June 2012-January 2013.This analysis was per protocol, but not intention to treat.Because the number of CHD group is less than the normal group during hospitalization.||alleles|||Number
666843|NCT01750502|Other Pre-specified|Comparison With MIF-173G/C Genotypes of CHD Patients and Controls.||Before surgery|||participants|||Number
666844|NCT01750502|Secondary|Comparison the Change of MIF Before and After Percutaneous Coronary Intervention （PCI） at the Patients Who Are Acute Coronary Syndromes and Stable Ischemic Heart Disease|Percutaneous Coronary Intervention are extracted 3 times including before surgery 5 minutes , 5 minutes after the opening of the balloon and after surgery 5 minutes ,and detection MIF concentration .|3 times including before surgery 5 minutes, 5 minutes after the opening of the balloon and after surgery 5 minutes|Coronary-artery-disease Group does not include myocardial infarction, 21 patients were acute myocardial infarction participants.||MIF Concentration , ug/L||Standard Deviation|Mean
666845|NCT01750502|Primary|Comparison Between Coronary-artery-disease Group and Non-coronary-artery-disease Group on MIF Concentration|Participants will be extracted 3ml blood before surgery 5 minutes,detection MIF concentration on two groups.We hypothesis that the experimental group will be higher than control group.|Before surgery 5 minutes|All participants drawn from hospital inpatient cardiovascular medicine between June 2012-January 2013.This analysis was per protocol, but not intention to treat.Because the number of CHD group is less than the normal group during hospitalization.||MIF Concentration,ug/L||Standard Deviation|Median
666846|NCT01750398|Secondary|Change in Waist Circumference||Bseline, 6 months and 9 months.|||cm||Standard Deviation|Mean
666847|NCT01750398|Secondary|Change in Weight|Change in weight is measured from baseline to 6 months (i.e. following ADT lead in) and from 6 months to 9 months (i.e. from post-ADT to the end of cycle 1 of BAT).|Baseline, 6 months and 9 months.|||kg||Standard Deviation|Mean
666848|NCT01750398|Secondary|Quality of Life Survey|"To measure quality of life through the RAND-SF36 (short-form 36 questionnaire) Quality of Life Survey, the Functional Assessment of Cancer Therapy - Prostate Cancer (FACT-P), the International Index of Erectile Function (IIEF), the International Prostate Symptom Score (IPSS) and a visual pain scale. Note that for all scales, higher scores indicate better quality of life/function, with the exception being the visual pain scale, where a higher score indicates more pain.
RAND-SF36: SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. Range is from 0 to 100.
FACT-P: A tool used for assessing the health-related quality of life in men with prostate cancer. Range is from 0 to 156.
IIEF: Is a measure of erectile function. Range is from 5 to 25. IPSS: A tool used to measure symptoms related to prostatic disease. Range is from 0 to 35.
Visual pain scale: A tool used to track pain level. Range is from 0 to 10."|3 months|||units on a scale||Full Range|Median
666849|NCT01750398|Secondary|Change in C-telopeptides|Change in c-telopeptides following Round 1 of BAT (9 months) compared to the timepoint immediately following the ADT Lead-In (6 months)|6 months and 9 months|||pg/ml||Standard Deviation|Mean
666850|NCT01750398|Secondary|Complete PSA Response|To evaluate the number of patients who achieve a complete PSA response (i.e. serum PSA <0.2 ng/ml) at the end of the study|18 months|||participants|||Number
666851|NCT01750398|Secondary|Radiographic or Clinical Progression|To evaluate the number of men treated per the bipolar androgen therapy phase of the trial who developed radiographic or clinical progression. Radiographic progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Clinical progression was defined as new symptoms that can be attributed to progressive prostate cancer (e.g. new/worsening pain, urinary obstruction, cord compression, bone fractures).|18 months|||participants|||Number
666852|NCT01750398|Primary|Patients With PSA <4 ng/mL at the End of the Study|To determine the clinical effects of BAT in men with recurrent prostate cancer as first line therapy. This will be accomplished by assessing the number of patients achieving a PSA <4 ng/ml at the end of the trial.|18 months|||participants||90% Confidence Interval|Number
666853|NCT01750346|Secondary|The Jankovic Blepharospasm Rating Scale at 7 Months|"The Jankovic Blepharospasm Rating Scale (JBRS) was measured at 7 months from the start of the study drug or placebo. The JBRS is a clinical scale measuring the severity and frequency of blepharospasm. Severity and frequency are rated on a 5-point scales ranging from 0 to 4, where 0 indicates no symptoms and 4 indicates the most severe or frequent symptoms (Severity: severe, incapacitating spasm of eyelids and possibly other facial muscles; Frequency: Functionally blind due to persistent eye closure (blepharospasm) more than 50% of the waking time.) A total score is obtained by adding the severity and frequency subscale scores with total scores ranging from 0 to 8."|7 months|||units on a scale|||Number
666854|NCT01750346|Secondary|The Jankovic Blepharospasm Rating Scale at 6 Months|"The Jankovic Blepharospasm Rating Scale (JBRS) was measured at 6 months from the start of the study drug or placebo. The JBRS is a clinical scale measuring the severity and frequency of blepharospasm. Severity and frequency are rated on a 5-point scales ranging from 0 to 4, where 0 indicates no symptoms and 4 indicates the most severe or frequent symptoms (Severity: severe, incapacitating spasm of eyelids and possibly other facial muscles; Frequency: Functionally blind due to persistent eye closure (blepharospasm) more than 50% of the waking time.) A total score is obtained by adding the severity and frequency subscale scores with total scores ranging from 0 to 8."|6 months|||units on a scale|||Number
667437|NCT01740089|Secondary|Number of Randomized Patients Achieving Rapid Virologic Response (RVR) – Negative PCR Result for HCV RNA (< 15 IU/ml) After 4 Weeks of Treatment.||4 weeks|||participants|||Number
666855|NCT01750346|Secondary|The Jankovic Blepharospasm Rating Scale at 3 Months|"The Jankovic Blepharospasm Rating Scale (JBRS) was measured at 3 months from the start of the study drug or placebo. The JBRS is a clinical scale measuring the severity and frequency of blepharospasm. Severity and frequency are rated on a 5-point scales ranging from 0 to 4, where 0 indicates no symptoms and 4 indicates the most severe or frequent symptoms (Severity: severe, incapacitating spasm of eyelids and possibly other facial muscles; Frequency: Functionally blind due to persistent eye closure (blepharospasm) more than 50% of the waking time.) A total score is obtained by adding the severity and frequency subscale scores with total scores ranging from 0 to 8."|3 months|||units on a scale||Full Range|Mean
666856|NCT01750346|Secondary|The Blepharospasm Disability Scale at 2 Months|The Blepharospasm Disability Scale (BDS) was measured at 2 months from the start of the study drug or placebo. The BDS is a scale which measures the impact of blepharospasm on the activities of daily living, i.e., need to wear sunglasses (1 or 2) and the impact on the following activities: driving (1 to 5), reading (1 to 3), watching tv (1 to 3), watching movies (1 to 3), shopping (1 to 3), walking about (1 to 4) and housework or job (1 to 3). Patients self-report disability in all areas for a total score between 0 to 26, where 0 indicates no symptoms and 26 indicates severe disability.|2 months|||units on a scale||Full Range|Mean
666857|NCT01750346|Secondary|The Blepharospasm Disability Scale at 1 Month|The Blepharospasm Disability Scale (BDS) was measured at 1 month from the start of the study drug or placebo. The BDS is a scale which measures the impact of blepharospasm on the activities of daily living, i.e., need to wear sunglasses (1 or 2) and the impact on the following activities: driving (1 to 5), reading (1 to 3), watching tv (1 to 3), watching movies (1 to 3), shopping (1 to 3), walking about (1 to 4) and housework or job (1 to 3). Patients self-report disability in all areas for a total score between 0 to 26, where 0 indicates no symptoms and 26 indicates severe disability.|1 month|||units on a scale||Full Range|Mean
666858|NCT01750346|Secondary|The Jankovic Blepharospasm Rating Scale at 1 Month|"The Jankovic Blepharospasm Rating Scale (JBRS) was measured at 1 month from the start of the study drug or placebo. The JBRS is a clinical scale measuring the severity and frequency of blepharospasm. Severity and frequency are rated on a 5-point scales ranging from 0 to 4, where 0 indicates no symptoms and 4 indicates the most severe or frequent symptoms (Severity: severe, incapacitating spasm of eyelids and possibly other facial muscles; Frequency: Functionally blind due to persistent eye closure (blepharospasm) more than 50% of the waking time.) A total score is obtained by adding the severity and frequency subscale scores with total scores ranging from 0 to 8."|1 month|||units on a scale||Full Range|Mean
666859|NCT01750346|Primary|The Jankovic Blepharospasm Rating Scale at 2 Month|"The Jankovic Blepharospasm Rating Scale (JBRS) at 2 months from the start of the study drug or placebo. The JBRS is a clinical scale measuring the severity and frequency of blepharospasm. Severity and frequency are rated on a 5-point scales ranging from 0 to 4, where 0 indicates no symptoms and 4 indicates the most severe or frequent symptoms (Severity: severe, incapacitating spasm of eyelids and possibly other facial muscles; Frequency: Functionally blind due to persistent eye closure (blepharospasm) more than 50% of the waking time.) A total score is obtained by adding the severity and frequency subscale scores with total scores ranging from 0 to 8."|2 months|One participant in the 0.05% AH-8 arm was withdrawn due to development of blepharitis.||units on a scale||Full Range|Mean
666860|NCT01750294|Primary|Change of Systolic Ambulatory Blood Pressure From Baseline to 12 Weeks||Baseline and 12 weeks after intervention|Intention to treat analysis (includes completers and non-completers)||mmHg||Standard Deviation|Mean
666861|NCT01750281|Secondary|Overall Survival (OS)|The time from randomisation until death due to any cause. Any subject not known to have died at the time of analysis will be censored based on the last recorded date on which the subject was known to be alive|Following progression, survival status was collected every 8 weeks until death, withdrawal of consent, or end of study, whichever occurred first, up to 29 months (at the time of the analysis)|Full Analysis Set (All randomised patients)||Months||Inter-Quartile Range|Median
666862|NCT01750281|Primary|Progression Free Survival (PFS)|Median time from randomisation until the date of objective disease progression or death (by any cause in the absence of progression). Progression is defined using Response Evaluation Criteria in Solid Tumours (RECIST v1.1): >= 20% increase in the sum of diameters of Target Lesions (TL) and an absolute increase in sum of diameters of >=5mm (compared to the previous minimum sum) or progression of Non TLs or a new lesion.|Baseline and then every 6 weeks after randomization until objective disease progression, up to 29 months (at the time of the analysis)|Full Analysis Set (All randomised patients). Progression events that do not occur within 14 weeks of the last evaluable assessement are censored and therefore excluded.||Months||Inter-Quartile Range|Median
666863|NCT01750255|Secondary|Preventable Causes of Problems of Effectiveness and Safety of Pharmacotherapy|Quantify the preventable causes of problems of effectiveness and safety of pharmacotherapy. Quantify the process problems like a drug availability problems, problems in prescribing, dispensing problems, administration and use, quality problem.[Time Frame: At 3, 6, 9 and 12 months]|1 year||||||
666864|NCT01750255|Secondary|Necessity, Effectiveness and Security Problems Associated With Pharmacotherapy|Necessity problems of pharmacotherapy are related to the following two questions: 1) The patient has a health problem associated with not receiving a medication you need? 2) The patient has a health problem associated with getting a medicine that does not need. The safety of the pharmacotherapy will be measured by the safety profile of drugs and serum concentrations of drugs. The effectiveness of the pharmacotherapy will be measured by Hamilton Rating Scale for Depression, Clinical Global Impressions (CGI), Young Mania Rating Scale.|1 year||||||
666865|NCT01750255|Secondary|Depression|To assess depressive symptoms, will be used the the Hamilton Depression Rating Scale. [Time Frame: At 3, 6, 9 and 12 months]using hamilton depression scale|1 year||||||
666866|NCT01750255|Secondary|Mania||1 year||||||
666867|NCT01750255|Secondary|Clinical Global Impression for Bipolar Modified, CGI-BP-M.|The modified version of the Clinical Global Impression for Bipolar Disorder (CGI-BP-M) a condensed version of the CGI-BP, which is also an adaptation of the CGI for bipolar patients. The CGI-BP-M, is a scale for the assessment of manic, hypomanic, depressive or mixed symptoms, and long-term outcome of bipolar disorder. Assesses the current gravity, the short and long term of the disease course. It consists of three subscales, composed of a single item, evaluating the severity of the acute symptoms of depression, mania and disease in general (refers to the longitudinal disease severity). It has a Likert intensity scale of 7 degrees of freedom ( 1 normal, 7 very severe).|1 year|||Clinical Global Impression||Standard Deviation|Mean
666869|NCT01750255|Secondary|Quality of Life|The Short Form-36 Health Survey (SF-36): It is a questionnaire to measure quality of life, exploring the physical and mental health. Contains 36 topics that explore 8 dimensions of health: physical function; social function; limitations of the role: physical problems; limitations of the role: emotional problems; mental health; vitality; pain and general health perception. Each of the 8 dimensions of the SF-36 scores range between 0 and 100 values. 100 being a result indicating optimal health and 0 would reflect in a very bad state of health. The questionnaire allows the calculation of 2 scores summary, physical component summary (PCS) and mental (MCS), by combining each dimension scores|1 year|||Mental health summary score||Standard Deviation|Mean
666870|NCT01750255|Primary|To Reduce the Use of Health Care Services by Quantifying the Number of Unscheduled Outpatient Visits||1 year|||Outpatient-unscheduled visits|||Number
666871|NCT01750255|Primary|To Reduce the Use of Health Care Services by Quantifying the Number of Emergency Service Consultations||1 year|||Emergency Service Consultations|||Number
666872|NCT01750255|Primary|To Reduce the Use of Health Care Services by Quantifying the Number of Hospitalizations||1 year|||Hospitalizations|||Number
666873|NCT01750242|Secondary|Additional Study Measure on Unified Parkinson's Disease Rating Scale (UPDRS) III Scores|The summary of UPDRS III medication off score at baseline and the UPDRS III stimulation on/medication off score at follow-up and the change from baseline to 18 months. The UPRS III has a range of 0 - 108.|Change from baseline to 18 months|Per protocol||units on a scale||Standard Deviation|Mean
666874|NCT01750242|Primary|To Characterize the Percentage of Leads in Which the Target Map and the Clinically-derived Activation Map Overlap|The one-sided 95% exact binomial lower confidence bound of the proportion was calculated from subjects with readable images enrolled in the study.|18 months|Per Protocol||percentage of leads|Participants||Number
666875|NCT01750086|Primary|Bone Turnover Marker (Blood Sample)|The primary outcome was the between-group difference in the teriparatide-induced change in serum c-telopeptide from baseline to week 8.|8 weeks|||percentage of change in CTX||Standard Deviation|Mean
666876|NCT01749982|Primary|Change in Urinary % Dimethyl Arsenic||From baseline to 8 weeks after the start of the intervention (week 8 - baseline)|||percentage of total urinary arsenic||Full Range|Median
666877|NCT01749982|Primary|Change in Urinary % Inorganic Arsenic||From baseline to 8 weeks after the start of the intervention (week 8 - baseline)|||percentage of total urinary arsenic||Full Range|Median
666878|NCT01749982|Primary|Change in Urinary % Monomethyl Arsenic||From baseline to 8 weeks after the start of the intervention (week 8 - baseline)|||percentage of total urinary arsenic||Full Range|Median
666879|NCT01749956|Secondary|The Number of Participants Who Experienced Serious or Non-Serious Adverse Events as a Measure of Safety.|Adverse events and serious adverse events (AEs and SAEs) were graded according to National Cancer Institute Common Technology Criteria for Adverse Events (NCI CTCAE) v4.0. Specific AE and SAE terms are provided in the Adverse Event module.|weekly for 6 weeks pre-op then every 2 weeks post-op, approximately 36 weeks|All patients who received at least one dose of protocol treatment.||participants|||Number
666880|NCT01749956|Secondary|Disease Free Survival Probability at 6 and 12 Months|The probability of disease free survival at 6 and 12 months after initiating protocol treatment.|Up to 1 year|||probability||95% Confidence Interval|Number
666881|NCT01749956|Secondary|Disease-Free Survival||Patients without evidence of progression will be followed every 3 months (±1 month) from date of last dose of study drug during Years 1-2, every 6 months during Years 3-4, and annually thereafter or until disease progression, estimated 5 years.|All evaluable patients.||percentage of participants||95% Confidence Interval|Median
666882|NCT01749956|Secondary|Sphincter Preservation Rate|The percentage of patients who had Low Anterior Resection during surgery..|Between days 57 and 98 after preoperative chemotherapy.|||percentage of patients|||Number
666883|NCT01749956|Secondary|Overall Survival Probability at 6 and 12 Months|The probability of overall survival at 6 months and 12 months from date of first protocol treatment until date of death.|up to 1 year|||probability||95% Confidence Interval|Number
666884|NCT01749956|Secondary|Overall Survival|Measured from date of first protocol treatment until date of death.|Every 3 months (±1 month) following documented progression, up to 5 years or death, whichever comes first.|||participants||95% Confidence Interval|Median
666885|NCT01749956|Primary|Pathologic Complete Response Rate|The Pathologic Complete Response (pCR) Rate is defined as the number of pathologic complete responders among all patients evaluable for response, including evaluable patients who did not proceed to surgery. A pCR is defined as the absence of any residual abnormality detected in a pathological specimen.|Between days 57 and 98 after preoperative chemotherapy|All patients enrolled in the trial who were evaluable for pathologic response. Four patients were not evaluable for response.||participants|||Number
666886|NCT01749800|Primary|Sustained Attention to Response Task|Subjects are presented with objects (one at the time) on a computer screen and are instructed to press a key on the keyboard according to the characteristics of the object shown on the computer screen. Error rates are measured as percentage of erroneous key selections.|Baseline and end-of-treatment data (up to 2 weeks)|||percentage errors||Full Range|Mean
666887|NCT01749735|Primary|Change in Box and Block Test Score From Baseline|"The Box and Block Test is a functional test. Subjects are instructed to move small blocks from one box to a second box. The test measures the number of blocks that subjects can move during a period of 60 sec. The measurement unit for this task is the number of blocks. Subjects with no motor impairments would typically move about 60 to 80 blocks in a period of 60 sec."|Baseline, Day 5 (midpoint), Day 10 (endpoint), 1 wk post, 2 wks post, 4 wks post|||number of blocks||Standard Deviation|Mean
666888|NCT01749735|Primary|Change in Jebsen-Taylor Hand Function Test Score From Baseline|The Jebsen-Taylor Hand Function Test is a functional test consisting of 7 subtests. Each subtest requires that the subject performs a motor task (e.g. using one hand to pick up a small object positioned on a table in front of the subject). The test score is derived by measuring (using a stopwatch) the time in sec that the subject needs to complete the task. Individuals with no motor impairments typically need between 30 and 60 sec to complete the 7 subtests of the Jebsen-Taylor Hand Function Test.|Baseline, Day 5 (midpoint), Day 10 (endpoint), 1 wk post, 2 wks post, 4 wks post|||seconds||Standard Deviation|Mean
666889|NCT01749631|Secondary|Mean Number of Intubation Attempts||Start of intubation to completion of intubation (up to 15 minutes)|Per protocol population: all participants prescribed sevoflurane due to an anticipated difficulty in intubation during surgery and who met the study’s inclusion/exclusion criteria.||number of attempts||Standard Error|Mean
666890|NCT01749631|Secondary|Percentage of Participants Who Experienced Difficulties Related to the Use of Sevoflurane|The percentage of participants who experienced difficulties related to the use of sevoflurane including, but not limited to, vocal cords adduction, coughing, movements, and apnea episodes.|From start of induction to completion of intubation (up to 30 minutes)|ITT population: all participants prescribed sevoflurane due to an anticipated difficulty in intubation during surgery.||percentage of participants|||Number
666891|NCT01749631|Secondary|Percentage of Participants Who Experienced Complications Resulting From Intubation Procedure|The percentage of participants who experienced complications resulting from the intubation procedure including, but not limited to, bleeding, salivating, and lung aspiration.|Start of intubation to completion of intubation (up to 15 minutes)|ITT population: all participants prescribed sevoflurane due to an anticipated difficulty in intubation during surgery.||percentage of participants|||Number
666892|NCT01749631|Secondary|Mean Duration of Intubation Procedure (in Minutes)|The mean duration of intubation procedure (in minutes) was defined as the time from intubation start to the completion of the intubation process (from tube introduction to partial pressure of end-tidal carbon dioxide [PETCO2]).|Start of intubation to completion of intubation (up to 15 minutes)|Per protocol population: all participants prescribed sevoflurane due to an anticipated difficulty in intubation during surgery and who met the study’s inclusion/exclusion criteria.||minutes||Standard Error|Mean
666893|NCT01749631|Secondary|Percentage of Participants With Mallampati Score III and IV|Mallampati classification correlates tongue size to pharyngeal size. The test is performed with the patient in the sitting position, head in a neutral position, the mouth wide open and the tongue protruding to its maximum, without phonation. Classification is assigned according to the extent the base of tongue is able to mask the visibility of pharyngeal structures: Class I = visualization of the soft palate, fauces; uvula, anterior and the posterior pillars; Class II = visualization of the soft palate, fauces and uvula; Class III = visualization of soft palate and base of uvula; and Class IV: only hard palate is visible, soft palate is not visible at all. A high score (Class III or IV) is associated with more difficult intubation.|Screening|Per protocol population: all participants prescribed sevoflurane due to an anticipated difficulty in intubation during surgery and who met the study’s inclusion/exclusion criteria.||percentage of participants|||Number
666894|NCT01749631|Secondary|Mean Duration of Induction (in Seconds)|The mean duration of induction (in seconds) was defined as the time required to reach a Ramsay Sedation Score (RSS) of 5 from start of induction. The RSS levels are defined as 1 = anxious, agitated or restless; 2 = calm, co-operative and communicative; 3 = response is quick to a voice command; 4 = response is slow to a voice command; 5 = slow or sluggish response; and 6 = no response at all.|From start of induction up to 15 minutes|Per protocol population: all participants prescribed sevoflurane due to an anticipated difficulty in intubation during surgery and who met the study’s inclusion/exclusion criteria.||seconds||Standard Error|Mean
666895|NCT01749631|Primary|Percentage of Participants With Successful Intubation (Clinical Success)|Participants were considered to have a successful intubation if intubation was achieved in less than 4 separate intubation attempts according to the guidelines of the American Society of Anesthesiologists (ASA). The number of intubation attempts was a maximum of 3 attempts, after which the intubation was considered a failure.|Start of intubation to completion of intubation (up to 15 minutes)|Per protocol population: all participants prescribed sevoflurane due to an anticipated difficulty in intubation during surgery and who met the study’s inclusion/exclusion criteria.||percentage of participants|||Number
666896|NCT01749605|Primary|Number of Participants With Clinical Cure at Day 7|Seven days after randomization, subjects received a telephone call to determine if their symptoms have completely resolved. Patients answers were limited to: Yes (clinical cure), No (treatment failure)|7 days|||participants|||Number
666899|NCT01749410|Primary|Change From Baseline in the Number of Headache Days|The mean number of headache days was counted as the number of headache days occurring during the 30 day period ending with treatment cycle 7. Each treatment cycle was administered approximately every 12 weeks.|Treatment Cycle 7 (approximately 1.5 years)|All subjects who satisfied the inclusion and exclusion criteria||Days||Standard Deviation|Mean
666900|NCT01748955|Secondary|Change in Suicidal Ideation (SSI Score)|Beck Scale of Suicidal Ideation Minimum Value = 0 Maximum Value = 38 Higher score is more severe suicidal thoughts|Measured at Baseline and Week 8|||units on a scale||Standard Deviation|Mean
666901|NCT01748955|Primary|Percent Change in Contrast of Parameter Estimates (COPE)|"% change in COPE = (Post-treatment COPE - Pre-treatment COPE) / Pre-treatment COPE COPE is measured during Monetary Incentive Delay Task.
Task conditions are:
Reward= BOLD signal when subject wins 5 cents vs. wins 0 cents Punishment= BOLD signal when subject loses 5cents vs. loses 0 cents"|Measured at Baseline (pre-treatment) and Week 8 (post-treatment)|Major depressive disorder with suicidal thoughts or past suicide attempt.||Percentage change||Full Range|Mean
666902|NCT01748942|Secondary|Days With Feeding Tube||12 months|||days||Full Range|Median
666903|NCT01748942|Secondary|UM-QOL Eating|"The University of Michigan Head and Neck Quality of Life Questionnaire (UM-QOL) is 20 item, 1-5 scale, questionnaire that measures how much the patient has been bothered during various activities as a result of head and neck condition or treatment in the past four weeks with 1= Not at all and 5=Extremely. The scores are calculated using a Likert Scale, which transforms the 1-5 choices into a 0-100 scale with 100 being normal and 0 being poor quality of life. This test contains separate domains (eating, etc.) that can be scored independently. Scores were analyzed between cohorts pre and post operatively."|21 days|||units on a scale||Standard Deviation|Mean
666904|NCT01748942|Secondary|Opioid Use||3 days|||mg of oxycodone equivalent||Standard Deviation|Mean
666905|NCT01748942|Secondary|PSS Normalcy of Diet|"Performance Status Score (PSS) - Normalcy of Diet score is a 0-100 scale that measures diet restrictions with 0= Non-oral feeding (tube fed) and 100 = Full diet (no restrictions)"|30 days|||units on a scale||Standard Deviation|Mean
666907|NCT01748942|Secondary|Eating Assessment Tool (EAT)-10 Scores|"Statistical Analysis between placebo and steroid cohorts to assess differences. The Eating Assessment Tool (EAT-10) is a 10 item questionnaire that evaluates swallowing and the extent of how problematic with certain eating activities. Questions are answered using a five point (0-4) plus Not Applicable scale with 0 = No problem and 4= Severe problem. A descriptive time plot will be produced for EAT-10 scores using baseline and postoperative measurements on days 3 and day 7-21. Descriptive statistical analyses will be conducted for a summary of EAT-10 scores at baseline, days 3 and day 7-21 after surgery. A linear mixed effects model will be used to compare the EAT-10 scores between the two groups."|Up to 12 months|||units on a scale||Standard Deviation|Mean
666908|NCT01748942|Secondary|Complications Associated With Postoperative Corticosteroid Use After TORS|A descriptive statistical analysis will be conducted on complications.|Up to 30 days|||Participants|||Count of Participants
666909|NCT01748942|Primary|Pain Visual Analogue Scale (VAS) Score Measured at 10-point Scale|"Visual Analog Scale (VAS) is a 0-10 scale for patients to indicate intensity level of pain with 0 indicating No pain and 10 indicating Worst possible, unbearable, excruciating pain. A descriptive time plot of VAS scores will be produced for all enrolled subjects, with loess curve fitted separately for the experimental and control groups. A linear mixed effects model will be used to compare the pain VAS scores between the experimental and control groups."|21 days|||units on a scale||Standard Deviation|Mean
666910|NCT01748916|Primary|Pharmacokinetics of Carotenoid Absorption From Papaya, Carrot and Tomato|The primary goal of this research is to investigate whether papaya can deliver increased quantities of carotenoids when compared to carrot and tomato. An area under the curve for concentration of carotenoids (from triglyceride rich lipoprotein (TRL) fraction of plasma) over time will be determined to quantify absorption, after subjects consume a meal containing papaya, carrot or tomato.|8 post-prandial blood samples over 9.5 hours|||nmol*h/L||Inter-Quartile Range|Median
666912|NCT01748799|Secondary|Cannabis Withdrawal|Withdrawal symptoms were assessed using the Cannabis Withdrawal Scale (CWS) (Minimum-Maximum Scores 0-190, high scores represent more withdrawal) and Cannabis Withdrawal Checklist (CWC) (Minimum-Maximum Scores 0-48, high scores represent more withdrawal) by establishing comparisons between Sativex/Placebo and Smoke as usual conditions (4 interventions: Fixed Sativex, Fixed Placebo, Self-titrated Sativex, Self-titrated Placebo and 4 corresponding Smoke as usual conditions).|8 weeks|Only 9 of the 16 participants recruited completed the whole experimental sequence (participants were assigned to 1 of 8 different experimental sequences in a randomized order).||units on a scale||Standard Deviation|Mean
666913|NCT01748799|Secondary|Tolerability of Sativex in Persons That Are Cannabis Dependent|To assess what number of participants might withdrew due non-tolerability of Sativex|8 weeks|Data from 16 participants enrolled in the study was analyzed, none of the participants withdrew due non-tolerability of Sativex||participants|||Number
666914|NCT01748799|Primary|Feasibility|Feasibility will be assessed by analysing how many participants can be recruited/complete the whole (randomly assigned) experimental sequence with a period of one year.|12 months|16 participants were enrolled in the study, 9 participants completed the whole (randomly assigned) experimental sequence||participants|||Number
666915|NCT01748760|Primary|Number of Participants Who Repoorted a Suicide Event|A suicide event is either a suicide attempts (actual, aborted, interrupted), or emergency interventions to intercede an attempt.|6 months|||participants|||Number
666916|NCT01748695|Primary|Safety and Tolerability of V158866 Compared to Placebo|Safety and tolerability were measured by occurrence of treatment-emergent adverse events; data represents the number of subjects who experienced treatment-emergent adverse events during each treatment period.|4 weeks|||Participants|||Count of Participants
666917|NCT01748695|Primary|Mean Pain Intensity (NRS)|Numerical Rating Scale, measuring the intensity of pain from 0 to 10, with 0 being no pain and 10 being worst pain imaginable. The comparison of the overall pain intensity, calculated as the mean of the last 7 days on treatment, for each treatment period (V158866 compared to placebo).|4 Weeks|||units on a scale||Standard Error|Mean
666918|NCT01748643|Secondary|Forced Vital Capacity|Forced vital capacity is measured with the Vitalograph® electronic portable peak flow meter. A mean of 3 measurements in the upright posture in bed before and after surgery will be used.|Measured the day before surgery and 30min after completion of surgery (when the modified observer's assessment of alertness/sedation scale is 5 (Patient responds readily to name spoken in normal tone))|||percent change from baseline||Standard Deviation|Mean
666919|NCT01748643|Secondary|Forced Expiratory Volume in 1 Second|Forced expiratory volume in 1 second is measured with the Vitalograph® electronic portable peak flow meter. A mean of 3 measurements in the upright posture in bed before and after surgery will be used.|Measured the day before surgery and 30min after completion of surgery (when the modified observer's assessment of alertness/sedation scale is 5 (Patient responds readily to name spoken in normal tone))|||percent change from baseline||Standard Deviation|Mean
666920|NCT01748643|Secondary|Peak Expiratory Flow|Peak expiratory flow is measured with the Vitalograph® electronic portable peak flow meter. A mean of 3 measurements in the upright posture in bed before and after surgery will be used.|Measured the day before surgery and 30min after completion of surgery (when the modified observer's assessment of alertness/sedation scale is 5 (Patient responds readily to name spoken in normal tone))|||percent change from baseline||Standard Deviation|Mean
666921|NCT01748643|Primary|Duration of Surgery|Measured from the time of first skin incision to completion of skin closure.|Participants will be followed for the duration of the laparoscopic gastric bypass surgery, an expected average of 1.5h|||minutes||Standard Deviation|Mean
666922|NCT01748643|Primary|Number of Intra-abdominal Pressure Rises > 18cmH2O|The number of intra-abdominal pressure rises > 18cmH2O detected by the intra-abdominal CO2 insufflator.|Participants will be followed for the duration of the laparoscopic gastric bypass surgery, an expected average of 1.5h|||number of intra-abdominal pressure rises||Standard Deviation|Mean
668251|NCT01729026|Secondary|Beck Depression Inventory - II (BDI-II)|Self-rating scale that assesses the frequency and severity of common symptoms of depression|Baseline and 1-month, 3-month, 4-month, and 6-month follow-up||||||
666923|NCT01748643|Primary|Subjective Evaluation of the View on the Operating Field by the Surgeon|"At the end of surgery, the view on the operating field will be graded by the surgeon using a 5-point rating scale:
Extremely poor
Poor
Acceptable
Good
Optimal"|Participants will be followed for the duration of the laparoscopic gastric bypass surgery, an expected average of 1.5h|||units on a scale||Standard Deviation|Mean
666924|NCT01748227|Secondary|Pain Centrality Scale|Possible range 10-50. Higher scores indicate higher pain centrality, i.e., worse outcomes.|4 month assessment|||units on a scale||Standard Deviation|Mean
666925|NCT01748227|Secondary|Patient Reported Outcome Measurement System (PROMIS)|Possible scores range 0-100. Higher scores represent higher pain interference. Thus lower scores represent better outcomes.|Change from baseline to 4 month assessment|||units on a scale||Standard Deviation|Mean
666926|NCT01748227|Secondary|Multidimensional Perceived Social Support Scale (MPSS).|12 items, possible range 12-84 with higher scores indicating higher social support (i.e., better outcomes).|Baseline and 4 month for Statistical Package for Social Scientists (SPSS) and only 4 month final interview for Working Alliance|||units on a scale||Standard Deviation|Mean
666927|NCT01748227|Secondary|Pain Catastrophizing Scale|Pain Catastrophizing Scale. 13-item scale. Possible score range 0-52, with lower scores representing improvement.|Baseline and 4 month assessment (final assessment)|||units on a scale||Standard Deviation|Mean
666928|NCT01748227|Primary|Pain/Enjoyment of Life/General Activity|3-item version of the Brief Pain Inventory. Possible range: 0-30. 0=no pain/interference, 30=maximum pain/interference. Thus lower values represent a better outcome.|Change from baseline to 4 month assessment|||units on a scale||Standard Deviation|Mean
666929|NCT01748071|Secondary|Mean Respiratory Frequency|According to the measurement of respiratory frequency after intravenous injection of opioid analgesics|10 minutes after the procedure|||breaths per minute||Standard Deviation|Mean
666930|NCT01748071|Secondary|Mean Heart Rate|According to the measurement of heart rate before and after intravenous injection of opioid analgesics|10 minutes after the procedure|||beats per minute||Standard Deviation|Mean
666931|NCT01748071|Secondary|Mean Arterial Pressure|According to the measurement of mean arterial pressure before and after intravenous injection of opioid analgesics|10 minutes after the procedure|||mmHg||Standard Deviation|Mean
666932|NCT01748071|Primary|Mean Value of Narco-trend Index|According to the measurement of Nacro-trend index after intravenous injection of opioid analgesics. Narco-trend index is from 0 to 100 which 0 represent deep sedation, and 100 represent waking state.|10 minutes after the procedure|||units on a scale||Standard Deviation|Mean
666933|NCT01748071|Primary|Mean Pressure Pain Threshold|According to the measurement of pressure pain threshold after intravenous injection of opioid analgesics|10 minutes after the procedure|||kg/cm2||Standard Deviation|Mean
666934|NCT01748045|Secondary|Total Duration of Respiratory Support|participants were followed for the duration of hospital stay for respiratory support|From hospital admission through discharge|||days||Standard Deviation|Mean
666935|NCT01748045|Secondary|Evidence of Chronic Respiratory Morbidity at 12 Months Corrected Gestational Age (CGA)|defined by a validated system of parental diaries and pulmonary questionnaires, as well as review of medical records (medical visits, respiratory medication use, emergency room visits, and hospital re-admissions)|12 months corrected gestational age|Analysis not performed at one year corrected age, since study closed.||Participants|||Count of Participants
666936|NCT01748045|Secondary|Diagnosis of Bronchopulmonary Dysplasia (BPD)|Diagnosis of BPD by oxygen challenge test at 36 weeks post menstrual age (PMA) for infants born between 30 and 32 weeks gestational age (GA). For those born 32 1/7 - 36 weeks, an oxygen challenge test was performed at 1-2 months of age.|At 36 weeks postmenstrual age or 1-2month of age|||Participants|||Count of Participants
666937|NCT01748045|Secondary|Total Duration of Supplemental Oxygen|Participants were followed for the duration of hospital stay for use of supplemental oxygen|From Hospital Admission through discharge|||days||Standard Deviation|Mean
666938|NCT01748045|Secondary|Total Length of Hospital Stay|participants who were followed for the duration of hospital stay|From hospital admission through discharge|||days||Standard Deviation|Mean
666939|NCT01748045|Secondary|Number of Participants Who Had the Need for Exogenous Surfactant||7 days|||Participants|||Count of Participants
666940|NCT01748045|Primary|Number of Participants Who Were Alive Without the Need for Intubation or Mechanical Ventilation Within the First Week of Life||7 days|||Participants|||Count of Participants
666941|NCT01747928|Secondary|Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q17|OAT, Q17: Participant understood reason excess liquid was present after a partial-dose injection. Observer responses were reported as follows: Yes, No. Q11 to Q17 made up Segment 5: Performing the Simulated Injection.|Day 1|"FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination. All participants in the 10 mcg device-10 mcg dose and 20 mcg device-20 mcg dose (total 12 participants) are stated as not applicable as they tested the full dose."||participants|||Number
666942|NCT01747928|Secondary|Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q16|OAT, Q16: Evidence of mechanical malfunction/defect. Observer responses were reported as follows: Yes, No. Q11 to Q17 made up Segment 5: Performing the Simulated Injection.|Day 1|FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination.||participants|||Number
666943|NCT01747928|Secondary|Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q14b|OAT, Q14b: Participant successfully expelled/injected the assigned dose (per Dose Card). Observer responses were reported as follows: Yes, No. Q11 to Q17 made up Segment 5: Performing the Simulated Injection.|Day 1|FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination.||participants|||Number
666944|NCT01747928|Secondary|Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q13|"OAT, Q13: Was there any difficulty/obstruction encountered in expelling dose? Observer responses were reported as follows: Yes, No. A Yes response indicated failure according to the SAP. Q11 to Q17 made up Segment 5: Performing the Simulated Injection."|Day 1|FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination.||participants|||Number
667029|NCT01746784|Secondary|Change in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1)|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson standards were used to calculate percent predicted FEV1 (for age, sex, and height).|Change from baseline at Day 7|Change in Forced Expiratory Volume in 1 second (FEV1) from baseline to Study Day 7||percentage||Standard Deviation|Mean
666945|NCT01747928|Secondary|Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q12|"OAT, Q12: Participant successfully expelled the dose into the target. Observer responses were reported as follows: Yes, No. A No response indicated failure according to the OAT. Q11 to Q17 made up Segment 5: Performing the Simulated Injection."|Day 1|FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination.||participants|||Number
666946|NCT01747928|Secondary|Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q11|"OAT, Q11: Participant successfully set the correct dose (as assigned). Observer responses were reported as follows: Yes, No. A No response indicated failure according to the OAT. Q11 to Q17 made up Segment 5: Performing the Simulated Injection."|Day 1|FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination.||participants|||Number
666947|NCT01747928|Secondary|Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q10|OAT, Q10: Evidence of mechanical malfunction/defect for Segment 4. Observer responses were reported as follows: Yes, No. Q9 and Q10 made up Segment 4: Setting the Dose.|Day 1|FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination.||participants|||Number
666948|NCT01747928|Secondary|Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q9|"OAT, Q9: Participant was able to set a dose (any dose) for delivery. Observer responses were reported as follows: Yes, No. A No response indicated failure according to the OAT. Q9 and Q10 made up Segment 4: Setting the Dose."|Day 1|FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination.||participants|||Number
666949|NCT01747928|Secondary|Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q8|OAT, Q8: Evidence of mechanical malfunction/defect for Segment 3. Observer responses were reported as follows: Yes, No. Q6 to Q8 made up Segment 3: De-aeration of the Syringe.|Day 1|FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination.||participants|||Number
666950|NCT01747928|Secondary|Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q7|"OAT, Q7: Participant depressed the plunger correctly to de-aerate the syringe. Observer responses were reported as follows: Yes, No. A No response indicated failure according to the SAP. Q6 to Q8 made up Segment 3: De-aeration of the Syringe."|Day 1|FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination.||participants|||Number
666951|NCT01747928|Secondary|Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q6|"OAT, Q6: De-aeration step performed successfully. Observer responses were reported as follows: Yes, No. A No response indicated failure according to the OAT. Q6 to Q8 made up Segment 3: De-aeration of the Syringe."|Day 1|"FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination. 1 participant each in the 10 mcg device-2.5 mcg dose and the 20 mcg device-10 mcg dose were excluded as they failed in Segment 1 and did not proceed to Segment 2. These 2 participants are counted in the did not participate category."||participants|||Number
666952|NCT01747928|Secondary|Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q5|OAT, Q5: Evidence of mechanical malfunction/defect for Segment 2. Observer responses were reported as follows: Yes, No. Q3 to Q5 made up Segment 2: Mixing the Solution.|Day 1|"FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination. 1 participant each in the 10 mcg device-2.5 mcg dose and the 20 mcg device-10 mcg dose were excluded as they failed in Segment 1 and did not proceed to Segment 2. These 2 participants are counted in the did not participate category."||participants|||Number
666953|NCT01747928|Secondary|Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q4|"OAT, Q4: Participant positioned piston correctly. Observer responses were reported as follows: Yes, No. A No response indicated failure according to the SAP. Q3 to Q5 made up Segment 2: Mixing the Solution."|Day 1|"FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination. 1 participant each in the 10 mcg device-2.5 mcg dose and the 20 mcg device-10 mcg dose were excluded as they failed in Segment 1 and did not proceed to Segment 2. These 2 participants are counted in the did not participate category."||participants|||Number
666954|NCT01747928|Secondary|Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q3|"OAT, Q3: Participant performed mixing step correctly. Observer responses were reported as follows: Yes, No. A No response indicated failure according to the OAT. Q3 to Q5 made up Segment 2: Mixing the Solution."|Day 1|"FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination. 1 participant each in the 10 mcg device-2.5 mcg dose and the 20 mcg device-10 mcg dose were excluded as they failed in Segment 1 and did not proceed to Segment 2. These 2 participants are counted in the did not participate category."||participants|||Number
666955|NCT01747928|Secondary|Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q2|OAT, Q2: Evidence of mechanical malfunction or defect for Segment 1. Observer responses were reported as follows: Yes, No. Q1 and Q2 made up Segment 1: Assembly of Components.|Day 1|FAS: all protocol defined valid attempts to perform the study procedures as documented in the OAT. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination. 1 participant in the 10 mcg device-2.5 mcg dose was excluded as failure at Q1 did not involve mechanical failure or defect.||participants|||Number
666956|NCT01747928|Secondary|Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q1|"OAT, Q1: Participant assembled the components correctly. Observer responses were reported as follows: Yes, No. A No answer indicated failure according to the OAT. Q1 and Q2 made up Segment 1: Assembly of Components."|Day 1|FAS: all protocol defined valid attempts to perform the study procedures as documented in the OAT. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination.||participants|||Number
666957|NCT01747928|Secondary|Time Required to Perform Segments 1 to 5|Steps involved while using the Caverject Impulse Delivery System were categorized into segments: Segment 1 (Assembly While Using the Caverject Impulse Delivery System), Segment 2 (Mixing the Solution), Segment 3 (De-aerating the Syring While Using the Caverject Impulse Delivery System), Segment 4 (Setting the Dose) and Segment 5 (Performing the Injection While Using the Caverject Impulse Delivery System).|Day 1|The FAS consisted of all protocol defined valid attempts to perform the study procedure as documented in the OAT. n=number of participants analyzed for that segment.||seconds||Standard Deviation|Mean
667438|NCT01740089|Primary|Number of Randomized Patients Achieving Early Virologic Response (EVR) - Negative PCR Result for HCV RNA (< 15 IU/ml) or ≥ 2log10 Decrease of Viral Load After 12 Weeks of Study Treatment.||12 weeks|||participants|||Number
666958|NCT01747928|Secondary|Number of Participants Providing Responses to Any Question on the PAT|Number of participants providing responses on questions in the PAT. Questions were as follows: What step did you stop? Why?; Instructions provided were useful?; Instructions provided were clear?; Most difficult step?; Syringe easy to use?|Day 1|The FAS consisted of all protocol defined valid attempts to perform the study procedure as documented in the OAT.||participants|||Number
666959|NCT01747928|Secondary|Number of Participants With Categorical Responses to the PAT: Syringe Easy to Use?|Participant responses were reported as follows: Very easy, Somewhat easy, Somewhat difficult, Very difficult.|Day 1|The FAS consisted of all protocol defined valid attempts to perform the study procedure as documented in the OAT.||participants|||Number
666960|NCT01747928|Secondary|Number of Participants With Categorical Responses to the PAT: Most Difficult Step?|Participant responses were reported as follows: No steps really difficult, Attaching needle, Mixing the solution, Getting the air out of syringe, Setting the dose, Pushing plunger, Other.|Day 1|The FAS consisted of all protocol defined valid attempts to perform the study procedure as documented in the OAT.||participants|||Number
666961|NCT01747928|Secondary|Number of Participants With Categorical Responses to the PAT: Instructions Provided Were Clear?|Participant responses were reported as follows: Very clear, Somewhat clear, Not very clear, Not clear at all.|Day 1|The FAS consisted of all protocol defined valid attempts to perform the study procedure as documented in the OAT.||participants|||Number
666962|NCT01747928|Secondary|Number of Participants With Categorical Responses to the Participant Assessment Tool (PAT): Instructions Provided Were Useful?|Participant responses were reported as follows: Very Useful, Somewhat Useful, Not Very Useful, Not Useful At All.|Day 1|The FAS consisted of all protocol defined valid attempts to perform the study procedure as documented in the OAT.||participants|||Number
666963|NCT01747928|Post-Hoc|DSSR Based on the Primary Objective|This post-hoc DSSR was calculated in order to provide a DSSR that recognized as a “failure” only those participants who were unable to successfully complete the overall injection task, regardless of whether they met with difficulties at any step.|Day 1|The FAS consisted of all protocol defined valid attempts to perform the study procedure as documented in the OAT.||percentage of participants||95% Confidence Interval|Number
666964|NCT01747928|Primary|Delivery System Success Rate (DSSR)|"DSSR was defined as percentage of participants who were able to successfully expel the selected dose from the Caverject Impulse Dual Chamber Delivery System when relying on the modified Instructions for Use (IFU). The process was considered successful if the attempt was observed and documented by study personnel AND the participant didn't receive any operational/hands on demonstration on how to operate the plunger from study personnel AND after performing all preparatory steps, the participant was able to expel the dose to the selected plunger stop-point without any unexpected interruption."|Day 1|The full analysis set (FAS) consisted of all protocol defined valid attempts to perform the study procedure as documented in the Observer Assessment Tool (OAT).||percentage of participants||95% Confidence Interval|Number
666965|NCT01747850|Secondary|Cannabis Use (Grams)|Amount of cannabis used in grams over the study duration until 6 month follow-up will be assessed|six months|||grams of cannabis||Standard Error|Mean
666966|NCT01747850|Secondary|Cannabis Craving|"Effect of Sativex on cannabis craving will be assessed using the Marijuana Craving Questionnaire (MCQ). Average Total score for the trial (6 months) is reported.
Participants rate the 12 items using a 7-item Likert scale ranging from strongly disagree to strongly agree, and the total score ranges from 4 to 28 (subscales compulsivity (mean items 2, 7 and 10), emotionality (mean items 4, 6 and 9), expectancy (mean items 5, 11 and 12) and purposefulness (mean items 1, 3 and 8); total score is the sum for the 4 subscales). Higher scores indicate more severe craving for marijuana."|six months|||Total Craving Scores||Standard Deviation|Mean
666967|NCT01747850|Secondary|Withdrawal|"Effect of Sativex on withdrawal symptom scores will be assessed using the Marijuana Withdrawal Checklist (MWC). Average Total score for the trial (6 months) is reported.
Range 0 – 46. Higher scores indicate more severe symptoms associated with marijuana withdrawal."|six months|||Total Withdrawal score||Standard Deviation|Mean
666968|NCT01747850|Secondary|Cannabis Use (in Days)|The percentage of days that participants self-reported use of cannabis over the study duration until 6 month follow-up will be assessed (i.e. smoking diary self-report)|six months|||percentage of days||Standard Deviation|Mean
666969|NCT01747850|Primary|Tolerability|Assessment of tolerability will be determined by the number of subjects that withdrawal from the study due to SAEs.|six months|||Participants|||Count of Participants
666970|NCT01747811|Other Pre-specified|Change From Baseline in Beck Depression Inventory (BDI-II) Scores at 6 Weeks|The Beck Depression Inventory (BDI-II) is a self report scale utilized for measuring the severity of depression. Scores can range from 0-63 (0 meaning minimal depressive symptoms, and 63 being severe depressive symptoms). Participants are given this on baseline and post treatment.|Change from baseline at 6 weeks (post-treatment)|||units on a scale||Standard Deviation|Mean
666971|NCT01747811|Secondary|Performance on Neuropsychological Assessment|The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) is a neuropsychological assessment that measures different facets of memory including the following: immediate memory, visuospatial/constructional, language, attention, and delayed memory. This is given to all participants on both pre and post treatment visits. The total range for this scale is 40-160. Lower values represent a worse outcome, and higher values represent an improved outcome.|Change from baseline at 6 weeks (post-treatment)|||units on a scale||Standard Deviation|Mean
666972|NCT01747811|Secondary|Actigraphy-measured Sleep Quality|Actigraphy is an objective measure that determines sleep vs. wake. It is a watch with an accelerometer worn on the wrist. Sleep quality is determined by the amount of time in bed divided by the amount of time sleeping (in minutes).|Change from baseline at 6 weeks (post-treatment)|We collected usable actigraphy from 29 participants. The 7 remaining participants had unusable actigraphy data.||minutes||Standard Deviation|Mean
666973|NCT01747811|Secondary|Score on Pittsburgh Sleep Quality Index (PSQI)|The Pittsburgh Sleep Quality Index is a self report measure of sleep quality. The overall score takes into account many different facets of sleep, such as sleep quality, sleep latency, sleep duration, sleep disturbances, etc. The scores range from 0-21, and any score that is equal to or greater than 5 is indicative of poor sleep quality.|Change from baseline at 6 weeks (post-treatment)|||units on a scale||Standard Deviation|Mean
667482|NCT01738698|Secondary|Change From Baseline in Simpson Angus Scale (SAS) Total Score at 12 Weeks||Baseline and 12 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
666974|NCT01747811|Secondary|Neural Activation During Functional Magnetic Resonance Imaging (fMRI) Executive Function Task|Change from baseline in left prefrontal cortical response during a multi source interference task at six weeks. Methods utilized to assess activity in the left prefrontal cortex/inferior frontal operculum included a regions of interest analysis.|Change from baseline performance at 6 weeks (post-treatment)|A total of 22 participants had useable data, 4 participants were excluded due to movement in the images.||Percent Signal Change||Standard Deviation|Mean
666975|NCT01747811|Primary|Performance on Multiple Sleep Latency Test (MSLT)|The MSLT is a objective measure of sleepiness. Participants will take a brief nap 3 times during the 1st and second visit. The period of time between wake and sleep onset will be utilized as an objective measure of sleepiness (in minutes). A mean value will be calculated for the entirety of the pre-treatment napping periods and for the post treatment visits.|Change from baseline performance at 6 weeks (post-treatment)|||minutes||Standard Deviation|Mean
666976|NCT01747772|Primary|Liver Elasticity Value Measured Using Sonoelastography (SE)|Liver elasticity/stiffness was assessed via SE and compared against results of liver biopsy as read by a single pathologist using the Meta-analysis of Histological Data in Viral Hepatitis (METAVIR) 5-point scale (F [Fibrosis]0=no fibrosis, F1=portal fibrosis without septa, F2=portal fibrosis with few septa, F3=numerous septa without cirrhosis, and F4=cirrhosis). Using SE, fibrosis is measured in kilopascals (kPa) with normal values equaling approximately 5.5 kPa (normal liver stiffness ranges between 3.3-7.8 kPa). Significant Fibrosis (F3): = or > 7.6 kPa, Cirrhosis (F4): = or > 9.0- 26 kPa. A higher number corresponds to an increase in stiffness and hepatic fibrosis.|Day 1|The analysis population included all participants who completed the study and had adequate shear-wave sonoelastography (SWE) and liver biopsy data. 16 participants were excluded: 9 discontinued and 7 had inadequate SWE or biopsy data.||kilopascals (kPa)||95% Confidence Interval|Mean
666977|NCT01747655|Secondary|Healthcare Resource Utilization (HCRU) Falls: Percentage of Participants With Falls at 3, 6, and 12 Months After Hospital Discharge|Participants were asked about their utilization of healthcare resources within the previous 3 months , including total number of office visits, total number of visits at home for Parkinson's disease, total number of emergency situations (overnight hospital stay, visit at emergency room, calls for immediate assistance [family/friend)], and calls to 911/emergency), received assistance at home (family/friend or paid caregiver), and falls. n=the number of participants with data at baseline and given time point.|Baseline (Week 0) and 3, 6, and 12 months after hospital discharge|MAS population||percentage of participants|||Number
666978|NCT01747655|Secondary|Healthcare Resource Utilization (HCRU) Received Assistance at Home: Percentage of Participants Who Received Assistance at Home at 3, 6, and 12 Months After Hospital Discharge|Participants were asked about their utilization of healthcare resources within the previous 3 months, including total number of office visits, total number of visits at home for Parkinson's disease, total number of emergency situations (overnight hospital stay, visit at emergency room, calls for immediate assistance [family/friend)], and calls to 911/emergency), received assistance at home (family/friend or paid caregiver), and falls. n=the number of participants with data at given time point.|Baseline (Week 0) and 3, 6, and 12 months after hospital discharge|MAS population||percentage of participants|||Number
666979|NCT01747655|Secondary|Healthcare Resource Utilization (HCRU) Emergency Situations: Percentage of Participants With Emergency Situations at 3, 6, and 12 Months After Hospital Discharge|Participants were asked about their utilization of healthcare resources within the previous 3 months, including total number of office visits, total number of visits at home for Parkinson's disease, total number of emergency situations (overnight hospital stay, visit at emergency room, calls for immediate assistance [family/friend)], and calls to 911/emergency), received assistance at home (family/friend or paid caregiver), and falls. n=the number of participants with data at given time point.|Baseline (Week 0) and 3, 6, and 12 months after hospital discharge|MAS population||percentage of participants|||Number
666980|NCT01747655|Secondary|Healthcare Resource Utilization (HCRU) Number of Visits at Home: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge|Participants were asked about their utilization of healthcare resources within the previous 3 months, including total number of office visits, total number of visits at home for Parkinson's disease, total number of emergency situations (overnight hospital stay, visit at emergency room, calls for immediate assistance [family/friend)], and calls to 911/emergency), received assistance at home (family/friend or paid caregiver), and falls. n=the number of participants with data at baseline and given time point.|Baseline (Week 0) and 3, 6, and 12 months after hospital discharge|MAS population||visits at home||Standard Deviation|Mean
666981|NCT01747655|Secondary|Healthcare Resource Utilization (HCRU) Number of Office Visits: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge|Participants were asked about their utilization of healthcare resources within the previous 3 months, including total number of office visits, total number of visits at home for Parkinson's disease, total number of emergency situations (overnight hospital stay, visit at emergency room, calls for immediate assistance [family/friend)], and calls to 911/emergency), received assistance at home (family/friend or paid caregiver), and falls. n=the number of participants with data at baseline and given time point.|Baseline (Week 0) and 3, 6, and 12 months after hospital discharge|MAS population||office visits||Standard Deviation|Mean
666982|NCT01747655|Secondary|Parkinson’s Disease Quality of Life Questionnaire (PDQ-8) Summary Index Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge|Participants were asked to state how often they had encountered certain problems over the past four weeks using the following rating scale: Never (0), occasionally (1), sometimes (2), often (3), always or cannot do at all (4). The PDQ-8 summary index was derived as the sum of the single items divided by 32. Scores range from 0 to 100. A higher summary index score indicates a higher impairment of quality of life. Observed values are presented for each visit as well as LOCF at 12 months after discharge. n=the number of participants with data at baseline and given time point.|Baseline (Week 0), at discharge from hospital, and 3, 6, and 12 months after hospital discharge|MAS population||units on a scale||Standard Deviation|Mean
667030|NCT01746784|Primary|Safety and Tolerability|Assessments are based on numbers of subjects with abnormal clinical evaluations, abnormal laboratory assessments, and adverse events.|Over 7 treatment days and 7 days of follow-up|Treatment emergent adverse events by Grade 1 (mild) to 5 (fatal)||participants|||Number
667031|NCT01746511|Secondary|Length of Initial Round of Phototherapy|time start to time finally off phototherapy, including any breaks during which they were off|from time of enrollment to time of discharge, for a maximum of 10 weeks|||hours||Standard Deviation|Mean
666983|NCT01747655|Secondary|Non-Motor Symptoms Assessment Scale for Parkinson’s Disease (NMSS Rating Scale) Total Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge|Non-motor symptoms assessed over the previous month were scored with respect to severity (0 = none, 1 = mild, 2 = moderate, 3 = severe) and with respect to frequency (1 = rarely, 2 = often, 3 = frequent, 4 = very frequent). The total NMSS score ranges from 0 to 360 with higher values indicating greater impairment and was calculated as the sum of all individual score values. Observed values are presented for each visit as well as LOCF at 12 months after discharge. n=the number of participants with data at baseline and given time point.|Baseline (Week 0) and 3, 6, and 12 months after hospital discharge|MAS population||units on a scale||Standard Deviation|Mean
666984|NCT01747655|Secondary|Unified Parkinson’s Disease Rating Scale (UPDRS) III (Motor Examination) Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge|The UPDRS III questionnaire consists of 14 questions on motor examinations rated from 0 (absent/normal) to 4 (extreme impairment). Questions 20–26 are multi-part questions in that they are evaluated separately for multiple body parts (for example, for the left and right hand). Counting each of these assessments leads to a total of 27 answers. The UPDRS III score ranges from 0 to 108 with higher values indicating greater impairment and was calculated as the sum of the 27 answers provided to the 14 questions. Observed values are presented for each visit as well as LOCF at 12 months after discharge. n=the number of participants with data at baseline and given time point.|Baseline (Week 0) and 3, 6, and 12 months after hospital discharge|MAS population||units on a scale||Standard Deviation|Mean
666985|NCT01747655|Secondary|Unified Parkinson’s Disease Rating Scale (UPDRS) IV (Complications of Therapy) Item 39 (Clinical Fluctuations) Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge|"The UPDRS IV questionnaire consists of 4 individual items that assess the degree of dyskinesias (Item 32: duration; Item 33: disability; and Item 34: pain) and clinical fluctuations (Item 39: percentage of off times of the waking day). Individual UPDRS IV item scores range from 0 to 4. Higher scores indicate a higher complication of therapy. Observed values are presented for each visit as well as LOCF at 12 months after discharge. n=the number of participants with data at baseline and given time point."|Baseline (Week 0) and 3, 6, and 12 months after hospital discharge|MAS population||units on a scale||Standard Deviation|Mean
666986|NCT01747655|Secondary|Unified Parkinson’s Disease Rating Scale (UPDRS) IV (Complications of Therapy) Item 34 (Pain) Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge|"The UPDRS IV questionnaire consists of 4 individual items that assess the degree of dyskinesias (Item 32: duration; Item 33: disability; and Item 34: pain) and clinical fluctuations (Item 39: percentage of off times of the waking day). Individual UPDRS IV item scores range from 0 to 4. Higher scores indicate a higher complication of therapy. Observed values are presented for each visit as well as LOCF at 12 months after discharge. n=the number of participants with data at baseline and given time point."|Baseline (Week 0) and 3, 6, and 12 months after hospital discharge|MAS population||units on a scale||Standard Deviation|Mean
666987|NCT01747655|Secondary|Unified Parkinson’s Disease Rating Scale (UPDRS) IV (Complications of Therapy) Item 33 (Disability) Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge|"The UPDRS IV questionnaire consists of 4 individual items that assess the degree of dyskinesias (Item 32: duration; Item 33: disability; and Item 34: pain) and clinical fluctuations (Item 39: percentage of off times of the waking day). Individual UPDRS IV item scores range from 0 to 4. Higher scores indicate a higher complication of therapy. Observed values are presented for each visit as well as LOCF at 12 months after discharge. n=the number of participants with data at baseline and given time point."|Baseline (Week 0) and 3, 6, and 12 months after hospital discharge|MAS population||units on a scale||Standard Deviation|Mean
666988|NCT01747655|Secondary|Unified Parkinson’s Disease Rating Scale (UPDRS) IV (Complications of Therapy) Item 32 (Duration) Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge|"The UPDRS IV questionnaire consists of 4 individual items that assess the degree of dyskinesias (Item 32: duration; Item 33: disability; and Item 34: pain) and clinical fluctuations (Item 39: percentage of off times of the waking day). Individual UPDRS IV item scores range from 0 to 4. Higher scores indicate a higher complication of therapy. Observed values are presented for each visit as well as LOCF at 12 months after discharge. n=the number of participants with data at baseline and given time point."|Baseline (Week 0) and 3, 6, and 12 months after hospital discharge|MAS population||units on a scale||Standard Deviation|Mean
666989|NCT01747655|Secondary|Primary Reasons for Discontinuing Duodopa Treatment or for Discontinuing the Study|The primary reasons for stopping treatment with Duodopa or for discontinuing the study.|12 months|Participants in the MAS who stopped treatment with Duodopa or discontinued from study.||participants|||Number
666990|NCT01747655|Secondary|Percentage of Participants Who Continued With Jejunal Extension Tube of the Percutaneous Endoscopic Gastrostomy (PEG-J) Treatment|The percentage of participants who continued with PEG-J treatment after treatment via temporary naso-jejunal tube.|14 days|MAS population||percentage of participants|||Number
666991|NCT01747655|Secondary|Unified Parkinson’s Disease Rating Scale (UPDRS) II (Activities of Daily Living) Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge|"The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part II score is the sum of the answers to 13 questions, each of which are measured on a 5-point scale (0-4). The Part II score ranges from 0-52 and higher scores are associated with more disability. UPDRS scores during On time (when PD symptoms are well controlled by the drug) are presented. n=the number of participants with data at baseline and given time point."|Baseline (Week 0) and 3, 6, and 12 months after hospital discharge|MAS population||units on a scale||Standard Deviation|Mean
666992|NCT01747655|Primary|Unified Parkinson’s Disease Rating Scale (UPDRS) II (Activities of Daily Living) Score: Mean Change From Baseline to 12 Months After Hospital Discharge|"The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part II score is the sum of the answers to 13 questions, each of which are measured on a 5-point scale (0-4). The Part II score ranges from 0-52 and higher scores are associated with more disability. UPDRS scores during On time (when PD symptoms are well controlled by the drug) are presented. Last observation carried forward (LOCF) was used for missing data."|Baseline (Week 0) and 12 months after hospital discharge|MAS population||units on a scale||Standard Deviation|Mean
667032|NCT01746511|Secondary|Rate of Decline in Bilirubin Levels (mg/dL/hr)|Absolute change over time from peak to first discontinuation of phototherapy lights|from time of enrollment to time of discharge, for a maximum of 10 weeks|||mg/dL/hr||Standard Deviation|Mean
666993|NCT01747629|Secondary|Terminal Plasma Half-life (t1/2) for Albuterol on Days 1 and 8|Pharmacokinetic parameters of albuterol were determined on Day 1 after the first dose administration and at steady-state on Day 8. Day 1 serial (10-hr) blood samples for pharmacokinetics pre-dose (within 30 minutes prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5, 6, 8 and 10 hours (±10 minutes). Day 8 serial (6-hr) blood samples for pharmacokinetics pre-dose (within 30 min prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5 and 6 hr (±10 min).|Days 1 and 8|Pharmacokinetic analysis set representing a subset of participants from the Albuterol MDPI treatment arm.||hour||Standard Deviation|Mean
666994|NCT01747629|Secondary|Area Under the Concentration-time Curve From Time 0 (Pre-dose) to 24 Hours Post-dose(AUC0-24) for Albuterol on Day 8|Pharmacokinetic parameters of albuterol were determined on Day 1 after the first dose administration and at steady-state on Day 8. Day 1 serial (10-hr) blood samples for pharmacokinetics pre-dose (within 30 minutes prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5, 6, 8 and 10 hours (±10 minutes). Day 8 serial (6-hr) blood samples for pharmacokinetics pre-dose (within 30 min prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5 and 6 hr (±10 min).|Day 8|Pharmacokinetic analysis set representing a subset of participants from the Albuterol MDPI treatment arm.||pg*hr/mL||Standard Deviation|Mean
666995|NCT01747629|Secondary|Area Under the Concentration-time Curve From Time 0 (Pre-dose) to Infinity Post-dose(AUC0-inf) for Albuterol on Day 1|Pharmacokinetic parameters of albuterol were determined on Day 1 after the first dose administration and at steady-state on Day 8. Day 1 serial (10-hr) blood samples for pharmacokinetics pre-dose (within 30 minutes prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5, 6, 8 and 10 hours (±10 minutes). Day 8 serial (6-hr) blood samples for pharmacokinetics pre-dose (within 30 min prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5 and 6 hr (±10 min).|Day 1|Pharmacokinetic analysis set representing a subset of participants from the Albuterol MDPI treatment arm.||pg*hr/mL||Standard Deviation|Mean
666996|NCT01747629|Secondary|Area Under the Concentration-time Curve From Time 0 (Pre-dose) to Last Time of Quantifiable Concentration (AUC0-t) for Albuterol on Days 1 and 8|"Pharmacokinetic parameters of albuterol were determined on Day 1 after the first dose administration and at steady-state on Day 8. Day 1 serial (10-hr) blood samples for pharmacokinetics pre-dose (within 30 minutes prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5, 6, 8 and 10 hours (±10 minutes). Day 8 serial (6-hr) blood samples for pharmacokinetics pre-dose (within 30 min prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5 and 6 hr (±10 min).
AUC0-t on Day 8 is not from pre-dose but at steady state."|Days 1 and 8|Pharmacokinetic analysis set representing a subset of participants from the Albuterol MDPI treatment arm.||pg*hr/mL||Standard Deviation|Mean
666997|NCT01747629|Secondary|Area Under the Concentration-time Curve From Time 0 (Pre-dose) up to 6 Hours Post-dose (AUC0-6) for Albuterol on Days 1 and 8|"Pharmacokinetic parameters of albuterol were determined on Day 1 after the first dose administration and at steady-state on Day 8. Day 1 serial (10-hr) blood samples for pharmacokinetics pre-dose (within 30 minutes prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5, 6, 8 and 10 hours (±10 minutes). Day 8 serial (6-hr) blood samples for pharmacokinetics pre-dose (within 30 min prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5 and 6 hr (±10 min).
AUC0-6 on Day 8 is not from pre-dose but at steady state."|Days 1 and 8|Pharmacokinetic analysis set representing a subset of participants from the Albuterol MDPI treatment arm.||pg*hr/mL||Standard Deviation|Mean
666998|NCT01747629|Secondary|Time to Observed Peak Plasma Concentration (Tmax) for Albuterol on Days 1 and 8|Pharmacokinetic parameters of albuterol were determined on Day 1 after the first dose administration and at steady-state on Day 8. Day 1 serial (10-hr) blood samples for pharmacokinetics pre-dose (within 30 minutes prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5, 6, 8 and 10 hours (±10 minutes). Day 8 serial (6-hr) blood samples for pharmacokinetics pre-dose (within 30 min prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5 and 6 hr (±10 min).|Days 1 and 8|Pharmacokinetic analysis set representing a subset of participants from the Albuterol MDPI treatment arm.||hour||Full Range|Median
666999|NCT01747629|Secondary|Maximum Observed Plasma Drug Concentration (Cmax) for Albuterol on Days 1 and 8|Pharmacokinetic parameters of albuterol were determined on Day 1 after the first dose administration and at steady-state on Day 8. Day 1 serial (10-hr) blood samples for pharmacokinetics pre-dose (within 30 minutes prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5, 6, 8 and 10 hours (±10 minutes). Day 8 serial (6-hr) blood samples for pharmacokinetics pre-dose (within 30 min prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5 and 6 hr (±10 min).|Days 1 and 8|Pharmacokinetic analysis set representing a subset of participants from the Albuterol MDPI treatment arm.||pg/mL||Standard Deviation|Mean
667000|NCT01747629|Secondary|Participants With Clinically Significant Vital Sign Assessments|"For both standard and serial vital signs, participants were seated for at least 5 minutes before vital signs were assessed. Heart rate was obtained prior to the blood pressure measurement. Serial heart rate and blood pressure were conducted in the sitting position prior to the spirometry assessment; baseline measures were taken pre-dose at -30 ± 5 and -5 minutes on Day 1. Day 85 serial vital sign measures were taken in the sitting position prior to spirometry assessments pre-dose at -30 ± 5 and -5 minutes, then post-dose at 30 (±5) minutes, 1hr (± 10 min), 2hr (± 10 min), 3hr (± 10 min), 4hr (± 10 min), 5hr (± 10 min) and 6 hr (± 10 min).
Serial heart rate and blood pressure measurements that were elevated to the following criteria were considered clinically significant:
Systolic blood pressure: > 160 beats/minute Diastolic blood pressure: >100 beats/minute Heart rate: >120 beats/minute"|Days 8 and 85|Safety analysis set||participants|||Number
667001|NCT01747629|Secondary|Physical Examination Findings Shifts From Baseline to Endpoint by Treatment Group|Physical exam was recorded as normal or abnormal based on physician assessment. Format for results is: Test Baseline/Endpoint. HEENT = head, eyes, ears, nose, throat.|Day 1 (Baseline), Day 85|Safety population. Only participants with both baseline and endpoint physical examination findings are summarized.||participants|||Number
667122|NCT01744977|Primary|Cholesterol Medication Adherence|Pill refill obtained at 12 months to review change in cholesterol medication adherence over the 12 month period between groups|12 months|Data on pill refill could not be obtained for 2 of the education only participants.||adherence proportion||Inter-Quartile Range|Median
667002|NCT01747629|Secondary|Participants With Adverse Events|Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 to Day 93|Safety analysis set||participants|||Number
667003|NCT01747629|Secondary|Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 85|"FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. It represents the weighted average over six hours of the FEV1 AUC 0-6 measures adjusted for the baseline measure. The baseline was the average of the 2 pre-dose FEV1 measurements on that study day.
FEV1 was measured using spirometry. Spirometry assessments were obtained predose at -30 ± 5, and - 5 minutes, then post dose at 5 ± 2, 15 ± 5, 30 ± 5, 45 ± 5 minutes, and at 1hr ± 5 min, 2hr ± 5 min, 3hr ± 5 min, 4hr ± 5 min, 5hr ± 5 min, and 6hr ± 5 min."|Day 85|Full analysis set of participants with data at the time point||L*hr||95% Confidence Interval|Mean
667004|NCT01747629|Secondary|Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 8|"FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. It represents the weighted average over six hours of the FEV1 AUC 0-6 measures adjusted for the baseline measure. The baseline was the average of the 2 pre-dose FEV1 measurements on that study day.
FEV1 was measured using spirometry. Spirometry assessments were obtained predose at -30 ± 5, and - 5 minutes, then post dose at 5 ± 2, 15 ± 5, 30 ± 5, 45 ± 5 minutes, and at 1hr ± 5 min, 2hr ± 5 min, 3hr ± 5 min, 4hr ± 5 min, 5hr ± 5 min, and 6hr ± 5 min."|Day 8|Full analysis set of participants with data at the time point||L*hr||95% Confidence Interval|Mean
667005|NCT01747629|Secondary|Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 1|"FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. It represents the weighted average over six hours of the FEV1 AUC 0-6 measures adjusted for the baseline measure. The baseline was the average of the 2 pre-dose FEV1 measurements on that study day.
FEV1 was measured using spirometry. Spirometry assessments were obtained predose at -30 ± 5, and - 5 minutes, then post dose at 5 ± 2, 15 ± 5, 30 ± 5, 45 ± 5 minutes, and at 1hr ± 5 min, 2hr ± 5 min, 3hr ± 5 min, 4hr ± 5 min, 5hr ± 5 min, and 6hr ± 5 min."|Day 1|Full analysis set||L*hr||95% Confidence Interval|Mean
667006|NCT01747629|Primary|Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) Over the 12-week Treatment Period|"FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. It represents the weighted average (by the trapezoidal rule) over six hours of the FEV1 AUC 0-6 measures adjusted for the baseline measure (i.e., change from baseline at each timepoint) recorded on days 1, 8 and 85 of the treatment period. The baseline for each study day was the average of the 2 pre-dose FEV1 measurements on that study day.
FEV1 was measured using spirometry. Spirometry assessments were obtained predose at -30 ± 5, and - 5 minutes, then post dose at 5 ± 2, 15 ± 5, 30 ± 5, 45 ± 5 minutes, and at 1hr ± 5 min, 2hr ± 5 min, 3hr ± 5 min, 4hr ± 5 min, 5hr ± 5 min, and 6hr ± 5 min."|Day 1, Day 8 and Day 85|Full analysis set included all participants in the intent-to-treat population who received at least 1 dose of study medication and had at least 1 post-baseline assessment.||L*hr||Standard Error|Mean
667007|NCT01747343|Other Pre-specified|Change in the Mean Number of Self-initiations to Sit on the Toilet Across Children||2 months minus baseline|||Self-initiations||Standard Deviation|Mean
667008|NCT01747343|Secondary|Change in the Mean Percentage of Appropriate Eliminations Across Children||2 months minus baseline|||Percentage of opportunities||Standard Deviation|Mean
667009|NCT01747343|Primary|Change in the Mean Number of Accidents Across Children||2 months minus baseline|||Accidents||Standard Deviation|Mean
667010|NCT01747330|Secondary|Number of Participants With Clinical Relevant Safety Laboratory Values|(hematology: hemoglobin, hematocrit, RBC count, WBC count, platelet count; biochemistry: glucose (fasting), creatinine, alkaline phosphatase, total bilirubin, ALAT (alanine amino transferase), ASAT (aspartate amino transferase), gamma-glutamyl transferase, uric acid, calcium, phosphate, potassium, serum pancreatic lipase; urinalysis (dipstick): glucose, blood, albumin, pH)|3 months|Full Analysis subject sample||participants|||Number
667011|NCT01747330|Secondary|Number of Participants With Findings During Physical Examination|A physical examination was conducted by the physician. All abnormal findings were recorded as medical histories if present prior to start of study drug or as AEs otherwise. There was no separate documentation of physical examination findings in this study.|3 months|Full Analysis subject sample||participants|||Number
667012|NCT01747330|Secondary|Pulse|Change from Baseline at Day 84|3 months|||bpm||Standard Deviation|Mean
667013|NCT01747330|Secondary|Number of Subjects With Adverse Events||4 months|Full Analysis subject sample||participants|||Number
667014|NCT01747330|Primary|Subject's Acceptance of Treatment|Acceptance to Creon Micro. The caregiver should give his/her opinion based on the following scale: very good, good, moderate, and unsatisfactory.|3 months|Full Analysis subject sample||percentage of participants|||Number
667015|NCT01747330|Primary|Stool Consistency|Assessment of stool consistency by the caregiver on a daily basis: hard, formed/normal, soft, watery|3 months|Full Analysis subject sample||% of days with normal stool consistency||Standard Deviation|Mean
667016|NCT01747330|Primary|Stool Frequency|Average daily stool frequency during treatment period: Number of bowel movements per day|3 months|Full Analysis subject sample||Bowel movements per day||Standard Deviation|Mean
667017|NCT01747330|Primary|Height|change from baseline at day 84|3 months|Full Analysis subject sample||m||Standard Deviation|Mean
667018|NCT01747330|Primary|Body Weight|change from baseline at day 84|3 months|Full Analysis subject sample||kg||Standard Deviation|Mean
667121|NCT01744977|Secondary|Change in LDL Cholesterol Level as Measured at Baseline, 6months, 12months|obtain non-fasting lipid panel at timepoints to review change in LDL cholesterol levels over the 12 month period (at baseline, 6 and 12 months)|Baseline, 6months, 12months|Cholesterol values could not be obtained for all patients at all time points.||mg/dL||Standard Deviation|Mean
667019|NCT01746940|Primary|Immediate and Sustained Analgesic Success|The primary endpoint for this trial is analgesic success immediately after application of study drug and sustained throughout the diagnostic procedure or surgery for each nostril that received the study drug application. A subject will be considered a treatment success if they meet the following: Prior to the procedure or surgery, a 0 pain score on the 10 point pain scale (0=no pain, 10=unbearable pain) based on the Von Frey filament challenge after application of the assigned treatment solution (placebo, 4% or 10% Cocaine HCl). During the procedure or surgery, no further analgesic treatment is required (only 4% and 10% Cocaine HCl subjects who receive a procedure or surgery). Otherwise, the subject will be considered a treatment failure. Subjects with missing primary outcome data are marked as treatment failures in all treatment groups.|Prior to and During a one-day Surgery or Diagnostic Procedure|The analysis of primary outcome data is based on an intent-to-treat population, which includes all randomized subjects who received study drug and who are enrolled in the safety and efficacy phase of the study.||proportion of particpants analyzed||95% Confidence Interval|Number
667020|NCT01746862|Secondary|Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs|An adverse event (AE) was defined as any untoward medical occurrence which does not necessarily have a causal relationship with this the study drug. An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. For the Saizen Test Group, TEAEs were defined as events that occurred or worsened at or after the first administration of treatment and for the Saizen Control Group, TEAEs were defined as events that occurred or worsened at or after the randomization.|Baseline up to Month 13|Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.||subjects|||Number
667021|NCT01746862|Secondary|Percentage of Adherence to Study Treatment|Percentage of adherence to study treatment (adherence rate) was defined as the actual number of received treatments divided by the scheduled number of treatments multiplied by 100. The adherence rate for 6 months was calculated from Baseline to 6 months for the Saizen Test Group and from Month 6 to Month 12 for the Saizen Control Group.|6 months post-dose (Saizen Test Group and Saizen Control Group); 12 months post-dose (Saizen Test Group)|ITT analysis set included all randomized subjects, regardless of whether or not they received the treatment to which they were randomized, completed the study or had any protocol deviations. Here ”n” signifies those subjects who were evaluable for this outcome measure at the specified time points.||percentage of adherance||Standard Deviation|Mean
667022|NCT01746862|Secondary|Change From Baseline in Serum Concentration of Insulin Like Growth Factor Binding Protein-3 (IGFBP-3) at Month 6 and 12||Baseline, Month 6, Month 12|ITT analysis set included all randomized subjects, regardless of whether or not they received the treatment to which they were randomized, completed the study or had any protocol deviations. Here ”n” signifies those subjects who were evaluable for this outcome measure at the specified time points.||mcg/L||Standard Deviation|Mean
667023|NCT01746862|Secondary|Change From Baseline in Serum Concentration of Insulin-like Growth Factor-I (IGF-I) at Month 6 and 12||Baseline, Month 6, Month 12|ITT analysis set included all randomized subjects, regardless of whether or not they received the treatment to which they were randomized, completed the study or had any protocol deviations. Here ”n” signifies those subjects who were evaluable for this outcome measure at the specified time points.||microgram/liter (mcg/L)||Standard Deviation|Mean
667024|NCT01746862|Secondary|Change From Baseline in Height Standard Deviation Score (SDS) at Month 6 and 12|Height SDS was calculated as: Height SDS = (measured height – population mean) / population standard deviation, where mean and standard deviation were based on the Korean standard growth charts. SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) a subject’s value was relative to the mean of the reference population. The scores were centred around zero. Negative score indicated a subject was smaller for their age/gender.|Baseline, Month 6, Month 12|ITT analysis set included all randomized subjects, regardless of whether or not they received the treatment to which they were randomized, completed the study or had any protocol deviations. Here ”n” signifies those subjects who were evaluable for this outcome measure at the specified time points.||standard deviation score||Standard Deviation|Mean
667025|NCT01746862|Secondary|Change From Baseline in Height at Month 6 and 12||Baseline, Month 6, Month 12|ITT analysis set included all randomized subjects, regardless of whether or not they received the treatment to which they were randomized, completed the study or had any protocol deviations. Here ”n” signifies those subjects who were evaluable for this outcome measure at the specified time points.||centimeter (cm)||Standard Deviation|Mean
667026|NCT01746862|Secondary|Change From Baseline in Height Velocity at Month 12|Baseline height is defined as the last available height measurement before randomization. Baseline height velocity = ([Baseline height minus height measurement obtained at least 12 months prior] / 12) * 12. Height velocity at Month 12 = ([Month 12 height minus height measurement obtained at least 12 months prior] / 12) * 12.|Baseline, Month 12|ITT analysis set included all randomized subjects, regardless of whether or not they received the treatment to which they were randomized, completed the study or had any protocol deviations. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.||cm/year||Standard Deviation|Mean
667027|NCT01746862|Primary|Change From Baseline in Height Velocity at Month 6 Using Last Observation Carried Forward (LOCF) Method|Baseline height is defined as the last available height measurement before randomization. Baseline height velocity = ([Baseline height minus height measurement obtained at least 6 months prior] / 6) * 12. Height velocity at Month 6 = ([Month 6 height minus height measurement obtained at least 6 months prior] / 6) * 12.|Baseline, Month 6|Intent-to-treat (ITT) analysis set included all randomized subjects, regardless of whether or not they received the treatment to which they were randomized, completed the study or had any protocol deviations. Here ”n” signifies those subjects who were evaluable for this outcome measure at the specified time points.||centimeter/year (cm/yr)||Standard Deviation|Mean
667028|NCT01746784|Secondary|Change in Biomarkers of CFTR Function|Sweat chloride millequivalents/Liter (mEq/L)|Change from baseline at Day 7|Change from baseline sweat chloride (mEq/L) to Study Day 14||mEq/L||Standard Deviation|Mean
667033|NCT01746511|Secondary|Peak Total Serum Bilirubin Level|Bilirubin levels were checked every 12 hours while the infant was under phototherapy. A bilirubin level was then to be checked at least twice, 8-12 hours or longer apart, following discontinuation of phototherapy.|from time of enrollment to time of discharge every 12 hours while under phototherapy, for a maximum of 10 weeks|||mg/dL||Standard Deviation|Mean
667034|NCT01746511|Secondary|Number of Episodes of Repeat Phototherapy|"Bilirubin levels are checked at regular intervals after phototherapy is discontinued to make sure levels are safe. Depending on rate of rise and predetermined unsafe bilirubin level, phototherapy may be restarted."|from time of enrollment to time of discharge, for a maximum of 10 weeks|||episodes of repeat phototherapy||Full Range|Median
667035|NCT01746511|Primary|Total Number of Hours of Required Phototherapy||from time of enrollment to time of discharge, for a maximum of 10 weeks|||hours||Standard Deviation|Mean
667036|NCT01746368|Secondary|Satisfaction|"Score on the Client Satisfaction Questionnaire-8 (CSQ-8). The overall score is produced by summing all item responses. For the CSQ-8, scores range from 8 to 32, with higher values indicating higher satisfaction.
Response options differ from item to item, but all are based on a four-point scale.
All items are positively worded; however, the directionality of response options span the spectrum from very negative to very positive; and, the numerical anchors for items are reversed randomly (from high to low or low to high) from item to item to minimize stereotypic response sets. The CSQ-8 has no subscales and reports a single score measuring a single dimension of overall satisfaction."|For participants who received the allocated intervention, up to one month after intervention; for all others, up to 90 days after consenting to the study.|||Scores on a scale||Standard Deviation|Mean
667037|NCT01746368|Primary|Number of Participants Who Completed an Advance Directive|An advance directive was considered completed upon confirmation of the scanned document in the medical record.|Up to 1 month after intervention|intention to treat (ITT)||participants|||Number
667038|NCT01746264|Secondary|Reactive Hyperemia Index (RHI)|The cuff of a sphygmomanometer was placed on the forearm and inflated to 50 mm Hg above the participant’s systolic blood pressure for a period of 5 min. The increase in resting brachial blood flow was calculated as the maximum flow recorded in the first 15 seconds after cuff deflation and expressed as a percentage increase from baseline reactive. Higher values are considered normal or improved endothelial function.|baseline, 3 months|Data for one subject could not be included as the data on RHI was lost in the system and could not be retrieved.||percentage increase in blood flow||Standard Deviation|Mean
667039|NCT01746264|Secondary|Urine Calcium to Creatinine Ratio|Urine calcium/creatinine ratio (unit mg/g) on random urine sample was calculated by dividing calcium in mg by creatinine in g.|baseline, 3 months|||mg/g||Standard Deviation|Mean
667040|NCT01746264|Secondary|High Density Lipoprotein (HDL) Cholesterol Levels|Total HDL cholesterol levels were measured by an enzymatic colorimetric assay. The test for high-density lipoprotein cholesterol (HDL-C) is used along with other lipid tests to screen for unhealthy levels of lipids and to determine the risk of developing heart disease. If a subject has a negative risk factor, a desirable HDL level would be >/= 1.55 mmol/L.|baseline, 3 months|||mmol/L||Standard Deviation|Mean
667041|NCT01746264|Secondary|Low-density Lipoprotein Cholesterol (LDL) Cholesterol Levels|The test for low-density lipoprotein cholesterol is used as part of a lipid profile to predict an individual's risk of developing heart disease. A desirable level is <3.36 mmol/L; borderline high is 3.36 - 4.11 mmol/L; high is >/= 4.14 mmol/L. LDL cholesterol was calculated as: LDL = Total cholesterol - HDL cholesterol - Triglycerides/5.|baseline, 3 months|||mmol/L||Standard Deviation|Mean
667042|NCT01746264|Secondary|High Sensitivity C-reactive Protein (Hs-CRP)|A high-sensitivity C-reactive protein (hs-CRP) test may be used to help evaluate an individual for risk of cardiovascular disease (CVD). C-reactive protein (CRP) is a protein that increases in the blood with inflammation. Studies have suggested that a persistent low level of inflammation plays a major role in atherosclerosis, the narrowing of blood vessels due to build-up of cholesterol and other lipids, which is often associated with CVD. The hs-CRP test accurately measures low levels of C-reactive protein to identify low but persistent levels of inflammation and thus helps predict a person's risk of developing CVD. hs-CRP was measured using particle-enhanced immunonephelometry.|baseline, 3 months|||nmol/L||Standard Deviation|Mean
667043|NCT01746264|Secondary|Homeostatic Model Assessment of Insulin Resistance Index (HOMA-IR)|This calculation measures insulin resistance, and requires U.S. standard units. The healthy range is 0.5 to 1.4. Less than 1.0 means the subject is insulin-sensitive, which is optimal. Above 1.9 indicates early insulin resistance. Above 2.9 indicates significant insulin resistance. The HOMA-IR was calculated as: HOMA-IR = fasting serum glucose (mmol/L) x fasting insulin (mU/mL)/22.5.|baseline, 3 months|||index of beta cell function||Standard Deviation|Mean
667044|NCT01746264|Secondary|Fasting Insulin|Serum insulin was measured using commercial electrochemiluminescence immunoassay kits.|baseline, 3 months|||pmol/L||Standard Deviation|Mean
667045|NCT01746264|Secondary|Fasting Glucose|Plasma glucose was measured by hexokinase enzymatic assay.|baseline, 3 months|||mmol/L||Standard Deviation|Mean
667046|NCT01746264|Secondary|Serum Parathyroid Hormone (PTH)|A parathyroid hormone (PTH) blood test measures the level of parathyroid hormone in the blood. This test is used to help identify hyperparathyroidism, to find the cause of abnormal calcium levels, or to check the status of chronic kidney disease. PTH controls calcium and phosphorus levels in the blood. PTH was measured by a two-site chemiluminescent immunometric assay.|baseline, 3 months|||pmol/L||Standard Deviation|Mean
667047|NCT01746264|Secondary|Calcium Intake Per Day|Calcium intake was measured using the validated Short Calcium Questionnaire (SCQ). This questionnaire is in the form of an spreadsheet, and asks the participant to enter the number of servings per week of various food items and vitamin or mineral supplements. The spreadsheet calculates the daily calcium intake (mg/day) from the data entered.|baseline, 3 months|||mg/day||Standard Deviation|Mean
667059|NCT01746108|Secondary|Number of Subjects With Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of study subjects|From Dose 1 at Month 0 up to study end at Month 1 for primed subjects and at Month 3 for unprimed subjects.|The Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
667483|NCT01738698|Secondary|Change From Baseline in the Personal and Social Performance Scale (PSP) Score at 12 Weeks||Baseline and 12 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
667048|NCT01746264|Secondary|International Physical Activity Questionnaire (IPAQ) Short Form Score|The IPAQ short form used asked 7 questions about activities in the last 7 days, covering vigorous physical activities, moderate activities, walking, and sitting, asking for days per week, hours per day or minutes per day. The score is reported in metabolic equivalent (MET)-minutes per week. Possible scores could range from 0 (inactive) to greater than 3000 MET-minutes/week (highly active). The definition of high activity was vigorous intensity activity on at least 3 days achieving a minimum total activity of at least 1500 MET-minutes/week OR 7 days of any combination of walking, moderate-intensity or vigorous-intensity activities achieving a minimum total physical activity of at least 3000 MET-minutes/week. Therefore a score of > 3000 MET-minutes/week was possible.|baseline, 3 months|||MET-minutes per week||Standard Deviation|Mean
667049|NCT01746264|Secondary|Body Mass Index|Body Mass Index (BMI) is a health index for comparing weight to height. BMI is a person's weight in kilograms (kg) divided by his or her height in meters squared. The body mass index is an indication if a person is at a suitable weight for his height on an approximation of body fat. A body mass index of under 20 is considered to be underweight, while a body mass index between 20 to 25 is considered healthy. A body mass index in the range of 25 to 30 is regarded as overweight. A body mass index over 30 is regarded as obese.|baseline, 3 months|||kg/m^2||Standard Deviation|Mean
667050|NCT01746264|Secondary|Triglycerides|Total triglyceride levels were measured by an enzymatic colorimetric assay.|baseline, 3 months|||mmol/L||Standard Deviation|Mean
667051|NCT01746264|Secondary|Total Cholesterol|Total cholesterol levels were measured by an enzymatic colorimetric assay.|baseline, 3 months|||mmol/L||Standard Deviation|Mean
667052|NCT01746264|Secondary|25-hydroxy Vitamin D (25[OH]D) Levels|25(OH)D was measured using liquid chromatography-tandem mass spectrometry. Total 25(OH)D concentrations of each sample was calculated using internal standard, 25(OH)D_2 and 25(OH)D_3.|baseline, 3 months|||nmol/L||Standard Deviation|Mean
667053|NCT01746264|Primary|Flow Mediated Dilatation (FMD)|Endothelial function was assessed by FMD, via a high-resolution Doppler ultrasonography examination of the right brachial artery. FMD was calculated as the maximal percentage increase in brachial artery diameter (BAD) from baseline after the release of cuff occlusion.|baseline, 3 months|Data for one subject could not be included as the data on FMD was lost in the system and could not be retrieved.||percentage increase in BAD||Standard Deviation|Mean
667054|NCT01746173|Secondary|Induction Response|Induction response is the defined as the proportion of patients who achieve complete remission (CR) or partial remission (PR) during 6 cycles of induction therapy. Reponse was assessed was using a combination of CT scans and PET scans. Partial and complete response were categorized according to standard lymphoma response criteria, specifically the Revised Response Criteria (Cheson 2007). Given the cycle length of 3 weeks, induction duration per protocol was 18 weeks.|Disease was re-staged at cycles 3 and 6 during induction. Median duration of induction therapy in this study cohort was 6 cycles/18 weeks (range 2-6 cycles).|||proportion of patients||90% Confidence Interval|Number
667055|NCT01746173|Primary|24-month Progression-Free Survival Rate|24-month progression-free survival rate is defined as the proportion of patients remaining alive and progression-free at 24 months from start of induction therapy. Disease progression was assessed using a combination of CT scans and PET scans. Progression was categorized according to standard lymphoma response criteria, specifically the Revised Response Criteria (Cheson 2007).|Disease was re-staged at cycles 3 and 6 during induction, at day 100 post-ASCT, and in long-term follow-up at months 12, 18, 24 and 36. All patients were evaluable up to month 24.|The analysis dataset is comprised all enrolled patients.||proportion of patients||90% Confidence Interval|Number
667056|NCT01746108|Secondary|Concentrations of Antibodies Against Protein D (PD) in the Healthy Unprimed Group.|Anti-protein D (Anti-PD) antibody concentrations by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per millilitre (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 153 EL.U/mL. Antibody concentrations < 153 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|One month after Dose 1 (At Month 1) and one month after Dose 2 (At Month 3)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D for at least one blood sample taken after vaccination.||EL.U/mL||95% Confidence Interval|Geometric Mean
667057|NCT01746108|Secondary|Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes in the Healthy Un-primed Group.|Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F and were calculated, expressed as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation. When number of subjects analysed = 1, Lower limit and Upper Limit values were entered as equal to the Geometric mean value. “999999.9” was used as placeholder when Upper Limit value was greater than “1.0E8”.|One month after Dose 1 (At Month 1) and/or one month after Dose 2 (At Month 3)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D for at least one blood sample taken after vaccination.||Titers||95% Confidence Interval|Geometric Mean
667058|NCT01746108|Secondary|Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes in the Healthy Un-primed Group.|"Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F-inhibition enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per millilitre (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.
Antibody concentrations < 0.05 μg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation."|One month after Dose 1 (At Month 1) and one month after Dose 2 (At Month 3)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D for at least one blood sample taken after vaccination.||EL.U/mL||95% Confidence Interval|Geometric Mean
667098|NCT01745380|Secondary|Number of Participants With a Decrease From Baseline in Diastolic Blood Pressure Greater Than or Equal to 10 mm Hg and/or to a Value Lower Than 50 mm Hg||at any time within 120 minutes following study drug administration|||participants|||Number
667060|NCT01746108|Secondary|Number of Subjects With Unsolicited AEs.|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within the 31-day (Days 0-30) post- vaccination period|The Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
667061|NCT01746108|Secondary|Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs) After Dose 2 for Subjects Aged Between 5 to 17 Years.|General AEs = headache, fatigue, gastrointestinal symptoms (gastro symp) (nausea, vomiting, diarrhoea and/or abdominal pain) and fever (axillary ≥ 37.5 degrees Celsius). Any= Incidence of any solicited general symptom regardless of intensity grade or relationship to vaccination. Grade 3: headache, fatigue and gastrointestinal symptoms = symptoms that prevented normal activity; Fever > 39.5°C. Related = symptom assessed by the investigator as related to the vaccination. Primed subjects received one dose and Unprimed subjects received two doses.|During the 4-day (Days 0-3) after dose 2|The Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
667062|NCT01746108|Secondary|Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs) After Dose 1 for Subjects Aged Between 5 to 17 Years.|General AEs = headache, fatigue, gastrointestinal symptoms (gastro symp) (nausea, vomiting, diarrhoea and/or abdominal pain) and fever (axillary ≥ 37.5 degrees Celsius). Any= Incidence of any solicited general symptom regardless of intensity grade or relationship to vaccination. Grade 3: headache, fatigue and gastrointestinal symptoms = symptoms that prevented normal activity; Fever > 39.5°C. Related = symptom assessed by the investigator as related to the vaccination. Primed subjects received one dose and Unprimed subjects received two doses.|During the 4-day (Days 0-3) after dose 1|The Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
667063|NCT01746108|Secondary|Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs) After Dose 2 for Subjects Aged Between 2 to 4 Years.|General AEs = drowsiness, irritability, loss of appetite (loss of appet) and fever (axillary ≥ 37.5 degrees Celsius). Any= Incidence of any solicited general symptom regardless of intensity grade or relationship to vaccination. Grade 3: drowsiness = prevented normal activity; irritability = crying that could not be comforted/ prevented normal activity; loss of appetite = not eating at all; fever > 39.5°C. Related = symptom assessed by the investigator as related to the vaccination. Primed subjects received one dose and Unprimed subjects received two doses.|During the 4-day (Days 0-3) after dose 2|The Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
667064|NCT01746108|Secondary|Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs) After Dose 1 for Subjects Aged Between 2 to 4 Years.|General AEs = drowsiness, irritability, loss of appetite (loss of appet) and fever (axillary ≥ 37.5 degrees Celsius). Any= Incidence of any solicited general symptom regardless of intensity grade or relationship to vaccination. Grade 3: drowsiness = prevented normal activity; irritability = crying that could not be comforted/ prevented normal activity; loss of appetite = not eating at all; fever > 39.5°C. Related = symptom assessed by the investigator as related to the vaccination. Primed subjects received one dose and Unprimed subjects received two doses.|During the 4-day (Days 0-3) after dose 1|The Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
667065|NCT01746108|Secondary|Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs) After Dose 2 for Subjects Aged Between 5 to 17 Years.|Solicited local AEs assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain = Significant pain at rest. Prevented normal every day activities. Grade 3 redness/swelling = redness/swelling above 50 millimetre. Primed subjects received one dose and Unprimed subjects received two doses.|During the 4-day (Days 0-3) after dose 2|The Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
667066|NCT01746108|Secondary|Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs) After Dose 1 for Subjects Aged Between 5 to 17 Years.|Solicited local AEs assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain =Significant pain at rest. Prevented normal every day activities. Grade 3 redness/swelling = redness/swelling above 50 millimetre. Primed subjects received one dose and Unprimed subjects received two doses.|During the 4-day (Days 0-3) after dose 1|The Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
667067|NCT01746108|Secondary|Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs) After Dose 2 for Subjects Aged Between 2 to 4 Years.|Solicited local AEs assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimetre. Primed subjects received one dose and Unprimed subjects received two doses.|During the 4-day (Days 0-3) after dose 2|The Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
667068|NCT01746108|Secondary|Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs) After Dose 1 for Subjects Aged Between 2 to 4 Years.|Solicited local AEs assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimetre. Primed subjects received one dose and Unprimed subjects received two doses.|During the 4-day (Days 0-3) after dose 1|The Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
667069|NCT01746108|Primary|Concentrations of Antibodies Against Protein D (PD) in the At Risk Unprimed Group.|Anti-protein D (Anti-PD) antibody concentrations by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per millilitre (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 153 EL.U/mL. Antibody concentrations < 153 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|One month after Dose 1 (At Month 1) and one month after Dose 2 (At Month 3)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D for at least one blood sample taken after vaccination.||EL.U/mL||95% Confidence Interval|Geometric Mean
668252|NCT01729026|Secondary|Alcohol Use Disorders Identification Test (AUDIT-C)|Self-rating scale that assesses the frequency and extent of alcohol use|Baseline and 1-month, 3-month, 4-month, and 6-month follow-ups||||||
667070|NCT01746108|Primary|Concentrations of Antibodies Against Protein D (PD) in the At Risk Primed Group.|Anti-protein D (Anti-PD) antibody concentrations by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per millilitre (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 153 EL.U/mL. Antibody concentrations < 153 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|One month after Dose 1 (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D for at least one blood sample taken after vaccination.||EL.U/mL||95% Confidence Interval|Geometric Mean
667071|NCT01746108|Primary|Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes in the At Risk Un-primed Group.|"Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F and were calculated, expressed as geometric mean titers (GMTs). The seropositivity cut-off for the assay was
≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation."|One month after Dose 1 (At Month 1) and one month after Dose 2 (At Month 3)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D for at least one blood sample taken after vaccination.||Titers||95% Confidence Interval|Geometric Mean
667072|NCT01746108|Primary|Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes in the At Risk Primed Group.|"Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F and were calculated, expressed as geometric mean titers (GMTs). The seropositivity cut-off for the assay was
≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation."|One month after Dose 1 (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D for at least one blood sample taken after vaccination.||Titers||95% Confidence Interval|Geometric Mean
667073|NCT01746108|Primary|Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes in the At Risk Un-primed Group.|"Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A,
-19F and -23F). Antibody concentrations were measured by 22F-inhibition enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per millilitre (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.
Antibody concentrations < 0.05 μg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation."|One month after Dose 1 (At Month 1) and one month after Dose 2 (At Month 3)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D for at least one blood sample taken after vaccination.||μg/mL||95% Confidence Interval|Geometric Mean
667074|NCT01746108|Primary|Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes in the At Risk Primed Group.|"Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F-inhibition enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per millilitre (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.
Antibody concentrations < 0.05 μg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation."|One month after Dose 1 (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D for at least one blood sample taken after vaccination.||μg/mL||95% Confidence Interval|Geometric Mean
667075|NCT01745952|Other Pre-specified|Adverse Event Rate||during the 9 months of the study|||participants|||Number
667076|NCT01745952|Other Pre-specified|Drop Out-rate|exclusion by investigator was due to necessity to change drug regimen due to toxicity|during the 9 months of the study|for this analysis, all patients randomised were included; this includes one patient in the second arm that was not included in any of the other outcome measures, due to lack of reliable outcome parameters||participants|||Number
667077|NCT01745952|Other Pre-specified|Questionnaires: Quality of Life in Epilepsy (QOLIE-31), Global Impression of Change-scales, Visual Analogue Scale, Columbia Suicide Severity Rating Scale|"Quality of life in epilepsy (QOLIE-31): self-report (if cognitive faculties allowed) questionnaire of emotional well-being, social functioning, energy/ fatigue, cognitive functioning, seizure worry, medication effects & overall quality of life. Range 0-100, with higher numbers indicating better quality of life.
Global impression of change-scales (score 1-7, with 4 no change and lower/higher numbers implying grade of improvement/worsening) and Visual analogue scale (0-10: no problem to horrible): self-report or parent report about effect of treatment
Columbia Suicide Severity Rating Scale (CSSR): structured interview about suicidal risk
change in QOLIE scores considered better/worse are based on cut-off reported in DOI 10.1016/j.yebeh.2011.12.023 For global impression of change, the scoring was <4, 4 or >4."|before the first treatment of each session and at the last evaluation visit|* Self-reporting questionnaires could only be filled in by 7 participants For global impression of change scales, the score reached by consensus between the patient and caregiver(s) was used if patient was unable to fill in questionaires: for the three arms, we thus have 7/8/6 scores for each arm respectively||participants|||Number
667078|NCT01745952|Other Pre-specified|Difference in Seizure Reduction Using Different Coil Types|any difference between the four conditions (baseline/ figure-of-eight treatment/ round coil treatment/ sham treatment) based in negative binomial model for count data|9 months|averaged weekly seizure count per condition is given for all patients combined||number of seizures per week||95% Confidence Interval|Mean
667099|NCT01745380|Secondary|Number of Participants With an Increase From Baseline in Diastolic Blood Pressure Greater Than or Equal to 15 mm Hg and/or to a Value Higher Than 105 mm Hg||at any time within 120 minutes following study drug administration|||participants|||Number
667100|NCT01745380|Secondary|Number of Participants With a Decrease From Baseline in Systolic Blood Pressure Greater Than or Equal to 15 mm Hg and/or to a Value Lower Than 90 mm Hg||at any time within 120 minutes following study drug administration|||participants|||Number
667079|NCT01745952|Other Pre-specified|Alteration of Brain Activation as Measured by 18-2-fluoro-2-deoxy-D-glucose Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) on Individual Patient Level|Alterations were assessed by visual inspection of PET scans generated by subtracting the baseline individual PET scan from each of the follow-up scans. The subtraction PET scans were overlayed on the anatomical MRI of the patient and the focus of stimulation determined and an sphere with a 1cm radius around this point was analysed.|within one week after the last treatment day of each session|"patients of whom seizure journals were incomplete also included (one participant who went through all 3 trials and one patient of whom journals were not available from the sham session, that was reported by the patient as ineffective)"||participants|||Number
667080|NCT01745952|Secondary|Percentage of Seizure Reduction After Active rTMS Treatment Compared With Placebo Treatment|Seizure frequency was recorded in patient diaries and reviewed with the neurologist/epileptologist (outcomes assessor) at visits 12 weeks (+/- 1 week) after each intervention. The average weekly seizure rate was calculated and compared to baseline frequency over all participants.|week 12 after each treatment|baseline weekly seizure frequency over all participants was 24.8 (95% confidence interval 8.2-76.1)||seizures/week||95% Confidence Interval|Mean
667081|NCT01745952|Primary|50% Responder Rate After Active rTMS Treatment Compared With Placebo Treatment|Number of participants achieving a 50% or greater reduction in seizure frequency from baseline|week 12 after each intervention|||participants|Participants||Number
667082|NCT01745913|Secondary|Severity of Opportunistic Infections||estimation of 24 months to obtain infection data on all subjects||||||
667083|NCT01745913|Secondary|Incidence of Acute and Chronic GVHD||estimation of 24 months to obtain GVHD data on all subjects||||||
667084|NCT01745913|Secondary|Transplant-related Mortality (TRM), Relapse Rate, Survival and Progression Free Survival||estimation of 24 months to obtain survival info between subjects||||||
667085|NCT01745913|Secondary|Transfusion Requirements After Haplo-identical Umbilical Cord Blood Transplant Versus Double Umbilical Cord Blood Transplant||estimation of 24 months to determine transfusion requirements of all subjects||||||
667086|NCT01745913|Secondary|Platelet Recovery After Transplant Regimens|No patients completed this study and are therefore inevaluable|estimation of 24 months to determine platelet recovery for all subjects|Data not collected. Patients died.|||||
667087|NCT01745913|Primary|Rate of Neutrophil Engraftment After Combined Haplo-identical Cord With That of Umbilical Cord Blood Transplantation.|No patients completed this study and are therefore inevaluable. Subject data not evaluable for the outcome measure time frame. Subject data only evaluable up to month 3.|estimation of 24 months to determine engraftment rates for all subjects|Data not collected. Patients died.|||||
667088|NCT01745848|Secondary|Absolute Change From Baseline of Measurements of Brachial Artery Flow Mediated Dilation|Participants had flow mediated dilation of the brachial artery measured at the baseline visit and at the follow-up visit after receiving 30 days of roflumilast 500 mcg daily. An ultrasound probe was placed over the brachial artery and the brachial artery diameter was measured in real time. A blood pressure cuff positioned below the elbow was then inflated to 50 mmHg above systolic pressure for five minutes. After five minutes of occlusion, the blood pressure cuff was released and the brachial artery diameter was again measured in real time. The amount of dilation expressed as the absolute change, in millimeters, from baseline diameter was quantified using the ultrasound images obtained 60 seconds after cuff release.|30 days - measured at baseline and 30 days|Data were analyzed for the 20 participants completing baseline and follow-up visits after one month on study drug.||millimeters||Standard Deviation|Mean
667089|NCT01745848|Primary|Change From Baseline of Systemic Markers of Bone Metabolism (C-terminal Peptide of Type 1 Collagen (CTx) and Amino-terminal Propeptide of Type-1 Procollagen (P1NP))|Serum samples were obtained at baseline and after participants took a once daily, 500 mcg roflumilast dose for 30 days. Samples were obtained in the semi-fasting state, processed, and stored for batch analysis at the end of the study. C-terminal peptide of type 1 collagen (CTx), a marker of bone resorption, was analyzed using a commercially available immunoassay (Roche Elecsys 2010 analyzer, Roche Diagnostics, Manheim, Germany). Serum amino-terminal propeptide of type-1 procollagen (P1NP) was measured by ELISA (MyBioSource, San Diego, CA). All assays were performed according to the manufacturers’ instructions.|30 days - measurements at baseline and 30 days|Data were analyzed for the 20 participants completing baseline and follow-up visits after one month on study drug.||ng/mL||Standard Deviation|Mean
667090|NCT01745380|Other Pre-specified|Number of Participants Who Received Three Sprays and Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic.|A participant will receive two sprays and Study Dental Procedure will begin. If the participant does not have sufficient anesthesia a third sprays will be given. If after the third spray, the participant does not have sufficient anesthesia to complete the Study Dental Procedure, the participant is given a rescue injection of local anesthetic. This outcome analyzes just the participants who received the third spray and whether or not they completed the Study Dental Procedure without need for rescue by injection of local anesthesia.|at 25 minutes, +3 minute window|This analysis is only of the participants who received 3 sprays. It does not include participants who only received 2 sprays.||participants|||Number
667091|NCT01745380|Secondary|The Profile Over Time of Diastolic Blood Pressure||from baseline to 120 minutes following drug administration|||mmHg||Standard Deviation|Mean
667092|NCT01745380|Secondary|The Profile Over Time of Systolic Blood Pressure||from baseline to 120 minutes following drug administration|||mmHg||Standard Deviation|Mean
667093|NCT01745380|Secondary|Alcohol Sniff Test|The change from screening in the the distance from the nose (in centimeters) that a patient is able to detect the smell of alcohol on a cotton ball.|administered at approximately 24 hours after drug administration|||cm||Standard Deviation|Mean
667094|NCT01745380|Secondary|The Profile Over Time of Heart Rate||from baseline to 120 minutes following drug administration|||beats per minute||Standard Deviation|Mean
667095|NCT01745380|Secondary|Maximum Change From Baseline in Diastolic Blood Pressure||from baseline to 120 minutes following drug administration|||mmHg||Standard Deviation|Mean
667096|NCT01745380|Secondary|Maximum Change From Baseline in Systolic Blood Pressure||from baseline to 120 minutes following drug administration|||mmHg||Standard Deviation|Mean
667097|NCT01745380|Secondary|Maximum Change From Baseline in Heart Rate||from baseline to 120 minutes following drug administration|||bpm||Standard Deviation|Mean
667104|NCT01745380|Secondary|Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic by Age Group (≤50 and >50 Years)|If the participant does not have sufficient anesthesia to complete the Study Dental Procedure, the participant is given a rescue injection of local anesthetic and is considered a failure for this outcome. This outcome is broken down by age group, 1) less than 50 years of age and 2) 50 years of age and older.|at 15 minutes (+3 minute window) or 25 minutes (+3 minute window) if third intranasal spray is used|Participants were only analyzed in their corresponding age group.||percentage of participants|||Number
667105|NCT01745380|Primary|Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic.|If the participant does not have sufficient anesthesia to complete the Study Dental Procedure, the participant is given a rescue injection of local anesthetic and is considered a failure for this outcome.|at 15 minutes, +3 minute window|||participants|||Number
667106|NCT01745133|Primary|Physician Global Assessement|"Percentage of participants with clear or almost clear skin on the PGA scale. 0 = clear
= almost clear
= mild
= moderate
= severe"|10 weeks|||percentage of patients|||Number
667107|NCT01745055|Secondary|Renal Clearance (CL R) for Methotrexate (MTX)||0 (pre-dose) through 24 hours post-dose on Day 1 and Day 7|PK analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence.||L/hr||Standard Deviation|Mean
667108|NCT01745055|Secondary|Total Amount of Unchanged Drug Excreted in the Urine From Time Zero to 24 Hours (Ae[0-24]) for Methotrexate (MTX)||0 (pre-dose) through 24 hours post-dose on Day 1 and Day 7|PK analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence.||milligram||Standard Deviation|Mean
667109|NCT01745055|Secondary|Renal Clearance (CL R) for CP-690,550||0 (pre-dose) through 24 hours post-dose on Day 6 and Day 7|PK analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence.||litre/hour (L/hr)||Standard Deviation|Mean
667110|NCT01745055|Secondary|Total Amount of Unchanged Drug Excreted in the Urine From Time Zero to 12 Hours (Ae[0-12]) for CP-690,550||0 (pre-dose) through 12 hours post-dose on Day 6 and Day 7|PK analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence.||milligram||Standard Deviation|Mean
667111|NCT01745055|Secondary|Apparent Oral Clearance (CL/F) for Methotrexate (MTX)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 , 12, 24 and 48 hours post-dose on Day 1 and Day 7|PK analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence.||mL/hr||Standard Deviation|Mean
667112|NCT01745055|Secondary|Plasma Decay Half-Life (t1/2) for Methotrexate (MTX)|Plasma decay half-life is the time measured for the plasma concentration of MTX to decrease by one half.|0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 , 12, 24 and 48 hours post-dose on Day 1 and Day 7|PK analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence.||hour||Standard Deviation|Mean
667113|NCT01745055|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) for Methotrexate (MTX)||0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 ,12, 24 and 48 hours post-dose on Day 1 and Day 7|PK analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence.||hour||Full Range|Median
667114|NCT01745055|Secondary|Apparent Oral Clearance (CL/F) for CP-690,550|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8 and 12 hours post-dose on Day 6 and Day 7|PK analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence.||mL/hr||Standard Deviation|Mean
667115|NCT01745055|Secondary|Plasma Decay Half-Life (t1/2) for CP-690,550|Plasma decay half-life is the time measured for the plasma concentration of CP-690,550 to decrease by one half.|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8 and 12 hours post-dose on Day 6 and Day 7|PK analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence.||hour||Standard Deviation|Mean
667116|NCT01745055|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) for CP-690,550||0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8 and 12 hours post-dose on Day 6 and Day 7|PK analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence.||hour||Full Range|Median
667117|NCT01745055|Primary|Maximum Observed Plasma Concentration (Cmax) for Methotrexate (MTX)||0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, 24 and 48 hours post-dose on Day 1 and Day 7|PK analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence.||ng/mL||Standard Deviation|Mean
667118|NCT01745055|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Methotrexate (MTX)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).|0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours post-dose on Day 1 and Day 7|PK analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence.||ng*hr/mL||Standard Deviation|Mean
667119|NCT01745055|Primary|Maximum Observed Plasma Concentration (Cmax) for CP-690,550||0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8 and 12 hours post-dose on Day 6 and Day 7|The PK analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence.||ng/mL||Standard Deviation|Mean
667120|NCT01745055|Primary|Area Under the Curve From Time Zero to 12 Hours [AUC (0-12)] for CP-690,550|AUC (0-12)= area under the plasma concentration time-curve from time zero (pre-dose) to 12 hours (0-12).|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8 and 12 hours post-dose on Day 6 and Day 7|The pharmacokinetic (PK) analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence.||nanogram*hour/milliliter (ng*hr/mL)||Standard Deviation|Mean
667123|NCT01744860|Secondary|Management of Discordance-Final Result for BRAF V600 Mutation Detection|The final results obtained by discordance management of the 28 discordant samples were BRAF V600 mutation, No BRAF V600 mutation and Non-evaluable. These results were further assessed by the Investigator and interpreted as final result.|Up to 6 months|"The discordant sample population is defined as the samples whose result for BRAF V600 mutation by the in-house method did not show similar outcome with the cobas 4800 mutation test."||number of samples|Participants||Number
667124|NCT01744860|Secondary|Management of Discordance- Method Used to Manage Discordance|"Crossing DNA, DNA from In-House method analysed with cobas, SNaPshot, DNA from cobas analysed with In-House method, external site control test, Sanger sequencing, Kit CE-IVD Therascreen RGQ Qiagen, Kit Therascreen RGQ BRAF + Pyrosequencing by another platform (PF), Pyrosequencing, Mutation detection On Another Block, (primitive tumor [prm. tmr]), Sequencing And Therascreen kit (Qiagen) were used for management of discordance between in-house method and Cobas 4800 mutation test."|Up to 6 months|"The discordant sample population is defined as the samples whose result for BRAF V600 mutation by the in-house method did not show similar outcome with the cobas 4800 mutation test."||number of samples|Participants||Number
667125|NCT01744860|Secondary|Technician Work Time Between DNA Extraction and Result by Cobas 4800 BRAF V600 Mutation Test - Analytical Method|This cobas 4800 BRAF V600 Mutation Test analytical method measures the working time required by the technician from the time of DNA extraction to the time to obtain the results. The time duration was measured in hours.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.||hours|Participants|Full Range|Median
667126|NCT01744860|Secondary|Median Time Between Receipt of Sample and Determination of Result by Cobas 4800 BRAF V600 Mutation Test -Analytical Method|This analytical method for cobas 4800 BRAF V600 Mutation Test measured the time between receipt of samples to the result determination. It measured the time in days.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.||days|Participants|Full Range|Median
667127|NCT01744860|Secondary|Number of Slices Used When No Punch Was Used for Cobas 4800 BRAF V600 Mutation Test- Analytical Method|This describes the Cobas 4800 BRAF V600 Mutation Test, for the mean of number of slices when No punch method, was used. Of the 420 samples, punch was Yes, for 45 samples and punch was No, for 375 samples.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis. Data for the samples where the punch was No=375, was used for analysis.||number of samples|Participants|Standard Deviation|Mean
667128|NCT01744860|Secondary|Punch Used for Cobas 4800 BRAF V600 Mutation Test- Analytical Method|The punch done during Cobas 4800 BRAF V600 Mutation Test on the sample was described as Yes or No.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.||number of samples|Participants||Number
667129|NCT01744860|Secondary|Mean DNA Concentration as Measured by COBAS 4800 BRAF V600 Mutation Test-Analytical Method|The DNA concentration as assessed by COBAS 4800 BRAF V600 Mutation assay was reported. The unit used to measure the DNA concentration was nanogram/microlitre (ng/mcl)|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.||ng/mcl|Participants|Standard Deviation|Mean
667130|NCT01744860|Secondary|Technician Work Time Between DNA Extraction and Result by “In-house” Analytical Method|The working time required by the technician from the time of DNA extraction to the time to obtain the results was measured in hours.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.||hours|Participants|Full Range|Median
667131|NCT01744860|Secondary|Median Time Between Receipt of Samples and Determination of Result by “In-house” Analytical Method|This In-house analytical method measured the time between receipt of samples to the result determination. It measured the time in days.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.||days|Participants|Full Range|Median
667132|NCT01744860|Secondary|Mean Number of Slices Per Sample Used for “In-house”- Analytical Method|The mean of number of slices per sample when no punch was used are reported.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis. Data for the samples where the punch was not used were considered for analysis.||number of samples|Participants|Standard Deviation|Mean
667133|NCT01744860|Secondary|Number of Samples Punched in In-house Analytical Method|Total number of samples for whom punch was used in 'in-house analytical' method are reported.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.||number of samples|Participants||Number
667134|NCT01744860|Secondary|Method of Mutation Detection by “In-house” Analytical Method|Allele-specific PCR, High Resolution Melting (HRM) + Sanger sequencing, Pyrosequencing, Sanger sequencing, Real time PCR, SNaPshot were used for BRAF V600 mutation detection.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.||number of samples|Participants||Number
667135|NCT01744860|Secondary|Size of Amplicons Used by “In-house” Analytical Method|The method described the size of amplicon used. It was measured in base pairs (bp).|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.||bp|Participants|Full Range|Median
667136|NCT01744860|Secondary|Amount of DNA by Pre-analytical Method|The total DNA concentration extracted from the tissue was measured in nanogram (ng).|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.||ng|Participants|Standard Deviation|Mean
667137|NCT01744860|Secondary|Mean DNA Concentration by Pre-analytical Method|The DNA concentration in the tissue elute was measured in nanogram per microliter (ng/mcL).|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.||ng/mcl|Participants|Standard Deviation|Mean
667138|NCT01744860|Secondary|Median DNA Elution Volume by Pre-analytical Method|Median DNA elution volume microliters [mcl] was reported.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.||mcl|Participants|Full Range|Median
667139|NCT01744860|Secondary|DNA Extraction – Extraction Method by Pre-analytical Method|This method assessed DNA from the tumor samples was extracted by Automated method or Manual method.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.||number of samples|Participants||Number
667140|NCT01744860|Secondary|Tumor Samples With Presence of Melanin by Pre-analytical Method|The tumor samples with presence of melanin were categorized as Important, Few, Medium and Absent.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis. Only available samples were included for analysis.||number of samples|Participants||Number
667141|NCT01744860|Secondary|Percentage of Tumor Cells by Pre-analytical Method|The percentage of tumor cells in the given tumor sample were reported.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.||percentage|Participants|Standard Deviation|Mean
667142|NCT01744860|Secondary|Necrosis Percentage Determination by Pre-analytical Method|The percentage of necrosis defined as the death of one or more cells in the analysed zone was reported.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis. Only 341 samples out of 420 were analysed as the information on presence of necrosis was missing for 79 samples in the assessed zones.||percentage|Participants|Standard Deviation|Mean
667143|NCT01744860|Secondary|Dewaxing by Pre-analytical Method|Dewaxing is a method to recover the DNA from samples. Dewaxing information was collected as “Yes, No or Missing”|Up to 6 Months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.||number of samples|Participants||Number
667144|NCT01744860|Secondary|Slice Thickness by Pre-analytical Method|Slice thickness of all the tumour samples was measured. The slice thickness was measured in micrometer.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.||micrometer (µm)|Participants|Standard Deviation|Mean
667145|NCT01744860|Secondary|Fixation Duration by Pre-analytical Method|Fixation duration is defined as the amount of time required in hours for the fixation of a samples. The fixation duration was categorized as <6 hours, 6-24 hours and >24 hours and unknown. Number of samples falling in each category were reported|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.||number of samples|Participants||Number
667146|NCT01744860|Secondary|Type of Fixative Used- Pre-analytical Method|The different types of fixative Excell, formol, alcohol formol acetic acid and other, used to fix the tumor samples were reported.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.||number of samples|Participants||Number
667147|NCT01744860|Secondary|Time From Sampling to Fixation- Pre-analytical Method|Time taken from the sampling to the fixation of the tumor sample was reported in range of 0-2 hours, 2-6 hours, >6 hours and unknown. Number of samples falling in each of the class were reported.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.||number of samples|Participants||Number
667148|NCT01744860|Secondary|Type of Pathology Laboratory Performing the Fixation or Embedding-Pre-analytical Method|The external or internal pathology laboratories involved in the process of fixation or embedding of the tumor sample was evaluated.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.||number of samples|Participants||Number
667149|NCT01744860|Secondary|Tumor Sample Characteristics - Source of Tumor Sample|The source of tumor sample for BRAF V600 mutation detection whether taken from internal or external pathology laboratory were reported|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.||number of samples|Participants||Number
667150|NCT01744860|Secondary|Tumor Sample Characteristics-Type of Tumor Sample|The type of tumor sample used for evaluation of BRAF V600 mutation whether it was a biopsy or surgical specimen were reported|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis||number of samples|Participants||Number
667151|NCT01744860|Primary|BRAF Mutation Status According to Cobas 4800 BRAF V600 Mutation Test vs. INCa Laboratories Molecular Genetics Laboratories|"BRAF V600 mutation status was determined by INCa molecular laboratories “in-house” methods and Cobas 4800 BRAF V600 mutation test. Samples were analysed as V600 mutation, No V600 mutation and Non evaluable. Additionally, the type of V600 mutation (E, K, R, D, E2, other V600 mutation, not specified) was also evaluated only by INCa molecular laboratory in-house method."|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis. n = number of samples with BRAF V600 mutation by “in-house method”.||number of samples|Participants||Number
667152|NCT01744821|Secondary|Review of the Differences in the Types and Incidence of Toxicities Associated With Vitamin D3 Replacement.|Differences in the types and incidence of toxicities associated with Vitamin D3 replacement, specifically hypercalcemia, with increasing levels of Vitamin D3 along with the effectiveness of Vitamin D3 supplementation on increasing serum levels of Vitamin D|Up to 24 months|||participants|||Number
667153|NCT01744821|Secondary|Review of Standard Pathologic Evaluation With Specific Attention to Histologic Markers|"The outcomes that will be measured for the secondary objectives of this study will include the following:
Review of standard pathologic evaluation with specific attention to histologic markers including serous hyperplasia, tubal atypia, and p53 signature in the ovary and fallopian tube, and examine via immunohistochemistry the effects of vitamin D supplementation on expression of the TGF-beta isoforms and CYP24"|Up to 24 months|We failed to accrue enough patients in order to conduct this outcome measure. We collected the specimens but were unable to analyze them given the low accrual numbers.|||||
667154|NCT01744821|Primary|Other Surrogate Endpoint Biomarkers Markers of Cancer Prevention|Decrease in cellular proliferation measured by immunohistochemistry staining with KI67|Up to 24 months|We failed to accrue enough patients in order to conduct this outcome measure. We collected the specimens but were unable to analyze them given the low accrual numbers.|||||
667155|NCT01744821|Primary|The Outcomes That Will be Measured for the Primary Objectives of This Study Will be Surrogate Endpoint Biomarkers Markers of Cancer Prevention|Activation of apoptosis via immunohistochemical measurement of activation of caspase activity, as well as expression of BAX and BCL-2 The primary marker outcomes will be assessed for normality and compared between groups using a two-sample t-test or a Wilcoxon rank sum test. Other markers will be compared similarly if continuous, or by Fisher's exact test if categorical.|Up to 24 months|We failed to accrue enough patients in order to conduct this outcome measure. We collected the specimens but were unable to analyze them given the low accrual numbers.|||||
667156|NCT01744730|Primary|PK - Volume of Distribution (V) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin.|"In order to understand the impact of obesity on clindamycin PK, PK data were combined to build a PK model from 3 studies that included both obese & non-obese children: 1) PTN_Clinda Obese study (clinicaltrials.gov/ct.gov identifier NCT01744730) n = 21; 2) PTN_POPS study (ct.gov identifier NCT01431326) n = 178; and 3) Staph Trio study (ct.gov identifier NCT01728363) n = 21. The data from the Staph-Trio study were only included for PK modeling and not intended to be compared in the analysis.
PK sampling schedule for PTN_Clinda Obese was: Pre-dose 0 (within 15 minutes prior to IV clindamycin dose), 0.5 (± 5 minutes) after dose was administered, 1-1.5 hours (hrs) after dose, 3-4 hrs after, 5-6 hrs after, and pre-next dose. Samples were collected on multiple days and averaged to arrive at a single value. Comparison of EBE for volume of distribution by age cohort normalized to 1kg of body weight are presented below.
Sampling schedule details for PTN_POPS & Staph Trio were comparable."|After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6 samples).|In order to determine the impact of obesity and the best weight measure for dosing, only children ≥ 2 years of age were compared (PTN_Clinda obese study n = 21; PTN_POPS study n = 104; and Staph Trio study n = 0). The PK model suggested dosing should be based on Total Body Weight (TBW) regardless of obesity status.||L/kg||Full Range|Median
667157|NCT01744730|Post-Hoc|Half-life|"In order to understand the impact of obesity on clindamycin PK, PK data were combined to build a PK model from 3 studies that included both obese and non-obese children: 1) PTN_Clinda Obese study (clinicaltrials.gov/ct.gov identifier NCT01744730) n = 21; 2) PTN_POPS study (ct.gov identifier NCT01431326) n = 178; and 3) Staph Trio study (ct.gov identifier NCT01728363) n = 21. The data from the Staph-Trio study were only included for PK modeling and not intended to be compared in the analysis.
PK sampling schedule for PTN_Clinda Obese was: Pre-dose 0 (within 15 minutes prior to IV clindamycin dose), 0.5 (± 5 minutes) after dose was administered, 1-1.5 hours (hrs) after dose, 3-4 hrs after, 5-6 hrs after, and pre-next dose. Samples were collected on multiple days and averaged to arrive at a single value. Comparison of empirical Bayesian Estimates (EBE) for half-life by age cohort are presented below.
Sampling schedule details for PTN_POPS and Staph Trio were comparable."|After participant transitioned from IV Clindamycin to oral Clindamycin through Day 14 (minimum of 3 samples; maximum of 6 samples).|In order to determine the impact of obesity and the best weight measure for dosing, only children ≥ 2 years of age were compared (PTN_Clinda obese study n = 21; PTN_POPS study n = 104; and Staph Trio study n = 0). The PK model suggested dosing should be based on Total Body Weight (TBW) regardless of obesity status.||hours||Full Range|Median
667158|NCT01744730|Primary|PK - Volume of Distribution (V) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin.|"In order to understand the impact of obesity on clindamycin PK, PK data were combined to build a PK model from 3 studies that included both obese and non-obese children: 1) PTN_Clinda Obese study (clinicaltrials.gov/ct.gov identifier NCT01744730) n = 21; 2) PTN_POPS study (ct.gov identifier NCT01431326) n = 178; and 3) Staph Trio study (ct.gov identifier NCT01728363) n = 21. The data from the Staph-Trio study were only included for PK modeling and not intended to be compared in the analysis.
PK sampling schedule for PTN_Clinda Obese was: Pre-dose 0 (within 15 minutes prior to IV clindamycin dose), 0.5 (± 5 minutes) after dose was administered, 1-1.5 hours (hrs) after dose, 3-4 hrs after, 5-6 hrs after, and pre-next dose. Samples were collected on multiple days and averaged to arrive at a single value. Comparison of EBE for volume of distribution by age cohort are presented below.
Sampling schedule details for PTN_POPS and Staph Trio were comparable."|After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6 samples).|In order to determine the impact of obesity and the best weight measure for dosing, only children ≥ 2 years of age were compared (PTN_Clinda obese study n = 21; PTN_POPS study n = 104; and Staph Trio study n = 0). The PK model suggested dosing should be based on Total Body Weight (TBW) regardless of obesity status.||L||Full Range|Median
667159|NCT01744730|Primary|Pharmacokinetics (PK) - Clearance (Cl) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin.|"In order to understand the impact of obesity on clindamycin PK, PK data were combined to build a PK model from 3 studies that included both obese and non-obese children: 1) PTN_Clinda Obese study (clinicaltrials.gov/ct.gov identifier NCT01744730) n = 21; 2) PTN_POPS study (ct.gov identifier NCT01431326) n = 178; and 3) Staph Trio study (ct.gov identifier NCT01728363) n = 21. The data from the Staph-Trio study were only included for PK modeling and not intended to be compared in the analysis.
PK sampling schedule for PTN_Clinda Obese was: Pre-dose 0 (within 15 minutes prior to IV clindamycin dose), 0.5 (± 5 minutes) after dose was administered, 1-1.5 hours (hrs) after dose, 3-4 hrs after, 5-6 hrs after, and pre-next dose. Samples were collected on multiple days and averaged to arrive at a single value. Comparison of EBE for clearance by age cohort normalized to 70 kg of body weight are presented below.
Sampling schedule details for PTN_POPS and Staph Trio were comparable."|After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6 samples).|In order to determine the impact of obesity and the best weight measure for dosing, only children ≥ 2 years of age were compared (PTN_Clinda obese study n = 21; PTN_POPS study n = 104; and Staph Trio study n = 0). The PK model suggested dosing should be based on Total Body Weight (TBW) regardless of obesity status.||L/h/70 kg||Full Range|Median
667160|NCT01744730|Primary|Pharmacokinetics (PK) - Clearance (Cl) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin.|"In order to understand the impact of obesity on clindamycin PK, PK data were combined to build a PK model from 3 studies that included both obese and non-obese children: 1) PTN_Clinda Obese study (clinicaltrials.gov/ct.gov identifier NCT01744730) n = 21; 2) PTN_POPS study (ct.gov identifier NCT01431326) n = 178; and 3) Staph Trio study (ct.gov identifier NCT01728363) n = 21. The data from the Staph-Trio study were only included for PK modeling and not intended to be compared in the analysis.
PK sampling schedule for PTN_Clinda Obese was: Pre-dose 0 (within 15 minutes prior to IV clindamycin dose), 0.5 (± 5 minutes) after dose was administered, 1-1.5 hours (hrs) after dose, 3-4 hrs after, 5-6 hrs after, and pre-next dose. Samples were collected on multiple days and averaged to arrive at a single value. Comparison of EBE for clearance by age cohort normalized to 1 kg of body weight are presented below.
Sampling schedule details for PTN_POPS and Staph Trio were comparable."|After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6 samples).|In order to determine the impact of obesity and the best weight measure for dosing, only children ≥ 2 years of age were compared (PTN_Clinda obese study n = 21; PTN_POPS study n = 104; and Staph Trio study n = 0). The PK model suggested dosing should be based on Total Body Weight (TBW) regardless of obesity status.||L/h/kg||Full Range|Median
667161|NCT01744730|Primary|Pharmacokinetics (PK) - Clearance (Cl) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin.|"In order to understand the impact of obesity on clindamycin PK, PK data were combined to build a PK model from 3 studies that included both obese and non-obese children: 1) PTN_Clinda Obese study (clinicaltrials.gov/ct.gov identifier NCT01744730) n = 21; 2) PTN_POPS study (ct.gov identifier NCT01431326) n = 178; and 3) Staph Trio study (ct.gov identifier NCT01728363) n = 21. The data from the Staph-Trio study were only included for PK modeling and not intended to be compared in the analysis.
PK sampling schedule for PTN_Clinda Obese was: Pre-dose 0 (within 15 minutes prior to IV clindamycin dose), 0.5 (± 5 minutes) after dose was administered, 1-1.5 hours (hrs) after dose, 3-4 hrs after, 5-6 hrs after, and pre-next dose. Samples were collected on multiple days and averaged to arrive at a single value. Comparison of empirical Bayesian Estimates (EBE) for clearance by age cohort are presented below.
Sampling schedule details for PTN_POPS and Staph Trio were comparable."|After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6).|In order to determine the impact of obesity and the best weight measure for dosing, only children ≥ 2 years of age were compared (PTN_Clinda obese study n = 21; PTN_POPS study n = 104; and Staph Trio study n = 0). The PK model suggested dosing should be based on Total Body Weight (TBW) regardless of obesity status.||L/h||Full Range|Median
667162|NCT01744691|Secondary|Number of Participants With Treatment Emergent Adverse Events (AEs)|Number of participants who had experienced at least one treatment emergent AE|From first dose of PCI-32765 to within 30 days of last dose for each participant or until study closure|Participants who received at least 1 dose of PCI-32765 and constitute the all treated population.||participants|||Number
667163|NCT01744691|Primary|Overall Response Rate|The primary objective of this study is to evaluate the efficacy of ibrutinib in terms of ORR according to an Independent Review Committee (IRC). ORR based upon IRC assessment is the proportion of responders in the all treated population. Responders were subjects who achieved partial response (PR) or better, ie, complete response (CR), complete response with incomplete marrow recovery (CRi), nodule partial response (nPR) or PR, per IWCLL 2008 criteria with the clarification for treatment-related lymphocytosis.|The median time on study for all treated participants is 33.3 (range 0.5 - 40.1) months|Efficacy analyses were performed on all 144 treated subjects. The primary analysis (PA) used IRC assessment of efficacy endpoints. In the PA, there were no differences between the IRC and investigator responses. IRC assessment was no longer performed after the PA and the final analysis result report investigator-assessed efficacy outcomes.||% of participants with response by PI||95% Confidence Interval|Number
667164|NCT01744496|Secondary|Change From Baseline to the End of the Maintenance Period in the 7 Domain Scores of Classification of Pain in Parkinson's Disease|"The classification of pain in Parkinson’s disease scale classifies pain in the following domains: musculoskeletal pain (item 1), chronic pain (items 2 and 3), fluctuation related pain (items 4, 5 and 6), nocturnal pain (items 7 and 8), oro-facial pain (items 9, 10 and 11), discoloration; edema/swelling (items 12 and 13), and radicular pain (item 14). Severity of the pain is measured on a scale from none (0) to severe (3) and frequency is measured on a scale from never (0) to very frequent (4).
A score of a single item was calculated by multiplying severity with frequency. A domain score was calculated as the sum of every individual score related to the respective domain. A negative value indicates an improvement."|Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS is a subset of the Safety Set and includes all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement.||scores on a scale||Standard Deviation|Mean
667165|NCT01744496|Secondary|Change From Baseline to the End of the Maintenance Period in the Combined Score of the Unified Parkinson's Disease Rating Scale (UPDRS) Parts II (Activities of Daily Living [ADL] Subscale) and III (Motor Subscale)|Part II of the Unified Parkinson's Disease Rating Scale (UPDRS) assesses the subject’s activities of daily living. Part III assesses motor function. The UPDRS is completed by questioning the subject about his/her general state in conjunction with any observations made by the investigator (or designee) since the previous visit. Part II is subject-rated and Part III is physician-rated. The UPDRS Part II (Activities of Daily Living) consists of 13 items scored between 0 and 4. The sum score was calculated as the sum of these 13 individual scores. The UPDRS Part III (motor subscale) consists of 27 items and sub items scored between 0 and 4. The sum score was calculated as sum of these 27 individual scores. The sum score of UPDRS Parts II and III is the sum of the corresponding single sum scores. A negative value indicates an improvement.|Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS is a subset of the Safety Set and includes all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement.||scores on a scale||Standard Deviation|Mean
667166|NCT01744496|Secondary|Change From Baseline to the End of the Maintenance Period in the 7-Item Anxiety Subscore of the Hospital Anxiety and Depression Scale (HADS)|The Hospital Anxiety and Depression Scale (HADS) (Zigmond and Snaith, 1983) is a 14-item self-assessment scale for detecting states of depression and anxiety in the setting of a hospital medical outpatient clinic. It comprises a 7-item anxiety subscale and a 7-item depressive subscale that are also measures of severity of the emotional disorder. The 14 items are scored between 0 and 3. The 7-item depression subscore and 7-item anxiety subscore were calculated as the sum of the 7 corresponding individual scores. A negative value indicates an improvement.|Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS is a subset of the Safety Set and includes all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement.||scores on a scale||Standard Deviation|Mean
667225|NCT01742364|Other Pre-specified|Fluid Leakage on Skin at Injection Site||Immediately post-vaccination|For adults, the skin fluid deposition was estimated and categorized by the vaccinator (e.g., no wetness, damp skin, flow on skin, spray in air); for infants, volume was measured objectively and categorized by the filter paper technique (units in µl).||participants|||Number
667226|NCT01742364|Other Pre-specified|Diameter of Skin Bleb||Immediately post-vaccination|||participants|||Number
667167|NCT01744496|Secondary|Change From Baseline to the End of the Maintenance Period in the 7-Item Depression Subscore of the Hospital Anxiety and Depression Scale (HADS)|The Hospital Anxiety and Depression Scale (HADS) (Zigmond and Snaith, 1983) is a 14-item self-assessment scale for detecting states of depression and anxiety in the setting of a hospital medical outpatient clinic. It comprises a 7-item anxiety subscale and a 7-item depressive subscale that are also measures of severity of the emotional disorder. The 14 items are scored between 0 and 3. The 7-item depression subscore and 7-item anxiety subscore were calculated as the sum of the 7 corresponding individual scores. A negative value indicates an improvement.|Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS is a subset of the Safety Set and includes all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement.||scores on a scale||Standard Deviation|Mean
667168|NCT01744496|Secondary|Change From Baseline to the End of the Maintenance Period in the Sum Score of the 8-Item Parkinson's Disease Questionnaire (PDQ-8)|The 8-Item Parkinson's Disease Questionnaire (PDQ-8) (Peto et al, 1998) is a self-administered questionnaire that provides a reliable measure of overall health status. The PDQ-8 contains 8 items of daily living, with 1 item selected from each of the following 8 scales: mobility, Activities of Daily Living (ADL), emotional well being, stigma, social support, cognitions, communication, and bodily discomfort. The total PDQ-8 score is the sum of all the individual items converted to a summary index score between 0 and 100, with lower scores indicating better health. A negative value indicates an improvement.|Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS is a subset of the Safety Set and includes all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement.||scores on a scale||Standard Deviation|Mean
667169|NCT01744496|Secondary|Percentage of Responders at the End of the Maintenance Period|Responders are defined as patients experiencing a 2-Point or more Reduction on an 11-Point Likert Pain Scale from Baseline to the End of the Maintenance Period. An 11-Point Likert Scale was used to assess patients' average daily pain. The patient rated his/her average pain from 0 (no pain) to 10 (worst pain ever experienced).|Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS is a subset of the Safety Set and includes all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement.||percentage of responders|||Number
667170|NCT01744496|Primary|Change From Baseline to the End of the Maintenance Period in Pain Severity Assessed Using an 11-point Likert Pain Scale|"An 11-Point Likert Scale was used to assess patients' average daily pain. The subject rated his/her average pain from 0 (no pain) to 10 (worst pain ever experienced).
The average pain experienced in the last 7 days was calculated by the mean of the daily Likert Pain Scores within the 7 days prior to the respective visit (ie, Likert Pain Scores with a date of assessment before the date of visit and on or after the date of visit – 7 days). A negative value indicates an improvement."|Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after an up to 7 weeks Titration Period)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS is a subset of the Safety Set and includes all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement.||scores on a scale||Standard Deviation|Mean
667172|NCT01744392|Secondary|Pulse at 6 Months|Clinical Characteristics at 6 month for Pulse|6 months|||beats per minute||Standard Deviation|Mean
667173|NCT01744392|Secondary|Pulse at Baseline|Clinical Characteristics at Baseline for Pulse|baseline|||beats per minute||Standard Deviation|Mean
667174|NCT01744392|Secondary|Weight at 6 Months|Clinical Characteristics at 6 months for Weight|6 months|||pounds||Standard Deviation|Mean
667175|NCT01744392|Secondary|Weight at Baseline|Clinical Characteristics at Baseline for Weight|baseline|||pounds||Standard Deviation|Mean
667176|NCT01744392|Secondary|Cholesterol & Creatinine Levels at 6 Months|Clinical Characteristics at 6 months for LDL, HDL,Total Cholesterol and Creatinine|6 months|||mg/dL||Standard Deviation|Mean
667177|NCT01744392|Secondary|Cholesterol & Creatinine Levels at Baseline|Clinical Characteristics at Baseline for LDL, HDL,Total Cholesterol and Creatinine|baseline|||mg/dL||Standard Deviation|Mean
667178|NCT01744392|Secondary|Blood Pressure at 6 Months|Clinical Characteristics at 6 months for Systolic & Diastolic Blood Pressure,|6 months|||mmHg||Standard Deviation|Mean
667179|NCT01744392|Secondary|Blood Pressure at Baseline|Clinical Characteristics at Baseline for Systolic & Diastolic Blood Pressure,|baseline|||mmHg||Standard Deviation|Mean
667180|NCT01744392|Primary|Medication Possession Ratio at 6 Months|"Medication Possession Ratio (MPR) is defined as the number of daily doses of medication dispensed by the pharmacy to each patient, divided by the patient's total follow-up time. The time period for the assessment for 6 months MPR 6 months after enrollment."|6 months|||percentage of medication possession||Standard Deviation|Mean
667181|NCT01744392|Primary|Medication Possession Ratio at Baseline|"Medication Possession Ratio (MPR) is defined as the number of daily doses of medication dispensed by the pharmacy to each patient, divided by the patient's total follow-up time. The time period for the assessment for baseline MPR 12 months prior to enrollment."|baseline|||percentage of medication possession||Standard Deviation|Mean
667324|NCT01741350|Primary|Female Condom Skills (0-100%)|Participants' HIV risk reduction behavioral skills were assessed based on the percentage of correct necessary steps demonstrated to properly select and apply a female condom using a replica.|Immediately Post-Intervention, at 4 weeks|||percentage of correct steps||Standard Error|Mean
667182|NCT01744353|Secondary|Response Rate (if Patient's Tumor(s)Are Progressing or Being Controlled) Following Treatment With FOLFOX-A for Patients With Newly Diagnosed, Advanced Pancreatic Cancer.|Data below summarizes number of patients who experienced partial response. Partial response evaluated in this study using the international criteria proposed in the Revised Response Evaluation Criteria in Solid Tumors (RECIST) Guideline version 1.1 Response Criteria Partial Response (PR) At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters|pre-drug until disease progression, whichever comes first, for an expected average of 6 months|||participants|||Number
667183|NCT01744353|Primary|Assessment of Toxicities to Define MTD of FOLFOX-Abraxane (A) for Newly Diagnosed, Advanced Pancreatic Cancer.|MTD (Abraxane 150 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion) was defined by protocol documented and predefined DLT's in 3 dose levels.|For up to 30 days post completing drug, an expected average of 6 months|||participants|||Number
667184|NCT01744340|Secondary|Response Rate (Whether Patient's Disease is Progressing or Being Controlled) of Patients With Head and Neck Cancer Treated With Eribulin Mesylate and Cetuximab.|"This shows patients able to achieve Stable disease or better as their best response during course of study participation. Response will be evaluated by Revised Response Evaluation Criteria in Solid Tumors (RECIST) Guideline v1.1 RECIST Guideline version 1.1 Response Criteria Complete Response:Disappearance of all target lesions; Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
Partial Response: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters Progressive Disease:At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Stable Disease:Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study"|From beginning of treatment to progression of disease, for an expected average of 1 year|||participants|||Number
667185|NCT01744340|Primary|If Eribulin Mesylate, up to a Maximum Dose of 1.4 mg/m2 Day 1 and 8 of a 21 Day Cycle, Can be Safely Combined With Full Dose Cetuximab for Patients With Advanced Head and Neck Cancer and Colon Cancer.|"A DLT was defined as:
Grade 4 neutropenia (ANC < 500/mm3) for > 7 days
ANC <1000/mm3 with fever or infection
Platelets <25,000/mm3
Platelets <50,000/mm3 requiring transfusion
Grade 3 or grade 4 treatment related non-hematologic toxicities excluding alopecia. Grade 3 nausea, vomiting or diarrhea will only be considered a dose limiting toxicity if it occurs despite maximal medical support. Grade 3 or grade 4 hypomagnesemia will not be considered a dose limiting toxicity since it is an expected side effect of cetuximab and can be corrected. Other grade 3 or grade 4 electrolyte abnormalities will not be considered dose limiting toxicities if the electrolyte disorder can be corrected to grade 2 or less within 72 hours.
EGFR dermatologic toxicity should be graded according to the toxicity scale for EGFR associated reactions. The first episode of grade 3 or grade 4 rash will not be considered a DLT.
If any patient receives < 70% of the planned dose of eribulin mesylat"|From Day 1 of Drug through end of cycle 2 equals (approximately) 42 days|Outcome measure that address the dose of 1.4 mg/m2,6 patients were treated (1 head and neck 5 colon). 12 patients were enrolled in the course of the MTD dose finding,10 colon and 2 head and neck. All other results sections are inclusive of all patients(dose finding +expansion cohort).||participants|||Number
667186|NCT01744197|Secondary|Global Assessment of Satisfaction With Venipuncture|Rates of Satisfied and very satisfied are used to be compared between two groups.|30 minutes after the venipuncture.|Normal completion patients||percentage of participants|||Number
667187|NCT01744197|Primary|Percentage of Patients With No Pain (VAS=0)|The primary efficacy endpoint is the subject's report of pain intensity regarding the venipuncture using a 0-10 VAS. The VAS =0 is considered as patients with no pain and would also be compared between 2 groups.|30 minutes after the venipuncture.|Normal completion patients||percentage of participants|||Number
667188|NCT01744197|Primary|Percentage of Patients With No or Minor Pain (VAS<3)|The primary efficacy endpoint is the subject's report of pain intensity regarding the venipuncture using a 0-10 VAS. The VAS <3 is considered as patients with no or minor pain and would be compared between 2 groups.|30 minutes after the venipuncture.|Normal completion patients.||percentage of participants|||Number
667189|NCT01743963|Secondary|Feasibility/Reach/Adoption|Measurements of intervention delivery include numbers of veterans excluded from the intervention. Results reported using descriptive statistics (proportions, means, standard deviations, and ranges).|12 months||||||
667190|NCT01743963|Secondary|Feasibility/Reach/Adoption|Measurements of intervention delivery include the rationale used by clinicians declining participation. Results reported using descriptive statistics (proportions, means, standard deviations, and ranges).|12 months||||||
667191|NCT01743963|Secondary|Feasibility/Reach/Adoption|"Measurements of intervention delivery include the representativeness of providers (differences between participants/non-participants). Results reported using descriptive statistics (proportions, means, standard deviations, and ranges)."|12 months||||||
667192|NCT01743963|Secondary|Feasibility/Reach/Adoption|Measurements of intervention delivery include recruitment numbers and provider Participation Rates for enrollment and retention. The definition of study feasibility consists of provider enrollment rates >= 50%. Results reported using descriptive statistics (proportions, means, standard deviations, and ranges).|12 months||||||
667193|NCT01743963|Primary|Delay Interval (Days From Randomization Until the Provider Signs the Order for a hgbA1C Level).|For follow-up laboratory data within the VA system, adherence will be monitored through prospective accrual of administrative data and review of the medical record. Results will be reported as the proportion receiving the preventive measure versus time, i.e. with Kaplan-Meier plots. We will then determine the variance of Delay Interval. For the preliminary measure of efficacy, the Delay Interval will be compared between patients whose providers were assigned to the intervention and patients whose providers did not receive the intervention.|6 MONTHS|21 patients cared for by 6 providers in intervention arm; 17 patients cared for by 6 providers in usual care arm.||Days||95% Confidence Interval|Mean
667194|NCT01743729|Primary|Change From Baseline in Eye Dryness Score (Visual Analogue Scale) to Day 84|Eye dryness score was assessed on a visual analogue scale (a 7-item [burning/stinging, itching, foreign body sensation, eye discomfort, eye dryness, photophobia, and pain], participant-reported, symptom index) with scores ranging from 0 to 100 (0=no discomfort; 100=maximal discomfort) and lower scores indicate a better outcome.|Baseline to Day 84|ITT population with last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
667195|NCT01743729|Primary|Change From Baseline in Inferior Corneal Fluorescein Staining Score to Day 84|Corneal staining was performed to grade the degree of corneal epithelial cell injury as measured by fluorescence using slit-lamp examination. The corneal surface is divided into three regions: superior, central and inferior. The scores for each of these 3 regions ranged from 0 to 4 (0=no staining; 1=few/rare punctate lesions; 2=discrete and countable lesions; 3=lesions too numerous to count, but not coalescent; 4=coalescent) with 0.5 point increments, and lower scores indicate improvement. Inferior corneal fluorescein staining scores from the study eye only were reported. Study eye is the 'worse eye', defined as the eye with worse (higher) score at baseline.|Baseline to Day 84|Intent-to-treat (ITT) set included all randomized participants who received at least 1 dose of study drug.||units on a scale||Standard Deviation|Mean
667196|NCT01743521|Secondary|Gene IL28B Polymorphism|To examine treatment outcome by IL28B polymorphism|Baseline|IL28B polymorphisms have not yet been performed. These are planned to be performed at a later date.|||||
667197|NCT01743521|Secondary|CD4 and HIV RNA|In HIV positive participants to evaluate changes in CD4 counts and HIV RNA during telaprevir based therapy|Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)|This data will not be analysed.|||||
667198|NCT01743521|Secondary|Plasma Ribavirin Levels|To correlate plasma ribavirin levels with treatment outcome and changes in haemoglobin during therapy|Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)|Ribavirin concentration have not yet been performed. These are planned to be performed at a later date.|||||
667199|NCT01743521|Secondary|Baseline Resistance-associated Variants|To correlate the presence and frequency of baseline resistance-associated variants (RAVs) with the response of Telaprevir based therapy for early chronic HCV infection.|Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)|Baseline resistance-associated variants analysis have not yet been performed. These are planned to be performed at a later date.|||||
667200|NCT01743521|Secondary|Resistance-associated Variants|To examine the emergence of resistance-associated variants during telaprevir based therapy for early chronic infection|Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)|Resistance-associated variants analysis have not yet been performed. These are planned to be performed at a later date.|||||
667201|NCT01743521|Secondary|Change in Hemoglobin at End of Treatment|To evaluate indicators of toxicity during telaprevir based therapy|Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)|||g/L||Inter-Quartile Range|Median
667202|NCT01743521|Secondary|Decrease in Platelets <50||Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)|||participants|||Number
667203|NCT01743521|Secondary|Decrease in Absolute Neutrophil Count (ANC) ≤0.75||Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)|||participants|||Number
667204|NCT01743521|Secondary|Undetectable HCV RNA (Week 4)|To evaluate the proportion of patients with undetectable HCV RNA at week 4 of therapy.|Week 4 of therapy|Missing data carried forward if previously <LLoQ||percentage of participants|||Number
667205|NCT01743521|Secondary|Undetectable HCV RNA (Week 3)|To evaluate the proportion of patients with undetectable HCV RNA at week 3 of therapy.|Week 3 of therapy|Missing data carried forward if previously <LLoQ (lower limit of quantification)||percentage of participants|||Number
667206|NCT01743521|Secondary|Undectectable HCV RNA (Week 2)|To evaluate the proportion of patients with undetectable HCV RNA at week 1 of therapy.|Week 2 of therapy|||percentage of participants|||Number
667207|NCT01743521|Secondary|Undetectable HCV RNA (Week 1)|To evaluate the proportion of patients with undetectable HCV RNA at week 1 of therapy.|Week 1 of therapy|||percentage of participants|||Number
667208|NCT01743521|Secondary|Undetectable HCV RNA (ETR)|To evaluate the proportion of patients with undetectable HCV RNA at end of treatment (ETR)|Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)|||percentage of participants|||Number
667209|NCT01743521|Secondary|SVR24|To evaluate the proportion of patients with undetectable HCV RNA 24 weeks after therapy completion (SVR24)|24 weeks post-treatment|||percentage of participants|||Number
667210|NCT01743521|Primary|SVR12 (Sustain Virological Response, HCV RNA Undetectable 12 Weeks Post-treatment)|Proportion of subjects achieving SVR 12 (negative qualitative HCV RNA 12 weeks after therapy completion)|12 weeks post-treatment|||percentage of participants|||Number
667211|NCT01743092|Secondary|DASS Depression|"The Depression, Anxiety and Stress Scale (DASS 21) is a 21 item self-report questionnaire developed by Lovibond, S.H. & Lovibond, P.F. (1995, Manual for the Depression Anxiety Stress Scales, 2nd. Ed., Sydney: Psychology Foundation).
The range of total scores for each subscale is from 0 to 21. Higher values represent a worse outcome. Depression Normal 0-4 Mild 5-6 Moderate 7-10 Severe 11-13 Extremely Severe 14+ Anxiety Normal 0-3 Mild 4-5 Moderate 6-7 Severe 8-9 Extremely Severe 10+ Stress Normal 0-7 Mild 8-9 Moderate 10-12 Severe 13-16 Extremely Severe 17+"|12 weeks|The number of data points in this analysis equals the number who completed the study.||units on a scale||Standard Deviation|Mean
667212|NCT01743092|Primary|Perceived Stress Scale|"The questionnaire asks the client about their perceived stress. The Perceived Stress Scale (Cohen, S., Kamarck, T., and Mermelstein, R. (1983). A global measure of perceived stress. Journal of Health and Social Behavior, 24, 386-396. December 1983) is a scale developed to measure the degree to which situations in one’s life are appraised as stressful. Psychological stress has been defined as the extent to which persons perceive (appraise) that their demands exceed their ability to cope. The PSS has become one of the most widely used psychological instruments for measuring nonspecific perceived stress.
The scale has ten questions asking respondents to circle a number between 0 and 4. (0 the feelings and thoughts during the last month: 0 = Never 1 = Almost Never 2 = Sometimes 3 = Fairly Often 4 = Very Often. The range of possible score is from 0 to 40. Scores around 13 are considered average. Scores of 20 or higher are considered to be indicative of high stress levels."|12 weeks|The number of data points in this analysis equals the number who completed the study, minus 2. There were 2 missing data points in this analysis because two people did not complete the questionnaire.||units on a scale||Standard Deviation|Mean
667236|NCT01741792|Secondary|CD8+ TCM Cell Counts|Central memory T cells are characterized by the cell-surface expression of CD197 but not CD45RA and were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).||100 cells/µL||Standard Deviation|Mean
667213|NCT01743027|Secondary|Proportion of Itch Responders at 24 Hours Duration of Action|A treatment efficacy CAC was performed 24 hours after drop instillation on Day 0. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). A responder was defined as a participant with zero-itch (a score of zero on ocular itching for both eyes) or with at least 2 units reduction in ocular itching relative to the baseline confirmatory CAC score. Ocular itching score was averaged across both eyes and over the 3 post-CAC assessments (3, 5, and 7 minutes) for the calculation of units reduction. Proportion of Ocular Itching Responders is reported as a percentage.|Day 1|Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication.Patients with missing data were considered as nonresponders in this analysis.||percentage of participants|||Number
667214|NCT01743027|Secondary|Proportion of Ocular Itching Responders at Onset of Action|A treatment efficacy CAC was performed 27 minutes after drop installation. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). A responder was defined as a participant with zero-itch (a score of zero on ocular itching for both eyes) or with at least 2 units reduction in ocular itching relative to the baseline confirmatory CAC score. Ocular itching score was averaged across both eyes and over the 3 post-CAC assessments (3, 5, and 7 minutes) for the calculation of units reduction. Proportion of Ocular Itching Responders is reported as a percentage.|Day 14|Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication. Patients with missing data were considered as nonresponders in this analysis.||percentage of participants|||Number
667215|NCT01743027|Secondary|Mean Total Redness at 24 Hours Duration of Action|A treatment efficacy CAC was performed 24 hours after drop instillation on Day 0. Conjunctival redness, ciliary redness, and episcleral redness were assessed by the investigator on 0-4 scale (0=none, 4=extremely severe). Total redness is a composite variable summing conjunctival redness, ciliary redness, and episcleral redness scores (resultant score 0-12). The average of total redness over both eyes was analyzed.|Day 1 (7, 15, and 20 minutes post-CAC)|Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication.||units on a scale||Standard Error|Least Squares Mean
667216|NCT01743027|Secondary|Mean Total Redness at Onset of Action|A treatment efficacy CAC was performed 27 minutes after drop installation. Conjunctival redness, ciliary redness, and episcleral redness were assessed by the investigator on 0-4 scale (0=none, 4=extremely severe). Total redness is a composite variable summing conjunctival redness, ciliary redness, and episcleral redness scores (resultant score 0-12). The average of total redness over both eyes was analyzed.|Day 14 (7, 15, and 20 minutes post-CAC)|Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication.||units on a scale||Standard Error|Least Squares Mean
667217|NCT01743027|Secondary|Mean Conjunctival Redness at 24 Hours Duration of Action|A treatment efficacy CAC was performed 24 hours after drop instillation on Day 0. Conjunctival redness was assessed by the investigator on a 0-4 scale (0=none, 4=extremely severe). Average of conjunctival redness score over both eyes was analyzed.|Day 1 (7, 15, and 20 minutes post-CAC)|Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication.||units on a scale||Standard Error|Least Squares Mean
667218|NCT01743027|Secondary|Mean Conjunctival Redness at Onset of Action|A treatment efficacy CAC was performed 27 minutes after drop installation. Conjunctival redness was assessed by the investigator on a 0-4 scale (0=none, 4=extremely severe). Average of conjunctival redness score over both eyes was analyzed.|Day 14 (7, 15, and 20 minutes post-CAC)|Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication.||units on a scale||Standard Error|Least Squares Mean
667219|NCT01743027|Primary|Mean Ocular Itching at 24 Hours Duration of Action|A treatment efficacy CAC was performed 24 hours after drop instillation on Day 0. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). Average of ocular itching score over both eyes was analyzed.|Day 1 (3, 5, and 7 minutes post-CAC)|Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication.||units on a scale||Standard Error|Least Squares Mean
667220|NCT01743027|Primary|Mean Ocular Itching at Onset of Action|A treatment efficacy CAC was performed 27 minutes after drop installation. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). Average of ocular itching score over both eyes was analyzed.|Day 14 (3, 5, and 7 minutes post-CAC)|Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication.||units on a scale||Standard Error|Least Squares Mean
667221|NCT01742936|Primary|International Normalized Ratio (INR) Performed by Hospital Laboratory|Measuring the bloods ability to clot by the hospital's reference laboratory.|At end of surgery (an average of 2-4 hrs for cardiac bypass and 4-6 hrs. for spinal fusion)|Three cases of device error with CoaguChek®, 1 insufficient blood for measurement in the laboratory, and 1 communication failure during sending the blood sample to the laboratory occurred leaving 87 patients for analysis.||ratio||Standard Deviation|Mean
667222|NCT01742936|Primary|International Normalized Ratio (INR) on CoaguChek|Measuring the blood's ability to clot on a handheld monitor.|At end of surgery (an average of 2-4 hrs for cardiac bypass and 4-6 hrs. for spinal fusion)|||ratio||Standard Deviation|Mean
667223|NCT01742897|Primary|Change From Baseline in Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) Score at Day 30|The WOMAC is a self administered, participant health related questionnaire consisting of three subscales (pain, stiffness and physical function). Pain subscale score ranges from 0-100 mm (0 mm=no pain to 100 mm=extreme pain); stiffness subscale score ranges from 0-100 mm (0 mm=no stiffness to 100 mm=extreme stiffness) and physical function subscale ranges from 0-100 mm (0 mm=no difficulty to 100 mm=extreme difficulty). The overall WOMAC score is the sum of the 3 subscale scores which ranges from 0-300 mm (0 mm=none to 300 mm=extreme/worst).|Baseline, Day 30|Intent-to-treat (ITT) analysis population included all participants regardless of their compliance with the protocol.||Millimeter (mm)||95% Confidence Interval|Median
667224|NCT01742832|Primary|Montgomery-Åsberg Depression Rating Scale (MADRS)|"The entire study will last 18 weeks. For the first 6 weeks, subjects will come in once every 2 weeks. For the next 4 weeks, subjects will come in once per week. For the next 6 weeks, subjects will come in once every 2 weeks. The final visit will come 2 weeks later for a total of 11 visits where the MADRS will be administered. Only the baseline and final (last observation) assessments for the outcome measure was used in determining results, thus these are the only values included.
MADRS scores range from 0-60, with higher scores indicating a greater level of severity. No subscales were used."|Baseline and final MADRS scores during the double-blind phase.|||units on a scale||Standard Deviation|Mean
667227|NCT01742364|Primary|Short Term Whole Blood Intracellular Cytokine Staining Assay for BCG-specific CD4 T-cells|"BCG-specific immunogenicity was tested in infants only, since they are the target study population and BCG immunogenicity in adults is known to be different from that in infants.
Utilizing a whole-blood intracellular cytokine staining (ICS) assay, we analyzed cytokine co-expression patterns by BCG-specific CD4 and CD8 T-cells. Briefly, 0.5 ml heparinized whole blood was incubated for 12 hours with BCG, no antigen or phytohemagglutinin (PHA) in the presence of anti-CD28 and anti-CD49d, with the last 5 hours including Brefeldin A prior to treating with BD FACS™ Lysing Solution and cryopreservation. Cells were batch-thawed, permeabilized with BD Perm/Wash™ buffer, and stained with fluorescent antibodies. At least 120,000 CD3+CD4+ T-cells were acquired for the no-antigen and BCG samples on a BD™ LSR II flow cytometer."|14 weeks post-vaccination|"Due to failed phlebotomy on 5 infants, results were not available for 2 participants in the Bioject ID Pen arm and for 3 participants in the Needle and syringe arm.
Immunogenicity was not measured for adults in the study."||percentage responding to cytokines||Inter-Quartile Range|Median
667228|NCT01742364|Primary|Short Term Whole Blood Intracellular Cytokine Staining Assay for BCG-specific CD4 (Cluster of Differentiation 4) T-cells|"BCG-specific immunogenicity was tested in infants only, since they are the target study population and BCG immunogenicity in adults is known to be different from that in infants.
Utilizing a whole-blood intracellular cytokine staining (ICS) assay, we analyzed cytokine co-expression patterns by BCG-specific CD4 and CD8 T-cells. Briefly, 0.5 ml heparinized whole blood was incubated for 12 hours with BCG, no antigen or phytohemagglutinin (PHA) in the presence of anti-CD28 and anti-CD49d, with the last 5 hours including Brefeldin A prior to treating with BD FACS™ Lysing Solution and cryopreservation. Cells were batch-thawed, permeabilized with BD Perm/Wash™ buffer, and stained with fluorescent antibodies. At least 120,000 CD3+CD4+ T-cells were acquired for the no-antigen and BCG samples on a BD™ LSR II flow cytometer."|10 weeks post-vaccination|"Due to failed phlebotomy on 5 infants, results were not available for 2 participants in the Bioject ID Pen arm and for 3 participants in the Needle and syringe arm.
Immunogenicity was not measured for adults in the study."||percentage responding to cytokines||Inter-Quartile Range|Median
667229|NCT01742364|Primary|Systemic Adverse Events|Systemic adverse events, solicited and unsolicited, including symptoms of lethargy, disrupted feeding patterns, fever, lymphadenopathy, rash, or any other physical abnormalities will be monitored for up to fourteen weeks following vaccination.|14 weeks|||Adverse events|||Number
667230|NCT01742364|Primary|Injection Site Adverse Events (Following Injection)|Injection site adverse events including redness, swelling, induration, tenderness, ulceration, fluctuation , drainage, laceration, bruising, and scarring will be monitored for up to fourteen weeks following vaccination.|14 weeks|||Adverse events|||Number
667231|NCT01741792|Secondary|CD8+ TEMRA Cells as a Percentage of All CD8+ T-Cells|Terminally differentiated effector memory T cells are characterized by the cell-surface expression of CD45RA but not CD197 and were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).||percentage of CD8+ T-cells||Standard Deviation|Mean
667232|NCT01741792|Secondary|CD8+ Terminally Differentiated Effector Memory T-cells (TEMRA) Count|Terminally differentiated effector memory T cells are characterized by the cell-surface expression of CD45RA but not CD197 and were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).||1000 cells/µL||Standard Deviation|Mean
667233|NCT01741792|Secondary|CD8+ TEM Cells as a Percentage of All CD8+ T-Cells|Effector memory T cells are characterized by the lack of expression of CD197 and CD45RA and were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).||percentage of CD8+ T-cells||Standard Deviation|Mean
667234|NCT01741792|Secondary|CD8+ Effector Memory T-Cell (TEM) Count|Effector memory T cells are characterized by the lack of expression of CD197 and CD45RA and were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).||1000 cells/µL||Standard Deviation|Mean
667235|NCT01741792|Secondary|CD8+ TCM Cells as a Percentage of All CD8+ T-Cells|Central memory T cells are characterized by the cell-surface expression of CD197 but not CD45RA and were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).||percentage of CD8+ T-cells||Standard Deviation|Mean
667283|NCT01741688|Secondary|Percentage of Participants Discontinued From Tocilizumab for Safety|Safety variable measuring number of patients that discontinued tocilizumab due to adverse reactions to tocilizumab.|Approximately 16 months|||percentage of participants|||Number
667284|NCT01741688|Secondary|Median Duration of Treatment||Approximately 16 months|||months||Full Range|Median
667237|NCT01741792|Secondary|CD8+ Naive T-Cells as a Percentage of All CD8+ T-Cells|CD8+ naive T-cell counts are native T-cells characterized by the cell-surface expression of CD197 and CD45RA and were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).||percentage of CD8+ T-cells||Standard Deviation|Mean
667238|NCT01741792|Secondary|CD8+ Naive T-Cell Count|CD8+ naive T-cell counts are native T-cells characterized by the cell-surface expression of CD197 and CD45RA and were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).||1000 cells/µL||Standard Deviation|Mean
667239|NCT01741792|Secondary|CD4+ TEM Cells as a Percentage of All CD4+ T-Cells|Effector memory T cells are characterized by the lack of expression of CD197 and CD45RA and were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).||percentage of CD4+ T-cells||Standard Deviation|Mean
667240|NCT01741792|Secondary|CD4+ Effector Memory T-Cell (TEM) Count|Effector memory T cells are characterized by the lack of expression of CD197 and CD45RA and were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).||1000 cells/µL||Standard Deviation|Mean
667241|NCT01741792|Secondary|CD4+ TCM Cells as a Percentage of All CD4+ T-Cells|Central memory T cells are characterized by the cell-surface expression of CD197 but not CD45RA and were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).||percentage of CD4+ T-cells||Standard Deviation|Mean
667242|NCT01741792|Secondary|CD4+ Central Memory T-Cell (TCM) Count|Central memory T cells are characterized by the cell-surface expression of CD197 but not CD45RA and were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).||1000 cells/µL||Standard Deviation|Mean
667243|NCT01741792|Secondary|CD4+ Naive T Cells as a Percentage of All CD4+ T-Cells|CD4+ naive T-cell counts are native T-cells characterized by the cell-surface expression of CD197 and CD45RA and were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).||percentage of CD4+ T-cells||Standard Deviation|Mean
667244|NCT01741792|Secondary|CD4+ Naive T Cell Count|CD4+ naive T-cell counts are native T-cells characterized by the cell-surface expression of CD197 and CD45RA and were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).||1000 cells/µL||Standard Deviation|Mean
667245|NCT01741792|Secondary|CD4+ T-Cell to CD8+ T-Cell Ratio|CD4+ T-cells and CD8+ T-cell counts were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).||ratio||Standard Deviation|Mean
667246|NCT01741792|Secondary|CD19+ B-Cell to CD3+ T-Cell Ratio|CD19+ B-cells and CD3+ T-cell counts were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).||ratio||Standard Deviation|Mean
667247|NCT01741792|Secondary|CD8+ T-Cells as a Percentage of All Lymphocytes|CD8+ T-cell counts were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).||percentage of lymphocytes||Standard Deviation|Mean
667248|NCT01741792|Secondary|CD8+ T-Cell Count|CD8+ T-cell counts were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).||1000 cells/µL||Standard Deviation|Mean
667249|NCT01741792|Secondary|CD4+ T-Cells as a Percentage of All Lymphocytes|CD4+ T-cell counts were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).||percentage of lymphocytes||Standard Deviation|Mean
667250|NCT01741792|Secondary|CD4+ T-Cell Count|CD4+ T-cell counts were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).||1000 cells/µL||Standard Deviation|Mean
667251|NCT01741792|Secondary|CD3+ T-Cells as a Percentage of All Lymphocytes|CD3+ T-cell counts were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).||percentage of lymphocytes||Standard Deviation|Mean
667252|NCT01741792|Secondary|CD3+ T-Cell Count|CD3+ T-cell counts were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).||1000 cells/µL||Standard Deviation|Mean
667253|NCT01741792|Secondary|CD19+ B-Cells as a Percentage of All Lymphocytes|CD19+ B-cell counts were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).||percentage of lymphocytes||Standard Deviation|Mean
667254|NCT01741792|Secondary|CD19+ B-Cell Count|CD19+ B-cell counts were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).||1000 cells/µL||Standard Deviation|Mean
667255|NCT01741792|Secondary|Granulocyte Count||Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).||1000 cells/µL||Standard Deviation|Mean
667256|NCT01741792|Secondary|Monocyte Counts||Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).||1000 cells/µL||Standard Deviation|Mean
667257|NCT01741792|Secondary|Lymphocyte Counts|Lymphocyte counts were analyzed by differential blood count analysis.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).||1000 cells/µL||Standard Deviation|Mean
667285|NCT01741688|Secondary|Number of Participants With Dose Modifications at 6 Months||At 6 months|||participants|||Number
667258|NCT01741792|Secondary|Leukocyte Counts|Leukocyte (white blood cells) counts were analyzed by differential blood count analysis.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).||1000 cells/µL||Standard Deviation|Mean
667259|NCT01741792|Secondary|Blinatumomab Steady State Serum Concentration|Blinatumomab serum levels were analyzed using a validated cluster of differentiation (CD)69 activation bioassay with a lower limit of quantification (LLOQ) of 50 pg/mL. Steady-state concentration (Css) was based on actual dose received, rather than based on cohort or time or day.|Cycle 1: predose; Day 3 and Day 8 (Css for 9 ug/day); Day 15 (Css for 28 ug/day); and Day 29, Day 43 and Day 57 (Css for 112 ug/day)|Pharmacokinetic (PK) data set (all participants who received any infusion of blinatumomab and had at least one PK sample collected).||pg/mL||Standard Deviation|Mean
667260|NCT01741792|Secondary|Number of Participants With Adverse Events|"Adverse events were evaluated for severity according to the grading scale provided in the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.
An adverse event or suspected adverse drug reaction was considered serious if it resulted in one of the following outcomes:
Resulted in death;
Was life-threatening;
Required inpatient hospitalization or prolongation of existing hospitalization;
Resulted in persistent or significant incapacity or substantial disruption to conduct normal life functions;
Was a congenital anomaly or birth defect;
Was a medically important condition.
The Investigator used medical judgment to determine whether there was a causal relationship (ie, related [reasonably possible] or unrelated [not reasonably possible]) between an adverse event and blinatumomab."|From the first dose of blinatumomab until up to 30 days after the last dose or until the data cut-off date of 10 July 2014, whichever occurred first; the overall median duration of treatment exposure was 46.8 days.|Safety analysis set||participants|||Number
667261|NCT01741792|Secondary|Overall Survival (OS)|The time from the date of first blinatumomab infusion until death as a result of any cause. Patients still alive were censored on the last documented visit date or the date of the last phone contact when the patient was last known to have been alive. For patients who withdrew their informed consent, only information until the date of withdrawal was analyzed.|From the first infusion of blinatumomab until the end of study; median time on follow-up for overall survival was 26.6 months.|Efficacy set||months||95% Confidence Interval|Median
667262|NCT01741792|Secondary|Progression-free Survival (PFS)|The time from the date of first blinatumomab infusion until the date of diagnosis of progression of lymphoma, the start date of new anti-tumor treatment (excluding any stem cell transplantation) or date of death, whichever is the earliest. Patients alive who did not have progression or new anti-tumor treatment (excluding any stem cell transplantation) were censored at last date of tumor assessment.|From first infusion of blinatumomab until the end of study; median time on follow-up for PFS was 27.0 months.|Efficacy set||months||95% Confidence Interval|Median
667263|NCT01741792|Secondary|Duration of Partial Response|The time from documentation of the first assessment of partial response until the start of new anti-tumor treatment (excluding any stem cell transplantation), progression of disease, or death, whichever is the earliest event. A patient who did not have new anti-tumor treatment (excluding any stem cell transplantation), progression of disease, or death was censored at last tumor assessment date. Disease progression is defined as any new lesion or increase by ≥ 50% of previously involved sites from nadir.|From first infusion of blinatumomab until the end of study; median follow-up time for duration of response was 23.7 months.|Efficacy set with a best overall response of PR during the first treatment cycle||months||95% Confidence Interval|Median
667264|NCT01741792|Secondary|Duration of Complete Response|The time from documentation of the first assessment of complete response until the start of new anti-tumor treatment (excluding any stem cell transplantation), progression of disease, or death, whichever is the earliest event. A patient who did not have new anti-tumor treatment (excluding any stem cell transplantation), progression of disease, or death was censored at last tumor assessment date. Disease progression is defined as any new lesion or increase by ≥ 50% of previously involved sites from nadir.|From first infusion of blinatumomab until the end of study; median follow-up time for duration of response was 23.7 months.|Efficacy set with a best overall response of CR during the first treatment cycle||months||95% Confidence Interval|Median
667265|NCT01741792|Secondary|Duration of Objective Response|The time from documentation of the first assessment of either partial or complete response until the start of new anti-tumor treatment (excluding any stem cell transplantation), progression of disease, or death, whichever is the earliest event. A patient who did not have new anti-tumor treatment (excluding any stem cell transplantation), progression of disease, or death was censored at last tumor assessment date. Disease progression is defined as any new lesion or increase by ≥ 50% of previously involved sites from nadir.|From first infusion of blinatumomab until the end of study; median follow-up time for duration of response was 23.7 months.|Efficacy set with an overall objective response of CR or PR during the first treatment cycle||months||95% Confidence Interval|Median
667266|NCT01741792|Secondary|Percentage of Participants With a Best Overall Response of Partial Response|Response within the first treatment cycle was assessed according to Cheson criteria by a central reader. Response was evaluated using computerized tomography (CT) scans and positron emission tomography (PET) (to assess nodal disease/organ enlargement due to nodal/diffuse infiltration), and bone marrow biopsy (to assess bone marrow infiltration). Partial response is defined as regression (<50% decrease in size of masses) of measureable disease and no new sites.|During the first 8 weeks|Efficacy set||percentage of participants||95% Confidence Interval|Number
667267|NCT01741792|Secondary|Percentage of Participants With a Best Overall Response of Complete Response|Response within the first treatment cycle was assessed according to Cheson criteria by a central reader. Response was evaluated using computerized tomography (CT) scans and positron emission tomography (PET) (to assess nodal disease/organ enlargement due to nodal/diffuse infiltration), and bone marrow biopsy (to assess bone marrow infiltration). Complete response is defined as the disappearance of all evidence of disease.|During the first 8 weeks|Efficacy set||percentage of participants||95% Confidence Interval|Number
667286|NCT01741688|Secondary|Median Dose at 6 Months||At 6 months|Number of participants remaining in the study at 6 months||mg/kg of body weight||Full Range|Median
667268|NCT01741792|Primary|Overall Objective Response Rate During Treatment Cycle 1|"Overall response within the first treatment cycle was assessed according to Cheson criteria by a central reader. Response was evaluated using computerized tomography (CT) scans and positron emission tomography (PET) (to assess nodal disease/organ enlargement due to nodal/diffuse infiltration), and bone marrow biopsy (to assess bone marrow infiltration). Overall objective response rate (ORR) is the percentage of participants with a best overall response of complete response (CR) or partial response (PR).
Complete response is defined as the disappearance of all evidence of disease and partial response is defined as regression of measureable disease and no new sites."|During the first 8 weeks|Efficacy Set includes all participants who completed at least 7 days of infusion on the highest intended dose level.||percentage of participants||95% Confidence Interval|Number
667269|NCT01741701|Secondary|NonMotor Symptom Questionnaire (NMSQuest)|"The NMSQuest is a 30 item questionnaire with 30 yes/no questions. There is a total of 30 points with each yes score representing 1 point and therefore the higher the score the greater number of nonmotor symptoms present. The score can range from 0 to 30."|4 months|Only subjects that completed the study were included in the efficacy analyses, those that withdrew were not included in the efficacy analysis.||units on a scale||Standard Deviation|Mean
667270|NCT01741701|Secondary|Geriatric Depression Scale (GDS)|The GDS is a measure of depression. The scale has 30 yes/no questions. Each question has a maximum score of 1 and a total possible score ranging from 0 to 30. The higher the score the greater the depression.|4 months|Only subjects that completed the study were included in the efficacy analyses, those that withdrew were not included in the efficacy analysis.||units on a scale||Standard Deviation|Mean
667271|NCT01741701|Secondary|Montreal Cognitive Assessment (MoCA)|The MoCA is an assessment of cognitive function. The total possible score ranges from 0 to 30 points with a lower score representing greater cognitive impairment.|4 months|Only subjects that completed the study were included in the efficacy analyses, those that withdrew were not included in the efficacy analysis.||units on a scale||Standard Deviation|Mean
667272|NCT01741701|Secondary|Parkinson's Disease Questionnaire - 39 (PDQ-39)|The PDQ-39 is a measure of quality of life in Parkinson's disease patients. It has 39 questions each with a response from 0-4 for a total of 156 points. The total score is calculated as a percentage so the scores of the 39 items are added and divided by 156 and multiplied by 100. The higher the score the worse quality of life.|4 months|Only subjects that completed the study were included in the efficacy analyses, those that withdrew were not included in the efficacy analysis.||percentage of total possible score||Standard Deviation|Mean
667273|NCT01741701|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) ADL + Motor Score|The UPDRS has 3 subscales including Mentation (4 questions based on patient report with answers on a scale of 0-4, with a total of 16 points), Activities of Daily Living (13 questions based on patient report with answers on a scale of 0-4, with a total of 52 points) and Motor (27 questions based on clinician assessment on a scale of 0-4, with a total of 108 points). This measure examined the ADL + Motor subscales which have a total of 160 points with a higher score representing greater dysfunction.|4 months|Only subjects that completed the study were included in the efficacy analyses, those that withdrew were not included in the efficacy analysis.||units on a scale||Standard Deviation|Mean
667274|NCT01741701|Primary|Unified Parkinson's Disease Rating Scale (UPDRS) Total Score|The UPDRS has 3 subscales including Mentation (4 questions based on patient report with answers on a scale of 0-4, with a total of 16 points), Activities of Daily Living (13 questions based on patient report with answers on a scale of 0-4, with a total of 52 points) and Motor (27 questions based on clinician assessment on a scale of 0-4, with a total of 108 points). The total scores represents the sum of each of these sections for a total of 176 points with a higher score representing greater dysfunction.|4 months|Only subjects that completed the study were included in the efficacy analyses, those that withdrew were not included in the efficacy analysis.||units on a scale||Standard Deviation|Mean
667275|NCT01741688|Secondary|Disease Activity Score Based on 28 Joints (DAS28)|"The DAS28 is a measure of disease activity in rheumatoid arthritis (RA) and the number 28 refers to the 28 joints that are examined in this assessment. To calculate the DAS28 the following assessments are done: 1) count the number of swollen joints (out of the 28 [sw28]), 2) count the number of tender joints (out of the 28 [t28]), 3) measure Erythrocyte Sedimentation Rate (ESR), and 4) ask the participant to make a 'global assessment of health' (GH) indicated by marking a 10 cm line between very good and very bad.
The Score is developed under the follow formula:
DAS28(4) = 0.56*sqrt(t28) + 0.28*sqrt(sw28) + 0.70*Ln(ESR) + 0.014*GH Where, t=tender joints; sw=swollen joints; ESR= Erythrocyte Sedimentation Rate; GH=Global assessment of health score.
This score may range from 0 to 9.3, where a DAS28 of greater than 5.1 implies active disease, less than 3.2 low disease activity, and less than 2.6 remission."|At Visit 1 (Baseline), Observation 1: up to 4 weeks, Observation 2: up to 8 weeks; Observation 3: up to 12 weeks; Observation 4: up to 16 weeks and Observation 5: up to 20 weeks|||DAS28 score||Full Range|Median
667276|NCT01741688|Secondary|Total Swollen Joint Count (SJC)||At Visit 1 (Baseline), Observation 1: up to 4 weeks, Observation 2: up to 8 weeks; Observation 3: up to 12 weeks; Observation 4: up to 16 weeks and Observation 5: up to 20 weeks|||Number of swollen joints/participant||Full Range|Median
667277|NCT01741688|Secondary|Total Tender Joint Count (TJC)||At Visit 1 (Baseline), Observation 1: up to 4 weeks, Observation 2: up to 8 weeks; Observation 3: up to 12 weeks; Observation 4: up to 16 weeks and Observation 5: up to 20 weeks|||Number of tender joints/participant||Full Range|Median
667278|NCT01741688|Secondary|Percentage of Participants on Tocilizumab Monotherapy at Study Entry||At baseline|||percentage of participants|||Number
667279|NCT01741688|Secondary|Non-adherence Rate of Physician to the Recommended Dosing Regimen||Approximately 16 months||||||
667280|NCT01741688|Secondary|Time to Restoration of Initial Dosing Regimen||Approximately 16 months||||||
667281|NCT01741688|Secondary|Number of Participants Discontinued From Tocilizumab for Other Reasons|This variable measures the number of events not related to safety or efficacy leading to discontinuation of tocilizumab treatment.|Approximately 16 months|||participants|||Number
667282|NCT01741688|Secondary|Percentage of Participants Discontinued From Tocilizumab for Lack of Efficacy|Efficacy variable that measures the rate of participants discontinued from tocilizumab due to lack of efficacy according to criteria of treating physician.|Approximately 16 months|||percentage of participants|||Number
667287|NCT01741688|Secondary|Number of Participants Starting Tocilizumab After Failing Other Biologic Agents|Other biologic agents include anti-Tumor Necrosis Factor (TNF) antibody.|At baseline|||participants|||Number
667288|NCT01741688|Secondary|Percentage of Participants Starting Tocilizumab After Prior and Baseline Disease-Modifying Anti-rheumatic Drugs (DMARDs) Exposure|"DMARDs exposure was evaluated for all participants. Prior DMARDs treatment includes participants, who were treated with DMARDs 6 months before being included in the study. DMARDs treatment at baseline includes participants, who were receiving DMARDs when they were included in the study and continued with this concomitant medication to tocilizumab."|At baseline|||percentage of participants|||Number
667289|NCT01741688|Secondary|Percentage of Participants With Systemic Manifestations of Rheumatoid Arthritis|Systemic manifestation measured by C-reactive protein levels > 3|At baseline|||percentage of participants|||Number
667290|NCT01741688|Primary|Number of Participants on Tocilizumab at 6 Months After Treatment Initiation||At 6 months|||participants|||Number
667291|NCT01741350|Primary|Self-efficacy to Reduce Sex-related HIV- Risk Behavior (1-5)|"Participants completed a questionnaire assessing their self-efficacy about reducing sex-related HIV-risk behavior (e.g., If asked, I am confident I could demonstrate how to use male condom and female condoms correctly) and were rated on a scale of 1 to 5, with a higher score indicating greater self-efficacy to reduce sex-related HIV-risk behavior."|12-month follow up|||units on a scale||Standard Error|Mean
667292|NCT01741350|Primary|Self-efficacy to Reduce Sex-related HIV- Risk Behavior (1-5)|"Participants completed a questionnaire assessing their self-efficacy about reducing sex-related HIV-risk behavior (e.g., If asked, I am confident I could demonstrate how to use male condom and female condoms correctly) and were rated on a scale of 1 to 5, with a higher score indicating greater self-efficacy to reduce sex-related HIV-risk behavior."|6-month follow up|||units on a scale||Standard Error|Mean
667293|NCT01741350|Primary|Self-efficacy to Reduce Sex-related HIV- Risk Behavior (1-5)|"Participants completed a questionnaire assessing their self-efficacy about reducing sex-related HIV-risk behavior (e.g., If asked, I am confident I could demonstrate how to use male condom and female condoms correctly) and were rated on a scale of 1 to 5, with a higher score indicating greater self-efficacy to reduce sex-related HIV-risk behavior."|3-month follow up|||units on a scale||Standard Error|Mean
667294|NCT01741350|Primary|Self-efficacy to Reduce Sex-related HIV- Risk Behavior (1-5)|"Participants completed a questionnaire assessing their self-efficacy about reducing sex-related HIV-risk behavior (e.g., If asked, I am confident I could demonstrate how to use male condom and female condoms correctly) and were rated on a scale of 1 to 5, with a higher score indicating greater self-efficacy to reduce sex-related HIV-risk behavior."|Immediately Post-Intervention, at 4 weeks|||units on a scale||Standard Error|Mean
667295|NCT01741350|Primary|Self-efficacy to Reduce Sex-related HIV- Risk Behavior (1-5)|"Participants completed a questionnaire assessing their self-efficacy about reducing sex-related HIV-risk behavior (e.g., If asked, I am confident I could demonstrate how to use male condom and female condoms correctly) and were rated on a scale of 1 to 5, with a higher score indicating greater self-efficacy to reduce sex-related HIV-risk behavior."|Baseline|||units on a scale||Standard Error|Mean
667296|NCT01741350|Primary|Social Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)|"Participants completed a questionnaire assessing their social motivation to reduce sex-related HIV-risk behavior (e.g., Most people who are important to me think I should always use condoms during sexual intercourse in the next three months) and were rated on a scale of 1 to 5, with a higher score indicating stronger social motivation to reduce HIV-risk behavior."|12-month follow up|||units on a scale||Standard Error|Mean
667297|NCT01741350|Primary|Social Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)|"Participants completed a questionnaire assessing their social motivation to reduce sex-related HIV-risk behavior (e.g., Most people who are important to me think I should always use condoms during sexual intercourse in the next three months) and were rated on a scale of 1 to 5, with a higher score indicating stronger social motivation to reduce HIV-risk behavior."|6-month follow up|||units on a scale||Standard Error|Mean
667298|NCT01741350|Primary|Social Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)|"Participants completed a questionnaire assessing their social motivation to reduce sex-related HIV-risk behavior (e.g., Most people who are important to me think I should always use condoms during sexual intercourse in the next three months) and were rated on a scale of 1 to 5, with a higher score indicating stronger social motivation to reduce HIV-risk behavior."|3-month follow up|||units on a scale||Standard Error|Mean
667299|NCT01741350|Primary|Social Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)|"Participants completed a questionnaire assessing their social motivation to reduce sex-related HIV-risk behavior (e.g., Most people who are important to me think I should always use condoms during sexual intercourse in the next three months) and were rated on a scale of 1 to 5, with a higher score indicating stronger social motivation to reduce HIV-risk behavior."|Immediately Post-Intervention, at 4 weeks|||units on a scale||Standard Error|Mean
667300|NCT01741350|Primary|Social Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)|"Participants completed a questionnaire assessing their social motivation to reduce sex-related HIV-risk behavior (e.g., Most people who are important to me think I should always use condoms during sexual intercourse in the next three months) and were rated on a scale of 1 to 5, with a higher score indicating stronger social motivation to reduce HIV-risk behavior."|Baseline|||units on a scale||Standard Error|Mean
667301|NCT01741350|Primary|Personal Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)|"Participants completed a questionnaire assessing their personal motivation to reduce sex-related HIV-risk behavior (e.g., Always using condoms during sexual intercourse during the next three months would be good) and were rated on a scale of 1 to 5, with a higher score indicating greater personal motivation to reduce HIV-risk behavior."|12-month follow up|||units on a scale||Standard Error|Mean
667302|NCT01741350|Primary|Personal Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)|"Participants completed a questionnaire assessing their personal motivation to reduce sex-related HIV-risk behavior (e.g., Always using condoms during sexual intercourse during the next three months would be good) and were rated on a scale of 1 to 5, with a higher score indicating greater personal motivation to reduce HIV-risk behavior."|6-month follow up|||units on a scale||Standard Error|Mean
667303|NCT01741350|Primary|Personal Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)|"Participants completed a questionnaire assessing their personal motivation to reduce sex-related HIV-risk behavior (e.g., Always using condoms during sexual intercourse during the next three months would be good) and were rated on a scale of 1 to 5, with a higher score indicating greater personal motivation to reduce HIV-risk behavior."|3-month follow up|||units on a scale||Standard Error|Mean
667304|NCT01741350|Primary|Personal Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)|"Participants completed a questionnaire assessing their personal motivation to reduce sex-related HIV-risk behavior (e.g., Always using condoms during sexual intercourse during the next three months would be good) and were rated on a scale of 1 to 5, with a higher score indicating greater personal motivation to reduce HIV-risk behavior."|Immediately Post-Intervention, at 4 weeks|||units on a scale||Standard Error|Mean
667305|NCT01741350|Primary|Personal Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)|"Participants completed a questionnaire assessing their personal motivation to reduce sex-related HIV-risk behavior (e.g., Always using condoms during sexual intercourse during the next three months would be good) and were rated on a scale of 1 to 5, with a higher score indicating greater personal motivation to reduce HIV-risk behavior."|Baseline|||units on a scale||Standard Error|Mean
667306|NCT01741350|Primary|Sex-related HIV-risk Reduction Knowledge (0-1)|"Participants' knowledge of sex-related HIV-risk reduction was assessed by being asked: If an HIV positive person only has sex with another HIV positive person, they don't need to use condoms and rated on a scale of 0 to 1, with a higher score indicating greater HIV-risk reduction knowledge."|12-month follow up|||units on a scale||Standard Error|Mean
667307|NCT01741350|Primary|Sex-related HIV-risk Reduction Knowledge (0-1)|"Participants' knowledge of sex-related HIV-risk reduction was assessed by being asked: If an HIV positive person only has sex with another HIV positive person, they don't need to use condoms and rated on a scale of 0 to 1, with a higher score indicating greater HIV-risk reduction knowledge."|6-month follow up|||units on a scale||Standard Error|Mean
667308|NCT01741350|Primary|Sex-related HIV-risk Reduction Knowledge (0-1)|"Participants' knowledge of sex-related HIV-risk reduction was assessed by being asked: If an HIV positive person only has sex with another HIV positive person, they don't need to use condoms and rated on a scale of 0 to 1, with a higher score indicating greater HIV-risk reduction knowledge."|3-month follow up|||units on a scale||Standard Error|Mean
667309|NCT01741350|Primary|Sex-related HIV-risk Reduction Knowledge (0-1)|"Participants' knowledge of sex-related HIV-risk reduction was assessed by being asked: If an HIV positive person only has sex with another HIV positive person, they don't need to use condoms and rated on a scale of 0 to 1, with a higher score indicating greater HIV-risk reduction knowledge."|Immediately Post-Intervention, at 4 weeks|||units on a scale||Standard Error|Mean
667310|NCT01741350|Primary|Sex-related HIV-risk Reduction Knowledge (0-1)|"Participants' knowledge of sex-related HIV-risk reduction was assessed by being asked: If an HIV positive person only has sex with another HIV positive person, they don't need to use condoms and rated on a scale of 0 to 1, with a higher score indicating greater HIV-risk reduction knowledge."|Baseline|||units on a scale||Standard Error|Mean
667311|NCT01741350|Primary|Condom Use (0-4)|"Participants were asked: In the past week, how much of the time did you use a condom or other latex protection when you had oral, anal, or vaginal sex? and rated on scale of 0 to 4, with indicating greater condom use."|12-month follow up|||units on a scale||Standard Error|Mean
667312|NCT01741350|Primary|Condom Use (0-4)|"Participants were asked: In the past week, how much of the time did you use a condom or other latex protection when you had oral, anal, or vaginal sex? and rated on scale of 0 to 4, with indicating greater condom use."|6-month follow up|||units on a scale||Standard Error|Mean
667313|NCT01741350|Primary|Condom Use (0-4)|"Participants were asked: In the past week, how much of the time did you use a condom or other latex protection when you had oral, anal, or vaginal sex? and rated on scale of 0 to 4, with indicating greater condom use."|3-month follow up|||units on a scale||Standard Error|Mean
667314|NCT01741350|Primary|Condom Use (0-4)|"Participants were asked: In the past week, how much of the time did you use a condom or other latex protection when you had oral, anal, or vaginal sex? and rated on scale of 0 to 4, with indicating greater condom use."|Immediately Post-Intervention, at 4 weeks|||units on a scale||Standard Error|Mean
667315|NCT01741350|Primary|Condom Use (0-4)|"Participants were asked: In the past week, how much of the time did you use a condom or other latex protection when you had oral, anal, or vaginal sex? and rated on scale of 0 to 4, with indicating greater condom use."|Baseline|||units on a scale||Standard Error|Mean
667316|NCT01741350|Primary|Male Condom Skills (0-100%)|Participants' HIV risk reduction behavioral skills were assessed based on the percentage of correct necessary steps demonstrated to properly select and apply a male condom using a replica.|12-month follow up|||percentage of correct steps||Standard Error|Mean
667317|NCT01741350|Primary|Male Condom Skills (0-100%)|Participants' HIV risk reduction behavioral skills were assessed based on the percentage of correct necessary steps demonstrated to properly select and apply a male condom using a replica.|6-month follow up|||percentage of correct steps||Standard Error|Mean
667318|NCT01741350|Primary|Male Condom Skills (0-100%)|Participants' HIV risk reduction behavioral skills were assessed based on the percentage of correct necessary steps demonstrated to properly select and apply a male condom using a replica.|3-month follow up|||percentage of correct steps||Standard Error|Mean
667319|NCT01741350|Primary|Male Condom Skills (0-100%)|Participants' HIV risk reduction behavioral skills were assessed based on the percentage of correct necessary steps demonstrated to properly select and apply a male condom using a replica.|Immediately Post-Intervention, at 4 weeks|||percentage of correct steps||Standard Error|Mean
667320|NCT01741350|Primary|Male Condom Skills (0-100%)|Participants' HIV risk reduction behavioral skills were assessed based on the percentage of correct necessary steps demonstrated to properly select and apply a male condom using a replica.|Baseline|||percentage of correct steps||Standard Error|Mean
667321|NCT01741350|Primary|Female Condom Skills (0-100%)|Participants' HIV risk reduction behavioral skills were assessed based on the percentage of correct necessary steps demonstrated to properly select and apply a female condom using a replica.|12-month follow up|||percentage of correct steps||Standard Error|Mean
667322|NCT01741350|Primary|Female Condom Skills (0-100%)|Participants' HIV risk reduction behavioral skills were assessed based on the percentage of correct necessary steps demonstrated to properly select and apply a female condom using a replica.|6-month follow up|||percentage of correct steps||Standard Error|Mean
667323|NCT01741350|Primary|Female Condom Skills (0-100%)|Participants' HIV risk reduction behavioral skills were assessed based on the percentage of correct necessary steps demonstrated to properly select and apply a female condom using a replica.|3-month follow up|||percentage of correct steps||Standard Error|Mean
667326|NCT01741350|Primary|Self-efficacy to Reduce Drug-related HIV-Risk Behavior (1-5)|"Participants completed a questionnaire assessing their self-efficacy about reducing HIV risk behavior (e.g., How hard would it be for you to always use condoms) and rated on a scale of 1 to 5, with higher scores indicating greater self-efficacy to reduce HIV-risk behavior."|12-month follow up|||units on a scale||Standard Error|Mean
667327|NCT01741350|Primary|Self-efficacy to Reduce Drug-related HIV-Risk Behavior (1-5)|"Participants completed a questionnaire assessing their self-efficacy about reducing HIV risk behavior (e.g., How hard would it be for you to always use condoms) and rated on a scale of 1 to 5, with higher scores indicating greater self-efficacy to reduce HIV-risk behavior."|6-month follow up|||units on a scale||Standard Error|Mean
667328|NCT01741350|Primary|Self-efficacy to Reduce Drug-related HIV-Risk Behavior (1-5)|"Participants completed a questionnaire assessing their self-efficacy about reducing HIV risk behavior (e.g., How hard would it be for you to always use condoms) and rated on a scale of 1 to 5, with higher scores indicating greater self-efficacy to reduce HIV-risk behavior."|3-month follow up|||units on a scale||Standard Error|Mean
667329|NCT01741350|Primary|Self-efficacy to Reduce Drug-related HIV-Risk Behavior (1-5)|"Participants completed a questionnaire assessing their self-efficacy about reducing HIV risk behavior (e.g., How hard would it be for you to always use condoms) and rated on a scale of 1 to 5, with higher scores indicating greater self-efficacy to reduce HIV-risk behavior."|Immediately Post-Intervention, at 4 weeks|||units on a scale||Standard Error|Mean
667330|NCT01741350|Primary|Self-efficacy to Reduce Drug-related HIV-Risk Behavior (1-5)|"Participants completed a questionnaire assessing their self-efficacy about reducing HIV risk behavior (e.g., How hard would it be for you to always use condoms) and rated on a scale of 1 to 5, with higher scores indicating greater self-efficacy to reduce HIV-risk behavior."|Baseline|||units on a scale||Standard Error|Mean
667331|NCT01741350|Primary|Social Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)|"Participants completed a questionnaire assessing their social motivation to reduce HIV risk behavior (e.g., Most people who are important to me think I should always clean my needles before I share them with someone else during the next three months) and rated on a scale of 1 to 5, with higher scores indicating stronger social motivation to reduce HIV-risk behavior."|12-month follow up|||units on a scale||Standard Error|Mean
667332|NCT01741350|Primary|Social Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)|"Participants completed a questionnaire assessing their social motivation to reduce HIV risk behavior (e.g., Most people who are important to me think I should always clean my needles before I share them with someone else during the next three months) and rated on a scale of 1 to 5, with higher scores indicating stronger social motivation to reduce HIV-risk behavior."|6-month follow up|||units on a scale||Standard Error|Mean
667333|NCT01741350|Primary|Social Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)|"Participants completed a questionnaire assessing their social motivation to reduce HIV risk behavior (e.g., Most people who are important to me think I should always clean my needles before I share them with someone else during the next three months) and rated on a scale of 1 to 5, with higher scores indicating stronger social motivation to reduce HIV-risk behavior."|3-month follow up|||units on a scale||Standard Error|Mean
667334|NCT01741350|Primary|Social Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)|"Participants completed a questionnaire assessing their social motivation to reduce HIV risk behavior (e.g., Most people who are important to me think I should always clean my needles before I share them with someone else during the next three months) and rated on a scale of 1 to 5, with higher scores indicating stronger social motivation to reduce HIV-risk behavior."|Immediately Post-Intervention, at 4 weeks|||units on a scale||Standard Error|Mean
667335|NCT01741350|Primary|Social Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)|"Participants completed a questionnaire assessing their social motivation to reduce HIV risk behavior (e.g., Most people who are important to me think I should always clean my needles before I share them with someone else during the next three months) and rated on a scale of 1 to 5, with higher scores indicating stronger social motivation to reduce HIV-risk behavior."|Baseline|||units on a scale||Standard Error|Mean
667336|NCT01741350|Primary|Personal Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)|"Participants completed a questionnaire assessing their personal motivation to reduce HIV risk behavior (e.g., I plan to always use clean needles if I shoot up drugs during the next six months) and rated on a scale of 1 to 5, with higher scores indicating stronger motivation to reduce HIV-risk behavior."|12-month follow up|||units on a scale||Standard Error|Mean
667337|NCT01741350|Primary|Personal Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)|"Participants completed a questionnaire assessing their personal motivation to reduce HIV risk behavior (e.g., I plan to always use clean needles if I shoot up drugs during the next six months) and rated on a scale of 1 to 5, with higher scores indicating stronger motivation to reduce HIV-risk behavior."|6-month follow up|||units on a scale||Standard Error|Mean
667338|NCT01741350|Primary|Personal Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)|"Participants completed a questionnaire assessing their personal motivation to reduce HIV risk behavior (e.g., I plan to always use clean needles if I shoot up drugs during the next six months) and rated on a scale of 1 to 5, with higher scores indicating stronger motivation to reduce HIV-risk behavior."|3-month follow up|||units on a scale||Standard Error|Mean
667339|NCT01741350|Primary|Personal Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)|"Participants completed a questionnaire assessing their personal motivation to reduce HIV risk behavior (e.g., I plan to always use clean needles if I shoot up drugs during the next six months) and rated on a scale of 1 to 5, with higher scores indicating stronger motivation to reduce HIV-risk behavior."|Immediately Post-Intervention, at 4 weeks|||units on a scale||Standard Error|Mean
667340|NCT01741350|Primary|Personal Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)|"Participants completed a questionnaire assessing their personal motivation to reduce HIV risk behavior (e.g., I plan to always use clean needles if I shoot up drugs during the next six months) and rated on a scale of 1 to 5, with higher scores indicating stronger motivation to reduce HIV-risk behavior."|Baseline|||units on a scale||Standard Error|Mean
667341|NCT01741350|Primary|Drug-related HIV-risk Reduction Knowledge (0-1)|"Participants completed an assessment that covers information about drug-related HIV-risk reduction (e.g.,If an HIV+ person shared needles with another HIV+ person, they don't need to clean the needles)."|12-month follow up|||units on a scale||Standard Error|Mean
667342|NCT01741350|Primary|Drug-related HIV-risk Reduction Knowledge (0-1)|"Participants completed an assessment that covers information about drug-related HIV-risk reduction (e.g.,If an HIV+ person shared needles with another HIV+ person, they don't need to clean the needles) and were rated on a scale of 0 to 1 (higher values representing greater risk reduction knowledge)."|6-month follow up|||units on a scale||Standard Error|Mean
667343|NCT01741350|Primary|Drug-related HIV-risk Reduction Knowledge (0-1)|"Participants completed an assessment that covers information about drug-related HIV-risk reduction (e.g.,If an HIV+ person shared needles with another HIV+ person, they don't need to clean the needles) and were rated on a scale of 0 to 1 (higher values representing greater risk reduction knowledge)."|3-month follow up|||units on a scale||Standard Error|Mean
667344|NCT01741350|Primary|Drug-related HIV-risk Reduction Knowledge (0-1)|"Participants completed an assessment that covers information about drug-related HIV-risk reduction (e.g.,If an HIV+ person shared needles with another HIV+ person, they don't need to clean the needles) and were rated on a scale of 0 to 1 (higher values representing greater risk reduction knowledge)."|Immediately Post-Intervention, at 4 weeks|||units on a scale||Standard Error|Mean
667345|NCT01741350|Primary|Drug-related HIV-risk Reduction Knowledge (0-1)|"Participants completed an assessment that covers information about drug-related HIV-risk reduction (e.g.,If an HIV+ person shared needles with another HIV+ person, they don't need to clean the needles) and were rated on a scale of 0 to 1 (higher values representing greater risk reduction knowledge)."|Baseline|||units on a scale||Standard Error|Mean
667346|NCT01741350|Primary|Safer Drug Use (0-4)|Participants completed a self-reported assessment that asks about IV-sharing behavior and were assessed on a scale of 0–4, with higher scores indicating safer drug use.|12-month follow up|||units on a scale||Standard Error|Mean
667347|NCT01741350|Primary|Safer Drug Use (0-4)|Participants completed a self-reported assessment that asks about IV-sharing behavior and were assessed on a scale of 0–4, with higher scores indicating safer drug use.|6-month follow up|||units on a scale||Standard Error|Mean
667348|NCT01741350|Primary|Safer Drug Use (0-4)|Participants completed a self-reported assessment that asks about IV-sharing behavior and were assessed on a scale of 0–4, with higher scores indicating safer drug use.|3-month follow up|||units on a scale||Standard Error|Mean
667349|NCT01741350|Primary|Safer Drug Use (0-4)|Participants completed a self-reported assessment that asks about IV-sharing behavior and were assessed on a scale of 0–4, with higher scores indicating safer drug use.|Immediately Post-Intervention, at 4 weeks|||units on a scale||Standard Error|Mean
667350|NCT01741350|Primary|Safer Drug Use (0-4)|Participants completed a self-reported assessment that asks about IV-sharing behavior and were assessed on a scale of 0–4, with higher scores indicating safer drug use.|Baseline|||units on a scale||Standard Error|Mean
667351|NCT01741350|Primary|Demonstrated Drug Risk Reduction Skills (0-100%)|Participants' HIV risk reduction skills were assessed by having participants demonstrate the steps necessary to properly clean a needle/syringe.|12-month follow up|||Percentage of correct steps||Standard Error|Mean
667352|NCT01741350|Primary|Demonstrated Drug Risk Reduction Skills (0-100%)|Participants' HIV risk reduction skills were assessed by having participants demonstrate the steps necessary to properly clean a needle/syringe.|6-month follow up|||Percentage of correct steps||Standard Error|Mean
667353|NCT01741350|Primary|Demonstrated Drug Risk Reduction Skills (0-100%)|Participants' HIV risk reduction skills were assessed by having participants demonstrate the steps necessary to properly clean a needle/syringe.|3-month follow up|||Percentage of correct steps||Standard Error|Mean
667354|NCT01741350|Primary|Demonstrated Drug Risk Reduction Skills (0-100%)|Participants' HIV risk reduction skills were assessed by having participants demonstrate the steps necessary to properly clean a needle/syringe.|Immediately Post-Intervention, at 4 weeks|||Percentage of correct steps||Standard Error|Mean
667355|NCT01741350|Primary|Demonstrated Drug Risk Reduction Skills (0-100%)|Participants' HIV risk reduction skills were assessed by having participants demonstrate the steps necessary to properly clean a needle/syringe.|Baseline|||Percentage of correct steps||Standard Error|Mean
667356|NCT01741272|Secondary|Complications|Incidence of any surgical or medical complications will be prospectively documented.|2 & 6 weeks, 3, 6, 12, 24 months|37 subjects (17 Early Mobilization, 20 Standard Rehabilitation) had non-re-tear complications. 5 subjects reported more than one complication.||participants|||Number
667357|NCT01741272|Secondary|Abduction Strength Using the Power Component of the Constant Score|The Constant Score is the most widely used shoulder evaluation questionnaire in Europe and is a shoulder specific instrument. The score is a combination of an objective physical examination (65 points) and a subjective patient self evaluation (35 points). The physical examination component includes a range of motion assessment (forward elevation, lateral elevation, internal rotation, and external rotation) worth a total of 40 points (maximum of 10 points for each motion). The remaining 25 points are attributed to the strength assessment, where patients are awarded one point for each pound of pull that the patient can resist in abduction. Therefore the total possible score on the Constant score is 100 points (best possible score = 100. In this case only the power component was used therefore the best score is 25.|Baseline, 24 months|||units on a scale||Inter-Quartile Range|Mean
667358|NCT01741272|Secondary|WORC Questionnaire|Health related quality of life was measured using the Western Ontario Rotator Cuff Index (WORC). It is a 21-item disease specific questionnaire representing five quality of life domains (physical symptoms, sports and recreation, work, lifestyle and emotions). Each response is marked on a 100mm line in a VAS format with a maximum raw score of 2100, where zero represents the best and 2100 the worst score. This score is transformed to a 0-100 format, with 100 representing full shoulder function.|Baseline, 6, 12, 24 months|||units on a scale||Inter-Quartile Range|Mean
667359|NCT01741272|Secondary|Pain Questionnaire|Shoulder pain was assessed using a visual analogue scale (VAS) where zero equals no pain and 10 is the worst possible pain at rest and with activity. Two-way repeated-measures analysis of variance (ANOVA) compared pain between groups over time.|Baseline, 2 weeks, 6 weeks, 3, 6, 12, 24 months|||centimeters||Standard Deviation|Mean
667380|NCT01740713|Primary|AUC (0-8h)|Area under concentration versus time curve from 0 to 8 h post dosing. Secondary pharmacokinetic parameter derived on the basis of the individual predicted concentration vs. time profiles, through the pop-PK model.|Day 1 of single dose treatment (6 sampling time range: from predose up to 8h post first administration)|||micromol*h/L||Inter-Quartile Range|Median
667360|NCT01741272|Primary|Change in Range of Motion (ROM)From Baseline to 24 Months|"Two-way repeated-measures analysis of variance (ANOVA) compared shoulder ROM between groups over time. Standing: Active flexion, scaption, abduction, extension, internal rotation (vertebral level).
Supine Lying: Active and passive flexion, abduction, external rotation (arm at side), external rotation (arm at 90 degrees abduction), internal rotation (arm at side), internal rotation (arm at 90 degrees abduction),and horizontal adduction."|Baseline, 6 weeks, 3, 6, 12, 24 months|||degrees||Standard Deviation|Mean
667361|NCT01740817|Secondary|Extracellular Signal-regulated Kinase (ERK) Phosphorylation in Muscle|Forty eight hrs after lipid or saline infusion, muscle ERK phosphorylation will be measured by western blot. The results are compared to determine whether lipid infusion increases muscle ERK phosphorylation compared to saline infusion. Saline mean was used to normalize the data for both arms.|48 hr following lipid or saline infusion, pre-clamp|||densitometry value||Standard Error|Mean
667362|NCT01740817|Secondary|TLR4 Messenger Ribonucleic Acid (mRNA) in Muscle|"Forty eight hrs after lipid or saline infusion, muscle TLR4 mRNA levels will be measured by RT-PCR. The results are compared to determine whether lipid infusion increases muscle TLR4 mRNA expression compared to saline infusion.
Saline mean was used to normalize the data for both arms."|48 hr following lipid/saline infusion, pre-clamp|||ng TLR4 mRNA/ng Actin mRNA||Standard Error|Mean
667363|NCT01740817|Primary|Muscle Insulin Sensitivity-M Value|"Forty eight hrs after lipid or saline infusion, muscle insulin sensitivity will be measured by insulin clamp. The results are compared to determine whether lipid infusion reduces muscle insulin sensitivity compared to saline infusion..
The M value is defined as the exogenous glucose infusion rate at steady state (i.e, when the exogenous glucose infusion rate is equal to the rate of whole body glucose disposal)."|48 hr after lipid/saline infusion|||mg/kg.min||Standard Error|Mean
667364|NCT01740726|Other Pre-specified|Child's Behavior Checklist - Parent Version (CBCL-P)|Completed by parents to describe the child’s behavioral and emotional difficulties. Scores reflect observed problems and level of adaptive functioning.|18 wks., 30 wks., 42 wks.||||||
667365|NCT01740726|Other Pre-specified|Adolescent Longitudinal Interval Follow-up Evaluation (A-LIFE)|Semi-structured interview that assesses psychiatric symptoms, treatments, and functional outcomes in the time period that has elapsed since the previous assessment and tracks change over time.|18 wks., 30 wks, 42 wks||||||
667366|NCT01740726|Secondary|Change in Hope Based on Children's Hope Scale (CHS)|Assesses self-perception of ability to set and work toward goals.|Baseline, 9 wks., 18 wks., 30 wks., 42 wks.||||||
667367|NCT01740726|Secondary|Change in Suicidal Ideation Based on Suicidal Ideation Questionnaire (SIQ)|Assesses seriousness of suicidal intent.|Baseline, 9 wks., 18 wks., 30 wks., 42 wks.||||||
667368|NCT01740726|Secondary|Change in Anxiety From Baseline Based on Multidimensional Anxiety Scale for Children (MASC)|Measures anxiety symptom severity.|Baseline, 9 wks., 18 wks., 30 wks., 42 wks.||||||
667369|NCT01740726|Secondary|Change in Behaviors From Baseline Based on Behavioral Activation for Depression Scale (BADS)|Assesses behavioral changes on 4 subscales: Activation, Avoidance/Rumination, Work/School Impairment, and Social Impairment.|Baseline, 9 wks., 18 wks., 30 wks., 42 wks.||||||
667370|NCT01740726|Secondary|Overall Improvement and Change in Symptom Severity From Baseline Based on Clinical Global Impression - Improvement and Severity (CGI-I, CGI-S)|Clinician's rating of symptom severity and improvement since baseline.|Baseline, 9 wks., 18 wks., 30 wks., 42 wks.||||||
667371|NCT01740726|Primary|Change in Depressive Symptoms From Baseline Based on Children's Depression Rating Scale - Revised (CDRS-R)|Interview-based measure, completed with both the parent and child, that assesses depression severity.|Baseline, 9 wks., 18 wks., 30 wks., 42 wks.||||||
667372|NCT01740726|Primary|Change in Depressive Symptoms From Baseline Based on Beck Depression Inventory, 2nd Edition (BDI-II)|Self-report measure, completed by the child, that assesses depressive symptom severity. The BDI-II total score ranges from 0 to 63, with a higher score indicating a higher level of depression. Change is the difference between the 42 week score and the baseline score.|Baseline, 42 weeks|||units on a scale|||Number
667373|NCT01740713|Secondary|Adverse Events|All the medical occurrences that started after the administration of the drug|from drug administration up to 8 days post treatment|||participants|||Number
667374|NCT01740713|Primary|Cmin|Minimum plasma concentration. Secondary pharmacokinetic parameter derived on the basis of the individual predicted concentration vs. time profiles, through the pop-PK model.|Day 1 of single dose treatment (6 sampling time range: from predose up to 8h post first administration)|||microM||Inter-Quartile Range|Median
667375|NCT01740713|Primary|Css|Plasma concentration reached at steady state. Secondary pharmacokinetic parameter derived on the basis of the individual predicted concentration vs. time profiles, through the pop-PK model.|Day 1 of single dose treatment (6 sampling time range: from predose up to 8h post first administration)|||microM||Inter-Quartile Range|Median
667376|NCT01740713|Primary|Cmax|Maximum concentration reached in plasma. Secondary pharmacokinetic parameter derived on the basis of the individual predicted concentration vs. time profiles, through the pop-PK model.|Day 1 of single dose treatment (6 sampling time range: from predose up to 8h post first administration)|||microM||Inter-Quartile Range|Median
667377|NCT01740713|Primary|Ka|Absorption rate constant. The parameter was estimated through a population pharmacokinetic model, during which concentration data obtained after single oral dose ( at 3 dose levels) of DFP in patients aged from 1 month to less than 6 years of age.|Day 1 of single dose treatment (6 sampling time range: from predose up to 8h post first administration)|||h^-1||Standard Error|Mean
667378|NCT01740713|Primary|Tmax|Time at which the maximum concentration (Cmax) is reached. Secondary pharmacokinetic parameters such as Cmax, Min, Tmax, Css and AUC (0-8h) were derived based on the individual predicted concentration vs. time profiles.|Day 1 of single dose treatment (6 sampling time range: from predose up to 8h post first administration)|||hour||Inter-Quartile Range|Median
667379|NCT01740713|Primary|V/F|volume of distribution after oral administration. The parameter was estimated through a population pharmacokinetic model, during which concentration data obtained after single oral dose ( at 3 dose levels) of DFP in patients aged from 1 month to less than 6 years of age|Day 1 of single dose treatment (6 sampling time range: from predose up to 8h post first administration)|||litres||Standard Error|Mean
667409|NCT01740388|Primary|Clinical Resolution|Absence of both conjunctival discharge and bulbar conjunctival injection, after 3 days of treatment with besifloxacin ophthalmic suspension 0.6%|Visit 2 (Day 4 or 5)|Analysis population is only Subjects with non-missing data, Clinical Resolution (LOCF [Last Observation Carried Forward])||participants|||Number
667381|NCT01740713|Primary|CL/F|Plasma clearance after oral administration. The parameter was estimated through a population pharmacokinetic model, during which concentration data obtained after single oral dose ( at 3 dose levels) of DFP in patients aged from 1 month to less than 6 years of age.|Day 1 of single dose treatment (6 sampling time range: from predose up to 8h post first administration)|||litre/h||Standard Error|Mean
667382|NCT01740440|Secondary|To Evaluate the Subject’s Satisfaction With BMR Face Treatment at 6 Weeks and 12 Weeks (Subject Self- Assessment).|The Subject Satisfaction Assessment Scale is a 5 point scale where a subject rates their satisfaction level as Very Satisfied, Satisfied, No Opinion, Unsatisfied or Very Unsatisfied.|6 weeks, 12 weeks|23 out of 30 subjects that were enrolled in the study were statistically analyzed. 3 subjects were lost to follow-up and 4 subjects had to be excluded from analysis due to protocol violations||percentage of subjects|||Number
667383|NCT01740440|Secondary|To Evaluate Overall Facial Improvement Assessed Live by the Investigator and Subjects Including the Global Aesthetic Improvement Scale (GAIS) at 6 Weeks Compared to Baseline|"Evaluate the efficacy of the Efficacy will be assessed by overall facial improvement assessed live by the Investigator and a subject assessment of facial appearance including the Global Aesthetic Improvement Scale (GAIS).
The Global Aesthetic Improvement Scale is a five-grade subjective test. The physician and patient independently describe the degree of improvement in facial appearance. Possible responses were (1) Significantly marked improvement, (2) marked improvement, (3) moderate improvement, (4) slight improvement, (5) no improvement.
For reporting of outcomes, the higher the GAIS value, the greater the improvement (Range 0-4)."|6 weeks|23 out of 30 subjects that were enrolled in the study were statistically analyzed. 3 subjects were lost to follow-up and 4 subjects had to be excluded from analysis due to protocol violations||units on a scale||Full Range|Mean
667384|NCT01740440|Primary|Evaluate Overall Facial Improvement Assessed Live by the Investigator and Subjects Using the Global Aesthetic Improvement Scale (GAIS) at 12 Weeks Compared to Baseline.|"Evaluate the efficacy of the Efficacy will be assessed by overall facial improvement assessed live by the Investigator and a subject assessment of facial appearance including the Global Aesthetic Improvement Scale (GAIS).
The Global Aesthetic Improvement Scale is a five-grade subjective test. The physician and patient independently describe the degree of improvement in facial appearance. Possible responses were (1) Significantly marked improvement, (2) marked improvement, (3) moderate improvement, (4) slight improvement, (5) no improvement.
For reporting of outcomes, the higher the GAIS value, the greater the improvement (Range 0-4)."|12 weeks|23 out of 30 subjects that were enrolled in the study were statistically analyzed. 3 subjects were lost to follow-up and 4 subjects had to be excluded from analysis due to protocol violations.||Scores on a Scale||Full Range|Mean
667407|NCT01740388|Secondary|Clinical Resolution|Absence of both conjunctival discharge and bulbar conjunctival injection, after 3 days of treatment with besifloxacin ophthalmic suspension 0.6%|Visit 3 (Day 6, 7, or 8)|Analysis population is only Subjects with non-missing data, Clinical Resolution (LOCF [Last Observation Carried Forward])||participants|||Number
667408|NCT01740388|Primary|Microbial Eradication|Absence of all accepted ocular bacterial species that were present at or above threshold at baseline, after 3 days of treatment with besifloxacin ophthalmic suspension 0.6%|Visit 2 (Day 4 or 5)|Analysis population is only Subjects with non-missing data, Microbial Eradication (LOCF [Last Observation Carried Forward])||participants|||Number
667484|NCT01738698|Primary|Change From Baseline in Negative Symptom Assessment - 16-item (NSA-16) Total Score at 12 Weeks||Baseline and 12 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
667397|NCT01740414|Other Pre-specified|Pain Intensity|15-item shortened form of the McGill Pain Questionnaire (Melzack, 1987) that is used to assess the sensory and affective dimensions of the pain experienced Participants describe their experience of pain by choosing among a series of possible answers (None [score=1], Mild [score=2], Moderate [score=3], or Severe [score=4]). They were asked to describe the pain as “Throbbing,” “Shooting,” “Stabbing,” “Sharp,” “Cramping,” “Gnawing,” “Hot-Burning,” “Aching,” “Heavy,” “Tender,” “Splitting,” “Tired-Exhausting,” “Sickening,” “Fearful,” and “Punishing-Cruel.” Scores were added across all 15 items to generate a sum score, which ranged between 15 and 60.|42 days|||units on a scale||Standard Error|Mean
667398|NCT01740414|Secondary|Positive Subjective Effects to Oxycodone|"Participants are shown a 100-mm line and asked to indicate on that line the extent to which they agree with the descriptor of the drug effect such as Liking/Liked the Drug. On this visual analog scale participants were instructed that the Left/ 0 mm point on the line represents not at all, while the right/100 mm point represents “Extremely.”"|42 days|||units on a scale||Standard Deviation|Mean
667399|NCT01740414|Primary|Drug Self-administration Breakpoint|Participants are allowed to perform an operant task (click on a mouse) in order to receive a dose drug under investigation (oxycodone dose 0 mg, 15 mg, or 30 mg). The drug breakpoint is the maximum number of responses (mouse clicks) the participant was willing to make to receive the drug. Within the context of abuse liability studies, larger breakpoints represent greater abuse potential of a drug.|42 days|||Clicks on a computer mouse||Standard Error|Mean
667400|NCT01740401|Secondary|T Regulatory Cell Profile in Peripheral Blood|Peripheral blood taken at baseline/various therapeutic time points/possibly maintenance cycles to evaluate T regulatory cells identified, serially monitored by polychromatic flow cytometry using FoxP3+/CD4+/CD127low/CD25hi markers.|Week 60|Primary Endpoint not met, study terminated, data not collected|||||
667401|NCT01740401|Other Pre-specified|Tumor-specific T Cell Responses Will be Measured in a Subset of Patients Who Have Biopsy Accessible Tumor and Have Tumor Biopsies Taken.|One of the tumor punch biopsy will be put in formalin for paraffin-embedding. The other tumor punch biopsy will be processed to obtain lysates to be used as antigens for the T cell assays. Two tumor punch biopsies (4mm in diameter) will be obtained before and after therapy (baseline and week 12, and optional during weeks 24, 36, and 48) if patients have accessible tumors.|Week 48|Primary Endpoint not met, study terminated, data not collected|||||
667402|NCT01740401|Secondary|Progression-free Survival|Progression-free survival is measured from date of entry to date of 1st documented evidence of recurrence, confirmation of PD, or death (whichever is 1st). T regulatory cells are measured on D1 (pre CTX) & D3 of each cycle.|Week 60|Primary Endpoint not met, study terminated, data not collected|||||
667403|NCT01740401|Primary|The Primary Objective of This Study is: Evaluate the Anti-tumor Activity of the Combination of Low Dose Cyclophosphamide and CTLA-4 Blockade Using Objective Response Rate (ORR) by 12 Weeks Following mWHO RC.|Objective response rate (ORR) using mWHO RC 2-stage design – 10 patients will be enrolled in Stage 1. The primary endpoint will be assessed when 10 patients have been followed for 12 weeks. In order to continue the study uninterrupted, additional patients will be enrolled in Stage 2 of the study, provided that safety does not become an issue. However, it is estimated that no more than 6 patients will be enrolled before the primary endpoint can be assessed in the initial 10 patients of the study.|12 weeks|||Participants|||Count of Participants
667404|NCT01740388|Other Pre-specified|Bulbar Conjunctival Injection|Bulbar conjunctival injection measured on a scale of 0-3 where 0 = Normal, 1 = Mild, 2 = Moderate and 3 = Severe|At each follow-up visit (Visit 1, Visit 2 and Visit 3)|||participants|||Number
667405|NCT01740388|Other Pre-specified|Ocular Conjunctival Discharge|Ocular conjunctival discharge measures on a scale of 0-3 where 0 = Absent, 1 = Mild, 2 = Moderate and 3 = Severe|At each follow-up visit (Visit 1, Visit 2 and Visit 3)|Analysis population is only Subjects with non-missing data, Ocular Discharge Evaluated on the Baseline-Designated Study Eye||participants|||Number
667406|NCT01740388|Secondary|Microbial Eradication|Absence of all accepted ocular bacterial species that were present at or above threshold at baseline, after 3 days of treatment with besifloxacin ophthalmic suspension 0.6%|Visit 3 (Day 6, 7, or 8)|||participants|||Number
667410|NCT01740362|Primary|Renal Clearance (CL R)|Renal clearance is the volume of plasma from which the drug is completely removed by the kidney in a given amount of time.|0 (Pre-dose) to 12 hours post-dose, 12 to 24 hours post-dose|Analysis set included all participants who received study medication.||mL/min||Standard Deviation|Mean
667411|NCT01740362|Primary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (Pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10, 12, 16, 24, 48 hours post-dose|Analysis set included all participants who received study medication.||hours||Standard Deviation|Mean
667412|NCT01740362|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 (Pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10, 12, 16, 24, 48 hours post-dose|Analysis set included all participants who received study medication.||hours||Full Range|Median
667413|NCT01740362|Primary|Maximum Observed Plasma Concentration (Cmax)||0 (Pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10, 12, 16, 24, 48 hours post-dose|Analysis set included all participants who received study medication.||ng/mL||Standard Deviation|Mean
667414|NCT01740362|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|0 (Pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10, 12, 16, 24, 48 hours post-dose|Analysis set included all participants who received study medication.||nanogram*hour/milliliter (ng*hr/mL)||Standard Deviation|Mean
667434|NCT01740089|Other Pre-specified|Immunogenicity|Number of randomized patients with neutralizing antibodies to IFN alfa on weeks 0, 12, 24, 48 (for patients with genotype 1 or 4) and 24 weeks after last dose of study treatment.|Weeks 0, 12, 24, 48 (for patients with genotype 1 or 4) and 24 weeks after last dose of study treatment|||participants|||Number
667435|NCT01740089|Secondary|Number of Patients Who Have Undetectable HCV RNA (< 15 IU/ml) at the End of Treatment.||After 24 weeks of treatment for patients with genotype 2 or 3 and after 48 weeks of treatment for patients with genotype 1 or 4.|||participants|||Number
667428|NCT01740206|Secondary|mYPAS Measurement in Patients Not Receiving Midazolam|"modified Yale Preoperative Anxiety Scale (mYPAS), which is commonly used for assessing anxiety during the induction of anesthesia, administered to patients who did not receive midazolam prior to anesthesia induction.
Assessment items: Activity (A) 1-4 points (A = score/4), Vocalizations (V) 1-6 points (V = score/6), Emotional expressivity (E) 1-4 points (E = score/4), State of arousal (S) 1-4 points (S = score/4), Use of parent (U) 1-4 points (U = score/4). Final score = [(A + V + E + S +U)/5] x 100. Higher score = more anxiety."|Day 1|Of the 48 subjects analyzed, 38 subjects did not receive midazolam prior to their surgical procedure.||scores on a scale||Inter-Quartile Range|Median
667429|NCT01740206|Secondary|mYPAS Measurement in Patients Receiving Midazolam|"modified Yale Preoperative Anxiety Scale (mYPAS), which is commonly used for assessing anxiety during the induction of anesthesia, administered to patients who received midazolam prior to anesthesia induction.
Assessment items: Activity (A) 1-4 points (A = score/4), Vocalizations (V) 1-6 points (V = score/6), Emotional expressivity (E) 1-4 points (E = score/4), State of arousal (S) 1-4 points (S = score/4), Use of parent (U) 1-4 points (U = score/4). Final score = [(A + V + E + S +U)/5] x 100. Higher score = more anxiety."|Day 1|Of the 48 subjects analyzed, 10 subjects received midazolam prior to their surgical procedure.||scores on a scale||Inter-Quartile Range|Median
667430|NCT01740206|Secondary|Mean Blood Pressure|Mean blood pressure prior to anesthetic induction|Day 1|||mmHg||Standard Deviation|Mean
667431|NCT01740206|Secondary|Diastolic Blood Pressure|Diastolic blood pressure prior to anesthetic induction|Day 1|||mmHg||Standard Deviation|Mean
667432|NCT01740206|Secondary|Systolic Blood Pressure|Systolic blood pressure prior to anesthetic induction|Day 1|||mmHg||Standard Deviation|Mean
667433|NCT01740206|Primary|Heart Rate|Heart rate prior to anesthetic induction|Day 1|||BPM||Standard Deviation|Mean
669655|NCT01709708|Secondary|Acute Medications Usage|Number of acute medications used during Treatment period (estimated 6 weeks) and Follow-Up (estimated 4 weeks) (Group A vs. Group B).|Estimated 10 Weeks||||||
667439|NCT01739803|Secondary|Days in Hospital|"We used a standardized patient reporting approach to collect direct healthcare utilizations data, including days in hospital. A brief healthcare screening questionnaire was administered to both the intervention and control groups on a monthly basis during the one-year study period. Monthly recall periods were chosen to minimize bias and forgetfulness. The questionnaire collected the number of times each month a participant utilized a direct medical service, specifically, days in hospital, emergency department (ED) visit, outpatient visit (clinic, physician office), and home healthcare visit.
Analysis compared proportion of each group who had at least one day in hospital during the 12-month study period."|12 months|||percentage of participants|||Number
667440|NCT01739803|Secondary|Health-related Quality of Life (HQoL)|The EQ-5D is a multi-attribute, preference-based HQoL instrument. Considered a global HQoL measure, the EQ-5D is a descriptive system that classifies respondents into one of 243 distinct health states based on five dimensions (i.e., mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension has three levels, reflecting “no problems,” “some problems,” and “extreme problems.” A scoring function assigns a value (EQ-5DIndex score) to self-reported health states from a set of preference weights that have been empirically derived. The EQ-5D's total scale (preference value) range is from 0 to 1.0. On this scale, the preference value of 1.0 represents perfect health and 0.0 represents death. Preference values less than 0 are possible, but not reflected on the scale, and reflect health states that the U.S. population consider worse than death.|12 months|||units on a scale||Standard Deviation|Mean
667441|NCT01739803|Primary|Comparison of Average Immunosuppressant Therapy Adherence for 12-month Study Period|"Immunosuppressant therapy adherence as measured by pharmacy refill records. Adherence was calculated quarterly for one year by using the number of days between prescription (IST) refills. If the total number of days between refills was less than or equal to the total days’ supply of IST, the participant’s adherence rate was 1.0, or 100%. If the number of days between refills was greater than the days’ supply, the adherence rate was calculated as follows:
1 – [(Days Between Refills – Total Days Supply)/Days Between Refills] = Adherence Rate for Quarterly Time Period
At the end of the 12-month study period, the quarterly adherence rates were averaged to produce an overall adherence rate for the study period."|12 months|Intention to treat, as per protocol||medication possession ratio (proportion)||Standard Deviation|Mean
667442|NCT01739790|Primary|Changes in the Saint George's Respiratory Questionnaire|The St. George's Respiratory Questionnaire (SGRQ) is scored on a scale of 1 to 100 with 100 representing the worst respiratory health status. The instrument is self-administered at baseline and again after 8-weeks of treatment.|Baseline to 8 weeks|||units on a scale||Standard Deviation|Mean
667443|NCT01739595|Primary|Change in Sperm Concentration|"Proportion of subjects with a 50% or greater decrease in sperm concentration from baseline after 12 weeks of treatment in Androxal treated subjects to placebo.
The difference between the proportions (placebo minus Androxal) and corresponding 95% confidence interval was determined and compared to the equivalence limit of -20%. If the lower limit of the 95% confidence interval was greater than -20%, then Androxal would be concluded to be non-inferior to placebo in causing a 50% reduction in sperm concentrations."|3 months|ITT||percentage of subjects|||Number
667444|NCT01739595|Primary|Subjects With Testosterone in Normal Range After Treatment|"Proportion (percent) of subjects with average serum concentration (Cavg) for T in the normal range (300 – 1040 ng/dL) after 12 weeks of treatment. Cavg was calculated as the numerical average of 24-hour serial testosterone assessments at 0, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours after dosing.
If the lower limit of the 95% confidence interval for the Androxal treatment group at Week 12 is at least 67%, then the coprimary endpoint based on the Cavg for testosterone would have been achieved.
FDA specified primary endpoint did not include comparison to placebo, thus the proportion of placebo subjects with average serum concentration (Cavg) for T in the normal range (300 - 1040 ng/dL) after 12 weeks of treatment was not calculated."|3 months|ITT population.||Percentage of Subjects||95% Confidence Interval|Number
667445|NCT01739361|Secondary|Serum Creatinine After 72 Hours of Treatment With Acetaminophen or Placebo, Adjusted for Baseline Creatinine||72 hours||||||
667446|NCT01739361|Secondary|In-hospital Mortality||Patients will be followed through the end of their hospital stay, an average of 5 weeks||||||
667447|NCT01739361|Primary|F2-isoprostanes After 72 Hours of Acetaminophen or Placebo|F2-isoprostanes are a marker of oxidative stress, specifically lipid peroxidation.|72 hours after randomization|||pg/mL||Inter-Quartile Range|Median
667448|NCT01738984|Other Pre-specified|Return to Drinking Between Baseline and 12 Weeks|drinking status measured via online survey taken at baseline and 12 week|12 weeks|number of participants who never/rarely drank at baseline but reported drank 1 or more drink per week at 12 weeks.||participants|||Number
667449|NCT01738984|Secondary|Number Who Returned to Smoking From Baseline and 12 Weeks|change in smoking status between baseline and 12 week assessment will be collected via survey at baseline and at the 12 week survey|12 weeks|Number of participants who were not smoking at baseline but reported returned to smoking on 12 week survey.||participants|||Number
667450|NCT01738984|Primary|Minutes Per Week of Moderate-to-Vigorous Physical Activity (MPVA Min/wk) Assessed at 12 Weeks|physical activity will be obtained via online surveys at the 12 week assessment point|12 weeks|||MVPA minutes per week||95% Confidence Interval|Mean
667451|NCT01738971|Other Pre-specified|Qualitative Outcomes : Pharmacist's Views on Interventions and Any Study Difficulties||12 months||||||
667452|NCT01738971|Other Pre-specified|Qualitative Outcomes : Women's Views on Different Measures to Determine Validity of Self-reported Data on Contraceptive Use , Determined by in Depth Interviews.||8 months||||||
667453|NCT01738971|Secondary|Proportion of Women Who Agree to Participate Who Can be Successfully Contacted||8 months|||participants|||Number
667454|NCT01738971|Secondary|Completeness (Quality) of Data Recorded by Pharmacists (Numbers of Women Attending for EC,Demographics of All Attendees- Age, Ethnicity Etc)||8 months||||||
667455|NCT01738971|Secondary|Pharmacy Recruitment Rates|Proportion of participants that pharmacists were successful in recruiting during the specified 8 month recruitment time period. Initial target set to recruit 60 participants to each arm/group.|8 months|||participants|||Number
667485|NCT01738646|Secondary|Median Overall Survival (OS)|Overall survival is defined as the time in months from the start of protocol treatment until the date of death, or the date of last follow-up if alive. Kaplan-Meier methods will be used to estimate overall survival.|3 Years|Intent-to-treat||months||95% Confidence Interval|Median
667456|NCT01738971|Primary|Self-reported Uptake of Effective Ongoing Contraception (Not Condoms)|Outcome measure identified when participants conducted for agreed telephone interview 6-8 weeks following recruitment to study. Participants asked via telephone what method of contraception, if any, there were currently using.|6-8 weeks after EC|A small number of participants were identified who had been recruited to the study although were already using an effective method of contraception (i.e. using a contraceptive pill but had forgot to take), and continued to use the same method at follow-up. These participants were excluded from analysis.||participants|||Number
667457|NCT01738919|Secondary|Flexion of the Distal Interphalangeal Joint.|Flexion of the distal interphalangeal joint. Measured with goniometer.|6 months|||degrees||95% Confidence Interval|Mean
667458|NCT01738919|Secondary|DASH|Questionary: Disabilities of the Arm, Shoulder and Hand Danish version (qDASH). Scale range 0–100, with 0 indicating no disability.|6 month|||units on a scale||Inter-Quartile Range|Median
667459|NCT01738919|Secondary|Complications|Number of participants with nail deformities.|6 month|||participants|||Number
667460|NCT01738919|Secondary|Bump|Number of participants with the presence of a bump on the fracture-site.|6 month|||participants|||Number
667461|NCT01738919|Secondary|Pain|Pain in the affected join. Pain intensity were reported on a numeric rating scale (NRS), from 0–10, with 0 indicating no pain.|6 month|||units on a scale||Inter-Quartile Range|Median
667462|NCT01738919|Primary|Extension Deficit in the Affected Distal Interphalangeal Joint.|Extension deficit measured in degrees, using goniometer. (The lacking extension from at straight stretched finger = degrees of extension deficit)|6 month|||degrees extension deficit||95% Confidence Interval|Mean
667463|NCT01738750|Secondary|Hospital/Operative Dollars|A comparison of the overall hospital admission and operative dollars for acute appendicitis and appendectomy between the two groups|Data will be collected within an expected average of 3 months post-discharge with data presented within 1 year|||Dollar||Inter-Quartile Range|Median
667464|NCT01738750|Primary|Choice Based on Cost|The group given information related to the cost of each surgical procedure will more often choose the less expensive procedure as compared to those not given cost information|Outcome assessed prior to surgical procedure with data presented within 1 year|||percentage of open appendectomy|||Number
667465|NCT01738737|Secondary|Change From Baseline in Timed Get Up and Go Test|Higher values represent worse outcomes The assessment will be done in the patient's first evaluation and after each intervention.|Baseline and post-intervention, up to 11 weeks|||seconds||Inter-Quartile Range|Median
667466|NCT01738737|Secondary|Change From Baseline in Lequesne Functional Questionnaire|The scale varies from 0 to 24. Higher values represent worse outcomes The assessment will be done in the patient's first evaluation and after each intervention.|Baseline and post-intervention, up to 11 weeks|||units on a scale||Inter-Quartile Range|Median
667467|NCT01738737|Secondary|Change From Baseline in Range of Motion of Flexion of the Knee|Higher values represent better outcomes The assessment will be done in the patient's first evaluation and after each intervention.|Baseline and post-intervention, up to 11 weeks|||degress||Inter-Quartile Range|Median
667468|NCT01738737|Secondary|Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index|The scale varies from 0 to 96. Higher values represent worse outcomes. The assessment will be done in the patient's first evaluation and after each intervention.|Baseline and post-intervention, up to 11 weeks|||units on a scale||Inter-Quartile Range|Median
667469|NCT01738737|Primary|Change From Baseline in Visual Analogue Scale for Pain|The scale varies from 0 to 10. Higher values represent worse outcomes. The assessment will be done in the patient's first evaluation and after each intervention.|Baseline and post-intervention, up to 11 weeks|||units on a scale||Standard Deviation|Mean
667470|NCT01738698|Secondary|Ambulatory Blood Pressure Monitoring (ABPM)||Baseline and Weeks 4 and 10|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
667471|NCT01738698|Secondary|Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at 12 Weeks||Baseline and 12 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
667472|NCT01738698|Secondary|Columbia-Suicide Severity Rating Scale (C-SSRS)||Up to 12 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
667473|NCT01738698|Secondary|Clinical Global Impression-Schizophrenia Degree of Change (CGI-SCH-C) Scale||Up to 12 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
667474|NCT01738698|Secondary|Clinical Global Impression-Schizophrenia Severity of Illness (CGI-SCH-S) Scale||Baseline and week 12|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
667475|NCT01738698|Secondary|Change From Baseline in Clinical Evaluation of Harmful Behavior (CEHB) Scale at 12 Weeks||Baseline and 12 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
667476|NCT01738698|Secondary|Change From Baseline in Social Functioning Scale (SFS) at 12 Weeks||Baseline and 12 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
667477|NCT01738698|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at 12 Weeks||Baseline and 12 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
667478|NCT01738698|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at 12 Weeks||Baseline and 12 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
667479|NCT01738698|Secondary|Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) at 12 Weeks||Baseline and 12 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
667480|NCT01738698|Secondary|Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at 12 Weeks||Baseline and 12 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
667481|NCT01738698|Secondary|Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at 12 Weeks||Baseline and 12 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
667486|NCT01738646|Secondary|Median Progression-free Survival (PFS)|Progression-free survival is defined as the time in months from the start of protocol treatment until the date of progression or death if death occurred before progression. If the participant is alive and progression-free, PFS will be censored at the date of last follow-up. Kaplan-Meier methods will be used to estimate progression-free survival.|3 Years|Intent-to-treat||months||95% Confidence Interval|Median
667487|NCT01738646|Secondary|Percentage of Participants Who Experience Grade 3 or Greater, Treatment Related, Non-hematologic Toxicities.|The percentage of participants who experience grade 3 or greater, treatment-related, non-hematologic toxicities will be calculated.|2.7 Years|Intent-to-treat||percentage of participants|||Number
667488|NCT01738646|Secondary|Radiographic Response|The percentage of participants with a complete or partial response as determined by modified Response Assessment in Neuro-Oncology (RANO) criteria will be determined. Complete Response (CR) is defined as complete disappearance on MR/CT of all enhancing tumor and mass effect, off all corticosteroids (or receiving only adrenal replacement doses) and accompanied by a stable or improving neurologic examination. Partial Response (PR) is defined as greater than or equal to 50% reduction in tumor size on MR/CT by bi-dimensional measurement, on a stable or decreasing dose of corticosteroids and accompanied by a stable or improving neurologic examination. Tumor assessments are done at baseline and the end of every second cycle (every 8 weeks) thereafter.|3 Years|Intent-to-treat||percentage of participants||95% Confidence Interval|Number
667489|NCT01738646|Primary|Six-month Progression-free Survival (PFS6)|The percentage of participants alive and progression-free at 6 months after the start of study treatment will be determined. Based on Response Assessment in Neuro-Oncology (RANO) criteria, progression is defined as a ≥ 25% increase in sum of the products of perpendicular diameters of enhancing lesions; significant increase in T2/FLAIR; any new lesion; clear clinical deterioration not attributable to other causes apart from the tumor; failure to return for evaluation as a result of death or deteriorating condition; or clear progression of non-measurable disease. PFS6 will be calculated from the date study treatment started until the date of progression or death, or the date of last follow-up if participants are alive without progression. Kaplan-Meier methods will be used to estimate survival.|6 months|Intent-to-treat||percentage of participants||95% Confidence Interval|Number
667490|NCT01738581|Secondary|Change From Baseline in Physical Function at Posttest (Day 5)|Participants completed the full SF-36 assessment with subsection of interest: “physical functioning”.|Baseline and Posttest|All participants who completed the first phase were included in the analysis. Data were only analyzed in the first intervention period of the study because there was a lack of a washout effect between periods. This lack of washout made data from the second intervention period unreliable.||Participants|||Count of Participants
667491|NCT01738581|Secondary|Change From Baseline for Physician Rated Impairment at Posttest (Day 5)|Video recordings were made as participants wrote on a pad of paper with pen. Participants were asked to draw a series of 10 loops across the pad of paper followed by “The dog is barking” and their signature, each repeated four times. A physician blinded to participant allocation rated recordings. Scoring criteria were adapted from a standardized writer's cramp rating scale (WCRS) (Wissel et al., 1996), rating pathological flexion or extension at the wrist, fingers and elbow, presence of tremor, dystonic posture, writing speed and latency of dystonic symptoms. Final scores are expressed as a rating listed as a movement score.|Baseline and Posttest|All participants who completed the first phase were included in the analysis. Data were only analyzed in the first intervention period of the study because there was a lack of a washout effect between periods. This lack of washout made data from the second intervention period unreliable.||Participants|||Count of Participants
667492|NCT01738581|Secondary|Change From Baseline for Pressure During Hand Writing at Posttest (Day 5)|Digitized handwriting was assessed using a computerized tablet (WACOM Co., Ltd., japan) with MovAlyzeR® (Neuroscript LLC, Tempe, AZ) hardware and software. Participants used a custom modified digitized pen (Kiko Software, Netherlands) to write in a self-selected pace and style on the tablet with real-time visual feedback. Writing tasks included “My country tis of thee” at a self-selected pace, repeated eight times. Data were sampled at 215 Hz (resolution: 5080 lpi, accuracy: ±0.01 pressure range: 0–800 g). Writing samples were segmented by points of minimal velocity into single strokes for analysis. Pressure for each stroke was automatically calculated within the software.|Baseline and Posttest|One participant that did not display symptoms affecting handwriting and did not participate in the handwriting analysis. Data were only analyzed in the first intervention period of the study because there was a lack of a washout effect between periods. This lack of washout made data from the second intervention period unreliable.||Participants|||Count of Participants
667493|NCT01738581|Secondary|Change From Baseline in Cortical Silent Period at Posttest (Day 5)|"Cortical silent period (CSP) testing was completed during an isometric contraction of the target muscle whereby the motor evoked potential is followed by a short duration of electromyographic quiescence. The maximal voluntary contraction for finger abduction was recorded using a custom strain gauge placed around the index finger. Real-time visual feedback was given on a laptop screen to project the force produced by the participant and 20% of the maximum of three trials was calculated and displayed on a target line. For the CSP, participants were asked to contract until the target line was met, then a single transcranial magnetic stimulation pulse was delivered to the motor cortex. Ten trials were collected with a short rest period to prevent fatigue.
CSP duration was calculated in milliseconds (ms). CSP EMG data were first rectified, and then a 10-ms moving average calculation was applied to the data. The onset of the CSP was set as the time point of the delivery of the TM"|Baseline and Posttest|All participants who completed the first phase were included in the analysis. Data were only analyzed in the first intervention period of the study because there was a lack of a washout effect between periods. This lack of washout made data from the second intervention period unreliable.||Participants|||Count of Participants
667494|NCT01738581|Secondary|Change From Baseline in Sensation at Posttest (Day 5)|Examinations included two point discrimination. Two-point discrimination threshold was completed using a Disk-Criminator™. Participants were asked to reply “one” or “two” after each presentation. Static and dynamic stimuli were presented to the index and ring fingers bilaterally, meaning it was presented as a static stimuli or it was slowly swept across the skin (dynamic).|Baseline and Posttest|All participants who completed the first phase were included in the analysis. Data were only analyzed in the first intervention period of the study because there was a lack of a washout effect between periods. This lack of washout made data from the second intervention period unreliable.||Participants|||Count of Participants
667495|NCT01738581|Secondary|Change From Baseline in Arm Dystonia Disability Scale at Posttest (Day 5)|The Arm Dystonia Disability Scale (ADDS) is a survey where participants rate task difficulty for activities such as writing, handling utensils, and buttoning on a scale of 1–4 (1 = no difficulty ,4 = not able or marked difficulty). This is a subjective assessment of impairment due to focal hand dystonia. Scores are determined using an equation: total points scored, divided by the maximum possible (23), multiplied by the quotient by 90 and subtract from 90%. Scores range from 0%-90% with higher scores indicating more function.|Baseline and Posttest|All participants who completed the first phase were included in the analysis. Data were only analyzed in the first intervention period of the study because there was a lack of a washout effect between periods. This lack of washout made data from the second intervention period unreliable.||percentage of function||Standard Deviation|Mean
667496|NCT01738581|Primary|Change From Baseline in Global Rating of Change at Posttest (Day 5)|Symptom severity was assessed using the global rating of change (GROC). For the GROC, participants were asked to identify between one to three functions most impacted by focal hand dystonia. At posttest 1 they were then asked to select a rating of perceived change that represented the level of function compared to baseline. Perceived change consisted of a ±7 point Likert scale (+7= a very great deal better, 0= no change, -7= a very great deal worse).|Baseline and Posttest|All participants who completed the first phase were included in the analysis. Data were only analyzed in the first intervention period of the study because there was a lack of a washout effect between periods. This lack of washout made data from the second intervention period unreliable.||units on a scale||Full Range|Mean
667497|NCT01738438|Post-Hoc|15-Week Clinical Benefit Rate|The 15-week clinical benefit rate (CBR) was defined as absence of disease progression (PD) per RECIST1.1 criteria at the second disease assessment (week 15). Radiographic PD is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum since beginning therapy, the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Confirmatory scans for response were required 3 weeks following initial documentation.|Disease was evaluated radiologically at baseline, week 6 and week 15 on treatment.|The analysis dataset is comprised of all treated patients.||proportion of participants||95% Confidence Interval|Number
667498|NCT01738438|Secondary|Progression Free Survival|Progression-free survival (PFS) estimated using Kaplan-Meier methods was defined as the time from registration to documented disease progression (PD) or death. Based on RECIST1.1, radiographic PD is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum since beginning therapy, the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Patients who were event-free were censored at the date of their last disease evaluation.|Disease was evaluated radiologically at baseline, week 6 and every 9 weeks on treatment; Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 3 cycles range (1-17).|The analysis dataset is comprised of all treated patients.||months||95% Confidence Interval|Median
667499|NCT01738438|Primary|Objective Response Rate|The objective response rate (ORR) was defined as achieving complete response (CR) or partial response (PR) on treatment based on RECIST1.1 criteria. For target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. Confirmatory scans were required 3 weeks following initial documentation.|Disease was evaluated radiologically at baseline, week 6 and every 9 weeks on treatment; Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 3 cycles range (1-17).|The analysis dataset is comprised of all treated patients.||proportion of participants||95% Confidence Interval|Number
667500|NCT01738321|Primary|Change in Intracuff Pressure||1 day|||cmH2O||Standard Deviation|Mean
667501|NCT01737996|Primary|Cmax and Cmax,ss of Faldaprevir (Combined Treatment Part)|Maximum measured concentration of Faldaprevir on Day 1 and at steady state on Day 16.|After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12, 24 h after drug administration in the morning.|PKS including patients with available data.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
667502|NCT01737996|Primary|AUC(0-24h) and AUC(0-24h,ss) of Faldaprevir (Combined Treatment Part)|Area under the concentration-time curve of Faldaprevir over the uniform dosing interval 0 to 24 h on Day 1 and at steady state on Day 16.|After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
667503|NCT01737996|Primary|C(12h) and C(12h,ss) of CD 6168 Acylglucuronide (Combined Treatment Part)|"Concentration of CD 6168 acylglucuronide at the end of the dosing interval 0 to 12 h on Day 1 and at steady state on Day 16.
CD 6168 acylglucuronide is a metabolite of Deleobuvir."|After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
667504|NCT01737996|Primary|Cmax and Cmax,ss of CD 6168 Acylglucuronide (Combined Treatment Part)|"Maximum measured concentration of CD 6168 acylglucuronide on Day 1 and at steady state on Day 16.
CD 6168 acylglucuronide is a metabolite of Deleobuvir."|After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
667505|NCT01737996|Primary|AUC(0-12h) and AUC(0-12h,ss) of CD 6168 Acylglucuronide (Combined Treatment Part)|"Area under the concentration-time curve of CD 6168 acylglucuronide over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 16.
CD 6168 acylglucuronide is a metabolite of Deleobuvir."|After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
667506|NCT01737996|Primary|C(12h) and C(12h,ss) of BI 208333 (Combined Treatment Part)|"Concentration of BI 208333 at the end of the dosing interval 0 to 12 h on Day 1 and at steady state on Day 16.
BI 208333 is a major metabolite of Deleobuvir."|After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
667507|NCT01737996|Primary|Cmax and Cmax,ss of BI 208333 (Combined Treatment Part)|"Maximum measured concentration of BI 208333 on Day 1 and at steady state on Day 16.
BI 208333 is a major metabolite of Deleobuvir."|After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
667508|NCT01737996|Primary|AUC(0-12h) and AUC(0-12h,ss) of BI 208333 (Combined Treatment Part)|"Area under the concentration-time curve of BI 208333 over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 16.
BI 208333 is a major metabolite of Deleobuvir."|After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
667509|NCT01737996|Primary|C(12h) and C(12h,ss) of CD 6168 (Combined Treatment Part)|"Concentration of CD 6168 at the end of the dosing interval 0 to 12 h on Day 1 and at steady state on Day 16.
CD 6168 is a major metabolite of Deleobuvir."|After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
667510|NCT01737996|Primary|Cmax and Cmax,ss of CD 6168 (Combined Treatment Part)|"Maximum measured concentration of CD 6168 on Day 1 and at steady state on Day 16.
CD 6168 is a major metabolite of Deleobuvir."|After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
667511|NCT01737996|Secondary|Cmax and Cmax,ss of CD 6168 Acylglucuronide (Multiple Rising Dose Part)|"Maximum measured concentration of CD 6168 acylglucuronide on Day 1 and at steady state on Day 9.
CD 6168 acylglucuronide is a metabolite of Deleobuvir."|After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
667512|NCT01737996|Secondary|AUC(0-12h) and AUC(0-12h,ss) of CD 6168 Acylglucuronide (Multiple Rising Dose Part)|"Area under the concentration-time curve of CD 6168 acylglucuronide over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 9.
CD 6168 acylglucuronide is a metabolite of Deleobuvir."|After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
667513|NCT01737996|Secondary|Cmax and Cmax,ss of BI 208333 (Multiple Rising Dose Part)|"Maximum measured concentration of BI 208333 on Day 1 and at steady state on Day 9.
BI 208333 is a major metabolite of Deleobuvir."|After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
667514|NCT01737996|Secondary|AUC(0-12h) and AUC(0-12h,ss) of BI 208333 (Multiple Rising Dose Part)|"Area under the concentration-time curve of BI 208333 over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 9.
BI 208333 is a major metabolite of Deleobuvir."|After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
667515|NCT01737996|Secondary|Cmax and Cmax,ss of CD 6168 (Multiple Rising Dose Part)|"Maximum measured concentration of CD 6168 on Day 1 and at steady state on Day 9.
CD 6168 is a major metabolite of Deleobuvir."|After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
667516|NCT01737996|Secondary|AUC(0-12h) and AUC(0-12h,ss) of CD 6168 (Multiple Rising Dose Part)|"Area under the concentration-time curve of CD 6168 over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 9.
CD 6168 is a major metabolite of Deleobuvir."|After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
667517|NCT01737996|Secondary|Cmax and Cmax,ss of Deleobuvir (Multiple Rising Dose Part)|Maximum measured concentration of Deleobuvir on Day 1 and at steady state on Day 9.|After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
667518|NCT01737996|Primary|AUC(0-12h) and AUC(0-12h,ss) of CD 6168 (Combined Treatment Part)|"Area under the concentration-time curve of CD 6168 over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 16.
CD 6168 is a major metabolite of Deleobuvir."|After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
667536|NCT01737840|Primary|Visual Analogue Scale Score|The investigators are measuring the change of pain from the baseline to the 30th and 60th minutes by visual anologue scale (VAS). Visual Analogue Scale measurement is between 0 (no pain) and 100 (worst pain). A decrease of 13 or 16 mm in VAS score is accepted as a minimum clinically significant change in pain.|30th and 60th minutes|||Visual Analogue Scale||Standard Deviation|Mean
667519|NCT01737996|Primary|C(12h) and C(12h,ss) of Deleobuvir (Combined Treatment Part)|Concentration of Deleobuvir at the end of the dosing interval 0 to 12 h on Day 1 and at steady state on Day 16.|After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
667520|NCT01737996|Primary|Cmax and Cmax,ss of Deleobuvir (Combined Treatment Part)|Maximum measured concentration of Deleobuvir on Day 1 and at steady state on Day 16.|After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
667521|NCT01737996|Primary|AUC(0-12h) and AUC(0-12h,ss) of Deleobuvir (Combined Treatment Part)|Area under the concentration-time curve (AUC) of Deleobuvir over the uniform dosing interval 0 to 12 h (hours) on Day 1 and at steady state on Day 16.|After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 hours (h) after drug administration in the morning.|PKS. The pharmacokinetic set (PKS) included all subjects of the treated set who provided at least 1 observation for at least 1 pharmacokinetic endpoint without important protocol violations relevant for the statistical evaluation of pharmacokinetic endpoints. Including patients with available data.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
667522|NCT01737996|Primary|Number of Healthy Subjects With AEs (Multiple Rising Dose Part)|Number of healthy subjects with any adverse event (AE) during the on-treatment period.|From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration)|Treated Set. The treated set included all subjects who were documented to have taken at least 1 dose of study medication.||participants|||Number
667523|NCT01737996|Secondary|AUC(0-12h) and AUC(0-12h,ss) of Deleobuvir (Multiple Rising Dose Part)|Area under the concentration-time curve of Deleobuvir over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 9.|After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
667524|NCT01737944|Primary|Bioequivalence Based Upon Dose-Normalized Cmax for MTX|Dose-normalized maximum observed concentration for each treatment|24 Hour period|The Population was defined as all randomized subjects who received at least 1 dose of study drug and who had at least 1 valid post-dose plasma concentration value.||ng/mL/mg||Standard Deviation|Mean
667525|NCT01737944|Primary|Bioequivalence Based Upon Dose-Normalized AUC[0-24] for MTX|Dose-normalized area under the curve from time zero to 24 hours post-dose (AUC[0-24]/Dose) for each treatment|24 Hour period|Dose-normalized MTX PK parameter AUC(0-24)/Dose used for comparison||ng*hr/mL/mg||Standard Deviation|Mean
667526|NCT01737944|Primary|Bioequivalence Based Upon Dose-Normalized AUC[0-Inf] for MTX|Dose-normalized area under the curve from time zero to infinity (AUC[0-inf]/Dose) for each treatment|24 Hour period|The Population was defined as all randomized subjects who received at least 1 dose of study drug and who had at least 1 valid post-dose plasma concentration value.||ng*hr/mL/mg||Standard Deviation|Mean
667527|NCT01737931|Secondary|Itching of Application Site Evaluated by VAS After Patch Removal|"Changes of itching of application site evaluated by VAS after patch removal (acceleration and dose-escalation periods).
The score ranges from 0 (no itching) to 100 (strongest imaginable itching)."|Up to 96 hours after patch removal|FAS||Scores on a scale||Standard Deviation|Mean
667528|NCT01737931|Secondary|Skin Irritation Score After Patch Removal|Numbers of subjects with each skin irritation score. The scale scoring criteria are 0(-): Negative, 0.5(±): Faint erythema, 1(+): Erythema, 2(++): Erythema + edema, 3(+++): Erythema + edema + papules, serous papule, vesicles, 4(++++): Coalescing vesicles.|Up to 72 hours after patch removal|FAS subjects with a score of ≥ 0.5 (±) at Day 3||Percentage of participants|||Number
667529|NCT01737931|Primary|Itching of Application Site Evaluated by the Visual Analogue Scale (VAS)|"Itching of application site evaluated by the visual analogue scale (VAS) 24 hours after 2 mg/24 hour patch removal (dose-escalation period) and difference between Steroid or Antihistamine and No-treatment.
The score ranges from 0 (no itching) to 100 (strongest imaginable itching)."|24 hours after 2 mg/24 hr patch removal|FAS||Scores on a scale||95% Confidence Interval|Mean
667530|NCT01737931|Primary|Skin Irritation Score of the Application Site|"Skin irritation score of the application site 24 hours after 2 mg/24 hour patch removal (dose-escalation period) and difference between Steroid or Antihistamine and No-treatment.
The scale scoring criteria are 0(-): Negative, 0.5(±): Faint erythema, 1(+): Erythema, 2(++): Erythema + edema, 3(+++): Erythema + edema + papules, serous papule, vesicles, 4(++++): Coalescing vesicles."|24 hours after 2 mg/24 hr patch removal|Full analysis set (FAS) subjects with a score of ≥ 0.5 (±) at Day 3||Scores on a scale||95% Confidence Interval|Mean
667531|NCT01737879|Secondary|Peginesatide Dose by Visit||Baseline and Weeks 5, 9, 13, and 17|Primary analysis set, with available data at each time point (indicated by n)||mg||Standard Deviation|Mean
667532|NCT01737879|Secondary|Hemoglobin Concentration by Visit||Baseline and Weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, and 21|"Primary analysis set includes all enrolled participants who received at least 1 dose of investigational product. The number of participants with available data at each time point is indicated by n."||g/dL||Standard Deviation|Mean
667533|NCT01737879|Secondary|Mean Dose of Epoetin Alfa During the Evaluation Period|No participant reached the evaluation period, therefore, this endpoint could not be evaluated.|Last 8 weeks of epoetin alfa treatment period period (Weeks 49 to 56).||||||
667534|NCT01737879|Primary|Mean Hemoglobin Concentration During the Evaluation Period|"The hemoglobin concentrations during the evaluation period after the conversion to epoetin alfa were to be averaged for each participant and then summarized over all participants.
No participant reached the evaluation period, therefore, the primary efficacy endpoint could not be evaluated."|Last 8 weeks of epoetin alfa treatment period period (Weeks 49 to 56).||||||
667535|NCT01737840|Secondary|Need for Additional Drug|The investigators are measuring the need for additional drug at the end of 60 minutes.|60 th minute|||participants|||Number
667955|NCT01732835|Secondary|Peak Gradient - Change From Baseline|Transthoracic echocardiography parameter|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.||mm Hg||Standard Deviation|Mean
667537|NCT01737762|Secondary|Time in Days to Closure|Compare the efficacy of HP802-247 plus compression therapy against Vehicle plus compression therapy in achieving complete wound closure, based on time in days to closure over the 16-week treatment period from baseline.|16 Weeks|||Days||Standard Deviation|Mean
667538|NCT01737762|Primary|Wound Closure|Compare HP802-247 plus compression therapy against Vehicle plus compression therapy for proportion of subjects with complete wound closure over the 16-week treatment period from baseline.|16 Weeks|||participants|||Number
667539|NCT01737710|Secondary|Seroconversion, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular – Influenza H3N2|The difference in the percentage of moderate to severe AD participants that achieved seroconversion at Day 28 between those given a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone Intradermal vaccine and those given a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone (Intramuscular) vaccine. Seroconversion is defined as a 4-fold or greater increase in serum hemagglutination-inhibition [HAI] antibody titers against influenza H3N2 compared to baseline values, which represents the minimum intended effect of vaccination. Participants who achieved seroprotection, defined as having a sufficient antibody amount to avoid disease in half of the individuals infected with influenza H3N2, prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percentage of participants who achieved seroconversion at Day 28 who were not seroprotected prior to vaccination.|Day 28 Post Vaccination|Subset of the per protocol population that were not seroprotected against influenza H3N2 at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations.||percentage of participants|||Number
667540|NCT01737710|Secondary|Seroconversion, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular – Influenza H1N1|The difference in the percentage of moderate to severe AD participants that achieved seroconversion at Day 28 between those given a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone Intradermal vaccine and those given a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone (Intramuscular) vaccine. Seroconversion is defined as a 4-fold or greater increase in serum hemagglutination-inhibition [HAI] antibody titers against influenza H1N1 compared to baseline values, which represents the minimum intended effect of vaccination. Participants who achieved seroprotection, defined as having a sufficient antibody amount to avoid disease in half of the individuals infected with influenza H1N1, prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percentage of participants who achieved seroconversion at Day 28 who were not seroprotected prior to vaccination.|Day 28 Post Vaccination|Subset of the per protocol population that were not seroprotected against influenza H1N1 at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations.||percentage of participants|||Number
667541|NCT01737710|Secondary|Seroconversion, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular – Influenza B|The difference in the percentage of moderate to severe AD participants that achieved seroconversion at Day 28 between those given a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone Intradermal vaccine and those given a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone (Intramuscular) vaccine. Seroconversion is defined as a 4-fold or greater increase in serum hemagglutination-inhibition [HAI] antibody titers against influenza B compared to baseline values, which represents the minimum intended effect of vaccination. Participants who achieved seroprotection, defined as having a sufficient antibody amount to avoid disease in half of the individuals infected with influenza B, prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percentage of participants who achieved seroconversion at Day 28 who were not seroprotected prior to vaccination.|Day 28 Post Vaccination|Subset of the per protocol population that were not seroprotected against influenza B at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations.||percentage of participants|||Number
667542|NCT01737710|Secondary|Seroconversion, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal – Influenza H3N2|The difference in the percentage of participants that achieved seroconversion at Day 28 between non-AD and moderate to severe AD participants, following a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone Intradermal vaccine. Seroconversion is defined as a 4-fold or greater increase in serum hemagglutination-inhibition [HAI] antibody titers against influenza H3N2 compared to baseline values, which represents the minimum intended effect of vaccination. Participants who achieved seroprotection, defined as having a sufficient antibody amount to avoid disease in half of the individuals infected with influenza H3N2, prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percentage of participants who achieved seroconversion at Day 28 who were not seroprotected prior to vaccination.|Day 28 Post Vaccination|Subset of the per protocol population that were not seroprotected against influenza H3N2 at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations.||percentage of participants|||Number
667543|NCT01737710|Secondary|Seroconversion, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe AD, Intradermal – Influenza H1N1|The difference in the percentage of participants that achieved seroconversion at Day 28 between non-AD and moderate to severe AD participants, following a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone Intradermal vaccine. Seroconversion is defined as a 4-fold or greater increase in serum hemagglutination-inhibition [HAI] antibody titers against influenza H1N1 compared to baseline values, which represents the minimum intended effect of vaccination. Participants who achieved seroprotection, defined as having a sufficient antibody amount to avoid disease in half of the individuals infected with influenza H1N1, prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percentage of participants who achieved seroconversion at Day 28 who were not seroprotected prior to vaccination.|Day 28 Post Vaccination|Subset of the per protocol population that were not seroprotected against influenza H1N1 at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations.||percentage of participants|||Number
667685|NCT01736475|Secondary|Changes in Clinical Chemistry Laboratory Assessments From Screening - Creatinine, and Bilirubin||Screening, week 2, week 4, month 3, study completion/termination|Safety Analysis Set - Subset of participants with both screening visit data and follow on time point data.||µmol/L||Inter-Quartile Range|Median
667544|NCT01737710|Secondary|Seroconversion, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal – Influenza B|The difference in the percentage of participants that achieved seroconversion at Day 28 between non-AD and moderate to severe AD participants, following a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone Intradermal vaccine. Seroconversion is defined as a 4-fold or greater increase in serum hemagglutination-inhibition [HAI] antibody titers against influenza B compared to baseline values, which represents the minimum intended effect of vaccination. Participants who achieved seroprotection, defined as having a sufficient antibody amount to avoid disease in half of the individuals infected with influenza B, prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percentage of participants who achieved seroconversion at Day 28 who were not seroprotected prior to vaccination.|Day 28 Post Vaccination|Subset of the per protocol population that were not seroprotected against influenza B at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations.||percentage of participants|||Number
667545|NCT01737710|Secondary|Seroprotection, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular – Influenza H3N2|The difference in the percentage of moderate to severe AD participants that achieved seroprotection against influenza H3N2 at Day 28 between those given a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone Intradermal vaccine and those given a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone (Intramuscular) vaccine. Seroprotection is defined as having a serum hemagglutination-inhibition (HAI) antibody titer of 1:40 or greater, which represents a sufficient antibody amount to avoid disease in half of the individuals infected with influenza H3N2. Participants who achieved seroprotection prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percentage of participants who achieved seroprotection at Day 28 who were not seroprotected prior to vaccination.|Day 28 Post Vaccination|Subset of the per protocol population that were not seroprotected against influenza H3N2 at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations.||percentage of participants|||Number
667546|NCT01737710|Secondary|Seroprotection, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular – Influenza H1N1|The difference in the percentage of moderate to severe AD participants that achieved seroprotection against influenza H1N1 at Day 28 between those given a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone Intradermal vaccine and those given a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone (Intramuscular) vaccine. Seroprotection is defined as having a serum hemagglutination-inhibition (HAI) antibody titer of 1:40 or greater, which represents a sufficient antibody amount to avoid disease in half of the individuals infected with influenza H1N1. Participants who achieved seroprotection prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percentage of participants who achieved seroprotection at Day 28 who were not seroprotected prior to vaccination.|Day 28 Post Vaccination|Subset of the per protocol population that were not seroprotected against influenza H1N1 at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations.||percentage of participants|||Number
667547|NCT01737710|Secondary|Seroprotection, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular – Influenza B|The difference in the percentage of moderate to severe AD participants that achieved seroprotection against influenza B at Day 28 between those given a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone Intradermal vaccine and those given a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone (Intramuscular) vaccine. Seroprotection is defined as having a serum hemagglutination-inhibition (HAI) antibody titer of 1:40 or greater, which represents a sufficient antibody amount to avoid disease in half of the individuals infected with influenza B. Participants who achieved seroprotection prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percentage of participants who achieved seroprotection at Day 28 who were not seroprotected prior to vaccination.|Day 28 post vaccination|Subset of the per protocol population that were not seroprotected against influenza B at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations.||percentage of participants|||Number
667548|NCT01737710|Secondary|Fold-difference in Geometric Mean Serum Hemagglutination-inhibition (HAI) Antibody Titers, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal – Influenza H3N2|The fold-difference (defined as a ratio to describe the change from baseline to Day 28) in geometric mean serum HAI antibody titers against influenza H3N2 between non-AD and moderate to severe AD participants, following a single dose of the seasonal 2012-2013 Fluzone Intradermal vaccine. A fold-difference of greater than or equal to 1 indicated an increase in HAI antibody titers against influenza H3N2 as a result of vaccination; therefore, higher numbers indicate a greater probability of avoiding disease if infected with influenza H3N2 Participants who achieved seroprotection prior to vaccination were excluded from the analysis, which is defined as having a sufficient antibody amount to avoid disease in half of the individuals infected with influenza H3N2.|Day 28 post vaccination|Subset of the per protocol population that were not seroprotected against influenza H3N2 at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations.||HAI antibody titers||95% Confidence Interval|Geometric Mean
667556|NCT01737684|Secondary|Maximum Observed Plasma Drug Concentration (Cmax) After a Single Oral Dose of Vibegron 100 mg|Blood samples were collected for determination of vibegron levels predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours after dosing.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours postdose|PP population, which included participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of treatment, according to the underlying scientific model.||nM||95% Confidence Interval|Geometric Mean
667684|NCT01736475|Secondary|Changes in Hematology Laboratory Assessments From Screening – Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes||Screening, week 2, week 4, month 3, study completion/termination|Safety Analysis Set - Subset of participants with both screening visit data and follow on time point data.||giga (10^9) cells per liter (Gi/L)||Inter-Quartile Range|Median
667549|NCT01737710|Secondary|Fold-difference in Geometric Mean Serum Hemagglutination-inhibition (HAI) Antibody Titers, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal – Influenza H1N1|The fold-difference (defined as a ratio to describe the change from baseline to Day 28) in geometric mean serum HAI antibody titers against influenza H1N1 between non-AD and moderate to severe AD participants, following a single dose of the seasonal 2012-2013 Fluzone Intradermal vaccine. A fold-difference of greater than or equal to 1 indicated an increase in HAI antibody titers against influenza H1N1 as a result of vaccination; therefore, higher numbers indicate a greater probability of avoiding disease if infected with influenza H1N1. Participants who achieved seroprotection prior to vaccination were excluded from the analysis, which is defined as having a sufficient antibody amount to avoid disease in half of the individuals infected with influenza H1N1.|Day 28 post vaccination|Subset of the per protocol population that were not seroprotected against influenza H1N1 at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations||HAI antibody titers||95% Confidence Interval|Geometric Mean
667550|NCT01737710|Secondary|Fold-difference in Geometric Mean Serum Hemagglutination-inhibition (HAI) Antibody Titers, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal – Influenza B|The fold-difference (defined as a ratio to describe the change from baseline to Day 28) in geometric mean serum HAI antibody titers against influenza B between non-AD and moderate to severe AD participants, following a single dose of the seasonal 2012-2013 Fluzone Intradermal vaccine. A fold-difference of greater than 1 indicated an increase in HAI antibody titers against influenza B as a result of vaccination; therefore, higher numbers indicate a greater probability of avoiding disease if infected with influenza B. Participants who achieved seroprotection (which is defined as having a sufficient antibody amount to avoid disease in half of the individuals infected with influenza B) prior to vaccination were excluded from the analysis.|Day 28 post vaccination|Subset of the per protocol population that were not seroprotected against influenza B at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations.||HAI antibody titers||95% Confidence Interval|Geometric Mean
667551|NCT01737710|Primary|Seroprotection, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal – Influenza H3N2|The difference in the percentage of participants that achieved seroprotection against influenza H3N2 at Day 28 between non-AD and moderate to severe AD participants, following a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone Intradermal vaccine. Seroprotection is defined as having a serum hemagglutination-inhibition (HAI) antibody titer of 1:40 or greater, which represents a sufficient antibody amount to avoid disease in half of the individuals infected with influenza H3N2. Participants who achieved seroprotection prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percentage of participants who achieved seroprotection at Day 28 who were not seroprotected prior to vaccination.|Day 28 Post Vaccination|Subset of the per protocol population that were not seroprotected against influenza H3N2 at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations.||percentage of participants|||Number
667552|NCT01737710|Primary|Seroprotection, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal – Influenza H1N1|The difference in the percentage of participants that achieved seroprotection against influenza H1N1 at Day 28 between non-AD and moderate to severe AD participants, following a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone Intradermal vaccine. Seroprotection is defined as having a serum hemagglutination-inhibition (HAI) antibody titer of 1:40 or greater, which represents a sufficient antibody amount to avoid disease in half of the individuals infected with influenza H1N1. Participants who achieved seroprotection prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percentage of participants who achieved seroprotection at Day 28 who were not seroprotected prior to vaccination.|Day 28 Post Vaccination|Subset of the per protocol population that were not seroprotected against influenza H1N1 at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations.||percentage of participants|||Number
667553|NCT01737710|Primary|Seroprotection, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal – Influenza B|The difference in the percent of participants that achieved seroprotection against influenza B at Day 28 between non-AD and moderate to severe AD participants, following a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone Intradermal vaccine. Seroprotection is defined as having a serum hemagglutination-inhibition (HAI) antibody titer of 1:40 or greater, which represents a sufficient antibody amount to avoid disease in half of the individuals infected with influenza B. Participants who achieved seroprotection prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percent of participants who achieved seroprotection at Day 28 who were not seroprotected prior to vaccination.|Day 28 post vaccination|Subset of the per protocol population that were not seroprotected against influenza B at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations||percentage of participants|||Number
667554|NCT01737684|Secondary|Apparent Terminal Half-life (t½) After a Single Oral Dose of Vibegron 100 mg|Blood samples were collected for determination of vibegron levels predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours after dosing.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours postdose|PP population, which included participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of treatment, according to the underlying scientific model.||hr||Geometric Coefficient of Variation|Geometric Mean
667555|NCT01737684|Secondary|Time to Maximum Observed Plasma Drug Concentration (Tmax) After a Single Oral Dose of Vibegron 100 mg|Blood samples were collected for determination of vibegron levels predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours after dosing.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours postdose|PP population, which included participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of treatment, according to the underlying scientific model.||hr||Full Range|Median
667948|NCT01732835|Secondary|LVID Systole - Change From Baseline|Left ventricular internal dimension. Transthoracic echocardiography parameter.|Baseline and 6 months|Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.||cm||Standard Deviation|Mean
667557|NCT01737684|Secondary|Apparent Volume of Distribution During the Terminal Phase (Vd/F) After a Single Oral Dose of Vibegron 100 mg|Blood samples were collected for determination of vibegron levels predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours after dosing.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours postdose|PP population, which included participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of treatment, according to the underlying scientific model.||L||Geometric Coefficient of Variation|Geometric Mean
667558|NCT01737684|Secondary|Apparent Clearance (CL/F), Calculated as Dose/AUC0-∞, After a Single Oral Dose of Vibegron 100 mg|Blood samples were collected for determination of vibegron levels predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours after dosing.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours postdose|Per Protocol (PP) population, which included participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of treatment, according to the underlying scientific model.||L/hr||Geometric Coefficient of Variation|Geometric Mean
667559|NCT01737684|Primary|Area Under the Concentration Time Curve From 0 to Infinity (AUC0-∞) After a Single Oral Dose of Vibegron 100 mg|Blood samples were collected for determination of vibegron levels predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours after dosing.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours postdose|Per Protocol (PP) population, which included the subset of participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of treatment, according to the underlying scientific model.||uM•hr||95% Confidence Interval|Geometric Mean
667560|NCT01737593|Secondary|Postanesthesia Pain Score|Children's Hospital of Eastern Ontario pain scale (CHEOPS) is an observational scale for measuring postoperative pain in young children. The scale includes six categories of pain behavior: (Cry, facial, verbal, torso, touch, and legs). A score ranging from 0 to 2 or 1 to 3 is assigned to each activity and the summed score ranges between 4 and 13, with a higher score meaning more pain.|Prior to discharge, up to 3 hours after induction.|||units on a scale||Standard Deviation|Mean
667561|NCT01737593|Secondary|Postanesthesia Pain Score|Children's Hospital of Eastern Ontario pain scale (CHEOPS) is an observational scale for measuring postoperative pain in young children. The scale includes six categories of pain behavior: (Cry, facial, verbal, torso, touch, and legs). A score ranging from 0 to 2 or 1 to 3 is assigned to each activity and the summed score ranges between 4 and 13, with a higher score meaning more pain.|45 minutes post-emergence|Participants not yet discharged at the 45 minute time point||units on a scale||Standard Deviation|Mean
667562|NCT01737593|Secondary|Postanesthesia Pain Score|Children's Hospital of Eastern Ontario pain scale (CHEOPS) is an observational scale for measuring postoperative pain in young children. The scale includes six categories of pain behavior: (Cry, facial, verbal, torso, touch, and legs). A score ranging from 0 to 2 or 1 to 3 is assigned to each activity and the summed score ranges between 4 and 13, with a higher score meaning more pain.|30 minutes post-emergence|Participants not yet discharged at the 30 minute time point||units on a scale||Standard Deviation|Mean
667563|NCT01737593|Secondary|Postanesthesia Pain Score|Children's Hospital of Eastern Ontario pain scale (CHEOPS) is an observational scale for measuring postoperative pain in young children. The scale includes six categories of pain behavior: (Cry, facial, verbal, torso, touch, and legs). A score ranging from 0 to 2 or 1 to 3 is assigned to each activity and the summed score ranges between 4 and 13, with a higher score meaning more pain.|15 minutes post-emergence|Participants not yet discharged at the 15 minute time point||units on a scale||Standard Deviation|Mean
667564|NCT01737593|Secondary|Postanesthesia Pain Score|Children's Hospital of Eastern Ontario pain scale (CHEOPS) is an observational scale for measuring postoperative pain in young children. The scale includes six categories of pain behavior: (Cry, facial, verbal, torso, touch, and legs). A score ranging from 0 to 2 or 1 to 3 is assigned to each activity and the summed score ranges between 4 and 13, with a higher score meaning more pain.|5 minutes post-emergence|||units on a scale||Standard Deviation|Mean
667565|NCT01737593|Secondary|Postanesthesia Pain Score|Children's Hospital of Eastern Ontario pain scale (CHEOPS) is an observational scale for measuring postoperative pain in young children. The scale includes six categories of pain behavior: (Cry, facial, verbal, torso, touch, and legs). A score ranging from 0 to 2 or 1 to 3 is assigned to each activity and the summed score ranges between 4 and 13, with a higher score meaning more pain.|Emergence (spontaneous extremity movement)|||units on a scale||Standard Deviation|Mean
667566|NCT01737593|Secondary|Postanesthesia Pain Score|Children's Hospital of Eastern Ontario pain scale (CHEOPS) is an observational scale for measuring postoperative pain in young children. The scale includes six categories of pain behavior: (Cry, facial, verbal, torso, touch, and legs). A score ranging from 0 to 2 or 1 to 3 is assigned to each activity and the summed score ranges between 4 and 13, with a higher score meaning more pain.|Induction|||units on a scale||Standard Deviation|Mean
667567|NCT01737593|Primary|Postanesthesia Emergence Agitation (EA) Score|"EA was evaluated using the Pediatric Anesthesia Emergence Delirium (PAED) scale. This scale measures if the: 1. Child makes eye contact with the caregiver, 2. Child’s actions are purposeful, 3. Child is aware of his/her surroundings, 4. Child is restless, 5. Child is inconsolable.
Items 1, 2, and 3 are reversed scored as follows: 4 _ not at all, 3 _ just a little, 2 _ quite a bit, 1 _ very much, 0 _ extremely. Items 4 and 5 are scored as follows: 0 _ not at all, 1 _ just a little, 2 _ quite a bit, 3 _ very much, 4_extremely. Scores of each item are summed to obtain a total PAED scale score, range 0-20, with higher PAED scores indicating a greater degree of emergence delirium.
The average PAED score of all the time points is use"|Induction,Emergence(spontaneous extremity movement),and every 5 min after emergence until the patient is discharged. This is an average of 3 hours till discharge.|||units on a scale||Standard Deviation|Mean
667568|NCT01737021|Secondary|Hospital Anxiety and Depression Scale (HADS)|Validated measure of anxiety and depression in the parent.|3-6 months post discharge from PICU||||||
667569|NCT01737021|Secondary|Impact of Events Scale (IES)|Validated measure of post-traumatic stress symptoms in the parent.|3-6 months post discharge from PICU||||||
667677|NCT01736527|Primary|Tear Fluid Levels|Following a single dose of LE gel 0.5% administered into the study eye, tear samples will be collected via a Schirmer strip at 6, 9, 12 and 24 hours following the dose|12 hours|The primary analysis includes all subjects in the safety population with tear samples collected within the corresponding time window.||μg/g||Standard Deviation|Mean
667570|NCT01737021|Primary|The Number of Feasibility Criteria Successfully Met|"Feasibility success criteria have been defined a priori for the intervention and study design. There are six feasibility criteria related to the intervention, covering aspects of the timing of the intervention, compliance, and evaluation. There are also six feasibility criteria related to the study design, covering recruitment rate; participation rate; acceptability of procedures; attrition rate; and the time-scale of data collection.
Dependent on the number of criteria successfully met, the following classification will be used:
0-2/6 criteria met - Stop; intervention and/or study design not feasible.
3-4/6 criteria met - Continue with modifications; feasible intervention and/or study design with modifications.
5/6 criteria met - Continue without modifications, but monitor closely; feasible intervention and/or study design with close monitoring.
6/6 criteria met - Continue without modifications; feasible intervention and/or study design as is."|3-6 months post discharge from PICU|||Number of criteria successfully met|||Number
667571|NCT01736930|Primary|Mornings With Urine Ketones Characterized as Moderate or Large - Algorithm 3|The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as number of mornings with urine ketones characterized as moderate or large based on measurement results of a urine dipstick test taken using Ketostix. Moderate is considered approximately 30 - 40 mg/dL and Large >80 mg/dL.|21 days|||number of mornings|Participants||Number
667572|NCT01736930|Primary|Mornings With Urine Ketones Characterized as Moderate or Large - Algorithm 2|The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as number of mornings with urine ketones characterized as moderate or large based on measurement results of a urine dipstick test taken using Ketostix. Moderate is considered approximately 30 - 40 mg/dL and Large >80 mg/dL.|21 days|||number of mornings|Participants||Number
667573|NCT01736930|Primary|Mornings With Urine Ketones Characterized as Moderate or Large - Algorithm 1|The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as number of mornings with urine ketones characterized as moderate or large based on measurement results of a urine dipstick test taken using Ketostix. Moderate is considered approximately 30 - 40 mg/dL and Large >80 mg/dL.|21 days|||number of mornings|Participants||Number
667574|NCT01736930|Primary|Mornings With Blood Ketones >0.6 mmol/L - Algorithm 3|The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as number of mornings with blood ketones >0.6 mmol/L.|21 days|||number of mornings|Participants||Number
667575|NCT01736930|Primary|Mornings With Blood Ketones >0.6 mmol/L - Algorithm 2|The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as number of mornings with blood ketones >0.6 mmol/L.|21 days|||number of mornings|Participants||Number
667576|NCT01736930|Primary|Mornings With Blood Ketones >0.6 mmol/L - Algorithm 1|The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as number of mornings with blood ketones >0.6 mmol/L.|21 days|||number of mornings|Participants||Number
667577|NCT01736930|Primary|Percent Morning Blood Glucose >250 mg/dL - Algorithm 3|The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as overall percentage of mornings glucose measured with home glucose meter >250 mg/dL.|21 days|||percentage of mornings|Participants||Number
667578|NCT01736930|Primary|Percent Morning Blood Glucose >250 mg/dL - Algorithm 2|The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as overall percentage of mornings glucose measured with home glucose meter >250 mg/dL.|21 days|||percentage of mornings|Participants||Number
667579|NCT01736930|Secondary|Percentage of Sensor Glucose Values 71 to 180 mg/dL - Algorithm 3||Overnight from system activation to deactivation in the morning upon awakening for 21 nights of system use|||percentage of sensor glucose values|Participants|Inter-Quartile Range|Median
667580|NCT01736930|Secondary|Percentage of Sensor Glucose Values 71 to 180 mg/dL - Algorithm 2||Overnight from system activation to deactivation in the morning upon awakening for 21 nights of system use|||percentage of sensor glucose values|Participants|Inter-Quartile Range|Median
667581|NCT01736930|Secondary|Percentage of Sensor Glucose Values 71 to 180 mg/dL - Algorithm 1||Overnight from system activation to deactivation in the morning upon awakening for 21 nights of system use|||percentage of sensor glucose values|Participants|Inter-Quartile Range|Median
667582|NCT01736930|Secondary|Mean Sensor Glucose Overnight - Algorithm 3||Overnight from system activation to deactivation in the morning upon awakening for 21 nights of system use|||mg/dl|Participants|Standard Deviation|Mean
667583|NCT01736930|Secondary|Mean Sensor Glucose Overnight - Algorithm 2||Overnight from system activation to deactivation in the morning upon awakening for 21 nights of system use|||mg/dl|Participants|Standard Deviation|Mean
667584|NCT01736930|Secondary|Mean Sensor Glucose Overnight - Algorithm 1||Overnight from system activation to deactivation in the morning upon awakening for 21 nights of system use|||mg/dl|Participants|Standard Deviation|Mean
667585|NCT01736930|Primary|Percent Morning Blood Glucose >250 mg/dL - Algorithm 1|The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as the overall percentage of mornings glucose measured with home glucose meter >250 mg/dL.|21 days|||percentage of mornings|Participants||Number
667586|NCT01736930|Primary|Mean Morning Blood Glucose (mg/dL)- Algorithm 3|"The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as mean morning blood glucose (mg/dL).
The hypoglycemia prediction horizon was reduced further in algorithm 3 to 30 minutes. A total of 114 study nights (37 Control nights and 77 Intervention nights) using algorithm 3."|21 study nights|||mg/dl|Participants|Standard Deviation|Mean
667949|NCT01732835|Secondary|LVID Diastole - Change From Baseline|Left ventricular internal dimension. Transthoracic echocardiography parameter.|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.||cm||Standard Deviation|Mean
667587|NCT01736930|Primary|Mean Morning Blood Glucose (mg/dL)- Algorithm 2|"The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as mean morning blood glucose (mg/dL).
Algorithm 1 was modified to reduce the hypoglycemia prediction horizon from 70 minutes to 50 minutes, to suspend the pump only when the continuous glucose monitor sensor glucose value was ≤ 230 mg/dl, not suspend if there was a drop of >40 mg/dl in consecutive sensor glucose readings, and to resume insulin delivery at the first rise in sensor glucose following a suspension. There was 156 nights of study data collected (48 Control nights and 108 Intervention nights) using algorithm 2."|21 study nights|||mg/dl|Participants|Standard Deviation|Mean
667588|NCT01736930|Primary|Mean Morning Blood Glucose (mg/dL)- Algorithm 1|"The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as mean morning blood glucose (mg/dL).
An objective was to evaluate and refine the control algorithm. The data were reviewed periodically during the study with the pre-stated goal of determining whether any changes should be made in the control algorithm. Algorithm 1 was used for the first 105 nights of the study (38 Control nights and 67 Intervention nights). The horizon prediction time of algorithm 1 was set at 70 minutes."|21 study nights|||mg/dl|Participants|Standard Deviation|Mean
667589|NCT01736917|Secondary|Self-Reported Assessment of Nausea|"the patient’s self-reported assessment of nausea Days 1-8 using a 0-100mm visual analog scale (VAS) median.
The Visual Analouge (VAS) 100mm Scale Score for Chemotherapy Induced Nausea and Vomiting (CINV). Participants were asked to mark a linear scale 100mm in length representing their level of nausea with 0mm indicating no nausea and 100mm indicating severe nausea. Median VAS scores (in mm) are reported, per day."|Days 1-8 of chemotherapy regimen|54 patients completed the VAS on all 8 days and were eligible for analysis.||millimeters||Full Range|Median
667590|NCT01736917|Secondary|Use of Rescue Medications.|Total number of patients who received rescue medications.|Days 1-8 of chemotherapy regimen|||participants|||Number
667591|NCT01736917|Secondary|Total Number of Emetic Episodes|total number of emetic episodes|Days 1-8 of chemotherapy regimen|||episodes|||Number
667592|NCT01736917|Primary|Percentage of Participants With Complete Response of Acute and Delayed Chemotherapy Induced Nausea and Vomiting|complete response (CR) of both acute (days 1 through 5) and delayed (days 6 through 8) CINV, defined by no emetic episodes or use of rescue medications|Days 1-8 of chemotherapy regimen|||percentage of participants|||Number
667593|NCT01736696|Secondary|Gene Expression in Peripheral Blood|Punch biopsy and serum blood were assayed for messenger Ribonucleic acid (mRNA) gene expression by quantitative PCR using standard curve(SC) method generated by linear regression using log threshold cycle versus log(cell number). granzyme B, IFN-gamma, TNF-alpha (FasL and superfamily member 5 [SF5]), BCL2, BAX, iNOS, and CD 25 presented as control gene normalized expression(relative expression) within SC. The Relative mRNA Gene Expression Level is relative to baseline and normalized to the housekeeping gene 18 Svedberg unit ribosomal RNA (18S rRNA).|Day 14|Analysis population:all participants who met eligibility criteria. 'N'(number of participants analyzed)=participants evaluable for this measure. ‘n =participants evaluable for specified category for each arm group respectively. Gene expression results were planned to be analyzed for participants who received CP-690,550 5,30 mg and matching placebo.||relative expression unit (REU)||Standard Deviation|Mean
667594|NCT01736696|Secondary|Number of Participants With Intracellular Adhesion Molecule (ICAM-1) by Epidermal Keratinocytes Expression|Immunohistochemical staining of skin biopsies was performed with monoclonal antibodies directed against ICAM-1. Number of participants with ICAM-1 expression was to be assessed qualitatively using epidermal keratinocytes.|Baseline (within 7 days prior to Day 1) up to Day 14|Analysis of ICAM-1 in biopsy specimens was not performed as it often continues to be expressed on vessels in the skin even when psoriasis was resolved, thus would not provide a measure of response to therapy.|||||
667595|NCT01736696|Secondary|Number of Participants With Keratin 16 (K16) Expression|Immunohistochemical staining of skin biopsies was performed with monoclonal antibodies directed against K16. Number of participants with K16 expression were assessed qualitatively using suprabasal keratinocytes.|Baseline (within 7 days prior to Day 1) up to Day 14|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||participants|||Number
667596|NCT01736696|Secondary|Immunohistochemistry From Psoriatic Plaque Biopsies|Immunohistochemical staining of skin biopsies was performed with monoclonal antibodies directed against cluster of differentiation 3 (CD3) and cluster of differentiation 8 (CD8) T-lymphocytes, cluster of differentiation 16/56 (CD16/56) natural killer cells, and cluster of differentiation 83 (CD83) mature dendritic cells. Baseline was defined as mean of samples obtained at the screening visit within 7 days prior to Day 1, at the baseline biopsy, and Day 0. Immunohistochemistry results were planned to be analyzed for participants who received CP-690,550 5, 20, 30 mg and matching placebo.|Baseline (within 7 days prior to Day 1), Day 14|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure. ‘n’ = participants evaluable for this measure at specified time points for each arm group respectively.||cells/microliter (cells/μL)||Standard Deviation|Mean
667597|NCT01736696|Secondary|Gene Expression in Psoriatic Plaque Biopsies|Gene expression by quantitative polymerized chain reaction (PCR) using standard curve (SC) method generated by linear regression using log threshold cycle versus log(cell number). Keratin (K)-16, inducible nitric oxide synthase (iNOS), Interleukin 8 (IL-8), CD25, Granzyme B, IL-2, IL-7, IL-15, Interferon-gamma (INF-gamma), C-X-C motif chemokine(CXCL10), perforin 1, B-cell Lymphoma 2 (BCL-2), BCL2 associated X Protein (BAX), Tumor Necrosis Factor Fas Ligand (TNF-FasL), and proliferating cell nuclear antigen (PCNA) presented as control gene normalized expression (relative expression) within SC.|Day 14|Analysis population:all participants who met eligibility criteria. 'N'(number of participants analyzed)=participants evaluable for this measure. ‘n =participants evaluable for specified category for each arm group respectively. Gene expression results were planned to be analyzed for participants who received CP-690,550 5,30 mg and matching placebo.||relative expression unit (REU)||Standard Deviation|Mean
667678|NCT01736527|Primary|Tear Fluid Levels|Following a single dose of LE gel 0.5% administered into the study eye, tear samples will be collected via a Schirmer strip at 6, 9, 12 and 24 hours following the dose|9 hours|The primary analysis includes all subjects in the safety population with tear samples collected within the corresponding time window.||μg/g||Standard Deviation|Mean
667598|NCT01736696|Secondary|Number of Participants With Physician’s Global Assessment (PGA) of Psoriasis|Physician global assessment (PGA) of Psoriasis is a 7-point scale used to assess severity of psoriatic plaques, scaling and/or erythema. Severity scale ranged from 1 to 7: 1=severe, 2=moderate to severe, 3=moderate, 4=mild to moderate, 5=mild, 6=almost clear, 7=clear (no sign of psoriasis).|Baseline (Within 7 days prior to Day 1) up to Day 14|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure.||participants|||Number
667599|NCT01736696|Secondary|Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14|Modified Psoriasis Area and Severity Index (mPASI) assessed lesion severity but not the body surface area affected. Severity was estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final mPASI = sum of the each component scores. Total score range 0-12 , higher score indicated more severity.|Baseline (Within 7 days prior to Day 1) up to Day 14|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure.||participants|||Number
667600|NCT01736696|Primary|Half Maximal Effective Area Under the Concentration-Time Curve 50 (EAUC 50)|EAUC 50 was calculated from a regression analyses using area under the concentration-time curve (AUC) as the independent variable. A sigmoid maximum effect (Emax) model was used to explain the relationship between AUC and modified Psoriasis Severity Index (mPASI) score, where Emax was the maximum effect (100 percent reduction in the total mPASI score from baseline), and EAUC 50 was the AUC where 50 percent of the maximum effect was measured.|Day 14|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||ng*hr/mL|||Number
667601|NCT01736696|Primary|Time to Reach Maximum Change From Baseline and Time to Return to Baseline Value for Fluorescence-Activated Cell Sorting (FACS), Reticulocyte Counts and Immune Cell Function||Day 0 (pre-dose), 1, 2, 4, 7, 10, 14, 15, 18, 21, 28, 42|Data was not analyzed as per planned analyses due to pattern of changes observed.|||||
667602|NCT01736696|Primary|Change From Baseline in Reticulocyte Count at Day 42|Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.|Baseline (Within 7 days prior to Day 1), Day 42|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||1000 cells/mm^3||Standard Deviation|Mean
667603|NCT01736696|Primary|Change From Baseline in Reticulocyte Count at Day 28|Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.|Baseline (Within 7 days prior to Day 1), Day 28|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||1000 cells/mm^3||Standard Deviation|Mean
667604|NCT01736696|Primary|Change From Baseline in Reticulocyte Count at Day 21|Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.|Baseline (Within 7 days prior to Day 1), Day 21|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||1000 cells/mm^3||Standard Deviation|Mean
667605|NCT01736696|Primary|Change From Baseline in Reticulocyte Count at Day 15|Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.|Baseline (Within 7 days prior to Day 1), Day 15|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||1000 cells/mm^3||Standard Deviation|Mean
667606|NCT01736696|Primary|Change From Baseline in Reticulocyte Count at Day 10|Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.|Baseline (Within 7 days prior to Day 1), Day 10|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||1000 cells/mm^3||Standard Deviation|Mean
667607|NCT01736696|Primary|Change From Baseline in Reticulocyte Count at Day 7|Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.|Baseline (Within 7 days prior to Day 1), Day 7|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||1000 cells/mm^3||Standard Deviation|Mean
667608|NCT01736696|Primary|Change From Baseline in Reticulocyte Count at Day 4|Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.|Baseline (Within 7 days prior to Day 1), Day 4|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||1000 cells/mm^3||Standard Deviation|Mean
667609|NCT01736696|Primary|Change From Baseline in Reticulocyte Count at Day 2|Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.|Baseline (Within 7 days prior to Day 1), Day 2|Analysis population included all participants who met the eligibility criteria. ‘n’ = participants evaluable for this measure at specified time points for each arm group respectively.||1000 cells/cubic millimeter (cells/mm^3)||Standard Deviation|Mean
667610|NCT01736696|Primary|Change From Baseline in Immune Cell Function at Day 14|The degree of immunosuppression induced by the study drug administration was evaluated using a bioluminescent assay in which the concentration of Adenosine-5-Triphosphate (ATP) released by CD4 cells was measured. ATP concentrations released from stimulated and unstimulated cells were evaluated. ATP Concentration less than or equal to (<=) 225: low immune cell response, 226 to 524: Moderate immune cell response, >= 525: strong immune cell response. Baseline was defined as the mean of the samples collected during the pre-dose biopsy.|Baseline (Within 7 days prior to Day 1), Day 14|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure. ‘n’ = participants evaluable for this measure at specified time points for each arm group respectively.||ng/mL||Standard Deviation|Mean
667679|NCT01736527|Primary|Tear Fluid Levels|Following a single dose of LE gel 0.5% administered into the study eye, tear samples will be collected via a Schirmer strip at 6, 9, 12 and 24 hours following the dose|6 hours|The primary analysis includes all subjects in the safety population with tear samples collected within the corresponding time window.||μg/g||Standard Deviation|Mean
667611|NCT01736696|Primary|Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42|Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.|Baseline, hr 0 on Day 42|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure.||percent change||Standard Deviation|Mean
667612|NCT01736696|Primary|Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28|Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.|Baseline, hr 0 on Day 28|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure.||percent change||Standard Deviation|Mean
667613|NCT01736696|Primary|Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21|Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.|Baseline, hr 0 on Day 21|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure.||percent change||Standard Deviation|Mean
667614|NCT01736696|Primary|Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18|Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.|Baseline, Hour 0 on Day 18|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure.||percent change||Standard Deviation|Mean
667615|NCT01736696|Primary|Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14|Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.|Baseline; hr 0, 8 hr post-dose on Day 14|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure.||percent change||Standard Deviation|Mean
667616|NCT01736696|Primary|Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10|Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.|Baseline, hr 0 on Day 10|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure.||percent change||Standard Deviation|Mean
667617|NCT01736696|Primary|Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7|Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.|Baseline, hr 0 on Day 7|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure.||percent change||Standard Deviation|Mean
667618|NCT01736696|Primary|Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4|Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.|Baseline, hr 0 on Day 4|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure.||percent change||Standard Deviation|Mean
667956|NCT01732835|Secondary|Peak Gradient - Change From Baseline|Transthoracic echocardiography parameter|Baseline and 6 months|Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.||mm Hg||Standard Deviation|Mean
667619|NCT01736696|Primary|Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2|Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.|Baseline, hr 0 on Day 2|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure.||percent change||Standard Deviation|Mean
667620|NCT01736696|Primary|Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1|Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.|Baseline, 1 hr post-dose on Day 1|Analysis population included all participants who met the eligibility criteria.||percent change||Standard Deviation|Mean
667621|NCT01736696|Primary|Accumulation Ratio (R0)|Accumulation ratio was calculated as, R0 = area under the curve from time zero to end of dosing interval (AUCtau) on Day 14 divided by area under the curve from time zero to end of dosing interval (AUCtau) on Day 1.|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12 hrs post dose on Day 1 and Day 14|Pharmacokinetic analysis population included all participants who met the eligibility criteria and had 1 post-baseline pharmacokinetic assessment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||Ratio||Standard Deviation|Mean
667622|NCT01736696|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) at Day 14||0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12 hrs post dose on Day 14|Pharmacokinetic analysis population included all participants who met the eligibility criteria and had 1 post-baseline pharmacokinetic assessment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||hr||Full Range|Median
667623|NCT01736696|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) at Day 1||0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12 hrs post dose on Day 1|Pharmacokinetic analysis population included all participants who met the eligibility criteria and had 1 post-baseline pharmacokinetic assessment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||hr||Full Range|Median
667624|NCT01736696|Primary|Maximum Observed Plasma Concentration (Cmax) at Day 14||0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12 hrs post dose on Day 14|Pharmacokinetic analysis population included all participants who met the eligibility criteria and had 1 post-baseline pharmacokinetic assessment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||ng/mL||Standard Deviation|Mean
667625|NCT01736696|Primary|Maximum Observed Plasma Concentration (Cmax) at Day 1||0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12 hrs post dose on Day 1|Pharmacokinetic analysis population included all participants who met the eligibility criteria and had 1 post-baseline pharmacokinetic assessment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
667626|NCT01736696|Primary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) at Day 14|AUCtau = area under the curve from time zero to end of dosing interval.|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12 hrs post dose on Day 14|Pharmacokinetic analysis population included all participants who met the eligibility criteria and had 1 post-baseline pharmacokinetic assessment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||ng*hr/mL||Standard Deviation|Mean
667627|NCT01736696|Primary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) at Day 1|AUCtau = area under the curve from time zero to end of dosing interval.|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12 hrs post dose on Day 1|Pharmacokinetic analysis population included all participants who met the eligibility criteria and had 1 post-baseline pharmacokinetic assessment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||nanogram*hour/milliliter (ng*hr/mL)||Standard Deviation|Mean
667628|NCT01736696|Primary|Number of Participants With Corrected QT (QTc) Interval Greater Than or Equal to 500 Millisecond|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia’s formula (QTcF = QT divided by cube root of RR) and by Bazette’s formula (QTcB = QT divided by square root of RR). Participants with maximum QTc >=500 msec were reported.|1, 2, 4, 8, 12 hrs post dose, additional 16 hrs post dose for 60 mg once daily group on Day 1; 1, 2 hrs post dose on Day 4, 7, 10;1,2,4,8,12 hrs post dose on Day 14; Day 21|Analysis population included all participants who met the eligibility criteria.||participants|||Number
667629|NCT01736696|Primary|Number of Participants With Increase From Baseline in Corrected QT (QTc) Interval|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia’s formula (QTcF = QT divided by cube root of RR) and by Bazette’s formula (QTcB = QT divided by square root of RR). Participants with maximum increase from baseline of 30 to less than (<) 60 msec(borderline) and greater than or equal to (>=) 60 msec (prolonged) were summarized.|1, 2, 4, 8, 12 hrs post dose, additional 16 hrs post dose for 60 mg once daily group on Day 1; 1, 2 hrs post dose on Day 4, 7, 10;1,2,4,8,12 hrs post dose on Day 14; Day 21|Analysis population included all participants who met the eligibility criteria.||participants|||Number
667680|NCT01736475|Secondary|Changes in Lipid Panel Assessments From Screening – Cholesterol; High Density Lipoprotein (HDL); Low Density Lipoprotein (LDL); Triglycerides; and Very Low Density Lipoprotein (VLDL)||Screening, week 2, week 4, month 3, study completion/termination|Safety Analysis Set - Subset of participants with both screening visit data and follow on time point data.||mmol/L||Inter-Quartile Range|Median
667630|NCT01736696|Primary|Change From Baseline in QT Interval at 12 Hour Post Morning Dose (HPD 12) on Day 14|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles.For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.|12 hrs prior to morning dose on Day 1 (Baseline for HPD 12), 12 hrs post morning dose on Day 14|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||msec||Standard Deviation|Mean
667631|NCT01736696|Primary|Change From Baseline in QT Interval at 8 Hour Post Morning Dose (HPD 8) on Day 14|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles.For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.|16 hrs prior to morning dose on Day 1 (Baseline for HPD 8), 8 hrs post morning dose on Day 14|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||msec||Standard Deviation|Mean
667632|NCT01736696|Primary|Change From Baseline in QT Interval at 4 Hour Post Morning Dose (HPD 4) on Day 14|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles.For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.|20 hrs prior to morning dose on Day 1 (Baseline for HPD 4), 4 hrs post morning dose on Day 14|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||msec||Standard Deviation|Mean
667633|NCT01736696|Primary|Change From Baseline in QT Interval at 2 Hour Post Morning Dose (HPD 2) on Day 14|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles.For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.|22 hrs prior to morning dose on Day 1 (Baseline for HPD 2), 2 hrs post morning dose on Day 14|Analysis population included all participants who met the eligibility criteria.'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||msec||Standard Deviation|Mean
667634|NCT01736696|Primary|Change From Baseline in QT Interval at 1 Hour Post Morning Dose (HPD 1) on Day 14|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles.For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.|23 hrs prior to morning dose on Day 1 (Baseline for HPD 1), 1 hr post morning dose on Day 14|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||msec||Standard Deviation|Mean
667635|NCT01736696|Primary|Change From Baseline in QT Interval at 0 Hour Post Morning Dose (HPD 0) on Day 14|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles. The mean of the triplicates at HPD=0 on Day 1 will be defined as the baseline for HPD=0.|Hour 0 (pre-dose) on Day 1 (Baseline for HPD 0), 0 hr on Day 14|Analysis population included all participants who met the eligibility criteria.||msec||Standard Deviation|Mean
667636|NCT01736696|Primary|Change From Baseline in QT Interval at 16 Hour Post Morning Dose (HPD 16) on Day 1|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles.For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.Change from baseline in QT interval at HPD 16 was planned to be analyzed for participants who received CP-690,550 60 mg and matching placebo.|8 hrs prior to morning dose on Day 1 (Baseline for HPD 16), 16 hrs post morning dose on Day 1|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||msec||Standard Deviation|Mean
667637|NCT01736696|Primary|Change From Baseline in QT Interval at 12 Hour Post Morning Dose (HPD 12) on Day 1|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles.For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.|12 hrs prior to morning dose on Day 1 (Baseline for HPD 12), 12 hrs post morning dose on Day 1|Analysis population included all participants who met the eligibility criteria. Here, the ‘n’ is signifying those participants who were evaluable for this measure at the specified time point for each arm group.||msec||Standard Deviation|Mean
667638|NCT01736696|Primary|Change From Baseline in QT Interval at 8 Hour Post Morning Dose (HPD 8) on Day 1|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles.For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.|16 hrs prior to morning dose on Day 1 (Baseline for HPD 8), 8 hrs post morning dose on Day 1|Analysis population included all participants who met the eligibility criteria. Here, the ‘n’ is signifying those participants who were evaluable for this measure at the specified time point for each arm group.||msec||Standard Deviation|Mean
667681|NCT01736475|Secondary|Changes in Hematology Laboratory Assessments From Screening – Erythrocytes||Screening, week 2, week 4, month 3, study completion/termination|Safety Analysis Set - Subset of participants with both screening visit data and follow on time point data.||TI/L||Inter-Quartile Range|Median
667639|NCT01736696|Primary|Change From Baseline in QT Interval at 4 Hour Post Morning Dose (HPD 4) on Day 1|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles. For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.|20 hrs prior to morning dose on Day 1 (Baseline for HPD 4), 4 hrs post morning dose on Day 1|Analysis population included all participants who met the eligibility criteria. Here, the ‘n’ is signifying those participants who were evaluable for this measure at the specified time point for each arm group.||msec||Standard Deviation|Mean
667640|NCT01736696|Primary|Change From Baseline in QT Interval at 2 Hour Post Morning Dose (HPD 2) on Day 1|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles. For each scheduled hour post morning dose (HPD), except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.|22 hrs prior to morning dose on Day 1 (Baseline for HPD 2), 2 hrs post morning dose on Day 1|Analysis population included all participants who met the eligibility criteria.||msec||Standard Deviation|Mean
667641|NCT01736696|Primary|Change From Baseline in QT Interval at 1 Hour Post Morning Dose (HPD 1) on Day 1|Triplicate 12-lead electrocardiogram (ECG) measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles. For each scheduled hour post morning dose (HPD), except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.|23 hours (hrs) prior to morning dose on Day 1 (Baseline for HPD 1), 1 hour (hr) post morning dose on Day 1|Analysis population included all participants who met the eligibility criteria.||millisecond (msec)||Standard Deviation|Mean
667642|NCT01736657|Secondary|Device-related Serious Adverse Events (SAE) in the Full Analysis Set|Device-related serious adverse events (SAE) in the Full Analysis Set (72 patients).|upon signing consent to 24 hours post-procedure|Seventy-three enrolled: 12 were lead-in patients whereby Optia Operators completed their training and data from those procedures were not included in the efficacy analysis (60 patients), but these patients were included in safety analysis as Full Analysis Set; 1 patient was consented but withdrawn prior to procedure due to lack of vascular access.||participants|||Number
667643|NCT01736657|Secondary|Spectra Optia System’s Ability to Achieve the Desired Final Hematocrit in the Evaluable Population|Measurement of the patient post-procedure hematocrit compared to the final target hematocrit calculated by the Spectra Optia Apheresis System. Final target hematocrit was calculated by tracking the number of red cells coming into the system versus the number of red cells removed.|Length of the procedure|60 patients analyzed, 73 enrolled:12 patients were lead-in patients whereby Optia Operators completed their training and data from those procedures were not included in the efficacy analysis (60 pts), but were included in the safety analysis (72 patients); 1 patient was consented but withdrawn prior to procedure due to lack of vascular access.||ratio||95% Confidence Interval|Mean
667644|NCT01736657|Secondary|Procedural Success of the Spectra Optia System in the Evaluable Population|The procedural success of the Spectra Optia System is defined as the ability of the device to complete a red blood cell exchange (RBCx) and to obtain a satisfactory exchange by lowering the patient's hemoglobin S, as determined by the investigator in the evaluable population (60 pts).|Length of the procedure|60 patients analyzed, 73 enrolled:12 patients were lead-in patients whereby Optia Operators completed their training and data from those procedures were not included in the efficacy analysis (60 pts), but were included in the safety analysis (72 patients); 1 patient was consented but withdrawn prior to procedure due to lack of vascular access.||percentage of participants|||Number
667645|NCT01736657|Primary|Mean Ratio Actual Fraction of Cells Remaining (FCRa; as Measured by Post-Procedure % HbS) to the Predicted Fraction of Cells Remaining (FCRp; as Predicted by the Spectra Optia System FCR Algorithm Multiplied by the Pre-Procedure % HbS)|The primary endpoint evaluated the mean ratio of the Actual Fraction of Cells Remaining (FCRa: as measured by Post-Procedure % HbS) to the Predicted Fraction of Cells Remaining (FCRp: as predicted by the Spectra Optia system FCR algorithm multiplied by the Pre-Procedure % HbS), in the evaluable population (60 pts). The pre-defined range for the mean ratio of the FCRa to the FCRp was 0.75 to 1.25.|Length of the procedure|60 patients analyzed, 73 enrolled:12 patients were lead-in patients whereby Optia Operators completed their training and data from those procedures were not included in the efficacy analysis (60 pts), but were included in the safety analysis (72 patients); 1 patient was consented but withdrawn prior to procedure due to lack of vascular access.||ratio||95% Confidence Interval|Mean
674023|NCT01656252|Secondary|Phase II- Platelet Transfusion Requirements|To determine the impact of eltrombopag on platelet transfusion requirements in the setting of consolidation chemotherapy.|62 months||||||
667661|NCT01736540|Secondary|Investigator Treatment Decisions Based on MRI Results|"Treatment decisions were recorded after the investigator evaluated the MRI results, in order to assess the impact of such diagnostic test on the overall clinical management of participants with iron overload. Investigators answered the following question: Since the MRI scan, have you changed or are planning to change the management of iron in your subject?."|2 months|Participants, for whom treatment decision questionnaire results were provided and for whom MRI results were available, were included in the analysis.||Percentage of participants|||Number
667682|NCT01736475|Secondary|Changes in Hematology Laboratory Assessments From Screening – Hemoglobin||Screening, week 2, week 4, month 3, study completion/termination|Safety Analysis Set - Subset of participants with both screening visit data and follow on time point data.||g/L||Inter-Quartile Range|Median
667683|NCT01736475|Secondary|Changes in Hematology Laboratory Assessments From Screening – Hematocrit||Screening, week 2, week 4, month 3, study completion/termination|Safety Analysis Set - Subset of participants with both screening visit data and follow on time point data.||Percentage red blood cells||Inter-Quartile Range|Median
667662|NCT01736540|Secondary|Percentage of Participants With Low Medium or High Adherence to Iron Chelator Therapy|"Adherence of participants was assessed using an adherence questionnaire. Adherence questionnaires were completed only by participants who received chelating agents. Participants answered yes or no to 6 statements such as Forgot to take pills. Based on the responses to these questions, adherence was classified as low, medium or high."|1 month|Participants who were on iron chelator therapy at screening, and had answered at least one question on the questionnaire and had sufficient information to score the questionnaire, were included in the analysis.||Percentage of participants|||Number
667663|NCT01736540|Secondary|Mean Quality of Life (QOL) Scores|Quality of life was assessed using the Short Form 36 (SF-36) Health Survey. The SF-36 consists of 8 sub-scales: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. The raw sores of the 8 scales are transformed to a 0 - 100 scale where 0 indicates maximum disability and 100 indicates no disability. There also are two physical and mental health summary measures. Each summary measure is the mean average of the 4 associated sub-scale scores. The range for each summary measure is 0 to 100 where 0 represents maximum disability and 100 represents no disability.|1 month|Only participants with data for each subscale were included in the analysis for that subscale.||units on a scale||Standard Deviation|Mean
667664|NCT01736540|Secondary|Mean Number of Erythrocyte Units Transfused in Last 12 Months|Transfusion requirement in participants with acquired anaemias with history of receiving chelation therapy was assessed.|12 months - retrospective|Participants with 'number of units transfused' data were included in the analysis.||number of units transfused||Standard Deviation|Mean
667665|NCT01736540|Secondary|Percentage of Participants With Time Since Most Recent Transfuison of <7 Days, 7 to < 14 Days, 14 to < 30 Days, 30 to < 60 Days or >= 60 Days|Transfusion requirement in participants with acquired anaemias with history of receiving chelation therapy was assessed.|12 months - retrospective|Participants with data on time since their most recent transfusion were included in the analysis.||percentage of participants|||Number
667666|NCT01736540|Secondary|Percentage of Participants Transfused With Erythrocytes|Transfusion requirement in participants with acquired anaemias with history of receiving chelation therapy was assessed.|12 months - retrospective|Participants with a erythrocyte transfusion history were included in the analysis.||Percentage of participants|||Number
667667|NCT01736540|Secondary|Mean Blood Magnetic Susceptibility (BMS)|Blood samples were collected to assess BMS. The measurement represents absolute magnetic susceptibility at 1 month. Whole blood magnetic susceptibility was calculated by the addition of the dry weight susceptibility and the contribution of the water driven from the sample.|1 month|Participants with BMS values were analyzed.||emu/g wet wt/Oe||Standard Deviation|Mean
667668|NCT01736540|Secondary|Mean LIC According to the Presence or Absence of Retrospective Hepatic Events|Mean LIC according to the presence or absence of hepatic events was assessed for all participant subgroups.|12 months - retrospective|Participants with LIC by MRI were included in the analysis.||mg Fe/g||Standard Deviation|Mean
667669|NCT01736540|Secondary|Mean Cardiac T2* According to the Presence or Absence of Retrospective Cardiac Events|Mean cardiac T2* according to the presence or absence of cardiac events was assessed for all participant subgroups. The mean data presented are mean estimates of log transformed data.|12 months - retrospective|Participants with valid T2* by MRI results were included in the analysis.||log10 (ms)||Standard Deviation|Mean
667670|NCT01736540|Secondary|Mean Serum Ferritin According to the Presence or Absence of Retrospective Hepatic Events|Mean serum ferritin according to the presence or absence of hepatic events was assessed for all participant subgroups.|12 months - retrospective|Participants with serum ferritin values and previous hepatic events data were included in the analysis.||ng/mL||Standard Deviation|Mean
667671|NCT01736540|Secondary|Mean Serum Ferritin According to the Presence or Absence of Retrospective Cardiac Events|Mean serum ferritin according to the presence or absence of cardiac events was assessed for all participant subgroups.|12 months - retrospective|Participants with serum ferritin values and previous cardiac events data were included in the analysis.||ng/mL||Standard Deviation|Mean
667672|NCT01736540|Secondary|Comparison of Liver Iron Concentration (LIC) Levels to Evaluate Iron Overload Due to Transfusion Therapy in Chelation-naïve and Chelation-treated Participant Subgroups|Iron overload due to transfusion therapy was assessed based on chelation status of each participant (i.e. minimally exposed to chelator treatment and chelation-treated patient subgroups). The mean data presented are mean estimates of log transformed data.|2 months|Only participants with valid LIC by MRI were included in the analysis.||mg Fe/g||95% Confidence Interval|Mean
667673|NCT01736540|Secondary|Comparison of T2* Levels to Evaluate the Severity of Iron Overload Due to Transfusion Therapy in Chelation-naïve and Chelation-treated Participant Subgroups|Iron overload due to transfusion therapy was assessed based on chelation status of each participant (i.e. minimally exposed to chelator treatment and chelation-treated patient subgroups).|2 months|Only participants with valid T2* by MRI were included in the analysis.||ms||95% Confidence Interval|Least Squares Mean
667674|NCT01736540|Primary|Cardiac Siderosis Severity|Cardiac siderosis severity was measured by MRI (T2*). The severity grade of siderosis was tiered in 3 levels: mild (T2* >= 20ms), moderate (T2* from 10 to 20ms), and severe (T2* <10ms). Mild cardiac siderosis, by the definitions used in this study, were equivalent to not having cardiac siderosis. Values were compared to published thresholds of iron overload to determine severity of transfusion siderosis in the participant population studied.|2 months|Only participants with valid T2* by MRI were included in the analysis.||Percentage of participants|||Number
667675|NCT01736540|Primary|Percentage of Participants With Cardiac and Liver Iron Overload.|Hepatic iron overload (liver siderosis) and cardiac iron overload (cardiac siderosis) in patients with transfusional siderosis (Myelodysplastic syndrome (MDS), thalassaemia major, non-transfusion-dependent thalassaemia (NTDT) and other anaemias) were measured using MRI (R2 by FerriScan and T2*, respectively).|2 months|Only participants with valid T2* by MRI and valid liver iron concentration (LIC) by MRI were included for the cardiac siderosis and liver siderosis analyses, respectively.||Percentage of participants|||Number
667676|NCT01736527|Primary|Tear Fluid Levels|Following a single dose of LE gel 0.5% administered into the study eye, tear samples will be collected via a Schirmer strip at 6, 9, 12 and 24 hours following the dose|24 hours|The primary analysis includes all subjects in the safety population with tear samples collected within the corresponding time window.||μg/g||Standard Deviation|Mean
667686|NCT01736475|Secondary|Changes in Clinical Chemistry Laboratory Assessments From Screening - Bicarbonate, Chloride, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN)||Screening, week 2, week 4, month 3, study completion/termination|Safety Analysis Set - Subset of participants with both screening visit data and follow on time point data.||mmol/L||Inter-Quartile Range|Median
667687|NCT01736475|Secondary|Changes in Clinical Chemistry Laboratory Assessments From Screening - Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase|Alkaline Phosphatase (Alk Phos); Alanine Aminotransferase (Ala Amino); Aspartate Aminotransferase (Asp Amino)|Screening, week 2, week 4, month 3, study completion/termination|Safety Analysis Set - Subset of participants with both screening visit data and follow on time point data.||Units per Liter||Inter-Quartile Range|Median
667688|NCT01736475|Secondary|Changes in Clinical Chemistry Laboratory Assessments From Screening - Albumin and Protein||Screening, week 2, week 4, month 3, study completion/termination|Safety Analysis Set - Subset of participants with both screening visit data and follow on time point data.||g/L||Inter-Quartile Range|Median
667689|NCT01736475|Secondary|Changes in Vital Signs From Screening - Blood Pressure|Systolic Blood Pressure (SBP) Diastolic Blood Pressure (DBP)|Screening, week 2, week 4, exposure day 10-15, month 3, study completion/termination|Safety Analysis Set||mmHg||Inter-Quartile Range|Median
667690|NCT01736475|Secondary|Change in Vital Signs From Screening - Respiratory Rate||Screening, week 2, week 4, exposure day 10-15, month 3, study completion/termination|Safety Analysis Set||breaths per minute||Inter-Quartile Range|Median
667691|NCT01736475|Secondary|Change in Vital Signs From Screening - Pulse Rate||Screening, week 2, week 4, exposure day 10-15, month 3, study completion/termination|Safety Analysis Set||beats per minute||Inter-Quartile Range|Median
667692|NCT01736475|Secondary|Change in Vital Signs From Screening - Temperature||Screening, week 2, week 4, exposure day 10-15, month 3, study completion/termination|Safety Analysis Set||Celsius||Inter-Quartile Range|Median
667693|NCT01736475|Secondary|Pharmacokinetics (Pk) -Time to Maximum Concentration in Plasma (Tmax) (One-stage Clotting Assay)|Tmax in hours will be defined as the time to reach Cmax. Participants in the pharmacokinetic full analysis set (PKFAS) analysis set received an initial infusion of ADVATE for pharmacokinetic analysis (PK-1) followed by a washout period and an infusion of BAX 855 for a second pharmacokinetic analysis (PK-2). After at least 50 EDs of BAX 855, participants in the PK subgroup received another infusion of BAX 855 for pharmacokinetic analysis (PK-3).|Within 30 minutes prior to start of infusion; and post-infusion at 10, 30 minutes, and 1, 3, 6, 9, 24, 32, 48, 56, 72 (PK2 and PK3 only), and 96 hours (PK2 and PK3 only).|Pharmacokinetic full analysis set (PKFAS)||hours||Standard Deviation|Mean
667694|NCT01736475|Secondary|Pharmacokinetics (Pk) - Maximum Plasma Concentration (Cmax) (One-stage Clotting Assay)|Participants in the pharmacokinetic full analysis set (PKFAS) analysis set received an initial infusion of ADVATE for pharmacokinetic analysis (PK-1) followed by a washout period and an infusion of BAX 855 for a second pharmacokinetic analysis (PK-2). After at least 50 EDs of BAX 855, participants in the PK subgroup received another infusion of BAX 855 for pharmacokinetic analysis (PK-3).|Within 30 minutes prior to start of infusion; and post-infusion at 10, 30 minutes, and 1, 3, 6, 9, 24, 32, 48, 56, 72 (PK2 and PK3 only), and 96 hours (PK2 and PK3 only).|Pharmacokinetic full analysis set (PKFAS)||IU/dL||Standard Deviation|Mean
667695|NCT01736475|Secondary|Pharmacokinetics (Pk) - Apparent Volume of Distribution at Steady State (Vss) (One-stage Clotting Assay)|"The apparent volume of distribution at steady state (Vss) will be calculated as: Vss = Clearance * Mean Residence Time.
Participants in the pharmacokinetic full analysis set (PKFAS) analysis set received an initial infusion of ADVATE for pharmacokinetic analysis (PK-1) followed by a washout period and an infusion of BAX 855 for a second pharmacokinetic analysis (PK-2). After at least 50 EDs of BAX 855, participants in the PK subgroup received another infusion of BAX 855 for pharmacokinetic analysis (PK-3)."|Within 30 minutes prior to start of infusion; and post-infusion at 10, 30 minutes, and 1, 3, 6, 9, 24, 32, 48, 56, 72 (PK2 and PK3 only), and 96 hours (PK2 and PK3 only).|Pharmacokinetic full analysis set (PKFAS)||dL/kg||Standard Deviation|Mean
667696|NCT01736475|Secondary|Pharmacokinetics (Pk) - Area Under the Concentration Versus Time Curve From 0 to Infinity (AUC0-∞) (One-stage Clotting Assay)|"Calculated by WinNonlin NCA (Model 201, calculation method: Linear Trapezoidal Linear/Log Interpolation).
Participants in the pharmacokinetic full analysis set (PKFAS) analysis set received an initial infusion of ADVATE for pharmacokinetic analysis (PK-1) followed by a washout period and an infusion of BAX 855 for a second pharmacokinetic analysis (PK-2). After at least 50 EDs of BAX 855, participants in the PK subgroup received another infusion of BAX 855 for pharmacokinetic analysis (PK-3)."|Within 30 minutes prior to start of infusion; and post-infusion at 10, 30 minutes, and 1, 3, 6, 9, 24, 32, 48, 56, 72 (PK2 and PK3 only), and 96 hours (PK2 and PK3 only).|Pharmacokinetic full analysis set (PKFAS)||(IU*hours)/dL||Standard Deviation|Mean
667697|NCT01736475|Secondary|Pharmacokinetics (Pk) - Incremental Recovery Over Time (One-stage Clotting Assay)|"Incremental recovery (IR) in (IU/dL)/ (IU/kg) calculated as: IR = (Cmax– (C pre-infusion)) / (Dose/kg), where C =concentration.
Participants in the pharmacokinetic full analysis set (PKFAS) analysis set received an initial infusion of ADVATE for pharmacokinetic analysis (PK-1) followed by a washout period and an infusion of BAX 855 for a second pharmacokinetic analysis (PK-2). After at least 50 EDs of BAX 855, participants in the PK subgroup received another infusion of BAX 855 for pharmacokinetic analysis (PK-3)."|Within 30 minutes prior to start of infusion; and post-infusion at 10, 30 minutes, and 1, 3, 6, 9, 24, 32, 48, 56, 72 (PK2 and PK3 only), and 96 hours (PK2 and PK3 only).|Pharmacokinetic full analysis set (PKFAS)||(IU/dL)/(IU/kg)||Standard Deviation|Mean
667698|NCT01736475|Secondary|Pharmacokinetics (Pk) - Total Body Clearance (One-stage Clotting Assay)|"Clearance in dL/(kg.h) will be calculated as the dose in IU/kg divided by the total area under the curve starting from the begin of infusion (or the end of infusion if start time is not available).
Participants in the pharmacokinetic full analysis set (PKFAS) analysis set received an initial infusion of ADVATE for pharmacokinetic analysis (PK-1) followed by a washout period and an infusion of BAX 855 for a second pharmacokinetic analysis (PK-2). After at least 50 EDs of BAX 855, participants in the PK subgroup received another infusion of BAX 855 for pharmacokinetic analysis (PK-3)."|Within 30 minutes prior to start of infusion; and post-infusion at 10, 30 minutes, and 1, 3, 6, 9, 24, 32, 48, 56, 72 (PK2 and PK3 only), and 96 hours (PK2 and PK3 only).|Pharmacokinetic full analysis set (PKFAS)||dL/(kg*hours)||Standard Deviation|Mean
667950|NCT01732835|Secondary|LVID Diastole - Change From Baseline|Left ventricular internal dimension. Transthoracic echocardiography parameter.|Baseline and 6 months|Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.||cm||Standard Deviation|Mean
667699|NCT01736475|Secondary|Pharmacokinetics (Pk) - Mean Residence Time (One-stage Clotting Assay)|"The mean residence time (MRT) w as calculated as total area under the moment curve divided by the total area under the curve starting from the begin of infusion (or the end of infusion if start time is not available).
Participants in the pharmacokinetic full analysis set (PKFAS) analysis set received an initial infusion of ADVATE for pharmacokinetic analysis (PK-1) followed by a washout period and an infusion of BAX 855 for a second pharmacokinetic analysis (PK-2). After at least 50 EDs of BAX 855, participants in the PK subgroup received another infusion of BAX 855 for pharmacokinetic analysis (PK-3)."|Within 30 minutes prior to start of infusion; and post-infusion at 10, 30 minutes, and 1, 3, 6, 9, 24, 32, 48, 56, 72 (PK2 and PK3 only), and 96 hours (PK2 and PK3 only).|Pharmacokinetic full analysis set (PKFAS)||hours||Standard Deviation|Mean
667700|NCT01736475|Secondary|Pharmacokinetics (Pk) - Plasma Half-life (One-stage Clotting Assay)|"Terminal half-life calculated as log_e2/λz where λz is the terminal elimination rate constant.
Participants in the pharmacokinetic full analysis set (PKFAS) analysis set received an initial infusion of ADVATE for pharmacokinetic analysis (PK-1) followed by a washout period and an infusion of BAX 855 for a second pharmacokinetic analysis (PK-2). After at least 50 EDs of BAX 855, participants in the PK subgroup received another infusion of BAX 855 for pharmacokinetic analysis (PK-3)."|Within 30 minutes prior to start of infusion; and post-infusion at 10, 30 minutes, and 1, 3, 6, 9, 24, 32, 48, 56, 72 (PK2 and PK3 only), and 96 hours (PK2 and PK3 only).|Pharmacokinetic full analysis set (PKFAS)||hours||Standard Deviation|Mean
667701|NCT01736475|Secondary|Patient Reported Outcomes - Short Form (SF)-36, Change From Baseline to End of Study|Change from Baseline to End of Study for SF-36 Questionnaire is provided. Scores for individual SF-36 categories range from 0 to 100 with higher scores representing better health. Given that higher scores indicate better health-related quality of life (HRQoL) and that the change scores were calculated as the value at study completion minus the value at baseline, a negative change score indicates a worsening of HRQoL.|Baseline; and end of study visit [at least 50 exposure days or 6 months (±2 weeks), whichever occurs last, for the prophylaxis arm and 6 months (± 2 weeks) for the on-demand arm]|Full Analysis Set - Subset of participants with both baseline and study completion SF-36 scores||Score on a scale||Standard Deviation|Mean
667702|NCT01736475|Secondary|Patient Reported Outcomes: Haemo-SYM Questionnaire, Change in Score From Baseline to End of Study|"The HAEMO-SYM has two subscales: pain and bleeds. HAEMO-SYM subscale scores are calculated by taking the mean of the items in each subscale and transforming them to a 0 (none or absent) to 100 (very severe) scale.
Given that higher scores indicate more severe symptoms on the Haemo-SYM and that the change scores were calculated as the value at study completion minus the value at baseline, a negative change score indicates an improvement (reduction in symptoms). Conversely, a positive change score indicates worsening symptoms."|Baseline; and end of study visit [at least 50 exposure days or 6 months (±2 weeks), whichever occurs last, for the prophylaxis arm and 6 months (± 2 weeks) for the on-demand arm].|Full Analysis Set - Subset of participants with both baseline and study completion HAEMO-SYM scores||Score on a scale||Standard Deviation|Mean
667703|NCT01736475|Secondary|Immunogenicity - Number of Participants With Positive Inhibitory Antibodies to FVIII, Binding Antibodies to FVIII, PEG-VIII, PEG and Anti-CHO Antibodies at Study Completion/Termination|"Number of participants who received BAX855, with immunogenicity data from study completion/termination visit.
FVIII = factor VIII; PEG-VIII = polyethylene glycol-factor VIII; Anti-CHO = Anti-Chinese hamster ovary"|From first exposure to BAX 855 until the end of the study, [at least 50 exposure days or 6 months (±2 weeks), whichever occurs last, for the prophylaxis arm; and 6 months (± 2 weeks) for the on-demand arm].|Safety Analysis Set (SAS) - who received BAX855 during the study period. Note: one participant was assigned to the prophylactic arm but did not receive BAX855 (only received ADVATE, during the screening period).||Participants|||Number
667704|NCT01736475|Secondary|Percentage of Participants With Adverse Events|Adverse Events (AEs) and Serious Adverse Events (SAEs)|From first exposure to BAX 855 until the end of the study, [at least 50 exposure days or 6 months (±2 weeks), whichever occurs last, for the prophylaxis arm; and 6 months (± 2 weeks) for the on-demand arm].|Safety Analysis Set (SAS) - All participants treated with BAX 855 were analyzed as a single group (ie on-demand and prophylaxis treatment regimens were analyzed as a single group).||percent of participants|||Number
667705|NCT01736475|Secondary|Weight-adjusted Consumption of BAX 855 - Per Treatment of Bleeding Episode (BE) and Per BE for Maintenance of Hemostasis|Infusions per bleeding episode for maintenance of hemostasis only includes infusions following the resolution of a bleed to maintain hemostasis.|Treatment of Bleeding Episode (BE): Minor/Moderate BE every 12 to 24 hours until bleeding is resolved; Major BE every 8 to 12 hours until bleeding is resolved. Per BE for Maintenance of Hemostasis: within 48 hours after bleeding episode resolution.|"Full Analysis Set (FAS) - Note: data analyzed by subsets of FAS (1) participants who received BAX855 for treatment of BEs (2) BAX855 for Maintenance of Hemostasis.
Subset of participants who received BAX855 for treatment of BEs: N= 92
Subset BAX855 for Maintenance of Hemostasis participants: N=16"||IU/kg|Participants|Standard Deviation|Mean
667706|NCT01736475|Secondary|Weight-adjusted Consumption of BAX 855 - Per Prophylactic Infusion and Pharmacokinetic (PK) Infusion||Prophylactic Infusion: ≥50 exposure days or 6 months (±2 weeks), whichever occurs last. PK Infusion: PK #1 Pre-infusion within 30 minutes; Post-infusion 10 min, and 0.5, 1, 3, 6, 24, 32, 48, 56 hours (h). PK #2 also at Post-infusion 96h|"Full Analysis Set (FAS) - Note: data analyzed by subsets of FAS (1) participants who received BAX855 prophylactic infusion or (2) BAX855 pharmacokinetic (PK) participants.
Subset of participants who received BAX855 prophylactic infusion: N= 120
Subset of BAX855 pharmacokinetic (PK) participants: N=26"||IU/kg|Participants|Standard Deviation|Mean
667707|NCT01736475|Secondary|Number of Participants With ≤1, 2, 3, 4, 5, 6, or >6 Month Time Intervals Between Bleeding Episodes or no Bleeding Episodes|Interval between Bleeds in months was calculated as: Observation period for efficacy (in days)/(number of bleeds)*(12/365.2425)|From first exposure to BAX 855 until the end of the study, [at least 50 exposure days or 6 months (±2 weeks), whichever occurs last, for the prophylaxis arm; and 6 months (± 2 weeks) for the on-demand arm].|Study participants from the Full Analysis Set (FAS) who received BAX855 during the study period. Note: one participant was assigned to the prophylactic arm (thus was included in the FAS) and received only ADVATE during the screening period.||Participants|||Number
667951|NCT01732835|Secondary|LV Mass - Change From Baseline|Left ventricular mass. Transthoracic echocardiography parameter.|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.||g||Standard Deviation|Mean
667708|NCT01736475|Secondary|Average Number of BAX 855 Infusions Needed for the Treatment of Bleeding Episodes||From first exposure to BAX 855 until the end of the study, [at least 50 exposure days or 6 months (±2 weeks), whichever occurs last, for the prophylaxis arm; and 6 months (± 2 weeks) for the on-demand arm].|Participants from the Full Analysis Set who experienced at least one bleeding episode.||Infusions||Standard Deviation|Mean
667709|NCT01736475|Secondary|Rate of Success of BAX 855 for Treatment of Bleeding Episodes|Success in the control of bleeding was defined as a rating of excellent or good using the Efficacy Rating Scale for Treatment of Bleeding Episodes measured 24 hours after initiation of treatment for the bleeding episode. EXCELLENT: Full relief of pain and cessation of objective signs of bleeding (eg, swelling, tenderness, and decreased range of motion in the case of musculoskeletal hemorrhage) after a single infusion. No additional infusion is required for the control of bleeding. Administration of further infusions to maintain hemostasis would not affect this scoring. GOOD: Definite pain relief and/or improvement in signs of bleeding after a single infusion. Possibly requires more than 1 infusion for complete resolution. FAIR: Probable and/or slight relief of pain and slight improvement in signs of bleeding after a single infusion. Required more than 1 infusion for complete resolution. NONE: No improvement or condition worsens.|At least 50 exposure days or 6 months (±2 weeks), whichever occurs last, for the prophylaxis arm and 6 months (± 2 weeks) for the on-demand arm.|Full Analysis Set - All bleeding episodes treated with BAX 855 in participants on on-demand and prophylaxis treatment regimens were analyzed as a single group.||Bleeding episodes|Participants|95% Confidence Interval|Number
667710|NCT01736475|Primary|Annualized Bleeding Rate (ABR)|Comparisons between prophylactic and on-demand treatment were based on ABR estimates from a negative binomial regression model, taking into account the treatment regimen, target joints and age at screening, and duration of the observation period for efficacy.|9 months|Full Analysis Set||Bleeds per year||95% Confidence Interval|Least Squares Mean
667711|NCT01736215|Secondary|Transferring Iron Binding Capacity (TIBC)|TIBC is a medical laboratory test that measures the blood's capacity to bind iron with transferrin.|Baseline, Week 1 and Week 2|Participants who received erythropoietin treatment and had the data available at least on Baseline and at all measurable time points of study evaluation period. Here, 'n' signifies participants who were evaluated for this outcome measure at given time point.||Mcg per dl||Standard Deviation|Mean
667712|NCT01736215|Secondary|Serum Iron Level|Serum iron is a test that measures the amount of iron in the blood which is bound to transferrin.|Baseline, Week 1 and Week 2|Participants who received erythropoietin treatment and had the data available at least on Baseline and at all measurable time points of study evaluation period. Here, 'N' signifies participants who were evaluated for this outcome measure.||Microgram per deciliter (Mcg per dl)||Standard Deviation|Mean
667713|NCT01736215|Secondary|Serum Ferritin Level|Serum ferritin is the amount of ferritin in a participant's blood. Ferritin is a protein that stores iron and allows the body to use iron.|Baseline, Week 1 and Week 2|Participants who received erythropoietin treatment and had the data available at least on Baseline and at all measurable time points of study evaluation period. Here, 'n' signifies participants who were evaluated for this outcome measure at given time point.||Microgram per liter||Standard Deviation|Mean
667714|NCT01736215|Secondary|Reticulocyte Count|Reticulocytes are immature red blood cells.|Baseline, Week 1, Week 2, Week 4 and Week 8|Participants who received erythropoietin treatment and had the data available at least on Baseline and at all measurable time points of study evaluation period. Here, 'N' signifies participants who were evaluablated for this outcome measure and 'n' signifies participants who were evaluated for this outcome measure at given time point.||Nanogram per liter||Standard Deviation|Mean
667715|NCT01736215|Secondary|Serum Hematocrit Level|Hematocrit is the amount of red blood cells in the blood.|Baseline, Week 1, Week 2, Week 4 and Week 8|Participants who received erythropoietin treatment and had the data available at least on Baseline and at all measurable time points of study evaluation period. Here, 'n' signifies participants who were evaluated for this outcome measure at given time point.||Percentage of red blood cells||Standard Deviation|Mean
667716|NCT01736215|Secondary|Serum Hemoglobin Level|Hemoglobin is defined as a substance that carries oxygen and gives blood its red color.|Baseline, Week 1, Week 2, Week 4 and Week 8|Participants who received erythropoietin treatment and had the data available at least on Baseline and at all measurable time points of study evaluation period. Here, 'n' signifies participants who were evaluated for this outcome measure at given time point.||Gram per deciliter (g per dl)||Standard Deviation|Mean
667717|NCT01736215|Secondary|Number of Participants With C-Reactive Protein (CRP) Level Less Than or Equal to 10.3 or Greater Than 10.4|CRP is a acute serum protein released from liver. It is associated with low hemoglobin or erythropoeitin resistance. Number of participants with CRP level less than or equal to 10.3 or greater than 10.4 were observed.|Baseline|Participants who received erythropoietin treatment and who had sufficient data to perform statistical evaluation were analyzed.||Participants|||Number
667718|NCT01736215|Secondary|Number of Participants With Serum Erythropoietin (EPO) Level (EPO Less Than or Equal to 45.2 or EPO Greater Than 45.3)|EPO is a hormone secreted by kidney that helps in formation of red blood cells in bone marrow. Number of participants with EPO level less than or equal to 45.2 or greater than 45.3 were observed.|Baseline|Participants who received erythropoietin treatment and who had sufficient data to perform statistical evaluation were analyzed.||Participants|||Number
667719|NCT01736215|Primary|Percentage of Participants With Response to Erythropoietin Treatment|Responders of erythropoietin treatment were defined as participants who achieved at least 1 gram per deciliter (g per dl) rise from Baseline in hemoglobin level during within 4-8 weeks or participants who achieved 12 g per dl hemoglobin level at anytime during the study evaluation period (about 8 weeks of follow-up, hemoglobin level reached to 12 g per dl or participants who received blood transfusion at any time of study period) based on National Comprehensive Cancer Institute (NCCN) V3.2009 practice guideline criteria.|8 weeks|Participants who received erythropoietin treatment and had the data available at least on Baseline and at the end of study evaluation period.||Percentage of participants|||Number
667781|NCT01735617|Secondary|The Percentage of Patients With 17-OHP and Androstenedione Levels at 0700h Within Proposed Optimal Ranges Whilst on Chronocort and Whilst on Standard Therapy (at Baseline)|Proposed optimal ranges of 17-OHP: 300-1200ng/dl Proposed optimal ranges of androstenedione: 40-150ng.dl for males and 30-200ng/dl for females|Specific time point (0700hrs)|||percentage of participants|||Number
667720|NCT01736176|Secondary|Change From Baseline in Controlled Oral Word Association Test (COWAT) Verbal Fluency Scores at Week 60|"Letter fluency was assessed using a paper and pen test, in which participants were asked to generate as many words as possible in 60 seconds, starting with the letters F, A, or S.
The COWAT All Letters score is the number of words recalled in all post-baseline assessments, regardless of letter used.
The COWAT Baseline Letter score is the number of words recalled in post-baseline assessments that used the same letter as at Baseline."|Baseline and Week 60|Efficacy dataset with available data||words||Standard Deviation|Mean
667721|NCT01736176|Secondary|Change From Baseline in CANTAB Spatial Working Memory Strategy Score at Week 12|CANTAB is a computer-based test of the participant's ability to retain spatial information and to manipulate remembered items in working memory. The Spatial Working Memory module requires that subjects find a blue token in a series of displayed boxes and use these to fill up an empty column, while not returning to boxes where a blue token has been previously found. The Strategy score represents the number of times a participant begins a search with the same box for 6- and 8-box problems. Minimum score is 8 and maximum score is 56. Higher numbers indicate poorer performance.|Baseline and Week 12|Efficacy dataset with available data||units on a scale||Standard Deviation|Mean
667722|NCT01736176|Secondary|Change From Baseline in Cambridge Neuropsychological Test Automated Battery (CANTAB) Spatial Working Memory Between Errors Score at Week 12|CANTAB is a computer-based test of the participant's ability to retain spatial information and to manipulate remembered items in working memory. The Spatial Working Memory module requires that subjects find a blue token in a series of displayed boxes and use these to fill up an empty column, while not returning to boxes where a blue token has been previously found. The between errors score is the number of times the participant revisited a box in which a token was previously found; errors are calculated for 4-, 6-, and 8-box trials. Higher numbers indicate poorer performance.|Baseline and Week 12|Efficacy dataset with available data||errors||Standard Deviation|Mean
667723|NCT01736176|Secondary|Change From Baseline in Health-related Productivity|"The Health-Related Productivity Questionnaire (HRPQ) is a generic measure of the impact of disease on the ability of the participant to be productive at paid employment or at performance of household chores. Questions inquire about the amount of time they were scheduled/planned to work, the number of the scheduled/planned hours they were able to work and their ability to be productive for the hours of work they did perform.
Absenteeism: Number of hours not worked due to PD or it's treatments;
Presenteeism: Number of hours of lost productivity while at work due to PD or it's treatments;
Total hours lost: Number of hours lost due to absenteeism and presenteeism"|Baseline, Week 12 and Week 60|Efficacy dataset with available data. Workplace hours lost is calculated for participants who were employed.||hours||Standard Deviation|Mean
667724|NCT01736176|Secondary|Treatment Satisfaction Questionnaire Scores|The Treatment Satisfaction Questionnaire (TSQ) is a single item instrument developed by the Sponsor on which the participant indicated their level of satisfaction or dissatisfaction with their PD treatment. The responses are recorded on a Likert-type scale (Very Satisfied, Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Dissatisfied, Very Dissatisfied).|Week 12 and Week 60|Efficacy dataset||Participants|||Count of Participants
667725|NCT01736176|Secondary|Percentage of Participants With a Patient Global Impression of Change (PGIC) Response of Improved|"The PGIC is a 7-point response scale. Participants were asked to rate their change in status using the following 7-point scale:
1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6 = Much worse, 7 = Very much worse.
The responses of Very much improved, Much improved and Minimally improved on the PGIC were used to define responders."|Week 12 and Week 60|Efficacy dataset||percentage of participants|||Number
667726|NCT01736176|Secondary|Change From Baseline in PDQ-39 Bodily Discomfort Domain Score|"The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing eight domains of health (mobility [10 items], activities of daily living [six items], emotional wellbeing [six items], stigma [four items], communication [three items] and bodily discomfort [three items]) which subjects consider to be adversely affected by the disease. Each item is scored on the following 5-point scale: 0 = Never, 1 = Occasionally, 2 = Sometimes, 3 = Often, 4 = Always (or cannot do at all, if applicable).
Domain scores are calculated by summing the answers to the questions in the domain, dividing by the highest score possible and then multiplying by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status and higher scores are associated with the more severe symptoms of the disease such as tremors and stiffness."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point||units on a scale||Standard Error|Least Squares Mean
667727|NCT01736176|Secondary|Change From Baseline in PDQ-39 Communication Domain Score|"The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing eight domains of health (mobility [10 items], activities of daily living [six items], emotional wellbeing [six items], stigma [four items], communication [three items] and bodily discomfort [three items]) which subjects consider to be adversely affected by the disease. Each item is scored on the following 5-point scale: 0 = Never, 1 = Occasionally, 2 = Sometimes, 3 = Often, 4 = Always (or cannot do at all, if applicable).
Domain scores are calculated by summing the answers to the questions in the domain, dividing by the highest score possible and then multiplying by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status and higher scores are associated with the more severe symptoms of the disease such as tremors and stiffness."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point||units on a scale||Standard Error|Least Squares Mean
667728|NCT01736176|Secondary|Change From Baseline in PDQ-39 Cognition Domain Score|"The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing eight domains of health (mobility [10 items], activities of daily living [six items], emotional wellbeing [six items], stigma [four items], communication [three items] and bodily discomfort [three items]) which subjects consider to be adversely affected by the disease. Each item is scored on the following 5-point scale: 0 = Never, 1 = Occasionally, 2 = Sometimes, 3 = Often, 4 = Always (or cannot do at all, if applicable).
Domain scores are calculated by summing the answers to the questions in the domain, dividing by the highest score possible and then multiplying by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status and higher scores are associated with the more severe symptoms of the disease such as tremors and stiffness."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point||units on a scale||Standard Error|Least Squares Mean
667729|NCT01736176|Secondary|Change From Baseline in PDQ-39 Social Support Domain Score|"The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing eight domains of health (mobility [10 items], activities of daily living [six items], emotional wellbeing [six items], stigma [four items], communication [three items] and bodily discomfort [three items]) which subjects consider to be adversely affected by the disease. Each item is scored on the following 5-point scale: 0 = Never, 1 = Occasionally, 2 = Sometimes, 3 = Often, 4 = Always (or cannot do at all, if applicable).
Domain scores are calculated by summing the answers to the questions in the domain, dividing by the highest score possible and then multiplying by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status and higher scores are associated with the more severe symptoms of the disease such as tremors and stiffness."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point||units on a scale||Standard Error|Least Squares Mean
667730|NCT01736176|Secondary|Change From Baseline in PDQ-39 Stigma Domain Score|"The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing eight domains of health (mobility [10 items], activities of daily living [six items], emotional wellbeing [six items], stigma [four items], communication [three items] and bodily discomfort [three items]) which subjects consider to be adversely affected by the disease. Each item is scored on the following 5-point scale: 0 = Never, 1 = Occasionally, 2 = Sometimes, 3 = Often, 4 = Always (or cannot do at all, if applicable).
Domain scores are calculated by summing the answers to the questions in the domain, dividing by the highest score possible and then multiplying by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status and higher scores are associated with the more severe symptoms of the disease such as tremors and stiffness."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point||units on a scale||Standard Error|Least Squares Mean
667731|NCT01736176|Secondary|Change From Baseline in PDQ-39 Emotional Well-Being Domain Score|"The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing eight domains of health (mobility [10 items], activities of daily living [six items], emotional wellbeing [six items], stigma [four items], communication [three items] and bodily discomfort [three items]) which subjects consider to be adversely affected by the disease. Each item is scored on the following 5-point scale: 0 = Never, 1 = Occasionally, 2 = Sometimes, 3 = Often, 4 = Always (or cannot do at all, if applicable).
Domain scores are calculated by summing the answers to the questions in the domain, dividing by the highest score possible and then multiplying by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status and higher scores are associated with the more severe symptoms of the disease such as tremors and stiffness."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point||units on a scale||Standard Error|Least Squares Mean
667732|NCT01736176|Secondary|Change From Baseline in PDQ-39 Activities of Daily Living Domain Score|"The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing eight domains of health (mobility [10 items], activities of daily living [six items], emotional wellbeing [six items], stigma [four items], communication [three items] and bodily discomfort [three items]) which subjects consider to be adversely affected by the disease. Each item is scored on the following 5-point scale: 0 = Never, 1 = Occasionally, 2 = Sometimes, 3 = Often, 4 = Always (or cannot do at all, if applicable).
Domain scores are calculated by summing the answers to the questions in the domain, dividing by the highest score possible and then multiplying by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status and higher scores are associated with the more severe symptoms of the disease such as tremors and stiffness."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point||units on a scale||Standard Error|Least Squares Mean
667733|NCT01736176|Secondary|Change From Baseline in PDQ-39 Mobility Domain Score|"The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing eight domains of health (mobility [10 items], activities of daily living [six items], emotional wellbeing [six items], stigma [four items], communication [three items] and bodily discomfort [three items]) which subjects consider to be adversely affected by the disease. Each item is scored on the following 5-point scale: 0 = Never, 1 = Occasionally, 2 = Sometimes, 3 = Often, 4 = Always (or cannot do at all, if applicable).
Domain scores are calculated by summing the answers to the questions in the domain, dividing by the highest score possible and then multiplying by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status and higher scores are associated with the more severe symptoms of the disease such as tremors and stiffness."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point||units on a scale||Standard Error|Least Squares Mean
667734|NCT01736176|Secondary|Change From Baseline in Parkinson's Disease Questionnaire-39 Item (PDQ-39) Summary Index|"The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing eight domains of health (mobility [10 items], activities of daily living [six items], emotional wellbeing [six items], stigma [four items], communication [three items] and bodily discomfort [three items]) which subjects consider to be adversely affected by the disease. Each item is scored on the following 5-point scale: 0 = Never, 1 = Occasionally, 2 = Sometimes, 3 = Often, 4 = Always (or cannot do at all, if applicable).
The PDQ-39 Summary Index (PDQ-SI) is the sum of all answers divided by the highest score possible (i.e., number of answers multiplied by 4) which is multiplied by 100 to put the score on a 0 – 100 scale where lower scores indicate a better perceived health status and higher scores are associated with the more severe symptoms of the disease such as tremors and stiffness."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point||units on a scale||Standard Error|Least Squares Mean
667735|NCT01736176|Secondary|Change From Baseline in UPDRS Part V: Modified Hoehn and Yahr Staging Score|"The UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The UPDRS assessment was performed by an approved, trained rater.
The UPDRS was made up of the following sections:
Part I – Mentation, Behavior, and Mood
Part II – Activities of Daily Living
Part III – Motor Examination
Part IV – Complications of Therapy (including dyskinesias)
Part V – Modified Hoehn and Yahr Staging
The modified Hoehn and Yahr scale is as follows:
Stage 0: No signs of disease
Stage 1.0: Symptoms are very mild; unilateral involvement only
Stage 1.5: Unilateral and axial involvement
Stage 2: Bilateral involvement without impairment of balance
Stage 2.5: Mild bilateral disease with recovery on pull test
Stage 3: Mild to moderate bilateral disease; some postural instability; physically independent
Stage 4: Severe disability; still able to walk or stand unassisted
Stage 5: Wheelchair bound or bedridden unless aided"|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point||units on a scale||Standard Error|Least Squares Mean
667736|NCT01736176|Secondary|Change From Baseline in UPDRS Dyskinesia Items Score|"The UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The UPDRS assessment was performed by an approved, trained rater.
The UPDRS was made up of the following sections:
Part I – Mentation, Behavior, and Mood
Part II – Activities of Daily Living
Part III – Motor Examination
Part IV – Complications of Therapy (including dyskinesias)
Part V – Modified Hoehn and Yahr Staging
The dyskinesia items score includes questions 32, 33 and 34 from the complications of therapy section of the UPDRS which address dyskinesia duration, disability, and pain. Each question was answered on a scale from 0 (Normal) to 4 (Severe); the UPDRS dyskinesia items score was computed as the sum of these items and ranged from 0 (not affected) to 12 (most severely affected)."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point||units on a scale||Standard Error|Least Squares Mean
667737|NCT01736176|Secondary|Change From Baseline in UPDRS Part IV: Complications of Therapy Score|"The UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The UPDRS assessment was performed by an approved, trained rater.
The UPDRS was made up of the following sections:
Part I – Mentation, Behavior, and Mood
Part II – Activities of Daily Living
Part III – Motor Examination
Part IV – Complications of Therapy (including dyskinesias)
Part V – Modified Hoehn and Yahr Staging
The complications of therapy section includes 11 items addressing dyskinesia duration, disability, and pain, early morning dystonia, “offs”-predictable, “offs”-unpredictable, “offs”-sudden, “offs”-duration, anorexia-nausea-vomiting, sleep disturbance, and symptomatic orthostasis. Four questions are answered on a scale from 0 (Normal) to 4 (Severe) and seven on a binary scale where 0=No and 1=Yes. The UPDRS Part IV: complications of therapy score was computed as the sum of these items and ranged from 0 (not affected) to 23 (most severely affected)."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point||units on a scale||Standard Error|Least Squares Mean
667738|NCT01736176|Secondary|Change From Baseline in UPDRS Part III: Motor Examination Score|"The UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The UPDRS assessment was performed by an approved, trained rater.
The UPDRS was made up of the following sections:
Part I – Mentation, Behavior, and Mood
Part II – Activities of Daily Living
Part III – Motor Examination
Part IV – Complications of Therapy (including dyskinesias)
Part V – Modified Hoehn and Yahr Staging
The motor examination score includes 17 items addressing speech, facial expression, tremor at rest, action tremor, rigidity, finger taps, hand movements, hand pronation and supination, leg agility, arising from chair, posture, gait, postural stability, and body bradykinesia. Each question is answered on a scale from 0 (Normal) to 4 (Severe), some items include multiple grades for each extremity. The UPDRS Part III: motor examination score was computed as the sum of these items and ranged from 0 (not affected) to 108 (most severely affected)."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at baseline (37) and at each time point||units on a scale||Standard Error|Least Squares Mean
667739|NCT01736176|Secondary|Change From Baseline in UPDRS Part II: Activities of Daily Living (ADL) Score|"The Unified Parkinson's Disease Rating Scale (UPDRS) is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The UPDRS assessment was performed by an approved, trained rater.
The UPDRS was made up of the following sections:
Part I – Mentation, Behavior, and Mood
Part II – Activities of Daily Living
Part III – Motor Examination
Part IV – Complications of Therapy (including dyskinesias)
Part V – Modified Hoehn and Yahr Staging
The activities of daily living score includes 13 items addressing speech, salivation, swallowing, handwriting, cutting food, dressing, hygiene, turning in bed, falling, freezing, walking, tremor, and sensory complaints. Each question is answered on a scale from 0 (Normal) to 4 (Severe). The UPDRS Part II: activities of daily living score was computed as the sum of these items and ranged from 0 (not affected) to 52 (most severely affected)."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at baseline (37) and at each time point||units on a scale||Standard Error|Least Squares Mean
667740|NCT01736176|Secondary|Change From Baseline in UPDRS Part I: Mentation, Behavior, and Mood Score|"The Unified Parkinson's Disease Rating Scale (UPDRS) is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The UPDRS assessment was performed by an approved, trained rater.
The UPDRS was made up of the following sections:
Part I – Mentation, Behavior, and Mood
Part II – Activities of Daily Living
Part III – Motor Examination
Part IV – Complications of Therapy (including dyskinesias)
Part V – Modified Hoehn and Yahr Staging
The mentation, behavior, and mood score includes 4 items addressing intellectual impairment, thought disorder, motivation/initiative, and depression. Each question is answered on a scale from 0 (None) to 4 (Severe). The UPDRS Part I: mentation, behavior, and mood score was computed as the sum of these items and ranged from 0 (not affected) to 16 (most severely affected)."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at baseline (37) and each time point||units on a scale||Standard Error|Least Squares Mean
667741|NCT01736176|Secondary|Change From Baseline for Unified Parkinson's Disease Rating Scale (UPDRS) Total Score|"The Unified Parkinson's Disease Rating Scale (UPDRS) is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The UPDRS assessment was performed by an approved, trained rater.
The UPDRS was made up of the following sections:
Part I – Mentation, Behavior, and Mood
Part II – Activities of Daily Living
Part III – Motor Examination
Part IV – Complications of Therapy (including dyskinesias)
Part V – Modified Hoehn and Yahr Staging
The Total UPDRS score includes 31 items contributing to three subscales: (I) Mentation, Behavior, and Mood; (II) Activities of Daily Living; and (III) Motor Examination. Each question is answered on a scale from 0 (None) to 4 (Severe); Some questions require multiple grades assigned to each extremity. The UPDRS Total score was computed as the sum of these 3 UPDRS subscales and ranged from 0 to 176, with 176 representing the worst (total) disability, and 0 no disability."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at baseline (37) and each time point||units on a scale||Standard Error|Least Squares Mean
667782|NCT01735617|Primary|Pharmacokinetic Profile (Tmax) Following Short-term Treatment With Chronocort® in Adult Patients With Congenital Adrenal Hyperplasia|Time to maximum plasma concentration (tmax)|24 hours|All treated subjects||Hours||Standard Deviation|Mean
667783|NCT01735617|Primary|Pharmacokinetic Profile (AUC0-24) Following Short-term Treatment With Chronocort® in Adult Patients With Congenital Adrenal Hyperplasia|Area under the curve (AUC) from 0 to 24 hours (sampling occurs at the following timepoints: 2300, 0100, 0300, 0500, 0600, 0700, 0800, 0900, 1000, 1100, 1200, 1300, 1400, 1500, 1600, 1700, 1900, 2100, 2300hrs)|24 hours (at 2300, 0100, 0300, 0500, 0600, 0700, 0800, 0900, 1000, 1100, 1200, 1300, 1400, 1500, 1600, 1700, 1900, 2100, 2300hrs)|All treated subjects||h*nmol/L||Standard Deviation|Mean
667742|NCT01736176|Secondary|"Change From Baseline in Mean Daily Normalized On Time Without Troublesome Dyskinesia Based on PD Diary"|"The PD Diary was completed by the participant for 3 consecutive days prior to each visit. Participants recorded whether they had been On, Off, or Asleep and the severity of their dyskinesias (troublesome or not troublesome) for each 30-minute period during their normal waking time and upon awakening from sleep.
On was defined as time when medication was providing benefit with regard to mobility, slowness, and stiffness. On time without troublesome dyskinesia is a composite of On time without dyskinesia (involuntary twisting, turning movements which are an effect of medication) plus On time with non-troublesome dyskinesia (dyskinesia that does not interfere with function or cause meaningful discomfort).
PD Diary times were normalized to a 16-hour waking time to account for variation in participants' sleep time. Normalized PD Diary times at a given visit were calculated as the average normalized time from the PD Diary for the 3 days prior to the visit."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point||hours||Standard Error|Least Squares Mean
667743|NCT01736176|Secondary|"Change From Baseline in Mean Daily Normalized Off Time Based on Parkinson's Disease Diary"|"The Parkinson's Disease Diary was completed by the participant for 3 consecutive days prior to each visit for the full 24 hours of each day. Participants recorded whether they had been On, Off, or Asleep and the severity of their dyskinesias (troublesome or not troublesome) for each 30-minute period during their normal waking time and upon awakening from time asleep.
Off time was defined as time when medication has worn off and was no longer providing benefit with regard to mobility, slowness, and stiffness.
Parkinson's Disease Diary times were normalized to a 16-hour waking time to account for variation in participants' sleep time. Normalized PD Diary times at a given visit were calculated as the average normalized time from the PD Diary for the 3 days prior to the visit."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point||hours||Standard Error|Least Squares Mean
667744|NCT01736176|Secondary|Change From Baseline in NMSS Miscellaneous Domain Score|"The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastro-intestinal tract, urinary, sexual function, and miscellaneous (pain, taste/smell, weight change, excessive sweating). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent).
Item scores are calculated as the product of severity and frequency; domain scores are obtained by summing the item scores. The NMSS miscellaneous domain score ranges from 0 to 48 with a lower score indicating fewer symptoms; a negative change from baseline indicates improvement in symptoms."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point||units on a scale||Standard Error|Least Squares Mean
667745|NCT01736176|Secondary|Change From Baseline in NMSS Sexual Function Domain Score|"The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastro-intestinal tract, urinary, sexual function, and miscellaneous (pain, taste/smell, weight change, excessive sweating). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent).
Item scores are calculated as the product of severity and frequency; domain scores are obtained by summing the item scores. The NMSS sexual function domain score ranges from 0 to 24 with a lower score indicating fewer symptoms; a negative change from baseline indicates improvement in symptoms."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point||units on a scale||Standard Error|Least Squares Mean
667746|NCT01736176|Secondary|Change From Baseline in NMSS Urinary Domain Score|"The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastro-intestinal tract, urinary, sexual function, and miscellaneous (pain, taste/smell, weight change, excessive sweating). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent).
Item scores are calculated as the product of severity and frequency; domain scores are obtained by summing the item scores. The NMSS urinary domain score ranges from 0 to 36 with a lower score indicating fewer symptoms; a negative change from baseline indicates improvement in symptoms."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point||units on a scale||Standard Error|Least Squares Mean
667747|NCT01736176|Secondary|Change From Baseline in NMSS Gastrointestinal Tract Domain Score|"The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastro-intestinal tract, urinary, sexual function, and miscellaneous (pain, taste/smell, weight change, excessive sweating). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent).
Item scores are calculated as the product of severity and frequency; domain scores are obtained by summing the item scores. The NMSS gastrointestinal tract domain score ranges from 0 to 36 with a lower score indicating fewer symptoms; a negative change from baseline indicates improvement in symptoms."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point||units on a scale||Standard Error|Least Squares Mean
667748|NCT01736176|Secondary|Change From Baseline in NMSS Attention/Memory Domain Score|"The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastro-intestinal tract, urinary, sexual function, and miscellaneous (pain, taste/smell, weight change, excessive sweating). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent).
Item scores are calculated as the product of severity and frequency; domain scores are obtained by summing the item scores. The NMSS attention/memory domain score ranges from 0 to 36 with a lower score indicating fewer symptoms; a negative change from baseline indicates improvement in symptoms."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point||units on a scale||Standard Error|Least Squares Mean
667784|NCT01735617|Primary|Pharmacokinetic Profile (Cmax) Following Short-term Treatment With Chronocort® in Adult Patients With Congenital Adrenal Hyperplasia|The maximum plasma concentration (Cmax) of chronocort|24 hours|All treated subjects||nmol/L||Standard Deviation|Mean
667785|NCT01735396|Secondary|Testosterone|Post-treatment changes in testosterone|up to 12 weeks|data not collected|||||
667749|NCT01736176|Secondary|Change From Baseline in NMSS Perceptual Problems/Hallucinations Domain Score|"The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastro-intestinal tract, urinary, sexual function, and miscellaneous (pain, taste/smell, weight change, excessive sweating). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent).
Item scores are calculated as the product of severity and frequency; domain scores are obtained by summing the item scores. The NMSS perceptual problems/hallucinations domain score ranges from 0 to 36 with a lower score indicating fewer symptoms; a negative change from baseline indicates improvement in symptoms."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point||units on a scale||Standard Error|Least Squares Mean
667750|NCT01736176|Secondary|Change From Baseline in NMSS Mood/Cognition Domain Score|"The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastro-intestinal tract, urinary, sexual function, and miscellaneous (pain, taste/smell, weight change, excessive sweating). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent).
Item scores are calculated as the product of severity and frequency; domain scores are obtained by summing the item scores. The NMSS mood/cognition domain score ranges from 0 to 72 with a lower score indicating fewer symptoms; a negative change from baseline indicates improvement in symptoms."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point||units on a scale||Standard Error|Least Squares Mean
667751|NCT01736176|Secondary|Change From Baseline in NMSS Sleep/Fatigue Domain Score|"The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastro-intestinal tract, urinary, sexual function, and miscellaneous (pain, taste/smell, weight change, excessive sweating). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent).
Item scores are calculated as the product of severity and frequency; domain scores are obtained by summing the item scores. The NMSS sleep/fatigue domain score ranges from 0 to 48 with a lower score indicating fewer symptoms; a negative change from baseline indicates improvement in symptoms."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point||units on a scale||Standard Error|Least Squares Mean
667752|NCT01736176|Secondary|Change From Baseline in NMSS Cardiovascular Domain Score|"The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastro-intestinal tract, urinary, sexual function, and miscellaneous (pain, taste/smell, weight change, excessive sweating). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent).
Item scores are calculated as the product of severity and frequency; domain scores are obtained by summing the item scores. The NMSS cardiovascular including falls domain score ranges from 0 to 24 with a lower score indicating fewer symptoms; a negative change from baseline indicates improvement in symptoms."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time points||units on a scale||Standard Error|Least Squares Mean
667753|NCT01736176|Secondary|Change From Baseline to Week 60 in the Non-Motor Symptom Scale (NMSS) Total Score|"The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastro-intestinal tract, urinary, sexual function, and miscellaneous (pain, taste/smell, weight change, excessive sweating). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent).
Item scores are calculated as the product of severity and frequency; the total score is obtained by summing the item scores. The NMSS total score ranges from 0 to 360 with a lower score indicating fewer symptoms; a negative change from baseline indicates improvement in symptoms."|Baseline and Week 60|Efficacy dataset with available data at baseline and week 60||units on a scale||Standard Error|Least Squares Mean
667754|NCT01736176|Secondary|Number of Participants Who Used Healthcare Resources Through Week 60|"Use of healthcare resources was assessed by the investigator using the Health Resource Utilization Questionnaire (HRUQ), a questionnaire developed by the Sponsor regarding the use of healthcare resources due to the participant's Parkinson's disease. The standard version of the questionnaire addressed the following questions over the last 3 months:
Has the subject had a visit to an emergency room?
Has the subject had an outpatient visit to any of the following healthcare providers?
Has the subject been visited in his or her place of residence by a health care professional?
Has the subject received assistance from either of the following for their Parkinson's disease in their home?
Has the subject needed to contact either of the following for immediate assistance related to their Parkinson's disease?
Have family members or friends had to miss any paid work due to the subject's Parkinson's disease?
Has the subject fallen during the past month?"|Week 60|Safety dataset with available data||Participants|||Count of Participants
667755|NCT01736176|Secondary|Number of Participants With Adverse Events|"Adverse events (AEs) related to treatment are those the investigator determined as having a reasonable possibility being related to study drug based on evidence to suggest a causal relationship between the study drug and the adverse event.
A severe AE was defined as an adverse event that caused considerable interference with the participant's usual activities and might be incapacitating or life-threatening.
Serious AEs were defined as those that were life-threatening or resulted in death, hospitalization or prolongation of hospitalization, a congenital anomaly, persistent or significant disability/incapacity, or important medical events requiring medical or surgical intervention to prevent a serious outcome."|Weeks 1-4 and Overall (from Week 1 through 30 days after the end of the LCIG Treatment Period; median duration of LCIG device exposure was 428 days)|The Safety dataset||Participants|||Count of Participants
667786|NCT01735396|Secondary|Safety of Abiraterone|To determine the safety of abiraterone Adverse events as defined by CTCAE v4. Number of participants with serious adverse events grade 4 or 5|up to 12 weeks|||Participants|||Count of Participants
667787|NCT01735396|Secondary|Bone Scan|"post-treatment changes in bone scans (as per PCWG2 guidelines) (no new lesions versus new lesions.)"|up to 12 weeks|data not collected|||||
667756|NCT01736176|Secondary|Number of Participants Who Used Healthcare Resources During the First 4 Weeks|"Use of healthcare resources was assessed by the investigator using the Health Resource Utilization Questionnaire (HRUQ), a questionnaire developed by the Sponsor regarding the use of healthcare resources due to the participant's Parkinson's disease. The Week 4 version of the questionnaire addressed the following questions during the first four weeks after the PEG-J procedure:
Has the subject had a visit to an emergency room?
Has the subject had a visit to an urgent care?
Has the subject had an outpatient visit to a neurologist?
Has the subject had an outpatient visit to a gastroenterologist, surgeon, or interventional radiologist?
Has the subject had an outpatient visit to a primary care physician?
Has the subject called the nursing support line?
Has the subject called a physician?"|Weeks 1-4|The Safety dataset included all participants who underwent the PEG-J placement procedure||Participants|||Count of Participants
667757|NCT01736176|Primary|Change From Baseline to Week 12 in the Non-Motor Symptom Scale (NMSS) Total Score|"The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastro-intestinal tract, urinary, sexual function, and miscellaneous (pain, taste/smell, weight change, excessive sweating). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent).
Item scores are calculated as the product of severity and frequency; the total score is obtained by summing the item scores. The NMSS total score ranges from 0 to 360 with a lower score indicating fewer symptoms; a negative change from baseline indicates improvement in symptoms."|Baseline and Week 12|The Efficacy dataset included all participants who received at least 1 infusion of LCIG study drug and had a baseline and LCIG Treatment Period observation for at least one efficacy or health outcome measure.||units on a scale||Standard Error|Least Squares Mean
667758|NCT01735916|Secondary|Reverse Remodeling by Echocardiography|"The change in LVEF between study groups.
Note: No subjects completed 24 months of follow-up, so this objective could not be analyzed."|Assessed from baseline visit to 24-month follow-up visit||||||
667759|NCT01735916|Secondary|Quality of Life (QoL)|"The quality of life between study groups and the change in quality of life over time between study groups using clinically accepted quality of life measures.
Note: No subjects completed 24 months of follow-up, so this objective could not be analyzed.
Two QOL questionnaires were used in the study.
EQ-5D: scores typically range from 0-1, where higher scores reflect better quality of life KCCQ: scores range from 0-100, where higher scores reflect better quality of life"|Assessed from baseline visit to 24-month follow-up visit||||||
667760|NCT01735916|Secondary|Recurrent HF Events|"The frequency of HF events between the study groups
Note: No endpoints were reached, so this objective was not analyzed
- HF Event, defined as either:
Inpatient hospitalization for HF, or
Outpatient event requiring invasive clinical intervention and management for HF (i.e. IV diuretics, ultrafiltration, or equivalent) and overnight stay"|From date of randomization to date of event, assessed for a minimum of 24 months and up to 60 months||||||
667761|NCT01735916|Secondary|Mortality or Heart Failure Morbidity or Worsening Systolic Function|"Secondary Composite Efficacy Endpoint: The time to first event, with event defined as:
All-cause mortality
HF Event, defined as either:
Inpatient hospitalization for HF, or
Outpatient event requiring invasive clinical intervention and management for HF (i.e. IV diuretics, ultrafiltration, or equivalent) and overnight stay, or
Worsening systolic function meeting an ICD/CRT-D indication, defined as:
A drop in LVEF to 35% or below, with an absolute decrease of greater than or equal to 10%, after maximum tolerated doses of guideline HF medications have been established
Note: No endpoints were reached, so this objective was not analyzed"|From date of randomization to date of event, assessed for a minimum of 24 months and up to 60 months||||||
667762|NCT01735916|Secondary|Mortality|"Time to death between the study groups
Note: No endpoints were reached, so this objective was not analyzed"|From date of randomization to date of death, for a minimum of 24 months and up to 60 months||||||
667763|NCT01735916|Primary|System-related Complication|"Primary Safety Endpoint: Time to first system-related complication in subjects with a successful implant.
Note: Because of the small number of subjects, number of complications was noted between arms and a time to event analysis was not performed.
Complication is defined as: An adverse event that results in death, involves any termination of significant device function, or requires an invasive intervention"|From the date of implant to the date of 6 month follow-up visit|||Complications|||Number
667764|NCT01735916|Primary|Mortality or Heart Failure Morbidity|"Primary Efficacy Endpoint: The time to first event, with event defined as:
All-cause mortality, or
HF Event, defined as either:
Inpatient hospitalization for HF, or
Outpatient event requiring invasive clinical intervention and management for HF (i.e. IV diuretics, ultrafiltration, or equivalent) and overnight stay
Note: No endpoints were reached, so this objective was not analyzed"|From date of randomization to date of event, assessed for a minimum of 24 months and up to 60 months||||||
667765|NCT01735877|Secondary|Modified Rankin Scale (mRS)|"0 - No symptoms at all / 1 - No significant disability despite symptoms / 2 - Slight disability / 3 -Moderate disability, but able to walk without assistance / 4 - Moderate disability and unable to walk without assistance / 5 - Severe disability / 6 – death
0-2: Good outcome 3-6: Poor outcome"|Baseline, 1,3 and 6 months|||participants|||Number
667766|NCT01735877|Primary|Change From Baseline in Picture Identification Task at 1,3, and 6 Months|PIT consisted of 10 pictures on A4 size paper and patients were asked to identify pictures. More the number of pictures identified, lesser was the neglect.|Baseline, 1,3 and 6 months|The number of participants are different as mentioned in the flow algorithm since 1 patient from the control group died at 3 months follow up. This patient is included in secondary outcome measures i.e. modified Rankin Scale (mRS)||pictures||95% Confidence Interval|Mean
667788|NCT01735396|Secondary|Time to Progression|post-treatment changes in measurable disease by time to disease progression (as per PCWG2 guidelines)|up to 12 weeks|data not collected|||||
667789|NCT01735396|Secondary|Response Assessment|Post-treatment changes in measurable disease by RECIST - Response Evaluation Criteria in Solid Tumors Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions|up to 12 weeks|||Participants|||Count of Participants
667767|NCT01735877|Primary|Change From Baseline in Line Bisection Test Scores at 1,3, and 6 Months|"The Line Bisection Test (LBT) consisted of three horizontal black lines, 20 cm long, one to the right, one central and one to the left side of a sheet of white paper (21cms X 30 cms). The patients were asked to ﬁnd and mark the centre of each line in turn. Errors away from true midline were measured, with leftward errors being given a negative sign, rightward errors a positive sign.
We took an absolute value for the change in error. The values for baseline to 1 month were calculated by subtracting baseline values from 1 month values. Then, the mean change was calculated for baseline to 1 month. Similar method was followed for the calculation of mean change in baseline to 3 months and 6 months.
The patients responses were similar for the three lines that they marked hence we took the first line for the interpretation. None of the patients had extreme errors like missed marking at 3 and 6 months."|Baseline, 1,3 and 6 months|The number of participants are different as mentioned in the flow algorithm since 1 patient from the control group died at 3 months follow up. This patient is included in secondary outcome measures i.e. modified Rankin Scale (mRS)||cms||95% Confidence Interval|Mean
667768|NCT01735877|Secondary|Functional Independence Measure|"The FIM consists of 13 motor and 5 social-cognitive items, assessing self-care, sphincter management, transfer, locomotion, communication, social interaction and cognition.14 It uses a 7-level scale anchored by extreme rating of total dependence as 1 and complete independence as 7; the intermediate levels are: 6 modiﬁed independence, 5 supervision or set-up, 4 minimal contact assistance, 3 moderate assistance and 2 maximal assistance.
For the purpose of analysis we divided FIM into two categories ≤5 dependent, ≥6 independent."|Baseline, 1, 3 and 6 months|The number of participants are different as mentioned in the flow algorithm since 1 patient from the control group died at 3 months follow up. This patient is included in secondary outcome measures i.e. modified Rankin Scale (mRS)||participants|||Number
667769|NCT01735877|Primary|Change From Baseline in Star Cancellation Test Scores at 1,3, and 6 Months|"The SCT consisted of a page containing 52 large stars, 10 short words and 13 letters, randomly positioned, with 56 small stars interspersed. Subjects were instructed to cross out (with a black pen) all the small stars across the page. The tester demonstrated by crossing out the two central stars. The cut off score to establish presence of unilateral visual neglect were: 51 or fewer stars cancelled for SCT.
Minimum score: 0 Maximum score: 54
Higher scores: better outcome"|Baseline, 1,3 and 6 months|The number of participants are different as mentioned in the flow algorithm since 1 patient from the control group died at 3 months follow up. This patient is included in secondary outcome measures i.e. modified Rankin Scale (mRS)||units on a scale||95% Confidence Interval|Mean
667770|NCT01735630|Secondary|Change From Baseline in ADCS-ADL Scores|The Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) (Galasko et al 1997) is a functional assessment that measures instrumental and basic activities of daily living. The total score for the 23-item ADCS-ADL ranges from 0 to 78 points, with lower scores indicating greater impairment in function.|Week 12|mITT population with available data for ADCS-ADL Scores||units on a scale||Standard Error|Mean
667771|NCT01735630|Secondary|Change From Baseline in MMSE Scores|The Mini-Mental State Exam (MMSE) (Folstein et al 1975) is a brief cognitive test assessing general cognitive function that has been employed in numerous clinical trials of products approved for the treatment of AD. The score can range from 0 to 30, with lower scores indicating greater impairment in function.|Week 12|mITT population with available data for MMSE Scores||units on a scale||Standard Error|Mean
667772|NCT01735630|Secondary|Change From Baseline in NPI Total Scores|The NPI (Cummings et al 1994) is a behavioral measure that assesses psychopathology in dementia subjects. It evaluates 12 neuropsychiatric disturbances common in dementia: delusions, hallucinations, agitation/aggression, dysphoria, anxiety, apathy, irritability, euphoria, disinhibition, aberrant motor behavior, nighttime behavior disturbances, and appetite and eating abnormalities. Higher scores on the NPI are associated with greater frequency and severity of symptoms. The scale range is 0-144.|Week 12|mITT population with available data for NPI Total Scores||units on a scale||Standard Error|Mean
667773|NCT01735630|Secondary|Change From Baseline in Modified-ADCS-CGIC Agitation Scores|The Alzheimer’s Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) is a widely used scale for the global assessment of change in AD trials.It is a 7-point Likert scale that ranges from marked improvement scored as 1 to marked worsening scored as 7, with no change scored as 4. The range is from 1 to 7. Higher scores indicate worsening agitation.|Week 12|mITT population with available data for Modified-ADCS-CGIC Agitation Scores||units on a scale||Standard Error|Mean
667774|NCT01735630|Primary|Change From Baseline in NPI-C Combined Agitation and Aggression Subscores (NPI-C A+A).|The NPI-C (de Medeiros et al 2010) is a validated and reliable behavioral measure that assesses psychopathology in dementia subjects. It evaluates 14 neuropsychiatric disturbances common in dementia.Higher scores on the NPI-C are associated with a greater clinical severity of symptoms. The NPI-C Agitation and Aggression score ranges from 0-63. The analysis of the NPI-C A+A score was performed on the mITT population.|Week 12|mITT||units on a scale||Standard Error|Mean
667775|NCT01735617|Secondary|AUC Values (Pmol*h/L) for ACTH|AUC values (pmol*h/L) for ACTH for the following reporting periods: 24 hours (2300-2300h), 2300-0700h, 0700-1500h and 1500-2300h|Specific time points (2300-2300h, 2300-0700h, 0700-1500h and 1500-2300h)|||pmol*h/L||Standard Deviation|Mean
667776|NCT01735617|Secondary|AUC Values (Nmol*h/L) for 17-OHP|AUC values (nmol*h/L) for 17-OHP for the following reporting periods: 24 hours (2300-2300h), 2300-0700h, 0700-1500h and 1500-2300h|Specific time points (2300-2300h, 2300-0700h, 0700-1500h and 1500-2300h)|||nmol*h/L||Standard Deviation|Mean
667777|NCT01735617|Secondary|AUC Values (Nmol*h/L) for Androstenedione|AUC values (nmol*h/L) for Androstenedione for the following reporting periods: 24 hours (2300-2300h), 2300-0700h, 0700-1500h and 1500-2300h|Specific time points (2300-2300h, 2300-0700h, 0700-1500h and 1500-2300h)|||nmol*h/L||Standard Deviation|Mean
667778|NCT01735617|Secondary|ACTH Levels at 0700h, 1700h and 2300h|ACTH levels at 0700h, 1700h and 2300h|Specified time points (0700h, 1700h and 2300h)|||pmol/L||Standard Deviation|Mean
667779|NCT01735617|Secondary|Androstenedione Levels at 0700h, 1700h and 2300h|Androstenedione levels at 0700h, 1700h and 2300h|Specified time points (0700h, 1700h and 2300h)|||nmol/L||Standard Deviation|Mean
667780|NCT01735617|Secondary|17-OHP Levels at 0700h, 1700h and 2300h|17-OHP levels at 0700h, 1700h and 2300h|Specified time points (0700h, 1700h and 2300h)|||nmol/L||Standard Deviation|Mean
667952|NCT01732835|Secondary|LV Mass - Change From Baseline|Left ventricular mass. Transthoracic echocardiography parameter.|Baseline and 6 months|Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.||g||Standard Deviation|Mean
667790|NCT01735396|Primary|Number of Participants With ≥ 30% Change in PSA|The primary objective of this study is to determine a correlation between inherited genetic polymorphisms and antitumor activity (as defined by a decline in PSA of ≥ 30%) in AA patients with castration-resistant prostate cancer treated with Abiraterone. The primary endpoint is the percent change in PSA from baseline to 12 weeks. A decline of ≥ 30% will be correlated with germline SNPs.|baseline and 12 weeks|||Participants|||Count of Participants
667791|NCT01735214|Primary|Change From Baseline in Intraocular Pressure (IOP) in the Left Eye|IOP is a measurement of the fluid pressure inside the eye. A negative change from Baseline indicates an improvement.|Baseline, Week 12|All participant with IOP data at Baseline and Week 12 for analysis.||mmHg||Standard Deviation|Mean
667792|NCT01735214|Secondary|Percentage of Participants Reaching Individual IOP Target After 12 Weeks||12 Weeks|All participants||percentage of participants|||Number
667793|NCT01735214|Secondary|Physician Assessment of Efficacy Using a 5-Point Scale|The physician evaluated efficacy (IOP lowering) using a 5-Point Scale: IOP lower than target, Reached Target IOP, IOP decreased but target not reached, No change or IOP increased. The percentage of participants in each category is reported.|12 Weeks|All participants.||percentage of participants|||Number
667794|NCT01735214|Secondary|Physician Assessment of Adherence to New Treatment Using a 4-Point Scale|The physician assessed the participant's adherence to new treatment using the following scale: Not Applicable, Worse, Equal or Better. The percentage of participants in each category is reported.|12 Weeks|All Participants||percentage of participants|||Number
667795|NCT01735214|Secondary|Percentage of Participants Who Continue the New Treatment After 12 Weeks||12 Weeks|All participants||percentage of participants|||Number
667796|NCT01735214|Secondary|Percentage of Participants Who Discontinue the Use of New Treatment Prior to 12 Weeks||12 Weeks|All participants.||percentage of participants|||Number
667797|NCT01735214|Secondary|Physician Assessment of Tolerability With New Treatment Using a 4-Point Scale|The physician evaluated the patient’s tolerability of IOP-lowering medication therapy using a 4-Point Scale: Very good, Good, Moderate or Poor. Percentage of participants in each category is reported.|12 Weeks|All participants with data available for analysis.||percentage of participants|||Number
667798|NCT01735214|Secondary|Patient Assessment of Overall Tolerability With New Treatment Using a 4-Point Scale|The patient evaluated the tolerability of IOP-lowering medication therapy using a 4-Point Scale: Very good, Good, Moderate or Poor. Percentage of participants in each category is reported.|12 Weeks|All participants with available data.||percentage of participants|||Number
667799|NCT01735214|Primary|Change From Baseline in Intraocular Pressure (IOP) in the Right Eye|IOP is a measurement of the fluid pressure inside the eye. A negative change from Baseline indicates an improvement.|Baseline, Week 12|All participant with IOP data at Baseline and Week 12 for analysis.||mmHg||Standard Deviation|Mean
667800|NCT01735201|Secondary|Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both CEA and SSA at 1 Hour Post-Dose on Day 28|Percentage of participants with at least a 2-grade decrease from Baseline (Improvement) in the CEA score and at least a 2-grade decrease from Baseline (Improvement) in the SSA score were assessed at 1 hour post-dose on Day 28. The investigator evaluated the severity of the participant's erythema (redness of the skin) as measured by the CEA using a 5-point scale where 0=clear skin with no signs of erythema; 1=almost clear of erythema, slight redness; 2=mild erythema, definite redness; 3=moderate erythema, marked redness and 4=severe erythema, fiery redness. The participant assessed the severity of their erythema as measured by the SSA using a 5-point scale where 0=clear of unwanted redness; 1=nearly clear of unwanted redness; 2=somewhat more redness than I prefer; 3=more redness than I prefer and 4=completely unacceptable redness.|Baseline, Day 28-hour 1|Modified intent-to-treat population included all randomized patients who applied study medication during the study, had both CEA and SSA measurements at Baseline and at least 1 post-baseline measurement for both CEA and SSA.||Percentage of participants|||Number
667801|NCT01735201|Secondary|Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both CEA and SSA at 0.5 Hour Post-Dose on Day 28|Percentage of participants with at least a 2-grade decrease from Baseline (Improvement) in the CEA score and at least a 2-grade decrease from Baseline (Improvement) in the SSA score were assessed at 0.5 hour post-dose on Day 28. The investigator evaluated the severity of the participant's erythema (redness of the skin) as measured by the CEA using a 5-point scale where 0=clear skin with no signs of erythema; 1=almost clear of erythema, slight redness; 2=mild erythema, definite redness; 3=moderate erythema, marked redness and 4=severe erythema, fiery redness. The participant assessed the severity of their erythema as measured by the SSA using a 5-point scale where 0=clear of unwanted redness; 1=nearly clear of unwanted redness; 2=somewhat more redness than I prefer; 3=more redness than I prefer and 4=completely unacceptable redness.|Baseline, Day 28-hour 0.5|Modified intent-to-treat population included all randomized patients who applied study medication during the study, had both CEA and SSA measurements at Baseline and at least 1 post-baseline measurement for both CEA and SSA.||Percentage of participants|||Number
667802|NCT01735201|Primary|Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA)|Percentage of participants with at least a 2-grade decrease from Baseline (Improvement) in the CEA score and at least a 2-grade decrease from Baseline (Improvement) in the SSA score were assessed on Day 28 hours 2 to 12. The investigator evaluated the severity of the participant's erythema (redness of the skin) as measured by the CEA using a 5-point scale where 0=clear skin with no signs of erythema; 1=almost clear of erythema, slight redness; 2=mild erythema, definite redness; 3=moderate erythema, marked redness and 4=severe erythema, fiery redness. The participant assessed the severity of their erythema as measured by the SSA using a 5-point scale where 0=clear of unwanted redness; 1=nearly clear of unwanted redness; 2=somewhat more redness than I prefer; 3=more redness than I prefer and 4=completely unacceptable redness.|Baseline, Day 28-hours 2 to 12|Modified intent-to-treat population included all randomized patients who applied study medication during the study, had both CEA and SSA measurements at Baseline and at least 1 post-baseline measurement for both CEA and SSA.||Percentage of participants|||Number
667803|NCT01735175|Secondary|Mortality Due to Infection|Number of patients with death due to infections|Study course (41 weeks)|FAS set = full analysis set||Participants|||Count of Participants
667940|NCT01732835|Secondary|Cardiac Output - Change From Baseline|Stroke volume x heart rate. Transthoracic echocardiography parameter.|Baseline and 6 months|Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.||l/min||Standard Deviation|Mean
667804|NCT01735175|Secondary|Frequency of Infections by Cycle and Across All Cycles|The number of patients with infections was recorded for each cycle and across all cycles. Infections were identified by the AE documentation page selecting all events coded with System Organ Class “Infections and Infestations”.|across all cycles (18 weeks)|Patients with more than 1 event during the study (overall) are counted only once. FAS set = full analysis set||Participants|||Count of Participants
667805|NCT01735175|Secondary|Time to ANC Recovery in Days in Cycle 1|Time to absolute neutrophil count (ANC) recovery in Cycle 1 was defined as the time in days from ANC nadir until the patient’s ANC had increased to ≥ 2 × 10^9 cells/L. Only the evaluable patients with a depth of ANC in Cycle 1 and a later increase of ANC ≥ 2 × 10^9 cells/L are given.|across Cycle 1 (3 weeks)|FAS set = full analysis set||days||Standard Deviation|Mean
667806|NCT01735175|Secondary|Number of Patients With ANC Nadir Per Day in Cycle 1|Numbers of patients with ANC nadir based per day during Cycle 1 are given.|Cycle 1 (3 weeks)|FAS set = full analysis set||Participants|||Count of Participants
667807|NCT01735175|Secondary|Depth of ANC Nadir in Cycle 1|The depth of ANC nadir was defined as the patient’s lowest ANC (10^9 cells/L) in Cycle 1. Only the evaluable patients with a depth of ANC in Cycle 1 are given.|Cycle 1 (3 weeks)|FAS set = full analysis set||10^9 cells/L||Standard Deviation|Mean
667808|NCT01735175|Secondary|Number of Patients With at Least One Episode of Fever by Cycle and Across All Cycles|Fever was defined as an oral temperature ≥ 38.3°C. Fever episodes were characterized by maximum oral temperature and the number of patients who had fever at least once.|across al cycles (18 weeks)|Patients with more than 1 event during the study (overall) are counted only once. FAS set = full analysis set||Participants|||Count of Participants
667809|NCT01735175|Secondary|Incidence of Febrile Neutropenia (FN)|FN was defined as an oral temperature ≥ 38.3°C while having an absolute neutrophil count (ANC) < 0.5 × 10^9 cells/L. Serious treatment-emergent adverse events (TEAEs) were reconciled with the fever and ANC results recorded in the patient diary and CRF and therefore only the serious TEAEs of FN (“febrile neutropenia”, “neutropenic sepsis”) were taken into account.|across all cycles (18 weeks)|Number of patients with at least one episode of febrile neutropenia by cycle and across all cycles (FAS set)||Participants|||Count of Participants
667810|NCT01735175|Primary|Mean Duration of Severe Neutropenia (DSN) During Cycle 1 of Chemotherapy|Mean duration of severe neutropenia, defined as number of consecutive days with ANC <0.5 × 10^9 cells/L (grade 4 neutropenia).|21 days (Cycle 1 of chemotherapy treatment)|FAS set = full analysis set; PP set = per protocol set||days||Standard Deviation|Mean
667811|NCT01734993|Secondary|Change From Baseline in CRP|Blood samples were collected for CRP, which is an acute phase reactant and a measure of inflammation. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.|Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)|Safety population. Here, N (number of participants analyzed) represents the participants who were evaluable for this outcome and 'n' represents the number of participants available for assessment at a given time point.||milligrams per liter (mg/L)||Standard Deviation|Mean
667812|NCT01734993|Secondary|Change From Baseline in ESR|Blood samples were collected for ESR, which is an acute phase reactant and provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeters per hour (mm/hr). A decrease in the level indicates reduction in inflammation and therefore improvement. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.|Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)|Safety population. Here, 'n' represents the number of participants available for assessment at a given time point.||mm/hr||Standard Deviation|Mean
667813|NCT01734993|Secondary|Change From Baseline in Physician’s Global Assessment of Disease Activity|The Physician’s Global Assessment of disease activity was assessed using a 0 to 100 mm horizontal VAS. The left-hand extreme of the line equals 0 mm, and is described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as “maximum disease activity”. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.|Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)|Safety population. Here, N (number of participants analyzed) represents the participants who were evaluable for this outcome and 'n' represents the number of participants available for assessment at a given time point.||mm||Standard Deviation|Mean
667814|NCT01734993|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Total Score|The HAQ-DI questionnaire measures functional status (disability) and health-related quality of life. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common activities over past week. Each question is evaluated according to the degree of severity on a 4-point scale. Total score for HAQ-DI was the average of all questions and ranges from 0 = without any difficulty to 3 = unable to do. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.|Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)|Safety population, Here, N (number of participants analyzed) represents the participants who were evaluable for this outcome and 'n' represents the number of participants available for assessment at a given time point.||Units on a scale||Standard Deviation|Mean
667941|NCT01732835|Secondary|LVEF - Change From Baseline|Left ventricular ejection fraction. Transthoracic echocardiography parameter.|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.||percentage of blood volume||Standard Deviation|Mean
667815|NCT01734993|Secondary|Change From Baseline in Patient's Assessment of Pain|Patient's assessment of pain over the previous 24 hours: using a VAS, left end of the line 0 mm=no pain to right end of the line 100 mm=unbearable pain. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.|Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)|Safety Population. Here, 'n' represents the number of participants available for assessment at a given time point.||mm||Standard Deviation|Mean
667816|NCT01734993|Secondary|Change From Baseline in PtGA of Disease Activity|PtGA of disease activity over the previous 24 hours using a 100 mm VAS where left end of the line 0 mm =no disease activity and right end of the line 100 mm =maximum disease activity. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.|Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)|Safety population. Here, 'n' represents the number of participants available for assessment at a given time point.||mm||Standard Deviation|Mean
667817|NCT01734993|Secondary|Time to Concomitant Corticosteroid Dose Reduction|Time to corticosteroid dose reduction (days) = (Date of the first dose reduction of corticosteroid treatment - date of first drug intake of this extension study) + 1.|Baseline up to approximately 142 weeks|Safety population. Here, N (number of participants analyzed) represents the participants who had concomitant corticosteroid dose reduction.||Days||Full Range|Median
667818|NCT01734993|Secondary|Time to Concomitant Corticosteroid Discontinuation|Time to corticosteroid discontinuation = (End date of corticosteroid treatment - date of first drug intake of this extension study) + 1.|Baseline up to approximately 142 weeks|Safety population. Here N (number of participants analyzed) represents the participants who discontinued concomitant corticosteroids||Days||Full Range|Median
667819|NCT01734993|Secondary|Percentage of Participants With Concomitant Corticosteroid Dose Reduction||Baseline up to approximately 142 weeks|Safety population. Here, N (number of participants analyzed) represents the participants who received concomitant corticosteroids.||Percentage of participants|||Number
667820|NCT01734993|Secondary|Percentage of Participants With Concomitant Corticosteroid Discontinuation||Baseline up to approximately 142 weeks|Safety population. Here, N (number of participants analyzed) represents the participants who received concomitant corticosteroids.||Percentage of participants|||Number
667821|NCT01734993|Secondary|Percentage of Participants With Clinical Remission|Clinical remission defined as:DAS28-ESR score < 2.6 and/or SDAI score </= 3.3.DAS28 score is measure of subject’s disease activity calculated using TJC [28 joints],SJC [28 joints],PtGA of disease activity [ VAS:0mm= no disease activity to 100 mm=maximum disease activity] and ESR (mm/hr). DAS28 was calculated as DAS28-ESR = 0.56*sqrt (TJC28) + 0.28*sqrt(SJC28) + 0.70* ln ESR + 0.014*PtGA of disease activity. DAS28-ESR score ranged from 0 to approximately 10, higher score indicating more severe disease activity. SDAI was calculated =[SJC (28 joints) + TJC (28 joints) + VAS PtGA + VAS physician global assessment of disease activity+CRP level(mg/dL)]. VAS assessments:0 mm=no disease activity to 100 mm=maximum disease activity. SDAI score ranged from 0 to 86, with higher scores indicating increased disease activity.|Week 48, 108|Safety population. Here, N (number of participants analyzed) represents the number of participants evaluable for this outcome and ‘n’ represents the number of participants available for assessment at a given time point.||Percentage of participants|||Number
667822|NCT01734993|Secondary|Change From Baseline in SJC|For SJC, a total of 28 joints were assessed. The presence of a swollen joint was scored as 1 and absence as 0. Total score is calculated by adding the scores, which is ranging from 0 (best possible score or no swollen joint) to 28 (worse possible score or all swollen joints). Lower scores indicate no swollen joint and higher scores indicate worsening swollen joints. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.|Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)|Safety population. Here, 'n' represents the number of participants available for assessment at a given time point.||Swollen Joints||Standard Deviation|Mean
667823|NCT01734993|Secondary|Change From Baseline in TJC|For TJC a total of 28 joints were assessed. The presence of a tender joint was scored as 1 and absence as 0. Total score is calculated by adding the scores, which is ranging from 0 (best possible score or no tender joint) to 28 (worse possible score or all tender joints). Lower scores indicate no tender joint and higher scores indicate worsening tender joints. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.|Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)|Safety population. Here, 'n' represents the number of participants available for assessment at a given time point.||Tender Joints||Standard Deviation|Mean
667824|NCT01734993|Secondary|Change From Baseline in Simplified Disease Activity Index (SDAI) Score|The SDAI was calculated as (SJC [28 joints] + TJC [28 joints] + VAS ptGA + VAS physician global assessment of disease activity + C-reactive Protein (CRP) level in milligram/deciliter [mg/dL]). VAS assessments: 0 centimeters (cm)=no disease activity to 10 cm=maximum disease activity. SDAI score ranged from 0 to 86, with higher scores indicating increased disease activity. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.|Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)|Safety population. Here, N (number of participants analyzed) represents the number of participants evaluable for this outcome and 'n' represents the number of participants available for assessment at a given time point.||Units on a scale||Standard Deviation|Mean
667825|NCT01734993|Secondary|Change From Baseline in Disease Activity Score 28 - Erythrocyte Sedimentation Rate (DAS28-ESR) Score|The DAS 28 ESR score is a measure of the participant’s disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient’s global assessment (PtGA) of disease activity (visual analog scale [VAS]: 0 millimeter [mm] = no disease activity to 100 mm=maximum disease activity) and the erythrocyte sedimentation rate (ESR in millimeters per hour [mm/hr]). DAS28 was calculated using following formulas: DAS28-ESR = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt (SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*PtGA of disease activity. A total possible score of 0 to approximately 10, with higher score indicating more severe disease activity. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.|Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)|Safety population. Here, 'n' represents the number of participants available for assessment at a given time point.||Units on a scale||Standard Deviation|Mean
667826|NCT01734993|Primary|Percentage of Participants With Anti-TCZ Antibodies||Baseline up to approximately 142 weeks|Safety population||Percentage of participants|||Number
667827|NCT01734993|Primary|Percentage of Participants With Clinically Significant Laboratory Abnormalities|Criteria for laboratory tests clinically significant abnormalities included: hemoglobin, hematocrit and red blood cells (RBCs)(< 0.8*lower limit of normal[LLN]); leucocytes (<0.6/greater than [>]1.5*upper limit of normal [ULN]); platelets (<0.5*LLN></0>1.75*ULN); neutrophils, lymphocytes (<0.8*LLN></0>1.2*ULN); eosinophils, basophils, monocytes (>1.2*ULN); total bilirubin, direct bilirubin, indirect bilirubin (>1.5*ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (>3*ULN), total protein, albumin (<0.8*LLN></0>1.2*ULN); creatinine, urea (>1.3*ULN); glucose (<0.6*LLN></0>1.5*ULN); uric acid (>1.2*ULN); sodium, potassium, chloride, calcium, bicarbonate (<0.9*LLN></0>1.1*ULN); urine RBCs, urine white blood cells (WBCs) (> or equal[=]20 high-powered field), urine bacteria >20 high-powered field. Overall percentage of participants with any clinically significant laboratory abnormality was reported.|Baseline up to approximately 142 weeks|Safety population||Percentage of participants|||Number
667828|NCT01734993|Primary|Percentage of Participants With Clinically Significant Physical Examinations and Vital Signs Abnormalities|Criteria for potentially clinically important (PCI) change in vital signs: heart rate value of less than (<) 40 beats per minute and value greater than (>) 150 beats per minute, systolic blood pressure (SBP) of < 80 or >210 millimeter of mercury (mmHg), diastolic blood pressure (DBP) of <40 or >130 mmHg, body temperature <32 or > 40 degrees Celsius, respiratory rate of <10 or > 50 breaths/minute and criteria for PCI change in physical examination: >/=10% increase or decrease of body weight in kilograms (kg).|Baseline up to approximately 142 weeks|Safety population||Percentage of participants|||Number
667829|NCT01734993|Primary|Percentage of Participants With AEs Leading to TCZ Discontinuation, Interruption, or Dose Modification|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Percentage of participants with AE causing drug discontinuation, interruption and increase or decrease in dose of drug was presented.|Baseline up to approximately 142 weeks|Safety Population||Percentage of participants|||Number
667830|NCT01734993|Primary|Percentage of Participants With AESIs Related to TCZ|AESI for this study included: infections (including opportunistic infections), myocardial infarction/acute coronary syndrome, gastrointestinal perforation and related events, malignancies, anaphylaxis / hypersensitivity reactions, demyelinating disorders, stroke, bleeding events and hepatic events. Percentage of participants with AESI related to the drug were presented. Causality of AESIs based on physician’s discretion: certain (AE after drug intake, not explained by other drugs, reaction on DC, relapse on re-intake of drug), probable/likely (AE after drug intake, not explained by other drugs, reaction on DC, no information on re-intake), possible (AE after drug intake, explained by other drugs, no information on DC), unlikely (not related to drug intake time, explained by other drugs). AESIs with causality of certain, probable/likely, and possible were considered TCZ related.|Baseline up to approximately 142 weeks|Safety population||Percentage of participants|||Number
667831|NCT01734993|Primary|Percentage of Participants With Adverse Events of Special Interest (AESIs)|Adverse events of special interest (AESI) for this study included: infections (including opportunistic infections), myocardial infarction/acute coronary syndrome, gastrointestinal perforation and related events, malignancies, anaphylaxis / hypersensitivity reactions, demyelinating disorders, stroke, bleeding events and hepatic events.|Baseline up to approximately 142 weeks|Safety population||Percentage of participants|||Number
667832|NCT01734993|Primary|Percentage of Participants With AEs and SAEs Related to TCZ|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included SAEs as well as non-serious AEs. Causality of AEs based on physician’s discretion: certain (AE after drug intake, not explained by other drugs, reaction on drug cessation [DC], relapse on re-intake of drug), probable/likely (AE after drug intake, not explained by other drugs, reaction on DC, no information on re-intake), possible (AE after drug intake, explained by other drugs, no information on DC), unlikely (not related to drug intake time, explained by other drugs). AEs with causality of certain, probable/likely, and possible were considered TCZ related.|Baseline up to approximately 142 weeks|Safety population||Percentage of participants|||Number
667833|NCT01734993|Primary|Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An adverse event (AE) was defined as any untoward medical occurrence in a participant who was administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment. A SAE was any untoward medical occurrence that at any dose resulted in death, was life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity, and congenital anomaly/birth defect. AEs included SAEs as well as non-serious AEs.|Baseline up to approximately 142 weeks|Safety population||Percentage of participants|||Number
667834|NCT01734889|Secondary|The Palatability Scores on Day 3 (Subjects 5 - < 18 Years)|Patients rated the palatability of the suspension. The following grading was applied: 5 (very good), 4 (good), 3 (neither good nor bad), 2 (bad) and 1 (very bad).|Day 3|Full analysis set: All subjects who received at least one dose of study drug and had at least taste or acceptability assessment.||units on a scale||Full Range|Median
667835|NCT01734889|Secondary|The Palatability Scores on Day 2 (Subjects 5 - < 18 Years)|Patients rated the palatability of the suspension. The following grading was applied: 5 (very good), 4 (good), 3 (neither good nor bad), 2 (bad) and 1 (very bad).|Day 2|Full analysis set: All subjects who received at least one dose of study drug and had at least taste or acceptability assessment.||units on a scale||Full Range|Median
667836|NCT01734889|Secondary|The Palatability Scores on Day 1 (Subjects 5 - < 18 Years)|Patients rated the palatability of the suspension. The following grading was applied: 5 (very good), 4 (good), 3 (neither good nor bad), 2 (bad) and 1 (very bad).|Day 1|Full analysis set: All subjects who received at least one dose of study drug and had at least taste or acceptability assessment.||units on a scale||Full Range|Median
667837|NCT01734889|Primary|The Acceptability Score for the Last Dose of the Suspension on Day 3 for Subjects < 5 Years|The parents of patients aged <5 years rated their child´s acceptability of the suspension. The following grading was applied: 5 (very well), 4 (well), 3 (neither well nor badly), 2 (badly) and 1 (very badly).|Day 3|Full analysis set: All subjects who received at least one dose of study drug and had at least one taste or acceptability assessments||units on a scale||Full Range|Median
667838|NCT01734889|Primary|The Taste Score for the Last Dose of the Suspension on Day 3 for Subjects 5 - <18 Years|Patients rated the taste of the suspension. The following grading was applied: 5 (very good taste), 4 (good taste), 3 (neither good nor bad taste), 2 (bad taste) and 1 (very bad taste).|Day 3|Full analysis set: All subjects who received at least one dose of study drug and had at least one taste or acceptability assessments||units on a scale||Full Range|Median
667839|NCT01734785|Secondary|Body Weight Change From Baseline After 24 Weeks of Double-blind Treatment|Change from baseline Body weight after 24 weeks of treatment with double-blind trial medication.|Baseline and 24 weeks|FAS (OC)||kg||Standard Error|Least Squares Mean
667840|NCT01734785|Secondary|Fasting Plasma Glucose (FPG) Change From Baseline After 24 Weeks of Double-blind Treatment.|Change from baseline FPG (mmol/L) after 24 weeks of treatment with double-blind trial medication.|Baseline and 24 weeks|FAS (OC)||mmol/L||Standard Error|Least Squares Mean
667841|NCT01734785|Primary|HbA1c Change From Baseline After 24 Weeks Double-blind Randomized Treatment|Change from baseline in Glycated haemoglobin (HbA1c) [%] after 24 weeks of treatment with double-blind trial medication. Baseline was defined as the last observation before the first intake of any double-blind randomised trial medication. The term ‘baseline’ was not used to refer to measurements before the administration of open-label medication.|Baseline and 24 weeks|The full analysis set (FAS) consisted of all patients in the treated set (TS) who had a baseline HbA1c assessment and at least 1 on-treatment HbA1c assessment during the double-blind part of the trial. Observed Case (OC): In the OC analysis, values after the use of rescue medication were set to missing.||Percentage of HbA1c||Standard Error|Least Squares Mean
667842|NCT01734772|Primary|Total Dabigatran: Maximum Measured Concentration at Steady State (Cmax,ss)|Maximum measured concentration of the analyte in plasma at steady state (Cmax,ss).|47.55, 48.30,49, 49.30,50,50.30,51,52,54,56, 60 hours|Pharmacokinetic set: This subject set included all subjects in the TS who provided at least 1 observation for at least 1 PK endpoint without important protocol violations relevant to the evaluation of bioavailability and who had not vomiting at or before 2 times the median tmax,ss of the trial medications on PK study days of both trial parts.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
667843|NCT01734772|Primary|Total Dabigatran: Area Under the Concentration-time Curve at Steady State Over the Uniform Dosing Interval τ (AUCτ,ss)|Area under the concentration-time curve of dabigatran etexilate in plasma at steady state over the uniform dosing interval τ (AUCτ,ss).|47.55, 48.30,49, 49.30,50,50.30,51,52,54,56, 60 hours|Pharmacokinetic set: This subject set included all subjects in the TS who provided at least 1 observation for at least 1 PK endpoint without important protocol violations relevant to the evaluation of bioavailability and who had not vomiting at or before 2 times the median tmax,ss of the trial medications on PK study days of both trial parts.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
667844|NCT01734655|Primary|Correlation of the MEQ Subscales to the MAAS|The convergent validity of the MEQ was also assessed by calculating the pearson correlation between the MEQ subscales and the Mindful Attention Awareness Scale (MAAS). Correlations were run with and without the External Cues subscale since it was found not to be internally consistent. **Indicates correlation significant at the .01 level|V1|||correlation coefficients|||Number
667845|NCT01734655|Primary|Convergent Validity of the MEQ Subscales Compared to the EI Hunger Subscale|The convergent validity of the Mindful Eating Questionnaire was assessed using the Eating Inventory subscales of restraint, disinhibition and hunger by calculating the Pearson correlation coefficients. Below are the results for the comparison of the Mindful Eating Questionnaire's subscales to the Eating Inventory Subscale of Hunger. Correlations were run with and without the External Cues subscale since it was found not to be internally consistent.|V1|||correlation coefficients|||Number
667846|NCT01734655|Primary|Convergent Validity of the Mindful Eating Questionnaire Subscales to the Eating Inventory Disinhibition Subscale|The convergent validity of the Mindful Eating Questionnaire was assessed using the Eating Inventory subscales by calculating the Pearson correlation coefficients. Below are the results for the comparison of the Mindful Eating Questionnaire's subscales to the Eating Inventory Subscale of Disinhibition. Correlations were run with and without the External Cues subscale since it was found not to be internally consistent.|V1|||correlation coefficients|||Number
667847|NCT01734655|Primary|Convergent Validity of the Mindful Eating Questionnaire Compared to the Eating Inventory (EI) Restraint Subscale|The convergent validity of the Mindful Eating Questionnaire was assessed using the Eating Inventory (EI) subscales (restraint, disinhibition, hunger) by calculating Pearson correlation coefficients. Below are the results for the comparison of the Mindful Eating Questionnaire's subscales to the Eating Inventory restraint subscale. Correlations were run with and without the External Cues subscale (ECS) since it was found not to be internally consistent.|V1|Pregnant women who were overweight or obese and 18-40 yrs of age.||correlation coefficients|||Number
667953|NCT01732835|Secondary|Mean Gradient - Change From Baseline|Transthoracic echocardiography parameter|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.||mm Hg||Standard Deviation|Mean
667848|NCT01734655|Primary|To Determine the Internal Validity of Each of the MEQ's Subscales, we Calculated Cronbach's a|"Cronbach's alpha is a measure of internal consistency, that is, how closely related a set of items are as a group. It is considered to be a measure of scale reliability. Alpha coefficients generally range from 0 to 1, with a higher score indicating greater reliability of a scale. However, a high value for alpha does not imply that the measure is unidimensional. Technically speaking, Cronbach's alpha is not a statistical test - it is a coefficient of reliability (or consistency)."|V1|Pregnant women who were overweight or obese and 18-40 yrs of age.||Ratio of Variance|||Number
667849|NCT01734655|Primary|Test-Retest Reliability of the Mindful Eating Questionnaire (MEQ)|Participants were given the Mindful Eating Questionnaire (MEQ) at their screening visit and study visit in an effort to establish test-retest reliability.|SV and V1; minimum of 24 hours between visits, maximum of 5 months between visits|||test-retest coefficent|||Number
667850|NCT01734551|Secondary|Bayley Scales of Infant and Toddler Development Third Edition|Scores obtained Bayley Scales of Infant and Toddler Development Third Edition in the developmental domains of motor, cognitive, and language. This tool for measures of motor, cognitive and language development is a series of standardized measurements and for each domain, the standardized scores have a mean of 100 and standard deviation of 15. Scores below 1 standard deviation (= or less than 84) is considered below normal. Scores above 1 standard deviation (over 115) represent higher than normal functioning in each domain The score for each domain (motor, cognitive, and language functioning) represents the full-scale score|1 year of life|The above number fo reach arm represents the number of subjects who came for follow-up evaluation.||scores on a scale||Standard Deviation|Mean
667851|NCT01734551|Secondary|Neurobehavioral Performance Summary Scores From the Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS)|The summary scores from the Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS) give a measure of infant neurobehavior in the following areas (score range): habituation (1-9), regulation (2.20-7.50), attention (1.29 -8.4), Handling (0 - 1), quality of movement (1.20 - 6.20), Non-optimal reflexes (0-12), Asymmetric reflexes (0-7), arousal (2.43 - 6.67), hypertonicity (0- 8), hypotonicity (0 - 5.0), excitability (0-11), lethargy (0 - 11.0). and stress/abstinence (0. - 0.57). A higher score for each item means a higher level of the construct. For example, a higher score for hypertonicity means the infant is more hypertonic and higher score on hypotonicity means the infant is more hypotonic. No cut-off score published for normal or abnormal behavioral performance. Reference: Lester BM et al. Summary Statistics of Neonatal Intensive Care Unit Network Neurobehavioral Scale Scores From the Maternal Lifestyle Study: A Quasinormative Sample, in Pediatrics 2004; 113,668.|5-10 days after treatment starts|||scores on a scale||Standard Error|Mean
667852|NCT01734551|Primary|Duration of Treatment|Total number days of treatment|120 days|||days||Full Range|Median
667853|NCT01734551|Primary|Finnegan Neonatal Abstinence Scoring System|Mean of total Finnegan Scores obtained every 3 hours on days 2, 7, and 14 following start of treatment; A score is a number representing the total score or sum from 21 items or symptoms or manifestations of opiate withdrawal in newborn infants. The total score ranges from 0 to 43. Reference: 1. Finnegan LP, Connaughton JF, Jr., Kron RE, et al. Neonatal abstinence syndrome: assessment and management. Addict Dis 1975;2(1-2):141-58. Although normal newborn may manifest mild symptoms that will give scores in the range of 0 to 7. A score of 8 consecutively obtained times 3 indicate that infant will benefit from treatment, in this study morphine or clonidine. A decrease in scores especially to less than 8 is suggestive of a good response to treatment.|14 days|||scores on a scale||Standard Deviation|Mean
667854|NCT01734395|Secondary|Change From Screening at Week 16 in Mini Mental State Exam Scores (MMSE)|MMSC is a brief 30-point questionnaire test that is used for the assessment of dementia patients’ cognitive impairment. Evaluation of points are as: 24-30 = No cognitive impairment, 18-23 = Mild cognitive impairment, 0-17 = Severe cognitive impairment. Lower scores indicate worsening.|Baseline, Week 16|FAS was used for the analysis. The FAS population was defined as the participants who satisfied the inclusion/exclusion criteria||Units on a scale||Standard Deviation|Mean
667855|NCT01734395|Primary|Change From Baseline at Week 16 in Burden Interview (BI) Scores|BI is designed to evaluate subjective stress dementia patients’ caregivers experience in relation to caregiving. It has total 22 questions with 4 options each and the calculated scores are from 1 to 88 (0-20 = Little or no burden, 21-40 = Mild to moderate burden, 41-60 = Moderate to severe burden, 61-88 = Severe burden). Higher scores indicate worsening.|Baseline, Week 16|FAS was used for the analysis. The FAS population was defined as the participants who satisfied the inclusion/exclusion criteria and received the study drug at least once and whose evaluation visit was performed at least once in addition to the visit at baseline.||Units on a scale||Standard Deviation|Mean
667856|NCT01734395|Primary|Change From Baseline at Week 16 in Attention Questionnaire Scores (AQS)|AQS evaluates the attention of participants with dementia and is designed for their caregivers to evaluate the participant’s attention directly. It has 15 questions devised to be suitable for cultural characteristics of Korea through the standardization study considering education and gender/culture gap. Each question is scored from 0 to 2 (0=never, 1=occasionally, 2=usually). In questions 1 to 8, the lower participant attention ability rated the higher score (AQS1), In questions 9 to 15, the higher participant attention ability rated the higher score (AQS2). The total score is calculated by the formula: 16-AQS1+AQS2 and the range is from 0 to 30. Higher score means better attention ability of participant.|Baseline (Week 1 [Day 1]), Week 16|FAS (Full Analysis Set) was used for the analysis. The FAS population was defined as the participants who satisfied the inclusion/exclusion criteria and received the study drug at least once and whose evaluation visit was performed at least once in addition to the visit at baseline.||Units on a scale||Standard Deviation|Mean
667857|NCT01734317|Secondary|Pain|Pain before, during and after dressing removal will be meausered.|After 14/21 days treatment||||||
667858|NCT01734317|Primary|Efficacy|Healing at day 14. Healing was defined as ≥95% epithelialisation.|14 days|||participants|||Number
667859|NCT01734239|Primary|Number of Participants Reporting Serious Adverse Experiences|A serious AE (SAE) is an AE that 1) results in death, 2) is life threatening, 3) results in a persistent or significant disability or incapacity, 4) results in or prolongs an existing inpatient hospitalization, 5) is a congenital anomaly or birth defect, 6) is a cancer, 7) is an overdose, or 8) is another important medical event which, based on appropriate medical judgment, may jeopardize the participant and may require medical or surgical intervention|Up to Day 28 postvaccination|The All Subjects as Treated population included all enrolled participants||Number of participants|||Number
667860|NCT01734239|Primary|Number of Participants Reporting an Injection-site or Systemic Adverse Experience That Was Reported by >=4 Participants|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor’s product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor’s product, is also an AE. Injection-site or systemic AEs that occurred in >=4 participants were reported for this endpoint.|Up to Day 14 postvaccination|The All Subjects as Treated population included all enrolled participants||Number of participants|||Number
667861|NCT01734239|Primary|Number of Participants With Elevated Body Temperature (>=37.6 °C Axillary / >=38.0 °C Oral or Equivalent)||Up to 5 days postvaccination|The All Subjects as Treated population included all enrolled participants||Number of participants|||Number
667862|NCT01734239|Primary|Percentage of Participants With >=2-fold Increase From Prevaccination to Postvaccination in Antibodies to Pneumococcal Serotypes Contained in the Vaccine|Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays. A >=2-fold increase in serum antibody is a marker for serologic response to pneumococcal vaccination in adults.|Day 28 postvaccination|The per protocol immunogenicity population included all enrolled participants except 2 who were excluded because blood samples were collected outside the allowable day range||Percentage of participants||95% Confidence Interval|Number
667863|NCT01734239|Primary|Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Contained in the Vaccine|Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays|Prevaccination and Day 28 after vaccination|The per protocol immunogenicity population included all enrolled participants except 2 who were excluded because blood samples were collected outside the allowable day range||ug/mL||95% Confidence Interval|Mean
667864|NCT01734161|Primary|Incidence of Post-operative Nausea and/or Vomiting|The patient's self report of nausea and incidence of vomiting will be recorded intra-operatively, upon arrival to the PACU and at 1, 3, 6, 24, and 48 hours after surgery|48 hours|||Participants|||Count of Participants
667865|NCT01733953|Secondary|Change From Baseline in Carotid Intima-Media Thickness at 6-Months||Baseline and 6-Months|Discrepant sample sizes are due to lack of reliability of measures. If measures were unreliable they were excluded.||mm||95% Confidence Interval|Mean
667866|NCT01733953|Secondary|Change From Baseline in Augmentation Index at 6-Months||Baseline and 6-Months|Discrepant sample sizes are due to lack of reliability of measures. If measures were unreliable they were excluded.||P2/P1||95% Confidence Interval|Mean
667867|NCT01733953|Secondary|Change From Baseline in Pulse Wave Velocity at 6-Months||Baseline and 6-Months|Discrepant sample sizes are due to lack of reliability of measures. If measures were unreliable they were excluded.||m/s||95% Confidence Interval|Mean
667868|NCT01733953|Secondary|Change From Baseline in Carotid Artery Distensibility at 6-Months||Baseline and 6-Months|Discrepant sample sizes are due to lack of reliability of measures. If measures were unreliable they were excluded.||% distensibility||95% Confidence Interval|Mean
667869|NCT01733953|Secondary|Change From Baseline in Carotid Artery Compliance at 6-Months|Carotid Artery Compliance is a measure of arterial stiffness. Higher arterial stiffness places persons at higher risk for CVD.|Baseline and 6-Months|Discrepant sample sizes are due to lack of reliability of measures. If measures were unreliable they were excluded.||mm/mmHg x 10^-3||95% Confidence Interval|Mean
667870|NCT01733953|Primary|Change From Baseline in Brachial Artery Flow-Mediated Dilation at 6-months||Baseline and 6-Months|Physician withdrawals, loss to follow-up, drug compliance <70%, unrelated injury, and self-withdrawal reduced number analyzed. Also, participant movement during FMD assessment and/or poor ultrasound image quality due to difficult brachial artery anatomy or poor circulation led to some unusable data and thus lowered the analyzable sample size.||percentage change||95% Confidence Interval|Mean
667871|NCT01733758|Secondary|Time to Study Withdrawal for Any Reason|Time to withdrawal was calculated as the number of days between the date of first dose and the date of withdrawal plus 1. Time to withdrawal was summarized by visit.|Baseline through Week 52|Intent-to-Treat Population: all randomized participants who received at least 1 dose of study treatment and had a Baseline assessment and at least one post-Baseline assessment (scheduled or unscheduled) of the primary endpoint, HbA1c.||Weeks||95% Confidence Interval|Median
667872|NCT01733758|Secondary|Time to Study Withdrawal Due to Hyperglycemia|Participants who experienced persistent hyperglycemia after uptitration were to be withdrawn from the study. Hyperglycemia is defined as a fasting plasma glucose (FPG) ≥280 mg/dL (≥15.5 mmol/L) from ≥Week 2 to <Week 4, ≥250 mg/dL (≥13.9 mmol/L) from ≥Week 4 to <Week 12, or ≥230 mg/dL (≥12.8 mmol/L) from ≥Week 12 to <Week 52, confirmed a second evaluation within 7 days.|Baseline through Week 52|Intent-to-Treat Population: all randomized par. who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment. Par. who did not conform to the protocol-defined criteria of persistent hyperglycemia with respect to FPG values defined above were not included in this analysis.||Weeks||95% Confidence Interval|Median
667873|NCT01733758|Secondary|Change From Baseline in Body Weight at Week 52|The Baseline body weight value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the body weight value at Week 52 minus the value at Baseline.|Baseline and Week 52|Intent-to-Treat (Observed Case) Population: all randomized participants who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment. Participants who discontinued before Week 52 from study treatment were not included in the analysis. No missing data were imputed.||Kilograms (kg)||Standard Deviation|Mean
667874|NCT01733758|Secondary|Change From Baseline in Body Weight at Week 24|The Baseline body weight value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the body weight value at Week 24 minus the value at Baseline. Participants who discontinued from the study treatment before Week 24 had their last non-missing weight carried forward for the summary, unless the value is past 14 days after the last dose of study drug.|Baseline and Week 24|Intent-to-Treat (Last Observation Carried Forward) Population: all randomized participants who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment.||Kilograms (kg)||Standard Deviation|Mean
667942|NCT01732835|Secondary|LVEF - Change From Baseline|Left ventricular ejection fraction. Transthoracic echocardiography parameter.|Baseline and 6 months|Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.||percentage of blood volume||Standard Error|Mean
667875|NCT01733758|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52|FPG is an indicator of efficacy. The Baseline FPG value is defined as the last non-missing value on or before the start of treatment. Change from Baseline was calculated as the FPG value at Week 52 minus the FPG value at Baseline.|Baseline and Week 52|Intent-to-Treat (Observed Case) Population: all randomized participants who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment. Participants who discontinued from study treatment before Week 52 were not included in this analysis. No missing data were imputed.||Milligrams per deciliter (mg/dL)||Standard Deviation|Mean
667876|NCT01733758|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|FPG is an indicator of efficacy. The Baseline FPG value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the FPG value at Week 24 minus the FPG value at Baseline. Participants who discontinued from study treatment before Week 24 had their last post-Baseline FPG observation carried forward for the summary unless the value was 14 days past the last dose of study drug.|Baseline and Week 24|Intent-to-Treat (Last Observation Carried Forward) Population: all randomized participants who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment.||Milligrams per deciliter (mg/dL)||Standard Deviation|Mean
667877|NCT01733758|Secondary|Percentage of Participants Achieving Clinically Meaningful Levels of HbA1c (i.e., the Percentage of Participants Achieving Treatment Goal of <6.5% and <7.0%) at Week 52|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3 month period. Clinically meaningful levels of response in HbA1c are defined as <6.5% and <7.0%.|Week 52|Intent-to-Treat (Observed Case) Population: all randomized participants who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment. Participants who discontinued from study treatment before Week 52 were not included in the analysis. No missing data were imputed.||Percentage of participants|||Number
667878|NCT01733758|Secondary|Percentage of Participants Achieving Clinically Meaningful Levels of HbA1c (i.e., the Percentage of Participants Achieving Treatment Goal of <6.5% and <7.0%) at Week 24|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3 month period. Clinically meaningful levels of response in HbA1c are defined as <6.5% and <7.0%. Participants who discontinued the study before Week 24 had their last post-Baseline HbA1c value carried forwrad for the summary unless the value was past 14 days after the last dose of study drug.|Week 24|Intent-to-Treat (Last Observation Carried Forward) Population: all randomized participants who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment.||Percentage of participants|||Number
667879|NCT01733758|Secondary|Change From Baseline in HbA1c at Week 52|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3- month period. The Baseline HbA1c value is defined as the last non-missing value on or before the start of treatment. Change from Baseline was calculated as the value at Week 52 minus the value at Baseline.|Baseline and Week 52|Intent-to-Treat (Observed Case) Population: all randomized participants who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment. Participants who discontinued from study treatment before Week 52 were not included in the analysis. No missing data were imputed.||Percentage of HbA1c in the blood||Standard Deviation|Mean
667880|NCT01733758|Primary|Mean HbA1c at Baseline, Week 24, and Change From Baseline at Week 24|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3 month period. The Baseline HbA1c value is defined as the last nonmissing value before the start of treatment. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. Participants who discontinued from study treatment before Week 24 had their last post-Baseline HbA1c value carried forward for the summary, unless the value was past 14 days after the last dose of study drug. The open-label liraglutide group was a reference group; descriptive statistics comparing albiglutide and liraglutide were exploratory endpoints.|Baseline and Week 24|Intent-to-Treat Population (Last Observation Carried Forward): all randomized participants who received at least 1 dose of study treatment and had a Baseline assessment and at least 1 post-Baseline assessment of HbA1c on or before Week 24 provided it was not past more than 14 days after the last dose of study drug intake.||Percentage of HbA1c in the blood||Standard Deviation|Mean
667881|NCT01733758|Primary|Model-adjusted Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3 month period. The Baseline HbA1c value is defined as the last nonmissing value before the start of treatment. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. Based on analysis of covariance (ANCOVA): Change at Week 24 = treatment (placebo, albiglutide 30 mg, albiglutide 50 mg) + Baseline HbA1c + prior diabetes therapy + age category (<65 years versus ≥65 years). Participants who discontinued from study treatment before Week 24 had their last post-Baseline HbA1c carried forward for the analysis unless the value is past 14 days after the last dose of study drug. The open-label liraglutide group was a reference group and not included in the primary endpoint analysis model. Descriptive summary statistics are provided as a separate outcome measure.|Baseline and Week 24|Intent-to-Treat Population (Last Observation Carried Forward): all randomized participants who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment of HbA1c.||Percentage of HbA1c in the blood||Standard Error|Least Squares Mean
667882|NCT01733745|Secondary|Dry Eye Ocular Surface Disease Index (OSDI) Questionnaire Responses|The Dry Eye OSDI Questionnaire is a 12-question validated questionnaire [resultant overall 0-100 score, with 0 being none of the time (best) and 100 being all of the time (worst)] that measures ocular symptoms, visual function, and environmental factors that may affect a patient's vision. The OSDI questionnaire was completed by the patient with no assistance from the office staff, physician, or anyone else. Both eyes contributed to the mean.|Baseline, Month 1, Month 2, Month 3|This reporting group includes all subjects who were enrolled and received at least one of the study treatments.||units on a scale|Participants|Standard Deviation|Mean
667943|NCT01732835|Secondary|LV Systolic Volume - Change From Baseline|Left ventricular systolic volume. Transthoracic echocardiography parameter.|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.||ml||Standard Deviation|Mean
667883|NCT01733745|Secondary|Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire Responses|The Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire is a 16-question validated questionnaire (resultant overall score 0-28, with 0 being best and 28 being worst) that measures the frequency and severity of dry eye symptoms. The SPEED questionnaire was completed by the patient with no assistance from the office staff, physician, or anyone else. Both eyes contributed to the mean.|Baseline, Month 1, Month 2, Month 3|This reporting group includes all subjects who were enrolled and received at least one of the study treatments.||units on a scale|Participants|Standard Deviation|Mean
667884|NCT01733745|Primary|Number of Meibomian Glands Yielding Liquid Secretion (MGLYS)|Meibomian gland functionality was evaluated by the investigator using the Meibomian Gland Evaluator (MGE), a handheld instrument that provides a standardized method for applying consistent, gentle pressure to the outer skin of the lower eyelid. The total number of meibomian gland orificies evidencing liquid secretion during expression with the MGE, in both eyes, was recorded. A lower number of functioning meibomian glands may contribute to dry eye syndrome.|Baseline, Month 1, Month 2, Month 3|This reporting group includes all subjects who were enrolled and received at least one of the study treatments.||functioning glands|Participants|Standard Deviation|Mean
667885|NCT01733732|Secondary|Mean Change From Baseline in Intraocular Pressure (IOP) by Visit|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Baseline-adjusted values were tabulated. Each eye was assessed individually. Both eyes contributed to the mean.|Baseline (Day 0), Day 14, Day 30|"This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. Here, n is the number of eyes with non-missing values at the specific time point for each arm group, respectively."||mmHg|Participants|Standard Deviation|Mean
667886|NCT01733732|Secondary|Mean Change From Baseline in Dry Eye Status as Measured by the Schirmer's Test by Visit|Dry eye status was assessed using the Schirmer’s test. The investigator placed a paper strip on the eye under the lower lid for a specified time period. The length of the strip wetted by the tears was measured in millimeters. Baseline-adjusted values were tabulated; a positive number change from baseline indicates an improvement. Each eye was assessed individually. Both eyes contributed to the mean.|Baseline (Day 0), Day 14, Day 30|"This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. Here, n is the number of eyes with non-missing values at the specific time point for each arm group, respectively."||millimeters|Participants|Standard Deviation|Mean
667887|NCT01733732|Secondary|Mean Change From Baseline mRNA for % HLA-DR and TNF-alpha Gene Expression at Day 30|Conjunctival samples were collected by Impression Cytology (IC) and analyzed in a lab. Total RNA was isolated. The number of cells expressing the inflammatory marker (as a percentage of total cells) was calculated. Baseline-adjusted scores were calculated as score at Day 30 minus score at baseline. A negative baseline-adjusted value indicates an improvement. Each eye was assessed individually. Both eyes were included in the mean.|Baseline (Day 0), Day 30|"This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. Here, n is the number of subjects with non-missing values at the specific time point for each arm group, respectively."||percentage of cells||Standard Deviation|Mean
667888|NCT01733732|Secondary|Mean Change From Baseline for % HLA-DR Inflammatory Biomarker Expression at Day 30|Conjunctival samples were collected by Impression Cytology (IC) and analyzed in a lab. The number of cells expressing the inflammatory marker HLA-DR (as a percentage of total cells) was calculated. Baseline-adjusted scores were calculated as HLA-DR score at Day 30 minus HLA-DR score at baseline. A negative baseline-adjusted value indicates an improvement. Each eye was assessed individually. Both eyes were included in the mean.|Baseline (Day 0), Day 30|This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit.||percentage of cells|Participants|Standard Deviation|Mean
667889|NCT01733732|Secondary|Mean Change From Baseline in Tear Inflammatory Cytokine Expression at Day 30|A tear sample was collected and cytokine (small proteins) levels were analyzed using a High Sensitive Human Cytokine MilliPlex kit and measured in picograms/milliliter (pg/mL). Baseline-adjusted scores were tabulated; a negative number change from baseline indicates improvement. Each eye was assessed individually. Both eyes contributed to the mean.|Baseline (Day 0), Day 30|"This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. Here, n is the number of subjects with non-missing values at the specific time point for each arm group, respectively."||pg/mL||Standard Deviation|Mean
667890|NCT01733732|Secondary|Mean Change From Baseline in Ocular Surface Staining by Visit|Ocular surface staining (damage to the ocular surface) was assessed using non-toxic ophthalmic dye during slit-lamp review. Corneal and conjunctival staining were graded as per the National Eye Institute (NEI) pictorial scale. The ocular staining score ranges from 0 to 3. The lower the score, the less signs of dry eye disease a patient exhibits. Baseline-adjusted scores were tabulated; a negative number change from baseline indicates an improvement. Each eye was assessed individually. Both eyes contributed to the mean.|Baseline (Day 0), Day 14, Day 30|This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. The actual sample size used in calculating the outcome measure may be smaller due to missing responses and/or visit attendance.||units on a scale|Participants|Standard Deviation|Mean
667891|NCT01733732|Secondary|Mean Change From Baseline in Tear Meniscus Height (TMH) by Visit|TMH (the distance between the line of reflection along the top of the tear prism to the edge of the eyelid) was measured in millimeters using the Oculus keratograph 5M. Baseline-adjusted scores were tabulated; a positive number change from baseline indicates improvement. Each eye was assessed individually. Both eyes contributed to the mean.|Baseline (Day 0), Day 14, Day 30|"This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. Here, n is the number of eyes with non-missing values at the specific time point for each arm group, respectively."||millimeters|Participants|Standard Deviation|Mean
667944|NCT01732835|Secondary|LV Systolic Volume - Change From Baseline|Left ventricular systolic volume. Transthoracic echocardiography parameter.|Baseline and 6 months|Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.||ml||Standard Deviation|Mean
667945|NCT01732835|Secondary|LV Diastolic Volume - Change From Baseline|Left ventricular diastolic volume. Transthoracic echocardiography parameter.|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.||ml||Standard Deviation|Mean
667892|NCT01733732|Secondary|Mean Change From Baseline in Non-invasive Keratographic Tear Break up Time (NIKBUT) by Visit|NIKBUT (time required for dry spots to appear on the surface of the eye after blinking) was measured in seconds using the Oculus keratograph 5M. Baseline-adjusted scores were tabulated; a positive number change from baseline indicates improvement. Each eye was assessed individually. Both eyes contributed to the mean.|Baseline (Day 0), Day 14, Day 30|"This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. Here, n is the number of eyes with non-missing values at the specific time point for each arm group, respectively."||seconds|Participants|Standard Deviation|Mean
667893|NCT01733732|Secondary|Meibomian Gland Expression|Meibomian gland expression (ie, pressing on the meibomian glands to excrete oil) was performed by the investigator during undilated slit lamp examination and graded on a 4-point scale where 0=normal, clear oil expressed and 3=congealed or no material expressed. Each eye was assessed individually. Both eyes contributed to the mean.|Baseline (Day 0), Day 14, Day 30|"This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. Here, n is the number of eyes with non-missing values at the specific time point for each arm group, respectively."||units on a scale|Participants|Standard Deviation|Mean
667894|NCT01733732|Secondary|Percentage of Eyes With Normal Slit-lamp Assessment|An undilated slit lamp exam was performed to examine the regions of the eye: orbit/lids, conjunctiva, cornea, anterior chamber, iris and lens. Each region was graded normal or abnormal. The percentage of eyes with normal assessments by region is reported. Each eye was assessed individually. Both eyes were included in the tabulation.|Baseline (Day 0), Day 14, Day 30|This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. The actual sample size used in calculating the outcome measure may be smaller due to missing responses and/or visit attendance.||percentage of eyes|Participants||Number
667895|NCT01733732|Secondary|Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) by Visit|BCVA (with spectacles or other visual corrective devices) was determined using an ETDRS or modified EDTRS chart and measured in logMAR (logarithm of the minimum angle of resolution). Baseline-adjusted logMAR values were tabulated; a negative number change from baseline indicates better visual acuity. Each eye was assessed individually. Both eyes contributed to the mean.|Baseline (Day 0), Day 14, Day 30|"This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. Here, n is the number of eyes with non-missing values at the specific time point for each arm group, respectively."||LogMAR||Standard Deviation|Mean
667896|NCT01733732|Primary|Ocular Comfort Measured as Mean Change From Baseline in OSDI Score by Visit|The Ocular Surface Disease Index (OSDI) is a 12-question validated questionnaire used to measure ocular symptoms, visual function, and environmental factors that may affect a patient's vision. The OSDI scoring scale ranges from 0 to 100. The lower the score, the more symptomatic relief from dry eye symptoms a patient experiences. Baseline-adjusted scores were tabulated; a negative number change from baseline indicates a perceived improvement in ocular comfort.|Baseline (Day 0), Day 14, Day 30|"This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. Here, n is the number of subjects with non-missing values at the specific time point for each arm group, respectively."||units on a scale||Standard Deviation|Mean
667897|NCT01733329|Secondary|Blood Loss||24 hours|||mL||Standard Deviation|Median
667898|NCT01733329|Secondary|Postpartum Hemorrhage|"Defined as:
Estimated blood loss ≥1000 mL after cesarean delivery. A substantial fall in the haematocrit e.g. 10% The requirement for a blood transfusion"|24 HOURS|||percentage of patients|||Number
667899|NCT01733329|Secondary|Uterine Atony|Uterine atony is defined as failure of the uterus to contract adequately following delivery. Recognition of a soft, “boggy” uterus in the setting of excessive postpartum bleeding can alert the attendant to atony and should trigger a series of interventions aimed at achieving tonic sustained uterine contraction.|24 hours|||percentage of participants|||Number
667900|NCT01733329|Primary|Need for Additional Uterotonic Medications|The surgeon requested additional uterotonic agents on the basis of the clinical findings during surgery (e.g. uterine atony or blood loss of at least 1000 mL) Additional oxytocin was considered additional oxytocic intervention for purposes of data analysis.|24 hours|||percentage of participants|||Number
667901|NCT01733316|Secondary|Halitosis Substudy: Expired Air DMS Concentrations|Participants who report halitosis (“bad breath”) as a side effect while receiving Cystagon® will be asked to participate in a substudy that will investigate the concentration of DMS in expired air after the administration of study medication. To assess halitosis during study medication treatment, the steady state PK samples of cysteamine and DMS will be collected over a 6 hour period when Cystagon® is administered and over a 12 hour period when RP103 is administered. Data will be summarized in final analysis.|While taking Cystagon® (Month 1, 2 or 3): Within 15 minutes prior to morning dose 30 min post-dose, 2, 3, 4 and 6 hours post-dose. While taking RP103 (Month 4, 5, or 7): Within 15 min. prior to morning dose. 1, 2, 3, 4, 5, 6, 8, 10, 12 hours post dose||06/2018||||
667902|NCT01733316|Secondary|Halitosis Substudy: Area Under the Plasma Concentration Time Curve (AUC) for Plasma Cysteamine|Participants who report halitosis (“bad breath”) as a side effect while receiving Cystagon® will be asked to participate in a substudy that will investigate the concentration of DMS in expired air after the administration of study medication. To assess halitosis during study medication treatment, the steady state PK samples of cysteamine and DMS will be collected over a 6 hour period when Cystagon® is administered and over a 12 hour period when RP103 is administered. Data will be summarized in final analysis.|While taking Cystagon® (Month 1, 2 or 3): Within 15 minutes prior to morning dose, 30 minutes post-dose, 1, 2, 4 and 6 hours post-dose. While taking RP103 (Month 5, 6, or 7): 30 minutes after morning dose and 1, 2, 3, 4, 6, 8, 10, 12 hours post-dose||06/2018||||
667903|NCT01733316|Secondary|Halitosis Substudy: Time to Cmax (Tmax) for Plasma Cysteamine|Participants who report halitosis (“bad breath”) as a side effect while receiving Cystagon® will be asked to participate in a substudy that will investigate the concentration of dimethylsulfide (DMS) in expired air after the administration of study medication. To assess halitosis during study medication treatment, the steady state pharmacokinetic (PK) samples of cysteamine and DMS will be collected over a 6 hour period when Cystagon® is administered and over a 12 hour period when RP103 is administered. Data will be summarized in final analysis.|While taking Cystagon® (Month 1, 2 or 3): Within 15 minutes prior to morning dose, 30 minutes post-dose, 1, 2, 4 and 6 hours post-dose. While taking RP103 (Month 5, 6, or 7): 30 minutes after morning dose and 1, 2, 3, 4, 6, 8, 10, 12 hours post-dose||06/2018||||
667904|NCT01733316|Secondary|Halitosis Substudy: Maximum Plasma Concentration (Cmax) for Plasma Cysteamine|Participants who report halitosis (“bad breath”) as a side effect while receiving Cystagon® will be asked to participate in a substudy that will investigate the concentration of dimethylsulfide (DMS) in expired air after the administration of study medication. To assess halitosis during study medication treatment, the steady state pharmacokinetic (PK) samples of cysteamine and DMS will be collected over a 6 hour period when Cystagon® is administered and over a 12 hour period when RP103 is administered. Data will be summarized in final analysis.|While taking Cystagon® (Month 1, 2 or 3): Within 15 minutes prior to morning dose, 30 minutes post-dose, 1, 2, 4 and 6 hours post-dose. While taking RP103 (Month 5, 6, or 7): 30 minutes after morning dose and 1, 2, 3, 4, 6, 8, 10, 12 hours post-dose||06/2018||||
667905|NCT01733316|Secondary|Number of Participants With Physical Examination Findings Reported as AEs Related to Study Drug|The physical examinations included assessments of the following: general appearance, eyes, ears, nose and throat, chest (heart, lungs), abdomen (palpation, gastrointestinal sounds), extremities and skin. The Investigator also conducted a basic neurological examination. Findings were evaluated for treatment-related AEs over the course of the study. Observations from Day 1 Cystagon® dosing up to the first dose of RP103 were attributed to the Cystagon® Phase; those on or after the first dose of RP103 up to Month 7 or study termination visit (which ever occurred first) were attributed to the RP103 Phase. All observations on or after the Month 7 visit through study termination were attributed to the Long-Term RP103 Phase.|Day 1 through interim data cutoff (of 10 April 2015). Median duration of exposure was 91 days (range 82-108) for Cystagon® phase, 119 days (range 98-137) for the RP103 phase, and 168 days (range 1-511) during the long-term RP-103 phase.|Safety Analysis Set: all participants who received at least 1 dose of study drug (RP103).||Participants|||Count of Participants
667906|NCT01733316|Secondary|Number of Participants With Clinically Relevant Trends or Mean Changes From Baseline in Vital Signs|Vital signs (including body mass index, body surface area, weight, systolic blood pressure, diastolic blood pressure, pulse and respiratory rates) over the course of the study were evaluated for clinically relevant trends or changes over the course of the study. Observations from Day 1 Cystagon® dosing up to the first dose of RP103 were attributed to the Cystagon® Phase; those on or after the first dose of RP103 up to Month 7 or study termination visit (which ever occurred first) were attributed to the RP103 Phase. All observations on or after the Month 7 visit through study termination were attributed to the Long-Term RP103 Phase.|Day 1 through interim data cutoff (of 10 April 2015). Median duration of exposure was 91 days (range 82-108) for Cystagon® phase, 119 days (range 98-137) for the RP103 phase, and 168 days (range 1-511) during the long-term RP-103 phase.|Safety Analysis Set: all participants who received at least 1 dose of study drug (RP103).||Participants|||Count of Participants
667907|NCT01733316|Secondary|Number of Participants With Electrocardiogram (ECG) Abnormalities Classified as Clinically Significant|Standard 12-lead ECGs were used for the ECG evaluation. Abnormal ECGs considered clinically significant by the Investigator are reported. Observations from Day 1 Cystagon® dosing up to the first dose of RP103 were attributed to the Cystagon® Phase; those on or after the first dose of RP103 up to Month 7 or study termination visit (which ever occurred first) were attributed to the RP103 Phase. All observations on or after the Month 7 visit through study termination were attributed to the Long-Term RP103 Phase.|Day 1 through interim data cutoff (of 10 April 2015). Median duration of exposure was 91 days (range 82-108) for Cystagon® phase, 119 days (range 98-137) for the RP103 phase, and 168 days (range 1-511) during the long-term RP-103 phase.|Safety Analysis Set: all participants who received at least 1 dose of study drug (RP103).||Participants|||Count of Participants
667908|NCT01733316|Secondary|Number of Participants With Clinical Laboratory Abnormalities (Hematology, Blood Chemistry, Urinalysis) Reported as AEs|Investigators monitored clinical laboratory test findings. If any laboratory test on or after the first study drug treatment was abnormal, it was followed at the discretion of the Investigator. Abnormal laboratory tests considered clinically significant were reported as AEs. Observations from Day 1 Cystagon® dosing up to the first dose of RP103 were attributed to the Cystagon® Phase; those on or after the first dose of RP103 up to Month 7 or study termination visit (which ever occurred first) were attributed to the RP103 Phase. All observations on or after the Month 7 visit through study termination were attributed to the Long-Term RP103 Phase.|Day 1 through interim data cutoff (of 10 April 2015). Median duration of exposure was 91 days (range 82-108) for Cystagon® phase, 119 days (range 98-137) for the RP103 phase, and 168 days (range 1-511) during the long-term RP-103 phase.|Safety Analysis Set: all participants who received at least 1 dose of study drug (RP103).||Participants|||Count of Participants
667909|NCT01733316|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs|AE: any untoward medical occurrence that does not necessarily have a causal relationship with study drug. SAE: any untoward medical occurrence that at any dose: results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is a congenital anomaly or birth defect; or is medically significant, and though not included in the above list, is an important medical event, according to the Investigator. Treatment-emergent adverse events (TEAEs) occurred after first dose of study drug. Observations from Day 1 Cystagon® dosing up to the first dose of RP103 were attributed to the Cystagon® Phase; those on or after the first dose of RP103 up to Month 7 or study termination visit (which ever occurred first) were attributed to the RP103 Phase. All observations on or after the Month 7 visit through study termination were attributed to the Long-Term RP103 Phase.|Day 1 through interim data cutoff (of 10 April 2015). Median duration of exposure was 91 days (range 82-108) for Cystagon® phase, 119 days (range 98-137) for the RP103 phase, and 168 days (range 1-511) during the long-term RP-103 phase.|"Safety Analysis Set: all participants who received at least 1 dose of study drug (RP103). The row At least 1 TEAE includes both serious and non-serious AEs."||Participants|||Count of Participants
667946|NCT01732835|Secondary|LV Diastolic Volume - Change From Baseline|Left ventricular diastolic volume. Transthoracic echocardiography parameter.|Baseline and 6 months|Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.||ml||Standard Deviation|Mean
667947|NCT01732835|Secondary|LVID Systole - Change From Baseline|Left ventricular internal dimension. Transthoracic echocardiography parameter.|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.||cm||Standard Deviation|Mean
667910|NCT01733316|Primary|Average Difference Between Morning and Non-Morning Log WBC Cystine Values|The primary analysis of WBC cystine was performed using the natural log transformed WBC cystine level; the log transformation is a normalizing transformation. For each participant, the difference between the morning and corresponding non-morning log WBC cystine value (non-morning minus morning) at each monthly visit during the Cystagon® phase (Months 1, 2, and 3) was computed and these differences were averaged. The average difference between morning and non-morning log WBC cystine value was similarly computed for each participant during the RP103 phase (Months 5, 6, and 7). The primary analysis compared within-subject pairs (Cystagon® phase paired with RP103 phase) of non-morning minus morning average differences of log WBC cystine level.|While taking Cystagon® (Months 1, 2, 3): within 15 minutes pre-AM and pre-non AM dose. During 3 months of RP103 (Months 5, 6, 7): 30 minutes post-AM and post-PM dose.|Only participants with an average difference during both the Cystagon® and RP103 phases were included.||log [nmol ½ cystine/mg protein]||Standard Deviation|Mean
667911|NCT01733277|Other Pre-specified|Correlation Between the Presence of Neuropathic Pain and Biological Marker of Inflammation (CRP)||Baseline|||mg/L||Standard Deviation|Mean
667912|NCT01733277|Secondary|Variation in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Scores (Total, Pain, Function, Stiffness) and the Presence or Absence of Neuropathic Pain|The WOMAC measures pain (score range 0–20), stiffness (score range 0–8), and functional limitation (score range 0–68) for a Total (cumulative score range 0-96) where the higher the score the worst the pain.|Baseline|||units on a scale||Standard Deviation|Mean
667913|NCT01733277|Primary|Osteoarthritis Structural Changes Assessed by Quantitative Magnetic Resonance Imaging With and Without Neuropathic Pain||Baseline|Number of participant analyzed Per-protocol||participants|||Number
667914|NCT01732263|Primary|Volume of Distribution (Vz/F) of SSP-004184|The distribution of a medication between plasma and the rest of the body.|Over 96 hours post-dose|Pharmacokinetic Analysis Set consists of all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Analysis Set consists of all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||L/kg||Standard Deviation|Mean
667915|NCT01732263|Primary|Total Body Clearance (CL/F) of SSP-004184|The rate at which a drug is removed from the body.|Over 96 hours post-dose|Pharmacokinetic Analysis Set consists of all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Analysis Set consists of all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||L/h/kg||Standard Deviation|Mean
667916|NCT01732263|Primary|Plasma Half-Life (T 1/2) of SSP-004184|The time it takes for the blood plasma concentration of a substance to halve.|Over 96 hours post-dose|Pharmacokinetic Analysis Set consists of all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Analysis Set consists of all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||hours||Standard Deviation|Mean
667917|NCT01732263|Primary|Time of Maximum Plasma Concentration (Tmax) for SSP-004184|Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached.|Over 96 hours post-dose|Pharmacokinetic Analysis Set consists of all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Analysis Set consists of all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||hours||Full Range|Median
667918|NCT01732263|Primary|Maximum Plasma Concentration (Cmax) of SSP-004184|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Over 96 hours post-dose|Pharmacokinetic Analysis Set consists of all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Analysis Set consists of all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||ng/ml||Standard Deviation|Mean
667919|NCT01732263|Primary|Area Under the Plasma Concentration-time Curve (AUC) of SSP-004184|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Over 96 hours post-dose|Pharmacokinetic Analysis Set consists of all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Analysis Set consists of all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||ng*h/ml||Standard Deviation|Mean
667920|NCT01733121|Secondary|Clinical Global Impression - Global Improvement of TD (CGI-TD) at Week 6|Clinician's perspective of the participant's overall improvement of TD symptoms over time. The CGI-TD is based on a 7-point scale (range: 1=very much improved to 7=very much worse).|Week 6|Intent to Treat (ITT) analysis set (all subjects in the safety analysis set with an evaluable, blinded, central video raters’ AIMS dyskinesia total score change from baseline value at one or more scheduled assessment times during the double-blind treatment period)||units on a scale||95% Confidence Interval|Least Squares Mean
667921|NCT01733121|Secondary|AIMS Dyskinesia Total Score Change From Baseline at Week 6|The AIMS Total Dyskinesia Score rates a total of 7 items, rating involuntary movement from 0 (no dyskinesia) to 4 (severe dyskinesia). Items 1 through 7 include facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). The AIMS dyskinesia total score for Items 1-7 ranges from 0 to 28; a higher score reflects increased severity.|Week 6|Intent to Treat (ITT) analysis set (all subjects in the safety analysis set with an evaluable, blinded, central video raters' AIMS dyskinesia total score change from baseline value at one or more scheduled assessment times during the double-blind treatment period)||units on a scale||95% Confidence Interval|Least Squares Mean
667922|NCT01733121|Secondary|Clinical Global Impression - Global Improvement of TD (CGI-TD) at Week 6|Clinician's perspective of the participant's overall improvement of TD symptoms over time. The CGI-TD is based on a 7-point scale (range: 1=very much improved to 7=very much worse).|Week 6|Per protocol analysis set (subjects in the ITT analysis set that had an evaluable, blinded, central video raters' AIMS dyskinesia total score change from baseline value at Week 6, had a quantifiable NBI-98782 plasma concentration at Week 6 [for subjects in the NBI-98854 group], and had no efficacy-related important protocol deviations)||units on a scale||95% Confidence Interval|Least Squares Mean
667923|NCT01733121|Primary|Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score Change From Baseline at Week 6|The AIMS Total Dyskinesia Score rates a total of 7 items, rating involuntary movement from 0 (no dyskinesia) to 4 (severe dyskinesia). Items 1 through 7 include facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). The AIMS dyskinesia total score for Items 1-7 ranges from 0 to 28; a higher score reflects increased severity.|Baseline and Week 6|Per protocol analysis set (subjects in the ITT analysis set that had an evaluable, blinded, central video raters’ AIMS dyskinesia total score change from baseline value at Week 6, had a quantifiable NBI-98782 plasma concentration at Week 6 [for subjects in the NBI-98854 group], and had no efficacy-related important protocol deviations)||units on a scale||Standard Error|Least Squares Mean
667924|NCT01733069|Primary|APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type|Count of participants having a positive or negative APTIMA Combo 2 assay result (sensitivity and specificity)|Baseline|Results for 4 gender-specific sample types were reported for 2 targets (CT, Chlamydia trachomatis; and GC, Neisseria gonorrhoeae infection). In this observational study, 1313 females (143 CT and/or GC-infected) and 549 males (121 CT and/or GC infected) contributed to one or more analyses.||participants|||Number
667925|NCT01733056|Primary|Influenza Hemagluttination Inhibition Titers Measured Against Pandemic H1N1 Strains Before and After Influenza Vaccination|Influenza hemagluttination inhibition titers were measured against pandemic H1N1 strains before and after influenza vaccination. Titers greater than or equal to 1:40 constitute a protective response to influenza strains.|28 days|||participants|||Number
667926|NCT01733056|Primary|Influenza Hemagluttination Inhibition Titers Measured Against H3N2 Perth Before and After Influenza Vaccination|Influenza hemagluttination inhibition titers were measured against H3N2 Perth before and after influenza vaccination. Titers greater than or equal to 1:40 constitute a protective response to influenza strains.|28 days|||participants|||Number
667927|NCT01732926|Secondary|Overall Survival (OS)|Overall survival is defined as the interval from randomization to death from any cause.||Due to the early termination of the study, efficacy data were not mature for all participants, and therefore the prespecified analyses were not conducted.|||||
667928|NCT01732926|Secondary|Lymph Node Response Rate|Lymph node response rate is defined as the proportion of participants who achieve ≥ 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters of index lesions. Lymph node response rate was to be assessed by an IRC.||Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.|||||
667929|NCT01732926|Secondary|Overall Response Rate (ORR)|Overall response rate is defined as the proportion of participants who achieve a complete response or partial response (or very good partial response (VGPR) or minor response (MR) for participants with Waldenstrom's). ORR was to be assessed by an IRC.||Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.|||||
667930|NCT01732926|Secondary|Complete Response Rate (CR)|Complete response rate is defined as the proportion of participants who achieve a complete response. CR rate was to be assessed by an IRC.||Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.|||||
667931|NCT01732926|Primary|Progression-free Survival (PFS)|PFS is defined as the interval from randomization to the earlier of the first documentation of definitive indolent non-Hodgkin lymphomas (iNHL) disease progression or death from any cause. Definitive iNHL disease progression is progression based on standard criteria. PFS was to be assessed by an independent review committee (IRC).||Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.|||||
667932|NCT01732913|Secondary|Overall Survival|Overall survival is defined as the interval from randomization to death from any cause.||Due to the early termination of the study, efficacy data were not mature for all participants, and therefore the prespecified analyses were not conducted.|||||
667933|NCT01732913|Secondary|Complete Response Rate|Complete response rate is defined as the proportion of participants who achieve a complete response. Complete response rate was to be assessed by an IRC.||Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.|||||
667934|NCT01732913|Secondary|Lymph Node Response Rate|Lymph node response rate is defined as the proportion of participants who achieve ≥ 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters of index lesions. Lymph node response rate was to be assessed by an IRC.||Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.|||||
667935|NCT01732913|Secondary|Overall Response Rate|Overall Response Rate (ORR) is defined as the proportion of participants who achieve a complete response or partial response (or very good partial response or minor response for participants with Waldenstrom's). ORR was to be assessed by an IRC.||Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.|||||
667936|NCT01732913|Primary|Progression Free Survival|Progression-free survival (PFS) is defined as the interval from randomization to the earlier of the first documentation of definitive indolent non-Hodgkin lymphoma (iNHL) disease progression or death from any cause. PFS was to be assessed by an independent review committee (IRC).||Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.|||||
667937|NCT01732835|Secondary|Cardiac Index - Change From Baseline|Hemodynamic parameter computed as cardiac output divided by body surface area|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.||l/min/m^2||Standard Deviation|Mean
667938|NCT01732835|Secondary|Cardiac Index - Change From Baseline|Hemodynamic parameter computed as cardiac output divided by body surface area|Baseline and 6 months|Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.||l/min/m^2||Standard Deviation|Mean
667939|NCT01732835|Secondary|Cardiac Output - Change From Baseline|Stroke volume x heart rate. Transthoracic echocardiography parameter.|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.||l/min||Standard Deviation|Mean
667957|NCT01732835|Secondary|New York Heart Association (NYHA) Functional Capacity Classification at 2 Years|Four classes describing the effect of cardiac disease on physical activity: Class I - disease does not limit activity; Class II - slight limitation; Class III - marked limitation; Class IV - inability to carry out any physical activity without discomfort|2 years|Participants with an evaluation of this measure.||participants|||Number
667958|NCT01732835|Secondary|New York Heart Association (NYHA) Functional Capacity Classification at 6 Months|Four classes describing the effect of cardiac disease on physical activity: Class I - disease does not limit activity; Class II - slight limitation; Class III - marked limitation; Class IV - inability to carry out any physical activity without discomfort|6 months|Participants with an evaluation of this measure.||participants|||Number
667959|NCT01732835|Secondary|Aortic Insufficiency (AI) at 2 Years|Assessed by transthoracic echocardiography (TTE) and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+)|2 years|Participants with an echocardiogram evaluable for this measure.||participants|||Number
667960|NCT01732835|Secondary|Survival Defined as Survival Free From All Cause Death at 2 Years Postprocedure||2 years|||percentage of participants||95% Confidence Interval|Number
667961|NCT01732835|Secondary|Actuarial Freedom From Clinical Cardiovascular Events|Freedom from specified clinical cardiovascular events at 6 months postprocedure: - Device-related mortality - Complete heart block - Structural device failure - Endocarditis - Periprosthetic leak or dehiscence - Thromboembolism - Bleeding Event - Native Valve Deterioration - Valve Thrombosis - Hemolysis - Reoperation and explant at 6 months|6 months|||percentage of participants||95% Confidence Interval|Number
667962|NCT01732835|Secondary|Implant Procedure Success|Success is defined as the absence of specified adverse events evaluated through discharge or 14 days after the procedure: - Aortic annular dissection, rupture, or leaflet damage - Mitral valve impingement due to implant - implant dehiscence/migration into aorta - implant dehiscence/migration into left ventricle - Hemodynamics requiring intervention - Other adverse event resulting in reoperation, explantation, or permanent disability.|discharge or 14 days postprocedure, whichever comes first|||percentage of implant procedures||95% Confidence Interval|Number
667963|NCT01732835|Primary|Primary Efficacy Outcome Measure: Aortic Insufficiency (AI) at 6 Months|Assessed by transthoracic echocardiography (TTE) and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+)|6 months|Participants with an echocardiogram evaluable for this measure.||participants|||Number
667964|NCT01732835|Primary|Primary Safety Outcome Measure: Survival Defined as Survival Free From All Cause Death at 6 Months Postprocedure||6 months|||percentage of participants||95% Confidence Interval|Number
667965|NCT01732796|Secondary|SVR24|Sustained Virologic Response rates across treatment arms at Week 24 post-treatment (SVR24).|24 Week (post-treatment)|FAS||Percantage of participants|||Number
667966|NCT01732796|Secondary|SVR4|Sustained Virologic Response rates across treatment arms at Week 4 post-treatment (SVR4).|4 Week (post-treatment)|FAS||Percentage of participants|||Number
667967|NCT01732796|Primary|Comparisons of SVR12 Rates Across Treatment Arms|Sustained Virologic Response rates across treatment arms at Week 12 post-treatment (SVR12). This is the secondary analyses of the primary endpoint.|12 Week (post-treatment)|FAS||Percentage of participants|||Number
667968|NCT01732796|Primary|SVR12 Rates With Historical Control|Sustained Virologic Response at Week 12 post-treatment (SVR12): Plasma Hepatitis C Virus ribonucleic acid (HCV RNA) level <25 international units/millilitre (IU/mL) at 12 weeks after End of Treatment (EoT). SVR12, was assessed based on the observed HCV RNA result taken at least 10 weeks after treatment discontinuation. This definition was also applied to patients who discontinued treatment early: if the patient had HCV RNA undetected at least 10 weeks after stopping all treatment, they were considered a responder in the primary analysis. This is the primary analyses of the primary endpoint|12 Week (post-treatment)|The primary analyses of efficacy were carried out on an intent-to-treat basis including all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication (FAS).||Percentage of participants|||Number
667969|NCT01732770|Secondary|Percent Change From Baseline in Total Hip BMD at Month 12 - Superiority Analysis||Baseline and Month 12|The primary efficacy analysis set; any postbaseline BMD value obtained at the early termination visit was carried forward as the month 12 value (ie, LOCF).||percent change||95% Confidence Interval|Least Squares Mean
667970|NCT01732770|Secondary|Percent Change From Baseline in Lumbar Spine BMD at Month 12 - Superiority Analysis||Baseline and Month 12|The primary efficacy analysis set; any postbaseline BMD value obtained at the early termination visit was carried forward as the month 12 value (ie, LOCF).||percent change||95% Confidence Interval|Least Squares Mean
667971|NCT01732770|Secondary|Percent Change From Baseline in Total Hip BMD at Month 12 - Non-inferiority Analysis|BMD of the hip was measured by DXA. DXA scans were analyzed by a central imaging facility.|Baseline and Month 12|The primary efficacy analysis set; any postbaseline BMD value obtained at the early termination visit was carried forward as the month 12 value (ie, LOCF).||percent change||95% Confidence Interval|Least Squares Mean
667972|NCT01732770|Primary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 12 - Non-inferiority Analysis|Bone mineral density (BMD) of the lumbar spine was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging facility.|Baseline and Month 12|The primary efficacy analysis set includes all randomized participants who have a baseline BMD measurement and at least one postbaseline BMD measurement. Any postbaseline BMD value obtained at the early termination visit was carried forward as the month 12 value (ie, last observation carried forward [LOCF]).||percent change||95% Confidence Interval|Least Squares Mean
667973|NCT01732757|Secondary|Tearing Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 0|Tearing is evaluated by the subject at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Subjects score tearing on a 5-point numeric analog scale ranging from 0=None/Normal to 4=Very Severe. For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less tearing.|Day 0|All randomized subjects with data at this time point||Scores on a Scale||Standard Deviation|Mean
667974|NCT01732757|Secondary|Eyelid Swelling Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 0|Eyelid swelling is evaluated by the subject at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Subjects score eyelid swelling on a 4-point numeric analog scale ranging from 0=None to 3=Severe. For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less lid swelling.|Day 0|All randomized subjects with data at this time point||Scores on a Scale||Standard Deviation|Mean
667975|NCT01732757|Secondary|Chemosis Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0|Chemosis is swelling of the tissue that lines the eyelids and surface of the eye. Chemosis is evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Investigators score chemosis on a 9-point numeric analog scale ranging from 0=None to 4=Severe (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less chemosis.|Day 0|All randomized subjects with data at this time point||Scores on a Scale||Standard Deviation|Mean
667976|NCT01732757|Secondary|Episcleral Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0|The episclera is the tissue that lies over the white part of the eye. Episcleral redness is evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Investigators score episcleral redness on a 9-point numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less episcleral redness.|Day 0|All randomized subjects with data at this time point||Scores on a Scale||Standard Deviation|Mean
667977|NCT01732757|Secondary|Ciliary Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0|Ciliary redness is redness spreading out around the cornea of the eye. Ciliary redness is evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Investigators score ciliary redness on a 9-point numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less ciliary redness.|Day 0|All randomized subjects with data at this time point||Scores on a Scale||Standard Deviation|Mean
667978|NCT01732757|Secondary|Conjunctival Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0|The conjunctiva is a thin membrane that covers the inner surface of the eyelid and the white part of the eye. Conjunctival redness is evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Investigators score conjunctival redness on a 9-point numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less conjunctival redness.|Day 0|All randomized subjects with data at this time point||Scores on a Scale||Standard Deviation|Mean
667979|NCT01732757|Secondary|Percentage of Subject Eyes in Each Category of the Itching Score Distribution Post Challenge on Day 0|Ocular itching is evaluated by the subject at Hour 16 post challenge on Day 0. Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed).|Day 0|All randomized subjects with data at this time point||Percentage of Subject Eyes|Participants||Number
667980|NCT01732757|Secondary|Percentage of Subjects With a Zero Itch Score at 3, 5, and 7 Minutes Post Challenge on Day 0|Ocular itching is evaluated by the subject at 3, 5, and 7 minutes post challenge on Day 0 (Visit 3B). Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). Zero itch is considered a score = 0.|Day 0|All randomized subjects with data at this time point||Percentage of Subjects|||Number
667981|NCT01732757|Secondary|Percentage of Subjects With Minimal Itching Score at 3, 5, and 7 Minutes Post Challenge on Day 0|Ocular itching is evaluated by the subject at 3, 5, and 7 minutes post challenge on Day 0 (Visit 3B). Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). Minimal itching is considered a score <1.|Day 0|All randomized subjects with data at this time point||Percentage of Subjects|||Number
667982|NCT01732757|Secondary|Ocular Itching Evaluated by the Subject at 5 and 7 Minutes Post Challenge on Day 0|Ocular itching is evaluated by the subject at 5 and 7 minutes post challenge on Day 0 (Visit 3B). Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less itching.|Day 0|All randomized subjects with data at this time point||Scores on a Scale||Standard Deviation|Mean
667983|NCT01732757|Primary|Ocular Itching Evaluated by the Subject 3 Minutes Post Challenge on Day 0|Ocular itching is evaluated by the subject at 3 minutes post challenge on Day 0 (Visit 3B). Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less itching.|Day 0 at 3 Minutes Post Challenge|All randomized subjects with data at this time point||Scores on a Scale||Standard Deviation|Mean
667984|NCT01732692|Secondary|Percentage of Patients Who Experienced Adverse Events (AEs)|An AE was a worsening in severity or frequency of a concomitant illness or any new illness diagnosed during the clinical trial period. A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability / incapacity; is a congenital anomaly / birth defect; is medically important. Severity is a clinical observation and describes the intensity of the event: Mild: Transient symptoms, no interference with daily activities; Moderate: Marked symptoms, moderate interference with daily activities; Severe: Considerable interference with daily activities. Relatedness to study drug was assessed by the Investigator.|From first dose of study drug until the end of colonoscopy procedure, maximum of 24 hours.|Safety population||percentage of participants|||Number
667985|NCT01732692|Secondary|Patient Compliance – Amount of Additional Clear Liquid Consumed|To prevent any potential dehydration risk participants were recommended the intake of at least 500 ml of additional clear liquid (juices without pulp, tea, water) per liter of the Moviprep solution. The amount of additional clear liquid taken is reported for each liter of Moviprep taken.|1 day (the day of colonoscopy)|Intent-to-treat population with available data||ml||Standard Deviation|Mean
667986|NCT01732692|Secondary|Total Compliance Score|"Compliance score = 100 * (total amount MOVIPREP® intake) / (planned MOVIPREP intake).
Total compliance score of MOVIPREP is the average score of the compliance for the first and second litre."|1 day (the day of colonoscopy)|Intent-to-treat with available data||units on a scale||Standard Deviation|Mean
667987|NCT01732692|Secondary|Patient Satisfaction of Colonoscopy Preparation (VAS)|"Patient satisfaction was measured on a 100 mm visual analog scale (VAS) where 0 (left end of the line) is marked as totally unacceptable (lowest patient satisfaction of colonoscopy preparation) and 100 is fully acceptable (highest patient satisfaction with the procedure). Satisfaction was scored based on a mark placed on the line by the participant."|1 day (the day of colonoscopy)|Intent-to-treat population with available VAS data.||units on a scale||Standard Deviation|Mean
667988|NCT01732692|Primary|Percentage of Participants With Successful Colon Cleansing|Bowel cleansing was assessed by a blinded endoscopist through visual evaluation of 5 colon segments and scored using the Harefield Cleansing Scale (HCS): A = success, all segments clean/scored 4 or 3; B = success, ≥1 segment with liquid/semi-solid amounts of stool, fully removable, ≥1 segment scored 2; C = failure, ≥1 segment with semi-solid or solid amounts of stool, at least 1 segment scored 1; and D = failure, ≥ 1 segment with irremovable, heavy, hard stools, ≥ 1 segment scored 0. Segmental evaluation of colon cleansing scores is as follows: 4: Colon empty and clean, no remaining stool or liquid. 3: Presence of clear liquid in the gut which can be removed by suction. 2: Brown liquid or semisolid remaining amounts of stool, fully removable. 1: Semisolid amounts of stool, only partially removable, difficult to make colonoscopy; 0: Irremovable, heavy, hard stools, colonoscopy impossible. Success of cleansing was defined as Grades of bowel cleansing А and В.|1 day (the day of colonoscopy)|Intent-to-treat population||percentage of participants|||Number
667989|NCT01732588|Secondary|OZ439 Tmax|Time of maximum observed plasma drug concentrations (Tmax)|pre dose, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post dose|"PK population included all subjects who received at least 1 dose of IMP and who had sufficient plasma concentration data for PK parameter estimation.
In addition, for Regimen C only subjects in whom the activation was performed successfully at the target site were included for this regimen."||hours||Full Range|Median
667990|NCT01732588|Primary|OZ439 Cmax|The maximum observed plasma drug concentrations (Cmax)|pre dose, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post dose|"PK population included all subjects who received at least 1 dose of IMP and who had sufficient plasma concentration data for PK parameter estimation.
In addition, for Regimen C only subjects in whom the activation was performed successfully at the target site were included for this regimen."||ng/mL||Geometric Coefficient of Variation|Geometric Mean
667991|NCT01732588|Primary|OZ439 AUC0-∞|Area under the plasma concentration-time curve from zero to infinity (AUC0-∞)|pre dose, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post dose|"PK population included all subjects who received at least 1 dose of IMP and who had sufficient plasma concentration data for PK parameter estimation.
In addition, for Regimen C only subjects in whom the activation was performed successfully at the target site were included for this regimen."||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
667992|NCT01732549|Secondary|Safety Profile of Tasquinimod|Number of subjects reporting adverse events|At regular intervals during the study treatment period and every 3 months during the follow-up until death (approximately up to 2.5 years)|Safety Population: All patients who received at least one dose of study treatment. Patients were allocated to the treatment they actually received||participants|||Number
667993|NCT01732549|Secondary|Change From Baseline of EuroQol-5 Dimension QoL Instrument (EQ-5D) VAS Score|"Baseline is defined as last measurement collected prior to the first dose of study drug. End of Study visit (within 14 days of last dose of study treatment)
The EQ-5D, a 5-item scale useful in health resource utilisation and cost comparisons between treatment groups designed for self-completion by patients consists of two pages [EQ-5 descriptive system and EQ Visual Analogue Scale(VAS)]. The EQ-5 descriptive system comprises five dimensions: mobility, self care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, severe problems. The EQ-VAS records the respondent's self-rated health on a vertical VAS. The respondents are asked to mark health status on the day of the interview on a 10cm vertical scale with end points of 0 to100. There are notes at the both ends of the scale that the bottom rate(0) corresponds to the worst health you can imagine, and the highest rate(100) corresponds to the best health you can imagine"|Baseline and End-of-study Visit (approximately up to 2.5 years)|ITT population||Score on scale||Inter-Quartile Range|Median
667994|NCT01732549|Secondary|Time to Deterioration in Functional Assessment of Cancer Therapy – Prostate (FACT-P)|"End of Study visit (within 14 days of last dose of study treatment)
Impact of tasquinimod on health related quality of life (QoL) - Analysis of time to deterioration in FACT-P
The FACT-P measurement system is a validated collection of health related quality of life (HRQOL) questionnaires used to assess HRQOL in men with prostate cancer. It is appropriate for use with patients with any form of cancer and extensions of it have been used and validated in other chronic illness condition. The FACT-P is a self-administered 39-item scale comprising five domains: physical well-being, social/family well-being, functional well-being, emotional well-being and additional concerns. The individual subscale scores range from 0 to a high between 24 and 48 and the total score ranges between 0 and 156, with higher scores representing better Quality of Life (QoL)"|Up to End of Study visit (approximately up to 2.5 years)|ITT population||weeks||90% Confidence Interval|Median
667995|NCT01732549|Secondary|Time to Further Anticancer Treatment for Prostate Cancer|Time from randomisation to further treatment for prostate cancer|Every 3 months after study treatment stop until further anticancer therapy for prostate cancer (approximately up to 2.5 years)|ITT population||weeks||90% Confidence Interval|Median
667996|NCT01732549|Secondary|Symptomatic PFS Based on Number of Subjects Who Had Symptomatic Progression or Death|"Symptomatic PFS is defined as the time from the date of randomisation to the date of symptomatic progression or death due to prostate cancer, whichever occurs first [symptomatic progression as assessed by Brief Pain Inventory (BPI) and analgesic use].
Symptomatic progression was defined by the occurrence of pain with documented disease, skeleton related adverse events.
The median symptomatic PFS for placebo and tasquinimod groups was not reached.
Tasquinimod: Patients censored = 48, Patients at risk (t=0) = 71 Placebo: Patients censored = 54, Patients at risk (t=0) = 73"|Every 8 weeks until symptomatic or radiological progression documentation (approximately up to 2.5 years)|ITT Population||participants|||Number
668023|NCT01732471|Secondary|Percent Change From Baseline in Blood Phenylalanine Levels at Day 8 in Sub-population of Responders|Percent change in blood phenylalanine levels after 8-day Kuvan® therapy (response test period) was calculated as (blood phenylalanine level at Day 8 minus blood phenylalanine level at baseline)*100/ blood phenylalanine level at baseline.|Baseline, Day 8|Sub-population of responders included participants with reduction in blood phenylalanine levels of greater than or equal to 30% at Day 8 as compared to baseline.||percent change||Standard Deviation|Mean
667997|NCT01732549|Secondary|Time to Progression Free Survival [PFS] on Next-line Therapy (PFS 2)|"The time from the date of randomisation to the date of radiological progression free survival [PFS] on next-line therapy (PFS 2) or death due to any cause.
Radiological progression was defined
- Using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for soft tissue lesions (Eisenhauer, EJC 2009), as at least a 20% relative and a 5 mm absolute increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters recorded on study (including Screening or the appearance of one or more new lesions) for target Lesions.
Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
- Using Prostate Cancer Clinical Working Group in March 2008 (PCWG2) criteria for bone lesions (Scher, JCO 2008). Progression was defined as appearance of 2 or more bone lesions."|Every 3 months after study treatment stop (follow-up) until progression under the next line therapy (approximately up to 2.5 years)|ITT Population||weeks||90% Confidence Interval|Median
667998|NCT01732549|Secondary|Overall Survival Based on Number of Subjects Who Died|"Overall survival is defined as the time from randomisation to death due to any cause.
The number of participants who died is presented since the Median was not reached for this assessment.
Tasquinimod: Patients censored = 63, Patients at risk (t=0) = 71 Placebo: Patients censored = 67, Patients at risk (t=0) = 73"|Every 3 months after study treatment stop until death (approximately up to 2.5 years)|ITT Population||participants|||Number
667999|NCT01732549|Primary|Time to Radiological Progression Free Survival [PFS]|"The time from the date of randomisation to the date of radiological progression or death due to any cause.
Radiological progression was defined
- Using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for soft tissue lesions (Eisenhauer, EJC 2009), as at least a 20% relative and a 5 mm absolute increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters recorded on study (including Screening or the appearance of one or more new lesions) for target Lesions.
Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
- Using Prostate Cancer Clinical Working Group in March 2008 (PCWG2) criteria for bone lesions (Scher, JCO 2008). Progression was defined as appearance of 2 or more bone lesions."|Every 8 weeks until disease progression documentation (approximately up to 2.5 years)|Intention to treat (ITT) Population||weeks||90% Confidence Interval|Median
668000|NCT01732510|Secondary|Number of Participants Positive for Anti-Drug Antibody (ADA) Formation|Testing for ADA positivity and neutralizing response and antibody titre quantification are performed with blood (serum) samples collected at baseline (Day 1 predose) and Days 14, 28, 42, 56, 74, 112, and 224. Neutralizing response refers to ADA neutralizing interference with study drug assessed in vitro. Non-Treatment emergent ADA refers to presence of ADAs (as determined by assay) in the absence of treatment with study drug (i.e., at predose).|Days 1 (predose) and Days 14, 28, 42, 56, 74, 112, and 224|The ADA evaluable population defined as all participants with at least one ADA sample available after treatment with MK-8226 or placebo was used for analysis.||Participants|||Number
668001|NCT01732510|Secondary|Percentage of Participants With >=50% Improvement in EASI Score|The EASI assesses intensity of four lesion characteristics (erythema, infiltration/population, excoriation, lichenification) each rated on a scale of 0 (absent) to 3 (severe) across four regions (head, trunk, upper and lower extremities). Affected areas in each region are assessed as percentage of body surface (head [10%], trunk [30%], upper extremities [20%], and lower extremities [40%]). The total score is a sum of each region score and can range from 0 (absent disease) to 72 (severe disease).|Baseline, Week 12, Week 24|No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis. The study was early terminated from a business perspective.|||||
668002|NCT01732510|Other Pre-specified|Change From Baseline in the Participant's Global Impression of Disease Status in Study Part 2|Participant subjective impression of improvement of his/her disease condition is scored on a six-point scale: 0 (Clear) to 5 (Very severe disease).|Baseline, Week 4, Week 12, Week 24|No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis. The study was early terminated from a business perspective.|||||
668003|NCT01732510|Secondary|Number of Participants Requiring As-Needed Oral Antihistamines as Rescue Medication in Study Part 2|Oral antihistamines (i.e., diphenhydramine, acrivastine fenistil) were provided as as-needed rescue medication for severe pruritus.|Up to Week 12|No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis. The study was early terminated from a business perspective.|||||
668004|NCT01732510|Secondary|Change From Baseline in Participant Sleep Disturbance in Study Part 2|Sleep disturbance (sleep loss, disruption, or interference) due to unremitting pruritus and other causes is a quality of life issue in moderate to severe atopic dermatitis. Participant subjective assessment of sleep disturbance (component of SCORAD) over the past 3 days is rated on a VAS ranging from 1 to 10 cm (increasing severity).|Baseline, Week 4, Week 12, Week 24|No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis. The study was early terminated from a business perspective.|||||
668005|NCT01732510|Secondary|Change From Baseline in Participant Pruritus in Study Part 2|Skin pruritus (itching) is a typical characteristic of atopic dermatitis. Participant subjective assessment of pruritus (component of SCORAD) is rated on a VAS ranging from 1 to 10 cm (increasing severity).|Baseline, Week 4, Week 12, Week 24|No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis. The study was early terminated from a business perspective.|||||
668024|NCT01732471|Secondary|Percent Change From Baseline in Blood Phenylalanine Levels at Day 8 in Overall Population|Percent change in blood phenylalanine levels after 8-day Kuvan® therapy (response test period) was calculated as (blood phenylalanine level at Day 8 minus blood phenylalanine level at baseline)*100/ blood phenylalanine level at baseline.|Baseline, Day 8|Overall (ITT) population included all participants who had efficacy assessment result from at least 1 visit except for the inclusion visit.||percent change||Standard Deviation|Mean
668126|NCT01730053|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Non-HDL-C ITT population.||percent change||Standard Error|Least Squares Mean
668006|NCT01732510|Secondary|Change From Baseline in the Scoring Atopic Dermatitis Scale (SCORAD) in Study Part 2|The SCORAD index scale combines 1) intensity of six lesion characteristics (erythema, edema/papulation, oozing/crusts, excoriations, lichenification, dryness) as assessed by the physician on a scale of 0 (absent) to 3 (severe) across four regions (head, trunk, upper and lower extremities) along with 2) subjective symptoms of pruritus and sleep disturbance as reported by the patient on a visual analog scale (VAS) from 1 to 10 cm (increasing severity). Physician assessment of affected areas in each region is made as percentage of body surface (head [10%], trunk [30%], upper extremities [20%], and lower extremities [40%]). The final SCORAD index score, ranging from 0 (absent disease) to 103 (severe disease), is calculated according to the weighted formula: (0.2 x area) + (3.5 x [sum of intensity score for each of the 6 items]) + participant’s subjective score.|Baseline, Week 4, Week 12, Week 24|No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis. The study was early terminated from a business perspective.|||||
668007|NCT01732510|Secondary|Percentage of Participants With an Investigator Global Assessment (IGA) Score of Clear or Almost Clear in Study Part 2|Percentage of participants achieving an IGA of atopic dermatitis of “clear-0” or “almost clear-1”. The IGA is a six-point scale measuring the severity of disease at time of physical examination of the participant by the physician. The IGA is scored 0 (Clear) to 5 (Very severe disease).|Baseline, Week 4, Week 8, Week 12, Week 24|No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis. The study was early terminated from a business perspective.|||||
668008|NCT01732510|Secondary|Change From Baseline in the Eczema Area and Severity Index (EASI) for Study Part 2|The EASI assesses intensity of four lesion characteristics (erythema, infiltration/population, excoriation, lichenification) each rated on a scale of 0 (absent) to 3 (severe) across four regions (head, trunk, upper and lower extremities). Affected areas in each region are assessed as percentage of body surface (head [10%], trunk [30%], upper extremities [20%], and lower extremities [40%]). The total score is a sum of each region score and can range from 0 (absent disease) to 72 (severe disease).|Baseline, Week 4, Week 8, Week 24|No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis. The study was early terminated from a business perspective.|||||
668009|NCT01732510|Secondary|Terminal Half Life (t1/2) of MK-8226 Following Multiple Dose Intravenous Administration|t1/2, the time needed for the concentration of drug to reach half the initial concentration, was determined for the last period of dosing (starting Week 10 [Day 70]) up to the last measurement. MK-8226 was administered on Days 1, 14, 28, 42, 56, and 70. Blood concentrations of MK-8226 were determined on Days 70 (incl. predose), 72, 74, 84, 98, 112, 140, 168, 196, and 224. The placebo group is not included; this endpoint evaluated only the MK-8226 groups. No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis.|Days 70, 72, 74, 84, 98, 112, 140, 168, 196, 224|The PP population defined as all participants compliant with study procedure with data available (t1/2) from at least one treatment was used for analysis.||days||Geometric Coefficient of Variation|Geometric Mean
668010|NCT01732510|Secondary|Volume of Distribution (Vd) of MK-8226 Following Multiple Intravenous Administration|Vd, a theoretical approximation of degree to which the drug distributes in body tissue rather than plasma (higher Vd indicates greater tissue distribution), was determined for the last period of dosing (starting Week 10 [Day 70]) in the treatment period. MK-8226 was administered on Days 1, 14, 28, 42, 56, and 70. Blood concentrations of MK-8226 were determined on Days 70 (incl. predose), 72, 74, 84, 98, 112, 140, 168, 196, and 224. The placebo group is not included; this endpoint evaluated only the MK-8226 groups. No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis.|Days 70, 72, 74, 84, 98, 112, 140, 168, 196, 224|The PP population defined as all participants compliant with study procedure with data available (Vd) from at least one treatment was used for analysis.||mL/kg||Geometric Coefficient of Variation|Geometric Mean
668011|NCT01732510|Secondary|Clearance (CL) of MK-8226 Following Multiple Dose Intravenous Administration|CL, the volume of plasma cleared of drug per unit time, was determined for the last period of dosing (starting Week 10 [Day 70]) in the treatment period. MK-8226 was administered on Days 1, 14, 28, 42, 56, and 70. Blood concentrations of MK-8226 were determined on Days 1 (incl. predose), 3, 5, 9, 14 (incl. predose), 28 (incl. predose), 42 (incl. predose), 56 (incl. predose), 70 (incl. predose), 72, 74, and 84. The placebo group is not included; this endpoint evaluated only the MK-8226 groups. No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis.|Days 1, 3, 5, 9, 14, 28, 42, 56, 70, 72, 74, 84|The PP population defined as all participants compliant with study procedure with data available (CL) from at least one treatment was used for analysis.||mL/day/kg||Geometric Coefficient of Variation|Geometric Mean
668012|NCT01732510|Secondary|Maximum Serum Concentration (Cmax) of MK-8226 Following Multiple Dose Intravenous Administration|Cmax was determined for the first and last periods of MK-8226 dosing. MK-8226 was administered on Days 1, 14, 28, 42, 56, and 70. Blood concentrations of MK-8226 were determined on Days 1 (incl. predose), 3, 5, 9, 14 (incl. predose), 70 (incl. predose), 72, 74, and 84. The placebo group is not included; this endpoint evaluated only the MK-8226 groups. No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis.|Days 1, 3, 5, 9, 14, 70, 72, 74, 84|The PP population defined as all participants compliant with study procedure with data available (Cmax) from at least one treatment was used for analysis.||μg/mL||Geometric Coefficient of Variation|Geometric Mean
668025|NCT01732471|Primary|Percentage of Participants With Response to Kuvan® (Sapropterin Dihydrochloride) Treatment|Response to Kuvan® (sapropterin dihydrochloride) treatment was defined as a reduction in blood phenylalanine levels of greater than or equal to 30% at Day 8 as compared to baseline.|Day 8|Overall (ITT) population included all participants who had efficacy assessment result from at least 1 visit except for the inclusion visit.||percentage of participants||95% Confidence Interval|Number
668253|NCT01729026|Secondary|Clinician-Administered PTSD Scale for DSM-5 (CAPS)|The administration of the CAPS will ensure that participants meet criteria for current PTSD|The CAPS will be administered at the baseline, 3-month, and 6-month follow-ups.||||||
668013|NCT01732510|Secondary|AUC From Time 0 to Last Measurement (AUC0-last) of MK-8226 Following Multiple Intravenous Dose Administration|AUC0-last defined as AUC up to the last measured concentration was determined for the last period of dosing (starting Week 10 [Day 70]) up to the last measurement. MK-8226 was administered on Days 1, 14, 28, 42, 56, and 70. Blood concentrations of MK-8226 were determined on Days 70 (incl. predose), 72, 74, 84, 98, 112, 140, 168, 196, and 224. The placebo group is not included; this endpoint evaluated only the MK-8226 groups. No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis.|Days 70, 72, 74, 84, 98, 112, 140, 168, 196, 224|The PP population defined as all participants compliant with study procedure with data available (AUC0-last) from at least one treatment was used for analysis.||μg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
668014|NCT01732510|Secondary|Area Under the Concentration-time Curve of MK-8226 From Time 0 to Tau (AUC0-tau) Following Multiple Intravenous Dose Administration|AUC(0-tau) defined as AUC from time zero to tau where tau is the dosing interval (312 hours) was determined for the first and last periods of MK-8226 dosing. MK-8226 was administered on Days 1, 14, 28, 42, 56, and 70. Blood concentrations of MK-8226 were determined on Days 1 (incl. predose), 3, 5, 9, 14 (incl. predose), 70 (incl. predose), 72, 74, 84. The placebo group is not included; this endpoint evaluated only the MK-8226 groups. No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis.|Days 1, 3, 5, 9, 14, 70, 72, 74, 84|The Per-Protocol (PP) population defined as all participants compliant with study procedure with data available (AUC0-tau) from at least one treatment was used for analysis.||μg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
668015|NCT01732510|Secondary|Plasma Chemokine (C-C Motif) Ligand 22 (CCL22) Level in Study Part 2|CCL22 is a pro-allergic chemokine that is assessed in human plasma. Levels of CCL22 are increased in allergic disease states.|Baseline, 48 Hours, Week 2, Week 4, Week 12, Week 16|No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis. The study was early terminated from a business perspective.|||||
668016|NCT01732510|Secondary|Plasma Chemokine (C-C Motif) Ligand 17 (CCL17) Level in Study Part 2|CCL17 is a pro-allergic chemokine that is assessed in human plasma. Levels of CCL17 are increased in allergic disease states.|Baseline, 48 Hours, Week 2, Week 4, Week 12, Week 16|No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from Baseline [BL] in EASI) did not demonstrate adequate effect in an interim futility analysis. The study was early terminated from a business perspective.|||||
668017|NCT01732510|Primary|Change From Baseline in the Eczema Area and Severity Index (EASI) for Study Part 1|Reduction from baseline in EASI at Week 12 (interim analysis data). The EASI assesses intensity of four lesion characteristics (erythema, infiltration/population, excoriation, lichenification) each rated on a scale of 0 (absent) to 3 (severe) across four regions (head, trunk, upper and lower extremities). Affected areas in each region are assessed as percentage of body surface (head [10%], trunk [30%], upper extremities [20%], and lower extremities [40%]). The total score is a sum of each region score and can range from 0 (absent disease) to 72 (severe disease).|Baseline, Week 12|The Full Analysis Set (FAS) defined as all randomized subjects who received at least one dose of study treatment with baseline and at least one post-dose assessment (EASI) was used for analysis.||Score on a scale||Standard Deviation|Mean
668018|NCT01732510|Primary|Number of Participants Who Discontinued Study Drug Due to an Adverse Event|An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an AE.|Up to 12 Weeks|The ASaT population defined as all participants who received at least one dose of investigational drug was used for analysis.||participants|||Number
668019|NCT01732510|Primary|Number of Participants Who Experienced at Least One Adverse Event|An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an AE.|Up to 32 Weeks|The All Subjects as Treated (ASaT) population defined as all participants who received at least one dose of investigational drug was used for analysis.||participants|||Number
668020|NCT01732484|Secondary|Percentage of Eyes With Neodymium:Yttrium-aluminium-garnet (Nd:YAG) Capsulotomy|Treatment of PCO in neodymium:yttrium-aluminium-garnet (Nd:YAG) capsulotomy. The frequency of this treatment will be asseseed in percentage values|3 years|||percentage of eyes|Participants||Number
668021|NCT01732484|Primary|Posterior Capsule Opacification (PCO)|PCO = migration of lens epithelial cells behind the IOL optic after cataract surgery; scale 0-10 (0: no PCO; 10: maximum PCO)|3 years|||units on a scale (0-10)||Standard Deviation|Mean
668022|NCT01732471|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) in Overall Safety Population|An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.|Baseline up to Week 11|Overall safety population included all participants who received at least 1 dose of investigational medicinal product.||participants|||Number
668389|NCT01727180|Primary|Visual Analog Scale (VAS)|A visual analog scale (VAS) measuring the general severity of pruritus was reported from 0 to 10 (0 = no pruritus, 10 = worst pruritus imaginable|Once at the entry of the study|||units on a scale||Standard Deviation|Mean
668085|NCT01730378|Secondary|Number of Subjects Any Unsolicited AEs|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 63-day (Days 21-83) post-dose 2 in Prepandrix Group|Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
668086|NCT01730378|Secondary|Number of Subjects Reporting Unsolicted AEs|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 84-day (Days 0-83) post vaccination period|Analysis was performed on the Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
668087|NCT01730378|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 21 days (Day 0-20) post-vaccination period|Analysis was performed on the Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
669656|NCT01709708|Secondary|Migraine Headache Days|Compare change in the number of migraine headache days per month reported in Baseline Period Diary vs. Treatment Period Diary vs. Post-Treatment Period Diary.|Estimated 14 Weeks||||||
668088|NCT01730378|Secondary|Number of Subjects Reporting Any Potential Immune Mediated Diseases (pIMDs).|Potential immune-mediated diseases (pIMDs) were defined as a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|During the entire study period (From Day 0 to Day 182)|Analysis was performed on the Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
668067|NCT01731990|Secondary|High Sensitivity C-reactive Protein (hsCRP) Ratio of 12 Months to Baseline|Least squares mean for ratio of 12 months to baseline was measured from repeated measures mixed effect model with visit, treatment, treatment-by-visit interaction, baseline and the visit-by-baseline interaction as fixed effects.|Baseline, 12 months post-dose|The PD analysis set included all patients with available PD data and no protocol deviations with relevant impact on PD data. Patients with baseline and 12 month data are included in this analysis.||Ratio||Standard Error|Least Squares Mean
668068|NCT01731990|Secondary|Serum Amyloid A (SAA) Level Ratio of 12 Months to Baseline|Least squares mean for ratio of 12 months to baseline was measured from repeated measures mixed effect model with visit, treatment, treatment-by-visit interaction, baseline and the visit-by-baseline interaction as fixed effects.|Baseline, 12 months post-dose|The PD analysis set included all patients with available PD data and no protocol deviations with relevant impact on PD data. Patients with baseline and 12 month data are included in this analysis.||Ratio||Standard Error|Least Squares Mean
668069|NCT01731990|Secondary|Number of Patients With Adverse Events in 12 Months|Summary statistics on adverse event is reported. It is categorized as number of patients in total adverse events (non serious and serious AEs), serious adverse event, death.|Baseline to 12 months post-dose|All patients that received any study drug were included in the safety analysis set.||Participants|||Count of Participants
668089|NCT01730378|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed were fatigue, headache, joint pain, muscle aches, shivering, increased sweating and fever [axillary temperature above 38.0 degrees Celsius (°C)]. Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity as assessed by inability to attend/do work or school, or requires intervention of a physician/healthcare provider. Grade 3 fever = axillary temperature above 39.0°C|During the 7-day (Days 0-6) post-vaccination period|Analysis was performed on the Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
668070|NCT01731990|Primary|Mean Vessel Wall Area Ratio of 12 Months to Baseline|Peripheral artery wall area (superficial femoral artery) measured using Magnetic Resonance Imaging (MRI) cross-section slices. Mean vessel wall area (mm^2) was derived by converting total plaque volume (TPV) (mL) of the vessel to mm^3 by multiplying by 1000, dividing by the number of slices used for the volume calculation, and dividing by the thickness of a slice (3 mm). Least squares mean for ratio of 12 months to baseline was measured from repeated measures mixed effect model with visit, treatment, the treatment-by-visit interaction, baseline and the visit-by-baseline interaction as fixed effects.|Baseline, 12 months post-dose|The pharmacodynamics (PD) analysis set included all patients with available PD data and no protocol deviations with relevant impact on PD data. Patients who underwent iliac/femoral stenting were removed from all data points that occurred after this procedure in the analysis.||Ratio||Standard Error|Least Squares Mean
668071|NCT01731938|Secondary|Treatments Failures|"The following were considered treatment failures:
Persistent bleeding at the TBS beyond T4, Breakthrough (brisk and forceful) bleeding from the TBS that jeopardized subject safety according to the investigator’s judgment at any moment during the 10 minute observational period and until TClosure, Re-bleeding at the TBS after the assessment of the primary efficacy endpoint at T4 and until TClosure Use of alternative hemostatic treatments or maneuvers (other than the study treatment) at the TBS during the 10-minute observational period and until TClosure or use of study treatment at the TBS beyond T4 and until TClosure."|From start of treatment to time of completion of surgical closure.|||percentage of subjects|||Number
668072|NCT01731938|Secondary|Cumulative Proportion of Subjects Achieving Hemostasis at the Target Bleeding Site by 2 (T2), 3 (T3), 5 (T5), 7 (T7), and 10 (T10) Minutes After TStart.||From start of treatment to 2, 3, 5, 7, and 10 minutes after start of treatment|||percentage of subjects|||Number
668073|NCT01731938|Secondary|Time to Hemostasis (TTH)|TTH was measured from the start of treatment to the achievement of hemostasis at the target bleeding site, or to the end of the 10-minute observational period when hemostasis had not yet been achieved.|From start of treatment to the end of the 10-minute observational period|||minutes||Standard Error|Mean
668074|NCT01731938|Primary|Percentage of Subjects Achieving Hemostasis Within 4 Minutes After Treatment Start|Subjects achieving hemostasis at the target bleeding site within 4 minutes following the start of treatment without the occurrence of re-bleeding until the completion of surgical closure.|From start of treatment until 4 minutes after treatment start|||percentage of participants|||Number
668075|NCT01731470|Secondary|Change in Pain Scores at 4 and 8 Weeks Post-Treatment as Measured by the Visual Analog Scale (VAS)|Patients utilized the Visual Analog Scale (VAS) to describe their pain. The scale ranges from 0:No pain to 10: Pain as bad as it could possibly be.|4 and 8 weeks post-treatment|||units on a scale||Inter-Quartile Range|Mean
668076|NCT01731470|Primary|Change in Symptom Severity at 4 and 8 Weeks Post-Treatment as Measured by the Total O'Leary-Sant IC Symptom and Problem Index (ICSI/ICPI) Score|The O’Leary-Sant IC Symptom Index (ICS-I) total score ranges from 0 to 20 and the Problem Index (ICP-I) total score ranges from 0 to 16. Each index has 4 questions and lower scores represent a better outcome. A total ICSI/ICPI score is obtained by adding the total scores from both indices. The combined ICSI/ICPI total score ranges from 0 to 36.|4 and 8 weeks post-treatment|||units on a scale||Inter-Quartile Range|Median
668077|NCT01731119|Secondary|Overall Clinical Improvement|Overall psychiatric functioning will be assessed with the improvement (CGI-I) subscales of the CGI. CGI-I items are rated from 1 (very much improved) to 7 (very much worse).|Baseline to 12 weeks|||units on a scale||Standard Deviation|Mean
668078|NCT01731119|Secondary|Number of Participants Experiencing Side Effects|Assessment of the medication side effects associated with lurasidone (Latuda©) in children and adolescents.|Baseline to12 weeks|||Participants|||Count of Participants
668079|NCT01731119|Secondary|Changes in Efficacy Measures|Efficacy measures included the Aberrant Behavior Checklist-Community (ABC-C) total score which focuses on problem behaviors in five subdomains, including irritability, attention, repetitive behaviors, unusual speech, and social withdrawal. Differences in subdomains were not assessed. The ABC-C total score is the sum of 58 items, each rated among 0 = Not at all; 1 = Slight in degree; 2 = Moderately serious; and 3 = Severe in degree. The ABC-C total score ranges from 0 to 174. Higher values of ABC-C total scores represent greater severity of illness.|Baseline to 12 weeks|||units on a scale||95% Confidence Interval|Mean
668080|NCT01731119|Secondary|Proportion of Participants Completing Treatment|Data will be collected on why participants terminated the study. If terminated early, the specific reason will be collected such as efficacy or tolerability.|12 weeks|||Participants|||Count of Participants
668081|NCT01731119|Primary|Change in Weight|Change in weight from Baseline to Week 12 will be assessed as the primary outcome measure. Subjects will be asked to step on a special scale called a tanita which will calculate weight, fat mass at each study visit.|Baseline to 12 weeks|||lbs||95% Confidence Interval|Mean
668082|NCT01731041|Secondary|P2Y12 Reaction Units (PRU) Determined by VerifyNow P2Y12|Secondary analysis included the differences of platelet reactivity expressed as P2Y12 reaction units (PRU) in each group using the VerifyNow P2Y12 system.|4 hours|||PRU||Standard Error|Least Squares Mean
668083|NCT01731041|Primary|Platelet Reactivity Index (PRI) by Vasodilator-stimulated Phosphoprotein (VASP)|The primary end-point of the study is the comparison in the platelet reactivity index (PRI%) determined by vasodilator-stimulated phosphoprotein (VASP) between baseline and 4-hour after dosing in each arm of treatment|4 hours|||PRI%||Standard Error|Least Squares Mean
668084|NCT01730378|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|A serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|During the entire study period (From Day 0 to 182)|Analysis was performed on the Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
668125|NCT01730053|Secondary|Percent Change From Baseline in Total-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Total-C ITT population.||percent change||Standard Error|Least Squares Mean
668090|NCT01730378|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as significant pain at rest that prevented normal everyday activities as assessed by inability to attend/do work or school. Grade 3 redness and swelling was greater than 100 millimeters (mm) i.e. >100mm.|During the 7-day (Day 0-6) period after each vaccination|Analysis was performed on the Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
668091|NCT01730378|Secondary|Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group.|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Victoria/361/2011 (H3N2) and Flu B/Hubei-Wujiagang/158/2009 (Yamagata).|At Day 0 and Day 21|Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
668092|NCT01730378|Secondary|Mean Geometric Increase (MGI) for HI Antibodies Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group.|MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Victoria/361/2011 (H3N2) and Flu B/Hubei-Wujiagang/158/2009 (Yamagata).|At Day 21|Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Fold increase||95% Confidence Interval|Geometric Mean
668093|NCT01730378|Secondary|Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group.|A seroconverted subjects was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Victoria/361/2011 (H3N2)and Flu B/Hubei-Wujiagang/158/2009 (Yamagata).|At Day 21|Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
668094|NCT01730378|Secondary|Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group.|Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Victoria/361/2011 (H3N2) and Flu B/Hubei-Wujiagang/158/2009 (Yamagata).|At Days 0 and 21|Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Titer||95% Confidence Interval|Geometric Mean
668095|NCT01730378|Secondary|Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.|MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0).|At Day 21|Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Fold increase||95% Confidence Interval|Geometric Mean
668096|NCT01730378|Secondary|Number of Seroconverted Subjects for HI Antibodies Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.|A seroconverted subjects was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.|At Day 21|Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
668097|NCT01730378|Secondary|Number of Subjects Who Were Seroprotected for HI Antibodies Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults.|At Day 0 and Day 21|Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
668098|NCT01730378|Secondary|Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.|Antibody titers were expressed as Geometric mean titers (GMTs).|At Day 21|Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Titer||95% Confidence Interval|Geometric Mean
668099|NCT01730378|Primary|Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.|Antibody titers were expressed as Geometric mean titers (GMTs).|At Day 0 and Day 42|Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Titer||95% Confidence Interval|Geometric Mean
668254|NCT01729026|Primary|Change in PTSD Checklist (PCL-5) Score Between Baseline and 3-month Follow-up|PCL-5 a self rating scale based on the DSM-5 diagnostic criteria. The range of the scale is from 0 (no symptoms) to 80 (maximal symptoms).|Baseline and 3-month follow-up visit.|||units on a scale||Standard Error|Mean
668100|NCT01730378|Primary|Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults.|At Day 42|Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
668101|NCT01730378|Primary|Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.|MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0).|At Day 42|Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Fold increase||95% Confidence Interval|Geometric Mean
668102|NCT01730378|Primary|Number of Seroconverted Subjects for Serum H5N1 Haemagglutination-inhibition (HI) Antibodies Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.|A seroconverted subjects was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.|At Day 42|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.||Subjects|||Number
668103|NCT01730339|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Laboratory Abnormalities|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent adverse event are events between first dose of study drug and up to Week 24 that were absent before treatment or that worsened relative to pre-treatment state. TEAEs related to laboratory abnormalities are reported.|Baseline up to Week 24|Safety population included all participants who received at least 1 dose of investigational product.||participants|||Number
668104|NCT01730339|Other Pre-specified|Number of Participants With Treatment Emergent Adverse Events (AEs) of Special Interest|Treatment Emergent Adverse Events (AEs) of special interest included injection site erythema, maculopapular rash, pruritus, bronchospasm, dyspnea, cough, fever and diarrhea.|Baseline up to Week 24|"Safety population included all participants who received at least 1 dose of investigational product. Here, N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure."||participants|||Number
668105|NCT01730339|Other Pre-specified|Number of Participants With Electrocardiogram Findings|Following parameters were assessed: heart rate, PR Interval, QRS Interval, QT Interval, and Fridericia's Correction Formula (QTcF) interval. Electrocardiogram Results were reported as normal, abnormal, not clinically significant (NCS) and abnormal and clinically significant (CS) as determined by investigator.|Baseline, Week 11|"Safety population included all participants who received at least 1 dose of investigational product. Here, n= participants who were evaluable at given time point for each arm, respectively."||participants|||Number
668106|NCT01730339|Other Pre-specified|Number of Participants With Abnormal Physical Examinations|Physical examination included examination of skin, head, eyes, ears, nose, throat (HEENT), respiratory, cardiovascular, abdomen - liver and kidney, musculoskeletal, gastrointestinal, genitourinary, and neurological systems.|Baseline up to Week 24|Safety population included all participants who received at least 1 dose of investigational product.||participants|||Number
668107|NCT01730339|Other Pre-specified|Number of Participants With Clinically Significant Vital Sign Abnormalities|Vital Sign included pulse rate, systolic blood pressure, diastolic blood pressure, and weight.|Baseline up to Week 24|Safety population included all participants who received at least 1 dose of investigational product.||participants|||Number
668108|NCT01730339|Secondary|Physician and Participant Photoguide Scar Assessment Scale Score|Physician and participants rated severity of each scar using a photonumeric guide on a scale ranging from 1 to 5 (where 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe). Within participant treatment difference was assessed between the treatment regimens each participant received.|Week 8, 11, 18, 24|"mITT population included all participants who were randomized and received at least 1 dose of investigational product. Here, n= participants who were evaluable at given time point for each arm, respectively."||units on scale||Standard Error|Least Squares Mean
668109|NCT01730339|Secondary|Patient-Reported Scar Evaluation Questionnaire (PR-SEQ) Symptoms and Appearance Domains Score|PR-SEQ questionnaire consisted of 30 different attributes of scars that included following four dimensions: appearance (5 attributes), symptoms (3 attributes), bothersomeness (8 attributes), and impacts on the quality of life (physical and emotional wellbeing [14 attributes]). Each question had 5 possible responses: not at all (0), slightly (1), moderately (2), very (3), and extremely (4). Participants completed an abbreviated version which included only the Symptoms and Appearance dimensions to evaluate treatment outcomes. Each of the item scores were transformed into a 0 to 100 scale. Each dimension score was calculated from averaging the transformed scores (0-100 scaled) for specified items. Each domain score ranged from 0 to 100, with higher scores indicating higher severity. Within participant treatment difference was assessed between the treatment regimens each participant received.|Week 8, 24|"mITT population included all participants who were randomized and received at least 1 dose of investigational product. Here,n= participants who were evaluable at given time point for each arm, respectively."||units on scale||Standard Error|Least Squares Mean
668110|NCT01730339|Secondary|Patient Global Assessment Using Overall Opinion of Patient and Observer Scar Assessment Scale (POSAS)|Patient global assessment was performed using the overall opinion question of the POSAS scale. Participants were asked to rate the severity of their scar compared to normal skin. The overall opinion scale score ranged from 1 (normal skin) to 10 (very different from normal skin). Within participant treatment difference was assessed between the treatment regimens each participant received|Week 8, 11, 18, 24|"mITT population included all participants who were randomized and received at least 1 dose of investigational product. Here, n= participants who were evaluable at given time point for each arm, respectively."||units on scale||Standard Error|Least Squares Mean
668111|NCT01730339|Secondary|Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS)|Physician scar assessment was performed using 10-point POSAS scale. Physician rated each of the items (vascularity, pigmentation, thickness, relief, pliability, surface area and overall opinion) for a scar on a score of 1 (normal skin) to 10 (worst scar imaginable). Within participant treatment difference was assessed between the treatment regimens each participant received. Data for overall opinion scale score at Week 24 was not presented in this outcome measure because the data was reported separately under primary outcome measure 1.|Week 8, 11, 18, 24|"mITT population included all participants who were randomized and received at least 1 dose of investigational product. Here,n= participants who were evaluable at given time point for each arm, respectively."||units on scale||Standard Error|Least Squares Mean
668112|NCT01730339|Primary|Physician Global Assessment Using Physician Overall Opinion Question of Patient and Observer Scar Assessment Scale (POSAS)|Physician global assessment was performed using the overall opinion question of the POSAS scale. Physicians were asked to rate the severity of the participant’s scar compared to normal skin. The overall opinion scale score ranged from 1 (normal skin) to 10 (worst imaginable scar). Within participant treatment difference was assessed between the treatment regimens each participant received.|Week 24|Modified Intent To Treat (mITT) population included all participants who were randomized and received at least 1 dose of investigational product. Here, N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||units on scale||Standard Error|Least Squares Mean
668113|NCT01730053|Secondary|Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Apo A-1 ITT population.||percent change||Standard Error|Least Squares Mean
668114|NCT01730053|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Fasting triglycerides ITT population.||percent change||Standard Error|Mean
668115|NCT01730053|Secondary|Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|HDL-C ITT population.||percent change||Standard Error|Least Squares Mean
668116|NCT01730053|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Lipoprotein (a) ITT population.||percent change||Standard Error|Mean
668117|NCT01730053|Secondary|Percent Change From Baseline in Apo A-1 at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline Apo A-1 value on- or off-treatment.||percent change||Standard Error|Least Squares Mean
668118|NCT01730053|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population.||percent change||Standard Error|Mean
668119|NCT01730053|Secondary|Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline HDL-C value on- or off-treatment.||percent change||Standard Error|Least Squares Mean
668120|NCT01730053|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population.||percent change||Standard Error|Mean
668121|NCT01730053|Secondary|Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis|Calculated LDL-C values were obtained from Friedewald formula. Adjusted percentages at Week 24 were obtained from a multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 24 i.e. up to 21 days after last injection or 3 days after the last capsule [whatever rosuvastatin or ezetimibe], whichever came first (on-treatment analysis).|Up to Week 24|mITT population.||percentage of participants|||Number
668122|NCT01730053|Secondary|Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis|Calculated LDL-C values were obtained from Friedewald formula. Adjusted percentages at Week 24 were obtained from a multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to week 24 regardless of status on- or off-treatment were included in the imputation model (ITT analysis).|Up to Week 24|ITT population.||percentage of participants|||Number
668123|NCT01730053|Secondary|Percentage of Very High CV Risk Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - On-Treatment Analysis|Calculated LDL-C values were obtained from Friedewald formula. Adjusted percentages at Week 24 were obtained from a multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 24 i.e. up to 21 days after last injection or 3 days after the last capsule [whatever rosuvastatin or ezetimibe], whichever came first (on-treatment analysis).|Up to Week 24|mITT population.||percentage of participants|||Number
668124|NCT01730053|Secondary|Percentage of Very High CV Risk Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - ITT Analysis|Calculated LDL-C values were obtained from Friedewald formula. Adjusted percentages at Week 24 were obtained from a multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to week 24 regardless of status on- or off-treatment were included in the imputation model (ITT analysis).|Up to Week 24|ITT population.||percentage of participants|||Number
668127|NCT01730053|Secondary|Percent Change From Baseline in Apo B at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Apo B ITT population.||percent change||Standard Error|Least Squares Mean
668128|NCT01730053|Secondary|Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline Total-C value on- or off-treatment.||percent change||Standard Error|Least Squares Mean
668129|NCT01730053|Secondary|Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule [whatever rosuvastatin or ezetimibe], whichever came first).|From Baseline to Week 24|Participants analyzed: participants of the mITT population with one baseline and at least one post-baseline Non-HDL-C value on-treatment.||percent change||Standard Error|Least Squares Mean
668130|NCT01730053|Secondary|Percent Change From Baseline in Non-High-density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment.||percent change||Standard Error|Least Squares Mean
668131|NCT01730053|Secondary|Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (ie. up to 21 days after last injection or 3 days after the last capsule [whatever rosuvastatin or ezetimibe], whichever came first).|From Baseline to Week 24|Participants analyzed: participants of the mITT population with one baseline and at least one post-baseline Apo B value on-treatment.||percent change||Standard Error|Least Squares Mean
668132|NCT01730053|Secondary|Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline Apo B value on- or off-treatment.||percent change||Standard Error|Least Squares Mean
668133|NCT01730053|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis|Calculated LDL-C values were obtained from Friedewald formula. Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule [whatever rosuvastatin or ezetimibe], whichever came first) (on-treatment analysis).|From Baseline to Week 24|mITT population.||percent change||Standard Error|Least Squares Mean
668134|NCT01730053|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis|Calculated LDL-C values were obtained from Friedewald formula. Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment (ITT analysis).|From Baseline to Week 24|ITT population.||percent change||Standard Error|Least Squares Mean
668135|NCT01730053|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis|Calculated LDL-C values were obtained from Friedewald formula. Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (ie. up to 21 days after last injection or 3 days after the last capsule [whatever rosuvastatin or ezetimibe], whichever came first) (on-treatment analysis).|From Baseline to Week 24|Modified ITT (mITT) population: all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.||percent change||Standard Error|Least Squares Mean
668136|NCT01730053|Primary|Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis|Calculated LDL-C values were obtained from Friedewald formula. Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were used in the model (ITT analysis).|From Baseline to Week 24|ITT population: all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment.||percent change||Standard Error|Least Squares Mean
668137|NCT01730040|Secondary|Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Apo A-1 ITT population.||percent change||Standard Error|Least Squares Mean
668138|NCT01730040|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|ITT population.||percent change||Standard Error|Mean
668139|NCT01730040|Secondary|Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|HDL-C ITT population.||percent change||Standard Error|Least Squares Mean
668140|NCT01730040|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Lipoprotein (a) ITT population.||percent change||Standard Error|Mean
668141|NCT01730040|Secondary|Percent Change From Baseline in Apo A-1 at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline Apo A-1 value on- or off-treatment.||percent change||Standard Error|Least Squares Mean
668142|NCT01730040|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|ITT population: all randomized and treated participants with one baseline and at least one post-baseline fasting triglycerides value on- or off-treatment.||percent change||Standard Error|Mean
668143|NCT01730040|Secondary|Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline HDL-C value on- or off-treatment.||percent change||Standard Error|Least Squares Mean
668144|NCT01730040|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population.||percent change||Standard Error|Mean
668145|NCT01730040|Secondary|Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis|Adjusted percentages at Week 24 were obtained from a multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 24 i.e. up to 21 days after last injection or 3 days after the last capsule [whatever atorvastatin, rosuvastatin or ezetimibe], whichever came first (on-treatment analysis).|Up to Week 24|mITT population.||percentage of participants|||Number
668146|NCT01730040|Secondary|Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis|Adjusted percentages at Week 24 were obtained from a multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to week 24 regardless of status on- or off-treatment were included in the imputation model (ITT analysis).|Up to Week 24|ITT population.||percentage of participants|||Number
668147|NCT01730040|Secondary|Percentage of Very High CV Risk Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - On-Treatment Analysis|Adjusted percentages at Week 24 were obtained from a multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 24 i.e. up to 21 days after last injection or 3 days after the last capsule [whatever atorvastatin, rosuvastatin or ezetimibe], whichever came first (on-treatment analysis).|Up to Week 24|mITT population.||percentage of participants|||Number
668148|NCT01730040|Secondary|Percentage of Very High CV Risk Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - ITT Analysis|Adjusted percentages at Week 24 were obtained from a multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to week 24 regardless of status on- or off-treatment were included in the imputation model (ITT analysis).|Up to Week 24|ITT population.||percentage of participants|||Number
668149|NCT01730040|Secondary|Percent Change From Baseline in Total-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Total-C ITT population.||percent change||Standard Error|Least Squares Mean
668150|NCT01730040|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Non-HDL-C ITT population.||percent change||Standard Error|Least Squares Mean
668151|NCT01730040|Secondary|Percent Change From Baseline in Apo B at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Apo B ITT population.||percent change||Standard Error|Least Squares Mean
668152|NCT01730040|Secondary|Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline Total-C value on- or off-treatment.||percent change||Standard Error|Least Squares Mean
668153|NCT01730040|Secondary|Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule [whatever atorvastatin, rosuvastatin or ezetimibe], whichever came first).|From Baseline to Week 24|Participants analyzed: participants of the mITT population with one baseline and at least one post-baseline Non-HDL-C value on-treatment.||percent change||Standard Error|Least Squares Mean
668154|NCT01730040|Secondary|Percent Change From Baseline in Non-High-density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment.||percent change||Standard Error|Least Squares Mean
668155|NCT01730040|Secondary|Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (ie. up to 21 days after last injection or 3 days after the last capsule [whatever atorvastatin, rosuvastatin or ezetimibe], whichever came first).|From Baseline to Week 24|Participants analyzed: participants of the mITT population with one baseline and at least one post-baseline Apo B value on-treatment.||percent change||Standard Error|Least Squares Mean
668156|NCT01730040|Secondary|Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline Apo B value on- or off-treatment.||percent change||Standard Error|Least Squares Mean
668157|NCT01730040|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis|Calculated LDL-C values were obtained from Friedewald formula. Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule [whatever atorvastatin, rosuvastatin or ezetimibe], whichever came first) (on-treatment analysis).|From Baseline to Week 24|mITT population.||percent change||Standard Error|Least Squares Mean
668158|NCT01730040|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis|Calculated LDL-C values were obtained from Friedewald formula. Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment (ITT analysis).|From Baseline to Week 24|ITT population.||percent change||Standard Error|Least Squares Mean
668159|NCT01730040|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis|Calculated LDL-C values were obtained from Friedewald formula. Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule [whatever atorvastatin, rosuvastatin or ezetimibe], whichever came first) (on-treatment analysis).|From Baseline to Week 24|Modified ITT (mITT) population: all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.||percent change||Standard Error|Least Squares Mean
668160|NCT01730040|Primary|Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis|Calculated LDL-C values were obtained from Friedewald formula. Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were used in the model (ITT analysis).|From Baseline to Week 24|ITT population: all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment.||percent change||Standard Error|Least Squares Mean
668161|NCT01729871|Secondary|Number of Participants With Vascular Death|Any death that was not clearly non-vascular. Examples of vascular death included deaths due to bleeding, Myocardial Infarction (MI), stroke, heart failure and arrhythmias.|Up to 30 plus or minus (+-) 5 days after the catheter ablation procedure|Per-protocol analysis set included all randomized participants who took at least 1 dose of study drug and had undergone the catheter ablation procedure.||Participants|||Number
668162|NCT01729871|Secondary|Number of Participants With Non-Central Nervous System (Non-CNS) Systemic Embolism|The Non-CNS systemic embolism was defined as abrupt vascular insufficiency associated with clinical or radiological evidence of arterial occlusion in the absence of other likely mechanisms, (example; trauma, atherosclerosis, instrumentation).|Up to 30 plus or minus (+-) 5 days after the catheter ablation procedure|Per-protocol analysis set included all randomized participants who took at least 1 dose of study drug and had undergone the catheter ablation procedure.||Participants|||Number
668163|NCT01729871|Secondary|Number of Participants With Ischemic Stroke|Stroke was defined as a new, sudden, focal neurological deficit resulting from a presumed cerebrovascular cause that was not reversible within 24 hours and not due to a readily identifiable cause such as a tumor or seizure.|Up to 30 plus or minus (+-) 5 days after the catheter ablation procedure|Per-protocol analysis set included all randomized participants who took at least 1 dose of study drug and had undergone the catheter ablation procedure.||Participants|||Number
668164|NCT01729871|Secondary|Number of Participants With Myocardial Infarction (MI)|The MI was defined as clinical symptoms consistent with myocardial ischemia and cardiac biomarker elevation greater than the site’s upper limit of normal (ULN) or development of new pathological Q waves in at least 2 contiguous leads on the electrocardiogram (ECG) or autopsy confirmation, OR Creatine kinase-muscle and brain subunit [or creatine kinase (CK) in the absence of CK-MB] greater than (>) 3 or 5 or 10 x ULN for samples obtained within 24 hours of the procedure if the baseline values were normal or at least a 50 percent (%) increase over elevated baseline values that were stable or decreasing or development of new pathological Q waves in at least 2 contiguous leads on the electrocardiogram. Symptoms of cardiac ischemia were not required.|Up to 30 plus or minus (+-) 5 days after the catheter ablation procedure|Per-protocol analysis set included all randomized participants who took at least 1 dose of study drug and had undergone the catheter ablation procedure.||Participants|||Number
668165|NCT01729871|Secondary|Number of Participants With Composite Endpoint of Myocardial Infarction (MI), Ischemic Stroke, Non-Central Nervous System (Non-CNS) Systemic Embolism and Vascular Death|The composite endpoint include Myocardial Infarction (MI), Ischemic Stroke, Non-Central Nervous System (non-CNS) Systemic Embolism and Vascular Death.|Up to 30 plus or minus (+-) 5 days after the catheter ablation procedure|Per-protocol analysis set included all randomized participants who took at least 1 dose of study drug and had undergone the catheter ablation procedure.||Participants|||Number
668166|NCT01729871|Primary|Number of Participants With Incidence of Post-Procedure Major Bleeding Events|Post-procedure major bleeding events include Thrombolysis in Myocardial Infarction (TIMI), International Society on Thrombosis and Haemostasis (ISTH) and Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) Severe/life threatening bleeding.|Up to 30 plus or minus (+-) 5 days after the catheter ablation procedure|Per-protocol analysis set included all randomized participants who took at least 1 dose of study drug and had undergone the catheter ablation procedure.||Participants|||Number
668167|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Triacylglycerol Lipase (TL) Enzyme Activity|A triacylglycerol lipase test was done to check for pancreatic function. In the study there were 3 planned safety blood draws for routine blood tests. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to investigational medicinal product administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit, Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.
(Adolescents Group at Visit 3: N=20 one participant with missing data; Older Children N=27 at Visit 1 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data at visit)."||U/L||Standard Deviation|Mean
668255|NCT01728792|Secondary|Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes||Days 28, 90 and 120 after 1st vaccination|Protocol deviations results in testing not performed for outcome measure.|||||
668168|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Alkaline Phosphatase (ALP) Enzyme Activity|The Alkaline Phosphatase activity was used to detect bone or hepatobiliary disease. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit, Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.
(Adolescents Group at Visit 2 and 3: N=20 one participant with missing data; Young and Very Young Children Group at Visits 3: N=16 one participant with missing data at this visit)."||U/L||Standard Deviation|Mean
668169|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Creatine Kinase (CK) Enzyme Activity|The creatine kinase (CK) test was used to detect inflammation of muscles. The test was done in combination with other tests. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit, Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.
(Adolescents Group at Visit 3: N=20 one participant with missing data; Older children at Visit 1: N=27 (1 participant missing); Young and Very Young Children Group at Visit 3: N=16 one participant with missing data at this visit)."||U/L||Standard Deviation|Mean
668170|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Blood Protein Concentration|The test was done to verify kidney and liver function. It is done in combination with the albumin test. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit, Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.
(Adolescents Group at Visit 3: N=20 one participant with missing data; Older Children at Visit 2: N=27 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data)."||g/L||Standard Deviation|Mean
668171|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Liver Function Test - Lactate Dehydrogenase (LDH) Enzyme Activity|Lactate Dehydrogenase (LDH) was used to check for tissue damage. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit, Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.
(Adolescents Group at Visit 3: N=20 one participant with missing data; Older Children at Visits 1 and 3: N=26 and at Visit 2 N=24 participants; Young and Very Young Children Group at Visits 1 and 3: N=16 participant with missing data)."||U/L||Standard Deviation|Mean
668172|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Liver Function Test - Bilirubin Concentration|Old red blood cells are replaced by new blood cells every day. Bilirubin is made by the body when the old blood cells are removed. The concentration of bilirubin in the blood measures liver function. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit, Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.
(Adolescents-Visit 2 & 3: N=20 - 1 participant with data missing; Older Children-Visit 1 & 2: N=26 thus 2 participants with data missing; Young and Very Young Children-Visits 1 & 3: N=12 (5 with data missing) & at Visit 2 N=9 (8 with data missing)."||µmol/L||Standard Deviation|Mean
668173|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Liver Function Test - Gamma-Glutamyl Transferase (GGT) Enzyme Activity|The gamma-glutamyl transferase (GGT) test was used in combination with the alkaline phosphatase (ALP) test. Both ALP and GGT can be elevated in bile duct or liver complications. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit, Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.
(Adolescents Group at Visit 2 and 3: N=20 one participant with missing data; Older Children at Visit 2: N=27 one participant with missing data; Young and Very Young Children Group at Visit 2: N=16 one participant with missing data)."||U/L||Standard Deviation|Mean
668174|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Liver Function Test - Alanine Aminotransferase (ALT) Enzyme Activity|This test was done in combination with other tests (such as AST, ALP, and bilirubin) to diagnose and monitor the liver function. In the study there were 3 planned safety blood draws for routine blood tests. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit, Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.
(Adolescents Group at Visit 3: N=19 two participants with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data)."||U/L||Standard Deviation|Mean
668175|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Urine pH (Acid, Alkalinity) Test|A urine sample was tested right away. A dipstick made with a color-sensitive pad was used. The color indicated the acidity of the urine. In the study there were 2 planned safety urine collections. At Visit 1 in the enrollment period, after consent and assent obtained. The second sample was obtained at Visit 3 prior to discharge from the hospital. The discharge visit was as per standard of care.|Enrollment Visit and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.
(Young and Very Young Children Group at Visits 1: N=9 thus 8 participants with missing data; at Visit 3: N=7 thus 10 participants with missing data)."||units on a scale||Standard Deviation|Mean
668390|NCT01727167|Secondary|Compare Blood to Right Atrial Tissue Biochemical Markers of Mitochondrial Biogenesis|Biochemical markers in both right atrial tissue and blood will be measured and compared to see if the more easily obtained blood markers accurately describe changes expected in the heart.|on week|Molecular data was not collected for the single enrolled participant.|||||
668176|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Urine Specific Gravity|This test was used to test for the water balance and urine concentration. A urine sample was tested right away. A dipstick with a color-sensitive pad was used. The color the dipstick changes and the specific gravity of the urine was read off the color chart. In the study there were 2 planned safety urine collections. At Visit 1 in the enrollment period, after consent and assent obtained. The second sample was obtained at Visit 3 prior to discharge from the hospital. The discharge visit was as per standard of care.|Enrollment Visit and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.
(Young and Very Young Children Group at Visits 1: N=9 thus 8 participants with missing data; at Visit 3: N=7 thus 10 participants with missing data)."||units on a scale||Standard Deviation|Mean
668177|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Calculated Glomerular Filtration Rate|Glomerular filtration rate (GFR) was done to check how well the kidneys are working. It estimates how much blood passes through the glomeruli in the kidney each minute. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.
(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data)."||mL/min/1.73m^2||Standard Deviation|Mean
668178|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Urate in the Blood|Uric acid (urate is the salt) is a chemical created when the body breaks down substances called purines. Most urate dissolves in blood and travels to the kidneys. From there, it passes out in the urine. The test is used to determine kidney function. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.
(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data)."||µmol/L||Standard Deviation|Mean
668179|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Serum Albumin Concentration|Albumin is a protein made by the liver. Albumin prevents fluid leaking into the tissues. Albumin also transports many small molecules. Serum albumin was measured in the clear liquid portion of the blood called serum. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.
(Adolescents Group at Visit 3: N=20 one participant with missing data; Older children N=27 at Visit 1; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data)."||g/L||Standard Deviation|Mean
668180|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Triglycerides Concentration|Triglycerides are a group of fat. Triglycerides were measured as part of metabolic and cardiac assessments. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.
(Adolescents Group at Visit 3: N=20 one participant data missing; Older children Visits 2 and 3: N=27 and N=26 one and two participant data missing; Young and Very Young Children Group at Visits 2 and 3: N=16 one participant data missing)."||mmol/L||Standard Deviation|Mean
668181|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Aspartate Aminotransferase (AST) Enzyme Activity|AST is considered to be one of the two most important tests to detect liver injury. During liver damage the enzyme is released into the blood. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.
(Adolescents Group at Visit 3: N=20 one participant with missing data; Older children at Visits 2 and 3: N=26 two participants with missing data; Young and Very Young Children Group at Visits 1 and 3: N=16 one participant with missing data)."||U/L||Standard Deviation|Mean
668182|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Creatinine Concentration|Creatinine is removed from the body entirely by the kidneys. If kidney function is not normal, creatinine level increases in the blood. In the study there were 3 planned safety blood draws for routine blood tests. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.
(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data)."||µmol/L||Standard Deviation|Mean
668183|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Blood Urea Nitrogen (BUN) Concentration|This test is to measure the amount of urea nitrogen in the blood. It was used to test liver and kidney function. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.
(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data)."||mmol/L||Standard Deviation|Mean
668730|NCT01721096|Secondary|Target Vessel Revascularization (TLR or TVR Non-TLR)|Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR non-TLR) or non-ischemia driven TVR (TLR or TVR non-TLR)|8 months post index procedure|||percentage of participants|||Number
668184|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Blood Phosphate Concentration|Phosphate is needed by the body. This test was done to see how much phosphate is in the blood. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.
(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data)."||mmol/L||Standard Deviation|Mean
668185|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Blood Chloride Concentration|Chloride with other electrolytes help keep the proper balance of body fluids and maintain the body's acid-base balance. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.
(Adolescents Group at Visit 3: N=20 one participant with missing data; Older children Group at Visit 2: N=27 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data)."||mmol/L||Standard Deviation|Mean
668186|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Blood Calcium Concentration|All cells need calcium in order to function. In the study there were 3 planned safety blood draws for routine blood tests. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.
(Adolescents Group at Visit 3: N=20 one participant with missing data; Older children Group at Visit 2: N=27 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data)."||mmol/L||Standard Deviation|Mean
668187|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Blood Potassium Concentration|Potassium is a mineral that the body needs to work normally. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.
(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data)."||mmol/L||Standard Deviation|Mean
668188|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Blood Sodium Concentration|Sodium is required by the body for the body to function properly. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.
(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data)."||mmol/L||Standard Deviation|Mean
668189|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Blood Glucose Concentration|A blood glucose test measures the amount of a sugar called glucose in blood. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.
(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data)."||mmol/L||Standard Deviation|Mean
668190|NCT01729728|Secondary|Hematology Safety Laboratory Assessments: Leukocyte Concentration|Leukocytes are also called white blood cells (WBC). These were measured to assess immune function. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.
(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visits 2 and 3: N=16 one participant with missing data at each visit)."||GI/L||Standard Deviation|Mean
668191|NCT01729728|Secondary|Hematology Safety Laboratory Assessments: Platelet Count|Platelets are cell fragments that are vital for normal blood clotting. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.
(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visits 2 and 3: N=16 one participant with missing data at each of these visits)."||GI/L||Standard Deviation|Mean
668192|NCT01729728|Secondary|Hematology Safety Laboratory Assessments: Erythrocyte Mean Corpuscular Volume (Mean Corpuscular Volume)|Erythrocyte Mean Corpuscular volume is a measurement of the average size of Red Blood Cells (RBC). It is also referred to as Mean Corpuscular Volume. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.
(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visits 2 and 3: N=16 one participant with missing data at each of these visits)."||fL||Standard Deviation|Mean
668193|NCT01729728|Secondary|Hematology Safety Laboratory Assessments: Hematocrit|Hematocrit is a blood test that measures the percentage of the volume of whole blood that is made up of red blood cells (RBC). This measurement depends on the number of red blood cells and the size of red blood cells. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.
(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visits 2 and 3: N=16 one participant with missing data at each of these visits)."||fraction of blood volume||Standard Deviation|Mean
668194|NCT01729728|Secondary|Hematology Safety Laboratory Assessments: Hemoglobin Concentration|The hemoglobin test is a commonly ordered blood test and was done as part of a complete blood count (CBC). It is routinely done before and after surgery to check for anemia, the presence of chronic kidney disease or other chronic medical problems. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.
(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visits 2 and 3: N=16 one participant with missing data at each of these visits)."||g/L||Standard Deviation|Mean
668195|NCT01729728|Primary|Non-Compartmental Pharmacokinetic (PK) Parameter: Time to Maximum Concentration (Tmax) of Tapentadol-O-glucuronide After a Single Dose of Tapentadol in Adolescents (Age 12 to Less Than 18).|"Tapentadol-O-glucuronide is the metabolite of tapentadol. Metabolites are sometimes referred to as breakdown products. The body alters the administered medication to a metabolite so that it can be more easily or quickly removed from the body. Serum samples for pharmacokinetic analysis were obtained using frequent sampling techniques in participants 12 years to less than 18 years of age. The time to maximum concentration is derived from the area under the curve from dose to 15 hours (AUC 0-15). The Tmax is the time after dosing at which the maximum concentration of the tapentadol-O-glucuronide (metabolite) occurs. Serum samples (frequent sampling) were drawn at 0.25, 0.5, 1, 2, 4, 6, 11, and 15 hours."|up to 15 hours|The protocol planned that this analysis would only be performed for the adolescent participants.||hours||Standard Deviation|Mean
668196|NCT01729728|Primary|Non-Compartmental Pharmacokinetic (PK) Parameter: Cmax (Maximum Concentration) of Tapentadol-O-glucuronide After a Single Dose of Tapentadol in Adolescents (Age 12 to Less Than 18 Years).|"Tapentadol-O-glucuronide is the metabolite of tapentadol. Metabolites are sometimes referred to as breakdown products. The body alters the administered medication to a metabolite so that it can be more easily or quickly removed from the body. Serum samples (frequent sampling) were drawn at 0.25, 0.5, 1, 2, 4, 6, 11, and 15 hours. The concentration of tapentadol-O-glucuronide (metabolite) is assessed to study absorption and distribution.
The maximum concentration is derived from the Area Under the Curve, from dose to 15 hours (AUC 0-15). It is the highest amount of metabolite observed in the blood sample."|up to 15 hours|The protocol planned that this analysis would only be performed for the adolescent participants.||nanogramsg/millilitre||Standard Error|Mean
668197|NCT01729728|Primary|Non-Compartmental Pharmacokinetic (PK) Parameter of Tapentadol-O-glucuronide Area Under the Concentration-Time Curve (AUC 0-15) After a Single Dose of Tapentadol in Adolescents (Age 12 to Less Than 18 Years).|"Serum samples for pharmacokinetic analysis were obtained using frequent sampling techniques in participants 12 years to less than 18 years of age.
Serum samples (frequent sampling) were drawn at 0.25, 0.5, 1, 2, 4, 6, 11, and 15 hours. The concentration of tapentadol (active drug) is assessed during absorption and distribution.
The maximum concentration is derived from the Area Under the Curve, from dose to 15 hours (AUC 0-15). It is the highest amount of active drug observed in the blood sample."|up to 15 hours|The protocol planned that this analysis would only be performed for the adolescent participants.||ng*hr/mL||Full Range|Mean
668198|NCT01729728|Primary|Non-Compartmental Pharmacokinetic (PK) Parameter: Time to Maximum Concentration (Tmax) of Tapentadol After a Single Dose of Tapentadol in Adolescents (Age 12 to Less Than 18 Years).|"Serum samples for pharmacokinetic analysis were obtained using frequent sampling techniques in participants 12 years to less than 18 years of age.
The time to maximum concentration is derived from the area under the curve from dose to 15 hours (AUC 0-15). The Tmax is the time after dosing at which the maximum concentration of the tapentadol (active drug) occurs.
Serum samples (frequent sampling) were drawn at 0.25, 0.5, 1, 2, 4, 6, 11, and 15 hours."|up to 15 hours|The protocol planned that this analysis would only be performed for the adolescent participants.||hours||Standard Deviation|Mean
668199|NCT01729728|Secondary|Intake of Additional Analgesic Medication During the Trial|Number of participants with intakes of supplemental analgesic medication between investigational medicinal product (IMP) intake and Site Discharge grouped according to preparation taken (non-opioid/opioid).|Baseline; 15 hours post dosing|The protocol pre-specified that the young and very young children will be reported as one group.||participants|||Number
668200|NCT01729728|Secondary|Treatment Emergent Adverse Events by Intensity|"The intensity of all treatment emergent adverse events (TEAEs) were scored by the investigator. Treatment emergent adverse events were those adverse events documented from the time of investigational medicinal product (IMP), study drug, up to 48 hours post dosing.
The clinical “intensity” of an adverse event was classified as:
Mild: Signs and symptoms that can be easily tolerated. Symptoms can be ignored and disappear when the subject is distracted.
Moderate: Symptoms cause discomfort but are tolerable; they cannot be ignored and affect concentration.
Severe: Symptoms which affect usual daily activity.
For adverse events where the intensity changes over time, the maximum intensity observed was documented."|Baseline; 48 hours post dosing|The protocol pre-specified that the young and very young children will be reported as one group.||number of events|||Number
668211|NCT01729728|Primary|Pharmacokinetic Profile of Serum Concentrations of Tapentadol After a Single Dose of Tapentadol Oral Solution in Younger Children (Age 3 to Less Than 6 Years).|Mean and Standard Deviation of Serum Concentrations of Tapentadol. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 0.2 ng/mL.|up to 15 hours|||nanogram per milliliter||Standard Deviation|Mean
675777|NCT01635244|Primary|Aortic Valve Mean Gradient (mm Hg) at Peak Exercise|This is a measure of the resistance to flow across the aortic bioprosthesis.|6 months after aortic valve replacement|||mm Hg||Inter-Quartile Range|Median
668201|NCT01729728|Primary|Non-Compartmental Pharmacokinetic (PK) Parameter: Cmax (Maximum Concentration) of Tapentadol After a Single Dose of Tapentadol in Adolescents (Age 12 to Less Than 18 Years).|"Serum samples for pharmacokinetic analysis were obtained using frequent sampling techniques in participants 12 years to less than 18 years of age.
Serum samples (frequent sampling) were drawn at 0.25, 0.5, 1, 2, 4, 6, 11, and 15 hours. The concentration of tapentadol (active drug) is assessed during absorption and distribution.
The maximum concentration is derived from the Area Under the Curve, from dose to 15 hours (AUC 0-15). It is the highest amount of active drug observed in the blood sample"|up to 15 hours|The protocol planned that this analysis would only be performed for the adolescent participants.||nanograms/millilitre||Standard Error|Mean
668202|NCT01729728|Secondary|Change From Enrollment in 12-lead Electrocardiogram Heart Rate Parameter|"12-lead Electrocardiograms (ECG) were part of the planned safety assessments. 12-lead Electrocardiograms were performed prior at the enrollment visit after informed consent and at the discharge visit. The discharge visit was as per standard of care.
The changes in heart rate (beats per minute) parameters are reported per treatment group between the visits.
A positive value indicates that the heart rate was higher at discharge than at enrollment."|Enrollment; Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.
(For older children: N=27 at Visit 1)"||beats per minute||Standard Deviation|Mean
668203|NCT01729728|Secondary|Change From Enrollment in 12-lead Electrocardiogram Parameters|"12-lead electrocardiograms (ECG) were part of the planned safety assessments. 12-lead Electrocardiograms were performed prior at the enrollment visit after informed consent and at the discharge visit. The discharge visit was as per standard of care.
The changes in ECG parameters are reported. Negative mean values indicate that the millisecond intervals decreased from the enrollment to the discharge visit. Positive mean values indicate that the millisecond intervals increased from the enrollment to the discharge visit. The Letters P,Q,R,S and T refer to specific medically defined points on an ECG tracing and correspond to specific heart activities."|Enrollment (pre-surgery); Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.
(For older children N=27 at Visit 1)"||milliseconds||Standard Deviation|Mean
668204|NCT01729728|Secondary|Systolic and Diastolic Blood Pressure Assessments|"Systolic and Diastolic blood pressure assessments were performed at pre-defined times during the 15 hour period following investigational medicinal product intake.
Pre-surgery data for these participants is also given from the enrollment Visit (Visit 1)."|Enrollment Visit; 15 hours post-dose|"The protocol pre-specified that the young and very young children will be reported as one group.
(Adolescents Group at and after 2 hours: N=20; Older Children Group at 30 minutes and 1 hour N=27, at 2 hours N=24, at and after 4 hours N=22; Young and Very Young Children Group at and after 4 hours: N=16)."||mmHg||Standard Deviation|Mean
668205|NCT01729728|Secondary|Oxygen Saturation Assessments|"Oxygen saturation assessments were performed at pre-defined times during the 15 hour period following investigational medicinal product intake.
Oxygen saturation was assessed using pulse oximetry. The uppermost value is 100%.
Pre-surgery data for these participants is also given from the enrollment Visit (Visit 1)."|Enrollment Visit; 15 hours post-dose|"The protocol pre-specified that the young and very young children will be reported as one group.
(Adolescents Group at and after 2 hours: N=20; Older Children Group at 30 minutes and 1 hour N=27, at 2 hours N=24, at and after 4 hours N=22; Young and Very Young Children Group at and after 4 hours: N=16)."||percentage of oxygen saturation||Standard Deviation|Mean
668206|NCT01729728|Secondary|Respiratory Rate Assessments|"Respiratory rate assessments were performed at pre-defined times during the 15 hour period following investigational medicinal product intake.
Pre-surgery data for these participants is also given from the enrollment Visit (Visit 1)."|Enrollment Visit; 15 hours post-dose|"The protocol pre-specified that the young and very young children will be reported as one group.
(Adolescents Group at and after 2 hours: N=20; Older Children Group at 30 minutes and 1 hour N=27, at 2 hours N=24, and at and after 4 hours N=22; Young and Very Young Children Group at and after 4 hours: N=16)."||breaths per minute||Standard Deviation|Mean
668207|NCT01729728|Primary|Non-Compartmental Pharmacokinetic (PK) Parameter of Tapentadol Area Under the Concentration-Time Curve (AUC 0-15) After a Single Dose of Tapentadol in Adolescent Participants (Age 12 to Less Than 18 Years).|"Serum samples for pharmacokinetic analysis were obtained using frequent sampling techniques in participants 12 years to less than 18 years of age.
Serum samples (frequent sampling) were drawn at 0.25, 0.5, 1, 2, 4, 6, 11, and 15 hours.
The Area Under the Curve (AUC) from dose to 15 hours (AUC 0-15) is a summary measure of data from each pharmacokinetic blood sample taken over the 15 hour time period.
The area is that below the line fitted to the data points."|up to 15 hours|The protocol planned that this analysis would only be performed for the adolescent participants.||ng*hr/mL||Full Range|Mean
668208|NCT01729728|Primary|Pharmacokinetic Profile of Serum Concentrations of Tapentadol-O-glucuronide After a Single Dose of Tapentadol Oral Solution in Very Young Children (Age 2 to Less Than 3 Years).|"Mean and Standard Deviation of Serum Concentrations of Tapentadol-O-glucuronide. Tapentadol-O-glucuronide is the metabolite of tapentadol. Metabolites are sometimes referred to as breakdown products. The body alters the administered medication to a metabolite so that it can be more easily or quickly removed from the body. Tapentadol-O-glucuronide concentrations were measured in participants. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 10 ng/mL."|up to 15 hours|||nanogram per milliliter||Standard Deviation|Mean
668209|NCT01729728|Primary|Pharmacokinetic Profile of Serum Concentrations of Tapentadol After a Single Dose of Tapentadol Oral Solution in Very Young Children (Age 2 to Less Than 3 Years).|Mean and Standard Deviation of Serum Concentrations of Tapentadol. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 0.2 ng/mL.|up to 15 hours|||nanogram per milliliter||Standard Deviation|Mean
668210|NCT01729728|Primary|Pharmacokinetic Profile of Serum Concentrations of Tapentadol-O-glucuronide After a Single Dose of Tapentadol Oral Solution in Younger Children (Age 3 to Less Than 6 Years).|"Mean and Standard Deviation of Serum Concentrations of Tapentadol-O-glucuronide. Tapentadol-O-glucuronide is the metabolite of tapentadol. Metabolites are sometimes referred to as breakdown products. The body alters the administered medication to a metabolite so that it can be more easily or quickly removed from the body. Tapentadol-O-glucuronide concentrations were measured in participants. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 10 ng/mL."|up to 15 hours|||nanogram per milliliter||Standard Deviation|Mean
668212|NCT01729728|Primary|Pharmacokinetic Profile of Serum Concentrations of Tapentadol-O-glucuronide After a Single Dose of Tapentadol Oral Solution in Older Children (Age 6 to Less Than 12 Years).|"Mean and Standard Deviation of Serum Concentrations of Tapentadol-O-glucuronide. Tapentadol-O-glucuronide is the metabolite of tapentadol. Metabolites are sometimes referred to as breakdown products. The body alters the administered medication to a metabolite so that it can be more easily or quickly removed from the body. Tapentadol-O-glucuronide concentrations were measured in participants. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 10 ng/mL."|up to 15 hours|||nanogram per milliliter||Standard Deviation|Mean
668213|NCT01729728|Primary|Pharmacokinetic Profile of Serum Concentrations of Tapentadol After a Single Dose of Tapentadol Oral Solution in Older Children (Age 6 to Less Than 12 Years).|Mean and Standard Deviation of Serum Concentrations of Tapentadol. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 0.2 ng/mL.|up to 15 hours|||nanogram per milliliter||Standard Deviation|Mean
668214|NCT01729728|Primary|Pharmacokinetic Profile of Serum Concentrations of Tapentadol-O-glucuronide After a Single Dose of Tapentadol Oral Solution in Adolescents (Age 12 to Less Than 18 Years).|"Mean and Standard Deviation of Serum Concentrations of Tapentadol-O-glucuronide. Tapentadol-O-glucuronide is the metabolite of tapentadol. Metabolites are sometimes referred to as breakdown products. The body alters the administered medication to a metabolite so that it can be more easily or quickly removed from the body. Tapentadol-O-glucuronide concentrations were measured in participants. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 10 ng/mL."|up to 15 hours|||nanogram per milliliter||Standard Deviation|Mean
668215|NCT01729728|Secondary|Sum of Pain Intensity Differences Over the 4 Hours After Dosing Derived From the Different Pain Scales and for All Age Groups|"Different pain intensity assessment tools were used in the different age groups. Therefore the sum of pain intensities were calculated and are reported for each age group based on the tool used.
Adolescents - Age 12 to Less Than 18 Years.
Older Children - Age 6 to Less Than 12 Years.
Young Children - Age 3 to Less Than 6 Years.
Very Young Children - Age 2 to Less Than 3 Years.
CAS (McGrath color analog scale) [Theoretical Range: -40 to + 40],
VAS (100 mm Visual Analog Scale) [Theoretical Range: -400 to + 400],
FPS-R (6-point Faces Pain Scale - Revised) [Theoretical Range: -40 to + 40],
FLACC (Face, Legs, Activity, Cry, and Consolability score) [Theoretical Range: -40 to + 40].
A mean score of zero indicates that there was no pain intensity change over the 4 hours.
The positive values indicate that in the group as a whole the sum of all pain intensity values over the first 4 hours lead to a reduction in pain in the time period."|Baseline; 4 hours post-dose|Protocol pre-specified reporting groups.||units on a scale||Standard Deviation|Mean
668216|NCT01729728|Secondary|Pain Intensity Assessment Using the Face, Legs, Activity, Cry, Consolability Scale in Young and Very Young Children (Age 2 to Less Than 6 Years).|The Face Legs Activity Cry Consolability (FLACC) Scale was developed by the Department of Anesthesiology, University of Michigan Medical School and Health Systems. The FLACC Scale is a behavioral scale for scoring postoperative pain in children between the ages of two months and seven years or in persons unable to communicate. In this trial the scale was used in the young and very young children, i.e. in participants aged 2 to less than 6 years. This tool includes five categories of pain behaviors, including facial expression, leg movement, activity, cry, and consolability. The clinician observes the participant for 5 minutes or more and scores each category with a 0, 1 or 2. The scores are added together for a total score ranging from 0 (no pain) to 10 (worst pain). The higher the total score the higher the pain.|Baseline; 15 hours post-dose|The protocol pre-specified that the young and very young children will be reported as one group.||units on a scale||Standard Deviation|Mean
668217|NCT01729728|Secondary|Pain Intensity Assessments Using the Faces Pain Scale (Revised) in Children Age 3 to Less Than 12 Years.|"This assessment tool was used in 3 to less than 12 year old participants, i.e. Older Children and Young Children.
The Faces Pain Scale (Revised) [FPS-R] score as allocated to a selected face by the participant. There are 6 faces and the participant is asked to indicate on a face to express how much it hurts.
The numeric value 0 (no pain) to 10 (very much pain) is read off the reverse side of the scale by the clinician."|Baseline; 15 hours post-dose|The protocol pre-specified that the Faces Pain Scale (Revised) would not be administered in the very young participants (aged 2 to less than 3 years).||units on a scale||Standard Deviation|Mean
668218|NCT01729728|Secondary|Pain Intensity Assessments Using the McGrath Color Analog Scale in Adolescent Participants and Older Children (Age 6 to Less Than 18 Years).|Pain intensity assessments were with a 0 (no pain) to 10 (worst pain) scored McGrath color analog scale (CAS) in participants aged 6 years to less than 18 years, i.e. in Adolescents and Older Children. Participants were presented with the CAS and instructed to place the sliding bar on the color that best represented their pain intensity level at the time of assessment. The CAS is a pocket size tool used to measure the self-reported pain intensity of the older participants. The CAS consists of a 145 mm long triangular shaped strip of plastic, varying in width and hue from 1 mm wide and light pink hue at the bottom (and text no pain), to 3 mm wide and deep red hue at the top (most pain). This instrument includes 2 sides. One side shows the color pain intensity scale as described and the other shows a graduated scale, which provides a specific numeric value for the participant-reported level of pain.|Baseline; 15 hours post-dose|Protocol pre-specified reporting groups.||units on a scale||Standard Deviation|Mean
668219|NCT01729728|Secondary|Pain Intensity Assessments Using the Visual Analog Scale (VAS) in Adolescents (Age 12 to Less Than 18 Years).|"At predefined times after investigational medicinal product administration, participants were asked to rate their pain on a 100 mm line (visual analog scale - VAS) by marking a point on the line in response to:
“My pain at this time is”. The mark was scored between “no pain” and ” pain as bad as it could be”. The distance was then measured by a clinician and reported.
A value of 0 indicates no pain. A value of 100 indicates pain as bad as it could be."|Baseline; 15 hours|Protocol pre-specified reporting groups.||units on a scale||Standard Deviation|Mean
668220|NCT01729728|Primary|Pharmacokinetic Profile of Serum Concentrations of Tapentadol After a Single Dose of Tapentadol Oral Solution in Adolescents (Age 12 to Less Than 18 Years).|Mean and Standard Deviation of Serum Concentrations of Tapentadol. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 0.2 ng/mL.|up to 15 hours|||nanogram per milliliter||Standard Deviation|Mean
668221|NCT01729559|Secondary|Heparin Induced Thrombocytopenia|The possible occurrence of heparin induced thrombocytopenia (HIT) was investigated when any patient (in either low molecular weight heparin [LMWH] or low dose unfractionated heparin [LDUH] study arm) had a platelet count drop of ≥50% (from a baseline value at the time of initiation of VTE prophylaxis) between day 5 and 14 following initiation of chemoprophylaxis per American College of Chest Physicians (ACCP) guidelines.|Within 30 of admission to hospital|||participants|||Number
668222|NCT01729559|Secondary|Bleeding Event|Bleeding events will be classified by the Graafsma et al. severity of bleeding criteria (Major, Minor or No Bleeding). A major bleeding event will be defined as any overt bleeding following initiation of chemoprophylaxis associated with one or more of the following; a decrease in hemoglobin of ≥2 g/dL, bleeding leading to a transfusion of ≥2 units of packed red blood cells, a new retroperitoneal or intracranial bleed, or bleeding that warranted cessation of chemoprophylaxis treatment. Minor bleeding is defined as clinically evident bleeding not meeting criteria for major bleeding.|Within 30 days of admission to hospital|||participants|||Number
668223|NCT01729559|Primary|Pulmonary Embolus|Patients with any or all of the following signs and symptoms suggestive of pulmonary embolism will have a CT angiogram (CTA) performed for diagnosis: Sudden onset of dyspnea, deterioration of existing dyspnea, decreased oxygen saturation (<92%), onset of pleuritic chest pain without another apparent cause, onset of tachycardia (>100), evidence of hypoxemia, hypocapnia, or respiratory alkalosis on arterial blood gas, or electrocardiographic changes reflecting right ventricular strain.|Within 30 days from admission to hospital|||participants|||Number
668224|NCT01729559|Primary|Lower Extremity Deep Vein Thrombosis|Patients will have a bilateral lower extremity duplex ultrasound performed by a registered vascular technologist twice per week if the patient is in the ICU, or once per week if the patient is on the trauma ward. All of the deep veins from the external iliac to and including the calf veins will be interrogated. Diagnosis of deep vein thrombosis (DVT) will be defined as absence of complete vein compressibility, presence of an echogenic thrombus within the vein, absence of color flow characteristics including lack of spontaneity, phasicity, pulsatility and augmentability as noted in the clinical practice guidelines of the American Thoracic Society. The vascular technologist and physician reading the ultrasound study will be blinded to the patient's enrollment status and randomization arm/medication group.|Within 30 days of hospital admission|||percentage of patients|||Number
668225|NCT01729338|Secondary|Risk Score as Assessed Using the Cancer and Leukemia Group B (CALGB) Geriatric Assessment Tool|Calculation of the risk score requires that the patient be assessed with the CALGB Assessment Tool, which has both a patient self-reporting questionnaire and a clinician assessment. Both will be used in this trial, and thus patients will have risk scores based on their own self-assessments and risk scores based on the clinicians’ assessment. The risk score ranges from 0-19, with 0-5 indicating low risk, 6-9 intermediate risk, and 10-19 high risk. The distribution of the risk score in this trial will be described by plotting the median of the risk score against time, with patient and clinician assessments overlaid on the same plot.|Day 1|Data for the risk score wasn’t recorded correctly, and therefore we were unable to analyze the data.|||||
668226|NCT01729338|Secondary|Functionality as Assessed Using the Cancer and Leukemia Group B (CALGB) Geriatric Assessment Tool|"Mean functionality in study subjects, quantitatively scored using the standardized and validated Cancer and Leukemia Group B (CALGB) Geriatric Assessment Tool, which comprehensively assesses aspects of a patient's functionality such as symptoms (e.g., pain, anxiety), social support (e.g., someone to turn to for help), and ability to carry out routine activities (e.g., grocery shopping) or physical exertion (e.g., climbing stairs) was assessed at baseline.
The score is obtained by inserting patient-specific data into the online calculator found at http://www.mycarg.org/Chemo_Toxicity_Calculator, which is based on the risk score described in Hurria A, Togawa K, Mohile SG, et al. Predicting chemotherapy toxicity in older adults with cancer: a prospective multicenter study. J Clin Oncol. 2011;29(25):3457-3465.
The risk score ranges from 0-19, with 0-5 indicating low risk, 6-9 intermediate risk, and 10-19 high risk for severe (grade >2) toxicity."|baseline|Participants who completed functionality assessment at baseline. Data were incompletely and irregularly collected after baseline so unable to analyze additional time points.||Scores on a scale||Standard Deviation|Mean
668227|NCT01729338|Secondary|QLQ-C30 Question 30|"Measured as mean quality of life in study subjects, quantitatively scored using the standardized and validated European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ). Question 30: How would you rate your overall quality of life during the past week?
7 point scores are standardized to a scale of 0-100, where 100 means highest possible quality."|baseline, 3 months, 5 months|Participants who completed questionnaire.||units on a scale||Standard Deviation|Mean
668228|NCT01729338|Secondary|QLQ-C30 Question 29|Measured as mean quality of life in study subjects, quantitatively scored using the standardized and validated European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ). Question 29: how would you rate your overall health during the past week? 7 point scores are standardized to a scale of 0-100, where 100 means highest possible quality.|baseline, 3 months, 5 months|Participants who completed questionnaire.||units on a scale||Standard Deviation|Mean
668229|NCT01729338|Secondary|Median Overall Survival|Defined as median time elapsed in study subjects between initiation of study therapy and death, regardless of cause.|Up to 3 years|||months||Standard Deviation|Median
668230|NCT01729338|Secondary|Median Progression-free Survival|Defined as median time elapsed in study subjects between initiation of study therapy and either disease progression or death, regardless of cause of death.|4 years|||months||Standard Deviation|Median
668231|NCT01729338|Secondary|Median Duration of Response|Defined as median time elapsed in study subjects between achievement of response and disease progression.|From date of first confirmed response until date of disease progression or up to 3 years|9 out of all patients achieved response and hence could be analyzed for duration of response||months||Standard Deviation|Median
668232|NCT01729338|Secondary|Median Time to Response|Defined as median time to achievement of response (partial remission or better by International Myeloma Working Group standard criteria), in study subjects during 8 months of induction chemotherapy.|Up to 8 months|||months||Standard Deviation|Median
668248|NCT01729026|Secondary|Patient Health Questionnaire-9 (PHQ-9)|Self-rating scale that assesses the presence and severity of the symptoms of a DSM-IV major depressive episode|Baseline and 1-month, 3-month, 4-month, and 6-month follow-up||||||
668249|NCT01729026|Secondary|MINI International Neuropsychiatric Inventory (MINI)|Semi-structured interview used to assess the presence of 15 common DSM-IV psychiatric diagnoses.|Baseline||||||
668233|NCT01729338|Secondary|Maximum Depth of Response During Maintenance Therapy|"Defined as maximum depth of response (ranging from partial response to complete response by International Myeloma Working Group (IMWG) criteria at any point during post-induction maintenance therapy.
IMWG: Complete Response (CR): negative immunofixation on the serum and urine, no soft tissue plasmacytomas and <5% plasma cells in the bone marrow; stringent CR: CR+normal free light chain ratio, no clonal cells in bone marrow by immunohistochemistry or immunofluorescence; Very Good Partial Response: serum and urine M-protein detected by immunofixation but not electrophoresis, >90% in serum M-protein+urine, M-protein level <100 mg/24hour; Partial Response (PR): ≥50% decrease of serum and M-protein, 24 hour urinary M-protein decrease by ≥90% or <200 mg/24hour. Stable disease mean that the patient has not achieved CR, VGPR, PR or progressive disease."|Up to 3 years|8 of all subjects reached maintenance and could be analyzed||percentage of participants|||Number
668234|NCT01729338|Secondary|Maximum Depth of Response During Induction Therapy|Maximum depth of response is defined as: ranging from partial response to complete response by International Myeloma Working Group (IMWG). Described as number of patients achieving each level of response. IMWG: CR: negative immunofixation on the serum and urine, no soft tissue plasmacytomas and <5% plasma cells in the bone marrow; sCR: CR+normal free light chain ratio, no clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR: serum and urine M-protein detected by immunofixation but not electrophoresis, >90% in serum M-protein+urine, M-protein level <100 mg/24hour; PR: ≥50% decrease of serum and M-protein, 24 hour urinary M-protein decrease by ≥90% or <200 mg/24hour. Stable disease mean that the patient has not achieved CR, VGPR, PR or progressive disease.|Up to 8 months|||percentage of participants|||Number
668235|NCT01729338|Secondary|Severe Adverse Event Rate|Defined as number of patients experiencing any grade or severe (≥ grade 3 by common toxicity criteria for adverse events (CTCAE) v4.0 criteria) adverse events at any time during the study|Up to 3 years|||percentage of participants|||Number
668236|NCT01729338|Primary|Overall Response Rate (ORR) During Induction Therapy|"Defined as percentage of patients achieving a partial response or better by International Myeloma Working Group (IMWG) standard criteria:
IMWG: Complete Response (CR): negative immunofixation on the serum and urine, no soft tissue plasmacytomas and <5% plasma cells in the bone marrow; stringent CR: CR+normal free light chain ratio, no clonal cells in bone marrow by immunohistochemistry or immunofluorescence; Very Good Partial Response: serum and urine M-protein detected by immunofixation but not electrophoresis, >90% in serum M-protein+urine, M-protein level <100 mg/24hour; Partial Response (PR): ≥50% decrease of serum and M-protein, 24 hour urinary M-protein decrease by ≥90% or <200 mg/24hour."|Up to 8 months|||percentage of participants|||Number
668237|NCT01729247|Secondary|Asthma Management Changes After FeNO Results Were Considered|Assessment of airway inflammation was performed by an allergist or nurse practitioner/physicians assistant prior to knowledge of fractional exhaled nitric oxide (FeNO) results. Airway inflammation was categorized as low, intermediate or high. Based on these assessments asthma medications were prescribed (prior to knowledge of FeNO results). Following the initial prescriptions, the physicians were informed of FeNO results, and any changes to asthma medication prescriptions were recorded. Asthma medications included short-acting beta-agonist (SABA), inhaled corticosteroid (ICS), ICS/long-acting beta-agonist (LABA), leukotriene receptor antagonist (LTRA), and oral corticosteroid (OCS).|Study visit (single visit study). Approximately1 hour.|||participants|||Number
668238|NCT01729247|Secondary|Number of Participants Correctly Categorized by True Level of Airway Inflammation|Assessment of airway inflamation was performed by an allergist or nurse practioner/physicians assistant prior to knowledge of forced exhaled nitric oxide (FeNO) results. Airway inflamation was categorized as low, intermediate or high. A summary of the number of participants with correctly identified airway inflammation assessments by the physician for each true level of inflammation are displayed below.|Study visit (single visit study) approximately 1 hour.|||participants correctly categorized|||Number
668239|NCT01729247|Secondary|Physician Assessment of Airway Inflammation|Assessment of airway inflammation was performed by an allergist or nurse practitioner/physicians assistant prior to knowledge of forced exhaled nitric oxide (FeNO) results. Airway inflammation was categorized as low, intermediate or high. Mean FeNO results were summarized by the physicians assessment of airway inflammation (low, intermediate, high, or unsure).|Study visit (single visit study) approximately 1 hour|||parts per billion (ppb)||Standard Deviation|Mean
668240|NCT01729247|Primary|FeNO Categorical Levels by ICS Use|Fractional exhaled nitric oxide (FeNO) is measured using a NIOX MINO device. FeNO measurements were categorized into low (<25 ppb), intermediate (>=25 to <=50 ppb) and high (>50 ppb). Number of participants falling into FeNO categories were then categorized as those that used inhaled corticosteroids (ICS) or ICS/long-acting beta-agonist (LABA) and those who did not use ICS or ICS/LABA.|Study visit (single visit study). Approximately1 hour.|||participants|||Number
668241|NCT01729247|Primary|FeNO Values by ACT Score|Scores on an asthma control test (ACT) of <=19 indicates less well controlled asthma, scores >19 indicate well controlled asthma. Force exhaled nitric oxide (FeNO) was measured using a NIOX MINO device. FeNO measures were compared against ACT scores.|Study Visit (single visit study). Approximately 1 hour.|||parts per billion (ppb)||Standard Deviation|Mean
668242|NCT01729026|Secondary|Numeric Rating Scale for Pain Intensity|Self-rating scale that assesses pain severity|Baseline and 3-month and 6-month follow-up||||||
668243|NCT01729026|Secondary|Veterans RAND 12-item Health Survey (VR-12)|Self-rating scale that assess physical and mental aspects of health-related quality of life|Baseline and 1-month, 3-month, 4-month, and 6-month follow-up||||||
668244|NCT01729026|Secondary|UCLA Loneliness Scale, Version 3|Self-rating scale to assess symptoms of loneliness|Baseline and 1-month, 3-month, 4-month, and 6-month follow-up||||||
668245|NCT01729026|Secondary|Semi-Structured Interview|Interview that asks open-ended questions to assess the subject's symptoms, quality of life, and experiences related to having a dog|Baseline and 1-month, 3-month, 4-month, and 6-month follow-up visits, as well as 2-week, 2-month, and 4.5-month phone calls||||||
668246|NCT01729026|Secondary|Pittsburgh Sleep Quality Inventory With PTSD Addendum (PSQI-A)|Self-rating scale that assesses the frequency and severity of various sleep-related problems, including problems that frequently occur in persons with PTSD|Baseline and 3-month and 6-month follow-up||||||
668247|NCT01729026|Secondary|Physical Activity Questionnaire (PAQ)|Self-rating scale that assesses the frequency and intensity of various types of physical activity over the previous 3 months.|Baseline and 3-month and 6-month follow-up||||||
668256|NCT01728792|Secondary|Number of Participants With Detected Viral RNA for Each TDV Component After First and Second Vaccinations|"Viral RNA was assessed for the four dengue components: Dengue-1 (TDV-1), Dengue-2 (TDV-2), Dengue-3 (TDV-3) and Dengue-4 (TDV-4). Only those time-points where at least 1 participant had Viral RNA detected are reported. Baseline (Day 0) and Day 7 are added for reference. n in each of the categories is the number of participants with data available."|Days 0, 7, 9, 11, 14, 17, 21, 90, 97 and 104|Participants from the Safety Analysis Set, all enrolled participants who received at least 1 dose of study vaccine, with data available at the given time-point.||participants|||Number
668257|NCT01728792|Primary|Seroconversion Rate to Each of Four Dengue Serotypes|Seroconversion rate was defined as the percentage of participants with Plaque Reduction Neutralization Test titer resulting in 50 % reduction in Plaques (PRNT50) titer ≥ 10 for participants seronegative at Baseline or a greater than four-fold increase in PRNT50 for participants seropositive at Baseline.|Approximately 28 to 30 days after each vaccination (Up to Day 30 and/or Day 104)|Protocol deviations results in testing not performed for outcome measure.|||||
668258|NCT01728792|Primary|Number of Participants With at Least 1 Serious Adverse Event During the Study|"An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment.
A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant."|First Vaccination to End of Study (Up to Day 120)|Safety Analysis Set includes all enrolled participants who received at least 1 dose of study vaccine and for whom post-dosing data was obtained.||participants|||Number
668259|NCT01728792|Primary|Number of Participants With at Least 1 Unsolicited Related Adverse Event Following Either Vaccine Dose|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. The investigator assessed whether the AE was related to the study vaccination.|For 30 days after each vaccination for non-serious AEs and through the end of the study for SAEs (Up to 120 Days)|Safety Analysis Set included all enrolled participants who received at least 1 dose of study vaccine and for whom post-dosing data was obtained.||participants|||Number
668260|NCT01728792|Primary|Number of Participants With Solicited Participant-Reported Systemic Adverse Events (AEs) Following Either Vaccine by Maximum Severity|Solicited systemic AEs were recorded by the participant into a memory aid for 14 days following each vaccination. Solicited systemic AEs included: headache, muscle pain (myalgia), joint pain (arthralgia), eye pain, sensitivity to light (photophobia), tiredness (fatigue), body rash, nausea and vomiting. Systemic AEs were graded per The FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trial where: Grade 0=none to Grade 4=severe. A systemic AE of fever (defined as ≥ 100.4°F) was derived from a daily temperature reading recorded in the memory aid. Solicited systemic AEs are presented as the number of participants reporting the event, by, AE, overall and by severity, using the participant's worst reported severity grade. Group 3 participants received 2 doses 90 days apart; systemic AEs following either vaccination are combined.|For 14 days after each vaccination (Up to Day 14 and/or Day 104)|Participants from the Safety Analysis Set included all enrolled participants who received at least 1 dose of study vaccine and for whom post-dosing data was obtained.||participants|||Number
668261|NCT01728792|Primary|Number of Participants With Solicited Participant-Reported Local (Injection Site) Reactions Following Either Vaccine by Maximum Severity|Injection site reactions were recorded by the participant in a memory aid for 14 days following each injection. Participants measured and recorded the longest diameter of redness (erythema) or swelling (edema) using the scale: 0=< 2.5 cm to 3= Severe: > 10 cm. For pain and itching they recorded intensity grade: 0=not present, 1=mild, 2=moderate or 3=severe. Participant-recorded local reactions are presented as number of participants reporting a reaction, by reaction type, overall and by severity, using the participant’s worst reported severity grade. Only those score categories for which there was at least 1 participant are reported. Group 3 participants received 2 doses 90 days apart; injection site reactions following either vaccination are combined.|For 14 days after each vaccination (Up to Day 14 and/or Day 104)|Participants from the Safety Analysis Set, all enrolled participants who received at least 1 dose of study vaccine and for whom post-dosing data was obtained.||participants|||Number
668262|NCT01728792|Primary|Number of Participants With Solicited Local (Injection Site) Reactions Following Either Vaccine Administration (Day 0 or Day 90) by Maximum Severity as Assessed by the Investigator|Injection site reactions were evaluated by the investigator within 14 days following each injection. Erythema (redness), edema (swelling/induration) and pain were graded per The FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Pain was graded from 0=None to 4=Life-threatening. Erythema and Edema longest diameter were graded using the scale: 0=<2.5 centimeters (cm) to 3=Severe: >10 cm. Itching was graded using Common Terminology Criteria for Adverse Events (CTCAE) 4.03 where: Grade 0=no itching to Grade 3=severe. Injection site reactions are presented as the number of participants experiencing a reaction, by reaction type, overall and by severity, using the participant’s worst reported severity grade. Only categories for which there was at least 1 participant are reported. Group 3 participants received 2 doses 90 days apart; injection site reactions following either vaccination are combined.|For 14 days after each vaccination (Up to Day 14 and/or Day 104)|Safety Analysis Set included all enrolled participants who received at least 1 dose of study vaccine and for whom post-dosing data was obtained.||participants|||Number
668263|NCT01728584|Secondary|Number of Participants Using Pain/Analgesic Medication During Post Operative Period: By Treatment Arm|Post operative use of pain/analgesic medication by participant through Day 8 was recorded.|Up to Day 8|Randomized participants with available data who had NMB or pneumoperitoneum for laparoscopic surgery, or received sugammadex. Participants were included in arm corresponding to treatment actually received, which in case of rescue intervention was the post-intervention condition.||participants using pain medication|||Number
668391|NCT01727167|Primary|Biochemical Markers for Mitochondrial Biogenesis (Blood and Right Atrial Tissue)|Right atrial biochemical markers will be measured one time only, intra-operatively. Blood Biochemical markers will be measured before CO exposure and at intervals up to one week post-operatively|2 weeks|Molecular data was not collected for the single enrolled participant.|||||
668264|NCT01728584|Secondary|Participant's Daily Assessment of Shoulder Pain During Post Operative Period: By Treatment Arm|Participants rated pain at 1, 2, 4, 24 and 48 hours after the administration of sugammadex on day of surgery (Day 1), and daily (in the morning) from Day 3 to Day 8. Pain rating was made using an 11-point scale from 0 (no pain) to 10 (severe pain). Separate ratings were made for overall pain at rest, pain when provoked (e.g., due to participant transition from lying to sitting position) and shoulder pain at rest. This measure summarizes the assessment of shoulder pain for the study days following the surgery.|Days 2 to 8|Randomized participants with available data who had NMB or pneumoperitoneum for laparoscopic surgery, or received sugammadex. Participants were included in arm corresponding to treatment actually received, which in case of rescue intervention was the post-intervention condition.||score on a scale||Standard Deviation|Mean
668265|NCT01728584|Secondary|Participant's Daily Assessment of Provoked Pain During Post Operative Period: By Treatment Arm|Participants rated pain at 1, 2, 4, 24 and 48 hours after the administration of sugammadex on day of surgery (Day 1), and daily (in the morning) from Day 3 to Day 8. Pain rating was made using an 11-point scale from 0 (no pain) to 10 (severe pain). Separate ratings were made for overall pain at rest, pain when provoked (e.g., due to participant transition from lying to sitting position) and shoulder pain at rest. This measure summarizes the assessment of provoked pain for the study days following the surgery.|Days 2 to 8|Randomized participants with available data who had NMB or pneumoperitoneum for laparoscopic surgery, or received sugammadex. Participants were included in arm corresponding to treatment actually received, which in case of rescue intervention was the post-intervention condition.||score on a scale||Standard Deviation|Mean
668266|NCT01728584|Secondary|Participant's Daily Assessment of Overall Pain at Rest During Post Operative Period: By Treatment Arm|Participants rated pain at 1, 2, 4, 24 and 48 hours after the administration of sugammadex on day of surgery (Day 1), and daily (in the morning) from Day 3 to Day 8. Pain rating was made using an 11-point scale from 0 (no pain) to 10 (severe pain). Separate ratings were made for overall pain at rest, pain when provoked (e.g., due to participant transition from lying to sitting position) and shoulder pain at rest. This measure summarizes the assessment of overall pain at rest for the study days following the surgery.|Days 2 to 8|Randomized participants with available data who had NMB or pneumoperitoneum for laparoscopic surgery, or received sugammadex. Participants were included in arm corresponding to treatment actually received, which in case of rescue intervention was the post-intervention condition.||score on a scale||Standard Deviation|Mean
668267|NCT01728584|Secondary|Number of Participants With Rescue Actions Performed During Surgery in Order to Improve Insufficient Surgical Conditions: By Treatment Arm|During procedure, surgeon (who was blinded to random assignment) could request that unblinded anesthetist change the randomized treatment conditions (called a “rescue intervention”), if surgeon considered surgical conditions to be unacceptable. This was to be done systematically as follows: If the participant is on standard NMB, the preferred rescue intervention should be to increase the NMB to a depth of 1-2 PTCs; for such a participant the second option (if participant is also on low insufflation pressure) should be the increase of insufflation pressure by 4 mm Hg. If the participant is already on deep NMB, the preferred option should be (if participant is also on low insufflation pressure) the increase of insufflation pressure by 4 mm Hg. The unblinded anesthetist recorded any rescue actions performed. This measure presents the number of participants: with any rescue action performed, with rescue change in depth of NMB, with rescue change in insufflation pressure level.|During surgery, approximate duration of 1-2 hours (Day 1)|Randomized participants with available data who had NMB and pneumoperitoneum for laparoscopic surgery, and did not convert to open surgery before NMB and/or pressure application. Participants were included in the treatment arm to which they were randomized.||participants|||Number
668268|NCT01728584|Secondary|Score on Surgeon's Assessment of the Effect Participant's Movements During Surgery Had on the Overall Surgical Procedure: By Depth of NMB (Standard, Deep)|"At the end of the procedure the surgeon responds to the following question, using an 11-point scale from 0 (extremely disruptive) to 10 (not disruptive): How did the patient movements described above disrupt your surgical performance? This refers to participant movements during surgery."|End of surgery (Day 1)|Randomized participants with available data who had NMB and pneumoperitoneum for laparoscopic surgery, and did not convert to open surgery before NMB and/or pressure application. Participants were included in the treatment arm to which they were randomized.||score on a scale||95% Confidence Interval|Least Squares Mean
668269|NCT01728584|Secondary|Number of Times Participant's Movements or Increased Muscle Tone Interfered With the Surgical Conditions During Laparoscopy: By Depth of NMB (Standard, Deep)|At the end of the procedure the surgeon responds to the following question: “How many times did patient's movements (coughing, bucking, hiccup) or increased muscle tone (resistance, difficulty to close fasciae or skin) interfere with your surgery?”|During surgery, approximate duration of 1-2 hours (Day 1)|Randomized participants with available data who had NMB and pneumoperitoneum for laparoscopic surgery, and did not convert to open surgery before NMB and/or pressure application. Participants were included in the treatment arm to which they were randomized.||instances of occurrence that interfered||95% Confidence Interval|Least Squares Mean
668270|NCT01728584|Secondary|Score on Surgeon's Assessment of the Overall Adequacy of Insufflation Pressure During Surgery: By Depth of NMB (Standard, Deep)|"At the end of the procedure the surgeon responds to the following question, using an 11-point scale from 0 (poor, unacceptable insufflation pressure, required intervention) to 10 (excellent): How do you rate the overall adequacy of insufflation pressure during the surgery you just performed?"|End of surgery (Day 1)|Randomized participants with available data who had NMB and pneumoperitoneum for laparoscopic surgery, and did not convert to open surgery before NMB and/or pressure application. Participants were included in the treatment arm to which they were randomized.||score on a scale||95% Confidence Interval|Least Squares Mean
668271|NCT01728584|Secondary|Score on Surgeon's Assessment of the Overall Adequacy of Muscle Relaxation During Surgery: By Depth of NMB (Standard, Deep)|"At the end of the procedure the surgeon responds to the following question, using an 11-point scale from 0 (poor, unacceptable muscle relaxation, required intervention) to 10 (excellent): How do you rate the overall adequacy of muscle relaxation during the surgery you just performed?"|End of surgery (Day 1)|Randomized participants with available data who had NMB and pneumoperitoneum for laparoscopic surgery, and did not convert to open surgery before NMB and/or pressure application. Participants were included in the treatment arm to which they were randomized.||score on a scale||95% Confidence Interval|Least Squares Mean
668272|NCT01728584|Secondary|Score on Surgeon's Assessment of Overall Satisfaction With the Visibility of the Surgical Field: By Depth of NMB (Standard, Deep)|"At the end of the procedure the surgeon responds to the following question, using an 11-point scale from 0 (poor, unacceptable visibility) to 10 (excellent): How satisfied were you overall with the visual field during the surgery you just performed? If at any time the surgeon requests a rescue intervention, the surgeon will rate his overall satisfaction with the visibility of the surgical field according to his opinion, but if a rescue intervention has been applied, that individual participant will be counted with a score of zero in the analysis."|End of surgery (Day 1)|Randomized participants with available data who had NMB and pneumoperitoneum for laparoscopic surgery, and did not convert to open surgery before NMB and/or pressure application. Participants were included in the treatment arm to which they were randomized.||score on a scale||95% Confidence Interval|Least Squares Mean
668273|NCT01728584|Secondary|Participant's Overall Average Pain Score in the First 24 Hours After Administration of Sugammadex: By Treatment Arm|Participants rated pain at 1, 2, 4, 24 and 48 hours after the administration of sugammadex on day of surgery (Day 1), and daily from Day 3 to Day 8. Pain rating was made using an 11-point scale from 0 (no pain) to 10 (severe pain). Separate ratings were made for overall pain at rest, pain when provoked (e.g., due to participant transition from lying to sitting position) and shoulder pain at rest. The participant’s overall average pain score within 24 hours after sugammadex was the average of all pain assessments (including all 3 pain types assessed) at 1, 2, 4 and 24 hours after sugammadex dose.|Up to 24 hours after administration of sugammadex on Day 1|Randomized participants with available data who had NMB or pneumoperitoneum for laparoscopic surgery, or received sugammadex, and did not convert to open surgery before NMB and/or pressure. Participants were included in arm corresponding to treatment actually received, which in case of rescue intervention was the post-intervention condition.||score on a scale||95% Confidence Interval|Least Squares Mean
668274|NCT01728584|Secondary|Participant's Overall Average Pain Score in the First 24 Hours After Administration of Sugammadex: By Depth of NMB (Standard, Deep) and Insufflation Pressure (Standard, Low)|Participants rated pain at 1, 2, 4, 24 and 48 hours after the administration of sugammadex on day of surgery (Day 1), and daily from Day 3 to Day 8. Pain rating was made using an 11-point scale from 0 (no pain) to 10 (severe pain). Separate ratings were made for overall pain at rest, pain when provoked (e.g., due to participant transition from lying to sitting position) and shoulder pain at rest. The participant’s overall average pain score within 24 hours after sugammadex was the average of all pain assessments (including all 3 pain types assessed) at 1, 2, 4 and 24 hours after sugammadex dose.|Up to 24 hours after administration of sugammadex on Day 1|Randomized participants with available data who had NMB or pneumoperitoneum for laparoscopic surgery, or received sugammadex, and did not convert to open surgery before NMB and/or pressure. Participants were included in arm corresponding to treatment actually received, which in case of rescue intervention was the post-intervention condition.||score on a scale||95% Confidence Interval|Least Squares Mean
668275|NCT01728584|Primary|Score on Surgeon's Assessment of Overall Satisfaction With the Surgical Conditions: By Treatment Arm|"At the end of the procedure the surgeon responds to the following question, using an 11-point scale from 0 (poor, needed intervention) to 10 (excellent): How satisfied were you overall with the surgical conditions related to anesthesia and pneumoperitoneum during the surgery you just performed? If at any time the surgeon requests a rescue intervention, the overall assessment of surgical conditions should be rated as 0 (=poor, needed intervention). The surgeon will rate the surgical conditions according to his opinion but if a rescue intervention has been applied, that individual participant will be counted with a score of zero in the analysis."|End of surgery (Day 1)|Randomized participants with available data who had NMB and pneumoperitoneum for laparoscopic surgery, and did not convert to open surgery before NMB and/or pressure application. Participants were included in the treatment arm to which they were randomized.||score on a acale||95% Confidence Interval|Least Squares Mean
668276|NCT01728584|Primary|Score on Surgeon's Assessment of Overall Satisfaction With the Surgical Conditions: By Depth of NMB (Standard, Deep) and Insufflation Pressure (Standard, Low)|"At the end of the procedure the surgeon responds to the following question, using an 11-point scale from 0 (poor, needed intervention) to 10 (excellent): How satisfied were you overall with the surgical conditions related to anesthesia and pneumoperitoneum during the surgery you just performed? If at any time the surgeon requests a rescue intervention, the overall assessment of surgical conditions should be rated as 0 (=poor, needed intervention). The surgeon will rate the surgical conditions according to his opinion but if a rescue intervention has been applied, that individual participant will be counted with a score of zero in the analysis."|End of surgery (Day 1)|Randomized participants with available data who had NMB and pneumoperitoneum for laparoscopic surgery, and did not convert to open surgery before NMB and/or pressure application. Participants were included in the treatment arm to which they were randomized.||score on a scale||95% Confidence Interval|Least Squares Mean
668277|NCT01728376|Secondary|Maximum Plasma Concentration (Cmax) of Daptomycin|Plasma concentrations of daptomycin were measured on Days 3 through 6 of IV dosing. Peak concentrations were collected up to 15 minutes following the end of infusion. Concentrations below the limit of quantification were excluded.|Days 3, 4, 5 or 6 of treatment at end of infusion|Participants treated with daptomycin with at least one peak sample. Participants in the comparator treatment groups were not analyzed as they were not treated with daptomycin.||µg/mL||Standard Deviation|Mean
668278|NCT01728376|Secondary|Trough Plasma Concentration of Daptomycin|Plasma concentrations of daptomycin were measured on Days 3 through 6 of IV dosing. Trough concentrations were collected 22 to 26 hours following the end of the previous day’s end of infusion and before the next infusion. Concentrations below the limit of quantification were excluded.|Days 3, 4, 5 or 6 of treatment at pre-dose|Participants treated with daptomycin with at least one trough sample. Participants in the comparator treatment groups were not analyzed as they were not treated with daptomycin.||µg/mL||Standard Deviation|Mean
668293|NCT01728246|Primary|Time to Discontinuation Because of Rescue Medication|Rescue medications are medicines that may be administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation.|Baseline up to Week 4|Time to discontinuation because of rescue medication was not analyzed, because dates when the rescue medication was given were not properly filled out in the forms, hence the exact time to discontinuation because of rescue medication could not be determined or analyzed.|||||
668279|NCT01728376|Secondary|Percentage of Participants With Overall Success at TOC Visit|Overall success is based on microbiologic responses after initiating study drug and clinical response at TOC/Safety Visit. Overall outcome is a success if both clinical and microbiologic outcomes are successes. An assessment of cure or improved is considered clinical success. Microbiological Success: a participant for whom all baseline infecting pathogens were eradicated (presumed or documented) within 7 days from the start of study drug for uncomplicated bacteremia with no source of infection present, and 10 days for complicated bacteremia or when the source of infection has not been removed.|7-14 days after the last dose of study medication (up to 56 days)|All randomized and treated participants who received ≥1 dose of study drug and who had proven S. aureus bacteremia at baseline.||Percentage of participants|||Number
668280|NCT01728376|Secondary|Percentage of Participants With Clinical Success at TOC/Safety Visit|Clinical success was determined by assessing resolution/improvement of signs and symptoms. An assessment of cure or improved is considered clinical success. Cure: resolution of clinically significant signs and symptoms associated with admission infection; no further antibiotic therapy is required for the primary infection under study. Improvement: partial resolution of clinical signs/symptoms of infection such that no further antibiotic therapy is required for the primary infection under study.|7-14 days after the last dose of study medication (up to 56 days)|All randomized and treated participants who received ≥1 dose of study drug and who had proven S. aureus bacteremia at baseline.||Percentage of participants|||Number
668281|NCT01728376|Primary|Number of Participants With Abnormal Focused (Peripheral) Neurological Assessments at Test of Cure (TOC)|Focused neurological examinations were done at the TOC/Safety Visit. These examinations include assessments of sensation, pupillary reflex and tracking, peripheral reflexes (biceps, patellar tendon, ankle jerk and plantar response), muscle tone and strength (upper and lower limbs), coordination (finger to nose) and tremor of the hands/fingers.|TOC Safety Visit (up to 56 days)|Participants who received any dose of IV study medication.||Participants|||Number
668282|NCT01728376|Primary|Percentage of Participants With Sustained CPK Elevations|Blood was drawn from baseline up to the end of therapy visit to determine the percentage of participants with sustained CPK elevations, defined as two consecutive post-baseline values above the upper limit of normal (ULN)|Baseline up to end of therapy visit (up to 44 days)|Participants who received any dose of IV study medication||Percentage of Participants|||Number
668283|NCT01728376|Primary|Percentage of Participants With Maximum Post-Baseline Creatine Phosphokinase (CPK) Elevations Above Upper Limit of Normal|Blood was drawn from baseline up to the end of therapy visit to determine the percentage of participants with maximum post-baseline CPK elevations above the upper limit of 500 Units Per Liter (U/L) .|Baseline up to end of therapy visit (up to 49 days)|Participants who received any dose of IV study medication||Percentage of Participants|||Number
668284|NCT01728376|Primary|Number of Participants With One or More Serious Adverse Events (SAEs)|An SAE is any adverse experience occurring at any dose that results in any of the following outcomes: death, life threatening experience, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is considered to be an important medical event.|Administration of first dose through the last follow-up visit (up to 77 days)|Participants who received any dose of IV study medication||Participants|||Number
668285|NCT01728376|Primary|Number of Participants With One or More Adverse Events (AEs)|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.|Administration of first dose through the last follow-up visit (up to 77 days)|Participants who received any dose of IV study medication||Participants|||Number
668286|NCT01728337|Secondary|Maximum Evoked Compound Muscle Action Potential|To evaluate the duration, magnitude and peak of effects of two BT-A preparations, by measuring of the maximum Evoked Compound Muscle Action Potentials after contraction.|5 months after the procedure.|All subjects have received both treatments.||mV||Standard Deviation|Mean
668287|NCT01728337|Primary|Percentage of Responders After 5 Months After the Procedure|Percentage (%) of responders, after 5 months of injection, to the effects of two botulinum toxin type A (BT-A), Dysport® and Xeomin®. Responders were defined as individuals who presented at least 1 score less in the Wrinkles Scale Score at maximum contraction compared to the WSS score at baseline.|5 months after intervention|80 sujbects were included in this study, each patient have received both products in their faces. The randomization was performed to define the side for each product.||percentage of participants|||Number
668288|NCT01728324|Secondary|Prognostic Value of SVR12 Predicting SVR24|The positive predictive value of SVR12 predicting SVR24 are the patients with an SVR12 (=YES) and the SVR24 was assessed.|24 Week (post-treatment)|FAS||Percentage of participants|||Number
668289|NCT01728324|Secondary|SVR24: Plasma HCV RNA Level <25 IU/mL at 24 Weeks After EOT.|Sustained Virologic Response rates across treatment arms at Week 24 post-treatment (SVR24): Plasma HCV RNA level <25 IU/mL at 24 weeks after EOT.|4 weeks (after End Of Treatment)|FAS||percentage of participants||95% Confidence Interval|Number
668290|NCT01728324|Secondary|SVR4: Plasma HCV RNA Level <25 IU/mL at 4 Weeks After EOT.|Sustained Virologic Response rates across treatment arms at Week 4 post-treatment (SVR4): Plasma HCV RNA level <25 IU/mL at 4 weeks after EOT.|4 weeks (after End Of Treatment)|FAS||percentage of participants||95% Confidence Interval|Number
668291|NCT01728324|Primary|Comparisons of SVR12 Rates Across Treatment Arms|Sustained Virologic Response rates across treatment arms at Week 12 post-treatment (SVR12). This is the secondary analyses of the primary endpoint.|12 Week (post-treatment)|FAS||Percentage of participants||95% Confidence Interval|Number
668292|NCT01728324|Primary|SVR12 Rates With Historical Control|"Sustained Virologic Response at Week 12 post-treatment (SVR12): Plasma Hepatitis C virus (HCV) RNA level <25 IU/mL at 12 weeks after end of Treatment (EOT). SVR12, was assessed based on the observed HCV RNA result taken at least 10 weeks after treatment discontinuation. This definition was also applied to patients who discontinued treatment early: if the patient had HCV RNA undetected at least 10 weeks after stopping all treatment, they were considered a responder in the primary analysis. This is the primary analyses of the primary endpoint.
The number of participants analyzed are actually adjusted number of participant analyzed."|12 Week (post-treatment)|Modified full analysis set (mFAS): included patients in the full analysis set (FAS) who received at least one dose of active treatment;||percentage of participants|||Number
668294|NCT01728246|Primary|Percentage of Participants Who Discontinued Because of Rescue Medication|Rescue medications are medicines that may be administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation.|Baseline up to Week 4|ITT population included all the participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy assessment.||percentage of participants|||Number
668295|NCT01728246|Primary|Change From Baseline in ODI Score at Week 4|The ODI is a low back pain-specific, validated instrument that consists of questions related to limitations in performing specific activities of daily living and 1 question related to pain intensity. The ODI is a self-administered questionnaire that is usually completed in less than 5 minutes. The ODI consists of 10 sections. Each section consists of 6 statements ranked from 0 to 5 (0=good to 5=worse). A higher score represents greater disability.|Baseline and Week 4 (LOCF)|ITT population included all the participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy assessment. LOCF method was used.||units on a scale||Standard Deviation|Mean
668296|NCT01728246|Primary|Change From Baseline in Oswestry Disability Index (ODI) Score at Week 2|The ODI is a low back pain-specific, validated instrument that consists of questions related to limitations in performing specific activities of daily living and 1 question related to pain intensity. The ODI is a self-administered questionnaire that is usually completed in less than 5 minutes. The ODI consists of 10 sections. Each section consists of 6 statements ranked from 0 to 5 (0=good to 5=worse). A higher score represents greater disability.|Baseline and Week 2|Data was not analyzed at Week 2 as time frame was too short to assess Quality of Life (QOL) by ODI score.|||||
668297|NCT01728246|Primary|Change From Baseline in VAS-pain Score at Week 4|VAS is a 100 mm scale. Intensity of pain range: 0 mm=no pain to 100 mm=worst possible pain. Change=scores at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Baseline and Week 4 Last Observation Carried Forward (LOCF)|ITT population included all the participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy assessment. LOCF method was used.||mm||Standard Deviation|Mean
668298|NCT01728246|Primary|Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) Score at Week 2|VAS is a 100 millimeter (mm) scale. Intensity of pain range: 0 mm=no pain to 100 mm=worst possible pain. Change=scores at observation minus score at baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Baseline and Week 2|Intent-to-treat (ITT) population included all the participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy assessment.||mm||Standard Deviation|Mean
668299|NCT01728116|Secondary|Percentage of Subjects Who Achieve % Total Body Weight Loss Greater Than or Equal to 5% at 12 Months||Baseline and 12 Months|mITT population without imputation||percentage of participants|||Number
668300|NCT01728116|Secondary|Diastolic BP Change From Baseline||Baseline and 12 Months|mITT population without imputation||mmHg||Standard Deviation|Mean
668301|NCT01728116|Secondary|Systolic BP Change From Baseline||Baseline and 12 Months|mITT population without imputation||mmHg||Standard Deviation|Mean
668302|NCT01728116|Secondary|Fasting Glucose Change From Baseline||Baseline and 12 Months|mITT population without imputation||mg/dL||Standard Deviation|Mean
668303|NCT01728116|Secondary|Triglycerides Change From Baseline||Baseline and 12 Months|mITT population without imputation||mg/dL||Standard Deviation|Mean
668304|NCT01728116|Secondary|LDL Change From Baseline||Baseline and 12 Months|mITT without imputation||mg/dL||Standard Deviation|Mean
668305|NCT01728116|Secondary|Percentage of Subjects Who Achieve HbA1c Less Than or Equal to 7.0% at 12 Months||Baseline and 12 Months|mITT population without imputation||percentage of participants|||Number
668306|NCT01728116|Secondary|Assessment of Total Cholesterol Change at 12 Months Compared to Baseline||Baseline and 12 Months|mITT population without imputation||mg/dL||Standard Deviation|Mean
668307|NCT01728116|Primary|Primary Safety Endpoint: Early Device Removal Due to Device-Related SAE|Of the 161 subjects for whom data were available at 12 Months, 19 (11.8%) subjects experienced device-related SAEs that required an early device removal.|Baseline and 12 Months|mITT without Imputation||percentage of participants||95% Confidence Interval|Number
668308|NCT01728116|Primary|Primary Efficacy Endpoint: Improvement in HbA1c|Mean Change in HbA1c from Baseline to 12 Months in the mITT population with Bayesian Imputation|Baseline and12 months|All randomized subjects who at their baseline endoscopy are judged to be potential recipients of the device (meaning no abnormal pathologies and/or conditions are present). Any subject who has a device enter their body, regardless of eligibility or randomization assignment, is also included in the treatment arm of the mITT population.||Percentage of HbA1c||Standard Deviation|Mean
668309|NCT01728077|Secondary|50 % Responder Rate in Partial-Onset-Seizure (POS) Type I Frequency From Baseline of the Previous Study to the Evaluation Period for Subjects With Focal-onset Epilepsy Entering N01372 From a Study Where Baseline Seizure Data Was Collected|The POS frequency is standardized to a 28-day duration. A responder is defined as a subject with a >=50% reduction in seizure frequency from the Baseline Period of the previous study. Results are presented as the percentage of subjects with 50 % responder rate in POS Type I frequency.|From Baseline of the previous study to the Last Evaluation Period Visit or Early Discontinuation Visit (up to 49 months)|The analysis was performed on the Efficacy Analysis Set (EAS), which consisted of subjects who took at least one dose of study drug and had at least one seizure daily record card (DRC) day during the Evaluation Period.||percentage of subjects|||Number
668310|NCT01728077|Secondary|Percentage of Change in Partial-Onset-Seizure (POS) Type I Frequency Per 28 Days From Baseline of the Previous Study to the Evaluation Period for Subjects With Focal-onset Epilepsy Entering N01372 From a Study Where Baseline Seizure Data Was Collected|The POS frequency is standardized to a 28-day duration. Results are presented as the median percentage of reduction per 28 days. Negative values indicate improvement from Baseline.|From Baseline of the previous study to the Last Evaluation Period Visit or Early Discontinuation Visit (up to 49 months)|The analysis was performed on the Efficacy Analysis Set (EAS), which consisted of subjects who took at least one dose of study drug and had at least one seizure daily record card (DRC) day during the Evaluation Period.||percentage of change||Full Range|Median
668311|NCT01728077|Secondary|Frequency of Partial-Onset Seizure (POS) Type I Per 28 Days During the Evaluation Period for Subjects With Focal-onset Epilepsy|The POS frequency is standardized to a 28-day duration. Results are presented as the median number of seizures per 28 days.|From Entry Visit (Month 0) to the Last Evaluation Period Visit or Early Discontinuation Visit (up to 46 months)|The analysis was performed on the Efficacy Analysis Set (EAS), which consisted of subjects who took at least one dose of study drug and had at least one seizure daily record card (DRC) day during the Evaluation Period.||Seizures per 28 days||Full Range|Median
668312|NCT01728077|Primary|Occurrence of a Serious Adverse Event (SAE) During the Evaluation Period|SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity or are a congenital anomaly/birth defects. Results are presented as the percentage of subjects with at least one SAE during this study.|From Entry Visit (Month 0) to the Last Evaluation Period Visit or Early Discontinuation Visit (up to 46 months)|The analysis was performed on the Safety Set (SS), which consisted of all subjects who took at least 1 dose of study drug.||percentage of subjects|||Number
668313|NCT01728077|Primary|Percentage of Subjects Withdrawn Due to an Adverse Event (AE) During the Evaluation Period|An AE was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. Results are presented as the percentage of subjects withdrawn due to an AE.|From Entry Visit (Month 0) to the Last Evaluation Period Visit or Early Discontinuation Visit (up to 46 months)|||percentage of subjects|||Number
668314|NCT01728077|Primary|Incidence of Treatment Emergent Adverse Events (TEAEs) During Evaluation Period|TEAEs were defined as AEs that had onset on or after the day of first study medication dose. An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. Results are presented as the percentage of subjects with at least one treatment-emergent adverse event during this study.|From Entry Visit (Month 0) to the Last Evaluation Period Visit or Early Discontinuation Visit (up to 46 months)|||percentage of subjects|||Number
668315|NCT01727895|Secondary|the Composition of Faecal Microbiota||Days 0, 6, 21||||||
668316|NCT01727895|Secondary|• the Leukocyte Capacity to Phagocytose and Kill the Fungal Pathogen Candida Albicans (Antifungal Activity).||Days 0, 6, 21||||||
668317|NCT01727895|Secondary|• Changes in Phenotype and Gene Expression Caused by Mechanisms Other Than Changes in the Underlying DNA Sequence (Epigenetic Modifications)||Days 0, 6, 21||||||
668318|NCT01727895|Secondary|• Transcriptional Pathways (by Use of Microarrays) With Focus on Inflammatory Pathways.||Days 0, 6, 21||||||
668319|NCT01727895|Secondary|• the Absorbance of Orally Administered Beta-glucan Into the Blood Compartment, Measured by ELISA||Days 0, 6, 21||||||
668320|NCT01727895|Secondary|• Production of Other Cytokines (TNF-α, Interleukin (IL)-6, IL-10, IL-1β, IL-17, IL-22, Interferon (IFN)-γ) by Leukocytes ex Vivo Stimulated With Various Stimuli (Including LPS, Pam3Cys, Mycobacterium Tuberculosis, Poly(I:C), Candida, Staph Aureus)||days 0, 6, 21||||||
668321|NCT01727895|Primary|Tumor Necrosis Factor (TNF)-α Secretion by ex Vivo Lipopolysaccharide (LPS)-Stimulated Peripheral Blood Mononuclear Cells (PBMCs)|The primary objective of the study is to evaluate the systemic effects of orally administered Beta-glucan on innate immune responses of leukocytes. The effects of Beta-glucan will be determined by measuring the ex vivo responsiveness of leukocytes to various inflammatory stimuli as a surrogate marker of the antimicrobial response|up to 21 days|||pg/ml||Inter-Quartile Range|Median
668322|NCT01727791|Other Pre-specified|Number of Participants With Clinically Significant Change From Baseline in Vital Signs|The following parameters were analyzed for examination of vital signs: electrocardiogram (ECG), systolic and diastolic blood pressure, temperature, pulse rate, respiratory rate, radial pulse and body temperature.|Baseline up to 28 days after last dose of study drug|The safety analysis population included participants who received at least 1 dose of study medication.||participants|||Number
668323|NCT01727791|Other Pre-specified|Number of Participants With Laboratory Abnormalities|The following parameters were analyzed for laboratory abnormalities: hematology (hemoglobin, hematocrit, red blood cell count, mean corpuscular volume [MCV], mean corpuscular hemoglobin [MCH], mean corpuscular hemoglobin concentration [MCHC], platelets, white blood cell count, lymphocytes, total neutrophils, basophils, eosinophils, monocytes); liver function (bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, total protein, albumin); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (sodium, potassium, chloride, calcium, bicarbonate); clinical chemistry (glucose); urinalysis (urine pH, glucose, ketones, protein, urine blood/hemoglobin, nitrite).|Baseline up to 28 days after last dose of study drug|The safety analysis population included participants who received at least 1 dose of study medication.||participants|||Number
668324|NCT01727791|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs.|Baseline up to 28 days after last dose of study drug|The safety analysis population included participants who received at least 1 dose of study medication.||participants|||Number
668325|NCT01727791|Primary|Infant Dose Expressed as Percentage of Body Weight Normalized Maternal Dose (BWNIDPCM)|Infant dose expressed as percentage of body weight normalized maternal dose (BWNIDPCM) was the relative infant dose (relative to maternal dose) calculated by the formula: 100 * BWNID (Body Weight Normalized Infant Dose) / Body Weight Normalized Maternal Dose (BWNMD), where tau was the dosing interval of 12 hours.|Pre-dose to 24 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.||percentage of dose||Full Range|Mean
668411|NCT01726517|Primary|Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)|The number of participants experiencing an adverse event leading to permanent discontinuation of study drug(s) was summarized.|Baseline to Week 12|Safety Analysis Set||participants|||Number
668326|NCT01727791|Primary|Body Weight Normalized Maternal Dose (BWNMD)|Body weight normalized maternal dose (BWNMD) was calculated as the maternal dose in microgram per day (mcg/day) divided by maternal weight in kilogram (kg) at screening.|Pre-dose to 24 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.||mcg/kg/day||Full Range|Mean
668327|NCT01727791|Primary|Body Weight Normalized Infant Dose (BWNID)|Body weight normalized infant dose (BWNID) of pregabalin was the dose that an infant received from breast-feeding and was calculated from the milk to plasma AUCtau ratio multiplied by the average maternal plasma pregabalin concentration (Cav) multiplied by the standardized milk consumption for an infant (150 milliliter/kilogram/day [mL/kg/day]), where tau was the dosing interval of 12 hours.|Plasma: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12 hours post-dose on Day 3. Breast milk: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.||mcg/kg/day||Full Range|Mean
668328|NCT01727791|Primary|Milk to Plasma Ratio for Maximum Observed Concentration (MPCmax)|Milk to plasma ratio for maximum observed concentration (MPCmax) was calculated as the ratio of Cmax (breast milk) to Cmax (plasma).|Plasma: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12, 18, 24 hours post-dose on Day 3. Breast milk: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.||ratio||Full Range|Mean
668329|NCT01727791|Primary|Milk to Plasma Ratio for AUCtau (MPAUCtau)|MPAUCtau was the ratio of AUCtau (breast milk) to AUCtau (plasma), where tau was the dosing interval of 12 hours.|Plasma: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12 hours post-dose on Day 3. Breast milk: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.||ratio||Full Range|Mean
668330|NCT01727791|Primary|Daily Amount of Pregabalin Excreted in Breast Milk (Ae24bm)|Ae24bm was the daily amount of pregabalin excreted in breast milk. It was calculated by the formula: 2 * Aetaubm (sum of [breast milk concentration * sample volume] for each collection interval from 0 to 12 hours post-dose), where tau was the dosing interval of 12 hours.|Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.||mcg||Full Range|Mean
668331|NCT01727791|Primary|Renal Clearance (CLr)|Renal clearance (CLr) was the volume of plasma from which the drug was completely removed by the kidney in a given amount of time. It was calculated by dividing Aetauurine (sum of [urine concentration * sample volume] for each collection interval from 0 to 12 hours post-dose) with the plasma AUCtau, where tau was the dosing interval of 12 hours.|Plasma: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12 hours post-dose on Day 3. Urine: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8 and 8 to 12 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.||mL/min||Geometric Coefficient of Variation|Geometric Mean
668332|NCT01727791|Primary|Percent of Dose Recovered in Urine During the Dosing Interval Tau (Aetauurine Percent)|Percent of dose recovered in urine during the dosing interval tau (Aetauurine percent) was calculated as 100* (Aetau [sum of {urine concentration * sample volume} for each collection interval from 0 to 12 hours post-dose] divided by the dose), where tau was the dosing interval of 12 hours.|Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.||percentage of dose||Geometric Coefficient of Variation|Geometric Mean
668333|NCT01727791|Primary|Amount Recovered in Urine During the Dosing Interval Tau (Aetauurine)|Aetauurine was the amount excreted in urine over the dosing interval tau (12 hours). It was calculated as the sum of (urine concentration * sample volume) for each collection interval from 0 to 12 hours post-dose, where tau was the dosing interval of 12 hours. Here, sample volume was based on the ratio of volume weight and density.|Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.||mg||Geometric Coefficient of Variation|Geometric Mean
668334|NCT01727791|Primary|Breast Milk Clearance (CLbm)|Breast milk clearance (CLbm) was calculated by dividing Aetaubm (sum of [breast milk concentration * sample volume] for each collection interval from 0 to 12 hours post-dose) by plasma AUCtau, where tau was the dosing interval of 12 hours.|Plasma: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12 hours post-dose on Day 3. Breast milk: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.||mL/min||Geometric Coefficient of Variation|Geometric Mean
668335|NCT01727791|Primary|Percentage of Dose Excreted in Breast Milk During the Dosing Interval Tau (Aetaubm Percent)|Percentage of dose excreted in breast milk during the dosing interval tau (Aetaubm percent) was calculated by using the formula: 100*(Aetaubm [sum of {breast milk concentration * sample volume} for each collection interval from 0 to 12 hours post-dose] divided by dose), where tau was the dosing interval of 12 hours.|Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.||percentage of dose||Geometric Coefficient of Variation|Geometric Mean
668336|NCT01727791|Primary|Amount Excreted in Breast Milk Over the Dosing Interval Tau (Aetaubm)|Aetaubm was the amount excreted in breast milk over the dosing interval tau (12 hours). It was calculated as the sum of (breast milk concentration * sample volume) for each collection interval from 0 to 12 hours post-dose, where tau was the dosing interval of 12 hours. Sample volume was based on ratio of volume weight and density.|Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.||mcg||Geometric Coefficient of Variation|Geometric Mean
668731|NCT01721096|Secondary|Target Vessel Revascularization (Non-TLR)|Target vessel revascularization (TVR) includes ischemia driven TVR, non-TLR and non- ischemia driven TVR, non-TLR|1 year post index procedure|||percentage of participants|||Number
668337|NCT01727791|Primary|Average Breast Milk Concentration During the Dosing Interval (Cav)|Average breast milk concentration during the dosing interval (Cav) was calculated by dividing AUCtau (breast milk) with tau, where tau was the dosing interval of 12 hours.|Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.||mcg/mL||Full Range|Mean
668338|NCT01727791|Primary|Terminal Half-Life for Breast Milk (t1/2 [Breast Milk])|The terminal half-life for breast milk (t1/2 [breast milk]) was the time measured for breast milk concentration to decrease by one-half. For the first 5 participants enrolled under protocol amendment dated: 18 Sep 2012, breast milk was collected up to 24 hours after Day 3 dosing over the following time intervals: 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24 hours. Terminal half-life was determined over those points characterizing the elimination phase. For the remaining 5 participants, there were 3 additional collection intervals (24 to 32, 32 to 40, 40 to 48 hours) for characterizing the terminal elimination phase. The t1/2 (breast milk) is based on the terminal elimination phase time points from this timeframe.|Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.||hr||Standard Deviation|Mean
668339|NCT01727791|Primary|Time to Reach Maximum Observed Breast Milk Concentration (Tmax [Breast Milk])|Tmax (breast milk) was time of the maximum observed breast milk concentration Day 3 post-dose.|Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.||hr||Full Range|Median
668340|NCT01727791|Primary|Maximum Observed Concentration in Breast Milk (Cmax [Breast Milk])|Cmax (breast milk) was the maximum observed concentration in breast milk post Day 3 dose.|Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
668341|NCT01727791|Primary|Area Under the Curve From Time Zero to End of Dosing Interval for Breast Milk (AUCtau [Breast Milk])|AUCtau (breast milk) was the area under the curve for breast milk, from time 0 to tau (AUCtau), where tau was the dosing interval of 12 hours.|Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.||mcg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
668342|NCT01727791|Primary|Apparent Oral Clearance (CL/F)|Apparent oral clearance (CL/F) was calculated by dividing dose by the AUCtau, where tau was the dosing interval of 12 hours. Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.||mL/minute||Geometric Coefficient of Variation|Geometric Mean
668343|NCT01727791|Primary|Minimum Observed Plasma Trough Concentration (Cmin)|Cmin was the minimum observed plasma concentration of a drug after post Day 3 dose.|Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12, 18, 24 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
668344|NCT01727791|Primary|Average Plasma Concentration During the Dosing Interval (Cav)|Average plasma concentration during the dosing interval (Cav) was calculated by dividing AUCtau (plasma) with tau, where tau was the dosing interval of 12 hours.|Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
668345|NCT01727791|Primary|Plasma Half-Life (t1/2)|Plasma decay half-life (t1/2) was the time for the plasma concentration to decrease by one-half. The t1/2 is based on the terminal elimination phase time points from this timeframe.|Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12, 18, 24 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.||hr||Standard Deviation|Mean
668346|NCT01727791|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax)|Tmax was the time to peak concentration in plasma post Day 3 dose.|Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12, 18, 24 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.||hr||Full Range|Median
668347|NCT01727791|Primary|Maximum Observed Plasma Concentration (Cmax)|Cmax was the peak concentration in plasma post Day 3 dose.|Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12, 18, 24 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
668348|NCT01727791|Primary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)|Area under the plasma concentration-time profile from time 0 to tau (AUCtau), where tau was the dosing interval of 12 hours.|Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12 hours post-dose on Day 3|The pharmacokinetic (PK) parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.||microgram*hour/milliliter (mcg*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
668349|NCT01727713|Secondary|Percentage of Participants With Treatment Discontinuation (Treatment Discontinuation Rate).|The treatment discontinuation rate was calculated as the number of discontinued participants (ie, those withdrawn from the study without completing the Week 52 visit) divided by the number of all enrolled participants.|Baseline to Week 52|All participants who receive at least 1 dose of open-label study drug in this trial, and have baseline and at least 1 post-baseline efficacy evaluation.||Percentage of discontinued participants|||Number
677822|NCT01605292|Secondary|First-pass Success Rate|Proportion of procedures achieving access on the first attempt|Immediate|Subgroup of patients with accurate number of attempts measured||participants|||Number
668350|NCT01727713|Secondary|Percentage of Participants With Response (Response Rate).|Clinical response was defined as > 25% improvement from Baseline to endpoint in YGTSS TTS or a CGI-TS change score of 1 (very much improved) or 2 (much improved) at endpoint.|Weeks 4, 8, 12, 20, 28, 36, 44 and 52|All participants who receive at least 1 dose of open-label study drug in this trial, and have baseline and at least 1 post-baseline efficacy evaluation.||Percentage of participants with response|||Number
668351|NCT01727713|Secondary|Mean Change From Baseline to Endpoint in Total YGTSS Score.|The YGTSS consists of a tic inventory, with 5 separate rating scales to rate the severity of symptoms (on a scale of 0 to 5 for 5 different dimensions, including number, frequency, intensity, complexity, and interference) for motor and vocal tics, and an impairment ranking. The YGTSS TTS is the summation of the severity scores of motor and vocal tics (range of 0 [no impairment] to 50 [maximum impairment]). The total YGTSS score is the summation of the severity scores of motor and vocal tics and the ranking of impairment (total range of 0 [no impairment] to 100 [maximum impairment]).|Baseline to Week 52|All participants who receive at least 1 dose of open-label study drug in this trial, and have baseline and at least 1 post-baseline efficacy evaluation.||Units on a scale||Standard Deviation|Mean
668352|NCT01727713|Secondary|Change From Baseline to Endpoint in CGI-TS Severity of Illness Score.|The final CGI-TS score was compared to the participant’s baseline condition at the time of entry into the open-label study, rather than the CGI-TS baseline condition at the time participants enrolled into the preceding study. Response choices include: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.|Baseline to Week 52|All participants who receive at least 1 dose of open-label study drug in this trial, and have baseline and at least 1 post-baseline efficacy evaluation.||Units on a scale||Standard Deviation|Mean
668353|NCT01727713|Secondary|Mean Clinical Global Impressions for Tourette’s Syndrome (CGI-TS) Change Score at Endpoint.|The CGI is a 7-point Likert scale used in a multitude of clinical trials as a clinical global measure to assess the severity and change in disease symptomatology (ie, tics). The CGI was included as a secondary scale to provide a more complete assessment of clinical efficacy. To assess CGI-TS severity, the rater or investigator will answer the following question: “Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?” However, the evaluation of illness will be limited to manifestations of Tourette’s Disorder only. Response choices include: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill patients.|Baseline to Week 52|All participants who receive at least 1 dose of open-label study drug in this trial, and have baseline and at least 1 post-baseline efficacy evaluation.||Units on a scale||Standard Deviation|Mean
668354|NCT01727713|Secondary|Change From Baseline to Endpoint on the Total Tic Score (TTS) of the Yale Global Tic Severity Scale (YGTSS).|The YGTSS is a semi-structured clinical interview which consists of a tic inventory, with 5 separate ratings to assess the number, intensity, frequency, complexity and interference of tics, plus an overall impairment/disability score. Ratings are made along 5 different dimensions on a scale of 0 to 5 for motor and vocal tics each, including number, frequency, intensity, complexity, and interference. Summation of these 10 scores (ie, 0-50) provides a TTS that was the secondary outcome measure in this trial. The YGTSS ranking of impairment, with a maximum of 50 points, is based on the impact of the tic disorder on areas of self-esteem, family life, social acceptance, and school scores. The total severity score ranged from 0 (no impairment) to 50 (worst impairment).|Baseline to Week 52|All participants who receive at least 1 dose of open-label study drug in this trial, and have baseline and at least 1 post-baseline efficacy evaluation.||Units on a scale||Standard Deviation|Mean
668355|NCT01727713|Primary|Change From Baseline in Pediatric Anxiety Rating Scale (PARS).|The PARS is used to rate the severity of anxiety in children and adolescents, aged 6 to 17 years. The PARS has 2 sections: the symptom checklist and the severity items. The symptom checklist is used to determine the child’s repertoire of symptoms during the past week. The 7-item severity list is used to determine severity of symptoms and the PARS total score. The time frame for the PARS is the past week. Only those symptoms endorsed for the past week are included in the symptom checklist and rated on the severity items. The PARS total severity score was the sum of items 2, 3, 5, 6, and 7. The total severity score ranged from 0 (no anxiety) to 25 (worst anxiety).|Baseline, Weeks 4, 8, 12, 20, 28, 36, 44, 52, and Last visit|Safety Sample: All participants who received at least 1 dose of open-label study drug in this trial.||Units on a scale||Standard Deviation|Mean
668356|NCT01727713|Primary|Change From Baseline in Children’s Depression Rating Scale - Revised (CDRS-R).|The CDRS-R is a brief rating scale based on a semi-structured interview with the child and an adult informant who knows the child well. Designed for 6- to 12-year-old children, and successfully used with adolescents, it can be administered in 15 to 20 minutes. The interviewer rates 17 symptom areas (including those that serve as Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision criteria for a diagnosis of depression): impaired schoolwork, difficulty having fun, social withdrawal, appetite disturbance, sleep disturbance, excessive fatigue, physical complaints, irritability, excessive guilt, low self-esteem, depressed feelings, morbid ideas, suicidal ideas, excessive weeping, depressed facial affect, listless speech, and hypoactivity. The CDRS-R total score is the sum of scores for the 17 symptom areas and could range from 17 to 113 with higher values indicating worse outcome.|Baseline, Weeks 4, 8, 12, 20, 28, 36, 44, 52, and Last visit|Safety Sample: All participants who received at least 1 dose of open-label study drug in this trial.||Units on a scale||Standard Deviation|Mean
668357|NCT01727713|Primary|Change From Baseline in Children’s Yale-Brown Obsessive Compulsive Scale (CY-BOCS).|The CY-BOCS is a semi-structured interview used with children and adolescents aged 6 to 17 years to rate the severity and type of symptoms in participants with obsessive compulsive disorder. In general, the items depend on the participant's report; however, the final rating is based on the clinical judgment of the interviewer and should include additional information supplied by others. Nineteen items are rated in the CY-BOCS, but only items 1 through 10 (excluding items lb and 6b) are used to determine the total score. The total CY-BOCS score is the sum of items 1 through 10 (excluding lb and 6b), whereas the obsession and compulsion subtotals are the sums of items 1 through 5 (excluding lb) and 6 through 10 (excluding 6b), respectively. CY-BOCS total score could range from 0 to 40, and the obsession and compulsion subscale total scores could each range from 0 to 20. Higher scores indicate worse outcome.|Baseline, Weeks 4, 8, 12, 20, 28, 36, 44, 52, and Last visit|Safety Sample: All participants who received at least 1 dose of open-label study drug in this trial.||Units on a scale||Standard Deviation|Mean
668358|NCT01727713|Primary|Change From Baseline in Average Score of Attention Deficit Disorder/Attention-deficit Hyperactivity Disorder (ADD/ADHD) of Swanson, Nolan, and Pelham-IV Rating Scale (SNAP-IV).|The SNAP-IV Rating Scale is a revision of the SNAP Questionnaire. The SNAP-IV assesses inattention and hyperactivity/impulsivity, as well as oppositional defiant disorder that are often present in children with ADD/ADHD. The SNAP-IV was administered as a semi-structured interview with the participant and caregiver. The SNAP-IV is based on a 0 to 3 rating scale: not at all = 0, just a little = 1, quite a bit = 2, and very much = 3. The ADD/ADHD subscale includes items 1 through 19 (items 1–9 measure inattention, items 11–19 measure hyperactivity/ impulsivity, and item 10 for inattention domain), items 4, 8, 11, 31, and 32 measure inattention/overactivity, and items 21, 23, 29, 34, and 35 measure aggression/defiance. Items 4, 8, 11, 21, 32, 33, 36, 37, 38, and 39 form the Conners Index. Subscale average scores on the SNAP IV were calculated by summing the scores on the items in the subset and dividing by the number of items in the subset.|Baseline, Weeks 4, 8, 12, 20, 28, 36, 44, 52, and Last visit|Safety Sample: All participants who received at least 1 dose of open-label study drug in this trial.||Units on a scale||Standard Deviation|Mean
668359|NCT01727713|Primary|Change From Baseline in Suicidal Ideation Intensity Total Score Based on Columbia-Suicide Severity Rating Scale (C-SSRS).|The C-SSRS consists of a baseline evaluation that assesses the lifetime experience of the participant with suicide events and suicidal ideation and a post baseline/“since last visit” evaluation that focuses on suicidality since the last trial visit. The C-SSRS data at Baseline and post baseline were summarized for incidence of reporting: Suicidality, Suicidal behavior (and its 4 types), Suicidal ideation (and its 5 types). The intensity score of each item ranges from 1 (least severe) to 5 (most severe), which leads to the range of the total score from 0 to 25.|Baseline, Weeks 1, 2, 4, 8, 12, 20, 28, 36, 44, 52, and Last visit|Safety Sample: All participants who received at least 1 dose of open-label study drug in this trial.||Units on a scale||Standard Deviation|Mean
668360|NCT01727713|Primary|Change From Baseline in Barnes Akathisia Rating Scale (BARS) Total Score.|The BARS Global Score is derived from the global clinical evaluation of akathisia on a 6-point scale, with 0 representing absence of symptoms and a score of 5 representing severe akathisia.|Baseline, Weeks 4, 8, 12, 20, 28, 36, 44, 52, and Last visit|Safety Sample: All participants who received at least 1 dose of open-label study drug in this trial.||Units on a scale||Standard Deviation|Mean
668361|NCT01727713|Primary|Change From Baseline in Simpson-Angus Scale (SAS) Total Score.|The SAS consists of a list of 10 symptoms of Parkinsonism (gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, head rotation, glabella tap, tremor, salivation, and akathisia). Each item was rated on a 5-point scale, with a score of 1 representing absence of symptoms, and a score of 5 representing a severe condition. The SAS total score (range 10 to 50) was the sum of the rating scores for 10 items from the SAS panel.|Baseline, Weeks 4, 8, 12, 20, 28, 36, 44, 52, and Last visit|Safety Sample: All participants who received at least 1 dose of open-label study drug in this trial.||Units on a scale||Standard Deviation|Mean
668362|NCT01727713|Primary|Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score.|The AIMS assessment consists of 10 items describing symptoms of dyskinesia. Facial and oral movements (items 1 through 4), extremity movements (items 5 and 6), and trunk movements (item 7) were observed unobtrusively while the participant was at rest, and the investigator also made global judgments on the participant's dyskinesias (items 8 through 10). Each item was rated on a 5-point scale, with a score of 0 representing absence of symptoms (for item 10, no awareness), and a score of 4 indicating a severe condition (for item 10, awareness/severe distress). In addition, the AIMS included 2 yes/no questions that addressed the subject’s dental status (since an edentulous state can cause lingual dyskinesias). The AIMS movement rating score (range 0 to 28) was the sum of the rating scores for facial and oral moments (ie, items 1 to 4), extremity movements (ie, items 5 and 6), and trunk movements (ie, item 7).|Baseline, Weeks 4, 8, 12, 20, 28, 36, 44, 52, and Last visit|Safety Sample: All participants who received at least 1 dose of open-label study drug in this trial.||Units on a scale||Standard Deviation|Mean
668363|NCT01727713|Primary|Mean Change From Baseline in Waist Circumference.|Waist circumference was measured at Baseline, Weeks 12, 28, 36, 44, and the Week 52/last visit in centimeters.|Baseline to Weeks 12, 28, 36, 44, and 52/last visit.|Safety Sample: All participants who received at least 1 dose of open-label study drug and who had a least one post-baseline waist circumference measurement.||Centimeter||Standard Deviation|Mean
668364|NCT01727713|Primary|Mean Change From Baseline in Body Mass Index (BMI).|BMI was calculated at the Baseline visit (using the Baseline height from study 31-12-293) and at Weeks 28 and 52/ET where height measured at baseline in the current trial was used to calculate BMI.|Baseline to Weeks 28, 52 and Last visit.|Safety Sample: All participants who received at least 1 dose of open-label study drug and who had a least one post-baseline BMI measurement.||Kg/M^2||Standard Deviation|Mean
668365|NCT01727713|Primary|Mean Change From Baseline in Body Weight.|Criteria for identifying weight of potential clinical relevance was: ≥ 7% kilogram increase/decrease from Baseline (Final visit of Trial 31-12-293).|Baseline to Weeks 12, 28, 36, 44, 52/Last visit.|Safety Sample: All participants who received at least 1 dose of open-label study drug in this trial and who had at least one post-baseline weight measurement.||Kilogram||Standard Deviation|Mean
668366|NCT01727713|Primary|Percentage of Participants With Clinically Significant Abnormal Electrocardiogram (ECG).|Three 12-lead ECGs (scheduled 5 minutes apart) were recorded. Some of the pre-defined criteria for identifying ECG measurements of potential clinical relevance included: Tachycardia/sinus tachycardia: increase of ≥15 bpm from Baseline; increase in QTc of ≥10% from Baseline. The other abnormalities not present at Baseline and were present during the time of measurement were recorded. Percentage of participants noted with abnormal ECG findings are reported below.|Baseline to Week 52|Safety Sample: All participants who received at least 1 dose of open-label study drug in this trial and who who had at least one post-baseline ECG result were included.||Percentage of participants|||Number
668388|NCT01727258|Primary|Mean Tactile Sensitivity Score at Week 4|Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|4 weeks|Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||grams of force||Standard Error|Least Squares Mean
668367|NCT01727713|Primary|Percentage of Participants With Clinically Significant Abnormal Vital Signs.|Vital sign measurements included systolic and diastolic blood pressure (BP) and heart rate, which were performed at all clinic visits. Criteria for identifying vital signs of potential clinical relevance included: Heart rate: ≥ 15 beats per minute (bpm) increase/decrease from Baseline (final visit of study 31-12-293); Systolic BP: ≥ 20 mmHg increase/decrease from Baseline; Diastolic BP: ≥ 15mmHg increase/decrease from Baseline; Orthostatic hypotension: ≥ 20 mmHg decrease in systolic BP and a ≥ 25 bpm increase in heart rate from supine to sitting/standing. Percentage of participants noted with abnormal vital sign measurements are reported below.|Baseline to Week 52|Safety Sample: All participants who received at least 1 dose of open-label study drug in this trial and who who had at least one post-baseline vital sign result were included.||Percentage of participants|||Number
668368|NCT01727713|Primary|Percentage of Participants With Clinically Significant Abnormal Laboratory Test Results.|Laboratory tests including hematology, serum chemistry, and urinalysis were performed for all the participants. The central laboratory was used for all laboratory testing whenever possible. Any value outside the normal range was flagged for the attention of the study physician who was to indicate whether the value was clinically significant based on the pre-defined criteria for identifying laboratory values of potential clinical relevance. Percentage of participants noted with abnormal laboratory values are reported below.|Baseline to Week 52|Safety Sample: All participants who received at least 1 dose of open-label study drug in this trial and who had at least one post-baseline laboratory value were included.||Percentage of participants|||Number
668369|NCT01727713|Primary|Percentage of Participants With Adverse Events.|An AE is defined as any untoward medical occurrence in a patient or participant enrolled in the clinical trial and which does not necessarily have to have a causal relationship with the study drug. A treatment emergent adverse event (TEAE) is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not considered related to have a causal relationship with the study drug. Serious adverse event (SAE) or reaction is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires in-patient hospitalization or prolonged hospitalization, results in persistent or significant disability/incapacity or is a congenital anomaly/birth defect.|Baseline, throighout the 52-week treatmetn and 30±3 days after last trial visit|Safety Sample: All participants who received at least 1 dose of open-label study drug in this trial.||Percentage of participants|||Number
668370|NCT01727700|Secondary|Treatment Discontinuation Rate|Treatment discontinuation rate will be calculated as the number of discontinued participants (ie, those who were withdrawn from the trial without completing the Week 8 visit) over the number of all randomized participants.|Week 8|ITT Population: All participants randomly assigned to the double-blind treatment.||Percentage of participants|||Number
668371|NCT01727700|Secondary|Response Rate|Clinical response is defined as > 25% improvement from baseline to Week 8 in YGTSS TTS or a CGI-TS Change score of 1 [very much improved] or 2 [much improved] at Week 8. Response will be considered as missing only if both YGTSS TTS and CGI-TS change score are missing. As long as one of them is non-missing, response outcome will be determined based on the non-missing score.|Week 8|ITT Population: All participants randomly assigned to the double-blind treatment. At Week 8, data were available for 42 participants in the low dose, 35 in the high dose and 42 in the placebo group.||Percentage of Responders|||Number
668372|NCT01727700|Secondary|Mean Change From Baseline to Endpoint (Week 8) in CGI-TS Severity Score|The CGI-TS Severity scale (range 0-7) is a single-item rating score, with higher scores representing greater severity or less improvement. A response of 0 (not assessed) is considered and handled as missing data.|Baseline to Week 8|ITT Population: All participants randomly assigned to the double-blind treatment. At Week 8, data were available for 42 participants in the low dose, 35 in the high dose and 42 in the placebo group.||Units on a scale||Standard Error|Least Squares Mean
668373|NCT01727700|Secondary|Mean Change From Baseline to Endpoint (Week 8) in Total YGTSS Score|The YGTSS consists of a tic inventory, with 5 separate rating scales to rate the severity of symptoms (on a scale of 0 to 5 for 5 different dimensions, including number, frequency, intensity, complexity, and interference) of motor and vocal tics, and an impairment ranking. The Total YGTSS score is the summation of the severity scores of motor and vocal tics and also the ranking of impairment (range of 0 to 100). A missing value of a YGTSS item scale could result in a missing Total YGTSS score. A reduction in Total YGTSS score from baseline represents an improvement in symptoms.|Baseline to Week 8|ITT Population: All participants randomly assigned to the double-blind treatment. At Week 8, data were available for 42 participants in the low dose, 35 in the high dose and 42 in the placebo group.||Units on a scale||Standard Error|Least Squares Mean
668374|NCT01727700|Secondary|Change in Clinical Global Impressions Scale-Tourette's Syndrome (CGI-TS) Score at Week 8.|To assess CGI-TS severity, the rater or physician answered the following question: “Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?” However, the evaluation of illness was limited to manifestations of TD only. Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill patients. The change score was obtained from CGI-TS improvement scale assessment: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.|Week 8|ITT Population: All participants randomly assigned to the double-blind treatment. At Week 8, data were available for 42 participants in the low dose, 35 in the high dose and 42 in the placebo group.||Units on a scale||Standard Error|Least Squares Mean
668386|NCT01727258|Secondary|Mean Tactile Sensitivity VAS Score at Week 2|Tooth sensitivity was measured using a Visual Analogue Scale (VAS). At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|2 weeks|Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||units on a scale (mm)||Standard Error|Least Squares Mean
668375|NCT01727700|Primary|Change From Baseline to Week 8 in Yale Global Tic Severity Scale (YGTSS) Total Tic Score (TTS).|The YGTSS is a semi-structured clinical interview designed to measure current (time frame of the past 1 week) tic severity. This scale consists of a tic inventory, with 5 separate rating scales to rate the severity of symptoms, and an impairment ranking. Ratings are made along 5 different dimensions on a scale of 0 to 5 for motor and vocal tics each, including number, frequency, intensity, complexity, and interference. Summation of these 10 scores (ie, 0-50) provides a TTS that was the primary outcome measure in this trial. The YGTSS ranking of impairment score rated on a 50-point scale anchored from 0 (no impairment) to 50 (severe impairment) to assess impairment experienced in areas of self-esteem, family life, social acceptance, and school scores. This is a fully validated scale in adults and has become a standard instrument for the evaluation of the severity of TD in children.|Baseline to Week 8|Intent-to-Treat (ITT) Population: All participants randomly assigned to the double-blind treatment. At Week 8, data were available for 42 participants in the low dose, 35 in the high dose and 42 in the placebo group.||Units on a scale||Standard Error|Least Squares Mean
668376|NCT01727505|Other Pre-specified|Tidal Volume|The mean exhaled tidal volume of mechanical breaths.|24 hours|||ml/Kg||Standard Deviation|Mean
668377|NCT01727505|Other Pre-specified|Fraction of Inspired Oxygen (FiO2)|"Calculated as the mean value of the recorded fraction of inspired oxygen for each subject during each of the two 24 hour periods.
Reported as median and inter-quartile range of all subjects."|24 hours|||fraction||Inter-Quartile Range|Median
668378|NCT01727505|Secondary|Duration of Hypoxemia Episodes|Duration of hypoxemia episodes of arterial saturation < 85% for at least 20 seconds. Calculated as the mean episode duration per subject per period. Reported as median and inter-quartile range of all subjects.|24 hours|||seconds||Inter-Quartile Range|Median
668379|NCT01727505|Secondary|Frequency of Hypoxemia Episodes|Frequency of hypoxemia episodes defined as episodes with arterial saturation < 85% for at least 20 seconds|24 hours|||hypoxemia episodes per hour||Inter-Quartile Range|Median
668380|NCT01727505|Secondary|Frequency of Severe Hypoxemia Episodes|Frequency of severe hypoxemia episodes defined as periods with arterial oxygen saturation SpO2 < 75% lasting for at least 20 seconds.|24 hours|||severe hypoxemia episodes per hour||Inter-Quartile Range|Median
668381|NCT01727505|Primary|Percentage of Time Spent With Arterial Oxygen Saturation < 75%|Percentage of time spent with arterial oxygen saturation < 75%|24 hours|||% of time||Inter-Quartile Range|Median
668382|NCT01727414|Primary|ADHD Total Symptom Score|"Assessed via parent and teacher-completed Vanderbilt ADHD Rating Scales which were administered at the end of each the 4 weeks of the titration trial.
Range: 0-54 [sum of 18 symptom items, rated from 0 (none), 1 (occasionally), 2 (often), 3 (very often)], higher scores indicate more ADHD symptoms Note to address Review Comment: During the 4 week titration trial, the placebo condition and each of the three active dosages (low, medium, and high) were given for one week each. Because the placebo and active dosages were given in random order to preserve the triple blind, all participants did not receive the same order of dosages and it is not possible to connect the connect the dosages (placebo, low dose MPH, medium dose MPH, high dose MPH) to a specific week number (week 1, week 2, week 3, week 4) which would hold for ALL participants. That is why Timeframe was revised from week 1, week 2, week 3, week 4 to placebo, low dose, medium dose, and high dose week."|End of placebo dose week, End of low dose week, End of medium dose week , End of high dose week|||units on a scale||Standard Deviation|Mean
668383|NCT01727258|Secondary|Mean Cold Air Stimulus VAS Score at Week 4|Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|4 weeks|Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||units on a scale (mm)||Standard Error|Least Squares Mean
668384|NCT01727258|Secondary|Mean Cold Air Stimulus VAS Score at Week 2|Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|2 weeks|Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||units on a scale (mm)||Standard Error|Least Squares Mean
668385|NCT01727258|Secondary|Mean Tactile Sensitivity VAS Score at Week 4|Tooth sensitivity was measured using a Visual Analogue Scale (VAS). At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|4 weeks|Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||units on a scale (mm)||Standard Error|Least Squares Mean
668387|NCT01727258|Primary|Mean Tactile Sensitivity Score at Week 2|Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|2 weeks|Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||grams of force||Standard Error|Least Squares Mean
678167|NCT01600482|Secondary|Procedure Success|Procedure Success 30 days +/- 7 days|30 days +/- 7 days|7 patients were excluded in Manual Compression group as there was no TTH data recorded.||Number of patients|||Number
668392|NCT01727141|Secondary|Change From Baseline in Mean Total Daily Symptom Score, Mean Daytime Total Symptom Score and Mean Nighttime Total Symptom Score|The participant recorded symptom scores twice daily in the eDiary. The daily clinical symptoms included: cough, wheezing, shortness of breath, sputum volume, sputum color, and night time awakening. The range of scores for each assessment is 0 to 3 where 0 indications No symptom and 3 indicates a Severe symptom. The maximum daytime total score is 27 and the maximum nighttime total score is 27. The total daily symptom score is obtained by adding the scores for the morning and evening symptoms for each day. The maximum possible total daily score is 54. A negative change from baseline indicated improvement.|BL, 12 Weeks|Full Analysis Set (FAS) The FAS included all randomized participants who received at least one dose of study treatment. Participants, who had both baseline and week 12 values, were included in the analysis.||score on a scale||Standard Error|Least Squares Mean
668393|NCT01727141|Secondary|Change From Baseline in Mean Daily Number of Puffs of Rescue Medication|Participants completed an electronic diary (eDiary) twice daily at the same time in the morning and evening to record the number of puffs of rescue medication taken in the previous 12 hours. A negative change from baseline indicates improvement.|BL, 12 Weeks|Full Analysis Set (FAS) The FAS included all randomized participants who received at least one dose of study treatment. Participants, who had both baseline and week 12 values, were included in the analysis.||Number of puffs||Standard Error|Least Squares Mean
668394|NCT01727141|Secondary|Transitional Dyspnea Index (TDI) Focal Score|The Baseline Dyspnea Index (BDI) / TDI is an instrument used to assess a participant's level of dyspnea. The BDI and TDI each have three domains: functional impairment, magnitude of task and magnitude of effort. BDI domains were rated from 0 (severe) to 4 (unimpaired) and rates summed for baseline focal score ranged from 0 to 12; lower scores mean worse severity. TDI domains were rated from -3 (major deterioration) to 3 (major improvement) and rates summed for transition focal score ranged from -9 to 9; negative scores indicate deterioration. A TDI focal score of ≥1 was defined as a clinically important improvement from baseline.|BL, 12 weeks|Full Analysis Set (FAS) The FAS included all randomized participants who received at least one dose of study treatment. Participants, who had both baseline and week 12 scores, were included in the analysis.||score on a scale||Standard Error|Least Squares Mean
668395|NCT01727141|Secondary|Change From Baseline in Standardized FEV1 AUC (0-4 h), FEV1 AUC (4-8h), FEV1 AUC (8-12h) and FEV1 AUC (0-12 h)|Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction. The trapezoidal rule was used to calculate FEV1 AUC and then normalized to the length of time.|BL, day 1, week 12|Full Analysis Set: The FAS included all randomized participants who received at least one dose of study treatment. Participants, who had both baseline and post baseline values for a given time point, were included in the analysis for that time point.||Liters||Standard Error|Least Squares Mean
668396|NCT01727141|Secondary|Change From Baseline in FVC|Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FVC was defined as the average of the pre-dose FVC measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FVC measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction.|BL, Day 1: 5min, 15min, 1h, 2h, 4h, 6h, 8h, 11h55 min;Day 2: 23h15min, 23h45min;Day 15: -45min, -15min, 1h;Day 29: -45 min, -15min, 1h;Day 57: -45min, -15min, 1h;Day 85: -45min, -15min, 5min, 15min, 1h, 2h, 4h, 6h, 8h, 11h 55min;Day 86: 23h15min; 23h45min|Full Analysis Set (FAS): The FAS included all randomized participants who received at least one dose of study medication. Participants, who has both baseline and post baseline values for a given time point, were included in the analysis for that time point.||Liters||Standard Error|Least Squares Mean
668397|NCT01727141|Secondary|Change From Baseline in FEV1|Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction.|BL, Day 1:5min, 15min, 1h, 2h, 4h, 6h, 8h, 11h55 min;Day 2: 23h15min, 23h45min;Day 15: -45min, -15min, 1h;Day 29: -45 min, -15min, 1h;Day 57: -45min, -15min, 1h;Day 85: -45min, -15min, 5min, 15min, 1h, 2h, 4h, 6h, 8h, 11h55min;Day 86: 23h15min; 23h45min|Full Analysis Set (FAS): The FAS included all randomized participants who received at least one dose of study medication. Participants, who has both baseline and post baseline values for a given time point, were included in the analysis for that time point.||Liters||Standard Error|Least Squares Mean
668398|NCT01727141|Secondary|Change From Baseline in Pre-dose Trough FEV1|Pulmonary function assessments were performed using centralized spirometry according to international standards. Pre-dose trough FEV1 was analyzed using the same MMRM as specified for FEV1. Pre-dose trough FEV1 was defined as the mean of FEV1 at -45 min and -15 min before the morning dose. Since the time of evening dose of the previous day was not recorded at these visits, no time window was applied.|BL, day 85|Full Analysis Set (FAS): The FAS included all randomized participants who received at least one dose of study treatment. Participants, who had both baseline and week 12 values, were included in the analysis.||Liters||Standard Error|Least Squares Mean
668399|NCT01727141|Secondary|Change From Baseline in Trough FEV1|Pulmonary function assessments were performed using centralized spirometry according to international standards. Trough FEV1 was analyzed using the same MMRM as specified for FEV1. Trough FEV1 was defined as the mean of FEV1 at 23 h 15 min and 23 h 45 min after the morning dose of the previous day. Before the mean was calculated, a time window of 10 – 13 hours post-evening dose was applied to these 2 measurements. Recordings outside the time window were set to missing.|BL, day 2, day 86|Full Analysis Set (FAS): The FAS included all randomized participants who received at least one dose of study treatment. Participants, who had both baseline and post baseline values for a given time point, were included in the analysis for that time point.||Liters||Standard Error|Least Squares Mean
668732|NCT01721096|Secondary|Target Vessel Revascularization (Non-TLR)|Target vessel revascularization (TVR) includes ischemia driven TVR, non-TLR and non- ischemia driven TVR, non-TLR.|8 months post index procedure|||percentage of participants|||Number
668400|NCT01727141|Secondary|Percentage of Participants With a Clinically Important Improvement of at Least 4 Units in the SGRQ Total Score|"Participants reported change in health status by using the SGRQ. The SGRQ contains 50 items divided into 2 parts covering 3 aspects of health related to COPD: Part I covers Symptoms and is concerned with respiratory symptoms, their frequency and severity; Part II covers Activity and is concerned with activities that cause or are limited by breathlessness; Part II is also concerned with Impacts, which covers a range of aspects concerned with social functioning and psychological disturbances resulting from airways disease. A score was calculated for each of these 3 subscales and a Total score was calculated. In each case the lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status."|12 weeks|Participants from the full analysis set, who had a SGRQ total score, were included in the analysis. The full analysis set included all randomized participants who received at least one dose of study treatment.||Percentage of participants|||Number
668401|NCT01727141|Secondary|Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score|"Participants reported change in health status by using the SGRQ. The SGRQ contains 50 items divided into 2 parts covering 3 aspects of health related to COPD: Part I covers Symptoms and is concerned with respiratory symptoms, their frequency and severity; Part II covers Activity and is concerned with activities that cause or are limited by breathlessness; Part II is also concerned with Impacts, which covers a range of aspects concerned with social functioning and psychological disturbances resulting from airways disease. A score was calculated for each of these 3 subscales and a Total score was calculated. In each case the lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status. Missing week 12 data were imputed with Last Observation Carried Forward (LOCF) method but only if measured at day >= 29. A negative change from baseline indicates improvement."|BL, 12 Weeks|Full Analysis Set: The full analysis set included all randomized participants who received at least one dose of study treatment. Participants missing week 12 data were not included in the analysis.||score on a scale||Standard Error|Least Squares Mean
668402|NCT01727141|Primary|Change From Baseline in Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) (0-12 Hours (h))|Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction. Missing values of FEV1 AUC0-12 at Day 1 and Week 12 will not imputed. The trapezoidal rule was used to calculate FEV1 AUC and then normalized to the length of time.|baseline (BL), 12 Weeks|Full Analysis Set: The full analysis set included all randomized participants who received at least one dose of study treatment. Participants, who were missing day 1 and/or week 12 FEV1 AUC 0-12h measurements, were not included in the analysis.||Liter||Standard Error|Least Squares Mean
668403|NCT01727024|Secondary|Number of Participnats With Difficulties Experienced When Handling the Devices|Participants used a patient diary to report difficulties with handling the device. Thirteen difficulty categories were assessed.|1 week|The safety analysis set, which included participants who received at least one dose of study medication, was considered for the analysis. However, only participants who had observed values, were analyzed.||Participants|||Number
668404|NCT01727024|Secondary|Number of Participants With Preference for Either Device|Participants answered a single question to determine their device preference.|day 7|The full analysis set, which included the eligible randomized participants, was considered for the analysis. However, only participants with preference responses values were analyzed.||Participants|||Number
668405|NCT01727024|Secondary|Mean Score of the Feeling of Satisfaction With the Inhaler (FSI-10) Questionnaire|"Participants completed the FSI-10 questionnaire to assess their satisfaction with the devices.
The questionnaire contained 10 questions. each one with 5 possible answers in a Likert scale from 5 (a lot) to 1 (almost nothing). The total overall satisfaction score ranged from 0 - 50. Higher values indicated greater satisfaction"|day 7|The full analysis set, which included the eligible randomized participants, was considered for the analysis. However, only participants with observed values were analyzed.||score on a scale||Standard Deviation|Mean
668406|NCT01727024|Secondary|Number of Participants Correctly Using the Device After One Week of Handling|The correct use of 2 drug delivery systems was measured. Participants were given written instructions prior to the first treatment at day one and a check list was used to report the proper handling of the devices.|day 7|The full analysis set, which included the eligible randomized participants, was considered for the analysis. However, only participants with day 7 values were analyzed.||Participants|||Number
668407|NCT01727024|Primary|Number of Participants Who Correctly Used the Device at the Start of Handling the Device|The correct use of 2 drug delivery systems was measured. Participants were given written instructions prior to the first treatment at day one and a check list was used to report the proper handling of the devices.|day 1|The full analysis set, which included the eligible randomized participants, was considered for the analysis. However, only participants with day 1 values were analyzed.||Participants|||Number
668408|NCT01726621|Primary|User Acceptance of the New MiniMed 620G and 640G Insulin Pumps and Guardian Link Transmitter|Descriptive summary will be used to characterize the results of the study questionnaires. The questionnaire will use a Likert scale (rating of 1 to 7) to assess overall subject acceptance of the MiniMed 620G, 640G, and Guardian Link Transmitter. A response of 4 or greater on the Likert scale will be considered positive and indicate and product acceptance.|Four weeks of pump wear|||units on a scale||Standard Deviation|Mean
668409|NCT01726517|Secondary|Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse|"Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment, confirmed with 2 consecutive values (second confirmation value could be posttreatment), or last available on-treatment measurement with no subsequent follow-up values.
Viral relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement."|Baseline to Posttreatment Week 24|||percentage of participants|||Number
668410|NCT01726517|Secondary|Percentage of Participants With SVR at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR24)|SVR2, SVR4, SVR8, and SVR24 was defined as HCV RNA < LLOQ at 2, 4, 8, and 24 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 2, 4, 8, and 24|Full Analysis Set||percentage of participants|||Number
668412|NCT01726517|Primary|Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants were randomized and received at least 1 dose of study drug||percentage of participants|||Number
668413|NCT01726504|Secondary|Percentage of Weekly Frequency of Rescue Medicine and Other Defecation Assistances Used|Rescue medicine for constipation during the trial will be recorded. For rescue medicine, any participants experiencing no bowel movements for 3 or more consecutive days during the whole trial period were allowed to use a 110 ml glycerol anal enema or 40–60 ml sorbitol anal enema as a rescue medicine with documentation in the stool diary.Other If a patient used other medicine, it should be also recorded in the diary.Only the frequences of rescue medicine and other medicine for constipation will be recorded in diary by patient. Weekly frequencies were combined across Weeks 1-8 and 9-20 per participant by averaged across all measurements.|1-20 weeks|||percentage of participants|||Number
668414|NCT01726504|Secondary|The Number of Participants Using Rescue Medicine for Constipation||1-20 weeks|||participants|||Number
668415|NCT01726504|Secondary|Mean of Weekly Frequency of Rescue Medicine and Other Defecation Assistances Used|Rescue medicine for constipation during the trial will be recorded. For rescue medicine, any participants experiencing no bowel movements for 3 or more consecutive days during the whole trial period were allowed to use a 110 ml glycerol anal enema or 40–60 ml sorbitol anal enema as a rescue medicine with documentation in the stool diary.Other If a patient used other medicine, it should be also recorded in the diary.Only the frequences of rescue medicine and other medicine for constipation will be recorded in diary by patient. Weekly frequencies were combined across Weeks 1-8 and 9-20 per participant by averaged across all measurements.|1-20 weeks|||number of times per week||Standard Error|Mean
668416|NCT01726504|Secondary|Number of Participants With Adverse Events Related to Acupuncture||1-8 weeks|||participants|||Number
668417|NCT01726504|Secondary|Then Change Score of Health-related Quality of Life Via Patient-Assessment of Constipation Quality Of Life (PAC-QOL)|Patient-Assessment of Constipation Quality Of Life(PAC-QOL) ranges are 28-140,and higher values represent a worse outcome.Subscales are summed to compute the total score. The changed score of PAC-QOL at week 8, compared with baseline.|baseline and the end of 8th week|||score on a scale||Standard Error|Mean
668418|NCT01726504|Secondary|Change of Average Weekly Degree of Difficulty in Defecation From Baseline|"The degree of straining during self-defecation: The severity of straining is graded using a 4-point ordinal scale.
0 = not at all
= more straining than not
= a great deal
= an extreme amount, need finger manipulation to defecate average weekly degree of difficulty in self-defecation during 1-8weeks,compared with baseline"|Baseline and weeks 1-8|||scores on a scale||Standard Error|Mean
668419|NCT01726504|Secondary|Mean Scores for Stool Consistency and Straining During Weeks 1–8|average weekly stool consistency (Bristol Stool Scale) assessment of self-defecation during the 1-8weeks of treatment,compared with baseline. Bristol Stool Scale including 7-type, scored by 1 to 7 respectively.Type 1: Separate hard lumps, like nuts (hard to pass); Type 2: Sausage-shaped, but lumpy; Type 3: Like a sausage but with cracks on its surface; Type 4: Like a sausage or snake, smooth and soft; Type 5: Soft blobs with clear cut edges (passed easily); Type 6: Fluffy pieces with ragged edges, a mushy stool; Type 7: Watery, no solid pieces. Entirely liquid. Type 3, 4 are normal.|Baseline and weeks 1-8|||score on a scale||Standard Error|Mean
668420|NCT01726504|Secondary|Mean Weekly SBMs During Weeks 1-8|The changed number in mean of weekly average SBMs (spontaneous bowel movement) during 8-week treatment, compared with baseline.|Baseline and weeks 1-8|||number of times||Standard Error|Mean
668421|NCT01726504|Secondary|Changes in Mean Weekly CSBMs During Weeks 9–20|The changed number in mean weekly average CSBMs during 9-20th weeks, compared with baseline.|Baseline and weeks 9-20|||number of times||Standard Error|Mean
668422|NCT01726504|Secondary|the Percentage of Participants With Three or More Weekly CSBMs|the percentage of participants with three or more weekly CSBMs during weeks 1-8 and weeks 9-20|1-20 weeks|||percentage of participants|||Number
668423|NCT01726504|Primary|the Change in Mean Weekly CSBMs During Weeks 1–8 Since Treatment|the change number in mean weekly CSBMs during weeks 1–8 since treatment compared with baseline.|Baseline and weeks 1-8|||number of times||Standard Error|Mean
668424|NCT01726335|Secondary|Global Assessment of Functioning (GAF) Scale Score|The GAF scale is a 100-point tool rating overall psychological, social and occupational functioning of adults. The higher score range (91-100) refers to a superior functioning in a wide range of activities, and absence of symptoms. The lower score range (1-10) refers to persistent danger of severely hurting self or others; or persistent inability to maintain minimum personal hygiene; or serious suicidal act with clear expectation of death.|Screening, and Week 8, 16, 24, 38 and 50|The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.||Units on a scale||Standard Error|Mean
668425|NCT01726335|Secondary|Personal and Social Performance (PSP) Scale Score|The PSP scale assesses the degree of a participant’s dysfunction (ranging from i [absent] to vi [very severe) within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behavior. The overall score ranges from 1 to 100. Based on the 4-domains there was one total score. Participants with a score of 71 to 100 had a mild degree of difficulty; from 31 to 70, varying degrees of disability; participants with scores of 30 or less function so poorly as to require intensive supervision.|Screening, and Week 8, 16, 24, 38 and 50|The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.||Units on a scale||Standard Error|Mean
668426|NCT01726335|Primary|Positive and Negative Syndromes Scale (PANSS) Total Score at Week 50|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Week 50|The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.||Units on a scale||Standard Error|Mean
668489|NCT01725984|Primary|Evaluate the 24-hour Pad Weight at the Final Prospective Follow-up Visit|Percentage of subjects at a given weight for their 24-hour pad weight test at the final prospective follow-up visit.|Prospective follow-up to 36 Months Post Procedure|||percentage of subjects|||Number
668427|NCT01726335|Primary|Positive and Negative Syndromes Scale (PANSS) Total Score at Week 38|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Week 38|The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.||Units on a scale||Standard Error|Mean
668428|NCT01726335|Secondary|Short Form-36 (SF-36) - Quality of Life|The SF-36 is a survey of participant health. It consists of eight scaled scores, which are the weighted sums of the questions in their section. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Each item is scored on a 0-100 range so that the lowest and highest possible scores are set at 0 and 100, respectively. All items are scored so that a high score defines a more favorable health state.|Baseline and Week 50|The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.||Units on a scale||Standard Deviation|Mean
668429|NCT01726335|Secondary|Drug Attitude Inventory (DAI-10)|The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. It is the binary scale assessing the participant's subjective response. A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive subjective response (SR); a negative sum of scores indicates a negative SR (non-compliant). The final score is the grand total of the positive and negative points. Total score ranges from (-) 10 to (+) 10, higher score indicates positive SR (compliant) and lower score indicates negative SR (non-compliant).|Screening, and Week 8, 24 and 50|ITTs population included all the Participants who received at least one dose of study medication and were reassessed after the start of use. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.||Units on a scale||Standard Error|Mean
668430|NCT01726335|Secondary|Extrapyramidal Symptoms Rating Scale (ESRS) Total Score|The ESRS is used to assess four types of drug-induced movement disorders administered as a questionnaire. Score range from 0 to 6 (0 is absent and 6 is extremely severe).|Baseline and Week 2, 4, 8, 16, 24 and 50|Intent-to-treat-safety evaluation (ITTs) population included all the Participants who received at least one dose of study medication and were reassessed after the start of use. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.||Units on a scale||Standard Error|Mean
668431|NCT01726335|Secondary|Clinical Global Impressions (CGI) - Disease Severity Score|"The CGI rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 indicates to normal, not at all ill and a rating of 7 indicates among the most extremely ill participants. Higher scores indicate worsening."|Baseline and Week 2, 4, 8, 16, 24, 38 and 50|The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.||Units on a scale||Standard Error|Mean
668432|NCT01726335|Primary|Positive and Negative Syndromes Scale (PANSS) Total Score at Week 24|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Week 24|The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.||Units on a scale||Standard Error|Mean
668433|NCT01726335|Primary|Positive and Negative Syndromes Scale (PANSS) Total Score at Week 16|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Week 16|The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.||Units on a scale||Standard Error|Mean
668434|NCT01726335|Primary|Positive and Negative Syndromes Scale (PANSS) Total Score at Week 8|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Week 8|The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.||Units on a scale||Standard Error|Mean
668435|NCT01726335|Primary|Positive and Negative Syndromes Scale (PANSS) Total Score at Week 4|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Week 4|The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.||Units on a scale||Standard Error|Mean
668436|NCT01726335|Primary|Positive and Negative Syndromes Scale (PANSS) Total Score at Week 2|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Week 2|Intent-to-treat-efficacy evaluation (ITTe) population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.||Units on a scale||Standard Error|Mean
668437|NCT01726049|Other Pre-specified|Echocardiographic Parameters of Diastolic LV Dysfunction||12 weeks||||||
671890|NCT01680549|Primary|Patient Pain Scores|"Patient's pain assessed by the Visual Analog Scale (VAS - Units on a scale) on postoperative days 0, 1 and 2.
Scale range: 0-100 Higher Values = More Pain"|3 days|||units on a scale- VAS||Standard Deviation|Mean
668438|NCT01726049|Secondary|Wedge Pressure Measured Invasively by Right Heart Catheterization|Difference in change of wedge pressure between baseline and 12 weeks between Sildenafil group and Placebo group|baseline and 12 weeks|52 patients randomized. 26 Sildenafil arm: 26 placebo arm: change in wedge pressure could be evaluated in the ITT analyses in 21 and 22 subjects of the Sildenafil and placebo treatment group||mmHg||95% Confidence Interval|Mean
668439|NCT01726049|Secondary|Cardiac Output Measured Invasively by Right Heart Catheterization|difference in change of cardiac output between baseline and 12 weeks between Sildenafil and Placebo group|baseline and 12 weeks|52 patients randomized. 26 Sildenafil arm: 26 placebo arm: change in cardiac output could be evaluated in the ITT analyses in 20 and 22 subjects of the Sildenafil and placebo treatment group||mililiter/min||95% Confidence Interval|Mean
668440|NCT01726049|Secondary|VO2max|difference in change of VO2 max between baseline and 12 weeks between Sildenafil and placebo group|baseline and 12 weeks|52 patients randomized. 26 Sildenafil arm: 26 placebo arm: change in VO2max could be evaluated in the ITT analyses in 18 and 22 subjects of the Sildenafil and placebo treatment group||ml/kg/min||95% Confidence Interval|Mean
668441|NCT01726049|Primary|Mean Pulmonary Artery Pressure Measured by Right Heart Catheterization|change of mean pulmonary artery pressure between baseline and 12 weeks measured by heart catheterisation|baseline and 12 weeks|52 patients randomized. 26 Sildenafil arm: 26 placebo arm: change in mean pulmonary artery pressure could be evaluated in the intention to treat (ITT) analyses in 21 and 22 subjects of the Sildenafil and placebo treatment group||mmHG||95% Confidence Interval|Mean
668442|NCT01726023|Secondary|Plasma Concentrations for Ceftazidime and Avibactam|Blood samples were taken from all patients on Day 3 for the pharmacokinetic evaluation of ceftazidime and avibactam plasma concentrations|At Day 3: Anytime within 15 minutes prior to or after stopping study drug, anytime between 30 and 90 minutes after stopping study drug, anytime between 300 minutes and 360 minutes after stopping study drug.|PK analysis set||ng/mL||Full Range|Geometric Mean
668443|NCT01726023|Secondary|Safety and Tolerability:ECG , QTcB and QTcF Intervals|Shifts in ECG interpretation and changes in QT, QTcB, and QTcF intervals , from baseline to post baseline.|EOT visit/any observation on treatment|Safety analysis set: all patients who received at least 1 dose of IP||Number of patients|||Number
668444|NCT01726023|Secondary|Safety and Tolerability: Clinical Laboratory Evaluation Clinical Chemistry.|Potentially clinically significant (PCS) post Baseline clinical chemistry values up to LFU (Safety analysis set)|study duration (from screening to Day 49 LFU visit)|Safety analysis set: all patients who received at least 1 dose of IP||Number of patients|||Number
668445|NCT01726023|Secondary|Safety and Tolerability: Clinical Laboratory Evaluation Hematology.|Potentially clinically significant (PCS) post Baseline hematology values up to LFU (Safety analysis set)|study duration (from screening to Day 49 LFU visit)|Safety analysis set: all patients who received at least 1 dose of IP||Number of patients|||Number
668446|NCT01726023|Secondary|Safety and Tolerability by Incidence: Extent of Exposure.|Duration of exposure is calculated as the difference between the last study therapy date and the first study therapy date converted to days plus 1 day. Actual calculated duration could be shorter or longer than a full day.|study duration (from screening to Day 49 LFU visit)|Safety analysis set: all patients who received at least 1 dose of IP||Number of patients|||Number
668447|NCT01726023|Secondary|Safety and Tolerability by Incidence and Severity of Adverse Events and Serious Adverse Events and Mortality.|Adverse event data were collected from the screening/consent visit until the late follow-up visit (i.e. Day -1/0 to Day 42).|study duration (from screening to Day 49 LFU visit)|Safety analysis set: all patients who received at least 1 dose of IP||Number of patients|||Number
668448|NCT01726023|Secondary|The Time to First Defervescence in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set for Patients Who Have Fever at Study Entry.|Time to first defervescence was calculated for patients with a fever (>38ºC) at baseline. Defervescence (≤37.8ºC) was defined as the absence of fever based on the highest temperature recorded on each study day. Time to first defervescence while on IV study therapy in the CE analysis set at TOC for patients who had fever at study entry is defined as time (in days) from the first dose of IV study therapy to first absence of fever.|while on study therapy (from Day 1 to Day 14)|microbiological modified intent-to-treat (mMITT) with fever, defined as >38ºC at study entry. No participants were censored at the time of last observation.||Days||Full Range|Median
668449|NCT01726023|Secondary|The Time to First Defervescence in the Clinically Evaluable (CE) Analysis Set for Patients Who Have Fever at Study Entry.|Time to first defervescence was calculated for patients with a fever (>38ºC) at baseline. Defervescence (≤37.8ºC) was defined as the absence of fever based on the highest temperature recorded on each study day. Time to first defervescence while on IV study therapy in the CE analysis set at TOC for patients who had fever at study entry is defined as time (in days) from the first dose of IV study therapy to first absence of fever.|while on study therapy (from Day 1 to Day 14)|Clinically evaluable (CE) with fever, defined as >38ºC at study entry. No participants were censored at the time of last observation.||Days||Full Range|Median
668450|NCT01726023|Secondary|The Proportion of Patients With a Favorable Per Patient Microbiological Response at the Test of Cure (TOC) Visit for Patients Infected With Ceftazidime Resistant Pathogens in the Extended Microbiologically Evaluable (ME) Analysis Set.|The microbiological responses as per the protocoled criteria: responses other than “indeterminate” were classified as “favorable” or “unfavorable.” Favorable microbiological response assessments included “eradication” and “presumed eradication.” Unfavorable microbiological response assessments included “persistence,” “persistence with increasing minimum inhibitory concentration (MIC),” and “presumed persistence.” Indeterminate microbiologic response assessments included cases where the clinical response was changed to indeterminate due to an SRP assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).|At the test of cure (TOC) (Day 28 to 35)|Extended microbiologically evaluable(ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture regardless of susceptibility.||Number of patients|||Number
668490|NCT01725984|Primary|Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use|"Evaluate the proportion of subjects using the following categories of pads per day at the three month and final prospective follow-up visit:
0 pads per day or 1 dry prophylactic pad; 1 pad per day; 2 pads per day; 3 pads per day; 4 pads per day; 5 or more pads per day (5, 6, 7, 8 etc. pads per day);"|Baseline|||percentage of subjects|||Number
668451|NCT01726023|Secondary|The Proportion of Patients With a Favorable Per Patient Microbiological Response at the Test of Cure (TOC) Visit for Patients Infected With Ceftazidime Resistant Pathogens in the Microbiologically Evaluable (ME) Analysis Set.|The microbiological responses as per the protocoled criteria: responses other than “indeterminate” were classified as “favorable” or “unfavorable.” Favorable microbiological response assessments included “eradication” and “presumed eradication.” Unfavorable microbiological response assessments included “persistence,” “persistence with increasing minimum inhibitory concentration (MIC),” and “presumed persistence.” Indeterminate microbiologic response assessments included cases where the clinical response was changed to indeterminate due to an SRP assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).|At the test of cure (TOC) (Day 28 to 35)|Microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible to both treatment groups.||Number of patients|||Number
668452|NCT01726023|Secondary|The Proportion of Patients With a Favorable Per Patient Microbiological Response at the Test of Cure (TOC) Visit for Patients Infected With Ceftazidime Resistant Pathogens in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.|The microbiological responses as per the protocoled criteria: responses other than “indeterminate” were classified as “favorable” or “unfavorable.” Favorable microbiological response assessments included “eradication” and “presumed eradication.” Unfavorable microbiological response assessments included “persistence,” “persistence with increasing minimum inhibitory concentration (MIC),” and “presumed persistence.” Indeterminate microbiologic response assessments included cases where the clinical response was changed to indeterminate due to an SRP assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).|At the test of cure (TOC) (Day 28 to 35)|The microbiological modified intent-to-treat (mMITT) analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.||Number of patients|||Number
668453|NCT01726023|Secondary|The Proportion of Favorable Per-pathogen Microbiological Response at the Late Follow up (LFU) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.|The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.|At the late follow up (LFU) (Day 42 to 49)|Extended microbiologically evaluable(ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture regardless of susceptibility.||Participants with favorable responses|||Number
668454|NCT01726023|Secondary|The Proportion of Favorable Per-pathogen Microbiological Response at the Test of Cure (TOC) Visit in the Extended Microbiologically Evaluable(ME) Analysis Set.|The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.|At the test of cure (TOC) (Day 28 to 35)|Extended microbiologically evaluable(ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture regardless of susceptibility.||Participants with favorable responses|||Number
668455|NCT01726023|Secondary|The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.|The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.|At the end of treatment (EOT) (within 24 hours after last IV dose)|Extended microbiologically evaluable(ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture regardless of susceptibility.||Participants with favorable responses|||Number
668456|NCT01726023|Secondary|The Proportion of Favorable Per-pathogen Microbiological Response at the Late Follow up (LFU) Visit in the Microbiologically Evaluable (ME) Analysis Set.|The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.|At the late follow up (LFU) (Day 42 to 49)|Microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible to both treatment groups.||Participants with favorable responses|||Number
668457|NCT01726023|Secondary|The Proportion of Favorable Per-pathogen Microbiological Response at the Test of Cure (TOC) Visit in the Microbiologically Evaluable (ME) Analysis Set.|The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.|At the test of cure (TOC) (Day 28 to 35)|Microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible to both treatment groups.||Participants with favorable responses|||Number
668491|NCT01725984|Primary|Percentage of Subjects Cured, Improved, or Failed Based on Reported Pad Per Day Use|Evaluate the proportion of subjects cured (0 pads per day or 1 dry prophylactic pad), improved (not cured and ≥50% reduction in pad use), or failed (not cured and not improved) at the three month and final prospective follow-up visit|3 months Post Procedure|||percentage of subjects|||Number
668492|NCT01725984|Primary|Percentage of Subjects With a ≥50% Reduction in Pads Per Day Use|Evaluate the proportion of subjects with a ≥50% reduction in pads per day use|3 Months Post Procedure|||percentage of participants|||Number
668458|NCT01726023|Secondary|The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Microbiologically Evaluable (ME) Analysis Set.|The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.|At the end of treatment (EOT) (within 24 hours after last IV dose)|Microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible to both treatment groups.||Participants with favorable responses|||Number
668459|NCT01726023|Secondary|The Proportion of Favorable Per-pathogen Microbiological Response in the Microbiological Response at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.|The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.|At the late follow up (LFU) (Day 42 to 49)|The mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.||Participants with favorable responses|||Number
668460|NCT01726023|Secondary|The Proportion of Favorable Per-pathogen Microbiological Response in the Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.|The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.|At the test of cure (TOC) (Day 28 to 35)|The mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.||Participants with favorable responses|||Number
668461|NCT01726023|Secondary|The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.|The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.|At the end of treatment (EOT) (within 24 hours after last IV dose)|The mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.||Participants with favorable responses|||Number
668462|NCT01726023|Secondary|The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated."|At the late follow up (LFU) (Day 42 to 49)|The microbiological modified intent-to-treat (mMITT) analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.||Number of patients|||Number
668463|NCT01726023|Secondary|The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated."|At the test of cure (TOC) (Day 28 to 35)|The microbiological modified intent-to-treat (mMITT) analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.||Number of patients|||Number
668464|NCT01726023|Secondary|The Proportion of Patients With a Favorable Per-patient Microbiological Response at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated."|At the end of treatment (EOT) (within 24 hours after last IV dose)|The microbiological modified intent-to-treat (mMITT) analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.||Number of patients|||Number
668465|NCT01726023|Secondary|The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Late Follow up (LFU) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated."|At the late follow up (LFU) (Day 42 to 49)|Extended microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture regardless of susceptibility.||Number of patients|||Number
668466|NCT01726023|Secondary|The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Test of Cure (TOC) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated."|At the test of cure (TOC) (Day 28 to 35)|Extended microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture regardless of susceptibility.||Number of patients|||Number
668722|NCT01721096|Secondary|Percent Diameter Stenosis (%DS)|The value calculated as 100 * (1 - minimum lumen diameter/reference vessel diameter) (MLD/RVD) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).|Baseline|||percentage of DS|Participants|Standard Deviation|Mean
668467|NCT01726023|Secondary|The Proportion of Patients With a Favorable Per-patient Microbiological Response at the End of Treatment (EOT) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated."|At the end of treatment (EOT) (within 24 hours after last IV dose)|Extended microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture regardless of susceptibility.||Number of patients|||Number
668468|NCT01726023|Secondary|The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Late Follow up (LFU) Visit in the Microbiologically Evaluable (ME) Analysis Set.|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated."|At the late follow up (LFU) (Day 42 to 49)|Microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible to both treatment groups.||Number of patients|||Number
668469|NCT01726023|Secondary|The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Test of Cure (TOC) Visit in the Microbiologically Evaluable (ME) Analysis Set.|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated."|At the test of cure (TOC) (Day 28 to 35)|Microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible to both treatment groups.||Number of patients|||Number
668470|NCT01726023|Secondary|The Proportion of Patients With a Favorable Per-patient Microbiological Response at the End of Treatment (EOT) Visit in the Microbiologically Evaluable (ME) Analysis Set.|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated."|At the end of treatment (EOT) (within 24 hours after last IV dose)|Microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible to both treatment groups.||Number of patients|||Number
668471|NCT01726023|Secondary|The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Clinically Evaluable (CE) Analysis Set.|The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.|At late follow up (LFU) visits (Day 42 to 49)|The clinically evaluable (CE) analysis set included all patients who met the disease definition of cIAI and met the stringent criteria for clinical evaluation described in the protocol regarding dosing, concomitant medication, evaluation, etc.||Number of patients|||Number
668472|NCT01726023|Secondary|The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Clinically Evaluable (CE) Analysis Set.|The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.|At the end of treatment (EOT) (within 24 hours after last IV dose)|The clinically evaluable (CE) analysis set included all patients who met the disease definition of cIAI and met the stringent criteria for clinical evaluation described in the protocol regarding dosing, concomitant medication, evaluation, etc.||Number of patients|||Number
668473|NCT01726023|Secondary|The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.|The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.|At the late follow up (LFU) (Day 42 to 49)|The microbiological modified intent-to-treat mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.||Number of patients|||Number
668474|NCT01726023|Secondary|The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.|The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.|At the test of cure (TOC) (Day 28 to 35)|The microbiological modified intent-to-treat mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.||Number of patients|||Number
668475|NCT01726023|Secondary|The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.|The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.|At the end of treatment (EOT) (within 24 hours after last IV dose)|The microbiological modified intent-to-treat mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.||Number of patients|||Number
668476|NCT01726023|Secondary|The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.|The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.|At the late follow up (LFU) (Day 42 to 49)|Extended microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture regardless of susceptibility.||Number of patients|||Number
668723|NCT01721096|Secondary|Bleeding||1 year post index procedure|||percentage of participants|||Number
668724|NCT01721096|Secondary|Bleeding||8 months post index procedure|||percentage of participants|||Number
668477|NCT01726023|Secondary|The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.|The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.|At the test of cure (TOC) (Day 28 to 35)|Extended microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture regardless of susceptibility.||Number of patients|||Number
668478|NCT01726023|Secondary|The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.|The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.|At the end of treatment (EOT) (within 24 hours after last IV dose)|Extended microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture regardless of susceptibility.||Number of patients|||Number
668479|NCT01726023|Secondary|The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Microbiologically Evaluable (ME) Analysis Set.|The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.|At the late follow up (LFU) (Day 42 to 49)|Microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible to both treatment groups.||Number of patients|||Number
668480|NCT01726023|Secondary|The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Microbiologically Evaluable (ME) Analysis Set.|The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.|At the test of cure (TOC) (Day 28 to 35)|Microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible to both treatment groups.||Number of patients|||Number
668481|NCT01726023|Secondary|The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Microbiologically Evaluable (ME) Analysis Set.|The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.|At the end of treatment (EOT) (within 24 hours after last IV dose)|Microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible to both treatment groups.||Number of patients|||Number
668482|NCT01726023|Primary|The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Clinically Evaluable (CE) Analysis Set.|The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.|At the test of cure visit (Day 28 to35)|The clinically evaluable (CE) analysis set included all patients who met the disease definition of cIAI and met the stringent criteria for clinical evaluation described in the protocol regarding dosing, concomitant medication, evaluation, etc.||Number of patients|||Number
668483|NCT01725984|Primary|Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use|"Evaluate the proportion of subjects using the following categories of pads per day at the three month and final prospective follow-up visit:
0 pads per day or 1 dry prophylactic pad; 1 pad per day; 2 pads per day; 3 pads per day; 4 pads per day; 5 or more pads per day (5, 6, 7, 8 etc. pads per day);"|Prospective follow-up to 36 Months Post Procedure|||percentage of subjects|||Number
668484|NCT01725984|Primary|Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use|"Evaluate the proportion of subjects using the following categories of pads per day at the three month and final prospective follow-up visit:
0 pads per day or 1 dry prophylactic pad; 1 pad per day; 2 pads per day; 3 pads per day; 4 pads per day; 5 or more pads per day (5, 6, 7, 8 etc. pads per day);"|3 Months Post Procedure|||percentage of subjects|||Number
668485|NCT01725984|Primary|Percentage of Subjects Cured, Improved, or Failed Based on Reported Pad Per Day Use|Evaluate the proportion of subjects cured (0 pads per day or 1 dry prophylactic pad), improved (not cured and ≥50% reduction in pad use), or failed (not cured and not improved) at the three month and final prospective follow-up visit|Prospective follow-up to 36 Months Post Procedure|||percentage of subjects|||Number
668486|NCT01725984|Primary|Percentage of Subjects With a ≥50% Reduction in Pads Per Day Use|Evaluate the proportion of subjects with a ≥50% reduction in pads per day use|Prospective follow-up to 36 Months Post Procedure|||percentage of subjects|||Number
668487|NCT01725984|Primary|Number of Adverse Events Reported Between Arms|Evaluate the occurrence of all AdVance /AdVance XP AEs, as well as those reported as serious, intra-operative, device or procedure related adverse events|Prospective follow-up to 36 Months Post Procedure|||Adverse Events|||Number
668488|NCT01725984|Primary|Change in Quality of Life Scores as Compared to Baseline for I-QOL, ICIQ-SF, and Summary of Values for the PGI-I. Measured From Baseline to Prospective Follow.|"The Incontinence Quality of Life Questionnaire (I-QOL) is a 22 questionnaire that evaluates a subject's quality of life with respect to urinary problems/incontinence. A lower score correlates with more severe incontinence, and an increase from baseline indicates an improvement in quality of life. The score scale is 0 - 100.
The International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) is a 4 question tool that quantifies the impact on quality of life from incontinence. A decrease from baseline to follow-up indicates an improvement in quality of life. The score scale is 1-21.
The Patient Global Impression of Improvement (PGI-I) questionnaire is a single question instrument that assess a subject's perception of the disease impact on their quality of life. Completed at the last visit, a lower score indicates a better perception from the patient. Scale from 1 to 7."|Baseline to Prospective Follow Up (up to 36 months)|||Score on a scale||Standard Deviation|Mean
668725|NCT01721096|Secondary|All Revascularization|All revascularization includes ischemia driven and non-ischemia driven revascularization.|1 year post index procedure|||percentage of participants|||Number
668493|NCT01725529|Secondary|Percentage of Participants With On-treatment Normalization of Alanine Aminotransferase Level|Percentage of participants with on-treatment normalization of alanine aminotransferase level were assessed.|72 weeks after the EOT (Week 24 or 48)|ITT population included all the randomized participants who took at least 1 dose of study drug. ‘N’ (number of participants analyzed) signifies those participants who were analyzed for this measure.||percentage of participants|||Number
668494|NCT01725529|Secondary|Percentage of Participants With Viral Relapse|Viral relapse was defined as undetectable HCV RNA at the actual end of treatment and last HCV RNA measurement during follow-up ≥25 IU/mL.|72 weeks after the EOT (Week 24 or 48)|ITT population included all the randomized participants who took at least 1 dose of study drug. ‘N’ (number of participants analyzed) signifies those participants who were analyzed for this measure.||percentage of participants|||Number
668495|NCT01725529|Secondary|Percentage of Participants With Viral Breakthrough|The number of patients who experience viral breakthrough will be determined by measuring Hepatitis C virus (HCV) ribonucleic acid (RNA) levels in plasma. Viral breakthrough was defined as a confirmed increase of >1 log10 IU/mL in HCV RNA level from the lowest level reached, or a confirmed HCV RNA level of >100 IU/mL in subjects whose HCV RNA levels had previously been below the limit of quantification (<25 IU/mL detectable) or undetectable (<25 IU/mL undetectable) while on study treatment.|Week 24 or 48 (End of Treatment)|ITT population included all the randomized participants who took at least 1 dose of study drug. ‘N’ (number of participants analyzed) signifies those participants who were analyzed for this measure.||percentage of participants|||Number
668496|NCT01725529|Secondary|Percentage of Participants With On-treatment Failure|A participant with on-treatment failure refers to a participant with confirmed detectable HCV RNA at the end of treatment.|End of Treatment (EOT: Week 24 or 48)|ITT population included all the randomized participants who took at least 1 dose of study drug.||percentage of participants|||Number
668497|NCT01725529|Secondary|Percentage of Participants With Sustained Virologic Response at Week 72 (SVRW72)||Week 72|ITT population included all the randomized participants who took at least 1 dose of study drug. ‘N’ (number of participants analyzed) signifies those participants who were analyzed for this measure.||percentage of participants|||Number
668498|NCT01725529|Secondary|Percentage of Participants With Sustained Virologic Response 24 Weeks After End of Study Drug Treatment (SVR24)|Participants considered to have achieved SVR24 if both conditions are met: 1). the hepatitis C virus ribonucleic acid (HCV RNA) is less than (<) lower limit of quantification (LLOQ;25 IU/mL) undetectable at end of treatment and, 2). the HCV RNA is < LLOQ detectable or undetectable at 24 weeks after the planned end of study drug treatment.|24 weeks after the end of treatment (EOT: Week 24 or 48)|ITT population included all the randomized participants who took at least 1 dose of study drug.||percentage of participants|||Number
668499|NCT01725529|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After End of Study Drug Treatment (SVR12)|Participants considered to have achieved SVR12 if both conditions are met: 1). the hepatitis C virus ribonucleic acid (HCV RNA) is less than (<) lower limit of quantification (LLOQ; 25 international unit per milliliter [IU/mL]) undetectable at end of treatment and, 2). the HCV RNA is < LLOQ detectable or undetectable at 12 weeks after the planned end of study drug treatment.|12 weeks after the end of treatment (EOT: Week 24 or 48)|Intent-to-treat (ITT) population included all the randomized participants who took at least 1 dose of study drug.||Percentage of participants|||Number
668500|NCT01725451|Primary|Pharmacokinetics: Maximum Drug Concentration (Cmax) of Testosterone|The Cmax from time 0 to 72 hours postdose, based on baseline-corrected concentrations. Baseline-corrected Cmax was calculated using the measured concentrations of total testosterone minus mean baseline testosterone concentration. Baseline testosterone concentration was the arithmetic mean of 3 predose concentrations.|Pre-dose [60 to 45 minutes (min), 30 to 15 min, 5 minutes prior to each dose], 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, and 72 hours after administration of study drug|All randomized participants who received at least 1 dose of testosterone 2% solution for the specified treatment regimen.||nanograms per deciliter (ng/dL)||Geometric Coefficient of Variation|Geometric Mean
668501|NCT01725451|Primary|Pharmacokinetics: Area Under the Concentration Curve (AUC) of Testosterone|The AUC from time 0 to 72 hours [AUC (0-72)] postdose, based on baseline-corrected concentrations. Baseline-corrected AUC (0-72) was calculated using the measured concentrations of total testosterone minus mean baseline testosterone concentration. Baseline testosterone concentration was the arithmetic mean of 3 predose concentrations.|Pre-dose [60 to 45 minutes (min), 30 to 15 min, 5 minutes prior to each dose], 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, and 72 hours after administration of study drug|All randomized participants who received at least 1 dose of testosterone 2% solution and had evaluable 72-hour testosterone concentrations.||nanograms* hours per deciliter (ng*h/dL)||Geometric Coefficient of Variation|Geometric Mean
668502|NCT01725386|Secondary|Percentage of Participants With Adverse Events||Up to approximately 4 years|Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).||percentage of participants|||Number
668503|NCT01725386|Secondary|Mean Survival Time||Up to approximately 4 years|Participants eligible for analysis (received at least one dose of study medication and for whom data for at least one follow-up variable were available).||Months||95% Confidence Interval|Mean
668504|NCT01725386|Secondary|Percentage of Participants by Histopathology Grade Diagnosis Assessed at Baseline|To document the metastatic breast cancer participant profile, the percentage of participants with histopathology grade diagnosis of moderately differentiated, well differentiated, poorly differentiated/undifferentiated as assessed at baseline was summarized.|Day 1|Participants eligible for analysis (received at least one dose of study medication and for whom data for at least one follow-up variable were available).||percentage of participants|||Number
668505|NCT01725386|Secondary|Percentage of Participants With Relevant Medical History Assessed at Baseline|To document the metastatic breast cancer participant profile, the percentage of participants with relevant medical history as assessed at baseline was summarized.|Day 1|Participants eligible for analysis (received at least one dose of study medication and for whom data for at least one follow-up variable were available).||percentage of participants|||Number
668506|NCT01725386|Primary|Percentage of Participants Receiving Concomitant Medications During the Study|Percentage of participants receiving concomitant medications during the study along with their prescribed monotherapy or combination therapy were reported.|Up to approximately 4 years|Participants eligible for analysis (received at least one dose of study medication and for whom data for at least one follow-up variable were available).||percentage of participants|||Number
668507|NCT01725386|Primary|Percent of Participants With Capecitabine as a First Line, Second Line, or Third Line Therapy|To document use of Capecitabine regimen in the management of participants with metastatic breast cancer, the choice of Capecitabine monotherapy versus combination therapy was summarized according to whether the selection was for the participant's first, second, or third line of treatment.|Up to approximately 4 years|Participants eligible for analysis (received at least one dose of study medication and for whom data for at least one follow-up variable were available).||percentage of participants|||Number
668508|NCT01725308|Secondary|Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors|The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide).|Weeks 4, 8|SAF; LOCF imputation method was used for all time points. N is the number of participants with available data. Only participants who had a response were included in the analysis.||participants|||Number
668509|NCT01725308|Secondary|Number of Participants With an Affirmative Response to Columbia Suicide Severity Rating Scale (C-SSRS): Suicidal Ideation|The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 5 items for suicide ideation (1. Wish to be dead; 2. Suicidal thoughts; 3. Suicidal thoughts with a method (no specific plan or intent to act); 4. Suicidal intent (without a specific plan); 5. Suicidal intent with specific plan. If participants responded with a negative response for questions 1 and 2, the remaining questions are skipped. If question 2 was responded to with a positive response, the remaining questions need to be asked.|Weeks 4, 8|SAF; LOCF imputation method was used for all time points. N is the number of participants with available data. Only participants who had a response were included in the analysis.||participants|||Number
668510|NCT01725308|Secondary|Change From Baseline in Young Mania Rating Scale (YMRS)|"The YMRS is a scale used to evaluate manic symptoms. The YMRS total score was the total assessment of assessed points for 11 items, ranges from 0 to 60 (each item is scored from either 0-4 or 0-8 by severity (0 = absent and 4/8 = displays mood/behavior to a greater degree). A lower score indicates “Absent” or “Normal."|Baseline and Weeks 1, 2, 3 4, 6, 8|SAF; LOCF imputation method for end of Treatment period I was used. N is the number of participants with available data at the time point.||units on a scale||Standard Deviation|Mean
668511|NCT01725308|Secondary|Change From Baseline in DIEPSS: Parkinsonism|"The DIEPSS is a scale used to evaluate drug-induced extrapyramidal symptoms. DIEPSS is composed of 8 individual symptom parameters and a global assessment of severity, each rated on a 5-point scale, with lower scores indicating as normal. Parkinsonism is a total of the gait disturbance, bradykinesia, salivation, muscle rigidity, and tremor scores and ranges from 0 (none, normal) to 20 (severe)."|Baseline and Weeks 4, 8|SAF; LOCF imputation method for end of Treatment period I was used. N is the number of participants with available data at the time point.||units on a scale||Standard Deviation|Mean
668512|NCT01725308|Secondary|Change From Baseline in Drug Induced Extra-Pyramidal Symptoms Scale (DIEPSS): Total Score|"The DIEPSS is a scale used to evaluate drug-induced extrapyramidal symptoms. DIEPSS is composed of 8 individual symptom parameters and a global assessment of severity, each rated on a 5-point scale, with lower scores indicating as normal. The DIEPSS total score ranges from 0 (none, normal) to 32 (severe), and excludes the global assessment of severity."|Baseline and Weeks 4, 8|SAF; LOCF imputation method for end of Treatment period I was used. N is the number of participants with available data at the time point.||units on a scale||Standard Deviation|Mean
668513|NCT01725308|Secondary|Number of Participants With Adverse Events|An adverse event (AE) is defined as any undesirable or unintended sign (including abnormal laboratory test values), symptom, or disease occurring while the study drug was administered, regardless of whether or not there was a causal relationship with the study drug. A serious AE is defined as a an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important.|up to 8 weeks|Safety Analysis Set (SAF), which included participants who received at least one dose of study drug.||participants|||Number
668514|NCT01725308|Secondary|CGI-BP-C: Overall Bipolar Illness|The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score.|Weeks 1, 2, 3, 4, 6, 8|FAS; LOCF imputation method was used for all time points.||units on a scale||Standard Deviation|Mean
668515|NCT01725308|Secondary|CGI-BP-C: Depression|The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score.|Weeks 1, 2, 3, 4, 6, 8|FAS; LOCF imputation method was used for all time points.||units on a scale||Standard Deviation|Mean
668516|NCT01725308|Secondary|Clinical Global Impression-Bipolar Disorder-Change (CGI-BP-C): Mania|The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score.|Weeks 1, 2, 3, 4, 6, 8|FAS; LOCF imputation method was used for all time points.||units on a scale||Standard Deviation|Mean
668517|NCT01725308|Secondary|Change From Baseline in CGI-BP-S: Overall Bipolar Illness|The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from with the scale from 1 (not ill) to 7 (very severely ill).|Baseline and Weeks 1, 2, 3, 4, 6, 8|FAS; LOCF imputation method was used for all time points.||units on a scale||Standard Deviation|Mean
668518|NCT01725308|Secondary|Change From Baseline in CGI-BP-S: Depression|The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from with the scale from 1 (not ill) to 7 (very severely ill).|Baseline and Weeks 1, 2, 3, 4, 6, 8|FAS; LOCF imputation method was used for all time points.||units on a scale||Standard Deviation|Mean
668519|NCT01725308|Secondary|Change From Baseline in Clinical Global Impression-Bipolar Disorder-Severity (CGI-BP-S): Mania|The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from 1 (not ill) to 7 (very severely ill).|Baseline and Weeks 1, 2, 3, 4, 6, 8|FAS; LOCF imputation method was used for all time points.||units on a scale||Standard Deviation|Mean
668520|NCT01725308|Secondary|Change From Baseline in Hamilton Depression Rating Scale (HAM-D17) Total Score|The HAM-D17 is a clinician-rated 17-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 52, where a higher score indicates a greater depressive state.|Baseline and Weeks 1, 2, 3, 4, 6, 8|FAS; LOCF imputation method was used for all time points.||units on a scale||Standard Deviation|Mean
668521|NCT01725308|Secondary|Change From Baseline in MADRS Total Score|The MADRS is a10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms.|Baseline and Weeks 1, 2, 3, 4, 6, 8|FAS; LOCF imputation was used.||units on a scale||Standard Deviation|Mean
668522|NCT01725308|Primary|Change From Baseline to End of Treatment Period I in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|The MADRS is a10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms.|Baseline and Week 8|FAS. Last observation carried forward (LOCF) imputation for end of Treatment Period I was used.||units on a scale||Standard Deviation|Mean
668523|NCT01725282|Secondary|Safety Assessed by the Incidence of Adverse Events (AE), Vital Signs, Electrocardiogram (ECG) and Laboratory Tests|An AE is defined as any untoward medical occurrence in a patient administered a study drug, and which does not necessarily have a causal relationship with this treatment. Abnormal laboratory parameters, vital signs or ECG data were defined as AEs if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. A serious AE was an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important. AEs were assessed by the Investigator for intensity as mild, moderate or severe and for causal relationship to study drug.|Up to 8 weeks|||participants|||Number
668524|NCT01725282|Secondary|Change From Baseline in Pittsburgh Sleep Quality Index (PSQI)|The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate seven “component” scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction, each on a scale from 0 (best) to 3 (worst). The sum of scores for these seven components yields one global score, ranging from 0 to 21, with higher scores indicative of poor sleep quality.|Baseline and Week 6|Full analysis set with available PSQI data; LOCF was used.||units on a scale||Standard Deviation|Mean
668525|NCT01725282|Secondary|Change From Baseline in Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36)|"The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The 8 health concepts are:
Limitation in physical activities because of health problems.
Limitations in usual role activities because of physical health problems.
Bodily pain.
Limitations in social activities because of physical or emotional problems.
General mental health (psychological distress and well-being).
Limitations in usual role activities because of emotional problems.
Vitality (energy and fatigue).
General health perception.
Each scale ranges from 0 to 100, with 0 indicating the least favorable status and 100 being the most favorable health status."|Baseline and Week 6|Full analysis set with available SF-36 data; LOCF was used.||units on a scale||Standard Deviation|Mean
668526|NCT01725282|Secondary|Percentage of Participants With Improvement in Clinical Global Impressions-Improvement (CGI-I)|"The Clinical Global Impression - global improvement assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, markedly improved; 2, moderately improved; 3, minimally improved; 4, no change; 5, minimally worsened; 6, moderately worsened; or 7, markedly worsened.
Improvement is defined as a score of 1 or 2."|Baseline and Week 6|Full analysis set; Last observation carried forward (LOCF) imputation was used.||percentage of participants|||Number
668527|NCT01725282|Secondary|Change From Baseline in Hamilton Rating Score for Depression (HAM-D17)|The 17-item Hamilton Depression Scale (HAM-D17) is a clinician-rated 17-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score range is from 0 to 52 where a higher score indicates a greater depressive state.|Baseline and Week 6|Full analysis set; Last observation carried forward (LOCF) imputation was used.||units on a scale||Standard Deviation|Mean
668528|NCT01725282|Primary|Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.|Baseline and Week 6|Full Analysis Set: Participants who met the following requirements: major depressive disorder confirmed at registration; at least one dose of the study drug for the treatment period was administered; and at least one efficacy variable was assessed after the start of treatment. Last observation carried forward (LOCF) imputation was used.||units on a scale||Standard Error|Least Squares Mean
668529|NCT01725217|Secondary|Percentages of Subjects Reporting Unsolicited Adverse Events (AEs) After MenACWY-CRM Vaccination|Safety was assessed in terms of percentages of subjects who reported all the adverse events (AEs) occurring from day 1 through 7, medically attended AEs, SAEs and AEs resulting in premature withdrawal, from day 1 through 29, after MenACWY-CRM vaccination, overall and by age group|AEs occurring from day 1 through 7, medically attended AEs, SAEs and AEs resulting in premature withdrawal, from day 1 through 29|Analysis was done on safety dataset||percentage of subjects|||Number
668726|NCT01721096|Secondary|All Revascularization|All revascularization includes ischemia driven and non-ischemia driven revascularization.|8 months post index procedure|||percentage of participants|||Number
668530|NCT01725217|Secondary|Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination|Safety was assessed as the percentages of subjects aged ≥6 years who reported solicited local and systemic AEs within days 1 through 7 after MenACWY-CRM vaccination, overall and by age group|Within days 1 through 7 postvaccination|Analysis was done on safety dataset||Percentage of Subjects|||Number
668531|NCT01725217|Secondary|Percentages of Subjects Aged 2 Through 5 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination|Safety was assessed as the percentages of subjects aged 2 through 5 years who reported solicited local and systemic AEs within days 1 through 7 after MenACWY-CRM vaccination|Within days 1 through 7 postvaccination|Analysis was done on safety dataset, i.e. all subjects in the exposed population who provided any post-baseline safety data||Percentage of subjects|||Number
668532|NCT01725217|Secondary|Percentages of Subjects With hSBA Titer ≥1:8 at Baseline and After MenACWY-CRM Vaccination|Immunogenicity was measured as the percentages of subjects with hSBA titer ≥1:8, at baseline (day 1) and 28 days after MenACWY-CRM vaccination (day 29), overall and by age group|Days 1 and 29|Analysis was done on FAS dataset||Percentage of Subjects||95% Confidence Interval|Number
668533|NCT01725217|Secondary|Geometric Mean Titers (GMTs) of Subjects at Baseline and After MenACWY-CRM Vaccination|Immunogenicity was measured as hSBA GMTs, against N meningitidis serogroups A, C, W and Y, at baseline (day 1) and 28 days after MenACWY-CRM vaccination (day 29), overall and by age group|Days 1 and 29|Analysis was done on FAS dataset||human serum bactericidal assay titer||95% Confidence Interval|Geometric Mean
668534|NCT01725217|Secondary|Percentages of Subjects With Seroresponse After MenACWY-CRM Vaccination, by Age Group|Immunogenicity was measured as the percentages of subjects stratified by age group with hSBA response, directed against N meningitidis serogroups A, C, W and Y, 28 days after one vaccination of MenACWY-CRM|Day 29|Analysis was done on FAS dataset||Percentage of subjects||95% Confidence Interval|Number
668535|NCT01725217|Primary|Percentages of Overall Subjects With Seroresponse After MenACWY-CRM Vaccination|"Immunogenicity was measured as the percentages of overall subjects with hSBA (human serum bactericidal assay) seroresponse, directed against Neisseria meningitidis (N meningitidis) serogroups A, C, W and Y, 28 days after one vaccination of MenACWY-CRM (day 29).
The seroresponse is defined as the percentages of subjects achieving hSBA ≥1:8 postvaccination with a prevaccination hSBA <1:4 and the percentages of subjects achieving at least four-fold increases in postvaccination hSBA from day 1 in subjects with a baseline hSBA ≥1:4"|Day 29|Analysis was done on Full Analysis Set (FAS), i.e., all subjects in the exposed population who provided one evaluable serum sample whose assay result is available for at least one serogroup at baseline and at day 29||Percentage of subjects||95% Confidence Interval|Number
668536|NCT01724528|Other Pre-specified|Treatment Emergent Signs or Symptoms (TESS)|Incidence, severity, seriousness and treatment-causality of TESS|14 ± 2 days||||||
668537|NCT01724528|Secondary|Assessment of Clinical Tumor Lysis Syndrome (CTLS)|Assessment of CTLS, from Day 3 to Day 8. According to Cairo-Bishop definition, CTLS is defined by the presence of LTLS in addition to 1 or more of the following significant clinical complications: renal insufficiency, cardiac arrhythmias, sudden death and seizures. The grade of CTLS is defined by the maximal grade of the clinical manifestation|6 days|ITT; no imputation applied||% of patients with CTLS occurrence|||Number
668538|NCT01724528|Secondary|Assessment of Laboratory Tumor Lysis Syndrome (LTLS)|Assessment of LTLS, from Day 3 to Day 8. According to Cairo-Bishop definition LTLS is defined by the presence of 2 or more laboratory abnormalities including: a 25% increase or levels above normal for serum uric acid, potassium, and phosphate or a 25% decrease or levels below normal for calcium.|6 days|ITT; no imputation applied||% of patients with LTLS occurrence|||Number
668539|NCT01724528|Secondary|Treatment Responder Rate|Assessment of treatment responder rate, where treatment response is defined as the maintenance of sUA ≤ 7.5 mg/dL from Day 3 to Day 8|6 days|Intention to Treat (ITT; no imputation applied||% of patients who fail to respond|||Number
668540|NCT01724528|Primary|Preservation of Renal Function|Change in serum creatinine level from baseline (Day 1) to the evaluation visit (Day 8)|8 days|ITT. Sample size calculation: no change in mean serum creatinine level from baseline to the end of treatment for febuxostat group while allopurinol has a increase of 13%; 340 patients were sufficient to achieve approximately 80% power. Imputation method: LOCF; missing baseline values were not replaced||change %||Standard Deviation|Mean
668541|NCT01724528|Primary|Serum Uric Acid (sUA) Level Control|Area under the curve of sUA from baseline (Day 1) to the evaluation visit (Day 8)|8 days|Intention to treat (ITT), defined as all randomized patients. Sample size calculation: at least an absolute reduction of 100 mg x h/dL for the AUCsUA1-8 in favour of febuxostat; 340 patients were sufficient to achieve approximately 80% power. Imputation method: last observation carried forward (LOCF); missing baseline values were not replaced.||mg x hour/dL||Standard Deviation|Mean
668542|NCT01724359|Secondary|Daytime Drowsiness Evaluation Scale|This self-administered scale rates the daytime drowsiness. Patients will indicate on an 11-point scale how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 10 (all the time).|Baseline, Week 26|All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.||scores on a scale||Standard Deviation|Mean
668543|NCT01724359|Secondary|Sleep Evaluation Scale|This self-administered scale rates the quality of sleep. Patients will indicate on an 11-point scale how well they have slept in the previous 7 days, from 0 (very badly) to 10 (very well).|Baseline, Week 26|All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.||scores on a scale||Standard Deviation|Mean
668544|NCT01724359|Secondary|Health Status as Measured by Self-rated Health Status Survey SF-36|The SF-36 is designed to examine a person’s perceived health status. The SF-36 includes one multi-item scale measuring eight health concepts: vitality, physical functioning, bodily pain, general health perceptions, physical role-, emotional role-, social role functioning, and mental health. Answers to each question are scored and summed to produce raw scale scores for each health concept which are then transformed to a 0 – 100 scale, a high score defining a more favorable health state. An aggregate summary measure is calculated by averaging the scores from the eight health concepts.|Baseline, Week 26|All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.||scores on a scale||Standard Deviation|Mean
668727|NCT01721096|Secondary|Non-target Vessel Revascularization (Non-TVR)|Any revascularization in a vessel other than the target vessel is considered a non-target vessel revascularization.|1 year post index procedure|||percentage of participants|||Number
668545|NCT01724359|Secondary|Personal and Social Performance (PSP) Scale|This PSP assesses the degree of a patient’s dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (i, absent to vi, very severe) in each of the 4 domains. Based on the four domains there will be one total score. Patients with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; =< 30, functioning so poorly as to require intensive supervision.|Baseline, Week 26|All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.||scores on a scale||Standard Deviation|Mean
668546|NCT01724359|Secondary|Clinical Global Impression-Severity (CGIS)|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a patient. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill patients. Higher scores indicate worsening."|Baseline, Week 26|All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.||participants|||Number
668547|NCT01724359|Secondary|Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) - General Psychopathology Subscale Score|The PANSS General Psychopathology Subscale Score assesses 16 general psychopathology symptoms. The symptoms are rated on a 7-point scale, with a range of 16 (absent) to 112 (extreme psychopathology).|Baseline, Week 26|All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.||scores on a scale||Standard Deviation|Mean
668548|NCT01724359|Secondary|Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score|The PANSS Negative Subscale assesses seven negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).|Baseline, Week 26|All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.||scores on a scale||Standard Deviation|Mean
668549|NCT01724359|Secondary|Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score|The PANSS Positive Subscale assesses seven positive-symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).|Baseline, Week 26|All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.||scores on a scale||Standard Deviation|Mean
668550|NCT01724359|Primary|Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) Score|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Baseline, Week 26|All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.||scores on a scale||Standard Deviation|Mean
668551|NCT01724216|Primary|Number of Head Images Successfully Collected|Collect head human images and associated technical and clinical information to demonstrate neurological magnetic resonance imaging of subjects using short pulse sequence.|6-months|||Images|Participants||Number
668552|NCT01724177|Secondary|Number of Participants With Adverse Events|Treatment Emergent Adverse Event (TEAE) was defined as any AE occurring on or after the start of study treatment and within 28 days after the last dose. Severity was assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0): Grade 1= Mild Grade 2= Moderate Grade 3= Severe Grade 4= Life-threatening and Grade 5= Death related to AE. Serious AEs (SAEs) were those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above.|Up to data cutoff of 20 November 2014; maximum time on study treatment was 79.7 weeks|Safety population was defined as all participants who received at least one dose of lenalidomide. All safety analyses were based on the safety population.||participants|||Number
668553|NCT01724177|Secondary|Kaplan-Meier Estimate for Overall Survival|Overall Survival was defined as the time from the start of study treatment to the death due to any cause. For participants who were still alive at the time of the data cutoff, survival data were censored at the latest available date the participant was known to be alive.|Up to the data cut-off date of 20 November 2014; maximum time on study treatment was 79.7 weeks|The EE population consisted of all participants who met basic protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of lenalidomide.||weeks||95% Confidence Interval|Median
668554|NCT01724177|Secondary|Percentage of Participants Who Had a Achieved a CR, CRu, PR or Stable Disease (SD) as Assessed by the ESEC|The tumor control rate was measured for those with a response of Complete Remission, + CRu, + PR + Stable Disease (SD) in the EE population based on the best responses.|Up to the data cut-off of 20 November 2014; maximum time on study treatment was 79.7 weeks|The EE population consisted of all participants who met basic protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of lenalidomide||percentage of participants||95% Confidence Interval|Number
668555|NCT01724177|Secondary|Kaplan-Meier Estimate of Duration of Response (DOR) for Responders|The response duration in participants with an objective response was measured from the date of the first Complete Response or Complete Response unconfirmed or Partial Response to the first date of Relapsed Disease or Progressive Disease (PD). For participants who did not progress during the study, DOR was censored at the last adequate response assessment not showing evidence of PD.|Up to data cut-off of 20 Nov 2014; maximum time on study treatment was 79.7 weeks|The duration of response population consisted of participants who had an objective response.||weeks||95% Confidence Interval|Number
668556|NCT01724177|Secondary|Kaplan-Meier Estimate of Time to Progression (TTP)|Time to progression was calculated as the time from the first dosing of study treatment to the first documented PD and assessed by the ESEC|Up to data cut-off of 20 November 2014; maximum time on study treatment was 79.7 weeks|The EE population consisted of all participants who met basic protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of lenalidomide||weeks||95% Confidence Interval|Median
668557|NCT01724177|Secondary|Kaplan Meier Estimate of Progression Free Survival (PFS) Assessed by ESEC|PFS was defined as the time from the first dose of study treatment to progressive disease (PD) or death due to any cause on study or within 28 days after study discontinuation, whichever occurred earlier.|Up to the cut-off date of 20 November 2014; maximum time on study treatment was 79.7 weeks|The EE population consisted of all participants who met basic protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of lenalidomide||weeks||95% Confidence Interval|Median
668558|NCT01724177|Primary|Overall Response Rate (ORR) Based on the Adult T-cell Leukemia-lymphoma (ATLL) Response Criteria and Assessed by the Efficacy-Safety Evaluation Committee (ESEC)|ORR is a Complete Response (CR) + Complete Response unconfirmed (CRu) + Partial Response (PR). A CR requires that target lesions have regressed to normal; nodal non-target lesions have regressed to normal; extranodal non-target lesions have disappeared; hepatomegaly/splenomegaly has disappeared; skin findings are GR 0; peripheral blood is normal; Bone marrow (BM) infiltration is negative and no new lesions. A CRu requires the sum of the product diameters (SPD) of target lesions have decreased by at least 75% from baseline; nodal non-target lesions have regressed to normal size; extranodal non-target lesions have disappeared; hepatomegaly/splenomegaly has disappeared; skin findings are Grade 0; peripheral blood is normal; BM infiltration is “negative” and no new lesions. A PR requires the SPD of target lesions has decreased by at least 50% from baseline; all nodal non-target lesions have regressed to normal or show no increase in size; all extranodal non-target lesions have disappeared|Up to the data cut-off of 20 November 2014; maximum time on study treatment was 79.7 weeks|The Efficacy evaluable (EE) population consisted of all participants who met basic protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of lenalidomide||percentage of participants||95% Confidence Interval|Number
668559|NCT01724021|Secondary|Summary of Observed Serum Rituximab Concentration||pre-dose Cycle 1 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (approximately 25 months)|The safety population included all participants who received at least one dose of rituximab. Here, n specifies the number of participants who were evaluable at specified time points.||microgram per milliter||Standard Deviation|Mean
668560|NCT01724021|Secondary|Percentage of Participants With Anti-Recombinant Human Hyaluronidase (rHuPH20) Antibodies Over Time||pre-dose Cycle 2 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (approximately 25 months)|The safety population included all participants who received at least one dose of rituximab. Here, n specifies the number of participants who were evaluable at specified time points.||percentage of participants|||Number
668561|NCT01724021|Secondary|Percentage of Participants With Anti-Rituximab Antibodies Over Time||pre-dose Cycle 1 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (approximately 25 months)|The safety population included all participants who received at least one dose of rituximab. Here, n specifies the number of participants who were evaluable at specified time points.||percentage of participants|||Number
668562|NCT01724021|Secondary|Overall Survival (OS)|OS was defined as the time from randomization to death from any cause.|From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (approximately 25 months)|ITT population included all participants who were randomized in the study.||months||95% Confidence Interval|Median
668563|NCT01724021|Secondary|Progression-free Survival (PFS)|PFS was defined as the time from randomization to the first occurrence of progression or relapse, according to the IWG response criteria. IWG criteria is defined criteria using the following response categories: CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy; PR: At least a 50% decrease in SPD of up to six of the largest dominant nodes or nodal masses; SD: participants fails to attain the criteria needed for a CR or PR, but does not fulfill those for PD; PD: Lymph nodes considered abnormal if the long axis is more than 1.5 cm regardless of the short axis. Lymph node has a long axis of 1.1 to 1.5 cm, it is considered abnormal if its short axis is more than 1.0. Lymph nodes <= 1.0 × <= 1.0 cm would not be considered as abnormal for PD.|From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (approximately 25 months)|ITT population included all participants who were randomized in the study.||months||95% Confidence Interval|Median
668564|NCT01724021|Secondary|Disease-free Survival (DFS)|DFS was defined as the period from the data of the initial CR/CRu until the date of relapse or death from any cause, whichever occurred first.|From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (approximately 25 months)|ITT population included all participants who were randomized in the study.||months||95% Confidence Interval|Median
668565|NCT01724021|Secondary|Event-free Survival (EFS)|EFS was defined as the time from randomization to first occurrence of progression or relapse according to IWG response criteria. IWG criteria is defined using the following response categories: CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy; partial response (PR): At least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses; stable disease (SD): participants fails to attain the criteria needed for a CR or PR, but does not fulfill those for progressive disease (PD); PD: Lymph nodes considered abnormal if the long axis is more than 1.5 centimeter (cm) regardless of the short axis. Lymph node has a long axis of 1.1 to 1.5 cm, it is considered abnormal if its short axis is more than 1.0. Lymph nodes less than or equal to (<=) 1.0 × <= 1.0 cm would not be considered as abnormal for PD.|From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (approximately 25 months)|ITT population included all participants who were randomized in the study.||months||95% Confidence Interval|Median
668576|NCT01723904|Primary|Change From Baseline to the End of the Treatment Period in Absolute Time Spent “Off”|"Absolute time spent off is measured in hours per day. A negative value in Change from Baseline to Week 8 indicates that the time spent off decreased from Baseline and therefore indicates an improvement from Baseline.
Only subjects with time spent off at Baseline (subset of the Full Analysis Set (FAS)) are included in the analysis of this outcome measure."|From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)|"Subjects with time spent off at Baseline in the FAS with Last Observation Carried Forward (LOCF) as a method of imputation for missing observations. FAS includes all subjects with at least 1 patch application during Treatment Period, and with an evaluable UPDRS Part III total score at Baseline and at least 1 valid value after Baseline to Day 64."||hours/day||Standard Deviation|Mean
668566|NCT01724021|Secondary|Complete Response (CR) Rate|CR rate was assessed according to the International Working Group (IWG) Response Criteria (CHESON ET AL. 1999) and included CR and CR unconfirmed (CRu). CR was defined as complete disappearance of all clinical and radiographic evidence of disease and disease-related symptoms, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. CRu was defined as disappearance of clinical and radiographic evidence of disease and absence of splenomegaly, with regression of lymph nodes by > 75 % but still >1.5 cm in size, and indeterminate bone marrow assessment. Tumor assessments were based on computed tomography (CT) scans with contrast of the neck, chest, and abdomen (if detectable by these techniques) or other diagnostic means, if applicable. Other methods (e.g., MRI) were acceptable for participants in whom contrast CT scans were contraindicated. Due to the limited availability of FDG-PET scanners, an FDG-PET scan was not mandated in the study.|28 days (± 3 days) after Day 1 of the last dose of induction treatment|ITT population included all participants who were randomized in the study. Number of participants analyzed specifies number of participants who were evaluable for the outcome measure.||percentage of participants||95% Confidence Interval|Number
668567|NCT01724021|Secondary|Rituximab Administration Satisfaction Questionnaire (RASQ) Score|The RASQ is a 20-item questionnaire that measures five domains related to the impact of treatment administration. These include physical impact, psychological impact, impact on activities of daily living (ADLs), convenience, and satisfaction. Each domain is scored on a scale of 0 to 100, with higher scores indicative of more positive feelings toward therapy. The score for each domain was averaged among all participants.|During cycle 4, 8 of treatment (up to 32 weeks)|ITT population included all participants who were randomized in the study. Here, n specifies the number of participants who were evaluable at specified time points.||units on a scale||Standard Deviation|Mean
668568|NCT01724021|Secondary|Cancer Therapy Satisfaction Questionnaire (CTSQ) Score|CTSQ is a validated 16-item questionnaire that measures three domains related to participants’ satisfaction with cancer therapy. These include expectations of therapy, feelings about side effects, and satisfaction with therapy. Each domain is scored on a scale of 0 to 100, with higher scores indicative of more positive feelings toward therapy. The score for each domain was averaged among all participants.|During cycle 4, 8 of treatment (up to 32 weeks)|ITT population included all participants who were randomized in the study. Here, n specifies the number of participants who were evaluable at specified time points.||units on a scale||Standard Deviation|Mean
668569|NCT01724021|Secondary|Time Required for Rituximab Administration (Subcutaneous [SC] or Intravenous [IV])|Administration time was defined as the time from start to end of the SC injection or from start to end of the IV infusion|Cycle 2-4, cycle 5-8 for both SC and IV (up to 32 weeks)|ITT population included all participants who were randomized in the study.||minutes||Full Range|Median
668570|NCT01724021|Secondary|Number of Participants With Treatment Emergent Adverse Events (AEs)|An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Randomization of first participant to clinical cutoff (approximately 25 months)|The safety population included all participants who received at least one dose of rituximab.||participants|||Number
668571|NCT01724021|Primary|Percentage of Participants Indicating a Preference for Rituximab Subcutaneous (SC) Over Rituximab Intravenously (IV) at Cycle 8|Participants who preferred rituximab SC over rituximab IV, along with the corresponding 95% confidence interval (CI), were estimated using the patient preference questionnaire (PPQ) after completing cycle 8.|Cycle 8 (up to 32 weeks)|ITT population included all participants who were randomized in the study.||percentage of participants||95% Confidence Interval|Number
668572|NCT01724021|Primary|Percentage of Participants Indicating a Preference for Rituximab Subcutaneous (SC) Over Rituximab Intravenously (IV) at Cycle 6|Participants who preferred rituximab SC over rituximab IV, along with the corresponding 95% confidence interval (CI), were estimated using the patient preference questionnaire (PPQ) after completing cycle 6.|Cycle 6 (up to 24 weeks)|ITT population included all participants who were randomized in the study.||percentage of participants||95% Confidence Interval|Number
668573|NCT01723904|Secondary|Change From Baseline to the End of Treatment Period in the Pittsburgh Sleep Quality Index (PSQI) Global Score|"The Pittsburgh Sleep Quality Index (PSQI) is a questionnaire with 18 questions to assess sleep quality. The 18 questions are distributed to 7 elements with each element ranging from 0-3. The global score is the sum score of all 7 elements and ranges from 0-21 with higher values indicating worse sleep quality.
A negative value in Change from Baseline to Week 8 indicates an improvement in sleep quality from Baseline."|From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF) as a method of imputation for missing observations. FAS includes all subjects with at least 1 patch application during Treatment Period, and with an evaluable UPDRS Part III total score at Baseline and at least 1 valid value after Baseline to Day 64.||units on a scale||Standard Deviation|Mean
668574|NCT01723904|Secondary|Change From Baseline to the End of Treatment Period in Parkinson’s Disease Sleep Scale 2 (PDSS-2) Total Score|"The Parkinson´s Disease Sleep Scale (PDSS) is a questionnaire with 15 questions to assess sleep disturbance and nocturnal disability in Parkinson´s disease. The item- scores can range between 0= never and 4= very often. The PDSS score is a sum score of all 15 questions.
A negative value in Change from Baseline to Week 8 indicates an improvement from Baseline."|From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF) as a method of imputation for missing observations. FAS includes all subjects with at least 1 patch application during Treatment Period, and with an evaluable UPDRS Part III total score at Baseline and at least 1 valid value after Baseline to Day 64.||units on a scale||Standard Deviation|Mean
668575|NCT01723904|Secondary|Change From Baseline to the End of the Treatment Period in Time Spent “on” Without Troublesome Dyskinesia|"Absolute time spent on without troublesome dyskinesia is measured in hours per day. A positive value in Change from Baseline to Week 8 indicates that the time spent on without troublesome dyskinesia increased from Baseline and therefore indicates an improvement from Baseline."|From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF) as a method of imputation for missing observations. FAS includes all subjects with at least 1 patch application during Treatment Period, and with an evaluable UPDRS Part III total score at Baseline and at least 1 valid value after Baseline to Day 64.||hours/day||Standard Deviation|Mean
668577|NCT01723904|Primary|Change From Baseline to the End of the Treatment Period in the Unified Parkinson’s Disease Rating Scale (UPDRS) Part II (Average of “on” and “Off” State) Total Score|"UPDRS Part II measures 'Activities in Daily Living'. The total score ranges from 0 (Best score possible) to 52 (Worst score possible).
UPDRS Part II total score (average of on and off state) is the average of UPDRS Part II total score (“on” state) and Part II total score (“off” state).
A negative value in Change from Baseline to Week 8 indicates an improvement in activities in daily living from Baseline."|From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF) as a method of imputation for missing observations. FAS includes all subjects with at least 1 patch application during Treatment Period, and with an evaluable UPDRS Part III total score at Baseline and at least 1 valid value after Baseline to Day 64.||units on a scale||Standard Deviation|Mean
668578|NCT01723904|Primary|Change From Baseline to the End of the Treatment Period in the Unified Parkinson’s Disease Rating Scale (UPDRS) Part III (“on” State) Total Score|"The Unified Parkinson´s Disease Rating Scale Part III is an accepted and validated scale for the assessment of motor function in Parkinson´s disease. Each of the 27 sub-items in the UPDRS III is measured on a scale of 0 to 4, where 0 is normal and 4 represents severe abnormalities. The total scores therefore ranges from 0 to 108.
A negative value in Change from Baseline to Week 8 indicates an improvement in motor functions from Baseline."|From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF) as a method of imputation for missing observations. FAS includes all subjects with at least 1 patch application during Treatment Period, and with an evaluable UPDRS Part III total score at Baseline and at least 1 valid value after Baseline to Day 64.||units on a scale||Standard Deviation|Mean
668579|NCT01723904|Primary|Clinical Global Impression (CGI) Item 4 (Side Effects) at the End of the Treatment Period|"The CGI Item 4 was used to assess side effects. It ranges from 0 to 4 as follows: 0 = Side effects not assessable
= No side effects
= Side effects do not significantly interfere with subject's functioning
= Side effects significantly interfere with the subject's functioning
= Side effects outweigh therapeutic efficacy."|Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)|From the 90 subjects in the Safatey Set, 89 are included in the analysis of this outcome measure. Last Observation Carried Forward (LOCF) was used as a method of imputation for missing observations.||participants|||Number
668580|NCT01723722|Primary|Length of Treatment With Opioid Medication|Up to 12 months|Up to 12 months|Completion of treatment||days||Standard Deviation|Mean
668581|NCT01723397|Primary|Change in Total Nasal Symptom Score After Nasal Challenge With Allergen Versus Diluent|Change in total nasal symptom score after nasal challenges (the change is calculated as the total nasal symptom score after allergen challenge - total nasal symptom score after diluent challenge) on the second of two days of nasal challenges following one week of pretreatment with Nasaleze or placebo. The nasal symptoms included number of sneezes, symptoms of runny and stuffy nose (separately for each nostril), and itchy nose/throat symptoms. Individual symptoms were score on a scale from 0-3 (0=no symptoms, 1=mild, 2=moderate, 3=severe). The maximum total nasal symptom score possible was 15 with higher scores indicating worse symptoms.|Day 2 after one week pretreatment with Nasaleze or placebo.|The analysis population includes the 12 participants who completed the study.||units on a scale||Full Range|Median
668582|NCT01723254|Secondary|Enzyme-Linked Immunosorbent Assay (ELISA) Measured Anti-IgE Geometric Mean Titers (GMTs) at Baseline, Day 182, and Day 336|Ability of vaccine induced serum anti-immunoglobulin E (IgE) antibodies to interfere with IgE binding to recombinant alpha chain of the high affinity IgE receptor was assessed in an ELISA based assay. GMTs were calculated both as crude means (unadjusted) and by an analysis of covariance (ANCOVA) model with natural log transformed antibody titer as outcome variable, and treatment group as factor and baseline (in log scale) as covariates at each of the post dose measurement.|Baseline (Day 1), Day 182 (2 weeks after last vaccination), and end of study (Day 336)|All randomized participants who received at least 1 dose of randomized treatment, n=number of evaluable participants at the specified time point.||units/milliliter (u/mL)||80% Confidence Interval|Number
668583|NCT01723254|Primary|Number of Participants With Laboratory Test Abnormalities|Number of participants with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters included hematology, coagulation, liver function, renal function, electrolytes, hormones, clinical chemistry, immunology urinalysis, urinalysis (dipstick and microscopy), and other tests such as human immunodeficiency virus antibody and hepatitis C antibody.|Baseline up to 336 days post last study drug administration or Early Termination|All randomized participants who received at least one dose of study treatment.||participants|||Number
668584|NCT01723254|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations From Treatment Due to TEAEs|An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs comprised both SAEs and non-SAEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Severe TEAEs were those that interfered significantly with the participant's usual function. Causality assessment was made by the investigator.|Baseline up to 336 days post study administration or at Early Termination|All randomized participants who received at least one dose of study treatment.||participants|||Number
668585|NCT01723254|Primary|Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination|Systemic reactions consisted of fever, vomiting, diarrhea, headache, fatigue, muscle pain (other than at the injection site) and joint pain (other than pain adjacent to injection site). Participants were issued an electronic diary (e-diary) and were asked to monitor and record (according to corresponding grading scales) any systemic reactions for 14 days following each vaccination. Grading details are as follows: Mild (Vomiting: 1-2 times in 24 hours; Diarrhea: 2-3 loose stools in 24 hours; Headache, Fatigue, Muscle Pain, Joint Pain: no interference with activity), Moderate (Vomiting: >2 times in 24 hours; Diarrhea: 4-5 loose stools in 24 hours; Headache, Fatigue, Muscle and Joint Pain: some interference with activity), Severe (Vomiting: required intravenous hydration; Diarrhea: more than or equal to [>=] 6 stool in 24 hours; Headache, Fatigue, Muscle and Joint Pain: Significant, prevented daily activity).|Within 14 days|All randomized participants who received at least one dose of study treatment.||Percentage of participants||80% Confidence Interval|Number
668586|NCT01723254|Primary|Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination|Local reactions consisted of any pain at the site of injection, any swelling, and any redness. Participants were issued an electronic diary (e-diary) and were asked to monitor and record (according to corresponding grading scales) any local reactions for 14 days following each vaccination. Grading details are as follows: Mild (Pain: did not interfere with activity; Redness and Swelling: 0.5-5.0 centimeters [cm] or 1-10 caliper units), Moderate (Pain: interfered with activity; Redness and Swelling: more than [>] 5.0 to 10.0 cm or 11-20 caliper units), Severe (Pain: prevented daily activity; Redness and Swelling: >10 cm or 21 caliper units and above).|Within 14 days|All randomized participants who received at least one dose of study treatment.||Percentage of participants||80% Confidence Interval|Number
668587|NCT01723228|Secondary|Change From Baseline to Week 24 in UPDRS, Activities of Daily Living (ADL) Subscale (Part 2), Version 3, Score|UPDRS Part 2 (ADL subscale) comprises 13 items evaluating the impact of PD on patients' ADL (in both the on and off states) in the week prior to the visit. The following 13 ADL are assessed: speech, salivation, swallowing, handwriting, cutting food and handling utensils, dressing, hygiene, turning in bed and adjusting bed clothes, falling (unrelated to freezing), freezing when walking, walking, tremor, and sensory complaints related to Parkinsonism. Each item is assessed on a scale from 0 (normal, absent, or none) to 4 (severe impairment), which are summed to get the sub-scale score. The total scale is 0-52 with a higher score indicating more severe symptoms; a decrease in the scores indicates improvement.|Baseline to week 24 (or early discontinuation)|Modified intent-to-treat population: all participants who were randomized, received at least 1 dose of study drug and had at least 1 postbaseline UPDRS ADL Subscale (Part 2) assessment.||units on a scale||Standard Error|Least Squares Mean
668588|NCT01723228|Secondary|Change From Baseline to Week 24 in the Unified Parkinson's Disease Rating Scale (UPDRS), Motor Subscale (Part 3), Version 3, Score|UPDRS Part 3 (motor examination subscale) comprises 14 items assessing the motor disabilities of the patient at the time of the visit. The participant's speech, facial expressions, ability to arise from a chair (with arms folded), posture, gait, postural stability (retropulsion test), and body bradykinesia and hypokinesia are assessed. In addition, the following evaluations require assessment of the face, neck or extremities: tremor at rest, action or postural tremor of hands, rigidity, finger taps, hand movements (open and close), rapid alternating movements of hands (pronation and supination), and leg agility (tap heel on ground). This evaluation is performed while the participant is in the 'on' phase. Each item is assessed on a scale from 0 (normal, absent, or none) to 4 (severe impairment), which are summed to get the sub-scale score. The total scale is 0-57 with a higher score indicating more severe symptoms; a decrease in the scores indicates improvement.|Baseline to Week 24 (or early discontinuation)|Modified intent-to-treat population: all participants who were randomized, received at least 1 dose of study drug and had at least 1 postbaseline UPDRS Motor Subscale (Part 3) assessment.||units on a scale||Standard Error|Least Squares Mean
668589|NCT01723228|Secondary|Alzheimer's Disease Cooperative Study's Clinical Global Impression of Change Modified for Mild Cognitive Impairment (ADCS MCI-CGIC) Score at Week 24|The ADCS MCI-CGIC score is generated in the context of a semi-structured interview and is an indication of the change in the participant's global status, cognition, behavior, and functional abilities (FA) on a 7-point scale, with the best score being 'marked improvement' and the worst being 'marked worsening.'|Week 24 (or early discontinuation)|Modified intent-to-treat population: all participants who were randomized, received at least 1 dose of study drug and had at least 1 postbaseline ADCS MCI-CGIC assessment. n=number of participants with the given assessment.||participants|||Number
668590|NCT01723228|Secondary|Change From Baseline to Week 24 in the Penn Daily Activities Questionnaire (PDAQ) Score|The PDAQ is a 15-item questionnaire that assesses the patient’s difficulty with activities of daily living. The total score has a range of 0 (no impairment) to 60 (severe impairment).|Baseline to Week 24 (or early discontinuation)|Modified intent-to-treat population: all participants who were randomized, received at least 1 dose of study drug and had at least 1 postbaseline PDAQ assessment.||units on a scale||Standard Error|Least Squares Mean
668591|NCT01723228|Secondary|Change From Baseline to Week 24 in the Montreal Cognitive Assessment (MoCA) Score|The MoCA assesses 8 cognitive areas: visuospatial/executive, naming, memory, attention, language, abstraction, delayed recall, and orientation. Scores range from 0 (worst) to 30 (best).|Baseline to Week 24 (or early discontinuation)|Modified intent-to-treat population: all participants who were randomized, received at least 1 dose of study drug and had at least 1 postbaseline MoCA assessment.||units on a scale||Standard Error|Least Squares Mean
668592|NCT01723228|Primary|Mean Change From Baseline to Week 24 in the Scales for Outcomes in Parkinson's Disease-Cognition (SCOPA-COG) Summary Score|The SCOPA-COG consists of evaluations in 4 domains: memory, attention, executive functioning, and visuospatial functioning.Scores range from 0 to 43, with higher scores reflecting better performance.|Baseline to Week 24 (or early discontinuation)|Modified intent-to-treat population: all participants who were randomized, received at least 1 dose of study drug and had at least 1 postbaseline SCOPA-COG assessment.||units on a scale||Standard Error|Least Squares Mean
668593|NCT01722994|Secondary|Presence of Infection|Any infected wounds were documented. A scale of 0-1 was used (0=absence; 1= present).|3 weeks|Of the 97 subjects who enrolled, 49 had punch biopsy site closure with chromic gut and 48 with polyglactin 910 sutures. 42 subjects were lost to follow-up or had missing data. Of the 55 subjects who completed the study - 24 received chromic gut and 31 received polyglactin 910.||participants|||Number
668594|NCT01722994|Primary|Presence of Scarring|All subjects will be examined 1 week and 3 weeks after the wounds are closed with absorbable suture to assess the presence or absence of scarring. A scale of 0-1 was used (0=absent; 1=present).|3 weeks|Of the 97 subjects who enrolled, 49 had punch biopsy site closure with chromic gut and 48 with polyglactin 910 sutures. 42 subjects were lost to follow-up or had missing data. Of the 55 subjects who completed the study - 24 received chromic gut and 31 received polyglactin 910.||participants|||Number
668595|NCT01722994|Secondary|Presence of Infection|Any infected wounds were documented. A scale of 0-1 was used (0=absence; 1= present).|1 week|Of the 97 subjects who enrolled, 49 had punch biopsy site closure with chromic gut and 48 with polyglactin 910 sutures. 42 subjects were lost to follow-up or had missing data. Of the 55 subjects who completed the study - 24 received chromic gut and 31 received polyglactin 910.||participants|||Number
668728|NCT01721096|Secondary|Non-target Vessel Revascularization (Non-TVR)|Any revascularization in a vessel other than the target vessel is considered a non-target vessel revascularization.|8 months post index procedure|||percentage of participants|||Number
668596|NCT01722994|Secondary|Length of Time Till Absorbable Suture Fall Out|The time post placement when the suture fell out.|3 weeks|Of the 97 subjects who enrolled, 49 had punch biopsy site closure with chromic gut and 48 with polyglactin 910 sutures. 42 subjects were lost to follow-up or had missing data. Of the 55 subjects who completed the study - 24 received chromic gut and 31 received polyglactin 910.||Days||Standard Deviation|Mean
668597|NCT01722994|Primary|Presence of Scarring|All subjects will be examined 1 week and 3 weeks after the wounds are closed with absorbable suture to assess the presence or absence of scarring. A scale of 0-1 was used (0=absent; 1=present).|1 week|Of the 97 subjects who enrolled, 49 had punch biopsy site closure with chromic gut and 48 with polyglactin 910 sutures. 42 subjects were lost to follow-up or had missing data. Of the 55 subjects who completed the study - 24 received chromic gut and 31 received polyglactin 910.||participants|||Number
668598|NCT01722877|Other Pre-specified|Acute Device Success|Acute device success is defined as less than or equal to 50% residual stenosis at the index lesion using the JetStream device alone and with no adjunctive balloon angioplasty therapy (via Quantitative Vascular Analysis) and with no serious adverse events.|intraprocedural|||limbs|limbs||Count of Units
668599|NCT01722877|Secondary|Target Lesion Revascularization|Reintervention on the same index lesion at 6 months|6 months|||lesions|lesions||Count of Units
668600|NCT01722877|Secondary|Patency|Patency is defined as Peak Systolic Velocity Ratio (PSVR) of < 2.4 by duplex criteria. PSVR is obtained by dividing velocity (cm/sec) at the lesion site to the velocity immediately proximal to the lesion.|6 months|||limbs|limbs||Count of Units
668601|NCT01722877|Primary|Acute Procedural Success|Acute procedural success is defined as less than or equal to 30 percent residual stenosis (via Quantitative Vascular Analysis) at the index lesion post JestStream atherectomy and final adjunctive treatment And with no serious adverse events.|intraprocedural|||limbs|limbs||Count of Units
668602|NCT01722734|Primary|Self-reported Adherence to Artemisinin-combination Therapy (ACT) Treatment|Percentage of participants completing full ACT treatment regimen 70 hours after treatment initiation. Subjects were visited at home, and asked to report when each of the prescribed six doses were taken. Adherence was defined as the (self-reported) completion of all six doses.|70 hours|The number of subjects analyzed is smaller than the number of subjects enrolled due to missing data on adherence. A total of 30 observations were lost due to missing information on adherence - 16 in the control group, 9 in the short message group, and 5 in the long message group.||percentage of participants||95% Confidence Interval|Number
668603|NCT01722552|Secondary|Proportion of Subjects Who Achieve >/= 95% Cumulative Adherence Over Entire 6 Months of Intervention Period|Subjects will participate in the 6-month real-time feedback intervention. Comparison patients will continue to be monitored by Wisepill, but they will remain blinded to the adherence information generated by the Wisepill devices, as will their care providers.|6 months|||Participants|||Count of Participants
668604|NCT01722552|Primary|Difference in Proportion of Subjects Who Achieve >/= 95% Adherence|Subjects will participate in the 6-month real-time feedback intervention. Comparison patients will continue to be monitored by Wisepill, but they will remain blinded to the adherence information generated by the Wisepill devices, as will their care providers.|Measured at 6 months after start of intervention|||Participants|||Count of Participants
668605|NCT01722487|Secondary|Proportion of Sustained Platelet Improvement in Subjects With Baseline Thrombocytopenia|In randomized subjects with baseline platelet ≤ 100 x 10^9/L, the proportion of subjects who achieved platelet >100 x 10^9/L or increase ≥50% over baseline persisted continuously for ≥56 days (8 wee without blood transfusion or growth factors.|Analysis was conducted when 15 months had elapsed after the last subject was randomized with cutoff date of 4 May 2015. The median follow-up time is 18 month.|Subjects With Baseline Thrombocytopenia||Percentage of Participants|||Number
668606|NCT01722487|Secondary|Proportion of Sustained Platelet Improvement|The proportion of subjects who achieved platelet >100 x 10^9/L or increase ≥50% over baseline and persisted continuously for ≥56 days (8 weeks) without blood transfusion or growth factors.|Analysis was conducted when 15 months had elapsed after the last subject was randomized with the cutoff date of 4 May 2015. The median follow-up time is 18 month.|Intention to treat||Percentage of Participants|||Number
668607|NCT01722487|Secondary|Proportion of Sustained Hemoglobin Improvement in Subjects With Baseline Anemia|In randomized subjects with baseline hemoglobin ≤ 11 g/dL, the proportion of subjects who achieved Hemoglobin >11 g/dL or increase ≥ 2 g/dL over baseline persisted continuously for ≥56 days (8 weeks) without blood transfusion or growth factors.|Analysis was conducted when 15 months had elapsed after the last subject was randomized with the cutoff date of 4 May 2015. The median follow-up time is 18 month.|Subjects with Baseline Anemia||Percentage of Participants|||Number
668608|NCT01722487|Secondary|Proportion of Sustained Hemoglobin Improvement|The proportion of subjects who achieved Hemoglobin >11 g/dL or increase ≥ 2 g/dL over baseline and persisted continuously for ≥56 days (8 weeks) without blood transfusion or growth factors.|Analysis was conducted when 15 months had elapsed after the last subject was randomized with the cutoff date of 4 May 2015. The median follow-up time is 18 month.|Intention to treat||Percentage of Participants|||Number
668609|NCT01722487|Secondary|ORR (Overall Response Rate)|ORR is defined as the proportion of subjects who achieved complete response (CR), complete response with incomplete marrow recovery (CRi), nodule partial response (nPR) or PR per IRC assessment. Response criteria are as outlined in the International Workshop on CLL (iwCLL) 2008 criteria with the 2012 iwCLL modification stating that treatment-related lymphocytosis in the setting of improvement in other parameters was not considered as PD and the 2013 iwCLL clarification of criteria for a partial response to therapy.|Analysis was conducted when 15 months had elapsed after the last subject was randomized with the cutoff date of 4 May 2015. The median follow-up time is 18 month.|Intention to treat||percentage of participants|||Number
668610|NCT01722487|Secondary|Overall Survival (OS)|OS is calculated for all randomized subjects as the duration of time from the date of randomization to the date of death due to any cause or the date last known alive for subjects who were not known to have died at study closure.|Analysis was conducted when 15 months had elapsed after the last subject was randomized with the cutoff date of 4 May 2015. The median follow-up time is 18 month.|Intention to treat||Months||95% Confidence Interval|Median
668662|NCT01721486|Primary|Total Pain Medication|All pain medication documented during the first 24 hours postoperatively, in mg morphine equivalents.|From time of PACU admission until 24 hours post-operatively.|Only patients receiving rescue pain medication were analyzed.||mg||Inter-Quartile Range|Median
668611|NCT01722487|Primary|PFS (Progression Free Survival)|"The primary objective of this study was to evaluate the efficacy of Ibrutinib compared with Chlorambucil based on the independent review committee (IRC) assessment of PFS
Progressive disease according to 2008 IWCLL guidelines was defined as:
Group A
Lymphadenopathy, increase ≥50%
Hepatomegaly, increase ≥50%
Splenomegaly, increase ≥50%
Blood lymphocytes, increase ≥ 50% over baseline
Group B
Platelets counts, decrease of ≥ 50% from baseline secondary to CLL
Hemoglobin, decrease of > 2 g/dL from baseline secondary to CLL"|Analysis was conducted when 15 months had elapsed after the last subject was randomized with the cutoff date of 4 May 2015. The median follow-up time is 18 month.|Intention to treat||Months||95% Confidence Interval|Median
668612|NCT01722435|Secondary|Mean Time Staying in OST|Mean time of study participation (M, SD) of patients who stayed in OST Treatment until end of study (after 18 months).|18 months|||days||Standard Deviation|Mean
668613|NCT01722435|Secondary|Mean Time to Drop-out of OST|Mean time of study participation (M, SD) until drop-out of treatment.|18 months|||days||Standard Deviation|Mean
668614|NCT01722435|Secondary|Mean Time to Complete OST|Mean time of study participation (M, SD) until Treatment completion or end of study (after 18 months).|18 months|||days||Standard Deviation|Mean
668615|NCT01722435|Primary|OST Drop-outs|Participants dropped out of OST Treatment during the study period.|18 months|||participants|||Number
668616|NCT01722435|Primary|Completion of OST|Regularly completion of OST, i.e. not being on opioid medication any more, during the study period.|18 months|||participants|||Number
668617|NCT01722266|Secondary|Insulin, C-peptide, Glucagon, GLP-1(Glucagon Like Peptide-1) and GIP(Gastric Inhibitory Polypeptide) Concentrations Following Meal Challenge.||12 weeks||||||
668618|NCT01722266|Secondary|Carbohydrate Intake||12 weeks|||grams||Standard Error|Mean
668619|NCT01722266|Secondary|Serum Acetaminophen Concentrations Following Meal Challenge||12 weeks||||||
668620|NCT01722266|Secondary|Reduction in the Area Under Curve(AUC) of Glucose Following the Meal||12 weeks||||||
668621|NCT01722266|Secondary|Percent Time Spent in Hyperglycemia and Hypoglycemia||12 weeks||||||
668622|NCT01722266|Secondary|Change in Total Insulin Dose From Baseline at 12 Weeks|Total insulin dose = Basal insulin dose plus bolus insulin dose.|Baseline and 12 weeks|||Units||Standard Error|Mean
668623|NCT01722266|Secondary|Change in Body Weight From Baseline at Week 12||Baseline and 12 weeks|||Kg||Standard Error|Mean
668624|NCT01722266|Secondary|Change in HbA1c From Baseline at 12 Weeks||Baseline and 12 Weeks|||Percent||Standard Error|Mean
668625|NCT01722266|Primary|Change in Mean Weekly Glucose Concentrations From Baseline at 12 Weeks|The primary endpoint of the study is to detect a difference from baseline in mean weekly blood glucose concentrations before and after 12 weeks of treatment in each of the Liraglutide groups.|12 Weeks|||mg/dl||Standard Error|Mean
668626|NCT01722162|Primary|Progression Free Survival (Arm B)|"Time from start of treatment to the time of progression or death, whichever occurs first
Progressive disease (target lesions): at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Progressive disease (non-target lesions): appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase."|Until progressive disease (PD) (up to 60 days)|||proportion of patients with PFS||95% Confidence Interval|Number
668627|NCT01722162|Secondary|Incidence and Severity of Adverse Events as Measured by Number of Participants Who Experience Grade 3 and Higher Adverse Events|NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0|Up to 6 months|Arm A: 4 patients not evaluable for outcome measure (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, & 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable because of noncompliance after enrollment but before treatment||participants|||Number
668628|NCT01722162|Primary|Progression Free Survival (Arm A)|"Time from start of treatment to the time of progression or death, whichever occurs first
Progressive disease (target lesions): at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Progressive disease (non-target lesions): appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase."|Until progressive disease (PD) (estimated to be 92 days)|||proportion of patients with PFS||95% Confidence Interval|Number
668629|NCT01722097|Other Pre-specified|Patient-movements|Number of unintended and unwanted patient-movements registered by the surgeon|During surgery||||||
668630|NCT01722097|Secondary|Pain (Assessed on a 0-100 Visual Analouge Scale (VAS): 0 no Pain, 100 Worst Kind of Pain)|"Pain (shoulder-, incisional-, abdominal - and overall pain) estimated as area under the curve (AUC) from 0 till 4 days after operation.
Pain (shoulder-, incisional-, abdominal - and overall pain) estimated as area under the curve (AUC) from 0 till 14 days after operation.
Pain was assessed: preoperatively, at arrival to the postanesthesia care unit, 2 hours after surgery, 4 hours after surgery, 8 hours after surgery, at discharge from hospital, and once daily at day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 after surgery."|within 14 days|||units on a scale*days||Inter-Quartile Range|Median
668631|NCT01722097|Primary|Shoulder Pain|"Number of participants with shoulder pain or discomfort (VAS > 20) in the shoulder region within 14 days after operation.
VAS 0-100: Visual analouge scale for assessment of pain ranging from no pain (value 0) to worst kind of pain (value 100)."|within 14 days|||participants|||Number
668663|NCT01721330|Primary|Change in Adult Investigator Symptom Rating Scale (AISRS) Score|The AISRS is an 18-item clinician rating scale to evaluate individual ADHD symptoms on a scale of 0 (none) to 3 (severe). The total sum ranges from 0 (no ADHD symptoms) to 54 (extremely severe ADHD symptoms). We measured the change in AISRS score from baseline to week 6.|6 weeks|One subject withdrew from the study before receiving study medication, so data from only two subjects was analyzed (one subject in each group). Therefore, means and standard deviations were not calculated.||units on a scale|||Number
668632|NCT01722071|Primary|Functional Magnetic Resonance Imaging (fMRI) Data: Change in BOLD Activity Between Placebo and Oxytocin Treatment.|"Drug effect will be assessed by ascertaining changes in brain activity between placebo and oxytocin sessions.
Imaging data will be analyzed from all subjects in a final analysis. Individual subject analyses will be done on a bimonthly basis.
Results represent neural responses to the anticipation of an uncertain reward within the Nucleus Accumbens (Bilateral). These are given as beta values (i.e. parameter estimates)."|Change from Week 1, Day 1 (Scan 1) and Scan 2 (within the first 30 days after scan 1).|Only 8 participants' BOLD data were included in the final group analysis in the Placebo then Oxytocin arm -- 1 participant was excluded from the study prior to scanning, 1 participant was scanned but due to technical issues the BOLD data was not used.||BOLD signal change (beta values)||Standard Error|Mean
668633|NCT01721967|Secondary|Kansas City Cardiomyopathy Questionnaire (KCCQ)|Kansas City Cardiomyopathy Questionnaire (KCCQ) (scores range from 0 to 100 with higher scores representative of a higher quality of life; clinically important changes are considered > 10 points and >5 points, respectively, as previously established|60 days post treatement|||units on a scale||Standard Deviation|Mean
668634|NCT01721967|Secondary|Seattle Angina Questionnaire (SAQ)|The Seattle Angina Questionnaire (SAQ) is a self-administered, 19-item questionnaire, a cardiac disease-related quality-of-life measure. The SAQ is well validated and sensitive to clinical changes. It has five subscales: physical limitation, angina stability, angina frequency, treatment satisfaction, and disease perception. The possible range of scores for each of the five subscales is 0 to 100, with higher scores indicating better quality of life.|60 Days post treatment|||units on a scale||Standard Deviation|Mean
668635|NCT01721967|Secondary|Improvement in Number of Episodes of Angina Per Week|Efficacy of ranolazine in HCM patients with respect to improvements in angina frequency (number of episodes of angina per week).|Baseline and 60 Days post treatment|episodes of angina per week was not collected|||||
668636|NCT01721967|Primary|Drug Tolerability|Total number of patients that tolerated 1,000mg BID dose and 500 mg BID dose|60 days|||participants|||Number
668637|NCT01721967|Primary|Number of Adverse Events Considered Probably or Possibly Related to Study Drug|Number of events that are considered probably or possibly related to study drug.|60 Days|||adverse event|||Number
668638|NCT01721967|Primary|QT Interval||60 Days|||msec||Standard Deviation|Mean
668639|NCT01721837|Primary|Creatinine Clearance (Recalculated Using Entries of Age, Gender, Body Weight and Serum Creatinine Made by the Physician)|The creatinine clearance was recalculated with the Cockcroft-Gault formula using age, gender, body weight, and serum creatinine.|One single observation time point: at the time of prescription before the first intake of dabigatran etexilate|All patients with documented mild or moderate renal impairment and non-valvular atrial fibrillation (PPS) having evaluable data for age, gender, body weight, and serum creatinine. In 145 patients age, gender, serum creatinine or weight was missing so that Creatinine Clearance according to the Cockcroft Gault formula could not be recalculated.||ml/min||Inter-Quartile Range|Median
668640|NCT01721772|Secondary|Change From Baseline in Health-related Quality of Life (HRQoL) Scores|HRQoL is evaluated by mean changes from baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) global health status/quality of life composite scale in all randomized patients. The QLQ-30 is a cancer-specific, self-administered questionnaire that contains 30 questions, covering global, functional, and symptom scales. Scores range from 0 to 100. Higher scores on global and functional scales indicate better quality of life (QoL), while higher scores on the symptom scales indicate declining QoL.|At baseline and every 6 weeks for 12 months and at follow-up visits 1 and 2, assessed up to 17 months|All participants randomized to receive treatment; n=number of participants evaluable||Units on a scale||Standard Deviation|Mean
668641|NCT01721772|Primary|Overall Survival (OS) Rate|OS rate is calculated as the percentage of participants who have not died divided by the total number of participants in the arm, based on Kaplan-Meier estimates|Randomization to 6 months and 12 months|All participants randomized to receive treatment||Percentage of participants||95% Confidence Interval|Number
668642|NCT01721772|Other Pre-specified|Number of Participants Who Died and With Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs) Leading to Discontinuation, Drug-related AEs Leading to Discontinuation, and Drug-related AEs|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=having certain, probable, possible, or unknown relationship to study drug.|Day of first dose to day of final dose + 30 days, assessed up go 17 months|All participants who received at least 1 dose of study drug||Participants|||Number
668643|NCT01721772|Secondary|Overall Survival by Programmed Cell Death Ligand 1 (PD-L1) Expression Level|Overall Survival by PD-L1 expression level, which was defined as the percent of tumor cells demonstrating plasma membrane PD-L1-staining in a minimum of 100 evaluable tumor cells per a Dako PD-L1 IHC assay (referred to as quantifiable PD-L1 expression). Assessment of OS by PD-L1 expression as measured by a validated assay and comparing OS in patients with tumor PD-L1 expression ≥5% versus patients with tumor PD-L1 expression <5%. Tumor tissue samples for PD-L1 testing were collected at screening from metastatic or unresectable sites prior to randomization.|From date of randomization to date of disease progression or death, as assessed to 17 months|All participants randomized to receive treatment||Months||95% Confidence Interval|Median
668664|NCT01721317|Secondary|Number of Participants With the Indicated Assessment Events of Suicidal Behavior, Suicidal Ideation or Non-suicidal Self Injurious Behavior Via the Columbia Suicide Severity Rating Scale (C-SSRS)|Prospective assessment of suicidality was conducted using the Columbia-Suicide Severity Rating Scale (C-SSRS), a brief questionnaire designed to assess severity and change in suicidality by integrating both behavior and ideation using a semi-structured interview to probe participant responses. C-SSRS data were only collected through Week 8 for the 6 randomized participants. Due to the study being prematurely terminated, there was not sufficient data to evaluate this endpoint.|Week 0 (end of Baseline Phase), Week 2 (end of Titration Phase), Week 4, Week 6 and Week 8|Safety Population||Participants|||Number
668729|NCT01721096|Secondary|Target Vessel Revascularization (TLR or TVR Non-TLR)|Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR non-TLR) or non-ischemia driven TVR (TLR or TVR non-TLR)|1 year post index procedure|||percentage of participants|||Number
668644|NCT01721772|Secondary|Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST)|ORR is defined as the percentage of participants with a best overall response of RECIST-defined complete response (CR) or partial response (PR) divided by the number of randomized participants in each treatment arm. RECIST, volume 1.1 for target lesions: CR=disappearance of all target lesions; PR=at least a 30% decrease in the sum of the longest dimension (LD) of target lesions, taking as reference the baseline sum LD; stable disease=neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started; PD=at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, and the sum LD must have an absolute increase of ≥5 mm.|Tumor assessments beginning at 9 weeks following randomization and continuing every 6 weeks for the first year, then every 12 weeks thereafter until disease progression or death, assessed to 17 months|All participants randomized to receive treatment||Percentage of participants||95% Confidence Interval|Number
668645|NCT01721772|Secondary|Progression-free Survival (PFS) Rate|The PFS rate at a time point is the estimated percentage of patients who have not progressed and are alive at that time point following randomization and is estimated using the Kaplan-Meier methodology.|Tumor assessments beginning at 9 weeks following randomization and continuing every 6 weeks for the first year, then every 12 weeks thereafter until disease progression or death, assessed to 17 months|All participants randomized to receive treatment||Percentage of participants||95% Confidence Interval|Number
668646|NCT01721772|Secondary|Progression-free Survival (PFS)|Investigator-assessed PFS is defined as the time from randomization to the date of the first documented progression, as determined by the investigator, or death due to any cause, whichever occurs first. Patients who died without progressing were considered to have progressed on the date of their death. Those who did not progress or die were censored on the date of their last evaluable tumor assessment. Patients who did not have any on-study tumor assessments and did not die were censored on their date of randomization. Those who started any subsequent anticancer therapy without a prior reported progression were censored on the date of their last evaluable tumor assessment prior to initiation of subsequent anticancer therapy.|From date of randomization to date of disease progression or death, assessed to 17 months|All participants randomized to receive treatment||Months||95% Confidence Interval|Median
668647|NCT01721772|Primary|Overall Survival (OS)|OS is defined as the time between the date of randomization and the date of death. For those without documentation of death, OS will be censored on the last date the participant was known to be alive.|From date of randomization to date of death. For those without documentation of death, to the last date the participant was known to be alive, assessed to 17 months.|All participants randomized to receive treatment||Months||95% Confidence Interval|Median
668657|NCT01721564|Secondary|Intravascular Ultrasound - Pulmonary Artery Wall Thickness|Change in intima-media thickness|baseline and 6 months|||percentage of baseline||Standard Deviation|Mean
668658|NCT01721564|Primary|Acetylcholine Vascular Reactivity Response|Percent pulmonary flow change from baseline after acetylcholine|Baseline and 6 months|||percentage of baseline||Standard Deviation|Mean
668659|NCT01721486|Secondary|Parental Satisfaction With Pain Control.|Parental satisfaction with pain control, as measured on a 10 point Likert scale where 1= Extremely dissatisfied and 10= Extremely satisfied. Data gathered through phone call to parents 24 hours post hospital discharge.|24 hours post hospital discharge.|||units on a scale||Inter-Quartile Range|Median
668660|NCT01721486|Secondary|Incidence of Post-operative Vomiting|Percentage of subjects with at least one episode of post-operative vomiting|From admission into PACU until 24 hours post-hospital discharge. At the conclusion of enrollment, this measure will be assessed for all participants.|||Participants|||Count of Participants
668661|NCT01721486|Secondary|FLACC: Face, Legs, Activity, Cry & Consolability (FLACC) Pain Assessment Scores|FLACC: Face, Legs, Activity, Cry, and Consolability Pain Assessment Scale (FLACC), a five-item, three point scale that measures each of 5 pain behaviors on a scale of 0 - 2 which are summed to result in a total score of 0 - 10. Clinical judgment is used to interpret pain. The higher the score on the FLACC correlates with a higher pain score (0= no behaviors indicative of pain and 10= five behaviors indicative of significant pain). This scale was evaluated by blinded post-operative anesthesia care unit (PACU) Registered Nurses (RNs) at admission to PACU.|At time of admission into PACU.|||units on a scale||Full Range|Median
668665|NCT01721317|Secondary|Change From Baseline in Post-void Residual (PVR) Urinary Bladder Ultrasound Volume|The change from Baseline in the PVR bladder ultrasound results was to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase) and Week 18 (end of Maintenance Phase)|Safety Population|||||
668666|NCT01721317|Secondary|Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick|The change from Baseline in the following urinalysis parameters (urine occult blood, urine glucose, urine ketones and urine protein) were to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population|||||
668667|NCT01721317|Secondary|Change From Baseline in Urine Potential of Hydrogen (pH)|The change from Baseline in the indicated urinalysis test was to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize ot evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population|||||
668668|NCT01721317|Secondary|Change From Baseline in Urine Specific Gravity (USG)|The change from Baseline in the indicated urinalysis test was to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population|||||
668669|NCT01721317|Secondary|Change From Baseline in Creatinine Clearance|The change from Baseline in the indicated chemistry test was to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population|||||
668670|NCT01721317|Secondary|Change From Baseline in BUN/Creatinine Ratio|The change from Baseline in the indicated chemistry tests was to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population|||||
668671|NCT01721317|Secondary|Change From Baseline in Calcium, Chloride, Potassium, Sodium, Glucose, Magnesium, Phosphorus Inorganic, Bicarbonate and Urea/Blood Urea Nitrogen (BUN)|The change from Baseline in the indicated chemistry tests were to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population|||||
668672|NCT01721317|Secondary|Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Uric Acid and Creatinine|The change from Baseline in the indicated chemistry tests were to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population|||||
668673|NCT01721317|Secondary|Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase, Lactate Dehydrogenase and Gamma Glutamyltransferase (GGT)|The change from Baseline in the indicated chemistry tests were to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population|||||
668674|NCT01721317|Secondary|Change From Baseline in Albumin and Total Protein|The change from Baseline in the indicated chemistry tests were to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population|||||
668675|NCT01721317|Secondary|Change From Baseline in Mean Corpuscle Hemoglobin|The change from Baseline in the indicated hematology test was to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population|||||
668676|NCT01721317|Secondary|Change From Baseline in Red Blood Cell (RBC) Count|The change from Baseline in the indicated hematology test was to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population|||||
668677|NCT01721317|Secondary|Change From Baseline in Hematocrit|The change from Baseline in the indicated hematology test was to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population|||||
668678|NCT01721317|Secondary|Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration|The change from Baseline in the indicated hematology tests were to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population|||||
668679|NCT01721317|Secondary|Change From Baseline in the Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Segmented Neutrophils, White Blood Cell (WBC) Count and Platelet Count|The change from Baseline in the indicated hematology tests were to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population|||||
673679|NCT01660672|Other Pre-specified|Number of Subjects With Retinopathy at Enrollment|Retinopathy status may impact LVT efficacy and subject status will be analyzed based on this characteristic.|Upon admission|||participants|||Number
668680|NCT01721317|Secondary|Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Segmented Neutrophils and Red Blood Cell (RBC) Distribution Width|The change from Baseline in the indicated hematology tests were to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population|||||
668681|NCT01721317|Secondary|Change From Baseline in the QT Interval Using Bazett’s Correction (QTcB) and QT Interval Using Fridericia’s Correction (QTcF)|Change from Baseline in the QT interval using Bazett's correction (QTcB) and QT interval using Fridericia's correction were to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 2 (end of Titration Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population|||||
668682|NCT01721317|Secondary|Change From Baseline in Heart Rate|Change from Baseline in heart rate was to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 2 (end of Titration Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population|||||
668683|NCT01721317|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Change from Baseline in blood pressure was to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 2 (end of Titration Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population|||||
668684|NCT01721317|Secondary|Change From Baseline in Body Weight|Change from Baseline in body weight was to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 2 (end of Titration Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population|||||
668685|NCT01721317|Secondary|Number of Participants With Early Study Discontinuation|The safety and tolerability of ezogabine/retigabine IR was to be evaluated by recording the incidence of participants with early study discontinuation.|Week 0 (end of Baseline Phase) to Week 21 (end of Taper Phase)|Safety Population||Participants|||Number
668686|NCT01721317|Secondary|Number of Participants at Each Dose During the Maintenance Phase and Average Maintenance Dose Over All Participants|The safety and tolerability of ezogabine/retigabine IR was to be evaluated by recording the number of participants at each dose during the Maintenance Phase and the average maintenance dose over all participants. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Week 11 (start of Maintenance Phase) to Week 18 (end of Maintenance Phase)|Safety Population|||||
668687|NCT01721317|Secondary|Incidence of New Seizure Types in Participants Without a History of These Seizure Types|The safety and tolerability of ezogabine/retigabine IR was to be evaluated by recording the incidence of new seizure types in participants without a history of these seizure types. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Week 0 (end of Baseline Phase) to Week 21 (end of Taper Phase)|Safety Population: all randomized participants who receive >= 1 dose of study medication.|||||
668688|NCT01721317|Secondary|Percent Change From Baseline in Functional Status (Epilepsy-related Worry and Activity Limitation) and Productivity (Missed Work or School) to the End of the Dose-Optimization Phase and the End of the Maintenance Phase|The effect of ezogabine/retigabine IR as an adjunctive treatment on health outcomes was to be evaluated on the basis of functional status and productivity. Participants were asked to complete the paper functional status diary to collect information to assess how the participant’s functional status is affected by their epilepsy symptoms. Participants were asked to rate their epilepsy-related worry, activity limitations, and productivity (missed work or school). Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Week 3 (start of Dose -Optimization Phase) to Week 18 (end of Maintenance Phase)|ITT Population|||||
668689|NCT01721317|Secondary|Change From Baseline in the Number of Seizure Free Days for the Indicated Intervals: Double-blind Period (Titration Phase + Dose-Optimization Phase + Maintenance Phase), Maintenance Phase and the Dose-Optimization + Maintenance Phase|The change in number of seizure free days during the Double-Blind period, the Maintenance Phase and the Dose-Optimization Phase + Maintenance Phase were to be reported. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Week 0 (end of Baseline Phase) to Week 18 (end of Maintenance Phase)|ITT Population|||||
668690|NCT01721317|Secondary|Number of Seizure Free Participants for the Indicated Intervals: Maintenance Phase and the Dose-Optimization Phase + Maintenance Phase|Participants without seizures during the interval of Maintenance Phase and the Dose-Optimization Phase + Maintenance Phase were to be reported. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Week 3 (start of Dose-Optimization Phase) to Week 18 (end of Maintenance Phase)|ITT Population|||||
668691|NCT01721317|Secondary|Number of Par. Experiencing >=50% Reduction in 28-day Total Partial Seizure Frequency (POS) for the Intervals: Double-blind Period (Titration Phase + Dose-Optimization Phase + Maintenance Phase), Maintenance Phase and Dose-Optimization + Maintenance Phase|Participants (par.) experiencing >= 50% reduction from Baseline to the end of the Double-Blind Phase in 28-day total POS were to be reported. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Week 0 (end of Baseline Phase) through Week 18 (end of Maintenance Phase)|ITT Population|||||
668702|NCT01721161|Secondary|Change in SD-OCT Average RGCL/IPL at Week 24: Per-protocol Population|Adjusted mean change in thicknesses of the RGCL/IPL at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by segmentation of SD-OCT. Adjusted for the baseline RGCL/IPL thickness.|Baseline, Week 24|Per-protocol Population: participants from the ITT population who completed the study, did not miss more than 1 dose of BIIB033 or placebo, and did not receive MS-modifying therapies during the study period, which were prohibited per protocol. LOCF imputation was used if Week 24 data were missing.||µm||Standard Deviation|Mean
668692|NCT01721317|Secondary|Percent Change in 28-day Total Partial Seizure Frequency (POS) for the Indicated Intervals: Maintenance Phase and the Dose-Optimization Phase + Maintenance Phase|The efficacy of ezogabine/retigabine IR as an adjunctive treatment was to be evaluated by the percent change in total partial seizure frequency during the Dose-Optimization Phase and Maintenance Phase. The total 28-day POS value is defined as the total number of POS reported during the evaluation period divided by the total number of applicable days during the evaluation period with this quotient multiplied by 28 days. The applicable days are the days in which the participant had non-missing seizure data (i.e., either 0 or > 0 seizures recorded). Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Week 3 (start of Dose -Optimization Phase) to Week 18 (end of Maintenance Phase)|ITT Population|||||
668693|NCT01721317|Primary|Percent Change in the 28-day Total Partial Seizure Frequency (POS) Within Each Stratum From Week 0 (End of Baseline Phase) Through Week 18 (End of Maintenance Phase)|The percent change in 28-day total POS frequency within each stratum (sodium channel blocker or non-sodium channel blocker) background antiepileptic drug (AED) was to be summarized as the supportive analysis. The total 28-day POS value is defined as the total number of POS reported during the evaluation period divided by the total number of applicable days during the evaluation period with this quotient multiplied by 28 days. The applicable days are the days in which the participant had non-missing seizure data (i.e., either 0 or > 0 seizures recorded). Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Week 0 (end of Baseline Phase) through Week 18 (end of Maintenance Phase)|ITT Population|||||
668694|NCT01721317|Primary|Percent Change in the 28-day Total Partial Seizure Frequency (POS) From Week 0 (End of Baseline Phase) Through Week 18 (End of Maintenance Phase)|The efficacy of ezogabine/retigabine IR as an adjunctive treatment was to be evaluated by the percent change in the total partial seizure frequency, which was recorded by participants in the daily seizure calendar. The total 28-day POS rate is defined as the total number of POS reported during the evaluation period divided by the total number of applicable days during the evaluation period with this quotient multiplied by 28 days. The applicable days are the days in which the participant had non-missing seizure data (i.e., either 0 or > 0 seizures recorded). Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Week 0 (end of Baseline Phase) through Week 18 (end of Maintenance Phase)|Intent-to-Treat (ITT) Population: all randomized participants who received >= 1 dose of study medication and who had >= 1 post-Baseline seizure diary day with >= 0 seizures recorded.|||||
668695|NCT01721226|Secondary|Linkage to Community Care|At least 1 visit to health care provider in past 24 weeks/6 months|24 weeks|||Participants|||Count of Participants
668696|NCT01721226|Primary|Plasma Viral Load Suppression|Plasma viral load at 24 weeks measured by viral load testing or medical chart abstraction|24 weeks|All study participants with available PVL data||participants|||Number
668697|NCT01721161|Secondary|Summary of BIIB033 Concentration|One pre-dose pharmacokinetic (PK) sample and 1 post-dose PK sample (approximately between 1 and 3 hours after the end of IV infusion) were collected for all participants on Day 1 and at Weeks 4 through 20 (every 4 weeks). Additionally, only 1 PK sample was collected at Week 24 and Week 32. (There was no dosing on Week 24 and Week 32, so only one blood sample for BIIB033 concentration was taken.) Samples collected at early termination visits were treated as predose samples for the next scheduled visit.|Up to 32 weeks|PK analysis population: all participants who received at least 1 dose of BIIB033 and had at least 1 serum concentration data on record. n=number of participants with a sample at given timepoint.||µg/mL||Full Range|Median
668698|NCT01721161|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence that did not necessarily have a causal relationship with this treatment. An SAE was any untoward medical occurrence that at any dose: resulted in death; in the view of the Investigators, placed the subject at immediate risk of death (a life-threatening event); however, this did not include an event that, had it occurred in a more severe form, might have caused death; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigators, could have jeopardized the subject or may have required intervention to prevent one of the other outcomes listed in the definition above.|32 weeks|Safety population: all participants who received at least 1 dose of study treatment.||participants|||Number
668699|NCT01721161|Primary|Change in FF-VEP Latency at Week 24: Per-protocol Population|Adjusted mean change in optic nerve conduction velocity (NCV) at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by FF-VEP. Adjusted for the baseline latency of fellow eye.|Baseline, Week 24|Per-protocol Population: participants from the ITT population who completed the study, did not miss more than 1 dose of BIIB033 or placebo, and did not receive multiple sclerosis (MS)-modifying therapies during the study period, which were prohibited per protocol. LOCF imputation was used if Week 24 data were missing.||msec||Standard Error|Mean
668700|NCT01721161|Secondary|Change in LCLA at Week 24: Per-protocol Population|Adjusted mean change in LCLA at Week 24 from baseline as determined by 1.25% and 2.5% low contrast Sloan letter charts, adjusted for the baseline LCLA value. The fellow eye is the reference eye for the inter-eye asymmetry. The range for LCLA assessment is 0-60.|Baseline, Week 24|Per-protocol Population: participants from the ITT population who completed the study, did not miss more than 1 dose of BIIB033 or placebo, and did not receive MS-modifying therapies during the study period, which were prohibited per protocol. LOCF imputation was used if Week 24 data were missing.||letters on a chart||Standard Error|Mean
668701|NCT01721161|Secondary|Change in Low-contrast Letter Acuity (LCLA) at Week 24: ITT Population|Adjusted mean change in LCLA at Week 24 from baseline as determined by 1.25% and 2.5% low contrast Sloan letter charts, adjusted for the baseline LCLA value. The fellow eye is the reference eye for the inter-eye asymmetry. The range for LCLA assessment is 0-60.|Baseline, Week 24|ITT population: all randomized subjects who received at least 1 dose of study treatment (BIIB033 or placebo) with an LCLA assessment at Baseline. LOCF imputation was used if Week 24 data were missing.||letters on a chart||Standard Deviation|Mean
668721|NCT01721096|Secondary|Percent Diameter Stenosis (%DS)|The value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.|Post procedure|||percentage of DS|Participants|Standard Deviation|Mean
673680|NCT01660672|Other Pre-specified|Number of Participants With Neurologic Sequelae at Discharge|Number of participants with neurologic sequelae at discharge|day 7|||participants|||Number
668703|NCT01721161|Secondary|Change in SD-OCT Average Retinal Ganglion Cell Layer/Inner Plexiform Retinal Layer (RGCL/IPL) at Week 24: ITT Population|Adjusted mean change in thicknesses of the RGCL/IPL at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by segmentation of SD-OCT. Adjusted for the baseline RGCL/IPL thickness.|Baseline, Week 24|ITT population: all randomized subjects who received at least 1 dose of study treatment (BIIB033 or placebo) with a valid RGCL/IPL assessment at Baseline. LOCF imputation was used if Week 24 data were missing.||µm||Standard Deviation|Mean
668704|NCT01721161|Secondary|Percentage Change in SD-OCT Average RNFL Thickness at Week 24: Per-protocol Population|Adjusted mean percentage change in thickness of the RNFL at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by SD-OCT. Percentage change is calculated as (affected eye - baseline of fellow eye)/baseline of fellow eye*100. Adjusted for the baseline RNFL thickness.|Baseline, Week 24|Per-protocol Population: participants from the ITT population who completed the study, did not miss more than 1 dose of BIIB033 or placebo, and did not receive MS-modifying therapies during the study period, which were prohibited per protocol. LOCF imputation was used if Week 24 data were missing.||percentage change||Standard Error|Mean
668705|NCT01721161|Secondary|Percentage Change in Spectral-domain Optical Coherence Tomography (SD-OCT) Average Retinal Nerve Fiber Layer (RNFL) Thickness at Week 24: ITT Population|Adjusted mean percentage change in thickness of the RNFL at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by SD-OCT. Percentage change is calculated as (affected eye - baseline of fellow eye)/baseline of fellow eye*100. Adjusted for the baseline RNFL thickness.|Baseline, Week 24|ITT population: all randomized subjects who received at least 1 dose of study treatment (BIIB033 or placebo) and a valid RNFL assessment at Baseline. LOCF imputation was used if Week 24 data were missing.||percentage change||Standard Error|Mean
668706|NCT01721161|Primary|Change in Full-field Visual Evoked Potential (FF-VEP) Latency at Week 24: Intent-to-treat (ITT) Population|Adjusted mean change in optic nerve conduction velocity (NCV) at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by FF-VEP. Adjusted for the baseline latency of fellow eye.|Baseline, Week 24|ITT population: all randomized subjects who received at least 1 dose of study treatment (BIIB033 or placebo). Last observation carried forward (LOCF) imputation was used if Week 24 data were missing.||msec||Standard Error|Mean
668707|NCT01721109|Secondary|Change From Baseline in CD4 Percentage at Weeks 24 and 48||Baseline; Weeks 24 and 48|Participants in the Full Analysis Set with available data were analyzed.||percentage||Standard Deviation|Mean
668708|NCT01721109|Secondary|Change From Baseline in CD4+ Cell Count at Weeks 24 and 48||Baseline; Weeks 24 and 48|Participants in the Full Analysis Set with available data were analyzed.||cells/µL||Standard Deviation|Mean
668709|NCT01721109|Secondary|Change From Baseline in Plasma log10 HIV-1 RNA at Weeks 24 and 48||Baseline; Weeks 24 and 48|Full Analysis Set: all participants who were enrolled in the study and received at least 1 dose of study drug.||log10 copies/mL||Standard Deviation|Mean
668710|NCT01721109|Secondary|For Part B, Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Weeks 24 and 48 as Defined by the FDA Snapshot Analysis||Weeks 24 and 48|Full Analysis Set: all participants who were enrolled in the study and received at least 1 dose of study drug.||percentage of participants|||Number
668711|NCT01721109|Secondary|For Part B, Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 24 and 48 as Defined by the FDA Snapshot Analysis||Weeks 24 and 48|Full Analysis Set: all participants who were enrolled in the study and received at least 1 dose of study drug.||percentage of participants|||Number
668712|NCT01721109|Secondary|For Part A, PK Parameter: AUCtau of FTC, TFV, and COBI|AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).|Predose, 2, 4, 4.5, 5, 8, and 12 hours postdose on Day 10|PK Analysis Set: all enrolled and treated participants from Part A who had at least 1 observed trough/single concentration data of the respective analyte.||ng•h/mL||Standard Deviation|Mean
668713|NCT01721109|Secondary|For Part A, PK Parameter: Cmax of EVG, FTC, TFV, and COBI|Cmax is defined as the maximum concentration of drug.|Predose, 2, 4, 4.5, 5, 8, and 12 hours postdose on Day 10|PK Analysis Set: all enrolled and treated participants from Part A who had at least 1 observed trough/single concentration data of the respective analyte.||ng/mL||Standard Deviation|Mean
668714|NCT01721109|Secondary|For Part A, PK Parameter: Ctau of EVG, FTC, Tenofovir (TFV), and COBI|Ctau is defined as the observed drug concentration at the end of the dosing interval.|Predose, 2, 4, 4.5, 5, 8, and 12 hours postdose on Day 10|PK Analysis Set: all enrolled and treated participants from Part A who had at least 1 observed trough/single concentration data of the respective analyte.||ng/mL||Standard Deviation|Mean
668715|NCT01721109|Primary|For Part B, Incidence of Treatment-Emergent Serious Adverse Events (SAEs) and All Treatment-Emergent Adverse Events (AEs)||Up to Week 48 plus 30 days|Safety Analysis Set: all participants who received at least 1 dose of study drug.||Participants|||Count of Participants
668716|NCT01721109|Primary|For Part A, Pharmacokinetic (PK) Parameter: AUCtau of EVG|AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).|Predose, 2, 4, 4.5, 5, 8, and 12 hours postdose on Day 10|PK Analysis Set: all enrolled and treated participants from Part A who had at least 1 observed trough/single concentration data of the respective analyte.||ng•h/mL||Standard Deviation|Mean
668717|NCT01721096|Secondary|Net Gain: In-stent, In-segment|Late procedural outcome is influenced by both the acute gain provided by the intervention (pre to post) and the subsequent late loss that occurs after the intervention (post to follow-up).The net gain is thus the sum of the offsetting effects of acute gain and late loss (net gain = acute gain – late loss).|8 months post index procedure|||mm|Participants|Standard Deviation|Mean
668718|NCT01721096|Secondary|Late Loss(LL): In-stent, In-segment, Proximal, and Distal|Late loss is calculated as MLD post procedure – MLD at follow-up.|8 months post index procedure|||mm|Participants|Standard Deviation|Mean
668719|NCT01721096|Secondary|Acute Gain: In-stent, In-segment|The difference between post- and pre-procedural MLD.|8 months post index procedure|||mm|Participants|Standard Deviation|Mean
668720|NCT01721096|Secondary|Percent Diameter Stenosis (%DS)|The value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.|8 months post index procedure|Number of participants analyzed includes the number available for QCA.||percentage of DS|Participants|Standard Deviation|Mean
678168|NCT01600482|Secondary|Time to Discharge-ability|Time to discharge-ability|30 days +/- 7 days|107 did not have time to dischargeability data collected.||Minutes||Standard Deviation|Mean
668733|NCT01721096|Secondary|Target Lesion Revascularization|"Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR.
Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion."|1 year post index procedure|||percentage of participants|||Number
668734|NCT01721096|Secondary|Target Lesion Revascularization|"Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR.
Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion."|8 months post index procedure|||percentage of participants|||Number
668735|NCT01721096|Secondary|Myocardial Infarction|The endpoint myocardial infarction includes ST-elevation MI, non ST-elevation MI, Q wave MI and non Q wave MI|1 year post index procedure|||percentage of participants|||Number
668736|NCT01721096|Secondary|Myocardial Infarction|The endpoint myocardial infarction includes ST-elevation MI, non ST-elevation MI, Q wave MI and non Q wave MI|8 months post index procedure|||percentage of participants|||Number
668737|NCT01721096|Secondary|Death|Death includes cardiac death, non-cardiac death and non-coronary death.|1 year post index procedure|||percentage of participants|||Number
668738|NCT01721096|Secondary|Death|Death includes cardiac death, non-cardiac death and non-coronary death.|8 months post index procedure|||percentage of participants|||Number
668739|NCT01721096|Secondary|Composite Endpoint of Cardiac Death or Target Vessel MI||1 year post index procedure|||percentage of participants|||Number
668740|NCT01721096|Secondary|Composite Endpoint of Cardiac Death or Target Vessel MI||8 months post index procedure|||percentage of participants|||Number
668741|NCT01721096|Secondary|Composite Endpoint of Cardiac Death or MI||1 year post index procedure|||percentage of participants|||Number
668742|NCT01721096|Secondary|Composite Endpoint of Cardiac Death or MI||8 months post index procedure|||percentage of participants|||Number
668743|NCT01721096|Secondary|Composite Endpoint of Death or MI||1 year post index procedure|||percentage of participants|||Number
668744|NCT01721096|Secondary|Composite Endpoint of Death or MI||8 months post index procedure|||percentage of participants|||Number
668745|NCT01721096|Secondary|Composite Endpoint of Cardiac Death/All MI/CI-TLR (MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial-infarction, and clinically-indicated target lesion revascularization (CI-TLR).|1 year post index procedure|||percentage of participants|||Number
668746|NCT01721096|Secondary|Composite Endpoint of Cardiac Death/All MI/CI-TLR (MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial-infarction, and clinically-indicated target lesion revascularization (CI-TLR).|8 months post index procedure|||percentage of participants|||Number
668747|NCT01721096|Secondary|Composite Endpoint of Target Vessel Failure|Target vessel failure includes cardiac death, MI and ischemia driven TLR; ischemia driven TVR, non TLR; ischemia driven TVR (TLR or TVR, non-TLR).|1 year post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.||percentage of participants|||Number
668748|NCT01721096|Secondary|Composite Endpoint of Target Vessel Failure|Target vessel failure includes cardiac death, MI and ischemia driven TLR; ischemia driven TVR, non TLR; ischemia driven TVR (TLR or TVR, non-TLR).|8 months post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.||percentage of participants|||Number
668749|NCT01721096|Secondary|Composite Endpoint of All Death/All MI/All Revascularization (DMR)||1 year post index procedure|||percentage of participants|||Number
668750|NCT01721096|Secondary|Composite Endpoint of All Death/All MI/All Revascularization (DMR)||8 months post index procedure|||percentage of participants|||Number
668751|NCT01721096|Secondary|Composite Endpoint of Target Lesion Failure|Target lesion failure includes cardiac death, Target vessel MI and ischemia driven TLR|1 year post index procedure|||percentage of participants|||Number
668752|NCT01721096|Secondary|Composite Endpoint of Target Lesion Failure|Target lesion failure includes cardiac death, Target vessel MI and ischemia driven TLR|8 months post index procedure|||percentage of participants|||Number
668753|NCT01721096|Secondary|Success Rate: Implant Success by Patient||Participants will be followed for the duration of hospital stay, an average of 5 days|The number of participants analyzed excludes subjects who were lost-to-follow-up.||percentage of participants||95% Confidence Interval|Number
668754|NCT01721096|Secondary|Success Rate: Procedural Success by Lesion||Participants will be followed for the duration of hospital stay, an average of 5 days|The number of participants analyzed excludes subjects who were lost-to-follow-up.||percentage of participants|Participants|95% Confidence Interval|Number
668755|NCT01721096|Secondary|Success Rate: Implant Success Rate by Device||Participants will be followed for the duration of hospital stay, an average of 5 days|The number of participants analyzed excludes subjects who were lost-to-follow-up.||percentage of participants|Participants|95% Confidence Interval|Number
668756|NCT01721096|Primary|Overall Stent Thrombosis|Stent thrombosis was defined by ARC criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation), or very late (>1 year post stent implantation).|1 year post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.||percentage of participants|||Number
668812|NCT01719861|Secondary|Median Serum Desipramine Levels During Treatment|"Median serum desipramine levels during treatment is reported as the median of the maximum steady state serum concentration observed in all patients.
Therapeutic concentration of desipramine is 100 to 300 ng/mL, and toxic concentration is > 300 ng/mL."|Up to 6 weeks|All patients who were enrolled and started therapy.||ng/mL||Full Range|Median
668757|NCT01721096|Primary|Late Stent Thrombosis (ST)|Stent thrombosis was defined by ARC criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation), or very late (>1 year post stent implantation).|Late (>30 days to 1 year)|The number of participants analyzed excludes subjects who were lost-to-follow-up.||percentage of participants|||Number
668758|NCT01721096|Primary|Subacute Stent Thrombosis (ST)|Stent thrombosis was defined by ARC criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation), or very late (>1 year post stent implantation).|Subacute (>24 hours to 30 days)|The number of participants analyzed excludes subjects who were lost-to-follow-up.||percentage of participants|||Number
668759|NCT01721096|Primary|Acute Stent Thrombosis (ST)|Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).|Time Frame: Acute (0-24 hours)|The number of participants analyzed excludes subjects who were lost-to-follow-up.||percentage of participants|||Number
668760|NCT01721070|Primary|Cmax|Maximum plasma concentration; After each dosing of Sufentanil NanoTab, serial blood samples will be taken at regular time points.|0 (pre-dose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes, and 24 hours after dosing.|2 of the 19 subjects had incomplete PK data and were excluded from PK analysis (1 due to early withdrawal and 1 due to AE)||pg/mL||Standard Deviation|Mean
668761|NCT01721070|Primary|AUC (0-inf)|Total amount of sufentanil absorbed; After each dosing of Sufentanil NanoTab, serial blood samples will be taken at regular time points.|0 (pre-dose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes, and 24 hours after dosing.24 hours|2 of the 19 subjects had incomplete PK data and were excluded from PK analysis (1 due to early withdrawal and 1 due to AE)||h*pg/mL||Geometric Coefficient of Variation|Geometric Mean
668762|NCT01721057|Secondary|Population PK: Maximum Concentration at Steady State of Dosing (AUC,ss) of LY3009104||Week 0: 30 and 90 minutes postdose; Week 8: 1 hour postdose; Week 12, Week 20 and Week 24; predose|All randomized participants who received at least 1 dose of study drug with evaluable PK data.||nanograms per mL per hour (ng/mL*h)||Geometric Coefficient of Variation|Geometric Mean
668763|NCT01721057|Secondary|Population Pharmacokinetics (PK): Maximum Concentration at Steady State of Dosing (Cmax,ss) of LY3009104||Week 0: 30 and 90 minutes postdose; Week 8: 1 hour postdose; Week 12, Week 20 and Week 24:predose|All randomized participants who received at least 1 dose of study drug with evaluable PK data.||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
668764|NCT01721057|Secondary|Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Scores|The Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) questionnaire was developed to measure the effect of general health and symptom severity on work productivity and regular activities in the 7 days prior to the visit. It contains 6 items covering overall work productivity (health), overall work productivity (symptom), impairment of regular activities (health), and impairment of regular activities (symptom). Scores are calculated as impairment percentages. The WPAI-RA yields four types of scores: Absenteeism (work time missed), Presenteeism (impairment at work), Work productivity loss (overall work impairment), and Activity impairment.|Baseline, Week 12; Baseline, Week 24|mITT population: all randomized participants who received at least 1 dose of the study drug. Change from baseline includes participants with a baseline value and an observed value at the time point being summarized.||percentage of impairment||Standard Deviation|Mean
668765|NCT01721057|Secondary|Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores (Self-Perceived Health)|A second component of the EQ-5D-5L is a self-perceived health score which is assessed using a VAS that ranges from 0 to 100 millimeter (mm), where 0 indicates the worst health you can imagine and 100 indicates the best health you can imagine.|Baseline Week 12; Baseline Week 24|mITT population: all randomized participants who received at least 1 dose of the study drug , with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.||mm||Standard Deviation|Mean
668813|NCT01719861|Secondary|Desipramine Maximum Dose|Assessed as the median per patient maximum dose (MD) using intra-patient dose escalation, and reported as the highest dose of desipramine administered continuously for 1 week or greater.|Up to 6 weeks|All patients who were enrolled and started therapy.||mg daily||Full Range|Median
669846|NCT01708057|Primary|Change From Baseline in Trough FEV1 (22-26h)|The average over 22 to 26 hours, as change from baseline|22 to 26 hours following dose administration|As the study was terminated prematurely none of the randomized patients have been analysed.|||||
668766|NCT01721057|Secondary|Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores|European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. One component consists of a descriptive system of the respondent's health comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1. A higher score indicates better health state.|Baseline Week 12; Baseline Week 24|mITT population: all randomized participants who received at least 1 dose of the study drug , with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.||units on a scale||Standard Deviation|Mean
668767|NCT01721057|Secondary|Change From Baseline in Mental Component Score (MCS), Physical Component Score (PCS) of the Medical Outcomes Study 36-Item Short Form Health Survey Version 2 Acute (SF-36v2 Acute)|The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (mental [MCS] and physical [PCS]). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status or functioning.|Baseline, Week 12; Baseline, Week 24|mITT population: all randomized participants who received at least 1 dose of the study drug , with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.||units on a scale||Standard Deviation|Mean
668768|NCT01721057|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores.|"The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale is a brief 13-item, symptom-specific questionnaire that specifically assesses the participant's self-reported severity of fatigue and its impact upon daily activities and functioning. The FACIT-F uses a numeric rating scale of 0 (Not at all) to 4 (Very much) for each item to assess fatigue and its impact in the past 7 days. Total scores range from 0 to 52, with higher scores indicating less fatigue."|Baseline, Week 12; Baseline Week 24|mITT population: all randomized participants who received at least 1 dose of the study drug , with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.||units on a scale||Standard Deviation|Mean
668769|NCT01721057|Secondary|Percentage of Participants Achieving American College of Rheumatology European League Against Rheumatism (ACR/EULAR) Remission – Boolean Remission|The ACR/EULAR definitions of RA remission includes a Boolean-based definition. The Boolean-based definition of remission occurs when all 4 of the following criteria are met at the same visit: TJC28 ≤1, SJC28 ≤1, acute phase response using C-reactive protein (milligrams per deciliter) ≤1, Patient's Global Assessment of Disease Activity using VAS (cm) ≤1.|Week 12|mITT population: all randomized participants who received at least 1 dose of the study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.||percentage of participants|||Number
668770|NCT01721057|Secondary|Change From Baseline in DAS28-Erythrocyte Sedimentation Rate (DAS28-ESR)|DAS28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), Erythrocyte Sedimentation Rate (ESR) (millimeters per hour), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-ESR=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.70*natural log(ESR)+0.014*Patient's Global VAS. Scores ranged 1.0-9.4, where lower scores indicated less disease activity.|Baseline, Week 12|mITT population: all randomized participants who received at least 1 dose of the study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.||units on a scale||Standard Deviation|Mean
668771|NCT01721057|Secondary|Change From Baseline in Measures of Simplified Disease Activity Index (SDAI) Score|The SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Patient's Global Assessment of Disease Activity using visual analog scale (cm), and Physician's Global Assessment of Disease Activity using visual analog scale (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity.|Baseline, Week 24|mITT population: all randomized participants who received at least 1 dose of the study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.||units on a scale||Standard Deviation|Mean
668772|NCT01721057|Secondary|Change From Baseline in Measures of Clinical Disease Activity Index (CDAI) Score|The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28, SJC28, Patient's Global Assessment of Disease Activity using visual analog scale (cm), and Physician's Global Assessment of Disease Activity using visual analog scale (cm). The CDAI is calculated by summing the values of the 4 components. Lower scores indicated less disease activity.|Baseline, Week 24|mITT population: all randomized participants who received at least 1 dose of the study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using modified last observation carried forward (mLOCF) .||units on a scale||Standard Deviation|Mean
668773|NCT01721057|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response|ACR70 Responder Index is composite of clinical, laboratory, and functional measures in RA. “ACR70 Responder” is a participant who has at least 70% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, HAQ-DI, pain due to arthritis, and hsCRP. Participants with missing responses and participants who discontinue study or drug or are rescued before analysis timepoint are deemed non-responders.|Week 12, Week 24|mITT population: all randomized participants who received at least 1 dose of the study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.||percentage of participants|||Number
668774|NCT01721057|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response|"ACR50 Responder Index is composite of clinical, laboratory, and functional measures in RA. “ACR50 Responder” is a participant who has at least 50% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria:
Physician Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, HAQ-DI, pain due to arthritis, and hsCRP. Participants with missing responses and participants who discontinue study or drug or are rescued before analysis timepoint are deemed non-responders."|Week 12, Week 24|mITT population: all randomized participants who received at least 1 dose of the study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.||percentage of participants|||Number
668775|NCT01721057|Secondary|Mean Worst Joint Pain Numeric Rating Scale (NRS) in the Prior 7 Days as Collected in Electronic Diaries|"Participants rated their joint pain by selecting a number from 0 to 10 that best described their worst joint pain during the last 24 hours, where 0 represents no pain and 10 represents pain as bad as you can imagine. Participants reported their worst joint pain in daily electronic diaries. The average value across the 7 days preceding each visit is calculated. A decrease in joint pain severity rating indicated an improvement in the participant's condition."|Week 12|mITT population: all randomized participants who received at least 1 dose of the study drug and had at least 4 entries within any post-baseline 7-day window are included in the analysis.||units on a scale||Standard Deviation|Mean
668776|NCT01721057|Secondary|Mean Worst Tiredness Numeric Rating Scale (NRS) in the Prior 7 Days as Collected in Electronic Diaries|"Participants rated their tiredness by selecting a number from 0 to 10 that best described their level of worst tiredness during the past 24 hours, where 0 represents no tiredness and 10 represents as bad as you can imagine. Participants reported their worst tiredness in daily electronic diaries. The average value across the 7 days preceding each visit is calculated. A decrease in tiredness severity rating indicated an improvement in the participant's condition."|Week 12|mITT population: all randomized participants who received at least 1 dose of the study drug and had at least 4 entries within any post-baseline 7-day window are included in the analysis.||units on a scale||Standard Deviation|Mean
668777|NCT01721057|Secondary|Mean Severity of Morning Joint Stiffness Numeric Rating Scale (NRS) in the Prior 7 Days as Collected in Electronic Diaries|"Participants rated the severity of their MJS by selecting a number from 0 to 10 that best described their overall level of MJS from the time they woke up, where 0 represents no joint stiffness and 10 represents joint stiffness as bad as you can imagine. Participants reported their severity daily in electronic diaries. The average value across the 7 days preceding each visit is calculated. A decrease in severity rating indicated an improvement in the participant's condition."|Week 12|mITT population: all randomized participants who received at least 1 dose of the study drug and had at least 4 entries within any post-baseline 7-day window are included in the analysis.||units on a scale||Standard Deviation|Mean
668778|NCT01721057|Secondary|Mean Duration of Morning Joint Stiffness(MJS) in the Prior 7 Days as Collected in Electronic Daily Diaries|Participants reported the duration of their morning joint stiffness (MJS) in hours and minutes into daily electronic diaries. If MJS duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. The average value across the 7 days preceding each visit is calculated. A decrease in duration of MJS indicated an improvement in the participant's condition.|Week 12|mITT population: all randomized participants who received at least 1 dose of the study drug and had at least 4 entries within any post-baseline 7-day window are included in the analysis.||minutes||95% Confidence Interval|Median
668779|NCT01721057|Secondary|Percentage of Participants Achieving Simplified Disease Activity Index (SDAI) ≤3.3|SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Participant's Global Assessment of Disease Activity using VAS centimeters (cm), and Physician's Global Assessment of Disease Activity using VAS (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity. An index-based definition of remission occurs with an SDAI score ≤3.3.|Week 12|mITT population: all randomized participants who received at least 1 dose of the study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.||percentage of participants|||Number
668780|NCT01721057|Secondary|Change From Baseline in the Disease Activity Score Based on a 28-Joint Count and High-sensitivity C-reactive Protein (DAS28-hsCRP)|Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), C-reactive protein (CRP) (milligrams per liter), and Patient's Global Assessment of Disease Activity using visual analog scale (VAS) (participant global VAS). DAS28 was calculated using following formula: DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*Patient's Global VAS+0.96. Scores ranged 1.0-9.4, where lower scores indicated less disease activity.|Baseline, Week 12|mITT population: all randomized participants who received at least 1 dose of the study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mBOCF.||units on a scale||Standard Deviation|Mean
668781|NCT01721057|Secondary|Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score|The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty (0 [without any difficulty], 1 [with some difficulty], 2 [with much difficulty], and 3 [unable to do])when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate the HAQ-DI score, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.|Baseline, Week 12|mITT population: all randomized participants who received at least 1 dose of the study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using modified baseline observation carried forward (mBOCF).||units on a scale||Standard Deviation|Mean
668814|NCT01719861|Primary|Overall Response Rate (ORR)|Overall response rate (ORR) was assessed as the number of patients who achieve either a partial (PR) or complete response (CR) measured by CT scans and Response Evaluation Criteria In Solid Tumors (RECIST 1.1) criteria, divided by the total number of patients treated on the study. CR: Disappearance of all target lesions, all non-target lesions, and no new lesion. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesion.|6 weeks|All patients who were enrolled and started therapy.||percentage of participants|||Number
668782|NCT01721057|Primary|Percentage of Participants Achieving American College of Rheumatology 20% Improvement (ACR20)|"ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). ACR20 Responder is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity using visual analog scale (VAS), Health Assessment Questionnaire - Disability Index (HAQ-DI), pain due to arthritis, and high-sensitivity C-reactive protein (hsCRP). Participants with missing responses and participants who discontinue study or drug or are rescued before analysis timepoint are deemed non-responders."|Week 12|Modified Intent-to-Treat (mITT) population: all randomized participants who received at least 1 dose of the study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using non-responder imputation (NRI).||percentage of participants|||Number
668783|NCT01720797|Primary|Tooth Movement Between the Groups|"Accelerated tooth movement effectiveness as measured by dental impressions. These impressions at the 6 month follow-up will evaluate the rate of tooth movement by measuring casts.
Ortholnsight software was used to measure the millimeters of tooth movement from the dental impressions, and then was converted to a Mean and Standard Deviation measurement."|6 months|||percentage of movement||Standard Deviation|Mean
668784|NCT01720602|Secondary|Overall Survival|Kaplan-Meier survival curves will be used to describe overall survival.|Up to 5 years||||||
668785|NCT01720602|Secondary|Progression-free Survival (PFS)|Kaplan-Meier survival curves will be used to describe PFS.|Up to 5 years||||||
668786|NCT01720602|Secondary|Duration of Response|Duration of response will be summarized for responders.|Up to 5 years|||weeks||Full Range|Median
668787|NCT01720602|Primary|Response Rate According to RECIST|"A 90% score (Wilson) confidence interval will be computed for the response rate.
Clinical benefit according to Recist score is defined as: Stable Disease, Partial Remission or Complete Remission. Lack of clinical benefit is defined as Progressive Disease (increase in target lesion size by 20% or more)."|8 weeks|||percentage of patients||90% Confidence Interval|Number
668788|NCT01720602|Primary|Rate of Clinical Benefit of Patients Receiving Vorinostat/AI Combination Therapy According to RECIST|"A 90% score (Wilson) confidence interval will be computed for the rate of clinical benefit.
Clinical benefit according to Recist score is defined as: Stable Disease, Partial Remission or Complete Remission. Lack of clinical benefit is defined as Progressive Disease (increase in target lesion size by 20% or more)."|8 weeks|||percentage of patients||90% Confidence Interval|Number
668789|NCT01720316|Secondary|Auditory Evoked Potentials - P50 Ratio (P50 S2/P50 S1 Amplitude) at 1) BASELINE - Pre-glycine Treatment and 2) IN WEEK 6 OF GLYCINE TREATMENT|Auditory evoked potentials amplitude: P50 ratio (S2/S1). Participants were assessed at baseline and in week 6 of open-label glycine treatment.|Recordings at baseline and week 6 of glycine|Only one subject received these procedures because normal hearing is required.||ratio|||Number
668790|NCT01720316|Secondary|Auditory Evoked Potentials in Gammas Oscillations (the Power Spectrum is Measured in Microvolts Squared) at 1) BASELINE - Pre-glycine Treatment and 2) IN WEEK 6 OF GLYCINE TREATMENT|Auditory evoked potentials gamma: G40 hz phase locking at fz and cz; G20 hz phase locking response at fz and cz G30 hz phase locking response at fz and cz. Participants were assessed at baseline and in week 6 of open-label glycine treatment.|Recordings at baseline and week 6 of glycine|Only one subject received these procedures because normal hearing is required.||microvolts squared|||Number
668791|NCT01720316|Secondary|Auditory Evoked Potentials in Amplitude (Degrees Measured in Microvolts) at 1) BASELINE - Pre-glycine Treatment and 2) IN WEEK 6 OF GLYCINE TREATMENT|Auditory evoked potentials amplitude: P300 at fz, cz, and pz; N100 at fz and cz; P200 at fz and cz; P50 S1 and S2 amplitude; mismatch negativity (MMN) at fz and cz. Participants were assessed at baseline and in week 6 of open-label glycine treatment.|Recordings at baseline and week 6 of glycine|Only one subject received these procedures because normal hearing is required.||microvolts|||Number
668792|NCT01720316|Secondary|Change in Magnocellular Pathway Function on Glycine Compared With Baseline. No Data Were Collected.|functional magnetic resonance imaging|6 weeks per treatment arm|Data not collected.|||||
668793|NCT01720316|Secondary|Auditory Evoked Potentials in Latency (Msec) at BASELINE - Pre-glycine Treatment and 2) IN WEEK 6 OF TREATMENT WITH GLYCINE|Auditory evoked potentials latency: P300 at fz, cz, and pz); N100 at fz and cz); P200 at fz and cz. Participants were assessed at baseline and in week of open-label glycine treatment.|Recordings at baseline and week 6 of glycine|Only one subject received these procedures because normal hearing is required.||msec|||Number
668794|NCT01720316|Secondary|Brain GABA Metabolite Levels (GABA/Creatine Ratio: GABA/Cr) at 1) BASELINE - Pre-glycine Treatment and 2) IN WEEK 6 OF GLYCINE TREATMENT|Magnetic resonance spectroscopy GABA/Cr. Participants were assessed 1) pre-glycine treatment (baseline) and 2) in week 6 of open-label glycine treatment measured in posterior occipital cortex.|Baseline and week 6 of glycine|||ratio|||Number
668795|NCT01720316|Secondary|Brain Glutamate Metabolite Levels (Glutamate/Creatine Ratio: Glu/Cr) at 1) BASELINE - Pre-glycine Treatment and 2) IN WEEK 6 OF GLYCINE TREATMENT|magnetic resonance spectroscopy - glutamate metabolite level. Participants were assessed 1) pre-glycine treatment and in week 6 of open-label glycine treatment. Measured in posterior occipital cortex.|baseline and week 6 of glycine|||ratio|||Number
668796|NCT01720316|Secondary|Brain Glycine/CR Ratio|magnetic resonance spectroscopy: glycine/creatine ratio. Participants were assessed at 1) BASELINE PRE-GLYCINE TREATMENT: pre-glycine challenge drink, 60 minutes post challenge drink, 80 minutes post challenge drink, 100 minutes post challenge drink, and 120 minutes post challenge drink (0.4 g/kg up to max of 30 g); and 2) IN WEEK 6 OF OPEN-LABEL GLYCINE TREATMENT: pre-glycine dose, and 60 minutes, 80 minutes, 100 minutes and 120 minutes post daily dose of glycine. Measured in posterior occipital cortex|baseline (pre-challenge, 60, 80, 100, 120 minutes post-challenge), and week 6 of glycine (pre-dose and 60, 80, 100, 120 minutes post-dose|||ratio|||Number
668815|NCT01719757|Secondary|Overall Satisfaction Assessment About Efficacy and Tolerability of Oxycodone/Naloxone by the Investigator and Subject|The overall satisfactions by investigators & subjects were assessed 5 steps such as Very good, Good, Satisfactory, Bad, Very bad.|4 weeks|Intent to treat analysis set(Last observational carried forward)||participants|||Number
668816|NCT01719757|Secondary|Change of Constipation Assessment From Baseline to Visit 2(End Visit)|Constipation assessment(5-point scale; 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe, for the patient's judgment of the intensity of symptoms)|4 weeks|Intent to treat analysis set(Last observational carried forward)||score||Standard Deviation|Mean
668797|NCT01720316|Primary|Depression Symptom Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period|Hamilton Depression Scale measures severity of depression symptoms. The sum of ratings for 9 depression symptoms are measured on a scale from 0-2 with 0 meaning no symptoms and 2 meaning some level of severity of that specific symptom. The rating for 1 depression symptom is measured on a scale from 0-3 with 0 meaning no symptoms and 3 meaning a severe level of that specific symptom. The sum of ratings for 11 depression symptoms are measured on a scale from 0-4 with 0 meaning no symptoms and 4 meaning a severe level of that specific symptom. The three sums are added to produce an overall depression rating scale score ranging from 0-65.|baseline and at 2 weeks, 4 weeks, and 6 weeks within each treatment period|||units on a scale|||Number
668798|NCT01720316|Primary|Mania Symptom Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period|Young Mania Rating Scale (YMRS) measures severity of manic symptoms. The sum of ratings for 7 symptoms of mania is measured on a scale from 0-4 and the sum of 4 symptoms of mania is measured on a scale from 0-8 to yield a total score ranging from 0-60, with 0 meaning no manic symptoms and 60 meaning severe manic symptoms.|baseline and at 2 weeks, 4 weeks, and 6 weeks within each treatment period|||units on a scale|||Number
668799|NCT01720316|Primary|Clinical Global Impression (CGI) Therapeutic Effect Scores at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period|Clinical Global Impression (CGI) therapeutic effect scores measure degree of improvement as marked (1), moderate (5), minimal (9) or unchanged/worse (13).|at 2 weeks, 4 weeks, and 6 weeks within each treatment period|||score|||Number
668800|NCT01720316|Primary|Clinical Global Impression (CGI) Severity Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period|Clinical Global Impression (CGI) severity scores measure severity of mental illness on a scale of 1-7 where 1 means normal, not at all ill, 2 means borderline mentally ill, 3 means mildly ill, 4 means moderately ill, 5 means markedly ill, 6 means severely ill and 7 means among the most extremely ill patients.|CGI at baseline and at 2 weeks, 4 weeks, and 6 weeks per treatment period|||units on a scale|||Number
668801|NCT01720316|Primary|Brief Psychiatric Rating Scale (BPRS) Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks Positive and Negative Symptom Scores at Baseline and at 2, 4, and 6 Weeks During Intervention 1, Intervention 2, and During Open-label Glycine|Total BPRS score measures severity of 18 psychiatric symptoms. Each symptom is scored 1-7 with the total score ranging from 18-126. 18 means no symptoms and 126 means very severe symptoms.|baseline and at 2 weeks, 4 weeks, and 6 weeks within and after each treatment period|||units on a scale|||Number
668802|NCT01720316|Primary|Glycine Plasma Amino Acid Levels at Baseline, During Glycine Treatment, During Placebo Treatment and During Open-label Glycine|Plasma glycine levels; normal range is 122-467 nM/mL|At baseline, during glycine treatment, during placebo treatment and during open-label glycine|||nM/mL|||Number
668803|NCT01720316|Primary|Neurocognitive Function at Baseline, During Glycine Treatment, During Placebo Treatment and During Open-label Glycine|Scores on each of 8 domains of cognitive function (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning/problem solving, social cognition, overall composite). Scores are T scores ranging from 0-100, with 50 representing the mean for a population based on a normal distribution; standard deviation of 10. Only overall composite score is entered.|At baseline, during glycine treatment, during placebo treatment and during open-label glycine|Data provided for each participant separately.||units on a scale|||Number
668804|NCT01720316|Primary|Positive and Negative Symptom Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks During Intervention 1 (Glycine or Placebo), Intervention 2 (Glycine or Placebo), and During Open-label Glycine|Positive and Negative Symptom Scale (PANSS) measures positive and negative symptoms of schizophrenia. The sum of ratings for seven positive symptoms are measured on a scale from 7-49 with 7 meaning no symptoms and 49 meaning severe symptoms.|baseline and at 2 weeks, 4 weeks, and 6 weeks within each treatment period and after each treatment period|||units on a scale|||Number
668805|NCT01720251|Other Pre-specified|Immunological Markers: Specific IgE and IgG4|blood samples will be drawn at the above time points to measure immunological markers: specific IgE and IgG4|before treatment, 4 weeks after the last injection and 2 weeks before, at the peak time and within 2 weeks after the end of the expected birch pollen season 2013||||||
668806|NCT01720251|Secondary|Safety and Tolerability|Adverse events will be collected throughout the trial period and will be reported as Treatment emergent adverse events occurring between start of treatment and 28 days after completion of treatment for each subject|from start of treatment to 28 days after completion of treatment, i.e. for approximately 12 weeks||||||
668807|NCT01720251|Secondary|Quality of Life|mini-RQLQ questionnaires|up to 6 weeks during the birch pollen season 2013||||||
668808|NCT01720251|Primary|Combined Rhinoconjunctivitis Symptom and Medication Score|"The efficacy analysis will be performed on the symptom and medication data collected from the first day of the birch pollen season as defined by pollen counts in the air in each site region (from March to May 2013 depending on site region), to 42 days later or to the end of the pollen season, whichever comes first.
The scale range is from 0 to 3. Lower is the the RSMS value, better is the efficacy as this implies that lower is the symptoms and concomitant medication intake by the patient The RSMS includes 2 subscales : the Rhinoconjunctivitis Symptom Score (RSS) with a range of values from 0 to 3 and the Rhinoconjunctivitis Medication Score Score (RMS) with also a range of values from 0 to 3 The RSMS is the sum of the RSS and RMS divided by 2"|up to 6 weeks during the birch pollen season 2013|||score (maximum=3)||Standard Deviation|Mean
668809|NCT01720043|Primary|Efficacy of Velcade|Effect of VELCADE at 1.0-1.3 mg/m2 dose on platelet aggregation at 24 and 48 hour post-infusion in patients with multiple myeloma. The following components of platelet aggregation were evaluated at varying levels: Collagen, Adenine di-Phosphate (ADP), Arachidonic acid, and Ristocetin.|48 hours|One patient withdrew before receiving the 24 hour dose, leaving 7 patients evaluable for response.||percentage||Standard Deviation|Mean
668810|NCT01719861|Secondary|Median Overall Survival (OS)|Median overall survival was defined as time from enrollment to death from any cause calculated using the Kaplan-Meier method.|From start of enrollment until death, no limit|All patients who were enrolled and started therapy.||Months||Full Range|Median
668811|NCT01719861|Secondary|Progression-free Survival (PFS), Median|Median PFS was defined as the time from randomization to disease progression (or death if the patient died before progression) calculated using the Kaplan-Meier method.|Up to 5 years from enrollment to radiographic progression or drug discontinuation|All patients who were enrolled and started therapy.||Months||Full Range|Median
668817|NCT01719757|Secondary|Change of Eastern Cooperative Oncology Group(ECOG) Performance Status|"If ECOG P.S score is increased from baseline to visit2, the results mean that QOL was worse.
ECOG P.S grade: 0=Fully active, able to carry on all pre-disease performance without restriction, 1=Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work,2=Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours,3=Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours,4=Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair,5=Death."|4weeks|Intent to treat analysis set: 304||Score||Standard Deviation|Mean
668818|NCT01719757|Primary|Change in Numeric Rating Scales (NRS) Score|Primary objective: Change in numeric rating scales (NRS) such as score for average pain levels over the previous 24 hours, from baseline (visit 1) to study end (visit 2). NRS score was measured from 0 (No pain) to 10(worst pain imaginable).|4 weeks|Intent to treat analysis set: 304||units on a scale||Standard Deviation|Mean
668819|NCT01719653|Secondary|Adequate/Inadequate Scale|The cleanliness of the colon as rated by the gastroenterologist using an adequate/inadequate scale where an adequate preparation is defined as being able to see at least 95% of the mucosa of the colon after washing and suctioning; otherwise, the preparation is rated as inadequate.|At completion of colonoscopy - day 1|||Participants|||Count of Participants
668820|NCT01719653|Secondary|Boston Bowel Preparation Scale|The quality of the colon preparation as graded using Boston Bowel Preparation total scores is range from 0 (very poor) to 9 (outstanding).|At completion of colonoscopy - day 1|||units on a scale||Standard Deviation|Mean
668821|NCT01719653|Primary|Chicago Bowel Preparation Scale|The quality of the colon preparation as graded using our new Chicago Bowel Preparation Scale (BPS) (Adventist Midwest Region Institutional Review Board, AMH 2010-01-80; ClinicalTrials.gov NCT01063049). Chicago BPS total score is ranges from 0 (very poor) to 36 (outstanding). Modified Chicago BPS total score is ranges from 0 (very poor) to 33 (outstanding). Chicago BPS Fluid score is ranges from 0 (dry) to 3 (wet).|At completion of colonoscopy - day 1|||units on a scale||Standard Deviation|Mean
668822|NCT01719172|Secondary|Median Time to Achieve Hemostasis|Hemostasis will be assessed every 30 seconds until the 5-minute time point, at which point the visual inspection will continue at one-minute intervals up to 10 minutes or until hemostasis is achieved.|Intra-operative (Day 0)|||Minutes||95% Confidence Interval|Median
668823|NCT01719172|Secondary|Proportion of Subjects Who Achieve Hemostasis Within 1 Minute|Hemostasis will be assessed every 30 seconds until the 5-minute time point, at which point the visual inspection will continue at one-minute intervals up to 10 minutes or until hemostasis is achieved.|Intra-operative (Day 0)|||participants|||Number
668824|NCT01719172|Primary|Percent Success in Obtaining Hemostasis Following Veriset Hemostatic Patch Treatment|Success will be defined as hemostasis obtained within 5 minutes. Hemostasis will be assessed every 30 seconds until the 5-minute time point, at which point the visual inspection will continue at one-minute intervals up to 10 minutes or until hemostasis is achieved.|Intra-operative (Day 0)|||participants|||Number
668825|NCT01719003|Secondary|Body Weight Change From Baseline at Week 24|"Change from baseline in body weight (kg) after 24 weeks of treatment.
“Baseline” refers to the last observation before the start of any randomised trial treatment. medication. Means presented are the adjusted means."|baseline and 24 weeks|FAS observed cases (OC) (Only patients with available data are analysed)||kg||Standard Error|Mean
668826|NCT01719003|Secondary|FPG (Fasting Plasma Glucose) Change From Baseline at Week 24|"Change from baseline in FPG (mg/dL) after 24 weeks of treatment.
“Baseline” refers to the last observation before the start of any randomised trial treatment medication. Means presented are the adjusted means."|baseline and 24 weeks|FAS observed cases (OC) (Only patients with available data are analysed)||mg/dL||Standard Error|Mean
668827|NCT01719003|Primary|HbA1c (Glycosylated Haemoglobin) Change From Baseline at Week 24|"Change from baseline in HbA1c (%) after 24 weeks of treatment.
“Baseline” refers to the last observation before the start of any randomised trial treatment medication. Means presented are the adjusted means"|baseline and 24 weeks|FAS observed cases (OC) (Only patients with available data are analysed)||percentage of HbA1c||Standard Error|Mean
668828|NCT01718691|Secondary|Laboratory Test Abnormalities (Hematology Tests)|Abnormalities in laboratory test values in overall study period were analyzed. Severity of abnormalities were evaluated using CTCAE. Grade 1 : mild Grade 2 : moderate Grade 3 : severe or medically significant but not immediately life-threatening Grade 4 : life threatening or disabling Grade 5 : death related to AE|up to 30 weeks|||participants|||Number
668829|NCT01718691|Secondary|Laboratory Test Abnormalities (Biochemical Tests)|Abnormalities in laboratory test values in overall study period were analyzed. Severity of abnormalities were evaluated using CTCAE. Grade 1 : mild Grade 2 : moderate Grade 3 : severe or medically significant but not immediately life-threatening Grade 4 : life threatening or disabling Grade 5 : death related to AE|up to 30 weeks|||participants|||Number
668830|NCT01718691|Secondary|Number of Subjects With Adverse Event, Related Adverse Event, Serious Adverse Event, and Discontinuation Due to Adverse Event|Adverse events were evaluated using Common Terminology Criteria for Adverse Events (CTCAE) v4.0, Japan Clinical Oncology Group/Japan Society of Clinical Oncology (JCOG/JSCO) version, and were encoded using Medical Dictionary for Regulatory Activities (MedDRA) Ver.16.1.|up to 30 weeks|||participants|||Number
668831|NCT01718691|Secondary|Overall Survival (OS)|Death due to any given cause was defined as an event. OS was calculated using the Kaplan-Meier estimator. The median and the 95% CI were calculated using Greenwood’s formula.|Up to 30 weeks|||days||95% Confidence Interval|Median
668832|NCT01718691|Secondary|Duration of Response (DOR)|"DOR is the period from the date of achieving CR, CRu or PR in the responders to the earliest onset date of any progression events calculated using the Kaplan-Meier estimator. The median and the 95% CI were calculated using Greenwood’s formula.
The date of achieving CR, CRu or PR was determined based on the overall response assessed using IWRC. The date of progression was determined based on overall response assessed using IWRC, Revised RC and WHO, and assessment by the primary physicians (excluding overall response).
Progression event was defined as progression (includes recurrence/relapse), initiation of post-study treatment, confirmation of other malignant tumor, or death due to any given cause."|Up to 30 weeks|||days||95% Confidence Interval|Median
669847|NCT01708057|Primary|Change From Baseline in Peak FEV1 (0-24h)|The maximum value over 24 hours post-dose, as change from baseline|The first 24 hours following dose administration|As the study was terminated prematurely none of the randomised patients have been analysed.|||||
668833|NCT01718691|Secondary|Progression-Free Survival (PFS)|"PFS is the period from registration date to the earliest onset date of any progression event calculated using the Kaplan-Meier estimator. The median and the 95% confidence interval (CI) were calculated using Greenwood’s formula.
Progression event was defined as progression (includes recurrence/relapse), initiation of post-study treatment, confirmation of other malignant tumor, or death due to any given cause. The date of progression was determined based on overall response assessed using IWRC, Revised RC, and WHO, and assessment by the primary physicians (excluding overall response)."|Up to 30 weeks|||days||95% Confidence Interval|Median
668834|NCT01718691|Secondary|"Overall Response Rate (PR or Better) Based on WHO Handbook for Reporting Results of Cancer Treatment (1979)"|"The criteria for Overall response rate (PR or better) based on WHO Handbook for Reporting Results of Cancer Treatment (1979) are shown below.
Definition of PR:
Measurable disease:
50% or more decrease in total tumor size of the lesions which have been measured to determine the effect of therapy by 2 observations not less than 4 weeks apart. In addition there can be no appearance of new lesions or progression of any lesion.
Unmeasurable disease:
Estimated decrease in tumor size of 50% or more for at least 4 weeks.
Bone metastases:
Partial decrease in size of lytic lesions, recalcification of lytic lesions, or decreased density of blastic lesions for at least 4 weeks."|Up to 30 weeks|||percentage of participants|||Number
668835|NCT01718691|Secondary|Complete Response Rate Based on WHO Handbook for Reporting Results of Cancer Treatment (1979)|"The criteria for Complete response based on WHO Handbook for Reporting Results of Cancer Treatment (1979) are shown below.
Measurable disease:
The disappearance of all known disease, determined by 2 observations not less than 4 weeks apart.
Unmeasurable disease:
Complete disappearance of all known disease for at least 4 weeks.
Bone metastases:
Complete disappearance of all lesions on X-ray or scan for at least 4 weeks."|Up to 30 weeks|||percentage of participants|||Number
668836|NCT01718691|Secondary|Overall Response Rate (PR or Better) Based on Revised Response Criteria for Malignant Lymphoma (2007)(Revised RC)|"The criteria for PR based on the Revised RC are shown below.
Definition: Regression of measurable disease and no new sites
Nodal Masses:
50% or more decrease in SPD of up to 6 largest dominant masses; no increase in size of other nodes
FDG-avid or PET positive prior to therapy; one or more PET positive at previously involved site
Variably FDG-avid or PET negative; regression on CT
Spleen, Liver:
50% or more decrease in SPD of nodules (for single nodule in greatest transverse diameter); no increase in size of liver or spleen
Bone Marrow:
Irrelevant if positive prior to therapy; cell type should be specified."|Up to 30 weeks|||percentage of participants|||Number
668837|NCT01718691|Secondary|Complete Response Rate (CR) Based on Revised Response Criteria for Malignant Lymphoma (2007)(Revised RC)|"The criteria for CR based on the Revised RC are shown below.
Definition: Disappearance of all evidence of disease
Nodal Masses:
[18F]fluorodeoxyglucose (FDG)-avid or PET positive prior to therapy; mass of any size permitted if PET negative.
Variably FDG-avid or PET negative; regression to normal size on CT.
Spleen, Liver:
Not palpable, nodules disappeared
Bone Marrow:
Infiltrate cleared on repeat biopsy; if indeterminate by morphology, immunohistochemistry should be negative."|Up to 30 weeks|||percentage of participants|||Number
668838|NCT01718691|Secondary|Overall Response Rate (Antitumor Effect: PR or Better) Based on International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas (1999)(IWRC)|"The criteria for PR based on IWRC are shown below.
PR: SPD regressed > 50%"|Up to 30 weeks|||percentage of participants|||Number
668839|NCT01718691|Primary|Complete Response Rate (CR + CRu) Based on International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas (1999)(IWRC)|"The criteria for CR and CRu based on IWRC are shown below.
CR: Fulfills all of the following
Disappearance of all detectable disease
LN* > 1.5 cm must decrease to ≤ 1.5 cm
CRu: Fulfills all of the following
LN >1.5 cm; SPD** decrease >75%
indeterminate bone marrow
LN: lymph nodes or nodal masses ** SPD: sum of the products of the greatest diameters"|Up to 30 weeks|||percentage of participants|||Number
668840|NCT01718535|Primary|Percent Agreement|The study will pass if the percent agreement is ≥ 99.0% and the lower bound of a 1-sided 95% confidence interval is ≥ 95.0% using the score method.|After second pass result is complete (~3hours)|||Percent Agreement||95% Confidence Interval|Number
668841|NCT01718509|Secondary|Amphetamine Cessation Symptom Assessment (ACSA) Total Score|ACSA scale has 16 symptom items rated on a scale from 0 (not at all) to 4 (extremely) with a possible total score range of 0 to 64. Higher scores indicate greater withdrawal symptom severity.|Up to 12 weeks|Safety Analysis Set||units on a scale||Standard Deviation|Mean
668842|NCT01718509|Secondary|Columbia-Suicide Severity Rating Scale (C-SSRS)|C-SSRS is a semi-structured interview that captures the occurence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale.|Up to 12 weeks|Safety Analysis Set defined as all randomized subjects who took at least 1 dose of investigational product and who had at least 1 post-baseline safety assessment completed. All subjects from Site 015 were excluded from the Safety Analysis Set.||participants|||Number
668843|NCT01718509|Secondary|EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Anxiety/Depression||Up to 12 weeks|Full Analysis Set. Not all subjects had data for this outcome.||percentage of participants|||Number
668844|NCT01718509|Secondary|EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Pain/Discomfort||Up to 12 weeks|Full Analysis Set. Not all subjects had data for this outcome.||percentage of participants|||Number
668845|NCT01718509|Secondary|EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Usual Activities||Up to 12 weeks|Full Analysis Set. Not all subjects had data for this outcome.||percentage of participants|||Number
668846|NCT01718509|Secondary|EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Self-Care||Up to 12 weeks|Full Analysis Set. Not all subjects had data for this outcome.||percentage of participants|||Number
668847|NCT01718509|Secondary|EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Mobility|Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.|Up to 12 weeks|Full Analysis Set. Not all subjects had data for this outcome.||percentage of participants|||Number
668848|NCT01718509|Secondary|Change From Baseline in Frontal Systems Behavior (FrSBe) Total Score at Up to 12 Weeks|The FrSBe is a 46-item self-rating scale designed to measure the neurobehavioral traits associated with the 3 primary regions of the prefrontal cortex. Subjects were asked to indicate the frequency with which they have engaged in certain behaviors using a rating scale from “1” (almost never) to “5” (almost always). Summary scores were calculated and converted to t-score. A decrease from baseline in FrSBe total score represents improvement.|Baseline and up to 12 weeks|Full Analysis Set. Not all subjects had data for this outcome.||t-scores||Standard Error|Least Squares Mean
668849|NCT01718509|Secondary|Change From Baseline in Binge Eating Scale (BES) Score at Week 12|The BES is a self-reported questionnaire containing 16 items designed to assess behavioral, affective, and attitudinal components of the subjective experience of binge eating. Each item is assessed based on 1 of 4 responses, with 1 denoting that a subject has greater control over eating behavior and 4 denoting that a subject had less control over eating behavior. A total score (sum of the 16 items) may range from 16-64. A lower score indicates greater control over eating behavior.|Baseline and week 12|Full Analysis Set.||units on a scale||Standard Error|Least Squares Mean
668850|NCT01718509|Secondary|Change From Baseline in Eating Inventory Scores at Week 12|There are 36 true/false items, 14 items on a 4-point Likert scale (1=eat rarely to 4=always), and 1 item on a 6-point Likert scale (1=eat whatever you want to 6=constantly limiting food intake). Cognitive Restraint score ranges from 0-21. Hunger score ranges from 0-14. Disinhibition score ranges from 0-16. Higher scores denote higher levels of restrained eating, disinhibited eating and predisposition to hunger.|Baseline and week 12|Full Analysis Set.||units on a scale||Standard Error|Least Squares Mean
668851|NCT01718509|Secondary|Change From Baseline in the Number of Binge Episodes Per Week at Visit 8 Which Spans Weeks 11/12||Baseline and Visit 8 Which Spans Weeks 11/12|Full Analysis Set.||Binge episodes per week||Standard Error|Least Squares Mean
668852|NCT01718509|Secondary|Binge Eating Response|"Response is based on the reduction in the number of binge eating episodes. Responses were categorized as follows:
1-week Cessation = 100% reduction in binge episodes during the preceding 7 days
Marked Reduction = 99% to 75% reduction during the time since the previous visit
Moderate Reduction = 74% to 50% reduction during the time since the previous visit
Negative to Minimal Reduction = <50% reduction during the time since the previous visit"|Up to 12 weeks|Full Analysis Set. Not all subjects had data for this outcome.||percentage of participants|||Number
668853|NCT01718509|Secondary|Change From Baseline in Hemoglobin A1c Levels at Up to 12 Weeks||Baseline and up to 12 weeks|Full Analysis Set. Not all subjects had data for this outcome.||Percent||Standard Error|Least Squares Mean
668854|NCT01718509|Secondary|Change From Baseline In Fasting Total Cholesterol Levels at Up to 12 Weeks||Baseline and up to 12 weeks|Full Analysis Set. Not all subjects had data for this outcome.||mmol/L||Standard Error|Least Squares Mean
668855|NCT01718509|Secondary|Change From Baseline in Fasting Triglyceride Levels at Up to 12 Weeks||Baseline and up to 12 weeks|Full Analysis Set. Not all subjects had data for this outcome.||mmol/L||Standard Error|Least Squares Mean
668856|NCT01718509|Secondary|Change From Baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) Total Score at Week 12|The Y-BOCS-BE measures the obsession of binge-eating thoughts and compulsiveness of binge-eating behaviors. The scale is a clinician-rated, 10-item scale, each item rated from 0 (no symptoms) to 4 (extreme symptoms). Total scores range from 0 to 40. Reduction in total score indicates improvement.|Baseline and week 12|Full Analysis Set.||units on a scale||Standard Error|Least Squares Mean
668857|NCT01718509|Secondary|Percent Change From Baseline in Body Weight (kg) at Week 12||Baseline and week 12|Full Analysis Set.||percentage change||Standard Error|Least Squares Mean
668858|NCT01718509|Secondary|Percent of Participants With a 4-Week Cessation From Binge Eating|4-week cessation from binge eating is defined as no binge eating episodes for 28 consecutive days prior to the last study visit.|Up to 12 weeks|Full Analysis Set||percentage of participants||95% Confidence Interval|Number
668859|NCT01718509|Secondary|Percent of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|Up to 12 weeks|Full Analysis Set||percentage of participants||95% Confidence Interval|Number
668860|NCT01718509|Primary|Change From Baseline in the Number of Binge Days Per Week at Visit 8 Which Spans Weeks 11/12|Binge days defined as days during which at least 1 binge episode occurred. As assessed by clinical interview based on subject binge diary.|Baseline and Visit 8 Which Spans Weeks 11/12|The Full Analysis Set was defined as all randomized subjects who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (i.e., number of binge days per week calculated for at least 1 week).||Binge days per week||Standard Error|Least Squares Mean
668861|NCT01718483|Secondary|Amphetamine Cessation Symptom Assessment (ACSA) Total Score|ACSA scale has 16 symptom items rated on a scale from 0 (not at all) to 4 (extremely) with a possible total score range of 0 to 64. Higher scores indicate greater withdrawal symptom severity.|Up to 12 weeks|The Safety Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had at least 1 post-baseline safety assessment completed. Not all participants had data for this outcome.||units on a scale||Standard Deviation|Mean
668862|NCT01718483|Secondary|Columbia-Suicide Severity Rating Scale (C-SSRS)|C-SSRS is a semi-structured interview that captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale. Number of participants with suicidal ideation and suicidal behavior were reported.|Up to 12 weeks|The Safety Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had at least 1 post-baseline safety assessment completed. Not all participants had data for this outcome.||participants|||Number
668898|NCT01717989|Secondary|Percentage of Participants Treated by Each Dialysis Modality|The percentage of participants treated with peritoneal, hemodialysis (in center) or home hemodialysis over the course of the study. For participants who switched modalities within a quarter, the last current modality is reported.|Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.|Primary Analysis Set participants on study at each time point||percentage of participants|||Number
668863|NCT01718483|Secondary|EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Anxiety/Depression|Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Percentage of participants with various anxiety/depression conditions were reported.|Up to 12 weeks|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.||percentage of participants|||Number
668864|NCT01718483|Secondary|EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Pain/Discomfort|Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Percentage of participants with various pain/discomfort conditions were reported.|Up to 12 weeks|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.||percentage of participants|||Number
668865|NCT01718483|Secondary|EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Usual Activities|Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Percentage of participants with various usual activities conditions were reported.|Up to 12 weeks|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.||percentage of participants|||Number
668866|NCT01718483|Secondary|EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Self-Care|Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Percentage of participants with various self-care conditions were reported.|Up to 12 weeks|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.||percentage of participants|||Number
668867|NCT01718483|Secondary|EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Mobility|Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Percentage of participants with various mobility conditions were reported.|Up to 12 weeks|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.||percentage of participants|||Number
668868|NCT01718483|Secondary|Change From Baseline in Frontal Systems Behavior (FrSBe) Total Score at Week 12|The FrSBe is a 46-item self-rating scale designed to measure the neurobehavioral traits associated with the 3 primary regions of the prefrontal cortex. Participants were asked to indicate the frequency with which they have engaged in certain behaviors using a rating scale from “1” (almost never) to “5” (almost always). Summary scores were calculated and converted to t-score. A decrease from baseline in FrSBe total score represents improvement.|Baseline and Week 12|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.||t-scores||Standard Error|Least Squares Mean
668869|NCT01718483|Secondary|Change From Baseline in Binge Eating Scale (BES) Score at Week 12|The BES is a self-reported questionnaire containing 16 items designed to assess behavioral, affective, and attitudinal components of the subjective experience of binge eating. Each item is assessed based on 1 of 4 responses, with 1 denoting that a participant has greater control over eating behavior and 4 denoting that a participant had less control over eating behavior. A total score (sum of the 16 items) may range from 16-64. A lower score indicates greater control over eating behavior.|Baseline and Week 12|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.||units on a scale||Standard Error|Least Squares Mean
668870|NCT01718483|Secondary|Change From Baseline in Eating Inventory Scores at Week 12|"The Eating Inventory also known as the Three-Factor Eating Questionnaire is a 51-item self-reported questionnaire intended to assess 3 dimensions of eating behavior. There are 36 true/false items, 14 items on a 4-point Likert scale (1=eat rarely to 4=always), and 1 item on a 6-point Likert scale (1=eat whatever you want to 6=constantly limiting food intake).
Cognitive Restraint score ranges from 0-21. Hunger score ranges from 0-14. Disinhibition score ranges from 0-16. Higher scores denote higher levels of restrained eating, disinhibited eating and predisposition to hunger."|Baseline and Week 12|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.||units on a scale||Standard Error|Least Squares Mean
668871|NCT01718483|Secondary|Change From Baseline in the Number of Binge Episodes Per Week at Visit 8 (Weeks 11-12)||Baseline and Visit 8 (Weeks 11-12)|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week).||Binge episodes per week||Standard Error|Least Squares Mean
673891|NCT01656967|Secondary|Number of Participants With Overall Intubation Success|Ease of ETT insertion is subjectively assessed by the operator on a scale from 1 to 5 (1 = extremely easy, 5 = extremely difficult).|At ETT insertion|||participant|||Number
668872|NCT01718483|Secondary|Binge Eating Response|"Response is based on the reduction in the number of binge eating episodes. Percentage of participants with response was reported. Responses were categorized as follows:
1-week Cessation = 100% reduction in binge episodes during the preceding 7 days.
Marked Reduction = 99% to 75% reduction during the time since the previous visit.
Moderate Reduction = 74% to 50% reduction during the time since the previous visit.
Negative to Minimal Reduction = <50% reduction during the time since the previous visit."|Week 12/ET|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.||percentage of participants|||Number
668873|NCT01718483|Secondary|Change From Baseline in Hemoglobin A1c Levels at Up to 12 Weeks||Baseline and Week 12/ET|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.||Percent hemoglobin||Standard Error|Least Squares Mean
668874|NCT01718483|Secondary|Change From Baseline In Fasting Total Cholesterol Levels at Up to 12 Weeks||Baseline and Week 12/ET|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.||mmol/L||Standard Error|Least Squares Mean
668875|NCT01718483|Secondary|Change From Baseline in Fasting Triglyceride Levels at Up to 12 Weeks||Baseline and Week 12/Early termination (ET)|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.||millimole per liter (mmol/L)||Standard Error|Least Squares Mean
668876|NCT01718483|Secondary|Change From Baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) Total Score at Week 12|The Y-BOCS-BE measures the obsession of binge-eating thoughts and compulsiveness of binge-eating behaviors. The scale is a clinician-rated, 10-item scale, each item rated from 0 (no symptoms) to 4 (extreme symptoms). Total scores range from 0 to 40. Reduction in total score indicates improvement.|Baseline and Week 12|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.||units on a scale||Standard Error|Least Squares Mean
668877|NCT01718483|Secondary|Percent Change From Baseline in Body Weight at Week 12||Baseline and Week 12|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week).||percent change||Standard Error|Least Squares Mean
668878|NCT01718483|Secondary|Percentage of Participants With a 4-Week Cessation From Binge Eating|4-week cessation from binge eating is defined as no binge eating episodes for 28 consecutive days prior to the last study visit.|Up to 12 weeks|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week).||percentage of participants||95% Confidence Interval|Number
668879|NCT01718483|Secondary|Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores|CGI-I consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|Up to 12 weeks|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week).||percentage of participants||95% Confidence Interval|Number
668880|NCT01718483|Primary|Change From Baseline in the Number of Binge Days Per Week at Visit 8 (Weeks 11-12)|Binge days defined as days during which at least 1 binge episode occurred. As assessed by clinical interview based on participant binge diary.|Baseline and Visit 8 (Weeks 11-12)|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week).||Binge days per week||Standard Error|Least Squares Mean
668881|NCT01718028|Secondary|Percent Change From Baseline in NITFBUT by Visit|NITFBUT is defined as the time elapsed between eye opening after a blink and the appearance of the first break in the tear film, ie, dry area. NITFBUT was evaluated noninvasively with a Tearscope. One eye from each participant was chosen as the study eye, and only data for the study eye contributed to the analysis. The percentage of participants with a lengthening in tear film break up time relative to baseline is reported. A positive value indicates an improvement in film stability, which may improve dry eye symptoms in dry eye sufferers.|Baseline (Day 0), Day 14, Day 30|Intent-to-treat: All randomized participants who received test product and attended at least one on-therapy study visit||percent change||Standard Deviation|Mean
668882|NCT01718028|Secondary|Mean NITFBUT by Visit|NITFBUT is defined as the time elapsed between eye opening after a blink and the appearance of the first break in the tear film, ie, dry area. NITFBUT was evaluated noninvasively with a Tearscope. One eye from each participant was chosen as the study eye, and only data for the study eye contributed to the analysis. A longer tear film break-up time indicates a more stable tear film, which may improve dry eye symptoms in dry eye sufferers.|Baseline (Day 0), Day 14, Day 30|Intent-to-treat: All randomized participants who received test product and attended at least one on-therapy study visit||seconds||Standard Deviation|Mean
668883|NCT01718028|Secondary|Mean Change From Baseline in NITFBUT at Day 14|NITFBUT is defined as the time elapsed between eye opening after a blink and the appearance of the first break in the tear film, ie, dry area. NITFBUT was evaluated noninvasively with a Tearscope. One eye from each participant was chosen as the study eye, and only data for the study eye contributed to the analysis. A positive change value indicates an improvement in tear film stability, which may improve dry eye symptoms in dry eye sufferers.|Baseline (Day 0), Day 14|Intent-to-treat: All randomized participants who received test product and attended at least one on-therapy study visit||seconds||Standard Deviation|Mean
679154|NCT01587079|Secondary|Peak Change From Baseline in Inspiratory Capacity on Day 1|Peak change from baseline in Inspiratory Capacity|Day 1|MITT||Milliliters||95% Confidence Interval|Least Squares Mean
668884|NCT01718028|Primary|Mean Change From Baseline in NITFBUT at Day 30|NITFBUT is defined as the time elapsed between eye opening after a blink and the appearance of the first break in the tear film, ie, dry area. NITFBUT was evaluated noninvasively with a Tearscope. One eye from each participant was chosen as the study eye, and only data for the study eye contributed to the analysis. A positive change value indicates an improvement in tear film stability, which may improve dry eye symptoms in dry eye sufferers.|Baseline (Day 0), Day 30|Intent-to-treat: All randomized participants who received test product and attended at least one on-therapy study visit||seconds||Standard Deviation|Mean
668885|NCT01717989|Secondary|Number of Participants With Transfusions, Hospitalizations, Mortality, and Transfers Out||June to December 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.|Primary Analysis Set participants on study at each time point||participants|||Number
668886|NCT01717989|Secondary|Number of Participants Taking Epoetin Alfa by Month|The number of participants who took epoetin alfa only, by month, in participants on hemodialysis.|December 2010, March 2011, June 2011, September 2011, December 2011|Primary Analysis Set participants on study and on hemodialysis at each time point.||participants|||Number
668887|NCT01717989|Secondary|Cumulative Monthly Dose of Epoetin Alfa Administered|The cumulative monthly intravenous epoetin alfa dose in participants on hemodialysis.|December 2010, March 2011, June 2011, September 2011, December 2011|Primary Analysis Set participants on study and on hemodialysis and receiving epoetin alfa at each time point and with available data.||units||Inter-Quartile Range|Median
668888|NCT01717989|Secondary|Percentage of Participants Per Facility With Transferrin Saturation < 20% and Ferritin Level < 100 ng/mL|The mean percentage of participants per facility with transferrin saturation < 20% and ferritin level < 100 ng/mL. Mean and CI are calculated across facilities and by using number of participants with non-missing transferrin saturation and ferritin in each facility as weight.|December 2010, March 2011, June 2011, September 2011, December 2011|Facilities / participants with at least one non-missing transferrin saturation or ferritin record at each time point.||percentage of participants per facility|Participants|95% Confidence Interval|Mean
668889|NCT01717989|Secondary|Distribution of Facilities With Percentage of Participants With Hemoglobin < 10 g/dL Over Time|Facilities were categorized over time based on the percentage of participants at the facility with hemoglobin < 10 g/dL: Faciities with 0 to <5% of participants with hemoglobin < 10 g/dL; Facilities with 5 to < 10% of participants with hemoglobin < 10 g/dL; Facilities with 10 to < 15% participants with hemoglobin < 10 g/dL; Facilities with 15 to < 20% of participants with hemoglobin < 10 g/dL; Facilities with ≥ 20% of participants with hemoglobin < 10 g/dL.|December 2010, March 2011, June 2011, September 2011, December 2011|Facilities with at least one non-missing hemoglobin record, for participants included in the primary analysis set who were on study and with available data at each time point.||percentage of facilities|Participants||Number
668890|NCT01717989|Secondary|Mean Hemoglobin Concentration by Quarter||Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.|Primary Analysis Set participants on study at each time point and with available data.||g/dL||Standard Deviation|Mean
668891|NCT01717989|Secondary|Percentage of Participants Receiving a Vitamin D Sterol|The percentage of participants receiving a vitamin D sterol (ie, calcitriol, alfacalcidol, paricalcitol or doxercalciferol) over time. Note that participants could receive more than one type of vitamin D sterol.|Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.|Primary Analysis Set participants on study at each time point||percentage of participants|||Number
668892|NCT01717989|Secondary|Percentage of Participants Receiving Phosphate Binding Agents|The percentage of participants receiving phosphate binding agents over time|Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.|Primary Analysis Set participants on study at each time point||percentage of participants|||Number
668893|NCT01717989|Secondary|Percentage of Participants Receiving Cinacalcet|The percentage of participants receiving cinacalcet (Sensipar) over time|Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.|Primary Analysis Set participants on study at each time point||percentage of participants|||Number
668894|NCT01717989|Secondary|Percentage of Participants Per Facility Receiving Erythropoietin Stimulation Agents (ESA)|The percentage of participants who received erythropoietin stimulation agents (ESA) in a facility over the course of the study. Mean and confidence interval (CI) are calculated across facilities and by using total number of participants actively receiving chronic dialysis in each facility per month as weight.|Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.|Primary Analysis Set facilities / participants on study at each time point.||percentage of participants per facility|Participants|95% Confidence Interval|Mean
668895|NCT01717989|Secondary|Percentage of Participants in Each Vascular Access Type Category|The percentage of participants in each vascular access type category out of all enrolled participants on hemodialysis over the course of the study.|Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.|Primary Analysis Set participants on study and on hemodialysis at each time point||percentage of participants|||Number
668896|NCT01717989|Primary|Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65%|"The percentage of participants within each small dialysis organization (SDO) facility with a urea reduction ratio ≥ 65% over time. URR is calculated as:
Baseline urea level - post-baseline urea level/baseline urea level * 100. Percentage of participants meeting the criteria at the facility-level were calculated for each facility first and then summarized across facilities as a continuous variable, weighted by the number of participants in a facility."|Data were collected monthly from June 2010 until September 2012|Facilities with at least one non-missing URR record for participants included in the primary analysis set (all enrolled participants) at each time point (indicated by n).||percentage of participants per facility|Participants|95% Confidence Interval|Mean
668897|NCT01717989|Primary|Percentage of Participants Per Facility With Hemoglobin > 12 g/dL|The percentage of participants within each small dialysis organization (SDO) facility with hemoglobin > 12 g/dL over time. Percentage of participants meeting the criteria at the facility-level were calculated for each facility first and then summarized across facilities as a continuous variable, weighted by the number of participants in a facility.|Data were collected monthly from June 2010 until September 2012|Facilities with at least one non-missing hemoglobin record for participants included in the primary analysis set (all enrolled participants) at each time point (indicated by n).||percentage of participants per facility|Participants|95% Confidence Interval|Mean
670015|NCT01704781|Primary|Part A: To Establish Highest Tolerated Dose of Lenalidomide, Dose-Limiting Toxicity|Number of participants in each of the three groups that experienced any dose-limiting toxicity.|31 days|ITT analysis set was used.||Participants|||Count of Participants
668899|NCT01717989|Primary|Percentage of Participants Per Facility With Hemoglobin < 10 g/dL|The percentage of participants within each small dialysis organization (SDO) facility with hemoglobin < 10 g/dL over time. Percentage of participants meeting the criteria at the facility-level were calculated for each facility first and then summarized across facilities as a continuous variable, weighted by the number of participants in a facility.|Data were collected monthly from June 2010 until September 2012|Facilities with at least one non-missing hemoglobin record for participants included in the primary analysis set (all enrolled participants) at each time point (indicated by n).||percentage of participants per facility|Participants|95% Confidence Interval|Mean
668900|NCT01717976|Secondary|Total Costs to the VHA|Assessment of VA and VA purchased care costs in 2016 dollars within 180 days from emergency department visit|180 days|0 out of 257 participants in the DISPO intervention group and 1 of 256 in the usual care group were deceased at 30 days and not included in the cost analysis.||US Dollars||Standard Deviation|Mean
668901|NCT01717976|Secondary|Number of Participants Satisfied With Health Care|Satisfaction with health care determined by 9 or 10 on the CAHPS|180 days|26 out of 257 in intervention group and 33 out of 256 participants in the usual care group had missing data at the 180 day interview for satisfaction due to missing the 180-day interview or non-response to the satisfaction question at the 180 day interview.||Participants|||Count of Participants
668902|NCT01717976|Secondary|Number of Participants Satisfied With Health Care|Satisfaction with health care determined by 9 or 10 on the CAHPS|30 days|24 out of 257 in intervention group and 38 out of 256 participants in the usual care group had missing data at the 30 day interview for satisfaction due to missing the 30-day interview or non-response to the satisfaction question at the 30 day interview.||Participants|||Count of Participants
668903|NCT01717976|Secondary|Number of Participants Satisfied With Health Care|Satisfaction with health care determined by 9 or 10 on the CAHPS|Baseline|0 out of 257 in intervention group and 2 out of 256 participants in the usual care group had missing data at baseline for satisfaction due to non-response.||Participants|||Count of Participants
668904|NCT01717976|Primary|Number of Participants Experiencing Repeat ED Use|Number of Participants Experiencing Repeat ED Use|30 days|0 out of the 257 participants in the DISPO intervention group and 1 of the 256 participants in the Usual Care group were deceased at 30 days and not included in the primary outcome analysis.||Participants|||Count of Participants
668905|NCT01717872|Secondary|Percent of Glottic Opening With the MAC Blade Lifting the Tongue and the Epiglottis|The MAC blade was inserted under the tongue to view the percent glottic opening and compared with the view with the same blade lifting the epiglottis to view the percent glottic opening.|30 seconds|||percent of glottic opening||95% Confidence Interval|Mean
668906|NCT01717872|Secondary|Percent of Glottic Opening With the Miller Blade Lifting the Epiglottis and Tongue|Percent of glottic opening (POGO) with the Miller blade lifting the epiglottis compared with the score with the same blade lifting the tongue|30 seconds|||percent of glottic opening||95% Confidence Interval|Mean
668907|NCT01717872|Primary|The View of the Larynx (Glottis Opening) as Determined by POGO Score (Percentage of Glottic Opening).|Percent of glottic opening (POGO) with the Miller blade lifting the epiglottis compared with the score with the Macintosh blade lifting the tongue|30 seconds|||percentage of Glottic opening||95% Confidence Interval|Mean
668908|NCT01717768|Other Pre-specified|AUC 0-24 Hrs After 120 mg Dose of TSX-002|AUC 0-24 hrs with PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24 hours post-dose after 1 day of treatment for Part 3.|24 hrs|All subjects that received 120 mg TSX-002 under defined Treatment conditions (timing of high-calorie, high-fat meal).||hr×ng/dL||Standard Deviation|Median
668909|NCT01717768|Other Pre-specified|Cavg 0-24 Hrs (ng/dL) After 120 mg Dose|PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24 hours post-dose after 1 day of treatment for Part 3. Mean of Cavg values from all time points for 14 subjects.|24 hrs|All subjects that received 120 mg TSX-002 under defined Treatment conditions (timing of high-calorie, high-fat meal).||ng/dL||Standard Deviation|Least Squares Mean
668910|NCT01717768|Secondary|Percentage of Subjects With Cmax ≤ 1500 ng/dL After 15 Days of Treatment 2. Percentage of Subjects With Cmax ≥ 1800 and ≤ 2500 ng/dL After 15 Days of BID Treatment 3. Percentage of Subjects With Cmax > 2500 ng/dL After 15 Days of BID Treatment|Cmax. PK samples taken at 0, 2, 4, 5, 6, 7, 9, 12, 14, 16, 17, 18, 21, 24 hours post-dose after 15 days of treatment for Part 1. PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 12, 16, 17, 18, 19, 20, 21, 22, 24 hours post-dose after 15 days of treatment for Part 2. PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 12, 13, 14, 15, 16, 17,18, 20, 24 hours post-dose after 15 days of treatment for Part 4.|15 days|All efficacy analyses were conducted based on the modified intent-to-treat (MITT) analysis population, comprised of all randomized subjects who receive at least 1 dose of study drug and have at least 1 post-baseline measurement of total serum testosterone.||percentage of subjects|||Number
668911|NCT01717768|Primary|Percentage of Subjects Achieving a 24 Hour Average Total Serum Testosterone Concentration (Cavg,0-24h) in the Range of 300 to 1050 ng/dL After 15 Days of Treatment With TSX-002|Percentage of subjects achieving a 24-hour average total serum testosterone concentration (Cavg,0-24h) in the range of 300 to 1050 ng/dL after 15 days of treatment with TSX-002. PK samples taken at 0 ,2 ,4, 5 ,6, 7, 9, 12, 14, 16, 17, 18, 21, 24 hours post-dose after 15 days of treatment for Part 1. PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 12, 16, 17, 18, 19, 20, 21, 22, 24 hours post-dose after 15 days of treatment for Part 2. PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8 ,12, 13, 14, 15, 16, 17, 18, 20, 24 hours post-dose after 15 days of treatment for Part 4.|15 days|All efficacy analyses were conducted based on the modified intent-to-treat (MITT) analysis population, comprised of all randomized subjects who receive at least 1 dose of study drug and have at least 1 post-baseline measurement of total serum testosterone.||percentage of participants|||Number
668912|NCT01717638|Secondary|Number of Subjects Reporting Unsolicited AEs After Any Vaccination.|The safety and tolerability of the 3rd dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules is reported as number of subjects with unsolicited AEs, Serious Adverse Events (SAEs), AEs leading to premature withdrawal.|From day 1 to study termination|Analysis was done on the safety population.||Number of participants|||Number
668945|NCT01717456|Secondary|MHQ Emotions at Follow Up|Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.|6 months after (6-Week) treatment ends|All subjects completing end of treatment home visit with research assistant.||units on a scale||Standard Deviation|Mean
668913|NCT01717638|Secondary|Number of Subjects Reporting Unsolicited AEs After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)|The safety and tolerability of the 3rd dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules is reported as number of subjects with Unsolicited AEs, Serious Adverse Events (SAEs), AEs leading to premature withdrawal.|From day 1 to study termination|Analysis was done on the safety population.||Number of subjects|||Number
668914|NCT01717638|Secondary|Number of Subjects Reporting Unsolicited AEs After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)|The safety and tolerability of the 5th dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 3 primary doses (at 2, 3, 4,or 2, 4, 6 months) followed by a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules in the earlier studies is reported as number of subjects with unsolicited AEs, Serious Adverse Events (SAE), AEs leading to premature withdrawal.|From day 1 to study termination|Analysis was done on the safety population.||Number of subjects|||Number
668915|NCT01717638|Secondary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age|The safety and tolerability of rMenB+OMV NZ vaccine in 4 year old children who received 2 catch up doses of rMenB+OMV NZ vaccine at 48 and 50 months, is reported as number of subjects with solicited local* and systemic adverse events.|From day 1 to day 7 after any vaccination|Analysis was done on the safety population.||Number of subjects|||Number
668916|NCT01717638|Secondary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)|The safety and tolerability of the 3rd dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules is reported as number of subjects with solicited local and systemic adverse events.|From day 1 to day 7 after vaccination|Analysis was done on the safety population.||Number of subjects|||Number
668917|NCT01717638|Secondary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)|The safety and tolerability of the 5th dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) followed by a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules in the earlier studies is reported as number of subjects with solicited local and systemic adverse events.|From day 1 to day 7 after vaccination|Analysis was done on the safety population, ie, all subjects in the Exposed population who provided post vaccination and post-baseline safety data.||Number of subjects|||Number
668918|NCT01717638|Secondary|Percentages of Subjects With 4-fold Increase in Serum Bactericidal Titers, Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age|The percentages of subjects with 4-fold increase in hSBA titers, one month following a two catch up dose of rMenB+OMV NZ at 4 years of age are reported.|Day 91 (1 month post second vaccination)|Analysis was done on FAS (Immunogenicity).||Percentages of subjects||95% Confidence Interval|Number
668919|NCT01717638|Secondary|GMRs of GMTs Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age|The GMR of GMTs(one month post dose 2/baseline) in children following a two catch up dose of rMenB+OMV NZ at 48 and 50 months of age are reported.|Day 91 (1 month post second vaccination)|Analysis was done on FAS (Immunogenicity).||Ratio||95% Confidence Interval|Geometric Mean
668920|NCT01717638|Secondary|GMTs Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age|The GMTs in children who received two catch up doses of rMenB+OMV NZ vaccine at 48 and 50 months of age are reported.|Day 91 (1 month post second vaccination)|Analysis was done on FAS (Immunogenicity).||Titers||95% Confidence Interval|Geometric Mean
668921|NCT01717638|Secondary|Percentages of Subjects With hSBA ≥1:5 and ≥1:8 in Response of Two Catch up Doses of rMenB+OMV NZ Vaccine When Administered to Children at 4 Years of Age.|"The sufficiency of immune response is reported in terms of percentages of subjects with hSBA ≥1:5 and ≥1:8 in response of two catch up doses of rMenB+OMV NZ vaccine, administered two months apart, in children at 4 years of age.
Immune response was considered sufficient if the lower limit of the two-sided 95% CI for the percentage of subjects achieving hSBA ≥ 1:5 at one month after the two-dose series was ≥ 70% for all three indicator (H44/76; 5/99 and NZ 98/254) strains.
Immune sufficiency was not applicable for M10713 strain."|Day 91 (1 month post second vaccination)|Analysis was done on FAS (Immunogenicity).||Percentages of subjects||95% Confidence Interval|Number
668922|NCT01717638|Secondary|Percentages of Subjects With a 4-fold Increase in hSBA Titers Following a Third Dose of rMenB+OMV NZ Vaccine Given at 4 Years of Age to Children Who Previously Received 2 Catch up Doses of the Same Vaccine|"The percentage of subjects with a four-fold increase in hSBA titers following a third dose of rMenB+OMV NZ vaccine, who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules,are reported.
Fourfold increase is defined as- for subjects with a pre-vaccination titer <1:2 to a post-vaccination titer ≥1:8 and for subjects with a pre-vaccination titer ≥1:2 to a post-vaccination titer ≥ 4 fold pre-vaccination titer."|Day 31 (1 month post vaccination)|Analysis was done on FAS (Immunogenicity).||Percentages of subjects||95% Confidence Interval|Number
668923|NCT01717638|Secondary|GMRs of GMTs in Children Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules.|The GMRs of GMTs following a third dose of rMenB+OMV NZ vaccine (one month post 3rd dose/persistence at 48 months) in children, who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of the same vaccine according to different schedules, are reported.|Day 31 (1 month post vaccination)|Analysis was done on FAS (Immunogenicity).||Ratio||95% Confidence Interval|Geometric Mean
668924|NCT01717638|Secondary|GMTs Following a Third Dose of rMenB+OMV NZ Vaccine in Children (at 4 Years of Age) Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules|The GMTs, one month following a third dose of rMenB+OMV NZ vaccine in 4 year old children who had previously received 2 catch up doses (at 12,14 or 18,20 or 24,26 months) of the same vaccine according to different schedules, are reported.|Day 31 (1 month post vaccination)|Analysis was done on FAS (Immunogenicity).||Titers||95% Confidence Interval|Geometric Mean
670059|NCT01704495|Secondary|Change From Baseline to Treatment Period (Day 29 to Day 56) for Use of Rescue Medication Free Days||Baseline (last 14 days before randomization) and Treatment Period (Days 29 to 56)|Full Analysis set||rescue medication free days||90% Confidence Interval|Least Squares Mean
668925|NCT01717638|Secondary|Percentages of Subjects With hSBA Titers ≥1:5 and ≥1:8 Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules|The percentages of subjects with hSBA titers ≥1:5 and hSBA titers ≥1:8 at one month after a third dose of rMenB+OMV NZ vaccine was given to children, who had previously received 2 catch up doses (at 12,14 or 18,20 or 24,26 months) of the same vaccine according to different schedules, are reported.|Day 31 (1 month post vaccination)|Analysis was done on FAS (Immunogenicity).||Percentages of subjects||95% Confidence Interval|Number
668926|NCT01717638|Secondary|Percentages of Subjects With Fourfold Increase in hSBA Titers After Receiving a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules|The fourfold increase in hSBA titers, one month after a 5th dose of rMenB+OMV NZ vaccine was given to children, who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) and a booster dose (at 12,18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is compared with the response in children who received the first dose of rMenB+OMV NZ vaccine at 4 years of age.|Day 31 (1 month post vaccination)|Analysis was done on FAS, Immunogenicity.||Percentages of subjects||95% Confidence Interval|Number
668927|NCT01717638|Secondary|Geometric Mean Ratios of GMTs in Subjects Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules|The GMRs of GMTs (one month post booster/48 months persistence), one month after a 5th dose of rMenB+OMV NZ vaccine was given children, who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) and a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is compared with the GMR (one month post 1 dose\baseline) of children who received first dose of rMenB+OMV NZ at 4 years of age.|Day 31 (1 month post vaccination)|Analysis was done on FAS (Immunogenicity).||Ratio||95% Confidence Interval|Geometric Mean
668928|NCT01717638|Secondary|GMTs in Children Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules|The GMTs, at one month after a 5th dose of rMenB+OMV NZ vaccine in children who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) and a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules, are compared with the GMTs of children who received first dose of rMenB+OMV NZ at 4 years of age.|Day 31 (1 month post vaccination)|Analysis was done on FAS (Immunogenicity).||Titers||95% Confidence Interval|Geometric Mean
668929|NCT01717638|Secondary|Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules|The Percentages of subjects with hSBA titers ≥1:5 and ≥1:8, one month after a 5th dose of rMenB+OMV NZ vaccine was given children who had previously received 3 primary doses (at 2, 3, 4,or 2, 4, 6 months) and a booster dose (at 12, 18 or 24 months) of the same vaccine according to different schedules is compared with the hSBA response of children who received first dose of rMenB+OMV NZ at 4 years of age.|Day 31 (1 month post vaccination)|Analysis was done on FAS, Immunogenicity, ie, all subjects in the enrolled population who actually received a study vaccination, and provided at least one evaluable serum sample at post baseline.||Percentages of subjects||95% Confidence Interval|Number
668930|NCT01717638|Secondary|GMRs of GMTs in Children (at 4 Years of Age) Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules|The GMRs of GMTs (48 months/one month post last vaccination) in children at 4 years of age who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules.|Day 1 (22-34 months post last MenB vaccine)|FAS, Persistency.||Ratio||95% Confidence Interval|Geometric Mean
668931|NCT01717638|Secondary|Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules|The persisting GMTs in children at 4 years of age, who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules are reported.|Day 1 (22-36 months post last MenB vaccine; baseline for naive)|FAS, Persistency.||Titers||95% Confidence Interval|Geometric Mean
668932|NCT01717638|Secondary|Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules|The antibody persistence in children at 4 year of age, who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) according to different schedules is reported as percentages of subjects with hSBA titers ≥1:5 and hSBA titers ≥1:8.|Day 1 (22-34 months post last MenB vaccine)|FAS, Persistency. Note: Reporting groups in this endpoint and in endpoints 5 and 6 received vaccination according to different schedules with respect to the groups reported in endpoints 1, 2 and 3.||Percentages of subjects||95% Confidence Interval|Number
668933|NCT01717638|Primary|Geometric Mean Ratios (GMRs) in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules|The GMRs of GMTs (48 months/one month post booster vaccination) at 4 years of age in children who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) followed by a booster dose (at 12,18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is reported.|Day 1 (24-36 months post booster dose; baseline for naive)|FAS, Persistency.||Ratio||95% Confidence Interval|Geometric Mean
668934|NCT01717638|Primary|Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules|The persisting antibody titers at 4 years of age in children who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) followed by a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is compared with the titers in naive children and reported as geometric mean titers (GMTs).|Day 1 (24-36 months post booster; baseline for naive)|FAS, Persistency.||Titers||95% Confidence Interval|Geometric Mean
668946|NCT01717456|Secondary|MHQ Emotions at End of Treatment|Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.|End of Treatment (Week 6)|All subjects completing end of treatment home visit with research assistant.||units on a scale||Standard Deviation|Mean
668935|NCT01717638|Primary|Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules|"The antibody persistence at 4 years of age in children who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) followed by a booster dose (at 12,18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is compared with the response in naïve children and reported as percentages of subjects with human serum bactericidal assay (hSBA) titers ≥1:5 and ≥1:8.
The functional bactericidal antibodies directed against serogroup B meningococci were assessed using the Serum Bactericidal Assay (SBA) using human serum as the source of exogenous complement (hSBA)."|Day 1 (24-36 months post booster; baseline for naive)|Full Analysis Set (Fas), Persistency: All subjects in the enrolled population who provided at least one evaluable serum sample at baseline (visit 1). Persistence data sets include nonvaccination and vaccination subsets of subjects from different groups with different primary vaccination schedules of MenB+Routine vaccines and routine vaccines.||Percentages of subjects||95% Confidence Interval|Number
668936|NCT01717456|Other Pre-specified|Caregiver's Ability and Willingness to Assist With ADLs at End of Treatment|"OASIS question M2100, item A: Types and sources of assistance for ADLs. Measure as moderator of treatment effectiveness. Responses range from No assistance needed in this area to Assistance needed, but no Caregivers available. Ordinal scale with 6 levels:
0= No assistance needed
Caregiver provides assistance
Caregiver needs training or support
Caregiver is unlikely to provide assistance
Unclear if caregiver will assist patient
Assistance is needed but is not available"|End of Treatment (Week 6)|Analysis population consists of all patients who provided data at end of treatment||units on a scale||Full Range|Median
668937|NCT01717456|Other Pre-specified|Patient's Living Situation at End of Treatment|OASIS question M1100: Patient living situation: This is a measure that combines who lives with the patient and the frequency that assistance is available to them throughout the day. Responses are coded on a 1-15 scale. Measure this as a moderator of treatment effectiveness.|End of Treatment (Week 6)|Analysis population consists of all patients who provided data at end of treatment||participants|||Number
668938|NCT01717456|Other Pre-specified|Depression Screening at End of Treatment|"OASIS question M1730: Depression Screening. Measure as a moderator of treatment effectiveness on categorical scale. Possible responses are:
0= No screening
Screened for depression with PHQ2 measure
Screened with PHQ2 and meets criteria for further evaluation of depression
Screened and does not meet criteria for further evaluation of depression"|End of Treatment (Week 6)|Analysis population consists of all patients providing data at end of treatment.||participants|||Number
668939|NCT01717456|Other Pre-specified|When is Patient Anxious at End of Treatment?|"OASIS question M1720: When anxious (reported or observed within the last 14 days). Measured as moderator of treatment effects on ordinal scale. Higher scores indicate a greater level of anxiousness. Responses are:
0 - None of the time
- Less often than daily
- Daily, but not constantly
- All of the time"|End of Treatment (Week 6)|Analysis population consists of all patients who provided end of treatment data.||units on a scale||Full Range|Median
668940|NCT01717456|Other Pre-specified|Ability to Reach Toilet at End of Treatment|"OASIS question M1840: Toilet transferring: Current ability to get to and from the toilet or bedside commode safely and transfer on and off toilet/commode. Measure as moderator of treatment outcomes.
A lower score is better.
Responses:
0. Able to get to and from the toilet and transfer independently with or without a device.
When reminded, assisted, or supervised by another person, able to get to and from the toilet.
Unable to get to and from the toilet but is able to use a bedside commode (with or without assistance).
Unable to get to and from the toilet or bedside commode but is able to use a bedpan/urinal independently.
Is totally dependent in toileting."|End of Treatment (Week 6)|All patients who provided data for this measure at the end of treatment.||units on a scale||Full Range|Median
668941|NCT01717456|Other Pre-specified|Change in Ambulation From Baseline to End of Treatment|"OASIS question M1860: Ambulation/locomotion: Current ability to walk safely, once in a standing position, or use a wheelchair, once in a seated position, on a variety of surfaces. Measure as a moderator of treatment effects. Responses:
0. Able to independently walk on even and uneven surfaces and negotiate stairs with or without railings (i.e., needs no human assistance or assistive device).
Requires use of a device (e.g., cane, walker) to walk alone or requires human supervision or assistance to negotiate stairs or steps or uneven surfaces.
Able to walk only with the supervision or assistance of another person at all times.
Chairfast, unable to ambulate but is able to wheel self independently.
Chairfast, unable to ambulate and is unable to wheel self.
Bedfast, unable to ambulate or be up in a chair.
Higher scores represent improvement in ability to ambulate."|Baseline, End of Treatment (Week 6)|Analysis sample consists of all patients who provided data for this questionnaire at the end of treatment. Two EMB subjects did not provide this data for unknown reasons, and 4 SC subjects did not provide this data for unknown reasons.||units on a scale||Full Range|Median
668942|NCT01717456|Other Pre-specified|Cognitive Status at End of Treatment|"OASIS question M1700: Cognitive functioning: Patient's current (day of assessment) level of alertness, orientation, comprehension, concentration, and immediate memory for simple commands. Measure as treatment moderator. Response categories are:
0 - Alert/oriented, able to focus and shift attention, comprehends and recalls task directions independently.
- Requires prompting (cuing, repetition, reminders) only under stressful or unfamiliar conditions.
- Requires assistance and some direction in specific situations (e.g., on all tasks involving shifting of attention), or consistently requires low stimulus environment due to distractibility.
- Requires considerable assistance in routine situations. Is not alert and oriented or is unable to shift attention and recall directions more than half the time.
- Totally dependent due to disturbances uch as constant disorientation, coma, persistent vegetative stte, or delirium."|End of Treatment (Week 6)|Analysis population is all patients who provided data on this measure at end of treatment. Data were missing for 2/11 in Group A and 6/8 in Group B.||units on a scale||Full Range|Median
668943|NCT01717456|Secondary|MHQ Sleep Energy at Follow Up|Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.|6 months after (6-Week) treatment ends|All subjects completing end of treatment home visit with research assistant.||units on a scale||Standard Deviation|Mean
668944|NCT01717456|Secondary|MHQ Sleep Energy at End of Treatment|Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.|End of Treatment (Week 6)|All subjects completing end of treatment home visit with research assistant.||units on a scale||Standard Deviation|Mean
668947|NCT01717456|Secondary|MHQ Personal Relationships at Follow Up|Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.|6 months after (6-Week) treatment ends|All subjects completing end of treatment home visit with research assistant.||units on a scale||Standard Deviation|Mean
668948|NCT01717456|Secondary|MHQ Personal Relationships at End of Treatment|Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.|End of Treatment (Week 6)|All subjects completing end of treatment home visit with research assistant.||units on a scale||Standard Deviation|Mean
668949|NCT01717456|Secondary|MHQ Social Limitations at Follow Up|Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.|6 months after (6-Week) treatment ends|All subjects completing end of treatment home visit with research assistant.||units on a scale||Standard Deviation|Mean
668950|NCT01717456|Secondary|MHQ Social Limitations at End of Treatment|Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.|End of Treatment (Week 6)|All subjects completing end of treatment home visit with research assistant.||units on a scale||Standard Deviation|Mean
668951|NCT01717456|Secondary|MHQ Physical Limitations at Follow Up|Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.|6 months after (6-Week) treatment ends|All subjects completing end of treatment home visit with research assistant.||units on a scale||Standard Deviation|Mean
668952|NCT01717456|Secondary|MHQ Physical Limitations at End of Treatment|Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.|End of Treatment (Week 6)|All subjects completing end of treatment home visit with research assistant.||units on a scale||Standard Deviation|Mean
668953|NCT01717456|Secondary|MHQ Role Limitations at Follow Up|Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.|6 months after (6-Week) treatment ends|All subjects completing end of treatment home visit with research assistant.||units on a scale||Standard Deviation|Mean
668954|NCT01717456|Secondary|MHQ Role Limitations at End of Treatment|Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.|End of Treatment (Week 6)|All subjects completing end of treatment home visit with research assistant.||units on a scale||Standard Deviation|Mean
668955|NCT01717456|Secondary|MHQ Incontinence Impact at Follow Up|Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.|6 months after (6-Week) treatment ends|All subjects completing end of treatment home visit with research assistant.||units on a scale||Standard Deviation|Mean
668956|NCT01717456|Secondary|MHQ Incontinence Impact at End of Treatment|Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.|End of Treatment (Week 6)|All subjects completing end of treatment home visit with research assistant.||units on a scale||Standard Deviation|Mean
668957|NCT01717456|Secondary|Admission to Nursing Home at End of Treatment|Was patient admitted to a nursing home for one or more days at any time between enrollment and follow-up 7-8 months after treatment onset.|End of Treatment (Week 6)|Analysis sample was all patients who provided data at end of treatment.||participants|||Number
668958|NCT01717456|Secondary|Urinary Incontinence Status Change From Baseline to End of Treatment|"OASIS question M1610: Urinary incontinence or urinary catheter presence. Response options are:
0 - No incontinence or catheter (includes anuria or ostomy for urinary drainage)
- Patient is incontinent
- Patient requires a urinary catheter (i.e., external, indwelling, intermittent, suprapubic)"|Baseline, end of treatment (week 6)|Analysis population consists of all patients who provided end of treatment data. Data were missing for 2/11 in Group A and 6/8 in Group B.||units on a scale||Full Range|Median
668959|NCT01717456|Secondary|Fecal Incontinence Frequency at End of Treatment|"OASIS question M1620: Bowel incontinence frequency. Response options are:
0 - Very rarely or never has bowel incontinence
- Less than once weekly
- One to three times weekly
- Four to six times weekly
- On a daily basis
- More often than once daily"|End of Treatment (Week 6)|Analysis population consists of all patients who provided data at the end of treatment visit. Data is missing for 2/11 in Group A and 6/8 in Group B.||units on a scale||Full Range|Median
668960|NCT01717456|Secondary|Zarit Caregiver Burden Scale at Follow Up|Validated questionnaire developed to assess the psychosocial and health burden experienced by a family caregiver of the identified patient. The total score range is from 0 to 66. Higher scores indicate greater severity of burden on the family.|6 months after (6-Week) treatment ends|Family caregivers of patients completing the study. Some caregivers declined or no caregiver was available.||units on a scale||Standard Deviation|Mean
668961|NCT01717456|Secondary|Zarit Caregiver Burden Scale at End of Treatment|Validated questionnaire developed to assess the psychosocial and health burden experienced by a family caregiver of the identified patient. The 22-items ask about behaviors and feelings of caregivers on a 6-step ordinal scale (never to almost always). The scale is valid for caregivers of individuals with diverse chronic disabilities (dementia, advanced cancer, acquired brain injury). The scale has good internal consistency. Total scores range 0-66, and 21 or greater is interpreted as high burden (J Clin Epidemiol 2010;63:535-42). Subscales (role and personal strain) have been described but are unreliable so total scores were used.|End of Treatment (Week 6)|Family caregivers of patients completing the study. Some caregivers declined or no caregiver was available.||units on a scale||Standard Deviation|Mean
668962|NCT01717456|Secondary|MHQ Severity Scale at Follow Up|Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0 to 100. Higher scores indicate greater impact on quality of life.|6 months after (6-Week) treatment ends|All subjects completing end of treatment home visit with research assistant.||units on a scale||Standard Deviation|Mean
679155|NCT01587079|Secondary|Proportion of Subjects Achieving >=12% Improvement in FEV1 on Day 1|Proportion of subjects achieving >=12% improvement in FEV1|Day 1|MITT||Percentage|||Number
668963|NCT01717456|Secondary|MHQ Severity Scale at End of Treatment|Quality of life scale specific to fecal incontinence. Severity is one of 8 MHQ subscales. This subscale has a range of 0 to 100. Higher scores indicate greater severity of QOL impact.|End of Treatment (Week 6)|All subjects completing end of treatment home visit with research assistant.||units on a scale||Standard Deviation|Mean
668964|NCT01717456|Secondary|Adequate Relief of Fecal Incontinence at Follow Up|"At follow up 6 months after the end of treatment, the subject is asked, Compared to before you started home health care, have you experienced adequate relief of your fecal incontinence symptoms? [Responses: yes or no]. A responder to treatment is a subject who answers yes. When applied to group analysis, a treatment is regarded as effective if the responder rate is at least 10% greater in the active treatment arm compared to the control arm. This measure is not recorded at baseline because it is undefined until treatment has been provided."|6 months after (6-Week) treatment ends|Data not available for 3/7 Educational-Medical-Behavioral group subject and for 2/2 Standard Care subjects.||participants|||Number
668965|NCT01717456|Secondary|Adequate Relief of Fecal Incontinence at End of Treatment|"At the end of treatment, the subject is asked, Compared to before you started home health care, have you experienced adequate relief of your fecal incontinence symptoms? [Responses: yes or no]. A responder is anyone answering yes. A treatment would be judged successful if there was at least 10% more responders in the active compared to the control groups."|End of Treatment (Week 6)|Data not available for 1/11 Educational-Medical-Behavioral group subject and for 2/8 Standard Care subjects.||participants|||Number
668966|NCT01717456|Primary|Fecal Incontinence Severity Index (FISI) at Follow-Up (FU)|At follow up 6 months after the end of treatment, the subject reports the frequency of occurrence of 4 types of fecal incontinence (solid, liquid, mucus, and gas incontinence) in the past month. These four responses are multiplied by empirically derived patient weights and the values are added together. Range is 0-61. No data is available to interpret the scale as mild, moderate, or severe fecal incontinence.|6 months after (6-Week) treatment ends|The analysis sample consists of all patients who provided data at the 6 month FU visit.||units on a scale||Standard Deviation|Mean
668967|NCT01717456|Primary|Fecal Incontinence Severity Index (FISI) at End of Treatment|At the end of treatment, the FISI requires the patient to report the frequency of occurrence of 4 types of fecal incontinence (solid, liquid, mucus, and gas incontinence) in the past month. These four responses are multiplied by empirically derived patient weights and the values are added together. Range of scores is 0-61. Higher scores show more severe fecal incontinence.|End of Treatment (Week 6)|Analysis population includes all participants who provided end of treatment data to research assistants during a home visit. One subject from the EMB treatment did not provide data, and 1 subject from the SC group did not provide these data.||units on a scale||Standard Deviation|Mean
668968|NCT01717391|Secondary|Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.|Lymphocyte counts measurements expressed in standardized toxicity severity grades (Common Terminology Criteria for Adverse Events, v4.03) measured once weekly during combined chemotherapy and radiation therapy, then once at 30 day follow-up, and once at 1 year follow-up|baseline, weekly during radiation treatment for up to 5 weeks, 30 days and 1 year after treatment|This group includes all tumor types treated in this clinical trial and provides an overall averages.||Participants|||Count of Participants
668969|NCT01717391|Secondary|Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)|Absolute neutrophil counts (ANCs) measurements expressed in standardized toxicity severity grades (Common Terminology Criteria for Adverse Events, v4.03) measured once weekly during combined chemotherapy and radiation therapy, then once at 30 day follow-up, and once at 1 year follow-up|baseline, weekly during radiation treatment for up to 5 weeks, 30 days and 1 year after treatment|This group includes all tumor types treated in this clinical trial and provides an overall averages.||Participants|||Count of Participants
668970|NCT01717391|Secondary|Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.|Platelet cell counts measurements expressed in standardized toxicity severity grades (Common Terminology Criteria for Adverse Events, v4.03) measured once weekly during combined chemotherapy and radiation therapy, then once at 30 day follow-up, and once at 1 year follow-up|baseline, weekly during radiation treatment for up to 5 weeks, 30 days and 1 year after treatment|This group includes all tumor types treated in this clinical trial and provides an overall averages.||Participants|||Count of Participants
668971|NCT01717391|Secondary|Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts|White blood cell counts measurements expressed in standardized toxicity severity grades (Common Terminology Criteria for Adverse Events, v4.03) measured weekly during combined chemotherapy and radiation therapy treatment and then once at 30 day follow-up and at 1 year follow-up|baseline, weekly during radiation treatment for up to 5 weeks, 30 days and 1 year after treatment|This group includes all tumor types treated in this clinical trial and provides an overall averages.||Participants|||Count of Participants
668972|NCT01717391|Secondary|Chemotherapy Compliance|The number of participants who had chemotherapy withheld at least once for low blood counts.|At 24 months|||Participants|||Count of Participants
668973|NCT01717391|Primary|Percent Difference From Baseline IMRT Plan (%)|The difference in volume of bone marrow receiving radiation using a bone-marrow-sparing radiation plan compared to a standard radiation plan (IMRT), expressed as a percentage. Both plans are patient-specific. Bone-marrow is identified using the baseline FLT PET/CT obtained pre-imaging. Active bone marrow is considered to have an uptake value (SUV) of 2, 3, or 4. The standard IMRT plan was created using the criteria of the National Cancer Institute's Radiation Therapy Oncology Group study RTOG-0418. Radiation doses evaluated are 5 Gray, 10 Gray, 20 Gray, and 30 Gray. The change in dose to tumor is also provided. A negative value indicates that more bone marrow or tissue was spared using the bone-marrow sparing plan.|Baseline (pre-treatment)|All participants who received an FLT PET/CT during radiation simulation.||Percent difference (%)||Standard Deviation|Mean
668982|NCT01717326|Secondary|Mean Time to First Achievement of Undetectable Hepatitis C Virus Ribonucleic Acid (HCV RNA)|Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. Kaplan Meier summary statistics were used to characterize the time to first achievement of undetectable HCV RNA.|From first dose of study medication until first achievement of undetectable HCV RNA (up to 18 weeks of treatment)|FAS; all randomized participants who received ≥1 dose of study treatment.||days||Standard Error|Mean
668974|NCT01717326|Secondary|Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After the End of All Study Therapy (SVR24)|Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a LLoQ of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). SVR24 was defined as HCV RNA <25 IU/ml at 24 weeks after the end of all study therapy. 95% confidence intervals provided based on the Clopper-Pearson method.|24 weeks after end of therapy (up to 42 weeks)|The PP population; all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point.||percentage of participants||95% Confidence Interval|Number
668975|NCT01717326|Secondary|Percentage of Participants Achieving Sustained Virologic Response 4 Weeks After the End of All Therapy (SVR4)|Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a LLoQ of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). SVR4 was defined as HCV RNA <25 IU/ml at 4 weeks after the end of all study therapy. 95% confidence intervals provided based on the Clopper-Pearson method.|4 weeks after end of therapy (up to 22 weeks)|The PP population; all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point.||percentage of participants||95% Confidence Interval|Number
668976|NCT01717326|Secondary|Percentage of Participants Achieving HCV RNA <25 IU/mL at Week 12|HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a LLoQ of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). The percentage of participants achieving HCV RNA levels <25 IU/ml and accompanying 95% CIs were reported at TW12 for each treatment arm of the PP Population (as applicable). 95% confidence intervals provided based on the Clopper-Pearson method.|Week 12|The PP population; all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point. The B1, C1, and C2 arms only received 8 weeks of treatment and were thus excluded from this analysis.||percentage of participants||95% Confidence Interval|Number
668977|NCT01717326|Secondary|Percentage of Participants Achieving HCV RNA <25 IU/mL at Week 4|HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a LLoQ of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). The percentage of participants achieving HCV RNA levels <25 IU/ml and accompanying 95% CIs were reported at TW4 for each treatment arm of the PP Population. 95% confidence intervals provided based on the Clopper-Pearson method.|Week 4|The PP population; all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point.||percentage of participants||95% Confidence Interval|Number
668978|NCT01717326|Secondary|Percentage of Participants Achieving HCV RNA <25 IU/mL at Week 2|HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a LLoQ of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). The percentage of participants achieving HCV RNA levels <25 IU/ml and accompanying 95% CIs were reported at TW2 for each treatment arm of the PP Population. 95% confidence intervals provided based on the Clopper-Pearson method.|Week 2|The PP population; all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point.||percentage of participants||95% Confidence Interval|Number
668979|NCT01717326|Secondary|Percentage of Participants Achieving Undetectable HCV RNA at Week 12|HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. Undetectable HCV RNA was defined as below the 15.1 IU/ml limit of detection. The percentage of participants achieving undetectable HCV RNA and accompanying 95% CIs were reported at TW12 for each treatment arm of the PP Population (as applicable). 95% confidence intervals provided based on the Clopper-Pearson method.|Week 12|The PP population; all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point. The B1, C1, and C2 arms only received 8 weeks of treatment and were thus excluded from this analysis.||percentage of participants||95% Confidence Interval|Number
668980|NCT01717326|Secondary|Percentage of Participants Achieving Undetectable HCV RNA at Week 4|HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. Undetectable HCV RNA was defined as below the 15.1 IU/ml limit of detection. The percentage of participants achieving undetectable HCV RNA and accompanying 95% CIs were reported at TW4 for each treatment arm of the PP Population. 95% confidence intervals provided based on the Clopper-Pearson method.|Week 4|The PP population; all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point.||percentage of participants||95% Confidence Interval|Number
668981|NCT01717326|Secondary|Percentage of Participants Achieving Undetectable HCV RNA at Week 2|HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. Undetectable HCV RNA was defined as below the 15.1 IU/ml limit of detection. The percentage of participants achieving undetectable HCV RNA and accompanying 95% CIs were reported at TW2 for each treatment arm of the PP Population. 95% confidence intervals provided based on the Clopper-Pearson method.|Week 2|The PP population; all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point.||percentage of participants||95% Confidence Interval|Number
670060|NCT01704495|Secondary|Change From Baseline to Treatment Period (Day 1 to Day 28) for Use of Rescue Medication Free Days||Baseline (last 14 days before randomization) and Treatment Period (Days 1 to 28)|Full analysis set||rescue medication free days||90% Confidence Interval|Least Squares Mean
668983|NCT01717326|Primary|Percentage of Participants Discontinuing Study Therapy Due to an AE During the Treatment Period and First 14 Follow-up Days|An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR’s product, was also an AE.|From Day 1 [post-dose] through 14 days following last dose of study drug (up to 20 weeks)|APaT population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).||percentage of participants||95% Confidence Interval|Number
668984|NCT01717326|Primary|Percentage of Participants Experiencing at Least One Adverse Event (AE) During the Treatment Period and First 14 Follow-up Days|An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR’s product, was also an AE.|From Day 1 [post-dose] through 14 days following last dose of study drug (up to 20 weeks)|All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).||percentage of participants||95% Confidence Interval|Number
668985|NCT01717326|Primary|Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After the End of All Study Therapy (SVR12)|Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a lower limit of quantification of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). SVR12 was defined as HCV RNA <25 IU/ml at 12 weeks after the end of all study therapy. 95% confidence intervals provided based on the Clopper-Pearson method.|12 weeks after end of therapy (up to 30 weeks)|The Per-Protocol (PP) population; all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point.||percentage of participants||95% Confidence Interval|Number
668986|NCT01717313|Post-Hoc|Change From Baseline in 2-hour PMG at Week 24 (Phase A, Per-Protocol Population)|"Blood glucose was measured 2 hours after a meal (2-hour PMG). 2-hour PMG is expressed as mg/dL. This change from baseline in 2-hour PMG reflects the Week 24 2-hour PMG minus the Week 0 2-hour PMG.
A post-hoc sensitivity analysis was performed that excluded participants in both treatment groups who were found to have used prohibited metformin (see results above for a description of the use of prohibited metformin)."|Baseline and Week 24|The Per Protocol population excluded participants from the FAS population who either had <75% drug compliance or used a prohibited medication (including metformin).||mg/dL||95% Confidence Interval|Least Squares Mean
668987|NCT01717313|Post-Hoc|Change From Baseline in FPG at Week 24 (Phase A, Per-Protocol Population)|"Blood glucose was measured on a fasting basis (collected after an 10-hour fast). FPG is expressed as mg/dL. This change from baseline reflects the FPG level at Week 24 minus the FPG level at Week 0.
A post-hoc sensitivity analysis was performed that excluded participants in both treatment groups who were found to have used prohibited metformin (see results above for a description of the use of prohibited metformin)."|Baseline and Week 24|The Per-Protocol population excluded participants from the FAS population who either had <75% drug compliance or used a prohibited medication (including metformin).||mg/dL||95% Confidence Interval|Least Squares Mean
668988|NCT01717313|Post-Hoc|Change From Baseline in A1C at Week 24 (Phase A, Per-Protocol Population)|"A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Thus, this change from baseline reflects the Week 24 A1C minus the Week 0 A1C.
A post-hoc sensitivity analysis was performed that excluded participants in both treatment groups who were found to have used prohibited metformin (see results above for a description of the use of prohibited metformin)."|Baseline and Week 24|The Per-Protocol population excluded participants from the FAS population who either had <75% drug compliance or used a prohibited medication (including metformin).||Percent||95% Confidence Interval|Least Squares Mean
668989|NCT01717313|Secondary|Change From Baseline in FPG at Week 54 (Phase A + Phase B, FAS Population)|"Blood glucose was measured on a fasting basis (collected after an 10-hour fast). FPG is expressed as mg/dL. This change from baseline reflects the FPG level at Week 54 minus the FPG level at Week 0.
The results of the study at Week 54 may have been confounded by use of prohibited metformin (see results above for description of the use of prohibited metformin)."|Baseline and Week 54|The FAS population was comprised of all participants who received at least one dose of study treatment and have a baseline measurement or a post-randomization measurement for the analysis endpoint after at least one dose of study treatment.||mg/dL||95% Confidence Interval|Least Squares Mean
668990|NCT01717313|Secondary|Percentage of Participants Who Achieve an A1C Goal of <6.5% at Week 54 (Phase A + Phase B, FAS Population)|"A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). The percentage of participants who achieved A1C values <6.5% (48 mmol/mol) in the FAS population at Week 54.
The results of the study at Week 54 may have been confounded by use of prohibited metformin (see results above for description of the use of prohibited metformin)."|Week 54|The FAS population was comprised of all participants who received at least one dose of study treatment and have a baseline measurement for the analysis endpoint and a post-randomization measurement for the analysis endpoint after at least one dose of study treatment, and estimated using standard multiple imputation techniques.||Percentage of participants||95% Confidence Interval|Number
669008|NCT01717287|Secondary|Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count|This outcome is a measure of immunological response to treatment|Baseline and Week 24|The population analyzed included all participants who received at least one dose of study drug, had baseline evaluation (required for change from baseline endpoints only), and had Week 24 evaluation||cells/mm^3||95% Confidence Interval|Mean
679156|NCT01587079|Secondary|Time to Onset of Action (>10% Improvement in FEV1) on Day 1|Time to onset of action (>10% improvement in FEV1)|Day 1|MITT||Percentage|||Number
668991|NCT01717313|Secondary|Percentage of Participants Who Achieve an A1C Goal of <7% (53 mmol/Mol) at Week 54 (Phase A + Phase B, FAS Population)|"The percentage of participants who achieved A1C values <7.0% (53 mmol/mol) in the FAS population at Week 54.
The results of the study at Week 54 may have been confounded by use of prohibited metformin (see results above for description of the use of prohibited metformin)."|Week 54|The FAS population was comprised of all participants who received at least one dose of study treatment and have a baseline measurement for the analysis endpoint and a post-randomization measurement for the analysis endpoint after at least one dose of study treatment, and estimated using standard multiple imputation techniques.||Percentage of participants||95% Confidence Interval|Number
668992|NCT01717313|Secondary|Change From Baseline in A1C at Week 54 (Phase A + Phase B, FAS Population)|"A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Thus, this change from baseline reflects the Week 54 A1C minus the Week 0 A1C.
The results of the study at Week 54 may have been confounded by use of prohibited metformin (see results above for description of the use of prohibited metformin)."|Baseline and Week 54|The FAS population was comprised of all participants who received at least one dose of study treatment and have a baseline measurement or a post-randomization measurement for the analysis endpoint after at least one dose of study treatment.||Percent||95% Confidence Interval|Least Squares Mean
668993|NCT01717313|Secondary|Change From Baseline in 2-hour Post Meal Glucose (PMG) at Week 24 (Phase A, FAS Population)|"Blood glucose was measured 2 hours after a meal (2-hour PMG). 2-hour PMG is expressed as mg/dL. This change from baseline in 2-hour PMG reflects the Week 24 2-hour PMG minus the Week 0 2-hour PMG.
Because it was discovered that in another omarigliptin study (MK-3102-028, NCT01814748) subjects had taken metformin (prohibited per protocol, and taken without investigator knowledge), after unblinding of Phase A of this study, an analysis of metformin levels was performed on stored Week 18 blood samples. Of the subjects not rescued with metformin prior to Week 18, 10% in the omarigliptin group and 20% in the placebo group had levels showing that they were taking metformin (prohibited per protocol). The use of prohibited metformin disproportionately by the placebo group may have resulted in a smaller than expected treatment effect for efficacy outcome measures (see post-hoc analysis)."|Baseline and Week 24|The FAS population was comprised of all participants who received at least one dose of study treatment and have a baseline measurement or a post-randomization measurement for the analysis endpoint after at least one dose of study treatment.||mg/dL||95% Confidence Interval|Least Squares Mean
668994|NCT01717313|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Phase A, FAS Population)|"Blood glucose was measured on a fasting basis (collected after an 10-hour fast). FPG is expressed as mg/dL. This change from baseline reflects the FPG level at Week 24 minus the FPG level at Week 0.
Because it was discovered that in another omarigliptin study (MK-3102-028, NCT01814748) subjects had taken metformin (prohibited per protocol, and taken without investigator knowledge), after unblinding of Phase A of this study, an analysis of metformin levels was performed on stored Week 18 blood samples. Of the subjects not rescued with metformin prior to Week 18, 10% in the omarigliptin group and 20% in the placebo group had levels showing that they were taking metformin (prohibited per protocol). The use of prohibited metformin disproportionately by the placebo group may have resulted in a smaller than expected treatment effect for efficacy outcome measures (see post-hoc analysis)."|Baseline and Week 24|The FAS population was comprised of all participants who received at least one dose of study treatment and have a baseline measurement or a post-randomization measurement for the analysis endpoint after at least one dose of study treatment.||mg/dL||95% Confidence Interval|Least Squares Mean
668995|NCT01717313|Secondary|Percentage of Participants Who Achieve an A1C Goal of <6.5% (48 mmol/Mol) at Week 24 (Phase A, FAS Population)|"A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). The percentage of participants who achieved A1C values <6.5% (48 mmol/mol) in the FAS population at Week 24.
Because it was discovered that in another omarigliptin study (MK-3102-028, NCT01814748) subjects had taken metformin (prohibited per protocol, and taken without investigator knowledge), after unblinding of Phase A of this study, an analysis of metformin levels was performed on stored Week 18 blood samples. Of the subjects not rescued with metformin prior to Week 18, 10% in the omarigliptin group and 20% in the placebo group had levels showing that they were taking metformin (prohibited per protocol). The use of prohibited metformin disproportionately by the placebo group may have resulted in a smaller than expected treatment effect for efficacy outcome measures (see post-hoc analysis)."|Week 24|The FAS population was comprised of all participants who received at least one dose of study treatment and have a baseline measurement for the analysis endpoint and a post-randomization measurement for the analysis endpoint after at least one dose of study treatment, and estimated using standard multiple imputation techniques.||Percentage of participants||95% Confidence Interval|Number
668996|NCT01717313|Secondary|Percentage of Participants Who Achieve an A1C Goal of <7% (53 mmol/Mol) at Week 24 (Phase A, FAS Population)|"A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). The percentage of participants who achieved A1C values <7.0% (53 mmol/mol) in the FAS population at Week 24.
Because it was discovered that in another omarigliptin study (MK-3102-028, NCT01814748) subjects had taken metformin (prohibited per protocol, and taken without investigator knowledge), after unblinding of Phase A of this study, an analysis of metformin levels was performed on stored Week 18 blood samples. Of the subjects not rescued with metformin prior to Week 18, 10% in the omarigliptin group and 20% in the placebo group had levels showing that they were taking metformin (prohibited per protocol). The use of prohibited metformin disproportionately by the placebo group may have resulted in a smaller than expected treatment effect for efficacy outcome measures (see post-hoc analysis)."|Week 24|The FAS population was comprised of all participants who received at least one dose of study treatment and have a baseline measurement for the analysis endpoint and a post-randomization measurement for the analysis endpoint after at least one dose of study treatment, and estimated using standard multiple imputation techniques.||Percentage of participants||95% Confidence Interval|Number
669009|NCT01717287|Primary|Percentage of Participants Who Discontinued Study Treatment Due to a Clinical Adverse Experience|A clinical adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience.|Up to Week 24|All patients as treated population included all enrolled participants who received at least one dose of study drug||Percentage of participants|||Number
668997|NCT01717313|Primary|Percentage of Participants Who Discontinued From the Study Drug Due to an Adverse Event (Phase A + Phase B, Excluding Data After Glycemic Rescue, Safety Population)|"An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of preexisting conditions.
This analysis may have been confounded by use of prohibited metformin (see results above for description of the use of prohibited metformin)."|Up to 57 weeks|The APaT population included all participants who received at least one dose of study drug.||Percentage of participants|||Number
668998|NCT01717313|Primary|Percentage of Participants Who Experienced at Least One Adverse Event (Phase A + Phase B, Excluding Data After Glycemic Rescue, Safety Population)|"An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of preexisting conditions.
This analysis may have been confounded by use of prohibited metformin (see results above for description of the use of prohibited metformin)."|Up to 57 weeks|The APaT population included all participants who received at least one dose of study drug.||Percentage of participants|||Number
668999|NCT01717313|Primary|Percentage of Participants Who Discontinued From the Study Drug Due to an Adverse Event in Phase A (Excluding Data After Glycemic Rescue, Safety Population)|"An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of preexisting conditions.
This analysis may have been confounded by use of prohibited metformin (see results above for description of the use of prohibited metformin)."|Up to 24 weeks|The APaT population included all participants who received at least one dose of study drug.||Percentage of participants|||Number
669000|NCT01717313|Primary|Percentage of Participants Who Experienced at Least One Adverse Event in Phase A (Excluding Data After Glycemic Rescue, Safety Population)|"An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of preexisting conditions.
This analysis may have been confounded by use of prohibited metformin (see results above for description of the use of prohibited metformin)."|Up to 27 weeks|The All-Participants-as-Treated (APaT) population included all participants who received at least one dose of study drug.||Percentage of participants|||Number
669001|NCT01717313|Primary|Change From Baseline in Hemoglobin A1c (A1C) at Week 24 (Phase A, FAS Population)|"A1C (%) is used to report average blood glucose levels over prolonged periods of time.
Because it was discovered that in another omarigliptin study (MK-3102-028, NCT01814748) subjects had taken metformin (prohibited per protocol, and taken without investigator knowledge), after unblinding of Phase A of this study, an analysis of metformin levels was performed on stored Week 18 blood samples. Of the subjects not rescued with metformin prior to Week 18, 10% in the omarigliptin group and 20% in the placebo group had levels showing that they were taking metformin (prohibited per protocol). The use of prohibited metformin disproportionately by the placebo group may have resulted in a smaller than expected treatment effect for efficacy outcome measures (see post-hoc analysis)."|Baseline and Week 24|The Full Analysis Set (FAS) population was comprised of all participants who received at least one dose of study treatment and have a baseline measurement for the analysis endpoint and a post-randomization measurement for the analysis endpoint after at least one dose of study treatment.||Percent||95% Confidence Interval|Least Squares Mean
669002|NCT01717287|Secondary|Percentage of Participants Achieving HIV RNA <200 Copies/mL|This outcome is a measure of virological (anti-retroviral) response to treatment. Plasma HIV RNA was measured using the Abbott RealTime HIV-1 assay, which has a linear range of 40 HIV RNA copies/mL to 10 million HIV RNA copies/mL|Week 24|Full analysis set included all participants who received at least one dose of study drug, had baseline evaluation, and had at least one postbaseline evaluation||Percentage of participants||95% Confidence Interval|Number
669003|NCT01717287|Secondary|Percentage of Participants Achieving HIV RNA <40 Copies/mL|This outcome is a measure of virological (anti-retroviral) response to treatment. Plasma HIV RNA was measured using the Abbott RealTime HIV-1 assay, which has a linear range of 40 HIV RNA copies/mL to 10 million HIV RNA copies/mL|Week 24|Full analysis set included all participants who received at least one dose of study drug, had baseline evaluation, and had at least one postbaseline evaluation||Percentage of participants||95% Confidence Interval|Number
669004|NCT01717287|Secondary|Percentage of Participants Achieving >=1 log10 Reduction From Baseline in Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) or Had an HIV RNA Assessment of <200 Copies/mL|This outcome is a measure of virological (anti-retroviral) response to treatment. Plasma HIV RNA was measured using the Abbott RealTime HIV-1 assay, which has a linear range of 40 HIV RNA copies/mL to 10 million HIV RNA copies/mL|Week 24|Full analysis set included all participants who received at least one dose of study drug, had baseline evaluation (required for change from baseline endpoints only), and had at least one postbaseline evaluation||Percentage of participants||95% Confidence Interval|Number
669005|NCT01717287|Primary|Percentage of Participants Who Discontinued Study Treatment Due to a Laboratory Adverse Experience|A laboratory adverse experience is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience.|Up to Week 24|All patients as treated population included all enrolled participants who received at least one dose of study drug||Percentage of participants|||Number
669006|NCT01717287|Primary|Percentage of Participants With at Least One Laboratory Adverse Experience|A laboratory adverse experience is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience.|Up to Week 26|All patients as treated population included all enrolled participants who received at least one dose of study drug||Percentage of participants|||Number
669007|NCT01717287|Secondary|Change From Baseline in CD4 Cell Percentage|This outcome is a measure of immunological response to treatment|Baseline and Week 24|The population analyzed included all participants who received at least one dose of study drug, had baseline evaluation (required for change from baseline endpoints only), and had Week 24 evaluation||Percentage change||95% Confidence Interval|Mean
669010|NCT01717287|Primary|Percentage of Participants With at Least One Clinical Adverse Experience|A clinical adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience.|Up to Week 26|All patients as treated population included all enrolled participants who received at least one dose of study drug||Percentage of participants|||Number
669017|NCT01717040|Primary|Change in Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score|Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) is designed to assess the severity of depressive symptoms. Total scores can range from 0 to 84 with higher scores indicating a higher severity of depressive symptoms|Baseline and Week 8|||units on a scale||Standard Error|Least Squares Mean
669018|NCT01717014|Secondary|Usability: Manueverability|Manueverability measured by surgeon usability questionnaire. Question: Maneuverability of Radial reload during the procedure was adequate|Operatively|||% of cases surgeon agree/strongly agree|||Number
669019|NCT01717014|Secondary|Usability: Access|Access measured by surgeon usability questionnaire|Operatively|||% of cases surgeon agree/strongly agree|||Number
669020|NCT01717014|Secondary|Usability: Visibility|Visibility measured by surgeon usability questionnaire.|Operatively|||% of cases surgeon agree/strongly agree|||Number
669021|NCT01717014|Primary|Distal Margins|The ability to achieve adequate distal margins (defined as >2cm [or >1cm with clear histologic evaluation]) in the low rectum.|Operative|||participants|||Number
669022|NCT01717014|Primary|Staple Line|The surgeons ability to achieve a staple line at the desired level of the rectum.|Operative|||participants|||Number
669023|NCT01716754|Secondary|Change From Baseline in Mean Number of Puffs of Morning, Evening and Total Daily Asthma Rescue Medication|Participants recorded their use of rescue medication into an electronic diary (eDiary). A negative change from baseline indicates improvement.|Baseline, Week 16|The full analysis set (FAS) for the QGE031 240 mg q2w, placebo to QGE031 240 mg q2w and Omalizumab groups (n=120,49,131) was considered for the analysis. Only participants who had both baseline and week 16 values were analyzed. The FAS included randomized participants who received at least one dose of study drug.||Number of puffs||Standard Error|Least Squares Mean
669024|NCT01716754|Secondary|Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Score|The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments that are most important to participants with asthma. The 32 items in the AQLQ were divided into four domain-specific scores and a total score as follows: Activity limitations = Mean of Items 1, 2, 3, 4, 5, 11, 19, 25, 28, 31, 32 (11 items); Symptoms = Mean of Items 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 29, 30 (12 items); Emotional function = Mean of Items 7, 13, 15, 21, 27 (5 items); Environmental stimuli = Mean of Items 9, 17, 23, 26 (4 items); and Overall Score = Mean of Items 1 to 32 (32 items). Each item of the AQLQ was equally weighted and scored along a 7-point scale, where 1 indicates maximal impairment and 7 indicates no impairment. Thus, higher scores indicate better asthma-related quality of life. The mean overall score ranged from 1 to 7. A positive change from baseline indicates improvement.|Baseline, Week 16, Week 28|The FAS for the QGE031 240 mg q2w, placebo to QGE031 240 mg q2w and Omalizumab groups (n=120,49,131) was considered for the analysis. Participants who had values at both baseline and the post baseline time point were analyzed for that post baseline time point. The FAS included randomized participants who received at least one dose of study drug.||Score on a scale||Standard Deviation|Mean
669036|NCT01716585|Secondary|Percentage of HCV Genotype 1a-infected Participants With Sustained Virologic Response 12 Weeks After Treatment|The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of active study drug|Intent-to-treat (ITT) Population: All randomized participants in the Double-blind ABT-450/r/ABT-267 and ABT-333, plus RBV treatment arm with HCV genotype 1a who received at least 1 dose of blinded study drug.||percentage of participants|||Number
669025|NCT01716754|Secondary|Percentage of Participants With a Change From Baseline in ACQ-7 Score Less Than -1.1|The ACQ-7 measures asthma symptom control and consisted of 7 items: 5 on symptom assessment, 1 on rescue bronchodilator use and 1 on airway caliber (FEV1 % predicted). All 7 questions of the ACQ were equally weighted. Items 1-6 scored along a 7-point response scale, where 0 = good controlled and 6 = poor controlled. The 7th item on % predicted FEV1 (pre-bronchodilator) was scored by clinic staff on a 7-point scale (0 – > 95%; 1 – 90-95%; 2 – 80-89%; 3 – 70-79%; 4 – 60-69%; 5 – 50-59%; 6 – < 50%). The average score of the 7 questions was calculated as the sum of scores divided by the number of questions that were answered by the participants, as long as there were at least 6 questions answered and the missing items were neither question 1 nor question 7.|Week 16|The full analysis set (FAS) for the QGE031 240 mg q2w, placebo to QGE031 240 mg q2w and Omalizumab groups (n=120,49,131) was considered for the analysis. Only participants who had week 16 values were analyzed. The FAS included randomized participants who received at least one dose of study drug.||Percentage of participants|||Number
669026|NCT01716754|Secondary|Change From Baseline in ACQ-7 Score|The ACQ-7 measures asthma symptom control and consisted of 7 items: 5 on symptom assessment, 1 on rescue bronchodilator use and 1 on airway caliber (FEV1 % predicted). All 7 questions of the ACQ were equally weighted. Items 1-6 scored along a 7-point response scale, where 0 = good controlled and 6 = poor controlled. The 7th item on % predicted FEV1 (pre-bronchodilator) was scored by clinic staff on a 7-point scale (0 – > 95%; 1 – 90-95%; 2 – 80-89%; 3 – 70-79%; 4 – 60-69%; 5 – 50-59%; 6 – < 50%). The average score of the 7 questions was calculated as the sum of scores divided by the number of questions that were answered by the participants, as long as there were at least 6 questions answered and the missing items were neither question 1 nor question 7. A negative change from baseline indicates improvement.|Baseline, Weeks 4, 8, 12, 16 and 28|The FAS for the QGE031 240 mg q2w, placebo to QGE031 240 mg q2w and Omalizumab groups (n=120,49,131) was considered for the analysis. Participants who had values at both baseline and the post baseline time point were analyzed for that post baseline time point. The FAS included randomized participants who received at least one dose of study drug.||Score on a scale||Standard Deviation|Mean
669027|NCT01716754|Primary|Percentage of QGE031 Participants With Clinically Important Improvement of <= -0.5 in the Asthma Control Questionnaire 7 (ACQ-7) Score Compared to Placebo|The ACQ-7 measures asthma symptom control and consisted of 7 items: 5 on symptom assessment, 1 on rescue bronchodilator use and 1 on airway caliber (FEV1 % predicted). All 7 questions of the ACQ were equally weighted. Items 1-6 scored along a 7-point response scale, where 0 = good controlled and 6 = poor controlled. The 7th item on % predicted FEV1 (pre-bronchodilator) was scored by clinic staff on a 7-point scale (0 – > 95%; 1 – 90-95%; 2 – 80-89%; 3 – 70-79%; 4 – 60-69%; 5 – 50-59%; 6 – < 50%). The average score of the 7 questions was calculated as the sum of scores divided by the number of questions that were answered by the participants, as long as there were at least 6 questions answered and the missing items were neither question 1 nor question 7.|Week 16|The full analysis set (FAS) for the QGE031 240 mg q2w, placebo to QGE031 240 mg q2w and Omalizumab groups (n=120,49,131) was considered for the analysis. Only participants who had week 16 values were analyzed. The FAS included randomized participants who received at least one dose of study drug.||Percentage of participants|||Number
669028|NCT01716663|Secondary|Total Radiofrequency (RF) Time|Total RF time is defined as the total time RF is delivered during the procedure.|Day 0|Patients with non-missing RF application time.||minutes||Standard Deviation|Mean
669029|NCT01716663|Secondary|Mean Number of Radiofrequency (RF) Applications|RF application is defined as the number of times RF energy is delivered during the procedure.|Day 0|Patients with non-missing RF application values||number of applications||Standard Deviation|Mean
669030|NCT01716663|Secondary|Acute Procedural Success|Acute success will be defined as confirmation of pulmonary vein isolation by entrance block, exit block, and/or periostial block of all targeted pulmonary veins.|Day 0|Acute effectiveness and efficiency cohort||participants|||Number
669031|NCT01716663|Secondary|Total Procedure Time|The procedure time will be measured for each phase (access, mapping, ablation, and validation) of the procedure and summed to derive the total.|Day 0|The number of patients with non-missing procedure time data.||minutes||Standard Deviation|Mean
669032|NCT01716663|Primary|Total Fluoroscopy Time|The fluoroscopy time will be measured for each phase (access, mapping, ablation, and validation) of the procedure and summed to derive the total.|Day 0|Those patients with non-missing fluoroscopy time.||minutes||Standard Deviation|Mean
669033|NCT01716585|Secondary|Percentage of Participants With Virologic Relapse After Treatment: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm|Participants were considered to have virologic relapse after treatment if they had confirmed quantifiable plasma hepatitis C virus ribonucleic acid (HCV RNA) greater than or equal to the lower limit of quantification (≥ LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA < LLOQ at the end of treatment.|Within 12 weeks post-treatment|Intent-to-treat (ITT) Population: All randomized participants who received at least 1 dose of blinded study drug with HCV RNA < LLOQ at the final treatment visit who completed treatment in the Double-blind ABT-450/r/ABT-267 and ABT-333, plus RBV treatment arm.||percentage of participants||95% Confidence Interval|Number
669034|NCT01716585|Secondary|Percentage of Participants With On-treatment Virologic Failure During the Double-blind Treatment Period: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm|Virologic failure was defined as rebound (hepatitis C virus ribonucleic acid [HCV RNA] ≥ lower limit of quantification [LLOQ] after HCV RNA < LLOQ or increase in HCV RNA of at least 1 log10 IU/mL) or failure to suppress (all on-treatment values of plasma HCV RNA ≥ LLOQ with at least 36 days of treatment) during treatment.|12 weeks after the last actual dose of active study drug|Intent-to-treat (ITT) Population: All randomized participants who received at least 1 dose of blinded study drug in the Double-blind ABT-450/r/ABT-267 and ABT-333, plus RBV treatment arm.||percentage of participants||95% Confidence Interval|Number
669035|NCT01716585|Secondary|Percentage of HCV Genotype 1b-infected Participants With Sustained Virologic Response 12 Weeks After Treatment|The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of active study drug|Intent-to-treat (ITT) Population: All randomized participants in the Double-blind ABT-450/r/ABT-267 and ABT-333, plus RBV treatment arm with HCV genotype 1b who received at least 1 dose of blinded study drug.||percentage of participants|||Number
669037|NCT01716585|Secondary|Percentage of Participants With Normalization of Alanine Aminotransferase (ALT) at Final Treatment Visit During the Double-Blind Treatment Period|Normalization is defined as alanine aminotransferase less than or equal to the upper limit of normal (ULN) at final treatment visit for participants with alanine aminotransferase greater than ULN at baseline.|At 12 weeks|Intent-to-treat (ITT) Population: All randomized participants who received at least 1 dose of blinded study drug and had ALT ≥ ULN of the reference range at baseline were included in the analysis.||percentage of participants|||Number
669038|NCT01716585|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment|The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of active study drug|Intent-to-treat (ITT) Population: All randomized participants who received at least 1 dose of blinded study drug.||percentage of participants|||Number
669039|NCT01716559|Secondary|Number of Participants With Adverse Events and Serious Adverse Events|An adverse event (AE) was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Number of participants with at least one AE and SAE were reported.|Up to Week 16|The analysis was performed on total population.||participants|||Number
669040|NCT01716559|Secondary|Number of Participants With or With no Response on Efficacy of Treatment With or Without Iron Replacement Therapy|"Effect of individual iron supplementation on the efficacy of Epoetin beta treatment was described by percentage of participants with or with no response on efficacy of treatment due iron replacement therapy. Response was determined by calculating the difference in Hb level at H3 (Week 8) as compared to H1 (baseline). If H3-H1 is greater than (>) 1, there is a response (response value =1), otherwise there was no response (response value=0). If both were missing, then response was also missing. Response value as 1 denotes an effect on the response of treatment with or without iron replacement therapy. Response value as 0 denotes no effect on the response of treatment with or without iron replacement therapy."|Up to Week 16|The analysis was performed on total population. At the end of the study, data allowing the evaluation of effect of individual iron supplementation on the efficacy of Epoetin beta treatment were available for 103 participants out of total population of 160.||participants|||Number
669041|NCT01716559|Secondary|Percentage of Red Blood Cell Transfusion-free Participants|Percentage of participants who have not received red blood cell (RBC) transfusion (packed RBC or whole blood) during the study were reported.|Up to Week 16|The analysis was performed on Total population.||percentage of participants||95% Confidence Interval|Number
669042|NCT01716559|Secondary|Mean Change From Baseline in Hemoglobin Level up to Week 16|The mean change in Hb concentration was calculated by subtracting the baseline Hb concentration from the Weekly Hb concentration.|Baseline, Week 4, Week 8, Week 12, and Week 16|"The analysis was performed on Total population. The n signifies the number of participants assessed for mean change in hemoglobin level for specified time point."||g/dL||Standard Error|Mean
669043|NCT01716559|Primary|Percentage of Participants With an Increase of Greater Than or Equal to 1 Gram Per Decilitre in Hemoglobin Level at Week 8|Therapeutic response was defined as an increase of greater than or equal to (>=) 1 gram per decilitre (g/dL) in hemoglobin (Hb) level as compared to baseline, following 8 weeks of Epoetin beta treatment. The Therapeutic response rate was summarized as percentage of participants with an increase of >= 1 g/dL in Hb level at Week 8 as compared to baseline.|Baseline to Week 8|The analysis was performed on total population. At the end of the Week 8, data allowing the evaluation of the therapeutic response was available for 103 participants out of total population of 160.||percentage of participants||95% Confidence Interval|Number
669044|NCT01716520|Secondary|Change From Baseline in Trough FEV1 on Day 15 of Each Treatment Period|Trough FEV1 on Treatment Day 15 is defined as the mean of the FEV1 values obtained at 23 and 24 hours after dosing on Day 14. Analysis was performed using an ANCOVA model with covariates of treatment, period, mean Baseline (BL), period BL, response type, and treatment by response type interaction. A participant is a reponder to UMEC if they were a responder to UMEC monotherapy or a responder to both UMEC monotherapy and VI monotherapy. A participant is a responder to VI if they were a responder to VI monotherapy or a responder to both UMEC monotherapy or VI monotherapy. BL is the mean FEV1 recorded 30 min and 5 min pre-dose on Day 1 of each treatment period, mean BL is the mean of the BLs for each participant, and period BL is the difference between BL and the mean BL in each treatment period for each participant. Change from BL for each treatment period is the Day 15 value minus the BL value for that treatment period.|Baseline and Day 15 of each treatment period (up to study day 84)|ITT Population. Only those participants available at the specified time points were analyzed. Different participants may have been analyzed for different parameters; the overall number of participants analyzed reflects everyone in the ITT Population.||Liters||Standard Error|Least Squares Mean
669045|NCT01716520|Secondary|Number of Participants With a Larger Change From Baseline in 0-6 Hour Weighted Mean FEV1 at Day 14 of Each Treatment Period With UMEC/VI Compared With UMEC and VI Alone|The number of participants with a larger change from Baseline in weighted mean FEV1 with UMEC/VI compared with UMEC and VI alone was recorded. Participants who improved on UMEC/VI had a larger change from Baseline difference in 0-6 hour weighted mean FEV1 on Day 14 on UMEC/VI compared to UMEC or VI alone. Baseline is the mean FEV1 values recorded 30 min and 5 min pre-dose on Day 1 of each treatment period, mean Baseline is the mean of the Baselines for each participant, and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Change from Baseline for each treatment period is the Day 14 value minus the Baseline value for that treatment period.|Baseline and Day 14 of each treatment period (up to study day 83)|ITT Population. Only those participants available at the specified time point were analyzed.||participants|||Number
669229|NCT01713530|Primary|Change From Baseline in HbA1c (%)|Change from baseline in HbA1c (%) after 26 weeks of treatment|Week 0, week 26|The FAS included all randomised subjects. The statistical evaluation of the FAS followed the ITT principle and subjects contributed to the evaluation “as randomised”.||percentage change in HbA1c||Standard Error|Least Squares Mean
669046|NCT01716520|Secondary|Number of Participants (Par.) Who Were Responsive to UMEC/VI, UMEC, or VI According to FEV1 at Day 1 of Each Treatment Period (TP)|A responder is a par. with an increase from BL of >=12% and 200 milliliters (mL) at >=1 time point over 0-6 hours post-dose (PD) in FEV1 on Day 1. A non-responder (NR) is a par. with >=1 FEV1 assessment over 0-6 hours PD on Day 1 but no increase from BL of >=12% and 200 mL at any assessment(s). Missing: no FEV1 data recorded over 0-6 hours PD on Day 1. Response type is defined based on a par.’s response to each individual monotherapy treatment. A responder to UMEC is a par. who is a responder in the UMEC treatment period (TP) and either a NR or has missing data in the VI TP. A responder to VI is a par. who is a responder in the VI TP and either a NR or has missing data in the UMEC TP. A responder to UMEC and VI is a par. who is a responder in both the UMEC and VI TPs. A responder to neither is a par. who is a NR in both the UMEC and VI TPs. Missing: a par. who has missing data in both the UMEC and VI TPs, or who has missing data in one monotherapy period and is a NR in the other.|Baseline (BL) and 0-6 hours post-dose (15 minutes, 30 minutes, and 1, 3, and 6 hours post-dose) on Day 1 of each treatment period (up to study day 71)|ITT Population||participants|||Number
669047|NCT01716520|Primary|Change From Baseline (BL) in Weighted Mean (WM) 0-6 Hour Forced Expiratory Volume in One Second (FEV1) Obtained Post-dose at Day 14 of Each Treatment Period (TP) by Response Type|FEV1 is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. The WM FEV1 was derived by calculating the area under the FEV1/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. The WM FEV1 was calculated using 0-6 hour post-dose measurements at Day 14 of each TP, which included pre-dose (trough value for Day 14 [mean of the 23 and 24 hour assessments post Day 13 dosing]) and post-dose 15 minutes (min), 30 min, and 1, 3, and 6 hours. BL is the mean FEV1 values recorded 30 min and 5 min pre-dose on Day 1 of each TP, mean BL is the mean of the BLs for each participant, and period BL is the difference between the BL and the mean BL in each TP for each participant. Change from BL for each TP is the Day 14 value minus the BL value for that TP. Participants could have been classified as responders to both UMEC and VI.|Baseline and Day 14 of each treatment period (up to study day 83)|Intent-to-Treat (ITT) Population: all participants (par.) randomized to treatment who received >=1 dose of randomized study medication in a TP. Only par. available at the specified time points were analyzed. Different par. may have been analyzed for different parameters; the overall number of par, analyzed reflects everyone in the ITT Population.||Liters||Standard Error|Least Squares Mean
669048|NCT01716468|Primary|To Determine the Safety and Tolerability of a Modified Low Carbohydrate Diet in People With Advanced Cancer Across Different Tumor Types.|Recent studies involving human patients with brain cancer showed tolerability of the Ketogenic diet over a period as long as 19 months with minimal side effects. It is hypothesized that the effect this diet will have on overall weight loss, hyperlipidemia, and blood glucose levels will be minimal and tolerable even by cancer patients over a prolonged period of time, up to 12 months or possibly longer. Serum fasting glucose, cholesterol, total, LDL, HDL and triglycerides, serum ketones in mg/dl units , weight in lbs. will be measured at designated time points. Number of patients actually tolerating the diet for at least 4 weeks or more will be recorded.|16 weeks|Solid cancers or blood cancers with measurable components in advanced or metastatic stages.||participants|||Number
669049|NCT01716455|Primary|Maximum Plasma Concentration (Cmax) of SSP-004184|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Over 96 hours post-dose|The Pharmacokinetic Analysis Set is defined as all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data are considered sufficient and interpretable. The Safety Analysis Set consists of all enrolled subjects who take at least 1 dose of investigational product and have at least 1 post dose safety assessment.||ng/ml||Standard Deviation|Mean
669050|NCT01716455|Primary|Area Under the Plasma Concentration-time Curve (AUC) of SSP-004184|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Over 96 hours post-dose|The Pharmacokinetic Analysis Set is defined as all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data are considered sufficient and interpretable. The Safety Analysis Set consists of all enrolled subjects who take at least 1 dose of investigational product and have at least 1 post dose safety assessment.||ng*hr/ml||Standard Deviation|Mean
669051|NCT01716234|Secondary|Number of Participants With an Adverse Event Leading to Study Drug Discontinuation|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of preexisting conditions.|Up to Day 28|The population analyzed was all treated participants.||Participants|||Number
669052|NCT01716234|Secondary|Number of Participants With an Adverse Event|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of preexisting conditions.|Up to Day 58|The population analyzed was all treated participants.||Participants|||Number
669053|NCT01716234|Primary|Average Concentration of Posaconazole (Cavg) on Day 7 (Steady State)|Blood samples for determination of plasma posaconazole concentration were collected predose and approximately 3, 5, 8, and 12 hours after the first dose on Day 7 (steady state). The 12-hour sample was not obtained for the TID dose groups. The target Cavg range was 500 to <2500 ng/mL.|Up to 12 hours after the first dose on Day 7 (BID dose groups) or up to 8 hours after the first dose on Day 7 (TID dose|The pharmacokinetic evaluable population included all treated participants with evaluable samples applicable to the endpoint.||ng/mL||Standard Deviation|Mean
669054|NCT01716234|Primary|Average Concentration of Posaconazole (Cavg) on Day 1 (Single Dose)|Blood samples for determination of plasma posaconazole concentration were collected predose and approximately 3, 5, 8, and 12 hours after the first dose on Day 1. The 12-hour sample was not obtained for the TID dose groups. Day 1 pharmacokinetic samples were not collected for participants 3 months to <2 years of age weighing <6.5 kg.|Up to 12 hours after the first dose (BID dose groups) or up to 8 hours after the first dose (TID dose (TID dose groups)|The pharmacokinetic evaluable population included all treated participants with evaluable samples applicable to the endpoint.||ng/mL||Standard Deviation|Mean
673916|NCT01656850|Primary|Area Under Curve of Plasma Glucose After Eating Standard Breakfast at the Baseline and at the End of 3-month Dietary Intervention||at the baseline and at the end of 3-month dietary intervention|||mg.min/dL||Standard Deviation|Mean
669055|NCT01716221|Other Pre-specified|Hamilton Depression Rating Scale|The Hamilton Depression Rating Scale is a 21 item questionnaire scored each item on a scale of 0 to 3 or 5. The max score is 66. Higher scores indicate worsened depression. All items are summed together to give a total score. A total score of 0-7 is considered normal, while total scores greater than 20 are indicative of moderate or greater depression.|Assessements are performed in 5 different states in a single patient: baseline (Bupropion 100mg and Citalopram 20mg - unblinded), then blinded at 5 weeks (citalopram), 10 weeks (placebo), 15 (bupropion), and 20 weeks (citalopram + bupropion)|||units on a scale|||Number
669056|NCT01716221|Secondary|Comparison of FARS and ICARS|Differences between FARS - ICARS at each treatment interval|Assessements are performed in 5 different states in a single patient: baseline (Bupropion 100mg and Citalopram 20mg - unblinded), then blinded at 5 weeks (citalopram), 10 weeks (placebo), 15 (bupropion), and 20 weeks (citalopram + bupropion)|||points|||Number
669057|NCT01716221|Primary|Friedreich Ataxia Rating Scale (FARS)|A rating scale developed for Friedreich ataxia in evaluation of ataxia. Score range from 0-159 with a score of 0 meaning normal and greater scores indicating worsened disease.|Assessements are performed in 5 different states in a single patient: baseline (Bupropion 100mg and Citalopram 20mg - unblinded), then blinded at 5 weeks (citalopram), 10 weeks (placebo), 15 (bupropion), and 20 weeks (citalopram + bupropion)|||points|||Number
669058|NCT01716221|Primary|International Cooperative Ataxia Rating Scale (ICARS)|The ICARS is a 19 item rating scale of ataxia with the total score ranging from 0 to 100. A score of 0 means normal and higher scores represent worsened disease.|Assessements are performed in 5 different states in a single patient: baseline (Bupropion 100mg and Citalopram 20mg - unblinded), then blinded at 5 weeks (citalopram), 10 weeks (placebo), 15 weeks (bupropion), and 20 weeks (citalopram + bupropion)|||units|||Number
669059|NCT01716169|Primary|Percentage of Wound Surface Area Change From Baseline to Week 8|Change was assessed in terms of wound surface area, as measured using the ARANZ camera. Week 8 surface area measurement was compared to baseline surface area measurement and percentage in size change was calculated.|Baseline and Week 8|||percentage of wound surface area||95% Confidence Interval|Mean
669060|NCT01716156|Secondary|Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After the End of Study Therapy (SVR 24)|HCV RNA was measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay, which has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. SVR24 was defined as HCV RNA <25 IU/mL 24 weeks after the end of all study therapy.|Up to Week 48|Per protocol population, per assigned treatment duration. Per protocol population consists of all randomized participants receiving ≥1 dose of study therapy and no important protocol deviations.||Percentage of participants||95% Confidence Interval|Number
669061|NCT01716156|Secondary|Percentage of Participants With Sustained Virologic Response 4 Weeks After Ending Study Therapy (SVR4)|HCV RNA was measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay, which has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. SVR4 was defined as HCV RNA <25 IU/mL 4 weeks after the end of all study therapy.|Up to Week 28|Per protocol population, per assigned treatment duration. Per protocol population consists of all randomized participants receiving ≥1 dose of study therapy and no important protocol deviations.||Percentage of participants||95% Confidence Interval|Number
669062|NCT01716156|Secondary|Percentage of Participants With HCV RNA <25 IU/mL by Time Point|HCV RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay on blood samples drawn from each participant at Week 2, Week 4, Week 12, and at end of treatment (End of Treatment Response). The assay has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. Undetectable HCV RNA was defined as below the limit of detection of 9.3 IU/mL.|From Week 2 through end of treatment (up to 24 weeks)|Per protocol population, per assigned treatment duration. Per protocol population consists of all randomized participants receiving ≥1 dose of study therapy and no important protocol deviations.||Percentage of participants||95% Confidence Interval|Number
669063|NCT01716156|Secondary|Percentage of Participants With Undetectable HCV RNA by Time Point|HCV RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay on blood samples drawn from each participant at Week 2, Week 4, Week 12, and at end of treatment (End of Treatment Response). The assay has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. Undetectable HCV RNA was defined as below the limit of detection of 9.3 IU/mL.|From Week 2 through end of treatment (up to 24 weeks)|Per protocol population, per assigned treatment duration. Per protocol population consists of all randomized participants receiving ≥1 dose of study therapy and no important protocol deviations.||Percentage of participants||95% Confidence Interval|Number
669064|NCT01716156|Secondary|Time to Achievement of First Undetectable HCV RNA|The mean time (in days) to first achievement of undetectable HCV RNA was assessed using Kaplan-Meier plot and summary statistics. HCV RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay on blood samples drawn from each participant at Week 2, Week 4, Week 12, and at end of treatment. The assay has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. Undetectable HCV RNA was defined as below the limit of detection of 9.3 IU/mL.|Up to Week 24|Full analysis set consists of all randomized participants receiving ≥1 dose of study therapy.||Days||Standard Error|Mean
669065|NCT01716156|Primary|Percentage of Participants Discontinuing Study Therapy Due to an AE|An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an adverse event. Data are presented according to actual treatment duration (12 weeks or 24 weeks) regardless of participants' initial arm assignment.|Up to 24 weeks|The APaT population included all randomized participants who received at least 1 dose of study therapy.||Percentage of participants|||Number
669230|NCT01713400|Secondary|Incidence of Acute Graft vs. Host Disease (AGVHD)|Cumulative incidence of Grade II – IV AGVHD to be characterized weekly from day of transplant to day 100 using the 1995 updated grading scheme for Graft vs. Host Disease (GVHD) developed by Glucksberg, et al.|100 days post transplant|All participating recipients||percentage of participants|||Number
669066|NCT01716156|Primary|Percentage of Participants Experiencing at Least One Adverse Event (AE) on Study|An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an adverse event. Data are presented according to actual treatment duration (12 weeks or 24 weeks) regardless of participants' initial arm assignment.|Fourteen days following last dose of study drug (up to 26 weeks)|The All Participants as Treated (APaT) population included all randomized participants who received at least 1 dose of study therapy.||Percentage of participants|||Number
669067|NCT01716156|Primary|Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After the End of All Study Therapy (SVR12)|SVR12 was defined as HCV RNA <25 IU/mL 12 weeks after the end of all study therapy. HCV RNA was measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay, which has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL.|Up to Week 36|Per protocol population, as randomized. Per protocol population consists of all randomized participants receiving ≥1 dose of study therapy and no important protocol deviations.||Percentage of participants||95% Confidence Interval|Number
669068|NCT01716052|Primary|Measure of Discomfort of Mammography|The primary outcome measure will be the response to questions on a questionnaire.|3 years|No data was collected or analyzed for the outcome measure because the study was terminated.|||||
669069|NCT01716013|Other Pre-specified|Wound Dehiscence Requiring Treatment|Wound dehiscence requiring treatment; i.e., need for supplemental closure due to dehiscence at any time, from closure through follow-up|28 Days and 90 days|Intent-to-Treat (ITT) population||percentage of participants|||Number
669070|NCT01716013|Secondary|≥ 50% Wound Apposition at 10 Days|Incidence of wounds ≥50% apposed (10 ± 3 days)|10 days|Intent-to-treat (ITT) population||percentage of participants|||Number
669071|NCT01716013|Secondary|Optimal Cosmetic Outcome at 28 Days (Score of 6)|"Incidence of wounds with an optimal cosmetic outcome (score of 6) at 28 days.
One point was scored for the absence of, and no point was scored for the presence of, any of the following six items:
Stepoff of borders (edges not on the same plane)
Contour irregularities (wrinkled skin near wound)
Margin separation (gap between sides)
Edge inversion (wound not properly everted)
Excessive distortion (swelling or edema or infection)
Poor overall appearance.
The overall cosmesis score was determined by adding the scores of each individual item. An overall score of six was considered an optimal score outcome. Any score below six was considered suboptimal."|28 days|Intent-to-treat (ITT) population||percentage of participants|||Number
669072|NCT01716013|Primary|100% Wound Apposition at 10 Days|Percentage of subjects in whom 100% wound edge apposition is achieved at 10 days (±3 days) post-procedure.|10 days|Per protocol population (primary analysis dataset)||percentage of participants|||Number
669073|NCT01715948|Primary|Speech Spatial Qualities Questionnaire (SSQ)|"The Speech Spatial Qualities Questionnaire (SSQ) was given to assess the self-perceived benefits provided by the device that was worn the previous 2 weeks. The SSQ requires participants to rate their perceived hearing ability for 49 scenarios using a 10-point scale, ranging from 0 (Not at all) to 10 (Perfectly). A score higher than 0 for each listening scenario shows some benefit of the device, while a score of 10 indicates the device was extremely beneficial. Therefore, a lower score indicated poorer self-perceived benefit from the device (representing a worse outcome), while a higher score indicated greater self-perceived benefit from the device (representing a better outcome). To obtain individual scores for the SSQ questionnaire, the ratings for each listening scenario were summed. The mean, minimum and maximum scores for each subscale of the SSQ across all participants were also determined."|Administered at the end of a 2 week trial with the CROS and at the end of a 2 week use of the BAHD.|||units on a scale||95% Confidence Interval|Mean
669074|NCT01715948|Primary|Percentage of Words Recognized|Word recognition was tested with the recorded version of the Central Institute for the Deaf (CID) W-22 (Auditec of St. Louis), with a different list of 25 monosyllabic words presented at 50 dB HL in three randomized listening conditions. In the first condition, one list was presented at 50 dB HL at 90 degrees to the poor ear in quiet. In the second condition, the words were presented at 50 dB HL at 0 degrees while multitalker noise was presented at 45 dB HL at 90 degrees to the poor ear. In the final condition, the words were presented at 50 dB HL at 0 degrees while multitalker noise was delivered at 45 dB HL at 90 degrees to the better ear.|Word recognition testing (unaided) occurred at baseline, an average of 2 weeks (with CROS or BAHD) and an average of 4 weeks (with opposite device not previously tested)..|The researchers chose not to include a condition with words presented at 90 degrees to the better ear in quiet.||Percentage of words perceived correctly||95% Confidence Interval|Mean
669075|NCT01715948|Primary|Number of 5 Key Words Within 6 Sentence Lists Repeated Correctly in the Presence of Multitalker Noise|One speech-in-noise test (QuickSIN) presented four lists of six pre-recorded sentences at 50 dB hearing level (HL) in soundfield. Multitalker noise was presented together with the target sentence and increased at a fixed number of dB with the completion of each sentence. The multitalker noise was initially presented at 25 dB HL (signal-to-noise ratio - SNR of 25 dB), and increased by 5 dB after each sentence until the multitalker noise was of equal intensity with the final sentence (SNR of 0 dB). In one condition, two lists of sentences were presented to the participant at 0 degrees with the multitalker noise delivered at 90 degrees to the poor ear. In the other condition, two different lists of sentences were presented to the participant at 0 degrees with the multitalker noise delivered at 90 degrees to the better ear. The two scores derived from the two different lists of sentences presented within each condition were averaged. A low score indicates better performance.|The QuickSIN unaided was administered at baseline, an average of 2 weeks (with CROS or BAHD) and an average of 4 weeks (with opposite device not previously tested).|||words||95% Confidence Interval|Mean
669076|NCT01715896|Secondary|Number of Participants Exhibiting Anti-Drug Antibodies (ADAs) to Mavrilimumab|Immunogenicity assessment included determination of anti-drug (mavrilimumab) antibodies in serum samples. ADA detection measured by using electrochemiluminescence assays.|Day 1 to Day 169|The immunogenicity population included all participants who received at least 1 dose of mavrilimumab and for whom at least one serum sample for immunogenicity testing was available.||participants|||Number
669077|NCT01715896|Secondary|Serum Concentrations of Mavrilimumab|Serum concentrations after subcutaneous dose of mavrilimumab were calculated|Baseline, Day 8, 15, 29, 85, 141, and 169|"The pharmacokinetic (PK) population included all participants who received mavrilimumab and for whom serum concentrations of mavrilimumab were available for PK data analyses. Here n signifies participants who were evaluable for the specified time point for each this arm respectively."||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
669078|NCT01715896|Secondary|Erythrocyte Sedimentation Rate (ESR) at Day 169|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. The farther the red blood cells have descended, the greater the inflammatory response.|Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here N (Number of participants analyzed) signifies those participants who were evaluable for this measure. n'' signifies participants evaluable for specified category for each arm, respectively."||millimeter per hour (mm/h)||Standard Deviation|Geometric Mean
669079|NCT01715896|Secondary|Ratio of Change C-Reactive Protein (CRP) at Day 169 to Baseline|The ratio of change from baseline for CRP was analyzed and reported. The CRP is a substance produced by the liver that increases in the presence of inflammation in the body. The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement in underlying disease.|Baseline and Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here N (Number of participants analyzed) signifies those participants who were evaluable for this measure."||ratio||Geometric Coefficient of Variation|Geometric Mean
669080|NCT01715896|Secondary|Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Day 169|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item was scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range from 0 to 3; where 0 = least difficulty and 3 = extreme difficulty.|Baseline and Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||units on a scale||Standard Error|Mean
669081|NCT01715896|Secondary|Mean Change From Baseline in Physician Global Assessment of Disease Activity (MDGA) at Day 169|Physician Global Assessment of Arthritis was measured by asking the physician to assess the participant's current arthritis disease activity by placing a vertical line on a 0 to 10 cm VAS, where 0 cm = very good and 10 cm = very bad.|Baseline and Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||centimeter (cm)||Standard Error|Mean
669082|NCT01715896|Secondary|Mean Change From Baseline in Patient Global Assessment (PGA) of Disease Activity at Day 169|"Participants responded to a question, Considering all the ways your arthritis affects you, how are you feeling today? by using a 0 - 100 mm VAS, where 0 = very well and 100 = very poorly."|Baseline and Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||mm||Standard Error|Mean
669083|NCT01715896|Secondary|Mean Change From Baseline in Patient Assessment of Pain at Day 169|Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.|Baseline and Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||millimeter (mm)||Standard Error|Mean
669084|NCT01715896|Secondary|Mean Change From Baseline in Swollen and Tender Joint Count at Day 169|Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form, no swelling = 0, swelling =1. Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form, no tenderness = 0, tenderness = 1. Mean here indicates adjusted mean.|Baseline and Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||joint count||Standard Error|Mean
669085|NCT01715896|Secondary|Percentage of Participants With American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Remission at Day 169|The ACR/EULAR remission was defined as swollen joint count (0-66), tender joint count (0-68), CRP (mg/dL) and participant global assessment (0-10) all less than or equal to one.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.||percentage of participants|||Number
669086|NCT01715896|Secondary|Percentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Day 169|The CDAI was the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, patient global assessment and physician global assessment assessed on 0 - 10 cm VAS. The CDAI total score ranges from 0 to 76 where higher scores indicates greater affection due to disease activity. CDAI remission was defined as a score less than or equal to 2.8.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.||percentage of participants|||Number
669169|NCT01714635|Secondary|Spectacle Independence|Number of subjects never requiring spectacles at six months. This outcome measure was obtained via questionnaire. The questionnaire was administered by phone.|six months|Five subjects (3 from Group #1 [145-142], 1 from Group #2 [150-149], and 1 from the monofocal control group [146-145]) did not complete the questionnaire because they were unavailable, refused to complete it, implant status precluded completion (bilateral implants required), or failed to answer this particular question.||participants|||Number
669087|NCT01715896|Secondary|Percentage of Participants Who Achieved Simplified Disease Activity Index (SDAI) Remission at Day 169|The SDAI was the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, patient global assessment and physician global assessment assessed on 0 - 10 centimetre (cm) VAS; and C-reactive protein (CRP) (milligram per deciliter [mg/dL]). The SDAI total score ranges from 0 to 86, where higher scores indicates greater affection due to disease activity. SDAI remission was defined as a score less than or equal to 3.3. The percentage of participants were calculated by logistic regression model method.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.||percentage of participants|||Number
669088|NCT01715896|Secondary|Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using Erythrocyte Sedimentation Rate (DAS28 [ESR]) < 2.6 at Day 169|The DAS28 (ESR) calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]). Total score range: 0-9.4, higher score = more disease activity. DAS28 (ESR) <3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission. The percentage of participants were calculated by logistic regression model method.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.||percentage of participants|||Number
669089|NCT01715896|Secondary|Duration of DAS28 (CRP) Remission at Day 169|The DAS28 (CRP) was calculated from the number of SJC and TJC using the 28 joints count, The DAS28(CRP) considers 28 of the 68 TJC and 28 of the 66 SJC and participant's global health (GH) using PGA of disease activity using the VAS of 0 (= best), 100 (= worst) plus levels of CRP (mg/L). Total score range: 0-9.4, higher score= more disease activity. DAS28 (CRP) <3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission. Participants with score less than 2.6 were analysed. Duration of DAS28(CRP) remission for each subject was defined as number of days from onset of remission to when the subject was no longer in remission.|Day 169|"The mITT population analysis set included all participants who were at risk in the treatment group corresponding to their randomized treatment group. Here, N is number of participants analysed for this outcome measure."||days||Standard Error|Mean
669090|NCT01715896|Secondary|Time to Onset DAS28 (CRP) Remission at Day 169|The DAS28 (CRP) was calculated from the number of SJC and TJC using the 28 joints count, The DAS28(CRP) considers 28 of the 68 TJC and 28 of the 66 SJC and participant's global health (GH) using PGA of disease activity using the VAS of 0 (= best), 100 (= worst) plus levels of CRP (mg/L). Total score range: 0-9.4, higher score= more disease activity. DAS28 (CRP) <3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission. Participants with score less than 2.6 were analysed. Onset of DAS28(CRP) remission ≤ 2.6 defined as the first study day in which the DAS28 score met the criteria.|Day 169|"The mITT population analysis set included all participants who were at risk in the treatment group corresponding to their randomized treatment group. Here, N is number of participants analysed for this outcome measure."||days||90% Confidence Interval|Median
669091|NCT01715896|Secondary|Number of Participants With DAS28 (CRP) Remission and Low Disease Activity at Day 169|DAS28 (CRP) calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and CRP (mg/L). Total score range: 0-9.4, higher score= more disease activity. Remission was defined as less than 2.6 DAS28 (CRP) score. Low disease activity was defined as less than 3.2 DAS28 (CRP) score.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.||participants|||Number
669092|NCT01715896|Secondary|Number of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 169|DAS28 (CRP) response by EULAR category were used to measure individual response as none, moderate, and good, depending on the extent of change from baseline and the level of disease activity reached. Good response: change from baseline >1.2 with baseline DAS28 (CRP) <3.2; moderate response: change from baseline >1.2 with baseline DAS28 (CRP) >=3.2 to less than or equal to (=<) 5.1 or change from baseline >=0.6 to =< 1.2 with baseline DAS28 (CRP) >=3.2 to =<5.1; no response: change from baseline <0.6 or change from baseline >=0.6 and =<1.2 with baseline DAS28 (CRP) >5.1.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.||participants|||Number
669093|NCT01715896|Secondary|American College of Rheumatology (ACR) Hybrid Score at Day 169|ACR Hybrid score was defined as the minimum of the percentage improvement in TJC, SJC and the median of the percentage improvements in the other five components of the ACR criteria (participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; disability index of the HAQ; and CRP). Total score range was -100 to 100, where negative numbers indicated worsening and positive numbers indicated improvement.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.||units on a scale||Full Range|Median
669094|NCT01715896|Secondary|Change From Baseline in Continuous American College of Rheumatology (ACRn) Score at Day 169|ACR score - continuous (ACRn) was defined as the minimum of the percentage improvement in TJC, SJC and the median of the percentage improvements in the other five components of the ACR criteria (participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; disability index of the HAQ; and CRP). Total score range was -100 to 100, where negative numbers indicated worsening and positive numbers indicated improvement. Mean indicates adjusted mean (Adj mean).|Baseline up to Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||units on a scale||Standard Error|Mean
669103|NCT01715896|Primary|Percentage of Participants Who Achieved American College of Rheumatology 70 (ACR70) Responses at Day 169|The ACR70 was defined as >=70% improvement, in: SJC and TJC and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP. If CRP was missing and ESR was present then ESR was to be used. The percentage of participants were calculated by logistic regression model method.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.||percentage of participants|||Number
669095|NCT01715896|Secondary|Change From Baseline in Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Score at Day 169|DAS28 (CRP) calculated swollen joint count (SJC) and tender joint count (TJC) using the 28 joints, general health (GH) using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and CRP (milligram per liter [mg/L]). Total score range: 0-9.4, higher score= more disease activity. DAS28 (CRP) less than (<) 3.2 = low disease activity, greater than or equal to (>=) 3.2 to 5.1 = moderate to high disease activity and <2.6= remission.|Baseline and Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively"||units on a scale||Standard Deviation|Mean
669096|NCT01715896|Secondary|Dyspnea Score at Day 169|Borg dyspnea scale was a validated participant reported outcome assessing participant’s perceived difficulty in breathing (dyspnea). The scale ranges from 0 (nothing at all) to 10 (maximal difficulty). Higher scores indicated greater difficulty in breathing.|Day 169|"The safety population included all participants who received any amount of investigational product. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||units on a scale||Standard Deviation|Mean
669097|NCT01715896|Secondary|Number of Participants With Pulmonary Function Test Values Below Threshold Values Based on Percent Change From Baseline at Day 85 and 169|Pulmonary function testing were performed by spirometry to assess forced expiratory volume in 1 second (FEV1), forced expiratory volume in 6 second (FEV6), forced vital capacity (FVC), and diffusing capacity for carbon monoxide (DLCO). FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FEV6 was the maximal volume of air exhaled in the six second of a forced expiration from a position of full inspiration. FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. DLCO is a pulmonary function test that measures the partial pressure difference between inspired and expired carbon monoxide. The percentage of predicted values of these pulmonary function tests were calculated based on decreases from baseline and categorized as more than (>) 20% reduction (RD) and absolute value (AV) less than (<) 80% predicted (PR).|Day 85 and 169|"The safety population included all participants who received any amount of investigational product. Here n signifies participants who were evaluable for this measure for the specified threshold value mentioned parameter for each arm, respectively."||participants|||Number
669098|NCT01715896|Secondary|Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)|Vital sign assessments included blood pressure, pulse rate, temperature, weight and respiration rate. Vital signs abnormalities reported as TEAEs were reported.|Baseline up to Day 169|The safety population included all participants who received any amount of study medication.||participants|||Number
669099|NCT01715896|Secondary|Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)|Any medically significant change in laboratory evaluations were recorded as adverse events. Following parameters were analyzed for laboratory examination: hematology (leukocytosis, neutropenia, anaemia of chronic disease); serum chemistry (alanine aminotransferase, blood parathyroid hormone, gamma glutamyl transferase, hepatic enzyme, dyslipidaemia, hypercholesterolaemia, hyperglycaemia, hyperlipidaemia, hypertriglyceridaemia); urinalysis.|Baseline up to Day 169|The safety population included all participants who received any amount of investigational product.||participants|||Number
669100|NCT01715896|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and Day 169 that were absent before treatment or that worsened relative to pre-treatment state. TEAE and TESAE were reported as per relatedness and severity.|Baseline up to Day 169|The safety population included all participants who received any amount of study medication.||participants|||Number
669101|NCT01715896|Primary|Percentage of Participants Who Achieved Health Assessment Questionnaire Disability Index (HAQ-DI) Score Improvement From Baseline and >= 0.25 at Day 169|The HAQ-DI: 20-item scale assessing participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arising, eating, hygiene, walking, reaching, grip, and errands/chores over past week. Each item was scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range from 0 to 3; where 0 = least difficulty and 3 = extreme difficulty. Participants with change from baseline more than or equal to (>=) 0.25 were reported. The percentage of participants were calculated by logistic regression model method.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.||percentage of participants|||Number
669102|NCT01715896|Primary|Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Response at Day 169|The DAS28 (CRP) was calculated from the number of SJC and TJC using the 28 joints count, The DAS28(CRP) considers 28 of the 68 TJC and 28 of the 66 SJC and participant's global health (GH) using PGA of disease activity using the visual analogue scale (VAS) of 0 (= best), 100 (= worst) plus levels of CRP (milligram/Liter [mg/L]). Total score range: 0-9.4, higher score= more disease activity. DAS28 (CRP) less than (<) 3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission. Participants with score less than 2.6 were analysed. The percentage of participants were calculated by logistic regression model method.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.||percentage of participants|||Number
669117|NCT01715831|Secondary|Participant's Pain Assessment Using VAS Score|"Participant’s pain assessment was made on a horizontal 0-100 mm VAS, with 0 mm (left end of the line) described as no pain and 100 mm (right end of the line) as unbearable pain. The participant marked the line according to their assessment and the distance from the left edge was measured."|Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, and FU Visit 1 (Week 108), FU Visit 2 (Week 116)|ITT population. Here, n=Number of participants analyzed for this outcome measure at specified timepoint.||mm||Standard Deviation|Mean
669104|NCT01715896|Primary|Percentage of Participants Who Achieved American College of Rheumatology 50 (ACR50) Responses at Day 169|The ACR50 was defined as >=50% improvement, in: SJC and TJC and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP. If CRP was missing and ESR was present then ESR was to be used. The percentage of participants were calculated by logistic regression model method.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.||percentage of participants|||Number
669105|NCT01715896|Primary|Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20) Responses at Day 169|The ACR20 was defined as greater than or equal to (>=) 20 percent (%) improvement, in: swollen joint count (SJC) and tender joint count (TJC) and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity (PGA); physician global assessment of disease activity (MDGA); self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-reactive protein (CRP). If CRP was missing and Erythrocyte sedimentation rate (ESR) was present then ESR was to be used.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.||percentage of participants|||Number
669106|NCT01715857|Secondary|Non-compliance of Sevoflurane Vaporizer Setting Following the Consensus|Non-compliance of sevoflurane vaporizer setting was defined as the percentage of time points for the maintenance period outside the range of 1.0 – 1.5 minimal alveolar concentration (MAC) during the maintenance period (excluding washout phase) based on the Consensus. A higher percentage indicates a higher degree of non-compliance.|During maintenance (up to 5 hours)|All participants who received study drug and with available data.||percentage of timepoints|Participants||Number
669107|NCT01715857|Secondary|Non-compliance of Sevoflurane End Tidal Concentration Following the Consensus|Non-compliance of sevoflurane end tidal concentration was defined as the percentage of time points for the maintenance period (excluding washout phase) that were below the sevoflurane end tidal concentration boundary of 0.6 minimal alveolar concentration (MAC) based on the Consensus. A higher percentage indicates a higher degree of non-compliance.|During maintenance (up to 5 hours)|All participants who received study drug and with available data.||percentage of timepoints|Participants||Number
669108|NCT01715857|Secondary|Cost of Anesthetics Including Sevoflurane (Yuan Renminbi [RMB]/Hour)|Cost of anesthetics is the sum of the cost of sevoflurane and other anesthetics including narcotics and muscle relaxants. Cost of sevoflurane = unit price of sevoflurane multiplied by the used volume of sevoflurane. Cost of other anesthetics = unit price of anesthetics multiplied by the total volume of anesthetics in the ampoule.|Anesthetic duration between 1 to 5 hours|All participants who received study drug and with available data.||Yuan renminbi [RMB]/hour||Standard Deviation|Mean
669109|NCT01715857|Secondary|Time to Extubation|Time to extubation was measured from the time sevoflurane administration had stopped until tracheal extubation or laryngeal mask airway (LMA) removal occurred.|From cessation of sevoflurane administration until tracheal extubation occurred, up to 80 minutes|All participants who received study drug and with available data.||minutes||Standard Deviation|Mean
669110|NCT01715857|Secondary|Time to Eye Opening|After cessation of anesthesia, the investigators lightly tapped on the participant’s forehead or shoulder and asked the participant to open their eyes. This process was repeated approximately every minute until eye opening occurred.|From cessation of sevoflurane administration until the participant opened their eyes, up to 80 minutes|All participants who received study drug and with available data.||minutes||Standard Deviation|Mean
669111|NCT01715857|Primary|Participant Satisfaction With the Anesthesia Using a Numeric Analog Scale (NAS)|Participant satisfaction with the anesthesia recorded approximately 24 hours after the end of the operation using a NAS from 0 (not satisfied at all) to 10 (completely satisfied).|24 hours after end of surgery|All participants who received study drug and with available data.||scores on a scale||Standard Deviation|Mean
669112|NCT01715857|Primary|Anesthesiologist Satisfaction With the Anesthesia Using a Numeric Analog Scale (NAS)|Anesthesiologist satisfaction with the anesthesia was recorded by the anesthesiologist at the end of the operation using a NAS from 0 (not satisfied at all) to 10 (completely satisfied). The satisfaction of induction, maintenance, and emergence accounts for 20%, 50%, and 30% of the score, respectively.|End of surgery|||scores on a scale||Standard Deviation|Mean
669113|NCT01715831|Secondary|ESR Level|ESR is an acute phase reactant and is a measure of inflammation.|Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, and FU Visit 1 (Week 108), FU Visit 2 (Week 116)|ITT population. Here, n=Number of participants analyzed for this outcome measure at specified timepoint.||mm/hr||Standard Deviation|Mean
669114|NCT01715831|Secondary|C-Reactive Protein (CRP) Level|CRP is an acute phase reactant and is a measure of inflammation.|Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, and FU Visit 1 (Week 108), FU Visit 2 (Week 116)|ITT population. Here, n=Number of participants analyzed for this outcome measure at specified timepoint.||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
669115|NCT01715831|Secondary|Health Assessment Questionnaire (HAQ) Pain VAS Score|The HAQ pain VAS is a measure of pain on a continuous 100 mm scale. Participants were asked to indicate how much pain they had in the past week as a result of their illness on a horizontal line from 0 (no pain) to 100 mm (severe pain).|Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, and FU Visit 1 (Week 108), FU Visit 2 (Week 116)|ITT population. Here, n=Number of participants analyzed for this outcome measure at specified timepoint.||mm||Standard Deviation|Mean
669116|NCT01715831|Secondary|Health Assessment Questionnaire - Disability Index (HAQ-DI) Score|The Stanford HAQ-DI is a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/personal care, ability to stand-up, eating, walking, hygiene, reaching, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where 0 represents ‘no disability’ and 3 represents ‘very severe, high-dependency disability’.|Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, and FU Visit 1 (Week 108), FU Visit 2 (Week 116)|ITT population. Here, n=Number of participants analyzed for this outcome measure at specified timepoint.||units on a scale||Standard Deviation|Mean
669118|NCT01715831|Secondary|Global Evaluation of Disease Activity by the Physician Using VAS Score|Physician global assessment of disease activity was measured on a horizontal 0-100 mm VAS, with 0 mm (left end of the line) described as “inactive disease” (free of symptoms and without symptoms of arthritis) and 100 mm (right end of the line) as “disease maximum activity” (maximum activity of arthritis). The physician marked the line according to their assessment and the distance from the left edge was measured.|Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, and FU Visit 1 (Week 108), FU Visit 2 (Week 116)|ITT population. Here, n=Number of participants analyzed for this outcome measure at specified timepoint.||mm||Standard Deviation|Mean
669119|NCT01715831|Secondary|Global Evaluation of Disease Activity by the Participant Using VAS Score|Participant’s global assessment of disease activity was measured on a horizontal 0-100 mm VAS, with 0 mm (left end of the line) described as “inactive disease” (free of symptoms and without symptoms of arthritis) and 100 mm (right end of the line) as “disease maximum activity” (maximum activity of arthritis). The participant marked the line according to their assessment and the distance from the left edge was measured.|Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, and FU Visit 1 (Week 108), FU Visit 2 (Week 116)|ITT population. Here, n=Number of participants analyzed for this outcome measure at specified timepoint.||mm||Standard Deviation|Mean
669120|NCT01715831|Secondary|Swollen Joint Count (SJC)|An assessment of 28 joints was conducted for swelling. Joints were assessed and classified as swollen/not swollen by pressure and joint manipulation after a physical examination. Artificial joints, arthrodesis or fused joints were not taken into consideration for swelling.|Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, and FU Visit 1 (Week 108), FU Visit 2 (Week 116)|ITT population. Here, n=Number of participants analyzed for this outcome measure at specified timepoint.||swollen joints||Standard Deviation|Mean
669121|NCT01715831|Secondary|Tender Joint Count (TJC)|An assessment of 28 joints was conducted for tenderness. Joints were assessed and classified as tender/not tender by pressure and joint manipulation after a physical examination. Artificial joints, arthrodesis or fused joints were not taken into consideration for tenderness.|Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, and FU Visit 1 (Week 108), FU Visit 2 (Week 116)|ITT population. Here, n=Number of participants analyzed for this outcome measure at specified timepoint.||tender joints||Standard Deviation|Mean
669122|NCT01715831|Secondary|Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR)|DAS28 score is a measure of participant's disease activity calculated using tender joint count in 28 joints (TJC28), swollen joint count in 28 joints (SJC28), participant's global assessment of disease activity (general health [GH]) using visual analog scale (VAS), 0 millimeter (mm)=no disease activity to 100 mm=maximum disease activity, displayed on the 100 mm horizontal VAS, and acute phase response (erythrocyte sedimentation rate [ESR] in millimeters per hour [mm/hr]) for a total possible score of 0 to 10. The score is calculated using the following formula: DAS28 = [0.56 multiplied by (*) square root (√) of TJC28] plus (+) [0.28*√SJC28]+[0.70*the natural logarithm (ln) ESR]+[0.014*GH]. DAS28-ESR score varies from 0 to 10, where higher scores represent greater disease activity.|Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, and follow-up (FU) Visit 1 (Week 108), FU Visit 2 (Week 116)|ITT population. Here, n=Number of participants analyzed for this outcome measure at specified timepoint.||units on a scale||Standard Deviation|Mean
669123|NCT01715831|Primary|Number of Participants With AEs of Special Interest|Adverse events of special interest included following events: Infections (including opportunistic infections); myocardial infarction / acute coronary syndrome; gastrointestinal (GI) perforations and related events; malignancies; anaphylaxis/hypersensitivity reactions; demyelinating disorders; stroke; hemorrhagic events; and hepatic events. Overall number of participants who experienced any of these AEs of special interest was reported.|From Baseline up to approximately 2 years|ITT population||participants|||Number
669124|NCT01715831|Primary|Number of Participants With AEs Leading to Dose Modification or Study Discontinuation||From Baseline up to approximately 2 years|ITT population||participants|||Number
669125|NCT01715831|Primary|Number of Participants With Serious Adverse Events (SAEs) and Non-Serious Adverse Events (NSAEs)|An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; significant medical event, according to the investigator discretion (e.g., may represent a risk to the participant or may require medical/surgical intervention to prevent one of the outcomes mentioned above).|From Baseline up to approximately 2 years|ITT population||participants|||Number
669126|NCT01715415|Secondary|Percentage of Participants With Virologic Relapse After Treatment: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm|Participants were considered to have virologic relapse after treatment if they had confirmed quantifiable plasma hepatitis C virus ribonucleic acid (HCV RNA) greater than or equal to the lower limit of quantification (≥ LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA < LLOQ at the end of treatment.|Within 12 weeks post-treatment|Intent-to-treat (ITT) Population: All randomized participants who received at least 1 dose of blinded study drug with HCV RNA < LLOQ at the final treatment visit who completed treatment in the Double-blind ABT-450/r/ABT-267 and ABT-333, plus RBV treatment arm.||percentage of participants||95% Confidence Interval|Number
669127|NCT01715415|Secondary|Percentage of Participants With On-treatment Virologic Failure During the Double-blind Treatment Period: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm|Virologic failure was defined as rebound (hepatitis C virus ribonucleic acid [HCV RNA] ≥ lower limit of quantification [LLOQ] after HCV RNA < LLOQ or increase in HCV RNA of at least 1 log10 IU/mL) or failure to suppress (all on-treatment values of plasma HCV RNA ≥ LLOQ with at least 36 days of treatment) during treatment.|12 weeks after the last actual dose of active study drug|Intent-to-treat (ITT) Population: All randomized participants who received at least 1 dose of blinded study drug in the Double-blind ABT-450/r/ABT-267 and ABT-333, plus RBV treatment arm.||percentage of participants||95% Confidence Interval|Number
669164|NCT01715064|Secondary|Exercise-Induced Feelings Inventory - Questionnaire (EIFI)|Correlations will be assessed between cortical silent period and exercise-induced feelings.|10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').||||||
669165|NCT01715064|Secondary|Hospital Anxiety and Depression Scale - Questionnaire(HADS)|Correlations will be assessed between cortical silent period and acute anxiety and depression.|10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').||||||
669128|NCT01715415|Secondary|Percentage of HCV Genotype 1b-infected Participants With Sustained Virologic Response 12 Weeks After Treatment|The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of active study drug|Intent-to-treat (ITT) Population: All randomized participants in the Double-blind ABT-450/r/ABT-267 and ABT-333, plus RBV treatment arm with HCV genotype 1b who received at least 1 dose of blinded study drug. 1 participant, who had genotype 1 HCV with an indeterminate subgenotype, is not included in this analysis.||percentage of participants|||Number
669129|NCT01715415|Secondary|Percentage of HCV Genotype 1a-infected Participants With Sustained Virologic Response 12 Weeks After Treatment|The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of active study drug|Intent-to-treat (ITT) Population: All randomized participants in the Double-blind ABT-450/r/ABT-267 and ABT-333, plus RBV treatment arm with HCV genotype 1a who received at least 1 dose of blinded study drug. 1 participant, who had genotype 1 HCV with an indeterminate subgenotype, is not included in this analysis.||percentage of participants|||Number
669130|NCT01715415|Secondary|Percentage of Participants With Normalization of Alanine Aminotransferase (ALT) at Final Treatment Visit During the Double-Blind Treatment Period|Normalization is defined as alanine aminotransferase less than or equal to the upper limit of normal (ULN) at final treatment visit for participants with alanine aminotransferase greater than ULN at baseline.|At 12 weeks|Intent-to-treat (ITT) Population: All randomized participants who received at least 1 dose of blinded study drug and had ALT ≥ ULN of the reference range at baseline were included in the analysis.||percentage of participants|||Number
669131|NCT01715415|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment|The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of active study drug|Intent-to-treat (ITT) Population: All randomized participants who received at least 1 dose of blinded study drug.||percentage of participants|||Number
669132|NCT01715298|Secondary|Change From Baseline in Morning and Nighttime Symptom Scores|Patients are reporting morning and nighttime symptoms by using an electronic diary. The electronic diary has 9 symptom questions each morning and each evening. Each question can be answered with one of four pre-defined answers, corresponding to a unit value of 0-3, where 0 stands for the lowest and 3 for the most severe symptom experience. Morning and nighttime symptoms scores for each patient over 12 weeks are reported and analyzed. Symptom scores are calculated as the mean of the symptom scores (morning symptom scores or nighttime symptom scores, respectively) for each patient over 12 weeks (Day 1 to week 12). The baseline is calculated from the run-in epoch prior to randomization. The outcome is calculated as the change from baseline in the morning and nighttime symptom scores, respectively. A negative number indicates a reduction in the symptom severity and is owed to the calculation of the change from baseline.|Day 1 to week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization||Score||Standard Error|Least Squares Mean
669133|NCT01715298|Secondary|Change From Baseline in Mean Trough Forced Vital Capacity|Mean trough Forced Vital Capacity (FVC) is assessed as the arithmetic mean of two FVC measurements, conducted within the last hour of a 24 hours period from a morning dose, either that of day 1 or at week 12 of treatment (23:15 h and 23:45 h assessments). The endpoints are the change from baseline in trough FVC on Day 1 and at Week 12, with the mean of the -45 min and -15 min measurements on Day 1 as the baseline.|Day 1 and week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization||Liters||Standard Error|Least Squares Mean
669134|NCT01715298|Secondary|Change From Baseline in Forced Vital Capacity at All Individual Timepoints|The Forced Vital Capacity (FVC)assessments for all individual time points of the serial measurements on day 1 and at week 12 are analyzed. Serial lung function measurements are taken at the following time points following dosing on Day 1 and at week 12: 5 min, 15 min, 1:00 h, 2:00 h, 4:00 h, 6:00 h, 8:00 h, and 11:55 h after the morning dose. For week 12 (day 85), the pre-dose measurements (-45 min and -15 min) and the trough measurements (23:15 h and 23:45 h post-dose) are included. The endpoints are the change from baseline in FVC following the morning dose on Day 1 and at Week 12. Where the FVC at any one timepoint is smaller than at baseline, a negative value can occur.|Day 1 and week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization||Liters||Standard Error|Least Squares Mean
669135|NCT01715298|Secondary|"Change From Baseline in Percentage of Days Able to Perform Usual Daily Activities"|"Patients are reporting symptoms by using an electronic diary. The electronic diary has 9 symptom questions each morning and each evening. One of the symptom questions of the evening questionnaire relates to the impact of COPD symptoms on the performance of usual daily activities (“Did your respiratory symptoms stop you performing your usual daily activities today“). The answer with the lowest symptom score is “not at all.” A day able to perform usual daily activities is defined from diary data as any day where the patient was not prevented from performing their usual daily activities due to respiratory symptoms. The change from baseline in the percentage of “days able to perform usual daily activities” is calculated from the mean percentage of days with this answer over the 12 week treatment period, with the baseline beingThe baseline is calculated from the run-in epoch prior to randomization."|Day 1 to week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization||Percentage of days||Standard Error|Least Squares Mean
669166|NCT01715064|Secondary|State-Trait Anxiety Inventory - Questionnaire(STAI)|Correlations will be assessed between cortical silent period and acute anxiety.|10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').||||||
673917|NCT01656850|Primary|Plasma Fasting Glucose at the Baseline and the End of 3-month Dietary Intervention||at the baseline and at the end of 3-month dietary intervention|||mg/dL||Standard Deviation|Mean
669136|NCT01715298|Secondary|"Change From Baseline in the Percentage of Days With no Daytime Symptoms"|"Patients are reporting symptoms by using an electronic diary. The electronic diary has 9 symptom questions each morning and each evening. Each question can be answered with one of four pre-defined answers, corresponding to a unit value of 0-3, where 0 stands for the lowest and 3 for the most severe symptom experience. A day with no daytime symptoms is defined from diary data as any day where the patient has recorded in the evening no cough, no wheeze, no production of sputum, and no feeling of breathlessness (other than when running) during the past approximately 12 hours in the evening questionnaire. The change from baseline in the percentage of days with “no daytime symptoms” is calculated from the mean percentage of days with this answer over the 12 week treatment period, with the baseline being. The baseline is calculated from the run-in epoch prior to randomization."|Day 1 to week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization||Percentage of days||Standard Error|Least Squares Mean
669137|NCT01715298|Secondary|"Change From Baseline in the Percentage of Nights With no Nighttime Awakenings"|"Patients are reporting symptoms by using an electronic diary. The electronic diary has 9 symptom questions each morning and each evening. One of the symptom questions of the morning questionnaire relates to the number of awakenings due to COPD symptoms during the previous night. The answer with the lowest symptom score is “no waking due to symptoms.” A night with no nighttime awakening is defined from diary data as any night where the patient did not wake up due to symptoms. The change from baseline in the percentage of nights with “no nighttime awakening” is calculated from the mean percentage of nights with this answer over the 12 week treatment period, with the baseline being The baseline is calculated from the run-in epoch prior to randomization."|Day 1 and week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization||Percentage of nights||Standard Error|Least Squares Mean
669138|NCT01715298|Secondary|Change From Baseline in Daily Symptom Scores|Patients are reporting symptoms by using an electronic diary. The electronic diary has 9 symptom questions each morning and each evening. Each question can be answered with one of four pre-defined answers, corresponding to a unit value of 0-3, where 0 stands for the lowest and 3 for the most severe symptom experience. Symptom scores are calculated as the mean of the combined daily symptom scores (combined from morning and evening scores) for each patient over 12 weeks (Day 1 to week 12). The baseline is calculated from the run-in epoch prior to randomization. The change from baseline in the least squares mean daily symptom scores over the 12 week treatment period is provided. Where the mean daily symptom score over the 12 week treatment period is lower than the baseline, the result is negative. A negative result indicates an improvement in COPD symptom severity.|day 1 to week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame.||Score||Standard Error|Least Squares Mean
669139|NCT01715298|Secondary|Change From Baseline in the Percentage of Days Without Rescue Medication Use|Patients report the number of puffs of rescue medication (salbutamol / albuterol) using an electronic diary. The use of rescue medication is analyzed as the change from baseline in the percentage of days without usage of rescue medication over the 12 weeks treatment period. The baseline is calculated as the percentage of days without usage of rescue medication from during the the run-in epoch prior to randomization.|Baseline and week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. week 12||percentage of days||Standard Error|Least Squares Mean
669140|NCT01715298|Secondary|Change From Baseline in Mean Number of Puffs of Rescue Medication Per Day|Patients report the number of puffs of rescue medication (salbutamol / albuterol) using an electronic diary. The use of rescue medication is analyzed as the change from baseline in the mean daily number of puffs used per patient over the 12 weeks treatment period. The baseline is calculated from the run-in epoch prior to randomization (mean number of puffs per day). A negative number indicates a reduction in the mean daily number of puffs of rescue medication.|Baseline and week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. Week 12||Number of puffs||Standard Error|Least Squares Mean
669141|NCT01715298|Secondary|Breathlessness Assessed by Transition Dyspnea Index|Breathlessness at week 12 is measured using the interviewer-administered Transition Dyspnea Index (TDI). On day 1, breathlessness is assessed by the interviewer-administered Baseline Dyspnea Index (BDI). The change from BDI to TDI is assessed, with the TDI total score ranging from -9 to +9 units of the scale. The lower the score, the more deterioration in severity of dyspnea. Patients are considered to have clinically significant improvement (MCID) with the TDI score change versus BDI being equal to or greater than 1.|Week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. Week 12||Score||Standard Error|Least Squares Mean
669142|NCT01715298|Secondary|Change From Baseline in the Health Status Assessed by St. George’s Respiratory Questionnaire|The health status, as reported by the patients, is assessed using the St. George's Respiratory Questionnaire (SGRQ). The SGRQ is a 50 item scale assessing symptoms, patient activities and impact of the disease. Scores range from 0 to 100 units, with higher scores indicating more limitations. The assessment is based on total score as well as the percentage of patients with clinically significant improvement at week 12 versus day 1. A clinically meaningful improvement (MCID) in SGRQ is defined as a decrease of 4 or more units of the SGRQ scale in the total score, as compared to baseline (change from baseline).|Week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. Week 12||Score||Standard Error|Least Squares Mean
669143|NCT01715298|Secondary|Mean Trough Forced Expiratory Volume in One Second|Mean trough Forced Expiratory Volume in one second (FEV1) is assessed as the arithmetic mean of two FEV1 measurements, conducted within the last hour of a 24 hour period from a morning dose, either that of day 1 or at week 12 of treatment. The data is reported as the change from baseline (CFB), with the baseline being the arithmetic mean of the two pre-dose measurements (-45 min and -15 min) preceding the serial lung function measurements on Day 1|Day 1 and week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. Day 1and Week 12||Liters||Standard Error|Least Squares Mean
669144|NCT01715298|Secondary|Change From Baseline in Forced Expiratory Volume in One Second at All Individual Timepoints|The Forced Expiratory Volume in one second (FEV1) assessments for all individual time points of the serial measurements on day 1 and at week 12 are analyzed. Time points of the serial lung function measurements are 5 min, 15 min, 1:00 h, 2:00 h, 4:00 h, 6:00 h, 8:00 h, and 11:55 h after the morning dose. The table indicates the percent change from baseline (CFB) in FEV1 and standard deviation in brackets. Where the FEV1 is lower than at baseline, a negative percent value can occur.|Day 1 and week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. Day 1and Week 12||Percent||Standard Deviation|Mean
669145|NCT01715298|Secondary|Change From Baseline in Standardized Area Under The Curve for Forced Expiratory Volume in One Second for Different Time Spans Post Dosing|"The standardized Area Under the Curve (AUC) for Forced Expiratory Volume in one second (FEV1FEV1) is assessed for different time spans (0-4 h, 4-8 h, 8-12 h) within the overall serial measurement post dosing (FEV1 AUCs Time Spans), at day 1 and at week 12 of treatment. Serial lung function measurements are taken at various the following time points post dosing on day 1 and at week 12 to calculate the FEV1 AUC for these different time spans: .5 min, 15 min, 1:00 h, 2:00 h, 4:00 h, 6:00 h, 8:00 h, and 11:55 h after the morning dose.
The endpoint was the change from baseline (CFB) in FEV1 AUC0-12h following the morning dose at day 1 or week 12, respectively, (defined as the mean FEV1 change from baseline over 5 min to 11 h 55 mins divided by 11 h 50 mins). Where the FEV1 AUC is smaller than at baseline, a negative value can occur."|Day 1 and Week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. Day 1and Week 12||Liters||Standard Error|Least Squares Mean
669146|NCT01715298|Secondary|Change From Baseline in Standardized Area Under the Curve (AUC(0-12h)) for Forced Expiratory Volume in One Second Post Dosing|"The standardized Area Under the Curve (AUC) for Forced Expiratory Volume in one second (FEV1) post dosing (FEV1 AUC) is assessed at day 1 of treatment. Serial lung function measurements are taken at the following various time points post dosing at day 1 to calculate the FEV1 AUC: 5 min, 15 min, 1:00 h, 2:00 h, 4:00 h, 6:00 h, 8:00 h, and 11:55 h after the morning dose.
.The endpoint was the change from baseline (CFB) in FEV1 AUC0-12h following the morning dose at day 1 (defined as the mean FEV1 change from baseline over 5 min to 11 h 55 mins divided by 11 h 50 mins). Where the FEV1 AUC is smaller than at baseline, a negative value can occur."|Day 1|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. Day 1||Liters||Standard Error|Least Squares Mean
669147|NCT01715298|Primary|Change From Baseline in Standardized Area Under the Curve for Forced Expiratory Volume in One Second Post Dosing|"The standardized Area Under the Curve (AUC) for Forced Expiratory Volume in one second (FEV1) post dosing (FEV1 AUC) is measured at week 12 of treatment. Serial lung function measurements are taken at the following time points following dosing at week 12 to calculate the FEV1 AUC: 5 min, 15 min, 1:00 h, 2:00 h, 4:00 h, 6:00 h, 8:00 h, and 11:55 h after the morning dose.
The primary endpoint was the change from baseline in FEV1 AUC0-12h following the morning dose at Week 12 (defined as the mean FEV1 change from baseline (CFB) over 5 min to 11 h 55 mins divided by 11 h 50 mins). Where the FEV1 AUC is smaller than at baseline, a negative value can occur"|Week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. analyzed participants had values at both baseline and the corresponding time frame, i.e. week 12||Liters||Standard Error|Least Squares Mean
669148|NCT01715207|Secondary|Central Aortic PWV(Pulsed Wave Velocity)|Aortic PWV was measured according to the well-validated method using MRI 19. From the velocity-encoded MRIs, aortic contours were automatically detected and manually adjusted in each slice area throughout the cardiac cycle. The transit time between the flow curves of each region of the aorta was determined from the midpoint of the systolic up-slope on the flow versus time curve 26-28. The up-slopes were identified by drawing a line between the points of 40% and 60% maximum velocity on the waveform. The distance between each aortic level was measured on black blood images using a curved line along the center of the aorta. Based on these data, the regional PWV was calculated as the ratio of the distance between levels and the time differences between the arrival of the pulse wave at each level. The PWV was measured at two regions: the proximal aorta (proximal PWV between level 1 and level 2) and the entire aorta (PWV-total between level 1 and level 4).|6 months|MFS patients were recruited at Samsung Medical Center from November 2009 to October 2014. All patients were receiving atenolol as standard β-blocker therapy.||m/s||Standard Deviation|Mean
669167|NCT01715064|Secondary|Profile of Mood States Questionnaire(PoMS)|Correlations will be assessed between cortical silent period and acute mood state.|10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').||||||
669168|NCT01715064|Primary|Change From Baseline in Cortical Silent Period (CSP) Will be Determined Using Transcranial Magnetic Stimulation (TMS) of the Motor Cortex.|CSP is a measure of cortical inhibition that is negatively related to anxiety, stress, and depression.|10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').|||seconds||Standard Deviation|Mean
673918|NCT01656850|Primary|Blood Pressure at the Baseline and at the End of 3-month Dietary Intervention||at the baseline and at the end of 3-month dietary intervention|||mmHg||Standard Deviation|Mean
669149|NCT01715207|Primary|Central Aortic Distensibility by MRI|Analyses of the MRIs were performed using commercial software (Argus version 4.02, Siemens Medical Systems, Germany) by experienced observers who were blinded to patient information. To measure central aortic distensibility, the systolic and diastolic cross-sectional areas were measured by manual contouring of the aorta through the cardiac cycle on the cine image. Distensibility at the four regions was calculated as the mean of values obtained from the following equation: Distensibility = (Amax - Amin)/[Amin × (Pmax - Pmin)](10-3mm/Hg), where Amax is the maximal (systolic) aortic area, Amin is the minimal (diastolic) aortic area, Pmax is the systolic blood pressure (SBP), and Pmin is the diastolic blood pressure (DBP). Central aortic blood pressure measured non-invasively by SphygmoCor was used for systolic and diastolic blood pressure.|6 months|MFS patients were recruited at Samsung Medical Center from November 2009 to October 2014. All patients were receiving atenolol as standard β-blocker therapy.||(mmHg ^ -1) x 10 ^ -3||Standard Deviation|Mean
669150|NCT01715129|Secondary|Cmin of Triptorelin in Subset of 18 Subjects||At Day 92 and 183|Day 92: Four subjects (presenting particularly high levels of triptorelin) were excluded from 18-subject subset.||ng/mL||Standard Deviation|Mean
669151|NCT01715129|Secondary|Area Under the Concentration Versus Time Curve Between 0 and 24 Hours (AUC0-24) of Triptorelin||At 1, 2, 3, 4, 5, 6, 7, 8 and 24 hours after first dose on Day 1|PK profile was assessed in a subset of 18 subjects.||h*ng/mL||Standard Deviation|Mean
669152|NCT01715129|Secondary|Peak Plasma Concentration Value (Cmax) of Triptorelin||At 1, 2, 3, 4, 5, 6, 7, 8 and 24 hours after first dose on Day 1|PK profile was assessed in a subset of 18 subjects.||ng/mL||Standard Deviation|Mean
669153|NCT01715129|Secondary|Time to Cmax (Tmax) of Triptorelin||At 1, 2, 3, 4, 5, 6, 7, 8 and 24 hours after first dose on Day 1|Pharmacokinetic (PK) profile was assessed in a subset of 18 subjects.||Hours||Full Range|Median
669154|NCT01715129|Secondary|Percentage of Subjects With Adverse Events||Up to Day 183|All subjects who received at least one dose of study treatment were included in safety population.||Percentage of subjects|||Number
669155|NCT01715129|Secondary|Clinically Apparent Tumor Progression|Tumour progression was recorded according to the Investigator’s clinical judgement, considering the PSA levels and any other indications of disease; the clinical confirmation might be supplemented by radiological or other investigations or scans if required. The lack of clinically apparent tumour progression was assessed at Day 92 (prior to administration of the second dose) and Day 183 (end of study visit).|Day 92 and 183|ITT population||participants|||Number
669156|NCT01715129|Secondary|Percentage of Subjects With Normal and Abnormal PSA Levels at Day 183 (End of Study Visit)|"0-4 ng/mL (normal PSA value)
>4 ng/mL (abnormal PSA levels)"|At Day 183|Subjects completed Day 183 visit (End of Study)||Percentage of subjects|||Number
669157|NCT01715129|Secondary|Percentage Change in Prostate Specific Antigen (PSA) Levels From Baseline in All Subjects|Serum PSA level was presented throughout the study using descriptive statistics displaying raw values, change from Baseline and percentage change from Baseline at each visit in all subjects from the ITT population only. Additionally, the PSA level was described in subjects with elevated PSA levels (i.e. >4 ng/mL) at study entry, and the proportion of subjects with normal PSA levels (i.e. [0-4] ng/mL) at Day 183 compared to Baseline was presented.|From Day 1 (Baseline) to Day 183 (End of study)|ITT population at End of Study (Day 183). One subject had no data.||Percentage Change||Standard Deviation|Mean
669158|NCT01715129|Secondary|Plasma Triptorelin Levels (Cmin)|Minimal triptorelin plasma concentration at the end of each dosage interval just before the next dose injection (Cmin) for Days 92 and 183 were assessed.|At Day 92 and 183|ITT population. No samples were collected from 4 subjects at Day 92 and 9 subjects at Day 183||ng/mL||Standard Deviation|Mean
669159|NCT01715129|Secondary|Time to Achieve Castration (Tcast)|Time to castration (Tcast) from first administration date until first observed serum testosterone level <50 ng/dL or <1.735 nmol/L evaluated using the immunoassay method only (i.e. defined as the number of days between the injection time at Day 1 and castration achievement)|Up to Day 36|ITT population||Day||95% Confidence Interval|Median
669160|NCT01715129|Secondary|Percentage of Subjects Demonstrating Castration With Testosterone Level <50 ng/dL at Day 95|Percentage of subjects demonstrating castration at Day 95 (3-4 days after administration of the second dose to assess the suppression of acute-on-chronic effect following the second administration) were also assessed using the LC-MS/MS method and missing data imputed by immunoassay method (at time points when LC-MS/MS data was planned to be available only) and summarised using descriptive statistics on the ITT and IC populations.|Day 95|IC1 population.||Percentage of subjects||95% Confidence Interval|Number
669161|NCT01715129|Secondary|Probability of Testosterone <50 ng/dL|"Probability of testosterone <50 ng/dL from Day 29 to Day 183 was assessed as a secondary endpoint using the time to event from first administration date to first observed (and subsequently confirmed if assessment not performed at end of study or early withdrawal visits) serum testosterone level ≥50 ng/dL or ≥1.735 nmol/L at or after Day 29, assessed using the LC-MS/MS Method and Missing Data imputed by immunoassay method Kaplan-Meier Analysis.
LC-MS/MS: Liquid Chromatography–Tandem Mass Spectrometry"|Day 29 through Day 183|Intention-to-treat (ITT) population: All treated subjects||Proportion of subjects||95% Confidence Interval|Number
669162|NCT01715129|Secondary|Percentage of Subjects Demonstrating Castration Before Administration of the Second Dose|Percentage of subjects demonstrating castration at Day 92 (before administration of the second dose) were also assessed using the LC-MS/MS method and missing data imputed by immunoassay method (at time points when LC-MS/MS data was planned to be available only) and summarised using descriptive statistics on the ITT and IC populations.|At Day 92|Initially Castrated (IC1) population: All treated subjects with testosterone levels <50 ng/dL at Day 29 or at Day 36, assessed with the LC-MS/MS method and missing data imputed by immunoassay method.||Percentage of subjects||95% Confidence Interval|Number
669163|NCT01715129|Primary|Percentage of Subjects Demonstrating Castration at Day 29 and Maintaining Castration at Day 183|Percentage of subjects castrated (i.e. with serum testosterone <50 ng/dL or 1.735 nmol/L, using the LC-MS/MS method and missing data imputed by immunoassay method (at time points when LC-MS/MS data was planned to be available only) and the proportion with castration maintained at Day 183 (after receiving 2 S.C. administrations of triptorelin pamoate, three months apart); they were calculated along with their respective 95% confidence intervals (CI) using exact methods on the ITT population at Day 29 and on the initially castrated (IC) population at Day 183|At Day 29 and 183|N=Number of subjects attending the visit||Percentage of subjects||95% Confidence Interval|Number
669170|NCT01714635|Secondary|Mean Diopter Range With VA of 20/40 or Better|"Mean diopter range in which VA of 20/40 or better was achieved at six months. Note: diopter range outcome measure was obtained from a substudy group that included the first 10 study sites to reach enrollment goals. Among these 10 sites, the first 60 subjects in each lens group (approximately*) to reach the 6-month visit were included in the substudy.
* The intent was to enroll 60 subjects per group, but group #1, group #2, and the monofocal group had 59, 63, and 61 subjects, respectively."|six months|eyes||diopters||Standard Deviation|Mean
669171|NCT01714635|Primary|Mean Monocular Distance-corrected Near Visual Acuity (VA) at 40 cm|Mean (LogMAR) monocular distance-corrected near VA at 40 cm at six months postoperative|six months|eyes||LogMAR VA||Standard Deviation|Mean
669172|NCT01714609|Primary|Patients With Change in HVPG From Baseline|Number of participants with a decrease in HPVG that was > 10% of baseline|Three Months|||participants|||Number
669173|NCT01714544|Primary|Investigator's Global Assessment (IGA)|The proportion of subjects who demonstrate an IGA score of clear (0) or almost clear (1).|28 days|Intent to treat population, with LOCF for missing data||percentage of subjects||95% Confidence Interval|Number
669174|NCT01714505|Primary|Safety, Frequency of Hypoglycemia|Hypoglycemic episodes are defined as BG < 3.9mmol/L|40 hours (x 2 admissions)|||hypoglycemic episodes/participant||Standard Deviation|Mean
669175|NCT01714505|Secondary|Efficacy, Time Spent in Target Range|Percentage of time in the target range of 3.9–10 mmol/L (70–180 mg/dL).|40 hours (x2 admissions)|||percentage of time spent in range||Standard Deviation|Mean
669176|NCT01714505|Primary|Safety, Low Blood Glucose Index (LBGI)|"The LBGI reflects the frequency and extent of hypoglycemic episodes and presents the results in “risk space.” Thus the LBGI is a weighted average of the number of hypoglycemic readings, with progressively increasing weights as BG levels go down. The increase of the weights follows a risk function; thus the LBGI has been associated with risk for hypoglycemia and prediction of severe hypoglycemic episodes.
LBGI < 2.5 is associated with low risk of hypoglycemia, 2.5 < LBGI < 5 is associated with a moderate risk of hypoglycemia and LBGI > 5 is associated with a high risk of hypoglycemia."|40 hours (x2 admissions)|||index score||Standard Deviation|Mean
669177|NCT01714492|Secondary|Condyle Contact Stress at Maximum Flexion During Deep Knee Bend Activity||10 yrs post-operative|||MPa|Participants|Standard Deviation|Mean
669178|NCT01714492|Secondary|Condyle Contact Area at Maximum Flexion During Deep Knee Bend Activity||10 yrs post-operative|||mm^2|Participants|Standard Deviation|Mean
669179|NCT01714492|Primary|Range of Motion During Flexion of Deep Knee Bend Activity||10 yrs post-operative|||degrees|Participants|Standard Deviation|Mean
669180|NCT01714492|Primary|Femoral Axial Rotation With Respect to the Tibia During Deep Knee Bend Activity||10 yrs post-operative|||degrees|Participants|Standard Deviation|Mean
669181|NCT01714492|Secondary|In Vivo Knee Force Values From Fluoroscopy Evaluation During Deep Knee Bend Activity|"The intended unit of measure is times Body Weight (or xBW), relating to a ratio."|10 yrs post-operative|Subjects implanted with the Sigma Posterior Stabilizing Rotating Platform TKA including a polyethylene insert with 4 beads that allow for determination of polyethylene rotation||times body weight|Participants|Standard Deviation|Mean
669182|NCT01714492|Primary|In Vivo Linear Knee Kinematics From Fluoroscopy Evaluation During Deep Knee Bend Activity|The values that were reported indicate the motion of the contact point from full extension to patient's maximum flexion. Throughout flexion, if the point translated forward (anteriorly) atop the tibial tray, the number was reported as positive. If the point traveled backwards (posteriorly) atop the tibial tray, the number was reported as negative.|10 yrs post-operative|Subjects implanted with the Sigma Posterior Stabilizing Rotating Platform TKA including a polyethylene insert with 4 beads that allow for determination of polyethylene rotation.||mm|Participants|Standard Deviation|Mean
669183|NCT01714336|Secondary|Number of Participants Who Died|All-cause mortality at 6 months|6 months after surgery|||participants|||Number
669184|NCT01714336|Secondary|Number of Participants With Cerebrovascular Accident (CVA) Diagnosis|CVA diagnosed within 6 months of surgery|Within 6 months of surgery|||participants|||Number
669185|NCT01714336|Secondary|Number of Participants With Myocardial Infarction (MI) Diagnosis|MI diagnosed within 6 months of surgery|Within 6 months of surgery|||participants|||Number
669186|NCT01714336|Secondary|Number of Participants With Wound Complications|Wound complications diagnosed within 6 months of surgery|Within 6 months of surgery|||participants|||Number
669187|NCT01714336|Secondary|Number of Participants With Venous Thromboembolism (VTE) Diagnosis|Incidence of symptomatic VTE diagnosed within 6 months of surgery|Within 6 months of surgery|||participants|||Number
669188|NCT01714336|Secondary|Calculated Blood Loss|Calculated blood loss|5 days|||cc||Standard Deviation|Mean
669189|NCT01714336|Secondary|Mean Number of Units Transfused|Mean number of units transfused per patient|5 days|||units/participant transfused||Standard Deviation|Mean
669190|NCT01714336|Primary|Number of Participants Who Received a Hospitalization Transfusion|Proportion of patients transfused at least 1 unit of packed red blood cells during hospital admission|5 days|||participants|||Number
669191|NCT01714232|Secondary|MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) in the High Glucose Range (>180 mg/dL)|"Using samples with Blood Glucose >180 mg/dL, the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI laboratory reference values were compared. MARD was calculated from the sum of all |(BG meter)-(BG reference)|/(BG reference) assessments, divided by the number of assessments, then multiplied by 100(%). Each evaluable sample was tested on all 5 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD values indicate smaller differences between meter value and the reference value. Higher MARD values indicate higher differences between meter value and the reference value."|8 hours|Same number (113) of BG results was possible for each BGMS. Staff collected capillary samples from each subject as described in primary objective population description, of which 113 samples were greater than 180 mg/dL.||Percent Difference|Participants|Standard Error|Mean
669227|NCT01713530|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes|According to the Novo Nordisk definition for confirmed hypoglycaemic episodes (severe hypoglycaemia and/or a measured Plasma Glucose (PG) <3.1 mmol/L(56 mg/dL))|During Weeks 0-26|The safety Analysis Set (SAS): included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation “as treated”.||episodes|||Number
669192|NCT01714232|Secondary|MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) in the Low Glucose Range(<=80 mg/dL)|"Using fresh and glycolyzed samples with Blood Glucose (BG) <=80 mg/dL, the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI laboratory reference values were compared. MARD was calculated from the sum of all |(BG meter)-(BG reference)|/(BG reference) assessments, divided by the number of assessments, then multiplied by 100(%). Each evaluable sample was tested on all 5 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD values indicate smaller differences between meter value and the reference value. Higher MARD values indicate higher differences between meter value and the reference value."|8 hours|Same number (93) of BG results was possible for each BGMS. Staff collected 3 capillary samples from each subject (total 314), of which 93 samples were less than or equal to 80 mg/dL.||Percent Difference|Participants|Standard Error|Mean
669193|NCT01714232|Primary|MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Overall Tested Glucose Range|"Using the overall Blood Glucose (BG) range (27 to 460 mg/dL), the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI laboratory reference values were compared. MARD was calculated from the sum of all |(BG meter)-(BG reference)|/(BG reference) assessments, divided by the number of assessments, then multiplied by 100(%). Each evaluable sample was tested on all 5 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD values indicate smaller differences between meter value and the reference value. Higher MARD values indicate higher differences between meter value and the reference value."|8 hours|314 BG results possible for each BGMS (318-4=314). Staff collected 3 capillary samples from each subject-total 318 samples. One subject hematocrit(56%) was above the study evaluable limit 55%, so that subject's 3 samples were not analyzed. One sample from another subject was below meter operating limit (12.3mg/dL) so it was not analyzed.||Percent Difference||Standard Error|Mean
669196|NCT01713998|Secondary|Subject Assessment of Improvement at 180 Days Post-treatment|Subjects completed a Patient Assessment Questionnaire at 180 days post-treatment by referring to their image in a mirror, their 180-day post-treatment photos, and their pre-treatment photos, and reporting if any improvement was noted on the right and left sides of their face and neck.|180 days post-treatment|||percentage of participants|||Number
669197|NCT01713998|Secondary|Subject Assessment of Improvement at 90 Days Post-treatment|Subjects completed a Patient Assessment Questionnaire at 90 days post-treatment by referring to their image in a mirror, their 90-day post-treatment photos, and their pre-treatment photos, and reporting if any improvement was noted on the right and left sides of their face and neck.|90 days post-treatment|||percentage of participants|||Number
669198|NCT01713998|Secondary|Quantitative Assessment of Brow Lift at 90 Days Post-treatment|Quantitative assessment and analysis of brow lift from baseline to 90 days post-treatment was completed comparing brow lift achieved using standard energy settings compared to adjusted energy settings. The number of subjects with 1 mm or more brow lift is reported. Note: Because the submental region was treated using standard energy settings in all study groups, a quantitative analysis of lift in this region between the study groups would most likely not be informative, and therefore was not completed.|90 days post-treatment|||Participants|||Number
669199|NCT01713998|Primary|Overall Improvement in Skin Laxity on the Face and Neck|A split-face comparison of improvement in overall lifting and tightening of skin was completed by three masked assessors. Pre-treatment and 90 days post-treatment photos from 45 subjects who returned for their 90-day follow-up visit were reviewed, assessing for improvement in skin laxity, i.e., lifted and tightened skin in the areas treated using treatment energy settings based on subjects' assigned study group.|90 days post-treatment|||Participants|||Number
669200|NCT01713998|Primary|Subjects' Assessment of Pain During Treatment With Lower Energy Settings|"Subjects' sensory response to the Ulthera treatment exposures were recorded using a validated Numeric Rating Scale (NRS,0-10), for each anatomical region treated and energy settings used, with 0 representing no pain and 10 representing the worst pain possible.
Pain scores were collected in a consistent manner, following treatment of each section of the face and neck on both sides (submental, submandibular, cheek, periorbital, infraorbital, and forehead), and for each transducer used. Split-face comparisons of pain scores obtained during study treatment by research staff blinded to the energy settings used were completed."|Participants were assessed for the duration of study treatment, an average of 75 minutes|||units on a scale||Full Range|Mean
669201|NCT01713933|Secondary|Patient Satisfaction|Patient satisfaction was determined by scores on a patient satisfaction questionnaire (PSQ) completed at 180 days post-treatment. Subjects indicated how satisfied they were with study treatment, i.e., Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Pre-treatment and Day 90 post-treatment photographs were available for viewing during the assessment.|Baseline to 180 days post-treatment|Thirty-one (31) subjects returned for the 180 day post-treatment visit. Two subjects were lost-to-follow-up. One subject was excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period.||Percentage of Participants|||Number
669228|NCT01713530|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|Change from baseline in FPG after 26 weeks of treatment|Week 0, week 26|The FAS included all randomised subjects (2 subjects-baseline FPG not measured). The statistical evaluation of the FAS followed the ITT principle and subjects contributed to the evaluation “as randomised”.||mmol/L||Standard Error|Least Squares Mean
669202|NCT01713933|Secondary|Patient Satisfaction|Patient satisfaction was determined by scores on a patient satisfaction questionnaire (PSQ) completed at 90 days post-treatment. Subjects indicated how satisfied they were with study treatment, i.e., Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Pre-treatment and Day 90 post-treatment photographs were available for viewing during the assessment.|Baseline to 90 days post-treatment|wenty-seven (27) subjects returned for the 90 day post-treatment visit. Five (5) 90 day visits were missed, including one subject excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period. Two (2) subjects were lost-to-follow-up.||Percentage of Participants|||Number
669203|NCT01713933|Secondary|Overall Aesthetic Improvement|"Based on Global Aesthetic Improvement Scale (GAIS) Scores; PGAIS completed by a physician assessor, SGAIS completed by the study subject. . The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:
- Very Much Improved
- Much Improved
- Improved
- No Change
- Worse"|Baseline to180 days post-treatment|Thirty-one (31) subjects returned for the 180 day post-treatment visit. Two subjects were lost-to-follow-up. One subject was excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period.||Percentage of Participants|||Number
669204|NCT01713933|Secondary|Overall Aesthetic Improvement|"Based on Global Aesthetic Improvement Scale (GAIS) Scores; PGAIS completed by a physician assessor, SGAIS completed by the study subject. . The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:
- Very Much Improved
- Much Improved
- Improved
- No Change
- Worse"|Baseline to 90 days post-treatment|Twenty-seven (27) subjects returned for the 90 day post-treatment visit. Five (5) 90 day visits were missed, including one subject excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period. Two (2) subjects were lost-to-follow-up.||Percentage of Participants|||Number
669205|NCT01713933|Secondary|Overall Aesthetic Improvement|"Based on Global Aesthetic Improvement Scale (GAIS) Scores; PGAIS completed by a physician assessor, SGAIS completed by the study subject. . The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:
- Very Much Improved
- Much Improved
- Improved
- No Change
- Worse"|Baseline to 60 days post-treatment|Thirty-one (31) subjects returned for the 60 day post-treatment visit. Two subjects were lost-to-follow-up. One subject was excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period.||Percentage of Participants|||Number
669206|NCT01713933|Secondary|Change in Dermal Thickness|Based on ultrasonic skin analysis, the change in dermal thickness from baseline to 180 days post-treatment was calculated.|Baseline to180 days post-treatment|Thirty-one (31) subjects returned for the 180 day post-treatment visit. Two subjects were lost-to-follow-up. One subject was excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period.||Millimeters||Full Range|Mean
669207|NCT01713933|Secondary|Change in Dermal Thickness|Based on ultrasonic skin analysis, the change in dermal thickness from baseline to 90 days post-treatment was calculated.|Baseline to 90 days post-treatment|Twenty-seven (27) subjects returned for the 90 day post-treatment visit. Five (5) 90 day visits were missed, including one subject excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period. Two (2) subjects were lost-to-follow-up.||Millimeters||Full Range|Mean
669208|NCT01713933|Secondary|Quantitative Improvement in Skin Laxity|Assess change in brachial volume based on brachial tissue measurements.|Baseline to 90 days post-treatment|Twenty-seven (27) subjects returned for the 90 day post-treatment visit. Five (5) 90 day visits were missed, including one subject excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period. Two (2) subjects were lost-to-follow-up.||percentage of participants improved|||Number
669209|NCT01713933|Primary|Improvement in Obtaining Lift and Tightening of Brachial Skin Laxity|Improvement in overall lifting and tightening of brachial skin laxity as determined by masked, qualitative assessment of photographs at 90 days post-treatment compared to baseline.|Baseline to 90 days post-treatment|Twenty-seven (27) subjects returned for the 90 day post-treatment visit. Five (5) 90 day visits were missed, including the one subject excluded from analyses as an outlier due to high Body Mass Index (BMI) and substantial weight gain during the study period. Two (2) subjects were lost-to-follow-up.||percentage of participants improved|||Number
669210|NCT01713686|Secondary|Subject Satisfaction at 180 Days Post-treatment|"Subject satisfaction was measured at 180 days post-treatment using a Patient Satisfaction Questionnaire (PSQ). A 5-point PSQ scale was used with the following descriptors:
Very Satisfied
Satisfied
Neither Satisfied or Dissatisfied
Dissatisfied
Very Dissatisfied
Satisfied = Very Satisfied + Satisfied
Dissatisfied = Dissatisfied + Very Dissatisfied"|180 days post-treatment|This secondary outcome measure was based on the responses provided from 116 subjects completing a 180 day post-treatment visit.||percentage of participants|||Number
669211|NCT01713686|Secondary|Subject Satisfaction at 90 Days Post-treatment|"Subject satisfaction was measured at 90 days post-treatment using a Patient Satisfaction Questionnaire (PSQ). A 5-point PSQ scale was used with the following descriptors:
Very Satisfied
Satisfied
Neither Satisfied or Dissatisfied
Dissatisfied
Very Dissatisfied
Satisfied= Very Satisfied + Satisfied
Dissatisfied=Dissatisfied + Very Dissatisfied"|90 days post-treatment|This secondary outcome measure was based on the responses provided from 116 subjects completing a 90 day post-treatment visit.||percentage of participants|||Number
669212|NCT01713686|Primary|Percentage of Participants With a Reduction in Chest Wrinkles at 180 Days Post Treatment|"Assessment of improvement, in a blinded fashion, using a Chest Wrinkle Scale at 180 days post-treatment. However, during conduct of the trial, the Chest Wrinkle scale was deemed inadequate as a primary endpoint in this study. Therefore, conduct of a traditional blinded masked assessment, the gold-standard measure in aesthetics, was used as the primary endpoint, improvement in wrinkles and lines of the décolletage as determined by a blinded, masked, qualitative assessment of photographs at 180 days .post-treatment compared to baseline.
Improvement = a blinded evaluator assessed an Improvement when evaluating a masked, paired photo set and correctly chose the Post treatment photo.
Incorrect = a blinded evaluator assessed an Improvement when evaluating a masked, paired photo set but incorrectly chose the Post treatment photo."|180 days post treatment|The analysis population was based on the Last Value Carried Forward (LVCF) analysis method for determining overall efficacy, i.e., if a D90 but not D180 value was present, the LVCF is the D90 value. Following this method, the analysis popullation was based on 116 subjects.||percentage of participants|||Number
670066|NCT01704495|Secondary|Change From Baseline to Treatment Period (Day 57 to Day 84) for Asthma Symptom Free Days||Baseline (last 14 days before randomization) and Treatment Period (Days 57 to 84)|Full Analysis set||symptom free days||90% Confidence Interval|Least Squares Mean
669213|NCT01713686|Secondary|Overall Aesthetic Improvement at 180 Days Post-treatment|"The overall level of aesthetic improvement at 180 Days post treatment compared to baseline was assessed using a Clinician Global Aesthetic Improvement Scale (CGAIS). The CGAIS is a 5-point scale with the following descriptors:
Very much improved
Much improved
Improved
No change
Worse
The scale was completed in two steps:
Based on a live assessment of the subject while referring to the subject’s pre-treatment photographs; and
Based on a comparison of the subject’s pre-treatment photographs to current post-treatment photographs.
Improved = Very Much Improved + Much Improved + Improved"|180 days post-treatment|Analysis population was based the number of subjects completing a 180 day follow-up visit.||percentage of participants|||Number
669214|NCT01713686|Secondary|Overall Aesthetic Improvement at 90 Days Post-treatment|"The overall level of aesthetic improvement at 90 Days post treatment compared to baseline was assessed using a Clinician Global Aesthetic Improvement Scale (CGAIS). The CGAIS is a 5-point scale with the following descriptors:
Very much improved
Much improved
Improved
No change
Worse
The scale was completed in two steps:
Based on a live assessment of the subject while referring to the subject’s pre-treatment photographs; and
Based on a comparison of the subject’s pre-treatment photographs to current post-treatment photographs.
Improved = Very Much Improved + Much Improved + Improved"|90 days post-treatment|This secondary outcome measure was based on 116 subjects completing a 90 day post-treatment visit.||percentage of participants|||Number
669215|NCT01713686|Primary|Percentage of Participants With a Reduction in Chest Wrinkles at 90 Days Post Treatment|"Assessment of improvement, in a blinded fashion, using a Chest Wrinkle Scale at 90 days post-treatment. However, during conduct of the trial, the Chest Wrinkle scale was deemed inadequate as a primary endpoint in this study. Therefore, conduct of a traditional blinded masked assessment, the gold-standard measure in aesthetics, was used as the primary endpoint,i.e., improvement in wrinkles and lines of the décolletage as determined by a blinded, masked, qualitative assessment of photographs at 90 days post-treatment compared to baseline.
Improvement = a blinded evaluator assessed an Improvement when evaluating a masked, paired photo set and correctly chose the Post treatment photo.
Incorrect = a blinded evaluator assessed an Improvement when evaluating a masked, paired photo set but incorrectly chose the Post treatment photo."|90 Days post-treatment|The analysis population was based on data from subjects completing a 90 day follow-up visit. Of the 116 subjects who returned for the D90 follow-up, 113 subjects had evaluable photographs. These photos were treated as ‘missing’ by the statistician and were not included in the denominator for the masked assessment analyses.||percentage of participants|||Number
669216|NCT01713660|Secondary|Percent of Seidel Staining|Demonstration of no wound leakage as measured by Seidel test at slit lamp with fluorscein dye. A negative Seidel test result indicates no wound leakage.|Day 0 (performed immediately post-incision creation), Day 1|||percentage of eyes with negative Seidel|Participants||Number
669217|NCT01713660|Secondary|Surgeon Assessment of Workflow|Surgeon questionnaire (completed at the end of each surgery and the end of each surgical day): Were incisions created as intended?|Day 0, Operative|||percentage of yes answers|||Number
669218|NCT01713660|Primary|Demonstration That the Femtosecond Laser Consistently Produces Desired Incisions.|Evaluation of incisions created as programmed and measurement in mm. Data reported will be based on intended incision size (as programmed) vs. achieved incision size (as measured).|Day 0, Operative (Within 2 hours of incision creation)|||mm|Participants|Standard Deviation|Mean
669219|NCT01713621|Primary|Minimum Inhibitory Concentration (MIC) and Minimum Parasiticidal Concentration (MPC)|The estimated MIC and MPC were derived from the fitted parasitaemia concentration and PK/PD relationship.|up to 28 days|Model predicted MIC and MPC||ng/Ml||Standard Deviation|Mean
669220|NCT01713608|Secondary|OZ439 t½|OZ439 estimated terminal phase half life|pre-dose, 2, 4, 6, 8, 12, and 18 hours post-dose Day 1and Day 3, pre dose Day 2 and 4 hours post dose Day 2, and 24, 48, 72, 96 and 168 hours post 3rd dose and at follow up.|PK Population: All subjects who received at least one dose of study medication and who had available evaluable PK data.||hours||Standard Deviation|Mean
669221|NCT01713608|Primary|OZ439 AUCτ|OZ439 Area under the plasma concentration vs time curve from time zero to the time of the last quantifiable concentration t calculated using a log-linear trapezoidal method|pre-dose, 2, 4, 6, 8, 12, and 18 hours post-dose Day 1and Day 3, pre dose Day 2 and 4 hours post dose Day 2, and 24, 48, 72, 96 and 168 hours post 3rd dose and at follow up.|PK Population: All subjects who received at least one dose of study medication and who had available evaluable PK data.||ng*h/mL||Standard Deviation|Mean
669222|NCT01713608|Secondary|OZ439 Tmax|Time to reach maximum measured OZ439 plasma concentration|pre-dose, 2, 4, 6, 8, 12, and 18 hours post-dose Day 1and Day 3, pre dose Day 2 and 4 hours post dose Day 2, and 24, 48, 72, 96 and 168 hours post 3rd dose and at follow up.|PK Population: All subjects who received at least one dose of study medication and who had available evaluable PK data.||hours||Standard Deviation|Mean
669223|NCT01713608|Primary|OZ439 Cmax|OZ439 maximum measured plasma concentration|Blood for analysis of OZ439 will be collected at the following times: pre-dose, 2, 4, 6, 8, 12, and 18 hours post-dose Day 1and Day 3, pre dose Day 2 and 4 hours post dose Day 2, and 24, 48, 72, 96 and 168 hours post 3rd dose and at follow up.|PK Population: All subjects who received at least one dose of study medication and who had available evaluable PK data.||ng/mL||Standard Deviation|Mean
669224|NCT01713530|Secondary|Incidence of Treatment Emergent Adverse Events (TEAE)|A TEAE was defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment|Weeks 0-26|The SAS included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation “as treated”.||number of events|||Number
669225|NCT01713530|Secondary|Number of Treatment Emergent Nocturnal (00:01-05:59 am) Confirmed Hypoglycaemic Episodes|Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.|Weeks 0-26|The SAS included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation “as treated”.||episodes|||Number
669226|NCT01713530|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes|"According to the American Diabetes Association (ADA) definition following are the categories of hypoglycaemic episodes:
Severe hypoglycaemia, Documented symptomatic hypoglycaemia, Asymptomatic hypoglycaemia, Probable symptomatic hypoglycaemia and Relative hypoglycaemia"|During Weeks 0-26|The SAS included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation “as treated”.||episodes|||Number
669231|NCT01713400|Primary|T Regulatory Cell (Treg)/Total Cluster of Differentiation 4 (CD4)+ Ratio|"Median Blood Treg/Total CD4+ Ratio at day 30 following hematopoietic cell transplantation (HCT). Comparison between study arms: Ustekinumab vs. Placebo. From NCI Dictionary: T reg - A type of immune cell that blocks the actions of some other types of lymphocytes, to keep the immune system from becoming over-active. T regs are being studied in the treatment of cancer. A T reg is a type of white blood cell and a type of lymphocyte. Also called regulatory T cell, suppressor T cell, and T-regulatory cell."|30 days post transplant|All participating recipients||ratio||Full Range|Median
669232|NCT01713348|Secondary|HbA1c||Day 100 compared to day 1|Analysis performed according to the intention-to-treat principle.||Percent||Standard Deviation|Mean
669233|NCT01713348|Secondary|HbA1c (mmol/Mol)||Day 100 compared to day 1|Analysis performed according to the intention-to-treat principle. Analysis in the Type 1 population is after removal of 1 outlier.||mmol/mol||Standard Deviation|Mean
669234|NCT01713348|Secondary|Glucose Standard Deviation (SD)||Day 86 to 100 compared to day 1 to 15|||mmol/L||Standard Deviation|Mean
669235|NCT01713348|Secondary|Time in Range|Difference in time in range (70-180 mg/dL, 3.9 to 10.0 mmol/L) intervention arm compared to control arm.|Days 86 to 100 intervention arm compared to control arm|All analyses were performed according to the intention-to-treat principle.||hours per day||Standard Deviation|Mean
669236|NCT01713348|Primary|Time in Range|Intervention arm: within subject difference in time in range (70-180 mg/dL, 3.9 to 10.0 mmol/L) in final 15 days compared to baseline phase assessed separately for Type 1 and Type 2 Diabetes.|Day 86 to 100 compared to Day 1 to 15|All analyses were performed according to the intention-to-treat principle.||hours per day||Standard Deviation|Mean
669237|NCT01713283|Secondary|Percentage of Participants Experiencing Viral Relapse|Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) at end of treatment, but did not achieve an SVR.|Up to Posttreatment Week 24|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants|||Number
669238|NCT01713283|Secondary|Percentage of Participants Experiencing On-treatment Virologic Failure|"On-treatment virologic failure was defined as:
Viral breakthrough: HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or
Viral rebound: > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or
Nonresponse: HCV RNA persistently ≥ LLOQ through 8 weeks of treatment"|Up to 24 weeks|Full Analysis Set||percentage of participants|||Number
669239|NCT01713283|Secondary|Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set||percentage of participants|||Number
669240|NCT01713283|Primary|Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)|The percentage of participants discontinuing any study drug due to an adverse event was summarized.|Up to 24 weeks|Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug||percentage of participants|||Number
669241|NCT01713283|Primary|Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants with genotype 4 HCV infection who were randomized into the study and received at least 1 dose of study drug||percentage of participants|||Number
669242|NCT01713036|Secondary|Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death, and TEAEs Leading to Discontinuation|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug administration until 30+/-2 days after the last dose of study drug administration that were absent before treatment or that worsened relative to pre treatment state.|Part A and B: From the first dose of study drug administration until 30+/-2 days after the last dose of study drug administration, assessed up to 18 months|The safety analysis set included all subjects who received at least one administration of trial medication and have at least one subsequent safety assessment.||subjects|||Number
669243|NCT01713036|Secondary|Part B: Number of Subjects Who Experienced Complete Response (CR), Partial Response (PR), Stable Disease (SD) and Progressive Disease (PD)|Anti tumor activity defined as CR, PR, or stable disease and PD based on the investigator tumor evaluations performed every 2 cycles in accordance with Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. CR =Disappearance of all target lesions except lymph nodes (LN); LN must have a decrease in the short axis to less than (<)10 millimeter (mm); PR = 30% decrease in sum of diameters of target lesions taking as reference the baseline sum diameters; Progressed Disease (PD) = 20% increase in sum of diameters of target lesions; the appearance of >=1 new lesions; SD= Neither shrinkage to qualify for PR nor increase to qualify for PD taking the smallest sum diameters on study as reference. For non-target lesions a CR = Disappearance of all non-target lesions and all LN must be non-pathological in size <10 mm; Non-CR/Non PD: persistence of one or more non-target lesions; PD = unequivocal progression of existing non-target lesions or appearance of new ones.|From the screening every 2 cycles until end of the treatment, assessed up to 18 months|Safety analysis set included all subjects who received at least one administration of trial medication and had at least one subsequent safety assessment.||subjects|||Number
669244|NCT01713036|Secondary|Blood/ Plasma Concentration Ratios of Total [14C] Radioactivity||1.5 hour post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.||Ratio||Standard Deviation|Mean
669350|NCT01712074|Other Pre-specified|Pulse Rate Changes From Baseline - Week 6 (Visit 3)|The pulse rate changes from baseline at Week 6 (Visit 3) including supine pulse rate, and standing pulse rate.|Baseline and Week 6|All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)||beats per minute (bpm)||Full Range|Mean
669245|NCT01713036|Secondary|Fraction Unbound of [14C] Pimasertib|Fraction of unbound drug (fu) is defined as the ratio of unbound drug concentration to the total drug concentration multiplied by 100.|1.5 hour post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.||percentage of unbound drug||Standard Deviation|Mean
669246|NCT01713036|Secondary|Apparent Terminal Half-life (t1/2) of M445 and M554||Predose, 1.0, 2.0, 4.0, 10 and 24 hour post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.||hour||Full Range|Median
669247|NCT01713036|Secondary|Apparent Terminal Elimination Rate Constant (λz) of M445 and M554|The λz of M445 and M554 was determined from the terminal slope of the log-transformed plasma concentration curve using linear regression on terminal data points of the curve.|Predose, 1.0, 2.0, 4.0, 10 and 24 hour post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.||per hour||95% Confidence Interval|Geometric Mean
669248|NCT01713036|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of M445 and M554|AUC from time 0 to infinity (AUC0-inf), was calculated from AUC0-t + AUCextra, where AUCextra = Clast calc/lambda z (λz). Clast calc was the calculated plasma concentration at the last sampling time point at which plasma concentration was at or above the lower limit of quantification was measured and λz represents apparent terminal elimination rate constant.|Predose, 1.0, 2.0, 4.0, 10 and 24 hour post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.||hr*ng eq/mL||95% Confidence Interval|Geometric Mean
669249|NCT01713036|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time (AUC0-t) of M445 and M554|Area under the plasma concentration-time curve from time zero to the last sampling time (AUC0-t) at which the concentration is at or above the lower limit of quantification.|Predose, 1.0, 2.0, 4.0, 10 and 24 hour post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.||hr*ng eq/mL||95% Confidence Interval|Geometric Mean
669250|NCT01713036|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of M445 and M554|Time to reach maximum plasma concentration (Tmax) for the metabolites M445 and M554 was calculated.|Predose, 1.0, 2.0, 4.0, 10 and 24 hour post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.||hour||Full Range|Median
669251|NCT01713036|Secondary|Maximum Observed Plasma Concentration (Cmax) of M445 and M554|Maximum observed plasma concentration (Cmax) for the metabolites M445 and M554 was calculated.|Predose, 1.0, 2.0, 4.0, 10 and 24 hour post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.||Nanogram equivalent per milliliter||95% Confidence Interval|Geometric Mean
669252|NCT01713036|Secondary|Apparent Volume of Distribution of Total [14C] Radioactivity During the Terminal Phase Following Oral Administration (Vz/f)|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/f) was influenced by the fraction absorbed. Vz/f of total radioactivity during the terminal phase was calculated by dividing the dose with the product of area under the plasma concentration time curve and apparent terminal rate constant (dose/AUC0inf*λz).|Pre dose, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, 8.0, 10.0, 12.0, 24.0, 48.0, 72.0, 96.0 and 168.0 hours post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.||Liter||95% Confidence Interval|Geometric Mean
669253|NCT01713036|Secondary|Total Body Clearance of Total [14C] Radioactivity From Plasma Following Oral Administration (CL/f)|Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. CL/f was influenced by the fraction absorbed. Apparent body clearance of total radioactivity from plasma was calculated by dividing the dose with area under the plasma concentration time curve from zero to infinity (Dose/AUC0inf).|Pre dose, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, 8.0, 10.0, 12.0, 24.0, 48.0, 72.0, 96.0 and 168.0 hours post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.||liter per hour||95% Confidence Interval|Geometric Mean
669254|NCT01713036|Secondary|Apparent Terminal Half-life (t1/2) of Total [14C] Radioactivity||Pre dose, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, 8.0, 10.0, 12.0, 24.0, 48.0, 72.0, 96.0 and 168.0 hours post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.||hour||Full Range|Median
669255|NCT01713036|Secondary|Apparent Terminal Elimination Rate Constant (λz) of Total [14C] Radioactivity|λz of total [14C] radioactivity was determined from the terminal slope of the log-transformed plasma concentration curve using linear regression on terminal data points of the curve.|Pre dose, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, 8.0, 10.0, 12.0, 24.0, 48.0, 72.0, 96.0 and 168.0 hours post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.||per hour||95% Confidence Interval|Geometric Mean
669256|NCT01713036|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of Total [14C] Radioactivity|Area under the concentration time curve (AUC) from time zero to infinity (AUC0-inf) was calculated from AUC0-t + AUCextra, where AUCextra = Clast calc/λz. Clast calc was the calculated plasma concentration at the last sampling time point at which plasma concentration was at or above the lower limit of quantification was measured and λz represents apparent terminal elimination rate constant.|Pre dose, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, 8.0, 10.0, 12.0, 24.0, 48.0, 72.0, 96.0 and 168.0 hours post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.||hr*ng eq/mL||95% Confidence Interval|Geometric Mean
669257|NCT01713036|Secondary|Area Under the Plasma Concentration Time Curve From Time Zero to the Last Sampling Time at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) of Total [14C] Radioactivity|Area under the plasma concentration time curve from time zero to the last sampling time at which the concentration is at or above the lower limit of quantification was calculated by using mixed log linear trapezoidal rule. Unit of assessment was hour*nanogram equivalent per milliliter (hr*ng eq/mL).|Pre dose, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, 8.0, 10.0, 12.0, 24.0, 48.0, 72.0, 96.0 and 168.0 hours post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.||hr*ng eq/mL||95% Confidence Interval|Geometric Mean
669258|NCT01713036|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Total [14C] Radioactivity||Pre dose, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, 8.0, 10.0, 12.0, 24.0, 48.0, 72.0, 96.0 and 168.0 hours post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.||hour||Full Range|Median
669259|NCT01713036|Secondary|Maximum Observed Plasma Concentration (Cmax) of Total [14C] Radioactivity|Unit of assessment was nanogram equivalent per milliliter (ng eq/mL).|Pre dose, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, 8.0, 10.0, 12.0, 24.0, 48.0, 72.0, 96.0 and 168.0 hours post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.||ng eq/mL||95% Confidence Interval|Geometric Mean
669260|NCT01713036|Secondary|Apparent Volume of Distribution During the Terminal Phase Following Oral Administration (Vz/f) and the Apparent Volume of Distribution During the Terminal Phase Following Intravenous Administration (Vz) of [14C] Pimasertib|The apparent volume of distribution during the terminal phase following oral administration (Vz/f) and the apparent volume of distribution during the terminal phase following intravenous administration was calculated by using the formula=Dose/( AUC0-inf* λz).|Pre-dose, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 6, 8, 10, 12, 16, 24, and 48 hours post unlabeled pimasertib dose on Day 1; Pre-dose, 0.5, 1, 1.5, 3, 5, 7, 9, 11, 15, 23, and 47 hours post [14C] labeled pimasertib dose on Day 1|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.||Liter||95% Confidence Interval|Geometric Mean
669261|NCT01713036|Secondary|The Volume of Distribution of the Central or Plasma Compartment (Vc) of Intravenous [14C] Pimasertib|The volume of distribution of the central or plasma compartment (Vc) was calculated using the formula=Dose/C0|Pre-dose, 0.5, 1, 1.5, 3, 5, 7, 9, 11, 15, 23, and 47 hours post intravenous [14C] pimasertib dose on Day 1|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.||Liter||95% Confidence Interval|Geometric Mean
669262|NCT01713036|Secondary|Total Body Clearance of Unlabeled Pimasertib (CL/f) and Intravenous [14C] Pimasertib (CL)|The total body clearance of drug from plasma following oral administration (Cl/f) and the total body clearance of drug from plasma following intravenous administration was calculated by dividing the Dose with area under the plasma concentration time curve from time zero to infinity (AUC0 inf)=Dose/AUC0- inf.|Pre-dose, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 6, 8, 10, 12, 16, 24, and 48 hours post unlabeled pimasertib dose on Day 1; Pre-dose, 0.5, 1, 1.5, 3, 5, 7, 9, 11, 15, 23, and 47 hours post intravenous [14C] labeled pimasertib dose on Day 1|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.||liter per hour||95% Confidence Interval|Geometric Mean
669263|NCT01713036|Secondary|Apparent Terminal Elimination Rate Constant (λz) of Unlabeled Pimasertib and Intravenous [14C] Pimasertib|Apparent terminal elimination rate constant (λz) was determined from the terminal slope of the log-transformed plasma concentration curve using linear regression on terminal data points of the curve.|Pre-dose, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 6, 8, 10, 12, 16, 24, and 48 hours post unlabeled pimasertib dose on Day 1; Pre-dose, 0.5, 1, 1.5, 3, 5, 7, 9, 11, 15, 23, and 47 hours post intravenous [14C] labeled pimasertib dose on Day 1|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.||per hour||95% Confidence Interval|Geometric Mean
669264|NCT01713036|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Unlabeled Pimasertib and Intravenous [14C] Pimasertib||Pre-dose 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 6, 8, 10, 12, 16, 24, and 48 hours post unlabeled pimasertib dose on Day 1; Pre-dose, 0.5, 1, 1.5, 3, 5, 7, 9, 11, 15, 23, and 47 hours post intravenous [14C] labeled pimasertib dose on Day 1|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.||hours||Full Range|Median
669265|NCT01713036|Secondary|Maximum Observed Plasma Concentration (Cmax) of Intravenous [14C] Pimasertib||Pre-dose, 0.5, 1, 1.5, 3, 5, 7, 9, 11, 15, 23, and 47 hours post [14C] intravenous pimasertib dose on Day 1|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.||picogram equivalent per milliliter||95% Confidence Interval|Geometric Mean
669266|NCT01713036|Secondary|Maximum Observed Plasma Concentration (Cmax) of Unlabeled Pimasertib||Pre-dose 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 6, 8, 10, 12, 16, 24, and 48 hours post unlabeled pimasertib dose on Day 1|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.||ng/mL||95% Confidence Interval|Geometric Mean
669267|NCT01713036|Primary|Number of Metabolites Identified Overall and as Major|Identification and profiling of the metabolites was done. The total number of metabolites and the number of metabolites identified as major were reported.|Pre-dose 1.0, 2.0, 4.0, 10 and 24 hours post [14C]-labeled Pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.||metabolites|||Number
669268|NCT01713036|Primary|Plasma Concentrations of Pimasertib Metabolites|Plasma concentration of the Pimasertib metabolite M445 and M554 were presented for the outcome measure.|Predose, 1.0, 2.0, 4.0, 10 and 24 hour post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A. Here 'n' is the number of subjects analysed at each time point.||Nanogram equivalent per milliliter||Standard Deviation|Mean
669269|NCT01713036|Primary|Plasma Concentrations of [14C] Pimasertib||Pre-dose 1.0, 2.0, 4.0, 10 and 24 hours post [14C]-labeled Pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.||nanogram equivalent per milliliter||Standard Deviation|Mean
669270|NCT01713036|Primary|Mass Balance: Amount of Total Radioactivity Recovered Into the Urine and Feces From Time Zero to the Last Sampling Time Point (Ae0-t)|Recovery of total [14C]-radioactivity was determined in excreta, i.e., urine and feces at each sampling period subsequent to oral administration of [14C]-pimasertib on Day 8. Cumulative recovery of total [14C]-radioactivity in terms of percentage of dose recovered in urine and feces and total percentage of dose recovered was reported for the outcome measure.|Urine: 0-4, 4-8, 8-12, 12-24, 24-48, 48-72, and 72-96 hours post [14C]-labeled pimasertib dose on Day 8; Feces: 0-12, 12-24, 24-48, 48-72, 72-96, 96-120, 120-144, and 144-168 hours post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.||percentage of dose recovered||Full Range|Geometric Mean
669271|NCT01713036|Primary|Oral Bioavailability of Pimasertib After Single Oral Dose of Unlabeled Pimasertib and Intravenous (IV) Single Tracer Dose of [14C] Pimasertib|Oral bioavailability (F) was calculated using the formula=AUC0-inf oral/dose oral) / (AUC0-inf iv/dose iv) * 100%, where AUC0-inf is the area under the concentration time curve (AUC) from time zero to infinity.|Pre-dose, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 6, 8, 10, 12, 16, 24, and 48 hours post unlabeled pimasertib dose on Day 1; Pre-dose, 0.5, 1, 1.5, 3, 5, 7, 9, 11, 15, 23, and 47 hours post [14C] labeled pimasertib dose on Day 1|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with investigational medicinal product (IMP) intake for the complete Part A.||percentage bioavailability||90% Confidence Interval|Number
669272|NCT01713036|Primary|Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUC0-inf) of Pimasertib Following Oral Administration on Day 1||Pre-dose, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 6, 8, 10, 12, 16, 24, and 48 hours post unlabeled pimasertib dose on Day 1|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.||hour*nanogram/milliliter||95% Confidence Interval|Geometric Mean
669273|NCT01713036|Primary|Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUC0-inf) of [14C]‐Pimasertib Following IV Administration on Day 1||Pre-dose, 0.5, 1, 1.5, 3, 5, 7, 9, 11, 15, 23, and 47 hours post [14C] intravenous pimasertib dose on Day 1|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.||hour*picogram equivalent/milliliter||95% Confidence Interval|Geometric Mean
669274|NCT01713036|Primary|Area Under the Plasma Concentration Time Curve From Time Zero to the Last Sampling Time Point (AUC0-t) of Pimasertib Following Oral Administration on Day 1||Pre-dose, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 6, 8, 10, 12, 16, 24, and 48 hours post unlabeled pimasertib dose on Day 1|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.||hour*nanogram/milliliter||95% Confidence Interval|Geometric Mean
669275|NCT01713036|Primary|Area Under the Plasma Concentration Time Curve From Time Zero to the Last Sampling Time Point (AUC0-t) of [14C]‐Pimasertib Following Intravenous (IV) Administration on Day 1||Pre-dose, 0.5, 1, 1.5, 3, 5, 7, 9, 11, 15, 23, and 47 hours post [14C] intravenous pimasertib dose on Day 1|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.||hour*picogram equivalent/milliliter||95% Confidence Interval|Geometric Mean
669276|NCT01712984|Secondary|Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route|Solicited injection site: Pain, Erythema, Swelling, Induration, Ecchymosis, and Pruritus; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3 injection site: Pain and Pruritus Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis >100 mm. Grade 3 systemic reactions: Fever ≥39˚C; Headache, Malaise, Myalgia, and Shivering Significant preventing daily activity.|Day 0 up to Day 7 post-vaccination|Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set.||Participants|||Number
670085|NCT01704495|Secondary|Total Number of Days on Oral Cortecosteroids, Due to a Worsening of Asthma Symptoms||From start of treatment up to 6 months|Full analysis set||Days||90% Confidence Interval|Least Squares Mean
669277|NCT01712984|Secondary|Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before (Baseline) and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route|Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay. Seroprotection was defined as titer ≥ 40 [1/dil] at baseline and 28 days after vaccination.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Seroprotection against influenza virus antigens was assessed in the Per Protocol Analysis Set.||Participants|||Number
669278|NCT01712984|Secondary|Geometric Mean Titers Against the Influenza Virus Antigens Before and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route|Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Geometric mean titers against the influenza virus antigens were assessed in the Per Protocol Analysis Set.||Titers||95% Confidence Interval|Geometric Mean
669279|NCT01712984|Primary|Number of Participants With Seroconversion to Influenza Virus Vaccine Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route|Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay. Seroconversion was defined as titer< 10 (1/dil) on Day 0 and post injection titer ≥ 40 (1/dil) on Day 28, or titer ≥10 (1/dil) on Day 0 and a ≥4 fold increase in titer (1/dil) on Day 28).|Day 28 post-vaccination|Seroconversion to the influenza virus antigens were assessed in the Per Protocol Analysis Set.||Participants|||Number
669280|NCT01712984|Primary|Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route|Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay.|Day 28 post-vaccination|Geometric mean titers against the influenza virus antigens were assessed in the Per-protocol Analysis Set.||Titers||95% Confidence Interval|Geometric Mean
669281|NCT01712854|Secondary|Exercise Time in Steady State Exercise|Our secondary objective is to evaluate duration of steady state exercise and exercise capacity before and after treatment. Our secondary hypothesis is that decreases in dynamic hyperinflation during exercise will lead to improvements in dyspnea with exercise, and allow for increases in exercise capacity.|2 hours|The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in February 2013.|||||
669282|NCT01712854|Primary|The Change in Dynamic Hyperinflation Measured by End Expiratory Volumes Recorded by Optoelectronic Plethysmography (OEP).|Our objective is to measure baseline, post treatment and post exercise spirometry and evaluate exercise dynamic hyperinflation before and after treatment using OEP. We hypothesize that budesonide/formoterol fumarate dihydrate will decrease dynamic hyperinflation as measured by OEP.|2 hours|The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in February 2013.|||||
669283|NCT01712776|Primary|Pain Scale on Numeric Rating Scale (NRS) ( 0 to 10)|NRS scale: 0-10 ; No pain (0) - (5) moderate pain - Worst pain (10)|Less than 10 minutes after stream application.|equal numbers in both groups by randomization to 50 in each group to look at NRS by change of 2 in NRS scale between the 2 groups||units on a scale||Standard Deviation|Mean
669284|NCT01712711|Primary|Liver Fat Content Change From Baseline to Six Weeks Post H.Pylori Treatment||8 weeks|||percentage of liver fat content||Standard Deviation|Mean
669285|NCT01712685|Secondary|Kinetic (Ki) Rate Constant|Ki was assessed by the Patlak graphical analysis method which measures the uptake rate constant Ki.|Dynamic imaging was performed for the first 45 minutes post injection and whole body imaging was obtained at 60 minutes post injection. Tumors were surgically excised or biopsied within 4 weeks of imaging.|||1/Minutes||Standard Deviation|Mean
669286|NCT01712685|Secondary|Time to Peak Activity Derived From Time Activity Curve (TAC)|The time to peak activity of radiotracer (tumor marker) uptake indicates the optimal time to image to obtain best tumor visibility.|Dynamic imaging was performed for the first 45 minutes post injection and whole body imaging was obtained at 60 minutes post injection. Tumors were surgically excised or biopsied within 4 weeks of imaging.|||Minutes||Standard Deviation|Mean
669287|NCT01712685|Secondary|Distribution Volume Ratio (DVR) for the Primary Kidney Lesions|DVR of the lesions was measured by the Logan graphical analysis method.|Dynamic imaging was performed for the first 45 minutes post injection and whole body imaging was obtained at 60 minutes post injection. Tumors were surgically excised or biopsied within 4 weeks of imaging.|||Distribution volume ratio||Standard Deviation|Mean
669288|NCT01712685|Secondary|Number of Participants With a Mutation of the Von Hippel-Lindau (VHL) Gene|Germline VHL mutation testing was performed using Clinical Laboratory Improvement Amendments (CLIA) certified laboratories.|21 days prior to enrollment until closure of the study, approximately 14 months.|5/11 participants had germline VHL testing with 4 having identifiable mutations of the VHL gene. 6/11 participants did not have germline VHL mutation testing due to low index of clinical suspicion although 2/6 had germline analysis for other gene mutations linked to familial renal cell carcinoma conditions.||participants|||Number
669289|NCT01712685|Secondary|Mean Standard Uptake Value (SUV) for Normal Kidney|Mean SUV for normal kidney was assessed by lesion based analysis to obtain SUV mean (the average SUV value within the lesion contour).|Dynamic imaging was performed for the first 45 minutes post injection and whole body imaging was obtained at 60 minutes post injection. Tumors were surgically excised or biopsied within 4 weeks of imaging.|||Standard uptake value (SUV||Full Range|Mean
669290|NCT01712685|Secondary|Mean Standard Uptake Value (SUV) for Primary Clear Cell Renal Carcinoma (ccRCC)|Mean SUV for primary clear cell renal carcinoma was assessed by lesion based analysis to obtain SUV mean (the average SUV value within the lesion contour).|Dynamic imaging was performed for the first 45 minutes post injection and whole body imaging was obtained at 60 minutes post injection. Tumors were surgically excised or biopsied within 4 weeks of imaging.|Mean SUV for ccRCC after excluding Bosnial 3 Cyst (e.g. Bosnial 3 complex cyst) in one participant.||Standard uptake value (SUV||Full Range|Mean
669291|NCT01712685|Secondary|Mean Standard Uptake Value (SUV) for All Target Lesions|Mean SUV for all target lesions was assessed by lesion based analysis to obtain SUV mean (the average SUV value within the lesion contour).|Dynamic imaging was performed for the first 45 minutes post injection and whole body imaging was obtained at 60 minutes post injection. Tumors were surgically excised or biopsied within 4 weeks of imaging.|||Standard uptake value (SUV)||Full Range|Mean
669292|NCT01712685|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|58 days|||participants|||Number
669293|NCT01712685|Primary|Level of Uptake of 18F-VM4-037 in Tumor and Non Tumor Tissues, Calculated as Standardized Uptake Values (SUVs)|"The primary outcome measure will be assessed from quantitative measurements (e.g., correlate immunohistochemistry (IHC) results with standardized uptake values (SUVs) from positron emission tomography (PET) images) of the level of uptake of tumor and non tumor tissues into each target lesion, calculated as standardized uptake values. Normal renal parenchyma and muscle are both non-tumor tissue."|58 days|||Standardized uptake value||Standard Error|Mean
669294|NCT01712516|Secondary|Secondary: Change From Baseline in Mean Total Daily Symptom Score, Mean Daytime Total Symptom Score and Mean Nighttime Total Symptom Score|The participant recorded symptom scores twice daily in the eDiary. The daily clinical symptoms included: cough, wheezing, shortness of breath, sputum volume, sputum color, and night time awakening. The range of scores for each assessment is 0 to 3 where 0 indications No symptom and 3 indicates a Severe symptom. The maximum daytime total score is 27 and the maximum nighttime total score is 27. The total daily symptom score is obtained by adding the scores for the morning and evening symptoms for each day. The maximum possible total daily score is 54. A negative change from baseline indicated improvement.|BL, 12 weeks|Full Analysis Set (FAS) The FAS included all randomized participants who received at least one dose of study treatment. Participants, who had both baseline and week 12 values, were included in the analysis.||score on a scale||Standard Error|Least Squares Mean
669295|NCT01712516|Secondary|Secondary: Change From Baseline in Mean Daily Number of Puffs of Rescue Medication|Participants completed an electronic diary (eDiary) twice daily at the same time in the morning and evening to record the number of puffs of rescue medication taken in the previous 12 hours. A negative change from baseline indicates improvement.|BL, 12 weeks|Full Analysis Set (FAS) The FAS included all randomized participants who received at least one dose of study treatment. Participants, who had both baseline and week 12 values, were included in the analysis.||number of puffs||Standard Error|Least Squares Mean
669296|NCT01712516|Secondary|Transitional Dyspnea Index (TDI) Focal Score|The Baseline Dyspnea Index (BDI) / TDI is an instrument used to assess a participant's level of dyspnea. The BDI and TDI each have three domains: functional impairment, magnitude of task and magnitude of effort. BDI domains were rated from 0 (severe) to 4 (unimpaired) and rates summed for baseline focal score ranged from 0 to 12; lower scores mean worse severity. TDI domains were rated from -3 (major deterioration) to 3 (major improvement) and rates summed for transition focal score ranged from -9 to 9; negative scores indicate deterioration. A TDI focal score of ≥1 was defined as a clinically important improvement from baseline.|BL, 12 weeks|Full Analysis Set (FAS) The FAS included all randomized participants who received at least one dose of study treatment. Participants, who had both baseline and week 12 scores, were included in the analysis.||score on a scale||Standard Error|Least Squares Mean
669297|NCT01712516|Secondary|Secondary: Change From Baseline in Standardized FEV1 AUC (0-4 h), FEV1 AUC (4-8h), FEV1 AUC (8-12h) and FEV1 AUC (0-12 h)|Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction. The trapezoidal rule was used to calculate FEV1 AUC and then normalized to the length of time.|BL, day 1, 12 weeks|Full Analysis Set: The FAS included all randomized participants who received at least one dose of study treatment. Participants, who had both baseline and post baseline values for a given time point, were included in the analysis for that time point.||Liters||Standard Error|Least Squares Mean
669298|NCT01712516|Secondary|Change From Baseline in FVC|Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FVC was defined as the average of the pre-dose FVC measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FVC measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction.|BL, Day 1: 5min, 15min, 1h, 2h, 4h, 6h, 8h, 11h55 min; Day 2: 23h15min, 23h45min; Day 15: -45min, -15min, 1h; Day 29: -45 min, -15min, 1h; Day 57: -45min, -15min, 1h; day 85: -45min, -15min, 5min, 15min, 1h, 2h, 4h, 6h, 8h, 11h; day 86: 23h15min; 23h45min|Full Analysis Set (FAS): The FAS included all randomized participants who received at least one dose of study medication. Participants, who has both baseline and post baseline values for a given time point, were included in the analysis for that time point.||Liters||Standard Error|Least Squares Mean
669299|NCT01712516|Secondary|Change From Baseline in FEV1|Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction.|BL, Day 1: 5min, 15min, 1h, 2h, 4h, 6h, 8h, 11h55 min; Day 2: 23h15min, 23h45min; Day 15: -45min, -15min, 1h; Day 29: -45 min, -15min, 1h; Day 57: -45min, -15min, 1h; day 85: -45min, -15min, 5min, 15min, 1h, 2h, 4h, 6h, 8h, 11h; day 86: 23h15min; 23h45min|Full Analysis Set (FAS): The FAS included all randomized participants who received at least one dose of study medication. Participants, who has both baseline and post baseline values for a given time point, were included in the analysis for that time point.||Liters||Standard Error|Least Squares Mean
669351|NCT01712074|Other Pre-specified|Blood Pressure (BP) Changes From Baseline - Week 6 (Visit 3)|The BP changes from baseline at Week 6 (Visit 3) including supine systolic BP, standing systolic BP, standing systolic BP, supine diastolic BP, standing diastolic BP.|Baseline and Week 6|All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)||millimeters of mercury (mm Hg)||Full Range|Mean
669300|NCT01712516|Secondary|Change From Baseline in Pre-dose Trough FEV1|Pulmonary function assessments were performed using centralized spirometry according to international standards. Pre-dose trough FEV1 was analyzed using the same MMRM as specified for FEV1. Pre-dose trough FEV1 was defined as the mean of FEV1 at -45 min and -15 min before the morning dose. Since the time of evening dose of the previous day was not recorded at these visits, no time window was applied.|BL, day 85|Full Analysis Set (FAS): The FAS included all randomized participants who received at least one dose of study treatment. Participants, who had both baseline and week 12 values, were included in the analysis.||Liters||Standard Error|Least Squares Mean
669301|NCT01712516|Secondary|Change From Baseline in Trough FEV1|Pulmonary function assessments were performed using centralized spirometry according to international standards. Trough FEV1 was analyzed using the same MMRM as specified for FEV1. Trough FEV1 was defined as the mean of FEV1 at 23 h 15 min and 23 h 45 min after the morning dose of the previous day. Before the mean was calculated, a time window of 10 – 13 hours post-evening dose was applied to these 2 measurements. Recordings outside the time window were set to missing.|BL, day 2, day 86|Full Analysis Set (FAS): The FAS included all randomized participants who received at least one dose of study treatment. Participants, who had both baseline and post baseline values for a given time point, were included in the analysis for that time point.||Liters||Standard Error|Least Squares Mean
669302|NCT01712516|Secondary|Percentage of Participants With a Clinically Important Improvement of at Least 4 Units in the SGRQ Total Score|"Participants reported change in health status by using the SGRQ. The SGRQ contains 50 items divided into 2 parts covering 3 aspects of health related to COPD: Part I covers Symptoms and is concerned with respiratory symptoms, their frequency and severity; Part II covers Activity and is concerned with activities that cause or are limited by breathlessness; Part II is also concerned with Impacts, which covers a range of aspects concerned with social functioning and psychological disturbances resulting from airways disease. A score was calculated for each of these 3 subscales and a Total score was calculated. In each case the lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status."|12 weeks|Participants from the full analysis set, who had a SGRQ total score, were included in the analysis. The full analysis set included all randomized participants who received at least one dose of study treatment.||Percentage of participants|||Number
669303|NCT01712516|Secondary|Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score|"Participants reported change in health status by using the SGRQ. The SGRQ contains 50 items divided into 2 parts covering 3 aspects of health related to COPD: Part I covers Symptoms and is concerned with respiratory symptoms, their frequency and severity; Part II covers Activity and is concerned with activities that cause or are limited by breathlessness; Part II is also concerned with Impacts, which covers a range of aspects concerned with social functioning and psychological disturbances resulting from airways disease. A score was calculated for each of these 3 subscales and a Total score was calculated. In each case the lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status. Missing week 12 data were imputed with Last Observation Carried Forward (LOCF) method but only if measured at day >= 29. A negative change from baseline indicates improvement."|BL, 12 Weeks|Full Analysis Set: The full analysis set included all randomized participants who received at least one dose of study treatment. Participants missing week 12 data were not included in the analysis.||score on a scale||Standard Error|Least Squares Mean
669304|NCT01712516|Primary|Primary: Change From Baseline in Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) (0-12 Hours (h))|Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction. Missing values of FEV1 AUC0-12 at Day 1 and Week 12 will not imputed. The trapezoidal rule was used to calculate FEV1 AUC and then normalized to the length of time.|baseline (BL), 12 weeks|Full Analysis Set: The full analysis set included all randomized participants who received at least one dose of study treatment. Participants, who were missing day 1 and/or week 12 FEV1 AUC 0-12h measurements, were not included in the analysis.||Liters||Standard Error|Least Squares Mean
669305|NCT01712399|Primary|Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)|DLCO is a pulmonary function testing that measures partial pressure difference between inspired and expired carbon monoxide.|From Week 12 to Week 156 at specified time points|The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W. Here 'n' represents those participants who were evaluable for this measure at given time points.||(mL/min/mmHg)||Standard Deviation|Mean
669306|NCT01712399|Primary|Oxygen Saturation Levels by Pulse Oximetry|Oxygen saturation measured by pulse oximetry which measures the concentration of oxygen in the blood.|From Week 0 to Week 132 at specified time points|The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W. Here 'n' represents those participants who were evaluable for this measure at given time points.||Percent saturation||Standard Error|Mean
669307|NCT01712399|Primary|Number of Participants With Clinically Meaningful Change in Borg Dyspnea Score Considered as an AE|Borg dyspnea score was a validated participant reported outcome assessing participant’s perceived difficulty in breathing (dyspnea). The score ranges from 0 (nothing at all) to 10 (maximal difficulty). Higher scores indicated greater difficulty in breathing.|From Week 0 to Week 132 at specified time points|The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W.||Participants|||Number
669308|NCT01712399|Primary|Number of Participants With Forced Vital Capacity (FVC) Outside Threshold Values|Pulmonary function testing was performed by spirometry to assess forced vital capacity (FVC). FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. The percentage of predicted values of these pulmonary function tests were calculated based on decrease from baseline and categorized as =<15% reduction from baseline, >15% to =<20% reduction from baseline, >20% reduction from baseline and >20% reduction to <80%. The threshold values refer to baseline values for each participant.|From Week 24 to Week 156 at specified time points|The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W. Here 'n' represents those participants who were evaluable for this measure at given time points.||Participants|||Number
669309|NCT01712399|Primary|Number of Participants With Forced Expiratory Volume in 6 Seconds (FEV6) Outside Threshold Values|Pulmonary function testing was performed by spirometry to assess forced expiratory volume in 6 seconds (FEV6). FEV6 was the maximal volume of air exhaled in the six second of a forced expiration from a position of full inspiration. The percentage of predicted values of these pulmonary function tests were calculated based on decrease from baseline and categorized as =<15% reduction from baseline, >15% to =<20% reduction from baseline, >20% reduction from baseline and >20% reduction to <80%. The threshold values refer to baseline values for each participant.|From Week 24 to Week 130 at specified time points|The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W. Here 'n' represents those participants who were evaluable for this measure at given time points.||Participants|||Number
669310|NCT01712399|Primary|Number of Participants With Forced Expiratory Volume in 1 Second (FEV1) Outside Threshold Values|Pulmonary function testing was performed by spirometry to assess forced expiratory volume in 1 second (FEV1). FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration.The percentage (%) of predicted values of these pulmonary function tests were calculated based on decrease from baseline and categorized as less than or equal to (=<)15% reduction from baseline, greater than (>)15% to =<20% reduction from baseline, >20% reduction from baseline and >20% reduction to <80%. The threshold values refer to baseline values for each participant.|From Week 24 to Week 130 at specified time points|The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W. Here 'n' represents those participants who were evaluable for this measure at given time points.||Participants|||Number
669311|NCT01712399|Primary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings Reported as TEAEs|The 12-lead ECG data were summarized and evaluated. TEAEs related to abnormal ECG findings were recorded and reported. TEAEs were defined as AEs with onset date after the first dose of mavrilimumab 100 mg.|From the start of study drug administration in the study up to 12 weeks after the last dose of study drug (approximately up to 3 years)|The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W.||Participants|||Number
669312|NCT01712399|Primary|Number of Participants With Vital Sign Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)|Vital sign assessments included blood pressure, pulse rate, temperature, weight and respiration rate. Vital sign abnormalities recorded as TEAEs were reported. TEAEs were defined as AEs with onset date after the first dose of mavrilimumab 100 mg.|From the start of study drug administration in the study up to 12 weeks after the last dose of study drug (approximately up to 3 years)|The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W.||Participants|||Number
669313|NCT01712399|Primary|Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)|Laboratory parameters included hematology, serum chemistry and urinalysis recorded as TEAEs. Clinical laboratory abnormalities recorded as TEAEs were reported.TEAEs were defined as AEs with onset date after the first dose of mavrilimumab 100 mg.|From the start of study drug administration in the study up to 12 weeks after the last dose of study drug (approximately up to 3 years)|The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W.||Participants|||Number
669314|NCT01712399|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received investigational product. A serious adverse event (SAE) was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were defined as AEs with onset date after the first dose of mavrilimumab 100 mg.|From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)|The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W.||Participants|||Number
669315|NCT01712360|Secondary|Efficacy Variables|"Efficacy variables to be analyzed after 2 weeks of once daily application of both products (NAFT-500 or NAFT-600).
Efficacy variables to be analyzed:
- Subject satisfaction"|Day 28|Full analysis set, defined as subset of subjects in the safety evaluation set (SES) for whom any efficacy variable is available.||Percentage (%) of subjects|||Number
669316|NCT01712360|Primary|Naftifine Hydrochloride Pharmacokinetics Variables, Single and Multiple Dose|"Variables will be derived from naftifine plasma concentration at day 1. Variables to be analyzed:
- Maximum observed plasma concentration (Cmax): the highest plasma concentration in each subject after single dose.
Variables will be derived from naftifine plasma concentration at day 14. Variables to be analyzed:
- Maximum observed plasma concentration (Cmax): the highest plasma concentration in each subject at steady state (SS)."|Day 1 and Day 14|Pharmacokinetic analysis set (PKS), defined as the subset of subjects in safety evaluation set (SES) with evaluable pharmacokinetic (PK) samples.||pg/mL||Geometric Coefficient of Variation|Geometric Mean
669317|NCT01712360|Secondary|Efficacy Variables|"Efficacy variables to be analyzed after 2 weeks of once daily application of both products (NAFT-500 or NAFT-600).
Efficacy variables to be analyzed:
Complete cure
Treatment effectiveness
Mycological cure
Clinical success
Clinical cure"|Day 28|Full analysis set, defined as subset of subjects in the safety evaluation set (SES) for whom any efficacy variable is available.||Percentage (%) of subjects (90% CI)||90% Confidence Interval|Number
669318|NCT01712360|Primary|Naftifine Hydrochloride Pharmacokinetics Variables, Single and Multiple Dose|"Variables will be derived from naftifine plasma concentration at day 1. Variables to be analyzed:
- Partial area under the plasma concentration-time curve (0-24 hours postdose) (AUC), as calculated using the linear trapezoid rule.
Variables will be derived from naftifine plasma concentration at day 14. Variables to be analyzed:
- Area under the plasma concentration-time curve (AUC) within one dosing interval at steady state (SS). AUCτ,ss= Area under the concentration curve within a dosing interval (τ = 24 hours) at steady state"|Day 1 and Day 14|Pharmacokinetic analysis set (PKS), defined as the subset of subjects in the safety evaluation set (SES) with evaluable pharmacokinetic (PK) samples.||h*pg/mL||Geometric Coefficient of Variation|Geometric Mean
669659|NCT01709708|Secondary|Change in Numeric Rating Scale (NRS)|Compare change in Numeric Rating Scale (NRS) score from Before Procedure to 15-Minutes, Before Procedure to 30-Minutes, Before Procedure to 24-Hours After Procedure for all 12 treatments (Group A vs. Group B). NRS is a likert scale ranging from 0-10 with 0 being no pain and 10 being worst possible pain.|Estimated 6 Weeks||||||
669319|NCT01712334|Primary|Safety: Number of Participants With Adverse Events During Each Treatment Period|An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events.|4 Weeks|Safety population included all randomized participants who received treatment.||participants|||Number
669320|NCT01712334|Primary|Stability of Lung Function: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1)|Spirometry was performed according to American Thoracic Society standards. FEV1 is the amount of air that is forced out of the lungs in one second and was measured at the end of each 2-week treatment period. The percent predicted FEV1 was calculated as: Percent predicted FEV1 =FEV1 (L) / Predicted FEV1 (L) ×100.|At the end of each 2-week treatment period|Modified Intent-to-Treat (mITT) population included all randomized participants with baseline and endpoint FEV1 values for both treatment periods.||percent predicted||Standard Deviation|Mean
669321|NCT01712256|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|To evaluate the safety and tolerability of re-boosting with Vacc-4x by number of participants with Adverse Events|37 weeks|||participants|||Number
669322|NCT01712256|Secondary|Delayed Type Hypersensitivity Test (DTH), Positive Responses for Erythema|The proportion of subjects who show Delayed Type Hypersensitivity (DTH) during the treatment phase.|4 Weeks|"The ITT includes 30 subjects (3 did not receive ART from Scr. through Week 12) and the PP includes 27 (an additional 3 did not discontinue ART at Week 12).
Due to the influence of ART on efficacy endpoints, certain subjects or part of their data were excluded from the full ITT and PP, based on when they were on or off ART during the study."||participants|||Number
669323|NCT01712256|Secondary|Delayed Type Hypersensitivity Test (DTH), Positive Responses for Induration|The proportion of subjects who show Delayed Type Hypersensitivity (DTH) during the treatment phase.|4 weeks|"The ITT includes 30 subjects (3 did not receive ART from Scr. through Week 12) and the PP includes 27 (an additional 3 did not discontinue ART at Week 12).
Due to the influence of ART on efficacy endpoints, certain subjects or part of their data were excluded from the full ITT and PP, based on when they were on or off ART during the study."||participants|||Number
669324|NCT01712256|Secondary|Vacc-4x Effect on Immune Response Measured as CD8 Count|Effect of Re-boost with Vacc-4x on immune response obtained following immunization with Vacc-4x in Study CT-BI Vacc-4x 2007/1|36 weeks|"The ITT includes 30 subjects (3 did not receive ART from Scr. through Week 12) and the PP includes 27 (an additional 3 did not discontinue ART at Week 12).
Due to the influence of ART on efficacy endpoints, certain subjects or part of their data were excluded from the full ITT and PP, based on when they were on or off ART during the study."||cells/micro liter||Standard Deviation|Mean
669325|NCT01712256|Secondary|Vacc-4x Effect on Immune Response Measured as CD4 Count|Effect of Re-boost with Vacc-4x on immune response obtained following immunization with Vacc-4x in Study CT-BI Vacc-4x 2007/1|36 weeks|"The ITT includes 30 subjects (3 did not receive ART from Scr. through Week 12) and the PP includes 27 (an additional 3 did not discontinue ART at Week 12).
Due to the influence of ART on efficacy endpoints, certain subjects or part of their data were excluded from the full ITT and PP, based on when they were on or off ART during the study."||cells/micro liter||Standard Deviation|Mean
669326|NCT01712256|Primary|Vacc-4x Effect on Viral Load Set-point|Viral load (VL) set point in the present re-boost study was compared with VL set point in the 2007/1 study.|37 weeks|In the ITT population there were 20 evaluable subjects out of 30 (3 subjects did not receive ART from Screening through Week 12) and in the PP population there were 18 evaluable subjects out of 27 (an additional 3 subjects did not discontinue ART at Week 12).||Copies/mL||Standard Deviation|Mean
669327|NCT01712204|Other Pre-specified|Mean Pain Visual Analog Scale Score Associated With Gout Flares||16 weeks||||||
669328|NCT01712204|Secondary|Proportion of Subjects Achieving Serum Uric Acid Concentration <6.0 or <5.0 mg/dL||16 weeks||||||
669329|NCT01712204|Secondary|Change From Baseline in Serum Uric Acid Concentration||16 weeks||||||
669330|NCT01712204|Secondary|Duration of Gout Flares||16 weeks||||||
669331|NCT01712204|Secondary|Gout Flare Days Per Subject||16 weeks||||||
669332|NCT01712204|Secondary|Time to First Gout Flare||16 weeks||||||
669333|NCT01712204|Secondary|Proportion of Subjects Experiencing ≥1 or ≥2 Gout Flares||16 weeks||||||
669334|NCT01712204|Primary|Number of Gout Flares Per Subject||16 weeks|||flares||95% Confidence Interval|Least Squares Mean
669335|NCT01712178|Secondary|Mean Injection Site Pain on a Visual Analogue Scale (VAS)|The Visual Analogue Scale (VAS) consisted of a horizontal 100 mm line, with 0 representing “no pain” and 100 representing “worst possible pain”. Participants placed a mark on the line representing their current level of pain immediately after injections on Day 1 of the study.|Immediately after injections on Day 1|||Millimeters||Standard Deviation|Mean
669336|NCT01712178|Secondary|Number of Participants With Adverse Events|An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which did not necessarily have a causal relationship with the treatment. See the Reported Adverse Events Section for more details.|From time of informed consent to 70 days following the last dose of study drug|||participants|||Number
669337|NCT01712178|Secondary|Percentage of Participants Positive for Anti-adalimumab Antibody|Percentage of participants with anti-adalimumab antibody|Measured through Week 24|||Percentage of participants|||Number
669338|NCT01712178|Secondary|Mean Short Form-36 (SF-36) Physical Component Summary Scores and Mental Component Summary Scores at Weeks 12 and 24|The Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 (maximum disability) - 100 (no disability). The standard recall period is four weeks.|Measured at Weeks 12 and 24|All available data were included. If a subject did not have a value for a given time of evaluation, but did have a value at times previous to this after the study drug treatment began, the last available value was used to replace the missing value.||units on a scale||Standard Error|Least Squares Mean
669339|NCT01712178|Secondary|Mean Health Assessment Questionnaire (HAQ-DI) Scores at Weeks 12 and 24|The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. The minimal clinically important difference (MCID) defined for the HAQ-DI is ≥0.22. HAQ remission indicating normal physical function is defined by HAQ-DI < 0.5.|Measured at Weeks 12 and 24|All available data were included. If a subject did not have a value for a given time of evaluation, but did have a value at times previous to this after the study drug treatment began, the last available value was used to replace the missing value.||units on a scale||Standard Error|Least Squares Mean
669340|NCT01712178|Secondary|Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Weeks 12 and 24|"American College of Rheumatology 50% (ACR50) response. A participant is a responder if the following 3 criteria for improvement from baseline are met:
≥ 50% improvement in tender joint count;
≥ 50% improvement in swollen joint count; and
≥ 50% improvement in at least 3 of the 5 following parameters:
Physician global assessment of disease activity
Patient global assessment of disease activity
Patient assessment of pain
Disability Index of the Health Assessment Questionnaire
CRP (Acute phase reactant (Erythrocyte sedimentation rate/C-reactive protein))"|Measured at Weeks 12 and 24|All available data were included. If a subject did not have a value for a given time of evaluation, but did have a value at times previous to this after the study drug treatment began, the last available value was used to replace the missing value.||percentage of participants|||Number
669341|NCT01712178|Secondary|Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Weeks 12 and 24|"American College of Rheumatology 20% (ACR20) response. A participant is a responder if the following 3 criteria for improvement from baseline are met:
≥ 20% improvement in tender joint count;
≥ 20% improvement in swollen joint count; and
≥ 20% improvement in at least 3 of the 5 following parameters:
Physician global assessment of disease activity
Patient global assessment of disease activity
Patient assessment of pain
Disability Index of the Health Assessment Questionnaire
CRP (Acute phase reactant (Erythrocyte sedimentation rate/C-reactive protein))"|Measured at Weeks 12 and 24|All available data were included. If a subject did not have a value for a given time of evaluation, but did have a value at times previous to this after the study drug treatment began, the last available value was used to replace the missing value.||percentage of participants|||Number
669342|NCT01712178|Primary|Mean Disease Activity Scores (DAS28) at Weeks 12 and 24|The Disease Activity Score (DAS28) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.|Measured at Weeks 12 and 24|All available data were included. If a subject did not have a value for a given time of evaluation, but did have a value at times previous to this after the study drug treatment began, the last available value was used to replace the missing value.||units on a scale||Standard Error|Least Squares Mean
669343|NCT01712178|Primary|Serum Concentrations of Adalimumab at Weeks 12 and 24|Blood samples for adalimumab analysis were collected by venipuncture and serum concentrations of adalimumab were determined using a validated enzyme-linked immunoadsorbent assay (ELISA) method.|Measured at Weeks 12 and 24|Data from participants receiving the new formulation of adalimumab were analyzed for 46 and 47 participants, respectively, at weeks 12 and 24. Data for the participants receiving the current formulation of adalimumab were analyzed for 43 participants at week 12 and 41 participants at week 24.||µg/mL||Standard Deviation|Mean
669344|NCT01712074|Other Pre-specified|Participants in Each Category of C-CASA Mapped From the C-SSRS Responses|"Participants in each category of the Columbia Classification Algorithm of Suicide Assessment (C-CASA) mapped from the Columbia-Suicide Severity Rating Scale (C-SSRS) responses were reported.
C-CASA Event Code: <1> Completed suicide; <2> Suicide attempt; <3> Preparatory acts towards imminent suicidal behavior; <4> Suicidal Ideation; <7> Self-injurious behavior, no suicidal intent.
The suicidality assessments were performed at Screening, Week 0 (Visit 1), Week 4 (Visit 2), Week 6, (Visit 3), Week 10 (Visit 4), Week 16 (Visit 5), and Week 18 (Visit 6).
Only participants falling any category of C-CASA events were listed below."|From Screening to Week 18/Early Termination|All participants screened and assigned||Participants|||Number
669345|NCT01712074|Other Pre-specified|Proportion of Participants With Post-Baseline Vital Signs Abnormalities of Potential Clinical Concern|Proportion (%) of participants with vital signs abnormalities (absolute and change from baseline) meeting categorical criteria over the 12-week double blind treatment period were counted. Vital signs data included blood pressure (BP) and pulse rate.|Week 4 to Week 16|All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)||Percentage of Participants|||Number
669346|NCT01712074|Other Pre-specified|Pulse Rate Changes From Baseline - Week 16/Early Termination (Visit 5)|The pulse rate changes from baseline at Week 16/Early Termination (Visit 5) including supine pulse rate, and standing pulse rate.|Baseline and Week 16/Early Termination|All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)||bpm||Full Range|Mean
669347|NCT01712074|Other Pre-specified|BP Changes From Baseline - Week 16/Early Termination (Visit 5)|The BP changes from baseline at Week 16/Early Termination (Visit 5) including supine systolic BP, standing systolic BP, standing systolic BP, supine diastolic BP, standing diastolic BP.|Baseline and Week 16/Early Termination|All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)||mmHg||Full Range|Mean
669348|NCT01712074|Other Pre-specified|Pulse Rate Changes From Baseline - Week 10 (Visit 4)|The pulse rate changes from baseline at Week 10 (Visit 4) including supine pulse rate, and standing pulse rate.|Baseline and Week 10|All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)||bpm||Full Range|Mean
669349|NCT01712074|Other Pre-specified|BP Changes From Baseline - Week 10 (Visit 4)|The BP changes from baseline at Week 10 (Visit 4) including supine systolic BP, standing systolic BP, standing systolic BP, supine diastolic BP, standing diastolic BP.|Baseline and Week 10|All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)||mmHg||Full Range|Mean
669352|NCT01712074|Other Pre-specified|Proportion of Participants With QTcF Interval Abnormalities of Potential Clinical Concern|"Proportion (%) of participants with QTcF Interval abnormalities meeting categorical criteria over the 12-week double blind treatment period. The QTcF interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle, which is corrected for heart rate using Fridericia's formula.
Participants with a post-baseline QTcF absolute value of 450 - <480, 480 - <500, or >=500 mec, or with a post-baseline QTcF increase of 30 - <60 or >=60 msec were counted."|Week 4 to Week 16|All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)||Percentage of Participants|||Number
669353|NCT01712074|Other Pre-specified|Selected ECG Change From Baseline - QTcF Interval at Week 16/Early Termination (Visit 5)|The QTcF interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle, which is corrected for heart rate using Fridericia's formula.|Baseline and Week 16/Early Termination|All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)||msec||Full Range|Mean
669354|NCT01712074|Other Pre-specified|Selected ECG Change From Baseline - QTcF Interval at Week 10 (Visit 4)|The QTcF interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle, which is corrected for heart rate using Fridericia's formula.|Baseline and Week 10|All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)||msec||Full Range|Mean
669355|NCT01712074|Other Pre-specified|Selected ECG Change From Baseline - QTcF Interval at Week 6 (Visit 3)|The QTcF interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle, which is corrected for heart rate using Fridericia's formula.|Baseline and Week 6|All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)||msec||Full Range|Mean
669356|NCT01712074|Other Pre-specified|Proportion of Participants With QRS Complex Abnormalities of Potential Clinical Concern|Proportion (%) of participants with QRS Complex abnormalities meeting categorical criteria over the 12 week double blind treatment period. The QRS complex is the combination of the Q wave, R wave and S wave, representing ventricular depolarization). Participants with post-baseline QRS complex absolute value>=100 msec , a QRS complex increase of >=25% (for participants with a baseline value>=100 msec), or with an increase >=50% (for participants with a baseline value<100 msec) were counted.|Week 4 to Week 16|All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)||Percentage of participants|||Number
669357|NCT01712074|Other Pre-specified|Selected ECG Change From Baseline - QRS Complex at Week 16/Early Termination (Visit 5)|The QRS complex is the combination of the Q wave, R wave and S wave, representing ventricular depolarization.|Baseline and Week 16/Early Termination|All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)||msec||Full Range|Mean
669358|NCT01712074|Other Pre-specified|Selected ECG Change From Baseline - QRS Complex at Week 10 (Visit 4)|The QRS complex is the combination of the Q wave, R wave and S wave, representing ventricular depolarization.|Baseline and Week 10|All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)||msec||Full Range|Mean
669359|NCT01712074|Other Pre-specified|Selected ECG Change From Baseline - QRS Complex at Week 6 (Visit 3)|The QRS complex is the combination of the Q wave, R wave and S wave, representing ventricular depolarization.|Baseline and Week 6|All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)||msec||Full Range|Mean
669360|NCT01712074|Other Pre-specified|Percentage of Participant With PR Interval Abnormalities of Potential Clinical Concern|Proportion (%) of participants with PR Interval abnormalities meeting categorical criteria over the 12 week double blind treatment period. The PR interval is the time from the onset of the P wave to the start of the QRS complex (the combination of the Q wave, R wave and S wave, representing ventricular depolarization). Participants with post-baseline PR absolute value>=300 msec , a PR increase of >=25% (for participants with a baseline value>=200 msec), or with an increase >=50% (for participants with a baseline value<200 msec) were counted.|Week 4 to Week 16|All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)||Percentage of Participants|||Number
669361|NCT01712074|Other Pre-specified|Selected ECG Change From Baseline - PR Interval at Week 16/Early Termination (Visit 5)|The PR interval is the time from the onset of the P wave to the start of the QRS complex (the combination of the Q wave, R wave and S wave, representing ventricular depolarization).|Baseline and Week 16/Early Termination|All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)||msec||Full Range|Mean
669362|NCT01712074|Other Pre-specified|Selected ECG Change From Baseline - PR Interval at Week 10 (Visit 4)|The PR interval is the time from the onset of the P wave to the start of the QRS complex (the combination of the Q wave, R wave and S wave, representing ventricular depolarization).|Baseline and Week 10|All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)||msec||Full Range|Mean
669363|NCT01712074|Other Pre-specified|Selected ECG Change From Baseline - PR Interval at Week 6 (Visit 3)|The PR interval is the time from the onset of the P wave to the start of the QRS complex (the combination of the Q wave, R wave and S wave, representing ventricular depolarization).|Baseline and Week 6|All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)||milliseconds (msec)||Full Range|Mean
669364|NCT01712074|Other Pre-specified|Proportion of Participants With Laboratory Abnormalities of Potential Clinical Concern During Double Blind Period|"Proportion (%) of participants with laboratory abnormalities (without regard to baseline abnormalities) of potential clinical concern over the 12-week double blind treatment period.
The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen, creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, bilirubin, alkaline phosphatase, uric acid, albumin, and total protein; urinalysis (pH, glucose, protein/albumin, hemoglobin/blood, ketones/acetone, nitrites, leukocyte esterase, microscopy [if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase]); others (only at screening or needed: urine drug screen, thyroid panel, Vitamin B12, methylmalonic acid, folate and Hemoglobin A1)."|Week 4 to Week 16|All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)||Percentage of Participants|||Number
670061|NCT01704495|Secondary|Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Asthma Control Days||Baseline (last 14 days before randomization) and Treatment Period (Days 85 to 6 months|Full Analysis set||asthma control days||90% Confidence Interval|Least Squares Mean
669365|NCT01712074|Other Pre-specified|Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Discontinuation|Proportion of participants with TEAEs leading to discontinuation over the 12-week double blind treatment period and washout. Adverse events (AEs) occurring following start of treatment or increasing in severity were counted as treatment emergent|Week 4 to Week 18|All participants who received any treatment during double blind period||Percentage of Participants|||Number
669366|NCT01712074|Secondary|Change From Baseline in the Neuropsychiatric Inventory (NPI) Total Score at Week 16 (Visit 5)|The NPI evaluates both frequency and severity of 12 neuropsychiatric disturbances including delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, nighttime behaviors, as well as appetite/eating. The NPI total score (for 12 behavioral domains) is calculated as the product of frequency and severity for each domain, and ranges from 0 to 144. An increase in score indicates a worsening of symptoms.|Baseline and Week 16|The FAS is defined as all participants who are randomized. The FAS was the primary analysis set for efficacy data.||scores on a scale||Standard Error|Least Squares Mean
669367|NCT01712074|Primary|Change From Baseline in ADAS-cog13 Total Score at Week 16|ADAS-cog13 (13-item ADAS cog) is a psychometric instrument that evaluates word recall, ability to follow commands, constructional praxis, naming, ideational praxis, orientation, word recognition, memory, comprehension of spoken language, word-finding, and language ability, with a measure of delayed word recall and concentration/ distractibility. The total score of the 13-item scale ranges from 0 to 85, with an increase in score indicating cognitive worsening.|Baseline and Week 16|The Full Analysis Set (FAS) is defined as all participants who were randomized. The FAS was the primary analysis set for efficacy data.||scores on a scale||Standard Error|Least Squares Mean
669368|NCT01712061|Other Pre-specified|Number of Participants With Increased Fasting Blood Glucose||Baseline up to Week 16 (follow-up visit)|The Safety Analysis Set is defined as all participants who receive at least 1 dose of study medication; number of participants analyzed (N) is number of evaluable participants for this outcome measure.||participants|||Number
669369|NCT01712061|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of treatment and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-serious AEs.|Baseline up to 28 days after last study drug administration|The Safety Analysis Set is defined as all participants who receive at least 1 dose of study medication.||participants|||Number
669370|NCT01712061|Other Pre-specified|Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings|Criteria for potentially clinically important ECG values were defined as: PR interval >=300 milliseconds (msec) or >=25%/50% increase when baseline is >200 msec and ≥50% increase when baseline is less than or equal to (<=)200 msec; QRS interval >=140 msec or >=50% increase from baseline (IFB); QTc >=450 msec or >=30 msec increase; corrected QT interval using Fridericia's formula (QTcF) >=450 msec or >=30 msec increase.|Baseline, Weeks 1, 4 and 12|The Safety Analysis Set is defined as all participants who receive at least 1 dose of study medication; n=number of participants analyzed in respective arms for category.||participants|||Number
669371|NCT01712061|Other Pre-specified|Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern|The following laboratory parameters were analyzed for abnormalities at any time point mentioned in the timeframe: clinical chemistry (sodium, potassium, chloride, bicarbonate, phosphate, glucose, blood urea nitrogen [BUN], creatinine, albumin, calcium, bilirubin [total, direct, and indirect], gamma-glutamyl transferase [GGT], alanine aminotransferase [ALT], aspartate aminotransferase [AST], lactic dehydrogenase [LDH], alkaline phosphatase, creatine phosphokinase [CPK], uric acid, amylase and lipase); hematology (hemoglobin, hematocrit, red blood cell [RBC] count, white blood cell [WBC] count with differential, and platelet count); FSH (for postmenopausal women who had been amenorrheic for less than 2 years prior to screening).|Baseline up to Week 16 (follow-up visit)|The Safety Analysis Set is defined as all participants who receive at least 1 dose of study medication; number of participants analyzed (N) is number of evaluable participants for this outcome measure.||participants|||Number
669372|NCT01712061|Other Pre-specified|Change From Baseline in Body Weight at Weeks 1, 4, 8, 12 and 16||Baseline, Weeks 1, 4, 8, 12 and 16|The Safety Analysis Set is defined as all participants who receive at least 1 dose of study medication; n=number of participants analyzed in respective arms for category.||kilograms (kg)||Standard Deviation|Mean
669373|NCT01712061|Other Pre-specified|Change From Baseline in Pulse Rate at Weeks 1, 4, 8, 12 and 16||Baseline, Weeks 1, 4, 8, 12 and 16|The Safety Analysis Set is defined as all participants who receive at least 1 dose of study medication; n=number of participants analyzed in respective arms for category.||beats per minute (bpm)||Standard Deviation|Mean
669374|NCT01712061|Other Pre-specified|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 1, 4, 8, 12 and 16||Baseline, Weeks 1, 4, 8, 12 and 16|The Safety Analysis Set is defined as all participants who receive at least 1 dose of study medication; n=number of participants analyzed in respective arms for category.||millimeters of mercury (mm Hg)||Standard Deviation|Mean
669375|NCT01712061|Secondary|Summary of Plasma PF-04634817 Pharmacokinetic (PK) Concentrations at Day 1 and Weeks 1, 4, 8 and 12||1, 2, 4 hours post-dose on Day 1; 2 hours post-dose on Weeks 1, 4, 8 and 12|The PK Concentration Analysis Set is defined as all participants in the FAS for whom a PK sample was obtained and analyzed; n=number of participants analyzed in respective arms for category.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
669376|NCT01712061|Secondary|Change From Baseline in Plasma Glycosylated Hemoglobin (HbA1c) at Weeks 4, 8, 12 and 16|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. As the average amount of plasma glucose increases, the fraction of HbA1c increases in a predictable way.|Baseline, Weeks 4, 8, 12 and 16|The FAS was defined as all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 post-dose efficacy measurement; n=number of participants analyzed in respective arms for category.||percent||Standard Deviation|Mean
669377|NCT01712061|Secondary|Change From Baseline in Serum Cystatin C at Weeks 12 and 16|Cystatin C is a protein which is mainly used as a biomarker of kidney function. If kidney function and GFR decline, the blood levels of cystatin C rise.|Baseline, Week 12, and Week 16|The FAS was defined as all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 post-dose efficacy measurement; n=number of participants analyzed in respective arms for category.||mg/dL||Standard Deviation|Mean
669378|NCT01712061|Secondary|Change From Baseline in Serum Creatinine at Weeks 1, 4, 8, 12 and 16|Serum creatinine is an indicator of kidney function. Creatinine is a substance formed from the metabolism of creatine, commonly found in blood, urine, and muscle tissue. It is removed from the blood by the kidneys and excreted in urine. Normal adult blood levels of creatinine=45 to 90 micromoles per liter (mcmol/L) for females, 60 to 110 mcmol/L for males, however normal values are age-dependent. Change from baseline=creatinine level at Week 1, 4, 8, 12 or 16 minus baseline level where higher scores represented decreased kidney function.|Baseline, Week 1, 4, 8, 12 and 16|The FAS was defined as all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 post-dose efficacy measurement; n=number of participants analyzed in respective arms for category.||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
669379|NCT01712061|Secondary|Change From Baseline in eGFR Using Cystatin Formula at Weeks 12 and 16|Serum cystatin C may be a more reliable endogenous marker of GFR than serum creatinine. eGFR was calculated using the Cystatin Formula and normalized to 1.73 m^2 body surface area.|Baseline, Week 12, and Week 16|The FAS was defined as all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 post-dose efficacy measurement; n=number of participants analyzed in respective arms for category.||mL/min/1.73m^2||Standard Deviation|Mean
669380|NCT01712061|Secondary|Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) Using the Abbreviated Modified Diet in Renal Disease (MDRD) Formula at Weeks 1, 4, 8, 12 and 16|eGFR was calculated using the MDRD equation and normalized to 1.73 m^2 body surface area. Age and corresponding creatinine at each visit (Weeks 1, 4, 8, 12 and 16) were used to calculate GFR|Baseline, Week 1, 4, 8, 12 and 16|The FAS was defined as all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 post-dose efficacy measurement; n=number of participants analyzed in respective arms for category.||mL/min/1.73m^2||Standard Deviation|Mean
669381|NCT01712061|Secondary|Change From Baseline in Urinary Protein to Creatinine Ratio (UPCR) at Weeks 4, 8, 12 and 16|The presence of protein in the urine (proteinuria) often implies kidney disease. Protein and creatinine concentrations were obtained from spot urine samples.|Baseline, Weeks 4, 8, 12 and 16|The FAS was defined as all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 post-dose efficacy measurement; n=number of participants analyzed in respective arms for category.||mg/mmolCr||Geometric Coefficient of Variation|Geometric Mean
669382|NCT01712061|Secondary|Change From Baseline in UACR at Weeks 4, 8 and 16|The presence of albumin in the urine (macroalbuminuria) is a marker of kidney disease. Albumin and creatinine concentrations were obtained from spot urine samples.|Baseline, Weeks 4, 8 and 16|The FAS was defined as all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 post-dose efficacy measurement; n=number of participants analyzed in respective arms for category.||mg/millimolar creatinine (mmolCr)||Geometric Coefficient of Variation|Geometric Mean
669383|NCT01712061|Primary|Percent Reduction From Baseline in Urinary Albumin to Creatinine Ratio (UACR) at Week 12|The presence of albumin in the urine (macroalbuminuria) is a marker of kidney disease. Albumin and creatinine concentrations were obtained from spot urine samples.|Baseline and Week 12|The Full Analysis Set (FAS) was defined as all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 post-dose efficacy measurement; n=number of participants analyzed in respective arms for category.||percent (%)||95% Confidence Interval|Mean
669384|NCT01712009|Secondary|Number of Participants With Adverse Events (AEs)|"Severity was graded using CTCAE version 3. A serious adverse event (SAE) is defined as an adverse event that meets at least 1 of the following serious criteria: • fatal; • life threatening; • requires in-patient hospitalization or prolongation of existing hospitalization; • results in persistent or significant disability/incapacity; • congenital anomaly/birth defect; • other medically important serious event.
The investigator assessed each adverse event for relatedness to investigational product(s) or other protocol-required therapies."|From first dose of investigational product (IP, naproxen or loratidine) or first dose of pegfilgrastim (Peg), whichever occurred first, until 30 days after last dose, up to 24 weeks.|Safety analysis set included all participants who received primary prophylaxis with pegfilgrastim according to the prophylactic medication actually received. Participants in the Naproxen or Loratadine groups who did not receive naproxen or loratadine are analyzed in the No Prophylaxis group for safety analyses.||participants|||Number
669385|NCT01712009|Secondary|Area Under the Curve (AUC) for Patient-reported Bone Pain|Patient-reported bone pain AUC was calculated using the trapezoidal rule with bone pain scores from day 1 to 5 for each cycle. The AUC across cycles is the average of AUCs across the cycle.|Five consecutive days during each cycle beginning on the day of pegfilgrastim administration (Day 2, 3, or 4 of each cycle)|"Full analysis set; all missing values of patient-reported bone pain within any cycle were imputed. n indicates the number of participants who entered each cycle."||units on a scale * days||Standard Error|Least Squares Mean
669386|NCT01712009|Secondary|Maximum Patient-reported Bone Pain by Cycle and Across Cycles|Participants completed a brief bone pain survey once per day for 5 days beginning the day they received their pegfilgrastim injection. The bone pain survey collected the severity of pain using a 0 (no pain) to 10 (worst pain) scale. Maximum patient-reported bone pain is the maximum of each participant’s bone pain values across survey Days 1-5 within each cycle. Across all cycles the maximum is the maximum of each patient-reported bone pain value across all survey days 1-5 and across all cycles. An ANOVA model with treatment as explanatory term was used.|Five consecutive days during each cycle beginning on the day of pegfilgrastim administration (Day 2, 3, or 4 of each cycle)|"Full analysis set; all missing values of patient-reported bone pain within any cycle were imputed. n indicates the number of participants who entered each cycle."||units on a scale||Standard Error|Least Squares Mean
669743|NCT01709500|Secondary|Percent Change From Baseline in Apo B at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on­ or off-treatment.|From Baseline to Week 52|Apo B ITT population.||percent change||Standard Error|Least Squares Mean
669387|NCT01712009|Secondary|Mean Patient-reported Bone Pain by Cycle and Across Cycles|Participants completed a brief bone pain survey once per day for 5 days beginning the day they received their pegfilgrastim injection. The bone pain survey collected the severity of pain using a 0 (no pain) to 10 (worst pain) scale. Mean patient-reported bone pain values are the average of each participant’s bone pain values across survey days 1-5 within each cycle. Across all cycles the mean is the average of each patient-reported bone pain value across all survey days 1-5 and across all cycles. An analysis of variance (ANOVA) model with treatment as explanatory term was used.|Five consecutive days during each cycle beginning on the day of pegfilgrastim administration (Day 2, 3, or 4 of each cycle)|"Full analysis set; all missing values of patient-reported bone pain within any cycle were imputed. n indicates the number of participants who entered each cycle."||units on a scale||Standard Error|Least Squares Mean
669388|NCT01712009|Secondary|Percentage of Participants With Severe Bone Pain by Cycle and Across Cycles|Bone pain data were captured as part of standard adverse event reporting. Severe bone pain is defined as grade 3 or 4 according to common terminology criteria for adverse events (CTCAE) version 3 grading criteria: Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, and Grade 4 = Life-threatening or disabling.|Cycles 1, 2, 3 and 4 (approximately 4 weeks each, depending on the chemotherapy dosing interval)|"Full analysis set; n indicates the number of participants who entered each cycle."||percentage of participants||95% Confidence Interval|Number
669389|NCT01712009|Secondary|Percentage of Participants With Bone Pain (All Grades) by Cycle (2-4) and Across Cycles|Bone pain data were captured as part of standard adverse event (AE) reporting.|Cycles 1, 2, 3 and 4 (approximately 4 weeks each, depending on the chemotherapy dosing interval)|"Full analysis set; n indicates the number of participants who entered each cycle."||percentage of participants||95% Confidence Interval|Number
669390|NCT01712009|Primary|Percentage of Participants With Bone Pain (All Grades) in Cycle 1|Bone pain data were captured as part of standard adverse event (AE) reporting.|Cycle 1 (approximately 4 weeks, depending on the chemotherapy dosing interval)|Full anlysis set||percentage of participants||95% Confidence Interval|Number
669391|NCT01711918|Secondary|Improvement of Premature Abdominal Fullness After Meals Based on Likert Scale|A subject will be considered a responder, if they report on a 6 point Likert scale that when compared to baseline, their symptoms are either 'somewhat better or markedly better'.|Baseline and End of study (2 years or last visit if patient withdraws)|||Participants|||Count of Participants
669392|NCT01711918|Secondary|Improvement of Abdominal Bloating or Distention Based on Likert Scale|A subject will be considered a responder, if they report on a 6 point Likert scale that when compared to baseline, their symptoms are either 'somewhat better or markedly better'.|Baseline and End of study (2 years or last visit if patient withdraws)|||Participants|||Count of Participants
669393|NCT01711918|Secondary|Improvement of Vomiting Based on Likert Scale|A subject will be considered a responder, if they report on a 6 point Likert scale that when compared to baseline, their symptoms are either 'somewhat better or markedly better'.|Baseline and End of study (2 years or last visit if patient withdraws)|||Participants|||Count of Participants
669394|NCT01711918|Secondary|Improvement of Nausea Based on Likert Scale|A subject will be considered a responder, if they report on a 6 point Likert scale that when compared to baseline, their symptoms are either 'somewhat better or markedly better'.|Baseline and End of study (2 years or last visit if patient withdraws)|||Participants|||Count of Participants
669395|NCT01711918|Primary|Improvement of Overall Symptoms Based on Likert Scale|A subject will be considered a responder, if they report on a 6 point Likert scale that when compared to baseline, their symptoms are either 'somewhat better or markedly better'.|Baseline and End of study (2 years or last visit if patient withdraws)|||Participants|||Count of Participants
669396|NCT01711866|Secondary|Patients Global Impressions of Change (PGIC) at the End of the Treatment Period or Early Withdrawal Visit|"The PGIC is a 7-point categorical rating scale in which the subject rates the changes in functioning over time as follows:
1 = Very much improved
2 = Much improved
3 = Minimally improved
4 = No change
5 = Minimally worse
6 = Much worse
7 = Very much worse."|Day 28 (Visit 5) of the 28 days Treatment Period or Early Withdrawal Visit|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF) as a method of imputation for missing observations. FAS includes all subjects with at least 1 patch application during Treatment Period, and with an evaluable UPDRS Part III total score at Baseline and at least 1 valid value after Baseline to Day 35.||participants|||Number
669397|NCT01711866|Primary|Clinical Global Impression (CGI) Item 4 (Side Effects) at the End of the Treatment Period or Early Withdrawal Visit|"The CGI Item 4 was used to assess side effects. It ranges from 0 to 4 as follows:
0 = Side effects not assessable
1 = No side effects
2 = Side effects do not significantly interfere with subject’s functioning
3 = Side effects significantly interfere with the subject’s functioning
4 = Side effects outweigh therapeutic efficacy."|Day 28 (Visit 5) of the 28 days Treatment Period or Early Withdrawal Visit|All 87 subjects of the Safety Set are included in the analysis of this outcome measure. Last Observation Carried Forward (LOCF) was used as a method of imputation for missing observations.||participants|||Number
669398|NCT01711853|Primary|AUCtau,ss|"Area under the plasma concentration-time curve of the total dabigatran at steady state over a uniform dosing interval tau was measured.
The samples for pharmacokinetics had to be taken from 30 min before drug administration up to 11 days after drug administration."|-0.5 hours (h), 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 23.5h, 47.5h, 71.5h, 95.5h, 119.5h, 155.5h, 167.5h, 168.5h, 169h, 170h, 171h, 172h, 174h, 176h, 179.5h, 180h, 192h, 216h, 240h|PKS||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
669399|NCT01711853|Primary|Cmax,ss|"Maximum concentration of Dabigatran etexilate in plasma at steady state was measured.
The samples for pharmacokinetics had to be taken from 30 min before drug administration up to 11 days after drug administration."|-0.5 hours (h), 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 23.5h, 47.5h, 71.5h, 95.5h, 119.5h, 155.5h, 167.5h, 168.5h, 169h, 170h, 171h, 172h, 174h, 176h, 179.5h, 180h, 192h, 216h, 240h|Pharmacokinetic set (PKS) which included all treated subjects that provided at least 1 observation for at least 1 primary pharmacokinetic endpoint without important protocol violations with respect to the evaluation of the pharmacokinetic endpoints and with predose values not greater than 5% of Cmax.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
669707|NCT01709513|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 12 -­ ITT Analysis|Combined Estimate for Adjusted Mean (Standard Error) at Week 24 from multiple imputation followed by robust regression including all available post-baseline data from Week 4 to Week 24 regardless of status on or off-treatment.|From Baseline to Week 12|Lipoprotein(a) ITT population.||percent change||Standard Error|Mean
669400|NCT01711736|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|A serious adverse event was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|During the entire study period (Day 0 – Day 180)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||subjects|||Number
669401|NCT01711736|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 28-day (Days 0-27) post-vaccination period.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||subjects|||Number
669402|NCT01711736|Secondary|Number of Subjects Reporting Any Potential Immune-Mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) were defined as a subset of adverse events that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which might or might not have an autoimmune aetiology. Any pIMD was defined as at least one pIMD experienced by the study subject.|During the entire study period (Day 0 to Day 180)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||subjects|||Number
669403|NCT01711736|Secondary|Number of Subjects Reporting Any Medically Attended Adverse Events (MAEs)|MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s).|During the entire study period (Day 0 to Day 180)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||subjects|||Number
669404|NCT01711736|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Fever|Any fever was defined as any fever ≥38.0 °C irrespective of intensity and relationship to vaccination. Related was defined as symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 fever was defined as fever ≥39.0 °C.|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||subjects|||Number
669405|NCT01711736|Secondary|Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains.|MGI was defined as the fold increase in serum haemagglutination inhibition (HI) GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2), Flu B/Hubei-Wujiagang/158/09 (Yamagata) and Flu B/Bri/60/08 (Victoria)|28 days after the last vaccine dose (at Day 28 for primed subjects and at Day 56 for unprimed subjects)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, in terms of antibody response measured by the Haemagglutination Inhibition assay, included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||Fold increase||95% Confidence Interval|Geometric Mean
669406|NCT01711736|Secondary|Number of Subjects Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains.|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2), Flu B/Hubei-Wujiagang/158/09 (Yamagata) and Flu B/Bri/60/08 (Victoria)|At Day 0 (for all subjects) and Day 28 after last vaccine dose (Day 28 for primed subjects and Day 56 for unprimed subjects)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, in terms of antibody response measured by the Haemagglutination Inhibition assay, included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||subjects|||Number
669407|NCT01711736|Secondary|Number of Seroconverted Subjects for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains of Fluarix Vaccine|A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2), Flu B/Hubei-Wujiagang/158/09 (Yamagata) and Flu B/Bri/60/08 (Victoria). This outcome concerns solely subjects in the Fluarix Group.|At Day 28 for primed subjects and at Day 56 for unprimed subjects|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, in terms of antibody response measured by the Haemagglutination Inhibition assay, included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||subjects|||Number
669408|NCT01711736|Secondary|Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Influenza Strains|HI antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2), Flu B/Hubei-Wujiagang/158/09 (Yamagata) and Flu B/Bri/60/08 (Victoria)|At Day 0 (for all subjects) and 28 days after the last vaccine dose (at Day 28 for primed subjects and at Day 56 for unprimed subjects)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, in terms of antibody response measured by the Haemagglutination Inhibition assay, included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||Titers||95% Confidence Interval|Geometric Mean
669520|NCT01710527|Secondary|Assessment of Subject Well-being Questionnaire|Subject well-being questionnaire was planned to be conducted at 1.0 and 5.0 hour post-dose. During vital sign recording each participants was planned to be asked about his well-being recorded during post study safety assessments. The data for this outcome measure was not collected during the study. Thus the results summary for this outcome measure was not produced.|Up to 38 days|Safety population.|||||
669409|NCT01711736|Primary|Number of Subjects Reporting Any, Grade 3 and Related Fever|Any fever was defined as any fever ≥38.0 degrees Celsius (°C) irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 fever was defined as fever ≥39.0 °C.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||subjects|||Number
669410|NCT01711736|Primary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms (Excluding Fever).|Solicited general symptoms assessed were drowsiness, irritability/fussiness and loss of appetite. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 irritability/fussiness was defined as crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite was defined as not eating at all. Grade 3 drowsiness was defined as drowsiness that prevented normal activity.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||subjects|||Number
669411|NCT01711736|Primary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain was defined as pain that prevented normal everyday activities. Grade 3 swelling was greater than 100 millimeters (mm) i.e. >100mm.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||subjects|||Number
669412|NCT01711736|Primary|Number of Seroconverted Subjects for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains of Quadrivalent Influenza GSK2282512A Vaccine.|A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2), Flu B/Hubei-Wujiagang/158/09 (Yamagata) and Flu B/Bri/60/08 (Victoria). This outcome concerns solely subjects in the GSK2282512A Group.|At Day 28 for primed subjects and at Day 56 for unprimed subjects|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, in terms of antibody response measured by the Haemagglutination Inhibition assay, included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||subjects|||Number
669413|NCT01711645|Secondary|Kinetics of the ELISA IgG Antibody Decline in Breast Milk Expressed in EU/ml.|Breast milk samples were collected from participants for evaluation of PT and FHA secretory IgA (sIgA) by ELISA. The protocol defined kinetics as assessment at each post-vaccination timepoint of the geometric mean fold rise, defined as the geometric mean of participants' fold rise in post vaccination sIgA relative to the pre-vaccination sIgA.|Prior to vaccination, 2 weeks, 6 weeks, and 6 months after vaccination|Only 4 participants were able to provide a breast milk (colostrum) sample at baseline and post vaccination samples had no detectable titer, resulting in a fold-rise analysis being uninterpretable; therefore, this analysis was not conducted.|||||
669414|NCT01711645|Secondary|Geometric Mean Fold Rise in Antibody Concentrations Assessed by ELISA in Breast Milk by Study Day|Breast milk samples were collected from participants for evaluation of secretory IgA (sIgA) by ELISA. Geometric mean fold rise was defined as the geometric mean of participants' fold rise in post vaccination sIgA relative to the pre-vaccination sIgA.|Prior to vaccination, 2 weeks, 6 weeks, and 6 months after vaccination|Only 4 participants were able to provide a breast milk (colostrum) sample at baseline and post vaccination samples had no detectable titer, resulting in a fold-rise analysis being uninterpretable; therefore, this analysis was not conducted.|||||
669415|NCT01711645|Secondary|Proportion of Participants With 4-fold Rise in Antibody in Breast Milk by Study Day.|Breast milk samples were collected from participants for evaluation of PT and FHA secretory IgA (sIgA) by ELISA. The lower limit of quantification (LLOQ) for the assay was 10 EU/mL. A 4-fold rise in concentration from prior to vaccination was defined as a post-vaccination sIgA concentration greater than or equal to 40 EU/mL for participants with baseline sIgA concentrations less than the LLOQ, or 4 times the baseline sIgA concentration for baseline sIgA concentrations greater than the LLOQ.|Prior to vaccination, 2 weeks, 6 weeks, and 6 months after vaccination|Only 4 participants were able to provide a breast milk (colostrum) sample at baseline and post vaccination samples had no detectable titer, resulting in a fold-rise analysis being uninterpretable; therefore, this analysis was not conducted.|||||
669416|NCT01711645|Secondary|ELISA GMC of Breast Milk IgA to PRN and FIM by Study Day.|Breast milk (colostrum) was collected from participants at baseline prior to vaccination for assessment of secretory IgA (sIgA) to the PRN and FIM antigen by ELISA. Available data at the timepoint were to be summarized by geometric mean of the concentration as reported in EU/mL along with the 95% confidence interval. The lower limit of quantitation (LLOQ) of the assay was 10 EU/mL.|Baseline (prior to vaccination), Week 2, Week 6 and Month 6 post vaccination|The laboratory staff was not successful in attempts to conduct the ELISA assay against the pertactin and fimbrae antigens with the breast milk samples.|||||
669417|NCT01711645|Secondary|ELISA GMC of Breast Milk IgA to FHA at Month 6.|Breast milk was collected from participants at 6 months post vaccination for assessment of secretory IgA (sIgA) to the FHA antigen by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL along with the 95% confidence interval.|6 months post vaccination|All participants providing a breast milk sample at the timepoint are included in the analysis population.||EU/mL||95% Confidence Interval|Geometric Mean
669418|NCT01711645|Secondary|ELISA GMC of Breast Milk IgA to FHA at Week 6.|Breast milk was collected from participants at 6 weeks post vaccination for assessment of secretory IgA (sIgA) to the FHA antigen by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL. Note that for the FHA at this timepoint, all participants had a concentration of 5, the imputed value for below the LLOQ of the assay (<10), and so the 95% CI is not reported, as there was no measurable variability in the data. The range is reported.|6 weeks post vaccination|All participants providing a breast milk sample at the timepoint are included in the analysis population.||EU/mL||Full Range|Geometric Mean
669419|NCT01711645|Secondary|ELISA GMC of Breast Milk IgA to FHA at Week 2.|Breast milk was collected from participants at 2 weeks post vaccination for assessment of secretory IgA (sIgA) to the FHA antigen by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL along with the 95% confidence interval.|2 weeks post vaccination|All participants providing a breast milk sample at the timepoint are included in the analysis population.||EU/mL||95% Confidence Interval|Geometric Mean
669420|NCT01711645|Secondary|ELISA GMC of Breast Milk IgA to FHA at Baseline.|Breast milk (colostrum) was collected from participants at baseline prior to vaccination for assessment of secretory IgA (sIgA) to the FHA antigen by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL along with the 95% confidence interval.|Baseline (prior to vaccination)|All participants providing a breast milk (colostrum) sample at the timepoint are included in the analysis population.||EU/mL||95% Confidence Interval|Geometric Mean
669421|NCT01711645|Secondary|ELISA GMC of Breast Milk IgA to PT at Month 6|Breast milk was collected from participants at 6 weeks after vaccination for assessment of secretory IgA (sIgA) to PT and FHA by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL. Note that for the PT at this timepoint, all participants had a value of 5, the imputed value for below the LLOQ of the assay (<10), and so the 95% CI is not reported, as there was no measurable variability in the data. The range is reported.|6 months post vaccination|All participants providing a breast milk sample at the timepoint are included in the analysis population.||EU/mL||Full Range|Geometric Mean
669422|NCT01711645|Secondary|ELISA GMC of Breast Milk IgA to PT at Week 6|Breast milk was collected from participants at 6 weeks after vaccination for assessment of secretory IgA (sIgA) to PT and FHA by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL. Note that for the PT at this timepoint, all participants had a value of 5, the imputed value for below the LLOQ of the assay (<10), and so the 95% CI is not reported, as there was no measurable variability in the data. The range is reported.|6 weeks post vaccination|All participants providing a breast milk sample at the timepoint are included in the analysis population.||EU/mL||Full Range|Geometric Mean
669423|NCT01711645|Secondary|ELISA GMC of Breast Milk IgA to PT at Week 2|Breast milk was collected from participants at 2 weeks after vaccination for assessment of secretory IgA (sIgA) to PT and FHA by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL. Note that for the PT at this timepoint, all participants had a value of 5, the imputed value for below the LLOQ of the assay (<10), and so the 95% CI is not reported, as there was no measurable variability in the data. The range is reported.|2 weeks post vaccination|All participants providing a breast milk sample at the timepoint are included in the analysis population.||EU/mL||Full Range|Geometric Mean
669424|NCT01711645|Secondary|ELISA GMC of Breast Milk IgA to Pertussis Toxin (PT) at Baseline.|Breast milk (colostrum) was collected from participants at baseline prior to vaccination for assessment of secretory IgA (sIgA) to the PT antigen by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL along with the 95% confidence interval. The lower limit of quantitation (LLOQ) of the assay was 10. Results of <10 were reported as half the LLOQ (5).|Baseline (prior to vaccination)|All participants providing a breast milk (colostrum) sample at the timepoint are included in the analysis population.||EU/mL||95% Confidence Interval|Geometric Mean
669425|NCT01711645|Primary|Kinetics of the ELISA IgG Antibody Rise in Serum|The assessment of the kinetics of the ELISA IgG antibody rise in serum was defined by the protocol as the geometric mean fold rise at each timepoint (reported separately above). No additional analysis was pre-defined or performed for this outcome measure.|Prior to and following Tdap, through 24 months post-vaccination|No analysis was conducted for this outcome measure. See previous outcome measures for geometric mean fold rises at each timepoint.|||||
669426|NCT01711645|Primary|Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 24|Blood samples were collected from participants for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens at baseline prior to vaccination and 24 months after vaccination. A 4-fold rise in antibody concentration from prior to vaccination was defined as a post-vaccination IgG greater than or equal to 40 EU/mL for participants with baseline IgG concentrations less than the LLOQ (10), or 4 times the baseline IgG concentration for baseline IgG concentrations greater than the LLOQ.|Prior to and 24 months after vaccination|All participants with blood collected and results reported at both timepoints are included in the analysis population.||Participants|||Count of Participants
669427|NCT01711645|Primary|Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 18|Blood samples were collected from participants for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens at baseline prior to vaccination and 18 months after vaccination. A 4-fold rise in antibody concentration from prior to vaccination was defined as a post-vaccination IgG greater than or equal to 40 EU/mL for participants with baseline IgG concentrations less than the LLOQ (10), or 4 times the baseline IgG concentration for baseline IgG concentrations greater than the LLOQ.|Prior to and 18 months after vaccination|All participants with blood collected and results reported at both timepoints are included in the analysis population.||Participants|||Count of Participants
669428|NCT01711645|Primary|Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 12|Blood samples were collected from participants for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens at baseline prior to vaccination and 12 months after vaccination. A 4-fold rise in antibody concentration from prior to vaccination was defined as a post-vaccination IgG greater than or equal to 40 EU/mL for participants with baseline IgG concentrations less than the LLOQ (10), or 4 times the baseline IgG concentration for baseline IgG concentrations greater than the LLOQ.|Prior to and 12 months after vaccination|All participants with blood collected and results reported at both timepoints are included in the analysis population.||Participants|||Count of Participants
669429|NCT01711645|Primary|Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 6|Blood samples were collected from participants for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens at baseline prior to vaccination and 6 months after vaccination. A 4-fold rise in antibody concentration from prior to vaccination was defined as a post-vaccination IgG greater than or equal to 40 EU/mL for participants with baseline IgG concentrations less than the LLOQ (10), or 4 times the baseline IgG concentration for baseline IgG concentrations greater than the LLOQ.|Prior to and 6 months after vaccination|All participants with blood collected and results reported at both timepoints are included in the analysis population.||Participants|||Count of Participants
669430|NCT01711645|Primary|Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Week 6|Blood samples were collected from participants for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens at baseline prior to vaccination and 6 weeks after vaccination. A 4-fold rise in antibody concentration from prior to vaccination was defined as a post-vaccination IgG greater than or equal to 40 EU/mL for participants with baseline IgG concentrations less than the LLOQ (10), or 4 times the baseline IgG concentration for baseline IgG concentrations greater than the LLOQ.|Prior to and 6 weeks after vaccination|All participants with blood collected and results reported at both timepoints are included in the analysis population.||Participants|||Count of Participants
669431|NCT01711645|Primary|Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Week 2|Blood samples were collected from participants for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens at baseline prior to vaccination and 2 weeks after vaccination. A 4-fold rise in antibody concentration from prior to vaccination was defined as a post-vaccination IgG greater than or equal to 40 EU/mL for participants with baseline IgG concentrations less than the LLOQ (10), or 4 times the baseline IgG concentration for baseline IgG concentrations greater than the LLOQ.|Prior to and 2 weeks after vaccination|All participants with blood collected and results reported at both timepoints are included in the analysis population.||Participants|||Count of Participants
669432|NCT01711645|Primary|ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 24|Blood was collected from participants at 24 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. A value of 5 EU/mL was imputed for results reported as below LLOQ. The geometric mean of participants’ concentrations at the timepoint was calculated, along with the 95% CI.|24 months post vaccination|All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.||EU/mL||95% Confidence Interval|Geometric Mean
669433|NCT01711645|Primary|ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 18|Blood was collected from participants at 18 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. A value of 5 EU/mL was imputed for results reported as below LLOQ. The geometric mean of participants’ concentrations at the timepoint was calculated, along with the 95% CI.|18 months post vaccination|All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.||EU/mL||95% Confidence Interval|Geometric Mean
669434|NCT01711645|Primary|ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 12|Blood was collected from participants at 12 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. A value of 5 EU/mL was imputed for results reported as below LLOQ. The geometric mean of participants’ concentrations at the timepoint was calculated, along with the 95% CI.|12 months post vaccination|All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.||EU/mL||95% Confidence Interval|Geometric Mean
669435|NCT01711645|Primary|ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 6|Blood was collected from participants at 6 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. A value of 5 EU/mL was imputed for results reported as below LLOQ. The geometric mean of participants’ concentrations at the timepoint was calculated, along with the 95% CI.|6 months post vaccination|All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.||EU/mL||95% Confidence Interval|Geometric Mean
669436|NCT01711645|Primary|ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Week 6|Blood was collected from participants at 6 weeks after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. A value of 5 EU/mL was imputed for results reported as below LLOQ. The geometric mean of participants’ concentrations at the timepoint was calculated, along with the 95% CI.|6 weeks post vaccination|All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.||EU/mL||95% Confidence Interval|Geometric Mean
669437|NCT01711645|Primary|ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Week 2|Blood was collected from participants at 2 weeks after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. A value of 5 EU/mL was imputed for results reported as below LLOQ. The geometric mean of participants’ concentrations at the timepoint was calculated, along with the 95% CI.|2 weeks post vaccination|All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.||EU/mL||95% Confidence Interval|Geometric Mean
669438|NCT01711645|Primary|ELISA Geometric Mean Concentrations (GMC) of Serum IgG to PT, FHA, PRN and FIM at Baseline|Blood was collected from participants at baseline prior to vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. Antibody concentrations were reported as ELISA units per milliliter (EU/mL). A value of 5 EU/mL was imputed for results reported as below the lower limit of quantitation (LLOQ) (<10 EU/mL). The geometric mean of participants’ concentrations at the timepoint was calculated, along with the 95% CI.|Baseline (prior to vaccination)|All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.||EU/mL||95% Confidence Interval|Geometric Mean
669439|NCT01711645|Primary|Geometric Mean Fold Rise in Serum IgG by ELISA at Month 24|Blood was collected from participants at baseline prior to vaccination and at 24 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. The geometric mean of participants' fold rise in antibody concentrations from baseline to post vaccination was calculated, along with the 95% CI.|Prior to and 24 months following vaccination|All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.||Fold Rise||95% Confidence Interval|Geometric Mean
669440|NCT01711645|Primary|Geometric Mean Fold Rise in Serum IgG by ELISA at Month 18|Blood was collected from participants at baseline prior to vaccination and at 18 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. The geometric mean of participants' fold rise in antibody concentrations from baseline to post vaccination was calculated, along with the 95% CI.|Prior to and 18 months following vaccination|All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.||Fold Rise||95% Confidence Interval|Geometric Mean
670086|NCT01704495|Secondary|Total Number of Days of Asthma-specific Hospital Admission/Intensive Care Unit Admissions||From start of treatment up to 6 months|Full analysis set||Days||90% Confidence Interval|Least Squares Mean
669441|NCT01711645|Primary|Geometric Mean Fold Rise in Serum IgG by ELISA at Month 12|Blood was collected from participants at baseline prior to vaccination and at 12 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. The geometric mean of participants' fold rise in antibody concentrations from baseline to post vaccination was calculated, along with the 95% CI.|Prior to and 12 months following vaccination|All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.||Fold Rise||95% Confidence Interval|Geometric Mean
669442|NCT01711645|Primary|Geometric Mean Fold Rise in Serum IgG by ELISA at Month 6|Blood was collected from participants at baseline prior to vaccination and at 6 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. The geometric mean of participants' fold rise in antibody concentrations from baseline to post vaccination was calculated, along with the 95% CI.|Prior to and 6 months following vaccination|All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.||Fold Rise||95% Confidence Interval|Geometric Mean
669443|NCT01711645|Primary|Geometric Mean Fold Rise in Serum IgG by ELISA at Week 6|Blood was collected from participants at baseline prior to vaccination and at 6 weeks after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. The geometric mean of participants' fold rise in antibody concentrations from baseline to post vaccination was calculated, along with the 95% CI.|Prior to and 6 weeks following vaccination|All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.||Fold Rise||95% Confidence Interval|Geometric Mean
669444|NCT01711645|Primary|Geometric Mean Fold Rise in Serum Immunoglobulin G (IgG) by ELISA at Week 2|Blood was collected from participants at baseline prior to vaccination and at 2 weeks after vaccination for assessment of IgG by ELISA against the pertussis toxin (PT), filamentous hemaggluttinin (FHA), pertactin (PRN) and fimbrae (FIM) antigens. Antibody concentrations were reported as ELISA units per milliliter (EU/mL). The geometric mean of participants' fold rise in antibody concentrations from baseline to post vaccination was calculated, along with the 95% confidence interval (CI).|Prior to and 2 weeks following vaccination|All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.||Fold Rise||95% Confidence Interval|Geometric Mean
669445|NCT01711424|Secondary|Schirmer Score|The Schirmer Test measures the rate of the secretion of tears produced by the eye over 5 minutes (min). The results indicate the presence of dry eye (Normal = greater than or equal to 10 millimeters (mm) of tears, Dry Eye = less than 10 mm of tears). The smaller the number, the more severe the dry eye.|Baseline, Week 4|All participants with complete data available for this outcome measure at Baseline and Week 4.||mm/5 min||Full Range|Median
669446|NCT01711424|Secondary|Tear Break Up Time (TBUT)|TBUT is the time in seconds required for dry spots to appear on the corneal surface after blinking. The longer it takes, the more stable the tear film.|Baseline, Week 4|All participants with complete data available for this outcome measure at Baseline and Week 4.||Seconds||Full Range|Median
669447|NCT01711424|Secondary|Number of Participants Where Physician Was Very Satisfied or Satisfied With OPTIVE PLUS®|The physician rated their satisfaction with OPTIVE PLUS® for the treatment of their patient's dry eye signs and symptoms using a 4-point scale (Very satisfied, Satisfied, Dissatisfied or Very dissatisfied).|Week 4|All participants with data available for this outcome measure.||Participants|||Number
669448|NCT01711424|Primary|Number of Participants Very Satisfied or Satisfied With OPTIVE PLUS®|Patients rated their satisfaction with OPTIVE PLUS® as treatment for dry eye signs and symptoms using a 4-point scale (Very satisfied, Satisfied, Dissatisfied or Very dissatisfied).|Week 4|All participants with data available for this outcome measure.||Participants|||Number
669449|NCT01711359|Secondary|Population PK: Area Under the Concentration Versus Time Curve at a Dosing Interval at Steady State (AUCtau,ss) of Baricitinib||Week 0: 15 and 60 minutes postdose; Week 4: 2 to 4 hours post-dose; Week 8: 4 to 6 hours post-dose; Week 12; Week 24; Week 32; Pre-dose|All randomized participants who received at least 1 dose of study drug (during study or rescue treatment) with evaluable PK data.||nanomole/Liter (nmol/L)||Geometric Coefficient of Variation|Geometric Mean
669450|NCT01711359|Secondary|Population Pharmacokinetics (PK): Peak Concentration at Steady State (Cmax,ss) of Baricitinib||Week 0: 15 and 60 minutes postdose; Week 4: 2 to 4 hours post-dose; Week 8: 4 to 6 hours post-dose; Week 12; Week 24; Week 32; Pre-dose|All randomized participants who received at least 1 dose of study drug (during study or rescue treatment) with evaluable PK data.||nanomole/Liter (nmol/L)||Geometric Coefficient of Variation|Geometric Mean
669451|NCT01711359|Secondary|Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Scores|The Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) questionnaire was developed to measure the effect of general health and symptom severity on work productivity and regular activities in the 7 days prior to the visit. It contains 6 items covering overall work productivity (health), overall work productivity (symptom), impairment of regular activities (health), and impairment of regular activities (symptom). Scores are calculated as impairment percentages. The WPAI-RA yields four types of scores: Absenteeism (work time missed), Presenteeism (impairment at work), Work productivity loss (overall work impairment), and Activity impairment.|Baseline, Week 24; Baseline Week 52|mITT population: all randomized participants who received at least 1 dose of study drug, with a baseline value and an observed value at the time point being summarized.||Percentage of Impairment||Standard Deviation|Mean
669452|NCT01711359|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-F) Scores|"The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale is a13-item, symptom-specific questionnaire that specifically assesses the participant's self-reported severity of fatigue and its impact upon daily activities and functioning. The FACIT-F uses a numeric rating scale of 0 (Not at all) to 4 (Very much) for each item to assess fatigue and its impact in the past 7 days. Total scores range from 0 to 52, with higher scores indicating less fatigue."|Baseline, Week 24; Baseline Week 52|mITT population: all randomized participants who received at least 1 dose of study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.||units on a scale||Standard Deviation|Mean
670062|NCT01704495|Secondary|Change From Baseline to Treatment Period (Day 57 to Day 84) for Asthma Control Days||Baseline (last 14 days before randomization) and Treatment Period (Days 57 to 84)|Full Analysis set||asthma control days||90% Confidence Interval|Least Squares Mean
669453|NCT01711359|Secondary|Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores (Self-Perceived Health)|A second component of the EQ-5D-5L is a self-perceived health score which is assessed using a VAS that ranges from 0 to 100 millimeter (mm), where 0 indicates the worst health you can imagine and 100 indicates the best health you can imagine.|Baseline, Week 24; Baseline Week 52|mITT population: all randomized participants who received at least 1 dose of study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.||millimeter||Standard Deviation|Mean
669454|NCT01711359|Secondary|Change From Baseline in European Quality of Life–5 Dimensions–5 Level (EQ-5D-5L) Scores|European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. One component consists of a descriptive system of the respondent's health comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1. A higher score indicates better health state.|Baseline, Week 24; Baseline Week 52|mITT population: all randomized participants who received at least 1 dose of study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.||units on a scale||Standard Deviation|Mean
669455|NCT01711359|Secondary|Change From Baseline in Mental Component Score (MCS) and Physical Component Score (PCS) of the Medical Outcomes Study 36-Item Short Form Health Survey Version 2 Acute (SF-36v2 Acute)|The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (MCS and PCS). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status or functioning.|Baseline, Week 24; Baseline Week 52|mITT population: all randomized participants who received at least 1 dose of study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.||units on a scale||Standard Deviation|Mean
669456|NCT01711359|Secondary|Change From Baseline in Worst Joint Pain Numeric Rating Scale (NRS)|"Participants rated their joint pain by selecting a number from 0 to 10 that best described their worst joint pain during the last 24 hours, where 0 represents no pain and 10 represents pain as bad as you can imagine."|Baseline, Week 24; Baseline Week 52|mITT population: all randomized participants who received at least 1 dose of study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.||units on a scale||Standard Deviation|Mean
669457|NCT01711359|Secondary|Change From Baseline in Worst Tiredness Numeric Rating Scale (NRS)|"Participants rated their tiredness by selecting a number from 0 to 10 that best described their worst tiredness during the last 24 hours, where 0 represents no tiredness and 10 represents as bad as you can imagine."|Baseline, Week 24; Baseline Week 52|mITT population: all randomized participants who received at least 1 dose of study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.||units on a scale||Standard Deviation|Mean
669458|NCT01711359|Secondary|Change From Baseline in Duration of Morning Joint Stiffness|Participants reported the duration of their morning joint stiffness (MJS) in hours and minutes. The participants were asked about their duration of morning joint stiffness on the day prior to the study visit to capture actual symptoms, since the participant may have had an atypical morning routine on the day of the study visit. If morning joint stiffness duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. A decrease in duration of morning joint stiffness indicated an improvement in the participant's condition.|Baseline, Week 52|mITT population: all randomized participants who received at least 1 dose of study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.||Minutes||95% Confidence Interval|Median
669459|NCT01711359|Secondary|Change From Baseline in Joint Space Narrowing and Bone Erosion Scores|X-rays of the hands/wrists and feet were assessed for joint space narrowing (JSN) and bone erosions. Assessment of JSN for each hand (15 joints per hand) and foot (6 joints per foot), including subluxation, is scored from 0 to 4, with 0 indicating no (normal) JSN and 4 indicating complete loss of joint space, bony ankylosis or luxation. JSN scores ranged from 0-168. A score of 0 would indicate no change and higher scores represent a worsening of joint space narrowing. The bone erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints of the feet. Each joint is scored according to the surface area involved from 0 to 5 for hand joints and 0 to 10 for the foot joints, with 0 indicating no erosion and the highest score (5 for the hand and 10 for the foot) indicating extensive loss of bone from more than one half of the articulating bone. Erosion scores ranged from 0 (no erosion) to 280 (high erosion).|Baseline, Week 24; Baseline, Week 52|mITT population: all randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-baseline assessment. Missing values due to discontinuation of study, rescue, or missing data were imputed using LE.||units on a scale||Standard Deviation|Mean
669460|NCT01711359|Secondary|Percentage of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Remission|"The ACR/EULAR definitions of RA remission include a Boolean-based definition. The Boolean-based definition of remission occurs when all 4 of the following criteria are met at the same visit: TJC28 ≤1, SJC28 ≤1, acute phase response using C-reactive protein (milligrams per deciliter) ≤1, Patient's Global Assessment of Disease Activity using VAS (cm) ≤1."|Week 12, Week 24, Week 52|mITT population: all randomized participants who received at least 1 dose of study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.||percentage of participants|||Number
670063|NCT01704495|Secondary|Change From Baseline to Treatment Period (Day 29 to Day 56) for Asthma Control Days||Baseline (last 14 days before randomization) and Treatment Period (Days 29 to 56)|Full Analysis set||asthma control days||90% Confidence Interval|Least Squares Mean
669461|NCT01711359|Secondary|Change From Baseline in Disease Activity Score 28–Erythrocyte Sedimentation Rate (DAS28-ESR)|DAS28 consisted of a composite score of the following variables: tender joint count (TJC28), swollen joint count (SJC28), erythrocyte sedimentation rate (ESR) (millimeters per hour), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using the following formula: DAS28-ESR=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.70*natural log(ESR)+0.014*Patient's Global VAS. Scores ranged 1.0-9.4, where lower scores indicated less disease activity.|Baseline, Week 24; Baseline, Week 52|mITT population: all randomized participants who received at least 1 dose of study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.||units on a scale||Standard Deviation|Mean
669462|NCT01711359|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) Score|The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition.|Baseline, Week 24; Baseline, Week 52|mITT population: all randomized participants who received at least 1 dose of study drug with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using modified last observation carried forward (mLOCF).||units on a scale||Standard Deviation|Mean
669463|NCT01711359|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response|"ACR70 Responder Index is composite of clinical, laboratory, and functional measures in RA. ACR70 Responder is a participant who has at least 70% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, HAQ-DI, pain due to arthritis, and hsCRP. Participants with missing responses and participants who discontinued study or drug or were rescued before analysis timepoint were deemed non-responders."|Week 12, Week 24, Week 52|mITT population: all randomized participants who received at least 1 dose of study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.||Percent of participants|||Number
669464|NCT01711359|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response|"ACR50 Responder Index is composite of clinical, laboratory, and functional measures in RA. ACR50 Responder is a participant who has at least 50% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, HAQ-DI, pain due to arthritis, and hsCRP. Participants with missing responses and participants who discontinued study or drug or were rescued before analysis time point were deemed non-responders."|Week 12, Week 24, Week 52|mITT population: all randomized participants who received at least 1 dose of study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.||Percent of participants|||Number
669465|NCT01711359|Secondary|Percentage of Participants Who Achieved a Simplified Disease Activity Index (SDAI) Score ≤3.3|SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Patient's Global Assessment of Disease Activity using VAS centimeters (cm), and Physician's Global Assessment of Disease Activity using VAS (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity. An index-based definition of remission occurs with an SDAI score ≤3.3.|Week 24|mITT population: all randomized participants who received at least 1 dose of study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.||percentage of participants|||Number
669466|NCT01711359|Secondary|Change From Baseline in the Modified Total Sharp Score (mTSS)|"X-rays of the hands/wrists and feet were scored for structural progression as measured using the mTSS (van der Heijde 2000). This methodology quantified the extent of bone erosions and joint space narrowing for 44 and 42 joints, with higher scores representing greater damage.
The mTSS at a time point is the sum of the erosion (range from 0 to 280) and JSN (range from 0 to 168) scores, for a maximum score of 448."|Baseline, Week 24|mITT population: all randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-baseline assessments. Missing values due to discontinuation of study, rescue, or missing data were imputed using linear extrapolation (LE).||units on a scale||Standard Deviation|Mean
669467|NCT01711359|Secondary|Change From Baseline in the Disease Activity Score Based on a 28-Joint Count and High-sensitivity C-reactive Protein (DAS28-hsCRP)|Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of a composite score of the following variables: tender joint count (TJC28), swollen joint count (SJC28), C-reactive protein (CRP) (milligrams per liter), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using the following formula: DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*Patient's Global VAS+0.96. Scores ranged 1.0-9.4, where lower scores indicated less disease activity.|Baseline, Week 24|mITT population: all randomized participants who received at least 1 dose of study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mBOCF.||units on a scale||Standard Deviation|Mean
669468|NCT01711359|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score|HAQ-DI assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area are averaged to calculate the HAQ-DI score, which ranges from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicates an improvement in the participant's condition.|Baseline, Week 24|mITT population: all randomized participants who received at least 1 dose of study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using modified baseline observation carried forward (mBOCF).||units on a scale||Standard Deviation|Mean
669469|NCT01711359|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% Improvement (ACR20)|"ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). ACR20 Responder is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity using visual analog scale (VAS), Health Assessment Questionnaire-Disability Index (HAQ-DI), pain due to arthritis, and high-sensitivity C-reactive protein (hsCRP). Participants with missing responses and participants who discontinued study or drug or were rescued before analysis time point were deemed non-responders."|Week 52|Modified Intent-to-Treat (mITT) population: all randomized participants who received at least 1 dose of study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using nonresponder imputation (NRI).||Percent of participants|||Number
669470|NCT01711359|Primary|Percentage of Participants Achieving American College of Rheumatology 20% Improvement (ACR20)|"ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). ACR20 Responder is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity using visual analog scale (VAS), Health Assessment Questionnaire-Disability Index (HAQ-DI), pain due to arthritis, and high-sensitivity C-reactive protein (hsCRP). Participants with missing responses and participants who discontinued study or drug or were rescued before analysis time point were deemed non-responders."|Week 24|Modified Intent-to-Treat (mITT) population: all randomized participants who received at least 1 dose of study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using nonresponder imputation (NRI).||Percent of participants|||Number
669471|NCT01711216|Secondary|Time to Relapse|The intention was to measure time to relapse, but since a regular cycle was maintained longer than the period of follow up observation, no resulting variable counted in time was received. Instead, what was measured was the percentage of participants who maintained a regular cycle. Measured only for patients who had achieved cycle regularization at the end of treatment period.|Up to 6 months or longer after ended treatment|"Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Data for 55 patients was missing.
Among the patients who achieved cycle regularization (Follow-up Analysis Set), a majority (>85%) maintained regular cycles for the whole follow-up period"||percentage of subjects|||Number
669472|NCT01711216|Primary|Number of Patients With Regular Menstrual Cycles During Follow-up (by Number of Cycles)||up to 6 months|Follow-up analysis set 915 patients. Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Data for 55 patients was missing. Therefore, 860 patients were analyzed.||participants|||Number
669473|NCT01711216|Primary|Number of Patients Received Dydrogesterone Therapy Cycles (by Cycle Number)||up to 6 months|Follow-up analysis set 915 patients. Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Data for 55 patients was missing. Therefore, 860 patients were analyzed.||participants|||Number
669474|NCT01711216|Secondary|Change of Intensity of Anxiety|Will be measured only for patients who had achieved cycle regularization at the end of treatment period. Intensity of anxiety will be measured using 11-point scale where 0 means no anxiety and 10 means maximum anxiety|From 1 month to 12 months|Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Data for 55 patients was missing.||units on a scale||Standard Deviation|Mean
669475|NCT01711216|Secondary|Change of Pain Intensity During Menstruation|Measured only for patients who had achieved cycle regularization at the end of treatment period. Pain intensity will be measured using 11-point Likert scale where 0 means no pain and 10 means worst pain|From 1 month to 12 months|Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Data for 55 patients was missing.||units on a scale||Standard Deviation|Mean
669476|NCT01711216|Secondary|Change of Duration of Menstrual Bleeding in Days in Group of Patients With Oligomenorrhea|Measured only for patients who had achieved cycle regularization at the end of treatment period. Oligomenorrhea is defined as cycle duration > 35 days|From 1 month to 12 months|Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Patients with oligomenorrhea in subset of FAS.||days||Standard Deviation|Mean
669477|NCT01711216|Secondary|Change of Duration of Menstrual Bleeding in Days in Group of Patients With Polymenorrhea|Measured only for patients who had achieved cycle regularization at the end of treatment period. Polymenorrhea is defined as cycle duration < 21 days|From 1 month to 12 months|Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Patients with polymenorrhea in subset of FAS.||days||Standard Deviation|Mean
669478|NCT01711216|Secondary|Proportion of Patients With 6 Consecutive Regular Cycles Out of Total Number of Patients Who Had Achieved Cycle Regularization at the End of Treatment Period|Measured only for patients who had achieved cycle regularization at the end of treatment period. Regular cycle is defined as cycle duration 21-35 days, inclusive|Up to 12 months|Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Data for 55 patients was missing.||percentage of subjects|||Number
669479|NCT01711216|Secondary|Proportion of Patients With 3 Consecutive Regular Cycles Out of Total Number of Patients Who Had Achieved Cycle Regularization at the End of Treatment Period|Measured only for patients who had achieved cycle regularization at the end of treatment period. Regular cycle is defined as cycle duration 21-35 days, inclusive|Up to 9 months|Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Data for 55 patients was missing.||percentage of subjects|||Number
669480|NCT01711216|Secondary|Overall Clinical Response on Treatment Assessed by Physician|Overall clinical response assessed by physician will be determined based on a four-point-scale, where 4 = excellent, 3 = good, 2 = fair, and 1 = poor response.|Up to 6 months|Full Analysis Set (FAS): 955 patients. All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles. Data for 36 patients were missing. Therefore, 919 patients were analyzed.||participants|||Number
669481|NCT01711216|Secondary|Patient Satisfaction With the Treatment|Patient satisfaction will be determined based on a 5-point Clinical Global Impression of Severity scale, where 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat satisfied, 4 = satisfied, 5 = very satisfied.|Up to 6 months|Full Analysis Set (FAS): 955 patients. All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles. Data for 36 patients were missing. Therefore, 919 patients were analyzed.||participants|||Number
669482|NCT01711216|Secondary|Change of Intensity of Anxiety From Baseline to the End of Treatment|Intensity of anxiety will be measured using 11-point scale where 0 means no anxiety and 10 means maximum anxiety|From 1 month to 6 months|Full Analysis Set (FAS): All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles. Data for 51 patients missing.||units on a scale||Standard Deviation|Mean
669483|NCT01711216|Secondary|Change of Pain Intensity During Menstruation From Baseline to End of Treatment|Pain intensity will be measured using 11-point Likert scale where 0 means no pain and 10 means worst pain|From 1 month to 6 months|Full Analysis Set (FAS): All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles. Data from 39 patients missing||units on a scale||Standard Deviation|Mean
669484|NCT01711216|Secondary|Change of Duration of Menstrual Bleeding in Group of Patients With Oligomenorrhea|Oligomenorrhea is defined as cycle duration > 35 days and the duration of menstrual bleeding was evaluated from baseline to end of treatment in days|From 1 month to 6 months|Full Analysis Set (FAS): All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles. Patients with oligomenorrhoea in FAS||days||Standard Deviation|Mean
669485|NCT01711216|Secondary|Change of Duration of Menstrual Bleeding in Group of Patients With Polymenorrhea|Polymenorrhea is defined as cycle duration < 21 days and the duration of menstrual bleeding was evaluated from baseline to end of treatment in days|From 1 month to 6 months|Full Analysis Set (FAS): All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles. Patients with polymenorrhoea in FAS||days||Standard Deviation|Mean
669486|NCT01711216|Secondary|Change of Cycle Duration From Baseline to End of Treatment in Days in Group of Patients With Oligomenorrhea|Oligomenorrhea is defined as cycle duration > 35 days and the change in duration of the menstrual cycle during treatment was evaluated|From 1 month to 6 months|Full Analysis Set (FAS): All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles. Patients with oligomenorrhoea in FAS||days||Standard Deviation|Mean
669487|NCT01711216|Secondary|Change of Cycle Duration From Baseline to End of Treatment in Days in Group of Patients With Polymenorrhea|Polymenorrhea was defined as cycle duration < 21 days and the change in duration of the menstrual cycle during treatment was evaluated|From 1 month to 6 months|Full Analysis Set (FAS): All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles. Patients with polymenorrhoea in FAS||days||Standard Deviation|Mean
669488|NCT01711216|Secondary|Proportion of Patients Reporting at Least One Regular Cycle Over the Treatment Period|Regular cycle is defined as cycle duration between 21 to 35 days, inclusive. Treatment period in this observational program can be from 1 cycle to 6 consecutive cycles. This program does not include patients who required dydrogesterone therapy, according to physician's decision, more than 6 consecutive cycles|Up to 6 months|Full Analysis Set (FAS): All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles||percentage of subjects|||Number
669489|NCT01711177|Primary|Blood Oxygenation|For each subject, all the measurements will be done during an 1 hour appointment.|1 hour|||percentage of oxygenation||95% Confidence Interval|Mean
669490|NCT01710839|Secondary|Visual Field|Goldman Visual Field changes at 6 and 12 months from baseline. Goldmann perimetry is a method used to map a patient's field of vision (central and peripheral). Changes will be assessed by manual digital quantification of GVF plots.|6 and 12 Months|Patients who completed GVF testing at baseline, M6, and M12 with adequate fixation and cooperation during testing were included in GVF analyses (n=14)||square degrees||Standard Error|Mean
669491|NCT01710839|Secondary|Aqueous VEGF Levels|VEGF, other cytokines and ranibizumab levels in aqueous and serum samples at randomization and at the exit or early termination visit.|12 Months|Analysis of this outcome measure is still in progress. Data will be reported when the analysis is completed.|||||
669492|NCT01710839|Secondary|Central Foveal Outcome|Mean change in Central Foveal Volume on High Resolution OCT.|12 months|1 patient withdrew from the study before month 12||cubic millimeters||Standard Deviation|Mean
669493|NCT01710839|Secondary|Neovascularization of the Iris, Optic Nerve and Elsewhere|Percent of patients that develop neovascularization of the iris, optic nerve and/or elsewhere.|12 months|||percentage of patients|||Number
669494|NCT01710839|Secondary|Adverse Events|Incidence and severity of adverse events (ocular and non-ocular).|12 months|||Participants|||Count of Participants
669495|NCT01710839|Secondary|Foveal Avascular Zone|Assess change in foveal avascular zone area and largest diameter, measured during the early phase of the angiogram|12 months|Analysis of this outcome measure is still in progress. Data will be reported when the analysis is completed.|||||
669496|NCT01710839|Secondary|Retinal Ischemia|Quantify change in area of perfused and ischemic retina.|12 month period|Analysis of this outcome measure is still in progress. Data will be reported when the analysis is completed.|||||
669497|NCT01710839|Primary|Visual Acuity|Evaluate the mean change from baseline in ETDRS best-corrected visual acuity at 12 months. The ETDRS protocol is a widely accepted international standard for macular laser photocoagulation treatment. A higher score represents better functioning.|12 month period|1 patient withdrew from the study before month 12||ETDRS BCVA Letters||Standard Error|Mean
669498|NCT01710839|Primary|Total Number of Intravitreal Injections Over a 12 Month Period|Assess the number of intravitreal injections over 12 months.|12 months|||injections||Full Range|Mean
669499|NCT01710800|Primary|Number of Impedance Episodes Following PPI and Placebo|Impedance is defined as a 50% decrease from baseline in retrograde movement of liquid from the stomach to the esophagus. In other words, it measures the number of retrograde reflux episodes.|1 week|We analyzed as per protocol. Only patients who completed both 24 hour pH studies with impedance were analyzed.||number of episodes||Standard Deviation|Mean
669521|NCT01710527|Secondary|Number of Participants With Abnormal Periodic Physical Examination Results|Brief physical examination was performed at each check-in, check-out and complete physical examination during screening and at the end of the clinical part of the study.|Up to 38 days|Safety population.||Participants|||Number
669500|NCT01710787|Secondary|Intraoral Soft-tissue Anesthesia (Onset and Duration)|Mean onset and duration of incisive papilla anesthesia based on number of patients who reported no pain when soft-tissue was tested with a probe at designated timepoints|up to 120 mins post-dose|The analysis population includes patients who received a rescue injection of local anesthetic. Local anesthetic may cause soft-tissue anesthesia, impacting this endpoint. In addition, only patients from one site (out of the two sites for the study) are used for this analysis. The other site administered this assessment incorrectly.||minutes||Standard Deviation|Mean
669501|NCT01710787|Secondary|Alcohol Sniff Test|The distance from the nose (in centimeters) that a patient is able to detect the smell of alcohol on an alcohol swab.|administered at baseline, 120 minutes and approximately 24 hours after drug administration|||cm||Standard Deviation|Mean
669502|NCT01710787|Secondary|The Profile Over Time of Diastolic Blood Pressure||from baseline to 120 minutes following drug administration|||mmHg||Standard Deviation|Mean
669503|NCT01710787|Secondary|The Profile Over Time of Systolic Blood Pressure||from baseline to 120 minutes following drug administration|||mmHg||Standard Deviation|Mean
669504|NCT01710787|Secondary|The Profile Over Time of Heart Rate||from baseline to 120 minutes following drug administration|||beats per minute||Standard Deviation|Mean
669505|NCT01710787|Secondary|Absolute Maximum Change From Baseline in Diastolic Blood Pressure||from baseline to 120 minutes following drug administration|||mmHg||Standard Deviation|Mean
669506|NCT01710787|Secondary|Absolute Maximum Change From Baseline in Systolic Blood Pressure||from baseline to 120 minutes following drug administration|||mm Hg||Standard Deviation|Mean
669507|NCT01710787|Secondary|Absolute Maximum Change From Baseline in Heart Rate||from baseline to 120 minutes following drug administration|||bpm||Standard Deviation|Mean
669508|NCT01710787|Secondary|Number of Participants With a Decrease From Baseline in Diastolic Blood Pressure Greater Than or Equal to 10 mm Hg and to a Value Lower Than 50 mm Hg||at any time within 120 minutes following drug administration|||participants|||Number
669509|NCT01710787|Secondary|Number of Participants With an Increase From Baseline in Diastolic Blood Pressure Greater Than or Equal to 15 mm Hg and to a Value Higher Than 105 mm Hg||at any time within 120 minutes following drug administration|||Participants|||Count of Participants
669510|NCT01710787|Secondary|Number of Participants With a Decrease From Baseline in Systolic Blood Pressure Greater Than or Equal to 15 mm Hg and to a Value Lower Than 90 mm Hg||at any time within 120 minutes following drug administration|||Participants|||Count of Participants
669511|NCT01710787|Secondary|Number of Participants With an Increase From Baseline in Systolic Blood Pressure Greater Than or Equal to 25 mm Hg and to a Value Higher Than 160 mm Hg||at any time within 120 minutes following drug administration|||Participants|||Count of Participants
669512|NCT01710787|Secondary|Number of Participants With a Heart Rate Lower Than 50 Bpm||at any time within 120 minutes following drug administration|||Participants|||Count of Participants
669513|NCT01710787|Secondary|Number of Participants With a Heart Rate Higher Than 125 Bpm||at any time within 120 minutes following drug administration|||Participants|||Count of Participants
669514|NCT01710787|Secondary|Intraoral Soft-tissue Anesthesia (Yes/no)|Number of patients who reported no pain when incisive papilla soft-tissue was tested with a probe at designated timepoints|at Baseline, 15, 30, 45, 60, 90, and 120 minutes with a 3 minute window|Only patients from one site (out of the two sites for the study) are used for this analysis. The other site administered this assessment incorrectly.||Participants|||Count of Participants
669515|NCT01710787|Primary|Number of Participants Who Completed the Study Dental Procedure After Without Need for Rescue by Injection of Local Anesthetic.|If the participant does not have sufficient anesthesia to complete the Study Dental Procedure, the participant is given a rescue injection of local anesthetic and is considered a failure for this outcome.|at 15 minutes with a 3 minute window|||percentage of patients||95% Confidence Interval|Number
669516|NCT01710657|Secondary|Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Treatment Period (i.e., Titration + Maintenance Period)|"Partial-onset seizure (POS) frequency per 28 days was calculated as:
POS frequency = (Number of POS over the specified time interval) / (Number of days in the interval with available diary data) x 28.
A negative value in Change in Partial-onset seizure frequency indicates a reduction of Partial-onset seizure frequency from Baseline to the Treatment Period."|8-week Baseline Period (Visit 1 to 3) to the 16-week Treatment Period (Visit 3 to 8)|The Full Analysis Set consists of all subjects who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline efficacy assessment.||Seizures per 28 days||Full Range|Median
669517|NCT01710657|Secondary|Percent Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Maintenance Period|Calculates as 28-day seizure frequency during the Maintenance Period - 28-day seizure frequency during the Baseline Period, divided by the 28-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in Partial-Onset Seizure frequency from Baseline to the Maintenance Period.|8-week Baseline Period (Visit 1 to 3) to the 12-week Maintenance Period (Visit 5 to 8)|The Full Analysis Set consists of all subjects who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline efficacy assessment.||percentage change||Full Range|Median
669518|NCT01710657|Secondary|The Proportion of Individual Patients Who Experience a 50 % or Greater Reduction in Seizure Frequency From Baseline to the Maintenance Period (50 % Responder Rate)||8-week Baseline Period (Visit 1 to 3) to the 12-week Maintenance Period (Visit 5 to 8)|The Full Analysis Set consists of all subjects who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline efficacy assessment.||participants|||Number
669519|NCT01710657|Primary|Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Maintenance Period|"Partial-onset seizure (POS) frequency per 28 days was calculated as:
POS frequency = (Number of POS over the specified time interval) / (Number of days in the interval with available diary data) x 28.
A negative value in Change in Partial-onset seizure frequency indicates a reduction of Partial-onset seizure frequency from Baseline to the Maintenance Period."|8-week Baseline Period (Visit 1 to 3) and 12-week Maintenance Period (Visit 5 to 8)|The Full Analysis Set consists of all subjects who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline efficacy assessment.||Seizures per 28 days||Full Range|Median
670087|NCT01704495|Secondary|Rate of Asthma-specific Hospital Admission/Intensive Care Unit Admissions During 6 Months||From start of treatment up to 6 months|||Exacerbations per 6 month||90% Confidence Interval|Least Squares Mean
669522|NCT01710527|Secondary|Number of Participants With Abnormal Vital Sign Results|Vital signs measurements (blood pressure, respiratory rate, pulse rate and oral temperature) were conducted during screening and during post study safety assessments. Vital signs measurement were also performed at each check-in and at checkout and were also recorded before dosing of study drug, between 2-3, 9–10 and 36.0 hour post-dose. Measurements were recorded in sitting position after rest of at least 5 min.|Up to 38 days|Safety population.||Participants|||Number
669523|NCT01710527|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, associated with liver injury and impaired liver function defined as alanine aminotransferase >=3 x upper limit of normal (ULN), and total bilirubin >=2 x ULN or international normalized ratio >1.5.|Up to 38 days|Safety population was defined as participants who received at least one dose of the study drug.||Participants|||Number
669524|NCT01710527|Primary|Apparent First-order Elimination or Terminal Rate Constant|Plasma samples for PK analysis were drawn at indicated time points of each treatment period. The apparent first-order elimination or terminal rate constant was calculated from a semi logarithmic plot of the plasma concentration versus time. The parameter was calculated by linear least-square regression analysis using the last three (or more) non-zero plasma concentrations.|Pre- dose (0.0 hour), post-dose at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0 and 36.0 hour in each period.|PK population. Data is presented for the participants available at the time of assessment.||1/hour||Standard Deviation|Mean
669525|NCT01710527|Primary|Percentage of Area Under Curve Extrapolated to Arrive at AUC0-infinity (AUC%_Extrapolated)|Plasma samples for PK analysis were drawn at indicated time points of each treatment period. AUC%_Extrapolated was obtained by subtracting AUC0-t from AUC0-infinity divided by AUC0-infinity and multiplied by 100.|Pre- dose (0.0 hour), post-dose at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0 and 36.0 hour in each period.|PK population. Data is presented for the participants available at the time of assessment.||Percentage of area||Standard Deviation|Mean
669526|NCT01710527|Primary|Terminal Half-life (T-half) Over Period|Plasma samples for PK analysis were drawn at indicated time points of each treatment period. The elimination or terminal half-life was calculated by dividing 0.693 (natural logarithm of 2) with elimination rate constant obtained as semi logarithmic plot of the plasma concentration versus time.|Pre- dose (0.0 hour), post-dose at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0 and 36.0 hour in each period.|PK population. Data is presented for the participants available at the time of assessment.||hour||Standard Deviation|Mean
669527|NCT01710527|Primary|Time of the Maximum Plasma Concentration (T-max) Over Period|Plasma samples for PK analysis were drawn at indicated time points of each treatment period. If the maximum value occurs at more than one point T-max was defined as the first time point with this value.|Pre- dose (0.0 hour), post-dose at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0 and 36.0 hour in each period.|PK population. Data is presented for the participants available at the time of assessment.||hour||Standard Deviation|Median
669528|NCT01710527|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUC0-t) and Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-infinity)|"Plasma samples for PK analysis were drawn at indicated time points of each treatment period.
AUC0-t was calculated by the linear trapezoidal rule from measured data points from time of administration until the time of last quantifiable concentration. AUC0- infinity was estimated by linear trapezoidal rule and was sum of the AUC0-t and extrapolated to infinity by dividing the estimated last measurable plasma concentration by elimination rate constant. The AUC0- infinity was the sum of the estimated and extrapolated parts."|Pre- dose (0.0 hour), post-dose at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0 and 36.0 hour in each period.|PK population. Data is presented for the participants available at the time of assessment.||ng*hour/mL||Standard Deviation|Mean
669529|NCT01710527|Primary|Mean Maximal Measured Plasma Concentration (Cmax) After a Single Dose|Plasma samples for pharmacokinetic (PK) analysis were drawn at indicated time points of each treatment period. Cmax was defined as maximal measured plasma concentration over the time span specified.|Pre- dose (0.0 hour), post-dose at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0 and 36.0 hour in each period.|PK population was defined as all participants who had a PK measurement available. Data is presented for the participants available at the time of assessment.||Nanogram per milliltre (ng/mL)||Standard Deviation|Mean
669530|NCT01710514|Secondary|Blood Progesterone Concentration||Weeks 2, 4, 5, 8, and end of study|FAS population||ng/mL||Standard Deviation|Mean
669531|NCT01710514|Secondary|Clinical Pregnancy Rate|Defined as presence of a gestational sac on transvaginal ultrasound|Week 4 of study|FAS with ET population||percentage of participants||95% Confidence Interval|Number
669532|NCT01710514|Secondary|Rate of Positive βeta Human Chorionic Gonadotrophin (βhCG)||Week 2 of study|FAS with ET population In the TID group 13 subjects had a positive beta-hCG assessment while 14 subjects had a positive clinical pregnancy at Week 4. This is because one subject had a negative beta-hCG at Week 2, but she had a positive local serum hCG on the same day and continued the trial. Then clinical and ongoing pregnancy were confirmed.||percentage of participants||95% Confidence Interval|Number
669533|NCT01710514|Primary|Ongoing Pregnancy Rate|Defined as identification of fetal survival and fetal heart movements on transvaginal ultrasound|Week 5 of study|FAS with ET population||percentage of participants||95% Confidence Interval|Number
669534|NCT01710514|Primary|The Proportion of Subjects With Blood Progesterone Concentration Not Less Than 10 ng/ml||Day 5 of treatment|FAS population||percentage of subjects||95% Confidence Interval|Number
669535|NCT01710501|Secondary|Number of Participants Developing Post-baseline Antiviral Resistance to Grazoprevir Among Participants Not Achieving SVR24 Response|Post-baseline resistance associated variants (RAV) analysis was conducted by comparing the amino acid sequences at virologic failure time points to those at baseline (BL): Day 1, pre-dose. A post-BL variant was defined as an amino acid substitution within HCV NS3/4A that was present after the first dose at virologic failure and follow-up visits but not at BL. Post-BL variant analysis was conducted for participants who did not achieve SVR24 who had sequence data available.|From Day 1 up to Follow-up Week 24 (up to 48 weeks total)|Treated non-SVR24 participants with BL and post-BL samples sequenced for RAVs.||participants|||Number
669536|NCT01710501|Secondary|Percentage of Subjects Achieving SVR24|HCV RNA was measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay, which has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. SVR24 was defined as HCV RNA <25 IU/mL (either target detected, unquantifiable or target not detected) 24 weeks after the end of all study therapy.|24 weeks after end of treatment (up to 48 weeks total)|Participants in the PP Population (all randomized participants receiving ≥1 dose of study treatment and no important protocol deviation) with available data.||percentage of participants||95% Confidence Interval|Number
669537|NCT01710501|Secondary|Percentage of Participants Achieving SVR4|HCV RNA was measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay, which has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. SVR4 was defined as HCV RNA <25 IU/mL (either target detected, unquantifiable or target not detected) 4 weeks after the end of all study therapy.|4 weeks after end of treatment (up to 28 weeks total)|Participants in the PP Population (all randomized participants receiving ≥1 dose of study treatment and no important protocol deviation) with available data.||percentage of participants||95% Confidence Interval|Number
669538|NCT01710501|Secondary|Percentage of Participants Achieving HCV RNA <25 IU/mL During Treatment by Time Point|HCV RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay on blood samples drawn from each participant at Week 2, Week 4, Week 12, and at end of treatment. The assay has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL.|From TW 2 through end of treatment (up to 24 weeks)|Participants in the PP Population (all randomized participants receiving ≥1 dose of study treatment and no important protocol deviation) with available data.||percentage of participants||95% Confidence Interval|Number
669539|NCT01710501|Secondary|Percentage of Participants Achieving Undetectable HCV RNA During Treatment by Time Point|HCV RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay on blood samples drawn from each participant at Week 2, Week 4, Week 12, and at end of treatment. The assay has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. Undetectable HCV RNA was defined as HCV RNA < 9.3 IU/mL.|From Treatment Week (TW) 2 through end of treatment (up to 24 weeks)|Participants in the PP Population (all randomized participants receiving ≥1 dose of study treatment and no important protocol deviation) with available data.||percentage of participants||95% Confidence Interval|Number
669540|NCT01710501|Primary|Number of Participants Discontinued From Study Treatment Due to AEs During the Treatment Period and First 14 Follow-up Days|An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol -specified procedure, whether or not considered related to the medicinal product or protocol -specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an adverse event.|Up to 24 weeks|APaT Population; all randomized participants who received at least one dose of study treatment.||participants|||Number
669541|NCT01710501|Primary|Number of Participants Experiencing at Least One Adverse Event (AE) During the Treatment Period and First 14 Follow-up Days|An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol -specified procedure, whether or not considered related to the medicinal product or protocol -specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an adverse event.|14 days following last dose of study drug (up to 26 weeks)|All Participants as Treated (APaT) Population; all randomized participants who received at least one dose of study treatment.||participants|||Number
669542|NCT01710501|Primary|Percentage of Participants Achieving Sustained Virologic Response at 12 Weeks After the End of Treatment (SVR12)|Hepatitis C virus ribonucleic acid (HCV RNA) was measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay, which has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. SVR12 was defined as HCV RNA <25 IU/mL (either target detected, unquantifiable or target not detected) 12 weeks after the end of all study therapy.|12 weeks after end of treatment (up to 36 weeks total)|Participants in the Per-Protocol (PP) Population (all randomized participants receiving ≥1 dose of study treatment and no important protocol deviation) with available data.||percentage of participants||95% Confidence Interval|Number
669543|NCT01710358|Secondary|Population PK: Area Under the Concentration Versus Time Curve at a Dosing Interval at Steady State (AUCtau,ss) of Baricitinib||Week 0: 15 and 60 minutes postdose; Week 4: 2 to 4 hours post-dose; Week 8: 4 to 6 hours post-dose; Week 12; Week 12; Week 24; Week 32: Pre-dose|All randomized participants who received at least 1 dose of study drug (during study or rescue treatment) with evaluable PK data.||nanomole*hr/Liter (nmol*hr/L)||Geometric Coefficient of Variation|Geometric Mean
669544|NCT01710358|Secondary|Population Pharmacokinetics (PK): Peak Concentration at Steady State (Cmax,ss) of Baricitinib||Week 0: 15 and 60 minutes postdose; Week 4: 2 to 4 hours post-dose; Week 8: 4 to 6 hours post-dose; Week 12; Week 12; Week 24; Week 32: Pre-dose|All randomized participants who received at least 1 dose of study drug (during study or rescue treatment) with evaluable PK data.||nanomole/Liter (nmol/L)||Geometric Coefficient of Variation|Geometric Mean
679157|NCT01587079|Secondary|Peak Change From Baseline in FEV1 on Treatment Day 1|Peak change from Baseline in FEV1 on Treatment|Day 1|MITT||Milliliters||95% Confidence Interval|Least Squares Mean
669545|NCT01710358|Secondary|Change From Baseline in Joint Space Narrowing (JSN) and Bone Erosion Scores|"X-rays of the hands/wrists and feet were assessed for joint space narrowing (JSN) and bone erosions. Assessment of JSN for each hand (15 joints per hand) and foot (6 joints per foot), including subluxation, is scored from 0 to 4, with 0 indicating no (normal) JSN and 4 indicating complete loss of joint space, bony ankylosis or luxation. JSN scores ranged from 0-168. A score of 0 would indicate no change and higher scores represent a worsening of joint space narrowing.
The bone erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints of the feet. Each joint is scored according to the surface area involved from 0 to 5 for hand joints and 0 to 10 for the foot joints, with 0 indicating no erosion and the highest score (5 for the hand and 10 for the foot) indicating extensive loss of bone from more than one half of the articulating bone. Erosion scores ranged from 0 (no erosion) to 280 (high erosion)."|Baseline, Week 24, Week 52|mITT population: all randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-baseline assessment. Missing values due to discontinuation of study, rescue, or missing data were imputed using LE.||units on a scale||Standard Deviation|Mean
669546|NCT01710358|Secondary|Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Scores|The Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) questionnaire was developed to measure the effect of general health and symptom severity on work productivity and regular activities in the 7 days prior to the visit. It contains 6 items covering overall work productivity (health), overall work productivity (symptom), impairment of regular activities (health), and impairment of regular activities (symptom). Scores are calculated as impairment percentages. The WPAI-RA yields four types of scores: Absenteeism (work time missed), Presenteeism (impairment at work), Work productivity loss (overall work impairment), and Activity impairment.|Baseline, Week 12, Week 24, Week 52|mITT population includes all randomized participants who received at least 1 dose of the study drug, with a baseline value and an observed value at the time point being summarized.||percentage of impairment||Standard Deviation|Mean
669547|NCT01710358|Secondary|Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores (Self-Perceived Health)|A second component of the EQ-5D-5L is a self-perceived health score which is assessed using a VAS that ranges from 0 to 100 millimeter (mm), where 0 indicates the worst health you can imagine and 100 indicates the best health you can imagine.|Baseline, Week 12, Week 24, Week 52|mITT population: all randomized participants who received at least 1 dose of study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.||millimeter||Standard Deviation|Mean
669548|NCT01710358|Secondary|Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores|European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. One component consists of a descriptive system of the respondent's health comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1. A higher score indicates better health state.|Baseline, Week 12, Week 24, Week 52|mITT population: all randomized participants who received at least 1 dose of study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.||units on a scale||Standard Deviation|Mean
669549|NCT01710358|Secondary|Change From Baseline in Mental Component Score (MCS), Physical Component Score (PCS) of the Medical Outcomes Study 36-Item Short Form Health Survey Version 2 Acute (SF-36v2 Acute)|The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (mental [MCS] and physical [PCS]). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status or functioning.|Baseline, Week 12, Week 24, Week 52|mITT population: all randomized participants who received at least 1 dose of study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.||units on a scale||Standard Deviation|Mean
669550|NCT01710358|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale Scores|"The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale is a brief 13-item, symptom-specific questionnaire that specifically assesses the participant's self-reported severity of fatigue and its impact upon daily activities and functioning. The FACIT-F uses a numeric rating scale of 0 (Not at all) to 4 (Very much) for each item to assess fatigue and its impact in the past 7 days. Total scores range from 0 to 52, with higher scores indicating less fatigue."|Baseline, Week 12, Week 24, Week 52|mITT population: all randomized participants who received at least 1 dose of study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.||units on a scale||Standard Deviation|Mean
669551|NCT01710358|Secondary|Mean Worst Joint Pain NRS in the Prior 7 Days as Collected in Electronic Diaries|"Participants rated their joint pain by selecting a number from 0 to 10 that best described their worst joint pain during the last 24 hours, where 0 represents no pain and 10 represents pain as bad as you can imagine. Participants reported their worst joint pain in daily electronic diaries. The average value across the 7 days preceding each visit was calculated."|Week 12|mITT population: all randomized participants who received at least 1 dose of the study drug and had at least 4 entries within any post-baseline 7-day window are included in the analysis.||units on a scale||Standard Deviation|Mean
669596|NCT01710033|Primary|Mycophenolic Acid (MPA) Plasma Trough Concentration at Baseline|Pro-drug MMF was metabolically converted to active form MPA in the liver. The baseline for MPA trough concentrations was defined as the average of the values obtained at Screening and on Day 1 (pre-dose). MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure.|Screening, 0 hour (pre-dose) on Day 1|Analysis population included all randomized participants who received at least 1 dose of study treatment.||Milligram per Liter (mg/L)||Standard Deviation|Mean
669552|NCT01710358|Secondary|Mean Worst Tiredness Numeric Rating Scale (NRS) in the Prior 7 Days as Collected in Electronic Diaries|"Participants rated their tiredness by selecting a number from 0 to 10 that best described their worst tiredness during the last 24 hours, where 0 represents no tiredness and 10 represents as bad as you can imagine. Participants reported their worst tiredness in electronic diaries. The average value across the 7 days preceding each visit is calculated."|Week 12|mITT population: all randomized participants who received at least 1 dose of the study drug and had at least 4 entries within any post-baseline 7-day window are included in the analysis.||units on a scale||Standard Deviation|Mean
669553|NCT01710358|Secondary|Mean Severity of Morning Joint Stiffness Numeric Rating Scale (NRS) in the Prior 7 Days as Collected in Electronic Diaries|"Participants rated the severity of their morning joint stiffness by selecting a number from 0 to 10 that best described their overall level of morning joint stiffness from the time they woke up, where 0 represents no joint stiffness and 10 represents joint stiffness as bad as you can imagine. Participants reported their severity daily in electronic diaries. The average value across the 7 days preceding each visit was calculated."|Week 12|mITT population: all randomized participants who received at least 1 dose of the study drug and had at least 4 entries within any post-baseline 7-day window are included in the analysis.||units on a scale||Standard Deviation|Mean
669554|NCT01710358|Secondary|Median of Individual Participant Mean Duration of Morning Joint Stiffness in the Prior 7 Days as Collected in Electronic Diaries|Participants recorded the duration of their morning joint stiffness (MJS) in hours and minutes into electronic diaries daily. If morning joint stiffness duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. The average value across the 7 days preceding each visit was calculated. A decrease in duration of morning joint stiffness indicated an improvement in the participant's condition.|Week 12|mITT population: all randomized participants who received at least 1 dose of the study drug and had at least 4 entries within any post-baseline 7-day window are included in the analysis.||Minutes||95% Confidence Interval|Median
669555|NCT01710358|Secondary|Percentage of Participants Achieving American College of Rheumatology European League Against Rheumatism (ACR/EULAR) Remission – Boolean Remission|The ACR/EULAR definitions of RA remission includes a Boolean-based definition. The Boolean-based definition of remission occurs when all 4 of the following criteria are met at the same visit: TJC28 ≤1, SJC28 ≤1, acute phase response using C-reactive protein (milligrams per deciliter) ≤1, Patient's Global Assessment of Disease Activity using VAS (cm) ≤1.|Week 12, Week 24, Week 52|mITT population: all randomized participants who received at least 1 dose of study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.||percentage of participants|||Number
669556|NCT01710358|Secondary|Percentage of Participants Achieving Simplified Disease Activity Index (SDAI) Score ≤3.3|SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Patient's Global Assessment of Disease Activity using VAS centimeters (cm), and Physician's Global Assessment of Disease Activity using VAS (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity. An index-based definition of remission occurs with an SDAI score ≤3.3.|Week 12, Week 24, Week 52|mITT population: all randomized participants who received at least 1 dose of study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.||percentage of participants|||Number
669557|NCT01710358|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) Score|The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition.|Baseline, Week 12, Week 24, Week 52|mITT population: all randomized participants who received at least 1 dose of the study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using modified last observation carried forward (mLOCF).||units on a scale||Standard Deviation|Mean
669558|NCT01710358|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) and 70% (ACR70) Response|"ACR50 and ACR70 Responder Index is a composite of clinical, laboratory, and functional measures in RA. ACR50 and ACR70 Responder is a participant who has at least 50% or 70% improvement, respectively, in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, HAQ-DI, pain due to arthritis, and hsCRP.
Participants with missing responses and participants who discontinued study or drug or were rescued before analysis time point were deemed non-responders."|Week 12, Week 24, Week 52|mITT population: all randomized participants who received at least 1 dose of the study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.||percentage of participants|||Number
669559|NCT01710358|Secondary|Change From Baseline in the Disease Activity Score Based on a 28-Joint Count and High-sensitivity C-reactive Protein (DAS28-hsCRP)|Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), C-reactive protein (CRP) (milligrams per liter), and Patient's Global Assessment of Disease Activity using visual analog scale (VAS) (participant global VAS). DAS28 was calculated using following formula: DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*Patient's Global VAS+0.96. Scores ranged 1.0-9.4, where lower scores indicated less disease activity.|Baseline, Week 12|mITT population includes all randomized participants who received at least 1 dose of the study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mBOCF.||units on a scale||Standard Deviation|Mean
669767|NCT01709305|Secondary|Percentage of Participants With a GI AE of Abdominal Pain (Phase 2)|"The percentage of participants with a GI AE of abdominal pain was reported."|From Week 20 through Week 44|All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment and were compliant with GCP requirements.||Percentage of Participants|||Number
669560|NCT01710358|Secondary|Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score|The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty (0 [without any difficulty], 1 [with some difficulty], 2 [with much difficulty], and 3 [unable to do]) when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate the HAQ-DI score, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.|Baseline, Week 12|mITT population includes all randomized participants who received at least 1 dose of the study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using modified baseline observation carried forward (mBOCF).||units on a scale||Standard Deviation|Mean
669561|NCT01710358|Secondary|Change From Baseline in the Modified Total Sharp Score (mTSS)|"X-rays of the hands/wrists and feet were scored for structural progression as measured using the mTSS. This methodology quantified the extent of bone erosions and joint space narrowing for 44 and 42 joints, with higher scores representing greater damage.
The mTSS at a time point is the sum of the erosion (range from 0 to 280) and JSN (range from 0 to 168) scores, for a maximum score of 448."|Baseline, Week 24|mITT population: all randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-baseline assessments. Missing values due to discontinuation of study, rescue, or missing data were imputed using linear extrapolation (LE).||units on a scale||Standard Deviation|Mean
669562|NCT01710358|Primary|Percentage of Participants Achieving American College of Rheumatology 20% Improvement (ACR20)|"ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). ACR20 Responder is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity using visual analog scale (VAS), Health Assessment Questionnaire-Disability Index (HAQ-DI), pain due to arthritis, and high-sensitivity C-reactive protein (hsCRP). Participants with missing responses and participants who discontinued study or drug or were rescued before analysis timepoint were deemed non-responders."|Week 12|Modified Intent-to-Treat (mITT) population: all randomized participants who received at least 1 dose of study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using nonresponder imputation (NRI).||percentage of participants|||Number
669563|NCT01710345|Primary|SPID-12|"The primary outcome measure is the summed pain intensity difference over the 12-hour study period (SPID-12). A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and throughout the 12 hour study period. The SPID-12 is calculated by summing the difference between baseline pain score and pain score at each assessment time point.
The SPID-12 ranges from -120 (indicative of an increase in pain) to 120 (indicative of a decrease in pain). A higher SPID-12 score is better."|12 hours|||units on a scale||Standard Error|Least Squares Mean
669564|NCT01710332|Secondary|Change in Vision Based on Letter Score|• Mean change from baseline in best-corrected ETDRS (Early Treatment of Diabetic Retinopathy Study) letter score|6 months|||ETDRS letters||Standard Deviation|Mean
669565|NCT01710332|Primary|Safety of Intravitreal Aflibercept Injection|Safety will be measured by the amount, significance and details of adverse events/reactions to the study drug.|6 months|||adverse events|||Number
670088|NCT01704495|Primary|Rate of Severe Asthma Exacerbations During 6 Months||From start of treatment up to 6 months|Full analysis set||Exacerbations per 6 month||90% Confidence Interval|Least Squares Mean
669582|NCT01710033|Primary|Tacrolimus (TAC) Plasma Trough Concentration at Day 57|TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.|0 hour (pre-dose) on Day 57|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."||ng/mL||Standard Deviation|Mean
669583|NCT01710033|Primary|Tacrolimus (TAC) Plasma Trough Concentration at Day 29|TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.|0 hour (pre-dose) on Day 29|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."||ng/mL||Standard Deviation|Mean
669584|NCT01710033|Primary|Tacrolimus (TAC) Plasma Trough Concentration at Day 15|TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.|0 hour (pre-dose) on Day 15|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."||ng/mL||Standard Deviation|Mean
669585|NCT01710033|Primary|Tacrolimus (TAC) Plasma Trough Concentration at Day 8|TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.|0 hour (pre-dose) on Day 8|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."||ng/mL||Standard Deviation|Mean
669586|NCT01710033|Primary|Tacrolimus (TAC) Plasma Trough Concentration at Baseline|The baseline for TAC trough concentrations was defined as the average of the values obtained at Screening and on Day 1 (pre-dose). TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.|Screening, 0 hour (pre-dose) on Day 1|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."||ng/mL||Standard Deviation|Mean
669587|NCT01710033|Primary|Cyclosporine (CsA) Plasma Trough Concentration at Day 57|CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.|0 hour (pre-dose) on Day 57|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."||ng/mL||Standard Deviation|Mean
669588|NCT01710033|Primary|Cyclosporine (CsA) Plasma Trough Concentration at Day 29|CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.|0 hour (pre-dose) on Day 29|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."||ng/mL||Standard Deviation|Mean
669589|NCT01710033|Primary|Cyclosporine (CsA) Plasma Trough Concentration at Day 15|CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.|0 hour (pre-dose) on Day 15|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."||ng/mL||Standard Deviation|Mean
669590|NCT01710033|Primary|Cyclosporine (CsA) Plasma Trough Concentration at Day 8|CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.|0 hour (pre-dose) on Day 8|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."||ng/mL||Standard Deviation|Mean
669591|NCT01710033|Primary|Cyclosporine (CsA) Plasma Trough Concentration at Baseline|The baseline for CsA trough concentrations was defined as the average of the values obtained at Screening and on Day 1 (pre-dose). CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.|Screening, 0 hour (pre-dose) on Day 1|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."||ng/mL||Standard Deviation|Mean
669592|NCT01710033|Primary|Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 57|Pro-drug MMF was metabolically converted to active form MPA in the liver. MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure.|0 hour (pre-dose) on Day 57|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."||mg/L||Standard Deviation|Mean
669593|NCT01710033|Primary|Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 29|Pro-drug MMF was metabolically converted to active form MPA in the liver. MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure.|0 hour (pre-dose) on Day 29|Analysis population included all randomized participants who received at least 1 dose of study treatment.||mg/L||Standard Deviation|Mean
669594|NCT01710033|Primary|Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 15|Pro-drug MMF was metabolically converted to active form MPA in the liver. MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure.|0 hour (pre-dose) on Day 15|Analysis population included all randomized participants who received at least 1 dose of study treatment.||mg/L||Standard Deviation|Mean
669595|NCT01710033|Primary|Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 8|Pro-drug MMF was metabolically converted to active form MPA in the liver. MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure.|0 hour (pre-dose) on Day 8|Analysis population included all randomized participants who received at least 1 dose of study treatment.||mg/L||Standard Deviation|Mean
669597|NCT01710033|Primary|Plasma Decay Half-Life (t1/2) at Steady State For CP-690,550|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half at steady state.|0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."||hours||Standard Deviation|Mean
669598|NCT01710033|Primary|Plasma Decay Half-Life (t1/2) For CP-690,550|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."||hours||Standard Deviation|Mean
669599|NCT01710033|Primary|Accumulation Ratio (Rac) For CP-690,550|Rac obtained from AUC(0-12) (Day 29) divided by AUC(0-12) (Day 1).|0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1 and 29|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."||ratio||Standard Deviation|Mean
669600|NCT01710033|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) at Steady State For CP-690,550||0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."||hours||Full Range|Median
669601|NCT01710033|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) For CP-690,550||0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."||hours||Full Range|Median
669602|NCT01710033|Primary|Maximum Observed Plasma Concentration (Cmax) at Steady State For CP-690,550||0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."||ng/mL||Standard Deviation|Mean
669603|NCT01710033|Primary|Maximum Observed Plasma Concentration (Cmax) For CP-690,550||0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
669604|NCT01710033|Primary|Area Under the Curve From Time Zero to 12 Hour Concentration [AUC(0-12)] at Steady State For CP-690,550|Area under the plasma concentration time-curve from zero to 12 hour concentration [AUC(0-12)] at steady state.|0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 29|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."||ng*hr/mL||Standard Deviation|Mean
669605|NCT01710033|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) at Steady State For CP-690,550|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) at steady state.|0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."||ng*hr/mL||Standard Deviation|Mean
669606|NCT01710033|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) For CP-690,550|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).|0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."||nanogram*hour per milliliter (ng*hr/mL)||Standard Deviation|Mean
669607|NCT01710020|Other Pre-specified|Dialyser Clearance (CL HD) From 3 to 3.5 Hour|Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu*Cmid*tm).|3 to 3.5 hrs during hemodialysis started 4 hrs post-dose in Period 2|Analysis set included all participants who received study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||mL/min||Standard Deviation|Mean
669608|NCT01710020|Other Pre-specified|Overall Dialyser Clearance (CL HD)|Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu*Cmid*tm).|0 to 4 hrs during hemodialysis started 4 hrs post-dose in Period 2|Analysis set included all participants who received study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||mL/min||Standard Deviation|Mean
669609|NCT01710020|Secondary|Fraction of Unbound Drug (fu)|Fraction of unbound drug (fu) is defined as the ratio of unbound drug concentration to the total drug concentration.|2 hours post-dose in Period 1|Analysis set included all participants who received study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||ratio||Standard Deviation|Mean
669610|NCT01710020|Primary|Dialyser Clearance (CL HD) From 3 to 4 Hour|Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu*Cmid*tm).|3 to 4 hrs during hemodialysis started 4 hrs post-dose in Period 2|Analysis set included all participants who received study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||mL/min||Standard Deviation|Mean
669657|NCT01709708|Secondary|Modified Pain Characteristic Questionnaire|Compare Modified Pain Characteristic Questionnaire scores Before Procedure vs. 24-Hour After Procedure, Before Procedure vs. 1-Month Follow Up, and Before Procedure vs. 6-Month Follow Up (Group A vs. Group B). The modified pain characteristic questionnaire is a series of 11 questions on a likert scale ranging from 0 to 10 with 0 being no pain or does not interfere and 10 being worst pain or completely interferes.|6 Months||||||
669611|NCT01710020|Primary|Dialyser Clearance (CL HD) From 2 to 3 Hour|Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu*Cmid*tm).|2 to 3 hrs during hemodialysis started 4 hrs post-dose in Period 2|Analysis set included all participants who received study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||mL/min||Standard Deviation|Mean
669612|NCT01710020|Primary|Dialyser Clearance (CL HD) From 1 to 2 Hour|Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu*Cmid*tm).|1 to 2 hrs during hemodialysis started 4 hrs post-dose in Period 2|Analysis set included all participants who received study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||mL/min||Standard Deviation|Mean
669613|NCT01710020|Primary|Dialyser Clearance (CL HD) From 0 to 1 Hour|Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided (/) by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu*Cmid*tm).|0 to 1 hrs during hemodialysis started 4 hrs post-dose in Period 2|Analysis set included all participants who received study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||mL/min||Standard Deviation|Mean
669614|NCT01710020|Primary|Oral Clearance (CLpo)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. It was calculated by dividing given dose of drug with AUC.|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hrs post-dose in Period 1|Analysis set included all participants who received study medication.||milliliter/minute (mL/min)||Standard Deviation|Mean
669615|NCT01710020|Primary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hrs post-dose in Period 1|Analysis set included all participants who received study medication.||hr||Standard Deviation|Mean
669616|NCT01710020|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hrs post-dose in Period 1|Analysis set included all participants who received study medication.||hr||Full Range|Median
669617|NCT01710020|Primary|Maximum Observed Plasma Concentration (Cmax)||0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hrs post-dose in Period 1|Analysis set included all participants who received study medication.||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
669618|NCT01710020|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hrs post-dose in Period 1|Analysis set included all participants who received study medication.||ng*hr/mL||Standard Deviation|Mean
669619|NCT01710020|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hours (hrs) post-dose in Period 1|Analysis set included all participants who received study medication.||nanogram*hour/milliliter (ng*hr/mL)||Standard Deviation|Mean
669620|NCT01709903|Secondary|Symptoms Reported Using E-diary Over 12 and 26 Weeks of Treatment|Percentage of nights with 'no nighttime awakenings', percentage of days with 'no daytime symptoms', and percentage of 'days able to perform usual daily activities' over 26 weeks (FAS)|26 weeks|Full Analysis Set||% days in study||Standard Error|Least Squares Mean
669621|NCT01709903|Secondary|Rescue Medication Use: Summary of the Mean Daily, Daytime and Nighttime Number of Puffs of Rescue Medication, by 4 Weekly Intervals|"The number of puffs of rescue medication taken in the previous 12 hours will be recorded in the Patient Diary in the morning and evening. Baseline 12 weeks and Baseline 26 weeks, were the baseline scores for available participants analyzed for each time point. Less puffs taken is better."|12 and 26 weeks|Full Analysis set||# of puffs||Standard Deviation|Mean
669622|NCT01709903|Secondary|Analysis of the TDI Focal Score Over the Whole Treatment Period|"The Transition Dyspnea Index (TDI) total score after 12 and 26 weeks of treatment will be analyzed using the same mixed model as specified for the primary analysis with the Baseline Dyspnea Index (BDI) total score as the baseline.Total score ranging - 9 to + 9. The lower the score, the more deterioration in severity of dyspnea. One additional option in each category, which does not contribute to the score, allows for circumstances in which impairment is due to reasons other than dyspnea. .Baseline 12 weeks and Baseline 26 weeks, were the baseline scores for available participants analyzed for each time point."|12 and 26 weeks|Full Analysis Set||Numbers on a scale||Standard Error|Least Squares Mean
669623|NCT01709903|Secondary|Health Related Quality of Life Analysis of SGRQ Total Score After 26 Weeks of Treatment|A Total and three component scores are calculated: Symptoms; Activity; Impacts. Each component of the questionnaire is scored separately:The score for each component is calculated separately by dividing the summed weights by the maximum possible weight for that component and expressing the result as a percentage: Score = 100 x Summed weights from all positive items in that component divided by Sum of weights for all items in that component The Total score is calculated in similar way: Score = 100 x Summed weights from all positive items in the questionnaire divided by Sum of weights for all items in the questionnaire Sum of maximum possible weights for each component and Total: Symptoms 566.2 Activity 982.9 Impacts 1652.8 Total (sum of maximum for all three components) 3201.9 The proportion of patients who achieve a clinically important improvement of at least 4 units in the total SGRQ will be analyzed. The higher the score the more symptoms of disease are present.|26 weeks|Full Analysis set||numbers on a scale||Standard Error|Mean
669624|NCT01709903|Secondary|Analysis of Trough FVC (L) Over the Whole Treatment Period|Average of Trough Forced Vital Capacity (FVC) at 23 hours 15 min and the 23 hours 45 min post dose|12 and 26 weeks|Full Analysis Set||liter||Standard Error|Least Squares Mean
669625|NCT01709903|Secondary|Analysis of FEV1 (L) Trough Response (Pre-dose) Over the Whole Treatment Period|Average of Trough Forced Expiratory Volume in one second (FEV1)|6,12,18 and 26 weeks|Full analysis set||liter||Standard Error|Least Squares Mean
669626|NCT01709903|Secondary|Standardized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-4 Hours|Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) 0-4h at Day 1 was measured via spirometry conducted according to internationally accepted standards. Measurements were made at 0, 5, 15, and 30 minutes; and 1, 2, 3 and 4 hours post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time. Mixed model used: AUC FEV1 = treatment + baseline FEV1 + FEV1 reversibility components + baseline smoking status + baseline ICS use + country + center (country) + error. Center was included as a random effect nested within country.|Day 1, 12 and 26 weeks|Full Analysis set||Liter||Standard Deviation|Mean
669627|NCT01709903|Secondary|Trough Forced Expiratory Volume in One Second (FEV1) Following 26 Weeks of Treatment to Demonstrate the Superiority of QVA 110/50μg o.d. to Fluticasone/Salmeterol 500/50 μg b.i.d||26 weeks|FAS||liters||Standard Error|Least Squares Mean
669628|NCT01709903|Primary|Trough Forced Expiratory Volume in One Second (FEV1) Following 26 Weeks of Treatment to Demonstrate the Non-inferiority of QVA149 110/50 μg o.d. to Fluticasone/Salmeterol 500/50 μg b.i.d|Measurement of QVA149 110/50 μg o.d. to fluticasone/salmeterol 500/50 μg b.i.d. in terms of trough FEV1 (mean of 23 h 15 min and 23 h 45 min post QVA149 dose) following 26 weeks of treatment in patients with moderate to severe COPD.|26 weeks|FAS||liters||Standard Error|Least Squares Mean
669629|NCT01709864|Secondary|Change From Baseline of Forced Expiratory Volume in One Second (FEV1) at All Individual Timepoints at Day 1 and at Week 12 (Day 85)|The Forced Expiratory Volume in one second (FEV1) assessments for all individual time points of the serial measurements on day 1 and at week 12 are analyzed.|Baseline, Day 1 and Week 12 (Day 85)|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug. Following the intent-to -treat principle, patients were analyzed according to the treatment they were assigned to at randomization.||liters||Standard Error|Least Squares Mean
669630|NCT01709864|Secondary|Change From Baseline of Forced Vital Capacity (FVC) at All Individual Timepoints at Day 1 and at Week 12 (Day 85)|The Forced Vital Capacity (FVC) assessments for all individual time points of the serial measurements on day 1 and at week 12 are analyzed.|Baseline, Day 1 and Week 12 (Day 85)|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug. Following the intent-to -treat principle, patients were analyzed according to the treatment they were assigned to at randomization.||liters||Standard Error|Least Squares Mean
669631|NCT01709864|Secondary|Percentage of Days Without Rescue Medication Use|Patients report the number of puffs of rescue medication (salbutamol / albuterol) using an electronic diary. The use of rescue medication is analyzed as the percentage of days without usage of rescue medication over the 12 weeks treatment period. The baseline is calculated from the run-in epoch prior to randomization.|12 weeks|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. week 12||percentage of days||Standard Error|Least Squares Mean
669632|NCT01709864|Secondary|The Average Number of Puffs of Rescue Medication Per Day|Patients report the number of puffs of rescue medication (salbutamol / albuterol) using an electronic diary. The use of rescue medication is analyzed as the mean daily number of puffs used per patient over the 12 weeks treatment period.|baseline and 12 weeks|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. Week 12||number of puffs||Standard Error|Least Squares Mean
669633|NCT01709864|Secondary|"Percentage of Days Able to Perform Usual Daily Activities"|"Patients are reporting symptoms by using an electronic diary. A day able to perform usual daily activities is defined from diary data as any day where the patient was not prevented from performing their usual daily activities due to respiratory symptoms."|from Baseline up to 12 weeks|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug. Following the intent-to -treat principle, patients were analyzed according to the treatment they were assigned to at randomization||pecentage of days||Standard Error|Least Squares Mean
669634|NCT01709864|Secondary|"Percentage of Days With no Daytime Symptoms"|"Patients are reporting symptoms by using an electronic diary. A day with no daytime symptoms is defined from diary data as any day where the patient has recorded in the evening no cough, no wheeze, no production of sputum, and no feeling of breathlessness (other than when running) during the past approximately 12 hours. The percentage of days is calculated by the number of days with no daytime symptoms/total number of days with evaluable data X 100."|from Baseline up to 12 weeks|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug. Following the intent-to -treat principle, patients were analyzed according to the treatment they were assigned to at randomization||percentage of days||Standard Error|Least Squares Mean
669635|NCT01709864|Secondary|"Percentage of Nights With no Nighttime Awakenings"|"Patients are reporting symptoms by using an electronic diary. A night with no nighttime awakening is defined from diary data as any night where the patient did not wake up due to symptoms. Percentage of no nighttime awakenings from Baseline up to 12 weeks."|from Baseline up to 12 weeks|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug. Following the intent-to -treat principle, patients were analyzed according to the treatment they were assigned to at randomization||percentage of nights||Standard Error|Least Squares Mean
669643|NCT01709864|Primary|Change From Baseline of Standardized Area Under the Curve (AUC) for Forced Expiratory Volume in One Second (FEV1) Post Dosing|The standardized Area Under the Curve (AUC) for Forced Expiratory Volume in one second (FEV1) post dosing (FEV1 AUC) at week 12 of treatment. Serial lung function measurements are taken at various time points following dosing at week 12 to calculate the AUC.|12 weeks|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. analyzed participants had values at both baseline and the corresponding time frame, i.e. week 12||liters*hr||Standard Error|Least Squares Mean
669658|NCT01709708|Secondary|Patient's Global Impression of Change (PGIC)|Compare 24-Hour After Procedure Patient's Global Impression of Change (PGIC) score for 12 treatments (Group A vs. Group B). PGIC is a likert scale ranging from 1 to 7 with 1 being very much improved and 7 being very much worse.|Estimated 6 Weeks||||||
679158|NCT01587079|Primary|FEV1 AUC 0-12 on Day 7|FEV1 AUC 0-12|Day 7|MITT||Liters||95% Confidence Interval|Least Squares Mean
669636|NCT01709864|Secondary|Change From Baseline of Morning and Nighttime Symptom Scores at Week 12|Patients reported symptoms using an electronic diary.The diary has 9 symptom questions each am & each pm.Each question can be answered w/1 of 4 pre-defined answers,with a unit value of 0-3, 0 is least & 3 is most severe symptom.Symptom scores are calculated as the mean of the symptom scores(either the score assessed in am for the previous 12 hrs-referred to as nighttime scores,or the score assessed in pm for the previous 12 hrs-referred to as the daytime symptom score) for each patient over 12 weeks.The baseline is calculated from the run-in epoch prior to randomization.The change from baseline is in LS mean daily symptom scores over the 12 weeks. If the mean score over the 12 weeks is lower than the baseline, result is (-).A neg. result indicates an improvement in COPD symptom severity. the # of patients analyzed can vary between both day & night scores. Therefore, the # of patients analyzed for the combined daily symptom score can vary from the #s for individual day & night scores.|12 weeks|Participants from the full analysis set (FAS), who had outcome measure data with applicable fixed effects/covariates according to the analysis model, were analyzed only and included all randomized patients who received at least one dose of study drug.||score||Standard Error|Least Squares Mean
669637|NCT01709864|Secondary|Change From Baseline of Daily Symptom Scores|Patients reported symptoms using an electronic diary.The diary has 9 symptom questions each am and each pm. Each question can be answered w/1 of 4 pre-defined answers, with a unit value of 0-3, 0 is least & 3 is most severe symptom.Symptom scores are calculated as the mean of combined daily symptom scores(combined from am & pm)for each patient over 12 weeks. The baseline is calculated from the run-in epoch prior to randomization.The change from baseline is in LS mean daily symptom scores over the 12 weeks. If the mean score over the 12 weeks is lower than the baseline, result is (-).A neg. result indicates an improvement in COPD symptom severity. Patients may have met the min. response requirements for the night scores(am questions),but not for the day scores(pm questions)or vice versa, the # of patients analyzed can vary between both day & night scores. Therefore, the # of patients analyzed for the combined daily symptom score can vary from the #s for individual day & night scores.|12 weeks|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame.||Score||Standard Error|Least Squares Mean
669638|NCT01709864|Secondary|Breathlessness Assessed by Transition Dyspnea Index (TDI) Focal Score at Week 12|Breathlessness at week 12 is measured using the Transition Dyspnea Index (TDI). On day 1, breathlessness is assessed by the Baseline Dyspnea Index (BDI). Patients are considered to have clinically significant improvement with the TDI score change versus BDI being equal to or greater than 1. TDI focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort. Each domain is scored from -3 (major deterioration) to 3 (major improvement) to give an overall TDI focal score of -9 to 9. Higher numbers indicate a better score.|Week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. Week 12||scores on a scale||Standard Error|Least Squares Mean
669639|NCT01709864|Secondary|Percentage of Participants With a Clinically Important Improvement of >=4units in the SGRQ Total Score at Week 12|The health status, as reported by the patients, is assessed using the St. George’s Respiratory Questionnaire (SGRQ). The assessment is based on total score as well as the percentage of patients with clinically significant improvement at week 12 versus day 1. A clinically significant improvement in SGRQ is defined as less than or equal to -4 change from baseline.|Week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame.||percentage of participants|||Number
669640|NCT01709864|Secondary|Change From Baseline in the Health Status Assessed by St. George’s Respiratory Questionnaire|The health status, as reported by the patients, is assessed using the St. George's Respiratory Questionnaire (SGRQ). The SGRQ is a 50 item scale assessing symptoms, patient activities and impact of the disease. Scores range from 0 to 100 units, with higher scores indicating more limitations. The assessment is based on total score as well as the percentage of patients with clinically significant improvement at week 12 versus day 1. A clinically meaningful improvement (MCID) in SGRQ is defined as a decrease of 4 or more units of the SGRQ scale in the total score, as compared to baseline (change from baseline).|Week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. Week 12||score||Standard Error|Least Squares Mean
669641|NCT01709864|Secondary|Change From Baseline in FEV1 AUC (0-12H) at Day 1 and FEV1 AUC (0-4h), AUC (4-8h), AUC (8-12h) at Day 1 and Week 12 (Day 85)|The standardized Area Under the Curve (AUC) for Forced Expiratory Volume in one second (FEV1) is assessed for different time spans within the overall serial measurement post dosing (FEV1 AUCs Time Spans), at day 1 and at week 12 of treatment. Serial lung function measurements are taken at various time points post dosing on day 1 and at week 12 to calculate the AUC for these different time spans.|Day 1 and Week 12 (Day 85)|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. Day 1and Week 12||liters*hr||Standard Error|Least Squares Mean
669642|NCT01709864|Secondary|Change From Baseline in Trough FEV1 and Pre-dose Trough FEV1 by Visit|Trough Forced Expiratory Volume in one second (FEV1) is the mean of FEV1 at 23h 15min and 23h 45min after the morning dose of the previous day. Pre-dose trough FEV1 is the mean of FEV1 at -45min and -15min before morning dose|Day 2, 86 (trough) Day 15, 29, 57, 85 (pre-dose trough)|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame.||liters||Standard Error|Least Squares Mean
669654|NCT01709708|Secondary|Adverse Events|Number of adverse events over the entire length of study (Group A vs. Group B).|Estimated 14 weeks||||||
669644|NCT01709799|Secondary|Timed Instrumental Activities of Daily Living Task|"The TIADL consists of five timed instrumental activities of daily (TIADL) tasks. The score that is generated is the total time required to perform the tasks (e.g., finding a telephone number, making change, finding and reading the ingredients on a can of food, finding food items on a shelf, reading instructions on medicine container). Thus LOWER SCORES are indicative of IMPROVEMENT.
These scores have been converted to T-scores (standardized scores with an average of 50 and standard deviation of 10). The formula used was:
T-score = ((((participant score minus sample mean at baseline) / (sample standard deviation at baseline) ) * 10) + 50)"|Baseline (Week 0), immediate posttest (Week 16), delayed posttest (Week 28)|||T-score units||Standard Error|Mean
669645|NCT01709799|Primary|Sweep Seeker Subtest of PositScience Insight|"Participants watch two patterns that “sweep” in or out and identify their direction. The test measures visual processing speed. As participants master the task it is made more difficult via: (a) the colors of the sweeps change, (b) the direction of the sweeps change, and (c) the thickness of the bars change. Participants' scores are in milliseconds. As participants improve, the visual sweeps speed up, giving participants a lower (better) score. Thus LOWER SCORES are indicative of IMPROVEMENT.
These scores have been converted to T-scores (standardized scores with an average of 50 and standard deviation of 10). The formula used was:
T-score = ((((participant score minus sample mean at baseline) / (sample standard deviation at baseline) ) * 10) + 50)"|Baseline (Week 0), immediate posttest (Week 16), delayed posttest (Week 28)|||T-score units||Standard Error|Mean
669646|NCT01709799|Primary|Road Tour Subtest of PositScience Insight|"Participants choose which car they saw at the center of the screen, and also locate where a Route 66 sign appeared in the periphery. This is a measure of useful field of view and visual processing speed. As participants master the task, it is made more difficult via: (a) distractors are added, (b) distance from the center increases, (c) cars get more similar, and (d) backgrounds get more complex. Score is in milliseconds. As participants improve, the cars and road signs flash for fewer milliseconds, giving them a lower (better) score. Thus LOWER SCORES are indicative of IMPROVEMENT.
These scores have been converted to T-scores (standardized scores with an average of 50 and standard deviation of 10). The formula used was:
T-score = ((((participant score minus sample mean at baseline) / (sample standard deviation at baseline) ) * 10) + 50)"|Baseline (Week 0), immediate posttest (Week 16), delayed posttest (Week 28)|||T-score units||Standard Error|Mean
669647|NCT01709799|Primary|Master Gardener Subtest of PositScience Insight|"Participants watch as three or five images briefly flash in different positions on screen. This task measures visual processing speed and visual working memory. As participants master the task, it is made more difficult via: (a) the images change, becoming more similar, (b) the images are shown over a larger area on screen, and (c) participants go from viewing 3 images to 5 images. Participant score is in milliseconds, so that as they improve, the images flash on screen for fewer milliseconds. Thus LOWER SCORES are indicative of IMPROVEMENT.
These scores have been converted to T-scores (standardized scores with an average of 50 and standard deviation of 10). The formula used was:
T-score = ((((participant score minus sample mean at baseline) / (sample standard deviation at baseline) ) * 10) + 50)"|Baseline (Week 0), immediate posttest (Week 16), delayed posttest (Week 28)|||T-score units||Standard Error|Mean
669648|NCT01709799|Primary|Jewel Diver Subtest of PositScience Insight|"Participants track target objects as they move around the screen. This is a measure of divided attention. As participants master the task, it is made more difficult in that: (a) objects travel more quickly, (b) objects travel over larger area, (c) objects travel for longer, (d) visual contrast decreases. The score is the number of objects participants are able to track. Thus, HIGHER SCORES reflect IMPROVEMENT
These scores have been converted to T-scores (standardized scores with an average of 50 and standard deviation of 10). The formula used was:
T-score = ((((participant score minus sample mean at baseline) / (sample standard deviation at baseline) ) * 10) + 50)"|Baseline (Week 0), immediate posttest (Week 16), delayed posttest (Week 28)|||T-score units||Standard Error|Mean
669649|NCT01709799|Primary|Bird Safari Subtest of PositScience Insight|"Participants identify the bird that is different from the others as it flashes briefly on screen. The test measures visual speed and precision. The test is adaptive, and becomes more difficult with practice in that bird pairs get more similar, backgrounds get more complex, and distance from the center increases. The raw score is in milliseconds. As participants improve, the birds flash for fewer milliseconds, giving them a lower (better) score. Thus, LOWER SCORES reflect IMPROVEMENT
These scores have been converted to T-scores (standardized scores with an average of 50 and standard deviation of 10). The formula used was:
T-score = ((((participant score minus sample mean at baseline) / (sample standard deviation at baseline) ) * 10) + 50)"|Baseline (Week 0), immediate posttest (Week 16), delayed posttest (Week 28)|||T-score units||Standard Error|Mean
669650|NCT01709786|Primary|CBC Hemoglobin Measurement Compared to Non-invasive iSTAT Measurement|"When blood was drawn for laboratory measurement of serum hemoglobin, one drop of blood was used to make point of care measurements using the CBC and iSTAT methods.
For purposes of reporting outcomes measures, we took an equally weighted average of measurements on each device (i.e., all measurement occasions on all patients). These are the means reported in the Outcome Measures Data Table."|n ≥ 1 measurements were taken each day. All measurements (n ≥ 7) from ICU Days 1-7 were used in Bland-Altman analysis, equally weighted.|||grams per deciliter||95% Confidence Interval|Mean
669651|NCT01709786|Primary|CBC Hemoglobin Measurement Compared to Non-invasive Radical-7 Measurement|"Whenever blood was drawn for laboratory measurement of serum hemoglobin, we used one drop of blood to make point-of-care measurements using the CDC and Radical-7 methods.
For purposes of reporting outcomes measures, we took an equally weighted average of measurements on each device (i.e., all measurement occasions on all patients). These are the means reported in the Outcome Measures Data Table."|n ≥ 1 measurements were taken each day. All measurements (n ≥ 7) from ICU Days 1-7 were used in Bland-Altman analysis, equally weighted.|||grams per deciliter||95% Confidence Interval|Mean
669652|NCT01709708|Secondary|Overall Satisfaction|Satisfaction scores Visit 2 vs. following treatment (Treatment 12) and at 1-Month Post-Treatment (Group A vs. Group B). Satisfaction scores are a likert scale ranging from 1 to 5 with 1 being complete dissatisfaction and 5 being complete satisfaction.|Estimated 10 Weeks||||||
669653|NCT01709708|Secondary|Headache Impact Test (HIT-6)|Headache Impact Test (HIT-6) scores Pre-Treatment at Visit 2 vs. Post-Treatment (following final treatment), and at 1-Month Post-Treatment (Group A vs. Group B). HIT-6 is a series of 6 likert scale questions ranging from 1 to 5 with 1 being never and 5 being always.|Estimated 10 Weeks||||||
669660|NCT01709708|Primary|Numeric Rating Scale (NRS)|Compare Numeric Rating Scale (NRS) scores Before Procedure,15-Minute Post Treatment, 30-Minutes Post Treatment, 24-Hour Post Treatment for all 12 treatments (Marcaine vs. Saline). NRS is a likert scale ranging from 0-10 with 0 being no pain and 10 being worst possible pain. For each individual time point, all 12 treatments were averaged for that time point and a single value was used for comparison between the two groups.|Estimated 6 Weeks|||units on a scale||Standard Deviation|Mean
669661|NCT01709578|Secondary|Change From Baseline in Individual ACR Component - HAQ-DI at Week 12 and Week 24|ACR components were: TJC, SJC, physician global VAS, participant global VAS, pain VAS,HAQ-DI & CRP. HAQ-DI consisted of at least 2 questions per category, participant reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week rated on a 4-point scale where 0 = no difficulty; 1 = some difficulty; 2 = much difficulty; 3 = unable to do. Overall score was computed as the sum of category scores and divided by the number of categories answered, ranging from 0 to 3, where 0 = no disability and 3 = unable to do, high-dependency disability. LS mean and SE at Week 12 & 24 by MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline ACR components as a covariate.|Baseline, Week 12 and Week 24|ITT population. Number analyzed = number of participants with HAQ-DI assessment at both baseline and specified time points.||units on a scale||Standard Error|Least Squares Mean
669662|NCT01709578|Secondary|Change From Baseline in Individual ACR Component - CRP Level at Week 12 and Week 24|ACR components were: TJC, SJC, physician global VAS, participant global VAS, pain VAS, HAQ-DI & CRP. An elevated CRP level was considered a non-specific “marker” for RA. A reduction level indicates improvement. LS mean and SE at Week 12 & 24 by MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline ACR components as a covariate.|Baseline, Week 12 and Week 24|ITT population. Number analyzed = number of participants with CRP assessment at both baseline and specified time points.||mg/L||Standard Error|Least Squares Mean
669663|NCT01709578|Secondary|Change From Baseline in Individual ACR Component - Physician Global VAS, Participant Global VAS and Pain VAS at Week 12 and Week 24|ACR components were: TJC, SJC, physician global VAS, participant global VAS, pain VAS, HAQ-DI & CRP. Physician global VAS & participant global VAS was done by 100 mm non-anchored VAS, from no arthritis (0) activity to maximal arthritis (100) activity. Pain VAS by 100 mm VAS ranging from 0 “no pain” to 100 “worst pain”. LS mean and SE at Week 12 & 24 by MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline ACR components as a covariate.|Baseline, Week 12 and Week 24|ITT population. Number analyzed = number of participants with individual ACR components assessment at both baseline and specified time points.||mm||Standard Error|Least Squares Mean
669664|NCT01709578|Secondary|Change From Baseline in Individual ACR Components - TJC and SJC at Week 12 and Week 24|ACR components were: TJC, SJC, physician global VAS, participant global VAS, pain VAS,HAQ-DI & CRP. 68 joints were assessed for tenderness (TJC scoring 0-68) and 66 joints for swelling (SJC scoring 0-66). The 66 SJC evaluated the following joints: temporomandibular, sternoclavicular, acromioclavicular, shoulder, elbow, wrist, metacarpophalangeal, interphalangeal of thumb, distal interphalangeal, proximal interphalangeal, knee, ankle mortise, ankle tarsus, metatarsophalangeal, interphalangeal of great toe, and proximal/distal interphalangeal of the toes. The TJC examined hip joints, in addition to the joints assessed for SJC. Increase in number of tender joints/swollen joints indicated severity. LS mean and SE at Week 12 & 24 by MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline ACR components as a covariate.|Baseline, Week 12 and Week 24|ITT population. Number analyzed = number of participants with TJC and SJC assessments at both baseline and specified time points.||joints||Standard Error|Least Squares Mean
669665|NCT01709578|Secondary|Change From Baseline in RAID Scores at Week 12|RAID score is a composite measure of the impact of RA on participants that takes into account 7 domains: pain, functional disability, fatigue, physical and emotional well being, quality of sleep, and coping. The RAID is calculated based on 7 NRS questions. Range of the final RAID value is 0-10 where 0= not affected, very good and 10 = most affected weighted and calculated with a total score range of 0 (not affected, very good) to 10 (most affected). A higher RAID value indicates worse status and lower indicates not affected. LS mean and SE at Week 12 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline RAID scores as a covariate.|Baseline, Week 12|ITT population. Number of participants analyzed = number of participants with RAID score assessment at both baseline and Week 12.||units on a scale||Standard Error|Mean
669666|NCT01709578|Secondary|Change From Baseline in EQ-5D-3L VAS Scores at Week 12|The EQ-5D-3L is a standardized, generic measure of health outcome. EQ-5D was designed for self-completion by participants. The EQ-5D was specifically included to address concerns regarding the health economic impact of RA. The EQ-5D-3L comprises 5 questions on mobility, self-care, pain, usual activities, and psychological status with 3 possible answers for each item (1=no problem, 2=moderate problems, 3=severe problems) and a vertical VAS that allows the participants to indicate their health state today that can range from 0 (worst imaginable) to 100 (best imaginable). LS mean and SE at Week 12 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline EQ-5D-3L scores as a covariate.|Baseline, Week 12|ITT population. Number of participants analyzed = number of participants with EQ-5D-3L score assessment at both baseline and Week 12.||units on a scale||Standard Error|Least Squares Mean
669667|NCT01709578|Secondary|Change From Baseline in the FACIT-fatigue at Week 12|The FACIT-Fatigue is a 13-item questionnaire assessing fatigue where participants scored each item on a 5-point scale (0-4): 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much. A total score ranging from 0 to 52. A higher score corresponded to a lower level of fatigue. A positive change from baseline score indicates an improvement. LS mean and SE at Week 12 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline FACIT-fatigue as a covariate.|Baseline, Week 12|ITT population. Number of Participants analyzed = number of participants with FACIT-fatigue score assessment at both baseline and Week 12.||units on a scale||Standard Error|Least Squares Mean
669814|NCT01708902|Secondary|The Occurrence of Relative Efficacy Response in APG|The Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 12 Weeks of Treatment) in APG|From baseline until week 12|FAS (NCF)||percentage of participants||95% Confidence Interval|Number
669668|NCT01709578|Secondary|Change From Baseline in WPS-RA at Week 12: RA Interference With Household Work Productivity|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire was interviewer-administered and was based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). The RA interference in the last month with household work productivity was measured on a scale that ranges from 0 (no interference) to 10 (complete interference). LS mean and SE at Week 12 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline WPS-RA as a covariate.|Baseline, Week 12|ITT population. Number of participants analyzed = participants with WPS-RA individual items assessment at both baseline and Week 12.||units on a scale||Standard Error|Least Squares Mean
669669|NCT01709578|Secondary|Change From Baseline in WPS-RA at Week 12: Days With Outside Help Hired Due to RA|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire was interviewer-administered and was based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Number of days with outside help hired in the last month by the participant was reported. LS mean and SE at Week 12 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline WPS-RA as a covariate.|Baseline, Week 12|ITT population. Number of participants analyzed = participants with WPS-RA individual items assessment at both baseline and Week 12.||Days||Standard Error|Least Squares Mean
669670|NCT01709578|Secondary|Change From Baseline in WPS-RA at Week 12: Days With Family/Social/Leisure Activities Missed Due to RA|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire was interviewer-administered and was based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Number of days missed of family/social/leisure activities in the last month by the participant was reported. LS mean and SE at Week 12 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline WPS-RA as a covariate.|Baseline, Week 12|ITT population. Number of participants analyzed = participants with WPS-RA individual items assessment at both baseline and Week 12.||Days||Standard Error|Least Squares Mean
669671|NCT01709578|Secondary|Change From Baseline in WPS-RA at Week 12: Days With Household Work Productivity Reduced by ≥ 50% Due to RA|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire was interviewer-administered and was based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Number of days with reduced household work productivity by ≥ 50% in the last month by the participant was reported. LS mean and SE at Week 12 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline WPS-RA as a covariate.|Baseline, Week 12|ITT population. Number of participants analyzed = participants with WPS-RA individual items assessment at both baseline and Week 12.||Days||Standard Error|Least Squares Mean
669672|NCT01709578|Secondary|Change From Baseline in WPS-RA at Week 12: House Work Days Missed Due to RA|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire was interviewer-administered and was based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Number of days with no household work in the last month by the participant was reported. LS mean and SE at Week 12 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline WPS-RA as a covariate.|Baseline, Week 12|ITT population. Number of participants analyzed = participants with WPS-RA individual items assessment at both baseline and Week 12.||Days||Standard Error|Least Squares Mean
669673|NCT01709578|Secondary|Change From Baseline in WPS-RA at Week 12: RA Interference With Work Productivity|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire was interviewer-administered and was based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Interference in the last month with work productivity was measured on a scale that ranges from 0 (no interference) to 10 (complete interference). LS mean and SE at Week 12 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline WPS-RA as a covariate.|Baseline, Week 12|ITT population. Number of participants analyzed = participants with WPS-RA individual items assessment at both baseline and Week 12.||units on a scale||Standard Error|Least Squares Mean
669674|NCT01709578|Secondary|Change From Baseline in WPS-RA at Week 12: Days With Work Productivity Reduced by ≥ 50% Due to RA|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire was interviewer-administered and was based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Number of work days with reduced productivity by ≥ 50% in the last month by the participant was reported. LS mean and SE at Week 12 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline WPS-RA as a covariate.|Baseline, Week 12|ITT population. Number of participants analyzed = participants with WPS-RA individual items assessment at both baseline and Week 12.||Days||Standard Error|Least Squares Mean
669708|NCT01709513|Secondary|Percent Change From Baseline in Apo A-1 at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline Apo A-1 value on- or off-treatment.||percent change||Standard Error|Least Squares Mean
673919|NCT01656850|Primary|Body Fat Percentage at the Baseline and at the End of 3-month Dietary Intervention||at the baseline and at the end of 3-month dietary intervention|||percentage of body weight||Standard Deviation|Mean
669675|NCT01709578|Secondary|Change From Baseline in WPS-RA at Week 12: Work Days Missed Due to RA|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire was interviewer-administered and was based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Number of work days missed in the last month by the participant was reported. LS mean and SE at Week 12 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline WPS-RA as a covariate.|Baseline, Week 12|ITT population. Number of participants analyzed=participants with WPS-RA individual items assessment at both baseline and Week 12.||Days||Standard Error|Least Squares Mean
669676|NCT01709578|Secondary|Change From Baseline in SF-36 at Week 12|SF-36 is a generic 36-item questionnaire measuring HRQL covering 2 summary measures: PCS and MCS. The SF-36 consists of 8 subscales. The PCS is represented by 4 subscales: physical function, role limitations due to physical problems, pain, and general health perception. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; 0= worst HRQL, 100=best HRQL. Higher scores indicate better health and well-being. LS mean and SE at Week 12 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline SF-36 as a covariate.|Baseline, Week 12|ITT population. Number of participants analyzed=participants with SF-36 assessment at both baseline and Week 12.||units on a scale||Standard Error|Least Squares Mean
669677|NCT01709578|Secondary|Percentage of Participants Achieving Clinical Remission Score (DAS28-­CRP <2.6) at Week 12|DAS28 is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); GH by the participant assessed from the ACR RA core set questionnaire (participant global assessment) in 100 mm VAS; marker of inflammation assessed by hs-CRP in mg/L. The DAS28 provides a number indicating the current activity of the RA. DAS28 total score ranges from 2-10. A DAS28 score above 5.1 means high disease activity, whereas a DAS28 score below 3.2 indicates low disease activity and a DAS28 score below 2.6 means disease remission.|Week 12|ITT population.||Percentage of participants|||Number
669678|NCT01709578|Secondary|Change From Baseline in DAS28-CRP at Week 12|DAS28 is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); GH by the participant assessed from the ACR rheumatoid arthritis core set questionnaire (participant global assessment) in 100 mm VAS; marker of inflammation assessed by hs-CRP in mg/L. The DAS28 provides a number indicating the current activity of the RA. DAS28 total score ranges from 2-10. A DAS28 score above 5.1 means high disease activity, whereas a DAS28 score below 3.2 indicates low disease activity and a DAS28 score below 2.6 means disease remission. LS mean and SE at Week 12 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline DAS score as a covariate.|Baseline, Week 12|ITT population. Number of participants analyzed = number of participants with DAS28-CRP­ Score assessment at both baseline and Week 12.||units on a scale||Standard Error|Least Squares Mean
669679|NCT01709578|Secondary|Percentage of Participants Achieving ACR20, ACR50 and ACR70 Criteria at Week 12|ACR responses are assessed with a composite rating scale of the American College of Rheumatology that includes 7 variables: TJC; SJC; levels of an acute phase reactant (CRP level); participant's assessment of pain; participant's global assessment of disease activity; physician's global assessment of disease activity; participant's assessment of physical function by HAQ­-DI. ACR20 is defined as achieving at least 20% improvement in both TJC and SJC, and at least 20% improvement in at least 3 of the 5 other assessments of the ACR. ACR50 is defined as achieving at least 50% improvement in both TJC and SJC, and at least 50% improvement in at least 3 of the 5 other assessments of the ACR. ACR70 is defined as achieving at least 70% improvement in both TJC and SJC, and at least 70% improvement in at least 3 of the 5 other assessments of the ACR.|Week 12|ITT population.||Percentage of participants|||Number
669680|NCT01709578|Secondary|Change From Baseline in European Quality of Life-5 Dimension 3 Level (EQ-5D-3L) VAS Scores at Week 24|The EQ-5D-3L is a standardized, generic measure of health outcome. It was designed for self-completion by participants. It was specifically included to address concerns regarding the health economic impact of RA. The EQ-5D-3L comprises 5 questions on mobility, self-care, pain, usual activities, and psychological status with 3 possible answers for each item (1=no problem, 2=moderate problems, 3=severe problems) and a vertical VAS that allows the participants to indicate their health state today that can range from 0 (worst imaginable) to 100 (best imaginable). LS mean and SE at Week 24 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline EQ-5D-3L Scores as a covariate.|Baseline, Week 24|ITT population. Number of participants analyzed = number of participants with EQ-5D-3L score assessment at both baseline and Week 24.||units on a scale||Standard Error|Least Squares Mean
669681|NCT01709578|Secondary|Change From Baseline in Rheumatoid Arthritis Impact of Disease (RAID) Scores at Week 24|RAID is a composite measure of the impact of RA on participants that takes into account 7 domains: pain, functional disability, fatigue, physical and emotional well being, quality of sleep, and coping. The RAID is calculated based on 7 numerical rating scales (NRS) questions. Range of the final RAID value is 0-10 where 0= not affected, very good and 10 = most affected weighted and calculated with a total score range of 0 (not affected, very good) to 10 (most affected). A higher RAID value indicate worse status and lower indicate not affected. LS mean and SE at Week 24 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline RAID as a covariate.|Baseline, Week 24|ITT population. Number of participants analyzed = number of participants with RAID score assessment at both baseline and Week 24.||units on a scale||Standard Error|Least Squares Mean
669709|NCT01709513|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis|Combined Estimate for Adjusted Mean (Standard Error) at Week 24 from multiple imputation followed by robust regression including all available post-baseline data from Week 4 to Week 24 regardless of status on or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population||percent change||Standard Error|Mean
673920|NCT01656850|Primary|Body Weight at the Baseline and at the End of 3-month Dietary Intervention||at the baseline and at the end of 3-month dietary intervention|||kg||Standard Deviation|Mean
669682|NCT01709578|Secondary|Change From Baseline in WPS-RA at Week 24: RA Interference With Household Work Productivity|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire was interviewer-administered and was based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). The RA interference in the last month with household work productivity was measured on a scale that ranges from 0 (no interference) to 10 (complete interference). LS mean and SE at Week 24 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline WPS-RA as a covariate.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with WPS-RA individual items assessment at both baseline and Week 24.||units on a scale||Standard Error|Least Squares Mean
669683|NCT01709578|Secondary|Change From Baseline in WPS-RA at Week 24: Days With Outside Help Hired Due to RA|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire was interviewer-administered and was based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Number of days with outside help hired in the last month by the participant was reported. LS mean and SE at Week 24 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline WPS-RA as a covariate.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with WPS-RA individual items assessment at both baseline and Week 24.||Days||Standard Error|Least Squares Mean
669684|NCT01709578|Secondary|Change From Baseline in WPS-RA at Week 24: Days With Family/Social/Leisure Activities Missed Due to RA|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire was interviewer-administered and was based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Number of days missed of family/social/leisure activities in the last month by the participant was reported. LS mean and SE at Week 24 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline WPS-RA as a covariate.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with WPS-RA individual items assessment at both baseline and Week 24.||Days||Standard Error|Least Squares Mean
669685|NCT01709578|Secondary|Change From Baseline in WPS-RA at Week 24: Days With Household Work Productivity Reduced by ≥ 50% Due to RA|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire was interviewer-administered and was based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Number of days with reduced household work productivity by ≥ 50% in the last month by the participant was reported. LS mean and SE at Week 24 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline WPS-RA as a covariate.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with WPS-RA individual items assessment at both baseline and Week 24.||Days||Standard Error|Least Squares Mean
669686|NCT01709578|Secondary|Change From Baseline in WPS-RA at Week 24: House Work Days Missed Due to RA|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire was interviewer-administered and was based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Number of days with no household work in the last month by the participant was reported. LS mean and SE at Week 24 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline WPS-RA as a covariate.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with WPS-RA individual items assessment at both baseline and Week 24.||Days||Standard Error|Least Squares Mean
669687|NCT01709578|Secondary|Change From Baseline in WPS-RA at Week 24: RA Interference With Work Productivity|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire was interviewer-administered and was based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Interference in the last month with work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference). LS mean and SE at Week 24 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline WPS-RA as a covariate.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with WPS-RA individual items assessment at both baseline and Week 24.||units on a scale||Standard Error|Least Squares Mean
669688|NCT01709578|Secondary|Change From Baseline in WPS-RA at Week 24: Days With Work Productivity Reduced by ≥ 50% Due to RA|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire was interviewer-administered and was based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Number of work days with reduced productivity by ≥ 50% in the last month by the participant was reported. LS mean and SE at Week 24 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline WPS-RA as a covariate.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with WPS-RA individual items assessment at both baseline and Week 24.||Days||Standard Error|Least Squares Mean
669710|NCT01709513|Secondary|Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline HDL-C value on- or off-treatment.||percent change||Standard Error|Least Squares Mean
673921|NCT01656850|Primary|Lipid Composition of NCEP Step 2 Diet and Almond Diets||the entire study, up to 3 months|||g||Standard Deviation|Mean
669689|NCT01709578|Secondary|Change From Baseline in Work Productivity Survey - Rheumatoid Arthritis (WPS-RA) at Week 24: Work Days Missed Due to RA|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire was interviewer-administered and was based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Number of work days missed in the last month by the participant was reported. LS mean and SE at Week 24 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline WPS-RA as a covariate.|Baseline, Week 24|ITT population. Number of participants analyzed=participants with WPS-RA individual items assessment at both baseline and Week 24.||Days||Standard Error|Least Squares Mean
669690|NCT01709578|Secondary|Change From Baseline in Morning Stiffness VAS at Week 24|RA is associated with stiffness of joints, especially in the morning after prolonged stationery state. The degree of stiffness can be an indicator of disease severity. The severity of morning stiffness was assessed on a VAS scale from 0 mm (no problem) to 100 mm (major problem). LS mean and SE at Week 24 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline Morning Stiffness as a covariate.|Baseline, Week 24|ITT population. Number of participants analyzed = number of participants with morning stiffness VAS assessment at both baseline and Week 24.||mm||Standard Error|Least Squares Mean
669691|NCT01709578|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-fatigue) Score at Week 24|The FACIT-Fatigue is a 13-item questionnaire assessing fatigue where participants scored each item on a 5-point scale (0-4): 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much. A total score ranging from 0 to 52. A higher score corresponded to a lower level of fatigue. A positive change from baseline score indicates an improvement. LS mean and SE at Week 24 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline FACIT-fatigue as a covariate.|Baseline, Week 24|ITT population. Number of Participants analyzed = number of participants with FACIT-fatigue score assessment at both baseline and Week 24.||units on a scale||Standard Error|Least Squares Mean
669692|NCT01709578|Secondary|Change From Baseline in SF-36 MCS at Week 24|SF-36 is a generic 36-item questionnaire measuring HRQL covering 2 summary measures: PCS and MCS. The SF-36 consists of 8 subscales. The PCS is represented by 4 subscales: physical function, role limitations due to physical problems, pain, and general health perception. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; 0= worst HRQL, 100=best HRQL. Higher scores indicate better health and well-being. LS mean and SE at Week 24 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline SF-36 MCS as a covariate.|Baseline, Week 24|ITT population. Number of participants analyzed=participants with SF-36 MCS assessment at both baseline and Week 24.||units on a scale||Standard Error|Least Squares Mean
669693|NCT01709578|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Physical Component Summary Scores (PCS) at Week 24|SF-36 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: PCS and mental component summary (MCS). The SF-36 consists of 8 subscales. The PCS had 4 subscales: physical function, role limitations due to physical problems, pain, and general health perception. The MCS had 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; 0= worst HRQL, 100=best HRQL. Higher scores indicate better health and well-being. LS mean and SE at Week 24 by MMRM with treatment,region,number of previous anti TNFs,visit,and treatment-by-visit interaction as fixed effects and baseline SF-36 (PCS) as a covariate.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with SF-36 PCS assessment at both baseline and Week 24.||units on a scale||Standard Error|Least Squares Mean
669694|NCT01709578|Secondary|Change From Baseline in HAQ-DI at Week 24|Physical function was assessed by HAQ-DI. It consisted of at least 2 questions per category, participant reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week rated on a 4-point scale where 0 = no difficulty; 1 = some difficulty; 2 = much difficulty; 3 = unable to do. Overall score was computed as the sum of category scores and divided by the number of categories answered, ranging from 0 to 3, where 0 = no disability and 3 = unable to do, high-dependency disability. LS means and SE at Week 24 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline HAQ-DI as a covariate.|Baseline, Week 24|ITT population. Number of participants analyzed = number of participants with HAQ-DI assessment at both baseline and Week 24.||units on a scale||Standard Error|Least Squares Mean
669695|NCT01709578|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 24|CDAI is a composite index constructed to measure clinical remission in RA that does not include a laboratory test, and is a numerical summation of 4 components: TJC (28 joints), SJC (28 joints), Participant's Global Assessment of Disease Activity VAS (in cm), and Physician's Global Assessment of Disease VAS (in cm). Total scores ranges from 0 to 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity. LS means and SE at Week 24 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline CDAI as a covariate.|Baseline, Week 24|ITT population. Number of participants analyzed=number of participants with CDAI assessment at both baseline and Week 24.||units on a scale||Standard Error|Least Squares Mean
669711|NCT01709513|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 24 - ITT Analysis|Combined Estimate for Adjusted Mean (Standard Error) at Week 24 from multiple imputation followed by robust regression including all available post-baseline data from Week 4 to Week 24 regardless of status on or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population.||percent change||Standard Error|Mean
669696|NCT01709578|Secondary|Percentage of Participants Achieving Clinical Remission Score (DAS28-CRP) <2.6 at Week 24|DAS28 is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); GH by the participant assessed from the ACR rheumatoid arthritis core set questionnaire (participant global assessment) in 100 mm VAS; marker of inflammation assessed by hs-CRP in mg/L. The DAS28 provides a number indicating the current activity of the RA. DAS28 total score ranges from 2-10. A DAS28 score above 5.1 means high disease activity, whereas a DAS28 score below 3.2 indicates low disease activity and a DAS28 score below 2.6 means disease remission.|Week 24|ITT population.||Percentage of participants|||Number
669697|NCT01709578|Secondary|Percentage of Participants Achieving ACR70 Criteria at Week 24|ACR responses are assessed with a composite rating scale of the American College of Rheumatology that includes 7 variables: TJC; SJC; levels of an acute phase reactant (CRP level); participant's assessment of pain; participant's global assessment of disease activity; physician's global assessment of disease activity; participant's assessment of physical function by HAQ-­DI. ACR70 is defined as achieving at least 70% improvement in both TJC and SJC, and at least 70% improvement in at least 3 of the 5 other assessments of the ACR.|Week 24|ITT population.||Percentage of participants|||Number
669698|NCT01709578|Secondary|Percentage of Participants Achieving ACR50 Criteria at Week 24|ACR responses are assessed with a composite rating scale that includes 7 variables: TJC; SJC; levels of an acute phase reactant (CRP level); participant's assessment of pain; participant's global assessment of disease activity; physician's global assessment of disease activity; participant's assessment of physical function by HAQ-­DI. ACR50 is defined as achieving at least 50% improvement in both TJC and SJC, and at least 50% improvement in at least 3 of the 5 other assessments of the ACR.|Week 24|ITT population.||Percentage of participants|||Number
669699|NCT01709578|Secondary|Change From Baseline in Disease Activity Score for 28 Joints ­C-Reactive Protein (DAS28-­CRP) Score at Week 24|DAS28 is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); General health (GH) assessment by the participant assessed from the ACR rheumatoid arthritis (RA) core set questionnaire (participant global assessment) in 100 mm visual analog scale (VAS). Marker of inflammation assessed by the high sensitivity C-reactive protein (hs-CRP) in mg/L. The DAS28 score provides a number indicating the current disease activity of the RA. DAS28 total score ranges from 2-10. A DAS28 score above 5.1 means high disease activity, whereas a DAS28 score below 3.2 indicates low disease activity and a DAS28 score below 2.6 means disease remission. LS means and SE at Week 24 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline DAS28-CRP score as a covariate.|Baseline, Week 24|ITT population. Number of participants analyzed = number of participants with DAS28-­CRP Score assessment at both baseline and Week 24.||units on a scale||Standard Error|Least Squares Mean
669700|NCT01709578|Primary|Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 12|Physical function was assessed by HAQ-DI. It consisted of at least 2 questions per category, participant reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week rated on a 4-point scale where 0 = no difficulty; 1 = some difficulty; 2 = much difficulty; 3 = unable to do. Overall score was computed as the sum of category scores and divided by the number of categories answered, ranging from 0 to 3, where 0 = no disability and 3 = unable to do, high-dependency disability. Least-squares (LS) means and standard errors (SE) at Week 12 were obtained from a mixed-effect model with repeated measures (MMRM) with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline HAQ-DI as a covariate.|Baseline, Week 12|ITT population. Number of participants analyzed = number of participants with HAQ-DI assessment at both baseline and Week 12.||units on a scale||Standard Error|Least Squares Mean
669701|NCT01709578|Primary|Percentage of Participants Who Achieved at Least 20% Improvement in the American College of Rheumatology (ACR20) Criteria at Week 24|ACR responses are assessed with a composite rating scale of the American College of Rheumatology that includes 7 variables: tender joint count (TJC); swollen joint count (SJC); levels of an acute phase reactant (C-reactive Protein levels [CRP]); participant's assessment of pain; participant's global assessment of disease activity; physician's global assessment of disease activity; participant's assessment of physical function by (health assessment questionnaire disability index [HAQ-DI]). ACR20 is defined as achieving at least 20% improvement in both TJC and SJC, and at least 20% improvement in at least 3 of the 5 other assessments of the ACR.|Week 24|Intent-to-treat (ITT) population included all randomized participants.||percentage of participants|||Number
669702|NCT01709513|Other Pre-specified|Percent Change From Baseline in Calculated LDL-C at Week 24 Versus Atorvastatin - Raw Data Description - Intent-To-Treat (ITT) Analysis||From Baseline up to Week 24|ITT population||percent change||Standard Deviation|Mean
669703|NCT01709513|Other Pre-specified|Percentage of Participants Who Experienced Skeletal Muscle-related Adverse Event (AE)|Skeletal muscle-related adverse events were a predefined category including myalgia, muscle spasms, muscular weakness, musculoskeletal stiffness and muscle fatigue. Events that developed during treatment emergent adverse events period (the time from the first double-blindstudy treatment [injection or capsules, whichever came first] up to the day of the last double-blind injection + 70 days ) are reported.|From Baseline up to Week 24|Safety population||participants|||Number
669704|NCT01709513|Secondary|Percent Change From Baseline in Apo A­-1 at Week 12 -­ ITT Analysis|Least squares (LS) means and standard errors (SE) taken from MMRM (mixed effect model with repeated measures) analysis.|From Baseline to Week 12|Apo A-1 ITT population.||percent change||Standard Error|Least Squares Mean
669705|NCT01709513|Secondary|Percent Change in Fasting Triglycerides From Baseline to Week 12 -­ ITT Analysis|Combined Estimate for Adjusted Mean (Standard Error) at Week 24 from multiple imputation followed by robust regression including all available post-baseline data from Week 4 to Week 24 regardless of status on or off-treatment.|From Baseline to Week 12|Fasting Triglycerides ITT population.||percent change||Standard Error|Mean
669706|NCT01709513|Secondary|Percent Change in HDL-C From Baseline to Week 12 -­ ITT Analysis|Least-squares (LS) means and standard errors (SE) taken from MMRM (mixed-effect model with repeated measures) analysis|From Baseline to Week 12|HDL-C ITT population.||percent change||Standard Error|Least Squares Mean
669815|NCT01708902|Secondary|The Occurrence of Relative Efficacy Response in Main Group|The occurrence of relative efficacy response (HbA1c lowering by at least 0.5% after 24 weeks of treatment) in main group|From baseline until week 24|FAS (NCF)||percentage of participants||95% Confidence Interval|Number
669712|NCT01709513|Secondary|Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis|Adjusted percentages at Week 24 were obtained from a multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 24 i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first (on-treatment analysis).|Up to Week 24|mITT population.||percentage of participants|||Number
669713|NCT01709513|Secondary|Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis|Adjusted percentages at Week 24 were obtained from a multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment were included in the imputation model (ITT analysis).|Up to Week 24|ITT population.||percentage of participants|||Number
669714|NCT01709513|Secondary|Percentage of Very High CV Risk Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) or Moderate or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - On-Treatment Analysis|Adjusted percentages at Week 24 were obtained from a multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 24 i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first (on-treatment analysis).|Up to Week 24|mITT population.||percentage of participants|||Number
669715|NCT01709513|Secondary|Percentage of Very High CV Risk Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) or Moderate or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - ITT Analysis|Adjusted percentages at Week 24 were obtained from a multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment were included in the imputation model (ITT analysis).|Up to Week 24|ITT population.||percentage of participants|||Number
669716|NCT01709513|Secondary|Percent Change From Baseline in Total-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|From Baseline to Week 12|Total-C ITT population.||percent change||Standard Error|Least Squares Mean
669717|NCT01709513|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|From Baseline to Week 12|Non-HDL-C ITT population.||percent change||Standard Error|Least Squares Mean
669718|NCT01709513|Secondary|Percent Change From Baseline in Apo B at Week 12 -­ ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|From Baseline to Week 12|Apo B ITT population.||percent change||Standard Error|Least Squares Mean
669719|NCT01709513|Secondary|Percent Change From Baseline in Total Cholesterol (Total­-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline total-C value on- or off-treatment.||percent change||Standard Error|Least Squares Mean
669720|NCT01709513|Secondary|Percent Change From Baseline in Non­-HDL-C at Week 24 ­- On­-Treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first).|From Baseline to Week 24|Participants analyzed: participants of the mITT population with one baseline and at least one post-baseline Non-HDL-C value on-treatment.||percent change||Standard Error|Least Squares Mean
669721|NCT01709513|Secondary|Percent Change From Baseline in Non­-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 ­- ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment.||percent change||Standard Error|Least Squares Mean
669722|NCT01709513|Secondary|Percent Change From Baseline in Apo B at Week 24 -­ On-­Treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first).|From Baseline to Week 24|Participants analyzed: participants of the mITT population with one baseline and at least one post-baseline Apo B value on-treatment.||percent change||Standard Error|Least Squares Mean
669723|NCT01709513|Secondary|Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 ­- ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-­baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline Apo B value on- or off-treatment.||percent change||Standard Error|Least Squares Mean
669724|NCT01709513|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - On­-Treatment Analysis|Calculated LDL-C values were obtained from Friedewald formula. Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first) (on-treatment analysis).|From Baseline to Week 12|mITT population.||percent change||Standard Error|Least Squares Mean
669725|NCT01709513|Secondary|Percent Change From Baseline in Calculated LDL­-C at Week 12 -­ ITT Analysis|Calculated LDL-C values were obtained from Friedewald formula. Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|From Baseline to Week 12|ITT population.||percent change||Standard Error|Least Squares Mean
669742|NCT01709500|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on­ or off-treatment.|From Baseline to Week 52|Non-HDL-C ITT population.||percent change||Standard Error|Least Squares Mean
673922|NCT01656850|Primary|The Calories of NCEP Step 2 Diet and Almond Diets||the entire study, up to 3 months|||kcal||Standard Deviation|Mean
669726|NCT01709513|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 24 - On-­Treatment Analysis|Calculated LDL-C values were obtained from Friedewald formula. Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first) (on-treatment analysis).|From Baseline to Week 24|Modified ITT (mITT) population: all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.||percent change||Standard Error|Least Squares Mean
669727|NCT01709513|Primary|Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-­To-Treat (ITT) Analysis|Calculated LDL-C values were obtained from Friedewald formula. Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment were used in the model (ITT analysis).|From Baseline to Week 24|ITT population: all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on­ or off-treatment.||percent change||Standard Error|Least Squares Mean
669728|NCT01709500|Secondary|Percent Change From Baseline in Apo A­1 at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|Apo A-1 ITT population.||percent change||Standard Error|Least Squares Mean
669729|NCT01709500|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|Fasting triglycerides ITT population.||percent change||Standard Error|Mean
669730|NCT01709500|Secondary|Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|HDL-C ITT population.||percent change||Standard Error|Least Squares Mean
669731|NCT01709500|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|Lipoprotein (a) ITT population.||percent change||Standard Deviation|Mean
669732|NCT01709500|Secondary|Percent Change From Baseline in Apo A-1 at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline Apo A-1 value on- or off-treatment.||percent change||Standard Error|Least Squares Mean
669733|NCT01709500|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|Participants analyzed: participants of the ITT population.||percent change||Standard Error|Mean
669734|NCT01709500|Secondary|Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline HDL-C value on- or off-treatment.||percent change||Standard Error|Least Squares Mean
669735|NCT01709500|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|Participants analyzed: participants of the ITT population.||percent change||Standard Error|Mean
669736|NCT01709500|Secondary|Percentage of Participants Reaching Calculated LDL­-C <70 mg/dL (1.81 mmol/L) at Week 52 - On-Treatment Analysis|Adjusted percentages at Week 52 were obtained from a multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 52 i.e. up to 21 days after last injection (on-treatment analysis).|Up to Week 52|mITT population.||percentage of participants|||Number
669737|NCT01709500|Secondary|Percentage of Participants Reaching Calculated LDL­C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis|Adjusted percentages at Week 24 were obtained from a multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were included in the imputation model (ITT analysis).|Up to Week 52|ITT population.||percentage of participants|||Number
669738|NCT01709500|Secondary|Percentage of Very High CV Risk Participants Reaching Calculated LDL­-C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL­-C <100 mg/dL (2.59 mmol/L) at Week 24 - On-Treatment Analysis|Adjusted percentages at Week 24 were obtained from a multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 52 i.e. up to 21 days after last injection (on-treatment analysis).|Up to week 52|mITT population.||percentage of participants|||Number
669739|NCT01709500|Secondary|Percentage of Very High CV Risk Participants Reaching Calculated LDL­C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL­C <100 mg/dL (2.59 mmol/L) at Week 24 - ITT Analysis|Adjusted percentages at Week 24 were obtained from a multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on­ or off-treatment were included in the imputation model (ITT analysis).|Up to Week 52|ITT population.||percentage of participants|||Number
669740|NCT01709500|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 52 - ITT Analysis|Calculated LDL-C values were obtained using the Friedewald formula. Adjusted LS means and standard errors at Week 52 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on­ or off treatment (ITT analysis).|From Baseline to Week 52|ITT population.||percent change||Standard Error|Least Squares Mean
669741|NCT01709500|Secondary|Percent Change From Baseline in Total-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post baseline data from Week 4 to Week 52 regardless of status on- or off treatment.|From Baseline to Week 52|Total-­C ITT population.||percent change||Standard Error|Least Squares Mean
669744|NCT01709500|Secondary|Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on­ or off-treatment.|From Baseline to Week 52|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline total-C value on- or off-treatment.||percent change||Standard Error|Least Squares Mean
669745|NCT01709500|Secondary|Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|From Baseline to Week 52|mITT population||percent change||Standard Error|Least Squares Mean
669746|NCT01709500|Secondary|Percent Change From Baseline in Non-High ­Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on­ or off-treatment.|From Baseline to Week 52|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment.||percent change||Standard Error|Least Squares Mean
669747|NCT01709500|Secondary|Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on­treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|From Baseline to Week 52|mITT population||percent change||Standard Error|Least Squares Mean
669748|NCT01709500|Secondary|Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline Apo B value on- or off-treatment.||percent change||Standard Error|Least Squares Mean
669749|NCT01709500|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - On- Treatment Analysis|Calculated LDL-C values were obtained using the Friedewald formula. Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection) (on-treatment analysis).|From Baseline to Week 52|mITT population.||percent change||Standard Error|Least Squares Mean
669750|NCT01709500|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment (ITT analysis).|From Baseline to Week 52|ITT population.||percent change||Standard Error|Least Squares Mean
669751|NCT01709500|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis|Calculated LDL-C values were obtained using the Friedewald formula. Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection) (on-treatment analysis).|From Baseline to Week 52|Modified ITT (mITT) population: all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.||percent change||Standard Error|Least Squares Mean
669752|NCT01709500|Primary|Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent­-to­-Treat (ITT) Analysis|Calculated LDL-C values were obtained using the Friedewald formula. Adjusted Least­ squares (LS) means and standard errors at Week 24 were obtained from a mixed ­effect model with repeated measures (MMRM) to account for missing data. All available post ­baseline data from Week 4 to Week 52 regardless of status on­ or off-treatment were used in the model.|From Baseline to Week 52|ITT population: all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment.||percent change||Standard Error|Least Squares Mean
669753|NCT01709474|Primary|Percentage of Subjects by Treatment Arm Experiencing Any Adverse Event (AE) ≥ Grade 3|Adverse event grading based on National Cancer Institute— Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.0|Baseline to 18 Weeks|Intent-to-treat||Percentage of Participants|||Number
669754|NCT01709474|Primary|Change in Average IFN Module Expression Level|No mechanistic analyses were performed due to recruitment feasibility issues.|Baseline to Week 18|Data were not collected and therefore no analyses could be performed.|||||
669755|NCT01709422|Primary|Procedure Related Time|(1) induction time ( the time from sedation to scope intubation ), (2) procedure time ( the time from scope intubation to scope withdrawal ) and (3) recovery time ( the time from scope withdrawal to full recovery ).The induction time, procedural time and recovery time were recorded by the nurse in the endoscopy unit.|participants will be followed for the duration of procedure, an expected average of 2.0 hours ]|Intention to treat population include participants who received sedative agents and underwent endoscopic retrograde cholangiopancreatography(ERCP).||minutes||Standard Deviation|Mean
669756|NCT01709422|Secondary|Cardiovascular Adverse Events.|(1) desaturation(oxygen saturation < 90 % at least 10 second ) (2) hypotension ( systolic blood pressure < 90 mmHg or dropped more than 25 % of baseline ) (3)bradycardia (heart rate < 50 beats/min) and (4) apnea ( cessation of respiratory activity for over 10 seconds ). When patients developed oxygen saturation < 90 %, then nasal oxygen was administered, If patients not able to recover from oxygen therapy and tactile stimulations thus the procedure was terminated. The procedure was terminated if patients developed serious adverse event as heart rate below 5 beats/min and or apnea.|participants will be followed for the duration of procedure, an expected average of 2.0 hours|Intention to treat population include participants who received sedative agents and underwent ERCP.||Participants|||Number
669757|NCT01709383|Secondary|Motricity Index|An assessment of upper extremity motor impairment, including: pinch grip, elbow flexion, and shoulder abduction. For pinch grip, which consisted of holding a small plastic cube between the thumb and index finger, scoring was as follows: 0=No movement, 11=Beginnings of prehension, 19=Grips cube but unable to hold against gravity, 22=Grips cube, held against gravity but not against weak pull, 26=Grips cube against pull but weaker than left side, 33=Normal pinch grip. For elbow flexion and shoulder abduction, scoring was as follows: 0=No movement, 9=Palpable contraction in muscle but no movement, 14=Movement seen but not full range/not against gravity, 19=Full range against gravity, not against resistance, 25=Movement against resistance but weaker than left side, 33=Normal power. Both the right and the left side were tested.|Change from baseline to 1 day after treatment|People with aphasia due to left hemisphere stroke||scores on a scale||Standard Deviation|Mean
669758|NCT01709383|Secondary|Reading Assessments|A set of reading tasks designed to assess oral reading of real words and non-words at the single word level. The list of real words consisted of 142 words. A score of 0 indicates no words were read correctly and a score of 142 indicates all words were read correctly. The non-word test included 30 non-words. A score of 0 indicates no non-words were read correctly and a score of 30 indicates that all non-words were read correctly.|Change from baseline to 1 day after treatment|People with aphasia due to left hemisphere stroke||scores on a scale||Standard Deviation|Mean
669759|NCT01709383|Secondary|Cognitive-Linguistic Quick Test (CLQT)|The following subtests from the CLQT will be administered: Symbol Cancellation, Story Retelling, Generative Naming, Symbol Trails, Design Memory, Mazes,and Design Generation. These scores will be used to calculate composite scores for the cognitive domains of Attention, Executive Function (EF), and Visuospatial skills (VS). Some tests are weighted more than others in each composite score, by multiplying the score as follows and then adding the scores together: Attention = Symbol Cancellation (x9), Story Retelling (x2), Symbol Trails (x3), Mazes (x4), and Design Generation (x1); EF = sum of Symbol Trails, Generative Naming, Mazes, and Design Generation; VS = Symbol Cancellation (x2), Symbol Trails (x2), Design Memory (x4), Mazes (x3), Design Generation (x1). For all composite scores, a low number indicates greater deficit. For Attention, the highest score is 215 and lowest is 0. For EF, the highest score is 40 and lowest is 0. For VS, the highest score is 105 and lowest is 0|Change from baseline to 1 day after treatment|People with aphasia due to left hemisphere stroke||scores on a scale||Standard Deviation|Mean
669760|NCT01709383|Secondary|Subjective Assessments Including: Communicative Effectiveness Index (CETI), Stroke and Aphasia Quality of Life Scale (SAQOL), and Stroke Aphasic Depression Questionnaire (SADQ)|"Questionnaires were given at baseline, 3 weeks and 3 months after treatment. The SADQ consists of 21 questions graded on a 0-3 scale with 3 indicating the highest depression symptoms and 0 indicating none. Therefore, means reported below are an average score between 0 and 3. The SAQOL includes 17 questions about functional physical limitations and 7 questions about functional communication limitations in daily life. Questions are rated on a 1-5 scale with a score of 1 indicating greater disability and 5 indicating none. Therefore, means reported below are an average score between 1 and 5. The CETI measures change in functional communication by asking caregivers to make a mark on a straight line with as able as before the stroke written on the right side of the line and not at all as able on the left. The 16 responses are then converted by measuring the location of the mark on the line. A score of 10 indicates as able as before the stroke and 0 indicates not at all as able."|3 weeks post-treatment|People with aphasia due to left hemisphere stroke||scores on a scale||Standard Deviation|Mean
669761|NCT01709383|Secondary|Philadelphia Naming Test (PNT)|A test of picture naming using more common items than other picture naming tests, which reduces relationships between performance and premorbid education and socioeconomic status. There are 60 items on the test. A score of 0 means no pictures were named correctly. A score of 60 means all pictures were named correctly.|1 day after treatment|People with aphasia due to left hemisphere stroke||scores on a scale||Standard Deviation|Mean
669762|NCT01709383|Secondary|Western Aphasia Battery - Revised: Spontaneous Speech, Repetition, Auditory Verbal Comprehension and Overall Aphasia Quotient|The above subtests will reflect the following: a composite measure of information content in conversational speech and picture description (scored from 0 (no speech produced or only meaningless utterances) to 10 (no signs of aphasia)); a measure of word and sentence repetition (scored from 0 (unable to repeat any part of a single word) to 100 (perfect repetition of all words and up to a 10 word sentence)); a composite measure of yes/no questions, auditory word recognition, and following sequential commands (composite subscore is from 1 to 10, with 10 being the best outcome); and an overall aphasia severity score (composite score, or Aphasia Quotient, comprised of all the above measures plus the naming and word finding score used as the primary outcome measure. Quotient scores range from 0 to 100, with 100 indicating no aphasia is present).|Change from baseline to 1 day after treatment|People with aphasia due to left hemisphere stroke||scores on a scale||Standard Deviation|Mean
669763|NCT01709383|Primary|Western Aphasia Battery - Revised: Naming and Word Finding Score|This is a composite measure of verbal expression skills including tests of naming, verbal fluency, sentence completion, and responsive naming (one-word answers to basic questions). It is a subtest within the Western Aphasia Battery. The minimum score is 0 and maximum is 10, with 10 being the best outcome, and subscores are summed to determine the total score.|Change from baseline to one day after treatment|People with aphasia due to left hemisphere stroke||scores on a scale||Standard Deviation|Mean
669764|NCT01709331|Secondary|Percentage of Participants With Induced Spermatogenesis Resulting in a Sperm Count ≥1x10^6/mL at or Before Week 52|Semen samples were produced by masturbation after at least 48 hours of sexual abstinence and collected for evaluation in the pretreatment phase at Week -1, and during the combined treatment phase at Weeks 16, 28, 40, and 52.|Up to Week 52|FAS population, which consisted of all participants who received any dose of corifollitropin alfa and who had a baseline and at least one post-baseline measurement of testicular volume.||Percentage of participants||95% Confidence Interval|Number
669765|NCT01709331|Primary|Percentage of Participants With Anti-Corifollitropin Alfa Antibodies|Blood samples were collected for assessment of anti-corifollitropin alfa antibodies in the pretreatment phase at Week -16 and Week -1; during the combined treatment phase at Weeks 4, 16, 28, 50, 52; and at the post-treatment follow-up visit, which could occur from Week 53 up to Week 57.|Up to Week 57|All-Subjects-as-Treated (ASaT) population, which consisted of all participants who received any dose of corifollitropin alfa.||Percentage of participants|||Number
669766|NCT01709331|Primary|Change From Baseline in Log-Transformed Testicular Volume at Week 52|Participants underwent testicular ultrasound in the pretreatment phase at Weeks -16, -8, -1; and during the combined treatment phase at Baseline (predose, Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52. The testicular volume was measured as the sum of volumes of left and right testes. The mean change from Day 1 in log-transformed testicular volume was analyzed using a mixed model with a fixed effect for time point and a random effect for the participant. For each time point, the mean change from Day 1 to that time point and the associated 95% confidence interval (CI) was calculated. The geometric mean fold change in testicular volume and its 95% CI was obtained by exponentiation.|Baseline and Week 52|Full Analysis Set (FAS) population, which consisted of all participants who received any dose of corifollitropin alfa and who had a baseline and at least one post-baseline measurement of testicular volume.||Fold change||95% Confidence Interval|Geometric Mean
669768|NCT01709305|Secondary|Percentage of Participants With a GI AE of Diarrhea (Phase 2)|"The percentage of participants with a GI AE of diarrhea was reported."|From Week 20 through Week 44|All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment and were compliant with GCP requirements.||Percentage of Participants|||Number
669769|NCT01709305|Secondary|Percentage of Participants With a GI AE of Vomiting (Phase 2)|"The percentage of participants with a GI AE of vomiting was reported."|From Week 20 through Week 44|All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment and were compliant with GCP requirements.||Percentage of Participants|||Number
669770|NCT01709305|Secondary|Percentage of Participants With a Gastrointestinal (GI) AE of Nausea (Phase 2)|"The percentage of participants with a GI AE of nausea was reported."|From Week 20 through Week 44|All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment and were compliant with GCP requirements.||Percentage of Participants|||Number
669771|NCT01709305|Secondary|Percentage of Participants With Hypoglycemia Events (Phase 2)|Hypoglycemia events represent epidsodes symptomatic of hypoglycemia (e.g., weakness, dizziness, shakiness, increased sweating, palpitations, or confusion) and/or finger stick glucose values of ≤70 mg/dL (3.9 mmol/L). The percentage of participants with hypoglycemia events was reported.|From Week 20 through Week 44|All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment and were compliant with GCP requirements.||Percentage of Participants|||Number
669772|NCT01709305|Secondary|Change From Phase 2 Baseline to Week 44 in Participant Body Weight (Phase 2)|Change from baseline in body weight in Phase 2 was reported. Change from baseline reflects the Week 44 body weight minus baseline body weight. Baseline is defined as Visit 6/Week 20. If this measurement was unavailable, the Week 16 value was used.|Phase 2 Baseline (Week 20), Week 44|All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment and were compliant with GCP requirements.||kg||Standard Deviation|Mean
669773|NCT01709305|Primary|Change From Phase 2 Baseline to Week 44 in Hemoglobin A1c (HbA1c) Levels (Phase 2)|HbA1c is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Change from baseline reflects the Week 44 A1C minus baseline A1C. Baseline is defined as Visit 6/Week 20. If this measurement was unavailable, the Week 16 value was used. Change from baseline was based on the constrained longitudinal data analysis (cLDA) model including all available measurements from baseline through the last visit. The terms in the cLDA model include treatment, time in weeks (categorical), regions, and treatment-by-time interaction.|Phase 2 Baseline (Week 20) and Week 44|Per-Protocol (PP) population - excluded those participants who were identified as protocol violators and those who were non-compliant with Good Clinical Practice (GCP) requirements.||Percent||95% Confidence Interval|Least Squares Mean
669774|NCT01709227|Secondary|Modified Oxygenation Index|Product of Mean airway pressure delivered by mechanical ventilation and FiO2 of administered oxygen|at 24 and 48 hours postoperative|||Units||Inter-Quartile Range|Median
669775|NCT01709227|Secondary|B-Natriuretic Peptide|BNP measured at 24 and 48 hours postoperatively|At 24hours and 48 hours postoperative|||pg/ml||Inter-Quartile Range|Mean
669776|NCT01709227|Secondary|Doses of Potassium Chloride or Arginine Chloride Required|Total doses of potassium chloride or arginine chloride given during the first five postoperative days.|Postop day 0-5|||doses given||Inter-Quartile Range|Median
669777|NCT01709227|Secondary|Renal/Electrolyte Abnormalities|Total sum of renal and electrolyte abnormalities over the first 5 postoperative days as defined in the protocol|Postop morning 1-5|||abnormalities||Inter-Quartile Range|Median
669778|NCT01709227|Secondary|All Cause Mortality|In-hospital mortality|duration of hospitalization (an average of 2 weeks)|||Participants|||Count of Participants
669779|NCT01709227|Secondary|Duration of Hospital Stay|Total days of initial postoperative stay in hospital|Average 4 weeks|||days||Inter-Quartile Range|Median
669780|NCT01709227|Secondary|Duration of Cardiac ICU Stay|Total days of initial postoperative stay in cardiac ICU|Average 2 weeks|||days||Inter-Quartile Range|Median
669781|NCT01709227|Secondary|NGAL Concentration||Pre-op, and postop (2hr, 6hr, 12hr, 24hr, 48hr)|Data were collected but not analyzed. Due to a high incidence of volatile and un-reportable NGAL levels, concerns were raised about the storage or processing of samples affecting data validity. Given the overwhelming concern of erroneous data, analysis was not performed as planned.|||||
669782|NCT01709227|Secondary|Respiratory Support Administered|Duration of initial course of postoperative mechanical ventilation|Duration of postoperative intubation (average time approximately- 1 week)|||days||Inter-Quartile Range|Median
669783|NCT01709227|Primary|Number of Participants With Negative Fluid Balance on Postop Day 1|Difference of inputs and outputs, including urine output and PD drainage.|Postop day 1|||Participants|||Count of Participants
669784|NCT01709162|Other Pre-specified|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs (irAEs)|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|From Day 1 of treatment to 90 days after last dose (or to death date for death information)|All participants who received at least 1 dose of study drug||Participants|||Number
669785|NCT01709162|Secondary|Best Overall Response Rate (BORR)|BORR is defined per arm as the total number of randomized patients with a best overall response of complete response or partial response, divided by the total number of randomized patients in the arm. Bristol-Myers Squibb terminated this study early because the study would not meet its scientific objective in the predefined timeframe. Because the study ended before best overall response for all patients was defined, no participant data was analyzed.|Every 3 months for approximately 3.5 years after start of randomization and then every 6 months until confirmed and documented progressive disease|All participants who were randomized|||||
669816|NCT01708902|Primary|The Change From Baseline in HbA1c After 12 Weeks of Treatment in APG|"The change from baseline in HbA1c after 12 weeks of treatment in additional parallel group (APG)
The mean was adjusted by baseline HbA1c and treatment group."|Baseline and week 12|FAS (LOCF)||percentage||Standard Error|Mean
669786|NCT01709162|Secondary|Disease Control Rate (DCR)|DCR is defined per arm as the total number of randomized participants with best overall response as complete response, partial response, or stable disease, divided by the total number of randomized participants in the arm. Bristol-Myers Squibb terminated this study early because the study would not meet its scientific objective in the predefined time frame. Thus, no participants were analyzed. Because the study ended before best overall response could be determined, no participants were analyzed.|Every 3 months for approximately 3.5 years after start of randomization and then every 6 months until confirmed and documented progressive disease|All participants who were randomized|||||
669787|NCT01709162|Primary|Overall Survival|Overall survival is defined for each patient as the time between randomization and death. If a patient has not died, he or she will be censored at the time of last contact (last known alive date)|From randomization to death or last known alive date, assessed up to 15.6 months|All participants who were randomized||Months||Full Range|Median
669788|NCT01709136|Secondary|SRL Prevent TAC-related Side Effects|Whether SRL can prevent or minimize progression of selected TAC-related side-effects such as renal dysfunction as measured by clearance of iothalamate (Glomerular filtration rate < 80 mL/min/1.73 m2) and hypertension (blood pressure > 140/90 mm Hg)|1 year|Due to FDA blackbox warnings from FDA (6/11/2009) about Sirolimus in liver transplant recipients (risk of thrombosis and death), the study was terminated early and data analysis was not able to be completed.|||||
669789|NCT01709136|Primary|Early and Late Pharmacokinetics of Sirolimus (SRL)|To evaluate early and late pharmacokinetics of Sirolimus (SRL) , and safety and efficacy of conversion from tacrolimus (TAC) to sirolimus in liver transplant recipients who have been stable for at least 3 months, and who have early nephrotoxicity and/or hypertension due to use of tacrolimus.|1 year|Three pharmacokinetics (PK) profiles were performed, one in each of three patients who were enrolled. However, due to FDA blackbox warnings (6/11/2009) about Sirolimus in liver transplant recipients be circumspect (risk of thrombosis and death), the study was terminated early and data analysis was not able to be completed.|||||
669790|NCT01709136|Secondary|SRL Can Substitute TAC|Whether Sirolimus can substitute Tacrolimus in the stable post-transplant state, without compromising allograft function|12 months|Due to FDA blackbox warnings (6/11/09) about Sirolimus in liver transplant recipients (risk of thrombosis and death), the study was terminated early. Due to the early termination of this study and small number of subjects enrolled (3), data analysis was not able to be completed.|||||
669791|NCT01709136|Secondary|PK Parameters for Tacrolimus and Sirolimus|pharmacokinetics (PK) of SRL after a single dose and after steady state has been achieved; and the pharmacokinetics of tacrolimus once at steady state|12 months|We were able to preform 3 pharmacokinetics (PK) profiles, one in each of three patients enrolled. However, due to emerging data and blackbox warnings from FDA suggesting that use of Sirolimus in liver transplant recipients be circumspect (risk of thrombosis and death), the study was terminated early and data analysis was not able to be completed.|||||
669792|NCT01709084|Secondary|Number of Participants With Treatment-Emergent Nucleoside Reverse Transcriptase Inhibitor (N[t]RTI) or Nucleoside/Nucleotide Reverse Transcriptase Inhibitor (NNRTI) Mutations|To compare the loss of treatment options, the number of participants with treatment-emergent N[t]RTI or NNRTI mutations, as defined by IAS-USA (2014), after virologic failure were compared between the treatment groups.|Up to Week 48|The intent-to-treat (ITT) population included all participants who were randomized and who had taken at least 1 dose of study drug.||Participants|||Number
669793|NCT01709084|Secondary|Percentage of Participant With Treatment Adherence Based on Tablet Count|In both treatment groups adherence rates assessed by tablet count, the majority of participants had an adherence of >95% (97% and 98% in RPV and EFV treated treatment groups respectively).|Up to 48 Weeks|The intent-to-treat (ITT) population included all participants who were randomized and who had taken at least 1 dose of study drug. Here, N (number of participants analyzed) signifies participants who were evaluable for this outcome measure.||Percentage of Participants|||Number
669794|NCT01709084|Secondary|Percentage of Participants With Plasma HIV-1 RNA Levels >= 50 Copies Per Milliliter (Copies/mL) at Week 48 Based on Time to Loss of Virologic Response (TLOVR) [Non-virologic Failure Censored] Imputation Method.|Percentage of participants with plasma HIV-1 RNA levels analysed based on TLOVR imputation method which is defined as confirmed plasma HIV-1 RNA >=50 copies/mL, excluding participants who discontinued the study with HIV-1 RNA suppression <50 copies/mL.|Week 48|The intent-to-treat (ITT) population included all participants who were randomized and who had taken at least 1 dose of study drug. Here, N (number of participants analyzed) signifies participants who were evaluable for this outcome measure.||Percentage of Participants|||Number
669795|NCT01709084|Secondary|Percentage of Participants With Plasma HIV-1 RNA Levels More Than or Equal to (>=) 400 Copies/mL at Week 48 Based on Time to Loss of Virologic Response (TLOVR) [Non-virologic Failure Censored] Imputation Method.|Percentage of participants with plasma HIV-1 RNA levels analysed based on time to loss of virologic response (TLOVR) imputation method which is defined as confirmed plasma HIV-1 RNA >=400 copies/mL, excluding participants who discontinued the study with HIV-1 RNA suppression <400 copies/mL.|Week 48|The intent-to-treat (ITT) population included all participants who were randomized and who had taken at least 1 dose of study drug. Here, N (number of participants analyzed) signifies participants who were evaluable for this outcome measure.||Percentage of Participants|||Number
669796|NCT01709084|Secondary|Percentage of Participants With Plasma HIV-1 RNA Levels < 50 Copies/mL at Week 48|Percentage of Participants with plasma HIV-1 RNA <50 copies/mL, obtained by the modified Food and Drug Administration (FDA) Snapshot method.|Week 48|The intent-to-treat (ITT) population included all participants who were randomized and who had taken at least 1 dose of study drug.||Percentage of Participants|||Number
669797|NCT01709084|Primary|Percentage of Participants With Plasma Human Immunodeficiency Virus – Type 1 Ribonucleic Acid (HIV-1 RNA) Levels Less Than (<) 400 Copies Per Milliliter (Copies/mL) at Week 48|Percentage of Participants with viral load (plasma HIV-1 RNA levels) less than 400 copies per mL at Week 48, obtained by the modified Food and Drug Administration (FDA) Snapshot method.|Week 48|The intent-to-treat (ITT) population included all participants who were randomized and who had taken at least 1 dose of study drug.||Percentage of Participants|||Number
669843|NCT01708057|Secondary|Maximum Increase in Diastolic Blood Pressure [DBP]|Maximum (post-dose values – baseline value) for each treatment visit.|The first 24 hours following dose administration|As the study was terminated prematurely none of the randomised patients have bean analysed.|||||
669798|NCT01708967|Primary|Success Rate of Transnasal Endoscopy|"We difine the success of transnasal endoscopy as follows: the pateint underwent transnasal endoscopy without signicant complaint nor side effects.
We difine the failure of transnasal endoscopy as follows: the patient cannot tolerate insertion of the endoscope; the patient presents side effects such as epistaxis, pain, or a decrease in O2 saturation; and the endoscope cannot pass through the nasal or oral cavity."|During transnasal endoscopy, up to 1 hours|||percentage of Participants||95% Confidence Interval|Number
669799|NCT01708967|Other Pre-specified|Satisfaction|Patients were asked to score how well they felt during endoscopy using a visual analog scale; they were also asked whether they would accept one-time spray method or spray+catheter method in the future if necessary.|after transnasal endoscopy||||||
669800|NCT01708967|Secondary|Vital Signs|Blood pressure, heart rate, and O2 saturation were assessed.|before, during, and after transnasal endoscopy||||||
669801|NCT01708954|Secondary|Proportion of Patients With Worst Grade Toxicities of Grade 3 or Higher||Assessed every 4 weeks while on treatment and for 30 days after the end of treatment|All patients who received protocol therapy||Proportion of participants||90% Confidence Interval|Number
669802|NCT01708954|Secondary|Proportion of Patients With MET Positivity|Submission of archival tissue for central MET IHC testing was required for this study, and total MET IHC testing was conducted at the Brigham and Women’s Hospital using the c-Met clone CVD13 (arabbit polyclonal). Membranous and cytoplasmic staining were individually scored, and positivity was declared if MET was expressed in either the membrane or cytoplasm.|Assessed at baseline|Eligible and treated patients who had sufficient samples for MET expression analysis.||proportion of participants||95% Confidence Interval|Number
669803|NCT01708954|Secondary|Proportion of Patients With Objective Response|Objective response is defined as complete response (CR) or partial response (PR) evaluated using RECIST v 1.1. CR is defined as disappearance of all lesions and any pathological lymph nodes must have reduction in short axis to < 10 mm. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions and persistence of one or more non-target lesion(s).|Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry, up to 5 years|Eligible and treated patients||proportion of participants||95% Confidence Interval|Number
669804|NCT01708954|Secondary|Overall Survival (OS)|OS is defined as the time from randomization to death from any cause or date of last known alive.|Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry, up to 5 years|Eligible and treated patients||months||95% Confidence Interval|Median
669805|NCT01708954|Primary|Progression-free Survival (PFS)|PFS is defined as the time from randomization to documented disease progression or death from any cause, whichever occurred first. Patients who had not experienced an event of interest by the time of analysis were censored at the date of last disease assessment.|Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry, up to 5 years|Eligible and treated patients||months||95% Confidence Interval|Median
669806|NCT01708915|Secondary|Patient Assessment of Efficacy on the Last Individual Treatment Day|Patient assessment of efficacy was assessed on a 4-point verbal rating scale (VRS, 0 = 'poor', 1 = 'fair', 2 = 'good', 3 = 'very good' relief of the patients' low back pain) in the evening of days 1, 2, 3 and 4. The last individual treatment day is the last day with diary-recorded ointment application|1 to 4 days|Patients from FAS.||participants|||Number
669807|NCT01708915|Secondary|Difference Between Baseline Pain Intensity and Average Pain Intensity on the Last Individual Treatment Day|Average pain intensity was assessed in the evening of days 1, 2, 3 and 4 on a 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst pain possible). The last individual treatment day is the last day with diary-recorded ointment application. Means were adjusted for centre effect and baseline value.|Baseline and 1 to 4 days|Patients from FAS with evaluable data for the pain intensity at baseline and for the avarage pain intensity on the last individual treatment day.||units on a scale||Standard Error|Least Squares Mean
669808|NCT01708915|Secondary|Pain Intensity Difference (PID) Between Pre-dose Baseline and 4 Hours After First Application|Pain intensity was assessed on a 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst pain possible) at pre-dose baseline and 0.5, 1, 2, 3 and 4 hours after first ointment application. Means were adjusted for centre effect and baseline value.|Baseline and 4 hours after first ointment application|Patients from FAS.||units on a scale||Standard Error|Least Squares Mean
669809|NCT01708915|Primary|Pain Intensity Difference (PID) Between Pre-dose Baseline and 8hours After First Application|Pain intensity (PI) was assessed on a 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst pain possible) at pre-dose baseline and 0.5, 1, 2, 3, 4, 6 and 8 hours after first ointment application. Means were adjusted for centre effect and baseline value.|Baseline and 8 hours after first ointment application|Patients from the Full Analysis Set (FAS): all randomised patients who used at least 1 dose of study medication and provided any post-treatment data for the pain intensity difference within 8 hours after first application.||units on a scale||Standard Error|Least Squares Mean
669810|NCT01708902|Secondary|The Frequency of Patients With Use of Rescue Therapy During 12 Week Treatment Period in APG|The Frequency of Patients With Use of Rescue Therapy During 12 Week Treatment Period in APG.|From baseline until week 12|FAS||percentage of participants||95% Confidence Interval|Number
669811|NCT01708902|Secondary|The Frequency of Patients With Use of Rescue Therapy During 24 Week Treatment Period in Main Group|"The frequency of patients with use of rescue therapy during 24 week treatment period in main group.
For this analysis the main group contrast 'Metformin 1000mg BID, Linagliptin 2.5mg / Metformin 1000mg BID' could not be analysed due to lack of events in the Metformin 1000mg BID group."|From baseline until week 24|FAS||percentage of participants||95% Confidence Interval|Number
669812|NCT01708902|Secondary|The Change in Fasting Plasma Glucose (FPG) From Baseline After 12 Weeks of Treatment in APG|"The Change in Fasting Plasma Glucose (FPG) From Baseline After 12 Weeks of Treatment in APG.
Adjusted mean: The model includes continuous baseline HbA1c, continuous baseline FPG and treatment group."|Baseline and week 12|FAS (LOCF)||mg/dL||Standard Error|Mean
669813|NCT01708902|Secondary|The Change in Fasting Plasma Glucose (FPG) From Baseline After 24 Weeks of Treatment in Main Group|"The change in fasting plasma glucose (FPG) from baseline after 24 weeks of treatment in main group.
Adjusted mean: The model includes continuous baseline HbA1c, continuous baseline FPG and treatment group."|Baseline and week 24|FAS (LOCF)||mg/dL||Standard Error|Mean
669817|NCT01708902|Primary|The Change From Baseline in HbA1c After 24 Weeks of Treatment in Main Group - FAS (OC)|"The change from baseline in HbA1c after 24 weeks of treatment in main group. Only subjects from the FAS with measured HbA1c values (observed cases [OC]) were considered.
The mean was adjusted by treatment, baseline HbA1c, week and treatment*week.
The sensitivity analysis was added as the primary analysis failed with borderline results."|Baseline and week 24|FAS (OC): subjects from the FAS with measured HbA1c values (observed cases [OC]) were considered||percentage||Standard Error|Mean
669818|NCT01708902|Secondary|The Occurrence of Treat to Target Efficacy Response in Terms of HbA1c < 6.5% After 12 Weeks of Treatment in APG|The occurrence of treat to target efficacy response in terms of HbA1c < 6.5% after 12 weeks of treatment in APG.|Week 12 (after first drug administration)|FAS (NCF)||percentage of participants||95% Confidence Interval|Number
669819|NCT01708902|Secondary|The Occurrence of Treat to Target Efficacy Response in Terms of HbA1c < 6.5% After 24 Weeks of Treatment in Main Group|The occurrence of treat to target efficacy response in terms of HbA1c < 6.5% after 24 weeks of treatment in main group.|Week 24 (after first drug administration)|FAS (NCF)||percentage of participants||95% Confidence Interval|Number
669820|NCT01708902|Secondary|The Occurrence of Treat to Target Efficacy Response in Terms of HbA1c < 7.0 % After 12 Weeks of Treatment in APG|The occurrence of treat to target efficacy response in terms of HbA1c < 7.0 % after 12 weeks of treatment in APG.|Week 12 (after first drug administration)|FAS (NCF)||percentage of participants||95% Confidence Interval|Number
669821|NCT01708902|Secondary|The Occurrence of Treat to Target Efficacy Response in Terms of HbA1c < 7.0 % After 24 Weeks of Treatment in Main Group|The occurrence of treat to target efficacy response in terms of HbA1c < 7.0 % after 24 weeks of treatment in main group.|Week 24 (after first drug administration)|FAS - non-completers were considered as nonresponders (NCF)||percentage of participants||95% Confidence Interval|Number
669822|NCT01708902|Primary|The Change From Baseline in HbA1c After 24 Weeks of Treatment in Main Group|"The change from baseline in HbA1c after 24 weeks of treatment in main group.
The mean was adjusted by baseline HbA1c and treatment group."|Baseline and week 24|Full analysis set (FAS): all randomised and treated patients who had a baseline and at least 1 on-treatment HbA1c value As the imputation rule for missing data the last observation carried forward (LOCF) was used.||percentage||Standard Error|Mean
669823|NCT01708525|Primary|Rate of Collagen Synthesis|Resected tissue will be analyzed to determine the rate of collagen synthesis in tissue treated with Ultherapy® compared to non-treated tissue.|4 weeks post-treatment|||percentage of new collagen synthesized|||Number
669824|NCT01708317|Primary|Gonorrhea and Chlamydia Testing in the Pediatric ED|"The primary outcome was change in the proportion of adolescent patients receiving chlamydia and gonorrhea testing rates during their ED visit over 4 time periods.
Period 1) 2010 testing as a historical control Period 2) Jan 2011, began providing staff education about the risks of gonorrhea/chlamydia and need for increased testing Period 3) Education continues, but enrolled patients in the ACASI from April 18, 2011 - Dec 20, 2011.
Period 4) ACASI enrollment completed, education continued through March 2012
We specifically analyzed gonorrhea/chlamydia testing among ED patients that would have been eligible to take the ACASI, had it been continuously available throughout these time periods. We did this to isolate the effects on testing by the ACASI vs. education alone."|27 months|We analyzed every patient in this time period that met our ACASI inclusion/exclusion criteria||percentage of participants|||Number
669825|NCT01708291|Primary|Number of Participants Reporting Pediatric Symptoms as Assessed by the Pediatric Symptom Checklist-17 (PSC-17)|Self Administered questionnaire to assess level of stress at baseline and week 10. PSC-17 is a one page behavioral assessment tool that can be completed in <5 minutes and can assess the sub-domains of attention, externalizing problem and internalizing problems. Attention, externalizing and Internalizing domains are each scored on a scale from 0 (best) to 10 (worst), where a score >= 7 indicates stress.|Baseline and week 10|||participants|||Number
669826|NCT01708278|Primary|Participants Who Experienced Safety Concerns, Where Safety Concerns of Quercetin Supplementation is Indicated by Significant Change From Baseline Measures of Tests Indicated Below in Outcome Measure Description|"Note: If values for any of the measures indicated here were found, the participant would be indicated as a participant with a safety concern, and values for that particular measure would be posted specifically, but since none of the participants experienced these outlying values, results of all tests are expressed here as a composite function.
PULMONARY FUNCTION TEST:
FEV1% of predicted: decline by >20% from baseline COMPLETE BLOOD COUNTS: WBC (cells)/mm3 : <2000, Platelets (cells)/mm3: <25,000, Hemoglobin (g/dL): <7.0 COMPREHENSIVE METABOLIC PROFILE (study drug related):Sodium (mmol/L): <125 or >148, Potassium (mmol/L): < 3.0 or > 6.0, Calcium (mmol/L): <7.4 or > 11.5, LIVER FUNCTION TESTS INCREASE BY FACTOR: Enzymes ALT, AST, and Alkaline phosphate, Total bilirubin: for any of these a value >3X upper limit of normal"|One week in Phase I safety study|||Participants|||Count of Participants
669827|NCT01708213|Secondary|Percentage of Participants That Were Satisfied With the Treatment as Rated by GAIS|This was measured using the Global Aesthetic Improvement Scale (GAIS). With the Global Aesthetic Improvement Scale (GAIS Scale) results of 1, 2 and 3 at 6 months were considered satisfied in this study.|6 months|||percentage of participants|||Number
669828|NCT01708213|Secondary|Number of Participants With a Decrease in the Wrinkle Severity Scale for Nasolabial Folds|"For this study, a decrease (at least one point) in the rating, relative to pre-treatment rating, when assessed by Investigators at the 1-Month, 3-Month, and 6-Month visits was considered clinically significant (P value less than 0.05).
WSS:
(0) - No wrinkle
- Just perceptible wrinkle
- Shallow wrinkle
- Moderately deep wrinkle
- Deep wrinkle, well-defined edges
- Very deep wrinkle, redundant fold"|6 months|Wrinkle Severity Score (WSS) assessment values of the Nasolabial Folds treatment area for the Per Protocol population (N=10) is a subgroup of the N=43 per protocol subjects treated. Reporting on the subjects with a 1 point improvement on the WSS at 6 months time.||participants|||Number
669829|NCT01708213|Primary|Assessment of Treatment Site Responses Post Procedure|The primary endpoint of this study is to assess treatment site responses and adverse events through 6 months post procedure.|6 months|||percentage of participants with any AE|||Number
669844|NCT01708057|Secondary|Maximum Increase in Systolic Blood Pressure [SBP]|Maximum (post-dose values - baseline value) for each treatment visit.|baseline, 24hr post dose|As the study was terminated prematurely none of the randomised patients have bean analysed.|||||
669845|NCT01708057|Secondary|Average FEV1 as a Change From Baseline|Average FEV1 (0-24h): The average over 0 to 24 hours|The first 24 hours following dose administration|As the study was terminated prematurely none of the randomized patients have been analysed.|||||
669830|NCT01708187|Primary|Change in Ankle Pain, Inflammation, Function & Activity Limitation From Baseline to 12 Months|"Ankle pain measured via visual analog scale (VAS), function measured by American Orthopaedic Foot and Ankle Society (AOFAS) ankle hindfoot scale and Foot Function Index (FFI), activity limitation measured by AOFAS scale. Images taken via thermal camera to measure inflammation were not interpretable.
VAS pain scale: 0-100, with a lower number representing a better score FFI scale: 0-100, with a lower number representing a better score AOFAS scale: 0-100, with a higher number representing a better score"|Baseline,12 months|||units on a scale|||Number
669831|NCT01708174|Secondary|Pharmacokinetics (PK): Summary of Plasma Trough Concentrations for Sonidegib (LDE225)|Blood samples were collected for assessment. The children's group was analyzed up until week 25 only.|Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49 and 53|The full analysis set (FAS) was analyzed. The FAS included all randomized and non-randomized participants who received at least one dose of study treatment.||ng/mL||Standard Deviation|Mean
669832|NCT01708174|Secondary|Overall Survival (OS) From Date First Participant Randomized, 13-Sep-2013 to Date of Data Cut-off, 15-Nov-2016|OS was defined as the time from date of randomization to date of death due to any cause. All deaths are considered, including deaths occurred after crossover for TMZ participants.|from date first participant randomized, 13-Sep-2013 to date of data cut-off, 15-Nov-2016|The full analysis set (FAS) was analyzed. The FAS included all randomized and non-randomized participants who received at least one dose of study treatment.||months||95% Confidence Interval|Median
669833|NCT01708174|Secondary|Duration of Response (DoR) According to Local Investigator Assessment From Date First Participant Randomized, 13-Sep-2013 to Date of Data Cut-off, 15-Nov-2016|DoR was defined as the time from the first documented onset of confirmed PR or CR to the date of PD/relapse or death due to medulloblastoma. DoR was evaluated by local Investigator assessment per tumor response guidelines and criteria for Medulloblastoma. TMZ participants without an event prior to crossover were censored.|from date first participant randomized, 13-Sep-2013 to date of data cut-off, 15-Nov-2016|The full analysis set (FAS) was analyzed. The FAS included all randomized and non-randomized participants who received at least one dose of study treatment.||months||95% Confidence Interval|Median
669834|NCT01708174|Secondary|Percentage of Participants With ORR According to Local Investigator Assessment From Date First Participant Randomized, 13-Sep-2013 to Date of Data Cut-off, 15-Nov-2016|ORR was defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR). ORR was evaluated by local Investigator assessment per tumor response guidelines and criteria for Medulloblastoma. Assessments after crossover were not included for TMZ patients.|from date first participant randomized, 13-Sep-2013 to date of data cut-off, 15-Nov-2016|The full analysis set (FAS) was analyzed. The FAS included all randomized and non-randomized participants who received at least one dose of study treatment.||Percentage of participants|||Number
669835|NCT01708174|Secondary|PFS According to Local Investigator Assessment From Date First Participant Randomized, 13-Sep-2013 to Date of Data Cut-off, 15-Nov-2016|PFS was defined as the time from date of randomization to the date of event defined as the first documented progression or death due to any cause. PFS was evaluated by local Investigator assessment per tumor response guidelines and criteria for Medulloblastoma.|from date first participant randomized, 13-Sep-2013 to date of data cut-off, 15-Nov-2016|The FAS was analyzed. The FAS included all randomized and non-randomized participants who received at least one dose of study treatment.||months||95% Confidence Interval|Median
669836|NCT01708174|Secondary|Progression Free Survival (PFS) According to IRC From Date First Participant Randomized, 13-Sep-2013 to Date of Data Cut-off, 15-Nov-2016|PFS was defined as the time from date of randomization to the date of event defined as the first documented progression or death due to any cause (as per tumor response guidelines and criteria for Medulloblastoma). The IRC evaluated all radiological images and applicable clinical data (i.e., neurological examination, steroid use and cerebrospinal fluid (CSF) results as applicable). TMZ participants without event prior to crossover were censored.|from date first participant randomized, 13-Sep-2013 to date of data cut-off, 15-Nov-2016|The FAS was analyzed. The FAS included all randomized and non-randomized participants who received at least one dose of study treatment.||months||95% Confidence Interval|Median
669837|NCT01708174|Primary|Percentage of Participants With Overall Response Rate (ORR) According to Independent Review Committee (IRC) From Date First Participant Randomized, 13-Sep-2013 to Date of Data Cut-off, 15-Nov-2016|ORR was defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR) (as per tumor response guidelines and criteria for Medulloblastoma). The IRC evaluated all radiological images and applicable clinical data (i.e., neurological examination, steroid use and cerebrospinal fluid (CSF) results as applicable). Assessments after crossover were not included for TMZ participants.|from date first participant randomized, 13-Sep-2013 to date of data cut-off, 15-Nov-2016|The full analysis set (FAS) was analyzed. The FAS included all randomized and non-randomized participants who received at least one dose of study treatment.||Percentage of participants|||Number
669838|NCT01708122|Secondary|O2 Saturation Post Drug Administration|After administration of the study drug, the subject is monitored (oxygen saturation), for any signs of respiratory depression or the presence of complications or side-effects including apnea or oxygen desaturation.|Baseline, 5 minutes 10 minutes and 30 minutes post drug-administration.|||percentage of O2 Saturation||Full Range|Mean
669839|NCT01708122|Primary|Pre Procedure 0 - 10 Pain Numerical Rating Scale|"The NRS pain assessment (0 = no pain to 10 = worst possible pain) is recorded as outlined below:
1. baseline pain score at admission, when the subject checks in, 2 Upon entry of the cystoscope into the urethral meatus, 3. and thirty minutes after the cystoscopic procedure has been completed."|Pre procedure, During procedure, Post procedure|||0 - 10 Pain Numerical Rating Scale||Full Range|Median
669840|NCT01708057|Secondary|PK Parameters (AZD8683)|Cmax, tmax, AUC|Pre-dose, 24hr post-dose|As the study was terminated prematurely none of the randomised patients have bean analysed.|||||
669841|NCT01708057|Secondary|Maximum Increase in QTcF|maximum (post-dose values – baseline value) for each treatment visit.|baseline, 24hr post dose|As the study was terminated prematurely none of the randomised patients have bean analysed.|||||
669842|NCT01708057|Secondary|Maximum Increase Heart Rate [HR]|Maximum (post-dose values – baseline value) for each treatment visit.|baseline, 24hr post dose|As the study was terminated prematurely none of the randomised patients have bean analysed.|||||
673923|NCT01656850|Primary|Plasma Lipid Profiles at the Baseline and at the End of 3-month Dietary Intervention||at the baseline and at the end of 3-month dietary intervention|||mg/dL||Standard Deviation|Mean
669848|NCT01707667|Secondary|Motility Index|Motility index (mmHg) was summarized for the following 3 time points: pre-dose, 0-5 hours post-dose, and 5-12 hours post-dose. The motility index is defined as the natural logarithm of all peak amplitudes of every contraction +1.|over 12 hours post-dose|The Pharmacodynamic Analysis Set consisted of all randomized subjects who had taken at least 1 dose of investigational product and who had 1 evaluable manometry assessment (minimum of 4 hours of manometry recordings from the intake of investigational product) for each treatment period.||mmHg||Standard Error|Least Squares Mean
669849|NCT01707667|Secondary|Duration of HAPC|The mean duration of all HAPCs was calculated as the sum of the duration of each HAPC divided by the number of HAPCs.|over 12 hours post-dose|The Pharmacodynamic Analysis Set consisted of all randomized subjects who had taken at least 1 dose of investigational product and who had 1 evaluable manometry assessment (minimum of 4 hours of manometry recordings from the intake of investigational product) for each treatment period.||sec||Standard Error|Least Squares Mean
669850|NCT01707667|Secondary|Propagation Velocity of HAPC|Propagation velocity was calculated as the extension divided by the duration for each HAPC. Mean propagation velocity is the sum of the propagation velocities divided by the number of HAPCs.|over 12 hours post-dose|The Pharmacodynamic Analysis Set consisted of all randomized subjects who had taken at least 1 dose of investigational product and who had 1 evaluable manometry assessment (minimum of 4 hours of manometry recordings from the intake of investigational product) for each treatment period.||cm/sec||Standard Error|Least Squares Mean
669851|NCT01707667|Secondary|Time to First HAPC|The median (95% CI) time to first HAPC after administration of investigational product with amplitude ≥100mmHg and extension ≥20cm.|over 12 hours post-dose|The Pharmacodynamic Analysis Set included all subjects in the Safety Analysis Set who had 1 evaluable manometry assessment (minimum of 4 hours of manometry recordings from the intake of investigational product) for each treatment period.||hours||95% Confidence Interval|Median
669852|NCT01707667|Secondary|The Mean Amplitude of HAPC|The mean amplitude of all HAPCs was calculated as the sum of the mean amplitude for each HAPC divided by the number of HAPCs.|over 12 hours post-dose|The Pharmacodynamic Analysis Set consisted of all randomized subjects who had taken at least 1 dose of investigational product and who had 1 evaluable manometry assessment (minimum of 4 hours of manometry recordings from the intake of investigational product) for each treatment period.||mmHg||Standard Error|Least Squares Mean
669853|NCT01707667|Secondary|Area Under the Concentration Curve (AUC) of All HAPCs|The AUC of all HAPCs during the first 12 hours after treatment was calculated as the sum of the AUC at all sensors of each HAPC at the ≥100mmHg and ≥20cm threshold.|over 12 hours post-dose|The Pharmacodynamic Analysis Set consisted of all randomized subjects who had taken at least 1 dose of investigational product and who had 1 evaluable manometry assessment (minimum of 4 hours of manometry recordings from the intake of investigational product) for each treatment period.||mmHg.sec||Standard Error|Least Squares Mean
669854|NCT01707667|Primary|The Number of High-Amplitude Propagating Contractions (HAPC)|Manometry recordings were read by an experienced gastroenterologist who was blinded to the treatment each subject received. The tracings were analyzed using computer-based validated software. HAPC and manometry data were available for every sensor as well as average values for each HAPC and manometry time point. The primary outcome analysis of HAPC data used the following threshold: Mean amplitude ≥100mmHg and extension ≥20cm (9 sensors).|over 12 hours post-dose|The Pharmacodynamic Analysis Set consisted of all randomized subjects who had taken at least 1 dose of investigational product and who had 1 evaluable manometry assessment (minimum of 4 hours of manometry recordings from the intake of investigational product) for each treatment period.||Number of HAPC with amplitude ≥100mmHg||Standard Error|Least Squares Mean
669855|NCT01707654|Other Pre-specified|Pain|Pain was given subjectively by the patient using the visual analogue scale (VAS). The VAS consists of a 10 cm line that was grouped into mild (1–3 cm), moderate (4–6 cm) and severe (7–10 cm).|17–25 months||||||
669856|NCT01707654|Secondary|Semmes-Weinstein (SW) Monofilament Test|The test points were at the center of the radial or ulnar portion of the pulp. The donor site, i.e. radial- or ulnar-dorsal aspect of the middle phalanx of the donor digit, was also evaluated.|17–25 months||||||
669857|NCT01707654|Primary|2-point Discrimination Test|The 2-point Discrimination Test determines the minimal distance at which a subject can sense the presence of two needles. The modified American Society for Surgery of the Hand guidelines were used to stratify Discriminator measurements (excellent <6 mm; good 6-10 mm; fair 11-15 mm; poor >15 mm. The test points were at the center of the radial or ulnar portion of the pulp. Each area was tested 3 times with a Discriminator (Ali Med, Dedham, MA). Two out of 3 correct answers were considered proof of perception before proceeding to another lower value. We stopped at 4 mm as a limit of 2PD and considered this normal. The assessments were performed at a single time point at the final follow up.|17-25 months|||mm||Standard Deviation|Mean
669858|NCT01707290|Secondary|Number of Participants With Serious Adverse Events (SAEs) in Observational Arm|SAE was defined as a medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, In-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event.|up to 2 years (Study 112)|Analysis population included all participants who were included in the observational arm.||participants|||Number
669859|NCT01707290|Secondary|Number of Pulmonary Exacerbations Events|Pulmonary exacerbation events include those events which require treatment with new or changed antibiotic therapy (intravenous, inhaled, or oral) for greater than or equal to 4 sinopulmonary signs/symptoms. The number of events were reported. Results were planned to be reported for Ivacaftor arm and were stratified by parent study 110, 111 and 113.|Through Week 104 (Study 112)|FAS included all participants who received at least 1 dose of study drug (Ivacaftor).||pulmonary exacerbation events|||Number
669870|NCT01707238|Primary|Handling|Participant’s subjective rating for lens handling of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (0-10, 10= very easy).|two weeks and four weeks from baseline visit|||units on a scale||Standard Deviation|Mean
669871|NCT01707225|Secondary|Need for Blood Transfusion and Hospital Admission for GI Bleed||24 weeks|||participants||95% Confidence Interval|Number
673924|NCT01656850|Primary|The Major Nutrients of NCEP Step 2 Diet and Almond Diets||the entire study, up to 3 months|||% of energy||Standard Deviation|Mean
669860|NCT01707290|Secondary|Absolute Change From Baseline in Respiratory Domain of the Cystic Fibrosis Questionnaire Revised (CFQ-R) at Week 2, 12, 24, 36, 48, 60, 72, 84, 96 and 104|The CFQ-R is a validated participant reported outcome measuring health related quality of life for participants with CF. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), score range: 0-100; higher scores indicating fewer symptoms and better health related quality of life. Baseline was defined as the most recent measurement before intake of the first dose of study drug (ivacaftor) in Study 112. Results were planned to be reported for Ivacaftor arm and were stratified by parent study 110, 111 and 113.|Baseline, Week 2, 12, 24, 36, 48, 60, 72, 84, 96 and 104 (Study 112)|"FAS included all participants who received at least 1 dose of study drug (ivacaftor). Here, Number Analyzed signifies those participants who were evaluable for this measure at the specified time point for each arm respectively."||units on a scale||Standard Deviation|Mean
669861|NCT01707290|Secondary|Absolute Change From Baseline in Sweat Chloride at Week 2, 24, 48 and 104|Sweat samples were collected using an approved collection device. Baseline was defined as the most recent measurement before intake of the first dose of study drug (Ivacaftor) in Study 112. Results were planned to be reported for Ivacaftor arm and were stratified by parent study 110, 111 and 113.|Baseline, Week 2, 24, 48 and 104 (Study 112)|"FAS included all participants who received at least 1 dose of study drug (Ivacaftor). Here, Number of participants analyzed signifies those participants who were evaluable for this outcome and Number Analyzed signifies those participants who were evaluable for this measure at the specified time point for each arm respectively."||millimole per liter (mmol/L)||Standard Deviation|Mean
669862|NCT01707290|Secondary|Absolute Change From Baseline in Body Mass Index (BMI) at Week 2,12, 24, 36, 48, 60, 72, 84, 96 and 104|BMI was defined as weight in kg divided by height in m^2. Baseline was defined as the most recent measurement before intake of the first dose of study drug (Ivacaftor) in Study 112. Results were planned to be reported for Ivacaftor arm and were stratified by parent study 110, 111 and 113.|Baseline, Week 2, 12, 24, 36, 48, 60, 72, 84, 96 and 104 (Study 112)|"FAS included all participants who received at least 1 dose of study drug (Ivacaftor). Here, Number analyzed signifies those participants who were evaluable for this measure at the specified time point for each arm, respectively."||kilogram per square meter (kg/m^2)||Standard Deviation|Mean
669863|NCT01707290|Secondary|Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Week 2, 12, 24, 36, 48, 60, 72, 84, 96, and 104|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, and height). The Hankinson standard was used for male participants 18 years and older and female participants 16 years and older. The Wang standard was used for male participants aged 6 to 17 years and for female participants aged 6 to 15 years. Baseline was defined as the most recent measurement before intake of the first dose of study drug (Ivacaftor) in Study 112. Results were planned to be reported for Ivacaftor arm and were stratified by parent study 110, 111 and 113.|Baseline, Week 2, 12, 24, 36, 48, 60, 72, 84, 96 and 104 (Study 112)|"Full Analysis Set (FAS) included all participants who received at least 1 dose of study drug (Ivacaftor). Here, Number Analyzed signifies those participants who were evaluable for this measure at the specified time point for each arm, respectively."||Percent predicted of FEV1||Standard Deviation|Mean
669864|NCT01707290|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs) in Ivacaftor Arm|AE: any untoward medical occurrence in a participants during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after informed consent form is signed. AE includes serious as well as non-serious AEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, In-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. TEAEs were defined as adverse events with start date or increased severity on and after the first dose of study drug through Week 108.|Day 1 up to Week 108 (Study 112)|Safety Set included all participants who received at least 1 dose of study drug (Ivacaftor).||participants|||Number
669865|NCT01707238|Secondary|Satisfaction With Comfort|Participant’s subjective rating for overall satisfaction of lens comfort of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (5 point Likert scale - Completely Dissatisfied, Somewhat Dissatisfied, Neither, Somewhat Satisfied, Completely Satisfied).|two weeks and four weeks from baseline visit|||percentage of participants|||Number
669866|NCT01707238|Secondary|Satisfaction With Dryness|Participant’s subjective rating for overall satisfaction of lens dryness of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (5 point Likert scale - Completely Dissatisfied, Somewhat Dissatisfied, Neither, Somewhat Satisfied, Completely Satisfied).|two weeks and four weeks from baseline visit|||percentage of participants|||Number
669867|NCT01707238|Primary|Satisfaction With Handling|Participant’s subjective rating for overall satisfaction of lens handling of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (5 point Likert scale - Completely Dissatisfied, Somewhat Dissatisfied, Neither, Somewhat Satisfied, Completely Satisfied).|two weeks and four weeks from baseline visit|||percentage of participants|||Number
669868|NCT01707238|Secondary|Dryness|Participant’s subjective rating for overall lens dryness of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (0-10, 10=no dryness).|two weeks and four weeks from baseline visit|||units on a scale||Standard Deviation|Mean
669869|NCT01707238|Secondary|Comfort|Participant’s subjective rating for overall lens comfort of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (0-10, 10=can't feel).|two weeks and four weeks from baseline visit|||units on a scale||Standard Deviation|Mean
669872|NCT01707225|Primary|Number of Participants With Side-Effects|"Cardiovascular:
Sinus bradycardia (19% to 25%) Hypertension (≤13%) conduction abnormalities (9% to 10%)
Central nervous system:
Fatigue (1% to 32%) headache (6% to 30%) malaise (16% to 20%) fever (16% to 20%) dizziness (5% to 20%) Pain (4% to 15%)
Dermatologic:
Pruritus (≤18%) Rash (15%; depot formulation) alopecia (≤13%)
Endocrine & metabolic:
Hyperglycemia (2% to 27%)
Gastrointestinal:
Abdominal pain (5% to 61%) loose stools (5% to 61%) nausea (5% to 61%) diarrhea (34% to 58%) flatulence (≤38%) cholelithiasis (13% to 38%; length of therapy dependent) constipation (9% to 21%) vomiting (4% to 21%)
Hematologic Anemia (5-15%)
Local:
Injection site pain (2% to 50%; dose and formulation related)
Neuromuscular & skeletal:
Back pain (1% to 27%) arthropathy (8% to 19%) myalgia (≤18%)
Renal Kidney Stones (5-15%)
Respiratory:
Upper respiratory infection (10% to 23%)
Miscellaneous:
flu symptoms (1% to 20%)"|24 weeks|||participants||95% Confidence Interval|Number
669873|NCT01707095|Secondary|Histologic Evidence of Burn at the Epigastric Port Site Skin.|Shave biopsy of skin at the epigastric port site after elective laparoscopic cholecystectomy will be performed. The secondary outcome is histologic evidence of burn at this port site.|1 day|||participants|||Number
669874|NCT01707095|Primary|Histologic Thermal Injury to Umbilical Port Site Skin|Shave biopsy of skin at the umbilical port site after elective laparoscopic cholecystectomy will be performed. The primary outcome is histologic evidence of burn at these port sites.|1 day|||participants|||Number
669875|NCT01707043|Primary|Subjective Subject Preference Survey for the Second Treatment Session|Subjective Subject Preference Survey The Subjective Subject Preference Survey consist of 15 questions relating to patients preference of study drug. The survey includes questions such as how the medication feels to touch, how greasy it is, and time it takes to apply. The final question asks patients to rate the overall appeal of the vehicle. Questions are scored on a 7-point scale, where a score of 1 is extremely unpleasant, 4 is neutral, and a score of 7 is extremely appealing. Total preference score based on the Subjective Subject Preference Survey could range from 15-105.|3 days|||units on a scale||Standard Deviation|Mean
669876|NCT01707043|Primary|Subjective Subject Preference Survey for the First Treatment Session|Subjective Subject Preference Survey The Subjective Subject Preference Survey consist of 15 questions relating to patients preference of study drug. The survey includes questions such as how the medication feels to touch, how greasy it is, and time it takes to apply. The final question asks patients to rate the overall appeal of the vehicle. Questions are scored on a 7-point scale, where a score of 1 is extremely unpleasant, 4 is neutral, and a score of 7 is extremely appealing. Total preference score based on the Subjective Subject Preference Survey could range from 15-105.|3 days|||units on a scale||Standard Deviation|Mean
669877|NCT01706965|Primary|Final MATRICS Cognitive Battery|MATRICS assessing 7 domains (Speed of Processing, Attention/Vigilance, Working Memory, Verbal Learning, Visual Learning, Reasoning and Problem Solving, and Social Cognition. Raw scores are converted into a composite T-score (normative mean = 50; standard deviation = 10), where higher values indicated less impairment.|Baseline to week 6|||Total MATRICS score||Standard Deviation|Mean
669878|NCT01706965|Primary|Final Positive and Negative Symptom Scale (PANSS)|This is a is a 30 item rating scale widely used in the assessment of schizophrenia ranging from 30-210. Higher scores are worse|Baseline (start of Kuvan) and at six weeks of treatment|||PANSS Total||Standard Deviation|Mean
669879|NCT01706952|Secondary|End Tidal CO2|"The concentration of carbon dioxide (CO2) in the respiratory gases will be recorded every 15 minutes or until 300 minutes.
For the secondary objective of concentration of carbon dioxide, we calculated the mean within sides treated with cocaine vs adrenaline and assessed its difference"|Every 15 minutes or until 300 minutes|||Percentage of carbon dioxide||Standard Deviation|Mean
669880|NCT01706952|Secondary|Blood Pressure|"The mean blood pressure, defined as the average arterial pressure during a single cardiac cycle, will be recorded every 15 minutes, until the surgery is over or until 300 minutes.
For the secondary objective of blood pressure, we calculated the mean within sides treated with cocaine vs adrenaline and assessed its difference"|Every 15 minutes or until 300 minutes|||mmHg||Standard Deviation|Mean
669881|NCT01706952|Secondary|Heart Rate|"The heart rate (heart beats for minutes) will be recorded every 15 minutes, until the surgery is over or until 300 minutes.
The Co-investigator will record this data in a special data sheeet For the secondary objective of Heart rate, we calculated the average within sides treated with cocaine vs adrenaline and assessed its difference"|Every 15 minutes until 300 minutes|||Heart Beats per minute||Standard Deviation|Mean
669882|NCT01706952|Primary|To Estimate the Change in Bleeding Category (Surgical Field Improvement) as Measured on a Six-point Scale, Measured From 0 (Best Case) to 5 (Worst Case).|"0 No bleeding.
Slight bleeding - no suctioning of blood required.
Slight bleeding - occasional suctioning required. Surgical field not threatened.
Slight bleeding - frequent suctioning required. Bleeding threatens surgical field a few seconds after suction is removed.
Moderate bleeding - frequent suctioning required. Bleeding threatens surgical field directly after suction is removed.
Severe bleeding - constant suctioning required. Bleeding appears faster than can be removed by suction. Surgical field severely threatened and surgery not possible.
For the primary objective of surgical field grade, we calculated the mean within sides treated with cocaine vs adrenaline and assessed its difference"|Every 15 minutes until 300 minutes|EACH SIDE WAS EVALUATED SEPARATELY||units on a scale||Standard Deviation|Mean
669883|NCT01706926|Secondary|Percentage of Participants Exhibiting Anti-Drug Antibodies (ADAs) to Mavrilimumab at Any Visit|Immunogenicity assessment included determination of anti-drug (mavrilimumab) antibodies in serum samples. ADA detection measured by using electrochemiluminescence assays.|Day 1 to Day 169|The immunogenicity population included all participants who received at least 1 dose of mavrilimumab and for whom at least one serum sample for immunogenicity testing was available.||percentage of participants|||Number
669884|NCT01706926|Secondary|Serum Concentrations of Mavrilimumab|Serum concentrations after multiple subcutaneous doses of mavrilimumab were calculated for each cohort (30mg, 100mg and 150mg). Geometric coefficient of variation at Baseline for cohorts 30mg and 150mg were calculated as the negligible mean value was observed.|Baseline, Day 8, 15, 29, 85, 141, and 169|"The pharmacokinetic (PK) population included all participants who received mavrilimumab and for whom serum concentrations of mavrilimumab were available for PK data analyses. Here n signifies participants who were evaluable for the specified time point for each arm, respectively."||nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
669980|NCT01705574|Secondary|Change From Baseline in CD4+ Cell Count at Week 48 of the Double-Blind Phase||Baseline; Week 48|Participants in the ITT Analysis Set with available data were analyzed.||cells/μL||Standard Deviation|Mean
669885|NCT01706926|Secondary|Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-fatigue) at Day 169|FACIT-F is a 13-item questionnaire questionnaire to measure the degree of fatigue experiences by participants in the previous 7 days. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant’s response to the questions (with the exception of 2 negatively stated), greater was the participant’s fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant’s response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score) where higher sore represent less fatigue.|Baseline and Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||units on a scale||Standard Error|Mean
669886|NCT01706926|Secondary|Percentage of Participants With American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Remission at Day 169|ACR/EULAR remission was defined as swollen joint count (0-66), tender joint count (0-68), CRP (mg/dL) and participant global assessment (0-10) all less than or equal to one.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.||percentage of participants|||Number
669887|NCT01706926|Secondary|Percentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Day 169|The CDAI was the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, patient global assessment and physician global assessment assessed on 0 - 10 cm VAS. The CDAI total score ranges from 0 to 76 where higher scores indicates greater affection due to disease activity. CDAI remission was defined as a score less than or equal to 2.8.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.||percentage of participants|||Number
669888|NCT01706926|Secondary|Percentage of Participants With Simplified Disease Activity Index (SDAI) Remission at Day 169|The SDAI was the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, patient global assessment and physician global assessment assessed on 0 - 10 cm VAS; and C-reactive protein (CRP) (milligram per deciliter [mg/dL]). The SDAI total score ranges from 0 to 86, where higher scores indicates greater affection due to disease activity. SDAI remission was defined as a score less than or equal to 3.3.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.||percentage of participants|||Number
669889|NCT01706926|Secondary|Ratio of Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Day 169|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. The farther the red blood cells have descended, the greater the inflammatory response.|Baseline, Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here N (Number of participants analyzed) signifies those participants who were evaluable for this measure."||ratio||Geometric Coefficient of Variation|Geometric Mean
669890|NCT01706926|Secondary|Ratio of Change From Baseline in C-Reactive Protein (CRP) at Day 169|CRP is a substance produced by the liver that increases in the presence of inflammation in the body. The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement in underlying disease.|Baseline, Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here N (Number of participants analyzed) signifies those participants who were evaluable for this measure."||ratio||Geometric Coefficient of Variation|Geometric Mean
669891|NCT01706926|Secondary|Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Day 169|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item was scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range from 0 to 3; where 0 = least difficulty and 3 = extreme difficulty.|Baseline and Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||units on a scale||Standard Error|Mean
669892|NCT01706926|Secondary|Mean Change From Baseline in Physician Global Assessment of Disease Activity (MDGA) at Day 169|Physician Global Assessment of Arthritis was measured by asking the physician to assess the participant's current arthritis disease activity by placing a vertical line on a 0 to 10 centimeter (cm) VAS, where 0 cm = very good and 10 cm = very bad.|Baseline and Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||cm||Standard Error|Mean
669893|NCT01706926|Secondary|Mean Change From Baseline in Patient Global Assessment (PGA) of Disease Activity at Day 169|"Participants responded to a question, Considering all the ways your arthritis affects you, how are you feeling today? by using a 0 - 100 millimeter (mm) VAS, where 0 = very well and 100 = very poorly."|Baseline and Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||mm||Standard Error|Mean
669894|NCT01706926|Secondary|Mean Change From Baseline in Patient Assessment of Pain at Day 169|Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.|Baseline and Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||mm||Standard Error|Mean
669983|NCT01705496|Other Pre-specified|Estimate the Sensitivity and Specificity of Plain X-ray in Detecting Prosthetic Joint Infection|"The adjudication committee evaluation of a subject's infection status will be used as the standard of truth to which X-ray is compared.
The trial failed primary outcome, and this secondary outcome was not analyzed."|15 mins||||||
669895|NCT01706926|Secondary|Mean Change From Baseline in Swollen and Tender Joint Count at Day 169|Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form, no swelling = 0, swelling =1. Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form, no tenderness = 0, tenderness = 1.|Baseline and Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||joint count||Standard Error|Mean
669896|NCT01706926|Secondary|Percentage of Participants With DAS28 (CRP) Remission and Low Disease Activity at Day 169|DAS28 (CRP) calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and CRP (mg/L). Total score range: 0-9.4, higher score= more disease activity. Remission was defined as less than 2.6 DAS28 (CRP) score. Low disease activity was defined as less than 3.2 DAS28 (CRP) score.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.||percentage of participants|||Number
669897|NCT01706926|Secondary|Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 169|DAS28 (CRP) response by EULAR category were used to measure individual response as none, moderate, and good, depending on the extent of change from baseline and the level of disease activity reached. Good response: change from baseline >1.2 with baseline DAS28 (CRP) <3.2; moderate response: change from baseline >1.2 with baseline DAS28 (CRP) >=3.2 to less than or equal to (=<) 5.1 or change from baseline >=0.6 to =< 1.2 with baseline DAS28 (CRP) >=3.2 to =<5.1; no response: change from baseline <0.6 or change from baseline >=0.6 and =<1.2 with baseline DAS28 (CRP) >5.1.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.||percentage of participants|||Number
669898|NCT01706926|Secondary|Change From Baseline in Continuous American College of Rheumatology (ACRn) Score at Day 169|ACR score - continuous (ACRn) was defined as the minimum of the percentage improvement in TJC, SJC and the median of the percentage improvements in the other five components of the ACR criteria (participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; disability index of the HAQ; and CRP). Total score range was -100 to 100, where negative numbers indicated worsening and positive numbers indicated improvement.|Baseline up to Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||units on a scale||Standard Error|Mean
669899|NCT01706926|Secondary|Percentage of Participants Who Achieved American College of Rheumatology 70 (ACR70) Responses at Day 169|ACR70 was defined as >=70% improvement, in: SJC and TJC and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.||percentage of participants|||Number
669900|NCT01706926|Secondary|Percentage of Participants Who Achieved American College of Rheumatology 50 (ACR50) Responses at Day 169|ACR50 was defined as >=50% improvement, in: SJC and TJC and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.||percentage of participants|||Number
669901|NCT01706926|Secondary|Oxygen Saturation Level at Day 169|Oxygen saturation measured by pulse oximetry which measures the concentration of oxygen in the blood.|Day 169|"The safety population included all participants who received any dose of investigational product. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||percent saturation||Standard Deviation|Mean
669902|NCT01706926|Secondary|Dyspnea Score at Day 169|Borg dyspnea scale is a validated participant reported outcome assessing participant’s perceived difficulty in breathing (dyspnea). The scale ranges from 0 (nothing at all) to 10 (maximal difficulty). Higher scores indicate greater difficulty in breathing.|Day 169|"The safety population included all participants who received any dose of investigational product. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||units on a scale||Standard Deviation|Mean
669903|NCT01706926|Secondary|Percentage of Pulmonary Function Test Values Below Threshold Values at Day 169|Pulmonary function testing were performed by spirometry to assess forced expiratory volume in 1 second (FEV1), forced expiratory volume in 6 second (FEV6), and forced vital capacity (FVC). FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FEV6 was the maximal volume of air exhaled in the six second of a forced expiration from a position of full inspiration. FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. The percentage of predicted values of these pulmonary function tests were calculated based on decreases from baseline and categorized as less than or equal to (=<) 15 percent (%), more than (>) 15 to =<20%, and >20%.|Day 169|"The safety population included all participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified threshold value mentioned parameter for each arm, respectively."||percent of pulmonary test values|||Number
669904|NCT01706926|Secondary|Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)|Vital sign assessments included blood pressure, pulse rate, temperature, weight and respiration rate. Vital signs abnormalities reported as TEAEs were reported.|Baseline up to Day 169|The safety population included all participants who received any dose of investigational product.||participants|||Number
670011|NCT01704781|Secondary|Part B: Evaluate the Effect on HIV Viral Load|Results BLQ (<20 HIV copies/mL) have been replaced with BLQ/2 = 10 HIV copies/mL while ‘not detected’ results have been replaced with 0 HIV copies/mL.|26 weeks|ITT analysis set||Copies/mL||Standard Deviation|Mean
669905|NCT01706926|Secondary|Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)|Any medically significant change in laboratory evaluations were recorded as adverse events. Following parameters were analyzed for laboratory examination: hematology (haemoglobin, absolute neutrophil count, leukocyte count, platelet count), serum chemistry (alanine transaminase, aspartate transaminase, bilirubin, gamma-glutamyl transferase), other serum chemistry (low-density lipoprotein cholesterol, triglycerides), and urinalysis.|Baseline up to Day 169|The safety population included all participants who received any dose of investigational product.||participants|||Number
669906|NCT01706926|Secondary|Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and Day 169 that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to Day 169|The safety population included all participants who received any dose of investigational product.||percentage of participants|||Number
669907|NCT01706926|Primary|Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20) Responses at Day 169|ACR20 was defined as >=20 percent (%) improvement, in: SJC and TJC and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and CRP.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.||percentage of participants|||Number
669908|NCT01706926|Primary|Change From Baseline in Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Score at Day 85|DAS28 (CRP) calculated swollen joint count (SJC) and tender joint count (TJC) using the 28 joints, general health (GH) using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and CRP (milligram per liter [mg/L]). Total score range: 0-9.4, higher score= more disease activity. DAS28 (CRP) less than (<) 3.2 = low disease activity, greater than or equal to (>=) 3.2 to 5.1 = moderate to high disease activity and <2.6= remission. A Day 85 responder was defined as a participant who experienced more than 1.2 decrease from baseline in DAS28 (CRP) score at Day 85.|Baseline and Day 85|"The modified intent-to-treat (mITT) population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||units on a scale||Standard Error|Mean
669909|NCT01706822|Secondary|Maneuverability Measured by Surgeon Usability Questionnaire. The Reported Values Represent Percentage of Cases Surgeon Agree/Strongly Agree|3. Maneuverability measured by surgeon usability questionnaire Question: Maneuverability of Radial reload during the procedure was adequate|Operatively|||% of cases surgeon agree/strongly agree|||Number
669910|NCT01706822|Secondary|Visibility Measured by Surgeon Usability Questionnaire. The Reported Values Represent Percentage of Cases Surgeon Agree/Strongly Agree|2. Visibility measured by surgeon usability questionnaire|Operatively|||% of cases surgeon agree/strongly agree|||Number
669911|NCT01706822|Secondary|Access Measured by Surgeon Usability Questionnaire. The Reported Values Represent Percentage of Cases Surgeon Agree/Strongly Agree|1. Access measured by surgeon usability questionnaire.|Operatively|||% of cases surgeon agree/strongly agree|||Number
669912|NCT01706822|Primary|The Ability to Achieve Adequate Distal Margins (Defined as >2cm [or >1cm With Clear Histologic Evaluation]) in the Low Rectum. The Reported Value Represents the Number of Participants in Whom the Criteria Was Met|The ability to achieve adequate distal margins (defined as >2cm [or >1cm with clear histologic evaluation]) in the low rectum.|Operative|||participants|||Number
669913|NCT01706822|Primary|The Surgeon's Ability to Achieve a Staple Line at the Desired Level of the Rectum. The Reported Value Represents the Number of Participants in Whom the Criteria Was Met|The surgeon’s ability to achieve a staple line at the desired level of the rectum.|Operative|||participants|||Number
669914|NCT01706770|Primary|Comparison of Objective Findings - Number of Adverse Events in Unique Eyes|"The primary safety endpoint are the objective findings of the number of adverse events in unique eyes associated with the enfilcon A contact lenses compared with those same findings as associated with the galyfilcon A contact lenses.
The number of adverse events over the duration of the study was reported for each unique eye (bilateral or unilateral). Observations for adverse events were reported for any occurrence from Baseline through end of month 1 visit."|Any occurrence from baseline to 1 month visit|Unique eyes are defined as each individual eye in the study.||number of adverse events|Participants||Number
669915|NCT01706770|Primary|Objective Assessment: Ocular Response - Biomicroscopy|"The primary safety endpoint are the objective slit lamp findings associated with the enfilcon A contact lenses compared with those same findings reported as associated with the galyfilcon A contact lenses.
The incidence of biomicroscopy findings (0=not present, 4=severe) over the duration of the study with the highest reported grade was chosen for each unique eye. Biomicroscopy measurements were obtained at Baseline/Dispensing (baseline and dispensing visit combined), Post-Dispensing (after lenses were dispensed and allowed to settle) and All Follow-Ups (week 1 visit, week 2 visit, month 1 visit combined). The average grade for unique eyes with findings greater than 0 (none) is compared."|Change from baseline/dispensing visits, post-dispensing visit and all follow-ups visits|Unique eyes are defined as each individual eye in the study and are only counted once for each of the visit groupings.||units on a scale|Participants|Full Range|Mean
669916|NCT01706666|Secondary|Progression-free Survival|The distribution of progression-free survival will be estimated by arm using the method of Kaplan-Meier.|From registration to the earliest date of documentation of disease progression or death due to any cause, assessed up to 3 years|||Months to Progression|||Number
669917|NCT01706666|Secondary|Survival Time|The distribution of survival time will be estimated by arm using the method of Kaplan-Meier.|From registration to death due to any cause, assessed up to 3 years|All patients are still alive||Months to death|||Number
670012|NCT01704781|Secondary|Part B: Change in CD8 Count|Change in CD8 count from baseline to week 26.|26 weeks|Not all patients had quantifiable blood samples/counts at all time points||10^6 cells/L||Standard Deviation|Mean
669918|NCT01706666|Primary|Proportion of Patients Experiencing a Stringent Complete Response (sCR) After 12 Cycles, 24 Months|Estimated by the number of sCRs divided by the total number of evaluable patients in each arm. Exact binomial confidence intervals for the true sCR rate will be calculated by arm. Stringent complete response (sCR) is defined as a complete response plus normal serum free light chain ratio and the absence of clonal cells in bone marrow by flow cytometry.|24 months|||percentage of participants|||Number
669919|NCT01706588|Secondary|Number of Patients With Adverse Events||from signature of the informed consent to 1 week postsurgery||||||
669920|NCT01706588|Secondary|Vital Signs||presurgery (within 30 days from surgery), at day of surgery (day 1), day 3 and 1 week postsurgery.||||||
669921|NCT01706588|Secondary|Recurrent Bleeding||every hour up to 6 hour postsurgery||||||
669922|NCT01706588|Secondary|Wound Healing||at 6 hour postsurgery, and on day 3 and 1 week postsurgery||||||
669923|NCT01706588|Secondary|Time to Onset of Pain||measured from end of surgery up to 12 hours postsurgery||||||
669924|NCT01706588|Secondary|Patient and Investigator Global Evaluation of the Effectiveness of Treatment||at 6 hour postsurgery and on Day 3||||||
669925|NCT01706588|Secondary|Rescue Medication Consumption||consumed by the patient from end of surgery up to 24 and up to 48 hours postsurgery||||||
669926|NCT01706588|Secondary|Amount of Rescue Medication||consumed by the patient every 15-minutes postsurgery up to 6 hours postsurgery||||||
669927|NCT01706588|Secondary|Time to First Use of Rescue Medication.||measured from end of surgery up to 1 week postsurgery||||||
669928|NCT01706588|Secondary|Peak Pain Intensity||measured from end of surgery up to 12 hours postsurgery||||||
669929|NCT01706588|Secondary|Trismus||measured at 6 hours postsurgery, at day 3 and 1 week postsurgery||||||
669930|NCT01706588|Secondary|Postsurgical Extra-oral Swelling||measured at 6 hours postsurgery, at day 3 and 1 week postsurgery||||||
669931|NCT01706588|Primary|Area Under the Curve (AUC) of the Pain Scores.|Pain will be scored by the patient at the end of surgery (time 0) and at 15-minute intervals after surgery for a total of 6 hours on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).|Pain scores will be measured over the time from end of surgery (time 0) to the 6 hour post-surgery|||mm*minutes||Standard Deviation|Mean
669932|NCT01706575|Secondary|Safety: Percentage of Participants With Adverse Events (AE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Baseline up to Week 48|Safety population included all participants who received least one dose of the study drug and had at least one post-dose safety assessment.||percentage of participants|||Number
669933|NCT01706575|Secondary|Efficacy: HBsAg Levels According to Interferon-Inducible Protein 10 (IP-10) Serum Levels||Baseline and Week 48|Data were not collected, and the outcome measure was not analyzed.|||||
669934|NCT01706575|Secondary|Efficacy: HBsAg Levels According to Interleukin 28B (IL28B) Genotypes||Baseline and Week 48|Data were not collected, and the outcome measure was not analyzed.|||||
669935|NCT01706575|Secondary|Efficacy: Number of Participants With Serum HBsAg Loss at Week 12 That Persisted up to Week 96|HBsAg loss is defined as HBsAg less than or equal to (</=) 0.05 IU/ml.|Week 12 up to Week 96|PP included all participants without severe protocol violations, including major inclusion or exclusion criteria violations.||participants|||Number
669936|NCT01706575|Secondary|Efficacy: Percentage of Participants With HBsAg Decrease >/=1 log10 IU/ml From Baseline to Week 48||Baseline, Week 48|PP included all participants without severe protocol violations, including major inclusion or exclusion criteria violations and who were undergoing the Week 48 visit.||percentage of participants|||Number
669937|NCT01706575|Secondary|Efficacy: Change From Baseline in Serum Hepatitis B Surface Antigen (HBsAg) Titer at Week 24, 72 and 96|Change is calculated by HBsAg titer at baseline - HBsAg titer at week of assessments.|Baseline, Week 24, 72 and 96|PP included all participants without severe protocol violations, including major inclusion or exclusion criteria violations. Here, number of participants analyzed signifies those participants who were evaluable for the outcome measure and n signifies the number of participants who were evaluated at specified time points.||international units per millilitre||Standard Deviation|Mean
669938|NCT01706575|Primary|Efficacy: Percentage of Participants With Serum Hepatitis B Surface Antigen (HBsAg) Decrease >/= 50% From Baseline at End of the Combination Treatment (Week 48)|Participants who stopped pegylated interferon (PEG-IFN) treatment during the add-on phase due to serum HBsAg loss and HBsAg seroconversion were considered as responders.|Baseline and Week 48|PP included all participants without severe protocol violations, including major inclusion or exclusion criteria violations and who were undergoing the Week 48 visit.||percentage of participants|||Number
669939|NCT01706575|Primary|Efficacy: Percent Change From Baseline in Serum Hepatitis B Surface Antigen (HBsAg) Titer at End of the Combination Treatment (Week 48)||Baseline up to Week 48|Per-Protocol Population (PP) included all participants without severe protocol violations, including major inclusion or exclusion criteria violations.||percent change||Standard Deviation|Mean
669940|NCT01706549|Secondary|Is the Pain Due to Hysterectomy?|Number of patients having posthysterectomy pain versus other pain|1-3 years|||participants|||Number
669941|NCT01706549|Secondary|Quality of Life After Hysterectomy|Quality of life as measured by the SF-36, which consists of 8 scales.|1-3 years after hysterectomy||||||
669942|NCT01706549|Primary|Type of Chronic Pain After Hysterectomy|Number of participants with probable neuropathic, possible neuropathic, pain had subsided and other type of pain.|1-3 years after hysterectomy|Women undergone hysterectomy previously and reported having pain at the site of surgery six months after surgery||participants|||Number
669943|NCT01706328|Secondary|Change From Baseline in Trough FEV1 on Treatment Day 85|FEV1 is a measure of lung function and is defined as the volume of air that can be forcefully exhaled in one second. Trough FEV1 is defined as the 24-hour FEV1 assessment, which was obtained on Day 85. Baseline trough was calculated as the mean of the two assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1. Change from Baseline was calculated as the average of the Day 85 values minus the Baseline value. The analysis used an analysis of covariance (ANCOVA) model with covariates of Baseline FEV1, reversibility stratum, smoking status (at Screening), country, and treatment.|Baseline and Day 85|ITT Population. Only those participants available at the indicated time point were assessed.||Liters||Standard Error|Least Squares Mean
669944|NCT01706328|Secondary|Time to Onset on Treatment Day 1|Time to onset on Treatment Day 1 is defined as the time to an increase of 100 milliliters (mL) from Baseline in FEV1 during the 0- to 4-hour serial measurements (5, 15, 30, 60, 120, and 240 minutes post-dose). Participants who never met or exceeded a 100 mL increase over the Baseline value during the 4-hour serial measurements were censored at the actual time of their last FEV1 measurement.|Baseline and Day 1|ITT Population. Only those participants available at the indicated time point were assessed.||Minutes||Full Range|Median
669945|NCT01706328|Primary|Change From Baseline Trough in Weighted-mean 24-hour Serial Forced Expiratory Volume in One Second (FEV1) on Treatment Day 84|FEV1 is a measure of lung function and is defined as the volume of air that can be forcefully exhaled in one second. The weighted mean was calculated from the pre-dose FEV1 and the post-dose FEV1 measurements taken at 5, 15, 30, and 60 minutes and 2, 4, 6, 8, 12, 13, 14, 16, 20, and 24 hours on Treatment Day 84. Baseline trough FEV1 was calculated as the mean of the two assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1. The weighted mean was derived by calculating the area under curve, and then dividing by the relevant time interval. The weighted mean change from Baseline was calculated as the weighted mean of the 24-hour serial FEV1 measurements on Day 84 minus the Baseline trough FEV1 value. The analysis used an analysis of covariance (ANCOVA) model with covariates of Baseline FEV1, reversibility stratum, smoking status (at Screening), country, and treatment.|Baseline and Day 84|Intent-to-Treat (ITT) Population: all participants who were randomized and received at least one dose of study drug. Only those participants available at the indicated time point were assessed.||Liters||Standard Error|Least Squares Mean
669946|NCT01706250|Secondary|Mean Change in Each of the Participant Assessments of Tolerability-Scaling|This was a tolerability variable, where the participants were instructed to individually assess the right and the left side of the face to indicate the severity that they had experienced during the time period from their last visit for scaling. The area on the face was assessed excluding nose, nasogenian, and superior and inferior eyelids. The assessment of the scaling was graded on 0 to 5 scale based on severity by the participant; 0=None, 1=Very minimal, 2=mild, 3= moderate, 4=severe, and 5= Very severe. Thus higher score indicated more severity. BL was defined as Day 1. The mean change was calculated as value at each individual visit (Wks 1,2,4 and 8) minus the value at BL respectively.|BL (Day 1) to Wks 1, 2, 4 and 8|ITT population. Only those participants available at the specified time points we re analyze d (represented by n=X, X in the category titles).||units on scale||Standard Deviation|Mean
669947|NCT01706250|Secondary|Mean Change in Each of the Participant Assessments of Tolerability-Itching|This was a tolerability variable, where the participants were instructed to individually assess the right and the left side of the face to indicate the severity that they had experienced during the time period from their last visit for itching. The area on the face was assessed excluding nose, nasogenian, and superior and inferior eyelids. The assessment of the itching was graded on 0 to 5 scale based on severity by the participant; 0=None, 1=Very minimal, 2=mild, 3= moderate, 4=severe, and 5= Very severe. Thus higher score indicated more severity. BL was defined as Day 1. The mean change was calculated as value at each individual visit (Wks 1,2,4 and 8) minus the value at BL respectively.|BL (Day 1) to Wks 1, 2, 4 and 8|ITT population. Only those participants available at the specified time points we re analyze d (represented by n=x, x in the category titles).||units on scale||Standard Deviation|Mean
669948|NCT01706250|Secondary|Mean Change in Each of the Participant Assessments of Tolerability-Burning|This was a tolerability variable, where the participants were instructed to individually assess the right and the left side of the face to indicate the severity that they had experienced during the time period from their last visit for burning. The area on the face was assessed excluding nose, nasogenian, and superior and inferior eyelids. The assessment of the burning was graded on 0 to 5 scale based on severity by the participant; 0=None, 1=Very minimal, 2=mild, 3= moderate, 4=severe, and 5= Very severe. Thus higher score indicated more severity. BL was defined as Day 1. The mean change was calculated as value at each individual visit (Wks 1, 2, 4 and 8) minus the value at BL respectively.|BL (Day 1) to Wks 1,2, 4 and 8|ITT population. Only those participants available at the specified time points we re analyze d (represented by n=x, x in the category titles).||units on scale||Standard Deviation|Mean
669949|NCT01706250|Secondary|Mean Change in Each of the Participant Assessments of Tolerability-Dryness|This was a tolerability variable, where the participants were instructed to individually assess the right and the left side of the face to indicate the severity that they had experienced during the time period from their last visit for dryness. The area on the face was assessed excluding the excluding nose, nasogenian, and superior and inferior eyelids. The assessment of the dryness was graded on 0 to 5 scale based on severity by the participant. 0=None, 1=Very minimal, 2=mild, 3= moderate, 4=severe, and 5= Very severe. Thus higher score indicated severity of the disease. BL was defined as Day 1. The mean change was calculated as value at each individual visit (Wks 1,2,4 and 8) minus the value at BL respectively.|BL (Day 1) to Wks 1, 2, 4 and 8|ITT population . Only those participants available at the specified time points we re analyze d (represented by n=x, x in the category titles).||units on scale||Standard Deviation|Mean
669950|NCT01706250|Secondary|Mean Change in Each of the Participant Tolerability Assessments-Redness|This was a tolerability variable, where the participants were instructed to individually assess the right and the left side of the face to indicate the severity that they had experienced during the time period from their last visit for redness. The area on the face was assessed excluding the excluding nose, nasogenian, and superior and inferior eyelids. The assessment of the redness was graded on 0 to 5 scale based on severity by the participant. 0=None, 1=Very minimal, 2=mild, 3= moderate, 4=severe, and 5= Very severe. Thus higher score indicated more severity. BL was defined as Day 1. The mean change was calculated as value at each individual visit (Wks 1,2,4 and 8) minus the value at BL respectively.|BL (Day 1) to Wks 1, 2, 4 and 8|ITT population. Only those participants available at the specified time points we re analyze d (represented by n=x, x in the category titles).||units on scale||Standard Deviation|Mean
669981|NCT01705574|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 of the Double-Blind Phase|The snapshot algorithm was used which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Intent-to-treat (ITT) Analysis Set: participants who were randomized and received at least one dose of study drug.||percentage of participants|||Number
670013|NCT01704781|Primary|Part B: Change in CD4 Count|Change in CD4 count from baseline to Week 26.|Week 26|Analysis was performed for both the Intent To Treat (ITT) and Per Protocol (PP) analysis set.||10^6 cells/L||Standard Deviation|Mean
669951|NCT01706250|Secondary|Mean Change in Each of the Evaluator Tolerability Assessments-Peeling|This was a tolerability variable. The expert grader (blinded evaluator) assessed each left and right side of the face individually at each study visit. The areas on the face excluding nose, nasogenian, and superior and inferior eyelids were evaluated. The evaluator conducting the assessment for the participant remained blinded for the treatment assigned. The assessment of the peeling was graded on 0 to 5 scale based on severity by the evaluator. 0=None, 1=Very minimal, 2=mild, 3= moderate, 4=severe, and 5= Very severe. Thus higher score indicated more severity. BL was defined as Day 1. The mean change was calculated as value at each individual visit (Wk 1,2,4 and 8) minus the value at BL respectively. The change from BL was '0' for Wk (1, 4 and 8) and hence statistical analysis was not done.|BL (Day 1) to Wks 1, 2, 4 and 8|ITT population. Only those participants available at the specified time points were analyze d (represented by n=x, x in the category titles).||units on scale||Standard Deviation|Mean
669952|NCT01706250|Secondary|Mean Change in Each of the Evaluator Tolerability Assessments-Dryness|This was a tolerability variable. The expert grader (blinded evaluator) assessed each left and right side of the face individually at each study visit. The areas on the face excluding nose, nasogenian, and superior and inferior eyelids were evaluated. The evaluator conducting the assessment for the participant remained blinded for the treatment assigned. The assessment of the dryness was graded on 0 to 5 scale based on severity by the evaluator. 0=None, 1=Very minimal, 2=mild, 3= moderate, 4=severe, and 5= Very severe. Thus higher score indicated more severity. BL was defined as Day 1. The mean change was calculated as value at each individual visit (Wk 1,2,4 and 8) minus the value at baseline respectively. The change from BL was '0' for Wk 2, Wk 4, and Wk 8 and hence statistical analysis was not done.|BL (Day 1) to Wks 1, 2, 4 and 8|ITT population. Only those participants available at the specified time points we re analyze d (represented by n=X, X in the category titles).||units on scale||Standard Deviation|Mean
669953|NCT01706250|Secondary|Mean Change in Each of the Evaluator Tolerability Assessments-Erythema|This was a tolerability variable. The expert grader (blinded evaluator) assessed each left and right side of the face individually at each study visit. The areas on the face excluding nose, nasogenian, and superior and inferior eyelids were evaluated. The evaluator conducting the assessment for the participant remained blinded for the treatment assigned. Erythema is condition characterized by redness or rash on the skin. The assessment of the erythema was graded on 0 to 5 scale based on severity by the evaluator. 0=None, 1=Very minimal, 2=mild, 3= moderate, 4=severe, and 5= Very severe. Thus higher score indicated severity of the disease. BL was defined as Day 1. The mean change was calculated as value at each individual visit (wk 1,2,4 and 8) minus the value at BL respectively. The change from BL was '0' for Wk 4 and Wk 8, and hence statistical analysis was not done.|BL (Day 1) to Wks 1, 2, 4 and 8|ITT population. Only those participants available at the specified time points we re analyze d (represented by n=X, X in the category titles).||units on scale||Standard Deviation|Mean
669954|NCT01706250|Secondary|Mean Change in Investigator’s Static Global Assessment (ISGA) From BL (Day 1) to Wks 1, 2, 4 and 8.|The evaluator (blinded) evaluated the acne severity of the participants' face using the ISGA scale ranging from 0 to 5. The grading was 0= Clear, skin with no IL or NILs; 1= Almost clear, rare NILs with no more than one small IL ; 2= Mild, some NILs with no more than few ILs (papules/pustules only, no nodular lesions); 3= Moderate Upto many NILs and may have some ILs but no more than one small nodular lesion ; 4= Severe, Upto many NILs and ILs but no more than a few nodular lesions; 5= Very severe, many NILS and ILs more than a few nodular lesions, may have cystic lesions. Thus higher score indicated severity of the disease. BL was defined as Day 1. The mean change was calculated as value at each visit (Wks 1,2,4 and 8) minus the value at BL respectively.|BL (Day 1) to Wks 1, 2, 4 and 8|ITT population. Only those participants available at the specified time points we re analyze d (represented by n=x, x in the category titles).||units on scale||Standard Deviation|Mean
669955|NCT01706250|Secondary|Mean Percent Change in TL Count From BL (Day 1) to Wks 1, 2 and 4|This was an efficacy variable. An expert grader (blinded) evaluated the left and the right side of the face extending from the hairline to the mandible (included forehead, cheeks and chin). The evaluator assessed the total lesions by the sum of both inflammatory and non-inflammatory lesions on each side (left side and right side). The mouth, nose, periocular area, nasogenian, and superior and inferior eyelids were excluded. BL was defined as Day 1. The percent change was calculated as the percent value (count of total lesions) at each individual visit (percent value at Wks 1, 2 and 4) minus the value at baseline respectively.|BL (Day 1) to Wks 1, 2 and 4|ITT population. Only those participants available at the specified time points we re analyze d (represented by n=X, X in the category titles).||percent change in lesion count||Standard Deviation|Mean
669956|NCT01706250|Secondary|Mean Percent Change in NIL Count From BL (Day 1) to Wks 1, 2 and 4|This was an efficacy variable. An expert grader (blinded) evaluated the left and the right side of the face extending from the hairline to the mandible (included forehead, cheeks and chin). The evaluator assessed the NIL by the presence of open and closed comedones. The mouth, nose, periocular area, nasogenian, and superior and inferior eyelids were excluded. BL was defined as Day 1. The percent change was calculated as the percent value (count of NIL) at each individual visit (percent value at Wk 1, 2 and 4) minus the value at BL respectively.|BL (Day 1) to Wks 1, 2 and 4|ITT population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).||percent change in lesion count||Standard Deviation|Mean
669957|NCT01706250|Secondary|Mean Percent Change in IL Count From BL (Day 1) to Wks 1, 2 and 4|This was an efficacy variable. An expert grader (blinded) evaluated the left and the right side of the face extending from the hairline to the mandible (included forehead, cheeks and chin). The evaluator assessed the IL by counting the number of papules and pustules. The mouth, nose, periocular area, nasogenian, and superior and inferior eyelids were excluded. BL was defined as Day 1. The percent change was calculated as the percent value (count of IL) at each individual visit (percent value at wk 1, 2 and 4) minus the value at BL respectively.|BL (Day1) to Wks 1, 2 and 4|ITT used. Only those participants available at the specified time points were analyzed (re presented by n=x, x in the category titles).||percent change in lesion count||Standard Deviation|Mean
669982|NCT01705496|Other Pre-specified|Determine the Sensitivity and Specificity of [124I]FIAU vs. Plain X-ray in Detecting Prosthetic Joint Infection|"The adjudication committee evaluation of a subject’s infection status will be used as the standard of truth to which [124I]FIAU and X-ray are compared.
The trial failed primary outcome, and this secondary outcome was not analyzed."|30 hours||||||
669958|NCT01706250|Primary|Mean Percent Change in Inflammatory Lesion (IL), Non-inflammatory Lesion (NIL), and Total Lesion (TL) Counts From Baseline (BL) (Day 1) to Week (Wk) 8.|This was an efficacy variable. An expert grader evaluated each side of the face (included forehead, cheeks and chin), the left and the right side, for IL (presence of papules and pustules), NIL (presence of open and closed comedones) and the TLs. The mouth, nose, periocular area, nasogenian, and superior and inferior eyelids were excluded. The evaluator was also blinded. BL was defined as Day 1. The percent change was calculated as the value at Wk 8 minus the value at BL.|BL (Day 1) and Wk 8|The Intent to treat (ITT) analysis set included data from all randomized participants who received the study drug. The number of participants available at that particular time point were used for analysis.||percent change in lesion count||Standard Deviation|Mean
669959|NCT01706159|Secondary|Maximum Concentration (Cmax) of rFXIII|The peak plasma concentration of the drug after dose administration.|Samples were collected before and up to 72 hours after the first dose of rFXIII.|It was not possible to obtain credible single dose PK for rFXIII in this trial due to a small number of subjects with required PK measurements and a spurious behaviour of individual PK profiles.|||||
669960|NCT01706159|Secondary|Clearance (CL) of rFXIII|The volume of plasma cleared of the drug per unit time.|Samples were collected before and up to 72 hours after the first dose of rFXIII.|It was not possible to obtain credible single dose pharmakokinetics (PK) for rFXIII in this trial due to a small number of subjects with required PK measurements and a spurious behaviour of individual PK profiles.|||||
669961|NCT01706159|Secondary|Number of Adverse Events (AEs)|Number of adverse events reported from the first trial-related activity, after the subject was exposed to the trial drug, until the end of the post-treatment follow-up period.|Week 0 to 10|Safety analysis set included all randomised and treated subjects.||events|||Number
669962|NCT01706159|Secondary|Remission (Clinical and Endoscopic)|Analysis of responders defined by a clinical component of: ulcerative colitis disease activity index (UC-DAI) score of less than or equal to 1 with 0 for rectal bleeding and 0 for stool frequency and an endoscopic component of: no mucosal friability (modified Baron score less than or equal to 1).|At Week 8|Full analysis set (FAS) included all randomised and treated subjects. Two subjects in the rFXIII group had no UC-DAI score at any visit, including baseline and they were excluded from the analysis.||Subjects|||Number
669963|NCT01706159|Primary|Endoscopic Remission Defined as a Modified Baron Score of 0|"The primary endpoint was the binary variable (responder vs. non-responder) where responders were the subjects with endoscopic remission (endoscopic mucosal healing) at Week 8, defined as a modified Baron score of 0. Subjects with a modified Baron score ≥1 were designated as “non-responders”."|At week 8|Full analysis set (FAS) included all randomised and treated subjects.||Subjects|||Number
669964|NCT01706146|Other Pre-specified|Stroke-free Survival Rate|To assess the stroke-free survival rate with implantable monitor-guided intermittent anticoagulation.|12 months||||||
669965|NCT01706146|Other Pre-specified|Major Bleeding-free Survival Rate|To assess the major bleeding-free survival rate with implantable monitor-guided intermittent anticoagulation.|12 months||||||
669966|NCT01706146|Other Pre-specified|Overall Survival|To assess the overall survival rate with implantable monitor-guided intermittent anticoagulation.|12 months||||||
669967|NCT01706146|Other Pre-specified|Stroke Rate|To assess the stroke rate with implantable monitor-guided intermittent anticoagulation.|12 months||||||
669968|NCT01706146|Secondary|Bleeding Incidence|To assess the bleeding incidence with implantable monitor-guided intermittent anticoagulation.|up to 12 months|||participants|||Number
669969|NCT01706146|Primary|Number of Days on Anticoagulation|Assess subject anticoagulant utilization and number of days on anticoagulation|up to 12 months|||days||Standard Deviation|Mean
669970|NCT01705717|Secondary|Percentage of Participants Who Died|Any cause of death (including non-liver disease related) was reported.|Diagnosis and End of Study, up to 36 months after diagnosis|All enrolled participants||percentage of participants|||Number
669971|NCT01705717|Secondary|Percentage of Participants Who Progressed From CHC to Hepatocellular Carcinoma (HCC)||Diagnosis and End of Study, up to 36 months after diagnosis.|All enrolled participants||percentage of participants|||Number
669972|NCT01705717|Secondary|Percentage of Participants Who Progressed From CHC to Cirrhosis||Diagnosis and End of Study, up to 36 months after diagnosis.|All enrolled participants||percentage of participants|||Number
669973|NCT01705717|Secondary|Percentage of Participants With HCV Relapse (Biochemical or Virological) After Treatment Completion|HCV relapse was determined by PCR RNA diagnostic testing. Virological relapse was defined as subsequent reappearance of serum HCV RNA after completion of therapy in participants who achieved end of treatment virological response (undetectable HCV RNA). Biochemical relapse was defined as subsequent rise in serum alanine aminotransferase (ALT) level after end of treatment with normal ALT.|End of Study, up to 36 months after diagnosis.|All enrolled participants;||percentage of participants|||Number
669974|NCT01705717|Secondary|Percentage of Participants Who Were HCV Seronegative at the End of Treatment|End-of-treatment response (ETR) was defined as a negative result upon PCR RNA diagnostic testing at the end of treatment.|End of Study, up to 36 months after diagnosis.|All enrolled participants||percentage of participants|||Number
669975|NCT01705717|Primary|Sustained Virological Response (SVR): Percentage of Participants Who Were HCV Seronegative at 6 Months After Completing Therapy|SVR was defined a negative result upon polymerase chain reaction (PCR) ribonucleic acid (RNA) diagnostic testing after 6 months of treatment.|6 months|All enrolled participants.||percentage of participants|||Number
669976|NCT01705652|Primary|PSA (Prostate Specific Antigen)|PSA decline to < 1.0 ng/ml at 3 months post end of radiation or surgery|3 months post end of radiation treatment or surgery|Radiation Group: One subject who did not complete the study was included as he did stay in the study through the 3 month post radiation treatment time period, and dropped out after that time.||participants|||Number
669977|NCT01705574|Secondary|Change in CD4+ Cell Count at Week 48 of the Open-Label Extension Phase||Baseline; Open-Label Extension Week 48||||||
669978|NCT01705574|Secondary|Percentage of Participants Receiving E/C/F/TDF or ATV+RTV+FTC/TDF With HIV-1 RNA < 50 Copies/mL at Week 48 of the Open-Label Extension Phase||Open-Label Extension Week 48||||||
669979|NCT01705574|Secondary|Percentage of Participants Receiving Open-Label E/C/F/TDF With HIV-1 RNA < 50 Copies/mL at Week 48 of the Open- Label Extension Phase|The snapshot algorithm was used which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Open-Label Extension Week 48||||||
669984|NCT01705496|Other Pre-specified|Explore Whether the Adjudication Committee Evaluation of a Subject's Infection Status Correlates With Either of the Two Proposed Published Standards|"An independent adjudication committee will assess the totality of clinical information from each subject and assign them a status of infected or uninfected. The subject's infection status will be compared with either of the two proposed published standards to determine whether it corelates with any of the current consensus definitions or diagnostic algorithms.
The trial failed primary outcome, and this secondary outcome was not analyzed."|30 +/- 2 days||||||
669985|NCT01705496|Secondary|Understand the Prevalence of Prosthetic Joint Infection|The trial failed primary outcome, and this secondary outcome was not analyzed|30 +/- 2 days||||||
669986|NCT01705496|Secondary|Define PET-CT Interpretation Criteria That Best Differentiate Infected vs Non-infected Prosthetic Joints|The efficacy of [124I]FIAU could not be established due to the non-specific nature of the PET-CT signals caused by the metal artifacts from the prosthesis and pronounced muscle uptake of FIAU. It was impossible to define image review parameters for diagnosis of prosthetic joint infection.|30 +/- 2 days||||||
669987|NCT01705496|Secondary|Evaluate the Safety and Tolerability of [124I]FIAU|Safety will be monitored throughout the study for all subjects. safety will be assessed by monitoring of adverse events,vital signs,physical exams, and clinical laboratory tests including CBC, serum chemistry.|30 +/- 2 days|22 received the investigational drug. A single IV injection of 5 mCi [124I]FIAU was well tolerated in patients presenting with pain in a prosthetic joint.||participants with adverse events|||Number
669988|NCT01705496|Primary|Estimate the Sensitivity and Specificity of [124I]FIAU|"The sensitivity and specificity of [124I]FIAU in the detection of prosthetic joint infection was determined based on the correlation of the patient’s infection status determined by an independent image reviewer and the infection status assessed by an adjudication committee.
Presence or absence of infection: Images were to be assessed and optimized on an ongoing basis. The single blinded reader was to assess independently the PET-CT images (attenuation corrected [AC] and non-AC PET plus the AC CT) and provide a diagnosis (infected or uninfected) using the chosen parameter(s) without knowing the results of the surgery. The radiology reviewer was not given any additional clinical information on the patient for reassessments relative to the initial reads. A separate central radiologist was to read the comparator X-rays independently for the presence or absence of infection. All pathology slides were to be read by a single pathologist. Local microbiology results were to be used."|30 hours|Out of 23 enrolled, only 22 received the investigational drug. One subject withdrew.||percentage of participants||80% Confidence Interval|Number
669989|NCT01705145|Secondary|Part B: Absolute Change From Baseline in Body Mass Index (BMI) at Week 24|BMI = (Weight [in kg]) divided by (Stature [in meters])^2. Data was reported as per the dose received and for overall participants.|Baseline, Week 24|Part B Safety set included all participants who received at least 1 dose of study drug in part B. Number of participants analyzed is for participants who were evaluable for this outcome measure.||kilogram per square meter (kg/m^2)||Standard Deviation|Mean
669990|NCT01705145|Primary|Part A: Plasma Concentration of Ivacaftor and Its Metabolites|Plasma concentration was reported for ivacaftor and its metabolites (hydroxymethyl ivacaftor [M1] and ivacaftor carboxylate [M6]) up to 24 hours post-dose on Day 4 (Hour 0 [pre-dose] on Day 1 and Day 4; 2, 3, 6, 24 hours post-dose on Day 4). Data was planned to be reported for overall participants in the period.|Part A: up to 24 hours post-dose on Day 4|Part A Safety set included all participants who received at least 1 dose of study drug in part A.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
669991|NCT01705145|Secondary|Part B: Absolute Change From Baseline in Stature at Week 24|Stature was measured as height if children could stand unassisted and follow directions; otherwise, stature was measured as length. Data was reported as per the dose received and for overall participants.|Part B: Baseline, Week 24|Part B Safety set included all participants who received at least 1 dose of study drug in part B. Number of participants analyzed is for participants who were evaluable for this outcome measure.||centimeters (cm)||Standard Deviation|Mean
669992|NCT01705145|Secondary|Part B: Absolute Change From Baseline in Weight at Week 24|Data was reported as per the dose received and for overall participants.|Part B: Baseline, Week 24|Part B Safety set included all participants who received at least 1 dose of study drug in part B. Number of participants analyzed is for participants who were evaluable for this outcome measure.||kilograms (kg)||Standard Deviation|Mean
669993|NCT01705145|Secondary|Part B: Absolute Change From Baseline in Sweat Chloride at Week 24|Sweat samples were collected using an approved Macroduct (Wescor, Logan, Utah) collection device. A volume of greater than or equal to (>=) 15 microliter was required for determination of sweat chloride. Data was reported as per the dose received and for overall participants.|Part B: Baseline, Week 24|Part B Safety set included all participants who received at least 1 dose of study drug in part B. Number of participants analyzed is for participants who were evaluable for this outcome measure.||millimole per liter (mmol/L)||Standard Deviation|Mean
669994|NCT01705145|Secondary|Part B: Plasma Concentration of Ivacaftor and Its Metabolites|Plasma concentration was reported for ivacaftor and its metabolites (M1 and M6) up to 24 hours post-dose on Day 168 (Hour 0 [predose] on Day 1, 14, 56, 112, and 168; 2, 3, 6 hours post-dose on Day 14; 1 hour post-dose on Day 56; 4, 6 hours post-dose on Day 112; 24 hours post-dose on Day 168). Data was planned to be reported for overall participants in the period.|Part B: up to 24 hours post-dose on Day 168|Part B Safety set included all participants who received at least 1 dose of study drug in part B.||ng/mL||Standard Deviation|Mean
669995|NCT01705145|Primary|Part B: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Related AEs|"AE: any adverse change from participant's baseline (pre-treatment) condition, including any adverse experience, abnormal recording/clinical laboratory assessment which occurs during course of study, whether it is considered related to study drug or not. AE includes both serious and non-serious AE. SAE: medical event or condition, which falls into any of following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolonged hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect, important medical event.
Related AEs includes all AEs for which the causality was either related to study drug or possibly related to study drug. Data was reported as per the dose received."|Part B: Up to 28 Weeks|Part B Safety set included all participants who received at least 1 dose of study drug in part B.||participants|||Number
670014|NCT01704781|Primary|Part A: To Establish Highest Tolerated Dose of Lenalidomide, CD4 Counts Over Time||31 days|ITT analysis set was used.||10^6 cells/mL||Standard Deviation|Mean
669996|NCT01705145|Primary|Part A: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Related AEs|"AE: any adverse change from participant's baseline (pre-treatment) condition, including any adverse experience, abnormal recording/clinical laboratory assessment which occurs during course of study, whether it is considered related to study drug or not. SAE: medical event or condition, which falls into any of following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolonged hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect, important medical event.
Related AEs includes all AEs for which the causality was either related to study drug or possibly related to study drug. Data was reported as per the dose received and for overall participants."|Part A: Up to 93 Days|Part A Safety set included all participants who received at least 1 dose of study drug in part A.||participants|||Number
669997|NCT01704976|Secondary|Isometric Rate of Force Development (IRFD) Left Knee-extensor|It will be evaluated by isometric RFD (Newton/seconds) at 90 degree angle in the knee joint.|after 4 weeks|||Newton/seconds||Inter-Quartile Range|Median
669998|NCT01704976|Secondary|Isometric Rate of Force Development (IRFD) Right Knee-extensor|It will be evaluated by isometric RFD (Newton/seconds) at 90 degree angle in the knee joint.|after 4 weeks|||Newton/seconds||Inter-Quartile Range|Median
669999|NCT01704976|Secondary|Ismometric Maximal Voluntary Contraction (IMVC) Left Knee-extension|It will be evaluated by isometric MCV (Newton) at 90 degree angle in the knee joint.|after 4 weeks|||Newton||Inter-Quartile Range|Median
670000|NCT01704976|Secondary|Isometric Maximum Voluntary Contraction (IMCV) in Newton (N) Right Knee-extensor|It will be evaluated by isometric MCV (Newton) at 90 degree angle in the knee joint.|after 4 weeks|||Newton||Inter-Quartile Range|Median
670001|NCT01704976|Primary|Physical Functional Performance|"Short physical performance battery (SPBB): The SPBB examines 3 areas of lower extremity function: standing balance (semi-tandem stand, side-by-side stand, full tandem stand), usual walking speed and ability to stand from a chair. These areas represent essential tasks important for independent living.
The scores range from 0 (worst performance) to 12 (best performance). SPPB 0-6 is “Poor performance”; SPPB 7-9 is “Intermediate performance; SPPB 10-12 is “High Performance”."|after 4 weeks|||units on a scale||Inter-Quartile Range|Median
670002|NCT01704846|Secondary|Mean Residence Time (MRTpo)|Mean residence time of the analyte in the body after oral administration. Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.|3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration|Pharmacokinetic (PK) set included all healthy subjects in the treated set who have evaluable pharmacokinetic variable in the treatment periods.||hour|Participants|Geometric Coefficient of Variation|Geometric Mean
670003|NCT01704846|Secondary|Terminal Half-life (t1/2)|Terminal half-life of faldaprevir in plasma. Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.|3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration|Pharmacokinetic (PK) set included all healthy subjects in the treated set who have evaluable pharmacokinetic variable in the treatment periods.||hours|Participants|Geometric Coefficient of Variation|Geometric Mean
670004|NCT01704846|Secondary|Terminal Rate Constant (λz)|Terminal rate constant of the analyte in plasma. Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.|3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration|Pharmacokinetic (PK) set included all healthy subjects in the treated set who have evaluable pharmacokinetic variable in the treatment periods.||1/h|Participants|Geometric Coefficient of Variation|Geometric Mean
670005|NCT01704846|Secondary|Time From Dosing to the Maximum Measured Concentration (Tmax)|"Time from dosing to the maximum measured concentration of the analyte in plasma.
Means presented are adjusted means and the standard deviation is actually the intra-individual coefficient of variation."|3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration|Pharmacokinetic (PK) set included all healthy subjects in the treated set who have evaluable pharmacokinetic variable in the treatment periods.||hours|Participants|Standard Deviation|Mean
670006|NCT01704846|Secondary|Area Under the Curve Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)|"Area under the concentration-time curve of faldaprevir in plasma over the time interval from 0 extrapolated to infinity.
Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation."|3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration|Pharmacokinetic (PK) set included all healthy subjects in the treated set who have evaluable pharmacokinetic variable in the treatment periods.||ng*h/mL|Participants|Geometric Coefficient of Variation|Geometric Mean
670007|NCT01704846|Primary|Maximum Measured Concentration (Cmax)|Maximum measured concentration of faldaprevir in plasma. Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.|3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration|Pharmacokinetic (PK) set included all healthy subjects in the treated set who have evaluable pharmacokinetic variable in the treatment periods.||ng/mL|Participants|Geometric Coefficient of Variation|Geometric Mean
670008|NCT01704846|Primary|Area Under the Curve of the Analyte From Time 0 to the Last Quantifiable Data Point (AUC0-tz)|"Area under the concentration-time curve of the faldaprevir in plasma over the time interval from 0 to the time of the last quantifiable data point.
Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation."|3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration|Pharmacokinetic (PK) set included all healthy subjects in the treated set who have evaluable pharmacokinetic variable in the treatment periods.||ng·h/mL|Participants|Geometric Coefficient of Variation|Geometric Mean
670009|NCT01704781|Secondary|Part A and B: Safety and Tolerability||Part A: 31 days and Part B: 26 weeks|||participants|||Number
670010|NCT01704781|Secondary|Part B: Incidents of Delayed-type Hypersensitivity|Delayed-type hypersensitivity measured by induration and erythema.|26 weeks|The IIT population was used for this outcome measure. Data for one patient was not reported at week 26.||Participants|||Count of Participants
670016|NCT01704755|Secondary|Percentage of Participants With Virologic Relapse After Treatment|Participants were considered to have virologic relapse after treatment if they had confirmed quantifiable plasma Hepatitis C virus ribonucleic acid (HCV RNA) ≥ lower limit of quantification (LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA < LLOQ at the end of treatment.|within 12 weeks after the last dose of study drug|All randomized participants who received at least 1 dose of study drug with HCV RNA < LLOQ at the final treatment visit who completed treatment.||Percentage of participants||95% Confidence Interval|Number
670017|NCT01704755|Secondary|Percentage of Participants in Each Arm With On-treatment Virologic Failure During the Treatment Period|Virologic failure during treatment was defined as rebound (confirmed HCV RNA greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA < LLOQ during treatment, or confirmed increase from the lowest value post baseline in HCV RNA [2 consecutive HCV RNA measurements > 1 log(subscript)10(subscript) IU/mL above the lowest value post baseline] at any time point during treatment), or fail to suppress (HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks [≥ 36 days] of treatment).|Baseline (Day 1), and Treatment Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24|All randomized participants who received at least 1 dose of study drug.||Percentage of participants||95% Confidence Interval|Number
670018|NCT01704755|Secondary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment in the 24-week Arm Compared to the 12-week Arm|A sustained virologic response is defined as plasma Hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (< LLOQ) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of study drug|All randomized participants who received at least 1 dose of study drug.||Percentage of participants|||Number
670019|NCT01704755|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment|The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of study drug|All randomized participants who received at least 1 dose of study drug.||Percentage of participants|||Number
670020|NCT01704651|Secondary|Postoperative Ileus Incidence|Ileus was defined as MD-diagnosed, return to nothing by mouth (NPO) status, or insertion of nasogastric tube for ileus.|Patients will be followed for 30 days postop|Intent to treat analysis||participants|||Number
670021|NCT01704651|Primary|Postoperative Length of Hospital Stay|Length of stay = date/time of hospital dismissal - date/time of end of surgery|Patients will be followed for the duration of their hospital stay, an expected average of 5 days|Intent to Treat analysis||days||Standard Deviation|Mean
670022|NCT01704599|Post-Hoc|EKG Categoryy Changes Related to Homocysteine Changes|Change in EKG ( normalize, unchanged, became abnormal) when homocysteine (Hcy) increased or decreased from week 16 on adalimumab to week 28 on adalimumab plus folic acid, vitamins B6 and B12 in adault psoriasis patients ages 18-65 with moderate to severe plaque psoriasis.|Week 16 to Week 28|8 adults with moderate to severe plaque psoriasis ages 18-65. 4 were studied. Four were not because homocysteine levels at both Week16 nd 28 were not drawn(1 of the 4 had SAE prior to Week 16).||participants|||Number
670023|NCT01704599|Post-Hoc|Psoriasis Change in Participants With High H. Pylori Titers and With Normal Titers.|Change in PASI from Week 16 after 16 weeks of adalimumab to Week 28 after another 12 weeks of adalimumab plus folic acid, vitamins B6 and B12 and Change reported by telephone 70 days after week 28|Week 16 to Week 28 and Week 28 to post study day 70|8 Adults ages 18-65 with moderate tosevere plaque psoriasis. 7 subjects studied. The 8th had SAE prior to Week 16.||participants|||Number
670024|NCT01704599|Post-Hoc|PASI Change in Participants With Baseline VEGF Above 140 pg/ml and in Participants With Normal Baseline VEGF|Baseline VEGF level at week zero related to PASI change Week 16 on adalimumab compared to Week 28 after additonal 12 weeks of adalimumab plus folic acid, vitamin B6 and B12 in adult psoriasis patients ages 18-65 with moderate to severe plaque psoriasis.High levels were greater than or equal to 140 pg/ml. Normal VEGF was below this level.|Week 16 and Week 28|8 adult participants with moderate to severe plaque psoriasis ages 18 to 65. Seven were analyzed. The one not analyzed had SAE prior to week16.||participants|||Number
670025|NCT01704599|Post-Hoc|PASI Change Related to Baseline Body Mass Index Above, Below and Equal to 27.3|Change in PASI from Week 16 on adalimumab to Week 28 on adalimumab, folic acid, vitamin B6 and B12 in adults ages 18-65 with moderate to severe plaque psoriasis.|Week 16 and Week 28|8 Adult subjects ages 18-65 with moderate to severe plaque psoriasis. 7 had PASI data both Week 16 and Week 28. The 1 who did not had SAE prior to Week 16.||participants|||Number
670026|NCT01704599|Primary|Number of Particpants With a Categorical PASI (Psoriasis Area and Severity Index) Change|PASI: formula based on body surface areas on head/neck, trunk, both arms & legs with disease quality grading induration, scale and erythema on participants ages 18-65 with moderate to severe plaque psoriasis measured at weeks 16 and 28.|Weeks 16 and 28|8 adults ages 18-65 with moderate to severe plaque psoriasis. Seven of 8 had PASI measured at weeks 16 and 28. One had SAE prior to week 16.||participants|||Number
670027|NCT01704599|Other Pre-specified|Number of Participants Within the Categories of Increasign and Decreasing Body Weight|Weight is how heavy a participant is. Weight in pounds of each study adult participant age 18-65 years with moderate to severe plaque psoriasis measured at weeks 16 and compared to week 28 of study.|Week 16 and Week 28|8 adults ages 18-65 with moderate to severe plaque psoriasis. Seven of 8 had weights taken weeks 0,4,16 and 28 allowing week16 and 28 analysis. One had weight taken only at weeks 0 and 4.||participants|||Number
670028|NCT01704599|Other Pre-specified|Number of Participants Who Fulfilled the Category of Having Height Measured|Height is the distance from the bottom (soles of feet ) to the top (top of head) of a person when that person is standing in this study using ruler in inches.Participants measured were adults age 18 or older with moderate to severe plaque psoriasis.|Week 0 at Start of Adalimumab|8 Adults with mild to moderate plaque psoriasis had their height measured at week 0 in inches.||participants|||Number
670029|NCT01704599|Other Pre-specified|Number of Participants Within Categories of Body Temperature Change|Using a thermometer for body temperature on degrees Fahrenheit. Participants to be measured were adults 18 years or older with moderate to severe plaque psoriasis with temperature to be measured at week 16 16 weeks of adalimumab and week 28 after 16 weeks of adalimumab then 12 weeks of adalimumab plus 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg of B12.|Weeks 16 and 28|8 Subjects. Five had temperatures measured weeks 16 and 28. Three did not (one of the 3 had SAE prior to week16)||participants|||Number
670030|NCT01704599|Other Pre-specified|Number of Participants Within the Categories of Increasing and Decreasing Blood Pressure and Pulse Measures:|Blood pressure is the force the heart exerts against the walls of arteries as it pumps the blood out to the body. The unit of measurement is millimeters of mercury (mm Hg). Pulse is the number of times your heart beats per minute. The unit of measurement is beats per minute (BPM). These test measurements compared in adults with moderate to severe plaque psoriasis week 16 after 16 weeks adalimumab and week 28 after 16 weeks adalimumab plus 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg vitamin B12.|Week 16 and Week 28|of 8 adults with moderate to severe plaque psoriasis, Seven participants were measured at week 16 after 16 weeks adalimumab and at week 28 after 16 weeks adalimumab then 12 weeks of adalimumab plus 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg B12. One who had SAE prior to Week 16 did not..||participants|||Number
670031|NCT01704599|Other Pre-specified|Number of Participants Within the Categories of Positive Urine Pregnancy Test (Urine Hcg)|Women of childbearing years over age 18 with moderate to severe plaque psoriasis on no systemic therapy at week 0 of study.|At screening|Only 1 of the 8 subjects was a woman of childbearing years during the study.||participant|||Number
670032|NCT01704599|Other Pre-specified|Number of Participants Within the Categories of Elevated and Normal Helicobacter Pylori Antibody|Adult participants age 18 years or older with moderate to severe plaque psoriasis with serum IgG antibodies against Helicobacter pylori bacteria using commercial ELISA assay during the 28 week study.|Week 28 after 16 weeks of Adalimumab then 12 of Adalimumab-Vitamins|8 adult participants with moderate to severe plaque psoriasis with H. pylori titers measured during the 28 week study.||participants|||Number
670033|NCT01704599|Secondary|Number of Participants With Category Change in Serum Folic Acid Level.|Serum folic acid level in adults ages 18 and older with mild to moderate plaque psoriasis measured at week 16 after 16 weeks adalimumab and at week 28 after 16 weeks adalimumab plus 12 weeks of adalimumab and daily 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg B12.|Weeks 16 and 28|8 particpantts with psoriasis. Five had folic acid levels drawn weeks 16 and 28. Three did not (one of the 3 had a SAE prior to week 16).||participants|||Number
670034|NCT01704599|Secondary|Number of Participants Within the Categories of Increasing and Decreasing Serum Vitamin B6 Level|Serum vitamin B6 levels were to be measured weeks16 after 16 weeks adalimumab and at week 28 after 16 weeks adalimumab and 12 weeks on adalimuamb, folic acid 5 mg, b6 100 mg and B12 1000 mcg in adult participants with moderate to sever plque psoriasis.|At Week 16 and Week 28|8 adults 18-65 with moderate to severe plaque psoriasis measured at weeks 16 and 28. .Four of 8 had levels drawn at weeks 16 and 28. Four did not. Of the four whoi did not one had a SAE prior to Week 16.||participants|||Number
670035|NCT01704599|Secondary|Number of Participants With Category Change in Vitamin B12 Blood Level|Adult participants 18 years or older with moderate to severe plaque psoriasis were to have serum B12 levels measures Weeks 0 (on no systemic psoriasis medication), 16 (on adalimumab) and week 28 (on adalimumab plus daily 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg B12.|At Week 16 and Week 28|8 adult participants ages 18-65 with moderate to severe plaque psoriasis. Five of 8 had B12 measured at weeks 16 and 28. Three did not. One of the 3 had SAE prior to week 16.||participants|||Number
670036|NCT01704599|Secondary|Number of Participants Within the Categories of Increasing and Decreasing Serum Homocysteine|Serum homocysteine measured at week 16 after 16 weeks of adalimumab and week 28 after 16 weeks of adalimumaband then 12 weeks of adalimumab plus 5 mg folic acid, 100mg B6 and 1000 mcg of B12 in adults ages 18-65 with moderate to sever plaque psoriasis..|Week 16 and Week 28|8 adults 18-65 with moderate to severe plaque psoriasis. 4 had levels measured at Week 16 and again at Week 28. Of the 4 not meausres 1 had a SAE prior to Week16.||participants|||Number
670037|NCT01704599|Other Pre-specified|Number of Participants Within the Categories of Increasing and Decreasing Serum Phosphorus|Serum phosphorus (P) levels were to be measured weeks16 and 28 in adult participants age 18 and older with moderate to severe plaque psoriasis at week 0 on no systemic psoriasis medication; week 16 after 16 weeks of adalimumab and at week 28 after 16 weeks of adalimumab plus 12 weeks of adalimumab plus 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg of B12.|Week 16 then Week 28|8 adults 18-65 years having moderate to severe plaque psoriasis. Five had levels measured at week 16 and and again at week 28 . Three did not . Of the 3 1 had SAE prior to week 16.||participants|||Number
670038|NCT01704599|Other Pre-specified|Number of Participants Within the Categories of Increasing and Decreasing Serum Magnesium|Serum magnesium (Mg) was to be measured at baseline, Week 16 (on adalimumab) and at week 28 (on adalimumab plus folic acid, vitamins B6 and B12) in adult participants age 18 or older with moderate to severe plaque psoriasis.|Weeks 16 and 28|8 Adults age 18-65 with moderate to severe plaque psoriasis.Five had results both weeks 16 and 28. Three did npot (of these 1 had SAE prior to week 16)||participants|||Number
670039|NCT01704599|Other Pre-specified|Number of Participants in Categories or Increasing and Decreasing Changes Within the CBC (Complete Blood Count)|Change in CBC parameter: white blood count or hemoglobin or hematocrit ( as measured week 16 on adalimumab and at week 28 after 12 more weeks on adalimuamb , folic acid, B6 and B12) in adults ages 18-65 with moderate to severe plaque psoriasis.|Week 16 and Week 28|8 adult participants with moderate to severe plaque psoriasis. Five had CBCs at both week 16 and week 28. three did not ( one of the 3 had a SAE pripor to week 16)||participants|||Number
670040|NCT01704599|Secondary|Number of Participants With Category Change in Serum VEGF (Vascular Endothelial Growth Factorl)|Adult particpants ages 18 or older with moderate to severe plaque psoriasis were to have serum VEGF measured at week 0 on no systemic psoriasis medication then at both weeks 16 on adalimumab and at week 28 on adalimumab plus folic acid, B6 and Vitamin B12. Subjects raniked by BMI week 0 low to high|At Screening visit, Week 16 on Humira, after another 12 weeks on Humira plus vitamins and if early termination|8 adult subjects age 18-65 with moderate to sefver plaque psoriasis. Five subjects had VEGF levels taken weeks 16 and 28. Three ( one wiht SAE prior to week 16) did not.||participants|||Number
670064|NCT01704495|Secondary|Change From Baseline to Treatment Period (Day 1 to Day 28) for Asthma Control Days||Baseline (last 14 days before randomization) and Treatment Period (Days 1 to 28)|Full Analysis set||asthma control days||90% Confidence Interval|Least Squares Mean
670065|NCT01704495|Secondary|Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Asthma Symptom Free Days||Baseline (last 14 days before randomization) and Treatment Period (Day 85 to 6 months)|Full Analysis set||symptom free days||90% Confidence Interval|Least Squares Mean
679159|NCT01587027|Primary|Adverse Events.|Adverse event data was evaluated for incidence and severity for 6 days.|6 days.|All enrolled participants were analyzed for adverse events.||Events|||Number
670041|NCT01704599|Other Pre-specified|Number of Participants in the Categories of Normalizing, Unchanging and Newly Abnormal Electrocardiograms (EKGs)|An electrocardiogram (EKG) is used to evaluate the electrical activity of the heart by converting this activity into line tracings on paper.. Electrodes (small, plastic patches) are placed at certain locations on the chest, arms, and legs. When the electrodes are connected to an EKG machine by lead wires, the electrical activity of the heart is measured, interpreted, and printed out for the doctor's information and further interpretation. This test was to be administered to adults age 18 or older with moderate to severe plaque psoriasis patients at week 0, 16 and week 28 of this study.|Week 16 and then Week 28 after another 12 weeks on Humira plus vitamins and if early termination|8 adults with moderate to severe plaque psoriasis. Seven evaluated at weeks 0,16 and 28 for no change in electrocardiogram (EKG) , worsening arrhymia or improvement of arrhythmia at weeks 16 and 28. Five of 8 studied weeks 0,16 and 28; 1 at week 16 and 28. Two (one with the SAE prior to Week 16) did not have EKGs both at weeks 16 and 28.||participants|||Number
670042|NCT01704599|Other Pre-specified|Number of Participants in the Categories of Having and of Not Having a Serious Adverse Event (SAE)|A serious adverse event is hosptalization or death or pathology leading to early termination of a participant from the study. This was to be reported at anytime during the 28 week study of adult patients ages 18-65 with moderate to severe plaque psoriasis though categorized by Week 16 (on adalimumab alone, by Week 28 (on adalimuamb plus 3 B vitaminsand by day 70 post Week 28.|By Week 16, by Week 28 and by Day 70 post Week 28.|Adults ages 18-65 with moderate to severe plaque psoriasis.||participants|||Number
670043|NCT01704599|Other Pre-specified|Number of Participants in the Categories of Having and Not Having an Adverse Event|"Worsening psoriasis or development or worsening of measured condition or new pathology not seen by week 16 but developed at weeks 28 or first discoved by telephone call day 70 post study:
AE Humira only"|After Week 16 of study|8 adult participants ages 18-65 with moderate to severe plaque psoriasis. Seven assessed after week 16 and at Week 28 of study and assessed at day 70 post week 28 visit ( the latter by telephone). One subject had SAE prior to vitamin addition.||participants|||Number
670044|NCT01704599|Secondary|Number of Participants With a Categorical DLQI (Dermatology Life Quality Index) Change|DLQI is 10 questions examining impact of skin disease on quality of life: (1) symptoms & feelings (2) daily activities (3) leisure (4) work & school (5) personal relationship (6) treatment. To be administered to adults over 18 years with moderate to severe plaque psoriasis at week 0 (no systemic psoriasis medication);. weeks 16 ( after 16 weeks of adalimumab) and week 28 (after 16 weeks adalimumab then 12 weeks of adalimumab plus daily 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg B12).|Week 16 and Week 28|8 adults with moderate to severe plaque psoriasis measured at weeks 16 and 28. Seven were measured weeks 16 and 28. One had SAE prior to week 16.||participants|||Number
670045|NCT01704599|Secondary|Number of Participants With a Categorical Change in Static Physician Global Assessment (sPGA):|Number of participants with a category change in Physician static Global Assessment (sPGA): 7 point score from 0 (clear) to 6 measuring amount of surface covered and plaque qualities: thickness & erythema plus scaling. Dynamic score compares baseline with either improvement/ worsening of the same factors measured in the sPGA using the 0-6 scoring range but focused on change. sPGA at weeks 16 AND 28. dynamic PGA to be categoically measured at.weeks16 and 28.|Week 16 and Week 28|8 adult participants with moderate to severe plaque psoriasis. 7 had static PGA scores weeks 16 and 28 and one had sPGA but SAE prior to week 16.||participants|||Number
670046|NCT01704521|Primary|Number of Participants With Sustained Virological Response at Week 12 (SVR12)|"Viral kinetic assessment using SVR 12 to either lead-in 4 weeks with PegInterferon + Ribavirin or no lead-in, followed by response guided therapy of 24 or 48 weeks based on viral response to treatment. Standard of care treatment stopping rules will be followed with assessment of viral response at week 12 of treatment."|Post-treatment at week 12|See baseline characteristics||participants|||Number
670047|NCT01704495|Secondary|Mean Plasma Concentration of AZD5069 at 1 Month||at 1 month|PK analysis set||(nmol/L)||Geometric Coefficient of Variation|Geometric Mean
670048|NCT01704495|Secondary|Mean Plasma Concentration of AZD5069 at Day 7||Day 7|PK analysis set||(nmol/L)||Geometric Coefficient of Variation|Geometric Mean
670049|NCT01704495|Secondary|Number of Uncontrolled Persistent Asthma Weeks During Treatment||Day 1 to end of the 6 months treatment period|Full analysis set||uncontrolled persistent asthma weeks||Standard Deviation|Mean
670050|NCT01704495|Secondary|Number of Participants With Uncontrolled Persistent Asthma Weeks at Baseline||Last 2 weeks before randomization|Full analysis set||participants|||Number
670051|NCT01704495|Secondary|Number of Well Controlled Asthma Weeks During Treatment||Day 1to end of the 6 months treatment period|Full Analysis set||well controlled asthma weeks||Standard Deviation|Mean
670052|NCT01704495|Secondary|Number of Participants With Well Controlled Asthma Weeks at Baseline||Last 2 weeks before randomization|||participants|||Number
670053|NCT01704495|Secondary|Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Night Time Awakenings Due to Asthma Symptoms||Baseline (last 14 days before randomization) and Treatment Period (Day 85 to 6 months)|Full analysis set||night time awakenings||90% Confidence Interval|Least Squares Mean
670054|NCT01704495|Secondary|Change From Baseline to Treatment Period (Day 57 to Day 84) for Night Time Awakenings Due to Asthma Symptoms||Baseline (last 14 days before randomization) and Treatment Period (Day 57 to Day 84)|full analysis set||night time awakenings||90% Confidence Interval|Least Squares Mean
670055|NCT01704495|Secondary|Change From Baseline to Treatment Period (Day 29 to Day 56) for Night Time Awakenings Due to Asthma Symptoms||Baseline (last 14 days before randomization) and Treatment Period (Day 29 to Day 56)|Full Analysis set||night time awakenings||90% Confidence Interval|Least Squares Mean
670056|NCT01704495|Secondary|Change From Baseline to Treatment Period (Day 1 to Day 28) for Night Time Awakenings Due to Asthma Symptoms||Baseline (last 14 days before randomization) and Treatment Period (Days 1 to 28)|Full analysis set||night time awakenings||90% Confidence Interval|Least Squares Mean
670057|NCT01704495|Secondary|Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Use of Rescue Medication Free Days||Baseline (last 14 days before randomization) and Treatment Period (Days 85 to 6 months)|Full Analysis set||rescue medication free days||90% Confidence Interval|Least Squares Mean
670058|NCT01704495|Secondary|Change From Baseline to Treatment Period (Day 57 to Day 84) for Use of Rescue Medication Free Days||Baseline (last 14 days before randomization) and Treatment Period (Days 57 to 84)|||rescue medication free days||90% Confidence Interval|Least Squares Mean
670067|NCT01704495|Secondary|Change From Baseline to Treatment Period (Day 29 to Day 56) for Astma Symptom Free Days||Baseline (last 14 days before randomization) and Treatment Period (Days 29 to 56)|Full Analysis set||symptom free days||90% Confidence Interval|Least Squares Mean
670068|NCT01704495|Secondary|Change From Baseline to Treatment Period (Day 1 to Day 28) for Astma Symptom Free Days||Baseline (last 14 days before randomization) and Treatment Period (Days 1 to 28)|Full Analysis set||Asthma symptom free days||90% Confidence Interval|Least Squares Mean
670069|NCT01704495|Secondary|Number of Patients Presenting Improvement From Baseline to End of Treatment Period in AQLQ(S) (Asthma Quality of Life Questionnaire Standardised Version) Overall Score|The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments in asthma. Patients are asked to score each item on a 7-point scale based on the experience of last 2 weeks. The overall AQLQ score is the mean response to all 32 questions. Therefore, the possible highest score (better) would be 7 and the lowest (worse) would be 1. Changes in scores of 0.5 to 1.0 are considered clinically meaningful; 1.0 to 1.5 as moderate and > 1.5 as marked clinically important differences for any individual domain or for the overall summary score.|Baseline (Day 0) and 6 months after Day 0|Full Analysis set||Participants with improvement|||Number
670070|NCT01704495|Secondary|Change From Baseline to Overall Mean of Treatment Period in AQLQ(S) (Asthma Quality of Life Questionnaire Standardised Version) Overall Score|The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments in asthma. Patients are asked to score each item on a 7-point scale based on the experience of last 2 weeks. The overall AQLQ score is the mean response to all 32 questions. Therefore, the possible highest score (better) would be 7 and the lowest (worse) would be 1. Changes in scores of 0.5 to 1.0 are considered clinically meaningful; 1.0 to 1.5 as moderate and > 1.5 as marked clinically important differences for any individual domain or for the overall summary score.|Baseline (Day 0), Treatment Period (1,3, and 6 months)|||Overall Score||90% Confidence Interval|Least Squares Mean
670071|NCT01704495|Secondary|Number of Patients Presenting Improvement From Baseline to End of Treatment Period in ACQ-5 (Asthma Control Questionnaire, 5-item Version)|The ACQ-5 is a validated questionnaire consisting of 5 items for the assessment of asthma symptom which are night symptom, morning symptom, limitation for the activities, shortness of breath, and wheeze. Each item is graded on a scale of 0-6 and the questions are equally weighted. The ACQ-5 score is the mean of the 5 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled).|Baseline (Day 0) and 6 months after Day 0|Full Analysis set||Participants with improvement|||Number
670072|NCT01704495|Secondary|Change From Baseline to Overall Mean of Treatment Period in ACQ-5 (Asthma Control Questionnaire, 5-item Version) Total Score|The ACQ-5 is a validated questionnaire consisting of 5 items for the assessment of asthma symptom which are night symptom, morning symptom, limitation for the activities, shortness of breath, and wheeze. Each item is graded on a scale of 0-6 and the questions are equally weighted. The ACQ-5 score is the mean of the 5 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled).|Baseline (Day 0), Treatment Period (1,2,3,4, and 6 months)|Full Analysis set||Units on a scale]||90% Confidence Interval|Least Squares Mean
670073|NCT01704495|Secondary|Change From Baseline to 6 Months Measurement of Post-bronchodilator FEV1|Only patients with both a non-missing value at baseline and visit at six months are included in the analysis|Baseline (Day 0) and 6 months after Day 0|Full Analysis set||L||90% Confidence Interval|Least Squares Mean
670074|NCT01704495|Secondary|Change From Baseline to 4 Months Measurement of Post-bronchodilator FEV1|Only patients with both a non-missing value at baseline and visit at four months are included in the analysis|Baseline (Day 0) and 4 months after Day 0|Full Analysis set||L||90% Confidence Interval|Least Squares Mean
670075|NCT01704495|Secondary|Change From Baseline to 3 Months Measurement of Post-bronchodilator FEV1|Only patients with both a non-missing value at baseline and visit at three months are included in the analysis|Baseline (Day 0) and 3 months after Day 0|Full Analysis set||L||90% Confidence Interval|Least Squares Mean
670076|NCT01704495|Secondary|Change From Baseline to 2 Months Measurement of Post-bronchodilator FEV1|Only patients with both a non-missing value at baseline and visit at two months are included in the analysis|Baseline (Day 0) and 2 months after Day 0|Full Analysis set||L||90% Confidence Interval|Least Squares Mean
670077|NCT01704495|Secondary|Change From Baseline to 1 Month Measurement of Post-bronchodilator FEV1|Only patients with both a non-missing value at baseline and visit at one month are included in the analysis|Baseline (Day 0) and 1 month after Day 0|Full Analysis set||L||90% Confidence Interval|Least Squares Mean
670078|NCT01704495|Secondary|Change From Baseline to 2 Weeks Measurement of Post-bronchodilator FEV1|Only patients with both a non-missing value at baseline and visit at two weeks are included in the analysis|Baseline (Day 0) and 2 weeks after Day 0|||L||90% Confidence Interval|Least Squares Mean
670079|NCT01704495|Secondary|Change From Baseline to 6 Months Measurement of Pre-bronchodilator FEV1|Only patients with both a non-missing value at baseline and visit at six months are included in the analysis|Baseline (Day 0) and 6 months after Day 0|Full Analysis set||L||90% Confidence Interval|Least Squares Mean
670080|NCT01704495|Secondary|Change From Baseline to 4 Months Measurement of Pre-bronchodilator FEV1|Only patients with both a non-missing value at baseline and visit at four months are included in the analysis|Baseline (Day 0) and 4 months after Day 0|Full analysis set||L||90% Confidence Interval|Least Squares Mean
670081|NCT01704495|Secondary|Change From Baseline to 3 Months Measurement of Pre-bronchodilator FEV1|Only patients with both a non-missing value at baseline and visit at three months are included in the analysis|Baseline (Day 0) and 3 months after Day 0|Full analysis set||L||90% Confidence Interval|Least Squares Mean
670082|NCT01704495|Secondary|Change From Baseline to 2 Months Measurement of Pre-bronchodilator FEV1|Only patients with both a non-missing value at baseline and visit at two months are included in the analysis|Baseline (Day 0) and 2 months after Day 0|Full analysis set||L||90% Confidence Interval|Least Squares Mean
670083|NCT01704495|Secondary|Change From Baseline to 1 Month Measurement of Pre-bronchodilator FEV1|Only patients with both a non-missing value at baseline and visit at one month are included in the analysis|Baseline (Day 0) and 1 month after Day 0|||L||95% Confidence Interval|Least Squares Mean
670084|NCT01704495|Secondary|Change From Baseline to 2 Weeks Measurement of Pre-bronchodilator FEV1|Only patients with both a non-missing value at baseline and visit at two weeks are included in the analysis|Baseline (Day 0) and 2 weeks after Day 0|Full analysis set||L||90% Confidence Interval|Least Squares Mean
670089|NCT01704404|Other Pre-specified|Plasma Half-life|"Day 1: 15 minutes pre-dose, post-dose at 15 and 30 minutes, 1, 2, 3, 4, and 6 hours.
Day 7: 15 minutes pre-dose, post-dose at 15 and 30 minutes, 1, 2, 3, 4, 6, 8, 12 and 24 hours."|From baseline to day 7|The number of subjects reported for plasma half lives are based on the actual evaluable PK data.||hours||Standard Deviation|Mean
670090|NCT01704404|Other Pre-specified|Tmax|"Day 1: 15 minutes pre-dose, post-dose at 15 and 30 minutes, 1, 2, 3, 4, and 6 hours.
Day 7: 15 minutes pre-dose, post-dose at 15 and 30 minutes, 1, 2, 3, 4, 6, 8, 12 and 24 hours."|From baseline to day 7|||hours||Standard Deviation|Mean
670091|NCT01704404|Other Pre-specified|Cmax|"Day 1: 15 minutes pre-dose, post-dose at 15 and 30 minutes, 1, 2, 3, 4, and 6 hours.
Day 7: 15 minutes pre-dose, post-dose at 15 and 30 minutes, 1, 2, 3, 4, 6, 8, 12 and 24 hours."|From baseline to day 7|||ng/mL||Standard Deviation|Mean
670092|NCT01704404|Primary|Change From Baseline to Day 7 in Trough FEV1 (Forced Expiratory Volume in 1 Second)||From baseline to day 7|||FEV1 (mL)||Standard Error|Mean
670093|NCT01704287|Secondary|Number of Participants Who Discontinued Study Drug Due to an AE|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of study drug, is also an AE.|Up to approximately 33 months|The Safety Population consisted of all participants who received at least one dose of study drug.||Participants|||Number
670094|NCT01704287|Secondary|Number of Participants Who Experienced an Adverse Event (AE)|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of study drug, is also an AE.|Up to approximately 36 months|The Safety Population consisted of all participants who received at least one dose of study drug.||Participants|||Number
670095|NCT01704287|Secondary|Duration of Response (DOR)|For participants who demonstrated a confirmed response (CR or PR) per RECIST 1.1, response duration was defined as the time from first documented evidence of CR or PR until disease progression or death. Response duration for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. DOR analysis was based on IRO assessment. DOR was not analyzed for the crossover populations.|Up to approximately 33 months|Among participants who demonstrated a confirmed response (CR or PR), the population consisted of all randomized participants who had measurable disease at baseline and who demonstrated a confirmed CR or PR per RECIST 1.1. Participants were included in the treatment group to which they were randomized for the efficacy analysis.||Months||Full Range|Median
670096|NCT01704287|Secondary|Best Overall Response Among Participants Receiving ICC Who Switched to Receiving Pembrolizumab|The best overall response was assessed by independent radiology review using RECIST 1.1 and was recorded from the start of the second line of study treatment until the end of treatment. Response categories included: Complete Response (CR): disappearance of all target lesions; Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions; Progressive Disease (PD): at least a 20% increase in the sum of diameters of target lesions; and Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Best overall response was based based on independent review committee (IRC) for the crossover populations.|Up to approximately 29 months|The ITT Population consisted of all randomized participants who had measurable disease at baseline. Participants were included in the treatment group to which they were randomized for the efficacy analysis.||Percentage of Participants|||Number
670097|NCT01704287|Secondary|Best Overall Response - Initial Treatment Period|The best overall response was assessed by independent radiology review using RECIST 1.1 and was recorded from the start of the study treatment until the end of treatment. Response categories included: Complete Response (CR): disappearance of all target lesions; Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions; Progressive Disease (PD): at least a 20% increase in the sum of diameters of target lesions; and Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Best overall response for the Initial Treatment Period was based on IRO.|Up to approximately 33 months|The ITT Population consisted of all randomized participants who had measurable disease at baseline. Participants were included in the initial treatment group to which they were randomized for the efficacy analysis.||Percentage of Participants|||Number
670098|NCT01704287|Primary|Overall Survival (OS)|OS was defined as the time from randomization to death due to any cause. OS was not analyzed for the crossover populations.|Up to approximately 33 months|The ITT Population consisted of all randomized participants who had measurable disease at baseline. Participants were included in the treatment group to which they were randomized for the efficacy analysis.||Months||95% Confidence Interval|Median
670099|NCT01704287|Primary|Progression-free Survival (PFS)|PFS was defined as the time from randomization to the first documented disease progression, or death due to any cause, whichever occurred first. Per Response Criteria in Solid Tumors version 1.1 (RECIST 1.1), progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered progression. PFS analysis was based on an integrated radiology and oncology (IRO) assessment. PFS was not analyzed for the crossover populations.|Up to approximately 33 months|The Intent-to-Treat (ITT) Population consisted of all randomized participants who had measurable disease at baseline. Participants were included in the treatment group to which they were randomized for the efficacy analysis.||Months||95% Confidence Interval|Median
670100|NCT01704261|Secondary|Percentage of Participants Attaining A1C Glycemic Goals of <7% and <6.5% at Week 24|The percentage of participants who achieved A1C values <6.5% (48 mmol/mol) or <7.0% (53 mmol/mol) in the FAS population at Week 24.|24 weeks|The FAS Population consisted of all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a measurement for the analysis endpoint after receiving study medication. One participant was in 2 clinical trials in parallel and was excluded from all efficacy and safety analysis.||Percentage of participants||95% Confidence Interval|Number
670101|NCT01704261|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Blood glucose was measured on a fasting basis. FPG is expressed as mg/dL. Blood was drawn at predose on Day 1 and after 24 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 24 minus FPG at baseline).|Baseline and Week 24|The FAS population consisted of all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a measurement for the analysis endpoint after receiving study medication. One participant was in 2 clinical trials in parallel and was excluded from all efficacy and safety analysis.||mg/dL||95% Confidence Interval|Least Squares Mean
670102|NCT01704261|Primary|Percentage of Participants Who Discontinued From the Study Due to an AE|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.|Up to Week 24|The ASaT Population was defined as all randomized participants who received at least 1 dose of study medication. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant was in 2 clinical trials and was excluded from all efficacy and safety analysis.||Percentage of participants|||Number
670103|NCT01704261|Primary|Percentage of Participants Who Experienced at Least One Adverse Event (AE)|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.|Up to Week 27|All Subjects as Treated (ASaT) population, defined as all randomized participants who received at least 1 dose of study medication. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant was in 2 clinical trials and was excluded from all efficacy and safety analysis.||Percentage of participants|||Number
670104|NCT01704261|Primary|Change From Baseline in Hemoglobin A1c (A1C) at Week 24|A1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%). Thus, this change from baseline reflects the Week 24 A1C minus the Week 0 A1C.|Baseline and Week 24|The Full Analysis Set (FAS) population consisted of all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a measurement for the analysis endpoint after receiving study medication. One participant was in 2 clinical trials in parallel and was excluded from all efficacy and safety analysis.||%A1C||95% Confidence Interval|Least Squares Mean
670105|NCT01704196|Secondary|Reduction in Use (Weeks 1 - 11)|Proportion of Subjects with a 50% or More Reduction in Cocaine Use from Baseline through week 11|Baseline through week 11|||participants|||Number
670106|NCT01704196|Primary|Abstinence (Weeks 10 - 11)|Number of subjects that abstained from cocaine from weeks 10 through 11|Weeks 10 - 11|||Participants|||Count of Participants
670107|NCT01704079|Secondary|Subjects in the Per Protocol Population With Normal Serum Total 25-hydroxyvitamin D|Subjects in the per protocol population with normal serum total 25-hydroxyvitamin D (>/= 30 ng/mL)|Approximately 6 months|Per protocol||participants|||Number
670108|NCT01704079|Secondary|Subjects in the Intent to Treat Population With Normal Serum Total 25-hydroxyvitamin D|Subjects in the intent to treat population with normal serum total 25-hydroxyvitamin D (>/= 30 ng/dL)|Approximately 6 months|Intent to treat||participants|||Number
670109|NCT01704079|Secondary|Number of Participants in the Per Protocol Population With Decrease in Plasma Intact Parathyroid Hormone (iPTH) of ≥30% From Pre-treatment Baseline|Number of subjects in the per protocol population attaining a mean decrease in plasma intact parathyroid hormone (iPTH) of ≥30% from pre-treatment baseline in the efficacy assessment phase (EAP), referred to as responders|Approximately 6 months|Per protocol||participants|||Number
670110|NCT01704079|Primary|Number of Participants in the Intent to Treat Population With Decrease in Plasma Intact Parathyroid Hormone (iPTH) of ≥30% From Pre-treatment Baseline|Number of subjects in the intent to treat population attaining mean decrease in plasma intact Parathyroid Hormone (iPTH) of ≥30% from P\pre-treatment baseline in the efficacy assessment phase (EAP) referred to as responders|Approximately 6 months|Intent to treat||participants|||Number
670111|NCT01703988|Secondary|Urine Pharmacokinetics: Renal Clearance, Cohort 4|Renal clearance of nusinersen for participants was assessed in the 12 mg reporting group only, per protocol.|Day 1 and Day 85|Pharmacokinetic (PK) Population, defined as all enrolled participants who have evaluable PK data||mL/hr||Standard Deviation|Mean
670112|NCT01703988|Secondary|Cerebrospinal Fluid (CSF) Pharmacokinetics: Predose CSF Drug Concentrations||Day 1, Day 29, and Day 85|PK Population, defined as all enrolled participants who have evaluable PK data; number analyzed=participants with an assessment at given time point. (This study includes participants previously enrolled in Study ISIS 396443 - CS1 (NCT01494701).||ng/mL||Standard Deviation|Mean
670113|NCT01703988|Secondary|Plasma Pharmacokinetics: Plasma Pharmacokinetics: Area Under the Plasma Concentration Time Curve From the Time of the IT Dose to 6 Hours After Dosing (AUC0-6hr)||Day 1 and Day 85|PK Population, defined as all enrolled participants who have evaluable PK data; number analyzed=participants with an assessment at given time point.||ng*hr/mL||Standard Deviation|Mean
670114|NCT01703988|Secondary|Plasma Pharmacokinetics: Time to Reach Cmax in Plasma||Day 1 and Day 85|PK Population, defined as all enrolled participants who have evaluable PK data; number analyzed=participants with an assessment at given time point.||hours||Full Range|Median
670115|NCT01703988|Secondary|Plasma Pharmacokinetics: Maximal Observed Plasma Drug Concentration (Cmax)||Day 1 and Day 85|Pharmacokinetic (PK) Population, defined as all enrolled participants who have evaluable PK data; number analyzed=participants with an assessment at given time point.||ng/mL||Standard Deviation|Mean
670127|NCT01703845|Primary|Cmax,ss (Tiotropium)|"Maximum measured concentration of tiotropium after multiple inhaled administration of tiotropium+olodaterol in plasma at steady state (Cmax,ss).
Per Protocol there are no primary endpoints defined. Therefore this pharmacokinetic endpoint was selected for primary outcome measure type."|15 minutes (min) pre-dose and 5, 10, 20, 40 min, 1, 2, 3, and 4 hours (h) following drug administration on day 21|The Pharmacokinetic (PK) set.||picogram/milliliter (pg/mL)||Geometric Coefficient of Variation|Geometric Mean
670128|NCT01703845|Secondary|Number of Participants With Adverse Events (Including Assessment Based on Physical Examination)|Outcome data show are the number of patients with an adverse event including the assessment based on physical examination.|up to 6 weeks (3 weeks treatment and 3 weeks follow-up) post dose|Treated Set (TS) includes all randomised patients who received at least one dose of trial medication.||participants|||Number
670116|NCT01703988|Primary|Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Discontinuations Due to AEs, and Highest Severity of AEs|An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the study or use of the investigational drug product, whether or not the AE is considered related to the investigational drug product. An SAE is any AE that, in the view of either the Investigator or Sponsor, meets any of the following criteria: results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; results in congenital anomaly or birth defect; and is an important medical event in the judgment of the investigator. Drug-related is an event related or possibly related to study drug. Severity of AEs was assessed as mild, moderate, or severe.|Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days|Safety Population, defined as all enrolled participants who received at least 1 dose of study drug.||Participants|||Count of Participants
670117|NCT01703858|Secondary|Area Under the Concentration-time Curve of the Analyte BI-113608 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity)|Area under the concentration-time curve of the analyte BI-113608 in plasma over the time interval from 0 extrapolated to infinity (AUC 0-infinity).|PK plasma samples were taken at: 2 hours (h) before drug administration and 15 min, 30 min, 45 min, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 14h, 24h, 48h, 72h after drug administration.|Pharmacokinetic (PK) set: It included all treated subjects who provided at least 1 observation for at least 1 primary PK endpoint without important protocol violations relevant to the evaluation of PK.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
670118|NCT01703858|Primary|Maximum Measured Concentration of the Analyte BI-113608 in Plasma (Cmax)|Maximum measured concentration of the analyte BI-113608 in plasma (Cmax).|PK plasma samples were taken at: 2 hours (h) before drug administration and 15 min, 30 min, 45 min, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 14h, 24h, 48h, 72h after drug administration.|Pharmacokinetic (PK) set: It included all treated subjects who provided at least 1 observation for at least 1 primary PK endpoint without important protocol violations relevant to the evaluation of PK.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
670119|NCT01703858|Primary|Area Under the Concentration-time Curve of the Analyte BI-113608 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)|Area under the concentration-time curve of the analyte BI-113608 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz).|PK plasma samples were taken at: 2 hours (h) before drug administration and 15 min, 30 min, 45 min, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 14h, 24h, 48h, 72h after drug administration.|Pharmacokinetic (PK) set: It included all treated subjects who provided at least 1 observation for at least 1 primary PK endpoint without important protocol violations relevant to the evaluation of PK.||nanomol (nmol)* hours (h) / Litre (L)||Geometric Coefficient of Variation|Geometric Mean
670120|NCT01703845|Secondary|Number of Participants With Clinically Relevant Abnormalities in Vital Signs, Clinical Laboratory Tests and ECG|"Outcome data show are the number of participants with clinically relevant abnormalities reported as an adverse event (AE) related to the vital signs (pulse rate and blood pressure in supine position), clinical laboratory (routine blood chemistry, haematology, and urinalysis) tests and ECG (12-lead holter monitoring Electrocardiography). Relevant findings or worsening of baseline conditions were reported as adverse events.
There were no clinically relevant abnormalities reported as an AE related to the vital signs and ECG."|up to 6 weeks (3 weeks treatment and 3 weeks follow-up) post dose|The treated Set (TS).||participants|||Number
670121|NCT01703845|Primary|CLR,t1-t2,ss (Tiotropium)|"Renal clearance from the time point t1 (0 h) until the time point t2 (4 h) at steady state (CLR,t1-t2,ss).
Per Protocol there are no primary endpoints defined. Therefore this pharmacokinetic endpoint was selected for primary outcome measure type.
Plasma concentration of tiotropium could not be quantified up to 4 hours for Tiotropium + Olodaterol (2.5μg/5μg)."|from 0 to 4 hours following drug administration on day 21|The Pharmacokinetic (PK) set.||mL/min||Geometric Coefficient of Variation|Geometric Mean
670122|NCT01703845|Primary|fe t1-t2,ss (Tiotropium)|"Fraction eliminated in urine from the time point t1 (0 h) to time point t2 (4 h) at steady state (fet1-t2,ss).
Per Protocol there are no primary endpoints defined. Therefore this pharmacokinetic endpoint was selected for primary outcome measure type."|from 0 to 4 hours following drug administration on day 21|The Pharmacokinetic (PK) set.||percentage of dose||Geometric Coefficient of Variation|Geometric Mean
670123|NCT01703845|Primary|Aet1-t2,ss (Tiotropium)|"Amount of tiotropium that is eliminated in urine after multiple inhaled administration of tiotropium+olodaterol over the time interval 0 to 4 hours at steady state (Aet1-t2,ss).
Per Protocol there are no primary endpoints defined. Therefore this pharmacokinetic endpoint was selected for primary outcome measure type."|from 0 to 4 hours following drug administration on day 21|The Pharmacokinetic (PK) set.||nanogram (ng)||Geometric Coefficient of Variation|Geometric Mean
670124|NCT01703845|Primary|Tmax,ss (Tiotropium)|"Time from dosing to the maximum concentration of tiotropium after multiple inhaled administration of tiotropium+olodaterol in plasma at steady state (tmax,ss).
Per Protocol there are no primary endpoints defined. Therefore this pharmacokinetic endpoint was selected for primary outcome measure type."|15 min pre-dose and 5, 10, 20, 40 min, 1, 2, 3, 4 hours following drug administration on day 21|The Pharmacokinetic (PK) set.||h||Full Range|Median
670125|NCT01703845|Primary|AUC0-tz,ss (Tiotropium)|"Area under the concentration-time curve of tiotropium after multiple inhaled administration of tiotropium+olodaterol in plasma over the time interval from 0 to the time of the last quantifiable data point at steady state (AUC0-tz,ss).
Per Protocol there are no primary endpoints defined. Therefore this pharmacokinetic endpoint was selected for primary outcome measure type."|15 min pre-dose and 5, 10, 20, 40 min, 1, 2, 3, and 4 h following drug administration on day 21|The Pharmacokinetic (PK) set.||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
670126|NCT01703845|Primary|AUCt1-t2,ss (Tiotropium)|"Area under the concentration-time curve of tiotropium in plasma after multiple inhaled administration of tiotropium+olodaterol over the time interval 0 to 2 hours at steady state (AUCt1-t2,ss).
Per Protocol there are no primary endpoints defined. Therefore this pharmacokinetic endpoint was selected for primary outcome measure type."|15 min pre-dose and 5, 10, 20, 40 min, 1 and 2 h following drug administration on day 21|The Pharmacokinetic (PK) set.||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
670129|NCT01703845|Primary|CLR,t1-t2,ss (Olodaterol)|"Renal clearance from the time point t1 (0 h) until the time point t2 (4 h) at steady state (CLR,t1-t2,ss).
Per Protocol there are no primary endpoints defined. Therefore this pharmacokinetic endpoint was selected for primary outcome measure type."|from 0 to 4 hours following drug administration on day 21|The Pharmacokinetic (PK) set.||mL/min||Geometric Coefficient of Variation|Geometric Mean
670130|NCT01703845|Primary|fe t1-t2,ss (Olodaterol)|"Fraction eliminated in urine from the time point t1 (0 h) to time point t2 (4 h) at steady state (fet1-t2,ss).
Per Protocol there are no primary endpoints defined. Therefore this pharmacokinetic endpoint was selected for primary outcome measure type."|from 0 to 4 hours following drug administration on day 21|The Pharmacokinetic (PK) set.||percentage of dose||Geometric Coefficient of Variation|Geometric Mean
670131|NCT01703845|Primary|Aet1-t2,ss (Olodaterol)|"Amount of olodaterol that is eliminated in urine after multiple inhaled administration of tiotropium+olodaterol over the time interval 0 to 4 hours at steady state (Aet1-t2,ss).
Per Protocol there are no primary endpoints defined. Therefore this pharmacokinetic endpoint was selected for primary outcome measure type."|from 0 to 4 hours following drug administration on day 21|The Pharmacokinetic (PK) set.||nanogram (ng)||Geometric Coefficient of Variation|Geometric Mean
670132|NCT01703845|Primary|Tmax,ss (Olodaterol)|"Time from dosing to the maximum concentration of Olodaterol after multiple inhaled administration of tiotropium+olodaterol in plasma at steady state (tmax,ss).
Per Protocol there are no primary endpoints defined. Therefore this pharmacokinetic endpoint was selected for primary outcome measure type."|15 min pre-dose and 5, 10, 20, 40 min, 1, 2, 3 and 4 hours (h) following drug administration on day 21|The Pharmacokinetic (PK) set.||h||Full Range|Median
670133|NCT01703845|Primary|AUC0-tz,ss (Olodaterol)|"Area under the concentration-time curve of olodaterol after multiple inhaled administration of tiotropium+olodaterol in plasma over the time interval from 0 to the time of the last quantifiable data point at steady state (AUC0-tz,ss).
Per Protocol there are no primary endpoints defined. Therefore this pharmacokinetic endpoint was selected for primary outcome measure type."|15 min pre-dose and 5, 10, 20, 40 min, 1, 2, 3, and 4 h following drug administration on day 21|The Pharmacokinetic (PK) set.||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
670134|NCT01703845|Primary|AUCt1-t2,ss (Olodaterol)|"Area under the concentration-time curve of olodaterol in plasma after multiple inhaled administration of tiotropium+olodaterol over the time interval 0 to 4 hours at steady state (AUCt1-t2,ss).
Per Protocol there are no primary endpoints defined. Therefore this pharmacokinetic endpoint was selected for primary outcome measure type."|15 min pre-dose and 5, 10, 20, 40 min, 1, 2, 3, and 4 h following drug administration on day 21|The Pharmacokinetic (PK) set.||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
670135|NCT01703845|Primary|Cmax,ss (Olodaterol)|"Maximum measured concentration of olodaterol after multiple inhaled administration of tiotropium+olodaterol in plasma at steady state (Cmax,ss).
Per Protocol there are no primary endpoints defined. Therefore this pharmacokinetic endpoint was selected for primary outcome measure type."|15 minutes (min) pre-dose and 5, 10, 20, 40 min, 1, 2, 3, and 4 hours (h) following drug administration on day 21|The Pharmacokinetic (PK) set was defined as all treated patients who have at least 1 PK parameter in the treatment period without PK related important protocol violations. Two patients prematurely stopped the trial medication and had no PK measurement at Visit 3 (day 21) and were excluded from the PK set. Thus, the PK set included 30 patients.||picogram/milliliter (pg/mL)||Geometric Coefficient of Variation|Geometric Mean
670136|NCT01703832|Secondary|Psychological Questionnaire (Modified Somatic SCL90)|"The SCL90 has 90 items with dimensions like depression, somatization, obsessive-compulsive disorder, social insecurity, anxiety, phobic anxiety, aggression/hostility, paranoid ideation, psychoticism and each item in a subscale ranged from 0 to 4. The lower range values are favorable outcomes and higher are worse outcomes. The modified somatic SCL90 uses the SCL90 somatization items, but instead of a 7 day timeframe asks for now. The corresponding items from SCL90 were: 1, 4, 12, 27, 40, 42, 48, 49, 52, 53, 56, 58 and the introductory question: “How much do you currently suffer from” (Wie sehr leiden Sie momentan unter:). The median of the average Modified Somatic SCL90 score is reported. The average score was calculated at each time point as the sum score divided by the number of non-missing individual question results for subjects with no more than 2 missing responses. The lower values in the range represent favorable outcomes while the higher values represent worse outcomes."|-210 minutes, +100 minutes|33 participants were randomized to Neurexan and 32 participants to Natural Course and all randomized participants were included in the Safety Set. 32 Neurexan and 32 Natural Course participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy.||units on a scale||Full Range|Median
670137|NCT01703832|Secondary|State Anxiety and Stress Perception Measured by STAI-X1|"State anxiety and stress perception were measured by State-Trait Anxiety Inventory X1 before and after a stress test. The measurements took place 90 minutes before stress test and were repeated 15 and 100 minutes after the end of the stress test. The German version of the State-Trait-Anxiety Inventory was used and differentiates between temporary/emotional state anxiety versus personality trait anxiety. The two scales with 20 items each assess (1) anxiety as a trait (STAI-X2) and (2) anxiety as a state (STAI-XI). Answers are given in a 4-point rating scale ranging from 1 =not at all to 4 =very true. For analysis of each, STAI-scale single scores were summed up to one total score, representing the state and trait anxiety. Score range is 20-80 and higher scores indicate a higher anxiety."|-90 minutes, +15 minutes, +100 minutes|33 participants were randomized to Neurexan and 32 participants to Natural Course and all randomized participants were included in the Safety Set. 32 Neurexan and 32 Natural Course participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy.||units on a scale||Full Range|Median
670138|NCT01703832|Secondary|Changes in Heart Rate|"Blood pressure and heart rate were measured before and after a stress test by continuous cardiovascular recording.
The measurements started 30 minutes before stress test and were repeated until 45 minutes after the end of the stress test."|-15 minutes, 0 minutes, +15 minutes, +45 minutes|33 participants were randomized to Neurexan and 32 participants to Natural Course and all randomized participants were included in the Safety Set. 32 Neurexan and 32 Natural Course participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy.||beats per minute||Full Range|Median
670168|NCT01703741|Secondary|Percentage of Subjects With a Serum Total Testosterone Level of 1500-1799, 1800-2499, or Above 2500 ng/dL|The data were presented using descriptive statistics.|At Month 3|PP analysis population was used which comprises data from subjects who had 24 hr PK data for testosterone, with no major protocol violations.||percentage of subjects|||Number
670139|NCT01703832|Secondary|Changes in Blood Pressure|"Blood pressure and heart rate were measured before and after a stress test by continuous cardiovascular recording.
The measurements started 30 minutes before stress test and were repeated until 45 minutes after the end of the stress test."|-15 minutes, 0 minutes, +15 minutes, +45 minutes|33 participants were randomized to Neurexan and 32 participants to Natural Course and all randomized participants were included in the Safety Set. 32 Neurexan and 32 Natural Course participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy.||mmHg||Full Range|Median
670140|NCT01703832|Secondary|Changes in Natural Killer (NK) Cells (Subgroup)|The Natural Killer Cells as immune cells and stress biomarkers were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test.|-60 minutes, +15 minutes, +45 minutes, +100 minutes|The test was only conducted in the Essen site where 15 participants randomized to Neurexan and 12 participants randomized to Natural Course could be evaluated for NK cells||percentage of lymphocytes||Full Range|Median
670141|NCT01703832|Secondary|Changes in Plasma Catecholamines (Norepinephrine)|The stress biomarkers plasma and saliva cortisol and alpha amylase and Adrenocorticotropic Hormone and catecholamines (norepinephrine and epinephrine) were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test.|-60 minutes, +15 minutes, +45 minutes, +100 minutes|33 participants were randomized to Neurexan and 32 participants to Natural Course and all randomized participants were included in the Safety Set. For plasma Norepinephrine evaluation 30 Neurexan and 23 Natural Course participants were evaluated due to insufficient sample.||ng/L||Full Range|Median
670142|NCT01703832|Secondary|Changes in Plasma Catecholamines (Epinephrine)|The stress biomarkers plasma and saliva cortisol and alpha amylase and Adrenocorticotropic Hormone and catecholamines (norepinephrine and epinephrine) were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test.|-60 minutes, +15 minutes, +45 minutes, +100 minutes|33 participants were randomized to Neurexan and 32 participants to Natural Course and all randomized participants were included in the Safety Set. For plasma Epinephrine evaluation 30 Neurexan and 23 Natural Course participants were evaluated due to insufficient sample.||ng/L||Full Range|Median
670143|NCT01703832|Secondary|Changes in Plasma Cortisol|The stress biomarkers plasma and saliva cortisol and alpha amylase and Adrenocorticotropic Hormone and catecholamines (norepinephrine and epinephrine) were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test.|-60 minutes, +15 minutes, +45 minutes, +100 minutes|33 participants were randomized to Neurexan and 32 participants to Natural Course and all randomized participants were included in the Safety Set. For the plasma Cortisol evaluation 31 Neurexan and 24 Natural Course participants were evaluated due to insufficient sample.||nmol/L||Full Range|Median
670144|NCT01703832|Secondary|Changes in Plasma Adrenocorticotropic Hormone (ACTH)|The stress biomarkers plasma and saliva cortisol and alpha amylase and Adrenocorticotropic Hormone and catecholamines (norepinephrine and epinephrine) were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test.|-60 minutes, +15 minutes, +45 minutes, +100 minutes|33 participants were randomized to Neurexan and 32 to Natural Course and all randomized participants were included in the Safety Set. For plasma ACTH evaluation 31 Neurexan and 24 Natural Course participants were evaluated due to insufficient samples and the -60 min time-point had 30 evaluable Neurexan participants.||ng/L||Full Range|Median
670145|NCT01703832|Secondary|Changes in Saliva Cortisol|The stress biomarkers plasma and saliva cortisol and alpha amylase and Adrenocorticotropic Hormone and catecholamines (norepinephrine and epinephrine) were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test.|-60 minutes, +15 minutes, +45 minutes, +100 minutes|33 participants were randomized to Neurexan and 32 participants to Natural Course and all randomized participants were included in the Safety Set. 32 Neurexan and 32 Natural Course participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy.||nmol/mL||Full Range|Median
670146|NCT01703832|Secondary|Changes in Saliva Alpha Amylase|The stress biomarkers plasma and saliva cortisol and alpha amylase and Adrenocorticotropic Hormone and catecholamines (norepinephrine and epinephrine) were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test.|-60 minute, +15 minute , + 45 minute, +100 minute|33 participants were randomized to Neurexan and 32 participants to Natural Course and all randomized participants were included in the Safety Set. 32 Neurexan and 32 Natural Course participants that could be evaluated for primary efficacy formed the Full Analysis Set for efficacy. Note: -60 minute time-point had 31 evaluable Neurexan participants.||IU/mL||Full Range|Median
670147|NCT01703832|Primary|Acute Stress Measured by Nervousness|"Tension and nervousness were self-assessed by the participants on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) before and after a stress test. The VAS is used to determine the subjective impression of tension and nervousness on a 10 cm bipolar visual scale ranging from 0 = not at all to 100 = highly. The measurements started with first intake of Neurexan or Natural Course and were repeated until 100 minutes after the end of the stress test. The total stress was then summarized with the Area under the curve (AUC) method."|-210 minutes to +100 minutes|33 participants were randomized to Neurexan and 32 participants to Natural Course and all randomized participants were included in the Safety Set. 32 Neurexan and 32 Natural Course participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy.||mm*min||Full Range|Median
670148|NCT01703832|Primary|Acute Stress Measured by Tension|"Tension and nervousness were self-assessed by the participants on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) before and after a stress test. The VAS is used to determine the subjective impression of tension and nervousness on a 10 cm bipolar visual scale ranging from 0 = not at all to 100 = highly. The measurements started with first intake of Neurexan or Natural Course and were repeated until 100 minutes after the end of the stress test. The total stress was then summarized with the Area under the curve (AUC) method."|-210 minutes to +100 minutes|33 participants were randomized to Neurexan and 32 participants to Natural Course and all randomized participants were included in the Safety Set. 32 Neurexan and 32 Natural Course participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy.||mm*min||Full Range|Median
670149|NCT01703819|Secondary|Psychological Questionnaire (Modified Somatic SCL90)|"The SCL90 has 90 items with dimensions like depression, somatization, obsessive-compulsive disorder, social insecurity, anxiety, phobic anxiety, aggression/hostility, paranoid ideation, psychoticism and each item in a subscale ranged from 0 to 4. The lower range values are favorable outcomes and higher are worse outcomes. The modified somatic SCL90 uses the SCL90 somatization items, but instead of a 7 day timeframe asks for now. The corresponding items from SCL90 were: 1, 4, 12, 27, 40, 42, 48, 49, 52, 53, 56, 58 and the introductory question: “How much do you currently suffer from” (Wie sehr leiden Sie momentan unter:). The median of the average Modified Somatic SCL90 score is reported. The average score was calculated at each time point as the sum score divided by the number of non-missing individual question results for subjects with no more than 2 missing responses. The lower values in the range represent favorable outcomes while the higher values represent worse outcomes."|-210 minutes, +100 minutes|34 participants were randomized to Neurexan and 32 participants to Placebo and all randomized participants were included in the Safety Set. 34 Neurexan and 30 Placebo participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy.||units on a scale||Full Range|Median
670150|NCT01703819|Secondary|State Anxiety and Stress Perception Measured by STAI-X1|"State anxiety and stress perception were measured by State-Trait Anxiety Inventory X1 before and after a stress test. The measurements took place 90 minutes before the stress test and were repeated at 15 and 100 minutes after the end of the stress test. The German version of the State-Trait-Anxiety Inventory was used and differentiates between temporary/emotional state anxiety versus personality trait anxiety. The two scales with 20 items each assess (1) anxiety as a trait (STAI-X2) and (2) anxiety as a state (STAI-XI). Answers are given in a 4-point rating scale ranging from 1 =not at all to 4 =very true. For analysis of each, STAI-scale single scores were summed up to one total score, representing the state and trait anxiety. Score range is 20-80 and higher scores indicate a higher anxiety."|-90 minutes, +15 minutes, +100 minutes|34 participants were randomized to Neurexan and 32 participants to Placebo and all randomized participants were included in the Safety Set. 34 Neurexan and 30 Placebo participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy.||units on a scale||Full Range|Median
670151|NCT01703819|Secondary|Changes in Heart Rate|"Blood pressure and heart rate were measured before and after a stress test by continuous cardiovascular recording.
The measurements started 30 minutes before stress test and were repeated until 45 minutes after the end of the stress test."|-15 minutes, 0 minutes, +15 minutes, +45 minutes|34 participants were randomized to Neurexan and 32 participants to Placebo and all randomized participants were included in the Safety Set. 34 Neurexan and 30 Placebo participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy.||beats per minute||Full Range|Median
670152|NCT01703819|Secondary|Changes in Blood Pressure|"Blood pressure and heart rate were measured before and after a stress test by continuous cardiovascular recording.
The measurements started 30 minutes before stress test and were repeated until 45 minutes after the end of the stress test."|-15 minutes, 0 minutes, +15 minutes, +45 minutes|34 participants were randomized to Neurexan and 32 participants to Placebo and all randomized participants were included in the Safety Set. 34 Neurexan and 30 Placebo participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy.||mmHg||Full Range|Median
670153|NCT01703819|Secondary|Changes in Natural Killer (NK) Cells (Subgroup)|The Natural Killer Cells as immune cells and stress biomarkers were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test.|-60 minutes, +15 minutes, +45 minutes, +100 minutes|The test was only conducted in the Essen site where 15 participants randomized to Neurexan and 16 participants randomized to Placebo could be evaluated for NK cells.||percentage of lymphocytes||Full Range|Median
670154|NCT01703819|Secondary|Changes in Plasma Catecholamines (Norepinephrine)|The stress biomarkers plasma and saliva cortisol and alpha amylase and Adrenocorticotropic Hormone and catecholamines (norepinephrine and epinephrine) were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test.|-60 minutes, +15 minutes, +45 minutes, +100 minutes|34 participants were randomized to Neurexan and 32 participants to Placebo and all randomized participants were included in the Safety Set. For evaluation of plasma Norepinephrine, 30 Neurexan and 26 Placebo participants were evaluated due to insufficient sample.||ng/L||Full Range|Median
670155|NCT01703819|Secondary|Changes in Plasma Catecholamines (Epinephrine)|The stress biomarkers plasma and saliva cortisol and alpha amylase and Adrenocorticotropic Hormone and catecholamines (norepinephrine and epinephrine) were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test.|-60 minutes, +15 minutes, +45 minutes, +100 minutes|34 participants were randomized to Neurexan and 32 participants to Placebo and all randomized participants were included in the Safety Set. For evaluation of plasma Epinephrine, 30 Neurexan and 26 Placebo participants were evaluated due to insufficient sample.||ng/L||Full Range|Median
670156|NCT01703819|Secondary|Changes in Plasma Cortisol|The stress biomarkers plasma and saliva cortisol and alpha amylase and Adrenocorticotropic Hormone and catecholamines (norepinephrine and epinephrine) were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test.|-60 minutes, +15 minutes, +45 minutes, +100 minutes|34 participants were randomized to Neurexan and 32 participants to Placebo and all randomized participants were included in the Safety Set. For evaluation of plasma Cortisol, 31 Neurexan and 29 Placebo participants were evaluated due to insufficient sample.||nmol/L||Full Range|Median
670157|NCT01703819|Secondary|Changes in Plasma Adrenocorticotropic Hormone (ACTH)|The stress biomarkers plasma and saliva cortisol and alpha amylase and Adrenocorticotropic Hormone and catecholamines (norepinephrine and epinephrine) were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test.|-60 minutes, +15 minutes, +45 minutes, +100 minutes|34 participants were randomized to Neurexan and 32 participants to Placebo and all randomized participants were included in the Safety Set. For evaluation of plasma ACTH, 31 Neurexan and 29 Placebo participants were evaluated due to insufficient sample.||ng/L||Full Range|Median
670213|NCT01703000|Secondary|Stent Area|As measured by IVUS, the area of the stent.|Participants will be followed for the duration of hospital stay, an expected average of 1 day|||mm^2|Participants|Standard Deviation|Mean
670158|NCT01703819|Secondary|Changes in Saliva Cortisol|The stress biomarkers plasma and saliva cortisol and alpha amylase and Adrenocorticotropic Hormone and catecholamines (norepinephrine and epinephrine) were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test.|-60 minutes, +15 minutes, +45 minutes, +100 minutes|34 participants were randomized to Neurexan and 32 participants to Placebo and all randomized participants were included in the Safety Set. 34 Neurexan and 30 Placebo participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy.||nmol/mL||Full Range|Median
670159|NCT01703819|Secondary|Changes in Saliva Alpha Amylase|The stress biomarkers plasma and saliva cortisol, alpha amylase, Adrenocorticotropic Hormone and catecholamines (norepinephrine and epinephrine) were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test.|-60 minutes, +15 minutes, +45 minutes, +100 minutes|34 participants were randomized to Neurexan and 32 participants to Placebo and all randomized participants were included in the Safety Set. 34 Neurexan and 30 Placebo participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy.||IU/mL||Full Range|Median
670160|NCT01703819|Primary|Acute Stress Measured by Nervousness|"Tension and nervousness were self-assessed by the participants on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) before and after a stress test. The VAS is used to determine the subjective impression of tension and nervousness on a 10 cm bipolar visual scale ranging from 0
= not at all to 100 = highly. The measurements started with first intake of Neurexan or Placebo and were repeated until 100 minutes after the end of the stress test. The total stress was then summarized with the Area under the curve (AUC) method."|-210 minutes to +100 minutes|34 participants were randomized to Neurexan and 32 participants to Placebo and all randomized participants were included in the Safety Set. 34 Neurexan and 30 Placebo participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy.||mm*min||Full Range|Median
670161|NCT01703819|Primary|Acute Stress Measured by Tension|"Tension and nervousness were self-assessed by the participants on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) before and after a stress test. The VAS is used to determine the subjective impression of tension and nervousness on a 10 cm bipolar visual scale ranging from 0
= not at all to 100 = highly. The measurements started with first intake of Neurexan or Placebo and were repeated until 100 minutes after the end of the stress test. The total stress was then summarized with the area under the curve (AUC) method."|-210 minutes to +100 minutes|34 participants were randomized to Neurexan and 32 participants to Placebo and all randomized participants were included in the Safety Set. 34 Neurexan and 30 Placebo participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy.||mm*min||Full Range|Median
670162|NCT01703741|Secondary|Average Concentration (Cave) for Total Testosterone and Dihydrotestosterone|"Measurement of total testosterone and DHT levels occur after subjects have been on a stabilized dose of Testosterone Gel for at least one month in the period between Month 3 and Month 6.
The data were presented using descriptive statistics."|Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month)|PP analysis population was used which comprises data from subjects who had 24 hr PK data for testosterone, with no major protocol violations.||ng/dL||Standard Deviation|Mean
670163|NCT01703741|Secondary|Minimum Concentration Observed (Cmin) for Total Testosterone and Dihydrotestosterone|"Measurement of total testosterone and DHT levels occur after subjects have been on a stabilized dose of Testosterone Gel for at least one month in the period between Month 3 and Month 6.
The data were presented using descriptive statistics."|Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month)|PP analysis population was used which comprises data from subjects who had 24 hr PK data for testosterone, with no major protocol violations.||ng/dL||Standard Deviation|Mean
670164|NCT01703741|Secondary|Maximum Concentration Observed (Cmax) for Total Testosterone and Dihydrotestosterone|"Measurement of total testosterone and DHT levels occur after subjects have been on a stabilized dose of Testosterone Gel for at least one month in the period between Month 3 and Month 6.
The data were presented using descriptive statistics."|Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month)|PP analysis population was used which comprises data from subjects who had 24 hr PK data for testosterone, with no major protocol violations.||ng/dL||Standard Deviation|Mean
670165|NCT01703741|Secondary|Time at Which the Maximum Concentration (Tmax) Occurs for Total Testosterone and Dihydrotestosterone|"Measurement of total testosterone and DHT levels occur after subjects have been on a stabilized dose of Testosterone Gel for at least one month in the period between Month 3 and Month 6.
The data were presented using descriptive statistics."|Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month)|PP analysis population was used which comprises data from subjects who had 24 hr PK data for testosterone, with no major protocol violations.||hour||Full Range|Median
670166|NCT01703741|Secondary|Area Under the Concentration-time Curve (AUCτ) for Total Testosterone and Dihydrotestosterone|"Measurement of total testosterone and DHT levels occur after subjects have been on a stabilized dose of Testosterone Gel for at least one month in the period between Month 3 and Month 6.
The data were presented using descriptive statistics."|Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month)|PP analysis population was used which comprises data from subjects who had 24 hr PK data for testosterone, with no major protocol violations.||ng*hr/dL||Standard Deviation|Mean
670167|NCT01703741|Secondary|Percentage of Subjects With a Serum Total Testosterone Level of 1500-1799, 1800-2499, or Above 2500 ng/dL|The data were presented using descriptive statistics.|At Month 6|PP analysis population was used which comprises data from subjects who had 24 hr PK data for testosterone, with no major protocol violations.||percentage of subjects|||Number
670169|NCT01703741|Secondary|Domain Scores for the Short Form-12 (SF-12) Questionnaire|"Data collected from the SF-12 questionnaire was used to assess improvement in the psychometrically-based physical component summary (PCS) and mental component summary (MCS). Both PCS and MCS contains four sub-domains:
PCS: General Health (1 item), Physical Functioning (2 items), Role-Physical (2 items), Bodily Pain (1 item)
MCS: Role-Emotional (2 items), Mental Health (2 items), Vitality (1 item), Social Functioning (1 item)
The scale scores are calculated by summing responses across scale items and then transforming these raw scores to a 0–100 scale. Computerized scoring algorithms are used to produce norm-based scores for each scale (mean of 50 and SD of 10) as well as the PCS and MCS summary scores. A zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
The data were presented using descriptive statistics."|At Month 6|ITT population was used which consists of all the subjects who received at least one dose of the IMP. Of 145 treated subjects, 127 had available SF-12 questionnaire results.||units on a scale||Standard Deviation|Mean
670170|NCT01703741|Secondary|Domain Scores for the Multidimensional Assessments of Fatigue (MAF) Questionnaire|"The MAF contains four sub-domains:
Severity (2 items, questions 1-2) (Score range: 2-20)
Distress (1 item, question 3) (Score range: 1-10)
Degree of interference in activities of daily living (11 items, questions 4-14) (Score range: 11-110)
Timing (2 items, questions 15-16) (Score range: 5-20)
A score of 1-10 is awarded to each of the 14 questions across the 3 domains. The timing domain is categorical and was converted to 1-10 scale by multiplying each score by 2.5. Lower score in each domain indicates improvement in fatigue.
To calculate GFI : Score of question 15 is converted to a 0-10 scale by multiplying each score by 2.5 and then sum scores of questions 1, 2, 3, average of 4-14, and newly scored question 15. A score of zero is assigned to question 2-16, if patient select 'no fatigue' to question 1. Question 16 is not included in GFI calculation. Range of GFI: 1 (no fatigue) to 50 (severe fatigue).
The data were presented using descriptive statistics."|At Month 6|ITT population was used which consists of all subjects who received at least one dose of the IMP. Of 145 treated subjects, 127 had available MAF questionnaire results.||units on a scale||Standard Deviation|Mean
670171|NCT01703741|Secondary|Percentage of Subjects With a Negative Androgen Deficiency in the Aging Male (ADAM) Questionnaire|"In ADAM questionnaire, subjects had to respond in yes or no to 10 questions. A positive result (with severity and symptoms of low testosterone) on the questionnaire was defined as an affirmative answer (yes) to questions 1 or 7, or to any 3 other questions.
The data were presented using descriptive statistics."|At Month 6|ITT population was used which consists of all the subjects who received at least one dose of the IMP. Of 145 treated subjects, 127 had available ADAM questionnaire results.||percentage of subjects|||Number
670172|NCT01703741|Secondary|Domain Scores for the International Index of Erectile Function (IIEF) Questionnaire|"Data collected from the five domains of sexual functions were summarized by descriptive statistics.
The domains are:
Erectile function (6 items, questions 1-5 and 15) (Score range: 1-30)
Orgasmic function (2 items, questions 9-10) (Score range: 0-10)
Sexual desire (2 items, questions 11-12) (Score range: 2-10)
Intercourse satisfaction (3 items, questions 6-8) (Score range: 0-15)
Overall satisfaction (2 items, questions 13-14) (Score range: 2-10)
A score of 0-5 is awarded to questions 1-10 and a score of 1-5 is awarded to questions 11-15. Low score indicates severe dysfunction and a high score indicates no dysfunction in sexual function, in each domain."|At Month 6|ITT population was used which consists of all subjects who received at least one dose of the IMP. Of 145 treated subjects, 127 had available IIEF questionnaire results.||units on a scale||Standard Deviation|Mean
670173|NCT01703741|Secondary|Percentage of Subjects With a Serum Total Testosterone Level (Average Steady State Concentration [Cave]) Between 300 and 1050 ng/dL.|"Measurement of total testosterone level occur after subjects have been on a stabilized dose of testosterone gel for at least one month in the period between Month 3 and Month 6.
The data were presented using descriptive statistics."|Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month)|PP analysis population was used which comprises data from subjects who had 24 hr PK data for testosterone, with no major protocol violations.||percentage of subjects|||Number
670174|NCT01703741|Primary|Percentage of Subjects With a Serum Total Testosterone Level - Maximum Observed Concentration (Cmax) of 1500-1799, 1800-2499, or Above 2500 ng/dL|"Measurement of total testosterone level occur after subjects have been on a stabilized dose of testosterone gel for at least one month in the period between Month 3 and Month 6.
The data were presented using descriptive statistics."|Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month)|PP analysis population was used which comprises data from subjects who had 24 hr PK data for testosterone, with no major protocol violations.||percentage of subjects|||Number
670175|NCT01703702|Secondary|Change in Patient Management: Individual Categories|Compare the percentage of patients with a change from baseline in the individual patient management categories at 3 months in the interventional and control arms.The individual categories are: Major diagnostic tests, Alzheimer’s/cognition medication, neuropsychological tests, physician follow-up for re-evaluation or specialist referral.|Baseline and 3 months|Analysis population for this endpoint only includes those patients with both a baseline and follow-up value.||percentage of patients|||Number
670176|NCT01703702|Secondary|Change in Caregiver Self-efficacy|Comparison of the change in self-efficacy between intervention and control arms. Change in self-efficacy is defined as the difference between total score on the Fortinsky: Family caregivers’ self-efficacy for managing dementia scale at Follow-up (3 months) and baseline. Self-efficacy for managing dementia is defined in terms of specific behaviors or tasks that can be learned, and that are highly relevant to daily management of the disease process. The scale consists of 10 questions, each with responses ranging from 1 (not at all certain) to 10 (very certain). The total score is calculated by summing the response for each item. The total score ranges from 10 to 100, with increasing scores representing increasing caregiver self-efficacy.|Baseline and 3 months|Analysis population for this endpoint only includes those patients with both a baseline and follow-up value.||units on a scale||Standard Error|Least Squares Mean
670177|NCT01703702|Secondary|Change in Patient Management: Advice/Counseling|Comparison of the percentage of patients in the intervention and control arms who have a change in management relating to advice and counseling from baseline to 3 months.|Baseline and 3 months|Analysis population for this endpoint only includes those patients with both a baseline and follow-up value.||percentage of patients|||Number
670178|NCT01703702|Secondary|Change in Diagnostic Confidence|Comparison of the percentage point change in the physician's diagnostic confidence from baseline to month 3 in the intervention and control arms for patients whose scan result was predicted by their baseline clinical diagnosis. Diagnostic confidence was recorded by the physician as a whole number percent from 0-100% and the change in confidence was calculated by subtracting the baseline confidence from the confidence recorded at the specified timepoint. Values greater than zero reflect increased diagnostic confidence; values less than zero reflect decreased diagnostic confidence.|Baseline and 3 months|Analysis population for this endpoint only includes those patients whose scan result was predicted by their baseline clinical diagnosis and recorded both a baseline and follow-up value.||Percentage Point||Standard Error|Least Squares Mean
670179|NCT01703702|Secondary|Change in Patient's Clinical Diagnosis|Comparison of the percentage of patients who have a change in diagnosis from baseline to 3 months for patients in the intervention and control arms for whom the scan result was not predicted by the initial diagnosis.|Baseline and 3 months|Analysis population for this endpoint only includes those patients whose scan result was not predicted by their baseline clinical diagnosis and recorded both a baseline and follow-up value.||percentage of patients|||Number
670180|NCT01703702|Primary|Change in ADAS-Cog 11 Total Score|Change from baseline in the Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog) 11 Score in patients with mild impairment by positive or negative florbetapir (18F) PET scan result (Aß+/Aß-). ADAS-Cog scores (range 0-70) indicate performance on a series of 11 cognitive tasks where 0 indicates the highest level of cognitive performance and 70 indicates the lowest level of cognitive performance. Change in ADAS-Cog scores were calculated by subtracting the baseline score from the 12 month score. A change in ADAS-Cog greater than 0 indicates a deterioration in cognitive performance whereas a change in ADAS-Cog less than 0 indicates improved cognitive performance.|Baseline and 12 months|Analysis population for this endpoint only includes those patients with mild cognitive impairment, and who reported both a baseline and follow-up value.||units on a scale||Standard Error|Least Squares Mean
670181|NCT01703702|Primary|Clinical and Diagnostic Change in Patient Management|Comparison of the percentage of patients who have a change in management from baseline to 3 months for patients who receive scan results immediately (intervention arm) and those who receive scan results 12 months later (control arm).|Baseline and 3 months|Analysis population for this endpoint only includes those patients with both a baseline and follow-up value.||percentage of patients|||Number
670182|NCT01703663|Primary|Apnea-hypopnea Index|Apnea-hypopnea index (AHI) is the sum of the apneas and hypopneas and divided by the hours of sleep based on actigraphy. AHI values are typically categorized as 5-15/hr = mild; 15-30/hr = moderate; and >= 30/h = severe. The prespecified primary (absolute) treatment effect is based on the linear repeated measures model.|night 1 and night 2|||apneas plus hypopneas per hour||Inter-Quartile Range|Median
670183|NCT01703286|Secondary|Number of Patients With Adverse Events|Number of patients with any adverse events|up to 20 weeks|Treated set (TS)||participants|||Number
670184|NCT01703286|Secondary|Change From Baseline in 2 Hours Post Meal Endothelial Independent Vasodilation (EIDV) on Day 28|Endothelial function 2h post-meal was measured by endothelial independent vasodilation (EIDV). The change from baseline was calculated as the value on Day 28 divided by the respective value at baseline.|baseline and day 28 for each treatment arm|Efficacy set (ES)- included all patients of the TS who provided at least 1 observation for at least 1 primary, secondary, or other efficacy endpoint without important protocol violations relevant for the statistical evaluation of these endpoints.||percentage||90% Confidence Interval|Mean
670185|NCT01703286|Secondary|Change From Baseline in Flow Mediated Vasodilation (FMD) 2 h Post Meal on Day 28|Endothelial function 2 hours post meal was measured with flow mediated vasodilation (FMD). The change from baseline was calculated as the value on Day 28 divided by the respective value at baseline.|baseline and day 28 for each treatment arm|||Percentage||90% Confidence Interval|Geometric Mean
670186|NCT01703286|Primary|Change From Baseline in Flow Mediated Vasodilation (FMD) Under Fasted Condition on Day 28|Endothelial function under fasted condition was measured with flow mediated vasodilation (FMD). The change from baseline was calculated as the value on Day 28 divided by the respective value at baseline.|baseline and day 28 for each treatment arm|Efficacy set (ES)- included all patients of the TS who provided at least 1 observation for at least 1 primary, secondary, or other efficacy endpoint without important protocol violations relevant for the statistical evaluation of these endpoints.||percentage||90% Confidence Interval|Geometric Mean
670187|NCT01703260|Secondary|Change From Baseline in Liver Fat Content at Month 4|Liver fat content was quantitatively measured by evaluating the percentage of PDFF from an abdominal MRI. On the basis of Couinaud classification (a classification used to describe functional liver anatomy), the liver was divided into 8 segments: caudate, left superolateral, left inferolateral, left superomedial (4a), left inferomedial (4b), right anteroinferior, right posteroinferior, right posterosuperior and right anterosuperior.|Baseline and Month 4|Safety analysis set included all participants who were randomized, received at least 1 dose of double-blind study medication and had baseline and at least 1 post-baseline assessment available.||percent change in PDFF||Standard Deviation|Mean
670188|NCT01703260|Secondary|Liver Fat Content at Baseline|Liver fat content was quantitatively measured by evaluating the percentage of proton density fat fraction (PDFF) from an abdominal magnetic resonance imaging (MRI). On the basis of Couinaud classification (a classification used to describe functional liver anatomy), the liver was divided into 8 segments: caudate, left superolateral, left inferolateral, left superomedial (4a), left inferomedial (4b), right anteroinferior, right posteroinferior, right posterosuperior and right anterosuperior.|Baseline|Safety analysis set included all participants who were randomized, received at least 1 dose of double-blind study medication and had baseline assessment available.||percentage of PDFF||Standard Deviation|Mean
670189|NCT01703260|Secondary|Percent Change From Baseline in Serum AST at Month 4|The percent change between the serum AST value collected at Month 4 or final visit relative to baseline.|Month 4|Safety analysis set included all participants who were randomized, received at least 1 dose of double-blind study medication and had baseline and at least 1 post-baseline assessment available.||percent change||Standard Deviation|Mean
670190|NCT01703260|Secondary|Amount of Serum Aspartate Transaminase (AST) at Baseline||Baseline|Safety analysis set included all participants who were randomized, received at least 1 dose of double-blind study medication and had baseline assessment available.||IU/L||Standard Deviation|Mean
670191|NCT01703260|Primary|Percent Change From Baseline in Serum ALT at Month 4|The percent change between the serum ALT value collected at Month 4 or final visit relative to baseline.|Month 4|Safety analysis set included all participants who were randomized, received at least 1 dose of double-blind study medication and had baseline and at least 1 post-baseline assessment available.||percent change||Standard Deviation|Mean
670192|NCT01703260|Primary|Amount of Serum Alanine Transaminase (ALT) at Baseline||Baseline|Safety analysis set included all participants who were randomized, received at least 1 dose of double-blind study medication and had baseline assessment available.||international units per liter (IU/L)||Standard Deviation|Mean
670193|NCT01703221|Secondary|Change From Baseline for Fasting Plasma Glucose (FPG) at Week 24|Blood glucose was measured on a fasting basis. FPG is expressed as mg/dL. Blood was drawn at predose on Day 1 and after 24 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 24 minus FPG at baseline).|Baseline and Week 24|The FAS Population consisted of all randomized participants who had at least one study drug and had a baseline or post-randomization measurement for this outcome measure.||mg/dL||95% Confidence Interval|Least Squares Mean
670194|NCT01703221|Secondary|Change From Baseline for 2-hour Post Meal Glucose (PMG) at Week 24|Change from baseline at Week 24 is defined as PMG at Week 24 minus PMG at Week 0.|Baseline and Week 24|The FAS Population consisted of all randomized participants who had at least one study drug and had a baseline or post-randomization measurement for this outcome measure.||mg/dL||95% Confidence Interval|Least Squares Mean
670195|NCT01703221|Primary|Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During the Overall Study|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. These results represent the accrual of events over different treatment intervals: 52 weeks, omarigliptin (Phase A+B) defined as the double-blind period and open label extension period versus 28 weeks for the Sitagliptin (Phase A)→Omarigliptin (Phase B) and placebo (Phase A)→Omarigliptin (Phase B) group defined as the open-label extension period only.|Up to 52 weeks|The ASaT Population consisted of all randomized participants who received at least one study drug. Data was unavailable for 7 participants who discontinued the study in sitagliptin and placebo arms in Phase A.||Percentage of participants|||Number
670196|NCT01703221|Primary|Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During Phase A|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to 24 weeks|The ASaT Population consisted of all randomized participants who received at least one study drug.||Percentage of participants|||Number
670197|NCT01703221|Primary|Percentage of Participants Who Experienced at Least One Adverse Event During the Overall Study|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. These results represent the accrual of events over different treatment intervals: 52 weeks, omarigliptin (Phase A+B) defined as the double-blind period and open label extension period versus 28 weeks for the Sitagliptin (Phase A)→Omarigliptin (Phase B) and placebo (Phase A)→Omarigliptin (Phase B) group defined as the open-label extension period only.|Up to 52 weeks|The ASaT Population included all randomized participants who received at least one study drug. Data was unavailable for 7 participants who discontinued the study in sitagliptin and placebo arms in Phase A.||Percentage of Participants|||Number
670198|NCT01703221|Primary|Percentage of Participants Who Experienced at Least One Adverse Event During Phase A|An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to 24 weeks|All Subjects as Treated (ASaT) population consisted of all randomized participants who received at least one study drug.||Percentage of participants|||Number
670199|NCT01703221|Primary|Change From Baseline for Hemoglobin A1c (HbA1c) at Week 24|HbA1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Change in A1C following 24 weeks of therapy (i.e., A1C at Week 24 minus A1C at baseline).|Baseline and Week 24|The Full Analysis Set (FAS) consisted of all randomized participants who had at least one study drug and had a baseline or post-randomization measurement for this outcome measure.||Percent HbA1c||95% Confidence Interval|Least Squares Mean
670200|NCT01703091|Secondary|Change From Baseline in Lung Cancer Symptom Scale (LCSS)|The participant-reported LCSS was a 9-item questionnaire. Six items were symptom-specific measures for lung cancer (loss of appetite, fatigue, cough, dyspnea, hemoptysis, and pain), and 3 summation items described total symptomatic distress, interference with activity level, and global quality of life. Participant responses to each item were measured using a visual analog scale (VAS) from 0 (best outcome) to 100 (worst outcome). The Average Symptom Burden Index (ASBI) was the mean of the 6 symptom-specific items in the LCSS. The Total LCSS was the mean of all 9 LCSS items. Maximum improvement in LCSS scores, ASBI, and Total LCSS score was the largest decrease from baseline for each variable, which was the smallest (most negative or smallest positive) non-missing value among all change from baseline values for each variable.|Baseline to Measured Progressive Disease or Participant Stopped Study (up to 97 weeks)|FAS population: All randomized participants who received at least one dose of study drug and whose prior therapy did not include EGFR-TKI monotherapy.||Millimeter||Standard Deviation|Mean
670214|NCT01703000|Secondary|Vessel Area|As measured by IVUS, the mean vessel area (mm2).|Participants will be followed for the duration of hospital stay, an expected average of 1 day|||mm^2|Participants|Standard Deviation|Mean
670215|NCT01703000|Secondary|Acute Gain|Acute gain, as measured by angiographic core lab|Participants will be followed for the duration of hospital stay, an expected average of 1 day|||mm||Standard Deviation|Mean
670331|NCT01702233|Secondary|Changes From Baseline in ROM in Degrees (Active External Rotation in Abduction) After Visit 5 (Day 22) Traumeel vs Fortecortin|Range of movement (ROM) changes measured by active external rotation in abduction in degrees by goniometry in the range of 0 to 360 degrees.|Baseline vs. Day 22|||degrees||Standard Deviation|Mean
670201|NCT01703091|Secondary|Change From Baseline in European Quality of Life Questionnaire - 5 Dimension (EQ-5D) Index Score|The EQ-5D is a quality-of-life instrument which allowed participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a scale from 1 to 3 (no problem, some problems, and extreme problems, respectively). These combinations of attributes were converted into a weighted Health State Index score according to a United Kingdom population-based algorithm; the possible values for the Health State Index score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension).|Baseline, Day 21 Each Cycle (Cycle = 21 Days) and 30-Day Follow Up (Up to 97 Weeks)|FAS population: All randomized participants who received at least one dose of study drug and whose prior therapy did not include EGFR-TKI monotherapy.||Units on a Scale||Standard Deviation|Mean
670202|NCT01703091|Secondary|Percentage of Participants Who Achieved Best Overall Disease Response of CR, PR or Stable Disease (SD) [Disease Control Rate (DCR)]|Participants achieved disease control if they had a best overall response of PR, CR or SD. According to RECIST v1.1, CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels (if tumor markers were initially above the upper limit of normal [ULN]); PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter. SD was neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started. The percentage of participants who achieved disease control equals (number of participants with CR, PR, or SD)/(number of participants assessed)*100.|Baseline to Measured Progressive Disease or Participant Stopped Study (Up to 97 Weeks)|FAS population: All randomized participants who received at least one dose of study drug and whose prior therapy did not include EGFR-TKI monotherapy.||Percentage of Participants||95% Confidence Interval|Number
670203|NCT01703091|Secondary|Percentage of Participants Who Achieved Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) [Objective Tumor Response Rate (ORR)]|Participants achieved an objective response if they had a best overall response of complete response (CR) or partial response (PR). According to RECIST v1.1, CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels (if tumor markers were initially above the upper limit of normal [ULN]); PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter. The percentage of participants who achieved an objective response equals (number of participants with CR or PR)/(number of participants assessed)*100.|Baseline to Measured Progressive Disease or Participant Stops Study (Up to 97 Weeks)|FAS population: All randomized participants who received at least one dose of study drug and whose prior therapy did not include EGFR-TKI monotherapy.||Percentage of Participants||95% Confidence Interval|Number
670204|NCT01703091|Secondary|Overall Survival (OS)|OS was defined as time from baseline to the date of death from any cause. Participants who were alive at the end of the follow-up period (or lost to follow‑up) were censored on the last date the participant was known to be alive.|Baseline to Death from Any Cause (Up to 28 Months)|FAS population: All randomized participants who received at least one dose of study drug and whose prior therapy did not include EGFR-TKI monotherapy. The number of censored participant data for ramucirumab and placebo is 36 and 35, respectively.||Months||95% Confidence Interval|Median
670205|NCT01703091|Primary|Progression-Free Survival (PFS)|PFS was defined as the time from baseline until measured progressive disease (PD) or death from any cause, whichever is first. According to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1), PD was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the 20% relative increase, the sum must have also demonstrated an absolute increase of at least 5 millimeters (mm). The appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions was also considered progression. Participants without objectively determined PD, who were alive at the end of the follow-up period (or lost to follow‑up), were censored on the date of the participant's last complete radiographic tumor assessment; if no baseline or post-baseline radiologic assessment was available, the participant was censored at the date of randomization.|Baseline to Measured Progressive Disease or Death from Any Cause (Up to 21 Months)|Full Analysis Set (FAS) population: All randomized participants who received at least one dose of study drug and whose prior therapy did not include EGFR-TKI monotherapy. The number of censored participant data for ramucirumab and placebo is 13 and 9, respectively.||Months||95% Confidence Interval|Median
670206|NCT01703000|Secondary|Longitudinal Stent Deformation|Longitudinal stent deformation, evidenced by longitudinal compression or elongation, as the result of crossing a newly deployed stent with a second device, (such as a balloon catheter, stent system or IVUS catheter), causing the second device to become caught on the stent when the second device is advanced or retracted.|Participants will be followed for the duration of hospital stay, an expected average of 1 day|||percentage of stents|||Number
670207|NCT01703000|Secondary|Percent Net Volume Obstruction|The percentage of volume obstruction, as measured by the IVUS core lab.|Participants will be followed for the duration of hospital stay, an expected average of 1 day|||% of volume|Participants|Standard Deviation|Mean
670208|NCT01703000|Secondary|Incomplete Apposition|"Incomplete apposition rate, as measured by the IVUS core lab.
Binary assessment of presence of one or more stent struts separated from the vessel wall as detected through intravascular ultrasound (IVUS)."|Participants will be followed for the duration of hospital stay, an expected average of 1 day|||percentage of lesions|Participants||Number
670209|NCT01703000|Secondary|Lumen Volume|As measured by IVUS, the volume of the lumen.|Participants will be followed for the duration of hospital stay, an expected average of 1 day|||mm^3|Participants|Standard Deviation|Mean
670210|NCT01703000|Secondary|Stent Volume|As measured by IVUS, the volume of the stent.|Participants will be followed for the duration of hospital stay, an expected average of 1 day|||mm^3|Participants|Standard Deviation|Mean
670211|NCT01703000|Secondary|Vessel Volume|As measured by IVUS, the volume of the vessel.|Participants will be followed for the duration of hospital stay, an expected average of 1 day|||mm^3|Participants|Standard Deviation|Mean
670212|NCT01703000|Secondary|Lumen Area|As measured by IVUS, the area of the lumen.|Participants will be followed for the duration of hospital stay, an expected average of 1 day|||mm^2|Participants|Standard Deviation|Mean
670216|NCT01703000|Secondary|In-segment Minimum Lumen Diameter (MLD)|"As measured by an independent angiographic core laboratory using quantitative coronary angiography (QCA); the minimum lumen diameter (MLD) measured at the in-segment region (in-segment includes the stented region and 5 mm edge regions).
The MLD is the mean minimum lumen diameter (mm) from 2 orthogonal views."|Participants will be followed for the duration of hospital stay, an expected average of 1 day|||mm|Participants|Standard Deviation|Mean
670217|NCT01703000|Secondary|In-stent Minimum Lumen Diameter (MLD)|"As measured by an independent angiographic core laboratory using quantitative coronary angiography (QCA); the minimum lumen diameter (MLD) measured at the in-stent region.
The MLD is the mean minimum lumen diameter (mm) from 2 orthogonal views."|Participants will be followed for the duration of hospital stay, an expected average of 1 day|||mm|Participants|Standard Deviation|Mean
670218|NCT01703000|Secondary|In-segment Percent Diameter Stenosis (%DS)|"As measured by an independent angiographic core laboratory using quantitative coronary angiography (QCA), the % diameter stenosis of the in-segment region (in-segment includes the stented region and 5 mm edge regions).
Percent diameter stenosis: Relative changes that occur in the percent diameter stenosis are provided by the following relationship: % diameter stenosis= (1-[Minimum Lumen Diameter/Reference diameter]) x 100."|Participants will be followed for the duration of hospital stay, an expected average of 1 day|||Diameter Stenosis, In-Segment (%)|Participants|Standard Deviation|Mean
670219|NCT01703000|Secondary|In-stent Percent Diameter Stenosis (%DS)|"As measured by an independent angiographic core laboratory using quantitative coronary angiography (QCA), the % diameter stenosis of the in-stent region.
Percent diameter stenosis: Relative changes that occur in the percent diameter stenosis are provided by the following relationship: % diameter stenosis= (1-[Minimum Lumen Diameter/Reference diameter]) x 100."|Participants will be followed for the duration of hospital stay, an expected average of 1 day|||In-Stent % Diameter Stenosis|Participants|Standard Deviation|Mean
670220|NCT01703000|Secondary|Clinical Procedural Success Rate|"Clinical procedural success is post-procedure diameter stenosis <30% in 2 near-orthogonal projections with TIMI 3 flow in all target lesions, as visually assessed by the physician, without the occurrence of in-hospital MI, TVR, or cardiac death.
MI definition used was the PLATINUM definition for MI."|Participants will be followed for the duration of hospital stay, an expected average of 1 day|||percentage of participants||95% Confidence Interval|Number
670221|NCT01703000|Secondary|Stent Thrombosis Rate (by Academic Research Consortium [ARC] Definitions)|"Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guide catheter has been removed and the patient left the catheterization lab.
Timing:
Acute stent thrombosis*: 0 24 hours after stent implantation
Subacute stent thrombosis*: >24 hours to 30 days after stent implantation
Late stent thrombosis: >30 days to 1 year after stent implantation
Very late stent thrombosis: >1 year after stent implantation * Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis is 0 30 days.
Stent thrombosis may be defined as:
Confirmed/definite
Probable
Possible
Confirmed/Definite (is considered either angiographic confirmed or pathologic confirmed)"|Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days|||percentage of participants|||Number
670222|NCT01703000|Secondary|All Death/MI/TVR Rate|"Any event meeting the pre-specified criteria for any death, MI, or TVR.
MI definition used was the PLATINUM definition for MI."|Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days|||percentage of participants|||Number
670223|NCT01703000|Secondary|All Death or MI Rate|"Any all-cause mortality event or MI meeting the criteria defined for any death or MI.
MI definition used was the PLATINUM definition for MI."|Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days|||percentage of participants|||Number
670224|NCT01703000|Secondary|Cardiac Death or MI Rate|"Any cardiac death or MI event meeting the criteria defined for a cardiac death or MI.
MI definition used was the PLATINUM definition for MI."|Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days|||percentage of participants|||Number
670225|NCT01703000|Secondary|All Death Rate|Death is categorized as cardiac or non-cardiac deaths.|Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days|||percentage of participants|||Number
670226|NCT01703000|Secondary|Non-cardiac Death Rate|"Non-cardiac death is defined as a death not due to any of the following:
Acute MI
Cardiac perforation/pericardial tamponade
Arrhythmia or conduction abnormality
CVA through hospital discharge or CVA suspected of being related to the procedure
Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery
Any death in which a cardiac cause cannot be excluded"|Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days|||percentage of participants|||Number
670227|NCT01703000|Secondary|Cardiac Death Rate|"Cardiac death is defined as death due to any of the following.
Acute MI
Cardiac perforation/pericardial tamponade
Arrhythmia or conduction abnormality
CVA through hospital discharge or CVA suspected of being related to the procedure
Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery
Any death in which a cardiac cause cannot be excluded"|Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days|||percentage of participants|||Number
670228|NCT01703000|Secondary|Myocardial Infarction (MI, Q-wave and Non-Q-wave) Rate|MI will be defined according to the PLATINUM Definition of MI with evidence pre-specified for i) Spontaneous, ii) PCI-related, iii) CABG related, and iv) autopsy evidence criteria.|Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days|||percentage of participants|||Number
670229|NCT01703000|Secondary|Target Vessel Failure (TVF) Rate|"Target vessel failure is any ischemia-driven revascularization of the target vessel, MI (Q-wave and non–Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.
The MI definition used was the PLATINUM MI definition."|Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days|||percentage of participants|||Number
670332|NCT01702233|Secondary|Changes From Baseline in ROM in Degrees (Active External Rotation in Abduction) After Visit 7 (Day 105), Traumeel vs Placebo|Range of movement (ROM) changes measured by active external rotation in abduction in degrees by goniometry in the range of 0 to 360 degrees.|Baseline vs. day 105|||degrees||Standard Deviation|Mean
670230|NCT01703000|Secondary|Target Vessel Revascularization (TVR) Rate|"Target vessel revascularization is defined as a TLR or a TVR remote. Target vessel revascularization remote is any ischemia-driven repeat percutaneous intervention, to improve blood flow, or bypass surgery of not previously existing lesions diameter stenosis >/= 50% by QCA in the target vessel, excluding the target lesion. A TVR will be considered ischemia-driven if the target vessel diameter stenosis is >/= 50% by QCA and any of the following are present:
The subject has a positive functional study corresponding to the area served by the target vessel.
The subject has ischemic ECG changes at rest in a distribution consistent with the target vessel.
The subject has ischemic symptoms referable to the target vessel. A TVR will also be considered as ischemia-driven if the lesion diameter stenosis is >/=70% even in the absence of clinical or functional ischemia."|Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days|||percentage of participants|||Number
670231|NCT01703000|Secondary|Target Lesion Failure (TLF) Rate|"Target lesion failure is any ischemia-driven revascularization of the target lesion, MI (Q-wave and non–Q-wave) related to the target vessel, or (cardiac) death. For the purposes of this protocol, if it cannot be determined with certainty whether the MI was related to the target vessel, it will be considered a TLF.
The MI definition used for Target Lesion Failure was the PLATINUM MI definition."|Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days|||percentage of participants|||Number
670232|NCT01703000|Secondary|Target Lesion Revascularization (TLR) Rate|"Target lesion revascularization is any ischemia-driven repeat percutaneous intervention, to improve blood flow, of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion. A TLR will be considered as ischemia-driven if the target lesion diameter stenosis is >/= 50% by QCA and there is presence of clinical or functional ischemia which cannot be explained by other coronary or graft lesions. Clinical or functional ischemia is any of the following:
The subject has a positive functional study corresponding to the area served by the target lesion.
The subject has ischemic ECG changes at rest in a distribution consistent with the target vessel.
The subject has ischemic symptoms referable to the target lesion. A TLR will be considered as ischemia-driven if the lesion diameter stenosis is >/= 70% by QCA even in the absence of clinical or functional ischemia."|Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days|||percentage of participants|||Number
670233|NCT01703000|Primary|Technical Success Rate|Technical success is defined as successful delivery and deployment of the study stent to the target lesion, without balloon rupture or stent embolization, and post-procedure diameter stenosis of <30% assessed in 2 near-orthogonal projections with TIMI 3 flow in the target lesion, as visually assessed by the physician|Participants will be followed for the duration of hospital stay, an expected average of 1 day|||percentage of lesions|Participants|95% Confidence Interval|Number
670234|NCT01702987|Primary|Phosphocreatine Recovery|Percentage change in phosphocreatine recovery from baseline to month as measured by 31PMRS is the primary outcome measure is a representative of mitochondrial oxidative capacity|1 month|||percentage change from baseline||Standard Error|Mean
670235|NCT01702961|Secondary|Number of Participants With Overall Best Response Achieved After Transplantation|Response was summarized as complete remission (CR): disappearance of all evidence of disease; partial remission (PR): regression of measurable disease (>=50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses) and no new sites; stable disease (SD): failure to attain CR/PR/PD; relapsed disease or progressive disease (PD): any new lesion or increase by >= 50% of previously involved sites from nadir.|3 months post-transplant|Analysis comprised of all participants who received standard BEAM chemotherapy and adjuvant rituximab while undergoing autologous blood stem cell transplantation for high-risk lymphoma or Hodgkin’s disease.||participants|||Number
670236|NCT01702961|Secondary|Median Days to Neutrophil Engraftment|Neutrophil engraftment was recorded as the first day that absolute neutrophil counts (ANC) exceeds 0.5 X 10^9/L for three consecutive readings.|30 days post-transplant|All of the participants enrolled in the study engrafted.||days||Full Range|Median
670237|NCT01702961|Primary|Disease-free Survival|Disease-free survival at 12 months post-transplant in patients with Hodgkin's disease or non-Hodgkin’s lymphomas|12 months post-transplant|||percentage of participant||95% Confidence Interval|Number
670241|NCT01702532|Secondary|The Change From Pre-dose Post-provocation in Craving Score at 3, 5, 7, 10, 15, 20, 25, and 30 Minutes|Participants completed a cigarette craving assessment consisting of the following five items: “I have a desire for a cigarette right now; If it were possible I would smoke right now; All I want right now is a cigarette; I have an urge for a cigarette; I crave a cigarette right now. All participants indicated craving intensity on a pre-drawn 100 mm VAS ranging from 0 (disagree) to 100 (agree). The average of the scores over the five items was defined as the craving score for each time .|Pre-dosing post-provocation to 3, 5, 7, 10, 15, 20, 25, and 30 minutes|||mm||95% Confidence Interval|Least Squares Mean
670242|NCT01702532|Primary|The Change From Pre-dose Post-provocation in Craving Score at 50 Seconds|Participants completed a cigarette craving assessment consisting of the following five items: “I have a desire for a cigarette right now; If it were possible I would smoke right now; All I want right now is a cigarette; I have an urge for a cigarette; I crave a cigarette right now. All participants indicated craving intensity on a pre-drawn 100 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 (disagree) to 100 (agree). The average of the scores over the five items was defined as craving score for each time point.|Pre-dosing post-provocation to 50 seconds|All randomized participants who took at least one dose of medication and provided at least one valid craving assessment measurement on-treatment. Any participant with a missing response to any of the five craving assessment items was considered as a missing value and was imputed.||mm||Inter-Quartile Range|Least Squares Mean
670243|NCT01702519|Secondary|Rate of Elimination (Kel)|Following randomization, the nicotine patches; reference nicotine patch or test nicotine patch (as per the assigned sequence), were applied on participant’s upper back or arm. Elimination rate constant for nicotine was determined from plasma concentration time profiles. Blood samples were drawn at several time points: immediately pre-dose, and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 20, 24, 25, 26, 28, and 32 hours the application of the patch. Patch was then removed after the collection of 24 hour blood sample. Elimination rate constant for nicotine was based on the baseline adjusted nicotine plasma concentration data.|Baseline to 32 hours|Per protocol population, which included all randomized participants who took at least one dose of the study medications, had no protocol violations, and whose data was considered evaluable by the pharmacokineticist.||1/hr||Full Range|Median
670244|NCT01702519|Secondary|Plasma Half-life (t1/2)|Following randomization, the nicotine patches; reference nicotine patch or test nicotine patch (as per the assigned sequence), were applied on participant’s upper back or arm. The elimination half-life of nicotine was determined by from plasma concentration time profiles. Blood samples were drawn at several time points: immediately pre-dose, and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 20, 24, 25, 26, 28, and 32 hours after the application of the patch. Patch was then removed after the collection of 24 hour blood sample. Plasma half-life (t1/2) was based on the baseline adjusted nicotine plasma concentration data|Baseline to 32 hours|Per-prorocol population, which included all randomized participants who received at least one dose of the study treatment, had no protocol violation, and whose data was considered evaluable by the pharmacokineticist.||Hrs||Full Range|Median
670245|NCT01702519|Secondary|Time to Maximum Plasma Concentration (Tmax)|Following randomization, the nicotine patches; reference nicotine patch or test nicotine patch (as per the assigned sequence), were applied on participant’s upper back or arm. Time to Maximum Plasma Concentration was determined from plasma concentration time profiles. Blood samples were drawn at various time points; immediately pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 20, 24, 25, 26, 28, and 32 hours after application of the patch. Patch was then removed after the collection of 24 hour blood sample. Tmax was based on the baseline adjusted nicotine plasma concentration data.|Baseline to 32 hours|Per protocol population, which included all randomized participants who took at least one dose of the drug, did not have any protocol deviations and whose data was considered evaluable by the pharmacokineticist.||hrs||Full Range|Median
670246|NCT01702519|Secondary|Area Under the Concentration Time Curve Between Zero and Infinity, AUC (0-inf)|Following randomization, the nicotine patches; reference nicotine patch or test nicotine patch (as per the assigned sequence), were applied on participant’s upper back or arm. Area under the plasma nicotine concentration time curve from zero extrapolated to infinity was determined by plasma concentration time profile of nicotine. Blood samples drawn at various time points including: immediately pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 20, 24, 25, 26, 28, and 32 hours after wearing the patch. Patch was then removed after the collection of 24 hour blood sample. AUC(0 -inf) was based on the baseline adjusted nicotine plasma concentration data.|Baseline to 32 hours|Per Protocol Population, which consisted of all randomized participants who took at least one dose of the study treatment, did not have any protocol deviation, and provided enough pharmacokinetic data as determined by the pharmacokineticist.||ng*h/mL||Standard Deviation|Mean
670247|NCT01702519|Primary|Maximum Measured Plasma Concentration (Cmax)|Following randomization, the nicotine patches; reference nicotine patch or test nicotine patch (as per the assigned sequence), were applied on participant’s upper back or arm. Maximum plasma nicotine concentration was determined from plasma concentration time profiles. Blood samples were drawn at various time points: immediately pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 20, 24, 25, 26, 28, and 32 hours after application the patch. Patch was then removed after the collection of 24 hour blood sample. Cmax was based on the baseline adjusted nicotine plasma concentration data.|Baseline to 32 hours|Per Protocol Population, which consisted of all randomized participants who took at least one dose of the study treatment, did not have any protocol deviation, and provided enough pharmacokinetic data as determined by the pharmacokineticist.||ng/mL||Standard Deviation|Mean
670248|NCT01702519|Primary|Area Under the Curve From Time 0 to the Last Quantifiable Sample, AUC(0-t)|Following randomization, the nicotine patches; reference nicotine patch or test nicotine patch (as per the assigned sequence), were applied on participant’s upper back or arm. Area under the plasma concentration time curve from zero and extrapolated to the time of last quantifiable sample was determined by plasma concentration time profile of nicotine. Blood samples were drawn at the following time intervals: immediately pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 20, 24, 25, 26, 28, and 32 hours after the application of the patch. Patch was then removed after the collection of 24 hour blood sample. AUC(0 -t) was based on the baseline adjusted nicotine plasma concentration data.|Baseline to 32 hours|Per Protocol Population, which consisted of all randomized participants who took at least one dose of the study treatment, did not have any protocol deviation, and provided enough pharmacokinetic data as determined by the pharmacokineticist.||nanogram (ng)*hour (hr)/milliliter (mL)||Standard Deviation|Mean
670249|NCT01702454|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|A serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|During the entire study period (Day 0 – Day 179)|Analysis was performed on the Total Vaccinated cohort included all subjects with at least one vaccine administration documented.||Subjects|||Number
670250|NCT01702454|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs.|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.|Within 28 days (Days 0-27) after first vaccination|Analysis was performed on the Total Vaccinated cohort included all subjects with at least one vaccine administration documented.||Subjects|||Number
670251|NCT01702454|Secondary|Number of Subjects Reporting Potential Immune-Mediated Diseases (pIMDs)|pIMDs were defined as a subset of AEs that included autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have had an autoimmune aetiology. Any pIMDs= Any AEs that occured regardless of the relation with vaccination. Related pIMDs= Any pIMD assessed by the investigator as casually related to the study vaccination.|During the entire study period (Days 0 - 179)|Analysis was performed on the Total Vaccinated cohort included all subjects with at least one vaccine administration documented.||Subjects|||Number
670252|NCT01702454|Secondary|Number of Subjects Reporting AEs With Medically Attended Visits (MAV)|MAVs were defined as an AEs with a medically-attended visits i.e. prompting emergency room (ER) visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. Any MAV was defined as at least one MAV experienced. Grade 3 was a MAV that prevented normal activities and related was defined as a MAV assessed by the investigator to be causally related to the study vaccination.|During the entire study period (Day 0 – Day 179)|Analysis was performed on the Total Vaccinated cohort included all subjects with at least one vaccine administration documented.||Subjects|||Number
670253|NCT01702454|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed were drowsiness, Irritability/Fussiness, loss of appetite and Temperature. Any Temperature = axillary temperature ≥37.5 degrees Celsius (°C). Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 Irritability/Fussiness = Crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = did not eat at all. Grade 3 temperature = axillary temperature > 39.0°C.|During the 7 days (Days 0 – 6) post dose 1 vaccination|Analysis was performed on the Total Vaccinated cohort included all subjects with at least one vaccine administration documented and symptom sheet completed.||Subjects|||Number
670254|NCT01702454|Secondary|Duration of Solicted Symptoms|Duration was defined as number of days with any grade of solicted local and/or general symptoms|During the 7-day (Days 0-6) post-vaccination Dose 1 period|Analysis was performed on the Total Vaccinated cohort included all subjects with at least one vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.||Days||Full Range|Median
670255|NCT01702454|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)|Solicited local AEs assessed were pain, redness and swelling. Any = any solicited local AE reported irrespective of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness and swelling was defined as redness/swelling above 50 millimeter (mm).|During a 7-day (Day 0 to 6) follow-up period after first vaccination|Analysis was performed on the Total Vaccinated cohort included all subjects with at least one vaccine administration documented and symptom sheet completed.||Subjects|||Number
670256|NCT01702454|Secondary|MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.|MGI was defined as the fold increase in GMTs post-vaccination compared to Day 0. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens. The humoral response in terms of anti-neuraminidase antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.|At Day 7 post dose 1|Analyses were performed on the ATP cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment, for whom the assay results for antibodies against at least one study vaccine strain after vaccination and for whom data concerning immunogenicity outcome measures were available||Fold Increase||95% Confidence Interval|Geometric Mean
670257|NCT01702454|Secondary|Vaccine Response Rate(VRR) for Anti-neuraminidase Antibody Titers Against Each of the Four Vaccine Strains by Age Strata.|VRR was defined as the percentage of vaccinees who had either a pre-vaccination titer <cut-off and a post-vaccination titer ≥ 4-fold of half of the cut-off or a pre-vaccination titer ≥cut-off and at least a 4-fold increase in post-vaccination titers. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria /361/2011(H3N2), B/Brisbane /60/2008(Victoria ) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens. The humoral response in terms of anti-neuraminidase antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.|At Day 7 post dose 1|Analyses were performed on the ATP cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment, for whom the assay results for antibodies against at least one study vaccine strain after vaccination and for whom data concerning immunogenicity outcome measures were available.||Subjects|||Number
670258|NCT01702454|Secondary|MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata|MGI was defined as the fold increase in GMTs post-vaccination compared to Day 0.The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.The humoral response in terms of neutralising antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.|At Day 7 post dose 1|Analyses were performed on the ATP cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment, for whom the assay results for antibodies against at least one study vaccine strain after vaccination and for whom data concerning immunogenicity outcome measures were available.||Fold Increase||95% Confidence Interval|Geometric Mean
670259|NCT01702454|Secondary|Vaccine Response Rate(VRR) for Serum Neutralising Antibody Titers Against Each of the Four Vaccine Strains by Age Strata|VRR was defined as the percentage of vaccinees who had either a pre-vaccination titer <cut-off and a post-vaccination titer ≥ 4-fold of half of the cut-off or a pre-vaccination titer ≥cut-off and at least a 4-fold increase in post-vaccination titers. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011(H3N2), B/Brisbane/60/2008(Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens. The humoral response in terms of neutralising antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.|At Day 7 post dose 1|Analyses were perfomed on the ATP cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment, for whom the assay results for antibodies against at least one study vaccine strain after vaccination and for whom data concerning immunogenicity outcome measures were available||Subjects|||Number
670260|NCT01702454|Secondary|Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata|Antibody titers were expressed as geometric mean titers. The vaccine strains included A/Christchurch/16/2010(H1N1), A/Victoria/361/2011(H3N2),B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009(Yamagata) antigens. The humoral response in terms of anti-neuraminidase antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.|At Day 0 and Day 7|Analyses were performed on the ATP cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment, for whom the assay results for antibodies against at least one study vaccine strain after vaccination and for whom data concerning immunogenicity outcome measures were available.||Titers||95% Confidence Interval|Geometric Mean
670261|NCT01702454|Secondary|Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.|Antibody titers were expressed as geometric mean titers. The vaccine strains included A/Christchurch/16/2010 (H1N1),A/Victoria/361/2011 (H3N2), A/Victoria/361/2011 and B/Hubei-Wujiagang/158/2009)(Yamagata) antigens. The humoral response in terms of neutralising antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.|At Day 0 and Day 7|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available||Titers||95% Confidence Interval|Geometric Mean
670262|NCT01702454|Secondary|MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine|MGI was defined as the fold increase in GMTs post-vaccination compared to Day 0. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 7 post dose 1|Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.||Fold increase||95% Confidence Interval|Geometric Mean
670263|NCT01702454|Secondary|Vaccine Response Rate(VRR) for Anti-neuraminidase Antibodies Against Each of the Four Vaccine Strains.|VRR was defined as the percentage of vaccinees who had either a pre-vaccination titer <cut-off and a post-vaccination titer ≥ 4-fold of half of the cut-off or a pre-vaccination titer ≥cut-off and at least a 4-fold increase in post-vaccination titers. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 7 post dose 1|Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.||Subjects|||Number
670264|NCT01702454|Secondary|MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.|MGI was defined as the fold increase in GMTs post-vaccination compared to Day 0. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 7 post dose 1|Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.||Fold Increase||95% Confidence Interval|Geometric Mean
670265|NCT01702454|Secondary|Vaccine Response Rate(VRR) for Serum Neutralising Antibody Titers Against Each of the Four Vaccine Strains|VRR was defined as the number of vaccinees who had either a pre-vaccination titer <cut-off and a post-vaccination titer ≥ 4-fold of half of the cut-off or a pre-vaccination titer ≥cut-off and at least a 4-fold increase in post-vaccination titers. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 7 post dose 1|Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.||Subjects|||Number
670266|NCT01702454|Secondary|Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine|NI (Neuraminidase inhibitor) antibody titers were expressed as geometric mean titers(GMTs).The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 0 and Day 7|Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.||Titer||95% Confidence Interval|Geometric Mean
670333|NCT01702233|Secondary|Changes From Baseline in ROM in Degrees (Active External Rotation in Abduction) After Visit 5 (Day 22), Traumeel vs Placebo|Range of movement (ROM) changes measured by active external rotation in abduction in degrees by goniometry in the range of 0 to 360 degrees.|Baseline vs. Day 22|||degrees||Standard Deviation|Mean
670267|NCT01702454|Secondary|Serum Micro Neutralizing(MN) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.|MN antibody titers were expressed as geometric mean titers(GMTs). The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 0 and Day 7|Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.||Titer||95% Confidence Interval|Geometric Mean
670268|NCT01702454|Secondary|Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.|The cut-off values assessed were less than (<) 1:10, 1:10 to < 1:40,≥ 1:40, ≥1:60 and ≥1:80 . The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 0 and Day 7|Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.||Subjects|||Number
670269|NCT01702454|Secondary|MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.|MGI was defined as the fold increase in serum HI GMT post-vaccination compared to Day 0. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 7 post dose 1|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.||Fold increase||95% Confidence Interval|Geometric Mean
670270|NCT01702454|Secondary|Vaccine Response Rate(VRR) for Anti-neuraminidase Antibody Titers Against Each of the Four Vaccine Strains.|VRR was defined as the number of vaccinees who had either a pre-vaccination titer <cut-off and a post-vaccination titer ≥ 4-fold of half of the cut-off or a pre-vaccination titer ≥cut-off and at least a 4-fold increase in post-vaccination titers. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 7 post dose 1|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.||Subjects|||Number
670271|NCT01702454|Secondary|MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.|MGI was defined as the fold increase in serum HI GMT post-vaccination compared to Day 0. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 7 post dose 1|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.||Fold increase||95% Confidence Interval|Geometric Mean
670272|NCT01702454|Secondary|Vaccine Response Rate (VRR) for Neutralising Antibody Titers Against Each of the Four Vaccine Strains.|VRR was defined as the number of vaccinees who had either a pre-vaccination titer <cut-off and a post-vaccination titer ≥ 4-fold of half of the cut-off or a pre-vaccination titer ≥cut-off and at least a 4-fold increase in post-vaccination titers. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 7 post dose 1|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.||Subjects|||Number
670273|NCT01702454|Secondary|Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine|Antibody titers were expressed as GMTs. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 0 and Day 7|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.||Titer||95% Confidence Interval|Geometric Mean
670274|NCT01702454|Secondary|Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine|Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 0 and Day 7|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.||Titer||95% Confidence Interval|Geometric Mean
670275|NCT01702454|Secondary|Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.|The cut-off values assessed were less than (<) 1:10, 1:10 to < 1:40 and ≥ 1:40. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 0 and Day 7|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.||Subjects|||Number
670351|NCT01701505|Secondary|Oxygen Saturation||At Baseline, 12 minutes, and 120 minutes|||percent||Standard Deviation|Mean
670352|NCT01701505|Secondary|Heart Rate||At Baseline, 12 minutes, and 120 minutes|||bpm||Standard Deviation|Mean
670276|NCT01702454|Primary|Number of Subjects Seroprotected for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.|Seroprotection rate was defined as the number of vaccinees with a serum HI titer greater than or equal to(≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011(H3N2), B/Brisbane/60/2008 (Victoria)and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 0 and Day 7|Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.||Subjects|||Number
670277|NCT01702454|Primary|Mean Geometric Increase (MGI) for HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.|Mean geometric increase was defined as the geometric mean of the within subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011(H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 7 post dose 1|Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.||Fold Increase||95% Confidence Interval|Geometric Mean
670278|NCT01702454|Primary|Number of Subjects Seroconverted for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.|A seroconverted subject was defined as a subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a four-fold increase in post-vaccination titer. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria)and B/Hubei-Wujiagang/158/2009 (Yamagata )antigens.|At Day 7 post dose 1|Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.||Subjects|||Number
670279|NCT01702454|Primary|Number of Subjects Seropositive for HI Antibody Titers Against Each of the Four Vaccine Strains After Dose 1 of Fluarix Quadrivalent Vaccine|Seropositivity was defined as number of subjects with antibody titers greater than or equal to (≥) 1:10. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 0 and Day 7|Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.||Subjects|||Number
670280|NCT01702454|Primary|Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.|Antibody titers were expressed as Geometric Mean Titers (GMTs). The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 0 and Day 7|Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.||Titers||95% Confidence Interval|Geometric Mean
670281|NCT01702454|Primary|Number of Subjects Seroprotected for Anti-HA Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.|Seroprotection rate (SPR) was defined as the number of vaccinees with serum haemagglutination inhibition (HI) titer ≥ 1:40 that usually is accepted as indicating protection in adults. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 0 and Day 7|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.||Subjects|||Number
670282|NCT01702454|Primary|Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.|MGI was defined as the fold increase in serum HI GMT post-vaccination compared to Day 0. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 7 post dose 1|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.||Fold increase||95% Confidence Interval|Geometric Mean
670283|NCT01702454|Primary|Number of Subjects Seroconverted for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.|A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 7 post dose 1|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.||Subjects|||Number
670284|NCT01702454|Primary|Number of Seropositive Subjects Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine|Seropositivity was defined as number of subjects with antibody titers greater than or equal to (≥) 1:10. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 0 and Day 7|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.||Subjects|||Number
670285|NCT01702454|Primary|Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine|Antibody titers were expressed as Geometric Mean Titers (GMTs). The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 0 and Day 7|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.||Titer||95% Confidence Interval|Geometric Mean
670286|NCT01702363|Secondary|Number of Participants With Abnormal Findings in 12-lead Electrocardiograms (ECG) at the Indicated Time Points|A 12-lead ECG was recorded in a supine position after the participant was kept at rest in this position for at least 5 minutes. Data are presented as clinically significant (CS) or not clinically significant (NCS) abnormal findings. An abnormal and significant ECG finding includes the presence of a QT interval corrected for heart rate (QTc interval) >500 milliseconds (msec) or an uncorrected QT interval >600 msec, for participants with Bundle Branch Block QTc >530 msec based on an average QTc value of triplicate ECGs. The study investigator determined if the abnormal ECG finding was CS or NCS. The WD Visit was conducted for participants who withdrew at any point during the study. The Week 24/WD and Week 52/WD Visits were conducted for participants who completed the Week 24 Visit or withdrew before Week 24 and completed the Week 52 Visit or withdrew before Week 52, respectively. The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).|BL (Screening Visit: Week -2), Week 12, Week 24,Week 36, Week 52, WD Visit, Week 24/WD Visit, and Week 52/WD Visit|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Participants|||Number
670287|NCT01702363|Secondary|Change From BL in Heart Rate Throughout the Treatment Period|Heart rate was measured in a sitting position after the participant was kept at rest for at least 5 minutes. Change from BL was calculated as the assessment value at the time of interest minus the BL value. The BL value was recorded at Week 0. The WD Visit was conducted for participants who withdrew at any point during the study. The Week 24/WD Visit was conducted for participants who completed the Week 24 Visit or withdrew before Week 24. The Week 52/WD Visit was conducted for participants who completed the Week 52 Visit or withdrew before Week 52.|BL (Week 0), Week 4, Week 8, Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD Visit, and Week 52/WD Visit|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters or at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||beats per minute||Standard Deviation|Mean
670288|NCT01702363|Secondary|Change From BL in Blood Pressure Throughout the Treatment Period|Blood pressure measurements included systolic blood pressure (SBP) and diastolic blood pressure (DBP). Blood pressure was measured in a sitting position after the participant was kept at rest for at least 5 minutes. Change from BL was calculated as the assessment value at the time of interest minus the BL value. The BL value was recorded at Week 0. The WD Visit was conducted for participants who withdrew at any point during the study. The Week 24/WD Visit was conducted for participants who completed the Week 24 Visit or withdrew before Week 24. The Week 52/WD Visit was conducted for participants who completed the Week 52 Visit or withdrew before Week 52.|BL(Week 0), Week 4, Week 8, Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD Visit, and Week 52/WD Visit|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters and at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||millimeters of mercury (mmHg)||Standard Deviation|Mean
670289|NCT01702363|Secondary|Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD|Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The Baseline value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).|BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters and at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Millimoles per Liter (MMOL/L)||Standard Deviation|Mean
670290|NCT01702363|Secondary|Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD|Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).|BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters and at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Micromoles per Liter (µM/L)||Standard Deviation|Mean
670316|NCT01702298|Primary|Change From Baseline in Fasting Plasma Glucose (FPG)|Change from baseline in FPG at Week 6 based on longitudinal data analysis (LDA) model including both baseline and post-baseline measurements as response variable and term time.|Baseline and Week 6|Full analysis set (FAS) defined as all participants who took at least one dose of study medication and had at least one baseline or post-baseline measurement.||mg/dL||95% Confidence Interval|Least Squares Mean
670291|NCT01702363|Secondary|Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD|Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).|BL (Screening Visit: Week -2), Week 12, Week 24, Week36, Week 52, WD Visit, Week 24/WD, and Week 52/WD|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters and at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||International Units per Liter (IU/L)||Standard Deviation|Mean
670292|NCT01702363|Secondary|Hematocrit Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD|Blood samples were collected for the measurement of hematocrit at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).|BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters and at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Proportion of red blood cells in blood||Standard Deviation|Mean
670293|NCT01702363|Secondary|Hemoglobin, Albumin, and Total Protein Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD|Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).|BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters and at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Grams per Liter (G/L)||Standard Deviation|Mean
670294|NCT01702363|Secondary|Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD|Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).|BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters and at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||10^9 cells per Liter (GI/L)||Standard Deviation|Mean
670295|NCT01702363|Secondary|Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL) (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD|Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD Visit (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD Visit (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).|BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD Visit, and Week 52/WD Visit|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters and at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Percentage of cells in blood||Standard Deviation|Mean
670296|NCT01702363|Primary|Number of Participants With AEs Classified by the Indicated Maximum Grade Severity Throughout the Treatment Period|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of the study medication, whether or not considered related to the study medication. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the study medication. AEs were classified according to intensity based upon the investigators' clinical judgment. The intensity was categorized as: mild (an event that is easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities); moderate (an event that is sufficiently discomforting to interfere with normal everyday activities); or severe (an event that prevents normal everyday activities).|From the first dose of study medication up to 52 weeks|ITT Population||Participants|||Number
670315|NCT01702298|Primary|Percentage of Participants Who Experienced at Least One Adverse Event|An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product.|Up to 8 weeks (including 14 days after final dose of study drug)|All participants treated population defined as all enrolled participants who received at least one dose of study treatment.||Percentage of participants||95% Confidence Interval|Number
670297|NCT01702363|Primary|Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) Throughout the Treatment Period|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of the study medication, whether or not considered related to the study medication. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the study medication. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect, or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, or is an event of possible drug-induced liver injury. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations.|From the first dose of study medication up to 52 weeks|Intent-to Treat (ITT) Population: All participants who received at least one dose of the study medication. For participants who withdrew from the study, all available data collected until the time of study discontinuation were included in the ITT analysis.||Participants|||Number
670298|NCT01702311|Secondary|Acute Renal Failure [Rise >50% of Baseline or Creatinine >2.5 mg/dl]|Acute renal failure [rise >50% of baseline or creatinine >2.5 mg/dl]|participants will be followed for the duration of hospital stay, an expected average of 6 days||||||
670299|NCT01702311|Secondary|Participants Will be Followed for the Duration of Hospital Stay, an Expected Average of 6 Days|Respiratory failure, defined as PaO2 value < 60 mm Hg while breathing air or a PaCO2 > 50 mm Hg|daily while in hospital for up to 10 days||||||
670300|NCT01702311|Secondary|Bacteremia|Bacteremia with SIRS/Sepsis|participants will be followed for the duration of hospital stay, an expected average of 6 days||||||
670301|NCT01702311|Secondary|Pneumonia|Pneumonia (CDC criteria)|participants will be followed for the duration of hospital stay, an expected average of 6 days||||||
670302|NCT01702311|Secondary|Nosocomial Infections (CDC)|Nosocomial infections during hospital stay as per the CDC criteria|participants will be followed for the duration of hospital stay, an expected average of 6 days||||||
670303|NCT01702311|Secondary|Hospital Mortality|Mortality is defined as death occurring during admission or during the hospital stay|participants will be followed for the duration of hospital stay, an expected average of 6 days||||||
670304|NCT01702311|Secondary|Length of Hospital Stay|Length of hospitalization|participants will be followed for the duration of hospital stay, an expected average of 6 days||||||
670305|NCT01702311|Secondary|Daily Dose of Insulin|Compare the daily dose of insulin used among both groups|participants will be followed for the duration of hospital stay, an expected average of 6 days||||||
670306|NCT01702311|Secondary|Number of Hypoglycemia (BG < 70 mg/dl) and Severe Hyperglycemia (BG>300 mg/dl)|Secondary outcomes include the number of hypoglycemia (BG < 70 mg/dl) and severe hyperglycemia (BG>300 mg/dl) among both the groups.|participants will be followed for the duration of hospital stay, an expected average of 6 days||||||
670307|NCT01702311|Secondary|Mean Daily BG and Number of BG Within Target|Secondary outcomes include differences between treatment groups in any of the following measures: mean daily BG and number of BG within target|participants will be followed for the duration of hospital stay, an expected average of 6 days||||||
670308|NCT01702311|Primary|Mean Fasting Blood Glucose|The primary outcome of the study is to compare differences in mean fasting blood glucose levels between patients receiving insulin supplements at bedtime compared to those without insulin supplementation.|up to 10 days|||mg/dL||Standard Deviation|Mean
670309|NCT01702298|Secondary|Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)|Change from baseline in HDL-C was measured as a percent change from baseline at Week 6 based on LDA model including percent change from baseline as response variable and term time.|Baseline and Week 6|FAS defined as all participants who took at least one dose of study medication and had both baseline and post-baseline measurements. One participant, who had no on-treatment data, was excluded from the FAS for the LDA analysis of HDL-C.||Percent change||95% Confidence Interval|Least Squares Mean
670310|NCT01702298|Secondary|Change From Baseline in Triglycerides (TG)|Change from baseline in TG was measured as a percent change from baseline at Week 6 (median and distribution free 95% confidence interval).|Baseline and Week 6|FAS defined as all participants who took at least one dose of study medication and had both baseline and post-baseline measurements. One participant, who had no on-treatment data, was excluded from the FAS.||Percent change||95% Confidence Interval|Median
670311|NCT01702298|Secondary|Change From Baseline in Non-high Density Lipoprotein Cholesterol (Non-HDL-C)|Change from baseline in non-HDL-C was measured as a percent change from baseline at Week 6 based on LDA model including percent change from baseline as response variable and term time.|Baseline and Week 6|FAS defined as all participants who took at least one dose of study medication and had both baseline and post-baseline measurements. One participant, who had no on-treatment data, was excluded from the FAS for the LDA analysis of non-HDL-C.||Percent change||95% Confidence Interval|Least Squares Mean
670312|NCT01702298|Secondary|Change From Baseline in Total Cholesterol (TC)|Change from baseline in TC was measured as a percent change from baseline at Week 6 based on LDA model including percent change from baseline as response variable and term time.|Baseline and Week 6|"FAS defined as all participants who took at least one dose of study medication and had both baseline and post-baseline measurements.
One participant, who had no on-treatment data, was excluded from the FAS for the LDA analysis of TC."||Percent change||95% Confidence Interval|Least Squares Mean
670313|NCT01702298|Secondary|Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)|Change from baseline in LDL-C was measured as a percent change from baseline at Week 6 based on LDA model including percent change from baseline as response variable and term time.|Baseline and Week 6|FAS defined as all participants who took at least one dose of study medication and had both baseline and post-baseline measurements. One participant, who had no on-treatment data, was excluded from the FAS for the LDA analysis of LDL-C.||Percent change||95% Confidence Interval|Least Squares Mean
670314|NCT01702298|Primary|Number of Participants Who Discontinued Study Drug Due to an Adverse Event|Participants who were discontinued from study drug due to an adverse event during the 6 weeks of treatment.|Up to 6 weeks|All participants treated population defined as all enrolled participants who received at least one dose of study treatment.||Participants|||Number
670353|NCT01701505|Secondary|Diastolic Blood Pressure||At Baseline, 12 minutes, and 120 minutes|||mmHg||Standard Deviation|Mean
670317|NCT01702259|Secondary|Patient Satisfaction With Study Outcome|"At completion of the treatment administration phase, the subject was asked to indicate how satisfied he or she was with any overall perceived change in the appearance of cellulite in his or her thighs and buttocks using the following five-point scale:
Very Satisfied Somewhat Satisfied Neither Satisfied nor Dissatisfied Not Very Satisfied Not at All Satisfied
Results are reported as the number of subjects who reported being 'Very Satisfied' or 'Somewhat Satisfied' with the study outcome."|2 Weeks|||participants|||Number
670318|NCT01702259|Secondary|Change in Percent (%) Body Surface Area (BSA) Covered by Cellulite.|The % Total Body Surface Area (% TBSA) covered by cellulite was marked and quantified according to the Lund and Browder Chart and methodology. The Lund and Browder chart is widely considered the most accurate method of determining Body Surface Area (BSA). It consists of an anterior and posterior diagram of a patient that is divided into sections. The % TBSA is the sum of the marked areas. The % TBSA of the buttocks and bilateral thighs area, front and back combined, affected by cellulite was calculated according to the Lund and Browder Chart.|Baseline and 2 weeks|The number of subjects analyzed for % TBSA covered by cellulite is less than the total number enrolled as this measure was not recorded for all subjects.||percentage of TBSA||Standard Deviation|Mean
670319|NCT01702259|Secondary|Change in Body Weight|Body weight is measured in pounds (lbs) using a digital scale.|Baseline and 2 weeks|||pounds||Standard Deviation|Mean
670320|NCT01702259|Secondary|Bilateral Upper Thigh Circumference Measurement|Circumference of the upper right and left thighs was recorded in inches (ins) using a flexible tape measure and the two measurements were summed, at baseline and 2 weeks. A decrease in bilateral upper thigh circumference measurements is positive in support of study success and an increase in bilateral circumference measurements is negative in support of study success.|Baseline and 2 weeks|||inches||Standard Deviation|Mean
670321|NCT01702259|Primary|Number of Subjects That Met the Individual Success Criteria|The individual subject success was defined as a decrease of one or more stages on the Nurnberger-Muller Scale (NMS) from baseline to 2 weeks post-assessment for both of the right and left thighs. The NMS is a four-stage scale used as an industry standard to classify stage or degree of cellulite and to determine change in stage or degree of cellulite following treatment intervention. The NMS ranges from Stage 0 (no cellulite) to Stage III (worse cellulite). A decrease in NMS Stage indicates reduced appearance of cellulite and is positive for study success. An increase in NMS Stage indicates worsened appearance of cellulite and is negative for study success. Overall study success was defined as 35% more subjects in the test group than in the control group attaining individual subject success. Results are reported below as the number of subjects in each group that met the individual subject success criteria.|Baseline and 2 weeks|||participants|||Number
670322|NCT01702246|Secondary|Change From Baseline in Total Cholesterol Level After Treatment With Simvastatin||Baseline and 3 months|change in baseline cholesterol level from baseline, after treatment with simvastatin||mmol/L||Standard Deviation|Mean
670323|NCT01702246|Secondary|Change in Plasma High Sensitivity C-reactive Protein|Mean difference in plasma high sensitivity C-reactive protein level, before and after treatment with simvastatin|Baseline and 3 months|||mg/mL||Standard Deviation|Mean
670324|NCT01702246|Primary|Change in Frequency of Vaso-occlusive Pain Events, Before and After Treatment With Simvastatin|The effect of simvastatin treatment will be assessed by measuring the difference from baseline in the mean frequency (and intensity) of vaso-occlusive pain events, after treatment with simvastatin. Pain rate (proportion of pain days) was defined as the number of days reported with sickle cell disease-related pain divided by the number of daily pain diaries completed.|Baseline and 3 months|||proportion of pain days||Standard Deviation|Mean
670325|NCT01702233|Secondary|Change From Baseline in DASH at Visit 7 (Day 105)|"The score from the questions answered on the DASH (Disaability of the Arm, Shoulder and Hand) questionnaire were evaluated on both shoulders at screening and on the The score consists of a basic questionnaire of 30 questions regarding the daily activities with the answer options from no difficulty (value 1) to unable (value 5).
The calculation is: ((sum of values of responses/number of responses)-1) X 25. Best possible result is 0, worst possible result is 100. The score may not be calculated if there are more than 3 missing answers.target shoulder at the later visits. Any changes between the score from baseline was used to evaluate efficacy"|Baseline vs. Day 105|||DASH score||Standard Deviation|Mean
670326|NCT01702233|Secondary|Change From Baseline in DASH at Visit 5 (Day 22)|"The score from the questions answered on the DASH (Disaability of the Arm, Shoulder and Hand) questionnaire were evaluated on both shoulders at screening and on the target shoulder at the later visits. Any changes between the score from baseline was used to evaluate efficacy.
The score consists of a basic questionnaire of 30 questions regarding the daily activities with the answer options from no difficulty (value 1) to unable (value 5).
The calculation is: ((sum of values of responses/number of responses)-1) X 25. Best possible result is 0, worst possible result is 100. The score may not be calculated if there are more than 3 missing answers."|Baseline vs. Day 22|||DASH score||Standard Deviation|Mean
670327|NCT01702233|Secondary|Painful Arc Test at Visit 5 (Day 22)|The amount of pain that disappeared by further abduction in the range between 60° and 120° was to be measured, with measurement of pain being positive/negative. The idea behind the test is the subacromial space in abduction becomes smaller, whereby compression of the rotator cuff and the subacromial bursa occurs (impingement test).|Baseline vs. day 22|||participants|||Number
670328|NCT01702233|Secondary|Jobe Test at Visit 5 (Day 22) With Measurement of Weakness|This test looked for pain and weakness and was to be examined as active movement. Patients have to stand with shoulders in 90 degrees of abduction, 30 degrees of forward flexion and then internally rotating arm completely i.e., thumb pointing down. This was done to see if the patient was able to resist the clinician’s attempts to depress the upper arm to look for muscle weakness.|Baseline vs. day 22|||participants|||Number
670329|NCT01702233|Secondary|Jobe Test at Visit 5 (Day 15) With Measurement of Pain|This test looked for pain and weakness and was to be examined as active movement. Patients have to stand with shoulders in 90 degrees of abduction, 30 degrees of forward flexion and then internally rotating arm completely i.e., thumb pointing down. This was done to see if the patient was able to resist the clinician’s attempts to depress the upper arm to look for muscle weakness.|Baseline vs. Day 22|||participants|||Number
670330|NCT01702233|Secondary|Changes From Baseline in ROM in Degrees (Active External Rotation in Abduction) After Visit 7 (Day 105), Traumeel vs Fortecortin|Range of movement (ROM) changes measured by active external rotation in abduction in degrees by goniometry in the range of 0 to 360 degrees.|Baseline vs. Day 105|||degrees||Standard Deviation|Mean
670334|NCT01702233|Secondary|Change From Baseline in Abduction Rotation Pain VAS for Active External Rotation – Comparison With Fortecortin at Visit 7 (Day 105)|VAS is a 100 mm visual analogue scale for measuring the pain resulted from the adbuction and external rotation of the arm. Possible scores range from 0 (no pain) to 100 (worst possible pain).|Baseline vs. day 105|||units on a scale, mm||Standard Deviation|Mean
670335|NCT01702233|Secondary|Change From Baseline in Abduction Rotation Pain VAS for Active External Rotation – Comparison With Placebo Visit 7 (Day 105)|VAS is a 100 mm visual analogue scale for measuring the pain resulted from the adbuction and external rotation of the arm. Possible scores range from 0 (no pain) to 100 (worst possible pain).|Baseline vs. Day 105|||units on a scale, mm||Standard Deviation|Mean
670336|NCT01702233|Secondary|Change From Baseline in Abduction Rotation Pain VAS for Active External Rotation – Comparison With Placebo Visit 5 (Day 22)|VAS is a 100 mm visual analogue scale for measuring the pain resulted from the adbuction and external rotation of the arm. Possible scores range from 0 (no pain) to 100 (worst possible pain).|Baseline vs. Day 22|||Change in mm baseline vs. day 22||Standard Deviation|Mean
670337|NCT01702233|Primary|Change From Baseline in Abduction Rotation Pain VAS at Visit 5 (Day 22) (Traumeel® S Injections Versus Fortecortin) for Active External Rotation|VAS is a 100 mm visual analogue scale for measuring the pain resulted from the adbuction and external rotation of the arm. Possible scores range from 0 (no pain) to 100 (worst possible pain). Change = (Day 22 score -- baseline score).|Baseline to Day 22|Per protocol population||units on a scale (mm)||Standard Deviation|Mean
670338|NCT01702025|Primary|Magnitude of Decrement in Exercise Time Trial Performance in Hypoxia (Low Oxygen) Compared With Normoxia (Normal Oxygen).|After exercising on a stationary cycle ergometer for 30 minutes at a resistance of 100 watts, research participants will complete an exercise time trial. The time taken to cycle a distance equivalent to 7.75 miles will be recorded. On a separate day the experiment will be repeated in hypoxia. It is expected that the time taken to cycle a distance equivalent to 7.75 miles will be longer in hypoxia compared to normoxia. One of the goals of this research is to determine if the hypoxia-mediated performance decrement can be decreased with one of our pharmacological interventions.|The exercise trial will begin within 5 hours of exposure to either normoxia or hypoxia|||minutes||Standard Error|Mean
670339|NCT01701999|Other Pre-specified|Collected Plasma Volume|Measurement of the volume of source plasma containing neutralizing antibodies against botulinum toxin type A and type B collected by plasmapheresis in Part 2.|Week 1 to Week 12|Participants in Part 1 were only analyzed for safety data, and one participant in Part 2 was excluded from plasma collection due to not meeting the plasma donor minimum weight requirement.||mL||Standard Deviation|Mean
670340|NCT01701999|Secondary|Two-Fold Increase in the Area Under the Neutralizing Antibody Concentration (NAC) Curve|Proportion of participants achieving a two-fold increase in the area under the plasma NAC-time curve between Week 0 and Week 12 in comparison with a straight-line extension of the Week 0 NAC to Week 12 for both botulinum toxin A and toxin B. A proportion ≥ 0.50 was considered a success.|Week 0 to Week 12|||proportion of participants|||Number
670341|NCT01701999|Secondary|Three-Fold Increase in Neutralizing Antibody Concentration (NAC)|Proportion of participants achieving a three-fold or greater increase in NAC up to Week 4 compared with Week 0 for both botulinum toxin A and toxin B (a proportion ≥ 0.50 was considered a success)|Week 0 to Week 4|||proportion of participants|||Number
670342|NCT01701999|Primary|Four-Fold Increase in Neutralizing Antibody Concentration (NAC)|Proportion of participants achieving a four-fold or greater increase in NAC up to Week 4 compared with Week 0 for both botulinum toxin A and toxin B (a proportion ≥ 0.50 was considered a success).|Week 0 to Week 4|||proportion of participants|||Number
670343|NCT01701674|Secondary|Progression Free Survival (PFS)|Progression-free survival (PFS), defined as the time from study entry to disease progression, relapse or death due to any cause, whichever is earlier, will be summarized with the Kaplan-Meier curve. Progressive Disease (PD): At least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|3 months||10/2017||||
670344|NCT01701674|Secondary|Overall Response Rate (ORR)|Overall response (OR) is defined as the participant being alive at week 6, confirmed at week 12 and tumor size evaluated at both times using the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria to be a complete response (CR) or partial response (PR). Evaluations will be made by computed tomography (CT) scan approximately 6 weeks after the cell infusion, then confirmed by CT scanning approximately 12 weeks after the cell infusion, and by clinical evaluation during the first 12 weeks. The overall response (CR+PR) rate will be summarized using both a point estimate and its exact confidence interval based on the binomial distribution.|3 months||10/2017||||
670345|NCT01701674|Primary|Rate of Meeting Feasibility Requirements|Number of participants who were successfully treated with at least 2 doses of ipilimumab and received TIL. Feasibility is defined as the ability to deliver at least 50% (i.e., two out of four) of the planned doses of ipilimumab and successfully treat at least 60% (i.e., ≥ 6/10) of the patients with TIL.|3 months|All participants||Participants|||Count of Participants
670346|NCT01701674|Primary|Occurrence of Dose Limiting Toxicity (DLT) Events|Occurrence of adverse events with dose limiting toxicity, per adverse event category.|3 months|All participants||DLT events|||Number
670347|NCT01701622|Secondary|If Patients With Hypertension Receive a Greater Reduction in Blood Pressure (BP) While on Febuxostat (Versus Allopurinol)|measured by mean 24-hour systolic blood pressure (SBP)/diastolic blood pressure (DBP), trough SBP/DBP, and mean nighttime SBP/SBP while on allopurionol and febuxostat.|Participants will be followed for an expected average of 4 to 5 weeks.||||||
670348|NCT01701622|Primary|BP Differences While on Allopurinol and Febuxostat by Clinic and Pressure Readings and 24-hour Ambulatory Blood Pressure Readings.|The following data will be collected: general demographic information, uric acid, casual blood pressure readings, 24-hour ambulatory blood pressure readings, including mean 24-hour systolic blood pressure (SBP)/diastolic blood pressure (DBP), trough SBP/DBP, and mean nighttime SBP/SBP while on allopurionol and febuxostat.|Participants will be followed for an expected average of 4 to 5 weeks.||||||
670349|NCT01701505|Secondary|Incidence of Adverse Events by Dose Level Regardless of Age||from baseline to 24 hours following drug administration|||Participants|||Count of Participants
670350|NCT01701505|Secondary|Number of Participants With Adverse Events by Dose Level and Age||from baseline to 24 hours following drug administration|Patients grouped by age||Participants|||Count of Participants
670355|NCT01701505|Secondary|Naris Examination (NE) to Assess Reactions to the Study Drug.|The principal investigator will perform a visual inspection to note number of participants at post-dose that have a ulceration, inflammation or minor bleeding.|At Baseline and 120 Minutes|||Participants|||Count of Participants
670356|NCT01701505|Primary|Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic.|If the participant does not have sufficient anesthesia to complete the Study Dental Procedure, the participant is given a rescue injection of local anesthetic and is considered a failure for this outcome.|at 14 minutes with a 3 minute window|||Participants|||Count of Participants
670357|NCT01701414|Primary|Number of Participants Reporting at Least One NRS Rating|Participants report their discomfort using a Numerical Rating Scale (NRS). Pain level is reported as 0 (lowest-no pain) to 10 (highest level of pain). Each patient enrolled in the study reported their level of pain at least once during their participation in the study.|30 minutes after the block is administered then every 60 minutes until discharge. Desired outcome was a low NRS rating.|||Participants|||Number
670358|NCT01701401|Secondary|Percentage of Participants With Virologic Failure|"On-treatment virologic failure was defined as:
Breakthrough: HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ, while on treatment, confirmed with 2 consecutive values (second confirmation value could have been posttreatment), or last available on-treatment measurement with no subsequent follow- up values, OR
Rebound: > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values (second confirmation value could have been posttreatment), or last available on-treatment measurement with no subsequent follow-up values, OR
Nonresponse: HCV RNA persistently ≥ LLOQ through 8 weeks of treatment
Virologic relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement"|Baseline to posttreatment Week 24|Full Analysis Set||percentage of participants|||Number
670359|NCT01701401|Secondary|Change From Baseline in HCV RNA at Week 8||Baseline; Week 8|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
670360|NCT01701401|Secondary|Change From Baseline in HCV RNA at Week 4||Baseline; Week 4|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
670361|NCT01701401|Secondary|Change From Baseline in HCV RNA at Week 2||Baseline; Week 2|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
670362|NCT01701401|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 8||Week 8|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants|||Number
670363|NCT01701401|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 4||Week 4|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants|||Number
670364|NCT01701401|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 2||Week 2|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants|||Number
670365|NCT01701401|Secondary|Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Study Drug|SVR4 and SVR24 were defined as HCV RNA level < LLOQ at 4 and 24 weeks after discontinuation of study drug, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set||percentage of participants|||Number
670366|NCT01701401|Primary|Incidence of Adverse Events Leading to Permanent Discontinuation From Any Study Drug|The percentage of participants who experienced an adverse event leading to permanent discontinuation from any study drug was summarized.|Up to 24 weeks|Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.||percentage of participants|||Number
670367|NCT01701401|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Study Drug (SVR12)|SVR12 was defined as HCV RNA level < the lower limit of quantification (LLOQ, ie, < 25 copies/mL) 12 weeks after last dose of study drug.|Posttreatment Week 12|Full Analysis Set: participants were randomized and received at least 1 dose of study drug.||percentage of participants|||Number
670368|NCT01701375|Secondary|To Determine the Maximal Tolerated Dose (MTD) of PD 0332991 in Timed Sequential Combination With Ara-C and Mitoxantrone|Dose escalation decisions will be based on nonhematologic toxicities in Cycle 1 (28 days) and hematologic toxicities, in the case of an aplastic marrow through Day 56, For cytopenias including ANC < 500/mm3 or platelets < 50, 000/mm3 a bone marrow will be performed between days 42 and 49.. Dose limiting toxicity (DLT) will be measured according to NCI-Common Terminology Criteria for Adverse Events (CTCAE) version 4.0|42 days||||||
670369|NCT01701375|Primary|The Toxicities of Administration of PD 0332991 in Combination With Cytarabine and Mitoxantrone.|The number of participants experiencing toxicities of administration of PD 0332991 in combination with cytarabine and mitoxantrone will be measured according to NCI-Common Terminology Criteria for Adverse Events (CTCAE) version 4.0|42 days|||participants|||Number
670370|NCT01701362|Secondary|Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥50%|Participants with at least 50% reduction in the mean pain score from baseline to each week. Weekly mean pain NRS scores are derived from the daily pain NRS and calculated as the mean of the available scores in the 7 days. Generally, week ’n’ mean pain score is defined as the mean of the 7 daily diary pain ratings from Day 2+7*(n-1) to Day 1+7*n. At least 4 entries within the last 7 days are required to calculate a mean score. Scores range from 0 (no pain) to 10 (worst possible pain), with higher scored indicating increased pain.|Week 15|ITT population: all randomized participants who took at least one dose of study drug||Percentage of participants|||Number
670371|NCT01701362|Secondary|Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥30%.|Participants with at least 30% reduction in the mean pain score from baseline to each week. Weekly mean pain NRS scores are derived from the daily pain NRS and calculated as the mean of the available scores in the 7 days. Generally, week ’n’ mean pain score is defined as the mean of the 7 daily diary pain ratings from Day 2+7*(n-1) to Day 1+7*n. At least 4 entries within the last 7 days are required to calculate a mean score. Scores range from 0 (no pain) to 10 (worst possible pain), with higher scored indicating increased pain.|Week 15|ITT population: all randomized participants who took at least one dose of study drug||Percentage of participants|||Number
670372|NCT01701362|Secondary|Percentage of Participants in MOS-SS With Optimal Sleep Status.|MOS-SS optimal sleep status analyzed on a scale of four parameters: any improvements, no change, any worsening and not applicable.|Week 15|ITT population: all randomized subjects who took at least one dose of study drug||Percentage of participants|||Number
670373|NCT01701362|Secondary|Mean Change From Baseline in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score.|"MOS-SS is a self administered measure consisting of twelve items that assess the key constructs of sleep. Instrument scored results in 7 subscales: sleep disturbance, snoring, awaken short of breath or with headache, quantity of sleep, optimal sleep, sleep adequacy, somnolence. Two index measures that assess sleep disturbance was also constructed to provide composite scores.
Sleep disturbance, snoring, somnolence, awaken short of breath, and the 9 items sleep problems index all have score ranges from 0 (no sleep problems) to 100 (greater sleep problems), therefore a negative change indicates improvement.
Sleep adequacy is scored 0 (least sleep adequacy) to 100 (better sleep adequacy), therefore a positive change indicates improvement.
Quantity of sleep is scored 0 (less quantity of sleep) to 24 (greater quantity of sleep), therefore a positive change indicates improvement.
Optimal sleep is scored Yes if average hours of sleep is in range of 7-8 hours."|Week 15|ITT population: all randomized participants who took at least one dose of study drug.||Units on a scale||95% Confidence Interval|Least Squares Mean
670374|NCT01701362|Secondary|Baseline Scores in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score.|"MOS-SS is a self administered measure consisting of twelve items that assess the key constructs of sleep. Instrument scored results in 7 subscales: sleep disturbance, snoring, awaken short of breath or with headache, quantity of sleep, optimal sleep, sleep adequacy, somnolence. Two index measures that assess sleep disturbance was also constructed to provide composite scores.
Sleep disturbance, snoring, somnolence, awaken short of breath, and the 9 items sleep problems index all have score ranges from 0 (no sleep problems) to 100 (greater sleep problems), therefore a negative change indicates improvement.
Sleep adequacy is scored 0 (least sleep adequacy) to 100 (better sleep adequacy), therefore a positive change indicates improvement.
Quantity of sleep is scored 0 (less quantity of sleep) to 24 (greater quantity of sleep), therefore a positive change indicates improvement.
Optimal sleep is scored Yes if average hours of sleep is in range of 7-8 hours."|Baseline|ITT population: all randomized participants who took at least one dose of study drug.||Units on a scale||Full Range|Median
670375|NCT01701362|Secondary|Change From Baseline to Endpoint in Quality of Life Using EuroQol (EQ-5D) Health State Profile Scores|A self-administered questionnaire designed to assess health related quality of life in terms of a single index value or utility score. There are 5 dimensions: mobility, self-care, usual activities, pain/ discomfort, and anxiety/ depression. Each dimension is rated on a 3 point response scale and the scores are combined to form a single index value between 0 and 1 with higher scores being more positive (better health status). The EQ-5D was completed by the subject at week-0 and week-15/ET where 30% responder and 50% responder status would be defined for each participants based on the percent change from baseline (week 0/Randomization) to each visit week in mean pain score and participant global impression of change (PGIC). PGIC is a self-administered instrument that measures change in participant’s overall status on a scale ranging from 1 (very much improved) to 7 (very much worse). It is based on the Clinical Global Impression of Change CGIC), which is a validated scale.|Week 15|ITT population: all randomized participants who took at least one dose of study drug||Units on a scale||Standard Error|Least Squares Mean
670376|NCT01701362|Secondary|Change From Baseline in Pain Interference Index (BPI-sf)|"BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during the 24 hour period prior to evaluation.
It consists of 7 sub-questions that evaluates the level of pain interference with daily functioning on 11-point response scales from 0 (does not interfere) to 10 (completely interferes).
The BPI-sf pain interference index was calculated as average of the seven individual pain interference scores."|Week 15|ITT population: all randomized participants who took at least one dose of study drug||units on a scale||Standard Error|Least Squares Mean
670377|NCT01701362|Secondary|Change From Baseline in Pain Severity Index (Brief Pain Inventory-short Form [BPI-sf])|A self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during the 24 hour period prior to evaluation. The BPI-sf consists of 5 questions. Four items measure pain on 11-point response scales from 0 (No Pain) to 10 (Pain as bad as you can imagine). In the above scale, score 0 indicates the better outcome whereas score 10 indicates the worse outcome.|Week 15|ITT population: all randomized participants who took at least one dose of study drug||units on a scale||Standard Error|Least Squares Mean
670378|NCT01701362|Secondary|Change From Baseline in Overall Weekly Mean Sleep Interference Score (SIRS)|"This is an 11-point NRS ranging from 0 (“pain does not interfere with sleep”) to 10 (pain completely interferes with sleep [unable to sleep due to pain]). Participants describe how pain has interfered with their sleep during the past 24 hours. Please note that the data for Baseline (raw scores) have been included in the below table to read the change from Baseline data in context.
Note: Weekly mean SIRS scores were derived from the daily sleep diary and calculated as the mean of the available scores in the 7 days. Generally, week ’n’ mean SIRS scores were defined as the mean of the 7 daily diary SIRS scores from Day 2+7 (n-1) to Day 1+7*n. For participants with multiple diary scores collected on the same day, the average of all non-missing scores for that day was used in any analyses or data listings.
Overall is the pooled average sleep interference score for each subject across all post-baseline/randomization weeks."|up to Week 15|ITT population: all randomized participants who took at least one dose of study drug||units on a scale||Standard Deviation|Mean
670379|NCT01701362|Secondary|Patient Global Impression of Change (PGIC) at Week 15|A self administered instrument that measures changes in participants’ overall status on a scale ranging from 1 (very much improved) to 7 (very much worse). The PGIC is based on the Clinical Global Impression of Change, which is a validated scale.|Week 15|ITT population: all randomized participants who took at least one dose of study drug||Participants|||Number
670380|NCT01701362|Primary|Change From Baseline to Week 15 in Weekly Mean Pain Score|This is based on the daily pain diary and is defined as the change from baseline to week 15 in mean pain diary score. The Daily Pain Diary consists of an 11-point numeric rating scale (NRS) ranging from 0 (“no pain”) to 10 (“worst possible pain”). Subjects describe their pain during the past 24 hours by choosing the appropriate number between 0 and 10.|up to Week 15|ITT population: all randomized participants who took at least one dose of study drug||units on a scale||Standard Error|Least Squares Mean
670408|NCT01701037|Secondary|Percent of Patients Completing Second and Third (Surgical) Biopsies|Biopsies will be assessed whether or not tissue is acquired at specified time points. Tissue is obtained through core, punch, incisional or excisional biopsy or surgical resection, based upon the clinical situation. Standard operating procedures for biopsies, sample preparation and analysis have been defined.|Up to 3 months|||percentage of participants|||Number
670381|NCT01701362|Primary|Baseline Mean Pain Score|This is based on the daily pain dairy and is defined as the baseline mean pain diary score. The Daily Pain Diary consists of an 11-point numeric rating scale (NRS) ranging from 0 (“no pain”) to 10 (“worst possible pain”). Subjects describe their pain during the past 24 hours by choosing the appropriate number between 0 and 10.|Baseline|Intent to Treat (ITT) population: all randomized participants who took at least one dose of study drug||units on a scale||Standard Deviation|Mean
670382|NCT01701271|Primary|Change of the Density of the Hair on a Polarized Light Video-camera as a Measure of Efficacy.|Number of hair was assessed for each participant with a polarized light video-camera every 15 days for a total of 6 assessments|baseline and 90 days|Good state of general health Suffering from hair loss No pharmacological treatment in progress Promise not to change the usual daily routine No atopy in the anamnesis||hairs/square inch||Full Range|Mean
670383|NCT01701271|Secondary|Change of Sebum on a Sebum-meter|Measurements checked and reported every 15 days of the decrease of existing sebum on the scalp of the volunteers with a sebum-meter.|baseline and 90 days|Good state of general health Suffering from hair loss||mg sebum/c^2||Full Range|Mean
670384|NCT01701271|Primary|Change of the Amount of Hair Loss in a Pull Test|"Measurement of the decrease of hair loss by pull test and pulling some hair with the fingers.
Measurements estimated and reported every 15 days. The Measure reports decrease in fallen hair"|baseline and 90 days|Good state of general health Suffering from hair loss No pharmacological treatment in progress Promise not to change the usual daily routine No atopy in the anamnesis||Fallen hair||Full Range|Mean
670385|NCT01701245|Secondary|EQ-5D-3L (EuroQoL 5 Questions and 3 Answering Levels) and a VAS (Visual Analogue Scale)|"The EQ-5D-3L (EuroQoL 5 questions and 3 answering levels) during the run-in period will be compared with the EQ-5D-3L during the treatment period. And treatment period will be compared to open label.
Rating of questions Level 1 no problems Level 2 some problems Level 3 Significant problems Worst case is 15 points and best case is 5 points using index
Visual analogue scale VAS 0-100 where 0 is the worst imaginable health state and 100 the best imaginable health state"|10 weeks (baseline 2 weeks, random 4 weeks and open label 4 weeks)|Changes between baseline and randomized period.Randomized period and open label. FAS Unmatched data.||units on a scale||Full Range|Mean
670386|NCT01701245|Secondary|Adverse Events|The frequency of device effects will be compared between the two treatment groups. Only effects which are new after baseline or have increased severity after baseline will be used in the comparison.|10 weeks|Safety population The Adverse Device effects are reported as Adverse Event, the device effects are AEs that are considered related to the treatment. Graded mild, moderate and severe||participants|||Number
670387|NCT01701245|Secondary|Pain Relief of Headache Attacks|"The median pain during baseline (2 weeks) will be compared with the last 14 days of the treatment period Scale 0-4 0= no pain
mild pain
moderate pain
severe pain
very severe pain"|baseline (2 weeks) and random period(last 2 weeks)|"Median severity per subject in run in period (14 days) and the last 14 Days in the treatment period.
FAS matched data set"||participants|||Number
670388|NCT01701245|Primary|A Change in the Frequency of Cluster Headache Attacks Per Week|The primary endpoint is the reduction in mean number of CH attacks per week. The number of CH attacks will be calculated as the sum of all attacks over the days in the run-in period and divided by the number of weeks, respectively for the last 14 days of treatment during the randomised phase. The reduction will then be the number of CH attacks during treatment period (last 14 days of the randomized treatment period) – number of CH attacks during run-in.|4 weeks|Full analysis set (FAS), matched group.||CH attacks per week||Standard Deviation|Mean
670389|NCT01701115|Secondary|Side Effects|Incidence of nausea|Postoperative Day 2|||Participants|||Count of Participants
670390|NCT01701115|Secondary|Duration of Analgesia|Time to pain|Postoperative Day 2|||minutes||95% Confidence Interval|Median
670391|NCT01701115|Secondary|Patient Readiness to Discharge||Participants will be followed every 15 minutes post-surgery until discharged from the hospital (up to 180 minutes)|||minutes||Standard Deviation|Mean
670392|NCT01701115|Primary|Handgrip Strength|The primary outcome will be handgrip strength as measured by a dynamometer. A reading will be obtained at baseline (before the interscalene block) and 60 minutes post-operative.|Difference between between baseline and postoperative.|||kg||Standard Deviation|Mean
670393|NCT01701102|Primary|Time From Spinal Administration to Block Regression to the S1 Dermatome in Post-Anesthesia Care Unit (PACU)|The time frame of the study for each patient only covers the period between time of surgery and time of discharge from the hospital, which is on the same day as the day of surgery|Participants will be followed for the duration of their recovery after surgery in the post-anesthesia care unit (PACU), an expected average of 2-4 hours.|||minutes||Inter-Quartile Range|Median
670394|NCT01701063|Secondary|Elimination Half-Life (T1/2) of Telaprevir|T1/2 was defined as the time required for the concentration or amount of drug in the body to be reduced by one-half.|Cohort 1: Pre-dose and 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, and 8.0 hours post-dose on Day 7, Cohort 2: Pre-dose and 0.5, 2.0, 4.0, 5.0, 6.0, and 8.0 hours post-dose on Day 7, Cohort 3: Pre-dose and 1.5, 4.0, and 8.0 hours post-dose on Day 7|Half life was not calculated because the calculation required the slope of terminal elimination phase and the PK sampling was relatively sparse and did not yield a terminal elimination phase from which half-life can be accurately estimated.|||||
670395|NCT01701063|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC) of Telaprevir|AUC was measured for telaprevir only. AUC 0-t last was defined as the area under the concentration-time curve from the time of dosing to the last measurable concentration. AUC 0-12 hour (AUC 0-12h) was calculated by respecifying predose concentrations as 12 hour concentrations. AUC 0-24h was calculated as AUC 0-12h multiplied by 2. Dose adjusted AUC (AUC 0-24h_Adj) was calculated by multiplying AUC 0-24h by the dose adjustment factor to obtain projected exposures in participants who were misdosed. Data were presented for AUC 0-t last, AUC 0-12h, AUC 0-24h, AUC 0-24h_Adj.|Cohort 1: Pre-dose and 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, and 8.0 hours post-dose on Day 7, Cohort 2: Pre-dose and 0.5, 2.0, 4.0, 5.0, 6.0, and 8.0 hours post-dose on Day 7, Cohort 3: Pre-dose and 1.5, 4.0, and 8.0 hours post-dose on Day 7|PK population. Here 'Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure.||hours*nanogram per milliliter (h*ng/mL)||Standard Deviation|Mean
670409|NCT01701037|Secondary|Investigational Agent Taken|Median number of pills taken|Up to 3 months|||Number of pills taken||Standard Deviation|Median
680685|NCT01566461|Secondary|All-cause Death||12 month|Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.||Percentage of participants|||Number
670396|NCT01701063|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Telaprevir|Tmax was measured for telaprevir only.|Cohort 1: Pre-dose and 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, and 8.0 hours post-dose on Day 7, Cohort 2: Pre-dose and 0.5, 2.0, 4.0, 5.0, 6.0, and 8.0 hours post-dose on Day 7, Cohort 3: Pre-dose and 1.5, 4.0, and 8.0 hours post-dose on Day 7|PK population. Here 'Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure.||hours (h)||Full Range|Median
670397|NCT01701063|Secondary|Maximum Plasma Concentration (Cmax) of Telaprevir|Cmax was measured for telaprevir only.|Cohort 1: Pre-dose and 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, and 8.0 hours post-dose on Day 7, Cohort 2: Pre-dose and 0.5, 2.0, 4.0, 5.0, 6.0, and 8.0 hours post-dose on Day 7, Cohort 3: Pre-dose and 1.5, 4.0, and 8.0 hours post-dose on Day 7|Pharmacokinetic (PK) population included all participants who received at least a single dose of telaprevir, whether the participant completed all treatments or not. Here 'Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
670398|NCT01701063|Secondary|Number of Participants With Telaprevir Resistant HCV Variant at Non-Structural Viral Protein 3-4A (NS3-4A) Region|Sequence analysis of the HCV NS3-4A region was performed to monitor telaprevir-resistant variants. HCV RNA was isolated from the plasma, amplified by reverse transcription-polymerase chain reaction (RT-PCR), and sequenced (sequencing assay limit of detection HCV RNA >=1000 IU/mL). Results of this outcome measure were to be reported for overall participants instead of by age.|Baseline, On treatment (up to Week 48)|FAS. Here ‘Number of Participants Analyzed’ signifies those participants who were evaluable for this outcome and ‘n’ signifies those who were evaluable at the specified time point.||participants|||Number
670399|NCT01701063|Secondary|Percentage of Participants With Virologic Relapse|The plasma HCV RNA level was measured using Roche COBAS TaqMan HCV/HPS RNA assay Version 2.0. The lower limit of quantification was 25 IU/mL. Viral relapse was defined as having detectable HCV at follow-up in participants who had HCV RNA less than (<) lower limit of quantification (LLOQ) at planned EOT.|12 weeks after planned EOT (up to Week 60)|FAS included all enrolled participants who received at least 1 dose of study drug. Here 'Number of Participants Analyzed' signifies those participants who completed the assigned treatment period and had undetectable HCV RNA at EOT.||percentage of participants|||Number
670400|NCT01701063|Secondary|Percentage of Participants With On-treatment Virologic Failure|On treatment virologic failure was defined as meeting any futility rule or completing assigned treatment duration and having detectable HCV RNA at EOT. The plasma HCV RNA level was measured using Roche COBAS TaqMan HCV/HPS RNA assay Version 2.0. The lower limit of quantification was 25 IU/mL. Futility rules: 1) HCV RNA >1000 IU/mL at Week 4; 2) HCV RNA >1000 IU/mL at Week 12; 3) Detectable HCV RNA after Week 12 to end of treatment.|Baseline up to Week 48|FAS included all enrolled participants who received at least 1 dose of study drug.||percentage of participants|||Number
670401|NCT01701063|Secondary|Percentage of Participants With Undetectable HCV RNA at Week 12|The plasma HCV RNA level was measured using Roche COBAS TaqMan HCV/HPS RNA assay version 2.0. The lower limit of quantification was 25 IU/mL.|Week 12|FAS included all enrolled participants who received at least 1 dose of study drug.||percentage of participants|||Number
670402|NCT01701063|Secondary|Percentage of Participants With Extended Rapid Virologic Response (eRVR)|The plasma HCV RNA level was measured using Roche COBAS TaqMan HCV/HPS RNA assay version 2.0. The lower limit of quantification was 25 IU/mL. eRVR was defined as an undetectable HCV RNA (<lower limit of quantification) at both 4 weeks and 12 weeks after the start of study treatment.|Week 4 and Week 12|FAS included all enrolled participants who received at least 1 dose of study drug.||percentage of participants|||Number
670403|NCT01701063|Secondary|Percentage of Participants With Rapid Virologic Response (RVR)|The plasma HCV RNA level was measured using Roche COBAS TaqMan HCV/HPS RNA assay version 2.0. The lower limit of quantification was 25 IU/mL. RVR was defined as an undetectable HCV RNA (<lower limit of quantification) 4 weeks after the start of study treatment.|Week 4|FAS included all enrolled participants who received at least 1 dose of study drug.||percentage of participants|||Number
670404|NCT01701063|Secondary|Percentage of Participants With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR24)|SVR24 was defined as an undetectable HCV RNA Levels (< lower limit of quantification) at 24 weeks after last planned dose of study drug. The plasma HCV RNA level was measured using Roche COBAS TaqMan HCV/HPS RNA assay version 2.0. The lower limit of quantification was 25 IU/mL.|24 weeks after last planned dose of study drug (up to Week 72)|SVR24 was not analyzed because study was terminated early and follow-up was conducted only up to 12 weeks after planned end of treatment (EOT).|||||
670405|NCT01701063|Secondary|Percentage of Participants With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12)|SVR12 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (less than [<] lower limit of quantification) at 12 weeks after last planned dose of study drug. The plasma HCV RNA level was measured using Roche COBAS TaqMan HCV/High Pure System (HPS) RNA assay version 2.0. The lower limit of quantification was 25 international units per milliliter (IU/mL).|12 weeks after last planned dose of study drug (up to Week 60)|Full analysis set (FAS) included all enrolled participants who received at least 1 dose of study drug.||percentage of participants|||Number
670406|NCT01701063|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|"AE: any adverse change from the participant's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Study drug includes all investigational agents administered during the course of the study."|Baseline up to Week 52|Safety set included all participants who received at least 1 dose of study drug.||participants|||Number
670407|NCT01701037|Secondary|Percentage of Biopsies With Adequate Tissue for Biomarker Analysis|Measured by the percent of tumor necrosis on hematoxylin and eosin stains; RNA gel electrophoresis, percent of adequate tissue for immunohistochemical stains in tissue microarray and cyTOF analysis.|Up to 3 months|||percentage of biopsies w/adequate tissue|||Number
670445|NCT01700387|Secondary|MEWT Score for Simple Reaction Time Sub-test at Visits 2-6 to Measure Mental Efficiency||12 Months||||||
670410|NCT01701037|Secondary|Number of Patients With Worst Grade Toxicities by Grade According to National Cancer Institute (NCI) CTCAE Version 4.0|"The intensity of the adverse event will be graded according to Version 4.0 of the National Cancer Institute Common Terminology Criteria for Adverse Events (June 14, 2010):
Grade 1 - Mild Grade 2 - Moderate Grade 3 - Severe or medically significant Grade 4 - Life-threatening Grade 5 - Death related to adverse event"|Up to 3 months|||participants|||Number
670411|NCT01701037|Secondary|Change in Tumor Volume Reduction in Participants With Intrinsic Resistance to B-RAF Targeted Therapy From Day 14 to Day 28.|Tumor volume reduction is calculated as the tumor volume change relative to the baseline measurement (percent). Change in tumor volume reduction from day 14 to day 28 is calculated as the difference of tumor volume reduction at day 28 and day 14. The median and Inter-Quartile Range are reported.|Day 14 and day 28|||percentage of reduction||Inter-Quartile Range|Median
670412|NCT01701037|Primary|Clinical Tumor Response Rate (Response is Based on Greater Than 30% Reduction From Baseline in Tumor Volume by RECIST Criteria) at Day 14.|Tumor response is defined as greater than 30% reduction from baseline in tumor volume by RECIST criteria. To determine whether a patient is responded at day 14, the patient must have the tumor volume evaluated at both baseline and day 14. The tumor response rate is calculated as the proportion of patients responded among all evaluated patients.|day 14|||proportion of responders||95% Confidence Interval|Number
670413|NCT01701024|Primary|Percent of Subjects With Two Grade Reduction From Baseline and Achieving Clear or Almost Clear||Baseline and 12 Weeks|||percentage of clear or almost clear|||Number
670414|NCT01701024|Primary|Percent of Subjects Who Have a Least a 2 Grade Reduction||Baseline and 12 Weeks|||Percent with >2% reduction|||Number
670415|NCT01701024|Primary|Absolute Change in Non-inflammatory Lesion Count||Baseline and 12 Weeks|||lesion count||Standard Deviation|Mean
670416|NCT01701024|Primary|Absolute Change in Inflammatory Lesion Count||Baseline and 12 Weeks|||Lesion count||Standard Deviation|Mean
670417|NCT01701011|Secondary|Depression|The Hospital Anxiety and Depression Scale (HADS) was used to measure general anxiety and depression (Zigmond and Snaith, 1983). TheHADSconsists of 14 items (7 items for each subscale) that are rated on a 4-point Likert scale. The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0 to 21). Scores on each scale can be interpreted in ranges: normal (0–7), mild (8–10), moderate (11–14) and severe (15–21) anxiety and depression.|T1 during the first week of the stimulation phase, T2 on the 10th day after embryo transfer, T3 six weeks after embryo transfer|Only in women with embryo transfer||units on a scale||Standard Error|Mean
670418|NCT01701011|Primary|Anxiety|The Hospital Anxiety and Depression Scale (HADS) was used to measure general anxiety and depression (Zigmond and Snaith, 1983). TheHADSconsists of 14 items (7 items for each subscale) that are rated on a 4-point Likert scale. The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0 to 21). Scores on each scale can be interpreted in ranges: normal (0–7), mild (8–10), moderate (11–14) and severe (15–21) anxiety and depression.|T1 during the first week of the stimulation phase, T2 on the 10th day after embryo transfer, T3 six weeks after embryo transfer|Only in women with embryo transfer||units on a scale||Standard Error|Mean
670419|NCT01700907|Secondary|The Incidence of Postoperative Delirium|The incidence of post operative delirium will be measured by Confusion Assessment Method (CAM) at baseline, 15mins, 3hrs, 6hrs, 12hrs, 24hrs, 48hrs postoperatively.|from 15 minutes to 48 hrs postoperatively|This is a pilot study.||participants|||Number
670420|NCT01700907|Secondary|Cognitive Function|Cognitive function will be measured by MMSE (Mini-Mental State Examination) at 24hrs pre and postoperatively. Total MMSE score is recorded by interview ranging from 0 (minimum) to 30 (maximum). MMSE score is consisted on 11 subscales, and total MMSE score is simply summation of all the subscale scores. Maximum MMSE score indicates that the patient is excellent for cognitive function. MMSE score under 26 indicated the cognitive dysfunction.|24 hrs pre and postoperatively|This is a pilot study||Scores on a scale||Inter-Quartile Range|Median
670421|NCT01700907|Secondary|The Time From the End of Anesthesia to Following Commands|When surgery ends, the fresh gas flow rate will be increased to 6L/min (100% oxygen). Patients will be asked to open eyes by touching the shoulder, calling the name every 15 seconds. Patients will be applied stimulus every 15 seconds until following commands. Extubation will be performed when the patient is judged to be awake and spontaneous breathing recovery substantially.|Within 60 minutes after the end of anesthesia|This is a pilot study.||second||Inter-Quartile Range|Median
670422|NCT01700907|Secondary|The Time From the End of Anesthesia to Eye Opening|When surgery ends, the fresh gas flow rate will be increased to 6L/min (100% oxygen). Patients will be asked to open eyes by touching the shoulder, calling the name every 15 seconds. Patients will be applied stimulus every 15 seconds until following commands. Extubation will be performed when the patient is judged to be awake and spontaneous breathing recovery substantially.|Within 60 minutes after the end of anesthesia|This is a pilot study.||second||Inter-Quartile Range|Median
670423|NCT01700907|Primary|The Time From the End of Anesthesia to Extubation|When surgery ends, the fresh gas flow rate will be increased to 6L/min (100% oxygen). Patients will be asked to open eyes by touching the shoulder, calling the name every 15 seconds. Patients will be applied stimulus every 15 seconds until following commands. Extubation will be performed when the patient is judged to be awake and spontaneous breathing recovery substantially.|Within 60 minutes after the end of anesthesia|This is a pilot study.||second||Inter-Quartile Range|Median
670424|NCT01700816|Secondary|Platelet Count|Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.|From admission to hospital to discharge, an expected average of 28 days post-transplant|8 participants were missing lab data in the bright light group, and 7 participants were missing lab data in the sham light group||thousand cells/uL||Inter-Quartile Range|Median
670425|NCT01700816|Secondary|Hematocrit (HCT)|Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.|From admission to hospital to discharge, an expected average of 28 days post-transplant|8 participants were missing lab data in the bright light group, and 7 participants were missing lab data in the sham light group||volume percentage (vol%) of red blood ce||Inter-Quartile Range|Median
670446|NCT01700387|Secondary|Subject's Headache Impact Test (HIT-6) Scores at Visits 2-6 to Measure Effect of Headache in Subject's Life||12 Months||||||
670426|NCT01700816|Secondary|Hemoglobin (HGB)|Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.|From admission to hospital to discharge, an expected average of 28 days post-transplant|8 participants were missing lab data in the bright light group, and 7 participants were missing lab data in the sham light group||g/dl||Inter-Quartile Range|Median
670427|NCT01700816|Secondary|White Blood Cells (WBC)|Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.|From admission to hospital to discharge, an expected average of 28 days post-transplant|8 participants were missing lab data in the bright light group, and 7 participants were missing lab data in the sham light group||K/uL||Inter-Quartile Range|Median
670428|NCT01700816|Secondary|Red Blood Cells (RBC)|Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.|From admission to hospital to discharge, an expected average of 28 days post-transplant|8 participants were missing lab data in the bright light group, and 7 participants were missing lab data in the sham light group||M/uL||Inter-Quartile Range|Median
670429|NCT01700816|Secondary|Serum Creatinine and Blood Urea Nitrogen (BUN)|Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.|From admission to hospital to discharge, an expected average of 28 days post-transplant|8 participants were missing lab data in the bright light group, and 7 participants were missing lab data in the sham light group||mg/dl||Inter-Quartile Range|Median
670430|NCT01700816|Secondary|Sodium (Na), Potassium (K), Chloride (Cl), and Carbon Dioxide (CO2)|Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT (Hematopoietic Stem Cell Transplantation).|From admission to hospital to discharge, an expected average of 28 days post-transplant|8 participants were missing lab data in the bright light group, and 7 participants were missing lab data in the sham light group||mmol/L||Inter-Quartile Range|Median
670431|NCT01700816|Secondary|Hospital Length of Stay||From admission to hospital to discharge, an expected average of 28 days post-transplant|One participant in the sham light arm was missing date of discharge, so only 18 hospital lengths of stay were able to be calculated in that arm.||days||Inter-Quartile Range|Median
670432|NCT01700816|Secondary|Average Dose of Antipsychotic Medications Required to Manage Delirium||From admission to hospital to discharge, an expected average of 28 days post-transplant|Only one case of delirium developed, and we did not collect data on antipsychotic medication use for this one participant.|||||
670433|NCT01700816|Secondary|Severity of Delirium Episodes: Memorial Delirium Assessment Scale (MDAS)|"Monday, Wednesday, and Friday assessments of the Memorial Delirium Assessment Scale (MDAS); Patients will receive assessments after beginning light therapy until day 28 post-transplant or discharge, whichever comes first.
10 item scale Items are rated on a four-point scale from 0 (none) to 3 (severe) depending on the level of impairment, rendering a maximum possible score of 30.
A score of 13 has been recommended as a cut-off for establishing the diagnosis of delirium"|From first documented episode of delirium until discharge from the hospital, assessed up to 28 days post-transplant|Only one case of delirium developed, and only an MDAS score was collected for this participant.||units on a scale|||Number
670434|NCT01700816|Primary|Number of Participants Who Developed Delirium Based on Meeting Criteria on the Delirium Rating Scale and/or Memorial Delirium Assessment Scale|Monday, Wednesday, and Friday assessments will begin after beginning light therapy and include the Delirium Rating Scale-Revised-98 (DRS-98)and Memorial Delirium Assessment Scale (MDAS)|From hospital admission until the date of first documented delirium, assessed up to 28 days post-transplant|Only 20 bright light therapy and 18 sham light participants were analyzed because 2 participants (one from each arm) only had one assessment. Consequently, no change could be documented to analyze change of delirium scales. They did not drop out; they just completed their transplant before more data could be gathered.||Participants|||Count of Participants
670435|NCT01700530|Secondary|Skeletal Muscle Mitochondrial Content (Citrate Synthase Enzyme Activity)|% change in skeletal muscle mitochondrial content (measured by citrate synthase enzyme activity) from pre to post intervention|12 weeks|||percent change||Standard Error|Mean
670436|NCT01700530|Primary|% Change in VO2max (Fitness)|% change in fitness between baseline and after 12 weeks of treatment will be assessed by VO2max|Change from Baseline to 12 weeks|Statins blocked exercise induced change in fitness||percentage change of VO2max||Standard Deviation|Mean
670437|NCT01700517|Primary|Postoperatory Analgesia After Total Knee Arthroplasty Comparing Femoral and Sciatic-femoral Block|"The objective of this article is to evaluate the effect of femoral and sciatic-femoral block using ultrasonography by the analog visual scale (AVS) of pain in postoperatory of patients submitted to TKA, opioid consumption and complications associated to anesthesics procedures.
To assure the double blindness, pain measurement was realized by the assistant author using a 10 points pain analog visual scale (0, absence of pain, and 10 the worst imaginable pain). Patient and researcher did not know at which group patient belongs. This measurement was realized during immediate pre-op, and 6, 12, 24 and 48 hours after surgery. After this the average of pain for each group was analyzed."|48 HOURS|This sample size was calculated for a fixed effects one-way analysis of variance design. It was assumed that the standard effect size (d) = 0.5, the level of alpha (two-tailed) = 0.05, and power = 0.8, resulting in twenty six patient. The sample was stratified, having 40 patients in each of three groups to compensate for expected dropouts||units on a scale||95% Confidence Interval|Mean
670438|NCT01700387|Secondary|Subject's Migraine Specific Quality of Life Questionnaire (MSQ) Scores at Baseline, 3, 6, 9 and 12 Months to Measure Subject's Quality of Life||12 Months||||||
670439|NCT01700387|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability||13 Months||||||
670440|NCT01700387|Secondary|Pharmacoeconomic Estimates on Number of Patients Needed to Treat (Randomize) to Have One Successful Patient at 3, 6, 9, and 12 Months.||12 Months||||||
670441|NCT01700387|Secondary|Subject Estimation of Compliance With Daily Topiramate||12 Months||||||
670442|NCT01700387|Secondary|MEWT Scores for Mathematical Processing Sub-test at Visits 2-6 to Measure Mental Efficiency||12 Months||||||
670443|NCT01700387|Secondary|MEWT Scores for Matching to Sample Sub-test at Visit 2-6 to Measure Mental Efficiency||12 Months||||||
670444|NCT01700387|Secondary|MEWT Score for Running Memory Continuous Performance Task Sub-test at Visits 2-6 to Measure Mental Efficiency||12 Months||||||
670450|NCT01700387|Primary|Physician Global Impression of Change (PGIC)|Score on Physician Global Impression of Change at Visits 3-6 (Day 113 and 365). Likert scale ranging from 1-7, where 1 = extremely worse and 7 = extremely better.|Collected on Visit 3 (Day 113), Visit 4 (Day 197), Visit 5 (281), and Visit 6 (Day 365)|Number of participants vary at each visit based on the number of those still enrolled in the study at the time of the visit.||units on a scale||Standard Deviation|Mean
670451|NCT01700387|Primary|Subject Global Impression of Change (SGIC)|Score on Subject Global Impression of Change at Visits 3-6 (Day 113 and 365). Likert scale ranging from 1-7, where 1 = extremely worse and 7 = extremely better.|Collected on Visit 3 (Day 113), Visit 4 (Day 197), Visit 5 (281), and Visit 6 (Day 365)|Number of participants vary at each visit based on the number of those still enrolled in the study at the time of the visit.||units on a scale||Standard Deviation|Mean
670452|NCT01700387|Primary|Subject Attrition Post Randomization|Count of subject attrition following randomization and reason for attrition (Consent withdrawn, Withdrawn due to adverse event, Lost to follow up)|Collected on Visit 2 (Day 29) through Visit 6 (Day 365)|||participants|||Number
670453|NCT01700348|Secondary|Percentage of Bleeding Sites|Compare the percentage of bleeding sites in Modified Gingival Index following 2 weeks of use of the Sonicare AirFloss + Manual Toothbrush versus the Control Group.|2 Weeks||||||
670454|NCT01700348|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Assess the safety of the Sonicare AirFloss + MTB treatment.|4 Months||||||
670455|NCT01700348|Secondary|Plaque|Compare plaque as measured by the reduction and percent reduction in Residual Protein Concentration (RPC) following 2 and 4 weeks of use of the Sonicare AirFloss + MTB and Control Group.|4 Weeks||||||
670456|NCT01700348|Secondary|Number of Bleeding Sites|Compare the number of bleeding sites in Modified Gingival Index following 2 weeks of use of the Sonicare AirFloss + Manual Toothbrush versus the Control Group.|2 Weeks||||||
670457|NCT01700348|Secondary|Gingival Inflammation|Evaluate the effect of the Sonicare AirFloss + MTB treatment on gingival inflammation as measured after 2 and 4 weeks versus baseline.|4 weeks||||||
670458|NCT01700348|Primary|The Effect of Sonicare AirFloss + MTB Treatment Versus the Control Group|The primary objective of the study is to compare the effect of Sonicare AirFloss + MTB treatment versus the Control Group on gingival inflammation (as measure by number of bleeding sites, and reduction in MGI) after four weeks of use.|Four Months||||||
670459|NCT01700335|Other Pre-specified|Maximum Tolerated Dose (MTD)|MTD was investigated with an index of DLT|Up to 16 weeks||||||Number
670460|NCT01700335|Secondary|Hematologic Improvement Effect (IWG 2006 Criteria, Responses Must be Sustained at Least 8 Weeks)|"Definition
Hematologic Improvement Erythrocyte (HI-E):
Hgb increase by >= 1.5 g/dL Relevant reduction of units of red blood cell (RBC) transfusions by an absolute number of at least 4 RBC transfusions/8 week compared with the pretreatment transfusion number in the previous 8 week. Only RBC transfusions given for a Hgb of <= 9.0 g/dL pretreatment will count in the RBC transfusion response evaluation
Hematologic Improvement Platelet (HI-P):
Absolute increase of >= 30×10^9/L for patients starting with > 20×10^9/L platelets Increase from < 20×10^9/L to > 20×10^9/L and by at least 100%
Hematologic Improvement Neutrophil (HI-N):
At least 100% increase and an absolute increase > 0.5×10^9/L
Progressive disease / Relapse:
At least 1 of the following:
At least 50% decrement from maximum response levels in granulocytes or platelets Reduction in Hgb by >= 1.5 g/dL Transfusion dependence"|Up to 60 weeks|||participants|||Number
670461|NCT01700335|Secondary|Hematologic Remission Effect (IWG 2006 Criteria, Responses Must be Sustained at Least 4 Weeks)|"Definition
Complete remission (CR) Bone marrow: <= 5% myeloblasts; normal maturation of all cell lines Peripheral blood: Hemoglobin (Hgb) >= 11 g/dL, Platelets >= 100×10^9/L, Neutrophils >= 1.0×10^9/L, Blasts 0%
Partial remission (PR) Same as CR criteria except bone marrow blasts decreased by >= 50% over pretreatment but still > 5%
Marrow CR Bone marrow: <= 5% myeloblasts and decrease by >= 50% over pretreatment Peripheral blood: will be noted in addition to marrow CR
Stable disease Failure to achieve at least PR, but no evidence of progression for > 8 wks
Disease progression
Patients with:
Less than 5% blasts: >= 50% increase in blasts to > 5% blasts 5%-10% blasts: >= 50% increase to > 10% blasts 10%-20% blasts: >= 50% increase to > 20% blasts 20%-30% blasts: >= 50% increase to > 30% blasts
Any of the following:
At least 50% decrement from maximum remission/response in granulocytes or platelets Reduction in Hgb by >= 2 g/dL Transfusion dependence"|Up to 60 weeks|||participants|||Number
670462|NCT01700335|Primary|Number of Participants Who Experienced Dose-limiting Toxicities (DLTs)|"A DLT was defined as adverse events for which a causal relationship with the investigational drug could not be ruled out and which met the following criteria that occurred by the final observation in Cycle 2. DLTs were also to be assessed in the Efficacy and Safety Assessment Committee.
Criteria:
Grade 3 or higher non-hematologic toxicity. However, nausea, vomiting, diarrhea, pyrexia, stomatitis, and esophagitis/dysphagia are excluded (Grade 3 nausea, vomiting, diarrhea, and pyrexia that cannot be controlled with antiemetic, antidiarrheal, or antifebrile agents are regarded as DLTs)
Grade 3 or higher stomatitis, esophagitis, and dysphagia that persist for >= 4 days"|Up to 60 weeks|||participants|||Number
670463|NCT01700192|Secondary|Average Allergic Rhinitis/Rhinoconjunctivitis Symptoms Assessed by Visual Analogue Scale (VAS) During Last 8 Weeks of Treatment|"Participants indicated the severity of symptoms in the past week on a VAS with a score range of 0 (no symptoms) to 100 (severe symptoms). Symptoms were assessed during 2 clinic visits occurring during the final 8 weeks of treatment (VAS score reflects the mean of 2 scores)."|Last 8 weeks of treatment (Weeks 44 to 52)|The analysis population consists of all randomized participants who received at least 1 dose of study drug and had data available.||Score on a Scale||Standard Deviation|Mean
670464|NCT01700192|Secondary|Average Total Combined Rhinoconjunctivitis Score (TCS) During Last 8 Weeks of Treatment|The TCS is the sum of the rhinoconjunctivitis DSS (rhinitis DSS and conjunctivitis DSS; range: 0 to 18) and the rhinoconjunctivitis DMS (rhinitis DMS and conjunctivitis DMS; range: 0 to 20); the total possible TCS ranges from 0 to 38 points with higher scores indicative of greater symptom severity. The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment.|Last 8 weeks of treatment (Weeks 44 to 52)|The analysis population consists of all randomized participants who received at least 1 dose of study drug and had data available.||Score on a Scale||Standard Deviation|Mean
670818|NCT01694771|Secondary|FVC AUC0-3h Response at 12 Weeks - Defined as Change From Baseline|Forced Vital Capacity (FVC) AUC0-3h response at 12 weeks - defined as change from baseline.|baseline and 12 weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation at 12 weeks.||L||Standard Error|Least Squares Mean
670465|NCT01700192|Secondary|Average Rhinitis Daily Medication Score (Rhinitis DMS) During Last 8 Weeks of Treatment|The Rhinitis DMS ranges from a score of 0 to 12 (higher scores indicative of greater symptomatic medication use). The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment.|Last 8 weeks of treatment (Weeks 44 to 52)|The analysis population consists of all randomized participants who received at least 1 dose of study drug and had data available.||Score on a Scale||Standard Deviation|Mean
670466|NCT01700192|Secondary|Average Rhinitis Daily Symptom Score (Rhinitis DSS) During Last 8 Weeks of Treatment|The Rhinitis DSS ranges from a score of 0 to 12 (higher scores indicative of greater symptom severity). The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment.|Last 8 weeks of treatment (Weeks 44 to 52)|The analysis population consists of all randomized participants who received at least 1 dose of study drug and had data available.||Score on a Scale||Standard Deviation|Mean
670467|NCT01700192|Primary|Number of Participants Who Discontinue Study Drug Due to an AE|An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 52 weeks|The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).||Participants|||Number
670468|NCT01700192|Primary|Number of Participants Who Experience At Least One Adverse Event (AE)|An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 54 weeks|The All Participants as Treated (APaT) population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).||Participants|||Number
670469|NCT01700192|Primary|Average Total Combined Rhinitis Score (TCRS) During Last 8 Weeks of Treatment|The TCRS is the sum of the rhinitis Daily Symptom Score (DSS; range: 0 to 12) and the rhinitis Daily Medication Score (DMS; range: 0 to 12); the total possible TCRS ranges from 0 to 24 points with higher scores indicative of greater symptom severity. The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment.|Last 8 weeks of treatment (Weeks 44 to 52)|The analysis population consists of all randomized participants who received at least 1 dose of study drug and had data available.||Score on a Scale||Standard Deviation|Mean
670470|NCT01700179|Primary|SVR12|To determine the incidence of a sustained virologic response at 12 weeks after the completion of dosing (SVR12) with ACH-0143102 plus ribavirin, reported as HCV RNA less than the limit of quantification (<LOQ) at that time point|12 weeks following last dose|||percentage of subjects|||Number
670471|NCT01700140|Secondary|Skin Manifestations at Study Drug Application Site|"The investigator or sub-investigator recorded skin manifestations observed after removal of the study drug.
Skin manifestations were counted for each type of patches (placebo patch, SyB D-0701 15 cm2 patch, SyB D-0701 25 cm2 patch)."|Up to 192 hours|"Skin manifestations were counted for each type of patch applied to the subjects in the safety population.
Placebo patch : 60-1+63+60=182 (One subject in placebo group did not applied 15 cm2 patch.)
SyB D-0701 15 cm2 patch : 62
SyB D-0701 25 cm2 patch : 62+63=125"||Number of events|||Number
670472|NCT01700140|Secondary|Severe (Grade 3 or More) Adverse Events|"The severity of AEs were graded on a 5-point scale (Grade 1 to 5) according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe or medically significant but not immediately life-threatening, Grade 4: Life-threatening consequences, Grade 5: Death related to AE"|Up to 192 hours|"Safety population:
The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment."||Number of events|||Number
670473|NCT01700140|Secondary|Adverse Events|Adverse event is any untoward medical occurrence experienced by a subject irrespective of causal relationship with the study drug, and includes the unexpected signs, clinically significant fluctuations of laboratory data, and aggravation of disease, symptoms or complications. Adverse events are coded using the preferred terms (PT) of Medical Dictionary for Regulatory Activities (MedDRA) version 15.0.|Up to 192 hours|"Safety population:
The safety population consisted of all subjects enrolled, except for subjects with Good Clinical Practice (GCP) non-compliance and those who failed to receive the study treatment."||Participants|||Number
670474|NCT01700140|Secondary|Complete Response Rate Within 24 Hours After Each Irradiation From Sessions 1 to 3|"Complete response rate within 24 hours after each irradiation, from the first to the third fraction of radiotherapy.
The complete response rate was defined as the percentage of subjects who had no emesis and who used no rescue drugs."|24-72 hours|"Per protocol set:
Of all the randomized subjects, those who were compliant with the protocol were included in the per protocol set."||Percentage of participants|||Number
670475|NCT01700140|Secondary|Complete Control Rate Within 24 Hours After Each Irradiation From Sessions 1 to 3|"Complete control rate within 24 hours after each irradiation, from the first to the third fraction of radiotherapy.
The complete control rate was defined as the percentage of subjects who had no emesis and no moderate or more severe nausea and who used no rescue drugs."|24-72 hours|"Per protocol set:
Of all the randomized subjects, those who were compliant with the protocol were included in the per protocol set."||Percentage of participants|||Number
670476|NCT01700140|Secondary|Time to First Nausea|Time from the start of radiotherapy to the onset of first nausea. The median (50% point) of time to first nausea was estimated.|24-72 hours|"Per protocol set:
Of all the randomized subjects, those who were compliant with the protocol were included in the per protocol set."||Hours||95% Confidence Interval|Median
670477|NCT01700140|Secondary|Time to First Emesis|Time from the start of radiotherapy to the onset of first emesis. The median (50% point) of time to first emesis was estimated.|24-72 hours|"Per protocol set:
Of all the randomized subjects, those who were compliant with the protocol were included in the per protocol set."||Hours||95% Confidence Interval|Median
670478|NCT01700140|Secondary|Complete Response (no Signs of Emesis and no Use of Rescue Medication) Rate From the Start of Radiotherapy Until 24 Hours After the Third Irradiation|The complete response rate was defined as the percentage of subjects who had no emesis and who used no rescue drugs during the period from the time of the first irradiation to 24 hours after the third irradiation.|72 hours|"Per protocol set:
Of all the randomized subjects, those who were compliant with the protocol were included in the per protocol set."||Percentage of participants|||Number
670479|NCT01700140|Primary|Complete Control (no Signs of Emesis or Moderate to Severe Nausea and no Use of Rescue Medication) Rate From the Start of Radiotherapy Until 24 Hours After the Third Irradiation|The complete control rate was defined as the percentage of subjects who had no emesis and no moderate or more severe nausea and who used no rescue drugs during the period from the time of the first irradiation to 24 hours after the third irradiation.|72 hours|"Per protocol set:
Of all the randomized subjects, those who were compliant with the protocol were included in the per protocol set."||Percentage of participants|||Number
670480|NCT01699867|Primary|Number of Margins With False Positive Device Readings||one week after surgery|Patients with all negative margins (≥ 2 mm). On average, 5 out of 6 possible margins were analyzed per patient.||False positive margins per patient||Standard Deviation|Mean
670481|NCT01699867|Primary|Patients With All Positive Margins Correctly Identified With the Device|"In this study, a patient had positive margins if tumor was identified at the true margin (i.e., the final margin or new margin) surface of at least one specimen by histology (0 mm, tumor on ink)."|one week after surgery|"Patients with positive margins (0 mm, tumor on ink)."||Patients w/ all positives identified|||Number
670482|NCT01699815|Other Pre-specified|Average Length of Stay (LOS)|To compare patient length of stay (LOS) between groups as measured by day of discharge minus day of admission.|Baseline to discharge (1-4 days)|||days||Standard Deviation|Mean
670483|NCT01699815|Secondary|Pain Medication Consumption Rates|Number of participants who required rescue pain medication. Rescue pain medications is defined as administration of pain medication in excess of standard postoperative pain medication orders.|Arrival to post-anesthesia care unit (PACU or recovery room) (2-3 hours post baseline) to 24 hours post administration of study drug|||participants|||Number
670484|NCT01699815|Primary|Changes in Postoperative Pain Scores|To compare analgesic efficacy as measured by changes in postoperative pain scores assessed preoperatively, at 6, 12, 18, and 24 hours following the initial administration of the study drug. Pain scores are assessed on a scale of 0 - 10. 0 = No Pain; 10 = Worst Possible Pain|preoperatively (baseline), post-anesthesia care unit (PACU or recovery room) arrival (2-3 hour), and 6,12, 18, and 24 hours following the initial administration of the study drug|||units on a scale||Standard Deviation|Mean
670485|NCT01699789|Secondary|Park or Community Center Visits With Depression Service if Went to Park or Community Center||6 months follow-up|||percentage of participants||95% Confidence Interval|Mean
670486|NCT01699789|Secondary|Faith-based Visits With Depression Service if Faith Participation|For this sector, depression/mental health service is defined by client report of having assessment, counseling, education, medication discussion or referral for depression or emotional or mental health problems.|6 months follow-up|||percentage of patients||95% Confidence Interval|Mean
670487|NCT01699789|Secondary|Medication Visits Among MHS Users||6 months follow-up|||percentage of participants||95% Confidence Interval|Mean
670488|NCT01699789|Secondary|>= 2 PCP Visits With Depression Services, if Any||6 months follow-up|||percentage of participants||95% Confidence Interval|Number
670489|NCT01699789|Secondary|>=2 Emergency Room Visits||6 months follow-up|||percentage of participants||95% Confidence Interval|Number
670490|NCT01699789|Secondary|>=4 Hospital Nights for Behavioral Health||6 months follow-up|||percentage of participants||95% Confidence Interval|Number
670491|NCT01699789|Secondary|Any Missed Work Day in Last 30 Days, if Working||6 months follow-up|||percentage of participants||95% Confidence Interval|Number
670492|NCT01699789|Secondary|Working for Pay||6 months follow-up|||percentage of participants||95% Confidence Interval|Number
670493|NCT01699789|Secondary|My Life is Organized||6 months follow-up|||percentage of participants||95% Confidence Interval|Number
670494|NCT01699789|Secondary|Total Outpatient Contacts for Depression|Total outpatient contacts for depression, mental health or substance abuse from emergency rooms, primary care or public health, mental health, substance abuse, or social-community services sectors|12 months follow-up|||mean number of visits||95% Confidence Interval|Number
670495|NCT01699789|Secondary|Total Outpatient Contacts for Depression|Total outpatient contacts for depression, mental health or substance abuse from emergency rooms, primary care or public health, mental health, substance abuse, or social-community services sectors|6 months follow-up|||mean number of visits||95% Confidence Interval|Mean
670496|NCT01699789|Secondary|Took Antidepressant 2 Months or More in Past 6 Months|Took antidepressant two months or more past 6 months, %|12 months follow-up|||percentage of participants||95% Confidence Interval|Number
670497|NCT01699789|Secondary|Took Antidepressant 2 Months or More in Past 6 Months|Took antidepressant two months or more past 6 months, %|6 months follow-up|||percentage of participants||95% Confidence Interval|Number
670498|NCT01699789|Secondary|Use of Park or Community Centers|Any use of parks or community centers, %|12 months follow-up|||percentage of participants||95% Confidence Interval|Number
670499|NCT01699789|Primary|PHQ-9 Score ≥ 10|Mild/moderate depression defined as PHQ-9 score ≥ 10.|6 months follow-up|||percentage of participants||95% Confidence Interval|Number
670500|NCT01699789|Secondary|Use of Park or Community Centers|Any use of parks or community centers, %|6 months follow-up|||percentage of participants||95% Confidence Interval|Number
670501|NCT01699789|Secondary|Faith-based Program Participation|Any faith-based program participation, %|12 months follow-up|||percentage of participants||95% Confidence Interval|Number
670502|NCT01699789|Secondary|Faith-based Program Participation|Any faith-based program participation, %|6 months follow-up|||percentage of participants||95% Confidence Interval|Number
670503|NCT01699789|Secondary|PCP Visit With Depression Service|Any primary care visit with depression service, %|12 months follow-up|||percentage of participants||95% Confidence Interval|Number
670504|NCT01699789|Secondary|PCP Visit With Depression Service|Any primary care visit with depression service, %|6 months follow-up|||percentage of participants||95% Confidence Interval|Number
670505|NCT01699789|Secondary|MHS Outpatient Visit|Any mental health outpatient visit, %|12 months follow-up|||percentage of participants||95% Confidence Interval|Number
670506|NCT01699789|Secondary|MHS Outpatient Visit|Any mental health outpatient visit, %|6 months follow-up|||percentage of participants||95% Confidence Interval|Number
670507|NCT01699789|Secondary|Hospitalization for Behavioral Health|Any hospitalization for alcohol, drug, mental health, %|12 months follow-up|||percentage of participants||95% Confidence Interval|Number
670509|NCT01699789|Primary|Poor Mental Health Quality of Life, MCS12≤ 40|From the Short Form, 12-item quality of life measure, mental health-related quality of life is the primary client outcome. Poor mental health related quality of life is defined as MCS12≤ 40 (one standard deviation below population mean).|12 months follow-up|||percentage of participants||95% Confidence Interval|Number
670510|NCT01699789|Secondary|Homeless or ≥ 2 Risk Factors for Homelessness|Being homeless or having no place to stay for 2 nights or more; food insecurity; eviction from primary place of residence; or major financial crisis from items in client surveys. Homeless/shelter (pure, demo306=7) or >=2 risk factor for homelessness out of 4 items diff1 diff2 diff11 diff6)|6 months follow-up|||percentage of participants||95% Confidence Interval|Number
670511|NCT01699789|Secondary|Physically Active|Items on physical activity that are self-reported in the client survey, drawn from the SF-12 and measures of exercise and physical activity. how physically active you are (cond606>=3), 1=Quite/very/extreme active, %|6 months follow-up|||percentage of participants||95% Confidence Interval|Number
670512|NCT01699789|Secondary|Mental Wellness|Mental Wellness, % (at least good bit of time on 3 items on feeling peaceful or, calm, been a happy person, having energy), at least 1 item out of 3.|6 months follow-up|||percentage of participants||95% Confidence Interval|Number
670513|NCT01699789|Primary|Poor Mental Health Quality of Life, MCS12≤ 40|From the Short Form, 12-item quality of life measure, mental health-related quality of life is the primary client outcome. Poor mental health related quality of life is defined as MCS12≤ 40 (one standard deviation below population mean).|6 months follow-up|||percentage of participants||95% Confidence Interval|Number
670514|NCT01699763|Secondary|MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) in the High Glucose Range (>180 mg/dL)|"Using samples with YSI plasma Blood Glucose (BG) >180 mg/dL, the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI subject plasma results (BG reference) were compared. MARD is calculated from the sum of all |(BG meter)-(BG reference)|/(BG reference) assessments, divided by the number of assessments, then multiplied by 100(%). Each evaluable sample was tested on all 3 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD value indicates smaller difference between meter value and the reference value. Higher MARD value indicates larger difference between meter value and the reference value."|8 hours|Same number (106) of BG results was possible for each BGMS. Staff collected 3 capillary samples from each subject (total 333), of which 106 samples were greater than 180 mg/dL.||Percent Difference|Participants|Standard Error|Mean
670515|NCT01699763|Secondary|MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) in the Low Glucose Range (<=80 mg/dL)|"Using fresh and glycolyzed samples with YSI plasma Blood Glucose (BG) ≤80 mg/dL, the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI subject plasma results (BG reference) were compared. MARD is calculated from the sum of all |(BG meter)-(BG reference)|/(BG reference) assessments, divided by the number of assessments, then multiplied by 100(%). Each evaluable sample was tested on all 3 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD value indicates smaller difference between meter value and the reference value. Higher MARD value indicates larger difference between meter value and the reference value."|8 hours|Same number (107) of BG results was possible for each BGMS. Staff collected 3 capillary samples from each subject (total 333), of which 107 samples were less than or equal to 80 mg/dL.||Percent Difference|Participants|Standard Error|Mean
670516|NCT01699763|Primary|MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Overall Tested Glucose Range|"Using the overall Blood Glucose (BG) range (34 to 561 mg/dL according to YSI subject plasma results), the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI plasma results (BG reference) were compared. MARD is calculated from the sum of all |(BG meter)-(BG reference)|/(BG reference) assessments, divided by the number of assessments, then multiplied by 100(%). Each evaluable sample was tested on all 3 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD value indicates smaller difference between meter value and the reference value. Higher MARD value indicates larger difference between meter value and the reference value."|8 hours|Same number 333 (336-3) BG results possible for each BGMS. Staff collected 3 capillary samples from each subject - total 336 samples. Three samples from one subject were not analyzed. Subject hematocrit (58.5) was above the study evaluable limit of 55.||Percent Difference|Participants|Standard Error|Mean
670517|NCT01699750|Secondary|Minimum Protected Area|Minimum protected area (i.e., minimum area of the lens (%) covered by the tear film during the interblink period) was measured using a diffuse illumination source (Tearscope) and videotography. A higher value indicates a larger area of the tearfilm spread evenly over the lens (i.e., less area of tear film breakage). One eye (study eye) contributed to the mean.|Day 30|This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy endpoint. Two Day 30 measurements per participant (one eye per Day 30) contributed to analysis.||percentage of lens surface covered||Standard Deviation|Mean
670518|NCT01699750|Secondary|Average Exposure Speed|Exposure speed (rate of increase in exposed lens surface % (areas not protected by tear film) after the first tear film break and before the second blink) was measured with a diffuse illumination source (Tearscope) and videotography. Higher speeds indicate worse tear film dynamics. One eye (study eye) contributed to the mean.|Day 30|This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy endpoint. Two Day 30 measurements per participant (one eye per Day 30) contributed to analysis.||percent of area exposed/second||Standard Deviation|Geometric Mean
670519|NCT01699750|Secondary|Overall Dryness Measured With Visual Analog Scale (VAS)|The participant rated overall dryness on a 100-millimeter analog scale by marking a line that best describes how dry their eyes feel (0=not at all dry, 100=very dry). Both eyes were rated together as a single, retrospective evaluation of the previous 3 days of wear.|Day 30|This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy endpoint.||units on a scale||Standard Deviation|Mean
670520|NCT01699750|Secondary|Overall Comfort Measured With Visual Analog Scale (VAS)|The participant rated overall comfort on a 100-millimeter analog scale by marking a line that best corresponds to their eye comfort (0=very poor, 100=excellent). Both eyes were rated together as a single, retrospective evaluation of the previous 3 days of wear.|Day 30|This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy endpoint.||units on a scale||Standard Deviation|Mean
670521|NCT01699750|Secondary|LogMAR Time-Controlled Visual Acuity (TCVA)|Visual performance was measured binocularly (both eyes together) at two contrast levels using a validated Time Controlled Visual Acuity test (TCVA). TCVA was recorded in VA units (1 VA unit=1 VA line=0.1 logMAR), with positive (+) values corresponding with VA better than 20/20 and negative (-) values worse than 20/20.|Day 30|This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy. Two Day 30 measurements per participant contributed to analysis.||VA unit||Standard Deviation|Mean
670522|NCT01699750|Secondary|Mean Non-Invasive Pre-Lens Tear Film Break Up Time (NIBUT)|The pre-lens tear film is the layer of tears located on top of the contact lens between the eyelid and the contact lens. NIBUT (i.e., the time elapsed between eye opening after a blink and the appearance of the first dark spot within the tear film) was measured using a diffuse illumination source (Tearscope) and videotography. A longer NIBUT indicates a more stable tear film and greater on-eye lens wettability. One eye (study eye) contributed to the mean.|Day 30|This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy endpoint. Two Day 30 measurements per participant (one eye per Day 30) contributed to analysis.||seconds||Standard Deviation|Geometric Mean
670523|NCT01699750|Primary|Mean Ex-Vivo Total Lipid Uptake Per Lens|The contact lens was aseptically removed from the eye. Lipids were extracted and analyzed using a proprietary High Performance Liquid Chromatography technique. A lower value indicates a cleaner lens surface. One eye (study eye) contributed to the mean.|Day 30|This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy endpoint. Two Day 30 measurements per participant (one eye per Day 30) contributed to analysis.||micrograms||Standard Deviation|Geometric Mean
670524|NCT01699698|Secondary|The Sensitivity and Specificity to Detect UICC Stage II Pancreatic Ductal Adenocarcinoma Among All Participants.|Based on each analyzing result of pancreatic cancer markers and corresponding final diagnosis, a receiver operating characteristic (ROC) is evaluated. A cut-off is then chosen from this ROC curve to maximize both sensitivity and specificity.<Method>1. create an ROC curve using the measured concentrations, 2. set a threshold, 3. report how many patients in each group would are exceeded the threshold. (The rate of exceeded threshold in Test subject group is sensitivity, The rate of 1-(the rate of exceeded threshold in Control group) is specificity.)|1 year|||participants|||Number
670525|NCT01699698|Primary|The Concentration of the Pancreatic Cancer Markers of the Normal Cohort and UICC Stage II Pancreatic Ductal Adenocarcinoma Cohort|"We hypothesized that there is a statistically-significant difference between two cohorts.
The cancer marker is S100P."|1year|||pg/ml||Full Range|Median
670526|NCT01699685|Secondary|Airway Resistance (Raw)|Raw was measured with spirometry conducted according to internationally accepted standards. Raw was the mean of the measurements which were measured each at 30, 60, 120, 180 and 240 minutes|Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours|Full analysis set (FAS) included all randomized patients who received at least one dose of study medication during at least one study period. Participants with observations after 4 hours were included in the analysis||cmH2O/l/s||Standard Deviation|Mean
670527|NCT01699685|Secondary|Total Lung Capacity (TLC)|TLC was measured with spirometry conducted according to internationally accepted standards. Peak TLC was calculated as the mean of the three Functional Residual Capacity peak measurements plus the mean of the three Inspiratory Capacity measurements which were measured each at 30, 60, 120, 180 and 240 minutes post dose|Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours|Full analysis set (FAS) included all randomized patients who received at least one dose of study medication during at least one study period. Participants with observations after 4 hours were included in the analysis||Liters||Standard Deviation|Mean
670528|NCT01699685|Secondary|Forced Volume Capacity (FVC)|FVC was measured with spirometry conducted according to internationally accepted standards. Measurements were made 30, 60, 120, 180, and 240 minutes post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time|Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours|Full analysis set (FAS) included all randomized patients who received at least one dose of study medication during at least one study period. Participants with observations after 4 hours were included in the analysis||Liters||Standard Deviation|Mean
670529|NCT01699685|Secondary|Inspiratory Capacity (IC)|During the 4 hours following inhalation of the study treatment, inspiratory capacity (IC) was measured with spirometry conducted according to internationally accepted standards. IC was measured at 30, 60, 120, 180, and 240 minutes post-dose|within 4h after dosing|Full analysis set (FAS) included all randomized patients who received at least one dose of study medication during at least one study period. Participants with observations after 4 hours were included in the analysis||Liters||Standard Deviation|Mean
670530|NCT01699685|Secondary|Forced Expiratory Volume in One Second (FEV1)|FEV1 was measured with spirometry conducted according to internationally accepted standards. FEV1 was at 30, 60, 120, 180, and 240 minutes post-dose. Spirometry equipment and performance of spirometric testing had to be in accordance with standards as outlined in the American Thoracic Society for the Standardization of Spirometry recommendations. The spirometry equipment used during the study had to meet or exceed these minimal ATS recommendations|Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours|Full analysis set (FAS) included all randomized patients who received at least one dose of study medication during at least one study period. Participants with observations after 4 hours were included in the analysis||Liters||Standard Deviation|Mean
670531|NCT01699685|Primary|Inspiratory Capacity (IC) Peak Value|IC was measured with spirometry conducted according to internationally accepted standards. Peak IC was defined as the maximum IC of the mean at one of the post-dose measurements (30min, 60min, 120min, 180min and 240min).|Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours|Full analysis set (FAS) included all randomized patients who received at least one dose of study medication during at least one study period. Participants with observations after 4 hours were included in the analysis.||Liters||Standard Deviation|Mean
670532|NCT01699607|Primary|Change in Dopamine Levels at Baseline and After Amphetamine Administration as Measured by Percent Change in PET Tracer Binding Potential.|PET images will be obtained in subjects at baseline and after amphetamine administration. Dopamine release will be measured as a percent change in binding potential. Increased dopamine release will result in decreased radiotracer binding because dopamine will displace the radiotracer.|first 90 minute scan at baseline, second 90 minute scan start 150 minutes post amphetamine administration|||percent change in binding potential||Standard Deviation|Mean
670535|NCT01699087|Primary|Percentage of Eyes With > 2.0 D of Induced Manifest Refractive Cylinder Magnitude, as Compared to Baseline, at Refractive Stability|Manifest refraction was performed monocularly under photopic lighting conditions using an ETDRS chart at 4 meters. The subject was manually refracted to his/her best correction using a phoropter. The cylinder value is from the manifest refraction assessment. The induced manifest refractive cylinder is the change in magnitude of cylinder compared to baseline.|Month 6 (post second eye surgery)|ITT||percentage of eyes|eyes||Number
670536|NCT01699087|Primary|Percentage of Eyes With a BSCVA Worse Than 20/40 (for Eyes With BSCVA of 20/20 or Better Preoperatively) at Refractive Stability|Visual acuity with correction was assessed monocularly using the ETDRS chart at 4 meters under photopic conditions .|Month 6 (post second eye surgery)|ITT||percentage of eyes|eyes||Number
670537|NCT01699087|Primary|Percentage of Eyes With BSCVA Decrease of ≥ 2 Lines From Baseline at Refractive Stability|Visual acuity with correction was assessed monocularly using the ETDRS chart at 4 meters under photopic conditions . A decrease in 2 lines or more is considered clinically relevant (i.e. worse).|Month 6 (post second eye surgery)|ITT||percentage of eyes|eyes||Number
670538|NCT01699087|Primary|Cumulative Incidence of Ocular Serious Adverse Events by Eye|Participants were followed for the duration of the study, an expected average of 24 months.|Up to Month 24 (post second eye surgery)|ITT||eyes|eyes||Number
670539|NCT01699087|Primary|Percentage of Eyes That Have a Change of ≤ 1.0 D in MRSE and Manifest Refractive Cylinder Between Consecutive Scheduled Visits|MRSE is calculated as sphere + 1/2 cylinder. The sphere and cylinder values are from the manifest refraction assessment. The manifest refraction assessment was conducted monocularly with the ETDRS chart at 4 meters under photopic conditions using a phoropter.|Up to Month 24 (post second eye surgery)|ITT||percentage of eyes|eyes||Number
670540|NCT01699087|Primary|Percentage of Eyes Achieving Manifest Refractive Cylinder Within ± 0.5 D of Zero at Refractive Stability|Manifest refraction was performed monocularly under photopic lighting conditions using an ETDRS chart at 4 meters. The subject was manually refracted to his/her best correction using a phoropter.|Month 6 (post second eye surgery)|ITT||percentage of eyes|eyes||Number
670541|NCT01699087|Primary|Percentage of Eyes Achieving Manifest Refractive Cylinder Within ± 1.0 D of Zero at Refractive Stability|Manifest refraction was performed monocularly under photopic lighting conditions using an ETDRS chart at 4 meters. The subject was manually refracted to his/her best correction using a phoropter.|Month 6 (post second eye surgery)|ITT||percentage of eyes|eyes||Number
670542|NCT01699087|Primary|Percentage of Eyes Achieving MRSE Within ± 0.5 D of Zero at Refractive Stability|Manifest refraction spherical equivalent (MRSE) is calculated as follows: sphere + 1/2 cylinder. The sphere and cylinder values are from the manifest refraction assessment. The manifest refraction assessment was conducted monocularly with the ETDRS chart at 4 meters under photopic conditions using a phoropter.|Month 6 (post second eye surgery)|ITT||percentage of eyes|eyes||Number
670543|NCT01699087|Primary|Percentage of Eyes Achieving Manifest Refraction Spherical Equivalent (MRSE) Within ± 1.0 D of Zero at Refractive Stability|Manifest refraction spherical equivalent (MRSE) is calculated as follows: sphere + 1/2 cylinder. The sphere and cylinder values are from the manifest refraction assessment. The manifest refraction assessment was conducted monocularly with the ETDRS chart at 4 meters under photopic conditions using a phoropter.|Month 6 (post second eye surgery)|ITT||percentage of eyes|eyes||Number
670544|NCT01699087|Primary|Percentage of Eyes Achieving Uncorrected Visual Acuity (UCVA) of 20/40 or Better at Refractive Stability in Eyes With Best Spectacle-corrected Visual Acuity (BSCVA) of 20/20 or Better Preoperatively|Visual acuity, with and without correction, was assessed monocularly using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at 4 meters under photopic conditions . The with-correction assessment was made with the manifest refraction at 4 meters.|Month 6 (post second eye surgery)|Intent to treat (ITT)||percentage of eyes|eyes||Number
670545|NCT01699022|Primary|Serum Progesterone Concentration|"Return of ovulation measured by changes in serum progesterone concentration by
analysis on Day 18, Day 21 (Control cycle), Day 103, Day 106, Day 131 and Day 134 indicating the number of subjects who achieved ovulation"|Day 134|||participants|||Number
670546|NCT01699022|Primary|T1/2|Mean no of days for MPA and E2|"Day 85"|Tmax||day||Standard Deviation|Mean
670547|NCT01699022|Primary|Tmax|Mean serum concentrations of E2 peaked by 3.3 days (range 1 – 7 days) following the third monthly injection|"Day 85"|Tmax||day||Standard Deviation|Mean
670548|NCT01699022|Primary|E2 Pharmacokinetics|AUC 0-28, AUC(0-inf)|Day 28|||pg.day/mL||Standard Deviation|Mean
670549|NCT01699022|Primary|E2 Concentrations|Mean serum E2 concentrations on Day 1, Day 29, Day 57 and Day 85|"Day 1, Day 29, Day 57' and ''Day 85"|||pg/mL||Standard Deviation|Mean
670550|NCT01699022|Primary|MPA Pharmacokinetics T1/2||"Day 85"|||day||Standard Deviation|Mean
670551|NCT01699022|Primary|MPA Pharmacokinetics Tmax|Mean serum MPA concentrations peaked at 4.1 days (range 1 – 21 days) after the third monthly administration of Cyclofem.|"Day 85"|||day||Standard Deviation|Mean
670552|NCT01699022|Primary|MPA Pharmacokinetics Cmax|The mean serum concentration-time profile for MPA after three consecutive monthly intramuscular administration of Cyclofem|85 days|||ng/mL||Standard Error|Mean
670553|NCT01699022|Primary|MPA Pharmacokinetics|The mean serum concentration-time profile for MPA after three consecutive monthly intramuscular administration of Cyclofem (AUC)|"Day 85"|||ng.day/mL||Standard Error|Mean
670554|NCT01699022|Primary|MPA Concentrations|Assessment of mean trough levels of MPA on Day 1, Day 29, Day 57 and Day 85|"Day 1, Day 29, Day 57' and 'Day 85"|||ng/mL||Standard Deviation|Mean
670555|NCT01698814|Primary|Adverse Events|An adverse event was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and as observations by the study Investigator.|An average of 6 weeks|This reporting group includes all randomized subjects who received study medication.||participants|||Number
670573|NCT01698710|Secondary|Feasibility of Endoscopic Ultrasonography (EUS) Guided Injection of Albumin-bound Paclitaxel Into Pancreatic Cysts|The feasibility of the procedure will be measured by the ease of injection of albumin-bound paclitaxel into the cyst cavity across the gastro-duodenal wall. On a subjective scale, the endoscopist will note the ease of the procedure on a scale of 0-5, with 5 being very easy and 0 is not possible. Any score less than 2 will be considered unacceptable and failure of the study.|immediately after procedure|||units on a scale||Full Range|Median
670556|NCT01698801|Secondary|Number of Participants With Adverse Events|An adverse event is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. A serious AE is any AE occurring at any dose that: • Results in death; • Is life-threatening; • Requires or prolongs existing inpatient hospitalization; • Results in persistent or significant disability/incapacity; • Is a congenital anomaly/birth defect; • Constitutes an important medical event. The Investigator assessed the relationship of each AE to study drug and graded the severity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0): Grade 1 = Mild (no limitation in activity or intervention required); Grade 2 = Moderate (some limitation in activity; no/minimal medical intervention required);-Grade 3 = Severe (marked limitation in activity; medical intervention required, hospitalization possible); Grade 4 = Life-threatening; Grade 5 = Death.|From first dose of study drug treatment through to 28 days after the last dose, until the data cut-off date of 15 July 2014; median treatment duration was 60 weeks|Safety population includes all participants who received at least one dose of study drug.||participants|||Number
670557|NCT01698801|Secondary|Overall Survival (OS)|The time from the start of study treatment to death due to any cause. OS was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented.|From the first dose of study drug treatment until the data cut-off date of 15 July 2014. Median follow up is 14.2 months|Efficacy Evaluable (EE) Population consists of all participants who met the protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of study drug.||months||95% Confidence Interval|Median
670558|NCT01698801|Secondary|Progression Free Survival (PFS)|PFS was calculated as the time from the first dose date to the first documented progression based on IWG criteria or death due to any cause, whichever occurred first. If progression or death was not documented at the time of data cutoff date, these observations were censored at the last adequate assessment date showing evidence of no progression or death.|From the first dose of study drug treatment until the data cut-off date of 15 July 2014. Median follow-up for PFS assessments was 61.6 weeks.|Efficacy Evaluable (EE) Population consists of all participants who met the protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of study drug.||months||95% Confidence Interval|Median
670559|NCT01698801|Secondary|Duration of Response|Duration of response was calculated for the responders as the time from the initial documented response (CR or VGPR or PR) to the first documented progression or death due to any cause, whichever occurred first. Duration of response for participants last known to be alive with no progression after a CR, VGPR, or PR were censored at the date of last adequate response assessment.|From the first dose of study drug treatment until the data cut-off date of 15 July2014. Median follow up time was 61.6 weeks.|Efficacy Evaluable (EE) Population consists of all participants who meet protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of study drug||months||95% Confidence Interval|Median
670560|NCT01698801|Secondary|Time to Response|"Time to response was calculated for the responders as the time from the first dose date to the initial documented response (CR, VGPR or PR).
CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. If present at baseline a ≥ 50% reduction in size of soft tissue plasmacytomas is also required."|From the first dose of study drug treatment until the data cut-off date of 15 July 2014. Median follow-up time was 61.6 weeks.|Efficacy Evaluable (EE) Population consists of all participants who meet protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of study drug||months||Full Range|Median
670561|NCT01698801|Primary|Overall Response Rate|"Number of Complete Responses (CR) plus Very Good Partial Response (VGPR) plus Partial Response (PR) based on the International Myeloma Working Group criteria (IMWG). Any participant who achieved a CR, VGPR, or PR while on study treatment was defined as a responder.
CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. In addition to the above, if present at baseline a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required."|From first dose until the data cut-off date of 15 July 2014. Median time on follow-up was 61.6 weeks.|Efficacy Evaluable (EE) Population consists of all participants who met the protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of study drug.||percentage of participants|||Number
670562|NCT01698775|Secondary|Change From Baseline in eGFR at Week 54|Based on an cLDA model including terms for treatment, renal status stratum, treatment on insulin at screening stratum, time, the interaction of time by treatment, the interaction of time by renal status stratum, and the interaction of time by treatment on insulin at screening stratum, with the constraint that the mean baseline is the same for all treatment groups. Excluding data after glycemic rescue or initiation of dialysis as well as participants classified with ESRD on dialysis.|Baseline and Week 54|APaT population consists of all randomized participants who took at least 1 dose of trial treatment. Excludes all participants on dialysis and data after initiation of dialysis. Phase B includes 1 omarigliptin participant in the severe renal impairment stratum (not on dialysis) who was misclassified in the ESRD stratum on dialysis during Phase A.||mL/min/1.73 m^2||95% Confidence Interval|Least Squares Mean
670574|NCT01698710|Primary|Frequency of Pancreatitis|Safety of injection of albumin-bound paclitaxel will be measured by the frequency of pancreatitis.|3-10 months (median 6 months) after injection therapy|||Participants|||Count of Participants
670575|NCT01698684|Primary|Per-subject Proportion of Sexual Attempts That Had an Erectogenic Effect Within Approximately 15 Minutes Following Dosing||Week 0 (Baseline) up to Week 8 (End of Study)|The intent-to-treat (ITT) population consists of all subjects who are randomized, take at least 1 dose of study medication, and have at least 1 post-dose efficacy assessment.||percentage of successes||Standard Deviation|Mean
670840|NCT01694420|Primary|Virologic Efficacy of the Fixed Dose Combination (FDC) ELV/COBI/FTC/TDF Given Once Daily to Participants With Acute HIV Infection as Determined by the Proportion of Treated Participants With HIV-1 RNA to <50 Copies/mL at Week 48||48 weeks|||participants|||Number
670563|NCT01698775|Secondary|Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 24|Based on an cLDA model including terms for treatment, renal status stratum, treatment on insulin at screening stratum, time, the interaction of time by treatment, the interaction of time by renal status stratum, and the interaction of time by treatment on insulin at screening stratum, with the constraint that the mean baseline is the same for all treatment groups. Excluding data after glycemic rescue or initiation of dialysis as well as participants classified with end stage renal disease (ESRD) on dialysis.|Baseline and Week 24|APaT population consists of all randomized participants who took at least 1 dose of trial treatment. Excludes participants on dialysis and data after initiation of dialysis. One omarigliptin participant with severe renal impairment was misclassified as ESRD on dialysis in Phase A and was excluded from the Phase A analysis (corrected in Phase B).||mL/min/1.73 m^2||95% Confidence Interval|Least Squares Mean
670564|NCT01698775|Secondary|Change From Baseline in FPG at Week 54|Change from baseline in FPG at Week 54 was analyzed using cLDA method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, renal insufficiency stratum, baseline treatment with insulin stratum, time, the interaction of time by treatment, the interaction of time by renal insufficiency stratum, and the interaction of time by baseline treatment with insulin stratum.|Baseline and Week 54|FAS population included all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a post-randomization measurement for the analysis endpoint subsequent to at least 1 dose of study medication.||mg/dL||95% Confidence Interval|Least Squares Mean
670565|NCT01698775|Secondary|Change From Baseline in A1C at Week 54|A1C is measured as a percent. Change from baseline in A1C at Week 54 was analyzed using cLDA method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, renal insufficiency stratum, baseline treatment with insulin stratum, time, the interaction of time by treatment, the interaction of time by renal insufficiency stratum, and the interaction of time by baseline treatment with insulin stratum.|Baseline and Week 54|FAS population included all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a post-randomization measurement for the analysis endpoint subsequent to at least 1 dose of study medication.||Percent||95% Confidence Interval|Least Squares Mean
670566|NCT01698775|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Change from baseline in FPG at Week 24 was analyzed using cLDA method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, renal insufficiency stratum, baseline treatment with insulin stratum, time, the interaction of time by treatment, the interaction of time by renal insufficiency stratum, and the interaction of time by baseline treatment with insulin stratum.|Baseline and Week 24|FAS population included all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a post-randomization measurement in Phase A for the analysis endpoint subsequent to at least 1 dose of study medication.||mg/dL||95% Confidence Interval|Least Squares Mean
670567|NCT01698775|Primary|Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (Phase A: 24-week Placebo Controlled Period + Phase B: 30-week Active Controlled Period)|An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Presented data exclude data after glycemic rescue.|Up to 54 weeks|APaT population consists of all randomized participants who took at least 1 dose of trial treatment.||Percentage of participants|||Number
670568|NCT01698775|Primary|Percentage of Participants Who Experienced at Least One Adverse Event (Phase A: 24-week Placebo Controlled Period + Phase B: 30-week Active Controlled Period)|An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Presented data exclude data after glycemic rescue.|Up to 58 weeks (including 28 days following the last dose of study therapy)|APaT population consists of all randomized participants who took at least 1 dose of trial treatment.||Percentage of participants|||Number
670569|NCT01698775|Primary|Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (Phase A: 24-week Placebo Controlled Period)|An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Presented data exclude data after glycemic rescue.|Up to 24 weeks|APaT population consists of all randomized participants who took at least 1 dose of trial treatment.||Percentage of participants|||Number
670570|NCT01698775|Primary|Percentage of Participants Who Experienced at Least One Adverse Event (Phase A: 24-week Placebo Controlled Period)|An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Presented data exclude data after glycemic rescue.|Up to 28 weeks (including 28 days following the last dose of study therapy for participants who discontinued study drug)|All-Participants-as-Treated (APaT) population consists of all randomized participants who took at least 1 dose of trial treatment.||Percentage of participants|||Number
670571|NCT01698775|Primary|Change From Baseline in Glycosylated Hemoglobin (A1C) at Week 24|A1C is measured as a percent. Change from baseline in A1C at Week 24 was analyzed using constrained longitudinal data analysis (cLDA) method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, renal insufficiency stratum, baseline treatment with insulin stratum, time, the interaction of time by treatment, the interaction of time by renal insufficiency stratum, and the interaction of time by baseline treatment with insulin stratum.|Baseline and Week 24|Full analysis set (FAS) population included all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a post-randomization measurement in Phase A for the analysis endpoint subsequent to at least 1 dose of study medication.||Percent||95% Confidence Interval|Least Squares Mean
670572|NCT01698710|Secondary|Size of Cystic Lesion|Determine the size of the cystic lesion using CT scanning. Number of participants with reduction in size, persistent size, or increase in size of cyst are reported.|3-10 months (median 6 months) after injection therapy|||Participants|||Count of Participants
670633|NCT01697462|Secondary|Percentage of Participants With Disease Progression|Disease progression was defined as greater than 20 percent (%) increase in sum of longest diameter of target lesions compared to baseline.|Baseline to progressive disease or death (up to 42 months)|ITT population. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome.||Percentage of participants|||Number
670576|NCT01698554|Secondary|Percentage of Participants Satisfied or Very Satisfied in the Patient's Assessment of Overall Eyelash Satisfaction as Measured by the Eyelash Satisfaction Questionnaire (ESQ-9)|"Participants rated their overall eyelash satisfaction by answering Eyelash Satisfaction Questionnaire (ESQ-9) question #3: Overall, how satisfied are you with your eyelashes? using a 5-point scale: 1= very unsatisfied (worst), 2= unsatisfied, 3= neutral, 4= satisfied or 5= very satisfied (best). The percentage of participants who rated their satisfaction as satisfied or very satisfied at Month 4 is reported."|Month 4|ITT Population included all randomized participants.||percentage of participants|||Number
670577|NCT01698554|Secondary|Change From Baseline in Upper Eyelash Intensity (Darkness) as Measured Using DIA|Photographs were taken of the eyelashes and assessed using DIA. Eyelash darkness (intensity) was measured in both eyes and averaged for analysis using a scale where 0=black and 255=white. A negative change from Baseline indicated darker eyelashes (improvement).|Baseline, Month 4|Participants from the ITT Population, all randomized participants, with data available for analysis.||intensity units||Standard Deviation|Mean
670578|NCT01698554|Secondary|Change From Baseline in Upper Eyelash Thickness/Fullness as Measured Using DIA|Photographs were taken of the eyelashes and assessed using DIA. Eyelash thickness (fullness) was measured in millimeters squared (mm^2). Data from both eyes were averaged for each participant for analysis. A positive change from Baseline indicated fuller eyelashes (improvement).|Baseline Month 4|Participants from the ITT Population, all randomized participants, with data available for analysis.||mm^2||Standard Deviation|Mean
670579|NCT01698554|Secondary|Change From Baseline in Upper Eyelash Length as Measured Using Digital Image Analysis (DIA)|Photographs were taken of the eyelashes and assessed using DIA. Length was measured in millimeters (mm). Data from both eyes were averaged for each participant for analysis. A positive change from Baseline indicated longer length (improvement)|Baseline, Month 4|Participants from the ITT Population, all randomized participants, with data available for analysis.||mm||Standard Deviation|Mean
670580|NCT01698554|Primary|Percentage of Participants With at Least a 1-Grade Increase (Improvement) From Baseline in the Investigator's Assessment of Overall Eyelash Prominence (GEA)|The investigator evaluated the overall eyelash prominence in both eyes using the GEA 4-point scale: 1= minimal, 2= moderate, 3= marked and 4= very marked. A 1-grade improvement in the GEA score from Baseline indicated improvement.|Baseline, Month 4|Intent-to-treat (ITT) Population included all randomized participants.||percentage of participants|||Number
670581|NCT01698528|Secondary|Time Health Care Providers and Subjects Spend on Managing the Insulin Titration|time health care providers and subjects spend on managing the insulin titration through appointment, phone call, emails, faxes|3 months|||min||Standard Deviation|Mean
670582|NCT01698528|Secondary|Number of Participants With Hypoglycemia|Number of participants had hypoglycemia during the trial period|3 months|||Participants|||Count of Participants
670583|NCT01698528|Secondary|Change in Average Participation Satisfaction|The volunteer's satisfaction with their diabetes care will be measured at the beginning and at the end of the study. Diabetes Treatment Satisfaction Questionnaire (DTSQ) was used for assessing the satisfactory level. DTSQ consisted of 8 questions, each question with a score scale of 0-6 (very dissatisfied to very satisfied), leading to a final score range of 0-48. The change in the DTSQ comparing before (time 0) and end of the study (t=3months) was measured. The average change in the intervention group and control group were listed in the outcome measure data table.|3 months|||points||Standard Deviation|Mean
670584|NCT01698528|Secondary|Number of Participants Reaching Target of HbA1c ≤ 7%|Secondary outcomes will include % of participants reaching glycemic target of A1c≤7.|3 months|||Participants|||Count of Participants
670585|NCT01698528|Primary|Glycemic Control as Determined by the Change in Absolute HbA1c Level|The primary outcome of interest is absolute decrease in A1c by end of 3 months.|3 months|||Percent A1C||Standard Deviation|Mean
670586|NCT01698502|Secondary|The Total Glucose-dependent Insulinotropic Peptide (GIP) Response Measured as Area Under the GIP Curve (AUC GIP).|Comparison of the total release of GIP during the 3 hour OGTT and IIGI.|Test day 1 and 2 within 7 days.|||pmol/L * 210 min||Standard Error|Mean
670587|NCT01698502|Primary|Incretin Effect (the % of Insulin Secreted Due to the Release of the Intestinal Hormones Glucagon Like Peptide-1 (GLP-1 and Glucose-dependent Insulinotropic Peptide (GIP))|The Incretin effect (the % of insulin secreted due to the release of the intestinal hormones GLP-1 and GIP) is calculated as the difference between the insulin concentration during a 3 hour oral glucose tolerance test (OGTT) (day 1) compared to a 3 hour isoglycemic intravenous glucose infusion (IIGI) (day 2) that has similar glucose excursions.|Test day 1 and 2 within 7 days.|||percentage||Standard Error|Mean
670588|NCT01698320|Primary|Participants With Abnormal and Clinically Relevant Physical Exam Findings at Weeks 0, 12 and 52|"The physical exam was performed by a qualified healthcare professional, and when possible, the same qualified healthcare professional that performed the physical examination at study screening performed all the scheduled physical examinations. Abnormalities and clinical relevance were determined by the qualified healthcare professional.
HEENT = head, eyes, ears, nose, throat"|Weeks 0, 12 and 52|Safety population. Participants with assessments at each time point are reported.||participants|||Number
670589|NCT01698320|Primary|Change From Baseline in Pulse Measurements to Week 12 and Week 52|"Participants were seated at least 2 minutes before pulse measurements were obtained by radial pulse.
Week 12 values represent change from Week 0. Week 52 values represent change from Week 12."|Week 0, Week 12 and Week 52|Safety population. Participants with assessments at each time point are reported.||beats/minute||Standard Deviation|Mean
670590|NCT01698320|Primary|Change From Baseline in Blood Pressure Measurements to Week 12 and Week 52|"Participants were seated at least 2 minutes before blood pressure measurements were obtained by either an electronic or manual sphygmomanometer.
Week 12 values represent change from Week 0. Week 52 values represent change from Week 12."|Week 0, Week 12 and Week 52|Safety population. Participants with assessments at each time point are reported.||mmHg||Standard Deviation|Mean
670591|NCT01698320|Primary|Electrocardiogram (ECG) Results At Weeks 0, 12, and 52|A standard 12-lead ECG was performed at screening, week 12, and week 52 or early termination/discontinuation. The ECG recording methods were centralized and standardized across all study participants. A centralized cardiologist was responsible for providing all ECG interpretations.|Weeks 0 (screening visit), 12, and 52|Safety population. Participants with assessments at each time point are reported.||participants|||Number
670841|NCT01694420|Primary|Number of Participants With a Viral Load Measurement of <200 Copies/mL at Week 24||24 weeks|||participants|||Number
670592|NCT01698320|Primary|Participants With Adverse Experiences During Weeks 13-52 (Open-Label Period)|Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Weeks 13-52|Safety population||participants|||Number
670593|NCT01698320|Other Pre-specified|Daily AM Peak Expiratory Flow (PEF) to Week 52|Daily AM PEF will be recorded throughout the duration of the study to provide information on the subject's asthma status in order to assist in distinguishing between the use of back-up rescue medication related to an increased need for asthma symptom relief from that related to an issue with the Albuterol Spiromax® rescue inhaler.|Baseline to Week 52||||||
670594|NCT01698320|Other Pre-specified|Device Invitro Evaluations to Week 52|"Device In Vitro Evaluations - All used study inhalers will be collected and a random selection of inhalers will be tested as follows:
Fifty (50) Albuterol Spiromax® inhalers used during weeks 0-12 will be randomly selected for in vitro testing
Fifty (50) Albuterol Spiromax® inhalers used during weeks 12-52 will be randomly selected for in vitro performance testing"|Baseline to Week 52||||||
670595|NCT01698320|Other Pre-specified|Composite Measurement of Device Ruggedness From Baseline to Week 52|Device Ruggedness: Reports of any problems/malfunction of the device (e.g., lack of efficacy, problems/malfunction after the device is dropped or sustains physical impact).|Baseline to Week 52||||||
670596|NCT01698320|Primary|Participants With Adverse Experiences During Weeks 0-12 (Double-Blind Period)|Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 to Week 12|Safety population||participants|||Number
670597|NCT01698268|Primary|FLACC: Face, Legs, Activity, Cry, and Consolability Pain Assessment Scale (FLACC)|FLACC: Face, Legs, Activity, Cry, and Consolability Pain Assessment Scale (FLACC), a five-item, three point scale that measures pain behavior on a scale of 0 - 2 which are summed to result in a total score of 0 - 10. Clinical judgment is used to interpret pain. The higher the score on the FLACC correlates with a higher pain score (0= no behaviors indicative of pain and 10= five behaviors indicative of significant pain). This scale was evaluated by blinded post-operative anesthesia care unit (PACU) Registered Nurses (RNs) at admission to PACU.|Admission into PACU|||units on a scale||Inter-Quartile Range|Median
670598|NCT01697969|Primary|Patient-Assessed Ocular Itching|The patient rated the severity of ocular itching using a predetermined 0-4 scale, where 0=none and 4=severe itching with irresistible urge to rub. Each eye was rated separately. A 2-week washout period from prior allergy medication (if applicable) preceded the baseline assessment.|Baseline (Day 1), Day 14|The analysis population includes all participants exposed to the test product. Here, “n” is the number of participants with non-missing values at the specific time point.||units on a scale||Standard Deviation|Mean
670599|NCT01697956|Secondary|Participants With Shifts in Serum Chemistry Results From Normal at Screening to High or Low at End of Study|"Shifting to 'High' refers to starting the study within normal range and being outside the high-end of normal by end of study. Conversely, shifting to 'Low' refers to starting the study within normal range and being outside the low-end of normal by end of study.
BUN = blood urea nitrogen AST = aspartate transaminase ALT = alanine transaminase GGT = gamma-glutamyl transpeptidase"|Screening (Day -21 to -7), End of Study (Day 42)|Safety population||participants|||Number
670600|NCT01697956|Secondary|Participants With Shifts in Hematology Results From Normal at Screening to High or Low at End of Study|"Shifting to 'High' refers to starting the study within normal range and being outside the high-end of normal by end of study. Conversely, shifting to 'Low' refers to starting the study within normal range and being outside the low-end of normal by end of study.
MCHC = mean corpuscular hemoglobin concentration MCV = mean corpuscular volume, or mean cell volume MCH = mean corpuscular hemoglobin or mean cell hemoglobin"|Screening (Day -21 to -7), End of Study (Day 42)|Safety population||participants|||Number
670601|NCT01697956|Secondary|Participants With Treatment-Emergent Adverse Events (AEs)|"The intensity or severity of the AE was characterized as mild (AE which is easily tolerated), moderate (AE sufficiently discomforting to interfere with daily activity) or severe (AE which prevents normal daily activities).
The causal relationship was characterized as not related (no reasonable possibility that the AE was caused by or attributed to the investigational product) or related reasonable possibility that the AE was caused by or attributed to the investigational product / a causal relationship cannot be ruled out).
An SAE was defined as an AE that resulted in any of the following:
Death
Life-threatening
Required hospitalization or prolonged existing hospitalization
Persistent or significant disability or incapacity
A congenital abnormality or birth defect
An important medical event which required medical intervention to prevent any of the above outcomes."|Day 1- week 10|Safety population which included all randomized participants who received at least one dose of randomized study medication.||participants|||Number
670654|NCT01697319|Primary|Percent Change From Baseline in Speed as Measured in Timed 25-Foot Walk Test (25FWT)|The timed 25-Foot Walk Test (25FWT) is an assessment of mobility and performance of leg function. The patient was instructed to walk a marked 25-foot course as quickly as possible in a time limit of 3 minutes and immediately walk back the same distance when reaching one end.The patient is allowed to use any ambulation method to move. The outcome measures the speed (feet / min) of moving.|Up to 96 weeks|Modified ITT Population||% of change||Standard Deviation|Mean
670602|NCT01697956|Secondary|Terminal Elimination Half-life (t1/2) for Beclomethasone-17-monopropionate (17-BMP)|Beclomethasone-17-monopropionate (17-BMP) is the active metabolite of BDP. Plasma concentrations of 17-BMP or BDP that were below the lower-limit-of-quantitation (LLOQ), 20 or 10 pg/mL, respectively, were assigned a zero value when calculating descriptive statistics.|Day 42 (Predose (within 30 minutes prior to dose administration) and at 0.25 (15 min), 0.5 (30 min), 1, 1.5, 3, 6, 12, and 24 hours after final study medication administration)|Per protocol population of participants administered BDP nasal aerosol 80 mcg/day. Due to the short duration of measurable BDP concentrations in plasma, t1/2 for BDP could not be estimated for any participants.||hours||Standard Deviation|Mean
670603|NCT01697956|Secondary|Terminal Elimination Rate Constant (λz ) for Beclomethasone-17-monopropionate (17-BMP)|Beclomethasone-17-monopropionate (17-BMP) is the active metabolite of BDP. Plasma concentrations of 17-BMP or BDP that were below the lower-limit-of-quantitation (LLOQ), 20 or 10 pg/mL, respectively, were assigned a zero value when calculating descriptive statistics.|Day 42 (Predose (within 30 minutes prior to dose administration) and at 0.25 (15 min), 0.5 (30 min), 1, 1.5, 3, 6, 12, and 24 hours after final study medication administration)|Per protocol population of participants administered BDP nasal aerosol 80 mcg/day. Due to the short duration of measurable BDP concentrations in plasma, λz for BDP could not be estimated for any participants.||1/hour||Standard Deviation|Mean
670604|NCT01697956|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) for Beclomethasone-17-monopropionate (17-BMP) and Beclomethasone Dipropionate (BDP)|Beclomethasone-17-monopropionate (17-BMP) is the active metabolite of BDP. Plasma concentrations of 17-BMP or BDP that were below the lower-limit-of-quantitation (LLOQ), 20 or 10 pg/mL, respectively, were assigned a zero value when calculating descriptive statistics.|Day 42 (Predose (within 30 minutes prior to dose administration) and at 0.25 (15 min), 0.5 (30 min), 1, 1.5, 3, 6, 12, and 24 hours after final study medication administration)|Per protocol population of participants administered BDP nasal aerosol 80 mcg/day. Plasma BDP concentrations were generally low and were only measurable over a short period of time.||hours||Standard Deviation|Mean
670605|NCT01697956|Secondary|Maximum Plasma Concentration (Cmax) for Beclomethasone-17-monopropionate (17-BMP) and Beclomethasone Dipropionate (BDP)|Beclomethasone-17-monopropionate (17-BMP) is the active metabolite of BDP. Plasma concentrations of 17-BMP or BDP that were below the lower-limit-of-quantitation (LLOQ), 20 or 10 pg/mL, respectively, were assigned a zero value when calculating descriptive statistics.|Day 42 (Predose (within 30 minutes prior to dose administration) and at 0.25 (15 min), 0.5 (30 min), 1, 1.5, 3, 6, 12, and 24 hours after final study medication administration)|Per protocol population of participants administered BDP nasal aerosol 80 mcg/day.||pg/mL||Standard Deviation|Mean
670606|NCT01697956|Secondary|Area Under the Concentration-time Curve From Time Zero to 24 Hours (AUC0-24) for Beclomethasone-17-monopropionate (17-BMP) and Beclomethasone Dipropionate (BDP)|Beclomethasone-17-monopropionate (17-BMP) is the active metabolite of BDP. Plasma concentrations of 17-BMP or BDP that were below the lower-limit-of-quantitation (LLOQ), 20 or 10 pg/mL, respectively, were assigned a zero value when calculating descriptive statistics.|Day 42 (Predose (within 30 minutes prior to dose administration) and at 0.25 (15 min), 0.5 (30 min), 1, 1.5, 3, 6, 12, and 24 hours after final study medication administration)|Per protocol population of participants administered BDP nasal aerosol 80 mcg/day. Plasma BDP concentrations were generally low and were only measurable over a short period of time.||h*pg/mL||Standard Deviation|Mean
670607|NCT01697956|Secondary|Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration (AUC0-t ) for Beclomethasone-17-monopropionate (17-BMP) and Beclomethasone Dipropionate (BDP)|Beclomethasone-17-monopropionate (17-BMP) is the active metabolite of BDP. Plasma concentrations of 17-BMP or BDP that were below the lower-limit-of-quantitation (LLOQ), 20 or 10 pg/mL, respectively, were assigned a zero value when calculating descriptive statistics.|Day 42 (Predose (within 30 minutes prior to dose administration) and at 0.25 (15 min), 0.5 (30 min), 1, 1.5, 3, 6, 12, and 24 hours after final study medication administration)|Per protocol population of participants administered BDP nasal aerosol 80 mcg/day||h*pg/mL||Standard Deviation|Mean
670608|NCT01697956|Primary|Change From Baseline (Expressed As A Ratio) In 24-Hr Serum Cortisol Weighted Mean Following 6 Weeks Of Treatment|The serum cortisol weighted mean (0-t), calculated by dividing the area under the concentration-time curve (AUC) from time zero to the time of the last measurable value over the 24-hour period by the sample collection time interval, was determined for each participant at baseline and Week 6, and the ratio of Week 6 over baseline was derived.|Baseline (Day 1, -24, -22, -20, -16, -12, -8, and 0 hours prior to study medication), End of Treatment (Day 43, (Immediately prior to study medication administration (Hour 0) and at 2, 4, 8, 12, 16, and 24 hours after study medication administration)|Per protocol (PP) population||ratio||Standard Error|Geometric Mean
670609|NCT01697696|Secondary|Time to First COPD Exacerbation (Moderate or Severe).|COPD exacerbations are considered to be moderate if treatment with systemic corticosteroids and/or antibiotics was required. COPD exacerbations are considered to be severe if hospitalizations were required. Rates are calculated using the Kaplan Meier method.|52 weeks|The Full Analysis set (FAS) included all randomized patients who received at least one dose of study medication. Patients were analyzed according to the treatment to which they were randomized||Days||95% Confidence Interval|Median
670610|NCT01697696|Secondary|Change From Baseline in Mean Daily Number of Puffs of Rescue Medication|The number of puffs of rescue medication taken in the previous 12 hours was recorded by the patients in the eDiary in the morning and evening. The total number of puffs of rescue medication per day over the 52 week treatment period was calculated and divided by the total number of days with non-missing rescue data to derive the mean daily number of puffs of rescue medication taken for the patient. If the number of puffs was missing for part of the day (either morning or evening), then a half day was used in the denominator. Change from baseline in number of puffs were analyzed using a linear mixed model which contained treatment, baseline number of puffs, baseline smoking status, baseline ICS use and COPD disease severity as fixed effects with center as a random effect|52 weeks|Only participants from the full analysis set, who had outcome measure data with applicable fixed effects/covariates according to the analysis model, were analyzed.||Number of puffs||Standard Error|Least Squares Mean
670655|NCT01697319|Primary|Change From Baseline in Strength as Assessed by Grip and Pinch Test (GPT)|A grip-strength dynamometer and a pinch meter were used to measure grip strength and pinch strength. The results report change from baseline in strength for dominant and non-dominant hand in a forearm and wrist supported position.|Up to 96 weeks|Modified ITT Population||kg||Standard Deviation|Mean
670611|NCT01697696|Secondary|Change From Baseline in COPD Symptoms|Percentage of days with ‘no daytime symptoms’ A day with ‘no daytime symptoms’ was defined from the diary data as any day where the patient had recorded in the evening no cough, no wheeze, no production of sputum and no feeling of breathlessness (other than when running) and no puffs of rescue medication during the past 12 hours (approximately 8 am to 8pm). However, a patient was not considered symptom free if they had used rescue medication that day even if his/her total daytime symptoms score was zero. Percentage of nights with ‘no nighttime awakenings’ A night with ‘no nighttime awakenings’ was defined from diary data as any night where the patient did not wake up due to symptoms. The total number of nights with ‘no nighttime awakenings’ over the treatment period was divided by the total number of nights where diary recordings had been made in order to derive the percentage nights with ‘no nighttime awakenings’.|52 weeks|Full Analysis set (FAS) included all randomized patients who received at least one dose of study medication. Only participants from the full analysis set, who had outcome measure data with applicable fixed effects/covariates according to the analysis model, were analyzed.||Percentage of days / nights||Standard Error|Least Squares Mean
670612|NCT01697696|Secondary|Change From Baseline in COPD Symptoms|The total symptom score was defined as the sum of individual cores for respiratory symptoms, cough, wheeze, amount of sputum, color of sputum, and reathlessness. Where a patient had a morning score and an evening score for an individual symptom on one particular day then the worst score was to be taken as the daily score for that symptom. Each symptom scale ranged from 0-3 where 0 was no symptoms and 3 was the worst. The total daily/daytime/nighttime symptom score consists of looking at the score for 6 symptoms and can therefore have a minimum score of 0 or a maximum of 18.|52 weeks|Full Analysis set (FAS) included all randomized patients who received at least one dose of study medication. Only participants from the full analysis set, who had outcome measure data with applicable fixed effects/covariates according to the analysis model, were analyzed.”||scores on a scale||Standard Error|Least Squares Mean
670613|NCT01697696|Secondary|Change From Baseline in Pre-dose Forced Vital Capacity (FVC) at All Post-baseline Timepoints|Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FVC was defined as the average of the pre-dose FVC measured at -45 minutes (min) and -15 min at day 1.|-45 min and -15 minutes baseline and at Week 52|Full Analysis set (FAS) included all randomized patients who received at least one dose of study medication. Only participants with baseline and specific post baseline time points were included in the analysis for that time point.||Liters||Standard Deviation|Mean
670614|NCT01697696|Secondary|Change From Baseline in Pre-dose Forced Expiratory Volume (FEV1) in One Second at All Post Baseline Timepoints|Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1.|-45 min and -15 minutes baseline and at Week 52|The Full Analysis set (FAS). At each day/time point, only subjects with a value at both baseline and the respective day/time point are included. Only participants with baseline and specific post baseline time points were included in the analysis for that time point.||Liters||Standard Deviation|Mean
670615|NCT01697696|Secondary|Change From Baseline in Mean Forced Expiratory Volume (Average of the Two FEV1 Measurements 45 and 15 Minutes Pre-dose) in One Second at Week 52|Change from baseline in pre-dose trough FEV1 was analyzed using a repeated measures analysis of covariance model which contained treatment, baseline FEV1, visit, baseline smoking status, baseline ICS use, COPD severity and treatment by visit, visit by baseline FEV1 interactions. An unstructured variance-covariance error matrix was used .Pulmonary function assessments were performed using centralized spirometry according to international standards. Pre-dose trough FEV1 was defined as the mean of FEV1 at -45 min and -15 min before the morning dose at Week 52. Baseline FEV1 was defined as the mean of the pre-dose FEV1 at -45 min and -15 min on Day 1.|-45 min and -15 minutes baseline and at Week 52|The Full Analysis set (FAS) included patients who received at least one dose of study medication. Patients were analyzed according to the treatment to which they were randomized. Only participants from the full analysis set, who had outcome measure data with applicable fixed effects/covariates according to the analysis model, were analyzed.||Liters||Standard Error|Least Squares Mean
670616|NCT01697696|Secondary|Time to Treatment Discontinuation|Discontinuation rates are calculated using the Kaplan Meier method. The protocol allowed patients to discontinue outside the treatment window, hence we have a patient who discontinued at Day 388. Reasons for discontinuing treatment are Subject/guardian decision, Adverse event, Protocol deviation Lack of efficacy, Physician decision, Dosing error, Disease improvement under study, Pregnancy, Technical problems|52 Weeks|The Safety set consisted of all patients that received at least one dose of study medication and had at least one post-baseline safety assessment. Patients were analyzed according to treatment received.||Days||95% Confidence Interval|Median
670617|NCT01697696|Primary|Percentage of Participants Reporting Safety and Tolerability in Terms of Adverse Event (AE) Reporting Rate|Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal lab finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgments of the investigators represent significant hazards.|52 weeks|Safety population - all patients who received at least one dose of study drug whether or not they were randomized. Only patients with safety assessments were included in this analysis||Percentage of participants|||Number
670618|NCT01697592|Secondary|Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24|HbA1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%). Thus, this change from baseline reflects the Week 24 HbA1c minus the Week 0 HbA1c.|Baseline and Week 24|Full Analysis Set (FAS), comprised of all participants who received at least one study drug and have a baseline or post-randomization measurement.||Percent HbA1C||95% Confidence Interval|Least Squares Mean
670656|NCT01697319|Secondary|Percent Change From Baseline in Normalized Urine Keratan Sulfate (uKS)|Urinary keratan sulfate and urinary creatinine were measured through quantitative analysis. uKS is normalized to creatinine.|Up to 96 weeks|Modified ITT Population||% of change||Standard Deviation|Mean
670868|NCT01694108|Secondary|Specific IgE|Number of participants with specific IgE (Phadiatop Infant) above the clinical cut-of level of 0.35.|13 months of age|This analysis includes children who participated with blood samples for this sub-study regarding specific IgE.||participants|||Number
670619|NCT01697592|Primary|Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During the Overall Study|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. Glycemic rescue criteria were: fasting plasma glucose (FPG) of >240 mg/dL, 2 times, (Week 4 to Week 24) and after Week 24, FPG >200 mg/dL, 2 times. Glycemic rescue was achieved through up-titration of basal medication (1st rescue) and through the use of metformin or glimepiride (2nd rescue). These results represent the accrual of events over different treatment intervals: 52 weeks, Omarigliptin (Phase A+B) group, defined as the double-blind period and open-label extension period versus 28 weeks for the placebo switching to Omarigliptin group defined as the open-label extension period only.|Up to 52 weeks|The ASaT population was all randomized participants who received at least one study drug. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data. Data was unavailable for 5 participants who discontinued from the study in the placebo arm in Phase A.||Percentage of participants|||Number
670620|NCT01697592|Primary|Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During Phase A|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to 24 weeks|The ASaT population was defined as all randomized participants who received at least one study drug. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data using the ASaT population.||Percentage of Participants|||Number
670621|NCT01697592|Primary|Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue During the Overall Study|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. Glycemic rescue criteria were: fasting plasma glucose (FPG) of >240 mg/dL, 2 times, (Week 4 to Week 24) and after Week 24, FPG >200 mg/dL, 2 times. Glycemic rescue was achieved through up-titration of basal medication (1st rescue) and through the use of metformin or glimepiride (2nd rescue). These results represent the accrual of events over different treatment intervals: 52 weeks, Omarigliptin (Phase A+B) group, defined as the double-blind period and open-label extension period versus 28 weeks for the placebo switching to Omarigliptin group defined as the open-label extension period only.|Up to 52 weeks|The ASaT population was all randomized participants who received at least one study drug. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data. Data was unavailable for 5 participants who discontinued from the study in the placebo arm in Phase A.||Percentage of participants|||Number
670622|NCT01697592|Primary|Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue During Phase A|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. Glycemic rescue criteria were: fasting plasma glucose (FPG) of >240 mg/dL, 2 times, (Week 4 to Week 24) and after Week 24, FPG >200 mg/dL, 2 times. Glycemic rescue was achieved through up-titration of basal medication (1st rescue) and through the use of metformin or glimepiride (2nd rescue).|Up to 24 weeks|All Subjects as Treated (ASaT) population, defined as all randomized participants who received at least one study drug. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data using the ASaT population.||Percentage of participants|||Number
670623|NCT01697501|Secondary|Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs8099917 at EoT and EoF||EoT and EoF|FAS||percentage of participants|||Number
670624|NCT01697501|Secondary|Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs12979860 at EoT and EoF||EoT and EoF|Full analysis set (FAS), defined as all subjects who completed||percentage of participants|||Number
670625|NCT01697501|Secondary|Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs8099917 at EoT and EoF||EoT and EoF|FAS||percentage of participants|||Number
670626|NCT01697501|Secondary|Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs12979860 at EoT and EoF||EoT and EoF|Full analysis set (FAS), defined as all subjects who completed||percentage of participants|||Number
670627|NCT01697501|Secondary|Percentage of Participants With HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs8099917 at EoT||EoT|FAS||percentage of participants|||Number
670628|NCT01697501|Secondary|Percentage of Participants With HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs12979860 at End of Treatment (EoT)||EoT, as defined in the predecessor study, was at Week 48 or Week 96|Full analysis set (FAS), defined as all subjects who completed||percentage of participants|||Number
670629|NCT01697501|Primary|Percentage of Participants With SVR Defined as HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs8099917 at EoF||EoF|FAS||percentage of participants|||Number
670630|NCT01697501|Primary|Percentage of Participants With Sustained Viral Response (SVR) Defined as HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs12979860 at End of Follow-up (EoF)||EoF, as defined in the predecessor study, was at 48 weeks after the end of treatment.|Full analysis set (FAS), defined as all subjects who completed||percentage of participants|||Number
670631|NCT01697462|Secondary|Number of Participants With Hand-Foot Syndrome (HFS)|HFS, also called palmar-plantar erythrodysesthesia, is a side effect or toxicity associated with specific chemotherapy treatments. The National Cancer Institute (2010) describes it as a condition marked by pain, swelling, numbness, tingling, or redness of the hands or feet.|Baseline up to end of study (up to 42 months)|ITT population.||Participants|||Number
670632|NCT01697462|Secondary|Progression-Free Survival (PFS)|PFS was defined as the period from study entry until disease progression or death from any cause. Disease progression was defined as greater than 20% increase in sum of longest diameter of target lesions compared to baseline.|Baseline to progressive disease or death (up to 42 months)|ITT population. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome.||Months||95% Confidence Interval|Median
672070|NCT01676896|Other Pre-specified|Lung Inflammation, Time 2|Exhaled breath condensation collected and sent for lab analysis of NO3. Data collected at Time 2 visit. Higher values represent greater airway inflammation.|Time 2 at 5 months|||uM||Standard Deviation|Mean
670634|NCT01697462|Primary|Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants with non-serious AEs was exclusive of serious AEs.|Baseline up to end of study (up to 42 months)|Intent-to-treat (ITT) population included all participants who received at least one dose of the study drug and had a subsequent post baseline assessment.||Participants|||Number
670635|NCT01697449|Secondary|Progression Free Survival (PFS)|PFS was defined as the time from the date of informed consent until the date when the participant had progression of disease or died due to any cause. Participants who left the study for reasons other than progression of the disease were censored at the time of their last tumor assessment. Per RECIST, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and non-target lesions) or the unequivocal progression of existing non-target lesions.|Up to 65 months|Included participants who received at least 1 dose of study drug and had postbaseline tumor assessment.||months||95% Confidence Interval|Median
670636|NCT01697449|Secondary|Percentage of Participants With Disease Progression or Death|Per RECIST, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and nontarget lesions) or the unequivocal progression of existing non-target lesions.|Up to 65 months|Included participants who received at least 1 dose of study drug and had postbaseline tumor assessment.||percentage of participants|||Number
670637|NCT01697449|Secondary|Percentage of Participants Who Were Resectable Postbaseline Among the Participants Who Were Unresectable at Baseline||Up to 65 months|Included participants whose CRC was identified as unresectable at baseline.||percentage of participants|||Number
670638|NCT01697449|Secondary|Percentage of Participants With Clinical Benefit of Complete Response [CR], Partial Response [PR] or Stable Disease [SD] Per Response Evaluation Criteria in Solid Tumors (RECIST)|Per RECIST, CR was defined as the disappearance of all target and non-target lesions and normalization of tumor marker level; PR was defined as at least a 30 percentage (%) decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter; SD for target lesions was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started and SD for non-target lesions defined as persistence of 1 or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and nontarget lesions) or the unequivocal progression of existing non-target lesions.|Up to 65 months|All participants who received at least 1 dose of study drug were included in this analysis.||percentage of participants|||Number
670639|NCT01697449|Primary|Percentage of Participants With At Least One Adverse Event (AE)|An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.|Up to 65 months|All participants who received at least 1 dose of study drug and underwent subsequent safety assessment were considered for the safety analysis.||percentage of participants|||Number
670640|NCT01697358|Other Pre-specified|Compare Proportion of Subjects With ≥30% Reduction in Low Back Pain Intensity Between the Treatment Groups|This additional analysis was pre-specified to support the analysis of primary objective. The 30% responder which is defined in the following paragraph was considered as clinical relevant to the SCS therapy in back pain. Compare the proportion of subjects with a ≥30% reduction in low back pain intensity, as measured by the NPRS, from baseline to the end of Period I in the SCS group with that in the OMM group. Subjects reported average low back pain using a 11-point NPRS pain diary (0 = no back pain, 10 = worst low back pain imaginable) two times per day for a 7-day period at baseline and prior to 6-month visit. Percent reduction in low back pain intensity was calculated as average NPRS at (6-month visit - baseline) / baseline. Subjects with ≥30% reduction in average low back pain were considered as 30% responders.|6 months post randomization|As-treated - included all randomized subjects who provided data at 6-month visit, and analyzed based on the actual treatment the subjects received at 6-month visit.||Participants|||Count of Participants
670641|NCT01697358|Secondary|Compare Change in Quality of Life (QoL), as Measured by the SF-36 Physical Component Summary (PCS), Between the Treatment Groups|The QoL scores were collected using the SF-36 questionnaire, which included the scores in the following 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health. The raw score of 0 represents poor health and 100 represents best health. The Physical Component Summary (PCS) score is a norm based score calculated from the raw scores of these 8 domains with a focus on physical health using 1998 US population. Change in PCS is calculated as PCS at 6-month visit - PCS at baseline, with a positive change indicated as an improvement.|6 months post randomization|Intent-to-treat (ITT) - included all randomized subjects and analyzed as randomized, regardless the subjects' status at 6 months. Subjects in the SCS+OMM group received screening tests after the randomization, and might not have proceeded to implant of the neurostimulator. Subjects with missing data at 6 months were imputed as having no change.||units on a scale||Standard Deviation|Mean
670653|NCT01697345|Primary|Total Female Sexual Function Index (FSFI) Score|The Female Sexual Function Index (FSFI) questionnaire was administered to participants prior to starting vaginal testosterone therapy and the survey was repeated after using the study drug for 4 weeks. The participants served as their own controls. The FSFI assesses six domains of sexual functioning (desire, arousal, lubrication, orgasm, satisfaction, and pain) over the past 4 weeks. The sum of all domain scores equals the total FSFI score. The total FSFI score ranges from 2-36 and a total FSFI score < 26.5 suggests female sexual dysfunction.|Baseline, 4 weeks|||units on a scale||Standard Deviation|Mean
670819|NCT01694771|Secondary|Peak FEV1 Response at 12 Weeks - Defined as Change From Baseline|Peak FEV1 (Forced Expiratory Volume in 1 second) response at 12 Weeks - defined as changes from baseline|baseline and 12 weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation at 12 weeks.||L||Standard Error|Least Squares Mean
670642|NCT01697358|Secondary|Compare Change in Functional Disability, as Measured by the Oswestry Disability Index (ODI), Between the Treatment Groups|ODI is a validated questionnaire of 10 subject-reported sections on the ability to perform activities of daily living. These 10 sections are pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life (if applicable), social life, and traveling. Each section was scored on a 0 to 5 scale with 0 indicating no limitation of function due to pain and 5 indicating major functional disability due to back pain. A raw ODI score was calculated from the total score of 10 sections (minimum is 0 and maximum is 50). This ODI raw score was then normalized to a scale of 0 to 100, with 0-20 categorized as minimal disability, 20-40 as moderate disability, 40-60 as severe disability, 60-80 as severely disabled, and 80-100 as bed-bound patients. The ODI was assessed at baseline and subsequent scheduled study visits. Change in functional disability is calculated as ODI at baseline - ODI at 6-month visit, with a positive change indicated as an improvement.|6 months post randomization|Intent-to-treat (ITT) - included all randomized subjects and analyzed as randomized, regardless the subjects' status at 6 months. Subjects in the SCS+OMM group received screening tests after the randomization, and might not have proceeded to implant of the neurostimulator. Subjects with missing data at 6 months were imputed as having no change.||units on a scale||Standard Deviation|Mean
670643|NCT01697358|Secondary|Compare Change in Leg Pain Intensity, as Measured by the NPRS, Between the Treatment Groups|Compare change in leg pain intensity, as measured by the NPRS, from baseline to the end of Period I for subjects in the SCS group with that in the OMM group. Subjects reported average leg pain using a 11-point NPRS pain diary (0 = no back pain, 10 = worst low back pain imaginable) two times per day for a 7-day period at baseline and prior to 6-month visit. Change in leg pain intensity is calculated as NPRS at baseline - NPRS at 6-month visit, with a positive change indicated as an improvement.|6 months post randomization|Intent-to-treat (ITT) - included all randomized subjects and analyzed as randomized, regardless the subjects' status at 6 months. Subjects in the SCS+OMM group received screening tests after the randomization, and might not have proceeded to implant of the neurostimulator. Subjects with missing data at 6 months were imputed as having no change.||units on a scale||Standard Deviation|Mean
670644|NCT01697358|Secondary|Compare Change in Low Back Pain Intensity, as Measured by the Numeric Pain Rating Scale (NPRS), Between the Treatment Groups|Compare change in low back pain intensity, as measured by the Numeric Pain Rating Scale (NPRS), from baseline to the end of Period I for subjects in the SCS group with that in the OMM group. Subjects reported average low back pain using a 11-point NPRS pain diary (0 = no back pain, 10 = worst low back pain imaginable) two times per day for a 7-day period at baseline and prior to 6-month visit. Change in low back pain intensity is calculated as NPRS at baseline - NPRS at 6-month visit, with a positive change indicated as an improvement.|6 months post randomization|Intent-to-treat (ITT) - included all randomized subjects and analyzed as randomized, regardless the subjects' status at 6 months. Subjects in the SCS+OMM group received screening tests after the randomization, and might not have proceeded to implant of the neurostimulator. Subjects with missing data at 6 months were imputed as having no change.||units on a scale||Standard Deviation|Mean
670645|NCT01697358|Primary|Compare Proportion of Subjects With ≥50% Reduction in Low Back Pain Intensity Between the Treatment Groups|Compare the proportion of subjects with a ≥50% reduction in low back pain intensity, as measured by the NPRS, from baseline to the end of Period I in the SCS group with that in the OMM group. Subjects reported average low back pain using a 11-point NPRS pain diary (0 = no back pain, 10 = worst low back pain imaginable) two times per day for a 7-day period at baseline and prior to 6-month visit. Percent reduction in low back pain intensity was calculated as average NPRS at (6-month visit - baseline) / baseline. Subjects with ≥50% reduction in average low back pain were considered as responders.|6 months post randomization|Intent-to-treat (ITT) - included all randomized subjects and analyzed as randomized, regardless the subjects' status at 6 months. Subjects in the SCS+OMM group received screening tests after the randomization, and might not have proceeded to implant of the neurostimulator. Subjects with missing data at 6 months were imputed as non-responders.||Participants|||Count of Participants
670646|NCT01697345|Secondary|Number of Participants Who Continued Vaginal Testosterone Upon Completion of the Study||After 4 weeks|||participants|||Number
670647|NCT01697345|Primary|FSFI Pain Domain|The score for pain is calculated by adding the individual scores from the pain domain (question #17, #18, #19) and multiplying the sum by the domain factor of 0.4. The domain score for pain ranges from 0 (minimum) to 6 (maximum) and a higher value represents a better outcome.|Baseline, 4 weeks|||units on a scale||Standard Deviation|Mean
670648|NCT01697345|Primary|FSFI Satisfaction Domain|The satisfaction score is calculated by adding the individual scores from the satisfaction domain (question #14, #15, #16) and multiplying the sum by the domain factor of 0.4. The satisfaction domain score ranges from 0.8 (minimum) to 6 (maximum) and a higher value represents a better outcome.|Baseline, 4 weeks|||units on a scale||Standard Deviation|Mean
670649|NCT01697345|Primary|FSFI Orgasm Domain|The orgasm score is calculated by adding the individual scores from the orgasm domain (question #11, #12, #13) and multiplying the sum by the domain factor of 0.4. The domain score for orgasm ranges from 0 (minimum) to 6 (maximum) and a higher value represents a better outcome.|Baseline, 4 weeks|||units on a scale||Standard Deviation|Mean
670650|NCT01697345|Primary|FSFI Lubrication Domain|The lubrication score is calculated by adding the individual scores from the lubrication domain (question #7, #8, #9, #10) and multiplying the sum by the domain factor of 0.3. The domain score for lubrication ranges from 0 (minimum) to 6 (maximum) and a higher value represents a better outcome.|Baseline, 4 weeks|||units on a scale||Standard Deviation|Mean
670651|NCT01697345|Primary|FSFI Arousal Domain|The arousal score is calculated by adding the individual scores from the arousal domain (question #3, #4, #5, #6) and multiplying the sum by the domain factor of 0.3. The arousal domain score ranges from 0 (minimum) to 6 (maximum)and a higher value represents a better outcome.|Baseline, 4 weeks|||units on a scale||Standard Deviation|Mean
670652|NCT01697345|Primary|FSFI Desire Domain|The desire score is calculated by adding the individual scores from the desire domain (question #1 and #2) and multiplying the sum by the domain factor of 0.6. The domain score for desire ranges from 1.2 (minimum) to 6 (maximum) and a higher value represents a better outcome.|Baseline, 4 weeks|||units on a scale||Standard Deviation|Mean
670820|NCT01694771|Primary|Trough FEV1 Response at 12 Weeks; Defined as Change From Baseline to Week 12|Trough FEV1 (Forced expiratory volume in 1 second) response at 12 weeks; defined as change from baseline to Week 12|baseline and 12 weeks|Full Analysis set (FAS) with last observation carried forward (LOCF) imputation at 12 weeks.||L||Standard Error|Least Squares Mean
670657|NCT01697319|Primary|Percent Change From Baseline in Speed as Measured in Functional Dexterity Test (FDT)|FDT assesses the ability to use the hand in daily tasks. The test involves turning 16 wooden pegs over as quickly as possible on a hardwood pegboard with one hand requiring a three-jaw chuck prehension pattern between the fingers and thumb within a two-minute time limit. Hand function is evaluated by how fast a patient can turn over pegs in the given time limit, i.e. speed (number of pegs/minute).|Up to 96 weeks|Modified ITT Population||% of change||Standard Deviation|Mean
670658|NCT01696994|Secondary|T5 CA-125 Screening Results|Cancer Antigen 125 (CA-125) result.|T5 (five years after entry)|Females in the Ovarian Screening arm (excluding females with no ovaries at baseline) who had a CA-125 screen at T5 were analyzed.||Participants|||Number
670659|NCT01696994|Secondary|T4 CA-125 Screening Results|Cancer Antigen 125 (CA-125) result.|T4 (four years after entry)|Females in the Ovarian Screening arm (excluding females with no ovaries at baseline) who had a CA-125 screen at T4 were analyzed.||Participants|||Number
670660|NCT01696994|Primary|Ovarian Cancer Death Rates (Including Primary Peritoneal and Fallopian Tube Cancers)|Ovarian cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate. Rate is the number of deaths divided by person years of follow-up in the study.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.|Female participants, excluding females without ovaries at baseline, were analyzed. An intention-to-treat analysis was performed.||Deaths per 10,000 PY|||Number
670661|NCT01696994|Secondary|T3 TVU Screening Results|Transvaginal Ultrasound (TVU) result.|T3 (three years after entry)|Females in the Ovarian Screening arm (excluding females with no ovaries at baseline) who had a TVU screen at T3 were analyzed.||Participants|||Number
670662|NCT01696994|Secondary|T3 CA-125 Screening Results|Cancer Antigen 125 (CA-125) result.|T3 (three years after entry)|Females in the Ovarian Screening arm (excluding females with no ovaries at baseline) who had a CA-125 screen at T3 were analyzed.||Participants|||Number
670663|NCT01696994|Secondary|T2 TVU Screening Results|Transvaginal Ultrasound (TVU) result.|T2 (one year after entry)|Females in the Ovarian Screening arm (excluding females with no ovaries at baseline) who had a TVU screen at T2 were analyzed.||Participants|||Number
670664|NCT01696994|Secondary|T2 CA-125 Screening Results|Cancer Antigen 125 (CA-125) result.|T2 (two years after entry)|Females in the Ovarian Screening arm (excluding females with no ovaries at baseline) who had a CA-125 screen at T2 were analyzed.||Participants|||Number
670665|NCT01696994|Secondary|T1 TVU Screening Results|Transvaginal Ultrasound (TVU) result.|T1 (one year after entry)|Females in the Ovarian Screening arm (excluding females with no ovaries at baseline) who had a TVU screen at T1 were analyzed.||Participants|||Number
670666|NCT01696994|Secondary|T1 CA-125 Screening Results|Cancer Antigen 125 (CA-125) result.|T1 (one year after entry)|Females in the Ovarian Screening arm (excluding females with no ovaries at baseline) who had a CA-125 screen at T1 were analyzed.||Participants|||Number
670667|NCT01696994|Secondary|T0 (Baseline) TVU Screening Results|Transvaginal Ultrasound (TVU) result.|T0 (at study entry)|Females in the Ovarian Screening arm (excluding females with no ovaries at baseline) who had a TVU screen at T0 were analyzed.||Participants|||Number
670668|NCT01696994|Secondary|T0 (Baseline) CA-125 Screening Results|Cancer Antigen 125 (CA-125) result.|T0 (at study entry)|Females in the Ovarian Screening arm (excluding females with no ovaries at baseline) who had a CA-125 screen at T0 were analyzed.||Participants|||Number
670669|NCT01696994|Secondary|Complications of Diagnostic Evaluation (DE) Following a Positive Screening Test|Number of positive screens with complications|One year from screening examination|The units analyzed were positive screening exams with documented diagnostic follow-up. If a participant received 3 positive screens with documented follow-up after each one, she would be counted 3 times in the number of units analyzed.||Positive screens w/ complications|Positive Screens with Follow-up||Number
670670|NCT01696994|Secondary|Ovarian Cancer Incidence Rates (Including Primary Peritoneal and Fallopian Tube Cancers).|Ovarian cancer diagnoses confirmed by medical record abstraction. Incidence rate (cumulative) defined as ovarian cancer diagnoses divided by person years at risk for ovarian cancer.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.|Female participants, excluding females without ovaries at baseline, were analyzed. An intention-to-treat analysis was performed.||Diagnoses per 10,000 PY|||Number
670671|NCT01696994|Secondary|Ovarian Cancer Incidence (Including Primary Peritoneal and Fallopian Tube Cancers)|Ovarian cancer diagnoses confirmed by medical record abstraction.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.|Female participants, excluding females without ovaries at baseline, were analyzed. An intention-to-treat analysis was performed.||Participants|||Number
670672|NCT01696994|Secondary|Death Rates From All Causes|Deaths from all causes were compared between the ovarian cancer screening arm and the usual care arm. Rate is the number of deaths divided by person years of follow-up in the study.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.|Female participants, excluding females without ovaries at baseline, were analyzed. An intention-to-treat analysis was performed.||Deaths per 10,000 PY|||Number
670673|NCT01696994|Secondary|Deaths From All Causes|Deaths from all causes were compared between the ovarian cancer screening arm and the usual care arm.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.|||Participants|||Number
670674|NCT01696994|Primary|Ovarian Cancer Deaths (Including Primary Peritoneal and Fallopian Tube Cancers)|Ovarian cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.|||Participants|||Number
670675|NCT01696981|Secondary|T3/T5 FSG Screening Result|Flexible sigmoidoscopy (FSG) result|T3 (three years after entry) or T5 (five years after entry)|All participants in the Colorectal Screening arm who had an FSG at T0 or T3 were analyzed.||Participants|||Number
670676|NCT01696981|Secondary|T0 (Baseline) FSG Screening Results|Flexible sigmoidoscopy (FSG) result|T0 (at study entry)|All participants in the Colorectal Screening arm who had an FSG at T0 were analyzed.||Participants|||Number
670677|NCT01696981|Primary|Colorectal Cancer Death Rates|Colorectal cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate. Rate is the number of deaths divided by person years of follow-up in the study.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years.|||Deaths per 10,000 PY|||Number
670678|NCT01696981|Secondary|Complications of Diagnostic Evaluation Following a Positive Screening Test|Number of participants who experienced complications during diagnostic work-up of a positive colorectal examination.|One year from screening examination|The units analyzed were positive screening exams with documented diagnostic follow-up. If a participant received 2 positive screens with documented follow-up after each one, he would be counted 2 times in the number of units analyzed.||Positive screens w/ complications|Positive Screens with Follow-up||Number
670679|NCT01696981|Secondary|Colorectal Cancer Incidence Rates|Colorectal cancer diagnoses confirmed by medical record abstraction. Incidence rate (cumulative) defined as colorectal cancer diagnoses divided by person years at risk for colorectal cancer.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years.|All participants. An intention-to-treat analysis was performed.||Diagnoses per 10,000 PY|||Number
670680|NCT01696981|Secondary|Colorectal Cancer Incidence|Colorectal cancer diagnoses confirmed by medical record abstraction.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years.|All participants. An intention-to-treat analysis was performed.||Participants|||Number
670681|NCT01696981|Secondary|Death Rates From All Causes|Deaths from all causes were compared between the colorectal cancer screening arm and the usual care arm. Rate is the number of deaths divided by person years of follow-up in the study.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years.|All participants. An intention-to-treat analysis was performed.||Deaths per 10,000 PY|||Number
670682|NCT01696981|Secondary|Deaths From All Causes|Deaths from all causes were compared between the colorectal cancer screening arm and the usual care arm.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years.|All participants. An intention-to-treat analysis was performed.||Participants|||Number
670683|NCT01696981|Primary|Colorectal Cancer Deaths|Colorectal cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years.|||Participants|||Number
670684|NCT01696968|Secondary|T3 CXR Screening Results|Postero-anterior view chest radiograph (CXR) result|T3 (three years after entry)|All participants in the Lung Screening arm who had a CXR screen at T3 were analyzed.||Participants|||Number
670685|NCT01696968|Secondary|T2 CXR Screening Results|Postero-anterior view chest radiograph (CXR) result|T2 (two years after entry)|All participants in the Lung Screening arm who had a CXR screen at T2 were analyzed.||Participants|||Number
670686|NCT01696968|Primary|Lung Cancer Death Rates|Lung cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate. Rate is the number of deaths divided by person years of follow-up in the study.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.|||Deaths per 10,000 PY|||Number
670687|NCT01696968|Secondary|T1 CXR Screening Results|Postero-anterior view chest radiograph (CXR) result|T1 (one year after entry)|All participants in the Lung Screening arm who had a CXR screen at T1 were analyzed.||Participants|||Number
670688|NCT01696968|Secondary|T0 (Baseline) CXR Screening Results|Postero-anterior view chest radiograph (CXR) result|T0 (at study entry)|All participants in the Lung Screening arm who had a CXR screen at T0 were analyzed.||Participants|||Number
670689|NCT01696968|Secondary|Complications of Diagnostic Evaluation Following a Positive Screening Test|Number of positive screens with complications.|One year from screening examination|The units analyzed were positive screening exams with documented diagnostic follow-up. If a participant received 3 positive screens with documented follow-up after each one, he would be counted 3 times in the number of units analyzed.||Positive screens w/ complications|Positive Screens with Follow-up||Number
670690|NCT01696968|Secondary|Lung Cancer Incidence Rates|Lung cancer diagnoses confirmed by medical record abstraction. Incidence rate (cumulative) defined as lung cancer diagnoses divided by person years at risk for lung cancer.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.|All participants were analyzed. An intention-to-treat analysis was performed.||Diagnoses per 10,000 PY|||Number
670691|NCT01696968|Secondary|Lung Cancer Incidence|Lung cancer diagnoses confirmed by medical record abstraction.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.|All participants were analyzed. An intention-to-treat analysis was performed.||Participants|||Number
670692|NCT01696968|Secondary|Death Rates From All Causes|Deaths from all causes were compared between the lung screening arm and the usual care arm. Rate is the number of deaths divided by person years of follow-up in the study.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.|All participants were analyzed. An intention-to-treat analysis was performed.||Deaths per 10,000 PY|||Number
670693|NCT01696968|Secondary|Deaths From All Causes|Deaths from all causes were compared between the lung screening arm and the usual care arm.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.|All participants were analyzed. An intention-to-treat analysis was performed.||Participants|||Number
670694|NCT01696968|Primary|Lung Cancer Deaths|Lung cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.|All participants were analyzed. An intention-to-treat analysis was performed.||Participants|||Number
670720|NCT01696357|Primary|Average Number of Coughs Per Hour|The device is supposed to detect and count the number of coughs per 24 hours and register the numbers into the device.|7 days|One subject in the non-asthma group failed to return the device after the 7-trial. Data from 22 participants (3 from the asthma group, 19 from non-asthma group) were not included in the analysis as no data were recorded (due to a mechanical issue) or data were too extreme (due to cough algorithm failure).||average number of coughs per hour||Standard Deviation|Mean
670697|NCT01696929|Secondary|Change in Total Psychotic Symptoms|The Positive and Negative Symptoms Scale (PANSS) is the metric used to characterize psychotic symptoms in this study. The PANSS consists of 30 items, each scored 1-7. The range for the PANSS total score is 30-210. There are 3 subscales - PANSS positive score (range 7-49), PANSS negative score (range 7-49), and PANSS general score (range 16-112). PANSS total score is the summation of these 3 subscales. Higher values for the total and subscale scores reflect more severe psychopathology. A positive change in PANSS total score reflects an increase in psychopathology. A negative change in PANSS total score reflects a decrease in psychopathology.|Change in PANSS total score from baseline to 8 weeks|||Change in PANSS Total Score||Standard Deviation|Mean
670698|NCT01696929|Primary|Change in Cognition|The Brief Assessment of Cognition in Schizophrenia (BACS) is the metric used to characterize cognition in this study. The BACS consists of 6 subscales: Verbal Memory (range 0-75), Working Memory (range 0-28), Motor Speed (range 0-100), Verbal Fluency (measure is total number of words generated in two 60 second trials), Attention and Processing speed (range 0-110), and Executive Function (range 0-22). For each subscale, higher scores reflect better cognition. For each subscale, a Standard Deviation Score was calculated based on normative data (Keefe et al. Norms and standardization of the Brief Assessment of Cognition in Schizophrenia (BACS). Schizophrenia Research 102 (2008) 108–115). The BACS composite score is calculated as the average Standard Deviation Score of the 6 subscale scores. The change in BACS composite score was calculated as the BACS composite score at 8 weeks minus the BACS composite score at baseline.|Change in BACS composite score from baseline to 8 weeks|||Change in BACS Composite Score||Standard Deviation|Mean
670699|NCT01696773|Primary|Pharmacokinetics of Carotenoid Absorption|The primary goal of this research is to determine if a processed tangerine tomato product has enhanced bioavailability of carotenoids and flavonoids compared to a commercially available processed red tomato product in humans. An area under the curve for concentration of carotenoids (from triglyceride rich lipoprotein (TRL) fraction of plasma) by using carotenoid concentrations from hours 0, 2, 3, 4, 5, 6, 8, 10 and 12 over time to quantify absorption, after subjects consume a meal containing tangerine or red tomato juice.|11 post-prandial blood samples will be taken over 12 hours|||nmol*h/L||Standard Error|Mean
670700|NCT01696760|Secondary|Death Rate||Up to 3 months|||participants|||Number
670701|NCT01696760|Secondary|Excessive Wound Drainage||Up to 3 months|||participants|||Number
670702|NCT01696760|Secondary|Hematoma Formation||Up to 3 months|||participants|||Number
670703|NCT01696760|Secondary|Readmission Rate to Hopsital||Up to 3 months|||participants|||Number
670704|NCT01696760|Secondary|Development of Other Complications (Including Bleeding Complications)||Up to 3 months|||participants|||Number
670705|NCT01696760|Secondary|Pulmonary Embolism Rate||Up to 3 months|||participants|||Number
670706|NCT01696760|Primary|DVT Incident Rate|This study will test if the ASA+PCD treatment group has a DVT rate (P1) not more than the DVT rate of the LMWH+PCD treatment group (P0) using a one sided test for these two proportions. Statistical significance will be defined as p < 0.05.|Up to 3 months|||participants|||Number
670707|NCT01696695|Secondary|Percentage of Participants With Dose Modification of Capecitabine||Baseline up to 1254 days|ITT Population.||Percentage of participants|||Number
670708|NCT01696695|Secondary|Mean Duration of Capecitabine Therapy||Baseline up to 1254 days|ITT Population. Here, N (number of participants analyzed) indicates the total number of participants who provided evaluable data for this outcome measure.||Days||Standard Deviation|Mean
670709|NCT01696695|Secondary|Percentage of Participants Who Underwent Metastasectomy|Metastasectomy is the surgical removal of metastases, which are secondary cancerous growths that have spread from cancer originating in another organ in the body.|Baseline up to 1254 days|ITT Population. Here, N (number of participants analyzed) indicates the total number of participants who provided evaluable data for this outcome measure.||Percentage of participants||95% Confidence Interval|Number
670710|NCT01696695|Secondary|Percentage of Participants With Clinical Benefit as Assessed Using RECIST v1.1|Clinical benefit was defined as having a confirmed CR, PR or stable disease (SD) for at least 24 weeks on study according to RECIST v1.1.CR: complete disappearance of all target lesions and non-target disease,with the exception of nodal disease.All nodes,both target and non-target, must decrease to normal (short axis <10 mm).No new lesions.PR: >=30% decrease under baseline of the sum of diameters of all target lesions.The short axis was used in the sum for target nodes,while the longest diameter was used in the sum for all other target lesions.No unequivocal progression of non-target disease.No new lesions.SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD,taking as reference the smallest sum diameters while on study.PD:at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions,or presence of new lesions.|Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first, evaluated up to Day 1254|ITT Population.||Percentage of participants||95% Confidence Interval|Number
670711|NCT01696695|Secondary|Percentage of Participants With Overall Response as Assessed by Investigator Using RECIST v1.1|Overall response is defined as a complete response (CR) or a partial response (PR) as determined by the Investigator using RECIST v1.1 on 2 consecutive occasions at least 6 weeks apart. Participants were evaluated for tumor response per RECIST v1.1 and assessed by computed tomography (CT) or magnetic resonance imaging (MRI):CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than (<) 10 mm). No new lesions.PR was defined as greater than or equal to (>=) 30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.|Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first, evaluated up to Day 1254|ITT population.||Percentage of participants||95% Confidence Interval|Number
670721|NCT01696214|Secondary|Physiologic Measures Were Determined at the Initial Visit, at Randomization Following a wash-in Period of 1 Month, Monthly for 24 Weeks and0 That a Follow-up Visit 1 Month Off Study Drug. Mean Scores Over the 24 Weeks of Treatment Were Compared.|Physiologic measures of FEV1, FVC and FEV1/FVC ratio|At each visit||||||
670835|NCT01694641|Primary|Pregnancy Rate|rise in beta HCG 12-14 days after transfer|12-14 days after transfer|All patients randomized are analyszs (intention to treat analysis).||Participants|||Count of Participants
670712|NCT01696695|Primary|PFS by Therapeutic Regimens|PFS was assessed using RECIST v1.1 and is defined as the time from the first dose of indicated treatment to PD or death, whichever occurred first. Participants who did not progress or died while being followed were censored on the date of the last visit. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm; progression of existing non-target lesions; or presence of new lesions. Median PFS was estimated using Kaplan-Meier method.|Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first, evaluated up to Day 1254|ITT Population. Here, number (n)= number of participants evaluable for the specified therapeutic regimen.||Days||95% Confidence Interval|Median
670713|NCT01696695|Primary|Median Progression-free Survival (PFS)|PFS was assessed using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) and is defined as the time from the first dose of indicated treatment to disease progression (PD) or death, whichever occurred first. Participants who did not progress or died while being followed were censored on the date of the last visit. Participants without post-baseline tumor assessments were conservatively censored on the date of first study medication, which is PFS was assigned a value of 1 day. PD: at least 20 percent (%) increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 millimeter (mm); progression of existing non-target lesions; or presence of new lesions. Median PFS was estimated using Kaplan-Meier method.|Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first, evaluated up to Day 1254|ITT Population||Days||95% Confidence Interval|Median
670714|NCT01696643|Other Pre-specified|Number of Participants With Adjudicated Cardiovascular, Gastrointestinal, or Central Opioid Withdrawal Events|"Cardiovascular (CV) events of interested included mycardial infarction, unstable angina, CV accident, congestive heart failure, serious arrhythmia, resuscitated cardiac arrest, and death.
Gastrointestinal (GI) events of interest included emergency department visits for the serious adverse events of gastroenteritis, hepatitis, pancreatitis, nausea, vomiting, diarrhea, and abdominal pain or cramping.
Central opioid withdrawal (OW) events of interest included opioid withdrawal syndrome. The adverse events that indicated central OW included, but were not limited to, hyperhidrosis, tremor, dysphoria, and myalgia.
The number of participants with at least 1 confirmed CV, GI, or Central OW event is presented."|Baseline through Week 56|All randomized participants who received at least 1 dose of study drug. Two participants were randomized to the Placebo Arm but were administered CB-5945 instead. As a result, these 2 participants were included in the CB-5945 Arm for analysis.||participants|||Number
670715|NCT01696643|Secondary|Plasma Trough Concentrations of CB-5945|Blood samples for trough concentrations of CB-5945 were collected before the participant's morning dose of study drug at Weeks 4, 12, 24, 36, and 52. Overall concentration was based on the mean trough level for each participant across all weeks.|Weeks 4, 12, 24, 36, and 52|All participants randomized to CB-5945 who received at least 1 dose of study drug and had evaluable CB-5945 concentration data. Two participants were randomized to the Placebo Arm but were administered CB-5945 instead. As a result, these 2 participants were included in the CB-5945 Arm for analysis.||picograms per milliliter (pg/mL)||Standard Deviation|Mean
670716|NCT01696643|Secondary|Change From Baseline in Patient-Reported Constipation Severity Assessment (PCSA) at Week 52|The PCSA asked participants to rate the severity of their overall constipation during the 24 hours prior to the assessment, using a scale of 0 to 10, where 0 is no constipation and 10 is the worst constipation imaginable.|Baseline, Week 52|All randomized participants who received at least 1 dose of study drug and had evaluable PCSA data. Two participants were randomized to the Placebo Arm but were administered CB-5945 instead. As a result, these 2 participants were included in the CB-5945 Arm for analysis.||units on a scale||Standard Deviation|Mean
670717|NCT01696643|Secondary|Change From Baseline in Patient Assessment of Constipation-Quality of Life (PAC-QOL) Questionnaire at Week 52|The PAC-QOL questionnaire contains a total of 28 items, each rated within 4 subscales: physical discomfort, psychosocial discomfort, worries and concerns, and satisfaction. Each item was rated on a 5-point Likert scale with the following score definitions, depending on the question: 0 = not at all (or none of the time), 1 = a little bit (or a little of the time), 2 = moderately (or some of the time), 3 = quite a bit (or most of the time), and 4 = extremely (or all of the time). The total score is the mean of all non-missing items. The range of the total score is 0 (response is 'not at all' for each item) to 4 (response is 'extremely' for each item). Negative change from baseline values indicate improvement in constipation quality of life. Each participant completed the PAC-QOL at Baseline and Week 52 using a 2-week recall period.|Baseline, Week 52|All randomized participants who received at least 1 dose of study drug and had evaluable PAC-QOL data. Two participants were randomized to the Placebo Arm but were administered CB-5945 instead. As a result, these 2 participants were included in the CB-5945 Arm for analysis.||units on a scale||Standard Deviation|Mean
670718|NCT01696643|Secondary|Change From Baseline in Mean Daily Opioid Dose at Weeks 49-52|Throughout the study, participants were asked to record changes in maintenance opioid consumption and use of opioid analgesics for breakthrough or exacerbation of pain in a paper diary. Opioid consumption (including rescue opioids) of each participant was converted to an oral morphine-equivalent total daily dose (METDD). Opioid consumption (in milligrams of METDD) was summarized in 4-week intervals. The change from baseline to Weeks 49-52 is summarized.|Baseline, Weeks 49-52|All randomized participants who received at least 1 dose of study drug and had evaluable METDD data. Two participants were randomized to the Placebo Arm but were administered CB-5945 instead. As a result, these 2 participants were included in the CB-5945 Arm for analysis.||milligrams of METDD||Standard Deviation|Mean
670719|NCT01696643|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)|A TEAE was defined as any adverse event (AE) that occurred from the time of first dose of the study drug through the last study evaluation or pre-existing AEs that were aggravated in severity or frequency during the dosing period. The percentages of participants with at least 1 TEAE, with at least 1 drug-related TEAE (drug-related included “possibly related” or “related” as deemed by the Investigator; it also included events if causality was missing), and who discontinued from treatment due to a TEAE are presented. A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.|Baseline through Week 56|All randomized participants who received at least 1 dose of study drug. Two participants were randomized to the Placebo Arm but were administered CB-5945 instead. As a result, these 2 participants were included in the CB-5945 Arm for analysis.||percentage of participants|||Number
670722|NCT01696214|Secondary|The Asthma Symptom Utility Index(AUSI)|The Asthma Symptom Utility Index (AUSI), an important secondary outcome in the proposed full-scale TOM Trial, has also been shown to be useful in tracking the frequency and severity of asthma-related symptoms in non-smoking asthmatics.|Outcome measures were determined at the initial visit, at randomization following a wash-in period of 1 month, monthly for 24 weeks and0 that a follow-up visit 1 month off study drug. Mean scores over the 24 weeks of treatmen||||||
670723|NCT01696214|Primary|Asthma Control Test|The primary symptomatic measure, the Asthma Control Test (ACT), has been shown to be valid for measuring poor asthma control in asthmatic children and non-smoking adults. The ACT is a tool developed by Nathan and collaborators a decade ago for evaluating asthma control. It consists of five questions with five possible answers each. A maximum score of 25 points indicates complete asthma control. A score between 20 and 24 represents partially controlled asthma, while a score 19 or below indicates poorly controlled asthma and a score <16 indicates uncontrolled asthma. The minimally important clinical difference has been determined to be 3.|Outcome measures were determined at the initial visit, at randomization following a wash-in period of 1 month, monthly for 24 weeks and0 that a follow-up visit 1 month off study drug. Mean scores over the 24 weeks of treatment were compared.|||units on a scale||Full Range|Median
670724|NCT01696188|Secondary|Time for Block Placement|Calculate the time to perform the nerve block procedure.|immediately post-procedure|||seconds||95% Confidence Interval|Mean
670725|NCT01696188|Secondary|Opioid Consumption|Calculate the total amount of opioid consumed in the first 48 hours after surgery using a standard opioid conversion scale. 1 mg hydrocodone = 0.33 mg IV morphine, 1 mg oxycodone = 0.50 mg morphine IV, 1 mg hydromorphone PO = 1.33 mg morphine IV, 1 mcg fentanyl = 0.1 mg morphine IV, 1 mg hydromorphone IV = 6.67 mg morphine IV|48 hours|||mg IV morphine equivalents||Inter-Quartile Range|Median
670726|NCT01696188|Secondary|Catheter Dislodgements|Inspect the peripheral nerve catheters at 24 hours postoperatively and assess for being in-place or not.|24 hours|||participants|||Number
670727|NCT01696188|Primary|Visual Analog Scale Pain Scores|Pain was rated from 0 (no pain) to 10 (worst pain imaginable)|24 hours|||units on a scale||Inter-Quartile Range|Median
670728|NCT01696084|Secondary|Proportion of Subjects Receiving a Stem Cell Transplant|The number and percentage of subjects transferred for HSCT after induction treatment was recorded.|Post Induction|Intent-to-Treat (ITT) Population: All participants randomized in the study.||Participants|||Count of Participants
670729|NCT01696084|Secondary|Rate of Achieving Morphologic Leukemia-free State|All randomized subjects with at least 1 evaluable postrandomization bone marrow assessment performed on or after Day 14 after the last induction were assessed for MLFS.|Day 14|Intent-to-Treat (ITT) Population: All participants randomized in the study.||Participants|||Count of Participants
670730|NCT01696084|Secondary|Remission Duration|Only subjects achieving CR or CRi were assessed for remission duration.|From the date of achievement of a remission until the date of relapse or death from any cause|Intent-to-Treat (ITT) Population: All participants randomized in the study.||months||95% Confidence Interval|Median
670731|NCT01696084|Secondary|Event-free Survival|All randomized subjects were assessed for event-free survival (EFS). EFS was defined as the time from study randomization to the date of induction treatment failure (persistent disease), relapse from CR or CRi or death from any cause, whichever came first. Subjects alive and not known to have any of these events were censored on thee date they were last examined on study.|From the date of randomization to the date that persistent disease was documented or the date of relapse after CR or death, whichever came first|Intent-to-Treat (ITT) Population: All participants randomized in the study.||months||95% Confidence Interval|Median
670732|NCT01696084|Secondary|Proportion of Subjects With a Response|Complete Remission (CR)|Post Induction|Intent-to-Treat (ITT) Population: All participants randomized in the study.||Participants|||Count of Participants
670733|NCT01696084|Primary|Overall Survival|Overall survival was measured from the date of randomization to death from any cause, subjects not known to have died by the last follow-up were censored on the date they were last known to be alive.|From the date of randomization to death from any cause|Intent-to-Treat (ITT) Population: All participants randomized in the study.||months||95% Confidence Interval|Median
670734|NCT01696071|Secondary|Peak Expiratory Flow (PEF) AUC0-24h Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline.Measured following the respective dosing determined at the end of each 4 week period of randomised treatment. AUC0-24h calculated using the trapezoidal rule divided by the observation time (24 hours) to report in litres per minute.|Baseline taken at visit 2 prior to the first evening dose of randomised study medication. Then, 10 minutes(min) prior to dose to 30min,1hour(h),2h,3h,4h,11h50min,12h30min,13h,14h,15h,16h,18h,20h,22h and 23h,23h50min relative to dose after 4 weeks|Full Analysis Set (FAS): The full analysis set (FAS) includes all patients in the treated set who had baseline data and at least one on-treatment efficacy value after 4 weeks on treatment within a period.||Litres/min||Standard Error|Least Squares Mean
670735|NCT01696071|Secondary|Trough FVC Responses|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline.Measured following the respective dosing determined at the end of each 4 week period of randomised treatment. Trough FVC was defined as the FVC value just prior to the last evening dose of study medication.|Baseline taken at visit 2 prior to the first evening dose of randomised study medication. Then, 10 minutes(min) prior to dose after 4 weeks|Full Analysis Set (FAS): The full analysis set (FAS) includes all patients in the treated set who had baseline data and at least one on-treatment efficacy value after 4 weeks on treatment within a period.||Litres||Standard Error|Least Squares Mean
670736|NCT01696071|Secondary|Peak FVC Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline.Measured following the respective dosing determined at the end of each 4 week period of randomised treatment. Peak FVC was defined as the highest FVC reading observed within the 24 hour period following inhalation of the last evening dose of study medication (FVC Peak0-24h).|Baseline taken at visit 2 prior to the first evening dose of randomised study medication. Then, 10 minutes(min) prior to dose to 30min,1hour(h),2h,3h,4h,11h50min,12h30min,13h,14h,15h,16h,18h,20h,22h and 23h,23h50min relative to dose after 4 weeks|Full Analysis Set (FAS): The full analysis set (FAS) includes all patients in the treated set who had baseline data and at least one on-treatment efficacy value after 4 weeks on treatment within a period.||Litres||Standard Error|Least Squares Mean
670836|NCT01694420|Other Pre-specified|Number of Participants With Adverse Events Related to Study Drug||48 weeks|||participants|||Number
670737|NCT01696071|Secondary|FVC AUC12-24h Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline.Measured following the respective dosing determined at the end of each 4 week period of randomised treatment. AUC12 -24h calculated using the trapezoidal rule divided by the observation time (12 hours) to report in litres.|Baseline taken at visit 2 prior to the first evening dose of randomised study medication. Then, 10 minutes(min) prior to dose to 30min,1hour(h),2h,3h,4h,11h50min,12h30min,13h,14h,15h,16h,18h,20h,22h and 23h,23h50min relative to dose after 4 weeks|Full Analysis Set (FAS): The full analysis set (FAS) includes all patients in the treated set who had baseline data and at least one on-treatment efficacy value after 4 weeks on treatment within a period.||Litres||Standard Error|Least Squares Mean
670738|NCT01696071|Secondary|FVC AUC0-12h Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Measured following the respective dosing determined at the end of each 4 week period of randomised treatment. AUC0-12h calculated using the trapezoidal rule divided by the observation time (12 hours) to report in litres.|Baseline taken at visit 2 prior to the first evening dose of randomised study medication. Then, 10 minutes(min) prior to dose to 30min,1hour(h),2h,3h,4h,11h50min,12h30min,13h,14h,15h,16h,18h,20h,22h and 23h,23h50min relative to dose after 4 weeks|Full Analysis Set (FAS): The full analysis set (FAS) includes all patients in the treated set who had baseline data and at least one on-treatment efficacy value after 4 weeks on treatment within a period.||Litres||Standard Error|Least Squares Mean
670739|NCT01696071|Secondary|Forced Vital Capacity (FVC) AUC0-24h Response|"MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline.Measured following the respective dosing determined at the end of each 4 week period of randomised treatment. AUC0-24h calculated using the trapezoidal rule divided by the observation time (24 hours) to report in litres.
The values recorded at 11 hours 50 minutes and at 23 hours 50 minutes post dosing were assigned to 12 and 24 hours, respectively."|Baseline taken at visit 2 prior to the first evening dose of randomised study medication. Then, 10 minutes(min) prior to dose to 30min,1hour(h),2h,3h,4h,11h50min,12h30min,13h,14h,15h,16h,18h,20h,22h and 23h,23h50min relative to dose after 4 weeks|Full Analysis Set (FAS): The full analysis set (FAS) includes all patients in the treated set who had baseline data and at least one on-treatment efficacy value after 4 weeks on treatment within a period.||Litres||Standard Error|Least Squares Mean
670740|NCT01696071|Secondary|Trough FEV1 (L) Response.|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline.Measured following the respective dosing determined at the end of each 4 week period of randomised treatment. Trough FEV1 was defined as the FEV1 value just prior to the last evening dose of study medication.|10 minutes (min) prior to dose after 4 weeks|Full Analysis Set (FAS): The full analysis set (FAS) includes all patients in the treated set who had baseline data and at least one on-treatment efficacy value after 4 weeks on treatment within a period.||Litres||Standard Error|Least Squares Mean
670741|NCT01696071|Secondary|Peak FEV1 Response.|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline.Measured following the respective dosing determined at the end of each 4 week period of randomised treatment. Peak FEV1 was defined as the highest FEV1 reading observed within the 24 hour period following inhalation of the last evening dose of study medication (FEV1 Peak0-24h). The values recorded at 11 hours 50 minutes and at 23 hours 50 minutes post dosing were assigned to 12 and 24 hours, respectively.|10 minutes (min) prior to dose to 30 min,1 hour (h),2h,3h,4h,11h50min,12h30min,13h,14h,15h,16h,18h,20h,22h and 23h,23h50min relative to dose after 4 weeks.|Full Analysis Set (FAS): The full analysis set (FAS) includes all patients in the treated set who had baseline data and at least one on-treatment efficacy value after 4 weeks on treatment within a period.||Litres||Standard Error|Least Squares Mean
670742|NCT01696071|Secondary|FEV1 AUC12-24h Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Measured following the respective dosing determined at the end of each 4 week period of randomised treatment. AUC12 -24h calculated using the trapezoidal rule divided by the observation time (12 hours) to report in litres.|Baseline FEV1 taken at visit 2 prior to the first evening dose of randomised study medication. Then, 10 minutes(min) prior to dose to 30min,1hour(h),2h,3h,4h,11h50min,12h30min,13h,14h,15h,16h,18h,20h,22h and 23h,23h50min relative to dose after 4 weeks|Full Analysis Set (FAS): The full analysis set (FAS) includes all patients in the treated set who had baseline data and at least one on-treatment efficacy value after 4 weeks on treatment within a period.||Litres||Standard Error|Least Squares Mean
670743|NCT01696071|Secondary|FEV1 AUC0-12h Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Measured following the respective dosing determined at the end of each 4 week period of randomised treatment. AUC0-12h calculated using the trapezoidal rule divided by the observation time (12 hours) to report in litres.|Baseline FEV1 taken at visit 2 prior to the first evening dose of randomised study medication. Then, 10 minutes(min) prior to dose to 30min,1hour(h),2h,3h,4h,11h50min,12h30min,13h,14h,15h,16h,18h,20h,22h and 23h,23h50min relative to dose after 4 weeks|Full Analysis Set (FAS): The full analysis set (FAS) includes all patients in the treated set who had baseline data and at least one on-treatment efficacy value after 4 weeks on treatment within a period.||Litres||Standard Error|Least Squares Mean
670744|NCT01696071|Primary|Forced Expiratory Volume in One Second (FEV1) Area Under the Curve From 0 - 24h (AUC 0-24) Response.|"Mixed Model Repeated Measure (MMRM) results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline.Measured following the respective dosing determined at the end of each 4 week period of randomised treatment. AUC0-24h calculated using the trapezoidal rule divided by the observation time (24 hours) to report in litres.
The values recorded at 11 hours 50 minutes and at 23 hours 50 minutes post dosing were assigned to 12 and 24 hours, respectively."|Baseline FEV1 taken at visit 2 prior to the first evening dose of randomised study medication. Then, 10 minutes (min) prior to dose to 30 min,1 hour (h),2h,3h,4h,11h50min,12h30min,13h,14h,15h,16h,18h,20h,22h and 23h,23h50min relative to dose after 4 weeks|Full Analysis Set (FAS): The full analysis set (FAS) includes all patients in the treated set who had baseline data and at least one on-treatment efficacy value after 4 weeks on treatment within a period.||Liters||Standard Error|Least Squares Mean
670837|NCT01694420|Other Pre-specified|Number of Participants With Grade 3 or Grade 4 Adverse Events||48 weeks|||participants|||Number
670745|NCT01696058|Secondary|Rescue Medication Usage - Mean Weekly Rescue Usage (Nighttime)|"Rescue medication usage - Mean weekly rescue usage during nighttime hours. Administration of rescue medication could occur at any point during the trial as deemed necessary by the patient or the investigator. Open label albuterol MDI (100 μg per puff) was provided as rescue medication by BI, and only the albuterol MDI provided by BI was allowed for rescue medication use. Daily, between clinic visits, patients recorded the number of puffs of albuterol in a paper diary.
Results are from non−MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.
Number of patients contributing to models: Tio+Placebo (559), Tio+Olo 5ug (555)"|over 12 weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation||number of puffs||Standard Error|Least Squares Mean
670746|NCT01696058|Secondary|Rescue Medication Usage - Mean Weekly Rescue Usage (Daytime)|"Rescue medication usage - Mean weekly rescue usage during daytime hours. Administration of rescue medication could occur at any point during the trial as deemed necessary by the patient or the investigator. Open label albuterol MDI (100 μg per puff) was provided as rescue medication by BI, and only the albuterol MDI provided by BI was allowed for rescue medication use. Daily, between clinic visits, patients recorded the number of puffs of albuterol in a paper diary.
Results are from non−MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.
Number of patients contributing to models: Tio+Placebo (559), Tio+Olo 5ug (555)"|over 12 weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation||number of puffs||Standard Error|Least Squares Mean
670747|NCT01696058|Secondary|Rescue Medication Usage - Mean Weekly Rescue Usage (Total Daily)|"Rescue medication usage - mean weekly rescue usage (total daily). The baseline for the rescue use was the mean of the observations during the last week of the baseline period. Administration of rescue medication could occur at any point during the trial as deemed necessary by the patient or the investigator. Open label albuterol metered dose inhaler (MDI) (100 μg per puff) was provided as rescue medication . Daily, between clinic visits, patients recorded the number of puffs of albuterol in a paper diary.
Results are from non−MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.
Number of patients contributing to models: Tio+Placebo (559), Tio+Olo 5ug (555)"|over 12 weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation||usage (total daily) number of puffs||Standard Error|Least Squares Mean
670748|NCT01696058|Secondary|Rescue Medication Usage - Percentage of Rescue Free Days|"Rescue medication usage - the percentage of rescue free days. The percentage of rescue free days is defined as: number of rescue free days divided by total exposure, multiplied by 100%. The baseline for the number of rescue-free days was defined as the number of rescue-free days observed during the last week of the baseline period (i.e., the 7 days prior to administration of the first dose of randomized treatment).
Results are from non−MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.
Number of patients contributing to models: Tio+Placebo (559), Tio+Olo 5ug (552)"|over 12 weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation||percentage of days||Standard Error|Least Squares Mean
670749|NCT01696058|Secondary|Trough FVC Response at 12 Weeks; Defined as Change From Baseline|Trough Forced Vital Capacity (FVC) response at 12 weeks- defined as change from baseline.|baseline and 12 weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation||L||Standard Error|Least Squares Mean
670750|NCT01696058|Secondary|Peak FVC Response at 12 Weeks; Defined as Change From Baseline|Peak FVC response at 12 weeks - defined as change from baseline.|baseline and 12 weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation at 12 weeks.||L||Standard Error|Least Squares Mean
670751|NCT01696058|Secondary|FVC AUC0-3h Response at 12 Weeks; Defined as Change From Baseline|Forced Vital Capacity (FVC) AUC0-3h response at 12 weeks - defined as change from baseline. AUC was standardized by dividing by time unit.|baseline and 12 Weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation at 12 weeks.||L||Standard Error|Least Squares Mean
670752|NCT01696058|Secondary|Peak FEV1 Response at 12 Weeks - Defined as Change From Baseline|Peak FEV1 (Forced Expiratory Volume in 1 second) response at 12 Weeks - defined as change from baseline. All p-values for these measures are only descriptive.|baseline and 12 weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation at 12 weeks.||L||Standard Error|Least Squares Mean
670753|NCT01696058|Secondary|Saint George Respiratory Questionnaire - (Total Score) Based on Combined 1222.51 and 1222.52 Data|The Saint George Respiratory Questionnaire (SGRQ) is designed to measure health impairment in patients with asthma and chronic obstructive pulmonary disease (COPD). It is divided into two parts. Part I produces the Symptoms score (several scales), and Part II the Activity and Impacts scores [dichotomous (true/false) except last question (4-point Likert scale)]. A Total score is also produced with scores ranging from 0 to 100, with higher scores indicating more limitations. Since the SGRQ analysis is based on the combined data from both this study and protocol 1222.51 (NCT01694771), only combined SGRQ results will be included in the latest clinical trial report. Hence there will only be one SGRQ analysis from both studies, which will not appear in the first clinical trial report. For this same reason, another covariate – study – will also be included in the MMRM for SGRQ analysis. The combined data for this outcome measure was pre-specified in both protocols.|12 weeks|FAS with last observation carried forward (LOCF) imputation (combined data from twin studies 1222.51 and 1222.52). Number of patients contributing to models: Tio+Placebo (1055), Tio+Olo 5ug (1039).||units on a scale (total score)||Standard Error|Least Squares Mean
670754|NCT01696058|Primary|Trough FEV1 Response at 12 Weeks; Defined as Change From Baseline to Week 12|Trough FEV1 (Forced expiratory volume in 1 second) response at 12 weeks; defined as change from baseline to Week 12|baseline and 12 weeks|Full Analysis set (FAS) with last observation carried forward (LOCF) imputation at 12 weeks.||L||Standard Error|Least Squares Mean
670755|NCT01696058|Primary|FEV1 AUC0-3h Response at 12 Weeks; Defined as Change From Baseline to Week 12|FEV1 (Forced expiratory volume in 1 second) AUC0-3h (area under the curve) response at 12 weeks; defined as change from baseline to Week 12. AUC was standardized by dividing by time unit.|baseline and 12 weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation at 12 weeks. FAS included all patients in the treated set who had both baseline and at least one post-baseline measurement at or before 12 weeks for any of the co-primary efficacy variables||Area Under the Curve (L) (standardized)||Standard Error|Least Squares Mean
670838|NCT01694420|Secondary|Rate of Virologic Decline in the First 48 Weeks of Treatment Comparing FDC ELV/COBI/FTC/TDF to FDC EFV/FTC/TDF||48 weeks|||days||Full Range|Median
670756|NCT01696045|Secondary|Overall Survival Time|Overall Survival time was defined as the time from the start of ipilimumab treatment date to date of death due to any cause. Participants who had not died were censored at the time of last contact (last known alive date).|From date of first treatment to date of death (Assessed up to June 2016, approximately 38 months)|All treated participants||months||95% Confidence Interval|Median
670757|NCT01696045|Secondary|Best Overall Response Rate (BORR)|"Best Overall Response Rate (BORR) was defined as the total number of participants with the best overall response of Complete Response (CR) or Partial Response (PR) divided by the total number of treated participants and expressed as a percentage.
CR= Complete disappearance of all non-index lesions. PR= Decrease, relative to baseline, of 50% or greater in the sum of the products of the two largest perpendicular diameters of all index lesions. SD= Does not meet criteria for complete or partial response, in the absence of progressive disease. PD= At least 25% increase in the sum of the products of all index lesions (taking as reference the smallest sum recorded at or following baseline) and/or the appearance of any new lesion(s)."|From Day 1 of first subject, first treatment to Day 365 of last subject, first treatment (approximately 36 months)|All treated participants||percentage of participants||95% Confidence Interval|Number
670758|NCT01696045|Secondary|Progression Free Survival|Progression-Free Survival was defined as the time from the start of ipilimumab treatment to disease progression or death, whichever occurs first. A participant who died without reported progression was considered to have progressed on their date of death. For participants who remained alive and had not progressed, PFS was censored on the date of the last tumor assessment.|From date of first treatment until disease progression or death (Assessed up to June 2016, approximately 38 months)|All treated participants||months||95% Confidence Interval|Median
670759|NCT01696045|Secondary|Disease Control Rate (DCR)|"Disease control rate was defined as the percentage of all treated participants with a best overall response of Complete Response (CR), Partial Response (PR), or Stable disease (SD), based on the investigator's assessment per mWHO Criteria.
CR= Complete disappearance of all non-index lesions. PR= Decrease, relative to baseline, of 50% or greater in the sum of the products of the two largest perpendicular diameters of all index lesions. SD= Does not meet criteria for complete or partial response, in the absence of progressive disease. PD= At least 25% increase in the sum of the products of all index lesions (taking as reference the smallest sum recorded at or following baseline) and/or the appearance of any new lesion(s)."|From Day 1 of first subject, first treatment to Day 365 of last subject, first treatment (approximately 36 months)|All treated participants||Percentage of participants||95% Confidence Interval|Number
670760|NCT01696045|Primary|Percentage of Participants With Severe Immune-Mediated Adverse Reactions (imARs)|The percentage of participants with severe Immune-mediated Adverse Reactions (imARs) was determined by dividing the number of participants with grade 3 or worse imARs by the total number of treated participants and expressing this number as a percentage. imARs were AEs determined by the investigator to have an immune-mediated etiology, including inflammatory events associated with ipilimumab treatment.|From first dose to 90 days after last dose (Assessed up to June 2016, approximately 38 months)|All treated participants||percentage of participants||95% Confidence Interval|Number
670761|NCT01696045|Primary|Overall Survival (OS) Rate at 1 Year|Overall Survival (OS) was defined as the time from the start of ipilimumab treatment date to death due to any cause. If a participant had not died, the participant was censored at the time of last contact (last known alive date). OS rates at 1 year were calculated from both Kaplan-Meier estimates and the proportion of participants alive at 1 year following start of treatment.|1 year following start of treatment (Assessed up to June 2016, approximately 38 months)|All treated participants||percentage of participants||95% Confidence Interval|Number
670762|NCT01695772|Secondary|Percent Probability Of Being Alive and Disease Free at Months 3, 6, 9, and 12||Months 3, 6, 9, and 12|ITT population||PP of being alive and disease free||95% Confidence Interval|Median
670763|NCT01695772|Secondary|Disease Free Survival (DFS)|Disease Free Survival (DFS) was defined as the time from complete resection of liver metastases to disease relapse or death, for participants who achieve complete resection after pre-operative treatment with standard 5-FU based doublet regimen plus bevacizumab.|Complete resection date up to disease relapse or death until data cutoff on 12 May 2016 (up to approximately 3.5 years)|ITT population; Here, number of participants analyzed = participants who underwent study specified surgery. Participants who underwent surgery but did not achieve complete resection were censored.||months||95% Confidence Interval|Median
670764|NCT01695772|Secondary|Number of Participants With Disease Relapse or Death||Screening until disease progression or death until data cutoff on 12 May 2016 (up to approximately 3.5 years overall)|ITT population||participants|||Number
670765|NCT01695772|Secondary|Percent Probability (PP) of Being Alive and Progression Free at Months 3, 6, 9, 12, 15, and 18|Progressive Disease is defined as a 20% or greater increase in the sum of the longest diameter of measured lesions (target lesions) taking as reference the smallest lesion diameter recorded since the treatment started or appearance of one or more new non-target lesions. PFS was defined as the time from initiation of study treatment to disease progression, as determined by the investigator using RECIST v1.1 criterion, or relapse after resection of liver metastases or death from any cause. The probability was estimated by Kaplan Meier curve analysis.|Months 3, 6, 9, 12, 15, and 18|ITT population; Number of participants analyzed equals (=) number of participants who had surgery.||PP of being alive and progression free||95% Confidence Interval|Number
670766|NCT01695772|Secondary|Progression Free Survival (PFS)|Progressive Disease is defined as a 20% or greater increase in the sum of the longest diameter of measured lesions (target lesions) taking as reference the smallest lesion diameter recorded since the treatment started or appearance of one or more new non-target lesions. PFS was defined as the time from initiation of study treatment to disease progression, as determined by the investigator using RECIST v1.1 criterion, or relapse after resection of liver metastases or death from any cause. Kaplan-Meier curves were used to display PFS.|Screening until disease progression or death until data cutoff on 12 May 2016 (up to approximately 3.5 years overall)|ITT population||months||95% Confidence Interval|Median
670767|NCT01695772|Secondary|Number of Participants With Disease Progression or Relapse or Death|According to RECIST v1.1 Progressive Disease is defined as a 20 % or greater increase in the sum of the longest diameter of measured lesions (target lesions) taking as reference the smallest lesion diameter recorded since the treatment started or appearance of one or more new non-target lesions.|Screening until disease progression or death until data cutoff on 12 May 2016 (up to approximately 3.5 years overall)|ITT population||participants|||Number
670768|NCT01695772|Secondary|Percentage of Participants Achieving Objective Response|Objective response rate was defined as the percentage of participants who achieved either Partial Response (PR) or Complete Response (CR) per Response Evaluation Criteria In Solid Tumors (RECIST) version (v) 1.1. This is defined as the best response recorded from the start of trial treatment until disease progression (or death). CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than [<] 10 mm). No new lesions. PR was defined as greater than or equal to [≥] 30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.|Screening until disease progression or death until data cutoff on 12 May 2016 (up to approximately 3.5 years overall)|ITT population||percentage of participants||95% Confidence Interval|Number
670769|NCT01695772|Secondary|Percentage of Participants Achieving Incomplete Tumor Resection (R1 Resection)|R1 resection was defined as achievement of incomplete tumor resection with microscopic involvement of a margin after pre-operative chemotherapy plus bevacizumab, as confirmed by pathology. Participants with R1 resections based on assessments performed at time of surgery, 48 hours post-surgery and 4 and 12 weeks after surgery were reported.|At time of surgery (up to 28 weeks), 48 hours post-surgery and 4 and 12 weeks after surgery (up to 40 weeks)|ITT population||percentage of participants||95% Confidence Interval|Number
670770|NCT01695772|Primary|Percentage of Participants Achieving Complete Resection (R0 Resection)|R0 resection was defined as complete resection confirmed by pathology after pre-operative chemotherapy plus bevacizumab. Participants with R0 resections based on assessments performed at time of surgery, 48 hours post-surgery and 4 and 12 weeks after surgery were reported.|At time of surgery (up to 28 weeks), 48 hours post-surgery and 4 and 12 weeks after surgery (up to 40 weeks)|ITT population||percentage of participants||95% Confidence Interval|Number
670771|NCT01695746|Secondary|Number of Participants With Adverse Events and Serious Adverse Events|An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Pre-existing conditions which worsened during this study were reported as AEs. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.|Up to Week 24|The safety population was defined as all participants entered into the study.||Participants|||Number
670772|NCT01695746|Secondary|Number of Participants Who Received Concomitant Treatment for Anemia|Medications that were used during the study treatment period (from the date of first dose of study medication to the end of the study) were included as concomitant medications. The number of participants taking concomitant medications prescribed for the treatment of anemia (for example iron) is presented.|Up to Week 24|The safety population included all participants entered into the study.||Participants|||Number
670773|NCT01695746|Primary|Percentage of Participants Maintaining Hemoglobin Level Within 1 Gram/Deciliter of Baseline Value|Maintenance of Hb levels was to be evaluated for participants on Erythropoiesis stimulating agent (ESA) with Hb levels 10-12 g/dL. None of the participants in the enrolled population had received treatment with other ESAs and had pre-therapy Hb level as 10 g/dL or above. Therefore, the percentage of participants who had received treatment with other ESAs and were maintaining Hb level within 1 g/dL of baseline value during the study could not be evaluated. Baseline is defined as Week 0.|Up to Week 24|The ITT population was the anticipated population for analysis.|||||
670774|NCT01695746|Primary|Mean Time to Achieve Target Hemoglobin Range (10-12 Gram/Deciliter)|Correction of anemia was evaluated in participants with Hb < 10 gram/deciliter (g/dL). Hemoglobin levels were recorded for each participant at enrollment and at different time points during the study up to Week 24. The mean time required to achieve target Hb range (10-12 g/dL) was calculated using the following formula: Time to achieve target range = (Date of Hb evaluation when participant achieves target range at first time – visit date of first dosing) + 1.|Up to Week 24|The intent-to-treat (ITT) population included all participants who received at least 1 dose of C.E.R.A. (Week 0), for whom data for at least one follow-up variable was available, and who did not have a major protocol violation. The participants who achieved target Hb range (10-12 g/dL) were included in the analysis.||Weeks||Standard Deviation|Mean
670775|NCT01695746|Primary|Number of Participants With Co-morbidities at Baseline (Week 0)|Co-morbidities were those medical disorders present in the medical history but unresolved at Baseline. The number of participants with different co-morbidities is presented. Baseline is defined as Week 0.|At Baseline (Week 0)|The safety population included all participants entered into the study.||Participants|||Number
670776|NCT01695746|Secondary|Number of Doses of C.E.R.A. Administered by Different Routes|The number of doses of C.E.R.A. administered by the intravenous or subcutaneous route is presented. The number of doses for total population is calculated by summation and presented in table below as per routes of administration.|Up to Week 24|The safety population included all participants entered into the study.||Doses|||Number
670777|NCT01695746|Secondary|Mean Dose of C.E.R.A. Administered|The mean dose of C.E.R.A. administered during the study is reported. This accounts for the study drug injected through subcutaneous route at a frequency of every 4 weeks or once a month and every 2 weeks or fortnightly.|Up to Week 24|The safety population included all participants entered into the study.||mcg per month||Standard Deviation|Mean
670778|NCT01695746|Secondary|Mean Time Spent in the Hemoglobin Target Range (10 – 12 Gram/Deciliter)|The Hb concentration was recorded for all the participants at enrollment and different time points throughout the study up to Week 24. The mean time spent (in weeks) by the participants in the target range (10 – 12 g/dL) is presented.|Up to Week 24|The ITT population included all participants who received at least 1 dose of C.E.R.A. (Week 0), for whom data for at least one follow-up variable was available, and who did not have a major protocol violation. The participants who achieved target Hb range (10-12 g/dL) were included in the analysis.||Weeks||Standard Deviation|Mean
670839|NCT01694420|Secondary|Immune Activation as Measured by the Proportion of CD4+ and CD8+ Cells Expressing HLA-DR and CD38+||48 weeks|Data not collected|||||
670779|NCT01695746|Secondary|Percentage of Participants Achieving Hemoglobin Target Range (10-12 Gram/Deciliter) at Least Once During the Study|Correction of anemia was evaluated in participants with Hb < 10 g/dL at enrollment. Hemoglobin levels were recorded for each participant at enrollment and at different time points during the study up to Week 24. The percentage of participants achieving the target Hb range (10-12 g/dL) at least once during the study is presented.|Up to Week 24|The ITT population included all participants who received at least 1 dose of C.E.R.A. (Week 0), for whom data for at least one follow-up variable was available, and who did not have a major protocol violation.||Percentage of participants|||Number
670780|NCT01695746|Primary|Mean Weight of Participants at Baseline (Week 0)|The mean body weight of the participants was measured and summarized in kg. Baseline is defined as Week 0.|At Baseline (Week 0)|The safety population included all participants entered into the study.||kg||Standard Deviation|Mean
670781|NCT01695746|Primary|Mean Height of Participants at Baseline (Week 0)|The mean body height of the participants was measured and summarized in centimeters (cm). Baseline is defined as Week 0.|At Baseline (Week 0)|The safety population included all participants entered into the study.||cm||Standard Deviation|Mean
670782|NCT01695668|Primary|Progression of Dry Eye Severity|Dry eye is one of the major symptoms of ocular GVHD in bone-marrow transplant recipients, worsening of dry eye symptoms may be indicative of worsening ocular GVHD conditions.|1 year|||patients with increased dry eye severity|||Number
670783|NCT01695369|Primary|Subjective Responses for Comfort Rated on a 0-100 Visual Scale.|Subjective Patient Ratings measured using a Visual Analog Scale on a 0-100. (0=Cannot be worn. Causes pain, 20=Frequently irritating, 40=Occasionally irritating, 60=Occasionally noticeable but not irritating, 80=Rarely noticeable, 100=Cannot be felt ever)|Baseline Insertion, 10 Minutes, 5 hours and 10 hours|||units on a scale||Standard Deviation|Mean
670784|NCT01695330|Secondary|Compare Overall Response Rate (CR + VGPR + PR + MR), Compare Disease Parameters, & Determine Incidence and Severity of Injection-site Reactions.|Compare overall response rate [combined CR + very good partial response (VGPR) + PR + MR] and disease parameters [time to progression, -progression free survival, -time to first response, -duration of response, -overall survival] following treatment with a SC bortezomib-containing combination regimen for MM patients who have demonstrated progressive disease form a prior or different IV bortezomib-containing combination regimen. Determine incidence and severity of injection-site reactions with CS administration of bortezomib by number of patients with injection site reaction specific adverse events.|Subjects eligible for this study will receive treatment with study drug for a maximum of eight 28 day treatment cycles.||10/2017||||
670785|NCT01695330|Primary|The Primary Objective of This Study Will be to Investigate the Incidence and Severity of Peripheral Neuropathy Caused by a Prior Intravenous VELCADE-containing Regimen in Comparison to That Caused by a Subcutaneous VELCADE-containing Regimen.|"Definition of incidence: the number of participants enrolled in the study experiencing treatment-emergent peripheral neuropathy. Emergence of peripheral neuropathy is determined via neurological assessment conducted on Day 1 and Day 11 of each treatment cycle as well as during the End of Study visit.
Definition of severity: the severity of any treatment-emergent peripheral neuropathy experienced by a patient on-study. Peripheral neuropathy severity is determined via neurological assessment conducted on Day 1 and Day 11 of each treatment cycle as well as the End of Study visit and is graded on a 0-4 scale based on CTCAE criteria.
Incidence of Peripheral Neuropathy Definition: the number of participants enrolled in the study experiencing treatment-emergent peripheral neuropathy. Emergence of peripheral neuropathy is determined via neurological assessment conducted on Day 1 and Day 11 of each treatment cycle as well as during the End of Study visit."|Subjects eligible for this study will receive treatment with study drug for a maximum of eight 28 day treatment cycles.|||Participants|||Count of Participants
670786|NCT01695304|Primary|Health Facility Visits for Diarrheal Disease|incidence rate of health facility visits for diarrheal disease per 100 person-week of observation|6 months|incidence rate of health facility visits for diarrheal disease per 100 person-week of observation||incidence rate per 100 person-weeks|||Number
670787|NCT01695304|Primary|Longitudinal Diarrhea Prevalence|The primary outcome measure is the longitudinal prevalence of diarrheal disease.|6 months|Incidence rate per 100 person-weeks of observation||Incidence rate per 100 person-weeks|||Number
670809|NCT01695044|Primary|Overall Radiologic Response|Overall radiologic response was measured prior to the first dose of study drug, at predose of cycle 5, and at the end of study. Imaging techniques used at screening were used throughout the study. The preferred imaging techniques include: bone scan, contrast enhanced CT of chest, contrast enhanced CT of pelvis, and contrast enhanced CT of upper & lower abdomen. Best overall radiologic response (confirmed), target and non-target lesions, was defined as responses in bone, visceral or nodal metastases according to the Modified Response Evaluation Criteria (RECIST 1.1). The best overall radiologic response is the best response recorded from the start of the treatment until disease progression/recurrence (taking, as reference for progressive disease, the smallest measurements recorded since the treatment started). The subject’s best response assignment depended on the achievement of both measurement and confirmation criteria.|24 weeks|Both groups must also have received and progressed on abiraterone acetate and/or enzalutamide prior to the study (once these agents were commercially available for use). The full modified Intention-to-Treat (mITT) population (n = 119) was examined.||% of subjects|||Number
670810|NCT01695044|Primary|CTC Response|Circulating tumor cells (CTC) response was examined at two levels: at least 30% decrease or at least 50% decrease in CTC levels. Response was defined as any decrease from baseline of at least 30% or 50%.|24 Weeks|Both groups must also have received and progressed on abiraterone acetate and/or enzalutamide prior to the study (once these agents were commercially available for use). The population examined was those subjects with a CTC baseline value and at least one post-baseline value.||% of responders|||Number
670811|NCT01695044|Primary|Percentage of Participants With Total Serum PSA Response|Total serum prostate-specific antigen (PSA) response was defined as any decrease from baseline of at least 30% or 50%.|24 Weeks|Both groups must also have received and progressed on abiraterone acetate and/or enzalutamide prior to the study (once these agents were commercially available for use). The population examined was those subjects with a PSA baseline value and at least one post-baseline value.||% of responders|||Number
670812|NCT01694771|Secondary|Rescue Medication Usage - Mean Weekly Rescue Usage (Nighttime)|Rescue medication usage - Mean weekly rescue usage during nighttime hours. Administration of rescue medication could occur at any point during the trial as deemed necessary by the patient or the investigator. Open label albuterol MDI (100 μg per puff) was provided as rescue medication by BI, and only the albuterol MDI provided by BI was allowed for rescue medication use. Daily, between clinic visits, patients recorded the number of puffs of albuterol in a paper diary.|over 12 weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation||percentage of days||Standard Error|Least Squares Mean
670813|NCT01694771|Secondary|Rescue Medication Usage - Mean Weekly Rescue Usage (Daytime)|Rescue medication usage - Mean weekly rescue usage during daytime hours. Administration of rescue medication could occur at any point during the trial as deemed necessary by the patient or the investigator. Open label albuterol MDI (100 μg per puff) was provided as rescue medication by BI, and only the albuterol MDI provided by BI was allowed for rescue medication use. Daily, between clinic visits, patients recorded the number of puffs of albuterol in a paper diary.|over 12 weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation||percentage of days||Standard Error|Least Squares Mean
670814|NCT01694771|Secondary|Rescue Medication Usage - Mean Weekly Rescue Usage (Total Daily)|Rescue medication usage - mean weekly rescue usage (total daily). The baseline for the rescue use was the mean of the observations during the last week of the baseline period. Administration of rescue medication could occur at any point during the trial as deemed necessary by the patient or the investigator. Open label albuterol MDI (100 μg per puff) was provided as rescue medication . Daily, between clinic visits, patients recorded the number of puffs of albuterol in a paper diary.|over 12 weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation||usage (total daily) number of puffs||Standard Error|Least Squares Mean
670815|NCT01694771|Secondary|Rescue Medication Usage - Percentage of Rescue Free Days|Rescue medication usage - the percentage of rescue free days. The percentage of rescue free days is defined as: number of rescue free days divided by total exposure, multiplied by 100%. The baseline for the number of rescue-free days was defined as the number of rescue-free days observed during the last week of the baseline period (i.e., the 7 days prior to administration of the first dose of randomized treatment).|over 12 weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation||percentage of days||Standard Error|Least Squares Mean
670816|NCT01694771|Secondary|Peak FVC Response at 12 Weeks - Defined as Change From Baseline|Peak FVC response at 12 weeks - defined as change from baseline.|baseline and 12 weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation at 12 weeks.||L||Standard Error|Least Squares Mean
670817|NCT01694771|Secondary|Trough FVC Response at 12 Weeks- Defined as Change From Baseline|Trough Forced Vital Capacity (FVC) response at 12 weeks- defined as change from baseline.|baseline and 12 weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation||L||Standard Error|Least Squares Mean
670821|NCT01694771|Primary|FEV1 AUC0-3h Response at 12 Weeks; Defined as Change From Baseline to Week 12|FEV1 (Forced expiratory volume in 1 second) AUC0-3h (area under the curve) response at 12 weeks; defined as change from baseline to Week 12|baseline and 12 weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation at 12 weeks. FAS included all patients in the treated set who had both baseline and at least one post-baseline measurement at or before 12 weeks for any of the co-primary efficacy variables||Area Under the Curve (L)||Standard Error|Least Squares Mean
670822|NCT01694706|Secondary|Faldaprevir: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)|"Area under the concentration-time curve of the faldaprevir in plasma over the time interval from 0 to the last quantifiable drug plasma concentration
In this endpoint, the measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h and 120h after drug administration|PK set||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
670823|NCT01694706|Primary|Faldaprevir: Maximum Measured Concentration (Cmax)|"Maximum measured concentration of the faldaprevir in plasma
In this endpoint, the measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h and 120h after drug administration|PK set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
670824|NCT01694706|Primary|Faldaprevir: Area Under the Curve Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity)|"Area under the concentration-time curve of the faldaprevir in plasma over the time interval from 0 extrapolated to infinity
In this endpoint, the measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h and 120h after drug administration|Pharmacokinetic (PK) set: Included all treated subjects that provided at least 1 observation for at least 1 primary endpoint without important protocol violations with respect to the statistical evaluation of the pharmacokinetic endpoints.||[ng*h/mL]||Geometric Coefficient of Variation|Geometric Mean
670825|NCT01694667|Secondary|Change in Clinical Global Impression - Improvement (CGI-I) Score|"Measures the clinical impression of improvement on a 7-point Likert scale (ranging from 1 - very much improved - to 7 - very much worse) is a commonly used measure of overall improvement in intervention studies of children with ASD. This tool will be completed by the parent and caregiver, and is therefore considered a modified version of the instrument, which is normally completed by a clinician. This is considered an exploratory analysis of this outcome tool since it is being used in a non-standard fashion. The number of participants who responded in each group is the number where the parents reported that their child was improved, much improved, or very much improved."|Baseline, Week 6|||# parents reporting improvement|||Number
670826|NCT01694667|Secondary|Change in Social Responsiveness Scale (SRS) Score|Social interaction will be assessed with the SRS. This scale examines the presence and extent of autistic social impairment and is administered by parents or teachers of children with ASD. Higher scores are indicative of greater severity. Normative data have been derived from a sample of over 1,600 children.|Baseline, Week 6||||||
670827|NCT01694667|Secondary|Aberrant Behavior Checklist - Inappropriate Speech Subscale Score|"The Aberrant Behavior Checklist (ABC) is a 58-item survey. Items are rated on a 4-point scale from 0=no problem to 3=major problem. Higher scores indicate greater severity. Scores can be computed for five subscales: hyperactivity, lethargy, stereotypical behavior, irritability, and inappropriate speech. The inappropriate speech subscale is comprised of 4 items. The outcome measure is the change from baseline to six weeks in the scale. Total score ranges from 0 to 12."|Baseline, Week 6|||units on a scale||Standard Deviation|Mean
670828|NCT01694667|Secondary|Aberrant Behavior Checklist - Irritability Subscale Score|"The Aberrant Behavior Checklist (ABC) is a 58-item survey. Items are rated on a 4-point scale from 0=no problem to 3=major problem. Higher scores indicate greater severity. Scores can be computed for five subscales: hyperactivity, lethargy, stereotypical behavior, irritability, and inappropriate speech. The irritability subscale is comprised of 15 items. The outcome measure is the change from baseline to six weeks in the scale. Total score ranges from 0 to 45."|Baseline, Week 6|||units on a scale||Standard Deviation|Mean
670829|NCT01694667|Secondary|Change in Aberrant Behavior Checklist - Stereotypy Subscale Score|"The Aberrant Behavior Checklist (ABC) is a 58-item survey. Items are rated on a 4-point scale from 0=no problem to 3=major problem. Higher scores indicate greater severity. Scores can be computed for five subscales: hyperactivity, lethargy, stereotypical behavior, irritability, and inappropriate speech. The stereotypy subscale is comprised of 7 items. The outcome measure is the change from baseline to six weeks in the scale. Total score ranges from 0 to 21."|Baseline, Week 6|||units on a scale||Standard Deviation|Mean
670830|NCT01694667|Secondary|Change in Aberrant Behavior Checklist - Lethargy Subscale Score|"The Aberrant Behavior Checklist (ABC) is a 58-item survey. Items are rated on a 4-point scale from 0=no problem to 3=major problem. Higher scores indicate greater severity. Scores can be computed for five subscales: hyperactivity, lethargy, stereotypical behavior, irritability, and inappropriate speech. The lethargy subscale is comprised of 16 items. The outcome measure is the change from baseline to six weeks in the scale. Total score ranges from 0 to 48."|Baseline, Week 6|||units on a scale||Standard Deviation|Mean
670831|NCT01694667|Primary|Change in Aberrant Behavior Checklist - Hyperactivity Subscale (ABC-H) Score|"The Aberrant Behavior Checklist (ABC) is a 58-item survey. Items are rated on a 4-point scale from 0=no problem to 3=major problem. Higher scores indicate greater severity. Scores can be computed for five subscales: hyperactivity, lethargy, stereotypical behavior, irritability, and inappropriate speech. The hyperactivity subscale is comprised of 16 items. The outcome measure is the change from baseline to 6 weeks. The total score ranges from 0 to 48."|Baseline, 6 weeks (3 week value to be collected)|||units on a scale||Standard Deviation|Mean
670832|NCT01694641|Other Pre-specified|Perinatal Outcome|gestational age at delivery, birth weight,|perinatal outcome assessed after delivery||||||
670833|NCT01694641|Other Pre-specified|Time Lapse Score|a score based on 8 observations by time lapse monitoring|the time lapse score is assessed on the day of embryo transfer (day 5 after the egg retrieval)||||||
670834|NCT01694641|Secondary|Clinical Pregnancy|intrauterine sac plus embryo with heartbeat at 8 weeks gestation|at 8 weeks gestation||||||
670842|NCT01694199|Secondary|Time to First Use of Supplemental Analgesic Medication|The time to first supplemental analgesic use was recorded. This was defined as the time from the initiation of the first study device treatment session (T0) to the time of administration of the first dose of post-T0 supplemental medication.|Treatment with the test device twice per day, over 3 days (7 total treatments)|||Minutes||95% Confidence Interval|Median
670843|NCT01694199|Secondary|Number of Participants Who Assessed Pain Control at 72 Hours as Good, Very Good, or Excellent|Number of participants who assessed pain control at 72 hours as good, very good, or excellent.|After 3 days of treatment (T0-72 hours)|||Participants|||Count of Participants
670844|NCT01694199|Secondary|Opioid Consumption Measured in Morphine Equivalents T0-72 Hours|The total quantity of Supplemental Opioid analgesic administered throughout the study was recorded for each Subject. Opioid consumption prior to (T0) was not considered when calculating opioid consumption endpoints.|Treatment with the test device twice per day, over 3 days (7 total treatments)|||Morphine Equivalents||95% Confidence Interval|Median
670845|NCT01694199|Secondary|TOTPAR-Pain Relief Experienced by Patients T0-72 Hours|"Pain relief was assessed at completion of first study device treatment, 45 minutes, 60 minutes, 90 minutes, 2 hours, 3 hours, 4 hours, 6 hours following T0 (±5 mins). Thereafter, pain relief was assessed every 2 hours (±5 mins) between 6AM to 10PM throughout the in-patient treatment period. After 10 PM and before 6AM, pain relief assessments were done every 4 hours. Subjects rated pain relief relative to baseline pain intensity using a categorical scale: 0=none; 1=a little; 2=some; 3= a lot; 4 = complete. Based on these scores, a time weighted pain relief score was calculated, Total Pain Relief (TOTPAR). TOTPAR-Pain Relief = ∑PID x (time(t) - time(t-1)) x PID(i)."|Treatment with the test device twice per day, over 3 days (7 total treatments)|||units on a scale||95% Confidence Interval|Geometric Mean
670846|NCT01694199|Primary|Overall Analgesic Efficacy (Via SPID 0-72 Hrs)|Sum of time-weighted Pain Intensity Differences (SPID). Pain relief was assessed at completion of first treatment, 45min,60min,90min,2hrs,3hrs,4hrs,6hrs following T0 and every 2hrs between 6AM to 10PM. After 10 PM and before 6AM, pain relief assessments were done every 4hrs. Subjects rated pain relief relative to baseline using a categorical scale: 0=none; 1=a little; 2=some; 3= a lot; 4 = complete. SPIDt = ∑PID x (time(t) - time(t-1)) x PID(i). A more negative SPID value means less pain. Total score of SPID ranged from a min value of -1091550.00 in the active arm and -2120130.00 in the sham arm and a max value of 603060.00 in the active arm and 1077630.00 in the sham arm. No absolute min and max scores were calculated.|Treatment with the test device twice per day, over 3 days (7 total treatments)|P=0.3529||units on a scale||95% Confidence Interval|Median
670847|NCT01694108|Other Pre-specified|Quality of Communication and Information|"To test that the use of telephone and internet was acceptable in the study population using the Quality of Informed Consent (QuIC) questionnaire. The questionnaire was divided into six categories; five on study comprehension and one on satisfaction with the information process. The items in the first five categories could be answered with yes, no or do not know. The last category was rated on a 7-point Likert scale, with 1 being “very dissatisfied” and 7 being “very satisfied”. The primary outcome was the sum of the score for comprehension items and satisfaction items. Comprehension items were scored 1 point for each correct answer and 0 points for each incorrect answer. Satisfaction items were scored as rated on the 7-point Likert scale. Total score ranged from 7 to 69 points, comprehension score from 0 to 20 points and satisfaction score from 7 to 49 points. The higher score, the better comprehension and satisfaction."|2 days after the information was given|This is a small, separate sub-study. 59 + 59 participants had sufficient follow-up data to participate in the analysis.||Score on QuIC scale||Inter-Quartile Range|Mean
670848|NCT01694108|Other Pre-specified|Decisional Conflict Scale Score|After parents having made the decision about whether to accept vaccination of their newborn through participation in The Danish Calmette Study, O’Connor’s Decisional Conflict Scale was used to identify decisional conflicts. The score ranges from 0 (no decisional conflict) til 100 (maximum decisional conflict). Scores lower than 25 are associated with implementing decisions; scores exceeding 37.5 are associated with decision delay or feeling unsure about implementation; so a low score reflects a low level of doubt about the decision about participation/decline participation in the trial, and a high score reflects a high level of doubt.|The decisional conflict score was measured before randomisation|This outcome was a sub-study to The Danish Calmette Study with 667 participating mothers and 320 declining mothers.||decisional conflict score||Inter-Quartile Range|Mean
670849|NCT01694108|Secondary|Number of Events of Febrile Convulsions|To test that Danish infants who get the BCG vaccine at birth develop less febrile convulsions at 13 months of age than non-BCG-immunised infants.|13 months of age|This analysis only includes children with available follow-up data. As opposed to the primary outcome, follow-up for this outcome was lower than 100%.||Events|||Number
670850|NCT01694108|Secondary|Number of Events of Acute Otitis Media|To test that Danish infants who get the BCG vaccine at birth develop less acute otitis media at 13 months of age than non-BCG-immunised infants.|13 months of age|This analysis only includes children with available follow-up data. As opposed to the primary outcome, follow-up for this outcome was lower than 100%.||Events|||Number
670851|NCT01694108|Secondary|Number of Events With Diarrhoea and Vomiting|To test that Danish infants who get the BCG vaccine at birth develop less episodes with diarrhoea and vomiting at 13 months of age than non-BCG-immunised infants.|13 months of age|This analysis only includes children with available follow-up data. As opposed to the primary outcome, follow-up for this outcome was lower than 100%.||Events|||Number
670852|NCT01694108|Secondary|Number of Events of Febrile Episodes|To test that Danish infants who get the BCG vaccine at birth get less febrile episodes at 13 months of age than non-BCG-immunised infants.|13 months of age|This analysis only includes children with available follow-up data. As opposed to the primary outcome, follow-up for this outcome was lower than 100%.||Events|||Number
670853|NCT01694108|Secondary|Number of Events of Pneumonia|To test that Danish infants who get the BCG vaccine at birth get less pneumonia at 13 months of age than non-BCG-immunised infants.|13 months of age|This analysis only includes children with available follow-up data. As opposed to the primary outcome, follow-up for this outcome was lower than 100%.||Events|||Number
670854|NCT01694108|Secondary|Number of Events of Common Cold|To test that Danish infants who get the BCG vaccine at birth experience less events of common cold until 13 months of age than non-BCG-immunised infants.|13 months of age|This analysis only includes children with available follow-up data. As opposed to the primary outcome, follow-up for this outcome was lower than 100%.||Events|||Number
670855|NCT01694108|Secondary|Number of Participants With Antibody Concentration (AC) Against Tetanus of > 0.1 IU/mL|To test the tetenus antibody response in BCG-vaccinated vs. non-BCG vaccinated children following routine immunisation against tetanus at 3, 5 and 12 months of age in blood samples obtained 13 months of age.|13 months of age|This outcome was a sub-study with 158 participants. Antibody concentration (AC) of > 0.1 IU/mL was considered protective||participants|||Number
670856|NCT01694108|Secondary|Interferon Gamma Response|To test that infants who receive the BCG at birth respond in interferon-gamma response upon stimulation with BCG. The interferon gamma response was defined as a value above the cut-off value of 107 pg/ml.|13 months of age|This is a sub study using bloodsamples. Only a small sub population from the overall trial participated.||participants|||Number
670857|NCT01694108|Secondary|Monocyte Count 4 Days After Randomisation/Vaccination|To test if infants who receive the BCG at birth respond in monocyte count measured as geometric mean (GM) cell concentrations (GM*10^9 cells/L).|4 days after randomisation/vaccination within 7 days after birth|This was a sub study among 153 children with blood-samples at 4 days after randomisation/vaccination.||Cell concentrations (GM*10^9 cells/L)||95% Confidence Interval|Geometric Mean
670858|NCT01694108|Secondary|Leucocyte Count 4 Days After Randomisation/Vaccination|To test if infants who receive the BCG at birth respond in leucocyte count (white blood cell count) measured as geometric mean (GM) cell concentrations (GM*10^9 cells/L).|4 days after randomisation/vaccination within 7 days after birth|This was a sub study among 153 children with blood-samples at 4 days after randomisation/vaccination.||cell concentrations (GM*10^9 cells/L)||95% Confidence Interval|Geometric Mean
670859|NCT01694108|Secondary|Thymic Gland Size at 3 Months of Age|To test that infants who receive the BCG at birth respond in thymic gland size defined by ultra sound examination. First, the thymus gland was identified in a horizontal scanning plane and the largest transverse diameter of the thymus was obtained. Second, in a sagittal scanning plane, the area of the largest lobe was assessed. Both measurements were obtained twice, and in case of more than 15% difference, both measurements were repeated. The mean of the two measurements were multiplied and defined as the thymic index.|3 months of age|This outcome was a sub-study to The Danish Calmette Study with 301 (BCG 153, Control 148) participating children.||Thymic index||95% Confidence Interval|Mean
670860|NCT01694108|Secondary|Standardized Head Circumference at 13 Months of Age|To test if infants who get the BCG vaccine at birth respond in head circumference. The Z-score indicates the number of standard deviations away from the mean weight-for-age of the WHO anthropometric reference population (http://www.who.int/childgrowth/standards/en/). A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean.|13 months|This analysis only includes children with available follow-up data. As opposed to the primary outcome, follow-up for this outcome was lower than 100%.||Head circumference z-score||Standard Deviation|Mean
670861|NCT01694108|Secondary|Length at 13 Months of Age|To test if infants who get the BCG vaccine at birth respond in length. The Z-score indicates the number of standard deviations away from the mean weight-for-age of the WHO anthropometric reference population (http://www.who.int/childgrowth/standards/en/). A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean.|13months|This analysis only includes children with available follow-up data. As opposed to the primary outcome, follow-up for this outcome was lower than 100%.||Length z-score||Standard Deviation|Mean
670862|NCT01694108|Secondary|Food Allergy|Number of participants with food allergy diagnosed by a physician and mentioned in the telephone interview at 13 months of age|13 months|This analysis only includes children with available follow-up telephone interview data. As opposed to the primary outcome, follow-up was lower than 100%.||participants|||Number
670863|NCT01694108|Secondary|Episodic Viral Wheeze|Number of participants diagnosed with episodic viral wheeze by a physician and treated with anti-asthmatic medicine according to the telephone interview.|13 months|This analysis only includes children with available follow-up telephone interview data. As opposed to the primary outcome, follow-up was lower than 100%.||participants|||Number
670864|NCT01694108|Secondary|Standardized Weight, Length and Head Circumference of Premature Children at 13 Months|The Z-score indicates the number of standard deviations away from the mean weight-for-age of the WHO anthropometric reference population (http://www.who.int/childgrowth/standards/en/). A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean.|13 months of age|Premature children born with gestational age 32-36 weeks. This analysis only includes children from a particular subgroup (premature children, N = 144), who had with available follow-up data. As opposed to the primary outcome, follow-up was lower than 100%.||z-score||Standard Deviation|Mean
670865|NCT01694108|Secondary|DTaP-IPV-Hib Vaccination Coverage at 12 Months of Age|To test that infants who get the BCG vaccine at birth has unaffected coverage with the subsequent 3rd diphtheria, tetanus, acellular pertussis, polio, Haemophilus influenzae type b (DTaP-IPV-Hib) vaccination scheduled to 12 months of age according to the Danish child vaccination programme. Since we did not expect all children to get their immunizations exactly at 12 months of age, the children were followed up until 13-months of age.|13 months of age|Per-protocol analysis excluding 11 children randomised to BCG who did not receive the vaccine, and 36 children randomised to control who received the BCG vaccine.||participants|||Number
670866|NCT01694108|Secondary|Psychomotor Development in Premature Infants|To test that premature infants with gestational age less than 37 weeks who get the BCG vaccine at birth have unaffected psychomotor development measures: ASQ: Ages and stages questionnaire – a parent reported questionnaire that measures child psychomotor development. Total range of ASQ score: 0 to 300 points. Higher scores indicate higher level of psychomotor development.|13 months of age|This analysis only includes children from a particular subgroup (premature children, N = 144), who had with available follow-up data. As opposed to the primary outcome, follow-up was lower than 100%.||Score on ASQ scale||Standard Deviation|Mean
670867|NCT01694108|Secondary|Standardized Weight at 13 Months|To test that infants who get the BCG vaccine at birth respond in weight.The Z-score indicates the number of standard deviations away from the mean weight-for-age of the WHO anthropometric reference population (http://www.who.int/childgrowth/standards/en/). A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean.|13 months of age|This analysis only includes children with available follow-up data from telephone interviews or clinical examinations. As opposed to the primary outcome, follow-up was lower than 100%.||Weight z-score at 13 months||Standard Deviation|Mean
670869|NCT01694108|Secondary|Atopic Dermatitis|"To test if BCG vaccination within 7 days after birth influence the risk of atopic dermatitis defined by clinical examination at 13 months of age using scoring atopic dermatitis (SCORAD) or by parental report of physician diagnosed atopic dermatitis in the telephone interview at 13 months of age."|13 months of age|This analysis includes children with follow-up data from clinical examination or telephone interview. As opposed to the register-based primary outcome, adherence to telephone-interview and clinical examination was slightly lower than 100%.||participants|||Number
670870|NCT01694108|Secondary|Antibiotics|To test that infants who get the BCG vaccine at birth are prescribed less antibiotics during early childhood than non-BCG-immunised infants. Use of antibiotics was defined as one or more precriptions of systemic antibiotics (ATC groups J01, J02, J05, all subgroups inclusive).|0-15 months of age|Intention-to-treat||participants|||Number
670871|NCT01694108|Primary|All-cause Hospitalisations|To test that infants who get the BCG vaccine at birth experience 20% fewer hospitalisations in early childhood than non-BCG-immunised infants.|0-15 months of age|Intention-to-treat||Events|||Number
670872|NCT01693900|Secondary|Patient Satisfaction With Postoperative Pain Control|Patient satisfaction with postoperative pain control, using a 10 point Likert scale where 1=extremely dissatisfied and 10= extremely satisfied. Patients were called 3 weeks post-op to determine pain control satisfaction.|At the 3 week post-op visit|Data was obtained for the 25 patients in the pre-operative group and 22 patients in the intra-operative group who responded to 3-week followup phone calls.||units on a scale||Standard Deviation|Mean
670873|NCT01693900|Secondary|Incidence of Adverse Events|Measure is count of participants experiencing any adverse event. Adverse events will be reported by the patient (or when appropriate, staff personnel) during hospitalization.|From the signature on the informed consent document for the duration of the hospital stay, an expected average of 2 - 3 days.|Data lost for one participant in Intra-operative FICB group leaving 24 analyzed.||Participants|||Count of Participants
670874|NCT01693900|Primary|Postoperative Pain During Recovery|Pain assessments were made by the subject using a 10.0 mm VAS (scale 1-100 where 1=minimal pain and 100= worst pain imaginable) prior to any request for pain medication. Up to 40 values per patient were averaged.|From discharge from PACU until discharge from hospital, an average of 2-3 days|Data not available for 1 patient in Pre-operative ultrasound FICB group and 3 patients Intra-operative FICB group||units on a scale||Inter-Quartile Range|Median
670875|NCT01693900|Primary|Postoperative Pain During PACU Admission|"Pain assessments will be made by the subject using a 10.0 mm Visual-Analog scale (VAS) (scale 1-100 where 1=minimal pain and 100= worst pain imaginable) as follows at each time point:
Baseline assessment in Preoperative area
Upon arrival to the post-anesthesia care unit (PACU)
Every 15 min (+/- 2 minutes) thereafter and prior to any request for pain medication until PACU discharge"|From time of PACU admission until discharge from PACU, an average of 2 hours|Data lost for one participant in Intra-operative FICB group leaving 24 analyzed.||units on a scale||Inter-Quartile Range|Median
670886|NCT01693484|Primary|Perfusion Data Infection Wound Healing Complication|correlation of multiple absolute and relative data points acquired from near infra red spectroscopy compared to clinical postoperative infection or wound healing complication following lateral approach calcaneus fracture|3 months postoperative|unable to complete analysis as correlation between clinical and ICG near infra red data acquisition could not be completed do to unexpected lack funding required to pair and analyze extremely large data sets with clinical information as well as too few numbers of patients|||||
670887|NCT01693367|Secondary|WOMAC|To assess pain, stiffness, and physical function|Preoperative, 6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery|Five patients signed the informed consent form and were enrolled in the study before it was terminated. Three of the five patients were post-enrollment drop-outs and only two patients completed all study follow-up visits. No analysis was done. Due to the low number of patients an analysis was not indicated, therefore no results are available.|||||
670888|NCT01693367|Secondary|Full Weight-bearing Status|"Assessment of the timepoint when the patient :
can bear the whole body weight on the affected leg at single-leg-stance for 3 seconds
can walk without walking aid
has no intake of analgesics
has a pain level experienced at the fracture site during weight bearing over two consecutive measurements with a value of ≤ 3 as measured on a 0-10 numeric rating scale (NRS), where 0 = no pain and 10 = worst pain imaginable"|weekly measurement at home|Five patients signed the informed consent form and were enrolled in the study before it was terminated. Three of the five patients were post-enrollment drop-outs and only two patients completed all study follow-up visits. No analysis was done. Due to the low number of patients an analysis was not indicated, therefore no results are available.|||||
670889|NCT01693367|Secondary|Range of Motion (ROM)|Assessment of passive ROM of the knee (flexion – extension)|6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery|Five patients signed the informed consent form and were enrolled in the study before it was terminated. Three of the five patients were post-enrollment drop-outs and only two patients completed all study follow-up visits. No analysis was done. Due to the low number of patients an analysis was not indicated, therefore no results are available.|||||
670890|NCT01693367|Secondary|Quality of Life (EuroQol-5D)||Preoperative, 6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery|Five patients signed the informed consent form and were enrolled in the study before it was terminated. Three of the five patients were post-enrollment drop-outs and only two patients completed all study follow-up visits. No analysis was done. Due to the low number of patients an analysis was not indicated, therefore no results are available.|||||
670891|NCT01693367|Secondary|Timed Up-and-go Test (TUG)|"The TUG measures the time (in seconds) that it takes for an individual to rise from an armchair (chair seat height = 45 cm / 1.5 feet), walk 3 meters (= 10 feet) to a line drawn on the floor, turn around and return to the chair. The time is measured from a seated position (back against the backrest) with a stopwatch started on the command ready - go and stopped when the seated position is reached again."|12 weeks ± 7 days, 6 months ± 30 days|Five patients signed the informed consent form and were enrolled in the study before it was terminated. Three of the five patients were post-enrollment drop-outs and only two patients completed all study follow-up visits. No analysis was done. Due to the low number of patients an analysis was not indicated, therefore no results are available.|||||
670892|NCT01693367|Primary|Western Ontario and McMaster Universities Index (WOMAC)|To assess pain, stiffness, and physical function|12 months after surgery|Five patients signed the informed consent form and were enrolled in the study before it was terminated. Three of the five patients were post-enrollment drop-outs and only two patients completed all study follow-up visits. No analysis was done. Due to the low number of patients an analysis was not indicated, therefore no results are available.|||||
670893|NCT01693185|Secondary|Indigence of Patient's Recall|The numbers of patients who recalled instructions and explanations given during colonoscopy|after colonoscopy|||participants|||Number
670894|NCT01693185|Secondary|Endoscopist Satisfaction|endoscopist's satisfaction after colonoscopy in visual analogue scale 100 mm|5 min after the colonoscopy|||units on a scale||Inter-Quartile Range|Median
670895|NCT01693185|Secondary|Patient's Distress Score|patients' distress in visual analogue scale 100 mm minimal distress=0, maximal distress=100|5 min after the end of colonoscopy|||units on a scale||Inter-Quartile Range|Median
670896|NCT01693185|Secondary|Bispectra Lindex Score|Bispectral index (BIS) score 0-100 maximal sedation=0, maximal sedation=100|every 5 min during and after colonoscopy|||units on a scale||Full Range|Median
670897|NCT01693185|Secondary|Participants Assumed to Feel Frequent Pain|"patients sound Ah at feeling pain during colonosocpy: if a patients sounds Ah > 6 times, the patient was assumed to feel frequent pain."|during and after colonoscopy|||participants|||Number
670898|NCT01693185|Primary|The Recovery Time|"Time from completing the colonoscopy to achieving Aldrete score 10 in the recovery unit
Aldrete score
Respiration: Able to take deep breath and cough = 2, Dyspnea/shallow breathing = 1, Apnea = 0
O2 saturation: Maintains > 92% on room air =2, Needs O2 inhalation to maintain O2 saturation > 90% =1 , O2 saturation < 90% even with supplemental oxygen =0
Consciousness: Fully awake= 2, Arousable on calling = 1, Not responding = 0
Circulation: BP +/- 20 mm Hg preop =2, BP +/- 20-50 mm Hg preop =1, BP +/- 50 mm Hg preop =0
Activity: Able to move 4 extremities = 2, Able to move 2 extremities = 1, Able to move 0 extremities = 0
To estimate the required sample size, we conducted a pilot study to measure the recovery of 10 patients in each of groups-MM and –R before the present study. The means and standard deviations were 22.5 ± 9.5 and 7.5 ± 9.2 min respectively. We wished to be able to distinguish a difference of 7.5 min, thus half of the observed difference."|every 5 minutes after completing colonoscopy up to 30 min|||minute||Inter-Quartile Range|Median
670899|NCT01693029|Secondary|Incidence of Antibody Formation Against Epoetin|Number of patients with positive antidrug antibody (ADA) finding at any time during their treatment period. Count includes 2 patients (1 in each arm) that already had a positive ADA Baseline finding. ADA testing performed by by Radio-Immuno-Precipitation assay. No patient developed neutralizing antibodies.|52 weeks|All patients treated with study drug with a post-baseline antibody assessment||Participants|||Count of Participants
670900|NCT01693029|Secondary|Mean Weekly Dose During Evaluation Period (Week 21-28)|Mean weekly study drug dose during evaluation period (Week 21-28)|Week 21-28|The intent-to-treat (ITT) population consists of all randomized patients who were exposed to treatment with study drug for at least four weeks and have at least one Hb value available at week 4 or later. Following the intent-to-treat principle, patients are analyzed according to the treatment they were assigned to at randomization.||international units||Standard Deviation|Mean
670901|NCT01693029|Primary|Change in Mean Hb Level Between Baseline (Week -4 to Day1) and Evaluation Period (Week 21-28)|Response to epoetin alfa in anemic patients with chronic renal failure is manifested by increased hematocrit, hemoglobin, reduced transfusion requirements and increase in quality of life. Hemoglobin (laboratory haematology parameter) is the primary endpoint of the study .|Week -4 to Day1 and Week 21-28|The intent-to-treat (ITT) population consists of all randomized patients who were exposed to treatment with study drug for at least four weeks and have at least one Hb value available at week 4 or later. Following the intent-to-treat principle, patients are analyzed according to the treatment they were assigned to at randomization.||g/dL||Standard Deviation|Mean
670902|NCT01693029|Primary|Mean Absolute Change in Hemoglobin Levels Between the Screening/Baseline Period (Week -4 to Day 1) and the Evaluation Period (Week 21-28)|Response to epoetin alfa in anemic patients with chronic renal failure is manifested by increased hematocrit, hemoglobin, reduced transfusion requirements and increase in quality of life. Hemoglobin (laboratory haematology parameter) is the primary endpoint of the study .|Week -4 to Day1 and Week 21-28|The intent-to-treat (ITT) population consists of all randomized patients who were exposed to treatment with study drug for at least four weeks and have at least one Hb value available at week 4 or later. Following the intent-to-treat principle, patients are analyzed according to the treatment they were assigned to at randomization.||g/dL||Standard Error|Least Squares Mean
670903|NCT01692951|Primary|Compare Concentration of Fatty Acids and Their Metabolites|Biochemical analysis of serum sample was conducted by an investigator who was strictly blinded to cancer status and patient characteristics.|At the time of diagnosis, prior to the initiation of lung cancer treatment|||mg/mL||Inter-Quartile Range|Median
670921|NCT01692301|Secondary|Change From Baseline in Mean 24-hour Ambulatory Pulse Pressure (maPP)|Mean 24 hour ambulatory pulse pressure was calculated as the difference between the mean 24 hour systolic and diastolic ambulatory blood pressure in corresponding visits i.e. baseline, week 12 and week 52.|Baseline, 12 weeks, and 52 weeks|Full analysis set (FAS): All patients who were randomized. This endpoint included number of patients who had values at both baseline and endpoints (week 12, week 52).||mmHg||Standard Error|Least Squares Mean
670904|NCT01692938|Primary|Repeatability of Microperimetry Tests in Normal and With Pathology Participants Based on 3 Microperimetry Tests Taken for Each Participant for a Given Operator-device Combination.|A precision study was conducted that used 3 devices (each with a different operator). Each device was used to measure 4 normal subjects and 4 subjects with relevant eye pathology, with a total of 24 subject eyes (12 normal, 12 with pathology) measured across all three devices. Test results were given in decibels as that is the standard measurement in microperimetry testing. For each subject, one eye was evaluated using 3 microperimetry tests with repositioning at the start of each test. Overall Repeatability SD and Repeatability SD Limit were calculated for the two groups: normal and with pathology.|1 Month|||decibels||Standard Deviation|Mean
670905|NCT01692938|Primary|Standard Deviation and Mean Test Results of Normal and With Pathology Participants Taken by 3 Different Operator-device Configurations|A precision study was conducted that used 3 devices (each with a different operator). Each device was used to measure 4 normal subjects and 4 subjects with relevant eye pathology, with a total of 24 subject eyes (12 normal, 12 with pathology) measured across all three devices. For each subject, one eye was evaluated using 3 tests with repositioning at the start of each test. Test results were given in decibels which is the unit used in microperimetry testing. Overall mean and standard deviation in decibels were calculated for the two groups: normal and with pathology.|1 Month|||decibels||Standard Deviation|Mean
670906|NCT01692782|Secondary|Change From Baseline in the Wender-Reimher Adult Attention Deficit Disorder Scale (WRAADDS) as Measured at Weeks 1, 2, 3, 4.|The WRAADDS measured the severity of the target symptoms of adults with ADHD. It measured symptoms in 7 categories: attention difficulties, hyperactivity/restlessness, temper, affective lability, emotional overreactivity, disorganization, and impulsivity. The scale rated individual items from 0 to 2 (0 = not present, 1 = mild, 2 = clearly present) and summarized each of the 7 categories on a 0 to 4 scale (0 = none, 1 = mild, 2 = moderate, 3 = quite a bit, 4 = very much). The WRAADDS total score is defined as sum of all 28 item subscores (range 0 - 56).|Weeks 1, 2, 3, 4|Intent to treat||units on a scale||Standard Error|Least Squares Mean
670907|NCT01692782|Secondary|The Number of Responders at Weeks 1, 2, 3, 4. A Responder is Defined as a Subject With a ≥ 30% Improvement in ADHD Symptoms Compared With Baseline as Measured by the ADHD RS IV.||Weeks 1, 2, 3, 4|Intent to treat||participants|||Number
670908|NCT01692782|Secondary|Change From Baseline in the Inattentiveness and Hyperactivity Subscales of the ADHD RS IV at Weeks 1, 2, 3, 4|The ADHD RS-IV with adult prompts is an 18 item scale based on the DSM IV TR criteria for ADHD that provides a rating of the severity symptoms. Scoring is based on a 4 point Likert-type severity scale where 0 = none, 1 = mild, 2 = moderate, and 3 = severe. Clinicians scored the highest score that was generated for the prompts for each item. The even number items (2, 4, 6, 8, 10, 12, 14, 16, 18) assess hyperactive impulsive symptoms and the odd number items (1, 3, 5, 7, 9, 11, 13, 15, 17) assess inattentive symptoms. The ADHD inattentiveness subscale score is defined as sum of items (1, 3, 5, 7, 9, 11, 13, 15, 17) scores (range 0 - 27). The ADHD hyperactive impulsive subscale score is defined as sum of items (2, 4, 6, 8, 10, 12, 14, 16, 18) scores (range 0 - 27).|Weeks 1, 2, 3, 4|Intent to treat||units on a scale||Standard Error|Least Squares Mean
670909|NCT01692782|Secondary|Change From Baseline in Clinical Global Impression - Severity of Illness Scale (CGI S) at Weeks 1, 2, 3, 4.|The CGI-S modified asked the clinician one question: Considering your total clinical experience with adult ADHD, how mentally ill is the subject at this time?”.The clinician’s answer was rated on the following 7-point scale: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = ng the most extremely ill subjects.|Weeks 1, 2, 3, 4|Intent to treat||units on a scale||Standard Error|Least Squares Mean
670910|NCT01692782|Secondary|Change From Baseline in ADHD Symptoms Measured With the ADHD RS IV at Weeks 1, 2, 3.|The ADHD RS-IV with adult prompts is an 18 item scale based on the DSM IV TR criteria for ADHD that provides a rating of the severity symptoms. Scoring is based on a 4 point Likert-type severity scale where 0 = none, 1 = mild, 2 = moderate, and 3 = severe. Clinicians scored the highest score that was generated for the prompts for each item. The ADHD rating scale total score is defined as sum of all 18 item scale scores (range 0 - 54).|Weeks 1, 2, 3|Intent to treat population||units on a scale||Standard Error|Least Squares Mean
670911|NCT01692782|Primary|Change From Baseline at Week 4 in ADHD Symptoms Measured With the ADHD Rating Scale Version IV With Adult Prompts (ADHD RS IV)|The ADHD RS-IV with adult prompts is an 18 item scale based on the DSM IV TR criteria for ADHD that provides a rating of the severity symptoms. Scoring is based on a 4 point Likert-type severity scale where 0 = none, 1 = mild, 2 = moderate, and 3 = severe. Clinicians scored the highest score that was generated for the prompts for each item. The ADHD rating scale total score is defined as sum of all 18 item scale scores.|4 Weeks|Intent to treat population||units on a scale||Standard Error|Least Squares Mean
670916|NCT01692626|Primary|Percentage of Participants That do Not Experience Rash From Cetuximab Treatment on the Pimecrolimus Side of the Face.|To determine if 1% pimecrolimus prevents the rash associated with treatment with cetuximab, as assessed by lesion counts on clinical photographs after two weeks of treatment.|2 weeks|||Participants|||Count of Participants
670917|NCT01692340|Primary|Time of Maximal Carotenoid Concentration|We will determine when the maximal carotenoid concentration is achieved in the plasma|0 to 48 hours|||hours||Standard Error|Mean
670918|NCT01692340|Primary|Maximal Plasma Carotenoid Concentration|We will determine the average maximal plasma carotenoid concentration in healthy volunteers|0 to 48 hours|||micromol||Standard Error|Mean
670919|NCT01692340|Secondary|Carotenoid Metabolites|Study the metabolites produced from the labeled carotenoid in healthy subjects|Up to 28 days|Due to funding issues, at present we have not analyzed these samples for carotenoid metabolites.|||||
670920|NCT01692340|Primary|Plasma Half Life of Labeled Carotenoid|We will study the half life of isotopically labeled carotenoids.|labelled lycopene: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose. Labelled phytoene: hourly for hours 0 - 15, then hours 17, 19 and 21 hours after dosing. Then, 1, 2, 3 4, 7, 10, 14, 17, 21 and 28 days post dose.|||days||Standard Error|Mean
670922|NCT01692301|Secondary|Change From Baseline in Mean 24-hour Diastolic Blood Pressure (maDBP)|An Ambulatory Blood Pressure Monitor (ABPM) measured a participant's blood pressure over a 24 hour period using an automated validated monitoring device at baseline, week 12 and at week 52 starting one day before each visit. The 24 hour maDBP was calculated by taking the mean of all ambulatory systolic blood pressure readings for the 24 hour period.|Baseline, 12 weeks, and 52 weeks|Full analysis set (FAS): All patients who were randomized. This endpoint included number of patients who had values at both baseline and endpoints (week 12, week 52).||mmHg||Standard Error|Least Squares Mean
670923|NCT01692301|Secondary|Change From Baseline in Mean 24-hour Systolic Blood Pressure (maSBP)|An Ambulatory Blood Pressure Monitor (ABPM) measured a participant's blood pressure over a 24 hour period using an automated validated monitoring device at baseline, week 12 and at week 52 starting one day before each visit. The 24 hour maSBP was calculated by taking the mean of all ambulatory systolic blood pressure readings for the 24 hour period.|Baseline, 12 weeks, and 52 weeks|Full analysis set (FAS): All patients who were randomized. This endpoint included number of patients who had values at both baseline and endpoints (week 12, week 52).||mmHg||Standard Error|Least Squares Mean
670924|NCT01692301|Secondary|Change From Baseline in Mean Arterial Pressure (MAP)|Mean arterial pressure (MAP) was calculated from mean sitting systolic BP (msSBP) and mean sitting diastolic BP (msDBP) as (2 * msDBP + msSBP)/3.|baseline, 12 weeks, and 52 weeks|Full analysis set (FAS): All patients who were randomized. This endpoint included number of patients who had values at both baseline and endpoints (week 12, week 52).||mmHg||Standard Error|Least Squares Mean
670925|NCT01692301|Secondary|Change From Baseline in Mean Sitting Pulse Pressure (msPP)|Mean sitting pulse pressure for each patient and visit was calculated as the difference between the calculated values of mean sitting systolic blood pressure and mean sitting diastolic blood pressure.|baseline, 12 weeks, and 52 weeks|Full analysis set (FAS): All patients who were randomized. This endpoint included number of patients who had values at both baseline and endpoints (week 12, week 52).||mmHg||Standard Error|Least Squares Mean
670926|NCT01692301|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)|At the first study visit, the patient had his/her blood pressure (BP) measured in both arms; the arm in which the highest sitting SBP was found was used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for 5 minutes, DBP were measured 3 times using a standard mercury sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1- to 2-minute intervals and the mean of those 3 measurements was used as the average sitting office BP for that visit.|baseline, 12 weeks, and 52 weeks|Full analysis set (FAS): All patients who were randomized. This endpoint included number of patients who had values at both baseline and endpoints (week 12, week 52).||mmHg||Standard Error|Least Squares Mean
670927|NCT01692301|Secondary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)|At the first study visit, the patient had his/her blood pressure (BP) measured in both arms; the arm in which the highest sitting SBP was found was used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for 5 minutes, SBP were measured 3 times using a standard mercury sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1- to 2-minute intervals and the mean of those 3 measurements was used as the average sitting office BP for that visit.|baseline, 12 weeks, and 52 weeks|Full analysis set (FAS): All patients who were randomized. This endpoint included number of patients who had values at both baseline and endpoints (week 12, week 52).||mmHg||Standard Error|Least Squares Mean
670928|NCT01692301|Secondary|Change From Baseline in Mean Central Aortic Systolic Pressure (CASP) at 52 Weeks|"Central aortic blood pressure was derived from peripheral pressure waveforms recorded noninvasively from the brachial artery using a cuff-based device. This technique uses the brachial pressure and a signal processing algorithm to transform brachial signals into central blood pressure (BP) waveforms. When the aortic pressure waveform was derived, key pulse wave analysis (PWA) parameters, such as CASP was calculated by the system software.
At the first study visit, the arm with the highest systolic blood pressure (SBP) was used for all subsequent PWA. Brachial PWA measurements were performed on the same arm that the office blood pressures were taken. Two pulse waveform measurements, meeting all quality control criteria were captured at baseline and at week 12 visits."|baseline, 52 weeks|Full analysis set (FAS): All patients who were randomized. This endpoint included number of patients who had values at both baseline and endpoint (week 52). Four patients did not have a successful CASP assessment at Week 12 but passed quality check at Week 52, thus 4 more patients were included in the Week 52 Endpoint analysis.||mmHg||Standard Error|Least Squares Mean
670929|NCT01692301|Secondary|Change From Baseline in Mean Pulse Wave Velocity (PWV)|"Pulse wave velocity recordings were performed on patient while in a supine, face-up position.
Tonometry was performed on the carotid simultaneously with the cuff inflation over the femoral artery. Two pulse wave velocity measures, meeting all quality control criteria were captured at baseline, week 12 and week 52."|baseline, 12 weeks, and 52 weeks|Full analysis set (FAS): All patients who were randomized. This endpoint included number of patients who had values at both baseline and endpoint (week 12 , week 52).||meter/second||Standard Error|Least Squares Mean
670930|NCT01692301|Secondary|Change From Baseline in Mean Central Pulse (CPP) Pressure||Baseline, 12 weeks, and 52 weeks|Full analysis set (FAS): All patients who were randomized. This endpoint included number of patients who had values at both baseline and endpoint (week 12, week 52). Four patients did not have a successful CASP assessment at Week 12 but passed quality check at Week 52, thus 4 more patients were included in the Week 52 Endpoint analysis||mmHg||Standard Error|Least Squares Mean
670931|NCT01692301|Primary|Change From Baseline in Mean Central Aortic Systolic Pressure (CASP) at 12 Weeks|"Central aortic blood pressure was derived from peripheral pressure waveforms recorded noninvasively from the brachial artery using a cuff-based device. This technique uses the brachial pressure and a signal processing algorithm to transform brachial signals into central blood pressure (BP) waveforms. When the aortic pressure waveform was derived, key pulse wave analysis (PWA) parameters, such as CASP was calculated by the system software.
At the first study visit, the arm with the highest systolic blood pressure (SBP) was used for all subsequent PWA. Brachial PWA measurements were performed on the same arm that the office blood pressures were taken. Two pulse waveform measurements, meeting all quality control criteria were captured at baseline and at week 12 visits."|baseline, 12 weeks|Full analysis set (FAS): All patients who were randomized. This endpoint included number of patients who had values at both baseline and endpoint (week 12).||mmHg||Standard Error|Least Squares Mean
670932|NCT01691885|Primary|Mean Change From Baseline in Right Ventricular End Diastolic Volume Index (RVEDVI) at the End of the Overall Treatment Period|RVEDVI is a measure of the volume of blood in the right ventricle at the end of diastole, normalized over body surface area and was measured using Cardiac Magnetic Resonance (CMR) imaging. RVEDVI is calculated as the right ventricular end diastolic volume (RDEDV) divided by the body surface area (BSA). The change from Baseline in RVEDVI was analyzed using a mixed model analysis with period, treatment group, and Baseline RVEDVI fitted as fixed effects and participants fitted as a random effect. The Baseline is defined as the assessment performed pre-dose at Day 1 of Treatment Period 1. The change from Baseline is calculated as the RVEDVI value at the end of each treatment period minus the Baseline value. The Per Protocol (PP) Population was comprised of all participants in the modified intent-to-treat (mITT) Population not identified as having deviations considered to impact the primary efficacy analysis.|Baseline and end of Treatment Period (7 days)|PP Population. Only those participants available at the specified time points were analyzed||Milliliter per meter square (mL/m^2)||Standard Error|Least Squares Mean
670933|NCT01691794|Primary|Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued)|Blood urea nitrogen (*upper limit of normal [ULN]): Grade (Gr) 1=1.25-2.5; Gr 2=2.6-5.0; Gr 3=5.1-10; Gr 4= >10. Uric acid (mg/dL): Gr 1=7.5-10.0; Gr 2=10.1-12; Gr 3=12.1-15.0; Gr 4= >15.0. Bicarbonate (mEqL): Gr 1= 19.0-21.0; Gr 2=15.0-18.0; Gr 3=41-45; Gr 4= >45. Calcium, low (mg/dL): Gr 1=7.8-8.4; Gr 2=7.0-7.7; Gr 3=6.1-6.9; Gr 4= <6.1.Potassium (mEq/L), high: Gr 1=5.6-6.0; Gr 2=6.1-6.5; Gr 3=6.6-7.0; Gr 4= >7.0. Potassium (mEq/L), low: Gr 1=3.1-3.4; Gr 2=2.5-2.9; Gr 3=2.0-2.4; Gr 4= <2.0. Sodium (mEq/L), low: Gr 1=130-135; Gr 2=125-129; Gr 3=121-124; Gr 4= <1. Total cholesterol, fasting (mg/dL): Gr 1=200-239; Gr 2=240-300; Gr 3= >300; Gr 4=Not applicable (NA). Low-density lipoprotein (LDL) cholesterol, fasting (mg/dL): Gr 1=130-159; Gr 2=160-190; Gr 3= >190; Gr 4= NA. Glucose, low (mg/dL): Gr 1= 55-64; Gr 2=40-54; Gr 3=30-39; Gr 4= <30. Glucose, fasting (mg/dL): Gr 1=110-125; Gr 2=126-250; Gr 3=251-500; Gr 4 >500.|Day 1 of treatment through Week 24|All participants who received at least 1 dose of study drug||Participants|||Number
670934|NCT01691794|Primary|Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4|Hematocrit (%): Grade (Gr) 1= ≥28.5- <31.5; Gr 2= ≥24- <28.5; Gr 3= ≥19.5- <24; Gr 4= <19.5. Hemoglobin (g/dL): Grade (Gr)1=8.5-10.0; Gr 2=7.5-8.4; Gr 3=6.50-7.4; Gr 4= <6.5. Platelets (/mm^3): Gr 1=100,000-124,999; Gr 2=50,000-99,999; Gr 3=25,000-49,999; Gr 4= <25,000. White blood cells (/mm^3): Gr 1=2000-2500; Gr 2=1500-1999; Gr 3=1000-1499; Gr 4= <1000. Neutrophils (/mm^3): Gr 1=1000-1500; Gr 2= ≥750-1000; Gr 3= ≥500-750; Gr 4= <500. Alanine transaminase (ALT), alkaline phosphatase (ALP), aspartate transaminase (AST) (*upper limit of normal [ULN]): Gr 1=1.5-2.5; Gr 2=2.6-5.0; Gr 3=5.1-10.0; Gr 4= >10.0. Total bilirubin (adult and pediatric >14 days) (*ULN): Gr 1=1.1-1.5; Gr 2=1.6-2.5; Gr 3=2.6-5.0; Gr 4= >5.0. Albumin (g/dL): Gr 1= 3.1- <LLN; Gr 2=2.0-2.9; Gr 3= <2.0; Gr 4=NA. Amylase (*ULN): Gr 1=1.10-1.39; Gr 2=1.40-2.09; Gr 3=2.10-5.0; Gr 4= >5. Lipase (*ULN): Gr 1=1.1-1.5; Gr 2=1.6-3.0; Gr 3=3.1-5.0; Gr 4= >5.0.|Day 1 of treatment to Week 24|All participants who received at least 1 dose of study drug||Participants|||Number
670935|NCT01691794|Primary|Number of Participants Who Died and With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, Grade 2-4 Related AEs, Grade 3-4 AEs, and Centers for Disease Control (CDC) Class C AIDS Events|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or unknown relationship to study drug. Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death.|Day 1 of treatment through Week 24|All participants who received at least 1 dose of study drug||Participants|||Number
670936|NCT01691781|Secondary|Serum Calcium Following 1 Week of ACE Inhibitor Administration||1 week|||mg/dL||Standard Deviation|Mean
670937|NCT01691781|Secondary|Urinary Aldosterone Excretion Measurements Following 1 Week of ACE Inhibitor Therapy||1 week|||mcg/24 hours||Standard Deviation|Mean
670938|NCT01691781|Primary|Parathyroid Hormone Following 1 Week of ACE Inhibitor Administration|PTH values 1 week following ACE inhibitor therapy|1 week|||pg/mL||Standard Deviation|Mean
670939|NCT01691690|Secondary|Time of First Opioid Analgesia in PACU|Mean time to first drug administration among patients requiring opioid analgesia in the PACU.|0-90 minutes post-operatively|||minutes||Standard Deviation|Mean
670940|NCT01691690|Secondary|Analgesics Administered After Arrival to Inpatient Ward and Number of Participants Requiring Each|Analgesics administered after arrival to the inpatient ward included hydrocodone/acetaminophen, oxycodone, NSAIDS, acetaminophen, and morphine.|8-12 hours post-operatively|Comparing both groups for the time study subjects required breakthrough pain medication on the ward.||Participants|||Count of Participants
670941|NCT01691690|Primary|FLACC Pain Score Greater Than or Equal to 4|The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0–10 with 0 representing no pain. 5 pain measurements were performed at 0, 5, 15, 30, and 60 minutes after PACU arrival. This is the number of participants who reached a FLACC score >/= 4 at one or more time points.|0-60 mins post-operatively|||Participants|||Count of Participants
670942|NCT01691612|Secondary|Change From Baseline in the Percentage of Total White Blood Cell That Were Neutrophils at 48 Hours|Neutrophils have some zero values pre-challenge, so absolute change is reported instead of percent change: post-pre from baseline to 48 hours|from baseline to 48 hours|||percent of white blood cells||Full Range|Mean
670943|NCT01691612|Secondary|Percent Change From Baseline in the Percentage of Total White Blood Cell That Were Macrophages at 48 Hours|Percent change in percentage of total white blood cell that were macrophages is measured from pre-challenge to post-challenge as: [100% * ((Post-Pre)/Pre)]|from baseline to 48 hours|||percent change||Full Range|Mean
670944|NCT01691612|Secondary|Percent Change From Baseline in the Percentage of Total White Blood Cell That Were Lymphocytes at 48 Hours|Percent change in percentage of total white blood cell that were lymphocytes is measured from pre-challenge to post-challenge as: [100% * ((Post-Pre)/Pre)]|from baseline to 48 hours|||percent change||Full Range|Median
671340|NCT01686451|Other Pre-specified|Treatment Adherence at Week 4 in Simvastatin- and Xuezhikang-group|We counted the total number of pills that were dispensed to the participants at baseline and the total number of pills that were taken by participants at week 4.|Measured at baseline and week 4|||number of pills|||Number
670945|NCT01691612|Primary|Change From Baseline in the Percentage of Total White Blood Cell That Were Eosinophils at 48 Hours|"Measure Pin1 activity in BAL-derived eosinophils after House Dust Mite (HDM) allergen challenge:
Eosinophils post-challenge change from pre-challenge is reported: absolute change = [eosinophils post (%) - eosinophils pre (%)]"|from baseline to 48 hours|||percent of white blood cells||Full Range|Median
670946|NCT01691560|Primary|Change From Baseline in Evaporative Air Sensitivity Response on VRS at Week 8|Participants rated the intensity of their response to the stimulus using a 10 point VRS of 1 (no Pain) to 10 (intense pain).|Baseline to 8 weeks post administration of study treatment|ITT population: All randomized participants administered with at least one study treatment during the study and provided at least one post baseline assessment of efficacy.||Score on a scale||95% Confidence Interval|Least Squares Mean
670947|NCT01691560|Primary|Change From Baseline in Evaporative Air Sensitivity Response on a Visual Rating Scale (VRS) at Week 4|Participants rated the intensity of their response to the stimulus using a 10 point Visual rating scale of 1 (no Pain) to 10 (intense pain).|Baseline to 4 weeks post administration of study treatment|ITT population: All randomized participants administered with at least one study treatment during the study and provided at least one post baseline assessment of efficacy.||Score on a scale||95% Confidence Interval|Least Squares Mean
670948|NCT01691560|Primary|Change From Baseline in Tactile Sensitivity Pain Response (g) at Week 8|Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale. In tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response was recorded or the maximum force was reached.|Baseline to 8 weeks post administration of study treatment|ITT population: All randomized participants administered with at least one study treatment during the study and provided at least one post baseline assessment of efficacy.||grams||Standard Deviation|Mean
670949|NCT01691560|Primary|Change From Baseline in Evaporative Air Sensitivity Pain Response on Schiff Sensitivity Scale at Week 8|Response to a constant jet of air applied to hypersensitive teeth was evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 – participant does not respond to air stimulation, 1 – participant responds to air stimulus but does not request discontinuation of stimulus, 2 - participant responds to air stimulus and request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus.|Baseline to 8 weeks post administration of study treatment|ITT population: All randomized participants administered with at least one study treatment during the study and provided at least one post baseline assessment of efficacy.||Score on a scale||95% Confidence Interval|Least Squares Mean
670950|NCT01691560|Primary|Change From Baseline in Tactile Sensitivity Pain Response (g) at Week 4|Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale. In tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response was recorded or the maximum force was reached.|Baseline to 4 weeks post administration of study treatment|ITT population: All randomized participants administered with at least one study treatment during the study and provided at least one post baseline assessment of efficacy.||grams||Standard Deviation|Mean
670951|NCT01691560|Primary|Change From Baseline in Evaporative Air Sensitivity Pain Response on Schiff Sensitivity Scale at Week 4|Response to a constant jet of air applied to hypersensitive teeth was evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 – participant does not respond to air stimulation, 1 – participant responds to air stimulus but does not request discontinuation of stimulus, 2 - participant responds to air stimulus and request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus.|Baseline to 4 weeks post administration of study treatment|Intent to Treat (ITT) population: All randomized participants administered with at least one study treatment during the study and provided at least one post baseline assessment of efficacy.||Score on a scale||95% Confidence Interval|Least Squares Mean
670952|NCT01691534|Secondary|EBA Expressed as the Daily Percentage Change in TTP Signal in Liquid Culture for M. Tuberculosis (Days 7-14)||Days 7-14|Efficacy population: all patients included in the safety population for whom corresponding efficacy data were available and had no major protocol violations/deviations defined as protocol violations/deviations affecting the integrity of the efficacy data||percentage of change in time/day||95% Confidence Interval|Mean
670953|NCT01691534|Secondary|EBA Expressed as the Daily Percentage Change in TTP Signal in Liquid Culture for M. Tuberculosis (Day 0-2)||Day 0-2|Efficacy population: all patients included in the safety population for whom corresponding efficacy data were available and had no major protocol violations/deviations defined as protocol violations/deviations affecting the integrity of the efficacy data||percentage of change in time/day||95% Confidence Interval|Mean
670954|NCT01691534|Secondary|EBA Expressed as the Daily Percentage Change in Time to Positive (TTP) Signal in Liquid Culture for M. Tuberculosis (Days 0-14)||Days 0-14|Efficacy population: all patients included in the safety population for whom corresponding efficacy data were available and had no major protocol violations/deviations defined as protocol violations/deviations affecting the integrity of the efficacy data||percentage of change in time/day||95% Confidence Interval|Mean
670955|NCT01691534|Secondary|EBA Measured as the Daily Rate of Change in log10 CFUs of M. Tuberculosis in Sputum on Solid Media (Days 7-14)||Day 7-14|Efficacy population: all patients included in the safety population for whom corresponding efficacy data were available and had no major protocol violations/deviations defined as protocol violations/deviations affecting the integrity of the efficacy data||log10CFU/ml/day||95% Confidence Interval|Mean
670956|NCT01691534|Secondary|EBA Measured as the Daily Rate of Change in log10 CFUs of M. Tuberculosis in Sputum on Solid Media (Days 0-2)||Days 0-2|Efficacy population: all patients included in the safety population for whom corresponding efficacy data were available and had no major protocol violations/deviations defined as protocol violations/deviations affecting the integrity of the efficacy data||log10CFU/ml/day||95% Confidence Interval|Mean
670957|NCT01691534|Primary|Early Bactericidal Activity (EBA) Measured as the Daily Rate of Change in log10 CFUs (Colony Forming Units) of M. Tuberculosis in Sputum on Solid Media (Days 0-14).||14 consecutive days of treatment|Efficacy population: all patients included in the safety population for whom corresponding efficacy data were available and had no major protocol violations/deviations defined as protocol violations/deviations affecting the integrity of the efficacy data||log10CFU/ml/day||95% Confidence Interval|Mean
670958|NCT01691521|Secondary|Mean Change From Baseline in the St. George’s Respiratory Questionnaire Total Score at Week 32|The St. George’s Respiratory Questionnaire is an established instrument, comprising 50 questions, evaluating symptoms, activity, and impacts; to measure Quality of Life in participants with diseases of airway obstruction and to elicit the participant's opinion of his/her health. The lowest possible value is zero and the highest possible value is 100. The higher values correspond to greater impairment in quality of life. The questionnaire was administered at Baseline (Visit 2) and at the Exit Visit (approximately 4 weeks after the last dose of study treatment). The change from baseline is defined as the difference between the value of the endpoint at the time point of interest and the baseline value. Analysis performed using analysis of covariance with covariates of baseline, region, baseline maintenance OCS therapy (OCS vs. no OCS), exacerbations in the year prior to the study (as an ordinal variable), baseline % predicted FEV1, and treatment.|Baseline, Week 32|ITT Population. Note that only participants with a Baseline and Week 32 assessment were included in the analysis.||Scores on a scale||Standard Error|Least Squares Mean
670959|NCT01691521|Secondary|Mean Change From Baseline in Clinic Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 32|FEV1 is defined as the volume of air expelled from the lungs in 1 second. Pre-bronchodilator FEV1 measurements were taken by spirometry. The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and the baseline value. Analysis performed using mixed model repeated measures with covariates of baseline, region, baseline maintenance OCS therapy (OCS vs. no OCS), exacerbations in the year prior to the study (as an ordinal variable), treatment and visit, plus interaction terms for visit by baseline and visit by treatment group.|Baseline, Week 32|ITT Population. Only participants with a Baseline FEV1 available and at least one post-Baseline FEV1 measurement were analyzed.||Milliliters (mL)||Standard Error|Least Squares Mean
670960|NCT01691521|Secondary|Number of Clinically Significant Exacerbations Requiring Hospitalization (Including Intubation and Admittance to an ICU) Per Year|Clinically significant exacerbations of asthma is defined as worsening of asthma which required use of systemic corticosteroids (IV or oral steroid like prednisone, for at least 3 days or a single intramuscular (IM) corticosteroid (CS) dose is required. For maintenance of systemic corticosteroids, at least double the existing maintenance dose for at least 3 days was required) and/or hospitalization. The frequency of clinically significant exacerbations of asthma over the 32-week treatment period is expressed as the number of exacerbations per year. Analysis of the number of exacerbations performed using a negative binomial model with covariates of treatment group, baseline maintenance OCS therapy (OCS vs. no OCS), region, exacerbations in the year prior to the study (as an ordinal variable) and baseline % predicted FEV1, and with logarithm of time on treatment as an offset variable.|From randomization (Week 0) to Week 32 or if Early Withdrawal (EW) 4 weeks post last dose|ITT Population||Number of exacerbations per year|||Number
670961|NCT01691521|Secondary|Number of Clinically Significant Exacerbations Requiring Hospitalization (Including Intubation and Admittance to an Intensive Care Unit [ICU]) or ED Visits Per Year|Clinically significant exacerbations of asthma are defined as worsening of asthma which required use of systemic corticosteroids (IV or oral steroid like prednisone, for at least 3 days or a single intramuscular (IM) corticosteroid (CS) dose is required. For maintenance of systemic corticosteroids, at least double the existing maintenance dose for at least 3 days was required) and/or hospitalization and/or emergency department (ED) visits. The frequency of clinically significant exacerbations of asthma over the 32-week treatment period is expressed as the number of exacerbations per year. Analysis of the number of exacerbations performed using a negative binomial model with covariates of treatment group, baseline maintenance OCS therapy (OCS vs. no OCS), region, exacerbations in the year prior to the study (as an ordinal variable) and baseline % predicted FEV1, and with logarithm of time on treatment as an offset variable.|From randomization (Week 0) to Week 32 or if Early Withdrawal (EW) 4 weeks post last dose|ITT Population||Number of exacerbations per year|||Number
670962|NCT01691521|Primary|Number of Clinically Significant Exacerbations of Asthma Per Year|Clinically significant exacerbations of asthma are defined as worsening of asthma which required use of systemic corticosteroids (IV or oral steroid like prednisone, for at least 3 days or a single intramuscular (IM) corticosteroid (CS) dose is required. For maintenance of systemic corticosteroids, at least double the existing maintenance dose for at least 3 days was required) and/or hospitalization and/or emergency department (ED) visits. The frequency of clinically significant exacerbations of asthma over the 32-week treatment period is expressed as the number of exacerbations per year. Analysis of the number of exacerbations performed using a negative binomial model with covariates of treatment group, baseline maintenance OCS therapy (OCS vs. no OCS), region, exacerbations in the year prior to the study (as an ordinal variable) and baseline % predicted FEV1, and with logarithm of time on treatment as an offset variable.|From randomization (Week 0) to Week 32 or if Early Withdrawal (EW) 4 weeks post last dose|Modified Intent-to-Treat (ITT) Population: all participants who were randomized and who received at least one dose of trial medication. ‘Modified’ implies that, in cases where there is is a discrepancy between randomized and actual treatment the analysis used the actual treatment received by the participant rather than the randomized treatment.||Number of exacerbations per year|||Number
670963|NCT01691508|Secondary|Median Percentage Change From Baseline in Daily OCS Dose During Weeks 20 to 24 While Maintaining Asthma Control|BL dose was the prescribed optimized prednisone/prednisolone dose following the OCS Optimization Phase. MN dose was the mean of all daily prednisone/prednisolone doses during the MN Phase (weeks 20 to 24). The percent change of OCS dose during weeks 20 to 24 compared to BL dose was calculated as: 100 x (MN dose minus BL dose)/BL dose. Asthma control between weeks 20 and 24 was defined as no clinically significant exacerbation (worsening of asthma that required use of systemic corticosteroids or hospitalization and/or emergency department visits) during this period. For participants who withdrew from the study prior to the Maintenance Phase, and for participants with a lack of asthma control during the Maintenance Phase, a value equal to the minimum percent reduction in OCS use across all subjects was imputed for the analysis.|Baseline; Weeks 20 to 24|ITT Population||Percentage reduction in OCS dose||95% Confidence Interval|Median
670972|NCT01691482|Secondary|Percentage of Days for Which Participants Achieved a >=12% and 200 Milliliter (mL) Increase From Baseline in FEV1|FEV1 is the maximal amount of air that can be forcefully exhaled in one second. During each study period, pre- and post-bronchodilator spirometry for evaluation of FEV1 was performed at study visits as follows: approximately 1 hour after administration of the first bronchodilator (1 hour), and approximately 1 hour after administration of the second short-acting bronchodilator (2 hours).|up to 35 days|Efficacy Population||percentage of days||Standard Deviation|Mean
670964|NCT01691508|Secondary|Number of Participants Who Achieved a Total Reduction of OCS Dose During Weeks 20 to 24 While Maintaining Asthma Control|MN dose was the mean of all daily prednisone/prednisolone doses during the MN Phase (weeks 20 to 24). Asthma control between weeks 20 and 24 was defined as no clinically significant exacerbation (worsening of asthma that required use of systemic corticosteroids or hospitalization and/or emergency department visits) during this period. The number of participants who achieved a total reduction of OCS dose was based on the value of the MN dose. Total reduction implied no OCS use during the entire MN phase. Analysis was performed using a binary logistic regression model with terms for treatment group, region, duration of OCS use at BL (<5 years vs. >=5 years) and BL OCS dose.|Weeks 20 to 24|ITT Population||Participants|||Number
670965|NCT01691508|Secondary|Number of Participants Who Achieved a Reduction of Their Daily OCS Dose to <=5.0 mg During Weeks 20 to 24 While Maintaining Asthma Control|Maintenance (MN) dose was the mean of all daily prednisone/prednisolone doses during the MN Phase (weeks 20 to 24). Asthma control between weeks 20 and 24 was defined as no clinically significant exacerbation (worsening of asthma that required use of systemic corticosteroids or hospitalization and/or emergency department visits) during this period. Number of participants who achieved a reduction of their daily OCS dose to <=5.0 mg was based on the value of the MN dose. Analysis was performed using a binary logistic regression model with terms for treatment group, region, duration of OCS use at BL (<5 years vs. >=5 years) and BL OCS dose.|Weeks 20 to 24|ITT Population||Participants|||Number
670966|NCT01691508|Secondary|Number of Participants Who Achieved a Reduction of >=50% in Their Daily Oral Corticosteroid (OCS) Dose Compared With Baseline Dose, During Weeks 20 to 24 While Maintaining Asthma Control|Baseline (BL) dose was the prescribed optimized prednisone/prednisolone dose following the OCS Optimization Phase. Maintenance (MN) dose was the mean of all daily prednisone/prednisolone doses during the MN Phase (weeks 20 to 24). The percent reduction of OCS dose during weeks 20 to 24 compared to BL dose was calculated as: 100 x (BL dose minus MN dose)/BL dose. Asthma control between weeks 20 and 24 was defined as no clinically significant exacerbation (worsening of asthma that required use of systemic corticosteroids or hospitalization and/or emergency department visits) during this period. Analysis was performed using a binary logistic regression model with terms for treatment group, region, duration of OCS use at BL (<5 years vs. >=5 years) and BL OCS dose.|Baseline; Weeks 20 to 24|ITT Population||Participants|||Number
670967|NCT01691508|Primary|Number of Participants With the Indicated Percent Reduction From Baseline in Oral Corticosteroid (OCS) Dose During Weeks 20 to 24 While Maintaining Asthma Control|Baseline (BL) dose was the prescribed optimized prednisone/prednisolone dose following the OCS Optimization Phase. Maintenance (MN) dose was the mean of all daily prednisone/prednisolone doses during the MN Phase (weeks 20 to 24). The percent reduction of OCS dose during weeks 20 to 24 compared to BL dose was calculated as: 100 x (BL dose minus MN dose)/BL dose. Asthma control between weeks 20 and 24 was defined as no clinically significant exacerbation (worsening of asthma that required use of systemic corticosteroids or hospitalization and/or emergency department visits) during this period. The percent reduction of OCS was categorized as: 90 to 100%; 75 to <90%; 50 to <75%; >0 to <50%; no decrease in prednisone dose, or lack of asthma control, or withdrawal (WD) from treatment. Analysis was performed using a proportional odds model with terms for treatment group, region, duration of OCS use at BL (<5 years vs. >=5 years) and BL OCS dose.|Baseline; Weeks 20 to 24|Intent-to-Treat (ITT) Population: all participants who were randomized and who received at least one dose of study medication.||Participants|||Number
670968|NCT01691482|Secondary|Variability in Daily IC, Estimated by Half Range (i.e., Half the Difference Between Maximum and Minimum)|IC is the the total amount of air that can be drawn into the lungs after normal expiration. During each study period, pre- and post-bronchodilator spirometry for evaluation of IC was performed at study visits as follows: prior to administration of the first short-acting bronchodilator, approximately 1 hour after administration of the first bronchodilator (1 hour), and approximately 1 hour after administration of the second short-acting bronchodilator (2 hours). Variability in daily IC was measured as the fluctuation around the mean IC data collected from Day 1 to Day 10. Variability was measured by the coefficent of variation (CV) and the half range. The CV is the dispersion of the data around the mean, whereas the half range method is half the difference between the maximum and minimum IC values.|up to 10 days|Efficacy Population||Liters||Standard Deviation|Mean
670969|NCT01691482|Secondary|Variability in Daily Inspiratory Capacity (IC), Estimated by Coefficient of Variation|IC is the the total amount of air that can be drawn into the lungs after normal expiration. During each study period, pre- and post-bronchodilator spirometry for evaluation of IC was performed at study visits as follows: prior to administration of the first short-acting bronchodilator, approximately 1 hour after administration of the first bronchodilator (1 hour), and approximately 1 hour after administration of the second short-acting bronchodilator (2 hours). Variability in daily IC was measured as the fluctuation around the mean IC data collected from Day 1 to Day 10. Variability was measured by the coefficent of variation (CV) and the half range. The CV is the dispersion of the data around the mean, whereas the half range method is the difference between the maximum and minimum IC values.|up to 10 days|Efficacy Population||Liters||Standard Deviation|Mean
670970|NCT01691482|Primary|Variability in Daily FEV1, Estimated by Half Range (i.e., Half the Difference Between Maximum and Minimum Values)|FEV1 is the maximal amount of air that can be forcefully exhaled in one second. During each study period, pre- and post-bronchodilator spirometry for evaluation of FEV1 was performed at study visits as follows: prior to administration of the first short-acting bronchodilator, approximately 1 hour after administration of the first bronchodilator (1 hour), and approximately 1 hour after administration of the second short-acting bronchodilator (2 hours). Variability in daily FEV1 was measured as the fluctuation around the mean FEV1 data collected from Day 1 to Day 10. Variability was measured by the coefficient of variation (CV) and the half range. The CV is the dispersion of the data around the mean, whereas the half range method is half the difference between the maximum and minimum FEV1 values.|up to 10 days|Efficacy Population||Liters||Standard Error|Mean
670971|NCT01691482|Secondary|Percentage of Days for Which Participants Achieved a Threshold Increase From Baseline in FEV1 of 100 mL, 200 mL, and 250 mL|FEV1 is the maximal amount of air that can be forcefully exhaled in one second. During each study period, pre- and post-bronchodilator spirometry for evaluation of FEV1 was performed at study visits as follows: approximately 1 hour after administration of the first bronchodilator (1 hour), and approximately 1 hour after administration of the second short-acting bronchodilator (2 hours).|up to 35 days|Efficacy Population||percentage of days||Standard Deviation|Mean
670973|NCT01691482|Secondary|The Maximal Bronchodilator Response for the First Administered Agent|The maximal bronchodilator response for the first administered agent is defined as the FEV1 (the maximal amount of air that can be forcefully exhaled in one second) 1 hour post-dose of the first bronchodilator minus the pre-dose. The maximal bronchodilator response for the second agent is defined as the FEV1 1 hour post-dose of the second bronchodilator minus the FEV1 at 1 hour post-dose of the first bronchodilator. The maximal bronchodilator response for the combination is defined as the FEV1 (the maximal amount of air that can be forcefully exhaled in one second) at 1 hour post-administration of the second bronchodilator minus the corresponding pre-dose FEV1. Derived FEV1 response is FEV1 change from 0 hours (0H) for the first agent assessment (at 1 hour [1H]); change from 1H for the second agent assessment (at 2 hours [2H]); and change from 0H for the combination assessment (at 2H). Data were adjusted for FEV1, smoking status, and center.|up to 10 days|Efficacy Population||Liters||Standard Error|Least Squares Mean
670974|NCT01691482|Primary|Variability in Daily FEV1, Estimated by Coefficient of Variation|FEV1 is the maximal amount of air that can be forcefully exhaled in one second. During each study period, pre- and post-bronchodilator spirometry for evaluation of FEV1 was performed at study visits as follows: prior to administration of the first short-acting bronchodilator, approximately 1 hour after administration of the first bronchodilator (1 hour), and approximately 1 hour after administration of the second short-acting bronchodilator (2 hours). Variability in daily FEV1 was measured as the fluctuation around the mean FEV1 data collected from Day 1 to Day 10. Variability was measured by the coefficient of variation (CV) and the half range. The CV is the dispersion of the data around the mean, whereas the half range method is the difference between the maximum and minimum FEV1 values.|up to 10 days|Efficacy Population: participants in the Intent-to-Treat Population (all participants who were randomized and received at least one bronchodilator in the treatment period) who completed pre- and post- bronchodilator assessments for at least 17 visits, with no more than 3 consecutive missing days||Liters||Standard Error|Mean
670975|NCT01691339|Other Pre-specified|Number of Participants With Influenza Antibody Titers of <1:10 Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine|Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay to determine pre-vaccination and post-vaccination titers of <1:10.|Day 0 (pre-vaccination) and Day 21 post-vaccination|Antibody responses to the influenza vaccine antigens were assessed in the Per-Protocol Analysis Set.||Participants|||Number
670976|NCT01691339|Other Pre-specified|Number of Adult Participants With Seroconversion to Influenza Virus Vaccine Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine|Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay. Seroconversion was defined as either a pre-vaccination titer < 10 (1/dil) and a post-vaccination titer ≥ 40 (1/dil), or a pre-vaccination titer ≥ 10 (1/dil) and a ≥ 4-fold increase in post-vaccination titer.|Day 0 (pre-vaccination) and Day 21 post-vaccination|Seroconversion to the influenza virus vaccine antigens was assessed in the Per-Protocol Analysis Set.||Participants|||Number
670977|NCT01691339|Other Pre-specified|Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine|Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay. Seroprotection was defined as a pre-vaccination or a post-vaccination titer ≥ 40 (l/dil).|Day 0 (pre-vaccination) and Day 21 post-vaccination|Seroprotection against influenza vaccine antigens were assessed in the Per-Protocol Analysis Set.||Participants|||Number
670978|NCT01691339|Other Pre-specified|Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine|Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay.|Day 0 (pre-vaccination) up to Day 21 post-vaccination|Geometric mean titers against the influenza virus antigens were assessed in the Per-Protocol Analysis Set.||Titers||95% Confidence Interval|Geometric Mean
670979|NCT01691339|Primary|Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine|"Solicited injection site: Pain, Erythema, Swelling, Induration, and Ecchymosis; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering.
Grade 3 injection site: Pain - Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis - >100 mm. Grade 3 systemic reactions: Fever ≥39.0°C; Headache, Malaise, Myalgia, and Shivering - significant, prevents daily activity."|Day 0 up to Day 7 post-vaccination|Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set.||Participants|||Number
670980|NCT01691326|Other Pre-specified|Geometric Mean Titer Ratios (GMTRs) of Antibodies to Influenza Virus Antigens Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation).|Influenza virus antibodies were measured using a HAI assay. Geometric mean titer ratio is the geometric mean of the individual post-vaccination / pre-vaccination titer of antibodies to the influenza virus antigens|Day 0 (pre-vaccination) and Day 28 after final vaccination|Geometric mean titer ratios against the influenza virus antigens were assessed in the Per-protocol Analysis Set.||Ratio||95% Confidence Interval|Geometric Mean
670981|NCT01691326|Other Pre-specified|Number of Participants With Seroconversion Against Influenza Virus Antigens Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation)|Influenza virus antibodies were measured using a HAI assay. Seroconversion was defined as a pre-vaccination titer <10 (1/dilution) and a post-vaccination titer ≥40 (1/dilution), or a pre-vaccination titer ≥10 (1/dilution) and ≥4-fold increase in titer 28 days after final vaccination.|Day 28 after final vaccination|Seroconversion against the influenza virus antigens were assessed in the Per-protocol Analysis Set.||Participants|||Number
670982|NCT01691326|Other Pre-specified|Number of Participants With Seroprotection Before and Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation)|Influenza virus antibodies were measured using a HAI assay. Seroprotection was defined as a titer ≥40 (1/dilution).|Day 0 (pre-vaccination) and Day 28 after final vaccination|Seroprotection against the influenza virus antigens were assessed in the Per-protocol Analysis Set.||Participants|||Number
670983|NCT01691326|Other Pre-specified|Geometric Mean Titers of Antibodies to Influenza Antigens Before and Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation).|The influenza virus antibodies were measured using a hemagglutination inhibition (HAI) assay.|Day 0 (pre-vaccination) and Day 28 after final vaccination|Geometric mean titers of antibodies against the influenza virus antigens were assessed in the Per-protocol Analysis Set.||Titers||95% Confidence Interval|Geometric Mean
670984|NCT01691326|Primary|Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation)|"Solicited injection site reactions (Age 6 to < 24 Months): Tenderness, Erythema and Swelling. Solicited systemic reactions: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of appetite, and Irritability.
Grade 3: Tenderness, Cries when injected limb is moved; Erythema and Swelling, ≥ 50 mm; Fever, >103.1°F; Vomiting, ≥6 episodes/24 hours; Abnormal crying, >3 hours; Drowsiness, Sleeping most of the time; Loss of appetite, Refuses ≥3 feeds/meals or most feeds/meals; Irritability, Inconsolable.
Solicited injection site reactions (Age 24 Months to < 9 Years): Pain, Erythema, and Swelling. Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia.
Grade 3: Pain, Incapacitating, unable to perform usual activities; Redness and Swelling, ≥ 50 mm; Fever: ≥102.1°F; Headache, Malaise, and Myalgia, Significant, prevents daily activity."|Day 0 up to Day 7 post-vaccination|Solicited injection site reactions and systemic reactions were assessed using the Safety Analysis Set, which includes all persons who received at least one dose of study vaccine.||Participants|||Number
670985|NCT01691313|Primary|Conversion to Sinus Rhythm|proportion of subjects who convert to sinus rhythm through 24 hours after start of study drug|baseline through 24 hours|||participants|||Number
670986|NCT01691313|Primary|Conversion to Sinus Rhythm|proportion of subjects who convert to sinus rhythm through 4 hours after start of study drug|baseline through 4 hours|||participants|||Number
670987|NCT01691248|Secondary|Percentage of Participants With Occurrence of CDAD From Start of Study Treatment up to Day 70 of Study.|CDAD is defined as follows: Diarrhea: (change in bowel habits with >3 unformed bowel movements in a 24 hour period) and the presence of either toxin A and/or B (or their respective genes, tcdA and/or tcdB) of C. difficile in the stool determined by C. difficile toxin assay. Wald 95% Confidence Intervals (CI) are presented.|Up to Day 70 of study|mITT consisting of all randomized participants undergoing HSCT who received at least 1 dose of study drug.||Percentage of participants||95% Confidence Interval|Number
670988|NCT01691248|Secondary|Percentage of Participants With Occurrence of CDAD From Start of Study Treatment up to 60 Days Post-treatment.|CDAD is defined as follows: Diarrhea: (change in bowel habits with >3 unformed bowel movements in a 24 hour period) and the presence of either toxin A and/or B (or their respective genes, tcdA and/or tcdB) of C. difficile in the stool determined by C. difficile toxin assay. Wald 95% Confidence Intervals (CI) are presented.|Up to 60 days post-treatment|mITT consisting of all randomized participants undergoing HSCT who received at least 1 dose of study drug.||Percentage of participants||95% Confidence Interval|Number
670989|NCT01691248|Primary|Percentage of Participants With Occurrence of CDAD From Start of Study Treatment up to 30 Days Post-treatment Follow-up.|CDAD is defined as follows: Diarrhea: (change in bowel habits with >3 unformed bowel movements in a 24 hour period) and the presence of either toxin A and/or B (or their respective genes, tcdA and/or tcdB) of C. difficile in the stool determined by C. difficile toxin assay. Wald 95% Confidence Intervals (CI) are presented.|Up to 30 days post-treatment|mITT consisting of all randomized participants undergoing HSCT who received at least 1 dose of study drug.||Percentage of participants||95% Confidence Interval|Number
670990|NCT01691092|Primary|Change in Glutamate Levels at Baseline and After Ketamine Administration as Confirmed by Positron Emission Tomography (PET) Imaging|PET imaging obtained in healthy and Major Depressive Disorder (MDD) subjects. Glutamate levels determined by radiotracer uptake in PET images.|1st scan: 90 minute baseline scan; 2nd scan: 90 minutes, ketamine administration at start of scan; scan 3: 90 minute scan 24 hours post ketamine|13 healthy (6 males, 7 females) and 14 MDD non-smokers (4 males, 10 females) Mean age: 33.5 ± 13.2 yrs reasons for discrepancy (participant flow module): some data was not able to be analyzed due to elevated metabolites; some subject did not tolerate ketamine and had to be pulled out of scanner so we could not obtain data.||percentage reduction||Standard Deviation|Mean
670991|NCT01691014|Secondary|Health Assessment Questionnaire (HAQ) Score After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab at Baseline, Month 3, 6 and 12|HAQ was a self-reported, valid assessment of functional disability in rheumatoid arthritis based on ability of participants to perform daily activities. HAQ total score range: 0 (normal functioning) to 3 (worst functioning), where higher score indicates worse functioning.|Baseline, Month 3, 6, 12|"EAS included all participants that provided at least 1 post-baseline assessment. Here, n signifies number of participants evaluable for this outcome measure at the specified time points."||units on a scale||Standard Deviation|Mean
670992|NCT01691014|Secondary|Disease Activity Score Based on 28-Joints Count (DAS28) After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab at Month 3, 6 and 12|DAS28-4 was calculated from swollen joint count (SJC) and tender joint count (TJC) using 28 joint count, C-reactive protein (CRP) in milligram per liter (mg/L) and participant global assessment (PGA) of disease activity (participant rated arthritis activity assessment with total score ranging from 0 [good condition] to 10 [worst condition]; higher score indicates worse condition). DAS28-4 total score range: 0 (no disease activity) to 9.4 (maximum disease activity), higher score indicates more disease activity. DAS28-4 (CRP) less than or equal to (<=) 3.2 implied low disease activity and greater than (>) 3.2 to 5.1 implied moderate to high disease activity.|Month 3, 6, 12|EAS included all participants that provided at least 1 post-baseline assessment. Here,”n” signifies number of participants evaluable at the specified time points for this outcome measure.||units on a scale||Standard Deviation|Mean
670993|NCT01691014|Secondary|Correlation Between the Formation of Anti-drug Antibodies to Adalimumab, Certolizumab, Etanercept or Infliximab and Concomitant Methotrexate Treatment|Association between formation of anti-drug antibodies to Adalimumab, Certolizumab, Etanercept and Infliximab and concomitant Methotrexate treatment (weekly dose of 7.5 milligram) was to be analyzed.|Month 12|Data was not collected since this outcome measure was not analyzed due to premature termination of the study.|||||
670994|NCT01691014|Secondary|Number of Participants With Anti-drug Antibodies Levels 3 and 12 Months After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab|Anti-drug antibodies to Adalimumab, Certolizumab, Etanercept and Infliximab were to be measured in serum samples using a validated commercially available cell-based reporter-gene assay.|Month 3, 12|Data was not collected since this outcome measure was not analyzed due to premature termination of the study.|||||
671268|NCT01687244|Secondary|Incidence of Cystectomy in All Patients|This secondary objective measures the incidence of cystectomy at 360 Days for the Efficacy Analysis Set.|360 Days|The data are presented as the number of patients per dose group having a cystectomy during the 360 days of the study.||Participants|||Count of Participants
670995|NCT01691014|Secondary|Correlation Between Formation of Antibodies to Adalimumab, Certolizumab, Etanercept or Infliximab 6 Months After Initiation of Treatment and Cessation of Therapy Between Month 6 and 12 Visits|Association between formation of antibodies to Adalimumab, Certolizumab, Etanercept and Infliximab and cessation of therapy was to be analyzed. Cessation of therapy between month 6 and month 12 was the time to withdrawal from study due to either adverse events or lack of effect between the 6 month visit and the 12 month visit.|Month 6, 12|Data was not collected since this outcome measure was not analyzed due to premature termination of the study.|||||
670996|NCT01691014|Secondary|Correlation Between Formation of Antibodies to Adalimumab, Certolizumab, Etanercept or Infliximab 6 Months After Initiation of Treatment and Health Assessment Questionnaire (HAQ) 12 Months After Initiation of Treatment|Association between formation of antibodies to Adalimumab, Certolizumab, Etanercept, Infliximab and HAQ scores was to be analyzed using Pearson and Spearman correlations across and within each of the four treatment groups. HAQ was a self-reported, valid assessment of functional disability in rheumatoid arthritis based on ability of participants to perform daily activities. HAQ total score range: 0 (normal functioning) to 3 (worst functioning), where higher score indicates worse functioning.|Month 6, 12|Data was not collected since this outcome measure was not analyzed due to premature termination of the study.|||||
670997|NCT01691014|Secondary|Correlation Between Formation of Antibodies to Adalimumab, Certolizumab, Etanercept or Infliximab 6 Months After Initiation of Treatment and Disease Activity Score 28 (DAS28) 12 Months After Initiation of Treatment|Association between formation of antibodies to Adalimumab, Certolizumab, Etanercept, Infliximab and DAS28 was to be analyzed using Pearson and Spearman correlations across and within each of the four treatment groups. DAS28-4 was calculated from swollen joint count (SJC) and tender joint count (TJC) using 28 joint count, C-reactive protein (CRP) in milligram per liter (mg/L) and participant global assessment (PGA) of disease activity (participant rated arthritis activity assessment with total score ranging from 0 [good condition] to 10 [worst condition]; higher score indicates worse condition). DAS28-4 total score range: 0 (no disease activity) to 9.4 (maximum disease activity), higher score indicates more disease activity.|Month 6, 12|Data was not collected since this outcome measure was not analyzed due to premature termination of the study.|||||
670998|NCT01691014|Primary|Number of Participants With Presence of Active Drugs in Serum 6 Months After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab|Presence of active drugs in serum 6 months after treatment with Adalimumab, Certolizumab, Etanercept and Infliximab were to be measured in serum samples using a validated commercially available cell-based reporter-gene assay.|Month 6|Data was not collected since this outcome measure was not analyzed due to premature termination of the study.|||||
670999|NCT01691014|Primary|Number of Participants With Anti-drug Antibodies Formation Levels 6 Months After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab|Anti-drug antibodies to Adalimumab, Certolizumab, Etanercept and Infliximab were to be measured in serum samples using a validated commercially available cell-based reporter-gene assay.|Month 6|Data was not collected since this outcome measure was not analyzed due to premature termination of the study.|||||
671000|NCT01690923|Primary|AHI on Nasal Mask and Pillows Mask|AHI (measure of sleep-disordered breathing severity) on nasal mask and nasal pillows measured as average events/hour|7 days|||events/hour||Standard Deviation|Mean
671001|NCT01690923|Secondary|Usability|Participant's feedback of performance of the study devices. Likert Scale 0-10 (0=very bad, 10=very good)|After 7 days of use|||Units on a scale||Inter-Quartile Range|Median
671002|NCT01690663|Secondary|The Secondary Outcome Variable is Post Operative Motor Block Duration|This is defined as time from the completion of the block to the time when patient is able to move his or her forearm and/or hands. The patients were evaluated on different days to capture the exact end time, which was the initiation of supplemental analgesia medication. We intentionally contacted patients several times to capture the time as early as possible to minimize recall bias.|days 1, 2, and day 7|||hours||Inter-Quartile Range|Mean
671003|NCT01690663|Primary|Primary Outcome Variable is Post Operative Sensory Block Duration|This is defined as time from the completion of the block to the initiation of supplemental analgesia medications after hospital discharge. The patients were evaluated on different days to capture the exact end time, which was the initiation of supplemental analgesia medication. We intentionally contacted patients several times to capture the time as early as possible to minimize recall bias.|days 1, 2, and day 7|||hours||Inter-Quartile Range|Mean
671004|NCT01690546|Secondary|Number of Participants That Self Reported Illicit Drug Use|Participants reported on any illicit drug use to include Cocaine marijuana opiates|4 weeks|||participants|||Number
671005|NCT01690546|Secondary|Use of Ancillary Medications.|Number of participants that took ancillary medication|baseline to week 1|||participants|||Number
671006|NCT01690546|Secondary|Percentage of Participants With Adherence to Medication (Naltrexone)|Participant who took Naltrexone as prescribed.|Day 1 to Day 8 (+/- 2 days)|||percentage of participants|||Number
671007|NCT01690546|Secondary|Percentage of Participants Who Adhered to Study Visits.||baseline to end of study (approximately 40 days)|||percentage of participants|||Number
671008|NCT01690546|Secondary|Satisfaction With Treatment, Measured by a Treatment Satisfaction Questionnaire|"Questionnaire consisted of 3 questions.
Were you satisfied with the treatment (range 1-5): Completely satisfied (1) to completely dissatisfied (5).
Were you satisfied with withdrawal treatment (range 1-5): Minimal withdrawal (1) to worse than ever (5).
Did the medication help (range 1-5): Helped a lot (1) to No it did not help (5).
Lower scores represent greater satisfaction."|Day 9|||units on a scale||Standard Deviation|Mean
671009|NCT01690546|Secondary|Illicit Drug Use, Measured by Urine Drug Testing|number of participants that tested positive for marijuana, cocaine, and opiates.|4 weeks|||participants|||Number
671010|NCT01690546|Secondary|Craving|Craving, assessed with a 100-point Visual Analog Scale (VAS), ranging from ‘not at all’ (0) to ‘more than ever’ (100). The higher the score the higher the craving.|4 weeks|||units on a scale||Standard Deviation|Mean
671011|NCT01690546|Secondary|Withdrawal Intensity as Measured by the Subjective Opiate Withdrawal Scale (SOWS)|"After the initial titration period for opioid withdrawal (of up to 8 days), patients will receive the Vivitrol injection. Then, we will follow patients for retention out to 4 weeks and record the total time they remained in treatment.
SOWS contains 16 symptoms whose intensity the patient rates on a scale of 0 (not at all) to 4 (extremely). Total score range is 0 - 64; the higher the score the more withdrawal symptoms."|4 weeks|||units on a scale||Standard Deviation|Mean
671012|NCT01690546|Secondary|Withdrawal Intensity as Measured by the Clinical Opiate Withdrawal Scale (COWS)|"After the initial titration period for opioid withdrawal (of up to 8 days), patients will receive the Vivitrol injection. Then, we will follow patients for retention out to 4 weeks and record the total time they remained in treatment.
COWS rates eleven common opiate withdrawal signs or symptoms. The summed scores ranged from 0-48, with 5-12 = mild; 13-24 = moderate; 25-36 = moderately severe; more than 36 = severe withdrawal."|4 weeks|All participants who received the Extended Release Injectable NTX||units on a scale||Standard Deviation|Mean
671013|NCT01690546|Primary|Retention in Treatment|After the initial titration period for opioid withdrawal (of up to 8 days), patients will receive the Vivitrol injection. Then, we will follow patients for retention out to 4 weeks.|4 weeks|All participants who received the Extended Release Injectable NTX||participants|||Number
671014|NCT01690299|Secondary|Psoriasis Flare/Rebound|Psoriasis flare is an AE and represents an atypical or unusual worsening of disease during treatment. It is defined as a sudden intensification of psoriasis requiring medical intervention or a diagnosis of new generalized erythrodermic, inflammatory, or pustular psoriasis. Rebound is an AE and is defined as a severe and sudden worsening of disease that occurs after treatment has been discontinued. This exacerbation is characterized by a PASI ≥125% of baseline or a new generalized pustular, erythrodermic, or more inflammatory psoriasis after stopping therapy. PASI ≥125% of baseline score at any visit after the last dose date for those who discontinued within the phase.|From the first dose of apremilast (either Week 0 or Week 16 for participants originally randomized to placebo or etanercept who were switched at Week 16) until 28 days after the last dose of apremilast.|Safety population includes all participants who were randomized and received at least one dose of study drug.||participants|||Number
671015|NCT01690299|Secondary|Psoriasis Flare/Rebound|Psoriasis flare is an AE and represents an atypical or unusual worsening of disease during treatment. It is defined as a sudden intensification of psoriasis requiring medical intervention or a diagnosis of new generalized erythrodermic, inflammatory, or pustular psoriasis. Rebound is an AE and is defined as a severe and sudden worsening of disease that occurs after treatment has been discontinued. This exacerbation is characterized by a PASI ≥125% of baseline or a new generalized pustular, erythrodermic, or more inflammatory psoriasis after stopping therapy.|Week 0 to Week 16; Placebo controlled phase|Safety population includes all participants who were randomized and received at least one dose of study drug.||participants|||Number
671016|NCT01690299|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Apremilast-exposure Period|A TEAE in the apremilast-exposure phase is an AE with a start date on or after the date of the first dose of study drug and no later than 28 days after the last dose of study drug. An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen during the study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject’s health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE. A serious AE (SAE) is any untoward AE that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize or may require intervention to prevent one of the outcomes listed above.|From the first dose of apremilast (either Week 0 for participants originally randomized to apremilast or Week 16 for those originally randomized to placebo or etanercept who were switched to apremilast at week 16) until 28 days after last apremilast dose|All participants who received apremilast at any time during the study.||participants|||Number
671017|NCT01690299|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Placebo-Controlled Phase|A TEAE is an AE with a start date on or after the date of the first dose of study drug and no later than 28 days after the last dose of study drug for participants who discontinued early. An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen during the study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the patient's health, including laboratory test values, regardless of etiology. Any worsening (ie, clinically significant adverse change in frequency or intensity of a preexisting condition) should be considered an AE. A serious AE (SAE) is any untoward AE that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize or may require intervention to prevent one of the outcomes above.|Week 0 to Week 16; mean duration of exposure was 14.90 weeks for placebo group, 15.13 weeks for apremilast group and 15.87 weeks for Etanercept group|Safety population includes all participants who were randomized and received at least one dose of study drug.||participants|||Number
671018|NCT01690299|Secondary|Percentage of Participants Who Achieved a Lattice System Physician’s Global Assessment (LS-PGA) Score of Clear (0) or Almost Clear at Week 16 in Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16|The Lattice System Physician’s Global Assessment is a global assessment performed by the investigator of psoriasis severity. Integrating ranges of BSA involvement with assessments of overall plaque severity (using a 4 point scale from none to marked for the signs of plaque elevation, erythema and scale), the LS-PGA produces an overall assessment of psoriasis severity on an 8-point scale, ranging from clear to very severe. To determine the final score, the lattice portion is governed by the BSA and among the plaque qualities, weights plaque elevation as most important, erythema next, and scale least.|Baseline to Week 16|mITT population consisted of all participants who were randomized and received at least one dose of study drug and had both a baseline PASI and at least one post-treatment PASI evaluation. Missing data imputation: LOCF.||percentage of participants|||Number
671041|NCT01690117|Secondary|Change From Baseline in Strength of Reaction of Caregivers to Problem Behavior on a German Version of the Reaction Subscale of the Revised Memory and Behavior Problem Checklist (RMBPC) - (5-point Scale) at Month 9|RMBPC reaction subscale is a validated self-reported instrument assessing the strength of reaction of caregivers to problem behavior of cognitively impaired persons over the last week time period. Possible scores range from 0 (no reaction) and 96 (extremely strong reaction). Change = (Month 9 Score - Baseline score)|baseline and month 9|The RMBPC reaction subscale was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.||units on a scale||Standard Deviation|Mean
671019|NCT01690299|Secondary|Change From Baseline in the Mental Component Summary (MCS) Score of the Medical Outcome Study Short Form 36-item (SF-36) Health Survey Version 2.0 in Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16|The SF-36 is a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Scores from the 8 scales were transformed to the norm-based scores using weights from U.S. general population to have a mean of 50 and variance = 10, with higher scores indicating better health. From these 8 scale, two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS), both having the same mean of 50 and variance = 10 as noted for the individual scales for the U.S. general population, and with higher scores indicating better health. For MCS, change from baseline was calculated, where change = visit value − baseline value.|Baseline to Week 16|mITT population consisted of all participants who were randomized and received at least one dose of study drug and had both a baseline PASI and at least one post-treatment PASI evaluation. Missing data imputation: LOCF.||units on a scale||95% Confidence Interval|Least Squares Mean
671020|NCT01690299|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score In Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16|"DLQI is a simple, compact, and practical questionnaire for use in a dermatology clinical setting to assess limitations related to the impact of skin disease. The instrument contains ten items dealing with the participant's skin. With the exception of Item Number 7, the participant responds on a four-point scale, ranging from Very Much (score 3) to Not at All or Not relevant (score 0). Item Number 7 is a multi-part item, the first part of which ascertains whether the participant's skin prevented them from working or studying (Yes or No, scores 3 or 0 respectively), and if No, then the participant is asked how much of a problem the skin has been at work or study over the past week, with response alternatives being A lot, A little, or Not at all (scores 2, 1, or 0 respectively). The DLQI total score is derived by summing all item scores, which has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best."|Baseline to Week 16|mITT population consisted of all participants who were randomized and received at least one dose of study drug and had both a baseline PASI and at least one post-treatment PASI evaluation. Missing data imputation: LOCF.||units on a scale||95% Confidence Interval|Least Squares Mean
671021|NCT01690299|Secondary|Percentage of Participants Who Achieved a 50% Improvement (Response) in the Psoriasis Area Severity Index (PASI-50) for Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16|PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score at Week 16. The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The PASI score was set to missing if any severity score or degree of involvement was missing.|Baseline to Week 16|mITT population consisted of all participants who were randomized and received at least one dose of study drug and had both a baseline PASI and at least one post-treatment PASI evaluation. Missing data imputation: Last observation carried forward (LOCF).||percentage of participants|||Number
671022|NCT01690299|Secondary|Percent Change From Baseline in the Affected Body Surface Area (BSA) for Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16|"BSA is a measurement of involved skin. The overall BSA affected by psoriasis was estimated based on the palm area of the participant's hand (entire palmar surface or handprint including the fingers), which equates to approximately 1% of total body surface area. BSA percent change from baseline was determined at each visit of the study, and is calculated as 100*(post-baseline BSA - baseline BSA) / baseline BSA."|Baseline to Week 16|mITT population consisted of all participants who were randomized and received at least one dose of study drug and had both a baseline PASI and at least one post-treatment PASI evaluation. Missing data imputation: LOCF.||percent change||95% Confidence Interval|Least Squares Mean
671023|NCT01690299|Secondary|Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of Clear (0) or Almost Clear (1) With at Least 2 Points Reduction for Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16|The sPGA is an assessment by the Investigator of the overall disease severity at the time of evaluation. The sPGA is a 5-point scale ranging from 0 (clear) to 4 (severe), incorporating an assessment of the severity of the three primary signs of the disease: erythema, scaling and plaque elevation. When making the assessment of overall severity, the Investigator should factor in areas that have already been cleared (ie, have scores of 0) and not just evaluate remaining lesions for severity, ie, the severity of each sign is averaged across all areas of involvement, including cleared lesions. In the event of different severities across disease signs, the sign that is the predominant feature of the disease should be used to help determine the sPGA score.|Baseline and Week 16|mITT population consisted of all participants who were randomized and received at least one dose of study drug and had both a baseline PASI and at least one post-treatment PASI evaluation. Missing data imputation: Last observation carried forward (LOCF).||percentage of participants|||Number
671042|NCT01690117|Secondary|Change From Baseline in Strength of Reaction of Caregivers to Problem Behavior on a German Version of the Reaction Subscale of the Revised Memory and Behavior Problem Checklist (RMBPC) - (5-point Scale) at Month 6|RMBPC reaction subscale is a validated self-reported instrument assessing the strength of reaction of caregivers to problem behavior of cognitively impaired persons over the last week time period. Possible scores range from 0 (no reaction) and 96 (extremely strong reaction). Change = (Month 6 Score - Baseline score)|baseline and month 6|The RMBPC reaction subscale was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.||units on a scale||Standard Deviation|Mean
671341|NCT01686451|Other Pre-specified|Comparison of Safety Laboratory Testing (Cr) Between Simvastatin- and Xuezhikang-group|Fasting blood samples were collected at weeks 0 (randomization) and 4 (end of study) for clinical chemistry.|Measured at baseline and week 4|||mmol/L||Standard Deviation|Mean
671024|NCT01690299|Secondary|Percentage of Participants Who Achieved a 75% Improvement (Response) in the Psoriasis Area and Severity Index (PASI) for the Comparison Between Etanercept 50mg SC QW and Placebo at Week 16|PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The PASI score was set to missing if any severity score or degree of involvement was missing.|Baseline and Week 16|mITT population consisted of all participants who were re-randomized and received at least one dose of study drug and had both a baseline PASI and at least one post-treatment PASI evaluation. Missing data imputation: Last observation carried forward (LOCF).||percentage of participants|||Number
671025|NCT01690299|Primary|Percentage of Participants Who Achieved a 75% Improvement (Response) in the Psoriasis Area Severity Index (PASI-75) for the Comparison Between Apremilast and Placebo at Week 16 From Baseline|PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The PASI score was set to missing if any severity score or degree of involvement was missing.|Baseline to Week 16|The modified intent-to-treat (mITT) population consisted of all participants who were randomized and received at least one dose of study drug and had both a baseline PASI and at least one post-treatment PASI evaluation. Missing data imputation: Last observation carried forward (LOCF).||Percentage of participants|||Number
671026|NCT01690273|Secondary|Chest Expansion|Chest expansion was measured with a tape in centimeters between inspiration and breathing exhaling. Highest score means better chest expansion. Data are expressed by means and standard deviation.|Baseline and 16 Weeks|||Centimeters||Standard Deviation|Mean
671027|NCT01690273|Secondary|Finger Floor Distance|Distance between third finger of the hand and the floor while in lumbar flexion. It was measured with a tape in centimeters. Highest score means better torso flexion mobility. Data are expressed by means and standard deviation|Baseline and 16 Weeks|||Centimeters||Standard Deviation|Mean
671028|NCT01690273|Secondary|Tragus-coronoid Distance|lateral flexion of the head (tragus-coronoid distance) was measured with a tape in centimeters. Highest score means better lateral flexion mobility of the head.Data are expressed by means and standard deviation|Baseline and 16 Weeks|||Centimeters||Standard Deviation|Mean
671029|NCT01690273|Secondary|Chin-coronoid Distance|lateral rotation of the head (chin-coronoid distance) was measured with a tape in centimeters. Highest score means better lateral rotation mobility. Data are expressed by means and standard deviation|Baseline and 16 Weeks|||Centimeters||Standard Deviation|Mean
671030|NCT01690273|Secondary|MASES|Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) score varying from 0 to 13. Where 0 is no painful point reported and 13 is all tender points reported as painful. Data are expressed by means and standard deviation|Baseline and 16 Weeks|||Number of painful tender points||Standard Deviation|Mean
671031|NCT01690273|Secondary|Short Form-12 (MCS)|Quality of life was analyzed in a mental component score varying from 0 (lowest level of health) to 100 (highest level of health). Data are expressed by mean and SD.|Baseline and 16 Weeks|||units on a scale||Standard Deviation|Mean
671032|NCT01690273|Secondary|Short Form-12 (PCS)|Quality of life was analyzed in a physical component score varying from 0 (lowest level of health) to 100 (highest level of health) scale. Data are expressed by mean and SD.|Baseline and 16 Weeks|||units on a scale||Standard Deviation|Mean
671033|NCT01690273|Secondary|Stiffness Scale|Stiffness was measured by an VAS varying from 0 to 10. Higher scores means worst stiffness. Data are expressed by mean and SD.|Baseline and 16 Weeks|||units on a scale||Standard Deviation|Mean
671034|NCT01690273|Secondary|Pain Scale|Pain was evaluated in a visual analogue scale (VAS) from 0 to 10. higher scores means much pain. Data was expressed by means and standard deviation.|Baseline and 16 Weeks|||units on a scale||Standard Deviation|Mean
671035|NCT01690273|Secondary|Thoracolumbar Mobility|Thoracolumbar rotation Pavelka. Measured with a tape in centimeters. Higher number means better thoracolumbar rotation|Baseline and 16 Weeks|||Centimeters||Standard Deviation|Mean
671036|NCT01690273|Primary|Global Evaluation Self Reported|Bath Ankylosing Spondylitis Global is a self reported global score varying from 0 to 10. Higher scores means worst health evaluation. Expressed by means and standard deviation.|Baseline and 16 Weeks|||units on a scale||Standard Deviation|Median
671037|NCT01690273|Primary|Ankylosing Spondylitis Disease Activity Scale -Disease Activity|Scores vary from 0 to 10, and higher than 4 scores are indicative of disease activity. Data are expressed by means and SD|Baseline and 16 Weeks|||units on a scale||Standard Deviation|Mean
671038|NCT01690273|Primary|Disease Activity Index|BASDAI - Bath ankylosing spondylitis disease activity index. Scale from 0 to 6. Higher scores means worst disease activity. Numbers are expressed in average (SD)|Baseline and 16 Weeks|||units on a scale||Standard Deviation|Mean
671039|NCT01690273|Primary|Mobility Index|Bath ankylosing spondylitis motion index. A mean of five mobility measures committed by Ankylosing Spondylitis disease. Higher results means higher limitations in mobility (units of measure from 0 to 10)|Baseline and 16 weeks|||units on a scale from 0 to 10||Standard Deviation|Mean
671040|NCT01690273|Primary|FUNCTIONAL INDEX|BASFI - Bath ankylosing spondylitis functional index. A scale from 0 to 10 (lower scores means better functional capacity), results are measured by mean and standard deviation.|Baseline and 16 Weeks|||units on a scale||Standard Deviation|Mean
675623|NCT01637090|Primary|Efficacy of Treatment|Determine the efficacy of everolimus in the treatment of CTCL as overall response rate (ORR)|12 months after beginning treatment|Study was pre-maturely terminated. No data were collected for the Outcome Measure|||||
671043|NCT01690117|Secondary|Change From Baseline in Frequency of Problem Behavior on a German Version of the Frequency Subscale of the Revised Memory and Behavior Problem Checklist (RMBPC) - (5-point Scale) at Month 9|The frequency subscale of the RMBPC is a validated proxy-reported instrument assessing the frequency of problem behavior of cognitively impaired persons over the last week time period. Possible scores range from 0 (never occured) and 96 (extremely often). Change = (Month 9 Score - Baseline score)|baseline and month 9|The RMBPC - frequency subscale was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.||units on a scale||Standard Deviation|Mean
671044|NCT01690117|Secondary|Change From Baseline in Frequency of Problem Behavior on a German Version of the Frequency Subscale of the Revised Memory and Behavior Problem Checklist (RMBPC) - (5-point Scale) at Month 6|RMBPC frequency subscale is a validated, proxy-reported instrument assessing the frequency of problem behavior of cognitively impaired persons over the last week time period. Possible scores range from 0 (never occured) and 96 (extremely often). Change = (Month 6 Score - Baseline score)|baseline and month 6|The RMBPC - frequency subscale was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.||units on a scale||Standard Deviation|Mean
671045|NCT01690117|Secondary|Change From Baseline in Physical Quality of Life on the German Version of the Physical Component Summary of the General Health Questionaire Short Form 12 (SF-12) at Month 9|SF-12 is a validated, self-reported instrument assessing psychological and physical quality of live of the caregivers over the last four weeks time period. Possible scores range from 0 (lowest level of health) and 100 (highest level of health). Change = (Month 9 Score - Baseline score)|baseline and month 9|The SF-12 - physical component was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.||units on a scale||Standard Deviation|Mean
671046|NCT01690117|Secondary|Change From Baseline in Physical Quality of Life on the German Version of the Physical Component Summary of the General Health Questionaire Short Form 12 (SF-12) at Month 6|SF-12 is a validated, self-reported instrument assessing psychological and physical quality of live of the caregivers over the last four weeks time period. Possible scores range from 0 (lowest level of health) and 100 (highest level of health). Change = (Month 6 Score - Baseline score)|baseline and month 6|The SF-12 -mental component was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.||units on a scale||Standard Deviation|Mean
671047|NCT01690117|Secondary|Change From Baseline in Psychological Quality of Life on the German Version of the Mental Component Summary of the General Health Questionaire Short Form 12 (SF-12) at Month 9|SF-12 is a validated, self-reported instrument assessing psychological and physical quality of live of the caregivers over the last four weeks time period. Possible scores range from 0 (lowest level of health) and 100 (highest level of health). Change = (Month 9 Score - Baseline score)|baseline and month 9|The SF-12 -mental component was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.||units on a scale||Standard Deviation|Mean
671048|NCT01690117|Secondary|Change From Baseline in Psychological Quality of Life on the German Version of the Mental Component Summary of the General Health Questionaire Short Form 12 (SF-12) at Month 6|SF-12 - mental component is a validated, self-reported instrument assessing psychological quality of live of the caregivers over the last four weeks time period. Possible scores range from 0 (lowest level of health) and 100 (highest level of health). Change = (Month 6 Score - Baseline score)|baseline and month 6|The SF-12 -mental component was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.||units on a scale||Standard Deviation|Mean
671049|NCT01690117|Secondary|Change From Baseline in Social Support on the ENRICHED-Social-Support-Instrument (ESSI) (5-point Scale) at Month 9|ESSI is a validated, self-reported instrument assessing perceived social support of the caregivers over a undefined period of time. Possible scores range from 1 (no social support) to 25 (most possible social support). Change = (month 9 score - Baseline score)|baseline and month 9|The ESSI was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.||units on a scale||Standard Deviation|Mean
671050|NCT01690117|Secondary|Change From Baseline in Social Support on the ENRICHED-Social-Support-Instrument (ESSI) (5-point Scale) at Month 6|ESSI is a validated, self-reported instrument assessing perceived social support of the caregivers over a undefined period of time. Possible scores range from 1 (no social support) to 25 (most possible social support). Change = (month 6 score - Baseline score)|baseline and month 6|The ESSI was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.||units on a scale||Standard Deviation|Mean
671051|NCT01690117|Secondary|Change From Baseline in Mental Health on the Patient Health Questionnaire - 4 Items (PHQ-4) (4-point Scale) at Month 9|PHQ-4 is a validated, self-reported Instrument assessing mental health over a 2 - week period. Possible scores range from 0 (not mental ill) to 18 (worst possible mental illness). Change = (Month 9 Score - Baseline score)|baseline and month 9|The PHQ-4 was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.||units on a scale||Standard Deviation|Mean
671342|NCT01686451|Other Pre-specified|Comparison of Safety Laboratory Testings (ALT,AST,CPK) Between Simvastatin- and Xuezhikang-groups|Fasting blood samples were collected at weeks 0 (randomization) and 4 (end of study) for clinical chemistry.|Measured at baseline and week 4|||U/L||Standard Deviation|Mean
671052|NCT01690117|Secondary|Change From Baseline in Mental Health on the Patient Health Questionnaire - 4 Items (PHQ-4) (4-point Scale) at Month 6|PHQ-4 is a validated, self-reported Instrument assessing mental health over a 2 - week period. Possible scores range from 0 (not ill) to 18 (worst possible mental illness). Change = (Month 6 Score - Baseline score)|baseline and month 6|The PHQ-4 was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.||units on a scale||Standard Deviation|Mean
671053|NCT01690117|Secondary|Change From Baseline in Somatization on the Patient Health Questionaire - 15 Items (PHQ-15) - Module Somatization at Month 9|PHQ-15 is a validated, self-reported instrument assessing somatization over the last 4-weeks time period. Possible scores range from 0 (no somatization) to 30 (most possible somatization). Change = (Month 9 Score - Baseline score)|baseline and month 9|The PHQ - 15 was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.||units on a scale||Standard Deviation|Mean
671054|NCT01690117|Secondary|Change From Baseline in Somatization on the Patient Health Questionaire - 15 Items (PHQ-15) - Module Somatization at Month 6|PHQ-15 is a validated, self-reported instrument assessing somatization over the last 4-weeks time period. Possible scores range from 0 (no somatization) to 30 (most possible somatization). Change = (Month 6 Score - Baseline score)|baseline and 6 month|The PHQ - 15 was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.||units on a scale||Standard Deviation|Mean
671055|NCT01690117|Primary|Change From Baseline in Burden on the German Version of Zarit Caregiver Burden Interview (ZBI) (5-point Scale) at Month 9|The ZBI is a validated , self-reported instrument assessing burden of caregivers of people with dementia over a undefined period of time. Possible scores range from 0 (no burden) to 88 (highest possible burden). Change = (month 9 - baseline score).|baseline and month 9|The ZBI was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.||units on a scale||Standard Deviation|Mean
671056|NCT01690117|Primary|Change From Baseline in Burden on the German Version of Zarit Caregiver Burden Interview (ZBI) (5-point Scale) at Month 6|The ZBI is a validated , self-reported instrument assessing burden of caregivers of people with dementia over a undefined period of time. Possible scores range from 0 (no burden) to 88 (highest possible burden). Change = (month 6 - baseline score).|baseline and month 6|The ZBI was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS (Statistical Package for the Social Sciences ) - methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.||units on a scale||Standard Deviation|Mean
671057|NCT01690052|Secondary|Number of Participants With Adverse Effects Associated With the Medications|We will record the number and type of side effects associated with each medication.|4 weeks||||||
671058|NCT01690052|Primary|Change From Baseline in Saliva Production in ml.|"The primary outcome measure was the change of stimulated and non-stimulated saliva in ml from the baseline record.
At each appointment (weekly), participants will provide 2 saliva samples to measure their current salivary output. The first measurement will be obtained by having the patient spit as much as he or she could into a cup for five minutes. The amount of saliva in ml will be recorded.
The second measurement will be obtained in a similar manner with the addition of having the patient chew on a block of unflavored wax. Patients will complete weekly questionnaires to help determine which side-effects they experience as they take the medications."|4 weeks|||ml||Standard Deviation|Mean
671059|NCT01690000|Secondary|Changes in Calcium Homeostasis|Calcium homeostasis will be analyzed through blood and urines samples|baseline, after 3, 6, 9 months, and end of study (after 12 months)||||||
671060|NCT01690000|Primary|Changes in Bone Mineral Density (BMD)|Effects of melatonin on BMD will be assessed through DXA-scans|baseline and end of study (after 12 months)|||percentage of change in BMD||Standard Error|Mean
671061|NCT01689857|Secondary|Satisfaction for Serviceability|Satisfaction for serviceability will be performed at the end of the 3 month when the treatment was completed by using Questionaire|the end of the 3 month of the treatment||||||
671062|NCT01689857|Primary|Change From Baseline in Vancouver Scar Scale Score(VSS) at 3 Months|"Scar assessment will be performed at the beginning of the treatment, and at the end of the 3 month when the treatment is completed by using the Vancouver scar scale.VSS assesses 6 variables.
vascularity(range from normal(0 point) to purple(3point)
pigmentation(range from normal(0 point) to hyper-pigmentation(3point)
pliability(range from normal(0 point) to contracture(5point)
height (range from flat(0 point) to above 5mm(3point)
pain(range from none(0 point) to Require medication(2point)
itchiness(range from none(0 point) to Require medication(2point)
We assess total score that are minimum score is 0 and maximum is 18. The lowest score means the best scar condition."|Baseline and 3 months|All participants for whom Vancouver Scar Scale measurements were recorded at Baseline and 3 months.||units on a scale||Standard Deviation|Mean
671063|NCT01689779|Other Pre-specified|Percent (%) Change in Pre-surgical LL-37 2 Weeks After Surgery|The goal is to determine whether pre-operative supplementation with 100,000 IU cholecalciferol (vs. placebo) alters the natural course of changes in vitamin D status within 10-18 days after surgery. To assess vitamin D status, we will measure: 1) 25(OH)D and 2) LL-37.|Patients will be followed between the day of surgery and an average duration of 14 days after surgery|Data are presented as percent change in levels between baseline assessment and 2 weeks after surgery||Percent change in LL-37||Standard Deviation|Mean
671064|NCT01689779|Secondary|Percent (%) Change in Pre-surgical LL-37 Within 24 Hours of Surgery|The goal is to determine whether pre-operative supplementation with 100,000 IU cholecalciferol (vs. placebo) alters the natural course of short-term changes in vitamin D status following surgery. To assess vitamin D status, we will measure: 1) 25(OH)D and 2) LL37.|Patients will be followed between the day of surgery and 1 day after surgery|Data are presented as percent change in levels between baseline assessment and day after surgery||Percent change in LL-37||Standard Deviation|Mean
671065|NCT01689779|Primary|Percent (%) Change in LL-37 5 Days Following Supplementation With 100,000 IU Cholecalciferol|3-7 days before surgery, patients will receive 100,000 IU of cholecalciferol (vs. placebo) during their pre-op assessment. They will also have their baseline vitamin D status measured during this initial visit. The main study outcome is to determine if 100,000 IU cholecalciferol can be given preoperatively to safely boost vitamin D status. To assess vitamin D status, we will measure: 1) 25(OH)D and 2) LL37|Patients will be followed between the initial preoperative evaluation day and an average duration of 5 days|Data are presented as percent change in levels between baseline assessment and day of surgery||percent change in LL-37||Standard Deviation|Mean
671066|NCT01689779|Other Pre-specified|Percent (%) Change in Pre-surgical 25(OH)D 2 Weeks After Surgery|The goal is to determine whether pre-operative supplementation with 100,000 IU cholecalciferol (vs. placebo) alters the natural course of changes in vitamin D status within 10-18 days after surgery. To assess vitamin D status, we will measure: 1) 25(OH)D and 2) LL-37.|Patients will be followed between the day of surgery and an average duration of 14 days after surgery|Data are presented as percent change in levels between baseline assessment and 2 weeks after surgery||Percent change in 25(OH)D||Standard Deviation|Mean
671067|NCT01689779|Secondary|Percent (%) Change in Pre-surgical 25(OH)D Within 24 Hours of Surgery|The goal is to determine whether pre-operative supplementation with 100,000 IU cholecalciferol (vs. placebo) alters the natural course of short-term changes in vitamin D status following surgery. To assess vitamin D status, we will measure: 1) 25(OH)D and 2) LL37.|Patients will be followed between the day of surgery and 1 day after surgery|Data are presented as percent change in levels between baseline assessment and day after surgery||Percent change in 25(OH)D||Standard Deviation|Mean
671068|NCT01689779|Primary|Percent (%) Change in 25(OH)D 5 Days Following Supplementation With 100,000 IU Cholecalciferol|3-7 days before surgery, patients will receive 100,000 IU of cholecalciferol (vs. placebo) during their pre-op assessment. They will also have their baseline vitamin D status measured during this initial visit. The main study outcome is to determine if 100,000 IU cholecalciferol can be given preoperatively to safely boost vitamin D status. To assess vitamin D status, we will measure: 1) 25(OH)D and 2) LL37|Patients will be followed between the initial preoperative evaluation day and an average duration of 5 days|Data are presented as percent change in levels between baseline assessment and day of surgery||percent change in 25(OH)D||Standard Deviation|Mean
671069|NCT01689649|Secondary|Percentage of Participants With Greater Than or Equal to 50%, 75% and 100% Reduction in Seizures With or Without Previous Treatment||Month 4|||percentage of participants|||Number
671070|NCT01689649|Secondary|General Clinical Assessment Before and After Treatment|The general clinical assessment is measured by clinical global impression scale. The scale is used to grade the participants as very good, good, fairly good, medium and Poor before (Visit 1) and after treatment (Visit 6).|Baseline (Day 0) and Month 4|||percentage of participants|||Number
671071|NCT01689649|Secondary|Percentage of Participants With Greater Than or Equal to 50%, 75% and 100% Reduction in Seizures as Per the Seizure Frequency (Less Than 4, 4 to 10 and Greater Than 10) After 16 Weeks||Month 4|||percentage of participants|||Number
671072|NCT01689649|Secondary|Percentage of Participants With Greater Than or Equal to 50%, 75% and 100% Reduction in Seizures as Per the Seizure Types (Partial, Secondarily Generalized and Generalized Tonic and Clonic Siezures) After 16 Weeks||Month 1, Month 3 and Month 4|||percentage of participants|||Number
671073|NCT01689649|Primary|Percentage of Seizure Free Participants During the Last 4 Months of Treatment||Month 1, Month 3 and Month 4|||percentage of participants|||Number
671074|NCT01689649|Primary|Percentage of Participants Wiith Reduction in Number of Seizures Greater Than or Equal to 75%, During the Last 4 Months of Treatment||Month 1, Month 3 and Month 4|||percentage of participants|||Number
671075|NCT01689649|Primary|Percentage of Participants Wiith Reduction in Number of Seizures Greater Than or Equal to 50%, During the Last 4 Months of Treatment||Month 1, Month 3 and Month 4|||percentage of participants|||Number
671076|NCT01689532|Secondary|Change From Baseline in EuroQol 5-Dimensional Questionnaire (EQ-5D) Index Score at Weeks 16, 24 and 52|"Change from Baseline to end point in Euro Quality of life (Qol)-5 Dimension Questionnaire (EQ-5D). A higher score indicates an improvement in health in the Health Status Index. The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating full health and 0 representing dead."|Baseline, Weeks 16, 24 and 52|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.||units on a scale||Standard Deviation|Mean
671077|NCT01689532|Secondary|Change From Baseline in EuroQol 5-Dimensional Questionnaire (EQ-5D) Visual Analog Scale (VAS) Score at Weeks 16, 24 and 52|The EQ-5D VAS records the participant's self-rated health on a vertical, VAS, with 0 representing the worst imaginable health state and 100 representing the best imaginable health state. The EQ VAS is used as a quantitative measure of health outcome as judged by the individual participant.|Baseline, Weeks 16, 24 and 52|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.||units on a scale||Standard Deviation|Mean
671078|NCT01689532|Secondary|Change From Baseline in Physical Component Scores of 36-Item Short Form Health Survey (SF-36) at Weeks 16, 24 and 52|The SF-36 is a survey of participant health. It consists of 8 individual domains, which are weighted sums of the questions in their section. The 8 domains are: vitality (VT), physical functioning (PF), bodily pain (BP), general health (GH), Role-Physical (RP), Role-Emotional (RE), social functioning (SF) and mental health (MH). Each of these 8 scales (domains) is scored from 0 to 100 with higher scores indicating better health. Based on the scale scores, the summary physical component score (PCS) is derived. Scales contributing most to the scoring of the SF-36 PCS include the PF, RP, BP and GH. Other domains not noted contribute to the scoring but to a lesser degree. The scoring is derived based on an algorithm that has been developed in a software provided by the developer. The summary PCS score is also scaled from 0 to 100 with higher scores indicating better health.|Baseline, Weeks 16, 24 and 52|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.||units on a scale||Standard Deviation|Mean
681075|NCT01562314|Secondary|Plasma Endocannabinoid Levels - Anandamide (AEA)|Change from baseline in the endocannabinoid AEA|Baseline to end of treatment (10 weeks treatment period)|ITT analysis set||nmol/L||Standard Deviation|Mean
671079|NCT01689532|Secondary|Change From Baseline in Mental Component Scores of 36-Item Short Form Health Survey (SF-36) at Weeks 16, 24 and 52|The SF-36 is a survey of participant health. It consists of 8 individual domains, which are weighted sums of the questions in their section. The 8 domains are: vitality (VT), physical functioning (PF), bodily pain (BP), general health (GH), Role-Physical (RP), Role-Emotional (RE), social functioning (SF) and mental health (MH). Each of these 8 scales (domains) is scored from 0 to 100 with higher scores indicating better health. Based on the scale scores, the summary mental component score (MCS) is derived. Scales contributing most to the scoring of the SF-36 MCS include the VT, SF, RE and MH. Other domains not noted contribute to the scoring but to a lesser degree. The scoring is derived based on an algorithm that has been developed in a software provided by the developer. The summary MCS score is also scaled from 0 to 100 with higher scores indicating better health.|Baseline, Weeks 16, 24 and 52|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.||units on a scale||Standard Deviation|Mean
671080|NCT01689532|Secondary|Change From Baseline in Duration of Morning Stiffness at Weeks 16 and 24|Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes was recorded). Negative values for this outcome measure represent improvement, i.e. shortening of duration of morning stiffness.|Baseline, Weeks 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.||minute||Standard Deviation|Mean
671081|NCT01689532|Secondary|Area Under Curve (AUC) of Change From Baseline in HAQ-DI Score From Week 0 Through Week 24 and From Week 0 Through Week 52|HAQ-DI consisted of 20-question in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living), each scored from 0 (no difficulty) to 3 (inability to perform a task in that area). Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. AUC of change from baseline in HAQ-DI score is the AUC of change from baseline in HAQ-DI score versus the time. AUC was calculated based on the measurement (i.e., observed HAQ-DI score change from baseline) at scheduled visits using the trapezoidal rule. Functional status was determined as a cumulative measure of HAQ-DI over 1 year by using the AUC of the change from baseline in HAQ-DI score through week 52. Decreases in AUC of change from baseline in HAQ-DI indicate a greater average improvement in physical function over time.|Baseline, Weeks 24 and 52|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.||units on a scale*week||Standard Deviation|Mean
671082|NCT01689532|Secondary|Percentage of Participants Maintaining HAQ-DI Response|The HAQ-DI is a 20-question instrument that assesses the degree of difficulty a participant has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living), each scored from 0 (no difficulty) to 3 (inability to perform a task in that area). HAQ-DI responders who maintain a change from baseline of > -0.22 in HAQ-DI score.|Baseline upto Week 52|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.||percentage of participants|||Number
671083|NCT01689532|Secondary|Percentage of Participants Achieving HAQ-DI Response at Weeks 16 and 24|The HAQ-DI is a 20-question instrument that assesses the degree of difficulty a participant has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living), each scored from 0 (no difficulty) to 3 (inability to perform a task in that area). HAQ-DI response was defined as change of > -0.22 from baseline in HAQ-DI score.|At Weeks 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.||percentage of participants|||Number
671084|NCT01689532|Secondary|Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 16 and 24|The HAQ-DI is a 20-question instrument that assesses the degree of difficulty a participant has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living), each scored from 0 (no difficulty) to 3 (inability to perform a task in that area). Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, at Week 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.||units on a scale||Standard Deviation|Mean
671085|NCT01689532|Secondary|Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Weeks 16 and 24|The SDAI score is a derived score combining tender joints (28 joints), swollen joints (28 joints), patient's global assessment of disease activity, physician's global assessments of disease activity, and CRP. The total score range is 0-86. Score interpretation: Remission SDAI <=3.3; Low Disease Activity SDAI >3.3 and <=11; Moderate Disease Activity SDAI >11 and <=26; High Disease Activity SDAI >26.|Baseline, Weeks 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.||units on a scale||Standard Deviation|Mean
671086|NCT01689532|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Weeks 16 and 24|The CDAI score is a derived score combining tender joints (28 joints), swollen joints (28 joints), patient's global assessment of disease activity, and physician's global assessments of disease activity. The total score range is 0-76. Score interpretation: Remission <=2.8; Low Disease Activity CDAI > 2.8 and <=10; Moderate Disease Activity CDAI >10 and <=22; High Disease Activity CDAI > 22.|Baseline, Weeks 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.||units on a scale||Standard Deviation|Mean
671096|NCT01689532|Secondary|Percent Change From Baseline in Patient's Global Assessment of Disease Activity at Weeks 16 and 24|Participants rated their disease activity using the Visual Analog Scale (VAS) on a scale of 0 (very well) to 10 (very poor).|Baseline, Weeks 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.||percent change||Standard Deviation|Mean
671087|NCT01689532|Secondary|Percentage of Participants With Boolean Based ACR/EULAR Remission at Weeks 16, 24 and 52|The Boolean based ACR/EULAR remission is achieved if all of the following 4 criteria at that visit are met: tender joint count (68 joints) <=1; swollen joint count (66 joints) <=1; CRP <=1 milligram per deciliter (mg/dL); and patient's global assessment of disease activity on visual analog scale (VAS) <=1 on a 0 to 10 scale.|At Weeks 16, 24 and 52|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.||percentage of participants|||Number
671088|NCT01689532|Secondary|Percentage of Participants With Simplified Disease Activity Index (SDAI) Based ACR/European League Against Rheumatism (EULAR) Remission at Weeks 16, 24 and 52|The SDAI score is a derived score combining tender joints (28 joints), swollen joints (28 joints), patient's global assessment of disease activity on VAS, physician’s global assessments of disease activity on VAS, and CRP. SDAI-based ACR/EULAR remission is defined as a SDAI value of <=3.3 at the visit.|At Weeks 16, 24 and 52|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.||percentage of participants|||Number
671089|NCT01689532|Secondary|Change From Baseline in DAS28 (CRP) Score at Weeks 16 and 24|The DAS28 based on C-Reactive Protein (CRP) is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst.|Baseline, Weeks 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.||units on a scale||Standard Deviation|Mean
671090|NCT01689532|Secondary|Percentage of Participants Achieving DAS28 (CRP) Remission at Week 24|The DAS28 based on C-Reactive Protein (CRP) is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. DAS28 (CRP) remission is defined as a DAS28 (CRP) value of less than (<) 2.6 at any study visit.|At Week 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.||percentage of participants|||Number
671091|NCT01689532|Secondary|Percentage of Participants With Disease Activity Index Score 28 (CRP) Response at Weeks 16 and 24|The DAS28 based on C-Reactive Protein (CRP) is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. Good responders: improvement from baseline greater than (>) 1.2 with DAS28 less than or equal to (<=) 3.2; moderate responders: improvement from baseline >1.2 with DAS28 >3.2 to <=5.1 or improvement from baseline >0.6 to <=1.2 with DAS28 <=5.1; non-responders: improvement from baseline <=0.6 or improvement from baseline >0.6 and <=1.2 with DAS28 >5.1.|At Weeks 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.||percentage of participants|||Number
671092|NCT01689532|Secondary|Percentage of Participants Who Achieved Major Clinical Response at Week 52|Major clinical response is achieving ACR 70 for 6 continuous months. The ACR 70 Response is defined as >=70 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=70 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS (0-10 mm, 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS, (The scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI and CRP. Achievement of major clinical response reflects an enhanced level of therapeutic efficacy and sustained reduction of signs and symptoms of rheumatoid arthritis (RA).|Week 52|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.||percentage of participants|||Number
671093|NCT01689532|Secondary|Percent Change From Baseline in C-Reactive Protein (CRP) at Weeks 16 and 24|Serum CRP is a marker of systemic inflammation. A negative percent change from baseline in CRP represents improvement.|Baseline, Weeks 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.||percent change||Standard Deviation|Mean
671094|NCT01689532|Secondary|Percent Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Weeks 16 and 24|The HAQ-DI is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and activities of daily living). Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area). Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. Here, ‘n’ signifies those participants who were evaluable for the specific timepoint.|Baseline, Weeks 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.||percent change||Standard Deviation|Mean
671095|NCT01689532|Secondary|Percent Change From Baseline in Physician's Global Assessment of Disease Activity at Weeks 16 and 24|Physician's Global Assessment of Disease Activity was assessed using the VAS on a scale of 0 (no arthritis activity) to 10 (extremely active arthritis).|Baseline, Weeks 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.||percent change||Standard Deviation|Mean
671367|NCT01685684|Secondary|Weekly Changes in Pain Intensity|Weekly pain intensity scores were calculated based on averaged daily pain intensity scores (PI-NRS). Increases to the weekly change in pain intensity, correspond to increases in the PI-NRS scores (i.e. more pain).|Randomization Baseline and weekly through Week 12|||units on a scale||Standard Deviation|Mean
671097|NCT01689532|Secondary|Percent Change From Baseline in Patient's Assessment of Pain at Weeks 16 and 24|Participants assessed their average pain during the past week on a visual analogue scale (VAS). The scale ranged from 0 (no pain) to 10 (the worst possible pain).|Baseline, Weeks 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.||percent change||Standard Deviation|Mean
671098|NCT01689532|Secondary|Percent Change From Baseline in Number of Tender Joints at Weeks 16 and 24|Sixty eight (68) joints were assessed for tenderness to determine the number of joints that were considered tender. A negative change from baseline in the tender joint count indicates improvement.|Baseline, Weeks 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.||percent change||Standard Deviation|Mean
671099|NCT01689532|Secondary|Percent Change From Baseline in Number of Swollen Joints at Weeks 16 and 24|Sixty six (66) joints were assessed for swelling by investigator to determine the number of joints that were considered swollen. A negative change from baseline in swollen joint count indicates improvement.|Baseline, Weeks 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.||percent change||Standard Deviation|Mean
671100|NCT01689532|Secondary|Percentage of Participants Achieving American College of Rheumatology (ACR) 90 Response|The ACR 90 Response is defined as >=90 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=90 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS (0-10 mm, 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI and CRP.|At Weeks 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.||percentage of participants|||Number
671101|NCT01689532|Secondary|Percentage of Participants Achieving American College of Rheumatology (ACR) 70 Response|The ACR 70 Response is defined as >=70 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=70 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS (0-10 mm, 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI and CRP.|At Weeks 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.||percentage of participants|||Number
671102|NCT01689532|Secondary|Percentage of Participants Achieving American College of Rheumatology (ACR) 50 Response|The ACR 50 Response is defined as >=50 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=50 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS (0-10 mm, 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI and serum CRP.|At Weeks 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.||percentage of participants|||Number
671103|NCT01689532|Secondary|Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response|The ACR 20 Response is defined as greater than or equal to (>=) 20 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=20 percent improvement in 3 of following 5 assessments: patient's assessment of pain using Visual Analog Scale (VAS; 0-10 millimeter [mm], 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and serum C-Reactive Protein (CRP).|At Weeks 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.||percentage of participants|||Number
671104|NCT01689532|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAE)|A TEAE was defined as an event that occurred in the treatment period during which it emerged (that is [i.e.] started or worsened in severity, relation, or other attribute), and even if the event continued to be present.|Baseline upto Week 68|Safety analyses set included all participants who received at least 1 (partial or complete) dose of the study drug.||participants|||Number
671105|NCT01689519|Secondary|Overall Survival (Final Analysis)|Overall survival was defined as the time from randomization until the date of death from any cause.|Baseline to the 28 August 2015 Overall Survival data cut-off (up to 2 years, 8 months)|Intent-to-treat population: All randomized participants, regardless of whether or not study treatment was received.||Months||95% Confidence Interval|Median
671106|NCT01689519|Secondary|Duration of Response|Duration of response was defined as the time from first occurrence of a documented confirmed objective response until the time of disease progression, as determined by investigator review of tumor assessments using Response Evaluation Criteria in Solid Tumors v1.1 or death from any cause during the study. Disease progression was defined as: (1) at least a 20% increase in the sum (the increase in the sum must be at least 5 mm) of diameters of target lesions, taking as reference the smallest sum during the study; (2) unequivocal progression of existing non-target lesions; or (3) the appearance of 1 or more new lesions.|Baseline to the 09 May 2014 data cut-off (up to 1 year, 4 months)|Intent-to-treat population: All randomized participants, regardless of whether or not study treatment was received. Only participants with an objective response were included in the analysis.||Months||95% Confidence Interval|Median
671144|NCT01689324|Other Pre-specified|Geometric Mean Concentrations With Respect to Diphtheria and Tetanus Antibodies Pre- and Post-vaccination With ADACEL®||Day 0 (pre-vaccination) and Day 28 post-vaccination|Pre and post vaccination geometric mean concentrations to Diphtheria and Tetanus antigens were determined in the Immunology Analysis Set||Titers||95% Confidence Interval|Geometric Mean
671107|NCT01689519|Secondary|Percentage of Participants With an Objective Response|An objective response was defined as a complete response or a partial response determined on two consecutive occasions ≥ 4 weeks apart. Responses were determined by Response Evaluation Criteria in Solid Tumors v1.1. A complete response was defined as the disappearance of all target lesions or the disappearance of all non-target lesions and normalization of tumor marker level. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameter of target lesions.|Baseline to the 09 May 2014 data cut-off (up to 1 year, 4 months)|Intent-to-treat population: All randomized participants, regardless of whether or not study treatment was received.||Percentage of participants||95% Confidence Interval|Number
671108|NCT01689519|Secondary|Overall Survival|Overall survival was defined as the time from randomization until the date of death from any cause.|Baseline to the 09 May 2014 data cut-off (up to 1 year, 4 months)|Intent-to-treat population: All randomized participants, regardless of whether or not study treatment was received.||Months||95% Confidence Interval|Median
671109|NCT01689519|Primary|Progression-free Survival|Progression-free survival was defined as the time from randomization to the first occurrence of disease progression, as determined by the investigator using Response Evaluation Criteria in Solid Tumors v1.1, or death from any cause, whichever came first. Disease progression was defined as: (1) at least a 20% increase in the sum (the increase in the sum must be at least 5 mm) of diameters of target lesions, taking as reference the smallest sum during the study; (2) unequivocal progression of existing non-target lesions; or (3) the appearance of 1 or more new lesions.|Baseline to the 09 May 2014 data cut-off (up to 1 year, 4 months)|Intent-to-treat population: All randomized participants, regardless of whether or not study treatment was received.||Months||95% Confidence Interval|Median
671110|NCT01689441|Secondary|Urinary Neutrophil Gelatinase-associated Lipocalin (NGAL) / Creatinine Ratio at 48 Hours|NGAL is a urinary marker of renal tubular injury. NGAL levels were normalized to the urinary creatinine concentration to account for the influence of dilution on biomarker concentrations.|48 hours|"The discrepancy in number of participants analyzed for this outcome vs. other outcomes is due to urine samples not being available in all participants"||mg/mg||Inter-Quartile Range|Median
671111|NCT01689441|Secondary|Plasma Interleukin-6 (IL-6) Levels at 48 Hours||48 hours|||pg/ml||Inter-Quartile Range|Median
671112|NCT01689441|Primary|Plasma Cathelicidin (hCAP18) Protein Levels at 48 Hours||48 hours|||ng/ml||Inter-Quartile Range|Median
671113|NCT01689363|Secondary|Allergic Wheal Size in the Intent-to-Treat Population (ITT)|Subjects received intradermal injections at 4 injection sites following a randomized configuration of study medications. Injection sites were monitored for any characteristic immediate reactions after the study drug injections. The allergic wheal size is the greatest wheal diameter with accompanying erythema and localized itching measured at the injection site(s) for a specific study drug injection.|Up to 30 minutes after the final study drug injection|Subjects who have been randomized||mm||Standard Deviation|Mean
671114|NCT01689363|Secondary|Erythema Responder Rate in the Intent-to-Treat Population (ITT)|Subjects received intradermal injections at 4 injection sites following a randomized configuration of study medications. Injection sites were monitored for any characteristic immediate reactions after the study drug injections. The erythema responder rate is the percentage of subjects that showed an erythema reaction at the injection site(s) for a specific study drug injection.|Up to 30 minutes after the final study drug injection|Subjects who have been randomized||percentage of participants|||Number
671115|NCT01689363|Secondary|Local Itchiness Rate in the Intent-to-Treat Population (ITT)|Subjects received intradermal injections at 4 injection sites following a randomized configuration of study medications. Injection sites were monitored for any characteristic immediate reactions after the study drug injections. The local itchiness rate is the percentage of subjects that reported localized itching at the injection site(s) for a specific study drug injection.|Up to 30 minutes after the final study drug injection|Subjects who have been randomized||percentage of participants|||Number
671116|NCT01689363|Secondary|Allergic Erythema Size in the Intent-to-Treat Population (ITT)|Subjects received intradermal injections at 4 injection sites following a randomized configuration of study medications. Injection sites were monitored for any characteristic immediate reactions after the study drug injections. The allergic erythema size is the greatest erythema diameter with accompanying localized itching measured at the injection site(s) for a specific study drug injection.|Up to 30 minutes after the final study drug injection|Subjects who have been randomized||mm||Standard Deviation|Mean
671117|NCT01689363|Secondary|Observed Erythema Size in the Intent-to-Treat Population (ITT)|Subjects received intradermal injections at 4 injection sites following a randomized configuration of study medications. Injection sites were monitored for any characteristic immediate reactions after the study drug injections. The observed erythema size is the greatest erythema diameter measured at the injection site(s) for a specific study drug injection.|Up to 30 minutes after the final study drug injection|Subjects who have been randomized||mm||Standard Deviation|Mean
671118|NCT01689363|Secondary|Observed Wheal Size in the Intent-to-Treat Population (ITT)|Subjects received intradermal injections at 4 injection sites following a randomized configuration of study medications. Injection sites were monitored for any characteristic immediate reactions after the study drug injections. The observed wheal size is the greatest wheal diameter measured at the injection site(s) for a specific study drug injection.|Up to 30 minutes after the final study drug injection|Subjects who have been randomized||mm||Standard Deviation|Mean
671119|NCT01689363|Secondary|Erythema Responder Rate in the Per-Protocol Population (PPP)|Subjects received intradermal injections at 4 injection sites following a randomized configuration of study medications. Injection sites were monitored for any characteristic immediate reactions after the study drug injections. The erythema responder rate is the percentage of subjects that showed an erythema reaction at the injection site(s) for a specific study drug injection.|Up to 30 minutes after the final study drug injection|Subjects who: a) have received the right treatment; b) have a negative reaction for the negative control; c) have a positive reaction for the positive control; and d) have the same reaction for both Amphadase® treatments||percentage of participants|||Number
671133|NCT01689337|Secondary|Composition of the Refilled Cartilage Using T2 Mapping|The transverse relaxation time T2 mapping is an MRI technique that is able to evaluate collagen organization and orientation within cartilage. Composition of the refilled cartilage was to be reported.|Every 6 months up to 5 years|Efficacy analysis was not performed as only one participant was enrolled in the study. The study was terminated due to low recruitment.|||||
671120|NCT01689363|Secondary|Local Itchiness Rate in the Per-Protocol Population (PPP)|Subjects received intradermal injections at 4 injection sites following a randomized configuration of study medications. Injection sites were monitored for any characteristic immediate reactions after the study drug injections. The local itchiness rate is the percentage of subjects that reported localized itching at the injection site(s) for a specific study drug injection.|Up to 30 minutes after the final study drug injection|Subjects who: a) have received the right treatment; b) have a negative reaction for the negative control; c) have a positive reaction for the positive control; and d) have the same reaction for both Amphadase® treatments||percentage of participants|||Number
671121|NCT01689363|Secondary|Allergic Erythema Size in the Per-Protocol Population (PPP)|Subjects received intradermal injections at 4 injection sites following a randomized configuration of study medications. Injection sites were monitored for any characteristic immediate reactions after the study drug injections. The allergic erythema size is the greatest erythema diameter with accompanying localized itching measured at the injection site(s) for a specific study drug injection.|Up to 30 minutes after the final study drug injection|Subjects who: a) have received the right treatment; b) have a negative reaction for the negative control; c) have a positive reaction for the positive control; and d) have the same reaction for both Amphadase® treatments||mm||Standard Deviation|Mean
671122|NCT01689363|Secondary|Allergic Wheal Size in the Per-Protocol Population (PPP)|Subjects received intradermal injections at 4 injection sites following a randomized configuration of study medications. Injection sites were monitored for any characteristic immediate reactions after the study drug injections. The allergic wheal size is the greatest wheal diameter with accompanying erythema and localized itching measured at the injection site(s) for a specific study drug injection.|Up to 30 minutes after the final study drug injection|Subjects who: a) have received the right treatment; b) have a negative reaction for the negative control; c) have a positive reaction for the positive control; and d) have the same reaction for both Amphadase® treatments||mm||Standard Deviation|Mean
671123|NCT01689363|Secondary|Observed Erythema Size in the Per-Protocol Population (PPP)|Subjects received intradermal injections at 4 injection sites following a randomized configuration of study medications. Injection sites were monitored for any characteristic immediate reactions after the study drug injections. The observed erythema size is the greatest erythema diameter measured at the injection site(s) for a specific study drug injection.|Up to 30 minutes after the final study drug injection|Subjects who: a) have received the right treatment; b) have a negative reaction for the negative control; c) have a positive reaction for the positive control; and d) have the same reaction for both Amphadase® treatments||mm||Standard Deviation|Mean
671124|NCT01689363|Secondary|Observed Wheal Size in the Per-Protocol Population (PPP)|Subjects received intradermal injections at 4 injection sites following a randomized configuration of study medications. Injection sites were monitored for any characteristic immediate reactions after the study drug injections. The observed wheal size is the greatest wheal diameter measured at the injection site(s) for a specific study drug injection.|Up to 30 minutes after the final study drug injection|Subjects who: a) have received the right treatment; b) have a negative reaction for the negative control; c) have a positive reaction for the positive control; and d) have the same reaction for both Amphadase® treatments||mm||Standard Deviation|Mean
671125|NCT01689363|Primary|Positive Allergic Reaction to Amphadase® in the Intent-to-Treat Population (ITT)|Subjects received intradermal injections at 4 injection sites following a randomized configuration of study medications. Injection sites were monitored for any characteristic immediate reactions after the study drug injections. A positive reaction consisted of: a) reaction appearing within 30 minutes of drug placement; b) wheal (>8 mm) with or without pseudopods; c) reaction accompanying erythema; and d) reaction accompanying localized itching.|Up to 30 minutes after the final study drug injection|Subjects who have been randomized||participants|||Number
671126|NCT01689363|Primary|Positive Allergic Reaction to Amphadase® in the Per-Protocol Population (PPP)|Subjects received intradermal injections at 4 injection sites following a randomized configuration of study medications. Injection sites were monitored for any characteristic immediate reactions after the study drug injections. A positive reaction consisted of: a) reaction appearing within 30 minutes of drug placement; b) wheal (>8 mm) with or without pseudopods; c) reaction accompanying erythema; and d) reaction accompanying localized itching.|Up to 30 minutes after the final study drug injection|Subjects who: a) have received the right treatment; b) have a negative reaction for the negative control; c) have a positive reaction for the positive control; and d) have the same reaction for both Amphadase® treatments||participants|||Number
671127|NCT01689350|Secondary|Adverse Reaction ( Infection )|Flu-like symptoms, Upper respiratory tract infection，and the etc.|one month|||participants|||Number
671128|NCT01689350|Primary|Adverse Reaction (Leucopenia)|The count of white cells < 4.0 × 10ˆ9/L in SLE patient who received CPA medication was considered as CPA-induced leucopenia.|one month|||participants|||Number
671129|NCT01689337|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. An SAE is an AE that results in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.|Baseline up to Month 60|The safety analysis set included all participants who received at least 1 dose of trial drug.||participants|||Number
671130|NCT01689337|Secondary|Six-minute Walk Test|Six (6)-minute walk test is used to measure gait function and for pre- and post-operative evaluation in cartilage injury repair. Maximum comfortable distance (in meters) that a participant can walk in 6 minutes was to be reported.|Every 3 months up to 5 years beyond Month 6 post-MFx surgery|Efficacy analysis was not performed as only one participant was enrolled in the study. The study was terminated due to low recruitment.|||||
671131|NCT01689337|Secondary|Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Score|The MOCART score is used to describe the constitution of the cartilage repair tissue and the surrounding structures.|Every 6 months up to 5 years|Efficacy analysis was not performed as only one participant was enrolled in the study. The study was terminated due to low recruitment.|||||
671132|NCT01689337|Secondary|Volume of the Refilled Cartilage|Volume of the refilled cartilage was to be measured by MRI.|Every 6 months up to 5 years|Efficacy analysis was not performed as only one participant was enrolled in the study. The study was terminated due to low recruitment.|||||
671562|NCT01683604|Secondary|Duration of Tocilizumab Treatment||Baseline up to Month 6|FAS population.||days||Standard Deviation|Mean
671134|NCT01689337|Secondary|Change From Baseline in the Physician-reported Outcome Measure: Lysholm Knee Scale Score|The Lysholm knee scale is a physician-reported outcome measure to assess knee function after ligament injury. It is scaled from 0 to 100 with higher scores representing better function. Change from baseline in Lysholm knee scale score was to be calculated by the score at the specific time point minus the score at baseline.|Every 6 months up to 5 years|Efficacy analysis was not performed as only one participant was enrolled in the study. The study was terminated due to low recruitment.|||||
671135|NCT01689337|Secondary|Change From Baseline in Participant-reported Outcome Measure: Lower Extremity Activity Scale (LEAS) Score|The LEAS is an 18-level single-question self-administered scale that has been validated as a clinical outcome measure for the assessment of participants’ actual activity levels. The LEAS is scaled from 1 to 18, with 18 indicating levels of highest activity. Change from baseline in LEAS score was to be calculated by the score at the specific time point minus the score at baseline.|Every 6 months up to 5 years|Efficacy analysis was not performed as only one participant was enrolled in the study. The study was terminated due to low recruitment.|||||
671136|NCT01689337|Secondary|Change From Baseline in Participant-reported Outcome Measure: Numeric Rating Scale (NRS) Score|Knee pain was to be rated by the participant using an 11-point NRS of pain intensity. The NRS is scaled from 0 (no pain) to 10 (worst possible pain). Change from baseline in NRS score was to be calculated by the score at the specific time point minus the score at baseline.|Every 6 months up to 5 years|Efficacy analysis was not performed as only one participant was enrolled in the study. The study was terminated due to low recruitment.|||||
671137|NCT01689337|Secondary|Change From Baseline in Participant-reported Outcome Measure: Total KOOS Score, Three KOOS Sub-scores and Total KOOS Minus FSR Sub-score|The KOOS Version LK1.0 is a knee-specific self-administered questionnaire used to assess pain, function, quality of life, and ADL. It consists of 42 items grouped into 5 subscales: pain, other symptoms (including swelling, restricted range of motion, and mechanical symptoms), function in ADL, FSR, and impact on QOL (knee-related QOL, including awareness of the knee condition and changes in lifestyle). The subscales are scored separately; each yields a score between 0 and 100, with 0 representing extreme knee problems and 100 representing absence of problems. Total KOOS score is the average of all 5 subscale scores; ranging from 0 to 100; where 0 represents extreme knee problems and 100 represents absence of knee problems. Change from baseline in total KOOS score; other symptoms, knee-related QOL, and FSR sub-scores; and total KOOS minus FSR sub-score was to be calculated by the respective scores at the specific time point minus the scores at baseline.|Every 6 months up to 5 years|Efficacy analysis was not performed as only one participant was enrolled in the study. The study was terminated due to low recruitment.|||||
671138|NCT01689337|Secondary|Change From Baseline in Participant-reported Outcome Measure: Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scores for Pain and Activities of Daily Living (ADL)|The KOOS Version LK1.0 is a knee-specific self-administered questionnaire used to assess pain, function, quality of life, and ADL. It consists of 42 items grouped into 5 subscales: pain, other symptoms (including swelling, restricted range of motion, and mechanical symptoms), function in ADL, function in sport and recreation (FSR), and impact on quality of life (QOL) (knee-related QOL, including awareness of the knee condition and changes in lifestyle). The subscales are scored separately; each yields a score between 0 and 100, with 0 representing extreme knee problems and 100 representing absence of problems. Total KOOS score is the average of all 5 subscale scores; ranging from 0 to 100; where 0 represents extreme knee problems and 100 represents absence of knee problems. Change from baseline in pain and ADL sub-scores was to be calculated by the respective scores at the specific time point minus the scores at baseline.|Every 6 months up to 5 years|Efficacy analysis was not performed as only one participant was enrolled in the study. The study was terminated due to low recruitment.|||||
671139|NCT01689337|Secondary|Composition of the Refilled Cartilage Measured by dGEMRIC Using T1 Relaxation Time Beyond Month 6 Post-MFx Surgery|The dGEMRIC is an imaging technique that estimates the proteoglycan (and glycosaminoglycan) content of joint cartilage using spin-lattice relaxation time T1 after penetration of gadolinium contrast agent. Composition of the refilled cartilage was to be reported.|Every 6 months up to 5 years beyond 6 months post-MFx surgery|Efficacy analysis was not performed as only one participant was enrolled in the study. The study was terminated due to low recruitment.|||||
671140|NCT01689337|Primary|Composition of the Refilled Cartilage Measured by Delayed Gadolinium-Enhanced Magnetic Resonance Imaging of Cartilage (dGEMRIC) Using T1 Relaxation Time at Month 6 Post-MFx Surgery|The dGEMRIC is an imaging technique that estimates the proteoglycan (and glycosaminoglycan) content of joint cartilage using spin-lattice relaxation time T1 after penetration of gadolinium contrast agent. Composition of the refilled cartilage was to be reported.|6 months post-MFx surgery|Efficacy analysis was not performed as only one participant was enrolled in the study. The study was terminated due to low recruitment.|||||
671141|NCT01689324|Other Pre-specified|Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With ADACEL®|"Solicited injection-site reactions: Pain, Redness, and Swelling. Grade 3: Pain, Significant, prevents daily activity; Redness and Swelling, >100 mm.
Solicited systemic reactions: Fever (Temperature); Headache, Malaise, and Myalgia. Grade 3: Fever, ≥ 39°C; Headache, Malaise and Myalgia, Significant, prevents daily activity."|Day 0 up to Day 7 post-vaccination|Solicited injection site and systemic reactions were assessed in the Safety Analysis Set||Participants|||Number
671142|NCT01689324|Other Pre-specified|Percentage of Participants With Booster Response to Pertussis Antigens, Pertactin and Fimbriae Following Vaccination With ADACEL®|Booster responses were defined as: Pre-vaccination antibody concentrations less than the lower limit of quantitation (LLOQ) and a post-vaccination levels ≥ 4x LLOQ; or Pre-vaccination antibody concentrations ≥ LLOQ but < 4x LLOQ, and a 4-fold rise (i.e., post-/pre-vaccination ≥ 4), or Pre-vaccination antibody concentrations ≥ 4x LLOQ and a 2-fold rise (i.e., post-/pre-vaccination ≥ 2)|Day 28 post-vaccination|Booster response to pertussis antigens were determined in the Immunology Analysis Set||Percentage of Participants|||Number
671143|NCT01689324|Other Pre-specified|Geometric Mean Concentrations With Respect to Pertussis Antibodies Pre- and Post-vaccination With ADACEL®||Day 0 (pre-vaccination) and Day 28 post-vaccination|Pre and post vaccination geometric mean concentrations to pertussis antibodies were determined in the Immunology Analysis Set||Titers||95% Confidence Interval|Geometric Mean
671145|NCT01689324|Other Pre-specified|Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens Pre-vaccination and Post-vaccination With ADACEL®|Seroprotection was defined as the percentage of participants with antibody concentration of ≥1.0 IU/mL.|Day 0 (pre-vaccination) and day 28 post-vaccination|Pre- and post-vaccination seroprotection to diphtheria and tetanus antigens were determined in the Immunology Analysis Set||Percentage of Participants|||Number
671146|NCT01689324|Other Pre-specified|Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Pre-vaccination and Post-vaccination With ADACEL®|Seroprotection was defined as the percentage of participants with antibody concentration of ≥0.01 IU/mL.|Day 0 (pre-vaccination) and day 28 post-vaccination|Pre- and post-vaccination seroprotection to diphtheria and tetanus antigens were determined in the Immunology Analysis Set.||Percentage of Participants|||Number
671147|NCT01689324|Other Pre-specified|Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens Pre-vaccination With ADACEL®|Seroprotection was defined as the percentage of participants with antibody concentration of ≥0.1 IU/mL.|Day 0 pre-vaccination|Pre-vaccination seroprotection to diphtheria and tetanus antigens were determined in the Immunology Analysis Set||Percentage of Participants|||Number
671148|NCT01689324|Primary|Percentage of Participants With Booster Response to Pertussis Antigens, Pertussis Toxoid and Filamentous Hemagglutinin Following Vaccination With ADACEL®|Booster responses were defined as: Pre-vaccination antibody concentrations less than the lower limit of quantitation (LLOQ) and a post-vaccination levels ≥ 4x LLOQ; or Pre-vaccination antibody concentrations ≥ LLOQ but < 4x LLOQ, and a 4-fold rise (i.e., post-/pre-vaccination ≥ 4), or Pre-vaccination antibody concentrations ≥ 4x LLOQ and a 2-fold rise (i.e., post-/pre-vaccination ≥ 2)|Day 28 post-vaccination|Booster response to pertussis antigens were determined in the Immunology Analysis Set||Percentage of Participants|||Number
671149|NCT01689324|Primary|Percentage of Participants With Booster Response to Diphtheria and Tetanus Antigens Following Vaccination With ADACEL®|"Diphtheria booster response was defined as a ≥ 4-fold rise in pre- to post-vaccination antitoxin concentration in a subject with a pre-vaccination antitoxin concentration ≤ 2.56 IU/mL; or a ≥ 2-fold rise in a subject with a pre-vaccination antitoxin concentration > 2.56 IU/mL.
Tetanus booster response was defined as a ≥ 4-fold rise in pre- to post- vaccination antitoxin concentration in a subject with a pre-vaccination antitoxin concentration ≤ 2.7 IU/mL; or a ≥ 2-fold rise in a subject with a pre-vaccination antitoxin concentration > 2.7 IU/mL."|Day 28 post-vaccination|Booster response to diphtheria and tetanus antigens were determined in the Immunology Analysis Set||Percentage of Participants|||Number
671150|NCT01689324|Primary|Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens Following Vaccination With ADACEL®|Seroprotection was defined as the percentage of participants with antibody concentration of ≥0.1 IU/mL, post-vaccination.|Day 28 post-vaccination|Seroprotection to diphtheria and tetanus antigens were determined in the Immunology Analysis Set||Percentage of Participants|||Number
671151|NCT01689207|Secondary|PK- Plasma Pharmacokinetic Parameter Vss for Aztreonam (ATM) and Avibactam (AVI) Alone and in Combination (ATM-AVI) in Parts A, B and C|Volume of distribution at steady state (Vss).|0 to 24 hours post-dose on Day 1 in Part A. 0 to 24 hours post-dose on Days 1, 2, 4 and 11 in Part B (varied intervals per cohort). 0 to 6 hours post-dose on Days 1, 4, 7 and 10 in Part C. Steady state measure on Day 11 in Part B or Day 10 in Part C|Pharmacokinetic analysis set. Please note, PK parameters have not been calculated where data is available in <3 subjects as this is considered to lack robustness. Placebo arms are not evaluated. Values shown where analysed (eg. not applicable for ATM alone in combination cohorts)||L||Geometric Coefficient of Variation|Geometric Mean
671152|NCT01689207|Secondary|PK- Plasma Pharmacokinetic Parameters CL and CLr for Aztreonam (ATM) and Avibactam (AVI) Alone and in Combination (ATM-AVI) in Parts A, B and C|Systemic clearence (CL) and renal clearance (CLr) on Day 1 after single infusion and at steady state after multiple infusion.|0 to 24 hours post-dose on Day 1 in Part A. 0 to 24 hours post-dose on Days 1, 2, 4 and 11 in Part B (varied intervals per cohort). 0 to 6 hours post-dose on Days 1, 4, 7 and 10 in Part C. Steady state measure on Day 11 in Part B or Day 10 in Part C|Pharmacokinetic analysis set. Please note, PK parameters have not been calculated where data is available in <3 subjects as this is considered to lack robustness. Placebo arms are not evaluated. Values shown where analysed (eg. not applicable for ATM alone in combination cohorts)||L/h||Geometric Coefficient of Variation|Geometric Mean
671153|NCT01689207|Secondary|PK- Plasma Pharmacokinetic Parameter Cmax for Aztreonam (ATM) and Avibactam (AVI) Alone and in Combination (ATM-AVI) in Parts A, B and C|Maximum plasma concentration (Cmax µg/mL) on Day 1 after single infusion , maximum plasma concentration at steady state (Css,max µg/mL) after multiple infusion.|0 to 24 hours post-dose on Day 1 in Part A. 0 to 24 hours post-dose on Days 1, 2, 4 and 11 in Part B (varied intervals per cohort). 0 to 6 hours post-dose on Days 1, 4, 7 and 10 in Part C. Steady state measure on Day 11 in Part B or Day 10 in Part C|Pharmacokinetic analysis set. Please note, PK parameters have not been calculated where data is available in <3 subjects as this is considered to lack robustness. Placebo arms are not evaluated. Values shown where analysed (eg. not applicable for ATM alone in combination cohorts)||ug/mL||Geometric Coefficient of Variation|Geometric Mean
671154|NCT01689207|Secondary|PK- Plasma Pharmacokinetic Parameter Tmax for Aztreonam (ATM) and Avibactam (AVI) Alone and in Combination (ATM-AVI) on Day 1 in Parts A, B and C|Time to Cmax (tmax)|Day 1|Pharmacokinetic analysis set. Please note, PK parameters have not been calculated where data is available in <3 subjects as this is considered to lack robustness. Placebo arms are not evaluated. Values shown where analysed (eg. not applicable for ATM alone in combination cohorts)||(h)||Full Range|Median
671155|NCT01689207|Secondary|PK- Plasma Pharmacokinetic Parameter t1/2(h) for Aztreonam (ATM) and Avibactam (AVI) Alone and in Combination (ATM-AVI) in Parts A, B and C|Terminal half-life (t1/2), on Day 1 after single infusion and at steady state after multiple infusion.|0 to 24 hours post-dose on Day 1 in Part A. 0 to 24 hours post-dose on Days 1, 2, 4 and 11 in Part B (varied intervals per cohort). 0 to 6 hours post-dose on Days 1, 4, 7 and 10 in Part C. Steady state measure on Day 11 in Part B or Day 10 in Part C|Pharmacokinetic analysis set. Please note, PK parameters have not been calculated where data is available in <3 subjects as this is considered to lack robustness. Placebo arms are not evaluated. Values shown where analysed (eg. not applicable for ATM alone in combination cohorts)||h||Geometric Coefficient of Variation|Geometric Mean
671156|NCT01689207|Secondary|PK- Plasma Pharmacokinetic Parameter AUC (ug*h/mL) for Aztreonam (ATM) and Avibactam (AVI) Alone and in Combination (ATM-AVI) in Parts A, B and C|Area under the plasma concentration-time curve from zero extrapolated to infinity (AUC µg*h/mL) or AUC(0-last) in Part A on Day 1 after single infusion, area under the plasma concentration-time curve at steady state after multiple infusion (AUCss µg*h/mL).|0 to 24 hours post-dose on Day 1 in Part A. 0 to 24 hours post-dose on Days 1, 2, 4 and 11 in Part B (varied intervals per cohort). 0 to 6 hours post-dose on Days 1, 4, 7 and 10 in Part C. Steady state measure on Day 11 in Part B or Day 10 in Part C|Pharmacokinetic analysis set. Please note, PK parameters have not been calculated where data is available in <3 subjects as this is considered to lack robustness.||ug*h/mL||Geometric Coefficient of Variation|Geometric Mean
671157|NCT01689207|Primary|Safety Profile - Number of Subjects With at Least 1 AE|from screening visit (Day -28) to 3 to 7 days post treatment period 3 (up to Day 22) in Part A, 3 to 7 days after receiving the final dose on Day 11 (days 14 to 18) in Part B, and 3 to 7 days after receiving the final dose on Day 10 (days 13 to 17) in Part C.|Informed consent (up to 28 days before first dose) to follow up period (max of 22 days after first dose for Part A, a max of 28 days after first dose in Part B, max 17 days in Part C)|Safety population||Participants|||Number
671158|NCT01689155|Other Pre-specified|Rates of Safety Outcomes at Days 0–30 vs Days 31-75 After Menactra Vaccine - Clinic Database.|Incidence rates for pre-specified events were to be calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each comparison widow. The risk window was Days 0-30 following vaccination; the control window was Days 31-75 post-vaccination. Pre-specified neurological conditions, hypersensitivity reactions, and new-onset autoimmune disease were selected for monitoring in the clinical database. Note: None of these events were identified in the clinic database.|Day 0 up to Day 75 post-vaccination|All participants who received Menactra vaccine during the study period and captured in the KPNC databases were included in the analysis.||Events per 1,000 person-months|||Number
671159|NCT01689155|Other Pre-specified|Rates of Safety Outcomes at Days 0–30 vs Days 31-75 After Menactra Vaccine - Hospital Database.|Incidence rates for identified events were to be calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each comparison widow. The risk window was Days 0-30 following vaccination; the control window was Days 31-75 post-vaccination. Note: No events were identified in the hospital database.|Day 0 up to Day 75 post-vaccination|All participants who received Menactra vaccine during the study period and captured in the KPNC databases were included in the analysis.||Events per 1,000 person-months|||Number
671160|NCT01689155|Primary|Rates of Safety Outcomes at Days 0–30 vs Days 31-75 After Menactra Vaccine - Emergency Room Database.|Incidence rates for each event were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each comparison widow. The risk window was Days 0-30 following vaccination; the control window was Days 31-75 post-vaccination.|Day 0 up to Day 75 post-vaccination|Eligible participants who received Menactra vaccine during the study period and captured in the KPNC databases were included in the analysis.||Events per 1,000 person-months|||Number
671171|NCT01688882|Secondary|Number of Patients Investigator Global Assessment Score Over 12 Weeks|Investigator’s Global Assessment (IGA) - (scale of 0 to 4, where 0=clear, 1=almost clear, 2=mild, 3=moderate and 4=severe)|Baseline (week 0), week 6 and week 12|Pharmacodynamics (PD) analysis set included all randomized patients.||Number of participants|||Number
671172|NCT01688882|Secondary|Response Based on Clinical Global Assessment of Change CGA-C Score at 6 Weeks|"Clinical Global Assessment of Change (CGA-C) responder rate was the responder rate at 6 weeks based on the CGA-C score in bullous pemphigoid (BP).
A patient with a CGA-C score of 3 or 4 indicating marked improvement from baseline at 6 weeks was considered a responder. The CGA-C is an investigator assessment of change from baseline and is scored as follows: -4 = Very marked worsening (100% worsening); -3 = Marked worsening (67-99% worsening); -2 = Moderate worsening (34-66% worsening); -1 = Slight worsening (1-33% worsening); 1= Slight improvement (1-33% improvement); 2 = Moderate improvement (34-66% improvement); 3 = Marked improvement (67-99% improvement); 4 = Complete clearance (100% improvement)"|6 weeks|Pharmacodynamics (PD) analysis set included all randomized patients.||number of participants|||Number
671173|NCT01688882|Primary|Number of Patients That Had a Clinical Global Assessment of Change (CGA-C) Responder Rate by Week 12|"Clinical Global Assessment of Change (CGA-C) responder rate was the responder rate at 12 weeks based on the CGA-C in bullous pemphigoid (BP).
A patient with a CGA-C score of 3 or 4 indicating ‘at least marked improvement from baseline’ at 12 weeks was considered a responder. The CGA-C is an investigator assessment of change from baseline and is scored as follows: -4 = Very marked worsening (100% worsening); -3 = Marked worsening (67-99% worsening); -2 = Moderate worsening (34-66% worsening); -1 = Slight worsening (1-33% worsening); 1= Slight improvement (1-33% improvement); 2 = Moderate improvement (34-66% improvement); 3 = Marked improvement (67-99% improvement); 4 = Complete clearance (100% improvement)"|12 weeks|Pharmacodynamics (PD) analysis set included all randomized patients.||number of participants|||Number
671174|NCT01688830|Secondary|AUECt1-t2 (Area Under the Effect Curve From Time Point t1 to Time Point t2) on Day 3 and Day 4 (Determined Under Consideration of the Baseline Value) for Part 3 of the Study|"AUECt1-t2 (area under the effect curve from time point t1=2 hours to time point t2=12 hours) on Day 3 and Day 4 (determined under consideration of the baseline value).
Ratio of above baseline AUEC(2−12) on Day 4 to above baseline AUEC(2−12) on Day 3 is presented.
This endpoint was determined for Activated Partial Thromboplastin time (aPTT) and Dithiothreitol (dTT)"|2hours-12 hours|"Pharmacodynamic set (PDS) : The PDS was used for all PD analyses and comprised all subjects in the TS who provided at least 1 evaluable predose and
1 on-treatment observation for calculating ratio (PD endpoint) and who had no important protocol violations relevant to the evaluation of PD."||ratio||Standard Deviation|Mean
671175|NCT01688830|Secondary|AUECt1-t2 (Area Under the Effect Curve From Time Point t1 to Time Point t2) on Day 3 and Day 4 (Determined Under Consideration of the Baseline Value) for Part 2 of the Study|"AUECt1-t2 (area under the effect curve from time point t1=2 hours to time point t2=12 hours) on Day 3 and Day 4 (determined under consideration of the baseline value).
Ratio of above baseline AUEC(2−12) on Day 4 to above baseline AUEC(2−12) on Day 3 is presented.
This endpoint was determined for Activated Partial Thromboplastin time (aPTT), Dithiothreitol (dTT), Thrombin time (TT) and Ecarin clotting time (ECT)"|2hours-12 hours|"Pharmacodynamic set (PDS) : The PDS was used for all PD analyses and comprised all subjects in the TS who provided at least 1 evaluable predose and
1 on-treatment observation for calculating ratio (PD endpoint) and who had no important protocol violations relevant to the evaluation of PD."||ratio||Standard Deviation|Mean
671176|NCT01688830|Secondary|AUCt1-t2,ss (Area Under the Concentration-time Curve for the Unbound Sum Dabigatran in Plasma From Time Point t1 to Time Point t2, at Steady State) on Day 3 and Day 4|AUC(2-12),ss ((area under the concentration-time curve for the idarucizumab in plasma from time point 2 to 12 h )) on Day 3 and Day 4|2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h|PKS (presented values are those subjects from the PKS with evaluable observations for this endpoint)||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
671177|NCT01688830|Secondary|C1.92,ss, C2,ss, C2.5,ss, C6,ss, and C12,ss (Concentration of the Unbound Sum Dabigatran in Plasma at Steady State)|"Concentrations of unbound sum dabigatran in plasma after 1.92 to 12 h, at steady state of dabigatran, on Day 4 are presented.
The endpoint refers to unbound sum dabigatran at several time points. The intended pharmacodynamic effect of idarucizumab is to reduce the concentration of this measure to levels below the lower limit of quantification (BLQ). “BLQ” values are not considered in the calculation of descriptive statistics; and therefore bias the result. This is the reason for applying the 2/3 rule to obtain reliable results. 2/3 rule states that, Statistics of PK parameters are only estimated when at least 2/3 of the data are evaluable."|1.92 hours (h), 2 h, 2.5 h, 6 h and 12 h on Day 4|"Pharmadynamic set (PDS) : The PDS was used for all PD analyses and comprised all subjects in the TS who provided at least 1 evaluable predose and
1 on-treatment observation for calculating ratio (PD endpoint) and who had no important protocol violations relevant to the evaluation of PD."||ng/mL||Geometric Coefficient of Variation|Geometric Mean
671178|NCT01688830|Secondary|Aet1-t2,ss (Amount of Dabigatran Etexilate Eliminated in Urine From Time Point t1 to Time Point t2, at Steady State) on Day 3 and Day 4 for Sum Dabigatran|"Aet1-t2,ss (amount of dabigatran etexilate eliminated in urine from time point t1 to time point t2, at steady state) on Day 3 and Day 4
Ae(0-12h,ss) of sum dabigatran"|Intervals 0-2, 2-6, 6-10, 10-12 hours on Day 3 post dabigatran treatment and -2 to -0:05, -0:05 to 4, 4-8, 8-10, 10-12, 12-24, 24-48, 48-72 on Day 4 post Idarucizumab treatment|PKS (presented values are those subjects from the PKS with evaluable observations for this endpoint)||μg||Geometric Coefficient of Variation|Geometric Mean
671179|NCT01688830|Primary|Number of Subjects With Drug Related Adverse Events (AE)|Frequency of subjects with related adverse events (AE) by treatment|AEs occurring until end of follow-up (Up to 3 months after last drug administration)|Treated set||participants|||Number
671180|NCT01688830|Secondary|Aet1-t2 (Amount of Idarucizumab Eliminated in Urine From Time Point t1 to Time Point t2)|"Aet1-t2 (amount of idarucizumab eliminated in urine from time point t1 to time point t2)
Ae(0-7h) is presented for dose groups with 1 h infusion and Ae(0-4h) is presented for dose groups with 5 min infusion."|Up to 7 hours|PKS (presented values are those subjects from the PKS with evaluable observations for this endpoint)||μmol||Geometric Coefficient of Variation|Geometric Mean
671181|NCT01688830|Secondary|AUC0-inf (Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity) for Idarucizumab|AUC0-inf (area under the concentration-time curve from time 0 extrapolated to infinity) for idarucizumab|-2 hours(h), -0.5h, 0h, 2min(m), 5m, 10m, 15m,30m, 45m, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h|PKS (presented values are those subjects from the PKS with evaluable observations for this endpoint)||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
671182|NCT01688830|Secondary|Tmax (Time From Dosing to Maximum Measured Concentration) for Idarucizumab|tmax (time from dosing to maximum measured concentration) for idarucizumab|-2 hours(h), -0.5h, 0h, 2min(m), 5m, 10m, 15m,30m, 45m, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h|PKS (presented values are those subjects from the PKS with evaluable observations for this endpoint)||hours||Full Range|Median
671183|NCT01688830|Secondary|Cmax (Maximum Measured Concentration) for Idarucizumab|Cmax (maximum measured concentration) for idarucizumab|-2 hours(h), -0.5h, 0h, 2min(m), 5m, 10m, 15m,30m, 45m, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h|Pharmacokinetic set (PKS) comprises of all subjects (with evaluable observations) in the TS who provided at least 1 PK endpoint and had no important protocol violations relevant to the evaluation of PK and additionally for Part 2 and 3 had no emesis with onset at or before twice the median tmax of dabigatran.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
671184|NCT01688726|Secondary|Non Invasive Tear Film Break-up-time (NIBUT)|NIBUT was measured prior to eyedrop instillation (baseline) and at 60, 90, and 120 minutes post eyedrop instillation. The time elapsed between eye opening after a blink and the appearance of the first dark spot within the tear film as observed with a specialized illumination source was recorded. A higher number represents a lengthening in the tear film break up time and greater perceived ocular comfort.|Month 1|This analysis population includes all randomized participants with at least 1 evaluable post-treatment efficacy assessment. Here, n represents the number of participants with non-missing values at the specific time point for each arm group, respectively.||seconds||Standard Deviation|Mean
671185|NCT01688726|Secondary|High Contrast logMAR Time Controlled Visual Acuity (TCVA)|TCVA (functional visual performance) was measured with both eyes together under controlled lighting, contrast and temporal conditions using the OTG computerized vision testing system prior to eyedrop instillation (baseline) and at 60, 90, and 120 minutes post eyedrop instillation with the subject's up-to-date vision correction in place. TCVA is measured in logarithm of the minimum angle of resolution (logMAR), with logMAR acuity of 0.0 considered normal distance eyesight. A negative logMAR value denotes better visual acuity.|Month 1|This analysis population includes all randomized participants with at least 1 evaluable post-treatment efficacy assessment.||logMAR||Standard Deviation|Mean
671186|NCT01688726|Primary|Mean Bulbar Conjunctival Staining|The conjunctival staining present in the bulbar area was evaluated 120 minutes post eyedrop instillation using a slit lamp with digital image capture and lissamine green strips. Staining coverage as a percentage of the exposed bulbar conjunctiva is reported. A lower percentage in staining area represents a better outcome.|Month 1|This analysis population includes all randomized participants with at least 1 evaluable post-treatment efficacy assessment.||percentage of staining||Standard Deviation|Mean
671187|NCT01688635|Secondary|Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp Procedure|Gtot was the total glucose infusion over the clamp duration and was used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations were held constant after the administration of LY2963016 or US-approved Lantus by adjusting the exogenous glucose infusion rate. Data presented were adjusted by the body weight.|30 minutes predose up to 24 hours postdose in all treatment periods|Full analysis set (FAS): All randomized participants who received at least 1 dose of study drug and had evaluable pharmacodynamic data to calculate Gtot. Participants were analyzed based on the treatment they received.||milligrams/kilogram (mg/kg)||Geometric Coefficient of Variation|Geometric Mean
671188|NCT01688635|Secondary|Maximum Glucose Infusion Rate (Rmax)|Rmax is the maximum infusion rate of glucose administered intravenously needed to maintain target blood glucose level and is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of LY2963016 or US-approved Lantus by adjusting the exogenous glucose infusion rate. Data presented were adjusted by the body weight.|30 minutes predose up to 24 hours postdose in all treatment periods|Full analysis set (FAS): All randomized participants who received at least 1 dose of study drug and had evaluable pharmacodynamic data to calculate Rmax. Participants were analyzed based on the treatment they received.||milligrams/kilograms/minute (mg/kg/min)||Geometric Coefficient of Variation|Geometric Mean
671189|NCT01688635|Primary|Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY2963016 and US-Approved Lantus||30 minutes predose up to 24 hours postdose in all treatment periods|Full analysis set (FAS): All randomized participants who received at least 1 dose of study drug and had evaluable PK data to calculate Cmax. Participants were analyzed based on the treatment they received||picomoles/liter (pmol/L)||Geometric Coefficient of Variation|Geometric Mean
671190|NCT01688635|Primary|Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY2963016 and US-Approved Lantus|The AUC from time 0 to 24 hours (AUC0-24) of LY2963016 and US-Approved Lantus was measured.|30 minutes predose up to 24 hours postdose in all treatment periods|Full analysis set (FAS): All randomized participants who received at least 1 dose of study drug and had evaluable PK data to calculate AUC(0-24). Participants were analyzed based on the treatment they received.||picomoles*hour/liter (pmol*h/L)||Geometric Coefficient of Variation|Geometric Mean
671191|NCT01688609|Secondary|Number of Participants With Treatment-Related Toxicities||Up to 12 weeks after completion of study treatment|||participants|||Number
671192|NCT01688609|Secondary|EGFR-mutation Status of Tumors and Changes in the Ratio of Phosphorylated to Nonphosphorylated HER2, EGFR, ERK, Akt, and the Ki67 and TUNEL Indices Before and After Treatment|The EGFR mutation status will be a binary variable (yes vs. no), and the phosphorylation status of HER2 and EGFR will be a ratio variable (0-100%). The CART method to identify cut-off points for the phosphorylation ratio of molecules of interest will be used, such that ratios above the cut-off point will be considered “high phosphorylation” and ratios below the cut-off point will be considered “low phosphorylation.”|From baseline to 24 weeks|The study was not able to determine the cut off value of total and phorylated RTK ratio. Assays were not reliable. Data of EGFR mutations were not collected.|||||
671193|NCT01688609|Secondary|Cellular Response Rate, Defined as Patients With an Epithelial Phenotype Having Eradication of CTCs; Patients With a Mesenchymal Phenotype Having Eradication of Tumor Cells; Patients With a Mesenchymal Phenotype Converting to an Epithelial Phenotype|Cellular response will be documented and calculated for rate in all patients.|Up to 18 weeks|||participants|||Number
671194|NCT01688609|Primary|Number of Participants With Pathological Complete Response (pCR)|The point estimate of the pCR rate will be calculated for all patients. pCR is defined as the abscence of invasive cancer in the breast and regional lymph nodes following neoadjuvant chemotherapy.|Up to 12 weeks|||Participants|||Count of Participants
671195|NCT01688609|Primary|Expression of ALDH1 and CD44v Change in the Binary Biomarkers From Baseline to 6 Weeks and 18 Weeks|For biomarkers ALDH1 and CD44v, the change in the proportions of CD44v-positive (CD44v+) tumor cells and ALDH1-positive (ALDH1+) tumor cells in tumor tissue from baseline to 6 weeks and 18 weeks time points were determined for each patient. For biomarker change, changes in the binary biomarkers between time points were assessed using McNemar’s test in all patients and separately in patients with and without pCR.|From baseline to 18 weeks|||Participants|||Count of Participants
671196|NCT01688336|Other Pre-specified|Correlation of Tumor Markers (Ca19-9, CEA) With Outcomes (RR, DCR, PFS, and OS).|Tumor markers (Ca19-9, CEA) will be measured at baseline, every eight weeks and at end of treatment, and will be correlated with outcomes resectability response (RR),disease control rate (DCR), progression free survival (PFS) and overall survival (OS).|Up to 3 years|Data were not collected|||||
671197|NCT01688336|Secondary|Rate of Resectability (RR)|Rate of resectability will be evaluated by determining the percentage of patients who were initially deemed to have ULA or borderline resectable (BR) disease and, following any period of treatment, were subsequently deemed to have resectable disease and undergo surgical resection. The denominator will reflect all patients with ULA or BR disease.|Up to 3 years|||percentage of patients||95% Confidence Interval|Number
671198|NCT01688336|Secondary|Disease Control Rate (DCR)|Disease control rate will be measured by the percentage of patients with responses (CR) and partial responses (PR) and stable disease (SD), per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI and/or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (POD); Complete Response (CR), Disappearance of all target lesions.|Up to 3 years|||percentage of patients||95% Confidence Interval|Number
671199|NCT01688336|Secondary|Objective Response Rate|"All patients who have received at least one cycle of treatment will be evaluated. Disease will be evaluated per Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1) for target lesions and assessed by CT and/or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.
Patients who drop out of the study prior to disease evaluation will not be evaluable for response unless the patient undergoes radiologic evaluation or their disease progresses clinically."|Up to 3 years|||percentage of patients||95% Confidence Interval|Number
671200|NCT01688336|Secondary|Progression Free Survival (PFS)|Progression free survival will be measured from D1 of treatment until evidence of tumor progression (including clinical deterioration related to the underlying pancreatic cancer, as assessed by the investigator) or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Patients that are lost to follow-up will be censored|the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years|||Months||95% Confidence Interval|Median
671201|NCT01688336|Secondary|Overall Survival for Borderline Resectable Patients|All patients who receive at least Day 1 of FOLFIRINOX treatment will be evaluable and followed up for up to 3 years for the outcome of overall survival (OS)|Up to 3 years|||Months||95% Confidence Interval|Median
671202|NCT01688336|Primary|Median Overall Survival (OS) of FOLFIRINOX in Patients With Unresectable Locally Advanced (ULA) Pancreatic Cancer|All patients who receive at least Day 1 of FOLFIRINOX treatment will be evaluable and followed up for up to 3 years for the primary outcome of overall survival (OS).|Up to 3 years|Patients with unresectable locally advanced pancreatic cancer.||months||95% Confidence Interval|Median
671203|NCT01688310|Other Pre-specified|Adverse Events|Intraoperative and post-operative adverse events, such as bleeding, hematoma, and infection|1 yr|||participants|||Number
671204|NCT01688310|Secondary|Cosmetic Result|Cosmetic result evaluated by classification of scar line as regular (straight without any irregularity), irregular (not completely straight), or scalloped (with a wavy appearance).|Within 6 weeks after surgery|||participants|||Number
671205|NCT01688310|Secondary|Overall Patient Satisfaction|Patient satisfaction evaluated with patient satisfaction questionnaire using five point Likert scale.|Within 6 weeks after surgery|||participants|||Number
671206|NCT01688310|Secondary|Pain Experienced|Pain experienced during and after the procedure using Pain Questionnaire with 10 point pain scale (0 signifies no pain and 10 signifies maximal pain)|2 days after surgery|||units on 10 point pain scale||Standard Deviation|Mean
671207|NCT01688310|Secondary|Direct Costs|the cost of labor, supplies and equipment|Within 6 weeks after surgery||||||
671208|NCT01688310|Secondary|Time Required for Healing|Time required for healing|Within 6 weeks after surgery|||percentage of participants|||Number
671209|NCT01688310|Secondary|Difficulty in Learning and Performing Technique|"Evaluated by doctor survey, 5 point Likert scale:
Gomco technique is much easier
Gomco technique is easier
Neutral
Open surgical technique is easier
Open surgical technique is much easier"|1 year|||units on Likert scale||Full Range|Median
671210|NCT01688310|Primary|Intraoperative Duration|Time it takes for procedure from first manipulation of tissue under local anesthesia to dressing.|1 year|All participants||Min||Standard Deviation|Mean
671223|NCT01688050|Primary|Device Success|Technical success (successful access, deployment, and patency of the Zenith® TX2® Low Profile Endovascular Graft), and freedom from the following: device collapse, type I or type III endoleaks requiring reintervention, and conversion to open surgical repair.|30 days|One patient had device compression (counted as a failure conservatively although the compression was not consistent with collapse of the proximal end of the device) and one patient had a site-reported Type I endoleak requiring secondary intervention.||participants|||Number
671224|NCT01688050|Primary|Aortic Injury-related Mortality|Any death determined by the independent clinical events committee to be causally related to the initial implant procedure, secondary intervention, or rupture of the transected aorta.|30 days|||participants|||Number
671225|NCT01688050|Primary|All-cause Mortality||30 days|One death was adjudicated as unrelated by the Clinical Events Committee (CEC).||participants|||Number
671226|NCT01687790|Secondary|Sensitivity of MBI. Sensitivity in This Case is Defined as the Number of True Positives/ Total Number of Positive Pathology Results.|Reported are the number of indeterminate lesions with marked, moderate, or mild uptake and positive pathology results (true positives).|1 year|Analysis population included the number of indeterminate lesions that had positive pathology results.||lesions|||Number
671227|NCT01687790|Primary|Specificity of MBI. Specificity is Defined as the Number of True Negatives/ Total Number of Negative Pathology Results.|The number of indeterminate lesions with negative MBI uptake and negative/benign pathology results.Reported are number of indeterminate lesions with negative MBI uptake and negative/benign pathology results (true negatives).|1 year|Analysis population included the number of indeterminate lesions that had negative/benign pathology results.||lesions|||Number
671228|NCT01687478|Secondary|Mean Change From Baseline to 8 Week Endpoint in the Abnormal Involuntary Movement Scale (AIMS)|AIMS is a 12-item scale. Items 1 to 8 are rated on a 5-point scale ranging from 0 (no dyskinetic movements) to 4 (severe dyskinetic movements). Item 9 assesses the participant’s incapacitation due to abnormal movements, and item 10 assesses the participant's awareness of the abnormal movements and associated distress. Items 9 and 10 are rated on 5-point scales ranging from 0 (none or no awareness) to 4 (severe or aware, severe distress). Items 11 and 12 are yes/no questions regarding the dental status of the participant. The total score is the sum of the scores for the 12 items and the possible total score ranges from 0 to 42. A higher total score is indicative of more severe dyskinetic movements.|Baseline, 8 Weeks|All randomized participants who received at least one dose of study drug.||units on a scale||Standard Deviation|Mean
671229|NCT01687478|Secondary|Mean Change From Baseline to 8 Week Endpoint in the Barnes Akathisia Scale (BAS)|BAS is used to rate observable, restless movements of drug induced akathisia and the subjective awareness of restlessness and any distress associated with the akathisia. The BAS consists of the following 3 items: an objective assessment of akathisia symptoms; a subjective assessment of the patient’s awareness of inner restlessness; and a global clinical assessment of akathisia. The first two items are rated on a 4-point scale ranging from 0 (no abnormal movements or the absence of inner restlessness) to 3 (severe akathisia or the awareness of intense compulsion to move most of the time). The last item, the global clinical assessment of akathisia, is rated on a 5-point scale, ranging from 0 (no evidence of akathisia) to 5 (severe akathisia). Total BAS score ranges from 0 to 14 with a higher score representing worse results.|Baseline, 8 Weeks|All randomized participants who received at least one dose of study drug.||units on a scale||Standard Deviation|Mean
671230|NCT01687478|Secondary|Percentage of Participants Who Achieve Remission Based on MADRS Total Score ≤10 at 8 Weeks|The MADRS consists of 10 items with each item rated on a scale ranging from 0 to 6. Fixed descriptors appear along the scale for each item at points 0, 2, 4, and 6, to standardize the gradation of response along the scale. The MADRS total score is the sum of the 10 items; therefore the possible MADRS total score ranges from 0 to 60. A higher MADRS total score indicates a greater severity of depressive symptoms.|Baseline, 8 Weeks|All randomized participants who had a baseline and at least one post-baseline MADRS total score measurement.||Percent of participants|||Number
671231|NCT01687478|Secondary|Percentage of Participants Who Achieve a Response Based on a ≥50% Reduction From Baseline in MADRS Total Score|The MADRS total score is the sum of the 10 items; therefore the possible MADRS total score ranges from 0 to 60. A higher MADRS total score indicates a greater severity of depressive symptoms.|Baseline,8 Weeks|All randomized participants who had a baseline and at least one post-baseline MADRS total score measurement.||Percent of participants|||Number
671232|NCT01687478|Secondary|Mean Change From Baseline to 8 Week Endpoint in the Sheehan Disability Scale (SDS)|SDS consists of 3 items (work/school, social life/leisure activities, and family life/home responsibilities). Total scores range from 0 to 30 with higher values indicating greater disruption. Individual Item scores range from 0 to 10 with higher values indicating greater disruption.|Baseline, 8 Weeks|All randomized participants.||Units on a scale||Standard Error|Mean
671233|NCT01687478|Secondary|Mean Change From Baseline to 8 Week Endpoint in the Short-Form 36 Health Survey (SF-36)|SF-36, version 2 is a generic participant-rated questionnaire and consists of 36 questions covering the following 8 health domains (subscales): general health, role limitations because of physical problems, role limitations due to emotional problems, physical functioning, bodily pain, mental health, social functioning, and vitality. Each subscale is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. Two summary scores, the physical component summary (PCS) and the mental component summary (MCS) were constructed based on the eight SF-36 subscales. Both PCS and MCS range from 0-100 with higher scores indicating better health or functioning.|Baseline, 8 Weeks|All randomized participants.||units on a scale||Standard Deviation|Mean
671234|NCT01687478|Secondary|Mean Change From Baseline to 8 Week Endpoint in the Simpson-Angus Scale (SAS)|SAS scale consists of 10 items including 7 items that address bradykinesia-rigidity and additional single items for tremor, glabellar tap,and salivation. Each item represents a specific physical condition and is rated on a 5-point category rating scale ranging from 0 (complete absence of the condition) to 4 (the condition is present to an extreme degree).The total score is obtained by adding the scores for the 10 individual items making the maximum possible score is 40. Higher scores are indicative of more severe Parkinsonian-type symptoms.|Baseline, 8 Weeks|All randomized participants who received at least one dose of study drug.||units on a scale||Standard Deviation|Mean
671563|NCT01683604|Secondary|Percentage of Participants on Tocilizumab Monotherapy (8 mg/Kg) at Baseline and at Month 6||Baseline, Month 6|FAS population. n= participants with available data at the specified visit.||percentage of participants|||Number
671235|NCT01687478|Secondary|Mean Change From Baseline to 8 Week Endpoint in Clinical Global Impressions-Severity of Depression (CGI-S) Scale|CGI-S scale measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). The LS mean (LSM) change from baseline, standard error was derived using MMRM methodology with factors for treatment , Pooled Investigator , Visit , (Baseline + Treatment)*Visit.|Baseline, 8 Weeks|Participants in the FAS population: all randomized participants who had a baseline and at least one post-baseline MADRS total score measurement.||Units on a scale||Standard Error|Least Squares Mean
671236|NCT01687478|Primary|Mean Change From Baseline to 8 Week Endpoint in Montgomery-Äsberg Depression Rating Scale (MADRS)|The MADRS total score is the sum of the 10 items; therefore the possible MADRS total score ranges from 0 to 60. A higher MADRS total score indicates a greater severity of depressive symptoms. Least square means (LSM) change from baseline, standard error was derived using mixed model repeated measures (MMRM) methodology with factors for treatment, Pooled Investigator, Visit, (Baseline + Treatment)*Visit.|Baseline, 8 Weeks|Participants in the full analysis set (FAS) population: all randomized participants who had a baseline and at least one post-baseline MADRS total score measurement.||Units on a scale||Standard Error|Least Squares Mean
671237|NCT01687283|Secondary|Steady-state Plasma Pharmacokinetics of Fluticasone Propionate Inhalation Solution-area Under the Plasma Concentration-time Curve for the Dose Interval [AUC (0-τ)]|AUC (0-τ) was defined as the area under the plasma concentration-time curve for the dose interval. Blood PK samples were taken on Visit 3 (Day 14±2) pre-dose, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h and 12h post dose from participants. Blood sample for PK analysis, obtained within 72 hours of last dose.|Pre-dose, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h and 12h post dose at Week 2|Pharmacokinetic population. Only those participants available at the indicated time points were analyzed.||Picogram hours per milliliter (pg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
671238|NCT01687283|Secondary|Steady-state Plasma Pharmacokinetics of Fluticasone Propionate Inhalation Solution-maximum Observed Plasma Concentration (Cmax)|Cmax was defined as maximum observed plasma concentration. Blood PK samples were taken on Visit 3 (Day 14±2) pre-dose, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h and 12h post dose from participants. Blood sample for PK analysis, obtained within 72 hours of last dose.|Pre-dose, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h and 12h post dose at Week 2|Pharmacokinetic population. Only those participants available at the indicated time points were analyzed.||picogram per milliliter (pg/mL)||Geometric Coefficient of Variation|Geometric Mean
671239|NCT01687283|Secondary|Steady-state Plasma Pharmacokinetics of Fluticasone Propionate Inhalation Solution- Time to Maximum Observed Plasma Concentration (Tmax)|Tmax is defined as the time to maximum observed plasma concentration. Blood Pharmacokinetic (PK) samples were taken on Visit 3 (Day 14±2) pre-dose, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h and 12h post dose from participants. Blood sample for PK analysis, obtained within 72 hours of the last dose.|Pre-dose, 0.5 hour (h), 1h, 2h, 3h, 4h, 6h, 8h and 12h post dose at Week 2|Pharmacokinetics population included all participants whose PK samples were obtained and analyzed. Only those participants available at the indicated time points were analyzed.||Hour||Geometric Coefficient of Variation|Geometric Mean
671240|NCT01687283|Secondary|Change of Clinical Lung Function Measurement Forced Expiratory Volume in One Second (FEV1) From Baseline Over 12 Weeks|FEV1 as a measure of lung function assessment was measured at Week 2, 4, 8 and 12. FEV1 measures were performed electronically by spirometry. The highest of three technically acceptable measurements was recorded. FEV1 was measured prior to study drug administration and any rescue salbutamol use. Baseline value was the assessment at Visit 2.Change from baseline was calculated as the value at the specific time point minus baseline value.|Baseline and at Week 2, 4, 8 and 12|Intent-to-treat population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).||Litres||Standard Error|Least Squares Mean
671241|NCT01687283|Secondary|Median Number of Times Rescue Medication Use Over 12 Weeks|Participants recorded the number of inhalations of rescue salbutamol inhalation aerosol used during the day and night. The baseline value was Visit 2 assessment and was derived from the last 7 days of the daily diary prior to the randomization. The analysis only included participants who had at least 2 days of non-missing numbers of times rescue medication (including zero) after randomization.|Up to week 12|Intent-to-treat population. Only those participants available at the indicated time points were analyzed.||Number of Inhalations||Full Range|Median
671242|NCT01687283|Secondary|Mean Change in Percentage of Rescue-free 24-hour Periods From Baseline Over 12 Weeks|While calculating rescue-free 24-hour periods, the 24-hour period was only set to be “rescue free” if responses to both the morning and evening, assessments indicated no use of rescue medication. If there were symptoms in either the morning or the evening then that 24-hour period was set to as “not symptom free”. Similarly, if there was rescue medication use in either the morning or the evening, then that 24-hour period was set to as “not rescue free”. The Baseline value was Visit 2 assessment and was derived from the last 7 days of the daily diary prior to the randomization. The value provided in outcome measure data is a consolidated value over Weeks 1 to 12.|Baseline and over 12 weeks|Intent-to-treat population. Only those participants available at the indicated time points were analyzed.||Percentage of rescue -free 24-hours||Standard Error|Least Squares Mean
671243|NCT01687283|Secondary|Median Day-time and Night-time Symptom Scores Per Participant Over 12 Weeks|Participants recorded day-time symptom score every day in the morning and evening at bedtime before taking any rescue or study medication and before PEF measurement, using 6 point scale on Diary Card indicating 0 = No symptoms during the day and 5 =Symptoms so severe that participant could not go to work or perform normal daily activities. Night time symptoms were scored while waking in the morning on a scale of 0 (no symptoms) to 4 (severe). The value provided in outcome measure data is a consolidated value over Weeks 1 to 12.|Over 12 Weeks|Intent-to-treat population. Only those participants available at the indicated time points were analyzed.||Score on Scale||Full Range|Median
671269|NCT01687244|Secondary|Incidence of High Grade-Recurrence-Free Survival at 9 Months (270 Days).|All patients were evaluated 9 Months (270 Days) after the start of treatment for recurrence of high grade disease by cytology, cystoscopy, and biopsy if clinically indicated. Patients that we free of High-Grade disease recurrence received a final dose. Data are presented as the number and percent of patients with High-Grade disease recurrence.|270 Days|All patients that received a dose at Day 180 were assessed for High-Grade disease by cytology, cystoscopy, and biopsy if clinically indicated.||Participants|||Count of Participants
671244|NCT01687283|Secondary|Mean Change in Percentage of Symptom-free 24-hour Periods From Baseline Over 12 Weeks|While calculating symptom-free 24-hour periods, a given 24-hour period was set to be “symptom free” only if the participant’s responses to both the morning and evening assessments indicated no symptoms. The Baseline value was Visit 2 assessment and was derived from the last 7 days of the daily diary prior to the randomization. Change from Baseline was calculated as the difference between the value of the endpoint at the time point of interest and the baseline value. The value provided in outcome measure data is a consolidated value over Weeks 1 to 12.|Baseline (Visit 2) and over 12 Weeks|Intent-to-treat population. Only those participants available at the indicated time points were analyzed.||Percentage of symptom-free 24-hour||Standard Error|Least Squares Mean
671245|NCT01687283|Secondary|Mean Change of Evening PEF From Baseline Over 12 Weeks|The peak expiratory flow (PEF) is a person's maximum speed of expiration, A peak flow meter was issued to participants at Visit 1 to measure the evening PEF prior to study drug and rescue medication. The best of three attempts was recorded by the participants in the diary cards. Baseline value was the assessment at Visit 2. The raw and change from baseline in daily PM PEF averaged over the 12-weeks treatment period.|Baseline (Visit 2) and up to Week 12|Intent-to-treat population. Only those participants available at the indicated time points were analyzed.||Litres/Minute||Standard Error|Least Squares Mean
671246|NCT01687283|Primary|Change From Baseline (Day 1 of Trt Period/Visit 2) in AM PEF Over 12 Weeks in Per Protocol Population|The peak expiratory flow (PEF) is a person's maximum speed of expiration, A peak flow meter was issued to participants at Visit 1 to measure the morning PEF prior to study drug and rescue medication. The best of three attempts was recorded by the participants in the diary cards. Baseline value was the assessment at Visit 2. The raw and change from baseline in daily AM PEF averaged over the 12-week treatment period The mean value was considered missing if less than 4 days were recorded in the baseline week prior to randomization or if less than 4 days are recorded after randomization. Analysis was performed using analysis of covariance (ANCOVA) model.|Baseline (Visit 2) and up to Week 12|Per protocol population. This population comprised of all participants in the intent-to-treat Population who did not have any protocol violations which could impact treatment effect.Only those participants available at the specified time points were analyzed.||Litres/Minute||Standard Error|Least Squares Mean
671247|NCT01687283|Primary|Change From Baseline (Day 1 of Treatment Period/Visit 2) in Morning Peak Expiratory Flow (AM PEF) Over 12 Weeks in Intent-to-treat Population|The peak expiratory flow (PEF) is a person's maximum speed of expiration, A peak flow meter was issued to participants at Visit 1 to measure the morning PEF prior to study drug and rescue medication. The best of three attempts was recorded by the participants in the diary cards. Baseline value was the assessment at Visit 2. The raw and change from baseline in daily AM PEF averaged over the 12-week treatment period The mean value was considered missing if less than 4 days were recorded in the baseline week prior to randomization or if less than 4 days are recorded after randomization. Analysis was performed using analysis of covariance (ANCOVA) model. Abbreviations used in statistical analysis section: standard deviation (SD) and significance (sig)|Baseline (Visit 2) and up to Week 12|Intent-to-treat population. Only those participants available at the specified time points were analyzed.||Litres/Minute||Standard Error|Least Squares Mean
671248|NCT01687270|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as on-treatment virologic failure or virologic relapse.
On-treatment virologic failure: HCV RNA < LLOQ during treatment with subsequent detectable HCV RNA while continuing treatment
Virologic relapse: HCV RNA < LLOQ at last observed on-treatment HCV RNA measurement and HCV RNA ≥ LLOQ after stopping treatment (2 consecutive HCV RNA measurements or last available HCV RNA measurement)"|Up to Posttreatment Week 24|Full Analysis Set||percentage of participants|||Number
671249|NCT01687270|Secondary|HCV RNA and Change From Baseline at Weeks 2, 4, and 8||Baseline; Weeks 2, 4, and 8|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
671250|NCT01687270|Secondary|Percentage of Participants With HCV RNA < LLOQ at Weeks 12 and 24||Weeks 12 and 24|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants|||Number
671251|NCT01687270|Secondary|Percentage of Participants With Sustained Virologic Response (SVR) at 4, 24, and 48 Weeks After Discontinuation of Therapy (SVR4, SVR24, and SVR48)|SVR4, SVR 24, and SVR 48 were defined as HCV RNA < LLOQ 4, 24, and 48 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 4, 24, and 48|Full Analysis Set||percentage of participants|||Number
671252|NCT01687270|Primary|Percentage of Participants Who Discontinue Study Drug Due to an Adverse Event||Baseline to Week 24|Safety Analysis Set||percentage of participants|||Number
671253|NCT01687270|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, < 25 IU/mL) 12 weeks following the last dose of study drug.|Posttreatment Week 12|Full Analysis Set: participants were enrolled and received at least one dose of study medication.||percentage of participants|||Number
671254|NCT01687257|Secondary|Change From Baseline in Model for End Stage Liver Disease (MELD) Scores|"MELD scores, used to assess prognosis and suitability for transplant, are calculated based on laboratory values only and can range from 6 to 40, with higher scores indicating greater disease severity. Data are presented as improvement, no change, or worsening in MELD scores at Week 24 (Observation) and Posttreatment Week 4 (SOF+RBV groups).
Improvement in MELD score was defined as having a baseline MELD score of 11-15 or 16-20 that changed to 0-10, or a baseline MELD score of 16-20 that changed to 11-15; no change in MELD score was defined as having no change in score group (0-10, 11-15, or 16-20) from baseline; and worsening in MELD score was defined as having a baseline MELD score of 0-10 that changed to 11-15 or 16-20, or a baseline MELD score of 11-15 that changed to 16-20.
Baseline values were the last available values on or prior to first dose date of any study drug."|Baseline; Week 24 (Observation) and Posttreatment Week 4 (SOF+RBV)|Participants who were randomized to the study with available data were analyzed.||percentage of participants|||Number
671270|NCT01687244|Secondary|Incidence of High Grade-Recurrence-Free Survival at 6 Months (180 Days).|All patients were evaluated 6 Months (180 Days) after the start of treatment for recurrence of high grade disease by cytology, cystoscopy, and biopsy if clinically indicated. Patients that we free of High-Grade disease recurrence received another dose. Data are presented as the number and percent of patients with High-Grade disease recurrence.|180 Days|All patients receiving a dose at 90 Days were assessed at 180 Days for High-Grade disease by cytology, cystoscopy, and biopsy if clinically indicated.||Participants|||Count of Participants
671255|NCT01687257|Secondary|Change From Baseline in Child-Pugh-Turcotte (CPT) Score|"CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease. Data are presented as improvement, no change, or worsening in CPT scores at Week 24 (Observation) and Posttreatment Week 4 (SOF+RBV groups).
Improvement in CPT score was defined as having a decrease in CPT score from baseline, no change in CPT score was defined as having no change in CPT score from baseline, and worsening in CPT score was defined as having an increase in CPT score from baseline.
Baseline values were the last available values on or prior to first dose date of any study drug."|Baseline; Week 24 (Observation) and Posttreatment Week 4 (SOF+RBV)|Participants who were randomized to the study with available data were analyzed.||percentage of participants|||Number
671256|NCT01687257|Secondary|Change From Baseline in Hepatic Venous Pressure Gradient (HVPG) at End of Treatment|HVPG closely reflects the degree of portal hypertension in patients with cirrhosis. The end of treatment for the Observation group was defined as the end of the observation period. The treatment period for Group 2 was defined as the end of the observation period to the end of the treatment. Baseline values were the last available values on or prior to first dose date of any study drug.|Baseline; Week 24 (Observation) and Week 48 (SOF+RBV)|Participants who were randomized to the study with available data at baseline and end of observation or end of treatment were analyzed.||mmHg||Standard Deviation|Mean
671257|NCT01687257|Secondary|Percentage of Participants Experiencing Viral Relapse|Viral relapse was defined as HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement.|Up to Posttreatment Week 24|Participants who were randomized and received at least 1 dose of study drug with available data were analyzed.||percentage of participants|||Number
671258|NCT01687257|Secondary|Percentage of Participants Experiencing On-Treatment Virologic Failure|"On-treatment virologic failure was defined as:
Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)"|Up to 48 weeks|Participants who were randomized and received at least 1 dose of study drug.||percentage of participants|||Number
671259|NCT01687257|Secondary|Percentage of Participants With SVR at 4, 24, and 48 Weeks After Discontinuation of Therapy (SVR4, SVR24, and SVR48)|SVR4, SVR24, and SVR48 were defined as HCV RNA < LLOQ at 4, 24, and 48 weeks after stopping study treatment, respectively.|Posttreatment Weeks 4, 24, and 48|Participants who were randomized and received at least 1 dose of study drug with available data were analyzed.||percentage of participants|||Number
671260|NCT01687257|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment. For the Observation/SOF+RBV group, SVR12 during the observational period was defined as HCV RNA < LLOQ for 12 consecutive weeks, any time during the observational period.|Posttreatment Week 12 (SOF+RBV) and up to 24 weeks (Observation)|Participants who were randomized to the study.||percentage of participants|||Number
671261|NCT01687244|Secondary|Number of Patients With Elevated Levels of Anti-Adenovirus Type 5 Antibodies in Serum.|The levels of serum anti-adenovirus type 5 antibodies as measured by ELISA were determined in all patients on the initial day of dosing (Pre-Dose Day 1), at Day 12, and for patients that were free of High-Grade disease recurrence and received subsequent subsequent doses at Day 180 (pre-dose), Day 270 (pre-dose), and Day 360 or Withdrawal.|360 Days|Data are reported at Number of Patients with a Positive Titer.||Participants|||Count of Participants
671262|NCT01687244|Secondary|Number of Patients With Elevated Levels of Anti-IFN alpha2b Antibodies in Serum|The levels of serum anti-IFN alpha2b antibodies as measured by ELISA were determined in all patients on the initial day of dosing (Pre-Dose Day 1), at Day 12, and for patients that were free of High-Grade disease recurrence and received subsequent doses at Day 180 (pre-dose), Day 270 (pre-dose), and Day 360 or Withdrawal.|360 Days|Data are reported at Number of Patients with a Positive Titre.||Participants|||Count of Participants
671263|NCT01687244|Secondary|Number of Patients With Elevated IFN alpha2b Protein Levels in Urine|The levels of urine IFN alpha2b protein as measured by ELISA were measured in all patients on the initial day of dosing Day 1 (pre-dose) and at Day 2, Day 4, Day 12, and for patients that did not have recurrence of HGD and received a second dose at Day 91 (pre-dose), Day 92, Day 94, and Day 103.|103 Days|Data are reported as the number of patients with elevated levels of IFN alpha2b levels in urine.||Participants|||Count of Participants
671264|NCT01687244|Secondary|Number of Patients With Elevated IFN alpha2b Protein Levels in Serum|The levels of serum IFN alpha2b protein as measured by ELISA were determined in all patients on the initial day of dosing (Pre-Dose Day 1), at Day 2, Day 4, Day 12, and for patients that were free of High-Grade disease recurrence and received subsequent doses at Day 91 (pre-dose), Day 92, Day 94, Day 103, Day 180 (pre-dose), Day 270 (pre-dose), and Day 360 or Withdrawal.|360 Days|Data are reported as the number of patients with increased levels of IFN alpha2b protein in serum.||Participants|||Count of Participants
671265|NCT01687244|Secondary|Number of Patients With Elevated Levels of Viral Vector in Urine|The level of viral vector as measured by qPCR in urine was determined in all patients on the initial day of dosing Day 1 (pre-dose) and at Day 2, Day 4, Day 12, and for patients that were free of High-Grade disease recurrence and received a second dose at Day 91 (pre-dose), Day 92, Day 94, and Day 103.|103 Days|Data are reported as number of patients demonstrating increased levels of viral vector by qPCR in urine.||Participants|||Count of Participants
671266|NCT01687244|Secondary|Number of Patients With Elevated Levels of Viral Vector in Blood|The level of viral vector as measured by qPCR in blood was determined in all patients on the initial day of dosing Day 1 (pre-dose) and at Day 2, Day 4, Day 12, and for patients that were free of High-Grade disease recurrence and received a second dose at Day 91 (pre-dose), Day 92, Day 94, and Day 103.|103 Days|Data are reported as number of patients demonstrating viral vector by qPCR in blood.||Participants|||Count of Participants
671267|NCT01687244|Secondary|Overall Survival in All Patients.|Overall survival was defined as the number who survived from the first dose of rAd-IFN/Syn3 to the end of the primary assessment (360 Days) or Withdrawal.|360 Days|The data are presented as the number of patients who survived the study (360 Days). All patients were monitored for this endpoint.||Participants|||Count of Participants
671271|NCT01687244|Secondary|Incidence of High Grade Recurrence-Free Survival at 3 Months (90 Days).|All patients were evaluated 3 Months (90 Days) after the start of treatment for recurrence of high grade disease by cytology, cystoscopy, and biopsy if clinically indicated. Patients that we free of High-Grade disease recurrence received another dose. Data are presented as the number and percent of patients with High-Grade disease recurrence.|90 Days|All patients at 90 Days were assessed for High-Grade disease by cytology, cystoscopy, and biopsy if clinically indicated.||Participants|||Count of Participants
671272|NCT01687244|Secondary|Safety of rAd-IFN/Syn3|Treatment Emergent Adverse Events (AEs) for patients receiving study drug were described by NCI-CTCAE V4.03 terminology according to System Organ Class.|360 Days|||Participants|||Count of Participants
671273|NCT01687244|Primary|Incidence of High Grade-Recurrence Free Survival at 360 Days|Following the initial treatment, patients were clinically evaluated and re-treated at the Days 90, 180, and 270 time points, as outlined below. The decision to repeat treatment was determined by the clinical response observed following the previous treatment(s). Patients were assessed for High-Grade disease recurrence by cytology, cystoscopy and, if clinically indicated, biopsies were performed to obtain accurate staging. If no evidence of recurrence of High-Grade disease was detected, then a further dose of rAd-IFN/Syn3 was administered as maintenance therapy. Patients who had recurrence of High-Grade disease were withdrawn from treatment but were followed for survival and time to cystectomy. At 360 Days, a final efficacy evaluation was performed for patients receiving 4 doses of drug. This included cystoscopy, cytology, and biopsy.|360 Days|||Participants|||Count of Participants
671274|NCT01687218|Other Pre-specified|Problem Practices|To determine the prevalence of behavioral practices associated with anal intercourse that may affect microbicide use|27 weeks (three 8-week product use periods with 1-week washout periods between them)||||||
671275|NCT01687218|Other Pre-specified|Product Sharing|To determine the level of sharing of study products with non-participants and to assess with whom products are shared|27 weeks (three 8-week product use periods with 1-week washout periods between them)||||||
671276|NCT01687218|Other Pre-specified|Sexual Activity and Condom Use|To examine whether sexual activity or condom use varies by product used|27 weeks (three 8-week product use periods with 1-week washout periods between them)||||||
671277|NCT01687218|Other Pre-specified|Factors Associated With Adherence|To identify factors associated with product adherence and whether they differ by product used (FTC/TDF or TFV RG 1% gel) or regimen (daily use or RAI-associated use)|27 weeks (three 8-week product use periods with 1-week washout periods between them)||||||
671278|NCT01687218|Other Pre-specified|Correlation Between PK and Adherence|To assess correlation of PK with adherence measures|27 weeks (three 8-week product use periods with 1-week washout periods between them)||||||
671279|NCT01687218|Other Pre-specified|Mucosal Immunity|To characterize changes in mucosal immunity between baseline and the end of the daily FTC/TDF and TFV RG 1% gel product use|27 weeks (three 8-week product use periods with 1-week washout periods between them)||||||
671280|NCT01687218|Other Pre-specified|Pharmacodynamics|To characterize pharmacodynamic responses following oral and rectal exposure to antiretroviral drugs|27 weeks (three 8-week product use periods with 1-week washout periods between them)||||||
671281|NCT01687218|Secondary|Adherence|To evaluate and compare adherence to daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel. The Behavioral Research Working Group provided the final adherence estimate of the percentage of prescribed doses taken for each participant for each period based on participant self-report, staff estimates and PK testing results.|27 weeks (three 8-week product use periods with 1-week washout periods between them)|All secondary analyses are based on the data from evaluable participants||participants|||Number
671282|NCT01687218|Secondary|Pharmacokinetics|To compare systemic and local PK among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel|27 weeks (three 8-week product use periods with 1-week washout periods between them)||||||
671283|NCT01687218|Primary|Acceptability: Participant Self-report of Likelihood of Product Use if Shown to be Effective. N1-If This Product Provides Some Protection How Likely Would You be to Take it?|To evaluate and compare acceptability of daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel. Consistent with the acceptability endpoint of likelihood to use product in the future, a variable was created by combining Section N. Likelihood to Use Product in the Future of the MTN-017 Follow-up Behavioral Questionnaire questions 1A, 1B, and 1C. Categories 1 and 2 were combined and categories 3 and 4 were combined to create a dichotomous variable.|27 weeks (three 8-week product use periods with 1-week washout periods between them)|All primary analyses are based on the data from evaluable participants. Evaluable participants are those participants who were enrolled and not replaced, or were the final enrolled replacement participant for another enrolled participant who met the criteria for replacement.||participants|||Number
671284|NCT01687218|Primary|Acceptability: Participant Self-report of Ease of Use. I1-Overall How Easy or Difficult Was it to Use the Product?|To evaluate and compare acceptability of daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel. Consistent with the acceptability endpoint of ease of use, a variable was created to compare regimens. This variable combines questions 1A and 1BC from Section I. Ease of Use of the MTN-017 Follow-up Behavioral Questionnaire. Categories 1 and 2 were combined and categories 3 and 4 were combined to create dichotomous variables.|27 weeks (three 8-week product use periods with 1-week washout periods between them)|All primary analyses are based on the data from evaluable participants. Evaluable participants are those participants who were enrolled and not replaced, or were the final enrolled replacement participant for another enrolled participant who met the criteria for replacement.||participants|||Number
671285|NCT01687218|Primary|Acceptability: Participant Self-report of Liking the Product. H1-Overall How do You Feel About the Product You Used Recently?|To evaluate and compare acceptability of daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel. Consistent with the acceptability endpoint of liking the product, a variable was created by combining from Section H. Liking the Product of the MTN-017 Follow-up Behavioral Questionnaire question 1A and question 1BC. Categories 1 and 2 were combined and categories 3 and 4 were combined to create a dichotomous variable.|27 weeks (three 8-week product use periods with 1-week washout periods between them)|All primary analyses are based on the data from evaluable participants. Evaluable participants are those participants who were enrolled and not replaced, or were the final enrolled replacement participant for another enrolled participant who met the criteria for replacement.||participants|||Number
671286|NCT01687218|Primary|Safety: Grade 2 or Higher Adverse Events|Compare the safety profiles of daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel. Analysis of the primary endpoint of grade 2 or higher AEs was performed on only the evaluable participants based on the principle of intent-to-treat (ITT) whereby participants who were randomized were included in the analysis regardless of whether or not they received product in a given period (i.e, were lost to follow-up, or terminated early and/or were on a product hold).|27 weeks (three 8-week product use periods with 1-week washout periods between them)|Among the 187 evaluable participants. One participant was terminated before the Initiate Period visit of his/her Period 3 (Oral Tablet regimen period). Thus, this participant is removed from the analysis of the oral period regimen.||participants|||Number
671287|NCT01687114|Primary|Proanthocyanidin A2|proanthocyanidin A2 concentration in urine is determined using a LC-MS/MS method.|24-hour urine and morning spot urine|The subjects included 5 generally healthy premenopausal women, age 20-40 y, with a body mass index (BMI) ranging from 18.5 to 25 kg/m2. The specific operational criteria used to assess eligibility included: age, BMI, premenopausal status, not pregnant or planning to become pregnant.||ng/mg creatinine||Standard Deviation|Mean
671288|NCT01687101|Primary|Efficacy of STOPAIN in the Acute Treatment of Migraine|"To evaluate the efficacy of STOPAIN in the acute treatment of migraine as measured by Pain Freedom (headache pain intensity level equal to no pain) at 2 hours post dose using a four point numeric rating scale (0=no pain, 1= mild pain, 2=moderate pain, 3=severe pain)."|2 hours after the time of gel application|||units on a scale||Full Range|Mean
671289|NCT01687088|Primary|Comparison of UPSIT Scores Between Subjects and Controls at Two Time Points|"Migraineurs and controls will take the University of Pennsylvania Smell Identification Test (UPSIT) in the office. The UPSIT test is a series of 40 questions and the score is the number of questions answered correctly. Each question is multiple choice and must be answered. The number of correct answers regarding the smells being experienced is the subjects score. The higher the score the better the sense of smell. This allows groups to be compared. In this study after the first visit, migraineurs will be given the UPSIT test without a headache and then they will self-administer the UPSIT during a migraine attack day at home.
Age and sex matched controls will also take the first UPSIT in the office. They will take second UPSIT 2 weeks later at home."|Chronic migraineurs up to 12 months. Controls up to 2 weeks.|||UPSIT Score||Standard Error|Mean
671290|NCT01687036|Secondary|AE|18 AEs were recorded in 7 out of 10 patients. 3 AEs were definitely related to treatment and one AE was definitely device related. All patients recovered completely.|First patient - first visit: September 11, 2012; Last patient - last visit: March 26, 2013|||participants|||Number
671291|NCT01687036|Secondary|Cumulative Cryoablation Time|"Cryoablation time was defined as the cumulative duration of all cryoapplications in each single study patient.
Average cryoablation time was 114 min. 33 sec. (range 80 – 130 min.)."|First patient - first visit: September 11, 2012; Last patient - last visit: March 26, 2013|||minutes||Standard Deviation|Mean
671292|NCT01687036|Secondary|Fluoroscopy Time|"Fluoroscopy time was defined from introduction of the CoolLoop® catheter into the left atrium until removal of the CoolLoop® catheter from the left atrium after termination of the last cryo - application. Accumulated time using fluoroscopy during procedure time.
Average fluoroscopy time was 44 min. 01 sec. (range 17 min. 03 sec. – 59 min.)."|Treatment Duration|||minutes||Standard Deviation|Mean
671293|NCT01687036|Secondary|Procedure Time|Procedure time was defined from introduction of the CoolLoop® catheter into the left atrium until removal of the CoolLoop® catheter from the left atrium after termination of the last cryo-application.|Average procedure time: 251 min. 06 sec. (range 126 – 320 min.)|||minutes||Standard Deviation|Mean
671294|NCT01687036|Secondary|Clinical Efficacy of Catheter Ablation|During follow-up recurrence of AF was reported by the patient and documented by ECG in 8 patients (80%). 2 patients remained free of recurrences of AF.|First patient - first visit: September 11, 2012; Last patient - last visit: March 26, 2013|||participants|||Number
671295|NCT01687036|Secondary|Acute Efficacy of Catheter Ablation|Absolute percentage of PVs isolated with the CoolLoop® catheter.|Treatment Duration|||percentage of isolated PVs|||Number
671296|NCT01687036|Secondary|Feasibility of Catheter Ablation Measured by Number of Participants Treated With the AFreeze Cryoablation System.|Feasibility, defined by the ability to position the catheter in the proximal part in each of the pulmonary veins (PVs) using an over-the-wire technique, forming the cryo-applicator of the catheter to a loop by operating the catheter handle, positioning the loop at the wall of the PV antrum and delivering cryothermia.|Treatment Duration|||participants|||Number
671297|NCT01687036|Primary|Tolerability of Ablation Using the AFreeze Cryoablation System|"The primary study objective is assessed by recording all Adverse Events (AEs).
Primary endpoint: measurement of the following parameters:
- deformation of the catheter loop resulting in entrapment of the catheter in the heart and difficulties removing the catheter during visit 3 (treatment)."|Treatment Duration|||AE (device related)|||Number
671298|NCT01687036|Primary|Safety of Ablation Using the AFreeze Cryoablation System Consisting of the CoolLoop® Ablation Catheter, Its Steerable Sheath and the Cryoconsole Cryo-Caddy Assessed by Recording All Serious Adverse Events (SAEs)|"The primary study objective is assessed by recording all Serious Adverse Events (SAEs).
Primary endpoint: measurement of the following parameters:
deformation of the catheter loop resulting in entrapment of the catheter in the heart and difficulties removing the catheter during visit 3 (treatment).
phrenic nerve palsy during visit 3 (treatment).
onset and time course between visit 3 (treatment) and visit 5 (discharge) of death, pericardial tamponade, valve damage requiring surgery and hemorrhage requiring transfusion.
onset and time course between visit 3 (treatment) and visit 9 (final visit) of atrioesophageal fistula, sepsis, abscesses, endocarditis, stroke, transient ischemic attack, and PV stenosis requiring intervention."|3 months|||participants|||Number
671299|NCT01686932|Secondary|Number of Occurrence of Pre-defined ECG Findings During 4 Days of Continuous ECG Monitoring at Baseline and in the 8th Week of Periods 1 and 2|Number of Occurrence of pre-defined ECG findings during 4 days of continuous ECG monitoring at baseline and in the 8th week of Periods 1 and 2. ECG data were continuously recorded and analyzed over a period of 4 days simultaneously with continuous glucose monitoring. It assessed number of any Vertical Electric(al) Sounding (VES), number of 2 consecutive VES [couplets], and number of >3 consecutive VES [salves]|after 8 weeks Period 1 & Period 2|Full Analysis Set (FAS) included all patients that was treated with study medication.||number of occurrence||Standard Deviation|Mean
671300|NCT01686932|Secondary|Percentage Change From Baseline of Pro-insulin/C-peptide Ratios After 8 Weeks of Treatment Period 1 & Period 2|Percentage Change from baseline of pro-insulin/C-peptide ratios after 8 weeks of treatment Period 1 & Period 2 Higher pro-insulin / C-peptide ratios (expressing disproportional hyperproinsulinemia) may be associated with increasing beta cell dysfunction and more inefficient pro-insulin processing|Baseline, after 8 weeks Period 1 & Period 2|Full Analysis Set (FAS) included all patients that was treated with study medication.||Percentage Change||Standard Deviation|Mean
671301|NCT01686932|Secondary|Change From Baseline of Inflammatory Biomarkers Interleukin 6 (IL-6) After 8 Weeks of Treatment in Period 1 & Period 2|The inflammatory biomarkers IL-6 was assessed at baseline and after 8 weeks of treatment Period 1 & Period 2|Baseline, after 8 weeks Period 1 & Period 2|Full Analysis Set (FAS) included all patients that was treated with study medication.||pg/L||Standard Deviation|Mean
671302|NCT01686932|Secondary|Change From Baseline of Inflammatory Biomarkers High Sensitivity C-reactive Protein (hsCRP) After 8 Weeks of Treatment in Period 1 & Period 2|The inflammatory biomarkers hsCRP was assessed at baseline and after 8 weeks of treatment Period 1 & Period 2|Baseline, after 8 weeks Period 1 & Period 2|Full Analysis Set (FAS) included all patients that was treated with study medication.||mg/L||Standard Deviation|Mean
671303|NCT01686932|Secondary|Number of Participants With ECG Abnormalities Depending on Hypoglycemic Events After 8 Weeks of Treatment Period 1 & Period 2|ECG abnormalities are defined as either: • Occurrence of >30 ventricular extrasystoles (VES) per hour or • Occurrence of ≥2 consecutive VES (Couplets) or • Occurrence of ≥3 consecutive VES (Triplets) or • QT-time corrected for heart rate (QTc) >440 ms. after 8 weeks of treatment Period 1 & Period 2|after 8 weeks of treatment Period 1 & Period 2|Full Analysis Set (FAS) included all patients that was treated with study medication.||participants|||Number
671304|NCT01686932|Secondary|Glucose Fluctuations During the Day Under Vildagliptin Treatment Compared to Sitagliptin Treatment on Day 2 After 8 Weeks of Treatment Period 1 & Period 2|Glucose fluctuations are assessed by the mean amplitude of glycemic excursions (MAGE) and standard deviations (SD) (Service et al., 1970). on day 2 after 8 weeks of treatment Period 1 & Period 2|Day 2 after 8 weeks of treatment Period 1 & Period 2|Full Analysis Set (FAS) included all patients that was treated with study medication.||mmol/L||Standard Deviation|Mean
671305|NCT01686932|Secondary|Number of Severe Hypoglycemic Events During Vildagliptin Treatment Compared to Sitagliptin Treatment After 8 Weeks of Treatment in Period 1 and Period 2|Severe hypoglycemic events are defined as any episode requiring the assistance of another party or measured plasma glucose levels of <40 mg /dL. Assessed by self-monitored blood glucose (SMBG)After 8 weeks of treatment in Period 1 and Period 2|after 8 weeks Period 1 & Period 2|Full Analysis Set (FAS) included all patients that was treated with study medication.||severe hypoglycemic events|||Number
671306|NCT01686932|Secondary|Mean Amplitudes of Hypoglycemic Events (mmol/L) Measured With Continuous Glucose Monitoring (CGM) Over 4 Days After 8 Weeks of Treatment for Period 1 & Period 2|To evaluate by CGM measurement the grade of severity of hypoglycemia measured as the mean amplitude over 4 days after 8 weeks of treatment in Period 1 & Period 2|after 8 weeks Period 1 & Period 2|Full Analysis Set (FAS) included all patients that was treated with study medication.||mmol/L||Standard Deviation|Mean
671307|NCT01686932|Secondary|Mean Duration of Hypoglycemic Events (Min.) Measured With Continuous Glucose Monitoring (CGM) Over 4 Days After 8 Weeks of Treatment for Period 1 & Period 2|the mean duration of hypoglycemic events is detected by continuous glucose monitoring (CGM)measurement.|after 8 weeks for Period 1 & Period 2|Full Analysis Set (FAS) included all patients that was treated with study medication.||minutes||Standard Deviation|Mean
671308|NCT01686932|Secondary|Number of Hypoglycemic Events During Vildagliptin Treatment Compared to Sitagliptin Treatment.|Hypoglycemic events are defined as blood glucose values <70 mg/dL measured by a self-monitored blood glucose (SMBG) or continuous glucose monitoring (CGM) measurement regardless of any symptoms suggestive of low blood glucose.|after 8 weeks period 1 and Period 2|Full Analysis Set (FAS) included all patients that was treated with study medication.||number of hypoglycemic events|||Number
671309|NCT01686932|Primary|Hypoglycemic Profile of Vildagliptin Compared to Sitagliptin Over 4 Days After 8 Weeks of Treatment in Period 1 & 2|The hypoglycemic profile is defined as the area under the curve glucose-time profile obtained by continuous glucose monitoring Interstitial glucose values below 3.9 mmol/L (averaged over 5 minutes) were considered relevant for the estimation of the interstitial glucose AUC in the hypoglycemic range These AUC<3.9mmol/L/5min. values were summed up over 4 days (unit: mmol/L/4d) or over 24 hours at measurement Days 2, 3, 4, and 5 (unit: mmol/L/24h). Lower values for AUC reflect less intense hypoglycemia.|baseline and 0-24 hours post-dose on Days 2 to 5|Full Analysis Set (FAS) included all patients that was treated with study medication.||mmol/L/4d||Standard Deviation|Mean
671310|NCT01686828|Secondary|Changes in Adipose Tissue Gene Expression|We examined whether differences in lipoprotein lipase expression would be evident across study treatment groups. RNA was isolated from whole adipose tissue gene expression, and complementary DNA (cDNA) was synthesized from 1.5 ug of RNA per sample. Gene expression was measured by polymerase chain reaction (PCR) using predesigned TaqMan® Gene Expression Assays. Standard curves were included on each plate, so Ct values were converted to copy numbers of the target gene. Expression values were normalized to the geometric mean of the housekeeping genes phosphoglycerate kinase and 18s.|4 weeks|Subjects were included who had adipose tissue samples available from both baseline and week 4 (end-of-treatment) visits.||gene copy number per ng RNA||Standard Deviation|Mean
671311|NCT01686828|Secondary|Changes in Body Composition|Fat mass and lean mass were measured by dual energy X-ray absorptiometry (DEXA) at baseline and at the end of the 4 week treatment period|4 weeks|||kg||Standard Deviation|Mean
671312|NCT01686828|Primary|Insulin Sensitivity Quantified by Matsuda Index|Whole body insulin sensitivity as quantified by Matsuda Index at the end of the treatment period, calculated by the following equation: 10,000/square root of(FPG*FI)*(FPG+PG30*2+PG60*2+PG90*2+PG120)/8*(FPI+PI30*2+PI60*2+PI90*2+PI)/8). FPG=fasting plasma glucose level; FPI=fasting plasma insulin level; PG30,60,90, and 120=plasma glucose levels sampled at 30,60,90, and 120 minutes after oral glucose load; PI30,60,90, and 120=plasma insulin levels sampled at 30,60,90, and 120 minutes after the oral glucose load|4 weeks|Of the 53 subjects who attended the baseline study visit, 2 withdrew from the study and 1 was discontinued due to a protocol violation. 50 subjects completed the week 10 study visit. Of these, 5 subjects were excluded from the final analyses; 1 was found to have undiagnosed diabetes, and 4 subjects were excluded due to study drug non-adherence.||units on a scale||Inter-Quartile Range|Median
671313|NCT01686646|Secondary|Change From Baseline in Number of Incorrect and Missed Responses to DAT Cognitive Test|For the Divided Attention task, participants were required to respond on hearing the no. ‘8’ in a continuous stream of numbers through headphones or seeing a letter ‘s’ on screen. This was identified in the output file by a value of ‘8’ in ‘NUMBER’ column or ‘s’ in ‘LETTER’ column. If a subject responded incorrectly (pressed the response button at the wrong time), this was identified by a value of ‘-1’ in ‘CORRECT=1’ column. The number of incorrect responses was calculated as the total no. of records where ‘CORRECT=1’ had a value of ‘-1’. If the subject missed a target (failed to press the response button on hearing the no. ‘8’ or seeing the letter ‘s’), this was considered a missed response. The number of missed responses was calculated as the no. of records where there was a value of ‘8’ in ‘NUMBER’ column or ‘s’ in ‘LETTER’ column and a value of ‘0’ in the ‘CORRECT=1’ column.|Baseline, 60 minutes and up to 120 minutes post treatment administration|ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation.||incorrect and missed responses||Standard Error|Mean
671314|NCT01686646|Secondary|Change From Baseline in Mean Time of Accurate Responses to DAT Cognitive Test|The mean time of accurate responses was defined as the mean reaction time for the correct responses. For records with ‘1’ in the ‘CORRECT=1’ column, the mean time of accurate response was calculated as the summation of the response time values divided by number of records with ‘1’ in the ‘CORRECT=1’ column. The result was multiplied by 1000 to convert into milliseconds (msecs).|Baseline, 60 minutes and up to 120 minutes post treatment administration|ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation.||msec||Standard Error|Least Squares Mean
671315|NCT01686646|Secondary|Change From Baseline in Number of Valid Responses to Divided Attention Task (DAT) Cognitive Test|Auditory and visual attention of participants was evaluated using a validated Divided Attention task. Participants were required to respond whenever they heard the number ‘8’ in a continuous stream of numbers presented through headphones or saw a letter ‘s’ on the screen . This was identified in the output file by a value of ‘8’ in the ‘NUMBER’ column or by a value of ‘s’ in the ‘LETTER’ column. If the subject correctly responded to the target, this was identified by a value of ‘1’ in the ‘CORRECT=1’ column. The number of accurate responses was calculated as the total number of records where ‘CORRECT=1’ had a value of ‘1’.|Baseline, 60 minutes and up to 120 minutes post treatment administration|ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation.||Correct responses||Full Range|Median
671316|NCT01686646|Secondary|Change From Baseline in Number of Incorrect and Missed Responses to SAT Cognitive Test|For sustained auditory attention task, participants were required to respond on hearing the no. ‘8’ in a continuous stream of numbers through headphones. It was identified in output file by a value of ‘8’ in ‘NUMBER’ column. For sustained visual attention task, participants responded to letter ‘s’ every time it appeared in a continuous stream of letters presented on screen. This was identified in output file by a value of ‘s’ in ‘LETTER’ column. If a subject responded incorrectly (pressed the response button at the wrong time), it was identified by a value of ‘-1’ in ‘CORRECT=1’ column. The no. of incorrect responses was calculated as total no. of records where ‘CORRECT=1’ had a value of ‘-1’. The no. of missed responses (when subject failed to press the response button on hearing the number ‘8’ or seeing the letter ‘s’), was calculated as the no. of records where there was a value of ‘8’ in ‘NUMBER’ column or ‘s’ in the ‘LETTER’ column and a value of ‘0’ in the ‘CORRECT=1’ column.|Baseline, 60 minutes and up to 120 minutes post treatment administration|ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation.||incorrect and missed responses||Standard Error|Mean
671317|NCT01686646|Secondary|Change From Baseline in Mean Time of Accurate Responses to SAT Cognitive Task|The mean time of accurate responses was defined as the mean reaction time for the correct responses. For records with ‘1’ in the ‘CORRECT=1’ column, the mean time of accurate response was calculated as the summation of the response time values divided by number of records with ‘1’ in the ‘CORRECT=1’ column. The result was multiplied by 1000 to convert into milliseconds (msecs).|Baseline, 30 minutes and up to 60 minutes post treatment administration|ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation.||msec||Standard Error|Least Squares Mean
671318|NCT01686646|Secondary|Change From Baseline in Number of Accurate Responses to Sustained Attention Tasks (SAT) Cognitive Test|Auditory and visual attention of participants was evaluated using a validated Sustained Attention task. For the sustained auditory attention task, participants were required to respond whenever they heard the number ‘8’ in a continuous stream of numbers presented through headphones. This was identified in the output file by a value of ‘8’ in the ‘NUMBER’ column. For the sustained visual attention task, participants were required to respond to the letter ‘s’ every time it appeared in a continuous stream of letters presented on a screen. This was identified in the output file by a value of ‘s’ in the ‘LETTER’ column. If the subject correctly responded to the target, this was identified by a value of ‘1’ in the ‘CORRECT=1’ column. The number of accurate responses was calculated as the total number of records where ‘CORRECT=1’ had a value of ‘1’.|Baseline, 60 minutes and up to 120 minutes post treatment administration|ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation.||Correct responses||Full Range|Median
671325|NCT01686633|Secondary|Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 12-week Treatment Period|Asthma symptoms were recorded in a daily eDairy by the participants every day in the morning and evening before taking any rescue or study medication and before the peak expiratory flow measurement. A 24-hour (hr) period in which a participant’s responses to both the morning and evening assessments indicated no symptoms was considered to be symptom free. The Baseline value was derived from the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 12-week treatment period minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment.|Baseline and Weeks 1-12|ITT Population. Only those participants available at the specified time points were analyzed.||Percentage of symptom-free 24-hr periods||Standard Error|Least Squares Mean
671564|NCT01683604|Secondary|Percentage of Participants by Reason for Choice of Monotherapy at Baseline||Baseline up to Month 6|Analysis was not performed as the data was not collected on case report form.|||||
671319|NCT01686646|Secondary|Change From Baseline in Number of Inaccurate and Missed Responses to RVIP Cognitive Task|The no. of inaccurate responses to RVIP was determined from cognitive function computerised output. Participants monitored a series of single numbers (0-9) appearing in the centre of screen. They responded to consecutive sequences of 3 odd or even numbers by pressing the corresponding response button. This was identified in the output file by a value of ‘1’ in the ‘TARGET=1’ column. If a subject responded incorrectly to stimuli (pressed the response button at the wrong time), this was identified by a value of ‘-1’ in the ‘CORRECT=1’ column. The no. of incorrect responses was calculated as the total no. of records where ‘CORRECT=1’ had a value of ‘-1’. If the subject missed a target (failed to press the response button within 600 msecs of being presented with a string of 3 consecutive even or odd numbers), this was considered a missed response and was calculated as the no. of records where there was a value of ‘1’ in the ‘TARGET=1’ column and a value of ‘0’ in the ‘CORRECT=1’ column.|Baseline, 60 minutes and up to 120 minutes post treatment administration|ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation.||inaccurate and missed responses||Standard Error|Mean
671320|NCT01686646|Secondary|Change From Baseline in Mean Time of Accurate Responses to RVIP Cognitive Task|The mean time of accurate responses was defined as the mean reaction time for the correct responses. For records with ‘1’ in the ‘CORRECT=1’ column, the mean time of accurate response was calculated as the summation of the response time values divided by number of records with ‘1’ in the ‘CORRECT=1’ column. The result was multiplied by 1000 to convert into milliseconds (msecs).|Baseline, 60 minutes and upto 120 minutes post treatment administration|ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation.||milliseconds (msec)||Full Range|Median
671321|NCT01686646|Secondary|Change From Baseline in Number of Accurate Responses to RVIP Cognitive Test|The RVIP assessed the performance of visual attention mechanisms in remaining vigilant to periodically occurring events. The number of accurate responses to RVIP task was determined from the cognitive function computerised output. Participants monitored a series of single numbers (0-9) appearing in the centre of the screen. During the RVIP task, participants responded to consecutive sequences of three odd or three even numbers by pressing the corresponding response button as quickly and accurately as possible. This was identified in the output file by a value of ‘1’ in ‘TARGET=1’ column. Also, the response time (in seconds) was recorded in the ‘RT’ column. If the subject correctly responded to the target, this was identified by a value of ‘1’ in the ‘CORRECT=1’ column. The number of accurate responses was calculated as the total number of records where ‘CORRECT=1’ had a value of ‘1’. The test lasted approximately 9 minutes and number of accurate responses to stimulus was calculated.|Baseline to 120 minutes post treatment administration|ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation.||Correct responses||Standard Error|Least Squares Mean
671322|NCT01686646|Primary|Change From Baseline in Number of Accurate Responses to Rapid Visual Information Processing (RVIP) Cognitive Test|The RVIP assessed the performance of visual attention mechanisms in remaining vigilant to periodically occurring events. The number of accurate responses to RVIP task was determined from the cognitive function computerised output. Participants monitored a series of single numbers (0-9) appearing in the centre of the screen. During the RVIP task, participants responded to consecutive sequences of three odd or three even numbers by pressing the corresponding response button as quickly and accurately as possible. This was identified in the output file by a value of ‘1’ in ‘TARGET=1’ column. Also, the response time (in seconds) was recorded in the ‘RT’ column. If the subject correctly responded to the target, this was identified by a value of ‘1’ in the ‘CORRECT=1’ column. The number of accurate responses was calculated as the total number of records where ‘CORRECT=1’ had a value of ‘1’. The test lasted approximately 9 minutes and number of accurate responses to stimulus was calculated.|Baseline to 60 minutes post treatment administration|Intent to Treat (ITT) population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation.||Correct responses||Standard Error|Least Squares Mean
671323|NCT01686633|Secondary|Change From Baseline in Daily Evening (PM) PEF Averaged Over the 12-week Treatment Period|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use and each morning. The best of three measurements was recorded. Change from Baseline (defined as the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily PM PEF over the 12-week treatment period minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment.|Baseline and Weeks 1-12|ITT Population. Only those participants available at the specified time points were analyzed.||Liters per minute||Standard Error|Least Squares Mean
671324|NCT01686633|Secondary|Change From Baseline in Daily Morning (AM) Peak Expiratory Flow (PEF) Averaged Over the 12-week Treatment Period|Peak Expiratory Flow (PEF) is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use and each morning. The best of three measurements was recorded. Change from Baseline (defined as the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily AM PEF over the 12-week treatment period minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment.|Baseline and Weeks 1-12|ITT Population. Only those participants available at the specified time points were analyzed.||Liters per minute||Standard Error|Least Squares Mean
671337|NCT01686568|Primary|Insulin Sensitivity by Hyperinsulinemic-euglycemic Clamp at Baseline and 6 Month Follow up|A 2-stage insulin clamp will be performed with titration of dextrose to maintain euglycemia. D2 glucose will be infused to evaluate hepatic glucose production at baseline and in response to insulin. Hyperinsulinemic-euglycemic clamp technique: The plasma insulin concentration is acutely raised and maintained by a continuous infusion of insulin. Meanwhile, the plasma glucose concentration is held constant at basal levels by a variable glucose infusion. When the steady-state is achieved, the glucose infusion rate (GIR) equals glucose uptake by all the tissues in the body and is therefore a measure of tissue insulin sensitivity.|Baseline, after 6 months of treatment|||mg/kg FFM/min||Standard Error|Mean
671326|NCT01686633|Secondary|Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods During the 12-week Treatment Period|The number of inhalations of rescue albuterol/salbutamol inhalation aerosol used during the day and night was recorded by the participants in a daily electronic diary (eDiary). A 24-hour (hr) period in which a participant’s responses to both the morning and evening assessments indicated no use of rescue medication was considered to be rescue free. The Baseline value was derived from the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 12-week treatment period minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment.|Baseline and Weeks 1-12|ITT Population. Only those participants available at the specified time points were analyzed.||Percentage of rescue-free 24-hr periods||Standard Error|Least Squares Mean
671327|NCT01686633|Secondary|Change From Baseline in Clinic Visit Trough FEV1 at the End of the 12-week Treatment Period|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is defined as a pre-dose FEV1 measurement taken at a clinic visit while still on-treatment. Change from Baseline in trough FEV1 at the end of the 12-week treatment period was defined using the 24-hour post-dose serial FEV1 measurement taken at the Week 12 clinic visit. Change from Baseline was calculated as the Week 12 trough FEV1 value minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline trough FEV1, region, sex, age, and treatment. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement at scheduled clinic visits was used to impute the missing measurements.|Baseline and Week 12|ITT Population. Only those participants with non-missing covariates and post-Baseline FEV1 data were analyzed.||Liters||Standard Error|Least Squares Mean
671328|NCT01686633|Primary|Change From Baseline in Weighted Mean Forced Expiratory Volume in One Second (FEV1) Over 0 to 24 Hours Post-dose at the End of the 12-week Treatment Period|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. The weighted mean was calculated from the pre-dose FEV1 (within 30 minutes prior to dosing) and post-dose FEV1 measurements at 5, 15, and 30 minutes and at 1, 2, 3, 4, 5, 12, 16, 20, 23, and 24 hours on Day 84/Week 12. At each time point, the highest of three technically acceptable measurements was recorded. Change from Baseline was calculated as the weighted mean of the 24-hour serial FEV1 measures on Day 84/Week 12 minus the Baseline value. Baseline was the pre-dose FEV1 measurement value obtained at Visit 3. The analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of Baseline FEV1, region, sex, age, and treatment.|Baseline and Week 12|Intent-to-Treat (ITT) Population: all participants randomized to treatment, who received at least one dose of the study medication. Only those participants with non-missing covariates and Week 12 weighted mean data were analyzed.||Liters||Standard Error|Least Squares Mean
671329|NCT01686568|Post-Hoc|EPA and DHA Concentrations in Adipose Tissue|Post hoc analyses were conducted to test whether EPA and DHA concentrations in subcutaneous abdominal adipose tissue in response to intervention explained variation in outcome measures of adipose tissue lipolysis insulin sensitivity and inflammatory markers post-intervention.|approximately after 6 months of treatment|||percentage of total free fatty acid||Standard Error|Mean
671330|NCT01686568|Post-Hoc|EPA and DHA Concentrations in Plasma|Post hoc analyses were conducted to test whether EPA and DHA concentrations in plasma in response to intervention explained variation in outcome measures of adipose tissue lipolysis insulin sensitivity and inflammatory markers post-intervention.|approximately after 6 months of treatment|||percentage of total free fatty acid||Standard Error|Mean
671331|NCT01686568|Secondary|Macrophage Crown-like Structures|Macrophages surrounding dying or dead adipocytes form crown-like structures (CLSs). One week after the pancreatic clamp study, participants were provided a standardized meal before an overnight fast. The next morning an abdominal adipose tissue biopsy was collected, and the samples were analyzed for adipocyte size. Immunohistochemistry was used to assess the number of crown-like structures per 10 images.|approximately after 6 months of treatment|||crown-like structures per 10 images||Inter-Quartile Range|Median
671332|NCT01686568|Secondary|Immunohistochemistry Assessments of Macrophage Burden|One week after the pancreatic clamp study, participants were provided a standardized meal before an overnight fast. The next morning an abdominal adipose tissue biopsy was collected, and the samples were analyzed for adipocyte size. Immunohistochemistry was used to assess macrophage burden (total (CD68), M1 (CD14) and M2 (CD206) macrophages per 100 adipocytes).|approximately after 6 months of treatment|||macrophages per 100 adipocytes||Standard Deviation|Mean
671333|NCT01686568|Secondary|Senescent Cells|Tissue burden of senescent cells, which was measured by staining for senescence-associated B-galactosidase activity and expressed as the number per 100 nucleated positive cells.|approximately after 6 months of treatment|||number positive cells/100 total cells||Standard Deviation|Mean
671334|NCT01686568|Secondary|Insulin Concentration Needed to Suppress Palmitate Appearance Rates (IC50(Palmitate)f)|Sensitivity of adipose tissue lipolysis to insulin suppression, was calculated as the insulin concentration needed to suppress palmitate appearance rates (ie, flux) by 50% (IC50(palmitate)f).|approximately after 6 months of treatment|The number of subjects analyzed for this outcome measure for the placebo arm was 8 instead of 9. One subject did not have blood drawn for this outcome measure.||µU/mL||Inter-Quartile Range|Median
671335|NCT01686568|Secondary|Mitochondrial Function Determined by Muscle Biopsy at Baseline and 6 Month Follow up|Measurements of oxygen consumption in isolated mitochondria will be performed using a polarographic oxygen electrode.|Baseline, after 6 months of treatment|||pmol/s/mg tissue||Standard Error|Mean
671336|NCT01686568|Secondary|Beta Cell Function From Insulin Secretion Following Ingestion of a Mixed Meal at Baseline and 6 Month Follow up|Following consumption of a mixed meal, beta cell function will be evaluated from serial measurements of C-peptide. C-peptide was measured using a two-side immunometric assay using electrochemiluminescence detection.|baseline, after 6 months of treatment|||nmol/L||Standard Error|Mean
671338|NCT01686503|Secondary|Baseline Polio Neutralizing Antibody Titers|serum polio neutralizing antibody titers prior to the vaccine booster|first visit|||antibody titers||95% Confidence Interval|Geometric Mean
671339|NCT01686503|Primary|Post Booster Polio Neutralizing Antibody Titers|Blood will be drawn at baseline and 4-6 weeks after receiving the vaccine booster dose. It will be spun down, and the serum frozen and stored at -80 degrees celsius. After all the participants have completed the study, all of the serum will be tested for polio neutralizing antibody titers.|4-6 weeks after receiving the vaccine|||antibody titers||95% Confidence Interval|Geometric Mean
671343|NCT01686451|Other Pre-specified|Comparison of XueZhiKang With Simvastatin of Physical Activity Level|At baseline and week 4, we estimated physical activity level by short version of international physical activity questionnaire (IPAQ) with categorical score ranged from low to high. The higher score was meaning of lower physical activity level.|Measured at baseline and week 4|||participants|||Number
671344|NCT01686451|Primary|Comparison Between XueZhiKang and Simvastatin on Fatigue Scores|At baseline and week 4, the fatigue score was assessed by a fatigue questionnaire named as Fatigue Assessment Scale (FAS) which used 10-item fatigue measure with the fatigue score ranged from 10-50. The higher score was meaning of higher level of fatigue.|Measured at baseline and week 4|||units on a scale||Standard Deviation|Mean
671345|NCT01686451|Secondary|Treatment Efficacy|Treatment efficacy was estimated on the basis of triglyceride (TG), total cholesterol (TC), high-density lipoprotein-cholesterol (HDL-C), as well as LDL-C levels obtained at baseline and week 4.|Measured at baseline and week 4|||mmol/L||Standard Deviation|Mean
671346|NCT01685996|Secondary|Nicotine Withdrawal Symptom Severity|Total Score from the Minnesota Nicotine Withdrawal Questionnaire (MNWQ), assessed at weekly visits. The MNWQ is a commonly-used 12-item Likert scale self-report measure of nicotine symptoms. Individual symptoms were rated from 0 (none) to 4 (severe) for each item and the Total score range was 0 - 48. Ratings were collected once weekly during study visits.|Past 24 hours|||units on a scale||Standard Deviation|Mean
671347|NCT01685996|Primary|Percent Participants Abstinent From Smoking During Study Weeks 7-10|Biochemically-verified continuous smoking abstinence during weeks 7-10 of the study.|weeks 7-10|||Participants|||Count of Participants
671348|NCT01685983|Primary|Percentage of Participants With Prostate-specific Antigen (PSA) Response|The PSA response was evaluated according to Prostate-Specific Antigen Working Group (PSAWG) criterion, which is, greater than or equal to 50 percent decrease in PSA from Baseline during the study, which would be subsequently confirmed by a measurement that is at least 4 or more weeks after initial documentation of PSA response.|Baseline, Month 4|Analysis population included all participants who received at least 1 dose of abiraterone acetate.||Percentage of participants|||Number
671349|NCT01685983|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|up to 15 months|Analysis population included all participants who received at least 1 dose of abiraterone acetate.||Participants|||Number
671350|NCT01685983|Secondary|Dehydroepiandrosterone (DHEA) Sulfate||Baseline up to 15 months|"Analysis population included all participants who received at least 1 dose of abiraterone acetate. n signifies those participants who were evaluated for this measure at the specified time point."||micromol per liter||Full Range|Median
671351|NCT01685983|Secondary|Serum Testosterone|Median baseline testosterone concentration was reported at baseline.|Baseline up to 15 months|"Analysis population included all participants who received at least 1 dose of abiraterone acetate. n signifies those participants who were evaluated for this measure at the specified time point."||nanomole per liter||Full Range|Median
671352|NCT01685983|Secondary|Percentage of Participants With Objective Radiographic Response|Percentage of participants with radiographic objective response is defined as the percentage of participants with complete response (CR) or partial response (PR) as best overall response based on reconciled radiographic disease assessment according to RECIST Version 1.0. The CR is disappearance of all lesions. The PR is at least 30 percent decrease in sum of the longest diameter of target lesions or persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.|up to 15 months|Radiographic response-evaluable population included all participants who received at least 1 dose of abiraterone acetate, and had baseline and at least 1 on treatment tumor assessment.||Percentage of participants|||Number
671353|NCT01685983|Secondary|Time to PSA Progression|Time to PSA progression was measured as the time interval from the date of the first dose to the date of PSA progression as defined in the protocol-specific PSAWG criteria. For participants who have achieved a greater than or equal to (>=) 50% decrease from the baseline PSA, assessment of time to disease progression is when the PSA has increased 50% above the nadir and at a minimum of 5 nanogram/mililiter (ng/mL). For participants without a PSA decrease of this magnitude or without a decrease, the time for progression is calculated at the time a 25% increase from baseline PSA has been achieved.|up to 15 months|Analysis population included all participants who received at least 1 dose of abiraterone acetate.||Days||95% Confidence Interval|Median
671354|NCT01685983|Secondary|Overall Survival|Overall survival is defined as the time interval from the date of the first dose to the date of death.|up to 5 years|Analysis population included all participants who received at least 1 dose of abiraterone acetate.||Days||95% Confidence Interval|Median
671355|NCT01685801|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|Adverse events (AEs) that started (or increased in severity) from first dose of study drug through completion of Follow-up were considered TEAEs, with exception that if an AE started during a Washout Period and was beyond 14 days from last dose date of preceding cycle, AE was considered as a “Washout Period” AE, and hence not TEAE. A TEAE was attributed to treatment in which it started or to the treatment in second cycling period of previous Crossover Period if it started during a Washout Period. SAE: medical event or condition, which falls into any of following categories, regardless of its relationship to study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Data was to be reported by drug treatment for double-blind crossover period (Cycle 1 up to Washout Period 2) and open-label period.|From first dose of study drug through completion of follow-up visit (up to 26 weeks)|Safety set included all participants who received at least 1 dose of study drug. Here, number of participants analyzed signifies participant evaluable for this outcome measure.||participants|||Number
671356|NCT01685801|Secondary|Open-label Period: Absolute Change From Open-label Baseline In Weight at Day 57|Data was to be reported for overall participants and as per genotype (residual function mutation and mRNA splice site mutation).|Open-label Baseline, Open-label Day 57|"FAS population. Here, number of participants analyzed signifies participant evaluable for this outcome measure and n signifies participants who were evaluable for the specified category."||kilograms (kg)||Standard Deviation|Mean
671357|NCT01685801|Secondary|Open-label Period: Absolute Change From Study Baseline In Sweat Chloride at Day 57|Sweat samples were collected using an approved Macroduct (Wescor, Logan, Utah) collection device. A volume of greater than or equal to (>=) 15 microliter was required for determination of sweat chloride. Data was to be reported for overall participants and as per genotype (residual function mutation and mRNA splice site mutation).|Study Baseline, Open-label Day 57|"FAS population. Here, number of participants analyzed signifies participant evaluable for this outcome measure and n signifies participants who were evaluable for the specified category."||millimole per liter (mmol/L)||Standard Deviation|Mean
671358|NCT01685801|Secondary|Open-label Period: Absolute Change From Open-label Baseline In Lung Clearance Index (LCI) at Day 57|LCI is a measure of ventilation inhomogeneity that is derived from a multiple-breath washout test. The LCI was calculated as the number of lung volume turnovers (cumulative expired volume divided by the functional residual capacity [FRC]) required to reduce end-tidal concentration of an inert gas to 1/40th of the starting value. Data was to be reported for overall participants and as per genotype (residual function mutation and mRNA splice site mutation).|Open-label Baseline, Open-label Day 57|"FAS population. Here, number of participants analyzed signifies participant evaluable for this outcome measure and n signifies participants who were evaluable for the specified category."||ratio||Standard Deviation|Mean
671359|NCT01685801|Secondary|Open-label Period: Absolute Change From Open-label Baseline In Percent Predicted Forced Expiratory Volume In 1 Second (FEV1) at Day 57|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, and height). The Hankinson standard was used for male participants 18 years and older and female participants 16 years and older. The Wang standard was used for male participants aged 12 to 17 years and for female participants aged 12 to 15 years. Data was to be reported for overall participants and as per genotype (residual function mutation and mRNA splice site mutation).|Open-label Baseline, Open-label Day 57|"FAS population. Here, number of participants analyzed signifies participant evaluable for this outcome measure and n signifies participants who were evaluable for the specified category."||Percent predicted of FEV1||Standard Deviation|Mean
671360|NCT01685801|Secondary|Cycle 1 and Cycle 2: Absolute Change From Cycle Baseline In Lung Clearance Index (LCI) After 2 Weeks of Treatment|LCI is a measure of ventilation inhomogeneity that is derived from a multiple-breath washout test. The LCI was calculated as the number of lung volume turnovers (cumulative expired volume divided by the functional residual capacity [FRC]) required to reduce end-tidal concentration of an inert gas to 1/40th of the starting value. Data was to be reported for each cycle (Cycle 1 and Cycle 2) and as per drug treatment. Data was to be reported for each cycle (Cycle 1 and Cycle 2) and as per drug treatment, for overall participants and as per genotype (residual function mutation and mRNA splice site mutation).|Cycle 1 baseline, Cycle 1 Day 15 (for Cycle 1 reporting arms); Cycle 2 baseline, Cycle 2 Day 15 (for Cycle 2 reporting arms)|"FAS population. Here, number of participants analyzed signifies participant evaluable for this outcome measure and n signifies participants who were evaluable for the specified category in each arm, respectively."||ratio||Standard Deviation|Mean
671361|NCT01685801|Primary|Cycle 1 and Cycle 2: Absolute Change From Cycle Baseline In Percent Predicted Forced Expiratory Volume In 1 Second (FEV1) After 2 Weeks of Treatment|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, and height). The Hankinson standard was used for male participants 18 years and older and female participants 16 years and older. The Wang standard was used for male participants aged 12 to 17 years and for female participants aged 12 to 15 years. Data was to be reported for each cycle (Cycle 1 and Cycle 2) and as per drug treatment, for overall participants and as per genotype (residual function mutation and mRNA splice site mutation).|Cycle 1 baseline, Cycle 1 Day 15 (for Cycle 1 reporting arms); Cycle 2 baseline, Cycle 2 Day 15 (for Cycle 2 reporting arms)|"Full analysis set (FAS) population. Here, number of participants analyzed signifies participant evaluable for this outcome measure and n signifies participants who were evaluable for the specified category in each arm, respectively."||Percent predicted of FEV1||Standard Deviation|Mean
671362|NCT01685684|Secondary|Change in Level of Physical Disability Using the Roland Morris Disability Questionnaire (RMDQ)|The Roland Morris Disability Questionnaire (RMDQ) is a self-administered questionnaire designed to assess physical disability caused by lower back pain. The RMDQ contains 24 sentences that subjects used to describe themselves when they have back pain. The RMDQ score is the total number of items checked which is from a minimum of 0 to a maximum of 24; the greater the score the grater the physical disability due to lower back pain.|Randomization Baseline and Week 12|The RMDQ was analyzed and presented as a change from Randomization Baseline to Week 12. Subjects' scores from Early Discontinuation visits were not included in this analysis.||units on a scale||Standard Deviation|Mean
671363|NCT01685684|Secondary|Changes in Quality of Life|Short Form 12 Question Health Survey version 2 (SF-12v2) is a self-report survey designed to measure general quality of life from the subject's point of view. The survey includes eight domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. Physical (PCS) and mental component scores (MCS) are also calculated. Positive values indicate improvement from randomization baseline to Week 12.|Randomization Baseline through Week 12|||units on a scale||Standard Error|Mean
671364|NCT01685684|Secondary|Patient Global Impression of Change (PGIC)|"The PGIC scale is a self-reported assessment that assesses a subject's impression of his/her change in activity limitations, symptoms, emotions, and the overall quality of life as they relate to his/her painful condition. The 7-point PGIC assessment includes very much improved, improved, a little improved, no change, a little worse, worse, and very much worse."|Screening Baseline through Week 12|||participants|||Number
671365|NCT01685684|Secondary|Rescue Medication Use by Dosage|Evaluation of the total amount of rescue medication used (by milligrams of dosage per day, dosage per week, and total dosage while on-study)|Randomization Baseline through Week 12|||milligrams||Standard Deviation|Mean
671366|NCT01685684|Secondary|Rescue Medication Usage by Dose|Evaluation of the total amount of rescue medication used (number of doses per day, number of doses per week, and total number of doses while on-study)|Randomization Baseline through Week 12|||doses||Standard Deviation|Mean
671565|NCT01683604|Secondary|Time to Restoration of Initial Dosing Regimen||Baseline up to Month 6|Analysis was not performed due to inadequate data available for this outcome measure.|||||
671368|NCT01685684|Secondary|Percent Reduction in Pain Intensity for Responders|Includes the cumulative distribution of subjects with an improvement in pain intensity, as measured on an 11-point PI-NRS scale, and the proportion of responders with at least 30% and at least 50% reduction in pain intensity.|Screening Baseline through Week 12|||participants|||Number
671369|NCT01685684|Secondary|Time-to-exit From the Study for All Causes|Survival analysis. Measure type indicated as 'Number' below represents 25% quartile, given that the median was not reached. These data are consistent with subject completion in the Participant Flow module.|Randomization Baseline through Week 12|||Days||95% Confidence Interval|Number
671370|NCT01685684|Primary|Change in Average Pain Intensity Measured by the Change in Pain Intensity-Numeric Rating Scale (PI-NRS) Scores From Randomization Baseline to Week 12 of the Double-blind Maintenance Phase|The PI-NRS is an 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain).|Randomized Baseline through Week 12|One subject is missing all Average Weekly Pain Scores after Screening in the Oxycodone DETERx treatment group. This subject has been excluded from the analysis.||units on a scale||Standard Error|Mean
671371|NCT01685606|Secondary|To Evaluate the Rate of Dose Limiting Toxicities of HLA Haploidentical Peripheral Blood Pheresed Cellular Infusions.||30 days and 16 weeks after infusion|||participants|||Number
671372|NCT01685606|Primary|Overall Response Rate of Cellular Immune Therapy With HLA Haploidentical Peripheral Blood Pheresed Cells in Patients With Relapsed/Refractory Hematological Malignancies.|"Criteria for AML and ALL (adapted from Cheson et al.20)
Complete remission (CR) is defined as the presence of all of the following
Peripheral blood
o No leukemic blasts present.
No extramedullary findings of leukemia or disappearance of such (i.e. CNS or soft tissue involvement)
Bone marrow
Cellularity >20% with baseline maturation.
No Auer rods
Less than 5% blast cells.
Complete blood counts and bone marrow normalization criteria must be met within one week of each other. Hematopoeitic recovery is an ANC > 1.0 x 109/L and platelet count > 100x109/L. No specific hemoglobin or hematocrit level is specified but the patient must be transfusion free.
Complete remission with incomplete recovery (CRi) is defined as the following:
Meets criteria for CR except
ANC < 1.0 x 109/L or platelet count < 100x109/L
Partial remission (PR).
• Must meet all criteria of a CR except that the bone marrow may contain 5-20% blasts."|8 weeks after infusion then 6 months after and every 4 months for approximately 2 years|||participants|||Number
671373|NCT01685567|Secondary|Ipsilateral Stroke (Non-hierarchical)|Data on ipsilateral stroke 31-365 days post procedure will be collected to provide additional supportive evidence of the safety of the device.|31-365 days|||Participants|||Count of Participants
671374|NCT01685567|Secondary|All Stroke (Non-hierarchical)|The analyses to be conducted on the secondary endpoints are intended to provide additional supportive evidence of the efficacy and safety of the device.|0 to 30 days|||Participants|||Count of Participants
671375|NCT01685567|Secondary|All Myocardial Infarctions (Non-hierarchical)|The analyses to be conducted on the secondary endpoints are intended to provide additional supportive evidence of the efficacy and safety of the device.|0 to 30 days|||Participants|||Count of Participants
671376|NCT01685567|Secondary|All Death (Non-hierarchical)|The analyses to be conducted on the secondary endpoints are intended to provide additional supportive evidence of the efficacy and safety of the device.|0 to 30 days|||Participants|||Count of Participants
671377|NCT01685567|Primary|Hierarchical Composite of Stroke, Myocardial Infarction, and Death|The primary endpoint was a hierarchical composite of any stroke, myocardial infarction and death during a 30-day post-procedural period in the ITT (pivotal and extended enrollment) population comprised of subjects deemed to be high risk for complications from CEA.|30-day post-procedure|||Participants|||Count of Participants
671378|NCT01685437|Secondary|Change From Baseline in Penile Length|A negative value represents a reduction in measurement from baseline.|Baseline and Week 36|Efficacy is based on the mITT population.||centimeters||Standard Deviation|Mean
671379|NCT01685437|Secondary|A Composite Responder Analysis Based on Change From Baseline in Penile Curvature and in the Peyronie's Disease Bother Score|"A composite responder is indicated by
a percent reduction from baseline in penile curvature greater than or equal to the threshold, and
a reduction from baseline in Peyronie's disease bother score greater than or equal to the threshold, or change in the overall sexual activity within the last 3 months to having vaginal intercourse from no vaginal intercourse at screening."|Week 36|Composite responder analysis is based on the intent-to-treat (ITT) population.||participants|||Number
671380|NCT01685437|Secondary|Change From Baseline in Penile Plaque Consistency|Penile plaque consistency score range 1 (non-palpable) to 5 (hard). A decrease in the change from baseline in penile plaque consistency is indicated by a negative number.|Baseline and Week 36|Efficacy is based on the mITT population.||units on a scale||Standard Deviation|Mean
671381|NCT01685437|Secondary|Change in the Overall Satisfaction Domain of the International Index of Erectile Function (IIEF)|Overall satisfaction domain of the IIEF score range 0 to 5 on 2 questions where higher scores indicate improved function or satisfaction; total score range 0 to 10.|Baseline and Week 36|Efficacy is based on the mITT population.||units on a scale||Standard Deviation|Mean
671382|NCT01685437|Secondary|A Responder Analysis Based on Subject Overall Global Assessment|Subject overall global assessment of Peyronie's disease score range -3 (much worse) to 3 (much improved). A score of 1 (improved in a small but important way), 2 (moderately improved), or 3 indicate a responder.|Week 36|Efficacy is based on the mITT population.||participants|||Number
671383|NCT01685437|Secondary|Change From Baseline in the Penile Pain Domain of the PDQ in Subjects With Baseline Penile Pain Score ≥4|Penile pain scale range 0 (no pain) to 10 (extreme pain) on 3 questions; total score range 0 to 30. A decrease in the change from baseline total score in the penile pain domain of the PDQ is indicated by a negative number. Subjects were required to have a penile pain score of 4 or greater at baseline.|Baseline and Week 36|Efficacy is based on the mITT population; this population only includes those subjects in the mITT population with a baseline penile pain score of 4 or greater.||units on a scale||Standard Deviation|Mean
671384|NCT01685437|Secondary|Change From Baseline in the Severity of Peyronie's Disease Symptoms Domain of the PDQ|Peyronie's disease symptoms (physical and psychological) severity score range 0 (none) to 4 (very severe) on 6 questions; total score range 0 to 24. A decrease in the change from baseline total score in the Peyronie's disease symptoms domain of the PDQ is indicated by a negative number.|Baseline and Week 36|Efficacy is based on the mITT population.||units on a scale||Standard Deviation|Mean
671385|NCT01685437|Primary|Change From Baseline in the Peyronie's Disease Bother Domain of the Peyronie's Disease Questionnaire (PDQ)|Peyronie's disease bother score range 0 (no issue or not at all bothered) to 4 (extremely bothered) on 4 questions; total score range 0 to 16. A decrease in the change from baseline total score in the Peyronie's disease bother domain of the PDQ is indicated by a negative number.|Baseline and Week 36|Efficacy is based on the mITT population.||units on a scale||Standard Deviation|Mean
671386|NCT01685437|Primary|Percentage Change From Baseline in Penile Curvature|A negative value in the percentage change from baseline in penile curvature deformity (angle measured in degrees) indicates less curvature.|Baseline and Week 36|Efficacy is based on modified intent-to-treat (mITT) population.||percentage of curvature change||Standard Deviation|Mean
671387|NCT01685320|Secondary|Time Required to Visualize the Glottis and Complete Oro-tracheal Intubation|Since the time needed for laryngoscopy and intubation could represent one of the major contributors to the stress response during these procedures, times to achieve the glottis visualization and to perform the entire intubation were recorded.|On average 20 seconds|We have utilized our previous in vitro study on manikin (Carassiti et al. Br J Anaesth 2012; 108: 146-151) as basis for the calculus of sample size in this research, considering 95% confidence interval (2-sided), power of 80%, ratio of sample size (Group B/Group A) = 1.||seconds||Standard Deviation|Mean
671388|NCT01685320|Primary|Force Applied and Pressure Distribution Upon the Blade of Laryngoscopes During Tracheal Intubation.|The pressure distribution exerted upon the tissues by the blade was measured (in Newton)through pressure film transducers put on the blade of both direct and indirect laryngoscopes, in order to compare the two devices.|Force measurement is referred to an average of 45 seconds in patients scheduled to undergo elective surgery under general anaesthesia|We have utilized our previous in vitro study on manikin (Carassiti et al. Br J Anaesth 2012; 108: 146-151) as basis for the calculus of sample size in this research, considering 95% confidence interval (2-sided), power of 80%, ratio of sample size (Group B/Group A) = 1.||Newton||Standard Deviation|Mean
675691|NCT01636778|Secondary|Median Platelet Count at the Indicated Time Points in Part 1|Platelet counts were measured by blood draw|Baseline, Week1, 2, 3, 4, 5, 6, 7, 8, 9, Withdrawal in Part 1|FAS1 Population.||10^9 Cells Per Liter (Gi/L)||Full Range|Median
671414|NCT01685216|Secondary|Number of Participants Who Developed Anti-Velaglucerase Alfa Antibodies During The Study|Participants provided blood samples for measurement of anti-velaglucerase alfa antibodies in serum at baseline and approximately every 12 weeks during the treatment phase. Blood samples collected during the treatment phase were to be drawn prior to infusions. Analysis of anti-velaglucerase antibodies used a validated 3-tier immunoassay method (screening, confirmatory, and titer).|Baseline, Weeks 13, 25, 37 and 53|The Intent-to-Treat population, defined as all participants who received at least 1 study drug infusion (full or partial).||participants|||Number
671415|NCT01685216|Secondary|Number of Participants Who Experienced a Treatment-Emergent Adverse Event|Adverse events (AEs) were monitored continuously throughout the study from the time the participant or participants parent/legal guardian signed the informed consent/assent (if applicable) until 30 days after the participant’s last dose of study drug or at the end of study visit and/or until the event resolved or stabilized, or an outcome had been reached, whichever came first. Treatment-emergent adverse events (TEAEs) were defined as AEs which occurred on or after the time of the first infusion until 30 days after the participant’s last study infusion. An infusion-related reaction is defined as an AE that 1) began either during or within 12 hours after the start of the infusion, and 2) was judged as possibly or probably related to study medication.|57 weeks|The Safety Analysis population, defined as all participants who received at least 1 study drug infusion (full or partial).||participants|||Number
675743|NCT01636076|Secondary|Mixed Model for Repeated Measures (MMRM): Between-treatment Comparisons for FEV1 (L), by Visit and Timepoint||Day 1 through day 85|Full analysis set consisting of all randomized patients||liter||Standard Error|Least Squares Mean
671416|NCT01685216|Secondary|Number of Participants With Abnormal Neurological Status During The Study|Neurological symptoms were evaluated at regular intervals during the study and assessed on an individualized basis by a limited, age- and developmental stage-appropriate neurological examination adapted to suit the status of each participant. It was preferred that each neurological examination be performed by a neurologist with experience in assessment of neurological symptoms in patients with Gaucher disease and, if possible, the same neurologist (or designee) who evaluated a given participant at baseline performed the neurological examinations scheduled for that participant during the treatment phase and at the end of study visit.|Baseline, Weeks 13, 25, 37, and 53 or end of study|The Intent-to-Treat population, defined as all participants who received at least 1 study drug infusion (full or partial).||participants|||Number
671417|NCT01685216|Secondary|Percent Change From Baseline to 12 Months (Week 51) in Normalized Spleen Volume Measured Using Magnetic Resonance Imaging (MRI)|Quantitative abdominal MRI was used to measure spleen volume. If sedation was necessary to perform an MRI and the investigator deemed that this would be an unwarranted risk to the participant, spleen volume could have been measured by ultrasound. Organ volume was measured by a single independent reviewer who was blinded to the participant identification and time point. The spleen size relative to body weight was determined using the corresponding body weight measured at the same visit. Change in spleen volume is presented as the normalized percentage of body weight. A negative change from baseline indicates that spleen volume decreased.|Baseline, Week 51|The Intent-to-Treat population, defined as all participants who received at least 1 study drug infusion (full or partial).||percent change||Standard Deviation|Mean
671418|NCT01685216|Secondary|Percent Change From Baseline to 12 Months (Week 51) in Normalized Liver Volume Measured Using Magnetic Resonance Imaging (MRI)|Quantitative abdominal MRI was used to measure liver volume. If sedation was necessary to perform an MRI and the investigator deemed that this would be an unwarranted risk to the participant, liver volume could have been measured by ultrasound. Organ volume was measured by a single independent reviewer who was blinded to the participant identification and time point. The liver size relative to body weight was determined using the corresponding body weight measured at the same visit. Change in liver volume is presented as the normalized percentage of body weight. A negative change from baseline indicates that liver volume decreased.|Baseline, Week 51 or end of study|The Intent-to-Treat population, defined as all participants who received at least 1 study drug infusion (full or partial).||percent change||Standard Deviation|Mean
671419|NCT01685216|Secondary|Change From Baseline to 12 Months (Week 53) in Platelet Count|Platelet count was measured at a central laboratory as part of the hematology panel. Baseline is the modified baseline platelet count, the average of the values from screening, baseline and Week 1/Day 1. A positive change from baseline indicates that platelet count increased.|Baseline, Week 53|The Intent-to-Treat population, defined as all participants who received at least 1 study drug infusion (full or partial).||platelets (x10^9)/L||Standard Deviation|Mean
671420|NCT01685216|Primary|Change From Baseline to 12 Months (Week 53) in Hemoglobin Concentration|Hemoglobin concentration was measured as part of the hematology panel or measured separately when the hematology panel was not scheduled. Samples were measured by a central laboratory. Baseline is the modified baseline hemoglobin concentration, the average of the values from screening, baseline, and Week 1/Day 1. A positive change from baseline indicates that hemoglobin concentration increased.|Baseline, Week 53 or end of study|The Intent-to-Treat population, defined as all participants who received at least 1 study drug infusion (full or partial).||g/dL||Standard Deviation|Mean
671421|NCT01685203|Secondary|Percentage of Participants in Each Treatment Group With Treatment-emergent Adverse Events|Treatment-emergent adverse events were defined as any event that began or worsened in severity after initiation of study drug through 30 days after the last dose of study drug.|From the start of study drug administration until 30 days after the last dose,16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8.|All randomized participants who received at least 1 dose of study drug.||Percentage of participants|||Number
671422|NCT01685203|Secondary|Percentage of Participants in Each Treatment Group With Post-treatment Virologic Relapse.|Participants were considered to have virologic relapse after treatment if they had confirmed quantifiable plasma Hepatitis C virus ribonucleic acid (HCV RNA) ≥ lower limit of quantification (LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA < LLOQ at the end of treatment.|Within 12 weeks after the last dose of study drug|All randomized participants who received at least 1 dose of study drug and completed treatment with HCV RNA < LLOQ at the final treatment visit.||Percentage of participants||95% Confidence Interval|Number
671423|NCT01685203|Secondary|Percentage of Participants in Each Treatment Group With On-treatment Virologic Failure.|Virologic failure during treatment was defined as rebound (confirmed HCV RNA greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA < LLOQ during treatment, or confirmed increase from the lowest value post baseline in HCV RNA [2 consecutive HCV RNA measurements > 1 log(subscript)10(subscript) IU/mL above the lowest value post baseline] at any time point during treatment), or fail to suppress (HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks [≥ 36 days] of treatment).|Baseline (Day 1), Day 3, and Treatment Weeks 1, 2 ,3 ,4, 6, 8, 10, and 12 for all participants and Treatment Weeks 16, 20 and 24 for Groups 7 and 8|All randomized participants who received at least 1 dose of study drug.||Percentage of participants||95% Confidence Interval|Number
671424|NCT01685203|Primary|Percentage of Participants in Each Treatment Group With Sustained Virologic Response 12 Weeks Post-treatment|The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [<LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of study drug|All randomized participants who received at least 1 dose of study drug.||Percentage of participants||95% Confidence Interval|Number
671425|NCT01685203|Secondary|Percentage of Participants in Each Treatment Group With Sustained Virologic Response 24 Weeks Post-treatment|The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [<LLOQ]) 24 weeks after the last dose of study drug.|24 weeks after the last actual dose of study drug|All randomized participants who received at least 1 dose of study drug.||Percentage of participants||95% Confidence Interval|Number
671566|NCT01683604|Secondary|Percentage of Participants With Reasons Who Discontinued Tocilizumab||Baseline up to Month 6|FAS population. Here, Number of Participants Analyzed (N) signifies participants who discontinued tocilizumab treatment.||percentage of participants|||Number
671426|NCT01685060|Secondary|Overall Survival (OS)|OS, defined as the time from date of randomization/start of treatment to date of death due to any cause. If a patient was not known to have died, survival was censored at the date of last known date patient alive.|6 cycles of 28 days up to 24 weeks|Full Analysis Set (FAS) consisted of all patients who received at least one dose of ceritinib.||Months||95% Confidence Interval|Median
671427|NCT01685060|Secondary|Overall Intracranial Response Rate (OIRR) Per BIRC|OIRR calculated as the ORR (CR+PR) of lesions in the brain for patients who had measureable disease in the brain at baseline.|6 cycles of 28 days up to 24 weeks|The Full Analysis Set (FAS) consists of all patients who received at least one dose of ceritinib. Only patients with measurable disease in brain at baseline selected by BIRC were included in this analysis.||Percentage of participants||95% Confidence Interval|Number
671428|NCT01685060|Secondary|Overall Intracranial Response Rate (OIRR) Per Investigator|OIRR calculated as the ORR (CR+PR) of lesions in the brain for patients who had measureable disease in the brain at baseline.|6 cycles of 28 days up to 24 weeks|The Full Analysis Set (FAS) consists of all patients who received at least one dose of ceritinib. Only patients with measurable disease in brain at baseline selected by Investigator were included in this analysis.||Percentage of participants||95% Confidence Interval|Number
671429|NCT01685060|Secondary|Progression-free Survival (PFS) Per BIRC|PFS, defined as the time from date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient had no event or when the patient received any further anticancer therapy in the absence of disease progression, progression-free survival was censored at the date of last adequate tumor assessment.|6 cycles of 28 days up to 24 weeks|The Full Analysis Set (FAS) consists of all patients who received at least one dose of ceritinib.||months||95% Confidence Interval|Median
671430|NCT01685060|Secondary|Progression-free Survival (PFS) Per Investigator|PFS, defined as the time from date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient had no event or when the patient received any further anticancer therapy in the absence of disease progression, progression-free survival was censored at the date of last adequate tumor assessment.|6 cycles of 28 days up to 24 weeks|The Full Analysis Set (FAS) consists of all patients who received at least one dose of ceritinib.||months||95% Confidence Interval|Median
671431|NCT01685060|Secondary|Time to Response (TTR) Per BIRC|TTR is the time from date of start of treatment to the first CR or PR observed which are confirmed afterwards.|6 cycles of 28 days up to 24 weeks|The Full Analysis Set (FAS) consists of all patients who received at least one dose of ceritinib. Only patients with confirmed complete response/partial response (CR/PR) were included in this analysis.||Months||Standard Deviation|Mean
671432|NCT01685060|Secondary|Time to Response (TTR) Per Investigator|TTR is the time from date of start of treatment to the first CR or PR observed which were confirmed afterwards.|6 cycles of 28 days up to 24 weeks|The Full Analysis Set (FAS) consists of all patients who received at least one dose of ceritinib. Only patients with confirmed complete response/partial response (CR/PR) were included in this analysis.||Months||Standard Deviation|Mean
671433|NCT01685060|Secondary|Disease Control Rate (DCR)|DCR was calculated as the percentage of patients with best overall response of CR, PR, SD, or non-CR non-PD (NCRNPD), per RECIST 1.1 by investigator. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm 1. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD. Non-CR/Non-PD (NCRNPD): refers to best overall responses that are neither CR nor PD per RECIST 1.1 criteria for patients with non-measurable disease only at baseline.|6 cycles of 28 days up to 24 weeks|Full Analysis Set (FAS) consisted of all patients who received at least one dose of ceritinib.||Percentage of participants||95% Confidence Interval|Number
671434|NCT01685060|Secondary|Duration of Response (DOR) by BIRC|DOR, calculated as the time from the date of the first documented CR or PR to the first documented progression or death due to underlying cancer, by BIRC (Blinded Imaging Review Committee). CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm 1. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.|6 cycles of 28 days up to 24 weeks|Full Analysis Set (FAS) consisted of all patients who received at least one dose of ceritinib. Only patients with confirmed complete response/partial response (CR/PR) per BIRC were included in this analysis.||Months||95% Confidence Interval|Median
671435|NCT01685060|Secondary|Duration of Response (DOR) by Investigator|DOR, calculated as the time from the date of the first confirmed CR or PR to the first documented progression or death due to any cause, by investigator. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm 1. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.|6 cycles of 28 days up to 24 weeks|Full Analysis Set (FAS) consisted of all patients who received at least one dose of ceritinib. Only patients with confirmed complete response/partial response (CR/PR) per Investigator were included in this analysis.||Months||95% Confidence Interval|Median
671436|NCT01685060|Secondary|ORR Per Blinded Independent Review Committee (BIRC) Assessment|ORR (CR+PR) by BIRC is calculated as the percentage of patients with a best overall confirmed response defined as complete response or partial response (CR+PR) as assessed by BIRC. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm 1. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.|6 cycles of 28 days up to 24 weeks|The Full Analysis Set (FAS) consists of all patients who received at least one dose of ceritinib.||Percentage of participants||95% Confidence Interval|Number
671437|NCT01685060|Primary|Overall Response Rate (ORR) to LDK378 Per Investigator Assessment|ORR per RECIST 1.1 calculated as the percentage of patients with a best overall confirmed response defined as complete response or partial response (CR+PR) as assessed by investigator. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm 1. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.|6 cycles of 28 days up to 24 weeks|Full Analysis Set (FAS) consisted of all patients who received at least one dose of ceritinib.||Percentage of participants||95% Confidence Interval|Number
671438|NCT01684930|Secondary|Change in Angiogenesis|Gastrocnemious muscle biopsy will be performed to measure the number of capillaries per fibre as a marker of change in angiogenesis between groups|Baseline and 16 weeks|Participants who had a gastrocnemius muscle biopsy with enough tissue to analyze.||capillaries per fibrer||Standard Deviation|Mean
671439|NCT01684930|Secondary|Change In Vascular Function (BAFMD)|Vascular Function is measured as Brachial artery flow-mediated dilation (BAFMD). BAFMD is a measure of change in artery diameter after a stimulus .|Baseline and 16 weeks|participants with analyzable data||% dilation||Standard Deviation|Mean
671440|NCT01684930|Secondary|Change In Claudication Onset Time|Exercise capacity will be assessed using a maximal cardiopulmonary exercise (CPX) test with expired gas analysis, for determination of claudication onset time.|Baseline and 16 weeks|||seconds||Standard Deviation|Mean
671441|NCT01684930|Secondary|Change in Functional Ability|Six-Minute Walk test. This test simple and practical assessment of functional capacity. The test measures the distance that a patient can walk on a flat, hard surface in a period of 6 minutes. The test is self-paced and assesses the submaximal level of functional capacity. The subjects choose their own intensity and are allowed to stop and rest if necessary during the test.|Baseline and 16 Weeks|||feet||Standard Deviation|Mean
671442|NCT01684930|Primary|Change In Time To Exhaustion|Exercise capacity will be assessed using a maximal cardiopulmonary exercise (CPX) test with expired gas analysis, for determination of total time to exhaustion.|Baseline and 16 weeks|||seconds||Standard Deviation|Mean
671443|NCT01684930|Primary|Change in Exercise Capacity: VO2peak (Maximal Oxygen Consumption)|Exercise capacity will be assessed using a maximal cardiopulmonary exercise (CPX) test with expired gas analysis, for determination of peak oxygen consumption, claudication onset time and peak walking time.|Baseline and 16 Weeks|All participants who completed study.||ml/kg/min||Standard Deviation|Mean
671444|NCT01684878|Secondary|Part 2: Overall Survival|Overall survival was defined as the time from randomization into Part 2 of the trial until death from any cause|Approximately 44 months (assessed at screening and every 9 weeks from randomization until disease progression)|ITT Population included all randomized participants in the group to which they were randomly assigned (‘as randomized’ analysis)||months||95% Confidence Interval|Median
671445|NCT01684878|Secondary|Part 2: Percentage of Participants With Adverse Events (AEs)|An AE can be any unfavorable and unintended sign (including an abnormality laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Approximately 28 months (assessed at screening, baseline until 28 days after the last dose of study treatment)|Safety population included all participants who had received at least 1 dose of pertuzumab, pertuzumab-placebo, or chemotherapy.||percentage of participants|||Number
671446|NCT01684878|Secondary|Part 2: European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QoL) Questionnaire (QLQ) of Core 30 (C30) Score|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale [1 'very poor' to 7 'Excellent']). Scores averaged, transformed to 0-100 scale; for functional scores, a higher score represents a better level of functioning. For symptom scores, a higher score represents a more severe level of symptoms. For the global health status scores, a higher score represents a better quality of life.|Baseline (assessed at baseline and every 9 weeks from randomization until disease progression)|ITT population included all randomized participants in the group to which they were randomly assigned (‘as randomized’ analysis).||units on a scale||Standard Deviation|Mean
671447|NCT01684878|Secondary|Part 2: Progression-free Survival (PFS) Assessed by the Investigator|PFS (Investigator-assessed) is defined as the time from randomization, until disease progression according to RECIST v1.1 including death or MBO, whichever occurs first. Censoring is based on the last tumor assessment. If no tumor assessment post baseline, then censoring is at day 1. PD could base on symptom deterioration or was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions.|Approximately 44 months (assessed at screening and every 9 weeks from randomization until disease progression)|ITT Population included all randomized participants in the group to which they were randomly assigned (‘as randomized’ analysis)||months||95% Confidence Interval|Median
671448|NCT01684878|Secondary|Part 1: PFS Assessed by the Investigator|PFS as assessed by Investigator was defined as the time from first dose of pertuzumab or chemotherapy in Part 1 of the trial, until disease progression according to RECIST version 1.1, symptomatic deterioration or death from any cause, whichever occurs first. PD could base on symptom deterioration or was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions. Participants were censored at the last tumor assessment. Participants who have no tumor assessments after baseline and who were still alive will be censored at 1 day.|Approximately 28 months (assessed at screening and every 9 weeks from randomization until disease progression)|All Treated population included all participants enrolled and treated in Part 1 of the study (‘as treated’ analysis) and who had received at least 1 dose of pertuzumab or chemotherapy.||months||95% Confidence Interval|Median
671449|NCT01684878|Secondary|Part 2- Objective Response Rate (ORR)|ORR was defined as the number of participants with BOR of CR or PR recorded from the start of treatment, until the end of treatment. BOR documented as confirmed CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 millimeter (mm). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|Approximately 44 months (assessed at screening and every 9 weeks from randomization until disease progression)|ITT population with measurable disease at baseline.||percentage of participants||95% Confidence Interval|Number
671567|NCT01683604|Secondary|Mean Dosing Interval at Month 6|The time interval between two successive doses in days was reported.|Month 6|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure.||days||Standard Deviation|Mean
671450|NCT01684878|Secondary|Part 1- Objective Response Rate (ORR)|ORR was defined as the number of participants with best overall response (BOR) of complete response (CR) or partial response (PR) recorded from the start of treatment, until the end of treatment. BOR documented as confirmed CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 millimeter (mm). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|Approximately 28 months (assessed at baseline and every 9 weeks from randomization until disease progression)|All Treated participants with measurable disease at baseline.||percentage of participants|||Number
671451|NCT01684878|Primary|Part 2: Progression Free Survival (PFS) as Assessed by a Blinded Independent Review Committee (IRC) Including Malignant Bowel Obstruction (MBO)|PFS (IRC-Assessed) was defined as the time from randomization into Part 2 of the trial until progressive disease (PD), MBO or death from any cause, whichever occurred first per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. PD could base on symptom deterioration or was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions.|Approximately 44 months (assessed at screening and every 9 weeks from randomization until disease progression)|ITT Population was defined as all randomized participants in the group to which they were randomly assigned (‘as randomized’ analysis).||months||95% Confidence Interval|Median
671452|NCT01684878|Primary|Part 1: Percentage of Participants With Adverse Events (AEs)|An AE can be any unfavorable and unintended sign (including an abnormality laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Approximately 28 months (assessed at screening, baseline until 28 days after the last dose of study treatment)|All Treated population included all participants enrolled and treated in Part 1 of the study (‘as treated’ analysis) and who had received at least 1 dose of pertuzumab or chemotherapy.||percentage of participants|||Number
671453|NCT01684839|Other Pre-specified|Tinel’s Sign|Tinel’s sign was graded as the following: grade 1=none; grade 2=mild, slight tingle; grade 3=moderate, very uncomfortable; and grade 4=severe, patient unable to use hand because of any stimulation of the neuroma|20-26 months postoperatively||||||
671454|NCT01684839|Secondary|Cold Intolerance Severity Score (CISS) Questionnaire|The maximum score was 100 and was grouped into 4 ranges (0–25; 26–50; 51–75; and 76–100), corresponding to mild, moderate, severe, and extreme severity, respectively.|20-26 months postoperatively||||||
671455|NCT01684839|Primary|Static 2-point Discrimination Test|The Static 2-point Discrimination Test determined the minimal distance at which a subject can sense the presence of two needles. The modified American Society for Surgery of the Hand guidelines was used to stratify the 2PD measurements (excellent <6 mm; good 6–10 mm; fair 11–15 mm; poor >15 mm). The test points were at the center of the radial or ulnar portion of the finger pulp (i.e., injury side). Each area was tested 3 times with a discriminator (Ali Med, Dedham, MA). Two out of 3 correct answers were considered proof of perception before proceeding to another lower value. We stopped at 4mm as a limit of 2PD and consider this normal. The measurements were performed at a single time point at the final follow up.|20-26 months postoperatively|||mm||Standard Deviation|Mean
671456|NCT01684826|Other Pre-specified|Radiation Dose Measurements: Air Kerma (AK)|Percentage of change of ClarityIQ vs. AlluraXper in Air Kerma (AK) calculated by AK/frame. Negative percentage means a reduction in dose for ClarityIQ vs. AlluraXper.|Participants were followed for the duration of the procedure|all patients with recorded dose information and images for both angiograms were included (n=39)||percentage of dose change||Standard Deviation|Mean
671457|NCT01684826|Secondary|Radiation Dose Measurements: Dose Area Product (DAP)|Percentage of change of ClarityIQ vs. AlluraXper in Dose Area Product (DAP) calculated by DAP/frame. Negative percentage means a reduction in dose for ClarityIQ vs. AlluraXper.|Participants were followed for the duration of the procedure|all patients with recorded dose information and images for both angiograms were included (n=39)||percentage of dose change||Standard Deviation|Mean
671458|NCT01684826|Primary|Image Quality|"Overall proportion where diagnostic image quality of ClarityIQ is scored equal or better compared to AlluraXper by the blinded readers. Reading is performed by simultaneous visual comparison of the image quality of AlluraXper and ClarityIQ by multiple blinded reviewers.The images are presented in a randomized order.
The hypothesis is that the overall proportion where diagnostic image quality of ClarityIQ is scored equal or better is ≥ than 0.80. Combined for all raters, the lower bound of the one-sided 95% CI (lower bound of the two-sided 90% CI)is used."|1 day|All patient with recorded dose information and images for both angiograms were used.||proportion of readers||90% Confidence Interval|Mean
671459|NCT01684748|Other Pre-specified|Proinflammatory and Collagen Gene Expression in Skeletal Muscle||8 weeks||||||
671460|NCT01684748|Primary|Insulin Sensitivity by Intravenous Glucose Tolerance Testing (Change Over Time)|Data collected from the intravenous glucose tolerance tests included blood concentrations of glucose and insulin. Glucose was measured immediately on a YSI glucose analyzer and insulin was measured via ELISA colormetric kits once all study samples were collected. To analyze changes in insulin sensitivity, the MINMOD software was used. The MINMOD software uses Bergman's minimal model to determine insulin sensitivity during an intravenous glucose tolerance test. Both glucose and insulin values were inserted at each timepoint collected (33 in total over the 3-hour protocol) and the software was run to generate the insulin sensitivity value at baseline and post-test. This information was then used to calculate the change of insulin sensitivity from baseline to post-testing after each 8-week intervention.|Baseline testing to post-testing after 8-week intervention|Results of insulin sensitivity by intravenous glucose tolerance (IVGTT) testing are reported per intervention (Olmesartan Medoxomil and No drug). Only 10 of the 16 study participants who participated in all or some of the study measurements opted to complete or had sufficient data to analyze for each pre- and post-intervention (4 total) IVGTT.||mu/L/min||Standard Deviation|Mean
671461|NCT01684748|Primary|CD68 Gene Expression by Immunohistochemistry of Adipose Tissue||8 weeks||||||
671568|NCT01683604|Secondary|Percentage of Participants With Tocilizumab Dose Changed According to the Reason for Change|Percentage of participants with increase or decrease in tocilizumab administration according to the reason for dose modification was reported.|Baseline up to Month 6|FAS population.||percentage of participants|||Number
671462|NCT01684566|Secondary|Duration of Oral Mucositis, Per Protocol Population|Duration of oral mucositis during the treatment period of 28 Days. Oral mucositis is graded according to the 5-point oral mucositis WHO scale Grade 0 No mucositis Grade 1 Soreness ± erythema, no ulceration Grade 2 Erythema, ulcers. Patients can swallow solid diet Grade 3 Ulcers, extensive erythema. Patients cannot swallow solid diet Grade 4 Oral mucositis to the extent that alimentation is not possible|28 days|Per Protocol (PP). There were 9 patients in the episil +SOC group and 12 patients in the SOC group who had no data for duration of oral mucositis||Days||Standard Deviation|Mean
671463|NCT01684566|Secondary|Occurence of Oral Mucositis, Per Protocol Population|"Occurrence of oral mucositis (ie, oral mucositis defined as WHO (World Health Organisation) oral toxicity scale grade 0-4
A higher score represents a more severe oral mucositis Grade 0 No mucositis Grade 1 Soreness ± erythema, no ulceration Grade 2 Erythema, ulcers. Patients can swallow solid diet Grade 3 Ulcers, extensive erythema. Patients cannot swallow solid diet Grade 4 Oral mucositis to the extent that alimentation is not possible"|28 days|Per Protocol (PP)||participants|||Number
671464|NCT01684566|Primary|WHO (World Health Organisation) Oral Mucositis Severity Score During 28 Days of Treatment, Per Protocol Population|"Summary of WHO (World Health Organisation) Oral Toxicity Scores AUC Over the 28-Day Period Per protocol population.
A higher score represents a more severe oral mucositis Grade 0 No mucositis Grade 1 Soreness ± erythema, no ulceration Grade 2 Erythema, ulcers. Patients can swallow solid diet Grade 3 Ulcers, extensive erythema. Patients cannot swallow solid diet Grade 4 Oral mucositis to the extent that alimentation is not possible"|28 days|Per Protocol (PP) without Last observation carried over(LOCF)||score||Standard Deviation|Mean
671465|NCT01684566|Secondary|Hospital Stay, Days|Duration of hospital stay (time from admission to discharge)|28 days|Intention to treat (ITT) Hospital stay, days||Days||Standard Deviation|Mean
671466|NCT01684566|Secondary|Oral Mucositis Assessment Scale (OMAS)|"Summary of Oral Mucositis Assessment Scale (OMAS) Ulceration and Erythema Scores Extent of ulceration (grade 0-3) and severity of erythema (grade 0-2) according to the OMAS (Oral Mucositis Assessment Scale) assessed by a dental practitioner twice-weekly over the 28-day study period.
The extent of ulceration was rated as follows:
0 no lesion
1 cm2
1-3 cm2
>3 cm2
The severity of erythema was assessed as follows:
0 none
not severe
severe"|28 days|Intention to treat (ITT) Ulceration and Erythema.OMAS was only performed in sites were a dentist was available therefore lower numbers in the analysis.||score||Standard Deviation|Mean
671467|NCT01684566|Secondary|Oral Mucositis Daily Questionnaire (OMDQ)|OMDQ (Oral Mucositis Daily Questionnaire) scale was used to measure Overall Mouth and Throat Soreness This was scored from 0=no soreness to 10=worst possible soreness.|28 days|Intention to treat(ITT) OMDQ AUC over time. Not all patients reported data from OMDQ therefore there is lower number of patients in this analysis.||units on a scale||Standard Deviation|Mean
671468|NCT01684566|Secondary|Duration of Oral Mucositis, Intention to Treat Population|"Duration of oral mucositis during the treatment period of 28 Days. Oral mucositis was graded according to WHO 5 Point grading scale on a daily basis.
Grade 0 No mucositis Grade 1 Soreness ± erythema, no ulceration Grade 2 Erythema, ulcers. Patients can swallow solid diet Grade 3 Ulcers, extensive erythema. Patients cannot swallow solid diet Grade 4 Oral mucositis to the extent that alimentation is not possible"|28 days|ITT (Intention to treat). There were13 patients in the episil +SOC group and 12 patients in the SOC group who had no data for duration of oral mucositis||Days||Standard Deviation|Mean
671469|NCT01684566|Secondary|Occurrence of Oral Mucositis|"Occurrence of oral mucositis (ie, oral mucositis defined as WHO (World Health Organization) oral toxicity scale grade 0-4.
A higher score represents a more severe oral mucositis Grade 0 No mucositis Grade 1 Soreness ± erythema, no ulceration Grade 2 Erythema, ulcers. Patients can swallow solid diet Grade 3 Ulcers, extensive erythema. Patients cannot swallow solid diet Grade 4 Oral mucositis to the extent that alimentation is not possible"|28 days|Intention to treat (ITT)||participants|||Number
671470|NCT01684566|Primary|WHO (World Health Organisation) Oral Mucositis Severity Score During 28 Days of Treatment, Intention to Treat Population|"Summary of WHO (World Health Organisation) Oral Toxicity Scores Area under the curve (AUC) over the 28-Day Period ITT Populations.
A higher score represents a more severe oral mucositis Grade 0 No mucositis Grade 1 Soreness ± erythema, no ulceration Grade 2 Erythema, ulcers. Patients can swallow solid diet Grade 3 Ulcers, extensive erythema. Patients cannot swallow solid diet Grade 4 Oral mucositis to the extent that alimentation is not possible"|28 days|Intention to treat (ITT) and Last observation carried forward (LOCF)||score||Standard Deviation|Mean
671471|NCT01684436|Primary|Concentration of Tear Cytokine Levels Following Punctal Plug Insertion in the Study Eye|A punctal plug (tear duct plug) is a device inserted into the tear duct (puncta) of the eye to block the tear duct from draining liquid from the eye. Tears were collected using the Schirmer's test strip. Tears are measured in the study eye for tear cytokine levels before punctal plug insertion in picogram(pg)/milliliter (mL)/millimeter (mm) of Schirmer's test strip moistened. Cytokines help with the generation of an immune response. Increased cytokine levels are representative of inflammation in the eye.|Week 3|All patients who completed the study||picogram/milliliter/millimeter(pg/ml/mm)||Standard Deviation|Mean
671472|NCT01684436|Secondary|Dry Eye Questionnaire Irritation Score|Severity of dry eye irritation is rated by the patient using a visual analogue scale (VAS). Patients put a mark on a 100 millimeter line where 0 (far left on the line)=no symptoms to 100 (far right on the line)=most severe symptoms. The higher the score, the more severe the symptoms.|Week 0 (Baseline), Week 3|All patients who completed the study||Millimeters (mm)||Standard Deviation|Mean
671473|NCT01684436|Secondary|Schirmer's Test Score|The Schirmer's Test measures the rate of tear secretion by the eye over 5 minutes (min). The results indicate the presence of dry eye (Normal = greater than or equal to 10 millimeters (mm) of tears, Dry Eye = less than 10 mm of tears). The smaller the number, the more severe the dry eye.|Week 0 (Baseline), Week 3|All patients who completed the study||Millimeters (mm)||Standard Deviation|Mean
671474|NCT01684436|Secondary|Tear Film Break-up Time (TBUT)|TBUT is defined as the time to initial breakup of the tear film following a blink. The longer it takes, the more stable the tear film.|Week 0 (Baseline), Week 3|All patients who completed the study||Seconds||Standard Deviation|Mean
671569|NCT01683604|Secondary|Median Dose at Month 6||Month 6|FAS population. Here Number of participants analyzed = participants evaluable for the outcome measure.||milligram per kilogram (mg/kg)||Full Range|Median
671570|NCT01683604|Secondary|Percentage of Participants Starting Tocilizumab After Stopping a Biologic Treatment or After Failing DMARDs||Baseline|FAS population.||percentage of participants|||Number
671475|NCT01684436|Secondary|Corneal Fluorescein Staining Score in the Study Eye|The cornea is evaluated following ocular administration of fluorescein stain in the study eye. The cornea is the transparent front part of the eye which covers the iris and pupil. The cornea is divided into 5 regions. Each region is scored according to the extent of staining, with scores ranging from 0 to 4 points: 0=non-staining to 4=regional whole staining of the cornea with 0.5 unit intervals. The higher the staining score, the worse the dry eye condition.|Week 0 (Baseline), Week 3|All patients who completed the study||Scores on a Scale||Standard Deviation|Mean
671476|NCT01684436|Primary|Concentration of Tear Cytokine Levels Before Punctal Plug Insertion in the Study Eye|A punctal plug (tear duct plug) is a device inserted into the tear duct (puncta) of the eye to block the tear duct from draining liquid from the eye. Tears were collected using the Schirmer's test strip. Tears are measured in the study eye for tear cytokine levels before punctal plug insertion in picogram(pg)/milliliter (mL)/millimeter (mm) of Schirmer's test strip moistened. Cytokines help with the generation of an immune response. Increased cytokine levels are representative of inflammation in the eye.|Week 0 (Baseline)|All patients who completed the study||picogram/milliliter/millimeter(pg/ml/mm)||Standard Deviation|Mean
671477|NCT01684423|Secondary|Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Specified Time Points|Geometric and percentage geometric coefficient of variation (%CV) were reported.|0 hours (pre-dose) to 8 hours post-dose on Day 15 and 24 hours post-dose on Day 31|Pharmacokinetic analysis set (N= 42) included all subjects with at least one pharmacokinetic sample in accordance with the pharmacokinetic sampling strategy.||microgram per liter (mcg/L)||Geometric Coefficient of Variation|Geometric Mean
671478|NCT01684423|Secondary|Anti-factor Xa Values at Specified Time Points|The individual anti-Factor Xa activity was determined ex-vivo using a photometric method.|0 hours (pre-dose) to 8 hours post-dose on Day 15 and 24 hours post-dose on Day 31|Pharmacodynamic analysis set (N=42) included all subjects with at least one blood sample for clotting parameters in accordance with the pharmacodynamic sampling strategy.||microgram per liter (mcg/L)||Standard Deviation|Mean
671479|NCT01684423|Secondary|Change From Baseline in Activated Partial Thromboplastin Time at Specified Time Points|The Activated partial thromboplastin time (aPTT) is a screening test for the intrinsic pathway.|0 hours (pre-dose) to 8 hours post-dose on Day 15 and 24 hours post-dose on Day 31|Pharmacodynamic analysis set (N=42) included all subjects with at least one blood sample for clotting parameters in accordance with the pharmacodynamic sampling strategy.||seconds||Standard Deviation|Mean
671480|NCT01684423|Secondary|Change From Baseline in Prothrombin Time at Specified Time Points|Prothrombin time is a global clotting test used for the assessment of the extrinsic pathway of the blood coagulation cascade.|0 hours (pre-dose) to 8 hours post-dose on Day 15 and 24 hours post-dose on Day 31|Pharmacodynamic analysis set (N=42) included all subjects with at least one blood sample for clotting parameters in accordance with the pharmacodynamic sampling strategy.||seconds||Standard Deviation|Mean
671481|NCT01684423|Secondary|Number of Subjects With Asymptomatic Deterioration in Thrombotic Burden|The occurrence of asymptomatic deterioration in thrombotic burden was summarized by age group. Asymptomatic deterioration in thrombotic burden was documented by the appropriate imaging test and the results were classified as normalized, improved, no relevant change, deteriorated, not evaluable or not available.|Repeat imaging at the end of the 30 day treatment period|Full analysis set||Participants|||Number
671482|NCT01684423|Secondary|Number of Subjects With Symptomatic Recurrent Venous Thromboembolism|The occurrence of recurrent venous thromboembolism was summarized by age group. Symptomatic recurrence of venous thrombosis was documented by the appropriate imaging test.|From start of study drug administration until end of the 30-day treatment period|Full analysis set||Participants|||Number
671483|NCT01684423|Primary|Number of Subjects With Major and Clinically Relevant Non-Major Bleeding Events|"Central independent adjudication committee (CIAC) classified bleeding as follows: Major bleeding is defined as overt bleeding and:
associated with a fall in hemoglobin of 2 gram/decilitre (g/dL) or more, or
leading to a transfusion of the equivalent of 2 or more units of packed red blood cells or whole blood in adults, or
occurring in a critical site, e.g. intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal, or
contributing to death.
Clinically relevant non-major bleeding is defined as overt bleeding not meeting the criteria for major bleeding, but associated with:
medical intervention, or
unscheduled contact (visit or telephone call) with a physician, or
cessation (temporary) of study treatment, or
discomfort for the child such as pain or
impairment of activities of daily life (such as loss of school days or hospitalization)."|From start of study drug administration until end of the 30-day treatment period|Full analysis set. Data was evaluated only for subjects who received active study medication.||Participants|||Number
671484|NCT01684410|Other Pre-specified|Percent Change From Baseline in Forced Vital Capacity (FVC) at Week 3|FVC conducted before and after inhalation of the investigational product|3 weeks|Safety Population: included all subjects who received any dose of Investigational Product (included those withdrawn from treatment for any reason)||percent||Standard Deviation|Mean
671485|NCT01684410|Other Pre-specified|Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 3|FEV1 conducted before and after inhalation of the investigational product at study visits.|3 weeks|Safety Population: included all subjects who received any dose of Investigational Product (included those withdrawn from treatment for any reason)||percent||Standard Deviation|Mean
671486|NCT01684410|Primary|Adverse Events|adverse event frequency|3 weeks|Safety Population: included all subjects who received any dose of IP (included those withdrawn from treatment for any reason)||percentage of participants|||Number
672071|NCT01676896|Other Pre-specified|Lung Inflammation, Time 1|Exhaled breath condensation collected and sent for lab analysis of NO3. Data collected at Time 1 visit. Higher values represent greater airway inflammation.|Time 1 at baseline|||uM||Standard Deviation|Mean
671571|NCT01683604|Primary|C-Reactive Protein (CRP) at Baseline|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline|FAS population.||milligrams per liter (mg/L)||Standard Deviation|Mean
676489|NCT01624168|Primary|Adherence to Out-of-class Practice|Subjects are considered adherent to out-of-class practice if he/she practices outside of class twenty times during the 10 week intervention|10 weeks|||participants|||Number
676490|NCT01624168|Primary|Retention of Randomized Subjects for Follow-up|Subjects retained for follow-up are those willing to respond to follow-up assessments|2 months|||participants|||Number
671635|NCT01682876|Secondary|Number of Subjects Who Reported Selected AEs After Any Vaccination|Safety was assessed as the number subjects who reported Selected AEs from day 1 up to day 422 after one or two vaccination(s) of MenACWY-CRM|Day 1 to Day 422|Analysis was done on safety set||Subjects|||Number
671528|NCT01684046|Primary|Subjective Lens Wear Comfort|"Lens wear comfort was assessed by the participant on a 5-point Likert scale. The participant was instructed to select a single response to the statement, When I use this solution, I can comfortably wear my lenses, with 1 = strongly disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, and 5 = strongly agree."|Day 30|This analysis population includes all participants who were exposed to study regimen (test and control) and completed both study periods, excluding major protocol deviations.||units on a scale||Standard Deviation|Mean
671529|NCT01684033|Primary|Change From Baseline in Corneal Staining at Day 30|Corneal staining in both eyes was assessed during slit lamp examination using flourescein dye. Each of five corneal regions (central, nasal, temporal, inferior, and superior) was graded on a scale from 0 (none) to 4 (patch). The corneal fluorescein staining score was calculated as the total of the five regions. The score ranged from 0 (no staining in any region) to 20 (patch staining in all five regions). The corneal staining of the worse eye was analyzed.|Baseline (Day 0), Day 30|||units on a scale||Standard Deviation|Mean
671530|NCT01684033|Primary|Corneal Staining|Corneal staining in both eyes was assessed during slit lamp examination using flourescein dye. Each of five corneal regions (central, nasal, temporal, inferior, and superior) was graded on a scale from 0 (none) to 4 (patch). The corneal fluorescein staining score was calculated as the total of the five regions. The score ranged from 0 (no staining in any region) to 20 (patch staining in all five regions). The corneal staining of the worse eye was analyzed.|Day 30|This analysis population group includes all participants who were exposed to both treatment regimens.||Units on a scale||Standard Deviation|Mean
671531|NCT01684007|Secondary|Binocular Distance Corrected Visual Acuity (logMAR) - Near (40 cm)|VA was tested binocularly using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, ETDRS chart set at 40 cm on the nearpoint rod. VA was measured in logMAR increments, with 0.1 logMAR corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value denotes better visual acuity.|Day 90 from second eye implantation|This analysis population includes all subjects with both eyes implanted.||logMAR||Standard Deviation|Mean
671532|NCT01684007|Primary|Binocular Distance Corrected Visual Acuity (logMAR) - Intermediate (60 cm)|Visual acuity (VA) was tested binocularly (both eyes together) using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart set at 60 centimeters (cm) on the nearpoint rod. VA was measured in logarithm minimum angle of resolution (logMAR) increments, with 0.1 logMAR corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value denotes better visual acuity.|Day 90 from second eye implantation|This analysis population includes all subjects with both eyes implanted.||logMAR||Standard Deviation|Mean
671533|NCT01683838|Secondary|Adjusted Mean Change in Subject Bowel Function Diary Scores|"Bowel questions pertaining to the average number of minutes per day spent on bowel routine were asked of all patients daily.
A negative change in patient bowel function diary score signifies improvement."|Baseline (visit 1) average score obtained at day 1 and double-blind treatment period (visits 4-7) average score days 28-98|ITT Population. Number of participants analyzed is number of patients with available data at both baseline and double-blind treatment period.||minutes||Standard Error|Mean
671534|NCT01683838|Secondary|Adjusted Mean Change in Subject Bladder/Bowel Function Diary Scores|"Bowel/bladder questions pertaining to the average number of times per day the patient experienced accidental urination/leakage and the average number of bowel movements per day were asked of all patients daily.
A negative change in patient bladder/bowel function diary score signifies improvement."|Baseline (visit 1) average score obtained at day 1 and double-blind treatment period (visits 4-7) average score days 28-98|ITT Population. Number of participants analyzed is number of patients with available data at both baseline and double-blind treatment period.||episodes||Standard Error|Mean
676491|NCT01624168|Primary|Retention of Randomized Subjects During Intervention|Retained subjects are those who are willing to return for complete assessments|10 weeks|||participants|||Number
671535|NCT01683838|Secondary|Change From Baseline in Mean Female Sexual Function Index (FSFI) Scores|"The FSFI is a brief, reliable, and valid self-administered questionnaire of 19 questions (items). It contains six domains: Desire (2 items score range: 1 Very low or none at all to 5 Very high), Arousal (4 items score range: 0 No sexual activity to 5 Almost always or always), Lubrication (4 items score range: 0 No sexual activity to 5 Almost always or always), Orgasm (3 items score range: 0 No sexual activity to 5 Almost always or always), Satisfaction (3 items score range: 0 No sexual activity to 5 Very satisfied) and Pain (3 items score range: 0 Did not attempt intercourse to 5 Almost never or never).
A positive change signifies improvement."|Baseline (visit 1) average score obtained at day 1 and stable treatment period (visits 4-7) average score days 28-98|||units on a scale||Standard Error|Mean
671536|NCT01683838|Secondary|Change From Baseline in Mean International Index of Erectile Function (IIEF) Score|"Male patients were asked to complete the IIEF questionnaire on sexual function. The IIEF is a brief, reliable, and valid self-administered questionnaire of 15 questions (items) that were categorized into five domains: Erectile Function (EF) scores: 0-6 Severe dysfunction, 7-12 Moderate dysfunction, 13-18 Mild to moderate dysfunction, 19-24 Mild dysfunction, 25-30 No dysfunction. Orgasmic Function (OF) score range: 0-2 Severe dysfunction to 9-10 No dysfunction, Sexual Desire (SD) score range: 0-2 Severe dysfunction to 9-10 No dysfunction, Intercourse Satisfaction (IS) score range: 0-3 Severe dysfunction to 13-15 No dysfunction, and Overall Satisfaction (OS) score range: 0-2 Severe dysfunction to 9-10 No dysfunction.
Domain scores were derived by summing the individual items within a given domain. Final scale ranges from 0 (negative) to 5 (positive). A positive change in IIEF domain scores signifies improvement."|Baseline (visit 1) average score obtained at day 1 and stable treatment period (visit 7) average score day 98|ITT Population. N = number of participants analyzed with available data at both baseline and stable treatment period.||units on a scale||Standard Error|Mean
671537|NCT01683838|Secondary|Stable-dose Change From Baseline in Mean American Spinal Injury Association(ASIA) Total Motor Score|Ten key muscle groups for the right and left sides were rated on a 0 (absent) to 5 (normal) scale, with a possible total score of 100. Higher positive change scores indicate improved motor function.|Baseline (visits 2,3) average score days 7,14 and stable-dose treatment period (visits 5-7) average score days 56-98|ITT Population. Number of participants analyzed is number of patients with available data at both baseline and stable-blind treatment period.||units on a scale||Standard Error|Mean
671538|NCT01683838|Secondary|Double-blind Change From Baseline in Mean Clinician's Global Impression (CGI) Scores|The supervising clinician rated the patient’s neurological condition following treatment as compared to the screening visit on a seven-point scale (from 1=very much improved to 7=very much worse). The assessment was based on the clinician’s overall impression of the patient’s neurological status (specifically bowel, bladder, and sexual function; spasticity; and other neurological functions) and general state of health related to his or her participation in the study. Negative change scores indicated a change for the better.|Baseline (visits 2,3) average of days 7-14 and double-blind treatment period (visits 4-7) average of days 28-98)|ITT Population. Number of participants analyzed is number of patients with available data at both baseline and double-blind treatment period.||units on a scale||Standard Error|Mean
671539|NCT01683838|Secondary|Double-blind Change From Baseline in Mean Spasm Frequency/Severity Scores|"The Spasm Frequency score is the average rating by the clinician of the left and right arm(s) and leg(s), each evaluated on a 4-point scale (from 0=no spasms to 4=spontaneous spasms occurring more than ten times per hour), with higher scores denoting a greater degree of muscle spasms.
The Spasm Severity score is the average rating of the left and right arm(s) and leg(s), each evaluated on a three-point scale (mild, moderate, or severe) as rated by the clinician on the basis of patient self-report.
On both, a negative change in score signifies improvement in muscle spasms. The average Spasm Frequency/Spasm Severity Score was calculated as the average of the left and right non-missing scores."|Baseline (visits 2,3) average score days 7,14 and double-blind treatment period (visits 4-7) average score days 28-98|ITT Population. Number of participants analyzed is number of patients with available data at both baseline and double-blind treatment period.||units on a scale||Standard Error|Mean
671540|NCT01683838|Primary|Double-blind Change From Baseline in Mean Subject's Global Impression (SGI) Scores|"The SGI is a 7-unit ordinal scale used by the subject to evaluate the effects of study medication on his/her quality of life during the preceding week, with higher scores denoting greater satisfaction. A positive change score in SGI signifies improved outcome.
The questionnaire consisted of one question (How do you feel about the effects of the investigational drug over the past 7 days?). The answer was based on a numerical rating scale where 1=terrible; 2=unhappy; 3=mostly dissatisfied; 4=neutral/mixed; 5=mostly satisfied; 6=pleased; 7=delighted."|Baseline (visits 2,3) average score days 7,14 and double-blind treatment period (visits 4-7) average score days 28-98|ITT population. Number of participants analyzed is number of patients with available data at both baseline and double-blind treatment period.||units on a scale||Standard Error|Mean
671541|NCT01683838|Primary|Double-blind Change From Baseline in Ashworth Score Evaluating Spasticity|"The Ashworth evaluates the functioning of two lower extremity muscle groups, the hamstring and quadriceps muscles, while in the supine position. The test measures extension of the right and left hamstring muscle and flexion of the right and left quadriceps muscle using the following 5-point grading scale:
1=no increased tone; 2=slight increase in tone, giving a catch when the affected part is moved in flexion or extension; 3=more marked increase in tone, but affected part is easily flexed; 4=considerable increase in tone, passive movement is difficult; 5=affected part is rigid in flexion and extension.
The Ashworth Score was determined by adding all individual scores for each muscle group and dividing by four. Higher Ashworth Scores indicated greater spasticity."|Baseline (visits 2,3) average score days 7,14 and double-blind treatment period (visits 4-7) average score days 28-98|Intent to Treat (ITT) Population. Number of participants analyzed is number of patients with available data at both baseline and double-blind treatment period.||units on a scale||Standard Error|Mean
671542|NCT01683812|Secondary|Cranial Measurement Description|To describe infant head shape, the study will use cranial measurements and laser head scans in a sample of prematurely born Neonatal Intensive Care (NICU) or Special Care Nursery (SCN) patients with dolichocephaly. Cranial measurement used is cranial index, an objective measure that quantifies head shape by dividing the head width (M-L) by length (A-P) then multiplying it by 100%. Measurements and scans will be taken directly following study enrollment and discharge to document head shape pre and post intervention. The discharge measure will be obtained at approximately 2 weeks-4 months of age at hospital discharge.|Using head measurements obtained at timepoint 1 enrollment (baseline, day 1) and at timepoint 2 discharge (14-120 days)|||cranial index %||Full Range|Median
671543|NCT01683812|Primary|Feasibility and Safety|Nurses will complete daily logs indicating the number of desaturation events (oxygen saturation of < 90 percent for infant corrected to full term or < 87 percent for a premature infant for > 10 seconds) and emesis events (regurgitation of breast milk or formula) during cranial cup device use. The cup's designated use is for at least 12 hours per day. Study duration is at least 14 days and can continue until the infant is discharged. Comparisons will be made for the number of desaturation events and emesis during data analysis.|Logs of cranial cup use and desaturation and emesis events will be recorded for 14 -120 days|||count||Full Range|Median
671544|NCT01683630|Primary|Risk of Death Due to Any Cause During 30 Days Following the Index Date of Laboratory Confirmed Cases of Influenza A and B in the Province of Manitoba||Upto 15 years|||percentage of participants|||Number
671545|NCT01683630|Primary|Percentage of Participants With a Risk of Hospitalization Due to Any Diagnosis Within 30 Days Following the Index Date of Confirmed Cases of Influenza A and B in the Province of Manitoba||upto 15 years|||Percentage of participants|||Number
671546|NCT01683630|Primary|Age Adjusted Percentage of Participants With a Physician Visit Due to Any Diagnosis Within 30 Days of the Index Date of the Confirmed Influenza A and B Cases in the Province of Manitoba||up to 15 years|||Percentage of participants||95% Confidence Interval|Number
671547|NCT01683604|Secondary|Change From Baseline in Participant Assessment of Morning Stiffness Using VAS at Months 3 and 6|The participant assessment of morning stiffness was measured using a ruler on a 100 mm VAS, where the responses were on a continuous range from 0 = no stiffness and 100 = maximum stiffness.|Baseline, Month 3, Month 6|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with available data at the specified visit.||mm||Standard Deviation|Mean
671548|NCT01683604|Secondary|Change From Baseline in Patient's Assessment of Pain at Months 3 and 6|Participants measured the pain intensity due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 = no pain to 100 = unbearable pain.|Baseline, Month 3, Month 6|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n = participants with available data for the specified visit.||mm||Standard Deviation|Mean
671549|NCT01683604|Secondary|Change From Baseline in VAS-Fatigue at Months 3 and 6|Participants measured the level of fatigue due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 = no fatigue to 100 = extreme fatigue.|Baseline, Month 3, Month 6|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with available data at the specified visit.||mm||Standard Deviation|Mean
671550|NCT01683604|Secondary|Change From Baseline in HAQ-DI Score at Months 3 and 6|The HAQ-DI is a questionnaire that measures functional status (disability) and health-related quality of life. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities over past week. Each question was evaluated according to the degree of severity on a 4-point scale ranging from 0 = without any difficulty to 3 = unable to do. Total score is the sum of each question, which ranges from 0 to 60, where higher scores represent higher disease activity. The change from baseline in HAQ-DI score at Month 3 and Month 6 was calculated as the difference between HAQ­D1 score reported at baseline and the HAQ­D1 score reported at Month 3 and Month 6.|Baseline, Month 3, Month 6|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n = participants with available HAQ-DI score at specified visit.||units on a scale||Standard Deviation|Mean
671551|NCT01683604|Secondary|Change From Baseline in Patient Global Assessment of Disease Activity at Months 3 and 6|The patient's global assessment of disease activity was measured using a 100 mm VAS, where the responses were on a continuous range from 0= managing very well and 100 = managing very poorly.|Baseline, Month 3, Month 6|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with available data at the specified visit.||mm||Standard Deviation|Mean
671552|NCT01683604|Secondary|Change From Baseline in Physician Global Assessment of Disease Activity at Months 3 and 6|The physician global assessment of disease activity was evaluated using a 100 mm VAS where 0 = no arthritis activity and 100 = extremely active arthritis. Higher scores indicated increased level of disease.|Baseline, Month 3, Month 6|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with available data at the specified visit.||mm||Standard Deviation|Mean
671553|NCT01683604|Secondary|Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, or 70% (ACR20/50/70) Response at Month 3 and Month 6 From the Start of Tocilizumab Treatment|ACR 20,50 or 70 response=an improvement of ≥ 20%, ≥ 50% or ≥ 70% respectively, as compared to baseline in TJC28 and SJC28, and 20%, 50% or 70% improvement in at least 3 of the 5 following measures: Patient's Assessment of Pain over the previous 24 hours, PGA, PhGA, HAQ, and acute phase reactant (either CRP or ESR). TJC and SJC, based on 28-joint assessments. Number of tender joints and swollen joints were recorded on the joint assessment form at baseline, no tenderness = 0 and tenderness = 1, no swelling = 0 and swelling =1, respectively. HAQ measures functional status (disability) and health-related quality of life with 20 questions, summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities over past week, 0=without difficulty to 3=unable to do. Patient's assessment of pain assessed using a VAS; 0=no pain, 100=unbearable pain; PGA and PhGA, assessed using VAS ; 0= no disease activity, 100=maximum disease activity.|Month 3 and Month 6|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with available data for the specified visit.||percentage of participants||95% Confidence Interval|Number
671572|NCT01683604|Primary|Erythrocyte Sedimentation Rate (ESR) at Baseline|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeters per hour (mm/hr). A decrease in the level indicates reduction in inflammation and therefore improvement.|Baseline|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure.||mm/hr||Standard Deviation|Mean
671636|NCT01682876|Secondary|Number of Subjects Who Reported Selected AEs After Any Vaccination|Safety was assessed as the number subjects who reported Selected AEs from day 1 up to day 86 after one or two vaccination(s) of MenACWY-CRM|Day 1 to Day 86|Analysis was done on Safety Set Unsolicited AEs||Subjects|||Number
671554|NCT01683604|Secondary|Simplified Disease Activity Index (SDAI) Score by Visit|The SDAI is a combined index for measuring disease activity in RA and calculated as SDAI = TJC28 + SJC28 + PGH (in centimeters) + PhGH (in centimeters) + CRP (in mg/dL), where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly, PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 = no arthritis activity and 100 = extremely active arthritis, CRP = serum concentration of c-reactive protein; with a total SDAI score ranged from 0-86. Higher scores indicate greater disease activity. SDAI scores of less than or equal to 3.3 represents clinical remission, less than or equal to 11.0 represents low disease activity, less than or equal to 26.0 represents moderate disease activity, and greater than 26.0 represents high (or severe) disease.|Baseline, Month 3, Month 6|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with SDAI score available at the specified visit.||units on a scale||Standard Deviation|Mean
671555|NCT01683604|Secondary|Change From Baseline in TJC and SJC at Month 3 and Month 6|TJC was determined by examining 28 and 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at baseline, no tenderness = 0, tenderness = 1. SJC was determined by examination of 28 and 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at baseline, no swelling = 0, swelling =1.|Baseline, Month 3, Month 6|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with available data at the specified visit.||joint counts||Standard Deviation|Mean
671556|NCT01683604|Secondary|Clinical Disease Activity Index (CDAI) Score by Visit|The CDAI is a combined index for measuring disease activity in RA and calculated as CDAI = TJC28 + SJC28 + PGH (in centimeters) + PhGH (in centimeters), where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly, and PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 = no arthritis activity and 100 = extremely active arthritis; with a total score ranged from 0-76. Higher scores indicate greater disease activity. CDAI score of less than or equal to 2.8 represents clinical remission, score of less than or equal to 10.0 represents low disease activity, score of less than or equal to 22.0 represents moderate disease activity, and score of greater than 22.0 represents high (or severe) disease.|Baseline, Month 3, Month 6|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with CDAI score available at specified visit.||units on a scale||Standard Deviation|Mean
671557|NCT01683604|Secondary|Percentage of Participants Achieving Good European League Against Rheumatism (EULAR) Response at Month 3 and Month 6|Clinical response was assessed according to EULAR criteria that classified the participant according to individual changes in DAS28 score as good, moderate, or no response. The DAS28 score is a measurement of RA activity on a 0 to 10 scale, with higher scores represent higher disease activity, and calculated as DAS28 = 0.56 x √TJC28 + 0.28 x √SJC28 + 0.36 x ln(CRP + 1) + 0.014 x PGH + 0.96, where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, CRP = serum concentration of c­reactive protein (after converting units to mg/dL), PGH = patient's global assessment of disease activity, which was measured on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly. Good responders experienced a change from baseline of greater than 1.2 with a DAS28 score less than or equal to 3.2.|Month 3 and Month 6|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with EULAR response available at specified visit.||percentage of participants|||Number
671558|NCT01683604|Secondary|Disease Activity Score Based on 28 Joint Count (DAS28) Score by Visit|The DAS28 score is a measurement of RA activity on a 0 to 10 scale, with higher scores representing higher disease activity, and calculated as DAS28 = 0.56 x √TJC28 + 0.28 x √SJC28 + 0.70 x natural logarithm (ln) (CRP + 1) + 0.014 x PGH + 0.96, where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, CRP = serum concentration of c-reactive protein (after converting units to mg/dL), PGH = patient global assessment of disease activity, which was measured on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly. A score of less than 2.6 represents clinical remission, a score of greater than or equal to 2.6 and less than or equal to 3.2 represents low disease activity, a score of greater than 3.2 and less than or equal to 5.1 represents moderate disease activity, and a score of greater than 5.1 represents high (or severe) disease.|Baseline, Month 3, Month 6|FAS population. Here, Number of participants analyzed = Participants evaluable for the outcome measure and n= participants with DAS28 score available at the specified visit.||units on a scale||Standard Deviation|Mean
671559|NCT01683604|Secondary|Percentage of Participants Adhering to Local Label for Adverse Events|Percentage of participants who adhered to local label/protocol for the management of adverse events is reported.|Baseline up to Month 6|FAS population. Number of participants analyzed = participants with available data for this outcome measure.||percentage of participants|||Number
671560|NCT01683604|Secondary|Percentage of Participants With and Without Morning Stiffness|"Morning stiffness was defined by the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant assessed morning stiffness based on the following criteria:
Presence of participant's joints stiff when woke up that day, measured as yes or no
Duration of morning stiffness, measured using a ruler on a 100 mm VAS by 1 of the six categories: < 30 minutes, between 30 and 240 minutes, > 240 minutes, and the whole day.
Severity of morning stiffness measured using a ruler on a 100 mm VAS where the responses were on a continuous range from 0 = no stiffness to 100 = maximum stiffness."|Baseline, Month 3, Month 6|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with available data at the specified visit.||percentage of participants|||Number
671561|NCT01683604|Secondary|Percentage of Participants by Duration of Morning Stiffness|Duration of morning stiffness was defined as the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant assessment of morning stiffness was measured using a ruler on a 100 mm VAS by 1 of the six categories: less than (<) 30 minutes, between 30 and 240 minutes, greater than (>) 240 minutes and whole day.|Baseline, Month 3, Month 6|FAS population. Here, n= participants with available data at specified visit.||percentage of participants|||Number
671573|NCT01683604|Primary|Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Baseline|TJC was determined by examining 28 and 68 joints and identifying the joints that were painful under pressure or to passive motion. Tenderness was recorded on the joint assessment form at baseline, no tenderness = 0, tenderness = 1. SJC was determined by examining 28 and 66 joints and identifying when swelling was present. Swelling was recorded on the joint assessment form at baseline, no swelling = 0, swelling =1.|Baseline|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with available data for the specified category.||joint counts||Standard Deviation|Mean
671574|NCT01683604|Primary|Health Assessment Questionnaire Disability Index (HAQ-DI) Scores at Baseline|The HAQ-DI is a questionnaire that measures functional status (disability) and health-related quality of life. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common activities over past week. Each question is evaluated according to the degree of severity on a 4-point scale. Total score for HAQ-DI is the average of all questions and ranges from 0 = without any difficulty to 3 = unable to do.|Baseline|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure.||units on a scale||Standard Deviation|Mean
671575|NCT01683604|Primary|Physician Global Assessment of Disease Activity Using VAS at Baseline|Physician global assessment of disease activity was assessed on a 100 mm VAS, where 0 = no arthritis activity to 100 = extremely active arthritis.|Baseline|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure.||mm||Standard Deviation|Mean
671576|NCT01683604|Primary|Patient Global Assessment of Disease Activity Using VAS at Baseline|The patient's global assessment of disease activity was measured using a 100 mm VAS, where the responses were on a continuous range from 0 = managing very well to 100 = managing very poorly.|Baseline|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure.||mm||Standard Deviation|Mean
671577|NCT01683604|Primary|Patient Assessment of Pain Using Visual Analog Scale (VAS) at Baseline|Participants measured the pain intensity due to RA on a 100 millimeter (mm) VAS, where the responses were on a continuous range from 0 = no pain to 100 = unbearable pain.|Baseline|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure.||millimeters (mm)||Standard Deviation|Mean
671578|NCT01683604|Primary|Percentage of Participants on Tocilizumab Treatment at Month 6 After Treatment Initiation|Percentage of participants on tocilizumab treatment at Month 6 was calculated as: [(participants on tocilizumab treatment at Month 6) divided by (participants evaluable for primary objective)] multiplied by 100.|Month 6|FAS population||percentage of participants|||Number
671579|NCT01683526|Secondary|Complications of Intubation|Complications of intubation including aspiration, vomiting, esophageal intubation,and dental injury.|For 10 minutes post intubation|||percentage of other complications|||Number
671580|NCT01683526|Secondary|Cardiac Arrest||For 1 hour post intubation|||percentage of cardiac arrest|||Number
671581|NCT01683526|Secondary|Hypotension|SBP<70|For 10 minutes post intubation|||percentage of hypotension|||Number
671582|NCT01683526|Secondary|Severe Desaturation|sat <80%|For 10 minutes post intubation|||percentage of patients with desaturation|||Number
671583|NCT01683526|Primary|First Pass Success Rate||From begining of intubation to verification. Less then 5 minutes approximatly|||percentage of first pass success|||Number
671584|NCT01683409|Secondary|Pharmacokinetics (PK): Area Under the Concentration-Time Curve at Steady State (AUC,ss)|Evaluable pharmacokinetic concentrations from the 2-week, 4-week, 8-week, 12-week, 16-week, 20-week and 24-week time points were combined and utilized in a population approach to determine the population mean estimate and standard deviation at steady-state.|Weeks 2 and 4 (1-2 hours postdose), 8 (3-6 hours postdose), 12 (in fasted state), 16 and 20 (6-9 hours postdose), 24 (in fasted state)|All randomized participants who received at least one dose of study drug and had evaluable PK data.||nanomole*hour (nM*hr)||Standard Deviation|Mean
671585|NCT01683409|Secondary|Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) at Week 24|EQ-5D-5L is a 2-part measurement. The first part is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1. A higher score indicates better health state. The second part is assessed using a visual analog scale (VAS) that ranged from 0 to 100mm, where 0 is the worst health you can imagine and 100 is the best health you can imagine. The LS means are analyzed using an analysis of covariance (ANCOVA) model with treatment, baseline eGFR group, and baseline VAS score or baseline health state index score as covariates.|Baseline, Week 24|All randomized participants who received at least one dose of study drug. Missing values were imputed with the last observation carried forward (LOCF) method.||Units on a Scale||Standard Error|Least Squares Mean
671586|NCT01683409|Secondary|Change From Baseline in Creatinine Clearance at Week 24|Creatinine clearance is the amount of creatinine cleared from kidney within 24 hours. The LS mean was from MMRM analyses which included treatment, baseline eGRF group, visit, treatment-by-visit interaction, baseline Creatinine Clearance, and baseline Creatinine Clearance-by-visit interaction.|Baseline, Week 24|All randomized participants who received at least one dose of study drug.||milliliter/minute (mL/min)||Standard Error|Least Squares Mean
671587|NCT01683409|Secondary|Change From Baseline in Urinary Monocyte Chemotactic Protein 1 (MCP-1)/Creatinine Ratio||Baseline, Week 24|Zero participants analyzed. No data analyzed due to urinary MCP-1 and creatinine being measured on different urine samples from different time points and thus not able to correlate.|||||
671588|NCT01683409|Primary|Change From Baseline in Urinary Albumin/Creatinine Ratio (UACR) at Week 24|UACR is a potential marker of chronic kidney disease, calculated as a ratio of Urinary Albumin and Urinary Creatinine. The least squares mean (LS mean) are from mixed model repeated measures (MMRM) analyses which include treatment, baseline estimated Glomerular Filtration Rate (eGFR) group (higher: 50 to 70 mL/min/1.73m² and lower: 25 to <50 mL/min/1.73m²), visit, treatment-by-visit interaction, baseline UACR, and baseline UACR-by-visit interaction.|Baseline, Week 24|All randomized participants who received at least one dose of study drug.||milligram/gram (mg/g)||Standard Error|Least Squares Mean
671589|NCT01683383|Other Pre-specified|Safety Outcomes|The incidence, intervention and outcome of cardiac arrhythmia, major bleeding, altered skin integrity, pulmonary hypertension, device-related events, death, and other serious adverse events from the time of initiation of transport cooling to the time of completion will be monitored.|Participants will be followed for the duration of neonatal transport from the birth hospital to the cooling center, an expected average of 4 hours|Total participants in each study arm||Participants|||Number
671590|NCT01683383|Secondary|Participants in Target Temperature Range Anytime During Transport|Participants in target temperature range (33-34 C) anytime during transport|Participants will be followed for the duration of neonatal transport from the birth hospital to the cooling center, an expected average of 4 hours|Total participants in each study arm||Participants|||Number
671591|NCT01683383|Secondary|Percentage of Participants in the Target Range at 1 Hour|Percentage of participants in target range (33°-34°C) one hour after cooling initiation by the transport team|Participants will be followed for the duration of neonatal transport from the birth hospital to the cooling center, an expected average of 4 hours|Total participants in each study arm, excluding 8 participants in the control arm and 12 participants in the device arm who completed transport in < 1 hour.||Percentage of participants|||Number
671592|NCT01683383|Secondary|Time to Target Temperature|Time to the target temperature range (33°-34°C) from initiation of cooling by the transport team|Participants will be followed for the duration of neonatal transport from the birth hospital to the cooling center, an expected average of 4 hours|Total patients in each study arm||Minutes||Standard Deviation|Mean
671593|NCT01683383|Primary|Percentage of Temperatures in Target Range During Transport|The percentage of temperatures in the target range (33°-34°C) during transport after cooling initiation by the transport team.|Participants will be followed for the duration of neonatal transport from the birth hospital to the cooling center, an expected average of 4 hours|Total patients in each study arm||Percentage of temperatures||Inter-Quartile Range|Median
671594|NCT01683266|Secondary|Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline to Month 12|Hypoglycemia events were Severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); Documented symptomatic hypoglycemia (typical symptoms of hypoglycemia with plasma glucose level of <=3.9 mmol/L [70 mg/dL]); Asymptomatic hypoglycemia (no typical symptoms of hypoglycemia but plasma glucose level <=3.9 mmol/L); Probable symptomatic hypoglycemia (an event during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination, but was presumably caused by a plasma glucose level <=3.9 mmol/L, symptoms treated with oral carbohydrate without a test of plasma glucose); Relative hypoglycemia (an event during which the person with diabetes reported any of the typical symptoms of hypoglycemia, and interpreted the symptoms as indicative of hypoglycemia, but plasma glucose level >3.9 mmol/L); Severe and/or confirmed a hypoglycemia (plasma glucose <=3.9 mmol/L).|Up to Month 12|Safety population: all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. In the event of participants having received treatments different from those assigned according to the randomization schedule, safety analyses were conducted according to treatment received.||percentage of participants|||Number
671595|NCT01683266|Secondary|Change in Total Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint|DTSQ is a validated measure to assess how satisfied participants with diabetes are with their treatment and how they perceive hyper­ and hypoglycemia. It consists of 8 questions which are answered on a Likert scale from 0 to 6. DTSQ treatment satisfaction score is the sum of question 1 and 4­8 scores and ranges between 0 and 36, where higher scores indicate more treatment satisfaction.|Baseline, Month 6|mITT Population. Number of participants analyzed = participants with Baseline and Month 6 DTSQ assessment.||units on a scale||Standard Error|Least Squares Mean
671596|NCT01683266|Secondary|Change in Daily Average Total Insulin Dose From Baseline to Month 6 Endpoint||Baseline, Month 6|mITT Population. Number of participants analyzed = participants with Baseline and Month 6 daily average total insulin dose assessment.||U/kg||Standard Deviation|Mean
671597|NCT01683266|Secondary|Change in 8-­Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint|Change in each time­point of 8-point SMPG profile: 03:00 hours (clock time) at night; before and 2 hours after breakfast; before and 2 hours after lunch; before and 2 hours after dinner; and at bedtime.|Baseline, Month 6|mITT Population. Here, n = participants with Baseline and Month 6 8­point SMPG assessment separately for each analysed time point.||mmol/L||Standard Deviation|Mean
671598|NCT01683266|Secondary|Percentage of Participants With FPG <7.2 mmol/L (130 mg/dL) at Month 6 Endpoint||Month 6|mITT Population. Number of participants analyzed = participants with baseline and Month 6 FPG assessment.||percentage of participants|||Number
671599|NCT01683266|Secondary|Percentage of Participants With Fasting Plasma Glucose (FPG) <5.6 mmol/L (100 mg/dL) At Month 6||Month 6|mITT Population.||percentage of participants|||Number
671600|NCT01683266|Secondary|Change in Fasting Plasma Glucose From Baseline to Month 6 Endpoint||Baseline, Month 6|mITT Population. Number of participants analyzed = participants with baseline and Month 6 FPG assessment.||mmol/L||Standard Error|Least Squares Mean
671601|NCT01683266|Secondary|Change in Variability of Pre-injection SMPG From Baseline to Month 6 Endpoint|Pre­injection SMPG was measured within 30 minutes prior to the injection of the study drug. Variability was assessed by the mean of coefficient of variation calculated as 100 multiplied by (standard deviation/mean) over at least 3 SMPG measured during the 7 days preceding the assessment visit.|Baseline, Month 6|mITT population. Number of participants analyzed = participants with baseline and Month 6 pre­injection SMPG assessment.||percentage of mean||Standard Error|Least Squares Mean
671602|NCT01683266|Secondary|Change In Average Pre-Injection Self-Monitored Plasma Glucose (SMPG) From Baseline Month 6 Endpoint|Pre­injection SMPG was measured within 30 minutes prior to the injection of the study drug. Average was assessed by the mean of at least 3 SMPG calculated over the 7 days preceding the assessment visit.|Baseline, Month 6|mITT population. Number of participants analyzed = participants with baseline and Month 6 pre­injection SMPG assessment.||millimole per liter (mmol/L)||Standard Error|Least Squares Mean
671603|NCT01683266|Secondary|Percentage of Participants With HbA1c Less Than or Equal to 6.5% at Month 6 Endpoint||Month 6|mITT Population.||percentage of participants|||Number
671604|NCT01683266|Secondary|Percentage of Participants With HbA1c <7% at Month 6 Endpoint||Month 6|mITT Population.||percentage of participants|||Number
671605|NCT01683266|Primary|Change In HbA1c From Baseline to Month 6 Endpoint||Baseline, Month 6|Modified Intent-to-Treat (mITT) population: all randomized participants who received at least (>=)1 dose, had baseline and >=1 post­baseline assessment of any efficacy variable, irrespective of compliance. Number of participants analyzed = participants with baseline and Month 6 HbA1c assessment.||percentage of hemoglobin||Standard Error|Least Squares Mean
671606|NCT01683058|Secondary|Number of Participants With Clinically Relevant Physical Examination.|The physical examination evaluation was one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in the following body systems: head, ears, eyes, nose, and throat; thorax; abdomen; urogenital; extremities; neurological; and skin and mucosae.|Baseline to last visit|All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit). None of the abnormalities or findings were noted during physical examination were considered clinically relevant.||participants|||Number
671607|NCT01683058|Secondary|Number of Participants With Clinically Relevant Laboratory Values.|The laboratory values were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal values in serum chemistry, hematology, urinalyses and prolactin tests that were identified based on pre-defined criteria.|Baseline to last visit|All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit). There were no clinically relevant findings with regard to laboratory values reported in this study.||participants|||Number
671608|NCT01683058|Secondary|Mean Change in Clinically Relevant Waist Circumference From Baseline in All Participants.|Clinically relevant waist circumference was one of the primary parameters to measure the safety and tolerability of individual participants. Each participant's body mass index (BMI) kilogram per square meter (kg/m2) were calculated from the screening. Body weight, BMI, and waist circumference changes were evaluated by calculating mean change from Baseline and by tabulating the incidence of ≥7% weight gain or loss.|Baseline to last visit|Safety Sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit). Only Week 24 and last visit data was included.||cm||Standard Deviation|Mean
671609|NCT01683058|Secondary|Mean Change in Clinically Relevant Body Mass Index From Baseline in All Participants.|Clinically relevant body mass index was one of the primary parameters to measure the safety and tolerability of individual participants. Each participant's body mass index (BMI) kilogram per square meter (kg/m2) were calculated from the screening. Body weight, BMI, and waist circumference changes were evaluated by calculating mean change from Baseline and by tabulating the incidence of ≥7% weight gain or loss.|Baseline to last visit|Safety Sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).||Kg/m2||Standard Deviation|Mean
671610|NCT01683058|Secondary|Mean Change in Clinically Relevant Body Weight Changes From Baseline in All Participants.|Clinically relevant body weight changes was one of the primary parameters to measure the safety and tolerability of individual participants. Each participant's body mass index (BMI) kilogram per square meter (kg/m2) were calculated from the screening. Body weight, BMI, and waist circumference changes were evaluated by calculating mean change from Baseline and by tabulating the incidence of ≥7% weight gain or loss.|Baseline to last visit|Safety Sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).||Kg||Standard Deviation|Mean
671611|NCT01683058|Secondary|Mean Change in QTcN Interval From Baseline in All Participants.|The measurement QTcN interval is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, RR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria.|Baseline to last visit|Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).||msec||Standard Deviation|Mean
671612|NCT01683058|Secondary|Mean Change in QTcF Interval From Baseline in All Participants.|The measurement QTcF interval is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, RR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria.|Baseline to last visit|Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).||msec||Standard Deviation|Mean
671613|NCT01683058|Secondary|Mean Change in QTcB Interval From Baseline in All Participants.|The measurement QTcB interval is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, RR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria.|Baseline to last visit|Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).||msec||Standard Deviation|Mean
671614|NCT01683058|Secondary|Mean Change in QT Interval From Baseline in All Participants.|The measurement QT interval is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, RR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria.|Baseline to last visit|Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).||msec||Standard Deviation|Mean
671615|NCT01683058|Secondary|Mean Change in QRS Interval From Baseline in All Participants.|The measurement QRS interval is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria.|Baseline to last visit|Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).||msec||Standard Deviation|Mean
671616|NCT01683058|Secondary|Mean Change in RR Interval From Baseline in All Participants.|The measurement RR interval is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria.|Baseline to last visit|Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).||msec||Standard Deviation|Mean
671617|NCT01683058|Secondary|Mean Change in PR Interval From Baseline in All Participants.|The measurement PR interval is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria.|Baseline to last visit|Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).||msec||Standard Deviation|Mean
671618|NCT01683058|Secondary|Mean Change in Ventricular Rate From Baseline in All Participants.|The measurement ventricular rate is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, RR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria.|Baseline to last visit|Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).||Beats/min||Standard Deviation|Mean
671619|NCT01683058|Secondary|Mean Change in Diastolic BP From Baseline in All Participants.|The diastolic sitting BP, which is a vital sign parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of treatment-emergent adverse events of potential clinical relevance included abnormal values in body temperature, heart rate, systolic and diastolic blood pressure and respiratory rate that were identified based on pre-defined criteria. Orthostatic assessments of blood pressure and heart rate were made after the participant was supine for at least 5 minutes and again after the participant was sitting for approximately 2 minutes.|Baseline to last visit|Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).||mmHg||Standard Deviation|Mean
671620|NCT01683058|Secondary|Mean Change in Systolic BP From Baseline in All Participants.|The systolic sitting BP, which is a vital sign parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of treatment-emergent adverse events of potential clinical relevance included abnormal values in body temperature, heart rate, systolic and diastolic blood pressure and respiratory rate that were identified based on pre-defined criteria. Orthostatic assessments of blood pressure and heart rate were made after the participant was supine for at least 5 minutes and again after the participant was sitting for approximately 2 minutes.|Baseline to last visit|Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).||mmHg||Standard Deviation|Mean
671621|NCT01683058|Secondary|Mean Change in Heart Rate From Baseline in All Participants.|The heart rate sitting, which is a vital sign parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of treatment-emergent adverse events of potential clinical relevance included abnormal values in body temperature, heart rate, systolic and diastolic blood pressure and respiratory rate that were identified based on pre-defined criteria. Orthostatic assessments of blood pressure and heart rate were made after the participant was supine for at least 5 minutes and again after the participant was sitting for approximately 2 minutes.|Baseline to last visit|Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).||beats/min||Standard Deviation|Mean
671622|NCT01683058|Secondary|Mean Change in Diastolic Supine BP From Baseline in All Participants.|The diastolic supine BP, which is a vital sign parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of treatment-emergent adverse events of potential clinical relevance included abnormal values in body temperature, heart rate, systolic and diastolic blood pressure and respiratory rate that were identified based on pre-defined criteria.|Baseline to last visit|Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).||mmHg||Standard Deviation|Mean
671623|NCT01683058|Secondary|Mean Change in Systolic Supine Blood Pressure (BP) From Baseline in All Participants.|The systolic supine BP, which is a vital sign parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of treatment-emergent adverse events of potential clinical relevance included abnormal values in body temperature, heart rate, systolic and diastolic blood pressure, and respiratory rate that were identified based on pre-defined criteria.|Baseline to last visit|Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).||mmHg||Standard Deviation|Mean
671624|NCT01683058|Secondary|Mean Change in Heart Rate Supine From Baseline in All Participants.|The heart rate supine, which is a vital sign parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of treatment-emergent adverse events of potential clinical relevance included abnormal values in body temperature, heart rate, systolic and diastolic blood pressure, and respiratory rate that were identified based on pre-defined criteria.|Baseline to last visit|Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).||beats/min||Standard Deviation|Mean
671625|NCT01683058|Secondary|Mean Change in Body Temperature From Baseline in All Participants.|The body temperature, which is a vital sign parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of treatment-emergent adverse events of potential clinical relevance included abnormal values in body temperature, heart rate, systolic and diastolic blood pressure, and respiratory rate that were identified based on pre-defined criteria.|Baseline to last visit|Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).||°C||Standard Deviation|Mean
671626|NCT01683058|Secondary|Mean Change From Baseline by Week by EPS Evaluated Using Barnes Akathisia Rating Scale (BARS)|The BARS global score (range 0-5) was derived from the global clinical assessment of akathisia from the BARS panel were, 0= absent; 1= questionable; 2= mild akathisia; 3= moderate akathisia; 4= marked akathisia; 5= severe akathisia. Patients were observed while they were seated and then standing (for a minimum of 2 minutes in each position). Symptoms were observed in other situations (e.g., while engaged in neutral conversation, engaged in activity on the ward) was also rated.|Baseline to Week 24|In safety analysis, all enrolled participants took at least one injection of aripiprazole IM depot 400/300mg in the IM depot treatment period.||Units on a scale||Standard Deviation|Mean
671627|NCT01683058|Secondary|Mean Change From Baseline by Week by EPS Evaluated Using the Abnormal Involuntary Movement Scale (AIMS)|EPS rating scale included the AIMS movement rating score (range 0-28) was the sum of the rating scores for facial and oral movements (i.e., item 1 - 4), extremity movements (i.e. item 5 - 6), and trunk movements (i.e. item 7). The symptoms for facial and oral movements were 1= muscles of facial expression, 2= lips and perioral area, 3= jaw and 4=tongue; extremity movements were, 5= upper (arms, wrists, hands, fingers), lower (legs, knees, ankles, toes), 7= neck, shoulders, hips). This scale consisted of 10 items, each to be rated on a 4-point scale of severity, and 2 questions to be answered by yes or no. To complete the scale, the patient was observed unobtrusively at rest (e.g., in waiting room). The chair used for this examination was hard, firm one without arms.|Baseline to Week 24|In safety analysis, all enrolled participants took at least one injection of aripiprazole IM depot 400/300mg in the IM depot treatment period.||Units on a scale||Standard Deviation|Mean
671628|NCT01683058|Secondary|Mean Change From Baseline by Week by Extrapyramidal Symptoms (EPS) Evaluated Using the Simpson-Angus Scale (SAS)|The EPS rating scales included SAS total score (range 10-50) was the sum of the rating scores for 10 items from the SAS panel. This scale consists of a list of 10 symptoms, each to be rated on a 5-point scale of severity. For each symptom, the rating which best described the patient's condition were, 1= gait; 2= arm dropping; 3= shoulder shaking; 4= elbow rigidity; 5= wrist rigidity; 6= head rotation; 8= tremor; 9= salivation; 10= akathisia.|Baseline to Week 24|In safety analysis, all enrolled participants took at least one injection of aripiprazole IM depot 400/300mg in the IM depot treatment period.||Units on a scale||Standard Deviation|Mean
671629|NCT01683058|Secondary|Mean Change From Baseline in Suicidal Ideation Intensity Total Score by the Columbia Suicide Severity Rating Scale (C-SSRS)|Data collected from C-SSRS were mapped into C-CASA. The Columbia Classification Algorithm of Suicide Assessment (C-CASA) method and C-SSRS(text in parentheses as said below) were mapped as; 1= completed suicide(completed suicide); 2= suicide attempt(actual attempt); 3= preparatory actions toward imminent suicidal behavior (interrupted attempt, aborted attempt and preparatory acts/behavior); 4= suicidal ideation(wish to die,active suicidal thought, active suicidal thought with method, active suicidal thought with intent,active suicidal thought with plan/intent); 5= self-injurious behavior, intent unknown; 6= not enough information: death; 7= non-suicidal self-injurious behavior(nonsuicidal self-injurious behavior); 8= other accident; psychiatric/medical; 9= not enough information/non-death. C-CASA category 5, 6, 8 and 9 are not applicable. For each item, each participant received an intensity score from 0(none) to 5(worst). Suicidal ideation intensity total score range from 0 to 25.|Baseline to Week 24|In safety analysis, all enrolled participants took at least one injection of aripiprazole IM depot 400/300mg in the IM depot treatment period.||Units on a scale||Standard Deviation|Mean
671630|NCT01683058|Primary|Percentage of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Severe TEAEs, Discontinued Investigational Medicinal Product (IMP) Due to AEs, Serious TEAEs and Outcome of Death|A TEAE was defined as an AE that began after the first injection or was continuous from Baseline and was serious, study drug-related, or resulted in death.|Baseline to Week 24|In safety analysis, all enrolled participants took at least one injection of aripiprazole IM depot 400/300mg in the IM depot treatment period.||Percentage of participants|||Number
671633|NCT01682954|Primary|Body Weight|Change in body weight|7 Months|||kg||Standard Error|Mean
671634|NCT01682954|Primary|Body Weight|Change in body weight|4 months|||kg||Standard Error|Mean
671637|NCT01682876|Secondary|Numbers of 6 to 10 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination|Safety was assessed as the number of 6 to 10 years-old subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after one or two vaccination(s) of MenACWY-CRM|From Days 1-7 after each vaccination|Analysis was done on the safety dataset||Subjects|||Number
671638|NCT01682876|Secondary|Number of 2 to 5 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination|Safety was assessed as the number of 2 to 5 years-old subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after one or two vaccination(s) of MenACWY-CRM|From Days 1-7 after each vaccination|Analysis was done on the safety dataset i.e. the subjects in the exposed population who provided postvaccination safety data.||subjects|||Number
671639|NCT01682876|Secondary|Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM|Immunogenicity was measured as hSBA GMTs and 95% CI against N. meningitidis serogroups A, C, W and Y at one year after one vaccination or two vaccinations of MenACWY-CRM.|One year after one vaccination or two vaccinations (day 422).|Analysis was done on the persistence PP dataset||Titers||95% Confidence Interval|Geometric Mean
671640|NCT01682876|Secondary|Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM|Immunogenicity was measured as the percentage of subjects with hSBA titer ≥1:8 and associated 95% CI at one year after one vaccination or two vaccinations of MenACWY-CRM.|One year after one vaccination or two vaccinations (day 422).|Analysis was done on the persistence PP dataset||percentages of subjects||95% Confidence Interval|Number
671641|NCT01682876|Secondary|Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM|Immunogenicity was measured as hSBA geometric mean titers (GMTs) and 95% CI against N. meningitidis serogroups A, C, W and Y, one month after one vaccination or two vaccinations of MenACWY-CRM.|One Month After Last Vaccination (day 86)|Analysis was done on the primary PP dataset||Titer||95% Confidence Interval|Geometric Mean
671642|NCT01682876|Secondary|Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM|Immunogenicity was measured as the percentage of subjects who achieved hSBA titer ≥1:8 and associated 95% CI, at one month after one vaccination or two vaccinations of MenACWY-CRM.|One Month After Last Vaccination (day 86)|Analysis was done on the primary PP dataset.||percentage of subjects||95% Confidence Interval|Number
671643|NCT01682876|Primary|Superiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination|Immunogenicity was measured as the percentage of subjects with overall seroresponse and associated 2-sided 95% CI, directed against N. meningitidis serogroups A, C, W and Y, by hSBA at 1 month after one vaccination or two vaccinations of MenACWY-CRM. Seroresponse -postvaccination hSBA titer ≥1:8 for subjects with a prevaccination hSBA titer <1:4 and for subjects with a prevaccination hSBA ≥1:4, an increase of at least four times of the prevaccination hSBA titer.|One Month After Last Vaccination (day 86)|Analysis was done on the FAS dataset - All subjects in the exposed dataset who provided evaluable serum samples whose assay results were available for at least 1 serogroup on day 1 and 1 post baseline visit.||percentage of subjects||95% Confidence Interval|Number
671644|NCT01682876|Primary|Non-inferiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination|"Immunogenicity was measured as the percentage of subjects with overall seroresponse and associated 2-sided 97.5% Clopper-Pearson confidence interval (CI), directed against N. meningitidis serogroups A, C, W and Y, by serum bactericidal assay using human complement (hSBA) at 1 month after one vaccination or two vaccinations of MenACWY-CRM given two months apart.
Seroresponse is defined as:
postvaccination hSBA titer ≥1:8 for subjects with a prevaccination hSBA titer <1:4;
for subjects with a prevaccination hSBA ≥1:4, an increase of at least four times of the prevaccination hSBA titer."|One Month After Last Vaccination ( day 86)|Analysis was done on the primary per-protocol (PP) dataset, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis.||percentage of subjects||95% Confidence Interval|Number
671645|NCT01682863|Secondary|Change From Baseline in the Daily Number of Puffs of Rescue Medication Over the 52 Week Period|Participants completed an electronic diary (eDiary) twice daily at the same time in the morning and evening to record the number of puffs of rescue medication taken in the previous 12 hours.|52 weeks|The Full Analysis set (FAS) included all randomized patients who received at least one dose of study medication. Participants, who had both baseline and week 52 values, were included in the analysis. Patients were analyzed according to the treatment to which they were randomized.||Number of puffs||Standard Error|Least Squares Mean
671646|NCT01682863|Secondary|Change From Baseline in Mean Total Daily Symptom Scores|The participant recorded symptom scores twice daily in the eDiary. The daily clinical symptoms included: cough, wheezing, shortness of breath, sputum volume, sputum color, and night time awakening. The range of scores for each assessment is 0 to 3 where 0 indications No symptom and 3 indicates a Severe symptom. The maximum daytime total score is 27 and the maximum nighttime total score is 27. The total daily symptom score is obtained by adding the scores for the morning and evening symptoms for each day. The maximum possible total daily score is 54. A negative change from baseline indicated improvement.|52 weeks|The Full Analysis set (FAS) included all randomized patients who received at least one dose of study medication. Participants, who had both baseline and week 52 values, were included in the analysis. Patients were analyzed according to the treatment to which they were randomized.||Score on a scale||Standard Error|Least Squares Mean
671647|NCT01682863|Secondary|Percentage of Participants Experiencing Moderate or Severe COPD Exacerbation|Percentage of participants experiencing moderate or severe Chronic Obstructive Pulmonary Disease (COPD)|52 weeks|The Full Analysis set (FAS) included all randomized patients who received at least one dose of study medication. Participants, who had both baseline and week 52 values, were included in the analysis.||Percentage of participants|||Number
672089|NCT01676896|Primary|Number of Asthma Hospitalizations Pre-Study Year|Number of times hospitalized for asthma. Data is obtained from parents for the pre-study year for the previous 12 months.|12 months before baseline|||number of hospitalizations||Standard Deviation|Mean
671648|NCT01682863|Secondary|Change From Baseline in FVC Measurement at All Post-baseline Time Points|Pulmonary function assessments were performed using centralized spirometry according to international standards.|Day1, 29, 57, 85, 141, 197, 253, 309, and 365|The Full Analysis set (FAS) included all randomized patients who received at least one dose of study medication. Participants, who had both baseline and week 52 values, were included in the analysis. Patients were analyzed according to the treatment to which they were randomized.||Liters||Standard Error|Least Squares Mean
671649|NCT01682863|Secondary|Change From Baseline in 1 Hour Post-dose FEV1 Measurements|Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction.|Day 1, 29, 57, 85, 141, 197, 253, 309, and 365|The Full Analysis set (FAS) included all randomized patients who received at least one dose of study medication. Participants, who had both baseline and week 52 values, were included in the analysis. Patients were analyzed according to the treatment to which they were randomized.||Liters||Standard Error|Least Squares Mean
671650|NCT01682863|Secondary|Change From Baseline in Pre-dose Trough FEV1|Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction.|Day 29, 57,, 85, 141, 197, 253, 309 and 365|The Full Analysis set (FAS) included all randomized patients who received at least one dose of study medication. Participants, who had both baseline and week 52 values, were included in the analysis. Patients were analyzed according to the treatment to which they were randomized.||Liters||Standard Error|Least Squares Mean
671651|NCT01682863|Secondary|Time to Premature Discontinuation of Treatment|methodTime to premature treatment discontinuation for each treatment group was displayed using a Kaplan-Meier curve. The date of last dose of study medication was considered as the event date and also as the censoring date for those patients who did not discontinue treatment earl|56 weeks|The Safety set consisted of all patients that received at least one dose of study medication and had at least one post-baseline safety assessment. Patients were analyzed according to treatment received.||Days||95% Confidence Interval|Median
671652|NCT01682863|Primary|Number of Patients With Adverse Events, Serious Adverse Events, and Death|The overall rate of adverse events reported from initiation through 30 days post last dose.|56 weeks|The Safety set:all patients that received at least one dose of study medication and had at least one post-baseline safety assessment. Patients were analyzed according to treatment received. The statement that a patient had no AEs also constituted a safety assessment. Only deaths occurring on treatment + 30 days after end of treatment were included.||Number of Patients|||Number
671653|NCT01682837|Secondary|Central Aortic Diastolic Blood Pressure||4 weeks|||mmHg||Standard Deviation|Mean
671654|NCT01682837|Secondary|Central Aortic Systolic Blood Pressure||4 weeks|||mmHg||Standard Deviation|Mean
671655|NCT01682837|Secondary|Carotid to Femoral Pulse Wave Velocity||4 weeks|||m/s||Standard Deviation|Mean
671656|NCT01682837|Secondary|24-hour Urinary Calcium||4 weeks of treatment|||mg/day||Standard Deviation|Mean
671657|NCT01682837|Secondary|Serum C-terminal Telopeptide (CTX)||4 weeks|||ng/ml||Standard Deviation|Mean
671658|NCT01682837|Secondary|Office Diastolic Blood Pressure||4 weeks|||mmHg||Standard Deviation|Mean
671659|NCT01682837|Secondary|Office Systolic Blood Pressure||4 weeks|||mmHg||Standard Deviation|Mean
671660|NCT01682837|Primary|24-hour Average Diastolic Blood Pressure|The average diastolic blood pressure over a 24 hour period.|4 weeks|||mmHg||Standard Deviation|Mean
671661|NCT01682837|Primary|24-hour Average Systolic Blood Pressure|This is the average systolic blood pressure over a 24 hour period.|4 weeks|All participants who completed the study completed all 4 phases.||mmHg||Standard Deviation|Mean
671662|NCT01682759|Secondary|Percentage of Participants Achieving a Hemoglobin A1C of <7.0% at Week 54|The percentage of participants who achieved A1C values <7.0% (53 mmol/mol) in the FAS Population at Week 54.|Week 54|The FAS Population (with multiple imputation) consisted of all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a measurement for the analysis endpoint after receiving study medication.||Percentage of participants||95% Confidence Interval|Number
671663|NCT01682759|Secondary|Change From Baseline in Body Weight at Week 54 Excluding Data After Gylcemic Rescue||Baseline and Week 54|The ASaT Population is defined as all randomized participants who received at least 1 dose of study medication. Participants were included in the treatment group corresponding to the study treatment they actually received.||kg||95% Confidence Interval|Least Squares Mean
671664|NCT01682759|Secondary|Percentage of Participants With an Adverse Event of Symptomatic Hypoglycemia Excluding Data After Glycemic Rescue|Symptomatic episode of hypoglycemia was an episode with clinical symptoms reported by the investigator as hypoglycemia (concurrent fingerstick glucose not required).|Up to Week 54|The ASaT Population is defined as all randomized participants who received at least 1 dose of study medication. Participants were included in the treatment group corresponding to the study treatment they actually received.||Percentage of participants|||Number
671665|NCT01682759|Secondary|Percentage of Participants Achieving a Hemoglobin A1C of <6.5% at Week 54|The percentage of participants who achieved A1C values <6.5% (48 mmol/mol) in the FAS Population at Week 54.|Week 54|The FAS Population (with multiple imputation) consisted of all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a measurement for the analysis endpoint after receiving study medication.||Percentage of participants||95% Confidence Interval|Number
671666|NCT01682759|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 54|Blood glucose was measured on a fasting basis. FPG is expressed as mg/dL. Blood was drawn at predose on Day 1 and after 54 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 54 minus FPG at baseline).|Baseline and Week 54|The FAS population consisted of all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a measurement for the analysis endpoint after receiving study medication.||mg/dL||95% Confidence Interval|Least Squares Mean
671667|NCT01682759|Primary|Percentage of Participants Who Discontinued From the Study Due to an Adverse Event Excluding Data After Glycemic Rescue||Up to Week 54|The ASaT Population is defined as all randomized participants who received at least 1 dose of study medication. Participants were included in the treatment group corresponding to the study treatment they actually received.||Percentage of participants|||Number
671668|NCT01682759|Primary|Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.|Up to Week 57|All Subjects as Treated (ASaT) population, defined as all randomized participants who received at least 1 dose of study medication. Participants were included in the treatment group corresponding to the study treatment they actually received.||Percentage of participants|||Number
671669|NCT01682759|Primary|Change From Baseline in Hemoglobin A1C at Week 54|Hemoglobin A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Thus, this change from baseline reflects the Week 54 A1C minus the Week 0 A1C.|Baseline and Week 54|The Full Analysis Set (FAS) population consisted of all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a measurement for the analysis endpoint after receiving study medication.||A1C (%)||95% Confidence Interval|Least Squares Mean
671670|NCT01682720|Secondary|Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse|"Viral breakthrough was defined as having confirmed detectable HCV RNA levels (HCV RNA > LLOQ) after having previously had undetectable HCV RNA levels (HCV RNA < LLOQ) while on treatment.
Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) at end of treatment, but did not achieve an SVR.
Data for this outcome measure was not collected for the Placebo 12 Weeks (GT2/3) group."|Up to Posttreatment Week 24|Full Analysis Set: participants with genotype 2 or 3 HCV infection were randomized and received at least 1 dose of SOF.||percentage of participants|||Number
671671|NCT01682720|Secondary|Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 was defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. Data for this outcome measure was not collected for the Placebo 12 Weeks (GT2/3) group.|Posttreatment Weeks 4 and 24|Full Analysis Set: participants with genotype 2 or 3 HCV infection were randomized and received at least 1 dose of SOF.||percentage of participants|||Number
671672|NCT01682720|Primary|Adverse Events Leading to Permanent Discontinuation of Study Drug(s)|The percentage of participants experiencing an adverse event leading to permanent discontinuation of study drug(s) was analyzed.|Up to 24 weeks|Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.||percentage of participants|||Number
671673|NCT01682720|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ, ie, < 25 IU/mL) 12 weeks following the last dose of study drug. Data for this outcome measure was not collected for the Placebo 12 Weeks (GT2/3) group.|Posttreatment Week 12|Full Analysis Set: participants with genotype 2 or 3 HCV infection were randomized and received at least 1 dose of SOF.||percentage of participants|||Number
671674|NCT01682681|Secondary|Percentage of Participants With Reduction in Seizure Frequency by 50 Percent or More|Percentage of participants for whom seizure frequency was reduced by greater than or equal to 50 percent after topiramate treatment were reported.|Week 52|FAS population included all participants who met all the eligibility criteria.||Percentage of participants||95% Confidence Interval|Number
671675|NCT01682681|Secondary|Percentage of Participants Without Seizure|Participants without seizure was calculated as percentage of participants who were found to be free of seizures and were observed up to Week 52.|Baseline up to Week 52|FAS population included all participants who met all the eligibility criteria.||Percentage of participants||95% Confidence Interval|Number
671676|NCT01682681|Secondary|Number of Participants Who Received Topiramate as First Mono-therapy, Second Mono-therapy or Add-on Therapy|Number of participants who received topiramate as first mono-therapy (initial treatment of epilepsy with a single drug), second mono-therapy (second line treatment with a single drug) or add-on therapy (as a supplement therapy to another drug) were reported.|Baseline up to Week 52|FAS population included all participants who met all the eligibility criteria.||Participants|||Number
671677|NCT01682681|Secondary|Number of Participants Who Received Concomitant Antiepileptic Drugs (AEDs)|Number of participants who received concomitant AEDs along with the topiramate were reported.|Baseline up to Week 52|FAS population included all participants who met all the eligibility criteria.||Participants|||Number
671678|NCT01682681|Primary|Percentage of Participants Retained to Topiramate Treatment|Participants with long term retention of topiramate until 52 weeks were reported|Week 52|The full analysis set (FAS) population included all participants who met all the eligibility criteria.||Percentage of participants||95% Confidence Interval|Number
671679|NCT01682642|Secondary|Total Follicle Stimulating Hormone (FSH) Dose|total dose of FSH needed at the end of stimulation|3 weeks|||IUs||Standard Deviation|Mean
671680|NCT01682642|Other Pre-specified|Number of Days of Stimulation|number of days needed before follicles in the ovary are mature for oocyte retrieval|3 weeks|||days||Standard Deviation|Mean
671681|NCT01682642|Secondary|Number of Cryopreserved Embryos|number of blastocytes that can be cryopreserved|1 week after oocyte retrieval|||number of cryopreserved embryos||Standard Deviation|Mean
671682|NCT01682642|Secondary|Number of Pro Nuclear Cell (2PN)|number of 2PN|1 day after oocyte retrieval|||number of pro nuclear cells||Standard Deviation|Mean
671683|NCT01682642|Secondary|Good Embryo Quality|The development of the embryo at the time of transfer on day 3. Good quality is defined by more than 7 cells and less then 20% fragmentation on day 3.|3 days after oocyte retrieval|||percentage of good quality embryos|||Number
671684|NCT01682642|Secondary|Pregnancy Rate|The number of ongoing pregnancies obtained which still is the most important issue for the patients.|12 weeks|||percentage of ongoing pregnancies|||Number
671685|NCT01682642|Primary|Number of Metaphase II Cells (MII)|number of MII cells retrieved|3 weeks|||MII cells||Standard Deviation|Mean
671686|NCT01682603|Other Pre-specified|Autonomic Dysreflexia||Baseline and 12 months|||participants|||Number
671687|NCT01682603|Primary|Net Change of the Quality of Life Index (QoL-I)|"Efficacy:
Net change of the quality of life index (QoL-I) from baseline and 12 months. The QoL-I on a 7-point scale ranging from 0 Delighted to 6 Terrible. The QoL-I ranges 0 to 6
Safety:
Systemic adverse events"|Baseline and 12 months|||units on a scale||Standard Deviation|Mean
671688|NCT01682603|Primary|Net Change of the Incontinence Impact Questionnaire (IIQ-7)|"Efficacy:
Net change of the Incontinence Impact Questionnaire (IIQ-7) from baseline and 12 months.
The IIQ-7 is a 7-item short forms on a 4-point scale ranging from 0 Not at all to 3 Greatly.
Total IIQ-7 score ranges = 0 to 21 The total IIQ-7 score can therefore range from 0 to 21 (asymptomatic to very symptomatic).
Safety:
Systemic adverse events"|Baseline and 12 months|||units on a scale||Standard Deviation|Mean
671689|NCT01682603|Secondary|Net Change of the Postvoid Residual Volume (PVR)|"Efficacy:
Net change of the postvoid residual volume (PVR) from baseline and 12 months
Results:
Botulinum toxin A injection have increased postvoid residual urine volume in patients treated for bladder dysfunction.
Treat only patients who are willing and able to initiate catheterization post-treatment, if required, for urinary retention.
Safety:
Systemic adverse events"|Baseline and 12 months|||mL||Standard Deviation|Mean
671690|NCT01682603|Secondary|Net Change of the Detrusor Pressure (Pdet)|"Efficacy:
Net change of the detrusor pressure (Pdet) from baseline and 12 months
Safety:
Systemic adverse events"|Baseline and 12 months|||cmH2O||Standard Deviation|Mean
671691|NCT01682603|Secondary|Net Change of the Void Volume|"Efficacy:
Net change of the void volume from baseline and 12 months
Safety:
Systemic adverse events"|Baseline and 12 months|||mL||Standard Deviation|Mean
671692|NCT01682603|Secondary|Net Change of the Maximum Flow Rate (Qmax)|"Efficacy:
Net change of the maximum flow rate (Qmax) from baseline and 12 months
Safety:
Systemic adverse events"|Baseline and 12 months|||mL/s||Standard Deviation|Mean
671693|NCT01682603|Secondary|Net Change of the Bladder Compliance|"Bladder compliance is the result of a mathematical calculation of the volume required for a unit rise of pressure measured during a cystometric filling.
Bladder compliance is calculated by dividing the volume change by the change in bladder pressure (mL/cmH2O).
Efficacy:
Net change of the bladder compliance from baseline and 12 months
Safety:
Systemic adverse events"|Baseline and 12 months|||mL/cmH2O||Standard Deviation|Mean
671694|NCT01682603|Secondary|Net Change of the Cystometric Bladder Capacity (CBC)|"Efficacy:
Net change of the cystometric bladder capacity (CBC) from baseline and 12 months
Safety:
Systemic adverse events"|Baseline and 12 months|||mL||Standard Deviation|Mean
671695|NCT01682603|Primary|Net Change of the Urinary Distress Inventory (UDI-6)|"Efficacy:
Net change of the UrinaryDdistress Inventory (UDI-6) from baseline and 12 months.
The UDI-6 is a 6-item short forms on a 4-point scale ranging from 0 Not at all to 3 Greatly.
The total UDI-6 score can therefore range from 0 to 18 (asymptomatic to very symptomatic).
Safety:
Systemic adverse events"|Baseline and 12 months|||units on a scale||Standard Deviation|Mean
671696|NCT01682538|Secondary|Apparent Volume of Distribution (Vz/F)|Measured for the Orfadin capsules and suspension treatments arms - both fasting and with food.|Day 1 predose and at 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose.|Per protocol set (bioequivalence) was used for fasting treatments and per protocol set (food effect) used for fed treatment (all subjects with available PK data)||L||Full Range|Median
671697|NCT01682538|Secondary|Oral Clearance (CL/F)|Measured for the Orfadin capsules and suspension treatments arms - both fasting and with food.|Day 1 predose and at 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose.|Per protocol set (bioequivalence) was used for fasting treatments and per protocol set (food effect) used for fed treatment (all subjects with available PK data)||L/h||Full Range|Median
671698|NCT01682538|Secondary|Terminal Half-life|Measured for the Orfadin capsules and suspension treatments arms - both fasting and with food.|Day 1 predose and at 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose.|Per protocol set (bioequivalence) was used for fasting treatments and per protocol set (food effect) used for fed treatment (all subjects with available PK data)||hours||Full Range|Median
671699|NCT01682538|Secondary|Time to Reach C-Max (t-Max)|Measured for the Orfadin capsules and suspension treatments arms - both fasting and with food.|Day 1 predose and at 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose.|Per protocol set (bioequivalence) was used for fasting treatments and per protocol set (food effect) used for fed treatment (all subjects with available PK data)||hours||Full Range|Median
671700|NCT01682538|Secondary|AUC From Time Zero to Infinity|Measured for the Orfadin capsules and suspension treatments arms - both fasting and with food.|Day 1 predose and at 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose.|Per-protocol set (bioequivalence) was used for fasted treatment groups and per-protocol set (food effect) for fed treatment group (all subjects with available PK data)||h*uM||Full Range|Geometric Mean
671701|NCT01682538|Secondary|The Maximum Serum Concentration (Cmax)|Measured for the Orfadin suspension treatment arms- both fasting and with food.|Day 1 predose and at 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose.|Full analysis set was used; subjects with available PK data for at least one of the treatments.||nM||Full Range|Geometric Mean
671702|NCT01682538|Secondary|The Area Under the Serum Concentration Curve (AUC) During 72 Hours After Dose (AUC72h)|Measured for the Orfadin suspension treatments arms- both fasting and with food.|Day 1 predose and at 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose.|Full analysis set was used; subjects with available PK data for at least one of the treatments.||uM*h||Full Range|Geometric Mean
671703|NCT01682538|Primary|The Maximum Serum Concentration (Cmax) During Fasting Conditions.||Day 1 predose and at 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose.|Full analysis set was used; subjects with available PK data for at least one of the treatments.||nM||Full Range|Geometric Mean
671704|NCT01682538|Primary|The Area Under the Serum Concentration Curve (AUC) During 72 Hours After Dose (AUC72h) During Fasting Conditions.||Day 1 predose and at 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose.|Full analysis set was used; subjects with available PK data for at least one of the treatments.||uM*h||Full Range|Geometric Mean
671705|NCT01682460|Other Pre-specified|Subjective Ratings of Comfort|Participants completed a standardized grading scale regarding their subjective ratings of comfort (0-100, 0=very poor comfort, 0 = excellent comfort)|1 month after using artificial tears|||units on a scale||Standard Deviation|Mean
671706|NCT01682460|Other Pre-specified|Subjective Ratings of Comfort|Participants completed a standardized grading scale regarding their subjective ratings of comfort (0-100, 0= very poor comfort, 100=excellent comfort)|1 week after using artificial tears|||units on a scale||Standard Deviation|Mean
671707|NCT01682460|Secondary|Ocular Surface Disease Index (OSDI) Score|"The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals none of the time and 4 equals all of the time. OSDI scores are calculated according to: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4]. The possible range of the OSDI score is 0 (best possible score) to 100 (worse possible score)."|1 month after using artificial tears|||units on a scale||Standard Deviation|Mean
671708|NCT01682460|Secondary|Ocular Surface Disease Index (OSDI) Score|"The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals none of the time and 4 equals all of the time. OSDI scores are calculated according to: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4]. The possible range of the OSDI score is 0 (best possible score) to 100 (worst possible score)."|1 week after using artificial tears|||units on a scale||Standard Deviation|Mean
671709|NCT01682460|Other Pre-specified|Subjective Ratings of Comfort|Participants completed a standardized grading scale regarding their subjective ratings of comfort (0 = very poor comfort, 100=excellent comfort)|At baseline (dispensing visit)|||units on a scale||Standard Deviation|Mean
671710|NCT01682460|Secondary|Ocular Surface Disease Index (OSDI) Score|"The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals none of the time and 4 equals all of the time. OSDI scores are calculated according to: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4]. The possible range of the OSDI score is 0 (best possible score) to 100 (worst possible score)."|At baseline (dispensing visit)|||units on a scale||Standard Deviation|Mean
671711|NCT01682460|Primary|Tear Break up Time With Fluorescein|The time taken for the tear film to break up on the surface of the cornea will be measured using slit lamp biomicroscopy following fluorescein instillation .|After 1 month|||seconds||Standard Deviation|Mean
671712|NCT01682460|Primary|Tear Break up Time With Fluorescein|The time taken for the tear film to break up on the surface of the cornea will be measured using slit lamp biomicroscopy following fluorescein instillation .|After 1 week|||seconds||Standard Deviation|Mean
671713|NCT01682460|Primary|Tear Break up Time With Fluorescein|The time taken for the tear film to break up on the surface of the cornea will be measured using slit lamp biomicroscopy following fluorescein instillation .|At baseline (dispensing visit)|||seconds||Standard Deviation|Mean
671714|NCT01682460|Primary|Ocular Surface Staining|Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= >30 dots + confluence|After 1 month|||units on a scale||Standard Deviation|Mean
671715|NCT01682460|Primary|Ocular Surface Staining|Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= >30 dots + confluence|After 1 week|||units on a scale||Standard Deviation|Mean
671716|NCT01682460|Primary|Ocular Surface Staining|Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= >30 dots + confluence|At baseline (dispensing visit)|||units on a scale||Standard Deviation|Mean
671717|NCT01682135|Secondary|Number of Participants With Best Objective Response (BOR)|Participants achieved disease control if they had a BOR of CR, PR or SD. Progressive Disease (PD) and those participants which were Not Evaluable (NE) were also reported. According to RECIST v1.1, CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels (if tumor markers were initially above the upper limit of normal); PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter. SD was neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started.|Baseline to Progressive Disease or Participant Stopped Study (Up to 10 Weeks)|All enrolled participants who received at least one dose of study drug.||Participants|||Number
671718|NCT01682135|Secondary|Number of Participants With Anti-Ramucirumab Antibodies|A sample will be considered positive for circulating anti-ramucirumab antibodies if it exhibits a post-baseline antibody level that exceeds the upper 95% confidence interval of the mean determined from the normal anti-ramucirumab level seen in healthy untreated individuals. A participant will be considered to have an anti-ramucirumab response if there are 2 consecutive positive samples or if the final sample tested is positive.|Cycle 1: Pre-infusion, Cycle 2: Pre-infusion, Cycle 3: Pre-infusion|All enrolled participants who received at least one dose of study drug and had evaluable immunogenicity data.||Participants|||Number
671719|NCT01682135|Secondary|Time to Disease Progression|Time to progressive disease was measured from the start of study drug until progressive disease. Censoring occurred if a participant did not have a complete baseline disease assessment, initiated on another anti-cancer therapy (censored at the date of the last complete objective progression-free disease assessment before initiation of the new therapy), was not known to have died or had objective progression as of the data inclusion cutoff date for analysis.|Baseline to Progressive Disease (Up to 10 Weeks)|All enrolled participants who received at least one dose of study drug. Censoring for Cohort 1, 2 and 3: 3, 2 and 2, respectively.||Months||95% Confidence Interval|Median
671720|NCT01682135|Secondary|Duration of Stable Disease (SD)|Duration of SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum of diameters while on study. SD is measured at the start of the study drug until progressive disease or death due to any cause, whichever is first. Censoring occurred if a participant did not have a complete baseline disease assessment, initiated on another anti-cancer therapy (censored at the date of the last complete objective progression-free disease assessment before initiation of the new therapy), was not known to have died or had objective progression as of the data inclusion cutoff date for analysis.|Baseline to Progressive Disease or Death Due to Any Cause (Up to 10 Weeks)|All enrolled participants who received at least one dose of study drug and had evaluable SD data. Participants censored for Cohort 1, 2, and 3: 3, 2, and 1, respectively.||Months||95% Confidence Interval|Median
671721|NCT01682135|Secondary|Duration of Response|Participants achieved an objective response if they had a best overall response of complete response (CR) or partial response (PR). According to RECIST v1.1, CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels (if tumor markers were initially above the upper limit of normal); PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter. For each participant who is not known to have died or to have had objective progression of disease as of the data-inclusion cut-off date for a particular analysis, duration of tumor response was to be censored at the date of the participant’s last objective tumor assessment prior to that cut-off date.|Time Between Meeting Response Criteria and Progressive Disease or Death Due to Any Cause (Up to 10 Weeks)|All enrolled participants who received at least one dose of study drug. There were no participants censored due to no CR or PR responses.||Months||95% Confidence Interval|Median
671722|NCT01682135|Primary|Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) of Ramucirumab|Cycle 1 analysis performed: Area Under the Concentration-Time Curve Zero to Infinity (AUC[0-∞]); Cycle 2 analysis performed: Area Under the Concentration-Time Curve Over the Dosing Interval at Steady State (AUC[τ,ss])|Cycle 1 & 2: Predose, End of Infusion, 0.5 hour (h) ,1h, 2h, 4h, 8h, 24h, 48h,72h or 96h, 168h, 264h, and 336h Postdose (and 504h Postdose Cohort 2 only)|All enrolled participants who received at least one dose of study drug and had evaluable AUC(0-∞) for Cycle 1 and AUC(τ,ss) for Cycle 2 PK data.||Microgram*day/milliliter (µg*day/mL)||Geometric Coefficient of Variation|Geometric Mean
671723|NCT01682135|Primary|Pharmacokinetics: Minimum Concentration (Cmin) of Ramucirumab||Cycle 2-5: Predose|All enrolled participants who received at least one dose of study drug and had evaluable Cmin PK data.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
671724|NCT01682135|Primary|Pharmacokinetics: Maximum Concentration (Cmax) of Ramucirumab||Cycle 1 & 2: Predose, End of Infusion, 0.5 hour (h) ,1h, 2h, 4h, 8h, 24h, 48h,72h or 96h, 168h, 264h, and 336h Postdose (and 504h Postdose Cohort 2 only)|All enrolled participants who received at least one dose of study drug and had evaluable Cmax pharmacokinetics (PK) data.||microgram/milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
671725|NCT01682135|Primary|Number of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious Adverse Events (SAEs)|A summary of AEs and SAEs considered by the investigator to be drug-related is located in the Reported Adverse Events module. An AE is summarized if the onset date is on or after the first dose of study drug and within 30 days after the last dose, or it occurred before the first dose of study drug and worsened while on the therapy.|Baseline through Study Completion (Up to 12 Weeks)|All enrolled participants who received at least one dose of study drug.||Participants|||Number
671733|NCT01682031|Secondary|Plasma Cisplatin and Selenium PK and PD Markers (NZ Only)|Descriptive statistics will be used to describe the mean plasma cisplatin and selenium at each time point. Repeated measures analysis of variance will be used to evaluate the changes in plasma cisplatin and selenium over time. Analysis of pharmacodynamic markers will be conducted using statistical methods appropriate for within-patient sequential analyses, such as repeated measures analysis of variance.|Up to 3 months post-treatment|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.|||||
671734|NCT01682031|Secondary|CRT Dose Delivery|This characteristic will be included in Cox models.|Up to 8 weeks|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.|||||
671735|NCT01682031|Secondary|Incidence of Grade 3 or 4 Treatment-related Toxicities, Including Xerostomia|Will be compared as difference in proportions with 95% confidence intervals.|Up to 5 years post-treatment|All treated and eligible patients||number of xerostomia events|||Number
671736|NCT01682031|Secondary|Quality of Life||Up to 1 year post-treatment|Due to the study's early termination and inadequate number of patients, no patients were analyzed.|||||
671737|NCT01682031|Secondary|Overall Survival|Estimated using the Kaplan-Meier method. Log-rank tests will be used for the comparison of survival distributions among study groups. Continuous endpoints will be summarized using means, standard deviations and percentiles.|Up to 5 years post-treatment|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.|||||
671738|NCT01682031|Secondary|Relapse-free Survival (RFS)|Assessed by Kaplan-Meier RFS curves and the proportion with an event at 1 year for RFS will be compared simultaneously to obtain more global sensitivity to differences in time-to-event.|At 1 year|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.|||||
671739|NCT01682031|Secondary|Tumor Complete Response Rate|Will be compared as difference in proportions with 95% confidence intervals. Disease will be measured according to the Response Evaluation Criteria in Solid Tumors (RECIST).|Up to 5 years post-treatment|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.|||||
671740|NCT01682031|Primary|Incidence of >= Grade 3 Mucositis|Will be compared as difference in proportions with 95% confidence intervals.|Up to 5 years|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.|||||
671741|NCT01681849|Secondary|Change in Brain Blood Flow Assessed by Statistical Parametric Mapping (SPM)|Participants were exposed to traumatic scripts versus neutral scripts before and after treatment with paroxetine or placebo. Brain blood flow was measured using statistical parametric mapping (SPM) which analyzes brain imaging data sequences. Statistical Parametric Mapping software is only capable of producing a single z-score for each Arm/Group. Data for each participant can not be generated using this software and therefore are not available to summarize in the data table below. Regional blood flow was compared for stress and neutral conditions and before and after treatment with paroxetine or placebo. Higher z-scores indicate an increase in regional blood flow to the medial prefrontal cortex under stress conditions for the 3 month time point relative to baseline. Statistical Parametric Mapping software is only capable of producing a single z-score for each Arm/Group.|Baseline, 3 Months Post Treatment|Statistical analyses yielded image data sets in which the values assigned to individual voxels correspond to the t-statistic of the difference in brain blood flow between conditions. Statistical images were displayed with values of z score units.||z-scores|||Number
671742|NCT01681849|Primary|Mean Clinical Administered PTSD Scale for DSM-IV (CAPS) Score|The CAPS is a 30-item questionnaire of PTSD symptomatology that provides continuous measures of symptom severity and frequency. CAPS-IV total symptom severity score is calculated by summing severity scores for the 17 DSM-IV PTSD symptoms. Each symptom is rated for severity based on frequency and intensity on a scale of 0-4 for a total possible severity score per symptom of 8. Criterion E (items 18-19) is duration of symptoms (minimum of one month to make the diagnosis). Items 20-30 are optional. CAPS score is based on items 1-17, CAPS score has a potential range of 0-136, with higher scores indicating greater severity of PTSD symptoms. CAPS was performed before and after treatment with paroxetine or placebo in PTSD patients.|Baseline, End of Study (Up to 52 Weeks)|Data for participants who completed all study visits were analyzed.||units on a scale||Standard Deviation|Mean
671743|NCT01681628|Post-Hoc|Assessment of Continuing Benefit of TFT After 19 Months, in Control Group, as Measured by a Diagnosis of PTSD According to a PCL-C Score of >50.|PCL-C (post traumatic check list for civilians) is a measure of the severity of post traumatic stress disorder (PTSD), and can also be used for screening populations, It is a self-completed questionnaire with 17 questions scoring from 1 - 5. The scores of each question are added to create the total score for each participant. The highest possible score for any individual is 85, the lowest score being 17. A diagnostic score for PTSD is accepted as being more than 50. Participants completed the PCL-C just before treatment and one week later. Only the wait-list control group was used as the treatment group did not not have a run-in score, and would have given inappropriately positive results.|Time 2 and 19 months later.|83% female average age 43 years, 17% male average age 46.7 years.||percentage of PCL-C scores >50.|||Number
671744|NCT01681628|Post-Hoc|Assessment of Any Persisting Benefit of TFT (Thought Field Therapy) After 19 Months.|PCL-C (post traumatic check list for civilians) is a measure of the severity of post traumatic stress disorder (PTSD), and can also be used for screening populations, It is a self-completed questionnaire with 17 questions scoring from 1 - 5. The scores of each question are added to create the total score for each participant. The highest possible score for any individual is 85, the lowest score being 17. A diagnostic score for PTSD is accepted as being more than 50. Participants completed the PCL-C one week following treatment and nineteen months later. Comparison of PCL-C scores at nineteen months compared to one week following treatment.|1 week post-treatment (Time 2, TFT; Time 3, WL) and 19 months later.|All those who had scores one week after treatment and at 19 months. Similar gender and age proportions to original groups.||units on a scale (PCL-C score)||Standard Deviation|Mean
671745|NCT01681628|Secondary|Percentage With Scores Diagnostic for Post Traumatic Stress Disorder (PCL-C > 50) Before and After Treatment in Treatment and Control Groups.|PCL-C (post traumatic check list for civilians) is a measure of the severity of post traumatic stress disorder (PTSD), and can also be used for screening populations, It is a self-completed questionnaire with 17 questions scoring from 1 - 5. The scores of each question are added to create the total score for each participant. The highest possible score for any individual is 85, the lowest score being 17. A diagnostic score for PTSD is accepted as being more than 50. Participants completed the PCL-C just before treatment and one week later. The wait list group received no treatment at Time 1.|Baseline (Time 1), One week later (Time 2) and Two weeks later (Time 3 for Wait-list: Thought field Therapy Arm)|Participants with symptoms suggestive of PTSD, thought field therapy group treated, wait list group not treated, and wait-list group treated. All assessed one week after initial assessment and treatment, and the percentage with a score > 50 compared before and after treatment, or control.||percentage with PCL-C score > 50|||Number
671746|NCT01681628|Primary|Change in Post-traumatic Stress Disorder Check List for Civilians (PLC-C) Score.|"PCL-C (post traumatic check list for civilians) is a measure of the severity of post traumatic stress disorder (PTSD), and can also be used for screening populations, It is a self-completed questionnaire with 17 questions scoring from 1 - 5. The scores of each question are added to create the total score for each participant. The highest possible score for any individual is 85, the lowest score being 17. A diagnostic score for PTSD is accepted as being more than 50. Participants completed the PCL-C just before treatment and one week later. The wait list group received no treatment at Time 1.
In the treatment arm, measure immediately pre-treatment (baseline) (time 1) and one week later (time 2).
In the wait-list no therapy arm, measure at baseline (time 1), and after one week (no treatment) (time 2). The wait-list group (Thought Field Therapy group) were then treated and reassessed after a further week (time 3)."|Baseline (Time 1), One week later (Time 2) and Two weeks later (Time 3 for Wait-list: Thought field Therapy Arm)|Participants with symptoms suggestive of PTSD, excluding non-attenders at Time 2. Non-attenders at time 3 were excluded from the wait-list (Thought Field Therapy) arm.||units on a scale||Standard Deviation|Mean
671747|NCT01681576|Secondary|Mean Sitting Pulse Pressure (PP) Over Time|Sitting mean pulse pressure rate was calculated between ambulatory SBP and DBP measurements|Day-1, Day 14 and Day 28|Pharmacodynamic PD analysis set: Patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data.||mmHg||Standard Deviation|Mean
671748|NCT01681576|Secondary|Seated Office Blood Pressure (BP) (Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)) Over Time|Seated Office BP (systolic blood pressure (SBP) and diastolic blood pressure (DBP))measurements will be performed at trough(immediately prior to dosing at the clinic). Arterial BP readings will be made with an automated BP device.|Day-1, Day 14 and Day 28|Pharmacodynamic PD analysis set: Patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data.||mmHg||Standard Deviation|Mean
671749|NCT01681576|Secondary|Urine Volume (Diuresis) Over Time|Urine will be collected and volume measured in fractions of 0 to 6 hours and 0 to 24 hours Day-1, Day 1 and Day 28|Day -1, Day 1 & Day 28|Pharmacodynamic PD analysis set: Patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data.||mL||Standard Deviation|Mean
671750|NCT01681576|Secondary|Cumulative Sodium Excretion (Natriuresis) at Day 28|Urine will be collected in fractions of 6 to 24 hours post-dose. From each fraction, a sample will be drawn for analysis of sodium Day 28|0-6 and 0-24 hours on Day 28|Pharmacodynamic PD analysis set: Patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data.||mmol||Standard Deviation|Mean
671751|NCT01681576|Primary|Cumulative Sodium Excretion (Natriuresis) at Day 1|Urine will be collected in fractions of 6 to 24 hours post-dose. From each fraction, a sample will be drawn for analysis of sodium Day 1|0-6 and 0-24 hours on Day 1|Pharmacodynamic PD analysis set: Patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data.||mmol||Standard Deviation|Mean
671752|NCT01681511|Other Pre-specified|Organism Relation to CAUTI and TIC|Organisms found in relation to CAUTI events in TIC versus control.|up to 30th day from the time of catheterization|||participants|||Number
671753|NCT01681511|Primary|The Proportion of Subjects With at Least One CAUTI|"CAUTI is as determined by blinded investigator assessment per protocol definition.
DAYS TO CAUTI = (DATE OF EVENT - DATE OF CZD INSERTION) + 1. Date of event for subjects who had CAUTI is the date of urine sample collection where the CAUTI criteria are met.
Date of event for subjects who did not have CAUTI is the last available urine culture collection date from samples collected during & post CZD.
p-values of time of CAUTI were obtained from log-rank test. p-values of Incidence of CAUTI were obtained from the Logistic Regression Model.
Evaluable population (EP) refers to all randomized subjects successfully CZD & stayed on the CZD for ≥ 48 ± 24 hours or more without any systemic (postoperative) antibiotic for CZD/non-CZD related reasons. Subjects receiving an intercurrent course of systemic antibiotics lasting >24 hours other than surgical prophylaxis were considered non-evaluable in all analyses of effectiveness endpoints using the EP.
CZD = Catheterized or catheter"|48 ± 24 hours or more|||participants|||Number
671754|NCT01681511|Secondary|The Proportion of Subjects With Asymptomatic Bacteremic Urinary Tract Infection (ABUTI)|Patients having an indwelling urinary catheter who have no signs or symptoms (i.e., no fever (>38°C), no urgency, frequency, dysuria, suprapubic tenderness, or costovertebral angle pain or tenderness), and a positive urine culture from urine collected from the catheter sampling port (or a midstream voided clean catch urine in subjects being followed for 48 hours post catheter removal) of >105 CFU/ml with no more than 2 species of uropathogen microorganisms and a positive blood culture with at least 1 matching uropathogen microorganism to the urine culture.|up to 30th day from the time of catheterization|||participants|||Number
671755|NCT01681511|Secondary|The Proportion of Subjects With Symptomatic Urinary Tract Infection (SUTI)|Patients with catheter related SUTI are those having an indwelling urinary catheter in place at the time of specimen collection, or had an indwelling catheter within the previous 48 hours, and at least 1 of the following signs or symptoms with no other recognized cause: fever (>38°C), suprapubic tenderness, or costovertebral angle pain or tenderness and a positive urinalysis demonstrated by at least one of the following findings: a. positive dipstick for leukocyte esterase and/or nitrite, b. pyuria (urine specimen collected from the catheter with ≥10 white blood cells [WBC]/mm3 or ≥3 WBC/high power field of unspun urine), c. microorganisms seen on Gram stain of unspun urine and a positive urine|up to 30th day from the time of catheterization|||Participants|||Number
671756|NCT01681511|Primary|Number of Subjects Affected, During Treatment and Follow-up Time Periods, by a Catheter Associated Urinary Tract Infection (CAUTI) Event After First CAUTI Event.|"All randomized subjects will be followed until (1) up to 30th day from the time of catheterization or (2) the subject withdraws or is discharged from the hospital, whichever comes first and (3) 48 hours after the catheter is removed.
Evaluable population (EP) refers to all randomized subjects successfully CZD & stayed on the CZD for ≥ 48 ± 24 hours or more without any systemic (postoperative) antibiotic for CZD/non-CZD related reasons. Subjects receiving an intercurrent course of systemic antibiotics lasting >24 hours other than surgical prophylaxis were considered non-evaluable in all analyses of effectiveness endpoints using the EP."|up to 30th day from the time of catheterization|||participants|||Number
671757|NCT01681472|Primary|Comparison of Folate Concentration in Tumor Tissue and Adjacent Mucosa Between Treatment Arms.||Sample taken Day 1 (Day of surgery).|Per protocol population, all patients who complete the trial without any major deviations from the protocol procedure.||pmol/g||Standard Deviation|Mean
671758|NCT01681368|Secondary|Total Clearance of Birinapant After Administration|Clearance is a quantitative measure of the rate at which a drug substance is removed from the body.|0-24hr|||L/hr||Full Range|Mean
671759|NCT01681368|Secondary|Coexpression of Cleaved Caspase 3 and Gamma-H2AX in Fixed Specimens|Tumor biopsies were measured for cleaved caspase 3 and gamma-H2A.X by immunofluorescence microscopy. Fold change was calculated by comparing the post-treatment measurements to the pre-treatment levels.|Pre treatment and post treatment of Birinapant, approximately 0-6 weeks|Only 2 pairs of adequate pre- and post-treatment biopsy samples were available for analysis. The remaining paired samples were inadequate for immunohistochemistry because of necrotic debris in the post-treatment biopsy sample (1 specimen) or contamination with blood (4 specimens).||Fold over baseline||Full Range|Median
672090|NCT01676896|Other Pre-specified|Lung Inflammation, Time 4|Exhaled breath condensation collected and sent for lab analysis of NO3. Data collected at Time 4 visit. Higher values represent greater airway inflammation.|Time 4 at 12 months|||uM||Standard Deviation|Mean
671760|NCT01681368|Secondary|Ratio of Phosphorylated NF-kappaB-p65 Protein to Total NF-kappaBp65 Protein in Tumor Biopsy Samples|Proteins were measured using capillary western blot and ratio was calculated between phosphorylated and total NF-kappaB p65. Core 1 tumor samples and peripheral blood mononuclear cells (PBMCs) from each time point were lysed in T-PER buffer (Thermo Scientific) for protein quantification by an automated capillary electrophoresis immunoassay system (Simple Western). The tumor protein lysate (40-60 ng) or PBMC protein lysate (16-77 ng) was analyzed according to the manufacturer’s instructions (ProteinSimple, Santa Clara, Calif).|0-6 weeks|4 patients refused second biopsy.||pixel intensity per ng protein||Full Range|Mean
671761|NCT01681368|Secondary|Calculated Volume of Distribution of Birinapant at Steady State (Vss) in Plasma|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.|0-24hr|||L||Standard Deviation|Mean
671762|NCT01681368|Secondary|Calculated Volume of Distribution of Birinapant at Steady State (Vss) in Tumor Tissue|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.|0-24hr|||L||Full Range|Mean
671763|NCT01681368|Secondary|Birinapant Concentration in Tumor Tissue|Levels of Birinapant were measured in core needle biopsies of tumor that had been frozen at the time of acquisition.|Prior to treatment and 12 to 22 hours following Cycle 2 Day 15|4 patients did not have the second paired biopsy due to patient refusal.||ng/g||Full Range|Mean
671764|NCT01681368|Secondary|Mean Plasma Concentration-Time Curve of Birinapant|Measurement of the plasma concentration of the Birinapant over time. It is used to characterize drug absorption. The single values were analyzed with liquid chromatography/tandem mass spectrometry via a proprietary methodology (TetraLogic Pharma,Malvern, Pa). The values were grouped and averaged for each of the patients to obtain the mean value for each time point.|30, 60, 120, 180 minutes after administration of first dose of Birinapant|||ng/mL||Standard Deviation|Mean
671765|NCT01681368|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|8 months|||participants|||Number
671766|NCT01681368|Primary|Objective Response (Complete Response (CR) or Partial Response (PR) Defined by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Criteria) or Disease Stabilization for Greater Than 6 Months|Per the RECIST criteria, CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10mm. Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.|6 months|||participants|||Number
671767|NCT01681277|Secondary|RA,AUC|Accumulation ratio of the analyte in plasma at steady state after multiple dose administration over a uniform dosing interval t, expressed as ratio of AUC at steady state and after single dose (RA,AUC).|-2h,0.25h,0.5h,0.75h,1h,1.5h,2h,2.5h,3h,4h,6h,8h,10h,12h,16h,23.917h and 311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h after single and multiple dose.|PKS||Ratio||Geometric Coefficient of Variation|Geometric Mean
671768|NCT01681277|Secondary|RA,Cmax|Accumulation ratio of the analyte in plasma at steady state after multiple oral administration over a uniform dosing interval t, expressed as ratio of Cmax at steady state and after single dose (RA,Cmax).|-2h,0.25h,0.5h,0.75h,1h,1.5h,2h,2.5h,3h,4h,6h,8h,10h,12h,16h,23.917h and 311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h after single and multiple dose.|PKS||Ratio||Geometric Coefficient of Variation|Geometric Mean
671769|NCT01681277|Secondary|t1/2,ss|Terminal half-life of the analyte in plasma at steady state (t1/2,ss).|311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h, 360h, 384h after last dose.|PKS||h||Geometric Coefficient of Variation|Geometric Mean
671770|NCT01681277|Secondary|AUCtau,ss|Area under the concentration-time curve of the analyte BI 113608 in plasma at steady state over a uniform dosing interval t (AUCtau,ss).|311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h after last dose. The time 324h for the b.i.d treatment and 336h for the q.d. treatment.|PKS||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
671771|NCT01681277|Secondary|Tmax,ss|Time from last dosing to maximum concentration of the analyte in plasma at steady state (tmax,ss).|311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h after last dose. The time 324h for the b.i.d treatment and 336h for the q.d. treatment.|PKS||h||Full Range|Median
671772|NCT01681277|Secondary|Cmax,ss|Maximum measured concentration of the analyte in plasma at steady state (Cmax,ss).|311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h after last dose. The time 324h for the b.i.d treatment and 336h for the q.d. treatment.|PK analysis set (PKS): This set included all subjects of the TS who provided at least one observation for at least one secondary PK endpoint without important protocol violations.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
671773|NCT01681277|Primary|Number of Participants With Clinically Relevant Abnormalities for Clinical Laboratory Evaluation, Vital Signs, and ECG Recordings|Number of participants with Clinically relevant abnormalities for clinical laboratory tests (haematology, clinical chemistry and urinalysis), vital signs (blood pressure (BP), pulse rate (PR), respiratory rate (RR), body temperature), and 12- lead electrocardiogram (ECG)|From administration of study drug until end-of-study, up to 17 days|Treated Set (TS)||participants|||Number
671774|NCT01681277|Primary|Percentage of Participants With Drug-related Adverse Events|Percentage of participants with drug-related adverse events|From administration of study drug until end-of-study, up to 17 days|Treated set||percentage of participants|||Number
671797|NCT01681095|Secondary|Myocardial Infarction|Number or participants fulfilling at least two of the following 3 criteria: (1) CK-MB of 100 ug/L or more and/or troponin-I of 3.0 ug/L or more, (2) appearance of new postoperative Q waves on the EKG of more than 0.03 seconds, and (3) a new hypokinetic or akinetic area in the left or right ventricle by echocardiography.|up to 36 hours post procedure|||participants|||Number
671798|NCT01681095|Secondary|Intensive Care Unit (ICU) Length of Stay|Duration of stay in ICU, from ICU admission to ICU discharge|up to 100 days after admission|||days||Inter-Quartile Range|Median
671775|NCT01681212|Secondary|Number of Patients Who Died and Who Had Serious Adverse Events (SAEs), Treatment-related SAEs, Adverse Events (AEs) Leading to Discontinuation, Related AEs Leading to Discontinuation, Related AEs, Grade 3-4 AEs, and Related Grade 3-4 AEs|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or unknown relationship to study drug. Grade 1=mild; Grade 2=moderate; Grade 3=severe; Grade 4=life-threatening or disabling; Grade 5=death.|First dose to 90 days following last dose of study drug. All deaths were poststudy, occurring more than 90 days after the last dose of study drug.|All participants who received at least 1 dose of study drug||Participants|||Number
671776|NCT01681212|Secondary|Number of Participants With Grade 3-4 Immune-related Adverse Events (irAEs)|irAEs are adverse events of unknown cause, consistent with an immune phenomenon, and considered to be causally related to drug exposure. Six subcategories of irAE are assessed: gastrointestinal, liver, skin, endocrine, neurologic, and other. The irAEs are programmatically determined from a predefined list of MedDRA terms. irAEs will be measured every 3 weeks in induction phase, every 6 weeks in Maintenance Phase to Week 48, and every 12 weeks until Progressive Disease. Grading criteria: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death.|First dose to 90 days following last dose of study drug|All participants who received at least 1 dose of study drug||Participants|||Number
671777|NCT01681212|Primary|Percentage of Participants Surviving at 1 Year|Survival rate=percentage of participants surviving at 1 year following start of study drug. Every effort was made to collect survival data on all patients, including those withdrawn from treatment for any reason. If the death of a patient was not reported, the patient's last known alive date was recorded. Confidence intervals were computed using the Clopper-Pearson method.|At 1 year from start of study drug|All participants who received at least 1 dose of study drug.||Percentage of participants||90% Confidence Interval|Number
671778|NCT01681121|Other Pre-specified|Evaluate the Change From Baseline in the Median Number of Cataplectic Attacks Per Week for the Subset of Subjects With Cataplexy for ADX-N05 vs. Placebo at Last Assessment||12 weeks||||||
671779|NCT01681121|Other Pre-specified|Evaluate the Change From Baseline in the Median Number of Cataplectic Attacks Per Week for the Subset of Subjects With Cataplexy for ADX-N05 vs. Placebo at Week 4||4 weeks||||||
671780|NCT01681121|Secondary|Evaluate the Safety and Tolerability of ADX-N05 vs Placebo in Adults With Narcolepsy by Assessing Treatment Emergent Adverse Events, Vital Signs, Laboratory Results, ECGs, and Physical Exams.||12 weeks||||||
671781|NCT01681121|Secondary|Evaluate the Patient Global Impression-Change Scores for ADX-N05 vs. Placebo at Last Assessment||12 weeks||||||
671782|NCT01681121|Secondary|Evaluate the Patient Global Impression-Change Scores for ADX-N05 vs. Placebo at Week 4||4 weeks||||||
671783|NCT01681121|Secondary|Evaluate the Clinical Global Impression-Change Scores for ADX-N05 vs. Placebo at Week 4||4 weeks||||||
671784|NCT01681121|Secondary|Evaluate the Change From Baseline in Sleep Latency Time (in Minutes) as Determined From Each of the 5 Individual Maintenance of Wakefulness Test Trials for ADX-N05 vs. Placebo at Last Assessment||12 weeks||||||
671785|NCT01681121|Secondary|Evaluate the Change From Baseline in Sleep Latency Time (in Minutes) as Determined From Each of the 5 Individual Maintenance of Wakefulness Test Trials for ADX-N05 vs. Placebo at Week 4||4 weeks||||||
671786|NCT01681121|Secondary|Evaluate the Change From Baseline in the Average Sleep Latency Time (in Minutes) as Determined From the Maintenance of Wakefulness Test (Average of the First Four Trials) Following Four Weeks of Treatment With ADX-N05 150 mg vs. Placebo||4 weeks||||||
671787|NCT01681121|Secondary|Evaluate the Change From Baseline in Epworth Sleepiness Scale Scores for ADX-N05 vs. Placebo at Last Assessment||12 weeks||||||
671788|NCT01681121|Secondary|Evaluate the Change From Baseline in Epworth Sleepiness Scale Scores for ADX-N05 vs. Placebo at Week 4||4 weeks||||||
671789|NCT01681121|Primary|Evaluate the Clinical Global Impression-Change Scores for ADX-N05 vs. Placebo at Last Assessment||12 weeks||||||
671790|NCT01681121|Primary|Change From Baseline in the Average Sleep Latency Time (in Minutes) as Determined From the Maintenance of Wakefulness Test for ADX-N05 vs. Placebo at Last Assessment.|Sleep Latency - The primary analysis was a comparison of treatments vs. control groups on change from Baseline to last available post-Baseline assessment (Week 12/Last Assessment) in the average sleep latency time (in minutes) averaged across the first four trials of the MWT using a two-sample t-test.|Baseline and 12 weeks|93 subject were randomly assigned to a treatment group; 90 subjects (43 on ADX-N05 and 47 on Placebo) had at least one post-Basdeline efficacy assessment (Intent-to-treat [ITT] Population). For the primary endpoint analysis (40 on ADX-N05 and 45 on Placebo) have assessment week 12/last assessment||Minutes||Standard Deviation|Mean
671791|NCT01681095|Secondary|Cardiac Marker - Troponin-I|Troponin-I measured 48 hours post-operative|48 hours post procedure|Only patients for whom 48-hour Troponin-I values were available were included in analysis||ng/mL||Standard Deviation|Mean
671792|NCT01681095|Secondary|Cardiac Marker - Troponin-I|Troponin-I measured 24 hours post-operative|24 hours post procedure|Only patients for whom 24-hour Troponin-I values were available were included in analysis||ng/mL||Standard Deviation|Mean
671793|NCT01681095|Secondary|Cardiac Marker - Troponin-I|Troponin-I measured pre-operatively|pre-operatively|Only patients for whom preoperative Troponin-I values were available were included in analysis||ng/mL||Standard Deviation|Mean
671794|NCT01681095|Secondary|Biochemical Marker - Creatine Kinase MB Isoenzyme (CK-MB)|CK-MB measured 48 hours post-operatively|48 hours post procedure|Only patients for whom 48 hour CK-MB values are available are included in analysis||ng/mL||Standard Deviation|Mean
671795|NCT01681095|Secondary|Biochemical Marker - Creatine Kinase MB Isoenzyme (CK-MB)|CK-MB measured 24 hours post-operatively|24 hours post procedure|Only patients for whom 24 hour CK-MB values were available were analyzed||ng/mL||Standard Deviation|Mean
671796|NCT01681095|Secondary|Biochemical Marker - Creatine Kinase MB Isoenzyme (CK-MB)|CK-MB measured pre-operatively|pre-operative|Only patients for whom preoperative CK-MB levels were available were analyzed||ng/mL||Standard Deviation|Mean
672112|NCT01676532|Secondary|Number of Students Attending SBHC With New Treatment Plans|Proportion of children seen in the clinic with treatment plans|1 year|115 students out of 127 students attending SBHC had a new treatment plan.||participants|||Number
671799|NCT01681095|Secondary|Postoperative Inotropic Infusion >20 Minutes|Number of patients receiving vasopressor or inotropic infusion for greater than 20 minutes in the operating room, including norepinephrine, epinephrine, vasopressin, milrinone, dobutamine, dopamine and/or neo-synephrine.|during operative procedure|||participants|||Number
671800|NCT01681095|Secondary|Duration of Vasopressor / Inotropic Agent|Total time in minutes on any vasopressor or inotropic agent, including norepinephrine, epinephrine, vasopressin, milrinone, dobutamine, dopamine and/or neo-synephrine|up to 36 hours post procedure|Patients not receiving any vasopressors are excluded from this analysis||minutes||Inter-Quartile Range|Median
671801|NCT01681095|Secondary|Time on Mechanically Assisted Ventilation|time in hours from intubation to extubation, with intervening transport to the cardiac critical care unit.|up to 36 hours post procedure|||hours||Inter-Quartile Range|Median
671802|NCT01681095|Secondary|Cardiovascular Mortality|Number of participants with cardiovascular-related mortality AS reported in the Society of Thoracic Surgeons (STS) database after 30 days postoperative|30 days post procedure|||participants|||Number
671803|NCT01681095|Secondary|All Cause Mortality|Number of participants with all-cause mortality AS reported in the Society of Thoracic Surgeons (STS) database after 30 days postoperative|30 days post procedure|||participants|||Number
671804|NCT01681095|Secondary|Cardiac Dysrhythmias|Number of participants with new or worsening of cardiac dysrhythmias|up to 36 hrs post surgery|||participants|||Number
671805|NCT01681095|Primary|Changes in Left Ventricular (LV) Ejection Fraction (EF) by Transthoracic Echocardiogram (TTE)|LV ejection fraction by TTE, difference from baseline at 24 hours post surgery|Baseline and 24 hours post surgery|patients for whom both preoperative and 24 hour LV ejection fractions were obtained||% LV volume||Standard Deviation|Mean
671806|NCT01681095|Primary|Change in Troponin I|Troponin I values, difference from baseline 7 hours post surgery|Baseline and 7 hours post surgery|||ng/mL||Inter-Quartile Range|Median
671807|NCT01681095|Primary|Change in Creatine Phosphokinase-MB Isoenzyme (CK-MB)|Creatine phosphokinase MB isoenzyme (CK-MB) difference from baseline 7 hours post surgery|Baseline and 7 hours post surgery|Patients for which both baseline and 7 hours post surgery values were available||ng/mL||Inter-Quartile Range|Median
671808|NCT01681069|Secondary|Change in Mean Body Fat at End of Study From Baseline|Measured in kg using calibrated weighing scales|12 weeks|||kg||Standard Deviation|Mean
671809|NCT01681069|Secondary|Change in Waist Circumference (in cm) at End of Study From Baseline|Difference in waist circumference (in cm) at end of study from baseline|12 weeks|||cm||Standard Deviation|Mean
671810|NCT01681069|Primary|Change in Body Weight at End of Study Compared to Baseline|Change in body weight at the end of study compared to baseline|12 weeks|||kg||Standard Deviation|Mean
671811|NCT01681004|Secondary|Number of Participants With Serious Adverse Events (SAEs)|Any event meeting ISO 14155 definition for serious adverse event at following time points: during procedure (if randomized to iFuse), hospital discharge (if iFuse, typically 1-2 days), and 1, 3, 6, 12, 18 and 24 months after randomization.|Procedure, discharge, 1, 3, 6, 12, 18 and 24 months|All treated study subjects.||Participants|||Count of Participants
671812|NCT01681004|Secondary|Work Status|"Non-working subjects who return to work
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol."|24 Months|Patients not working at baseline due to back or other pain||Participants|||Count of Participants
671813|NCT01681004|Secondary|Work Status|"Non-working subjects who return to work
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol."|18 Months|Patients not working at baseline due to back or other pain||Participants|||Count of Participants
671814|NCT01681004|Secondary|Work Status|"Non-working subjects who return to work
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol."|12 Months|Patients not working at baseline due to back or other pain||Participants|||Count of Participants
671815|NCT01681004|Secondary|Work Status|"Non-working subjects who return to work
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol."|6 Months|Patients not working at baseline due to back or other pain||Participants|||Count of Participants
671816|NCT01681004|Secondary|Work Status|"Non-working subjects (due to back pain or other reasons) who return to work
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol."|3 Months|Patients not working at baseline due to back or other pain||Participants|||Count of Participants
671817|NCT01681004|Secondary|Work Status|"Proportion of non-working (due to back pain or other reasons) subjects who return to work
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol."|1 month|Patients not working at baseline due to back or other pain. Note this is a subset of the entire population.||Participants|||Count of Participants
671818|NCT01681004|Secondary|Ambulatory Status|"Time to full ambulation among those without full ambulation at baseline.
60 days was the median of time to full ambulation for the iFuse implant System arm."|24 months (surgical group), 6 months (non-surgical group)|Number of days to full ambulation among those without full ambulation at baseline. At baseline only 13 in the surgical arm were not Ambulatory without assistance and for the NSM group, it was only 5 at baseline.||Days, median||95% Confidence Interval|Median
671819|NCT01681004|Secondary|Improvement in Quality of Life (QOL) as Measured by EQ-5D (EuroQol-5D) at Post-operative Visits|"Improvement in quality of life (QOL) as measured by EQ-5D (EuroQol-5D) at post-operative visits. EQ-5D is a five-question broad quality of life measure that can be combined into a single index and represents the time trade-off (TTO) utility of current health. A score of 0 would = worst imaginable health, while a score of 1.0 would be best imaginable health.
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol."|24 months|13 iFuse subjects did not complete the 24-month assessment. Analysis was not done for the NSM group at 24 months due to the high crossover rate.||units on a scale||Standard Deviation|Mean
671914|NCT01680328|Secondary|Acceptance of Injection Pain After Injection in the Thighs Versus Abdomen.|Acceptance of pain was rated subjectively as yes or no by the subject after each injection.|1 minute (±30 seconds) after each injection|All randomised subjects receiving at least one injection (possibly needle insertion only) were included in the full analysis set.||scores|||Number
671820|NCT01681004|Secondary|Improvement in Quality of Life (QOL) as Measured by EQ-5D (EuroQol-5D) at Post-operative Visits|"Improvement in quality of life (QOL) as measured by EQ-5D (EuroQol-5D) at post-operative visits. EQ-5D is a five-question broad quality of life measure that can be combined into a single index and represents the time trade-off (TTO) utility of current health. A score of 0 would = worst imaginable health, while a score of 1.0 would be best imaginable health.
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol."|12 Months|2 iFuse subjects did not complete the survey at month 12. Due to high crossover rate to surgery, analysis in the NSM group is not valid.||units on a scale||Standard Deviation|Mean
671821|NCT01681004|Secondary|Improvement in Quality of Life (QOL) as Measured by EQ-5D (EuroQol-5D) at Post-operative Visits|"Improvement in quality of life (QOL) as measured by EQ-5D (EuroQol-5D) at post-operative visits. EQ-5D is a five-question broad quality of life measure that can be combined into a single index and represents the time trade-off (TTO) utility of current health. A score of 0 would = worst imaginable health, while a score of 1.0 would be best imaginable health.
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol."|6 months|Results show improvement in score from baseline.||units on a scale||Standard Deviation|Mean
671822|NCT01681004|Secondary|Improvement in Quality of Life (QOL) as Measured by SF-36 PCS (Physical Component) at Post-operative Visits|"Improvement in quality of life (QOL) as measured by SF-36 PCS (Physical Component) at post-operative / NSM visits. The Short Form 36 health survey (SF-36) is a 36-item patient reported health questionnaire to measure quality of life across 8 domains. The PCS is the Physical Component Summary score. PCS is normed, so that normal scores are 50 +- 10. Higher scores indicate higher quality of life; lower scores indicate lower quality of life. SF-36 PCS (NBS, 2009 norms) ranges from 5 (minimum value, poor physical function) to 80 (maximum, excellent clinical function).
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol."|24 months|Change in QOL score at 24 months. 89 participants had QOL information at 24 months. Analysis of the NSM cohort is not done because high crossover to surgery prevents valid analysis.||units on a scale||Standard Deviation|Mean
671823|NCT01681004|Secondary|Improvement in Quality of Life (QOL) as Measured by SF-36 PCS (Physical Component) at Post-operative Visits|"Improvement in quality of life (QOL) as measured by SF-36 PCS (Physical Component) at post-operative / NSM visits. The Short Form 36 health survey (SF-36) is a 36-item patient reported health questionnaire to measure quality of life across 8 domains. The PCS is the Physical Component Summary score. PCS is normed, so that normal scores are 50 +- 10. Higher scores indicate higher quality of life; lower scores indicate lower quality of life. SF-36 PCS (NBS, 2009 norms) ranges from 5 (minimum value, poor physical function) to 80 (maximum, excellent clinical function).
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol."|12 Months|A total of 2 iFuse subjects had exited the study before making it to their 12 month visit. This outcome is not evaluated in the NSM group at month 12 because high crossover to surgical treatment prevents valid analysis.||units on a scale||Standard Deviation|Mean
671824|NCT01681004|Secondary|Improvement in Quality of Life (QOL) as Measured by SF-36 PCS (Physical Component) at Post-operative Visits|"Improvement in quality of life (QOL) as measured by SF-36 PCS (Physical Component) at post-operative / NSM visits. The Short Form 36 health survey (SF-36) is a 36-item patient reported health questionnaire to measure quality of life across 8 domains. The PCS is the Physical Component Summary score. PCS is normed, so that normal scores are 50 +- 10. Higher scores indicate higher quality of life; lower scores indicate lower quality of life. SF-36 PCS (NBS, 2009 norms) ranges from 5 (minimum value, poor physical function) to 80 (maximum, excellent clinical function).
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol."|6 months|2 iFuse and 2 NSM subjects did not complete SF-36 at month 6.||units on a scale||Standard Deviation|Mean
671825|NCT01681004|Secondary|Improvement in Back Dysfunction|Improvement in ODI score of greater than or equal to 15 points compared to baseline. Oswestry Disability Index is a validated measure of disability related to low back pain. Subjects in the NSM group who crossed over are considered failures for this endpoint by definition.|24 Months|The Count of participants = number of subjects that had a threshold change in ODI score of greater than or equal to 15 points. Overall number of participants = number of subjects analyzed. Of the 102, a total of 13 iFuse Implant subjects exited the study and 1 did not complete the ODI survey. By 6 months, 39 NSM subjects crossed over to surgical.||Participants|||Count of Participants
671826|NCT01681004|Secondary|Improvement in Back Dysfunction|Improvement in ODI score of greater than or equal to 15 points compared to baseline. Oswestry Disability Index is a validated measure of disability related to low back pain. Subjects in the NSM group who crossed over are considered failures for this endpoint by definition.|12 Months|2 iFuse subjects did not complete ODI at month 12. ODI analysis is not valid in NSM group at 12 months because of high crossover.||Participants|||Count of Participants
671827|NCT01681004|Secondary|Improvement in Back Dysfunction|"Improvement in ODI score of greater than or equal to 15 points, at post-operative visits. 6 month visit.
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol."|6 Months|1 iFuse and 2 NSM subjects did not complete ODI at month 6.||Participants|||Count of Participants
671828|NCT01681004|Secondary|Improvement in Back Dysfunction|"Improvement in ODI score of greater than or equal to 15 points, at month 3.
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol."|3 Months|2 iFuse subjects and 3 NSM subjects did not complete ODI at month 3.||Participants|||Count of Participants
671829|NCT01681004|Secondary|Improvement in Back Dysfunction|"Improvement in ODI score of greater than or equal to 15 points, at month 1.
Oswestry Disability Index is a validated measure of disability related to low back pain. There are 10 sections, each with a score between 0-5. Scores are expressed on a percent basis without using the percent term. Scores range from 0 (no disability) to 100 (completely disabled).
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol."|1 month|2 iFuse and 1 NSM subjects did not complete ODI at 1 month||Participants|||Count of Participants
671974|NCT01678846|Secondary|Child Mental Health|score on the Strengths and Difficulties Questionnaire (SDQ): 20 questions. Total difficulties score, divided by the number of completed items. Modelled as a continuous variable. Range 0 (no difficulties) to 2 (high difficulties).|2-year follow-up|||units on a scale||Standard Deviation|Mean
671830|NCT01681004|Secondary|Improvement in SI Joint Pain VAS Score at 24 Months|Improvement in SI joint pain VAS score of greater than or equal to 20 points compared to baseline. The Visual Analog Scale (VAS) is a 100 mm line on which the subject indicates their level of pain. 0 = no pain. 100 = worst imaginable pain. Note that secondary endpoint analysis is based on available data only. Subjects in the NSM group who crossed over are considered failures for this endpoint by definition.|24 Months|12 iFuse subjects did not complete the 24-month pain score. Analysis of 24-month scores in the NSM group is not valid because of the high crossover rate.||Participants|||Count of Participants
671831|NCT01681004|Secondary|Improvement in SI Joint Pain VAS Score at 12 Months|Improvement in SI joint pain VAS score of greater than or equal to 20 points compared to baseline. The Visual Analog Scale (VAS) is a 100 mm line on which the subject indicates their level of pain. 0 = no pain. 100 = worst imaginable pain. Note that secondary endpoint analysis is based on available data only. Subjects in the NSM group who crossed over are considered failures for this endpoint by definition.|12 Months|2 iFuse subjects did not complete the 12-month pain score. Analysis of 12-month scores in the NSM group is not valid because of the high crossover rate.||Participants|||Count of Participants
671832|NCT01681004|Secondary|Improvement in SI Joint Pain VAS Score at 6 Months|Improvement in SI joint pain VAS score of greater than or equal to 20 points, at post-operative & NSM visits after 6 months. The Visual Analog Scale (VAS) is a 100 mm line on which the subject indicates their level of pain. 0 = no pain. 100 = worst imaginable pain. Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.|6 Months|1 iFuse and 3 NSM subjects did not complete the 6-month pain score.||Participants|||Count of Participants
671833|NCT01681004|Secondary|Improvement in Si Joint Pain VAS Score at 3 Months|Improvement in SI joint pain VAS score of greater than or equal to 20 points, at post-operative & NSM visits after 3 months. The Visual Analog Scale (VAS) is a 100 mm line on which the subject indicates their level of pain. 0 = no pain. 100 = worst imaginable pain. Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.|3 Months|2 iFuse and 3 NSM subjects did not complete the 3-month pain score.||Participants|||Count of Participants
671834|NCT01681004|Secondary|Improvement in SI Joint Pain VAS Score at 1 Month|Improvement in SI joint pain VAS score of greater than or equal to 20 points, at post-operative & NSM visit after 1 month. The Visual Analog Scale (VAS) is a 100 mm line on which the subject indicates their level of pain. 0 = no pain. 100 = worst imaginable pain. Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.|1 month|2 iFuse and 1 NSM subjects did not complete the pain score.||Participants|||Count of Participants
671835|NCT01681004|Primary|Subject Success|Composite endpoint of reduction from baseline in VAS back pain score by at least 20 mm, lack of device-related serious adverse events, absence of neurologic worsening and absence of surgical re-intervention. Note that the primary endpoint analysis is **intent to treat**, meaning that an outcome (success or failure) is assigned to all subjects randomized and treated. Subjects who withdrew early were deemed study failures.|6 months|A modified intent-to-treat approach was used.||Participants|||Count of Participants
671836|NCT01680991|Secondary|Time to Recovery of CD19+ B-cell|Recovery is defined as CD19+ B-cell equal to or greater than 0.07 x 10^9/L. Time to recovery is defined as time between the beginning of depletion and first value after end of treatment that is equal or above 0.07x10^9/L and not exclusively followed by depleted values only. If participant did not return to above recovery level then set to Null.|Screening, Cycle 1 (Days 1,8), Cycle 2 (Day 1), Cycle 4 (Day 1), Cycle 6 (Day 1), Cycle 8 (Day 1), 4 weeks after last dose of study drug and every 3 months after last dose of study drug up to 1 year|"Safety analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome and n represents the number of participants evaluable for the specified category."||days||Standard Deviation|Mean
671837|NCT01680991|Secondary|Duration of Depletion of CD19+ B-cell|Depletion is defined as CD19+ B-cell count < 0.07 x 10^9/L. The duration of depletion is defined as the number of days between first assessment of B-cell depletion and the first assessment where CD19+ cell count returned to at least the depletion level from baseline and not followed by any further B-cell depletion. If participant did not return to above depletion level, then the cut off is at the time of last assessment.|Screening, Cycle 1 (Days 1,8), Cycle 2 (Day 1), Cycle 4 (Day 1), Cycle 6 (Day 1), Cycle 8 (Day 1), 4 weeks after last dose of study drug and every 3 months after last dose of study drug up to 1 year|Safety analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.||days||Standard Deviation|Mean
671838|NCT01680991|Secondary|Number of Participants With B-cell Depletion or Recovery|Depletion is defined as cluster of differentiation (CD) 19+ B-cell count <0.07 x10^9/L.Recovery is defined as CD19+ B-cell equal to or greater than 0.07 x 10^9/L.|Screening, Cycle 1 (Days 1,8), Cycle 2 (Day 1), Cycle 4 (Day 1), Cycle 6 (Day 1), Cycle 8 (Day 1), 4 weeks after last dose of study drug and every 3 months after last dose of study drug up to 1 year|Safety analysis population.||participants|||Number
671839|NCT01680991|Secondary|Number of Participants With Positive Human Anti-Chimeric Antibodies (HACA)|Serum concentrations of HACA against rituximab were determined by ELISA. The LLOQ in undiluted serum was 5.00 relative units per milliliter (RU/mL). The precision and accuracy of the assay, as determined from the analysis of quality control samples, were satisfactory throughout the study; precision ranged from 6.4% to 13.6% and accuracy ranged from 88.2% to 94.8%.|Cycle 1, Day 1|Safety analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.||participants|||Number
671840|NCT01680991|Secondary|Number of Participants With Positive Human Anti-Human Antibodies (HAHA)|For the detection of HAHA, serum samples were initially analyzed using a validated enzyme linked immunosorbent assay (ELISA) method (screening assay, tier 1). The lower limit of quantification (LLOQ) in undiluted serum was 18.4 nanograms per milliliter (ng/mL). The precision ranged from 4.85 percent (%) to 16.0%. In serum samples found positive, the presence of specific anti-obinutuzumab antibodies was confirmed or excluded using the same ELISA method with an appropriate immunocompetition step (addition of excess obinutuzumab, confirmation assay, tier 2). Samples were confirmed as containing specific anti-obinutuzumab antibodies if there was a signal reduction ≥85.7% in the presence of obinutuzumab.|Cycle 1 (Day 1), Cycle 4 (Day 1), 4-week follow-up, 3 and 6 month follow-up|"Safety analysis population. n represents the number of participants who were evaluable at the specified time point."||participants|||Number
671975|NCT01678846|Primary|Physical Violence From School Staff|past week experience of any physical violence from school staff|2-year follow-up|||participants|||Number
671841|NCT01680991|Secondary|Percentage of Participants With BOR of PR, SD, and PD at Anytime During Study in CLL Participants According to IWCLL 2008 Guidelines|Group A: a)Dec LN size by ≥50% either in SPD of 6 LN or largest diameter of ELN detected BT, b)Red in BT enlargement of liver, c)Red in BT enlargement of spleen, d)Dec in PBL by ≥50% from baseline, e)A 50% Red in BM infiltrate or B-lymphoid nodules in BM and f)No Inc in any LN and no new ELN. Group B: a)Plt count=100,000/µL or Inc of ≥50% over baseline, b)Hb >11 g/dL or ≥50% Inc over baseline, c)Neu > 1500/µL or > 50% Inc over baseline. PR is considered as achieved if 2 of Group A criteria and 1 of Group B criteria were met for ≥2 months. PD is defined as LD (appearance of new lesion [ELN], SM, HM or other organ infiltrates) or Inc by ≥50% in greatest determined diameter of any previous site or Inc in previously noted enlargement of liver/spleen by ≥50% or new appearance of HM/SM or an Inc in number of PBL ≥50% or transformation to a more aggressive histology or occurrence of cytopenia attributable to CLL. SD is defined as less than a PR but is not PD.|From screening to up to 2 months after the last dose (received on Day 148) of study drug|Safety analysis population. Data reported only for CLL participants.||percentage of participants||95% Confidence Interval|Number
671842|NCT01680991|Secondary|Percentage of Participants With BOR of CRe, CRi at Anytime During the Study in CLL Participants According to IWCLL 2008 Guidelines|CRe required the following criteria as assessed, at least 2 months from completing therapy: a) PBL <4 x 10^9/L, b) Absence of significant LD by PE, c) No HM/SM by PE, d) Absence of constitutional symptoms and e) Blood counts above the following values (i. Neu >1.5 x 10^9/L without the need for EGF, ii. Plt >100 x 10^9/L without the need for EGF, and iii. Hb >11.0 g/dL without blood transfusion or need for EGF, and d) Once clinical and laboratory reports demonstrated CRe, a BM aspirate and biopsy was performed at least 2 months after the last treatment; to define a CRe, BM sample should be normocellular for age, <30% of the cells being PBL and lymphoid nodules absent. CRi: CRe but persistent anemia/thrombocytopenia/neutropenia unrelated to CLL, but related to drug toxicity.|From screening to up to 2 months after the last dose (received on Day 148) of study drug|Safety analysis population. Data reported only for CLL participants.||percentage of participants||95% Confidence Interval|Number
671843|NCT01680991|Secondary|Percentage of Participants With PR, SD, and PD at End of Treatment (1 Month After Cycle 8) in CLL Participants According to IWCLL 2008 Guidelines|Group A: a)Dec LN size by ≥50% either in SPD of 6 LN or largest diameter of enlarged LN (ELN) detected BT, b)Reduction (Red) in BT enlargement of liver, c)Red in BT enlargement of spleen, d)Dec in PBL by ≥50% from baseline, e)A 50% Red in BM infiltrate or B-lymphoid nodules in BM and f)No Inc in any LN and no new ELN. Group B: a)Plt count=100,000/µL or Inc of ≥50% over baseline, b)Hb >11 g/dL or ≥50% Inc over baseline, c)Neu > 1500/µL or > 50% Inc over baseline. PR is considered as achieved if 2 of Group A criteria and 1 of Group B criteria were met for ≥2 months. PD is defined as LD (appearance of new lesion [ELN], SM, HM or other organ infiltrates) or Inc by ≥50% in greatest determined diameter of any previous site or Inc in previously noted enlargement of liver/spleen by ≥50% or new appearance of HM/SM or an Inc in number of PBL ≥50% or transformation to a more aggressive histology or occurrence of cytopenia attributable to CLL. SD is defined as less than a PR but is not PD.|2 months after the last dose (received on Day 148) of study drug|Safety analysis population. Data reported only for CLL participants||percentage of participants||95% Confidence Interval|Number
671844|NCT01680991|Secondary|Percentage of Participants With Complete Remission (CRe), CRe With Incomplete BM Recovery (CRi) at End of Treatment (1 Month After Cycle 8) in CLL Participants According to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 Guidelines|CRe required the following criteria as assessed, at least 2 months from completing therapy: a) peripheral blood lymphocytes (PBL) less than (<) 4 x 10^9/L, b) Absence of significant lymphadenopathy (LD) by physical examination (PE), c) No hepatomegaly/splenomegaly (HM/SM) by PE, d) Absence of constitutional symptoms and e) Blood counts above the following values (i. Neutrophils [Neu] >1.5 x 10^9/L without the need for exogenous growth factors [EGF], ii. Platelets (Plt) >100 x 10^9/L without the need for EGF, and iii. Hemoglobin (Hb) >11.0 g/dL without blood transfusion or need for erythropoietin), and d) Once clinical and laboratory reports demonstrated CRe, a BM aspirate and biopsy was performed at least 2 months after the last treatment; to define a CRe, BM sample should be normocellular for age, <30% of the cells being PBL and lymphoid nodules absent. CRi: CRe but persistent anemia/thrombocytopenia/neutropenia unrelated to CLL, but related to drug toxicity.|2 months after the last dose (received on Day 148) of study drug|Safety analysis population. Data reported only for CLL participants.||percentage of participants||95% Confidence Interval|Number
671845|NCT01680991|Secondary|Percentage of Participants With BOR of PR, SD, and PD at Anytime During Study in NHL Participants (DLBCL and FL Participants) Per Cheson 1999 Criteria|PR: 1) ≥50% decrease in SPD of the 6 largest dominant nodes/nodal masses. These nodes or masses selected according to the following features: a) clearly measurable in ≥2 perpendicular dimensions, b) from as disparate regions of the body as possible, and c) included mediastinal and retroperitoneal areas of disease. 2) No increase in size of other nodes (liver/spleen). 3) Splenic and hepatic nodules regressed by ≥50% in SPD. 4) With exception of splenic and hepatic nodules, involvement of other organs was considered assessable and not measurable disease. 5) BM assessment is irrelevant for determination of a PR because it was assessable and not measurable disease; however, if positive, the cell type was specified. 6) No new sites of disease. PD requires the following: 1) ≥50% increase from nadir in the SPD of any previously identified abnormal node for PRs or nonresponders. 2) Appearance of any new lesion during or at the end of therapy. SD is defined as less than a PR but not PD.|From screening to up to 1 month after the last dose (received on Day 148) of study drug|Safety analysis population. Data reported only for DLBCL and FL arm groups.||percentage of participants||95% Confidence Interval|Number
671856|NCT01680991|Primary|Maximum Observed Serum Concentration (Cmax) of Obinutuzumab on Day 1, Cycle 1|DLBCL and FL are sub-types of NHL and time frame for these 2 groups was presented under NHL. For CLL, PK parameters were from Cycle 1 Day 1 and Day 2 dosing, due to split dosing.|Cycle 1-NHL: within 2 h Pr-D, EoI, 4, 24, 72 and 120 h Po-I on Day 1; CLL: within 2 h Pr-D, EoI on Days 1,2; 4, 24, 72 and 120 h Po-I on Day 2. NHL and CLL: within 2 h Pr-D on Day 8|PK analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.||micrograms per milliliter (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
671915|NCT01680328|Secondary|Acceptance of Injection Pain After Injection at Different Speeds.|Acceptance of pain was rated subjectively as yes or no by the subject after each injection.|1 minute (±30 sec) after each injection|All randomised subjects receiving at least one injection (possibly needle insertion only) were included in the full analysis set.||scores|||Number
671846|NCT01680991|Secondary|Percentage of Participants With Best Overall Response (BOR) of CR, CRu at Anytime During Study in NHL Participants (DLBCL and FL Participants) Per Cheson 1999 Criteria|CR: 1) Disappearance of clinical and radiographic evidence of disease, related symptoms and normalization of biochemical abnormalities definitely assignable to NHL, 2) LN and nodal masses regressed to normal size AT (≤1.5 cm] in their GTD for LN >1.5 cm BT). LN that were 1.1 to 1.5 cm in their GTD BT decreased to ≤1 cm in GTD AT, or >75% in the SPD of the GTD, 3) Enlarged spleen regressed in size and not palpable, 4) Absence of macroscopic nodules in any organs, 5) Enlarged organs decreased in size, and 6) If the BM was involved, the infiltrate must be cleared on repeat BM aspirate and biopsy. CRu included those participants who met CR Criteria 1 and 3, but with 1 or more of the following features: a) A residual LN mass >1.5 cm in GTD that has regressed by more than 75% in their SPD, b) Indeterminate BM (increased number or size of aggregates).|From screening to up to 1 month after the last dose (received on Day 148) of study drug|Safety analysis population. Data reported only for DLBCL and FL arm groups.||percentage of participants||95% Confidence Interval|Number
671847|NCT01680991|Secondary|Percentage of Participants With Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD) at End of Treatment (1 Month After Cycle 8) in NHL Participants (DLBCL and FL Participants) Per Cheson 1999 Criteria|PR: 1) ≥50% decrease in SPD of the 6 largest dominant nodes/nodal masses. These nodes or masses selected according to the following features: a) clearly measurable in ≥2 perpendicular dimensions, b) from as disparate regions of the body as possible, and c) included mediastinal and retroperitoneal areas of disease. 2) No increase in size of other nodes (liver/spleen). 3) Splenic and hepatic nodules regressed by ≥50% in SPD. 4) With exception of splenic and hepatic nodules, involvement of other organs was considered assessable and not measurable disease. 5) BM assessment is irrelevant for determination of a PR because it was assessable and not measurable disease; however, if positive, the cell type was specified. 6) No new sites of disease. PD requires the following: 1) ≥50% increase from nadir in the SPD of any previously identified abnormal node for PRs or nonresponders. 2) Appearance of any new lesion during or at the end of therapy. SD is defined as less than a PR but not PD.|1 month after the last dose (received on Day 148) of study drug|Safety analysis population. Data reported only for DLBCL and FL arm groups.||percentage of participants||95% Confidence Interval|Number
671848|NCT01680991|Secondary|Percentage of Participants With Complete Response (CR), CR Unconfirmed (CRu) at End of Treatment (1 Month After Cycle 8) in NHL Participants (DLBCL and FL Participants) Per Cheson 1999 Criteria|CR: 1) Disappearance of clinical and radiographic evidence of disease, related symptoms and normalization of biochemical abnormalities definitely assignable to NHL, 2) Lymph nodes (LN) and nodal masses regressed to normal size after therapy (AT) (≤1.5 centimeters [cm] in their greatest transverse diameter [GTD] for LN greater than (>) 1.5 cm before therapy [BT]). LN that were 1.1 to 1.5 cm in their GTD BT decreased to ≤1 cm in GTD AT, or >75% in the sum of the products (SPD) of the GTD, 3) Enlarged spleen regressed in size and not palpable, 4) Absence of macroscopic nodules, 5) Enlarged organs decreased in size, and 6) If the bone marrow (BM) was involved, the infiltrate must be cleared on repeat BM aspirate and biopsy. CRu included those participants who met CR Criteria 1 and 3, but with 1 or more of the following features: a) A residual LN mass >1.5 cm in GTD that has regressed by more than 75% in their SPD, and b) Indeterminate BM (increased [Inc] number or size of aggregates).|1 month after the last dose (received on Day 148) of study drug|Safety analysis population. Data reported only for DLBCL and FL arm groups.||percentage of participants||95% Confidence Interval|Number
671849|NCT01680991|Secondary|Minimum Observed Serum Concentration of Obinutuzumab||Within 2 hours Pr-D on Day 1 of Cycles 2-8 and on Days 8,15 of Cycle 1|"PK population. Here, number of participants analyzed = participants who were evaluable for this outcome and n is the number of participants evaluable at the specified time point."||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
671850|NCT01680991|Secondary|Total Systemic Clearance at Steady State (CLss) of Obinutuzumab at Cycle 8|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.|Cycle 8: within 2 h Pr-D, EoI, 4, 24, 72, 120, 168, 336 (Day 15), and 504 (Day 22) h Po-I on Day 1|PK analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.||mL/day||Geometric Coefficient of Variation|Geometric Mean
671851|NCT01680991|Secondary|Volume of Distribution at Steady State (Vss) of Obinutuzumab at Cycle 8|Vss reflects the actual blood and tissue volume into which a drug is distributed and the relative binding of drug to protein in these spaces.|Cycle 8: within 2 h Pr-D, EoI, 4, 24, 72, 120, 168, 336 (Day 15), and 504 (Day 22) h Po-I on Day 1|PK analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.||Liter||Geometric Coefficient of Variation|Geometric Mean
671852|NCT01680991|Secondary|Apparent Terminal Half-life (t1/2)|Half-life is the time measured for the serum concentration of study drug to decrease (Dec) by one half.|Cycle 8: within 2 h Pr-D, EoI, 4, 24, 72, 120, 168, 336 (Day 15), and 504 (Day 22) h Po-I on Day 1, 4-week follow-up (Day 29), 3 and 6 months after Cycle 8 dosing|PK analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.||day||Geometric Coefficient of Variation|Geometric Mean
671853|NCT01680991|Secondary|Time to Maximum Observed Serum Concentration (Tmax) of Obinutuzumab at Cycle 8||Cycle 8: within 2 h Pr-D, EoI, 4, 24, 72, 120, 168, 336 (Day 15), and 504 (Day 22) h Po-I on Day 1|PK analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Median
671854|NCT01680991|Primary|Cmax of Obinutuzumab at Cycle 8||Cycle 8: within 2 h Pr-D, EoI, 4, 24, 72, 120, 168, 336 (Day 15), and 504 (Day 22) h Po-I on Day 1|PK analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
671855|NCT01680991|Primary|Area Under the Serum Concentration Versus Time Curve From 0 to Day 21 (AUC0-21) of Obinutuzumab at Cycle 8||Cycle 8: within 2 h Pr-D, EoI, 4, 24, 72, 120, 168, 336 (Day 15), and 504 (Day 22) h Po-I on Day 1|PK analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.||day*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
671883|NCT01680666|Secondary|Number of Complications||April 2008-September 2011||||||
671884|NCT01680666|Secondary|Number of Arterial Punctures||April 2008-September 2011||||||
671885|NCT01680666|Secondary|Total Number of Venous Cannulation Attempts||April 2008-September 2011||||||
671857|NCT01680991|Primary|Area Under the Serum Concentration Time Curve From Zero to Day 7 (AUC0-7) of Obinutuzumab on Day 1, Cycle 1|DLBCL and FL are sub-types of Non-Hodgkin's Lymphoma (NHL) and time frame for these 2 groups was presented under NHL. For CLL, pharmacokinetic (PK) parameters were from Cycle 1 Day 1 and Day 2 dosing, due to split dosing.|Cycle 1-NHL: within 2 hours (h) pre-dose (Pr-D), end of infusion (EoI), 4, 24, 72 and 120 h post-infusion (Po-I) on Day 1; CLL: within 2 h Pr-D, EoI on Days 1,2; 4, 24, 72 and 120 h Po-I on Day 2. NHL and CLL: within 2 h Pr-D on Day 8|PK analysis population included all participants who received at least 1 dose of study drug and had serum concentrations available. Here, number of participants analyzed = participants who were evaluable for this outcome.||day*micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
671858|NCT01680900|Primary|Daily Diary Ratings of Severity of Hot Flashes|Hot flash severity will be recorded daily in the am and pm on a scale of 0 (none) to 3 (severe). The frequency of hot flashes was the number reported. The severity of hot flashes was rated on a scale of 0 (none) to 3 (severe). 7-day averages were calculated for baseline, week 4 and week 8 and a mean daily score was obtained for analysis. Baseline values were the means of the first 2 screen weeks. Possible range of the severity scale for the daily mean was 0 (none) to 3 (severe).|Week 8.|all participants randomized to treatment||units on a scale||95% Confidence Interval|Mean
671859|NCT01680900|Other Pre-specified|Sheehan Global Ratings of Symptom (Hot Flash)Interference|Global ratings on a 10-point scale of the degree that symptoms interfere overall, with work, social activities and family life.|Change from Baseline at Week 8||||||
671860|NCT01680900|Other Pre-specified|Percentage of Participants That Were Satisfied or Very Satisfied|Patient global rating of satisfaction with medication reported on a scale of 0 to 5 (very satisfied).|Week 8|all participants with at least one treatment response.||percentage of participants|||Number
671861|NCT01680900|Other Pre-specified|Number of Participants With Adverse Events|A 17 item checklist of general adverse and withdrawal symptoms. It will be used at baseline and Week 12. Adverse events will be obtained by subject report at Week 4 and Week 8.|Baseline and Week 12|||participants|||Number
671862|NCT01680900|Secondary|Menopause-related Quality of Life (MENQOL)|The MENQOL is a validated measure to assess the presence and bother of menopausal symptoms. This will be exploratory. Each of 29 items is rated on a scale of 0 to 6 (extremely bothersome). The items are divided into 4 subscales. The item scores are summed in each subscale and means are computed for the 4 subscales. The total score is the sum of the mean subscale scores. Higher scores are more symptomatic.|Week 8|||units on a scale||95% Confidence Interval|Mean
671863|NCT01680900|Secondary|Percent of Patients With >=50% Reduction in Moderate to Severe Hot Flashes|Percent of patients with n >=50% reduction in frequency of moderate to severe hot flashes calculated from daily diaries|Percent change from baseline at Week 8|all participants with at least one treatment response||percentage of participants|||Number
671864|NCT01680900|Primary|Daily Diary Ratings of Frequency of Hot Flashes|Hot flash frequency and severity will be recorded daily in the am and pm on a scale of 0 (none) to 3 (severe). The frequency of hot flashes was the number reported.|Week 8.|all participants randomized to treatment||number of hot flashes||95% Confidence Interval|Mean
671865|NCT01680861|Secondary|Discontinuance of Any Study Medication (Tacrolimus, Everolimus, or EC-MPS)||during the first 12 months post-transplant|Note: one patient in the Tacrolimus/EC-MPS arm discontinued EC-MPS at 12 months post-transplant following a colon cancer diagnosis and the necessity to receive chemotherapy.||participants|||Number
671866|NCT01680861|Secondary|eGFR (Renal Function) at 6 Months Post-transplant|using the abbreviated MDRD formula.|at 6 months post-transplant|||ml/min per 1.73 m2||Standard Error|Mean
671867|NCT01680861|Secondary|eGFR (Renal Function) at Month 3 Post-transplant|Renal function as determined by the estimated glomerular filtration rate (eGFR) at 3 months post-transplant, using the abbreviated MDRD formula.|at 3 months post-transplant|||ml/min per 1.73 m^2||Standard Error|Mean
671868|NCT01680861|Secondary|eGFR (Calculated Glomerular Filtration Rate), i.e., Renal Function, at 1 Month Post-transplant.|using the abbreviated MDRD formula.|at 1 month post-transplant|||ml/min per 1.73 m2||Standard Error|Mean
671869|NCT01680861|Secondary|Graft Loss (Return to Permanent Dialysis or Death)||during the first 12 months post-transplant|||participants|||Number
671870|NCT01680861|Secondary|Incidence of Chronic Allograft Nephropathy (CAI) at 12 Months Post-transplant|Incidence of (biopsy-proven) chronic allograft nephropathy (CAI) [interstitial fibrosis and tubular atrophy, using standard Banff criteria] at 12 months post-transplant.|1 year|||participants|||Number
671871|NCT01680861|Primary|BPAR (Biopsy-proven Acute Rejection) Incidence During the First 12 Months Post-transplant|BPAR (biopsy-proven acute rejection) incidence during the first 12 months post-transplant. Grading is determined using standard Banff criteria.|1 year|||participants|||Number
671872|NCT01680848|Primary|Percentage of Participants Who Indicate Surgical Intervention||Up to 24 months|||percentage of the dentists|||Number
671891|NCT01680497|Secondary|Subject Assessments of Pain, Swelling, and Bruising Intensity on an 11-Point Scale|Subject assessment of pain, swelling and bruising intensity on an 11-point scale. Scores range from 0 (No pain/swelling/bruising) to 10 (worst pain/swelling/bruising imaginable).|Day 0, Day 14, Month 12, Month 12.5|Efficacy Population: all subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point||Scores on a Scale||Standard Deviation|Mean
671892|NCT01680497|Secondary|Subject Satisfaction With Aesthetic Outcome on an 11-Point Scale|Subject satisfaction with aesthetic outcome is assessed on an 11-point scale. Scores range from -5 (definitely not satisfied), 0 (don't know/unsure), and 5 (definitely satisfied).|Day 14, Month 1, Month 9, Month 12|Efficacy Population: all subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point||Scores on a Scale||Standard Deviation|Mean
671893|NCT01680497|Secondary|Subject Assessment of Nasolabial Fold Severity Using the 5-point NLFSS|Nasolabial fold severity is evaluated by the subject on the 5-point NLFSS on both the right and left sides. Scores are assessed as 1 (none), 2 (mild), 3 (moderate), 4 (severe), and 5 (extreme).|Day 0, Day 14, Month 1, Month 9, Month 12|Efficacy Population: all subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point||Scores on a Scale||Standard Deviation|Mean
671894|NCT01680497|Secondary|Investigator Assessment of Ease of Injection Use on a 10-Point Scale|Investigator assessment of ease of injection use is assessed on a 10-point scale. Scores range from 0 (easy) to 10 (hard).|Day 0, Day 14|Efficacy Population: all subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point||Scores on a Scale||Standard Deviation|Mean
671895|NCT01680497|Secondary|Investigator Satisfaction With Aesthetic Outcome on an 11-Point Scale|Investigator satisfaction with aesthetic outcome is assessed on an 11-point scale. Scores range from -5 (definitely not satisfied), 0 (don't know/unsure), and 5 (definitely satisfied).|Day 14, Month 1, Month 9, Month 12|Efficacy Population: all subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point||Scores on a Scale||Standard Deviation|Mean
671896|NCT01680497|Secondary|Investigator Assessment of Nasolabial Fold Severity Using the 5-point NLFSS|Nasolabial fold severity is evaluated by the Investigator on the 5-point NLFSS on both the right and left sides. Scores are assessed as 1 (none), 2 (mild), 3 (moderate), 4 (severe), and 5 (extreme).|Day 0, Day 14, Month 1, Month 9|Efficacy Population: all subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point||Scores on a Scale||Standard Deviation|Mean
671897|NCT01680497|Primary|Investigator Assessment of Nasolabial Fold Severity Using the 5-point Nasolabial Fold Severity Scale (NLFSS)|Nasolabial fold severity is evaluated by the Investigator on the 5-point NLFSS on both the right and left sides. Scores are assessed as 1 (none), 2 (mild), 3 (moderate), 4 (severe), and 5 (extreme).|Month 12|Efficacy Population: all subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point||Scores on a Scale||Standard Deviation|Mean
671898|NCT01680458|Primary|Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert|A treatment-related adverse event was any untoward medical occurrence attributed to fluconazole in a participant who received fluconazole. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to fluconazole was assessed by the investigator and sponsor (Pfizer Japan Inc.).|MAX 13 Weeks|SAS comprised of participants who had met the inclusion criteria and had received fluconazole at least once.||Participants|||Number
671899|NCT01680458|Primary|Number of Participants With Treatment-Related Serious Adverse Events|A treatment-related adverse event was any untoward medical occurrence attributed to fluconazole in a participant who received fluconazole. A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to fluconazole was assessed by the investigator and sponsor (Pfizer Japan Inc.).|MAX 13 Weeks|SAS comprised of participants who had met the inclusion criteria and had received fluconazole at least once.||Participants|||Number
671900|NCT01680458|Primary|Number of Participants With Treatment-Related Adverse Events|A treatment-related adverse event was any untoward medical occurrence attributed to fluconazole in a participant who received fluconazole. Relatedness to fluconazole was assessed by the investigator and sponsor (Pfizer Japan Inc.).|MAX 13 Weeks|SAS comprised of participants who had met the inclusion criteria and had received fluconazole at least once.||Participants|||Number
671901|NCT01680458|Secondary|Onset Rate of Deep Mycosis|Efficacy of deep mycosis prophylaxis was evaluated by the presence or absence of deep mycosis onset during the observation period. Onset rate of deep mycosis was calculated as follows and presented along with the corresponding exact 2-sided 95% CI. Onset rate of deep mycosis (%) = (Number of participants with deep mycosis onset by target fungi) / (Number of participants available for prophylactic efficacy evaluation) x 100.|MAX 13 Weeks|Efficacy analysis set for prophylaxis comprised of participants in SAS who had started to receive fluconazole for the prophylaxis and had been evaluated for the presence or absence of deep mycosis onset.||Percentage of participants||95% Confidence Interval|Number
671916|NCT01680328|Secondary|Acceptance of Injection Pain After Injection of Different Volumes.|Acceptance of pain was rated subjectively as yes or no by the subject after each injection.|1 minute (±30 seconds) after each injection|All randomised subjects receiving at least one injection (possibly needle insertion only) were included in the full analysis set.||scores|||Number
671929|NCT01680016|Primary|Number of Older Adults Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur|Safety was assessed as the number of subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after any vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.|Days 1 to 7 postvaccination|Analysis was done on the safety set||Subjects|||Number
672158|NCT01675453|Secondary|Inflammation Response|Serum levels of Interleukin 6 (IL-6) and Interleukin 10 (IL-10) will be used to assess this outcome measure.|24 hours||||||
671902|NCT01680458|Secondary|Fungi Eradication Rate|Mycological effect of treatment was evaluated as follows: (1) eradicated; the causative fungi detected from the lesion before treatment became undetectable, (2) presumably eradicated; the lesion was improved and sampling of causative fungi became impossible, (3) decreased; the causative fungi were decreased, (4) unchanged; no change was observed in the causative fungi, (5) increased; the causative fungi were increased (including microbial substitution), and (6) indeterminate; the clinical follow-up was inadequate, causative fungi were undetectable, or mycological test was not performed. Fungi eradication rate was calculated as follows. Fungi eradication rate (%) = (Number of participants evaluated as “eradicated” or “presumably eradicated”) / (Number of participants available for mycological efficacy evaluation) x 100|MAX 13 Weeks|Mycological analysis set for treatment comprised of participants in SAS with the final diagnosis of deep mycosis, who had started to receive fluconazole for the treatment and had been evaluated for the mycological effect.||Percentage of participants|||Number
671903|NCT01680458|Secondary|Clinical Efficacy Rate|Clinical effect of treatment was evaluated based on the clinical course excluding mycological effect as follows: (1) effective, (2) ineffective, or (3) unevaluable. Clinical efficacy rate was calculated as follows and presented along with the corresponding exact 2-sided 95% CI. Clinical efficacy rate (%) = (Number of responders in evaluation of clinical effect) / (Number of participants available for clinical efficacy evaluation) x 100.|MAX 13 Weeks|Efficacy analysis set for treatment comprised of participants in safety analysis set (SAS) who had started to receive fluconazole for the treatment and had been evaluated for the clinical effect.||Percentage of participants||95% Confidence Interval|Number
671904|NCT01680341|Secondary|Number of Treatment Emergent Nocturnal (00:01-05:59) Confirmed Hypoglycaemic Episodes|Confirmed hypoglycaemic episodes consisted of episodes of severe hypoglycaemia and minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 am.|Weeks 0-27|The safety analysis set included all subjects who received at least one dose of the investigational product.||episodes|||Number
671905|NCT01680341|Secondary|Number of Treatment Emergent Confirmed Hypoglycaemic Episodes in the Maintenance Period|Confirmed hypoglycaemic episodes in the maintenance period (from Week 16 to the end of the trial including follow-up [Week 27]) consisted of episodes of severe hypoglycaemia and minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|From week 16 to end of trial including follow-up (week 27)|The safety analysis set included all subjects who received at least one dose of the investigational product. Subjects in maintenance period were included in this analysis.||episodes|||Number
671906|NCT01680341|Secondary|Number of Treatment Emergent Confirmed Hypoglycaemic Episodes|Confirmed hypoglycaemic episodes consisted of episodes of severe hypoglycaemia and minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Weeks 0-27|The safety analysis set included all subjects who received at least one dose of the investigational product.||episodes|||Number
671907|NCT01680341|Secondary|Incidence of Treatment Emergent Adverse Events (TEAEs)|A Treatment Emergent Adverse Event (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment.|Weeks 0-28|The safety analysis set included all subjects who received at least one dose of the investigational product.||number of events|||Number
671908|NCT01680341|Secondary|Percentage of Subjects With HbA1c Below 7.0% Without Confirmed Hypoglycaemia|Percentage of subjects with HbA1c below 7% without confirmed hypoglycaemic episodes after 26 weeks of treatment.|Week 26|The full analysis set (FAS) included all randomised subjects. Missing data were imputed using LOCF. Twenty five (25) subjects did not contribute to statistical analysis as Endpoint was only defined for subjects exposed for at least 12 treatment weeks.||percentage of subjects|||Number
671909|NCT01680341|Secondary|Subjects With HbA1c Below 7.0%|Number of subjects with HbA1c below 7% after 26 weeks of treatment.|Week 26|The full analysis set (FAS) included all randomised subjects. Missing data were imputed using LOCF.||Subjects|||Number
671910|NCT01680341|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|Change from baseline in fasting plasma glucose (FPG) after 26 weeks of treatment|Week 0, Week 26|The full analysis set (FAS) included all randomised subjects. Missing data were imputed using LOCF.||mmol/L||Standard Error|Least Squares Mean
671911|NCT01680341|Primary|Change From Baseline in HbA1c (Glycosylated Haemoglobin) (%)|Change from baseline in HbA1c after 26 weeks of treatment.|Week 0, Week 26|The full analysis set (FAS) included all randomised subjects. Missing data were imputed using last observation carried forward (LOCF).||Percent (%) glycosylated haemoglobin||Standard Error|Least Squares Mean
671912|NCT01680328|Secondary|Estimated Mean Differences in the Volume of Backflow (uL) in the Thighs After Different Injection Volumes and Speeds as Compared to Needle Insertion|Backflow was measured after each injection by placing a filter paper over the injection site after the injection was given and until the liquid was absorbed. The size of the wet spot on the filter paper served as a measure of the backflow. The treatment effect on backflow was calculated as the least square mean estimate of the difference in backflow after injection in the abdomen at different volume and speed combinations.|2 minutes (±30sec) after each injection|All randomised subjects receiving at least one injection (possibly needle insertion only) were included in the full analysis set. One subject did not contribute to the analysis due to missing injection.||mcL||Standard Deviation|Mean
671913|NCT01680328|Secondary|Estimated Mean Differences in the Volume of Backflow (uL) in the Abdomen After Different Injection Volumes and Speeds as Compared to Needle Insertion|Backflow was measured after each injection by placing a filter paper over the injection site after the injection was given and until the liquid was absorbed. The size of the wet spot on the filter paper served as a measure of the backflow. The treatment effect on backflow was calculated as the least square mean estimate of the difference in backflow after injection in the abdomen at different volume and speed combinations.|2 minutes (±30sec) after each injection|All randomised subjects receiving at least one injection (possibly needle insertion only) were included in the full analysis set. One subject did not contribute to the analysis due to missing injection.||mcL||Standard Deviation|Mean
671917|NCT01680328|Primary|Injection Pain (VAS mm)|Calculated as the least square mean estimate of the difference in injection pain on a VAS (mm) between different factor levels corresponding to injection region, injection volume and injection speed (pain was assessed using an electronic VAS consisting of a 100 mm line where 0 mm corresponded to no pain and 100 mm corresponded to worst pain. After each injection, the subjects rated their pain perception at the electronic VAS by marking the 100 mm line).|1 minute (±30 sec) after each injection|All randomised subjects receiving at least one injection (possibly needle insertion only) were included in the full analysis set. A total of 4 subjects did not contribute to the analysis due to missing injections (2) and missing VAS evaluation (2).||mm||Standard Deviation|Mean
671918|NCT01680172|Primary|Hospital Anxiety Depression Scale- Depression Score (HADS-D)|Hospital Anxiety and Depression Scale (HADS) is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression. Cut-offs for identifying psychiatric distress has been reported in the literature to be >10 for anxiety and >8 for depression.|Baseline, 120 minutes|Study was terminated early due to slow accrual.||units on a scale||Standard Deviation|Mean
671919|NCT01680172|Primary|Hospital Anxiety and Depression Scale - Anxiety Score (HADS-A)|Hospital Anxiety and Depression Scale (HADS) is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression. Cut-offs for identifying psychiatric distress has been reported in the literature to be >10 for anxiety and >8 for depression.|Baseline, 120 minutes|Study was terminated early due to slow accrual.||units on a scale||Standard Deviation|Mean
671920|NCT01680159|Secondary|Assessment of Severity (Only for Patients With Pustular Psoriasis)|From 0 (best) to 17 (worst)|Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period|||units on a scale||Full Range|Mean
671921|NCT01680159|Secondary|Visual Analog Scale（VAS） of Pain Assessment by Subjects (Only for Patients With Psoriatic Arthritis)|From 0 (best) to 100 (worst)|Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period|||mm||Full Range|Median
671922|NCT01680159|Secondary|Percentage of Participants With Cleared and Minimal Skin Lesions of Physician Global Assessment (PGA) (Only for Patients With Plaque Psoriasis)|"The investigator or the subinvestigator made a global assessment of skin lesions in terms of the degree of erythema, induration, and scaling (scale), using the following 6-point scale (0 to 5). When the day of the assessment fell on a day on which study product was to be administered, the assessment was performed before the study product was administered. As a rule, the PGA for each patient were performed by the same investigator or subinvestigator throughout the study, unless there was a special reason why this was not done (e.g., the investigator or the subinvestigator changed jobs). Outcome measure data table is reported percentage of participants with Cleared and Minimal skin lesions.
0: Cleared, 1: Minimal, 2: Mild, 3: Moderate, 4: Marked, 5: Severe"|Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period|||percentage of participants|||Number
671923|NCT01680159|Secondary|Psoriasis Area and Severity Index (PASI) Score|Score range is 0-72. Higher values represent a worse outcome. The investigator or the subinvestigator examined the head, trunk, and upper and lower limbs, and assessed skin findings (erythema, induration, and scaling [scale]) at each of the regions and the extent of area affected. Total sores were added scores of the each regions.|Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period|||units on a scale||Full Range|Median
671924|NCT01680159|Primary|Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score|"The investigator or the subinvestigator examined the head, trunk, and upper and lower limbs, and assessed skin findings (erythema, induration, and scaling [scale]) at each of the regions and the extent of area affected. Total sores were calculated scores of the each regions.
When the day of the assessment fell on a day on which study product was to be administered, the assessment was performed before the study product was administered.
As a rule, the PASI score assessments for each patient were performed by the same investigator throughout the study, unless there was a special reason why this was not done (e.g., the investigator changed jobs).
The number and percentage of patients achieving a 75% improvement in their PASI scores at each assessment time point."|Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period|||percentage of participants|||Number
671925|NCT01680016|Primary|Number of Older Adults Who Reported Unsolicited Adverse Events (AEs)|The safety of Rabipur was assessed in terms of subjects(Older Adults) exposed to study vaccine who reported all Unsolicited AEs (including serious adverse events [SAE]s and AEs leading to subject withdrawal) from V1/day 1 (postvaccination) through V7/study termination day 43.|from V1/day 1 (postvaccination) through V7/study termination day 43|Analysis was done on the safety set, i.e. the subjects in the exposed population who provided postvaccination safety data.||Subjects|||Number
671926|NCT01680016|Primary|Number of Children Who Reported Unsolicited Adverse Events (AEs)|The safety of Rabipur was assessed in terms of subjects(Children) exposed to study vaccine who reported all Unsolicited AEs (including serious adverse events [SAE]s and AEs leading to subject withdrawal) from V1/day 1 (postvaccination) through V7/study termination day 43.|From V1/day 1 (postvaccination) through V7/study termination day 43|Analysis was done on the safety set, i.e. the subjects in the exposed population who provided postvaccination safety data.||Subjects|||Number
671927|NCT01680016|Secondary|GMCs of RVNA Titer 42 Days After the First Vaccination in Older Adults.|Immunogenicity was measured as the GMCs of RVNA titers, evaluated using the rapid fluorescent focus inhibition test, before vaccination and 42 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.|Before vaccination (day 1) and 42 days after first vaccination (day 43)|For the analysis of this outcome measure older adults aged ≥51 years were divided into two subgroups, i.e. ≥51 to ≤60 years and ≥61 years. Analysis was done on the PP set.||Concentration (IU/ml)||95% Confidence Interval|Geometric Mean
671928|NCT01680016|Secondary|GMCs of RVNA Titer 42 Days After First Vaccination in Children.|Immunogenicity was measured as the GMCs of RVNA titers, evaluated using the rapid fluorescent focus inhibition test, before vaccination and 42 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.|Before vaccination (day 1) and 42 days after first vaccination (day 43)|For the analysis of this outcome measure children aged ≥6 to ≤17 years were divided into two subgroups, i.e. ≥6 to ≤11 years and ≥12 to ≤17 years. Analysis was done on the PP set.||Concentration (IU/mL)||95% Confidence Interval|Geometric Mean
671930|NCT01680016|Primary|Number of Children Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur|Safety was assessed as the number of children who reported solicited local and systemic adverse events from day 1 up to and including day 7 after any vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.|Days 1 to 7 postvaccination|Analysis was done on the safety set, i.e. the subjects in the exposed population who provided postvaccination safety data.||Subjects|||Number
671931|NCT01680016|Secondary|Percentages of Older Adults With RVNA Titers ≥0.5 IU/mL 42 Days After First Vaccination of Rabipur|Immunogenicity was measured as the percentages of subjects who achieved RVNA titers ≥0.5 IU/mL, 42 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.|Before vaccination (day 1) and 42 days after first vaccination (day 43).|For the analysis of this outcome measure older adults aged ≥51 years were divided into two subgroups, i.e. ≥51 to ≤60 years and ≥61 years. Analysis was done on the PP set.||Percentages of subjects||95% Confidence Interval|Number
671932|NCT01680016|Secondary|Percentages of Children With RVNA Titers ≥0.5 IU/mL 42 Days After First Vaccination of Rabipur|Immunogenicity was measured as the percentages of subjects who achieved RVNA titers ≥0.5 IU/mL, 42 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.|Before vaccination (day 1) and 42 days after first vaccination (day 43).|For the analysis of this outcome measure children aged ≥6 to ≤17 years were divided into two subgroups, i.e. ≥6 to ≤11 years and ≥12 to ≤17 years. Analysis was done on the PP set.||Percentages of subjects||95% Confidence Interval|Number
671933|NCT01680016|Secondary|Percentages of Older Adults With RVNA Titers ≥0.5 IU/mL 14 Days After First Vaccination of Rabipur|Immunogenicity was measured as the percentages of subjects who achieved RVNA titers ≥0.5 IU/mL, 14 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.|Before vaccination (day 1) and 14 days after first vaccination (day 15).|For the analysis of this outcome measure older adults aged ≥51 years were divided into two subgroups, i.e. ≥51 to ≤60 years and ≥61 years. Analysis was done on the PP set.||Percentages of subjects||95% Confidence Interval|Number
671934|NCT01680016|Secondary|Percentages of Children With RVNA Titers ≥0.5 IU/mL 14 Days After First Vaccination of Rabipur|Immunogenicity was measured as the percentages of subjects who achieved RVNA titers ≥0.5 IU/mL, 14 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.|Before vaccination (day 1) and 14 days after first vaccination (day 15).|For the analysis of this outcome measure children aged ≥6 to ≤17 years were divided into two subgroups, i.e. ≥6 to ≤11 years and ≥12 to ≤17 years. Analysis was done on the PP set.||Percentages of subjects||95% Confidence Interval|Number
671935|NCT01680016|Primary|Non-inferiority in Immune Response of the Zagreb Postexposure Schedule of Rabipur to That of the Conventional Essen Postexposure Schedule of Rabipur as Measured by GMC of RVNA Titer 14 Days After the First Vaccination in Older Adults Aged ≥51 Years|Immunogenicity was measured as the GMCs of Rabies Virus Neutralizing Antibody (RVNA) titer , evaluated using the rapid fluorescent focus inhibition test, before vaccination and 14 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.|Before vaccination (day 1) and 14 days after first vaccination (day 15).|Analysis was done on the PP set.||IU/mL||95% Confidence Interval|Geometric Mean
671936|NCT01680016|Primary|Non-inferiority in Immune Response of the Zagreb Postexposure Schedule of Rabipur to That of the Conventional Essen Postexposure Schedule of Rabipur as Measured by GMC of RVNA Titer 14 Days After First Vaccination in Children Aged ≥6 to ≤17 Years.|Immunogenicity was measured as the geometric mean concentrations (GMCs) of rabies virus neutralizing antibody (RVNA) titer , evaluated using the rapid fluorescent focus inhibition test, before vaccination and 14 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.|Before vaccination (day 1) and 14 days after first vaccination (day 15)|Analysis was done on the per-protocol (PP) set, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis.||IU/mL||95% Confidence Interval|Geometric Mean
671937|NCT01679613|Secondary|Area Under the Curve From 0 to the Last Quantifiable Concentration (AUC0-tz)|"AUC0-tz represents the area under the plasma concentration-time curve of nintedanib from time 0 to the last quantifiable nintedanib plasma concentration.
For this endpoint, the measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities"|1 hour (h) before drug administration and 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 15h, 24h, 36h, 48h and 72h after the drug administration|TS||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
671938|NCT01679613|Primary|Maximum Measured Concentration (Cmax)|"Cmax represents the maximum concentration of nintedanib in plasma
For this endpoint, the measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities"|1 hour (h) before drug administration and 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 15h, 24h, 36h, 48h and 72h after the drug administration|TS||ng/mL||Geometric Coefficient of Variation|Geometric Mean
671939|NCT01679613|Primary|Area Under the Curve From 0 Extrapolated to Infinity (AUC0-∞)|"AUC0-∞ represents the Area under the concentration-time curve of nintedanib in plasma over the time interval from 0 extrapolated to infinity
For this endpoint, the measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities"|1 hour (h) before drug administration and 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 15h, 24h, 36h, 48h and 72h after the drug administration|The treated set (TS) includes all subjects who were dispensed study medication and were documented to have taken at least one dose of study medication (nintedanib or ketoconazole).||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
671940|NCT01679600|Primary|Peak Oxygen Uptake (V'O2peak)||4 weeks|||mL/min||Standard Deviation|Mean
671941|NCT01679314|Secondary|Change in Change in EuroQol, 5 Questions and 3 Levels (EQ-5D-3L), Visual Analogue Scale (VAS)|Visual analogue scale (VAS) 0-100 where 0 is the worst imaginable health state and 100 the best imaginable health state|Baseline vs 8 weeks|One patient in the Active AlphaCore group missing data at 8 weeks.||units on a scale||Standard Deviation|Mean
671958|NCT01679002|Secondary|AUC - Area Under the Plasma Concentration Versus Time Curve|"AUC - Area Under the Plasma Concentration Versus Time Curve for BIA 2-093 metabolites:
BIA 2-194 BIA 2-195 Oxcarbazepine"|pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 h post-dose|The results are related to overall population in the study devided by period of treatment.||ng*h/mL||Standard Deviation|Mean
671942|NCT01679314|Secondary|Number of Subjects With Adverse Events (AE)|"All AEs including but not limited to events reported by the subject or reported in response to an open question by the Clinical Investigator or member of this team, which fall into any of the above definitions must be recorded as an AE in the Case Report Form (CRF) and should include the following information.
Brief description of the event (diagnosis)
Start date (and time, if relevant)
Stop date (and time, if relevant) (or resolution)
Severity
Action taken regarding the medical device
Opinion on causality
Seriousness
Outcome"|Throughout the course of the study (baseline to the 4 month follow-up visit)|All subjects reporting any Adverse Event||participants|||Number
671943|NCT01679314|Secondary|Change in EuroQol, 5 Questions and 3 Levels (EQ5D-3L)|"The EQ-5D-3L (EuroQoL 5 questions and 3 answering levels) during the run-in period will be compared with the EQ-5D-3L during the treatment period. And treatment period will be compared to open label.
Rating of questions Level 1 no problems Level 2 some problems Level 3 Significant problems Worst case is 15 points and best case is 5 points using index"|Baseline vs 8 weeks|One patient in the Active AlphaCore group is missing data at 8 weeks.||participants|||Number
671944|NCT01679314|Secondary|Change in Forced Expiratory Volume (FEV1)|"Forced Expiratory Volume (FEV1): Maximum volume that can be exhaled in the first second - after maximum inhalation.
Change from baseline to week 8 between treatment groups"|Baseline vs 8 weeks|One subject in the Active AlphaCore group missing data at week 8||Percentage of predicted value||Standard Deviation|Mean
671945|NCT01679314|Secondary|Change 6 Minutes Walking Test|Six minutes walking test: Measure distance (meter) after 6 minutes walk. Change from Baseline between treatment groups|Baseline vs 8 weeks|One patient in the Active AlphaCore group is missing data at week 8||Meter||Standard Deviation|Mean
671946|NCT01679314|Secondary|Change in Borg Dyspnoea Scores|Borg dyspnoea scale (Physical activity test): 0 - 11 (Not at all effected - Extremely effected) The result show the change between the the treatment groups from baseline to week 8|Baseline vs 8 weeks|One subject in the Active AlphaCore device Group missing data at 8 weeks.||Scores on a scale||Standard Deviation|Mean
671947|NCT01679314|Primary|Chronic Obstructive Pulmonary Disease Assessment Test (CAT) Scores (Quality of Life and Symptoms) Changes Within a Treatment Period and Comparison Between the Two Groups|Chronic obstructive pulmonary disease Assessment Test (CAT) scores (Quality of life and symptoms) changes within a treatment period and comparison between the two groups. Eight (8) questions. The scale is rated from 0 to 5, min = 0, max = 5. Low rates = better, high rates = worse. Mean change in the period 8 weeks versus baseline.|8 weeks|One patient in the Active AlphaCore device Group missing data at 8 weeks.||units on a scale||95% Confidence Interval|Least Squares Mean
671948|NCT01679236|Secondary|Alcohol Use in Study Subjects vs Controls|Timeline follow back participant self-report of daily alcohol use.|2 weeks post quit day||||||
671949|NCT01679236|Primary|Smoking Abstinence|Smoking abstinence is measured by Carbon Monoxide Breath Testing in Controls vs Study Group subjects two weeks after the quit day|2 weeks post quit day|total enrolled||participants|||Number
671950|NCT01679197|Secondary|Body Weight||1 year|||kg||Standard Deviation|Mean
671951|NCT01679197|Secondary|Fasting Glucose||1 year|The number of participants analyzed at month 12 differs from the overall number analyzed at baseline because 4 participants dropped from the study before their month 12 visit.||mg/dL||Standard Deviation|Mean
671952|NCT01679197|Secondary|Fasting Lipids|Cholesterol, triglycerides, HDL cholesterol, and LDL together make up the lipid profile and must be reported together. We are reporting the lipid profile where the treatment group arm would normally be listed, though, we are looking at the same single arm population of 23 participants who received treatment in this study.|1 year|The number of participants analyzed at month 12 differs from the overall number analyzed at baseline because 4 participants dropped from the study before their month 12 visit.||mg/dL||Standard Deviation|Mean
671953|NCT01679197|Secondary|Liver Function Tests|AST and ALT are the liver function tests. We are reporting the liver function tests where the treatment group arm would normally be listed, though, we are looking at the same single arm population of 23 participants who received treatment in this study.|1 year|The number of participants analyzed at month 12 differs from the overall number analyzed at baseline because 4 participants dropped from the study before their month 12 visit.||IU/L||Standard Deviation|Mean
671954|NCT01679197|Secondary|Liver Fat by MRI and MR Spectroscopy|All enrolled patients will have a baseline MRI of the liver to evaluate liver volume and liver fat. For determination of hepatic fat content by MRI and MR spectroscopy in patients, a series of out-phase and in-phase MRI at multiple flip angles are used. By combination of out-phase and in-phase MRI at multiple flip-angles and TE times, relaxation-time effects can be removed to yield quantitative intra-hepatic (and other organs’) fractional fat content throughout the liver in a few breath-hold intervals.|1 year|The number of participants analyzed at month 12 differs from the overall number analyzed at baseline because 4 participants dropped from the study before their month 12 visit.||%fat||Standard Deviation|Mean
671955|NCT01679197|Primary|Liver Histopathology|Primary outcome will be the total non-alcoholic steatohepatitis (NASH) score read histopathologically from the liver biopsy samples. This outcome measure quantifies the severity of fatty liver disease. At baseline and at the end of the year, patients have undergone a transcutaneous liver biopsy and the specimens were graded for the severity of non-alcoholic fatty liver disease (NAFLD)/non-alcoholic steatohepatitis (NASH) pathology. Histological features of NAFLD/NASH were scored using the validated NASH-CRN (NASH Clinical Research Network) scoring system. This scoring system is the total of 4 subscales: steatosis (0-3), lobular inflammation (0-3), hepatocellular ballooning (0-2) and fibrosis (0-4), which are evaluated semi-quantitatively. The total scale range for this scoring system is 0-12, with 0 representing no features of fatty liver disease, and 12 representing the highest degree of fatty liver disease.|1 year|The number of participants analyzed at month 12 differs from the overall number analyzed at baseline because 4 participants dropped from the study before their month 12 visit.||units on a scale||Standard Deviation|Mean
671956|NCT01679028|Primary|Incidence of Adverse Drug Events and Serious Adverse Events|the Incidence of Adverse Drug Events and serious adverse events|30 days (after first dosing)|||adverse event|||Number
671957|NCT01679002|Secondary|Number of of Subjects Reporting at Least One Adverse Event|Number of of subjects reporting at least one adverse event.|8 weeks|The results are related to overall population in the study devided by period of treatment.||Number of of subjects reporting at least|||Number
684440|NCT01516879|Secondary|Change From Baseline in LDL-C at Week 52|Cholesterol was measured by means of ultracentrifugation.|Baseline and Week 52|Full Analysis Set||mg/dL||Standard Error|Least Squares Mean
671959|NCT01679002|Primary|Cmax - Maximum Observed Plasma Drug Concentration|"Cmax - maximum observed plasma drug concentration for BIA 2-093 metabolites:
BIA 2-194 BIA 2-195 Oxcarbazepine"|pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 h post-dose|The results are related to overall population in the study devided by period of treatment.||ng/mL||Standard Deviation|Mean
671960|NCT01678976|Other Pre-specified|Total of Subjects Reporting at Least One Adverse Event|Monitoring of Adverse Events throughout the study: Safety was evaluated from the number of reported adverse events (AEs) by patient|4 weeks|||subjects reporting at least 1 AE|||Number
671961|NCT01678976|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC)|Area under the plasma concentration versus time curve (AUC) to last measurable time point (AUC0-t) was acessed for BIA 2-093 metabolites (BIA 2-194; BIA 2-195) and Oxcarbazepine.|at pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 hours post-dose|Values are described for single dose of BIA 2-093 or oxcarbazepine respectively for Group 1 and 2.||ng*h/mL||Standard Deviation|Mean
671962|NCT01678976|Primary|Maximum Drug Concentration (Cmax)|Maximum observed plasma concentration (Cmax) was acessed for BIA 2-093 metabolites (BIA 2-194; BIA 2-195) and Oxcarbazepine.|at pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 hours post-dose|Values are described for single dose of BIA 2-093 or oxcarbazepine respectively for Group 1 and 2.||ng/mL||Standard Deviation|Mean
671963|NCT01678911|Secondary|Patient Global Impression of Change|Patient Global Impression of Change is a self-report questionnaire on which patient indicate their perceived impression of change since the start of the study given the following options: Very Much Improved, Much Improved, Minimally Improved, No Change, Minimally Worse, Much Worse, or Very much Worse.|4 Visits over 15 weeks|||participants|||Number
671964|NCT01678911|Secondary|Center for Epidemiologic Studies Depression Scale|The CES-D 10 is a 10-item questionnaire that has been validated for the assessment of depressive symptomatology. The Depression Scale is a scale with a sum score from 0 - 30, where 0 = no Depression and 30 = the most Depression.|4 visits over 15 week period|||units on a scale||Standard Deviation|Mean
671965|NCT01678911|Secondary|Pain Disability Index|The PDI is a seven-item, validated instrument that assesses perceived disability in seven key life areas. It provides a total disability score, and is an indirect measure of self efficacy. The Pain Disability Scale is a scale from 0 - 70, where 0 = no Disability and 70 = the most Disability.|4 visits over an 8 week period|||units on a scale||Standard Deviation|Mean
671966|NCT01678911|Secondary|Pain Anxiety Symptoms Scale|The Pain Anxiety Symptoms Scale (PASS) is an anxiety scale from 0 - 100, where 0 = no anxiety and 100 = the most anxiety.|4 Visits over an 8 week period|||units on the PASS scale||Standard Deviation|Mean
671967|NCT01678911|Primary|McGill Pain Questionnaire - Short Form|The MPQ-SF is a well-validated pain measure that permits separation of the sensory and affective components of pain, which are averaged to compute a total score. The scale ranges from 0-10 (0=no pain, 10=the most pain).|4 Visits over a 15 week period|||units on a scale||Standard Deviation|Mean
671968|NCT01678885|Secondary|Device Predictions of % Weight Change During and After an 8-week LCD|This secondary aim of the study was evaluated with linear regression analysis to determine if TEE, AEE, or measures of posture allocation predicted weight loss during the 8-week LCD. Percent weight change from diet initiation to termination was the dependent variable for the weight loss regressions. Of the 87 participants considered for these secondary analyses, five were excluded because they did not finish baseline accelerometry assessment, and an additional five were excluded because they did not enter the LCD phase due to BMI’s < 25. Finally, seven more participants from this original sample were excluded because they did not successfully complete all aspects of the DLW dosing period. Finally, an additional 4 subjects were lost to follow up during the 8-week LCD period. Thus, 66 participants were included in the analysis|8 weeks|Participants from sub-study 1 and 2 combined were used in this analysis.||R squared|||Number
671969|NCT01678885|Secondary|Total Energy Expenditure (TEE) and Activity Energy Expenditure (AEE) Predictions From Actical, IDEEA, and Sensewear Monitors (kcal/Day)|Bland-Altman analyses compared the TDEE and AEE from the Sensewear® and IDEEA and Actical monitors to the DLW data from the week participants wore the monitors. Only the week of DLW data that corresponded with the wearing of the monitors was used for this analysis.|1 week|Of the 87 participants considered from phase 1 of sub-studies 1 and 2, five were excluded because they did not finish baseline accelerometry assessment, five were excluded because they did not enter the LCD due to BMI’s < 25. Seven were excluded because they did not successfully complete all aspects of the DLW dosing period.||kcal/day||Standard Deviation|Mean
671970|NCT01678885|Secondary|Weight Change|The secondary aim was to test if posture allocation (the amount of time spent engaging in certain behaviors e.g., sitting, walking, running, changing positions and the energy burned during these activities) predicts weight change over one year following a period of weight loss.|1 year|Weight change was evaluated from all participants who received the low calorie diet in sub-studies 1 and 2 combined.||kg||Standard Deviation|Mean
671971|NCT01678885|Primary|ENERGY BALANCE EQUATION, PHASE I, ONE SUB-STUDY|A new method of digital photography of foods to measure the energy intake (EI) and macronutrient intake of free-living humans was tested. Digital photography (RFPM) EI was tested against measured food provisions during an in-feeding period and against EI measured with doubly labeled water (DLW) during free-living conditions for 1 week. EI measured by directly weighing food provisions in the clinic over two days and measuring food intake during free-living conditions over one week with the DLW.|~6 days|Free-living energy intake data were analyzed from the 40 participants who completed the protocol and provided urine samples for doubly labeled water analysis. This primary outcome measure was limited to one sub-study.||kCal||Standard Deviation|Mean
671972|NCT01678846|Secondary|Safety and Well-being at School|"Five questions. Each question asked with response options: all the time, most of the time, sometimes, never:
I feel that my teachers care about me. I feel safe in school. I feel like I belong at school. I like to spend time at school. I am scared of my teachers (reverse coded). Scores summed, modelled as a continuous variable. Range 0 (low) to 15 (high). Higher score is better safety and well-being at school."|At 2 year follow-up|||units on a scale||Standard Deviation|Mean
671973|NCT01678846|Secondary|Educational Achievement: Word Recognition in English|Word recognition in English(words per minute). Early Grade Reading Assessment, Uganda version. Calculated as number of words read correctly (out of a maximum of 50), divided by the time (out of a maximum of 60 seconds).|2-year follow-up|||words per minute||Standard Deviation|Mean
671976|NCT01678820|Secondary|Percentage of Participants With A1C Level <7% at Week 16|Percentage of participants achieving glycemic goal (A1C <7%) after 16 weeks of treatment. Data as observed.|Week 16|FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).||Percentage of participants|||Number
671977|NCT01678820|Secondary|Percent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C) at Week 16|Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.|Baseline and Week 16|FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).||Percent change||95% Confidence Interval|Least Squares Mean
671978|NCT01678820|Secondary|Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Week 16|Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.|Baseline and Week 16|FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).||Percent change||95% Confidence Interval|Least Squares Mean
671979|NCT01678820|Secondary|Percent Change From Baseline in Triglycerides (TG) at Week 16|Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.|Baseline and Week 16|FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).||Percent change||95% Confidence Interval|Mean
671980|NCT01678820|Secondary|Percent Change From Baseline in Non-high Density Lipoprotein Cholesterol (Non-HDL-C) at Week 16|Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.|Baseline and Week 16|FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).||Percent change||95% Confidence Interval|Least Squares Mean
671981|NCT01678820|Secondary|Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 16|Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.|Baseline and Week 16|FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).||Percent change||95% Confidence Interval|Least Squares Mean
671982|NCT01678820|Secondary|Percent Change From Baseline in Total Cholesterol (TC) at Week 16|Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.|Baseline and Week 16|FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).||Percent change||95% Confidence Interval|Least Squares Mean
671983|NCT01678820|Secondary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 16|Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.|Baseline and Week 16|FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).||Percent change||95% Confidence Interval|Least Squares Mean
671984|NCT01678820|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 16|Change from baseline reflects the Week 16 value minus the Week 0 value.|Baseline and Week 16|FAS population defined as all randomized participants who took at least one dose of study drug and who had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).||mg/dL||95% Confidence Interval|Least Squares Mean
671985|NCT01678820|Secondary|Change From Baseline in A1C at Week 16 (Sitagliptin/Simvastatin FDC vs. Simvastatin)|A1C is measured as percent. Thus, this change from baseline reflects the Week 16 A1C percent minus the Week 0 A1C percent. This primary outcome measure only includes results for sitagliptin/simvastatin FDC vs. simvastatin. Results for sitagliptin are presented above under primary outcome measures.|Baseline and Week 16|FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).||Percent||95% Confidence Interval|Least Squares Mean
671986|NCT01678820|Primary|Number of Participants Who Discontinued Study Drug Due to an Adverse Event|Excludes data after rescue therapy. Adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product.|Up to 16 weeks|All participants as treated population defined as all randomized participants who received at least one dose of study drug.||Participants|||Number
671987|NCT01678820|Primary|Number of Participants Who Experienced at Least One Adverse Event (AE)|Excludes data after rescue therapy. Adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product.|Up to 16 weeks for non-serious AEs, up to 18 weeks for serious AEs|All participants as treated population defined as all randomized participants who received at least one dose of study drug.||Participants|||Number
671988|NCT01678820|Primary|Change From Baseline in Hemoglobin A1C (A1C) at Week 16 (Sitagliptin/Simvastatin FDC vs. Sitagliptin)|A1C is measured as percent. Thus, this change from baseline reflects the Week 16 A1C percent minus the Week 0 A1C percent. This primary outcome measure only includes results for sitagliptin/simvastatin FDC vs. sitagliptin. Results for simvastatin are presented below under secondary outcome measures.|Baseline and Week 16|Full analysis set (FAS) population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).||Percent||95% Confidence Interval|Least Squares Mean
672159|NCT01675453|Secondary|Fluid Balance|Net fluid balance at the end of surgery equals the sum of all infusions minus the urine output. Net fluid balance at postoperative day 1 equals the sum of all infusions minus the urine output and blood loss.|24 hours||||||
672160|NCT01675453|Secondary|Cardiac Index||24 hours||||||
671989|NCT01678807|Primary|Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event|The percentage of participants who had study treatment stopped due to an AE. Discontinuations were reported for all randomized participants who received ≥1 dose of study treatment.|From first dose to last dose of treatment, up to 28 days|All randomized participants who receive at least one dose of study treatment||Percentage of participants|||Number
671990|NCT01678807|Primary|Percentage of Participants Who Experienced At Least One Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol-specified procedure, whether or not considered related to the medicinal product/protocol-specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE. A serious adverse event (SAE) was an AE that resulted in death, was life threatening, resulted in persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a cancer, was associated with an overdose, was another important medical event.|From first dose to last dose of treatment plus 2 weeks of follow-up, up to 42 days|All randomized participants who receive at least one dose of study treatment||Percentage of participants|||Number
671991|NCT01678313|Secondary|Change From Baseline in the International Prostate Symptom Score (IPSS) Questionnaires|"Efficacy:
Change from Baseline in the International Prostate Symptom Score (IPSS) from baseline and 3 months The International Prostate Symptom Score (IPSS) is an 7 symptom questions including 4 voiding questions (IPSS Voiding), 3 storage questions (IPSS Storage) The symptom score have 6-point scale ranging from 0 Not at all to 5 Almost always.
Total IPSS score = IPSS voiding + IPSS Storage Rang = 0 to 35 (asymptomatic to very symptomatic). Mild = 0 to 7; Moderate = 8 to 19; Severe = 20 to 35
Change = Month 3 minus Baseline value"|Baseline and 3 months after initial treatment|||units on a scale||Standard Deviation|Mean
671992|NCT01678313|Secondary|Change From Baseline in the IPSS Subscore (IPSS Storage) Questionnaires|"Efficacy:
Change from Baseline in the IPSS Storage from baseline and 3 months The IPSS subscore (IPSS Storage) is a 3 symptom questions. The symptom score have 6-point scale ranging from 0 Not at all to 5 Almost always. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom.
The total IPSS Storage score can therefore range from 0 to 15 (asymptomatic to very symptomatic).
Change = Month 3 minus Baseline value"|Baseline and 3 months after initial treatment|||units on a scale||Standard Deviation|Mean
671993|NCT01678313|Secondary|Change From Baseline in the IPSS Subscore (IPSS Voiding) Questionnaires|"Efficacy:
Change from Baseline in the IPSS Voiding from baseline and 3 months. The IPSS subscore (IPSS Voiding) questionnaires is a 4 symptom questions. The symptom score have 6-point scale ranging from 0 Not at all to 5 Almost always. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom.
The total IPSS Voiding score can therefore range from 0 to 20 (asymptomatic to very symptomatic).
Change = Month 3 minus Baseline value"|Baseline and 3 months after initial treatment|||units on a scale||Standard Deviation|Mean
671994|NCT01678313|Secondary|Change From Baseline in the Maximum Flow Rate (Qmax)|"Efficacy:
Change from Baseline in the maximum flow rate (Qmax) from baseline and 3 months Change = Month 3 minus Baseline value"|Baseline and 3 months after initial treatment|||mL/s||Standard Deviation|Mean
671995|NCT01678313|Secondary|Change From Baseline in the Void Volume (VV)|"Efficacy:
Change from Baseline in the Void Volume (VV) from baseline and 3 months Change = Month 3 minus Baseline value"|Baseline and 3 months after initial treatment|||mL||Standard Deviation|Mean
671996|NCT01678313|Primary|Change From Baseline in the Serum Prostate Specific Antigen (PSA) Level|"Efficacy:
Change from Baseline in the serum PSA level from baseline and 3 months Change = Month 3 minus Baseline value"|Baseline and 3 months after initial treatment|||ng/mL||Standard Deviation|Mean
671997|NCT01678196|Secondary|Caregiver Burden|Caregiver Burden Scale (CBS). The CBS is a 16 items scale assessing caregiver burden. It has 16 items rated from 1 (not at all) to 5 (extremely) distressed or burdened. Scores reported are the total scale scores, calculated as the mean of the 16 items, with a range from 1 (low burden) to 5 (high burden).|3 months post-randomization|Sample sizes are smaller than total sample size due to missing questionnaire data.||units on a scale||Standard Deviation|Mean
671998|NCT01678196|Secondary|Family Functioning|Relationship Happiness Scale. The RHS is a 9 item scale of general happiness in close relationships. The total score is reported here, reflecting the mean of the 9 items rated on a scale of 1 (completely unhappy) to 10 (completely happy). Higher total scores reflect greater relationship happiness.|3 months after the initiation of the intervention|Sample sizes are smaller than the overall sample due to missing questionnaire data.||units on a scale||Standard Deviation|Mean
671999|NCT01678196|Secondary|Family Member Psychosocial Wellbeing: Brief Symptom Inventory - 18|Brief Symptom Inventory - 18 (Derogatis, 1993) is an 18 item measure of general mental health symptoms and distress. The total score is used, which is the mean of 18 items rated from 0 (not at all) to 4 (extremely) distressing. Total scores range from 0 (low distress) to 4 (high distress).|3 months after initiation of the intervention|Group sample sizes are smaller than total sample sizes due to missing data.||units on a scale||Standard Deviation|Mean
672000|NCT01678196|Primary|Veteran Engagement in VA Mental Health Services|Administrative data on mental health service utilization for Veterans will be compared for those whose family members receive the intervention (VA-CRAFT) and those who do not.|3 months after initiation of the intervention|||participants|||Number
672001|NCT01678131|Primary|Number of Participants From Whom Detectable Concentrations of Hepatic Vaniprevir Are Obtained by FNA|Liver samples were collected by FNA at 3 of 5 of the following specified postdose timepoints: 3, 12, 24, 48 and 72 hours after a single vaniprevir dose on Day 7. The technical success of the FNA procedure was established for a participant if vaniprevir was detected from at least 2 of the 3 FNA collection timepoints.|Day 7 up to Day 10 at 3 of the following timepoints: 3, 12, 24, 48 and 72 hours postdose|Participants treated with vaniprevir who had hepatic FNA collected at 3 timepoints. One participant from the 300 mg Vaniprevir + Peg-IFN/RBV treatment group, and one participant from the 600 mg Vaniprevir + Peg-IFN/RBV treatment group discontinued treatment prior to collection of 3 FNAs, and were therefore excluded from the analysis.||Participants|||Number
672161|NCT01675453|Secondary|Oxygen Delivery|Oxygen delivery index (DO2I) will be used to assess this outcome measure.|24 hours||||||
672002|NCT01677988|Other Pre-specified|CTC Expression|To determine and evaluate the correlation between expression or biomarkers in the CTCs and expression of biomarkers in resected tissue specimens within the same cancer patient.|2 years|The CTC expression endpoint was added as an amendment. No subjects were enrolled to the study after this amendment was approved, so data for this outcome was not collected or analyzed.|||||
672003|NCT01677988|Other Pre-specified|CTC Analysis|To evaluate and describe CTC numbers, CTC phenotype characteristics and effectiveness/rate of CTC culturing techniques from patients with pancreatic adenocarcinoma.|End of study|The CTC analysis was added as an amendment. No subjects were enrolled to the study after this amendment was approved, so data for this outcome was not collected or analyzed.|||||
672004|NCT01677988|Other Pre-specified|Feasibility Objective|The feasibility of treating patients with localized pancreatic head adenocarcinoma with this neoadjuvant regimen will be evaluated by estimating the proportion of patients completing five of six planned doses. The analysis population will be the ITT population.|From enrollment to end of chemotherapy part of the study|The number of subjects who had 5-6 doses of neoadjuvant regimen||participants|||Number
672005|NCT01677988|Secondary|Overall Survival:|Overall survival is defined as the time from enrollment to death from any cause. Patients still alive at the end of follow up will have their survival time censored at the last date of contact.|2 years|The study terminated early, prior to the end of the follow up period for all subjects. At the time of study termination, one subject had expired and the time from enrollment to death for that subject is reported below.||days|||Number
672006|NCT01677988|Secondary|Time to Recurrence:|Time to recurrence is defined as the time from surgical resection to disease recurrence or death from any cause. Patients who have not recurred at the end of follow up will have their recurrence time censored at the last date of contact.|2 years|The study terminated early, prior to the follow up period being completed. Only one subject had surgery and that subject is still alive at the time of study termination, so time to recurrence cannot be estimated.|||||
672007|NCT01677988|Secondary|Histopathologic Tumor Response|Estimate the rate of good histopathologic response as the proportion of grade I and II responders. The analysis population for this objective is the ITT population. Any patient for whom a surgical sample is not available will be considered a poor-responder.|at the time of surgery|Only subjects who had surgery were included in this outcome measure.||grade II responder|||Number
672008|NCT01677988|Secondary|Radiographic Tumor Response|The rate of CR, PR, SD and PD will be estimated as described in Section 14B prior to chemoradiation start and prior to surgery. The analysis population for estimation of radiographic response rate will be the ITT population.|From enrollment to Surgery|All subjects enrolled and had a response assessment are included in the outcome measure below.||participants|||Number
672009|NCT01677988|Primary|Estimate the R0/R1 Resection Rate|Estimate the R0/R1 resection rate as the proportion of patients with R0 or R1 resection status based on the ITT population. R0 resection status is macroscopic complete removal of tumor by non-contaminated operation, with neither macroscopic nor microscopic residual tumor. R1 resection status is macroscopic complete removal of tumor by non-contaminated operation, with microscopic residual tumor.|at time of surgery|Only subjects who had surgery were included in the outcome measure data.||participants|||Number
672010|NCT01677936|Secondary|Systolic Blood Pressure|Raisins versus snacks: mmHg change in systolic blood pressure at week 12|12 weeks.|||mmHg||Standard Deviation|Mean
672011|NCT01677936|Primary|Postprandial Glucose Levels|Raisins versus snacks: percent change in postprandial glucose levels at week 12|12 weeks|||percent||Standard Deviation|Mean
672012|NCT01677910|Secondary|Change From Baseline in Abdominal Pain|To assess sensation/severity of nausea on a daily basis, patients recorded their response using a 4-point scale: 0=none, 1=mild, 2=moderate, 3=severe.|Baseline and 12 weeks|ITT Population||units on a scale||Standard Deviation|Mean
672013|NCT01677910|Secondary|Change From Baseline in the Number of Cutaneous Flushing Episodes||Baseline and 12 weeks|ITT Population||Number of flushing episodes||Standard Deviation|Mean
672014|NCT01677910|Secondary|Change From Baseline in Urinary 5-hydroxyindoleacetic Acid (5-HIAA) Levels||Baseline and 12 weeks|||mg/24 hours||Standard Deviation|Mean
672015|NCT01677910|Primary|Number of Participants With Treatment-emergent Adverse Events||12 weeks|Safety Population||Participants|||Count of Participants
672016|NCT01677910|Primary|Change From Baseline in Number of Daily Bowel Movements||Baseline and 12 weeks|ITT Population||number of bowel movements||Standard Deviation|Mean
672017|NCT01677858|Secondary|Mean Residence Time Observed From Time Zero to Infinity (MRT0-∞) for Carfilzomib||Day 1 cycle 1 (20 mg/m² carfilzomib), cycle 1 day 15 (phase 1 70 and 88 mg/m² carfilzomib), and cycle 2 day 15 (phase 2 70 mg/m² carfilzomib) from predose to 4 hours after the end of the infusion.|Pharmacokinetic (PK) analyses were conducted for participants assigned to cohorts 3 and 4 in phase 1 (70 and 88 mg/m² carfilzomib) and a subset of participants in phase 2; only participants for whom PK parameters could be calculated were included in the analyses.||hours||Geometric Coefficient of Variation|Geometric Mean
672018|NCT01677858|Secondary|Clearance of Carfilzomib After IV Infusion||Day 1 cycle 1 (20 mg/m² carfilzomib), cycle 1 day 15 (phase 1 70 and 88 mg/m² carfilzomib), and cycle 2 day 15 (phase 2 70 mg/m² carfilzomib) from predose to 4 hours after the end of the infusion.|Pharmacokinetic (PK) analyses were conducted for participants assigned to cohorts 3 and 4 in phase 1 (70 and 88 mg/m² carfilzomib) and a subset of participants in phase 2; only participants for whom PK parameters could be calculated were included in the analyses.||liters/hour||Geometric Coefficient of Variation|Geometric Mean
672019|NCT01677858|Secondary|Terminal Half-life (T1/2,z) for Carfilzomib||Day 1 cycle 1 (20 mg/m² carfilzomib), cycle 1 day 15 (phase 1 70 and 88 mg/m² carfilzomib), and cycle 2 day 15 (phase 2 70 mg/m² carfilzomib) from predose to 4 hours after the end of the infusion.|Pharmacokinetic (PK) analyses were conducted for participants assigned to cohorts 3 and 4 in phase 1 (70 and 88 mg/m² carfilzomib) and a subset of participants in phase 2; only participants for whom PK parameters could be calculated were included in the analyses.||hours||Geometric Coefficient of Variation|Geometric Mean
672041|NCT01677767|Primary|Number of Participants With Co-morbidity Treated With C.E.R.A|Co-morbidity is the presence of one or more additional disorders (or diseases) co-occurring with a primary disease or disorder; or the effect of such additional disorders or diseases. Co-morbid participants with renal and urinary disorders, vascular disorders, metabolism and nutrition disorders were reported.|Up to Week 24|The safety population included all participants enrolled into the study.||Number of participants|||Number
672020|NCT01677858|Secondary|Volume of Distribution Observed at Steady State (Vss) for Carfilzomib||Day 1 cycle 1 (20 mg/m² carfilzomib), cycle 1 day 15 (phase 1 70 and 88 mg/m² carfilzomib), and cycle 2 day 15 (phase 2 70 mg/m² carfilzomib) from predose to 4 hours after the end of the infusion.|Pharmacokinetic (PK) analyses were conducted for participants assigned to cohorts 3 and 4 in phase 1 (70 and 88 mg/m² carfilzomib) and a subset of participants in phase 2; only participants for whom PK parameters could be calculated were included in the analyses.||liters||Geometric Coefficient of Variation|Geometric Mean
672021|NCT01677858|Secondary|Area Under the Plasma Concentration-time Curve During the Dosing Interval (0-168 Hours) for Carfilzomib||Day 1 cycle 1 (20 mg/m² carfilzomib), cycle 1 day 15 (phase 1 70 and 88 mg/m² carfilzomib), and cycle 2 day 15 (phase 2 70 mg/m² carfilzomib) from predose to 4 hours after the end of the infusion.|Pharmacokinetic (PK) analyses were conducted for participants assigned to cohorts 3 and 4 in phase 1 (70 and 88 mg/m² carfilzomib) and a subset of participants in phase 2; only participants for whom PK parameters could be calculated were included in the analyses.||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
672022|NCT01677858|Secondary|Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUCinf) fo Carfilzomib||Day 1 cycle 1 (20 mg/m² carfilzomib), cycle 1 day 15 (phase 1 70 and 88 mg/m² carfilzomib), and cycle 2 day 15 (phase 2 70 mg/m² carfilzomib) from predose to 4 hours after the end of the infusion.|Pharmacokinetic (PK) analyses were conducted for participants assigned to cohorts 3 and 4 in phase 1 (70 and 88 mg/m² carfilzomib) and a subset of participants in phase 2; only participants for whom PK parameters could be calculated were included in the analyses.||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
672023|NCT01677858|Secondary|Area Under the Plasma Concentration-time Curve From Time 0 to the Time of Last Quantifiable Concentration (AUClast) for Carfilzomib||Day 1 cycle 1 (20 mg/m² carfilzomib), cycle 1 day 15 (phase 1 70 and 88 mg/m² carfilzomib), and cycle 2 day 15 (phase 2 70 mg/m² carfilzomib) from predose to 4 hours after the end of the infusion.|Pharmacokinetic (PK) analyses were conducted for participants assigned to cohorts 3 and 4 in phase 1 (70 and 88 mg/m² carfilzomib) and a subset of participants in phase 2; only participants for whom PK parameters could be calculated were included in the analyses.||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
672024|NCT01677858|Secondary|Maximum Plasma Concentration of Carfilzomib||Day 1 cycle 1 (20 mg/m² carfilzomib), cycle 1 day 15 (phase 1 70 and 88 mg/m² carfilzomib), and cycle 2 day 15 (phase 2 70 mg/m² carfilzomib) from predose to 4 hours after the end of the infusion.|Pharmacokinetic (PK) analyses were conducted for participants assigned to cohorts 3 and 4 in phase 1 (70 and 88 mg/m² carfilzomib) and a subset of participants in phase 2; only participants for whom PK parameters could be calculated were included in the analyses.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
672025|NCT01677858|Secondary|Time to Maximum Plasma Concentration of Carfilzomib||Day 1 cycle 1 (20 mg/m² carfilzomib), cycle 1 day 15 (phase 1 70 and 88 mg/m² carfilzomib), and cycle 2 day 15 (phase 2 70 mg/m² carfilzomib) from predose to 4 hours after the end of the infusion.|Pharmacokinetic (PK) analyses were conducted for participants assigned to cohorts 3 and 4 in phase 1 (70 and 88 mg/m² carfilzomib) and a subset of participants in phase 2; only participants for whom PK parameters could be calculated were included in the analyses.||hours||Full Range|Median
672026|NCT01677858|Secondary|Number of Participants With Adverse Events|Adverse events were graded using National Cancer Institute-Common Terminology Criteria for Adverse Events (version 4.03).|From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.|Participants who received at least 1 dose of any investigational product (carfilzomib or dexamethasone).||Participants|||Count of Participants
672027|NCT01677858|Secondary|Duration of Response|Duration of response (DOR) was defined as the time from first evidence of PR or better to disease progression or death due to any cause. DOR was calculated using Kaplan-Meier methods; Participants with no baseline disease assessments, starting a new anticancer therapy before documentation of disease progression or death, death or disease progression immediately after more than 1 consecutively missed disease assessment visit, or alive without documentation of disease progression before the data cut-off date were censored.|From randomization until the data cut-off date of 22 July 2016; median follow-up time for DOR was 14.3 months|Participants who received at least 1 dose of any investigational product (carfilzomib or dexamethasone) with a best overall response of sCR, CR, VGPR, or PR.||months||95% Confidence Interval|Median
672028|NCT01677858|Secondary|Time To Progression|Time to progression (TTP) was defined as the time from first dose to disease progression evaluated by the investigator according to the International Myeloma Working Group Uniform Response Criteria (IMWG-URC). TTP was calculated using Kaplan-Meier methods; participants with no baseline and/or post-baseline disease assessments, who started a new anticancer therapy before documentation of disease progression or death, died or had disease progression immediately after more than 1 consecutively missed disease assessment visit or who were alive without documentation of disease progression before the data cutoff date were censored.|From randomization until the data cut-off date of 22 July 2016; median follow-up time for TTP was 13.4 months|Participants who received at least 1 dose of any investigational product (carfilzomib or dexamethasone).||months||95% Confidence Interval|Median
672029|NCT01677858|Secondary|Progression-free Survival|"Progression-free survival (PFS) was defined as the time from first dose to the earlier of disease progression or death due to any cause. The duration of PFS was calculated using Kaplan-Meier methods; participants with no baseline and/or post-baseline disease assessments, who started a new anticancer therapy before documentation of disease progression or death, died or had disease progression immediately after more than 1 consecutively missed disease assessment visit or who were alive without documentation of disease progression before the data cutoff date were censored.
Participants were evaluated for disease response and progression by the investigator according to the IMWG-URC."|From randomization until the data cut-off date of 22 July 2016; median follow-up time for PFS was 13.8 months|Participants who received at least 1 dose of any investigational product (carfilzomib or dexamethasone).||months||95% Confidence Interval|Median
672040|NCT01677767|Primary|Mean Time Required to Achieve Target Hemoglobin Range|The target range of hemoglobin (Hb) was 10-12 gram/deciliter (g/dL). Time to achieve target range = (Date of Hb evaluation when participant achieved target Hb range at first time – visit date of first dosing) + 1|Up to Week 24|ITT population included all the participants who received at least 1 dose of C.E.R.A (Week 0) and for whom data for at least one follow-up variable was available. The analysis population reflects those participants whose Hb value was less than (<) 10 g/dL at enrollment.||Week||Standard Deviation|Mean
672030|NCT01677858|Secondary|Clinical Benefit Response Rate|Clinical benefit rate was defined as the percentage of participants whose best response was sCR, CR, VGPR, PR, or minimal response (MR), where MR is defined by the European Group for Blood and Marrow Transplant (EBMT) criteria as a 25% to 49% reduction in the level of serum M-protein or a 50% to 89% reduction in 24-hour urinary M-protein, which still exceeds 200 mg /24 hour, maintained for a minimum of 8 weeks.|Disease response was assessed once every treatment cycle (28 days) and 30 days after last dose; the median overall treatment duration was 33.6 weeks.|Participants who received at least 1 dose of any investigational product (carfilzomib or dexamethasone).||percentage of participants||95% Confidence Interval|Number
672031|NCT01677858|Primary|Overall Response Rate (ORR)|"Disease response was evaluated by the investigator according to the International Myeloma Working Group Uniform Response Criteria (IMWG-URC). ORR was defined as the percentage of participants with a best overall response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR).
sCR: As for CR, normal serum free light chain (SFLC) ratio and no clonal cells in bone marrow (BM).
CR: No immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and < 5% plasma cells in BM.
VGPR: Serum and urine M-protein detectable by immunofixation but not electrophoresis or ≥ 90% reduction in serum M-protein with urine M-protein <100 mg/24 hours. A ≥ 50% reduction in the size of soft tissue plasmacytomas if present at baseline.
PR: ≥ 50% reduction of serum M-protein and reduction in urine M-protein by ≥ 90% or to < 200 mg/24 hours. A ≥ 50% reduction in the size of soft tissue plasmacytomas if present at baseline."|Disease response was assessed once every treatment cycle (28 days) and 30 days after last dose; the median overall treatment duration was 33.6 weeks.|Participants who received at least 1 dose of any investigational product (carfilzomib or dexamethasone).||percentage of participants||95% Confidence Interval|Number
672032|NCT01677858|Primary|Phase 1: Number of Participants With Dose-limiting Toxicities (DLTs)|"The MTD was defined as the highest carfilzomib dose at which < 33% of participants had a treatment-related DLT during the first 28-day cycle. A DLT was categorized as nonhematologic or hematologic and defined as follows:
Nonhematologic:
≥ grade 3 nonhematological toxicity (excluding nausea, vomiting, diarrhea, fatigue lasting < 14 days, increased serum creatinine or electrolyte abnormalities not clinically significant or requiring treatment)
≥ grade 3 acute kidney injury (creatinine > 3 x baseline or > 4.0 mg/dL) lasting > 72 hours
≥ grade 3 nausea, vomiting, or diarrhea uncontrolled by maximal antiemetic/antidiarrheal therapy
Hematologic:
grade 4 neutropenia (absolute neutrophil count [ANC] < 500/mm³) for > 7 days
febrile neutropenia (ANC < 1000/mm³ with a fever ≥ 38.3ºC) of any duration
grade 4 thrombocytopenia (< 25 000/mm³) for > 14 days, despite holding treatment
grade 3 or 4 thrombocytopenia (< lower limit of normal) associated with > grade 1 bleeding"|28 days|Participants in phase 1 who received at least 1 dose of any investigational product (carfilzomib or dexamethasone).||participants|||Number
672033|NCT01677767|Primary|Percentage of Participants Who Had Received Treatment With Other Erythropoiesis-Stimulating Agents Maintaining Hb Level Within 1 Gram/Deciliter of Baseline Value During Study Period in Participants.|Percentage of participants maintaining Hb level within 1 g/dL of baseline value during study period who had received treatment with other Erythropoiesis-Stimulating Agents (ESAs) were reported.|Up to Week 24|ITT population included all the participants who received at least 1 dose of C.E.R.A (Week 0) and for whom data for at least one follow-up variable was available. The analysis population reflects those participants who had been on other ESAs and had Hb greater than or equal to (≥)10 g/dL at baseline.||Percentage of participants|||Number
672034|NCT01677767|Secondary|Number of Participants Received Concomitant Medications|Medications that were used during the study treatment period (from the first dose date of study medication to the end of the study) were included as concomitant medications. The prescribed concomitant medications (in greater than or equal to 10% of participants) in the study were prazosin, torasemide, vitamin and nutritional supplements, omeprazole, amlodipine, calcium supplements, calcitriol, and clonidine. Participants treated with the each of these concomitant medications were reported.|Up to Week 24|The safety population included all participants enrolled into the study||Number of participants|||Number
672035|NCT01677767|Secondary|Evaluation of Dose Per Injection of C.E.R.A|The dosing and titration of C.E.R.A treatment were at the discretion of the investigator in accordance with local clinical practice or approved prescribing information. Mean dose per injection of C.E.R.A received by participants was reported.|Up to Week 24|The safety population included all participants enrolled into the study||Microgram||Standard Deviation|Mean
672036|NCT01677767|Secondary|Evaluation of Route of Administration for C.E.R.A|C.E.R.A. was administered by Intravenous (IV) and Subcutaneous (SC) route of administration. The frequency (number of injections) for both of these routes of administration used in the study was reported.|Up to Week 24|The safety population included all participants enrolled into the study||Number of injections|||Number
672037|NCT01677767|Secondary|Mean Time Spent by Participants in the Hb Target Range|Maintenance of target Hb was evaluated by assessing the mean time spent by participants in target Hb range. The target Hb range in the study was 10-12 g/dL.|Up to Week 24|ITT population included the participants who received at least 1 dose of C.E.R.A (Week 0) and for whom data for at least one follow-up variable was available.||Week||Standard Deviation|Mean
672038|NCT01677767|Secondary|Number of Participants Achieving Hb Target Range (10-12 Hb g/dL) at Least Once During the Study|For correction of anemia, number of participants achieving Hb target range (10-12 g/dL) at least once during the study were reported.|Up to Week 24|ITT population included all the participants who received at least 1 dose of C.E.R.A (Week 0) and for whom data for at least one follow-up variable was available.||Number of participants|||Number
672039|NCT01677767|Primary|Percentage of Participants Achieved Target Range of Hemoglobin|The target range of Hb was 10-12 gram/deciliter (g/dL). Time to achieve target range = (Date of Hb evaluation when participant achieved target Hb range at first time – visit date of first dosing) + 1. The percentage of participants with Hb < 10 g/dL at enrollment, achieving the target range of hemoglobin 10-12 g/dL was reported.|Up to Week 24|ITT population included all the participants who received at least 1 dose of C.E.R.A (Week 0) and for whom data for at least one follow-up variable was available. The analysis population reflects those participants whose Hb value was less than (<) 10 g/dL at enrollment.||Percentage of participants|||Number
672068|NCT01676961|Primary|Percentage of Patients Who Have Responded|Response is defined as platelet increases to greater than 50 x 10^9/L for more than 2 weeks.|8 weeks|Data was not analyzed. Dr. Mazumder left institution and data was not analyzed.|||||
672042|NCT01677767|Primary|Mean Weight of Participants Treated With C.E.R.A|Weight of the participants was measured at the Baseline and summarized with descriptive statistics.|Baseline (Week 0)|The safety population included all participants enrolled into the study. The analysis population reflects those participants whose weights were assessed at baseline.||Kilograms||Standard Deviation|Mean
672043|NCT01677767|Primary|Mean Age of Participants Treated With C.E.R.A|Age was calculated on screening/Baseline visit day by using formula: Age = (Screening visit date – Date of birth)/365.25|Baseline (Week 0)|The safety population included all participants enrolled into the study.||Years||Standard Deviation|Mean
672044|NCT01677624|Secondary|Success Rate for Operability of Embolization|Operability and usability were evaluated by the Investigator on the basis of the sense of resistance when E7040 was injected, and how smoothly the microspheres could pass through the catheter. The evaluation criteria are very easy to use, easy to use, difficult to use, very difficult to use. Success rate was obtained by calculating the percentage of very easy to use and easy to use cases.|Day 1 (embolization) up to Day 30 after treatment|The analysis was performed using Full Analysis Set defined as all participants who received embolization therapy with E7040 and had at least one evaluable efficacy data after the procedure.||percentage of participants||95% Confidence Interval|Number
672045|NCT01677624|Primary|Success Rate of Embolization in the Target Vessel|Embolization performance was graded per 1 of 4 levels: (1) complete embolization, 100% disappearance of contrast enhancement in the target vessel as evaluated by post-embolization digital subtraction angiography; (2) intensive embolization, ≥80% disappearance; (3) moderate embolization, ≥50% and <80% disappearance; (4) mild embolization, <50% disappearance. Success rate was obtained by calculating the percentage of complete embolization and intensive embolization cases. Embolization performance evaluated by both the Imaging Evaluation Committee and by the Investigator or Subinvestigator.|Day 1 (embolization) up to Day 30 after treatment|The analysis was performed using Full Analysis Set defined as all participants who received embolization therapy with E7040 and had at least one evaluable efficacy data after the procedure.||Percentage of participants||95% Confidence Interval|Number
672046|NCT01677507|Secondary|Variation in Episcleral Venous Pressure.|Episcleral venous pressure (mm Hg) of the eye will be determined under baseline condition and under glaucoma drug treatment.|1 week treatment|These measures can be difficult to obtain, so sometimes participants do not tolerate it and some values are missing.||mmHg||Standard Deviation|Mean
672047|NCT01677507|Secondary|Variation in Aqueous Flow Between Individuals.|Aqueous flow production (microliters/minute) will be determined under baseline condition and under glaucoma drug treatment.|1 week after treatment|These measurements can be difficult for participants to tolerate, so sometimes values are missing.||microliters/min||Standard Deviation|Mean
672048|NCT01677507|Primary|Variation in Eye Pressure Between Individuals.|Eye pressure is a steady state quantitative trait that is measured in mm Hg. Eye pressure is determined by the following physiological factors (units of measure): eye fluid or aqueous humor production (microliters/minute), aqueous humor outflow (microliters/minute), outflow resistance (microliters/minute/mm Hg) and venous pressure (mm Hg) of the eye. All of these physiological factors will be determined under baseline condition and under glaucoma drug treatment.|Measurement after 1 week of drug treatment|||mmHg||Standard Deviation|Mean
672049|NCT01677299|Primary|Within Treatment Comparison Based on Ratios of AUCs of PYY||Ratio of Day 5 to Baseline|Evaluable Population||none (values are ratios)||Standard Error|Least Squares Mean
672050|NCT01677299|Primary|Within Treatment Comparison Based on Ratios of AUCs of GLP-1||Ratio of Day 5 to Baseline|Evaluable||none (values are ratios)||Standard Error|Least Squares Mean
672051|NCT01677299|Primary|Change in Fasting Plasma Glucose|LS mean difference from Baseline (Day 1) to Day 5|Change from Baseline (Day 1) to Day 5|Evaluable Population||mg/dL||Standard Error|Least Squares Mean
672052|NCT01677299|Primary|Area Under the Curve (0-t) of Plasma Metformin|Measures from the time of dosing (0 h) to the time of the last quantifiable concentration following dose administration. The dose of study medication was administered at t = -1 min relative to the start time of the standardized breakfast.|Time points at which data were collected to create the area under the curve (0-t) for plasma metformin were: t = -0.08, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, and 11 h relative to the start time of the standardized breakfast.|Evaluable Population||ng*h/mL||Standard Deviation|Mean
672053|NCT01677286|Primary|Amyloid Nephropathy: Proteinuria|Patients with predominant amyloid kidney involvement at enrollment.|Data were assessed at baseline, 6 and 12 months, with change at end of study reported|Analysis is limited to the patients with predominant amyloid kidney involvement at enrollment. Mixed models analyses of change from baseline levels of creatinine clearance (ml/min) and proteinuria (g/day) were performed to include all data collected at baseline, 6 and 12 months.||g/day||Standard Deviation|Mean
672054|NCT01677286|Primary|Amyloid Nephropathy: Creatinine Clearance|Creatinine clearance (ml/min) and proteinuria (g/day) were assessed at baseline, 6 and 12 months, with change at change at end of study reported|12 months|Analysis is limited to the patients with predominant amyloid kidney involvement at enrollment. Mixed models analyses of change from baseline levels of creatinine clearance (ml/min) and proteinuria (g/day) were performed to include all collected data.||ml/min||Standard Deviation|Mean
672055|NCT01677286|Primary|Amyloid Cardiomyopathy: Troponin I|Cardiac biomarkers (BNP, Troponin I) were assessed at baseline, 6 and 12 months, with change at change at end of study reported|12 months|Patients with predominant amyloid involvement of the heart.||ng/mL||Standard Deviation|Mean
672056|NCT01677286|Primary|Amyloid Cardiomyopathy: BNP|Cardiac biomarkers (BNP, Troponin I) were assessed at baseline, 6 and 12 months, with change at end of study reported|12 months|Analysis is limited to the patients with predominant amyloid heart involvement at enrollment. Mixed models analyses of change from baseline levels of cardiac biomarkers (BNP, Troponin I) were performed to include all collected data.||pg/mL||Standard Deviation|Mean
672057|NCT01677195|Primary|AFB1-lysine Adduct (pg/mg) Overtime|After randomization, participants provided serum samples at baseline, weeks 4, 12, and 16. Week 16 represents one month off treatment.|3 months on intervention (weeks 0-12); 1 month off intervention (week 16)|||pg/mg albumin||Standard Deviation|Mean
672069|NCT01676896|Other Pre-specified|Lung Inflammation, Time 3|Exhaled breath condensation collected and sent for lab analysis of NO3. Data collected at Time 3 visit. Higher values represent greater airway inflammation.|Time 3 at 9 months|||uM||Standard Deviation|Mean
672162|NCT01675453|Secondary|Pulmonary Oxygenation|Index of arterial oxygenation efficiency (PaO2/FiO2), alveolar-arterial oxygen tension difference (AaDO2) will be used to assess this outcome measure.|24 hours||||||
672058|NCT01677182|Secondary|Percentage of Participants With MADRS Remission|MADRS remission is defined as a MADRS total score less than or equal to (<=) 10. The MADRS is a clinician rated, validated and widely used scale to measure overall severity of depressive symptoms. It consists of 10-item rated from 0 (normal) to 6 (most abnormal) with a total score range from 0 to 60, where higher scores indicate greater severity of symptoms.|Week 6|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had a baseline value and at least 1 valid post-baseline value for assessment of primary efficacy. LOCF method was used to impute missing data.||percentage of participants|||Number
672059|NCT01677182|Secondary|Percentage of Participants With MADRS Response|MADRS response is defined as greater than or equal to (>=) 50 percent (%) decrease in the MADRS total score from baseline. The MADRS is a clinician rated, validated and widely used scale to measure overall severity of depressive symptoms. It consists of 10-item rated from 0 (normal) to 6 (most abnormal) with a total score range from 0 to 60, where higher scores indicate greater severity of symptoms.|Week 6|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had a baseline value and at least 1 valid post-baseline value for assessment of primary efficacy. Last observation carried forward (LOCF) method was used to impute missing data.||percentage of participants|||Number
672060|NCT01677182|Secondary|Change From Baseline in Quality of Life, Enjoyment, and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) Total Score at Week 6|Q-LES-Q-SF is a self-administered, widely used 16-item questionnaire to assess the degree of enjoyment and satisfaction experienced by participants in various areas of daily functioning, such as social relationships, living/housing, physical health, medication, and global satisfaction. The questionnaire consists of 16 items rated by the participants on a 5-point scale. Of these, 14 items are summed to produce a total quality of life score with a maximum of 70 points. In addition, there are 2 global items that are scored individually. These items rate satisfaction with study medication and overall life satisfaction. The questionnaire is usually scored as a percent of the total possible score, with higher scores indicating better health status.|Baseline and Week 6|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had a baseline value and at least 1 valid post-baseline value for assessment of primary efficacy.||percentage of total possible score||Standard Error|Least Squares Mean
672061|NCT01677182|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 6|The SDS is a 3-item rating scale to assess functional impairment (panic, anxiety, phobic and depressive symptoms) over 3 inter-related domains (work/school, social life, and family life/home responsibilities) rated on an 11-point scale from 0 (not at all) to 10 (extremely) with a total score range from 0 to 30 where higher scores indicates greater severity of impairment.|Baseline and Week 6|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had a baseline value and at least 1 valid post-baseline value for assessment of primary efficacy.||units on a scale||Standard Error|Least Squares Mean
672062|NCT01677182|Secondary|Change From Baseline in the Quick Inventory of Depressive Symptomatology - Self-Rated16 (QIDS-SR16) Total Score at Week 6|The 16-item QIDS-SR16 version is a widely used validated scale designed to assess the severity of depressive symptoms. The participant was asked to rate the severity and frequency of specific symptoms present over the last 7 days. The QIDS-SR16 total scores range from 0 to 27, where higher scores indicate higher severity of symptoms.|Baseline and Week 6|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had a baseline value and at least 1 valid post-baseline value for assessment of primary efficacy.||units on a scale||Standard Error|Least Squares Mean
672063|NCT01677182|Secondary|Change From Baseline in Clinical Global Impression Scale-Severity (CGI-S) to Week 6|"The CGI-S assesses the clinician’s impression of the participant’s current state of mental illness and consists of 1 question for the investigator: Considering your total clinical experience with this particular population, how mentally ill is the patient at this time? which is rated on a 7-point scale (1=normal, not ill at all; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill)."|Baseline and Week 6|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had a baseline value and at least 1 valid post-baseline value for assessment of primary efficacy.||units on a scale||Standard Error|Least Squares Mean
672064|NCT01677182|Secondary|Clinical Global Impression Scale-Improvement (CGI-I) Score|The CGI-I assesses the clinician’s impression of the participant’s state of mental illness improvement and consists of 1 question for the investigator: “Compared to his condition at the start of the study, how much has this patient changed?” which is rated on a 7-point scale (1=very much improved; 2=much improved; 3=minimally improved; 4=no change relative to baseline; 5=minimally worse; 6= much worse; 7=very much worse). In all cases, the assessment was independent of whether the rater believed the improvement was drug-related or not.|Week 6|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had a baseline value and at least 1 valid post-baseline value for assessment of primary efficacy.||units on a scale||Standard Error|Least Squares Mean
672065|NCT01677182|Secondary|Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Week 6|The YMRS is a 11-item scale to assess manic symptoms. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe), and 7 items are rated on a scale from 0 to 4 with higher scores reflecting greater levels of mania. The YMRS total score is calculated as the sum of the 11 individual item scores and ranges from 0-60.|Baseline and Week 6|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had a baseline value and at least 1 valid post-baseline value for assessment of primary efficacy.||units on a scale||Standard Error|Least Squares Mean
672066|NCT01677182|Primary|Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 6|The MADRS is a clinician rated, validated and widely used scale to measure overall severity of depressive symptoms. It consists of 10-item rated from 0(normal) to 6(most abnormal) with a total score range from 0 to 60. Higher scores indicate greater severity of symptoms.|Baseline and Week 6|Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of double-blind study medication and who had a baseline value and at least 1 valid post-baseline value for assessment of primary efficacy.||units on scale||Standard Error|Least Squares Mean
672067|NCT01676961|Secondary|Percentage of Patients Who Experienced Thrombosis or Marrow Fibrosis||Up to 1.5 years|Patient data was not analyzefd|||||
672072|NCT01676896|Secondary|Medication Adherence, Time 3|Parent report of their child remembering/forgetting to take medications. 4-item scale (forgot to take medicine, was careless in taking medicine, stopped taking medicine due to feeling better, stopped taking medicine due to feeling worse), dichotomous response scale (yes, no), sum of number of yes items. Range 0-4, higher score means worse adherence. Data are collected at Time 3 visit.|Time 3 at 9 months|||number of yes responses||Standard Deviation|Mean
672073|NCT01676896|Secondary|Medication Adherence, Time 2|Parent report of their child remembering/forgetting to take medications. 4-item scale (forgot to take medicine, was careless in taking medicine, stopped taking medicine due to feeling better, stopped taking medicine due to feeling worse), dichotomous response scale (yes, no), sum of number of yes items. Range 0-4, higher score means worse adherence. Data are collected at Time 2 visit.|Time 2 at 5 months|||number of yes responses||Standard Deviation|Mean
672074|NCT01676896|Secondary|Medication Adherence, Time 1|Parent report of their child remembering/forgetting to take medications. 4-item scale (forgot to take medicine, was careless in taking medicine, stopped taking medicine due to feeling better, stopped taking medicine due to feeling worse), dichotomous response scale (yes, no), sum of number of yes items. Range 0-4, higher score means worse adherence. Data are collected at study enrollment, Time 1.|Time 1 at baseline|||number of yes responses||Standard Deviation|Mean
672075|NCT01676896|Secondary|Metered Dose Inhaler Skill, Time 1|Observation score of child's skill in using a placebo metered dose inhaler (a teaching inhaler). Observation data recorded by trained data collectors. 8-item scale listing the steps to perform proper inhalation technique. Number of correct steps are summed. Higher score = better skill in using inhaler. Collected at enrollment visit, Time 1 data visit.|Time 1 at baseline|||number of correct steps||Standard Deviation|Mean
672076|NCT01676896|Secondary|Metered Dose Inhaler Skill, Time 2|Observation score of child's skill in using a placebo metered dose inhaler (a teaching inhaler). Observation data recorded by trained data collectors. 8-item scale listing the steps to perform proper inhalation technique. Number of correct steps are summed. Higher score = better skill in using inhaler. Collected at final, time 2 data visit.|Time 2 at 5 months|||number of correct steps||Standard Deviation|Mean
672077|NCT01676896|Secondary|Metered Dose Inhaler Skill, Time 3|Observation score of child's skill in using a placebo metered dose inhaler (a teaching inhaler). Observation data recorded by trained data collectors. 8-item scale listing the steps to perform proper inhalation technique. Number of correct steps are summed. Higher score = better skill in using inhaler. Collected at time 3 data visit.|Time 3 at 9 months|||number of correct steps||Standard Deviation|Mean
672078|NCT01676896|Secondary|Home Asthma Management, Time 3|Parent report of asthma preventive and treatment activities. Data collected at third time point (Time 3). Home Asthma Management scale, asthma preventive and asthma treatment behaviors performed by parent, response scale 1-5, scale range 16-70, higher scores = more frequent home asthma management behaviors.|Time 3 at 9 months|||units on a scale||Standard Deviation|Mean
672079|NCT01676896|Secondary|Home Asthma Management, Time 2.|Parent report of asthma preventive and treatment activities. Data collected at the time 2 visit. Home Asthma Management scale, asthma preventive and asthma treatment behaviors performed by parent, response scale 1-5, scale range 16-70, higher scores = more frequent home asthma management behaviors.|Time 2 at 5 months|||units on a scale||Standard Deviation|Mean
672080|NCT01676896|Secondary|Home Asthma Management, Time 1, Baseline|Parent report of asthma preventive and treatment activities. Data are collected at study enrollment, Time 1, baseline visit. Home Asthma Management scale, asthma preventive and asthma treatment behaviors performed by parent, response scale 1-5, scale range 16-70, higher scores = more frequent home asthma management behaviors.|Time 1, baseline|||units on a scale||Standard Deviation|Mean
672081|NCT01676896|Secondary|Asthma Self-management, Time 1, Baseline|Child self-report of asthma preventive and management activities, collected at each of 4 time points. This is the baseline, Time 1 measure. Asthma Inventory for Children, 18-item scale, response scale 1-5, minimum score = 18, maximum score = 65, higher score = more frequent asthma self management behaviors.|Time 1, baseline|||units on a scale||Standard Deviation|Mean
672082|NCT01676896|Secondary|Asthma Self-management, Time 2|Child self-report of asthma preventive and management activities, collected at each of 4 time points. This is the Time 2 measure. Asthma Inventory for Children, 18-item scale, response scale 1-5, minimum score = 18, maximum score = 65, higher score = more frequent asthma self management behaviors.|Time 2 at 5 months|||units on a scale||Standard Deviation|Mean
672083|NCT01676896|Secondary|Asthma Self-management, Time 3|Child self-report of asthma preventive and management activities, collected at each of 4 time points. This is the Time 3 measure. Asthma Inventory for Children, 18-item scale, response scale 1-5, minimum score = 18, maximum score = 65, higher score = more frequent asthma self management behaviors.|Time 3 at 9 months|||units on a scale||Standard Deviation|Mean
672084|NCT01676896|Primary|Quality of Life, Pre-study Year|Self reported asthma-related quality of life. Data were collected at study enrollment (time 1). The Pediatric Asthma Quality of Life scale. Minimum score 23 to maximum score of 115. A higher score indicates worse quality of life. Mean scale scores are computed.|12 months before baseline|||units on a scale||Standard Deviation|Mean
672085|NCT01676896|Primary|Emergency Department Visits, Pre-study Year|Number of visits to Emergency Department for asthma. Data is obtained from parents for the pre-study year for the previous 12 months.|12 months before baseline|||number of visits||Standard Deviation|Mean
672086|NCT01676896|Primary|Number of Asthma Hospital Stays, During Study Year|Number of hospital admissions for asthma. Data were obtained from parent report at the second, third, and fourth data collection point. The number of hospitalizations were summed for a total number at the end of the 12 months.|12 months|||number of hospital stays||Standard Deviation|Mean
672087|NCT01676896|Primary|Number of Days in Hospital for Asthma, Pre-Study Year|Number of days hospitalized for asthma. Data is obtained from parents for the pre-study year for the previous 12 months.|12 months before baseline|||days hospitalized||Standard Deviation|Mean
672088|NCT01676896|Primary|Absenteeism Pre-study Year|(Days absent/days enrolled)x100 = absenteeism. Using data for the 12 months prior to study enrollment as the pre-study year. Data is provided by the participating school districts.|12 months before baseline|Data for days enrolled and days absent for the pre-study year was obtained from the school districts. Two school districts declined to provide the requested information, therefore there was substantial missing data for this variable.||percentage of days enrolled||Standard Deviation|Mean
672091|NCT01676896|Secondary|Medication Adherence, Time 4|Parent report of their child remembering/forgetting to take medications. 4-item scale (forgot to take medicine, was careless in taking medicine, stopped taking medicine due to feeling better, stopped taking medicine due to feeling worse), dichotomous response scale (yes, no), sum of number of yes items. Range 0-4, higher score means worse adherence. Data are collected at final data point, Time 4.|Time 4 at 12 months|||number of yes responses||Standard Deviation|Mean
672092|NCT01676896|Secondary|Metered Dose Inhaler Skill, Time 4|Observation score of child's skill in using a placebo metered dose inhaler (a teaching inhaler). Observation data recorded by trained data collectors. 8-item scale listing the steps to perform proper inhalation technique. Number of correct steps are summed. Higher score = better skill in using inhaler. Collected at final, time 4 data visit.|Time 4 at 12 months|||number of correct steps||Standard Deviation|Mean
672093|NCT01676896|Secondary|Home Asthma Management, Time 4, End of Study|Parent report of asthma preventive and treatment activities. Data collected at final study visit, Time 4. Home Asthma Management scale, asthma preventive and asthma treatment behaviors performed by parent, response scale 1-5, scale range 16-70, higher scores = more frequent home asthma management behaviors.|Time 4 at 12 months|||units on a scale||Standard Deviation|Mean
672094|NCT01676896|Secondary|Asthma Self-management, Time 4|Child self-report of asthma preventive and management activities, collected at each of 4 time points. This is the Time 4, final measure. Asthma Inventory for Children, 18-item scale, response scale 1-5, minimum score = 18, maximum score = 65, higher score = more frequent asthma self management behaviors.|Time 4, at 12 months|||units on a scale||Standard Deviation|Mean
672095|NCT01676896|Primary|Emergency Department Visits, Study Year|Number of visits to Emergency Department for asthma. Data is obtained from parents at three time points (time 2, 3, and 4) and summed for total number of visits to the emergency department for asthma during the study year.|12 months|||number of visits||Standard Deviation|Mean
672096|NCT01676896|Primary|Number of Days Hospitalized, During Study Year|Number of days hospitalized for asthma. Data were obtained from parent report at the second, third, and fourth data collection point. The number of hospitalization days were summed for a total number at the end of the 12 months.|12 months|||days hospitalized||Standard Deviation|Mean
672097|NCT01676896|Primary|Quality of Life, End of Study|Self reported asthma-related quality of life. Outcome data were collected at end of study (Time 4). The Pediatric Asthma Quality of Life scale. Minimum score 23 to maximum score of 115. A higher score indicates worse quality of life. Mean scale scores are computed.|12 months|||units on a scale||Standard Deviation|Mean
672098|NCT01676896|Primary|Absenteeism, End of Study|(Days absent/days enrolled)x100 = absenteeism. Using data provided by the school district at the end of the study year.|12 months|Data for days enrolled and days absent was obtained from the school districts. Two school districts declined to provide the requested information, therefore there was substantial missing data for this variable.||percentage of days enrolled||Standard Deviation|Mean
672099|NCT01676714|Secondary|Number of Patients Who Experienced Treatment Related Toxicities|Toxicities will be summarized by the type, severity (by NCI CTCAE), time of onset, duration, and outcome. Toxicity will be graded according to the NCI CTCAE version 4.0.|Starting at screening and then at every visit and then up to 30 days after the last dose of study treatment.|||Participants|||Count of Participants
672100|NCT01676714|Secondary|Progression Free Survival|The length of time during and after the treatment of the cancer that a patient lives with the disease but it does not get worse. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|From start of treatment until the date of death from any cause, assessed up to 100 months|||months||Full Range|Median
672101|NCT01676714|Secondary|Disease Control Rate|The total number of patients who demonstrate a response to treatment. Measured by RECIST 1.1 criteria.|From start of treatment, up to 8 weeks|500 mg of dovitinib (5 capsules) once a day for 5 continuous days and stop for 2 days. Continue to take dovitinib capsules in this manner until progression or unacceptable toxicity develops.||participants|||Number
672102|NCT01676714|Primary|Overall Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 100 months|||Participants|||Count of Participants
672103|NCT01676532|Other Pre-specified|Ontario Health Insurance Plan (OHIP)Status|OHIP status of students attending the clinic was not reported or collected|1 year||||||
672104|NCT01676532|Other Pre-specified|Absenteeism|Outcome data comparing absenteeism in the school with the year preceding the SBHC was not collected|1 year||||||
672105|NCT01676532|Other Pre-specified|Follow-up Appointments|Attendance at follow-up appoints was not collected.|1 year||||||
672106|NCT01676532|Other Pre-specified|Number of Students Referred to SBHC Who Attended SBHC|This data was not collected.|8 months||||||
672107|NCT01676532|Other Pre-specified|Number of Students Triaged From School Support Team Meetings|The number of students triaged from SST meetings was not collected.|1 year||||||
672108|NCT01676532|Other Pre-specified|Sprucecourt Public School Vs Other Participating Schools|To compare the number of students who attend the SBHC from the host school (Sprucecourt Public School) with the number of students who attend the SBHC from the other participating schools|8 months|total number of students who attended SBHC||participants|||Number
672109|NCT01676532|Other Pre-specified|Number of Students Enrolled in SBHC Who Were From the Host School (Sprucecourt)|The number of students who enrolled in SBHC who were from the host school Sprucecourt|8 months|Total number of students who enrolled in SBHC. Outcome is the number of students from host school (sprucecourt) who enrolled in SBHC||participants|||Number
672110|NCT01676532|Secondary|Number of Referrals Made of Students Attending SBHC|Number of referrals of the 127 students who attended the SBHC from 8 months-1 year of the opening of the clinic|1 year|||participants|||Number
672111|NCT01676532|Secondary|Number of Students Attending SBHC With New Diagnoses|Number of students attending SBHC with new diagnoses|1 year|120 of the 127 students who attended the SBHC had a new diagnosis. 94 received one new diagnosis and 26 children received more than one new diagnosis||participants|||Number
672113|NCT01676532|Primary|Number of Enrolled Participants Who Attended SBHC|"The primary objectives are to determine utilization of the SBHC including:
The number of students who are enrolled at the SBHC
The number of enrolled students enrolled who attended the SBHC"|1 year|379 students enrolled in the SBHC and 127 of those students attended SBHC. Existing data is based on 127 students who attended SBHC.||participants|||Number
672114|NCT01676415|Secondary|Medication Side-effect and Compliance Inventory|The medication side-effect and compliance inventory is a questionnaire to evaluate the frequency and severity of common side effects associated with the medications used in this study.|4-6 weeks and 3 months after initiation of treatment|Study had difficult accruing sufficient numbers of patients. Additional Institutional Review Board mandated testing for potential participants made study flow challenging. Study was closed for failure to accrue sufficient patients.||Participants|||Count of Participants
672115|NCT01676415|Secondary|Taskforce Symptom Inventory|Change from baseline in individual symptom severity. The taskforce symptom inventory is a visual analog scale of the severity of the 4 major symptoms making up the clinical diagnostic criteria of CRS.|4-6 weeks and 3 months after initiation of treatment|Study had difficult accruing sufficient numbers of patients. Additional Institutional Review Board mandated testing for potential participants made study flow challenging. Study was closed for failure to accrue sufficient patients.||Participants|||Count of Participants
672116|NCT01676415|Secondary|Lund-McKay Score From CT Scan|Change from baseline in Lund-McKay scores from sinus CT-scans at 4-6 weeks and 3 months after initiation of treatment will be used to calculate the overall level of inflammation within the paranasal sinuses.|4-6 weeks and 3 months after initiation of treatment|Only a few of the patients were able to return for the follow up CT scan, therefore this measure was not analyzed.|||||
672117|NCT01676415|Primary|SNOT-22 Questionnaire|"The Sino-nasal Outcome Test-22 is a validated questionnaire that measures 22 nasal and quality of life symptoms (“nasal obstruction” and “loss of smell and taste”) ranked from 0 (not a problem) to 5 (problem as bad as it can be).
Min score= 0, Max score= 110 (worst possible problem on all symptoms)
Change from baseline of the SNOT-22 score. The SNOT-22 questionnaire is a 22-item disease-specific health related quality of life instrument validated for use in chronic rhinosinusitis."|4-6 weeks and 3 months after initiation of treatment|||units on a scale||Standard Error|Mean
672118|NCT01676298|Primary|Percentage of Correct Calls to Assess Reproducibility of the Spartan FRX CYP2C19 System.|"Reproducibility was calculated as a percentage of the correct calls over the total calls made for each genotype group. All calls were made using the Spartan FRX CYP2C19 genotyping diagnostic system.
All data analyses was qualitative, based on the genotype calls determined by the FRX system (using on-board automated data analysis). A printed result listing the genotype call for each SNP was generated by the FRX system at the end of each run. If the result of a test is Inconclusive for one or more SNPs, the test were immediately repeated for the corresponding SNP(s) only, per the instructions for use. Results are reported based on both first-pass and second-pass (i.e. repeated test). For both the first-pass and second-pass results, 1-sided 95% confidence lower limits were calculated using the score method for the % correct calls (i.e. % agreement)."|After second pass result is complete (~3h)|||Percentage of Correct Calls|Participants|95% Confidence Interval|Number
672119|NCT01676220|Secondary|Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline up to Month 12|Hypoglycemia events were Severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); Documented symptomatic hypoglycemia (typical symptoms of hypoglycemia with plasma glucose level of <=3.9 mmol/L [70 mg/dL]); Asymptomatic hypoglycemia (no typical symptoms of hypoglycemia but plasma glucose level <=3.9 mmol/L); Probable symptomatic hypoglycemia (an event during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination, but was presumably caused by a plasma glucose level <=3.9 mmol/L, symptoms treated with oral carbohydrate without a test of plasma glucose); Relative hypoglycemia (an event during which the person with diabetes reported any of the typical symptoms of hypoglycemia, and interpreted the symptoms as indicative of hypoglycemia, but plasma glucose level >3.9 mmol/L); Severe and/or confirmed a hypoglycemia (plasma glucose <=3.9 mmol/L).|Up to 12 months|Safety population: all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. In the event of participants having received treatments different from those assigned according to the randomization schedule, safety analyses were conducted according to treatment received.||percentage of participants|||Number
672120|NCT01676220|Secondary|Change in Total Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint|DTSQ is a validated measure to assess how satisfied participants with diabetes are with their treatment and how they perceive hyper- and hypoglycemia. It consists of 8 questions which are answered on a Likert scale from 0 to 6. DTSQ treatment satisfaction score is the sum of question 1 and 4-8 scores and ranges between 0 and 36, where higher scores indicate more treatment satisfaction. Only DTSQ total score measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.|Baseline, Month 6|mITT Population. Number of participants analyzed = participants included in the mITT population with Baseline and at least one post-baseline DTSQ assessment (Week 12 and/or Month 6).||units on a scale||Standard Error|Least Squares Mean
672121|NCT01676220|Secondary|Change in Daily Basal Insulin Dose From Baseline to Month 6|Only insulin dose measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit.|Baseline, Month 6|mITT Population. Number of participants analyzed = participants included in the mITT population with Baseline and Month 6 basal insulin dose assessment.||U/kg||Standard Deviation|Mean
672122|NCT01676220|Secondary|Change in Variability of 24 Hour Average 8-point SMPG Profiles From Baseline to Month 6 Endpoint|Variability is assessed by the mean of coefficient of variation calculated as 100 multiplied by (standard deviation/mean) over at least 5 measurements of the 8-point profiles. Only variability of 24-hour 8-point SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.|Baseline, Month 6|mITT Population. Number of participants analyzed = participants included in the mITT population with baseline and at least one post-baseline variability of 24-hour average 8-point SMPG assessment (Week 2, Week 4, Week 8, Week 12, Month 4 and/or Month 6).||percentage of mean||Standard Error|Least Squares Mean
672123|NCT01676220|Secondary|Change in 24-hour Average 8-point SMPG Profile From Baseline to Month 6 Endpoint|Change in 24-hour average of 8-point SMPG profile. 8-point SMPG was assessed at: 03:00 hours (clock time) at night; before and 2 hours after breakfast; before and 2 hours after lunch; before and 2 hours after dinner; and at bedtime. Only 24-hour average 8-point SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.|Baseline, Month 6|mITT Population. Number of participants analyzed = participants included in the mITT population with baseline and at least one post-baseline 24-hour average 8-point SMPG assessment (Week 2, Week 4, Week 8, Week 12, Month 4 and/or Month 6).||mmol/L||Standard Error|Least Squares Mean
672124|NCT01676220|Secondary|Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6|Change in each time-point of 8-point SMPG profile: 03:00 hours (clock time) at night; before and 2 hours after breakfast; before and 2 hours after lunch; before and 2 hours after dinner; and at bedtime. Only 8-point SMPG profiles measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit.|Baseline, Month 6|mITT Population. Only participants from the mITT population with a value at baseline and at specified timepoint were analyzed (represented by n=X, X in the category titles).||mmol/L||Standard Deviation|Mean
672125|NCT01676220|Secondary|Percentage of Participants With FPG <5.6 mmol/L (100 mg/dL) at Month 6|Only FPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit.|Month 6|mITT Population. Participants without any available FPG assessment at Month 6 were considered as failures (non-responders).||percentage of participants|||Number
672126|NCT01676220|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Month 6 Endpoint|Only FPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.|Baseline, Month 6|mITT Population. Number of participants analyzed = participants included in the mITT population with baseline and at least one post-baseline FPG assessment (Week 12 and/or Month 6).||mmol/L||Standard Error|Least Squares Mean
672127|NCT01676220|Secondary|Percentage of Participants With HbA1c <7% at Month 6|Only HbA1c measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit.|Month 6|mITT Population. Participants without any available Month 6 HbA1C assessment were considered as failures (non-responders).||percentage of participants|||Number
672128|NCT01676220|Secondary|Variability of Preinjection SMPG at Month 6 Endpoint|Pre-injection SMPG was measured within 30 minutes prior to the injection of the study drug. Variability was assessed by the mean of coefficient of variation calculated as 100 multiplied by (standard deviation/mean) over at least 3 SMPG measured during the 7 days preceding the assessment visit. Only preinjection SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.|Month 6|mITT population. Number of participants analyzed = participants included in the mITT Population with at least one pre-injection SMPG variability assessment (Week 2, Week 4, Week 8, Week 12, Month 4 and/or Month 6).||percentage of mean||Standard Error|Least Squares Mean
672129|NCT01676220|Secondary|Change in Preinjection Self-Monitored Plasma Glucose (SMPG) From Baseline to Month 6 Endpoint|Pre-injection SMPG was measured within 30 minutes prior to the injection of the study drug. Except for baseline value average of preinjection SMPG was assessed by the mean of at least 3 SMPG calculated over the 7 days preceding the assessment visit. Only preinjection SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.|Baseline, Month 6|mITT population. Number of participants analyzed = participants included in the mITT population with baseline and at least one pre-injection SMPG assessment (Week 2, Week 4, Week 8, Week 12, Month 4 and/or Month 6)||mmol/L||Standard Error|Least Squares Mean
672130|NCT01676220|Secondary|Percentage of Participants With At Least One Severe and/or Confirmed Nocturnal Hypoglycemia From Start of Week 9 to Month 6|Nocturnal hypoglycemia was hypoglycemia that occurred between 00:00 and 05:59 hours (clock time), regardless the participant was awake or woke up because of the event. Severe hypoglycemia was an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Confirmed hypoglycemia was an event associated with plasma glucose less than or equal to (<=) 3.9 millimoles per liter (mmol/L) (70 milligram per deciliter [mg/dL]). Only nocturnal hypoglycemia occurring before initiation of rescue therapy were considered in the analysis. Week 9 and Month 6 value correspond to the observed value at Week 9 and Month 6 visit respectively.|Week 9 Up to Month 6|Modified intent-to-treat population.||percentage of participants|||Number
672131|NCT01676220|Primary|Change in HbA1c From Baseline to Month 6 Endpoint|Only HbA1c measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.|Baseline, Month 6|Modified Intent-to-Treat (mITT) population:randomized participants who received at least 1 dose, had baseline and at least 1 post-baseline data of any efficacy variable, irrespective of compliance. Number of participants analyzed=participants included in mITT population with baseline and at least 1 post-baseline HbA1c data (Week 12 and/or Month 6).||percentage of hemoglobin||Standard Error|Least Squares Mean
672132|NCT01676012|Secondary|Sensitivity and Specificity of HD Videobronchoscopy|When the sensitivity and specificity of HD videobronchoscopy in either mode in the abovementioned study is in the vicinity of the reported sensitivity and specificity of SAFE3000 dual mode videobronchoscopy we suggest to use the results of this study perform a power analysis. With this information it may then be possible to design a new future study to compare sensitivity for detecting premalignant lesions in a high risk population in a prospective study.|one year||||||
672163|NCT01675453|Primary|Extravascular Lung Water Index|Extravascular lung water index (ELWI; mL/kg) will be used to assess this outcome measure. ELWI was monitored by transcardiopulmonary thermodilution technique with the PiCCO plus system. Extravascular lung water represents the extravascular fluid of the lung tissue. It includes intra-cellular, interstitial and intra-alveolar water (not pleural effusion). It is indexed to “Predicted Body Weight”.|baseline; 5 min after infusion; 5 min after CPB; 30 min after CPB; end of surgery; 2 h, 4 h, 6 h, 12 h after CPB; Postoperative day 1|||mL/kg||Inter-Quartile Range|Median
672133|NCT01676012|Primary|Sensitivity|Investigate sensitivity of HD bronchoscopy, with or without surface enhancement or tone enhancement in comparison to AFB (the 'gold standard') and standard WLB for detecting abnormalities of the tracheobronchial tree. So we used 5 types of bronchoscopy; SWL (=standard white light), HD (=high defenition bronchoscopy without surface/tone enhancement), HD-i-Scan1 (=high defention bronchoscopy with surface enhancement), HD-i-scan 2 (=high defenition bronchoscopy with tone enhancement), AFB (=autofluorescence bronchoscopy). Furthermore we aim to investigate determination of resection margins of (suspected) malignancies in the glottic and supraglottic area or centrally located lung cancer in comparison to autofluorescence bronchoscopy (SAFE 3000 dual video mode) in a high risk population with biopsies from all suspect lesions identified by either technique.|one year|Vascular abnormalities were scored most frequently in HD + i-scan2 bronchoscopy. Sites suspicious for preinvasive lesions were most frequently reported using AFB. Tumors were detected equally by all modalities. The preferred modality was HD bronchoscopy with i-scan.||# vascular sites detected per patient||Standard Error|Mean
672134|NCT01675830|Secondary|Redness, Irritation, and/or Hyperthermia Due to Head Wrap Use|To identify and describe adverse events observed with use of the Thermoregulation Head Wrap.|These will be assessed upon admission to the CICU, and in 6 hour follow up increments until the last assessment at 72 hours.|Number of adverse events observed||adverse events|||Number
672135|NCT01675830|Primary|Head Wrap Feasibility|To describe the feasibility of placing a Thermoregulation Head Wrap on the infant's head from the time the re-warming process begins to the time baby arrives in the Cardiac Intensive Care Unit (CICU) after transfer from the operating room. Likert scale items assessing feasibility of the head wrap will be completed by clinicians upon patient admission to CICU.|<12 hours|Percentage of respondents that agree device is easy to use||percentage of respondents|||Number
672136|NCT01675661|Secondary|Quality of Life|Outcome will also be tested among the subgroup of participants that meet criteria for medication compliance|12 weeks||||||
672137|NCT01675661|Secondary|Effect of Baseline Smoking Status on Cannabis Negative Urine Drug Screens|Outcome was also tested based on whether the participant identified themselves as a tobacco smoker at baseline.|Study weeks 2-13|Intent to treat; all randomized participants||cannabis negative urine tests|||Number
672138|NCT01675661|Secondary|End-of-treatment Cannabis Abstinence, Measured by Negative Cannabinoid Testing for the Last Four Weeks of Treatment.|This outcome evaluates just the last four weeks of treatment. The outcome measure is again number of negative urine tests for cannabinoids during just the last 4 weeks|Study Days 57-84|Intent to treat; all randomized participants included||negative urine drug tests|||Number
672139|NCT01675661|Primary|The Odds of Negative Urine Cannabinoid Tests During Treatment.|The primary outcome is the abstinence rate over the 12 weeks of treatment. Abstinence is based on a weekly urine drug screen confirmed by central laboratory testing and defined as a negative cannabinoid result.|study weeks 2-13|Intent to treat; all participants randomized||cannabis negative urine tests|||Number
672140|NCT01675544|Primary|Mortality|All cause mortality at 1 year|1 year|||participants|||Number
672141|NCT01675544|Primary|Emergency Room Visit or Hospitalization for Acute Decompensated Heart Failure (ADHF)||1 year|||participants|||Number
672142|NCT01675531|Secondary|Patient's Overall Satisfaction|Patient's overall satisfaction was assessed 7 scales from very much worse to very much improved. (Very much worse, much worse, minimally worse, no change, minimally improved, much improved, very much improved)|4weeks|Analysis of ITT population set.||participants|||Number
672143|NCT01675531|Secondary|Physician's Overall Satisfaction|Physician's overall satisfaction was scored 7 scales from Very much worse to Very much improved. (Very much worse, much worse, minimally worse, No change, Minimally improved, much improved, very much improved).|4 weeks|Analysis of ITT population set.||participants|||Number
672144|NCT01675531|Secondary|Mean Change in FACT-GOG/NTX From Visit1(Week 0) to Visit 4(Week 4 Post-treatment).|"Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FAICT-GOG/NTX).
The mean changes in FACT/GOG-NTX total score and each FACT/GOG-NTX subscale score from Visit 1 (Week 0) to Visit 4 (Week 4 post-treatment) were analyzed. Missing data was handled as LOCF(Last Observation Carried Forward Method).
FACT/GOG-NTX total score range was from 0 to 152. The average change score from baseline to visit 4 indicates thay a lower score on the FACT/GOG-NTX means lower quality of life and a greater impact of neurotoxic symptom on the patient’s life."|4 weeks|Analysis of ITT population set.||units on a scale||Standard Deviation|Mean
672145|NCT01675531|Primary|NRS (Numeric Rating Scale)|"Change of pain intensity score via NRS after vist 4 weeks treatment from baseline (week 0).
NRS-Pain scale assessed the severity of a subject's pain of mean pain over the past 24 hours prior to the visit on a scale of 0 (No pain) and 10 (Worst possible pain). Change = mean score at Week4/ET minus mean score at Baseline."|4 weeks|Analysis of ITT population set. Missing data was handled as LOCF(Last Observation Carried Forward Method).||units on a scale||Standard Deviation|Mean
672146|NCT01675492|Secondary|Uncorrected Visual Acuity (UCVA) of 20/40 or Better|85% of eyes will have UCVA of 20/40 or better, as measured using ETDRS logMAR charts at 4 meters|3 Months|||eyes|eyes||Count of Units
672147|NCT01675492|Primary|Line Loss of More Than Two Lines for Best Spectacle Corrected Visual Acuity (BSCVA)|< 5% of eyes will have a loss of > 2 lines of BSCVA at any postoperative visit, as measured using ETDRS logMAR visual acuity charts at 4 meters|3 Months|||eyes|eyes||Count of Units
672148|NCT01675453|Secondary|Chloride Loading|The amount of chloride ions (mmol per patient) which will be infused during the surgery and ICU stay|24 h||||||
672149|NCT01675453|Secondary|Duration of Mechanical Ventilation||24 hours||||||
672150|NCT01675453|Secondary|Blood Loss|Bleeding from chest tubes|24 hours||||||
672151|NCT01675453|Secondary|Rate of Neurological Complications|Delirium, clinically diagnosed stroke, and encephalopathy.|24 hours||||||
672152|NCT01675453|Secondary|Stroke Volume Index||24 hours||||||
672153|NCT01675453|Secondary|Rate of Hyperchloremic Metabolic Acidosis|blood pH, base excess (BE), plasma level of Cl will be used to assess this outcome measure.|24 hours||||||
672154|NCT01675453|Secondary|Rate of Acute Kidney Injury|serum creatinine, serum cystatin C, urine neutrophil gelatinase-associated lipocalin (uNGAL) will be used to asses this outcome measure.|48 hours||||||
672155|NCT01675453|Secondary|Plasma Osmolarity||24 hours||||||
672156|NCT01675453|Secondary|Plasma Na||24 hours||||||
672157|NCT01675453|Secondary|Endothelial Integrity|Serum levels of intercellular adhesion molecule-1 (ICAM-1), E-selectin will be used to assess this outcome measure.|24 hours||||||
672164|NCT01675427|Secondary|Number of Participants With ITPA Genotype rs7270101 by Erythropoietin Use During Prior Treatment and HCV RNA Genotype|Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records. Past medication use was obtained from medical records and/or participant interview at the Study Visit. Participants with a history of erythropoietin use during prior treatment for CHC were recorded as 'yes' for this finding.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.||participants|||Number
672165|NCT01675427|Secondary|Number of Participants With ITPA Genotype rs1127354 by Erythropoietin Use During Prior Treatment and HCV RNA Genotype|Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records. Past medication use was obtained from medical records and/or participant interview at the Study Visit. Participants with a history of erythropoietin use during prior treatment for CHC were recorded as 'yes' for this finding.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.||participants|||Number
672166|NCT01675427|Secondary|Number of Participants With ITPA Genotype rs7270101 by Incidence of Hemoglobin Drop During Prior Treatment and HCV RNA Genotype|Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype and hematology data were obtained from medical records. Participants with a history of a hemoglobin level less than 10 g/dL or a drop of more than 3 g/dL at any time during prior treatment for CHC were recorded as 'yes' for this finding.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.||participants|||Number
672167|NCT01675427|Secondary|Number of Participants With ITPA Genotype rs1127354 by Incidence of Hemoglobin Drop During Prior Treatment and HCV RNA Genotype|Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype and hematology data were obtained from medical records. Participants with a history of a hemoglobin level less than 10 grams per deciliter (g/dL) or a drop of more than 3 g/dL at any time during prior treatment for CHC were recorded as 'yes' for this finding.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.||participants|||Number
672168|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs8099917 by Overall Virological Response Type and HCV RNA Genotype|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and virological response to prior treatment were obtained from medical records. Overall virological response types included SVR, relapse, and breakthrough. SVR was defined as undetectable HCV RNA level at 24 weeks post-treatment, relapse as an undetectable level at end of treatment with a detectable level at the last post-treatment measurement, and breakthrough as an undetectable level at 1 or more treatment measurements with a detectable level at end of treatment. Undetectable viral loads include those below the LLOD for the assay performed, which may vary from site to site. Response categories were mutually exclusive. Participants with detectable HCV RNA level at 12 or more treatment measurements and who did not meet SVR criteria were considered nonresponders, and those with insufficient treatment response data were recorded as 'none of the above.'|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.||participants|||Number
672169|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by Overall Virological Response Type and HCV RNA Genotype|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and virological response to prior treatment were obtained from medical records. Overall virological response types included sustained virological response (SVR), relapse, and breakthrough. SVR was defined as undetectable HCV RNA level at 24 weeks post-treatment, relapse as an undetectable level at end of treatment with a detectable level at the last post-treatment measurement, and breakthrough as an undetectable level at 1 or more treatment measurements with a detectable level at end of treatment. Undetectable viral loads include those below the LLOD for the assay performed, which may vary from site to site. Response categories were mutually exclusive. Participants with detectable HCV RNA level at 12 or more treatment measurements and who did not meet SVR criteria were considered nonresponders, and those with insufficient treatment response data were recorded as 'none of the above.'|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.||participants|||Number
672170|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs8099917 by Type of Virological Response at End of Treatment and HCV RNA Genotype|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and virological response to prior treatment were obtained from medical records. Virological response types at the end of treatment included undetectable and detectable HCV RNA level. Undetectable viral loads include those below the LLOD for the assay performed, which may vary from site to site.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.||participants|||Number
672171|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by Type of Virological Response at End of Treatment and HCV RNA Genotype|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and virological response to prior treatment were obtained from medical records. Virological response types at the end of treatment included undetectable and detectable HCV RNA level. Undetectable viral loads include those below the LLOD for the assay performed, which may vary from site to site.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.||participants|||Number
672172|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs8099917 by Type of Virological Response in the First 12 Weeks of Treatment and HCV RNA Genotype|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and virological response to prior treatment were obtained from medical records. Virological response types within the first 12 weeks of treatment included RVR, cEVR, and pEVR. RVR was defined as an undetectable HCV RNA level within the first 4 weeks, cEVR as an undetectable level within the first 12 weeks, and pEVR as a 2-log drop from Baseline to 12 weeks. Undetectable viral loads include those below the LLOD for the assay performed, which may vary from site to site. Response categories were mutually exclusive, meaning participants could only achieve cEVR/pEVR in the absence of RVR. Participants achieving neither RVR nor cEVR/pEVR were recorded as 'none of the above.'|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.||participants|||Number
672173|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by Type of Virological Response in the First 12 Weeks of Treatment and HCV RNA Genotype|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and virological response to prior treatment were obtained from medical records. Virological response types within the first 12 weeks of treatment included rapid virological response (RVR), complete early virological response (cEVR), and partial early virological response (pEVR). RVR was defined as an undetectable HCV RNA level within the first 4 weeks, cEVR as an undetectable level within the first 12 weeks, and pEVR as a 2-log drop from Baseline to 12 weeks. Undetectable viral loads include those below the lower limit of detection (LLOD) for the assay performed, which may vary from site to site. Response categories were mutually exclusive, meaning participants could only achieve cEVR/pEVR in the absence of RVR. Participants achieving neither RVR nor cEVR/pEVR were recorded as 'none of the above.'|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.||participants|||Number
672174|NCT01675427|Secondary|Number of Participants With ITPA Genotype rs7270101 by HCV RNA Genotype and Country: Treatment-Experienced (Table 2 of 2 [G4, Other, Total])|Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category. The table below (G4, Other, Total) is a continuation of the preceding table; thus, the overall number of participants analyzed reflects the total number analyzed among all genotypes (G1, G2, G3, G4, and Other).||participants|||Number
672175|NCT01675427|Secondary|Number of Participants With ITPA Genotype rs7270101 by HCV RNA Genotype and Country: Treatment-Experienced (Table 1 of 2 [G1, G2, G3])|Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category. The table below (G1, G2, G3) is continued onto the subsequent table; thus, the overall number of participants analyzed reflects the total number analyzed among all genotypes (G1, G2, G3, G4, and Other).||participants|||Number
672176|NCT01675427|Secondary|Number of Participants With ITPA Genotype rs7270101 by HCV RNA Genotype and Country: Treatment-Naive (Table 2 of 2 [G4, Other, Total])|Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category. The table below (G4, Other, Total) is a continuation of the preceding table; thus, the overall number of participants analyzed reflects the total number analyzed among all genotypes (G1, G2, G3, G4, and Other).||participants|||Number
672177|NCT01675427|Secondary|Number of Participants With ITPA Genotype rs7270101 by HCV RNA Genotype and Country: Treatment-Naive (Table 1 of 2 [G1, G2, G3])|Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category. The table below (G1, G2, G3) is continued onto the subsequent table; thus, the overall number of participants analyzed reflects the total number analyzed among all genotypes (G1, G2, G3, G4, and Other).||participants|||Number
672178|NCT01675427|Secondary|Number of Participants With ITPA Genotype rs1127354 by HCV RNA Genotype and Country: Treatment-Experienced (Table 2 of 2 [G4, Other, Total])|Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category. The table below (G4, Other, Total) is a continuation of the preceding table; thus, the overall number of participants analyzed reflects the total number analyzed among all genotypes (G1, G2, G3, G4, and Other).||participants|||Number
672179|NCT01675427|Secondary|Number of Participants With ITPA Genotype rs1127354 by HCV RNA Genotype and Country: Treatment-Experienced (Table 1 of 2 [G1, G2, G3])|Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category. The table below (G1, G2, G3) is continued onto the subsequent table; thus, the overall number of participants analyzed reflects the total number analyzed among all genotypes (G1, G2, G3, G4, and Other).||participants|||Number
672180|NCT01675427|Secondary|Number of Participants With ITPA Genotype rs1127354 by HCV RNA Genotype and Country: Treatment-Naive (Table 2 of 2 [G4, Other, Total])|Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category. The table below (G4, Other, Total) is a continuation of the preceding table; thus, the overall number of participants analyzed reflects the total number analyzed among all genotypes (G1, G2, G3, G4, and Other).||participants|||Number
672181|NCT01675427|Secondary|Number of Participants With ITPA Genotype rs1127354 by HCV RNA Genotype and Country: Treatment-Naive (Table 1 of 2 [G1, G2, G3])|Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category. The table below (G1, G2, G3) is continued onto the subsequent table; thus, the overall number of participants analyzed reflects the total number analyzed among all genotypes (G1, G2, G3, G4, and Other).||participants|||Number
672182|NCT01675427|Secondary|Number of Participants With ITPA Genotype rs7270101 by HCV RNA Genotype and Region: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and geographic region of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.||participants|||Number
672183|NCT01675427|Secondary|Number of Participants With ITPA Genotype rs7270101 by HCV RNA Genotype and Region: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and geographic region of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.||participants|||Number
672184|NCT01675427|Secondary|Number of Participants With ITPA Genotype rs1127354 by HCV RNA Genotype and Region: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and geographic region of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.||participants|||Number
672185|NCT01675427|Secondary|Number of Participants With ITPA Genotype rs1127354 by HCV RNA Genotype and Region: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and geographic region of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.||participants|||Number
672186|NCT01675427|Secondary|Number of Participants With ITPA Genotype rs7270101 by ITPA Genotype rs1127354 Category: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine ITPA genotype.|Study Visit 1|Core Analysis Population (Treatment-Experienced).||participants|||Number
672187|NCT01675427|Secondary|Number of Participants With Inosine Triphosphatase (ITPA) Genotype rs7270101 by ITPA Genotype rs1127354 Category: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine ITPA genotype.|Study Visit 1|Core Analysis Population (Treatment-Naive).||participants|||Number
672188|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by IL28B Genotype rs8099917 Category: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype.|Study Visit 1|Core Analysis Population (Treatment-Experienced).||participants|||Number
672189|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by IL28B Genotype rs8099917 Category: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype.|Study Visit 1|Core Analysis Population (Treatment-Naive).||participants|||Number
672190|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Country: Treatment-Experienced (Table 2 of 2 [G4, Other, Total])|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category. The table below (G4, Other, Total) is a continuation of the preceding table; thus, the overall number of participants analyzed reflects the total number analyzed among all genotypes (G1, G2, G3, G4, and Other).||participants|||Number
672191|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Country: Treatment-Experienced (Table 1 of 2 [G1, G2, G3])|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category. The table below (G1, G2, G3) is continued onto the subsequent table; thus, the overall number of participants analyzed reflects the total number analyzed among all genotypes (G1, G2, G3, G4, and Other).||participants|||Number
672192|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Country: Treatment-Naive (Table 2 of 2 [G4, Other, Total])|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category. The table below (G4, Other, Total) is a continuation of the preceding table; thus, the overall number of participants analyzed reflects the total number analyzed among all genotypes (G1, G2, G3, G4, and Other).||participants|||Number
672193|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Country: Treatment-Naive (Table 1 of 2 [G1, G2, G3])|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category. The table below (G1, G2, G3) is continued onto the subsequent table; thus, the overall number of participants analyzed reflects the total number analyzed among all genotypes (G1, G2, G3, G4, and Other).||participants|||Number
672194|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype and Country: Treatment-Experienced (Table 2 of 2 [G4, Other, Total])|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category. The table below (G4, Other, Total) is a continuation of the preceding table; thus, the overall number of participants analyzed reflects the total number analyzed among all genotypes (G1, G2, G3, G4, and Other).||participants|||Number
672195|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype and Country: Treatment-Experienced (Table 1 of 2 [G1, G2, G3])|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category. The table below (G1, G2, G3) is continued onto the subsequent table; thus, the overall number of participants analyzed reflects the total number analyzed among all genotypes (G1, G2, G3, G4, and Other).||participants|||Number
672231|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records.|Study Visit 1|Core Analysis Population (Treatment-Naive).||participants|||Number
672196|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype and Country: Treatment-Naive (Table 2 of 2 [G4, Other, Total])|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category. The table below (G4, Other, Total) is a continuation of the preceding table; thus, the overall number of participants analyzed reflects the total number analyzed among all genotypes (G1, G2, G3, G4, and Other).||participants|||Number
672197|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype and Country: Treatment-Naive (Table 1 of 2 [G1, G2, G3])|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category. The table below (G1, G2, G3) is continued onto the subsequent table; thus, the overall number of participants analyzed reflects the total number analyzed among all genotypes (G1, G2, G3, G4, and Other).||participants|||Number
672198|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Region: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and geographic region of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.||participants|||Number
672199|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Region: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and geographic region of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.||participants|||Number
672200|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype and Region: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and geographic region of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.||participants|||Number
672201|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype and Region: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and geographic region of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.||participants|||Number
672202|NCT01675427|Secondary|Mean Platelet Count by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Platelet count was obtained from medical records captured prior to treatment, if applicable. Mean platelet count was calculated by averaging the values of all participants within each arm and expressed in 10^9 cells/L.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.||10^9 cells/L||95% Confidence Interval|Mean
672203|NCT01675427|Secondary|Mean Platelet Count by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Platelet count was obtained from medical records captured prior to treatment, if applicable. Mean platelet count was calculated by averaging the values of all participants within each arm and expressed in 10^9 cells/L.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.||10^9 cells/L||95% Confidence Interval|Mean
672204|NCT01675427|Secondary|Mean Platelet Count by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Platelet count was obtained from medical records captured prior to treatment, if applicable. Mean platelet count was calculated by averaging the values of all participants within each arm and expressed in 10^9 cells/L.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.||10^9 cells/L||95% Confidence Interval|Mean
672205|NCT01675427|Secondary|Mean Platelet Count by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Platelet count was obtained from medical records captured prior to treatment, if applicable. Mean platelet count was calculated by averaging the values of all participants within each arm and expressed in 10^9 cells per liter (10^9 cells/L).|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.||10^9 cells/L||95% Confidence Interval|Mean
672206|NCT01675427|Secondary|Mean AST Ratio by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. AST level was obtained from medical records captured prior to treatment, if applicable. Each participant's AST ratio was calculated as AST level divided by the upper limit of normal (40 IU/L for males and 25 IU/L for females). Mean AST ratio was calculated by averaging the values of all participants within each arm.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.||ratio||95% Confidence Interval|Mean
672207|NCT01675427|Secondary|Mean AST Ratio by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. AST level was obtained from medical records captured prior to treatment, if applicable. Each participant's AST ratio was calculated as AST level divided by the upper limit of normal (40 IU/L for males and 25 IU/L for females). Mean AST ratio was calculated by averaging the values of all participants within each arm.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.||ratio||95% Confidence Interval|Mean
672232|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records.|Study Visit 1|Core Analysis Population (Treatment-Experienced).||participants|||Number
672208|NCT01675427|Secondary|Mean AST Ratio by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. AST level was obtained from medical records captured prior to treatment, if applicable. Each participant's AST ratio was calculated as AST level divided by the upper limit of normal (40 IU/L for males and 25 IU/L for females). Mean AST ratio was calculated by averaging the values of all participants within each arm.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.||ratio||95% Confidence Interval|Mean
672209|NCT01675427|Secondary|Mean Aspartate Aminotransferase (AST) Ratio by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. AST level was obtained from medical records captured prior to treatment, if applicable. Each participant's AST ratio was calculated as AST level divided by the upper limit of normal (40 IU/L for males and 25 IU/L for females). Mean AST ratio was calculated by averaging the values of all participants within each arm.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.||ratio||95% Confidence Interval|Mean
672210|NCT01675427|Secondary|Mean ALT Ratio by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. ALT level was obtained from medical records captured prior to treatment, if applicable. Each participant's ALT ratio was calculated as ALT level divided by the upper limit of normal (55 IU/L for males and 30 IU/L for females). Mean ALT ratio was calculated by averaging the values of all participants within each arm.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.||ratio||95% Confidence Interval|Mean
672211|NCT01675427|Secondary|Mean ALT Ratio by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. ALT level was obtained from medical records captured prior to treatment, if applicable. Each participant's ALT ratio was calculated as ALT level divided by the upper limit of normal (55 IU/L for males and 30 IU/L for females). Mean ALT ratio was calculated by averaging the values of all participants within each arm.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.||ratio||95% Confidence Interval|Mean
672212|NCT01675427|Secondary|Mean ALT Ratio by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. ALT level was obtained from medical records captured prior to treatment, if applicable. Each participant's ALT ratio was calculated as ALT level divided by the upper limit of normal (55 IU/L for males and 30 IU/L for females). Mean ALT ratio was calculated by averaging the values of all participants within each arm.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.||ratio||95% Confidence Interval|Mean
672213|NCT01675427|Secondary|Mean Alanine Aminotransferase (ALT) Ratio by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. ALT level was obtained from medical records captured prior to treatment, if applicable. Each participant's ALT ratio was calculated as ALT level divided by the upper limit of normal (55 international units per liter [IU/L] for males and 30 IU/L for females). Mean ALT ratio was calculated by averaging the values of all participants within each arm.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.||ratio||95% Confidence Interval|Mean
672214|NCT01675427|Secondary|Mean HCV RNA Level by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA level was obtained from medical records. Mean HCV RNA level was calculated by averaging the values of all participants within each arm and expressed in log10 IU/mL.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.||log10 IU/mL||95% Confidence Interval|Mean
672215|NCT01675427|Secondary|Mean HCV RNA Level by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA level was obtained from medical records. Mean HCV RNA level was calculated by averaging the values of all participants within each arm and expressed in log10 IU/mL.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.||log10 IU/mL||95% Confidence Interval|Mean
672216|NCT01675427|Primary|Mean FibroScan Values by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver elastography (FibroScan) were obtained from medical records. FibroScan values were based upon previous noninvasive assessment captured prior to treatment, if applicable. Mean FibroScan values were determined by averaging the values of all participants within each arm and expressed in kPa.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.||kPa||95% Confidence Interval|Mean
672217|NCT01675427|Primary|Mean FibroScan Values by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver elastography (FibroScan) were obtained from medical records. FibroScan values were based upon previous noninvasive assessment captured prior to treatment, if applicable. Mean FibroScan values were determined by averaging the values of all participants within each arm and expressed in kPa.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.||kPa||95% Confidence Interval|Mean
672218|NCT01675427|Primary|Mean FibroScan Values by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver elastography (FibroScan) were obtained from medical records. FibroScan values were based upon previous noninvasive assessment captured prior to treatment, if applicable. Mean FibroScan values were determined by averaging the values of all participants within each arm and expressed in kPa.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.||kPa||95% Confidence Interval|Mean
672334|NCT01674621|Primary|BMD (Lumbar Spine)|Change in BMD, using DXA results; active compared to placebo.|6 Months|Modified intent-to-treat population included all patients with pre-treatment and end-of-treatment evaluable DXA assessments. The patients are analyzed as randomized.||Percent change||Standard Deviation|Mean
672219|NCT01675427|Primary|Mean FibroScan Values by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver elastography (FibroScan) were obtained from medical records. FibroScan values were based upon previous noninvasive assessment captured prior to treatment, if applicable. Mean FibroScan values were determined by averaging the values of all participants within each arm and expressed in kilopascals (kPa).|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.||kPa||95% Confidence Interval|Mean
672220|NCT01675427|Primary|Number of Participants With IL28B Genotype rs8099917 by METAVIR Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver fibrosis stage (Stage F0, Stage F1, Stage F2, Stage F3, or Stage F4) were obtained from medical records. Liver fibrosis stage was based upon previous biopsy using the METAVIR scoring system and captured prior to treatment, if applicable.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.||participants|||Number
672221|NCT01675427|Primary|Number of Participants With IL28B Genotype rs8099917 by METAVIR Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver fibrosis stage (Stage F0, Stage F1, Stage F2, Stage F3, or Stage F4) were obtained from medical records. Liver fibrosis stage was based upon previous biopsy using the METAVIR scoring system and captured prior to treatment, if applicable.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.||participants|||Number
672222|NCT01675427|Primary|Number of Participants With IL28B Genotype rs12979860 by METAVIR Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver fibrosis stage (Stage F0, Stage F1, Stage F2, Stage F3, or Stage F4) were obtained from medical records. Liver fibrosis stage was based upon previous biopsy using the METAVIR scoring system and captured prior to treatment, if applicable.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.||participants|||Number
672223|NCT01675427|Primary|Number of Participants With IL28B Genotype rs12979860 by METAVIR Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver fibrosis stage (Stage F0, Stage F1, Stage F2, Stage F3, or Stage F4) were obtained from medical records. Liver fibrosis stage was based upon previous biopsy using the METAVIR scoring system and captured prior to treatment, if applicable.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.||participants|||Number
672224|NCT01675427|Primary|Number of Participants With IL28B Genotype rs8099917 by Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver fibrosis stage ('Cirrhotic,' 'Transition to cirrhosis,' 'Advanced fibrosis noncirrhotic,' 'Mild/minimal fibrosis,' and 'No fibrosis') were obtained from medical records. Liver fibrosis stage was based upon previous biopsy using these five categories and captured prior to treatment, if applicable.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.||participants|||Number
672225|NCT01675427|Primary|Number of Participants With IL28B Genotype rs8099917 by Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver fibrosis stage ('Cirrhotic,' 'Transition to cirrhosis,' 'Advanced fibrosis noncirrhotic,' 'Mild/minimal fibrosis,' and 'No fibrosis') were obtained from medical records. Liver fibrosis stage was based upon previous biopsy using these five categories and captured prior to treatment, if applicable.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.||participants|||Number
672226|NCT01675427|Primary|Number of Participants With IL28B Genotype rs12979860 by Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver fibrosis stage ('Cirrhotic,' 'Transition to cirrhosis,' 'Advanced fibrosis noncirrhotic,' 'Mild/minimal fibrosis,' and 'No fibrosis') were obtained from medical records. Liver fibrosis stage was based upon previous biopsy using these five categories and captured prior to treatment, if applicable.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.||participants|||Number
672227|NCT01675427|Primary|Number of Participants With IL28B Genotype rs12979860 by Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver fibrosis stage ('Cirrhotic,' 'Transition to cirrhosis,' 'Advanced fibrosis noncirrhotic,' 'Mild/minimal fibrosis,' and 'No fibrosis') were obtained from medical records. Liver fibrosis stage was based upon previous biopsy using these five categories and captured prior to treatment, if applicable.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.||participants|||Number
672228|NCT01675427|Secondary|Mean HCV RNA Level by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA level was obtained from medical records. Mean HCV RNA level was calculated by averaging the values of all participants within each arm and expressed in log10 IU/mL.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.||log10 IU/mL||95% Confidence Interval|Mean
672229|NCT01675427|Secondary|Mean HCV RNA Level by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA level was obtained from medical records. Mean HCV RNA level was calculated by averaging the values of all participants within each arm and expressed in log10 international units per milliliter (log10 IU/mL).|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.||log10 IU/mL||95% Confidence Interval|Mean
672230|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records.|Study Visit 1|Core Analysis Population (Treatment-Experienced).||participants|||Number
672233|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records.|Study Visit 1|Core Analysis Population (Treatment-Naive).||participants|||Number
672234|NCT01675427|Secondary|BMI by IL28B Genotype rs8099917: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including height and pre-treatment body weight, were obtained from medical records and/or participant interview at the Study Visit. Each participant's BMI was calculated as weight divided by height-squared, expressed in kg/m^2, and mean BMI was calculated by averaging the values of all participants within each arm.|Study Visit 1|Core Analysis Population (Treatment-Experienced).||kg/m^2||95% Confidence Interval|Mean
672235|NCT01675427|Secondary|BMI by IL28B Genotype rs8099917: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including height and pre-treatment body weight, were obtained from medical records and/or participant interview at the Study Visit. Each participant's BMI was calculated as weight divided by height-squared, expressed in kg/m^2, and mean BMI was calculated by averaging the values of all participants within each arm.|Study Visit 1|Core Analysis Population (Treatment-Naive).||kg/m^2||95% Confidence Interval|Mean
672236|NCT01675427|Secondary|BMI by IL28B Genotype rs12979860: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including height and pre-treatment body weight, were obtained from medical records and/or participant interview at the Study Visit. Each participant's BMI was calculated as weight divided by height-squared, expressed in kg/m^2, and mean BMI was calculated by averaging the values of all participants within each arm.|Study Visit 1|Core Analysis Population (Treatment-Experienced).||kg/m^2||95% Confidence Interval|Mean
672237|NCT01675427|Secondary|Mean Body Mass Index (BMI) by IL28B Genotype rs12979860: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including height and pre-treatment body weight, were obtained from medical records and/or participant interview at the Study Visit. Each participant's BMI was calculated as weight divided by height-squared, expressed in kilograms per meter-squared (kg/m^2), and mean BMI was calculated by averaging the values of all participants within each arm.|Study Visit 1|Core Analysis Population (Treatment-Naive).||kg/m^2||95% Confidence Interval|Mean
672238|NCT01675427|Secondary|Mean Body Weight by IL28B Genotype rs8099917: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including pre-treatment body weight, were obtained from medical records and/or participant interview at the Study Visit. Mean body weight was calculated by averaging the values of all participants within each arm and expressed in kg.|Study Visit 1|Core Analysis Population (Treatment-Experienced).||kg||95% Confidence Interval|Mean
672239|NCT01675427|Secondary|Mean Body Weight by IL28B Genotype rs8099917: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including pre-treatment body weight, were obtained from medical records and/or participant interview at the Study Visit. Mean body weight was calculated by averaging the values of all participants within each arm and expressed in kg.|Study Visit 1|Core Analysis Population (Treatment-Naive).||kg||95% Confidence Interval|Mean
672240|NCT01675427|Secondary|Mean Body Weight by IL28B Genotype rs12979860: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including pre-treatment body weight, were obtained from medical records and/or participant interview at the Study Visit. Mean body weight was calculated by averaging the values of all participants within each arm and expressed in kg.|Study Visit 1|Core Analysis Population (Treatment-Experienced).||kg||95% Confidence Interval|Mean
672241|NCT01675427|Secondary|Mean Body Weight by IL28B Genotype rs12979860: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including pre-treatment body weight, were obtained from medical records and/or participant interview at the Study Visit. Mean body weight was calculated by averaging the values of all participants within each arm and expressed in kilograms (kg).|Study Visit 1|Core Analysis Population (Treatment-Naive).||kg||95% Confidence Interval|Mean
672242|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs8099917 by Ethnic Origin: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including self-reported ethnic origin, were obtained from medical records and/or participant interview at the Study Visit.|Study Visit 1|Core Analysis Population (Treatment-Experienced).||participants|||Number
672243|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs8099917 by Ethnic Origin: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including self-reported ethnic origin, were obtained from medical records and/or participant interview at the Study Visit.|Study Visit 1|Core Analysis Population (Treatment-Naive).||participants|||Number
672244|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by Ethnic Origin: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including self-reported ethnic origin, were obtained from medical records and/or participant interview at the Study Visit.|Study Visit 1|Core Analysis Population (Treatment-Experienced).||participants|||Number
672245|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by Ethnic Origin: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including self-reported ethnic origin, were obtained from medical records and/or participant interview at the Study Visit.|Study Visit 1|Core Analysis Population (Treatment-Naive).||participants|||Number
672246|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs8099917 by Gender: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including gender, were obtained from medical records and/or participant interview at the Study Visit.|Study Visit 1|Core Analysis Population (Treatment-Experienced).||participants|||Number
672247|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs8099917 by Gender: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including gender, were obtained from medical records and/or participant interview at the Study Visit.|Study Visit 1|Core Analysis Population (Treatment-Naive).||participants|||Number
672248|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by Gender: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including gender, were obtained from medical records and/or participant interview at the Study Visit.|Study Visit 1|Core Analysis Population (Treatment-Experienced).||participants|||Number
672249|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by Gender: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including gender, were obtained from medical records and/or participant interview at the Study Visit.|Study Visit 1|Core Analysis Population (Treatment-Naive).||participants|||Number
672250|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs8099917 by METAVIR Liver Inflammation Grade and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver inflammation grade (Grade A0, Grade A1, Grade A2, or Grade A3) were obtained from medical records. Liver inflammation grade was based upon previous biopsy using the METAVIR scoring system and captured prior to treatment, if applicable.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.||participants|||Number
672251|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs8099917 by METAVIR Liver Inflammation Grade and HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver inflammation grade (Grade A0, Grade A1, Grade A2, or Grade A3) were obtained from medical records. Liver inflammation grade was based upon previous biopsy using the METAVIR scoring system and captured prior to treatment, if applicable.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.||participants|||Number
672252|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by METAVIR Liver Inflammation Grade and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver inflammation grade (Grade A0, Grade A1, Grade A2, or Grade A3) were obtained from medical records. Liver inflammation grade was based upon previous biopsy using the METAVIR scoring system and captured prior to treatment, if applicable.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.||participants|||Number
672253|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by METAVIR Liver Inflammation Grade and HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver inflammation grade (Grade A0, Grade A1, Grade A2, or Grade A3) were obtained from medical records. Liver inflammation grade was based upon previous biopsy using the METAVIR scoring system and captured prior to treatment, if applicable.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.||participants|||Number
672254|NCT01675427|Primary|Number of Participants With IL28B Genotype rs8099917 by Cirrhosis Status and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and cirrhosis status were obtained from medical records. Cirrhosis status was based upon previous biopsy or noninvasive assessment captured prior to treatment, if applicable.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.||participants|||Number
672255|NCT01675427|Primary|Number of Participants With IL28B Genotype rs8099917 by Cirrhosis Status and HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and cirrhosis status were obtained from medical records. Cirrhosis status was based upon previous biopsy or noninvasive assessment captured prior to treatment, if applicable.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.||participants|||Number
672256|NCT01675427|Primary|Number of Participants With IL28B Genotype rs12979860 by Cirrhosis Status and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and cirrhosis status were obtained from medical records. Cirrhosis status was based upon previous biopsy or noninvasive assessment captured prior to treatment, if applicable.|Study Visit 1|Core Analysis Population (Treatment-Experienced): Only participants who had received prior treatment for CHC were included in the analysis; n = number of participants analyzed within each HCV RNA genotype category.||participants|||Number
672257|NCT01675427|Primary|Number of Participants With Interleukin 28B (IL28B) Genotype rs12979860 by Cirrhosis Status and Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype (Genotype 1 [G1], Genotype 2 [G2], Genotype 3 [G3], Genotype 4 [G4], and all other genotypes [Other]) and cirrhosis status ('Cirrhosis/transition to cirrhosis' or 'No cirrhosis') were obtained from medical records. Cirrhosis status was based upon previous biopsy or noninvasive assessment captured prior to treatment, if applicable.|Study Visit 1 (single study visit)|Core Analysis Population (Treatment-Naive): Only participants who had not received prior treatment for CHC were included in the analysis; n = number of participants analyzed within each HCV RNA genotype category.||participants|||Number
672258|NCT01675167|Secondary|Medical Outcomes Score Sleep Subscale - Quantity of Sleep/Optimal Sleep|Medical Outcomes Score (MOS) Sleep scale uses 12 items to measure 6 dimensions of sleep (sleep disturbance, somnolence, sleep adequacy, snoring, awaken short of breath or headache, and quantity of sleep/optimal sleep) and an overall sleep problems index score. The quantity of sleep dimension is the average number of hours of sleep per night reported and optimal sleep is when the number of hours of sleep is ≥7.|Week 12|Analysis based on PRO population; randomized subjects who received at least 1 dose of double-blind study medication and had at least 1 post-dose assessment on PRO measures. Subjects from 1 site are excluded from the population (19). Includes only participants with MOS assessment at week 12 (n=231 buprenorphine and n=230 placebo).||participants|||Number
672328|NCT01674634|Secondary|Clinical Success|Clinical success is defined as reduction of FFC of a treated joint to within 0-5 degrees of normal within 30 days of injection|Within 30 days|Efficacy analysis was based on the mITT population; all enrolled subjects who received both AA4500 injections and had a post-injection efficacy measure. Ten subjects were granted special re-enrollment and had an additional joint pair treated on the contralateral hand. This assessment is based on individual treated joints by joint type.||Joints|Treated Joints||Number
672259|NCT01675167|Secondary|Change From Baseline to Week 12 in Medical Outcome Score Sleep Subscale|Medical Outcomes Score (MOS) Sleep Scale uses 12 items to measure 6 dimensions of sleep (sleep disturbance, somnolence, sleep adequacy, snoring, awaken short of breath or headache, and quantity of sleep/optimal sleep) and an overall sleep problems index score. The scores of the dimensions (except quantity of sleep/optimal sleep) and of the sleep problem index range on a 0 to 100 scale, with higher scores reflecting more of the attribute implied by the name (eg, greater sleep disturbance, greater adequacy of sleep).|Baseline, Week 12|Analysis based on PRO population; randomized subjects who received at least 1 dose of double-blind study medication and had at least 1 post-dose assessment on PRO measures. Subjects from 1 site are excluded from the population (19). Includes only participants with MOS assessment at week 12 (n=231 buprenorphine and n=230 placebo).||units on a scale||Standard Deviation|Mean
672260|NCT01675167|Secondary|Change From Baseline to Week 12 in Roland Morris Disability Questionnaire|Subjects assess disability due to back pain using the Roland Morris Disability Questionnaire (RMDQ) consisting of 24 statements of disability. The score of the RMDQ is the total number of items checked, ranging from 0 to 24 with higher scores indicating greater disability.|Baseline, week 12|Analysis based on PRO population; randomized subjects who received at least 1 dose of double-blind study medication and had at least 1 post-dose assessment on PRO measures. Subjects from 1 site are excluded from the population (19). Includes only participants with RMDQ assessment at week 12 (n=225 buprenorphine and n=231 placebo).||units on a scale||Standard Deviation|Mean
672261|NCT01675167|Secondary|Patient Global Impression of Change|Subjects assessed their change in activity limitations as they relate to their painful condition since beginning treatment using the Patient Global Impression of Change (PGIC) questionnaire, a 7-point scale ranging from 1 (no change [or condition has got worse]) to 7 (a great deal better, and a considerable improvement that made all the difference)|Week 12|Analysis based on Patient-Reported Outcomes (PRO) population; randomized subjects who received at least 1 dose of double-blind medication and had at least 1 post-dose assessment on PRO measures. Subjects from 1 site excluded from population (19). Includes only participants with PGIC assessment at week 12 (n=231 buprenorphine and n=230 placebo).||units on a scale||Standard Deviation|Mean
672262|NCT01675167|Secondary|Percentage of Participants With Treatment Failure in the Double-blind Treatment Phase (up to 12 Weeks)|Treatment failure is defined as study discontinuation due to lack of efficacy or discontinuation due to adverse events in the double-blind treatment phase.|Baseline to treatment failure or end of double-blind treatment phase (up to 12 weeks)|Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication. One (1) subject did not receive double-blind study medication and an additional 19 subjects from 1 site were excluded from the population.||percentage of participants|||Number
672263|NCT01675167|Secondary|Time to Optimal Dose of Open-label Study Medication|"Overall time to reach the optimum dose of study medication required to progress to double-blind treatment"|Up to 8 weeks in open-label titration|Analysis based on randomized subjects in the Safety population; all subjects who received at least 1 dose of study medication and were randomized into double-blind treatment||days||Standard Deviation|Mean
672264|NCT01675167|Secondary|Number of Subjects With Opioid Rescue Medication Use|Use of analgesic rescue medication recorded in subject diary|Week 1 to Week 12|Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication. One (1) subject did not receive double-blind study medication and an additional 19 subjects from 1 site were excluded from the population.||participants|||Number
672265|NCT01675167|Secondary|Number of Participants With Response to Treatment (Responder) Using NRS Scale|Responders are subjects who achieve a relative reduction in pain intensity from the start of open-label titration to week 12 in double-blind treatment. Average pain intensity over the last 24 hours was rated on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).|Prior to open-label titration to week 12 in double-blind treatment|Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication. One (1) subject did not receive double-blind study medication and an additional 19 subjects from 1 site were excluded from the population.||participants|||Number
672266|NCT01675167|Primary|Change From Baseline to Week 12 in Average Daily Pain Intensity Scores|Change in pain intensity = average of daily pain scores from the last 7 days prior to week 12 visit - average of daily pain scores for the last 7 days prior to randomization. Average pain intensity over the last 24 hours was rated on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).|Baseline, week 12|Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication. One (1) subject did not receive double-blind study medication and an additional 19 subjects from 1 site were excluded from the population.||units on a scale||Standard Deviation|Mean
672267|NCT01675141|Secondary|Expression of Cereblon (CRBN) and How it Relates to Natural Killer (NK) Cell Number and Activity|Relative fold change in CRBN and correlation (R2) to NK cell number and activity.|participants were followed for the duration of their treatment, an average of 2 years|This outcome was not done because this study was closed prior to full enrollment. Given study closure, the primary endpoint could not be and was not evaluated. There was not an adequate amount of specimens collected to arrive to any analyses conclusions.|||||
672268|NCT01675141|Secondary|Changes in B Cell Subsets, Myeloid Derived Suppressor Cells and T Regulatory Cells by Phenotypic Analysis During the Course of Therapy|Percent change in total number of B Cell Subsets, Myeloid Derived Suppressor Cells and T Regulatory Cells by Phenotypic Analysis During the Course of Therapy|participants were followed for the duration of their treatment, an average of 2 years|This outcome was not done because this study was closed prior to full enrollment. Given study closure, the primary endpoint could not be and was not evaluated. There was not an adequate amount of specimens collected to arrive to any analyses conclusions.|||||
672269|NCT01675141|Secondary|Natural Killer (NK) Cell Function and Activity|Percent of target cell lysis by NK cells|participants were followed for the duration of their treatment, an average of 2 years|This outcome was not done because this study was closed prior to full enrollment. Given study closure, the primary endpoint could not be and was not evaluated. There was not an adequate amount of specimens collected to arrive to any analyses conclusions.|||||
672332|NCT01674621|Secondary|Serum Markers of Bone Formation and Resorption|Change in laboratory results; active compared to placebo.|6 months|Modified intent-to-treat population included all patients with pre-treatment and end-of-treatment evaluable DXA assessments. The patients are analyzed as randomized.||Percent change||Standard Deviation|Mean
672270|NCT01675141|Secondary|Progression Free Survival (PFS)|PFS is defined as the time from study entry until progression or death. Progression is assessed by the International Myeloma Workshop Consensus Panel Criteria. Progressive disease requires any one or more of the following: increase of ≥25% from baseline or lowest response value in Serum M component, Urine M component, free light chain or bone marrow plasma cell percentage. Lowest response value does not need to be a confirmed value. Serum M-component absolute increase must be ≥0.5 g/dl. The serum M-component increases of ≥1 gm/dl are sufficient to define relapse if starting M-component is ≥5 g/dl. Urine M-component absolute increase must be ≥200mg/24h. Only in patients without measureable serum and urine M-protein levels: the absolute increase in difference between involved and uninvolved free light chain levels must be >10mg/dl.|participants were followed for the duration of their treatment, an average of 2 years|||months||95% Confidence Interval|Median
672271|NCT01675141|Secondary|Duration of Response|Duration of response is defined as time from response to disease progression or death. Progression is assessed by the International Myeloma Workshop Consensus Panel Criteria. Progressive disease requires any one or more of the following: increase of ≥25% from baseline or lowest response value in Serum M component, Urine M component, free light chain or bone marrow plasma cell percentage. Lowest response value does not need to be a confirmed value. Serum M-component absolute increase must be ≥0.5 g/dl. The serum M-component increases of ≥1 gm/dl are sufficient to define relapse if starting M-component is ≥5 g/dl. Urine M-component absolute increase must be ≥200mg/24h. Only in patients without measureable serum and urine M-protein levels: the absolute increase in difference between involved and uninvolved free light chain levels must be >10mg/dl.|participants were followed for the duration of their treatment, an average of 2 years|||Months||95% Confidence Interval|Median
672272|NCT01675141|Secondary|Number of Participants With Serious and Non-serious Adverse Events|Here is the number of serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|37 months and 12 days|||Participants|||Count of Participants
672273|NCT01675141|Primary|Longitudinal Assessment of T Cell (Cluster of Differentiation 4 (CD4), Cluster of Differentiation 8 (CD8), Natural Killer T-cell (NKT) and Natural Killer (NK) Cell Counts|Peripheral blood samples will be collected to assess T cell (CD4, CD8), NKT and NK cell counts using flow cytometry.|participatns were followed for the duration of their treatment, an average of 2 years|This outcome was not done because this study was closed prior to full enrollment. Given study closure, the primary endpoint could not be and was not evaluated. There was not an adequate amount of specimens collected to arrive to any analyses conclusions.|||||
672274|NCT01675128|Secondary|Number of Participants With a Decrease in elF4E mRNA Expression in Peripheral Blood|Peripheral blood analysis of elF4E mRNA expression was performed using real time quantitative polymerase chain reaction (q-PCR) to assess the downstream effect and determine if proteins are being manufactured. The number of participants with a decrease (criteria unavailable) in elF4E determines if the drug is working. Cell proliferation or reduction was evaluated by a pathologist.|2 weeks|Per protocol, this outcome measure was assessed in the phase II portion only because all participants were getting the same dose.||participants|||Number
672275|NCT01675128|Secondary|Number of Participants With a Reduced Effect of elF4E Inhibition on Relevant Regulated Proteins|Protein levels in the biopsy sample was assessed by immunohistochemistry using anti-oligonucleotide antibody to assess the downstream effect and determine if proteins are being manufactured. The number of participants with a reduced effect (criteria unavailable) of elF4E inhibition on relevant regulated proteins determines if the drug is working.|2 weeks|Per protocol, this outcome measure was assessed in the phase II portion only because all participants were getting the same dose.||participants|||Number
672276|NCT01675128|Secondary|Number of Participants With Intracellular and Stromal Presence of ISIS in Tumor Tissue|Intracellular and stromal presence of ISIS in tumor tissue was assessed by immunohistochemistry (IHC) and Crystal Violet staining to determine effectiveness of drug. Tissue that retains stain indicates intracellular and stromal presence of ISIS and determines if the drug is working. Relative staining intensity (intensity criteria unavailable) was evaluated by a pathologist.|2 weeks|Per protocol, this outcome measure was assessed in the phase II portion only because all participants were getting the same dose.||participants|||Number
672277|NCT01675128|Secondary|AUC(ALL) (Area Under the Plasma Concentration vs. Time Curve for All Time Points)|AUC(ALL) (Area under the plasma concentration vs. time curve for all time points) was assessed for CPT-11 (irinotecan), its active metabolite SN38, and the glucuronic acid metabolite of SN38, SN38-G to derive the total AUC(ALL).|up to 24 hours post end of infusion|Phase I Dose Level I and Phase I Dose Level II were grouped together for this outcome measure. Complete pharmacokinetic data for only ten of the fourteen participants enrolled on the phase I portion of the study were available for analysis. Data is unavailable to report each individual time point.||hr*ng/mL||Standard Deviation|Mean
672278|NCT01675128|Secondary|Overall Survival|Overall survival is defined as the time from the on study date until the date of death or date last known alive.|≥ 12 months|Only 6/10 participants in Phase I, Dose Level II and 9/10 participants in Phase II were evaluable. Per protocol, overall survival was not to be reported for the Phase I Dose Level I Arm because the participants have different histologies, thus overall survival data for Phase I Dose Level I.||participants|||Number
672279|NCT01675128|Secondary|Number of Participants With Progression Free Survival|Progression free survival is defined as the time beginning on the on study date and continuing until date of progression or date removed from study for an adverse event.|≤ 6 months|Only 6/10 participants in Phase I, Dose Level II and 9/10 participants in Phase II were evaluable. Per protocol, progression free survival was not to be reported for the Phase I Dose Level I Arm because the participants have different histologies, thus there is no progression free survival data for Phase I Dose Level I.||participants|||Number
672333|NCT01674621|Secondary|BMD (Total Hip and Forearm)|Change in BMD, using DXA results; active compared to placebo.|6 Months|Modified intent-to-treat population included all patients with pre-treatment and end-of-treatment evaluable DXA assessments. The patients are analyzed as randomized.||Percent change||Standard Deviation|Mean
672280|NCT01675128|Secondary|Objective Response|Objective response was evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR) is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non target) must have reduction in short axis to <10mm. Partial response (PR) is at least a 30% reduction in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease (PD) is at least a 20% increase in the sum of athe diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more lesions is also considered progression).|up to 2 cycles|Only 6/10 participants in Phase I, Dose Level II and 9/10 participants in Phase II were evaluable for response. Per protocol, no responses were to be reported for the Phase I Dose Level I Arm because the participants have different histologies, thus there are no objective responses for Phase I Dose Level I.||participants|||Number
672281|NCT01675128|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|21 months|||participants|||Number
672282|NCT01675128|Primary|Number of Participants With a Change in elF4e Protein Levels in Matched Pre and Post Tumor Biopsies|A change in protein is defined as an increase or decrease compared to baseline and is measured between two time points by immunohistochemistry (IHC) analysis.|2 weeks|Mandatory pre- and post-dose biopsies for elF4e messenger ribonucleic acid (mRNA) analysis was performed in the phase II portion of the study.||participants|||Number
672283|NCT01675128|Primary|Number of Participants With a Change in the Level of a Particular Gene Called elF4E [Eukaryotic Initiation Factors (elF)4e Messenger Ribonucleic Acid (mRNA) Levels] in Matched Pre and Post Tumor Biopsies|A change in elF4e levels is defined as an increase or decrease compared to baseline and is measured between two time points before rand after 2 weeks of treatment by quantitative real-time reverse transcription polymerase chain reaction (qRT-PCR).|2 weeks|Mandatory pre- and post-dose biopsies for elF4e messenger ribonucleic acid (mRNA) analysis was performed in the phase II portion of the study.||participants|||Number
672284|NCT01675128|Primary|Maximum Tolerated Dose of Irinotecan in Advanced Solid Tumors|MTD is the dose level at which no more than 1 of up to 6 patients experience dose-limiting toxicity (DLT) during the first 6 weeks of treatment, and no dose below that which at least 2 (of </=6) patients have DLT as a result of the drug.|2 years|||mg/m^2|||Number
672285|NCT01675128|Primary|Maximum Tolerated Dose (MTD) of ISIS 183750 in Advanced Solid Tumors|MTD is the dose level at which no more than 1 of up to 6 patients experience dose-limiting toxicity (DLT) during the first 6 weeks of treatment, and no dose below that which at least 2 (of </=6) patients have DLT as a result of the drug.|2 years|||mg|||Number
672286|NCT01675063|Primary|Establishment of a Dataset to Create an Algorithm to Measure Cardiac Output|The primary outcome of this work is to establish a dataset that would enable the calculation of a predicted cardiac output using waveform analysis from multiple sensors. The primary outcome of this work is the number of subjects that successfully contributed data.|8 hours post cardiac surgery|patients had undergone routine cardiac surgery. some patients did not have PA catheters placed and subsequently data was not obtained on cardiac output.||Participants|||Count of Participants
672287|NCT01675050|Secondary|Abdominal Pain|Participants rated the highest intensity of abdominal pain they experienced during the past two weeks on a scale of 0 (No Pain) to 10 (The Most Pain Possible), as derived from the “Abdominal Pain Index – Child Version” (Laird et al. 2015. Journal of Pediatric Psychology, 40(5), 517-525).|10 weeks|||units on a scale||Standard Deviation|Mean
672288|NCT01675050|Primary|Pressure Pain Threshold|Increasing pressures were applied with a pressure plunger to the participants' thumbnail. The pressure at which the participant said that s/he felt pain is noted. The pressure is measured in kilograms by centimeters squared.|at 4 weeks of cyproheptadine or placebo treatment|||kg/cm^2||Standard Deviation|Mean
672289|NCT01675011|Primary|Primary Endpoint|The primary effectiveness endpoint for this clinical trial is the proportion of subjects who have success, defined as 50% menstrual blood loss (MBL) reduction or less than 80 ml of MBL per cycle, evaluated by the Alkaline Hematin (AH) method, at 12 months.|12 Months post study procedure|The study was terminated due to inadequate enrollment; no patients completed the 12 month visit.|||||
672290|NCT01674725|Secondary|Percentage of Participants With Virologic Relapse After Treatment|Participants who completed treatment with plasma HCV RNA less than the lower limit of quantification (<LLOQ) at the end of treatment were considered to have virologic relapse if they had confirmed HCV RNA ≥ LLOQ during the post-treatment period. 95% CI was calculated using the Wilson score method for the single proportion because the point estimate was 0%.|Between End of Treatment (Week 12) and Post-treatment (up to Week 12 Post-Treatment)|All randomized participants with HCV subgenotype 1B (GT1b) infection who received at least 1 dose of coformulated ABT-450/r/ABT-267 and ABT-333, with or without RBV (ITT GT1b population) with HCV RNA < LLOQ at the final treatment visit and completed treatment.||percentage of participants||95% Confidence Interval|Number
672291|NCT01674725|Secondary|Percentage of Participants With Virologic Failure During Treatment|Virologic failure during treatment was defined as rebound (confirmed HCV RNA greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA < LLOQ during treatment, or confirmed increase from the lowest value post baseline in HCV RNA [2 consecutive HCV RNA measurements > 1 log10 IU/mL above the lowest value post baseline] at any time point during treatment), or failure to suppress (HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks [≥ 36 days] of treatment).|Baseline (Day 1), and Treatment Weeks 1, 2, 4, 6, 8, 10, and 12|All randomized participants with HCV subgenotype 1B (GT1b) infection who received at least 1 dose of coformulated ABT-450/r/ABT-267 and ABT-333, with or without RBV (intent-to-treat [ITT GT1b] population).||percentage of participants|||Number
672329|NCT01674634|Primary|Change From Baseline in Total Range of Motion|The total range of motion (ROM) is the sum of the range of motion measurements of the 2 treated joints. ROM is defined as difference between full flexion angle and full extension expressed in degrees. A positive change from baseline indicates increased (improved) ROM.|Baseline, Day 31|Efficacy analysis was based on the mITT population; all enrolled subjects who received both AA4500 injections and had a post-injection efficacy measure. Ten subjects were granted special re-enrollment and had an additional joint pair treated on the contralateral hand. Assessment is based on simultaneously treated joint pairs.||degrees|treated joint pairs|95% Confidence Interval|Mean
672292|NCT01674725|Secondary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Secondary Analyses|"The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.
The secondary efficacy endpoints were superiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333 with and without RBV) compared with the historical control rate for noncirrhotic, treatment-experienced participants with HCV GT1b treated with telaprevir and pegIFN/RBV; and the noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment who received ABT-450/r/ABT-267 and ABT-333 compared with those who received ABT-450/r/ABT-267 and ABT-333, plus RBV."|12 weeks after last dose of study drug|All randomized participants with HCV subgenotype 1B (GT1b) infection who received at least 1 dose of coformulated ABT-450/r/ABT-267 and ABT-333, with or without RBV (intent-to-treat [ITT GT1b] population); participants with missing data were counted as non-responders.||percentage of participants|||Number
672293|NCT01674725|Secondary|Percentage of Participants With Hemoglobin Decrease to Below the Lower Limit of Normal (LLN) At End of Treatment|The percentage of participants with a decrease in hemoglobin from greater than or equal to the lower limit of normal (≥ LLN) at baseline to < LLN at the end of treatment.|Baseline (Day 1) and Week 12 (End of Treatment)|All randomized participants with HCV subgenotype 1B (GT1b) infection who received at least 1 dose of coformulated ABT-450/r/ABT-267 and ABT-333, with or without RBV (intent-to-treat [ITT GT1b]) and had hemoglobin ≥ LLN reference range at baseline.||percentage of participants|||Number
672294|NCT01674725|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Primary Analyses|"The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug. The LLOQ for the assay was 25 IU/mL.
The primary efficacy endpoints were noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333 with and without RBV) compared with the historical control rate for noncirrhotic, treatment-experienced participants with HCV GT1b infection treated with telaprevir and peginterferon (pegIFN)/RBV."|12 weeks after last dose of study drug|All randomized participants with HCV subgenotype 1B (GT1b) infection who received at least 1 dose of coformulated ABT-450/r/ABT-267 and ABT-333, with or without RBV (intent-to-treat [ITT GT1b] population); participants with missing data were counted as non-responders.||percentage of participants|||Number
672295|NCT01674712|Secondary|Cystatin C|Collection and measurement of blood samples|12 weeks||||||
672296|NCT01674712|Secondary|Total Bilirubin|Collection and measurement of blood samples|12 weeks||||||
672297|NCT01674712|Secondary|Plasma Creatinine|Collection and measurement of blood samples|12 weeks||||||
672298|NCT01674712|Secondary|Alanine Aminotransferase (ALT)|Collection and measurement of blood samples|12 weeks||||||
672299|NCT01674712|Secondary|Creatine Kinase (CK)|Collection and measurement of blood samples|12 weeks||||||
672300|NCT01674712|Secondary|Adverse Events|Collection and measurement of blood samples|12 weeks||||||
672301|NCT01674712|Secondary|Percentage of Subjects Meeting Target Levels of Lipids (According to Very High or High Risk)|Collection and measurement of blood samples|12 weeks||||||
672302|NCT01674712|Secondary|Percentage of High-sensitivity C-reactive Protein (hsCRP) From Baseline|Collection and measurement of blood samples|12 weeks||||||
672303|NCT01674712|Secondary|Percentage of Apolipoprotein B From Baseline|Collection and measurement of blood samples|12 weeks||||||
672304|NCT01674712|Secondary|Percentage of Apolipoprotein AI From Baseline|Collection and measurement of blood samples|12 weeks||||||
672305|NCT01674712|Secondary|Percentage of TC (Triglyceride) From Baseline|Collection and measurement of blood samples|12 weeks||||||
672306|NCT01674712|Secondary|Percentage of Non-HDL (High Density Lipoprotein)-C From Baseline|Collection and measurement of blood samples|12 weeks||||||
672307|NCT01674712|Primary|Percentage of Change of LDL-C (Low Density Lipoprotein Cholesterol)|Collection and measurement of blood samples.|from baseline to 12 weeks of treatment|The Primary Analysis was done for the sample set of patients with 12 weeks' assessment.||percentage of change||Standard Deviation|Mean
672308|NCT01674712|Primary|Percentage of Change of HDL-C (High Density Lipoprotein Cholesterol)|Collection and measurement of blood samples.|from baseline to 12 weeks of treatment|The Primary Analysis was done for the sample set of patients with 12 weeks' assessment.||percentage of change||Standard Deviation|Mean
672309|NCT01674712|Primary|Percentage of Change of TG (Triglyceride)|Collection and measurement of blood samples.|from baseline to 12 weeks of treatment|The Primary Analysis was done for the sample set of patients with 12 weeks' assessment.||percentage of change||Standard Deviation|Mean
672310|NCT01674647|Secondary|Number of Participants With Composite of Major and Non-major Bleeding Events|All events were adjudicated and confirmed by a CEC blinded to treatment. The CEC categorized the bleeding events as major or non-major. The bleeding events were defined per the ISTH criteria. Clinically relevant bleeding included major bleeding (overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of 2 or more units of packed red blood cells or whole blood, occurring in a critical site or contributing to death) and non-major bleeding associated with medical intervention, unscheduled physician contact, (temporary) cessation of study treatment, discomfort for the participants such as pain, or impairment of activities of daily life. Number of subjects with clinically relevant major and non-major bleeding events were reported.|From randomization up to the date of the last dose of study drug + 2 days|The safety profile was analyzed using the SAF population. SAF population included all randomized subjects who received at least 1 dose of study medication.||Participants|||Number
672311|NCT01674647|Secondary|Number of Participants With All-cause Mortality|All events were adjudicated and confirmed by a CEC blinded to treatment. All-cause mortality included vascular death and non-vascular death. Number of subjects with all-cause mortality were reported.|From randomization to the date of last dose of study drug +2 days for subjects who completed planned treatment or the earlier date [last planned dose, follow-up visit at the end of 30-day follow-up period] for subjects who prematurely stopped treatment|The primary population for the efficacy analysis was the mITT population. mITT population included all the randomized subjects in whom a LA/LAA thrombus was not diagnosed during a TEE performed before the first planned cardioversion in the study.||Participants|||Number
672312|NCT01674647|Secondary|Number of Participants With Cardiovascular Deaths|All events were adjudicated and confirmed by a CEC blinded to treatment. Any death that was not clearly non-vascular (e.g., deaths due to spontaneous bleeding, myocardial infarction, stroke, cardiac failure, and arrhythmia). Number of subjects with cardiovascular deaths were reported.|From randomization to the date of last dose of study drug +2 days for subjects who completed planned treatment or the earlier date [last planned dose, follow-up visit at the end of 30-day follow-up period] for subjects who prematurely stopped treatment|The primary population for the efficacy analysis was the mITT population. mITT population included all the randomized subjects in whom a LA/LAA thrombus was not diagnosed during a TEE performed before the first planned cardioversion in the study.||Participants|||Number
672313|NCT01674647|Secondary|Number of Participants With Myocardial Infarctions|All events were adjudicated and confirmed by a CEC blinded to treatment. MI was assessed based onmeither cardiac biomarkers, new abnormal Q waves appeared on electrocardiogram for >= 2 leads, or autopsy confirmation. Number of subjects with MI were reported.|From randomization to the date of last dose of study drug +2 days for subjects who completed planned treatment or the earlier date [last planned dose, follow-up visit at the end of 30-day follow-up period] for subjects who prematurely stopped treatment|The primary population for the efficacy analysis was the mITT population. mITT population included all the randomized subjects in whom a LA/LAA thrombus was not diagnosed during a TEE performed before the first planned cardioversion in the study.||Participants|||Number
672314|NCT01674647|Secondary|Number of Participants With Non-central Nervous System Systemic Embolisms|All events were adjudicated and confirmed by a CEC blinded to treatment. Non CNS systemic embolism included emboli in peripheral arterial of the upper and lower extremities, ocular and retinal (pulmonary embolism and MI were excluded from the category). Number of subjects with non-CNS embolism were reported.|From randomization to the date of last dose of study drug +2 days for subjects who completed planned treatment or the earlier date [last planned dose, follow-up visit at the end of 30-day follow-up period] for subjects who prematurely stopped treatment|The primary population for the efficacy analysis was the mITT population. mITT population included all the randomized subjects in whom a LA/LAA thrombus was not diagnosed during a TEE performed before the first planned cardioversion in the study.||Participants|||Number
672315|NCT01674647|Secondary|Number of Participants With Transient Ischemic Attacks|All events were adjudicated and confirmed by a CEC blinded to treatment. Number of subjects with TIA were reported.|From randomization to the date of last dose of study drug +2 days for subjects who completed planned treatment or the earlier date [last planned dose, follow-up visit at the end of 30-day follow-up period] for subjects who prematurely stopped treatment|The primary population for the efficacy analysis was the mITT population. mITT population included all the randomized subjects in whom a LA/LAA thrombus was not diagnosed during a TEE performed before the first planned cardioversion in the study.||Participants|||Number
672316|NCT01674647|Secondary|Number of Participants With Strokes|All events were adjudicated and confirmed by a CEC blinded to treatment. Stroke included hemorrhagic (Stroke with local collections of intraparenchymal blood. Subarachnoid hemorrhage, subdural hemorrhage, and epidural hemorrhage were excluded), ischemic infarction (Stroke without focal collection of intracranial blood) and unknown (No imaging data and anatomic findings were available). Number of subjects with strokes were reported.|From randomization to the date of last dose of study drug +2 days for subjects who completed planned treatment or the earlier date [last planned dose, follow-up visit at the end of 30-day follow-up period] for subjects who prematurely stopped treatment|The primary population for the efficacy analysis was the mITT population. mITT population included all the randomized subjects in whom a LA/LAA thrombus was not diagnosed during a TEE performed before the first planned cardioversion in the study.||Participants|||Number
672317|NCT01674647|Secondary|Number of Participants With Composite of Strokes, Transient Ischemic Attacks, Non-central Nervous System Systemic Embolisms, Myocardial Infarctions and All-cause Mortality|Stroke, TIA, Non- CNS systemic embolism, MI and all-cause mortality were adjudicated and confirmed by CEC. Stroke included hemorrhagic and ischemic infarction. TIA including information if with or without matching lesion. Non CNS systemic embolism included emboli in peripheral arterial of the upper and lower extremities, ocular and retinal (pulmonary embolism and MI were excluded from the category). MI was assessed based on either cardiac biomarkers, new abnormal Q waves appeared on electrocardiogram for >= 2 leads, or autopsy confirmation. All-cause mortality included vascular death and non-vascular death. Number of subjects with composite events were reported.|From randomization to the date of last dose of study drug +2 days for subjects who completed planned treatment or the earlier date [last planned dose, follow-up visit at the end of 30-day follow-up period] for subjects who prematurely stopped treatment|The primary population for the efficacy analysis was the mITT population. mITT population included all the randomized subjects in whom a LA/LAA thrombus was not diagnosed during a TEE performed before the first planned cardioversion in the study.||Participants|||Number
672318|NCT01674647|Secondary|Number of Participants With Composite of Strokes and Non-central Nervous System Systemic Embolisms|Stroke and Non-CNS Embolism were adjudicated and confirmed by CEC. Stroke included hemorrhagic and ischemic infarction. Non CNS systemic embolism included emboli in peripheral arterial of the upper and lower extremities, ocular and retinal (pulmonary embolism and MI were excluded from the category). Number of subjects with composite events were reported.|From randomization to the date of last dose of study drug +2 days for subjects who completed planned treatment or the earlier date [last planned dose, follow-up visit at the end of 30-day follow-up period] for subjects who prematurely stopped treatment|The primary population for the efficacy analysis was the mITT population. mITT population included all the randomized subjects in whom a LA/LAA thrombus was not diagnosed during a TEE performed before the first planned cardioversion in the study.||Participants|||Number
672330|NCT01674634|Primary|Percent Change From Baseline in Total Fixed Flexion|Percent change from baseline in total fixed flexion = 100 * (baseline total FFC - day 31 total FFC)/baseline total FFC, where total fixed flexion is defined as the sum of the fixed flexion contracture (FCC) of the 2 joints receiving treatment. Positive percent change from baseline indicates improvement.|Baseline, Day 31|Efficacy analysis was based on the modified intent-to-treat (mITT) population; all enrolled subjects who received both AA4500 injections and had a post-injection efficacy measure. Ten subjects were granted special re-enrollment and had an additional joint pair treated on contralateral hand. Assessment is based on simultaneously treated joint pairs.||percentage of contracture change|Treated Joint Pairs|Standard Deviation|Mean
672319|NCT01674647|Primary|Number of Participants With Major Bleedings as Per Central Adjudication|Bleeding events were adjudicated and confirmed by CEC blinded to treatment. The CEC categorized the bleeding events as major or non-major. The bleeding events were defined per the International Society on Thrombosis and Hemostasis (ISTH) criteria. Major bleeding was clinically overt bleeding associated with a fall in hemoglobin of 2 gram per deciliter (g/dL) or higher, leading to a transfusion of 2 or more units of packed red blood cells or whole blood, occurring in a critical site or contributing to death. Number of subjects with confirmed adjudicated bleeding events occurring in greater than (>)1 total subjects were reported.|From randomization up to the date of the last dose of study drug + 2 days|The safety profile was analyzed using the safety analysis set (SAF) population. SAF population included all randomized subjects who received at least 1 dose of study medication.||Participants|||Number
672320|NCT01674647|Primary|Number of Participants With Composite of the Following Events, Adjudicated Centrally: Stroke, Transient Ischemic Attack, Non-central Nervous System Systemic Embolism, Myocardial Infarction and Cardiovascular Death|Stroke, TIA, Non-CNS Embolism, MI and cardiovascular death were adjudicated and confirmed by Clinical Endpoints Committee (CEC). Stroke included hemorrhagic and ischemic infarction. TIA including information if with or without matching lesion. Non CNS systemic embolism included emboli in peripheral arterial of the upper and lower extremities, ocular and retinal (pulmonary embolism and MI were excluded from the category). MI was assessed based on either cardiac biomarkers, new abnormal Q waves appeared on electrocardiogram for >= 2 leads, or autopsy confirmation. Cardiovascular death included death in subjects with non-valvular atrial fibrillation (AF). Number of subjects with composite events were reported.|From randomization to the date of last dose of study drug +2 days for subjects who completed planned treatment or the earlier date [last planned dose, follow-up visit at the end of 30-day follow-up period] for subjects who prematurely stopped treatment|The primary population for the efficacy analysis was the modified intention-to-treat (mITT) population. mITT population included all the randomized subjects in whom a left atrial/left atrial appendage (LA/LAA) thrombus was not diagnosed during a transesophageal echocardiogram (TEE) performed before the first planned cardioversion in the study.||Participants|||Number
672321|NCT01674634|Secondary|Change From Baseline for Unité Rhumatologique Des Affections de la Main Scale at Day 61|The URAM scale is a patient-reported functional 9-item scale (total score 0-45) developed and validated to assess functional outcome of patients suffering from Dupuytren's disease with higher scores indicating greater difficulty using the hand.The estimated clinically important change of the URAM scale is 2.9 points. A decrease in total URAM score indicates improvement in hand function.|Baseline, Day 61|Efficacy analysis was based on the mITT population; all enrolled subjects who received both AA4500 injections and had a post-injection efficacy measure. Ten subjects were granted special re-enrollment and had an additional joint pair treated on the contralateral hand. Assessment is based on simultaneously treated joint pairs.||units on a scale|Treated Joint Pairs|Standard Deviation|Mean
672322|NCT01674634|Secondary|Change From Baseline for Unité Rhumatologique Des Affections de la Main Scale at Day 31|The Unité Rhumatologique des Affections de la Main (URAM) scale is a patient-reported functional 9-item scale (total score 0-45) developed and validated to assess functional outcome of patients suffering from Dupuytren's disease with higher scores indicating greater difficulty using the hand.The estimated clinically important change of the URAM scale is 2.9 points. A decrease in total URAM score indicates improvement in hand function.|Baseline, Day 31|Efficacy analysis was based on the mITT population; all enrolled subjects who received both AA4500 injections and had a post-injection efficacy measure. Ten subjects were granted special re-enrollment and had an additional joint pair treated on the contralateral hand. Assessment is based on simultaneously treated joint pairs.||units on a scale|Treated Joint Pairs|Standard Deviation|Mean
672323|NCT01674634|Secondary|Investigator Assessment of Improvement With Treatment at Day 61|Investigator's determined the degree of improvement in the severity of the subject’s treated finger(s) compared with screening at the day 61 follow-up visit.|Day 61|Efficacy analysis was based on the mITT population; all enrolled subjects who received both AA4500 injections and had a post-injection efficacy measure. Ten subjects were granted special re-enrollment and had an additional joint pair treated on the contralateral hand. Assessment is based on simultaneously treated joint pairs.||Joint Pairs|Treated Joint Pairs||Number
672324|NCT01674634|Secondary|Investigator Assessment of Improvement With Treatment at Day 31|Investigator's determined the degree of improvement in the severity of the subject’s treated finger(s) compared with screening at the day 31 follow-up visit.|Day 31|Efficacy analysis was based on the mITT population; all enrolled subjects who received both AA4500 injections and had a post-injection efficacy measure. Ten subjects were granted special re-enrollment and had an additional joint pair treated on the contralateral hand. Assessment is based on simultaneously treated joint pairs.||Joint Pairs|Treated Joint Pairs||Number
672325|NCT01674634|Secondary|Subject Assessment of Satisfaction With Treatment at Day 61|Subject's were asked to rate satisfaction with treatment at the day 61 follow-up visit|Day 61|Efficacy analysis was based on the mITT population; all enrolled subjects who received both AA4500 injections and had a post-injection efficacy measure. Ten subjects were granted special re-enrollment and had an additional joint pair treated on the contralateral hand. Assessment is based on simultaneously treated joint pairs.||Joint Pairs|Treated Joint Pairs||Number
672326|NCT01674634|Secondary|Subject Assessment of Satisfaction With Treatment at Day 31|Subject's were asked to rate satisfaction with treatment at the day 31 follow-up visit|Day 31|Efficacy analysis was based on the mITT population; all enrolled subjects who received both AA4500 injections and had a post-injection efficacy measure. Ten subjects were granted special re-enrollment and had an additional joint pair treated on the contralateral hand. Assessment is based on simultaneously treated joint pairs.||Joint Pairs|Treated Joint Pairs||Number
672327|NCT01674634|Secondary|Clinical Improvement|Clinical improvement is defined as a reduction of FFC by 50% or greater of the baseline value within 30 days of injection|Within 30 days|Efficacy analysis was based on the mITT population; all enrolled subjects who received both AA4500 injections and had a post-injection efficacy measure. Ten subjects were granted special re-enrollment and had an additional joint pair treated on the contralateral hand. This assessment is based on individual treated joints by joint type.||Joints|Treated Joints||Number
672331|NCT01674621|Secondary|Safety and Tolerability|Physical examinations, vital signs, electrocardiograms, clinical laboratory tests, local tolerance, and adverse events.|6 Months||||||
672335|NCT01674062|Secondary|Cohorts 1 and 2: Overall Survival (OS)|Participants were followed for survival data during and after treatment for a maximum of 3 years after the last dose until death, withdrawal of consent, or loss to follow-up. OS was defined as the time from first dose to the time of death from any cause. Participants who did not experience death were censored at the last known alive date. OS was estimated using Kaplan-Meier and expressed in months.|Up to approximately 4.5 years (during treatment; then every 4 months until death, withdrawn consent, loss to follow-up, or 3 years after last dose; final analysis using November 2010 cutoff date)|All Treated Population (Cohorts 1 and 2 only).||months||80% Confidence Interval|Median
672336|NCT01674062|Secondary|Cohorts 1 and 2: Percentage of Participants Who Died|Participants were followed for survival data during and after treatment for a maximum of 3 years after the last dose until death, withdrawal of consent, or loss to follow-up. The percentage of participants who died was calculated as [number of participants with event divided by the number analyzed] multiplied by 100.|Up to approximately 4.5 years (during treatment; then every 4 months until death, withdrawn consent, loss to follow-up, or 3 years after last dose; final analysis using November 2010 cutoff date)|All Treated Population (Cohorts 1 and 2 only).||percentage of participants|||Number
672337|NCT01674062|Secondary|Cohorts 1 and 2: Progression-Free Survival (PFS) According to RECIST Version 1.0|Tumor response was assessed using RECIST version 1.0 to assess for disease progression, defined as at least a 20% increase in the sum of the longest diameter, taking as reference the smallest sum of the longest diameter observed at previous tumor assessment, or the appearance of any new lesions. PFS was defined as the time from first dose to the time of disease progression or death. Participants without progression or death were censored at the last tumor assessment. PFS was estimated using Kaplan-Meier analysis and expressed in weeks.|Up to approximately 9.5 years (at Screening; on Day 15 of Cycles 2, 4, 6, and 8 [cycle length 3 weeks]; then every 3 months until disease progression)|All Treated Population (Cohorts 1 and 2 only).||weeks||80% Confidence Interval|Median
672338|NCT01674062|Secondary|Cohorts 1 and 2: Time to Progression (TTP) According to RECIST Version 1.0|Tumor response was assessed using RECIST version 1.0 to assess for disease progression, defined as at least a 20% increase in the sum of the longest diameter, taking as reference the smallest sum of the longest diameter observed at previous tumor assessment, or the appearance of any new lesions. TTP was defined as the time from first dose to the time of first documented disease progression. Participants who withdrew from the study without documented progression were censored at the last tumor assessment. TTP was estimated using Kaplan-Meier analysis and expressed in weeks.|Up to approximately 9.5 years (at Screening; on Day 15 of Cycles 2, 4, 6, and 8 [cycle length 3 weeks]; then every 3 months until disease progression)|All Treated Population (Cohorts 1 and 2 only).||weeks||Full Range|Median
672339|NCT01674062|Secondary|Cohorts 1 and 2: Percentage of Participants With Disease Progression According to RECIST Version 1.0|Tumor response was assessed using RECIST version 1.0 to assess for disease progression, defined as at least a 20% increase in the sum of the longest diameter, taking as reference the smallest sum of the longest diameter observed at previous tumor assessment, or the appearance of any new lesions. The percentage of participants with disease progression was calculated as [number of participants meeting the above criteria divided by the number analyzed] multiplied by 100.|Up to approximately 9.5 years (at Screening; on Day 15 of Cycles 2, 4, 6, and 8 [cycle length 3 weeks]; then every 3 months until disease progression)|All Treated Population (Cohorts 1 and 2 only).||percentage of participants|||Number
672340|NCT01674062|Secondary|Cohorts 1 and 2: Time to Objective Response According to RECIST Version 1.0|Tumor response was assessed using RECIST version 1.0 to determine the OR rate. Time to response was defined as the time from first dose to the time of initial response of CR or PR. CR was defined as the disappearance of all target lesions, and PR was defined as at least a 30% decrease in the sum of the longest diameter compared to Baseline. Participants with disease progression were censored at the time of progression, and those with neither disease progression nor OR were censored at the last tumor assessment. Time to response was estimated using Kaplan-Meier analysis and expressed in weeks.|Up to approximately 21 months (at Screening; on Day 15 of Cycles 2, 4, 6, and 8 [cycle length 3 weeks]; then every 3 months until disease progression; final analysis using February 2008 cutoff date)|All Treated Population (Cohorts 1 and 2 only).||weeks||Full Range|Median
672341|NCT01674062|Secondary|Cohorts 1 and 2: Duration of Response According to RECIST Version 1.0|Tumor response was assessed using RECIST version 1.0 to determine OR and CBR rates. Duration of OR was defined as time from initial response of CR or PR to time of disease progression or death. Duration of CBR was defined similarly as time from initial response of CR or PR, or SD lasting at least 6 months, to time of disease progression or death. CR was defined as the disappearance of all target lesions, and PR was defined as at least a 30% decrease in the sum of the longest diameter compared to Baseline. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient (20%) increase to qualify for disease progression, in addition to no new target lesions. Participants without progression or death following confirmed CR or PR were censored at the last tumor assessment. Duration of response was estimated using Kaplan-Meier analysis and expressed in weeks.|Up to approximately 9.5 years (at Screening; on Day 15 of Cycles 2, 4, 6, and 8 [cycle length 3 weeks]; then every 3 months until disease progression)|All Treated Population (Cohorts 1 and 2 only).||weeks||Full Range|Median
672342|NCT01674062|Secondary|Cohort 3: Percentage of Participants With a Confirmed Best Overall Response of CR, PR, or SD According to RECIST Version 1.0 During Single-Agent Treatment With Pertuzumab|Tumor response was assessed using RECIST version 1.0 to determine the CBR rate, or the percentage of participants with either confirmed CR or PR, or SD lasting at least 6 months. CR was defined as the disappearance of all target lesions, and PR was defined as at least a 30% decrease in the sum of the longest diameter compared to Baseline. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient (20%) increase to qualify for disease progression, in addition to no new target lesions. Response was to be confirmed a minimum of 4 weeks after the initial response was documented. The CBR rate was calculated as [number of participants meeting the above criteria divided by the number analyzed] multiplied by 100.|Up to approximately 7.5 years (at Screening; on Day 15 of Cycles 2, 4, 6, and 8 [cycle length 3 weeks]; then every 3 months until disease progression)|All Treated Population (Cohort 3 only).||percentage of participants||80% Confidence Interval|Number
672402|NCT01673568|Primary|Visual Analog Scale of Pain Activity|Outcome is based on patient self-reported registrations using Visual Analog Scales (VAS) where 0 is no pain in activity and 100 is worst imaginable pain in activity.|24 hours after hernia repair|||units on a scale||Full Range|Median
672343|NCT01674062|Secondary|Cohort 3: Percentage of Participants With a Confirmed Best Overall Response of CR or PR According to RECIST Version 1.0 During Single-Agent Treatment With Pertuzumab|Tumor response was assessed using RECIST version 1.0 to determine the OR rate, or the percentage of participants with either confirmed CR or PR. CR was defined as the disappearance of all target lesions, and PR was defined as at least a 30% decrease in the sum of the longest diameter compared to Baseline. Response was to be confirmed a minimum of 4 weeks after the initial response was documented. The OR rate was calculated as [number of participants meeting the above criteria divided by the number analyzed] multiplied by 100.|Up to approximately 7.5 years (at Screening; on Day 15 of Cycles 2, 4, 6, and 8 [cycle length 3 weeks]; then every 3 months until disease progression)|All Treated Population (Cohort 3 only).||percentage of participants||80% Confidence Interval|Number
672344|NCT01674062|Primary|Cohorts 1 and 2: Percentage of Participants With a Confirmed Best Overall Response of CR, PR, or Stable Disease (SD) According to RECIST Version 1.0 During Dual-Agent Treatment|Tumor response was assessed using RECIST version 1.0 to determine the clinical benefit response (CBR) rate, or the percentage of participants with either confirmed CR or PR, or SD lasting at least 6 months. CR was defined as the disappearance of all target lesions, and PR was defined as at least a 30% decrease in the sum of the longest diameter compared to Baseline. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient (20%) increase to qualify for disease progression, in addition to no new target lesions. Response was to be confirmed a minimum of 4 weeks after the initial response was documented. The CBR rate was calculated as [number of participants meeting the above criteria divided by the number analyzed] multiplied by 100.|Up to approximately 9.5 years (at Screening; on Day 15 of Cycles 2, 4, 6, and 8 [cycle length 3 weeks]; then every 3 months until disease progression)|All Treated Population (Cohorts 1 and 2 only).||percentage of participants||80% Confidence Interval|Number
672345|NCT01674062|Primary|Cohorts 1 and 2: Percentage of Participants With a Confirmed Best Overall Response of Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 During Dual-Agent Treatment|Tumor response was assessed using RECIST version 1.0 to determine the objective response (OR) rate, or the percentage of participants with either confirmed CR or PR. CR was defined as the disappearance of all target lesions, and PR was defined as at least a 30 percent (%) decrease in the sum of the longest diameter compared to Baseline. Response was to be confirmed a minimum of 4 weeks after the initial response was documented. The OR rate was calculated as [number of participants meeting the above criteria divided by the number analyzed] multiplied by 100.|Up to approximately 9.5 years (at Screening; on Day 15 of Cycles 2, 4, 6, and 8 [cycle length 3 weeks]; then every 3 months until disease progression)|All Treated Population (Cohorts 1 and 2 only).||percentage of participants||80% Confidence Interval|Number
672346|NCT01674010|Secondary|Time to Recurrence of a Manic/Hypomanic or a Mixed Episode||up to 48 weeks|Study was prematurely terminated, no data were collected for this Outcome Measure|||||
672347|NCT01674010|Secondary|Time to Recurrence of a Depressive Episode||up to 48 weeks|Study was prematurely terminated, no data were collected for this Outcome Measure|||||
672348|NCT01674010|Secondary|Proportion of Study Participants With Recurrence of Any Mood Episode||up to 48 weeks|Study was prematurely terminated, no data were collected for this Outcome Measure|||||
672349|NCT01674010|Primary|Treatment Emergent Adverse Events|The study was terminated early so no efficacy analysis was done, safety data are reported.|up to 48 weeks|TEAEs reported for Phase 2 were from the entire study period||participants|||Number
672350|NCT01673984|Secondary|Percentage of Participants Who Changed Injection Frequency After Completion of the Study||Month 12|Analysis based on the number of subjects with a valid value in the ITT population which comprised of 21 patients.||percentage of participants|||Number
672351|NCT01673984|Secondary|Patient Satisfaction With Treatment.|Using a non-validated study-specific descriptive Likert-type scale (with no units) comprising a simple six-question patient questionnaire.|Month 12|No participant analysis as no data was collected due to low number of participants recruited in the study.|||||
672352|NCT01673984|Secondary|Change From Baseline in Patient Satisfaction With Medication Using Treatment Satisfaction Questionnaire for Medication (TSQM Version II)|TSQM comprised of four dimensions: effectiveness, side effects, convenience and overall global satisfaction. Each score ranged from 0 to 100. For effectiveness, convenience and overall global satisfaction scores, 0 indicated an extreme dissatisfaction and 100 indicated an extreme satisfaction. For side effects score, 0 indicated an extreme dissatisfaction and 100 indicated no dissatisfaction at all.|6 and 12 month|Analysis based on the number (n) of subjects with a valid value in each arm of the ITT population which comprised of 21 patients.||units on a scale||95% Confidence Interval|Mean
672353|NCT01673984|Secondary|Change From Baseline in Quality of Life Using EuroQol 5 Dimensions 5 Levels [EQ-5D-5L] Questionnaire.|The EQ-5D-5L questionnaire consisted of a description of raw data which comprised of five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension had five levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The visual analogical scale of the EQ-5D-5L questionnaire was numbered from 0 to 100 (0 meaning the worst health the patient can imagine and 100 the best health the patient can imagine).|Baseline and Month 12|Analysis based on the number of subjects with a valid value in the ITT population which comprised of 21 patients.||units on a scale||95% Confidence Interval|Mean
672354|NCT01673984|Secondary|Percentage of Participants Demonstrating Stable Prostate-specific Antigen (PSA) Levels|Stable PSA level was noted as value either lower or less than 25% higher than the baseline value, or PSA value ≤0.5 ng/mL higher than the baseline value, if value ≥25% higher than the baseline value.|6 and 12 months|Analysis based on number (n) of patients with a valid value in the intent-to-treat (ITT) population which comprised of 21 patients.||percentage of participants|||Number
672355|NCT01673984|Secondary|Percentage of Participants Maintaining Biochemical Castration After 12 Months of Treatment.|Patients with serum total testosterone (STT) level lower than 0.5 ng/mL, 12 months after randomisation..|12 months|Analysis based on the number of subjects with a valid value in the ITT population comprised of 21 patients.||percentage of participants|||Number
672356|NCT01673984|Primary|Percentage of Participants Maintaining Biochemical Castration|Patients with serum total testosterone (STT) level lower than 0.5 ng/mL after 6 months of treatment.|6 months|Analysis based on intent-to-treat (ITT) population comprised of 21 patients.||percentage of participants|||Number
672357|NCT01673919|Secondary|Parent/Patient's Discomfort Index (Pain)|Participants or parents rated participant's pain by placing a horizontal line on a VAS of 0 (no pain) - 100 mm (unbearable pain). To describe the pain, a cut-off at 10 mm was used, and VAS <10 mm was defined as no pain.|Baseline (Day 1), Weeks 12, 24, 36, 48, 60, 72, 84, and 108|The ITT population included all the participants who had at least one efficacy assessment. n = number of participants analyzed for the given parameter at the specified visit.||mm||Standard Deviation|Mean
672358|NCT01673919|Secondary|Parent/Patient's Global Assessment of Disease Activity|Parent/patient global assessment of disease activity was performed using 0 to 100 mm VAS, and higher the score of VAS, worse the disease status (0= absence of activity or sign or symptom; 100= maximal activity or signs or symptoms). No disease activity was defined as VAS <=10 mm.|Baseline (Day 1), Weeks 12, 24, 36, 48, 60, 72, 84, and 108|The ITT population included all the participants who had at least one efficacy assessment. n = number of participants analyzed for the given parameter at the specified visit.||mm||Standard Deviation|Mean
672359|NCT01673919|Secondary|Physician’s Global Assessment of Disease Activity|The Physician's global assessment of disease activity was recorded on a 0 to 100 mm horizontal VAS where score 0 represented ‘arthritis inactive’ (i.e., symptom-free and no arthritis symptoms) and score 100 represented ‘arthritis very active’ (higher score indicate worsening of disease).|Baseline (Day 1), Weeks 12, 24, 36, 48, 60, 72, 84, and 108|The ITT population included all the participants who had at least one efficacy assessment. n = number of participants analyzed for the given parameter at the specified visit.||millimeter (mm)||Standard Deviation|Mean
672360|NCT01673919|Secondary|Number of Painful Joints|The painful joints were counted by physical examination and mean painful joints was reported.|Baseline (Day 1), Weeks 12, 24, 36, 48, 60, 72, 84, and 108|The ITT population included all the participants who had at least one efficacy assessment. n = number of participants analyzed for the given parameter at the specified visit.||joints||Standard Deviation|Mean
672361|NCT01673919|Secondary|Number of Swollen Joints|The swollen joints was counted by physical examination and mean swollen joints were reported.|Baseline (Day 1), Weeks 12, 24, 36, 48, 60, 72, 84, and 108|The ITT population included all the participants who had at least one efficacy assessment. n = number of participants analyzed for the given parameter at the specified visit.||joints||Standard Deviation|Mean
672362|NCT01673919|Secondary|Number of Joints With Active Range of Motion|The active range of motion joints was counted by physical examination and mean joints was reported.|Baseline (Day 1), Weeks 12, 24, 36, 48, 60, 72, 84, and 108|The ITT population included all the participants who had at least one efficacy assessment. n = number of participants analyzed for the given parameter at the specified visit.||joints||Standard Deviation|Mean
672363|NCT01673919|Secondary|Number of Joints With Limitation of Motion|The most frequent symptom reported by most participants was a limitation of motion (LOM) of joints and it was determined by physical examination. The mean joints with limitation of motion were reported.|Baseline (Day 1), Weeks 12, 24, 36, 48, 60, 72, 84, and 108|The ITT population included all the participants who had at least one efficacy assessment. n = number of participants analyzed for the given parameter at the specified visit.||joints||Standard Deviation|Mean
672364|NCT01673919|Secondary|Number of Participants With a Minimally Important Improvement in the Childhood Health Assessment Questionnaire-Disability Index|The CHAQ-DI included questions on dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities. The disability index (DI) of the original CHAQ was graded on 4-point categorical scales of 30 items grouped into 8 domains of physical function. The highest scoring item in each domain determined the score for that domain. The score for the disability index was the mean of domain scores ranging from 0 to 3 (0 = without any difficulty and 3 = unable to do) with higher scores meaning higher disability. Minimally important improvement in CHAQ-DI was defined as a change from baseline of WA19977 core study (Day 1/Visit 1) >=0.13 at each visit.|Weeks 12, 24, 36, 48, 60, 72, 84, and 108|The ITT population included all the participants who had at least one efficacy assessment. n = number of participants analyzed for the given parameter at the specified visit.||participants|||Number
672365|NCT01673919|Secondary|Number of Participants Achieving Clinical Remission|Clinical remission was defined as inactive disease observed for at least 6 continuous months. Clinical remission was defined as per medication uptake as: Level 1 (clinical remission on medication), Level 2 (clinical remission off oral corticosteroid medication [still on TCZ]), Level 3 (clinical remission off both oral corticosteroid and methotrexate medication [still on TCZ]), and Level 4 (clinical remission off all anti-inflammatory medications [still on TCZ]). Number of participants at each clinical remission level was reported.|Weeks 24, 36, 48, 72, and 108|The ITT population included all participants who had at least one efficacy assessment. n = number of participants analyzed for the given parameter at the specified visit.||participants|||Number
672366|NCT01673919|Secondary|Number of Participants With Inactive Disease|Inactive disease was defined as: 1) No joints with active arthritis (no swollen, painful and lack of motion joints), 2) No fever, rash, serositis, splenomegaly, or generalized lymphadenopathy attributable to JIA, 3) No active uveitis, 4) ESR and/or CRP within normal range, and 5) No disease activity according to Physician's global assessment of disease activity (<= 10 millimeters [mm] on a VAS). The participant’s treating physician provided a rating of the participant’s arthritis disease activity on a 0 to 100 mm horizontal scale where score 0 represented ‘arthritis inactive’ (i.e., symptom-free and no arthritis symptoms) and score 100 represented ‘arthritis very active’.|Weeks 24, 36, 48, 72, and 108|The ITT population included all participants who had at least one efficacy assessment. n = number of participants analyzed for the given parameter at the specified visit.||participants|||Number
672378|NCT01673867|Secondary|Overall Survival (OS) Time in Months by Baseline PD-L1 Expression for All Randomized Participants at Primary Endpoint|Overall Survival time was measured in months for all randomized participants grouped by their baseline PD-L1 expression level. PD-L1 expression in participants was defined as the percent of disease tumor cells demonstrating plasma membrane PD-L1 staining of any intensity using an immunohistochemistry (IHC) assay. Interim analysis (Primary Endpoint) was planned to occur after at least 380 deaths, with the actual analysis occurring at 413 deaths.|Randomization until 413 deaths, up to March 2015 (approximately 29 months)|All randomized participants||months||95% Confidence Interval|Median
672458|NCT01673178|Primary|Change From Baseline in Creatine Phosphokinase (CPK) Level at Day 25||Baseline, Day 25|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.||U/L||Full Range|Median
672367|NCT01673919|Secondary|Number of Participants With Juvenile Idiopathic Arthritis American College of Rheumatology Response 50/70|The Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) is comprised of six components: Maximum number of joints with active arthritis; Number of joints with limitation of movement; Erythrocyte Sedimentation Rate (ESR) and/or C-reactive Protein (CRP); Childhood Health Assessment Questionnaire-Disease Index (CHAQ-DI) graded on 4-point scales [0 = without any difficulty and 3 = unable to do] of 30 items grouped into 8 domains of physical function; Physician’s global assessment of disease activity and Participant’s global assessment of overall well-being (both assessed on a 0 to 100 mm Visual Analogue Scale [VAS], where score 0 = inactive arthritis and 100 = very active arthritis). A JIA ACR50/70 response is defined as improvement in at least three of the six core components by at least 50 percent (%), or 70%, respectively and no more than one of the remaining core components worsening by more than 30%.|Weeks 12, 24, 36, 48, 60, 72, 84, and 108|The ITT population included all participants who had at least one efficacy assessment. Number (n) = number of participants analyzed for the given parameter at the specified visit.||participants|||Number
672368|NCT01673919|Secondary|Number of Participants With Abnormality in Physical Examinations|Participants with abnormal physical examinations of ear, nose and throat (asthma); extremities (synovitis, sequelae with flexion of the 5th right proximal interphalangeal joint, hallux valgus, deviations of metatarsophalangeal joints, and callus under metatarsal head); lung (mild bronchospasm); skin (vitiligo and hematoma, fatty subcutaneous infiltration on the neck, cutaneous eruption, and scalp pediculosis); and musculoskeletal system (discomfort in right hip) were reported.|Approximately 2 years|Safety population included all participants who received at least a single dose of study drug.||participants|||Number
672369|NCT01673919|Secondary|Number of Participants With Clinically Significant Abnormal Laboratory Parameters|Clinically significant abnormal parameters included eosinophil count, alanine aminotransferase, total bilirubin, and protein and blood in urine. Number of participants with these abnormal lab parameters was reported.|Approximately 2 years|Safety population included all participants who received at least a single dose of study drug.||participants|||Number
672370|NCT01673919|Secondary|Number of Participants With AEs Leading to TCZ Modification, AEs Leading to Death, Anaphylaxis or Serious Hypersensitivity and Deaths|Number of participants with AEs leading to TCZ modification, AEs leading to death, anaphylaxis or serious hypersensitivity, and deaths were reported.|Approximately 2 years|Safety population included all participants who received at least a single dose of study drug.||participants|||Number
672371|NCT01673919|Secondary|Mean Duration of Study Follow-Up|The participants were followed-up from Day 1 to last visit date (approximately 2 years). Mean time for which participants were followed up in the study was reported.|Approximately 2 years|Safety population included all participants who received at least a single dose of study drug.||Months||Standard Deviation|Mean
672372|NCT01673919|Secondary|Mean Exposure to Study Treatment|Participants received TCZ for Week 104 or when TCZ was commercially available for pcJIA participants, whichever comes first in France. The mean TCZ exposure (time from first to last administration) was reported.|Approximately 2 years|Safety population included all participants who received at least a single dose of study drug.||Months||Standard Deviation|Mean
672373|NCT01673919|Primary|Number of Participants With Adverse Events Related to Tocilizumab|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. Relatedness of any AEs was reported as possibly related, probably related, or remotely related to TCZ.|Approximately 2 years|Safety population included all participants who received at least a single dose of study drug.||participants|||Number
672374|NCT01673919|Primary|Number of Participants With Adverse Events of Special Interest|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. The AEs of special interests included gingival bleeding, tooth abscess, acarodermatitis, ear infection, gastroenteritis, herpes zoster ophthalmic, lice infestation, nasopharyngitis, oral fungal infection, oral herpes, pharyngitis, rhinitis, sinusitis, tonsillitis, tracheitis, tracheobronchitis, urinary tract infection, menorrhagia, asthma, epistaxis, and hematoma.|Approximately 2 years|Safety population included all participants who received at least a single dose of study drug.||participants|||Number
672375|NCT01673919|Primary|Number of Participants With Any Adverse Events and Any Serious Adverse Events|An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An serious adverse event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.|Approximately 2 years|Safety population included all participants who received at least a single dose of study drug.||participants|||Number
672376|NCT01673867|Secondary|Objective Response Rate (ORR) by Baseline PD-L1 Expression for All Randomized Participants at Primary Endpoint|ORR was reported for all randomized participants grouped by their baseline PD-L1 expression level. PD-L1 expression in participants was defined as the percent of disease tumor cells demonstrating plasma membrane PD-L1 staining of any intensity using an immunohistochemistry (IHC) assay. ORR was defined as the percentage of all randomized participants whose Best Overall Response (BOR) was a confirmed Complete Response (CR) or Partial Response (PR). CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters. CIs were computed using the Clopper and Pearson method.|Randomization until 413 deaths, up to March 2015 (approximately 29 months)|All randomized participants||percentage of participants||95% Confidence Interval|Number
672377|NCT01673867|Primary|Number of Deaths From Any Cause in All Randomized Participants at Primary Endpoint|The number of participants who died from any cause was reported for each arm. Interim analysis (Primary Endpoint) was planned to occur after at least 380 deaths, with the actual analysis occurring at 413 deaths.|Randomization until 413 deaths, up to March 2015 (approximately 29 months)|All randomized participants||participants|||Number
673448|NCT01662765|Secondary|Healing Time|the time form initial treatment to healing the wound and/or sinus and/or granulation tissue and no any sign of drainage with no longer need for dressing and wound care in either treatment arms.|two year|||days||Standard Deviation|Mean
672379|NCT01673867|Secondary|Percentage of Participants Experiencing Disease-related Symptom Improvement by Week 12|Disease-related symptom improvement rate by Week 12 was defined as the percentage of randomized participants who had a 10 point or greater decrease from baseline in average symptom burden index score at any time between randomization and Week 12. The participant portion of the Lung Cancer Symptom Scale (LCSS) consisted of 6 symptom-specific questions that addressed cough, dyspnea, fatigue, pain, hemoptysis, and anorexia, plus 3 summary items on symptom distress, interference with activity level, and global health-related Quality of Life (QoL). The scores range from 0 to 100, with 0 representing the best possible score and 100 being the worst possible score. The average symptom burden index score at each assessment was defined as the mean of the 6 symptom-specific questions of the LCSS. 95% CIs were computed using Clopper-Pearson Method.|Randomization to Week 12|All randomized participants||percentage of participants||95% Confidence Interval|Number
672380|NCT01673867|Primary|One-year Overall Survival (OS) Rate in All Randomized Participants|The one-year overall survival rate is a percentage, representing the fraction of all randomized participants who were alive following one year of treatment. Overall survival was defined as the time between the date of randomization and the date of death as a result of any cause. Survival rates were determined via Kaplan-Meier estimates.|12 months|All Randomized Participants||percentage of participants||95% Confidence Interval|Number
672381|NCT01673867|Secondary|Progression-Free Survival (PFS) Time in Months for All Randomized Participants at Primary Endpoint|PFS was defined as the time from the date of randomization to the date of the first documented tumor progression as determined by the investigator per RECIST v1.1 criteria, or death due to any cause. Participants underwent radiographic tumor assessments every 6 weeks (+/- 5 days) from week 9 (+/- 5 days) for the first year on treatment, then every 12 weeks after the first year on treatment until documented disease progression. The PFS curves were estimated using KM method. Two-sided 95% CIs for median PFS were computed by Brookmeyer and Crowley method (using log-log transformation). Interim analysis (Primary Endpoint) was planned to occur after at least 380 deaths, with the actual analysis occurring at 413 deaths.|Randomization until 413 deaths, up to March 2015 (approximately 29 months)|All randomized participants||months||95% Confidence Interval|Median
672382|NCT01673867|Secondary|Progression-Free Survival (PFS) Rate at 12 Months|PFS rate was defined as the percentage of participants experiencing no disease progression or death from any cause at 12 months after randomization. Progression was assessed by investigators according to RECIST v1.1. 95% CIs were estimated using the Kaplan-Meier method.|Randomization to 12 months|All randomized participants||percentage of participants||95% Confidence Interval|Number
672383|NCT01673867|Secondary|Time To Response (TTR) in Months for All Confirmed Responders at Primary Endpoint|Time to Response (TTR) for participants demonstrating a response (either CR or PR) was defined as the time from the date of randomization to the date of the first confirmed response. CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters.|Randomization until confirmed response, up to March 2015 (approximately 29 months)|All randomized participants who demonstrate partial response or complete response||months||Full Range|Median
672384|NCT01673867|Secondary|Duration of Objective Response (DOR) in Months for All Confirmed Responders at Primary Endpoint|"DOR was defined as the time from the date of first confirmed response to the date of the first documented tumor progression (per RECIST v1.1), as determined by the investigator, or death due to any cause, whichever occurred first. DOR was evaluated only for confirmed responders (i.e. participants with confirmed CR or PR).
CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters.
Participants who neither progressed nor died were censored on the date of their last evaluable tumor assessment."|Date of confirmed response to date of documented tumor progression or death, up to March 2015 (approximately 29 months)|All randomized participants who demonstrate partial response (PR) or complete response (CR).||months||Full Range|Median
672385|NCT01673867|Secondary|Objective Response Rate (ORR) in All Randomized Participants at Primary Endpoint|"ORR was defined as the percentage of participants whose Best Overall Response (BOR) was a confirmed Complete Response (CR) or Partial Response (PR). BOR was defined as the best investigator-assessed response designation, recorded between the date of randomization and the date of objectively documented progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) or the date of subsequent anti-cancer therapy (excluding on-treatment palliative radiotherapy of non-target bone lesions or Central Nervous System (CNS) lesions), whichever occurred first.
CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters. CIs were computed using the Clopper and Pearson method."|Randomization until 413 deaths, up to March 2015 (approximately 29 months)|All Randomized Participants||percentage of participants||95% Confidence Interval|Number
672386|NCT01673867|Primary|Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint|OS was defined as the time between the date of randomization and the date of death from any cause. Participants were censored at the date they were last known to be alive. Median OS time was calculated using Kaplan-Meier (KM) method. Hazard ratio (HR) and the corresponding Confidence Interval (CI) were estimated in a stratified Cox proportional hazards model for distribution of OS in each randomized arm. Interim analysis (Primary Endpoint) was planned to occur after at least 380 deaths, with the actual analysis occurring at 413 deaths.|Randomization until 413 deaths, up to March 2015 (approximately 29 months)|All randomized participants||months||95% Confidence Interval|Median
672400|NCT01673594|Primary|Change in Score on AISRS From Baseline to Week 6|The Adult ADHD Investigator System Report Scale (AISRS) is an 18-item, DSM-IV symptom Likert scale that measures ADHD symptoms in adults. Each of the individual symptoms of ADHD is rated from 0 to 3 on a scale of severity (3 being more severe symptoms). Total scores range from 0 to 54; higher scores indicate greater symptom severity. Change was calculated as value at baseline minus value at 6 weeks.|Baseline and 6 Weeks|||units on a scale||Standard Deviation|Mean
672401|NCT01673568|Secondary|Seroma Formation|Seroma formation measured on day 7 postoperatively with trans abdominal ultrasound scan (US). The method used in this study to estimate the volume of seroma is to measure the longitudinal section and cross section of the effusion and thereby calculating the volume.|postoperative day 7|||mL||Full Range|Median
672387|NCT01673854|Other Pre-specified|Number of Participants With Adverse Events (AEs) Grade 3-4, Related AEs Grade 3-4, Related Serious Adverse Events (SAEs) Grade 3-4, Immune-related (ir) AEs Grade 3-4, and Serious irAEs Grade 3-4|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or unknown relationship to study drug. Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death.|From the first dose date of Vem1 to the last dose of ipilimumab (to a maximum of 3 years) + 90 days or to the first dose date of Vem2, whichever occurred first|All participants who received at least 1 dose of study drug||Participants|||Number
672388|NCT01673854|Other Pre-specified|Number of Participants Who Died, Who Died Due to Related Adverse Events (AEs), and With Related AEs, Serious Adverse Events (SAEs), Related SAEs, Discontinuations Due to AEs and Related AEs, Immune-related (ir) AEs, and Serious irAEs|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or unknown relationship to study drug.|From the first dose date of Vem1 to the last dose of ipilimumab (to a maximum of 3 years) + 90 days or to the first dose date of Vem2, whichever occurred first|All participants who received at least 1 dose of study drug||Participants|||Number
672389|NCT01673854|Secondary|Percentage of Participants Who Received Ipilimumab and Who Had Grade 3-4 Drug-related Hepatobiliary Adverse Events|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Drug-related=having certain, probable, possible, or unknown relationship to study drug. Grading criteria for AEs: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death.|From the first dose date of Vem1 to the last dose of ipilimumab (to a maximum of 3 years) + 90 days or to the first dose date of Vem2, whichever occurred first|All participants who received at least 1 dose of vemurafenib and ipilimumab||Percentage of participants||95% Confidence Interval|Number
672390|NCT01673854|Secondary|Percentage of Participants Who Received Ipilimumab and Who Had Grade 3-4 Drug-related Gastrointestinal Adverse Events (AEs)|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Drug-related=having certain, probable, possible, or unknown relationship to study drug. Grading criteria for AEs: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death.|From the first dose date of Vem1 to the last dose of ipilimumab (to a maximum of 3 years) + 90 days or to the first dose date of Vem2, whichever occurred first|All participants who received at least 1 dose of ipilimumab.||Percentage of participants||95% Confidence Interval|Number
672391|NCT01673854|Primary|Percentage of Participants Who Received Ipilimumab and Who Had Grade 3-4 Drug-related Skin Adverse Events (AEs)|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Drug-related=having certain, probable, possible, or unknown relationship to study drug. Grading criteria for AEs: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death.|From the first dose date of Vem1 to the last dose of ipilimumab (to a maximum of 3 years) + 90 days or to the first dose date of Vem2, whichever occurred first|All participants who received at least 1 dose of ipilimumab||Percentage of participants||95% Confidence Interval|Number
672392|NCT01673828|Primary|Extended Glasgow Outcome Scale (GOS-E) Score|GOS-E is a global scale for functional outcome that rates patient status into one of 8 levels. The minimum score is 1 and the maximum score is 8. 1 = dead; 2 = vegetative state; 3 = low severe disability; 4 = upper severe disability; 5 = low moderate disability; 6 = upper moderate disability; 7 = low good recovery; 8 = upper good recovery. GOS-E was assessed by 19 question structured interview.|6 months after injury|||GOS-E Score||Standard Deviation|Mean
672393|NCT01673802|Primary|Number of Subjects Where Hilar Cholangiocarcinomas Could be Visualized Using Gadoxetate Disodium Enhanced Dual Energy CT|CT scans were assessed for tumor visualization after use of Gadoxetate disodium|24 hrs|Number of Subjects Where Hilar Cholangiocarcinomas Could be Visualized Using Gadoxetate Disodium Enhanced Dual Energy CT||participants|||Number
672394|NCT01673698|Secondary|Weight Loss Maintenance Six Months Following Device Removal|Assess whether significantly greater than 50% of treatment subjects maintained 40% of their excess weight loss at 48 weeks.|48 weeks|By design, this trial only studied weight loss maintenance at 48 weeks of the Treatment Group who initially received a balloon during the first 24 weeks of the study.||percentage of participant|||Number
672395|NCT01673698|Primary|Treatment Group Responder Rate Dichotomized at 25% EWL|An inferential test of whether the percentage of participants in the Treatment Group with a weight loss of >25% EWL at 24 weeks was significantly greater than 35%.|24 weeks|By design, this trial only studied the weight loss responder rate of the Treatment Group subjects during the first 24 weeks of the study.||percentage of participants|||Number
672396|NCT01673698|Primary|Comparison of Treatment % Excess Weight Loss (EWL) With Control %EWL at Week 24|An inferential test of whether the difference in the mean %EWL between the Treatment and Control groups at 24 weeks was significantly greater than a superiority margin 7.5%.|Week 24|||percentage of EWL||Standard Error|Mean
672397|NCT01673620|Primary|Number of Participants Discontinuing Study Treatment Due to AEs|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of the study treatment.|Up to 2 weeks|The APaT population consisted of all randomized participants who received at least one dose of study drug.||participants|||Number
672398|NCT01673620|Primary|Number of Participants Experiencing at Least One Adverse Event (AE)|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of the study treatment.|Up to 4 weeks|The All-Patients-as-Treated (APaT) population consisted of all randomized participants who received at least one dose of study drug.||participants|||Number
672399|NCT01673594|Primary|Safety|Number of adverse events throughout the course of the study|6 Weeks|||adverse events||Standard Deviation|Mean
672403|NCT01673490|Secondary|Change From Baseline in Maximum Rate of Urinary Flow (Qmax) at the Indicated Time Points|The Qmax is used as an indicator for the diagnosis of enlarged prostate. A lower Qmax may indicate that the enlarged prostate. Qmax was assessed at Baseline (screening), Month 3 and Month 6. Change from Baseline was calculated as Qmax score at specified timepoint minus the Baseline Qmax score.|Baseline, Month 3 and Month 6|ITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.||Mililiter/seconds||Standard Deviation|Mean
672404|NCT01673490|Secondary|Change From Baseline in the International Prostate Symptom Score (IPSS) at Month 6|The IPSS is a screening tool used to assess the symptoms of prostate related disease. The IPSS questionnaire consists of seven symptoms questions including feeling of incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining and nocturia, each referring to during the last month, and each involving assignment of a score from 0 to 5 (no symptoms to almost always symptoms) for a total of maximum 35 points. IPSS total is the sum of the scores of seven questions; therefore, the possible total score ranges from 0 to 35 (0-7: Mildly symptomatic; 8-19: Moderately symptomatic; 20-35: Severely symptomatic). IPSS was assessed at Baseline and Month 6. Change from Baseline was calculated as Month 6 IPSS score- minus Baseline IPSS score.|Baseline and Month 6|ITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.||Scores on a scale||Standard Deviation|Mean
672405|NCT01673490|Primary|Free to Total PSA Ratio at the Indicated Time Points|Serum sample was collected at Screening (Baseline for participants with Free to Total PSA ratio at Month 6), and Month 6 for assessment of free to total PSA ratio. PSA is a substance produced by prostate gland, and the elevated level of PSA indicates prostate cancer or any other non-cancerous condition related to prostate. Free to total PSA ratio at Baseline for participants with free to total PSA Ratio at Month 6 and free to total PSA ratio at month 6 are presented.|Baseline, Month 6|ITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.||Ratio||Standard Deviation|Mean
672406|NCT01673490|Primary|Change From Baseline in Total Prostate -Specific Antigen (PSA) at the Indicated Time Points|Serum sample was collected at Baseline, Month 3 and Month 6 for assesment of total PSA. PSA is a substance produced by prostate gland, and the elevated level of PSA indicates prostate cancer or any other non-cancerous condition related to prostate. Change from Baseline in total PSA at Month 3 and Month 6 was calculated as value at specified visist minus Baseline value.|Baseline, Month 3 and Month 6|ITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.||Microgram per liter (ug/L)||Standard Deviation|Mean
672407|NCT01673490|Primary|Number Participants With a Negative or Positive Response at the Indicated Time Points|Urine samples were collected at Screening (SC), Month 3 (3M) and Month 6 (6M) for urinalysis laboratory assesment. Final value (FV) is defined as the latest post-Baseline value available in the study for each parameter.Urinalysis parameters included erythrocytes, glucose, ketones, leukocytes and protein. Number of participants with a negative (NEG) or positive (POS) response at the indicated time points are summarized.|Screening, Month 3 and Month 6|ITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.||Participants|||Number
672408|NCT01673490|Primary|Number of Participants With Hematology Values Shift From Normal at Baseline to Abnormal at Any Time Post-Baseline|Blood samples were collected at Screening, Month 3 (Visit 3) and Month 6 (Visit 5) for hematology laboratory assessments. Hematology parameters included basophils, leukocytes, hemoglobin (HGB), eosinophils, erythrocytes (ery), ery mean Corpuscular HGB concentration, ery mean corpuscular HGB, ery distribution width, lymphocytes, hematocrit, monocytes, neutrophils and platelets. The number of participants with a shift from normal at Baseline to abnormal at any time post-Baseline for hematology parameters are summarized.|Screening, Month 3 and Month 6|ITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.||Participants|||Number
672409|NCT01673490|Primary|Number of Participants With Clinical Chemistry Values Shift From Normal at Baseline to Abnormal at Any Time Post-Baseline|Blood samples were collected at Screening, Month 1 (Visit 1), Month 3 (Visit 3) and Month 6 (Visit 5) for chemistry laboratory assessments. Clinical chemistry parameters included alanine aminotrasferase (ALT), aspartate aminotrasferase (AST), creatinine, glucose, potassium, protein, sodium and urea. The number of participants with a shift from normal at Baseline to abnormal at any time post-Baseline for a clinical chemistry parameter are summarized.|Screening, Month 1, Month 3 and Month 6|ITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.||Participants|||Number
672410|NCT01673490|Primary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings at the Indicated Time Points|A 12 lead ECG was measured at Screening, Month 1 (Visit 1), Month 3 (Visit 3) and Month 6 (Visit 5).|Screening, Month 1, Month 3 and Month 6|ITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.||Participants|||Number
672411|NCT01673490|Primary|Number of Participants With Any Post-treatment Adverse Events (AEs) or Any Serious Adverse Event (SAEs) and Treatment-related AEs|An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product at any dose, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, and is associated with liver injury and impaired liver function.|From start of study medication until follow-up (up to 7 months)|ITT Population||Participants|||Number
672459|NCT01673178|Primary|Change From Baseline in Creatine Phosphokinase (CPK) Level at Day 15||Baseline, Day 15|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.||U/L||Full Range|Median
673514|NCT01662102|Secondary|Quality of Life (QoL)|QoL will be assessed through EORTC FACT-G and QLQ-[C]30 questionnaires, and will be compared at each specified time point between treatment arms.|Up to 7 years||||||
672412|NCT01673490|Primary|Number of Participants With Any On-treatment Adverse Events (AEs) or Any Serious Adverse Event (SAEs) and Treatment-related AEs|An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product at any dose, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, and is associated with liver injury and impaired liver function.|From start of study medication until follow-up (up to 7 months)|Intention-to-Treat (ITT) Population: all enrolled participants regardless of whether or not study treatment was administered.||Participants|||Number
672413|NCT01673425|Secondary|Serum Antibody Response to LAIV||Change from baseline in serum antibody response at 6 weeks||||||
672414|NCT01673425|Primary|IgA Antibody Titers||Change from baseline in antibody titer at 6 weeks|This study was terminated due to poor enrollment. Analyses were not conducted due to inconclusive nasal wash samples.|||||
672415|NCT01673347|Secondary|Range of Motion Dorsiflexion|Range of Motion Dorsiflexion|3-months postoperative|17 participants available to analyze at 3 months due to early allograft failure in 7 participants||degrees||Standard Deviation|Mean
672416|NCT01673347|Secondary|Range of Motion Plantarflexion|Range of Motion Plantarflexion|3-months postoperative|17 participants available to analyze at 3 months due to early allograft failure in 7 participants||degrees||Standard Deviation|Mean
672417|NCT01673347|Secondary|Pain|Pain scored on Visual Analog Scale 0-10; 0 = no pain, 10 = worst pain|3-months postoperative|17 participants available to analyze at 3 months due to early allograft failure in 7 participants||units on a scale||Standard Deviation|Mean
672418|NCT01673347|Primary|Allograft Stability|Evaluation of the MTP joint space as determined by radiographic imaging. Count of participants maintaining adequate spacing and alignment as evaluated by the surgeon.|5-years postoperative|Study terminated prior to 5-year endpoint, no participants evaluated|||||
672419|NCT01673282|Primary|The Percent Change in Ratio of Dose and Defined Daily Dose (DDD) for the Drug Load of Concomitant Anti-Epileptic Drugs (AEDs) From Baseline to the End of Observation Period (Day 0 to 6 Months)|Drug load is defined as the sum of the ratios of the actual doses divided by the defined daily dose for all concomitant AEDs.|From Baseline (Day 0) to 6 months|The analysis group for the outcome measure is the Full Analysis Set (FAS). The FAS included all patients who received at least 1 dose of Lacosamide and for whom at least 1 valid ratio of dose and DDD at Baseline and post-Baseline could be calculated.||percent change of ratio in dose||Standard Deviation|Mean
672420|NCT01673256|Primary|Assess SJM (St. Jude Medical) Confirm ICM (Implantable Cardiac Monitor) Sensitivity and Positive Predictive Values of AF Episodes of at Least 2 Minutes in Length, Utilizing the Data Collected During the Holter Recording.|"Sensitivity measures the percentage of the actual duration of AF identified by the Holter monitor (for all AF detections that are ≥2 minutes in duration observed in the study) which are correctly identified as AF by the SJM Confirm ICM.
Positive Predictive Value measures the percentage of the duration of AF detected (for all AF detections that are ≥2 minutes in duration observed in the study) by the SJM Confirm that is identified as AF by the Holter monitor."|4 days after Holter starts|||percentage||95% Confidence Interval|Number
672421|NCT01673191|Primary|Mean Change in Intraocular Pressure||3 months|||millimeters of mercury (mm Hg)||Standard Deviation|Mean
672422|NCT01673191|Primary|Mean Change in Central Retinal Thickness||3 months|||micrometers||Standard Deviation|Mean
672423|NCT01673191|Primary|Mean Change in Central Retinal Thickness||2 months|||micrometers||Standard Deviation|Mean
672424|NCT01673191|Primary|Mean Change in Central Retinal Thickness||1 month|||micrometers||Standard Deviation|Mean
672425|NCT01673191|Primary|Mean Change in Best Corrected Visual Acuity||3 months|||logMAR units||Standard Deviation|Mean
672426|NCT01673191|Primary|Mean Change in Best Corrected Visual Acuity||2 months|||logMAR units||Standard Deviation|Mean
672427|NCT01673191|Primary|Mean Change in Best Corrected Visual Acuity||1 months|||logMAR units||Standard Deviation|Mean
672428|NCT01673178|Secondary|Apparent Clearance (CL) of PF-05231023|CL is a quantitative measure of the rate at which a drug substance is removed from the body. CL was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.|0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49|PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||liter/hour (L/hr)||Standard Deviation|Geometric Mean
672429|NCT01673178|Secondary|Plasma Decay Half-Life (t1/2) of PF-05231023|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Half-Life was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.|0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49|PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||hours||Standard Deviation|Mean
672430|NCT01673178|Secondary|Average Plasma Concentration (Cav ) of PF-05231023 After the Last Dose|Cav was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.|0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49|PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||ng/mL||Standard Deviation|Geometric Mean
672431|NCT01673178|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) of PF-05231023 After Last Dose|Cmin was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.|0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49|PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||ng/mL||Standard Deviation|Geometric Mean
672432|NCT01673178|Secondary|Accumulation Ratio for Maximum Observed Plasma Concentration (Rac,Cmax) of PF-05231023|Rac was obtained from AUCtau after last dose (Day 22) divided by AUCtau after single dose (Day 1). Rac was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.|0 (pre-dose),0.5(end of infusion), 1, 2.5, 3.5, 5.5, 9.5, 11.5 hours after start of infusion on Day 1; Day 4, 0 hour (pre-dose) on Day 8; 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22; Day 24,25,29,39,49|PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||ratio||Standard Deviation|Geometric Mean
672433|NCT01673178|Secondary|Accumulation Ratio for Area Under the Curve From Time Zero to End of Dosing Interval (Rac) of PF-05231023|Rac was obtained from AUCtau after last dose (Day 22) divided by AUCtau after single dose (Day 1). Rac was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.|0 (pre-dose), 0.5 (end of infusion ), 1, 2.5, 3.5, 5.5, 9.5, 11.5 hours after start of infusion on Day 1; Day 4, 0 hour (pre-dose) on Day 8; 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22; Day 24, 25, 29|PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||ratio||Standard Deviation|Geometric Mean
672434|NCT01673178|Secondary|Maximum Observed Plasma Concentration (Cmax) of PF-05231023 After Last Dose|Cmax was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.|0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49|PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||ng/mL||Standard Deviation|Geometric Mean
672435|NCT01673178|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05231023 After Last Dose|Tmax was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.|0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49|PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||hours||Full Range|Median
672436|NCT01673178|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-05231023 After Last Dose|AUCtau was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.|0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29|PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||ng*hr/mL||Standard Deviation|Geometric Mean
672437|NCT01673178|Secondary|Maximum Observed Plasma Concentration (Cmax) of PF-05231023 After Single Dose|Cmax was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.|0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 5.5, 9.5, 11.5 hours after start of infusion on Day 1, Day 4, 0 hour (pre-dose) on Day 8|PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest.||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
672438|NCT01673178|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05231023 After Single Dose|Tmax was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.|0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 5.5, 9.5, 11.5 hours after start of infusion on Day 1, Day 4, 0 hour (pre-dose) on Day 8|PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest.||hours||Full Range|Median
672439|NCT01673178|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-05231023 After Single Dose|AUCtau was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.|0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 5.5, 9.5, 11.5 hours after start of infusion on Day 1, Day 4, 0 hours (pre-dose) on Day 8|Pharmacokinetic (PK) parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||nanogram*hour per milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
672440|NCT01673178|Primary|Number of Participants With Anti-PF-05231023 Antibodies and Neutralizing Antibodies at Day 49||Day 49|Safety analysis set included all participants who received at least 1 dose of study medication. Here “n” signifies those participants who were evaluable for specified antibodies for each arm, respectively and “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||participants|||Number
672441|NCT01673178|Primary|Number of Participants With Anti-PF-05231023 Antibodies and Neutralizing Antibodies at Day 39|Anti-PF-05231023 antibodies and neutralizing antibodies were analyzed only for participants who received PF-05231023 as per planned analysis. One sample at Day 39 was inadvertently tested for neutralizing antibody even though the corresponding anti-PF-05231023 antibody was negative.|Day 39|Safety analysis set included all participants who received at least 1 dose of study medication. Here “n” signifies those participants who were evaluable for specified antibodies for each arm, respectively and “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||participants|||Number
672442|NCT01673178|Primary|Number of Participants With Anti-PF-05231023 Antibodies and Neutralizing Antibodies at Day 1|Anti-PF-05231023 antibodies and neutralizing antibodies were analyzed only for participants who received PF-05231023 as per planned analysis. One sample at Day 1 was inadvertently tested for neutralizing antibody even though the corresponding anti-PF-05231023 antibody was negative.|Day 1|Safety Analysis Set included all participants who receive at least 1 dose of study medication. Here “n” signifies those participants who were evaluable for this measure at specified time-points for each arm, respectively||participants|||Number
672443|NCT01673178|Primary|Change From Baseline in Average Urinary Calcium and Phosphate Levels Over 24 Hours at Day 24||Day 24|Safety analysis set included all participants who received at least 1 dose of study medication. Here “n” signifies those participants who were evaluable for this measure at specified time-points for each arm, respectively||mg/24 hours||Standard Deviation|Mean
672444|NCT01673178|Primary|Average Urinary Calcium and Phosphate Levels Over 24 Hours at Baseline||Baseline|Safety analysis set included all participants who received at least 1 dose of study medication. Here “n” signifies those participants who were evaluable for this measure at specified time-points for each arm, respectively.||milligram per 24 hours (mg/24hr)||Standard Deviation|Mean
672445|NCT01673178|Primary|Percent Change From Baseline in Tartrate-resistant Acid Phosphatase Isoform 5b (TRAP 5b) Levels at Day 49||Day 49|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.||percent change||Standard Deviation|Mean
672446|NCT01673178|Primary|Percent Change From Baseline in Tartrate-resistant Acid Phosphatase Isoform 5b (TRAP 5b) Levels at Day 39||Baseline, Day 39|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.||percent change||Standard Deviation|Mean
672447|NCT01673178|Primary|Percent Change From Baseline in Tartrate-resistant Acid Phosphatase Isoform 5b (TRAP 5b) Levels at Day 25||Baseline, Day 25|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.||percent change||Standard Deviation|Mean
672448|NCT01673178|Primary|Tartrate-resistant Acid Phosphatase Isoform 5b (TRAP 5b) Levels at Baseline||Baseline|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.||units per liter (U/L)||Standard Deviation|Mean
672449|NCT01673178|Primary|Percent Change From Baseline in Blood Osteocalcin and Bone-Specific Alkaline Phosphatase Levels at Day 49||Baseline, Day 49|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.||percent change||Standard Deviation|Mean
672450|NCT01673178|Primary|Percent Change From Baseline in Blood Osteocalcin and Bone-Specific Alkaline Phosphatase Levels at Day 39||Baseline, Day 39|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.||percent change||Standard Deviation|Mean
672451|NCT01673178|Primary|Percent Change From Baseline in Blood Osteocalcin and Bone-Specific Alkaline Phosphatase Levels at Day 25||Baseline, Day 25|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.||percent change||Standard Deviation|Mean
672452|NCT01673178|Primary|Blood Osteocalcin and Bone-Specific Alkaline Phosphatase Levels at Baseline||Baseline|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.||microgram per liter (mcg/l)||Standard Deviation|Mean
672453|NCT01673178|Primary|Percent Change From Baseline Serum N-terminal Propeptides of Type 1 Collagen (PINP) and C-Telopeptide Cross-Linking of Type 1 Collagen (CTX) Levels at Day 49||Baseline, Day 49|Safety analysis set included all participants who receive at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.||percent change||Standard Deviation|Mean
672454|NCT01673178|Primary|Percent Change From Baseline in Serum N-terminal Propeptides of Type 1 Collagen (PINP) and C-Telopeptide Cross-Linking of Type 1 Collagen (CTX) Levels at Day 39||Baseline, Day 39|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.||percent change||Standard Deviation|Mean
672455|NCT01673178|Primary|Percent Change From Baseline in Serum N-terminal Propeptides of Type 1 Collagen (PINP) and C-Telopeptide Cross-Linking of Type 1 Collagen (CTX) Levels at Day 25||Baseline, Day 25|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.||percent change||Standard Deviation|Mean
672456|NCT01673178|Primary|Serum N-terminal Propeptides of Type 1 Collagen (PINP) and C-Telopeptide Cross-Linking of Type 1 Collagen (CTX) Levels at Baseline||Baseline|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.||nanogram per milliliter (NG/ML)||Standard Deviation|Mean
672457|NCT01673178|Primary|Change From Baseline in Creatine Phosphokinase (CPK) Level at Day 49||Baseline, Day 49|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.||U/L||Full Range|Median
672460|NCT01673178|Primary|Change From Baseline in Creatine Phosphokinase (CPK) Level at Day 8||Baseline, Day 8|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.||U/L||Full Range|Median
672461|NCT01673178|Primary|Creatine Phosphokinase (CPK) Level at Baseline||Baseline|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.||units per liter (U/L)||Full Range|Median
672462|NCT01673178|Primary|Change From Baseline in Phosphate Level at Day 49||Baseline, Day 49|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.||mg/dL||Full Range|Median
672463|NCT01673178|Primary|Change From Baseline in Phosphate Level at Day 25||Baseline, Day 25|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.||mg/dL||Full Range|Median
672464|NCT01673178|Primary|Change From Baseline in Phosphate Level at Day 15||Baseline, Day 15|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.||mg/dL||Full Range|Median
672465|NCT01673178|Primary|Change From Baseline in Phosphate Level at Day 8||Baseline, Day 8|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.||mg/dL||Full Range|Median
672466|NCT01673178|Primary|Phosphate Level at Baseline||Baseline|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.||milligram per deciliter (mg/dL)||Full Range|Median
672467|NCT01673178|Primary|Thyroid Stimulating Hormone (TSH) Level at Day 49||Day 49|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.||mcIU/mL||Standard Deviation|Mean
672468|NCT01673178|Primary|Thyroid Stimulating Hormone (TSH) Level at Day 39||Day 39|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.||mcIU/mL||Standard Deviation|Mean
672469|NCT01673178|Primary|Thyroid Stimulating Hormone (TSH) Level at Day 25||Day 25|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.||mcIU/mL||Standard Deviation|Mean
672470|NCT01673178|Primary|Thyroid Stimulating Hormone (TSH) Level at Day 1||Day 1|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.||mcIU/mL||Standard Deviation|Mean
672471|NCT01673178|Primary|Thyroid Stimulating Hormone (TSH) Level at Baseline|Results are reported in micro international units per milliliter (mcIU/mL).|Baseline|Safety analysis set included all participants who received at least 1 dose of study medication.||mcIU/mL||Standard Deviation|Mean
672472|NCT01673178|Primary|Number of Participants With Abnormal Physical Examinations|Physical examination included general examination and examination of head, ears, eyes, nose, mouth, throat, neck, abdomen, skin, heart, lungs, lymph nodes, and gastrointestinal and musculoskeletal and neurological system.|Baseline up to Day 49|Physical examination data reported in this study was for identification of adverse events and were reported as an adverse event in the adverse event section.|||||
672473|NCT01673178|Primary|Number of Participants With Clinically Significant Electrocardiogram Findings|Clinically significant ECG findings included PR interval >=300 milliseconds (msec) or >=25 percent (%) increase from baseline (if baseline PR interval >200 msec) or >=50% increase (if baseline PR interval less than or equal to [<=] 200 msec); QRS interval >=140 msec or >=50% increase from baseline; QT interval >=500 msec, corrected QT interval based on Fridericia’s formula (QTcF) 450 to <480 msec, 480 to <500 msec, >=500 msec or >=30 msec but <60 msec increase from baseline or >=60 msec increase from baseline.|Baseline up to Day 49|Safety analysis set included all participants who received at least 1 dose of study medication.||participants|||Number
672474|NCT01673178|Primary|Number of Participants With Clinically Significant Vital Sign Abnormalities|Criteria for clinically significant vital signs abnormalities included supine/sitting pulse rate of <40 beats per minute (bpm) or >120 bpm, supine systolic blood pressure (SBP) of <90 millimeter of mercury (mmHg), >=30 mmHg maximum increase and decrease from baseline in same posture, supine diastolic blood pressure (DBP) of <50 mmHg; >=20 mmHg maximum increase and decrease from baseline in same posture.|Baseline up to Day 49|Safety analysis set included all participants who received at least 1 dose of study medication.||participants|||Number
672475|NCT01673178|Primary|Number of Participants With Laboratory Abnormalities|Criteria for laboratory test abnormality: Hematology (hemoglobin, hematocrit, red blood corpuscles [RBC] count: less than [<]0.8*lower limit of normal [LLN], platelets: <0.5*LLN/greater than [>]1.75*upper limit of normal [ULN], leukocytes: <0.6*LLN or >1.5*ULN, lymphocytes, total neutrophils: <0.8*LLN or >1.2*ULN, basophils, eosinophil: <0.8*LLN, monocytes: >1.2*ULN); Liver Function (aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: >0.3*ULN, total protein, albumin: <0.8*LLN or >1.2*ULN); total bilirubin, direct bilirubin, indirect bilirubin: >1.5*ULN; Renal Function (blood urea nitrogen, creatinine: >1.3*ULN, uric acid: >1.2*ULN); Electrolytes (sodium: <0.95*LLN or >1.05*ULN, potassium, chloride, calcium, bicarbonate: <0.9*LLN or >1.1*ULN; creatine kinase: >2.0*ULN; glucose fasting: <0.6*LLN or >1.5*ULN, urine white blood corpuscles [WBC] and RBC: greater than or equal to (>=) 20/High Power Field [HPF]).|Baseline up to Day 49|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.||participants|||Number
672573|NCT01671748|Secondary|Change in Ulcer Pain Between Week 5 (Randomisation) and Week 13 (Exit)|Pain was scored by each patient on a visual analogue score (VAS) from 0 to 100. A VAS score of 0 indicated no pain whilst a VAS score of 100 indicated worst possible pain. Change in pain scores were calculated by subtracting week 5 values from week 13 values.|Weeks 5 to 13|||scores on a scale||Standard Deviation|Mean
672476|NCT01673178|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events were between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.|Baseline up to 28 days after last dose|Safety analysis set included all participants who received at least 1 dose of study medication.||participants|||Number
672477|NCT01673126|Secondary|Influence of Time Since Insult on the Results||participants will be followed for the duration of 1 year||||||
672478|NCT01673126|Secondary|Influence of Etiology on the Results||participants will be followed for the duration of 1 year||||||
672479|NCT01673126|Secondary|Influence of Diagnosis on the Results||participants will be followed for the duration of 1 year||||||
672480|NCT01673126|Primary|Change in CRS-R Total Scores|"At the group level, assess the modification of CRS-R total scores in anodal tDCS as compared to sham stimulation in VS/UWS and MCS populations
The Coma Recovery Scale Revised (CRS-R) is a behavioral scale performed at the patient's bedside. It consists of 23 hierarchically arranged items that comprise 6 subscales addressing auditory, visual, motor, verbal, communication, and arousal functions.
Scoring is based on the presence or absence of specific behavioral responses to sensory stimuli administered in a standardized manner. Maximum scores of each subscale are summed to obtain the total score (from 0 to 23).
The lowest item on each subscale represents reflexive activity, whereas the highest items represent cognitively mediated behaviors."|Baseline and directly after the tDCS (20 minutes)|||units on a scale||Standard Deviation|Mean
672481|NCT01673113|Secondary|Mechanical Detection Threshold (MDT)|MDT was evaluated using von Frey Filaments. The up-down method, which evaluates the threshold force for appearance and disappearance of a touch sensation reported by the subject, was used until 3 values were obtained. The values presented in the data table were averaged over all repeats.|48-72 hours post treatment|11 subjects were randomized to have right or left flank treated with cryolipolysis and the untreated flank served as internal control.||grams|flanks|Inter-Quartile Range|Median
672482|NCT01673113|Primary|Vibration Detection Threshold (VDT)|VDT was evaluated using a computerized vibrometer with 1cm2 contact probe placed perpendicularly on the skin (TSA-II, Medoc Inc., Ramat Yishai, Israel). This device gradually increased the vibration magnitude until the subject pressed a “stop” button to indicate when they first felt the vibration. This test was repeated 8 times. The values presented in the data table were averaged over all repeats.|within 48-72 hours after treatment|11 subjects were randomized to have right or left flank treated with cryolipolysis. The untreated flank served as the internal control.||(um/sec)|flanks|95% Confidence Interval|Mean
672483|NCT01673009|Secondary|Serum Bioactivity|The investigators will quantitate the biologic activity of patient serum on fibroblast proliferation, migration, and collagen synthesis pre and post-Gleevec (7 days and 1 month)|7 days and 1 month|unable to measure this outcome because assay became unavailable|||||
672484|NCT01673009|Primary|Percent Change From Baseline in Tumor Volume at 6 Months|Volumetric measures were performed using MRI scan analysis. Response criteria include greater than 20 percent decrease in tumor volume as responsive. Greater than 20 percent increase in tumor volume as tumor progression. Less then 20 percent increase or decrease in tumor volume is stable disease|baseline to 6 months|||percentage change of tumor volume||95% Confidence Interval|Median
672485|NCT01672996|Primary|Radiographic Densities at Selected Regions in Contrast-enhanced CT Examination by Location (Abdominal Aorta), kVp 100 and Contrast Type (Ioforminol vs Iopamidol), Concentration (Ioforminol 160 or 200) and Dose Levels (1.0, 1.5, and 2.0mL/kg).|Quantitative measurement of the radiographic density (as measured by Hounsfield Units (HU) ) at the abdominal aorta at the level of the celiac artery. The greater the contrast attenuation, the higher the HU.|Within 5 minutes after administration for either Ioforminol or Iopamidol.|Evaluted 33 subjects using 100 kilovolt peak (kVp), a measure of the maximum electrical potential in kilovolts across an x-ray. tube.||Hounsfield Units||Standard Deviation|Mean
672486|NCT01672996|Secondary|Evaluate the Overall Safety of Ioforminol and Iopamidol Injections by Recording Treatment Emergent Adverse Events (TEAE).|Recording the occurrence of treatment emergent adverse events (TEAE).|Up to 72 hours for safety monitoring post Ioforminol and Iopamidol administration.|These are the numbers of Treatment Emergent Adverse Events (TEAE) and TEAEs related to Investigational Medicinal Product (IMP).||Adverse Events|||Number
672487|NCT01672996|Primary|Radiographic Densities at Selected Regions in Contrast-enhanced CT Examination by Location (Abdominal Aorta), kVp 80 and Contrast Type (Ioforminol vs Iopamidol), Concentration (Ioforminol 160 or 200) and Dose Levels (1.0, 1.5, and 2.0mL/kg).|Quantitative measurement of the radiographic density (as measured by Hounsfield Units (HU) ) at the abdominal aorta at the level of the celiac artery. The greater the contrast attenuation, the higher the HU.|Within 5 minutes after administration for either Ioforminol or Iopamidol.|Evaluted 33 subjects using 80 kilovolt peak (kVp), a measure of the maximum electrical potential in kilovolts across an x-ray.||Hounsfield Units||Standard Deviation|Mean
672488|NCT01672983|Secondary|Percentage of Participants With End of Treatment (EOT) Response|The percentage of participants with EOT response (plasma HCV RNA level < LLOQ at week 12 for the 12-week duration arms and Week 24 for the 24-week duration arms12). The LLOQ for the assay was 25 IU/mL.|12 or 24 weeks after first dose of study drug|ITT population||percentage of participants||95% Confidence Interval|Number
672489|NCT01672983|Secondary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment (SVR12)|The percentage of participants with SVR12 (plasma HCV RNA level < LLOQ 12 weeks after the last dose of study drug). The LLOQ for the assay was 25 IU/mL.|12 weeks after last dose of study drug|ITT population||percentage of participants||95% Confidence Interval|Number
672506|NCT01672970|Secondary|Change From Baseline in Swollen Joint Count (66 Joints) at Months 3 and 6|The number of swollen joints was recorded on the joint assessment form, no swelling = 0, swelling =1, for 66 joints and were classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66.|Baseline, 3 and 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category.||joint count||Standard Deviation|Mean
672490|NCT01672983|Primary|Number of Participants With Adverse Events (AEs)|An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. A serious adverse event (SAE) is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome. AEs were rated for severity as either Mild: transient and easily tolerated; Moderate: causes discomfort and interrupts usual activities; or Severe: causes considerable interference with usual activities, may be incapacitating or life-threatening. AEs related to study drug were assessed as being either probably or possibly related by the investigator. Treatment-emergent AEs (TEAEs) were collected from the first dose of study drug administration to 30 days after last dose; SAEs were collected from the time that informed consent was obtained to 30 days after last dose.|TEAEs: up to 16 weeks for the 12-week treatment groups and up to 28 weeks for the 24-week treatment groups; SAEs: up to 65 weeks for the 12-week treatment groups and up to 77 weeks for the 24-week treatment groups.|Safety population: all participants who received at least 1 dose of study drug||participants|||Number
672491|NCT01672983|Primary|Percentage of Participants With Sustained Virologic Response 24 Weeks After Treatment (SVR24)|The percentage of participants with SVR24 (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ] 24 weeks after the last dose of study drug). The LLOQ for the assay was 25 IU/mL.|24 weeks after last dose of study drug|Intent-to-treat (ITT) population: all subjects who received at least 1 dose of study drug||percentage of participants||95% Confidence Interval|Number
672492|NCT01672970|Secondary|Change From Baseline in Particpant's Assessment of RA Morning Stiffness Assessed Using VAS at Months 3 and 6|Morning stiffness was defined by the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was as limber as he/she would be during a day involving typical activities. Morning stiffness was assessed on a 100 mm VAS, where 0= none and 100= very severe.|Baseline, 3 and 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category.||units on a scale||Standard Deviation|Mean
672493|NCT01672970|Secondary|Change From Baseline in Participant's Assessment of RA-Related Pain Using VAS at Months 3 and 6|Severity of pain was evaluated by a VAS. Participants marked on a 100 mm horizontal VAS the severity of pain that they had experienced because of their RA, ranging from 0 (no pain) to 100 (unbearable pain).|Baseline, 3 and 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category.||units on a scale||Standard Deviation|Mean
672494|NCT01672970|Secondary|Change From Baseline in Participant's Assessment of Fatigue Using VAS at Months 3 and 6|Fatigue was evaluated by a VAS. Participants marked on a 100 mm horizontal VAS the level of fatigue that they have experienced, ranging from 0 (no fatigue) to 100 (extreme fatigue).|Baseline, 3 and 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category.||units on a scale||Standard Deviation|Mean
672495|NCT01672970|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Months 3 and 6|The HAQ-DI was a participant self-reported questionnaire for assessing the extent of a participant’s functional ability. It consisted of 20 questions in 8 categories (dressing and grooming, rising, eating, walking, reach, grip, hygiene, and carrying out daily activities). Each question had 4 response options, ranging from 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. The HAQ-DI scale was an average of all the scores and ranged from 0 to 3, where higher scores represented higher disease activity.|Baseline, 3 and 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category.||units on a scale||Standard Deviation|Mean
672496|NCT01672970|Secondary|Change From Baseline in Participant Global Assessment of Disease Activity at Months 3 and 6|"The Participant's Global Assessment of Disease Activity was assessed using a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). A negative change from Baseline indicated improvement."|Baseline, 3 and 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category.||units on a scale||Standard Deviation|Mean
672497|NCT01672970|Secondary|Change From Baseline in Physician Global Assessment of Disease Activity at Months 3 and 6|"The physician's global assessment of disease activity was assessed using a 0 to 100 mm horizontal VAS by the physician. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). A negative change from Baseline indicated improvement."|Baseline, 3 and 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category.||units on a scale||Standard Deviation|Mean
672498|NCT01672970|Secondary|Percentage of Participants Who Achieved 90% Improvement in ACR (ACR90) Response|ACR response was calculated based on total joint count evaluation (28 or 66/68 joint count) and other clinical and laboratory assessments. A positive ACR90 response required at least a 90% improvement (reduction) compared to baseline in swollen joint count (66 joints) and tender joint count (68 joints) and at least 3 of the following 5 assessments: (participant’s global assessment of pain, PGH, PhGH (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale), participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity), and acute phase reactant (CRP or ESR). A reduction in the level of acute phase reactants was considered an improvement.|Baseline, 3 and 6 months|FAS population||percentage of participants||95% Confidence Interval|Number
672507|NCT01672970|Secondary|Change From Baseline in Swollen Joint Count (28 Joints) at Months 3 and 6|The number of swollen joints was recorded on the joint assessment form, no swelling = 0, swelling =1, for 28 joints and were classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 28.|Baseline, 3 and 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category.||joint count||Standard Deviation|Mean
672499|NCT01672970|Secondary|Percentage of Participants Who Achieved 70% Improvement in ACR (ACR70) Response|ACR response was calculated based on total joint count evaluation (28 or 66/68 joint count) and other clinical and laboratory assessments. A positive ACR70 response required at least a 70% improvement (reduction) compared to baseline in swollen joint count (66 joints) and tender joint count (68 joints) and at least 3 of the following 5 assessments: (participant’s global assessment of pain, PGH, PhGH (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale), participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity), and acute phase reactant (CRP or ESR). A reduction in the level of acute phase reactants was considered an improvement.|Baseline, 3 and 6 months|FAS population||percentage of participants||95% Confidence Interval|Number
672500|NCT01672970|Secondary|Percentage of Participants Who Achieved 50% Improvement in ACR (ACR50) Response|ACR response was calculated based on total joint count evaluation (28 or 66/68 joint count) and other clinical and laboratory assessments. A positive ACR50 response required at least a 50% improvement (reduction) compared to baseline in swollen joint count (66 joints) and tender joint count (68 joints) and at least 3 of the following 5 assessments: (participant’s global assessment of pain, PGH, PhGH (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale), participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity), and acute phase reactant (CRP or ESR). A reduction in the level of acute phase reactants was considered an improvement.|Baseline, 3 and 6 months|FAS population||percentage of participants||95% Confidence Interval|Number
672501|NCT01672970|Secondary|Percentage of Participants Who Achieved 20 Percent (%) Improvement in ACR (ACR20) Response|ACR response was calculated based on total joint count evaluation (28 or 66/68 joint count) and other clinical and laboratory assessments. A positive ACR20 response required at least a 20% improvement (reduction) compared to baseline in swollen joint count (66 joints) and tender joint count (68 joints) and at least 3 of the following 5 assessments: participant’s global assessment of pain, PGH, PhGH (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale), participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity), Acute phase reactant (CRP or ESR). A reduction in the level of and acute phase reactants was considered an improvement.|Baseline, 3 and 6 months|FAS population||percentage of participants||95% Confidence Interval|Number
672502|NCT01672970|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Months 3 and 6|The CDAI was a combined index for measuring disease activity in RA and used to evaluate disease activity in the absence of laboratory testing of CRP and ESR. It was the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PGH and PhGH (assessed on 0-100 mm VAS); VAS (0 = no disease activity and 100 = worst disease activity). CDAI total score = 0-76. A CDAI score of <=2.8 represented clinical remission, a score of >2.8 to <=10.0 represented low disease activity, a score of >10.0 to <=22.0 represented moderate disease activity and a score of >22.0 represented high (or severe) disease.|Baseline, 3 and 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category.||units on a scale||Standard Deviation|Mean
672503|NCT01672970|Secondary|Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Months 3 and 6|The SDAI was a combined index for measuring disease activity in RA which reflected the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PGH and physician’s global assessment (PhGH) of disease activity, assessed on 0-100 mm VAS where 0 = no disease activity and 100 = worst disease activity, and C-reactive protein (CRP) (milligrams per deciliter [mg/dL]). SDAI total score = 0-86. A SDAI score of <=3.3 represented clinical remission, a score of >3.4 to <=11.0 represented low disease activity, a score of >11 to <=26.0 represented moderate disease activity and a score of >26.0 represented high (or severe) disease.|Baseline, 3 and 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category.||units on a scale||Standard Deviation|Mean
672504|NCT01672970|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Response|Clinical response assessed as per EULAR categorical DAS28 response criteria was defined as clinically meaningful improvement at a particular time point. EULAR response was based on change from baseline (CFB) in the DAS28 score and also on the actual DAS28 score at the time point so was more reflective of the current status of the participant. The DAS28 score was a measure of the participant’s disease activity, based on the TJC (28 joints), SJC (28 joints), PGH (mm), and ESR (mm/hr). DAS28 total scores ranged from 0 to approximately 10. Scores <2.6 = best disease control and scores >5.1 = worse disease control. A negative CFB indicated clinically meaningful improvement. EULAR Good response: DAS28 <=3.2 and a CFB <-1.2. EULAR Moderate response: DAS28 >3.2 to ≤ 5.1 or a CFB < -0.6 to ≥ -1.2. EULAR No response: DAS28 ≤3.2 or CFB greater than or equal to (>=) -0.6, DAS28 >3.2 to <=5.1 or CFB >=-0.6 and DAS28 >5.1 or CFB >=-0.6.|Visit 2 (Month 1), Visit 3 (Month 2), Visit 4 (Month 3), Visit 5 (Month 4), Visit 6 (Month 5), Visit 7 (Months 6) and Visit 8 (Final Visit; within 2 weeks after 6months observation period)|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.||percentage of participants||95% Confidence Interval|Number
672505|NCT01672970|Secondary|Change From Baseline in Disease Activity Score Based on 28 Joint Count (DAS28) at Months 3 and 6|DAS28 was calculated from SJC and TJC using 28 joints count, erythrocyte sedimentation rate (ESR) (millimeter per hour [mm/hr]), and Participant’s Global Assessment (PGH) of disease activity (measured on a 0 to 100 mm Visual Analogue Scale (VAS) where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using following formula: DAS28 = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*PGH of disease activity. Total score range: 0-10, higher score=more disease activity. DAS28 <3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission.|Baseline, 3 and 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category.||units on a scale||Standard Deviation|Mean
672570|NCT01671748|Primary|Actual Change in Wound Area|Wound area is measured weekly using a digital wound imaging device. The wound boundary is digitally traced by a blinded assessor. Percentage and actual change in wound area between start of treatment (week 5) and end of treatment (week 13) is evaluated.|Week 5 to 13|As previous||cm2||Standard Deviation|Mean
672508|NCT01672970|Secondary|Change From Baseline in Tender Joint Count (68 Joints) at Months 3 and 6|The number of tender joints was recorded on the joint assessment form, no tenderness = 0, tenderness = 1, for 68 joints and joints were classified as tender/not tender giving a total possible tender joint count score of 0 to 68.|Baseline, 3 and 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category.||joint count||Standard Deviation|Mean
672509|NCT01672970|Secondary|Change From Baseline in Tender Joint Count (28 Joints) at Months 3 and 6|The number of tender joints was recorded on the joint assessment form, no tenderness = 0, tenderness = 1, for 28 joints and joints were classified as tender/not tender giving a total possible tender joint count score of 0 to 28.|Baseline, 3 and 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category.||joint count||Standard Deviation|Mean
672510|NCT01672970|Secondary|Percentage of Participants With Reason for DMARD Withdrawal|Objective intolerance was determined by medical observation; subjective intolerance was determined by the participant; lack of efficacy was determined by physician discretion.|6 months|FAS population. Here number of participants analyzed = participants available for the analysis of this outcome measure.||percentage of participants|||Number
672511|NCT01672970|Secondary|Percentage of Participants on Tocilizumab Monotherapy|TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations.|6 months|FAS population||percentage of participants||95% Confidence Interval|Number
672512|NCT01672970|Secondary|Percentage of Participants Adhered to the Dosing Regimen Recommended by Physician for TCZ|A participant’s adherence was calculated based on the adverse event or laboratory abnormality experienced by the participants who required dose modifications as per local TCZ label or protocol.|6 months|FAS population||percentage of participants|||Number
672513|NCT01672970|Secondary|Number of Participants With Restoration of Initial Dosing Regimen of TCZ|The number of participants who reported restoration of initial dosing regimen of TCZ for 84.00, 133.00, 158.00, 2.3.00 and 206.00 days, were reported.|6 months|Per protocol population||participants|||Number
672514|NCT01672970|Secondary|Percentage of Participants Discontinued From Tocilizumab for Safety And Efficacy Reasons|The safety variable measured the number of participants who discontinued TCZ due to adverse reactions to TCZ, and the efficacy variable measured the participants who discontinued from TCZ due to lack of efficacy according to criteria of the treating physician.|6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.||percentage of participants|||Number
672515|NCT01672970|Secondary|Mean Dosing Interval of Treatment at 6 Months|TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations.|6 months|FAS population. Here number of participants analyzed = participants available for the analysis of this outcome measure.||days||Standard Deviation|Mean
672516|NCT01672970|Secondary|Mean Dose of TCZ at 6 Months|TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations.|6 months|FAS population. Here number of participants analyzed = participants available for the analysis of this outcome measure.||milligrams per kilogram {mg/kg)||Standard Deviation|Mean
672517|NCT01672970|Secondary|Number of Participants With Reasons for Dose Modification for TCZ|Only those participants that had dose modifications were reported.|6 months|FAS population||participants|||Number
672518|NCT01672970|Secondary|Percentage of Participants With Reasons for Termination of Previous Biologic RA Treatments|Lack of efficacy was determined as per physicians' discretion. Intolerance was defined as the participant could not be treated due to safety reason (adverse events).|Baseline|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.||percentage of participants|||Number
672519|NCT01672970|Secondary|Percentage of Participants With Duration of Previous Biologic RA Treatments|The duration of previous biologic RA treatments was classified in to two categories: less than (<) 6 months and greater than (>) 6 months.|Baseline|Per protocol population included all participants who had a valid tocilizumab administration assessment at 6-month time window and without any protocol violations.||percentage of participants|||Number
672520|NCT01672970|Secondary|Number of Previous Biologic RA Treatments Received by Participants||Baseline|FAS population||biologic treatments|||Number
672521|NCT01672970|Secondary|Percentage of Participants With Reason for DMARDs Withdrawal at Baseline|DMARDs exposure was evaluated for all participants. DMARDs treatment at baseline included participants, who were receiving DMARDs when they were included in the study and discontinued at baseline and not used as concomitant medication to TCZ.|Baseline|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.||percentage of participants|||Number
672522|NCT01672970|Secondary|Percentage of Participants Who Stopped DMARDs Prior to Start of Study and at Baseline|DMARDs exposure was evaluated for all participants. “Prior DMARDs treatment” included participants, who were treated with DMARDs 8 weeks according to physician’s discretion before being included in the study. “DMARDs treatment at baseline” included participants who were receiving DMARDs when they were included in the study and continued with this concomitant medication in addition to TCZ.|Prior to study (8 weeks) to Baseline|FAS population||percentage of participants||95% Confidence Interval|Number
672523|NCT01672970|Secondary|Percentage of Participants With Systemic Manifestations of RA at Baseline|Systemic manifestations of RA at baseline included anemia, fatigue, conventional risk factor(s) for cardiovascular disease, C-reactive protein (CRP) above upper limit of normal rheumatoid nodules, rheumatoid vasculitis, and interstitial lung disease.|Baseline|FAS population||percentage of participants||95% Confidence Interval|Number
672524|NCT01672970|Primary|Percentage of Participants on TCZ Treatment at 6 Months After Treatment Initiation||6 months|FAS population||percentage of participants||95% Confidence Interval|Number
672571|NCT01671748|Secondary|Number of Non-serious Adverse Events in Each Group|Adverse events (AEs) were defined as any undesirable clinical occurrence in a subject whether it is thought to be related to the investigational device or not.|Week 5 to 13|||Number of non-serious AEs|||Number
672525|NCT01672957|Secondary|Percentage of Participants With Graft Survival|Graft survival was defined as those participants who did not experience graft loss. Graft loss defined as physical loss (nephrectomy), functional loss (necessitating maintenance dialysis for >8 weeks), re-transplant or death during the first 12 months after transplantation.|Months 1, 6, and 12|Safety population. Number of participants analyzed = participants evaluable for this outcome measure. Here 'n' signifies number of participants evaluable at specified time-points.||percentage of participants|||Number
672526|NCT01672957|Secondary|Percentage of Participants With Acute Rejection|Percentage of participants who experienced acute rejection within 1 month of transplantation, Month 2 to Month 6 after transplantation, Month 7 to Month 12 after transplantation are reported.|Baseline to Month 1, Months 2 to 6, Months 7 to 12|Safety population included all enrolled renal transplant participants who received mycophenolate mofetil containing immunosuppressive combination therapy (safety population=128). Number of participants analyzed = participants evaluable for this outcome measure. Here 'n' signifies number of participants evaluable at specified time-points.||percentage of participants|||Number
672527|NCT01672957|Secondary|Percentage of Participants Who Received Other Immunosuppressive Agents in Combination With Mycophenolate Mofetil|Participants could have received more than one other immunosuppressive agents, at the discretion of treating physician. Percentage of participants who received 1 other immunosuppressive agent, 2 other immunosuppressive agents, and 3 other immunosuppressive agents are reported.|Baseline, Months 1, 6, and 12|ITT population. Number of participants analyzed = participants evaluable for this outcome measure. Here 'n' signifies number of participants evaluable at specified time-points.||percentage of participants|||Number
672528|NCT01672957|Secondary|Mean Dose of Mycophenolate Mofetil||Baseline, Months 1, 6, and 12|ITT population. Number of participants analyzed = participants evaluable for this outcome measure. Here 'n' signifies number of participants evaluable at specified time-points.||milligrams (mg)||Standard Deviation|Mean
672529|NCT01672957|Primary|GFR at Month 12 After Transplantation|GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. A normal GFR is > 90 mL/min, although children and older people usually have a lower GFR. Lower values indicates poor kidney function. A GFR < 15 mL/min indicates kidney failure.|Month 12|ITT population. Number of participants analyzed = participants evaluable for GFR at specified time-point.||mL/min||Standard Deviation|Mean
672530|NCT01672957|Primary|GFR at Month 6 After Transplantation|GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. A normal GFR is > 90 mL/min, although children and older people usually have a lower GFR. Lower values indicates poor kidney function. A GFR < 15 mL/min indicates kidney failure.|Month 6|ITT population. Number of participants analyzed = participants evaluable for GFR at specified time-point.||mL/min||Standard Deviation|Mean
672531|NCT01672957|Primary|Glomerular Filtration Rate (GFR) at Month 1 After Transplantation|GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. A normal GFR is greater than (>) 90 mL/min, although children and older people usually have a lower GFR. Lower values indicates poor kidney function. A GFR less than (<) 15 mL/min indicates kidney failure.|Month 1|ITT population. Number of participants analyzed = participants evaluable for GFR at specified time-point.||mL/min||Standard Deviation|Mean
672532|NCT01672957|Primary|Creatinine Clearance at Month 12 After Transplantation|Creatinine clearance is an indicator of renal function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 mL/min and for females, 90-125 mL/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.|Month 12|ITT population. Number of participants analyzed = participants evaluable for creatinine clearance at specified time-point.||mL/min||Standard Deviation|Mean
672533|NCT01672957|Primary|Creatinine Clearance at Month 6 After Transplantation|Creatinine clearance is an indicator of renal function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 mL/min and for females, 90-125 mL/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.|Month 6|ITT population. Number of participants analyzed = participants evaluable for creatinine clearance at specified time-point.||mL/min||Standard Deviation|Mean
672534|NCT01672957|Primary|Creatinine Clearance at 1 Month After Transplantation|Creatinine clearance is an indicator of renal function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 milliliters per minute (mL/min) and for females, 90-125 mL/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.|Month 1|ITT population. Number of participants analyzed = participants evaluable for creatinine clearance at specified time-point.||mL/min||Standard Deviation|Mean
672535|NCT01672827|Primary|Summary of Specificity of Blinded Visual PET Image Interpretations Without Anatomic Images.|Statistical analysis of summary of sensitivity of blinded visual PET image interpretations without anatomic images. This data consists of image interpretations by 5 Readers and No subjects were dosed in this study.These Readers examined the PET images for evidence of amyloid plaque.|Post flutemetamol administration|Number of Blinded visual PET Image Interpretations from Readers 1-5. These Readers provided their interpretations without Anatomic Images who had normal Standard of Truth (SoT).||Percentage (True Negative)||95% Confidence Interval|Number
672536|NCT01672827|Secondary|Inter-Reader Agreement of PET Images Without Anatomic Images|Statistical analysis of Inter-Reader Agreement of PET Images without anatomic Images. This data consists of image interpretations by investigators and No subjects were dosed in this study.|Post Flutemetamol Injection|||Number of inter-reader agreements|||Number
672537|NCT01672827|Primary|Summary of Sensitivity of the Blinded Visual PET Image Interpretations Without Anatomic Images.|Statistical analysis of summary of the blinded visual PET Image Interpretations without Anatomic Images. This data consists of image interpretations by 5 Readers and No subjects were dosed in this study. These Readers examined the PET images for evidence of amyloid plaque.|Post flutemetamol administration|Number of Blinded visual PET Image Interpretations from Readers 1-5. These Readers provided their interpretations without Anatomic Images who had abnormal Standard of Truth (SoT).||Percentage (True Positive)||95% Confidence Interval|Number
673515|NCT01662102|Secondary|Transformation at First Progression|Transformation rate at first progression, defined as the appearance of diffuse areas of large lymphoma cells within a tumor site.|Up to 7 years||||||
672538|NCT01672788|Secondary|Metformin: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)|"Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point.
In this endpoint, the Measured values shows inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|Pharmacokinetic (PK) set: All subjects who took at least 1 dose of investigational treatment, provided at least 1 observation for at least 1 primary PK endpoint, did not have important protocol violations relevant to the evaluation of relative bioavailability, did not vomit at or before 2 times median tmax and did not use restricted medications||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
672539|NCT01672788|Primary|Metformin: Maximum Measured Concentration (Cmax)|"Maximum measured concentration of the analyte in plasma, per period.
In this endpoint, the Measured values shows inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|Pharmacokinetic (PK) set: All subjects who took at least 1 dose of investigational treatment, provided at least 1 observation for at least 1 primary PK endpoint, did not have important protocol violations relevant to the evaluation of relative bioavailability, did not vomit at or before 2 times median tmax and did not use restricted medications||ng/mL||Geometric Coefficient of Variation|Geometric Mean
672540|NCT01672788|Primary|Empa: Maximum Measured Concentration (Cmax)|"Maximum measured concentration of the analyte in plasma, per period.
In this endpoint, the Measured values shows inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|Pharmacokinetic (PK) set: All subjects who took at least 1 dose of investigational treatment, provided at least 1 observation for at least 1 primary PK endpoint, did not have important protocol violations relevant to the evaluation of relative bioavailability, did not vomit at or before 2 times median tmax and did not use restricted medications||nmol/L||Geometric Coefficient of Variation|Geometric Mean
672541|NCT01672788|Secondary|Empa: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)|"Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point.
In this endpoint, the Measured values shows inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|Pharmacokinetic (PK) set: All subjects who took at least 1 dose of investigational treatment, provided at least 1 observation for at least 1 primary PK endpoint, did not have important protocol violations relevant to the evaluation of relative bioavailability, did not vomit at or before 2 times median tmax and did not use restricted medications||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
672542|NCT01672788|Primary|Metformin: Area Under the Curve 0 to Infinity (AUC0-∞)|"Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity.
In this endpoint, the Measured values shows inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|Pharmacokinetic (PK) set: All subjects who took at least 1 dose of investigational treatment, provided at least 1 observation for at least 1 primary PK endpoint, did not have important protocol violations relevant to the evaluation of relative bioavailability, did not vomit at or before 2 times median tmax and did not use restricted medications||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
672543|NCT01672788|Primary|Empa: Area Under the Curve 0 to Infinity (AUC0-∞)|"Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity.
In this endpoint, the Measured values shows inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|Pharmacokinetic (PK) set: All subjects who took at least 1 dose of investigational treatment, provided at least 1 observation for at least 1 primary PK endpoint, did not have important protocol violations relevant to the evaluation of relative bioavailability, did not vomit at or before 2 times median tmax and did not use restricted medications||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
672544|NCT01672723|Other Pre-specified|Self-reported Physical Symptoms|"At the end of each day while on a study drug (4 days when on naltrexone and 4 days when on placebo) participants reported on their physical symptoms (headaches, dizziness/faintness, nausea, appetite increase/decrease) on a 0 (no symptoms) to 4 (very severe) scale.
Responses were averaged across study drug to evaluate a single outcome for days when participants were on naltrexone and a single outcome for days when participants were on placebo."|once a day for 8 days|||units on a scale||Standard Deviation|Mean
672545|NCT01672723|Secondary|Daily Self-reported Feelings of Social Connection|For 8 days (4 while on placebo, 4 while on naltrexone), participants were asked to think back to the last 24 hours and respond to how disconnected they felt (“I felt out of touch and disconnected from others”). Ratings were made on a 1-7 scale anchored by 'strongly disagree' and 'strongly agree.' For ease of interpretation, feelings of disconnection were reverse-coded to measure daily feelings of social connection. Thus higher numbers indicate greater feelings of connection. Responses were averaged across the 4 days that participants were on each study drug (4 while on placebo, 4 while on naltrexone).|end of day for 8 days|||units on a scale||Standard Error|Mean
672546|NCT01672723|Primary|Changes in Self-reported Feelings of Connection During Naltrexone (vs. Placebo)|Participants will read positive, loving messages from friends and family members and then rate their feelings of connection (how connected, touched, and warm they felt, α = .93, averaged to create a measure of feelings of social connection). Ratings were made on a 1-7 scale anchored by “not at all” and “very.” Higher numbers indicate greater feelings of connection in response to reading the loving messages.|participants will report on their feelings of connection during two separate lab visits, on day 4 of each drug assignment|||units on a scale||Standard Error|Mean
673892|NCT01656967|Secondary|Number of Participants With Overall Success for SGA Placement|Ease of SGA insertion is subjectively assessed by the operator on a scale from 1 to 5 (1 = extremely easy, 5 = extremely difficult).|At SGA insertion|||participants|||Number
672547|NCT01672658|Secondary|Dizziness Handicap Inventory|"A 25-item self-assessment inventory designed to evaluate the self-perceived handicapping effects imposed by dizziness. Participants complete the questionnaire only if they report dizziness.
Self-report questionnaire Quantifies the impact of dizziness on daily life by measuring self-perceived handicap Three domains: functional (9 questions, 36 points), emotional (9 questions, 36 points), and physical (7 questions, 28 points) Maximum score of 100 (28 points for physical, 36 points for emotional and 36 points for functional) to Minimum score of 0. The higher the score, the greater the perceived handicap due to dizziness Item scores are summed Answers are graded 0 (no), 2 (sometimes) and 4 (yes)"|Pre-training, mid training, post training|This data includes the participants in this study that self reported yes to dizziness. If they answered no to dizziness they did not have the scale administered to them.||Units on a scale||Standard Deviation|Mean
672548|NCT01672658|Secondary|Activities Balance Confidence Scale (ABC)|"Subjective measure of confidence in performing various ambulatory activities without falling or experiencing a sense of unsteadiness.
16-item self-report measure in which patients rate their balance confidence for performing activities. This stem is used to lead into each activity considered: How confident are you that you will not lose your balance or become unsteady when you... Items are rated on a rating scale that ranges from 0 - 100 Score of zero represents no confidence, a score of 100 represents complete confidence Overall score is calculated by adding item scores and then dividing by the total number of items"|Pre-training, mid training, post training|||units on a scale||Standard Deviation|Mean
672549|NCT01672658|Secondary|Modified Clinical Test of Sensory Organization and Balance (mCTSlB) - Eyes Open|"The mCTSIB provides the clinician with a means to quantify postural control under various sensory conditions.
The patient performance is timed for 30 seconds. Test is terminated when a subject's arms or feet change position. If a patient in unable to maintain the position for 30 seconds they are provided with 2 additional attempts.
The scores of the 3 trials are averages"|Pre-training, mid training (4 weeks), post training (8 weeks)|||sec||Standard Deviation|Mean
672550|NCT01672658|Secondary|Modified Clinical Test of Sensory Organization and Balance (mCTSlB) - Eyes Closed|"Clinical Test of Sensory Interaction and Balance (CTSIB): assesses balance under a variety of conditions including vision blocked and surface challenges.
The patient performance is timed for 30 seconds. Test is terminated when a subject's arms or feet change position. If a patient in unable to maintain the position for 30 seconds they are provided with 2 additional attempts.
The scores of the 3 trials are averages"|Pre-training, mid training, post training|||sec||Standard Deviation|Mean
672551|NCT01672658|Secondary|Six Minute Walk Test|Assesses distance walked over 6 minutes|Pre-training, mid training (4 weeks), post training (8 weeks)|||Feet||Standard Deviation|Mean
672552|NCT01672658|Secondary|10 Meter Walk Test|assesses walking speed of short duration|Pre-training, mid training (4 weeks), post training (8 weeks)|||m/s||Standard Deviation|Mean
672553|NCT01672658|Primary|Functional Gait Assessment (FGA)|"Assesses postural stability during walking tasks. This test is a modification of the Dynamic Gait Index (DGI) developed to improve reliability and decrease the ceiling effect.
10-item test that comprises 7 of the 8 items from the original DGI Eliminated 1 item from original DGI, ambulation around obstacles Added 3 new items to the original DGI, including gait with narrow base of support, ambulating backwards, and gait with eyes closed were added Each item is scored on an ordinal scale from 0 - 3, with 0 = severe impairment
= moderate impairment
= mild impairment
= normal ambulation Highest score = 30 Assessment may be performed with or without an assistive device"|Pre-training, Mid-training assessment (4 weeks), Post-training (8 weeks)|||units on a scale||Standard Deviation|Mean
672554|NCT01672658|Primary|Berg Balance Scale|The BBS is a 14-item objective measure designed to assess static balance and fall risk in adult populations and is a well-accepted measure in the stroke literature. The functional activities that are assessed include sitting and standing balance during transfers, altered base of support, reaching, turning, eyes open and closed. Each item is scored from 0 to 4 points. The maximum score is 56 points. A score from 0 to 20 represents balance impairment, 21 to 40 represents acceptable balance, and 41-56 represents good balance.|Pre-training,Midpoint Assessment (4 weeks), Post Training (8 weeks)|||Units on a continuous scale||Standard Deviation|Mean
672555|NCT01672294|Secondary|Caregiver Preparation|Quality of life at the End of Life (Family Edition) is a 17-item measure of quality of life at the end of life assessing five domains: life completion, relationship with health care providers, preparation for death, physical symptoms and affective social support. The 5-item preparation subscale uses a 5 point (0-4) Likert scale. The subscale ranges from 0 (poor) to 4 (better outcome).|Measured at baseline, 5 weeks, and 8 weeks|Comparing preparation scores between the Outlook Intervention and the Relaxation meditation arm, caregivers only. Two scale items were inadvertently left out initially. Items were added back in when omission was noted. However, the large number of missing makes analysis inappropriate.||units on a scale||Standard Deviation|Mean
672556|NCT01672294|Secondary|Prolonged Grief - Number of Participants With Anticipatory Grief|The Prolong Grief Disorder scale is a clinically-based diagnosis determination scale modified for this study. The components/requirements that were dropped were a) diagnosis should not be made until at least 6 months since death, and b) the disturbance is not better accounted for major depressive disorder, generalized anxiety disorder or post traumatic stress disorder. The outcome was a dichotomized variable with 1 indicating symptoms of prolonged grief are present and 0 indicating insufficient symptoms.|Measured at baseline, 5 weeks, and 8 weeks|Number of participants indicating prolonged grief across the Outlook Intervention and the Relaxation meditation arm, caregivers only. Only six percent of the sample qualified as having prolonged grief, at baseline. Therefore there was not sufficient data for statistical modeling.||participants|||Number
672557|NCT01672294|Secondary|Caregiver Completion|Quality of life at the End of Life (Family Edition) is a 17-item measure of quality of life at the end of life assessing five domains: life completion, relationship with health care providers, preparation for death, physical symptoms and affective social support. The 3-item Life Completion subscale uses a 5 point (0-4) Likert scale. The subscale ranges from 0 (poor) to 4 (better outcome).|Measured at baseline, 5 weeks, and 8 weeks|Comparing life completion scores between the Outlook Intervention and the Relaxation meditation arm, caregivers only. Differences in numbers analyzed versus group totals due to missing data.||units on a scale||Standard Deviation|Mean
672572|NCT01671748|Secondary|Incidence of Wound Infection|Median number of wound infections per patient (as demonstrated by clinical symptoms) from beginning of treatment (week 5) and end of treatment (week 13).|Weeks 5 to 13|All patients included; ITT.||Number of infections per patient||Inter-Quartile Range|Median
672558|NCT01672294|Secondary|Caregiver Burden|Caregiver Reaction Assessment (CRA). The Caregiver Reaction Assessment is a 24-item multidimensional instrument designed to measure a caregiver's reactions to caregiving for family members with a variety of chronic illnesses. The esteem subscale has 7 items with a 5 level Likert scale: 1=Strongly Disagree to 5=Strongly Agree. The score is the average of the 7 items ranging from a low score of 1 associated with negative reactions and high score of 5 with positive reactions.|Measured at baseline, 5 weeks, and 8 weeks|Comparing Caregiver reaction assessment scores between the Outlook Intervention and the Relaxation Meditation arm.Differences in numbers analyzed versus group totals due to missing data.||units on a scale||Standard Deviation|Mean
672559|NCT01672294|Secondary|Patient Days of VA Hospital Use|The number of days that a patient used either the VA emergency department (ED) or was an inpatient at a VA hospital in the 6 months following randomization. Inclusion of non-VA utilization was made unpractical due to the long delay in filing for non VA reimbursement (up to 2 years). The original variable was Day AT home, defined to be 180 days minus the days in ED or inpatient hospital. This was changed to days of use due to distribution/modeling considerations.|In the 6 months after randomization|||Days in VA hospital or ER||Standard Deviation|Mean
672560|NCT01672294|Secondary|Depression|Centers for Epidemiologic Study of Depression short form (CES-D) is a 10-item measure of depression. Items are rated on a 4 point Likert scale (0-3) with total scores ranging from 0 to 30. Higher scores indicate greater depressive symptoms|Measured at baseline, 5 weeks, and 8 weeks|Primary and secondary results are comparing caregiver scores in the two arms, not patient arms.||units on a scale||Standard Deviation|Mean
672561|NCT01672294|Secondary|Spirituality|Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT-SP) subscale. The 12-item measure assess spiritual well-being: faith, meaning, and purpose. Individual items use a 5 point likert scale (0-4). The scale minimum score is 0 (negative well being) and maximum is 48 (positive well being).|Measured at baseline, 5 weeks, and 8 weeks|Comparing spiritual well being levels between the Outlook and the Relaxation meditation arms, Caregivers only.||units on a scale||Standard Deviation|Mean
672562|NCT01672294|Primary|Caregiver Anxiety|Profile of Moods States (POMS) anxiety sub-scale The anxiety sub-scale from the modified Brief Profile of Mood States (POMS),7110 a six-item measure of psychological distress. Individual items used a 5 point Likert scale (0-4). The sub-scale minimum score was 0 and maximum was 24 (more anxious ).|Measured at baseline, 5 weeks, and 8 weeks|Comparing Caregiver anxiety levels between the Outlook and the Relaxation meditation arm. Differences in numbers analyzed versus group totals due to missing data.||units on a scale||Standard Deviation|Mean
672563|NCT01671839|Secondary|Safe Treatment|Freedom from serious adverse events directly attributable to the Cabochon System or procedure.|Treatment to 3 years|||occurence of serious adverse events|||Number
672564|NCT01671839|Secondary|Procedure Tolerability|Subject rated pain according to a 0-10 numerical rating scale. Pain scale ranges from 0 (no pain) to 10 (worst possible pain). Measure was reported as mean and standard deviation of the pain score|Treatment to 3 years|The primary analysis was based upon the complete case population (CC).||units on scale||Standard Deviation|Mean
672565|NCT01671839|Secondary|Subject Satisfaction|"Subject rated satisfaction according to a 5 point Likert scale after treatment:
Very Satisfied Satisfied Neutral Unsatisfied Very Unsatisfied"|Treatment to 3 years|The primary analysis was based upon the complete case population (CC).||percentage of subjects||95% Confidence Interval|Number
672566|NCT01671839|Secondary|Improved Appearance|"Improvement in subject's cellulite appearance according to a Global Aesthetic Improvement Scale (GAIS) evaluated by independent and blinded physician panel assessment of subject photographs taken before and 1 year after treatment. Change in the cellulite severity was rated according to 5 measures:
Very much improved: Optimal cosmetic result in the treated areas for this subject
Much improved: Marked or significant improvement in appearance of the treated areas from the initial condition
Improved: Noticeable improvement in appearance of the treated areas from the initial condition but more subtle in magnitude
No Change: The appearance of the treated areas is essentially the same as the original condition
Worse: The appearance of the treated areas is worse than the original condition"|Treatment to 3 years|The primary analysis was based upon the complete case population (CC).||percentage of subjects||95% Confidence Interval|Number
672567|NCT01671839|Secondary|Improvement in Cellulite Severity Grade|Percentage of subjects which were scored to have improvement of one grade or more in a 4 point Severity Grade (none, mild, moderate, severe) as determined by independent blinded physician assessment of subject photographs taken before and 3 year after treatment.|3-year|The primary analysis was based upon the complete case population (CC). A supportive analysis was generated on the per-protocol (PP). Best-case, worst-case and multiple imputation techniques were utilized to impute missing endpoint outcomes.||percentage of subjects||95% Confidence Interval|Number
672568|NCT01671839|Primary|Mean Change in Cellulite Severity|Achievement of ≥1 point mean reduction in the 0-5 point Cellulite Severity Scale as determined by independent physician assessment of subject photographs taken before and 3 years after treatment. Cellulite severity was graded on a 0 (no cellulite) to 5 (severe cellulite) for each subject photograph taken at baseline (before treatment) and 1 year after treatment by an independent and blinded physician panel. The primary endpoint was achievement of a mean post-treatment severity at 1-year for the study population which was a minimum of 1 point lower than the baseline severity. Paired t-test test with a critical 1–sided alpha level of 0.025 was carried out on the mean Cellulite Severity Scale (0-5) change between 3 year and baseline visits.|Treatment to 3 years|The primary analysis was based upon the complete case population (CC). A supportive analysis was generated on the per-protocol (PP). Best-case, worst-case and multiple imputation techniques were utilized to impute missing primary and powered secondary endpoint outcomes.||units on a scale||95% Confidence Interval|Mean
672569|NCT01671748|Secondary|Wound Recurrence Rate|Patients whose wound has healed (defined as 100% epithelialisation with no scab present) before or at the end of treatment will be asked 90 days after date of healing if their wound has remained closed.|90 days after time of healing|Three patients healed during the study period (one NLFU+SOC patient healed after 7 weeks and one after 8 weeks of NLFU+SOC treatment, and one patient who received standard care alone healed after 4 weeks). All three of these patients remained healed 90 days after the end of their study treatment.||Number of wounds remained healed|||Number
672758|NCT01668836|Secondary|Influence of the Sirtuin 1 System on Thromboelastography.|"For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:
- slope of clot formation dynamics"|30 days post-treatment|||"Pascal/min"||Standard Deviation|Mean
672574|NCT01671748|Secondary|Change in Overall Health Related Quality of Life (HRQoL) From Week 1 (Start) and Week 13 (Exit)|"On the first and final visit participants were invited to complete a Cardiff Wound Impact Schedule (CWIS) a validated questionnaire designed to measure the impact of chronic wounds on patient health-related quality of life (HRQoL). The overall HRQoL question asks patients to rate their overall quality of life over the past week by circling a number between 0 and 10. Low scores indicate poor quality of life, and high score indicate good quality of life. Change in HRQoL was calculated by subtracting week 1 values from week 13 values.
CWIS has been validated in the following paper: Price and Harding (2004) The Cardiff Wound Impact Schedule: the development of a condition specific questionnaire to assess health-related quality of life in patients with chronic wounds. International Wound Journal 1(1):10-17"|Week 1 (start) and week 13 (exit)|All patients were analysed by ITT||units on a scale||Inter-Quartile Range|Median
672575|NCT01671748|Primary|Percentage Change in Wound Area|Wound area is measured weekly using a digital wound imaging device. The wound boundary is digitally traced by a blinded assessor. Percentage and actual change in wound area between start of treatment (week 5) and end of treatment (week 13) is evaluated.|Week 5 to 13|All patients included in the analysis; Intention to treat (ITT); Values have been adjusted for the influence of the covariate (wound area at the start of treatment)||percentage change in wound area||Standard Deviation|Mean
672576|NCT01671605|Primary|In Vitro Lipoprotein Functions|Cholesterol efflux. Baseline and outcome measurements are the same. The cholesterol efflux was measured once using HDL isolated from CKD and control patients. There was no intervention,this assessment was performed once in each group. The measurement of cholesterol efflux is performed by an in vitro assay in cultured cells. Cells are loaded with cholesterol and maintained for 72 hours. The media of the cultured cells is then changed and the new media contains HDL from CKD or control patients. In additional cells, no HDL is added. The cells are maintained for 24 hours, and intracellular cholesterol is assessed. The cholesterol efflux represents the amount of cholesterol that was leached by HDL from each of our study groups. Thus, cells not exposed to any HDL will contain the highest intracellular cholesterol content. The amount of cholesterol in cells exposed to CKD HDL or control HDL reflects the efflux capacity of that HDL. This is expressed as percent of cholesterol removed by HDL.|Once, at enrollment|||Percentage of cholesterol content||Inter-Quartile Range|Median
672577|NCT01671488|Secondary|To Evaluate Progression-free and Overall Survival for Patients With Anal Cancer Treated With ADXS11-001, Mitomycin, 5-FU and IMRT.|"Patients terminating study treatment early prior to disease recurrence will be followed every 6 months for year 1 then annually for a total of 5 years. The follow-up portion will commence once patient comes off study or post the 2-6 week post the 4th treatment time point/visit.
Assessments were tumor evaluation via sigmoidoscopy, proctoscopy, colonoscopy or anoscope and also chest/abdomen/pelvic imaging."|Follow up and survival status at 6 months and 1 year post coming off study and annually until patient has been off for 5 years|As one patient expired prior to 6 month assessment, the total n used was 9 to assess PFS||Participants|||Count of Participants
672578|NCT01671488|Primary|To Evaluate the 6-month Clinical Complete Response Rate for Patients With Anal Cancer Treated With ADXS11-001 Mitomycin, 5-FU and IMRT.|Patients to undergo tumor evaluation assessment (via sigmoidoscopy, proctoscopy, colonoscopy or anoscope) 6 months post the start of chemotherapy/radiation.|Tumor evaluation 6 months after coming off study|Number of patient's who received treatment on study||Participants|||Count of Participants
672579|NCT01671488|Primary|To Evaluate the Safety of the Addition of ADXS11-001 to Standard Chemoradiation for Patients With Anal Cancer.|Evaluate maximal toxicities via CTCAE version 4.0 All adverse events, serious and non-serious, were captured from date of ICF through 4 weeks post treatment completion- regardless of causality.|Baseline, then prior to each ADXS11-001 and weekly during radiation. Assessments 1-2 weeks post radiation then 2-6 weeks post vaccine and off study and 30 days post treatment.|Patient's who received treatment on study||Participants|||Count of Participants
672580|NCT01671293|Secondary|Change of Baseline in Waist Circumference|Participants' waist circumference will be measured in centimeters using a measuring tape. The circumference will be measured at the highest part of the iliac crest (The Canadian Physical Activity, Fitness and Lifestyle approach, 2010)|baseline and post intervention (6 -9 months after the first phone counseling session)||||||
672581|NCT01671293|Secondary|Change of Baseline in Knowledge About Prediabetes|A self-report questionnaire was developed to measure patients' knowledge about prediabetes, the risk factors for its appearance, and its treatment (or management). Is is made up by 18 items in which the person must say whether the statement presented is true or false. In addition, the instrument measures the subjective perception of the risk of developing diabetes (one item).|baseline and post intervention (6 -9 months after the first phone counseling session)||||||
672582|NCT01671293|Secondary|Change From Baseline in Self Report of Dietary Practices|The dietary practices reported by the participants will be measured with an instrument designed with this purpose in mind as part of the present study. The instrument is constituted by 17 items aimed at measuring the frequency of healthy and unhealthy eating. It was constructed on the basis of items present in the Diabetes Self Care Activities Measure (Toobert, Hampson, & Glasgow, 2000) and of others created by the Stanford Patient Education Research Center. Some of these items were used to measure dietary practices in Chilean populations diagnosed with Diabetes Mellitus (Lange et al., 2010)|baseline and post intervention (6 -9 months after the first phone counseling session)||||||
672583|NCT01671293|Secondary|Change From Baseline in Total Cholesterol|"It will be measured through a blood sample. The samples will be processed by the Municipal Laboratory (Laboratorio Comunal), following the standard procedures established by their protocols:
Method: Colorimetric - CHOD/PAP.Equipment: Siemens Dimension RXL. Normal Range: ≤ 200 mg/dL"|baseline and post intervention (6 -9 months after the first phone counseling session)||||||
672584|NCT01671293|Secondary|Change From Baseline in Triglycerides|"It will be measured through a blood sample. The samples will be processed by the Municipal Laboratory (Laboratorio Comunal), following the standard procedures established by their protocols:
Method:Colorimetric - GPO/PAP blank glycerol. Equipment: Siemens Dimension RXL. Normal Range: ≤ 150 mg/dL."|baseline and post intervention (6 -9 months after the first phone counseling session)||||||
672585|NCT01671293|Secondary|Change From Baseline in Fasting Glucose|"Fasting Glucose will be measured through a blood sample. The samples will be processed by the Municipal Laboratory (Laboratorio Comunal), following the standard procedures established by their protocols:
Method:Colorimetric - Hexokinase / Glucose 6-phosphate-DH. UV. Equipment: Siemens Dimension RXL. Normal Range: 70-100 mg/dL."|baseline and post intervention (6 -9 months after the first phone counseling session)||||||
672586|NCT01671293|Secondary|Change From Baseline in Self Report of Physical Activity|The level of physical activity reported by participants is measured using the Rapid Assessment Physical Activity Scale (RAPA; Tolpolski et al., 2006), in its version adapted for Chile. This instrument is made up by 9 dichotomous questions, which point to a physical activity level corresponding to the following categories: sedentary, under-active, under-active regular-light activities, under-active regular, and active, depending on the frequency and intensity of the physical activity done. The instrument adaptation process of the instrument is conducted as part of the present study.|baseline and post intervention (6 -9 months after the first phone counseling session)||||||
672587|NCT01671293|Primary|Change From Baseline in Weight Parameter|Patient's weight wil be measured in kilograms using scales.|baseline and post intervention (6 -9 months after the first phone counseling session)|||kilograms||Standard Deviation|Mean
672588|NCT01671280|Secondary|Clinical Effectiveness Rate in Participants With Pelvic Inflammatory Disease|Clinical effectiveness rate in pelvic inflammatory disease (PID), which was defined as the percentage of participants who achieved clinical effectiveness over the total number of asssable effectiveness analysis population with PID, was presented along with the corresponding 2-sided 95% CI. Clinical effectiveness of Zithromac Intravenous use (and Zithromac Tablets) was determined by the physician based on clinical symptoms and laboratory findings, and assessed according to the following categories: (1) effective, (2) ineffective, or (3) unassessable.|29 days|"The effectiveness analysis set comprised of participants in the safety analysis set who had effectiveness evaluation of PID (overall evaluation by the physician based upon change in clinical symptoms and laboratory findings) at least once. Participants evaluated as unassessable were excluded from the calculation."||Percentage of Participants||95% Confidence Interval|Number
672589|NCT01671280|Secondary|Clinical Effectiveness Rate in Participants With Pneumonia|Clinical effectiveness rate in participants with pneumonia, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of asssable effectiveness analysis population with pneumonia, was presented along with the corresponding 2-sided 95% CI. Clinical effectiveness of Zithromac Intravenous use (and Zithromac Tablets) was determined by the physician based on clinical symptoms and laboratory findings, and assessed according to the following categories: (1) effective, (2) ineffective, or (3) unassessable.|29 days|"The effectiveness analysis set comprised of participants in the safety analysis set who had effectiveness evaluation of pneumonia (overall evaluation by the physician based upon change in clinical symptoms and laboratory findings) at least once. Participants evaluated as unassessable were excluded from the calculation."||Percentage of Participants||95% Confidence Interval|Number
672590|NCT01671280|Primary|Number of Participants With Treatment-Related Adverse Events|A treatment-related adverse event was any untoward medical occurrence attributed to Zithromac Intravenous use (and Zithromac Tablets) in a participant who received Zithromac Intravenous use (and Zithromac Tablets). A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to Zithromac Intravenous use (and Zithromac Tablets) was assessed by the physician.|29 days|The safety analysis set comprised of participants who satisfied the inclusion criteria and received Zithromac Intravenous use at least once.||Participants|||Number
672591|NCT01671111|Secondary|Change From Baseline in Serum Ferritin Values at Specified Visits|A negative change from baseline indicates that serum ferritin decreased. A cycle consisted of 8 standard 6-weekly visits and the cycles were repeated each year for the duration of the study.|Baseline, Weeks 24 and 48 of Cycle 1, Week 24 of Cycle 2|FAS. Here, 'n' signifies the number of FAS participants evaluable for the respective time points.||nanogram per milliliter||Standard Deviation|Mean
672592|NCT01671111|Primary|Change From Baseline in Cardiac T2* Values at Week 24 (Cycle 2)|The efficacy of SSP-004184 was assessed by determining cardiac iron load. Cardiac MRI data were collected by using T2* standard procedures and used to determine iron load. A negative change from baseline indicates that iron load increased. A cycle consisted of 8 standard 6-weekly visits and the cycles were repeated each year for the duration of the study.|Baseline, Week 24 (Cycle 2)|FAS participants evaluable for this outcome.||milliseconds||Standard Deviation|Mean
672593|NCT01671111|Primary|Change From Baseline in Cardiac T2* Values at Week 48 (Cycle 1)|The efficacy of SSP-004184 was assessed by determining cardiac iron load. Cardiac MRI data were collected by using T2* standard procedures and used to determine iron load. A negative change from baseline indicates that iron load increased. A cycle consisted of 8 standard 6-weekly visits and the cycles were repeated each year for the duration of the study.|Baseline, Week 48 (Cycle 1)|FAS participants evaluable for this outcome.||milliseconds||Standard Deviation|Mean
672594|NCT01671111|Primary|Change From Baseline in Cardiac T2* Values at Week 24 (Cycle 1)|The efficacy of SSP-004184 was assessed by determining cardiac iron load. Cardiac MRI data were collected by using T2* standard procedures and used to determine iron load. A negative change from baseline indicates that iron load increased. A cycle consisted of 8 standard 6-weekly visits and the cycles were repeated each year for the duration of the study.|Baseline, Week 24 (Cycle 1)|FAS. Here, 'n' signifies the number of FAS participants evaluable for the respective time points.||milliseconds||Standard Deviation|Mean
672595|NCT01671111|Primary|Change From Baseline in Ferriscan® R2 Liver Iron Concentrations (LIC) at Week 24 (Cycle 2)|Efficacy of SSP-004184 was assessed by determining LIC. Abdominal MRI data were collected by using FerriScan R2 standard procedures and used to determine LIC. A negative change from baseline indicates that LIC decreased. A cycle consisted of 8 standard 6-weekly visits and the cycles were repeated each year for the duration of the study.|Baseline, Week 24 (Cycle 2)|FAS participants evaluable for this outcome.||mg/g dry tissue||Standard Deviation|Mean
672596|NCT01671111|Primary|Change From Baseline in Ferriscan® R2 Liver Iron Concentrations (LIC) at Week 48 (Cycle 1)|Efficacy of SSP-004184 was assessed by determining LIC. Abdominal MRI data were collected by using FerriScan R2 standard procedures and used to determine LIC. A negative change from baseline indicates that LIC decreased. A cycle consisted of 8 standard 6-weekly visits and the cycles were repeated each year for the duration of the study.|Baseline, Week 48 (Cycle 1)|FAS participants evaluable for this outcome.||mg/g dry tissue||Standard Deviation|Mean
673032|NCT01665807|Secondary|Success Rate|Successful administration, defined as being able to self-vaccinate (or for RN to provide vaccine) on the first attempt. Will be calculated using the number of participants who are successful divided by the number of participants randomized to group.|Vaccination (Day 0)|||participants|||Number
672597|NCT01671111|Primary|Change From Baseline in Ferriscan® R2 Liver Iron Concentrations (LIC) at Week 24 (Cycle 1)|Efficacy of SSP-004184 was assessed by determining LIC. Abdominal magnetic resonance imaging (MRI) data were collected by using FerriScan R2 standard procedures and used to determine LIC. A negative change from baseline indicates that LIC decreased. A cycle consisted of 8 standard 6-weekly visits and the cycles were repeated each year for the duration of the study.|Baseline, Week 24 (Cycle 1)|Full analysis set (FAS) included all participants in the Safety set who had at least 1 post-baseline primary efficacy assessment. Here, 'n' signifies the number of FAS participants evaluable for the respective time points.||milligram per gram (mg/g) dry tissue||Standard Deviation|Mean
672598|NCT01671059|Secondary|Visual Analogue Scale (VAS) for Pain|The VAS-Pain provides an overall assessment of the severity of pain that the participant is experiencing using a visual analogue score, where 0 indicates no pain and 100 indicates unbearable pain. A decrease in the score indicates improvement.|6 months|Enrolled participants who were evaluable for this outcome measure.||units on a scale||Full Range|Median
672599|NCT01671059|Secondary|Visual Analogue Scale (VAS) for Morning Stiffness|Morning stiffness was defined by the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was as limber as he/she would be during a day involving typical activities. Morning stiffness was assessed on a 100 mm VAS, where 0= none and 100= very severe.|6 months|Enrolled participants who were evaluable for this outcome measure.||units on a scale||Full Range|Median
672600|NCT01671059|Secondary|Visual Analogue Scale (VAS) for Fatigue|The VAS-fatigue provides an overall assessment of the level of fatigue that the participant is experiencing using a visual analogue score, where 0 indicates no fatigue, and 100 indicates extreme fatigue. A decrease in the score indicates improvement.|6 months|Enrolled participants who were evaluable for this outcome measure.||units on a scale||Full Range|Median
672601|NCT01671059|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI)|The HAQ is a participant self-reported questionnaire for assessing the extent of the participant’s functional ability. It consists of 20 questions in 8 categories (dressing and grooming, rising, eating, walking, reach, grip, hygiene, and carrying out daily activities). Each question has 4 response options, ranging from 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. The HAQ scale is an average of all the scores and ranges from 0 to 3, where higher scores represent higher disease activity.|6 months|Enrolled participants who were evaluable for this outcome measure.||units on a scale||Full Range|Median
672602|NCT01671059|Secondary|Patient Global Assessment of Disease Activity Score|The Patient Global Assessment of disease activity provides an overall assessment of how RA affects the participant using a visual analogue score, where 0 indicates they are managing very well and 100 indicates they are managing very poorly. A decrease in the score indicates improvement.|6 months|Enrolled participants who were evaluable for this outcome measure.||units on a scale||Full Range|Median
672603|NCT01671059|Secondary|Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESIs)|An AESI includes serious/medically significant infections; opportunistic infections; cases of elevated alanine aminotransferase (ALT) and aspartate aminotransferase (AST), in combination with either elevated bilirubin or clinical jaundice; suspected transmission of an infectious agent by the study drug; myocardial infarction /acute coronary syndrome; gastrointestinal perforations; malignancies; anaphylaxis / hypersensitivity reactions (including injection site reactions); demyelinating disorders; stroke; serious/medically significant bleeding events; or serious/medically significant hepatic events.|6 months|Enrolled participants.||percentage of participants|||Number
672604|NCT01671059|Secondary|Percentage of Participants With American College of Rheumatology (ACR) Response|ACR response was calculated based on total joint count evaluation and other clinical and laboratory assessments. A positive ACR20 response required at least a 20% improvement (reduction) compared to baseline in swollen joint count (28 joints) and tender joint count (28 joints) and at least 3 of the following 5 assessments: patient's global assessment of pain, participant's global assessment of disease activity (PGH), physician's global assessment of disease activity (PhGH) (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale); participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity); acute phase reactant (CRP or ESR). A reduction in the level of and acute phase reactants was considered an improvement. ACR50 and ACR70 require a 50% and 70% improvement from baseline, respectively.|6 months|Enrolled participants who were evaluable for this outcome measure.||percentage of participants|||Number
672605|NCT01671059|Secondary|Clinical Disease Activity Index (CDAI) Score|Clinical Disease Activity Index (CDAI) is an index for measuring disease activity in RA. The index was calculated using the following formula: CDAI = number of swollen joints using the 28-joint count (SJC28) + number of tender joints using the 28-joint count (TJC28) + patient global assessment of disease (PGA) based on 10 centimeter [cm] Visual Analog Scale [VAS] + physician global assessment of disease (PhGA) based on 10 cm VAS. VAS assessments involved a 10 cm horizontal scale from 0 (no disease activity) to 10 (maximum disease activity). Total CDAI scores range from 0 to 76, with higher scores indicating increased disease activity.|6 months|Enrolled participants who were evaluable for this outcome measure.||units on a scale||Full Range|Median
672606|NCT01671059|Secondary|Simplified Disease Activity Index (SDAI)|Simplified Disease Activity Index (SDAI) is an index for measuring disease activity in RA and has a good correlation with the DAS28. The index is calculated using the following formula: SDAI: swollen joint count (SJC28) + tender joint count (TJC28) + physician global assessment (PGA) (10 cm visual analogue scale [VAS]) + PhGA (10 cm VAS + C-Reactive Protein (CRP) in milligrams/liter (mg/L). VAS assessments involved a 10 cm horizontal scale from 0 (no disease activity) to 10 (maximum disease activity). Scores range from 0 to 86, with higher scores also indicating increased disease activity.|6 months|Enrolled participants who were evaluable for this outcome measure.||units on a scale||Full Range|Median
672624|NCT01670825|Secondary|Severe Headache Frequency for Migraine Headaches 3 Months After the Start of Treatment Measured Asking the Number of Severe Headache Days 1 Week Prior to Study Visit|This outcome will measure the number of days the patient has severe migraine headaches in the week (7 days) prior to the 3 month follow-up visit. A severe headache is defined as a headache with a score greater than or equal to 7 on the numeric pain scale.|From baseline to 3 months after the start of treatment|||days||Standard Deviation|Mean
673893|NCT01656967|Secondary|Number of Participants in Whom ETT Insertion Was Successful on the First Attempt||At ETT insertion|||participants|||Number
672607|NCT01671059|Secondary|Percentage of Participants on Monotherapy Achieving a Response by European League Against Rheumatism (EULAR) Category|Percentage of participants achieving a response by EULAR category, including moderate, good, or no response. The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good response: change from baseline <-1.2 with a DAS28 score ≤3.2; Moderate response: change from baseline <-1.2 with DAS28 scores >3.2 to ≤ 5.1 or >5.1, or a change from baseline <-0.6 to ≥-1.2 with DAS28 scores ≤3.2 and >3.2 to ≤5.1; No response: change from baseline <-0.6 to ≥-1.2 with DAS28 score >5.1, or a change from baseline ≥-0.6 with DAS28 scores ≤3.2, >3.2 to ≤ 5.1, or >5.1.|6 months|Enrolled participants who were evaluable for this outcome measure.||percentage of participants|||Number
672608|NCT01671059|Secondary|Percentage of Participants on Combination Therapy Achieving a Response by European League Against Rheumatism (EULAR) Category|Percentage of participants achieving a response by EULAR category, including moderate, good, or no response. The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good response: change from baseline <-1.2 with a DAS28 score ≤3.2; Moderate response: change from baseline <-1.2 with DAS28 scores >3.2 to ≤ 5.1 or >5.1, or a change from baseline <-0.6 to ≥-1.2 with DAS28 scores ≤3.2 and >3.2 to ≤5.1; No response: change from baseline <-0.6 to ≥-1.2 with DAS28 score >5.1, or a change from baseline ≥-0.6 with DAS28 scores ≤3.2, >3.2 to ≤ 5.1, or >5.1.|6 months|Enrolled participants who were evaluable for this outcome measure.||percentage of participants|||Number
672609|NCT01671059|Secondary|Disease Activity Score Based on 28-Joint Count (DAS28)|DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate (ESR; in millimeters per hour [mm/hour]) and global health assessment (participant-rated global assessment of disease activity using 10-mm visual analog assessment [VAS]); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity.|6 months|Enrolled participants who were evaluable for this outcome measure.||units on a scale||Full Range|Median
672610|NCT01671059|Secondary|Percentage of Participants on Tocilizumab Monotherapy at Study Entry||6 months|Enrolled participants who were evaluable for this outcome measure.||percentage of participants|||Number
672611|NCT01671059|Secondary|Percentage of Participants Discontinued From Tocilizumab for Safety Versus Efficacy||6 months|Enrolled participants.||percentage of participants|||Number
672612|NCT01671059|Secondary|Percentage of Participants With Dose Interruptions||6 months|Enrolled participants.||percentage of participants|||Number
672613|NCT01671059|Secondary|Reasons for Dose Modifications||6 months|Enrolled participants who were evaluable for this outcome measure.||participants|||Number
672614|NCT01671059|Secondary|Percentage of Participants Receiving Tocilizumab After Failing Other Biologic Agents||Baseline|Enrolled participants.||percentage of participants|||Number
672615|NCT01671059|Secondary|Percentage of Participants Receiving Tocilizumab After Failing Disease-Modifying Anti-Rheumatic Drugs (DMARDs)||6 months|Enrolled participants who were evaluable for this outcome measure.||percentage of participants|||Number
672616|NCT01671059|Secondary|Percentage of Participants With Dose Modifications||6 months|Enrolled participants.||percentage of participants|||Number
672617|NCT01671059|Primary|Percentage of Participants on Tocilizumab 6 Months After Treatment Initiation||6 months|Enrolled participants.||percentage of participants|||Number
672618|NCT01670825|Secondary|Disability Due to Headaches 6 Months After the Start of Treatment Measured Using the Headache Impact Scale|This outcome measures what the patient feels they cannot do because headaches. This outcome is measured using the Headache Impact Test. Scores in this test range from range from 36 to 78, with higher scores indicating greater negative impact. A score of less than 50 indicates minimal impact, while a score greater than or equal to 60 indicates headaches are severely impacting one's life.|From baseline to 6 months after the start of treatment|||units on a scale||Standard Deviation|Mean
672619|NCT01670825|Secondary|Disability Due to Headaches 3 Months After the Start of Treatment Measured Using the Headache Impact Scale|This outcome measures what the patient feels they cannot do because headaches. This outcome is measured using the Headache Impact Test. Scores in this test range from range from 36 to 78, with higher scores indicating greater negative impact. A score of less than 50 indicates minimal impact, while a score greater than or equal to 60 indicates headaches are severely impacting one's life.|From baseline to 3 months after the start of treatment|||units on a scale||Standard Deviation|Mean
672620|NCT01670825|Secondary|Disability Due to Headaches 6 Weeks After the Start of Treatment Measured Using the Headache Impact Scale|This outcome measures what the patient feels they cannot do because headaches. This outcome is measured using the Headache Impact Test. Scores in this test range from range from 36 to 78, with higher scores indicating greater negative impact. A score of less than 50 indicates minimal impact, while a score greater than or equal to 60 indicates headaches are severely impacting one's life.|From baseline to 6 weeks after the start of treatment|||units on a scale||Standard Deviation|Mean
672621|NCT01670825|Secondary|Severe Headache Frequency for Occipital Neuralgia Headaches 6 Months After the Start of Treatment Measured Asking the Number of Severe Headache Days 1 Week Prior to Study Visit|This outcome will measure the number of days the patient has severe occipital neuralgia headaches in the week (7 days) prior to the 6 week follow-up visit. A severe headache is defined as a headache with a score greater than or equal to 7 on the numeric pain scale.|From baseline to 6 months after the start of treatment|||days||Standard Deviation|Mean
672622|NCT01670825|Secondary|Severe Headache Frequency for Migraine Headaches 6 Months After the Start of Treatment Measured Asking the Number of Severe Headache Days 1 Week Prior to Study Visit|This outcome will measure the number of days the patient has severe migraine headaches in the week (7 days) prior to the 6 month follow-up visit. A severe headache is defined as a headache with a score greater than or equal to 7 on the numeric pain scale.|From baseline to 6 months after the start of treatment|||days||Standard Deviation|Mean
672623|NCT01670825|Secondary|Severe Headache Frequency for Occipital Neuralgia Headaches 3 Months After the Start of Treatment Measured Asking the Number of Severe Headache Days 1 Week Prior to Study Visit|This outcome will measure the number of days the patient has severe occipital neuralgia headaches in the week (7 days) prior to the 6 week follow-up visit. A severe headache is defined as a headache with a score greater than or equal to 7 on the numeric pain scale.|3 months|||days||Standard Deviation|Mean
672625|NCT01670825|Secondary|Severe Headache Frequency for Occipital Neuralgia Headaches 6 Weeks After the Start of Treatment Measured Asking the Number of Severe Headache Days 1 Week Prior to Study Visit|This outcome will measure the number of days the patient has severe occipital neuralgia headaches in the week (7 days) prior to the 6 week follow-up visit. A severe headache is defined as a headache with a score greater than or equal to 7 on the numeric pain scale.|From baseline to 6 weeks after the start of treatment|||days||Standard Deviation|Mean
672626|NCT01670825|Secondary|Severe Headache Frequency for Migraine Headaches 6 Weeks After the Start of Treatment Measured Asking the Number of Severe Headaches in the Past Week.|This outcome will measure the number of days the patient has severe migraine headaches in the week (7 days) prior to the 6 week follow-up visit. A severe headache is defined as a headache with a score greater than or equal to 7 on the numeric pain scale.|From baseline to 6 weeks after the start of treatment|||days||Standard Deviation|Mean
672627|NCT01670825|Secondary|Change in the Severity of Depression 6 Months After the Start of Treatment Measured Using the Beck's Depression Inventory|This outcome will measure the change in severity of depression using the Beck's Depression Inventory. Scores in this inventory can range from 0 to 63. 0 being the best possible outcome and 63 being the worst possible outcome. A score between 14 and 19 indicates mild depression and a score greater than or equal 29 indicates severe depression.|From baseline to 6 months after the start of treatment|||units on a scale||Standard Deviation|Mean
672628|NCT01670825|Secondary|Change in the Severity of Depression 3 Months After the Start of Treatment Measured Using the Beck's Depression Inventory|This outcome will measure the change in severity of depression using the Beck's Depression Inventory. Scores in this inventory can range from 0 to 63. 0 being the best possible outcome and 63 being the worst possible outcome. A score between 14 and 19 indicates mild depression and a score greater than or equal 29 indicates severe depression.|From baseline to 3 months after the start of treatment|||units on a scale||Standard Deviation|Mean
672629|NCT01670825|Secondary|Change in the Severity of Depression 6 Weeks After the Start of Treatment Measured Using the Beck's Depression Inventory|This outcome will measure the change in severity of depression using the Beck's Depression Inventory. Scores in this inventory can range from 0 to 63. 0 being the best possible outcome and 63 being the worst possible outcome. A score between 14 and 19 indicates mild depression and a score greater than or equal 29 indicates severe depression.|From baseline to 6 weeks after the start of treatment|||units on a scale||Standard Deviation|Mean
672630|NCT01670825|Secondary|Change in the Presence of Insomnia 6 Months After the Start of Treatment Measured Using the Athens Insomnia Scale.|This outcome will measure the participant's perceived improvement in sleep using the Athens Insomnia Scale. Scores in this scale can range from 0 to 24. 0 being the best possible outcome and 24 being the worst possible outcome. A score greater than or equal to 6 indicates a presence of insomnia.|From baseline to 6 months after the start of treatment|||units on a scale||Standard Deviation|Mean
672631|NCT01670825|Secondary|Change in the Presence of Insomnia 3 Months After the Start of Treatment Measured Using the Athens Insomnia Scale.|This outcome will measure the participant's perceived improvement in sleep using the Athens Insomnia Scale. Scores in this scale can range from 0 to 24. 0 being the best possible outcome and 24 being the worst possible outcome. A score greater than or equal to 6 indicates a presence of insomnia.|From baseline to 3 months after the start of treatment|||units on a scale||Standard Deviation|Mean
672632|NCT01670825|Secondary|Change in the Presence of Insomnia 6 Weeks After the Start of Treatment Measured Using the Athens Insomnia Scale.|This outcome will measure the participant's perceived improvement in sleep using the Athens Insomnia Scale. Scores in this scale can range from 0 to 24. 0 being the best possible outcome and 24 being the worst possible outcome. A score greater than or equal to 6 indicates a presence of insomnia.|From baseline to 6 weeks after the start of treatment|||units on a scale||Standard Deviation|Mean
672633|NCT01670825|Primary|Change in Overall Worst Headache Pain 6 Months After the Start of Treatment|This outcome measures the change in the numeric pain scale score from baseline to 6 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.|From baseline to 6 months after the start of treatment|||units on a scale||Standard Deviation|Mean
672634|NCT01670825|Primary|Change in Overall Average Headache Pain 6 Months After the Start of Treatment|This outcome measures the change in the numeric pain scale score from baseline to 6 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.|From baseline to 6 months after the start of treatment|||units on a scale||Standard Deviation|Mean
672635|NCT01670825|Primary|Change in Overall Worst Headache Pain 3 Months After the Start of Treatment|This outcome measures the change in the numeric pain scale score from baseline to 3 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.|From baseline to 3 months after the start of treatment|||units on a scale||Standard Deviation|Mean
672636|NCT01670825|Primary|Change in Overall Average Headache Pain 3 Months After the Start of Treatment|This outcome measures the change in the numeric pain scale score from baseline to 3 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.|From baseline to 3 months after the start of treatment|||units on a scale||Standard Deviation|Mean
672637|NCT01670825|Primary|Change in Overall Worst Overall Headache Pain 6 Weeks After the Start of Treatment|This outcome measures the change in the numeric pain scale score from baseline to 6 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.|From baseline to 6 weeks after the start of treatment|||units on a scale||Standard Deviation|Mean
672739|NCT01669629|Secondary|Binocular Snellen Visual Acuity|Snellen visual acuity percentage of eyes with a visual acuity of eyesight testing at a 20/20 level or better by eye.|6-10 Days|Subjects are those who were enrolled, randomized, and completed the study per protocol. Number of subjects is total in sample due to stratification by device and binocular measurement setting only.||percentage of eyes|Participants||Number
672638|NCT01670825|Primary|Change in Overall Average Headache Pain 6 Weeks After the Start of Treatment|This outcome measures the change in the numeric pain scale score from baseline to 6 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.|From baseline to 6 weeks after the start of treatment|||units on a scale||Standard Deviation|Mean
672639|NCT01670825|Primary|Change in Overall Worst Headache Pain 2 Weeks After the Start of Treatment|This outcome measures the change in the numeric pain scale score from baseline to 2 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.|From baseline to 2 weeks after the start of treatment|||units on a scale||Standard Deviation|Mean
672640|NCT01670825|Primary|Change in Overall Average Headache Pain 2 Weeks After the Start of Treatment|This outcome measures the change in the numeric pain scale score from baseline to 2 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.|From baseline to 2 weeks after the start of treatment|||units on a scale||Standard Deviation|Mean
672641|NCT01670825|Primary|Change in Worst Occipital Pain 2 Weeks After the Start of Treatment|This outcome measures the change in the numeric pain scale score from baseline to 2 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.|From baseline to 2 weeks after the start of treatment|||units on a scale||Standard Deviation|Mean
672642|NCT01670825|Primary|Change in Average Occipital Pain 2 Weeks After the Start of Treatment|This outcome measures the change in the numeric pain scale score from baseline to 2 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.|From baseline to 2 weeks after the start of treatment|||units on a scale||Standard Deviation|Mean
672643|NCT01670825|Primary|Change in Worst Occipital Pain 3 Months After the Start of Treatment|This outcome measures the change in the numeric pain scale score from baseline to 3 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.|From baseline to 3 months after the start of treatment|||units on a scale||Standard Deviation|Mean
672644|NCT01670825|Primary|Change in Average Occipital Pain 3 Months After the Start of Treatment|This outcome measures the change in the numeric pain scale score from baseline to 3 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.|From baseline to 3 months after the start of treatment|||units on a scale||Standard Deviation|Mean
672645|NCT01670825|Primary|Change in Worst Occipital Pain 6 Months After the Start of Treatment|This outcome measures the change in the numeric pain scale score from baseline to 6 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.|From baseline to 6 months after the start of treatment|||units on a scale||Standard Deviation|Mean
672646|NCT01670825|Primary|Change in Average Occipital Pain 6 Months After the Start of Treatment|The change in the numeric pain scale score from baseline to 6 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.|From baseline to 6 months after the start of treatment|||units on a scale||Standard Deviation|Mean
672647|NCT01670825|Primary|Change in Worst Occipital Pain 6 Weeks After the Start of Treatment|The change in the numeric pain scale score from baseline to 6 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.|From baseline to 6 weeks after the start of treatment|||units on a scale||Standard Deviation|Mean
672648|NCT01670825|Primary|Change in Average Occipital Pain 6 Weeks After the Start of Treatment|The change in the numeric pain scale score from baseline to 6 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.|From baseline to 6 weeks after the start of treatment|||units on a scale||Standard Deviation|Mean
672649|NCT01670721|Secondary|Change From Baseline in HRQL EQ-5D-3L VAS Score|EQ-5D VAS was used to record a participant’s rating for his/her current health-related quality of life state and captured on a vertical VAS (0-100), where 0 = worst imaginable health state and 100 = best imaginable health state. Baseline corresponded to last evaluable assessment before treatment administration.|Pre-dose at Baseline, Day 1 of every odd cycle; and at end of treatment (30 days after last study treatment) (maximum exposure: 99 weeks)|EQ-5D analysis population: participants who signed informed consent form, had an evaluable EQ-5D questionnaire at baseline and at least one evaluable assessment post baseline and received at least part of one dose of study treatment (either Aflibercept or FOLFIRI).Here, n = number of participants with available data at specified time-points.||units on a scale||Standard Deviation|Mean
672666|NCT01670279|Primary|Incidence of Physical Examination Evaluation of Potential Clinical Significance|The physical examination evaluation was one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in the following body systems: head, ears, eyes, nose, and throat; thorax; abdomen; urogenital; extremities; neurological; and skin and mucosae.|Physical examination was performed at Screening, check-in, and discharge|Safety Sample was analyzed. Any clinically significant condition present at the post-treatment physical examination that was not present at the baseline examination was documented as an adverse event and followed to a satisfactory conclusion. There were no clinically significant physical examination findings reported in this study.||Participants|||Number
672650|NCT01670721|Secondary|Change From Baseline in HRQL European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L) Index Score|EQ-5D was a standardized HRQL questionnaire consisting of EQ-5D descriptive system and Visual Analogue Scale (VAS). EQ-5D descriptive system comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression measured on 3 levels (no problem, some problems & severe problems) within a particular EQ-5D dimension. 5 dimensional 3-level system was converted into single index utility score. Possible values for single index utility score ranged from -0.594 (severe problems in all dimensions) to 1.0 (no problem in all dimensions) on scale where 1 represented best possible health state.|Pre-dose at Baseline, Day 1 of every odd cycle; and at end of treatment (30 days after last study treatment) (maximum exposure: 99 weeks)|EQ-5D analysis population: participants who signed informed consent form, had an evaluable EQ-5D questionnaire at baseline and at least one evaluable assessment post baseline and received at least part of one dose of study treatment (either Aflibercept or FOLFIRI).Here, n = number of participants with available data at specified time-points.||units on a scale||Standard Deviation|Mean
672651|NCT01670721|Secondary|Change From Baseline in Health Related Quality of Life (HRQL) European Organization for Research and Treatment for Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)|EORTC-QLQ-C30 is a cancer-specific instrument with 30 questions for evaluation of new chemotherapy and provides an assessment of participant reported outcome dimensions. First 28 questions used 4-point scale (1=not at all,2=a little,3=quite a bit,4=very much) for evaluating 5 functional scales (physical,role,emotional,cognitive,social), 3 symptom scales (fatigue,nausea/vomiting,pain) & other single items. For each item,high score represented high level of symptomatology/problem. Last 2 questions represented participant’s assessment of overall health & quality of life, coded on 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 observed values and change from baseline for global health status (scoring of questions 29 & 30) and 5 functional scales, 3 symptom scales and other single items (scoring of questions 1 to 28). Answers were converted into grading scale, with values between 0 and 100. A high score represented a favorable outcome with a best quality of life for participant.|Pre-dose at Baseline, Day 1 of every odd cycle; and at end of treatment (30 days after last study treatment) (maximum exposure: 99 weeks)|EORTC QLQ-C30 analysis population: participants who signed informed consent form; had an evaluable QLQ-C30 questionnaire at baseline and at least one evaluable assessment post baseline and received at least part of one dose of study treatment(either Aflibercept or FOLFIRI).Here, n=number of participants with available data at specified time-points.||units on a scale||Standard Deviation|Mean
672652|NCT01670721|Primary|Percentage of Participants With Adverse Events (AEs)|Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on-treatment period. On-treatment period was defined as the time from the first dose of treatment to 30 days after the last dose of treatment (either Aflibercept or FOLFIRI). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.|Baseline upto 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure:723 days)|Safety population defined as the participants who signed the informed consent form and received at least part of one dose of study treatment.||Percentage of participants|||Number
672653|NCT01670656|Secondary|Change From Baseline in Number of Days of Ibuprofen Intake Through Cycle 2|Participants were provided with ibuprofen 400 mg tablets at the screening visit to be taken throughout the study as needed as rescue medication for treating menstrual cramping pain. The maximum daily ibuprofen dose was 3200 mg (8 tablets). Participants were instructed to take the provided ibuprofen, and no other medications, for the relief of menstrual cramping pain, and to record their ibuprofen usage in their e-Diaries.|Baseline and Day 29 to 56 (Cycle 2)|All randomized participants in whom a vaginal ring was inserted and who had at least one baseline or one post-baseline value for Number of Days of Ibuprofen Intake||Days of ibuprofen intake||95% Confidence Interval|Least Squares Mean
672654|NCT01670656|Secondary|Change From Baseline in Number of Ibuprofen Tablets Taken Through Cycle 2|Participants were provided with ibuprofen 400 mg tablets at the screening visit to be taken throughout the study as needed as rescue medication for treating menstrual cramping pain. The maximum daily ibuprofen dose was 3200 mg (8 tablets). Participants were instructed to take the provided ibuprofen, and no other medications, for the relief of menstrual cramping pain, and to record their ibuprofen usage in their e-Diaries.|Baseline and Day 29 to 56 (Cycle 2)|All randomized participants in whom a vaginal ring was inserted and who had at least one baseline or one post-baseline value for Number of Ibuprofen Tablets Taken||Ibuprofen tablets||95% Confidence Interval|Least Squares Mean
672655|NCT01670656|Secondary|Change From Baseline in Total Mean Impact Score Through Cycle 2|"Total Mean Impact Score is the mean of the sum of the daily responses to questions 6, 8, 9, and 10 in the Dysmenorrhea Daily e-Dairy, as recorded within the menstrual cramping pain analysis window. These questions assessed how much interference there was from pelvic cramping pain on work/school activities (Q6), physical activities (Q8), social/leisure activities (Q9) and sleep (Q10). Each question was rated on a 5-point (0-4) scale, with 0 being not at all, 1 slightly, 2 moderately, 3 quite a bit and 4 extremely. The total mean impact score could thus range from 0 (lowest possible impact) to 16 (highest possible impact)."|Baseline and Day 29 to 56 (Cycle 2)|All randomized participants in whom a vaginal ring was inserted and who had at least one baseline or one post-baseline value for Total Mean Impact Score||Units on a scale||95% Confidence Interval|Least Squares Mean
672667|NCT01670279|Primary|Incidence of ECG Evaluations of Potential Clinical Significance|The measurement of ECG was one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, QRS, QT, QTcB, and QTcF that were identified based on pre-defined criteria.|Titratrion Day 1 and 7, Fixed dose Day 1, 14, 28, Early Termination|The safety dataset included all randomized participants who received at least one dose of study medication.||Participants|||Number
672740|NCT01669629|Secondary|Subject Reported Overall Vision|Measured on a 5 point-scale of excellence (excellent, very good, good, fair and poor) per a participant using an aggregate summary of excellent/very good at their 1-week visit.|6-10 Days|||percentage of participants|||Number
672656|NCT01670656|Primary|Change From Baseline in Mean Menstrual Cramping Pain Score Through Cycle 2|"The Mean Menstrual Cramping Pain score was calculated as the average of the three highest daily menstrual cramping scores (item #3 of the Menstrual Distress Questionnaire: Cramps) in the baseline cycle and treatment Cycle 2, respectively. The daily menstrual cramping pain score was based on five pain categories: none (0); mild (1); moderate (2); strong (3); and severe (4). In case of absence of withdrawal bleeding, or onset of menstruation, the mean of the three highest menstrual cramping pain scores recorded within Days 21-28 was used for analysis. The Mean Menstrual Cramping Pain Score in the baseline or subsequent cycles could range from 0 (none) to 4 (severe)."|Baseline and Day 29 to 56 (Cycle 2)|All randomized participants in whom a vaginal ring was inserted and who had at least one baseline or one post-baseline value for Menstrual Cramping Pain Score||Units on a scale||95% Confidence Interval|Least Squares Mean
672657|NCT01670526|Secondary|Twelve-week Change in Beck Depression Inventory-II (BDI-II)|"Beck Depression Inventory-II (BDI-II) is a validated 21-question multiple-choice self-report inventory, one of the most widely used instruments for measuring the severity of depressive symptoms. Each answer is scored on a scale value of 0 to 3. Higher score indicates more severe depression.
To compare the differences in mean changes of BDI-II between two groups using two groups from baseline to week 12."|12 week|||units on a scale||Standard Deviation|Mean
672658|NCT01670526|Secondary|Twelve-week Change in The PTSD Symptom Checklist-Military Version (PCL-M)|"PCL-M is a validated 17-item self-report measure of DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision) symptoms of PTSD.The PCL-M asks about problems in response to stressful military experiences. Items are rated on a 5-point scale ranging from 1 (not at all) to 5 (extremely). Higher score indicates more stressful.
Comparison of difference in mean changes of PCL-M from baseline to 12-week follow-up between two groups."|12 week|||units on a scale||Standard Deviation|Mean
672659|NCT01670526|Secondary|Twelve-week Change in University of California San Diego Performance-based Skills Assessment - Brief (UPSA-B)|UPSA-B is a validated performance-based measure to evaluate the impact of rivastigmine-mediated memory improvements on the ability to perform tasks required for day-to-day functioning in two subdomains of financial management and communication. The scale goes from (0-100) and high score indicates better functions. Comparison of difference in mean changes of UPSA-B from baseline to 12-week follow-up between two groups.|12 weeks|Participants complete 12 weeks follow up included in this analysis.||units on a scale||Standard Deviation|Mean
672660|NCT01670526|Primary|Number of Participants With Demonstrated Improvement From Baseline on the Hopkins Verbal Learning Test-Revised (HVLT-R) Total Recall|The primary efficacy measure was the Hopkins Verbal Learning Test - Revised (HVLT-R) Total Recall Index. HVLT-R was administered at screen, baseline, weeks 4, and 12. The HVLT is a measure that assesses verbal learning and memory. Alternate versions of the HVLT-R were administered at each of the different time points. The test consists of 12 words which are read to participants for three consecutive trials, each trial followed by free recall. The Total Recall score is the total number of words recalled over the three trials. The primary endpoint evaluation was to compare the proportion of patients who demonstrated improvement from baseline on the HVLT-R Total Recall of at least 5-word and at week 12 between the treatment and placebo group.|week 12|||Participants|||Count of Participants
672661|NCT01670487|Primary|Pain Score on the Numeric Rating Scale (NRS)|Numeric rating scale (NRS) 0-10 : 0 (no pain) - 5 (moderate pain) - 10 (worst pain). Scores to be utilized after stream device applied and after intravenous catheter placement.|pain of intravenous catheter placement.|adults undergoing placement of an intravenous line in the emergency department||NRS||Standard Deviation|Mean
672662|NCT01670279|Primary|Change From Baseline to Study Completion in C-SSRS Score.|The C-SSRS was one of the primary parameters to measure the safety and tolerability of individual participants. Suicidality was monitored during the trial using the C-SSRS. This scale consists of a baseline evaluation that assesses the lifetime experience of the participant with suicide events and suicidal ideation and a post-baseline evaluation that focuses on suicidality since the last trial visit.|Baseline, End of Titration, Fixed dose Day 14 and 28, Day 15 and 29, Early Termination, Last Visit|Safety Sample includes all randomized participants who receive at least one dose of study medication.||Participants|||Number
672663|NCT01670279|Primary|Mean Change From Baseline to Study Completion in Abnormal Involuntary Movement Scale (AIMS) Rating Score.|EPS was one of the primary parameters to measure the safety and tolerability of individual participants. The AIMS Scale was an EPS rating scale. The AIMS is a 12 item scale. The first 10 items are rated from 0 to 4 (0=best, 4=worst). Items 11 and 12, related to dental status, have dichotomous responses, 0=no and 1=yes. The AIMS Total Score is the sum of the ratings for the first seven items. The possible total scores are from 0 to 28.|End of Titration, Day 15, Day 29, Early Termination and Last visit|Safety Sample includes all randomized participants who receive at least one dose of study medication.||Units on a scale||Standard Deviation|Mean
672664|NCT01670279|Primary|Mean Change From Baseline to Study Completion in Barnes Akathisia Global Score|EPS was one of the primary parameters to measure the safety and tolerability of individual participants. The Barnes Akathisia Rating Scale was an EPS rating scale. The Barnes Akathisia Rating Scale was used to assess the presence and severity of akathisia. This scale consists of 4 items. Only the 4th item, the Global Clinical Assessment of Akathisia, was evaluated in this trial. This item is rated on a 6 point scale, with 0 being best (absent) and 5 being worst (severe akathisia).|End of Titration, Day 15, Day 29, Early Termination and Last visit|Safety Sample includes all randomized participants who receive at least one dose of study medication.||Units on a scale||Standard Deviation|Mean
672665|NCT01670279|Primary|Mean Change From Baseline to Study Completion in Simpson-Angus Scale (SAS) Total Score|EPS was one of the primary parameters to measure the safety and tolerability of individual participants. The SAS is a rating scale used to measure EPS. The SAS scale consists of a list of 10 symptoms of parkinsonism (gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, head rotation, glabella tap, tremor, salivation, and akathisia), with each item rated from 0 to 4, with 0 being normal and 4 being the worst. The SAS Total score is sum of ratings for all 10 items, with possible Total scores from 0 to 40.|End of Titration, Day 15, Day 29, Early Termination and Last visit|Safety Sample includes all randomized participants who receive at least one dose of study medication.||Units on a scale||Standard Deviation|Mean
672741|NCT01669629|Secondary|Subject Reported Overall Comfort|Measured on a 5 point-scale of excellence (excellent, very good, good, fair and poor) per a participant. Summary is reported as an aggregate of Excellent/Very Good at their 1-week visit.|6-10 Days|||percentage of participants|||Number
672668|NCT01670279|Primary|Incidence of Vital Signs of Potential Clinical Significance|The vital signs were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance included abnormal values in heart rate, systolic and diastolic blood pressure, respiratory rate and weight that were identified based on pre-defined criteria.|Baseline, Titration Day 1, 2, 7, 8, Fixed Days 1, 2, 14, 15, 28, 29, Early Termination and Last Visit.|The safety dataset included all randomized participants who received at least one dose of study medication.||Participants|||Number
672669|NCT01670279|Primary|Incidence of Laboratory Values of Potential Clinical Significance|The laboratory values were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal values in serum chemistry, hematology, urinalyses and prolactin tests that were identified based on pre-defined criteria.|Titration Day 7, Fixed dose Day 14 and 28 and Last Visit|The safety dataset included all randomized participants who received at least one dose of study medication.||Participants|||Number
672670|NCT01670279|Primary|Number of AEs Reported.|The AEs were one of the primary parameters to measure the safety and tolerability of individual participants. The AEs were captured for all participants from the time the ICF was signed until the end of the trial. AEs were measured throughout the 14-day titration and 28-day fixed dose phase until follow-up (30 [±2] days after last dose of study medication).|Throughout the study, up to 119 days|The safety dataset included all randomized participants who received at least one dose of study medication.||Events|||Number
672671|NCT01670279|Primary|Number of Participants Who Tolerated Brexpiprazole|Safety and tolerability of brexpiprazole was noted to be primary outcome measure. Brexpiprazole was judged to be tolerated if at least 6 out of 8 (75%) of the participants in a test cohort tolerated the dose after 14 days of QD dosing at the end of the fixed dose phase based on the blinded data. Dose toleration was defined as follows: during the course of the trial, the participants did not experience any moderate or severe adverse events (AEs) or potentially clinically relevant changes from Baseline in laboratory values, vital signs, electrocardiogram (ECG) tracings, Columbia-Suicide Severity Rating Scale (C-SSRS), or extrapyramidal symptom (EPS) ratings, which were assessed as possibly related to the study drug, and would have warranted a dose decrease or discontinuation of the study drug. The safety and tolerability of brexpiprazole was defined by parameters: AEs, laboratory values, vital signs, ECG, C-SSRS, or EPS ratings, the results of each of the parameters reported separately.|45 Days|Tolerability assessed in phase 1 trial in healthy participants (18-45 years) with MDD as adjunct therapy to ADTs; the efficacy assessed in phase 3 trials in participants (18-65 years) with MDD as adjunct therapy to ADTs. Thus, safety/tolerability of brexpiprazole in participants (>65 years) with MDD as adjunct therapy to ADTs was not characterized.||participants|||Number
672672|NCT01670201|Primary|Percentage of Participants Who Had > 95 % Epithelialization at Day 10||10 days|||percentage of participants|||Number
672673|NCT01670201|Secondary|Pain at Dressing Changes|"The Medain and Full Range values are presented for all pain scores collected over multiple dressing changes, per participant, over the course of 28 Days.
Adult ( 13 years and older) patient informed about his/her pain from No pain (0) to Most intense pain (100) imaginable, by using the Visual Analogue Scale ( VAS),
Children were using the WONG baker faces, they could chose between, no hurt, hurts Little bit, hurts Little more, hurts even more hurts whole lot hurts worst."|28 days|||units on a scale VAS 0-100||Full Range|Median
672674|NCT01670045|Secondary|Percentage of Participants With Tocilizumab Dose Modifications||Baseline up to Month 6|ITT.||percentage of participants|||Number
672675|NCT01670045|Secondary|Change From Baseline in Physician Global Assessment of Disease Activity at Months 3 and 6|Physician's global assessment of disease activity over the previous 24 hours was assessed using a VAS where left end of the line 0 mm=no disease activity to right end of the line 100 mm=maximum disease activity.|Baseline, Months 3, 6|"ITT. Here number of participants analyzed included evaluable participants for the outcome measure and n included evaluable participants at specified time point."||mm||Standard Deviation|Mean
672676|NCT01670045|Secondary|Number of Participants With Reduction/Withdrawal of Disease-modifying Anti-rheumatic Drugs (DMARDs) and/or Corticosteroids|Participants with reduction/withdrawal of DMARDs and corticosteroids at baseline (before trial period) and up to Month 6 (during trial period) were reported.|Baseline, up to Month 6|ITT.||participants|||Number
672677|NCT01670045|Secondary|Percentage of Participants Achieving a Response According to ACR Criteria|ACR20/50/70 percent (%) response is defined as a ≥ 20%/50%/70% improvement (reduction) compared with baseline for both TJC28 and SJC28, as well as for three of the additional five ACR core set variables: Participant's assessment of pain over the previous 24 hours: using a VAS, left end of the line 0 cm=no pain to right end of the line 10 cm=unbearable pain; Patient's global assessment of disease activity and physician's global assessment of disease activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; health assessment questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or erythrocyte sedimentation rate].|Month 1, 2, 3, 4, 5, 6|ITT.||percentage of participants|||Number
672678|NCT01670045|Secondary|Number of Participants With Different Types of Clinical Disease Activity Index (CDAI)|The CDAI was calculated as [SJC (28 joints) + TJC (28 joints) + VAS patient global assessment of disease activity + VAS physician global assessment of disease activity]. VAS assessments: 0 cm =no disease activity to 100 cm=maximum disease activity’. CDAI scores ranged from 0 to 76, with higher scores indicating increased disease activity. CDAI score ≤ 2.8 is ‘remission’, score > 2.8 and ≤ 10 is ‘low disease activity’, score > 10 and ≤ 22 is ‘moderate disease activity’, score > 22 is ‘high disease activity’. CDAI was reported as 'not available' for participants with no data on physical/patient global assessment of disease activity.|Baseline up to Month 6|ITT.||participants|||Number
672705|NCT01669902|Secondary|Simplified Disease Activity Index (SDAI)|The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and physician global assessment (PGA) assessed on 0-10 centimeter (cm) VAS; 0 = no disease activity and 10 = worst disease activity, and CRP (mg/dL). SDAI total score = 0-86. SDAI <=3.3 indicates clinical remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high (or severe) disease activity.|Baseline, Month 3, Month 6|The FAS (SDAI) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for SDAI. n = participants evaluable for this measure at specified timepoint.||Units on a scale||Standard Deviation|Mean
672679|NCT01670045|Secondary|Number of Participants With Different Types of Simplified Disease Activity Index (SDAI)|The SDAI was calculated as [SJC (28 joints) + TJC (28 joints) + VAS patient global assessment of disease activity + VAS physician global assessment of disease activity+CRP level(milligram/deciliter {mg/dL})]. VAS assessments: 0 centimeters (cm)=no disease activity to 10 cm=maximum disease activity’. Scores ranged from 0 to 86, with higher scores also indicating increased disease activity. SDAI score ≤ 3.3 is ‘remission’, score > 3.3 and ≤ 11 is ‘low disease activity’, score > 11 and ≤ 26 is ‘moderate disease activity’, score > 26 is ‘high disease activity’. SDAI was reported as 'not available' for participants with no data on physical/patient global assessment of disease activity.|Baseline up to Month 6|ITT.||participants|||Number
672680|NCT01670045|Secondary|Number of Participants Achieving a Response According to European League Against Rheumatism (EULAR) Criteria|Response was determined using EULAR criteria based upon DAS28 absolute scores at the assessment visit and the DAS28 improvement from Baseline. Participants with a score less than or equal to (≤) 3.2 and DAS28 improvement of greater than (>) 1.2 points were assessed as having a 'good' response. Participants with a score ≤3.2 and DAS28 improvement of >0.6 to ≤1.2 points, score of >3.2 and ≤5.1 with DAS28 improvement of >0.6 to ≤1.2 points, score of >3.2 and ≤5.1 with DAS28 improvement of >1.2 points, score of >5.1 and DAS28 improvement of >1.2 points were assessed as having a 'moderate' response. Participants with a score ≤3.2 and DAS28 improvement of ≤ 0.6 points, score of >3.2 and ≤5.1 with DAS28 improvement of ≤ 0.6 points, score of >5.1 and DAS28 improvement of >0.6 to ≤1.2 points, score of >5.1 and DAS28 improvement of ≤ 0.6 points were assessed as having a 'no' response.|Baseline up to Month 6|ITT.||participants|||Number
672681|NCT01670045|Secondary|Percentage of Participants With a Reduction of at Least 2.6 Units in DAS28 From Baseline|The DAS28 score is a measure of the participants' disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], participant’s global assessment (PtGA) of disease activity [visual analog scale (VAS): 0 millimeter (mm)=no disease activity to 100 mm=maximum disease activity] and the erythrocyte sedimentation rate (ESR). DAS28 was calculated using following formulas: DAS28-ESR = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*PtGA of disease activity. A total possible score of 0 to approximately 10, with higher score indicating worse disease activity. A reduction of at least 2.6 units from Baseline in DAS28 was considered as significant clinical improvement.|Baseline, Month 1, 2, 3, 4, 5, 6|ITT.||percentage of participants|||Number
672682|NCT01670045|Secondary|Percentage of Participants With Anti-Citrullinated Cyclic Peptide (Anti-CCP) Status|"Percentage of participants with anti-CCP status were reported as positive, negative and unknown."|Baseline up to Day 5|ITT.||percentage of participants|||Number
672683|NCT01670045|Secondary|Percentage of Participants With Rheumatoid Factor Status|"Percentage of participants with rheumatoid factor status was reported as positive or negative."|Baseline up to Day 5|ITT.||percentage of participants|||Number
672684|NCT01670045|Secondary|Percentage of Participants With Different Body Mass Index (BMI)|BMI was calculated by weight divided by height squared and measured as kilogram per square meter (kg/m^2). BMI from 16 to 18.5 = underweight, BMI from 18.5 to 25= normal weight, BMI from 25 to 30= overweight, BMI from 30 to 40 = obese.|Baseline up to Day 5|ITT.||percentage of participants|||Number
672685|NCT01670045|Secondary|Percentage of Participants With RA Diagnosis|"Percentage of participants was reported based on the timing RA was diagnosed. Timings included more than 5 years, less than 5 years. Participants with unknown timing were reported under unknown."|Baseline up to Day 5|ITT.||percentage of participants|||Number
672686|NCT01670045|Primary|Percentage of Participants Who Remained on Tocilizumab Treatment at 6 Months After Treatment Initiation||Month 6|ITT.||percentage of participants|||Number
672687|NCT01670019|Secondary|Rates of Sustained Remission|"Sustained remission will be defined as at least two consecutive post-randomization assessments (weeks 2, 4, and 6) during which minimal depressive psychopathology (MADRS < 7) is present.
MADRS is a 10-item scale. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms."|2, 4, 6 weeks|Participants that completed all data collection timepoints at week 2, 4, 6.||participants|||Number
672688|NCT01670019|Secondary|Clinical Remission Rate|"Clinical Remission will be defined as the number of participants with a MADRS total score < 7.
MADRS is a 10-item scale. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms."|6 weeks|||participants|||Number
672689|NCT01670019|Secondary|Clinical Response Rate|"Clinical Response rate will be defined as the number of participants with a > 50% reduction from baseline in MADRS total score.
MADRS is a 10-item scale. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms."|Baseline, 6 weeks|||participants|||Number
672690|NCT01670019|Secondary|Study Completion Rate|The percentage of patients completing the study in their assigned treatment arm (asenapine or placebo) at the end of 6 weeks|6 weeks|||percentage of participants|||Number
672691|NCT01670019|Primary|Change in MADRS Total Score|"The Montgomery Asberg Depression Rating Scale (MADRS) is used by clinicians to assess the severity of depression among patients with a diagnosis of depression. It is designed to be sensitive to change resulting from antidepressant therapy.
MADRS is a 10-item scale. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms."|Baseline, 6 weeks|Analysis includes those participants who completed week 6 assessment.||units on a scale||Standard Deviation|Mean
672692|NCT01669902|Secondary|Number of Participants With Use of Disease-Modifying Anti-Rheumatic Drugs (DMARDs) During the Study||Baseline to Month 6|Safety Analysis Set||participants|||Number
672693|NCT01669902|Secondary|Percentage of Participants With Concomitant Corticosteroids Treatment||Baseline to Month 6|Safety Analysis Set||percentage of participants|||Number
672714|NCT01669902|Secondary|Percentage of Participants With Dose Modifications of Tocilizumab|Dose modification is any change in dose; this also included participants who stopped treatment with tocilizumab.|Baseline to Month 6|Safety Analysis Set||percentage of participants|||Number
672715|NCT01669902|Primary|Percentage of Participants on Tocilizumab Treatment at Month 6||Month 6|Safety Analysis Set||percentage of participants|||Number
673894|NCT01656967|Secondary|Number of Participants in Whom SGA Insertion Was Successful on the First Attempt||At SGA insertion|||participants|||Number
672694|NCT01669902|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Months 3 and 6|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Month 3 and Month 6|The FAS (HAQ) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for HAQ.||units on a scale||Standard Deviation|Mean
672695|NCT01669902|Secondary|Percentage of Participants With Duration of Morning Stiffness|Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness. Duration was recorded as less than (<) 30 minutes, 30 to 60 minutes, 60 to 120 minutes, 120 to 240 minutes, more than (>) 240 minutes, or whole day.|Baseline, Month 3, Month 6|FAS (morning stiffness). N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for this measure at specified timepoint.||percentage of participants|||Number
672696|NCT01669902|Secondary|Percentage of Participants With Morning Stiffness|The percentage of participants with morning stiffness (“yes”, “no”, or “do not know”) was assessed at each visit.|Baseline, Month 3, Month 6|FAS (morning stiffness) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or 6) for morning stiffness. n = participants evaluable for this measure at specified timepoint.||percentage of participants|||Number
672697|NCT01669902|Secondary|Patient Global Assessment of Pain|Patient Global Assessment of Pain was assessed using a 100 mm VAS (0 to 100) where 0 = no pain to 100 = worst possible pain.|Baseline, Month 3, Month 6|The FAS (VAS pain) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for VAS pain. n = participants evaluable for this measure at specified timepoint.||mm||Standard Deviation|Mean
672698|NCT01669902|Secondary|Percentage of Participants in a PGA of Disease Activity Score Category|A categorical scale (Lickert scale) with the following categories: none, mild, moderate, severe and maximal was used to evaluate disease activity in clinical practice.|Baseline, Month 3, Month 6|FAS (categorical scale [physician]) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for rheumatoid arthritis illness categorical scale (physician). n = participants evaluable for this measure at specified timepoint.||percentage of participants|||Number
672699|NCT01669902|Secondary|Physician Global Assessment (PGA) of Disease Activity|Physician Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity.|Baseline, Month 3, Month 6|The FAS (VAS disease activity [physician] included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for VAS disease activity (physician). n = participants evaluable for this measure at specified timepoint.||mm||Standard Deviation|Mean
672700|NCT01669902|Secondary|Patient Global Assessment (PtGA) of Disease Activity Score|Patient Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity.|Baseline, Month 3, Month 6|The FAS (VAS disease activity [patient]) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for VAS disease activity (patient). n = participants evaluable for this measure at specified timepoint.||mm||Standard Deviation|Mean
672701|NCT01669902|Secondary|Number of Participants With an American College of Rheumatology (ACR) Response|ACR response: improvement in tender or swollen joint counts and improvement in 3 of the following 5 criteria: 1) PGA of disease activity, 2) PtGA of disease activity, 3) patient's assessment of pain, 4) patient's assessment of functional disability via a health assessment questionnaire, and 5) CRP at each visit. ACR response is based on 66/68 total joint count.|Baseline to Month 6|Data for ACR response was not reported because in clinical practice the 66/68 joint evaluation needed for this is not performed in the Sweden, Denmark and Norway, the 28 joint count is performed instead.|||||
672702|NCT01669902|Secondary|Percentage of Participants Achieving Clinical Remission Based on CDAI|The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; 0 = no disease activity and 10 = worst disease activity. CDAI total score = 0-76. CDAI <= 2.8 indicates clinical remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high (or severe) disease activity.|Month 3 and Month 6|FAS (CDAI). N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for this measure at specified timepoint.||percentage of participants|||Number
672703|NCT01669902|Secondary|Clinical Disease Activity Index (CDAI)|The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; 0 = no disease activity and 10 = worst disease activity. CDAI total score = 0-76. CDAI <= 2.8 indicates clinical remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high (or severe) disease activity.|Baseline, Month 3, Month 6|The FAS (CDAI) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for CDAI. n = participants evaluable for this measure at specified timepoint.||Units on a scale||Standard Deviation|Mean
672704|NCT01669902|Secondary|Percentage of Participants Achieving Clinical Remission Based on SDAI|The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; 0 = no disease activity and 10 = worst disease activity, and CRP (mg/dL). SDAI total score = 0-86. SDAI <=3.3 indicates clinical remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high (or severe) disease activity.|Month 3 and Month 6|FAS (SDAI). N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for this measure at specified timepoint.||percentage of participants|||Number
672716|NCT01669863|Other Pre-specified|Change in Oxygenation Index During Application of ECMO|Oxygenation index (PaO2/FiO2) will be monitored regularly during the ICU stay|Duration of ICU stay|Data for this outcome were not collected. We intended to measure the PaO2/FiO2 ratio in all patients anticipating that all patients would be mechanically ventilated, either invasively or non-invasively. However, it turned out that most patients did not require mechanical ventilation while on ECMO.|||||
672717|NCT01669863|Secondary|Number of Participants Who Presented With ECMO-Related Complications|ECMO-related complications|Duration of ICU stay|||participants|||Number
672706|NCT01669902|Secondary|Percentage of Participants With EULAR Response Based on DAS28-4 (ESR)|The DAS28-4 (ESR) [described in Outcome Measure 7] based EULAR response criteria were used to measure individual response as good, moderate, or no response depending on the extent of change from baseline in DAS28 score and the level of disease activity (low, moderate or high) reached. Good responders: change from baseline >1.2 with DAS28 <= 3.2; moderate responders: change from baseline >1.2 with DAS28 in the range of >3.2 to <=5.1 or change from baseline in the range of >0.6 to <=1.2 with DAS28 in the range of >3.2 to <=5.1 or change from baseline >1.2 with DAS28 >5.1 or change from baseline in the range of >0.6 to <=1.2 with DAS28 <=3.2; non-responders: change from baseline <= 0.6 or change from baseline in the range of >0.6 to <=1.2 with DAS28 >5.1 or change from baseline <=0.6 with DAS28 <=3.2 or in the range of >3.2 to <=5.1.|Month 3 and Month 6|FAS (DAS28-4 [ESR]). N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for this measure at specified timepoint.||percentage of participants|||Number
672707|NCT01669902|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28-4 (CRP)|The DAS28-4 (CRP) [described in Outcome Measure 5] based EULAR response criteria were used to measure individual response as good, moderate, or no response depending on the extent of change from baseline in DAS28 score and the level of disease activity (low, moderate or high) reached. Good responders: change from baseline >1.2 with DAS28 <= 3.2; moderate responders: change from baseline >1.2 with DAS28 in the range of >3.2 to <=5.1 or change from baseline in the range of >0.6 to <=1.2 with DAS28 in the range of >3.2 to <=5.1 or change from baseline >1.2 with DAS28 >5.1 or change from baseline in the range of >0.6 to <=1.2 with DAS28 <=3.2; non-responders: change from baseline <= 0.6 or change from baseline in the range of >0.6 to <=1.2 with DAS28 >5.1 or change from baseline <=0.6 with DAS28 <=3.2 or in the range of >3.2 to <=5.1.|Month 3 and Month 6|FAS (DAS28-4 [CRP]). N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for this measure at specified timepoint.||percentage of participants|||Number
672708|NCT01669902|Secondary|Percentage of Participants Achieving Clinical Remission Based on DAS28-4 (ESR)|DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and PtGA of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity). DAS28-4 (ESR) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014*PtGA. Total score range: 0-10, higher score=more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = clinical remission.|Month 3 and Month 6|FAS (DAS28-4 [ESR]). N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for this measure at specified timepoint.||percentage of participants|||Number
672709|NCT01669902|Secondary|Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])|DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (millimeter per hour [mm/hour]), and PtGA of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity). DAS28-4 (ESR) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014*PtGA. Total score range: 0-10, higher score=more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = clinical remission.|Baseline, Month 3, Month 6|The FAS (DAS28-4 [ESR]) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for DAS28-4 [ESR] assessment. n = participants evaluable for this measure at specified timepoint.||Units on a scale||Standard Deviation|Mean
672710|NCT01669902|Secondary|Percentage of Participants Achieving Clinical Remission Based on DAS28-4 (CRP)|DAS28-4 (CRP) was calculated from the SJC and TJC using the 28 joints count, CRP (mg/L) and PtGA of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity). DAS28-4 (CRP) was calculated using the following formula: DAS28-4 (CRP) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014*PtGA + 0.96. Total score range: 0 to 10, higher score indicated more disease activity. DAS28-4 (CRP) <= 3.2 implied low disease activity and > 3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (CRP) < 2.6 = clinical remission.|Month 3 and Month 6|FAS (DAS28-4 [CRP]). N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for this measure at specified timepoint.||percentage of participants|||Number
672711|NCT01669902|Secondary|Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])|DAS28-4 (CRP) was calculated from the SJC and TJC using the 28 joints count, CRP (milligram per liter [mg/L]) and patient global assessment (PtGA) of disease activity (measured on a 0 to 100 millimeter [mm] Visual Analog Scale [VAS]) where 0=no disease activity and 100=worst disease activity). DAS28-4 (CRP) was calculated using the following formula: DAS28-4 (CRP) = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014*PtGA + 0.96. Total score range: 0 to 10, higher score indicated more disease activity. DAS28-4 (CRP) less than or equal to (<= 3.2) implied low disease activity and greater than (>) 3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (CRP) less than (<) 2.6 = clinical remission.|Baseline, Month 3, Month 6|The FAS (DAS28-4 [CRP]) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for DAS28-4 [CRP] assessment. n = participants evaluable for this measure at specified timepoint.||Units on a scale||Standard Deviation|Mean
672712|NCT01669902|Secondary|Tender Joint Count (TJC)|Number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1; total was calculated by adding all the joints for a maximum score of 28. A reduction in number of tender joints compared to baseline indicates improvement.|Baseline, Month 3, Month 6|The FAS (tender joint counts) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for tender joints. n = participants evaluable for this measure at specified timepoint.||tender joint count||Standard Deviation|Mean
672713|NCT01669902|Secondary|Swollen Joint Count (SJC)|Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1; total was calculated by adding all the joints for a maximum score of 28. A reduction in number of swollen joints compared to baseline indicates improvement.|Baseline, Month 3, Month 6|The Full Analysis Set (FAS) (swollen joint counts) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for swollen joints. n = participants evaluable for this measure at specified timepoint.||swollen joint count||Standard Deviation|Mean
672718|NCT01669863|Primary|Number of Participants That Did Not Require Endotrachael Intubation|- N=6 patients will be enrolled in this exploratory pilot trial; if endotracheal intubation can be avoided in 2 or more of these patients, the trial will be considered positive. In that case, the next step would be a larger trial to better define the patient population with the highest likelihood of responding to this new therapeutic concept.|Duration of ICU stay|||participants|||Number
672719|NCT01669811|Secondary|Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Sleep Disturbance at Week 4|Cumulative percentage of participants who had sustained resolution (defined as at least 7-day consecutive symptom free) of gastroesophageal reflux disease (GERD) symptom -sleep disturbance at Week 4 (on Day 29) based on the Kaplan-Meier method.|4 Weeks|Included all of the randomised participants who were definitely diagnosed to have refractory RE before the randomisation and who took at least one dose of investigational product. However, out of these participants, only participants who had the GERD symptom -sleep disturbance at baseline were included.||Percentage of participants|||Number
672720|NCT01669811|Secondary|Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Difficulty of Swallowing at Week 4|Cumulative percentage of participants who had sustained resolution (defined as at least 7-day consecutive symptom free) of gastroesophageal reflux disease (GERD) symptom -difficulty of swallowing at Week 4 (on Day 29) based on the Kaplan-Meier method.|4 Weeks|Included all of the randomised participants who were definitely diagnosed to have refractory RE before the randomisation and who took at least one dose of investigational product. However, out of these participants, only participants who had the GERD symptom -difficulty of swallowing at baseline were included.||Percentage of participants|||Number
672721|NCT01669811|Secondary|Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Abdominal Pain at Week 4|Cumulative percentage of participants who had sustained resolution (defined as at least 7-day consecutive symptom free) of gastroesophageal reflux disease (GERD) symptom -abdominal pain at Week 4 (on Day 29) based on the Kaplan-Meier method.|4 Weeks|Included all of the randomised participants who were definitely diagnosed to have refractory RE before the randomisation and who took at least one dose of investigational product. However, out of these participants, only participants who had the GERD symptom -abdominal pain at baseline were included.||Percentage of participants|||Number
672722|NCT01669811|Secondary|Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Acid Regurgitation at Week 4|Cumulative percentage of participants who had sustained resolution (defined as at least 7-day consecutive symptom free) of gastroesophageal reflux disease (GERD) symptom -acid regurgitation at Week 4 (on Day 29) based on the Kaplan-Meier method.|4 Weeks|Included all of the randomised participants who were definitely diagnosed to have refractory RE before the randomisation and who took at least one dose of investigational product. However, out of these participants, only participants who had the GERD symptom -acid regurgitation at baseline were included.||Percentage of participants|||Number
672723|NCT01669811|Secondary|Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Heartburn at Week 4|Cumulative percentage of participants who had sustained resolution (defined as at least 7-day consecutive symptom free) of gastroesophageal reflux disease (GERD) symptom -heartburn at Week 4 (on Day 29) based on the Kaplan-Meier method.|4 Weeks|Included all of the randomised participants who were definitely diagnosed to have refractory RE before the randomisation and who took at least one dose of investigational product. However, out of these participants, only participants who had the GERD symptom -heartburn at baseline were included.||Percentage of participants|||Number
672724|NCT01669811|Secondary|"Percentage of Participants With Healing of RE Who Were Graded O at Week 4 Out of Participants Who Were Graded A to D at Baseline According to Los Angeles Classification"|"Percentage of participants with healing of reflux esophagitis (RE) who were graded O (No RE) at Week 4 out of participants who were graded A (least severe) to D (most severe) at baseline according to Los Angeles classification"|4 Weeks|Included all of the randomised participants who were definitely diagnosed to have refractory RE before the randomisation and who had at least one dose of investigational product||Percentage of participants||95% Confidence Interval|Number
672725|NCT01669811|Primary|"Percentage of Participants With Healing of RE Who Were Graded O at Week 8 Out of Participants Who Were Graded A to D at Baseline According to Los Angeles Classification"|"Percentage of participants with healing of reflux esophagitis (RE) who were graded O (No RE) at Week 8 out of participants who were graded A (least severe) to D (most severe) at baseline according to Los Angeles classification"|8 Weeks|Included all of the randomised participants who were definitely diagnosed to have refractory RE before the randomisation and who had at least one dose of investigational product||Percentage of participants||95% Confidence Interval|Number
672726|NCT01669785|Secondary|Long-term Sensitivity Relief (Self-Assessment)|"All subjects completed a questionnaire titled How sensitive are your teeth? to assess their whole-mouth tooth sensitivity 28 days following prophylaxis treatment.
The questionnaire contained a 4-item verbal descriptor scale as follows:
Score 0= no discomfort or awareness of sensitivity;1=mild discomfort/pain from sensitive teeth; 2=moderate discomfort/pain from sensitive teeth; 3=severe pain from sensitive teeth.
The higher the score, the higher the hypersensitivity.
Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth."|28 days post-prophylaxis treatment.|||units on a scale||Standard Deviation|Mean
672727|NCT01669785|Secondary|Post-prophylaxis Sensitivity Relief (Self-Assessment)|"All subjects completed a questionnaire titled How sensitive are your teeth? to assess their whole-mouth tooth sensitivity immediately following the timed, 1-minute prophylaxis paste application.
The questionnaire contained a 4-item verbal descriptor scale as follows:
Score 0= no discomfort or awareness of sensitivity; 1=mild discomfort/pain from sensitive teeth;2=moderate discomfort/pain from sensitive teeth; 3=severe pain from sensitive teeth.
The higher the score, the higher the hypersensitivity.
Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth."|Immediately following post-prophylaxis treatment.|||units on a scale||Standard Deviation|Mean
672738|NCT01669629|Secondary|Overall Corneal Staining|"Proportion of subjects that have corneal staining on the 0-4 the NEI/Industry Workshop guidelines scale, measured by eye.
Grade 1 or higher is reported as a percentage of total eyes."|6-10 Days|Subjects are those who were enrolled, randomized, and completed the study per protocol. Percentage of eyes.||percentage of eyes|Participants||Number
672728|NCT01669785|Secondary|Post- Scaling Sensitivity Relief (Self-Assessment)|"All subjects completed a questionnaire titled How sensitive are your teeth? to assess their whole-mouth tooth sensitivity immediately following the scaling procedure.
The questionnaire contained a 4-item verbal descriptor scale as follows:
Score 0= no discomfort or awareness of sensitivity; 1=mild discomfort/pain from sensitive teeth; 2=moderate discomfort/pain from sensitive teeth; 3=severe pain from sensitive teeth.
The higher the score, the higher the hypersensitivity.
Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth."|Post-scaling procedure,immediate|||units on a scale||Standard Deviation|Mean
672729|NCT01669785|Primary|Long-term Sensitivity Relief (Schiff Air Blast Sensitivity)|"Assessment of sensitivity score Schiff air blast measurements long term after treatment.
Air blast hypersensitivity is measured using the Schiff Cold Air Sensitivity scale (0-3). The scale is scored as follows:
0=Subject does not respond to stimulus; 1= Subject responds to stimulus but does not request discontinuation of stimulus; 2=Subject responds to stimulus and requests discontinuation or moves from air stimulus; 3=Subject responds to stimulus, considers it painful and requests discontinuation.
Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth."|28 days (+/- 2 days) post treatment.|||units on a scale||Standard Deviation|Mean
672730|NCT01669785|Primary|Immediate Sensitivity Relief (Schiff Air Blast Sensitivity)|"Assessment of sensitivity score via air blast measurements immediately after treatment.
Air blast hypersensitivity is measured using the Schiff Cold Air Sensitivity scale (0-3). The scale is scored as follows:
0=Subject does not respond to stimulus; 1= Subject responds to stimulus but does not request discontinuation of stimulus; 2=Subject responds to stimulus and requests discontinuation or moves from air stimulus; 3=Subject responds to stimulus, considers it painful and requests discontinuation.
Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth."|Immediately after treatment .|||units on a scale||Standard Deviation|Mean
672731|NCT01669785|Primary|Baseline Pre-Prophy Assessment (Air Blast Sensitivity)|"Pre-prophy procedure baseline assessment using Schiff Cold Air Sensitivity scale (0-3).
Air blast hypersensitivity is measured using the Schiff Cold Air Sensitivty scale (0-3). The scale is scored as follows:
0=Subject does not respond to stimulus; 1= Subject responds to stimulus but does not request discontinuation of stimulus; 2=Subject responds to stimulus and requests discontinuation or moves from air stimulus; 3=Subject responds to stimulus, considers it painful and requests discontinuation.
The higher the score, the higher the hypersensitivity.
Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth."|Pre-treatment measurement|||units on a scale||Standard Deviation|Mean
672732|NCT01669785|Secondary|Sensitivity Relief (Self-Assessment)|"All subjects completed a questionnaire titled How sensitive are your teeth? to assess their whole-mouth tooth sensitivity prior to the baseline assessments.
The questionnaire contained a 4-item verbal descriptor scale as follows:
Score 0= no discomfort or awareness of sensitivity; 1=mild discomfort/pain from sensitive teeth; 2=moderate discomfort/pain from sensitive teeth; 3=severe pain from sensitive teeth.
The higher the score, the higher the hypersensitivity.
Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth."|Pre-Treatment|||units on a scale||Standard Deviation|Mean
672733|NCT01669785|Primary|Long-term Sensitivity Relief (Tactile Sensitivity)|"Assessment of sensitivity score via tactile measurements long term after treatment.
Tactile hypersensitivity is measured with an electronic force sensing probel (Yeaple probe). Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. 10 to 50 grams of force are applied to the hypersensitive tooth until pain is elicited. The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitivity.
Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth."|28 days (+/- 2 days) post treatment.|||grams||Standard Deviation|Mean
672734|NCT01669785|Primary|Immediate Sensitivity Relief (Tactile Sensitivity)|"Assessment of sensitivity score via tactile and air blast measurements immediately after treatment. Tactile hypersensitivity is measured with an electronic force sensing probel (Yeaple probe). Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. 10, 20, 30, 40 up to 50 grams of force are applied to the hypersensitive tooth until pain is elicited. The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitivity.
Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth."|Immediately after treatment .|||grams||Standard Deviation|Mean
672735|NCT01669785|Primary|Baseline Pre-Prophy Assessment (Tactile Sensitivity)|"Pre-prophy procedure baseline assessment is measured with an electronic force sensing probe (Yeaple probe). Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. 10,20,30,40, up to 50 grams of force are applied to the hypersensitive tooth until pain is elicited. The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitiv
Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth."|Pre-treatment measurement|||grams||Standard Deviation|Mean
672736|NCT01669720|Secondary|Adverse Events for Patients Receiving Adjuvant Aflibercept, up to 2-years of Duration, for Patients Who Previously Received Systemic Chemotherapy and Surgical Resection/Ablation.||Every 2 weeks for up to 2 years||||||
672737|NCT01669720|Primary|Number of Patients Who Progressed|Disease free survival in patients with advanced colorectal cancer who have undergone resection/ablation of all metastatic sites.|Every 3 months until disease progression (for up to 2 years).|||participants|||Number
675660|NCT01636778|Secondary|Mean Heart Rate at the Indicated Time Points During Follow-up Period After Part 2|The heart rate was measured in participants at the indicated time points.|FU Baseline, FU Week 4, FU Week 12 and FU Week 24 after Part 2|SP2 Population.||bpm||Standard Deviation|Mean
672742|NCT01669629|Primary|Subject Reported Ease of Removal|Measured on a 5 point-scale of excellence (excellent, very good, good, fair and poor) per a participant. Outcome is reported as aggregate number of subjects who reported Excellent/Very Good at their 1-week visit.|6-10 Days|Subjects analyzed were those who enrolled, randomized, and completed the study per protocol.||percentage of participants|||Number
672743|NCT01669603|Primary|Interleukin-8 (IL-8)|Nasal lavage will be performed to collect and measure IL-8.|72 hours|analysis cohort was those volunteers who were susceptible to RV-A39 by neutralizing antibody titer, had no virus detected in the nasal lavage on day 0, and who were infected and completed the study||pg/ml||Standard Deviation|Geometric Mean
672744|NCT01669577|Primary|Death|30 days after trauma mortality evaluation|Within the first 30 days|severe polytrauma patients (ISS>15)||participants|||Number
672745|NCT01669174|Secondary|AUC0-56 and AUClast|AUC0-56, the area under the serum concentration-time curve from the time zero to the end of the dosing interval, day 56. AUC0-56 was analyzed for dose 1 and 2. AUClast is from time zero to the last quantifiable concentration. AUClast was analyzed for dose 2 only.|0 hour, 2 hour, Day 8, 15, 29, 57, 71, 85, 99, 113, 127, 168 post dose|Pharmacokinetics (PK) analysis set: Patients with evaluable PK data.||day*ug/mL||Standard Deviation|Mean
672746|NCT01669174|Secondary|Time to Reach the Maximum Concentration After Drug Administration (Tmax)|The time to reach the maximum concentration after drug administration|24 weeks|Pharmacokinetics (PK) analysis set: Patients with evaluable PK data.||hr||Full Range|Median
672747|NCT01669174|Secondary|Maximum Observed Serum Concentration (Cmax)|The observed maximum plasma concentration following drug administration|0 hour, 2 hour, Day 8, 15, 29, 57, 71, 85, 99, 113, 127, 168 post dose|Pharmacokinetics (PK) analysis set: Patients with evaluable PK data.||ug/mL||Standard Deviation|Mean
672748|NCT01669174|Secondary|Change in 6 Minute Walk Distance Compared to Placebo|Practical simple test that requires a 100-ft hallway but no exercise quipment or advanced training for technicians. Walking is an activity performed daily by all but the most severely impaired patients. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD)|Baseline, Weeks 4, 8, 16, 24|Pharmacodynamics (PD) analysis set: Patients with evaluable PD parameter data. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame||meter||Standard Deviation|Mean
672749|NCT01669174|Primary|Percentage Change From Baseline of Thigh Muscle Volume (TMV) by MRI Scan at Week 4, 8, 16, and 24|Thigh Muscle Volume (TMV) change was evaluated by a responder analysis. Patients whose loss of muscle TMV by MRI was no more than or equal to 2% at Week 4,8,16 and 24 was considered responders.|Baseline, Weeks 4, 8, 16, 24|Pharmacodynamics (PD) analysis set: Patients with evaluable PD parameter data. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame.||Percentage Change of TMV||Standard Deviation|Mean
672750|NCT01669148|Primary|Detection of Breast Cancer (Sensitivity)|"Sensitivity is the number of true positives (TP) divided by the sum of TP and false negatives (FN):
Sensitivity = TP / (TP+FN)"|up to two years follow up for development of breast cancer|PI left institution in 2012; Data remaining did not include outcome measure and adverse event data. Institution contacted PI on numerous occasions. PI also does not have data.|||||
672751|NCT01669122|Secondary|Plasma Half Life (t1/2)|Half-life of elimination of nicotine was determined. t1/2 was based on the baseline adjusted nicotine plasma concentration data.|Blood samples were collected pre-dose and at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing|PP population: all randomized participants profiles, without a protocol deviation that would have lead to the data exclusion.||hours||Standard Deviation|Mean
672752|NCT01669122|Secondary|Rate of Elimination (Kel)|Elimination rate constant for nicotine was calculated. Kel was based on the baseline adjusted nicotine plasma concentration data.|Blood samples were collected pre-dose at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing|PP population: all randomized participants profiles, without a protocol deviation that would have lead to the data exclusion.||1/ hour||Standard Deviation|Mean
672753|NCT01669122|Secondary|Time to Maximum Plasma Concentration (Tmax)|Tmax was determined from plasma concentration time profiles. Tmax was based on the baseline adjusted nicotine plasma concentration data.|Blood samples were collected pre-dose and at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing|PP population: all randomized participants profiles, without a protocol deviation that would have lead to the data exclusion.||hours||Full Range|Median
672754|NCT01669122|Secondary|AUC(0-inf)|Area under the plasma nicotine concentration-time curve from zero extrapolated to infinity was determined. AUC(0-inf) was based on the baseline adjusted nicotine plasma concentration data.|Blood samples were collected pre-dose and at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing|PP population: all randomized participants profiles, without a protocol deviation that would have lead to the data exclusion.||ng*hr/mL||Standard Deviation|Mean
672755|NCT01669122|Primary|Maximum Plasma Concentration (Cmax)|Maximum plasma nicotine concentration was determined from plasma-concentration time profiles. Cmax was based on the baseline adjusted nicotine plasma concentration data.|Blood samples were collected pre-dose and at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing|PP population: all randomized participants profiles, without a protocol deviation that would have lead to the data exclusion.||ng/mL||Standard Deviation|Mean
672756|NCT01669122|Primary|Area Under the Curve From Time 0 to t, AUC (0-t)|Area under the plasma concentration time curve from zero and extrapolated to the time of last quantifiable sample was determined from plasma concentration time profile of nicotine. AUC(0 -t) was based on the baseline adjusted nicotine plasma concentration data.|Blood samples were collected pre-dose and at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing|Per protocol (PP) population: all randomized participants profiles, without a protocol deviation that would have lead to the data exclusion.||nanograms (ng)*hours (h)/milliliter (mL)||Standard Deviation|Mean
672757|NCT01668836|Secondary|Influence of the Sirtuin 1 System on Max Elasticity of Clot on Thromboelastography.|"For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:
-max elasticity of clot on thromboelastography"|30 days post-treatment|||"Pascal"||Standard Deviation|Mean
673681|NCT01660672|Secondary|Range of Plasma Concentration of LVT Across All Individuals|Range of plasma LVT concentrations will be determined through HPLC method at eight timepoints post administration to evaluate LVT absorption and elimination in pediatric CM.|72 hours|||mcg/ml||Full Range|Mean
672759|NCT01668836|Secondary|Influence of the Sirtuin 1 System on Thromboelastography Clot Formation.|"For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:
-dynamics of clot formation: clot onset time and clot complet"|30 days post-treatment|||"sec"||Standard Deviation|Mean
672760|NCT01668836|Secondary|Influence of the Sirtuin 1 System on Receptor for Advanced Glycation End Products (RAGE) Gene Expression|"For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:
RAGE gene expression
Arbitrary unit was relative to the control gene expression (control gene = 1)"|30 days post-treatment|||arbitrary unit relative to control gene||Standard Deviation|Mean
672761|NCT01668836|Secondary|Influence of the Sirtuin 1 System on Estrone and Norepinephrine.|"For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:
- estrone, norepinephrine."|30 days post-treatment|||"pg/dL"||Standard Deviation|Mean
672762|NCT01668836|Secondary|Influence of the Sirtuin 1 System on Biomarkers|"For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:
- non-esterified fatty acids, insulin, luteinizing hormone, follicle stimulating hormone."|30 days post-treatment|||"microUI/mL"||Standard Deviation|Mean
672763|NCT01668836|Secondary|Influence of the Sirtuin 1 System on Platelet Aggregation.|"For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:
- platelet aggregation by ADP and norepinephrine."|30 days post-treatment|||percentage platelet aggregation||Standard Deviation|Mean
672764|NCT01668836|Secondary|Influence of the Sirtuin 1 System on Estradiol|"For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:
- estradiol"|30 days post-treatment|||"pg/mL"||Standard Deviation|Mean
672765|NCT01668836|Secondary|Influence of the Sirtuin 1 System on Apolipoproteins AI and B.|"For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:
- apolipoproteins AI and B"|30 days post-treatment|||"g/dL"||Standard Deviation|Mean
672766|NCT01668836|Primary|Sirtuin|Sirtuin plasma levels before and 30 days post-treatment|30 days post-treatment|||ng/mL||Standard Deviation|Mean
672767|NCT01668836|Other Pre-specified|Differences Between Men and Women.|We will also compare women vs men baseline and final data.|30 days||||||
672768|NCT01668836|Secondary|Influence of the Sirtuin 1 System on Lipid Profile, Glucose, and C-reactive Protein.|"For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:
- serum HDL, LDL, lipoprotein(a), C reactive protein, glucose."|30 days post-treatment|||"mg/dL"||Standard Deviation|Mean
672769|NCT01668836|Primary|Direct Evaluation of the Sirtuin 1 Gene Expression|"The Sirtuin 1 gene expression was measured by real time PCR in peripheric blood. Unit of measure was arbitrary unit. Arbitrary unit was relative to the control gene expression (control gene = 1)."|30 days post-treatment|||arbitrary unit relative to control gene||Standard Deviation|Mean
672770|NCT01668797|Other Pre-specified|Mean Change From Baseline in PANSS Marder Factor Scores: Anxiety/Depression Score - LOCF Analysis|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The anxiety/depression factor score is the sum of score from the 4 items on the anxiety/depression subscale (range: 4 - best possible outcome to 28 - worst possible outcome).|Baseline and Weeks 6, 12, 24, 36 and 52|The LOCF data set for Phase C included data recorded at a given Phase C visit or, if no observation is recorded at that visit, data carried forward from the previous Phase C visit. Baseline data was not be carried forward to impute missing values for the LOCF data set.||Units on a scale||Standard Error|Least Squares Mean
672771|NCT01668797|Other Pre-specified|Mean Change From Baseline in PANSS Marder Factor Scores: Anxiety/Depression Score - MMRM Analysis|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The anxiety/depression factor score is the sum of score from the 4 items on the anxiety/depression subscale (range: 4 - best possible outcome to 28 - worst possible outcome).|Baseline and Weeks 6, 12, 24, 36 and 52|Based on ITT principle, the full analysis set was composed of all participants randomized to the double-blind treatment who took at least one dose of study medication in Phase C and who had at least one post-randomization efficacy evaluation in Phase C.||Units on a scale||Standard Error|Least Squares Mean
672772|NCT01668797|Other Pre-specified|Mean Change From Baseline in PANSS Marder Factor Scores: Uncontrolled Hostility/Excitement Score - LOCF Analysis|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The uncontrolled hostility/excitement factor score is the sum of score from the 4 items on the uncontrolled hostility/excitement subscale (range: 4 - best possible outcome to 28 - worst possible outcome).|Baseline and Weeks 6, 12, 24, 36 and 52|The LOCF data set for Phase C included data recorded at a given Phase C visit or, if no observation is recorded at that visit, data carried forward from the previous Phase C visit. Baseline data was not be carried forward to impute missing values for the LOCF data set.||Units on a scale||Standard Error|Least Squares Mean
672773|NCT01668797|Other Pre-specified|Mean Change From Baseline in PANSS Marder Factor Scores: Uncontrolled Hostility/Excitement Score - MMRM Analysis|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The uncontrolled hostility/excitement factor score is the sum of score from the 4 items on the uncontrolled hostility/excitement subscale (range: 4 - best possible outcome to 28 - worst possible outcome).|Baseline and Weeks 6, 12, 24, 36 and 52|Based on ITT principle, the full analysis set was composed of all participants randomized to the double-blind treatment who took at least one dose of study medication in Phase C and who had at least one post-randomization efficacy evaluation in Phase C.||Units on a scale||Standard Error|Least Squares Mean
672774|NCT01668797|Other Pre-specified|Mean Change From Baseline in PANSS Marder Factor Scores: Disorganized Thought Score - LOCF Analysis|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The disorganized thoughts factor score is the sum of score from the 7 items on the disorganized thoughts subscale (range: 7 - best possible outcome to 49 - worst possible outcome).|Baseline and Weeks 6, 12, 24, 36 and 52|The LOCF data set for Phase C included data recorded at a given Phase C visit or, if no observation is recorded at that visit, data carried forward from the previous Phase C visit. Baseline data was not be carried forward to impute missing values for the LOCF data set.||Units on a scale||Standard Error|Least Squares Mean
672775|NCT01668797|Other Pre-specified|Mean Change From Baseline in PANSS Marder Factor Scores: Disorganized Thought Score - MMRM Analysis|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The disorganized thoughts factor score is the sum of score from the 7 items on the disorganized thoughts subscale (range: 7 - best possible outcome to 49 - worst possible outcome).|Baseline and Weeks 6, 12, 24, 36 and 52|Based on ITT principle, the full analysis set was composed of all participants randomized to the double-blind treatment who took at least one dose of study medication in Phase C and who had at least one post-randomization efficacy evaluation in Phase C.||Units on a scale||Standard Error|Least Squares Mean
672776|NCT01668797|Other Pre-specified|Mean Change From Baseline in PANSS Marder Factor Scores: Negative Symptoms Score - LOCF Analysis|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The negative factor score is the sum of the 7 items of the negative subscale (range: 8 - best possible outcome to 56 - worst possible outcome).|Baseline and Weeks 6, 12, 24, 36 and 52|The LOCF data set for Phase C included data recorded at a given Phase C visit or, if no observation is recorded at that visit, data carried forward from the previous Phase C visit. Baseline data was not be carried forward to impute missing values for the LOCF data set.||Units on a scale||Standard Error|Least Squares Mean
672777|NCT01668797|Other Pre-specified|Mean Change From Baseline in PANSS Marder Factor Scores: Negative Symptoms Score - MMRM Analysis|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The negative factor score is the sum of the 7 items of the negative subscale (range: 8 - best possible outcome to 56 - worst possible outcome).|Baseline and Weeks 6, 12, 24, 36 and 52|Based on ITT principle, the full analysis set was composed of all participants randomized to the double-blind treatment who took at least one dose of study medication in Phase C and who had at least one post-randomization efficacy evaluation in Phase C.||Units on a scale||Standard Error|Least Squares Mean
672778|NCT01668797|Other Pre-specified|Mean Change From Baseline in PANSS Marder Factor Scores: Positive Symptoms Score - LOCF Analysis|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The positive factor score is the sum of the 8 components of the positive symptoms scale (range: 8 - best possible outcome to 56 - worst possible outcome).|Baseline and Weeks 6, 12, 24, 36 and 52|The LOCF data set for Phase C included data recorded at a given Phase C visit or, if no observation is recorded at that visit, data carried forward from the previous Phase C visit. Baseline data was not be carried forward to impute missing values for the LOCF data set.||Units on a scale||Standard Error|Least Squares Mean
672779|NCT01668797|Other Pre-specified|Mean Change From Baseline in PANSS Marder Factor Scores: Positive Symptoms Score - MMRM Analysis|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The positive factor score is the sum of the 8 components of the positive symptoms scale (range: 8 - best possible outcome to 56 - worst possible outcome).|Baseline and Weeks 6, 12, 24, 36 and 52|Based on ITT principle, the full analysis set was composed of all participants randomized to the double-blind treatment who took at least one dose of study medication in Phase C and who had at least one post-randomization efficacy evaluation in Phase C.||Units on a scale||Standard Error|Least Squares Mean
672925|NCT01667731|Secondary|Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set||percentage of participants|||Number
685306|NCT01505374|Secondary|Patient Satisfaction With Nerve Blocks|Rated on a 0-10 scale, with a higher score representing greater satisfaction.|Up to postoperative day 1|||units on a scale||Standard Deviation|Mean
672780|NCT01668797|Other Pre-specified|Mean Change From Baseline in PEC Score - LOCF Analysis|The PEC score consisted of five PANSS items: excitement (P4), hostility (P7), tension (G4), uncooperativeness (G8), and poor impulse control (G14). Each of the items were rated on a scale of 1 (absent) to 7 (extreme). The PEC scores ranged from 5 (not present) to 35 (extremely severe).|Baseline and Weeks 6, 12, 24, 36 and 52|The LOCF data set for Phase C included data recorded at a given Phase C visit or, if no observation is recorded at that visit, data carried forward from the previous Phase C visit. Baseline data was not be carried forward to impute missing values for the LOCF data set.||Units on a scale||Standard Error|Least Squares Mean
672781|NCT01668797|Other Pre-specified|Mean Change From Baseline in PANSS Excited Component (PEC) Score - MMRM Analysis|The PEC score consisted of five PANSS items: excitement (P4), hostility (P7), tension (G4), uncooperativeness (G8), and poor impulse control (G14). Each of the items were rated on a scale of 1 (absent) to 7 (extreme). The PEC scores ranged from 5 (not present) to 35 (extremely severe).|Baseline and Weeks 6, 12, 24, 36 and 52|The last-observation-carried-forward (LOCF) data set included data recorded at a given Phase C visit or, if no observation is recorded at that visit, data carried forward from the previous Phase C visit. Baseline data (eg.the last visit prior to the first dosing of Phase C) were not be carried forward to impute missing values for the LOCF data set.||Units on a scale||Standard Error|Least Squares Mean
672782|NCT01668797|Other Pre-specified|Percentage of Participants Who Discontinued Due to All Causes|Analysis of the percentage of participants who discontinued due to all causes was based on all participants who have been randomized and taken one dose of IMP in the Double-blind Maintenance phase. The trial was completed by sponsor when efficacy was demonstrated at the first pre-specified interim analysis (45 impending relapse events) performed by an independent (unblinded) statistician.|Baseline to Week 52|Based on ITT principle, the full analysis set was composed of all participants randomized to the double-blind treatment who took at least one dose of study medication in Phase C and who had at least one post-randomization efficacy evaluation in Phase C.||Percentage of particpants|||Number
672783|NCT01668797|Other Pre-specified|Mean Change From Baseline in GAF Scale Score - LOCF Analysis|The GAF is a clinician-rated scale that assesses the participant's psychological, social, and occupational functioning on a hypothetical continuum of mental health-illness using a scale that ranges from 1 to 100 score, where lower values indicate worst outcome. From among 10 descriptive anchors, investigators will choose the anchor which is the most representative of the participant's level of functioning at the time of the assessment and will assign a single score within the point range given for the selected anchor.|Baseline and Weeks 12, 24, 36 and 52|The LOCF data set for Phase C included data recorded at a given Phase C visit or, if no observation is recorded at that visit, data carried forward from the previous Phase C visit. Baseline data was not be carried forward to impute missing values for the LOCF data set.||Units on a scale||Standard Error|Least Squares Mean
672784|NCT01668797|Other Pre-specified|Mean Change From Baseline in Global Assessment of Functioning (GAF) Scale Score - MMRM Analysis|The GAF is a clinician-rated scale that assesses the participant's psychological, social, and occupational functioning on a hypothetical continuum of mental health-illness using a scale that ranges from 1 to 100 score, where lower values indicate worst outcome. From among 10 descriptive anchors, investigators will choose the anchor which is the most representative of the participant's level of functioning at the time of the assessment and will assign a single score within the point range given for the selected anchor.|Baseline and Weeks 12, 24, 36 and 52|Based on ITT principle, the full analysis set was composed of all participants randomized to the double-blind treatment who took at least one dose of study medication in Phase C and who had at least one post-randomization efficacy evaluation in Phase C.||Units on a scale||Standard Error|Least Squares Mean
672785|NCT01668797|Other Pre-specified|Mean Change From Baseline in PSP Scale Score - LOCF Analysis|The PSP is a validated clinician-rated scale that measures personal and social functioning in four domains: socially useful activities (e.g., work and study), personal and social relationships, self-care, and disturbing and aggressive behaviors. Impairment in each of these domains is rated as absent, mild, manifest, marked, severe, or very severe. These ratings are then converted to a total score based on a 100-point scale using algorithms to identify the appropriate 10-point interval, and the rater’s judgment to determine the total score within the 10-point interval. Participants with a PSP total score of 71 to 100 are considered to have mild functional difficulty. Scores of 31 to 70 represent manifest disabilities of various degrees and ratings of 1 to 30 indicate minimal functioning that requires intense support and/or supervision.The PSP score ranges from 0 to 100, with higher scores indicating higher levels of social functioning.|Baseline and Weeks 24 and 52|The LOCF data set for Phase C included data recorded at a given Phase C visit or, if no observation is recorded at that visit, data carried forward from the previous Phase C visit. Baseline data was not be carried forward to impute missing values for the LOCF data set.||Units on a scale||Standard Error|Least Squares Mean
672786|NCT01668797|Other Pre-specified|Mean Change From Baseline in Personal and Social Performance (PSP) Scale Score - MMRM Analysis|The PSP is a validated clinician-rated scale that measures personal and social functioning in four domains: socially useful activities (e.g., work and study), personal and social relationships, self-care, and disturbing and aggressive behaviors. Impairment in each of these domains is rated as absent, mild, manifest, marked, severe, or very severe. These ratings are then converted to a total score based on a 100-point scale using algorithms to identify the appropriate 10-point interval, and the rater’s judgment to determine the total score within the 10-point interval. Participants with a PSP total score of 71 to 100 are considered to have mild functional difficulty. Scores of 31 to 70 represent manifest disabilities of various degrees and ratings of 1 to 30 indicate minimal functioning that requires intense support and/or supervision.The PSP score ranges from 0 to 100, with higher scores indicating higher levels of social functioning.|Baseline and Weeks 24 and 52|Based on ITT principle, the full analysis set was composed of all participants randomized to the double-blind treatment who took at least one dose of study medication in Phase C and who had at least one post-randomization efficacy evaluation in Phase C.||Units on a scale||Standard Error|Least Squares Mean
672826|NCT01668654|Primary|Number of Partcipants With Hematology, Chemistry and Urinalysis Parameters Outside the Normal Ranges and Pre-determined Clinically Important Ranges|Clinical laboratory assessment included hematology, chemistry and urinalysis parameters. Clinical laboratory parameters were measured at Visit 1, 4, 5, 6, 7, EW and FU Visit. Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population|||||
672787|NCT01668797|Other Pre-specified|Clinical Global Impression - Improvement Score (CGI-I) at Endpoint - LOCF Analysis|The rater or investigator would rate the participant's total improvement whether or not it is due entirely to study treatment. During Phase B, responses were compared to the participant's condition at Baseline of Phase B (for participants who entered Phase B directly after screening) or to the End of Phase A visit (for participants who participated in Phase A). During Phase C, responses were compared to the participant's condition at the End of Phase B visit. Response choices include: 0 = Not assessed, 1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6 = Much worse, and 7 = Very much worse.|Weeks 6, 12, 24, 36 and 52|The LOCF data set for Phase C included data recorded at a given Phase C visit or, if no observation is recorded at that visit, data carried forward from the previous Phase C visit. Baseline data was not be carried forward to impute missing values for the LOCF data set.||Units on a scale||Standard Deviation|Mean
672788|NCT01668797|Other Pre-specified|Change From Baseline in CGI-S Score at Endpoint - LOCF Analysis|The severity of illness for each participant was rated using the CGI-S scale. To assess CGI-S, the study physician answered the following question: “Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?” Response choices included: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.|Baseline and Weeks 6, 12, 24, 36 and 52|The LOCF data set for Phase C included data recorded at a given Phase C visit or, if no observation is recorded at that visit, data carried forward from the previous Phase C visit. Baseline data was not be carried forward to impute missing values for the LOCF data set.||Units on a scale||Standard Error|Least Squares Mean
672789|NCT01668797|Other Pre-specified|Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Endpoint - MMRM Analysis|The severity of illness for each participant was rated using the CGI-S scale. To assess CGI-S, the study physician answered the following question: “Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?” Response choices included: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.|Baseline, Weeks 6, 12, 24, 36 and 52|Based on ITT principle, the full analysis set was composed of all participants randomized to the double-blind treatment who took at least one dose of study medication in Phase C and who had at least one post-randomization efficacy evaluation in Phase C.||Units on a scale||Standard Error|Least Squares Mean
672790|NCT01668797|Other Pre-specified|Mean Change From Baseline in PANSS Negative Subscale Score - LOCF Analysis|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS negative subscale score ranged from 7 (best possible outcome) to 49 (worst possible outcome).|Baseline and Weeks 6, 12, 24, 36 and 52|The LOCF data set for Phase C included data recorded at a given Phase C visit or, if no observation is recorded at that visit, data carried forward from the previous Phase C visit. Baseline data was not be carried forward to impute missing values for the LOCF data set.||Units on a scale||Standard Error|Least Squares Mean
672791|NCT01668797|Other Pre-specified|Mean Change From Baseline in PANSS Negative Subscale Score - MMRM Analysis|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS negative subscale score ranged from 7 (best possible outcome) to 49 (worst possible outcome).|Baseline and Weeks 6, 12, 24, 36 and 52|Based on ITT principle, the full analysis set was composed of all participants randomized to the double-blind treatment who took at least one dose of study medication in Phase C and who had at least one post-randomization efficacy evaluation in Phase C.||Units on a scale||Standard Error|Least Squares Mean
672792|NCT01668797|Other Pre-specified|Mean Change From Baseline in PANSS Positive Subscale Score - LOCF Analysis|PANSS consisted of three subscales: a total of 30 symptom constructs. For each construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS positive subscale score was the sum of the rating scores for the 7 positive scale items from the PANSS panel. The 7 positive symptom constructs are delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS positive subscale score ranged from 7 (best possible outcome) to 49 (worst possible outcome).|Baseline and Weeks 6, 12, 24, 36 and 52|The LOCF data set for Phase C included data recorded at a given Phase C visit or, if no observation is recorded at that visit, data carried forward from the previous Phase C visit. Baseline data was not be carried forward to impute missing values for the LOCF data set.||Units on a scale||Standard Error|Least Squares Mean
672793|NCT01668797|Other Pre-specified|Mean Change From Baseline in PANSS Positive Subscale Score - MMRM Analysis|PANSS consisted of three subscales: a total of 30 symptom constructs. For each construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS positive subscale score was the sum of the rating scores for the 7 positive scale items from the PANSS panel. The 7 positive symptom constructs are delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS positive subscale score ranged from 7 (best possible outcome) to 49 (worst possible outcome).|Baseline and Weeks 6, 12, 24, 36 and 52|Based on ITT principle, the full analysis set was composed of all participants randomized to the double-blind treatment who took at least one dose of study medication in Phase C and who had at least one post-randomization efficacy evaluation in Phase C.||Units on a scale||Standard Error|Least Squares Mean
672926|NCT01667731|Primary|Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)|The percentage of participants discontinuing any study drug due to an adverse event was summarized.|Up to 24 weeks|Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug||percentage of participants|||Number
672794|NCT01668797|Other Pre-specified|Mean Change From Baseline in PANSS Total Score - Last-observation-carried-forward (LOCF) Analysis|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline and Weeks 6, 12, 24, 36 and 52|The LOCF data set for Phase C included data recorded at a given Phase C visit or, if no observation is recorded at that visit, data carried forward from the previous Phase C visit. Baseline data was not be carried forward to impute missing values for the LOCF data set.||Units on a scale||Standard Error|Least Squares Mean
672795|NCT01668797|Other Pre-specified|Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score - MMRM Analysis|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline and Weeks 6, 12, 24, 36 and 52|Based on ITT principle, the full analysis set was composed of all participants randomized to the double-blind treatment who took at least one dose of study medication in Phase C and who had at least one post-randomization efficacy evaluation in Phase C.||Units on a scale||Standard Error|Least Squares Mean
672796|NCT01668797|Other Pre-specified|Percentage of Participants Meeting Stability Criteria in Double Blind Maintenance Phase|Participants were assessed for stability using the following criteria:1) Outpatient status AND 2) Positive and Negative Syndrome Scale (PANSS) Total Score ≤ 70 AND 3) A score of ≤ 4 (moderate) on each of the following PANSS items (possible scores of 1 to 7 for each item): conceptual disorganization, suspiciousness hallucinatory behavior, unusual thought content, AND 4) Clinical Global Impression - Severity of Illness scale(CGI-S) score ≤ 4 (moderately ill) AND 5) No current suicidal behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS), defined as the following: An answer of “no” to each question on the Suicidal Behavior section of the C-SSRS AND an answer of “no” to Questions 4 and 5 on the Suicidal Ideation section of the C-SSRS, if completed, AND 6) No evidence of aggressive or violent behavior resulting in clinically significant self-injury, injury to another person, property damage.|Weeks 6, 12, 24, 36 and 52|Based on ITT principle, the full analysis set of this trial was composed of all participants randomized to the double-blind treatment who took at least one dose of study medication in Phase C and who had at least one post-randomization efficacy evaluation in Phase C.||percentage of participants|||Number
672797|NCT01668797|Secondary|Percentage of Participants Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria in the Double-blind Maintenance Phase|"Impending relapse was defined as meeting any of the following 5 criteria: 1) CGI-I score of ≥ 5 (minimally worse) and increase in individual PANSS items to a score > 4 with an absolute increase of ≥ 2 on that specific item or an increase on any of the following individual PANSS items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual though content) to a score of >4 and an absolute increase of ≥ 4 on the combined 4 PANSS items. OR 2) CGI-I score of 6 or 7 (much or very much worse) OR 3) Hospitalization due to worsening of illness OR 4) Current suicidal behavior as assessed by the C-SSRS (ie, an answer of yes to any of the questions on the suicidal behavior section of the C-SSRS 5) Violent or aggressive behavior resulting in clinically significant self-injury to another person, or property damage."|Baseline and Week 52/Early Termination|Based on ITT principle, the full analysis set of this trial was composed of all participants randomized to the double-blind treatment who took at least one dose of study medication in Phase C and who had at least one post-randomization efficacy evaluation in Phase C.||percentage of participants|||Number
672798|NCT01668797|Primary|Time From Randomization to Exacerbation of Psychotic Symptoms/Impending Relapse in Phase C.|The primary efficacy variable was time to impending relapse from randomization, as assessed by Clinical Global Impression of Improvement (CGI-I) score ≥5, Positive and Negative Syndrome Scale (PANSS) scores for hostility or uncooperativeness ≥5, or ≥20% increase in PANSS Total Score. Impending relapse was defined as meeting any of the following 5 criteria: 1) CGI-I score of ≥ 5 (minimally worse) and increase in individual PANSS items to a score >4 with an absolute increase of ≥ 2 on that specific item or absolute increase of ≥ 4 on the combined 4 PANSS items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content).OR 2) CGI-I score of 6 or 7 (much or very much worse) OR 3) Hospitalization due to worsening of illness OR 4) Any suicidal behavior or answers of “yes” to Questions 4 or 5 on the suicidal ideation section of the C-SSRS OR 5) Violent or aggressive behavior resulting in clinically significant injury.The measure type, number is Hazard Ratio.|From randomization to time of exacerbation of psychotic symptoms/impending relapse - up to 52 weeks|Based on the Intent-to-Treat (ITT) principle, the full analysis set of this trial was composed of all participants randomized to the double-blind treatment who took at least one dose of study medication in Phase C and who had at least one post-randomization efficacy evaluation in Phase C.||Days||95% Confidence Interval|Number
672809|NCT01668667|Secondary|The Dose-response Relationship for Investigator-rated CGI-I Scale at End of Treatment||12 Weeks|mITT (modified intent to treat) Population: The mITT population will include all randomly assigned subjects who received at least 1 dose (or any portion of a dose) of study medication as defined above for the Safety population, have a baseline IRLS Rating Scale total score, and have at least 1 on-treatment IRLS Rating Scale total score.||percentage of participants|||Number
672810|NCT01668667|Secondary|The Dose-response Relationship of Change From Baseline in IRLS Rating Scale Total Score at End of Treatment|"International Restless Legs Syndrome Rating Scale: Very severe=31-40, Severe=21-30, Moderate=11-20, Mild=1-10, None=0.
This model only includes treatment in the model. Least squares mean is used for analysis."|Baseline, 12 Weeks|mITT (modified intent to treat) Population: The mITT population will include all randomly assigned subjects who received at least 1 dose (or any portion of a dose) of study medication as defined above for the Safety population, have a baseline IRLS Rating Scale total score, and have at least 1 on-treatment IRLS Rating Scale total score.||units on a scale||Standard Error|Least Squares Mean
672811|NCT01668667|Primary|The Proportion of Subjects at the End of Treatment Who Are Responders With Either “Much Improved” or “Very Much Improved” on the Investigator-rated Clinical Global Impression of Improvement (CGI-I)|Clinical Global Impression - Improvement Scale (CGI-I): 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), on the scale. Higher score = more affected. Number of subjects responding to treatment at Week 12 with respect to dose level. CGI-I Responders = subjects who reported CGI-I scores of very much improved or much improved.|12 weeks|mITT (modified intent to treat) population: The mITT population will include all randomly assigned subjects who received at least 1 dose (or any portion of a dose) of study medication as defined above for the Safety population, have a baseline IRLS Rating Scale total score, and have at least 1 on-treatment IRLS Rating Scale total score.||percentage of participants|||Number
672812|NCT01668667|Primary|The Change From Baseline to the End of Treatment in the International Restless Legs Syndrome (IRLS) Rating Scale Score|"International Restless Legs Syndrome Rating Scale: Very severe=31-40, Severe=21-30, Moderate=11-20, Mild=1-10, None=0.
Change from Baseline = LOCF value at current visit – value at Baseline (the last nonmissing assessment before the first dose of study medication). A negative treatment difference indicates a benefit relative to placebo.
The change from baseline data is analyzed using an ANCOVA model with treatment and pooled site as the main effects and the baseline IRLS Rating Scale total score as a covariate."|Baseline, 12 weeks|mITT (modified intent to treat) Population: The mITT population will include all randomly assigned subjects who received at least 1 dose (or any portion of a dose) of study medication as defined above for the Safety population, have a baseline IRLS Rating Scale total score, and have at least 1 on-treatment IRLS Rating Scale total score.||units on a scale||Standard Error|Mean
672813|NCT01668654|Secondary|Apparent Clearance (CL/F) Following Oral Administration of Retigabine/Ezogabine at Indicated Time Points|Blood samples for population pharmacokinetic analysis of retigabine/ezogabine were taken at clinic visits where routine clinical laboratory samples were also taken. CL/F, where CL is the calculated as dose/AUC and F is the oral bioavailability of the drug. Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled|Eligbility Assessment (Visit 1), up to 178 days|All Subjects Population|||||
672814|NCT01668654|Secondary|Area Under the Plasma Concentration-time Curve (AUC) Following Oral Administration of Retigabine/Ezogabine at the Indicated Time Points|AUC is defined as the area under the plasma drug concentration-time curve, reflects the actual body exposure to drug after administration of a dose of the drug and is expressed in milligram*hour per Liter (mg*h/L). Blood samples for population PK analysis of retigabine/ezogabine were taken at clinic visits where routine clinical laboratory samples were also taken. Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Eligibility Assessment (Visit 1) up to 178 days|All Subjects Population|||||
672815|NCT01668654|Secondary|Change From Baseline in Child Health Status as Measured by the Child Health Questionnaire (CHQ) in Participants <18 Years Old at the Indicated Time Points|The CHQ comprises scales specifically developed for children and adolescents aged five years and older. The CHQ assesses a child's physical, emotional, and social well-being from the perspective of a parent or guardian. The questionnaire was completed by a parent/caregiver and administration time was approximately 30 minutes. The parent/caregiver completed this questionnaire while the participant was within the age range (i.e. <18 years). Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibilty Assessment (Visit 1), EW Visit and FU Visit (up to 178 days)|All Subjects Population|||||
672816|NCT01668654|Secondary|Clinical Global Impression-Severity of Illness (CGI-S) Assessment at the Indicated Time Points|The Clinical Global Impression (CGI) scale provided an overall clinician-determined summary measure. It had 2 components: the CGI-Severity of Illness (CGI-S) scale and the CGI-Improvement (CGI-I) scale which rated the change from Baseline. The CGI-S was a 7-point scale that required the investigator to rate the severity of the participant’s epilepsy relative to the investigator’s past experience with other participants with the same diagnosis. The CGI-S scale scores range from 0 to 7 and are interpreted as 0=not assessed, 1=normal, 2=borderline, 3=mild, 4=moderate, 5=marked, 6=severe, 7=extremely severe. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1) up to 178 days|All Subjects Population|||||
672817|NCT01668654|Secondary|Clinical Global Impression- Improvement (CGI-I) Assessment at the Indicated Time Points|The Clinical Global Impression (CGI) scale provided an overall clinician-determined summary measure. It had 2 components: the CGI-Severity of Illness (CGI-S) scale and the CGI- Improvement (CGI-I) scale which rated the change from Baseline. The CGI-I scale scores range from 0 to 7 and are interpreted as 0=not assessed, 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1) up to 178 days|All Subjects Population|||||
672818|NCT01668654|Secondary|Number of Participants Who Were Responders During the Treatment Period|A ''responder'' is defined as >50% reduction from Baseline in the seizure frequency. Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Eligibility Assessment (Visit 1) up to 178 days|All Subjects Population|||||
672819|NCT01668654|Secondary|Percent Change From Baseline in the Seizure Frequency at the Indicated Time Points|The percentage reduction from Baseline in the seizure frequency was summarized using descriptive statistics. The frequencies and percentages were computed for a reduction in seizure frequency of >50% as well as for a 100% reduction (seizure-free). Increases of >50% in seizure frequency was also summarized. The percentage of seizure-free days wasere also analyzed. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Basline, Eligibility Assessment (Visit 1) up to 178 days|All Subjects Population|||||
672820|NCT01668654|Primary|Number of Days of Exposure to Retigabine/Ezogabine TID by Individual Participant|Total number of days each participant was exposed to Retigabine/Ezogabine are recorded here.|Treatment Phase plus Taper Phase (up to 97 days)|All Subjects Population||Days|||Number
672821|NCT01668654|Primary|Number of Participants With Sexual Maturation Based on the Tanner Stage I to Stage V of Puberty in Participants <=18 Years Old Throughout the Study|The number of participants who advanced a stage between the eligibility visit and the EW Visit was recorded. Tanner stage I is defined as no pubic hair at all (prepubertal Dominic state); stage II is defined as a small amount of long, downy hair with slight pigmentation at the base of the penis and scrotum (males) or on the labia majora (females); stage III is defined as when the hair becomes more coarse and curly, and begins to extend laterally; stage IV is defined as adult-like hair quality, extending across pubis but sparing medial thighs; and stage V is defined as when the: hair extends to medial surface of the thighs. The investigator assessed the participant's sexual development in participants <18 years old based on the Tanner Stages of Puberty.|Eligibility Assessment (Visit 1) and EW Visit|All Subjects Population||Participants|||Number
672822|NCT01668654|Primary|Changes From Baseline in Learning as Measured by the Wide Range Assessment of Memory and Learning , 2nd Edition (WRAML2) at the Indicated Time Points|The WRAML2 is a standardized test that measures an individual’s memory functioning. It evaluates both visual and verbal, immediate and delayed memory ability along with the acquisition of new learning. The WRAML2 core battery is composed of two verbal, two visual, and two attention concentration subtests, yielding a verbal memory index, a visual memory index and an attention-concentration index. Together, these tests yield the general memory index. The administration time is approximately 40 minutes. During the study, this test was administered if the participant was within the age range (i.e. >9 years). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). The parent study did not measure Baseline cognition, behavior, and learning so changes from Baseline were not available for participants in this study.|Baseline, Eligibility Assessment (Visit 1) up to 178 days|All Subjects Population|||||
672823|NCT01668654|Primary|Changes From Baseline in Behaviour as Measured by the Child Behavior Checklist (CBCL) at the Indicated Time Points|The CBCL is a widely used parent report questionnaire identifying behavioural and emotional problems in children. The checklist is comprised of a number of statements about the child's behavior, e.g. acts too young for his/her age. Responses were recorded on a likert scale: 0 = not true, 1 = somewhat or sometimes true, 2 = very true or often true. The preschool checklist contained 100 questions and the school-age checklist contained 120 questions. During the study, only the parent/caregiver completed this questionnaire while the participants were within the age range (i.e. <18 years). Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). The parent study did not measure baseline cognition, behavior, and learning so changes from baseline were not available for participants in this study.|Baseline, Eligibility Assessment (Visit 1) up to 178 days|All Subjects Population|||||
672824|NCT01668654|Primary|Changes From Baseline in Cognition as Measured by the Leiter-R at the Indicated Time Points|he Leiter International Performance Scale or simply Leiter is an intelligence test for children and adolescents, with norms ranging from 2 to 20 years. For all ages, it yields an intelligence quotient (IQ) and a measure of logical ability. It is comprised of ten subtests, seven of which were relevant to the 12-18 years age group. The administration time was approximately 40 minutes. During the study, only the parent/caregiver completed this questionnaire while the participants were within the age range (i.e. <20 years). Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). The parent study did not measure baseline cognition, behavior, and learning so changes from baseline were not available for participants in this study.|Baseline, Eligibility Assessment (Visit 1) up to 178 days|All Subjects Population|||||
672825|NCT01668654|Primary|Changes From Baseline in Bladder Volume as Assessed by the Post Void Residual (PVR) Ultrasound at the Indicated Time Points|The PVR urine test measured the amount of urine left in the bladder after urination. The PVR bladder ultrasound was performed by an urologist, a qualified technician or by an appropriately trained qualified study nurse at Visits 1, 6, and the EW Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 6, EW Visit|All Subjects Population|||||
673033|NCT01665807|Secondary|Acceptability of Vaccine|The post-vaccination (Day 0) and follow-up (Day 8) questionnaires include questions on the participant's preference for intradermal or intramuscular injections and questions about their preference for administration by a healthcare provider or self-vaccination.|Follow up (Day 8)||||||
672827|NCT01668654|Primary|Change From Baseline in the Red Blood Cell Count Measurements at the Indicated Time Points|Clinical laboratory assessments included hematology, chemistry and urinalysis parameters. The red blood cell count was measured at Visits 1, 4, 5, 6, 7, EW and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population|||||
672828|NCT01668654|Primary|Change From Baseline in Mean Corpuscle Hemoglobin at the Indicated Time Points|Clinical laboratory assessments included hematology, chemistry and urinalysis parameters. Mean corpuscle hemoglobin was measured at Visits 1, 4, 5, 6, 7, EW and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population|||||
672829|NCT01668654|Primary|Change From Baseline in the Mean Corpuscle Volume and Mean Platelet Volume Measurements at the Indicated Time Points|Clinical laboratory assessments included hematology, chemistry and urinalysis parameters. Mean corpuscle volume and mean platelet colume parameters were measured at Visits 1, 4, 5, 6, 7, EW and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population|||||
672830|NCT01668654|Primary|Change From Baseline in the Hematocrit Measurements at the Indicated Time Points|Clinical laboratory assessments included hematology, chemistry and urinalysis parameters. Hematocrit was measured at Visits 1, 4, 5, 6, 7, EW and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population|||||
672831|NCT01668654|Primary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Segmented Neutrophils, Total Neutrophils, and Red Cell Distribution Width (RDW) Percentages at the Indicated Time Points|Clinical laboratory assessments included hematology, chemistry and urinalysis parameters. Basophils, eosinophils, lymphocytes, monocytes, segmented neutrophils, total neutrophils and red cell distribution width (RDW) parameters were measured at Visits 1, 4, 5, 6, 7, EW and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population|||||
672832|NCT01668654|Primary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Segmented Neutrophils, Total Neutrophils, and White Blood Cell Count Measurements at the Indicated Time Points|Clinical laboratory assessments included hematology, chemistry and urinalysis parameters. Basophils, eosinophils, lymphocytes, monocytes, platelet count, segmented neutrophils, total neutrophils (Total absolute neutrophil count- total ANC), and white blood cell count parameters were measured at Visits 1, 4, 5, 6, 7, EW and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population|||||
672833|NCT01668654|Primary|Change From Baseline in Thyroid Stimulating Hormone (TSH) and Urine Albumin Measurements at the Indicated Time Points|Clinical laboratory assessments included measurements of endocrine and urinalysis parameters. TSH and urine albumin parameters were measured at Visits 1, 4, 5, 6, 7, EW and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population|||||
672834|NCT01668654|Primary|Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Uric Acid, and Urine Creatinine Concentration Measurements at the Indicated Time Points|Clinical laboratory assessments included hematology, chemistry and urinalysis parameters. Creatinine, direct bilirubin, indirect bilirubin, total bilirubin, uric acid, and urine creatinine concentration parameters were measured at Visits 1, 4, 5, 6, 7, EW and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population|||||
672927|NCT01667731|Primary|Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants who were enrolled and received at least 1 dose of study drug||percentage of participants|||Number
673034|NCT01665807|Primary|Time to Administer Influenza Vaccine (in Seconds)|Time required to explain vaccination, obtain consent, administer vaccine, and register vaccination|Vaccination (Day 0)|||seconds||Full Range|Median
672835|NCT01668654|Primary|Change From Baseline in Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Magnesium, Inorganic Phosphorus, Potassium, Sodium, and Urea/BUN Measurements at the Indicated Time Points|Clinical laboratory assessments included hematology, chemistry and urinalysis parameters. Calcium, carbon dioxide content/bicarbonate, chloride, cholesterol, glucose, magnesium, inorganic phosphorus, potassium, sodium, and urea/BUN parameters were measured at Visits 1, 4, 5, 6, 7, EW and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population|||||
672836|NCT01668654|Primary|Change From Baseline in the BUN/Creatinine and the Urine Albumin/Creatinine Ratios at the Indicated Time Points|Clinical laboratory assessments included hematology, chemistry and urinalysis parameters. Blood Urea Nitrogen (BUN)/Creatinine and Urine Albumin/Creatinine were measured at Visits 1, 4, 5, 6, 7, EW and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population|||||
672837|NCT01668654|Primary|Change From Baseline in Albumin, Total Protein, Hemoglobin, and Mean Corpuscle Hemoglobin Measurements at the Indicated Time Points|Clinical laboratory assessments included hematology, chemistry and urinalysis parameters. Albumin, total protein, hemoglobin, and mean corpuscle hemoglobin concentration parameters were measured at Visits 1, 4, 5, 6, 7, EW and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population|||||
672838|NCT01668654|Primary|Change From Baseline in ALT, ALP, AST, CK, and LDH Measurements at the Indicated Time Points|Clinical laboratory assessments included hematology, chemistry and urinalysis parameters. Alanine amino transferase (ALT), alkaline phosphotase (ALP), aspartate amino transferase (AST), creatine kinase (CK), and lactate dehydrogenase (LDH) parameters were measured at Visits 1, 4, 5, 6, 7, EW and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population|||||
672839|NCT01668654|Primary|Number of Participants With Abnormal Clinically Significant ECG Findings Based on Investigator Judgment at Anytime During the Study|The 12-lead ECG was recorded in a supine position at the Eligibility Assessment Visit andthe EW Visit after having kept a participant at rest in this position for 10 minutes. Abnormal findings were analyzed as clinically significant (CS) and not clinically significant (NCS). The study investigator judged the ECG abnormailities as CS or NCS.|Eligibility Assessment and EW Visit|All Subjects Population||Participants|||Number
672840|NCT01668654|Primary|Change From Baseline in Electrocardiogram (ECG) at the Indicated Time Points|The 12-lead ECG was recorded in a supine position at the Eligibility Assessment Visitand the EW Visit after having kept a participant at rest in this position for 10 minutes. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), EW Visit (up to 178 days)|All Subjects Population|||||
672841|NCT01668654|Primary|Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points|BMI is calculated as weight in kilograms (kg) divided by the square of their height in metres (m^2). BMI was measured at the following Visits: 1, 4, 5, 6, 7, EW and FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population|||||
672842|NCT01668654|Primary|Change From Baseline in Body Weight at the Indicated Time Points|Body weight was measured without shoes and wearing light clothing at the following Visits: 1, 4, 5, 6, 7, EW and FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population|||||
672843|NCT01668654|Primary|Change From Baseline in Body Height at Indicated Time Points|Body height was measured without shoes and wearing light clothing at the following Visits: 1, 4, 5, 6, 7, EW and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population|||||
672928|NCT01667679|Secondary|Number of Participants With the Indicated Concomitant Medications|Concomitant medications are defined as non-study medications with a start or stop date between the first dose of study medication and the end of safety follow-up, inclusive. Derm. = dermatologic; incl. - including.|up to 24 weeks|Safety Analysis Set||participants|||Number
672844|NCT01668654|Primary|Change From Baseline in Body Temperature at the Indicated Time Points|Vital sign assessment included body temperature measurements at the following Visits: 1, 4, 5, 6, 7, EW, and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population|||||
672845|NCT01668654|Primary|Change From Baseline in Heart Rate at the Indicated Time Points|Vital sign assessment included heart rate measured at the following Visits: 1, 4, 5, 6, 7, EW, and the FU Visit after the participant was in seated position for 5 minutes. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population|||||
672846|NCT01668654|Primary|Change From Baseline in SBP and DBP at the Indicated Time Points|Vital sign assessment included SBP and DBP measurements. SBP and DBP were measured at the following Visits: 1, 4, 5, 6, 7, EW, and the FU Visit after the participant was in seated position for 5 minutes. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population|||||
672847|NCT01668654|Primary|Number of Participants With Vital Signs Outside the Pre-determined Clinically Important Findings or Outside the Normal Ranges at Any Time During the Study|Vital sign assessment included systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate and body temperature measurements. SBP, DBP and heart rate were measured at the following Visits: 1, 4, 5, 6, 7, EW and the FU Visit after the participants were in the seated position for 5 minutes.|Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population||Participants|||Number
672848|NCT01668654|Primary|Number of Participants With AEs Leading to Withdrawal|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of the study medication, whether or not considered related to the study medication. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations. Please refer to the AE/SAE module for a list of non-serious AEs and SAE.|From the start of study medication until the end of the Follow-Up Visit (up to 178 days)|All Subjects Population||Participants|||Number
672849|NCT01668654|Primary|Number of Participants (Par.) With Any Adverse Event (AE) or Serious Adverse Event (SAE) During the Treatment Period|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of the study medication, whether or not considered related to the study medication. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations. Please refer to the AE/SAE module for a list of non-serious AEs and SAE.|From the start of study medication until the end of Follow-Up (up to 178 days)|All Subjects Population: all participants who enrolled in the study.||Participants|||Number
672850|NCT01668628|Secondary|The Association Between Hydration Status and Depression and Quality of Life in Hemodialysis Patients|Quality of life was measured via scores of KDQOL SF1.3. Hydration status was measured via body composition monitor as an Overhydration (OH) value Depression was assessed using Beck depression inventory (BDI) score|Visit 1(zero month) and Visit 2 (12 months after Visit 1)|Only prevalent hemodialysis dialysis participants with complete baseline hydration status and scale scores were assessed for this Outcome Measure.||units on a scale||Standard Deviation|Mean
672851|NCT01668628|Secondary|The Association Between Hydration Status and Depression and Quality of Life in Peritoneal Dialysis Patients|"Hydration status is checked via BCM(body composition monitor) at Visit 1 and Visit 2 period, as a Overhydration(OH) value.
Health-related quality of life (HRQOL) is measured via scores of KDQOL SF1.3. Depression was assessed using Beck Depression Inventory (BDI) score. Visit 2 period is followed 12 months after Visit 1 period. HRQOL is assessed by three components; physical health score, mental health score and kidney disease health score.
Physical health score, mental health score and kidney disease health score are averaged scores of subscales.
The range of each score and each subscale are 0 - 100, and higher values indicate better HRQOL status.
The BDI score is a summed score of each component of BDI questionnaire, and the range is 5 to 63. Higher BDI scores are considered to represent more severe depression symptoms.
The outcome measure is the averaged scores at Visit 1 between the Normohydration group and Overhydration group."|Visit 1(zero month) and Visit 2 (12 months after Visit 1)|PD participants with OH value, HRQOL scores and BDI scores at visit 1 and visit 2 were assessed for this Outcome Measure.||units on a scale||Standard Deviation|Mean
672871|NCT01668017|Secondary|Apparent Volume of Distribution at Terminal Phase (Vz/f) of Pimasertib on Cycle 1 Day 15|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution after oral dose (Vz/f) was influenced by the fraction absorbed. Data were not reported for “Part 1: Pimasertib 45 mg In HCC” arm as there were no PK samples collected for this arm.|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 15|PK analysis set. Here “Overall Number of Participants Analyzed” signifies the overall number of subjects who were evaluable for this outcome measure for each arm, respectively.||liters||Geometric Coefficient of Variation|Geometric Mean
678088|NCT01601977|Secondary|Health Related Quality of Life|Severe Respiratory Insufficiency (SRI) questionnaire. Higher scores indicate better quality of life (minimum 0, maximum 100)|6 weeks|||units on a scale||Standard Deviation|Mean
672852|NCT01668628|Primary|Change of Kidney Disease Quality of Life Short Form 1.3 (KDQOL SF 1.3) Score and Beck Depression Inventory(BDI) Score From Visit 1 Period|"Health-related quality of life (HRQOL) is assessed via KDQOL SF 1.3 and depression is assessed via BDI at the visit 1 and Visit 2 period.
KDQOL SF 1.3 and BDI are validated questionnaires to assess HRQOL and depression, respectively.
Visit 2 period is followed 12 months after Visit 1 period. The outcome measure is the difference in averaged scores between Visit 1 and Visit 2; It is calculated as (Score at visit 2 - Score at visit 1).
HRQOL is assessed by three components; physical health score, mental health score and kidney disease health score.
Physical health score, mental health score and kidney disease health score are averaged scores of subscales.
The range of each score and each subscale are 0 - 100, and higher values indicate better HRQOL status.
The BDI score is a summed score of each component of BDI questionnaire, and the range is 5 to 63. Higher BDI scores are considered to represent more severe depression symptoms."|Visit 1(zero month) and Visit 2 (12 months after Visit 1)|5 subjects in Incident PD patients and 2 subjects in Prevalent HD patients are excluded due to protocol violation.||units on a scale||Standard Deviation|Mean
672853|NCT01668589|Secondary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 24 Months|Bone mineral density was measured using dual energy X-ray absorptiometry (DXA).|Baseline and Month 24|Full analysis set with a baseline value and a month 24 value measured with the same machine type.||percent change||Standard Deviation|Mean
672854|NCT01668589|Secondary|Percent Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at 24 Months|Bone mineral density was measured using dual energy X-ray absorptiometry (DXA).|Baseline and Month 24|Full analysis set with a baseline value and a month 24 value measured with the same body side and machine type.||percent change||Standard Deviation|Mean
672855|NCT01668589|Secondary|Percent Change From Baseline in Total Hip Bone Mineral Density (BMD) at 24 Months|Bone mineral density was measured using dual energy X-ray absorptiometry (DXA).|Baseline and Month 24|Full analysis set with a baseline value and a month 24 value measured with the same machine type.||percent change||Standard Deviation|Mean
672856|NCT01668589|Secondary|Percentage of Participants Who Received Denosumab Injections Within the Specified Window|The percentage of participants who received 0, 1, 2, or 3 denosumab injections within the specified window (defined by the persistence definition as 6 months + 8 weeks). The number of injections that a participant took during the 2-year period after the first pre-enrolment injection, and that were given within the appropriate window from the previous injection, irrespective of when the previous injection was given. Only the first 3 post-baseline injections are considered.|24 months|Full analysis set||percentage of participants|||Number
672857|NCT01668589|Secondary|Time to Non-persistence With Denosumab Injection|Time to non-persistence for non-persistent patients was calculated as the time between the date of the first denosumab injection and the date of last denosumab injection received during the period where the patient was still classified as persistent, plus 6 months (183 days). Participants were considered persistent at 24 months if they received at least 4 injections, including the baseline injection, with no more than 6 months + 8 weeks apart between any 2 consecutive injections.|24 months|Full analysis set who were non-persistent at 24 months||months||Inter-Quartile Range|Median
672858|NCT01668589|Primary|Medication Coverage Ratio (MCR) for Denosumab Injection at 12 Months and 24 Months|"MCR at 12 months was defined as the accumulative number of days covered with denosumab treatment during the first 12 months divided by 366 days, expressed as a percentage.
MCR at 24 months was defined as the accumulative number of days covered with denosumab treatment during the first 24 months divided by 732 days, expressed as a percentage.
It was assumed that each injection of denosumab treatment provided 6 months of coverage (or 183 days) from the date of injection or until the date of the next injection, whichever comes first. So, a participant who received only 1 injection in the first year would have MCR at 12 months equal to 50%."|From baseline to 12 months and 24 months|Full analysis set||percentage of days of coverage||95% Confidence Interval|Mean
672859|NCT01668589|Primary|Percentage of Participants Adherent to Denosumab Injection at 12 Months and 24 Months|"A participant was considered adherent to denosumab at 12 months if they received at least 1 denosumab injection over the 12-month period following the pre-enrolment denosumab injection, with the time between any 2 consecutive injections being at most 6 months ± 4 weeks (between 155 and 211 days apart).
A participant was considered adherent to denosumab at 24 months if they received at least 3 denosumab injections over the 24-month period following the pre-enrolment denosumab injection, with the time between any 2 consecutive injections being at most 6 months ± 4 weeks (between 155 and 211 days apart)."|12 months and 24 months|Full analysis set||percentage of participants||95% Confidence Interval|Number
672860|NCT01668589|Primary|Percentage of Participants Persistent With Denosumab Injections at 12 Months and 24 Months|"A participant was considered persistent with denosumab at 12 months if they received at least 1 denosumab injection following the pre-enrolment denosumab injection no later than 6 months + 8 weeks (ie, no greater than 239 days apart).
A participant was considered persistent with denosumab at 24 months if they received at least 3 denosumab injections following the pre-enrolment denosumab injection, and the length of time between any 2 consecutive denosumab injections did not exceed 6 months + 8 weeks (ie, no greater than 239 days apart)."|12 months and 24 months|Full analysis set||percentage of participants||95% Confidence Interval|Number
672861|NCT01668173|Primary|Overall Objective Response|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|6 months|||participant with Stable Disease|||Number
672862|NCT01668030|Primary|Time to Wound Epithelialization|Time it required the subjects treated with two standard ointments to establish a wound bed.|Two years|||days|cheeks (side of face)||Number
672872|NCT01668017|Secondary|Apparent Volume of Distribution at Terminal Phase (Vz/f) Part 1: Pimasertib 45 mg in HCC Arm on Cycle 1 Day 1|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. The summarized data was not available for this arm therefore individual data was presented.|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 1|PK analysis set included all subjects who received at least 1 planned dose of pimasertib and who had at least 1 measurable post-dose concentration. Subjects with important protocol deviations or events, which may impact the quality of the PK data were excluded from the PK analysis set.||liters|||Number
672863|NCT01668017|Secondary|Percentage of Subjects With Disease Control|Percentage of subjects with disease control (CR plus PR plus greater than 12 weeks SD) according to RECIST Version 1.1 was reported CR was defined as disappearance of all target and all non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or unequivocal progression of existing non-target lesions.|Day 1 of Cycle 3 and Day 1 of every alternate until end of treatment (up to a maximum of 35.4 weeks)|Efficacy analysis set included all subjects who received at least one administration of planned dose of pimasertib and who have had at least one efficacy assessment after the first dose.||percentage of subjects|||Number
672864|NCT01668017|Secondary|Percentage of Subjects With Objective Response|Percentage of subjects with objective response (CR plus PR) according to RECIST Version 1.1 was reported. CR was defined as disappearance of all target and all non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters.|Day 1 of Cycle 3 and Day 1 of every alternate until end of treatment (up to a maximum of 35.4 weeks)|Efficacy analysis set’ included all subjects who received at least one administration of planned dose of pimasertib and who have had at least one efficacy assessment after the first dose.||percentage of subjects|||Number
672865|NCT01668017|Secondary|Percentage of Subjects With Best Overall Response|Percentage of subjects with best overall response in each category (complete response [CR], partial response [PR], stable disease [SD], progressive disease [PD]) according to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) was reported. CR was defined as disappearance of all target and all non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or unequivocal progression of existing non-target lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|Day 1 of Cycle 3 and Day 1 of every alternate until end of treatment (up to a maximum of 35.4 weeks)|Efficacy analysis set included all subjects who received at least one administration of planned dose of pimasertib and who have had at least one efficacy assessment after the first dose.||percentage of subjects|||Number
672866|NCT01668017|Secondary|Accumulation Ratio for Cmax Racc(Cmax) of Part 1: Pimasertib 30 mg In HCC Arm|Racc (Cmax) was calculated as, maximum observed plasma concentration on Day 1 (Cmax) divided by maximum observed plasma concentration on Day 15 (Cmax).|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 1 and Day 15|PK analysis set included all subjects who received at least 1 planned dose of pimasertib and who had at least 1 measurable post-dose concentration. Subjects with important protocol deviations or events, which may impact the quality of the PK data were excluded from the PK analysis set.||ratio|||Number
672867|NCT01668017|Secondary|Accumulation Ratio for Cmax Racc(Cmax) of Pimasertib|Racc (Cmax) was calculated as, maximum observed plasma concentration on Day 1 (Cmax) divided by maximum observed plasma concentration on Day 15 (Cmax). Data were not reported for “Part 1: Pimasertib 45 mg In HCC” arm as there were no PK samples collected for this arm.|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 1 and Day 15|PK analysis set. Here “Overall Number of Participants Analyzed” signifies the overall number of subjects who were evaluable for this outcome measure for each arm, respectively.||ratio||Geometric Coefficient of Variation|Geometric Mean
672868|NCT01668017|Secondary|Accumulation Ratio for AUC Racc(AUC) of Part 1: Pimasertib 30 mg In HCC Arm|Racc (AUC) was calculated as, area under the curve from time zero to end of dosing interval on Day 1 divided by area under the curve from time zero to end of dosing interval on Day 15.|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 1 and Day 15|PK analysis set included all subjects who received at least 1 planned dose of pimasertib and who had at least 1 measurable post-dose concentration. Subjects with important protocol deviations or events, which may impact the quality of the PK data were excluded from the PK analysis set.||ratio|||Number
672869|NCT01668017|Secondary|Accumulation Ratio for AUC Racc(AUC) of Pimasertib|Racc (AUC) was calculated as, area under the curve from time zero to end of dosing interval on Day 1 divided by area under the curve from time zero to end of dosing interval on Day 15. Data were not reported for “Part 1: Pimasertib 45 mg In HCC” arm as there were no PK samples collected for this arm.|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 1 and Day 15|PK analysis set. Here “Overall Number of Participants Analyzed” signifies the overall number of subjects who were evaluable for this outcome measure for each arm, respectively.||ratio||Geometric Coefficient of Variation|Geometric Mean
672870|NCT01668017|Secondary|Apparent Volume of Distribution at Terminal Phase (Vz/f) of Part 1: Pimasertib 30 mg in HCC Arm on Cycle 1 Day 15|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. The summarized data was not available for this arm therefore individual data was presented.|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 15|PK analysis set included all subjects who received at least 1 planned dose of pimasertib and who had at least 1 measurable post-dose concentration. Subjects with important protocol deviations or events, which may impact the quality of the PK data were excluded from the PK analysis set.||liters|||Number
672895|NCT01668017|Secondary|Maximum Observed Concentration (Cmax) of Pimasertib on Cycle 1 Day 1||Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 1|Pharmacokinetic (PK) analysis set included all subjects who received at least 1 planned dose of pimasertib and who had at least 1 measurable post-dose concentration. Subjects with important protocol deviations or events, which may impact the quality of the PK data were excluded from the PK analysis set.||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
672873|NCT01668017|Secondary|Apparent Volume of Distribution at Terminal Phase (Vz/f) of Pimasertib on Cycle 1 Day 1|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution after oral dose (Vz/f) was influenced by the fraction absorbed.|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 1|PK analysis set. Here “Overall Number of Participants Analyzed” signifies the overall number of subjects who were evaluable for this outcome measure for each arm, respectively.||liters||Geometric Coefficient of Variation|Geometric Mean
672874|NCT01668017|Secondary|Apparent Clearance at Steady-state (CLss/f) of Part 1: Pimasertib 30 mg in HCC Arm on Cycle 1 Day 15|Apparent clearance at steady state was reported. Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. The summarized data was not available for this arm therefore individual data was presented.|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 15|PK analysis set included all subjects who received at least 1 planned dose of pimasertib and who had at least 1 measurable post-dose concentration. Subjects with important protocol deviations or events, which may impact the quality of the PK data were excluded from the PK analysis set.||L/h|||Number
672875|NCT01668017|Secondary|Apparent Clearance at Steady-state (CLss/f) of Pimasertib on Cycle 1 Day 15|Apparent clearance at steady state was reported. Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Data were not reported for “Part 1: Pimasertib 45 mg In HCC” arm as there were no PK samples collected for this arm.|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 15|PK analysis set. Here “Overall Number of Participants Analyzed” signifies the overall number of subjects who were evaluable for this outcome measure for each arm, respectively.||L/h||Geometric Coefficient of Variation|Geometric Mean
672876|NCT01668017|Secondary|Apparent Clearance (CL/f) of Part 1: Pimasertib 45 mg in HCC Arm on Cycle 1 Day 1|Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent clearance after oral dose (CL/f) is influenced by the fraction absorbed. The summarized data was not available for this arm therefore individual data was presented.|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 1|PK analysis set included all subjects who received at least 1 planned dose of pimasertib and who had at least 1 measurable post-dose concentration. Subjects with important protocol deviations or events, which may impact the quality of the PK data were excluded from the PK analysis set.||L/h|||Number
672877|NCT01668017|Secondary|Apparent Clearance (CL/f) of Pimasertib on Cycle 1 Day 1|Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent clearance after oral dose (CL/f) is influenced by the fraction absorbed.|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 1|PK analysis set. Here “Overall Number of Participants Analyzed” signifies the overall number of subjects who were evaluable for this outcome measure for each arm, respectively.||liter/hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
672878|NCT01668017|Secondary|Apparent Terminal Half-life (t1/2) of Part 1: Pimasertib 30 mg in HCC Arm on Cycle 1 Day 15|The apparent terminal half-life was defined as the time required for the plasma concentration of drug to decrease 50% in the final stage of its elimination. The summarized data was not available for this arm therefore individual data was presented.|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 15|PK analysis set included all subjects who received at least 1 planned dose of pimasertib and who had at least 1 measurable post-dose concentration. Subjects with important protocol deviations or events, which may impact the quality of the PK data were excluded from the PK analysis set.||hours|||Number
672879|NCT01668017|Secondary|Apparent Terminal Half-life (t1/2) of Pimasertib on Cycle 1 Day 15|The apparent terminal half-life was defined as the time required for the plasma concentration of drug to decrease 50% in the final stage of its elimination. Data were not reported for “Part 1: Pimasertib 45 mg In HCC” arm as there were no PK samples collected for this arm.|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 15|PK analysis set. Here “Overall Number of Participants Analyzed” signifies the overall number of subjects who were evaluable for this outcome measure for each arm, respectively.||hours||Full Range|Median
672880|NCT01668017|Secondary|Apparent Terminal Half-life (t1/2) of Part 1: Pimasertib 45 mg in HCC Arm on Cycle 1 Day 1|The apparent terminal half-life was defined as the time required for the plasma concentration of drug to decrease 50% in the final stage of its elimination. The summarized data was not available for this arm therefore individual data was presented.|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 1|PK analysis set included all subjects who received at least 1 planned dose of pimasertib and who had at least 1 measurable post-dose concentration. Subjects with important protocol deviations or events, which may impact the quality of the PK data were excluded from the PK analysis set.||hours|||Number
672881|NCT01668017|Secondary|Apparent Terminal Half-life (t1/2) of Pimasertib on Cycle 1 Day 1|The apparent terminal half-life was defined as the time required for the plasma concentration of drug to decrease 50% in the final stage of its elimination.|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 1|PK analysis set. Here “Overall Number of Participants Analyzed” signifies the overall number of subjects who were evaluable for this outcome measure for each arm, respectively.||hours||Full Range|Median
672882|NCT01668017|Secondary|Area Under the Concentration-Time Curve From Time Zero up to Time Tau (AUC0-tau) of Part 1: Pimasertib 30 mg in HCC Arm on Cycle 1 Day 15|Area under the concentration-time curve from time zero up to time Tau, where Tau is the dosing interval (12 hours). The summarized data was not available for this arm therefore individual data was presented.|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 15|PK analysis set included all subjects who received at least 1 planned dose of pimasertib and who had at least 1 measurable post-dose concentration. Subjects with important protocol deviations or events, which may impact the quality of the PK data were excluded from the PK analysis set.||h*ng/mL|||Number
672923|NCT01667731|Secondary|Change From Baseline in HCV RNA at Week 2||Baseline; Week 2|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
672883|NCT01668017|Secondary|Area Under the Concentration-Time Curve From Time Zero up to Time Tau (AUC0-tau) of Pimasertib at Cycle 1 Day 15|Area under the concentration-time curve from time zero up to time Tau, where Tau is the dosing interval (12 hours). Data were not reported for “Part 1: Pimasertib 45 mg In HCC” arm as there were no PK samples collected for this arm.|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 15|PK analysis set. Here “Overall Number of Participants Analyzed” signifies the overall number of subjects who were evaluable for this outcome measure for each arm, respectively.||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
672884|NCT01668017|Secondary|Area Under the Concentration-Time Curve From Time Zero up to Time Tau (AUC0-tau) of Pimasertib of 1 Part 1: Pimasertib 45 mg in HCC Arm on Cycle 1 Day 1|Area under the concentration-time curve from time zero up to time Tau, where Tau is the dosing interval (12 hours). The summarized data was not available for this arm therefore individual data was presented.|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 1|PK analysis set included all subjects who received at least 1 planned dose of pimasertib and who had at least 1 measurable post-dose concentration. Subjects with important protocol deviations or events, which may impact the quality of the PK data were excluded from the PK analysis set.||h*ng/mL|||Number
672885|NCT01668017|Secondary|Area Under the Concentration-Time Curve From Time Zero up to Time Tau (AUC0-tau) of Pimasertib at Cycle 1 Day 1|Area under the concentration-time curve from time zero up to time Tau, where Tau is the dosing interval (12 hours).|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 1|PK analysis set. Here “Overall Number of Participants Analyzed” signifies the overall number of subjects who were evaluable for this outcome measure for each arm, respectively.||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
672886|NCT01668017|Secondary|Area Under the Concentration Over Time (AUCt) of Part 1: Pimasertib 45 mg in HCC Arm on Cycle 1 Day 1|The summarized data was not available for this arm therefore individual data was presented.|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 1|PK analysis set included all subjects who received at least 1 planned dose of pimasertib and who had at least 1 measurable post-dose concentration. Subjects with important protocol deviations or events, which may impact the quality of the PK data were excluded from the PK analysis set.||h*ng/mL|||Number
672887|NCT01668017|Secondary|Area Under the Concentration Over Time (AUCt) at Cycle 1 Day 1||Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 1|PK analysis set included all subjects who received at least 1 planned dose of pimasertib and who had at least 1 measurable post-dose concentration. Subjects with important protocol deviations or events, which may impact the quality of the PK data were excluded from the PK analysis set.||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
672888|NCT01668017|Secondary|Time to Reach Maximum Concentration (Tmax) of Part 1: Pimasertib 30 mg in HCC Arm on Cycle 1 Day 15|The summarized data was not available for this arm therefore individual data was presented.|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 15|PK analysis set included all subjects who received at least 1 planned dose of pimasertib and who had at least 1 measurable post-dose concentration. Subjects with important protocol deviations or events, which may impact the quality of the PK data were excluded from the PK analysis set.||hours|||Number
672889|NCT01668017|Secondary|Time to Reach Maximum Concentration (Tmax) on Cycle 1 Day 15|Data were not reported for “Part 1: Pimasertib 45 mg In HCC” arm as there were no PK samples collected for this arm.|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 15|PK analysis set. Here “Overall Number of Participants Analyzed” signifies the overall number of subjects who were evaluable for this outcome measure for each arm, respectively.||hours||Full Range|Median
672890|NCT01668017|Secondary|Time to Reach Maximum Concentration (Tmax) of Part 1: Pimasertib 45 mg in HCC Arm on Cycle 1 Day 1|The summarized data was not available for this arm therefore individual data was presented.|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 1|PK analysis set included all subjects who received at least 1 planned dose of pimasertib and who had at least 1 measurable post-dose concentration. Subjects with important protocol deviations or events, which may impact the quality of the PK data were excluded from the PK analysis set.||hours|||Number
672891|NCT01668017|Secondary|Time to Reach Maximum Concentration (Tmax) on Cycle 1 Day 1||Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 1|PK analysis set included all subjects who received at least 1 planned dose of pimasertib and who had at least 1 measurable post-dose concentration. Subjects with important protocol deviations or events, which may impact the quality of the PK data were excluded from the PK analysis set.||hours||Full Range|Median
672892|NCT01668017|Secondary|Maximum Observed Concentration (Cmax) of Part 1: Pimasertib 30 mg in HCC Arm on Cycle 1 Day 15|The summarized data was not available for this arm therefore individual data was presented.|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 15|PK analysis set included all subjects who received at least 1 planned dose of pimasertib and who had at least 1 measurable post-dose concentration. Subjects with important protocol deviations or events, which may impact the quality of the PK data were excluded from the PK analysis set.||ng/mL|||Number
672893|NCT01668017|Secondary|Maximum Observed Concentration (Cmax) of Pimasertib on Cycle 1 Day 15|Data were not reported for “Part 1: Pimasertib 45 mg in HCC” arm as there were no PK samples collected for this arm.|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 15|PK analysis set. Here “Overall Number of Participants Analyzed” signifies the overall number of subjects who were evaluable for this outcome measure for each arm, respectively.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
672894|NCT01668017|Secondary|Maximum Observed Concentration (Cmax) of Part 1: Pimasertib 45 mg in HCC Arm on Cycle 1 Day 1|The summarized data was not available for this arm therefore individual data was presented.|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 1|PK analysis set included all subjects who received at least 1 planned dose of pimasertib and who had at least 1 measurable post-dose concentration. Subjects with important protocol deviations or events, which may impact the quality of the PK data were excluded from the PK analysis set.||ng/mL|||Number
672924|NCT01667731|Secondary|Change From Baseline in HCV RNA at Week 1||Baseline; Week 1|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
672896|NCT01668017|Secondary|Number of Subjects Who Experienced Treatment-Emergent Adverse Events (TEAEs) or Serious TEAEs|An adverse event (AE) was defined as any untoward medical occurrence which does not necessarily have a causal relationship with this the study drug. An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. TEAEs include both Serious TEAEs and non-serious TEAEs.|Baseline up to 30 days post last dose of study drug; assessed maximum up to 39.4 weeks|Safety analysis set included all subjects who received at least one administration of pimasertib.||subjects|||Number
672897|NCT01668017|Primary|Number of Subjects Who Experienced at Least One Dose Limiting Toxicity (DLT)|DLT defined using National Cancer Institute Common Toxicity Criteria for Adverse Events Version 3.0 (NCI CTCAE v3.0): any of following toxicities possibly/probably related to study drug: Any non-hematological toxicity of Grade 3 or higher (excluding Grade 3 asymptomatic rise in liver function tests (aspartate aminotransferase [AST], alanine aminotransferase [ALT], alkaline phosphatase [ALP], gamma-glutamyl transferase [GGT] reversible in 7 days for subjects with solid tumor and without liver involvement, or Grade 4 for subjects with HCC or with liver involvement; Grade 3 or 4 asymptomatic rise in creatinine phosphokinase (CPK) reversible in 7 days, deniable for myocardial infarction and rhabdomyolysis; Grade 3 vomiting/diarrhea encountered without optimal therapy). Any Grade 4 neutropenia >5 days duration, any Grade 3 or above febrile neutropenia. Grade 4 thrombocytopenia >1 day or Grade 3 with bleeding. Any treatment delay >2 weeks due to drug-related adverse effects.|During Treatment Cycle 1 (Day 1 to 21)|DLT analysis set included all subjects who experienced any DLT during Cycle 1 and who received above 85% of all planned doses of pimasertib during Cycle 1.||subjects|||Number
672898|NCT01668004|Secondary|Percentage of Ankylosing Spondylitis Disease Activity Score (ASDAS) Responders Following Treatment With GLM|The percentage of participants with ASDAS clinically important improvement (ASDAS-CII; ≥ 1.1 units) and major improvement (ASDAS-MI; ≥ 2.0 units) at 3 months were determined. The ASDAS incorporates three items from the BASDAI (spinal pain, duration of morning stiffness, and peripheral joint pain or swelling) each assessed on a VAS (0 to 10 cm; increasing severity) as well as patient global assessment of disease activity (VAS; 0 to 10 cm; increasing severity) and a laboratory measure of inflammation (CRP level [mg/L] or ESR [mm/hr]). ASDAS was calculated using the formula: 0.12*Spinal Pain + 0.06*Duration of Morning Stiffness + 0.11*Patient Global + 0.07*Peripheral Pain/Swelling + 0.58*ln(CRP (mg/L) +1). A decrease in ASDAS at 3 months relative to BL signifies an improvement in physical function; ASDAS-MI (≥ 2.0 units decrease from BL) signifies a comparatively greater improvement in physical function than ASDAS-CII (≥ 1.1 units decrease from BL).|BL, Study Month 3|All participants who received at least 3 months of GLM in the study and at least 3 months of follow-up data available for analysis of the endpoint (ASDAS).||Percentage of participants|||Number
672899|NCT01668004|Secondary|Percentage of Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI 50) Responders Following Treatment With GLM|The percentage of participants with a BASDAI 50 response (defined as a 50% improvement or as an absolute improvement of 2 points in their BASDAI physical function score) at three months was determined. The BASDAI consists of total of six visual analog scales (VAS): five VAS (0 to 10 cm; increasing severity) measuring severity of fatigue, spinal pain, peripheral joint pain or swelling, localized tenderness, and severity of morning stiffness and one VAS (0 to 10 cm; increasing duration up to 2 hours) measuring duration of morning stiffness. The morning stiffness scores are averaged and summed with the scores for the remaining four items resulting in a composite score (0-50); the final BASDAI score (0-10) is derived by dividing by 5.|Baseline (BL), Study Month 3|All participants who received at least 3 months of GLM in the study and at least 3 months of follow-up data available for analysis of the endpoint (BASDAI 50).||Percentage of participants|||Number
672900|NCT01668004|Secondary|Annual Incidence Rate of New-Onset or Flares of Inflammatory Bowel Disease (IBD) and Psoriasis in Participants Before Anti-TNF/GLM Treatment and After the Start of GLM Treatment|IBD (Crohn's disease or ulcerative colitis) and psoriaris are extra-articular manifestations of AS involving the intestinal tract and skin, respectively. The annual incidence rates of new-onset or flares of IBD and psoriasis were to be determined separately (i.e., for each condition) over two 1-year long periods: 1) the historical observation period consisting of the year before initial anti-TNF treatment (for anti-TNF experienced participants) or prior to first GLM dose (for anti-TNF naïve participants); and 2) the GLM observation period consisting of the year after first GLM dose.|Twelve Months Prior to Enrollment to Study Month 12|The incidence rates for new onset or flares of IBD and psoriasis could not be evaluated due to limitations of the data collected; occurrence of flares was not collected (specifically, history of IBD and/or psoriasis could not be distinguished from flares of IBD and/or psoriasis) and, therefore, results could not be determined.|||||
672901|NCT01668004|Primary|Annual Incidence Rate of New Uveitis Attacks in Participants Before Anti-TNF/GLM Treatment and After the Start of GLM Treatment|Uveitis is an extra-articular manifestation of AS involving inflammation of the eye. The annual incidence rate of new uveitis attacks was determined over two 1-year long periods: 1) the historical observation period consisting of the year before initial anti-TNF treatment (for anti-TNF experienced participants) or prior to first GLM dose (for anti-TNF naïve participants); and 2) the GLM observation period consisting of the year after first GLM dose. All participants were counted as contributing a full year of GLM exposure even if discontinuing early. Due to ongoing uveitis cases at time of period entry, participants did not have the same risk of new events during the one year periods. Participants with ongoing uveitis at start of GLM who had the adverse event for the entire treatment period were counted as having the 'new attack' before and no “new attack” after GLM treatment start.|Twelve Months Prior to Enrollment to Study Month 12|All participants who received at least 3 months of GLM in the study and at least 3 months of follow-up data available for analysis of the endpoint (incidence of uveitis). One participant for whom the timing of uveitis events could not be determined was excluded from the analysis.||Events per 100 participant years|||Number
685307|NCT01505374|Secondary|Preoperative and Postoperative Thigh Muscle Strength in Both Legs|This was measured with a dynamometer to gauge strength.|Up to postoperative day 2|||kilogram-force unit||Standard Deviation|Mean
672902|NCT01668004|Primary|Occurence Rate of Uveitis Attacks in Participants Before Anti-TNF/GLM Treatment and After the Start of GLM Treatment|Uveitis is an extra-articular manifestation of ankylosing spondylitis (AS) involving inflammation of the eye. The occurrence rate (assessed as present/absent) of uveitis attacks was determined over two 1-year long periods regardless of whether the event started during the assessed year: 1) the historical observation period consisting of the year before initial anti-TNF treatment (for anti-TNF experienced participants) or prior to first GLM dose (for anti-TNF naïve participants); and 2) the GLM observation period consisting of the year after first GLM dose.|Twelve Months Prior to Enrollment to Study Month 12|All participants who received at least 3 months of GLM in the study and at least 3 months of follow-up data available for analysis of the endpoint (occurence of uveitis).||Ratio|||Number
672903|NCT01667978|Primary|AUC Norethindrone|0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Day 21|following 21 days of continuous ingestion|2 withdrew because unable to present for study visit and another changed her medication||ng*h/mL||Full Range|Mean
672904|NCT01667926|Secondary|HDRS-28 Total|Hamilton Depression Rating Scale Total scores after completing 6 infusions. Scores may range from 0-81 with higher scores indicating greater depression severity. HDRS-28 score ≤ 7 was considered remission.|up to 5 months|||units on a scale||Standard Deviation|Mean
672905|NCT01667926|Primary|Hamilton Depression Rating Scale - Suicidal Ideation (HDRS-SI)|The HDRS-SI score consists of a single item on the Hamilton Depression Rating Scale (HDRS). Scores range from 0 to 4, with 0 representing no suicidal ideation, and 4 representing a suicide attempt.|up to 4 months|||units on a scale||Standard Deviation|Mean
672906|NCT01667900|Secondary|Part B - Pharmacodynamics: Area Under the Plasma Glucose Time Curve From Time Zero to 4 Hours Postmeal (gAUC[0-4])|Pharmacodynamic parameters were assessed at baseline and on Days 3, 24, and 29 in Part B.|Baseline and Days 3, 24, and 29|Participants in Part B who received at least 1 dose of study drug and had evaluable gAUC(0-4) data.||millimoles*hours per liter (mmol*h/L)||Standard Deviation|Mean
672907|NCT01667900|Primary|Pharmacokinetics: Half-life of Dulaglutide|Pharmacokinetic parameters were assessed on Day 1 in Part A and Days 1 and 22 in Part B.|Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose|Participants in Part A and Part B who received at least 1 dose of study drug and had evaluable half-life data.||hours||Full Range|Geometric Mean
672908|NCT01667900|Primary|Pharmacokinetics: Area Under the Concentration-time Curve From Time Zero to 336 Hours Postdose (AUC[0-336]) of Dulaglutide|Pharmacokinetic parameters were assessed on Day 1 in Part A and Days 1 and 22 in Part B.|Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose|Participants in Part A and Part B who received at least 1 dose of study drug and had evaluable AUC(0-336) data.||nanograms*hours per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
672909|NCT01667900|Primary|Pharmacokinetics: Time of Maximum Observed Concentration (Tmax) of Dulaglutide|Pharmacokinetic parameters were assessed on Day 1 in Part A and Days 1 and 22 in Part B.|Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose|Participants in Part A and Part B who received at least 1 dose of study drug and had evaluable Tmax data.||hours||Full Range|Median
672910|NCT01667900|Primary|Pharmacokinetics: Maximum Concentration (Cmax) of Dulaglutide|Pharmacokinetic parameters were assessed on Day 1 in Part A and Days 1 and 22 in Part B.|Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose|Participants in Part A and Part B who received at least 1 dose of study drug and had evaluable Cmax data.||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
672911|NCT01667848|Secondary|Core Temperature|core temperature during laparoscopic cholecystectomy using a rectal probe|during operation|||degree celsius||Standard Deviation|Mean
672912|NCT01667848|Primary|Pain (Rated With a Visual Analog Scale for Pain)|"postoperative pain (rated with a visual analog scale for pain) and analgesic requirements at operation day.
The visual analog scale for pain ranged from 0-10 (0 is no pain, 10 is Maximum of pain)"|first postoperative day|||units on a scale 0-10||Standard Deviation|Mean
672913|NCT01667848|Secondary|Core Temperature||one day postoperativly||||||
672914|NCT01667848|Primary|Pain (Rated With a Visual Analog Scale for Pain)|"postoperative pain (rated with a visual analog scale for pain) and analgesic requirements at operation day.
The visual analog scale for pain ranged from 0-10 (0 is no pain, 10 is Maximum of pain)"|operation day||||||
672915|NCT01667796|Secondary|Gene Expression Microarray|These data have not yet been generated|90 days||03/2017||||
672916|NCT01667796|Secondary|Cytokine Levels and Percentages of T and B Cells|These data have not yet been fully analyzed.|90 days||01/2018||||
672917|NCT01667796|Primary|Change in Mean Serum Level of 25-hydroxyvitamin D|Generalized estimating equations (GEE) with an autoregressive with lag one correlation matrix were used to compare the serially-measured serum 25(OH)D levels between MS patients and HCs to take into account repeated measures and within-subject correlations.|Baseline to 90 days|||nmol/L||Standard Deviation|Mean
672918|NCT01667731|Secondary|Percentage of Participants Experiencing Viral Relapse|Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) at end of treatment, but did not achieve an SVR.|Up to Posttreatment Week 24|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants|||Number
672919|NCT01667731|Secondary|Percentage of Participants Experiencing On-treatment Virologic Failure|"On-treatment virologic failure was defined as:
Viral breakthrough: HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or
Viral rebound: > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or
Nonresponse: HCV RNA persistently ≥ LLOQ through 8 weeks of treatment"|Up to 24 weeks|Full Analysis Set||percentage of participants|||Number
672920|NCT01667731|Secondary|Change From Baseline in HCV RNA at Week 8||Baseline; Week 8|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
672921|NCT01667731|Secondary|Change From Baseline in HCV RNA at Week 6||Baseline; Week 6|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
672922|NCT01667731|Secondary|Change From Baseline in HCV RNA at Week 4||Baseline; Week 4|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
685308|NCT01505374|Secondary|Tracking Total Opioid Usage||Up to postoperative day 2|||milligrams||Standard Deviation|Mean
672929|NCT01667679|Secondary|Number of Participants With the Indicated Physical Examination Abnormalities at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)|The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1. Clinical significance was determined by the Investigator (per clinical judgement). CS = clinically significant. CNS = clinically not significant.|Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)|Safety Analysis Set||participants|||Number
672930|NCT01667679|Secondary|Number of Participants With the Indicated 12-lead Electrocardiogram (ECG) Findings at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)|"The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1. Clinical significance was determined by the Investigator (per clinical judgement). A categorization of normal or abnormal was made per the investigators' clinical judgment of the ECG, taking the participants' demographic characteristics and other medical conditions into account. CS = clinically significant. CNS = clinically not significant."|Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)|Safety Analysis Set||participants|||Number
672931|NCT01667679|Secondary|Change From Baseline in Pulse at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)|Change from Baseline in pulse was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.|Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)|Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).||beats per minute||Standard Deviation|Mean
672932|NCT01667679|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)|Change from Baseline in SBP and DBP was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.|Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)|Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).||millimeters of mercury (mmHg)||Standard Deviation|Mean
672933|NCT01667679|Secondary|Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)|"The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1. Data are based on standard reads, with 1+, 2+, and 3+ indicating increasing amounts of metabolites in urine."|Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)|Safety Analysis Set||participants|||Number
672934|NCT01667679|Secondary|Change From Baseline in Urinalysis Values by Dipstick Method at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)|Change from Baseline in urinalysis values was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.|Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)|Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).||pH||Standard Deviation|Mean
672935|NCT01667679|Secondary|Change From Baseline in Sodium, Potassium, Chloride, Calcium, and Glucose at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)|Change from Baseline in sodium, potassium, chloride, calcium, and glucose was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.|Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)|Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).||mmoles/L||Standard Deviation|Mean
672936|NCT01667679|Secondary|Change From Baseline in Albumin and Total Protein at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)|Change from Baseline in albumin and total protein was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.|Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)|Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).||grams per Liter (grams/L)||Standard Deviation|Mean
672937|NCT01667679|Secondary|Change From Baseline in Total Bilirubin at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)|Change from Baseline in total bilirubin was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.|Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)|Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).||Units per Liter (U/L)||Standard Deviation|Mean
672938|NCT01667679|Secondary|Change From Baseline in Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)|Change from Baseline in AST and GGT was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.|Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)|Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).||International Units per Liter (IU/L)||Standard Deviation|Mean
672989|NCT01667107|Post-Hoc|Time to Maximum Serum Concentration of Posaconazole (Tmax)|Blood samples for measurement of serum posaconazole were collected approximately 4 hours after the first daily dose on Days 1-12 and every Monday and Thursday on Days 13-43. The time required to achieve the maximum serum concentration of posaconazole was recorded.|Four hours after the first daily dose on Days 1-12 and every Monday and Thursday on Days 13-43|The population analyzed included all enrolled participants||Days||Standard Deviation|Mean
672939|NCT01667679|Secondary|Change From Baseline in Alkaline Phosphatase (ALP) and Alanine Aminotransferase (ALT) at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)|Change from Baseline in ALP and ALT was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.|Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)|Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).||International Units per Liter (IU/L)||Standard Deviation|Mean
672940|NCT01667679|Secondary|Change From Baseline in Creatinine at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)|Change from Baseline in creatinine was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.|Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)|Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).||micromoles per Liter (µmol/L)||Standard Deviation|Mean
672941|NCT01667679|Secondary|Change From Baseline in Urea at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)|Change from Baseline in urea was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.|Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)|Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).||millimoles per Liter (mmol/L)||Standard Deviation|Mean
672942|NCT01667679|Secondary|Change From Baseline in White Blood Cell Count, Basinophils, Monocytes, Neutrophils, Lymphocytes, Eosinophils, and Platelets at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)|Change from Baseline in white blood cell (WBC) count, basinophils, monocytes, neutrophils, lymphocytes, eosinophils, and platelets was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.|Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)|Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).||10^9 cells per Liter||Standard Deviation|Mean
672943|NCT01667679|Secondary|Change From Baseline in Red Blood Cell Count at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)|Change from Baseline in red blood cell count was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.|Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)|Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).||10^12 cells per Liter||Standard Deviation|Mean
672944|NCT01667679|Secondary|Change From Baseline in Hematocrit at Visit 3 (up to 12 Weeks) and Visit 4 (up to 24 Weeks)|Change from Baseline in hematocrit (proportion of total blood volume that is composed of red blood cells) was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value.The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.|Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)|Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).||proportion||Standard Deviation|Mean
672945|NCT01667679|Secondary|Change From Baseline in Hemoglobin at Visit 3 (up to 12 Weeks) and Visit 4 (up to 24 Weeks)|Change from Baseline in hemoglobin was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.|Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)|Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).||grams per Liter (g/L)||Standard Deviation|Mean
672946|NCT01667679|Secondary|Number of Participants With Any Treatment-emergent Non-serious and Serious Adverse Event|An adverse event is defined as any untoward medical occurrence associated with the use of an investigational product in humans, whether or not it is considered related to the investigational product. This includes any occurrence that was new in onset or aggravated in severity or frequency from the Baseline condition.|Baseline compared to Vist 2, 3 and 4|Safety Analysis Set: all randomized participants who received at least 1 dose of either 20 mg sumatriptan nasal powder or 100 mg sumatriptan tablet||participants|||Number
672947|NCT01667679|Secondary|Mean Change From Baseline in Clinical Disability Score at 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose|Participants were required to record their clinical disability score in their e-diaries immediately before intake of study medication (Baseline) and at 10, 15, 30, 45, 60, 90, and 120 minutes post-dose. Participants graded their disability on the following scale: 0, no disability, able to function normally; 1, performance of daily activities mildly impaired, can still do everything but with difficulty; 2, performance of daily activities moderately impaired, unable to do some things; 3, performance of daily activities severely impaired, cannot do all or most things, bed rest may be necessary. Mean change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and 10, 15, 30, 45, 60, 90, and 120 minutes post-dose (up to 24 weeks)|FAS. The LOCF imputation method was used for this analysis. Results are from an ANCOVA model with treatment, period, and treatment sequence as fixed effects and participant as a random effect.||scores on a scale||Standard Error|Least Squares Mean
672990|NCT01667107|Post-Hoc|Maximum Serum Concentration of Posaconazole (Cmax)|Blood samples for measurement of serum posaconazole were collected approximately 4 hours after the first daily dose on Days 1-12 and every Monday and Thursday on Days 13-43. The maximum serum concentration of posaconazole was recorded.|Four hours after the first daily dose on Days 1-12 and every Monday and Thursday on Days 13-43|The population analyzed included all enrolled participants||mg/L||Standard Deviation|Mean
672948|NCT01667679|Secondary|Mean Change in Headache Severity From Baseline to 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose|Participants were required to record their headache severity score in their e-diaries immediately before intake of study medication (Baseline) and at 10, 15, 30, 45, 60, 90, and 120 minutes post-dose. Participants graded their headaches on the following severity scale: 0, none; 1, mild; 2, moderate; 3, severe. Mean change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and 10, 15, 30, 45, 60, 90, and 120 minutes post-dose (up to 24 weeks)|FAS. The LOCF imputation method was used for this analysis. Results are from an ANCOVA model with treatment, period, and treatment sequence as fixed effects and participant as a random effect.||scores on a scale||Standard Error|Least Squares Mean
672949|NCT01667679|Secondary|Median Time to Pain Freedom|Pain freedom is defined as a pain level reduced to none (Grade 0).|120 minutes post-dose (up to 24 weeks)|FAS. If the participant did not report pain freedom within 120 minutes post-dose, he/she was considered to be censored at the last non-missing result prior to the 120-minute time point.||minutes||95% Confidence Interval|Median
672950|NCT01667679|Secondary|Percentage of Attacks in Which Pain Relief Was Achieved|Percentage of attacks treated at a severity of moderate (Grade 2) or severe (Grade 3) in which pain relief (defined as pain level reduced to none [Grade 0] or mild [Grade 1]) was achieved at 10, 15, 30, 45, 60, 90, and 120 minutes after the initial dose for all attacks.|Baseline and 10, 15, 30, 45, 60, 90, and 120 minutes post-dose (up to 24 weeks)|FAS. The LOCF imputation method was used in this analysis.||percentage of attacks|number of moderate or severe attacks||Number
672951|NCT01667679|Secondary|Percentage of Attacks in Which Pain Freedom Was Achieved|Percentage of attacks in which pain freedom (defined as pain level reduced to none [Grade 0]) was achieved at 10, 15, 30, 45, 60, 90, and 120 minutes after the initial dose for all attacks.|Baseline and 10, 15, 30, 45, 60, 90, and 120 minutes post-dose (up to 24 weeks)|FAS. The LOCF imputation method was used for this analysis.||percentage of attacks|number of attacks||Number
672952|NCT01667679|Secondary|Percentage of Attacks in Which Pain Reduction Was Achieved|Percentage of attacks in which pain reduction (defined as a decrease in pain intensity of at least one point on the following scale: 0, none; 1, mild; 2, moderate; 3, severe) was achieved at 10, 15, 30, 45, 60, 90, and 120 minutes after the initial dose for all attacks.|10, 15, 30, 45, 60, 90, and 120 minutes|FAS. The LOCF imputation method was used in this analysis.||percentage of attacks|number of attacks||Number
672953|NCT01667679|Secondary|Mean Sum of Migraine Pain Intensity Differences (SPID)-30 for Headaches With a Baseline Intensity of Mild and Moderate/Severe|"SPID-30 is defined as the sum of the pain intensity differences (measured as area under the curve) from dosing (Baseline) through 30 minutes post-dose for headaches with a Baseline intensity of mild and moderate/severe (rated on a 4-point scale: 0=none, 1=mild, 2=moderate, and 3=severe). The range of possible scores for all participants is -60 to +90. For participants with a mild headache at Baseline, the SPID range is -60 to +30. For participants with a moderate/severe headache at Baseline, the SPID range is -30 to +90. A higher number indicates a greater reduction in pain intensity. Negative values indicate worsening pain. A value of 0 indicates that there was no change in pain intensity from Baseline through 30 minutes. Results are from an ANCOVA model with treatment, period, and treatment sequence as fixed effects and participant as a random effect. The LOCF imputation method (missing values were replaced by carrying forward the preceding value) was used for this analysis."|Baseline and 30 minutes post-dose (up to 24 weeks)|FAS. Only those participants with the type of attack specified were analyzed (specified by n=X, X in the corresponding category title). A single participant could have had both a mild and a moderate/severe attack.||scores on a scale||Standard Error|Least Squares Mean
672954|NCT01667679|Primary|Mean Sum of Migraine Pain Intensity Differences (SPID)-30|"SPID-30 is defined as the sum of the pain intensity differences (measured as area under the curve) from dosing (Baseline) through 30 minutes post-dose for headaches with a Baseline intensity of mild, moderate, or severe. The range of possible scores is -60 to +90. A higher number indicates a greater reduction in pain intensity. Negative values indicate worsening pain. A value of 0 indicates that there was no change in pain intensity from Baseline through 30 minutes. Results are from an analysis of covariance (ANCOVA) model with treatment, period, and treatment sequence as fixed effects and participant as a random effect. The Last Observation Carried Forward (LOCF) imputation method (missing values were replaced by carrying forward the preceding value) was used for this analysis."|Baseline and 30 minutes post-dose (up to 24 weeks)|Full Analysis Set (FAS): all participants who experienced at least 1 headache attack per treatment period, received at least 1 dose of study medication (sumatriptan nasal powder or tablet) in each treatment period, and had at least 1 post-Baseline assessment for a treated attack in each treatment period.||scores on a scale||Standard Error|Least Squares Mean
672955|NCT01667536|Secondary|Assess the Comparative Performance of MIP-1404 Against MRI for Detection of Metastatic Prostate Cancer Within Pelvic Lymph Nodes.|Comparative performance characteristics between MIP-1404 imaging and MRI were analyzed for the lymph nodes. MIP-1404 and MRI sensitivities were derived from case positive histopathology results.|Within 3-6 hours of dosing SPECT/CT images will be taken|All subjects who completed lymph node SPECT/CT MIP-1404 and MRI imaging, underwent EPLND, and had histopathology results.||% sensitivity|||Number
672956|NCT01667536|Secondary|Assess the Comparative Performance of MIP-1404 Against MRI for Detection of Prostate Cancer Within the Prostate Gland.|Comparative performance characteristics between MIP-1404 imaging and MRI were analyzed for the prostate gland. MIP-1404 and MRI sensitivities were derived from case positive histopathology results.|Within 3-6 hours of dosing SPECT/CT images will be taken|All subjects who completed prostate SPECT/CT MIP-1404 and MRI imaging and had histopathology results.||% specificity|||Number
672957|NCT01667536|Secondary|Assess the Ability of MIP-1404 to Detect the Specific Location of Metastatic Prostate Cancer Within Anatomic Pelvic Lymph Node Regions|"For specific segments of the lymph nodes, a sensitivity value refers to the number of evaluable segments (histologically examined tissue-segments) from all subjects, i.e., the percentages of true positive segments correctly identified by the imaging technique."|Within 3-6 hours of dosing SPECT/CT images will be taken|The primary analysis population is defined as all subjects who completed prostate and lymph node SPECT/CT MIP-1404 imaging, underwent EPLND, and had histopathology results. This population is one less than the safety population (n=105)||% sensitivity|Lymph Node Segments|90% Confidence Interval|Number
673031|NCT01665807|Secondary|Local & Systemic Reactogenicity|Maximum self-reported diameter of redness, induration, and swelling, and maximum intensity and duration of itchiness, fever, muscle ache, joint pain, headache, fatigue, feeling unwell, and injection site pain as reported on Day 8 after vaccination|Follow up (Day 8)||||||
672958|NCT01667536|Secondary|Assess the Ability of MIP-1404 to Detect the Extent and Location of Prostate Cancer Within the Prostate Gland|For specific segments of the prostate, a sensitivity value refers to the number of evaluable segments (histologically examined “tissue-segments”) from all subjects, i.e., the percentages of true positive segments correctly identified by the imaging technique.|Within 3-6 hours of dosing SPECT/CT images will be taken|The primary analysis population is defined as all subjects who completed prostate and lymph node SPECT/CT MIP-1404 imaging, underwent EPLND, and had histopathology results. This population is one less than the safety population (n=105)||% sensitivity|Prostate Segments|90% Confidence Interval|Number
672959|NCT01667536|Secondary|Assess the Ability of MIP-1404 to Detect Metastatic Prostate Cancer Within Pelvic Lymph Nodes|For lymph nodes, sensitivity values refer to the number of subjects in the study, i.e., the percentages of true positive subjects correctly identified by the imaging technique. Pathology results were used as the truth standard for all imaging analyses.|Within 3-6 hours of dosing SPECT/CT images will be taken|The primary analysis population, defined as all subjects who completed prostate and lymph node SPECT/CT MIP-1404 imaging, underwent EPLND, and had histopathology results, was used for this endpoint. A total of 3025 nodes were removed from 103 subjects (mean 29.6, range 1-88). Of these, 79 nodes were positive by pathology in 33 subjects.||% sensitivity||90% Confidence Interval|Number
672960|NCT01667536|Primary|Assess the Ability of 99mTc-MIP-1404 to Detect Prostate Cancer Within the Prostate Gland.|For the prostate gland, sensitivity values refer to the number of subjects in the study, i.e., the percentages of true positive subjects correctly identified by the imaging technique. Pathology results were used as the truth standard for all imaging analyses.|Within 3-6 hours of dosing SPECT/CT images will be taken|The primary analysis population is defined as all subjects who completed prostate and lymph node SPECT/CT MIP-1404 imaging, underwent EPLND, and had histopathology results. This population is one less than the safety population (n=105)||% sensitivity||90% Confidence Interval|Number
672961|NCT01667471|Secondary|CRP Levels|CRP an acute phase protein, is a marker of inflammation. CRP was measured as milligrams per deciliter (mg/dL).|Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76 and Final Follow-Up Follow-Up Visit (up to 82 weeks)|Safety Analysis Set; n = number of participants analyzed at the specified visit.||mg/dL||Standard Deviation|Mean
672962|NCT01667471|Secondary|Parent or Participant's Assessment of Pain (VAS)|Parents or participants rated participant's pain by placing a horizontal line on a VAS of 0 (no pain)- 100 mm (severe pain).|Baseline, Weeks 12, 24, 28, 32, 36, 48, 60, 72, and Final Follow-Up Visit (up to 82 weeks)|Safety Analysis Set; n = number of participants analyzed at the specified visit.||mm||Standard Deviation|Mean
672963|NCT01667471|Secondary|CHAQ-DI Score|The CHAQ-DI questionnaire consisted of 30 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities. Each domain had at least two component questions and if applicable to the participant there were four possible responses (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, 3 = unable to do). The CHAQ-DI score is the sum of the domain scores divided by the number of domains that have a non-missing score. This overall score ranges from 0 (best) to 3 (worst).|Baseline, Weeks 12, 24, 28, 32, 36, 48, 60, 72, and Final Follow-Up Visit (up to 82 weeks)|Safety Analysis Set; n = number of participants analyzed at the specified visit.||score on a scale||Standard Deviation|Mean
672964|NCT01667471|Secondary|Erythrocyte Sedimentation Rate|ESR is a marker of inflammation and was measured as millimeters per hour (mm/h). Healthy individuals have low ESR. Higher ESR indicate inflammation.|Baseline, Weeks 4, 8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76 and Final Follow-Up Visit (up to 82 weeks)|Safety Analysis Set; n = number of participants analyzed at the specified visit.||mm/h||Standard Deviation|Mean
672965|NCT01667471|Secondary|Number of Joints With Lack of Motion|Joints with lack of movement were assessed. The maximum number of joints with lack of movement was 67. The joint assessment was performed by an independent assessor who was not the treating physician and who was blinded to all other aspects of the participant’s efficacy and safety data.|Baseline, Weeks 12, 24, 28, 32, 36, 48, 60, 72 and Final Follow-Up Visit (up to 82 weeks)|Safety Analysis Set; n = number of participants analyzed at the specified visit.||joints||Standard Deviation|Mean
672966|NCT01667471|Secondary|Number of Joints With Active Arthritis|Joints with active arthritis were defined as joints with swelling or pain and limited of motion. The maximum number of joints with active arthritis was 71.The joint assessment was performed by an independent assessor who was not the treating physician and who was blinded to all other aspects of the participant’s efficacy and safety data.|Baseline, Weeks 12, 24, 28, 32, 36, 48, 60, 72 and Final Follow-Up Visit (up to 82 weeks)|Safety Analysis Set; n = number of participants analyzed at the specified visit.||joints||Standard Deviation|Mean
672967|NCT01667471|Secondary|Parent or Participant's Assessment of Global Activity (VAS)|The participant or parent/guardian, as appropriate, provided a rating of the participant’s well-being on a 0 to 100 mm horizontal scale. The extreme left end of the line Score 0 represented ‘very well’ (ie, symptom-free and no arthritis disease activity) and the extreme right end score 100 represented ‘very poor’ (ie, maximum arthritis disease activity). A higher score indicated poorer well-being.|Baseline, Weeks 12, 24, 28, 32, 36, 48, 60, 72 and Final Follow-Up Visit (up to 82 weeks)|Safety Analysis Set; n = number of participants analyzed at the specified visit.||mm||Standard Deviation|Mean
672968|NCT01667471|Secondary|Physicians Assessment of Global Activity (VAS)|The participant’s treating physician provided a rating of the participant’s arthritis disease activity on a 0 to 100 mm horizontal scale. The extreme left end of the line, score 0 represented ‘arthritis inactive’ (ie, symptom-free and no arthritis symptoms) and the extreme right end score 100 represented ‘arthritis very active’. A higher score indicated more disease activity.|Baseline, Weeks 12, 24, 28, 32, 36, 48, 60, 72 and Final Follow-Up Visit (up to 82 weeks)|Safety Analysis Set; n = number of participants analyzed at the specified visit.||mm||Standard Deviation|Mean
672969|NCT01667471|Secondary|Percentage of Participants Achieving Clinical Remission (CR) at Each Visit|"CR was defined as clinical remission with medication (CRem). A participant was in CR if inactive disease was observed for a minimum of 6 consecutive months."|Baseline, Screening, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76 and Final Follow-Up Visit (up to 82 weeks)|Safety Analysis Set; n = number of participants analyzed for the given parameter at the specified visit.||percentage of participants|||Number
685588|NCT01499810|Secondary|Change in Mean 24-h Diastolic BP||from baseline to 6 months|Number of participants assessed at 6 months minus 2 participants with unsatisfactory ABPM record||mmHg||Standard Deviation|Mean
672970|NCT01667471|Secondary|Percentage of Participants With Inactive Disease by Visit|A participant was defined to show inactive disease if all of the following criteria were applied: 1) No joints with active arthritis (no joints with swelling and no joints with lack of motion), 2) No fever, rash, serositis, splenomegaly, or generalized lymphadenopathy attributable to JIA, 3) No active uveitis, 4) ESR and/or CRP within normal range, and 5) Physician's global assessment of disease activity equals (=) 0 millimeters (mm) on a Visual analog scale (VAS).|Baseline, Weeks 12, 24, 36, 48, 60, 72 and Final Follow-Up Visit (up to 82 weeks)|Safety Analysis Set; n = number of participants analyzed for the given parameter at the specified visit.||percentage of participants|||Number
672971|NCT01667471|Primary|Number of AEs of Special Interest and Study Drug Related AEs|AEs and SAEs were recorded from the first day of tocilizumab administration until 4 weeks after administration of the last dose of tocilizumab.|Baseline and every 4 weeks up to Week 76 and Final Follow-Up Visit (up to 82 weeks)|Safety Analysis Set||adverse events|||Number
672972|NCT01667471|Secondary|Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30/50/70/90 by Visit|"The six JIA ACR components comprised of: 1) Physician's global assessment of disease activity, 2) Parent/Participant's global assessment of overall well-being, 3) Maximum number of joints with active arthritis, 4) Number of joints with limitation of movement, 5) Erythrocyte Sedimentation Rate (ESR) and/or C-reactive Protein (CRP), and 6) Childhood Health Assessment Questionnaire - Disease Index (CHAQ-DI).
At an assessment visit, a JIA ACR30/50/70/90 response in comparison to Baseline was defined as: At least three of the six JIA ACR core components improving by at least 30 percent (%), 50%, 70%, or 90% respectively and no more than one of the remaining JIA ACR core components worsening by more than 30%."|Baseline, Weeks 12, 24, 36, 48, 60, 72 and Final Follow-Up Visit (up to 82 weeks)|Safety Analysis Set; number (n) = number of participants analyzed for the given parameter at the specified visit.||percentage of participants|||Number
672973|NCT01667471|Primary|Number of Participants With Adverse Events of Special Interest and Study-Drug Related Adverse Events|Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first day of tocilizumab administration until 4 weeks after administration of the last dose of tocilizumab. AEs of special interest were Infections (including all opportunistic infections and non-serious infections as defined by those treated with IV anti-infectives), Myocardial infarction/Acute coronary syndrome, Gastrointestinal perforations and related events, Malignancies, Anaphylaxis/Hypersensitivity reactions, Demyelinating disorders, Stroke. Bleeding events, Hepatic events and Macrophage activation syndrome (MAS).|Baseline and every 4 weeks up to Week 76 and Final Follow-Up Visit (up to 82 weeks)|Safety Analysis Set||participants|||Number
672974|NCT01667432|Secondary|Safety: Incidence of Adverse Events||approximately 3 years||||||
672975|NCT01667432|Primary|In HBeAg Positive Patients: Percentage of Patients Who Become HBeAg Negative and Anti-HBe Positive||approximately 3 years||||||
672976|NCT01667432|Secondary|Incidence of Serum ALT Normalization: Serum ALT/ALT Ratio||approximately 3 years||||||
672977|NCT01667432|Secondary|Correlation of HBsAg Clearance With Pre-treatment Factors in HBeAg Positive and HBeAg Negative Patients||approximately 3 years||||||
672978|NCT01667432|Secondary|Correlation of HBsAg Clearance With Other On-treatment Factors in HBeAg Positive and HBeAg Negative Patients||approximately 3 years||||||
672979|NCT01667432|Secondary|HBsAg Clearance: Percentage of Patients Who Become HBsAg Negative||approximately 3 years||||||
672980|NCT01667432|Secondary|Percentage of Participants With Suppression of HBV DNA to < 80 IU/ml at the End of Treatment|Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) was assessed in plasma samples using quantitative polymerase chain reaction (PCR). Results are reported in international units (IU) per milliliter (ml) separately for participants who were hepatitis B envelope antigen (HBeAg) positive and HBeAg negative.|At the end of treatment (Week 24)|Intent-to-treat population: All participants who received at least 1 dose of peginterferon alfa-2a. Only participants with available HBsAg measurements were included in the analysis.||percentage of participants||95% Confidence Interval|Number
672981|NCT01667432|Primary|Percentage of Patients With Suppression of HBV DNA < 2,000 IU/ml||approximately 3 years||||||
672982|NCT01667432|Primary|Percentage of Participants With Suppression of HBV DNA to < 2,000 IU/ml at the End of the Study|Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) was assessed in plasma samples using quantitative polymerase chain reaction (PCR). Results are reported in international units (IU) per milliliter (ml).|At the end of the study (Week 36)|Intent-to-treat population: All participants who received at least 1 dose of peginterferon alfa-2a.||Percentage of participants||95% Confidence Interval|Number
672983|NCT01667224|Secondary|Changes in Body Mss Index(BMI)|BMI was measured in study visit 1 (0 week), visit 2 (4 week), visit 3 (8 week) and visit 4 (12 week).|study visit 1(0 week), visit 2(4 week), visit 3(8 week) and visit 4(12 week)|||kg/m^2||Standard Error|Mean
672984|NCT01667224|Secondary|Changes in Body Weight.|Body weight was measured in study visit 1(0 week), visit 2(4 week), visit 3(8 week) and visit 4(12 week).|study visit 1(0 week), visit 2(4 week), visit 3(8 week), and visit 4(12 week)|||kg||Standard Error|Mean
672985|NCT01667224|Secondary|Changes in Abdominal Total Fat Area.|Abdominal total fat area was measured in study visit 1(0 week) and visit 4(12 week).|study visit 1(0 week), visit 4(12 week)|||cm^2||Standard Error|Mean
672986|NCT01667224|Primary|Changes in Body Fat Mass.|Body fat mass was measured in study visit 1(0 week), visit 2(4 week), visit 3(8 week) and visit 4(12 week).|study visit 1(0 week), visit 2(4 week), visit 3(8 week) and visit 4(12 week)|||kg||Standard Error|Mean
672987|NCT01667107|Secondary|Percentage of Participants Who Develop Invasive Fungal Infection|Invasive fungal infection was assessed using the Mycoses Study Group/European Organisation for Research and Treatment of Cancer (MSG/EORTC) criteria. Infections counted in the analysis were those classified as 'proven', 'probable', or 'possible' according to the criteria.|Up to Day 84|Participants were analyzed according to the group in which they were enrolled||Percentage of participants||95% Confidence Interval|Number
672988|NCT01667107|Primary|Concentration of Posaconazole in Bronchoalveolar Lavage (BAL) and Serum|Concurrent BAL and serum samples for measurement of posaconazole concentration were to be collected during any clinically-indicated bronchoscopy. A participant could have more than 1 bronchoscopy.|Up to Day 42|The population analyzed included all enrolled participants who had BAL and serum samples collected at the time of bronchoscopy and analyzed for posaconazole concentration. A participant could have more than 1 pair of samples (BAL and serum) included in the analysis.||mg/L|paired BAL and serum samples|Standard Deviation|Mean
672991|NCT01667107|Post-Hoc|Time to Reach a Serum Concentration of Posaconazole of >=0.5 mg/L|Blood samples for measurement of serum posaconazole were collected approximately 4 hours after the first daily dose on Days 1-12 and every Monday and Thursday on Days 13-43. A posaconazole concentration >=0.5 mg/L is the therapeutic level, the concentration thought to lead to antifungal efficacy. The time at which the serum posaconazole concentration reached >=0.5 mg/mL and remained at that level for all subsequent assessments was recorded.|Four hours after the first daily dose on Days 1-12 and every Monday and Thursday on Days 13-43|The population analyzed included all enrolled participants who reached and maintained posaconazole concentration of >=0.5 mg/L||Days||Standard Deviation|Mean
672992|NCT01667107|Primary|Time to Reach 90% of the Steady State Serum Concentration of Posaconazole|Blood samples for measurement of serum posaconazole were collected approximately 4 hours after the first daily dose on Days 1-12 and every Monday and Thursday on Days 13-43. The time to reach 90% of the steady state serum posaconazole concentration was to be estimated from fitting a linear model to the concentration data over time. The data did not permit estimation of the endpoint from the modeling proposed in the protocol.|Four hours after the first daily dose on Days 1-12 and every Monday and Thursday on Days 13-43|The population to be analyzed included participants who complied with the protocol sufficiently to ensure that the results would exhibit the effects of treatment|||||
672993|NCT01666951|Other Pre-specified|Evaluation of the Short-term Efficacy of LCP-Tacro After the Start of Dosing.|The efficacy is measured by the number of treatment failures defined as all-cause mortality, Graft Failure, Biopsy Proven Acute Rejection (BPAR) and Lost to follow up.|30 days|||participants|||Number
672994|NCT01666951|Other Pre-specified|Ratio of Nighttime to Daytime Systolic Blood Pressure (SBP) on Day 28.|"At selected sites, a 24-hour measurement of blood pressure will be performed to assess the variability (ei, nighttime dipping) between the two Groups at Days 28."|28 days|18 patients participated in the 24-hour blood pressure assessment, 8 in the LCP-Tacro arm and 10 on the Prograf arm.||ratio||Standard Deviation|Mean
672995|NCT01666951|Other Pre-specified|Ratio of Nighttime to Daytime Systolic Blood Pressure (SBP) on Day 14.|"At selected sites, a 24-hour measurement of blood pressure will be performed to assess the variability (ei, nighttime dipping) between the two Groups at Days 14."|14 days|18 patients participated in the 24-hour blood pressure assessment, 8 in the LCP-Tacro arm and 10 on the Prograf arm.||ratio||Standard Deviation|Mean
672996|NCT01666951|Primary|Pharmacokinetics (Fluctuation) of LCP-Tacro Compared to Prograf After Kidney Transplantation|The pharmacokinetic parameter (Fluctuation) was evaluated on Day 28 in adult de novo kidney recipients.|28 days|The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.||Percentage of fluctuation||Standard Deviation|Mean
672997|NCT01666951|Primary|Pharmacokinetics (Fluctuation) of LCP-Tacro Compared to Prograf After Kidney Transplantation|The pharmacokinetic parameter (Fluctuation) was evaluated on Day 14 in adult de novo kidney recipients.|14 days|The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.||Percentage of fluctuation||Standard Deviation|Mean
672998|NCT01666951|Primary|Pharmacokinetics (Tmax) of LCP-Tacro Compared to Prograf After Kidney Transplantation|The pharmacokinetic parameter (Tmax) was evaluated on Day 28 in adult de novo kidney recipients.|28 days|The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.||hour||Standard Deviation|Mean
672999|NCT01666951|Primary|Pharmacokinetics (Tmax) of LCP-Tacro Compared to Prograf After Kidney Transplantation|The pharmacokinetic parameter (Tmax) was evaluated on Day 14 in adult de novo kidney recipients.|14 days|The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.||hour||Standard Deviation|Mean
673000|NCT01666951|Primary|Pharmacokinetics (Tmax) of LCP-Tacro Compared to Prograf After Kidney Transplantation|The pharmacokinetic parameter (Tmax) was evaluated on Day 1 in adult de novo kidney recipients.|1 days|The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.||hour||Standard Deviation|Mean
673001|NCT01666951|Primary|Pharmacokinetics (Cmax and C24) of LCP-Tacro Compared to Prograf After Kidney Transplantation|The pharmacokinetic parameter (Cmax and C24) was evaluated on Day 28 in adult de novo kidney recipients.|28 days|The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.||ng/mL||Standard Deviation|Mean
673002|NCT01666951|Primary|Pharmacokinetics (Cmax and C24) of LCP-Tacro Compared to Prograf After Kidney Transplantation|The pharmacokinetic parameter (Cmax and C24) was evaluated on Day 14 in adult de novo kidney recipients.|14 days|The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.||ng/mL||Standard Deviation|Mean
673003|NCT01666951|Primary|Pharmacokinetics (Cmax and C24) of LCP-Tacro Compared to Prograf After Kidney Transplantation|The pharmacokinetic parameter (Cmax and C24) was evaluated on Day 1 in adult de novo kidney recipients.|1 days|The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.||ng/mL||Standard Deviation|Mean
673004|NCT01666951|Primary|Pharmacokinetics (AUC) of LCP-Tacro Compared to Prograf After Kidney Transplantation|The pharmacokinetic parameter (AUC) was evaluated on Day 28 in adult de novo kidney recipients. Samples were collected from 0 to 24 hours post dose.|28 days|The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.||ng*hr/mL||Standard Deviation|Mean
673005|NCT01666951|Primary|Pharmacokinetics (AUC) of LCP-Tacro Compared to Prograf After Kidney Transplantation|The pharmacokinetic parameter (AUC) was evaluated on Day 14 in adult de novo kidney recipients. Samples were collected from 0 to 24 hours post dose.|14 days|The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.||ng*hr/mL||Standard Deviation|Mean
673006|NCT01666951|Primary|Pharmacokinetics (AUC) of LCP-Tacro Compared to Prograf After Kidney Transplantation|The pharmacokinetic parameter (AUC) was evaluated on Day 1 in adult de novo kidney recipients. Samples were collected from 0 to 24 hours post dose.|1 days|The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.||ng*hr/mL||Standard Deviation|Mean
673007|NCT01666951|Other Pre-specified|Daytime, Nighttime Overnight Systolic Blood Pressure (SBP) on Day 28.|"At selected sites, a 24-hour measurement of blood pressure will be performed to assess the variability (ei, nighttime dipping) between the two Groups at Day 28."|28 days|18 patients participated in the 24-hour blood pressure assessment, 8 in the LCP-Tacro arm and 10 on the Prograf arm.||mmHg||Standard Deviation|Mean
673008|NCT01666951|Other Pre-specified|Daytime, Nighttime and Overnight Systolic Blood Pressure (SBP) on Day 14.|"At selected sites, a 24-hour measurement of blood pressure will be performed to assess the variability (ei, nighttime dipping) between the two Groups at Days 14."|14 days|18 patients participated in the 24-hour blood pressure assessment, 8 in the LCP-Tacro arm and 10 on the Prograf arm.||mmHg||Standard Deviation|Mean
673009|NCT01666912|Secondary|Rapid Repeat Pregnancy|To assess rapid repeat pregnancies among the study population, ie, the number of participants who reported a repeat pregnancy within 12 months postpartum.|12 months|||participants||95% Confidence Interval|Number
673010|NCT01666912|Secondary|Satisfaction|"To assess satisfaction with the contraceptive implant inserted in the postpartum period, using a scale of 0-10, with 0 being not satisfied at all to 10 being extremely satisfied."|12 months|||units on a scale||Standard Deviation|Mean
673011|NCT01666912|Primary|Continuation at 1 Year|The number of participants using the contraceptive implant at one year postpartum among women who have the implant placed immediately postpartum vs. at 6 weeks postpartum.|12-14 months|||participants|||Number
673012|NCT01666782|Secondary|Evaluate and Compare the Local and Systemic Unsolicited Adverse Events to Both Vaccines.|Unsolicited adverse events occurring in more than one patient, standard-dose (SD) vaccine and high-dose (HD) vaccine|28 days|||participants|||Number
673013|NCT01666782|Secondary|Evaluate and Compare the Systemic Solicited Adverse Events to Both Vaccines.|Systemic solicited adverse events, standard-dose (SD) vaccine and high-dose (HD) vaccine|7 days|||participants|||Number
673014|NCT01666782|Secondary|Evaluate and Compare the Local Solicited Adverse Events to Both Vaccines.|Local solicited adverse events, standard-dose (SD) vaccine and high-dose (HD) vaccine|7 days|||participants|||Number
673015|NCT01666782|Secondary|The Seroconversion Rate of High-dose Influenza Vaccine Versus Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Less Than 65 Years Old.|Seroconversion rate was defined as the percentage of patients with a greater than or equal to 4-fold increase in HAI titer 28 days after vaccination.|Baseline and 28 days|||percentage of participants|||Number
673016|NCT01666782|Secondary|The Seroprotection Rate of High-dose Influenza Vaccine vs Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Less Than 65 Years Old.|Seroprotection rate was defined as the percentage of patients with a HAI GMT of at least 1:40 28 days after vaccination.|28 days|||percentage of participants|||Number
673017|NCT01666782|Primary|The Geometric Mean Titer (GMT) of High-dose Influenza Vaccine vs the Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Who Are Less Than 65 Years Old.|Measure Hemagglutination Inhibition (HAI) Geometric Mean Titer (GMT) immunogenicity of high-dose (HD) and standard dose (SD) vaccine before and after vaccination at day 28.|Baseline and 28 days|||titers||95% Confidence Interval|Geometric Mean
673018|NCT01666210|Other Pre-specified|Adverse Events|Measure of adverse events over the duration of each subject's participation in the study.|Duration of each individual subject's participation in the study|Ocular adverse events||percentage of participants|||Number
673019|NCT01666210|Primary|Absence of Pain in the Study Eye||Day 8|||Participants|||Count of Participants
673020|NCT01666210|Primary|Absence of Cells in Anterior Chamber of Study Eye||Day 8|||percentage of participants|||Number
673021|NCT01666197|Primary|Pain on Movement|"Change on a Visual analog scale from Baseline. Pain on Movement at 48 hours assessed on a 100 mm visual analog scale with anchors at 0=No pain and 100= Extreme pain"|48 hours|||mm||Standard Deviation|Mean
673022|NCT01666119|Primary|Adverse Events|Adverse events that occur in more than 2 subjects. Among the adverse events that occurred in > 2 subjects, the total number of unique events that were experienced are reported.|12 weeks|All subjects who received at least 1 dose of study drug.||adverse events|||Number
673023|NCT01666119|Secondary|Urine Drug Screen|Urine samples collected at screening and baseline to test for the presence of non-prescribed opioids.|12 weeks|Subjects with at least one urine drug screen test during the treatment period.||participants|||Number
673024|NCT01666002|Secondary|Proximal Clearance of Fungus on Nail|The secondary end point was proximal nail plate clearance as assessed directly by a single study physician, who measured the clinical involvement defined as total length of abnormal nail per each nail of each of the patients’ toenails, and confirmed by digital analysis of toenail photographs with ImageJ software.|1 year|||mm|Participants|Standard Deviation|Mean
673025|NCT01666002|Primary|The Primary End Point Was the Percentage of Patients With a Negative Mycological Culture.||1 year|||percentage of participants|||Number
673026|NCT01665950|Primary|Change in MADRS (4 Weeks)|Change in Montgomery-Asberg Depression Rating Scale (MADRS) in simvastatin-treated epochs versus placebo-treated epochs|Baseline vs week 4 (and, for placebo nonresponders in 1st 4 weeks, week 8 vs week 4)|||units on a scale|||Number
673027|NCT01665911|Secondary|Enamel Fluoride Uptake Per Each of Five Arms|Enamel fluoride uptake is a measure of fluoridation of a caries lesion|Three Weeks per each of five arms|||microgram fluoride per square cm||Standard Error|Least Squares Mean
673028|NCT01665911|Secondary|% Acid Resistance Score Per Each of Five Arms|% Acid Resistance is a measure of acid resistance of the remineralized caries lesion which is calculated as (D1-D2)/(D1-B)*100%, where B is the indentation length of sound enamel specimen at baseline, D1 is an indentation length after first in vitro demineralization, D2 is an indentation length after second in vitro demineralization.|Three Weeks per each of five arms|||percent||Standard Error|Least Squares Mean
673029|NCT01665911|Primary|% Surface Microhardness (SMH) Recovery Score Per Each of Five Arms|"surface microhardness recovery is a measure of caries lesion remineralization and is calculated using the following equation:
SMHr=(D1-R)/(D1-B)×100 B = indentation length of sound enamel specimen at baseline D1 = indentation length after first in vitro demineralization R = indentation length after intra-oral exposure (rehardening)."|Three Weeks per each of five arms|||percent||Standard Error|Least Squares Mean
673030|NCT01665807|Secondary|Pain at Injection Site|Self-perceived pain of injection will be recorded on an 11-point visual analogue scale immediately following vaccination (Day 0) and at follow-up (Day 8)|Follow up (Day 8||||||
673052|NCT01665508|Secondary|Peak O2 Pulse|peak O2 pulse as measured by cardiopulmonary exercise testing|3 months|||ml/beat||Standard Deviation|Mean
673053|NCT01665508|Secondary|Peak Heart Rate as Measured by Cardiopulmonary Exercise Testing|Assessment of peak heart rate as determined by CPET|3 months|||beats per minute||Standard Deviation|Mean
673054|NCT01665508|Secondary|Exercise Duration|Assessment of exercise duration as determined by CPET|3 months|||minutes||Standard Deviation|Mean
673055|NCT01665508|Secondary|SF36|The SF-36v2 is a commonly used instrument to assess HRQoL8. The questionnaire evaluates 8 HRQoL domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The physical component score is a composite of the SF-36v2 physical health domains (physical functioning, role-physical, bodily pain and general health) and the mental component score a composite of the mental health domains (vitality, social functioning, role-emotional and mental health). Each HRQoL domain score ranges from 0 to 100, with higher scores corresponding to a better health status. The SF-36v2 domain scores were calculated using the QualityMetric Health Outcomes Scoring Software version 4.5.|baseline and 12 week follow-up|physical functioning reported below||units on a scale||Standard Deviation|Mean
673056|NCT01665508|Secondary|Resource Utilization Questionnaire|Resource utilization as determined by patient phone calls, office visits, emergency room visits, and number of hospitalizations, as well an index cost for any hospitalizations|3 months|data was not collected|||||
673057|NCT01665508|Secondary|Peak VO2 Measured by Cardiopulmonary Exercise Testing|Assessment of exercise capacity (peak VO2) as determined by CPET|3 months|||ml/beat||Standard Deviation|Mean
673058|NCT01665508|Primary|Seattle Angina Questionnaire Score|"Seattle Angina Questionnaire (SAQ):
The SAQ is a 5 part survey that is widely used and well validated tool to assess angina stability and angina frequency among patients with coronary artery disease.
The SAQ is a validated, self-administered 19-item questionnaire with 5 different dimensions of health status in patients with CAD including: angina frequency, angina stability, disease-specific quality of life, physical limitations and treatment satisfaction. Each SAQ domain score ranges from 0-100, with higher scores indicating a better health status."|3 months|7 patients complete baseline and followup data reported below is anginal stability||units on a scale||Standard Deviation|Mean
673059|NCT01665170|Secondary|Sympathovagal Balance (After TSST, Sitting - 7. Measurement)|Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.|after TSST|||(low frequency/high frequency)*10||Standard Deviation|Mean
673060|NCT01665170|Secondary|Sympathovagal Balance (After TSST, Standing - 6. Measurement)|Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.|after TSST|||(low frequency/high frequency)*10||Standard Deviation|Mean
673061|NCT01665170|Secondary|Sympathovagal Balance (During TSST, Arithmetics - 5. Measurement)|Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.|during TSST|||(low frequency/high frequency)*10||Standard Deviation|Mean
673062|NCT01665170|Secondary|Sympathovagal Balance (During TSST, Interview - 4. Measurement)|Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.|during TSST|||(low frequency/high frequency)*10||Standard Deviation|Mean
673063|NCT01665170|Secondary|Sympathovagal Balance (During TSST, Preparation - 3. Measurement)|Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.|during TSST|||(low frequency/high frequency)*10||Standard Deviation|Mean
673064|NCT01665170|Secondary|Sympathovagal Balance (Before TSST, Standing - 2. Measurement)|Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.|before TSST|||(low frequency/high frequency)*10||Standard Deviation|Mean
673065|NCT01665170|Secondary|Sympathovagal Balance (Before TSST, Sitting - 1. Measurement)|Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.|before TSST|||(low frequency/high frequency)*10||Standard Deviation|Mean
673066|NCT01665170|Secondary|Norepinephrine (After)|2 min. after the TSST, higher value is better|1 day|||ng/dl||Standard Deviation|Mean
673147|NCT01664494|Secondary|Median Dose of Capecitabine|Median dose of capecitabine for treatment of metastatic colorectal cancer, adjuvant colon cancer, advanced gastric cancer, or metastatic breast cancer in this study was presented.|Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first|All enrolled participants were considered for this outcome measure.||Milligrams||Full Range|Median
673067|NCT01665170|Secondary|LSEQ Questionnaire (Behavior Following Awakening- Less Clumsy Balance and Coordination Upon Getting-up] Changes From V2 to V3|"The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.
The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; a higher value is a better outcome."|Visite 2 (before treatment), Visite 3 (after treatment)|||Percent Change||Standard Deviation|Mean
673068|NCT01665170|Secondary|LSEQ Questionnaire (Behavior Following Awakening- Feeling Alert Now] Changes From V2 to V3|"The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3.
V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.
The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome."|Visite 2 (before treatment), Visite 3 (after treatment)|||Percent Change||Standard Deviation|Mean
673069|NCT01665170|Secondary|LSEQ Questionnaire (Behavior Following Awakening- Feeling Alert Upon Awakening] Changes From V2 to V3|"The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.
The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome."|Visite 2 (before treatment), Visite 3 (after treatment)|||Percent Change||Standard Deviation|Mean
673070|NCT01665170|Secondary|LSEQ Questionnaire (Awakening From Sleep- Quicker Than Usual] Changes From V2 to V3|"The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.
The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome."|Visite 2 (before treatment), Visite 3 (after treatment)|||Percent Change||Standard Deviation|Mean
673071|NCT01665170|Secondary|LSEQ Questionnaire (Awakening From Sleep- Easier Than Usual] Changes From V2 to V3|"The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.
The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome."|Visite 2 (before treatment), Visite 3 (after treatment)|||Percent Change||Standard Deviation|Mean
673072|NCT01665170|Secondary|LSEQ Questionnaire (Quality of Sleep - Fewer Periods of Wakefulness Than Usual] Changes From V2 to V3|"The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.
The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome."|Visite 2, visite 3|||Percent Change||Standard Deviation|Mean
673085|NCT01665170|Primary|VAS Anxiety (During)|The primary objective is to assess effects of P. incarnata on psychological stress measured by Visual Analogue Scales (VAS; Bond and Lader 1974) by comparing scores collected before, during and after stress exposure between the P. incarnata and a placebo group. In this study, psychological stress is defined as stress perception, anxiety and insecurity. These three variables are determined simultaneously in the study before, during and after the stress test. Minimum = 0 mm; Maximum = 100 mm, higher value = represent a worsend outcome.|during stress test = Visite 3|||mm||Standard Deviation|Mean
673258|NCT01664104|Secondary|Swollen Joint Count (SJC) at Baseline|SJC was determined by examining 28 joints and identifying when swelling was present. Swelling was recorded on the joint assessment form at baseline; no swelling = 0 and swelling = 1.|Baseline|All enrolled participants evaluable for primary objective with available data for this outcome measure.||swollen joints||Standard Deviation|Mean
673073|NCT01665170|Secondary|LSEQ Questionnaire (Quality of Sleep - More Restful Than Usual] - Changes From V2 to V3|"The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.
The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome."|Visite 2 (before treatment), Visite 3 (after treatment)|||Percent Change||Standard Deviation|Mean
673074|NCT01665170|Secondary|LSEQ Questionnaire (Getting to Sleep-Feeling More Drowsy Than Usual] - Changes From V2 to V3|"The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.
The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; lower values represent a better outcome."|Visite 2 (before treatment), Visite 3 (after treatment)|||Percent Change||Standard Deviation|Mean
673075|NCT01665170|Secondary|LSEQ Questionnaire (Getting to Sleep-Falling Asleep More Quickly Than Usual] - Changes From V2 to V3|"The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.
The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome."|Visite 2 (before treatment), Visite 3 (after treatment)|||Percent Change||Standard Deviation|Mean
673076|NCT01665170|Primary|VAS Stress Perception (During)|The primary objective is to assess effects of P. incarnata on psychological stress measured by Visual Analogue Scales (VAS; Bond and Lader 1974) by comparing scores collected before, during and after stress exposure between the P. incarnata and a placebo group. In this study, psychological stress is defined as stress perception, anxiety and insecurity. These three variables are determined simultaneously in the study before, during and after the stress test. Minimum = 0 mm; Maximum = 100 mm, higher value = represent a worsend outcome.|during stress test = Visite 3|||mm||Standard Deviation|Mean
673077|NCT01665170|Secondary|LSEQ Questionnaire (Getting to Sleep-Falling Asleep Easier Than Usual) - Changes From V2 to V3|"The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3.
V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded. The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome."|Visite 2 (before treatment), Visite 3 (after treatment)|||Percent Change||Standard Deviation|Mean
673078|NCT01665170|Secondary|MDBF Questionnaire|"The MDBF assesses the three bipolar dimensions good/bad mood, wakefulness/tiredness and calmness/agitation (3 scales). The short form of the MDBF and its parallel version (versions A and B) each consist of 12 items. Subjects rate their mood state on a 5-point rating scale ranging from 1 = not at all to 5 = very true. To determine mood changes induced by the TSST, the questionnaire is completed shortly before (version A) and immediately after the TSST (version B). Assess before and after V3"|1 day||||||
673079|NCT01665170|Secondary|POMS Questionnaire|"The POMS assesses the four states depression/anxiety, fatigue, vigor and hostility (4 scales). High vigor scores reflect a positive mood whereas high scores in the other subscales indicate negative mood. Subjects rate their mood state on a 7-point rating scale ranging from 1 = not at all to 7 = very strongly. The questionnaire is completed on V2 and V3."|1 day||||||
673080|NCT01665170|Secondary|State Anxiety (STAI-X1) Questionnaire|"The STAI-X1 measures state anxiety (one scale). Answers are given on a four-point rating scale ranging from 1 = not at all to 4 = very true. The questionnaire is used as baseline measurement at V2. In addition, it is also employed before and immediately after the stress test at V3 to assess changes in state anxiety. Assess V2, before and after V3"|1 day||||||
673081|NCT01665170|Secondary|Norepinephrine (Before)|2 min. prior the TSST|before stress test|||ng/dl||Standard Deviation|Mean
673082|NCT01665170|Secondary|Epinephrine (Before)|2 min. prior the TSST|1 day||||||
673083|NCT01665170|Secondary|ACTH (Pre-post Comparison)|ACTH - Adrenocorticotropes Hormon - 2 min. prior to and 1 min. after the TSST|1 day||||||
673084|NCT01665170|Secondary|Serum Cortisol (Pre-post Comparison)|2 min. prior to and 1 min. after the TSST|1 day||||||
673110|NCT01665053|Primary|Percentage of Participants With Target Lesion Failure (TLF) at 12 Months|TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death.|12 months|The per protocol population was used for this analysis. Therefore the number of participants analyzed is not consistent with the numbers provided in participant flow module.||percentage of participants|||Number
673111|NCT01664975|Secondary|Median Survival Time||24 months||12/2016||||
673086|NCT01665170|Primary|VAS Insecurity (During)|The primary objective is to assess effects of P. incarnata on psychological stress measured by Visual Analogue Scales (VAS; Bond and Lader 1974) by comparing scores collected before, during and after stress exposure between the P. incarnata and a placebo group. In this study, psychological stress is defined as stress perception, anxiety and insecurity. These three variables are determined simultaneously in the study before, during and after the stress test. Minimum = 0 mm; Maximum = 100 mm, higher value = represent a worsend outcome.|during stress test = Visite 3|||mm||Standard Deviation|Mean
673087|NCT01665157|Primary|Segmental Cleansing Level at Colonoscopy (Right Segment Preparation Failure)|"Segmental score of Ottawa bowel preparation scale was analyzed. The proportion of right segment preparation failure, defined as segmental score as 3 poor or 4 inadequate, was presented."|1 day|||percentage of participants|||Number
673088|NCT01665157|Secondary|Convenience of Different Low Residual Diet and Bowel Preparation Protocol|It represented the percentage of participants who thinks the protocol is easy to use.|1 day|||percentage of participants|||Number
673089|NCT01665157|Secondary|Satisfaction of Different Low Residual Diet and Bowel Preparation Protocol|It represented the percentage of participants who is satisfied with the protocol.|1 day|||Percentage of participants|||Number
673090|NCT01665157|Primary|Total Volume of Purgatives That Ingested|The total volume of PEG-ELS (Liter) that ingested or could be ingested by examinee before colonoscopy|1 day|||Liter||Standard Deviation|Mean
673091|NCT01665157|Secondary|Willingness to Choose the Same Protocol After Different Low Residual Diet and PEG-ELS Protocol|It represent the proportion of participants who wanted to choose the same protocol as they received in this trial.|1 day|||percentage of participants|||Number
673092|NCT01665157|Primary|Overall Cleansing Level at Colonoscopy by Aronchick Scale|"The overall proportion of participants scored as Excellent or Good by Aronchick scale.
Description of Aronchick scale:It categorized colon cleansing into 5 level: Excellent, good, fair, poor, inadequate. It is categorical and cannot be summed. We will present"|1 day|||percentage of participants|||Number
673093|NCT01665157|Primary|Overall Cleansing Level at Colonoscopy by Ottawa Bowel Preparation Scale|Ottawa preparation scale: Colon is defined into 3 segments: Right(cecum, ascending), mid(transverse, descending), rectosigmoid. Each is scored from 0 to 4, 0 is best and 4 is worst. Fluid quantity of whole is scored as 0, small; 1, moderate; 2 large amount. The scale will be summation of the clearness of 3 segments of colon and overall fluid quantity. It ranged from 0 to 14, 0 is the most clean colon and 14 is the most dirty one. Segment score will be analyzed separately as continuous variable.|1 day|||units on a scale||Standard Deviation|Mean
673094|NCT01665053|Secondary|Percentage of Patients With Revascularization (=All Revascularizations) at 12 Month.|All CEC adjudicated revascularization at 12 month (Intent to treat population).|12 Month|Intent to treat population||percentage of patients|||Number
673095|NCT01665053|Secondary|Percentage of Participants With a Target Lesion Failure (TLF) at 12 Month.||12 month|Intent-to-Treat population||percentage of participants|||Number
673096|NCT01665053|Secondary|Periprocedural Clinical Procedural Success Rate|Procedural Success Rate is defined as post-procedure diameter less then 30% in 2 near-orthogonal projections with TIMI 3 flow in all target lesions without occurrence of in-hospital cardiac death, MI, TVR. Procedural success rate is subject based.|Day 1 (periprocedure)|Intent-to-Treat population||percentage of subjects|||Number
673097|NCT01665053|Secondary|Periprocedural Technical Success Rate.|Technical Success Rate is defined as successful delivery and deployment of the study stent to the target vessel, without balloon rupture or stent embolization, and post-procedure diameter stenosis less then 30% in 2 near-orthogonal projections with TIMI 3 flow in the target lesion. Technical success is lesion based.|Day 1 (periprocedure)|"Intent-to-Treat analysis set. Promus Element Plus population: 838 subject analyzed with 1043 lesions treated with technical success achieved in 1011 lesions.
SYNERGY population: 846 subjects analyzed with 1059 lesions treated with technical success achieved in 1041 lesions."||percentage of lesions|||Number
673098|NCT01665053|Secondary|Percentage of Patients With a Stroke at 12 Month.|The stroke rate includes: Ischemic- , Hemorraghic- & Undetermined Stroke.|12 months|Intent-to-Treat population.||percentage of participants|||Number
673099|NCT01665053|Secondary|Percentage of Participants With a ARC (Academic Research Consortium) Stent Thrombosis Rate at 12 Month.||12 months|Intent-to-treat population.||percentage of participants|||Number
673100|NCT01665053|Secondary|Percentage of Participants Who Died, Had an Myocardial Infarction (MI) or a Target Vessel Revascularization (TVR) at12 Month.||12 months|Intent-to-treat population||percentage of participants|||Number
673101|NCT01665053|Secondary|Percentage of Participants Who Died or Had an Myocardial Infarction (MI) at 12 Month.||12 months|Intent-to-treat population||percentage of participants|||Number
673102|NCT01665053|Secondary|Percentage of Patients With Cardiac Death or Myocardial Infarction (MI) at 12 Month.||12 months|Intent-to-treat population||percentage of participants|||Number
673103|NCT01665053|Secondary|Percentage of Patients That Died at 12 Months.|The Death rate includes Cardiac- & Non-Cardiac Death.|12 months|Intent-to-treat population||percentage of participants|||Number
673104|NCT01665053|Secondary|Percentage of Participants With Non-Cardiac Death at 12 Month.||12 months|Intent-to-treat population||percentage of participants|||Number
673105|NCT01665053|Secondary|Percentage of Participants With Cardiac Death at 12 Month.||12 months|Intent-to-treat population||percentage of participants|||Number
673106|NCT01665053|Secondary|Percentage of Participants With Myocardial Infarction at 12 Month.|The MI rate includes: MI's related to the Target Vessel, MI's with unknown relationship to the Target Vessel and MI's not related to the Target Vessel.|12 months|Intent-to-treat||percentage of participants|||Number
673107|NCT01665053|Secondary|Percentage of Participants With Target Vessel Failure (TVF) at 12 Month.|Target Vessel Failure is defined as any ischemic-driven revascularization of the target vessel, MI related to the target vessel, or any cardiac death.|12 months|Intent-to-treat analysis||percentage of participants|||Number
673108|NCT01665053|Secondary|Percentage of Participants With Target Vessel Revascularization (TVR) at 12 Months.|TVR overall includes: TVR PCI & TVR CABG.|12 months|Intent-to- Treat||percentage of participants|||Number
673109|NCT01665053|Secondary|Percentage of Participants With Target Lesion Revascularization (TLR) at 12 Months.|The TLR overall rate includes: TLR Percutaneous Coronary Intervention (PCI) & TLR Coronary Artery Bypass Graft (CABG).|12 months|Intent-to-Treat population||percentage of participants|||Number
673115|NCT01664949|Secondary|Change From Baseline in the Schirmer Test|The Schirmer's Test measures the rate of the secretion of tears produced by the eye over 5 minutes. The results indicate the presence of dry eye. The eye with the lower value at Baseline was used for Analysis. Normal = greater than or equal to 15 millimeters (mm) of tears, Dry Eye = less than 15 mm of tears.. The smaller the number, the more severe the dry eye. A positive number change from Baseline indicates improvement.|Baseline, Day 90|Participants from the Per-protocol population, all randomized participants without any significant protocol violations, with data available for analysis.||mm/5 minutes||Standard Deviation|Mean
673116|NCT01664949|Secondary|Change From Baseline in Conjunctival Staining|Staining of the conjunctiva following ocular administration of lissamine green dye was graded using a 6-point scale (0=no staining, 5=diffuse staining). Conjunctival staining has 2 zones, nasal and temporal, which are added together to provide the total staining score. The eye with the higher score at Baseline was used for analysis. The higher the grade score, the worse the dry eye severity. A negative number change from Baseline indicates improvement.|Baseline, Day 90|Participants from the Per-protocol population, all randomized participants without any significant protocol violations, with data available for analysis.||score on a scale||Standard Deviation|Mean
673117|NCT01664949|Secondary|Change From Baseline in Corneal Staining|Staining of the cornea following ocular administration of fluorescein dye was graded using a 6-point scale (0=no staining, 5=diffuse staining). The eye with the higher score at Baseline was used for analysis. The higher the grade score, the worse the dry eye severity. A negative number change from Baseline indicates improvement.|Baseline, Day 90|Participants from the Per-protocol population, all randomized participants without any significant protocol violations, with data available for analysis.||score on a scale||Standard Deviation|Mean
673118|NCT01664949|Secondary|Change From Baseline in Tear Break-up Time (TBUT)|TBUT is the time in seconds for the tear film to visually break up after a complete blink. The average of 3 consecutive observations is reported for each participant. The longer it takes, the more stable the tear film. The eye with the shorter average TBUT at Baseline was used for analysis. A positive number change from Baseline indicates improvement.|Baseline, Day 90|Participants from the Per-protocol population, all randomized participants without any significant protocol violations, with data available for analysis.||seconds||Standard Deviation|Mean
673119|NCT01664949|Primary|Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Day 90|The OSDI consists of 12 questions to assess visual function, ocular symptoms and environmental triggers related to dry eye. Each of the 12 questions is assessed using a 5-point scale (0=none of the time; 4 = all of the time) which is converted to a total score between 0-100. OSDI total scores of 0-12=normal (best), 13-22= mild ocular surface disease, 23-32 =moderate ocular surface disease, and 33-100=severe ocular surface disease (worst). A negative number change from Baseline indicates improvement.|Baseline, Day 90|Participants from the Per-protocol population, all randomized participants without any significant protocol violations, with data available for analysis.||score on a scale||Standard Deviation|Mean
673120|NCT01664923|Secondary|Percentage of Participants With Adverse Event (AE)|"Assessment of adverse events was conducted from the date and time of the first dose of study drug through 30 days after the date of the last dose of study drug or before initiation of a cytotoxic or investigational therapy, whichever occurred first.
A serious adverse event was defined as any untoward medical occurrence that:
Resulted in death;
Was life threatening;
Required inpatient hospitalization or led to prolongation of hospitalization;
Resulted in persistent or significant disability or incapacity;
Resulted in a congenital anomaly or birth defect;
Was a medically important event.
An adverse event was considered related to the study drug if the event was assessed by the investigator as probably or possibly related."|From first dose of study drug up to 30 days after last dose of study drug. Median duration of the AE reporting period was 15.2 months in the enzalutamide arm and 9.4 months in the bicalutamide arm.|Safety population: All participants randomly assigned to study treatment who received at least 1 dose of study drug.||percentage of participants|||Number
673121|NCT01664923|Secondary|Best Overall Soft Tissue Response|Best overall soft tissue response is defined as partial response (PR) or complete response (CR) while on study treatment based on investigator assessment of target, nontarget, and new lesions using RECIST 1.1. Only participants in the metastatic population with measurable soft tissue disease (at least 1 target lesion identified per RECIST 1.1) at screening were included in the analysis. All percentages are based on number of participants with metastatic and measurable soft tissue disease at screening in each treatment group.|From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm.|All participants who were randomly assigned to study treatment and had metastatic and measurable soft tissue disease at screening.||percentage of participants||95% Confidence Interval|Number
673122|NCT01664923|Secondary|Quality of Life: Time to Degradation of Functional Assessment of Cancer Therapy - Prostate (FACT-P)|"The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess patient function in 4 domains: physical, social/family, emotional, and functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain, as well as a global quality of life score (0 to 156) with higher scores representing better quality of life.
Time to degradation of FACT-P was defined as the time from randomization to first assessment with at least a 10-point decrease from baseline in the global FACT-P score for each participant. Participants with no score degradation at the time of analysis data cutoff were censored at the date of last assessment showing no degradation."|From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm.|Intent-to-treat population: all participants randomly assigned to study treatment.||months||95% Confidence Interval|Median
673134|NCT01664624|Secondary|Change From Baseline in Postprandial AUC(0-8) of C-peptide|The concentration of C-peptide in blood before and up to 8 hours after eating (postprandial) was plotted and the area under the curve calculated using the linear trapezoidal rule at Baseline and on Day 11. Least squares means of the change from Baseline to Day 11 were obtained using an ANCOVA model with treatment as fixed effect, and Baseline postprandial AUC (0-8) of C-peptide as a continuous covariate.|Baseline and Day 11; samples were taken at -15 min and -5 min (pre-meal), and 15 min, 30 min, and 1, 2, 3, 4, 6, and 8 hours (post-meal).|Full analysis set. Only participants with data at both Baseline and post-baseline visits are included.||ng/mL*hr||Standard Error|Least Squares Mean
673123|NCT01664923|Secondary|Duration of Radiographic PFS|Duration of radiographic PFS was defined as the time from randomization to the earliest objective evidence of radiographic disease progression or death on study and was to be evaluated for participants with metastatic disease at study entry. Radiographic disease progression in bone was based on PCWG2 guidelines defined as at least 2 new lesions on bone scan. Radiographic disease progression in soft tissue on CT/MRI was based on RECIST 1.1. CT/MRI and bone scans were read locally by the same radiologist (or nuclear medicine physician for interpretation of bone scans) whenever possible. Participants not known to have had radiographic progression at the time of analysis data cutoff were censored at the date of last radiographic assessment.|From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm.|All participants with metastatic disease at study entry and randomly assigned to study treatment.||months||95% Confidence Interval|Median
673124|NCT01664923|Secondary|Percentage of Participants With a PSA Response ≥ 50%|PSA response was defined as a reduction in PSA of at least 50% from baseline at any postbaseline assessment confirmed by a second PSA assessment at least 3 weeks later.|From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm.|Evaluable intent-to-treat population: all participants randomly assigned to study treatment and had a baseline and at least 1 postbaseline PSA measurement.||percentage of participants||95% Confidence Interval|Number
673125|NCT01664923|Secondary|Time to PSA Progression|PSA progression was defined as ≥ 25% increase in PSA with an absolute increase ≥ 2 ng/mL above the nadir and was to be confirmed by a second consecutive assessment at least 3 weeks later. Participants not known to have had PSA progression were censored at the date of last PSA assessment.|From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm.|Intent-to-treat population: all participants randomly assigned to study treatment.||months||95% Confidence Interval|Median
673126|NCT01664923|Primary|Progression Free Survival (PFS)|PFS was defined as time from randomization to earliest objective evidence of prostate specific-antigen (PSA) progression, radiographic progression, or death on study. PSA progression was defined as ≥ 25% increase in PSA with an absolute increase ≥ 2 ng/mL above the nadir and was to be confirmed by a second consecutive assessment. Radiographic progression in bone was based on The Prostate Cancer Clinical Trials Working Group (PCWG2) guidelines defined as at least 2 new lesions on bone scan. Radiographic progression in soft tissue on Computerized Tomography/Magnetic Resonance Imaging (CT/MRI) was based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). CT/MRI and bone scans were read locally by the same radiologist (or nuclear medicine physician for interpretation of bone scans) whenever possible. Participants not known to have had a PFS event at the time of the analysis data cutoff were censored at the date of last assessment.|From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm.|Intent-to-treat population: all participants randomly assigned to study treatment.||months||95% Confidence Interval|Median
673127|NCT01664806|Secondary|Histologic Evidence of Burn at the Umbilical Port Site Skin|Shave biopsy of skin at the umbilical port site after elective laparoscopic cholecystectomy will be performed. The secondary outcome is histologic evidence of burn at this port site.|1 day|A sample size of convenience for feasibility.||participants|||Number
673128|NCT01664806|Primary|Histologic Thermal Injury to Epigastric Port Site Skin|Shave biopsy of skin at the epigastric port site after elective laparoscopic cholecystectomy will be performed. The primary outcome is histologic evidence of burn at this port sites.|1 day|A sample size of convenience for feasibility.||participants|||Number
673129|NCT01664793|Secondary|Effectiveness Score|Two staff members from each site were surveyed as to usefulness/effectiveness of a list of strategies recommended in the toolkit to increase vaccination rates. Values (range = 1-100 with 1 being not at all effective and 100 being highly effective) were averaged and used as an effectiveness score for each strategy. The average value for each site was combined with all sites and averaged for each strategy. (actual range = 20.6-90.7).|End of February 2012|||units on a scale||Standard Deviation|Mean
673130|NCT01664793|Primary|Primary Outcome|Influenza vaccination rates in each arm at the end of year 1|3/1/2011-2/29/2012|||participants vaccinated out of all|||Number
673131|NCT01664624|Secondary|Change From Baseline to Day 11 in 24-hour Average Plasma Glucose|Plasma glucose was measured by Continuous Glucose Monitoring System (CGMS). CGMS measures glucose every 5 minutes, starting in the fasting state 8 hour prior to the standardized breakfast (12 AM) until 16 hours after the breakfast. The average 24-hour plasma glucose concentration was calculated. Least squares means were obtained using an ANCOVA model with treatment as fixed effect, and Baseline 24-hour Glucose Measured by CGMS as a continuous covariate.|Baseline (Day -1) and Day 11, from 12 AM through 24 hours.|Full analysis set. Only participants with data at both Baseline and post-baseline visits are included.||mg/dL||Standard Error|Least Squares Mean
673132|NCT01664624|Secondary|Change From Baseline to Day 11 in AUC(0-8) of Appetite Sensation|"Appetite sensations were measured using a visual analog scale (VAS) questionnaire. Participants were asked to indicate their level of fullness, hunger, satiety, and prospective consumption (how much do you think you can eat?) on a 100 mm line ranging from Not at all (0 mm) to extremely (100 mm). Appetite sensation scores before and up to 8 hours after eating were plotted and the area under the curve calculated using the linear trapezoidal rule at Baseline and on Day 11. Least squares means of the change from Baseline to Day 11 were obtained using an ANCOVA model with treatment as fixed effect, and Baseline postprandial AUC (0-8) of appetite sensation VAS score as a continuous covariate."|At Baseline and Day 11, every 30 minutes, starting 1 hour before eating until 8 hour after the meal.|Full analysis set. Only participants with data at both Baseline and post-baseline visits are included.||mm*hr||Standard Error|Least Squares Mean
673133|NCT01664624|Secondary|Change From Baseline in Postprandial AUC(0-8) of Insulin|The concentration of insulin in blood before and up to 8 hours after eating was plotted and the area under the curve calculated using the linear trapezoidal rule at Baseline and on Day 11. Least squares means of the change from Baseline to Day 11 were obtained using an ANCOVA model with treatment as fixed effect, and Baseline postprandial AUC (0-8) of insulin as a continuous covariate.|Baseline and Day 11; samples were taken at -15 min and -5 min (pre-meal), and 15 min, 30 min, and 1, 2, 3, 4, 6, and 8 hours (post-meal).|Full analysis set. Only participants with data at both Baseline and post-baseline visits are included.||pmol/L*hr||Standard Error|Least Squares Mean
673135|NCT01664624|Secondary|Change From Baseline in AUC(0-8) of Postprandial Plasma Glucose|The concentration of glucose in blood before and up to 8 hours after eating (postprandial) was plotted and the area under the curve calculated using the linear trapezoidal rule at Baseline and on Day 11. Least squares means of the change from Baseline to Day 11 were obtained using an ANCOVA model with treatment as fixed effect, and baseline postprandial AUC (0-8) of plasma glucose as a continuous covariate.|Baseline and Day 11 at -15 min and -5 min (pre-meal), and 15 min, 30 min, and 1, 2, 3, 4, 6, and 8 hours (post-meal).|Full analysis set. Only participants with data at both Baseline and post-baseline visits are included.||mmol/L*hr||Standard Error|Least Squares Mean
673136|NCT01664624|Primary|Change From Baseline in Postprandial Area Under the Curve From Time 0 to 8 Hours (AUC[0-8]) for Active Glucagon-like Peptide-1|The concentration of glucagon-like peptide-1 (GLP-1) in blood before and up to 8 hours after eating (postprandial) was plotted and the area under the curve calculated using the linear trapezoidal rule at Baseline and on Day 11. Least squares means of the change from Baseline to Day 11 were obtained using an analysis of covariance (ANCOVA) model with treatment as fixed effect, and Baseline postprandial AUC (0-8) of active GLP-1 as a continuous covariate.|Baseline and Day 11; samples were taken at -15 min and -5 min (pre-meal), and 15 min, 30 min, and 1, 2, 3, 4, 6, and 8 hours (post-meal).|Full analysis set defined as all randomized participants included in the safety analysis. Only participants with data at both Baseline and post-baseline visits are included.||pmol/L*hr||Standard Error|Least Squares Mean
673137|NCT01664559|Secondary|Post-insertion Provider Questionnaire|"The provider will be asked to fill out a multiple choice format questionnaire:
what level training are you?
which IUD was inserted?
what was the purpose of IUD placement?
what was the position of the uterus?
did the IUD placement process require cervical dilation?
were you able to complete the IUD insertion?
was there bleeding from the cervix that required more than 5 min to control?
were there any major complications with the IUD insertion?
did the patient take tylenol prior to leaving the office?"|Immediately after IUD placement, on average within 1 hour|||participants|||Number
673138|NCT01664559|Secondary|Post-insertion Patient Questionnaire|"Questions assessed in multiple choice format:
Side effects
injection site pain
overall satisfaction with IUD insertion experience
would they still recommend IUD placement to a friend?
significant pain for which they desired acetaminophen prior to leaving the office?"|assessed at 15 minutes after IUD insertion|||participants|||Number
673139|NCT01664559|Secondary|Nulliparous Patients - Subgroup Analysis|"The patient marked their pain on a 0 to 10cm visual analogue scale, where 0 cm is no pain and 10 cm is the worst pain ever.
Prior to injection of study drug, anticipated pain
Pain from study drug injection, measured immediately after injection
Pain from speculum insertion, measured immediately after insertion
Pain with tenaculum placement, measured immediately after placement
Pain with uterine sounding, measured immediately after removal of the sound
Pain at 5 minutes after placement of the intrauterine device
Pain at 15 minutes after placement of the intrauterine device"|immediately after each step (see description)|||cm||Inter-Quartile Range|Median
673140|NCT01664559|Secondary|Pain Scores at Other Time Points During and After IUD Placement|"The patient marked their pain on a 0 to 10cm visual analogue scale, where 0 cm is no pain and 10 cm is the worst pain ever.
Prior to injection of study drug, anticipated pain
Pain from study drug injection, measured immediately after injection
Pain from speculum insertion, measured immediately after insertion
Pain with tenaculum placement, measured immediately after placement
Pain with uterine sounding, measured immediately after removal of the sound
Pain at 5 minutes after placement of the intrauterine device
Pain at 15 minutes after placement of the intrauterine device"|immediately after each step (see description)|||cm||Inter-Quartile Range|Median
673141|NCT01664559|Primary|VAS (Visual Analogue Scale) Measurement of Pain|The patient marked their pain on a 0 to 10cm visual analogue scale, where 0 cm is no pain and 10 cm is the worst pain ever.|Pain with IUD placement, measured immediately after placement|||units on a scale||Inter-Quartile Range|Median
673142|NCT01664533|Secondary|Percentage of Participants Who Developed Diarrhea||Up to 2 years|Safety analysis population: All participants who received at least 1 dose of erlotinib. Data was missing for 1 participant.||percentage of participants||95% Confidence Interval|Number
673143|NCT01664533|Secondary|Percentage of Participants Who Developed Rash||Up to 2 years|Safety analysis population: All participants who received at least 1 dose of erlotinib. Data was missing for 1 participant.||percentage of participants||95% Confidence Interval|Number
673144|NCT01664533|Secondary|Overall Survival|Overall survival was defined as the time from Baseline until death from any cause.|Up to 2 years|||months||95% Confidence Interval|Median
673145|NCT01664533|Secondary|Best Overall Response|Reported are the percentage of participants with a best overall response of complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD). The best overall response to treatment was determined by the Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all target lesions (TL) or the disappearance of all non-TLs. A PR was defined as at least a 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD. SD was defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since treatment started for TLs and the persistence of 1 or more non-TL(s). PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs.|Baseline to the end of the study (up to 2 years)|Per-protocol population: All enrolled participants who started erlotinib therapy and did not violate the study protocol. Only participants with an evaluable response were included in the analysis.||Percentage of participants||97.5% Confidence Interval|Number
673146|NCT01664533|Primary|Progression-free Survival|Progression-free survival was defined as the time from the first dose of erlotinib to disease progression or death from any cause, whichever occurred earlier. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter of target lesions recorded since treatment started, or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.|Baseline to the end of the study (up to 2 years)|Per-protocol population: All enrolled participants who started erlotinib therapy and did not violate the study protocol.||Months||95% Confidence Interval|Median
673816|NCT01658514|Primary|AUC (0-t) of Plasma Metformin|AUC (0-t) = Area under the curve from the time of dosing (0 h) to the time of the last quantifiable concentration following dose administration|from the time of dosing (0 h) to 72 hours postdose|PK Evaluable Population||ng*h/mL||Standard Error|Least Squares Mean
673148|NCT01664494|Primary|Number of Participants With Routine Clinical Use of Capecitabine as Per the Line of Treatment|Choice of line of treatment in adjuvant and advanced or metastatic cancer for capecitabine was observed.|Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first|All enrolled participants were considered for this outcome measure.||Participants|||Number
673149|NCT01664247|Secondary|Change From Baseline in Patient Reported Health-related Quality of Life Using the Short-Form 36 Health Survey Version 2 (SF-36®v2)|Change in subject’s quality of life was evaluated using the Short-Form 36 Health Survey version 2 (SF-36®v2). Evaluations were performed at baseline and at the last treatment visit (week 26). SF-36 was assessed on a scale range of 0.65 to 80.73 for physical health and -8.81 to 81.65 for mental health respectively, where higher scores indicated a better quality of life. 0-100 scores from the SF-36 were converted to a norm-based score using a T-score transformation in order to obtain a direct interpretation in relation to the distribution of the scores in the 1998 U.S. general population.|Week 0, week 26|The FAS included all randomised subjects and missing data was imputed using LOCF. For 3 subjects PRO scores were missing at the baseline and did not contribute to the analysis.||T-scores||Standard Deviation|Mean
673150|NCT01664247|Secondary|Number of Adverse Events|Number of treatment emergent AEs (TEAEs) from week 0 to week 26 of the randomised treatment. A TEAE was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment.|Weeks 0 - 26|The SAS included all subjects who received at least one dose of the investigational product or its comparator.||events|||Number
673151|NCT01664247|Secondary|Number of Hypoglycaemic Episodes|Number of confirmed hypoglycaemic episodes from week 0 to 26 weeks of randomised treatment. A hypoglycaemic episode was defined as treatment emergent if the onset of the episode occurred after the first administration of investigational medicinal product and no later than 7 days after the last day on trial product. Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia or minor hypoglycaemic episodes.|Weeks 0 - 26|The safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or its comparator.||events|||Number
673152|NCT01664247|Secondary|Change From Baseline in Mean of the 8-point Profile|Change from baseline in mean of the 8-point profile after 26 weeks of randomised treatment.|Week 0, week 26|The FAS included all randomised subjects and missing data is imputed using LOCF. Mean values were missing for 11 subjects.||mmol/L||Standard Deviation|Mean
673153|NCT01664247|Secondary|Change From Baseline in 8-point Profile|The change from baseline in the 8-point SMPG profile after 26 weeks of randomised treatment. The least squares means presented are the estimated values after 26 weeks of treatment and the statistical analysis presents the treatment difference of the change from baseline values as the model is adjusted for baseline.|Week 0, week 26|The FAS included all randomised subjects. The subjects not analysed were 12, 45, 46, 44, 44, 54, 56 and 21 subjects for before breakfast, 90 mins after breakfast, before lunch, 90 mins after start of lunch, before main evening meal, 90 mins after main evening meal, before bedtime and before breakfast the following day time points respectively.||mmol/L||Standard Error|Least Squares Mean
673154|NCT01664247|Secondary|Change From Baseline in Mean Pre-breakfast Measurements Used for Titration|Change from baseline after 26 weeks of treatment in the average of the pre-breakfast self measured plasma glucose (SMPG) measured on the day of the contact and the two days immediately prior to the contact. The least squares means presented are the estimated values after 26 weeks of treatment and the statistical analysis presents the treatment difference of the change from baseline values as the model is adjusted for baseline.|Week 0, week 26|The FAS included all randomised subjects and missing data was imputed using LOCF. For 8 subjects the baseline values were missing||mmol/L||Standard Error|Least Squares Mean
673155|NCT01664247|Secondary|Number of Responders for HbA1c (Below 7.0 %)|Number of responders for HbA1c below 7.0%, after 26 weeks of randomised treatment.|After 26 weeks of randomised treatment.|The FAS included all randomised subjects and missing data was imputed using LOCF.||percentage (%) of subjects|||Number
673156|NCT01664247|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|Change from baseline in FPG after 26 weeks of treatment|Week 0, week 26|The FAS included all randomised subjects and missing data was imputed using LOCF. For 6 subjects FPG values were missing.||mmol/L||Standard Deviation|Mean
673157|NCT01664247|Primary|Change From Baseline in Glycosylated Haemoglobin (HbA1c) (%)|Change from baseline in HbA1c after 26 weeks of treatment|Week 0, week 26|The FAS included all randomised subjects and missing data was imputed using last observation carried forward (LOCF).||percentage of glycosylated haemoglobin||Standard Error|Least Squares Mean
673158|NCT01664117|Secondary|Number of Participants With Any Adverse Events and Any Serious Adverse Events|An Any Adverse Events (AEs) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An Serious Adverse Events (SAEs) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.|At the time of change of treatment (to the current treatment)|Analysis population included all enrolled participants who met the screening criteria.||Participants|||Number
673159|NCT01664117|Secondary|Number of Participants With Adverse Events Leading to a Change of Treatment|An Adverse Event was considered as any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Adverse events were collected as a reason for the change to monotherapy.|At the time of change of treatment|Analysis population included all enrolled participants who met the screening criteria.||Participants|||Number
673160|NCT01664117|Secondary|Number of Participants Falling Within Reference Values For C-reactive Protein and Erythrocyte Sedimentation Rate by Biologic Agent in Monotherapy at the Time of the Study|Participants who received biologic agent in monotherapy at the time of the study were assessed for C-reactive Protein (CRP) and Erythrocyte Sedimentation Rate (ESR).|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria.||participants|||Number
673161|NCT01664117|Secondary|Mean Number of Joint Count for Painful Joints and Swollen Joints by Biologic Agent in Monotherapy at the Time of the Study|Participants who received biologic agent in monotherapy at the time of the study were assessed for a number of painful joints (NPJ) and swollen joints (NSJ).|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria.||Number of joints||Standard Deviation|Mean
673162|NCT01664117|Secondary|Number of Participants With Categorization of Disease Activity Based on Disease Activity Score, Clinical Disease Activity Index Score and Simple Disease Activity Index Score|Mean score of categorization (remission/low activity and moderate/high activity) of DAS28 index, CDAI index, and SDAI index was recorded for participants who received biologic agent in monotherapy at the time of the study .|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria.||participants|||Number
673163|NCT01664117|Secondary|Mean Score on Disease Activity Score Based on 28-Joints Count, Clinical Disease Activity Index and Simple Disease Activity Index by Biologic Agent in Monotherapy at the Time of the Study|Mean score of DAS28 index, CDAI index, and SDAI index were recorded for participants who received biologic agent in monotherapy at the time of the study.|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria.||Units on a scale||Standard Deviation|Mean
673164|NCT01664117|Secondary|Number of sDMARD and bDMARDs Received Before the Study Treatment (Tocilizumab or Other Biologic Agent)||At Visit 1|Analysis Population included all enrolled participants who met the screening criteria. ‘n' signifies the number of participants analyzed at specified time point.||Number of sDMARD/bDMARDs/Other||Standard Deviation|Mean
673165|NCT01664117|Secondary|Mean Time of bDMARD Monotherapy Started at the Time of the Study Since Onset of RA||At Visit 1|Analysis Population included all enrolled participants who met the screening criteria. ‘n' signifies the number of participants analyzed at specified time point.||years||Standard Deviation|Mean
673166|NCT01664117|Secondary|Number of Participants Who Received Tocilizumab, Anti-Tumour Necrosis Factor and Other as a Monotherapy at the Time of the Study|Participants who received tocilizumab, Anti-tumour necrosis factor (TNF) and Other treatment of monotherapy were reported.|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria.||participants|||Number
673167|NCT01664117|Secondary|Number of Participants With Reasons for Starting Current Biologic Monotherapy|The reasons for changing current biologic treatment were recorded as lack of efficacy, adverse events, intolerance, clinical improvement and other.|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria.||participants|||Number
673168|NCT01664117|Secondary|Number of Participants Received Other Concomitant Treatments With the Current bDMARD Monotherapy|Other treatments included corticosteroids, NSAIDs and corticosteroid + NSAID.|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria.||participants|||Number
673169|NCT01664117|Secondary|Number of Participants Received Current bDMARD Treatment at the Time of the Study|Current bDMARD treatment included etanercept, infliximab, adalimumab, abatacept, tocilizumab, rituximab and certolizumab.|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria.||participants|||Number
673170|NCT01664117|Secondary|Number of Participants Treated With Concomitant Medications Before the Study|Participants received concomitant medications (corticosteroids, non-steroidal anti-inflammatory drugs [NSAID], and other treatment) before the study were presented.|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria.||participants|||Number
673171|NCT01664117|Secondary|Median Time Taking the Biologic Agent in Monotherapy Before the Study Treatment|Median time in months taking the Biologic Agent in monotherapy before the study was presented.|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria. ‘n' signifies the number of participants analyzed at specified time point.||Months||Full Range|Median
673172|NCT01664117|Secondary|Number of Participants Discontinued the Previous Treatment and Started the Study Treatment|The reasons for changing the previous sDMARD, sDMARD+ bDMARD or bDMARD treatment and starting the study treatment were recorded as lack of efficacy, adverse events, intolerance, clinical improvement, and other.|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria.||participants|||Number
673173|NCT01664117|Secondary|Number of Participants Received sDMARD, sDMARD+ bDMARD or bDMARD Immediately Before the Study Treatment||At Visit 1|Analysis Population included all enrolled participants who met the screening criteria.||participants|||Number
673174|NCT01664117|Secondary|Number of sDMARD and bDMARDs Received Before the Study Treatment (bDMARD Monotherapy)|Number of sDMARD and bDMARDs received by Participants before the study was presented|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria. ‘n' signifies the number of participants analyzed at specified time point.||Number of sDMARD/bDMARD||Standard Deviation|Mean
673175|NCT01664117|Secondary|Number of Participants With Changing the Previous sDMARD/ bDMARD|Any reasons for changing the previous sDMARD/bDMARD treatment were recorded as lack of efficacy, adverse events, intolerance, clinical improvement and other. There may be more than one reason for changing sDMARD/ bDMARD per participant.|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria. ‘n’ represents the number of participants analyzed at a specified time point.||Participants|||Number
673176|NCT01664117|Secondary|Mean Time Between the Last sDMARD and bDMARD Received at Visit 1|Mean time between the last sDMARD and bDMARD received at Visit 1 was presented in months.|At Visit 1|Analysis Population included all enrolled participants who met the inclusion criteria. ‘n' signifies the number of participants analyzed at specified time point.||Months||Standard Deviation|Mean
673177|NCT01664117|Secondary|Number of Participants Who Received Each bDMARD Before the Study|Number of participant who received bDMARD (etanercept, infliximab, golimumab, adalimumab, abatacept, tocilizumab, rituximab) before the study was reported in at Visit 1.|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria.||participants|||Number
673178|NCT01664117|Secondary|Number of Participants Prescribed First bDMARD Before the Study|Number of participants prescribed first bDMARD before the study was presented.|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria.||Participants|||Number
673179|NCT01664117|Secondary|Number of Participants Who Received Last sDMARD Prescribed Before the Study|Number of participants who previously received sDMARDs before the study in at Visit 1 was reported. sDMARDS included azathioprine, penicillamine, sulfasalazine, hydroxychloroquine, gold salts, leflunomide, ciclosporin, methotrexate, and leflunomide + methotrexate.|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria.||participants|||Number
673857|NCT01657292|Secondary|Assessment of Adverse Events||2 to 3 weeks||||||
673858|NCT01657292|Secondary|Microbial Colonization of the Wound Halves||2 to 3 weeks||||||
673180|NCT01664117|Secondary|Number of Participants Who Received Each sDMARD Before The Study|Number of participants who previously received sDMARDs before the study in at Visit 1 was reported. sDMARDS included azathioprine, penicillamine, sulfasalazine, hydroxychloroquine, gold salts, chloroquine, leflunomide, ciclosporin, methotrexate, and chlorambucil medications.|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria.||Participants|||Number
673181|NCT01664117|Secondary|Mean Time Between Diagnosis and Prescription of First Synthetic Disease-Modifying Antirheumatic Drug or First Biologic Disease-Modifying Antirheumatic Drug|Mean time in months at Visit 1 between diagnosis and prescription of first sDMARD/ first bDMARD was presented.|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria. ‘n’ = number of participants prescribed with first sDMARD or bDMARD.||Months||Standard Deviation|Mean
673182|NCT01664117|Secondary|Number of Participants Prescribed First Synthetic Disease-Modifying Antirheumatic Drug Therapy Before the Study|Number of participants prescribed with first synthetic disease-modifying antirheumatic drug therapy (sDMARD) in monotherapy and in a combination before the study was presented.|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria.||Participants|||Number
673183|NCT01664117|Primary|Number of Participants With Simple Disease Activity Index Score by Categorization at Visit 1|SDAI is divided into 4 categories as: remission (<3.3), low activity (3.3-11), moderate activity (11-26) and high activity (>26).|At Visit 1|Analysis population included all enrolled participants who met the screening criteria.||Participants|||Number
673184|NCT01664117|Primary|Mean Score on Simple Disease Activity Index at Visit 1|Simple Disease Activity Index (SDAI) is calculated by sum of number of painful joint and swollen joint count, patient and physician global assessment of disease activity (VAS 0-10 cm), and level of C-reactive protein in milligrams per deciliter (mg/dL). SDAI total score ranges from 0 to 86, where higher scores indicates greater affect due to disease activity.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria.||Scores on a scale||Standard Deviation|Mean
673185|NCT01664117|Primary|Number of Participants With Clinical Disease Activity by Categorization at Visit 1|CDAI is divided into 4 categories as: remission <2.8, low activity 2.8-10, moderate 10-22 and high>22.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria.||Participants|||Number
673186|NCT01664117|Primary|Mean Score on Clinical Disease Activity Index at Visit 1|Clinical disease activity index (CDAI) of participants is a composite index that is calculated as the sum of number of painful joint, number of swollen joint, patient's VAS (0-10 cm) assessment, physician global VAS assessment (0-10 cm). The CDAI score ranges from 0 to 76, where lower scores indicate less disease activity.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria.||Scores on a scale||Standard Deviation|Mean
673187|NCT01664117|Primary|Number of Participants With Disease Activity Score by Categorization at Visit 1|DAS28 is divided into 4 categories as: remission <2.6, low activity 2.6-3.2, moderate 3.2-5.1 and high >5.1.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria.||Participants|||Number
673188|NCT01664117|Primary|Mean Score on Disease Activity Score Based on 28-Joints Count at Visit 1|Disease activity score (DAS) 28 is a combined index for measuring disease activity in RA. The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores indicate worsening.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria.||Units on a scale||Standard Deviation|Mean
673189|NCT01664117|Primary|Number of Participants With Joint Damage at Visit 1|Number of participants with joint damage is recorded as yes and no.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria.||Participants|||Number
673190|NCT01664117|Primary|Patient Pain Visual Analog Scale Score at Visit 1|"Participants assessed their pain using a 0 to 10 horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 and is described as no pain and the right-hand extreme equals 10 as unbearable pain"|At Visit 1|Analysis population included all enrolled participants who met the screening criteria. Out of 209 participants, 207 were analysed for patient pain visual analog scale.||Units on a scale||Standard Deviation|Mean
673191|NCT01664117|Primary|Number of Participants With C-reactive Protein and Erythrocyte Sedimentation Rate Falling Within Reference Values at Visit 1|The test for C-reactive Protein (CRP) is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultra-sensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Erythrocyte sedimentation rate (ESR) is a laboratory test that provides a non-specific measure of inflammation. A higher rate is consistent with inflammation.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria.||Participants|||Number
673192|NCT01664117|Primary|Number of Participants With Presence/Absence Rheumatoid Factor and Anti-Cyclic Citrullinated Protein Antibodies|Rheumatoid Factor (RF) is the auto antibody directed against Immunoglobulin G and its concentration is observed in human serum or plasma. Anti-Cyclic Citrullinated Protein Antibodies (Anti-CCP) antibodies are auto antibodies (antibodies directed against 1 or more of an individual’s own proteins) that are frequently detected in the blood of rheumatoid arthritis participants.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria. n =number of evaluated participants||Participants|||Number
673193|NCT01664117|Primary|Number of Participants With Biochemistry Parameters Values Falling Within Reference Values at Visit 1|Biochemistry parameters is considered as one of the component of clinical characteristics. Biochemistry parameters included alanine amino transferase (ALT), aspartate amino transferase (AST), triglycerides, total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), and total lipids.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria. 'n' =number of evaluated participants||Participants|||Number
673194|NCT01664117|Primary|Number of Participants With Hematology Parameters Values Falling Within Reference Values at Visit 1|Hematology parameters are considered as one of the component of clinical characteristics. Hematology parameters included white blood cells (WBC), platelets, red blood cells (RBC), hemoglobin, hematocrit, neutrophils, basophils, eosinophils, lymphocytes, monocytes.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria. n =number of evaluated participants||Participants|||Number
673195|NCT01664117|Primary|Patient’s Global Assessment of Disease Activity at Visit 1|Patient global assessment of disease activity visual analog scale is assessed using a 0 to 100 mm horizontal VAS. The left-hand extreme of the line equals 0 mm, and is described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as “maximum disease activity” (maximum arthritis disease activity).|At Visit 1|Analysis population included all enrolled participants who met the screening criteria.||Units on a scale||Standard Deviation|Mean
673196|NCT01664117|Primary|Physician’s Global Assessment of Disease Activity at Visit 1|The Physician’s global assessment of disease activity is assessed using a 0 to 100 millimeter (mm) horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 mm, and is described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as “maximum disease activity” (maximum arthritis disease activity).|At Visit 1|Analysis population included all enrolled participants who met the screening criteria.||Units on a scale||Standard Deviation|Mean
673197|NCT01664117|Primary|Mean Number of Painful and Swollen Joints at Visit 1|Participants were assessed for painful and swollen joints at Visit 1. Painful joint is the most specific clinical method to quantify abnormalities in participants with RA. It reflects the amount of inflamed synovial tissue.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria.||Number of joints||Standard Deviation|Mean
673198|NCT01664117|Primary|Number of Participants With Extra-articular Manifestations at Visit 1|Extra-articular manifestations (EAMs) are a component of of clinical characteristics EAMs are symptoms and diseases that occur in parts of the body other than joints. These included the presence of amyloidosis (rare disease that results from the buildup of misfolded proteins), anemia (deficiency of red cells in the blood), heart complications, lung complications, rheumatoid nodules (local swelling), felty’s syndrome (presence of rheumatoid arthritis, an enlarged spleen, and an abnormally low white blood cell count), and secondary Sjogren's (an autoimmune disorder that damages moisture-producing glands, making it difficult to produce saliva and tears). Participants were assessed into categories with extra-articular Manifestations as yes, no and missing nos.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria.||Participants|||Number
673199|NCT01664117|Primary|Number of Participants With Co-morbidities|Co-morbidity is a component of clinical characteristics It included stroke, heart failure (grades I, II, III or IV), ischemic heart disease, hypertension, dyslipidemia, osteoporosis, interstitial lung disease, chronic obstructive pulmonary disease (COPD), depression, diabetes mellitus, liver disease, serious infections, tuberculosis, hematological malignancies, solid tumors and others. Participants were assessed into categories with associated co-morbidities as yes and no.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria.||Participants|||Number
673200|NCT01664117|Primary|Number of Participants With Family History of Rheumatoid Arthritis|Family history is a component of clinical characteristics. Participants who had a family history of rheumatoid arthritis is recorded as yes/no. Also, family history related to parents, siblings, aunts and uncles, grandparents, or other is recorded.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria.||Participants|||Number
673201|NCT01664117|Primary|Mean Time of Onset of Rheumatoid Arthritis|Onset of rheumatoid arthritis is a component of clinical characteristics.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria.||Years||Standard Deviation|Mean
673202|NCT01664117|Primary|Smoking-habit or Smokers or Ex-smokers (Smoking/Quit Smoking )|Smoking-habit included years of smoking/quit smoking is reported for participants.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria. 'n' = number of evaluated participants||Years||Standard Deviation|Mean
673203|NCT01664117|Primary|Smoking-habit for Smokers or Ex-smokers (Packs in Years)|Smoking-habit included number of pack per years is reported.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria. n = number of evaluated participants||Years||Standard Deviation|Mean
673204|NCT01664117|Primary|Number of Participants With Smoking Habits|Smoking habits is a component of socio-demographic characteristics. Participants’ smoking status is recorded as non-smoker, smoker, and ex-smoker at Visit 1.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria.||Participants|||Number
673205|NCT01664117|Primary|Number of Participants With Level of Education Completed|Level of education completed is a component of socio-demographic characteristics. It is recorded as cannot read, no formal education, primary education or equivalent, general secondary education, vocational education, and higher education or equivalent. Data were collected at study entry (Single visit study)|At Visit 1 (Single visit study)|Analysis population included all enrolled participants who met the screening criteria||Participants|||Number
673206|NCT01664104|Secondary|Correlation Coefficient Between BMI at the Start of TCZ Treatment and VAS Fatigue at Month 6|Participants measured the level of fatigue due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 mm = no fatigue to 100 mm = extreme fatigue. The Pearson and Spearman correlation coefficients can range in value from −1 to +1.|Baseline and Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.||correlation coefficient|||Number
673207|NCT01664104|Secondary|Correlation Coefficient Between Change From Baseline in CRP (mg/dL) and Change From Baseline in Morning Stiffness According to VAS at Month 6|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Morning stiffness was defined as the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant reported the duration of morning stiffness in the case report form by ticking 1 of the following categories: no morning stiffness, < 30 minutes, 30 - 60 minutes, 60 - 120 minutes, 120 - 240 minutes, > 240 minutes, and the whole day. The Pearson and Spearman correlation coefficients can range in value from −1 to +1.|Baseline and Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.||correlation coefficient|||Number
673259|NCT01664104|Secondary|Tender Joint Count (TJC) at Baseline|TJC was determined by examining 28 joints and identifying the joints that were painful under pressure or to passive motion. Tenderness was recorded on the joint assessment form at baseline; no tenderness = 0 and tenderness = 1.|Baseline|All enrolled participants evaluable for primary objective with available data for this outcome measure.||tender joints||Standard Deviation|Mean
673208|NCT01664104|Secondary|Correlation Coefficient Between BMI at the Start of TCZ Treatment and HAQ-DI (0-3) at Month 6|The HAQ-DI is a questionnaire that measures functional status (disability) and health-related QoL. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene,reach, grip and common activities over past week. Each question was evaluated according to the degree of severity on a 4-point scale ranging from 0 = without any difficulty to 3 = unable to do. Total score is the average of all questions, which ranges from 0 to 3, where higher scores represent higher disease activity. The Pearson and Spearman correlation coefficients can range in value from −1 to +1.|Baseline and Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.||correlation coefficient|||Number
673209|NCT01664104|Secondary|Correlation Coefficient Between Change From Baseline in CRP (mg/dL) at the Start of TCZ Treatment and Change From Baseline in VAS Fatigue at Month 6|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Participants measured the level of fatigue due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 mm = no fatigue to 100 mm = extreme fatigue. The Pearson and Spearman correlation coefficients can range in value from −1 to +1.|Baseline and Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.||correlation coefficient|||Number
673210|NCT01664104|Secondary|Correlation Coefficient Between CRP (mg/dL) at the Start of TCZ Treatment and VAS Fatigue at Month 6|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Participants measured the level of fatigue due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 mm = no fatigue to 100 mm = extreme fatigue. The Pearson and Spearman correlation coefficients can range in value from −1 to +1.|Baseline and Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.||correlation coefficient|||Number
673211|NCT01664104|Secondary|Correlation Coefficient Between Change From Baseline in CRP (mg/dL) and HAQ-DI (0-3) at Month 6|CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in level of CRP indicates reduction in inflammation and therefore improvement. HAQ-DI is a questionnaire that measures functional status (disability) and health-related QoL. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities over past week. Each question was evaluated according to the degree of severity on a 4-point scale ranging from 0= without any difficulty to 3= unable to do. Total score is the average of all questions, which ranges from 0 to 3, where higher scores represent higher disease activity. The Pearson and Spearman correlation coefficients can range in value from −1 to +1.|Baseline and Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.||correlation coefficient|||Number
673212|NCT01664104|Secondary|Correlation Coefficient Between CRP (mg/dL) at the Start of TCZ Treatment and HAQ-DI (0-3) at Month 6|The test for CRP is laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in level of CRP indicates reduction in inflammation and therefore improvement. HAQ-DI is a questionnaire that measures functional status (disability) and health-related QoL. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities over past week. Each question was evaluated according to the degree of severity on a 4-point scale ranging from 0 = without any difficulty to 3 = unable to do. Total score is average of all questions, which ranges from 0 to 3, where higher scores represent higher disease activity. The Pearson and Spearman correlation coefficients can range in value from −1 to +1.|Baseline and Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.||correlation coefficient|||Number
673213|NCT01664104|Secondary|BMI at the Start of TCZ Treatment by Morning Stiffness at Month 6|Morning stiffness was defined as the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant reported the duration of morning stiffness in the case report form by ticking the categories: ≤ 30 minutes and > 30 minutes.|Baseline|All enrolled participants evaluable for primary objective. Here, Number of participants analyzed = participants evaluable for the outcome measure and number analyzed = participants with available data for specified category.||Kg/m^2||Standard Deviation|Mean
673214|NCT01664104|Secondary|CRP at the Start of TCZ Treatment by Morning Stiffness at Month 6|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. The participant reported the duration of morning stiffness in the case report form by ticking the categories: ≤ 30 minutes and > 30 minutes.|Baseline|All enrolled participants evaluable for primary objective. Here, Number of participants analyzed = participants evaluable for this outcome measure and number analyzed = participants with available data for specified category.||mg/dL||Standard Deviation|Mean
673215|NCT01664104|Secondary|Percentage of Participants by Duration of Morning Stiffness|Duration of morning stiffness was defined as the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant reported the duration of morning stiffness in the case report form by ticking 1 of the following categories: no morning stiffness, < 30 minutes, 30 - 60 minutes, 60 - 120 minutes, 120 - 240 minutes, > 240 minutes, and the whole day. 'Not estimable' represented that the participants were not able to quantify it. 'Not done' represented that the assessment was not performed.|Month 3 and Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.||percentage of participants|||Number
673859|NCT01657292|Secondary|PK Data: Systemic Presence/Concentration of Betulin in Blood Plasma Samples||2 to 3 weeks||||||
673216|NCT01664104|Secondary|Percentage of Participants With and Without Morning Stiffness|"Morning stiffness was defined by the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant assessed morning stiffness based on the following criteria:
Presence of participant's joints stiff when woke up that day, measured as yes (stiffness present) or no (stiffness not present);
Duration of morning stiffness, measured by ticking 1 of the six categories: < 30 minutes, 30 - 60 minutes, 60 - 120 minutes, 120 - 240 minutes, > 240 minutes, and the whole day;
Severity of morning stiffness measured using a ruler on a 100 mm VAS where the responses were on a continuous range from 0 mm = no stiffness to 100 mm = maximum stiffness.
'Not estimable' represented that the participants were not able to quantify it. 'Not done' represented that the assessment was not performed."|Month 3 and Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.||percentage of participants|||Number
673217|NCT01664104|Secondary|Body Mass Index (BMI) at the Start of TCZ Treatment by Remission Status Using DAS-28 CRP, SDAI, and CDAI at Month 6|DAS28 scale ranges from 0 to 10, and calculated as DAS28 = 0.56 x √TJC28 + 0.28 x √SJC28 + 0.36 x ln(CRP + 1) + 0.014 x PGH + 0.96, where TJC28 and SJC28 = tender joint and swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = managing very well and 100 mm = managing very poorly, CRP = serum concentration of C-reactive protein. A score of < 2.6 represents clinical remission. SDAI is a combined index for measuring disease activity in RA and calculated as SDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm) + CRP (in mg/dL), where PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = no arthritis activity and 100mm = extremely active arthritis. A SDAI score of ≤ 3.3 represents clinical remission. CDAI is a combined index for measuring disease activity in RA and calculated as CDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm). A CDAI score of ≤ 2.8 represents clinical remission.|Baseline|All enrolled participants evaluable for primary objective. Here, Number of participants analyzed = participants evaluable for this outcome measure and number analyzed = participants with available data for specified category.||kilogram per meter square (Kg/m^2)||Standard Deviation|Mean
673218|NCT01664104|Secondary|CRP at the Start of TCZ Treatment by Remission Status Using DAS28-CRP, SDAI, and CDAI at Month 6|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. DAS28 is calculated as follows: DAS28 = 0.56 x √TJC28 + 0.28 x √SJC28 + 0.36 x ln(CRP + 1) + 0.014 x PGH + 0.96, A score of < 2.6 represents clinical remission. SDAI is a combined index for measuring disease activity in RA and calculated as SDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm) + CRP (in mg/dL). A SDAI score of ≤ 3.3 represents clinical remission. CDAI is a combined index for measuring disease activity in RA and calculated as CDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm). A CDAI score of ≤ 2.8 represents clinical remission.|Baseline|All enrolled participants evaluable for primary objective. Here, Number of participants analyzed = participants evaluable for this outcome measure and number analyzed = participants with available data for specified category.||mg/dL||Standard Deviation|Mean
673219|NCT01664104|Secondary|Change From Baseline in ESR at Month 3 and Month 6|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A decrease in the level indicates reduction in inflammation and therefore improvement. Change from baseline = ESR level at Month X – ESR level at baseline. Here X = 3 and 6 for Change at Months 3 and 6, respectively.|Baseline, Month 3, and Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.||mm/hr||Standard Deviation|Mean
673220|NCT01664104|Secondary|Change From Baseline in CRP at Month 3 and Month 6|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Change from baseline = CRP level at Month X – CRP level at baseline. Here X = 3 and 6 for Change at Months 3 and 6, respectively.|Baseline, Month 3, and Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.||mg/dL||Standard Deviation|Mean
673221|NCT01664104|Secondary|Time to Steroid Dose Withdrawal|"Steroids that met the criteria for concomitant medications were selected. The time to steroid dose withdrawal was calculated as the difference between date of withdrawal and the date of first TCZ infusion."|Baseline up to Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.||months||Inter-Quartile Range|Median
673222|NCT01664104|Secondary|Time to Steroid Dose Reduction|"Steroids that met the criteria for concomitant medications were selected. The time to steroid dose reduction was calculated as the difference between date of dose reduction and the date of first TCZ infusion. For participants presenting more than one steroid dose reduction, only the first dose reduction was considered."|Baseline up to Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.||months||Inter-Quartile Range|Median
673223|NCT01664104|Secondary|Percentage of Participants by Reason for DMARD Withdrawal During the Study|"DMARDs that met the criteria for concomitant medications were selected. All treatments with DMARDs interrupted after the first TCZ infusion were selected."|Baseline up to Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.||percentage of participants|||Number
673224|NCT01664104|Secondary|Time to DMARD Dose Withdrawal|"DMARDs that met the criteria for concomitant medications were selected. The time to DMARD withdrawal was calculated as the difference between date of withdrawal and the date of first TCZ infusion."|Baseline up to Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.||months||Inter-Quartile Range|Median
673225|NCT01664104|Secondary|Time to DMARD Dose Reduction|"DMARDs that met the criteria for concomitant medications were selected. The time to DMARD dose reduction was calculated as the difference between date of dose reduction and the date of first TCZ infusion. For participants presenting more than 1 DMARD dose reduction, only the first dose reduction was considered."|Baseline up to Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.||months||Inter-Quartile Range|Median
678089|NCT01601977|Secondary|Health Related Quality of Life|Severe Respiratory Insufficiency (SRI) questionnaire. Higher scores indicate better quality of life (minimum 0, maximum 100)|2 weeks|||units on a scale||Standard Deviation|Mean
673226|NCT01664104|Secondary|Percentage of Participants Achieving Good/Moderate/No European League Against Rheumatism (EULAR) Response at Month 3 and Month 6|Clinical response was assessed according to EULAR criteria that classified the participant according to individual changes in DAS28 score as good, moderate, or no response. DAS28 score is a measurement of RA activity on 0 to 10 scale and calculated as DAS28= 0.56 x √TJC28 + 0.28 x √SJC28 + 0.36 x ln(CRP + 1) + 0.014 x PGH + 0.96, where TJC28= tender joint count on 28 units, SJC28= swollen joint count on 28 units, CRP= serum concentration of C-reactive protein (after converting units to mg/dL), PGH= patient's global assessment of disease activity measured on a 100 mm VAS, where 0 mm= managing very well and 100 mm= managing very poorly. Good responders experienced change (chg) from baseline (BL) of >1.2 with DAS28 score ≤ 3.2, moderate responders experienced chg from BL >1.2 with DAS28 score > 3.2 to ≤ 5.1 or a chg from BL > 0.6 to ≤ 1.2 with DAS28 score of ≤ 5.1. No responders experienced chg from BL < 0.6 regardless initial DAS28 score or > 0.6 to ≤ 1.2 with DAS28 score of > 5.1.|Month 3 and Month 6|All enrolled participants evaluable for primary objective. Here, Number of participants analyzed= participants evaluable for the outcome measure and number analyzed = participants with available data for specified category.||percentage of participants|||Number
673227|NCT01664104|Secondary|Percentage of Participants With Clinically Meaningful Improvement in HAQ-DI|The HAQ-DI is a questionnaire that measures functional status (disability) and health-related QoL. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common activities over past week. Each question was evaluated according to the degree of severity on a 4-point scale ranging from 0 = without any difficulty to 3 = unable to do. Total score for HAQ-DI is the average of all the questions, which ranges from 0 to 3, where higher scores represent higher disease activity. HAQ-DI clinically meaningful improvement is defined as decrease in HAQ total score from baseline of greater or equal to 0.22 points.|Month 3 and Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.||percentage of participants|||Number
673228|NCT01664104|Secondary|Change From Baseline to Month 6 in Participant Assessment of Morning Stiffness|The participant assessment of morning stiffness was measured using a ruler on a 100 mm VAS, where the responses were on a continuous range from 0 mm = no stiffness and 100 mm = maximum stiffness.|Baseline and Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.||mm||Standard Deviation|Mean
673229|NCT01664104|Secondary|Change From Baseline to Month 6 in Participant Assessment of Fatigue|Participants measured the level of fatigue due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 mm = no fatigue to 100 mm = extreme fatigue.|Baseline and Month 6|All enrolled participants evaluable for the primary objective with available data for this outcome measure.||mm||Standard Deviation|Mean
673230|NCT01664104|Secondary|Change From Baseline to Month 6 in HAQ-DI Score|The HAQ-DI is a questionnaire that measures functional status (disability) and health-related QoL. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities over past week. Each question was evaluated according to the degree of severity on a 4-point scale ranging from 0 = without any difficulty to 3 = unable to do.Total score for HAQ-DI is the average of all the questions, which ranges from 0 to 3, where higher scores represent higher disease activity.|Baseline and Month 6|All enrolled participants evaluable for the primary objective with available data for this outcome measure.||units on a scale||Standard Deviation|Mean
673231|NCT01664104|Secondary|Change From Baseline to Month 6 in Patient's Assessment of Pain|Participants measured the pain intensity due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 mm = no pain to 100 mm = unbearable pain.|Baseline and Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.||mm||Standard Deviation|Mean
673232|NCT01664104|Secondary|Change From Baseline to Month 6 in PhGH|The PhGH was evaluated using a 100 mm VAS where 0 mm = no arthritis activity and 100 mm = extremely active arthritis. Higher scores indicated increased level of disease.|Baseline and Month 6|All enrolled participants evaluable for the primary objective with available data for this outcome measure.||mm||Standard Deviation|Mean
673233|NCT01664104|Secondary|Change From Baseline to Month 6 in PGH|The PGH was measured using a 100 mm VAS, where the responses were on a continuous range from 0 mm = managing very well and 100 mm = managing very poorly.|Baseline and Month 6|All enrolled participants evaluable for the primary objective with available data for this outcome measure.||mm||Standard Deviation|Mean
673234|NCT01664104|Secondary|Change From Baseline to Month 6 in SJC|SJC was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at baseline and at Month 6. No swelling = 0 and swelling = 1.|Baseline and Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.||swollen joints||Standard Deviation|Mean
673235|NCT01664104|Secondary|Change From Baseline to Month 6 in TJC|TJC was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at baseline and at Month 6. No tenderness = 0 and tenderness = 1.|Baseline and Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.||tender joints||Standard Deviation|Mean
673260|NCT01664104|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Baseline|The HAQ-DI is a questionnaire that measures functional status (disability) and health-related quality of life (QoL). It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common activities over past week. Each question was evaluated according to the degree of severity on a 4-point scale ranging from 0 = without any difficulty to 3 = unable to do. Total score for HAQ-DI is the average of all questions and ranges from 0 to 3, where higher scores represent higher disease activity.|Baseline|All enrolled participants evaluable for primary objective with available data for this outcome measure.||units on a scale||Standard Deviation|Mean
678414|NCT01598207|Secondary|Sensory Thresholds for Pain|When highest amount of pain was felt; range is 0-65 mmHg|Baseline and 1 month|1 participant in marinol and 1 participant in placebo did not have this information completed||mmHg||Standard Deviation|Mean
673236|NCT01664104|Secondary|Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, 70%, or 90% (ACR20/50/70/90) Response After Month 3 and Month 6 From the Start of TCZ Treatment|ACR20, 50, 70 or 90 response = an improvement of ≥20%, ≥50%, ≥70% or ≥90% respectively, as compared to baseline in TJC28 and SJC28, and 20/50/70/90%, improvement in at least 3 of 5 following measures: Patient's Assessment of Pain over previous 24 hours, PGH, PhGH, HAQ, and acute phase reactant (either CRP or ESR). TJC and SJC, based on 28-joint assessments. Number of tender joints and swollen joints were recorded on joint assessment form at baseline; no tenderness = 0 and tenderness = 28, no swelling = 0 and swelling = 28, respectively. HAQ measures functional status (disability) and health-related QoL with 20 questions, summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities over past week, 0= without difficulty to 3= unable to do. Patient’s assessment of pain assessed using VAS; 0 mm = no pain, 100 mm = unbearable pain; PGH and PhGH, assessed using VAS; 0 mm = no disease activity, 100 mm = maximum disease activity.|Month 3 and Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.||percentage of participants|||Number
673237|NCT01664104|Secondary|Percentage of Participants by CDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6|CDAI is a combined index for measuring disease activity in RA and calculated as CDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm), where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = managing very well and 100 mm = managing very poorly, and PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = no arthritis activity and 100 mm = extremely active arthritis. CDAI total score ranged from 0-76. Higher scores indicate greater disease activity. CDAI score of ≤ 2.8 represents clinical remission, score of ≤ 10.0 represents low disease activity, score of ≤ 22.0 represents moderate disease activity, and score of > 22.0 represents high (or severe) disease activity.|Baseline, Month 3, and Month 6|All enrolled participants evaluable for primary objective. Here, Number of participants analyzed= participants evaluable for the outcome measure and number analyzed = participants with available data for specified category.||percentage of participants|||Number
673238|NCT01664104|Secondary|Percentage of Participants by SDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6|SDAI is a combined index for measuring disease activity in RA and calculated as SDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm) + CRP (in mg/dL), where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = managing very well and 100 mm = managing very poorly, PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 = no arthritis activity and 100 = extremely active arthritis, CRP = serum concentration of C-reactive protein. SDAI total score ranged from 0-86. Higher scores represent greater disease activity. SDAI scores of ≤ 3.3 represents clinical remission, ≤ 11.0 represents low disease activity, ≤ 26.0 represents moderate disease activity, and > 26.0 represents high (or severe) disease activity.|Baseline, Month 3, and Month 6|All enrolled participants evaluable for primary objective. Here, Number of participants analyzed = participants evaluable for the outcome measure and number analyzed = participants with available data for specified category.||percentage of participants|||Number
673239|NCT01664104|Secondary|Percentage of Participants by DAS28 Class at the Start of TCZ Treatment and After Month 3 and Month 6|DAS28 score is a measurement of RA activity on a 0 to 10 scale and calculated as DAS28 = 0.56 x √TJC28 + 0.28 x √SJC28 + 0.36 x ln(CRP + 1) + 0.014 x PGH + 0.96, where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, CRP = serum concentration of c-reactive protein (after converting units to mg/dL), PGH = patient's global assessment of disease activity, which was measured on a 100 mm VAS, where 0 mm = managing very well and 100 mm = managing very poorly. Higher scores represent greater disease activity. A score of < 2.6 represents clinical remission, a score of ≥ 2.6 and ≤ 3.2 represents low disease activity, a score of >3.2 and ≤ 5.1 represents moderate disease activity, and a score of > 5.1 represents high (or severe) disease activity.|Baseline, Month 3, and Month 6|All enrolled participants evaluable for primary objective. Here, Number of participants analyzed= participants evaluable for this outcome and number analyzed = participants with available data for specified category.||percentage of participants|||Number
673240|NCT01664104|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Month 3 and Month 6|The CDAI is a combined index for measuring disease activity in RA and calculated as CDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm), where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly, and PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = no arthritis activity and 100 mm = extremely active arthritis. CDAI total score ranged from 0-76. Higher scores indicate greater disease activity. CDAI score of ≤ 2.8 represents clinical remission, score of ≤ 10.0 represents low disease activity, score of ≤ 22.0 represents moderate disease activity, and score of > 22.0 represents high (or severe) disease activity. Change from baseline = CDAI score at Month X – CDAI score at baseline. Here X = 3 and 6 for Change at Months 3 and 6, respectively.|Baseline, Month 3, and Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.||units on a scale||Standard Deviation|Mean
673241|NCT01664104|Secondary|Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Month 3 and Month 6|SDAI is a combined index for measuring disease activity in RA and calculated as SDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm) + CRP (in mg/dL), where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly, PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = no arthritis activity and 100 mm = extremely active arthritis, CRP = serum concentration of C-reactive protein. SDAI total score ranged from 0-86. Higher scores represent greater disease activity. SDAI scores of ≤ 3.3 represents clinical remission, ≤ 11.0 represents low disease activity , ≤ 26.0 represents moderate disease activity, and > 26.0 represents high (or severe) disease activity. Change from baseline = SDAI score at Month X – SDAI score at baseline. Here X = 3 and 6 for Change at Months 3 and 6, respectively.|Baseline, Month 3, and Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.||units on a scale||Standard Deviation|Mean
673242|NCT01664104|Secondary|Change From Baseline in Disease Activity Score Based on 28 Joint Count (DAS28) Score at Month 3 and Month 6|DAS28 score is a measurement of RA activity on a 0 to 10 scale, with higher scores representing higher disease activity, and calculated as DAS28 = 0.56 x √TJC28 + 0.28 x √SJC28 + 0.36 x natural logarithm (ln) (CRP + 1) + 0.014 x PGH + 0.96, where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, CRP = serum concentration of c-reactive protein (after converting units to mg/dL), PGH = patient global assessment of disease activity, which was measured on a 100 mm VAS, where 0 mm = managing very well and 100 mm = managing very poorly (√ = square root). A score of < 2.6 represents clinical remission, a score of greater than or equal to (≥) 2.6 and less than or equal to (≤) 3.2 represents low disease activity, a score of > 3.2 and ≤ 5.1 represents moderate disease activity and a score of > 5.1 represents high (or severe) disease activity. Change from baseline = DAS28 at Month X – DAS28 at baseline. Here X = 3 and 6 for Change at Months 3 and 6, respectively.|Baseline, Month 3, and Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.||units on a scale||Standard Deviation|Mean
673243|NCT01664104|Secondary|Percentage of Participants by Reason for Choice of TCZ Monotherapy at Baseline||Baseline|All enrolled participants evaluable for primary objective with available data for this outcome measure.||percentage of participants|||Number
673244|NCT01664104|Secondary|Percentage of Participants With TCZ Reintroduction|"The percentage of participants with at least one TCZ reintroduction was reported as Yes. Participants with unknown TCZ reintroduction were set to No."|Baseline up to Month 6|All enrolled participants evaluable for primary objective.||percentage of participants|||Number
673245|NCT01664104|Secondary|Percentage of Participants Who Discontinued TCZ by Reason for Discontinuation||Baseline up to Month 6|All enrolled participants evaluable for primary objective who discontinued TCZ.||percentage of participants|||Number
673246|NCT01664104|Secondary|Percentage of Participants With TCZ Infusion Interruption|"The percentage of participants with at least one infusion interruption was reported as Yes. Participants with unknown infusion interruption were set to No."|Baseline up to Month 6|All enrolled participants evaluable for primary objective.||percentage of participants|||Number
673247|NCT01664104|Secondary|Time in Days Elapsed Between TCZ Infusions|The time elapsed in days between TCZ infusions was calculated as the difference between the date of TCZ infusion and the date of the previous administration.|Baseline up to Month 6 (assessed retrospectively and prospectively at each administration [approximately 1 month apart] up to administration 8|All enrolled participants evaluable for primary objective. Here, Number of participants analyzed = participants evaluable for the outcome measure and number analyzed = participants with available data for specified category.||days||Inter-Quartile Range|Median
673248|NCT01664104|Secondary|Percentage of Participants by Number of TCZ Dose Modifications Per Participant|The number of TCZ dose modifications per participant was calculated as the number of times that the participant changed the prescribed dose with respect to the dose planned at enrollment/previous administration. If the participant did not change the prescribed dose, the values were set at missing.|Baseline up to Month 6|All enrolled participants evaluable for primary objective.||percentage of participants|||Number
673249|NCT01664104|Secondary|Number of Participants With TCZ Dose Change According to the Reason for Change|Number of participants with TCZ dose change (increase or decrease with respect to starting dose) was reported by reason for change.|Baseline up to Month 6|All enrolled participants evaluable for the primary objective and had TCZ dose modification.||participants|||Number
673250|NCT01664104|Secondary|Percentage of Participants by Duration of Morning Stiffness at Baseline|Duration of morning stiffness was defined as the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant reported the duration of morning stiffness in the case report form by ticking 1 of the following categories: no morning stiffness, less than (<) 30 minutes, 30 - 60 minutes, 60 - 120 minutes, 120 - 240 minutes, greater than (>) 240 minutes, and the whole day. 'Not estimable' represented that the participants were not able to quantify it.|Baseline|All enrolled participants evaluable for primary objective.||percentage of participants|||Number
673251|NCT01664104|Secondary|Percentage of Participants With Anti-Citrullinated Cyclic Peptide at Baseline||Baseline|All enrolled participants evaluable for primary objective with available data for this outcome measure.||percentage of participants|||Number
673252|NCT01664104|Secondary|Percentage of Participants With Positive Rheumatoid Factor (RF) at Baseline|RF is the auto antibody directed against immunoglobulin G and its concentration is observed in human serum or plasma. RF value higher than 20 units per milliliter is considered positive.|Baseline|All enrolled participants evaluable for primary objective with available data for this outcome measure.||percentage of participants|||Number
673253|NCT01664104|Secondary|Percentage of Participants With Previous RA-Related Surgical Procedures at Baseline||Baseline|All enrolled participants evaluable for primary objective with available data for this outcome measure.||percentage of participants|||Number
673254|NCT01664104|Secondary|Percentage of Participants With Evidence of Structural Joint Damage at Baseline||Baseline|All enrolled participants evaluable for primary objective with available data for this outcome measure.||percentage of participants|||Number
673255|NCT01664104|Secondary|Percentage of Participants With Presence of Extra-Articular Systemic Features of RA at Baseline|Extra-articular systemic features referred to anemia, fatigue as well as a wide range of co-morbidities such as osteoporosis and other iatrogenic complications. Percentage of participants with any of the extra-articular systemic feature are reported.|Baseline|All enrolled participants evaluable for primary objective with available data for this outcome measure.||percentage of participants|||Number
673256|NCT01664104|Secondary|C-Reactive Protein (CRP) at Baseline|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline|All enrolled participants evaluable for primary objective with available data for this outcome measure.||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
673257|NCT01664104|Secondary|Erythrocyte Sedimentation Rate (ESR) at Baseline|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeter per hour (mm/hour). A decrease in the level indicates reduction in inflammation and therefore improvement.|Baseline|All enrolled participants evaluable for primary objective with available data for this outcome measure.||mm/hour||Standard Deviation|Mean
673261|NCT01664104|Secondary|Participant Assessment of Fatigue Using VAS at Baseline|Participants measured the level of fatigue due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 mm = no fatigue to 100 mm = extreme fatigue.|Baseline|All enrolled participants evaluable for primary objective with available data for this outcome measure.||mm||Standard Deviation|Mean
673262|NCT01664104|Secondary|Participant Assessment of Morning Stiffness Using VAS at Baseline|The participant assessment of morning stiffness was measured using a ruler on a 100 mm VAS, where the responses were on a continuous range from 0 mm = no stiffness and 100 mm = maximum stiffness.|Baseline|All enrolled participants evaluable for primary objective with available data for this outcome measure.||mm||Standard Deviation|Mean
673263|NCT01664104|Secondary|Physician Global Assessment of Disease Activity (PhGH) Using VAS at Baseline|The PhGH was measured on a 100 mm VAS, where 0 mm = no arthritis activity to 100 mm = extremely active arthritis.|Baseline|All enrolled participants evaluable for primary objective with available data for this outcome measure.||mm||Standard Deviation|Mean
673264|NCT01664104|Secondary|Patient Global Assessment of Disease Activity (PGH) Using VAS at Baseline|The PGH was measured using a 100 mm VAS, where the responses were on a continuous range from 0 mm = managing very well to 100 mm = managing very poorly.|Baseline|All enrolled participants evaluable for primary objective with available data for this outcome measure.||mm||Standard Deviation|Mean
673265|NCT01664104|Secondary|Patient Assessment of Pain Using Visual Analog Scale (VAS) at Baseline|Participants measured the pain intensity due to RA on a 100 millimeter (mm) VAS, where the responses were on a continuous range from 0 mm = no pain to 100 mm = unbearable pain.|Baseline|All enrolled participants evaluable for primary objective with available data for this outcome measure.||mm||Standard Deviation|Mean
673266|NCT01664104|Secondary|Time Elapsed From Diagnosis of RA|Time elapsed from diagnosis of RA in years was calculated as the (difference between the date of enrollment visit and the date of first diagnosis of RA) divided by 365.25.|Baseline (assessed retrospectively)|All enrolled participants evaluable for primary objective with available data for this outcome measure.||years||Full Range|Median
673267|NCT01664104|Secondary|Percentage of Participants Starting TCZ After Inadequate Response (IR) to a Biologic Treatment or After Intolerance or IR to Disease-Modifying Anti-Rheumatic Drugs (DMARDs)|"Participants with at least 1 treatment with biologic agent not equal missing and which is not ongoing or with a stop date lower or equal to first TCZ administration had IR to biologic treatment. Participants with at least 1 treatment with DMARDs with a stop date lower or equal to first TCZ administration had IR to DMARDs. Participants with a biologic and DMARDs interruption or with a biologic interruption and ongoing treatment with DMARDs were classified in IR to biologic group. Participants with DMARDs interruption or ongoing DMARDs and adding TCZ without a biologic interruption were classified in the DMARDs intolerance and/or IR group."|Baseline|All enrolled participants evaluable for primary objective.||percentage of participants|||Number
673268|NCT01664104|Secondary|Percentage of Participants by TCZ Dose at Month 6|TCZ dose at Month 6 was calculated over the total number of participants evaluable for the primary objective and who did not interrupt TCZ. Percentage of participants on TCZ dose at Month 6 was calculated as the [(participants with specified TCZ dose at 6 months) divided by (participants who did not interrupt TCZ at Month 6)] multiplied by 100.|Month 6|All enrolled participants evaluable for primary objective and who did not interrupt TCZ at Month 6.||percentage of participants|||Number
673269|NCT01664104|Primary|Percentage of Participants on TCZ Treatment at Month 6|Percentage of participants on TCZ treatment at Month 6 was calculated as: [(participants on TCZ treatment at Month 6) divided by (participants evaluable for primary objective)] multiplied by 100. Confidence interval was computed based on the Clopper-Pearson method.|Month 6|All enrolled participants evaluable for primary objective.||percentage of participants||95% Confidence Interval|Number
673270|NCT01664052|Primary|Number of Occluded Fallopian Tubes 90 Days Following Placement as Measured by an HSG Evaluation|Hysterosalpingogram (HSG) is an x-ray of the uterus and fallopian tubes after the injection of a contrast material (dye). This test evaluates tubal occlusion. ESS505 and ESS505-A inserts are designed with the addition of an articulated hydrogel plug bonded to the distal portion of the insert with surgical grade adhesive and a nitinol support wire that remains inside the distal inner coil.|90 days after insert placement|||Occluded fallopian tubes|Participants||Number
673271|NCT01664052|Primary|Number of Occluded Fallopian Tubes 60 Days Following Placement as Measured by an HSG Evaluation|Hysterosalpingogram (HSG) is an x-ray of the uterus and fallopian tubes after the injection of a contrast material (dye). This test evaluates tubal occlusion. ESS505 and ESS505-A inserts are designed with the addition of an articulated hydrogel plug bonded to the distal portion of the insert with surgical grade adhesive and a nitinol support wire that remains inside the distal inner coil.|60 days after insert placement|||Occluded fallopian tubes|Participants||Number
673272|NCT01664052|Primary|Number of Occluded Fallopian Tubes 30 Days Following Placement as Measured by an HSG Evaluation|Hysterosalpingogram (HSG) is an x-ray of the uterus and fallopian tubes after the injection of a contrast material (dye). This test evaluates tubal occlusion. ESS505 and ESS505-A inserts are designed with the addition of an articulated hydrogel plug bonded to the distal portion of the insert with surgical grade adhesive and a nitinol support wire that remains inside the distal inner coil.|30 days after insert placement|||Occluded fallopian tubes|Participants||Number
673273|NCT01664052|Primary|Number of Occluded Fallopian Tubes 60 Minutes After Placement of the Insert as Measured by an HSG Evaluation|Hysterosalpingogram (HSG) is an x-ray of the uterus and fallopian tubes after the injection of a contrast material (dye). This test evaluates tubal occlusion.|60 minutes after insert placement|||Occluded fallopian tubes|Participants||Number
673274|NCT01664039|Secondary|Mean Change From Baseline In Tear Film Break Up Time (TBUT) at Month 3 and Month 6|TBUT (the time required for dry spots to appear on the corneal surface after blinking) was assessed by the investigator using slit lamp examination . A longer break up time is a sign of a more stable tear film. A positive number change from baseline indicates improvement. One eye was chosen as the study eye, and only data from the study eye were used for the analysis.|Baseline (Day 0), Month 3, Month 6|"This analysis population includes all randomized subjects who received at least 1 dose of either study treatment and had at least 1 post-baseline on therapy study visit. Here, n is the number of subjects with non-missing values at the specific time point for each arm group, respectively."||seconds||Standard Deviation|Mean
673295|NCT01663779|Primary|First Pass Success When Attempting Arterial Catheterization.|first pass success when attempting arterial catheterization of the artery|Immediate, upon study entry|||participants|||Number
673275|NCT01664039|Secondary|Mean Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Month 3 and Month 6|"The OSDI questionnaire (used to measure vision-related function, ocular symptoms, visual function, and environmental factors that may affect vision) was answered by the subject. Each of the 12 items was scored on a 0-4 Likert scale, where 0 is None of the time and 4 is All of the time. A resultant overall 0-100 score was calculated, with higher scores representing greater disability. A negative number change represents a perceived improvement in ocular health."|Baseline (Day 0), Month 3, Month 6|"This analysis population includes all randomized subjects who completed the questionnaire at baseline, received at least 1 dose of either study treatment, and had at least 1 post-baseline on-therapy study visit. Here, n is the number of subjects with non-missing values at the specific time point for each arm group, respectively."||units on a scale||Standard Deviation|Mean
673276|NCT01664039|Secondary|Number of Subjects With Change From Baseline in Conjunctiva Staining by Grade at Month 3 and Month 6|Conjunctiva staining was assessed after ophthalmic dye was instilled in the eye. The upper eyelid was lifted slightly, and the eye was compared to grading panels. Conjunctiva staining was graded on a scale from 0 (absent) to 5 (severe). One eye was chosen as the study eye, and only data from the study eye were used for the analysis.|Baseline (Day 0), Month 3, Month 6|This analysis population includes all randomized subjects who received at least 1 dose of either study treatment and had at least 1 post-baseline on therapy study visit with non-missing values by grade at the specific time point.||participants|||Number
673277|NCT01664039|Secondary|Number of Subjects With Change From Baseline in Corneal Staining by Grade at Month 3 and Month 6|Corneal staining was assessed after ophthalmic dye was instilled in the eye. The upper eyelid was lifted slightly, and the eye was compared to grading panels. Corneal staining was graded on a scale from 0 (absent) to 5 (severe). One eye was chosen as the study eye, and only data from the study eye were used for the analysis.|Baseline (Day 0), Month 3, Month 6|This analysis population includes all randomized subjects who received at least 1 dose of either study treatment and had at least 1 post-baseline on therapy study visit with non-missing values by grade at the specific time point.||participants|||Number
673278|NCT01664039|Secondary|Number of Subjects With Change From Baseline in Ocular Hyperaemia by Grade at Each Visit|Ocular Hyperaemia (excess of blood in the white of the eyes (sclera)) was graded by the investigator on a 4-point scale where 0=None/Trace, 1=Mild, 2=Moderate, and 3=Severe. One eye was chosen as the study eye, and only data from the study eye were used for the analysis.|Baseline (Day 0), Week 6, Month 3, Month 6|This analysis population includes all randomized subjects who received at least 1 dose of either study treatment and had at least 1 post-baseline on therapy study visit with non-missing values by grade at the specific time point.||participants|||Number
673279|NCT01664039|Secondary|Percentage of Subjects Who Reached Target IOP at Each Visit|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in mmHg. Target IOP was defined as ≤ 18 mmHg. One eye was chosen as the study eye, and only data from the study eye were used for the analysis.|Week 6, Month 3, Month 6|"This analysis population includes all randomized subjects who received at least 1 dose of either study treatment and had at least 1 post-baseline on therapy study visit. Here, n is the number of subjects with non-missing values at the specific time point for each arm group, respectively."||percentage of participants|||Number
673280|NCT01664039|Secondary|Mean Change From Baseline in IOP at Week 6 and Month 3|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in mmHg. A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the analysis.|Baseline (Day 0), Week 6, Month 3|"This analysis population includes all randomized subjects who received at least 1 dose of either study treatment and had at least 1 post-baseline on therapy study visit. Here, n is the number of subjects with non-missing values at the specific time point for each arm group, respectively."||mmHg||Standard Deviation|Mean
673281|NCT01664039|Primary|Mean Change From Baseline in Intraocular Pressure (IOP) at Month 6|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the analysis.|Baseline (Day 0), Month 6|"This analysis population includes all randomized subjects who received at least 1 dose of either study treatment and had at least 1 post-baseline on therapy study visit. Here, n is the number of subjects with non-missing values at the specific time point for each arm group, respectively."||mmHg||Standard Deviation|Mean
673282|NCT01663987|Secondary|Time to Event: Time to Recovery (EXACT-PRO) From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)|"Time to event: Time to recovery (EXACT-PRO) was not analysed, only Kaplan meier curve was plotted. EXACT-PRO total scores were transformed to smooth scores for determining time to recovery and all other endpoints related to the EXACT questionnaire. The day-2 score was transformed to the mean of the total scores recorded on Day 1, 2 and 3. Similarly, each subsequent day's score was transformed to the mean score using a rolling 3-day average.
This endpoint was analysed using combined data, as specified in the analysis plan."|From first drug administration to the last timepoint with information of clinical adverse outcome available, up to 2 years||||||
673283|NCT01663987|Secondary|Number of All-cause Hospitalization Event From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)|"Number of all-cause hospitalization per patient year outcome event occured during the study was analysed descriptively by calculating average occurrence (number of events per patient year drug exposure) by treatment group for on study period using the TS.
This endpoint was analysed using combined data, as specified in the analysis plan."|From first drug administration to the last timepoint with information of clinical adverse outcome available, up to 2 years|Treated set of the pooled twin studies 205.478 and 205.477||Hospitalisation per patient year|||Number
673284|NCT01663987|Secondary|Number of COPD Exacerbation Events From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)|"Number of COPD exacerbation per patient year outcome event occured during the study was analysed descriptively by calculating average occurrence (number of events per patient year drug exposure) by treatment group for on study period using the TS.
This endpoint was analysed using combined data, as specified in the analysis plan."|Start of treatment to the last timepoint with information of clinical adverse outcome available, up to 2 years|Treated set of the pooled twin studies 205.478 and 205.477||exacerbations per patient year|||Number
673296|NCT01663727|Secondary|Percentage of Participants Who Were Alive at 1 Year||1 year||||||
673285|NCT01663987|Secondary|Percentage of Patients With 30-day Readmission Rates Outcome Event From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)|"Percentage of patients with 30-day hospital readmission rates outcome events was analysed.
Days to hospital readmission were calculated as:Hospital readmission days = Readmission date - Date of hospital discharge + 1.
The 30-day hospital readmission analysis summarized the frequency of patients with hospital readmission and readmission days >1 and <31 days using the TS.
This endpoint was analysed using combined data, as specified in the analysis plan."|from date of hospital discharge prior to randomization up to readmission days >1 and <31 days|Treated set of the pooled twin studies 205.478 and 205.477||Percentage of participants|||Number
673286|NCT01663987|Secondary|Percentage of Patients With All-cause Hospitalization From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)|"Percentage of patients with all-cause hospitalization outcome event occured during the study was analysed for the combined study.
All-cause hospitalization included all hospitalizations, except planned hospitalizations for elective procedures. Hospitalizations occurring on the same day as discharge were not considered a separate admission.
This endpoint was analysed using combined data, as specified in the analysis plan."|from first drug administration to the last timepoint with information of clinical adverse outcome available, Up to 2 years|Treated set of the pooled twin studies 205.478 and 205.477||Percentage of participants|||Number
673287|NCT01663987|Secondary|Percentage of Patients With COPD Exacerbation From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)|"Percentage of patients with COPD exacerbation on study was analysed for the combined study.
A COPD exacerbation was defined as a complex of lower respiratory events/symptoms (increase or new onset) related to the underlying COPD with duration of three days or more, requiring a change in treatment where a complex of lower respiratory events/symptoms was defined as at least two of the following: 1) Shortness of breath; 2) Sputum production (volume); 3)Occurrence of purulent sputum; 4) Cough; 5) Wheezing; 6) Chest tightness. Onset of exacerbation was defined by the onset of first recorded symptom.The end of exacerbation was decided by the investigator based on clinical judgment.
A required change in treatment included either prescription of antibiotics and/or systemic steroids; and a newly prescribed maintenance respiratory medication (i.e. bronchodilators including theophyllines and PDE4-inhibitors).
This endpoint was analysed using combined data, as specified in the analysis plan."|from first drug administration to the last timepoint with information of clinical adverse outcome available, up to 2 years|Treated set of the pooled twin studies 205.478 and 205.477||Percentage of participants|||Number
673288|NCT01663987|Secondary|Change From Baseline of Trough FVC at 12 Weeks From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)|"Change from baseline of trough Forced Vital Capacity (FVC) at 12 weeks on study drug.
This endpoint was analysed using combined data, as specified in the analysis plan."|Baseline and 12 weeks|Treated set of the pooled twin studies 205.478 and 205.477||Litres||Standard Deviation|Mean
673289|NCT01663987|Secondary|Change From Baseline of Trough FEV1 at 12 Weeks on Study Drug From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)|"Change from baseline of Trough FEV1 (forced expiratory volume in one second) at 12 weeks on study drug.
Trough FEV1 is defined as the FEV1 measurement prior to the next dosing of study drug and approximately 24 hours after last inhalation of drug.
This endpoint was analysed using combined data, as specified in the analysis plan."|Baseline and 12 weeks|Treated set of the pooled twin studies 205.478 and 205.477||Litres||Standard Deviation|Mean
673290|NCT01663987|Secondary|Percentage of Patients With Adverse Clinical Event on Study|Percentage of patients with adverse clinical event during on study, which is defined as the combined endpoint of chronic obstructive pulmonary disease (COPD) exacerbations per Boehringer Ingelheim (BI) definition, all-cause re-hospitalisation, or all cause mortality.|From first drug administration to the last timepoint with information of clinical adverse outcome available, up to 2 years|Treated set||Percentage of participants|||Number
673291|NCT01663987|Secondary|Change From Baseline of Trough FVC at 12 Weeks on Study Drug|Change from baseline of trough Forced Vital Capacity (FVC) at 12 weeks on study drug.|Baseline and 12 weeks|Treated Set (TS) including patients who had trough FVC data at both baseline and week 12||Litres||Standard Deviation|Mean
673292|NCT01663987|Primary|Percentage of Patients With Next Adverse Clinical Outcome Event From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)|"Percentage of patients with next adverse clinical outcome event occured during the study, defined as the combined endpoint of chronic obstructive pulmonary disease (COPD) exacerbations per Boehringer Ingelheim (BI) definition, all-cause re-hospitalization, or all-cause mortality.
Time to the next adverse clinical outcome event from the two twin trials, was defined as a primary endpoint but was not analysed numerically, so this endpoint is presented instead.
This endpoint was analysed using combined data, as specified in the analysis plan."|From first drug administration to the last timepoint with information of clinical adverse outcome available, up to 2 years|Treated set of the pooled twin studies 205.478 and 205.477: This set includes all patients who were randomised and took at least one dose of study drug, 157 patients (79 Tiotropium and 78 placebo) were included in this set.||Percentage of perticipants|||Number
673293|NCT01663987|Primary|Change From Baseline of Trough FEV1 at 12 Weeks on Study Drug|Change from baseline in trough FEV1 (forced expiratory volume in 1 second) at 12 weeks on study medication. Trough FEV1 is defined as FEV1 measurement prior to the next dosing of study drug and approximately 24 hours after the last inhalation of drug.|Baseline and 12 weeks|Treated Set (TS) including patients who had trough FEV1 data at both baseline and week 12||Litres||Standard Deviation|Mean
673294|NCT01663922|Primary|Pharmacokinetic of Boceprevir in the Presence of Ucalm (St John's Wort)|"Pharmacokinetic parameters (maximum and trough concentrations, and area under concentratof boceprevir and SJW will be evaluated when given in combination at steady-state to evaluate possible differences in concentrations during co-administration versus drug given alone.
The pharmacokinetic parameters calculated for boceprevir and SJW will be Ctrough,the maximum observed plasma concentration (Cmax), time point at Cmax (Tmax), and total drug exposure, expressed as the area under the plasma concentration-time curve.
All pharmacokinetic parameters will be calculated using non-compartmental modelling techniques (WinNonlin®) and all statistical calculations performed within-participant changes in the assessed pharmacokinetic parameters (drug alone vs drug combination) will be evaluated by calculating geometric mean ratios."|6 months|All participants who completed the three PK assessments were included in the analysis. BCP metabolites (SCH534128 & SCH523129) PK parameters were determined in the presence and absence of SJW, and hypericin PK parameters in the presence and absence of BCP; for the total study population.||ng*h/mL||90% Confidence Interval|Geometric Mean
673297|NCT01663727|Secondary|Duration of Response - High Baseline Plasma VEGF-A ITT Population|Duration of response was defined as the time from the initial date of the objective response to documented disease progression or death (whichever occurred first). Objective response was defined as having a CR or PR according to a RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Disease progression was defined at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions. Analysis was performed using Kaplan Meier method.|Baseline, every 8 weeks until documented disease progression or clinical cut-off (up to 111.3 weeks)|Number of participants analyzed=participants from high baseline plasma VEGF-A ITT population who had an objective response.||months||95% Confidence Interval|Median
673298|NCT01663727|Secondary|Duration of Response - ITT Population|Duration of response was defined as the time from the initial date of the objective response to documented disease progression or death (whichever occurred first). Objective response was defined as having a CR or PR according to a RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Disease progression was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions. Analysis was performed using Kaplan Meier method.|Baseline, every 8 weeks until documented disease progression or clinical cut-off (up to 117.7 weeks)|Number of participants analyzed=participants from ITT population who had an objective response.||months||95% Confidence Interval|Median
673299|NCT01663727|Secondary|Percentage of Participants With an Objective Response - High Baseline Plasma VEGF-A ITT Population|Objective response was defined as having a CR or PR according to a RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Measurable disease was defined by the presence of at least one measurable lesion by clinical measurement, chest x-ray, CT, or MRI.|Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 111.3 weeks)|Number of participants analyzed=participants from high baseline plasma VEGF-A ITT population with measurable disease at baseline.||percentage of participants||95% Confidence Interval|Number
673300|NCT01663727|Primary|PFS in High Baseline Plasma VEGF-A ITT Population|PFS was defined as the interval between the date of randomization and the first documentation of progressive disease or death from any cause. Tumor assessment was performed as per RECIST v1.1 by investigator. Disease progression was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions. PFS was estimated using Kaplan Meier method.|Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 111.3 weeks)|High baseline plasma VEGF-A ITT population.||months||95% Confidence Interval|Median
673301|NCT01663727|Primary|Percentage of Participants With Progression or Death in High Baseline Plasma Vascular Endothelial Growth Factor-A (VEGF-A) ITT Population|Tumor assessment was performed as per RECIST v1.1 by investigator. Disease progression was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions.|Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 111.3 weeks)|High baseline plasma VEGF-A ITT population: All participants randomized to study treatment with high baseline plasma VEGF-A levels (VEGF-A levels greater than or equal to 5.05 picograms per milliliter), irrespective of whether the assigned treatment was actually received.||percentage of participants|||Number
673302|NCT01663727|Secondary|Percentage of Participants With an Objective Response - ITT Population|Objective response was defined as having a Complete Response (CR) or Partial Response (PR) according to a RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Measurable disease was defined by the presence of at least one measurable lesion by clinical measurement, chest x-ray, computed tomography (CT), or magnetic resonance imaging (MRI).|Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 117.7 weeks)|Number of participants analyzed=participants from ITT population with measurable disease at baseline.||percentage of participants||95% Confidence Interval|Number
673303|NCT01663727|Secondary|OS - High Baseline Plasma VEGF-A ITT Population|OS was defined as the interval between the date of randomization and death from any cause. OS was estimated using Kaplan Meier method.|From randomization till death or clinical cut-off (up to 90.9 weeks)|High Baseline Plasma VEGF-A ITT population.||months||95% Confidence Interval|Median
673304|NCT01663727|Secondary|Percentage of Participants Who Died - High Baseline Plasma VEGF-A ITT Population||From randomization till death or clinical cut-off (up to 90.9 weeks)|High Baseline Plasma VEGF-A ITT Population.||percentage of participants|||Number
673305|NCT01663727|Secondary|Overall Survival (OS) - ITT Population|OS was defined as the interval between the date of randomization and death from any cause. OS was estimated using Kaplan Meier method.|From randomization till death or clinical cut-off (up to 111.7 weeks)|ITT population.||months||95% Confidence Interval|Median
673306|NCT01663727|Secondary|Percentage of Participants Who Died - ITT Population||From randomization till death or clinical cut-off (up to 111.7 weeks)|ITT Population.||percentage of participants|||Number
673307|NCT01663727|Primary|Progression Free Survival (PFS) in ITT Population|PFS was defined as the interval between the date of randomization and the first documentation of progressive disease or death from any cause. Tumor assessment was performed as per RECIST v1.1 by investigator. Disease progression was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions. PFS was estimated using Kaplan Meier method.|Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 117.7 weeks)|ITT population.||months||95% Confidence Interval|Median
673308|NCT01663727|Primary|Percentage of Participants With Progression or Death in Intent-to-Treat (ITT) Population|Tumor assessment was performed as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by investigator. Disease progression was defined as at least 20 percent (%) increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 millimeter (mm), unequivocal progression of existing non-target lesions, or presence of new lesions.|Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 117.7 weeks)|ITT population.||percentage of participants|||Number
673309|NCT01663714|Secondary|Overall Survival|Overall survival is defined as the time from the treatment start date to the date of death from any cause.|Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.|ITT Exposed Population||months||95% Confidence Interval|Median
673310|NCT01663714|Secondary|Number of Participants Who Were Negative for Human Anti-murine Antibodies (HAMA) at Baseline (Study Entry) But Positive or Negative at Month 24|"The administration of murine antibodies may form HAMA. A HAMA assay was performed using the ImmunoSTRIP HAMA IgG enzyme-linked immune absorbent assay by a central laboratory (Covance Classic Laboratory Services, Indianapolis, IN). To be positive, a participant had to have a positive HAMA assessment during the first 24 months."|Day 1 to Day 730 (24 months) after receiving the dosimetric dose|ITT Exposed Population||participants|||Number
673311|NCT01663714|Secondary|Number of Participants Who Received Any Supportive Care|Supportive care is defined as interventions that help the participants achieve comfort but do not affect the course of a disease.|Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.|ITT-Exposed Population||participants|||Number
673312|NCT01663714|Secondary|Number of Participants With the Indicated Primary Cause of Death|The primary cause of death of the participants was assessed by the Investigator.|Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.|ITT Exposed Population. All participants who died during the study were analyzed.||participants|||Number
673313|NCT01663714|Secondary|Number of Participants With Any Treatment-related Serious Adverse Event (SAE)|An SAE is defined as any event occurring at any dose that results in any of the following outcomes: death, a life-threatening adverse drug experience (at immediate risk of death from the experience as it occurred), inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life threatening, or require hospitalization may be considered to be a serious adverse drug experience when based upon appropriate medical judgment.|Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.|ITT-Exposed Population. All participants who experienced a treatment-related SAE were analyzed.||participants|||Number
673314|NCT01663714|Secondary|Number of Participants With the Indicated Grade 3 or Grade 4 AEs Possibly or Probably Related to Study Drug|AEs were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No AE or within normal limits; 1 = Mild AE; 2 = Moderate AE; 3 = Severe and undesirable AE; 4 = Life-threatening or disabling AE; 5 = Death related to AE. The Investigator assessed whether the AE was possibly or probably related to study drug. In addition, all laboratory-derived hematologic toxicities (values outside the normal range) were assumed to be possibly or probably related to study drug.|Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.|ITT Exposed Population||participants|||Number
673315|NCT01663714|Secondary|Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events (AEs)|AEs were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No AE or within normal limits; 1 = Mild AE; 2 = Moderate AE; 3 = Severe and undesirable AE; 4 = Life-threatening or disabling AE; 5 = Death related to AE.|Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.|ITT Exposed Population||participants|||Number
673316|NCT01663714|Secondary|Nadir Values for WBC Count|Nadir is defined as the lowest laboratory value recorded up to 120 days following the therapeutic dose (or the dosimetric dose for participants who did not receive the therapeutic dose).|Up to 120 days following the therapeutic dose (given on Study Day 7, following the dosimetric dose) (or the dosimetric dose for participants who did not receive the therapeutic dose)|ITT Exposed Population||10^3 cells/µL||Full Range|Median
673317|NCT01663714|Secondary|Nadir Values for Platelet Count|Nadir is defined as the lowest laboratory value recorded up to 120 days following the therapeutic dose (or the dosimetric dose for participants who did not receive the therapeutic dose).|Up to 120 days following the therapeutic dose (given on Study Day 7, following the dosimetric dose) (or the dosimetric dose for participants who did not receive the therapeutic dose)|ITT Exposed Population||10^3 cells/microliter (µL)||Full Range|Median
674024|NCT01656252|Secondary|Phase I & Phase II- Pharmacokinetics of Eltrombopag|To determine the plasma concentrations of eltrombopag in acute myeloid leukemia patients in complete remission receiving intensive consolidation chemotherapy (selected dosing regimen only).|62 months|Data was not collected.|||||
673318|NCT01663714|Secondary|Nadir Values for Hemoglobin|Nadir is defined as the lowest laboratory value recorded up to 120 days following the therapeutic dose (or the dosimetric dose for participants who did not receive the therapeutic dose).|Up to 120 days following the therapeutic dose (given on Study Day 7, following the dosimetric dose) (or the dosimetric dose for participants who did not receive the therapeutic dose)|ITT Exposed Population||Grams/deciliter (g/dL)||Full Range|Median
673319|NCT01663714|Secondary|Nadir Values for Absolute Neutrophil Count (ANC)|Nadir is defined as the lowest laboratory value recorded up to 120 days following the therapeutic dose (or the dosimetric dose for participants who did not receive the therapeutic dose).|Up to 120 days following the therapeutic dose (given on Study Day 7, following the dosimetric dose) (or the dosimetric dose for participants who did not receive the therapeutic dose)|ITT Exposed Population||10^3 cells/cubic millimeters (mm^3)||Full Range|Median
673320|NCT01663714|Secondary|Time to Recovery (TTR) to Baseline (BL) for Hematologic Laboratory (Lab.) Evaluations|TTR to BL grade (gr.) for par. with a Gr. 0 toxicity (tox.=lab. value outside the normal range) at BL=time from the last administration of study drug (SD) to the first post-nadir (PN) date with Gr. 0 toxicity with no other Gr. 1-4 toxicities recorded within the next week. For par. with a higher gr. tox. at BL, TTR=time from the last administration of SD to the first PN date with the BL gr. or better with no other higher gr. toxicities recorded during the next week. Each lab. established its own reference range using data from its own equipment/methods; there is no standard reference range.|Up to 120 days following the therapeutic dose (given on Study Day 7, following the dosimetric dose) (or the dosimetric dose for participants who did not receive the therapeutic dose)|ITT Exposed Population. Only those participants with hematologic toxicity were evaluated for time to recovery to baseline.||days||95% Confidence Interval|Median
673321|NCT01663714|Secondary|Time to Nadir for Hematological Parameters: Absolute Neutrophil Count (ANC), Hemoglobin, Platelets, and White Blood Cell (WBC) Count|Nadir is defined as the lowest laboratory value recorded up to 120 days following the therapeutic dose (or the dosimetric dose for participants who did not receive the therapeutic dose).|Up to 120 days following the therapeutic dose (given on Study Day 7, following the dosimetric dose) (or the dosimetric dose for participants who did not receive the therapeutic dose)|ITT Exposed Population||days||Full Range|Median
673322|NCT01663714|Secondary|Total Body Residence Time (TBRT; Average Amount of Time TST Spends in the Body, Calculated From the Rate of TB Clearance of Radioactivity During the Dosimetric Dose [DD]) of Iodine 131 TST Antibody Following the DD|To determine TBRT, the percent-injected activity (PIA) is calculated from the background-corrected (BC) total body count (TBC) at D 0; D 2/3/4; and D 7. The time from the DD to the acquisition of whole body count (WBC) is then determined. The PIA remaining at each time point (TP) is then calculated by dividing the BC WBC for that TP by the BC WBC from the first TP (D 0) * 100. To determine RT, a best-fit line from 100% (pre-plotted D 0 value) through 2 plotted points (other TPs) is made. TBRT=the x-axis value at the point where the line intersects the horizontal 37% injected activity line.|Day (D) 0; D 2, 3, or 4; and D 6 or 7|ITT Exposed Population||hours||Standard Deviation|Mean
673323|NCT01663714|Secondary|Time to Treatment Failure, as Assessed by the Investigator|Time to treatment failure is defined as the time from the start of treatment to the first occurrence of study withdrawal, progression, or death.|Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.|ITT Exposed Population. If a participant did not have treatment failure, that participant was censored in the survival analysis.||months||95% Confidence Interval|Median
673324|NCT01663714|Secondary|Time to Progression of Disease or Death, as Assessed by the Investigator|Time to progression or progression-free survival is defined as the time from the dosimetric dose to the first documented occurrence of disease progression or death. Disease progression is defined as a >=50% increase from the nadir value (lowest laboratory value recorded following administration of the study medication) of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be >1.5 cm in diameter by radiographic evaluation or >1 cm in diameter by physical examination.|Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.|ITT Exposed Population. If a participant did not have progression or did not die, that participant was censored in the survival analysis.||months||95% Confidence Interval|Median
673325|NCT01663714|Secondary|DOR for Unconfirmed and Confirmed Complete Response, as Assessed by the Investigator|DOR=the time from the first documented response (for par. with CR) until disease progression (DP). DP=a >=50% increase from the nadir value (lowest laboratory value recorded following administration of study medication) of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be >1.5 centimeters (cm) in diameter by radiographic evaluation or >1 cm in diameter by physical examination. Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart.|Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.|ITT Exposed Population. Only those participants with response were analyzed. Participants who did not experience progression were censored.||months||95% Confidence Interval|Median
673326|NCT01663714|Secondary|Duration of Response (DOR), as Assessed by the Investigator|DOR=the time from the first documented response (for par. with CR, CRu, or PR) until disease progression (DP). DP=a >=50% increase from the nadir value (lowest laboratory value recorded following administration of study medication) of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be >1.5 centimeters (cm) in diameter by radiographic evaluation or >1 cm in diameter by physical examination. Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart.|Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.|ITT Exposed Population. Only those participants with response were analyzed. Participants who did not experience progression were censored.||months||95% Confidence Interval|Median
674025|NCT01656252|Primary|Phase II- Assess if Platelet Count Recovery is Increased With Eltrombopag|To determine if platelet recovery following consolidation chemotherapy is accelerated with eltrombopag.|62 months||||||
673327|NCT01663714|Secondary|Number of Participants With Confirmed Complete Response (CR), as Assessed by the Investigator|CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease, if present before therapy. Confirmed response required CR, which was confirmed by 2 separate response evaluations >=4 weeks apart.|Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.|ITT Exposed Population||participants|||Number
673328|NCT01663714|Secondary|Number of Participants With Unconfirmed Complete Response (CR), as Assessed by the Investigator|CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease, if present before therapy.|Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.|ITT Exposed Population||participants|||Number
673329|NCT01663714|Primary|Number of Participants (Par.) With Confirmed Response (Complete Response [CR], Complete Response/Unconfirmed [CRu], or Partial Response [PR]), as Assessed by the Investigator|CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. CRu: complete resolution of all disease-related symptoms; residual lymph node mass >1.5 centimeters in the greatest transverse diameter that has regressed by >75%, indeterminate bone marrow, are present. PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions. Confirmed response required CR, CRu, or PR, which were confirmed by 2 separate response evaluations >=4 weeks apart.|Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.|Intent-to-Treat (ITT) Exposed Population: all participants who were enrolled into the study and received at least one dose of study drug. Only those participants evaluable for response were analyzed.||participants|||Number
673330|NCT01663714|Primary|Number of Participants (Par.) With Unconfirmed Response (Complete Response, Complete Response/Unconfirmed, or Partial Response), as Assessed by the Investigator|Par. with response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Complete Response/unconfirmed (CRu: complete resolution of all disease-related symptoms; residual lymph node mass >1.5 centimeters in the greatest transverse diameter that has regressed by >75%, indeterminate bone marrow, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).|Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.|Intent-to-Treat (ITT) Exposed Population: all participants who were enrolled into the study and received at least one dose of study drug. Only those participants evaluable for response were analyzed.||participants|||Number
673331|NCT01663532|Secondary|Responder Rate Based on PANSS Total Score.|Responder rate was defined as ≥30% reduction from Baseline in PANSS Total Score. PANSS Total Score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Week 10|Efficacy sample was defined as the ITT population which included randomized participants who took at least one injection of double-blind (aripiprazole IM depot or placebo) and had at least one Post-Baseline efficacy assessment. LOCF was used to impute the missing data with the recorded value obtained at the preceding visit.||participants|||Number
673332|NCT01663532|Secondary|Mean Clinical Global Impression-Improvement Scale (CGI-I) Score at Endpoint.|"The severity of illness for each participants were rated using the CGI-S scale. The study physician were to answer the following question: Considering your total experience with this particular population, how mentally ill is the patient at this time? Response choices included were: 0= not assessed; 1= normal; not at all ill; 2= borderline mentally ill; 3= mildly ill; 4= moderately ill; 5= markedly ill; 6= severely ill; and 7= among the most extremely ill participants."|Week 10|Efficacy sample was defined as the ITT population which included randomized participants who took at least one injection of double-blind (aripiprazole IM depot or placebo) and had at least one Post-Baseline efficacy assessment. LOCF was used to impute the missing data with the recorded value obtained at the preceding visit.||Units on a scale||Standard Deviation|Mean
673333|NCT01663532|Secondary|Mean Change From Baseline to Endpoint in Personal and Social Performance Scale (PSP) Score.|The PSP was a validated clinician scale that measured personal and social functionining in 4 domains: socially useful activities eg, work and study), personal and social relationships, self-care, disturbing and aggressive behaviours. Impairement in each of these domains was rated as absent, mild, manifest, marked, severe, or very severe. These ratings were then converted to a total score based on a 100-point scale using algorithms to identify the appropriate 10-point interval and the study physician's judgement to determine the total score within the 10-point interval. Participants with a PSP total score of 71 to 100 were considered to have mild functional difficulty. Scores of 31 to 70 represented varying degrees of disability (31 to 70) and ratings of 1 to 30 indicated minimal functioning that required intense support and/or supervision.|Week 10|Efficacy sample included participants who took at least one injection of double-blind (aripiprazole IM depot or placebo) and had one Post-Baseline efficacy assessment. LOCF was used to impute the missing data with the recorded value obtained at the preceding visit.||Units on a scale||Standard Error|Least Squares Mean
673344|NCT01663506|Secondary|Clinical Disease Activity Index (CDAI) Score|The CDAI is the numerical sum of 4 outcome parameters: TJC28, SJC28, PtGA, and PGA. Description of these outcome parameters is given come measure 9, 10, and 18. CDAI total score = 0-76. CDAI <= 2.8 indicates disease remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high disease activity.|Baseline, Month 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.||units on a scale||Standard Deviation|Mean
673390|NCT01662999|Secondary|Mean Change From Baseline in Respiration Rate - Safety Population|Respiration rates were taken while the participant was sitting quietly for at least 5 minutes and were measured in breaths per minute (bpm). Baseline was Day -1 of Period 1; study drug was administered on Day 1 of each crossover period.|Baseline to Day 1 in each period|||bpm||Standard Deviation|Mean
673334|NCT01663532|Secondary|Mean Change From Baseline to Endpoint in PANSS Negative Subscale Score.|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicated- absence of symptoms and a score of 7 indicated- extremely severe symptoms. The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs were: blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation and stereotyped thinking. PANSS Negative Subscale Score ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms).|Baseline to Week 10|Efficacy sample was defined as the intent to treat (ITT) population which included randomized participants who took at least one injection of double-blind (aripiprazole IM depot or placebo) and had at least one Post-Baseline efficacy assessment. Data of only 162 and 167 participants from aripiprazole and placebo groups were available.||Units on a scale||Standard Error|Least Squares Mean
673335|NCT01663532|Secondary|Mean Change From Baseline to Endpoint in PANSS Positive Subscale Score.|The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. In positive subscale, the 7 positive symptom constructs were: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. PANSS Positive Subscale Score ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms).|Baseline to Week 10|Efficacy sample was defined as the intent to treat (ITT) population which included randomized participants who took at least one injection of double-blind (aripiprazole IM depot or placebo) and had at least one Post-Baseline efficacy assessment. Data of only 162 and 167 participants from aripiprazole and placebo groups were available.||Units on a scale||Standard Error|Least Squares Mean
673336|NCT01663532|Secondary|Mean Change From Baseline to Endpoint in Clinical Global Impression-Severity Scale (CGI-S) Score.|"The severity of illness for each participants were rated using the CGI-S scale. The study physician were to answer the following question: Considering your total experience with this particular population, how mentally ill is the patient at this time? Response choices included were: 0= not assessed; 1= normal; not at all ill; 2= borderline mentally ill; 3= mildly ill; 4= moderately ill; 5= markedly ill; 6= severely ill; and 7= among the most extremely ill participants."|Baseline to Week 10|Efficacy sample was defined as the intent to treat (ITT) population which included randomized participants who took at least one injection of double-blind (aripiprazole IM depot or placebo) and had at least one Post-Baseline efficacy assessment. Data of only 162 and 168 participants from aripiprazole and placebo groups were available.||Units on a scale||Standard Error|Least Squares Mean
673337|NCT01663532|Primary|Mean Change From Baseline to Endpoint in Positive and Negative Syndrome Scale (PANSS) Total Score.|The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 that indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. The PANSS total score was the sum of the rating scores for 7 positive subscale items, 7 negative subscale items, and 16 general psychopathology subscale items from the PANSS panel. PANSS Total Score ranged from 30 (best possible outcome) to 210 (worst possible outcome). The primary statistical comparison was performed using the Mixed Model Repeated Measure (MMRM) approach.|Baseline to Week 10|Efficacy sample was defined as the intent to treat (ITT) population which included randomized participants who took at least one injection of double-blind (aripiprazole IM depot or placebo) and had at least one Post-Baseline efficacy assessment. Data of only 162 and 167 participants from aripiprazole and placebo groups were available.||Units on a scale||Standard Error|Least Squares Mean
673338|NCT01663506|Secondary|Number of Participants With Disease Activity Status Based on CDAI Score|Participants were assigned the disease activity status on the basis of CDAI score. Description of CDAI score calculation is provided in Outcome Measure 20. Remission: CDAI score <= 2.8; low disease activity: CDAI <=10.0; moderate disease activity: CDAI <=22.0; and high disease activity: CDAI >22.0.|Baseline, Month 3, 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category.||participants|||Number
673339|NCT01663506|Secondary|Number of Participants With Disease Activity Status Based on SDAI Score|Participants were assigned the disease activity status on the basis of SDAI score. Description of SDAI score calculation is provided in Outcome Measure 19. Remission: SDAI score <= 3.3; low disease activity: SDAI <=11.0; moderate disease activity: SDAI <=26.0; and high disease activity: SDAI >26.0.|Baseline, Month 3, 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category.||participants|||Number
673340|NCT01663506|Secondary|Number of Participants With Disease Activity Status Based on DAS28 Score|Participants were assigned the disease activity status on the basis of DAS28 score. Description of DAS28 calculation is provided in Outcome Measure 7. Remission: DAS28 score <= 2.6; low disease activity: DAS28 <=3.2; moderate disease activity: DAS28 <=5.1; and high disease activity: DAS28 >5.1.|Baseline, Month 3, 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category.||participants|||Number
673341|NCT01663506|Secondary|Number of Participants Receiving Oral Corticosteroids||Baseline, Month 3, 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.||participants|||Number
673342|NCT01663506|Secondary|Number of Participants Who Received Tocilizumab in Combination With Disease Modifying Anti-rheumatic Drugs (DMARDs)||Baseline, Study end (at Month 12 or at time of study discontinuation)|FAS.||participants|||Number
673343|NCT01663506|Secondary|Number of Participants Who Received Tocilizumab as Monotherapy||Baseline, Study end (at Month 12 or at time of study discontinuation)|FAS.||participants|||Number
673374|NCT01663233|Secondary|Change in Mean Sitting Diastolic Blood Pressure (msDBP)|The change in the patient's msDBP from baseline to end of the study was measured. A reduction from baseline indicates a positive treatment effect.|8 weeks|FAS||mmHg||Standard Error|Least Squares Mean
674110|NCT01654276|Primary|Fractional Excretion UA||6 months|||mg/mg||Standard Deviation|Mean
674111|NCT01654276|Primary|Urine Creatinine||6 months|||mg/dl||Standard Deviation|Mean
673345|NCT01663506|Secondary|Simplified Disease Activity Index (SDAI) Score|The SDAI is the numerical sum of five outcome parameters: TJC28, SJC28, PtGA, PGA, and CRP. Description of these outcome parameters is given in outcome measure 9, 10, 16, and 18. SDAI total score = 0-86. SDAI <=3.3 indicates disease remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity.|Baseline, Month 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.||units on a scale||Standard Deviation|Mean
673346|NCT01663506|Secondary|Number of Swollen and Tender Joints Based on 28 Joints|Number of swollen joints was determined by examination of 28 (SJC28) joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, 0 = no swelling, 1 = swelling. Number of tender joints was determined by examining 28 joints (TJC28) and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, 0 = no tenderness, 1 = tenderness.|Baseline, Month 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point for specified category.||joints count||Standard Deviation|Mean
673347|NCT01663506|Secondary|Number of Swollen and Tender Joints Based on 66 and 68 Joints|Number of swollen joints was determined by examination of 66 joints (SJC66) and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, 0 = no swelling, 1 = swelling. Number of tender joints was determined by examining 68 joints (TJC68) and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, 0 = no tenderness, 1 = tenderness.|Baseline, Month 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point for specified category.||joints count||Standard Deviation|Mean
673348|NCT01663506|Secondary|C-Reactive Protein (CRP)|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range is up to 10 milligram per liter (mg/L). A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Month 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.||mg/L||Standard Deviation|Mean
673349|NCT01663506|Secondary|Erythrocyte Sedimentation Rate (ESR)|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.|Baseline, Month 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.||mm/hr||Standard Deviation|Mean
673350|NCT01663506|Secondary|Visual Analog Scale-Morning Stiffness (VAS-MS)|Participants assessed their morning stiffness using a 0 - 100 mm VAS, where 0 mm = no stiffness and 100 mm = worst possible stiffness.|Baseline, Month 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.||mm||Standard Deviation|Mean
673351|NCT01663506|Secondary|Visual Analog Fatigue Scale (VAFS)|Participants assessed their fatigue using a 0 - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue.|Baseline, Month 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.||mm||Standard Deviation|Mean
673352|NCT01663506|Secondary|Visual Analog Scale (VAS)-Pain|Intensity of pain was measured on a 100 mm line VAS marked by participant. It ranged (over the past week): 0 = no pain to 100 = worst possible pain.|Baseline, Month 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.||mm||Standard Deviation|Mean
673353|NCT01663506|Secondary|Health Assessment Questionnaire-Disability Index (HAQ-DI) Score|HAQ-DI: participant reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item was scored on a 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores divided by the number of domains answered. Total possible score range was 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Month 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.||units on a scale||Standard Deviation|Mean
673354|NCT01663506|Secondary|Patient Global Assessment (PtGA) of Disease Activity Score|PtGA of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity and 100 mm = highest possible disease activity.|Baseline, Month 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.||mm||Standard Deviation|Mean
673355|NCT01663506|Secondary|Physician Global Assessment (PGA) of Disease Activity|PGA of disease activity was measured on a 0 to 100 millimeter (mm) visual analog scale (VAS), with 0 mm = no disease activity and 100 mm = highest possible disease activity.|Baseline, Month 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.||mm||Standard Deviation|Mean
673375|NCT01663233|Secondary|Change in Mean Sitting Systolic Blood Pressure (msSBP)|The change in the patient's msSBP from baseline to end of the study was measured. A reduction from baseline indicates a positive treatment effect.|8 weeks|FAS||mmHg||Standard Error|Least Squares Mean
673389|NCT01662999|Secondary|Mean Change From Baseline in Temperature - Safety Population|Participant had their temperature taken after quietly sitting for at least 5 minutes and it was measured as degrees of centigrade (C). Baseline was Day -1 of Period 1; study drug was administered on Day 1 of each crossover period.|Baseline to Day 1 in each period|Safety Population = All participants who received at least one dose of any study drug.||degrees of centigrade||Standard Deviation|Mean
673356|NCT01663506|Secondary|Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28|The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Description of DAS28 calculation is provided in Outcome Measure 7. Good responders: decrease from baseline >1.2 with DAS28 <= 3.2; moderate responders: decrease from baseline >1.2 with DAS28 >3.2 or decrease from baseline >0.6 to <=1.2 with DAS28 <=5.1; non-responders: decrease from baseline <= 0.6 or decrease from baseline >0.6 and <=1.2 with DAS28 >5.1.|Month 3, 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category.||participants|||Number
673357|NCT01663506|Secondary|Disease Activity Score Based on 28-joints Count (DAS28)|DAS28 calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and patient's global assessment (PtGA) of disease activity. DAS28 total score range = 0 to 10, where higher scores indicates higher disease activity. DAS28 less than and equal to (<=) 2.6 meant clinical remission; DAS28 <=3.2 meant low disease activity; DAS28 greater than (>) 3.2 to 5.1 implied moderate disease activity; and DAS28 >5.1 implied high disease activity.|Baseline, Month 3, 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.||units on a scale||Standard Deviation|Mean
673358|NCT01663506|Secondary|Number of Participants With Prior Exposure of Biologics||Baseline|FAS.||participants|||Number
673359|NCT01663506|Secondary|Number of Participants With Prior Exposure to Disease Modifying Anti-rheumatic Drugs (DMARDs)||Baseline|FAS.||participants|||Number
673360|NCT01663506|Secondary|Number of Participants With Comorbidities at Baseline|Participants were assessed for any comorbidity at study entry including anemia, fatigue, conventional risk factors for cardiovascular disease, C-reactive protein (CRP) level above upper limit of normal, rheumatoid nodules, rheumatoid vasculitis, interstitial lung disease, and so on. Number of participants with each comorbidity was reported. One participant could have presented with more than 1 comorbidity.|Baseline|FAS.||participants|||Number
673361|NCT01663506|Secondary|Percentage of Participants With Tocilizumab Dose Modification, Interruption, and Irregularity|Dose modification was defined as an increase or decrease in the dose of study drug compared to the previous dose received. Interruption was defined as temporary or permanent discontinuation of study drug due to any reason, for example adverse event. Irregularity was defined as a time interval of greater than and equal to (>=) 75 days between two consecutive doses of study drug.|Up to Month 12|FAS.||percentage of participants|||Number
673362|NCT01663506|Secondary|Percentage of Participants With Tocilizumab Treatment at 12 Months After Treatment Initiation||Month 12|FAS.||percentage of participants||95% Confidence Interval|Number
673363|NCT01663506|Primary|Percentage of Participants With Tocilizumab Treatment at 6 Months After Treatment Initiation||6 Months|FAS.||percentage of participants||95% Confidence Interval|Number
673364|NCT01663363|Secondary|Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better||6 Months|Percentage of eyes with UCVA of 20/40 or better. Target for this outcome measure is greater than 85% achieving UCVA of 20/40 or Better. Data from 334 eyes of 170 participants are included for the outcome measure “Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better“.||percentage of eyes|Participants|95% Confidence Interval|Number
673365|NCT01663363|Primary|Percentage of Eyes With Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA)||6 Months|"Data from 334 eyes of 170 participants are included for the outcome measure Percentage of Eyes With Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA)."||percentage of eyes|Participants|95% Confidence Interval|Number
673366|NCT01663285|Secondary|Number of Participants With Adverse Events|The safety of neoadjuvant chemotherapy.|9 years|Due to poor patient enrollment this outcome was not able to be analyzed.|||||
673367|NCT01663285|Secondary|Number of Patients With Pathologic T0/Tis/Ta N0.|The proportion of patients with pathologic T0/Tis/Ta N0.|51 months|Due to poor patient enrollment this outcome was not able to be analyzed.|||||
673368|NCT01663285|Primary|Recurrence-free Survival Time|The 2-year recurrence-free survival (RFS) time for patients treated with neoadjuvant cisplatin and gemcitabine chemotherapy followed by surgery in high risk upper tract urothelial carcinoma.|2 years after participant surgery|Due to poor patient enrollment the primary objective was not able to be analyzed.|||||
673369|NCT01663233|Secondary|Number of Participants With Adverse Event|Participants were monitored for adverse events, serious adverse events and death.|8 weeks|Safety Set: The safety set included all randomized participants who received at least one dose of study medication.||Participants|||Number
673370|NCT01663233|Secondary|Number of Participants Achieving Successful Response in msDBP (< 90 mmHg or a Reduction ≥ 10 mmHg From Baseline)|The number of participants who achieved successful treatment response in msDBP of < 90mmHg or a reduction ≥ 10mmHg from baseline after completing study treatment was measured. Participants who achieved either of the above targets were deemed as having a successful response.|8 weeks of treatment|FAS||Participants|||Number
673371|NCT01663233|Secondary|Number of Participants Achieving Successful Response in msSBP (< 140 mmHg or a Reduction ≥ 20 mmHg From Baseline)|The number of participants who achieved successful treatment response in the msSBP of < 140mmHg or a reduction ≥ 20 mmHg from baseline after completing study treatment was measured. Participants who achieved either of the above targets were deemed as a having a successful response.|8 weeks|FAS||Participants|||Number
673372|NCT01663233|Secondary|Number of Participants Achieving Systolic and Diastolic Blood Pressure Control (< 140/90 mmHg)|The number of participants achieving a systolic and diastolic blood pressure < 140/90 mmHg was measured. This outcome measure shows how well a given blood pressure treatment can achieve a given blood pressure target or goal. Participants who achieved the target blood pressure were determined based on the mean SBP and DBP measurements taken at the end of the study. If the participants' BP measurement was below the above target, they were considered to have successful blood pressure control.|8 weeks|FAS||Participants|||Number
673373|NCT01663233|Secondary|Change in Sitting Pulse Pressure (PP)|The change in the patient's mean sitting PP from baseline to end of the study was measured. Pulse pressure measures the difference in mean sitting systolic blood pressure and mean sitting diastolic blood pressure.|8 weeks|FAS||mmHg||Standard Error|Least Squares Mean
673376|NCT01663233|Secondary|Change in Mean 24-hour ABPM Diastolic Blood Pressure (maDBP)|The change in mean 24 hour maDBP from baseline to end of the study was measured. A reduction from baseline indicates a positive treatment effect.|8 weeks|FAS: This set included all randomized participants who received at least one dose of study medication. Among the 266 Full Analysis Set (FAS) participants, 251 participants (123 participants in the LCZ696 + amlodipine group and 128 participants in the amlodipine group) had eligible ABPM at both baseline and endpoint.||mmHg||Standard Error|Least Squares Mean
673377|NCT01663233|Primary|Change in Mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (maSBP)|The change in mean 24 hour ambulatory systolic blood pressure (maSBP) from baseline to end of the study (week 8) in the 2 groups was measured. A greater reduction from baseline in the LCZ696 group indicates a positive treatment effect.|8 weeks|FAS: This set included all randomized participants who received at least one dose of study medication. Among the 266 Full Analysis Set (FAS) participants, 251 participants (123 participants in the LCZ696 + amlodipine group and 128 participants in the amlodipine group) had eligible ABPM at both baseline and endpoint.||mmHg||Standard Error|Least Squares Mean
673378|NCT01663103|Other Pre-specified|Change in Vascular Endothelial NADPH Oxidase Expression|Vascular endothelial cells will be collected and assessed for changes in protein expression of NADPH oxidase after 3 months of treatment with rilonacept vs. placebo. Protein expression is calculated as a ratio of intensity of staining in the patient cells relative to human umbilical vein endothelial cell (HUVEC) control cells. The absolute change in this ratio between baseline and week 12 is reported below.|3 months after start of treatment|sub-group from Denver site||absolute change in ratio||Standard Deviation|Mean
673379|NCT01663103|Other Pre-specified|Change in High-sensitivity C-reactive Protein (hsCRP)|Change in high-sensitivity C-reactive protein (hsCRP) after 3 months of rilonacept vs. placebo will be assessed as a circulating marker of inflammation.|3 months after start of treatment|||change in c-reactive protein (mg/L)||Inter-Quartile Range|Median
673380|NCT01663103|Secondary|Change in Contribution of Oxidative Stress to FMD|FMD will be assessed following acute infusion of ascorbic acid compared to saline. The improvement in FMD with ascorbic acid reflects the degree of oxidative stress contributing to impairment in FMD.|3 months after start of treatment|sub-group from Denver site||change in percent flow-mediated dilation||Standard Deviation|Mean
673381|NCT01663103|Secondary|Change in Aortic Pulse-wave Velocity (aPWV)|Change in aPWV after 3 months of treatment with rilonacept will be compared to change in the placebo group.|3 months after start of treatment|||change in pulse-wave velocity (cm/sec)||Standard Deviation|Mean
673382|NCT01663103|Primary|Change in Flow-mediated Dilation (FMD)|Change in FMD after 3 months of treatment with rilonacept will be compared to change in the placebo group.|3 months after start of treatment|||change in percent flow-mediated dilation||Standard Deviation|Mean
673383|NCT01663012|Secondary|Overall Survival From Time of Diagnosis|Will be described using Kaplan-Meier estimates.|From date of pathologic diagnosis/confirmation of high grade glioma to date of death, assessed up to 2 years.|||Months||95% Confidence Interval|Median
673384|NCT01663012|Secondary|Survival From the Time of First NKTR-102 Dose for Patients With BEV-resistant Glioma Receiving NKTR-102 to Date of Death|Will be described using Kaplan-Meier estimates.|From date of first dose of NKTR-102 to date of death, assessed up to 2 years|||Months||95% Confidence Interval|Median
673385|NCT01663012|Primary|Progression Free Survival, Assessed by Revised Assessment in Neuro-oncology (RANO) Criteria|Will be described using Kaplan-Meier estimates. The PFS probability at 6 weeks (PFS-6week) will be estimated with an 80% power and 95% confidence intervals (80% in accord with the planned alpha level, 95% for comparability with other studies, confidence intervals based on the Greenwood formula for the variance of a survival probability).|6 weeks from first administration of NKTR-102|||participants|||Number
673386|NCT01662999|Secondary|Number of Participants With Change From Baseline in ECG Interval - Safety Population|A 12-Lead electrocardiogram (ECG) was performed and recorded after the participant had been supine for at least 5 minutes. ECGs done at baseline (Day-1 of Period 1) and at end of study; therefore the results are presented by sequence, and cannot be presented by treatment. QT interval (measure between Q wave and T wave in the heart's electrical cycle); and QT interval corrected for heart rate using Fridericia's formula (QTcF) were measured in milliseconds (msec). Abnormality criteria: QT/QTcF QT or QTcF >450 msec and <=480 msec at any postdose time point and not present at baseline. QT or QTcF >480 msec and <=500 msec at any postdose time point and not present at baseline QT or QTcF >500 msec at any postdose time point and not present at baseline. QT/QTcF Increase from baseline >60 msec for at least 1 postdose measurement. Increase from baseline in QT or QTcF >30 msec for at least 1 postdose measurement, but <=60 msec for all postdose measurements.|Baseline to end of study (16 days)|Safety Population = All participants who received at least one dose of any study drug.||participants|||Number
673387|NCT01662999|Secondary|Number of Participants With Marked Urinalysis Laboratory Abnormalities - Safety Population|Baseline was Day -1 of Period 1; study drug was administered on Day 1 of each crossover period. Fasted for 10 hours prior to samples taken. LLN=lower limit of normal; ULN=upper limit of normal; pretreatment (Pre-Rx). Normals: Urine glucose qualitative: dipstick >=1 if Pre-Rx <1 or 2*Pre-Rx if Pre-Rx>=1; urine microscopic white blood cell count (WBC): >=2 if Pre-Rx <2 or >=4 if Pre-Rx >=2;urine red blood cell count (RBC):>=2 if Pre-Rx <2 or >=4 if Pre-Rx >=2.|Baseline to Day 1 of each period|Safety Population = All participants who received at least one dose of any study drug. Urine WBC and RBC were not done for all 42 participants. Number of participants analyzed (N) for the 3 treatments for WBC/RBC urine were 4, 8, 6, in treatment A, B, C, respectively.||participants|||Number
673388|NCT01662999|Secondary|Number of Participants With Marked Chemistry Laboratory Abnormalities - Safety Population|Fasted for 10 hours prior to samples taken. Baseline was Day -1 of Period 1; study drug was administered on Day 1 of each crossover period. Lower limit of normal(LLN); upper limit of normal (ULN); pre-treatment(Pre-Rx). Alkaline phosphatase U/L:>1.25*Pre-RX if Pre-Rx >ULN or >1.25*ULN if Pre-Rx <=ULN; aspartate aminotransferase (AST) U/L: >1.25*Pre-Rx if Pre-Rx > ULN or 1.25*ULN if Pre-Rx <= ULN;alanine aminotransferase (ALT) U/L: >1.25*Pre-Rx if Pre-Rx>ULN or 1.25*ULN if Pre-Rx<=ULN;blood urea nitrogen (BUN)mmol/L: >1.1*ULN if Pre-Rx <=ULN or >1.2*Pre-Rx if Pre-Rx >ULN; total bilirubin µmol/L: >1.1*ULN if Pre-Rx <=ULN or >1.25*Pre-Rx if Pre-Rx >ULN;direct bilirubin µmol/L: >1.1*ULN if Pre-Rx <= ULN or >1.25*Pre-Rx if Pre-Rx > ULN; creatine phosphokinase (CK) U/L: >1.5*Pre-Rx if Pre-Rx >ULN or >1.5*ULN if Pre-Rx <= ULN.|Baseline to Day 1 in each period|Safety Population = All participants who received at least one dose of any study drug.||participants|||Number
674112|NCT01654276|Primary|Urine Uric Acid||6 months|||mg/dl||Standard Deviation|Mean
673391|NCT01662999|Secondary|Mean Change From Baseline in Heart Rate - Safety Population|Heart rates were taken while the participant was sitting quietly for at least 5 minutes and were measured in beats per minute (bpm). Baseline was Day -1 of Period 1; study drug was administered on Day 1 of each crossover period.|Baseline to Day 1 in each period|Safety Population = All participants who received at least one dose of any study drug.||bpm||Standard Deviation|Mean
673392|NCT01662999|Secondary|Mean Change From Baseline in Systolic and Diastolic Blood Pressure - Safety Population|Blood pressure was taken while the participant was quietly seated for at least 5 minutes. Blood pressure was measured in millimeters of mercury (mmHg). Baseline was Day -1 in Period 1; study drug was administered on Day 1 of each crossover period.|Baseline to Day 1 of each period|Safety Population = All participants who received at least one dose of any study drug.||mmHg||Standard Deviation|Mean
673393|NCT01662999|Secondary|Number of Participants With Marked Hematology Laboratory Abnormalities - Safety Population|Fasted for 10 hours prior to samples taken. Baseline was Day -1 of Period 1; study drug was administered on Day 1 of each crossover period. Lower limit of normal (LLN); upper limit of normal (ULN); pretreatment(pre-RX); treatment (RX). Hemoglobin (g/L): <0.85* pre-RX; hematocrit (vol): <0.85*pre-RX; erythrocytes (*10^12 c/L): <0.85*pre-RX; platelet count (*10^9 c/L): <0.85*LLN if pre-RX>=LLN, or if Pre-Tx <LLN; leukocytes (*10^9 c/L): <0.85*LLN if pre-RX <LLN,or <0.9*LLN if LLN<=Pre-RX<=ULN; neutrophils+bands (*10^9 c/L): <0.85*Pre-RX if Pre-RX <1.5 or <1.5 if Pre-RX >=1.5; eosinophils (*10^9 c/L): if value >0.75; basophils (*10^9 c/L): if value >0.4; monocytes (*10^9c/L): if value >2; lymphocytes (*10^9 c/L): if value <0.750 or if value >7.50.|Baseline to Day 1 of each period|Safety Population = All participants who received at least one dose of any study drug.||participants|||Number
673394|NCT01662999|Secondary|Number of Participants With Deaths, Serious Adverse Events, Adverse Events, or Discontinuations Due to Adverse Events - Safety Population|Adverse event (AE)=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Serious adverse event (SAE)=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. End of study was approximately 16 days and was the time for a participant to conclude each of the 3 periods (including the 6 day washout between periods).|Day 1 to end of study (16 days)|Safety Population = All participants who received at least one dose of any study drug.||participants|||Number
673395|NCT01662999|Secondary|Metabolite to Parent Molar Ratios (MR) of Cmax, AUC(INF), and AUC(0-T) of 5-OH Saxagliptin and Saxagliptin From a Single Dose 5 mg Saxagliptin Versus MR of Saxagliptin and 5-OH When Saxagliptin Was Co-administered With 10 mg Dapagliflozin - PK Evaluable|Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Saxagliptin is the parent drug and 5-OH saxagliptin is the metabolite. The molecular weights to be used for the molar ratios were 315.42 and 331.42 for saxagliptin and 5-OH, respectively. Plasma samples were analyzed for saxagliptin and for 5-OH by LC-MS/MS using a validated method (quantitation range of 0.100 ng/mL to 50.0 ng/mL and 0.200 ng/mL to 100.0 ng/mL for saxagliptin and 5-OH, respectively).|Day 1 (0h to 60h post dose) in each period|PK Evaluable Population: All participants who received at least 1 dose of any study drug and had at least 1 valid PK parameter for at least 1 analyte.||Molar ratio||Geometric Coefficient of Variation|Geometric Mean
673396|NCT01662999|Secondary|Half-life (T-HALF) of Saxagliptin, and 5-OH Saxagliptin From Single Dose 5 mg Saxagliptin Versus T-HALF of Saxagliptin and 5-OH From Co-administered Saxagliptin With 10 mg Dapagliflozin - PK Evaluable Population|Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Plasma samples were analyzed for saxagliptin by LC-MS/MS using a validated method. T-HALF was derived from the plasma concentration versus time profile using a validated PK analysis program ™ and was measured in hours (h).|Day 1 (0h to 60h post dose) in each period|PK Evaluable Population: All participants who received at least 1 dose of any study drug and had at least 1 valid PK parameter for at least 1 analyte.||h||Standard Deviation|Mean
673397|NCT01662999|Secondary|Tmax of Saxagliptin, 5-OH Saxagliptin, Saxagliptin Total Active Moiety From a Single Dose of Saxagliptin Versus Tmax of Saxagliptin, 5-OH, Saxagliptin Total Active Moiety When Saxagliptin Was Co-administered With Dapagliflozin - PK Evaluable Population|Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Plasma samples were analyzed for saxagliptin and 5-OH by LC-MS/MS using a validated method. Tmax was derived from the plasma concentration versus time profile for study drug and was measured in hours (h). Saxagliptin was the drug, 5-OH saxagliptin was the metabolite, and Saxagliptin total Active Moiety was molar summations of saxagliptin exposure parameter with one-half the molar exposure parameters for 5-OH Saxagliptin.|Day 1 (0h to 60h post dose) in each period|PK Evaluable Population: All participants who received at least 1 dose of any study drug and had at least 1 valid PK parameter for at least 1 analyte.||h||Full Range|Median
673398|NCT01662999|Secondary|AUC(INF) and AUC(0-T) of the Saxagliptin Total Active Moiety From a Single Dose 5 mg Saxagliptin Versus AUC(INF) and AUC(0-T) of Saxagliptin Total Active Moiety When Saxagliptin Was Co-administered With 10 mg Dapagliflozin - PK Evaluable Population|Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Plasma samples were analyzed for saxagliptin by LC-MS/MS using a validated method. AUC(INF) is area under the plasma concentration-time curve from time zero extrapolated to infinity; AUC(0-T) is area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (linear up/log down trapezoidal method) and both were derived from the plasma concentration versus time profile using a validated PK analysis program ™. Total moiety (molar summations of saxagliptin exposure parameter with one-half the molar exposure parameters for 5-OH Saxagliptin), AUC(0-T)and AUC(INF) were measured in nano Molars*hours (nM*h).|Day 1 (0h to 60h post dose) in each period|PK Evaluable Population: All participants who received at least 1 dose of any study drug and had at least 1 valid PK parameter for at least 1 analyte.||nM*h||Geometric Coefficient of Variation|Geometric Mean
674113|NCT01654276|Primary|Serum Triglycerides||6 months|||mg/dl||Standard Deviation|Mean
673399|NCT01662999|Secondary|Cmax of the Saxagliptin Total Active Moiety From a Single Dose of 5 mg Saxagliptin Versus Cmax of Saxagliptin Total Active Moiety When Saxagliptin Was Co-administered With 10 mg Dapagliflozin - PK Evaluable Population|Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Cmax of saxagliptin total active moiety (molar summations of saxagliptin exposure parameter with one-half the molar exposure parameters for 5-OH Saxagliptin) was derived from the plasma concentration versus time profile for the saxagliptin total active moiety. Measurement was in nano Molars (nM).|Day 1 (0h to 60h post dose) in each period|PK Evaluable Population: All participants who received at least 1 dose of any study drug and had at least 1 valid PK parameter for at least 1 analyte.||nM||Geometric Coefficient of Variation|Geometric Mean
673400|NCT01662999|Secondary|AUC(INF) of 5-OH Saxagliptin From a Single Dose Saxagliptin Versus AUC(INF) of 5-OH When Saxagliptin Was Co-administered With Dapagliflozin - PK Evaluable Population|Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Plasma samples were analyzed for 5-OH by LC-MS/MS using a validated method (quantitation range of 0.200 ng/mL to 100.0 ng/mL). AUC(INF) was derived from the plasma concentration versus time profile using a validated PK analysis program ™ and was measured in nanograms*hours per milliliter (ng*h/mL).|Day 1 (0h to 60h post dose) in each period|PK Evaluable Population: All participants who received at least 1 dose of any study drug and had at least 1 valid PK parameter for at least 1 analyte.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
673401|NCT01662999|Secondary|AUC(0-T) of 5-OH Saxagliptin From Single Dose Saxagliptin Versus AUC(0-T) of 5-OH From Saxagliptin Co-administered With Dapagliflozin - PK Evaluable Population|Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Plasma samples were analyzed for 5-OH by LC-MS/MS using a validated method (quantitation range of 0.200 ng/mL to 100.0 ng/mL). AUC(0-T) is area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (linear up/log down trapezoidal method)and was derived from the plasma concentration versus time profile for study drug using a validated PK analysis program ™. AUC (0-T) was measured in nanograms*hours per milliliter (ng*h/mL).|Day 1 (0h to 60h post dose) in each period|PK Evaluable Population: All participants who received at least 1 dose of any study drug and had at least 1 valid PK parameter for at least 1 analyte.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
673402|NCT01662999|Primary|AUC(INF) of Saxagliptin From a Single Dose of 5 mg Saxagliptin Versus AUC(INF) of Saxagliptin When Co-administered With 10 mg Dapagliflozin - PK Evaluable Population|Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Plasma samples were analyzed for saxagliptin by LC-MS/MS using a validated method (quantitation range of 0.100 ng/mL to 50.0 ng/mL). AUC(INF) was derived from the plasma concentration versus time profile using a validated PK analysis program ™ and was measured in nanograms*hours per milliliter (ng*h/mL).|Day 1 (0h to 60h post dose) in each period|PK Evaluable Population: All participants who received at least 1 dose of any study drug and had at least 1 valid PK parameter for at least 1 analyte.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
673403|NCT01662999|Primary|AUC(0-T) of Saxagliptin From Single Dose 5 mg Saxagliptin Versus AUC(0-T) of Saxagliptin When Co-administered With 10 mg Dapagliflozin - PK Evaluable Population|Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Plasma samples were analyzed for saxagliptin by Liquid chromatography–Mass Spectrometry (LC-MS/MS) using a validated method (quantitation range of 0.100 ng/mL to 50.0 ng/mL). AUC(0-T), the area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (linear up/log down trapezoidal method) was derived from the plasma concentration versus time profile for study drug using a validated PK analysis program ™ and was measured in nanograms*hours per milliliter (ng*h/mL).|Day 1 (0h to 60h post dose) in each period|PK Evaluable Population: All participants who received at least 1 dose of any study drug and had at least 1 valid PK parameter for at least 1 analyte.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
673404|NCT01662999|Secondary|Cmax of 5-Hydroxy (5-OH) Saxagliptin From a Single Dose Saxagliptin Versus Cmax of 5-OH When Saxagliptin Was Co-administered With Dapagliflozin - PK Evaluable Population|Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Plasma samples were analyzed for 5-OH by LC-MS/MS using a validated method (quantitation range of 0.200 ng/mL to 100.0 ng/mL). Actual sampling times were used for PK calculations. Cmax for 5-OH Saxagliptin (the major active metabolite of Saxagliptin) was derived from plasma concentration versus time data using a validated PK analysis program ™ and was measured in ng/mL.|Day 1 (0h to 60h post dose) in each period|PK Evaluable Population: All participants who received at least 1 dose of any study drug and had at least 1 valid PK parameter for at least 1 analyte.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
673405|NCT01662999|Secondary|Plasma Apparent Clearance (CLT/F) of a Single Dose of Dapagliflozin Versus CLT/F of Dapagliflozin When Co-administered With Saxagliptin - PK Evaluable Population|Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Plasma samples were analyzed for dapagliflozin by HPLC-MS/MS using a validated method. Actual sampling times were used for PK calculations. CLT/F was calculated as Dose/AUC(INF)and was measured in milliliters per minute (mL/min).|Day 1 (0h to 60h post dose) in each period|PK Evaluable Population: All participants who received at least 1 dose of any study drug and had at least 1 valid PK parameter for at least 1 analyte. One participant in the ACB treatment sequence withdrew consent after having received all 3 treatments; this participant did not provide 36-, 48-, or 60-hour samples in Period 3 (Treatment B).||mL/min||Geometric Coefficient of Variation|Geometric Mean
673421|NCT01662986|Secondary|Change From Baseline of Trough FVC at 12 Weeks From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987)|Change from baseline of trough Forced Vital Capacity (FVC) at 12 weeks on study drug.|Baseline and week 12|Treated Set of the pooled twin studies 205.478 and 205.477. The number of patients analyzed at week 12 from the treated set were 59 for Placebo and 60 for Tiotropium.||Litres||Standard Deviation|Mean
673406|NCT01662999|Primary|Maximum Observed Concentration (Cmax) of a Single Dose of 5 mg Saxagliptin Versus Cmax of Saxagliptin When Co-administered With 10 mg Dapagliflozin - PK Evaluable Population|Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Plasma samples were analyzed for saxagliptin by Liquid chromatography–Mass Spectrometry (LC-MS/MS) using a validated method (quantitation range of 0.100 ng/mL to 50.0 ng/mL). Cmax for Saxagliptin was derived from plasma concentration versus time data using a validated PK analysis program ™ and was measured in nanograms per milliliter (ng/mL).|Day 1 (0h to 60h post dose) in each period|PK Evaluable Population: All participants who received at least 1 dose of any study drug and had at least 1 valid PK parameter for at least 1 analyte.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
673407|NCT01662999|Secondary|Half-life (T-HALF) of Dapagliflozin From a Single Dose of Dapagliflozin Versus T-Half of Dapagliflozin When Co-administered With Saxagliptin - PK Evaluable Population|Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Plasma samples were analyzed for dapagliflozin by HPLC-MS/MS using a validated method. Actual sampling times were used for PK calculations. T-HALF was derived from the plasma concentration versus time profile using a validated PK analysis program ™ and was measured in hours.|Day 1 (0h to 60h post dose) in each period|PK Evaluable Population: All participants who received at least 1 dose of any study drug and had at least 1 valid PK parameter for at least 1 analyte. 1 participant (ACB treatment sequence) withdrew consent after having received all 3 treatments and did not provide 36-, 48-, or 60-hour samples in Period 3 (Treatment B). This did not impact T-HALF.||hours||Standard Deviation|Mean
673408|NCT01662999|Primary|Area Under the Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration AUC(0-T) of Dapagliflozin From a Single Dose of 10 mg Dapagliflozin Versus AUC(0-T) for Dapagliflozin When Co-administered With 5 mg Saxagliptin|AUC(0-T) is area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (linear up/log down trapezoidal method). Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Plasma samples were analyzed for dapagliflozin by HPLC-MS/MS using a validated method; nominal range of 0.200 to 100 nanograms per milliliter (ng/mL). Actual sampling times were used for PK calculations. AUC(0-T) was derived from the plasma concentration versus time profile for study drug using a validated PK analysis program ™ and was measured in nanograms*hours per milliliter (ng*h/mL).|Day 1 (0h to 60h post dose) in each period|PK Evaluable Population: All participants who received at least 1 dose of any study drug and had at least 1 valid PK parameter for at least 1 analyte. One participant in the ACB treatment sequence withdrew consent after having received all 3 treatments; this participant did not provide 36-, 48-, or 60-hour samples in Period 3 (Treatment B).||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
673409|NCT01662999|Secondary|Time of Maximum Observed Plasma Concentration (Tmax) of Dapagliflozin From a Single Dose of 10 mg Dapagliflozin Versus Tmax of Dapagliflozin When Co-administered With 5 mg Saxagliptin - PK Evaluable Population|Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Plasma samples were analyzed for dapagliflozin by HPLC-MS/MS using a validated method. Actual sampling times were used for PK calculations. Tmax was derived from the plasma concentration versus time profile using a validated PK analysis program ™ and was measured in hours.|Day 1 (0h to 60h post dose) in each period|PK Evaluable Population: All participants who received at least 1 dose of any study drug and had at least 1 valid PK parameter for at least 1 analyte. 1 participant (ACB treatment sequence) withdrew consent after having received all 3 treatments and did not provide 36-, 48-, or 60-hour samples in Period 3 (Treatment B). This did not impact T-HALF.||hours||Full Range|Median
673410|NCT01662999|Primary|Area Under the Concentration-time Curve (AUC) From Time Zero to Infinity [AUC(INF)] of Dapagliflozin From a Single Dose of Dapagliflozin Versus AUC (INF) of Dapagliflozin When Co-administered With Saxagliptin - PK Evaluable Population|AUC(INF) is area under the plasma concentration-time curve from time 0 extrapolated to infinity. Serial blood samples for determination of study drug were collected predose (0 hours (h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Plasma samples were analyzed for dapagliflozin by HPLC-MS/MS using a validated method; nominal range of 0.200 to 100 nanograms per milliliter (ng/mL). Actual sampling times were used for PK calculations. AUC(INF) was derived from the plasma concentration versus time profile for study drug using a validated PK analysis program ™ and was measured in nanograms*hours per milliliter (ng*h/mL).|Day 1 (0h to 60h post dose) in each period|PK Evaluable Population: All participants who received at least 1 dose of any study drug and had at least 1 valid PK parameter for at least 1 analyte. One participant in the ACB treatment sequence withdrew consent after having received all 3 treatments; this participant did not provide 36-, 48-, or 60-hour samples in Period 3 (Treatment B).||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
673411|NCT01662999|Primary|Maximum Observed Plasma Concentration (Cmax) of Dapagliflozin From a Single Dose of Dapagliflozin Versus Cmax of Dapagliflozin From Co-administered Saxagliptin Plus Dapagliflozin - Pharmacokinetic Evaluable Population|The geometric mean of the maximum observed plasma concentration (Cmax) is presented below; serial blood samples for determination of study drug were collected predose (0 hours (h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h,and 60 h postdose, relative to dosing on Day 1 in each cross over period and these data are summarized in the Pharmacokinetic (PK) parameter of Cmax presented here. Plasma samples were analyzed for dapagliflozin by High Performance Liquid chromatography–Mass Spectrometry (HPLC-MS/MS) using a validated method; nominal range of 0.200 to 100 nanograms per milliliter (ng/mL). Dapagliflozin Cmax was derived from plasma concentration versus time data using a non-compartmental method, using a validated PK analysis program ™. Actual sampling times were used for PK calculations. Cmax was reported in ng/mL.|Day 1 (0 h to 60 h post dose) in each period|Pharmacokinetic (PK) Evaluable: All participants who received at least 1 dose of any study drug and had at least 1 valid PK parameter for at least 1 analyte. One participant in the ACB treatment sequence withdrew consent after having received all 3 treatments; this participant did not provide 36-, 48-, or 60-hour samples in Period 3 (Treatment B).||ng/mL||Geometric Coefficient of Variation|Geometric Mean
674114|NCT01654276|Primary|Serum HDL-cholesterol||6 months|||mg/dl||Standard Deviation|Mean
673412|NCT01662986|Secondary|Time to Event: Time to Recovery (EXACT-PRO) From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987)|"Time to event: Time to recovery (EXACT-PRO) was not analysed, only Kaplan Meier curve was plotted.
Time to recovery was assessed with the EXACT-PRO questionnaire. EXACT-PRO total scores were transformed to smooth scores for determining time to recovery and all other endpoints related to the EXACT questionnaire. The day-2 score was transformed to the mean of the total scores recorded on Day 1, 2, and 3. Similarly, each subsequent day’s score was transformed to the mean score using a rolling 3-day average."|from first drug administration to the last timepoint with information of clinical adverse outcome available, Up to 2 years||||||
673413|NCT01662986|Secondary|Exposure of All-cause Hospitalization Event From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987)|Total patient year exposure of all-cause hospitalization was calculated by aggregating the time to min(treatment stop +30, last contact) for on-treatment analysis, or time to last contact for on-study analysis.|from first drug administration to the last timepoint with information of clinical adverse outcome available, Up to 2 years|Treated Set of the pooled twin studies 205.478 and 205.477. The number of patients analyzed for this endpoint from the treated set were 47 for Placebo and 38 for Tiotropium.||patient years|||Number
673414|NCT01662986|Secondary|Number of All-cause Hospitalization Event From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987)|Number of all-cause hospitalization per patient year outcome event occured during the study was analysed descriptively by calculating average occurrence (number of events per patient year drug exposure) by treatment group for on study period using the TS.|from first drug administration to the last timepoint with information of clinical adverse outcome available, Up to 2 years|Treated Set of the pooled twin studies 205.478 and 205.477. The number of patients analyzed for this endpoint from the treated set were 47 for Placebo and 38 for Tiotropium.||hospitalizations per patient year|||Number
673415|NCT01662986|Primary|Percentage of Patients With Next Adverse Clinical Outcome Event From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987).|"Percentage (number) of patients with next adverse clinical outcome event occured during the study, defined as the combined endpoint of Chronic obstructive pulmonary disease (COPD) exacerbations per Boehringer Ingelheim (BI) definition, all-cause re-hospitalization, or all-cause mortality.
Time to the next adverse clinical outcome event from the Two Twin Trials, present 205.478 (NCT01662986) and 205.477 (NCT01663987) was not analysed, only Kaplan Meier curve was plotted. So this endpoint has not been disclosed.
This endpoint was analysed using combined data, as specified in the analysis plan"|from first drug administration to the last timepoint with information of clinical adverse outcome available, Up to 2 years|Treated Set of the pooled twin studies 205.478 and 205.477 : This set includes all patients who were randomized and took at least one dose of the study drug, 157 patients (79 tiotropium and 78 placebo) were included in this set.||Percentage of participants|||Number
673416|NCT01662986|Secondary|Exposure of COPD Exacerbation Events From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987)|Total patient year exposure of COPD was calculated by aggregating the time to min(treatment stop +30, last contact) for on-treatment analysis, or time to last contact for on-study analysis.|start of treatment to the last timepoint with information of clinical adverse outcome available,Up to 2 years|Treated Set of the pooled twin studies 205.478 and 205.477. The number of patients analyzed for this endpoint from the treated set were 73 for Placebo and 54 for Tiotropium.||Patient years|||Number
673417|NCT01662986|Secondary|Number of COPD Exacerbation Events From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987)|Number of COPD exacerbation per patient year outcome event occured during the study was analysed descriptively by calculating average occurrence (number of events per patient year drug exposure) by treatment group for on study period using the TS.|start of treatment to the last timepoint with information of clinical adverse outcome available,Up to 2 years|Treated Set of the pooled twin studies 205.478 and 205.477. The number of patients analyzed for this endpoint from the treated set were 73 for Placebo and 54 for Tiotropium.||exacerbations per patient year|||Number
673418|NCT01662986|Secondary|Percentage of Patients With 30-day Hospital Readmission Rates Outcome Event From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987)|"Percentage (number) of patients with 30-day hospital readmission rates outcome events was analysed.
Days to hospital readmission were calculated as:Hospital readmission days = Readmission date - Date of hospital discharge + 1.
The 30-day hospital readmission analysis summarized the frequency of patients with hospital readmission and readmission days >1 and <31 days using the TS."|from date of hospital discharge prior to randomization upto readmission days >1 and <31 days|Treated Set of the pooled twin studies 205.478 and 205.477||percentage of participants|||Number
673419|NCT01662986|Secondary|Percentage of Patients With All-cause Hospitalization From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987).|"Percentage (number) of patients with all-cause hospitalization outcome event occured during the study was analysed for the combined study.
All-cause hospitalization included all hospitalizations, except planned hospitalizations for elective procedures.
Hospitalizations occurring on the same day as discharge were not considered a separate admission."|from first drug administration to the last timepoint with information of clinical adverse outcome available, Up to 2 years|Treated Set of the pooled twin studies 205.478 and 205.477||percentage of participants|||Number
673420|NCT01662986|Secondary|Percentage of Patients With COPD Exacerbation From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987)|"Percentage (number) of patients with COPD exacerbation on study was analysed for the combined study.
A COPD exacerbation was defined as a complex of lower respiratory events/symptoms (increase or new onset) related to the underlying COPD with duration of three days or more, requiring a change in treatment where a complex of lower respiratory events/symptoms was defined as at least two of the following:
1) Shortness of breath; 2) Sputum production (volume) ; 3) Occurrence of purulent sputum; 4) Cough; 5) Wheezing; 6) Chest tightness.
Onset of exacerbation was defined by the onset of first recorded symptom.The end of exacerbation was decided by the investigator based on clinical judgment.
A required change in treatment included either prescription of antibiotics and/or systemic steroids; and/or a newly prescribed maintenance respiratory medication (i.e., bronchodilators including theophyllines and PDE4-inhibitors)."|from first drug administration to the last timepoint with information of clinical adverse outcome available, Up to 2 years|Treated Set of the pooled twin studies 205.478 and 205.477||percentage of participants|||Number
674115|NCT01654276|Primary|Seum Total Cholesterol||6 months|||mg/dl||Standard Deviation|Mean
673422|NCT01662986|Secondary|Change From Baseline of Trough FEV1 at 12 Weeks on Study Drug From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987)|"Change from baseline of trough FEV1 (forced expiratory volume in 1 second) at 12 weeks on study drug.
Trough FEV1 is defined as the FEV1 measurement prior to the next dosing of study drug and approximately 24 hours after last inhalation of drug."|Baseline and week 12|Treated Set of the pooled twin studies 205.478 and 205.477. The number of patients analyzed at week 12 from the treated set were 59 for Placebo and 60 for Tiotropium.||Litres||Standard Deviation|Mean
673423|NCT01662986|Secondary|Percentage of Patients With Adverse Clinical Event During on Study.|Percentage (number) of patients with adverse clinical event on study, which is defined as the combined endpoint of Chronic obstructive pulmonary disease (COPD) exacerbations per Boehringer Ingelheim (BI) definition, all-cause re-hospitalization, or all-cause mortality.|from first drug administration to the last timepoint with information of clinical adverse outcome available, Up to 2 years|Treated Set (TS)||percentage of participants|||Number
673424|NCT01662986|Secondary|Change From Baseline of Trough FVC at 12 Weeks on Study Drug.|Change from baseline of trough Forced Vital Capacity (FVC) at 12 weeks on study drug.|baseline and 12 weeks|Treated Set (TS). The number of patients analyzed at week 12 from the treated set were 29 for Placebo and 30 for Tiotropium.||Litres||Standard Deviation|Mean
673425|NCT01662986|Primary|Change From Baseline of Trough FEV1 at 12 Weeks on Study Drug.|"Change from baseline of trough FEV1 (forced expiratory volume in 1 second) at 12 weeks on study drug.
Trough FEV1 is defined as the FEV1 measurement prior to the next dosing of study drug and approximately 24 hours after last inhalation of drug."|Baseline and 12 weeks|Treated Set (TS): The treated set included all patients randomized and who took at least one dose of the study drug. The number of patients analyzed at week 12 from the treated set were 29 for Placebo and 30 for Tiotropium.||Litres||Standard Deviation|Mean
673426|NCT01662908|Secondary|Number of Participants With Change From Baseline in the Presence or Absence of Thrombus by Vessel||Baseline to final visit (Day 14-21)|mITT||Participants|||Count of Participants
673427|NCT01662908|Secondary|Number of Participants With Major Adverse Cardiovascular Events (MACE)|MACE is defined as a composite of non-fatal myocardial infarction (MI), non-fatal stroke, non-fatal systemic embolic event (SEE) and cardiovascular death|Initial dose of study drug up to 3 days after last dose|Adjudicated confirmed events in the mITT population||Participants|||Count of Participants
673428|NCT01662908|Secondary|Number of Participants With Recurrence of Venous Thromboembolism (VTE)|Number of participants with investigator-confirmed recurrent VTE events that start or worsen after the first dose of study drug and prior to the date of the final visit or telephone contact (inclusive)|Baseline to final visit (Day 14-21)|mITT||Participants|||Count of Participants
673429|NCT01662908|Secondary|Number of Participants With Clinically Relevant Bleeding|Clinically relevant bleeding was defined as major or clinically relevant non-major bleeding|Initial dose of study drug up to 3 days after last dose|Adjudicated in the mITT population||Participants|||Count of Participants
673430|NCT01662908|Primary|Relative Change From Baseline in Thrombus Volume Assessed by MRI [Using the Magnetic Resonance Venography (MRV) Method]|Thrombus Volume (mm^3) was measured at baseline and between days 14 to 21 using MRI results as determined by Magnetic Resonance Venography (MRV) method, and the relative percentage change from baseline was calculated|Baseline to final visit (Day 14-21)|Modified intention to treat (mITT), defined as intention to treat minus the one patient who did not take the investigational product||percentage of change||Standard Deviation|Mean
673431|NCT01662882|Primary|Mean Cortical to Cerebellum SUVR|Standardized Uptake Value ratio (SUVR) is the ratio of tracer uptake in predefined cortical regions, relative to uptake in the whole cerebellum.|50-60 min after injection|||SUVR||Standard Deviation|Mean
673432|NCT01662882|Primary|Qualitative Amyloid Image Assessment|Five readers blinded to all clinical information classified florbetapir-Positron Emission Tomography (PET) images as either positive for amyloid or negative for amyloid. The majority read was the primary efficacy endpoint for the qualitative evaluation.|50-60 min after injection|||participants|||Number
673433|NCT01662856|Secondary|Prevalence of Treatment Failures|Protocol-defined bleeding at the target bleeding site after the start of treatment or the use of alternative hemostatic treatments (with exception of reversal of heparin) or maneuvers at the target bleeding site after the start of treatment.|From start of treatment until 10 minutes after treatment start|Efficacy analysis was performed on subjects in the Primary Part (II) of the study||percent of subjects|||Number
673434|NCT01662856|Secondary|Cumulative Proportion of Subjects Having Achieved Hemostasis at the Target Bleeding Site by Specified Time Points|"Cumulative proportion of subjects having achieved hemostasis by each of the following time points:
At 5 minutes following start of study treatment
At 7 minutes following start of study treatment
At 10 minutes following start of study treatment"|From start of treatment until 10 minutes after treatment start|Efficacy analysis was performed on subjects in the Primary Part (II) of the study||Percent of subjects achieving hemostasis|||Number
673435|NCT01662856|Secondary|Time to Hemostasis (TTH)|"Time in minutes for achievement of hemostasis at the target bleeding site measured from the start of treatment until 10 minutes after treatment start.
In the Fibrin Sealant Grifols treatment group, the median TTH was calculated based on the estimated survival function S(t), and it is the smallest time at which S(t) is at or below 50%. The 95% CI for the median TTH, on the other hand, was calculated based on the CI for the survival function S(t). The 95% CI for the median TTH was the set of all time points for which the 95% CI of the survival function contains 0.5 (since median is the 50% percentile). Sometimes, the confidence limits for the median cannot be estimated. In our case, the hemostasis was assessed on a discrete scale, and it happened that for all the time points assessed none of the 95% CI of the survival function S(t) contained 0.5. As a result, neither the lower nor the upper limit could be estimated.
All calculations were performed using SAS PROC LIFETEST"|From start of treatment until 10 minutes after treatment start|Efficacy analysis was performed on subjects in the Primary Part (II) of the study||minutes||95% Confidence Interval|Median
673436|NCT01662856|Primary|Proportion of Subjects Achieving Hemostasis by Four Minutes After Treatment Start|Subjects achieving hemostasis at the target bleeding site by 4 minutes following the start of treatment without the occurrence of re-bleeding until the completion of surgical closure.|From start of treatment until 4 minutes after treatment start|Efficacy analysis was performed on subjects in the Primary Part (II) of the study||Percent of subjects achieving hemostasis|||Number
674116|NCT01654276|Primary|Insulin Sensitivity Measured by HOMA (HOmeostasis Model Assessment)||6 months|||Homeostatic model assessment for Insulin||Standard Deviation|Mean
673437|NCT01662791|Secondary|Paffenbarger Physical Activity Questionnaire (PPAQ)|"The PPAQ is a validated, self-administered questionnaire that asks for a recall of physical activity of physical activity over the previous 1-week. From the answers to the questions, a physical activity index (PAI) can be computed, providing an estimate of energy expenditure in kcal/week.
The PAI can be estimated using a list of the physical activities a person performs within a time period and the amount of time spent on each activity, e.g. walking to work, light housework, swimming, carrying bricks at work, or whatever applies to an individual person. There is a value called the physical activity ratio for each activity. The list of activities is used to find the relevant values of physical activity ratios, then an overall physical activity level value for the time period is calculated, using time-weighted averages of the physical activity ratios.
This assessment was only measured at baseline."|Baseline|||kcal/week||Standard Deviation|Mean
673438|NCT01662791|Secondary|Weight Change in Case Group After Treatment|Weight change after treatment|baseline, 3 months|||participants|||Number
673439|NCT01662791|Other Pre-specified|Calories Consumed From Brief Block Food Frequency Questionnaire (FFQ)|"The FFQ is a validated, self-administered semi-quantitative questionnaire used to assess differences in macronutrient, and energy intake. It was designed to provide estimates of usual and customary dietary intake. This questionnaire contains a food list of about 70 food items.
A Food Frequency Questionnaire (FFQ) is a limited checklist of foods and beverages with a frequency response section for subjects to report how often each item was consumed over a specified period of time. Semi-quantitative FFQs collect portion size information as standardized portions or as a choice of portion sizes. Calculations for nutrient intake or calories can be estimated via computerized software programs that multiply the reported frequency of each food by the amount of nutrient or calories in a serving of that food."|Baseline|||Calories||Standard Deviation|Mean
673440|NCT01662791|Secondary|Hospital Anxiety and Depression Scale (HADS)|The HADS is a self-administered 14-item questionnaire (seven for anxiety and seven for depression) Items are rated on a 4-point scale from 0-3 and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression. The cut-offs used for identifying significant psychiatric distress was >/= 8. This assessment was only measured at baseline|Baseline|||units on a scale||Standard Deviation|Mean
673441|NCT01662791|Secondary|Gastrointestinal Symptom Severity Index (GISSI) Over Time in Case Group|The GISSI is a validated, self-administered, multi-dimensional instrument designed to measure the frequency, severity and bothersomeness of individual GI symptoms and to provide subscale scores for interrelated symptom clusters. Factor analyses yielded 5 distinct symptom clusters that were labeled as Constipation/Difficult defecation; Abdominal Pain/Discomfort; Dyspepsia; Diarrhea/Fecal incontinence; Gastroesophageal reflux disease (GERD)/Chest symptoms; and Nausea/Vomiting. Scores could range from 0 to 100, with a higher score indicating greater severity of symptoms.|baseline, 3 months|||units on a scale||Standard Deviation|Mean
673442|NCT01662791|Secondary|Gastrointestinal Symptom Severity Index (GISSI)|The GISSI is a validated, self-administered, multi-dimensional instrument designed to measure the frequency, severity and bothersomeness of individual GI symptoms and to provide subscale scores for interrelated symptom clusters. Factor analyses yielded 5 distinct symptom clusters that were labeled as Constipation/Difficult defecation; Abdominal Pain/Discomfort; Dyspepsia; Diarrhea/Fecal incontinence; Gastroesophageal reflux disease (GERD)/Chest symptoms; and Nausea/Vomiting. Scores could range from 0 to 100, with a higher score indicating greater severity of symptoms.|Baseline|||units on a scale||Standard Deviation|Mean
673443|NCT01662791|Secondary|PD-specific Quality of Life Questionnaire (PDQ-39) Over Time in Case Group|The PDQ-39 is designed to address aspects of functioning and well-being for those affected by Parkinson's disease. This questionnaire is based on a multi-dimensional model of health. Eight subscale scores may be derived from the items: mobility (10 items), activities of daily living (6 items), emotional well-being (6 items), stigma (4 items), social support (3 items), cognitions (4 items), communication (3 items), bodily discomfort (3 items). Patients are asked to think about their health and general well-being and to consider how often in the last month they have experienced certain events (e.g. difficulty walking 100 yards). Patients are asked to indicate the frequency of each event by selecting one of 5 options (Likert Scale): Never/occasionally/sometimes/often/always or cannot do at all. Each dimension is calculated as a scale from 0 to 100, with 0= no problem at all; 100= maximum level of problem. Sub-scale score are averaged to calculate the summary index.|Baseline and 3 months|||units on a scale||Standard Deviation|Mean
673444|NCT01662791|Secondary|PD-specific Quality of Life Questionnaire (PDQ-39)|The PDQ-39 is designed to address aspects of functioning and well-being for those affected by Parkinson's disease. This questionnaire is based on a multi-dimensional model of health. Eight subscale scores may be derived from the items: mobility (10 items), activities of daily living (6 items), emotional well-being (6 items), stigma (4 items), social support (3 items), cognitions (4 items), communication (3 items), bodily discomfort (3 items). Patients are asked to think about their health and general well-being and to consider how often in the last month they have experienced certain events (e.g. difficulty walking 100 yards). Patients are asked to indicate the frequency of each event by selecting one of 5 options (Likert Scale): Never/occasionally/sometimes/often/always or cannot do at all. Each dimension is calculated as a scale from 0 to 100, with 0= no problem at all; 100= maximum level of problem. Sub-scale score are averaged to calculate the summary index.|baseline|||units on a scale||Standard Deviation|Mean
673445|NCT01662791|Primary|Number of Subjects With Small Bowel Bacterial Overgrowth (SBBO)|SBBO is measured by the Hydrogen Breath Test, which measures the hydrogen and methane gas produced by bacteria in the small bowel that has diffused into the blood, then lungs for expiration. After an overnight fast, subjects ingested a solution consisting of 50 grams of glucose mixed in 150 mL of water. Immediately before ingestion of glucose and at 20-minute intervals for 2 hours following ingestion, laboratory staff collected end-expiratory breath samples and analyzed them for hydrogen and methane using a Quintron sample correction (SC) breath microlyzer. A diagnosis of SBBO was defined by an increase in expiration of 12 parts per million (ppm) or more of hydrogen and/or methane.|Baseline to 2 hours|||participants|||Number
673446|NCT01662765|Other Pre-specified|Costs|from initial treatment to the complete healing, all kind of cost will be calculated.|two year|||USD dollars||Standard Deviation|Mean
673447|NCT01662765|Secondary|Visual Analogue Scale for Patient Satisfaction (VAS-PS)|Well-being and satisfaction scales comprised linear metric scales known as “visual analogue scales,” with grades from 0 (worst imaginable health state and extremely dissatisfied with the treatment) to 100 (best imaginable health state and extremely satisfied with the treatment).|30 days|||units on a scale||Standard Deviation|Mean
673449|NCT01662765|Primary|Cure Rate|"Primary outcome was the cure rate. Absence of recurrence within two year after the first treatment was considered as a cure.
Recurrence was defined as the appearance of a new, active discharging sinus or granulation tissue with/without a bit of hairs in the deep of the umbilicus within two years after therapy."|2 year after initial treatment|Of the 84 patients 41 patients in the CT group. and 40 patients in ST group were analyzed||participants|||Number
673450|NCT01662648|Secondary|Number of Participants Within Each Category of Patient Satisfaction Score|Participants were interviewed at baseline and at the end of the trial (Week 26) to assess their satisfaction with the current treatment on a 5-point scale (very good, good, reasonable, moderate or poor). Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.|Baseline and Week 26|"ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.N (number of participants analyzed) signifies participants evaluable for this measure and n signifies those participants who were evaluated for this measure at specified time point."||participants|||Number
673451|NCT01662648|Secondary|Change From Baseline in Daytime Drowsiness at Week 26|"Daytime Drowsiness was assessed by an 11-point visual analog scale that rates how well participants sleep. Participants indicated on the scale (from 0 to 100 millimeter) how often they have felt drowsy within the previous 7 days (from 0: not at all to 100:all the time). Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone."|Baseline and Week 26|"ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. N (number of participants analyzed) signifies the participants evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points."||millimeter (mm)||Standard Deviation|Mean
673452|NCT01662648|Secondary|Change From Baseline in Sleep Quality at Week 26|"Sleep quality was assessed by an 11-point visual analog scale that rates how well participants sleep. Participants indicated on the scale (from 0 to 100 millimeter) how well they have slept in the previous 7 days (from 0: very badly to 100: very well). Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone."|Baseline and Week 26|"ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. N (number of participants analyzed) signifies the participants evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points."||millimeter (mm)||Standard Deviation|Mean
673453|NCT01662648|Secondary|Change From Baseline in Personal and Social Performance (PSP) Scale at Week 26|The PSP scale assesses the degree of dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less or equal to 30, functioning so poorly as to require intensive supervision. Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.|Baseline and Week 26|"ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. N (number of participants analyzed) signifies the participants evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points."||units on a scale||Standard Deviation|Mean
673454|NCT01662648|Secondary|Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 26|"The CGI rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 indicates to normal, not at all ill and a rating of 7 indicates among the most extremely ill participants. Higher scores indicate worsening. Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone."|Baseline and Week 26|"ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. N (number of participants analyzed) signifies the participants evaluable for this measure."||units on a scale||Standard Deviation|Mean
673455|NCT01662648|Secondary|Change From Baseline in PANSS Total Negative Subscale Score at Week 26|The Negative Subscale of PANSS (Positive and Negative Syndrome Scale) assesses seven negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, ranging from 7 (absent) to 49 (extreme psychopathology). Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.|Baseline and Week 26|"ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. N (number of participants analyzed) signifies the participants evaluable for this measure."||units on a scale||Standard Deviation|Mean
673456|NCT01662648|Secondary|Change From Baseline in PANSS Total Positive Subscale Score at Week 26|The Positive Subscale of PANSS (Positive and Negative Syndrome Scale) assesses seven positive-symptoms of schizophrenia. Positive symptoms refer to an excess of or distortion of normal functions. The symptoms are rated on a 7-point scale, ranging from 7 (absent) to 49 (extreme psychopathology). Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.|Baseline and Week 26|"ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. N (number of participants analyzed) signifies the participants evaluable for this measure."||units on a scale||Standard Deviation|Mean
673516|NCT01662102|Secondary|Overall Response Rate (ORR)|Tumor response will be evaluated according to Cheson criteria at the time of randomization and at the end of the 2-year maintenance/observation, post randomization. ORR is defined as the proportion of patients with a CR or a PR, and will be compared between treatment groups. Patients with no response evaluation (for any reason) will be considered as not evaluable (NE).|Up to 7 years||||||
673457|NCT01662648|Secondary|Percentage of Participants With Greater Than or Equal to 20 Percent (%) Improvement in PANSS Total Score at Week 26|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening. Percentage of participants with greater than or equal to 20 % improvement in PANSS total score is reported here. Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.|Week 26|"ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. N (number of participants analyzed) signifies the participants evaluable for this measure."||percentage of participants|||Number
673458|NCT01662648|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 26|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening. Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.|Baseline and Week 26|"Intent to Treat (ITT) population for efficacy included all the participants who received paliperidone extended-release (ER) at least once and who had at least 1 post baseline efficacy assessment. N (number of participants analyzed) signifies the participants evaluable for this measure."||units on a scale||Standard Deviation|Mean
673459|NCT01662635|Primary|FISH, IHC, RT-qPCR Comparison|200 samples underwent FISH, from them 63 underwent IHC and 48 RT-qPCR.|TWO YEARS|The only selection criteria of our subjets was the availability of tumor tissue to perform tests.||participants|||Number
673460|NCT01662583|Secondary|Number of Subjects Who Receive the 2nd Dose of the Influenza Vaccine on Time.||by 42 days after dose of first vaccination|One patient in the plain text message arm was removed for this analysis because they received the second dose too early and was not re-vaccinated||percentage of participants|||Number
673461|NCT01662583|Primary|Receipt of 2nd Dose of the Influenza Vaccine.||by April 30th after receipt of first dose (up to 8 months)|||percentage of participants|||Number
673462|NCT01662531|Secondary|Consumption of rIX-FP During Routine Prophylaxis|Consumption of rIX-FP during routine prophylaxis is expressed as the total prophylaxis dose per month.|12 months|Efficacy Population||IU/kg/month||Standard Deviation|Mean
673463|NCT01662531|Secondary|Number of Bleeding Episodes Requiring One, Two or More Than Two Infusions of rIX-FP to Achieve Hemostasis|For each bleeding episode that required treatment, the number of episodes that required one, two or more than two infusions of rIX-FP to achieve hemostasis|Approximately 12 months|Efficacy Population||bleeding episodes|||Number
673464|NCT01662531|Secondary|Number of Subjects Developing Antibodies Against rIX-FP|Antibodies to rIX-FP were measured using a direct-binding enzyme-linked immunosorbent assay (ELISA).|12 months|Safety Population||participants|||Number
673465|NCT01662531|Secondary|Number of Subjects With Treatment-related Adverse Events||12 months|Safety Population||participants|||Number
673466|NCT01662531|Primary|Number of Subjects Developing Inhibitors to Factor IX (FIX)|Inhibitor formation was defined as any inhibitor (≥0.6 BU [Bethesda Units]/mL) identified and confirmed by retesting.|12 months|Safety Population||participants|||Number
673467|NCT01662531|Primary|Clearance for FIX Activity Following a Single Intravenous Dose of 50 IU/kg rIX-FP or Previous FIX Product|FIX activity was measured at a central laboratory using validated one-stage clotting method. FIX levels were not corrected for baseline values. Clearance is normalized for body weight.|Pre-dose, 30 minutes, 3, 24, 48, 72 120, 168, 240 and 336 hours post-dose|PK Population||mL/hr/kg||Standard Deviation|Mean
673468|NCT01662531|Primary|Area Under the Concentration Versus Time Curve From Time Point Zero to the Last Sample With Quantifiable Drug Concentration (AUClast)|"AUClast following a single intravenous dose of 50 IU/kg rIX-FP or previous FIX product.
FIX activity was measured at a central laboratory using validated one-stage clotting method. FIX levels were not corrected for baseline values."|Pre-dose, 30 minutes, 3, 24, 48, 72 120, 168, 240 and 336 hours post-dose|PK Population||IU*hr/dL||Standard Deviation|Mean
673469|NCT01662531|Primary|Half-life (t1/2) Following a Single Intravenous Dose of 50 IU/kg rIX-FP or Previous FIX Product|FIX activity was measured at a central laboratory using validated one-stage clotting method. FIX levels were not corrected for baseline values.|Pre-dose, 30 minutes, 3, 24, 48, 72 120, 168, 240 and 336 hours post-dose|PK Population||hours||Standard Deviation|Mean
673470|NCT01662531|Primary|Incremental Recovery Following a Single Intravenous Dose of 50 IU/kg rIX-FP or Previous FIX Product|Incremental recovery (IU/dL/IU/kg) is defined as the FIX activity (IU/dL) obtained 30 minutes following infusion, per dose of (IU/kg) infusion. FIX activity was measured at a central laboratory using validated one-stage clotting method. Recovery values were baseline-corrected for pre-infusion plasma FIX activity. Incremental recovery was measured following a single intravenous dose of 50 IU/kg rIX-FP on Day 1. Analysis of previous FIX product was conducted at the beginning of the study in a subset of subjects who had no historical pharmacokinetic (PK) data of their previous FIX product. For the PK assessment, the previous FIX product was administered by IV infusion after approximately 4 days following the last FIX treatment, prior to any dosing of rIX-FP. The formal PK population consisted of subjects who received at least 1 dose of rIX-FP for PK assessment and for whom a sufficient number of analyzable PK samples had been obtained to permit the evaluation of the PK profile of rIX-FP.|30 minutes after infusion|PK Population||(IU/dL)/(IU/kg)||Standard Deviation|Mean
673471|NCT01662492|Secondary|Percentage of Patients Who Are Prescribed Oral Rescue Migraine Prophylactic Treatment|Percentage of patients who are prescribed oral rescue migraine prophylactic treatment during the 28-day period ending with Week 12 in the Intent-to-Treat population.|12 Weeks|Intent-to-Treat (ITT) Population: All randomized subjects.||Percentage of participants|||Number
673517|NCT01662102|Secondary|Overall Survival (OS)|OS is defined as the time from randomization to death from any cause. In living patients, survival time will be censored on the last date patients were known to be alive.|Up to 7 years||||||
674117|NCT01654276|Primary|Serum Insulin||6 months|||mU/L||Standard Deviation|Mean
674118|NCT01654276|Primary|Serum Glucose||6 months|||mg/dl||Standard Deviation|Mean
673472|NCT01662492|Secondary|Percentage of Patients With ≥ 50% Decrease From Baseline in the Frequency of Headache Days|Percentage of patients with ≥ 50% decrease from baseline in the frequency of headache days during the 28-day period ending with Week 12 in the Intent-to-Treat Population. A responder for headache days was defined as a patient with a 50% decrease in change from baseline in the frequency of headache days.|Baseline, 12 Weeks|Intent-to-Treat (ITT) Population: All randomized subjects.||Percentage of participants|||Number
673473|NCT01662492|Secondary|Change From Baseline in the Total Cumulative Hours of Headache on Headache Days|Change From Baseline in the Total Cumulative Hours of Headache on Headache Days during the 28-day period ending with Week 12 in the Intent-to-Treat Population. Total cumulative hours is defined as the sum of total duration of headaches on headache days.|Baseline, 12 Weeks|Intent-to-Treat (ITT) Population: All randomized subjects.||Cumulative hours of headache||Standard Deviation|Mean
673474|NCT01662492|Secondary|Change From Baseline in the Frequency of Severe Headache Days|Change from baseline in the frequency of severe headache days during the 28-day period, ending with Week 12 in the Intent-to-Treat population. A severe headache day is defined as a calendar day with 1 or more total hours of headache and with maximum severity reported as 'severe' for the day as recorded by the patient in the electronic diary.|Baseline, 12 Weeks|Intent-to-Treat (ITT) Population: All randomized subjects.||Severe Headache Days||Standard Deviation|Mean
673475|NCT01662492|Primary|Change From Baseline in the Frequency of Headache Days|Change from baseline in the frequency of headache days during the 28-day period, ending with Week 12 in the Intent-to-Treat population. A headache day for a patient is defined as a calendar day with 1 or more total hours of headache as recorded by the patient in the electronic diary.|Baseline, 12 Weeks|Intent-to-Treat (ITT) Population: All randomized subjects.||Headache days||Standard Deviation|Mean
674119|NCT01654276|Primary|Ambulatory Diastolic Blood Pressure|Diastolic BP by ambulatory blood pressure monitor.|6 months|||mmHg||Standard Deviation|Mean
673491|NCT01662362|Secondary|ESA Testing of Preselected Donor Specimens Nonreactive by ABBOTT PRISM Chagas||Up to six months|||percentage of specimens ESA negative||95% Confidence Interval|Number
673492|NCT01662362|Primary|ESA Chagas Testing of US Blood Donor Specimens Repeatedly Reactive by ABBOTT PRISM Chagas||Up to six months|||percent agreement to RIPA||95% Confidence Interval|Number
673493|NCT01662310|Secondary|Open-label Extension (OLE) Phase: Change From OLE Baseline in Personal and Social Performance (PSP) Scale Total Score at OLE Endpoint|The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty). Percentage of participants achieving improvement in PSP score by at least one category was reported. Change at OLE endpoint was calculated as value at OLE endpoint (24 weeks after DB phase (26 April 2013) minus value at OLE Baseline (09 November 2012).|OLE Baseline (09 November 2012) up to OLE endpoint (that is, up to 24 Weeks [26 April 2013] from DB endpoint)|"The ITT OLE analysis set included all participants who received at least one dose of OLE medication as recorded on the electronic case report form (eCRF). LOCF method was used to impute missing values. N (number of participants analyzed) signifies the participants evaluable for this measure."||Units on a scale||Standard Deviation|Mean
673494|NCT01662310|Secondary|Open-label Extension (OLE) Phase: Change From OLE Baseline in Clinical Global Impression-Severity Scale (CGI-S) Total Score at OLE Endpoint|CGI-S is a 7-point clinician-rated scale to assess severity of participant's current illness state, ranging from (1)Normal, not ill at all, (2)Borderline mentally ill, (3)Mildly ill, (4)Moderately ill, (5)Markedly ill, (6)Severely ill, (7)Among the most severely ill. Change at OLE endpoint was calculated as value at OLE endpoint (24 weeks after DB phase (26 April 2013) minus value at OLE Baseline (09 November 2012).|OLE Baseline (09 November 2012) up to OLE endpoint (that is, up to 24 Weeks [26 April 2013] from DB endpoint)|"The ITT OLE analysis set included all participants who received at least one dose of OLE medication as recorded on the electronic case report form (eCRF). LOCF method was used to impute missing values. N (number of participants analyzed) signifies the participants evaluable for this measure."||Units on a scale||Standard Deviation|Mean
673518|NCT01662102|Secondary|Time to Next Chemotherapy (TTNCT)|TTNCT is defined as the time from randomization to the first introduction of any new chemotherapy (cytotoxic or radioimmunotherapy). The TTNCT may be the same as the TTNLT. Patients who respond to treatment and patients who are lost to follow-up will be censored at the visit on which the dosing of a new medication was evaluated.|Up to 7 years||||||
673519|NCT01662102|Secondary|Time to Next Anti-Lymphoma Treatment (TTNLT)|TTNLT is defined as the time from randomization to the first introduction of any new anti lymphoma regimen.|Up to 7 years||||||
673495|NCT01662310|Secondary|Open-label Extension (OLE) Phase: Change From OLE Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at OLE Endpoint|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening. Change at OLE endpoint was calculated as value at OLE endpoint (24 weeks after DB phase (26 April 2013) minus value at OLE Baseline (09 November 2012).|OLE Baseline (09 November 2012) up to OLE endpoint (that is, up to 24 Weeks [26 April 2013] from DB endpoint)|"The Intent-to-Treat (ITT) OLE analysis set included all participants who received at least one dose of OLE medication as recorded on the electronic case report form (eCRF). LOCF method was used to impute missing values. N (number of participants analyzed) signifies the participants evaluable for this measure."||Units on a scale||Standard Deviation|Mean
673496|NCT01662310|Secondary|Double Blind (DB) Phase: Median Time to Relapse (Final Analysis)|A relapse is defined as any one of the following: 1. involuntary or voluntary psychiatric hospitalization 2. deliberate self-injury or violent behavior; 3. Suicidal or homicidal ideation and clinically significant aggressive behavior; 4. 25 percent (%) increase in Positive and Negative Syndrome Scale (PANSS) total score for 2 consecutive assessments for participants whose score was greater than 40 at randomization, or a 10-point increase for participants who scored less than or equal to (≤) 40 at randomization; 5. increase for 2 consecutive assessments in PANSS items (delusions, conceptual disorganization, hallucinatory behavior, suspiciousness, hostility or uncooperativeness) to greater than or equal to (≥) 5 for participants who scored ≤3 at randomization, or to ≥6 for participants with initial score of 4. Independent Data Monitoring Committee performed final analysis at the end of double-blind treatment (09 November 2012).|DB Baseline (Day 1 of Week 15) up to study completion (09 November 2012) (Approximately 1 year)|The Intent-to-Treat DB analysis set included all the participants who were randomized into the DB phase and who received at least one dose of DB study medication up to final analysis cut-off date (09-Nov-2012).||Days||95% Confidence Interval|Median
673497|NCT01662310|Secondary|Double Blind (DB) Phase: Change From DB Baseline in Daytime Drowsiness Based on Visual Analog Scale (VAS) at DB Endpoint|"Daytime drowsiness was assessed by an 11-point visual analog scale that rates how well participants slept. Participants indicated on the scale (from 0 to 100 millimeter) how often they felt drowsy in the previous 7 days (from 0: very badly to 100: very well). Change at DB endpoint was calculated as value at interim analysis data cut-off (09 November 2012) minus value at DB Baseline (Day 1 of week 15)."|DB Baseline (Day 1 of Week 15) up to DB endpoint (study completion [09 November 2012] [Approximately 1 year])|"The Intent-to-Treat DB analysis set included all the participants who were randomized into the DB phase and who received at least one dose of DB study medication. n signifies those participants who were evaluated for this measure at the specified time point."||Millimeter (mm)||Standard Deviation|Mean
673498|NCT01662310|Secondary|Run-In and Stabilization Phase: Change From Baseline in Daytime Drowsiness Based on Visual Analog Scale (VAS) at Week 14|"Daytime drowsiness was assessed by an 11-point visual analog scale that rates how well participants slept. Participants indicated on the scale (from 0 to 100 millimeter) how often they felt drowsy in the previous 7 days (from 0: very badly to 100: very well)."|Baseline and Week 14|"The Intent-to-Treat (RI/ST) analysis set included all the participants who received at least one dose of study medication in run-in phase or stabilization phase. n signifies those participants who were evaluated for this measure at the specified time point. LOCF method was used to impute missing values."||Millimeter (mm)||Standard Deviation|Mean
673499|NCT01662310|Secondary|Double Blind (DB) Phase: Change From DB Baseline in Sleep Quality Based on Visual Analog Scale (VAS) at DB Endpoint|"Sleep quality was assessed by an 11-point visual analog scale that rates how well participants slept. Participants indicated on the scale (from 0 to 100 millimeter) how well they slept in the previous 7 days (from 0: very badly to 100: very well). Change at DB endpoint was calculated as value at interim analysis data cut-off (09 November 2012) minus value at DB Baseline (Day 1 of week 15)."|DB Baseline (Day 1 of Week 15) up to DB endpoint (study completion [09 November 2012] [Approximately 1 year])|"The Intent-to-Treat DB analysis set included all the participants who were randomized into the DB phase and who received at least one dose of DB study medication. n signifies those participants who were evaluated for this measure at the specified time point."||Millimeter (mm)||Standard Deviation|Mean
673500|NCT01662310|Secondary|Run-In and Stabilization Phase: Change From Baseline in Sleep Quality Based on Visual Analog Scale (VAS) at Week 14|"Sleep quality was assessed by an 11-point visual analog scale that rates how well participants slept. Participants indicated on the scale (from 0 to 100 millimeter) how well they slept in the previous 7 days (from 0: very badly to 100: very well)."|Baseline and Week 14|"The Intent-to-Treat (RI/ST) analysis set included all the participants who received at least one dose of study medication in run-in phase or stabilization phase. n signifies those participants who were evaluated for this measure at the specified time point. LOCF method was used to impute missing values."||Millimeter (mm)||Standard Deviation|Mean
673501|NCT01662310|Secondary|Double Blind (DB) Phase: Change From DB Baseline in Personal and Social Performance (PSP) Scale Total Score at DB Endpoint|The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty). Percentage of participants achieving improvement in PSP score by at least one category was reported. Change at DB endpoint was calculated as value at interim analysis data cut-off (09 November 2012) minus value at DB Baseline (Day 1 of week 15).|DB Baseline (Day 1 of Week 15) up to DB endpoint (study completion [09 November 2012] [Approximately 1 year])|The Intent-to-Treat DB analysis set included all the participants who were randomized into the DB phase and who received at least one dose of DB study medication.||Units on a scale||Standard Deviation|Mean
673520|NCT01662102|Secondary|Time to Progression (TTP)|TTP is defined as the time from randomization to the first disease progression.|Up to 7 years||||||
673521|NCT01662102|Secondary|Event Free Survival|EFS time is defined as the time from randomization to first documented progression, death from any cause, or introduction of a new anti-lymphoma treatment (chemotherapy, radiotherapy or immunotherapy).|Up to 7 years||||||
673502|NCT01662310|Secondary|Run-In and Stabilization Phase: Change From Baseline in Personal and Social Performance (PSP) Scale Total Score at Week 14|The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty). Percentage of participants achieving improvement in PSP score by at least one category was reported.|Baseline and Week 14|"The Intent-to-Treat (RI/ST) analysis set included all the participants who received at least one dose of study medication in run-in phase or stabilization phase. n signifies those participants who were evaluated for this measure at the specified time point. LOCF method was used to impute missing values."||Units on a scale||Standard Deviation|Mean
673503|NCT01662310|Secondary|Double Blind (DB) Phase: Change From DB Baseline in Clinical Global Impression-Severity Scale (CGI-S) Total Score at DB Endpoint|CGI-S is a 7-point clinician-rated scale to assess severity of participant's current illness state, ranging from (1)Normal, not ill at all, (2)Borderline mentally ill, (3)Mildly ill, (4)Moderately ill, (5)Markedly ill, (6)Severely ill, (7)Among the most severely ill. Change at DB endpoint was calculated as value at interim analysis data cut-off (09 November 2012) minus value at DB Baseline (Day 1 of week 15).|DB Baseline (Day 1 of Week 15) up to DB endpoint (study completion [09 November 2012] [Approximately 1 year])|The Intent-to-Treat DB analysis set included all the participants who were randomized into the DB phase and who received at least one dose of DB study medication.||Units on a scale||Standard Deviation|Mean
673504|NCT01662310|Secondary|Run-In and Stabilization Phase: Number of Participants Assessed With Categorical Scores Based on Clinical Global Impression-Severity Scale (CGI-S)|The CGI-S is a 7-point clinician-rated scale to assess severity of participant's current illness state, ranging from (1)Normal, not ill at all, (2)Borderline mentally ill, (3)Mildly ill, (4)Moderately ill, (5)Markedly ill, (6)Severely ill, (7)Among the most severely ill.|Baseline and Week 14|"The Intent-to-Treat (RI/ST) analysis set included all the participants who received at least one dose of study medication in run-in phase or stabilization phase. n signifies those participants who were evaluated for this measure at the specified time point."||Participants|||Number
673505|NCT01662310|Secondary|Double Blind (DB) Phase: Change From DB Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at DB Endpoint|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening. Change at DB endpoint was calculated as value at interim analysis data cut-off (09 November 2012) minus value at DB Baseline (Day 1 of week 15).|DB Baseline (Day 1 of Week 15) up to DB endpoint (study completion [09 November 2012] [Approximately 1 year])|The Intent-to-Treat DB analysis set included all the participants who were randomized into the DB phase and who received at least one dose of DB study medication. LOCF method was used to impute missing values.||Units on a scale||Standard Deviation|Mean
673506|NCT01662310|Secondary|Run-In and Stabilization Phase: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 14|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Baseline and Week 14|"The Intent-to-Treat (RI/ST) analysis set included all the participants who received at least one dose of study medication in run-in phase or stabilization phase. n signifies those participants who were evaluated for this measure at the specified time point. Last observation carried forward (LOCF) method was used to impute missing values."||Units on a scale||Standard Deviation|Mean
673507|NCT01662310|Primary|Double Blind (DB) Phase: Median Time to Relapse|A relapse is defined as any one of the following: 1. involuntary or voluntary psychiatric hospitalization 2. deliberate self-injury or violent behavior; 3. Suicidal or homicidal ideation and clinically significant aggressive behavior; 4. 25 percent (%) increase in Positive and Negative Syndrome Scale (PANSS) total score for 2 consecutive assessments for participants whose score was greater than 40 at randomization, or a 10-point increase for participants who scored less than or equal to (≤) 40 at randomization; 5. increase for 2 consecutive assessments in PANSS items (delusions, conceptual disorganization, hallucinatory behavior, suspiciousness, hostility or uncooperativeness) to greater than or equal to (≥) 5 for participants who scored ≤3 at randomization, or to ≥6 for participants with initial score of 4. Independent Data Monitoring Committee performed ongoing safety monitoring during double-blind treatment and conducted the interim analysis after 61 relapse events had taken place.|DB Baseline (Day 1 of Week 15) up to interim analysis data cut-off (24 August 2012) (Approximately 1 year)|"The Intent-to-Treat DB analysis set included all the participants who were randomized into the DB phase and who received at least one dose of DB study medication up to interim analysis cut-off date (24-Aug-2012). N (number of participants analyzed) signifies the participants evaluable for this measure."||Days||95% Confidence Interval|Median
673508|NCT01662115|Secondary|Use of NG Tubes|Nasogastric tube (re)insertions|30 days|||NG Tubes use||Full Range|Mean
673509|NCT01662115|Secondary|Post-operative Vomiting|Episodes of vomiting|30 days|||vomiting episodes||Full Range|Mean
673510|NCT01662115|Secondary|Hospital Stay|Length of postoperative hospital stay|30 days|||days||Full Range|Mean
673511|NCT01662115|Primary|Bowel Function Recovery|Time to first bowel movement or flatus|7 days|||days||Full Range|Mean
673512|NCT01662102|Primary|Progression Free Survival|Statistical Analysis of primary outcome measure data was not performed due to only one patient being enrolled in this study.|24 months|Statistical Analysis of primary outcome measure data was not performed due to only one patient being enrolled in this study.|||||
673513|NCT01662102|Secondary|Pharmacoeconomics (Cost Effectiveness Analysis)|A cost-effectiveness analysis will be done that compares the efficiency (cost/effectiveness unit) of consolidation treatment with 90Y-ibritumomab tiuxetan compared to maintenance treatment with rituximab. The analysis will be conducted according to a health economic analysis plan independent from this clinical study protocol.|Up to 24 months||||||
673523|NCT01662063|Secondary|Percentage of Participants With Remission According to DAS28, SDAI, and Boolean Criteria|Remission was defined as DAS28 <2.6, SDAI ≤3.3, or meeting all Boolean criteria (28-count SJC and TJC ≤1, VAS ≤10 mm, and hsCRP ≤1 mg/dL). For DAS28 and SDAI formulas, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The DAS28 was calculated as (0.56 × square root of TJC) + (0.28 × square root of SJC) + (0.7 × ln ESR) + (0.014 × VAS), with potential scores from 0 to 10. The SDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician) + hsCRP, with potential scores from 0 to infinity. However, based upon normal hsCRP level within 1 mg/dL, scores would be expected to fall within ≤77 points. For these instruments, higher scores indicate increased disease activity. The percentage of participants who met criteria for remission was calculated at each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table."||percentage of participants|||Number
673524|NCT01662063|Secondary|Number of Participants With Remission According to DAS28, SDAI, and Boolean Criteria|Remission was defined as DAS28 <2.6, SDAI ≤3.3, or meeting all Boolean criteria (28-count SJC and TJC ≤1, VAS ≤10 mm, and hsCRP ≤1 mg/dL). For DAS28 and SDAI formulas, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The DAS28 was calculated as (0.56 × square root of TJC) + (0.28 × square root of SJC) + (0.7 × ln ESR) + (0.014 × VAS), with potential scores from 0 to 10. The SDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician) + hsCRP, with potential scores from 0 to infinity. However, based upon normal hsCRP level within 1 mg/dL, scores would be expected to fall within ≤77 points. For these instruments, higher scores indicate increased disease activity. The number of participants who met criteria for remission was reported at each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table."||participants|||Number
673525|NCT01662063|Secondary|Percentage of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria|Low disease activity was defined as DAS28 ≤3.2, SDAI ≤11, or CDAI ≤10. For each formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The DAS28 was calculated as (0.56 × square root of TJC) + (0.28 × square root of SJC) + (0.7 × ln ESR) + (0.014 × VAS), with potential scores from 0 to 10. The SDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician) + hsCRP, with potential scores from 0 to infinity. However, based upon normal hsCRP level within 1 mg/dL, scores would be expected to fall within ≤77 points. The CDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician), with potential scores from 0 to 76. For all instruments, higher scores indicate increased disease activity. The percentage of participants who met criteria for low disease activity was calculated at each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84|ITT Population; only those participants who provided evaluable data (n) were included in the analysis.||percentage of participants|||Number
673526|NCT01662063|Secondary|Number of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria|Low disease activity was defined as DAS28 ≤3.2, SDAI ≤11, or CDAI ≤10. For each formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The DAS28 was calculated as (0.56 × square root of TJC) + (0.28 × square root of SJC) + (0.7 × ln ESR) + (0.014 × VAS), with potential scores from 0 to 10. The SDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician) + hsCRP, with potential scores from 0 to infinity. However, based upon normal hsCRP level within 1 mg/dL, scores would be expected to fall within ≤77 points. The CDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician), with potential scores from 0 to 76. For all instruments, higher scores indicate increased disease activity. The number of participants who met criteria for low disease activity was reported at each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84|ITT Population; only those participants who provided evaluable data (n) were included in the analysis.||participants|||Number
673527|NCT01662063|Secondary|Percentage of Participants With HAQ-DI Score <0.5|The Stanford HAQ-DI was calculated as the average of 20 questions, each scored from 0 (no difficulty) to 3 (unable to do). The questionnaire included 8 component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common activities. Overall scores may range from 0 to 3, with higher scores representing increased disability. The percentage of participants achieving a score <0.5 was calculated at each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84|ITT Population; only those participants who provided evaluable data (n) were included in the analysis.||percentage of participants|||Number
673528|NCT01662063|Secondary|Change From Baseline in HAQ-DI Score|The Stanford HAQ-DI was calculated as the average of 20 questions, each scored from 0 (no difficulty) to 3 (unable to do). The questionnaire included 8 component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common activities. Overall scores may range from 0 to 3, with higher scores representing increased disability. The change from Baseline to each visit was calculated, where positive changes represent an increased need for assistance with daily activities.|Baseline to Weeks 12, 24, 36, 48, 60, 72, 84|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table."||units on a scale||Standard Deviation|Mean
673529|NCT01662063|Secondary|Heath Assessment Questionnaire-Disability Index (HAQ-DI) Score|The Stanford HAQ-DI was calculated as the average of 20 questions, each scored from 0 (no difficulty) to 3 (unable to do). The questionnaire included 8 component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common activities. Overall scores may range from 0 to 3, with higher scores representing increased disability.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84|ITT Population; only those participants who provided evaluable data (n) were included in the analysis.||units on a scale||Standard Deviation|Mean
673530|NCT01662063|Secondary|Change From Baseline in Global Assessment of Pain by the Participant According to VAS Score|"The Global Assessment of Pain was performed using a 100-mm horizontal VAS. Scores may range from 0 mm (no pain) to 100 mm (unbearable pain), with higher scores representing an increase in pain. The change from Baseline to each visit was calculated, where positive changes represent an increase or worsening in pain."|Baseline to Weeks 12, 24, 36, 48, 60, 72, 84|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table."||mm||Standard Deviation|Mean
673531|NCT01662063|Secondary|Global Assessment of Pain by the Participant According to VAS Score|"The Global Assessment of Pain was performed using a 100-mm horizontal VAS. Scores may range from 0 mm (no pain) to 100 mm (unbearable pain), with higher scores representing an increase in pain."|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84|ITT Population; only those participants who provided evaluable data (n) were included in the analysis.||mm||Standard Deviation|Mean
673532|NCT01662063|Secondary|Change From Baseline in Global Assessment of Disease Activity by the Participant According to VAS Score|"The Global Assessment of Disease Activity was performed using a 100-mm horizontal VAS. Scores may range from 0 mm (no disease activity) to 100 mm (maximum disease activity), with higher scores representing an increase in perceived symptoms. The change from Baseline to each visit was calculated, where positive changes represent an increase or worsening in perceived disease activity."|Baseline to Weeks 12, 24, 36, 48, 60, 72, 84|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table."||mm||Standard Deviation|Mean
673533|NCT01662063|Secondary|Global Assessment of Disease Activity by the Participant According to Visual Analog Scale (VAS) Score|"The Global Assessment of Disease Activity was performed using a 100-mm horizontal VAS. Scores may range from 0 mm (no disease activity) to 100 mm (maximum disease activity), with higher scores representing an increase in perceived symptoms."|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84|ITT Population; only those participants who provided evaluable data (n) were included in the analysis.||mm||Standard Deviation|Mean
673534|NCT01662063|Secondary|Time to Return to the QW Regimen After Switching to the Q2W Regimen|Participants could switch between regimens at the Investigator's judgment based upon safety, efficacy, and pharmacokinetic/pharmacodynamic data. Time to return was defined as the time between switching to the Q2W regimen and returning to the previous QW regimen.|From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)|ITT Population; only participants who switched from the QW to Q2W regimen and returned to the QW regimen were included.||weeks||Full Range|Median
673535|NCT01662063|Secondary|Number of Participants Who Returned to the QW Regimen After Switching to the Q2W Regimen|Participants could switch between regimens at the Investigator's judgment based upon safety, efficacy, and pharmacokinetic/pharmacodynamic data. The number of participants who switched from the QW to the Q2W regimen and thereafter returned to the QW regimen was reported with the reason for returning to the QW regimen.|From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)|ITT Population; only participants who switched from the QW to Q2W regimen were included.||participants|||Number
673536|NCT01662063|Secondary|Percentage of Participants Who Switched From the QW Regimen and Remained on the Q2W Regimen|Participants could switch between regimens at the Investigator's judgment based upon safety, efficacy, and pharmacokinetic/pharmacodynamic data. The percentage of participants who switched from the QW to the Q2W regimen and did not return to the QW regimen was calculated.|From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)|ITT Population. The results were presented for all participants to account for multiple switches between arms (i.e., participants who started in the Q2W arm could have switched to QW and then switched back to Q2W, making them analyzable for the outcome measure).||percentage of participants|||Number
673537|NCT01662063|Secondary|Number of Participants Who Switched From the QW Regimen and Remained on the Q2W Regimen|Participants could switch between regimens at the Investigator's judgment based upon safety, efficacy, and pharmacokinetic/pharmacodynamic data. The number of participants who switched from the QW to the Q2W regimen and did not return to the QW regimen was reported.|From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)|ITT Population. The results were presented for all participants to account for multiple switches between arms (i.e., participants who started in the Q2W arm could have switched to QW and then switched back to Q2W, making them analyzable for the outcome measure).||participants|||Number
673538|NCT01662063|Secondary|Percentage of Reasons Given for CCS Discontinuation|Use of concomitant medications, including CCS treatment, was recorded throughout the study. Any change in CCS therapy was documented and reported among those participants who received at least one CCS before the last dose of SC TCZ. The reasons for any CCS discontinuation >14 days were reported. More than one reason could be given for a single change in CCS therapy, and each participant could also change CCS therapy more than once. Therefore, the number of reasons could exceed the number of participants analyzed.|From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)|ITT Population; only participants with a CCS discontinuation >14 days were included.||percentage of reasons|Participants||Number
673539|NCT01662063|Secondary|Percentage of Reasons Given for CCS Dose Interruption|Use of concomitant medications, including CCS treatment, was recorded throughout the study. Any change in CCS therapy was documented and reported among those participants who received at least one CCS before the last dose of SC TCZ. The reasons for any CCS dose interruption ≤14 days were reported. More than one reason could be given for a single change in CCS therapy, and each participant could also change CCS therapy more than once. Therefore, the number of reasons could exceed the number of participants analyzed.|From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)|ITT Population; only participants with a CCS dose interruption ≤14 days were included. Results were only reported for the QW arm because no participants in the Q2W arm had a CCS dose interruption.||percentage of reasons|Participants||Number
673540|NCT01662063|Secondary|Percentage of Reasons Given for CCS Dose Reduction|Use of concomitant medications, including CCS treatment, was recorded throughout the study. Any change in CCS therapy was documented and reported among those participants who received at least one CCS before the last dose of SC TCZ. The reasons for any CCS dose reduction were reported. More than one reason could be given for a single change in CCS therapy, and each participant could also change CCS therapy more than once. Therefore, the number of reasons could exceed the number of participants analyzed.|From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)|ITT Population; only participants with a CCS dose reduction were included.||percentage of reasons|Participants||Number
673682|NCT01660672|Secondary|Toxicity Related to LVT|Toxicity including vomiting, aspiration, complications related to the NGT, laboratory parameters at 24 hours and 1 week post LVT administration, and an overall acute case fatality rate significantly above the consistent historical ward average for CM. Pk studies to evaluate LVT absorption and elimination in pediatric CM.|1 week|||participants|||Number
673541|NCT01662063|Secondary|Percentage of Participants With a CCS Dose Reduction, Interruption, or Discontinuation|Use of concomitant medications, including CCS treatment, was recorded throughout the study. Any change in CCS therapy was documented and reported among those participants who received at least one CCS before the last dose of SC TCZ.|From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)|ITT Population; only participants who received at least one CCS before the last dose of TCZ were included.||percentage of participants|||Number
673542|NCT01662063|Secondary|Number of Participants With a Corticosteroid (CCS) Dose Reduction, Interruption, or Discontinuation|Use of concomitant medications, including CCS treatment, was recorded throughout the study. Any change in CCS therapy was documented and reported among those participants who received at least one CCS before the last dose of SC TCZ.|From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)|ITT Population; only participants who received at least one CCS before the last dose of TCZ were included.||participants|||Number
673543|NCT01662063|Secondary|Percentage of Reasons Given for DMARD Discontinuation|Use of concomitant medications, including non-biologic DMARDs, was recorded throughout the study. Any change in DMARD therapy was documented and reported among those participants receiving at least one DMARD at Baseline. The reasons for any DMARD discontinuation were reported. More than one reason could be given for a single change in DMARD therapy, and each participant could also change DMARD therapy more than once. Therefore, the number of reasons could exceed the number of participants analyzed.|From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)|ITT Population; only participants with a DMARD discontinuation >60 days were included.||percentage of reasons|Participants||Number
673544|NCT01662063|Secondary|Percentage of Reasons Given for DMARD Dose Reduction or Interruption|Use of concomitant medications, including non-biologic DMARDs, was recorded throughout the study. Any change in DMARD therapy was documented and reported among those participants receiving at least one DMARD at Baseline. The reasons for any DMARD dose reduction/interruption ≤60 days were reported. More than one reason could be given for a single change in DMARD therapy, and each participant could also change DMARD therapy more than once. Therefore, the number of reasons could exceed the number of participants analyzed.|From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)|ITT Population; only participants with a DMARD dose reduction/interruption ≤60 days were included.||percentage of reasons|Participants||Number
673545|NCT01662063|Secondary|Percentage of Participants With a DMARD Dose Reduction, Interruption, or Discontinuation|Use of concomitant medications, including non-biologic DMARDs, was recorded throughout the study. Any change in DMARD therapy was documented and reported among those participants receiving at least one DMARD at Baseline.|From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)|ITT Population; only participants receiving at least one DMARD at Baseline were included.||percentage of participants|||Number
673546|NCT01662063|Secondary|Number of Participants With a Disease-Modifying Anti-Rheumatic Drug (DMARD) Dose Reduction, Interruption, or Discontinuation|Use of concomitant medications, including non-biologic DMARDs, was recorded throughout the study. Any change in DMARD therapy was documented and reported among those participants receiving at least one DMARD at Baseline.|From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)|ITT Population; only participants receiving at least one DMARD at Baseline were included.||participants|||Number
673547|NCT01662063|Secondary|Change From Baseline in SJC Score|Sixty-six joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination. The number of swollen joints was taken as the SJC score, where values may range from 0 to 66. The change from Baseline to each visit was calculated, where positive changes represent an increase in number of swollen joints.|Baseline to Weeks 12, 24, 36, 48, 60, 72, 84|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table."||swollen joints||Standard Deviation|Mean
673548|NCT01662063|Secondary|Swollen Joint Count (SJC) Score|Sixty-six joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination. The number of swollen joints was taken as the SJC score, where values may range from 0 to 66.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84|ITT Population; only those participants who provided evaluable data (n) were included in the analysis.||swollen joints||Standard Deviation|Mean
673549|NCT01662063|Secondary|Change From Baseline in TJC Score|Sixty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination. The number of tender joints was taken as the TJC score, where values may range from 0 to 68. The change from Baseline to each visit was calculated, where positive changes represent an increase in number of tender joints.|Baseline to Weeks 12, 24, 36, 48, 60, 72, 84|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table."||tender joints||Standard Deviation|Mean
673550|NCT01662063|Secondary|Tender Joint Count (TJC) Score|Sixty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination. The number of tender joints was taken as the TJC score, where values may range from 0 to 68.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84|ITT Population; only those participants who provided evaluable data (n) were included in the analysis.||tender joints||Standard Deviation|Mean
673551|NCT01662063|Secondary|Change From Baseline in SDAI Score|The SDAI was calculated using the SJC, TJC, Global Assessment of Disease Activity by the patient and by the physician according to separate VAS scores, and hsCRP level. For the SDAI formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The SDAI was calculated as the sum of the component scores, that is, SJC + TJC + VAS (participant) + VAS (physician) + hsCRP. Because the formula includes hsCRP, scores may theoretically range from 0 to infinity, where higher scores indicate increased disease activity. However, based upon normal hsCRP level within 1 mg/dL, scores would be expected to fall within ≤77 points. The change from Baseline to each visit was calculated, where positive changes represent an increase or worsening in disease activity.|Baseline to Weeks 12, 24, 36, 48, 60, 72, 84|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table."||units on a scale||Standard Deviation|Mean
673683|NCT01660672|Primary|Freedom From Seizure|Number of subjects free of seizure at 24 hours after initiation of treatment|24 hours|||individuals|||Number
673552|NCT01662063|Secondary|Simplified Disease Activity Index (SDAI) Score|The SDAI was calculated using the SJC, TJC, Global Assessment of Disease Activity by the patient and by the physician according to separate VAS scores, and high-sensitivity C-reactive protein (hsCRP) level. For the SDAI formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The SDAI was calculated as the sum of the component scores, that is, SJC + TJC + VAS (participant) + VAS (physician) + hsCRP. Because the formula includes hsCRP, scores may theoretically range from 0 to infinity, where higher scores indicate increased disease activity. However, based upon normal hsCRP level within 1 milligram per deciliter (mg/dL), scores would be expected to fall within less than or equal to (≤) 77 points.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table."||units on a scale||Standard Deviation|Mean
673553|NCT01662063|Secondary|Change From Baseline in CDAI Score|The CDAI was calculated using the SJC, TJC, and Global Assessment of Disease Activity by the patient and by the physician according to separate VAS scores. For the CDAI formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The CDAI was calculated as the sum of the component scores, that is, SJC + TJC + VAS (participant) + VAS (physician). Scores may range from 0 to 76, where higher scores indicate increased disease activity. The change from Baseline to each visit was calculated, where positive changes represent an increase or worsening in disease activity.|Baseline to Weeks 12, 24, 36, 48, 60, 72, 84|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table."||units on a scale||Standard Deviation|Mean
673554|NCT01662063|Secondary|Clinical Disease Activity Index (CDAI) Score|The CDAI was calculated using the SJC, TJC, and Global Assessment of Disease Activity by the patient and by the physician according to separate VAS scores. For the CDAI formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The CDAI was calculated as the sum of the component scores, that is, SJC + TJC + VAS (participant) + VAS (physician). Scores may range from 0 to 76, where higher scores indicate increased disease activity.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84|ITT Population; only those participants who provided evaluable data (n) were included in the analysis.||units on a scale||Standard Deviation|Mean
673555|NCT01662063|Secondary|Change From Baseline in DAS28 Score|The DAS28 was calculated using the SJC, TJC, ESR, and Global Assessment of Disease Activity by the participant according to VAS score. For the DAS28 formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The DAS28 was calculated as (0.56 × square root of TJC) + (0.28 × square root of SJC) + (0.7 × ln ESR) + (0.014 × VAS). Scores may range from 0 to 10, where higher scores indicate increased disease activity. The change from Baseline to each visit was calculated, where positive changes represent an increase or worsening in disease activity.|Baseline to Weeks 12, 24, 36, 48, 60, 72, 84|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table."||units on a scale||Standard Deviation|Mean
673556|NCT01662063|Secondary|Disease Activity Score Based on 28 Joints (DAS28) Score|The DAS28 was calculated using the Swollen Joint Count (SJC), Tender Joint Count (TJC), erythrocyte sedimentation rate (ESR), and Global Assessment of Disease Activity by the participant according to Visual Analog Scale (VAS) score. For the DAS28 formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-millimeter (mm) scale to a 10-point score. The DAS28 was calculated as (0.56 multiplied by [×] square root of TJC) + (0.28 × square root of SJC) + (0.7 × log natural [ln] ESR) + (0.014 × VAS). Scores may range from 0 to 10, where higher scores indicate increased disease activity.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table."||units on a scale||Standard Deviation|Mean
673557|NCT01662063|Secondary|Percentage of Participants Who Correctly Administered All SC TCZ Doses|Compliance was assessed using drug dispensing logs, diary cards kept by the participant, and return records, as reviewed by the Investigator at regular visits. Total compliance up to the end of treatment was defined as the percentage of participants who correctly administered all scheduled doses of SC TCZ. Correct administration was defined as proper injection technique, injection of the correct amount (162 mg), device not left at room temperature for greater than (>) 8 hours, and absence of other medication errors.|From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)|Intent-to-Treat (ITT) Population: All participants who received at least one dose of study medication and had at least one post-dose efficacy assessment.||percentage of participants|||Number
673558|NCT01662063|Primary|Percentage of Participants With a Positive Anti-TCZ Antibody Assay Post-Baseline|Blood samples were collected to test for the presence of antibodies to TCZ. The percentage of participants with a positive anti-TCZ antibody assay was calculated. Positive assay results obtained post-Baseline were further investigated via confirmation assay and a neutralization assay.|From Week 12 up to 8 weeks after last dose; assessed at Weeks 12, 24, 36, 48, 60, 72, 84, 96; and up to 8 weeks after last dose (up to 2 years overall)|Safety Population; only participants with a valid assay at Screening were included.||percentage of participants|||Number
673559|NCT01662063|Primary|Percentage of Participants With a Positive Anti-TCZ Antibody Assay at Baseline|Blood samples were collected to test for the presence of antibodies to TCZ. The percentage of participants with a positive anti-TCZ antibody assay was calculated.|Baseline|Safety Population; only participants with a valid assay at Screening were included.||percentage of participants|||Number
673560|NCT01662063|Primary|Percentage of Participants With a Positive Anti-TCZ Antibody Assay at Any Timepoint|Blood samples were collected to test for the presence of antibodies to TCZ. The percentage of participants with a positive anti-TCZ antibody assay was calculated.|From Baseline to 8 weeks after last dose; assessed at Baseline; Weeks 12, 24, 36, 48, 60, 72, 84, 96; and up to 8 weeks after last dose (up to 2 years overall)|Safety Population; only participants with a valid assay at Screening were included.||percentage of participants|||Number
674120|NCT01654276|Primary|Ambulatory Systolic Blood Pressure|Systolic BP by ambulatory blood pressure monitor.|6 months|||mmHg||Standard Deviation|Mean
674121|NCT01654276|Primary|Serum Creatinine||6 months|||mg/dl||Standard Deviation|Mean
673561|NCT01662063|Primary|Percentage of Participants With at Least One SAE|AEs were monitored throughout treatment. AEs were defined as any untoward medical occurrence in a participant who received study drug regardless of causality. SAEs were defined as AEs that were fatal or life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, manifested as a congenital anomaly/birth defect, were medically significant, or required intervention to prevent any of the aforementioned outcomes. The percentage of participants with at least one SAE regardless of treatment relationship was calculated.|From Baseline to 8 weeks after last dose; assessed continuously during treatment (up to 96 weeks) and up to 8 weeks after last dose (up to 2 years overall)|Safety Population.||percentage of participants|||Number
673562|NCT01662063|Primary|Number of Participants With at Least One Serious Adverse Event (SAE)|Adverse events (AEs) were monitored throughout treatment. AEs were defined as any untoward medical occurrence in a participant who received study drug regardless of causality. SAEs were defined as AEs that were fatal or life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, manifested as a congenital anomaly/birth defect, were medically significant, or required intervention to prevent any of the aforementioned outcomes. The number of participants with at least one SAE regardless of treatment relationship was reported.|From Baseline to 8 weeks after last dose; assessed continuously during treatment (up to 96 weeks) and up to 8 weeks after last dose (up to 2 years overall)|Safety Population.||participants|||Number
673563|NCT01662024|Secondary|Waist Circumference Loss (cm)|Data for the following effectiveness outcome measures (variables) will be collected and analyzed relative to baseline: Waist Circumference Loss (cm)|12 Months|||cm||Full Range|Mean
673564|NCT01662024|Secondary|BMI Loss (kg/m^2)|Data for the following effectiveness outcome measures (variables) will be collected and analyzed relative to baseline: BMI Loss (kg/m^2)|12 Months|||kg/m^2||Full Range|Mean
673565|NCT01662024|Secondary|Percentage of Total Body Weight Loss|Data for the following effectiveness outcome measures (variables) will be collected and analyzed relative to baseline: Percentage of Total body weight loss|12 Months|||Percentage of total weight lost||Full Range|Mean
673566|NCT01662024|Secondary|Durability|Data will be collected on the durability of the plications by evaluating the remaining plications at the 12 month endoscopy, compared to the number of plications placed at the time of procedure.|12 months|Endoscopies were performed at 12 months but it was difficult to count the number of plications still intact as originally planned.|||||
673567|NCT01662024|Secondary|Percent Excess Weight Loss|Data for the following effectiveness outcome measures (variables) will be collected and analyzed relative to baseline: Percent excess weight loss|12 Months|||Percentage of excess weight lost||Full Range|Mean
673568|NCT01662024|Primary|Evaluation of Technical Feasibility of the Procedure|Technical success was defined by placement of at least 8 running sutures and 4 interrupted sutures in the gastric body with exclusion of the lateral stomach.|Day 0 - Procedure Day|||Sutures||Full Range|Mean
673569|NCT01662024|Primary|Number of Participants With Adverse Events|Perioperative adverse events were defined as those occurring during the procedure or the post-procedure observation period. Postoperative adverse events were defined as occurring during the first three days after the procedure. Delayed adverse events were defined as occurring on the fourth post-procedure day or afterwards.|12 months|||Participants|||Count of Participants
673570|NCT01661972|Secondary|Median Survival|Time in months from the start of study treatment to date of death due to any cause. Median survival was estimated using a Kaplan-Meier curve and is the time point at which 50% of patients remain alive.|Subjects will be followed until death which is estimated to be on average 6 months - 1 year after coming off protocol therapy|Patients enrolled in Phase 2 were included in the analysis||months||95% Confidence Interval|Median
673571|NCT01661972|Secondary|Response Rate|The percentage of patients for whom the best overall response is complete response (CR) or partial response (PR). A CR occurs when all lesions disappear; whereas, a PR is indicated when there is at least a 30% decrease in the sum of the longest diameters (LD) of the target lesion. A PD (progressive disease) occurs when there is at least a 20% increase in the sum of the LD relative to the smallest sum LD recorded since treatment is initiated. Disease is considered stable if there is no response and no PD. All patients were assigned a best response for inclusion in this calculation in accordance with the protocol.|approximately every 9 weeks and/or restaging, through study completion|All evaluable Phase 2 patients. 5 patients were not evaluable for response and were not included in the analysis.||percentage of participants||95% Confidence Interval|Number
673572|NCT01661972|Primary|Median Progression Free Survival (PFS)|Time in months from the start of study treatment to the date of first progression (PD) according to the RECIST criteria, or death due to any cause. Per RECIST criteria, a PD is indicated when there is at least a 20% increase in the sum of the longest diameters from target lesions relative to the smallest sum recorded since treatment is initiated. Median PFS was estimated using a Kaplan-Meier curve, and is the time at which 50% of patients remain alive without disease progression.|approximately 5 months|Patients enrolled in Phase 2 were included in the analysis||Months||95% Confidence Interval|Median
673573|NCT01661972|Primary|Number of Dose-Limiting Toxicities (Phase 1)|"Number of patients experiencing a dose-limiting toxicity in each cohort.
A dose-limiting toxicity is defined as Grade 4 neutropenia, thrombocytopenia or anemia or grade 3 neutropenia or thrombocytopenia lasting over 7 days Grade 3 thrombocytopenia associated with bleeding Febrile Neutropenia Nausea/Vomiting or Diarrhea ≥ grade 3 and lasting ≥ 4 days despite adequate supportive measures Grade ≥ 3 Bilirubin, ALT or AST > 7 days Other non-hematologic toxicity ≥ grade 3 excluding alopecia, anorexia, fatigue, hypertension, isolated lab abnormalities (not clinically significant) and/ rare, idiosyncratic reactions to any of the study drugs. Anorexia, fatigue and hypertension will be considered as DLT only if they reach grade 4 or are considered unmanageable Treatment delay of ≥ 14 days for cycle 2 due to unresolved toxicity Treatment-related death or clinically significant,treatment-related hospitalization"|28 days|||Participants|||Count of Participants
673708|NCT01660230|Secondary|Total Clearance (CL) of 3K3A-APC by Non-compartmental Analysis|Single-dose cohorts|0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post‐dose|All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.||mL/h||Standard Deviation|Mean
673574|NCT01661972|Primary|Recommended Phase II Dose (RPTD) for the Capecitabine and Aflibercept Doublet Combination|Phase 1 of this study will be the dose escalation component to determine safety and the Recommended Phase II dose (RPTD) for the capecitabine plus aflibercept combination. Cohort 1 will receive 850mg/m2 capecitabine and 6mg/kg aflibercept. If less than 2 of 6 patients experience a dose limiting toxicity in Cohort 1, then the next patients will be enrolled in Cohort 2 at 1000mg/m2 capecitabine and 6mg/kg aflibercept. RPTD is determined by the number of dose limiting toxicities (Primary obj 2 for Phase I).|RPTD for the study will be determined at the completion of Phase I; up to 1 year|||mg/m2|||Number
673575|NCT01661933|Secondary|Serum Anti-tissue Transglutaminase Antibodies Measured as International Units/mL (IU/mL)|The trial was extended with pre-trial and mid-trial anti-tTG antibody levels used to compare with the post-trial levels. Anti-tTG is a serological measure of tissue transglutaminase-2 antibodies. In active celiac disease, levels are increased. In treated disease, levels are low (normal cut-off was <15 IU/mL). A significant increase compared to baseline in tTG can be expected 2 weeks after consuming 3g of gluten daily for 2 weeks in people with celiac disease who have been maintaining a gluten-free diet, but who are not taking other treatment.|Anti-tTG IU/mL levels pre-trial, mid-trial and after 3 gram/day gluten challenge|2 of 12 participants did not progress past baseline micro-challenge, 2 of 10 participants did not progress past low-dose challenge.||International Units/mL||95% Confidence Interval|Mean
673576|NCT01661933|Secondary|Number of Participants With 2 Points Increase in Marsh Score Post GC-1g|The Marsh score is a defined but qualitative assessment assigned a value to allow for comparison. The scores were evaluated by consensus between the primary (chief) investigator and the study pathologist. The Marsh score was graded 0, 1, 2, 3A (assigned-4), 3B (-5) and 3C (-6); rage 1-6 with normal=0 and severe inflammation=6. Because the scoring is vulnerable to artefact, only a 2-point shift was regarded as a significant intra-individual change. The scores were graded after week-36 on biopsies de-identified shuffled. An upward shift was interpreted to reflect a significant worsening of gluten-associated inflammation. The comparison reported evaluated changes from baseline (week-24) to post-low-dose gluten challenge (week-24; GC-1g). The objective for using the Marsh score was to identify individuals who might have experienced a severe worsening in pathology due to GC-1g that might not be reflected in the Vh:Cd group analysis.|Longitudinal change between week-24 and week-36|The outcome score was the number with a 2-point increase in Marsh 3 score post GC-1g.||participants|||Number
673577|NCT01661933|Secondary|Intraepithelial Lymphocyte Count|Biopsies were fixed in neutral buffered formalin, processed and carefully orientated and embedded in paraffin wax. Sections (3 µm) were stained with anti-CD3. All slides were de-identified and graded by Dr John Croese. The IEL percentages were measured on 2 or more randomly selected well-orientated villi. The null hypothesis is that hookworm infection will not protect against mucosal IEL influx following 12-week exposure to gluten in celiac disease.|Week-24 and -36|||Percentage of epithelial cells||95% Confidence Interval|Mean
673578|NCT01661933|Primary|Duodenal Villus Height:Crypt Depth|Biopsies were fixed in neutral buffered formalin, processed and carefully orientated and embedded in paraffin wax. Sections (3 µm) were stained with H&E. Slides from both time-points were de-identified, shuffled and graded by Dr John Croese after which results from poorly orientated slides were verified by Dr Andrew Clouston. The Vh:Cd ratios were measured on 5 randomly selected well-orientated sites. The null hypothesis is that hookworm infection will not protect against mucosal damage following 12-week exposure to gluten in celiac disease.|Week -24 to -36|All 10 of 12 participants who completed micro-challenge successfully progressed and completed low-dose challenge.||Ratio||95% Confidence Interval|Mean
673579|NCT01661881|Secondary|Autologous Stem Cell Transplant (ASCT) Rate|ASCT rate is the proportion of patients who completed therapy and proceeded to autologous stem cell transplant (ASCT)|All patients were followed for continuation to ASCT upon completion of induction therapy. Patients usually proceed to ASCT within 3 months of completing induction.|||proportion of participants||90% Confidence Interval|Number
673580|NCT01661881|Secondary|1 Year Progression-Free Survival|1-year progression-free survival is the probability of patients remaining alive and progression-free at 1 year from study entry estimated using Kaplan-Meier methods. Disease progression was based on the International Working Group (IWG) Criteria (Cheson et al, 1999).|Disease was assessed after three- and six-cycles of therapy and in long-term follow-up per standard practice every 6 months until the earliest of relapse, death or 5 years. Median follow-up in this study cohort was 13 months.|The analysis dataset is comprised of all enrolled patients.||probability||90% Confidence Interval|Number
673581|NCT01661881|Primary|Complete Remission (CR) Rate After 6 Cycles|The CR rate is defined as the proportion of patients who after 6 cycles of therapy achieve complete remission based on the International Working Group (IWG) Criteria (Cheson et al, 1999), using CT scans. CR or CRu (CR unconfirmed) by CT scans was defined by standard IWG criteria, ie resolution of all abnormal adenopathy and organomegaly, and clearance of marrow disease when present at baseline.|Disease was assessed after three- and six-cycles of therapy, up to approximately 25 weeks. All patients completed 6 cycles of therapy with a cycle duration of 28 days.|The analysis dataset is comprised of all enrolled patients.||proportion of participants||90% Confidence Interval|Number
673582|NCT01661790|Other Pre-specified|Quantitative RT-PCR(Reverse Transcription-Polymerase Chain Reaction) for VEGF-A(Vascular Endothelial Growth Factor A)||before intrapleural administration||||||
673583|NCT01661790|Secondary|Qualify of Life (QoL)||baseline to biweekly,until death||||||
673584|NCT01661790|Secondary|Adverse Reactions||Up to 1 month after the last treatment||||||
673585|NCT01661790|Secondary|Overall Survival (OS)||randomization to four weeks,until death||||||
673586|NCT01661790|Secondary|Median Progression Free Survival (PFS)||baseline to biweekly,until disease progression||||||
673587|NCT01661790|Primary|"Number of Participants With Complete Response and Partial Response"|Response assessed by type-B ultrasonic tests; Complete remission (CR) was considered when the accumulated fluid had disappeared and was stable for at least four weeks; partial remission (PR) was considered when >50% of the accumulated fluid had disappeared, symptoms had improved, and the remaining fluid had failed to increase for at least four weeks; The total efficiency ORR was calculated by taking the sum of CR+PR|from randomization, This treatment was given every two weeks,responses were made by biweekly|||participants|||Number
674122|NCT01654276|Primary|Serum Uric Acid||6 months|||mg/dl||Standard Deviation|Mean
674123|NCT01654276|Primary|BMI||6 months|||kg/m^2||Standard Deviation|Mean
673588|NCT01661621|Secondary|The International Prostate Symptom Score (IPSS) Quality of Life (QoL) Score After the Treatment Day|"Efficacy:
Using the the the International Prostate Symptom Score (IPSS) quality of life (QoL) score to compare the efficacy in Group 1 and Group 2 from baseline to 1month.
The IPSS quality of life question score on a 7-point scale ranging from 0 Delighted to 6 Terrible.
IPSS-QoL ranges 0 to 6 (Delighted to Terrible)
Safety:
Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness"|Baseline and 1 month|||units on a scale||Standard Deviation|Mean
673589|NCT01661621|Secondary|The IPSS Subscore (IPSS Storage) Questionnaires After the Treatment Day|"Efficacy:
Using the the IPSS subscore (IPSS Storage) to compare the efficacy in Group 1 and Group 2 from baseline to 1 month.
The IPSS subscore (IPSS Storage) is a 3 symptom questions. The symptom score have 6-point scale ranging from 0 Not at all to 5 Almost always. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom.
The total IPSS Storage score can therefore range from 0 to 15 (asymptomatic to very symptomatic).
Safety:
Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness"|Baseline and 1 month|||units on a scale||Standard Deviation|Mean
673590|NCT01661621|Secondary|The IPSS Subscore (IPSS Voiding) Questionnaires After the Treatment Day|"Efficacy:
Using the the IPSS subscore (IPSS Voiding) questionnaires to compare the efficacy in Group 1 and Group 2 from baseline to 1 month.
The IPSS subscore (IPSS Voiding) questionnaires is a 4 symptom questions. The symptom score have 6-point scale ranging from 0 Not at all to 5 Almost always. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom.
The total IPSS Voiding score can therefore range from 0 to 20 (asymptomatic to very symptomatic).
Safety:
Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness"|Baseline and 1 month|||units on a scale||Standard Deviation|Mean
673591|NCT01661621|Secondary|The Postvoid Residual Volume (PVR) After the Treatment Day|"Efficacy:
Net change used the the postvoid residual volume (PVR) in Group 1 and Group 2 from baseline to 1 month.
Safety:
Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness"|Baseline and 1 month|||mL||Standard Deviation|Mean
673592|NCT01661621|Secondary|The Voided Volume After the Treatment Day|"Efficacy:
Net change used the the voided volume in Group 1 and Group 2 from baseline to 1 month.
Safety:
Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness"|Baseline and 1 month|||mL||Standard Deviation|Mean
673593|NCT01661621|Secondary|The Maximum Flow Rate (Qmax) After the Treatment Day|"Efficacy:
Net change used the the maximum flow rate (Qmax) in Group 1 and Group 2 from baseline to 1 month.
Safety:
Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness"|Baseline and 1 month|||mL/s||Standard Deviation|Mean
673594|NCT01661621|Secondary|The International Prostate Symptom Score (IPSS) Questionnaires After the Treatment Day|"Efficacy:
Using the total International Prostate Symptom Score (IPSS) to compare the efficacy in Group 1 and Group 2 from baseline to 1 month.
The International Prostate Symptom Score (IPSS) is an 7 symptom questions including 4 voiding questions (IPSS-voiding), 3 storage questions (IPSS-Storage) The symptom score have 6-point scale ranging from 0 Not at all to 5 Almost always.
Total IPSS score = IPSS-voiding + IPSS-Storage Rang = 0 to 35 (asymptomatic to very symptomatic). Mild = 0 to 7; Moderate = 8 to 19; Severe = 20 to 35
Safety:
Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness"|Baseline and 1 month|||units on a scale||Standard Deviation|Mean
673595|NCT01661621|Primary|The Global Response Assessment (GRA) After the Treatment Day|"Efficacy Using global response assessment (GRA) to compare the efficacy in Group 1 and Group 2 from baseline to 1month.
The global response assessment on a 6-point scale ranging from 1 No problems at all to 6 Many severe problems.
Changes of the global response assessment (GRA) improved or reduction by 1 points.
Change = Baseline minus Month 1 value
Safety:
Systemic adverse events such as difficult urination, dry mouth, dry eye, blurred vision, constipation, dizziness or general weakness"|1 month after initial treatment|||participants|||Number
673596|NCT01661270|Secondary|Percentage of Participants With Objective Response|Objective response rate was defined as the proportion of participants with confirmed complete response (CR) or confirmed partial response (PR), as assessed by Investigators and the IRC according to RECIST 1.0 criteria, relative to the total number of participants in the relevant analysis population. Complete Response (CR): disappearance of all target and non-target lesions and no new lesions. Partial Response (PR): At least a 30% decrease in the size of target lesions with no progression of non-target lesions and no new lesions, or, the disappearance of all target lesions but persistence of 1 or more non-target lesions not qualifying for either CR or progressive disease (PD) and no new lesions.|26.6 months|ITT population.||percentage of participants||95% Confidence Interval|Number
673597|NCT01661270|Secondary|Overall Survival (OS)|OS was defined as the time interval from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, survival time was censored at the earliest between the last date of the participants was known to be alive and the study cut-off date. Analysis was performed by Kaplan-Meier method.|31.6 months|ITT population.||months||95% Confidence Interval|Median
673598|NCT01661270|Primary|Progression-free Survival (PFS)|PFS was defined as the time interval from the date of randomization to the date of first observation of either tumor progression or death due to any cause. Tumor assessment was performed by Independent Review Committee (IRC) as per response evaluation criteria in solid tumors (RECIST) version 1.0. Progression was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study or absolute increase and at least 5 mm, progression of existing non-target lesions, or presence of new lesions. PFS was calculated by Kaplan-Meier estimates.|26.7 months|Intent-to-Treat (ITT) population included all randomized participants.||months||95% Confidence Interval|Median
673614|NCT01661140|Secondary|Percentage of Participants With Improvement in Physical Function Using 12-item Short Form Health Survey [SF-12]) at Week 60 and 72|Quality of life questionnaire (SF-12) scores were computed using the scores of 12 questions and ranged from 0 to 100, where a 0 score indicated the lowest level of health measured by the scales and 100 indicated the highest level of health. Improvement was defined as a decrease from Week 24 to Week 60 and 72. Reported is the percentage of subjects with an improvement in SF-12 score.|Randomization (Week 24), Week 60, 72|ITT population included all randomized participants.||percentage of participants|||Number
673599|NCT01661205|Secondary|Change in AF Based on AF Symptoms Checklist Frequency and Severity Scores|"Change in Atrial Fibrillation Symptom Checklist Frequency and Severity Scores. This is reported as change from Baseline.
This scale has 16 items to assess frequency of occurrence on a scale: Never; Rarely; Sometimes; Often; Always. These rating correspond to numerical values of: 1, 2, 3, 4, and 5, respectively. AF Frequency range from 0 to 80 . Higher scores indicating greater symptomatology.
The same items are also used to assess severity on a scale: Mild; Moderate; Severe. Corresponding to 1, 2, and 3, respectively. AF Severity score range from 0 to 48. Higher scores indicating greater symptomatology.
Negative change from baseline compared to 12-months represents an improvement in AF symptomatology ."|12 month follow-up|||percentage of from baseline||Standard Deviation|Mean
673600|NCT01661205|Secondary|Number of Subjects With Direct Current (DC) Cardioversion||12 month follow-up|||Participants|||Count of Participants
673601|NCT01661205|Secondary|Number of Subjects With Reinterventions||12 month follow-up|||Participants|||Count of Participants
673602|NCT01661205|Secondary|Number of Subject Without Atrial Fibrillation|AF free with or without the need of antiarrhythmic drugs|6 and 12 month follow-up|||Participants|||Count of Participants
673603|NCT01661205|Secondary|Number of Subjects With Acute Procedure Success|"Defined as subject meeting all of the following criteria upon completion of the index-EP procedure
Isolation/block of all pulmonary veins (e.g. 4 of 4 veins);
Bi-directional cavotricuspid isthmus block;
Isolation of Box (i.e. no capture outside ablation lines connecting roof and floor lines between right-and-left pulmonary vein isolation lines);
Superior Vena Cava (SVC) isolation, if encircling SVC lesion performed."|Day 0|||Participants|||Count of Participants
673604|NCT01661205|Secondary|Number Subjects With Serious Device or Procedure Related Adverse Event Rate||12 month follow-up|||Participants|||Count of Participants
673605|NCT01661205|Primary|Number of Subjects With Absence of Atrial Fibrillation|Absence of atrial fibrillation (AF) at twelve month follow-up based on continuous 14 day ECG monitoring, while off all Class I and III antiarrhythmic therapy.|12 month follow-up|Subjects who are evaluable for primary efficacy endpoint, defined as all subjects in whom the minimally invasive staged epicardial/ endocardial ablation procedure is attempted and in whom the index-EP procedure and required post-procedure and 12 month follow-up efficacy endpoint assessment has been performed.||Participants|||Count of Participants
673606|NCT01661205|Primary|Number of Patients With Pre-specified Safety Endpoints Occurring in the First 30 Days Post-index Procedure or Hospital Discharge, Whichever is Longer.|Pre-specified events include: Death; Myocardial Infarction; Stroke or TIA; Excess bleeding; Pulmonary vein stenosis; atrio-esophagael fistula; phrenic nerve paralysis; Pericardial effusion; Embolisms.|30 days post-index procedure or hospital discharge|Number of treated subjects. Although 26 subjects were anesthetized only 25 subjects underwent epicardial procedure per protocol. Physician decided not to treat one of the anesthetized subjects. Another case was aborted and converted to open chest cardioversion. Twenty-four patients underwent endocardial catheter procedures.||Participants|||Count of Participants
673607|NCT01661179|Primary|Objective Response Rate Within the First 56 Weeks After the First Dose of Vandetanib|ORR is defined as the percentage of patients who have a confirmed CR (Disappearance of all target lesions) or PR (>=30% decrease in the sum of diameters of target lesions) prior to any evidence of progression as defined by RECIST V1.1. This percentage is calculated with only patients who had at least measurable lesion in the efficacy analysis set.|Sept 2012 to May 2014|All patients with post-baseline efficacy assessments||percentage of participants||95% Confidence Interval|Number
673608|NCT01661140|Secondary|Change in Productivity and Regular Daily Activities Affected by Rheumatoid Arthritis Assessed Using the WPAI-SHP|The WPAI-SHP questionnaire assesses work productivity and activity impairment. It is a patient-reported assessment regarding hours missed and hours worked at employment and degree to which a specified health problem affected work productivity and regular activities. It consists of 6 questions to assess the impact of a specific health problem on work productivity and on regular daily activities. Assessments were made using a visual analogue scale ranging from 0 to 10 where 0 = minimum impact and 10 = maximum impact.|Randomization (Week 24), Week 60, 72|Participants in the ITT population with available data at the respective time points were analyzed.||units on a scale||Full Range|Median
673609|NCT01661140|Secondary|Hours Actually Worked and Work Hours Missed Assessed Using the WPAI-SHP|The WPAI-SHP questionnaire assesses work productivity and activity impairment. It is a patient-reported assessment regarding hours missed and hours worked at employment and degree to which a specified health problem affected work productivity and regular activities. It consists of 6 questions to assess the impact of a specific health problem on work productivity and on regular daily activities. Reported here are hours actually worked, work hours missed due to rheumatoid arthritis (RA), work hours missed due to other reasons and the change from Week 24 for each of these parameters reported at Week 60 and Week 72.|Randomization (Week 24), Week 60, Week 72|Participants in the ITT population with available data were analyzed.||hours||Full Range|Median
673610|NCT01661140|Secondary|Number of Subjects Employed Assessed Using the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP)|The WPAI-SHP questionnaire assesses work productivity and activity impairment. It is a patient-reported assessment regarding hours missed and hours worked at employment and degree to which a specified health problem affected work productivity and regular activities. It consists of 6 questions to assess the impact of a specific health problem on work productivity and on regular daily activities.|Randomization (Week 24), Week 60, 72|ITT population included all randomized participants.||participants|||Number
673611|NCT01661140|Secondary|Percentage of Participants Able to Discontinue Methotrexate||Week 0 up to Week 60|Data were not collected for this outcome measure.|||||
673612|NCT01661140|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE was any adverse event that can be fatal, life threatening, requires long or prolong hospitalization, results in persistent or significant disability/incapacity, congenital anomaly or significant medical event in the investigator’s judgment.|Week 0 up to Week 72|Safety population included all the randomized participants.||participants|||Number
673613|NCT01661140|Secondary|Percentage of Participants With Anemia||Week 0 up to Week 72|Safety population included all the randomized participants.||percentage of participants|||Number
673615|NCT01661140|Secondary|Percentage of Participants With Improvement in Physical Function Using Functional Assessment of Chronic Illness Therapy – Fatigue [FACIT-F] at Week 60 and 72|The FACIT-fatigue assessment was a 13-item questionnaire with participants scoring each item on a 5-point scale (not at all; a little bit; somewhat; quite a bit and very much). The total score ranges from 0 to 65 and higher scores indicate more fatigue. Improvement was defined as a decrease from Week 24 to Week 60 and 72. Reported is the percentage of subjects with an improvement in total FACIT score.|Randomization (Week 24), Week 60, 72|ITT population included all randomized participants.||percentage of participants|||Number
673616|NCT01661140|Secondary|Percentage of Participants With Improvement in Physical Function Using Health Assessment Questionnaire [HAQ] at Week 60 and 72|The HAQ-disability index (DI) evaluates participant-reported quality of life using 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other common activities such as running errands and performing household chores and 20 questions. Each category contains multiple questions, which were answered using a 4-point scale from 0 to 3. The overall index score was an average of the individual item responses and may range from 0 to 3, where higher scores indicate more difficulty in daily living activities. Improvement was defined as a decrease from Week 24 to Week 60 and 72. Reported is the percentage of participants with an improvement in HAQ-DI score.|Randomization (Week 24), Week 60, 72|ITT population included all randomized participants.||percentage of participants|||Number
673617|NCT01661140|Secondary|Percentage of Participants Who Achieve Simplified Disease Activity Index (SDAI) Remission (SDAI < 3.3) at Week 60 and 72|Simplified Disease Activity Index (SDAI) was an index for measuring disease activity in RA. The index was calculated using the following formula: CDAI: SJC28 + TJC28 + PGA (10 cm VAS) + PhGA (10 cm VAS + C-Reactive Protein (CRP). VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity. Scores ranged from 0 to 86, with higher scores also indicating increased disease activity.|Randomization (Week 24), Week 60, 72|ITT population included all randomized participants.||percentage of participants|||Number
673618|NCT01661140|Secondary|Percentage of Participants Who Achieve Clinical Disease Activity Index (CDAI) Remission (CDAI < 2.8) at Week 60 and 72|Clinical Disease Activity Index (CDAI) was an index for measuring disease activity in RA. The index was calculated using the following formula: CDAI: SJC28 + TJC28 + patient global assessment of disease (PGA) 10 centimeter [cm] Visual Analog Scale [VAS] + physician global assessment of disease (PhGA) 10 cm VAS. VAS assessments involved a 10 cm horizontal scale from 'no disease activity' to 'maximum disease activity.' CDAI scores ranged from 0 to 76, with higher scores indicating increased disease activity.|Randomization (Week 24), Week 60, 72|ITT population included all randomized participants.||percentage of participants|||Number
673619|NCT01661140|Secondary|Percentage of Participants Who Achieve Change in Disease Activity Score (cDAS) >=1.2|The DAS28 index was calculated using the following formula: The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x patient global assessment of disease activity]. Participants who achieve cDAS28 >=1.2 score at weeks 60 and 72 were reported.|Week 60, 72|ITT population included all randomized participants.||percentage of participants|||Number
673620|NCT01661140|Secondary|Percentage of Participants Who Achieve DAS28 Remission (DAS28 < 2.6)|The DAS28 index was calculated using the following formula: The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x patient global assessment of disease activity]. Participants who achieve DAS28 remission score <2.6 at weeks 60 and 72 were reported.|Week 60, 72|ITT population included all randomized participants.||percentage of participants|||Number
673621|NCT01661140|Secondary|Percentage of Participants Who Achieve a Disease Activity Score In 28 Joints (DAS28) <= 3.2|The DAS28 index was calculated using the following formula: The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x patient global assessment of disease activity]. Participants who achieve score <=3.2 at weeks 60 and 72 were reported.|Week 60, 72|ITT population included all randomized participants.||percentage of participants|||Number
673622|NCT01661140|Secondary|Percentage of Participants Who Achieve Score of <=1 in Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Week 60 and 72|Percentage of participants who achieve score of =1 in TJC and SJC at week 60 and 72 were reported. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1; total was calculated by adding all the joints for a maximum score of 28. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1; total was calculated by adding all the joints for a maximum score of 28.|Week 60, 72|ITT population included all randomized participants.||percentage of participants|||Number
673623|NCT01661140|Secondary|Change From Baseline in Disease Activity Score In 28 Joints (DAS28) Score at Week 72|The DAS28 defined as a combined index for measuring disease activity in rheumatoid arthritis (RA). The index included swollen (range 0-28) and tender joint counts (TJC) (range 0-28), acute phase response Erythrocyte Sedimentation Rate (ESR), and general health status (range 1-100). The index was calculated using the following formula: The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x patient global assessment of disease activity]. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.|Randomization (Week 24), Week 72|ITT population included all randomized participants. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure.||units on a scale||Standard Deviation|Mean
673624|NCT01661140|Secondary|Change From Baseline in Disease Activity Score In 28 Joints (DAS28) Score at Week 60|The DAS28 defined as a combined index for measuring disease activity in rheumatoid arthritis (RA). The index included swollen (range 0-28) and tender joint counts (TJC) (range 0-28), acute phase response Erythrocyte Sedimentation Rate (ESR), and general health status (range 1-100). The index was calculated using the following formula: The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x patient global assessment of disease activity]. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.|Randomization (Week 24), Week 60|ITT population included all randomized participants. Here, number of participants analyzed signifies those participants who were evaluable for this end point.||units on a scale||Standard Deviation|Mean
673625|NCT01661140|Primary|Percentage of Participants Maintaining Previous Disease Activity (European League Against Rheumatism [EULAR] Response) From Week 24 (Time of Randomization) to Week 60|Response was determined using EULAR criteria based upon (Disease Activity Score In 28 Joints) DAS28 absolute scores at the assessment visit and the DAS28 reduction from the reference visit. Participants with a score lesser than or equal to (<=) 3.2 and reduction of greater than (>) 1.2 points were assessed as having a 'good' response. Participants with a score >3.2 with reduction of >1.2 points, or a score <=5.1 with reduction of >0.6 to <=1.2 points, were assessed as having a 'moderate' response. Participants with a score >5.1 with reduction of >0.6 to <=1.2 points, or any score with reduction <=0.6 points, were assessed as non-responders with response recorded as 'none.'|From randomization to Week 60|Intention to treat (ITT) population included all randomized participants.||percentage of participants|||Number
673626|NCT01661114|Secondary|Median Overall Survival of Previously Treated and Previously Untreated Patients|To assess the overall survival following treatment with gemcitabine, 5-FU and cisplatin.|1 year|Patients with metastatic adenocarcinoma of the pancreas or biliary tract, previously untreated or having received one cytotoxic regimen for advanced disease.||Months||95% Confidence Interval|Median
673627|NCT01661114|Primary|The Percentage of Untreated and Previously Treated Patients That Had a Partial Response to Treatment|"The primary objective of this clinical trial is to estimate the response rate to treatment with the triplet chemotherapy regimen of gemcitabine, infusional 5-FU, and cisplatin, in untreated and previously treated advanced pancreatic and biliary cancer patients.
Partial Response (PR) is defined as At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters."|28 days|Patients with metastatic adenocarcinoma of the pancreas or biliary tract, previously untreated or having received one cytotoxic regimen for advanced disease.||percentage of patients||95% Confidence Interval|Number
673628|NCT01661062|Primary|Correlation Coefficient for the Association Between Delivered Mean Parotid Dose and Salivary Flow Rate|Spearman rank-based correlation coefficients were calculated for the association between saliva flow rate and the delivered mean parotid doses at several timepoints (Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months).|24 months|36 parotid glands were evaluable from 18 patients at baseline, 34 parotid glands were evaluable at 3-6 months, 32 glands were evaluable at 12 months, 20 were evaluable at 18 months and 8 at 24 months.||correlation coefficient|||Number
673629|NCT01661062|Secondary|The Median Delivered Dose of Radiation to the Parotid Gland||7 weeks|||Gy||Full Range|Median
673630|NCT01661062|Secondary|Improvement of Image Quality|Use acquired data to further improve cone beam CT reconstruction techniques and image quality.|36 months||||||
673631|NCT01661062|Primary|Rate of Movement of Normal Tissue|The primary outcome measure of this study is to characterize patient-specific target and normal tissue movement.|approximately 7 weeks||||||
673632|NCT01660906|Other Pre-specified|Number of Participants With a Major Molecular Response (MMR) and MR 4.5 After Switching to Dasatinib|Molecular responses were assessed at 6 and 12 months after switching to dasatinib to determine if these baseline responses could be maintained. MR4.5, the number of treated participants with BCR-ABL transcripts ≤ 0.0032% (IS) at 6 and 12 months from the date of dasatinib initiation; MMR, Major Molecular Response = 3-log reduction in BCR-ABL gene transcripts from a standardized baseline.|6 and 12 months|All treated participants.||Participants|||Count of Participants
673633|NCT01660906|Secondary|The Percentage of Participants With at Least 1 Imatinib-related Grade 1 or Grade 2 Chronic Adverse Events (AEs) That Improved Without Worsening Within 3 Months of Switching to Dasatinib|Dasatinib treatment was administered and its impact on the Imatinib-related Grade 1/2 adverse events was assessed. The percentage of participants is based on the number that had pre-existing Imatinib-related AEs. Measure assesses the participants with reduction or improvement of at least 1 Imatinib-related Grade 1 or Grade 2 chronic AE, without a worsening of any Imatinib-related, chronic adverse events after Dasatinib treatment. The severity of an adverse event is ranked based on grades that range from 1 to 4. Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4= Potentially Life-threatening or disabling. Improved, AE grade reduced from Grade 2 to Grade 1. Worsened, Grade Increased. Confidence interval from Clopper-Pearson method.|3 months|All treated participants.||percentage of participants||95% Confidence Interval|Number
673634|NCT01660906|Secondary|Number of Participants With at Least 1 AE, Discontinuations Due to AE, Treatment-related AE, Serious Adverse Event (SAE), Treatment-related SAE, or Death as Outcome|SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Treatment-related=having certain, probable, possible, or missing relationship to study drug, dasatinib.|Date of first dose to 30 post last dose of study drug, an average of 3 years|All treated participants.||Participants|||Count of Participants
673635|NCT01660906|Secondary|Mean Change From Baseline in Patient Reported Quality of Life Measurements by The European Organization for Research and Treatment of Cancer - Quality of Life (QoL) Questionnaire (EORTC QLQ) Score After Switching to Dasatinib|The EORTC QLQ-C30 questionnaire is completed by study participants to assess quality of life through nine multi-item scales: five functional scales (physical, role, cognitive, emotional and social functioning); three symptom scales (fatigue, pain and nausea/vomiting); and a global health status/QoL scale. Six single-item scales are also included (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). All of the scales and single-item measures were evaluated at baseline and after switching to Dasatinib as an average raw score that was standardized by transformation, so that final scores were on a range in score from 0 to 100. A high score for a functional scale represents a healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale and single-item measures represents a high level of problematic symptomatology.|Baseline to 6, 12 months|All treated participants||units on a scale||Standard Deviation|Mean
673655|NCT01660802|Secondary|Average Change From Baseline in BCVA in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The average BCVA is calculated across study visits for each patient. A positive number change from baseline indicates an improvement and a negative number change from baseline indicates a worsening.|Baseline, 6 Months|Modified Intent-to-Treat: all randomized and treated patients||Letters Read Correctly||Standard Deviation|Mean
673636|NCT01660906|Secondary|Mean Change From Baseline in Patient Reported CML Symptom Severity and Interference by MD Anderson Symptom Inventory - Chronic Myeloid Leukemia (MDASI-CML) Score After Switching to Dasatinib|The MD Anderson Symptom Inventory Chronic Myeloid Leukemia (MDASI-CML) is a validated questionnaire completed by study participants to assess symptom severity and symptom interference on daily function. These categories are divided into 5 domain summary scores: Core Symptom Severity Score, Interference Score, Symptom Severity Score, CML-Specific Symptom Severity Score, and 5 Most Severe Symptom Score. Scores were evaluated at baseline and after switching to Dasatinib on a range from 1 to 10; 1=not present/did not interfere, 10=as bad as you can imagine/interfered completely.|Baseline to 3, 6, 12 months|All treated participants.||units on a scale||Standard Deviation|Mean
673637|NCT01660906|Primary|The Number of Imatinib-related Adverse Events (AEs) That Were Resolved, Improved, Remained Unchanged, or Worsened After 3 Months of Dasatinib Treatment|Dasatinib treatment was administered and its impact on the imatinib-related Grade 1/2 adverse events was assessed. The severity of an adverse event is ranked based on grades that range from 1 to 4. Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4= Potentially Life-threatening or disabling. Resolved, AE no longer present or resolution of imatinib-related chronic Grade 1 or Grade 2 non-hematologic AEs. Improved, AE grade reduced from Grade 2 to Grade 1. Unchanged, AE did not improve or worsen or no change in grade. Worsened, grade Increased.|3 months after switch to dasatinib|All treated participants.||adverse event(s)|||Number
673638|NCT01660893|Secondary|Absolute Maximum Change From Baseline in Heart Rate||from baseline to 120 minutes following drug administration|||bpm||Standard Deviation|Mean
673639|NCT01660893|Secondary|The Profile Over Time of Diastolic Blood Pressure||from baseline to 120 minutes following drug administration|||mmHg||Standard Deviation|Mean
673640|NCT01660893|Secondary|The Profile Over Time of Systolic Blood Pressure||from baseline to 120 minutes following drug administration|||mmHg||Standard Deviation|Mean
673641|NCT01660893|Secondary|Alcohol Sniff Test|The change from screening in the the distance from the nose (in centimeters) that a patient is able to detect the smell of an alcohol swab.|administered at approximately 24 hours after drug administration|||cm||Standard Deviation|Mean
673642|NCT01660893|Secondary|The Profile Over Time of Heart Rate||from baseline to 120 minutes following drug administration|||bpm||Standard Deviation|Mean
673643|NCT01660893|Secondary|Absolute Maximum Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure||from baseline to 120 minutes following drug administration|||mmHg||Standard Deviation|Mean
673644|NCT01660893|Secondary|Number of Participants With a Decrease From Baseline in Diastolic Blood Pressure Greater Than or Equal to 15 mm Hg and to a Value Lower Than 90 mm Hg||at any time within 120 minutes following drug administration|||Participants|||Count of Participants
673645|NCT01660893|Secondary|Number of Participants With an Increase From Baseline in Diastolic Blood Pressure Greater Than or Equal to 15 mm Hg and to a Value Higher Than 90 mm Hg||at any time within 120 minutes following drug administration|||Participants|||Count of Participants
673646|NCT01660893|Secondary|Number of Participants With a Decrease From Baseline in Systolic Blood Pressure Greater Than or Equal to 15 mm Hg and to a Value Lower Than 90 mm Hg||at any time within 120 minutes following drug administration|||Participants|||Count of Participants
673647|NCT01660893|Secondary|Number of Participants With an Increase From Baseline in Systolic Blood Pressure Greater Than or Equal to 25 mm Hg and to a Value Higher Than 160 mm Hg||at any time within 120 minutes following drug administration|||Participants|||Count of Participants
673648|NCT01660893|Secondary|Number of Participants With Heart Rate Lower Than 50 Bpm||at any time within 120 minutes following drug administration|||Participants|||Count of Participants
673649|NCT01660893|Secondary|Number of Participants With Heart Rate Higher Than 125 Bpm||at any time within 120 minutes following drug administration|||Participants|||Count of Participants
673650|NCT01660893|Secondary|Intraoral Soft-tissue Anesthesia (Yes/no)|Number of patients who reported no pain when incisive papilla and greater palatine foramen soft-tissue was tested with a probe|at 15 minutes with a 3 minute window|||Participants|||Count of Participants
673651|NCT01660893|Primary|Completion of the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic (Yes/no).||at 15 minutes with a 3 minute window|||Participants|||Count of Participants
673652|NCT01660815|Primary|Whole Body Radiation Dosimetry|Radiation dose values (millisieverts/megabecquerel [mSv/MBq]) were calculated for target organs, including the adrenals, brain, breasts, gall bladder wall, heart wall, kidneys, lower large intestine wall, liver, lungs, muscle, ovaries, osteogenic cells, pancreas, red marrow, skin, small intestine, spleen, stomach wall, testes, thymus, thyroid, total body, upper large intestine wall, urinary bladder wall, and uterus.|0-360 minutes|Analysis population includes the 6 subjects who completed the study and had valid imaging data for quantitative analysis.||mSv/MBq||Standard Deviation|Mean
673653|NCT01660802|Secondary|Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.|Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6|Modified Intent-to-Treat: all randomized and treated patients||Percentage of Patients|||Number
673654|NCT01660802|Secondary|Change From Baseline in BCVA in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. A decrease in the number of letters read correctly (negative number) means that vision has worsened.|Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6|Modified Intent-to-Treat: all randomized and treated patients||Letters Read Correctly||Standard Deviation|Mean
673677|NCT01660672|Other Pre-specified|Number of Participants Requiring AED During Admission|Number of participants who required AEDS during admission(including for breakthrough seizures in the LVT group) during admission.|7 days|||participants|||Number
673678|NCT01660672|Other Pre-specified|Number of Subjects Exposed to Phenobarbitone Prior to Enrollment|Pre-enrollment exposure to phenobarbitone may impact LVT efficacy, and analysis base on this characteristic will be evaluated.|0 hour|||participants|||Number
673656|NCT01660802|Primary|Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The numbers of patients with at least a 15 or more letter improvement in BCVA in the study eye are presented.|Baseline, 6 Months|Modified Intent-to-Treat: all randomized and treated patients||Patients|||Number
673657|NCT01660763|Primary|Time-weighted Summed Pain Intensity Difference (SPID) Over the 48-hour Study Period (SPID48).|"SPID-48 is the sum of the pain intensity difference (PID) over the 48 hour time period. A pain intensity score of 0 (no pain) to 10 (worse possible pain) is obtained before starting the study and throughout the 48 time period. The pain score at each assessment time is subtracted from the baseline pain score to provide the total sum score or SPID-48. A higher SPID-48 is better and indicates a reduction in pain intensity compared to the baseline score. Range of SPID48 scores were -239 to 417.
Time-weighted SPID48 = ∑ [T(i) – T(i-1)] x PID(i), where T(0) = Time 0 (baseline), T(i) is the scheduled or unscheduled assessment time, and PID(i) is the PID score at time i for i=0 to 48 hours"|48 hours|||Units on a scale||Standard Error|Least Squares Mean
673658|NCT01660737|Secondary|Change of Symptom Tearing Eyes (Pre-post)|Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)|Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)|||participants|||Number
673659|NCT01660737|Secondary|Change of Symptom Headache (Pre-post)|Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)|Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)|||participants|||Number
673660|NCT01660737|Secondary|Change of Symtom Fatigue / Tiredness|Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)|Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)|||participants|||Number
673661|NCT01660737|Secondary|Change of Symptom Rhinitis (Pre-post)|Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)|Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)|||participants|||Number
673662|NCT01660737|Secondary|Change of Symptom Sneezing (Pre-post)|Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)|Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)|||participants|||Number
673663|NCT01660737|Secondary|Change of Symptom Bronchial Complaints (Pre-post)|Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)|Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)|||participants|||Number
673664|NCT01660737|Secondary|Change of Symptom Burning Eyes (Pre-post)|Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)|Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)|||participants|||Number
673665|NCT01660737|Secondary|Change of Symptom Itching Eyes (Pre- Post)|Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)|Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)|||participants|||Number
673666|NCT01660737|Secondary|Change of Symptom Dry Eyes (Pre- Post)|Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)|Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)|||participants|||Number
673667|NCT01660737|Secondary|Numerical Rating Scale Well Beeing (Pre- Post)|Influence of allergy on the general well-being (scale from 0-no influence to 10 strong influence)|Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)|||participants|||Number
673668|NCT01660737|Primary|Tolerability|Request of Tolerability using a 2-stage scale (very good tolerability, bad tolerability)|app. 4 weeks after baseline (treatment app. for 4 weeks)|||participants|||Number
673669|NCT01660737|Primary|Efficacy of Pascallerg|Request of Efficacy using a 4-stage scale (very good efficacy, good efficacy, moderate efficacy, no efficacy)|appr. 4 weeks after baseline (after appr. 4 weeks of treatment)|||participants|||Number
673670|NCT01660698|Primary|Comparison of Th2 Cytokines (IL-5) Between Placebo and Probiotic Groups at Baseline (Beginning of Product Intake), 4 Weeks (Mid Period of Product Intake) and 8 Weeks (End of Product Intake)|A maximum of 10 ml heparinized, venous blood will be collected during Visit 1, 2 and 3. Whole blood cells will be cultured for 120 hours (5 days) with culture medium with different stimuli. Cell supernatants will be collected and analyzed for different cytokines.|0 (baseline), 1, and 2 months|||ng/mL||Standard Deviation|Mean
673671|NCT01660698|Secondary|Change From Baseline in Basophil Activation at 8 Weeks in ex Vivo Stimulated Whole Blood Cells||8 weeks||||||
673672|NCT01660698|Secondary|Change From Baseline in Immunoglobulin Levels in Serum Between Treatment Groups||8 weeks||||||
673673|NCT01660698|Secondary|Change From Baseline in Pro-inflammatory Cytokines (TNF-alpha, IL-1beta) at 8 Weeks in ex Vivo Stimulated Whole Blood Cells||8 weeks||||||
673674|NCT01660698|Secondary|Comparison Between Probiotic and Placebo at Baseline (Beginning of Product Intake), 1 Month and 2 Months (End of Product Intake)|TNSS Questionnaire were distributed at every visit (1 questionnaire for every week). The scored questionnaire were collected at subsequent visits. The symptom scores for nasal congestion, runny nose, nasal itching and sneezing were expressed as weekly sums (scale 0-3 for each symptom). The TNSS was the weekly sum for all the symptoms (scale 0-12). The TNSS data were analyzed as both monthly averages (at V2 and V3 compared to baseline V1) and weekly TNSS scores. Monthly TNSS scores were calculated as average over the 4 weeks preceding the visits. The higher the score is, the worse the outcome is.|Measures at baseline, 1, and 2 months|||units on a scale||Standard Deviation|Mean
673675|NCT01660698|Primary|Comparison of Th2 Cytokines (IL-13) Between Placebo and Probiotic Groups at Baseline (Beginning of Product Intake), 4 Weeks (Mid Period of Product Intake) and 8 Weeks (End of Product Intake)|A maximum of 10 ml heparinized, venous blood will be collected during Visit 1, 2 and 3. Whole blood cells will be cultured for 120 hours (5 days) with culture medium with different stimuli. Cell supernatants will be collected and analyzed for different cytokines.|0 (baseline), 1 and 2 months|||ng/mL||Standard Error|Mean
673676|NCT01660672|Other Pre-specified|Mean Time to Return to a BCS Score Greater Than or Equal to 4|Mean time from admission to a BCS score greater than or equal to 4. The BCS (Blantyre Coma Scale) is a 0-5 scale measuring motor response, verbal response and eye movement assessing the severity of coma in children with cerebral malaria. Lower scores correspond to more profound coma.|7 days|||hours||Full Range|Mean
673684|NCT01660334|Secondary|Number of Participants With Clinical Response of Cure at the Test-of-Cure(TOC) Visit.|"The primary endpoint was the efficacy ratio (number of effective cases/number of evaluable cases for efficacy assessment) among the cohort comprising the participants for efficacy analysis.
Clinical response of cure was assessed comprehensively by physicians in the three categories, which were effective, ineffective, and not evaluable, based on the clinical symptoms, imaging diagnosis and endoscopy, fungal tests, and serological tests."|16 weeks|The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
673685|NCT01660334|Primary|Number of Participants With Serious Treatment Related Adverse Events.|Adverse events mean all unfavorable events that occur in participants after administration of Voriconazole, irrespective of causal relationship to Voriconazole (including clinically problematic abnormal changes in laboratory test values). Serious adverse events were defined as those including death, fatal risk, hospitalization or prolongation of hospitalization period, continuous dysfunction, those causing malformation, and serious ones like the above-cited events. Treatment related Adverse Events were evaluated in company with the causal relationship to Voriconazole.|16 weeks|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.||participants|||Number
673686|NCT01660321|Primary|AUC (0-12) for Benzyl Alcohol|Area under the plasma concentration versus time curve (AUC) of benzyl alcohol in Natroba (spinosad) Topical Suspension, 0.9%.|Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.|Since the only benzyl alcohol concentrations above Limit of Quantitation (LOQ) (1.0 μg/mL) were for 1 sample each for 4 subjects and 2 non-consecutive samples for 2 subjects, AUC (0-12) was not summarized.||μg*hr/mL|||Number
673687|NCT01660321|Primary|Tmax for Benzyl Alcohol|The time after administration of Natroba (spinosad) Topical Suspension, 0.9% when the maximum plasma concentration is reached for benzyl alcohol.|Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.|Per Protocol||hours||Full Range|Median
673688|NCT01660321|Primary|Cmax for Benzyl Alcohol|Peak Plasma Concentration of benzyl alcohol (above Limit of Quantitation (1.0 μg/mL) in Natroba (spinosad) Topical Suspension, 0.9%.|Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.|Per Protocol||μg/mL||Standard Deviation|Mean
673689|NCT01660321|Primary|AUC (0-12) for Spinosyn D|Area under the plasma concentration versus time curve (AUC) of Spinosyn D in Natroba (spinosad) Topical Suspension, 0.9%.|Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.|Per Protocol. For all but 1 subject (Subject 02-202), all spinosyn A and spinosyn D concentrations were Below Quantification Level (BQL) or < 3.0 ng/mL for all samples. Therefore, Cmax, Tmax, and AUC 0-12 were not summarized.||ng* hr/mL|||Number
673690|NCT01660321|Primary|Tmax for Spinosyn D|The time after administration of Natroba (spinosad) Topical Suspension, 0.9% when the maximum plasma concentration is reached for Spinosyn D.|Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.|Per Protocol. For all but 1 subject (Subject 02-202), all spinosyn A and spinosyn D concentrations were Below Quantification Level (BQL) or < 3.0 ng/mL for all samples. Therefore, Cmax, Tmax, and AUC 0-12 were not summarized.||hours|||Number
673691|NCT01660321|Primary|Cmax for Spinosyn D|Peak Plasma Concentration of Spinosyn D in Natroba (spinosad) Topical Suspension, 0.9%|Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.|Per Protocol. For all but 1 subject (Subject 02-202), all spinosyn A and spinosyn D concentrations were Below Quantification Level (BQL) or < 3.0 ng/mL for all samples. Therefore, Cmax, Tmax, and AUC 0-12 were not summarized.||ng/mL|||Number
673692|NCT01660321|Primary|AUC (0-12) for Spinosyn A|Area under the plasma concentration versus time curve (AUC) of Spinosyn A in Natroba (spinosad) Topical Suspension, 0.9%.|Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.|Per Protocol. For all but 1 subject (Subject 02-202), all spinosyn A and spinosyn D concentrations were Below Quantification Level (BQL) or < 3.0 ng/mL for all samples. Therefore, Cmax, Tmax, and AUC 0-12 were not summarized.||ng*hr/mL|||Number
673693|NCT01660321|Primary|Tmax for Spinosyn A|The time after administration of Natroba (spinosad) Topical Suspension, 0.9% when the maximum plasma concentration is reached for Spinosyn A.|Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.|Per Protocol. For all but 1 subject (Subject 02-202), all spinosyn A and spinosyn D concentrations were Below Quantification Level (BQL) or < 3.0 ng/mL for all samples. Therefore, Cmax, Tmax, and AUC 0-12 were not summarized.||hours|||Number
673694|NCT01660321|Primary|Cmax for Spinosyn A|Peak Plasma Concentration of Spinosyn A in Natroba (spinosad) Topical Suspension, 0.9%|Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.|Per Protocol. For all but 1 subject (Subject 02-202), all spinosyn A and spinosyn D concentrations were Below Quantification Level (BQL) or < 3.0 ng/mL for all samples. Therefore, Cmax, Tmax, and AUC 0-12 were not summarized.||ng/mL|||Number
673695|NCT01660230|Secondary|Volume of Distribution (V) of 3K3A-APC by Compartmental Analysis|Multiple-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.|0, 20 minutes and 1 hour post for doses 1 and 5|All 'multiple-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.||mL||Standard Deviation|Mean
673696|NCT01660230|Secondary|Total Clearance (CL) of 3K3A-APC by Compartmental Analysis|Multiple-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.|0, 20 minutes and 1 hour post for doses 1 and 5|All 'multiple-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.||mL/h||Standard Deviation|Mean
674145|NCT01653743|Secondary|Mid-luteal Endometrial Thickness|Endometrial thickness was measured using TVUS.|Day 5 to 7 post hCG treatment|The Mod ITT population was defined as all subjects randomized to IMP (MSJ-0011 or u-hCG) and who completed the primary efficacy assessment.||millimeter||Standard Deviation|Mean
673697|NCT01660230|Secondary|Half-life (t1/2) of 3K3A-APC by Compartmental Analysis|Multiple-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.|0, 20 minutes and 1 hour post for doses 1 and 5|All 'multiple-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.||h||Standard Deviation|Mean
673698|NCT01660230|Secondary|Elimination Rate Constant (λz) for 3K3A-APC by Compartmental Analysis|Multiple-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.|0, 20 minutes and 1 hour post for doses 1 and 5|All 'multiple-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.||l/h||Standard Deviation|Mean
673699|NCT01660230|Secondary|Area Under the Plasma Concentration-time Curve From Time 0 to Infinity [AUC(0-inf)] for 3K3A-APC by Compartmental Analysis|Multiple-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.|0, 20 minutes and 1 hour post for doses 1 and 5|All 'multiple-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.||h x ng/mL||Standard Deviation|Mean
673700|NCT01660230|Secondary|Maximum Observed Plasma Concentration (Cmax) of 3K3A-APC by Compartmental Analysis|Multiple-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.|0, 20 minutes and 1 hour post for doses 1 and 5|All 'multiple-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.||ng/mL||Standard Deviation|Mean
673701|NCT01660230|Secondary|Volume of Distribution (V) of 3K3A-APC by Compartmental Analysis|Single-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.|0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post‐dose|All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.||mL||Standard Deviation|Mean
673702|NCT01660230|Secondary|Total Clearance (CL) of 3K3A-APC by Compartmental Analysis|Single-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.|0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post‐dose|All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.||mL/h||Standard Deviation|Mean
673703|NCT01660230|Secondary|Half-life (t1/2) of 3K3A-APC by Compartmental Analysis|Single-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.|0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post‐dose|All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.||h||Standard Deviation|Mean
673704|NCT01660230|Secondary|Elimination Rate Constant (λz) for 3K3A-APC by Compartmental Analysis|Single-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.|0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post‐dose|All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.||l/h||Standard Deviation|Mean
673705|NCT01660230|Secondary|Area Under the Plasma Concentration-time Curve From Time 0 to Infinity [AUC(0-inf)] for 3K3A-APC by Compartmental Analysis|Single-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.|0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post‐dose|All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.||h x ng/mL||Standard Deviation|Mean
673706|NCT01660230|Secondary|Maximum Observed Plasma Concentration (Cmax) of 3K3A-APC by Compartmental Analysis|Single-dose cohorts|0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post‐dose|All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.||ng/mL||Standard Deviation|Mean
673707|NCT01660230|Secondary|Volume of Distribution (Vz) of 3K3A-APC by Non-compartmental Analysis|Single-dose cohorts|0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post‐dose|All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.||mL||Standard Deviation|Mean
673860|NCT01657292|Secondary|Likert Scale Rating of Tolerance (Evaluated by Both the Investigators and Patients)|By direct comparison of the separate simultaneous treatments for the two wound halves, patients and investigators, respectively, are asked to provide their opinion on the tolerance of Oleogel-S10 Versus Standard of Care on a questionnaire with a 5-point graded visual analogue scale|2 to 3 weeks||||||
673709|NCT01660230|Secondary|Half-life (t1/2) of 3K3A-APC by Non-compartmental Analysis|Single-dose cohorts|0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post‐dose|All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.||h||Standard Deviation|Mean
673710|NCT01660230|Secondary|Elimination Rate Constant (λz) for 3K3A-APC by Non-compartmental Analysis|Single-dose cohorts|0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post‐dose|All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.||l/h||Standard Deviation|Mean
673711|NCT01660230|Secondary|Area Under the Plasma Concentration-time Curve From Time 0 to Infinity [AUC(0-inf)] for 3K3A-APC by Non-compartmental Analysis|Single-dose cohorts|0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post‐dose|All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.||h x ng/mL||Standard Deviation|Mean
673712|NCT01660230|Secondary|Area Under the Plasma Concentration-time Curve From Time 0 to the Final Time With a Concentration ≥ Limit of Quantitation [AUC(0-t)] for 3K3A-APC by Non-compartmental Analysis|Single-dose cohorts|0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post‐dose|All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.||h x ng/mL||Standard Deviation|Mean
673713|NCT01660230|Secondary|Time at Which Cmax is Observed (Tmax) for 3K3A-APC by Non-compartmental Analysis|Single-dose cohorts|0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post‐dose|All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.||hour (from start of infusion)||Full Range|Median
673714|NCT01660230|Secondary|Maximum Observed Plasma Concentration (Cmax) of 3K3A-APC by Non-compartmental Analysis|Single-dose cohorts|0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post‐dose|All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.||ng/mL||Standard Deviation|Mean
673715|NCT01660230|Primary|Adverse Events That Meet Dose-limiting Toxicity Criteria Specified in the Protocol.||Day 6 for multiple-dose cohorts|All 'multiple-dose' subjects who received at least one dose of study treatment.||participants|||Number
673716|NCT01660230|Primary|Adverse Events That Meet Dose-limiting Toxicity Criteria Specified in Protocol.||Day 4 for single-dose cohorts|All 'single-dose' subjects who received at least one dose of study treatment.||participants|||Number
673717|NCT01660191|Secondary|Changes HDL Particle Number and LDL Particle Number|Change in levels will be measured by difference in levels at 12 weeks.|Change from Baseline to 12 Weeks|||particle number||Standard Deviation|Mean
673718|NCT01660191|Secondary|Changes to Glucose Metabolism - Fructosamine|Change in levels will be measured by levels at 12 weeks minus levels at baseline. Changes measured based in fructosamine.|Change from Baseline to 12 weeks|||µmol||Standard Deviation|Mean
673719|NCT01660191|Secondary|Changes in HDL and LDL Size|Change in levels will be measured by difference in levels at 12 weeks|Change from Baseline to 12 Weeks|||nanometre (nm)||Standard Deviation|Mean
673720|NCT01660191|Secondary|Changes to Glucose Metabolism - HbA1c and Insulin|Change in levels will be measured by levels at 12 weeks minus levels at baseline. Changes measured based in HbA1c, and insulin.|Change from Baseline to 12 weeks|||percentage change from baseline measure||Standard Deviation|Mean
673721|NCT01660191|Secondary|Changes in Major Lipid Parameters - VLDL Size|Change in levels will be measured by difference in levels at 12 weeks. Measure based on VLDL size.|Change from Baseline to 12 Weeks|||nanometre (nm)||Standard Deviation|Mean
673722|NCT01660191|Primary|Changes in Plasma CoQ10 Levels|Change in levels will be measured by taking difference between Baseline and Week 12 measures.|Change from Baseline to 12 Weeks|||μg/g||Standard Deviation|Mean
673723|NCT01659021|Secondary|Complete Response Rate|Complete response rate was defined as the percentage of participants who achieve a complete response and maintain their response for at least 8 weeks (with a 1-week window).|Up to 37 months|ITT Analysis Set||percentage of participants|||Number
673724|NCT01659021|Secondary|Progression-Free Survival in Subgroup of Participants With Chromosome 17p Deletion and/or TP53 Mutation||Up to 37 months|Participants in the ITT Analysis Set with chromosome 17p deletion and/or TP53 mutation were analyzed.||months||95% Confidence Interval|Median
673725|NCT01659021|Secondary|Overall Survival|Overall survival was defined as the interval from randomization to death from any cause.|Up to 5 years|ITT Analysis Set||months||95% Confidence Interval|Median
673726|NCT01659021|Secondary|Lymph Node Response Rate|Lymph node response rate was defined as the proportion of participants who achieved a ≥ 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters (SPD) of index lymph nodes.|Up to 37 months|Participants in the ITT Analysis Set with available data were analyzed.||percentage of participants||95% Confidence Interval|Number
673727|NCT01659021|Secondary|Overall Response Rate|"Overall response rate was defined as the percentage of participants who achieved a best overall response of complete response or partial response.
Complete response was defined as no lymphadenopathy, hepatomegaly, splenomegaly; normal complete blood count; confirmed by bone marrow aspirate & biopsy.
Partial response was defined as >1 of the following criteria: a 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver size, spleen size; plus ≥ 1 of the following: ≥ 1500/μL absolute neutrophil count, > 100000/μL platelets, > 11.0 g/dL hemoglobin or 50% improvement for either of these parameters without transfusions or growth factors."|Up to 37 months|ITT Analysis Set||percentage of participants||95% Confidence Interval|Number
673728|NCT01659021|Primary|Progression-Free Survival|Progression-free survival was defined as the interval from randomization to the earlier of the first documentation of definitive disease progression or death from any cause. Definitive disease progression was CLL progression based on standard criteria (other than lymphocytosis alone) as defined by the 2008 update of the International Workshop on CLL guidelines, ie, appearance of any new lesion; increase by ≥ 50% in the sum of the products of the perpendicular diameters of measured lymph nodes (SPD); new or ≥ 50% enlargement of liver or spleen; transformation to a more aggressive histology (eg, Richter's or prolymphocytic transformation); reduction in the number of blood cells (cytopenia) attributable to CLL.|Up to 37 months|Intent-to-Treat (ITT) Analysis Set: participants who are randomized in the study with treatment group designated according to initial randomization.||months||95% Confidence Interval|Median
673729|NCT01658943|Other Pre-specified|Objective Response Rate|Confirmed response (CR) is two or more objective statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration. Partial response (PR) is two or more objective statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration. Unconfirmed CR is one objective status of CR documented before progression or symptomatic deterioration but not qualifying as CR or PR. Unconfirmed PR is one objective status of PR documented before progression or symptomatic deterioration but not qualifying as CR, PR or unconfirmed CR.|Up to 3 years|All eligible and analyzable patients with measurable disease.||participants|||Number
673730|NCT01658943|Other Pre-specified|Progression-free Survival|From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact.|Up to 3 years|Eligible and analyzable patients.||months||95% Confidence Interval|Median
673731|NCT01658943|Primary|Overall Survival|From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Up to 3 years|Eligible and analyzable patients.||months||95% Confidence Interval|Median
673732|NCT01658943|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Up to 3 years|Eligible patients who received any treatment and were assessed for adverse events are included in this summary.||Participants|||Number
673733|NCT01658904|Secondary|Evaluate the Effects of the Addition of Carfilzomib (CFZ) in the Early Post-Pre-autologous Hematopoietic Cell Transplantation (AHCT) Period on the Response Rate at Day 100 Post-AHCT||Day 100 post-AHCT|This outcome measure was not done because the study was closed prematurely because the investigator left the National Institutes of Health.|||||
673734|NCT01658904|Secondary|Evaluate the Immune Reconstitution Post-Pre-autologous Hematopoietic Cell Transplantation (AHCT) Following Carfilzomib (CFZ) Therapy||Post-AHCT following CFZ therapy|This outcome measure was not done because the study was closed prematurely because the investigator left the National Institutes of Health.|||||
673735|NCT01658904|Primary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|8 months and 15 days|Analysis of dose limiting toxicities (DLTs) was planned but not performed due to study termination; this Outcome Measure captures any events that occurred.||participants|||Number
673736|NCT01658904|Primary|Engraftment Failure Transplant Related Mortality|Engraftment failure is defined as the failure to achieve neutrophil engraftment by day 21; defined from day 0, day of autologous hematopoietic cell transplantation (AHCT), as the first of three consecutive days on which the patient's absolute neutrophil count is greater than 0.5x10(9)/l following the nadir. Transplant related mortality is defined as any subject who dies in the first 100 days post-AHCT of any non-relapse related cause.|up to day 100|||participants|||Number
673737|NCT01660022|Primary|Piperaquine t1/2|Piperaquine Elimination half-life (t1/2).|Up to 1008 hours post-dose (Day 43)|All randomised subjects who fulfilled the study protocol requirements in terms of study drug intake and PK samplings, with no major deviations that could affect the PK results.||hour||Geometric Coefficient of Variation|Geometric Mean
673738|NCT01660022|Primary|Piperaquine AUC(0-168)|Piperaquine area under the plasma concentration versus time curve to 168 hours post-dose|Up to 1008 hours post-dose (Day 43)|All randomised subjects who fulfilled the study protocol requirements in terms of study drug intake and PK samplings, with no major deviations that could affect the PK results.||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
673739|NCT01660022|Primary|OZ439 t1/2|OZ439 Elimination half-life|Up to 168 hours post-dose|All randomised subjects who fulfilled the study protocol requirements in terms of study drug intake and PK samplings, with no major deviations that could affect the PK results.||hour||Geometric Coefficient of Variation|Geometric Mean
673740|NCT01660022|Primary|OZ439 AUC(0-168)|Area under the plasma concentration versus time curve to 168 hours post-dose.|Up to 168 hours post-dose|All randomised subjects who fulfilled the study protocol requirements in terms of study drug intake and PK samplings, with no major deviations that could affect the PK results.||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
673741|NCT01660022|Primary|Piperaquine Cmax|Piperaquine Maximum concentration level|Up to 1008 hours post-dose (Day 43)|All randomised subjects who fulfilled the study protocol requirements in terms of study drug intake and PK samplings, with no major deviations that could affect the PK results.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
673742|NCT01660022|Primary|OZ439 Cmax|OZ439 Maximum concentration level|Up to 168 hours post-dose|All randomised subjects who fulfilled the study protocol requirements in terms of study drug intake and PK samplings, with no major deviations that could affect the PK results.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
673751|NCT01659996|Primary|Percentage of Study Participants Achieving Menactra Response for Meningococcal Serogroups A, C, Y, and W-135 Following the Second Menactra Vaccination|"Titers of antibodies to serogroups A, C, Y, and W-135 were measured by serum bactericidal assay using human complement (hSBA or SBA-HC).
Menactra vaccine response defined as subjects with an hSBA titer <1:8 at baseline achieving an hSBA titer ≥1:8, and subjects with an hSBA titer ≥1:8 at baseline achieving a ≥ 4-fold increase in hSBA titer."|Day 30 post second Menactra vaccination|Antibody titers to the meningococcal serogroups were assessed in the Per-protocol population of the participants in Menactra Vaccine Group and Menactra + Pentacel Vaccine Group.||Percentage of participants|||Number
673743|NCT01659996|Primary|Percentage of Participants With Antibody Responses to Diphtheria, Tetanus and Polyribosylribitol Phosphate Antigens Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine|"Anti-Tetanus antibodies were measured by enzyme-linked immunosorbent assay (ELISA), anti-polyribosylribitol phosphate (PRP) antibodies were measured using a Farr-type radioimmunoassay, and anti-diphtheria antibodies were measured by a toxin neutralization test.
The vaccine responses were defined as: Anti-PRP antibody concentrations ≥1.0 μg/mL; Anti-tetanus antibody concentrations ≥1.0 IU/mL and Anti-diphtheria antibody concentrations ≥1.0 IU/mL, respectively, 30 days after vaccination with Pentacel® in participants in Groups 2 and 3."|Day 30 post-vaccination 2|Antibody responses to Diphtheria, Tetanus, and Polyribosylribitol phosphate antigens were assessed in the Per-protocol population of the Menactra + Pentacel Vaccine Group and Pentacel Vaccine Group participants.||Percentage of Participants|||Number
673744|NCT01659996|Other Pre-specified|Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine|Solicited injection site reactions: Tenderness, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of appetite, and Irritability. Grade 3 reactions defined as: Tenderness - cries when injected limb is moved, or the movement of the injected limb is reduced; Erythema and Swelling - ≥ 50 mm; Fever > 39.5°C or > 103.1 °F; Vomiting - ≥ 6 episodes per 24 hours or requiring parenteral hydration; Abnormal crying > 3 hours; Drowsiness - Sleeping most of the time or difficult to wake up; Loss of appetite - Refuses ≥ 3 feeds/meals or refuses most feeds/meals; and Irritability - Inconsolable.|Day 0 to Day 7 after the 15 to 18 month vaccination|Solicited reactions were assessed in all subjects who received at least one dose of 15 to 18 month study vaccine, according to the vaccine actually received (Safety Analysis Population).||Percentage of participants|||Number
673745|NCT01659996|Primary|Percentage of Participants With Pertussis Vaccine Responses Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine|Pertussis antibodies, anti-Pertussis toxoid (PT), Filamentous hemagglutinin (FHA), and Pertactin (PRN) antibodies were measured by enzyme-linked immunosorbent assay (ELISA). Pertussis response was defined as: ≥4 × baseline concentration, if the anti-pertussis antibody concentration at baseline is <4 × lower limit of quantification (LLOQ), Or ≥2 × baseline concentration, if the anti-pertussis antibody concentration at baseline is ≥4 × LLOQ|Day 30 post-vaccination 2|Antibody responses to Pertussis vaccine antigens were assessed in the Per-protocol population of the Menactra + Pentacel Vaccine Group and Pentacel Vaccine Group participants.||Percentage of Participants|||Number
673746|NCT01659996|Primary|Geometric Mean Concentrations of Pertussis Vaccine Antibodies Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine|Pertussis antibodies, anti-Pertussis toxoid (PT), Filamentous hemagglutinin (FHA), Pertactin (PRN) antibodies were measured by enzyme-linked immunosorbent assay (ELISA).|Day 30 post-vaccination 2|Geometric Mean Concentrations (GMC) of Pertussis vaccine antibodies were assessed in the Per-protocol population of participants in Menactra + Pentacel Vaccine Group and Pentacel Vaccine Group.||Titers||95% Confidence Interval|Geometric Mean
673747|NCT01659996|Other Pre-specified|Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination at 9 Months of Age With Menactra Vaccine.|Solicited injection site reactions: Tenderness, Erythema, and Swelling. Solicited Systemic Reactions: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of appetite, and Irritability. Grade 3 solicited reactions defined as: Tenderness - cries when injected limb is moved, or the movement of the injected limb is reduced; Erythema and Swelling - ≥ 50 mm; Fever > 39.5°C or > 103.1 °F; Vomiting - ≥ 6 episodes per 24 hours or requiring parenteral hydration; Abnormal crying > 3 hours; Drowsiness - Sleeping most of the time or difficult to wake up; Loss of appetite - Refuses ≥ 3 feeds / meals or refuses most feeds/meals; and Irritability - Inconsolable.|Day 0 to Day 7 after 9-month vaccination|Solicited reactions were assessed in subjects who received at least one dose of study vaccine at 9 month of age, according to the vaccine actually received (Safety Analysis Population).||Percentage of participants|||Number
673748|NCT01659996|Other Pre-specified|Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine|Solicited injection-site reactions: Tenderness, Erythema, and Swelling. Solicited Systemic Reactions: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of appetite, and Irritability. Grade 3 solicited reactions defined as: Tenderness - cries when injected limb is moved, or the movement of the injected limb is reduced; Erythema and Swelling - ≥ 50 mm; Fever > 39.5°C or > 103.1 °F; Vomiting - ≥ 6 episodes per 24 hours or requiring parenteral hydration; Abnormal crying > 3 hours; Drowsiness - Sleeping most of the time or difficult to wake up; Loss of appetite - Refuses ≥ 3 feeds / meals or refuses most feeds / meals; and Irritability - Inconsolable.|Day 0 to Day 7 after any vaccination|Solicited reactions were assessed in all subjects who received at least one dose of study vaccine, according to the vaccine actually received (Safety Analysis Population).||Percentage of participants|||Number
673749|NCT01659996|Other Pre-specified|Geometric Mean Titers of Individual Antibodies to Filamentous Hemagglutinin, Pertactin, Diphtheria, Tetanus and Polio Antigens Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine|Filamentous hemagglutinin (FHA), Fimbriae types 2 and 3 (FIM), Pertactin (PRN) and anti-Tetanus antibodies were measured by enzyme-linked immunosorbent assay (ELISA); anti-Diphtheria antibodies were measured by a toxin neutralization test.|Day 0 (pre-vaccination) and Day 30 post-vaccination 2|Geometric mean titers of individual vaccine antibodies were assessed in the Per-protocol population of the Menactra + Pentacel Vaccine Group and the Pentacel Vaccine Group participants.||Titers||95% Confidence Interval|Geometric Mean
673750|NCT01659996|Other Pre-specified|Geometric Mean Titers of Individual Meningococcal Antibodies in Serum Bactericidal Assay With Human Complement (SBA-HC) Analysis Following Vaccination With Menactra Vaccine|Geometric mean titers (GMTs) of antibodies to serogroups A, C, Y, and W-135 were measured by serum bactericidal assay with human complement (SBA HC) before any vaccination and post-vaccination 2|Day 0 (pre-vaccination) and Day 30 post-vaccination 2|Geometric mean titers of individual antibodies were assessed in the Per-protocol population in the Menactra Vaccine Group and Menactra + Pentacel Vaccine Group participants.||Titers||95% Confidence Interval|Geometric Mean
673778|NCT01659268|Primary|Time to Conclusion of Simulation Scenario (OSCE)|This result present the total time for execution of simulation scenario (OSCE) by the students.|10 minutes|||seconds||Standard Deviation|Mean
673752|NCT01659853|Secondary|Onset of Action|Onset of action, defined as an improvement on both the clinician's and subject's erythema assessments at 30 minutes post baseline application|30 minutes after baseline treatment application on Day 15|A carryover effect was observed from Period 1 to Period 2. Therefore, as specified in the protocol, only the Period 1 results were analyzed. All 70 enrolled subjects were analyzed for efficacy.||percentage of subjects|||Number
673753|NCT01659853|Primary|Composite Success|Composite Success, defined as a 2-grade improvement at 6 hours on both the clinician's and subject's erythema assessments at the end of each treatment period|Hour 6 on Day 15|A carryover effect was observed from Period 1 to Period 2. Therefore, as specified in the protocol, only the Period 1 results were analyzed.||percentage of subjects|||Number
673754|NCT01659736|Primary|Remission Status|"Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) scores range from 0-56 with higher scores indicating more severe anxiety. Remission status was defined as a SIGH-A score < 8 and Clinical Global Impression Improvement score = 1 (very much improved) or 2 (much improved) at 3-month follow-up."|3-month follow-up|3-month follow-up completers||participants|||Number
673755|NCT01659736|Primary|Responder Status|Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) scores range from 0-56 with higher scores indicating more severe anxiety. Responder status was defined as a ≥ 50% improvement (i.e., reduction) in SIGH-A scores from pre-treatment to 3-month follow-up.|3-month follow-up|3-month follow-up completers||participants|||Number
673756|NCT01659736|Primary|Remission Status|"Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) scores range from 0-56 with higher scores indicating more severe anxiety. Remission status was defined as a SIGH-A score < 8 and Clinical Global Impression Improvement score = 1 (very much improved) or 2 (much improved) at post-treatment."|post-treatment, 6 weeks|Post-treatment completers||participants|||Number
673757|NCT01659736|Primary|Responder Status|Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) scores range from 0-56 with higher scores indicating more severe anxiety. Responder status was defined as a ≥ 50% improvement (i.e., reduction) in SIGH-A scores from pre-treatment to post-treatment.|Post-treatment, 6 weeks|Post-treatment completers||participants|||Number
673758|NCT01659736|Primary|Change in the Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) at Post-treatment and 3-month Follow-up.|Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) scores range from 0-56 with higher scores indicating more severe anxiety.|Pretreatment, Post-treatment (6 weeks after pretreatment), 3-month follow-up|Intent-to-treat sample (n = 25)||units on a scale||Standard Deviation|Mean
673759|NCT01659567|Secondary|OR for Impact of Cumulative Doses of Ribavirin on SVR|The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of cumulative doses of ribavirin on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).|At 24 weeks after EOT (up to 96 weeks), where EOT = up to 72 weeks|Analysis population included all treated participants.||odds ratio||95% Confidence Interval|Number
673760|NCT01659567|Secondary|OR for Impact of Cumulative Doses of Pegylated Interferon Alfa-2a on SVR|The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of cumulative doses of pegylated interferon alfa-2a on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).|At 24 weeks after EOT (up to 96 weeks), where EOT = up to 72 weeks|Analysis population included all treated participants.||odds ratio||95% Confidence Interval|Number
673761|NCT01659567|Secondary|OR for Impact of Duration of Treatment After Achieving cEVR on SVR|The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of duration of treatment after achieving cEVR (>11 weeks versus <=11 weeks) on SVR. cEVR was defined as HCV RNA <=25 IU/mL at Week 12, but not at Week 4 using CAP/CTM test. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).|Baseline up to 96 weeks (assessed at Baseline, Weeks 4, 12, EOT, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)|Analysis population included all treated participants.||odds ratio||95% Confidence Interval|Number
673762|NCT01659567|Secondary|OR for Impact of Duration of Treatment After Achieving RVR on SVR|The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of duration of treatment after achieving RVR (>18 weeks versus <=18 weeks) on SVR. RVR was defined as HCV RNA <=25 IU/mL at Week 4 using CAP/CTM test. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).|Baseline up to 96 weeks (assessed at Baseline, Week 4, EOT, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)|Analysis population included all treated participants.||odds ratio||95% Confidence Interval|Number
673763|NCT01659567|Secondary|OR for Impact of Overall Duration of Treatment on SVR|The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of overall duration of treatment on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).|Baseline up to 96 weeks (assessed at Baseline, EOT, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)|Analysis population included all treated participants.||odds ratio||95% Confidence Interval|Number
673764|NCT01659567|Secondary|OR for Impact of Baseline Viral Load Count on SVR|The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of baseline viral load count (>800000 IU/mL versus <=800000 IU/mL) on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).|Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)|Analysis population included all treated participants. Here, ‘Number of Participants Analyzed’ = participants evaluable for this outcome measure.||odds ratio||95% Confidence Interval|Number
673779|NCT01659268|Secondary|Number of Attempts to Insertion of LMA|Number of attempts for insertion of LMA and obtainment of effective ventilation.|10 minutes (total time of scenario)|||attempts||Standard Deviation|Mean
673780|NCT01659268|Secondary|Time for Acquisition of First Effective Ventilation, Adequate Tidal Volume and Stabilization of Patient.|"Time of achievement to first effective ventilation and tidal volume (adequate chest expansion).
Stabilization of mannequin parameters (spO2 e HR)."|10 minutes (600 sec)|||seconds||Standard Deviation|Mean
673765|NCT01659567|Secondary|OR for Impact of Baseline Alanine Transaminase (ALT) Level on SVR|The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of baseline ALT level (>40 international units per liter [IU/L] versus <=40 IU/L) on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).|Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)|Analysis population included all treated participants. Here, ‘Number of Participants Analyzed’ = participants evaluable for this outcome measure.||odds ratio||95% Confidence Interval|Number
673766|NCT01659567|Secondary|OR for Impact of Baseline Level of Fibrosis (kPa) on SVR|The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of baseline level of fibrosis on SVR. Level of fibrosis was measured in terms of kilopascals (kPa) using elastography. kPa score was categorized in 4 groups: 0 to 6.0; 6.1 to 9.9; 10.0 to 14.5; and 14.6 and above. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).|Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)|Analysis population included all treated participants. Here, ‘Number of Participants Analyzed’ = participants evaluable for this outcome measure.||odds ratio||95% Confidence Interval|Number
673767|NCT01659567|Secondary|OR for Impact of Body Weight on SVR|The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of body weight on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).|Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)|Analysis population included all treated participants.||odds ratio||95% Confidence Interval|Number
673768|NCT01659567|Secondary|OR for Impact of Gender on SVR|The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of gender (male versus female) on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).|Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)|Analysis population included all treated participants. Here, ‘Number of Participants Analyzed’ = participants evaluable for this outcome measure.||odds ratio||95% Confidence Interval|Number
673769|NCT01659567|Secondary|Odds Ratio (OR) for Impact of Age on SVR|The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of age (greater than [>] 42 years versus <=42 years) on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).|Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)|Analysis population included all treated participants. Here, ‘Number of Participants Analyzed’ = participants evaluable for this outcome measure.||odds ratio||95% Confidence Interval|Number
673770|NCT01659567|Primary|PPV of Complete Early Viral Response (cEVR) on SVR|cEVR was defined as HCV RNA <=25 IU/mL at Week 12, but not at Week 4 using CAP/CTM test. The percentage of participants with probability that the participant who develops cEVR would achieve SVR was termed as PPV of cEVR on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).|At 24 weeks after EOT (up to 96 weeks), where EOT = up to 72 weeks|Analysis population included all treated participants. Here, ‘Number of Participants Analyzed’ = participants evaluable for this outcome measure.||percentage of participants||95% Confidence Interval|Number
673771|NCT01659567|Primary|Positive Predictive Value (PPV) of Rapid Viral Response (RVR) on SVR|RVR was defined as HCV RNA less than or equal to (<=) 25 IU/mL at Week 4 using CAP/CTM test. The percentage of participants with probability that the participant who develops RVR would achieve SVR was termed as PPV of RVR on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).|At 24 weeks after EOT (up to 96 weeks), where EOT = up to 72 weeks|Analysis population included all treated participants. Here, ‘Number of Participants Analyzed’ = participants evaluable for this outcome measure.||percentage of participants||95% Confidence Interval|Number
673772|NCT01659567|Primary|Percentage of Participants Achieving Sustained Virological Response (SVR)|SVR was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) level undetectable (less than [<] 15 international units per milliliter [IU/mL]) 24 weeks after completion of the actual treatment period (measured using the COBAS AmpliPrep [CAP]/ COBAS TaqMan [CTM] test). Percentage of participants achieving SVR was reported.|At 24 weeks after end of treatment (EOT) (up to 96 weeks), where EOT = up to 72 weeks|Analysis population included all treated participants. Here, ‘Number of Participants Analyzed’ = participants evaluable for this outcome measure.||percentage of participants|||Number
673773|NCT01659554|Secondary|Kaplan-Meier Curves for Patient Overall Survival|Kaplan-Meier analysis will be done using PROC LIFETEST in Statistical Application Software (SAS).|Up to 5 years, survival|zero participants analyzed due to early termination of study|||||
673774|NCT01659554|Secondary|Time to Serum Ca-125 Nadir and/or CT Response (RECIST Criteria)|Efficacy of surgical resection with HIPEC combined with repeated intraperitoneal chemotherapy: The end point will be the objective response rate and progression-free survival as well as the overall survival, if feasible. We will analyze the time to serum Ca 125 nadir and/or CT response based on Recist criteria.|Up to 5 years (survival)|zero participants analyzed due to early termination of study|||||
673775|NCT01659554|Primary|Toxicity Rating Based on NCI Common Toxicity Criteria|Patients will be rated for toxicity prior to each cycle using the NCI Common Toxicity Criteria (NCICTC; see the CTCAE, Version 4.0).|Up to 5 years|zero participants analyzed due to early termination of study|||||
673776|NCT01659554|Primary|Adverse Event Rate and/or Laboratory Changes|The adverse event rate and laboratory changes will be used to investigate the safety of surgical debulking with heated intraperitoneal chemotherapy (HIPEC) combined with repeated intraperitoneal chemotherapy.|5 years|zero participants analyzed due to early termination of study|||||
673777|NCT01659320|Primary|Montgomery Asberg Depression Rating Scale (MADRS)|A published and widely-used scale for rating depression, the Montgomery Asberg Depression Rating Scale total scores range from 0-60. Higher scores indicate greater severity of depression. Total scores are reported with no subscales.|8 weeks|Among 13 subjects who completed the study.||units on a scale||Standard Deviation|Mean
673781|NCT01659268|Primary|Scores in Pre and Post-test, Number of Participants Successfully Completing the Overall Performance Simulated Scenario(OSCE).|"Score obtained in pre and post-test written, time to obtain the first effective ventilation (chest expansion through adequate ventilation on the mannequin), number of attempts to insert the LMA in the simulation scenario (OSCE).
Pre-test: 20 questions with score of 0.5 points each - minimum score=0 points and maximum score=10 points. Score 5-7 points was considered satisfactory; scores between 7-8 points was considered good performance; above 8 points excellent.
Post-test: 20 questions with score of 0.5 points each - minimum score=0 points and maximum score=10 points. Score 5-7 points was considered satisfactory; scores between 7-8 points was considered good performance; above 8 points excellent.
OSCE: instrument with total of 10 skills - each skill was subdivided in 4-5 activities (0.2-0.25 points each) - poor performance was score < 5.0; satisfactory performance 5.0-7.0; good 7.0-8.5 and excellent above 8.5 points."|Pretest: 40 minutes; Post-test: 40 minutes; OSCE: 10 minutes|The number of participants result of students that signed up in the workshop.||units on a scale||Standard Deviation|Mean
673782|NCT01659125|Primary|Responder Status|Participants who experienced a clinically significant change in Y-BOCS score defined as posttreatment YBOCS score that (a) has decreased by a reliable level (at least 1.96 times the standard deviation of that measure, taking into account the reliability of the measure itself; in this case, a decrease of 5 points or more), and (b) is within the nonclinical range of scores (in this case, a score of 13 or below).|Week 17 (post-treatment) and 6-month follow-up|Results are reported at each time-point for the intent-to-treat sample of participants who initiated treatment (n = 24).||participants|||Number
673783|NCT01659125|Primary|Change in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)|The Y-BOCS is a semi-structured interview that assesses severity of obsessions and compulsions. The total score is reported here and ranges from 0 to 40 with higher scores indicating more severe OCD symptoms.|Baseline (pretreatment), 17-weeks (posttreatment), and 6 month-follow-up|Results are reported at each time-point for the intent-to-treat sample of participants who initiated treatment (n = 24).||units on a scale||Standard Deviation|Mean
673784|NCT01658839|Primary|Half-life (t½)|Analyte plasma concentrations at each collection time point (predose, 10, 20, 40, 80 minutes postdose) were quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS). T½ was calculated for each participant with at least 3 quantifiable time points.|Day 7, Up to 80 minutes postdose|This analysis group includes all participants who received at least 2 doses of the study drug, satisfied protocol required criteria relevant to the assessments of PK parameters, had at least 1 postdose blood draw, and for whom adequate PK data were collected (without collection or analytical deviations that would affect the integrity of the data).||hours||Standard Deviation|Mean
673785|NCT01658839|Primary|Area Under the Analyte Plasma Concentration-time Curve Over the Dosing Interval (Inf)[AUC(0-∞)]|Analyte plasma concentrations at each collection time point (predose, 10, 20, 40, 80 minutes postdose) were quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS). AUC(0-∞) was calculated for each participant with at least 3 quantifiable time points.|Day 7, Up to 80 minutes postdose|This analysis group includes all participants who received at least 2 doses of the study drug, satisfied protocol required criteria relevant to the assessments of PK parameters, had at least 1 postdose blood draw, and for whom adequate PK data were collected (without collection or analytical deviations that would affect the integrity of the data).||ng*hr/mL||Standard Deviation|Mean
673786|NCT01658839|Primary|Area Under the Analyte Plasma Concentration-time Curve to the Last Quantifiable Sampling Time Point [AUC(0-tlast)]|Analyte plasma concentrations at each collection time point (predose, 10, 20, 40, 80 minutes postdose) were quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS). AUC(0-tlast) was calculated for each participant with at least 2 quantifiable time points.|Day 7, Up to 80 minutes postdose|This analysis group includes all participants who received at least 2 doses of the study drug, satisfied protocol required criteria relevant to the assessments of PK parameters, had at least 1 postdose blood draw, and for whom adequate PK data were collected (without collection or analytical deviations that would affect the integrity of the data).||ng*hr/mL||Standard Deviation|Mean
673787|NCT01658839|Primary|Time to Last Measurable Concentration (Tlast)|Analyte plasma concentrations at each collection time point (predose, 10, 20, 40, 80 minutes postdose) were quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS). Tlast was calculated for each participant with at least 1 quantifiable time point.|Day 7, Up to 80 minutes postdose|This analysis group includes all participants who received at least 2 doses of the study drug, satisfied protocol required criteria relevant to the assessments of PK parameters, had at least 1 postdose blood draw, and for whom adequate PK data were collected (without collection or analytical deviations that would affect the integrity of the data).||hours||Standard Deviation|Mean
673788|NCT01658839|Primary|Time to Reach Cmax (Tmax)|Analyte plasma concentrations at each collection time point (predose, 10, 20, 40, 80 minutes postdose) were quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS). Tmax was calculated for each participant with at least 1 quantifiable time point.|Day 7, Up to 80 minutes postdose|This analysis group includes all participants who received at least 2 doses of the study drug, satisfied protocol required criteria relevant to the assessments of PK parameters, had at least 1 postdose blood draw, and for whom adequate PK data were collected (without collection or analytical deviations that would affect the integrity of the data).||hours||Standard Deviation|Mean
673789|NCT01658839|Primary|Maximum Observed Travoprost Free Acid Plasma Concentration (Cmax)|Travoprost free acid plasma concentrations at each collection time point (predose, 10, 20, 40, 80 minutes postdose) were quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS). Cmax was calculated for each participant with at least 1 quantifiable time point.|Day 7, Up to 80 minutes postdose|This analysis group includes all participants who received at least 2 doses of the study drug, satisfied protocol required criteria relevant to the assessments of PK parameters, had at least 1 postdose blood draw, and for whom adequate PK data were collected (without collection or analytical deviations that would affect the integrity of the data).||ng/mL||Standard Deviation|Mean
673795|NCT01658735|Secondary|Change From Baseline in VAS Pain Score at 12 Weeks|"Measure of the change in visual analogue scale (VAS) after twelve weeks of treatment compared with baseline VAS measure.
The VAS is a commonly used continuous scale measure for low back pain. For pain intensity, the scale is anchored by “no pain” (score of 0) and “pain as bad as it could be” or “worst imaginable pain” (score of 10). Higher scores represent higher reported pain."|Week 12|||units on a scale||95% Confidence Interval|Mean
673796|NCT01658735|Secondary|Change From Baseline in VAS Pain Score at 8 Weeks|"Measure of the change in visual analogue scale (VAS) after eight weeks of treatment compared with baseline VAS measure.
The VAS is a commonly used continuous scale measure for low back pain. For pain intensity, the scale is anchored by “no pain” (score of 0) and “pain as bad as it could be” or “worst imaginable pain” (score of 10). Higher scores represent higher reported pain."|Week 8|||units on a scale||95% Confidence Interval|Mean
673797|NCT01658735|Secondary|Change From Baseline in VAS Pain Score at 4 Weeks|"Measure of the change in visual analogue scale (VAS) after four weeks of treatment compared with baseline VAS measure.
The VAS is a commonly used continuous scale measure for low back pain. For pain intensity, the scale is anchored by “no pain” (score of 0) and “pain as bad as it could be” or “worst imaginable pain” (score of 10). Higher scores represent higher reported pain."|Week 4|||units on a scale||95% Confidence Interval|Mean
673798|NCT01658735|Secondary|Change From Baseline in VAS Pain Score at 1 Week|"Measure of the change in visual analogue scale (VAS) after one week of treatment compared with baseline VAS measure.
The VAS is a commonly used continuous scale measure for low back pain. For pain intensity, the scale is anchored by “no pain” (score of 0) and “pain as bad as it could be” or “worst imaginable pain” (score of 10). Higher scores represent higher reported pain."|Week 1|||units on a scale||95% Confidence Interval|Mean
673799|NCT01658735|Primary|Change From Baseline in Oswestry Disability Index at 12 Weeks|"Measure of the change in Oswestry Disability Index (ODI) after twelve weeks of treatment compared with baseline measure.
The ODI is a commonly used outcome-measure questionnaire for low back pain. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0–5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage, with a possible range of 0 to 100. Higher scores represent higher reported disability."|Week 12|||units on a scale||95% Confidence Interval|Mean
673800|NCT01658735|Primary|Change From Baseline in Oswestry Disability Index at 8 Weeks|"Measure of the change in Oswestry Disability Index (ODI) after eight weeks of treatment compared with baseline measure.
The ODI is a commonly used outcome-measure questionnaire for low back pain. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0–5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage, with a possible range of 0 to 100. Higher scores represent higher reported disability."|Week 8|||units on a scale||95% Confidence Interval|Mean
673801|NCT01658735|Primary|Change From Baseline in Oswestry Disability Index at 4 Weeks|"Measure of the change in Oswestry Disability Index (ODI) after four weeks of treatment compared with baseline measure.
The ODI is a commonly used outcome-measure questionnaire for low back pain. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0–5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage, with a possible range of 0 to 100. Higher scores represent higher reported disability."|Week 4|||units on a scale||95% Confidence Interval|Mean
673802|NCT01658735|Primary|Change From Baseline in Oswestry Disability Index at 1 Week|"Measure of the change in Oswestry Disability Index (ODI) after one week of treatment compared with baseline measure.
The ODI is a commonly used outcome-measure questionnaire for low back pain. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0–5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage, with a possible range of 0 to 100. Higher scores represent higher reported disability."|1 week|||units on a scale||95% Confidence Interval|Mean
673803|NCT01658657|Primary|Blood Pressure Control, as Defined as Office BP Measurement of <140 mmHg Systolic and <90 mmHg Diastolic|At each study visit (approximately every 30 days), participants' BP will be checked. If BP is controlled (<140mmHG systolic and <90mmHG diastolic), then current medication will continue. If BP is uncontrolled, medication will be revised every 30 days (up to 120) until BP control is achieved.|4 months|6 participants withdrawn before study completion||participants|||Number
673861|NCT01657292|Secondary|Cosmetic Outcome After 3 and 12 Months After Burn Accident, in Relation to Texture, Redness, Growth of Hair and Pigmentation, Based on Blinded Photo Evaluation||3 and 12 months||||||
674256|NCT01652716|Secondary|Change in Body Weight (kg) From Baseline to Week 28|Change in body weight (kg) from baseline to Week 28/Study Termination.|Baseline to Week 28|Modified Intent-to-Treat: Subjects who were randomized and received at least one dose of study drug.||kg||Standard Error|Least Squares Mean
673804|NCT01658579|Secondary|Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline Up to Week 16|Hypoglycemia events were Severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); Documented symptomatic hypoglycemia (typical symptoms of hypoglycemia with plasma glucose level of <=3.9 mmol/L [70 mg/dL]); Asymptomatic hypoglycemia (no typical symptoms of hypoglycemia but plasma glucose level <=3.9 mmol/L); Probable symptomatic hypoglycemia (an event during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination, but was presumably caused by a plasma glucose level <=3.9 mmol/L, symptoms treated with oral carbohydrate without a test of plasma glucose); Relative hypoglycemia (an event during which the person with diabetes reported any of the typical symptoms of hypoglycemia, and interpreted the symptoms as indicative of hypoglycemia, but plasma glucose level >3.9 mmol/L); Severe and/or confirmed a hypoglycemia (plasma glucose <=3.9 mmol/L).|Up to Week 16|Safety population: all randomized participants who were exposed to at least one dose, regardless of amount of treatment administered. In the event of participants having received treatments different from those assigned according to the randomization schedule, safety analyses were conducted according to treatment received.||percentage of participants|||Number
673805|NCT01658579|Secondary|Change in Basal Insulin Daily Dose From Baseline to Week 8 and 16||Baseline, Week 8, 16|Modified Intent-to-Treat population. Here n = participants with basal insulin dose assessment at specified time-point. Missing data imputed using LOCF.||U/kg||Standard Deviation|Mean
673806|NCT01658579|Secondary|Change in Average 7-Point Self-Monitored Plasma Glucose (SMPG) Profile From Baseline to Week 8 and 16|Change in average of 7-point SMPG. 7-point SMPG was assessed starting with a measurement at before breakfast and 2 hours after breakfast; before and 2 hours after lunch; before and 2 hours after dinner; at bedtime.|Baseline, Week 8, 16|Modified Intent-to-Treat population. Number of participants analyzed = participants with baseline, Week 8 and/or 16 7-point SMPG assessment, n = participants with 7-point SMPG assessment at specified time. Missing data imputed using LOCF.||mmol/L||Standard Deviation|Mean
673807|NCT01658579|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 8 and 16||Baseline, Week 8, 16|Modified Intent-to-Treat population. Number of participants analyzed = participants with baseline, Week 8 and/or 16 FPG assessment, n = participants with FPG assessment at specified time. Missing data imputed using LOCF.||mmol/L||Standard Deviation|Mean
673808|NCT01658579|Secondary|Change in HbA1c From Baseline to Week 8 and 16||Baseline, Week 8, 16|Modified Intent-to-Treat population: randomized participants who received at least 1 dose; had baseline, at least 1 post-baseline efficacy assessment; irrespective of compliance. Number of participants analyzed = participants with baseline, Week 8 and/or 16 HbA1c assessment, n = participants with HbA1c assessment at specified time. LOCF applied.||percentage of hemoglobin||Standard Deviation|Mean
673809|NCT01658579|Secondary|Percentage of Time in Target Plasma Glucose Range (4.4-7.8 mmol/L [80–140 mg/dL]) in the Last Four Hours of Each Dosing Interval at Weeks 7 and 8 in Period A and Weeks 15 and 16 in Period B|Percentage of time with glucose within glycemic range (4.4-7.8 mmol/L) was assessed by the total time within glycemic range divided by the length of the assessment interval.|Weeks 7-8 in Period A and Weeks 15-16 in Period B|CGM population. Number of participants analyzed = participants with baseline, Weeks 7, 8 (Period A), and/or Weeks 15, 16 (Period B) CGM assessment, and n = participants with assessment at specified time-point.||percentage of time||Standard Deviation|Mean
673810|NCT01658579|Secondary|Evaluation of Diurnal Glucose Exposure, Variability, and Stability|The diurnal glucose exposure is measured as the average diurnal glucose concentration, diurnal glucose variability is measured by interquartile range (IQR), that is, average distance between the 25th and the 75th point-wise percentiles and diurnal glucose stability is assessed in terms of the mean absolute rate of change (mmol/l), that is, the area under the absolute rate of change of the median curve (based on the median point values between two adjacent hourly basket intervals), divided by the length of the assessment interval.|Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B)|CGM population. Number of participants analyzed = participants with baseline, Weeks 7, 8 (Period A), and/or Weeks 15, 16 (Period B) CGM assessment. Missing data imputed using LOCF.||mmol/L||Standard Error|Least Squares Mean
673811|NCT01658579|Secondary|Percentage of Time Below The Lower Limit of Glycemic Range (<4.4 mmol/L [80 mg/dL])|Percentage of time with glucose below the lower limit of glycemic range (<4.4 mmol/L) was assessed by the total time below the lower limit of glycemic range divided by the length of the assessment interval.|Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B)|CGM population. Number of participants analyzed = participants with baseline, Weeks 7, 8 (Period A), and/or Weeks 15, 16 (Period B) CGM assessment. Missing data imputed using LOCF.||percentage of time||Standard Error|Least Squares Mean
673812|NCT01658579|Secondary|Percentage of Time Above the Upper Limit of Glycemic Range (Greater Than [>] 7.8 mmol/L [(140 mg/dL])|Percentage of time with glucose above the upper limit of glycemic range (>7.8 mmol/L) was assessed by the total time above the upper limit of glycemic range divided by the length of the assessment interval.|Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B)|CGM population. Number of participants analyzed = participants with baseline, Weeks 7, 8 (Period A), and/or Weeks 15, 16 (Period B) CGM assessment. Missing data imputed using last observation carried forward (LOCF).||percentage of time||Standard Error|Least Squares Mean
673813|NCT01658579|Primary|Percentage of Time in Target Plasma Glucose Range (4.4-7.8 mmol/L [80-140 mg/dL])|Percentage of time with glucose within glycemic range (4.4-7.8 mmol/L) was assessed by the total time within glycemic range divided by the length of the assessment interval.|Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B)|Continuous glucose monitoring (CGM) population: All participants who received at least 1 dose, had evaluable post-baseline CGM data, irrespective of compliance. Number of participants analyzed = participants with baseline, Weeks 7-8 (Period A) and/or Weeks 15-16 (Period B) CGM assessment. Missing data imputed using last observation carried forward.||percentage of time||Standard Error|Least Squares Mean
673814|NCT01658514|Primary|Correlation of Placebo-adjusted Change From Pre-dose Value in Lactate Versus Metformin Concentration|To determine the exposure-response relationship of metformin and plasma lactate concentrations|from the time of dosing (0 h) to 24 hours postdose|PD Evaluable Population||R²|||Number
673815|NCT01658514|Primary|Cmax of Plasma Metformin|Cmax = Maximum concentration from the time of dosing (0 h) to the time of the last quantifiable metformin concentration following dose administration|from the time of dosing (0 h) to 72 hours postdose|PK Evaluable Population||ng/mL||Standard Error|Least Squares Mean
673817|NCT01658436|Secondary|Stage 1 - Disease Control Rate|Disease control rate was defined as the proportion of patients with a best overall response of Complete Response, Partial response, or Stable disease, based on the investigator's assessment per RECIST version 1.1. Based on futility analysis conducted at the end of stage 1, stage 2 was not initiated.|Baseline, every 8 weeks up to 31 months|The Full Analysis Set (FAS) comprised of all patients who received at least one dose of study treatment (Stage 1). This set was known as ‘Analysis Set Stage 1’ (AS1).||Percentage of participants||95% Confidence Interval|Number
673818|NCT01658436|Secondary|Stage 1- Overall Response Rate (ORR)|Overall Response rate was defined as the proportion of patients with a best overall response of complete response or partial response, based on investigator's assessment as per RECIST criteria version 1.1. Based on futility analysis conducted at the end of stage 1, stage 2 was not initiated.|Baseline, every 8 weeks up to 31 months|The Full Analysis Set (FAS) comprised of all patients who received at least one dose of study treatment (Stage 1). This set was known as ‘Analysis Set Stage 1’ (AS1).||Percentage of participants|||Number
673819|NCT01658436|Primary|Stage 1 - Progression Free Survival (PFS) Rate Analysis at 16 Weeks as Per Local Radiology Review|PFS rate at 16 weeks was defined as a binary variable. Patients were considered as ‘progression free’ after 16 weeks if they had an overall lesion response of complete response (CR) partial response (‘PR) or stable disease (SD)’ and “progressed” if they had an overall lesion response of ‘Progressive disease (PD) at the scan which occurred on day 105 after start of treatment, or later. Patients whose 16 weeks tumor assessment was unknown, missing or outside the window was not considered as ‘progression free’ and was considered a “failure” and counted only in the denominator for the estimation of the 16 week progression free rate.|16 weeks after the first BEZ235 administration.|The Full Analysis Set (FAS) comprised of all patients who received at least one dose of study treatment (Stage 1). This set was known as ‘Analysis Set Stage 1’ (AS1).||Percentage of participants||95% Confidence Interval|Number
673820|NCT01658072|Primary|Time Until Patient is Ready for Discharge|"readiness for discharge to home or to a rehabilitation facility (compared to the HSS standard regimen of epidural analgesia) after total hip arthroplasty."|Length of Hospital Stay, an expected average of 3 days|||days||Standard Deviation|Mean
673821|NCT01658020|Secondary|Change in CAT Scores|"The outcome measurement is Change in CAT scores for clinical populations at Test of cure visit.
CAT score means that COPD Assessment Test was used as a tool to assess the effects of COPD on physical, mental status and daily life.
CAT is consisted of 8 items in total and each question item was scored from 0 point to 5 point.
The scores of each question item were summed into the total score, which had values between 0 and 40."|10 days|Per protocol population||scores on a scale||Standard Deviation|Mean
673822|NCT01658020|Secondary|Change in EXACT-PRO Score|"The outcome measurement is Change in EXACT-PRO score for clinical populations at Test of cure visit.
EXACT-PRO means that the questionnaires for Exacerbation of Chronic Pulmonary Disease Tool-Patient Reported Outcome of United BioSource Corporation(UBC) of USA that had been standardized, equipped with reliability and feasibility applicable to various COPD patients groups were used in order to quantitate frequency, severity and duration of acute exacerbation as a tool to measure acute exacerbation of COPD.
EXACT-PRO is consisted of 14 questionnaire items were classified into 3 domains, Respiratory Distress Domain, Cough/Sputum Domain, and Chest Symptoms Domain. The Scores of each domain were to be summed into the domain raw summed score or converted into EXACT domain score according to the conversion table. The total score had value in the range from 0 to 100 and higher the value was, severer the respiratory symptoms were in evaluation."|10 days|Per protocol population||scores on a scale||Standard Deviation|Mean
673823|NCT01658020|Secondary|Microbiological Response Rate|"Microbiological response rate in the microbiological per protocol(PP) population.
Microbiological rate were discriminated for the pathogens isolated from the respiratory secretion samples of subjects."|10days|||Percentage of participants||95% Confidence Interval|Number
673824|NCT01658020|Secondary|Clinical Cure Rate in the Microbiological Per Protocol(PP) Population|"Clinical response corresponding clinical cure in the microbiological per-protocol population.
Microbiological responses were discriminated for the pathogens isolated from the respiratory secretion samples of subjects."|10days|||Percentage of participants||95% Confidence Interval|Number
673825|NCT01658020|Secondary|Clinical Response in the Clinical Population|Clinical response corresponding clinical cure at End of Study visit. Based on the clinical outcomes, the results of assessment were classified into Clinical Cure, Clinical Failure, Relapse and Indeterminate.|36days|Per protocol population||percentage of participants||95% Confidence Interval|Number
673826|NCT01658020|Primary|Clinical Response in the Clinical Populations|Clinical response corresponding clinical cure at Test of Cure visit. Based on the clinical outcomes, the results of assessment were classified into Clinical Cure, Clinical Failure, Relapse and Indeterminate.|10days|Per protocol population||percentage of participants||95% Confidence Interval|Number
673827|NCT01657903|Other Pre-specified|SMH Recovery of Enamel Specimens Post 2 Hours of Treatment Exposure|SMH test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMH recovery was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: [(E1- R)/ (E1-B)]*100. A higher percentage values indicate a better outcome.|Baseline, 2 hours post treatment in each treatment period|PP population: All randomized subjects who had at least one assessment of efficacy and considered unaffected by major protocol deviations, were included in analysis.||Percentage SMH||Standard Error|Least Squares Mean
673828|NCT01657903|Other Pre-specified|RER of Enamel Specimens Post 2 Hours of Treatment Exposure|Enamel specimens were exposed to dietary erosive challenge and set of five indentations within each specimen was measured. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine RER which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent RER was calculated by formula: [(E1-E2)/ (E1-B)]*100. Smaller the negative RER, better is treatment regimen in imparting resistance to enamel.|Baseline, 2 hours post treatment in each treatment period|PP population: All randomized subjects who had at least one assessment of efficacy and considered unaffected by major protocol deviations, were included in analysis. Due to drop outs, there was difference in number of participants analyzed.||% RER||Standard Error|Least Squares Mean
673829|NCT01657903|Primary|Surface Microhardness (SMH) Recovery of Enamel Specimens Post 4 Hours of Treatment Exposure|SMH test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMH recovery was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: [(E1- R)/ (E1-B)]*100. A higher percentage values indicate a better outcome.|Baseline, 4 hours post treatment in each treatment period|PP population: All randomized subjects who had at least one assessment of efficacy and considered unaffected by major protocol deviations, were included in analysis. Due to drop outs, there was difference in number of participants analyzed.||Percentage SMH||Standard Error|Least Squares Mean
673830|NCT01657903|Primary|Relative Erosion Resistance (RER) of Enamel Specimens Post 4 Hours of Treatment Exposure|Enamel specimens were exposed to dietary erosive challenge and set of five indentations within each specimen was measured. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine RER which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent RER was calculated by formula: [(E1-E2)/ (E1-B)]*100. Smaller the negative RER, better is treatment regimen in imparting resistance to enamel.|Baseline, 4 hours post treatment in each treatment period|Per protocol (PP) population: All randomized subjects who had at least one assessment of efficacy and considered unaffected by major protocol deviations, were included in analysis. Due to drop outs, there was difference in number of participants analyzed.||Percentage RER||Standard Error|Least Squares Mean
673831|NCT01657877|Primary|Percentage (%) Change in Surface Microhardness (SMH) Following 21 Days of Twice Daily Treatment With the 1500 Ppm Fluoride + 5% CSP Dentifrice and With the 1500 Ppm Fluoride Dentifrice.|Percent SMH recovery (SMHR) was calculated from hardness values of enamel specimens at baseline (B), after in-situ hardening (R) and after first demineralization challenge (D1) using formula: [(D1-R)/ (D1-B)]*100. A greater percentage change in SMHR represents a better remineralisation and hence a better outcome.|Baseline to 21 days|Per protocol (PP) population: The per protocol (PP) population was defined as those subjects in the intention to treat population who did not have protocol violations leading to exclusion of all efficacy data from analyses. Missing data was not imputed.||Percentage SMHR||Standard Error|Mean
673832|NCT01657877|Secondary|Enamel Fluoride Uptake (EFU)|Change to EFU was determine using a microdrill enamel biopsy of the in situ enamel specimens.|Baseline to 21 days|PP population: all randomized participants in the ITT population who had no protocol violations leading to exclusion of all efficacy data from analyses. Missing data was not imputed. Due to drop out there were differences in the number of participants analyzed per treatment group.||ppm EFU||Standard Error|Mean
673833|NCT01657877|Secondary|Percentage (%) Change in SMH Following 21 Days of Twice Daily Treatment With 500 Ppm Fluoride as SMFP and 0 % CSP Dentifrice, 0 Ppm Fluoride and 0% CSP, and 0 Ppm Fluoride and 5 % CSP.|Percent SMH recovery (SMHR) was calculated from hardness values of enamel specimens at baseline (B), after in-situ hardening (R) and after first demineralization challenge (D1) using formula: [(D1-R)/ (D1-B)]*100. A greater percentage change in SMHR represents a better remineralisation and hence a better outcome.|Baseline to 21 days|PP population:all randomized participants in the ITT population who had no protocol violations leading to exclusion of all efficacy data from analyses.||Percentage SMHR||Standard Error|Mean
673834|NCT01657461|Other Pre-specified|Incidence of sICH at 27±6 Hours Post Randomization||27±6 hours post randomization|One subject in the IV t-PA arm withdrew and requested all data be removed.||Participants|||Count of Participants
673835|NCT01657461|Other Pre-specified|Incidence of All Serious Adverse Events (SAEs)||Through 90 days|One subject in the IV t-PA arm withdrew and requested all data be removed.||Participants|||Count of Participants
673836|NCT01657461|Secondary|Correlation of RAPID-assessed Core Infarct Volume With 27±6 Hours Post Randomization Stroke Infarction in Subjects Who Achieved TICI 2b-3 Reperfusion Without Intracranial Hemorrhage||27±6 hours post randomization|Final assessment not available for all subjects.||Correlation|||Number
673837|NCT01657461|Secondary|Arterial Revascularization Measured by TICI 2b or 3 Following Device Use||Post procedure|Final assessment not available for all subjects.||Participants|||Count of Participants
673838|NCT01657461|Secondary|Reperfusion Measured by Reperfusion Ratio on CT or MRI Scan 27±6 Hours Post Randomization||27±6 hours post randomization|Final assessment not available for all subjects.||Reperfusion ratio||Standard Deviation|Mean
673839|NCT01657461|Secondary|Volume of Cerebral Infarction as Measured by a CT or MRI Scan at 27±6 Hours Post Randomization||27±6 hours post randomization|Final assessment not available for all subjects.||cc||Standard Deviation|Mean
673840|NCT01657461|Secondary|Change in NIH Stroke Scale Score at 27 ± 6 Hrs Post Randomization|The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. NIHSS scores range from 0 – 42. A score of 0 indicates no stroke symptoms. Higher scores indicate incremental levels of neurological impairment.|Baseline to 27±6 hours post randomization|Final assessment not available for all subjects.||units on a scale||Standard Deviation|Mean
673841|NCT01657461|Secondary|Functional Independence as Defined by Modified Rankin Scale (mRS) Score ≤2 at 90 Days||90 days|Final assessment unavailable for 5 subjects that withdrew consent or investigator withdrew consent in IV t-PA arm.||Participants|||Count of Participants
673842|NCT01657461|Secondary|Death Due to Any Cause at 90 Days||90 days|One subject in the IV t-PA arm withdrew and requested all data be removed.||Participants|||Count of Participants
673862|NCT01657292|Secondary|Likert Scale Rating of Efficacy (Evaluated by Both the Investigators and Patients)|By direct comparison of the separate simultaneous treatments for the two wound halves, patients and investigators, respectively, are asked to grade the efficacy of Oleogel-S10 Versus Standard of Care on a questionnaire with a 5-point graded visual analogue scale|2 to 3 weeks||||||
673863|NCT01657292|Secondary|Percentage of Wound Epithelialization at Different Time Points as Assessed by the Investigator||2 to 3 weeks||||||
673864|NCT01657292|Secondary|Percentage of Patients With Wound Closure at Different Time Points||2 to 3 weeks||||||
673843|NCT01657461|Primary|90-day Global Disability Assessed Via the Blinded Evaluation of Modified Rankin Score (mRS).|"mRS is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke. 0 No symptoms at all
No significant disability despite symptoms; able to carry out all usual duties and activities
Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance
Moderate disability; requiring some help, but able to walk without assistance
Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance
Severe disability; bedridden, incontinent and requiring constant nursing care and attention
Dead"|90 days|Final assessment unavailable for 5 subjects that withdrew consent or investigator withdrew consent in IV t-PA arm.||Participants|||Count of Participants
673844|NCT01657370|Other Pre-specified|Plasma MK-1602 Concentrations at Visit 2 (Day 4)||Up to 3.5 hours post dose 3|As per protocol, only listings of individual plasma concentrations for MK-1602 over time were produced. No formal non-compartmental PK analysis was done for this outcome measure.|||||
673845|NCT01657370|Other Pre-specified|Dry Blood Spot MK-1602 Concentration at 3.5 Hours Post-Dose at Visit 2 (Day 4)||3.5 hours post dose 3|As per protocol, only listings of individual DBS concentrations for MK-1602 over time were produced. No formal non-compartmental PK analysis was done for this outcome measure.|||||
673846|NCT01657370|Other Pre-specified|Dry Blood Spot (DBS) MK-1602 Concentrations on Migraine Treatment Day||Up to 24 hours post dose 1|As per protocol, only listings of individual DBS for MK-1602 over time were produced. No formal non-compartmental Pharmacokinetic (PK) analysis was done for this outcome measure.|||||
673847|NCT01657370|Secondary|Percentage of Participants With TMF From 2-24 Hours Post-Dose on Migraine Treatment Day|TMF from 2-24 hours post-dose was defined as SPF with no photophobia, phonophobia, nausea, or vomiting during the 2-24 hour period after dosing with study medication.|2-24 hours post dose 1|Full Analysis Set included all participants who received study treatment, had a Baseline headache severity measurement, and at least one post-dose efficacy measurement prior to, or including, the 2-hour time point.||percentage of participants||95% Confidence Interval|Number
673848|NCT01657370|Secondary|Percentage of Participants With Total Migraine Freedom (TMF) at 2 Hours Post-Dose on Migraine Treatment Day|TMF at 2 hours post-dose was defined as PF with no photophobia, phonophobia, nausea, or vomiting at 2 hours post-dose.|2 hours post dose 1|Full Analysis Set included all participants who received study treatment, had a Baseline headache severity measurement, and at least one post-dose efficacy measurement prior to, or including, the 2-hour time point.||percentage of participants||95% Confidence Interval|Number
673849|NCT01657370|Secondary|Percentage of Participants With Sustained Pain Relief (SPR) From 2-24 Hours Post-Dose on Migraine Treatment Day|SPR was defined as PR at 2 hours post-dose, with no administration of any rescue medication and with no occurrence of a moderate/severe headache during the 2-24 hour period after dosing with study medication.|2-24 hours post dose 1|Full Analysis Set included all participants who received study treatment, had a Baseline headache severity measurement, and at least one post-dose efficacy measurement prior to, or including, the 2-hour time point.||percentage of participants||95% Confidence Interval|Number
673850|NCT01657370|Secondary|Percentage of Participants With Sustained Pain Freedom (SPF) From 2-24 Hours Post-Dose on Migraine Treatment Day|SPF was defined as PF at 2 hours post-dose, with no administration of any rescue medication and with no occurrence of a mild/moderate/severe headache during the 2-24 hour period after dosing with study medication.|2-24 hours post dose 1|Full Analysis Set included all participants who received study treatment, had a Baseline headache severity measurement, and at least one post-dose efficacy measurement prior to, or including, the 2-hour time point.||percentage of participants||95% Confidence Interval|Number
673851|NCT01657370|Secondary|Percentage of Participants Reporting Absence of Nausea at 2 Hours Post-Dose on Migraine Treatment Day||2 hours post dose 1|Full Analysis Set included all participants who received study treatment, had a Baseline headache severity measurement, and at least one post-dose efficacy measurement prior to, or including, the 2-hour time point.||percentage of participants||95% Confidence Interval|Number
673852|NCT01657370|Secondary|Percentage of Participants Reporting Absence of Photophobia at 2 Hours Post-Dose on Migraine Treatment Day|Photophobia is sensitivity to light.|2 hours post dose 1|Full Analysis Set included all participants who received study treatment, had a Baseline headache severity measurement, and at least one post-dose efficacy measurement prior to, or including, the 2-hour time point.||percentage of participants||95% Confidence Interval|Number
673853|NCT01657370|Secondary|Percentage of Participants Reporting Absence of Phonophobia at 2 Hours Post-Dose on Migraine Treatment Day|Phonophobia is sensitivity to sound.|2 hours post dose 1|Full Analysis Set included all participants who received study treatment, had a Baseline headache severity measurement, and at least one post-dose efficacy measurement prior to, or including, the 2-hour time point.||percentage of participants||95% Confidence Interval|Number
673854|NCT01657370|Primary|Percentage of Participants With Pain Relief (PR) at 2 Hours Post-Dose on Migraine Treatment Day|PR was defined as a decrease from a moderate or severe migraine headache (Grade 2 or 3) at Baseline to a mild headache or no headache (Grade 1 or 0) 2 hours post dose. Headache severity was reported by the participant using a 4-point scale where: 0=no pain, 1=mild pain, 2=moderate pain and 3=severe pain.|2 hours post dose 1|Full Analysis Set included all participants who received study treatment, had a Baseline headache severity measurement, and at least one post-dose efficacy measurement prior to, or including, the 2-hour time point.||percentage of participants||95% Confidence Interval|Number
673855|NCT01657370|Primary|Percentage of Participants Reporting Pain Freedom (PF) at 2 Hours Post-Dose on Migraine Treatment Day|PF was defined as a decrease from a moderate or severe migraine headache (Grade 2 or 3) at Baseline to no pain (Grade 0) 2 hours post-dose. Headache severity was reported by the participant using a 4-point scale where: 0=no pain, 1=mild pain, 2=moderate pain and 3=severe pain.|2 hours post dose 1|Full Analysis Set included all participants who received study treatment, had a Baseline headache severity measurement, and at least one post-dose efficacy measurement prior to, or including, the 2-hour time point.||percentage of participants||95% Confidence Interval|Number
673856|NCT01657370|Primary|Dry Blood Spot (DBS) MK-1602 Concentration at 2 Hours Post-Dose on Migraine Treatment Day|The participant collected blood by fingerstick on a card. The card was sent to a laboratory and the concentration of MK-1602 determined using the dried blood spot (DBS) assay.|2 hours post dose 1|Participants from the Pharmacokinetic Analysis Population, all participant who received treatment, with data available for analysis.||nanomolar (nM)||Geometric Coefficient of Variation|Geometric Mean
673867|NCT01657292|Primary|Percentage of Patients With Earlier Healing of the Wound Half Treated With Oleogel-S10 Compared to the Wound Half Receiving Standard of Care|Photo-based evaluation by independent experts blinded to the treatment regime.|2 to 3 weeks|The analysis included all patients who were treated at least once with Oleogel-S10 or Octenilin® wound gel (as randomised) and for whom a difference in wound healing between the treatment was observed.||percentage of patients||95% Confidence Interval|Number
673868|NCT01657032|Secondary|Duration of Intravenous Therapy|need for intravenous rehydration therapy (how long if needed)|7days|||days||Inter-Quartile Range|Median
673869|NCT01657032|Secondary|Need for Intravenous Therapy|need for intravenous rehydration therapy (yes/no)|yes/no, for 7days|||participants|||Number
673870|NCT01657032|Secondary|Need for Hospitalization|If the child need to hospitalized|7 days|||participants|||Number
673871|NCT01657032|Secondary|Tolerance of Products|tolerance of products (whether the child took medicaments),|7days|||participants|||Number
673872|NCT01657032|Secondary|Diarrhea Recurrence|If the was a diarrhea recurrence during 7days|7 days|||participants|||Number
673873|NCT01657032|Secondary|Vomiting|How many times the child was vomiting (during the study)|how many times for 7days|||vomiting episodes||Inter-Quartile Range|Median
673874|NCT01657032|Secondary|Vomiting|If the child vomiting after randomization (yes/no)|yes/no, for 7days|||participants|||Number
673875|NCT01657032|Secondary|Need for Antibiotic Therapy,|need for antibiotic therapy because of diarrhea|yes/no, for 7days|||participants|||Number
673876|NCT01657032|Secondary|Consistency of Stools|"consistency of stools using Bristool Stool Scale Form on day 4-th. (The Bristol stool scale form is a medical aid designed to classify the form of human faeces into seven categories.
Type 1 Separate hard lumps, like nuts (hard to pass) Type 2 Sausage-shaped but lumpy Type 3 Like a sausage but with cracks on the surface Type 4 Like a sausage or snake, smooth and soft Type 5 Soft blobs with clear-cut edges Type 6 Fluffy pieces with ragged edges, a mushy stool Type 7 Watery, no solid pieces. Entirely liquid Types 1–2 indicate constipation, with 3 and 4 being the ideal stools (especially the latter), as they are easy to defecate while not containing any excess liquid, and 5, 6 and 7 tending towards diarrhoea."|day 4-th|||Units on a scale||Inter-Quartile Range|Median
673877|NCT01657032|Secondary|Frequency of Loose Stools,|number of loose stools during 7 days|number of loose stools during 7 days|||number of loose stools during 7days||Inter-Quartile Range|Median
673878|NCT01657032|Primary|Duration of Diarrhea|The primary outcome measure is duration of diarrhea (counted in days; from the first loose stool to the last one; end of diarrhea defined as last loose stool or at least 12hours without stool).|counted in days during 7days|||days||Inter-Quartile Range|Median
673879|NCT01657019|Secondary|Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Anxiety or Depression|The EQ-5D-5L is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health. The percentages of participants with various responses to the anxiety/depression questionnaire are reported. Percentages are based on all participants in the Full Analysis Set with a valid result at the given visit.|End of Treatment (ET; either Visit 16 [Week 52] or Early Termination)|The Full Analysis Set, defined as all participants in the Safety Analysis Set who had at least 1 post-Visit 0 clinical experience outcome assessment in this study. The Safety Analysis Set was defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.||percentage of participants at ET|||Number
673880|NCT01657019|Secondary|Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Pain and Discomfort|The EQ-5D-5L is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health. The percentages of participants with various responses to the pain/discomfort questionnaire are reported. Percentages are based on all participants in the Full Analysis Set with a valid result at the given visit.|End of Treatment (ET; either Visit 16 [Week 52] or Early Termination)|The Full Analysis Set, defined as all participants in the Safety Analysis Set who had at least 1 post-Visit 0 clinical experience outcome assessment in this study. The Safety Analysis Set was defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.||percentage of participants at ET|||Number
673881|NCT01657019|Secondary|Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Usual Activities|The EQ-5D-5L is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health. The percentages of participants with various responses to the usual activities questionnaire are reported. Percentages are based on all participants in the Full Analysis Set with a valid result at the given visit.|End of Treatment (ET; either Visit 16 [Week 52] or Early Termination)|The Full Analysis Set, defined as all participants in the Safety Analysis Set who had at least 1 post-Visit 0 clinical experience outcome assessment in this study. The Safety Analysis Set was defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.||percentage of participants at ET|||Number
673895|NCT01656967|Secondary|Time for Endotracheal Tube (ETT) Insertion|After the SGA is inserted, time for intubation will be recorded. Time for ETT insertion was measured, for arm 1, from when the AMBU aScope is at the connector level of the Aura-I or, for arm 2, from when the ETT is at the connector level of the Intubating LMA to first detection of CO2 on the capnogram. The AScope 2 disposable fiberoptic camera will be used to assist with intubation for Group 1 patients. Group 2 patients will be intubated using the LMA-Fastrach EndoTracheal Tube.|At ETT insertion|||seconds||Inter-Quartile Range|Median
673896|NCT01656967|Secondary|Time for Supraglottic Airway (SGA) Insertion|Time for SGA insertion was measured from when the tip of the cuff was at the mouth to detection of CO2 on the capnogram.|At SGA insertion|||seconds||Inter-Quartile Range|Median
673882|NCT01657019|Secondary|Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Self Care|The EQ-5D-5L is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health. The percentages of participants with various responses to the self care questionnaire are reported. Percentages are based on all participants in the Full Analysis Set with a valid result at the given visit.|End of Treatment (ET; either Visit 16 [Week 52] or Early Termination)|The Full Analysis Set, defined as all participants in the Safety Analysis Set who had at least 1 post-Visit 0 clinical experience outcome assessment in this study. The Safety Analysis Set was defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.||percentage of participants at ET|||Number
673883|NCT01657019|Secondary|Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Mobility|The EQ-5D-5L is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health. The percentages of participants with various responses to the mobility questionnaire are reported. Percentages are based on all participants in the Full Analysis Set with a valid result at the given visit.|End of Treatment (ET; either Visit 16 [Week 52] or Early Termination)|The Full Analysis Set, defined as all participants in the Safety Analysis Set who had at least 1 post-Visit 0 clinical experience outcome assessment in this study. The Safety Analysis Set was defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.||percentage of participants at ET|||Number
673884|NCT01657019|Secondary|Change From Baseline in The Global Score for The Eating Disorder Examination Questionnaire (EDE-Q)|The EDE-Q is a 28-item questionnaire measuring eating pathology and is derived directly from the Eating Disorder Examination Interview. The EDE-Q focuses on the past 28 days to assess the main behavioral (eating and purging) and attitudinal features of eating disorders. The 28 items are rated by the participant on a 7-point scale (ranging from 0 to 6), with higher scores indicating increased pathology. The EDE-Q includes 4 subscales: Restraint, Eating Concern, Weight Concern, and Shape Concern. The global score is the average of all 28 items, with a range of 0 to 6. A negative value indicates a favorable result. The values presented are the mean change from baseline.|Baseline, Weeks 4, 24, and 52, and end of treatment (either Visit 16 [Week 52] or Early Termination)|The Full Analysis Set, defined as all participants in the Safety Analysis Set who had at least 1 post-Visit 0 clinical experience outcome assessment in this study. The Safety Analysis Set was defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.||units on a scale||Standard Deviation|Mean
673885|NCT01657019|Secondary|Percentage of Participants With an Improved Response on The Clinical Global Impressions of Improvement (CGI-I) Scale|The CGI rating scales permitted the global evaluation of a participant’s condition severity and improvement over time. The CGI-I was performed to rate the improvement of a participant’s condition on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse) and included a ‘not assessed’ option. The responses were dichotomized into 2 categories (improved or not improved). Improved included very much improved and much improved; not improved included minimally improved, no change, minimally worse, much worse, and very much worse. Not assessed and missing values were excluded from the percentage calculation.|Weeks 1, 4, 24, and 52, and end of treatment (either Visit 16 [Week 52] or Early Termination)|The Full Analysis Set, defined as all participants in the Safety Analysis Set who had at least 1 post-Visit 0 clinical experience outcome assessment in this study. The Safety Analysis Set was defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.||percentage of participants||95% Confidence Interval|Number
673886|NCT01657019|Primary|Number of Participants With a Positive Response on The Columbia Suicide Severity Rating Scale (C-SSRS)|"Suicidality was assessed by using the C-SSRS, a semi-structured interview designed to capture the occurrence, severity, and frequency of suicide-related thoughts and behaviors. The interview and rating for the C-SSRS was completed by a clinician who had been successfully trained by the sponsor or designee. The interview was initiated with 5 (yes/no) questions, presented in ascending order of severity, about suicidal ideation. The most severe type of ideation was rated for frequency, duration, controllability, deterrents, and reason. If the answers to the first 2 ideation questions were “yes,” the clinician asked questions 3-5. Active suicidal ideation included any participant who answered yes to questions 2-5. If the answers to ideation questions 1 and 2 were “no,” then the clinician proceeded to 5 (yes/no) questions that addressed suicidal behavior, which was categorized as actual attempt, interrupted attempt, aborted attempt, preparatory acts or behaviors, and completed suicide."|53 weeks|The Safety Analysis Set, defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.||participants|||Number
673887|NCT01657019|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) as a Measure of Safety||52 weeks|The Safety Analysis Set was defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.||percentage of participants|||Number
673888|NCT01656967|Other Pre-specified|Orolaryngeal Pressure|The oropharyngeal leak pressure (OLP) was determined by closing the expiratory valve of the circle system at a fixed gas flow of 3 L/min and noting the airway pressure at which equilibrium was reached (not permitted to exceed 40 cm H2O).|Following SGA Insertion|||mmHg||Inter-Quartile Range|Median
673889|NCT01656967|Secondary|Post-Operative Discomfort Upon Leaving the Post-Anesthesia Care Unit (PACU)|The patient will be assessed for Post-Operative Hoarseness, Sore Mouth, Sore Neck, Sore Jaw, Dysphonia, Dysphagia, and Altered Tongue Sensation.|Approximately 1-2 hours after entering the PACU||||||
673890|NCT01656967|Secondary|Post-Operative Discomfort Upon Entering the Post-Anesthesia Care Unit (PACU)|The patient will be assessed for Post-Operative Hoarseness, Sore Mouth, Sore Neck, Sore Jaw, Dysphonia, Dysphagia, and Altered Tongue Sensation.|Within 30 minutes of completion of surgery||||||
673897|NCT01656967|Primary|Total Intubation Time|Total Intubation Time includes time for SGA insertion and for ETT insertion. The total time to intubation was measured from the beginning of SGA insertion to successful endotracheal tube intubation verified by detection of CO2 on the capnogram.|Duration of Intubation, including supraglottic airway (SGA) insertion and endotracheal tube (ETT) insertion|||seconds||Inter-Quartile Range|Median
673898|NCT01656889|Secondary|Compare the Efficacy of the Treatment Groups in Achieving Complete Wound Closure, Based on the Median Time (in Days) to Closure Over the 12-Week Treatment Period From Baseline.|This key secondary outcome was based on a Kaplan-Meier survival analysis.|12 weeks|ITT Populations: Subjects who received at least one dose of test article. Data were analyzed using a Kaplan-Meier Survival Analysis, with significance being at P < 0.05.||days to wound closure||Full Range|Median
673899|NCT01656889|Secondary|Change in Target Ulcer Pain|Target ulcer pain were measured using a Visual Analog Scale [Range: 0mm – 100mm]. Subjects marked their pain level on a 100 mm horizontal line, with a short vertical line across the scale, 0 denoting no pain and 100mm the maximum pain.|Weekly, over 12 week treament period, baseline|ITT Populations: Subjects who received at least one dose of test article. Data were analyzed by an ANCOVA, adjusted for site and baseline score.||units on a scale||Standard Error|Least Squares Mean
673900|NCT01656889|Secondary|Change in Pain Associated With the Target Leg at Each of the 12 Double Blind Treatment Weeks|Target leg pain were measured using a Visual Analog Scale [Range: 0mm – 100mm]. Subjects marked their pain level on a 100 mm horizontal line, with a short vertical line across the scale, 0 denoting no pain and 100mm the maximum pain.|Weekly, over the 12 week treatment period, baseline|ITT Populations: Subjects who received at least one dose of test article. Data were analyzed by an ANCOVA, adjusted for site and baseline score.||units on a scale||Standard Error|Least Squares Mean
673901|NCT01656889|Secondary|Number of Subjects With Durable Wound Healing Over the 3 Months Following Complete Wound Closure|Subjects who completed the treatment period with confirmed wound closure were followed in the post-treatment period for a further two months to determine their closed wound status (remained closed/reopened), giving a measure of persistence of wound closure following completion of treatment.|Target ulcer status observed at two and three months following initial ulcer closure.|"The 285 subjects (HP802-247: 141/222; Vehicle: 144/225) who completed the treatment period with confirmed wound closure.
Subjects returning for Visit 1 with confirmed wound closure at end of treatment: 134 HP802-247 and 132 Vehicle.
Subjects returning for Visit 2 with confirmed wound closure at end of treatment: 132 HP802-247 and 131 Vehicle"||participants|||Number
673902|NCT01656889|Secondary|Compare the Treatment Groups for the Percentage of Closed Ulcers at Each Visit of the 12-Week Treatment Period From Baseline|Treatment groups were compared for the proportion of wounds closed at each weekly visit. For subjects who dropped from the study, their remaining visit values were imputed using LOCF.|Weekly, over the 12 week treatment period, or until wound closure, which ever occurred first|ITT Populations: Subjects who received at least one dose of test article. Analysis was by the Cochrane Mantel Haenszel (CMH) test, adjusted for sites, with significance being at P < 0.05||percentage of Closed Ulcers|||Number
673903|NCT01656889|Secondary|Compare the Efficacy of the Treatment Groups in Achieving Complete Wound Closure, Based on Time in Days to Closure Over the 12-Week Treatment Period From Baseline.|This key secondary outcome was based on a Cox Proportional Hazard Analysis and a Kaplan-Meier survival analysis.|12 Weeks|ITT Populations: Subjects who received at least one dose of test article. Data were analyzed using the Cox Proportional hazard procedure, with significance being at P < 0.05 and by the Kaplan-Meier survival procedure||days||Full Range|Median
673904|NCT01656889|Primary|Compare the Treatment Groups for the Proportion of Subjects With Complete Wound Closure Over the 12-Week Treatment Period From Baseline|For each treatment group the area of each subject’s target ulcer was measured on a weekly basis, for up to 12 weeks, using a laser-based wound imaging system in conjunction with software to measure area. Following initial closure subjects returned for four weekly visits to confirm wound closure. Wounds that remained closed for four weeks were classified as confirmed closures; if a wound opened at any of the 4 visits it was not considered to have closed. For subjects who dropped from the study, their remaining visit values were imputed using LOCF; wound status of closed was not imputed.|12 Weeks|ITT Populations: Subjects who received at least one dose of test article. Analysis was by the Cochrane Mantel Haenszel (CMH) test, adjusted for sites, with significance being at P < 0.05||participants|||Number
673905|NCT01656850|Primary|Plasma Vitamin E Level at the Baseline and at the End of 3-month Dietary Intervention||at the baseline and at the end of 3-month dietary intervention|||μmol/L||Standard Deviation|Mean
673906|NCT01656850|Primary|Urine Isoproterenol Level at the Baseline and at the End of 3-month Dietary Intervention||at the baseline and at the end of 3-month dietary intervention|||ng/mg creatinine||Standard Deviation|Mean
673907|NCT01656850|Primary|Plasma Oxide LDL Level at the Baseline and at the End of 3-month Dietary Intervention||at the baseline and at the end of 3-month dietary intervention|||U/L||Standard Deviation|Mean
673908|NCT01656850|Primary|Plasma Protein Carbonyl Level at the Baseline and at the End of 3-month Dietary Intervention||at the baseline and at the end of 3-month dietary intervention|||nmol/mg||Standard Deviation|Mean
673909|NCT01656850|Primary|Endothelial Function at the Baseline and at the End of 3-month Dietary Intervention||at the baseline and at the end of 3-month dietary intervention|||ng/mL||Standard Deviation|Mean
673910|NCT01656850|Primary|Plasma Nitric Oxide Level at the Baseline and at the End of 3-month Dietary Intervention||at the baseline and at the end of 3-month dietary intervention|||μmol/L||Standard Deviation|Mean
673911|NCT01656850|Primary|Plasma Apolipoprotein Level at the Baseline and the End of 3-month Dietary Intervention||at the baseline and at the end of 3-month dietary intervention|||g/L||Standard Deviation|Mean
673912|NCT01656850|Primary|HOMA at the Baseline and the End of 3-month Dietary Intervention||at the baseline and at the end of 3-month dietary intervention|||pg/mL||Standard Deviation|Mean
673913|NCT01656850|Primary|Plasma HbA1c Level at the Baseline and the End of 3-month Dietary Intervention||at the baseline and at the end of 3-month dietary intervention|||percentage of hemoglubin||Standard Deviation|Mean
673914|NCT01656850|Primary|Area Under Curve of Plasma Insulin After Eating Standard Breakfast at the Baseline and at the End of 3-month Dietary Intervention||at the baseline and at the end of 3-month dietary intervention|||mU.min/L||Standard Deviation|Mean
673915|NCT01656850|Primary|Plasma Fasting Insulin at the Baseline and the End of 3-month Dietary Intervention||at the baseline and at the end of 3-month dietary intervention|||mU/L||Standard Deviation|Mean
673925|NCT01656772|Primary|Safety Outcome to be Assessed by Comparing the Rate of Adjudicated Serious Adverse Events Within 7 Days of the Procedure Between Both the Control and the Investigational Device Groups.|The Vdrive will allow physicians to manipulate compatible circular mapping catheters while maintaining a safety profile that is not inferior to manual circular catheter navigation. The one-sided null hypothesis was to be tested at the α = 0.05 significance level using a standard unpooled asymptotically normal test statistic. The null hypothesis was to be rejected if Z < -1.7046 or, equivalently, if the corresponding p-value was less than 0.05.|7 days Follow-up|||participants|||Number
673926|NCT01656772|Primary|The Primary Effectiveness Endpoint is the Successful Navigation and EGM Recording of Each Pre-specified Pulmonary Vein Per Procedure Between Both the Control and the Investigational Device Groups.|Success was navigating and sensing by obtaining an EGM at the pre-specified targeted PVs. The null hypothesis was to be tested at the α = 0.05 significance level using a test statistic Z based on the Farrington and Manning likelihood score statistic with adjustment to take into account the correlation between multiple observations (PVs) on the same subject. The null hypothesis was to be rejected if Z > 1.645 or, equivalently, if the corresponding p-value was less than 0.05.|Peri-procedural|All adverse events reported by the sites were independently adjudicated by the data safety monitory, DSM.||Pulmonary Veins|Participants||Number
673927|NCT01656759|Secondary|Postoperative Blood Loss|Measured as drainage output from postoperative drains during hospitalization.|3 days|||mL||Standard Deviation|Mean
673928|NCT01656759|Secondary|Total Transfusions|The number of transfusions each patient receives during their postoperative hospitalization.|3 days|||Number of transfusions|||Number
673929|NCT01656759|Primary|Total Blood Loss|Combination of intraoperative and postoperative blood loss for participants.|Collected during surgery and in first 2-3 days after surgery|||mL||Standard Deviation|Mean
673930|NCT01656759|Primary|Primary--Percent Change of Pre- to Post-Operative Hemoglobin|Pre-operative hemoglobin values from routine CBC no earlier than 1 month prior to surgery were compared to post-operative hemoglobin values from routine CBC after surgery.|Pre-operative to 1 month|||Percent Change||Standard Deviation|Mean
673931|NCT01656486|Primary|Decreased Secretions|Measurement of pancreatic panel, decreased Pancreatic Secretions|1 year|||participants|||Number
673932|NCT01656460|Primary|Early and Intermediate Toxicity for Dose Limiting Toxicity|"Any toxicity related to the radiation treatment will be scored and graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Serious adverse events will be captured from the time the patient signs consent until 12 weeks after the last SBRT.
DLTS: defined in protocol as: Dose limiting toxicities will be defined as grade 3 or greater treatment related pneumonitis, cardiac toxicity, bronchial injury or chest wall pain during or within 4 weeks of completion of SBRT."|3 months|||participants|||Number
673933|NCT01656434|Secondary|Change From Baseline in Body Weight|Participants' body weights were measured in a consistent manner throughout the trial, using standardized equirpment. Last In-Treatment Measurement refers to a participant's end of trial visit, the timing of which differed among participants.|Baseline and Week 52|Participants from All Subjects as Treated Population (all randomized participants who took at least one dose of trial medication) who had data available for Change from Baseline in Body Weight endpoint.||kilograms||Standard Error|Mean
673934|NCT01656434|Secondary|Number of Participants Who Experience at Least One Venous or Arterial Thrombotic/Thromboembolic Event||Up to 54 weeks|All Subjects as Treated Population, which consisted of all randomized participants who took at least one dose of trial medication. One treated participant in the NOMAC-E2 treatment group had incomplete data and was not included in the Safety Analyses.||Participants|||Number
673935|NCT01656434|Secondary|Percentage of Participants Who Experienced At Least One Adverse Event|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.|Up to 54 weeks|All Subjects as Treated Population, which consisted of all randomized participants who took at least one dose of trial medication. One treated participant in the NOMAC-E2 treatment group had incomplete data and was not included in the Safety Analyses.||Percentage of Participants|||Number
673936|NCT01656434|Secondary|Percentage of Participants With an Absence of Withdrawal Bleeding|Participants kept e-diaries to record vaginal bleeding events. They were asked to record, on a daily basis, whether vaginal bleeding was present. Absence of withdrawal bleeding was defined as no bleeding/spotting during the expected bleeding period.|Up to 1 year (13 cycles)|Planned analysis for this secondary endpoint was not performed due to early study termination.|||||
673937|NCT01656434|Secondary|Percentage of Participants With an Occurrence of Breakthrough Bleeding/Spotting|"Participants kept e-diaries to record their vaginal bleeding events. They were asked to record, on a daily basis, whether they experienced vaginal bleeding, which included BLEEDING or SPOTTING, at any time during a cycle other than normal menstruation while in the study. (This is also known as breakthough bleeding.) Vaginal bleeding that required >=1 pad/tampon per day was classified as BLEEDING. Vaginal bleeding that did not require a pad/tampon per day was classified as SPOTTING."|Up to 1 year (13 cycles)|Planned analysis for this secondary endpoint was not performed due to early study termination.|||||
673938|NCT01656434|Primary|Number of In-Treatment Pregnancies Per 100 Woman Years of Exposure (Pearl Index)|Primary Efficacy Outcome measure for this study was contraceptive efficacy, or the prevention of in-treatment pregnancy. The total incidence of in-treatment pregnancies was expressed as the Pearl Index, which is defined as the number of in-treatment pregnancies per 100 woman-years of exposure.|Up to 1 year (13 cycles)|Planned analysis for this primary endpoint was not performed due to early study termination.|||||
673939|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs pDBP in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel J)|pDBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pDBP value by that pDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||mm Hg||Standard Error|Least Squares Mean
673940|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs pSBP Following Day 28 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel J)|pSBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pSBP value by that pSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||mm Hg||Standard Error|Least Squares Mean
673941|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs cDBP Following Day 28 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel J)|cDBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cDBP value by that cDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||mmHg||Standard Error|Least Squares Mean
673942|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs AIx Following Day 28 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel J)|AIx was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Augmentation index is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. Time-weighted average was obtained as follows: For all AIx values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each AIx value by that AIx value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified AIx value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. AIx was adjusted for HR. Baseline was Day 1 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||percentage of central pulse pressure||Standard Error|Least Squares Mean
673943|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs pDBP Following Day 28 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel I)|pDBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pDBP value by that pDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||mm Hg||Standard Error|Least Squares Mean
673944|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs pSBP Following Day 28 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel I)|pSBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pSBP value by that pSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||mm Hg||Standard Error|Least Squares Mean
673945|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs cDBP Following Day 28 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel I)|cDBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cDBP value by that cDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||mm Hg||Standard Error|Least Squares Mean
673972|NCT01656408|Primary|Tmax of MK-8150 in Male and Female Participants With Resistant Hypertension Administered Multiple Doses of MK-8150 (Panel H)|Serial plasma samples for determination of PK parameters were obtained from study participants. Tmax of MK-8150 on Day 1 and Day 10 was determined from the observed plasma concentration-time data.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose, and (for Day 10 only) 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||hr||Full Range|Median
674257|NCT01652716|Secondary|Change in Fasting Plasma Glucose Concentrations From Baseline to Week 28|Change in fasting plasma glucose concentrations from baseline to Week 28/Study Termination|Baseline to Week 28|Modified Intent-to-Treat: Subjects who were randomized and received at least one dose of study drug.||mg/dL||Standard Error|Least Squares Mean
673946|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs AIx in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel I)|AIx was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Augmentation index is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. Time-weighted average was obtained as follows: For all AIx values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each AIx value by that AIx value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified AIx value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. AIx was adjusted for HR. Baseline was Day 1 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||percentage of pulse pressure||Standard Error|Least Squares Mean
673947|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs pDBP Following Day 10 Dose in Male and Female Participants With Resistant Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel H)|pDBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pDBP value by that pDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value (determined separately in each period).|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||mm Hg||Standard Error|Least Squares Mean
673948|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs pSBP Following Day 10 Dose in Male and Female Participants With Resistant Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel H)|pSBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pSBP value by that pSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value (determined separately in each period).|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||mm Hg||Standard Error|Least Squares Mean
673949|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs cDBP Following Day 10 Dose in Male and Female Participants With Resistant Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel H)|cDBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cDBP value by that cDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value (determined separately in each period).|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||mm Hg||Standard Error|Least Squares Mean
673950|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs AIx in Male and Female Participants With Resistant Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel H)|AIx was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Augmentation index is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. Time-weighted average was obtained as follows: For all AIx values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each AIx value by that AIx value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified AIx value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. AIx was adjusted for HR. Baseline was Day 1 pre-dose value (determined separately in each period).|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||percentage of central pulse pressure||Standard Error|Least Squares Mean
673951|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs pDBP Following Day 28 Dose in Healthy Male Participants Administered Multiple Doses of MK-8150 and Placebo (Panel G)|pDBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pDBP value by that pDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||mm Hg||Standard Error|Least Squares Mean
673973|NCT01656408|Primary|Cmax of MK-8150 in Male and Female Participants With Resistant Hypertension Administered Multiple Doses of MK-8150 (Panel H)|Serial plasma samples for determination of PK parameters were obtained from study participants. Cmax of MK-8150 on Day 1 and Day 10 was determined from the observed plasma concentration-time data.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose, and (for Day 10 only) 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||μM||Geometric Coefficient of Variation|Geometric Mean
673952|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs pSBP Following Day 28 Dose in Healthy Male Participants Administered Multiple Doses of MK-8150 and Placebo (Panel G)|pSBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pSBP value by that pSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||mm Hg||Standard Error|Least Squares Mean
673953|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs cDBP Following Day 28 Dose in Healthy Male Participants Administered Multiple Doses of MK-8150 and Placebo (Panel G)|cDBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cDBP value by that cDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||mm Hg||Standard Error|Least Squares Mean
673954|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs AIx in Healthy Male Participants Administered Multiple Doses of MK-8150 and Placebo (Panel G)|AIx was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Augmentation index is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. Time-weighted average was obtained as follows: For all AIx values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each AIx value by that AIx value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified AIx value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. AIx was adjusted for HR. Baseline was Day 1 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||percentage of central pulse pressure||Standard Error|Least Squares Mean
673955|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs pDBP Following Day 15 Dose in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel F)|pDBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pDBP value by that pDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||mm Hg||Standard Error|Least Squares Mean
673956|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs pSBP Following Day 15 Dose in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel F)|pSBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pSBP value by that pSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||mm Hg||Standard Error|Least Squares Mean
673957|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs cDBP Following Day 15 Dose in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel F)|cDBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cDBP value by that cDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||mm Hg||Standard Error|Least Squares Mean
673974|NCT01656408|Primary|AUC0-24 of MK-8150 in Male and Female Participants With Resistant Hypertension Administered Multiple Doses of MK-8150 (Panel H)|Serial plasma samples for determination of PK parameters were obtained from study participants. AUC0-24 of MK-8150 on Day 1 and Day 10 was determined.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||μM*hr||Geometric Coefficient of Variation|Geometric Mean
675995|NCT01631825|Secondary|Each Item of UPDRS Part 2 (Off State)|The percentage of subjects with elevated scores for each item of UPDRS Part 2 (off state). The data at week 52 is shown.|Baseline, up to 54 weeks after dosing.|FAS, LOCF||Percentage of Participants|||Number
673958|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs AIx in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel F)|AIx was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Augmentation index is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. Time-weighted average was obtained as follows: For all AIx values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each AIx value by that AIx value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified AIx value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. AIx was adjusted for HR. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||percentage of central pulse pressure||Standard Error|Least Squares Mean
673959|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs pDBP Following Day 15 Dose in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel E)|pDBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pDBP value by that pDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||mm Hg||Standard Error|Least Squares Mean
673960|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs pSBP Following Day 15 Dose in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel E)|pSBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pSBP value by that pSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||mm Hg||Standard Error|Least Squares Mean
673961|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs cDBP Following Day 15 Dose in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel E)|cDBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cDBP value by that cDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||mm Hg||Standard Error|Least Squares Mean
673962|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs AIx in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel E)|AIx was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Augmentation index is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. Time-weighted average was obtained as follows: For all AIx values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each AIx value by that AIx value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified AIx value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. AIx was adjusted for HR. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||percentage of central pulse pressure||Standard Error|Least Squares Mean
673963|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs pDBP Following Day 10 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel A/B/C/D)|pDBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pDBP value by that pDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||mm Hg||Standard Error|Least Squares Mean
674016|NCT01656252|Other Pre-specified|Exploratory- Eltrombopag Effect on TPO/EPO|To determine if eltrombopag has an effect on TPO and/or EPO in this setting.|62 months||||||
673964|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs pSBP Following Day 10 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel A/B/C/D)|pSBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pSBP value by that pSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||mm Hg||Standard Error|Least Squares Mean
673965|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs cDBP Following Day 10 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel A/B/C/D)|cDBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cDBP value by that cDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||mm Hg||Standard Error|Least Squares Mean
673966|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs AIx in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel A/B/C/D)|AIx was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Augmentation index is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. Time-weighted average was obtained as follows: For all AIx values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each AIx value by that AIx value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified AIx value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. AIx was adjusted for HR. Baseline was Day 1 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||percentage of central pulse pressure||Standard Error|Least Squares Mean
673967|NCT01656408|Primary|t1/2 of MK-8150 Determined Following Day 28 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel I/J, Including Only Participants Who Completed Treatment)|Serial plasma samples for determination of PK parameters were obtained from study participants. t1/2 is the time it takes for the concentration of the drug in the body to decrease by half during the elimination phase. t1/2 of MK-8150 was determined from plasma drug concentration data obtained following the last dose of study drug, administered on Day 28.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and completed the 28 days of treatment, and had data available for the measure||hr||Geometric Coefficient of Variation|Geometric Mean
673968|NCT01656408|Primary|Tmax of MK-8150 in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel I/J, Including Only Participants Who Completed Treatment)|Serial plasma samples for determination of PK parameters were obtained from study participants. Tmax of MK-8150 on Day 1 and Day 28 was determined from the observed plasma concentration-time data.|Day 1: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose; Day 28: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and completed the 28 days of treatment, and had data available for the measure||hr||Full Range|Median
673969|NCT01656408|Primary|Cmax of MK-8150 in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel I/J, Including Only Participants Who Completed Treatment)|Serial plasma samples for determination of PK parameters were obtained from study participants. Cmax of MK-8150 on Day 1 and Day 28 was determined from the observed plasma concentration-time data.|Day 1: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose; Day 28: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and completed the 28 days of treatment, and had data available for the measure||μM||Geometric Coefficient of Variation|Geometric Mean
673970|NCT01656408|Primary|AUC0-24 of MK-8150 in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel I/J, Including Only Participants Who Completed Treatment)|Serial plasma samples for determination of PK parameters were obtained from study participants. AUC0-24 of MK-8150 on Day 1 and Day 28 was determined.|Day 1: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose; Day 28: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and completed the 28 days of treatment, and had data available for the measure||μM*hr||Geometric Coefficient of Variation|Geometric Mean
673971|NCT01656408|Primary|t1/2 of MK-8150 Determined Following Day 10 Dose in Male and Female Participants With Resistant Hypertension Administered Multiple Doses of MK-8150 (Panel H)|Serial plasma samples for determination of PK parameters were obtained from study participants. t1/2 is the time it takes for the concentration of the drug in the body to decrease by half during the elimination phase. t1/2 of MK-8150 was determined from plasma drug concentration data obtained following the last dose of study drug, administered on Day 10.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||hr||Geometric Coefficient of Variation|Geometric Mean
674017|NCT01656252|Secondary|Phase II- Safety of Eltrombopag With Consolidation|To determine the safety and tolerability of eltrombopag when given at the optimal dose in the setting of consolidation chemotherapy.|62 months||||||
673975|NCT01656408|Primary|t1/2 of MK-8150 Determined Following Day 28 Dose in Healthy Male Participants Administered Multiple Doses of MK-8150 (Panel G)|Serial plasma samples for determination of PK parameters were obtained from study participants. t1/2 is the time it takes for the concentration of the drug in the body to decrease by half during the elimination phase. t1/2 of MK-8150 was determined from plasma drug concentration data obtained following the last dose of study drug, administered on Day 28.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||hr||Geometric Coefficient of Variation|Geometric Mean
673976|NCT01656408|Primary|Tmax of MK-8150 in Healthy Male Participants Administered Multiple Doses of MK-8150 (Panel G)|Serial plasma samples for determination of PK parameters were obtained from study participants. Tmax of MK-8150 on Day 1 and Day 28 was determined from the observed plasma concentration-time data.|Day 1: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose; Day 28: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||hr||Full Range|Median
673977|NCT01656408|Primary|Cmax of MK-8150 in Healthy Male Participants Administered Multiple Doses of MK-8150 (Panel G)|Serial plasma samples for determination of PK parameters were obtained from study participants. Cmax of MK-8150 on Day 1 and Day 28 was determined from the observed plasma concentration-time data.|Day 1: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose; Day 28: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||μM||Geometric Coefficient of Variation|Geometric Mean
673978|NCT01656408|Primary|AUC0-24 of MK-8150 in Healthy Male Participants Administered Multiple Doses of MK-8150 (Panel G)|Serial plasma samples for determination of PK parameters were obtained from study participants. AUC0-24 of MK-8150 on Day 1 and Day 28 was determined.|Day 1: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose; Day 28: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||μM*hr||Geometric Coefficient of Variation|Geometric Mean
673979|NCT01656408|Primary|t1/2 of MK-8150 Determined Following Day 15 Dose in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel E/F, Days 6-15)|Serial plasma samples for determination of PK parameters were obtained from study participants. t1/2 is the time it takes for the concentration of the drug in the body to decrease by half during the elimination phase. t1/2 of MK-8150 was determined from plasma drug concentration data obtained following the last dose of study drug, administered on Day 15.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||hr||Geometric Coefficient of Variation|Geometric Mean
673980|NCT01656408|Primary|Tmax of MK-8150 in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel E/F, Days 6-15)|Serial plasma samples for determination of PK parameters were obtained from study participants. Tmax of MK-8150 on Day 6 and Day 15 was determined from the observed plasma concentration-time data.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose, and (for Day 15 only) 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||hr||Full Range|Median
673981|NCT01656408|Primary|Cmax of MK-8150 in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel E/F, Days 6-15)|Serial plasma samples for determination of PK parameters were obtained from study participants. Cmax of MK-8150 on Day 6 and Day 15 was determined from the observed plasma concentration-time data.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose, and (for Day 15 only) 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||μM||Geometric Coefficient of Variation|Geometric Mean
673982|NCT01656408|Primary|AUC0-24 of MK-8150 in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel E/F, Days 6-15)|Serial plasma samples for determination of PK parameters were obtained from study participants. AUC0-24 of MK-8150 on Day 6 and Day 15 was determined.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||μM*hr||Geometric Coefficient of Variation|Geometric Mean
673983|NCT01656408|Primary|t1/2 of MK-8150 in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single Doses of MK-8150 (Panel E/F, Day 1 Dose)|Serial plasma samples for determination of PK parameters were obtained from study participants. t1/2 is the time it takes for the concentration of the drug in the body to decrease by half during the elimination phase. t1/2 of MK-8150 was determined from plasma drug concentration data obtained following the Day 1 dose.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||hr||Geometric Coefficient of Variation|Geometric Mean
673984|NCT01656408|Primary|Tmax of MK-8150 in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single Doses of MK-8150 (Panel E/F, Day 1 Dose)|Serial plasma samples for determination of PK parameters were obtained from study participants. Tmax of MK-8150 on Day 1 was determined from the observed plasma concentration-time data.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||hr||Full Range|Median
673985|NCT01656408|Primary|Cmax of MK-8150 in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single Doses of MK-8150 (Panel E/F, Day 1 Dose)|Serial plasma samples for determination of PK parameters were obtained from study participants. Cmax of MK-8150 on Day 1 was determined from the observed plasma concentration-time data.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||μM||Geometric Coefficient of Variation|Geometric Mean
674018|NCT01656252|Secondary|Phase II- Duration of Platelet Nadir|To determine the duration of platelet nadir in the setting of eltrombopag exposure.|62 months||||||
674019|NCT01656252|Secondary|Phase II- Depth of Platelet Nadir|To determine the impact of eltrombopag on the depth of platelet nadir following a cycle of consolidation chemotherapy.|62 months||||||
673986|NCT01656408|Primary|AUC0-24 of MK-8150 in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single Doses of MK-8150 (Panel E/F, Day 1 Dose)|Serial plasma samples for determination of PK parameters were obtained from study participants. AUC0-24 of MK-8150 on Day 1 was determined.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||μM*hr||Geometric Coefficient of Variation|Geometric Mean
673987|NCT01656408|Primary|Apparent Terminal Half-life (t1/2) of MK-8150 Determined Following Day 10 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel A/B/C/D)|Serial plasma samples for determination of PK parameters were obtained from study participants. t1/2 is the time it takes for the concentration of the drug in the body to decrease by half during the elimination phase. t1/2 of MK-8150 was determined from plasma drug concentration data obtained following the last dose of study drug, administered on Day 10.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||hr||Geometric Coefficient of Variation|Geometric Mean
673988|NCT01656408|Primary|Time to Maximum Observed Plasma Concentration (Tmax) of MK-8150 in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel A/B/C/D)|Serial plasma samples for determination of PK parameters were obtained from study participants. Tmax of MK-8150 on Day 1 and Day 10 was determined from the observed plasma concentration-time data.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose, and (for Day 10 only) 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||hr||Full Range|Median
673989|NCT01656408|Primary|Maximum Observed Plasma Concentration (Cmax) of MK-8150 in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel A/B/C/D)|Serial plasma samples for determination of PK parameters were obtained from study participants. Cmax of MK-8150 on Day 1 and Day 10 was determined from the observed plasma concentration-time data.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose, and (for Day 10 only) 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||μM||Geometric Coefficient of Variation|Geometric Mean
673990|NCT01656408|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC0-24) of MK-8150 in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel A/B/C/D)|Serial plasma samples for determination of PK parameters were obtained from study participants. AUC0-24 of MK-8150 on Day 1 and Day 10 was determined.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||μM*hr||Geometric Coefficient of Variation|Geometric Mean
673991|NCT01656408|Primary|Change From Baseline in TWA0-24hrs HR in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel J)|HR was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all HR values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each HR value by that HR value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified HR value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||beats per minute||Standard Error|Least Squares Mean
673992|NCT01656408|Primary|Change From Baseline in TWA0-24hrs cSBP in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel J)|cSBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cSBP value by that cSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||mm Hg||Standard Error|Least Squares Mean
673993|NCT01656408|Primary|Change From Baseline in TWA0-24hrs HR in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel I)|HR was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all HR values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each HR value by that HR value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified HR value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||beats per minute||Standard Error|Least Squares Mean
673994|NCT01656408|Primary|Change From Baseline in TWA0-24hrs cSBP in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel I)|cSBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cSBP value by that cSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||mm Hg||Standard Error|Least Squares Mean
673995|NCT01656408|Primary|Change From Baseline in TWA0-24hrs HR in Male and Female Participants With Resistant Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel H)|HR was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all HR values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each HR value by that HR value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified HR value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value (determined separately in each period).|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||beats per minute||Standard Error|Least Squares Mean
673996|NCT01656408|Primary|Change From Baseline in TWA0-24hrs cSBP in Male and Female Participants With Resistant Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel H)|cSBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cSBP value by that cSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value (determined separately in each period).|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||mm Hg||Standard Error|Least Squares Mean
673997|NCT01656408|Primary|Change From Baseline in TWA0-24hrs HR in Healthy Male Participants Administered Multiple Doses of MK-8150 and Placebo (Panel G)|HR was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all HR values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each HR value by that HR value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified HR value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||beats per minute||Standard Error|Least Squares Mean
673998|NCT01656408|Primary|Change From Baseline in TWA0-24hrs cSBP in Healthy Male Participants Administered Multiple Doses of MK-8150 and Placebo (Panel G)|cSBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cSBP value by that cSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||mm Hg||Standard Error|Least Squares Mean
673999|NCT01656408|Primary|Change From Baseline in TWA0-24hrs HR in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel F)|HR was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all HR values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each HR value by that HR value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified HR value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||beats per minute||Standard Error|Least Squares Mean
674000|NCT01656408|Primary|Change From Baseline in TWA0-24hrs cSBP in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel F)|cSBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cSBP value by that cSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||mm Hg||Standard Error|Least Squares Mean
674001|NCT01656408|Primary|Change From Baseline in TWA0-24hrs HR in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel E)|HR was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all HR values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each HR value by that HR value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified HR value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||beats per minute||Standard Error|Least Squares Mean
674002|NCT01656408|Primary|Change From Baseline in TWA0-24hrs cSBP in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel E)|cSBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cSBP value by that cSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||mm Hg||Standard Error|Least Squares Mean
674003|NCT01656408|Primary|Change From Baseline in TWA0-24hrs HR in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel A/B/C/D)|HR was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all HR values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each HR value by that HR value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified HR value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||beats per minute||Standard Error|Least Squares Mean
674004|NCT01656408|Primary|Change From Baseline in Time-weighted Average Across 24 Hours (TWA0-24hrs) cSBP in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel A/B/C/D)|cSBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cSBP value by that cSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||mm Hg||Standard Error|Least Squares Mean
674005|NCT01656408|Primary|Number of Participants Discontinued From Study Drug Due to Meeting Hemodynamic Stopping Rules|Hemodynamic criteria for stopping drug dosing were applied (any of the following, obtained resting and if present for ≥1 hour, unless noted). For all Panels: HR >120 bpm; SBP ≥180 mm Hg (Panels A-D/G-J) and ≥175 mm Hg (Panels E-F); DBP ≥110 mm Hg; DBP <50 mm Hg; SBP <90 mm Hg or participant placed in Trendelenburg position. For Panels A-H: HR increase over identified baseline of ≥25 beats per minute; SBP reduction >30 mm Hg versus identified baseline; >20 mm Hg drop in SBP and >20 beats per minute rise in HR observed together versus identified baselines; >30 mm Hg drop in orthostatic SBP and >30 beats per minute rise in orthostatic HR observed together. For Panels I-J, any of the following-down dosing criteria if still present 24 hours after dose decrease: HR increase ≥20 beats per minute versus identified baseline; SBP reduction >30 mm Hg versus identified baseline; SBP <100 mm Hg; >30 mm Hg drop in orthostatic SBP and >30 beats per minute rise in orthostatic HR observed together.|Up to 28 days|All participants who received at least one dose of study drug||participants|||Number
674006|NCT01656408|Primary|Number of Participants With an Adverse Event (AE)|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE. The 8 crossover Panel H participants are represented in both Panel H – MK-8150 10/20 mg column and Placebo (Panel A - J) column.|Up to 14 days after the last dose (Up to approximately 42 days, excluding pre-dose/screening period)|All participants who received at least one dose of study drug||participants|||Number
674007|NCT01656304|Secondary|Correlation of Urine NTX and Serum BSAP Levels With Time to PSA Progression||Baseline, week 7 or 12 and post-therapy||||||
674008|NCT01656304|Secondary|Changes in Levels of N Terminal Collagen Peptide and Bone-specific Alkaline Phosphatase With Bevacizumab Therapy||Baseline, week 7 or 12, and post-therapy||||||
674009|NCT01656304|Secondary|Circulating Tumor Cell Count||Baseline, at week 12||||||
674010|NCT01656304|Secondary|Time to Distant Metastatic Disease||Every 3 months||||||
674011|NCT01656304|Secondary|The Change in PSA Velocity With Bevacizumab Therapy in Androgen Independent Non-metastatic Prostate Cancer||Baseline, every 6 weeks while on therapy, and then every 3 months thereafter||||||
674012|NCT01656304|Secondary|Overall Survival of Androgen Independent Non-metastatic Prostate Cancer Patients Treated With Bevacizumab||Every 3 months||||||
674013|NCT01656304|Primary|Time to PSA Progression (TTPP)|TTPP will be measured from protocol registration to appearance of PSA progression as defined by the criteria of the PSA Working Group response criteria. The end point for progression will be calculated at the time a 25% increase in PSA has been achieved. PSA velocity will also be calculated as change in PSA doubling time pre and post therapy and the rate of PSA rise pre- and post-therapy.|An average every 6 weeks for up to 3 months|||months||90% Confidence Interval|Median
674014|NCT01656304|Primary|Toxicities Associated With Bevacizumab Therapy|Toxicity rates will be summarized by point estimates and Wilson type 80% confidence intervals. Toxicities will be graded per the National Cancer Institute (NCI) Common Toxicity Criteria (CTC), and PSA response will be determined as per PSA Working Group response criteria. Censored time to PSA progression will be estimated with standard Kaplan-Meier methodology.|An average of every 2 weeks while on therapy|||participants|||Number
674015|NCT01656304|Primary|PSA Response Rate With Bevacizumab Therapy in Androgen Independent Non-metastatic Prostate Cancer|Response rates will be summarized by point estimates and Wilson type 80% confidence intervals.|An average every 6 weeks for up to 3 months|||participants|||Number
674026|NCT01656252|Primary|Phase I - Dose Level With Best Kinetics of Platelet Count Recovery|To describe the kinetics of platelet count recovery in acute myeloid leukemia patients in complete remission receiving intensive consolidation chemotherapy who will be receiving eltrombopag. This is assessed graphically by plotting platelet count vs. days relative to start of cytarabine for each patient.|13 months|||mg|||Number
674027|NCT01656252|Primary|Phase I- Optimal Tolerated Dose of Eltrombopag|To determine the safety, tolerability and optimal dose of eltrombopag in acute myeloid leukemia patients in complete remission receiving intensive consolidation chemotherapy. The optimal dose was based on rules involving observation of Dose Limiting Toxicity (DLT events), defined as a CTCAE Version 4 non-hematologic adverse event of grade 3 or higher occurring within 30 days of the last dose of eltrombopag judged by the investigator to be at least possibly related to eltrombopag administration.|13 months|||mg|||Number
674028|NCT01656161|Secondary|Triptorelin PK Metrics for Both Injections: Concentration 0 Hour||Days 1-169 and Days 169-337|Participants in the PK/PD subset with a measured value.||ng/mL||95% Confidence Interval|Geometric Mean
674029|NCT01656161|Secondary|Triptorelin PK Metrics for Both Injections: Cmax||Days 1-169 and Days 169-337|||ng/mL||95% Confidence Interval|Geometric Mean
674030|NCT01656161|Secondary|Triptorelin PK Metrics for Both Injections: Area Under the Concentration vs Time Curve (AUC)||Days 1-169 and Days 169-337|||days * ng/mL||95% Confidence Interval|Geometric Mean
674031|NCT01656161|Secondary|Testosterone PD Metrics for First Injection: Time to Castration (Tcast)||Days 1-169|||days||95% Confidence Interval|Geometric Mean
674032|NCT01656161|Secondary|Testosterone PD Metrics for First Injection: Time to Peak Serum/Plasma Concentration (Tmax)||Days 1-169|PK/PD subset of 15 participants||hours||95% Confidence Interval|Median
674033|NCT01656161|Secondary|Testosterone PD Metrics for First Injection: Maximum Concentration (Cmax)||Days 1-169|||nmol/L||95% Confidence Interval|Geometric Mean
674034|NCT01656161|Secondary|Testosterone Pharmacodynamic (PD) Metrics for First Injection: Area Under the Concentration vs Time Curve (AUC)||Days 1-169|||day*nmol/L||95% Confidence Interval|Geometric Mean
674035|NCT01656161|Secondary|Number of Participants Who Presented a Real “Acute-on-chronic” (AOC) Phenomenon (Testosterone Levels ≥ 1.735 Nmol/L 48 Hours After the Second Injection While Previously Castrated)||Day 171|||participants|||Number
674036|NCT01656161|Secondary|Percentage Change From Baseline in Prostate Specific Antigen (PSA) Through Day 337||Baseline through Day 337|ITT population with a measured value at each specified time point||percentage of change in PSA levels||Standard Deviation|Mean
674037|NCT01656161|Secondary|Percentage of Participants Showing ≤ 1.0 IU/L Increase in Serum Luteinising Hormone (LH) From 0 Hour to 2 Hours Post-injection on Day 1 and Day 169||on Days 1 and 169|Intention to treat (ITT) population with a measured value at the time analysed||percentage of participants||95% Confidence Interval|Number
674038|NCT01656161|Primary|Percentage of Participants Achieving and Maintaining Castrate Levels of Serum Testosterone (<1.735 Nmol/L)||within 337 days|Intention to treat population||Percentage of Participants||95% Confidence Interval|Number
674039|NCT01656031|Primary|Measure Patient Response to High-dose Cytarabine Followed by Clofarabine in Adult Patients With Relapsed or Refractory AML|Response to the therapy is measured by a defined improvement in Neutrophil and platlet counts, along with improved cellularity of bone marrow biopsy (>20% with maturation of all cell lines), <5% blasts, auer rods must not be detectable and extramedullary leukemia or soft tissue involvment must not be present.|5 weeks|||participants|||Number
674040|NCT01655498|Secondary|Device-related Adverse Events|The number of overall adverse events rated as probably or definitely related to the study device.|1month|All subjects who were exposed to the VBC device (now called Eclipse) during the Treatment Period.||events|||Number
674041|NCT01655498|Secondary|Number of Incontinent Days|Change in number of incontinent days while wearing the device during the 2-week assessment period as compared to the baseline 2-week assessment period|1 Month|||days||Standard Deviation|Mean
674042|NCT01655498|Primary|Frequency of FI Episodes|Subjects with at least a 50% reduction in FI episodes (major or minor soiling)|1 Month|Subjects who were successfully fit with the VBC device.||percentage of participants|||Number
674043|NCT01655381|Secondary|Percentage of Participants With Clinically Meaningful Improvement From Baseline in HAQ-DI|"Clinically meaningful improvement was defined as an improvement in HAQ-DI score of ≥0.22.
HAQ-DI is the participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty."|Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140|The included population includes all participants who entered the study. All included participants were part of safety population. Here, n = number of participants who were evaluable at specific time points.||percentage of participants|||Number
674044|NCT01655381|Secondary|Percentage of Participants With Health Assessment Questionnaire Disability Index (HAQ-DI) Remission|"HAQ-DI remission was defined as HAQ-DI score <0.5.
HAQ-DI is the participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty."|Baseline and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128 140|The included population includes all participants who entered the study. All included participants were part of safety population. Here, n = number of participants who were evaluable at specific time points.||percentage of participants|||Number
674045|NCT01655381|Secondary|Physicians’ Global Assessment of Disease Activity (VAS) Score|The physicians’ global assessment of disease activity (VAS) was assessed using a 100-mm horizontal VAS with 0=no disease activity to 100=maximum disease.|Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140|The included population includes all participants who entered the study. All included participants were part of safety population. Here, n = number of participants who were evaluable at specific time points.||units on a scale||Full Range|Median
685589|NCT01499810|Secondary|Change in Mean 24-h Systolic BP||from baseline to 6 months|Number of participants assessed at 6 months minus 2 participants with unsatisfactory ABPM records||mmHg||Standard Deviation|Mean
674046|NCT01655381|Secondary|Participants’ Global Assessment of Disease Activity (VAS) Score|The participants’ global assessment of disease activity (VAS) was assessed using a 100-mm horizontal VAS with 0=no disease activity to 100=maximum disease.|Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140|The included population includes all participants who entered the study. All included participants were part of safety population. Here, n = number of participants who were evaluable at specific time points.||units on a scale||Full Range|Median
674047|NCT01655381|Secondary|Participants’ Global Assessment of Pain (VAS) Score|The participants’ global assessment of pain (VAS) was assessed using a 100-mm horizontal VAS with 0=no pain to 100=maximum pain.|Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140|The included population includes all participants who entered the study. All included participants were part of safety population. Here, n = number of participants who were evaluable at specific time points.||units on a scale||Full Range|Median
674048|NCT01655381|Secondary|C-reactive Protein (CRP) Level|C-reactive protein (CRP) is a blood test marker for inflammation in the body. Normal CRP levels are below 5 milligrams per liter (mg/L). Higher scores correspond to greater disease activity.|Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140|The included population includes all participants who entered the study. All included participants were part of safety population. Here, n = number of participants who were evaluable at specific time points.||mg/L||Full Range|Median
674049|NCT01655381|Secondary|Erythrocyte Sedimentation Rate (ESR) Over Time|ESR is an direct measure of how much inflammation is in the body. The normal range is 0-22 mm/hour for men and 0-29 mm/hour for women. Higher scores correspond to greater disease activity.|Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140|The included population includes all participants who entered the study. All included participants were part of safety population. Here, n = number of participants who were evaluable at specific time points.||mm/hour||Full Range|Median
674050|NCT01655381|Secondary|Change From Day 1 in Swollen Joint Count Based on 28 Joints (SJC28) Over Time|The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1; total was calculated by adding all the joints for a maximum score of 28 swollen joints. Higher scores correspond to greater disease activity.|Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140|The included population includes all participants who entered the study. All included participants were part of safety population. Here, n = number of participants who were evaluable at specific time points.||swollen joints||Standard Deviation|Mean
674051|NCT01655381|Secondary|Change From Day 1 in Tender Joint Count Based on 28 Joints (TJC28) Over Time|The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1; total was calculated by adding all the joints for a maximum score of 28 tender joints. Higher scores correspond to greater disease activity.|Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140|The included population includes all participants who entered the study. All included participants were part of safety population. Here, n = number of participants who were evaluable at specific time points.||tender joints||Standard Deviation|Mean
674052|NCT01655381|Secondary|Change From Day 1 in Simplified Disease Activity Index (SDAI) Scores Over Time|SDAI was calculated using SJC28, TJC28, C-reactive protein (CRP) (milligrams per liter (mg/L)), and the patient’s global assessment of disease activity and physician’s global assessment of disease activity; SDAI scores range from 0 to 86, where lower scores indicate less disease activity.|Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140|The included population includes all participants who entered the study. All included participants were part of safety population. Here, n = number of participants who were evaluable at specific time points.||units on a scale||Standard Deviation|Mean
674053|NCT01655381|Secondary|Change From Day 1 in DAS28-ESR Scores Over Time|DAS28-ESR was calculated using Swollen Joint Count Based on 28 Joints (SJC28), Tender Joint Count Based on 28 Joints (TJC28), ESR (mm/hour) and patient’s global assessment of disease activity (100-millimeter (mm) horizontal visual analog scale with 0=no disease activity to 100=maximum disease activity. DAS28-ESR scores range from 0 to 10, with higher scores corresponding to greater disease activity.|Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140|The included population includes all participants who entered the study. All included participants were part of safety population. Here, n = number of participants who were evaluable at specific time points.||units on a scale||Standard Deviation|Mean
674054|NCT01655381|Secondary|Time to RA Flare Following Remission or Drug-Free Remission|Time to RA flare was defined as period of clinical remission or drug-free remission followed by flare of DAS28-ESR (increase in DAS28-ESR from the previous available visits of >1.2, or >0.6 if current DAS28-ESR ≥3.2). In the case of several remission periods for the same participant, the largest period was used.|Up to approximately 148 weeks|The included population includes all participants who entered the study. All included participants were part of safety population.||days||Full Range|Median
674055|NCT01655381|Secondary|Percentage of Participants With at Least 1 Rheumatoid Arthritis (RA) Flare|An RA flare was defined as an increase in DAS28-ESR from the previous available visits of >1.2, or >0.6 if current DAS28-ESR ≥3.2. DAS28-ESR scores range from 0 to 10, with higher scores corresponding to greater disease activity.|Up to approximately 148 weeks|The included population includes all participants who entered the study. All included participants were part of safety population.||percentage of participants|||Number
674056|NCT01655381|Secondary|Cumulative Time of Remission Per Participant Over the Extension Study Period|Clinical remission was defined as DAS28-ESR <2.6 and/or SDAI ≤3.3 for a period of at least two consecutive assessment visits (every 12 weeks) over the extension study period. DAS28-ESR scores range from 0 to 10, with higher scores corresponding to greater disease activity. SDAI scores range from 0 to 86, where lower scores indicate less disease activity.|Up to approximately 148 weeks|The included population includes all participants who entered the study. All included participants were part of safety population.||days||Full Range|Median
674057|NCT01655381|Secondary|Percentage of Participants With at Least One Drug-Free Period|Drug-free remission period was defined as clinical remission for at least 2 consecutive assessment visits (every 12 weeks) AND without tocilizumab administration during this clinical remission period.|Up to approximately 148 weeks|The included population includes all participants who entered the study. All included participants were part of safety population.||percentage of participants|||Number
674258|NCT01652716|Secondary|Percentage of Subjects Achieving HbA1c <7% at Week 28|Percentage of subjects achieving HbA1c <7% at Week 28/Study Termination|Baseline to Week 28|Modified Intent-to-Treat: Subjects who were randomized and received at least one dose of study drug.||Percentage of subjects|||Number
674058|NCT01655381|Secondary|Percentage of Participants With at Least One Clinical Remission Period|Clinical remission: Disease Activity Score Based on 28-joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR) less than (<)2.6 and/or Simplified Disease Activity Index (SDAI) less than or equal to (≤)3.3 for a period of at least two consecutive assessment visits (every 12 weeks) over the extension study period. DAS28-ESR was calculated using Swollen Joint Count Based on 28 Joints (SJC28), Tender Joint Count Based on 28 Joints (TJC28), ESR (mm/hour) and patient’s global assessment of disease activity (100-millimeter (mm) horizontal visual analog scale with 0=no disease activity to 100=maximum disease activity. DAS28-ESR scores range from 0-10, with higher scores corresponding to greater disease activity. SDAI was calculated using SJC28, TJC28, C-reactive protein (CRP) (milligrams per liter (mg/L)), the patient’s global assessment of disease activity and physician’s global assessment of disease activity; SDAI scores range from 0-86, where lower scores indicate less disease activity.|Up to approximately 148 weeks|The included population includes all participants who entered the study. All included participants were part of safety population.||percentage of participants|||Number
674059|NCT01655381|Primary|Percentage of Participants With Any Adverse Event (AE)|An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any AE that is fatal; life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability/incapacity; congenital anomaly/birth defect in a neonate/infant or significant medical event in the Investigator’s judgment. AE of special interest (AESI) includes serious and/or medically significant infectious; myocardial infarction(MI) / acute coronary syndrome (ACS); gastrointestinal (GI) perforation; anaphylaxis / hypersensitivity reactions; demyelinating disorders; stroke; serious and/or medically significant bleeding events; serious and/or medically significant hepatic events; malignancies malignant.|Up to 160 weeks|Safety population is defined as all included participants who received having at least one tocilizumab administration.||percentage of participants|||Number
674060|NCT01655329|Other Pre-specified|Likert-Like|Following the viewing of the test radiographs, the radiologists were asked a series of questions of overall preference. On this scale, 1 indicates strong disagreement, 5 indicates strongly agree. Ten statements were used. Note that a low value for the standard image is equivalent to a high value for the modified image.|10 minutes|All 10 radiologist participants participated||units on a scale||Standard Deviation|Mean
674061|NCT01655329|Primary|Accuracy in Detecting the Tips of Tubes, Lines, and Wires.|Measurement of accuracy in determining the location of the tips of nasogastric tubes (NG) (various types of nasogastric tubes combined) and of the tips of venous catheters (various types of venous catheters combined), compared to the determination of the expert panel. Measure is the distance from the median location determined by five experts in chest radiology.|8 hours|||centimeters||Standard Error|Mean
674062|NCT01655329|Primary|Time for Completion of Tasks|Time for completion of tasks of identifying the tips of tubes, lines, and wires. Outlying values are excluded from the calculation of the mean values and standard errors. Outlying values were defined as those more than three standard deviations from the mean time.|8 hours|Each radiologist interpreted only half (158) chest radiographs. All of the radiographs were interpreted by a combination of the 10 radiologist participants.||seconds|Participants|Standard Error|Mean
674063|NCT01655043|Secondary|Coronary Blood Volume Calculation Using MRI Stress Perfusion|The investigators anticipate that CBV changes (in ml/100g of tissue) under stress reflect complementary physiologic feed back to stress perfusion scans, contrary to the hypothesis by many groups who claim that cardiac BOLD and/or rest-perfusion scans can determine without recourse to exercise or pharmacological stress.|18 months||||||
674064|NCT01655043|Primary|Quantification of Myocardial Blood Volume|The investigators anticipated that a novel MRI imaging protocol using a high relaxivity blood-pool contrast agent (gadofosveset trisodium) would be capable of quantifying coronary flow reserve based on quantification of myocardial blood volume and would be correlated with myocardial flow reserve as measured in low spatial resolution nuclear SPECT scans. Pre- and post- gadofosveset trisodium images were to be used to calculate the myocardial blood volume. Myocardial blood volume is derived from an equation of the relaxation times of hydrogen atoms in the blood and myocardium. If the agent administered did not behave as a true intravascular agent in the myocardium, quantification of myocardial intravascular blood volume (and hence a calculated coronary flow reserve) could not be calculated using the specified approach. In this case, relaxation times would be reported. Relaxation (R) times are measured in inverse seconds.|outcome measured following single MRI scan|||seconds^-1||Standard Deviation|Mean
674065|NCT01654887|Primary|Percentage of Participants Whose Pneumonia Was Missed by LUS or CXR||week 1-2|||percentage of participants||95% Confidence Interval|Number
674066|NCT01654887|Secondary|Comparison of the Length of Stay in the ED|Chart review conducted to assess overall LOS in the ED.|up to 5 hours|||minutes||Inter-Quartile Range|Median
674067|NCT01654887|Secondary|Percentage of Participants Who Had Hospital Admission.|Chart review and follow up phone call made at 1-2 weeks to assess whether or not the subject was admitted during the index ED visit or at a later healthcare visit.|weeks 1-2|||percentage of participants||95% Confidence Interval|Number
674068|NCT01654887|Secondary|Percentage of Participants With Antibiotic Use|A chart review and follow up phone call made at 1-2 weeks to assess whether or not the subject was started on antibiotics during the index Emergency Department (ED) visit or at a later healthcare visit.|weeks 1-2|||percentage of participants||95% Confidence Interval|Number
674069|NCT01654887|Secondary|Comparison of Unscheduled Healthcare Visits|Percentage of participants who had unscheduled healthcare visits after the index Emergency Department visit between those subjects who undergo CXR first and those who undergo LUS first.|week 1-2|||percentage of participants||95% Confidence Interval|Number
674070|NCT01654887|Primary|Percentage of Participants For Whom CXR Was Not Needed to Diagnose Pneumonia|The percentage of Participants For Whom CXR Was Not Needed (or received only lung US) to Diagnose Pneumonia. The primary objective of this study is to determine if it is possible for lung ultrasound (LUS) to replace chest x-ray (CXR) when evaluating patients with possible pneumonia. Specifically, an overall reduction of CXR when LUS is used first. Null hypothesis is that LUS cannot replace CXR for the diagnosis of pneumonia. Alternate hypothesis is that LUS can replace CXR for pneumonia.|up to 5 hours|||percentage of participants||95% Confidence Interval|Number
685590|NCT01499810|Secondary|Change in Office Diastolic BP||from baseline to 6 month|||mmHg||Standard Error|Mean
674071|NCT01654861|Secondary|Anti-Tumor Response|CT and PET scans will be performed at baseline and then every two months. Target and Non-Target Lesions will be identified and recorded at baseline. When subsequent scans are performed, anti-tumor responses will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST).|Every 2 months for up to 6 months.|Data were not analyzed as the study was prematurely closed.|||||
674072|NCT01654861|Primary|Adverse Events as a Measure of Safety and Tolerability|Adverse events, whether volunteered by the study subject, discovered by the investigators during questioning, or detected by physical examination, laboratory tests, or other means will be collected and recorded at each visit. Events will be recorded from the time the consent is signed until 4 weeks after the study protocol is discontinued. Subjects experiencing Grade 4 neutropenia, Grade ≥3 thrombocytopenia, or Grade 2 peripheral neuropathy who do not recover will have treatment protocol discontinued.|Weekly for up to 6 months.|||participants|Participants||Number
674073|NCT01654796|Primary|Hamilton Rating Scale for Depression – 6 Items|The total HAM-D-6 score is reported. The range of possible scores on the HAM-D-6 is from 0 to 22. Higher values indicate increased depression severity, and worse outcomes. This instrument is completed with a structured interview guide by the clinician based on his/her assessment of the patient's symptoms. This structured interview has been validated for use with time frames shorter than one week.The time frame for this scale is the past 24 hours.|Baseline and 48 hours after initiating treatment|Please note that while 85 subjects were randomized, only 84 subjects were included in the outcome analysis due to missing data.||units on a scale||Standard Deviation|Mean
674074|NCT01654666|Secondary|Serum S-100B Levels.||Baseline, on admission, and 1 and 24 hours after carotid artery stenting.|The analysed population only included participants who finished carotid artery stenting, post-treatment MRI scans and blood drawn.||pg/mL||Standard Deviation|Mean
674075|NCT01654666|Secondary|Serum Neuron Specific Enolase (NSE) Levels.||Baseline, on admission, and 1 and 24 hours after carotid artery stenting.|The analysed population only included participants who finished carotid artery stenting, post-treatment MRI scans and blood drawn.||ng/L||Standard Deviation|Mean
674076|NCT01654666|Secondary|Number of Patients With Any Side Effects of Remote Ischemic Preconditioning (RIPC) Treatment.|The side effects referred to any side effects of RIPC or sham RIPC treatment, not including the sides effect of medications and CAS.|From baseline to 6 months after treatment.|||participants|||Number
674077|NCT01654666|Secondary|Serum High-sensitive C-reactive Protein (Hs-CRP).||Baseline, on admission, and 1 and 24 hours after carotid artery stenting.|The analysed population only included participants who finished carotid artery stenting, post-treatment MRI scans and blood drawn.||mg/L||Inter-Quartile Range|Median
674078|NCT01654666|Primary|Participants Who Got New Diffusion-weighted Imaging (DWI) Lesions on Post-treatment Magnetic Resonance Imaging (MRI) Scans.||Within 48 hours after carotid artery stenting.|The analysed population only included participants who finished carotid artery stenting, post-treatment MRI scans and blood drawn.||participants|||Number
674079|NCT01654666|Primary|Number of Patients With Cerebrovascular Events, Cardiovascular Events or Death.|Cerebrovascular events included ischemic stroke, transient ischemic attack (TIA), cerebral hemorrhage and hyperperfusion syndrome. Cardiovascular events included angina and myocardial infarction.Death included any reason caused death.|Within six months after carotid artery stenting|The analysis population only included participants who fully completed the study.||participants|||Number
674080|NCT01654601|Secondary|Accumulation Rate of Clozapine in Plasma||Up tp 12hours|||ng/ml/hr||Standard Deviation|Mean
674081|NCT01654601|Secondary|Terminal Half Life of Clozapine in Plasma||Up to 12hours|||hour||Standard Deviation|Mean
674082|NCT01654601|Secondary|Time to Reach Maximum Concentration of Clozapine in Plasma||Up to 12hours|||hour||Standard Deviation|Mean
674083|NCT01654601|Primary|Maximum Concentration of Clozapine in Plasma||Up to 12hours|||ng/mL||Standard Deviation|Mean
674084|NCT01654549|Secondary|Anthropometric Measurements|Secondary outcome measure was change in anthropometric measurements (body mass index and waist circumference) from baseline to the end of study|8 weeks||||||
674085|NCT01654549|Secondary|Homeostasis Model Assessment-Insulin Resistance (HOMA-IR)|Secondary outcome measure was change in HOMA-IR from baseline to the end of study|8 weeks||||||
674086|NCT01654549|Secondary|Serum Lipid Profile|Secondary outcome measure was change in serum lipid profile (including serum triglyceride, cholesterol, low-density lipoprotein, and high-density lipoprotein concentration) from baseline to the end of study|8 weeks||||||
674087|NCT01654549|Secondary|Fasting Serum Glucose|Secondary outcome measure was change in fasting serum glucose concentration from baseline to the end of study|8 weeks||||||
674088|NCT01654549|Secondary|Serum Aspartate Aminotransferase Level|Secondary outcome measure was change in serum aspartate aminotransferase concentration from baseline to the end of study|8 weeks||||||
674089|NCT01654549|Secondary|Serum Alanine Aminotransferase Level|Secondary outcome measure was change in serum alanine aminotransferase concentration from baseline to the end of study|8 weeks||||||
674090|NCT01654549|Primary|Liver Fat Content|"Primary outcome measure was changes in the liver fat content from baseline to the end of study (6 weeks post-treatment).
The percent of liver fat was calculated as below:
“Liver fat content (%) = 10 (-0.805 + 0.282 * metabolic syndrome (yes = 1 / no = 0) + 0.078 * type 2 diabetes (yes =2 / no =0) + 0.525 * log fasting serum insulin (mU/L) + 0.521 * log fasting serum AST (U/L) – 0.454 * log (AST/ALT)”"|8 weeks (6 weeks post-treatment)|||percentage of liver fat content||Standard Deviation|Mean
674091|NCT01654536|Secondary|Percentage of Subjects With Change From Baseline in Best Corrected Visual Acuity.||0-6 months|Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.||percentage of participants|||Number
674092|NCT01654536|Secondary|Number of Subjects With Change From Baseline in Best Corrected Visual Acuity.||0-6 months|Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.||participants|||Number
685591|NCT01499810|Secondary|Change in Office Systolic BP||from baseline to 6 month|||mmHg||Standard Deviation|Mean
674093|NCT01654536|Secondary|Percentage of Subjects With Increase ≥ 7 mm Hg From Baseline in Intraocular Pressure, or a Change to > 21 mm Hg, in Either Eye||0-6 months|Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.||percentage of partcipants|||Number
674094|NCT01654536|Secondary|Number of Subjects With Increase ≥ 7 mm Hg From Baseline in Intraocular Pressure, or a Change to > 21 mm Hg, in Either Eye||0-6 months|Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.||participants|||Number
674095|NCT01654536|Secondary|Percentage of Subjects With Development of or Worsening in Lens Opacities.||0-6 months|||percentage of participants|||Number
674096|NCT01654536|Secondary|Number of Subjects With Development of or Worsening in Lens Opacities.||0-6 months|||participants|||Number
674097|NCT01654536|Secondary|The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.||0-6 months|Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.||percentage of participants|||Number
674098|NCT01654536|Secondary|The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.||0-6 months|Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.||participants|||Number
674099|NCT01654536|Secondary|The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs).||0-6 months|Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.||percentage of participants|||Number
674100|NCT01654536|Primary|The Percentage of Subjects Experiencing Nasal Mucosal Disorders, Septum Disorders, or Nasal Septum Perforations as Treatment Emergent Adverse Events (AEs; TEAE)||0-6 months|Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.||percentage of participants|||Number
674101|NCT01654536|Secondary|The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs).||0-6 months|Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.||participants|||Number
674102|NCT01654536|Secondary|The Percentage of Subjects Experiencing Treatment Emergent AEs.||0-6 months|Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.||percentage of participants|||Number
674103|NCT01654536|Secondary|The Number of Subjects Experiencing Treatment Emergent AEs.||0-6 months|Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.||participants|||Number
674104|NCT01654536|Secondary|The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs.||0-6 months|Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.||percentage of participants|||Number
674105|NCT01654536|Secondary|The Number of Subjects Experiencing Treatment Emergent Nasal AEs.||0-6 months|Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.||participants|||Number
674106|NCT01654536|Primary|The Number of Subjects Experiencing Nasal Mucosal Disorders, Septum Disorders, or Nasal Septum Perforations as Treatment Emergent Adverse Events (AEs; TEAE)||0-6 months|Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.||participants|||Number
674107|NCT01654523|Primary|Mean Change in Massachusetts General Hospital Hairpulling Scale Baseline to Post-treatment|Measures severity of trichotillomania. Total score ranges from 0 (none) to 28 (severe). Mean change is determined by score at baseline minus score after treatment.|Baseline to post treatment; typically over 9 weeks|||Units on a scale||Standard Deviation|Mean
674108|NCT01654302|Primary|Index Knee Pain Scores on a Numeric Rating Scale (NRS)|Subject rated index knee pain 5 minutes after stopped experimental exercise (with intervention). Index knee pain was reported using the Numeric Rating Scale, a scale from 0 to 10 where 0 = no pain and 10 = the worst pain possible.|5 minutes after stopped exercise, performed 1 hour after intervention (patch application)|Of the 40 subjects 2 were lost to follow-up, one from each group, making a total of 38 participants included in the analysis. Unfortunately, NRS data at 5 minutes post-exercise is missing for 2 subjects in the Synera treatment group and 1 subject in the Placebo group due to technical errors. The data was captured but we were unable to retrieve it.||units on a scale||Standard Deviation|Mean
674109|NCT01654276|Primary|Urine pH||6 months|||pH||Standard Deviation|Mean
674124|NCT01654263|Secondary|Immunogenicity: Serotype-specific OPA Titer to 12 Vaccine Serotypes at Days 0 and 180 Post Vaccination.|Blood was collected from all participants at Days 0 and 180 after receipt of vaccination. The geometric mean for each group was then assessed by serotype-specific opsonophagocytic antibody (OPA).|Day 0 and Day 180 post vaccination|All participants who received vaccination and had immunology samples obtained within the protocol-defined windows for Days 0, 28, and 180 are included. Three additional subjects were excluded for not meeting eligibility criteria or receipt of a non-study vaccine. Data were analyzed regardless of age strata as pre-specified in the study protocol.||Titer||95% Confidence Interval|Geometric Mean
674125|NCT01654263|Primary|Geometric Mean Titers of Serotype-specific Opsonophagocytic Antibody (OPA) to 12 Vaccine Serotypes at Days 0 and 28 Post Vaccination.|Blood was collected from all participants at Day 0 and Day 28 after receipt of vaccination. The geometric mean for each group was then assessed by serotype-specific opsonophagocytic antibody (OPA).|Day 0 and Day 28 post vaccination|All participants who received vaccination and had immunology samples obtained within the protocol-defined windows for Days 0, 28, and 180 are included. Three additional subjects were excluded for not meeting eligibility criteria or receipt of a non-study vaccine. Data were analyzed regardless of age strata as pre-specified in the study protocol.||Titer||95% Confidence Interval|Geometric Mean
674126|NCT01654263|Primary|Number of Participants Reporting Vaccine-related Serious Adverse Events.|"Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation thereof; was a congenital anomaly/birth defect; or may have jeopardized the participant, or required intervention to prevent one of the outcomes. Association with PCV13 was determined by the investigator and defined as Related, meaning there was a known temporal relationship, or the event was known to occur in association with study product or with a product in a similar class of study products and no alternate etiology was identified."|Up to Day 180 post vaccination|All participants who received vaccination are included. Data were analyzed regardless of age strata as pre-specified in the study protocol.||participants|||Number
674127|NCT01654263|Primary|Number of Participants Reporting Unsolicited Vaccine-related Adverse Events.|"Association with PCV13 was determined by the investigator and defined as Related, meaning there was a known temporal relationship, or the event was known to occur in association with study product or with a product in a similar class of study products and no alternate etiology was identified."|Up to Day 28 post vaccination|All participants who received vaccination are included. Data were analyzed regardless of age strata as pre-specified in the study protocol.||participants|||Number
674128|NCT01654263|Primary|Number of Participants Reporting Solicited Local and Systemic Adverse Events|Participants maintained a memory aid to record daily the occurrence of local injection site reactions and systemic reactions for 8 days after vaccination based on their interference with daily activities for subjective symptoms or quantitative measurement of the reaction. All participants reporting events of any severity (mild, moderate, or severe) are counted. For measured reactions, participants are included if the reaction is >0mm.|Days 0 to Day 7 post vaccination|All participants who received vaccination are included. Data were analyzed regardless of age strata as pre-specified in the study protocol.||participants|||Number
674129|NCT01654250|Other Pre-specified|Conners Parent Rating Scale (CPRS) Scores|CPRS was used to measure features associated with ADHD and was used to compare scores during the dose optimization period i.e. 1-6 weeks. The assessment was performed by parent or guardian. CPRS consisted of 27 questions graded on a scale from 0 (not true at all) to 3 (very much true). Raw scores were converted to t-scores and t-scores have a mean of 50 ± 10 where higher scores are indicative of greater problems. The participant received normalized t-scores on the following scales: oppositional, cognitive problems/inattention, hyperactivity, anxious-shy, perfectionism, social problems, psychosomatic, ADHD index, restless-impulse, emotional liability, conner's global index, inattentive, hyperactive-impulsive and diagnostic and statistical manual of mental disorders IV (DSM-IV). This outcome measure was analyzed during open label phase in entire study population prior to randomization into two treatment groups.|Baseline, Day 8, 15, 22, 29, 36, 43|ITT population included all randomized participants who received at least 1 dose of double-blind study medication (either NWP09 or matching placebo) and had at least 1 post-baseline assessment of the primary efficacy variable.||Units on a scale||Standard Deviation|Mean
674130|NCT01654250|Other Pre-specified|Clinical Global Impression-Improvement (CGI-I)|The CGI-I measured the participant’s disease improvement relative to baseline as followed: 1= very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6= much worse, and 7=very much worse. This outcome measure was analyzed during open label phase in entire study population prior to randomization into two treatment groups.|Day 8, 15, 22, 29, 36, 43|ITT population included all randomized participants who received at least 1 dose of double-blind study medication (either NWP09 or matching placebo) and had at least 1 post-baseline assessment of the primary efficacy variable.||Units on a scale||Standard Deviation|Mean
674131|NCT01654250|Other Pre-specified|Clinical Global Impression of Severity (CGI-S)|CGI-S scale was used to measure features associated with ADHD. The assessment was performed by the investigator of the study research team. The CGI-S classified the participant’s current disease status as: 1 = normal, not at all ill, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, and 7 = among the most extremely ill participants. This outcome measure was analyzed during open label phase in entire study population prior to randomization into two treatment groups.|Baseline, Day 8, 15, 22, 29, 36, 43|ITT population included all randomized participants who received at least 1 dose of double-blind study medication (either NWP09 or matching placebo) and had at least 1 post-baseline assessment of the primary efficacy variable.||Units on a scale||Standard Deviation|Mean
674132|NCT01654250|Secondary|Permanent Product Measure of Performance (PERMP) Scores at Hour 0.75, 2, 4, 8, 10, 12 and 13 Post-Dose|The PERMP score measured the manifestations of attention deficit hyperactivity disorder. The PERMP is a 10-minute written test, on 80 math problems, performed as seatwork in the classroom. At the end of the 10- minute math test , the PERMP score of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session was used to measure participant’s performance. The total score range from 0-160 with higher scores indicating better performance.|0.75, 2, 4, 8, 10, 12 and 13 post-dose|ITT population included all randomized participants who received at least 1 dose of double-blind study medication (either NWP09 or matching placebo) and had at least 1 post-baseline assessment of the primary efficacy variable.||Units on a scale||Standard Deviation|Mean
674133|NCT01654250|Secondary|Swanson, Kotin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP) SKAMP Attention and Deportment Subscale Scores at Hour 0.75, 2, 4, 8, 10, 12 and 13 Post-Dose|SKAMP scale measured the manifestations of ADHD using an independent observer rating of the participant’s impairment in classroom observed behaviors. The SKAMP subscales were obtained by summing the individual items as follows: Attention (items 1-4) and Deportment (items 5-8), where each item was rated on a 7-point scale (0=normal to 6=maximal impairment). SKAMP attention subscale was reported which evaluates concentration in the classroom and comprises of 4 items, with a total possible score for of 0 to 24; higher score indicates worst impairment. SKAMP deportment subscale was reported which assesses behavior in the classroom and comprises of 4 items, with a total possible score for each sub-scale of 0 to 24; higher score indicates worst impairment.|0.75, 2, 4, 8, 10, 12, 13 hours post-dose|ITT population included all randomized participants who received at least 1 dose of double-blind study medication (either NWP09 or matching placebo) and had at least 1 post-baseline assessment of the primary efficacy variable.||Units on a scale||Standard Deviation|Mean
674134|NCT01654250|Secondary|Onset and Duration of Clinical Effect|Onset and duration of clinical effect was determined using SKAMP combined rating scale at each post-dose time point. Onset of effect was defined as first assessment time showing statistical significance (i.e. p was less than or equal to [=<] 0.05) between NWP09 and placebo and duration of effect was defined as the as last consecutive time-point at which difference was statistically significant between NWP09 and placebo. SKAMP scale measured the manifestations of ADHD using an independent observer rating of the participant’s impairment in classroom observed behaviors. SKAMP combined score was comprised of 13 items [subscales: attention (1-4 items), deportment (5-8 items), quality of work (9-11 items) and compliance (12-13 items)]. SKAMP combined score was obtained by summing up each item score where each item was rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for total possible combined score of 0 to 78; where higher score signified worst impairment.|0.75, 2, 4, 8, 10, 12, 13 hours post-dose|ITT population included all randomized participants who received at least 1 dose of double-blind study medication (either NWP09 or matching placebo) and had at least 1 post-baseline assessment of the primary efficacy variable.||Units on a scale||Standard Deviation|Mean
674135|NCT01654250|Primary|Swanson, Kotin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP)-Combined Scores-Average of All Post-Dose Time-Points|The SKAMP scale measured the manifestations of attention deficit hyperactivity disorder (ADHD) using an independent observer rating of the participant’s impairment in classroom observed behaviors. SKAMP combined score comprised of 13 items (including subscales: attention with items 1-4, deportment with items 5-8, quality of work with items 9-11 and compliance with items 12-13). The SKAMP composite score was obtained by summing up each item score where each item was rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for a total possible combined score of 0 to 78; where higher score signified worst impairment. Average of all post dose SKAMP-combined scores measured at 0.75, 2, 4, 8, 10, 12 and 13 hours post-dose was calculated.|0.75 up to 13 hours post-dose|ITT population included all randomized participants who received at least 1 dose of double-blind study medication (either NWP09 or matching placebo) and had at least 1 post-baseline assessment of the primary efficacy variable.||units on a scale||Standard Error|Least Squares Mean
674136|NCT01654224|Primary|Non-inferiority of High-dose Inactivated Influenza Vaccine(HDIV) Versus Standard Dose Inactivated Influenza Vaccine(SDIV) Among Residents of Long Term Care(LTC) Settings|The primary objective of this study is to determine the noninferiority of high- dose inactivated influenza vaccine (HDIV) versus standard dose inactivated influenza vaccine(SDIV)among residents of long term care(LTC)settings.Non-inferiority will be determined by comparing baseline and one month post vaccination HAI and MN titers using non-inferiority analysis.|Day 0|||titers||95% Confidence Interval|Geometric Mean
674137|NCT01654224|Secondary|Non-inferiority and Immunoprotection Persistence at 6 Months|Compare the immunogenicity via HAI and MN titers for HDIV and SDIV at 6 months in frail LTC residents|6 months|The above numbers reflect the participants with data available at 6 months. Eleven subjects (five in the high dose and 6 in the standard dose groups) died of non-related causes. Some of the samples were insufficient or unable to be collected.||Titers||90% Confidence Interval|Geometric Mean
674138|NCT01654224|Primary|Non-inferiority of High-dose Inactivated Influenza Vaccine(HDIV) Versus Standard Dose Inactivated Influenza Vaccine(SDIV) Among Residents of Long Term Care(LTC) Settings|The primary objective of this study is to determine the noninferiority of high- dose inactivated influenza vaccine (HDIV) versus standard dose inactivated influenza vaccine(SDIV)among residents of long term care(LTC)settings.Non-inferiority will be determined by comparing baseline and one month post vaccination HAI and MN titers using non-inferiority analysis.|30 days|||titers||95% Confidence Interval|Geometric Mean
674139|NCT01654107|Primary|7-day Point Prevalence Abstinence|3-months after the Quit Date|3-months|||participants|||Number
674140|NCT01653964|Primary|Compare the Diagnostic Accuracy of 8 mCi Molecular Breast Imaging (MBI) With 4 mCi MBI.||At time of study (within 2 days after exam) and when enrollment has been reached (approximately 24 months)|Of 82 patients recruited to the study (prior to breast biopsy), 34 had a histologically-proven diagnosis of breast cancer.||cancers detected|||Number
674141|NCT01653782|Secondary|Cost Effectiveness|Assessments of direct and indirect cost. Further, assessments of performance is used to calculate production losses.|6 months, 12 months||||||
674142|NCT01653782|Primary|Number of Days on Sick Leave|Sick leave using self-reported data on number of days on sick leave|12 MONTHS|by a power calculation based on estimates of change in the primary outcome variables from earlier studies||Days||Standard Deviation|Mean
674143|NCT01653743|Secondary|Percentage of Participants With Clinical Pregnancy|Percentage of subjects with clinical pregnancy was assessed. Clinical pregnancy was defined as the presence of at least a fetal sac on TVUS.|Day 35 to 42 post hCG treatment|The Mod ITT population was defined as all subjects randomized to IMP (MSJ-0011 or u-hCG) and who completed the primary efficacy assessment.||percentage of subjects||95% Confidence Interval|Number
674144|NCT01653743|Secondary|Percentage of Participants With Biochemical Pregnancy|Percentage of subjects with biochemical pregnancy was assessed. Biochemical pregnancy was defined as any miscarriage without any evidence of a fetal sac on TVUS on the Day 35 to 42 post hCG treatment, but with a positive serum β-hCG pregnancy test on Day 15 to 20 post hCG treatment (Beta-hCG level greater than [>] 10 IU/Liter)|Day 35 to 42 post hCG treatment|The Mod ITT population was defined as all subjects randomized to IMP (MSJ-0011 or u-hCG) and who completed the primary efficacy assessment.||percentage of subjects||95% Confidence Interval|Number
674146|NCT01653743|Secondary|Percentage of Subjects With Ovulation Mid-Luteal Serum Progesterone (P4) Level of Greater Than or Equal (>=) 9.4 Nanogram Per Milliliter (ng/mL) or Clinical Pregnancy|Ovulation was defined as mid-luteal serum progesterone level of >= 9.4 ng/mL or clinical pregnancy. Clinical pregnancy was defined as the presence of at least a fetal sac on TVUS.|Mid-luteal phase progesterone assessed (Day 5 to 10) or clinical pregnancy (Day 35 to 42) post hCG treatment|The Mod ITT population was defined as all subjects randomized to IMP (MSJ-0011 or u-hCG) and who completed the primary efficacy assessment.||percentage of subjects||95% Confidence Interval|Number
674147|NCT01653743|Primary|Percentage of Subjects With Ovulation Mid-luteal Serum Progesterone (P4) Level of Greater Than or Equal (>=) 5 Nanogram Per Milliliter (ng/mL) or Clinical Pregnancy|Ovulation was defined as mid-luteal serum progesterone level of >= 5 ng/mL or clinical pregnancy. Clinical pregnancy was defined as the presence of at least a fetal sac on transvaginal ultrasound (TVUS).|Mid-luteal phase progesterone assessed (Day 5 to 10) or clinical pregnancy (Day 35 to 42) post hCG treatment|The modified intent to treat (Mod ITT) population was defined as all subjects randomized to IMP (MSJ-0011 or u-hCG) and who completed the primary efficacy assessment.||percentage of subjects||95% Confidence Interval|Number
674148|NCT01653509|Secondary|Participant Assessment of Symptom Intensity at Day 10|Cold sore symptoms (pain, burning, itching) assessment was performed on a 5-point scale: 1=Never Bothered 2=Rarely Bothered 3=Bothered Some of the Time 4=Bothered Often 5=Bothered All the Time.|Day 10|"ITT population: all randomized participants who had a patch applied to their cold sore and have at least one post-baseline efficacy measurement. There were differences in the number of participants analyzed for each end point, as represented by n."||Units on a scale||Standard Deviation|Mean
674149|NCT01653509|Secondary|Participant Assessment of Symptom Intensity at Day 5|Cold sore symptoms (pain, burning, itching) assessment was evaluated on a 5-point scale: 1=Never Bothered, 2=Rarely Bothered, 3=Bothered Some of the Time, 4=Bothered Often, 5=Bothered All the Time.|Day 5|"ITT population: all randomized participants who had a patch applied to their cold sore and have at least one post-baseline efficacy measurement. There were differences in number of participants analyzed for each end point as represented by n."||Units on a scale||Standard Deviation|Mean
674150|NCT01653509|Secondary|Participant Assessment of Patch Comfort and Noticeability at Day 10|"Participants reported experience of the patch aesthetics and cold sore noticeability on the cold sore using a 5-point scale ( 1=Strongly Disagree 2=Rather Disagree 3=Neither Agree nor Disagree 4=Mostly Agree 5=Completely Agree) on 9 questions asked to them:
Today my sore felt completely protected
Today my cold sores interfered with facial movements such as smiling, eating or drinking
Today my cold sores interfered with my interaction with other people
Today the patch disguised my cold sores
Today I was bothered by the appearance of my cold sores
Today my patch was easy to apply
Today the patch covering my cold sores was bothersome
Today the patches stayed in place on my cold sores until I removed them
Today the patches were easy to remove from my lip or skin"|Day 10|"ITT population: all randomized participants who had a patch applied to their cold sore and have at least one post-baseline efficacy measurement. There were differences in number of participants analyzed for each end point as represented by n."||Units on a scale||Standard Deviation|Mean
674151|NCT01653509|Secondary|Participant Assessment of Patch Comfort and Noticeability at Day 5|"Participants reported experience of the patch aesthetics and cold sore noticeability on the cold sore using a 5-point scale ( 1=Strongly Disagree 2=Rather Disagree 3=Neither Agree nor Disagree 4=Mostly Agree 5=Completely Agree) on 9 questions asked to them:
Today my sore felt completely protected
Today my cold sores interfered with facial movements such as smiling, eating or drinking
Today my cold sores interfered with my interaction with other people
Today the patch disguised my cold sores
Today I was bothered by the appearance of my cold sores
Today my patch was easy to apply
Today the patch covering my cold sores was bothersome
Today the patches stayed in place on my cold sores until I removed them
Today the patches were easy to remove from my lip or skin"|Day 5|"ITT population: all randomized participants who had a patch applied to their cold sore and had at least one post-baseline efficacy measurement. There were difference in number of participants analyzed for each end point as represented by n."||Units on a scale||Standard Deviation|Mean
674152|NCT01653509|Primary|Mean Change From Baseline in Color Intensity of Lesions|The redness of the cold sores to be measured and quantified using sophisticated, standardized and reproducible color photography. Parameter represents distance between test and control values according to a* axis and b* axis colour intensity values. The values on the scale ranged from -100 (green, lowest intensity) to +100 (red, highest intensity).|Baseline to Day 10|ITT population: all randomized participants who had a patch applied to their cold sore and have at least one post-baseline efficacy measurement.||Units on a scale||Standard Error|Least Squares Mean
674153|NCT01653509|Primary|Mean Change From Baseline in Temperature|Lesion thermographic parameters for TEV and MEV were analysed.|Baseline to Day 10|ITT population: all randomized participants who had a patch applied to their cold sore and have at least one post-baseline efficacy measurement.||Degree celsius||Standard Error|Least Squares Mean
674154|NCT01653509|Primary|Mean Change From Baseline in Blood Flow|"Measurement of blood flow was performed using Field Laser Perfusion Imaging (FLPI) technique.
Total episode value (TEV) was calculated as the summation of (test region response minus control region response) across all days. Maximum episode value (MEV) was calculated as the maximum of (test region response minus control region response) across all days."|Baseline to Day 10|Intent to Treat (ITT) population: all randomized participants who had a patch applied to their cold sore and have at least one post-baseline efficacy measurement.||Perfusion Units||Standard Error|Least Squares Mean
674155|NCT01653418|Secondary|Time to Platelet Engraftment After V-BEAM.|Time to platelet engraftment is defined as the duration between Day 0 to the first day of platelet count sustained at > 20x109/L without transfusion. The median time to neutrophil and platelet engraftment will be reported.|Day +100|Two participants without evaluable responses due to early mortality were not included in this analysis.||days||Full Range|Median
674156|NCT01653418|Secondary|Treatment Related Mortality (TRM) of V-BEAM||Day +100|||participants|||Number
674157|NCT01653418|Secondary|Number of Participants With Overall Survival (OS)|OS is defined as the duration from the time of transplant to death or last follow-up.|Median follow-up of 6 months (range: 6-12 months)|||participants|||Number
674158|NCT01653418|Secondary|Time to Neutrophil Engraftment After V-BEAM.|Time to neutrophil engraftment is defined as duration between Day 0 to the first day of ANC > 0.5x109/L post transplant when it is sustained for more than three consecutive days.|Day +100|Two participants without evaluable responses due to early mortality were not included in this analysis.||days||Full Range|Median
674159|NCT01653418|Secondary|Toxicity of V-BEAM|"Graded per the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Patients are evaluated from first receiving study treatment until a 30-day follow-up after the conclusion of treatment for adverse events not resulting in death. Adverse events resulting in death will be evaluated through Day +100.
This outcomes measures the common toxicities observed. Please refer to the Serious Adverse Event and Other Adverse Event sections of the results for further details."|30 days after end of treatment / Day +100|||participants|||Number
674160|NCT01653418|Secondary|Very Good Partial Response Rate (VGPR+nCR+sCR+CR)|Response will be assessed per the International Myeloma Working Group (IMWG) Response Criteria.|Day +100|Two participants without evaluable responses due to early mortality were not included in this analysis.||participants|||Number
674161|NCT01653418|Secondary|Overall Response Rate (ORR)|"ORR includes Partial Response (PR) + Very Good Partial Response (VGPR) + Complete Response (CR)
Response will be assessed per the International Myeloma Working Group (IMWG) Response Criteria."|3 months following Day +100 visit|Two participants without evaluable responses due to early mortality were not included in this analysis.||participants|||Number
674162|NCT01653418|Secondary|Number of Participants With Progression-free Survival (PFS)|"PFS is defined as the duration from transplant to time of first progression, death, relapse after CR, or the date the patient was last known to be in remission.
Response will be assessed per the International Myeloma Working Group (IMWG) Response Criteria."|Median follow-up of 6 months (range: 6.0-12.0 months)|Two participants without evaluable responses due to early mortality were not included in this analysis.||participants|||Number
674163|NCT01653418|Primary|Complete Response Rate (Complete Response + Stringent Complete Response)|Defined by the International Myeloma Working Group (IMWG) criteria|Day +100|Two participants without evaluable responses due to early mortality were not included in this analysis.||participants|||Number
674164|NCT01653262|Secondary|Generalized Seizure Days Over the Treatment Period for Subjects With Idiopathic Generalized Epilepsy|"Generalized seizure days are standardized to a 28-day duration and changes in generalized seizure days are measured relative to the reported seizure counts for the 4 weeks prior to Visit 2 (Week 0).
Generalized seizures (Type II) include the following seizure types:
Absence (IIA1)
Atypical absence (IIA2)
Myoclonic (IIB)
Clonic (IIC)
Tonic (IID)
Tonic-clonic (IIE)
Atonic (IIF)
A specific effect of BRV on the occurrence of generalized seizures was not assessed."|From 4 weeks prior to Visit 2 (Week 0) to the end of the Treatment Period (Visit 6, Week 12) or Early Discontinuation Visit|This variable was not analyzed and no results are available.|||||
674165|NCT01653262|Secondary|Partial Onset Seizure (POS) Frequency Over the Treatment Period for Subjects With Focal Epilepsy|"The POS frequency is standardized to a 28-day duration and changes in POS frequency are measured relative to the reported seizure counts for the 4 weeks prior to Visit 2 (Week 0).
Partial seizures can be classified into one of the following three groups:
Simple partial seizures (IA)
Complex partial seizures (IB)
Partial seizures evolving to secondarily generalized seizures (IC)"|From 4 weeks prior to Visit 2 (Week 0) to the end of the Treatment Period (Visit 6, Week 12) or Early Discontinuation Visit|The Efficacy Analysis Set (EAS) consisted of all subjects who received at least 1 dose of Brivaracetam and had at least 1 post-Baseline day of seizure daily record card (subject diary card).||partial onset seizures||Inter-Quartile Range|Median
674166|NCT01653262|Secondary|Occurrence of Serious Adverse Events During the Study Period|A serious adverse event is any untoward medical occurrences in a subject administered study treatment, whether or not the event is related to treatment, with at least one of the follow outcomes: death, life-threatening, initial inpatient hospitalization or prolongation of hospitalization, significant or persistent disability/incapacity, congenital anomaly/birth defect, or an important medical event that may jeopardize the subject and require a medical/surgical intervention.|From Study Entry (Visit1, Week -1) to the end of the Treatment Period (Visit 6, Week 12) or Early Discontinuation Visit|The Safety Set (SS) consisted of all subjects who received at least 1 dose of Brivaracetam.||events|||Number
674167|NCT01653262|Secondary|Withdrawal Due to an Adverse Event (AE) During the Study Period|An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.|From Study Entry (Visit1, Week -1) to the end of the Treatment Period (Visit 6, Week 12) or Early Discontinuation Visit|The Safety Set (SS) consisted of all subjects who received at least 1 dose of Brivaracetam.||subjects|||Number
674168|NCT01653262|Secondary|Incidence of Treatment Emergent Adverse Events During the Study Period|An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. A treatment emergent AE is any event that emerges during treatment having been absent pre-treatment, or worsens relative to the pre-treatment state.|From Study Entry (Visit1, Week -1) to the end of the Treatment Period (Visit 6, Week 12) or Early Discontinuation Visit|The Safety Set (SS) consisted of all subjects who received at least 1 dose of Brivaracetam.||events|||Number
674169|NCT01653262|Secondary|Number of Subjects Who Are Free From Nonpsychotic Behavioral Side Effects Over the Entire Treatment Period|Nonpsychotic behavioral side effects (NBSE) include (but are not limited to) such symptoms as aggression, agitation, anger, anxiety, apathy, depersonalization, depression, emotional lability, hostility, irritability, etc.|From Visit 2 (Week 0) to Visit 6 (Week 12)|The Full Analysis Set (FAS) consisted of all subjects who received at least 1 dose of Brivaracetam and had at least 1 post-Baseline evaluation of behavioral side effects.||subjects|||Number
674170|NCT01653262|Secondary|Number of Subjects Who Have a Complete Abatement of Nonpsychotic Behavioral Side Effects for the Last Assessment During the Treatment Period, Based on the Investigator's Overall Assessment|Nonpsychotic behavioral side effects include (but are not limited to) such symptoms as aggression, agitation, anger, anxiety, apathy, depersonalization, depression, emotional lability, hostility, irritability, etc.|From Baseline (maximum of 12 weeks prior to Study Entry at Week -1) to the end of the Treatment Period (Visit 6, Week 12) or Early Discontinuation Visit|The Full Analysis Set (FAS) consisted of all subjects who received at least 1 dose of Brivaracetam and had at least 1 post-Baseline evaluation of behavioral side effects.||subjects|||Number
674206|NCT01653158|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Docetaxel in Cycle 1||30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion|Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.||hr||Standard Deviation|Mean
674171|NCT01653262|Secondary|Change From Study Entry in Nonpsychotic Behavioral Side Effects to the End of the Treatment Period/Early Discontinuation Visit, Measured by Means of the Investigator Global Evaluation of Nonpsychotic Behavioral Side Effects (I-GEBSE) Scale|"There are seven levels for the I-GEBSE:
Marked improvement
Moderate improvement
Slight improvement
No change
Slight worsening
Moderate worsening
Marked worsening"|From Study Entry (Visit1, Week -1) to the end of the Treatment Period (Visit 6, Week 12) or Early Discontinuation Visit|The Full Analysis Set (FAS) consisted of all subjects who received at least 1 dose of Brivaracetam and had at least 1 post-Baseline evaluation of behavioral side effects.||subjects|||Number
674172|NCT01653262|Secondary|Shift in the Maximum Intensity From Baseline to the End of the Treatment Period for Side Effects Primarily Associated With Discontinuation of Levetiracetam (LEV) as Determined by the Investigator|Nonpsychotic behavioral side effects include (but are not limited to) such symptoms as aggression, agitation, anger, anxiety, apathy, depersonalization, depression, emotional lability, hostility, irritability, etc.|From Baseline (maximum of 12 weeks prior to Study Entry at Week -1) to the end of the Treatment Period (Visit 6, Week 12) or Early Discontinuation Visit|The Full Analysis Set (FAS) consisted of all subjects who received at least 1 dose of Brivaracetam and had at least 1 post-Baseline evaluation of behavioral side effects.||subjects|||Number
674173|NCT01653262|Primary|Percentage of Subjects Who Achieved a Clinically Meaningful Reduction of Nonpsychotic Behavioral Side Effects Based on the Investigator's Overall Assessment From Study Entry to the End of the Treatment Period|"Nonpsychotic behavioral side effects include (but are not limited to) such symptoms as aggression, agitation, anger, anxiety, apathy, depersonalization, depression, emotional lability, hostility, irritability, etc.
The Investigator completed the assessment by answering the following:
“Has there been a clinically meaningful reduction of nonpsychotic behavioral side effects since the start of BRV?”
- Yes/No"|From Study Entry (Visit1, Week -1) to the end of the Treatment Period (Visit 6, Week 12) or Early Discontinuation Visit|The Full Analysis Set (FAS) consisted of all subjects who received at least 1 dose of Brivaracetam and had at least 1 post-Baseline evaluation of behavioral side effects.||percentage of subjects|||Number
674174|NCT01653158|Secondary|Time of Last Quantifiable Time Point (Tlast) of CP-751,871 in Cycle 1 and Cycle 4|Blood samples were collected at timepoints prespecified in the study protocol. Tlast of CP-751,871 was the last time point when blood sample collected was quantifiable for CP-751,871.|Cycle 1 and 4: prior to CP-751,871 infusion, at 1 hour post CP-751,871 infusion, and at 1, 3, 7 days post end of docetaxel infusion|This OM was not reported due to registration error. This parameter was not planned or analyzed for this study.|||||
674175|NCT01653158|Secondary|Observed Concentration of CP-751,871 at Day 22 (Cday22) of Cycle 1 and 4|Cday22 is the measured CP-751,871 plasma concentration in blood sample collected at Day 22.|Cycle 1: 30 minutes prior to the Cycle 2 CP-751,871 infusion (this is Day 22 for Cycle 1); Cycle 4: 30 minutes prior to the Cycle 5 CP-751,871 infusion (this is Day 22 for Cycle 4)|All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort.||mg/L||Standard Deviation|Mean
674176|NCT01653158|Other Pre-specified|Dose Normalized Area Under the Curve From Time Zero (Day 1) to Day 22 (AUC(0-d22)(dn)) of CP-751,871 in Cycle 4|Area Under the Curve From Time Zero (Day 1) to Day 22 (AUC(0-d22)) divided by total dose|30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)|This OM was not reported due to registration error. This parameter was not planned or analyzed for this study.|||||
674177|NCT01653158|Other Pre-specified|Dose Normalized Area Under the Curve From Time Zero (Day 1) to Day 22 (AUC(0-d22)(dn)) of CP-751,871 in Cycle 1|Area Under the Curve From Time Zero (Day 1) to Day 22 (AUC(0-d22)) divided by total dose|30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)|This OM was not reported due to registration error. This parameter was not planned or analyzed for this study.|||||
674178|NCT01653158|Secondary|Observed Accumulation Ratio (Rac) of CP-751,871|AUCtao of Cycle 4 divided by AUC(0-d22) of Cycle 1|30 minutes prior to CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of CP-751,871 infusion; and 30 minutes prior to the next cycle CP-751,871 infusion (Day 22) in Cycle 1 and Cycle 4|All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort||Ratio||Standard Deviation|Mean
674179|NCT01653158|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of CP-751,871 in Cycle 4|Area under the plasma concentration versus time curve (AUC) from time zero to tau, the dosing interval, where tao is the actual time of the predose sample for the next cycle.|30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)|All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort||mg*hr/L||Standard Deviation|Mean
674180|NCT01653158|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of CP-751,871 in Cycle 1|Area under the plasma concentration versus time curve (AUC) from time zero to tau, the dosing interval, where tao is the actual time of the predose sample for the next cycle.|30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)|This OM was not reported because it is the same as Area Under the Curve From Time Zero (Day 1) to Day 22 (AUC(0-d22)) in Cycle 1 (OM 23), for both represented the planned 21-day dosing interval.|||||
674181|NCT01653158|Secondary|Volume of Distribution (Vz) of CP-751,871 in Cycle 4|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.|30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)|This OM was not reported due to insufficient data: the parameter was estimable in only 3 of 25 subjects.|||||
674280|NCT01652690|Primary|Number of Participants Receiving an Individual Prescription and Injection of Denosumab From the Initial Prescribing Physician Office by Each Individual Injection||Baseline (day 1), and at Months 6, 12, 18 and 24 (corresponding to the first, second, third and fourth post-baseline injections respectively)|Full analysis set; n = the number of participants who received the corresponding injection||participants|||Number
674182|NCT01653158|Secondary|Apparent Volume of Distribution (Vz/F) of CP-751,871 in Cycle 4|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)|This OM was not reported due to registration error: apparent volume of distribution (Vz/F) is for oral dose. Volume of Distribution (Vz) of CP-751,871 after intravenous dosing in Cycle 4 (OM 38) was the correct outcome measure to be registered.|||||
674183|NCT01653158|Secondary|Volume of Distribution (Vz) of CP-751,871 in Cycle 1|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.|30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)|All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort||mL/kg||Standard Deviation|Mean
674184|NCT01653158|Secondary|Apparent Volume of Distribution (Vz/F) of CP-751,871 in Cycle 1|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)|This OM was not reported due to registration error: apparent volume of distribution (Vz/F) is for oral dose. Volume of Distribution (Vz) of CP-751,871 after intravenous dosing in Cycle 1 (OM 36) was the correct outcome measure to be registered.|||||
674185|NCT01653158|Secondary|Volume of Distribution at Steady State (Vss) of CP-751,871 in Cycle 4|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.|30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)|This OM was not reported due to insufficient data: the parameter was estimable in only 3 of 25 subjects.|||||
674186|NCT01653158|Secondary|Volume of Distribution at Steady State (Vss) of CP-751,871 in Cycle 1|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.|30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)|All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort||mL/kg||Standard Deviation|Mean
674187|NCT01653158|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of CP-751,871 in Cycle 4||30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)|All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort||hr||Standard Deviation|Mean
674188|NCT01653158|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of CP-751,871 in Cycle 1||30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)|All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort||hr||Standard Deviation|Mean
674189|NCT01653158|Secondary|Plasma Decay Half-Life (t1/2) of CP-751,871 in Cycle 4|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)|This OM was not reported due to insufficient data: the parameter was estimable in only 3 of 25 subjects.|||||
674190|NCT01653158|Secondary|Plasma Decay Half-Life (t1/2) of CP-751,871 in Cycle 1|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)|All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort||hr||Standard Deviation|Mean
674191|NCT01653158|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of CP-751,871 in Cycle 4|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)|All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort||mg*hr/L||Standard Deviation|Mean
674192|NCT01653158|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of CP-751,871 in Cycle 1|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)|All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort||mg*hr/L||Standard Deviation|Mean
674205|NCT01653158|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Docetaxel in Cycle 4||30 minutes before CP-751,871 infusion; 1 hour after the end of CP-751,871 infusion; 30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion|Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.||hr||Standard Deviation|Mean
674193|NCT01653158|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of CP-751,871 in Cycle 4|Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf).|30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)|This OM was not reported due to registration error. AUCinf is not scientifically appropriate for repeated dosing (Cycle 4).|||||
674194|NCT01653158|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of CP-751,871 in Cycle 1|Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf).|30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)|All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort||mg*hr/L||Standard Deviation|Mean
674195|NCT01653158|Secondary|Area Under the Curve From Time Zero (Day 1) to Day 22 (AUC(0-d22)) of CP-751,871 in Cycle 4|Area under the plasma concentration versus time curve (AUC) from time zero (Day 1) to Day 22, where Day 22 is the nominal time (504 hours) of the predose sample for the next cycle.|30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)|This OM was not reported since the actual dosing interval (tau) was longer than 3 weeks in some patients and AUC(0-d22) may not accurately represent multiple-dose exposure for these patients. Therefore only AUCtau, which represents exposure for the actual Cycle 4 interval, was reported for Cycle 4 (OM 40).|||||
674196|NCT01653158|Secondary|Area Under the Curve From Time Zero (Day 1) to Day 22 (AUC(0-d22)) of CP-751,871 in Cycle 1|Area under the plasma concentration versus time curve (AUC) from time zero (Day 1) to Day 22, where Day 22 is the nominal time (504 hours) of the predose sample for the next cycle.|30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)|All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort||mg*hr/L||Standard Deviation|Mean
674197|NCT01653158|Secondary|Maximum Observed Plasma Concentration (Cmax) of CP-751,871 in Cycle 4||30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)|All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort||mg/L||Standard Deviation|Mean
674198|NCT01653158|Secondary|Maximum Observed Plasma Concentration (Cmax) of CP-751,871 in Cycle 1||30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)|All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort||mg/L||Standard Deviation|Mean
674199|NCT01653158|Secondary|Systemic Clearance (CL) of CP-751,871 in Cycle 4|CL is a quantitative measure of the rate at which a drug substance is removed from the body.|30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)|All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort||mL/day/kg||Standard Deviation|Mean
674200|NCT01653158|Secondary|Systemic Clearance (CL) of CP-751,871 in Cycle 1|CL is a quantitative measure of the rate at which a drug substance is removed from the body.|30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)|All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort||mL/day/kg||Standard Deviation|Mean
674201|NCT01653158|Secondary|Circulating Tumor Cells (CTCs), CTCs Expressing Insulin-like Growth Factor 1 Receptor (IGF-1R), and Circulating Endothelial Cells (CECs)||Predose on Day 1 and on Day 8 of each cycle, and End of Study (28 days after the last CP-751,871 infusion)|The data of CTCs and CTCs expressing IGF-IR were limited. Analyses of these biomarkers in the aggregate population were not feasible due to insufficient numbers. The data of CECs were not analyzed due to insufficient levels for quantification.|||||
674202|NCT01653158|Secondary|Time to Tumor Progression (TTP)|Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever comes first. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD])|Baseline, every 2 months (approximately 7-10 days prior to the start of the next dose) up to Cycle 17 (1 cycle = 21 days)|This outcome measure (OM) was not analyzed due to incomplete progression reporting, which could not permit accurate estimate of time to tumor progression (TTP).|||||
674203|NCT01653158|Secondary|Number of Participants With Objective Response (OR)|Number of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.|Baseline, every 2 months (approximately 7-10 days prior to the start of the next dose) up to Cycle 17 (1 cycle = 21 days)|This outcome measure was not reported because data was available in individual participant listing only and not statistically summarized for the analysis.|||||
674204|NCT01653158|Secondary|Number of Participants With the Occurrence of Human Anti-human Antibody (HAHA) Response to CP-751,871|The development of HAHA is considered clinically relevant when temporally associated to the onset of adverse events or a significant decrease in the plasma concentrations of CP-751,871. The positive value is defined as ≥3.32.|30 minutes predose at each cycle, End of Study (28 days after the last CP-751,871 infusion), and 150 days after the last CP-751,871 infusion|All enrolled participants who started treatment and had evaluable HAHA data||Participants|||Number
674207|NCT01653158|Primary|Dose Normalized Maximum Observed Plasma Concentration (Cmax(dn)) of Docetaxel in Cycle 4|Maximum Observed Plasma Concentration (Cmax) divided by dose|30 minutes before CP-751,871 infusion; 1 hour after the end of CP-751,871 infusion; 30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion|Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.||ng/mL/(mg/m^2)||Standard Deviation|Mean
674208|NCT01653158|Primary|Dose Normalized Maximum Observed Plasma Concentration (Cmax(dn)) of Docetaxel in Cycle 1|Maximum Observed Plasma Concentration (Cmax) divided by dose|30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion|Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.||ng/mL/(mg/m^2)||Standard Deviation|Mean
674209|NCT01653158|Primary|Maximum Observed Plasma Concentration (Cmax) of Docetaxel in Cycle 4||30 minutes before CP-751,871 infusion; 1 hour after the end of CP-751,871 infusion; 30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion|Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.||ng/mL||Standard Deviation|Mean
674210|NCT01653158|Primary|Maximum Observed Plasma Concentration (Cmax) of Docetaxel in Cycle 1||30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion|Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.||ng/mL||Standard Deviation|Mean
674211|NCT01653158|Primary|Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast(dn)) of Docetaxel in Cycle 4|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) divided by dose|30 minutes before CP-751,871 infusion; 1 hour after the end of CP-751,871 infusion; 30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion|Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.||ng•hr/mL/(mg/m^2)||Standard Deviation|Mean
674212|NCT01653158|Primary|Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast(dn)) of Docetaxel in Cycle 1|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) divided by dose|30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion|Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.||ng•hr/mL/(mg/m^2)||Standard Deviation|Mean
674213|NCT01653158|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Docetaxel in Cycle 4|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|30 minutes before CP-751,871 infusion; 1 hour after the end of CP-751,871 infusion; 30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion|Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.||ng*hr/mL||Standard Deviation|Mean
674214|NCT01653158|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Docetaxel in Cycle 1|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion|Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.||ng*hr/mL||Standard Deviation|Mean
674215|NCT01653158|Primary|Area Under the Curve From Time Zero to 25 Hours Postdose (AUC25) of Docetaxel in Cycle 4|Area under the plasma concentration versus time curve (AUC) from time zero to 25 hours post dose, the nominal time of the last sample (24 hours after end of infusion)|30 minutes before CP-751,871 infusion; 1 hour after the end of CP-751,871 infusion; 30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion|Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.||ng*hr/mL||Standard Deviation|Mean
674216|NCT01653158|Primary|Area Under the Curve From Time Zero to 25 Hours Postdose (AUC25) of Docetaxel in Cycle 1|Area under the plasma concentration versus time curve (AUC) from time zero to 25 hours post dose, the nominal time of the last sample (24 hours after end of infusion)|30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion|Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.||nanogram*hour/millilitre (ng*hr/mL)||Standard Deviation|Mean
674217|NCT01653158|Primary|Recommended Phase 2 Dose (RP2D)||Cycle 1 Day 1 through Cycle 1 Day 21|Safety analysis set: all enrolled participants who started treatment.||mg/kg|||Number
674218|NCT01653158|Primary|Maximum Tolerated Dose (MTD)||Cycle 1 Day 1 through Cycle 1 Day 21|Safety analysis set: all enrolled participants who started treatment, but excluding those who were enrolled in the expansion cohort.||mg/kg|||Number
674219|NCT01653132|Secondary|Number of Participants With Response, Defined as Subjects With ≥ 20% Reduction in Saliva Volume.|measured between baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period|between baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period|||participants|||Number
674220|NCT01653132|Secondary|Number of Participants With Response, Defined as Subjects With ≥ 2 Point Improvement in the DFSS Scores.|measured between baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period.|baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period|||participants|||Number
674255|NCT01652716|Secondary|Change in 2-hour Postprandial Glucose Concentrations From Baseline to Week 16|Change in 2-hour postprandial glucose concentrations from baseline to Week 16.|Baseline to Week 16|Meal Test Evaluable Subjects: Subjects who were randomized and received at least one dose of study drug and who participated in the meal test at Visit 3 and Visit 13, had adequate and reliable data for the postprandial data evaluation, and had adequate study medication exposure.||mg/dL||Standard Error|Least Squares Mean
674221|NCT01653132|Secondary|Change in Drooling Frequency and Severity Scale (DFSS) Scores|"measured between baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period.Drooling Frequency and Severity Score. The Drooling Score equals the sum of the Severity and Frequency sub-scores. The range is 2-9, higher numbers represent worse drooling Drooling Severity Scale
= Never drools, dry
= Mild-drooling, only lips wet
= Moderate- drool reaches the lips and chin
= Severe- drool drips off chin & onto clothing
= Profuse- drooling off the body and onto objects (furniture, books) Drooling Frequency Scale
1. = No drooling 2. = Occasionally drools 3. = Frequently drools 4. = Constant drooling"|baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period|||units on a scale||Standard Deviation|Mean
674222|NCT01653132|Primary|Objectively Measured Percentage Salivary Weight|Percentage change in saliva weight between baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period.|baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period|||percentage change from baseline||Standard Deviation|Mean
674223|NCT01653132|Primary|Objectively Measured Salivary Weight|Change in saliva weight between baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period.|baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period|||gm||Standard Deviation|Mean
674224|NCT01653028|Secondary|Adverse Events|Adverse Events: Incidence of adverse events, assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Adverse events were collected every cycle during treatment and up to one month after treatment. Adverse events were summarized using summary statistics and frequency tables for each separate cohort. Per protocol, analysis was descriptive in nature. In this section, the number of patients that reported a grade 4 or higher event are summarized. A complete listing of Adverse Events is provided in the Adverse Events section below.|During treatment and up to 5 years|All patients that began study treatment were assessed for this endpoint.||participants|||Number
674225|NCT01653028|Secondary|Progression Free Survival (PFS)|The distribution will be estimated by the methods of Kaplan and Meier. The estimates of PFS at specific time points will be calculated (eg, median, 1 year PFS).|The time between registration to disease progression or death, assessed up to 18 months|||Weeks||95% Confidence Interval|Median
674226|NCT01653028|Secondary|Overall Survival (OS)|The distribution will be estimated by the methods of Kaplan and Meier. The estimates of survival at specific time points will be calculated (eg, median, 6 month survival).|The time between registration and death, assessed up to 18 months|||Weeks||95% Confidence Interval|Median
674227|NCT01653028|Primary|The Primary Endpoint for This Trial Was the Percent of Confirmed Tumor Responses. Confirmed Tumor Response to Treatment Was Defined as a Complete or Partial Response(Per RECIST 1.1) on Two Consecutive Evaluations at Least 6 Weeks Apart.|The primary endpoint was estimated by the number of confirmed responses divided by the total number of evaluable patients per cohort. The study used a two stage Simon design to assess the primary endpoint. A confirmed tumor response rate of 5% was considered not promising; an observed confirmed response rate of 25% was considered promising. One confirmed response within the initial 9 patients enrolled within each cohort, expanded enrollment to 24 patients in that cohort. 3 out of 24 patients with confirmed tumor responses was considered evidence that this treatment could be recommended for further testing. This study design yielded 90% power to detect a true confirmed response rate of at least 25% at .10 level of significance if the true rate is at most 5%. There was a 63% chance of stopping early if the true confirmed response rate was 5%.|Up to 18 months|||percentage of patients with response|||Number
674228|NCT01652885|Secondary|Change From Baseline in Signs and Symptoms of Atopic Dermatitis at Day 8, 15, 22 and 29|5 signs and symptoms of atopic dermatitis were: 1) erythema, 2) pruritus, 3) exudation, 4) excoriation and 5) lichenification. The severity of each of these 5 signs and symptoms were assessed on a 4 point scale, ranging from 0 (none) to 3 (severe). Higher scores (for each of the 5 signs and symptoms) indicate higher degree of severity of atopic dermatitis.|Baseline, Day 8, 15, 22, 29|Safety population included all participants who were enrolled and had received any amount of the study drug.||units on a scale||Standard Deviation|Mean
674229|NCT01652885|Secondary|Number of Participants Who Achieved Treatment Success Based on Investigator’s Static Global Assessment (ISGA)|ISGA assess severity of atopic dermatitis on a 5 point scale ranged from 0 (clear) to 4 (maximum severe), where higher scores indicate higher degree of atopic dermatitis. Grades for classification of severity: 0= clear (minor residual discoloration, no erythema or induration or papulation, no oozing or crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration or papulation and no oozing or crusting), 2= mild (faint pink erythema with mild induration or papulation and no oozing or crusting), 3= moderate (pink-red erythema with moderate induration or papulation with or without oozing or crusting) and 4= severe (deep or bright red erythema with severe induration or papulation and with oozing or crusting). Treatment success was defined as ISGA score of 0 or 1, and a minimum improvement of 2 grades in ISGA from Baseline to Day 29.|Baseline up to Day 29|Safety population included all participants who were enrolled and had received any amount of the study drug.||Participants|||Count of Participants
674230|NCT01652885|Primary|Apparent Terminal Half-Life of AN2728 and Major Oxidative Metabolites of AN2728: Day 8|Apparent terminal half-life, of AN2728 and its two identified oxidative metabolites, AN7602 and AN8323 on Day 8 was reported in the outcome measure. Apparent terminal half-life is the time measured for the drug concentration to decrease by one-half in plasma.|Pre-dose (0 hour), 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 8|PK population included participants from the safety population who had completed any portion of the PK day procedures and evaluations. Here, “n” signifies number of participants who were evaluable for specific categories.||hour||Standard Deviation|Mean
674231|NCT01652885|Primary|Area Under the Concentration-Time Curve From Hour Zero To the 12 Hour Post-Dose Measurable Concentration of AN2728 and Major Oxidative Metabolites of AN2728: Day 8|Area under the concentration-time curve from hour zero to the 12 hour post-dose measurable concentration, of AN2728 and its two identified oxidative metabolites, AN7602 and AN8323 on Day 8 was reported in the outcome measure.|Pre-dose (0 hour), 1, 2, 4, 6, 8 and 12 hours post-dose on Day 8|PK population included participants from the safety population who had completed any portion of the PK day procedures and evaluations. Here, 'N' signifies evaluable participants for this outcome measure.||nanogram*hour per milliliter||Standard Deviation|Mean
679177|NCT01586806|Secondary|Patient Satisfaction|Patients will be asked to rate satisfaction on a scale of 0-10 (0=completely dissatisfied, 10=completely satisfied);|Up to 2 days following surgery|||units on a scale||Inter-Quartile Range|Median
674232|NCT01652885|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of AN2728 and Major Oxidative Metabolites of AN2728: Day 8|Time to reach maximum plasma concentration of AN2728 and its two identified oxidative metabolites, AN7602 and AN8323 on Day 8 was reported in the outcome measure.|Pre-dose (0 hour), 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 8|PK population included participants from the safety population who had completed any portion of the PK day procedures and evaluations. Here, 'N' signifies evaluable participants for this outcome measure.||hour||Full Range|Median
674233|NCT01652885|Primary|Maximum Observed Plasma Concentration (Cmax) of AN2728 and Major Oxidative Metabolites of AN2728: Day 8|Maximum observed plasma concentration of AN2728 and its two identified oxidative metabolites, AN7602 and AN8323 on Day 8 was reported in the outcome measure.|Pre-dose (0 hour), 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 8|"PK population included participants from the safety population who had completed any portion of the PK day procedures and evaluations. Here, Number of Participants Analyzed (N) signifies evaluable participants for this outcome measure."||nanogram per milliliter||Standard Deviation|Mean
674234|NCT01652885|Primary|Apparent Terminal Half-Life of AN2728 and Major Oxidative Metabolites of AN2728: Day 1|Apparent terminal half-life, of AN2728 and its two identified oxidative metabolites, AN7602 and AN8323 on Day 1 was reported in the outcome measure. Apparent terminal half-life is the time measured for the drug concentration to decrease by one-half in plasma.|Pre-dose (0 hour), 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 1|PK population included participants from the safety population who had completed any portion of the PK day procedures and evaluations. Here, “n” signifies number of participants who were evaluable for specific categories.||hour||Standard Deviation|Mean
674235|NCT01652885|Primary|Area Under the Concentration-Time Curve From Hour Zero To the 12 Hour Post-Dose Measurable Concentration of AN2728 and Major Oxidative Metabolites of AN2728: Day 1|Area under the concentration-time curve from hour zero to the 12 hour post-dose measurable concentration, of AN2728 and its two identified oxidative metabolites, AN7602 and AN8323 on Day 1 was reported in the outcome measure.|Pre-dose (0 hour), 1, 2, 4, 6, 8 and 12 hours post-dose on Day 1|PK population included participants from the safety population who had completed any portion of the PK day procedures and evaluations.||nanogram*hour per milliliter||Standard Deviation|Mean
674236|NCT01652885|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of AN2728 and Major Oxidative Metabolites of AN2728: Day 1|Time to reach maximum plasma concentration of AN2728 and its two identified oxidative metabolites, AN7602 and AN8323 on Day 1 was reported in the outcome measure.|Pre-dose (0 hour), 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 1|PK population included participants from the safety population who had completed any portion of the PK day procedures and evaluations.||hour||Full Range|Median
674237|NCT01652885|Primary|Maximum Observed Plasma Concentration (Cmax) of AN2728 and Major Oxidative Metabolites of AN2728: Day 1|Maximum observed plasma concentration of AN2728 and its two identified oxidative metabolites, AN7602 and AN8323 on Day 1 was reported in the outcome measure.|Pre-dose (0 hour), 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 1|Pharmacokinetic (PK) population included participants from the safety population who had completed any portion of the PK day procedures and evaluations.||nanogram per milliliter||Standard Deviation|Mean
674238|NCT01652885|Primary|Number of Participants With Clinically Significant Laboratory Test Abnormalities|Laboratory parameters included: hematology (hemoglobin, hematocrit, red blood cell, platelet and white blood cell count, neutrophils, eosinophils, monocytes, basophils and lymphocytes), chemistry (blood urea nitrogen, creatinine, sodium, potassium, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, albumin, total protein and serum pregnancy test [for all female participants]) and urine (urine pregnancy test [for all female participants]). Clinical significance of laboratory parameters was determined at the investigator's discretion.|Baseline (Day 1) up to Day 29|Safety population included all participants who were enrolled and had received any amount of the study drug.||participants|||Number
674239|NCT01652885|Primary|Number of Participants With Clinically Significant Vital Signs Abnormalities|Vital signs (temperature, respiratory rate, pulse, systolic and diastolic blood pressure) were obtained with participant in the seated position, after having sat calmly for at least 5 minutes. Clinical significance of vital signs was determined at the investigator's discretion.|Baseline (Day 1) up to Day 29|Safety population included all participants who were enrolled and had received any amount of the study drug.||participants|||Number
674240|NCT01652885|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death;initial or prolonged inpatient hospitalization; life­ threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Day 29 that were absent before treatment or that worsened relative to pretreatment state.|Baseline (Day 1) up to Day 29|Safety population included all participants who were enrolled and had received any amount of the study drug.||participants|||Number
674241|NCT01652885|Primary|Number of Participants With Local Tolerability Symptoms According to Severity on Day 29|Local tolerability symptoms, burning or stinging, were classified according to severity as: 1) none = no stinging or burning, 2) mild = slight warm, tingling sensation; not really troublesome, 3) moderate = definite warm; tingling or stinging sensation; troublesome and 4) severe = hot, tingling or stinging sensation that caused definite discomfort. Number of participants with local tolerability symptoms according to severity on Day 29 were reported in this outcome measure.|Day 29|Safety population included all participants who were enrolled and had received any amount of the study drug.||participants|||Number
674242|NCT01652885|Primary|Number of Participants With Local Tolerability Symptoms According to Severity on Day 22|Local tolerability symptoms, burning or stinging, were classified according to severity as: 1) none = no stinging or burning, 2) mild = slight warm, tingling sensation; not really troublesome, 3) moderate = definite warm; tingling or stinging sensation; troublesome and 4) severe = hot, tingling or stinging sensation that caused definite discomfort. Number of participants with local tolerability symptoms according to severity on Day 22 were reported in this outcome measure.|Day 22|Safety population included all participants who were enrolled and had received any amount of the study drug.||participants|||Number
679609|NCT01581437|Primary|Time to Ablation of All Sources|total time taken to ablate all sources of rotors/focal sources in driver locations|30 minutes|patients participating undergo mapping using the 64 pole basket catheter||minutes||Standard Deviation|Mean
674243|NCT01652885|Primary|Number of Participants With Local Tolerability Symptoms According to Severity on Day 15|Local tolerability symptoms, burning or stinging, were classified according to severity as: 1) none = no stinging or burning, 2) mild = slight warm, tingling sensation; not really troublesome, 3) moderate = definite warm; tingling or stinging sensation; troublesome and 4) severe = hot, tingling or stinging sensation that caused definite discomfort. Number of participants with local tolerability symptoms according to severity on Day 15 were reported in this outcome measure.|Day 15|Safety population included all participants who were enrolled and had received any amount of the study drug.||participants|||Number
674244|NCT01652885|Primary|Number of Participants With Local Tolerability Symptoms According to Severity on Day 9|Local tolerability symptoms, burning or stinging, were classified according to severity as: 1) none = no stinging or burning, 2) mild = slight warm, tingling sensation; not really troublesome, 3) moderate = definite warm; tingling or stinging sensation; troublesome and 4) severe = hot, tingling or stinging sensation that caused definite discomfort. Number of participants with local tolerability symptoms according to severity on Day 9 were reported in this outcome measure.|Day 9|Safety population included all participants who were enrolled and had received any amount of the study drug.||participants|||Number
674245|NCT01652885|Primary|Number of Participants With Local Tolerability Symptoms According to Severity on Day 8|Local tolerability symptoms, burning or stinging, were classified according to severity as: 1) none = no stinging or burning, 2) mild = slight warm, tingling sensation; not really troublesome, 3) moderate = definite warm; tingling or stinging sensation; troublesome and 4) severe = hot, tingling or stinging sensation that caused definite discomfort. Number of participants with local tolerability symptoms according to severity on Day 8 were reported in this outcome measure.|Day 8|Safety population included all participants who were enrolled and had received any amount of the study drug.||participants|||Number
674246|NCT01652885|Primary|Number of Participants With Local Tolerability Symptoms According to Severity on Day 6|Local tolerability symptoms, burning or stinging, were classified according to severity as: 1) none = no stinging or burning, 2) mild = slight warm, tingling sensation; not really troublesome, 3) moderate = definite warm; tingling or stinging sensation; troublesome and 4) severe = hot, tingling or stinging sensation that caused definite discomfort. Number of participants with local tolerability symptoms according to severity on Day 6 were reported in this outcome measure.|Day 6|Safety population included all participants who were enrolled and had received any amount of the study drug.||participants|||Number
674247|NCT01652885|Primary|Number of Participants With Local Tolerability Symptoms According to Severity on Day 4|Local tolerability symptoms, burning or stinging, were classified according to severity as: 1) none = no stinging or burning, 2) mild = slight warm, tingling sensation; not really troublesome, 3) moderate = definite warm; tingling or stinging sensation; troublesome and 4) severe = hot, tingling or stinging sensation that caused definite discomfort. Number of participants with local tolerability symptoms according to severity on Day 4 were reported in this outcome measure.|Day 4|Safety population included all participants who were enrolled and had received any amount of the study drug.||participants|||Number
674248|NCT01652885|Primary|Number of Participants With Local Tolerability Symptoms According to Severity on Day 2|Local tolerability symptoms, burning or stinging, were classified according to severity as: 1) none = no stinging or burning, 2) mild = slight warm, tingling sensation; not really troublesome, 3) moderate = definite warm; tingling or stinging sensation; troublesome and 4) severe = hot, tingling or stinging sensation that caused definite discomfort. Number of participants with local tolerability symptoms according to severity on Day 2 were reported in this outcome measure.|Day 2|Safety population included all participants who were enrolled and had received any amount of the study drug.||participants|||Number
674249|NCT01652885|Primary|Number of Participants With Local Tolerability Symptoms According to Severity on Baseline|Local tolerability symptoms, burning or stinging, were classified according to severity as: 1) none = no stinging or burning, 2) mild = slight warm, tingling sensation; not really troublesome, 3) moderate = definite warm; tingling or stinging sensation; troublesome and 4) severe = hot, tingling or stinging sensation that caused definite discomfort. Number of participants with local tolerability symptoms according to severity on Baseline were reported in this outcome measure.|Baseline|Safety population included all participants who were enrolled and had received any amount of the study drug.||participants|||Number
674250|NCT01652729|Secondary|Change in 2-hour Postprandial Glucose Concentrations From Baseline to Week 16 (Visit 8)|The change in 2-hour postprandial plasma glucose from baseline (Day 1) to Visit 8 (Week 16) was analyzed using a general linear model including treatment, and baseline HbA1c stratum (< 9% or ≥ 9%) as fixed factors, and the baseline 2-hour postprandial plasma glucose concentrations as a covariate.|Baseline to Week 16|Meal Test Evaluable Population: The Meal Test Evaluable Population consists of all modified ITT subjects who participated in the meal test, consumed at least 75% of the standardized meal and had no missing 2-hour postprandial glucose measurements at both Visit 3 (Day 1) and Visit 8 (Week 16), and have adequate study drug exposure.||mg/dL||Standard Error|Least Squares Mean
674251|NCT01652729|Secondary|Change in Body Weight (kg) From Baseline to Week 28|The change in body weight (kg) from baseline (Day 1) to Week 28/Study Termination.|Baseline to Week 28|Modified Intent-to-Treat: Subjects who were randomized and received at least one dose of study drug.||kg||Standard Error|Least Squares Mean
674252|NCT01652729|Secondary|Change in Fasting Plasma Glucose Concentrations From Baseline to Week 28|The change in fasting plasma glucose concentrations from baseline (Day 1) to Week 28/Study Termination.|Baseline to Week 28|Modified Intent-to-Treat: Subjects who were randomized and received at least one dose of study drug.||mg/dL||Standard Error|Least Squares Mean
674253|NCT01652729|Secondary|Percentage of Subjects Achieving HbA1c <7% at Week 28|Percentage of subjects achieving HbA1c target values of < 7.0% at Week 28/Study Termination.|Baseline to Week 28|Modified Intent-to-Treat: Subjects who were randomized and received at least one dose of study drug.||percentage of subjects|||Number
674254|NCT01652729|Primary|Change in HbA1c (Glycosylated Hemoglobin) From Baseline to Week 28|Absolute change in HbA1c from baseline (Day 1, Visit 3) to Week 28/Study Termination (Visit 11). Hypothesis testing on the primary endpoint followed a serial gated procedure with all tests carried out at a 2-sided significance level of 0.05 to protect the family-wise error rate. These tests were conducted sequentially, and are presented in the statistical analysis section below in the order in which they were performed; each test was the gatekeeper of later tests.|Baseline to Week 28|Modified Intent-to-Treat: Subjects who were randomized and received at least one dose of study drug.||percentage of total hemoglobin||Standard Error|Least Squares Mean
674259|NCT01652716|Primary|Change in HbA1c (Glycosylated Hemoglobin) From Baseline to Week 28|The primary objective of this study was to compare the effect on glycemic control (HbA1c) of exenatide suspension administered once weekly to that achieved by exenatide administered twice daily for 28 weeks in subjects with type 2 diabetes mellitus.|Baseline to Week 28|Modified Intent-to-Treat: Subjects who were randomized and received at least one dose of study drug||Percentage of total hemoglobin||Standard Error|Least Squares Mean
674260|NCT01652703|Secondary|Percent Change From Baseline to Week 12 in Apolipoprotein B/Apolipoprotein A-1 Ratio||Baseline and Week 12|Full analysis set; missing data were imputed using LOCF.||percent change||Standard Error|Least Squares Mean
674261|NCT01652703|Secondary|Percent Change From Baseline to Week 12 in Total Cholesterol/HDL-C Ratio||Baseline and Week 12|Full analysis set; missing data were imputed using LOCF.||percent change||Standard Error|Least Squares Mean
674262|NCT01652703|Secondary|Percent Change From Baseline to Week 12 in VLDL-C||Baseline and Week 12|Full analysis set; missing data were imputed using LOCF.||percent change||Standard Error|Least Squares Mean
674263|NCT01652703|Secondary|Percent Change From Baseline to Week 12 in Apolipoprotein B||Baseline and Week 12|Full analysis set; missing data were imputed using LOCF.||percent change||Standard Error|Least Squares Mean
674264|NCT01652703|Secondary|Percent Change From Baseline to Week 12 in Non-HDL-C||Baseline and Week 12|Full analysis set; missing data were imputed using LOCF.||percent change||Standard Error|Least Squares Mean
674265|NCT01652703|Secondary|Percentage of Participants With an LDL-C Response at Week 12|An LDL-C response was defined as LDL-C < 70 mg/dL (1.8 mmol/L) at Week 12. LDL-C was measured using ultracentrifugation.|Week 12|Full analysis set||percentage of participants|||Number
674266|NCT01652703|Secondary|Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12|LDL-C was measured using ultracentrifugation.|Baseline and Week 12|Full analysis set; missing data were imputed using LOCF.||mg/dL||Standard Error|Least Squares Mean
674267|NCT01652703|Primary|Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12|LDL-C was measured using ultracentrifugation.|Baseline and Week 12|Full analysis set; missing ultracentrifugation (UC) LDL-C at Week 12 was imputed using last observation carried forward (LOCF) and calculated LDL-C.||percent change||Standard Error|Least Squares Mean
674268|NCT01652690|Secondary|Number of Participants With Serious ADRs to Denosumab|Serious adverse events that were considered related to denosumab were classified as serious adverse drug reactions (SADRs). A serious adverse event (SAE) is any AE that also: • is fatal • is life threatening (places the patient at immediate risk of death) • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • is an “other significant medical hazard” that does not meet any of the above criteria.|24 months|Full analysis set||participants|||Number
674269|NCT01652690|Secondary|Number of Participants With Adverse Drug Reactions (ADRs) to Denosumab|Adverse events (AEs) that were considered related to denosumab as evaluated by the investigator were classified as adverse drug reactions (ADRs).|24 months|Full analysis set||participants|||Number
674270|NCT01652690|Primary|Number of Participants Having Osteoporosis Related Laboratory Examinations|Number of participants having osteoporosis related laboratory examinations pre-treatment with denosumab and during the study. Participants may not have been given denosumab injection when they attended each visit.|Pre-baseline (before first denosumab injection) and post-baseline|Full analysis set; n = participants with visits at each time point.||participants|||Number
674271|NCT01652690|Primary|Number of Participants Having Radiologic Bone Assessments|Number of participants having radiologic bone assessments pre-treatment with denosumab and during the study.|Pre-baseline (before first denosumab injection) and during the study (post-baseline)|Full analysis set||participants|||Number
674272|NCT01652690|Primary|Number of Denosumab Post-baseline Injections Received by Each Participant||24 months|Full analysis set||participants|||Number
674273|NCT01652690|Primary|Types of Health Care Providers Administering Denosumab at the Fourth Post-baseline Injection|Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the fourth post-baseline injection.|Month 24|Full analysis set participants who received a fourth post-baseline injection (i.e. at month 24)||participants|||Number
674274|NCT01652690|Primary|Types of Health Care Providers Administering Denosumab at the Third Post-baseline Injection|Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the third post-baseline injection.|Month 18|Full analysis set participants who received a third post-baseline injection (i.e. at month 18)||participants|||Number
674275|NCT01652690|Primary|Types of Health Care Providers Administering Denosumab at the Second Post-baseline Injection|Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the second post-baseline injection.|Month 12|Full analysis set participants who received a second post-baseline injection (i.e. at month 12)||participants|||Number
674276|NCT01652690|Primary|Types of Health Care Providers Administering Denosumab at the First Post-baseline Injection|Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the first post-baseline injection.|Month 6|Full analysis set participants who received a first post-baseline injection (i.e. at month 6)||participants|||Number
674277|NCT01652690|Primary|Types of Health Care Providers Administering an Individual Injection of Denosumab at the Baseline Injection|Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the baseline injection.|Baseline (day 1)|Full analysis set||participants|||Number
674278|NCT01652690|Primary|Number of Participants With a Referral by the Prescribing Physician to Other Health Care Providers for Continuation or Follow-up of Care||24 months|Full analysis set participants who discontinued the study prematurely||participants|||Number
674279|NCT01652690|Primary|Number of Participants Receiving All Prescriptions and Injections of Denosumab|Number of participants receiving all prescriptions and injections of denosumab whether or not the injections are given at the initial prescribing physician’s office.|Months 6, 12, 18 and 24 (corresponding to the first, second, third and fourth post-baseline injections respectively)|Full analysis set||participants|||Number
679610|NCT01581437|Primary|Percentage of Drivers in Right Atrial|To determine where atypical areas of drivers might be.|30 min|||percentage of rotor sources|||Number
674281|NCT01652690|Primary|Number of Participants Receiving All Prescriptions and Injections of Denosumab From the Initial Prescribing Physician’s Office|Number of participants who received all injection(s), including baseline injection, from the initial prescribing site irrespective of total number of injections received on study.|24 months|Full analysis set (all enrolled patients who provided informed consent and received at least one injection)||participants|||Number
674282|NCT01652664|Primary|Mean Change From Baseline in IOP at Month 3|IOP (fluid pressure inside the eye) was assessed using a calibrated tonometer and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye from each participant was chosen as the study eye and only the study eye was used for analysis.|Baseline (Day 0), Month 3|All participants who received study drug and completed at least 1 scheduled on-therapy visit. No imputation was used, therefore the analysis included only observed cases.||mmHg||Standard Error|Mean
674283|NCT01652573|Secondary|Number of Participants With Allergic Reactions at 3 Months|This symptom will be assessed.|Time 3 months|||Participants|||Count of Participants
674284|NCT01652573|Secondary|Number of Participants With Nasal Ulcerations at 3 Months|This symptom will be assessed.|Time 3 months|||Participants|||Count of Participants
674285|NCT01652573|Secondary|Number of Participants With Allergic Reactions at 2 Months|This symptom will be assessed.|Time 2 months|||Participants|||Count of Participants
674286|NCT01652573|Secondary|Number of Participants With Nasal Ulceration at 2 Months|This symptom will be assessed.|Time 2 months|||Participants|||Count of Participants
674287|NCT01652573|Secondary|Number of Participants With Allergic Reactions at 1 Month|This symptom will be assessed.|Time 1 month|||Participants|||Count of Participants
674288|NCT01652573|Secondary|Number of Participants With Nasal Ulceration at 1 Month|This symptom will be assessed.|Time 1 month|||Participants|||Count of Participants
674289|NCT01652573|Secondary|Number of Participants With Allergic Reactions at Baseline|This symptom will be assessed at baseline|Time 0|||Participants|||Count of Participants
674290|NCT01652573|Secondary|Number of Participants With Nasal Ulcerations at Baseline|This symptom will be assessed at baseline|Time 0|||Participants|||Count of Participants
674291|NCT01652573|Secondary|Number of Participants With Nasal Congestion at 3 Months|This symptom will be assessed.|Time 3 months|||Participants|||Count of Participants
674292|NCT01652573|Secondary|Number of Participants With Nasal Congestion at 2 Months|This symptom will be assessed.|Time 2 months|||Participants|||Count of Participants
674293|NCT01652573|Secondary|Number of Participants With Nasal Congestion at 1 Month|This symptom will be assessed.|Time 1 month|||Participants|||Count of Participants
674294|NCT01652573|Secondary|Area Under the Curve for 1,25(OH)2vitamin D|Serum 1,25(OH)2vitamin D will be measured 0 to 24 hours post dose during a 24 hr admission and AUC calculated and results will be compared to baseline values.|Time 3 months|||ng/ml*hr||95% Confidence Interval|Least Squares Mean
674295|NCT01652573|Secondary|Area Under the Curve for TmP/GFR|TmP/GFR will be measured 0 to 24 hours postdose during a 24 hr admission at 3 months and AUC calculated and compared to baseline.|Time 3 months|||mg/100 ml GF*hr||95% Confidence Interval|Least Squares Mean
674296|NCT01652573|Secondary|Number of Patients With Nasal Congestion at Baseline|This symptom will be assessed at baseline|Time 0|||Participants|||Count of Participants
674297|NCT01652573|Secondary|Area Under the Curve for 1,25(OH)2vitamin D|Serum 1,25(OH)2vitamin D will be measured 0 to 24 hours post dose during a 24 hr admission and AUC calculated.|Time 0|||ng/ml*hr||95% Confidence Interval|Least Squares Mean
674298|NCT01652573|Secondary|Area Under the Curve for TmP/GFR|Serum phosphate will be measured 0 to 24 hours postdose during a 24 hr admission, AUC calculated, and fasting Tmp/GFR calculated.|Time 0|||mg/100 ml GF*hr||95% Confidence Interval|Least Squares Mean
674299|NCT01652573|Primary|Area Under the Curve for FGF23|FGF23 will be measured 0 to 24 hours post dose during a 24 hour admission at 3 months and AUC calculated and compared to baseline.|3 months|||pg/ml*hr||95% Confidence Interval|Least Squares Mean
674300|NCT01652573|Primary|Area Under the Curve for FGF23|FGF23 will be measured 0 to 24 hours post dose during a 24 hour admission and AUC calculated.|Time 0|||pg/ml*hr||95% Confidence Interval|Least Squares Mean
674301|NCT01652495|Secondary|Reduction of Pain Severity Expressed as Percentage Change in VAS Score|"VAS score
VAS score is a 10 -cm graduated scale with scores ranging from 0 (no pain) to 10 (unbearable pain) self- reported by patients
Reference: Langley GB and Sheppeard H. The visual analogue scale: its use in pain measurement. Rheumatol Int 1985;5(4):145–148."|180 days after treatment|||percentage of pain reduction||95% Confidence Interval|Mean
674302|NCT01652495|Secondary|Percentage of Patients With Suppression of Hypothalamus-pituitary-adrenal Axis|"Evaluation of blood cortisol and ACTH, free urinary cortisol, urinary levels of methylprednisolone or triamcinolone (depending on the administered drug) by RIA immunoassay and tandem mass assays
Persistent suppression of the HPA axis at the end of the follow up is based on the evidence of ACTH, plasmatic and urinary cortisol levels under reference values"|45 days after treatment|||% of patients with HPA suppression|||Number
674303|NCT01652495|Primary|Functional Improvement Measured According to Percentage Change in Constant Score|"Patients will be evaluated clinically by Constant Score
Constant score: range 0 (total shoulder impairment) to 100 (non impaired shoulder). The score is obtained from two subjective (pain and relation between pain and daily-life activities) - and two objective physician-assessed (strength and range of motion) measurements
Reference: Constant CR and Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987 Jan;(214):160-4."|180 days after treatment|||percentage of improvement Constant score||95% Confidence Interval|Mean
674304|NCT01652287|Other Pre-specified|Changes in Composition of the Microbial Community|The secondary aim was to evaluate the influence of BB-12®-supplemented yogurt and control yogurt on the fecal microbiota of participants and determine any changes in the composition of the microbial community.|Day 10||||||
674305|NCT01652287|Primary|Number of Adverse Events|The primary outcome is to assess the safety of BB-12® yogurt when consumed by generally healthy children. To achieve this aim, data on adverse events will be collected from diaries; calls to the 24-hour advice line; and research assistant phone calls on days 6, 11, 15 and 180, ±2 days. All adverse events will be tabulated by type and charted over time.|Days 0-180|||Number of AE reported|||Number
685592|NCT01499810|Secondary|Change in Mean 24-h Diastolic BP||from baseline to 12 months|Number of participants assessed at 12 months minus 1 participant with unsatisfactory ABPM record||mmHg||Standard Deviation|Mean
674306|NCT01652001|Secondary|Sialometries|"Unstimulated and stimulated salivary flow rates were assessed in all patients. The unstimulated salivary flow rate was obtained by the spit method every 30 seconds for 15 minutes. Saliva was collected in 20 mL plastic containers, which were pre-weighted.
Stimulated whole saliva was obtained by chewing a 1 g piece of paraffin wax for six minutes. Saliva collected during the first minute was discarded, and then collected into the container every 30 seconds."|2 weeks|||mL/min||Standard Deviation|Mean
674307|NCT01652001|Primary|Dry Mouth Questionnaire (DMQ)|"Dry Mouth Questionnaire (DMQ) was used in order to obtain subjective information about the severity of xerostomia before and after treatment with malic acid/placebo.
Every participant answered an initial questionnaire (DMQ 1) about the symptoms related to oral dryness, before receiving a spray (1% malic acid or placebo). After two weeks of applications, patients had to answer DMQ 1 again as well as an additional questionnaire (DMQ 2) about the efficacy of the sprays. Increased DMQ scores indicate improvement of xerostomia. DMQ 1 was used to assess the initial severity of oral dryness and in particular its impact on oral function: problems when chewing, swallowing, speaking and general impact on daily life.
DMQ 1 used a 0-to-4 rating scale where 0 = very dry and 4 = not dry at all. After two weeks of treatment, DMQ 1 was repeated and it was included DMQ 2.
At the end values of DMQ 1 and DMQ 2 were summed"|2 weeks|||units on a scale||Standard Deviation|Mean
674308|NCT01651949|Primary|Percentage of Participants Who Had Study Vaccine Discontinued Due to an Adverse Event|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE.|Up to Month 12|The analysis set includes all participants who received >=1 vaccination and had safety follow-up. Heterosexual and MSM males were combined for safety outcomes.||Percentage of Participants|||Number
674309|NCT01651949|Primary|Percentage of Participants With an Adverse Event|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE.|Up to Month 12|The analysis set includes all participants who received >=1 vaccination and had safety follow-up. Heterosexual and MSM males were combined for safety outcomes.||Percentage of Participants|||Number
674310|NCT01651949|Secondary|Percentage of Participants With Seroconversion to the HPV Types Contained in the 9vHPV Vaccine|Serum antibodies to HPV types were measured with a Competitive Luminex Immunoassay. The serostatus cutoffs (milli Merck U/mL) for HPV types were as follows: HPV Type 6: ≥30; HPV Type 11: ≥16; HPV Type 16: ≥20; HPV Type 18: ≥24; HPV Type 31: ≥10; HPV Types 33, 45, 52, and 58: ≥8.|Four weeks post vaccination 3 (Month 7)|The analysis set includes participants who received the 3 vaccinations, were seronegative to the appropriate HPV type at baseline, and had Month 7 immunogenicity results for the appropriate HPV type. Per-protocol non-inferiority analysis compared heterosexual males and females only.||Percentage of Participants||95% Confidence Interval|Number
674311|NCT01651949|Primary|Percentage of Participants With Elevated Oral Body Temperature (>=37.8° C, >=100° F)|Participants were instructed by the investigator to use the Vaccination Report Card to document evening oral temperature daily after each study vaccination|Up to 5 days after any vaccination|The analysis set includes all participants who received >=1 vaccination and had safety follow-up. Heterosexual and MSM males were combined for safety outcomes.||Percentage of Participants|||Number
674312|NCT01651949|Primary|Percentage of Participants With One or More Injection-site Adverse Experiences Prompted on the Vaccination Report Card|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Injection-site AEs prompted on the Vaccination Report Card (VRC) were erythema, pain, and swelling. Participants were instructed to use the Vaccination Report Card to record AEs daily after each study vaccination.|Up to 5 days after any vaccination|The analysis set includes all participants who received >=1 vaccination and had safety follow-up. Heterosexual and MSM males were combined for safety outcomes.||Percentage of Participants|||Number
674313|NCT01651949|Primary|Geometric Mean Titers (GMTs) to the HPV Types Contained in the 9vHPV Vaccine|Serum antibodies to HPV types 6/11/16/18/31/33/45/52/58 were measured with a Competitive Luminex Immunoassay. Titers are reported in milli Merck Units/mL|Four weeks post vaccination 3 (Month 7)|The analysis set includes heterosexual male and female participants who received the 3 vaccinations, were seronegative to the appropriate HPV type at baseline, and had Month 7 immunogenicity results for the appropriate HPV type. Per-protocol non-inferiority analysis compared heterosexual males and females only.||milli Merck Units/mL||95% Confidence Interval|Geometric Mean
674314|NCT01651936|Secondary|Change From Baseline in the HAQ Disability Index at Week 24|The functional status of the participant was assessed using the Disability Index of the HAQ on a Likert scale. This 20-question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area. The overall score for the Disability Index is the mean of the 8 functional area scores and also ranges from 0 to 3, with a lower score indicating less disability. A negative change from Baseline indicates improvement. This outcome measure applied to Base Study participants only.|Baseline and Week 24|Due to the early termination of the study, analysis for this outcome measure was not performed according to the protocol because complete data were not available.|||||
674375|NCT01650324|Secondary|Change of Dipeptidyl Peptidase 4 (DPP4) Activities Between 48 Hrs Post Dose and 0 hr Predose|Change of plasma DPP4 activity at 48 hrs post dose from predose (0 hr). The values were computed as areas under the DPP4 activity-time curve using ANCOVA model, in which the unit of the activity is pmol/min.|predose (0 hr) and 48 hrs post dose|All enrolled participants.||h*pmol/min||Standard Deviation|Geometric Mean
674315|NCT01651936|Secondary|Percentage of Participants Achieving an ACR50 Response at Week 24|ACR responses are numerical measurements of improvement in multiple disease assessment criteria. An ACR50 response is defined as a ≥50% improvement in 1) swollen joint count (66 joints) and tender joint count (68 joints) (0=Absent; 1=Present) and 2) ≥50% improvement in 3 of the following 5 assessments: a) a participant’s overall assessment of pain on a visual analog scale (VAS, 0=no pain to 100=extreme pain); b) Patient’s Global Assessment of Disease Activity VAS (0=doing very well to 100=doing very poor); c) Investigator’s Global Assessment of Disease Activity VAS (0=doing very well to 100=doing very poor; d) participant’s assessment of function across 8 functional areas as measured by Health Assessment Questionnaire (HAQ), total scores ranging from 0=no difficulty to 24=inability to perform tasks; and e) CRP (decrease indicates improvement). This outcome measure applied to Base Study participants only.|Week 24|Due to the early termination of the study, analysis for this outcome measure was not performed according to the protocol because complete data were not available.|||||
674316|NCT01651936|Secondary|Change From Baseline in the Health Assessment Questionnaire Disability (HAQ Disability Index) at Week 12|The functional status of the participant was assessed using the Disability Index of the HAQ on a Likert scale. This 20-question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area. The overall score for the Disability Index is the mean of the 8 functional area scores and also ranges from 0 to 3, with a lower score indicating less disability. A negative change from Baseline indicates improvement. This outcome measure applied to Base Study participants only.|Baseline and Week 12|Randomized participants in the Base Study who received at least one dose of study drug and had both Baseline and Week 12 HAQ Disability Index measurement||Units on a scale||95% Confidence Interval|Least Squares Mean
674317|NCT01651936|Secondary|Change From Baseline in DAS28-CRP at Week 24|The DAS28-CRP is a continuous parameter based upon a statistically-derived index combining tender joints (28 joints; 0=absent, 1=present; TEN28), swollen joints (28 joints; 0=absent, 1=present; SW28), CRP (decrease indicates improvement), and Patient's Global Assessment of Disease Activity Visual Analog Scale (VAS) (0=doing very well to 100=doing very poor; GH, ). It is defined as follows: DAS28-CRP = 0.56 × SQRT(TEN28) + 0.28 × SQRT(SW28) + 0.36 × ln (CRP+1) + 0.014 × GH + 0.96. The DAS28-CRP is a scale ranging from 0 to 10 with higher values indicating greater RA disease activity. This outcome measure applied to Base Study participants only.|Baseline and Week 24|Due to the early termination of the study, analysis for this outcome measure was not performed according to the protocol because complete data were not available.|||||
674318|NCT01651936|Secondary|Percentage of Participants Achieving an ACR50 Response at Week 12|ACR responses are numerical measurements of improvement in multiple disease assessment criteria. An ACR50 response is defined as a ≥50% improvement in 1) swollen joint count (66 joints) and tender joint count (68 joints) (0 = Absent; 1 = Present) and 2) ≥50% improvement in 3 of the following 5 assessments: a) a participant’s overall assessment of pain on a visual analog scale (VAS, no pain =0 to extreme pain =100); b) Patient’s Global Assessment of Disease Activity VAS (doing very well =0 to doing very poor =100); c) Investigator’s Global Assessment of Disease Activity VAS (doing very well =0 to doing very poor =100 ; d) participant’s assessment of function across 8 functional areas as measured by Health Assessment Questionnaire (HAQ), total scores ranging from no difficulty =0 to inability to perform tasks =24; and e) serum C-Reactive Protein (decrease indicates improvement). This outcome measure applied to Base Study participants only.|Week 12|Randomized participants in the Base Study who received at least one dose of study drug and had at least one post-baseline ACR50 measurement (last observation carried forward)||Percentage of participants|||Number
674319|NCT01651936|Secondary|Percentage of Participants Achieving an ACR20 Response at Week 24|ACR responses are numerical measurements of improvement in multiple disease assessment criteria. An ACR20 response is defined as a ≥20% improvement in 1) swollen joint count (66 joints) and tender joint count (68 joints) (0 = Absent; 1 = Present) and 2) ≥20% improvement in 3 of the following 5 assessments: a) a participant’s overall assessment of pain on a visual analog scale (VAS, no pain =0 to extreme pain =100); b) Patient’s Global Assessment of Disease Activity VAS (doing very well =0 to doing very poor =100); c) Investigator’s Global Assessment of Disease Activity VAS (doing very well =0 to doing very poor =100 ; d) participant’s assessment of function across 8 functional areas as measured by Health Assessment Questionnaire (HAQ), total scores ranging from no difficulty =0 to inability to perform tasks =24; and e) serum C-Reactive Protein (decrease indicates improvement). This outcome measure applied to Base Study participants only.|Week 24|Due to the early termination of the study, analysis for this outcome measure was not performed according to the protocol because complete data were not available.|||||
674320|NCT01651936|Secondary|Percentage of Participants Achieving an American College of Rheumatology (ACR) 20 Response at Week 12|ACR responses are numerical measurements of improvement in multiple disease assessment criteria. An ACR20 response is defined as a ≥20% improvement in 1) swollen joint count (66 joints) and tender joint count (68 joints) (0 = Absent; 1 = Present) and 2) ≥20% improvement in 3 of the following 5 assessments: a) a participant’s overall assessment of pain on a visual analog scale (VAS, no pain =0 to extreme pain =100); b) Patient’s Global Assessment of Disease Activity VAS (doing very well =0 to doing very poor =100); c) Investigator’s Global Assessment of Disease Activity VAS (doing very well =0 to doing very poor =100 ; d) participant’s assessment of function across 8 functional areas as measured by Health Assessment Questionnaire (HAQ), total scores ranging from no difficulty =0 to inability to perform tasks =24; and e) serum C-Reactive Protein (decrease indicates improvement). This outcome measure applied to Base Study participants only.|Week 12|Randomized participants in the Base Study who received at least one dose of study drug and had at least one post-baseline ACR20 measurement (last observation carried forward)||Percentage of participants|||Number
674376|NCT01650324|Secondary|Profile of Pharmacokinetics - Time of Maximum Plasma Concentration (Tmax)|Plasma samples were used to determine the Time of Maximum Plasma Concentration for DBPR108. The placebo group is not included in the table below; this outcome measure only evaluated the DBPR108 groups.|predose (0 hr), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hrs post dose|All participants who received a single dose of DBPR108 25 mg, 100 mg, 300 mg, or 600 mg.||hrs||Full Range|Median
674321|NCT01651936|Primary|Change From Baseline in Disease Activity Score (DAS28) as Measured by C-Reactive Protein (CRP) at Week 12|The DAS28-CRP is a continuous parameter based upon a statistically-derived index combining tender joints (28 joints; 0=absent, 1=present; TEN28), swollen joints (28 joints; 0=absent, 1=present; SW28), CRP (an inflammatory marker, decrease indicates improvement), and Patient's Global Assessment of Disease Activity Visual Analog Scale (VAS) (0=doing very well to 100=doing very poor; GH). It is defined as follows: DAS28-CRP = 0.56 × SQRT(TEN28) + 0.28 × SQRT(SW28) + 0.36 × ln (CRP+1) + 0.014 × GH + 0.96. The DAS28-CRP is a scale ranging from 0 to 10 with higher values indicating greater RA disease activity. This outcome measure applied to Base Study participants only.|Baseline and Week 12|Randomized participants in the Base Study who received at least one dose of study drug and had both Baseline and Week 12 DAS28-CRP measurements||Units on a scale||95% Confidence Interval|Least Squares Mean
674322|NCT01651780|Secondary|Bleeding BARC 3a, BARC Types 1 or 2, and TIMI Minor|The percentage of participants with moderate bleeding as defined by BARC 3a and minor bleeding as defined as BARC type 1 and 2 and TIMI minor is presented.|at 48 hours or hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days) follow-up|Participants in the ITT population.||percentage of participants|||Number
674323|NCT01651780|Secondary|Timing Effect on Bleeding Event Rate up to 48 Hours or Hospital Discharge|The effect of timing on bleeding event rates (the percentage of participants with an incidence of major bleeding) is presented.|Up to 48 hours after procedure or at hospital discharge (but also includes any subsequent hospitalizations)|"Participants in the ITT population with an incidence of major bleeding. Participants were categorized as First half of study site's enrolled participants (Bivalirudin, N=173; UFH, N=173) and Second half of study site's enrolled participants (Bivalirudin, N=171; UFH, N=165). Only sites with >20 participants are included in this analysis."||percentage of participants|||Number
674324|NCT01651780|Secondary|New Onset Atrial Fibrillation/Flutter|The percentage of participants reporting new onset atrial fibrillation/flutter is presented.|at 48 hours or before hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days)|Participants in the ITT population.||percentage of participants|||Number
674325|NCT01651780|Secondary|Acquired Thrombocytopenia|The percentage of participants reporting acquired thrombocytopenia is presented.|at 48 hours or before hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days)|Participants in the ITT population.||percentage of participants|||Number
674326|NCT01651780|Secondary|Major Vascular Complications|The percentage of participants reporting a major vascular complications as defined by VARC is presented.|at 48 hours or before hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days)|Participants in the ITT population.||percentage of participants|||Number
674327|NCT01651780|Secondary|Acute Kidney Injury|The percentage of participants reporting acute kidney injury is presented.|at 48 hours or hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days) follow-up|Participants in the ITT population.||percentage of participants|||Number
674328|NCT01651780|Secondary|Transient Ischemic Attack|The percentage of participants reporting transient ischemic attack is presented.|at 48 hours or before hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days)|Participants in the ITT population.||percentage of participants|||Number
674329|NCT01651780|Secondary|Major Bleeding According to Additional Scales (VARC, TIMI, GUSTO, ACUITY/HORIZONS)|"Percentage of participants with major bleeding according to the following scales:
Valve Academic Research Consortium (VARC)=life threatening, disabling bleeding, or major bleeding
Thrombolysis in Myocardial Infarction (TIMI)=major bleeding
Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO)=severe or moderate
Acute Catheterization and Urgent Intervention Triage StrategY (ACUITY)/Harmonizing Outcomes with RevasculariZatiON and Stents (HORIZONS)=major bleeding"|at 48 hours or hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days) follow-up|Participants in the ITT population.||percentage of participants|||Number
674330|NCT01651780|Secondary|Major Adverse Cardiac Events (MACE) Including Death, Non-fatal MI, and Stroke|The percentage of participants reporting a MACE overall and the individual components of MACE (including death, non-fatal MI, and stroke) are presented.|at 48 hours or before hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days)|Participants in the ITT population.||percentage of participants|||Number
674331|NCT01651780|Secondary|NACE at 48 Hours or Before Hospital Discharge|NACE at 48 hours or before hospital discharge is the composite of major adverse cardiovascular events (MACE) + major bleeding (BARC type ≥3b). The composite of MACE is defined as all-cause mortality, MI, and stroke. A participant was defined to have a composite event if the participant experienced at least 1 of the components. If the participant did not have any of the components, then he or she did not have the composite endpoint. If a participant had more than 1 of the components, he or she was only counted once in the determination of the total number of participants experiencing the composite endpoint.|at 48 hours or before hospital discharge, whichever occurred earlier|Participants in the ITT population.||percentage of participants|||Number
674332|NCT01651780|Primary|Net Adverse Clinical Events (NACE) at up to 30 Days|The net adverse cardiac events (NACE) at 30 days is the composite of major adverse cardiovascular events (MACE) + major bleeding (BARC type ≥3b). The composite of MACE is defined as all-cause mortality, myocardial infarction (MI), and stroke. A participant was defined to have a composite event if the participant experienced at least 1 of the components. If the participant did not have any of the components, then he or she did not have the composite endpoint. If a participant had more than 1 of the components, he or she was only counted once in the determination of the total number of participants experiencing the composite endpoint.|up to 30 days after procedure|Participants in the ITT population.||percentage of participants|||Number
674377|NCT01650324|Secondary|Profile of Pharmacokinetics - Observed Maximum Plasma Concentration (Cmax)|Plasma samples were used to determine the Cmax for DBPR108. The placebo group is not included in the table below; this outcome measure only evaluated the DBPR108 groups.|predose (0 hr), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hrs post dose|All participants who received a single dose of DBPR108 25 mg, 100 mg, 300 mg, or 600 mg.||ng/mL||Standard Deviation|Geometric Mean
674378|NCT01650324|Secondary|Profile of Pharmacokinetics - Area Under the Plasma Concentration-Time Curve (AUC From 0 to Infinity)|Plasma samples were used to determine the AUC from time 0 to infinity for DBPR108. The placebo group is not included in the table below; this outcome measure only evaluated the DBPR108 groups.|predose (0 hr), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hrs post dose|All participants who received a single dose of DBPR108 25 mg, 100 mg, 300 mg, or 600 mg.||ng*h/mL||Standard Deviation|Geometric Mean
674333|NCT01651780|Primary|Major Bleeding (BARC ≥3b) at 48 Hours or Before Hospital Discharge|"Major bleeding (Bleeding Academic Research Consortium [BARC] type ≥3b) was defined as follows:
Bleeds that were evident clinically, or by laboratory or imaging results, which resulted in surgical intervention or administration of IV vasoactive drugs; overt bleeds with a hemoglobin drop of at least 5 grams per deciliter (g/dL); and bleeding that caused cardiac tamponade.
BARC 3c includes intracranial or intraocular bleeds that compromised vision.
BARC type 4 (Coronary Artery Bypass Grafting [CABG]-related bleeding) includes perioperative intracranial bleeding within 48 hours, bleeds that result in reoperation following closure of sternotomy for the purpose of controlling bleeding, bleeds that result in treatment with transfusion of ≥5 units of whole blood or packed red blood cells within a 48 hour period; and chest tube output ≥2 liters (L) within a 24-hour period.
BARC type 5, fatal bleeding, describes bleeds that directly result in death with no other cause."|at 48 hours or discharge, whichever occurs first|Participants in the ITT population.||percentage of participants|||Number
674334|NCT01651351|Secondary|Number of Participants Testing Positive for Hepatitis A Virus (HAV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Parvovirus B19 (PVB19) or Human Immunodeficiency Virus (HIV) Following Treatment With GLASSIA|Number of participants with seroconversion|105 days|Safety Analysis Set||participants|||Number
674335|NCT01651351|Secondary|Number of Possibly or Probably Related Adverse Events That Occurred Between 72 Hours and 14 Days After Infusion|Number of AEs that occurred between 72 hours and 14 day following an infusion and were deemed related to study product administration|72 hours post infusion to 14 days post infusion|Safety Analysis Set||adverse events|||Number
674336|NCT01651351|Secondary|Number of Possibly or Probably Related Adverse Events (AEs) That Began During an Infusion|Number of AEs that occurred during an infusion and were deemed related to study product administration|Day 1 and Day 15|Safety Analysis Set||adverse events|||Number
674337|NCT01651351|Secondary|Number of Infusions With Temporally Associated Adverse Events (AEs) That Began During or Within 72 Hours of Completion of an Infusion|Number of infusions with temporally associated AEs with an onset time during or within 72 hours of infusion completion, regardless of causality assessment|Within 72 hours of the end of infusion|Safety Analysis Set||Infusions|||Number
674338|NCT01651351|Secondary|Number of Infusions With Temporally Associated Adverse Events (AEs) That Began During or Within 24 Hours of Completion of an Infusion|Number of infusions with temporally associated AEs with an onset time during or within 24 hours of infusion completion, regardless of causality assessment|Within 24 hours of the end of infusion|Safety Analysis Set||Infusions|||Number
674339|NCT01651351|Secondary|Number of Infusions With Temporally Associated Adverse Events (AEs) That Began During or Within 1 Hour of Infusion Completion|Number of infusions with temporally associated AEs with an onset time during or within 1 hour of infusion completion, regardless of causality assessment|Within 1 hour of infusion completion|Safety Analysis Set||Infusions|||Number
674340|NCT01651351|Primary|Number of Infusions Associated With a Reduction in Infusion Rate or Discontinuation of Infusion Due to an Adverse Event (Regardless of Adverse Event Causality Assessment)||Day 1 and Day 15|Safety Analysis Set||Infusions|||Number
674341|NCT01651260|Secondary|Ease of Use|Likert scale score provided by clinician (1 very difficult, 2 difficult, 3 neither easy nor difficult, 4 easy, 5 very easy);|Between 1 - 14 days|||% rating with score of 4 and 5|||Number
674342|NCT01651260|Primary|Prevention of Damage and/or Occlusion of Endotracheal (ET) Tube During Use|Number of participants with damage of ET tube and Number of participants with occlusion of ET tube|14 days|||participants|||Number
674343|NCT01651208|Secondary|4-Item Morisky Medication Adherence Scale (MMAS-4)|The Morisky 4-Item Medication Adherence Scale (MMAS-4) is a self-reported measure of medication-taking behavior. Available in 33 languages, it addresses barriers to medication-taking. Each question can be answer as Yes or No for a range of 0-4 points.|At 12 month post stent placement|||Score on a Scale||Standard Deviation|Mean
674344|NCT01651208|Primary|Number of Participants With Appropriate Adherence/ Medication Possession Ratio (MPR)|Medication Possession ratio (MPR) is a continuous multiple interval measure of medication availability. This is a validated method of estimating medication adherence . The medication possession ratio is defined as the sum of the days' supply of medication divided by the number of days between the first fill and the last refill plus the days' supply of the last refill.We will use the previously validated cutpoint of MPR>=.80 to define the binary outcome of Appropriate Adherence|12 months after receiving coronary stent|||participants|||Number
674345|NCT01651104|Secondary|Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 – Day 4 Postvaccination)|Safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 up to and including day 4 after the aTIV vaccination.|From day 1 through day 4 postvaccination|Analysis was done on the safety dataset i.e. the subjects in the exposed population who provided postvaccination safety data.||Number of subjects|||Number
674346|NCT01651104|Primary|Percentages of Subjects Who Achieved SRH Area ≥25 mm2 Against Each of Three Vaccine Strains After One Vaccination of aTIV|"Immunogenicity was measured as the percentage of subjects achieving SRH area ≥25 mm2 against each of three vaccine strains at baseline (day 1) and three weeks after aTIV vaccination (day 22).
This criterion is met according to CHMP guideline if percentage of subjects achieving SRH area ≥25 mm2 is 60% (≥65 years)."|Day 1 and 22|Analysis was done on the PP set.||Percentages of subjects||95% Confidence Interval|Number
674347|NCT01651104|Primary|Geometric Mean Ratio of Subjects Against Each of Three Vaccine Strains After One Vaccination of aTIV|"Geometric mean ratio (GMR) of subjects was calculated as the ratio of postvaccination to prevaccination SRH geometric mean areas (GMAs), directed against each of three vaccine strains, three weeks after vaccination (day 22).
The CHMP criterion was met if the geometric mean increase (GMR, day 22/day 1) in SRH antibody area is >2.0 (≥65 years)."|Day 22|Analysis was done on the PP set.||Ratio||95% Confidence Interval|Number
674379|NCT01650324|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|There were 4 mild adverse events observed during the course of study.|Adverse events were collected from Day -1 (baseline) through the end of the study, up to Day 7.|All enrolled participants.||participants|||Number
674380|NCT01650285|Other Pre-specified|Time to Progression and Overall Survival for Patients-Following Radical Prostatectomy and Were Treated With Cabazitaxel.||24 months||||||
674381|NCT01650285|Secondary|Toxicity Associated With Cabazitaxel and Adjuvant Radiation||2 mos||||||
674348|NCT01651104|Primary|Percentages of Subjects Who Achieved Seroconversion or Significant Increase in SRH Area Against Each of Three Vaccine Strains After One Vaccination of aTIV|"Immunogenicity was measured as the percentage of subjects who achieved seroconversion or significant increase in single radial hemolysis (SRH) area, against each of three vaccine strains, three weeks after vaccination (day 22), evaluated using SRH assay.
Seroconversion or significant increase in SRH area was defined as the percentage of subjects with a negative prevaccination serum (SRH area ≤4 mm2) to a postvaccination SRH area ≥25 mm2; or a significant increase in antibody titer from a non-negative prevaccination serum, i.e., at least a 50% increase in area.
The European (CHMP) criterion is met if percentage of subjects achieving seroconversion or significant increase in SRH area is 30% (≥65 years)."|Day 22|Analysis was done on the per-protocol (PP) set, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis.||Percentages of subjects||95% Confidence Interval|Number
674349|NCT01651000|Secondary|Subjects in the Per Protocol Population With Normal Serum Total 25-hydroxyvitamin D|Subjects in the Per Protocol Population with normal serum total 25-hydroxyvitamin D (>/= 30 ng/mL)|Approximately 6 months|Per protocol||participants|||Number
674350|NCT01651000|Secondary|Subjects in the Intent to Treat Population With Normal Serum Total 25-hydroxyvitamin D|Subjects in the Intent to Treat Population with normal serum total 25-hydroxyvitamin D (>/= 30 ng/dL)|Approximately 6 months|Intent to treat||participants|||Number
674351|NCT01651000|Secondary|Number of Participants in the Per Protocol Population With Decrease in Plasma Intact Parathyroid Hormone (iPTH) of ≥30% From Pre-treatment Baseline Values|Number of subjects in the per protocol population attaining a mean decrease in plasma intact parathyroid hormone (iPTH) of ≥30% from pre-treatment baseline in the efficacy assessment phase (EAP), referred to as responders.|Approximately 6 months|Per protocol||participants|||Number
674352|NCT01651000|Primary|Number of Participants in the Intent to Treat Population With Decrease in Plasma Intact Parathyroid Hormone (iPTH) of ≥30% From Pre-treatment Baseline Values|Number of subjects in the intent to treat population attaining a mean decrease in plasma intact parathyroid hormone (iPTH) of ≥30% from pre-treatment baseline in the efficacy assessment phase (EAP), referred to as responders.|Approximately 6 months|Intent to treat||participants|||Number
674353|NCT01650831|Primary|Positive/Negative for H.Pylori With Modified BreathID|The amount of subjects that produced positive/negative results for H.pylori with modified BreathID|1 hour|Per protocol subjects tested with modified BreathID||participants|||Number
674354|NCT01650831|Primary|Positive/Negative for H.Pylori With Cleared BreathID|The amount of subjects that produced positive/negative results with cleared BreathID device|1 hour|Per protocol positive/negative when testing with marketed BreathID||participants|||Number
674355|NCT01650831|Primary|Percentage of Patients With Dichotomous (Presence/Absence of H.Pylori) Outcome Agreement in Diagnosis of H. Pylori|The marketed (cleared) BreathID device and the investigational modified new generation BreathID device will measure simultaneously before (baseline) and after ingestion of substrate. The subject will be connected to both devices. The maximum time of measurement is 25 minutes.|25 minutes|Only subjects that had no recent knowledge of existing H.pylori infection and who met all protocol criteria and had no major protocol deviations, were included in the final analysis set (PP-per protocol).||Percentage of participants||95% Confidence Interval|Number
674356|NCT01650805|Secondary|Overall Survival|To compare, according to treatment with ponatinib versus imatinib, overall survival|Up to 8 years after the last patient’s first dose||||||
674357|NCT01650805|Secondary|Progression-free Survival|To compare, according to treatment with ponatinib versus imatinib, progression-free survival|Up to 8 years after the last patient’s first dose||||||
674358|NCT01650805|Secondary|Complete Cytogenetic Response (CCyR) Rate|The percentage of Ph+ metaphases in bone marrow (peripheral blood may not be used), with a review of a minimum of 20 metaphases. Responses are defined as follows: Complete (CCyR): 0% Ph+ metaphases.|12 months after first dose|Patients with 12 month assessment||participants|||Number
674359|NCT01650805|Secondary|<10% BCR-ABL^IS Rate|To compare the proportion of patients achieving a ratio of <10% BCR-ABL to ABL transcript levels at 3 months, as measured by the international scale (<10% BCR-ABL^IS), in patients administered ponatinib versus those administered imatinib|3 months after first dose|Patients with 3 month assessment||participants|||Number
674360|NCT01650805|Secondary|MMR Rate|To compare the efficacy of ponatinib with imatinib, as measured by MMR rate, at 5 years|5 years after first dose||||||
674361|NCT01650805|Primary|Major Molecular Response (MMR) Rate at 12 Months|A ratio of reverse transcribed transcript of BCR-ABL to ABL ≤ 0.1% on the international scale, measured by real-time quantitative polymerase chain reaction.|12 months after first dose|Patients with 12 month assessment (due to early termination of the study, none of the endpoints could be evaluated as planned).||participants|||Number
674362|NCT01650779|Secondary|Percent Change From Baseline in Gastrointestinal (GI) Symptoms (Abdominal Pain, Abdominal Distention, and Bowel Irregularities) at Month 2, 4, and 6|Gastrointestinal symptoms (abdominal pain, abdominal distention, and irregular bowel movements) were to be assessed by a modified version of the Irritable Bowel Syndrome (IBS) Severity Scoring System. The modified IBS Severity Scoring System is a 7-item questionnaire. The severity score calculated by summing the scores of 5 of the 7 questions. Each of the 5 questions were scored on a scale of 0 to 100, leading to a total possible score range of 0 to 500, where higher scores indicate more severe gastrointestinal symptoms. The data for this outcome measure was exploratory and to be collected in individual participant listing only.|Baseline, Month 2, 4, 6|The data for this outcome measure was exploratory and to be collected in individual participant listing only. Analysis of this data was planned only if baseline data was collected on a large number of enrolled participants. This was not the case and therefore interpretation of these results were not possible.|||||
674382|NCT01650285|Primary|Maximum Tolerated Dose of Cabazitaxel With Concurrent Adjuvant Radiation|The MTD was not determined secondary to the study closing early. That being said the numbers provided below show that 4 patients were treated on study to aide in the investigation of the MTD. Only 1 dose was fully evaluated which was 5mg/m2|2 mos|while 5 participants were enrolled only 4 completed treatment as patients # 5 only received part of day 1 therapy secondary to an AE and therefore is not included in the assessment.||mg/m2|||Number
674383|NCT01650246|Primary|Incidence of Treatment-emergent Adverse Events (TEAEs)||Up to approximately 2 years|Safety Population||TEAEs|||Number
674363|NCT01650779|Secondary|Percent Change From Baseline in Urine GL-3 at Month 2, 4, and 6|Percent change from baseline = ([post-baseline value minus baseline value] divided by [baseline value]) multiplied by 100. For levels reported as BQL, the LLOQ value was divided by 2 and used in the calculation to estimate values in samples that were BQL. The LLOQ for urine GL-3 was 0.2 mcg/mL. The absolute values were calculated in microgram per millimole (mcg/mmol) of creatinine by dividing GL-3 (mcg/mL) by creatinine (mg/mL) and multiplying by 113.13 (mg/mmol), the molecular weight of creatinine. For levels reported BQL, the absolute values were calculated in microgram per millimole (mcg/mmol) of creatinine by dividing 0.1 (mcg/mL) by creatinine (mg/mL) and multiplying by 133.13 (mg/mmol). This study is exploratory because little is known about the dose-response of these biomarkers to ERT or about the clinical significance of the biomarkers.|Baseline, Month 2, 4, 6|All enrolled participants were included in the analysis. Here, 'n' signifies participants with urine GL-3 assessment at the specified time point.||percent change||Full Range|Median
674364|NCT01650779|Secondary|Percent Change From Baseline in Plasma Globotriaosylceramide (GL-3) at Month 2, 4 and 6|Percent change from baseline = ([post-baseline value minus baseline value] divided by [baseline value]) multiplied by 100. For levels reported as BQL, the LLOQ value was divided by 2 and used in the calculation to estimate values in samples that were BQL. The LLOQ for plasma GL-3 was 2.0 microgram per milliliter (mcg/mL). This study is exploratory because little is known about the dose-response of these biomarkers to ERT or about the clinical significance of the biomarkers.|Baseline, Month 2, 4, 6|All enrolled participants were included in the analysis. Here, 'n' signifies participants with plasma GL-3 assessment at the specified time point.||percent change||Standard Deviation|Mean
674365|NCT01650779|Primary|Percent Change From Baseline in Plasma Deacylated Globotriaosylceramide (Lyso-GL-3) at Month 2, 4 and 6|Percent change from baseline = ([post-baseline value minus baseline value] divided by [baseline value]) multiplied by 100. For levels reported as below quantitative limit (BQL), the lower limit of quantitation (LLOQ) value was divided by 2 and used in the calculation to estimate values in samples that were BQL. The LLOQ for plasma lyso-GL-3 was 5.0 nanogram per milliliter (ng/mL). This study is exploratory because little is known about the dose-response of these biomarkers to enzyme replacement therapy (ERT) or about the clinical significance of the biomarkers.|Baseline, Month 2, 4, 6|All enrolled participants were included in the analysis. Here, 'n' signifies participants with plasma Lyso-GL-3 assessment at the specified time point.||percent change||Standard Deviation|Mean
674366|NCT01650519|Secondary|Measurement of the Efficacy of IV Ibuprofen for the Treatment of Postoperative Pain as Measured by the Amount of Time to Rescue Medication in the Postoperative Period Through Discharge|Measurement of the amount of time to rescue medication in the postoperative period.|24 hours|||Hours||Standard Deviation|Mean
674367|NCT01650519|Secondary|Measurement of the Efficacy of IV Ibuprofen for the Treatment of Postoperative Pain as Measured by the Pain Intensity as Assess by Patient Pain Intensity (VAS) in the Post-surgical Period, Through 24 Hours|"Measurement of the efficacy of IV ibuprofen for the treatment of postoperative pain as measured by patient pain intensity (Visual Analog Scale, VAS) in the post-surgical period through 24 hours post-procedure. The VAS is a continuous scale made up of a horizontal line, 100 mm in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The subject is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the No Pain anchor and the subject's mark. The score would be between 0 and 100. Subject's were contacted at 24 hour post-discharge during a follow-up phone contact and asked to completed the VAS at Rest and VAS with Movement and return both completed VAS assessments via the envelope provided. The analysis was performed on the VAS assessments returned to the study site."|24 Hours|||units on a scale||Standard Error|Mean
674368|NCT01650519|Secondary|Incidence of Serious Adverse Events (SAEs).|Measurement of the incidence of serious adverse events.|24 hours|||Number of Events|||Number
674369|NCT01650519|Secondary|Patient Satisfaction.|"Measurement of patient satisfaction post-procedure. During the post-treatment period, subjects were asked to complete a satisfaction questionnaire (Quality of Recovery - 40 or QoR-40) defining their quality of recovery at 24 hours following surgery. The QoR - 40 is a 40-item questionnaire that provides a global score and subscores across five dimensions of quality of recovery: emotions (minimum score = 6, maximum score = 30), physical comfort (minimum score = 8, maximum score = 40), patient support (minimum score = 7, maximum score = 35), physical independence (minimum score = 5, maximum score = 25), and pain (minimum score = 7, maximum score = 35). Higher subscores represent a better outcome.
Subscores are added to create a Global QoR-40 score. Global scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery)."|24 hours|||units on a scale||Standard Deviation|Mean
674370|NCT01650519|Secondary|Time to Discharge.|Measurement of the time to discharge in the postoperative period.|24 hours|||Hours||Standard Deviation|Mean
674371|NCT01650519|Secondary|Measurement of the Efficacy of IV Ibuprofen for the Treatment of Postoperative Pain as Measured by the Amount of Rescue Medication in the Postoperative Period Through Discharge|Measurement of the amount of rescue medication in the postoperative period.|24 hours|||milligrams||Standard Deviation|Mean
674372|NCT01650519|Primary|Efficacy of IV Ibuprofen for Post-op Pain.|"Measurement of the efficacy of IV ibuprofen for the treatment of postoperative pain as measured by patient pain intensity (Visual Analog Scale, VAS) upon first possible assessment following surgery. The VAS is a continuous scale compromised of a horizontal line, one hundred millimeters in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the No Pain anchor and the subject's mark. The score would be between o and 100."|first possible assessment following surgery|||units on a scale||Standard Deviation|Mean
674373|NCT01650350|Secondary|To Assess the Toxicity Associated With Low Dose Naltrexone for Melanoma, CRPC and Renal Cancer.||3 months||||||
674374|NCT01650350|Primary|Number of Responses to Low Dose Naltrexone for Patients With Advanced Melanoma, Castrate Refractory Prostate Cancer (CRPC) or Renal Cancer Via RECIST|Response will be assessed via RECIST 1.1 criteria utilizing interval CT scans and physical exam after every 3 cycles of treatment (i.e. every 12 weeks).|approximately every 3 months CT, every month physical, up to 6 months|||participants|||Number
674384|NCT01650246|Primary|Proportion of Subjects With a Serum Urate (sUA) Level That is < 6.0 mg/dL||Month 1|Safety Population||Subjects|||Number
674521|NCT01648140|Secondary|Mean Change From Baseline in ECG Heart Rate Values at the Indicated Time Points After Week 12|The ECG data was only collected “Perform as needed”, therefore, no such summary table was generated. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4|Safety Population|||||
674399|NCT01649804|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI)|The Health Assessment Questionnaire Disability Index (HAQ-DI) is a participant-completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each item was scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores divided by the number of domains answered. Total possible scores range from 0 to 3, where 0=least difficulty, and 3=extreme difficulty.|End of Study (Week 104 or early withdrawal)|Analysis population included all the enrolled participants in the study.||units on a scale||Standard Deviation|Mean
674400|NCT01649804|Secondary|Number of Participants With Decreased, Unchanged, and Increased Participant Global Assessment of Pain|"A participant's overall assessment of pain on a VAS was assessed with a question concerning the amount of pain due to arthritis. Pain was assessed on a 100 mm VAS scale with a left-hand marker no pain (0 mm) or right-hand marker extreme pain (100 mm)."|Week 12 and Week 104|"Analysis population included all the evaluable participants for this outcome measure. n included all the participants analyzed on that particular time point."||participants|||Number
674401|NCT01649804|Secondary|Number of Participants With Decreased, Unchanged, and Increased Participants Global Assessment of Disease Activity|The participant global assessment of disease activity was measured using a 100 mm VAS ranging from 0=very good to 100=very bad.|Week 12 and Week 104|"Analysis population included all the evaluable participants for this outcome measure. n included all the participants analyzed on that particular time point."||participants|||Number
674402|NCT01649804|Secondary|Time to Rheumatoid Arthritis (RA) Flare|RA flare was defined as any worsening of the participant’s disease activity that in the opinion of the Investigator required treatment intensification beyond supportive therapy which included restarting of the study drug treatment. Time to RA flare was defined as the period of drug-free remission until documentation of RA flare. Drug-free remission was defined as clinical remission (based on DAS28-ESR < 2.6 and /or SDAI ≤ 3.3) for two consecutive assessment visits, followed by discontinuation of tocilizumab, at the Investigator's discretion, at the second assessment visit.|End of Study (Week 104 or early withdrawal)|This outcome could not be evaluated as there were no participants who had achieved drug-free remission, per protocol definition.|||||
674403|NCT01649804|Secondary|Number of Participants With Decreased, Unchanged, and Increased Swollen Joint Count (SJC)|Swollen joint count was performed by a skilled assessor, evaluating 66 joints for swelling.|Week 12 and Week 104|"Analysis population included all the evaluable participants for this outcome measure. n included all the participants analyzed on that particular time point."||participants|||Number
674404|NCT01649804|Secondary|Number of Participants With Decreased, Unchanged, and Increased Tender Joint Count (TJC)|Tender joint count was performed by a skilled assessor, evaluating 68 joints for tenderness.|Week 12 and Week 104|"Analysis population included all the evaluable participants for this outcome measure. n included all the participants analyzed on that particular time point."||participants|||Number
674405|NCT01649804|Secondary|Number of Participants With Remission, Low, Medium, and High Disease Activity, as Measured by Simplified Disease Activity Index (SDAI)|The SDAI was defined as the numerical sum of 5 outcome parameters: tender and swollen joint count (based on a 28-joint assessment), participant and physician global assessment of disease activity on a 100 millimeter (mm) Visual analogue scale (VAS) (VAS; 0 = no disease activity and 100 = worst disease activity) and level of C-reactive protein (CRP) (milligram per deciliter [mg/dl], normal < 1 mg/dl). SDAI total score = 0-86 where a higher score reflects worsening disease. SDAI <=3.3 indicates clinical remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high (or severe) disease activity.|Screening and End of Study (Week 104 or early withdrawal)|Analysis population included all the enrolled participants in the study.||participants|||Number
674582|NCT01647542|Secondary|Percentage of Participants With HbA1c <7% at Week 24||Week 24|FAS included of all randomized participants who received at least 1 dose of double blind study medication. Only Participants with a baseline and at least 1 post baseline value were included.||Percentage of participants|||Number
674406|NCT01649804|Secondary|Number of Participants With Remission, Low, Medium, and High Disease Activity, as Measured by Disease Activity Index 28 Erythrocyte Sedimentation Rate (DAS28-ESR)|The DAS28 (ESR) score is a measure of the participant's disease activity. It is calculated using the tender joint count (28 joints), swollen joint count (28 joints), erythrocyte sedimentation rate (ESR) and general health status. The DAS28-ESR scale ranges from 0 to 10, where higher scores represent higher disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity, DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission.|Screening and End of Study (Week 104 or early withdrawal)|Analysis population included all the enrolled participants in the study.||participants|||Number
674407|NCT01649804|Primary|Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs)|An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. A SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant. Adverse Events of Special Interest for this study were: Serious and/or medically significant infections; myocardial infarction/Acute coronary syndrome; Gastrointestinal perforation; Malignancies; Anaphylaxis/hypersensitivity reactions; Demyelinating disorders; Stroke and Serious and/or medically significant bleeding and hepatic events.|End of Study (Week 104 or early withdrawal)|Analysis population included all the enrolled participants in the study.||percentage of participants|||Number
674408|NCT01649791|Secondary|Expression of B-CLL Co-stimulatory Ligands, Mic-A, and Mic-B Assessed by Flow Cytometry|PI left the institute and the data was not collected.|8 days|No participants were analyzed.|||||
674409|NCT01649791|Secondary|Incidence of Immune Mediated Flare Reaction|Number of participants with Tumour flare.|24 months|All treated and eligible patients.||participants|||Number
674410|NCT01649791|Secondary|Overall Response Rate (CR+PR)||24 months|All treated and eligible patients.||percentage of participants|||Number
674411|NCT01649791|Primary|Median Progression-free Survival||24 months|All treated and eligible patients.||months||95% Confidence Interval|Median
674412|NCT01649557|Secondary|Percentage of Participants Who Discontinued Due to Lack of Efficacy.|Discontinuation rate for the participants discontinued due to lack of efficacy were examined.|Last Visit|The efficacy analysis dataset comprised those participants who received study medication of brexpiprazole and had at least one Post-Baseline assessment for PANSS total score.||Percentage of participants.|||Number
674413|NCT01649557|Secondary|Percentage of Participants With a Positive Response Rate.|Response rate was defined as a reduction of ≥ 30% from Baseline in PANSS total score or CGI-I score of 1 (very much improved) or 2 (much improved) at the Last Visit.|Last Visit|The efficacy analysis dataset comprised those participants who received study medication of brexpiprazole and had at least one Post-Baseline assessment for PANSS total score.||Percentage of participants|||Number
674414|NCT01649557|Secondary|Change From Baseline in PANSS Negative Subscale Score.|The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. In negative subscale the severity was rated for the following 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS negative symptom score ranges from 7-49, with higher scores indicating more severe symptoms.|Baseline, Day 4, Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and Last Visit|The efficacy analysis dataset comprised those participants who received study medication of brexpiprazole and had at least one Post-Baseline assessment for PANSS total score.||Units on a scale||Standard Deviation|Mean
674415|NCT01649557|Secondary|Change From Baseline in PANSS Positive Subscale Score.|The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. In positive subscale, the 7 positive symptom constructs were: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS positive symptom score ranges from 7-49, with higher scores indicating more severe symptoms.|Baseline, Day 4, Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and Last Visit|The efficacy analysis dataset comprised those participants who received study medication of brexpiprazole and had at least one Post-Baseline assessment for PANSS total score.||Units on a scale||Standard Deviation|Mean
674416|NCT01649557|Secondary|Mean Clinical Global Impression- Improvement Scale (CGI-I) Total Score.|The efficacy of study medication was rated for each participant using the CGI-I. The investigator rated the participants total improvement whether or not it was due to the drug treatment. All responses were compared to the participants condition at Screening/Baseline (i.e, Week 6 visit of Protocol NCT00905307). Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.|Day 4, Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and Last Visit|The efficacy analysis dataset comprised those participants who received study medication of brexpiprazole and had at least one Post-Baseline assessment for PANSS total score.||Units on a scale||Standard Deviation|Mean
674417|NCT01649557|Secondary|Change From Baseline in Personal and Social Performance Scale (PSP) Total Score.|The PSP was a validated clinician-rated scale that measured personal and social functioning in four domains: socially useful activities (e.g, work and study), personal and social relationships, self-care, and disturbing and aggressive behaviors. Impairment in each of these domains was rated as absent, mild, manifest, marked, severe, or very severe. These ratings were then converted to a total score based on a 100-point scale using algorithms to identify the appropriate 10-point interval, and the rater’s judgment that determined the total score within the 10-point interval. Participants with a PSP total score of 71 to 100 were considered to have mild functional difficulty. Scores of 31 to 70 represented manifest disabilities of various degrees and ratings of 1 to 30 indicated minimal functioning that required intense support and/or supervision.|Baseline, Week 1, 2, 6, 26, 52 and Last Visit|The efficacy analysis dataset comprised those participants who received study medication of brexpiprazole and had at least one Post-Baseline assessment for PANSS total score.||Units on a scale||Full Range|Median
674418|NCT01649557|Secondary|Change From Baseline in Clinical Global Impression- Severity of Illness Scale (CGI-S) Score.|The severity of illness for each participant were rated using the CGI-S. To perform this assessment, the investigator were to answer the following question: “Considering your total clinical experience with this particular population, how mentally ill was the participant at that time?” Response choices include: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.|Baseline, Day 4, Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and Last Visit|The efficacy analysis dataset comprised those participants who received study medication of brexpiprazole and had at least one Post-Baseline assessment for PANSS total score.||Units on a scale||Standard Deviation|Mean
674419|NCT01649557|Secondary|Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) by Study Week and at the Last Visit.|The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 that indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. The PANSS total score was the sum of the rating scores for 7 positive subscale items, 7 negative subscale items, and 16 general psychopathology subscale items from the PANSS panel. The PANSS total score ranges from 30-210, with higher scores indicating more severe symptoms.|Baseline, Day 4, Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and Last Visit|The efficacy analysis dataset comprised those participants who received study medication of brexpiprazole and had at least one Post-Baseline assessment for PANSS total score.||Units on a scale||Standard Deviation|Mean
674420|NCT01649557|Primary|Number of Participants With AEs in 52-Week Enrollers.|AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a participant while enrolled in the trial, whether or not it was considered drug related by the investigator. A SAE was any untoward medical occurrence that resulted in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. A TEAE was defined as an AE that started after start of study medication or an AE that continued from baseline and that worsened, was serious, was study medication related, or resulted in death, discontinuation, interruption, or reduction of study medication.|From Baseline up to 52 weeks|Those participants who received at least one dose of open-label brexpiprazole and who were enrolled in the 52-week study.||Participants|||Number
674421|NCT01649557|Primary|Number of Participants With Adverse Events (AEs) During First 6 Weeks.|AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a participant while enrolled in the trial, whether or not it was considered drug related by the investigator. A serious adverse event (SAE) was any untoward medical occurrence that resulted in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. A treatment-emergent AE (TEAE) was defined as an AE that started after start of study medication or an AE that continued from baseline and that worsened, was serious, was study medication related, or resulted in death, discontinuation, interruption, or reduction of study medication.|From Baseline up to 6 weeks|The safety dataset comprised of those participants who received at least one dose of open-label brexpiprazole and were enrolled in the 6-week study.||Participants|||Number
674422|NCT01649505|Secondary|Serious and Nonserious Adverse Events and Complications||Up to day 180 post-operation||||||
674423|NCT01649505|Secondary|Quantity of Post-operative Drainage|Defined as total volume of drainage recorded (in ml) by nurses while the patient is in the hospital and by patient himself/herself when discharged home, until the removal of the drain by a doctor once it reaches less than 50 ml per day. Wilcoxon rank sum test will be used to compare the drainage volume of the two groups.|Up to day 10 post-operation||||||
674424|NCT01649505|Secondary|Proportion of Patients Who Experienced Wound Infections, Wound Separation, or Any Other Surgical Complications|Computed with 95% confidence interval using exact method. Two-sided Fisher’s exact test will be used to evaluate whether the wound complication rate are significantly different for the two treatment groups, and the odds ratio with 95% confidence interval will be computed.|Up to day 180 post-operation||||||
674425|NCT01649505|Primary|Proportion of Patients in Each Arm Who Develop Post-operative Seromas|Computed with 95% confidence interval using exact method. The difference of seroma rate in the two groups will be computed with 95% confidence interval using exact method. Two-sided Fisher’s exact test will be used to evaluate whether the seroma rate are significantly different for the two treatment groups.|Up to day 180 post-operation||||||
674426|NCT01649362|Secondary|Breastfeeding Rate at Discharge||hospital discharge, an expected average of 5 weeks from the beginning of oral feeding introduction|||participants|||Number
674427|NCT01649362|Secondary|Length of Hospital Stay||participants were followed for the duration of hospital stay, an expected average of 5 weeks|||days||Standard Deviation|Mean
674428|NCT01649362|Primary|Length of Transition Period|transition period was defined as the period from the introduction of enteral feeding to full enteral feeding|participants were followed from date of randomization until full enteral feeding was acquired,an expected average of 5 weeks|||days||Standard Deviation|Mean
674429|NCT01649297|Secondary|Fasting Plasma Glucose (FPG) Change From Baseline at Week 16|"Change from baseline in FPG (mg/dL) after 16 weeks of treatment. The term 'baseline' refers to the last observation prior to the first intake of any randomised study medication.
Means provided are the adjusted means."|Baseline and 16 weeks|FAS with LOCF has been used for FPG analyses||mg/dL||Standard Error|Mean
674430|NCT01649297|Primary|HbA1c (Glycosylated Haemoglobin) Change From Baseline at Week 16|"Change from baseline in HbA1c (%) after 16 weeks of treatment. The term 'baseline' refers to the last observation prior to the first intake of any randomised study medication.
Means provided are the adjusted means."|Baseline and 16 weeks|"Full Analysis Set (FAS) is the basis for the intention-to-treat analysis. FAS with last observation carried forward (LOCF) imputation is used as the primary method of accounting for missing data.
Values after the patient started rescue medication were excluded from analysis (and imputed with an LOCF procedure)."||percentage of HbA1c||Standard Error|Mean
674431|NCT01649232|Secondary|Number of Omission and Commission Errors of Behavior Task|After VCPT task, errors by Omission (lack of response in test GO) and by commission (lack of suppression in NOGO and NOVELTY test) were automatically counted for each subject.|From September to December 2012|The number of participants needed for study completion is between 20 and 40 for pilot study if it is homogeneous in patients with clinical signs and symptoms, to test efficacy and safety of noninvasive Brain Stimulation.||Number of omission and commision errors||Standard Deviation|Mean
674432|NCT01649232|Secondary|Reaction Time (Behavior Task)|"All subjects performed a Visual continuous performance task (VCPT) with GO/NOGO paradigm. It consists of three types of stimuli: 1) twenty animals (A), 2) twenty images of different plant (P), 3) Twenty images of people of different professions (H) which is present with an artificial sound called Novel 20msec and.Thus, each pair of stimulus is presented for 100 milliseconds, at intervals of one second of duration between each block. The objective of is to press a button as quickly as possible while observing the pairs AA, situation called GO, while trying not to press when observes other types of pairs. This latency of response (reaction time) was mensured. Pairs are called GO(AA) NOGO(AP), IGNORE(PP) and NOVEL(PH + Sound). Errors by omission (lack of response in test GO) and by commission (lack of suppression in NOGO test) were be automatically counted for each subject."|From September to December 2012|||milliseconds||Standard Deviation|Mean
674433|NCT01649232|Secondary|Event-related Potentials Latency (ERPs)|ERPs to the GO/NOGO task will be examined for changes as a result of treatment. Assessments were made at baseline (before stimulation), after the 10-12 days of stimulation, and at 1 and 3 months after stimulation. Event related potentials (ERP) generated from a visual continuous performance task (VCPT) are employed to access the early stages of information processing (Mueller et al., 2011; Kropotov, 2008) and performing at a GO/NOGO paradigm may be used to study the mechanisms of the brain’s executive functions (Falkenstein et al., 1995). Amplitude and latency of ERP activity recorded from a subject can be compared to normalized databases to predict a possible hyper or hypo function of cerebral circuits. These ERP were recorded on 19 separeted channels according international 10-20 system. Electrode names are derived by brain lobule which is is located below and position, e.g., Pz is Parietal on position zero (midline) and Cz is Central Midline.|From September to December 2012|||milliseconds||Standard Deviation|Mean
674434|NCT01649232|Secondary|Event-related Potentials Amplitude (ERPs)|ERPs to the GO/NOGO task will be examined for changes as a result of treatment. Assessments were made at baseline (before stimulation), after the 10-12 days of stimulation, and at 1 and 3 months after stimulation. Event related potentials (ERP) generated from a visual continuous performance task (VCPT) are employed to access the early stages of information processing (Mueller et al., 2011; Kropotov, 2008) and performing at a GO/NOGO paradigm may be used to study the mechanisms of the brain’s executive functions (Falkenstein et al., 1995). Amplitude and latency of ERP activity recorded from a subject can be compared to normalized databases to predict a possible hyper or hypo function of cerebral circuits. These ERP were recorded on 19 separeted channels according international 10-20 system. Electrode names are derived by brain lobule which is is located below and position, e.g., Pz is Parietal on position zero (midline) and Cz is Central Midline.|From September to December 2012|The number of participants needed for study completion is between 20 and 40 for pilot study if it is homogeneous in patients with clinical signs and symptoms, to test efficacy and safety of noninvasive Brain Stimulation.||microVolts||Standard Deviation|Mean
674435|NCT01649232|Primary|Clinical Assessment (Amen Questionnaire)|"The Amen Attention Deficit Disorder (ADD) Type Questionnaire is a 71-question self-test that evaluates the ADD syndrome. 0 never, 1 rarely, 2 Occasionally, 3 Often and 4 Very Often. Consists of a series of questions that evaluate five brain systems: basal ganglia (23 items), Cingular System (17 items), Temporal System (16 items), Prefrontal Cortex (24 items) and deep limbic system (20 items). Each system has a maximum score of 4, and if this punctuation is greater than 1.7 it is possible that the system is deviated from normality and implicated in AD/HD behavior.
The minimal average score is 5 (Best) and the maximum is 20 (Worst). More than four is suspicious of diagnosis, six or more of a score of three or four is needed to make diagnosis. Meets the criteria for inattentiveness (six or more on questions 1-14) and also scores six or more on the cingular system questions (24-36 items), over-focused ADD subtype is suspected."|From September to December 2012|The number of participants needed for study completion is between 20 and 40 for pilot study if it is homogeneous in patients with clinical signs and symptoms, to test efficacy and safety of noninvasive Brain Stimulation.||units on a scale||Standard Deviation|Mean
674436|NCT01649180|Secondary|Tumor Tissue Banking|"To bank tumor tissue (formalin-fixed, paraffin-embedded tumor blocks) for retrospective examination of the molecular pathophysiologic mediators of tumorigenesis and progression such as phospho-protein expression of MAPK signaling network intermediates in endothelial cells. Banking of tumor tissue is optional but strongly encouraged.
Note: None of the 3 patients submitted tumor tissues so the analysis won't be performed."|Baseline||||||
674437|NCT01649180|Secondary|Biospecimen Banking for SNPs Analysis|"To bank biospecimens for the retrospective determination of whether baseline single nucleotide polymorphisms (SNPs) in angiogenesis-related genes predict response to treatment (candidate gene approach). Banking of PBMC is optional but strongly encouraged.
Note: The SNP genotyping analysis was not performed because the study stopped early and only 3 patients were enrolled. Therefore, the analysis to evaluate the association between baseline SNPs in angiogenesis-related genes and response was not be done."|Baseline||||||
674438|NCT01649180|Secondary|Biospecimen Banking for IL-8 and VEGF-A|"To bank biospecimens for the retrospective determination of whether baseline or changes in cytokine levels of IL-8 and VEGF-A predict response to treatment in this setting. Banking of plasma and serum is optional but strongly encouraged.
Note: The assays to assess cytokine levels of IL-8 and VEGF-A were not performed because the study stopped early and only 3 patients were enrolled. Therefore, the analysis to evaluate the associations between response and IL-8 as well as VEGF-A was not be done."|Baseline and 8 weeks||||||
674439|NCT01649180|Secondary|Overall Response Rate|"Best overall response was evaluated using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v 1.0). Response is defined as complete response or partial response.
Complete Response (CR): disappearance of all target lesions Partial Response (PR): >=30% decrease in the sum of the longest diameter of target lesions"|Assessed every 12 weeks up to 36 months|all participants||proportion of participants||95% Confidence Interval|Number
674440|NCT01649180|Primary|Progression-free Survival|Progression-free survival is defined as the time from registration to disease progression or death, whichever occurs first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Assessed every 12 weeks up to 36 months|all participants||months||95% Confidence Interval|Median
674721|NCT01646021|Secondary|One Year Survival Rate|One ­year survival rate, defined as the proportion of participants who were alive 1 year after randomization.|Month 12|The Intent ­to ­Treat population included all participants randomized into the study.||Proportion of participants||95% Confidence Interval|Number
674441|NCT01648920|Primary|FeNO Values by Smoking Status: FeNO >= 50ppb|"Fractional Exhaled Nitric Oxide (FeNO) measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests were compared against final asthma diagnosis. Data are presented for participants with FeNO >=50ppb who either did not smoke previously or are current smokers."|approximately 1-hour|||participants|||Number
674442|NCT01648920|Primary|FeNO Values by Smoking Status: FeNO >= 25ppb to <= 50ppb|"Fractional Exhaled Nitric Oxide (FeNO) measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests were compared against final asthma diagnosis. Data are presented for participants with FeNO >=25ppb to <=50ppb who either did not smoke previously or are current smokers."|approximately 1-hour|||participants|||Number
674443|NCT01648920|Primary|FeNO Values by Smoking Status: FeNO <25ppb|"Fractional Exhaled Nitric Oxide (FeNO) measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests were compared against final asthma diagnosis. Data are presented for participants with FeNO <25ppb who either did not smoke previously or are current smokers."|approximately 1-hour|||participants|||Number
674444|NCT01648920|Primary|FeNO Values by ICS Use: FeNO >= 25ppb to <= 50ppb|"Fractional Exhaled Nitric Oxide (FeNO) measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests were compared against final asthma diagnosis. Data are presented for participants with FeNO <=25ppb to <=50ppb who either did not use Inhaled Corticosteroids (ICS) or did use Inhaled Corticosteroids."|approximately 1-hour|||participants|||Number
674445|NCT01648920|Primary|FeNO Values by ICS Use: FeNO >= 50ppb|"Fractional Exhaled Nitric Oxide (FeNO) measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests were compared against final asthma diagnosis. Data are presented for participants with FeNO >=50ppb who either did not use Inhaled Corticosteroids (ICS) or did use Inhaled Corticosteroids."|approximately 1-hour|||participants|||Number
674446|NCT01648920|Primary|FeNO Values by ICS Use: FeNO <25ppb|"Fractional Exhaled Nitric Oxide (FeNO) measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests were compared against final asthma diagnosis. Data are presented for participants with FeNO <25ppb who either did not use Inhaled Corticosteroids (ICS) or did use Inhaled Corticosteroids."|approximately 1-hour|||participants|||Number
674447|NCT01648920|Primary|Negative Predictive Value (%) for FeNO|"Fractional Exhaled Nitric Oxide (FeNO) measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis. Negative predictive value is a way of saying the likelihood of a negative test means you do not have disease. In this study it is defined as the percentage of study participants with a low FeNO who do not have asthma."|approximately 1-hour|||percent|||Number
674448|NCT01648920|Primary|Positive Predictive Value (%) for FeNO|"Fractional Exhaled Nitric Oxide (FeNO) measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis. Positive predictive value is a way of saying the likelihood a positive test means you have a disease. In this study, it is defined as the percentage of study participants with a high FeNO who have asthma."|approximately 1-hour|||percent|||Number
674449|NCT01648920|Primary|Specificity (%) for FeNO|"Fractional Exhaled Nitric Oxide (FeNO) measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis. Specificity is a way of saying how likely a test is negative if you do not have a disease and is expressed as (%) percent. For this study, specificity was the ability of FeNO to correctly identify a study participant who does not have asthma."|approximately 1-hour|||percent|||Number
674450|NCT01648920|Primary|Sensitivity (%) for FeNO|"Fractional Exhaled Nitric Oxide (FeNO) measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis. Sensitivity is a way of saying how likely a test is positive if you have a disease and is expressed as (%) percent. For this study, sensitivity was the ability of FeNO to correctly identify a study participant who has asthma."|approximately 1-hour|||percent|||Number
674451|NCT01648920|Primary|Asthma Diagnosis by FeNO: Mean FeNO Value|"Fractional Exhaled Nitric Oxide (FeNO) measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis."|approximately 1-hour|||Parts per billion (ppb)||Standard Deviation|Mean
675792|NCT01634854|Primary|Time From Induction to Vaginal Delivery|Comparing the time to delivery in multiparas undergoing induction of labor with vaginal misoprostol or intravenous oxytocin.|Time to delivery in minutes from initiation of medication, up to 24 hours|||minutes||Inter-Quartile Range|Median
674452|NCT01648920|Primary|Asthma Diagnosis by FeNO: FeNO >50ppb|"Fractional Exhaled Nitric Oxide (FeNO) measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis."|approximately 1-hour|||participants|||Number
674453|NCT01648920|Primary|Asthma Diagnosis by FeNO: FeNO >=25ppb to <= 50ppb|"Fractional Exhaled Nitric Oxide (FeNO) measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis."|approximately 1-hour|||participants|||Number
674454|NCT01648920|Primary|Asthma Diagnosis by FeNO: FeNO <25ppb|"Fractional Exhaled Nitric Oxide (FeNO) measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis."|approximately 1-hour|||participants|||Number
674455|NCT01648920|Primary|Asthma Diagnosis by MCC Results: Negative MCC Response|"Fractional Exhaled Nitric Oxide (FeNO) measurements was performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis. A negative response to methacholine challenge is defined as a less than 20% decrease in FEV1 at a methacholine dose less than or equal to 16mg/ml from baseline."|approximately 1-hour|||participants|||Number
674456|NCT01648920|Primary|Asthma Diagnosis by MCC Results: Positive MCC Response|"Fractional Exhaled Nitric Oxide (FeNO) measurements was performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis. A positive response to methacholine challenge is defined as a greater than or equal to 20% decrease in FEV1 at a methacholine dose less than or equal to 16mg/ml from baseline in response to methacholine."|approximately 1-hour|||participants|||Number
674457|NCT01648920|Primary|FeNO by Methacholine Challenge (MCC) Results: FeNO >50ppb|"Fractional Exhaled Nitric Oxide (FeNO) measurements will be performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests will be performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis. A positive response to methacholine challenge is defined as a greater than or equal to 20% decrease in FEV1 at a methacholine dose less than or equal to 16mg/ml from baseline in response to methacholine. A negative response to methacholine challenge is defined as a less than 20% decrease in FEV1 at a methacholine dose less than or equal to 16mg/ml from baseline."|approximately 1-hour|Participants with FeNO >50ppb||participants|||Number
674458|NCT01648920|Primary|FeNO by Methacholine Challenge (MCC) Results: FeNO >=25ppb to <=50ppb|"Fractional Exhaled Nitric Oxide (FeNO) measurements will be performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests will be performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis. A positive response to methacholine challenge is defined as a greater than or equal to 20% decrease in FEV1 at a methacholine dose less than or equal to 16mg/ml from baseline in response to methacholine. A negative response to methacholine challenge is defined as a less than 20% decrease in FEV1 at a methacholine dose less than or equal to 16mg/ml from baseline."|approximately 1-hour|Participants with FeNO >= 25 ppb to <= 50 ppb||participants|||Number
674459|NCT01648920|Primary|FeNO by Methacholine Challenge (MCC) Results: FeNO <25ppb|"Fractional Exhaled Nitric Oxide (FeNO) measurements will be performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests will be performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis. A positive response to methacholine challenge is defined as a greater than or equal to 20% decrease in FEV1 at a methacholine dose less than or equal to 16mg/ml from baseline in response to methacholine. A negative response to methacholine challenge is defined as a less than 20% decrease in FEV1 at a methacholine dose less than or equal to 16mg/ml from baseline."|approximately 1-hour|Participants with a FeNO < 25 ppb||participants|||Number
674460|NCT01648920|Primary|Mean FeNO Levels by Methacholine Challenge (MCC) Results: MCC Results|"Fractional Exhaled Nitric Oxide (FeNO) measurements will be performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests will be performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis."|approximately 1-hour|||parts per billion (ppb)||Standard Deviation|Mean
674461|NCT01648920|Primary|Methacholine Challenge (MCC) Results|"Fractional Exhaled Nitric Oxide (FeNO) measurements will be performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests will be performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis."|approximately 1-hour|||participants|||Number
674462|NCT01648790|Secondary|Pharmacokinetics: Area Under the Concentration Curve (AUC) of Prasugrel Test Formulation in Fasted and Fed State|AUC(0-tlast) = area under the concentration versus time curve from time zero to time t, where t is the last time point with a measurable concentration. Test formulation is defined as the orally disintegrating tablet containing Magnasweet® (ODT2) specific to the 5 mg prasugrel dosing in the fasted and fed state. Pharmacokinetics will measure prasugrel's active metabolite.|Predose through 8 Hours Post Dose|Pharmacokinetic population consists of all participants who received at least one dose of study drug and have evaluable pharmacokinetic data.||nanograms*hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
674463|NCT01648790|Secondary|Pharmacokinetics: Maximum Concentration (Cmax) of Prasugrel Test Formulation in Fasted and Fed State|Cmax= maximum concentration measured from predose through 8 hours postdose. Test formulation is defined as the orally disintegrating tablet containing Magnasweet® (ODT2) specific to the 5 mg prasugrel dosing in the fasted and fed state. Pharmacokinetics will measure prasugrel's active metabolite.|Predose through 8 Hours Post Dose|Pharmacokinetic population consists of all participants who received at least one dose of study drug and have evaluable pharmacokinetic data.||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
674464|NCT01648790|Primary|Pharmacokinetics: Area Under the Concentration Curve (AUC) of Prasugrel Reference and Test Formulation|AUC(0-tlast) = area under the concentration versus time curve from time zero to time t, where t is the last time point with a measurable concentration. Test formulation is defined as the orally disintegrating tablet containing Magnasweet® (ODT2) and the reference formulation is defined as the orally disintegrating tablet without Magnasweet® (ODT1) specific to the 5 mg prasugrel dosing. Pharmacokinetics will measure prasugrel's active metabolite.|Predose through 8 Hours Post Dose|Pharmacokinetic population consists of all participants who received at least one dose of study drug and have evaluable pharmacokinetic data.||nanograms*hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
674465|NCT01648790|Primary|Pharmacokinetics: Maximum Concentration (Cmax) of Prasugrel Test and Reference Formulation|Cmax= maximum concentration measured from predose through 8 hours postdose. Test formulation is defined as the orally disintegrating tablet containing Magnasweet® (ODT2) and the reference formulation is defined as the orally disintegrating tablet without Magnasweet® (ODT1) specific to the 5 milligrams (mg) prasugrel dosing. Pharmacokinetics will measure prasugrel's (LY640315) active metabolite.|Predose through 8 Hours Post Dose|Pharmacokinetic population consists of all participants who received at least one dose of study drug and have evaluable pharmacokinetic data.||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
674466|NCT01648699|Secondary|Number of Participants With Categorical Score on Clinical Global Impression Scale as Assessed by Clinician|"The Clinical Global Impression (CGI) rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant, which ranges from very much worse to very much improved (as compared to Baseline)."|Day 28|"ITT population included all participants who received at least one dose of study medication at Baseline. n signifies those participants who were evaluated for this measure at the specified time point. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure."||Participants|||Number
674467|NCT01648699|Secondary|Number of Participants Given Rescue Pain Medications|Rescue medication was a medication intended to relieve symptoms immediately. Rescue medication of morphine was used during the study duration and dose was set at 10-15 percent of the total daily morphine dose which ranged from 10-60 milligram.|Day 28|ITT population included all participants who received at least one dose of study medication at Baseline. 'N ' (number of participants analyzed) signifies the participants evaluable for this measure.||Participants|||Number
674468|NCT01648699|Primary|Brief Pain Inventory (BPI) Average Score at Day 28|The BPI assesses the severity of pain and the impact of pain on daily functions (interference items). The severity items are scored from 0=no pain and 10=pain as bad as you can imagine. The interference items are scored from 0=no interference and 10=interferes completely.|Day 28|ITT population included all participants who received at least one dose of study medication at Baseline. 'N ' (number of participants analyzed) signifies the participants evaluable for this measure.||Units on a scale||Standard Deviation|Mean
674469|NCT01648699|Primary|Brief Pain Inventory (BPI) Average Score at Baseline|The Brief Pain Inventory (BPI) assesses the severity of pain and the impact of pain on daily functions (interference items). The severity items are scored from 0=no pain and 10=pain as bad as you can imagine. The interference items are scored from 0=no interference and 10=interferes completely.|Baseline|Intent-to-treat (ITT) population included all participants who received at least one dose of study medication at Baseline.||Units on a scale||Standard Deviation|Mean
674470|NCT01648582|Secondary|Change From Baseline in EQ-5D Visual Analog Scale Score|The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument. Overall health state score was self-reported using a visual analogue scale (VAS) marked on a scale of 0 to 100 with 0 representing worst imaginable health state and 100 representing best imaginable health state. LS means of change from baseline were calculated using ANCOVA and adjusted by treatment, country, and baseline.|Baseline, 26 weeks, 52 weeks|Participants who were randomized, received at least one dose of study drug, and had evaluable HbA1c data at both baseline and post-baseline.||units on a scale||Standard Deviation|Mean
674471|NCT01648582|Secondary|EQ-5D Health State Score Responses|The EQ-5D questionnaire is a widely used, generic questionnaire that assesses health-related quality of life. It consists of 2 parts. The first part assesses 5 dimensions associated with quality of life (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension has 3 possible levels of response: no problem, some problem, and extreme problem. Additional categories of response include ambiguous and missing. The number of participants per each of the 3 response categories is summarized for each of the 5 dimensions.|Baseline, 26 Weeks, 52 Weeks|Participants who were randomized, received at least one dose of study drug, and had evaluable HbA1c data at both baseline and post-baseline.||participants|||Number
674472|NCT01648582|Secondary|Percentages of Participants Developing Treatment-Emergent Dulaglutide Anti-drug Antibody (ADA)|Number of participants with treatment emergent (TE) dulaglutide anti-drug antibodies from postbaseline to follow up were summarized. A participant was considered to have TE dulaglutide ADA if the participant had at least one titer that was treatment-emergent relative to baseline, defined as a 4-fold or greater increase in titer from baseline measurement.|Baseline through 52 Weeks|Participants in the safety population who were randomized and received at least one dose of study drug.||Percentage of participants|||Number
674473|NCT01648582|Secondary|Change in Body Mass Index|Body mass index is an estimate of body fat based on body weight divided by height squared.|Baseline, 26 Weeks, 52 Weeks|Participants in the safety population who were randomized and received at least one dose of study drug.||kilogram/square meter (kg/m2)||Standard Error|Least Squares Mean
674474|NCT01648582|Secondary|Change From Baseline in Body Weight||Baseline, 26 Weeks, 52 Weeks|Participants in the safety population who were randomized and received at least one dose of study drug.||kilogram (kg)||Standard Error|Least Squares Mean
674475|NCT01648582|Secondary|Number of Participants With Adjudicated Pancreatitis|The number of participants with pancreatitis confirmed by adjudication is summarized. Events of pancreatitis (including suspected pancreatitis and severe or serious abdominal pain) were adjudicated by a committee of expert physicians external to the Sponsor. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 52 Weeks|Participants in the safety population who were randomized and received at least one dose of study drug.||participants|||Number
674476|NCT01648582|Secondary|Number of Participants With Adjudicated Cardiovascular (CV) Events|Deaths and nonfatal cardiovascular adverse events were adjudicated by a committee of physicians with cardiology expertise external to the Sponsor. The nonfatal cardiovascular events subjected to adjudication included myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions (such as coronary artery bypass graft or percutaneous coronary intervention), and cerebrovascular events including cerebrovascular accident (stroke) and transient ischemic attack. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 52 weeks|Participants in the safety population who were randomized and received at least one dose of study drug.||participants with adjudicated CV events|||Number
674477|NCT01648582|Secondary|Change From Baseline in Serum Calcitonin||Baseline, 26 Weeks, 52 Weeks|Participants in the safety population who were randomized and received at least one dose of study drug. Only pre-rescue measurements were used. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||picomole/liter||Standard Deviation|Mean
674478|NCT01648582|Secondary|Change From Baseline in Pancreatic Enzymes|Amylase (total and pancreas-derived) and lipase concentrations were measured|Baseline, 26 Weeks, 52 Weeks|Participants in the safety population who were randomized and received at least one dose of study drug. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||Units/Liter (U/L)||Standard Deviation|Mean
674479|NCT01648582|Secondary|Change From Baseline in Electrocardiogram Parameters, Heart Rate (HR)||Baseline, 26 Weeks, 52 Weeks|Participants in the safety population who were randomized and received at least one dose of study drug.||beats per minute (bpm)||Standard Deviation|Mean
674480|NCT01648582|Secondary|Change From Baseline in Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. PR is the interval between the P wave and the QRS complex.|Baseline, 26 Weeks, 52 Weeks|Participants in the safety population who were randomized and received at least one dose of study drug.||millisecond (msec)||Standard Deviation|Mean
674481|NCT01648582|Secondary|Change From Baseline at 26 Weeks and 52 Weeks on Pulse Rate|Seated pulse rate was measured. LS means of change from baseline were calculated using a MMRM with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26 Weeks, 52 Weeks|Participants in the safety population who were randomized and received at least one dose of study drug.||beats per minute (bpm)||Standard Error|Least Squares Mean
674482|NCT01648582|Secondary|Change From Baseline to 26 Weeks and 52 Weeks on Blood Pressure (BP)|Seated systolic blood pressure (SBP) and seated diastolic blood pressure (DBP) were measured. LS means of change from baseline were calculated using a MMRM with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26 Weeks, 52 Weeks|Participants in the safety population who were randomized and received at least one dose of study drug.||millimeters of mercury (mmHg)]||Standard Error|Least Squares Mean
674483|NCT01648582|Secondary|Number of Self-reported Hypoglycemic Events|Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant felt that he/she was experiencing symptoms and/or signs associated with hypoglycemia, and had a plasma glucose level of less than or equal to 3.9 millimoles/liter [mmol/L]), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of less than or equal to 3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The number of self-reported hypoglycemic events was summarized cumulatively at 52 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 Weeks and 52 Weeks|Participants in the safety population who were randomized and received at least one dose of study drug.||percentage of participants|||Number
674484|NCT01648582|Secondary|Rate of Hypoglycemic Events|Hypoglycemic events (HE) were classified as documented symptomatic hypoglycemia, asymptomatic hypoglycemia, severe hypoglycemia, and probable symptomatic hypoglycemia. The 1-year adjusted rate of HEs was summarized cumulatively at 26 weeks and 52 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 weeks and 52 weeks|Participants in the safety population who were randomized and received at least one dose of study drug.||events per participant per year||Standard Deviation|Mean
674485|NCT01648582|Secondary|Change From Baseline in Homeostasis Model Assessment 2 Insulin Sensitivity - Cell Function (HOMA2-%S) at 26 Weeks and 52 Weeks|The HOMA2 was used to estimate the steady-state insulin sensitivity (%S). HOMA2-S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S) as a percentage of the normal reference population. LS means were calculated using an homeostasis model assessment with change from baseline in HOMA-%S as a covariate and country, baseline measurement, OAM, and treatment as fixed effects.|Baseline, 26 Weeks, 52 Weeks|Participants who were randomized, received at least one dose of study drug, and had evaluable HbA1c data at both baseline and post-baseline. Missing endpoints were imputed with the LOCF method. HOMA2 was not evaluated for insulin glargine, as the use of this model has not been validated in participants treated with insulin.||percentage of HOMA2-%S||Standard Error|Least Squares Mean
674722|NCT01646021|Secondary|Overall Survival (OS)|Overall survival (OS), defined as the duration (months) from the date of randomization to the date of the participant’s death from any cause.|Approximately 28.2 months|The Intent ­to­ Treat population included all participants randomized into the study.||Months||95% Confidence Interval|Median
674486|NCT01648582|Secondary|Change From Baseline in Homeostasis Model Assessment 2 Steady-state Beta (β)- Cell Function (HOMA2-%B) at 26 Weeks and 52 Weeks|The updated Homeostasis Model Assessment (HOMA2) was used to quantify steady state beta-cell function (%B). HOMA2-%B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate %B as a percentage of a normal reference population. LS means were calculated using a homeostasis model assessment with change from baseline in HOMA-%B as a covariate and country, baseline measurement, OAM, and treatment as fixed effects.|Baseline, 26 weeks, 52 weeks|Participants who were randomized, received at least one dose of study drug, and had evaluable HbA1c data at both baseline and post-baseline. Missing endpoints were imputed with the LOCF method. HOMA2 was not evaluated for insulin glargine, as the use of this model has not been validated in participants treated with insulin.||percentage of HOMA2-%B||Standard Error|Least Squares Mean
674487|NCT01648582|Secondary|Change From Baseline in 7-point Self-monitored Blood Glucose (SMBG) Profiles at 26 Weeks and 52 Weeks|Participants were required to perform 7-point SMBG profiles on 2 separate, nonconsecutive days during the 2 weeks before randomization and Weeks 8, 14, 20, 26, 39, and 52 (or the Early Discontinuation Visit). SMBG measurements were taken using a plasma-equivalent blood glucose (BG) meter at 7 time points: morning pre-meal, morning 2 hours post-meal, mid-day pre-meal, mid-day 2 hours post-meal, evening pre-meal, evening 2 hours post-meal, and at bedtime. Mean and Week 26 and Week 52 was assessed in all treatment groups. LS means of change from baseline were calculated using MMRM with the change in 7-point SMBG as the dependent variable and treatment, baseline value, country, OAM, visit, and treatment-by-visit interaction as fixed effects, and participant was the random effect.|Baseline, 26 Weeks, 52 Weeks|Participants who were randomized, received at least one dose of study drug, and had evaluable HbA1c data at both baseline and post-baseline.||mmol/L||Standard Error|Least Squares Mean
674488|NCT01648582|Secondary|Change From Baseline in Fasting Blood Glucose (FBG) at 26 Weeks and 52 Weeks|LS means of change from baseline were calculated using MMRM with the change in FBG as the dependent variable and treatment, baseline value, country, OAM, visit, and treatment-by-visit interaction as fixed effects, and participant was the random effect.|Baseline, 26 Weeks, 52 Weeks|Participants who were randomized, received at least one dose of study drug, and had evaluable HbA1c data at both baseline and post-baseline.||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
674489|NCT01648582|Secondary|Percentage of Participants Attaining HbA1c of <7% or ≤6.5% at 26 Weeks and 52 Weeks|The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100.|Up to 26 and 52 weeks|Participants who were randomized, received at least one dose of study drug, and had evaluable HbA1c data at both baseline and post-baseline. Missing endpoints were imputed with the last observation carried forward (LOCF) method.||percentage of participants|||Number
674490|NCT01648582|Secondary|Change From Baseline in HbA1c at 52 Weeks|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. LS means of change from baseline in HbA1c were calculated using a MMRM with the change in HbA1c as the dependent variable and treatment, baseline HbA1c, country, OAM, visit, and treatment-by-visit interaction as fixed effects, and participant was as the random effect.|Baseline, 52 Weeks|Participants who were randomized, received at least one dose of study drug, and had evaluable HbA1c data at both baseline and post-baseline.||percentage of HbA1c||Standard Error|Least Squares Mean
674491|NCT01648582|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 26 Weeks|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least square (LS) means of change from baseline in HbA1c were calculated using a mixed-effects model for repeated measures (MMRM) with the change in HbA1c as the dependent variable and treatment, baseline HbA1c, country, oral antihyperglycemic medication (OAM) , visit, and treatment-by-visit interaction as fixed effects, and participant was the random effect.|Baseline, 26 Weeks|Participants who were randomized, received at least one dose of study drug, and had evaluable HbA1c data at both baseline and post-baseline.||percentage of HbA1c||Standard Error|Least Squares Mean
674492|NCT01648530|Primary|Migraine Disability Assessment (MIDAS)|The Midas score is a patient completed 5-item questionnaire about lost time and productivity (for work, school or family/social activities) in the past 3 months (number of days missed) where: 0-5=Little or No disability, 6-10=Mild disability, 11-20=Moderate disability or 21+ Severe disability. The Midas scores assessed at Months 3, 6, 9 and 12 were averaged.|12 Months|All qualified participants at Baseline who returned completed survey with positive screening for migraines.||days||Standard Deviation|Mean
674493|NCT01648530|Primary|Percentage of Participants With Episodic Migraine (EM) or Chronic Migraine (CM)|EM is defined as <15 headache days/month and CM is defined as ≥15 headache days/month.|Baseline|All qualified participants at Baseline who returned completed survey with positive screening for migraines.||percentage of participants|||Number
674494|NCT01648491|Secondary|Quality of Life (QOL) Described by the Patient's Response on the Patient Global Impression of Improvement (PGI-I)|The PGI-I is a global index used to rate the response of a condition to a therapy. The patient's response describes their current condition compared to before they were treated. Responses are: 1 Very Much Better, 2 Much Better, 3 A Little Better, 4 No Change, 5 A Little Worse, 6 Much Worse, and 7 Very Much Worse.|6 months|||units on a scale|||Number
674495|NCT01648491|Secondary|Quality of Life (QOL) Described by the Patient's Response on the Global Response Assessment (GRA)|The GRA measures overall improvement with therapy. The patient's response describes their current condition compared to before they were treated. Responses are: 1 Markedly Improved, 2 Moderately Improved, 3 Slightly Improved, 4 No Change, 5 Slightly Worse, 6 Moderately Worse, and 7 Markedly Worse.|6 months|||units on a scale|||Number
674496|NCT01648491|Secondary|Quality of Life (QOL) Described by the Patient's Response on the Patient Global Assessment of Severity (PGI-S) Questionnaire|"The PGI-S is comprised of two questions. Question 1 asks the patient to describe how their urinary tract condition is now. Responses are 1 Normal, 2 Mild, 3 Moderate and 4 Severe. Question 2 asks the patient If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that? Responses are 1 Delighted, 2 Pleased, 3 Mostly Satisfied, 4 Mixed, 5 Mostly Dissatisfied, 6 Unhappy and 7 Terrible."|Baseline and 6 months|||units on a scale|||Number
674497|NCT01648491|Primary|Study-Related Adverse Events||6 months|||Adverse Events|||Number
675819|NCT01634256|Secondary|Changes in AST(Aspartate Transaminase)|AST was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis||IU/L||Standard Deviation|Mean
674498|NCT01648452|Secondary|Number of Participants Who Experienced an Improvement in Color Discrimination and/or Matching Post-Implantation in the Untreated Control Eye.|Color hue discrimination was tested by the Nagel anomaloscope, American Optical Hardy Rand Rittler (AOHRR) color plates, and a low vision version of the Cambridge Color Test (LvCCT) implemented on a ViSaGe System (Cambridge Research Systems Ltd., Rochester, UK) using custom-written software. Hardy Rand Rittler testing followed the guidelines accompanying the test and administered under a Macbeth Lamp at 300 lux.|Day 1, Week 1, Week 4, Week 12, Week 24, Week 52, Week 78, Week 156 post-implantation|||participants|||Number
674499|NCT01648452|Secondary|Number of Participants Who Experienced an Improvement in Color Discrimination and/or Matching Post-Implantation in the Study Eye.|Color hue discrimination was tested by the Nagel anomaloscope, American Optical Hardy Rand Rittler (AOHRR) color plates, and a low vision version of the Cambridge Color Test (LvCCT) implemented on a ViSaGe System (Cambridge Research Systems Ltd., Rochester, UK) using custom-written software. Hardy Rand Rittler testing followed the guidelines accompanying the test and administered under a Macbeth Lamp at 300 lux.|Day 1, Week 1, Week 4, Week 12, Week 24, Week 52, Week 78, Week 156 post-implantation|||participants|||Number
674500|NCT01648452|Secondary|Number of Participants Who Experienced an Increase in Either the Rod or Cone Electroretinogram (ERG) Responses of More Than 75% Post-Implantation in the Untreated Control Eye.|Full-ﬁeld ERGs were recorded according to International Society of Clinical Electrophysiology of Vision Standards (ISCEV).|Day 1, Week 1, Week 4, Week 12, Week 24, Week 52, Week 78, Week 156 post-implantation|||participants|||Number
674501|NCT01648452|Secondary|Number of Participants Who Experienced an Increase in Either the Rod or Cone Electroretinogram (ERG) Responses of More Than 75% Post-Implantation in the Study Eye.|Full-ﬁeld ERGs were recorded according to International Society of Clinical Electrophysiology of Vision Standards (ISCEV).|Day 1, Week 1, Week 4, Week 12, Week 24, Week 52, Week 78, Week 156 post-implantation|||participants|||Number
674502|NCT01648452|Secondary|Number of Participants Who Experienced an Improvement in Visual Acuity of Greater Than 0.3 logMAR (Logarithm of the Minimum Angle of Resolution) Post-Implantation in the Untreated Control Eye.|"Improvement of visual acuity was assessed on both the study and control eyes. Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20. .
The LogMAR scale [expressed as the (decadic) logarithm of the minimum angle of resolution (range from +1.00 to -0.30)] converts the geometric sequence of a traditional chart to a linear scale. It measures VA loss; positive values indicate vision loss, whereas negative values denote normal or better VA. A lower LogMAR value indicates better VA. For example, a visual acuity of 20/20 corresponds to a logMAR value of zero (0), and a visual acuity of 20/100 corresponds to a LogMAR value of 0.7."|Day 1, Week 1, Week 4, Week 12, Week 24, Week 52, Week 78, Week 156 post-implantation|||participants|||Number
674503|NCT01648452|Secondary|Number of Participants Who Experienced an Improvement in Visual Acuity of Greater Than 0.3 logMAR (Logarithm of the Minimum Angle of Resolution) Post-Implantation in the Study Eye.|"Improvement of visual acuity was assessed on both the study and control eyes. Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20. .
The LogMAR scale [expressed as the (decadic) logarithm of the minimum angle of resolution (range from +1.00 to -0.30)] converts the geometric sequence of a traditional chart to a linear scale. It measures VA loss; positive values indicate vision loss, whereas negative values denote normal or better VA. A lower LogMAR value indicates better VA. For example, a visual acuity of 20/20 corresponds to a logMAR value of zero (0), and a visual acuity of 20/100 corresponds to a LogMAR value of 0.7."|Day 1, Week 1, Week 4, Week 12, Week 24, Week 52, Week 78, Week 156 post-implantation|||participants|||Number
674504|NCT01648452|Secondary|Number of Non-Ocular Adverse Events at All Time Points Post-Implantation|The total number of non eye-related adverse events reported from Day 1 post-implantation through study completion at Year 3.|Day 1, Week 1, Week 4, Week 12, Week 24, Week 52, Week 78, Week 156 post-implantation|||Adverse Events|||Number
674505|NCT01648452|Secondary|Number of Ocular Adverse Events at All Time Points Post-Implantation|The total number of eye-related adverse events reported from Day 1 post-implantation through study completion at Year 3.|Day 1, Week 1, Week 4, Week 12, Week 24, Week 52, Week 78, Week 156 post-implantation|||Adverse Events|||Number
674506|NCT01648452|Secondary|Number of Severe Adverse Events at All Time Points Post-Implantation|"The total number of severe adverse events reported from Day 1 post-implantation through study completion at Year 3.
Although there were two serious adverse events (SAEs) reported during the study, only one event's severity was classified as severe."|Day 1, Week 1, Week 4, Week 12, Week 24, Week 52, Week 78, Week 156 post-implantation|||Adverse Events|||Number
674507|NCT01648452|Secondary|Number of Adverse Events at All Time Points Post-Implantation|The total number of adverse events reported from Day 1 post-implantation through study completion at Year 3.|Day 1, Week 1, Week 4, Week 12, Week 24, Week 52, Week 78, Week 156 post-implantation|||Adverse Events|||Number
674508|NCT01648452|Primary|Number of Non-Ocular Adverse Events at Six Months Post-Implantation|The number of non eye-related adverse events reported within six months post-implantation.|Day 1, Week 1, Week 4, Week 12, Week 24 post-implantation|||Adverse Events|||Number
674509|NCT01648452|Primary|Number of Ocular Adverse Events at Six Months Post-Implantation|The number of eye-related adverse events reported within six months post-implantation.|Day 1, Week 1, Week 4, Week 12, Week 24 post-implantation|||Adverse Events|||Number
674510|NCT01648452|Primary|Number of Severe Adverse Events at Six Months Post-Implantation|The number of severe adverse events reported within six months post-implantation.|Day 1, Week 1, Week 4, Week 12, Week 24 post-implantation|||Adverse Events|||Number
674511|NCT01648452|Primary|Number of Adverse Events at Six Months Post-Implantation|The primary outcome is the total number of adverse events reported within six months post-implantation.|Day 1, Week 1, Week 4, Week 12, Week 24 post-implantation|||Adverse Events|||Number
674753|NCT01645059|Secondary|Adjuvant Treatment-Physical Activity|"Adjuvant treatment and clinical profile (Physical activity)
The patients analysed in this outcome are patients initially diagnosed with localized breast cáncer (N=66)"|one day (there is no follow-up, it is a cross-sectional study)|||percentage of patients physical activity|||Number
674512|NCT01648140|Secondary|Correlation GSK2336805 Pre-dose Plasma Concentration on Day 2 Versus Reduction in HCV RNA on Day 2|Correlation GSK2336805 pre-dose plasma concentration (ng/mL) on Day 2 versus reduction in HCV RNA (log IU/mL) on Day 2 was performed. As defined in the RAP for this protocol, correlations between GSK2336805 dose, and selected PK parameters and virological outcomes was analyzed only with graphical presentations to facilitate clinical interpretation and data summarization. These data were also provided in by-participant data listings. Therefore, no statistical summary tables are available.|Day 2|PK/PD Analysis Population|||||
674513|NCT01648140|Secondary|Correlation of Individual GSK2336805 Dose With Pre-dose Plasma Concentration at Week 4 and Week 12 Versus eRVR Status|Correlation of individual GSK2336805 dose with pre-dose plasma concentration at Week 4 and Week 12 versus eRVR status was performed. eRVR is defined as plasma HCV RNA <LLOQ and target not detected at Weeks 4 and 12. The PK/Pharmacodynamic (PD) analysis population comprised of all participants with available PD measures (e.g., safety and/or efficacy data) and with evaluable GSK2336805 plasma concentration data considered suitable for investigation of relationship with the PD measures. As defined in the RAP for this protocol, correlations between GSK2336805 dose, and selected PK parameters and virological outcomes was analyzed only with graphical presentations to facilitate clinical interpretation and data summarization. These data were also provided in by-participant data listings. Therefore, no statistical summary tables are available.|Week 4 and Week 12|PK/PD Analysis Population|||||
674514|NCT01648140|Secondary|Correlation of Individual GSK2336805 Dose With Week 4 Plasma Cmax, Ctau, C0 Versus RVR Status|Correlation of Individual GSK2336805 40 mg and 60 mg dose with Week 4 maximum plasma concentration (Cmax), pre-dose concentration (C0), concentration at the end of the dosing interval (Ctau) versus RVR status (RVR and no RVR) was performed. RVR is defined as plasma HCV RNA <LLOQ and target not detected 4 weeks after initiation of therapy. As defined in the RAP for this protocol, correlations between GSK2336805 dose, and selected PK parameters and virological outcomes was analyzed only with graphical presentations to facilitate clinical interpretation and data summarization. These data were also provided in by-participant data listings. Therefore, no statistical summary tables are available.|Week 4|Intensive PK Population|||||
674515|NCT01648140|Secondary|Correlation of Individual GSK2336805 Dose With Week 4 Plasma AUC(0-tau) Versus RVR Status|Correlation of individual GSK2336805 40 mg and 60 mg with Week 4 plasma AUC(0-tau) versus eRVR Status (RVR and no eVE) was performed. RVR is defined as plasma HCV RNA <LLOQ and target not detected 4 weeks after initiation of therapy. AUC (0-tau) is area under the concentration-time curve over the dosing interval. As defined in the RAP for this protocol, correlations between GSK2336805 dose, and selected PK parameters and virological outcomes was analyzed only with graphical presentations to facilitate clinical interpretation and data summarization. These data were also provided in by-participant data listings. Therefore, no statistical summary tables are available.|Week 4|Intensive PK Population|||||
674516|NCT01648140|Secondary|Correlation of Individual GSK2336805 Dose With Week 4 Plasma Cmax, Ctau, C0 Versus eRVR Status|Correlation of Individual GSK2336805 40 mg and 60 mg dose with Week 4 maximum plasma concentration (Cmax), pre-dose concentration (C0), concentration at the end of the dosing interval (Ctau) versus eRVR status (eRVR and no eRVR) was performed. eRVR is defined as plasma HCV RNA <LLOQ and target not detected at Weeks 4 and 12. As defined in the RAP for this protocol, correlations between GSK2336805 dose, and selected PK parameters and virological outcomes was analyzed only with graphical presentations to facilitate clinical interpretation and data summarization. These data were also provided in by-participant data listings. Therefore, no statistical summary tables are available.|Week 4 and Week 12|Intensive PK Population|||||
674517|NCT01648140|Secondary|Correlation of Individual GSK2336805 Dose With Week 4 Plasma AUC(0-tau) Versus eRVR Status|Correlation of individual GSK2336805 40 mg and 60 mg with Week 4 plasma AUC(0-tau) versus eRVR Status (eRVR and no eRVE) was performed. eRVR is defined as plasma HCV RNA <LLOQ and target not detected at Weeks 4 and 12. AUC (0-tau) is area under the concentration-time curve over the dosing interval. As defined in the RAP for this protocol, correlations between GSK2336805 dose, and selected pharmacokinetic parameters and virological outcomes was analyzed only with graphical presentations to facilitate clinical interpretation and data summarization. These data were also provided in by-participant data listings. Therefore, no statistical summary tables are available.|Week 4 and Week 12|Intensive PK Population|||||
674518|NCT01648140|Secondary|Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points After Week 12|Blood samples were collected for the measurement of estimated creatinine clearance by Cockcroft-Gault formula at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the estimated creatinine clearance values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.||mL/min||Standard Deviation|Mean
674519|NCT01648140|Secondary|Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12|Blood samples were collected for the measurement of Chloride, bicarbonate, glucose, potassium, sodium, inorganic phosphorus and urea/bun at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Bun values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last pre-treatment value observed.|Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.||Millimoles per liter||Standard Deviation|Mean
674520|NCT01648140|Secondary|Mean Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QTcB, QTcF Values at the Indicated Time Points After Week 12|The ECG data was only collected “Perform as needed”, therefore, no such summary table was generated. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4|Safety Population|||||
674522|NCT01648140|Secondary|Mean Change From Baseline in Heart Rate at the Indicated Time Points After Week 12|Vital sign monitoring included heart rate, measured at the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. As defined in the Reporting Analysis Plan (RAP) for this protocol, the supplemental final data package generated for this study after Week 12 only provided graphical displays of vital signs (e.g., change from Baseline for heart rate and blood pressure) to facilitate clinical interpretation and data summarization. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. All abnormal values and statistical summary tables were not available after week 12.|Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4|Safety Population|||||
674523|NCT01648140|Secondary|Mean Change From Baseline in SBP and DBP at the Indicated Time Points After Week 12|Blood pressure measurements were taken to observe vital signs and included SBP and DBP at the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. As defined in the Reporting Analysis Plan (RAP) for this protocol, the supplemental final data package generated for this study after Week 12 only provided graphical displays of vital signs (e.g., change from baseline for heart rate and blood pressure) to facilitate clinical interpretation and data summarization. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. All abnormal values and statistical summary tables were not available after week 12.|Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4|Safety Population|||||
674524|NCT01648140|Secondary|Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12|Blood samples were collected for the measurement of total bilirubin and creatinine at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the direct bilirubin, total bilirubin and creatinine values are summarized for each post-Baseline assessment afterl Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.||Micromoles per liter||Standard Deviation|Mean
674525|NCT01648140|Secondary|Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12|Blood samples were collected for the measurement of ALP, ALT, AST, CK and GGT at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the ALP, ALT, AST, CK and GGT values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.||International units per liter||Standard Deviation|Mean
674526|NCT01648140|Secondary|Mean Change From Baseline in Albumin at the Indicated Time Points After Week 12|Blood samples were collected for the measurement of albumin at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the albumin values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.||Grams per liter||Standard Deviation|Mean
674527|NCT01648140|Secondary|Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points After Week 12|Blood samples were collected for the measurement of mean corpuscle volume at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the mean corpuscle volume values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.||Femtoliters||Standard Deviation|Mean
674528|NCT01648140|Secondary|Mean Change From Baseline in Hematocrit at the Indicated Time Points After Week 12|Blood samples were collected for the measurement of hematocrit at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the hematocrit values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.||Ratio||Standard Deviation|Mean
674561|NCT01648101|Secondary|Number of Participants Who Were Seizure Free During the MP, ITT Population|"A seizure free-day is defined as a day with non-missing seizure data but without any seizures. A participant was considered to be seizure free during the MP if he/she had no record of countable seizures of any type, no IS, and no SE during the MP. Participants who had one or more days on which they recorded seizures as Not Done on the seizure calendar were not disqualified from being considered as seizure free for that day. Participants who did not complete the study or experienced any seizures in the MP were not considered to be seizure free. A participant who completed the study AND had no seizures during the maintenance phase were counted to be seizure free. Also, a completer who only had seizures during the TiP is considered seizure free."|Baseline; Week 4 up to Week 16|ITT Population.||Participants|||Number
674529|NCT01648140|Secondary|Mean Change From Baseline in Hemoglobin at the Indicated Time Points After Week 12|Blood samples were collected for the measurement of hemoglobin at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the hemoglobin values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4|Safety population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.||Grams per liter||Standard Deviation|Mean
674530|NCT01648140|Secondary|Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points After Week 12|Blood samples were collected for the measurement of red blood cell count at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the red blood cell count values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.||Trillion cells per liter||Standard Deviation|Mean
674531|NCT01648140|Secondary|Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12|Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count and white blood cell count at the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT Week 4. Change from Baseline in the basophils, eosinophils, lymphocytes, total neutrophils platelet count and white blood cell count values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.||Giga cells per liter||Standard Deviation|Mean
674532|NCT01648140|Secondary|Apparent Volume of Distribution (Vz/F) at Week 4|Blood samples for PK analysis of GSK2336805 was obtained on Week 4+1 day at predose and at 1, 2, 4, 7 and 24 hours postdose. Vz/F was calculated as dose divided by (AUC[0-tau] lambda z) where lambda z is the terminal phase rate constant.|Week 4 (24 h post dose)|Intensive PK Summary Population||Liter per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
674533|NCT01648140|Secondary|Apparent Clearance (CL/F) at Week 4|Blood samples for PK analysis of GSK2336805 was obtained on Week 4+1 day at predose and at 1, 2, 4, 7 and 24 hours postdose. CL/F was calculated as dose divided by AUC(0-tau).|Week 4 (24 h post dose)|Intensive PK Summary Population||Liter per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
674534|NCT01648140|Secondary|Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) at Week 4|Blood samples for PK analysis of GSK2336805 was obtained on Week 4+1 day at predose and at 1, 2, 4, 7 and 24 hours postdose.|Week 4 (24 h post dose)|Intensive PK Summary Population||hour*nanogram per milliliter(hr*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
674535|NCT01648140|Secondary|Time of Maximal Plasma Concentration (Tmax) of GSK2336805 at Week 4|Blood samples for PK analysis of GSK2336805 was obtained on Week 4+1 day at predose and at 1, 2, 4, 7, 24 hours postdose.|Week 4 (24 h post dose)|Intensive PK Summary Population||hour||Full Range|Median
674536|NCT01648140|Secondary|Maximum Plasma Concentration (Cmax) and Concentration at the End of the Dosing Interval (Ctau) of GSK2336805 at Week 4|Blood samples for PK analysis of GSK2336805 was obtained on Week 4+1 day at predose and at 1, 2, 4, 7, 24 hours post-dose.|Week 4 (24 h post dose)|Intensive PK Summary Population: Intensive PK Summary Population comprised of participants with evaluable GSK2336805 PK parameters at Week 4. Only participants available at the indicated time point were assessed (represented by n=X, X in category titles).||ng/mL||Geometric Coefficient of Variation|Geometric Mean
674537|NCT01648140|Secondary|Mean GSK2336805 Plasma Concentrations on Day 1, Day 2, Week 4, and Week 12|Plasma pharmacokinetic (PK) samples were collected for all participants on Day 1 (0 hour [h]-1h, 1h-4h, 4h-8h, 8h-20h), Day 2 (Predose [20-28h]), Week 4 (Predose [20-28h], 0h-1h, 1h-4h, 4h-8h, 8h-20h, 20h-28h) and Week 12 (Predose [20-28h]). PK Population is comprised of all participants who received GSK2336805 and underwent plasma PK sampling (intensive or sparse) during the study.|Day 1, Day 2, Week 4, and Week 12|PK Population included all participants who received GSK2336805 and underwent plasma PK sampling (intensive or sparse) during the study. Only participants for whom plasma PK samples were obtained were assessed (represented by n=X, X in category titles).||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
674538|NCT01648140|Secondary|Number of Participants Achieving Very Rapid Virologic Response (vRVR), Rapid Virologic Response (RVR), Complete Early Virologic Response (cEVR), Sustained Virologic Response 12 and 24 (SVR12 and SVR24) With Response Guided Treatment (RGT)|Blood samples for the determination of HCV RNA levels were collected at Screening and Baseline, every study visit during the Treatment Period, and at PT FU Weeks 4, 12, and 24. vRVR is defined as plasma HCV RNA <LLOQ and target not detected 2 weeks after initiation of therapy. RVR is defined as plasma HCV RNA <LLOQ and target not detected 4 weeks after initiation of therapy. cEVR is defined as plasma HCV RNA <LLOQ and target not detected 12 weeks after initiation of therapy. SVR12 is defined as plasma HCV RNA <LLOQ and target not detected 12 weeks after completion of all therapy. SVR24 is defined as plasma HCV RNA <LLOQ and target not detected 24 weeks after completion of all therapy. SVR24 with RGT are participants who achieved both SVR24 and eRVR.|From the start of the treatment up to PT FU Week 24|ITT Population||Participants|||Number
674579|NCT01647711|Primary|Percentage of Participants With Dose Limiting Toxicities|Percentage of participants with Dose Limiting Toxicities (DLTs), based on investigator assessment, for determination of Maximum Tolerated Dose (MTD). MTD was defined as the dose in which less than 2 of up to 6 patients developed a DLT.|28 days|Treated set including patients eligible for MTD determination||Percentage of participants|||Number
674539|NCT01648140|Secondary|Number of Participants With Any AEs and Any SAEs After Week 12|An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign(including an abnormal laboratory finding), symptom, or disease(new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, a congenital anomaly/birth defect, important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition.|From Week 12 up to PT Week 24 FU|Safety Population||Participants|||Number
674540|NCT01648140|Primary|Mean Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval and QT Interval Corrected Bazett's Formula (QTcB), QT Interval Corrected Using Fridericia’s Formula (QTcF) Values at the Indicated Time Points up to Week 12|The ECG parameters including PR interval, QRS duration, uncorrected QT interval, QTcB, QTcF were measured at Baseline, Weeks 1 and 12. Change from Baseline in ECG parameters are summarized for each post-Baseline assessment up to Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) and Weeks 1 and 12|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.||Milliseconds||Standard Deviation|Mean
674541|NCT01648140|Primary|Mean Change From Baseline in Electrocardiographic (ECG) Heart Rate Values at the Indicated Time Points up to Week 12|The ECG parameter heart rate was measured at Baseline, Weeks 1 and 12. Change from Baseline in ECG heart rate is summarized for each post-Baseline assessment up to Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) and Weeks 1 and 12|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.||Beats per minute||Standard Deviation|Mean
674542|NCT01648140|Primary|Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12|Urine samples were collected for urinalysis at Baseline, Weeks 2, 12, 18, 24, 48 and PT FU Weeks 4. Number of participants with shift from Baseline in urinalysis to normal (NL), abnormal (ANL) and missing (MIS) data up to Week 12 are summarized. Urine bilirubin (UBIL), urine glucose (UGLU), urine ketones (UKET), urine leukocyte esterase test (ULET) for detecting WBC, urine nitrite (UNIT), urine occult blood (UOB) were performed with dipstick method. Urine microscopy (UM) is performed to detect bacteria (BAC), red blood cells (RBC) and white blood cells (WBC). Other urinalysis parameter included urine pH (UpH) and urine specific gravity (USG). Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0), Weeks 2 and 12|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.||Participants|||Number
674543|NCT01648140|Primary|Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points up to Week 12|Blood samples were collected for the measurement of Creatinine Clearance at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. It is estimated by Cockcroft-Gault Equation. Change from Baseline in the Creatinine Clearance values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.||Milliliter per minute (mL/min)||Standard Deviation|Mean
674544|NCT01648140|Primary|Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12|Blood samples were collected for the measurement of Chloride, bicarbonate, glucose, potassium, sodium, inorganic phosphorus and urea/BUN at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the chloride, bicarbonate, glucose, potassium, sodium, inorganic phosphorus and urea/BUN values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.||Millimoles per liter||Standard Deviation|Mean
674545|NCT01648140|Primary|Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12|Blood samples were collected for the measurement of direct bilirubin, total bilirubin and creatinine at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the direct bilirubin, total bilirubin and creatinine values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.||Micromoles per liter||Standard Deviation|Mean
674754|NCT01645059|Secondary|Adjuvant Treatment and Age|"Adjuvant treatment and clinical profile (age)
The patients analysed in this outcome are patients initially diagnosed with localized breast cáncer (N=66)"|one day (there is no follow-up, it is a cross-sectional study)|||years||Standard Deviation|Mean
674546|NCT01648140|Primary|Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12|Blood samples were collected for the measurement of ALP, ALT, AST, CK and GGT at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4 Change from Baseline in the ALP, ALT, AST, CK and GGT values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.||International units per liter||Standard Deviation|Mean
674547|NCT01648140|Primary|Mean Change From Baseline in Albumin at the Indicated Time Points up to Week 12|Blood samples were collected for the measurement of albumin at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the albumin values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.||Grams per liter||Standard Deviation|Mean
674548|NCT01648140|Primary|Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points up to Week 12|Blood samples were collected for the measurement of mean corpuscle volume at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the mean corpuscle volume values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.||Femtoliters||Standard Deviation|Mean
674549|NCT01648140|Primary|Mean Change From Baseline in Hematocrit at the Indicated Time Points up to Week 12|Blood samples were collected for the measurement of hematocrit at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the hematocrit values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population||Ratio||Standard Deviation|Mean
674550|NCT01648140|Primary|Mean Change From Baseline in Hemoglobin at the Indicated Time Points up to Week 12|Blood samples were collected for the measurement of hemoglobin at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the hemoglobin values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.||Grams per liter||Standard Deviation|Mean
674551|NCT01648140|Primary|Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points up to Week 12|Blood samples were collected for the measurement of red blood cell count at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the red blood cell count values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.||Trillion cells per liter||Standard Deviation|Mean
674552|NCT01648140|Primary|Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12|Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count and white blood cell count at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the basophils, eosinophils, lymphocytes, total neutrophils, platelet count and white blood cell count values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.||Giga cells per liter||Standard Deviation|Mean
674580|NCT01647542|Secondary|Change From Baseline in 2-hour Postprandial Glucose (PPG) Following Oral Glucose Tolerance Test (OGTT) at Week 24|The change between the value of glucose after a meal, measured following OGTT collected at Week 24 relative to baseline. Oral glucose tolerance test measures glucose, insulin, and C-peptide through blood samples drawn at 0, 30, 60, 90, and 120 minutes following consumption of a 75 gram (g) glucose beverage.|Baseline and Week 24|FAS included of all randomized participants who received at least 1 dose of double blind study medication. Only participants with a baseline and at least 1 post-baseline value were included.||mg/dL||Standard Error|Least Squares Mean
674553|NCT01648140|Primary|Mean Change From Baseline in Heart Rate at the Indicated Time Points up to Week 12|Vital sign monitoring included heart rate, measured at the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4, 12 and 24. Change from Baseline in heart rate is summarized for each post-Baseline assessment upto Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) and Day 2, Weeks 1, 2, 4, 6, 8, and 12|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.||Beats per minute||Standard Deviation|Mean
674554|NCT01648140|Primary|Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12|Blood pressure measurements were taken to observe vital signs and included SBP and DBP at the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and Post-treatment (PT) Follow Up (FU) Weeks 4, 12 and 24. Change from Baseline in SBP and DBP is summarized for each post-Baseline assessment up to Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) up to 12-week treatment period|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.||Millimeters of mercury (mmHg)||Standard Deviation|Mean
674555|NCT01648140|Primary|Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs) up to Week 12|An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign(including an abnormal laboratory finding), symptom, or disease(new or exacerbated) temporally associated with the use of a medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, a congenital anomaly/birth defect, important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition.|From the start of study treatment up to Week 12|Safety Population: comprised of all participants who received at least 1 dose of study medication (GSK2336805 or telaprevir).||Participants|||Number
674556|NCT01648140|Primary|Number of Participants Achieving eRVR|eRVR is defined as plasma HCV ribonucleic acid (RNA) <lower limit of quantification (LLOQ) and target not detected at Weeks 4 and 12. Participants who discontinued prior to Week 12 assessments or had missing HCV RNA values at Weeks 4 and 12 were treated as non-responders.|Week 4 and Week 12|Intent-To-Treat (ITT) Population: comprised of all participants who met the study criteria and were randomly assigned to treatment in the study with documented evidence of having received at least 1 dose of randomized treatment and at least 1 post Baseline HCV RNA measurement.||Participants|||Number
674557|NCT01648101|Secondary|Incidence of New Seizure Types During the TrP in Participants Without a History of the Indicated Seizure Types at Baseline|A participant was considered to have new seizure types during the TrP if they experienced a new seizure types (such as SE, myoclonic, absence, secondary generalization) and had no prior history of these seizure types. At Screening, a history of previous seizure types was collected, with “Yes,” “No,” “IS,” “SE,” or “Unknown” being recorded for each of the seizures types. The history of seizure types was updated during the 8-week BP as pre-treatment status. New types of seizures during the TrP were recorded as A1=simple PS with motor signs; AX=simple PS without motor signs; B=complex PS; C=PS evolving to secondary generalized seizures; D1=absence of seizures; D2=myoclonic seizures; D3=clonic seizures; D4=tonic seizures; D5=tonic-clonic seizures; D6=atonic seizures; E=unclassified seizures; and SE=status epilepticus.|From Baseline up to Week 16|ITT Population.||Number of events|||Number
674558|NCT01648101|Secondary|Percentage of Seizure-free Days in the TrP|"The percentage of seizure-free days was calculated as: (total number of days without seizures in the TrP (TiP plus MP) / number of applicable days in the TrP) * 100. A seizure-free day is defined as a day with non-missing seizure data but without any seizures. A participant was considered to be seizure free during the TrP if he/she had no record of countable seizures of any type, no IS, and no SE during the TrP. Participants who had one or more days on which they recorded seizures as Not Done on the seizure calendar were not disqualified from being considered as seizure free for that day."|From Baseline up to Week 16|ITT Population.||Percentage of seizure-free days||Standard Deviation|Mean
674559|NCT01648101|Secondary|Percentage of Seizure-free Days in the MP|"The percentage of seizure-free days was calculated as: (total number of days without seizures in the MP / number of applicable days in the MP) * 100. A seizure-free day is defined as a day with non-missing seizure data but without any seizures. A participant was considered to be seizure free during the MP if he/she had no record of countable seizures of any type, no IS, and no SE during the MP. Participants who had one or more days on which they recorded seizures as Not Done on the seizure calendar were not disqualified from being considered as seizure free for that day."|From Week 4 up to Week 16|ITT Population.||Percentage of seizure-free days||Standard Deviation|Mean
674560|NCT01648101|Secondary|Number of Participants Who Were Seizure Free During the TrP|"A seizure free-day is defined as a day with non-missing seizure data but without any seizures. A participant was considered to be seizure free during the TrP if he/she had no record of countable seizures of any type, no IS, and no SE during the TrP. Participants who had one or more days on which they recorded seizures as Not Done on the seizure calendar were not disqualified from being considered as seizure free for that day. A participant was considered to be seizure free if they experienced no seizures in the TiP or MP regardless of how long they were in the study."|From Baseline up to Week 16|ITT Population.||Participants|||Number
674581|NCT01647542|Secondary|Change in Fasting Plasma Glucose From Baseline to Week 24|The change between the fasting plasma glucose value collected at Week 24 relative to baseline.|Baseline and Week 24|FAS included of all randomized participants who received at least 1 dose of double blind study medication. Only participants with a baseline and at least 1 post baseline value were included||Milligram per deciliter (mg/dL)||Standard Error|Least Squares Mean
675820|NCT01634256|Primary|Changes in ALT(Alanine Transaminase)|ALT was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis||IU/L||Standard Deviation|Mean
674562|NCT01648101|Secondary|Percent Change From Baseline in the 28-day Total POS Frequency During the TrP Categorized as: >25% Increase and 0% to 25% Increase|The 28-day total POS frequency was calculated as: (total number of PS over the time period of interest [TrP; TiP plus MP] / number of applicable days in that period) * 28. In a case of one or more occurrences of IS on a day, these seizures were to be counted as an additional 10 seizures for that day, regardless of whether the IS were PS or not, and regardless of the number of occurrences of IS on that day. The number of applicable days in a phase for seizure data is calculated as: the end date of the TrP minus the start date of the TrP minus days on which seizures were recorded as “Not Done” during the TrP plus 1. Percent change from Baseline was calculated as: ([the 28-day PS rate for the period of interest (TrP) minus the Baseline 28-day PS rate] / Baseline 28-day PS rate) * 100. A negative percent change indicates a reduction (improvement) from Baseline; thus, the best possible outcome is -100% (100% reduction). There was no theoretical upper limit for worsening.|From Baseline up to Week 16|ITT Population: Due to the early termination of the study, insufficient data are available to perform these analysis.|||||
674563|NCT01648101|Secondary|Percent Change From Baseline in the 28-day Total POS Frequency During the MP Categorized as: >25% Increase and 0% to 25% Increase|The 28-day total POS frequency was calculated as: (total number of PS over the time period of interest [MP] / number of applicable days in that period) * 28. In a case of one or more occurrences of IS on a day, these seizures were to be counted as an additional 10 seizures for that day, regardless of whether the IS were PS or not, and regardless of the number of occurrences of IS on that day. The number of applicable days in a phase for seizure data is calculated as: the end date of the MP minus the start date of the MP minus days on which seizures were recorded as “Not Done” during the MP plus 1. Percent change from Baseline was calculated as: ([the 28-day PS rate for the period of interest (MP) minus the Baseline 28-day PS rate] / Baseline 28-day PS rate) * 100. A negative percent change indicates a reduction (improvement) from Baseline; thus, the best possible outcome is -100% (100% reduction). There was no theoretical upper limit for worsening.|Baseline; Week 4 up to Week 16|ITT Population: Due to the early termination of the study, insufficient data are available to perform these analysis.|||||
674564|NCT01648101|Secondary|Percent Change From Baseline in 28 Day Total POS Frequency During the TrP Categorized as: no Change/Increase, >0% to <50% Decrease, 50% to 75% Decrease, and >75% to 100% Decrease|The 28-day total POS frequency was calculated as: (total number of PS over the time period of interest [TrP; TiP plus MP] / number of applicable days in that period) * 28. In a case of one or more occurrences of IS on a day, these seizures were to be counted as an additional 10 seizures for that day, regardless of whether the IS were PS or not, and regardless of the number of occurrences of IS on that day. The number of applicable days in a phase for seizure data is calculated as: the end date of the TrP minus the start date of the TrP minus days on which seizures were recorded as “Not Done” during the TrP plus 1. Percent change from Baseline was calculated as: ([the 28-day PS rate for the period of interest (TrP) minus the Baseline 28-day PS rate] / Baseline 28-day PS rate) * 100. A negative percent change indicates a reduction (improvement) from Baseline; thus, the best possible outcome is -100% (100% reduction). There was no theoretical upper limit for worsening.|From Baseline up to Week 16|ITT Population: Due to the early termination of the study, insufficient data are available to perform these analysis.|||||
674565|NCT01648101|Secondary|Percent Change From Baseline in the 28-day Total POS Frequency During the MP Categorized as: no Change/Increase, >0% to <50% Decrease, 50% to 75% Decrease, and >75% to 100% Decrease|The 28-day total POS frequency was calculated as: (total number of PS over the time period of interest [MP] / number of applicable days in that period) * 28. In a case of >=1 occurrence of IS on a day, these seizures were to be counted as an additional 10 seizures for that day, regardless of whether the IS were PS or not, and regardless of the number of occurrences of IS on that day. The number of applicable days in a phase for seizure data is calculated as: the end date of the MP minus the start date of the MP minus days on which seizures were recorded as “Not Done” during the MP plus 1. Percent change from Baseline was calculated as: ([the 28-day PS rate for the period of interest (MP) minus the Baseline 28-day PS rate] / Baseline 28-day PS rate) * 100. A negative percent change indicates a reduction (improvement) from Baseline. There was no theoretical upper limit for worsening. Each occurrence of status epilepticus (SE) was counted as 1 seizure (whether partial status or not).|Baseline; Week 4 up to Week 16|ITT Population: Due to the early termination of the study, insufficient data are available to perform these analysis.|||||
674566|NCT01648101|Secondary|Percent Change From Baseline in the 28-day Total POS Frequency During the TrP|The 28-day total POS frequency was calculated as: (total number of PS over the time period of interest [TrP; TiP plus MP] / number of applicable days in that period) * 28. In a case of one or more occurrences of IS on a day, these seizures were to be counted as an additional 10 seizures for that day, regardless of whether the IS were PS or not, and regardless of the number of occurrences of IS on that day. The number of applicable days in a phase for seizure data is calculated as: the end date of the TrP minus the start date of the TrP minus days on which seizures were recorded as “Not Done” during the TrP plus 1. Percent change from Baseline was calculated as: ([the 28-day PS rate for the period of interest (TrP) minus the Baseline 28-day PS rate] / Baseline 28-day PS rate) * 100. A negative percent change indicates a reduction (improvement) from Baseline; thus, the best possible outcome is -100% (100% reduction). There was no theoretical upper limit for worsening.|From Baseline up to Week 16|ITT Population. Participants who dropped out during the TiP were calculated based on TiP data. For all others both Titration and Maintenance Phase data were used||Percent change||Full Range|Median
674567|NCT01648101|Secondary|Percent Change From Baseline in the 28-day Total POS Frequency During the MP|The 28-day total POS frequency was calculated as: (total number of PS over the time period of interest [MP] / number of applicable days in that period) * 28. In a case of one or more occurrences of IS on a day, these seizures were to be counted as an additional 10 seizures for that day, regardless of whether the IS were PS or not, and regardless of the number of occurrences of IS on that day. The number of applicable days in a phase for seizure data is calculated as: the end date of the MP minus the start date of the MP minus days on which seizures were recorded as “Not Done” during the MP plus 1. Percent change from Baseline was calculated as: ([the 28-day PS rate for the period of interest (MP) minus the Baseline 28-day PS rate] / Baseline 28-day PS rate) * 100. A negative percent change indicates a reduction (improvement) from Baseline; thus, the best possible outcome is -100% (100% reduction). There was no theoretical upper limit for worsening.|Baseline; Week 4 up to Week 16|ITT Population. Participants who dropped out during the TiP were calculated based on TiP data. For all others, only MP data were used.||Percent change||Full Range|Median
674568|NCT01648101|Secondary|Number of Responders From the BP to the Treatment Phase (TrP)|A “responder” is defined as a participant experiencing a >=50% reduction in the 28-day total POS frequency from the BP to the TrP (TiP plus MP). The 28-day total POS frequency was calculated as: (total number of PS over the time period of interest [TrP] / number of applicable days in that period) * 28. In a case of one or more occurrences of IS on a day, these seizures were to be counted as an additional 10 seizures for that day, regardless of whether the IS were PS or not, and regardless of the number of occurrences of IS on that day. The number of applicable days in a phase for seizure data is calculated as: the end date of the TrP minus the start date of the TrP minus days on which seizures were recorded as “Not Done” during the TrP plus 1). Each occurrence of SE was counted as 1 seizure (whether partial status or not).|From Baseline up to Week 16|Intent-to-Treat (ITT) Population||Participants|||Number
674569|NCT01648101|Secondary|Number of Placebo and Retigabine 600 mg Responders During the MP|A “responder” is defined as a participant experiencing a >=50% reduction in the 28-day total POS frequency from the BP to the MP, randomly assigned to retigabine 600 mg/day compared to placebo. The 28-day total POS frequency was calculated as: (total number of PS over the time period of interest [MP] / number of applicable days in that period) * 28. In a case of one or more occurrences of IS on a day, these seizures were to be counted as an additional 10 seizures for that day, regardless of whether the IS were PS or not, and regardless of the number of occurrences of IS on that day. The number of applicable days in a phase for seizure data is calculated as: the end date of the MP minus the start date of the MP minus days on which seizures were recorded as “Not Done” during the MP plus 1). Each occurrence of SE was counted as 1 seizure (whether partial status or not).|Baseline; Week 4 up to Week 16|ITT Population: all par. who were randomly assigned to treatment; rec'd≥1 dose (or any portion of dose) of study medication; had BL sz data; and had ≥1 post-BL sz record (whether or not they had a sz) between start of TiP and end of MP. Par. who dropped out during TiP were classified as non-responders. For all other par. only MP data were used.||Participants|||Number
674570|NCT01648101|Primary|Number of Placebo and Retigabine 900 mg Responders During the Maintenance Phase (MP)|A responder is defined as a par. with >=50% reduction in the 28 day total partial on-set seizure (POS) frequency from the Baseline Phase (BP) to the MP, randomly assigned to retigabine 900 mg/day compared with placebo. The total 28-day POS rate was defined as: (total number of POS over the evaluable period (MP) / number of days of seizure (sz) data in the evaluable period) *28 days. In the event of one or more innumerable seizures (IS) occurring on a day, these were to be counted as an additional 10 seizures for that day, regardless of the number of occurrences of IS on that day. The number of applicable days in a phase for seizure data is calculated as: the end date of MP minus start date of the MP minus days on which seizures were recorded as “Not done” + 1). Each occurrence of status epilepticus (SE) was counted as 1 seizure (whether partial or not).|Baseline (BL); Week 4 up to Week 16|ITT Population: all par. who were randomly assigned to treatment; rec'd≥1 dose (or any portion of dose) of study medication; had BL sz data; and had ≥1 post-BL sz record (whether or not they had a sz) between start of TiP and end of MP. Par. who dropped out during TiP were classified as non-responders. For all other par. only MP data were used.||Participants|||Number
674571|NCT01647945|Secondary|Efficacy of Low-dose FK-506 in Pulmonary Arterial Hypertension (PAH) Measured by Change in 6-min Walk Distance (6MWD)|"Change in 6MWD in meter between baseline and 16 weeks
A large number would indicate an increase in exercise capacity"|baseline to 16 weeks|Only subjects were included who finished the 16-week study 3 patients did not finish||meter||Inter-Quartile Range|Median
674572|NCT01647945|Secondary|Number of Combined Clinical Events|"Combined Clinical Events @ 16 weeks:
Number of patients who died Number of patients who got transplanted Number of patients who needed escalation of therapies Number of patients who had worsening of NYHA/WHO classification by at least 1 point Number of patients who require hospitalization for right heart failure
Low numbers would suggest either efficacy of the study drug or slowly progression of disease that is studied during the 16 week study period or short observation period or small study population"|Baseline to 16 weeks|Subjects were included who finished the 16 week study period. A total of 3 participants did not complete the study||Combined Number of Clinical Events|||Number
674573|NCT01647945|Primary|Safety of Low-dose FK-506 in PAH|Total number of adverse events measured between baseline and end of study at 18 weeks as reported by study subjects such as nausea/diarrhea, URI, sinus congestion, infection, fluid retention/edema, cough, headache, bronchitis, fatigue, drug reaction/hives, flushing, anxiety, tremor, fever, shingles, SOB, insomnia, pain|18 weeks|all study subjects who started the study||number of AEs|||Number
674574|NCT01647737|Primary|Change in Salivary Flow From Baseline|Change in salivary flow in Xerostomic patients using Green tea lozenges|8 weeks|Enrolled subjects completing 8 weeks of treatment||ml/min||Standard Deviation|Mean
674575|NCT01647711|Primary|Maximum Tolerated Dose|Maximum Tolerated Dose (MTD) was defined as the dose in which less than 2 of up to 6 patients developed a Dose Limiting Toxicity (DLT).|28 days|Treated set including patients eligible for MTD determination||mg|||Number
674576|NCT01647711|Secondary|Determination of Dosage for Expansion Cohort in Part B|Determination of dosage for expansion cohort in Part B. Dosage was the MTD or less depending on tolerability.|28 days|Treated set including patients eligible for MTD determination||mg|||Number
674577|NCT01647711|Secondary|Cmax of Afatinib on Day 3 of Course 1|Maximum measured concentration (Cmax) of afatinib as determined on day 3 of course 1 for patients in Part A|47 hours (h) 55 minutes (min), 49h, 50h, 51h, 52h, 53h, 54h, 55h after first dose administration (on day 3 of course 1)|Pharmacokinetic set which included all patients treated in part A who were documented to have taken at least one dose of afatinib and who had in addition at least one valid afatinib concentration available.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
674578|NCT01647711|Secondary|Objective Response Rate for Patients With EGFR T790M Mutations|"Objective response rate for patients with Epidermal Growth Factor Receptor (EGFR) T790M mutations. Objective response was defined as Complete Response (CR): Disappearance of all target lesion or Partial Response and (PR): >=30% decrease in the sum of the longest diameter of target lesions, according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1.
This endpoint was originally planned to be analysed in part B of the study, however as no participants were treated in part B the analysis was performed on the part A participants."|From first drug administration until last drug administration, up to 420 days|Treated set including participants with EGFR T790M positive mutations||Percentage of participants|||Number
674583|NCT01647542|Primary|Change From Baseline in HbA1c at Week 24|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 24 relative to baseline.|Baseline and Week 24|Full Analysis Set (FAS) included of all randomized participants who received at least 1 dose of double blind study medication. Only participants with a baseline and at least 1 post-baseline value were included.||Percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
674584|NCT01647464|Primary|Renal Video Intensity Units|Video intensity units in the kidney 10 min after completion of a clinically indicated contrast echocardiography study.|10 min|||units on a scale||Standard Deviation|Mean
674585|NCT01647438|Primary|Change in Saturated Fat (% of Daily Kilo-calories From Fat) Intake|Change from baseline in saturated fat (% of daily kilo-calories from fat) intake measured by 24-hour food recall at 6-months|baseline and 6-months|||percentage of kilocalories||Standard Error|Mean
674586|NCT01647438|Primary|Change in Physical Activity (Minutes/Week)|Change from baseline in minutes per week of physical activity measured by accelerometer at 6-months.|baseline and 6-months|||min/week||Standard Error|Mean
674587|NCT01647217|Secondary|Change in Lid Margin Redness and Bulbar Conjunctival Hyperemia|Lid margin redness and bulbar conjunctival hyperemia were each assessed using an ordered categorical value ranging from 0 (None) to 3 (Severe). The two scores were summed to obtain the final score, which ranges from 0 (None) to 6 (Severe).|Baseline and 6 weeks|||units on a scale||Standard Deviation|Mean
674588|NCT01647217|Primary|Change in the Number of Demodex Mites|"Change in mites count after treatment compared to the baseline data. If the mites' count remains zero during the last two visits, it is considered complete eradication. Patients without achieving complete eradication will be categorized as incomplete eradication."|6 weeks|||Mites||Standard Deviation|Mean
674589|NCT01646827|Secondary|Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale.|This scale consists of a baseline evaluation that assesses the lifetime experience of the participant with suicide events and suicidal ideation and a post baseline evaluation that focuses on suicidality since the last trial visit.|Screening, Baseline, Week 1, Week 2, Week 8, Week 18 visit and Last visit.|Population included all randomized participants who received at least one dose of drug, regardless of any protocol violation.||Participants|||Number
674590|NCT01646827|Secondary|Visual Analog Scale (VAS) Score at Day 1, Day 14, Day 28 and Last Visit.|Injection site pain was assessed using a VAS, which was completed by the trial participant, and the investigator’s assessment of most recent injection site, which was completed by the investigator. VAS is 100 mm line, 0=no pain, 100=unbearably painful.|Day 1, Day 14, Day 28 and last visit|Population included all randomized participants who received at least one dose of drug, regardless of any protocol violation.||Units on a scale||Standard Deviation|Mean
674591|NCT01646827|Secondary|Number of Participants With Electrocardiogram (ECG) Measurements of Potential Clinical Relevance|Three 12 lead ECGs were performed approximately 5 minutes apart at each time point. The participant were supine and at rest (for at least 10 minutes) prior to the first ECG and will remain supine through the final ECG. Based on criteria for identifying ECG measurements of potential clinical relevance, the abnormal values were noted. Some of the criteria are as follows: For bradycardia: ≤ 50 beats per minute (bpm); and for increase in QTc: QTc ≥ 450msec.|Day 1, Day 14, Day 28 and Day 126/Early termination|Population included all randomized participants who received at least one dose of drug, regardless of any protocol violation.||Participants|||Number
674592|NCT01646827|Secondary|Number of Participants With Vital Signs of Potential Clinical Relevance-Heart Rate|Vital sign assessment included heart rate (supine and standing). Heart rate with increase or decrease of >/= 15 beats per minute were recorded.|Day 1, Day 14, Day 28 and Day 126/Early termination|Population included all randomized participants who received at least one dose of drug, regardless of any protocol violation.||Participants|||Number
674593|NCT01646827|Secondary|Number of Participants With Vital Signs of Potential Clinical Relevance-Temperature|Vital sign assessment included body temperature measured in centigrade(C). Temperatures >=37.8°C and increase of >= 1.1°C were recorded.|Day 1, Day 14, Day 28 and Day 126/Early termination|Population included all randomized participants who received at least one dose of drug, regardless of any protocol violation.||Participants|||Number
674594|NCT01646827|Secondary|Number of Participants With Vital Signs of Potential Clinical Relevance-Blood Pressure|Vital sign assessment included orthostatic (supine and standing) blood pressure. Orthostatic assessments were made after participants had been in the supine position for at least 5 minutes and again after participants had been standing for 2 minutes, but not more than 3 minutes. Orthostatic hypotension defined as >/= 20 mm Hg decrease in systolic blood pressure and >/= 25 beats per minute increase in heart rate from supine to standing.|Day 1, Day 14, Day 28 and Day 126/Early termination|Population included all randomized participants who received at least one dose of drug, regardless of any protocol violation.||Participants|||Number
674595|NCT01646827|Secondary|Number of Participants With Laboratory Values of Potential Clinical Relevance.|The laboratory tests were collected and processed in accordance with directions from the clinical chemistry laboratory. Based on criteria for identifying laboratory values of potential clinical relevance, the abnormal values were noted. Some of the criteria are as follows: For fasting triglycerides: men: ≥ 160 mg/dL and women: ≥ 120 mg/dL; Fasting glucose: ≥ 115 mg/dL; Prolactin: > upper limit of normal (ULN); Neutrophils: ≤ 1,500/mm3; and Creatine phosphokinase: ≥ 3 x ULN.|Day 1, Day 28, Day 126/Early termination|Population included all randomized participants who received at least one dose of drug, regardless of any protocol violation.||Participants|||Number
674596|NCT01646827|Secondary|Number of Participants Reporting Treatment Emergent Adverse Events (TEAE).|Safety was measured according to standard adverse event collection as described in the adverse event section of the results.|Starting at the time the ICF was signed to Day 126/Early termination|Population included all randomized participants who received at least one dose of drug, regardless of any protocol violation.||Participants|||Number
674608|NCT01646671|Secondary|Percentage of Participants With DBP Response at End of Study|DBP response was defined as <90 mmHg or a reduction ≥ 10 mmHg from baseline.|Baseline, 8 weeks|Full Analysis Set: included all patients who entered the treatment epoch. This set was determined by the maximum treatment patients received, i.e. combination of the highest LCZ696 dose and use of newly introduced anti-HTN medication/dose escalation of base anti-HTN medication during the treatment epoch.||Percentage of Participants|||Number
674597|NCT01646827|Primary|Area Under the Concentration-Time Curve Infinity (AUC Infinity); Area Under the Concentration-Time Curve 28 (AUC 28), and Area Under the Concentration-Time Curve t (AUC t): Dehydro-Aripiprazole|Relative bioavailability (Frel) of aripiprazole IM depot injected in the deltoid muscle compared to the gluteal muscle based on area under the concentration-time curve (AUC) from time zero to the time of last measurable concentration (AUCt), AUC time curve 28 and AUC from time zero to infinity PK parameters.|Day 1: 4 hr, 8 hr, and 12 hr post dose, Days 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25, 28, 35, 42, 49, 56, 63, 70, 77, 84, 98, 112 and 126/Early termination|The dataset for the PK analysis consisted of all dosed subjects who had evaluable aripiprazole and dehydro-aripiprazole PK parameters.||ng day/mL||Standard Deviation|Mean
674598|NCT01646827|Primary|Maximum Observed Plasma Concentration (Cmax) of Dehydro-Aripiprazole|Relative bioavailability (Frel) of aripiprazole intramuscular (IM) depot injected in the deltoid muscle compared to the gluteal muscle based on aripiprazole maximum (peak) plasma concentrations (Cmax) PK parameter.|Day 1: 4 hr, 8 hr, and 12 hr post dose, Days 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25, 28, 35, 42, 49, 56, 63, 70, 77, 84, 98, 112 and 126/Early termination|The dataset for the PK analysis consisted of all dosed subjects who had evaluable aripiprazole and dehydro-aripiprazole PK parameters.||ng/mL||Standard Deviation|Mean
674599|NCT01646827|Primary|Area Under the Concentration-Time Curve Infinity (AUC Infinity); Area Under the Concentration-Time Curve 28 (AUC 28), and Area Under the Concentration-Time Curve t (AUC t): Aripiprazole|Relative bioavailability (Frel) of aripiprazole IM depot injected in the deltoid muscle compared to the gluteal muscle based on area under the concentration-time curve (AUC) from time zero to the time of last measurable concentration (AUCt), AUC time curve 28, and AUC from time zero to infinity PK parameters.|Day 1: 4 hr, 8 hr, and 12 hr post dose, Days 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25, 28, 35, 42, 49, 56, 63, 70, 77, 84, 98, 112 and 126/Early termination|The dataset for the PK analysis consisted of all dosed subjects who had evaluable aripiprazole and dehydro-aripiprazole PK parameters.||ng day/mL||Standard Deviation|Mean
674600|NCT01646827|Primary|Maximum Observed Plasma Concentration (Cmax) of Aripriprazole|Relative bioavailability (Frel) of aripiprazole intramuscular (IM) depot injected in the deltoid muscle compared to the gluteal muscle based on aripiprazole maximum (peak) plasma concentrations (Cmax) PK parameter.|Day 1: 4 hr, 8 hr, and 12 hr post dose, Days 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25, 28, 35, 42, 49, 56, 63, 70, 77, 84, 98, 112 and 126/Early termination|The dataset for the PK analysis consisted of all dosed subjects who had evaluable aripiprazole and dehydro-aripiprazole PK parameters.||ng/mL||Standard Deviation|Mean
674601|NCT01646814|Primary|Incidence of Gastroduodenal Ulcers|Cumulative Incidence of Gastroduodenal Ulcers Greater than or equal to 3 mm in length with unequivocal depth|42 Days|Per protocol population (ie, Treated with ≥1 dose and Day 7 dose administered and endoscopy performed and ≥85% compliant)||participants|||Number
674609|NCT01646671|Secondary|Percentage of Participants With SBP Response at End of Study|SBP response was defined as <140 mmHg or a reduction ≥ 20 mmHg from baseline.|Baseline, 8 weeks|Full Analysis Set: included all patients who entered the treatment epoch. This set was determined by the maximum treatment patients received, i.e. combination of the highest LCZ696 dose and use of newly introduced anti-HTN medication/dose escalation of base anti-HTN medication during the treatment epoch.||Percentage of Participants|||Number
674610|NCT01646671|Secondary|Percentage of Participants Achieving Successful msDBP Control at End of Study|Successful msDBP control in patients with severe hypertension at the end of study treatment was defined as msDBP < 90 mmHg.|8 weeks|Full Analysis Set: included all patients who entered the treatment epoch. This set was determined by the maximum treatment patients received, i.e. combination of the highest LCZ696 dose and use of newly introduced anti-HTN medication/dose escalation of base anti-HTN medication during the treatment epoch.||Percentage of Participants|||Number
674611|NCT01646671|Secondary|Percentage of Participants Achieving Successful msSBP Control at End of Study|Successful msSBP control in patients with severe hypertension at the end of study treatment was defined as msSBP <140 mmHg.|8 weeks|Full Analysis Set: included all patients who entered the treatment epoch. This set was determined by the maximum treatment patients received, i.e. combination of the highest LCZ696 dose and use of newly introduced anti-HTN medication/dose escalation of base anti-HTN medication during the treatment epoch.||Percentage of Participants|||Number
674612|NCT01646671|Secondary|Percentage of Participants With Successful Blood Pressure (BP) Control in msSBP/msDBP at End of Study|Successful BP control in patients with severe hypertension at the end of study treatment was defined as follows: msSBP/msDBP< 140/90 mmHg.|8 weeks|Full Analysis Set: included all patients who entered the treatment epoch. This set was determined by the maximum treatment patients received, i.e. combination of the highest LCZ696 dose and use of newly introduced anti-HTN medication/dose escalation of base anti-HTN medication during the treatment epoch.||Percentage of Participants|||Number
674613|NCT01646671|Secondary|Change From Baseline in msSBP and msDBP at Week 8|Sitting BP measurements were performed at screening through the end of study at every visit. Four separate sitting BP measurements were obtained with a full two-minute interval between measurements. The 4 measurements were summed and averaged, and then the baseline BP value was subtracted from the average value to get the change from baseline value.|Baseline, 8 weeks|Full Analysis Set: included all patients who entered the treatment epoch. This set was determined by the maximum treatment patients received, i.e. combination of the highest LCZ696 dose and use of newly introduced anti-HTN medication/dose escalation of base anti-HTN medication during the treatment epoch.||mmHg||Standard Deviation|Mean
674614|NCT01646671|Primary|Percentage of Participants With Adverse Events (AEs), Serious Adverse Events and Deaths|Adverse events, serious adverse events deaths were monitored from screening to week 8.|Week 8|AE analysis was determined by actual treatment, i.e. the LCZ696 dose and use of newly introduced anti-HTN medication/dose escalation of base anti-HTN medication on the day in which the corresponding summary was targeting. Participants could be counted in more than one category. Other safety analysis was determined by the maximum treatment.||Percentage of participants|||Number
674615|NCT01646398|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination|Systemic events reported using an electronic diary. Systemic events are any fever greater than or equal to (>=) 37.5 degrees Celsius [C], fatigue, headache, chills, rash, vomiting, decreased appetite, new muscle pain, aggravated muscle pain, new joint pain, aggravated joint pain, use of medication to treat fever and use of medication to treat pain. All reports of fever >=39 degrees C in 13vPnC and 23vPS were confirmed as data entry errors.|Within 14 days after vaccination|Safety population included all participants who received the study vaccine. 'N' (number of participants analyzed)=participants with known values for any systemic events. 'n'=number of participants with known values for specified systemic events for each group respectively. Participants may be represented in more than 1 category.||percentage of participants||95% Confidence Interval|Number
674616|NCT01646398|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination|Local reactions reported using an electronic diary. Redness and swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters [cm]; Moderate (5.1 to 10.0 cm); Severe (>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).|Within 14 days after vaccination|Safety population included all participants who received the study vaccine. 'N' (number of participants analyzed)=participants with known values for any local reaction. 'n'=number of participants with known values for specified local reaction for each group respectively. Participants may be represented in more than 1 category.||percentage of participants||95% Confidence Interval|Number
674617|NCT01646398|Secondary|Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes and Serotype 6A 1 Month After Vaccination|Antibody-mediated serum OPA against each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) was measured centrally using a quantitative functional microcolonoy OPA (mcOPA) assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs).|One month after vaccination|Evaluable immunogenicity population:eligible participants, received study vaccine to which randomized, received no prohibited vaccines, had at least 1 valid and determinate assay result, had blood drawn within prescribed time frame and had no major protocol violations. n= number of participants with determinate OPA antibody titer to given serotype.||titer||95% Confidence Interval|Geometric Mean
674618|NCT01646398|Primary|Percentage of Participants Achieving At Least a 4-fold Rise in OPA Titers for Serotype 6A 1 Month After Vaccination|For serotype 6A the percentage of participants achieving at least a 4-fold rise on the serotype-specific antibody titer from pre-vaccination to 1 month post-vaccination was computed along with exact, 2-sided 95% confidence interval for the proportion.|One month after vaccination|Evaluable immunogenicity population. Here ‘N’ (number of participants analyzed) signifies participants with determinate fold rise of OPA antibody titer to serotype 6A.||percentage of participants||95% Confidence Interval|Number
674755|NCT01645059|Secondary|The Pattern of Treatment in Metastatic Breast Cancer: Chemotherapy, Hormonal Therapy Anti-HER Biological Therapy||one day (there is no follow-up, it si a cross-sectional study)|||percentage of participants|||Number
674619|NCT01646398|Primary|Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes 1 Month After Vaccination|Antibody-mediated serum OPA against each of the 12 pneumococcal serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) was measured centrally using a quantitative functional microcolony OPA (mcOPA) assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs).|One month after vaccination|Evaluable immunogenicity population:eligible participants, received study vaccine to which randomized, received no prohibited vaccines, had at least 1 valid and determinate assay result, had blood drawn within prescribed time frame and had no major protocol violations. n= number of participants with determinate OPA antibody titer to given serotype.||titer||95% Confidence Interval|Geometric Mean
674620|NCT01646385|Secondary|Health Assessment Questionnaire (HAQ) Score 6 Months Prior to And 6 Months Post-Switching Etanercept|HAQ: self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ score range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation.|6 months prior to and 6 months post switching etanercept|FAS population. Here “N” (number of participants analyzed): participants evaluable for this measure, “n”: participants evaluable for specified time-points. Only participants treated with ETN were to be analyzed for this outcome measure.||units on a scale||Standard Deviation|Mean
674621|NCT01646385|Secondary|Percentage of Participants With Remission Based on Health Assessment Questionnaire (HAQ) Score|HAQ: self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ score range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ total scores expressed as overall mean score with range 0-3. Participants who had HAQ total score <=0.5 were considered in remission state.|Year 1, 2, 3|FAS included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of 1 consultant follow-up after baseline registration. N (number of participants analyzed): participants evaluable for this measure, n: participants evaluable for specified time-points for each treatment arm, respectively.||percentage of participants|||Number
674622|NCT01646385|Secondary|Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Year 1, 2, and 3|HAQ: self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ score range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation.|Baseline, Year 1, 2, 3|FAS included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of 1 consultant follow-up after baseline registration. N (number of participants analyzed): participants evaluable for this measure, n: participants evaluable for specified time-points for each treatment arm, respectively.||units on a scale||95% Confidence Interval|Least Squares Mean
674623|NCT01646385|Secondary|Health Assessment Questionnaire (HAQ) Score at Baseline|HAQ: self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ score range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation.|Baseline|FAS population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration.||units on a scale||Standard Deviation|Mean
674624|NCT01646385|Secondary|Time to Remission|DAS28 calculated from SJC and TJC using the 28 joints count, the serological markers of inflammation (ESR [millimeter per hour] or CRP [milligram per liter]) and patient's general health assessment (recorded on a VAS scale of 0 mm-100 mm). DAS28 <=1.6 = remission, DAS28 <=2.4 = low disease activity, DAS28 >=3.2 to 5.1 = moderate disease activity, DAS28 >5.1 = severe disease activity. Time to achieve remission was calculated by Kaplan-Meier survival analysis.|Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years|FAS population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration.||years||95% Confidence Interval|Median
674625|NCT01646385|Secondary|Percentage of Participants With Remission and Low Disease Activity as Assessed by Disease Activity Score Based on 28-Joints Count (DAS28)|DAS28 calculated from SJC and TJC using the 28 joints count, the serological markers of inflammation (ESR [millimeter per hour] or CRP [milligram per liter]) and patient's general health assessment (recorded on a VAS scale of 0 mm-100 mm). DAS28 <=1.6 = remission, DAS28 <=2.4 = low disease activity, DAS28 >=3.2 to 5.1 = moderate disease activity, DAS28 >5.1 = severe disease activity.|Year 1, 2, 3, 4, 5|FAS included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of 1 consultant follow-up after baseline registration. N (number of participants analyzed): participants evaluable for this measure, n: participants evaluable for specified time-points for each treatment arm, respectively.||percentage of participants|||Number
674635|NCT01646320|Secondary|Percentage of Subjects Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])|Percent adjusted for baseline HbA1c. Therapeutic glycemic response is defined as HbA1c <7.0%. Data after rescue medication was excluded from this analysis.|From baseline to week 24|The Randomized Subjects Data Set consists of all randomized subjects who received at least one dose of double-blind study medication during the double-blind treatment period||Percentage of subjects|||Number
681076|NCT01562314|Secondary|Plasma Endocannabinoid Levels - 2-arachidonoyl Glycerol (2-AG)|Change from baseline in the endocannabinoid 2-AG|Baseline to end of treatment (10 weeks treatment period)|ITT analysis set||nmol/L||Standard Deviation|Mean
674626|NCT01646385|Secondary|Change From Baseline in Disease Activity Score Based on 28-Joints Count (DAS28) at Year 1, 2, 3, 4, and 5|DAS28 calculated from SJC and TJC using the 28 joints count, the serological markers of inflammation (ESR [millimeter per hour] or CRP [milligram per liter]) and patient's general health assessment (recorded on a VAS scale of 0 mm-100 mm). DAS28 <=1.6 = remission, DAS28 <=2.4 = low disease activity, DAS28 >=3.2 to 5.1 = moderate disease activity, DAS28 >5.1 = severe disease activity.|Baseline, Year 1, 2, 3, 4, 5|FAS included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of 1 consultant follow-up after baseline registration. N (number of participants analyzed): participants evaluable for this measure, n: participants evaluable for specified time-points for each treatment arm, respectively.||units on a scale||95% Confidence Interval|Least Squares Mean
674627|NCT01646385|Secondary|Disease Activity Score Based on 28-Joints Count (DAS28) at Baseline|DAS28 calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joints count, the serological markers of inflammation (erythrocyte sedimentation rate [ESR, millimeter per hour] or C-reactive protein [CRP, milligram per liter]) and patient's general health assessment (recorded on a Visual Analog Scale [VAS] of 0 millimeter [mm]-100 mm). DAS28 <=1.6 = remission, DAS28 <=2.4 = low disease activity, DAS28 >=3.2 to 5.1 = moderate disease activity, DAS28 >5.1 = severe disease activity.|Baseline|FAS population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration.||units on a scale||Standard Deviation|Mean
674628|NCT01646385|Secondary|Time on Etanercept Therapy|Time on etanercept therapy was calculated by Kaplan-Meier survival analysis.|Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years|FAS population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration. Only participants treated with ETN were to be analyzed for this outcome measure.||years||95% Confidence Interval|Median
674629|NCT01646385|Secondary|Percentage of Participants Who Switched to Other Therapy Following Etanercept Discontinuation|Participants who switched from etanercept to either DMARDs or alternative biologic drug are reported.|Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years|Full Analysis set (FAS) population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration. Only participants treated with ETN were to be analyzed for this outcome measure.||percentage of participants|||Number
674630|NCT01646385|Primary|Crude Incidence Rate of All-Cause Mortality|Participant-Year estimated by calculating all of the years that participants in a study were followed (number of evaluable participants multiplied by total follow-up in years). Crude (unadjusted) incidence rate calculated as number of deaths divided by Participant-Year, multiplied by 1000. Death was recorded in the adverse outcomes table and in the consultant follow-up table. Where multiple events described death for the same participant, date of death was taken as per the earliest record.|Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years|Safety analysis population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration.||events per 1000 participant-years|||Number
674631|NCT01646385|Primary|Crude Incidence Rate of Other Serious Adverse Events|Participant-Year estimated by calculating all of the years that participants in a study were followed (number of evaluable participants multiplied by total follow-up in years). Crude (unadjusted) incidence rate calculated as number of other serious adverse events divided by Participant-Year, multiplied by 1000. Other serious adverse events were based on classifications assigned by the BSRBR and included cardiac serious adverse events (SAEs), central nervous system SAEs, and nonmalignant hematological SAEs.|Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years|Safety analysis population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration.||events per 1000 participant-years|||Number
674632|NCT01646385|Primary|Crude Incidence Rate of Serious Infections|Participant-Year estimated by calculating all of the years that participants in a study were followed (number of evaluable participants multiplied by total follow-up in years). Crude (unadjusted) incidence rate calculated as number of serious infections divided by Participant-Year, multiplied by 1000. Serious infections included those infections which required intravenous antibiotics, hospitalization, or resulted in death. Adverse outcome was defined as ‘serious infection’ in the field [serinf] labeled by BSRBR.|Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years|Safety analysis population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration.||events per 1000 participant-years|||Number
674633|NCT01646385|Primary|Crude Incidence Rate of Lymphoproliferative Malignancy (LM)|Participant-Year estimated by calculating all of years that participants in a study were followed (number of evaluable participants multiplied by mean follow-up in years). Crude (unadjusted) incidence rate calculated as number of LMs divided by Participant-Year, multiplied by 1000. Lymphoproliferative: medical condition characterized by the dysfunction of the immune system often resulting in excessive production of lymphocytes. LMs included lymphoma, myeloma, and leukemia. Adverse outcome was defined as ‘lymphoproliferative malignancy’ in the field [lymphopro] labeled by BSRBR.|Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years|Safety analysis population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration.||events per 1000 participant-years|||Number
674634|NCT01646385|Primary|Crude Incidence Rate of Malignancy|Participant-Year estimated by calculating all of the years that participants in a study were followed (number of evaluable participants multiplied by mean follow-up in years). Crude (unadjusted) incidence rate calculated as number of malignancy events divided by Participant-Year, multiplied by 1000.|Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years|Safety analysis population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration.||events per 1000 participant-years|||Number
674636|NCT01646320|Secondary|Adjusted Mean Change From Baseline in Body Weight at Week 24|Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weights were measured during the qualification and lead-in periods and on Day 1 and Weeks 6, 12, 18, and 24 in the double-blind period.|From baseline to Week 24|The Randomized Subjects Data Set consists of all randomized subjects who received at least one dose of double-blind study medication during the double-blind treatment period||kg||Standard Error|Least Squares Mean
674637|NCT01646320|Secondary|Adjusted Mean Change From Baseline in 120-minute Postprandial Glucose (PPG) at Week 24|2-hour postprandial glucose (PPG) from a liquid meal tolerance test (2-h MTT) Subject must be fasted for at least 8 hrs prior to the MTT.|From Baseline to Week 24|The Randomized Subjects Data Set consists of all randomized subjects who received at least one dose of double-blind study medication during the double-blind treatment period. Number of participants analyzed is the number of randomized subjects with non-missing baseline and Week 24 (LOCF) values.||mg/dL||Standard Error|Least Squares Mean
674638|NCT01646320|Secondary|Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 24|Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 6, 12, 18, and 24 in the double-blind period|From Baseline to Week 24|The Randomized Subjects Data Set consists of all randomized subjects who received at least one dose of double-blind study medication during the double-blind treatment period. Number of participants analyzed corresponds to the number of randomized subjects with non-missing baseline value and at least one post-baseline value.||mg/dL||Standard Error|Least Squares Mean
674639|NCT01646320|Primary|Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24|HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 6, 12, 18, and 24 in the double-blind period.|From Baseline to Week 24|The Randomized Subjects Data Set consists of all randomized subjects who received at least one dose of double-blind study medication during the double-blind treatment period.||Percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
674640|NCT01646268|Secondary|Change in Unified Parkinson’s Disease Rating Scale [UPDRS Part III (Motor Examination)] From Baseline to the End of the Double-blind Maintenance Period|"The UPDRS assessments (Parts II+III) will be performed at every visit.
For the assessment of the subject’s motor function, Part III of the UPDRS will be used and the assessments will be done while the subject is in the “on” state.
The UPDRS Part III (motor subscale) consists of 27 items and sub items scored between 0 and 4. The sum score ranges from 0 to 108, higher scores denote greater disability."|From Baseline (Week 0) to end of Maintenance Period (up to Week 24)|This analysis consists of the Full Analysis Set [Last Observation Carried Forward], which includes all subjects who are randomized, receive at least 1 dose of study medication, and have a Baseline efficacy measurement and at least 1 post-Baseline efficacy measurement.||units on a scale||Standard Deviation|Mean
674641|NCT01646268|Secondary|Change in Unified Parkinson's Disease Rating Scale [UPDRS Part II (ADL)] From Baseline to the End of the Double-blind Maintenance Period|"The UPDRS assessments (Parts II+III) will be performed at every visit.
For the assessment of the subject’s disability, Part II of the UPDRS will be used. Data will be gathered pertaining to the subject’s disease state in the “on” state. Subjects will respond to questions about their general state in the week prior to their scheduled visit in conjunction with any observations made by the investigator (or designee). The UPDRS Part II (Activities of Daily Living) consists of 13 items scored between 0 and 4. The sum score ranges from 0 to 52, higher scores denote greater disability."|From Baseline (Week 0) to end of Maintenance Period (up to Week 24)|This analysis consists of the Full Analysis Set [Last Observation Carried Forward], which includes all subjects who are randomized, receive at least 1 dose of study medication, and have a Baseline efficacy measurement and at least 1 post-Baseline efficacy measurement.||units on a scale||Standard Deviation|Mean
674642|NCT01646268|Secondary|Response to Therapy, Defined as ≥20 % Decrease in the Sum of Scores From Activities of Daily Living (ADL) & Motor Examination in Unified Parkinson's Disease Rating Scale (UPDRS Parts II+III, a UPDRS Subtotal) From Baseline to End of Maintenance Period|"The UPDRS assessments (Parts II+III) will be performed at every visit. For the assessment of the subject’s disability, Part II of the UPDRS will be used. Data will be gathered pertaining to the subject’s disease state in the “on” state. Subjects will respond to questions about their general state in the week prior to their scheduled visit in conjunction with any observations made by the investigator (or designee). For the assessment of the subject’s motor function, Part III of the UPDRS will be used and the assessments will be done while the subject is in the “on” state.
The UPDRS Part II (Activities of Daily Living) consists of 13 items scored between 0 and 4. The UPDRS Part III (motor subscale) consists of 27 items and sub items scored between 0 and 4. The sum score is calculated as sum of these 27 individual scores. A higher score denotes greater disability."|From Baseline (Week 0) to end of Maintenance Period (up to Week 24)|This analysis consists of the Full Analysis Set [Last Observation Carried Forward], which includes all subjects who are randomized, receive at least 1 dose of study medication, and have a Baseline efficacy measurement and at least 1 post-Baseline efficacy measurement.||percentage of responders|||Number
674689|NCT01646125|Secondary|Disease Control Rate (DCR)|Duration of DCR will be compared between treatment arms. The duration of DCR will be based on local investigator assessment per RECIST 1.1|baseline, until disease progression up to 24 months|The data monitoring committee (DMC's) recommendation based on the Interim Analysis (IA) results was to terminate the study early due to futility; collection of efficacy data for assessment was stopped at that time.|||||
674643|NCT01646268|Primary|Change in the Sum of the Score From the Activities of Daily Living (ADL) Scale and Motor Examination in the Unified Parkinson's Disease Rating Scale (UPDRS) (Parts II+III, a UPDRS Subtotal) From Baseline to the End of Double-blind Maintenance Period|"The UPDRS assessments (Parts II+III) will be performed at every visit.
For the assessment of the subject’s disability, Part II of the UPDRS will be used. Data will be gathered pertaining to the subject’s disease state in the “on” state. Subjects will respond to questions about their general state in the week prior to their scheduled visit in conjunction with any observations made by the investigator (or designee). For the assessment of the subject’s motor function, Part III of the UPDRS will be used and the assessments will be done while the subject is in the “on” state.
The UPDRS Part II (Activities of Daily Living) consists of 13 items scored between 0 and 4. The UPDRS Part III (motor subscale) consists of 27 items and sub items scored between 0 and 4. The sum score is calculated as sum of these 27 individual scores. The sum score ranges from 0 to 160, higher scores denote greater disability."|From Baseline (Week 0) to end of Maintenance Period (up to Week 24)|This analysis consists of the Full Analysis Set [Last Observation Carried Forward], which includes all subjects who are randomized, receive at least 1 dose of study medication, and have a Baseline efficacy measurement and at least 1 post-Baseline efficacy measurement.||units on a scale||Standard Deviation|Mean
674644|NCT01646255|Secondary|Change in Unified Parkinson’s Disease Rating Scale (UPDRS Part III Motor Examination) During “on” Periods From Baseline to the End of Double-blind Maintenance Period|"The UPDRS Part III (motor subscale) assessment consists of 27 questions, measured on a 5-Point scale (0 to 4). The sum score is calculated as sum of these 27 individual questions. This score ranges from 0 to 108, higher scores denote greater disability.
A subject has been considered “on” when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was 'off' when taking his/her L-dopa, he/she recorded the exact time their status changed to 'on'."|From Baseline (Week 0) to end of Maintenance Period (up to Week 12)|The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement.||units on a scale||Standard Deviation|Mean
674645|NCT01646255|Secondary|Change in Status of the Subject (Off) After Wake-up From Baseline to the End of Double-blind Maintenance Period|"A subject has been considered “off” when he/she began to lose the optimum effects of anti-Parkinson’s medication.
The percentage of days from Baseline to the end of the double-blind Maintenance Period in which the subject woke in the off state is presented below."|From Baseline (Week 0) to end of Maintenance Period (up to Week 12)|The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement.||percentage of days||Standard Deviation|Mean
674646|NCT01646255|Secondary|Change in Status of the Subject (on) After Wake-up Without Troublesome Dyskinesia From Baseline to the End of Double-blind Maintenance Period|"A subject has been considered “on” when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was 'off' when taking his/her L-dopa, he/she recorded the exact time their status changed to 'on'.
The percentage of days from Baseline to the end of the double-blind Maintenance Period in which the subject woke in the on without troublesome dyskinesia” state is presented below."|From Baseline (Week 0) to end of Maintenance Period (up to Week 12)|The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement.||percentage of days||Standard Deviation|Mean
674647|NCT01646255|Secondary|Change in Status of the Subject (on) After Wake-up With Troublesome Dyskinesia From Baseline to the End of Double-blind Maintenance Period|"A subject has been considered “on” when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was 'off' when taking his/her L-dopa, he/she recorded the exact time their status changed to 'on'.
The percentage of days from Baseline to the end of the double-blind Maintenance Period in which the subject woke in the on with troublesome dyskinesia” state is presented below."|From Baseline (Week 0) to end of Maintenance Period (up to Week 12)|The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement.||percentage of days||Standard Deviation|Mean
674648|NCT01646255|Secondary|Change in the Number of “Off” Periods From Baseline to the End of Double-blind Maintenance Period|A subject has been considered “off” when he/she began to lose the optimum effects of anti-Parkinson’s medication.|From Baseline (Week 0) to end of Maintenance Period (up to Week 12)|The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement.||Number of 'off' Periods||Standard Deviation|Mean
674649|NCT01646255|Secondary|Percent Change in Relative Time Spent “on” From Baseline to the End of Double-blind Maintenance Period|"A subject has been considered “on” when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was off when taking his/her L-dopa, he/she recorded the exact time their status changed to on.
Note for percent change calculations: when relative time at Baseline was 0%, the relative Baseline value was assumed to be 0.1 for calculation purposes.
Relative time spent “on” will be calculated in two stages. Each valid daily diary will have an associated relative time “on” calculated as relative time “on” for day = 100*[total absolute time “on” for day/ absolute time awake for day]. Relative time spent on is then calculated by averaging the daily relative time “on” for the valid days of that visit."|From Baseline (Week 0) to end of Maintenance Period (up to Week 12)|The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement.||percent change||Standard Deviation|Mean
674756|NCT01645059|Secondary|Adjuvant Treatment in Primary Breast Cancer: Chemotherapy (Treatment With TAC-Docetaxel, Adriamicine and Cyclophosphamide), Hormonal Therapy Anti-HER Biological Therapy||one day (there is no follow-up, it is a cross-sectional study)|||percentage of participants||95% Confidence Interval|Number
674650|NCT01646255|Secondary|Percent Change in Absolute Time Spent “on” From Baseline to the End of Double-blind Maintenance Period|"A subject has been considered “on” when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was 'off' when taking his/her L-dopa, he/she recorded the exact time their status changed to 'on'.
Note for percent change calculations: when absolute time at Baseline was 0 hours, the absolute Baseline value was assumed to be 1 minute for calculation purposes."|From Baseline (Week 0) to end of Maintenance Period (up to Week 12)|The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement.||percent change||Standard Deviation|Mean
674651|NCT01646255|Secondary|Change in Relative Time Spent “on” From Baseline to the End of Double-blind Maintenance Period|"A subject has been considered “on” when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was off when taking his/her L-dopa, he/she recorded the exact time their status changed to on.
Relative time spent “on” will be calculated in two stages. Each valid daily diary will have an associated relative time “on” calculated as relative time “on” for day = 100*[total absolute time “on” for day/ absolute time awake for day]. Relative time spent on is then calculated by averaging the daily relative time “on” for the valid days of that visit."|From Baseline (Week 0) to end of Maintenance Period (up to Week 12)|The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement.||hours||Standard Deviation|Mean
674652|NCT01646255|Secondary|Change in Absolute Time Spent “on” From Baseline to the End of Double-blind Maintenance Period|"A subject has been considered “on” when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was 'off' when taking his/her L-dopa, he/she recorded the exact time their status changed to 'on'.
Absolute time “on” is defined as the mean number of hours marked “on” during a 24-hour period from all valid daily diary cards."|From Baseline (Week 0) to end of Maintenance Period (up to Week 12)|The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement.||hours||Standard Deviation|Mean
674653|NCT01646255|Secondary|Percent Change in Relative Time Spent “Off” From Baseline to the End of Double-blind Maintenance Period|"A subject has been considered “off” when he/she began to lose the optimum effects of anti-Parkinson’s medication.
Relative time spent “off” will be calculated in two stages. Each valid daily diary will have an associated relative time “off” calculated as relative time “off” for day = 100*[total absolute time “off” for day/ absolute time awake for day]. Relative time spent off is then calculated by averaging the daily relative time “off” for the valid days of that visit."|From Baseline (Week 0) to end of Maintenance Period (up to Week 12)|The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement.||percent change||Standard Deviation|Mean
674654|NCT01646255|Secondary|Percent Change in Absolute Time Spent “Off” From Baseline to the End of Double-blind Maintenance Period|"A subject has been considered “off” when he/she began to lose the optimum effects of anti-Parkinson’s medication.
Absolute time “off” is defined as the mean number of hours marked “off” during a 24-hour period from all valid daily diary cards."|From Baseline (Week 0) to end of Maintenance Period (up to Week 12)|The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement.||percent change||Standard Deviation|Mean
674655|NCT01646255|Secondary|Percentage of Responders From Baseline to the End of the Doubleblind Maintenance Period|A Responder is defined as a subject with an ≥ 30 % decrease in absolute time spent 'off'|From Baseline (Week 0) to end of Maintenance Period (up to Week 12)|The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement.||percentage of participants|||Number
674656|NCT01646255|Primary|Absolute Change in Absolute Time Spent 'Off' From Baseline to the End of Double-blind Maintenance Period|A subject has been considered “off” when he/she began to lose the optimum effects of anti-Parkinson’s medication. A negative mean indicates a reduction of the time off during the conduct of the study|From Baseline (Week 0) to end of Maintenance Period (up to Week 12)|The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement.||hours||Standard Deviation|Mean
675996|NCT01631825|Secondary|Each Item of UPDRS Part 2 (on State)|The percentage of subjects with elevated scores for each item of UPDRS Part 2 (on state). The data at week 52 is shown.|Baseline, up to 54 weeks after dosing.|FAS, LOCF||Percentage of Participants|||Number
674718|NCT01646021|Secondary|Time to Response|Time to response for participants with CR/PR, defined as the interval between the date of randomization and date of initial documentation of response.|Approximately 2.8 years|The Intent ­to ­Treat population included all participants randomized into the study. The N signifies the number of participants responded for this outcome measure.||Months||Full Range|Median
674719|NCT01646021|Secondary|Time-to-Next Treatment|Time to next treatment was measured from the date of randomization to the start date of any anti­lymphoma treatment subsequent to study treatment.|approximately 2.8 years|The Intent­-to­-Treat population included participants randomized into the study.||Months||95% Confidence Interval|Median
674675|NCT01646151|Primary|IOP at Week 12|IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Week 12.|Week 12|All patients with data for this outcome measure||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
674676|NCT01646151|Secondary|Percentage of Patients Who Continue Treatment With Bimatoprost-Containing Eye Drops|Patients who will continue treatment with bimatoprost-containing eye drops after 12 weeks of treatment was assessed as Yes or No.|Week 12|All patients||Percentage of Patients|||Number
674677|NCT01646151|Secondary|Percentage of Patients Who Discontinue Treatment With Bimatoprost-Containing Eye Drops Prior to 12 Weeks of Treatment|Patients who discontinue treatment with bimatoprost-containing eye drops prior to 12 weeks of treatment was assessed as Yes or No.|12 Weeks|All patients||Percentage of Patients|||Number
674678|NCT01646151|Secondary|Physician Assessment of Patient Compliance Compared to Previous Therapy|Physician assessment of patient compliance compared to previous therapy was assessed on a 3-point scale (better, equal, and worse). The numbers of patients in each category are presented.|Week 12|All patients with data for this outcome measure||Patients|||Number
674679|NCT01646151|Secondary|Physician Assessment of Tolerability on a 4-Point Scale|Physician assessment of tolerability was assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented.|Week 12|All patients with data for this outcome measure||Patients|||Number
674680|NCT01646151|Secondary|Patient Assessment of Tolerability on a 4-Point Scale|Patient assessment of tolerability was assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented.|Week 12|All patients with data for this outcome measure||Patients|||Number
674681|NCT01646151|Secondary|Physician Evaluation of IOP Lowering in the Study Eye(s)|IOP is a measurement of the fluid pressure inside the eye. Physicians evaluated IOP compared to the target IOP for each patient's study eye(s). The numbers of eyes in each category are presented.|Week 12|All patients with data for this outcome measure||Eyes|Participants||Number
674682|NCT01646151|Primary|Intraocular Pressure (IOP) at Baseline|IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Baseline.|Baseline|All patients with data for this outcome measure||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
674683|NCT01646138|Primary|Percent MMID|Percent of individuals experiencing mild to moderate influenza infection (MMID, defined as active shedding and symptoms of influenza A) in each dosing group.|67 days after influenza inoculation|Analysis of the subjects who completed the study after receiving a particular dose of Ca/04/2009/H1N1 Vero Grown Challenge Virus.||percentage of participants|||Number
674684|NCT01646125|Secondary|Time to Progression (TTP)|TTP will be compared between treatment arms. The TTP will be based on local investigator assessment per RECIST 1.1|baseline, until disease progression up to 24 months|The data monitoring committee (DMC's) recommendation based on the Interim Analysis (IA) results was to terminate the study early due to futility; collection of efficacy data for assessment was stopped at that time.|||||
674685|NCT01646125|Secondary|Change in Laboratory Paramenters|Changes in hematology and chemistry values, vital signs, electrocardiograms (ECGs), Dose interruptions, reductions and dose intensity.|baseline, until disease progression up to 24 months|The data monitoring committee (DMC's) recommendation based on the Interim Analysis (IA) results was to terminate the study early due to futility; collection of efficacy data for assessment was stopped at that time.|||||
674686|NCT01646125|Secondary|Rate of Adverse Events (AEs)|To evaluate safety and tolerability of AUY922 compared to chemotherapy agents pemetrexed or docetaxel.|baseline, until disease progression up to 24 months|The data monitoring committee (DMC's) recommendation based on the Interim Analysis (IA) results was to terminate the study early due to futility; collection of efficacy data for assessment was stopped at that time.|||||
674687|NCT01646125|Secondary|Duration of Response (DOR)|The DOR will be compared between treatment arms. The DOR will be based on local investigator assessment per RECIST 1.1|baseline, until disease progression up to 24 months|The data monitoring committee (DMC's) recommendation based on the Interim Analysis (IA) results was to terminate the study early due to futility; collection of efficacy data for assessment was stopped at that time.|||||
674688|NCT01646125|Secondary|Time to Response (TRR)|TTR was to compare between treatment arms. The TTR was to be based on local investigator assessment per RECIST 1.1|baseline, until disease progression up to 24 months|The data monitoring committee (DMC's) recommendation based on the Interim Analysis (IA) results was to terminate the study early due to futility; collection of efficacy data for assessment was stopped at that time.|||||
675821|NCT01634243|Secondary|Off Time for Advanced Parkinson's Disease With Concomitant L-dopa Therapy|Mean change (LOCF) from baseline in off time at 12 weeks after dosing.|Baseline, 12 weeks after dosing|Subjects with measurable off time data at baseline and after dosing, LOCF||Hours||Standard Deviation|Mean
674690|NCT01646125|Secondary|Overall Survival (OS)|OS is defined as the time from the date of randomization to date of death due to any cause. If a death has not been observed by the date of analysis cutoff, then OS was to be censored at the last known date patient was alive.|from randomization until death up to death|The data monitoring committee (DMC's) recommendation based on the Interim Analysis (IA) results was to terminate the study early due to futility; collection of efficacy data for assessment was stopped at that time.|||||
674691|NCT01646125|Secondary|Overall Response Rate (ORR)|ORR was to be compared between treatment arms. The ORR was to be based on local investigator assessment per Response Evaluation Criteria In Solid Tumors Criteria 1.1 (RECIST 1.1). Per this criteria for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.This outcome measure was originally planned to be analyzed up to 24 months. The DMC recommendation at the IA was to stop the study for futility. As a result, collection of all the efficacy assessments was stopped at that time.|16 months|The data monitoring committee's (DMC's) recommendation based on the Interim Analysis (IA) results was to terminate the study early due to futility; collection of efficacy data for assessment was stopped at that time.||Participants|||Number
674692|NCT01646125|Primary|Progression Free Survival (PFS)|Compared PFS between the treatment of AUY922 to comparators Pemetrexed or Docetaxel. Progression-free survival (PFS) based on local investigator assessment per RECIST 1.1 was the time from date of randomization/start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient had not had an event, progression-free survival is censored at the date of last adequate tumor assessment. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|16 months|Efficacy analysis set (EAS) compromised of a subset of patients in the FAS who received 2 lines of prior antineoplastic therapy consisting of a platinum-based treatment & an EGFR TKI treatment. The DMC recommendation at Interim analysis was to stop the study for futility. As a result, collection of all efficacy assessments was stopped.||Months||90% Confidence Interval|Median
674693|NCT01646073|Secondary|Change From Baseline in the Short Form 36 (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) [Period B]|Short Form-36 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: physical component summary (PCS) and mental component summary (MCS). The SF-36 consists of 8 subscales. The PCS is represented by 4 subscales: physical function, role limitations due to physical problems, bodily pain, and general health perception. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have choices per item. Summations of item scores of the same subscale give the subscale scores, which were transformed into a range from 0 to 100; zero= worst HRQL, 100=best HRQL. PCS and MCS scores were constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score. The difference from baseline to week 12 in SF-36 PCS and MCS was calculated.|Baseline to Week 24|ITT_B: all participants who received at least 1 dose of study drug in Period B; LOCF: used the completed evaluation from the previous visit within the particular period for efficacy measures assessed to impute missing data at later visits in the same period. Baseline efficacy evaluations were not carried forward.||scores on a scale||Standard Deviation|Mean
674694|NCT01646073|Secondary|Change From Baseline in the Short Form 36 (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) [Period A]|Short Form-36 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: physical component summary (PCS) and mental component summary (MCS). The SF-36 consists of 8 subscales. The PCS is represented by 4 subscales: physical function, role limitations due to physical problems, bodily pain, and general health perception. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have choices per item. Summations of item scores of the same subscale give the subscale scores, which were transformed into a range from 0 to 100; zero= worst HRQL, 100=best HRQL. PCS and MCS scores were constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score. The difference from baseline to week 12 in SF-36 PCS and MCS was calculated.|Baseline to Week 12|ITT_A: all participants that were randomized in Week 0 (Baseline); LOCF: used the completed evaluation from the previous visit within the particular period for efficacy measures assessed to impute missing data at later visits in the same period. Baseline efficacy evaluations were not carried forward.||scores on a scale||Standard Error|Mean
674695|NCT01646073|Secondary|"Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of 0 or 1 [Period B]"|The DLQI measures how much a participant's skin problem affected their life over the last week. The possible range for DLQI was 0 to 30, with a higher score indicating a more impaired quality of life; a decrease in score indicates improvement.|Week 16 and Week 24|ITT_B: all participants who received at least 1 dose of study drug in Period B; NRI: any participant who had a missing value at a specific visit as non-responder for that visit.||percentage of participants|||Number
674696|NCT01646073|Secondary|"Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of 0 or 1 [Period A]"|The DLQI measures how much a subject's skin problem affected their life over the last week. The possible range for DLQI was 0 to 30, with a higher score indicating a more impaired quality of life; a decrease in score indicates improvement.|Baseline, Week 3, and Week 12|ITT_A: all participants that were randomized in Week 0 (Baseline); NRI: any participant who had a missing value at a specific visit as non-responder for that visit.||percentage of participants|||Number
674697|NCT01646073|Secondary|"Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of 0 [Period B]"|The DLQI measures how much a participant's skin problem affected their life over the last week. The possible range for DLQI was 0 to 30, with a higher score indicating a more impaired quality of life; a decrease in score indicates improvement.|Week 16 and Week 24|ITT_B: all participants who received at least 1 dose of study drug in Period B; NRI: any participant who had a missing value at a specific visit as non-responder for that visit.||percentage of participants|||Number
674868|NCT01644396|Other Pre-specified|Change From Baseline in Calcium, Sodium and Potassium|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.||mmol/L||Standard Deviation|Mean
674698|NCT01646073|Secondary|"Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of 0 [Period A]"|The DLQI measures how much a subject's skin problem affected their life over the last week. The possible range for DLQI was 0 to 30, with a higher score indicating a more impaired quality of life; a decrease in score indicates improvement.|Baseline, Week 3, and Week 12|ITT_A: all participants that were randomized in Week 0 (Baseline); NRI: any participant who had a missing value at a specific visit as non-responder for that visit.||percentage of participants|||Number
674699|NCT01646073|Secondary|Percentage of Participants With a Physician's Global Assessment (PGA) of “Clear” or “Minimal” [Period B]|The Physician’s Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant ranging from 'clear' (meaning no signs of plaque) to 'severe.'|Weeks 16, 19, and 24|ITT_B: all participants who received at least 1 dose of study drug in Period B; NRI: any participant who had a missing value at a specific visit as non-responder for that visit.||percentage of participants|||Number
674700|NCT01646073|Secondary|Percentage of Participants With a Physician's Global Assessment (PGA) of “Clear” or “Minimal” [Period A]|The Physician’s Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant ranging from 'clear' (meaning no signs of plaque) to 'severe.'|Baseline and Weeks 3, 7, and 12|ITT_A: all participants that were randomized in Week 0 (Baseline); NRI: any participant who had a missing value at a specific visit as non-responder for that visit.||percentage of participants|||Number
674701|NCT01646073|Secondary|Percentage of Participants With a Physician's Global Assessment (PGA) of “Clear” [Period B]|The Physician’s Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant ranging from 'clear' (meaning no signs of plaque) to 'severe.'|Weeks 16, 19, and 24|ITT_B: all participants who received at least 1 dose of study drug in Period B; NRI: any participant who had a missing value at a specific visit as non-responder for that visit.||percentage of participants|||Number
674702|NCT01646073|Secondary|Percentage of Participants With a Physician's Global Assessment (PGA) of “Clear” [Period A]|The Physician’s Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant ranging from 'clear' (meaning no signs of plaque) to 'severe.'|Baseline and Weeks 3, 7, and 12|ITT_A: all participants that were randomized in Week 0 (Baseline); NRI: any participant who had a missing value at a specific visit as non-responder for that visit.||percentage of participants|||Number
674703|NCT01646073|Secondary|Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 50%, 90%, or 100% Reduction (PASI 50/90/100) Response [Period B]|The percentage of participants with a greater than or equal to 50%, 90%, or 100% reduction (improvement) in Psoriasis Area and Severity Index (PASI 50/90/100). PASI is a composite measure of the level of erythema (redness of the skin), induration (hardening of the skin), and desquamation (peeling of the skin) on 4 sites (head, upper extremities, trunk, and lower extremities), each of which are rated on a 5-point scale from 0 (no symptoms) to 4 (very marked). The possible range for PASI score is 0 to 72, with the highest score representing complete erythroderma of the severest possible degree; a decrease in score indicates improvement.|Weeks 16, 19, and 24|ITT_B: all participants who received at least 1 dose of study drug in Period B; NRI: any participant who had a missing value at a specific visit as non-responder for that visit.||percentage of participants|||Number
674704|NCT01646073|Secondary|Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 50%, 90%, or 100% Reduction (PASI 50/90/100) Response [Period A]|The percentage of participants with a greater than or equal to 50%, 90%, or 100% reduction (improvement) in Psoriasis Area and Severity Index (PASI 50/90/100). PASI is a composite measure of the level of erythema (redness of the skin), induration (hardening of the skin), and desquamation (peeling of the skin) on 4 sites (head, upper extremities, trunk, and lower extremities), each of which are rated on a 5-point scale from 0 (no symptoms) to 4 (very marked). The possible range for PASI score is 0 to 72, with the highest score representing complete erythroderma of the severest possible degree; a decrease in score indicates improvement.|Weeks 3, 7, and 12|ITT_A: all participants that were randomized in Week 0 (Baseline); NRI: any participant who had a missing value at a specific visit as non-responder for that visit.||percentage of participants|||Number
674705|NCT01646073|Secondary|Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score [Period B]|PASI is a composite measure of the level of erythema (redness of the skin), induration (hardening of the skin), and desquamation (peeling of the skin) on 4 sites (head, upper extremities, trunk, and lower extremities), each of which are rated on a 5-point scale from 0 (no symptoms) to 4 (very marked). The possible range for PASI score is 0 to 72, with the highest score representing complete erythroderma of the severest possible degree; a decrease in score indicates improvement.|Baseline to Week 24|ITT_B: all participants who received at least 1 dose of study drug in Period B; LOCF: used the completed evaluation from the previous visit within the particular period for efficacy measures assessed to impute missing data at later visits in the same period. Baseline efficacy evaluations were not carried forward.||percent change||Standard Deviation|Mean
674706|NCT01646073|Secondary|Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score [Period A]|Psoriasis Area and Severity Index (PASI), is a composite measure of the level of erythema (redness of the skin), induration (hardening of the skin), and desquamation (peeling of the skin) on 4 sites (head, upper extremities, trunk, and lower extremities), each of which are rated on a 5-point scale from 0 (no symptoms) to 4 (very marked). The possible range for PASI score is 0 to 72, with the highest score representing complete erythroderma of the severest possible degree; a decrease in score indicates improvement.|Baseline to Week 12|ITT_A: all participants that were randomized in Week 0 (Baseline); Last observation carried forward (LOCF): used the completed evaluation from the previous visit within the particular period for efficacy measures assessed to impute missing data at later visits in the same period. Baseline efficacy evaluations were not carried forward.||Percent change||Standard Error|Mean
674720|NCT01646021|Secondary|Duration of Response|Duration of response (CR or PR), defined as the duration in days from the date of initial response to the date of first documented evidence of progressive disease (or relapse for participants who experience CR during the study) or death.|approximately 2.8 years|The Intent ­to ­Treat population included all participants randomized into the study. The N signifies the number of participants responded for this outcome measure.||Months||95% Confidence Interval|Median
674707|NCT01646073|Secondary|Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 75% Reduction (PASI 75) Response [Period B]|The percentage of participants with a greater than or equal to 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI). PASI is a composite measure of the level of erythema (redness of the skin), induration (hardening of the skin), and desquamation (peeling of the skin) on 4 sites (head, upper extremities, trunk, and lower extremities), each of which are rated on a 5-point scale from 0 (no symptoms) to 4 (very marked). The possible range for PASI score is 0 to 72, with the highest score representing complete erythroderma of the severest possible degree; a decrease in score indicates improvement.|Weeks 16, 19, and 24|Intent to Treat Population B (ITT_B): all participants who received at least 1 dose of study drug in Period B; NRI: any participant who had a missing value at a specific visit as non-responder for that visit.||percentage of participants|||Number
674708|NCT01646073|Secondary|Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 75% Reduction (PASI 75) Response [Period A]|The percentage of participants with a greater than or equal to 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI), other than Week 12. PASI is a composite measure of the level of erythema (redness of the skin), induration (hardening of the skin), and desquamation (peeling of the skin) on 4 sites (head, upper extremities, trunk, and lower extremities), each of which are rated on a 5-point scale from 0 (no symptoms) to 4 (very marked). The possible range for PASI score is 0 to 72, with the highest score representing complete erythroderma of the severest possible degree; a decrease in score indicates improvement.|Weeks 3 and 7|ITT_A: all participants that were randomized in Week 0 (Baseline); NRI: any participant who had a missing value at a specific visit as non-responder for that visit.||percentage of participants|||Number
674709|NCT01646073|Primary|Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 75% Reduction (PASI 75) Response at Week 12|The percentage of participants with a greater than or equal to 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score at Week 12. PASI is a composite measure of the level of erythema (redness of the skin), induration (hardening of the skin), and desquamation (peeling of the skin) on 4 sites (head, upper extremities, trunk, and lower extremities), each of which are rated on a 5-point scale from 0 (no symptoms) to 4 (very marked). The possible range for PASI score is 0 to 72, with the highest score representing complete erythroderma of the severest possible degree; a decrease in score indicates improvement.|Week 12|Intent to Treat Population A (ITT_A): all participants who were randomized at Week 0 (Baseline); Non-responder imputation (NRI): any participant who had a missing value at a specific visit as non-responder for that visit.||percentage of participants|||Number
674710|NCT01646021|Secondary|Days of Hospitalization and Emergency Room Visits Reported Related Medical Resource Utilization Information (MRUI)|Medical resource utilization data associated with medical encounters related to disease was reported for all participants throughout the study.|Approximately upto 28.2 months|The Intent-­to-­Treat population included participants randomized into the study. The n signifies the number of participants analyzed at this time point.||Days||Standard Deviation|Mean
674711|NCT01646021|Secondary|Number of Emergency Room Visits Reported Related Medical Resource Utilization Information (MRUI)|Medical resource utilization data associated with medical encounters related to disease was reported for all participants throughout the study.|Approximately upto 28.2 months|The Intent-to--Treat population included participants randomized into the study. The N signifies the number of participants responded for this outcome measure.||Emergency room visits||Standard Deviation|Mean
674712|NCT01646021|Secondary|Number of Hospitalizations Reported Related Medical Resource Utilization Information (MRUI)|Medical resource utilization data associated with medical encounters related to disease was reported for all participants throughout the study.|Approximately upto 28.2 months|The Intent-­to-­Treat population included participants randomized into the study. The N signifies the number of participants responded for this outcome measure.||Hospitalizations||Standard Deviation|Mean
674713|NCT01646021|Secondary|Extent of Exposure of Time|Extent of exposure is defined as the duration of the treatment administered during the study. Duration of exposure is calculated as the number of months between the start and end of treatment.|Approximately upto 28.2 months|Safety Analyses Set (SAS) population includes all the randomized subjects who received at least 1 dose of study agent (ibrutinib or temsirolimus) during the treatment phase.||Months||Standard Deviation|Mean
674714|NCT01646021|Secondary|Number of Participants With Bio Markers That Alter B-cell Receptor (BCR) Signaling or Activate Alternative Signaling Pathways and to Explore Their Association With Response or Resistance to Ibrutinib||Approximately upto 28.2 months||11/2017||||
674715|NCT01646021|Secondary|Area Under the Plasma Concentration of Ibrutinib During Steady State (AUC-ss)|The AUC-ss is the area under the plasma concentration time curve observed during steady state.|Cycle 1 and 2 (Day 1): Predose, 1, 2, 4 hr postdose; Cycle 3 (day 1): Predose|The pharmacokinetics population was included in the study.||ng*h/mL||Standard Deviation|Mean
674716|NCT01646021|Secondary|The Mean Change From Baseline in Euro QoL Five-Dimension (EQ-5D-5L) Scores for Each Post Baseline Assessment|The EQ-5D is a participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression, using 5 levels (1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and possible total score range -0.594 to 1; higher score indicates a better health state.|Baseline, Cycle 2, 3, 4, 5, 6, 7, 8, 11, 14, 17, 20, 28, 36 and End of treatment|The Intent-­to-­Treat population included participants randomized into the study. The n signifies the number of participants analyzed at this time point.||Units on scale||Standard Deviation|Mean
674717|NCT01646021|Secondary|Time to Worsening in the Lymphoma Sub Scale of Functional Assessment of Cancer Therapy- Lymphoma (FACT-Lym)|Time to worsening in the Lymphoma subscale of the FACT-Lym, defined as the interval from the date of randomization to the start date of worsening. Worsening was defined by a 5-point decrease from baseline. FACT-Lym Lymphoma subscale contains 15 questions, scores from 0 to 4 for each question (higher the worse). Lymphoma subscale score is the total of reverse scores, range 0 to 60.|Approximately 2 years|The Intent-­to-­Treat population included participants randomized into the study.||Weeks||95% Confidence Interval|Median
674723|NCT01646021|Secondary|Overall Response Rate (ORR)|Overall response rate (ORR), defined as the percentage of participants who achieved either CR or PR as best overall response as assessed by Independent Review Committee (IRC) at or prior to initiation of subsequent antineoplastic therapy. Complete Response (CR) = Disappearance of all target lesions; Partial Response (PR)= greater than or equal to 30 percentage decrease in the sum of the longest diameter of target lesions and Overall Response (OR) = CR + PR.|Approximately 28.2 months|The Intent ­to­Treat population included all participants randomized into the study.||Percentage of participants|||Number
674724|NCT01646021|Primary|Progression Free Survival (PFS)|Progression free survival is defined as the duration in months from the date of randomization to the date of disease progression or relapse from CR or death whichever was reported first .|Date of randomization up to disease progression or relapse from CR or death, whichever occurs first (approximately upto 28.2 months)|The Intent ­to ­Treat population included all participants randomized into the study.||Months||95% Confidence Interval|Median
674725|NCT01645735|Other Pre-specified|Safety Evaluation|Adverse events (AEs), serious adverse events (SAEs), deaths, discontinuation due to AEs|Baseline (Day 0) to Day 49|Safety Population: all randomized subjects who received any amount of IV study drug||participants|||Number
674726|NCT01645735|Other Pre-specified|Microbiological Outcomes by Baseline Pathogen at TOC in the Microbiological Modified Intent-to-Treat (mMITT) Population|An overall microbiological outcome was derived based on the subject’s baseline pathogen. As no follow-up specimens were collected at the TOC visit for any subjects, all microbiological outcomes were derived based strictly on clinical outcomes, as either presumed eradication (ie, source specimen was not available to culture and the subject was assessed as clinical cure) , presumed persistence (ie, source specimen was not available to culture and the subject was assessed as a clinical failure), or indeterminate (ie, source specimen was not available to culture and the subject’s clinical response was assessed as indeterminate).|Test of Cure, an average of 3 weeks|mMITT Population: a subset of the MITT Population, including subjects for whom at least 1 typical bacterial pathogen has been identified from an adequate microbiological specimen at baseline||participants|||Number
674727|NCT01645735|Primary|Clinical Outcome at Test of Cure (TOC) in the MITT Population|"An assessment of clinical outcome was made by the Investigator at TOC. The clinical outcome categories were:
Cure: Resolution of all acute signs and symptoms of CABP or improvement to such an extent that no further antimicrobial therapy was required
Failure: Subjects who meet either of the following criteria:
Incomplete resolution or worsening of CABP signs and symptoms or development of new CABP signs or symptoms requiring alternative nonstudy antimicrobial therapy
Death in which CABP is contributory
Indeterminate: Study data are not available for evaluation of efficacy for any reason, including:
Death in which CABP is clearly noncontributory
Lost to follow-up
Extenuating circumstances precluding classification as a cure or failure
A favorable clinical outcome at Test-of Cure (TOC) was clinical cure."|Test of Cure, an average of 3 weeks|MITT Population: all randomized subjects who receive any amount of IV study drug and who have a confirmed diagnosis of CABP with risk factors for MRSA (excluding those that have a sole atypical pathogen)||participants|||Number
674728|NCT01645735|Primary|Clinical Response at Study Day 4 in the Modified Intent-to-Treat (MITT) Population|"Clinical response was defined as meeting all of the following criteria:
Symptom Improvement - Improvement in at least 2 and no worsening of any of the following symptoms compared to baseline:
Cough
Dyspnea
Sputum production
Chest pain
Clinical Stability (per Infectious Diseases Society of America/American Thoracic Society (IDSA/ATS) guidelines; Mandell et al, 2007):
Temperature ≤ 37.8°C
Heart rate ≤ 100 beats/min
Respiratory rate ≤ 24 breaths/min
Systolic blood pressure ≥ 90 mmHg
Oxygen saturation ≥ 90%
Confusion/disorientation absent"|Study Day 4|MITT Population: all randomized subjects who receive any amount of IV study drug and who have a confirmed diagnosis of Community-Acquired Bacterial Pneumonia (CABP) with risk factors for Methicillin-Resistant Staphylococcus aureus (MRSA) (excluding those that have a sole atypical pathogen)||participants|||Number
674729|NCT01645709|Secondary|Number of Subjects With Adverse Events|Compare the safety of IA verapamil versus IA placebo using adverse events (AEs) as a comparator|13 weeks||||||
674730|NCT01645709|Secondary|Compare Efficacy of Verapamil to Placebo Compared to Baseline|"To compare the efficacy of IA verapamil and IA placebo using change from baseline in the following:
• Rescue medication use"|13 weeks||||||
674731|NCT01645709|Secondary|Compare Efficacy of Verapamil to Placebo Compared to Baseline|"To compare the efficacy of IA verapamil and IA placebo using change from baseline in the following:
• Patient Global Impression of Change (PGIC)"|13 weeks||||||
674732|NCT01645709|Secondary|Compare Efficacy of Verapamil to Placebo Compared to Baseline|"To compare the efficacy of IA verapamil and IA placebo using change from baseline in the following:
• Response rate"|13 weeks||||||
674733|NCT01645709|Secondary|Compare Efficacy of Verapamil to Placebo Compared to Baseline|"To compare the efficacy of IA verapamil and IA placebo using change from baseline in the following:
• Difference in the current in-clinic pain intensity using the 0-10 NRS before and after exercise at each visit"|13 weeks||||||
674734|NCT01645709|Secondary|Compare Efficacy of Verapamil to Placebo Compared to Baseline|"To compare the efficacy of IA verapamil and IA placebo using change from baseline in the following:
• In-clinic 24-hour recall pain intensity using the 0-10 numerical rating scale (NRS) at each visit"|13 weeks||||||
674735|NCT01645709|Secondary|Compare Efficacy of Verapamil to Placebo Compared to Baseline|"To compare the efficacy of IA verapamil and IA placebo using change from baseline in the following:
• WOMAC pain subscale as measured from 2 to 12 weeks post-treatment using an AUC approach"|13 weeks||||||
674736|NCT01645709|Secondary|Compare Efficacy of Verapamil to Placebo Compared to Baseline|"To compare the efficacy of IA verapamil and IA placebo using change from baseline in the following:
• WOMAC total and subscale scores for pain, function, and stiffness at each visit"|13 weeks||||||
674737|NCT01645709|Primary|Compare Efficacy of Verapmil vs Placebo at Week 4|To compare the efficacy of IA verapamil versus IA placebo for pain relief using the Western Ontario and McMaster Universities Arthritis Index (WOMAC) at week 4.|4 weeks||||||
674804|NCT01644617|Secondary|HDM-specific Immunoglobulin G4 (IgG4) Levels at Week 8|D. pteronyssinus and D. farinae serum IgG4 levels were measured using the Immunocap® assay at Week 8. IgG4 levels were expressed in Log 10 scale milligrams/Liter (mg/L). Analysis was based on the ANOVA model with treatment as the fixed effect and reported as mean IgG4 with a standard deviation.|Week 8|Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint||Log 10 mg/L||Standard Deviation|Mean
674738|NCT01645280|Secondary|Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 28|The Health Assessment Questionnaire-Disability Index (HAQ-DI): participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline and Week 28|The m-ITT included participants who received at least 1 (partial or complete) dose of study agent. For early escape, data at or prior to Week 16 were carried forward through Week 28.||units on scale||Standard Error|Least Squares Mean
674739|NCT01645280|Secondary|Percentage of Participants With American College of Rheumatology 20 (ACR 20) Response at Week 12|The ACR 20 responders are participants with at least 20 percent (%) improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 2) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 3) Physician's Global Assessment of Disease Activity-Visual Analog Scale, 4) Patient’s Assessment of Physical Function as measured by Health Assessment Questionnaire-Disability Index (HAQ-DI), 5) C-reactive Protein (CRP).|Week 12|The m-ITT population included participants who received at least 1 (partial or complete) dose of study agent.||percentage of participants|||Number
674740|NCT01645280|Secondary|Change From Baseline in Disease Activity Index Score 28 (DAS28; Using C-reactive Protein [CRP]) Score at Week 28|The DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, CRP (mG/L) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|From Baseline to Week 28|The modified-ITT population included participants who received at least 1 (partial or complete) dose of study agent. For early escape, data at or prior to Week 16 were carried forward through Week 28.||units on scale||Standard Error|Least Squares Mean
674741|NCT01645280|Primary|Percentage of Participants With American College of Rheumatology 20 (ACR 20) Response at Week 28|The ACR 20 responders are participants with at least 20 percent (%) improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) patient's assessment of arthritis pain-visual analog scale, 2) patient's global assessment of disease activity-visual analog scale, 3) physician's global assessment of disease activity-visual analog scale, 4) patient’s assessment of physical function as measured by health assessment questionnaire-disability index (HAQ-Di), 5) C-reactive protein (CRP).|Week 28|The intent-to-treat (ITT) population included all randomized participants. For early escape, data at or prior to Week 16 were carried forward through Week 28.||percentage of participants|||Number
674742|NCT01645176|Primary|Change in Synovitis|"MRI readings performed independently by two musculoskeletal radiologists, using a semi-quantitative scoring system based on MRI assessment of knee OASynovitis scored using axial & sagittal CE-MRI sequence, while effusion & bone marrow lesions were scored using non-CE-MRI sequences of parent study.
Synovitis defined as enhancing thickened synovium (>2 mm) & was evaluated at nine sites of joint-medial & lateral parapatellar recess, suprapateller, infrapatellar, intercondylar, medial & lateral perimeniscal, & adjacent to anterior & posterior cruciate ligaments (ACL/PCL) in all subjects. Synovial thickness was scored semi-quantitatively based on maximal thickness in any slice at each site as follows: grade 0 if <2mm, grade 1 if 2-4 mm & grade 2 if >4mm. For assessment of whole knee synovitis scores of all sites were summed and categorized: 0-4 normal or equivocal synovitis; 5-8 mild synovitis; 9-12 moderate synovitis & >/= 13 severe synovitis."|baseline and 16 weeks|Participants with osteoarthritis of knee||units on a scale||Standard Deviation|Mean
674743|NCT01645111|Primary|Time to Achieve Target MAP|The time between start of clevidipine infusion and patient reaching target mean arterial pressure (MAP) at 55-65 mmHg|First 30 minutes of infusion|||minutes||Standard Deviation|Mean
674744|NCT01645098|Secondary|EtCO2 Change After Dexmedetomidine Loading Dose|Change in end-tidal carbon dioxide from baseline measurement to immediately post dexmedetomidine infusion.|Baseline to immediately post dexmedetomidine infusion.|||mmHg||Standard Deviation|Mean
674745|NCT01645098|Secondary|Oxygen Saturation Change After Dexmedetomidine Loading Dose|Change in oxygen saturation from baseline measurement to immediately post dexmedetomidine infusion.|Baseline to immediately post dexmedetomidine infusion.|||percentage of oxygen||Standard Deviation|Mean
674746|NCT01645098|Secondary|Mean Arterial Pressure (MAP) Change After Dexmedetomidine Loading Dose|Change in MAP from baseline measurement to immediately post dexmedetomidine infusion measured via blood pressure cuff.|Baseline to immediately post dexmedetomidine infusion.|||mmHg||Standard Deviation|Mean
674747|NCT01645098|Secondary|Heart Rate Change After Dexmedetomidine Loading Dose|Difference in heart rate from baseline to immediately following infusion of dexmedetomidine loading dose.|Baseline to immediately post dexmedetomidine infusion.|||BPM||Standard Deviation|Mean
674748|NCT01645098|Primary|Time to Sedation Score of 3-4|The depth of sedation was judged using the University of Michigan Sedation Scale (UMSS). The score ranges from zero, awake and alert, to four, unarousable. A score of three, deeply sedated, or more was considered to be an appropriate level of sedation for the procedure.|Immediately prior to incision|||minutes||Standard Deviation|Mean
674749|NCT01645059|Secondary|Disseminated Breast Cancer Treatment-Smoking|Analyse disseminated Breast Cancer treatment and clinical profile (Smoking)|one day (there is no follow-up, it is a cross-sectional study)|||percentage of smoking participants|||Number
674750|NCT01645059|Secondary|Disseminated Breast Cancer Treatment-physical Activity|Analyse disseminated Breast Cancer treatment and clinical profile (physical activity)|one day (there is no follow-up, it is a cross-sectional study)|||percentage of patients physical activity|||Number
674751|NCT01645059|Secondary|Disseminated Breast Cancer Treatment-Age|Analyse disseminated Breast Cancer treatment and clinical profile (age)|one day (there is no follow-up, it is a cross-sectional study)|||years||Standard Deviation|Mean
674752|NCT01645059|Secondary|Adjuvant Treatment-Node Affectation|"Adjuvant treatment and clinical profile (Node affectation)
The patients analysed in this outcome are patients initially diagnosed with localized breast cáncer (N=66)"|one day (there is no follow-up, it is a cross-sectional study)|||percentage of patients node affectation|||Number
674757|NCT01645059|Primary|The Patient Clinical Profile (General Clinical Data and Breast Cancer Characteristics)|General clinical data: age, weigh, height, Perfomance Status (ECOG Eastern Cooperative Oncology Group, runs from 0 to 5, with 0 denoting perfect health and 5 death), Breast cancer characteristics: familiar history of breast cancer, initial diagnostic (localized or disseminated), age at diagnostic, TNM (tumor node metástasis), tumor size, node involvement, primary tumor surgery, HER2 overexpression, histological Classification (grades I, II and III,determines the urgency and aggressiveness of treatment, as the higher grades do tend to correspond to poorer survival rates and prognosis), time from the primary breast cancer to distant relapse, description and localization of metastasis|1 day (there is no follow-up, it is a cross-sectional study)|||percentage of participants||95% Confidence Interval|Number
674758|NCT01644734|Secondary|Change in the Total CAT Score (Value Baseline Minus 3 Months)|The change represents the value at baseline minus the value after 3 months. The total CAT score ranges from 0 to 40 where 0 represents no symptoms and 40 very bad symptoms. Therefore, a positive value for the change in the total CAT score means an improvement.|Baseline, 3 months|Patients from FAS||units on a scale||Standard Deviation|Mean
674759|NCT01644734|Primary|Number of Patients Maintaining or Improving Their Health Status|The health status was measured by the total COPD Assessment Test (CAT) score at baseline and at the end of the observation period after app. 3 months (visit 3). Therefore, the total CAT score at baseline and at Visit 3 was calculated by adding up the scores of the single questions of the CAT questionnaire. In the case of one or more missing items the total score was not determined for the specific visit. The health status is considered to be maintained or improved if the change in the total CAT score from baseline at Visit 3 is ≥0.|Baseline, 3 months|Patients from the Full Analysis Set (FAS) which includes all patients in the treated set and who have valid CAT questionnaire results both at baseline and at visit 3.||participants|||Number
674760|NCT01644695|Secondary|Intra and Post-Operative Complications|Record of intra and post operative complications resulting from BARS(bony anchoring reinforcement system) procedure including but not limited to scarring, pain, numbness, intra-abdominal injury, bleeding, death, infection, anesthesia complications, and need for further surgery.|ongoing, average 2.4 years|There were 6 instances of wound dehiscence. There were 2 instances each of infection, necrosis, DVT,hematoma, and neuroma. There was 1 instance each of cellulitis, bowel obstruction, entrapped nerve, and temporary numbness. Further surgery was required 7 times, of which 3 included partial removal of the mesh. 27 complications in total.||participants|||Number
674761|NCT01644695|Primary|Recurrence Rate|Evidence of complex incisional hernia recurrence after treatment with BARS procedure.|ongoing, average 2.4 years|Subjects were chosen per protocol according to their candidacy for the BARS procedure. All patients were monitored closely following the operation.||participants|||Number
674762|NCT01644643|Secondary|Plasma Concentrations for Ceftazidime and Avibactam — cUTI in PK Analysis Set|Blood samples were taken on Day 3 for ceftazidime and avibactam plasma concentration.|Anytime within 15 minutes prior to or after stopping study drug, anytime between 30 to 90 minutes after stopping study drug, anytime between 300 to 360 minutes after stopping study drug|PK Analysis set||NG/ML||Full Range|Geometric Mean
674763|NCT01644643|Secondary|Plasma Concentrations for Ceftazidime and Avibactam — cIAI in PK Analysis Set|Blood samples were taken on Day 3 for ceftazidime and avibactam plasma concentration.|Anytime within 15 minutes prior to or after stopping study drug, anytime between 30 to 90 minutes after stopping study drug, anytime between 300 to 360 minutes after stopping study drug|PK Analysis set||NG/ML||Full Range|Geometric Mean
674764|NCT01644643|Secondary|The 28 Days All Cause Mortality Rate in EME at TOC Analysis Set|Proportion of patients with Day 28 all-cause mortality in EME at TOC analysis set. The death in the cIAI patient were reviewed independently by the SRP Chair.|From first infusion to Day 28|Extended microbiologically evaluable at TOC||Participant|||Number
674765|NCT01644643|Secondary|The 28 Days All Cause Mortality Rate in mMITT Analysis Set|Proportion of patients with Day 28 all-cause mortality in mMITT analysis set. The death in the cIAI patient were reviewed independently by the SRP Chair.|From first infusion to Day 28|Microbiological modified intent to treat||Participant|||Number
674766|NCT01644643|Secondary|The Reason for Treatment Change/Discontinuation in mMITT Analysis Set|Proportion of patients in the mMITT analysis set for whom the assigned study treatment was changed, discontinued, or interrupted. Creatinine clearance (CrCl)|From first infusion to last infusion of study therapy. Duration of study therapy was 5 to 21 days.|Microbiological modified intent to treat||Participant|||Number
674767|NCT01644643|Secondary|Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set|Proportion of patients with a favorable per-pathogen microbiological response for pathogens (>=10% of frequncy in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population). For E.coli, MIC available values are: <=0.008, 0.03, 0.06, 0.12, 0.25, 0.5, 1, 2, 8. For K. pneumoniae, MIC available values are: 0.06, 0.12, 0.25, 0.5, 1, 2, 4, >32. For P. aeruginosa, MIC available values are: 2, 4, 8, 16, 32, >32.|6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.|Extended microbiologically evaluable at TOC||Participant|||Number
674768|NCT01644643|Secondary|Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set|Proportion of patients with a favorable per-pathogen microbiological response for pathogens (>=10% of frequncy in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population). For E.coli, MIC available values are: <=0.008, 0.03, 0.06, 0.12, 0.25, 0.5, 1, 2, 8. For K. pneumoniae, MIC available values are: 0.06, 0.12, 0.25, 0.5, 1, 2, 4, 32, >32. For P. aeruginosa, MIC available values are: 2, 4, 8, 16, 32, >32.|6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.|Microbiological modified intent to treat||Participant|||Number
674769|NCT01644643|Secondary|Per-pathogen Microbiological Response of Gram-negative Pathogen at FU2 in EME at FU2 Analysis Set|Proportion of patients with a favorable per-pathogen microbiological response for pathogens (>=10% of frequncy in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population).|At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization|Extended microbiologically evaluable at FU2||Participant|||Number
674770|NCT01644643|Secondary|Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in EME at FU1 Analysis Set|Proportion of patients with a favorable per-pathogen microbiological response for pathogens (>=10% of frequncy in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population).|cIAI: 27-37 calendar days from randomization/cUTI: 20-27 calendar days from randomization|Extended microbiologically evaluable at FU1||Participant|||Number
674771|NCT01644643|Secondary|Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in EME at TOC Analysis Set|Proportion of patients with a favorable per-pathogen microbiological response for pathogens (>=10% of frequncy in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population).|6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.|Extended microbiologically evaluable at TOC||Participant|||Number
674772|NCT01644643|Secondary|Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in EME at EOT Analysis Set|Proportion of patients with a favorable per-pathogen microbiological response for pathogens (>=10% of frequncy in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population).|28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days.|Extended microbiologically evaluable at EOT||Participant|||Number
674773|NCT01644643|Secondary|Per-pathogen Microbiological Response of Gram-negative Pathogen at FU2 in mMITT Analysis Set|Proportion of patients with a favorable per-pathogen microbiological response for pathogens (>=10% of frequncy in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population).|At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization|Microbiological modified intent to treat||Participant|||Number
674774|NCT01644643|Secondary|Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in mMITT Analysis Set|Proportion of patients with a favorable per-pathogen microbiological response for pathogens (>=10% of frequency in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population).|cIAI: 27-37 calendar days from randomization/cUTI: 20-27 calendar days from randomization|Microbiological modified intent to treat||Participant|||Number
674775|NCT01644643|Secondary|Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in mMITT Analysis Set|Proportion of patients with a favorable per-pathogen microbiological response for pathogens (>=10% of frequency in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population).|6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.|Microbiological modified intent to treat||Participant|||Number
674776|NCT01644643|Secondary|Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in mMITT Analysis Set|Proportion of patients with a favorable per-pathogen microbiological response for pathogens (>=10% of frequency in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population).|28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days.|Microbiological modified intent to treat||Participant|||Number
674822|NCT01644500|Secondary|Change From Baseline in Heart Rate From ECG at 26 Weeks||Baseline, 26 Weeks|All participants who were randomized, received at least 1 dose of study drug, and had evaluable ECG data.||bpm||Standard Deviation|Mean
674869|NCT01644396|Other Pre-specified|Change From Baseline in Inorganic Phosphate|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.||mmol/L||Standard Deviation|Mean
674777|NCT01644643|Secondary|Per-patient Microbiological Response at FU2 in EME at FU2 Analysis Set|Microbiological responses as per the protocoled criteria: responses other than “indeterminate” were classified as “favorable” or “unfavorable.” Favorable microbiological response assessments included “eradication” and “presumed eradication.” Unfavorable microbiological response assessments included “persistence,” “persistence with increasing minimum inhibitory concentration (MIC),” and “presumed persistence.” Indeterminate microbiologic response assessments included cIAI patients where the clinical response was changed to indeterminate due to a Surgical Review Panel assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).|At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization|Extended microbiologically evaluable at FU2||Participant|||Number
674778|NCT01644643|Secondary|Per-patient Microbiological Response at FU1 in EME at FU1 Analysis Set|Microbiological responses as per the protocoled criteria: responses other than “indeterminate” were classified as “favorable” or “unfavorable.” Favorable microbiological response assessments included “eradication” and “presumed eradication.” Unfavorable microbiological response assessments included “persistence,” “persistence with increasing minimum inhibitory concentration (MIC),” and “presumed persistence.” Indeterminate microbiologic response assessments included cIAI patients where the clinical response was changed to indeterminate due to a Surgical Review Panel assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).|cUTI: 20-27 calendar days from randomization/cIAI: 27-37 calendar days from randomization|Extended microbiologically evaluable at FU1||Participant|||Number
674779|NCT01644643|Secondary|Per-patient Microbiological Response at TOC in EME at TOC Analysis Set|Microbiological responses as per the protocoled criteria: responses other than “indeterminate” were classified as “favorable” or “unfavorable.” Favorable microbiological response assessments included “eradication” and “presumed eradication.” Unfavorable microbiological response assessments included “persistence,” “persistence with increasing minimum inhibitory concentration (MIC),” and “presumed persistence.” Indeterminate microbiologic response assessments included cIAI patients where the clinical response was changed to indeterminate due to a Surgical Review Panel assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).|6-12 days after last infusion of study therapy.Duration of study therapy was 5 to 21 days.|Extended microbiologically evaluable at TOC||Participant|||Number
674780|NCT01644643|Secondary|Per-patient Microbiological Response at EOT in EME at EOT Analysis Set|Microbiological responses as per the protocoled criteria: responses other than “indeterminate” were classified as “favorable” or “unfavorable.” Favorable microbiological response assessments included “eradication” and “presumed eradication.” Unfavorable microbiological response assessments included “persistence,” “persistence with increasing minimum inhibitory concentration (MIC),” and “presumed persistence.” Indeterminate microbiologic response assessments included cIAI patients where the clinical response was changed to indeterminate due to a Surgical Review Panel assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).|28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days.|Extended microbiologically evaluable at EOT||Participant|||Number
674781|NCT01644643|Secondary|Per-patient Microbiological Response at FU2 in mMITT Analysis Set|Microbiological responses as per the protocoled criteria: responses other than “indeterminate” were classified as “favorable” or “unfavorable.” Favorable microbiological response assessments included “eradication” and “presumed eradication.” Unfavorable microbiological response assessments included “persistence,” “persistence with increasing minimum inhibitory concentration (MIC),” and “presumed persistence.” Indeterminate microbiologic response assessments included cIAI patients where the clinical response was changed to indeterminate due to a Surgical Review Panel assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).|At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization|Microbiological modified intent to treat||Participant|||Number
674782|NCT01644643|Secondary|Per-patient Microbiological Response at FU1 in mMITT Analysis Set|Microbiological responses as per the protocoled criteria: responses other than “indeterminate” were classified as “favorable” or “unfavorable.” Favorable microbiological response assessments included “eradication” and “presumed eradication.” Unfavorable microbiological response assessments included “persistence,” “persistence with increasing minimum inhibitory concentration (MIC),” and “presumed persistence.” Indeterminate microbiologic response assessments included cIAI patients where the clinical response was changed to indeterminate due to a Surgical Review Panel assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).|cUTI: 20-27 calendar days from randomization/cIAI: 27-37 calendar days from randomization|Microbiological modified intent to treat||Participant|||Number
674783|NCT01644643|Secondary|Per-patient Microbiological Response at TOC in mMITT Analysis Set|Microbiological responses as per the protocoled criteria: responses other than “indeterminate” were classified as “favorable” or “unfavorable.” Favorable microbiological response assessments included “eradication” and “presumed eradication.” Unfavorable microbiological response assessments included “persistence,” “persistence with increasing minimum inhibitory concentration (MIC),” and “presumed persistence.” Indeterminate microbiologic response assessments included cIAI patients where the clinical response was changed to indeterminate due to a Surgical Review Panel assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).|6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.|Microbiological modified intent to treat||Participant|||Number
674866|NCT01644396|Other Pre-specified|Change From Baseline in Albumin|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.||g/L||Standard Deviation|Mean
674784|NCT01644643|Secondary|Per-patient Microbiological Response at EOT in mMITT Analysis Set|Microbiological responses as per the protocoled criteria: responses other than “indeterminate” were classified as “favorable” or “unfavorable.” Favorable microbiological response assessments included “eradication” and “presumed eradication.” Unfavorable microbiological response assessments included “persistence,” “persistence with increasing minimum inhibitory concentration (MIC),” and “presumed persistence.” Indeterminate microbiologic response assessments included cIAI patients where the clinical response was changed to indeterminate due to a Surgical Review Panel assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).|28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days.|Microbiological modified intent to treat||Participant|||Number
674785|NCT01644643|Secondary|Clinical Cure at FU2 by Previously Failed Treatment Class in EME at FU2 Analysis Set|Proportion of patients with clinical cure at FU2 visit by previously failed treatment class in EME at FU2 analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary.|At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization|Extended microbiologically evaluable at FU2||Participant|||Number
674786|NCT01644643|Secondary|Clinical Cure at FU1 by Previously Failed Treatment Class in EME at FU1 Analysis Set|Proportion of patients with clinical cure at FU1 visit by previously failed treatment class in EME at FU1 analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).|cIAI: 27-37 calendar days from randomization/cUTI: 20-27 calendar days from randomization|Extended microbiologically evaluable at FU1||Participant|||Number
674787|NCT01644643|Secondary|Clinical Cure at TOC by Previously Failed Treatment Class in EME at TOC Analysis Set|Proportion of patients with clinical cure at TOC visit by previously failed treatment class in EME at TOC analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).|6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.|Extended microbiologically evaluable at TOC||Participant|||Number
674788|NCT01644643|Secondary|Clinical Cure at EOT by Previously Failed Treatment Class in EME at EOT Analysis Set|Proportion of patients with clinical cure at EOT visit by previously failed treatment class in EME at EOT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).|28 hours after completion of last infusion of study therapy.Duration of study therapy was 5 to 21 days.|Extended microbiologically evaluable at EOT||Participant|||Number
674789|NCT01644643|Secondary|Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set|Proportion of patients with clinical cure at TOC visit by previously failed treatment class in the mMITT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).|6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.|Microbiological modified intent to treat||Participant|||Number
674790|NCT01644643|Secondary|Clinical Cure at TOC by Baseline Gram-negative Pathogen in EME at TOC Analysis Set|Proportion of patients with clinical cure at TOC visit by baseline Gram-negative pathogen (>=10% of frequency in the combined cIAI and cUTI patients) in EME at TOC analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).|6-12 days after last infusion of study therapy.Duration of study therapy was 5 to 21 days.|Extended microbiologically evaluable at TOC||Participant|||Number
674791|NCT01644643|Secondary|Clinical Cure at TOC by Baseline Gram-negative Pathogen in mMITT Analysis Set|Proportion of patients with clinical cure at TOC visit by baseline pathogen (>=10% of frequency in the combined cIAI and cUTI patients) in the mMITT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).|6-12 days after last infusion of study therapy.Duration of study therapy was 5 to 21 days.|Microbiological modified intent to treat||Participant|||Number
674792|NCT01644643|Secondary|Clinical Response at FU2 in EME at FU2 Analysis Set|Proportion of patients with clinical cure at the FU2 visit in EME at FU2 analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary.|At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization|Extended Microbiological Evaluable at FU2 analysis set.||Participant|||Number
674793|NCT01644643|Secondary|Clinical Response at FU1 in EME at FU1 Analysis Set.|Proportion of patients with clinical cure at the FU1 visit in EME at FU1 analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).|cIAI: 27-37 calendar days from randomization/cUTI: 20-27 calendar days from randomization|Extended Microbiological Evaluable at FU1 analysis set.||Participant|||Number
674794|NCT01644643|Secondary|Clinical Response at TOC in EME at TOC Analysis Set.|Proportion of patients with clinical cure at the TOC visit in the EME at TOC analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).|6-12 days after last infusion of study therapy.Duration of study therapy was 5 to 21 days.|Extended Microbiological Evaluable at TOC analysis set.||Participant|||Number
674795|NCT01644643|Secondary|Clinical Response at EOT in Extended Microbiologically Evaluable (EME) at EOT Analysis Set.|Proportion of patients with clinical cure at the EOT visit in the EME at EOT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).|28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days.|Extended Microbiological Evaluable at EOT analysis set.||Participant|||Number
674796|NCT01644643|Secondary|Clinical Response at Follow-up 2 (FU2) in mMITT Analysis Set|Proportion of patients with clinical cure at the FU2 visit in the mMITT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).|At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization|Microbiological modified intent to treat||Participant|||Number
674797|NCT01644643|Secondary|Clinical Response at Follow-up 1 (FU1) in mMITT Analysis Set|Proportion of patients with clinical cure at the FU1 visit in the mMITT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).|cIAI: 27-37 calendar days from randomization/cUTI: 20-27 calendar days from randomization|Microbiological modified intent to treat||Participant|||Number
674798|NCT01644643|Secondary|Clinical Response at End of Treatment (EOT) in mMITT Analysis Set.|Proportion of patients with clinical cure at the EOT visit in the mMITT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).|28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days.|Microbiological modified intent to treat||Participant|||Number
674799|NCT01644643|Primary|Clinical Response at Test of Cure (TOC) in Microbiological Modified Intent-to-treat (mMITT) Analysis Set|Proportion of patients with clinical cure at the TOC visit in the mMITT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).|6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.|Microbiological modified intent to treat||Participant|||Number
674800|NCT01644617|Secondary|Percentage of Participants Who Discontinued Study Drug Due to an AE|The percentage of participants who had study treatment stopped due to an AE. Discontinuations were reported for all randomized participants who received ≥1 dose of study treatment.|From first dose to last dose of treatment (Up to 24 weeks)|All Participants as Treated including all randomized participants who received at least one dose of study treatment||Percentage of Participants|||Number
674801|NCT01644617|Secondary|Percentage of Participants Who Experienced At Least One Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol-specified procedure, whether or not considered related to the medicinal product/protocol-specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE. A serious adverse event (SAE) was an AE that resulted in death, was life threatening, resulted in persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a cancer, was associated with an overdose, was another important medical event.|From first dose to last dose of treatment plus 2 weeks of follow-up (Up to 26 weeks)|All Participants as Treated including all randomized participants who received at least one dose of study treatment||Percentage of participants|||Number
674802|NCT01644617|Secondary|Change From Baseline in HDM-specific IgG4 Levels at Week 8|D. pteronyssinus and D. farinae serum IgG4 levels were measured using the Immunocap® assay at baseline and Week 8. IgG4 levels were expressed in Log 10 scale mg/L. Mean Week 8 IgG4 levels were compared to the mean IgG4 levels at baseline. Analysis was based on the ANOVA model with treatment as the fixed effect and reported as a least squares mean with 95% confidence interval.|Time Frame: Baseline and Week 8|Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint||Log 10 mg/L||95% Confidence Interval|Least Squares Mean
674803|NCT01644617|Secondary|Change From Baseline in HDM-specific IgE Levels at Week 8|D. pteronyssinus and D. farinae serum IgE levels were measured using the Immunocap® assay at baseline and Week 8. IgE levels were expressed in Log 10 scale kU/L. Mean Week 8 IgE levels were compared to the mean IgE levels at baseline. Analysis was based on the ANOVA model with treatment as the fixed effect and reported as a least squares mean with 95% confidence interval.|Baseline and Week 8|Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint||Log 10 kU/L||95% Confidence Interval|Least Squares Mean
674805|NCT01644617|Secondary|HDM-specific Immunoglobulin E (IgE) Levels at Week 8|Dermatophagoides pteronyssinus (D. pteronyssinus) and Dermatophagoides farinae (D. farinae) serum IgE levels were measured using the Immunocap® assay at Week 8. IgE levels were expressed in Log 10 scale kilo units/Liter (kU/L). Analysis was based on the analysis of variance parametric (ANOVA) model with treatment as the fixed effect and reported as mean IgE with a standard deviation.|Week 8|Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint||Log 10 kU/L||Standard Deviation|Mean
674806|NCT01644617|Secondary|Average TOSS During EEC Challenge Session at Week 8|The average total TOSS included the evaluation of 2 ocular symptoms: gritty/feeling/red/itchy eyes and watery eyes. The endpoint was based on participant diary entries over the last 4 hours of the EEC challenge session at Week 8. TOSS was the total of scores for the 2 ocular symptoms, each scored on a 4-point rating scale (0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms). The total TOSS ranged from 0 to 6 points. The Week 8 TOSS was analyzed using the ANCOVA model with treatment and baseline TOSS as covariates and expressed as a least squares mean with 95% confidence interval. A decrease in TOSS for participants receiving either dose of MK-8237 compared to placebo indicated an improvement in symptoms.|Week 8|Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint||Score on a Scale||95% Confidence Interval|Least Squares Mean
674807|NCT01644617|Secondary|Average TOSS During EEC Challenge Session at Week 16|The average total TOSS included the evaluation of 2 ocular symptoms: gritty/feeling/red/itchy eyes and watery eyes. The endpoint was based on participant diary entries over the last 4 hours of the EEC challenge session at Week 16. TOSS was the total of scores for the 2 ocular symptoms, each scored on a 4-point rating scale (0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms). The total TOSS ranged from 0 to 6 points. The Week 16 TOSS was analyzed using the ANCOVA model with treatment and baseline TOSS as covariates and expressed as a least squares mean with 95% confidence interval. A decrease in TOSS for participants receiving either dose of MK-8237 compared to placebo indicated an improvement in symptoms.|Week 16|Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint||Score on a Scale||95% Confidence Interval|Least Squares Mean
674808|NCT01644617|Secondary|Average Total Ocular Symptom Score (TOSS) During EEC Challenge Session at Week 24|The average total TOSS included the evaluation of 2 ocular symptoms: gritty/feeling/red/itchy eyes and watery eyes. The endpoint was based on participant diary entries over the last 4 hours of the EEC challenge session at Week 24. TOSS was the total of scores for the 2 ocular symptoms, each scored on a 4-point rating scale (0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms). The total TOSS ranged from 0 to 6 points. The Week 24 TOSS was analyzed using the ANCOVA model with treatment and baseline TOSS as covariates and expressed as a least squares mean with 95% confidence interval. A decrease in TOSS for participants receiving either dose of MK-8237 compared to placebo indicated an improvement in symptoms.|Week 24|Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint||Score on a Scale||95% Confidence Interval|Least Squares Mean
674809|NCT01644617|Secondary|Average TSS (TNSS + TOSS) During EEC Challenge Session at Week 8|The average total TSS included the evaluation of the 4 nasal symptoms of the TNSS (itchy nose, blocked nose, runny nose, and sneezing) plus the 2 ocular symptoms of the TOSS (gritty/feeling/red/itchy eyes and watery eyes). The endpoint was based on participant diary entries over the last 4 hours of the EEC challenge session at Week 8. TSS was the total of scores for the 4 nasal symptoms and 2 ocular symptoms, each scored on a 4-point rating scale (0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms). The total TSS ranged from 0 to 18 points. The Week 8 TSS was analyzed using the ANCOVA model with treatment and baseline TSS as covariates and expressed as a least squares mean with 95% confidence interval. A decrease in TSS for participants receiving either dose of MK-8237 compared to placebo indicated an improvement in symptoms.|Week 8|Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint||Score on a Scale||95% Confidence Interval|Least Squares Mean
674810|NCT01644617|Secondary|Average TSS (TNSS + TOSS) During EEC Challenge Session at Week 16|The average total TSS included the evaluation of the 4 nasal symptoms of the TNSS (itchy nose, blocked nose, runny nose, and sneezing) plus the 2 ocular symptoms of the TOSS (gritty/feeling/red/itchy eyes and watery eyes). The endpoint was based on participant diary entries over the last 4 hours of the EEC challenge session at Week 16. TSS was the total of scores for the 4 nasal symptoms and 2 ocular symptoms, each scored on a 4-point rating scale (0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms). The total TSS ranged from 0 to 18 points. The Week 16 TSS was analyzed using the ANCOVA model with treatment and baseline TSS as covariates and expressed as a least squares mean with 95% confidence interval. A decrease in TSS for participants receiving either dose of MK-8237 compared to placebo indicated an improvement in symptoms.|Week 16|Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint||Score on a Scale||95% Confidence Interval|Least Squares Mean
674811|NCT01644617|Secondary|Average Total Symptom Score (TSS [TNSS + TOSS]) During EEC Challenge Session at Week 24|The average total TSS included the evaluation of the 4 nasal symptoms of the TNSS (itchy nose, blocked nose, runny nose, and sneezing) plus the 2 ocular symptoms of the TOSS (gritty/feeling/red/itchy eyes and watery eyes). The endpoint was based on participant diary entries over the last 4 hours of the EEC challenge session at Week 24. TSS was the total of scores for the 4 nasal symptoms and 2 ocular symptoms, each scored on a 4-point rating scale (0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms). The total TSS ranged from 0 to 18 points. The Week 24 TSS was analyzed using the ANCOVA model with treatment and baseline TSS as covariates and expressed as a least squares mean with 95% confidence interval. A decrease in TSS for participants receiving either dose of MK-8237 compared to placebo indicated an improvement in symptoms.|Week 24|Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint||Score on a Scale||95% Confidence Interval|Least Squares Mean
675997|NCT01631825|Secondary|Each Item of UPDRS Part 1|The percentage of subjects with elevated scores for each item of UPDRS Part 1. The data at week 52 is shown.|Baseline, up to 54 weeks after dosing.|FAS, LOCF||Percentage of Participants|||Number
674812|NCT01644617|Secondary|Average TNSS During EEC Challenge Session at Week 8|The average total TNSS included the evaluation of 4 nasal symptoms: itchy nose, blocked nose, runny nose, and sneezing. The endpoint was based on participant diary entries over the last 4 hours of the EEC challenge session at Week 8. TNSS was the total of scores for the 4 nasal symptoms, each scored on a 4-point rating scale (0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms). The total TNSS ranged from 0 to 12 points. The Week 8 TNSS was analyzed using the ANCOVA model with treatment and baseline TNSS as covariates and expressed as a least squares mean with 95% confidence interval. A decrease in TNSS for participants receiving either dose of MK-8237 compared to placebo indicated an improvement in symptoms.|Week 8|Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint||Score on a Scale||95% Confidence Interval|Least Squares Mean
674813|NCT01644617|Secondary|Average TNSS During EEC Challenge Session at Week 16|The average total TNSS included the evaluation of 4 nasal symptoms: itchy nose, blocked nose, runny nose, and sneezing. The endpoint was based on participant diary entries over the last 4 hours of the EEC challenge session at Week 16. TNSS was the total of scores for the 4 nasal symptoms, each scored on a 4-point rating scale (0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms). The total TNSS ranged from 0 to 12 points. The Week 16 TNSS was analyzed using the ANCOVA model with treatment and baseline TNSS as covariates and expressed as a least squares mean with 95% confidence interval. A decrease in TNSS for participants receiving either dose of MK-8237 compared to placebo indicated an improvement in symptoms.|Week 16|Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint||Score on a Scale||95% Confidence Interval|Least Squares Mean
674814|NCT01644617|Primary|Average Total Nasal Symptom Score (TNSS) During Environmental Exposure Chamber (EEC) Challenge Session at Week 24|The average total TNSS included the evaluation of 4 nasal symptoms: itchy nose, blocked nose, runny nose, and sneezing. The endpoint was based on participant diary entries over the last 4 hours of the EEC challenge session at Week 24. TNSS was the total of scores for the 4 nasal symptoms, each scored on a 4-point rating scale (0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms). The total TNSS ranged from 0 to 12 points. The 24-week TNSS was analyzed using the analysis of covariance (ANCOVA) model with treatment and baseline TNSS as covariates and expressed as a least squares mean with 95% confidence interval. A decrease in TNSS for participants receiving either dose of MK-8237 compared to placebo indicated an improvement in symptoms.|Week 24|Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint||Score on a Scale||95% Confidence Interval|Least Squares Mean
674815|NCT01644500|Secondary|Visual Analog Scale (VAS) Score at Week 26|The EQ-5D questionnaire is a widely used, generic questionnaire that assesses health-related quality of life and consists of a 100-milliliter (mm) visual analog scale (VAS) on which the participant rated their perceived health state on that day from 0-mm (worst imaginable health state) to 100-mm (best imaginable health state).|Week 26|Participants who had been randomized, received at least one dose of study drug, had a baseline HbA1c measurement, had at least one post-baseline HbA1c measurement, and had evaluable VAS data.||units on a scale||Standard Deviation|Mean
674816|NCT01644500|Secondary|European Quality of Life Questionnaire-5 Dimensions (EQ-5D) Health State Score Responses at 26 Weeks|The EQ-5D questionnaire is a widely used, generic questionnaire that assesses 5 dimensions associated with quality of life (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension has 3 possible levels of response: no problem, some problem, and extreme problem. Additional categories of response include ambiguous and missing. The number of participants per each of the 5 response categories is summarized for each of the 5 dimensions.|Week 26|Participants who had been randomized, received at least one dose of study drug, had a baseline HbA1c measurement, had at least one post-baseline HbA1c measurement, and had evaluable EQ-5D data.||participants|||Number
674817|NCT01644500|Secondary|Number of Participants With Adjudicated Pancreatitis|The number of adjudicated (by an independent committee of expert physicians) pancreatic events is summarized at 26 weeks. A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 Weeks|All participants who were randomized and received at least 1 dose of study drug.||participants|||Number
674818|NCT01644500|Secondary|Number of Participants With Adjudicated Cardiovascular Events|Deaths and nonfatal cardiovascular adverse events (AEs) were adjudicated by a committee of physicians with cardiology expertise external to the Sponsor. The nonfatal cardiovascular AEs that were adjudicated included myocardial infarction; hospitalization for unstable angina; hospitalization for heart failure; coronary interventions (such as coronary artery bypass graft or percutaneous coronary intervention); and cerebrovascular events, including cerebrovascular accident (stroke) and transient ischemic attack. A summary of serious and other non-serious AEs regardless of causality, is located in the Reported Adverse Events module.|Baseline through 26 Weeks|All participants who were randomized and received at least 1 dose of study drug.||number of participants|||Number
674819|NCT01644500|Secondary|Proportion of Participants Developing Antibodies to Dulaglutide|Dulaglutide anti-drug antibodies (ADA) were assessed at baseline and 26 weeks. A participant was considered to have treatment-emergent dulaglutide ADA if the participant had at least 1 titer that was treatment-emergent relative to baseline, defined as a 4-fold or greater increase in titer from baseline measurement.|Baseline through 26 Weeks|All participants who were randomized, received at least 1 dose of study drug, and had evaluable ADA data.||percentage of participants|||Number
674820|NCT01644500|Secondary|Change From Baseline in Body Mass Index (BMI) at 26 Weeks|BMI is an estimate of body fat based on body weight divided by height squared. LS means were calculated using MMRM analysis adjusting for treatment, country, pre-study therapy stratum, visit, and treatment-by-visit as fixed effects; baseline body weight as covariate; and participant as a random effect.|Baseline, 26 Weeks|All participants who were randomized, received at least 1 dose of study drug, and had evaluable BMI data.||kilograms per meter squared (kg/m^2)||Standard Error|Least Squares Mean
674821|NCT01644500|Secondary|Change From Baseline in Body Weight at 26 Weeks|LS means were calculated using MMRM analysis adjusting for treatment, country, pre-study therapy stratum, visit, and treatment-by-visit as fixed effects; baseline body weight as covariate; and participant as a random effect.|Baseline, 26 Weeks|All participants who were randomized, received at least 1 dose of study drug, and had evaluable body weight data.||kilogram (kg)||Standard Error|Least Squares Mean
674823|NCT01644500|Secondary|Change From Baseline in Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval at 26 Weeks|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTcF = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. PR is the interval between the P wave and the QRS complex.|Baseline, 26 Weeks|All participants who were randomized, received at least 1 dose of study drug, and had evaluable ECG data.||milliseconds (msec)||Standard Deviation|Mean
674824|NCT01644500|Secondary|Change From Baseline in Sitting Pulse Rate at 26 Weeks|LS means were calculated using MMRM analysis adjusting for treatment, country, pre-study therapy stratum, visit, and treatment-by-visit as fixed effects; baseline pulse rate as covariate; and participant as a random effect.|Baseline, 26 Weeks|All participants who were randomized, received at least 1 dose of study drug, and had evaluable pulse rate data.||beats per minute (bpm)||Standard Error|Least Squares Mean
674825|NCT01644500|Secondary|Change From Baseline in Sitting Blood Pressure at 26 Weeks|Sitting systolic blood pressure (SBP) and sitting diastolic blood pressure (DBP) were measured. LS means were calculated using MMRM analysis adjusting for treatment, country, pre-study therapy stratum, visit, and treatment-by-visit as fixed effects; baseline blood pressure as covariate; and participant as a random effect.|Baseline, 26 Weeks|All participants who were randomized, received at least 1 dose of study drug, and had evaluable blood pressure data.||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
674826|NCT01644500|Secondary|Change From Baseline in Serum Calcitonin at 26 Weeks||Baseline, 26 Weeks|All participants who were randomized, received at least 1 dose of study drug, and had evaluable serum calcitonin data.||picomoles per liter (pmol/L)||Standard Deviation|Mean
674827|NCT01644500|Secondary|Change From Baseline in Pancreatic Enzymes at 26 Weeks|Amylase (total and pancreas-derived) and lipase concentrations were measured.|Baseline, 26 Weeks|All participants who were randomized, received at least 1 dose of study drug, and had evaluable pancreatic enzyme data.||units per liter (u/L)||Standard Deviation|Mean
674828|NCT01644500|Secondary|Incidence of All Hypoglycemic Episodes|The overall number of participants with self-reported hypoglycemic episodes is presented.|Baseline through 26 Weeks|All participants who were randomized and received at least 1 dose of study drug.||participants|||Number
674829|NCT01644500|Secondary|Change From Baseline in Homeostasis Model Assessment 2 Insulin Sensitivity - Cell Function (HOMA2-%S) at 26 Weeks|Change from baseline in HOMA2-%S was assessed by using the HOMA to quantify insulin sensitivity. HOMA2-%S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state insulin sensitivity (%S) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. LS means were calculated using an ANCOVA model with country, baseline, pre-treatment, and treatment as fixed effects.|Baseline, up to 26 Weeks|Participants who had been randomized, received at least one dose of study drug, had a baseline HbA1c measurement, and had at least one post-baseline HbA1c measurement. LOCF methodology was used to impute missing post-baseline values.||percentage of HOMA2-%S||Standard Error|Least Squares Mean
674830|NCT01644500|Secondary|Change From Baseline in Homeostasis Model Assessment 2 Steady-state Beta (β) - Cell Function (HOMA2-%B) at 26 Weeks|Change from baseline in HOMA2-%B was assessed by using the homeostasis model assessment (HOMA) to quantify β-cell function. HOMA2-%B is a computer model that uses FBG, insulin, and C-peptide concentrations to estimate steady state β-cell function (%B) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. LS means were calculated using an analysis of covariance (ANCOVA) model with country, baseline, pre-treatment, and treatment as fixed effects.|Baseline, up to 26 Weeks|Participants who had been randomized, received at least one dose of study drug, had a baseline HbA1c measurement, and had at least one post-baseline HbA1c measurement. LOCF methodology was used to impute missing post-baseline values.||percentage of HOMA2-%B||Standard Error|Least Squares Mean
674831|NCT01644500|Secondary|Rate of Hypoglycemic Episodes|Hypoglycemic episodes are defined as events that are associated with reported signs and symptoms of hypoglycemia and/or documented BG concentrations of ≤70 milligrams per deciliter (mg/dL) (≤3.9 mmol/L). A severe hypoglycemic episode was defined as any hypoglycemic event for which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Nocturnal hypoglycemia is defined as any hypoglycemic event that occurs between bedtime and waking. Log mean rates of total hypoglycemia (per 30 days per participant) are presented and were calculated from negative binomial regression model. The model included country/region, prior medication group, treatment, visit, and treatment-by-visit interaction. The logarithm of days between visits was adjusted as an offset to account for possible unequal duration between visits and between participants.|Baseline through 26 Weeks|Participants who had been randomized, received at least one dose of study drug, and had evaluable hypoglycemic data.||episodes/participant/30 days||Standard Error|Log Mean
674832|NCT01644500|Secondary|Change From Baseline in 7-point Self-monitored Blood Glucose (SMBG) Profiles at 26 Weeks|Change from baseline in mean daily blood glucose (BG) values were measured with a 7-point SMBG profile. Participants recorded their 7-point SMBG profiles on 2 separate, non-consecutive days during the 2-week period immediately before randomization, Week 8, Week 16, and Week 26 (or the Early Discontinuation Visit). The 7-point SMBG profile consisted of pre-prandial BG measures before the morning (fasting), midday, and evening meals; BG measures 2 hours after the start (post-prandial) of the morning, midday, and evening meals; and BG measures at bedtime. Mean at 26 weeks was assessed in all treatment groups. LS means were calculated using MMRM analysis adjusting for treatment, country, pre-study therapy stratum, visit, and treatment-by-visit as fixed effects; baseline body weight as covariate; and participant as a random effect.|Baseline, 26 Weeks|Participants who had been randomized, received at least one dose of study drug, had a baseline HbA1c measurement, and had at least one post-baseline HbA1c measurement.||mmol/L||Standard Error|Least Squares Mean
674833|NCT01644500|Secondary|Change From Baseline in Fasting Blood Glucose (FBG) at 26 Weeks|FBG is a test to determine how much glucose (sugar) is in a blood sample after an overnight fast. FBG was measured by a central laboratory. LS means were calculated using MMRM analysis adjusting for treatment, country, pre-study therapy stratum, visit, and treatment-by-visit as fixed effects; baseline FBG as covariate; and participant as a random effect.|Baseline, 26 Weeks|Participants who had been randomized, received at least one dose of study drug, had a baseline HbA1c measurement, and had at least one post-baseline HbA1c measurement.||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
674834|NCT01644500|Secondary|Percentage of Participants Attaining HbA1c of <7% or ≤6.5% at 26 Weeks|Percentages of participants who achieved HbA1c levels of <7% or ≤6.5% were analyzed using a logistic regression model, controlling for treatment, pre-treatment, baseline HbA1c and country.|26 Weeks|Participants who had been randomized, received at least one dose of study drug, had a baseline HbA1c measurement, and had at least one post-baseline HbA1c measurement. Last observation carried forward (LOCF) methodology was used to impute missing post-baseline values.||percentage of participants|||Number
674835|NCT01644500|Primary|Change From Baseline in HbA1c at 26 Weeks|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) analysis adjusting for treatment, country, pre-study therapy stratum, visit, and treatment-by-visit as fixed effects; baseline HbA1c as covariate; and participant as a random effect.|Baseline, 26 Weeks|Participants who had been randomized, received at least one dose of study drug, had a baseline HbA1c measurement, and had at least one post-baseline HbA1c measurement.||percentage of HbA1c||Standard Error|Least Squares Mean
674836|NCT01644474|Secondary|Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|From Baseline to Week 24|Apo A-1 ITT population.||percent change||Standard Error|Mean
674837|NCT01644474|Secondary|Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline Apo A-1 value on­ or off-treatment (Apo A-1 ITT population).||percent change||Standard Error|Least Squares Mean
674838|NCT01644474|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|From Baseline to Week 24|ITT population.||percent change||Standard Error|Mean
674839|NCT01644474|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|From Baseline to Week 24|ITT population.||percent change||Standard Error|Mean
674840|NCT01644474|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|From Baseline to Week 24|ITT population.||percent change||Standard Error|Mean
674841|NCT01644474|Secondary|Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|From Baseline to Week 24|HDL-C ITT population.||percent change||Standard Error|Least Squares Mean
674842|NCT01644474|Secondary|Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline HDL-C value on­ or off-treatment (HDL-C ITT population).||percent change||Standard Error|Least Squares Mean
674843|NCT01644474|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from a multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|From Baseline to Week 24|ITT population.||percent change||Standard Error|Mean
674844|NCT01644474|Secondary|Percentage of Participants Achieving Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis|Adjusted percentages at Week 24 from multiple imputation approach model including all available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|Up to Week 24|ITT population.||percentage of participants|||Number
674845|NCT01644474|Secondary|Percentage of Participants Achieving Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - ITT Analysis|Adjusted percentages at Week 24 were obtained from multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment were included in the imputation model.|Up to Week 24|ITT population.||percentage of participants|||Number
674846|NCT01644474|Secondary|Percent Change From Baseline in Total-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|From Baseline to Week 24|Total-C ITT population.||percent change||Standard Error|Least Squares Mean
674847|NCT01644474|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|From Baseline to Week 24|non-HDL-C ITT population.||percent change||Standard Error|Least Squares Mean
674848|NCT01644474|Secondary|Percent Change From Baseline in Apo B at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|From Baseline to Week 24|Apo-B ITT population.||percent change||Standard Error|Least Squares Mean
674849|NCT01644474|Secondary|Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline Total-C value on­ or off-treatment (Total-C ITT population).||percent change||Standard Error|Least Squares Mean
674867|NCT01644396|Other Pre-specified|Change From Baseline in Glucose|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.||mmol/L||Standard Deviation|Mean
674850|NCT01644474|Secondary|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline non-HDL-C value on­ or off-treatment (non-HDL-C ITT population).||percent change||Standard Error|Least Squares Mean
674851|NCT01644474|Secondary|Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline Apo B value on­ or off-treatment (Apo B ITT population).||percent change||Standard Error|Least Squares Mean
674852|NCT01644474|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|From Baseline to Week 24|ITT population.||percent change||Standard Error|Least Squares Mean
674853|NCT01644474|Primary|Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis|Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment were used in the model (ITT analysis).|From Baseline to Week 24|ITT population: all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on­ or off-treatment.||percent change||Standard Error|Least Squares Mean
674854|NCT01644396|Other Pre-specified|Number of Participants With Adverse Events (AEs)|"An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment.
The investigator rated the severity of each AE as either:
Mild: The AE is transient and easily tolerated; Moderate: The AE causes the participant discomfort and interrupts usual activities.
Severe: The AE causes considerable interference with usual activities and may be incapacitating or life-threatening.
A serious adverse event (SAE) is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome.
Drug-related AEs are those assessed by the investigator as either probably or possibly related.
Other malignancy excludes lymphoma, hepatosplenic T-cell lymphoma (HSTCL), leukemia, non-melanoma skin cancer (NMSC), and melanoma."|From the first dose of study drug until 70 days after the last dose (up to 33 weeks).|||participants|||Number
674855|NCT01644396|Other Pre-specified|Change From Baseline in Body Temperature|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.||degrees celsius||Standard Deviation|Mean
674856|NCT01644396|Other Pre-specified|Change From Baseline in Weight|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.||kg||Standard Deviation|Mean
674857|NCT01644396|Other Pre-specified|Change From Baseline in Respiratory Rate|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.||respirations per minute||Standard Deviation|Mean
674858|NCT01644396|Other Pre-specified|Change From Baseline in Pulse|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.||beats per minute||Standard Deviation|Mean
674859|NCT01644396|Other Pre-specified|Change From Baseline in Blood Pressure|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|||mm Hg||Standard Deviation|Mean
674860|NCT01644396|Other Pre-specified|Change From Baseline in Urine Specific Gravity|Safety variables included laboratory data, vital signs and adverse events. Specific gravity is a measure of the amount of material dissolved in the urine. Specific gravity is the ratio of the density (mass of a unit volume) of a substance to the density (mass of the same unit volume) of a reference substance.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.||ratio||Standard Deviation|Mean
674861|NCT01644396|Other Pre-specified|Change From Baseline in Urine pH|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.||pH units||Standard Deviation|Mean
674862|NCT01644396|Other Pre-specified|Change From Baseline in High Sensitivity C-reactive Protein (hsCRP)|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.||mg/L||Standard Deviation|Mean
674863|NCT01644396|Other Pre-specified|Change From Baseline in Triglycerides|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.||mmol/L||Standard Deviation|Mean
674864|NCT01644396|Other Pre-specified|Change From Baseline in Cholesterol|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.||mmol/L||Standard Deviation|Mean
674865|NCT01644396|Other Pre-specified|Change From Baseline in Total Protein|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.||g/L||Standard Deviation|Mean
674870|NCT01644396|Other Pre-specified|Change From Baseline in Uric Acid|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.||µmol/L||Standard Deviation|Mean
674871|NCT01644396|Other Pre-specified|Change From Baseline in Blood Urea Nitrogen (BUN)|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.||mmol/L||Standard Deviation|Mean
674872|NCT01644396|Other Pre-specified|Change From Baseline in Creatinine|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.||µmol/L||Standard Deviation|Mean
674873|NCT01644396|Other Pre-specified|Change From Baseline in Total Bilirubin|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.||µmol/L||Standard Deviation|Mean
674874|NCT01644396|Other Pre-specified|Change From Baseline in Alkaline Phosphatase|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.||U/L||Standard Deviation|Mean
674875|NCT01644396|Other Pre-specified|Change From Baseline in Aspartate Aminotransferase|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.||U/L||Standard Deviation|Mean
674876|NCT01644396|Other Pre-specified|Change From Baseline in Alanine Aminotransferase|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.||U/L||Standard Deviation|Mean
674877|NCT01644396|Other Pre-specified|Change From Baseline in Erythrocyte Sedimentation Rate|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.||mm/hour||Standard Deviation|Mean
674878|NCT01644396|Other Pre-specified|Change From Baseline in Blood Cell Counts|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.||× 10^9 cells/L||Standard Deviation|Mean
674879|NCT01644396|Secondary|Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI)|"NAPSI grades nails for both nail matrix psoriasis and nail bed psoriasis. The most affected fingernail was determined at Baseline and used for the analysis.
Nail matrix psoriasis consists of any of the following: pitting, leukonychia, red spots in the lunula, or nail plate crumbling. Nail bed psoriasis is the presence or absence of onycholysis, splinter hemorrhages, oil drop (salman patch) discoloration or nail bed hyperkeratosis. Scoring for each is based on the following scale:
0 = none;
1 = present in 1/4 nail quadrants;
2 = present in 2/4 nail quadrants;
3 = present in 3/4 nail quadrants;
4 = present in 4/4 nail quadrants.
The sum of these two scores is the total score for the nail, and ranges from 0 (no nail psoriasis) to 8 (psoriasis in 4/4 nail quadrants). Change from Baseline is presented as a percentage of the Baseline value, calculated as: Week 24 value - Baseline value / Baseline value * 100. A negative change from Baseline indicates improvement."|Baseline and Week 24|Intent-to-treat population who had a NAPSI score ≥ 0 at the Baseline visit; last observation carried forward (LOCF) imputation was used.||percent change||Standard Deviation|Mean
674880|NCT01644396|Secondary|Percent Change From Baseline in Dermatology Life Quality Index (DLQI)|The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. Change from Baseline is presented as a percentage of the Baseline value: Post-baseline value - Baseline value / Baseline value * 100. A negative change from Baseline indicates improvement.|Baseline and Weeks 8, 12, and 24|Intent-to-treat population with available data; last observation carried forward (LOCF) imputation was used.||percent change||Standard Deviation|Mean
674881|NCT01644396|Secondary|Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score|"PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.
Change from Baseline is presented as a percentage of the Baseline value: Post-baseline value - Baseline value / Baseline value * 100. A negative change from Baseline indicates improvement."|Baseline and Weeks 2, 4, 8, 12, 16, and 24|Intent-to-treat population; last observation carried forward (LOCF) imputation was used.||percent change||Standard Deviation|Mean
674882|NCT01644396|Secondary|Percentage of Participants Achieving a PASI 100 Response|The percentage of participants with a 100% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.|Baseline and Weeks 2, 4, 8, 12, 16, and 24|Intent-to-treat population; non-responder analysis was used.||percentage of participants|||Number
674883|NCT01644396|Secondary|Percentage of Participants Achieving a PASI 90 Response|The percentage of participants with a ≥ 90% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.|Baseline and Weeks 2, 4, 8, 12, 16, and 24|Intent-to-treat population; non-responder imputation was used.||percentage of participants|||Number
674884|NCT01644396|Secondary|Percentage of Participants Achieving a PASI 75 Response|The percentage of participants with a ≥ 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.|Baseline and Weeks 2, 4, 8, 12, and 16|Intent-to-treat population; non-responder imputation was used.||percentage of participants|||Number
674885|NCT01644396|Secondary|Percentage of Participants Achieving a PASI 50 Response|The percentage of participants with a ≥ 50% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.|Baseline and Weeks 2, 4, 8, 12, 16, and 24|Intent-to-treat population; non-responder imputation was used.||percentage of participants|||Number
674886|NCT01644396|Secondary|Percentage of Participants Achieving a One Grade Improvement in Physician’s Global Assessment (PGA)|"The PGA is a 6-point scale used to measure the severity of disease at the time of the qualified investigator's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories:
0: No evidence of scaling, erythema, or plaque elevation, overall score of cleared;
1: Occasional fine scale over <5% of lesions, faint erythema, minimal plaque elevation, overall score of minimal;
2: Fine scale dominates, light red coloration, mild plaque elevation, overall score of mild;
3: Course scale dominates, moderate red coloration, moderate plaque elevation, overall score of moderate;
4: Thick non-tenacious scale dominates, bright red coloration, marked plaque elevation, overall score of marked;
5: Very thick tenacious scale predominates, dusky to deep red coloration, severe plaque elevation, overall score of severe.
The percentage of participants achieving a shift from Baseline to a less severe category is reported."|Baseline and Weeks 2, 4, 8, 12, 16 and 24|Intent-to-treat population; non-responder imputation was used.||percentage of participants|||Number
674887|NCT01644396|Secondary|Percentage of Participants Achieving a Physician’s Global Assessment of Clear or Minimal|"The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the qualified investigator's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories:
0: No evidence of scaling, erythema, or plaque elevation, overall score of cleared;
1: Occasional fine scale over <5% of lesions, faint erythema, minimal plaque elevation, overall score of minimal;
2: Fine scale dominates, light red coloration, mild plaque elevation, overall score of mild;
3: Course scale dominates, moderate red coloration, moderate plaque elevation, overall score of moderate;
4: Thick non-tenacious scale dominates, bright red coloration, marked plaque elevation, overall score of marked;
5: Very thick tenacious scale predominates, dusky to deep red coloration, severe plaque elevation, overall score of severe.
The percentage of participants achieving a PGA score of clear (0) or minimal (1) is reported."|Weeks 2, 4, 8, 12, 16 and 24|Intent-to-treat population; non-responder imputation was used.||percentage of participants|||Number
674888|NCT01644396|Secondary|Percentage of Participants Achieving a Physician’s Global Assessment of Clear|"The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the qualified investigator's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories:
0: No evidence of scaling, erythema, or plaque elevation, overall score of cleared;
1: Occasional fine scale over <5% of lesions, faint erythema, minimal plaque elevation, overall score of minimal;
2: Fine scale dominates, light red coloration, mild plaque elevation, overall score of mild;
3: Course scale dominates, moderate red coloration, moderate plaque elevation, overall score of moderate;
4: Thick non-tenacious scale dominates, bright red coloration, marked plaque elevation, overall score of marked;
5: Very thick tenacious scale predominates, dusky to deep red coloration, severe plaque elevation, overall score of severe.
The percentage of participants achieving a PGA score of clear (0) is reported."|Weeks 2, 4, 8, 12, 16 and 24|Intent-to-treat population; non-responder imputation was used.||percentage of participants|||Number
674889|NCT01644396|Other Pre-specified|Change From Baseline in Red Blood Cell Count|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.||× 10^12 cells/L||Standard Deviation|Mean
674890|NCT01644396|Other Pre-specified|Change From Baseline in Hematocrit|Safety variables included laboratory data, vital signs and adverse events. The hematocrit measures the volume of red blood cells compared to the total blood volume (red blood cells and plasma).|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.||liters/liter||Standard Deviation|Mean
674891|NCT01644396|Other Pre-specified|Change From Baseline in Hemoglobin|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.||g/L||Standard Deviation|Mean
676179|NCT01628926|Secondary|Effective Rate in UPDRS Part 3 Sum Score|Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in UPDRS Part 3 sum score (on state) at 16 weeks after dosing.|Baseline, 16 weeks after dosing|FAS, LOCF||Percentage of participants||95% Confidence Interval|Number
674892|NCT01644396|Primary|Percentage of Participants Achieving a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 24|The percentage of participants with a ≥ 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.|Baseline and Week 24|Intent-to-treat population; non-responder imputation (NRI) was used, where participants with a missing value were counted as a non-responders.||percentage of participants|||Number
674893|NCT01644331|Secondary|All Cause Death or Rehospitalization|All cause death or rehospitalization (to include unscheduled clinic visits or ED visits) at 30 days (Kaplan-Meier and 95% confidence interval)|30 days|baseline population||proportion of participants||95% Confidence Interval|Mean
674894|NCT01644331|Secondary|Days Hospitalized or Deceased|Total days hospitalized or deceased during the 30 days after randomization|30 days|baseline population||days||Standard Deviation|Mean
674895|NCT01644331|Secondary|Development of Worsening Renal Function|increase in serum creatinine ≥ 0.3mg/dl from randomization at any time point during 72 hours after randomization|72 hours|baseline population||Participants|||Count of Participants
674896|NCT01644331|Secondary|Freedom From Congestion|Jugular Venous Pressure (JVP) < 8 cm, no orthopnea, trace peripheral edema or less, and will be assessed at 24, 48, and 72 hours|24, 48, and 72 hours|baseline population||Participants|||Count of Participants
674897|NCT01644331|Secondary|Dyspnea 11 Point NRS|Change in NRS for assessment of dyspnea from baseline to 24, 48, and 72 hours (scale ranges from 0-No difficulty breathing to 10-Difficulty as bad as you can imagine)|0, 24, 48, and 72 hours|baseline population||units on a scale||Standard Deviation|Mean
674898|NCT01644331|Secondary|Serum Sodium|Change in serum sodium from baseline to 24, 48, and 72 hours|0, 24, 48, and 72 hours|baseline population||mmol/L||Standard Deviation|Mean
674899|NCT01644331|Secondary|Over-diuresis|clinical evidence of volume depletion requiring intervention other than holding diuretics during the 72 hours after randomization|72 hours|baseline population||Participants|||Count of Participants
674900|NCT01644331|Secondary|Worsening or Persistent Heart Failure or Death|Number of patients with worsening heart failure or death|72 hrs|baseline population||Participants|||Count of Participants
674901|NCT01644331|Secondary|Hospital Stay|Total days spent in hospital from baseline until discharge or death|7 days|baseline population||days||Standard Deviation|Mean
674902|NCT01644331|Secondary|Dyspnea Likert|Number of patients that experience moderate or greater improvement (patient reported) in dyspnea by 7 point Likert scale at 48 and 72 hours|48 and 72 hours|baseline population||Participants|||Count of Participants
674903|NCT01644331|Secondary|Fluid Loss|Change from baseline fluid balance at 24, 48, and 72 hours|0, 24, 48, and 72 hours|baseline population||mL||Standard Deviation|Mean
674904|NCT01644331|Secondary|Weight Loss|Change in body weight from baseline to 24, 48, and 72 hours|0, 24, 48, and 72 hours|Baseline population||lbs||Standard Deviation|Mean
674905|NCT01644331|Secondary|Renal Function|Change in Serum creatinine from baseline to 24, 48 and 72 hours|0, 24, 48 and 72 hours|Baseline population||mg/dL||Standard Deviation|Mean
674906|NCT01644331|Primary|Dyspnea Improvement Measured by Likert Scale at 8 and 24 Hours|The number of patients with at least moderate improvement (as reported by patient) in dyspnea Likert scale at both 8 AND 24 hours AND without the need for escalation of therapy due to worsening heart failure (rescue therapy) or death within 24 hours.|8 and 24 hours|Baseline population||Participants|||Count of Participants
674907|NCT01644292|Primary|Change From Baseline in Wheelchair Skills Test (WST) 4.1 Capacity Score|The WST is a structured assessment with 32 discrete mobility skills required to perform social roles in the community, each scored dichotomously as pass/fail. The WST produces a total Skill Capacity score (0-100%) reflecting the number of skills safely passed.|Baseline and follow-up (1 month)|||units on a scale||Standard Deviation|Mean
674908|NCT01644240|Primary|CLss|Apparent clearance|Day 5|||L/hr||Standard Deviation|Mean
674909|NCT01644240|Primary|Vss|Apparent volume of distribution at steady state|Day 5|||L||Standard Deviation|Mean
674910|NCT01644240|Primary|AUCtau|Area under the plasma concentration time curve over the dosing interval estimated using the linear trapezoidal rule.|Day 5|||pg*hr/mL||Standard Deviation|Mean
674911|NCT01644240|Primary|AUC0-∞|Area under the plasma concentration time curve from 0 to infinity.|Day 5|||pg*hr/mL||Standard Deviation|Mean
674912|NCT01644240|Primary|AUC0-24|Area under the plasma concentration time curve 24 hours following the last dose.|Day 5|||pg*hr/mL||Standard Deviation|Mean
674913|NCT01644240|Primary|t½|Time to 50% plasma concentration|Day 5|||hours||Standard Deviation|Mean
674914|NCT01644240|Primary|Tmax|Time to reach maximum plasma concentration.|Day 5|||hours||Full Range|Median
674915|NCT01644240|Secondary|Number of Subjects With Adverse Events||1 week|||participants|||Number
674916|NCT01644240|Primary|Cmax|Maximum plasma concentration|Day 5|||pg/mL||Standard Deviation|Mean
674917|NCT01644240|Primary|Plasma CL|Plasma clearance|Day 1|||L/hr||Standard Deviation|Mean
674918|NCT01644240|Primary|Plasma Vz|Volume of distribution|Day 1|||Liters||Standard Deviation|Mean
674919|NCT01644240|Primary|AUCtau|Area under the plasma concentration time curve over the dosing interval estimated using the linear trapezoidal rule.|Day 1|||pg*hr/mL||Standard Deviation|Mean
674920|NCT01644240|Primary|AUC0-∞|Area under the concentration time curve from time 0 to infinity.|Day 1|||pg*hr/mL||Standard Deviation|Mean
674921|NCT01644240|Primary|AUC0-24|Area under the plasma concentration time curve through 24 hours after dosing.|Day 1|||pg*hr/mL||Standard Deviation|Mean
674922|NCT01644240|Primary|t½|Time to 50% plasma concentration|Day 1|Subjects did not meet extrapolation criteria and were not included in the analysis.||hours||Standard Deviation|Mean
674923|NCT01644240|Primary|Tmax|Time to maximum plasma concentration|Day 1|||hours||Full Range|Median
674924|NCT01644240|Primary|Cmax|Maximum concentration in plasma following dosing on Day 1|Day 1|Sample size was 6 at all time points with the exception of 0.5 hours for dose 2 where value was considered an outlier and one subject was excluded from the PK analysis resulting in sample size of 5.||pg/mL||Standard Deviation|Mean
674925|NCT01644188|Other Pre-specified|Percent Change From Baseline in Calculated LDL-C at Week 104 – On-Treatment Analysis|Adjusted LS means and standard errors at Week 104 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 104 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first).|From Baseline to Week 104|mITT population.||Percent change||Standard Error|Least Squares Mean
674926|NCT01644188|Other Pre-specified|Percent Change From Baseline in Calculated LDL-C at Week 104 - ITT Analysis|Adjusted LS means and standard errors at Week 104 from MMRM including all available post-baseline data from Week 4 to Week 104 regardless of status on-or off-treatment.|From Baseline to Week 104|ITT population.||Percent change||Standard Error|Least Squares Mean
674927|NCT01644188|Other Pre-specified|Percent Change From Baseline in Calculated LDL-C at Week 52 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 52 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first).|From Baseline to Week 52|mITT population.||Percent change||Standard Error|Least Squares Mean
674928|NCT01644188|Secondary|Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Apo A-1 ITT population.||percent change||Standard Error|Least Squares Mean
674929|NCT01644188|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.||percent change||Standard Error|Mean
674930|NCT01644188|Secondary|Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|HDL-C ITT population.||percent change||Standard Error|Least Squares Mean
674931|NCT01644188|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.||percent change||Standard Error|Mean
674932|NCT01644188|Secondary|Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline Apo A-1 value on- or off-treatment (Apo A-1 ITT population).||percent change||Standard Error|Least Squares Mean
674933|NCT01644188|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.||percent change||Standard Error|Mean
674934|NCT01644188|Secondary|Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline HDL-C value on- or off-treatment (HDL-C ITT population).||percent change||Standard Error|Least Squares Mean
674935|NCT01644188|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 were obtained from multiple imputation approach followed by robust regression model for handling of missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were included in the imputation model.|From baseline to Week 52|ITT population.||percent change||Standard Error|Mean
674936|NCT01644188|Secondary|Percentage of Participants Achieving Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis|Adjusted percentages at Week 24 from multiple imputation approach including available post-baseline on-treatment data from week 4 to week 52 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first).|Up to Week 52|mITT population.||percentage of participants|||Number
674937|NCT01644188|Secondary|Percentage of Participants Achieving Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis|Adjusted percentages at Week 24 were obtained from multiple imputation approach for handling of missing data. All available post-baseline data from week 4 to week 52 regardless of status on- or off-treatment were included in the imputation model.|Up to Week 52|ITT population.||percentage of participants|||Number
674938|NCT01644188|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 52 - ITT Analysis|Adjusted LS means and standard errors at Week 52 from a MMRM model including all available post-baseline data from week 4 to week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.||percent change||Standard Error|Least Squares Mean
674939|NCT01644188|Secondary|Percent Change From Baseline in Total-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Total-C ITT population||percent change||Standard Error|Least Squares Mean
674940|NCT01644188|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Non-HDL-C ITT population.||percent change||Standard Error|Least Squares Mean
674941|NCT01644188|Secondary|Percent Change From Baseline in Apo-B at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Apo-B ITT population.||percent change||Standard Error|Least Squares Mean
675183|NCT01642082|Secondary|Duration of Survival|Duration of survival is defined as the duration alive from study entry until death or last contact.|Patients are followed every three months for the first two years and then every six months for the next three years.|All eligible and treated patients||months||90% Confidence Interval|Median
674942|NCT01644188|Secondary|Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline Total-C value on- or off-treatment (Total-C ITT population).||percent change||Standard Error|Least Squares Mean
674943|NCT01644188|Secondary|Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first).|From Baseline up to Week 52|Participants of the mITT population with one baseline and at least one post-baseline non-HDL-C value on-treatment (non-HDL-C mITT population).||percent change||Standard Error|Least Squares Mean
674944|NCT01644188|Secondary|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment (non-HDL-C ITT population).||percent change||Standard Error|Least Squares Mean
674945|NCT01644188|Secondary|Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first).|From Baseline to Week 52|Participants of the mITT population with one baseline and at least one post-baseline Apo B value on-treatment (Apo-B mITT population).||percent change||Standard Error|Least Squares Mean
674946|NCT01644188|Secondary|Percent Change From Baseline in Apolipoprotein B (Apo-B) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline Apo-B value on-or off-treatment (Apo-B ITT population).||percent change||Standard Error|Least Squares Mean
674947|NCT01644188|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first).|From Baseline to Week 52|mITT population.||percent change||Standard Error|Least Squares Mean
674948|NCT01644188|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from a MMRM including all available post-baseline data from week 4 to week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.||percent change||Standard Error|Least Squares Mean
674949|NCT01644188|Secondary|Percent Change From Baseline in Calculated LDL­-C at Week 24 - On­-Treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first).|From Baseline to Week 52|Modified ITT population (mITT): all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.||percent change||Standard Error|Least Squares Mean
674950|NCT01644188|Primary|Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis|Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from week 4 to week 52 regardless of status on- or off-treatment were used in the model (ITT analysis).|From Baseline to Week 52|ITT population: all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment.||percent change||Standard Error|Least Squares Mean
674951|NCT01644175|Secondary|Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Apo A-1 ITT population.||percent change||Standard Error|Least Squares Mean
674952|NCT01644175|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from multiple imputation approach followed by a robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.||percent change||Standard Error|Mean
674953|NCT01644175|Secondary|Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|HDL-C ITT population.||percent change||Standard Error|Least Squares Mean
674954|NCT01644175|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 12- ITT Analysis|Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.||percent change||Standard Error|Mean
674955|NCT01644175|Secondary|Percent Change From Baseline in Apolipoprotein A-1 at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline Apo A-1 value on- or off-treatment (Apo A-1 ITT population).||percent change||Standard Error|Least Squares Mean
674956|NCT01644175|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from multiple imputation approach followed be robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.||percent change||Standard Error|Mean
675408|NCT01639742|Secondary|Subject Satisfaction With Breasts Using the BREAST-Q Questionnaire|Participants evaluated satisfaction with their breasts using the BREAST-Q. Summary scores were computed by summing the score of each response and transferring them to a 0 (worst) to 100 (best) scale.|6 months|Full analysis population included all participants.||score on a scale||Standard Deviation|Mean
674957|NCT01644175|Secondary|Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline HDL-C value on- or off-treatment (HDL-C ITT population).||percent change||Standard Error|Least Squares Mean
674958|NCT01644175|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 were obtained from multiple imputation approach followed by robust regression model for handling of missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were included in the imputation model.|From baseline to Week 52|ITT population.||percent change||Standard Error|Mean
674959|NCT01644175|Secondary|Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-treatment Analysis|Adjusted percentages at Week 24 from multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 52 i.e. up to 21 days after last injection.|Up to Week 52|mITT population.||percentage of participants|||Number
674960|NCT01644175|Secondary|Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis|Adjusted percentages at Week 24 were obtained from multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were included in the imputation model.|Up to Week 52|ITT population.||percentage of participants|||Number
674961|NCT01644175|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 52 - ITT Analysis|Adjusted LS means and standard errors at Week 52 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.||percent change||Standard Error|Least Squares Mean
674962|NCT01644175|Secondary|Percent Change From Baseline in Total-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Total-C ITT population.||percent change||Standard Error|Least Squares Mean
674963|NCT01644175|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Non-HDL-C ITT population.||percent change||Standard Error|Least Squares Mean
674964|NCT01644175|Secondary|Percent Change From Baseline in Apo B at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Apo B ITT population.||percent change||Standard Error|Least Squares Mean
674965|NCT01644175|Secondary|Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline Total-C value on- or off-treatment (Total-C ITT population).||percent change||Standard Error|Least Squares Mean
674966|NCT01644175|Secondary|Percent Change From Baseline in Non-HDL-C at Week 24 - On-treatment Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|From Baseline to Week 52|Participants of the mITT population with one baseline and at least one post-baseline non-HDL-C value on-treatment (non-HDL-C mITT population).||percent change||Standard Error|Least Squares Mean
674967|NCT01644175|Secondary|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment (non-HDL-C ITT population).||percent change||Standard Error|Least Squares Mean
674968|NCT01644175|Secondary|Percent Change From Baseline in Apo B at Week 24 - On-treatment Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|From Baseline to Week 52|Participants of the mITT population with one baseline and at least one post-baseline Apo B value on-treatment (Apo B mITT population).||percent change||Standard Error|Least Squares Mean
674969|NCT01644175|Secondary|Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline Apo B value on- or off-treatment (Apo B ITT population).||percent change||Standard Error|Least Squares Mean
674970|NCT01644175|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|From Baseline to Week 52|mITT population.||percent change||Standard Error|Least Squares Mean
674971|NCT01644175|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.||percent change||Standard Error|Least Squares Mean
674972|NCT01644175|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection) (on-treatment analysis).|From Baseline to Week 52|Modified ITT (mITT) population: all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.||percent change||Standard Error|Least Squares Mean
675409|NCT01639742|Primary|Investigator Overall Satisfaction With the Device Using a 5-Point Scale|The investigator evaluated the overall satisfaction with the device using a 5-point scale where 1=definitely dissatisfied with the device to 5=definitely satisfied with the device.|3 months|Full analysis population included all participants.||score on a scale||Standard Deviation|Mean
674973|NCT01644175|Primary|Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis|Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were used in the model (ITT analysis).|From Baseline to Week 52|ITT population: all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment.||percent change||Standard Error|Least Squares Mean
674974|NCT01644058|Primary|Oral-health-related Quality of Life With the Immediate Loading Protocol|Oral Health Impact Profile (OHIP-20) to assess oral-health-related quality of life: score ranges between 20 and 120 points, with a lower score indicating a better oral-health-related quality of life.|4 months|||units on a scale||Standard Deviation|Mean
674975|NCT01644058|Primary|Patient Satisfaction With the Immediate Loading Protocol|Visual Analogue Scale (VAS) to assess patients' satisfaction, with a score of 100 being extremely satisfied (minimum and maximum scores: 1-100 respectively).|4 months|||millimeters||Standard Deviation|Mean
674976|NCT01643928|Primary|Outcome Measure Using HAQ-DI - by the End of Course 3|"HAQ-DI assessed the degree of difficulty participants experienced in 8 daily living activity domains during a week: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consisted of 2-3 items. Each question’s difficulty was scored from 0-3 (0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do). Activities requiring assistance (from people or assistive devices) were adjusted to ≥2 to denote more limited functional status. The questionnaire was to be completed by the participant prior to any procedures during the visit, if possible.
Overall HAQ-DI score was computed as the sum of domain scores divided by the number of domains answered, providing a score from 0-3. Low scores denoted improvement of disability/lower degree of domain difficulty.
Primary outcome reported in the table is mean HAQ-DI score at each time point, and it is on the scale of HAQ-DI score with the range from 0 to 3."|Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).|mITT Population - The mITT population for Course 3 was defined as all participants who received the treatments of all 3 courses of study B3281004.||Score on a scale||Standard Deviation|Mean
674977|NCT01643928|Primary|Outcome Measure Using HAQ-DI - by the End of Course 2|"HAQ-DI assessed the degree of difficulty participants experienced in 8 daily living activity domains during a week: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consisted of 2-3 items. Each question’s difficulty was scored from 0-3 (0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do). Activities requiring assistance (from people or assistive devices) were adjusted to ≥2 to denote more limited functional status. The questionnaire was to be completed by the participant prior to any procedures during the visit, if possible.
Overall HAQ-DI score was computed as the sum of domain scores divided by the number of domains answered, providing a score from 0-3. Low scores denoted improvement of disability/lower degree of domain difficulty.
Primary outcome reported in the table is mean HAQ-DI score at each time point, and it is on the scale of HAQ-DI score with the range from 0 to 3."|Week 1, 6, 13, and 25 (Course 1 and Course 2).|mITT Population - The mITT population for Course 2 was defined as all participants who received the treatments of the first 2 courses of study B3281004.||Score on a scale||Standard Deviation|Mean
674978|NCT01643928|Primary|Outcome Measure Using HAQ-DI - by the End of Course 1|"HAQ-DI assessed the degree of difficulty participants experienced in 8 daily living activity domains during a week: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consisted of 2-3 items. Each question’s difficulty was scored from 0-3 (0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do). Activities requiring assistance (from people or assistive devices) were adjusted to ≥2 to denote more limited functional status. The questionnaire was to be completed by the participant prior to any procedures during the visit, if possible.
Overall HAQ-DI score was computed as the sum of domain scores divided by the number of domains answered, providing a score from 0-3. Low scores denoted improvement of disability/lower degree of domain difficulty.
Primary outcome reported in the table is mean HAQ-DI score at each time point, and it is on the scale of HAQ-DI score with the range from 0 to 3."|Week 1, 6, 13, and 25 (Course 1).|mITT Population - The mITT population for Course 1 was defined as all participants who received the treatment of the first course of study B3281004.||Score on a scale||Standard Deviation|Mean
674979|NCT01643928|Primary|Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire – Disability Index (HAQ-DI) - by the End of Course 3|"HAQ-DI assessed the degree of difficulty participants experienced in 8 daily living activity domains during a week: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consisted of 2-3 items. Each question’s difficulty was scored from 0-3 (0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do). Activities requiring assistance (from people or assistive devices) were adjusted to ≥2 to denote more limited functional status. The questionnaire was to be completed by the participant prior to any procedures during the visit, if possible.
Overall HAQ-DI score was computed as the sum of domain scores divided by the number of domains answered, providing a score from 0-3. Low scores denoted improvement of disability/lower degree of domain difficulty.
Primary outcomes reported post baseline mean percent (%) changes in HAQ-DI score. Post baseline values are reported on the % change from initial study Baseline scale."|Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).|mITT Population - The mITT population for Course 3 was defined as all participants who received the treatments of all 3 courses of study B3281004.||Percent change in score||Standard Deviation|Mean
674988|NCT01643928|Primary|Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient’s Assessment of Arthritis Pain - by the End of Course 3|Participants assessed the severity of their arthritis pain using a 100 millimeter (mm) VAS by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.|Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).|mITT Population - The mITT population for Course 3 was defined as all participants who received the treatments of all 3 courses of study B3281004.||Percent change in score||Standard Deviation|Mean
675296|NCT01641640|Secondary|Percentage of Participants With Viral Relapse|Viral relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement.|End of treatment to post-treatment Week 24|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants|||Number
674980|NCT01643928|Primary|Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire – Disability Index (HAQ-DI) - by the End of Course 2|"HAQ-DI assessed the degree of difficulty participants experienced in 8 daily living activity domains during a week: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consisted of 2-3 items. Each question’s difficulty was scored from 0-3 (0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do). Activities requiring assistance (from people or assistive devices) were adjusted to ≥2 to denote more limited functional status. The questionnaire was to be completed by the participant prior to any procedures during the visit, if possible.
Overall HAQ-DI score was computed as the sum of domain scores divided by the number of domains answered, providing a score from 0-3. Low scores denoted improvement of disability/lower degree of domain difficulty.
Primary outcomes reported post baseline mean percent (%) changes in HAQ-DI score. Post baseline values are reported on the % change from initial study Baseline scale."|Week 1, 6, 13, and 25 (Course 1 and Course 2).|mITT Population - The mITT population for Course 2 was defined as all participants who received the treatments of the first 2 courses of study B3281004.||Percent change in score||Standard Deviation|Mean
674981|NCT01643928|Primary|Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire – Disability Index (HAQ-DI) - by the End of Course 1|"HAQ-DI assessed the degree of difficulty participants experienced in 8 daily living activity domains during a week: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consisted of 2-3 items. Each question’s difficulty was scored from 0-3 (0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do). Activities requiring assistance (from people or assistive devices) were adjusted to ≥2 to denote more limited functional status. The questionnaire was to be completed by the participant prior to any procedures during the visit, if possible.
Overall HAQ-DI score was computed as the sum of domain scores divided by the number of domains answered, providing a score from 0-3. Low scores denoted improvement of disability/lower degree of domain difficulty.
Primary outcomes reported post baseline mean percent (%) changes in HAQ-DI score. Post baseline values are reported on the % change from initial study Baseline scale."|Week 1, 6, 13, and 25 (Course 1).|mITT Population - The mITT population for Course 1 was defined as all participants who received the treatment of the first course of study B3281004.||Percent change in score||Standard Deviation|Mean
674982|NCT01643928|Primary|Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician’s Global Assessment of Arthritis - by the End of Course 3|The investigator assessed how the participant’s overall arthritis appeared at the time of the visit. This evaluation was based on the participant’s disease signs, functional capacity and physical examination, and was independent of the Patient’s Global Assessment of Arthritis. The investigator’s response was recorded using a 100 mm VAS by placing a mark on the scale between 0 (very good) and 100 (very poor).|Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).|mITT Population - The mITT population for Course 3 was defined as all participants who received the treatments of all 3 courses of study B3281004.||Percent change in score||Standard Deviation|Mean
674983|NCT01643928|Primary|Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician’s Global Assessment of Arthritis - by the End of Course 2|The investigator assessed how the participant’s overall arthritis appeared at the time of the visit. This evaluation was based on the participant’s disease signs, functional capacity and physical examination, and was independent of the Patient’s Global Assessment of Arthritis. The investigator’s response was recorded using a 100 mm VAS by placing a mark on the scale between 0 (very good) and 100 (very poor).|Week 1, 6, 13, and 25 (Course 1 and Course 2).|mITT Population - The mITT population for Course 2 was defined as all participants who received the treatments of the first 2 courses of study B3281004.||Percent change in score||Standard Deviation|Mean
674984|NCT01643928|Primary|Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician’s Global Assessment of Arthritis - by the End of Course 1|The investigator assessed how the participant’s overall arthritis appeared at the time of the visit. This evaluation was based on the participant’s disease signs, functional capacity and physical examination, and was independent of the Patient’s Global Assessment of Arthritis. The investigator’s response was recorded using a 100 mm VAS by placing a mark on the scale between 0 (very good) and 100 (very poor).|Week 1, 6, 13, and 25 (Course 1).|mITT Population - The mITT population for Course 1 was defined as all participants who received the treatment of the first course of study B3281004.||Percent change in score||Standard Deviation|Mean
674985|NCT01643928|Primary|Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient’s Global Assessment of Arthritis - by the End of Course 3|Participants were asked the following question, “Considering all the ways your arthritis affects you, how are you feeling today?” Their response was recorded using a 100 mm VAS between 0 (very well) and 100 (very poor).|Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).|mITT Population - The mITT population for Course 3 was defined as all participants who received the treatments of all 3 courses of study B3281004.||Percent change in score||Standard Deviation|Mean
674986|NCT01643928|Primary|Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient’s Global Assessment of Arthritis - by the End of Course 2|Participants were asked the following question, “Considering all the ways your arthritis affects you, how are you feeling today?” Their response was recorded using a 100 mm VAS between 0 (very well) and 100 (very poor).|Week 1, 6, 13, and 25 (Course 1 and Course 2).|mITT Population - The mITT population for Course 2 was defined as all participants who received the treatments of the first 2 courses of study B3281004.||Percent change in score||Standard Deviation|Mean
674987|NCT01643928|Primary|Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient’s Global Assessment of Arthritis - by the End of Course 1|Participants were asked the following question, “Considering all the ways your arthritis affects you, how are you feeling today?” Their response was recorded using a 100 mm VAS between 0 (very well) and 100 (very poor).|Week 1, 6, 13, and 25 (Course 1).|mITT Population - The mITT population for Course 1 was defined as all participants who received the treatment of the first course of study B3281004.||Percent change in score||Standard Deviation|Mean
675410|NCT01639729|Primary|CST 1/2|time for maximum plasma concentration to decrease by 50%|24 hours|The number of subjects (n) in Treatment D was less than the total 22 subjects for the following PK parameters: CST½ (n=16).||hours||Full Range|Median
674989|NCT01643928|Primary|Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient’s Assessment of Arthritis Pain - by the End of Course 2|Participants assessed the severity of their arthritis pain using a 100 millimeter (mm) VAS by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.|Week 1, 6, 13, and 25 (Course 1 and Course 2).|mITT Population - The mITT population for Course 2 was defined as all participants who received the treatments of the first 2 courses of study B3281004.||Percent change in score||Standard Deviation|Mean
674990|NCT01643928|Primary|Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient’s Assessment of Arthritis Pain - by the End of Course 1|Participants assessed the severity of their arthritis pain using a 100 millimeter (mm) VAS by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.|Week 1, 6, 13, and 25 (Course 1).|mITT Population - The mITT population for Course 1 was defined as all participants who received the treatment of the first course of study B3281004.||Percent change in score||Standard Deviation|Mean
674991|NCT01643928|Primary|Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3|Sixty-six joints were assessed by a blinded joint assessor for swelling. For consistency, a single assessor was preferred to perform all evaluations across the study for an individual participant. The response was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not be assessed.|Screening, Week 1, 6, 13, and 25 (Course 1 and Course 2), and Screening, Week 1, 13, and 25 (Course 3).|mITT Population - The mITT population for Course 3 was defined as all participants who received the treatments of all 3 courses of study B3281004.||Percent change in joint count||Standard Deviation|Mean
674992|NCT01643928|Primary|Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 2|Sixty-six joints were assessed by a blinded joint assessor for swelling. For consistency, a single assessor was preferred to perform all evaluations across the study for an individual participant. The response was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not be assessed.|Screening, Week 1, 6, 13, and 25 (Course 1 and Course 2).|mITT Population - The mITT population for Course 2 was defined as all participants who received the treatments of the first 2 courses of study B3281004.||Percent change in joint count||Standard Deviation|Mean
674993|NCT01643928|Primary|Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 1|Sixty-six joints were assessed by a blinded joint assessor for swelling. For consistency, a single assessor was preferred to perform all evaluations across the study for an individual participant. The response was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not be assessed.|Screening, Week 1, 6, 13, and 25 (Course 1).|mITT Population - The mITT population for Course 1 was defined as all participants who received the treatment of the first course of study B3281004.||Percent change in joint count||Standard Deviation|Mean
674994|NCT01643928|Primary|Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3|Sixty-eight joints were assessed by a blinded joint assessor to determine the number of joints that were considered tender or painful. For consistency, a single assessor was preferred to perform all evaluations across the study for an individual participant. The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not be assessed.|Screening, Week 1, 6, 13, and 25 (Course 1 and Course 2), and Screening, Week 1, 13, and 25 (Course 3).|mITT Population - The mITT population for Course 3 was defined as all participants who received the treatments of all 3 courses of study B3281004.||Percent change in joint count||Standard Deviation|Mean
674995|NCT01643928|Primary|Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 2|Sixty-eight joints were assessed by a blinded joint assessor to determine the number of joints that were considered tender or painful. For consistency, a single assessor was preferred to perform all evaluations across the study for an individual participant. The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not be assessed.|Screening, Week 1, 6, 13, and 25 (Course 1 and Course 2).|mITT Population - The mITT population for Course 2 was defined as all participants who received the treatments of the first 2 courses of study B3281004.||Percent change in joint count||Standard Deviation|Mean
674996|NCT01643928|Primary|Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 1|Sixty-eight joints were assessed by a blinded joint assessor to determine the number of joints that were considered tender or painful. For consistency, a single assessor was preferred to perform all evaluations across the study for an individual participant. The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not be assessed.|Screening, Week 1, 6, 13, and 25 (Course 1).|mITT Population - The mITT population for Course 1 was defined as all participants who received the treatment of the first course of study B3281004.||Percent change in joint count||Standard Deviation|Mean
674997|NCT01643928|Primary|Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 3|ACR70 response: ≥70% improvement in tender/painful joint count; ≥70% improvement in swollen joint count; and ≥70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the HAQ); and CRP.|Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).|mITT Population - The mITT population for Course 3 was defined as all participants who received the treatments of all 3 courses of study B3281004.||Percentage of Participants|||Number
675025|NCT01643928|Primary|Percentage of Participants by Neutralizing Antibody (Nab) Status in Participants With a Positive ADA Using Anti-PF-05280586 NAb Assay|Blood samples that were confirmed as positive for ADA were further evaluated for Nab using validated assays - None of the ADA samples tested positive for NAb.|Weeks 1, 3, 13, and 25 (Course 1, Course 2, and Course 3).|mITT Population. Only participants with a positive ADA status were included in the analysis.|||||
674998|NCT01643928|Primary|Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 2|ACR70 response: ≥70% improvement in tender/painful joint count; ≥70% improvement in swollen joint count; and ≥70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the HAQ); and CRP.|Week 1, 6, 13, and 25 (Course 1 and Course 2).|mITT Population - The mITT population for Course 2 was defined as all participants who received the treatments of the first 2 courses of study B3281004.||Percentage of Participants|||Number
674999|NCT01643928|Primary|Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 1|ACR70 response: ≥70% improvement in tender/painful joint count; ≥70% improvement in swollen joint count; and ≥70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the HAQ); and CRP.|Week 1, 6, 13, and 25 (Course 1).|mITT Population - The mITT population for Course 1 was defined as all participants who received the treatment of the first course of study B3281004.||Percentage of Participants|||Number
675000|NCT01643928|Primary|Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 3|ACR50 response: ≥50% improvement in tender/painful joint count; ≥50% improvement in swollen joint count; and ≥50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the HAQ); and CRP.|Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).|mITT Population - The mITT population for Course 3 was defined as all participants who received the treatments of all 3 courses of study B3281004.||Percentage of Participants|||Number
675001|NCT01643928|Primary|Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 2|ACR50 response: ≥50% improvement in tender/painful joint count; ≥50% improvement in swollen joint count; and ≥50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the HAQ); and CRP.|Week 1, 6, 13, and 25 (Course 1 and Course 2).|mITT Population - The mITT population for Course 2 was defined as all participants who received the treatments of the first 2 courses of study B3281004.||Percentage of Participants|||Number
675002|NCT01643928|Primary|Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 1|ACR50 response: ≥50% improvement in tender/painful joint count; ≥50% improvement in swollen joint count; and ≥50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the HAQ); and CRP.|Week 1, 6, 13, and 25 (Course 1).|mITT Population - The mITT population for Course 1 was defined as all participants who received the treatment of the first course of study B3281004.||Percentage of Participants|||Number
675003|NCT01643928|Primary|Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 3|ACR20 response: ≥ 20 percent (%) improvement in tender/painful joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and CRP.|Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).|mITT Population - The mITT population for Course 3 was defined as all participants who received the treatments of all 3 courses of study B3281004.||Percentage of participants|||Number
675004|NCT01643928|Primary|Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 2|ACR20 response: ≥ 20 percent (%) improvement in tender/painful joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and CRP.|Week 1, 6, 13, and 25 (Course 1 and Course 2).|mITT Population - The mITT population for Course 2 was defined as all participants who received the treatments of the first 2 courses of study B3281004.||Percentage of participants|||Number
675005|NCT01643928|Primary|Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 1|ACR20 response: ≥ 20 percent (%) improvement in tender/painful joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and CRP.|Week 1, 6, 13, and 25 (Course 1).|mITT Population - The mITT population for Course 1 was defined as all participants who received the treatment of the first course of study B3281004.||Percentage of participants|||Number
675006|NCT01643928|Primary|Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 3|The DAS assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient’s global assessment of arthritis VAS. The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP = 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 (ln CRP [mg/L] +1) + 0.014 (GH) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP <2.6 implied remission.|Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).|mITT Population - The mITT population for Course 3 was defined as all participants who received the treatments of all 3 courses of study B3281004.||Percentage of Participants|||Number
675237|NCT01641939|Secondary|Maximum Observed Plasma Concentration (Cmax) of Trastuzumab Emtansine (T-DM1) and Total Trastuzumab - Stage 2|Stage 2 consists of all participants recruited after the regimen selection decision up to primary data cut-off date 30-June-2015.|C1D1; C4D1|Participants who had at least one PK parameter estimated were included for analysis. Here, n=number of participants evaluable at specified timepoint.||mcg/mL||Standard Deviation|Mean
675007|NCT01643928|Primary|Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 2|The DAS assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient’s global assessment of arthritis VAS. The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP = 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 (ln CRP [mg/L] +1) + 0.014 (GH) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP <2.6 implied remission.|Week 1, 6, 13, and 25 (Course 1 and Course 2).|mITT Population - The mITT population for Course 2 was defined as all participants who received the treatments of the first 2 courses of study B3281004.||Percentage of Participants|||Number
675008|NCT01643928|Primary|Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 1|The DAS assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient’s global assessment of arthritis VAS. The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP = 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 (ln CRP [mg/L] +1) + 0.014 (GH) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP <2.6 implied remission.|Week 1, 6, 13, and 25 (Course 1).|mITT Population - The mITT population for Course 1 was defined as all participants who received the treatment of the first course of study B3281004.||Percentage of Participants|||Number
675009|NCT01643928|Primary|Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 3|The DAS assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient’s global assessment of arthritis VAS. The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP = 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 (ln CRP [mg/L] +1) + 0.014 (GH) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP ≤3.2 implied low disease activity.|Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).|mITT Population - The mITT population for Course 3 was defined as all participants who received the treatments of all 3 courses of study B3281004.||Percentage of Participants|||Number
675010|NCT01643928|Primary|Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 2|The DAS assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient’s global assessment of arthritis VAS. The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP = 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 (ln CRP [mg/L] +1) + 0.014 (GH) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP ≤3.2 implied low disease activity.|Week 1, 6, 13, and 25 (Course 1 and Course 2).|mITT Population - The mITT population for Course 2 was defined as all participants who received the treatments of the first 2 courses of study B3281004.||Percentage of Participants|||Number
675011|NCT01643928|Primary|Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 1|The DAS assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient’s global assessment of arthritis VAS. The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP = 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 (ln CRP [mg/L] +1) + 0.014 (GH) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP ≤3.2 implied low disease activity.|Week 1, 6, 13, and 25 (Course 1).|mITT Population - The mITT population for Course 1 was defined as all participants who received the treatment of the first course of study B3281004.||Percentage of Participants|||Number
675012|NCT01643928|Primary|Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 3|The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders had a change from baseline greater than (>) 1.2 with present DAS28 less than or equal to (≤) 3.2; moderate responders had a change from baseline >0.6 and ≤1.2 with present DAS28 ≤3.2 or change from baseline >0.6 with present DAS28 >3.2 and ≤5.1 or change from baseline >1.2 with present DAS28 >5.1; non-responders had a change from baseline ≤0.6 with present DAS28 ≤5.1 or change from baseline ≤1.2 with present DAS28 >5.1.|Week 1, 6, 13, and 25 (Course 1 and Course 2) and Week 1, 13, and 25 (Course 3).|mITT Population - The mITT population for Course 3 was defined as all participants who received the treatments of all 3 courses of study B3281004.||Percentage of Participants|||Number
675013|NCT01643928|Primary|Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 2|The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders had a change from baseline greater than (>) 1.2 with present DAS28 less than or equal to (≤) 3.2; moderate responders had a change from baseline >0.6 and ≤1.2 with present DAS28 ≤3.2 or change from baseline >0.6 with present DAS28 >3.2 and ≤5.1 or change from baseline >1.2 with present DAS28 >5.1; non-responders had a change from baseline ≤0.6 with present DAS28 ≤5.1 or change from baseline ≤1.2 with present DAS28 >5.1.|Week 1, 6, 13, and 25 (Course 1 and Course 2).|mITT Population - The mITT population for Course 2 was defined as all participants who received the treatments of the first 2 courses of study B3281004.||Percentage of Participants|||Number
675037|NCT01643668|Secondary|Cumulative Incidence of Chronic GVHD at One Year|The percentage of participants who experienced chronic Graft Versus Host Disease (GVHD) by one year. GVHD is a condition that can occur following an allogenic stem cell transplantation when the donated bone marrow or peripheral stem cells view the recipients body as foreign and the donated cell/marrow attack the body. Chronic GVHD normally occurs after the first 100 days post transplantation. Chronic GVHD can adversely influence long term survival.|1 year|||percentage of participants||95% Confidence Interval|Number
675411|NCT01639729|Primary|Tmax|time to maximum plasma concentration|24 hours|||hours||Full Range|Median
675412|NCT01639729|Primary|Cmax|maximum plasma concentration|24 hours|||pg/mL||Standard Deviation|Mean
675014|NCT01643928|Primary|Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 1|The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders had a change from baseline greater than (>) 1.2 with present DAS28 less than or equal to (≤) 3.2; moderate responders had a change from baseline >0.6 and ≤1.2 with present DAS28 ≤3.2 or change from baseline >0.6 with present DAS28 >3.2 and ≤5.1 or change from baseline >1.2 with present DAS28 >5.1; non-responders had a change from baseline ≤0.6 with present DAS28 ≤5.1 or change from baseline ≤1.2 with present DAS28 >5.1.|Week 1, 6, 13, and 25 (Course 1).|mITT Population - The mITT population for Course 1 was defined as all participants who received the treatment of the first course of study B3281004.||Percentage of Participants|||Number
675015|NCT01643928|Primary|Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3|The disease activity score (DAS) assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient’s global assessment of arthritis Visual Analog Scale (VAS). The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP equals (=) 0.56 square root (sqrt) (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 natural log [ln] (CRP [milligrams per liter, mg/L] +1) + 0.014 (global assessment of health [GH]) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity.|Baseline B3281001, Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).|mITT Population - The mITT population for Course 3 was defined as all participants who received the treatments of all 3 courses of study B3281004.||Units on a scale||Standard Deviation|Mean
675016|NCT01643928|Primary|Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 2|The disease activity score (DAS) assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient’s global assessment of arthritis Visual Analog Scale (VAS). The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP equals (=) 0.56 square root (sqrt) (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 natural log [ln] (CRP [milligrams per liter, mg/L] +1) + 0.014 (global assessment of health [GH]) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity.|Baseline B3281001, Week 1, 6, 13, and 25 (Course 1 and Course 2).|mITT Population - The mITT population for Course 2 was defined as all participants who received the treatments of the first 2 courses of study B3281004.||Units on a scale||Standard Deviation|Mean
675017|NCT01643928|Primary|Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 1|The disease activity score (DAS) assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient’s global assessment of arthritis Visual Analog Scale (VAS). The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP equals (=) 0.56 square root (sqrt) (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 natural log [ln] (CRP [milligrams per liter, mg/L] +1) + 0.014 (global assessment of health [GH]) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity.|Baseline B3281001, Week 1, 6, 13, and 25 (Course 1).|mITT Population - The mITT population for Course 1 was defined as all participants who received the treatment of the first course of study B3281004.||Units on a scale||Standard Deviation|Mean
675018|NCT01643928|Primary|Anti-Cyclic Citrullinated Peptide (Anti-CCP) and Complement|Blood samples were obtained to determine anti-CCP and compliment levels in serum.|Week 1 and 25 (Course 1, Course 2, and Course 3).|mITT Population - mITT populations for Courses 1, 2 and 3 were defined as all participants who received the first course, first 2 courses and all 3 courses of treatment respectively.||U/mL||Standard Deviation|Mean
675019|NCT01643928|Primary|Circulating Rheumatoid Factor (RF) Concentrations|RF is the auto-antibody directed against IgG. Blood samples were obtained to determine RF levels in serum.|Week 1 and 25 (Course 1, Course 2, and Course 3).|mITT Population - mITT populations for Courses 1, 2 and 3 were defined as all participants who received the first course, first 2 courses and all 3 courses of treatment respectively.||international units per milliliter||Standard Deviation|Mean
675020|NCT01643928|Primary|Circulating Immunoglobulin M (IgM) Concentrations|Blood samples for immunoglobulin assessments were obtained to determine IgM levels in serum.|Screening, Week 25 (Course 1), and Weeks 1 and 25 (Course 2 and Course 3).|mITT Population - mITT populations for Courses 1, 2 and 3 were defined as all participants who received the first course, first 2 courses and all 3 courses of treatment respectively.||g/L||Standard Deviation|Mean
675021|NCT01643928|Primary|Circulating Immunoglobulin G (IgG) Concentrations|Blood samples for immunoglobulin assessments were obtained to determine IgG levels in serum.|Screening, Week 25 (Course 1), and Weeks 1 and 25 (Course 2 and Course 3).|mITT Population - mITT populations for Courses 1, 2 and 3 were defined as all participants who received the first course, first 2 courses and all 3 courses of treatment respectively.||grams per liter (g/L)||Standard Deviation|Mean
675022|NCT01643928|Primary|Cluster of Differentiation 19 (CD19+) B Cell Count|Blood samples were assayed for CD19+ B-cell counts using laser scanning cytometry.|Weeks 1, 6, 13, and 25 (Course 1 and Course 2), Weeks 1, 13, 25 (Course 3), and Follow up Months 3, 6, and 9.|mITT Population - mITT populations for Courses 1, 2 and 3 were defined as all participants who received the first course, first 2 courses and all 3 courses of treatment respectively.||cells per microliter||Full Range|Median
675023|NCT01643928|Primary|Mean Rituximab Serum Trough Concentrations|Serum samples for determination of drug concentrations were collected pre-dose concurrent with ADA sample collection. Drug concentrations in the samples were determined using a validated assay.|Weeks 1, 3, 13, and 25 (Course 1, Course 2, and Course 3), Follow up Months 3, 6, 9, and 12. Course 3/Week 25 is End of Treatment (EOT).|mITT Population - mITT populations for Courses 1, 2 and 3 were defined as all participants who received the first course, first 2 courses and all 3 courses of treatment respectively.||nanograms per milliliter||Standard Deviation|Mean
675024|NCT01643928|Primary|Percentage of Participants by Nab Status in Participants With a Positive ADA Using Anti-PF-05280586 NAb Assay Using Anti-Rituximab NAb Assay|Blood samples that were confirmed as positive for ADA were further evaluated for Nab using validated assays. - None of the ADA samples tested positive for NAb.|Weeks 1, 3, 13, and 25 (Course 1, Course 2, and Course 3).|mITT Population. Only participants with a positive ADA status were included in the analysis.|||||
675026|NCT01643928|Primary|Percentage of Participants by ADA Status Using Anti-Rituximab Antibody Assay|Serum samples were collected to determine the presence of ADA using two validated assays, one specific for PF-05280586 and one specific for the licensed drug products. For participants assigned to PF-05280586 in Study B3281001, blood samples were screened for ADA using the assay specific to PF-05280586; if the blood samples were confirmed to be positive for ADA against PF-05280586, the samples were also analyzed using the assay specific for the licensed drug products to assess cross-reactivity of the ADA. For participants assigned to the licensed products in Study B3281001, blood samples were screened for ADA using both assays in order to assess any product-specific ADA and/or cross-reactivity for the transition from the licensed products to PF-05280586.|Course 1 Overall, Course 2 Overall, Course 3 Overall, and All Courses Overall.|mITT population - mITT populations for Courses 1, 2 and 3 were defined as all participants who received the first course, first 2 courses and all 3 courses of treatment respectively. Only participants with a positive ADA status were included in the analysis.||Percentage of Participants|||Number
675027|NCT01643928|Primary|Percentage of Participants by Anti-Drug Antibody (ADA) Status Using Anti-PF-05280586 Antibody Assay|Serum samples were collected to determine the presence of ADA using two validated assays, one specific for PF-05280586 and one specific for the licensed drug products. For participants assigned to PF-05280586 in Study B3281001, blood samples were screened for ADA using the assay specific to PF-05280586; if the blood samples were confirmed to be positive (+ve) for ADA against PF-05280586, the samples were also analyzed using the assay specific for the licensed drug products to assess cross-reactivity of the ADA. For participants assigned to the licensed products in Study B3281001, blood samples were screened for ADA using both assays in order to assess any product-specific ADA and/or cross-reactivity for the transition from the licensed products to PF-05280586.|Course 1 (C1) Overall, Course 2 (C2) Overall, Course 3 (C3) Overall, and All Courses Overall.|Modified intent-to-treat (mITT) population - mITT populations for Courses 1, 2 and 3 were defined as all participants who received the first course, first 2 courses and all 3 courses of treatment respectively. Only participants with a positive ADA status were included in the analysis.||Percentage of Participants|||Number
675028|NCT01643902|Secondary|Functional Outcome by the Modified Rankin Scale at 90 Days|"The modified Rankin scale (mRS) is a scale of disability after stroke, with a range of 0 to 6.
0, no symptoms at all.
no significant disability despite symptoms; able to carry out all usual duties and activities.
slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance.
moderate disability; requiring some help, but able to walk without assistance.
moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance.
severe disability; bedridden, incontinent and requiring constant nursing care and attention.
dead."|90 days|||units on a scale||Full Range|Mean
675029|NCT01643902|Primary|Number of Participants With Symptomatic Intracerebral Hemorrhage Within 36 Hours of Treatment|"Symptomatic intracerebral hemorrhage by using the European Cooperative Acute Stroke Study (ECASS) 3 criteria as well as the original National Institutes of Neurological Disorders and Stroke (NINDS) Intravenous tissue plasminogen activator (IV tPA) trial criteria for comparison.
ECASS 3 criteria: hemorrhage in brain imaging, and an increase of 4 or more points on the National Institutes of Health Stroke Scale (NIHSS) from baseline.
NINDS IV tPA trial criteria: a hemorrhage not seen in previous brain imaging, associated with a neurological decline attributable to the hemorrhage."|within 36 hours of treatment|No symptomatic intracerebral hemorrhage was observed by either NINDS IV tPA trial or ECASS 3 criteria.||participants|||Number
675030|NCT01643876|Secondary|Candida Species Count|Candida colony forming units (CFU), defined as the number of colonies formed on a 75 mm agar plate inoculated with collected samples obtained from A)plaque formed on denture surface and B)palatal mucosa.|3 months|||colony forming units (CFUs)||Full Range|Median
675031|NCT01643876|Primary|Palatal Inflammation|"Modified Newton classification 0: Healthy mucosa
1: Type IA, Petechiae in a normal palatal tissue, which are usually found around the orifices of the ducts of the palatal mucous glands 2: Type IB, Localized area of inflammation of the denture-bearing area 3: Type II, Generalised area of inflammation of the denture-bearing area 4: Type III, Hyperplasic palatal surface with inflammation of the denture-bearing area Inflammation area index 0: No inflammation
Inflammation of the palate extending up to 25 % of the palatal denture-bearing tissue
Inflammation of the palate extending between 25 % and 50 % of the palatal denture-bearing tissue
Inflammation covering more than 50 % of the palatal denture-bearing tissue Inflammation severity index
0: Normal tissue
Mild inflammation
Moderate inflammation
Severe inflammation Total score for inflammation = area + intensity (range 0 to 6)"|3 months|||units on a scale||Full Range|Median
675032|NCT01643798|Primary|Change in BOLD Signal in Pain Processing Regions During Pain, Including Supraspinal Opioidergic Structures|There are two experimental visits separated by one week. During each experiment, blood oxygen level dependent (BOLD) signal will be measured at baseline (60 minutes into the experiment), post-sham rTMS (90 minutes into the experiment) and post-real (120 minutes into the experiment).|Baseline (60 minutes into experiment), Post-Sham (90 minutes), Post-Real (120 minutes)|||mean percentage of BOLD signal change||Standard Error|Mean
675033|NCT01643798|Primary|Pain Rating|"There are two experimental visits separated by one week. During each experiment, pain ratings will be measured every 30 minutes. Preliminary testing will be done 30 minutes into the experiment. The purpose of preliminary testing is to select the temperature that will be used to induce pain throughout the experiment. Baseline testing will be done 60 minutes into the experiment. After sham rTMS will be done 90 minutes into the experiment. After real rTMS will be done 120 minutes into the study. The pain scale used in a Visual Analog Scale (VAS). There was an 11-point rating system where 0 represented no pain and 10 represented unbearable pain."|Baseline (60 minutes into experiment), Post-Sham (90 minutes), Post-Real (120 minutes)|||units on a scale||Standard Error|Mean
675034|NCT01643668|Secondary|Infection-related Complications|The number of patients with infection-related complications|2 years|||Participants|||Count of Participants
675035|NCT01643668|Secondary|Grade 3 or 4 Toxicities|The number of participants that experienced the specified grade 3 and 4 non-hematological toxicities during treatment and follow-up as assessed by Common Terminology Criteria for Adverse Events version 4(CTAE v 4.0). Grade 3 toxicity is considered to be severe and grade 4 is considered to be life threatening.|2 years|||Participants|||Count of Participants
675036|NCT01643668|Secondary|Incidence of Hepatic Veno-occlusive Disease|The number of participants that experienced hepatic veno-occlusive disease (VOD). VOD is a condition in which some of the small veins in the liver are obstructed.|2 years|||Participants|||Count of Participants
675038|NCT01643668|Secondary|Cumulative Incidence and Severity of Acute GVHD Within 100 Days Post Transplant|The percentage of participants who experienced grades 2-4 and grades 3-4 acute graft-versus-host disease (GVHD) by 100 days post transplantation. GVHD is a condition that can occur following an allogenic stem cell transplantation when the donated bone marrow or peripheral stem cells view the recipients body as foreign and the donated cell/marrow attack the body. Acute GVHD is generally observed within the first 100 days post transplant. Acute GVHD is associated with increased treatment related morbidity and mortality. Grade I GVHD is characterized as mild disease, grade II GVHD as moderate, grade III as severe, and grade IV life-threatening. The grade of the GVHD is determined by grading GHVD associated adverse events. Associated adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4 which uses the same mild, moderate, severe, life threatening grading system as the overall GHVD assessment.|100 days|||percentage of Participants||95% Confidence Interval|Number
675039|NCT01643668|Secondary|Progression-Free and Overall Survival|The 1-year and 2-year progression-free and overall survival measured from the time of stem cell transplantation. Progression is the recurrence or increase in the number of cancer cells found in the body.|1 year, 2 years|||percentage of participants||95% Confidence Interval|Number
675040|NCT01643668|Secondary|Cumulative Incidence of Non-relapse Mortality|The percentage of participants that experienced non-relapse mortality (NRM) at day 100 and 1 year after BuClo RIC SCT. Non-relapse mortality is any mortality that is not associated with or proceeded by disease progression of prior cancers.|100 days, 1 year|||percentage of participants who died||95% Confidence Interval|Number
675041|NCT01643668|Primary|Donor Stem Cell Engraftment: Platelet Count|Platelet recovery was defined as having a platelet count of at least 20,000 platelets/uL of blood on 2 consecutive measurements without transfusional support prior to day +100 after BuClo RIC HSCT.|1, 2, 3, 4, 8, and 14 weeks post transplant|One participant experienced early death before engraftment. Outcome measure was assessed among the remaining 33 evaluable participants.||Participants|||Count of Participants
675042|NCT01643668|Primary|Assessment of Donor Stem Cell Engraftment: ANC Count|Patients are considered to have achieved donor cell engraftment if they have an absolute neutrophil count (ANC) of at least 500 cells/uL of blood for 3 consecutive measurements and at least 75% of hematopoietic elements are donor-derived as determined by chimerism assays from peripheral blood prior to day +40 after Busulfan/Clofarabine (BuClo) reduced intensity allogeneic stem cell transplantation|1, 2, 3, and 4 weeks after transplantation|One participant experienced early death before engraftment. Outcome measure was assessed among the remaining 33 evaluable participants.||Participants|||Count of Participants
675043|NCT01643616|Primary|Success Rate With Supplementation|"After injection of local anesthetic a waiting period of 30-60 minutes was defined before completing a failed block.
success without supplementation = no additional analgetics or rescue blocks required (success rate without supplementation, outcome measure 1)
success with supplementation = analgetics or selective rescue blocks distal of the sciatic division required (success rate without supplementation and additionally all supplemented blocks, outcome measure 3)
failed block = change of anesthetic procedure (general, spinal) or rescue blocks proximal of the sciatic divisionSucces rate with supplementation"|later than 30-60 minutes after injection of the local anesthetic|||participants|||Number
675044|NCT01643616|Primary|Time Until Readiness for Surgery (Minutes)||within 60 minutes after injection of the local anesthetic|||minutes||95% Confidence Interval|Mean
675045|NCT01643616|Primary|Success Rate Without Supplementation|"After injection of local anesthetic a waiting period of 30-60 minutes was defined before completing a failed block.
success without supplementation = no additional analgetics or rescue blocks required (success rate without supplementation, outcome measure 1)
success with supplementation = analgetics or selective rescue blocks distal of the sciatic division required (success rate without supplementation and additionally all supplemented blocks, outcome measure 3)
failed block = change of anesthetic procedure (general, spinal) or rescue blocks proximal of the sciatic division"|within 30-60 minutes after injection of the local anesthetic|In the NS group two investigators were necessary in order to realize the blinded study protocol. For personnel reasons this was not possible in every case and led to deviations from the randomization protocol for seven patients in each group. These patients were excluded from the analysis.||participants|||Number
675046|NCT01643525|Secondary|Nautilus NeuroWaveTM Recording in MRI Normal Population (no Cerebrovascular Disease Per MRI)||At study completion- approximately 8 months||||||
675047|NCT01643525|Secondary|Incidence of Device Related Adverse Events||At study completion- approximately 8 months||||||
675048|NCT01643525|Secondary|Determine the Location to Left, Right, Deep, and/or Back of the Cranium||At study completion- approximately 8 months||||||
675049|NCT01643525|Primary|Sensitivity, Specificity and Predictive Values of the Jan Medical DC1 System in Detecting Ischemia Within 12 Hours of Known Stroke Onset in Comparison to Follow up CT and MRI.||At study completion- approximately 8 months|Terminated study, data incomplete. Data not analyzed.|||||
675050|NCT01643213|Primary|Subject's Treatment Preference|Subject were asked if he/she prefers their current period SCS therapy over the SCS therapy he/she received during the SCS trial period prior to Baseline|30 minutes after activation of stimulation|||participants|||Number
675051|NCT01643044|Primary|Alcohol Use|Alcohol use will be measured at the time of delivery of their infant by self-report and urine analysis. The number represents the number of participants who were abstinent (reported no alcohol use and had a negative toxicology urine screen) from alcohol for the past 90 days.|self-reported use during 90 days prior to delivery of their baby|||participants|||Number
675052|NCT01642914|Primary|9/12 Week Complete Spontaneous Bowel Movement (CSBM) 3+1 Responder|A 9/12 Week CSBM 3+1 Responder is a patient who is a CSBM 3+1 Weekly Responder for at least 9 out of the 12 weeks of the Treatment Period. A CSBM 3+1 Weekly Responder is a patient who had a CSBM Weekly Frequency Rate that was 3 or greater and increased by 1 or more from baseline.|12-week treatment period|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population||participants|||Number
675413|NCT01639729|Primary|AUC (0 - Inf)|total amount of sufentanil absorbed|24 hours|A The number of subjects (n) in Treatment D was less than the total 22 subjects for the following PK parameters: AUC 0-inf (n=18).||h.pg/mL||Standard Deviation|Mean
675053|NCT01642914|Secondary|9/12 Week Mild Straining and Diarrhea-free Responder|"A patient was a 9/12 week mild straining and diarrhea-free responder if that patient met the weekly criterion for at least 9 weeks of the 12-week treatment period. A patient was considered to have met the weekly criterion in a given week if that patient had a nonmissing average straining score ≤ 2 (where a value of 1 represents no straining, an a value of 5 represents an extreme amount of straining), and the patient had no diarrhea adverse event (AE) reported for that week.
Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|12-week treatment period|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population||participants|||Number
675054|NCT01642914|Secondary|Change From Baseline in Severity of Straining at Week 12|"Severity of straining was measured using a 5-point ordinal scale, where of value of 1 is “not at all” and a value of 5 is “an extreme amount.”
A patient’s straining score for baseline was derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient’s straining score at Week 12 was the average of the nonmissing straining scores from the SBMs reported by that patient during analysis Week 12.
Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|Baseline and Week 12|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population||units on a scale||Standard Deviation|Mean
675055|NCT01642914|Secondary|Change From Baseline in 12-week Severity of Straining|"Severity of straining was measured using a 5-point ordinal scale, where of value of 1 is “not at all” and a value of 5 is “an extreme amount.” A patient’s straining score for baseline was derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient’s straining score for the treatment period was the average of the nonmissing straining scores from the SBMs reported by the patient during the 12-week treatment period.
Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|Baseline and 12-week treatment period|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population||units on a scale||Standard Deviation|Mean
675056|NCT01642914|Secondary|Change From Baseline in Stool Consistency at Week 12|"Stool consistency was measured using the 7-point Bristol Stool Form Scale (BSFS):
= separate hard lumps like nuts [difficult to pass]
= sausage shaped but lumpy
= like a sausage but with cracks on surface
= like a sausage or snake, smooth and soft
= soft blobs with clear-cut edges [passed easily]
= fluffy pieces with ragged edges, a mushy stool
= watery, no solid pieces [entirely liquid]
A patient’s BSFS score for the baseline period (14 days before randomization, up to the time of randomization) and at week 12, was the average of the nonmissing BSFS scores from the SBMs reported by the patient during the respective baseline period and during Week 12.
Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|Baseline and Week 12|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population||units on a scale||Standard Deviation|Mean
675057|NCT01642914|Secondary|Change From Baseline in 12-week Stool Consistency|"Stool consistency was measured using the 7-point Bristol Stool Form Scale (BSFS):
= separate hard lumps like nuts [difficult to pass]
= sausage shaped but lumpy
= like a sausage but with cracks on surface
= like a sausage or snake, smooth and soft
= soft blobs with clear-cut edges [passed easily]
= fluffy pieces with ragged edges, a mushy stool
= watery, no solid pieces [entirely liquid]
A patient’s BSFS score for the baseline period (14 days before randomization, up to the time of randomization) and for the 12-week treatment period, was the average of the nonmissing BSFS scores from the SBMs reported by the patient during the respective baseline and treatment periods.
Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|Baseline and 12-week treatment period|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population||units on a scale||Standard Deviation|Mean
675078|NCT01642615|Secondary|Percent of Days With Neither Daytime Nor Nighttime Heartburn Over Weeks 8 to 24|The percent of days with neither daytime nor nighttime heartburn over Weeks 8 to 24 as assessed by electronic daily diary among the participants who were healed at Week 8. The percent of days with neither daytime or nighttime heartburn = (total number of days that are heartburn free)/(total number of days for which either a daytime or nighttime result is marked) x 100%.|Weeks 8 to 24|Participants from the Full Analysis Set, all participants with healed EE at Week 8 who were randomized and received at least one dose of open-label study drug in Weeks 8 to 24.||percent of days||Standard Deviation|Mean
676263|NCT01627561|Secondary|Vaccine Response Rates to Filamentous Haemagglutinin (FHA), Pertactin (PRN) and Pertussis Toxoid (PT) Antigens in Groups HPV_2D, MMR_DTPa and HPV_2D CO.||At Month 7||12/2016||||
675058|NCT01642914|Secondary|Time to Spontaneous Bowel Movement (SBM) After the First Dose of Investigational Product|"Time to first SBM after the first dose of investigation product was defined as the number of hours between the time of the first dose of investigational product to the occurrence of the first SBM. Patients who did not achieve an SBM were considered censored, with time to censoring defined as the number of hours elapsing from the time of the first dose of investigational product was taken to the end of the day of the last dose, at 12:00 AM (24:00 military time).
Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|12-week treatment period|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population||Hours||95% Confidence Interval|Median
675059|NCT01642914|Secondary|SBM Within 24 Hours After the First Dose of Investigational Product|"The proportion of patients with a SBM within 24 hours of first taking investigational product in each linaclotide dose group was compared with the proportion in the placebo group using the Cochran-Mantel-Haenszel (CMH) test controlling for geographic region.
Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|24 hours from first dose of investigational product (Day 1)|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population||participants|||Number
675060|NCT01642914|Secondary|Change From Baseline in the Number of Days With a Spontaneous Bowel Movement (SBM)|"A patient's baseline number of days with a Spontaneous Bowel Movement (SBM) was calculated as the number of days with at least 1 Spontaneous Bowel Movement (SBM), derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's number of days with a SBM during the Treatment Period was calculated as the number of days with at least 1 Spontaneous Bowel Movement (SBM), divided by treatment duration (in days), and multiplied by 7.
Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|Baseline and 12-week treatment period|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population||Days per week||Standard Deviation|Mean
675061|NCT01642914|Secondary|Change From Baseline in SBM Frequency Rate at Week 12|"A patient’s baseline SBM frequency rate is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient’s SBM frequency rate at week 12 was the SBM rate (SBMs/week) calculated over that week.
Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|Baseline and Week 12|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population||SBMs per week||Standard Deviation|Mean
675062|NCT01642914|Secondary|Change From Baseline in SBM Frequency Rate at Week 8|"A patient’s baseline SBM frequency rate is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient’s SBM frequency rate at Week 8 was the SBM rate (SBMs/week) calculated over that week.
Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|Baseline and Week 8|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population||SBMs per week||Standard Deviation|Mean
675063|NCT01642914|Secondary|Change From Baseline in SBM Frequency Rate at Week 4|"A patient’s baseline SBM frequency rate is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient’s SBM frequency rate at Week 4 was the SBM rate (SBMs/week) calculated over that week.
Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|Baseline and Week 4|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population||SBMs per week||Standard Deviation|Mean
675079|NCT01642615|Secondary|Percent of Days With Neither Daytime Nor Nighttime Heartburn Over the First 8 Weeks of Treatment|Percent of days with neither daytime nor nighttime heartburn over the first 8 weeks of treatment as assessed by electronic daily diary. The percent of days with neither daytime or nighttime heartburn = (total number of days that are heartburn free)/(total number of days for which either a daytime or nighttime result is marked) x 100%.|8 weeks|Participants from the Full Analysis Set, all enrolled participants who received at least one dose of open-label study drug in the first 8 weeks, with data available for analysis.||percent of days||Standard Deviation|Mean
675064|NCT01642914|Secondary|Change From Baseline in SBM Frequency Rate at Week 1|"A patient’s baseline SBM frequency rate is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient’s SBM frequency rate at week 1 was the SBM rate (SBMs/week) calculated over that week.
Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|Baseline and Week 1|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population||SBMs per week||Standard Deviation|Mean
675065|NCT01642914|Secondary|Change From Baseline in 12-Week SBM Frequency Rate|"A patient’s Baseline SBM frequency rate is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient’s 12-week SBM frequency rate was the SBM rate (SBMs/week) calculated over the 12 weeks of the treatment period.
Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|12-week treatment period|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population||SBMs per week||Standard Deviation|Mean
675066|NCT01642914|Secondary|Change From Baseline in CSBM Frequency Rate at Week 12|"A patient’s CSBM frequency rate from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient’s CSBM frequency rate at week 12 was the CSBM rate (CSBMs/week) calculated over that week.
Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|Baseline and Week 12|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population||CSBMs per week||Standard Deviation|Mean
675067|NCT01642914|Secondary|Change From Baseline in CSBM Frequency Rate at Week 8|"A patient’s CSBM frequency rate from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient’s CSBM frequency rate at week 8 was the CSBM rate (CSBMs/week) calculated over that week.
Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|Baseline and Week 8|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population||CSBMs per week||Standard Deviation|Mean
675068|NCT01642914|Secondary|Change From Baseline in CSBM Frequency Rate at Week 4.|"A patient’s CSBM frequency rate from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient’s CSBM frequency rate at week 4 was the CSBM rate (CSBMs/week) calculated over that week.
Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|Baseline and Week 4|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population||CSBMs per week||Standard Deviation|Mean
675069|NCT01642914|Secondary|Change From Baseline in CSBM Frequency Rate at Week 1.|"A patient’s CSBM frequency rate from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient’s CSBM frequency rate at week 1 was the CSBM rate (CSBMs/week) calculated over that week.
Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|Baseline and Week 1|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population||CSBMs per week||Standard Deviation|Mean
675080|NCT01642615|Secondary|Percentage of Participants Who Maintain Healing of EE From Week 8 to Week 24|Percentage of participants who maintain healing of EE from Week 8 to Week 24 among the patients who were healed at Week 8 as assessed by endoscopy.|From Week 8 to Week 24|Participants from the Full Analysis Set, all participants with healed EE at Week 8 who were randomized and received at least one dose of open-label study drug in Weeks 8 to 24.||percentage of participants||95% Confidence Interval|Number
675081|NCT01642615|Secondary|Percentage of Participants With Healing of Erosive Esophagitis (EE) by Week 8|Healing of EE was assessed by endoscopy.|8 weeks|Participants from the Full Analysis Set, all enrolled participants who received at least one dose of open-label study drug in the first 8 weeks, with data available for analysis.||percentage of participants||95% Confidence Interval|Number
675070|NCT01642914|Secondary|Change From Baseline in 12-week CSBM Frequency Rate|"A patient’s 12-week CSBM frequency rate from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient’s 12-week CSBM frequency rate was the CSBM rate (CSBMs/week) calculated over the 12 weeks of the treatment period.
Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|Baseline and 12-week treatment period|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population||CSBMs per week||Standard Deviation|Mean
675071|NCT01642914|Secondary|6/12 Week Abdominal Bloating 30% Responder|A patient was a 6/12 week abdominal bloating 30% responder if, for at least 6 weeks of the 12-week treatment period, that patient’s improvement from baseline in the weekly abdominal bloating score was ≥ 30% from baseline.|12-week treatment period|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population||participants|||Number
675072|NCT01642914|Secondary|Percent Change From Baseline in Abdominal Bloating at Week 12|Abdominal bloating was measured daily using an 11-point Numerical Rating Scale (NRS) where a value of 0 represents no abdominal bloating and a value of 10 represents very severe abdominal bloating. The abdominal bloating score from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). The percent change from baseline at Week 12 in Abdominal Bloating score is the percentage difference between the average nonmissing daily patient assessments of abdominal bloating scores during the 14 day Baseline period, and the average of the nonmissing daily patient assessments of abdominal bloating scores reported during Week 12.|Baseline and Week 12|Reported outcome data is based on the 483 patient Intent-to-Treat Population. The distribution of each of the linaclotide groups was compared, in a pair-wise manner, to the placebo group using the two-sample Kolmogorov–Smirnov test.||percentage change in abdominal bloating||Standard Deviation|Mean
675073|NCT01642914|Secondary|Percent Change From Baseline in 12-week Abdominal Bloating|Abdominal Bloating was measured daily using an 11-point Numerical Rating Scale (NRS) where a value of 0 represents no abdominal bloating and a value of 10 represents very severe abdominal bloating. The abdominal bloating score from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). The percent change from baseline in 12-Week Abdominal Bloating score is the percentage difference between the average nonmissing daily patient assessments score of abdominal bloating scores during the 14 day Baseline period, and the average of the nonmissing daily patient assessments of abdominal bloating scores reported during the 12 week Treatment Period.|Baseline and 12-week treatment period|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population||percentage change of NRS score||Standard Deviation|Mean
675074|NCT01642914|Secondary|Change From Baseline in 12-Week Abdominal Bloating|Abdominal Bloating was measured daily using an 11-point Numerical Rating Scale (NRS) where a value of 0 represents no abdominal bloating and a value of 10 represents very severe abdominal bloating. The abdominal bloating score from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization up to the time of randomization (Visit 3, Day 1). The change from baseline in 12-Week Abdominal Bloating score is the difference between the average nonmissing daily patient assessments of abdominal bloating scores during the 14 day Baseline period, and the average of the nonmissing daily patient assessments of abdominal bloating scores reported during the 12 week Treatment Period.|Baseline and 12-week treatment period|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population||units on a scale||Standard Deviation|Mean
675075|NCT01642914|Secondary|9/12 Week Complete Spontaneous Bowel Movement (CSBM) 3+1 Responder|A 9/12 Week CSBM 3+1 Responder is a patient who is a CSBM 3+1 Weekly Responder for at least 9 out of the 12 weeks of the Treatment Period. A CSBM 3+1 Weekly Responder is a patient who had a CSBM Weekly Frequency Rate that was 3 or greater and increased by 1 or more from baseline.|12-week treatment period|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population||participants|||Number
675076|NCT01642732|Secondary|Difference in Serologic Everolimus and Prostate Biomarker Levels Before and After Treatment With Everolimus|Analysis of pairs of markers will be explored looking for large positive or negative correlations to indicate marker areas for further research.|Prior to treatment and at 14 days|One patient was enrolled and withdrew from the study prior to treatment. The objective was not analyzed.|||||
675077|NCT01642732|Primary|Number of Patients With Adverse Events on Oral Everolimus in Combination With Hormonal Ablation and External Beam Radiation||64 months after beginning everolimus|One patient was enrolled and withdrew from the study prior to treatment. The primary objective was not analyzed.|||||
675121|NCT01642407|Secondary|Number of Participants With Ocular Examination Abnormalities|Ocular examination measures included external examination of the eye, funduscopy, assessments of visual acuity, and color vision. Ocular examination findings were considered abnormal based on investigator’s decision.|Baseline up to Week 16|Safety analysis set included all participants who received at least 1 dose of study drug.||participants|||Number
675082|NCT01642615|Primary|Percent of Participants Who Experience Each Treatment Emergent Adverse Event Experienced by ≥5% of Participants During the 16-week Maintenance Treatment Period|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens on or after Study Day 1, and no more than 30 days after the last dose.|From Week 8 to Week 24|Safety Analysis Set included all participants with healed EE at Week 8 who were randomized and received at least one dose of open-label study drug in Weeks 8 to 24.||percentage of participants|||Number
675083|NCT01642615|Primary|Percentage of Participants Who Experience Each Treatment Emergent Adverse Event Experienced by ≥5% of Participants During the 8-week Healing Treatment Period|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens on or after Study Day 1, and no more than 30 days after the last dose.|8 weeks|Safety analysis set includes all enrolled participants who received at least one dose of open-label study drug in the first 8 weeks.||percentage of participants|||Number
675084|NCT01642602|Secondary|The Percentage of Days With Neither Daytime Nor Nighttime Heartburn Over the 4 Weeks of Treatment|Participants documented the presence or absence and the degree to which daytime and nighttime heartburn symptoms hurt daily in an electronic daily diary.|4 weeks|Full analysis set: All participants who received at least 1 dose of study drug and had post-baseline data (and baseline data if applicable) for the efficacy variable.||Percentage of days||Full Range|Median
675085|NCT01642602|Primary|Percent of Participants Who Experience Each Treatment Emergent Adverse Event Experienced by ≥5% of Participants While Receiving Dexlansoprazole During the 4 Week Treatment Period|A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that started or worsened on or after Study Day 1 (defined as first dose day), and no more than 30 days after the last dose of study drug.|4 weeks|Safety analysis set: All participants who received at least 1 dose of study drug.||Percentage of participants|||Number
675086|NCT01642589|Secondary|Number of Participants Reporting Solicited Injection Site and Systemic Events Following Vaccination With Either Menactra® or Adacel® Vaccine|"Solicited injection site reactions: Pain, Redness, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia.
Grade 3 injection site reactions: Pain - Significant, prevents daily activity; Redness and Swelling - > 100 mm. Grade 3 Systemic reactions: Fever - ≥ 39.0°C; Headache, Malaise, and Myalgia - Significant, prevents daily activity."|Day 0 up to Day 28 post-vaccination|Solicited injection site and systemic events were assessed in all randomized and vaccinated study participants, Safety Analysis Set||Participants|||Number
675087|NCT01642589|Secondary|Geometric Mean Titers of Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Antibody Against Serogroups A, C, Y, and W-135 Before and After Menactra® or Adacel® Vaccination|Functional antibody activity for anti-meningococcal antibody to serogroups A, C, Y, and W-135 were measured using the Serum bactericidal assay using baby rabbit complement (SBA-BR).|Day 0 (pre-vaccination) and 28 days post-vaccination|Geometric mean titers for the anti meningococcal antibody to serogroups A, C, Y, and W 135 were determined in the Full Analysis Set||Titers||95% Confidence Interval|Geometric Mean
675088|NCT01642589|Secondary|Percentage of Participants With Functional Antibody Titers at ≥1:128 Dilution Before and After Menactra® or Adacel® Vaccination.|Functional antibody activity for anti-meningococcal antibody to serogroups A, C, Y, and W-135 were measured using the Serum bactericidal assay using baby rabbit complement (SBA-BR) at ≥ 1:128 dilution.|Day 0 (pre-vaccination) and 28 days post-vaccination|Functional antibody activity for anti meningococcal antibody to serogroups A, C, Y, and W 135 were determined in the Full Analysis Set||Percentage of participants|||Number
675089|NCT01642589|Secondary|Percentage of Participants With Functional Antibody Titers at ≥1:8 Dilution Before and After Menactra® or Adacel® Vaccination|Functional antibody activity for anti-meningococcal antibody to serogroups A, C, Y, and W-135 were measured using the Serum bactericidal assay using baby rabbit complement (SBA-BR) at ≥ 1:8 dilution.|Day 0 (pre-vaccination) and 28 days post-vaccination|Functional antibody activity for anti-meningococcal antibody to serogroups A, C, Y, and W-135 were determined in the Full Analysis Set||Percentage of participants|||Number
675090|NCT01642589|Primary|Percentage of Participants With Seroconversion Following Vaccination With Either Menactra® or Adacel® Vaccine|"Functional antibody activity for anti-meningococcal antibody to serogroups A, C, Y, and W-135 were measured using the Serum bactericidal assay using baby rabbit complement (SBA-BR).
Seroconversion was defined as post-vaccination antibody titers of ≥ 4-fold increase from pre-vaccination level."|28 Days post-vaccination|Functional antibody activity for anti meningococcal antibody to serogroups A, C, Y, and W 135 were determined in the Full Analysis Set||Percentage of participants|||Number
675091|NCT01642485|Secondary|The QTcF Profile of Oral Moxifloxacin (400 mg) in Healthy Japanese Versus Caucasian Subjects||0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4 and 6 hours post-dose|||ms||95% Confidence Interval|Mean
675092|NCT01642485|Secondary|Insulin, Glucose and C-Peptide Effects on the QT/QTc Interval|The effect on QTc was investigated using linear mixed effect models with placebo corrected QTcF (change from average baseline) as a dependent variable and insulin, glucose and C-peptide (placebo corrected) as covariates for the data obtained under the euglycaemic clamp as well as for all data obtained under the clamp and the two types of breakfast.|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4 and 6 hours post-dose|||msec||95% Confidence Interval|Median
675093|NCT01642485|Secondary|Moxifloxacin 400 mg (Single Dose) Compared to Placebo on the Mean QT/QTc Interval.|"Moxifloxacin 400mg Fasted group is reporting the maximum change in QT/QTc interval from placebo treatment."|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4 and 6 hours post-dose|||ms||90% Confidence Interval|Mean
676264|NCT01627561|Secondary|Anti-measles, Mumps and Rubella Antibody Titres in Groups HPV_2D, MMR_DTPa and HPV_2D CO.||On Days 0 and 42||12/2016||||
675094|NCT01642485|Secondary|The Food Effects (Calorie Reduced FDA Breakfast and Carbohydrate Rich Continental Style) on QTcF|"Scott et al (2002) demonstrated an increase in the heart rate of 10bpm in some healthy subjects following ingestion of a carbohydrate meal. There was significant correlation between the resultant hyperinsulinaemia and an increase in skeletal muscle blood flow, and sympathetic activity, with a reduction in vascular resistance.
If postprandial insulinaemia is a significant influence on the QT interval, then carbohydrate rich meals would be expected to show greater effect. Therefore, to explore this on two separate days of the study subjects will be given one of two different types of breakfast:
A high carbohydrate content breakfast, (>70% carbohydrate)
A reduced calorie FDA standard breakfast, (58% fat, low carbohydrate content) to determine effect on QT interval."|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4 and 6 hours post-dose|||ms||90% Confidence Interval|Mean
675095|NCT01642485|Primary|The Effect of Food (Fasted and Fed State) on the Degree of QT Prolongation Caused by Moxifloxacin|The primary baseline corrections were calculated using averaged QTc baseline values (the mean of all median readings recorded for each time-point on the baseline Day -1). This single value (QTcbaselineAV) was used to calculate ΔQTc for each study period.|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4 and 6 hours post-dose|Since the baseline was used as a covariate in the analysis, using the standard deviation of the change from baseline, in the simple sample size formula is justified. Assuming a standard deviation of 7 msec for the single differences, sample sizes for the sum can therefore work with a standard deviation of 6.5 msec.||ms||90% Confidence Interval|Mean
675096|NCT01642407|Other Pre-specified|Change From Baseline in Tricuspid Annular Plane Systolic Excursion (TAPSE) at Week 16|Tricuspid annular plane systolic excursion is a parameter depicting global right ventricular function. Change from baseline in TAPSE (in cm) was reported in this outcome measure.|Baseline, Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time point.||cm||Standard Deviation|Mean
675097|NCT01642407|Other Pre-specified|Number of Participants With Pericardial Effusion|Pericardial effusion is the presence of an abnormal amount of fluid in the pericardial cavity, as determined by echocardiography.|Baseline up to Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug.||participants|||Number
675098|NCT01642407|Other Pre-specified|Change From Baseline in Pulmonary Regurgitation - Pressure Gradient (PR-PG) End-Diastole at Week 16|Pulmonary regurgitation (PR) or insufficiency is a valvular heart disease characterized by an incomplete closure of the pulmonary valve leading to a diastolic reflux into the right ventricle. Change from baseline in PR-PG end-diastole (in mmHg) was reported in this outcome measure.|Baseline, Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time point.||mmHg||Standard Deviation|Mean
675099|NCT01642407|Other Pre-specified|Change From Baseline in Tricuspid Regurgitation - Pressure Gradient (TR-PG) Peak at Week 16|Tricuspid regurgitation (insufficiency) is the failure of the tricuspid valve to close properly during systole, leading to the leaking of blood from the right ventricle into the right atrium. Change from baseline in TR-PG peak (in mmHg) was reported in this outcome measure.|Baseline, Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time point.||mmHg||Standard Deviation|Mean
675100|NCT01642407|Other Pre-specified|Change From Baseline in Tricuspid Valve Annulus Size at Week 16|The tricuspid valve lies between the right atrium and the right ventricle and is placed in a more apical position than the mitral valve. The annulus separates the right atrium from the right ventricle. Change from baseline in tricuspid valve annulus size (in cm) was reported in this outcome measure.|Baseline, Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time points.||cm||Standard Deviation|Mean
675101|NCT01642407|Other Pre-specified|Change From Baseline in Right Ventricular Size at Week 16||Baseline, Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time points.||centimeter (cm)||Standard Deviation|Mean
675102|NCT01642407|Other Pre-specified|Change From Baseline in Right Ventricular Tei Index at Week 16|The right ventricular Tei Index is an index of myocardial performance. It is defined as the sum of isovolumic contraction time and isovolumic relaxation time divided by the ejection time.|Baseline, Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time points.||ratio||Standard Deviation|Mean
675103|NCT01642407|Other Pre-specified|Change From Baseline in Ratio of Acceleration Time to Ejection Time (AcT/ET) at Week 16|Acceleration time and ejection time are quantitative Doppler parameters and ratio of acceleration time to ejection time is a useful tool to evaluate the severity of aortic stenosis.|Baseline, Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time points.||ratio||Standard Deviation|Mean
675104|NCT01642407|Other Pre-specified|Apparent Volume of Distribution (Vz/F) of Sildenafil|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|Pre-dose (0 hour) on Week 4, 8, 16 and 1, 2, 4, 8 hours post-dose on Week 16|PK parameter analysis set included all participants who have at least 1 of PK parameters of interest. Here,'N' signifies those participants who were evaluable for this measure.||liter||Full Range|Median
675105|NCT01642407|Other Pre-specified|Apparent Oral Clearance (CL/F) of Sildenafil|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.|Pre-dose (0 hour) on Week 4, 8, 16 and 1, 2, 4, 8 hours post-dose on Week 16|PK parameter analysis set included all participants who have at least 1 of PK parameters of interest.||liter per hour||Geometric Coefficient of Variation|Geometric Mean
675148|NCT01642238|Primary|Platelet-thrombus Formation in an ex Vivo Model of Thrombosis|Change in thrombus size at 1 hour as compared to Pre-treatment baseline, where a positive change represents a decrease in thrombus size.|Pre-treatment baseline and 1 hour|||percent change||95% Confidence Interval|Mean
676265|NCT01627561|Secondary|Anti-measles, Mumps and Rubella Seropositivity Rates in Groups HPV_2D, MMR_DTPa and HPV_2D CO.||On Days 0 and 42||12/2016||||
675106|NCT01642407|Other Pre-specified|Terminal Half Life (t1/2) of Sildenafil and UK-103,320|Terminal half-life is the time measured for the plasma concentration to decrease by one half of its original concentration. UK-103,320 was a main metabolite of sildenafil and was produced by cytochrome P450 3A4.|Pre-dose (0 hour) on Week 4, 8, 16 and 1, 2, 4, 8 hours post-dose on Week 16|PK parameter analysis set included all participants who have at least 1 of PK parameters of interest. Here, ‘n’ signifies those participants who were evaluable at specified time points.||hour||Full Range|Median
675107|NCT01642407|Other Pre-specified|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Sildenafil and UK-103,320|UK-103,320 was the main metabolite of Sildenafil and was produced by cytochrome P450 3A4.|Pre-dose (0 hour) on Week 4, 8, 16 and 1, 2, 4, 8 hours post-dose on Week 16|PK parameter analysis set included all participants who have at least 1 of PK parameters of interest.||hour||Full Range|Median
675108|NCT01642407|Other Pre-specified|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Sildenafil and UK-103,320|UK-103,320 was the main metabolite of Sildenafil and was produced by cytochrome P450 3A4.|Pre-dose (0 hour) on Week 4, 8, 16 and 1, 2, 4, 8 hours post-dose on Week 16|PK parameter analysis set included all participants who have at least 1 of PK parameters of interest.||nanogram*hour per millimeter||Geometric Coefficient of Variation|Geometric Mean
675109|NCT01642407|Other Pre-specified|Maximum Observed Plasma Concentration (Cmax) of Sildenafil and UK-103,320|UK-103,320 was the main metabolite of Sildenafil and was produced by cytochrome P450 3A4.|Pre-dose (0 hour) on Week 4, 8, 16 and 1, 2, 4, 8 hours post-dose on Week 16|Pharmacokinetic (PK) parameter analysis set included all participants who have at least 1 of PK parameters of interest.||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
675110|NCT01642407|Secondary|Change From Baseline in Arterial Oxygen Saturation (SaO2) at Week 16|SaO2 is the percentage of arterial oxygen (amount of oxygen bound to hemoglobin in arterial blood). Change from baseline in percentage of arterial oxygen was reported in this outcome measure.|Baseline, Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time points.||percentage of arterial oxygen||Standard Deviation|Mean
675111|NCT01642407|Secondary|Change From Baseline in Mixed Venous Oxygen Saturation (SvO2) at Week 16|SvO2 is the percentage of mixed venous oxygen (amount of oxygen bound to hemoglobin in venous blood). Change from baseline in percentage of mixed venous oxygen was reported in this outcome measure.|Baseline, Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time points.||percentage of mixed venous oxygen||Standard Deviation|Mean
675112|NCT01642407|Secondary|Change From Baseline in Systemic Vascular Resistance Index (SVRI) at Week 16|SVRI equals systemic vascular resistance (SVR) times BSA. SVR is the resistance to blood flow through the systemic circulation and it was measured in Wood units. Wood unit =80 dyne*seconds per centimetre^5 (dyne*sec/cm^5).|Baseline, Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time points.||Wood units*meter^2||Standard Deviation|Mean
675113|NCT01642407|Secondary|Change From Baseline in Systemic Vascular Resistance (SVR) at Week 16|The resistance to blood flow through the systemic circulation is known as SVR. This can be used in measuring blood pressure, blood flow and cardiac function and measured in terms of Wood units. Wood unit =80 dyne*seconds per centimetre^5 (dyne*sec/cm^5).|Baseline, Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time points.||Wood units||Standard Deviation|Mean
675114|NCT01642407|Secondary|Change From Baseline in Cardiac Index (CI) at Week 16|Cardiac index is a hemodynamic parameter that relates the cardiac output from left ventricle in one minute to BSA, thus relating heart performance to the size of the individual. CI was calculated as cardiac output in systemic circulation divided by BSA.|Baseline, Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time points.||liter per minute per meter square||Standard Deviation|Mean
675115|NCT01642407|Secondary|Change From Baseline in Cardiac Output (CO) at Week 16|Cardiac output is simply the amount of blood pumped by the heart per minute.|Baseline, Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time points.||liter per minute||Standard Deviation|Mean
675116|NCT01642407|Secondary|Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at Week 16|PCWP was measured by pulmonary artery catheterization and provided an indirect measure of left atrial pressure.|Baseline, Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time points.||mmHg||Standard Deviation|Mean
675117|NCT01642407|Secondary|Change From Baseline in Right Atrial Pressure (RAP) at Week 16|RAP is the blood pressure in the right atrium of the heart. It reflects the amount of blood returning to the heart and the ability of the heart to pump the blood into the arterial system. RAP was measured using a pressure transducer positioned at the mid-axillary line with the participant in the supine position.|Baseline, Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time points.||mmHg||Standard Deviation|Mean
675118|NCT01642407|Secondary|Change From Baseline in Pulmonary Vascular Resistance (PVR) at Week 16|The resistance to blood flow through the pulmonary circulation is known as PVR. It is largely influenced by the caliber of the pulmonary arteries and capillaries and was measured in terms of Wood units. Wood unit =80 dyne*seconds per centimetre^5 (dyne*sec/cm^5).|Baseline, Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time points.||Wood units||Standard Deviation|Mean
675119|NCT01642407|Secondary|Change From Baseline in Systemic Artery Systolic and Diastolic Pressure at Week 16||Baseline, Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time points.||mmHg||Standard Deviation|Mean
675120|NCT01642407|Secondary|Change From Baseline in Pulmonary Artery Systolic and Diastolic Pressure at Week 16||Baseline, Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time points.||mmHg||Standard Deviation|Mean
675122|NCT01642407|Secondary|Number of Participants With Clinically Significant 12-Lead Electrocardiogram (ECG) Abnormalities|Criteria for clinically significant abnormality in ECG parameters: Maximum corrected QT interval (QTc) from 450 millisecond (msec) to less than (<) 480 msec, Maximum QTcB interval (Bazett’s Correction) from 450 msec to <480 msec, Maximum QTcF interval (Fredericia’s Correction) from 450 msec to <480 msec, maximum QTc interval increase from baseline of 30 msec to <60 msec and >=60 msec.|Baseline up to Week 16|Safety analysis set included all participants who received at least 1 dose of study drug.||participants|||Number
675123|NCT01642407|Secondary|Number of Participants With Laboratory Abnormalities|Laboratory abnormality criteria: Hematology (hemoglobin, hematocrit, red blood cell count [less than {<}]0.8*lower limit of normal [LLN]; platelets <0.5*LLN, greater than [>]1.75*upper limit of normal [ULN], white blood cells <0.6*LLN, >1.5*ULN; lymphocytes, neutrophils <0.8*LLN, >1.2*ULN, eosinophils, basophils, monocytes >1.2*ULN); liver function (total and direct bilirubin >1.5*ULN, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase >3.0*ULN, total protein, albumin <0.8*LLN, >1.2*ULN); renal (creatinine, blood urea nitrogen >1.3*ULN); electrolytes (sodium <0.95*LLN, >1.05*ULN, potassium, chloride <0.9*LLN, >1.1*ULN; other (glucose <0.6*LLN or >1.5*ULN ); urinalysis (dipstick) urine glucose, urine protein, urine blood/Hemoglobin, [greater than or equal to {>=}1].|Baseline up to Week 16|Safety analysis set included all participants who received at least 1 dose of study drug.||participants|||Number
675124|NCT01642407|Secondary|Change From Baseline in Heart Rate at Week 4, 8 and 16||Baseline, Week 4, 8, 16|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time points.||beats per minute (bpm)||Standard Deviation|Mean
675125|NCT01642407|Secondary|Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Week 4, 8 and 16|BP measurement is recorded as 1) Systolic blood pressure when heart is contracting and it is the maximum arterial pressure during contraction of left ventricle. 2) Diastolic BP when heart is relaxing and it is the minimum arterial pressure during relaxation and dilation of ventricles.|Baseline, Week 4, 8, 16|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time points.||mmHg||Standard Deviation|Mean
675126|NCT01642407|Secondary|Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to 28 days after last dose of study drug (up to 20 weeks)|Safety analysis set included all participants who received at least 1 dose of study drug.||participants|||Number
675127|NCT01642407|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to 28 days after last dose of study drug (up to 20 weeks)|Safety analysis set included all participants who received at least 1 dose of study drug.||participants|||Number
675128|NCT01642407|Secondary|Change From Baseline in N-terminal Pro Brain Natriuretic Peptide (NT Pro-BNP) at Week 52|NT pro-BNP is a cardiac marker, having the prognostic value for participants with heart failure or left ventricular dysfunction. Higher level of the marker was indicative of heart damage.|Baseline, Week 52||||||
675129|NCT01642407|Secondary|Change From Baseline in Brain Natriuretic Peptide (BNP) at Week 52|BNP is produced by ventricular cardiomyocytes. It causes reduction in preload and blood pressure by vasodilatation.|Baseline, Week 52||||||
675130|NCT01642407|Secondary|Change From Baseline in World Health Organization (WHO) Functional Class in Participants With Pulmonary Arterial Hypertension (PAH) at Week 28, 40 and 52|WHO functional classification for PAH range from Class I (no limitation in physical activity, no dyspnea with normal activity), Class II (slight limitation of physical activity), Class III (marked limitation of physical activity) and Class IV (cannot perform a physical activity without any symptoms, dyspnea at rest). The change from baseline in WHO functional class was classified into “Improved”, “No change” and “Worsened”. Improvement = reduction in functional class, worsened = increase in functional class and no change = no change in functional class.|Baseline, Week 28, 40, 52||||||
675131|NCT01642407|Primary|Change From Baseline in N-terminal Pro Brain Natriuretic Peptide (NT Pro-BNP) at Week 16|NT pro-BNP is a cardiac marker, having the prognostic value for participants with heart failure or left ventricular dysfunction. Higher level of the marker was indicative of heart damage.|Baseline, Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time points.||picogram per milliliter||Standard Deviation|Mean
675132|NCT01642407|Primary|Change From Baseline in Brain Natriuretic Peptide (BNP) at Week 16|BNP is produced by ventricular cardiomyocytes. It causes reduction in preload and blood pressure by vasodilatation.|Baseline, Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time points.||picogram per milliliter||Standard Deviation|Mean
675133|NCT01642407|Primary|Change From Baseline in World Health Organization (WHO) Functional Class in Participants With Pulmonary Arterial Hypertension (PAH) at Week 16|WHO functional classification for PAH range from Class I (no limitation in physical activity, no dyspnea with normal activity), Class II (slight limitation of physical activity), Class III (marked limitation of physical activity) and Class IV (cannot perform a physical activity without any symptoms, dyspnea at rest). The change from baseline in WHO functional class was classified into “Improved”, “No change” and “Worsened”. Improvement = reduction in functional class, worsened = increase in functional class and no change = no change in functional class. Change from baseline in number of participants in each functional class were reported.|Baseline, Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here,'N' signifies those participants who were evaluable for this measure.||participants|||Number
675134|NCT01642407|Primary|Change From Baseline in World Health Organization (WHO) Functional Class in Participants With Pulmonary Arterial Hypertension (PAH) at Week 8|WHO functional classification for PAH range from Class I (no limitation in physical activity, no dyspnea with normal activity), Class II (slight limitation of physical activity), Class III (marked limitation of physical activity) and Class IV (cannot perform a physical activity without any symptoms, dyspnea at rest). The change from baseline in WHO functional class was classified into “Improved”, “No change” and “Worsened”. Improvement = reduction in functional class, worsened = increase in functional class and no change = no change in functional class. Change from baseline in number of participants in each functional class were reported.|Baseline, Week 8|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here,'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.||participants|||Number
675135|NCT01642407|Primary|Change From Baseline in World Health Organization (WHO) Functional Class in Participants With Pulmonary Arterial Hypertension (PAH) at Week 4|WHO functional classification for PAH range from Class I (no limitation in physical activity, no dyspnea with normal activity), Class II (slight limitation of physical activity), Class III (marked limitation of physical activity) and Class IV (cannot perform a physical activity without any symptoms, dyspnea at rest). The change from baseline in WHO functional class was classified into “Improved”, “No change” and “Worsened”. Improvement = reduction in functional class, worsened = increase in functional class and no change = no change in functional class. Change from baseline in number of participants in each functional class were reported.|Baseline, Week 4|Efficacy analysis set included all participants who received at least 1 dose of study drug.||participants|||Number
675136|NCT01642407|Primary|Change From Baseline in Mean Pulmonary Artery Pressure (mPAP) at Week 16|It was a hemodynamic parameter and measured using a pressure transducer positioned at the mid-axillary line with the participant in the supine position.|Baseline, Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time points.||millimeter of mercury (mmHg)||Standard Deviation|Mean
675137|NCT01642407|Primary|Change From Baseline in Pulmonary Vascular Resistance Index (PVRI) at Week 16|PVRI equals pulmonary vascular resistance (PVR) times body surface area (BSA) (PVRI = PVR*BSA). PVR is the resistance to blood flow through the pulmonary circulation and it was measured in Wood units. Wood unit =80 dyne*seconds per centimetre^5 (dyne*sec/cm^5).|Baseline, Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time points.||Wood units*meter^2||Standard Deviation|Mean
675138|NCT01642277|Secondary|Assessment of Pelvic Floor Disease Inventory (PFDI) Questionnaire|"The PFDI comprises 46 items on a 4-point symptom severity scale ranging from 1 = Not at all to 4 = Quite a bit. From these items, 13 separate sub-scales are reported: (1) Obstructive discomfort, (2) Irritation, (3) Stress resulting from urinal distress, (4) A general sub-scale for pelvic organ prolapse distress, (5) An anterior sub-scale for pelvic organ prolapse distress, (6) A posterior sub-scale for pelvic organ prolapse distress, (7) An obstructive sub-scale for colorectal anal distress, (8) Incontinence, (9) Pain, and (10) A rectal prolapse sub-scale for colorectal anal distress. For each of these sub-scales, scores from from 0 to 100 (where higher scores indicate greater symptom severity). There are three additional sub-scales: (11) The urinary distress inventory, (12) The pelvic organ distress inventory, and (13) The colorectal distress inventory. Each of these ranges from 0 to 400 (with higher scores indicating greater symptom severity)."|12 weeks|Participants who received solifenacin were asked to complete the PFDI questionnaire at 12 weeks in order to assess certain bowel, bladder, and pelvic symptoms.||units on a scale||Inter-Quartile Range|Median
675139|NCT01642277|Secondary|Assessment of Overactive Bladder Questionnaire (OABQ)|The Overactive Bladder Questionnaire (OAB-q) was developed to assess symptom bother and the impact of overactive bladder (OAB) on health-related quality of life (HRQL). The instrument comprises 33 items. Response options for the symptom frequency and HRQL items are presented as 6-point Likert scales ranging from 'none of the time' to 'all of the time' for symptom frequency (and 'not at all' to 'a very great deal' for symptom bother). From these 33 items, six sub-scales are assessed separately: (1) OAB symptom severity, (2) Coping with OAB symptoms, (3) Concern for OAB symptoms, (4) Sleep as a function of OAB symptoms, (5) Social functioning as a consequence of OAB symptoms, and (6) Health related quality of life (HRQL) as a function of OAB symptoms. Each sub-scale score ranges from 0 to 100 (where higher scores indicate more severe OAB symptoms and lower scores indicate minimal symptom severity).|End of study (Week 12)|Participants who received solifenacin were asked to complete the OABQ at 12 weeks in order to assess overactive bladder symptoms.||units on a scale||Inter-Quartile Range|Median
675140|NCT01642277|Primary|Bacterial Genomic Sequencing|Participants were classified into Low Biomass, Lactobacillus, Gardnerella, Diverse, and Other urotypes based on the bacterial DNA at baseline.|12 weeks|This was a completer analysis comprising participants who completed 12 weeks of treatment (n = 50).||participants|||Number
675141|NCT01642238|Secondary|Blood Thrombogenicity|Coagulation times, assessed using the ROTEM thromboelastometry|24-hours post-treatment|||seconds||95% Confidence Interval|Mean
675142|NCT01642238|Secondary|Blood Thrombogenicity|Coagulation times, assessed using the ROTEM thromboelastometry|1 hr post-treatment|||seconds||95% Confidence Interval|Mean
675143|NCT01642238|Secondary|Blood Thrombogenicity|Coagulation times, assessed using the ROTEM thromboelastometry|Pre-treatment baseline|||seconds||95% Confidence Interval|Mean
675144|NCT01642238|Secondary|Platelet Reactivity|Platelet reactivity measured by VerifyNowP2Y12 assay measuring percent inhibition|24-hours post-treatment|||percent inhibition||95% Confidence Interval|Mean
675145|NCT01642238|Secondary|Platelet Reactivity|Platelet reactivity measured by VerifyNowP2Y12 assay measuring percent inhibition|1 hr post-treatment|||percent inhibition||95% Confidence Interval|Mean
675146|NCT01642238|Secondary|Platelet Reactivity|Platelet reactivity measured by VerifyNowP2Y12 assay measuring percent inhibition|Pre-treatment baseline|||percent inhibition||95% Confidence Interval|Number
675147|NCT01642238|Primary|Platelet-thrombus Formation in an ex Vivo Model of Thrombosis|Change in thrombus size at 24 hours as compared to Pre-treatment baseline, where a positive change represents a decrease in thrombus size.|Pre-treatment baseline and 24 hrs post treatment|||percent change||95% Confidence Interval|Mean
676266|NCT01627561|Secondary|Anti-HPV-16/18 Antibody Titres Assessed by PBNA in a Sub-cohort in Groups HPV_2D, HPV_2D CO and HPV_3D.||At Day 0 and Months 7, 12, 18, 24 and 36||12/2016||||
675149|NCT01642212|Secondary|Change From Baseline in The Scores of DSQ Question 4 During The Treatment Period|Participants' dysphagia symptoms were evaluated using the 4-item DSQ. The questionnaire was developed by the Sponsor, as an ePRO measure, according to the principles of the Final Guidance for Industry for Patient Reported Outcome Measures (PRO Guidance December 2009). All participants used a diary, and responded to Questions 1 (did you eat solid food) and 2 (did food pass slowly or get stuck). If the participant's answer to Question 2 was 'No', the diary ended for that day. If a participant answered 'Yes', he/she advanced to Questions 3 (did you have to do anything to make the food go down or get relief) and 4 (extent to which the participant experienced pain while swallowing). Question 4 is rated as None, I had no pain (score=0), mild pain (score=1), moderate pain (score=2), severe pain (score=3), or very severe pain (score=4); 4 is the worst pain. Baseline was the DSQ score of the 14-day period before randomization. A negative change from baseline indicates that symptoms decreased.|Baseline, Weeks 8, 12, and 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.||scores on a scale||Standard Error|Least Squares Mean
675150|NCT01642212|Secondary|Change From Baseline in The Scores of DSQ Question 1 During The Treatment Period|Participants' dysphagia symptoms were evaluated using the 4-item DSQ. The questionnaire was developed by the Sponsor, as an ePRO measure, according to the principles of the Final Guidance for Industry for Patient Reported Outcome Measures (PRO Guidance December 2009). All participants used a diary, and responded to Questions 1 (did you eat solid food) and 2 (did food pass slowly or get stuck). If the participant's answer to Question 2 was 'No', the diary ended for that day. If a participant answered 'Yes', he/she advanced to Questions 3 (did you have to do anything to make the food go down or get relief) and 4 (extent to which the participant experienced pain while swallowing). Question 1 is rated as Yes (score=0) or No (score=1); higher values indicate a worse outcome. Baseline was the DSQ score of the 14-day period before randomization. A negative change from baseline indicates that symptoms decreased.|Baseline, Weeks 8, 12, and 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.||scores on a scale||Standard Error|Least Squares Mean
675151|NCT01642212|Secondary|Percent of Days That Participants Reported That They Avoided Solid Food During The Baseline And Treatment Periods|Participants' dysphagia symptoms were evaluated using the 4-item DSQ. The questionnaire was developed by the Sponsor, as an ePRO measure, according to the principles of the Final Guidance for Industry for Patient Reported Outcome Measures (PRO Guidance December 2009). All participants used a diary, and responded to Questions 1 (did you eat solid food) and 2 (did food pass slowly or get stuck). If the participant's answer to Question 2 was 'No', the diary ended for that day. If a participant answered 'Yes', he/she advanced to Questions 3 (did you have to do anything to make the food go down or get relief) and 4 (extent to which the participant experienced pain while swallowing). Values were calculated for all the days that Question 1 was answered from 14 days prior to baseline visit up to the final treatment period evaluation.|From 14 days prior to the baseline visit to the final treatment period evaluation|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.||percentage of days||Inter-Quartile Range|Mean
675152|NCT01642212|Secondary|Percent of Participants Who Were Symptom Responders on The DSQ+Pain Scale at The Final Treatment Period Evaluation|Participants' dysphagia symptoms were evaluated using the 4-item DSQ. The questionnaire was developed by the Sponsor, as an ePRO measure, according to the principles of the Final Guidance for Industry for Patient Reported Outcome Measures (PRO Guidance December 2009). All participants used a diary, and responded to Question 1 (did you eat solid food) and Question 2 (did food pass slowly or get stuck). If the answer to Question 2 was 'No', the diary ended for that day. If a participant answered 'Yes', he/she advanced to Question 3 (did you have to do anything to make the food go down or get relief) and Question 4 (extent to which the participant experienced pain while swallowing).The DSQ+pain response was defined as a >/= 30% and >/= 50% reduction from baseline in the combined score from Questions 2, 3, and 4. The 2-week DSQ+pain score was calculated by adding points from Questions 2, 3, and 4 and then taking the average of the available scores over each 2-week interval.|Week 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.||percent of participants|||Number
675153|NCT01642212|Secondary|Percent of Participants With New Symptoms on The EoE Symptom Survey at The Final Treatment Period Evaluation|This outcome assessed the symptoms of participants who were symptom-free at baseline. The EoE survey assessed the following symptoms: heartburn, chest pain, regurgitation, abdominal pain, nausea, and vomiting. Participants indicated, by checking a box, if they had a change in symptoms (excluding dysphasia or food impaction) within the past 2 weeks. Baseline was defined as the assessment before randomization. Responses were as follows regarding symptoms at the final treatment evaluation: No change - participant reported or did not report a specific symptom at both baseline and the final treatment evaluation; Worsened -participant did not report any symptom at baseline, but changed to report at least 1 symptom at the final treatment evaluation.|Week 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.||percent of participants|||Number
675179|NCT01642147|Primary|Mean Blood Flow Velocity in Middle Cerebral Artery||30min after extubation|The number of participants for analysis was determined by sample estimation equation of cohort study. In the equation, the hyperemia frequency from literature and pre-study was used.||cm/s||Standard Deviation|Mean
675180|NCT01642147|Primary|Mean Blood Flow Velocity in Middle Cerebral Artery||after surgery at extubation (average surgery duration: craniotomy group 214min, abdominal group 207min)|The number of participants for analysis was determined by sample estimation equation of cohort study. In the equation, the hyperemia frequency from literature and pre-study was used.||cm/s||Standard Deviation|Mean
675154|NCT01642212|Secondary|Percent of Participants Without Symptoms on The EoE Symptom Survey at The Final Treatment Period Evaluation|This outcome assessed the symptoms of participants who were symptom-free at baseline. The EoE survey assessed the following symptoms: heartburn, chest pain, regurgitation, abdominal pain, nausea, and vomiting. Participants indicated, by checking a box, if they had a change in symptoms (excluding dysphasia or food impaction) within the past 2 weeks. Baseline was defined as the assessment before randomization. Responses were as follows regarding symptoms at the final treatment evaluation: No change - participant did not report a specific symptom at both baseline and the final treatment evaluation; Worsened -participant did not report any symptom at baseline, but changed to report at least 1 symptom at the final treatment evaluation.|Week 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.||percent of participants|||Number
675155|NCT01642212|Secondary|Percent of Participants With Worsened Symptoms on The EoE Symptom Survey at The Final Treatment Period Evaluation|The EoE survey assessed the following symptoms: heartburn, chest pain, regurgitation, abdominal pain, nausea, and vomiting. Participants indicated, by checking a box, if they had a change in symptoms (excluding dysphasia or food impaction) within the past 2 weeks. Baseline was defined as the assessment before randomization. Responses were as follows regarding symptoms at the final treatment evaluation: Improved - participant reported a specific symptom at baseline, but changed to no specific symptom (‘Yes’ to ‘No’); No change - participant reported or did not report a specific symptom at both baseline and the final treatment evaluation; Worsened -participant did not report a specific symptom at baseline, but changed to report that specific symptom (‘No’ to ‘Yes’).|Week 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.||percent of participants|||Number
675156|NCT01642212|Secondary|Percent of Participants With No Change in Symptoms on The EoE Symptom Survey at The Final Treatment Period Evaluation|The EoE survey assessed the following symptoms: heartburn, chest pain, regurgitation, abdominal pain, nausea, and vomiting. Participants indicated, by checking a box, if they had a change in symptoms (excluding dysphasia or food impaction) within the past 2 weeks. Baseline was defined as the assessment before randomization. Responses were as follows regarding symptoms at the final treatment evaluation: Improved - participant reported a specific symptom at baseline, but changed to no specific symptom (‘Yes’ to ‘No’); No change - participant reported or did not report a specific symptom at both baseline and the final treatment evaluation; Worsened -participant did not report a specific symptom at baseline, but changed to report that specific symptom (‘No’ to ‘Yes’).|Week 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.||percent of participants|||Number
675157|NCT01642212|Secondary|Percent of Participants With Improved Symptoms on The Eosinophilic Esophagitis (EoE) Symptom Survey at The Final Treatment Period Evaluation|The EoE survey assessed the following symptoms: heartburn, chest pain, regurgitation, abdominal pain, nausea, and vomiting. Participants indicated, by checking a box, if they had a change in symptoms (excluding dysphasia or food impaction) within the past 2 weeks. Baseline was defined as the assessment before randomization. Responses were as follows regarding symptoms at the final treatment evaluation: Improved - participant reported a specific symptom at baseline, but changed to no specific symptom (‘Yes’ to ‘No’); No change - participant reported or did not report a specific symptom at both baseline and the final treatment evaluation; Worsened -participant did not report a specific symptom at baseline, but changed to report that specific symptom (‘No’ to ‘Yes’).|Week 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.||percent of participants|||Number
675158|NCT01642212|Secondary|Distribution of Responses For The Patient Global Impression of Change (PGIC) Survey at The Final Treatment Evaluation|Participants evaluated the change in their dysphasia (food passing slowly/difficulty swallowing) since the start of the study (screening) by choosing 1 of 7 responses on the PGIC survey: much worse (-3), worse (-2), a little worse (-1), no change (0), a little better (1), better (2), or much better (3). The values reported are the percent of participants who chose that response.|Week 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.||percent of participants|||Number
675159|NCT01642212|Secondary|Change From Baseline in The Physician’s Global Assessment (PGA) of Disease Activity at The Final Treatment Period Evaluation|The physician Investigator (or qualified physician’s assistant or nurse practitioner) completed the PGA to provide the global assessment of eosinophilic esophagitis (EoE) disease activity using a 0 to 100 mm visual analog scale (VAS) scale. The VAS is a 100 mm horizontal line on which the right extreme (100) is labeled “worst possible disease activity” and the left extreme (0) is labeled “no disease activity”. The PGA raters were instructed to consider the line for the VAS a continuum with their own medical opinion or judgment of extremes on either end and to draw a vertical line at a point that best approximates the participant's current level of EoE disease activity. A negative change from baseline indicates that disease activity decreased.|Baseline, Week 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.||scores on a scale||Standard Error|Least Squares Mean
675181|NCT01642147|Primary|Mean Blood Flow Velocity in Middle Cerebral Artery|It was the baseline mean blood flow velocity in middle cerebral artery.|before general anesthesia|The number of participants for analysis was determined by sample estimation equation of cohort study. In the equation, the hyperemia frequency from literature and pre-study was used.||cm/s||Standard Deviation|Mean
675160|NCT01642212|Secondary|Change From Baseline in The Peak Eosinophil Count at Each Available Esophageal Level at The Final Treatment Period Evaluation|An independent, central pathologist determined the peak eosinophil count from the proximal, mid-, and distal levels and selected the maximum peak value across all available esophagus levels. Histopathology data were collected in a blinded fashion. Baseline was defined as the score at screening. A negative change from baseline indicates that eosinophil count decreased.|Baseline, Week 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.||eosinophils/HPF||Standard Error|Least Squares Mean
675161|NCT01642212|Secondary|Change From Baseline in The Total Endoscopy Score at The Final Treatment Period Evaluation|The gross endoscopic appearance of the esophageal surface was evaluated by a blinded study center physician. Endoscopic findings with separate evaluations of the proximal and distal esophagus were recorded with respect to 5 major categories, including exudates or plaques, fixed esophageal rings, edema, furrows, and strictures. The endoscopy score was the sum of the scores for the 5 major categories – grade 0-1 for strictures; grade 0-2 for exudates or plaques, edema, and furrows; and grade 0-3 for fixed esophageal rings for the proximal and distal locations. The maximum endoscopy score was 10 points for each location (proximal and distal), and the total endoscopy score was the sum of the scores for the proximal and distal locations (maximum total score of 20 points). Baseline was defined as the endoscopy score at screening. A negative change from baseline indicates that appearance improved.|Baseline, Week 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.||scores on a scale||Standard Error|Least Squares Mean
675162|NCT01642212|Secondary|Change From Baseline in The Histopathologic Epithelial Features Combined Total Score at The Final Treatment Period Evaluation|Each esophageal biopsy specimen was evaluated microscopically by an independent, central pathologist for signs of epithelial inflammation and lamina propria fibrosis. Histopathologic epithelial features of each available esophageal level biopsy consisting of basal layer hyperplasia, eosinophil peak, dilated intercellular spaces, eosinophil microabcesses, surface layering, surface alteration, and apoptotic epithelial cells were scored and summed. Histopathology data were collected in a blinded fashion. Histopathology epithelial features were scored for both grade and stage. Each feature had a possible score of 0-3 for grade as well as stage. Thus each of the 3 levels had a possible score of 21, and a possible total grade or stage score of 63 for a maximum combined score of 126. The grade and stage score of the lamina propria was not included because the biopsy material was not available. A negative change from baseline indicates that epithelial inflammation decreased.|Baseline, Week 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.||scores on a scale||Standard Error|Least Squares Mean
675163|NCT01642212|Secondary|Percent of Participants Who Were Overall Responders at The Final Treatment Period Evaluation|Overall response was defined as a reduction in the 2-week DSQ score of >/= 30% and >/= 50% from baseline to the final treatment period evaluation and a peak eosinophil count of </= 6/high power field (light microscopy) (HPF) across all available esophageal levels at the final treatment period evaluation. An independent, central pathologist determined the peak eosinophil count from the proximal, mid-, and distal levels and selected the maximum peak value. Histopathology data were collected in a blinded fashion.|Week 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.||percent of participants|||Number
675164|NCT01642212|Secondary|Percent of Participants With a >/= 30% And >/= 50% Reduction In The DSQ Score From Baseline to The Final Treatment Period Evaluation|Participants' dysphagia symptoms were evaluated using the 4-item DSQ. The questionnaire was developed by the Sponsor, as an ePRO measure, according to the principles of the Final Guidance for Industry for Patient Reported Outcome Measures (PRO Guidance December 2009). All participants used a diary, and responded to Questions 1 (did you eat solid food) and 2 (did food pass slowly or get stuck). If the participant's answer to Question 2 was 'No', the diary ended for that day. If a participant answered 'Yes', he/she advanced to Questions 3 (did you have to do anything to make the food go down or get relief) and 4 (extent to which the participant experienced pain while swallowing).The DSQ score was calculated based on responses to Questions 2 and 3 [14 x (sum of points from Questions 2 and 3 in the daily DSQ)/number of diaries with non-missing data]. Baseline was the DSQ score of the 14-day period before randomization.|Baseline, Week 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.||percent of participants|||Number
675165|NCT01642212|Secondary|Percent of Participants With a Peak Eosinophil Count </= 15/High Power Field (Light Microscopy) (HPF) And </= 1/HPF at The Final Treatment Period Evaluation|An independent, central pathologist determined the peak eosinophil count from the proximal, mid-, and distal levels and selected the maximum peak value across all available esophagus levels. Histopathology data were collected in a blinded fashion. The values reported are for participants with histologic response.|Week 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.||percent of participants|||Number
675182|NCT01642082|Secondary|Adverse Events (Primary Serious and All Other AEs)|The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.|Every cycle of study treatment and after treatment for a maximum of 5 years from study entry||||||
676267|NCT01627561|Secondary|Anti-HPV-16/18 Seroconversion Rates Assessed by PBNA in a Sub-cohort in Groups HPV_2D, HPV_2D CO and HPV_3D.||At Day 0 and Months 7, 12, 18, 24 and 36||12/2016||||
675166|NCT01642212|Secondary|Change From Baseline in The DSQ Score For The 50th Percentile of Participants at The Final Treatment Period Evaluation|A cumulative distribution function curve was constructed to illustrate the cumulative proportion of participants (x-axis) vs. the change in the DSQ score from baseline to the final treatment evaluation (y-axis). The 50th percentile is participants with a DSQ score that is in the middle of the distribution of all scores. A negative change from baseline indicates that symptoms decreased.|Baseline, Week 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.||scores on a scale|||Number
675167|NCT01642212|Secondary|Change From Baseline in The DSQ Score Over Time|Participants' dysphagia symptoms were evaluated using the 4-item DSQ. The questionnaire was developed by the Sponsor, as an ePRO measure, according to the principles of the Final Guidance for Industry for Patient Reported Outcome Measures (PRO Guidance December 2009). All participants used a diary, and responded to Questions 1 (did you eat solid food) and 2 (did food pass slowly or get stuck). If the participant's answer to Question 2 was 'No', the diary ended for that day. If a participant answered 'Yes', he/she advanced to Questions 3 (did you have to do anything to make the food go down or get relief) and 4 (extent to which the participant experienced pain while swallowing).The DSQ score was calculated based on responses to Questions 2 and 3 [14 x (sum of points from Questions 2 and 3 in the daily DSQ)/number of diaries with non-missing data]. Baseline was the DSQ score of the 14-day period before randomization. A negative change from baseline indicates that symptoms decreased.|Baseline, Weeks 8 and 12|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.||scores on a scale||Standard Error|Least Squares Mean
675168|NCT01642212|Primary|Change From Baseline in The Dysphagia Symptom Questionnaire (DSQ) Score at The Final Treatment Period Evaluation|Participants' dysphagia symptoms were evaluated using the 4-item DSQ. The questionnaire was developed by the Sponsor, as an ePRO measure, according to the principles of the Final Guidance for Industry for Patient Reported Outcome Measures (PRO Guidance December 2009). All participants used a diary, and responded to Questions 1 (did you eat solid food) and 2 (did food pass slowly or get stuck). If the participant's answer to Question 2 was 'No', the diary ended for that day. If a participant answered 'Yes', he/she advanced to Questions 3 (did you have to do anything to make the food go down or get relief) and 4 (extent to which the participant experienced pain while swallowing).The DSQ score was calculated based on responses to Questions 2 and 3 [14 x (sum of points from Questions 2 and 3 in the daily DSQ)/number of diaries with non-missing data]. Baseline was the DSQ score of the 14-day period before randomization. A negative change from baseline indicates that symptoms decreased.|Baseline, Week 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.||scores on a scale||Standard Error|Least Squares Mean
675169|NCT01642212|Primary|Percent of Participants Who Were Histologic Responders|Histologic response was defined as a peak eosinophil count </= 6/high power field (light microscopy) (HPF) across all esophageal levels at the final treatment evaluation (Week 16). An independent, central pathologist determined the peak eosinophil count from the proximal, mid-, and distal levels and selected the maximum peak value. Histopathology data were collected in a blinded fashion.|Week 16|The modified Intent-to-Treat (MITT) Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.||percent of participants|||Number
675170|NCT01642147|Primary|Oxygen Saturation of Jugular Venous Bulb||120min after extubation|The number of participants for analysis was determined by sample estimation equation of cohort study. In the equation, the hyperemia frequency from literature and pre-study was used.||percentage of oxygen saturation||Standard Deviation|Mean
675171|NCT01642147|Primary|Oxygen Saturation of Jugular Venous Bulb||90min after extubation|The number of participants for analysis was determined by sample estimation equation of cohort study. In the equation, the hyperemia frequency from literature and pre-study was used.||percentage of oxygen saturation||Standard Deviation|Mean
675172|NCT01642147|Primary|Oxygen Saturation of Jugular Venous Bulb||60min after extubation|The number of participants for analysis was determined by sample estimation equation of cohort study. In the equation, the hyperemia frequency from literature and pre-study was used.||percentage of oxygen saturation||Standard Deviation|Mean
675173|NCT01642147|Primary|Oxygen Saturation of Jugular Venous Bulb||30min after extubation|The number of participants for analysis was determined by sample estimation equation of cohort study. In the equation, the hyperemia frequency from literature and pre-study was used.||percentage of oxygen saturation||Standard Deviation|Mean
675174|NCT01642147|Primary|Oxygen Saturation of Jugular Venous Bulb||at extubation|The number of participants for analysis was determined by sample estimation equation of cohort study. In the equation, the hyperemia frequency from literature and pre-study was used.||percentage of oxygen saturation||Standard Deviation|Mean
675175|NCT01642147|Primary|Oxygen Saturation of Jugular Venous Bulb||before general anesthesia|The number of participants for analysis was determined by sample estimation equation of cohort study. In the equation, the hyperemia frequency from literature and pre-study was used.||percentage of oxygen saturation||Standard Deviation|Mean
675176|NCT01642147|Primary|Mean Blood Flow Velocity in Middle Cerebral Artery||120min after extubation|The number of participants for analysis was determined by sample estimation equation of cohort study. In the equation, the hyperemia frequency from literature and pre-study was used.||cm/s||Standard Deviation|Mean
675177|NCT01642147|Primary|Mean Blood Flow Velocity in Middle Cerebral Artery||90min after extubation|The number of participants for analysis was determined by sample estimation equation of cohort study. In the equation, the hyperemia frequency from literature and pre-study was used.||cm/s||Standard Deviation|Mean
675178|NCT01642147|Primary|Mean Blood Flow Velocity in Middle Cerebral Artery||60min after extubation|The number of participants for analysis was determined by sample estimation equation of cohort study. In the equation, the hyperemia frequency from literature and pre-study was used.||cm/s||Standard Deviation|Mean
675184|NCT01642082|Secondary|Duration of Progression-free Survival|Progression-free survival is defined as the duration alive from study entry until progression is documented or death, whichever comes sooner. Progressive disease is defined as at least a 5 mm absolute increase and a 20% relative increase in the sum of measurable target lesions’ longest dimensions relative to the smallest sum at baseline or on study or the appearance of new lesions or unequivocal progression of existing non-target lesions.|CT scan or MRI were to assess progression every other cycle for the first 6 months; every three months thereafter; and any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.|All eligible and treated patients.||months||90% Confidence Interval|Median
675185|NCT01642082|Secondary|Progression-free Survival at 6 Months|"Progression-free survival is defined as the duration alive from study entry until progression is documented or death, whichever comes sooner. Progressive disease is defined as at least a 5 mm absolute increase and a 20% relative increase in the sum of measurable target lesions’ longest dimensions relative to the smallest sum at baseline or on study or the appearance of new lesions or unequivocal progression of existing non-target lesions.
Disease progression within 6 months of study entry or death within 6 months of study entry and prior to disease progression counts as an event for progression-free survival at 6 months."|: CT scan or MRI were to assess progression every other cycle for the first 6 months; every three months thereafter; and any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.|All eligible and treated patients||percentage of participants||90% Confidence Interval|Number
675186|NCT01642082|Primary|Treatment and Progression-free Survival at 6 Months|"Treatment and Progression-free Survival is defined as the duration alive from study entry until progression is documented, death or non-protocol treatment is initiated; whichever comes sooner. Progressive disease is defined as at least a 5 mm absolute increase and a 20% relative increase in the sum of measurable target lesions’ longest dimensions relative to the smallest sum at baseline or on study or the appearance of new lesions or unequivocal progression of existing non-target lesions.
Non-protocol treatment initiation prior to disease progression and prior to 6 months from study entry was counted as an event for treatment and progression-free survival at 6 months. Disease progression within 6 months of study entry or death within 6 months of study entry and prior to disease progression counts as an event for treatment and progression-free survival at 6 months."|CT scan or MRI were to assess progression every other cycle for the first 6 months; every three months thereafter; and any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease|All eligible and treated patients||percentage of participants||90% Confidence Interval|Number
675187|NCT01642082|Primary|Response|Response was defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) and based on imaging done every other cycle. Responses can be either partial or complete. Per RECIST v1.1 target and non-target lesions are assessed by MRI or CT scan: Complete Response (CR), Disappearance of all target and non-target lesions and all lymph nodes must be < 10 mm in short axis; Partial Response (PR), >=30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD.|Scans to assess response were done every other cycle for the first 6 months; every three months thereafter; and any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease. Responses must be confirmed.|All eligible and treated patients||percentage of participants||90% Confidence Interval|Number
675188|NCT01642004|Primary|Number of Deaths From Any Cause in All Randomized Participants at Primary Endpoint|The number of participants who died from any cause was reported for each arm. Interim analysis (Primary Endpoint) was planned to occur after at least 196 deaths, with the actual analysis occurring at 199 deaths.|Randomization until 199 deaths, up to November 2014, approximately 25 months|All randomized participants||participants|||Number
675189|NCT01642004|Secondary|Progression Free Survival (PFS) Time in Months by Baseline PD-L1 Expression for All Randomized Participants at Primary Endpoint|PFS time was measured for all randomized participants grouped by their baseline PD-L1 expression levels. PFS was defined as the time from the date of randomization to the date of the first documented tumor progression as determined by the investigator per RECIST v1.1 criteria, or death due to any cause. The PFS curves were estimated using KM method. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who started subsequent anti-cancer therapy (including on-treatment palliative radiotherapy of non-target bone lesions or CNS lesions) without a prior reported progression were censored at the last evaluable tumor assessment prior to subsequent anti-cancer therapy. Interim analysis (Primary Endpoint) was planned to occur after at least 196 deaths, with the actual analysis occurring at 199 deaths.|Randomization until 199 deaths, up to November 2014, approximately 25 months|All randomized participants||months||95% Confidence Interval|Median
675190|NCT01642004|Secondary|Objective Response Rate (ORR) by Baseline PD-L1 Expression for All Randomized Participants at Primary Endpoint|ORR was reported for all randomized participants grouped by their baseline PD-L1 expression level. ORR was defined as the percentage of all randomized participants whose Best Overall Response (BOR) was a confirmed Complete Response (CR) or Partial Response (PR). PD-L1 expression in participants was defined as the percent of disease tumor cells demonstrating plasma membrane PD-L1 staining of any intensity using an immunohistochemistry (IHC) assay. CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters. CIs were computed using the Clopper and Pearson method.|Randomization until 199 deaths, up to November 2014, approximately 25 months|All randomized participants||percentage of participants||95% Confidence Interval|Number
675191|NCT01642004|Secondary|Overall Survival (OS) Time in Months by Baseline PD-L1 Expression for All Randomized Participants at Primary Endpoint|OS was measured in months for all randomized participants grouped by their baseline PD-L1 expression level. PD-L1 expression was defined as the percent of disease tumor cells demonstrating plasma membrane PD-L1 staining of any intensity using an immunohistochemistry (IHC) assay. OS was defined as the time between the date of randomization and the date of death from any cause. Participants were censored at the date they were last known to be alive. Median OS time was calculated using Kaplan-Meier (KM) method. Interim analysis (Primary Endpoint) was planned to occur after at least 196 deaths, with the actual analysis occurring at 199 deaths.|Randomization until 199 deaths, up to November 2014, approximately 25 months|All randomized participants||months||95% Confidence Interval|Median
676268|NCT01627561|Secondary|Anti-HPV-16/18 Antibody Titres Assessed by PBNA in a Sub-cohort in Group MMR_DTPa||At Day 0, Month 7 and Month 12||12/2016||||
675192|NCT01642004|Secondary|Percentage of Participants Experiencing Disease-related Symptom Improvement by Week 12|Disease-related symptom improvement rate by Week 12 was defined as the percentage of randomized participants who had a 10 point or greater decrease from baseline in average symptom burden index score at any time between randomization and Week 12. The participant portion of the Lung Cancer Symptom Scale (LCSS) consisted of 6 symptom-specific questions that addressed cough, dyspnea, fatigue, pain, hemoptysis, and anorexia, plus 3 summary items on symptom distress, interference with activity level, and global health-related Quality of Life (QoL). The scores range from 0 to 100, with 0 representing the best possible score and 100 being the worst possible score. The average symptom burden index score at each assessment was defined as the mean of the 6 symptom-specific questions of the LCSS. 95% CIs were computed using Clopper-Pearson Method.|Randomization to Week 12|All randomized participants||percentage of participants||95% Confidence Interval|Number
675193|NCT01642004|Secondary|Progression-Free Survival (PFS) Time in Months for All Randomized Participants at Primary Endpoint|PFS was defined as the time from the date of randomization to the date of the first documented tumor progression as determined by the investigator per RECIST v1.1 criteria, or death due to any cause. Participants underwent radiographic tumor assessments every 6 weeks (+/- 5 days) from week 9 (+/- 5 days) for the first year on treatment, then every 12 weeks after the first year on treatment until documented disease progression. The PFS curves were estimated using KM method. Two-sided 95% CI for median PFS were computed by Brookmeyer and Crowley method (using log-log transformation). Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who started any subsequent anti-cancer therapy (including on-treatment palliative RT of non-target bone lesions or CNS lesions) without a prior reported progression were to be censored at the last evaluable tumor assessment prior to or on initiation of the subsequent anti-cancer therapy.|Randomization until 199 deaths, up to November 2014, approximately 25 months|All randomized participants (105 PFS events in Nivolumab arm; 122 PFS events in Docetaxel arm)||months||95% Confidence Interval|Median
675194|NCT01642004|Secondary|Progression-Free Survival (PFS) at Primary Endpoint|PFS rate was defined as the probability that participants will experience no disease progression or death from any cause at a given time point following randomization. Progression was assessed by investigators according to RECIST v1.1. 95% CIs were estimated using the Kaplan-Meier method. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who started any subsequent anti-cancer therapy (including on-treatment palliative radiation therapy (RT) of non-target bone lesions or CNS lesions) without a prior reported progression were to be censored at the last evaluable tumor assessment prior to or on initiation of the subsequent anti-cancer therapy|Randomization to 12 months post-randomization, up to November 2014|All randomized participants (105 PFS events in Nivolumab arm; 122 PFS events in Docetaxel arm)||percent probability of PFS||95% Confidence Interval|Number
675195|NCT01642004|Secondary|Duration of Objective Response (DOR) in Months for All Confirmed Responders at Primary Endpoint|"DOR was defined as the time from the date of first confirmed response to the date of the first documented tumor progression (per RECIST v1.1), as determined by the investigator, or death due to any cause, whichever occurred first. DOR was evaluated only for confirmed responders (i.e. participants with confirmed CR or PR).
CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters.
Participants who neither progressed nor died were censored on the date of their last evaluable tumor assessment."|Date of confirmed response to date of documented tumor progression, up to November 2014, approximately 25 months|All confirmed responders (participants demonstrating CR or PR)||months||95% Confidence Interval|Median
675196|NCT01642004|Secondary|Time To Response (TTR) in Months for All Confirmed Responders at Primary Endpoint|Time to Response (TTR) for participants demonstrating a response (either CR or PR) was defined as the time from the date of randomization to the date of the first confirmed response. CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters.|Randomization until confirmed response, up to November 2014, approximately 25 months|All confirmed responders (participants demonstrating CR or PR)||months||Full Range|Median
675197|NCT01642004|Primary|Overall Survival (OS) Rate in All Randomized Participants|The overall survival rate is the probability that a participant will be alive at 6, 12, and 18 months following randomization. Overall survival was defined as the time between the date of randomization and the date of death as a result of any cause. Survival rates were determined via Kaplan-Meier estimates.|Randomization to 18 months post-randomization, up to June 2015|All randomized participants||percent probability of OS||95% Confidence Interval|Number
675198|NCT01642004|Primary|Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint|OS was defined as the time between the date of randomization and the date of death from any cause. Participants were censored at the date they were last known to be alive. Median OS time was calculated using Kaplan-Meier (KM) method. Hazard ratio (HR) and the corresponding Confidence Interval (CI) were estimated in a stratified Cox proportional hazards model for distribution of OS in each randomized arm. Interim analysis (Primary Endpoint) was planned to occur after at least 196 deaths, with the actual analysis occurring at 199 deaths.|Randomization until 199 deaths, up to November 2014, approximately 25 months|All randomized participants||months||95% Confidence Interval|Median
675199|NCT01642004|Secondary|Objective Response Rate (ORR) in All Randomized Participants at Primary Endpoint|"ORR was defined as the percentage of all randomized participants whose Best Overall Response (BOR) was a confirmed Complete Response (CR) or Partial Response (PR). BOR was defined as the best investigator-assessed response designation, recorded between the date of randomization and the date of objectively documented progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) or the date of subsequent anti-cancer therapy (excluding on-treatment palliative radiotherapy of non-target bone lesions or Central Nervous System (CNS) lesions), whichever occurred first.
CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters. CIs were computed using the Clopper and Pearson method."|Randomization until 199 deaths, up to November 2014, approximately 25 months|All randomized participants||percentage of participants||95% Confidence Interval|Number
675200|NCT01642004|Other Pre-specified|Overall Survival (OS) Time in Months for All Randomized Participants at Updated Survival Follow-up|OS was defined as the time between the date of randomization and the date of death from any cause. Participants were censored at the date they were last known to be alive. Median OS time was calculated using Kaplan-Meier (KM) method. Hazard ratio (HR) and the corresponding Confidence Interval (CI) were estimated in a stratified Cox proportional hazards model for distribution of OS in each randomized arm. Survival follow-up analysis occurred 7.4 months after Primary Endpoint was reached, representing a minimum OS follow-up time of 18.0 months.|Randomization until July 2015, approximately 33 months|All randomized participants||months||95% Confidence Interval|Median
675201|NCT01641991|Secondary|TNA NF50 Peak Geometric Mean Titer (GMT) Antibody Response Through Day 100|Blood was collected from all participants prior to vaccination and at scheduled follow up visits weekly through Day 70, at Day 84 and at Day 100 for testing in the toxin neutralization antibody assay to determine the NF50 antibody titer. To determine the group peak GMT, the highest titer assessed for each subject at any post vaccination visit through Day 100 was determined. The geometric mean of each subjects' peak titers was calculated along with the 95% confidence intervals.|Day 7 through Day 100|The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all doses in the primary series, completed all scheduled visits up to and including the Day 100 visit in-window, and who contributed both pre- and post-vaccination blood samples for testing for which valid results were reported.||titer||95% Confidence Interval|Geometric Mean
675202|NCT01641991|Secondary|Number of Subjects With a Four-fold or Greater Increase From Baseline in Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Against the Protective Antigen (Anti-PA IgG)|Blood was collected from all participants prior to vaccination and at scheduled follow up visits weekly through Day 70, at Day 84 and at Day 100 for testing in the ELISA assay to determine the anti-PA IgG antibody concentration. A participant met the threshold of a 4-fold rise in anti-PA IgG antibody concentration if the post vaccination concentration was an increase by 4-fold or more from the baseline (Day 0) concentration.|Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100.|The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all doses in the primary series, completed all scheduled visits up to and including the Day 100 visit in-window, and who contributed both pre- and post-vaccination blood samples for testing for which valid results were reported.||participants|||Number
675203|NCT01641991|Secondary|Number of Participants Reporting Fever in the Eight Days After the 6-month Boost Vaccination by Maximum Severity|Participants were given a thermometer with a memory aid to record their oral temperature at least once daily, encouraged to be at the same time each day, but at any time the participant felt they may have a fever. The highest temperature assessed for each day was reported and graded according to the protocol grading scale of severe being greater than or equal to 39 degrees Celsius, moderate 38.5-38.9 degrees Celsius, and mild 38.0-38.4 degrees Celsius. Participants are counted by the maximum severity they reported experiencing fever on any of the 8 days.|Day 0-7 after vaccination at Month 6|The analysis population includes all participants who received the 6-month boost vaccination and recorded oral temperatures.||participants|||Number
675204|NCT01641991|Secondary|Number of Participants Reporting Fever in the Eight Days After Vaccination at Day 28 by Maximum Severity|Participants were given a thermometer with a memory aid to record their oral temperature at least once daily, encouraged to be at the same time each day, but at any time the participant felt they may have a fever. The highest temperature assessed for each day was reported and graded according to the protocol grading scale of severe being greater than or equal to 39 degrees Celsius, moderate 38.5-38.9 degrees Celsius, and mild 38.0-38.4 degrees Celsius. Participants are counted by the maximum severity they reported experiencing fever on any of the 8 days.|Day 0-7 after vaccination at Day 28|The analysis population includes all participants who were vaccinated at Day 28 per protocol, excluding 59 participants at one clinic site who were vaccinated in the fatty tissue over the triceps rather than the intended inferior deltoid.||participants|||Number
675205|NCT01641991|Secondary|Number of Participants Reporting Fever in the Eight Days After Vaccination at Day 14 by Maximum Severity|Participants were given a thermometer with a memory aid to record their oral temperature at least once daily, encouraged to be at the same time each day, but at any time the participant felt they may have a fever. The highest temperature assessed for each day was reported and graded according to the protocol grading scale of severe being greater than or equal to 39 degrees Celsius, moderate 38.5-38.9 degrees Celsius, and mild 38.0-38.4 degrees Celsius. Participants are counted by the maximum severity they reported experiencing fever on any of the 8 days.|Day 0-7 after vaccination at Day 14|The analysis population includes all participants who were vaccinated at Day 14 per protocol, excluding 59 participants at one clinic site who were vaccinated in the fatty tissue over the triceps rather than the intended inferior deltoid.||participants|||Number
675206|NCT01641991|Secondary|Number of Participants Reporting Fever in the Eight Days After Vaccination at Day 0 by Maximum Severity|Participants were given a thermometer with a memory aid to record their oral temperature at least once daily, encouraged to be at the same time each day, but at any time the participant felt they may have a fever. The highest temperature assessed for each day was reported and graded according to the protocol grading scale of severe being greater than or equal to 39 degrees Celsius, moderate 38.5-38.9 degrees Celsius, and mild 38.0-38.4 degrees Celsius. Participants are counted by the maximum severity they reported experiencing fever on any of the 8 days.|Day 0-7 after vaccination at Day 0|The analysis population includes all participants who were vaccinated at Day 0 per protocol, excluding 59 participants at one clinic site who were vaccinated in the fatty tissue over the triceps rather than the intended inferior deltoid.||participants|||Number
675207|NCT01641991|Secondary|Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After the 6-month Boost Vaccination by Maximum Severity.|Participants maintained a memory aid to record daily the occurrence of solicited systemic reactions of fatigue, muscle aches, and headache for 8 days after the 6-month intramuscular boost vaccination based on their interference with daily activities. Severe reactions prevented daily activities, moderate reactions interfered with but did not prevent daily activities, and mild reactions did not interfere with daily activities. Participants are counted by the maximum severity they reported experiencing the reaction on any of the 8 days.|Days 0-7 after vaccination at Month 6|The analysis population includes all participants who received the 6-month boost vaccination.||participants|||Number
676269|NCT01627561|Secondary|Anti-HPV-16/18 Seroconversion Rates Assessed by Pseudovirion-Based Neutralization Assay (PBNA) in a Sub-cohort in Group MMR_DTPa||At Day 0, Month 7 and Month 12||12/2016||||
675208|NCT01641991|Secondary|Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 28 by Maximum Severity.|Participants maintained a memory aid to record daily the occurrence of solicited systemic reactions of fatigue, muscle aches, and headache for 8 days after vaccination based on their interference with daily activities. Severe reactions prevented daily activities, moderate reactions interfered with but did not prevent daily activities, and mild reactions did not interfere with daily activities. Participants are counted by the maximum severity they reported experiencing the reaction on any of the 8 days.|Days 0-7 after vaccination at Day 28|The analysis population includes all participants who were vaccinated at Day 28 per protocol, excluding 59 participants at one clinic site who were vaccinated in the fatty tissue over the triceps rather than the intended inferior deltoid.||participants|||Number
675209|NCT01641991|Secondary|Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 14 by Maximum Severity.|Participants maintained a memory aid to record daily the occurrence of solicited systemic reactions of fatigue, muscle aches, and headache for 8 days after vaccination based on their interference with daily activities. Severe reactions prevented daily activities, moderate reactions interfered with but did not prevent daily activities, and mild reactions did not interfere with daily activities. Participants are counted by the maximum severity they reported experiencing the reaction on any of the 8 days.|Days 0-7 after vaccination at Day 14|The analysis population includes all participants who were vaccinated at Day 14 per protocol, excluding 59 participants at one clinic site who were vaccinated in the fatty tissue over the triceps rather than the intended inferior deltoid.||participants|||Number
675210|NCT01641991|Secondary|Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 0 by Maximum Severity.|Participants maintained a memory aid to record daily the occurrence of solicited systemic reactions of fatigue, muscle aches, and headache for 8 days after vaccination based on their interference with daily activities. Severe reactions prevented daily activities, moderate reactions interfered with but did not prevent daily activities, and mild reactions did not interfere with daily activities. Participants are counted by the maximum severity they reported experiencing the reaction on any of the 8 days.|Days 0-7 after vaccination at Day 0|The analysis population includes all participants who were vaccinated at Day 0 per protocol, excluding 59 participants at one clinic site who were vaccinated in the fatty tissue over the triceps rather than the intended inferior deltoid.||participants|||Number
675211|NCT01641991|Secondary|Peak Geometric Mean Concentration (GMC) of ELISA Anti-PA IgG Antibody Through Day 100|Blood was collected from all participants prior to vaccination and at scheduled follow up visits weekly through Day 70, at Day 84 and at Day 100 for testing in the ELISA assay to determine the anti-PA IgG antibody concentration. To determine the group peak GMC, the highest antibody concentration assessed for each subject at any post vaccination visit through Day 100 was determined. The geometric mean of subjects' peak concentrations was calculated along with the 95% confidence intervals.|Day 7 through Day 100|The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all doses in the primary series, completed all scheduled visits up to and including the Day 100 visit in-window, and who contributed both pre- and post-vaccination blood samples for testing for which valid results were reported.||µg/mL||95% Confidence Interval|Geometric Mean
675212|NCT01641991|Secondary|TNA NF50 Geometric Mean Titers (GMT) at Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100.|Blood was collected from all participants prior to vaccination and at scheduled follow up visits weekly through Day 70, at Day 84 and at Day 100 for testing in the toxin neutralization antibody assay to determine the NF50 antibody titer. The geometric mean of subjects' visit-specific titers were calculated along with the 95% confidence intervals. If the antibody titer was below the lower limit of quantification (LLOQ) for the assay, half the value of LLOQ (0.03) was imputed. When all subjects' titers were below LLOQ resulting in no variability within the group, the 95% CI was not calculated.|Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100.|The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all doses in the primary series, completed all scheduled visits up to and including the Day 100 visit in-window, and who contributed both pre- and post-vaccination blood samples for testing for which valid results were reported.||titer||95% Confidence Interval|Geometric Mean
675213|NCT01641991|Secondary|Number of Participants With Injection Site Edema and Erythema With a Size of Greater Than 120 Millimeters (mm)|Participants were given a ruler with the memory aid to measure the occurrence of edema (swelling) and erythema (redness) daily for at least 8 days after each vaccination. Participants are counted in this outcome measure if they had measurements of greater than 120 mm in the 8-day period after at least one vaccination, first separately for edema and erythema, and in the last category, edema and/or erythema, if they had either or both reactions of greater than 120 mm.|Days 0-7 after each vaccination|The analysis population includes all participants who were vaccinated per protocol, excluding 59 participants at one clinic site who were vaccinated in the fatty tissue over the triceps rather than the intended inferior deltoid.||participants|||Number
675214|NCT01641991|Secondary|Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following the 6-month Boost by Maximum Severity|Participants maintained a memory aid to record daily the occurrence of local reactions for 8 days after the 6-month intramuscular boost vaccination based on their interference with daily activities (pain, itchiness, warmth, and tenderness at injection site, arm motion limitation) or based on a quantitative measurement of the reaction (edema, erythema). In the subjective grading scale, severe reactions prevented daily activities, moderate reactions interfered with but did not prevent daily activities, and mild reactions did not interfere with daily activities. For the quantitative scale, severe reactions greater than 100 millimeters (mm), moderate reactions were 51-100 mm, and mild reactions were 25-50 mm. Participants are counted by the maximum severity they reported experiencing the reaction on any of the 8 days.|Days 0-7 after vaccination at Month 6|The analysis population includes all participants who received the 6-month booster vaccination.||participants|||Number
675238|NCT01641939|Secondary|Maximum Observed Plasma Concentration (Cmax) of N2'-Deacetyl-N2'-(3-mercapto-1-oxopropyl)-Maytansine (DM1) - Stage 1|Maximum observed plasma concentration of DM1 were reported. Stage 1 consists of all participants recruited before the regimen selection decision. Regimen selection analysis was carried out after 12 weeks of randomization.|C1D1 and C1C4, C1D2, C1D3, C1D4/C1D5, C1D8, C1D15, C2D1 (up to 12 weeks)|Participants who had at least one PK parameter estimated were included for analysis. Here, n=number of participants evaluable at specified timepoint.||nanogram per milliliter (mcg/mL)||Standard Deviation|Mean
675215|NCT01641991|Secondary|Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 28 by Maximum Severity|Participants maintained a memory aid to record daily the occurrence of local reactions for 8 days after vaccination based on their interference with daily activities (pain, itchiness, warmth, and tenderness at injection site, arm motion limitation) or based on a quantitative measurement of the reaction (edema, erythema). In the subjective grading scale, severe reactions prevented daily activities, moderate reactions interfered with but did not prevent daily activities, and mild reactions did not interfere with daily activities. For the quantitative scale, severe reactions greater than 100 millimeters (mm), moderate reactions were 51-100 mm, and mild reactions were 25-50 mm. Participants are counted by the maximum severity they reported experiencing the reaction on any of the 8 days.|Days 0-7 after vaccination at Day 28|The analysis population includes all participants who were vaccinated at Day 28 per protocol, excluding 59 participants at one clinic site who were vaccinated in the fatty tissue over the triceps rather than the intended inferior deltoid.||participants|||Number
675216|NCT01641991|Secondary|Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 14 by Maximum Severity|Participants maintained a memory aid to record daily the occurrence of local reactions for 8 days after vaccination based on their interference with daily activities (pain, itchiness, warmth, and tenderness at injection site, arm motion limitation) or based on a quantitative measurement of the reaction (edema, erythema). In the subjective grading scale, severe reactions prevented daily activities, moderate reactions interfered with but did not prevent daily activities, and mild reactions did not interfere with daily activities. For the quantitative scale, severe reactions greater than 100 millimeters (mm), moderate reactions were 51-100 mm, and mild reactions were 25-50 mm. Participants are counted by the maximum severity they reported experiencing the reaction on any of the 8 days.|Days 0-7 after vaccination at Day 14|The analysis population includes all participants who were vaccinated at Day 14 per protocol, excluding 59 participants at one clinic site who were vaccinated in the fatty tissue over the triceps rather than the intended inferior deltoid.||participants|||Number
675217|NCT01641991|Secondary|Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 0 by Maximum Severity|Participants maintained a memory aid to record daily the occurrence of local reactions for 8 days after vaccination based on their interference with daily activities (pain, itchiness, warmth, and tenderness at injection site, arm motion limitation) or based on a quantitative measurement of the reaction (edema, erythema). In the subjective grading scale, severe reactions prevented daily activities, moderate reactions interfered with but did not prevent daily activities, and mild reactions did not interfere with daily activities. For the quantitative scale, severe reactions greater than 100 millimeters (mm), moderate reactions were 51-100 mm, and mild reactions were 25-50 mm. Participants are counted by the maximum severity they reported experiencing the reaction on any of the 8 days.|Days 0-7 after vaccination at Day 0|The analysis population includes all participants who were vaccinated at Day 0 per protocol, excluding 59 participants at one clinic site who were vaccinated in the fatty tissue over the triceps rather than the intended inferior deltoid.||participants|||Number
675218|NCT01641991|Secondary|Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG)|Blood was collected from all participants prior to vaccination and at scheduled follow up visits weekly through Day 70, at Day 84 and at Day 100 for testing in the ELISA assay to determine the anti-PA IgG antibody concentration. The geometric mean of subjects' visit-specific titers were calculated along with the 95% confidence intervals. If the antibody titer was below the lower limit of quantification (LLOQ) for the assay, half the value of LLOQ (4.64) was imputed. When all subjects' titers were below LLOQ resulting in no variability within the group, the 95% CI was not calculated.|Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100.|The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all doses in the primary series, completed all scheduled visits up to and including the Day 100 visit in-window, and who contributed both pre- and post-vaccination blood samples for testing for which valid results were reported.||µg/mL||95% Confidence Interval|Geometric Mean
675219|NCT01641991|Primary|Number of Participants With a Four-fold or Greater Increase From Baseline in Toxin Neutralization Antibody Assay (TNA) 50 Percent Neutralization Factor ( NF50 ) Antibody Titer|Blood was collected from all participants prior to vaccination and at scheduled follow up visits weekly through Day 70, at Day 84 and at Day 100 for testing in the toxin neutralization antibody assay to determine the NF50 antibody titer. A participant met the threshold of a 4-fold rise in NF50 antibody titer if the post vaccination titer was an increase by 4-fold or more from the baseline (Day 0) titer.|Days 0, 7, 14, 21, 28 35, 42, 49, 56, 63, 70, 84 and 100|The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all doses in the primary series, completed all scheduled visits up to and including the Day 100 visit in-window, and who contributed both pre- and post-vaccination blood samples for testing for which valid results were reported.||participants|||Number
675220|NCT01641978|Secondary|Years of Professional Experience for Nurses in Critical Care|Influence of professional experience in the evaluation of neurological patients|1 year|Nurses with a minimum experience of three years in intensive care||years||Inter-Quartile Range|Median
675221|NCT01641978|Secondary|Severity in Glasgow Coma Scale (GCS) by Groups.|"The Glasgow Coma Scale is divided into three components which are scored separately: ocular response (assessment 1-4 points), motor response (assessment 1-6 points) verbal response (evaluation of 1-5 points).
Scores for each component are added together to get the total that will range between a minimum of 3 points (which corresponds to a patient who does not open his eyes and no motor response to stimulation or verbal response) and a maximum value of 15 points (corresponding to a patient with open eyes, obeying orders and maintaining a consistent language).
It has been considered that the GCS score between 15 and 13 points corresponds to a slight alteration of consciousness, a score of 12-9 points with moderate impairment and 8 points or less with a serious deterioration in level of consciousness."|1 year|Neurological and/or neurosurgical patients in ICU||percentage of correlation||95% Confidence Interval|Number
675222|NCT01641978|Primary|Interobserver Correlation|interobserver agreement of the Glasgow Coma Scale (GCS) among ICU nurses measured by the intraclass correlation coefficient (ICC) with confidence interval (CI) 95%|1 year|||percentage of correlation||95% Confidence Interval|Number
676270|NCT01627561|Secondary|Anti-HPV-16/18 Antibody Titres Assessed by ELISA in Groups HPV_2D, HPV_2D CO and HPV_3D.||At Day 0 and Months 7, 12, 18, 24 and 36||12/2016||||
675223|NCT01641952|Secondary|Health Assessment Questionnaire (HAQ) Score at Week 20|HAQ is a self-completed patient questionnaire specific for rheumatoid arthritis (RA). It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities. Each domain has at least 2 component questions. There are 4 possible responses for each component 0=without any difficulty 1=with some difficulty 2=with much difficulty 3=unable to do. Calculate HAQ the patient must have a domain score for at least 6 of 8 domains. The HAQ is the sum of the scores, divided by the number of domains that have a score (in range 6-8) for a total possible score minimum/maximum 0 (best) to 3 (worst). A negative change from baseline indicated improvement.|Baseline and Week 20|Intent to treat population included all participants who has fulfilled the eligibility criteria, and signed the informed consent form, participated to the screening exam, and have completed the baseline visit and at least one further assessment. Here, number of participant analysed is the participants who were evaluable for this outcome measure.||units on a scale||Standard Deviation|Mean
675224|NCT01641952|Primary|Number of Participants With Adverse Events (AE)|An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Up to 39 months|Safety population included all participants who received at least one dose of study treatment.||participants|||Number
675225|NCT01641952|Primary|Number of Participants With Remission (DAS28 <2.6) and Low Disease Activity Following Each Treatment Course for Subgroup of Participants Who Had Been Treated With Etanercept or Adalimumab or Infliximab Before Rituximab|The DAS28 score is a measure of the participant's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity], and ESR. DAS28 total scores range from 0 to 10. DAS28 <=3.2 indicates low disease activity, DAS28 >3.2 to 5.1 indicates moderate to high disease activity. A negative change from Baseline (CFB) indicates improvement. The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of CFB and the level of disease activity reached. Good response: DAS28 <=3.2 and a CFB >1.2. Moderate response: DAS28 <=3.2 and CFB >0.6 to <=1.2, DAS28 >3.2 to <=5.1 and CFB >1.2 or >0.6 to <=1.2, DAS28 >5.1 and CFB >1.2. No response: DAS28 <=3.2 and CFB >=0.6, DAS28 >3.2 to <=5.1 and CFB <=0.6, DAS28 >5.1 and CFB >0.6 to <=1.2 or <=0.6.|Week 20|Full analysis population included all participants who has fulfilled the eligibility criteria, and signed the informed consent form, participated at the screening examination. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.||participants|||Number
675226|NCT01641952|Primary|Percentage of Participants With Remission (DAS28 <2.6) and Low Disease Activity Following Each Treatment Course|DAS28 was calculated from SJC and TJC using an assessment of 28 joints, the erythrocyte sedimentation rate (ESR) (milliliter per hour [ml/hr]), and Patient's Global Assessment (PGH) of disease activity (measured on a 0 to 100 mm Visual Analogue Scale [VAS] where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using the following formula: DAS28 = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*PGH of disease activity. Total score range: 0-10, with a higher score indicated more disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission.|Week 20|Full analysis population included all participants who has fulfilled the eligibility criteria, and signed the informed consent form, participated at the screening examination. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.||percentage of participants|||Number
675227|NCT01641952|Primary|Percentage of Participants With EULAR Response in Subgroup of Participants Who Had Been Treated With Anti-TNF Previously|The DAS28 score is a measure of the participant's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity], and ESR. DAS28 total scores range from 0 to 10. DAS28 <=3.2 indicates low disease activity, DAS28 >3.2 to 5.1 indicates moderate to high disease activity. A negative CFB indicates improvement. The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of CFB and the level of disease activity reached. Good response: DAS28 <=3.2 and a CFB >1.2. Moderate response: DAS28 <=3.2 and CFB >0.6 to <=1.2, DAS28 >3.2 to <=5.1 and CFB >1.2 or >0.6 to <=1.2, DAS28 >5.1 and CFB >1.2. No response: DAS28 <=3.2 and CFB >=0.6, DAS28 >3.2 to <=5.1 and CFB <=0.6, DAS28 >5.1 and CFB >0.6 to <=1.2 or <=0.6.|Week 20|Full analysis population included all participants who has fulfilled the eligibility criteria, and signed the informed consent form, participated at the screening examination. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.||percentage of participants|||Number
675228|NCT01641952|Primary|Percentage of Participants With EULAR Response|The DAS28 score is a measure of the participant’s disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity], and ESR. DAS28 total scores range from 0 to 10. DAS28 <=3.2 indicates low disease activity, DAS28 >3.2 to 5.1 indicates moderate to high disease activity. A negative CFB indicates improvement. The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of CFB and the level of disease activity reached. Good response: DAS28 <=3.2 and a CFB >1.2. Moderate response: DAS28 <=3.2 and CFB >0.6 to <=1.2, DAS28 >3.2 to <=5.1 and CFB >1.2 or >0.6 to <=1.2, DAS28 >5.1 and CFB >1.2. No response: DAS28 <=3.2 and CFB >=0.6, DAS28 >3.2 to <=5.1 and CFB <=0.6, DAS28 >5.1 and CFB >0.6 to <=1.2 or <=0.6.|Week 20|Full analysis population included all participants who has fulfilled the eligibility criteria, and signed the informed consent form, participated at the screening examination. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.||percentage of participants|||Number
675239|NCT01641939|Secondary|Maximum Observed Plasma Concentration (Cmax) of Trastuzumab Emtansine (T-DM1) and Total Trastuzumab - Stage 1|Maximum observed plasma concentration of Trastuzumab Emtansine (T-DM1) and total trastuzumab were reported. Stage 1 consists of all participants recruited before the regimen selection, which was carried out after 12 weeks of randomization.|Day 1 (D1) of Cycle 1 (C1) and C4, C1D2, C1D3, C1D4/C1D5, C1D8, C1D15, C2D1 (up to 12 weeks)|Participants who had at least one PK parameter estimated were included for analysis. Here, n=number of participants evaluable at specified timepoint.||microgram per milliliter (mcg/mL)||Standard Deviation|Mean
675229|NCT01641952|Primary|Percentage of Participants With Change in DAS28-ESR of Greater Than or Equal (>=) 1.2 After First Course of Treatment|DAS28 was calculated from SJC and TJC using an assessment of 28 joints, the erythrocyte sedimentation rate (ESR) (milliliter per hour [ml/hr]), and Patient's Global Assessment (PGH) of disease activity (measured on a 0 to 100 mm Visual Analogue Scale [VAS] where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using the following formula: DAS28 = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*PGH of disease activity. Total score range: 0-10, with a higher score indicated more disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission.|Week 20|Full analysis population included all participants who has fulfilled the eligibility criteria, and signed the informed consent form, participated at the screening examination. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.||percentage of participants|||Number
675230|NCT01641952|Primary|Mean DAS28-ESR Score at Visit 4 (Week 20)|DAS28 was calculated from SJC and TJC using an assessment of 28 joints, the erythrocyte sedimentation rate (ESR) (milliliter per hour [ml/hr]), and Patient's Global Assessment (PGH) of disease activity (measured on a 0 to 100 mm Visual Analogue Scale [VAS] where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using the following formula: DAS28 = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*PGH of disease activity. Total score range: 0-10, with a higher score indicated more disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission.|Week 20|Full analysis population included all participants who has fulfilled the eligibility criteria, and signed the informed consent form, participated at the screening examination. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.||units on a scale||Standard Deviation|Mean
675231|NCT01641952|Primary|Change From Baseline in DAS28-ESR at Week 20|DAS28 was calculated from SJC and TJC using an assessment of 28 joints, the erythrocyte sedimentation rate (ESR) (milliliter per hour [ml/hr]), and Patient's Global Assessment (PGH) of disease activity [measured on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0=no disease activity and 100=worst disease activity]. DAS28 was calculated using the following formula: DAS28 = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*PGH of disease activity. Total score range: 0-10, with a higher score indicated more disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission.|Baseline and Week 20|Full analysis population included all participants who has fulfilled the eligibility criteria, and signed the informed consent form, participated at the screening examination. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.||units on a scale||95% Confidence Interval|Mean
675232|NCT01641952|Primary|Percentage of Participant With Good or Moderate Response According to European League Against Rheumatism (EULAR) Response Criteria|The DAS28 score is a measure of the participant’s disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity], and ESR. DAS28 total scores range from 0 to 10. DAS28 <=3.2 indicates low disease activity, DAS28 >3.2 to 5.1 indicates moderate to high disease activity. A negative change from Baseline indicates improvement. The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline (CFB) and the level of disease activity reached. Good response: DAS28 <=3.2 and a CFB >1.2. Moderate response: DAS28 <=3.2 and CFB >0.6 to <=1.2, DAS28 >3.2 to <=5.1 and CFB >1.2 or >0.6 to <=1.2, DAS28 >5.1 and CFB >1.2. No response: DAS28 <=3.2 and CFB >=0.6, DAS28 >3.2 to <=5.1 and CFB <=0.6, DAS28 >5.1 and CFB >0.6 to <=1.2 or <=0.6.|Week 20|Full analysis population included all participants who has fulfilled the eligibility criteria, and signed the informed consent form, participated at the screening examination. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.||percentage of participants|||Number
675233|NCT01641939|Secondary|Systemic Clearance (CL) - Stage 1|CL is a quantitative measure of the rate at which a drug substance is removed from the body. Stage 1 consists of all participants recruited before the regimen selection decision. Regimen selection analysis was carried out after 12 weeks of randomization.|D1C1 and D1C4, C1D2, C1D3, C1D4/C1D5, C1D8, C1D15, C2D1 (up to 12 weeks)|Participants who had at least one PK parameter estimated were included for analysis.||mL/day/kg||Standard Deviation|Mean
675234|NCT01641939|Secondary|Volume of Distribution at Steady State (Vss) - Stage 1|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state. Stage 1 consists of all participants recruited before the regimen selection decision. Regimen selection analysis was carried out after 12 weeks of randomization.|D1C1 and D1C4, C1D2, C1D3, C1D4/C1D5, C1D8, C1D15, C2D1 (up to 12 weeks)|Participants who had at least one PK parameter estimated were included for analysis.||milliliter per kilogram (mL/kg)||Standard Deviation|Mean
675235|NCT01641939|Secondary|Plasma Decay Half-Life (t1/2) - Stage 1|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Stage 1 consists of all participants recruited before the regimen selection decision. Regimen selection analysis was carried out after 12 weeks of randomization.|D1C1 and D1C4, C1D2, C1D3, C1D4/C1D5, C1D8, C1D15, C2D1 (up to 12 weeks)|Participants who had at least one PK parameter estimated were included for analysis.||days||Standard Deviation|Mean
675236|NCT01641939|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf] - Stage 1|AUCinf= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf). Stage 1 consists of all participants recruited before the regimen selection decision. Regimen selection analysis was carried out after 12 weeks of randomization.|D1C1 and D1C4, C1D2, C1D3, C1D4/C1D5, C1D8, C1D15, C2D1 (up to 12 weeks)|Participants who had at least one PK parameter estimated were included for analysis.||day*mcg/mL||Standard Deviation|Mean
675506|NCT01638468|Secondary|Procedure Related Adverse Event Rate|Number of procedure related adverse events occurring within 3 months of the index procedure|3 months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint||events|||Number
675240|NCT01641939|Secondary|Time to Advanced Gastric Cancer (AGC) Symptom Progression - Phase 3|Time to AGC symptom were defined as the time from randomization to the first documentation of an increase in at least one of the pre-specified abdominal discomfort, loss of appetite, weakness and fatigue, upper abdominal pain, change in bowel movement, and weight loss subscales of the QLQ STO22 and EORTC QLQ-C30. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure.|Day 1 of each treatment cycle, at the study drug completion visit, and thereafter at survival follow-up (up to 2 years 3 months)|ITT population included all randomized participants, participants grouped according to the therapy they were randomized to receive. Here, N=number of participants evaluable for this measure.||months||95% Confidence Interval|Median
675241|NCT01641939|Secondary|Percentage of Participants With Advanced Gastric Cancer (AGC) Symptom Progression - Phase 3|AGC symptomatic progression: a worsening of >=10-points in any 1 of the abdominal discomfort, loss of appetite, weakness and fatigue, upper abdominal pain, change in bowel movement, and/or weight loss scales of the EORTC QLQ-C30 and QLQ-STO22. QLQ-STO22 supplements EORTC QLQ-C30 to assess symptoms and commonly reported treatment-related side effects. There are 22 questions comprise 5 scales (dysphagia, pain, reflux symptom, diet restrictions, anxiety), 4 single items (dry mouth, hair loss, taste, body image), which are related to the symptoms of the disease. Most questions used 4-point scale (1 ‘Not at all’ to 4 ‘Very much’). All scores and single-items transformed to a scale of 0-100; higher score=better level of functioning or greater degree of symptoms. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure.|Day 1 of each treatment cycle, at the study drug completion visit, and thereafter at survival follow-up (up to 2 years 3 months)|ITT population included all randomized participants, participants grouped according to the therapy they were randomized to receive. Here, N=number of participants evaluable for this measure.||percentage of participants|||Number
675242|NCT01641939|Secondary|Percentage of Participants With Clinically Significant Improvement in Quality of Life Questionnaire Stomach Cancer Module 22 (QLQ-STO22) Score - Phase 3|The Quality of Life Questionnaire Stomach Cancer Module 22 (QLQ-STO22) supplements the EORTC QLQ-C30 to assess symptoms and treatment-related side effects commonly reported in participants. There are 22 questions which comprise 5 scales (dysphagia, pain, reflux symptom, dietary restrictions, and anxiety) and 4 single items (dry mouth, hair loss, taste, body image). Most questions use 4-point scale (1 ‘Not at all’ to 4 ‘Very much’; 1 question was a yes or no answer). A linear transformation was used to standardize all scores and single-items to a scale of 0 to 100; higher score=better level of functioning or greater degree of symptoms. Change of >=10 points has been found to be clinically significant. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure.|Day 1 of each treatment cycle, at the study drug completion visit, and thereafter at survival follow-up (up to 2 years 3 months)|ITT population included all randomized participants, participants grouped according to the therapy they were randomized to receive. Here, N=number of participants with baseline and at least one post-baseline valid score.||percentage of participants||95% Confidence Interval|Number
675243|NCT01641939|Secondary|Percentage of Participants With Clinically Significant Improvement in European Organisation for Research and Treatment of Cancer Quality of Life Core Module 30 (EORTC QLQ-C30) Score - Phase 3|The EORTC QLQ-C30 is a validated, cancer-specific 30-item patient-reported measure, and contains 14 domains to assess the impact of cancer treatment on 5 aspects of participants functioning (physical, role, cognitive, emotional, and social), 9 aspects of disease/treatment-related symptoms (fatigue, nausea and vomiting, pain, dyspnea, insomnia, loss of appetite, constipation, diarrhea) and a global QoL/overall health status scale. Questions used 4 point scale (1 ‘Not at all’ to 4 ‘Very much’; with the exception of the QoL/health status scale which uses a 7-point scale (1 ‘very poor’ to 7 ‘Excellent’). Each scale is transformed on a scale of 0-100; a higher score equals (=) a better level of functioning or greater degree of symptoms. Change of greater than or equal to (>=) 10-points has been found to be clinically significant. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure.|Day 1 of each treatment cycle, at the study drug completion visit, and thereafter at follow-up (up to 2 years 3 months)|ITT population included all randomized participants, participants grouped according to the therapy they were randomized to receive. Here, N=number of participants with baseline and at least one post-baseline valid score.||percentage of participants||95% Confidence Interval|Number
675244|NCT01641939|Secondary|Duration of Objective Response (DOR) - Phase 3|DOR: time from the date when a clinical response [CR or PR] was first documented to the date of first documented progressive disease (PD) or death. CR:disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR: >= 30% decrease in sum of the LD of all target lesions taking as reference the screening sum LD. PD: could base on symptom deterioration or at least a 20% increase in the sum of diameters of target or non-target lesions and new lesions, taking as reference the smallest sum on study (nadir), including baseline. To be assigned a status of PR or CR, changes in tumor measurements had to be confirmed by repeat assessments that should have been performed no less than 4 weeks after the criteria for response were first met. Longer intervals as determined by the study protocol were also appropriate. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure.|Date of randomization until disease progression or death, whichever occurred first (assessed at baseline, every 6 weeks up to 2 years 3 months)|ITT population included all randomized participants, participants grouped according to the therapy they were randomized to receive. Here, N=number of participants evaluable for this outcome measure.||months||95% Confidence Interval|Median
675253|NCT01641926|Primary|Percentage of HBeAg(-) Participants Achieving Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels <2000 IU/mL at 24 Weeks Post-treatment|The Roche COBAS TaqMan HBV-(High Pure System Assay) was used to measure HBV DNA in blood samples of HBeAg(-) participants. The percentage of HBeAg(-) participants with HBV DNA <2000 IU/mL at 24 weeks post-treatment was reported.|FU Week 24 (Study Week 72)|All randomized HBeAg(-) participants who received ≥1 dose of study medication. HBeAg(+) participants were not included in this analysis.||percentage of participants|||Number
675511|NCT01638468|Secondary|Pulmonary Systolic Arterial Blood Pressure|Pulmonary systolic arterial blood pressure at termination of the index procedure.|Post Index Procedure|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 1 participants were not evaluable.||mmHg||Standard Deviation|Mean
675245|NCT01641939|Secondary|Percentage of Participants With Objective Response According to mRECIST v1.1 - Phase 3|Objective response referred to participants with complete response (CR) or partial response (PR). CR: disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR: greater than or equal to (>=) 30% decrease in sum of the longest diameter (LD) of all target lesions taking as reference the screening sum LD. To be assigned a status of PR or CR, changes in tumor measurements had to be confirmed by repeat assessments that should have been performed no less than 4 weeks after the criteria for response were first met. Longer intervals as determined by the study protocol were also appropriate. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure.|Date of randomization until disease progression or death, whichever occurred first (assessed at baseline, every 6 weeks up to 2 years 3 months)|ITT population included all randomized participants, participants grouped according to the therapy they were randomized to receive. Here, N=number of participants with measurable disease were included in analysis of this outcome measure.||percentage of participants||95% Confidence Interval|Number
675246|NCT01641939|Secondary|Progression Free Survival (PFS) According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST v1.1) - Phase 3|Progression-free survival was defined as the time between the date of randomization and the first date of documented progression or date of death due to any cause, whichever occurred first. Tumor assessment was performed using modified RECIST v1.1. Progressive disease could base on symptom deterioration or was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions. Kaplan-Meier estimates were used for analysis. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure. The confirmatory analyses are restricted to comparisons between the taxane arm and the selected trastuzumab emtansine arm (2.4 mg).|Date of randomization until disease progression or death, whichever occurred first (assessed at baseline, every 6 weeks up to 2 years 3 months)|ITT population included all randomized participants; participants grouped according to the therapy they were randomized to receive.||months||95% Confidence Interval|Median
675247|NCT01641939|Secondary|Percentage of Participants With Disease Progression or Death According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST v1.1) - Phase 3|Progressive disease could base on symptom deterioration or was defined as at least a 20 percent (%) increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions. Tumor assessment was performed using modified RECIST v1.1. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure.|Date of randomization until disease progression or death, whichever occurred first (assessed at baseline, every 6 weeks up to 2 years 3 months)|ITT population included all randomized participants; participants grouped according to the therapy they were randomized to receive.||percentage participants|||Number
675248|NCT01641939|Primary|Overall Survival (OS) - Phase 2 (Dose Selection Portion of the Study)|Overall survival was defined as the time between the date of randomization and date of death due to any cause. Kaplan-Meier estimates were used for analysis. Participants for whom no death was reported prior to an analysis cutoff (10 August 2013) was censored at the latest date before the cutoff in which they were known to be alive.|Date of randomization until death (up to 1 year)|Analysis population included all participants that had been enrolled in phase 2 (stage 1) up to a clinical cut-off date of 10 August 2013; participants grouped according to the therapy they were randomized to receive. Here, N (number of participants analyzed)=number of evaluable participants during phase 2 up to 10 August 2013.||weeks||95% Confidence Interval|Median
675249|NCT01641939|Primary|Overall Survival (OS)- Phase 3|Overall survival was defined as the time between the date of randomization and date of death due to any cause. Kaplan-Meier estimates were used for analysis. Participants for whom no death was reported prior to an analysis cutoff (30 June 2015) was censored at the latest date before the cutoff in which they were known to be alive. All data from the standard taxane therapy and trastuzumab emtansine 2.4 mg (selected treatment arm) from phase 2 and phase 3 (Stage 2) are combined into phase 3 data, and thus cumulative data are provided within the results presented for phase 3. The confirmatory analyses are restricted to comparisons between the taxane arm and the selected trastuzumab emtansine arm (2.4 mg).|Date of randomization until death (up to 2 years 3 months)|ITT population included all randomized participants; participants grouped according to the therapy they were randomized to receive.||months||95% Confidence Interval|Median
675250|NCT01641926|Secondary|Percentage of HBeAg(+) Participants Achieving the Combined Response of HBeAg Seroconversion and HBV DNA <2000 IU/mL at 24 Weeks Post-treatment|HBeAg seroconversion was defined as loss of HBeAg in HBeAg(+) participants and development of antibody to HBeAg. HBV DNA levels in blood were measured by the Roche COBAS TaqMan HBV-(High Pure System Assay). The percentage of HBeAg(+) participants with the combined response of achieving both HBeAg conversion and HBV DNA levels <2000 IU/mL at 24 weeks post-treatment was reported.|FU Week 24 (Study Week 72)|All randomized HBeAg(+) participants who received ≥1 dose of study medication. HBeAg(-) participants were not included in this analysis.||percentage of participants|||Number
675251|NCT01641926|Secondary|Percentage of HBeAg(+) and HBeAg(-) Participants Achieving Alanine Aminotransferase (ALT) Normalization at 24 Weeks Post-treatment|ALT normalization is a desired goal of HBV treatment, which is defined as having abnormal ALT levels at baseline and subsequently normal ALT levels after receiving treatment, where normal is defined as ≤ 1x the upper limit of normal (ULN). The percentage of HBeAg(+) and HBeAg(-) participants achieving ALT normalization at 24 weeks post-treatment was reported.|FU Week 24 (Study Week 72)|All randomized HBeAg(+) and HBeAg(-) participants who received ≥1 dose of study medication.||percentage of participants|||Number
675252|NCT01641926|Secondary|Percentage of HBeAg(+) Participants Achieving HBV DNA <2000 IU/mL at 24 Weeks Post-treatment|The Roche COBAS TaqMan HBV-(High Pure System Assay) was used to measure HBV DNA in blood samples of HBeAg(+)participants. The percentage of HBeAg(+) participants with HBV DNA <2000 IU/mL at 24 weeks post-treatment was reported.|FU Week 24 (Study Week 72)|All randomized HBeAg(+) participants who received ≥1 dose of study medication. HBeAg(-) participants were not included in this analysis.||percentage of participants|||Number
675254|NCT01641926|Primary|Percentage of HBeAg(+) Participants Achieving HBeAg Seroconversion at 24 Weeks Post-treatment|Blood samples were drawn to assess the participant's seroconversion status at Follow-up (FU) Week 24. HBeAg seroconversion was defined as loss of HBeAg in HBeAg(+) participants and development of antibody to HBeAg.|FU Week 24 (Study Week 72)|All randomized HBeAg(+) participants who received ≥1 dose of study medication. HBeAg(-) participants were not analyzed for HBeAg seroconversion.||percentage of participants|||Number
675255|NCT01641900|Secondary|Motor Procedural Memory Performance|Overnight performance improvement on the finger tapping motor sequence task (MST).The MST involves pressing four numerically labeled keys on a standard keyboard with the fingers of the left hand, repeating a 5 digit sequence as quickly and accurately as possible for 12 trials at 30 seconds each separated by 30 sec rest periods. Different sequences were employed for the Placebo and Drug visits in a counter-balanced order. MST performance is measured as the number of correctly typed sequences in each trial. The primary outcome measure is overnight improvement calculated as the percent increase in average of correct sequences from the last three training trials to the average of first three test trials. Since the outcome measure is calculated as percent improvement from training to test for each participant, there is no highest or lowest possible score.|Experimental Night (Night 2)|||percentage of improvement on MST perform||Standard Deviation|Mean
675256|NCT01641900|Primary|Sleep Spindle Density|This measure is averaged for Baseline and Experimental nights. Sleep spindle density (number/minute) for non-Rapid Eye Movement Stage 2 sleep (N2) detected at channel Cz based on polysomnographic recordings.|Spindles will be averaged for the Baseline (Night 1) and Experimental Nights (Night 2)|||Sleep spindle density (number/minutes)||Standard Deviation|Mean
675257|NCT01641861|Secondary|Time Use for Caries Removal|The time taken for the removal of carious dentine was recorded using a stopwatch. Recorded time unit is seconds.|Immediately while treatment|||seconds||Inter-Quartile Range|Median
675258|NCT01641861|Secondary|Levels of Pain and Discomfort|The participants were assessed for the levels of pain and discomfort using the facial visual analogue scale (VAS). The score was recorded in ruler scale from 0-100 millimeters, 0 = no pain and 100 = extreme pain) before treatment with the child sitting on the dental chair and after treatment (completion of carious tissue removal). The difference in the VAS scores before and after treatment was calculated and compared between the two comparison groups.|immediately after treatment|||Pain score from 0-100||Inter-Quartile Range|Median
675259|NCT01641861|Secondary|Number of Participants With Complete Caries Removal|The efficacy of caries removal was evaluated by the visual and tactile criteria. The completeness of caries removal was judged on the basis of clinical criteria involving the inspection of the tooth surfaces using a good light source, dental mirror and explorer. A blunt explorer was used to detect surface roughness by gently stroking across the dentine surfaces and to evaluate the dentine hardness. Complete caries removal was achieved if as remove soft and infected dentine until felt hard and leathery consistency of the dentine surfaces. The tactile criteria include the smooth passage of the blunt explorer and absence of a catch or a “tug-back” sensation.|immediately after treatment|||participants|||Number
675260|NCT01641861|Secondary|Incidence of Secondary Caries|The restoration teeth were assess by clinical and radiographic examination for detection the recurrent caries.|two years|||participants|||Number
675261|NCT01641861|Primary|Number of Participants With Treatment Failure|The dental restorations were evaluated at 6, 12, 18 and 24 months after treatment. Evaluation criteria included the condition of the filling material and presence of secondary caries at the margin of the restorations. The restoration status was re-categorized as a binary outcome: Treatment failure (Yes/No).|two years|||participants|||Number
675262|NCT01641835|Primary|Bruch's Membrane Opening - Minimum Rim Area, Global||3 months|||microns^2||Standard Deviation|Mean
675263|NCT01641835|Primary|Primary Endpoints|The primary endpoints are the structural measurement values of (1) the ONH, (2) the peri-papillary RNFL, and (3) the macula obtained using the Spectralis OCT and the statistical descriptors such as mean, standard deviation, and distribution percentiles.|3 months|||microns||Standard Deviation|Mean
675264|NCT01641822|Secondary|Average Change From Baseline in the CFQ-R Respiratory Symptom Scale (RSS) Score Across All Courses of AZLI/Placebo Treatment (Weeks 4, 12 and 20)|Respiratory symptoms (eg, coughing, congestion, wheezing) were assessed with the Cystic Fibrosis Questionnaire - Revised (CFQ-R) Respiratory Symptoms Scale (RSS). The range of scores (units) was 0 to 100 with higher scores indicating fewer symptoms. The adjusted mean is from a mixed-effect model repeated measures (MMRM) analysis. The model includes terms for baseline value, previous exacerbations (1, 2, ≥ 3), treatment, visit (categorical), and treatment by visit interaction.|Comparative Phase: Baseline and Weeks 4, 12 and 20|Participants in the ITT Analysis Set with available data were analyzed.||units on a scale||Standard Deviation|Mean
675265|NCT01641822|Secondary|Rate of Hospitalizations for a Respiratory Event|The rate of hospitalizations for a respiratory event per participant year was calculated using negative binomial regression analysis.|Baseline in the comparative phase to the end of study (average time on study during the Comparative Phase: 155.4 days)|ITT Analysis Set||hospitalizations per participant year|||Number
675266|NCT01641822|Secondary|Time to First Protocol-defined Pulmonary Exacerbation|The time to first protocol-defined pulmonary exacerbation was calculated using the Kaplan-Meier method.|Baseline in the comparative phase to the end of study (average time on study during the Comparative Phase: 155.4 days)|ITT Analysis Set||days||95% Confidence Interval|Median
675267|NCT01641822|Secondary|Percentage of Participants Who Used Non-study IV or Inhaled Antibiotics for PDEs||Baseline in the comparative phase to the end of study (average time on study during the Comparative Phase: 155.4 days)|ITT Analysis Set||percentage of participants|||Number
675268|NCT01641822|Secondary|Average Actual Change From Baseline in FEV1 % Predicted Across All Courses of AZLI/Placebo Treatment (Weeks 4, 12 and 20)|FEV1 % predicted is defined as FEV1 of the patient divided by the average FEV1 in the population for any person of similar age, sex and body composition. The adjusted mean is from a mixed-effect model repeated measures (MMRM) analysis. The model includes terms for baseline value, previous exacerbations (1, 2, ≥ 3), treatment, visit (categorical), and treatment by visit interaction.|Comparative Phase: Baseline and Weeks 4, 12 and 20|Participants in the ITT Analysis Set with available data were analyzed.||percentage of FEV1 % predicted||Standard Error|Mean
676271|NCT01627561|Secondary|Anti-HPV-16/18 Seroconversion Rates Assessed by ELISA in Groups HPV_2D, HPV_2D CO and HPV_3D.||At Day 0 and Months 7, 12, 18, 24 and 36||12/2016||||
675269|NCT01641822|Primary|Rate of Protocol-defined Exacerbations (PDE) From Baseline Through Week 24|PDEs were characterized by a change or worsening from baseline of 1 or more documented signs or symptoms (decreased exercise tolerance, increased cough, increased sputum or chest congestion, decreased appetite, or other signs or symptoms) associated with the use of non-study IV or inhaled antibiotics and be verified by a blinded independent adjudication committee.|Baseline in the comparative phase to the end of study (average time on study during the Comparative Phase: 155.4 days)|Intent-to-Treat (ITT) Analysis Set: all randomized participants||PDEs per participant year|||Number
675270|NCT01641692|Secondary|Change From Baseline in the Mean Number of Puffs Per Day of Rescue Albuterol/Salbutamol Over Day 7 to Day 14 of Each Treatment Period|The mean number of puffs per day of rescue salbutamol at Baseline (i.e. run-in or washout data) and on-treatment were recorded. Total puffs was calculated as (Number of Puffs + (2 x number of Nebules)). Only the 7 days proceeding each treatment period were included in the Baseline calculations. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Day 7 prior to each treatment period) and the last 7 days of each treatment period (up to Study Day 70)|ITT Population. Only those participants with data available at the specified time points were analyzed.||Number of puffs||Standard Deviation|Mean
675271|NCT01641692|Secondary|Change From Baseline in Mean Morning (AM) and Evening (PM) Pre-treatment Peak Expiratory Flow (PEF) Over Day 7 to Day 14 of Each Treatment Period|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants daily in the morning and evening just prior to each dose, using an electronic peak flow meter, throughout the 14-day Treatment Period. Only the averaged daily AM and PM PEF over Days 7 to 14 was analyzed. The analysis was performed using a mixed effects analysis of covariance model with fixed effect terms for treatment and period; Baseline PEF AM and PM, gender and age fitted as covariates; and participant as a random effect.|Baseline (Day 7 prior to each treatment period) and the last 7 days of each treatment period (up to Study Day 70)|"ITT Population. Only those participants remaining in the study and contributing evaluable data for the indicated parameter were indicated by n=X, X in the category title and the overall number of participants analyzed reflects everyone in the ITT Population."||Liters per minute||Standard Deviation|Mean
675272|NCT01641692|Secondary|Change in Baseline in Serial FEV1 Over 0-24 Hours After the Morning Dose on Day 14 of Each Treatment Period|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Serial FEV1 measurements were taken electronically by spirometry. Serial FEV1 was measured at 5, 15, 30 minutes (min), 1, 3, 6, 9, 12, 16, 20, 23 and 24 hours (h) post-dose. Baseline is the 0h value obtained prior to the AM dose on Day 14 of the treatment period. Change from Baseline was calculated as FEV1 value at the evaluated time point minus Baseline. Analysis was preformed using a repeated measures model with terms for period, treatment, time, mean Baseline, period Baseline, and time by mean Baseline, time by period Baseline, and time by treatment interactions.|Baseline and Day 14 of each treatment period (up to Study Day 70)|"ITT Population. Only those participants remaining in the study and contributing evaluable data for the indicated parameter were indicated by n=X, X in the category title and the overall number of participants analyzed reflects everyone in the ITT Population."||Liters||Standard Error|Least Squares Mean
675273|NCT01641692|Secondary|Change From Baseline (BL) in the Weighted Mean (WM) 0-24 Hour FEV1 Obtained Post-AM Dose on Day 14 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The WM FEV1 was derived by calculating the area under the FEV1/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. Baseline is the 0h value obtained prior to the AM dose on Day 14 of the treatment period. Change from BL at a was calculated as WM at the evaluated time point minus BL. Analysis was performed using a mixed model, including treatment, period, period Baseline FEV1, and mean Baseline FEV1 as fixed effects and participant as a random effect.|Baseline and Day 14 of each treatment period (up to Study Day 70)|ITT Population. Only those participants with data available at the specified time points were analyzed.||Liters||Standard Error|Least Squares Mean
675274|NCT01641692|Primary|Number of Participants With the Indicated 24 Hour Holter Findings|Twenty-four hour Holter ECG measurements were obtained using a 12-lead Holter monitor. The Holter monitor is worn by the participant for 24 hours, and the monitor continuously records the heart’s rhythm while the monitor is worn. Following the 24-hour period, the data from the monitor were downloaded and transmitted to the centralized vendor for analysis and interpretation by a licensed cardiologist. The 24-hour Holter ECG measurements were obtained at during the screening period and on Day 14 of each treatment period. The number of participants with clinically significant change (abnormal or normal) were reported.|Day 14 of each treatment period (up to Study Day 70)|ITT Population. Only participants with sufficient data (at least 16 hours of recorded data) at the specified time points were analyzed.||Participants|||Number
675275|NCT01641692|Primary|Number of Participants With the Indicated Abnormal Electrocardiogram Findings|Electrocardiograph measurements performed at Screening (Visit 1) and at Day 1 and Day 14 (pre-dose, 10 minutes post-dose and 2 hours post-dose.of each treatment period). Any clinically significant findings were identified during participant monitoring.|Day 14 of each treatment period (up to Study Day 70)|ITT Population. Only those participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.||Participants|||Number
675276|NCT01641692|Primary|Urine Specific Gravity on Day 14 of Each Treatment Period|Urine samples were collected for the measurement of urine specific gravity by dipstick method at Day 14. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney’s ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. A urinary specific gravity measurement is a routine part of urinalysis. The reference range is 1.002-1.030.|Day 14 of each treatment period (up to Study Day 70)|ITT Population. Only those participants with data available at the specified time points were analyzed.||Ratio||Standard Deviation|Mean
675277|NCT01641692|Primary|Urine pH on Day 14 of Each Treatment Period|Urine samples were collected for the measurement of urine pH by dipstick method at Day 14. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).|Day 14 of each treatment period (up to Study Day 70)|ITT Population. Only those participants with data available at the specified time points were analyzed.||Scores on a scale||Standard Deviation|Mean
675278|NCT01641692|Primary|Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick on Day 14 of Each Treatment Period|Urinalysis parameters included: Urine Bilirubin (UB), Urine Occult Blood (UOB), Urine Glucose (UG), Urine Ketones (UK), Urine Nitrite (UN), Urine Protein (UP), and Urine Leukocyte Esterase test for detecting White Blood Cell (UWBC). The dipstick was a strip used to detect the presence or absence of these parameters in the urine sample. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative (Neg), Trace (T), 1+, 2+, and 3+, and for UG the result can be read as Neg, T, T or 1/10 G/dL, 1+ or 1/4 G/dL, 3+ or 1 G/dL, indicating proportional concentrations in the urine sample. Data are reported as the number of participants who had neg, T, 1+, 2+ and 3+ levels at Day 14.|Baseline and Day 14 of each treatment period (up to Study Day 70))|"ITT Population. Only those participants remaining in the study and contributing evaluable data for the indicated parameter were indicated by n=X, X in the category title and the overall number of participants analyzed reflects everyone in the ITT Population."||Participants|||Number
675279|NCT01641692|Primary|Change From Baseline in Hematocrit on Day 14 of Each Treatment Period|Blood samples were collected for the measurement of hematocrit (proportion of red blood cells in blood) at Baseline and Day 14. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Day 14 of each treatment period (up to Study Day 70)|ITT Population. Only those participants with data available at the specified time points were analyzed.||Proportion of red blood cells in blood||Standard Deviation|Mean
675280|NCT01641692|Primary|Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood on Day 14 of Each Treatment Period|Blood samples were collected for the measurement of the percentage of basophils, eosinophils, lymphocytes, monocytes, and segmented neutrophils (neut) at Baseline and Day 14. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Day 14 of each treatment period (up to Study Day 70)|"ITT Population. Only those participants remaining in the study and contributing evaluable data for the indicated parameter were indicated by n=X, X in the category title and the overall number of participants analyzed reflects everyone in the ITT Population."||Percentage of cells in blood||Standard Deviation|Mean
675281|NCT01641692|Primary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (ANC - Absolute Neutrophil Count), Platelet, and Leukocytes Count on Day 14 of Each Treatment Period|Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, total neutrophils (ANC - Absolute neutrophil [neut] count), platelet, and leucocytes count at Day 14. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Day 14 of each treatment period (up to Study Day 70)|"ITT Population. Only those participants remaining in the study and contributing evaluable data for the indicated parameter were indicated by n=X, X in the category title and the overall number of participants analyzed reflects everyone in the ITT Population."||10^9 cells/Liter (GI/L)||Standard Deviation|Mean
675282|NCT01641692|Primary|Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) on Day 14 of Each Treatment Period|Blood samples were collected for the measurement of chloride, caron dioxide, glucose, potassium, sodium, and urea/BUN at Baseline and Day 14. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Day 14 of each treatment period (up to Study Day 70)|"ITT Population. Only those participants remaining in the study and contributing evaluable data for the indicated parameter were indicated by n=X, X in the category title and the overall number of participants analyzed reflects everyone in the ITT Population."||Micromoles/Liter (µM/L)||Standard Deviation|Mean
675283|NCT01641692|Primary|Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine on Day 14 of Each Treatment Period|Blood samples were collected for the measurement of direct bilirubin, indirect (ind) bilirubin, total bilirubin, and creatinine at Baseline and Day 14. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Day 14 of each treatment period (up to Study Day 70)|"ITT Population. Only those participants remaining in the study and contributing evaluable data for the indicated parameter were indicated by n=X, X in the category title and the overall number of participants analyzed reflects everyone in the ITT Population."||Micromoles/Liter (µM/L)||Standard Deviation|Mean
675284|NCT01641692|Primary|Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) on Day 14 of Each Treatment Period|Blood samples were collected for the measurement of ALP, ALT, AST, CK, GGT, and LDH at Baseline and Day 14. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Day 14 of each treatment period (up to Study Day 70)|"ITT Population. Only those participants remaining in the study and contributing evaluable data for the indicated parameter were indicated by n=X, X in the category title and the overall number of participants analyzed reflects everyone in the ITT Population."||International Units/Liter (IU/L)||Standard Deviation|Mean
675285|NCT01641692|Primary|Change From Baseline in Albumin, Total Protein, and Hemoglobin on Day 14 of Each Treatment Period|Blood samples were collected for the measurement of albumin, total protein, and hemoglobin at Baseline and Day 14. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Day 14 of each treatment period (up to Study Day 70))|"ITT Population. Only those participants remaining in the study and contributing evaluable data for the indicated parameter were indicated by n=X, X in the category title and the overall number of participants analyzed reflects everyone in the ITT Population."||Grams per liter (G/L)||Standard Deviation|Mean
675286|NCT01641692|Primary|Change From Baseline in Pulse Rate on Day 14 of Each Treatment Period|Pulse rate was measured in a sitting position after the participant was kept at rest for at least 5 minutes. Analysis was performed using a mixed model, including treatment, period, period Baseline and mean Baseline for the measure as fixed effects and participant as a random effect. Baseline is the value recorded pre-dose on Day 1 of each treatment period; mean Baseline is the mean of the Baselines for each participant and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Change from Baseline was calculated as the assessment value at Day 14 minus the Baseline value.|Baseline and Day 14 of each treatment period (up to Study Day 70)|ITT Population. Only those participants with data available at the specified time points were analyzed.||Beats per minute||Standard Error|Least Squares Mean
675287|NCT01641692|Primary|Change From Baseline in Diastolic Blood Pressure on Day 14 of Each Treatment Period|Blood pressure measurement included diastolic blood pressure (DBP). Blood pressure was measured in a sitting position after the participant was kept at rest for at least 5 minutes. Analysis was performed using a mixed model, including treatment, period, period Baseline and mean Baseline for the measure as fixed effects and participant as a random effect. Baseline is the value recorded pre-dose on Day 1 of each treatment period; mean Baseline is the mean of the Baselines for each participant and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Change from Baseline was calculated as the assessment value at Day 14 minus the Baseline value.|Baseline and Day 14 of each treatment period (up to Study Day 70)|ITT Population. Only those participants with data available at the specified time points were analyzed.||Millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
675288|NCT01641692|Primary|Change From Baseline in Systolic Blood Pressure on Day 14 of Each Treatment Period|Blood pressure measurement included systolic blood pressure (SBP). Blood pressure was measured in a sitting position after the participant was kept at rest for at least 5 minutes. Analysis was performed using a mixed model, including treatment, period, period Baseline and mean Baseline for the measure as fixed effects and participant as a random effect. Baseline is the value recorded pre-dose on Day 1 of each treatment period; mean Baseline is the mean of the Baselines for each participant and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Change from Baseline was calculated as the assessment value at Day 14 minus the Baseline value.|Baseline and Day 14 of each treatment period (up to Study Day 70)|ITT Population. Only those participants with data available at the specified time points were analyzed.||Millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
675289|NCT01641692|Primary|Number of Participants With Asthma Exacerbations During the Treatment Period|Worsening of asthma symptoms is monitored throughout the study. Severe exacerbation (deterioration of asthma requiring use of systemic corticosteroids for 3 days, inpatient hospitalization or emergency department visit due to asthma) is an exclusion criterion and requires withdrawal from the study. Asthma symptoms were assessed daily using an electronic diary throughout study.|From Baseline until the end of Treatment Period 3 (up to Study Day 70)|ITT Population. Only those participants with data available at the specified time points were analyzed.||Participants|||Number
675290|NCT01641692|Primary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of SAEs.|From Baseline until the end of Treatment Period 3 (up to Study Day 70)|ITT Population||Participants|||Number
675291|NCT01641692|Primary|Change From Baseline in Trough FEV1 on Day 15 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Treatment Day 15 is defined as the value obtained 24 hours after the morning dose administered on Day 14. Analysis was performed using a mixed model, including treatment, period, period Baseline FEV1 and mean Baseline FEV1 as fixed effects and participant as a random effect. Baseline is the FEV1 value recorded pre-dose on Day 1 of each treatment period; mean Baseline is the mean of the Baselines for each participant and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Change from Baseline for each treatment period is the trough FEV1 at Day 15 minus the Baseline value for that treatment period.|Day 15 of each treatment period (up to Study Day 71)|ITT Population. All participants with >=1 post-Baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 15.||Liters||Standard Error|Least Squares Mean
675292|NCT01641692|Primary|Final Dose-response Model for Trough Forced Expiratory Volume in One Second (FEV1)|Dose-response was conducted for both QD and BID UMEC doses on trough FEV1 (measure of lung function, defined as the maximal amount of air that can be forcefully exhaled in 1 second) on D 15. Total daily dose of UMEC was used in the modeling. The null model was the final model. The null model is defined as: CFEV1,ij=(THETA1+ETA1j)*meanBL+(THETA2+ETA1j)*periodBL+EPSij, where CFEV1,ij represents the change from BL in trough FEV1 for participant j measured at period i. THETA1 and THETA2 were the slopes with respect to meanBL and periodBL, respectively. Omegas were the variance of the slopes on meanBL and periodBL (ETA1j, ETA2j) for each participant and Sigma was the variance of the residual errors (EPSij). MeanBL is the mean of the Baseline (BL) which is the FEV1 value recorded pre-dose on D 1 of each TP; periodBL is the difference between the BL and the meanBL in each TP for each participant.|Day 15 of each treatment period (up to Study Day 71)|Intent-To-Treat (ITT) Population: : all participants randomized to treatment and who received at least one dose of study medication. All participants with >=1 post-Baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 15.||unitless||95% Confidence Interval|Geometric Mean
675293|NCT01641653|Secondary|Percent Intra-op Blood Glucose Level of 140mg/dL or Less|blood glucose level will be tested perioperatively at 30 minute intervals following induction. All glucose levels will be recorded .midazolam group will maintain a blood glucose level perioperatively of 140mg/dL or less|perioperatively|||percentage of glucose levels<140|||Number
675294|NCT01641653|Secondary|Glucose Level Percent Change From Pre-op to Maximum Glucose Level|blood glucose level measured preoperatively, through surgical period and in PACU at 30 min and 60 min|Preoperatively, intraoperatively 30 min for duration of surgery|per protocol||percentage of increase in glucose level||Inter-Quartile Range|Median
675295|NCT01641653|Primary|Maximum Perioperative Blood Glucose Level of 30 Minute Interval Measurements|Non diabetic subjects undergoing hernia repair were randomized into 2 groups. Midazolam vs. placebo. Blood glucose level was monitored preoperatively and following induction of anesthesia at 30 minute intervals perioperatively, and after in the PACU at 30 minutes and 60 minutes following arrival. All readings were performed using the Abbott Freestyle Glucose Monitor.|every 30 min for duration of surgery|per protocol||mg/dL||Inter-Quartile Range|Median
678090|NCT01601977|Primary|Control of Nocturnal Hypoventilation|transcutaneous CO2 recording from overnight sleep study whilst using the device at 6 weeks compared to baseline control when using usual device|baseline, 6 week assessment|||kPa||Standard Deviation|Mean
675297|NCT01641640|Secondary|Percentage of Participants With Viral Breakthrough|Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment, confirmed with 2 consecutive values (second confirmation value could be posttreatment), or last available on-treatment measurement with no subsequent follow-up values.|Baseline to Week 12|Full Analysis Set||percentage of participants|||Number
675298|NCT01641640|Secondary|Percentage of Participants Achieving SVR24|SVR24 was defined as HCV RNA < LLOQ 24 weeks after cessation of therapy|Posttreatment Week 24|Full Analysis Set||percentage of participants|||Number
675299|NCT01641640|Secondary|Percentage of Participants Achieving SVR4|SVR4 was defined as HCV RNA < LLOQ 4 weeks after cessation of therapy|Posttreatment Week 4|Full Analysis Set||percentage of participants|||Number
675300|NCT01641640|Primary|Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug|The number of participants experiencing adverse events leading to permanent discontinuation of study drug was summarized. Adverse events may or may not have been related to study treatment. Participants discontinuing study drug were permitted to remain on the study for further assessments.|Baseline to Week 12|Safety Analysis Set||participants|||Number
675301|NCT01641640|Primary|Percentage of Participants Achieving Sustained Virologic Response (SVR)12|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) 12 weeks after cessation of therapy.|Posttreatment Week 12|Full Analysis Set||percentage of participants|||Number
675306|NCT01641237|Secondary|Enamel Fluoride Uptake (Corrected Data)|Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on amount of fluoride divided by area of the enamel cores. Data analysis was based on corrected data.|Baseline to 4 hours|PP population: All randomized participants who received at least one study product, had one efficacy assessment and did not have any protocol violations deemed to affect efficacy. Missing values were not imputed. Data analysis for this outcome measure was performed based on a correction factor.||micrograms*F/centimeters^2||Standard Error|Mean
675307|NCT01641237|Secondary|Percentage Relative Erosion Resistance|Changes in mineral content of enamel specimens exposed to dietary erosive challenge were determined by measuring the length of the indentations. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine relative erosion resistance which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent relative erosion resistance was calculated by formula: [(E1-E2)/ (E1-B)]*100.|Baseline to 4 hours|PP population: All randomized participants who received at least one study product, had one efficacy assessment and did not have any protocol violations deemed to affect efficacy. Missing values were not imputed.||% Relative Erosion Resistance||Standard Error|Mean
675308|NCT01641237|Secondary|%SMHR|SMHR test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: [(E1-R)/ (E1-B)]*100.|Baseline to 4 hours|PP population: All randomized participants who received at least one study product, had one efficacy assessment and did not have any protocol violations deemed to affect efficacy. Missing values were not imputed.||%SMHR||Standard Error|Mean
675309|NCT01641237|Primary|Percentage Surface Microhardness Recovery (%SMHR) Dose Response Relationship|SMHR test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: [(E1-R)/ (E1-B)]*100.|Baseline to 4 hours|Per protocol population: All randomized participants who received at least one study product, had one efficacy assessment and did not have any protocol violations deemed to affect efficacy. Missing values were not imputed.||%SMHR||Standard Error|Mean
675310|NCT01641159|Secondary|Cocaine-use Days|Cocaine use days during days 22-105 as assessed by UDS and self-report combined with no imputation|study week 16|All randomized participants||proportion of cocaine use days|||Number
675311|NCT01641159|Primary|Maximum Days of Continuous Cocaine Abstinence|The primary outcome measure selected for the present two-stage protocol is the maximum days of continuous cocaine abstinence during study weeks 4-15. The Timeline Follow-back (TLFB) procedure (Sobell and Sobell, 1992; Fals-Stewart, 2000) will be used to assess the participants' self-reported use of substances for each day of the study. A rapid UDS system that screens for drugs of abuse will be used to analyze the urine samples.|study week 16|||Days||Standard Deviation|Mean
675322|NCT01641133|Primary|Number of Subjects With Grade 3 Adverse Events (AEs) (Solicited and Unsolicited)|The number of subjects with Grade 3 AEs (solicited and unsolicited), during the 31-day post-vaccination period following each primary dose is reported.|Within 31-day (Day 0-Day 30) after any dose of primary vaccination|The analysis was performed on the Total Vaccinated cohort for Primary Epoch, which included all subjects with at least one primary vaccine dose administration documented and the symptom sheet filled in.||Subjects|||Number
675312|NCT01641133|Secondary|Concentrations of Antibodies Against Protein D (Anti-PD)|Anti-PD antibody concentrations were measured by Enzyme-linked Immunosorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The cut-off of the assay was an anti-PD antibody concentration higher than or equal to (≥) 153 EL.U/mL.|At study Month 3 (one month after primary vaccination) and at study Month 11 (one month after booster vaccination)|The analysis was performed on the ATP cohort for immunogenicity adapted for each epoch, which included all evaluable subjects for whom data concerning primary or booster immunogenicity outcome measures were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
675313|NCT01641133|Secondary|Antibody Concentrations Against Pneumococcal Serotypes|Antibodies assessed for this outcome measure were those against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F-inhibition enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL.|At study Month 3 (one month after the primary vaccination), at study Month 10 (prior to booster vaccination) and at study Month 11 (one month after the booster vaccination)|The analysis was performed on the ATP cohort for immunogenicity adapted for each epoch, which included included all evaluable subjects for whom data concerning primary or booster immunogenicity outcome measures were available.||µg/mL||95% Confidence Interval|Geometric Mean
675314|NCT01641133|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From first vaccination (Month 0) up to study end (11-14 months)|The analysis was performed on the Total Vaccinated cohort for Primary Epoch, which included all subjects with at least one primary vaccine dose administration documented.||Subjects|||Number
675315|NCT01641133|Secondary|Number of Subjects With Unsolicited AEs|An unsolicited AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. “Any” is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.|During the 31-day (Days 0-30) post-booster vaccination period|The analysis was performed on the Total Vaccinated cohort for Booster Epoch, which included all subjects with booster vaccine administration documented and the symptom sheet filled in.||Subjects|||Number
675316|NCT01641133|Secondary|Number of Subjects With Unsolicited AEs|An unsolicited AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. “Any” is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.|During the 31-day (Days 0-30) post-primary vaccination period|The analysis was performed on the Total Vaccinated cohort for Primary Epoch, which included all subjects with at least one primary vaccine dose administration documented.||Subjects|||Number
675317|NCT01641133|Secondary|Number of Subjects Reporting Any and Grade 3 Symptoms (Solicited and Unsolicited)|The number of subjects with any and grade 3 symptoms (solicited and unsolicited), during the 31-day post-booster vaccination period is reported.|During the 31-day (Days 0-30) post-booster vaccination period|The analysis was performed on the Total Vaccinated cohort for Booster Epoch, which included all subjects with booster vaccine administration documented and the symptom sheet filled in.||Subjects|||Number
675318|NCT01641133|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms assessed include drowsiness, fever (defined as axillary temperature ≥ 37.5°C), irritability, and loss of appetite. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (axillary temperature) above (>) 39.5 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all. “Any” is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination.|During the 4-day (Days 0-3) post-booster vaccination period|The analysis was performed on the Total Vaccinated cohort for Booster Epoch, which included all subjects with booster vaccine administration documented and the symptom sheet filled in.||Subjects|||Number
675319|NCT01641133|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms assessed include drowsiness, fever (defined as axillary temperature ≥ 37.5°C), irritability, and loss of appetite. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (axillary temperature) above (>) 39.5 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all. “Any” is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination.|During the 4-day (Days 0-3) post-vaccination period following each primary dose|The analysis was performed on The Total Vaccinated cohort for Primary Epoch, which included all subjects with at least one primary vaccine dose administration documented and the symptom sheet filled in.||Subjects|||Number
675320|NCT01641133|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (>) 30 millimeters (mm). “Any” is defined as incidence of the specified symptom regardless of intensity.|During the 4-day (Days 0-3) post-booster vaccination period|The analysis was performed on the Total Vaccinated cohort for Booster Epoch, which included all subjects with booster vaccine administration documented and the symptom sheet filled in.||Subjects|||Number
675321|NCT01641133|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (>) 30 millimeters (mm). “Any” is defined as incidence of the specified symptom regardless of intensity.|During the 4-day (Days 0-3) post-vaccination period following each primary dose|The analysis was performed on The Total Vaccinated cohort for Primary Epoch, which included all subjects with at least one primary vaccine dose administration documented and the symptom sheet filled in.||Subjects|||Number
675323|NCT01641120|Secondary|Perception of Needle|"Secondary endpoint was assessment of the perception of the needle based on patient questionnaires completed after each injection. The patient will respond to each statement on a scale which ranges from 1 (strongly agree) to 5 (strongly disagree).
A total of 6 statements were given to the participant the more strongly the participant agreed with the statement, the more favorably they perceived the needle.
Data from Weeks 2 and 3 were combined and averaged to obtain a single value as both weeks a 30 gauge needle was used for injection. Mean describes perception of the 30 gauge needle.
Data from Weeks 4 and 5 were combined and averaged to obtain a single value as both weeks a 25 gauge needle was used for injection. Mean describes perception of the 25 gauge needle."|Weeks 2, 3, 4, 5|||units on a scale||Standard Deviation|Mean
675324|NCT01641120|Primary|Visual Analog Scale Score for Post-injection Pain|"The primary endpoint of the study was a change in patient self-reported 100 mm (10 cm) Visual Analogue Scale (VAS) score for post-injection pain.VAS scale (min=0 - max=100 mm (10 cm)) 0= no pain; 100 mm (10 cm)=very severe pain.
Data from Weeks 2 and 3 were combined and averaged to obtain a single value as both weeks a 30 gauge needle was used for injection. The 30 gauge needle VAS mean refers to the mean for post-injection pain for that needle size.
Data from Weeks 4 and 5 were combined and averaged to obtain a single value as both weeks a 25 gauge needle was used for injection. The 25 gauge needle VAS mean refers to the mean for post-injection pain for that needle size."|Weeks 2, 3, 4, 5|||cm||Standard Deviation|Mean
675325|NCT01641120|Secondary|Fear of Injection|"Secondary endpoint was assessment of fear of injection based on patient questionnaires completed prior to each injection. The patient will respond to each statement on a scale which ranges from 1 (almost always) to 4 (almost never).
Data from Weeks 2 and 3 were combined and averaged to obtain a single value as both weeks a 30 gauge needle was used for injection. Mean describes fear of injection for the 30 gauge needle.
Data from Weeks 4 and 5 were combined and averaged to obtain a single value as both weeks a 25 gauge needle was used for injection. Mean describes fear of injection for the 25 gauge needle."|Weeks 2, 3, 4, 5|||units on a scale||Standard Deviation|Mean
675326|NCT01641120|Primary|Change in Patient Visual Analog Scale Score for Pre-injection Anxiety|"The primary endpoint of the study was a change in patient self-reported 100 mm (10 cm) Visual Analogue Scale (VAS) score for pre-injection anxiety. VAS scale (min=0- max=100 mm (10cm)) 0= no anxiety; 100 mm (10 cm)=very severe anxiety.
Data from Weeks 2 and 3 were combined and averaged to obtain a single value as both weeks a 30 gauge needle was used for injection. The 30 gauge needle VAS mean refers to the mean for pre-injection anxiety for that needle size.
Data from Weeks 4 and 5 were combined and averaged to obtain a single value as both weeks a 25 gauge needle was used for injection. The 25 gauge needle VAS mean refers to the mean for pre-injection anxiety for that needle size."|Weeks 2, 3, 4, 5|||cm||Standard Deviation|Mean
675327|NCT01641081|Secondary|Change From Baseline in Normalized FEV1 AUC0-6 After the Morning Dose (Day 1)|AUC0-6 is area under the curve from time 0 to 6 hours Serial spirometry was performed at -60 min predose, at 5 (+5) and 30 (±5) min post-dose, and at 1, 2, 3, 4, and 6 hrs post-dose (±15 min) Change from baseline was baseline of Period 1 The time-normalized FEV1 AUC0-6 was calculated by means of the trapezoidal method, dividing the area under the curve by the corresponding time intervals|Baseline and up to 6 hrs post-dose (±15 min) on Day 1 of treatment|Intent to treat (ITT) Population defined as all patients in the Safety Population who had a baseline and at least 1 post-baseline FEV1 assessment||Liters||Standard Error|Least Squares Mean
675328|NCT01641081|Primary|Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) AUC0-6 After the Morning Dose (Day 14)|AUC0-6 is area under the curve from time 0 to 6 hours Serial spirometry was performed at -60 min predose, at 5 (+5) and 30 (±5) min post-dose, and at 1, 2, 3, 4, and 6 hrs post-dose (±15 min) Change from baseline was baseline of each treatment period The normalized FEV1 AUC0-6 was calculated by means of the trapezoidal method, dividing the area under the curve by the corresponding time intervals|Baseline and up to 6 hrs post-dose (±15 min) on Day 14 of treatment|Intent to treat (ITT) Population defined as all patients in the Safety Population who had a baseline and at least 1 post-baseline FEV1 assessment||Liters||Standard Error|Least Squares Mean
675329|NCT01640964|Secondary|Number of Patients With Total Adverse Events, Serious Adverse and Death as Assessment of Safety and Tolerability of Serelaxin|This endpoint reports patients with any adverse event, serious adverse event and death for the serelaxin group of Part A and Part B of the study.|4 weeks|Safety assessment happened on full analysis set which included all patients who received any amount of study treatment during the treatment period and had at least one post-Baseline assessment during that period.||Patients|||Number
675330|NCT01640964|Secondary|Change From Baseline of the Portal Vein Pressure (PVP) (Study Part B)|Portal vein pressure was measured at 15 min intervals (i.e. prior to and at 15, 30, 45, 60, 75, 90, 105, and 120 min of serelaxin infusion).|Baseline, 120 min post infusion|For Part B of the study, full analysis set included all patients who received any amount of study treatment during the treatment period and had at least one post-baseline assessment during that period. Only patients with a value at both baseline and this time point are included.||mmHg||95% Confidence Interval|Mean
675331|NCT01640964|Secondary|Change From Baseline of the Blood Flow for the Portal Vein (Study Part A (Serelaxin Treatment Group Only))|"A non-contrast magnetic resonance angiography (MRA) sequence was performed to acquire phase contrast blood flow measurements from vessels of interest such as the portal vein. The flow is the average flow over the cardiac cycle.
Baseline blood flow measurements are measured at pre-dose (Day 1, 0 min post-treatment)."|Baseline, 120 min post-infusion|For the part A of the study, full analysis set included all patients who received any amount of study treatment during the treatment period and had at least one post-baseline assessment during that period. Only patients with a value at both baseline and at the time point are included||L/min||95% Confidence Interval|Mean
675332|NCT01640964|Secondary|Change From Baseline of the Blood Flow for the Descending Thoracic Aorta (Study Part A (Serelaxin Treatment Group Only))|"A non-contrast magnetic resonance angiography (MRA) sequence was performed to acquire phase contrast blood flow measurements from vessels of interest such as descending thoracic aorta. The flow is the average flow over the cardiac cycle.
Baseline blood flow measurements are measured at pre-dose (Day 1, 0 min post-treatment)."|Baseline, 120 min post-infusion|For the part A of the study, full analysis set included all patients who received any amount of study treatment during the treatment period and had at least one post-baseline assessment during that period. Only patients with a value at both baseline and at the time point are included||L/min||95% Confidence Interval|Mean
675333|NCT01640964|Secondary|Change From Baseline of the Blood Flow for the Superior Mesenteric Artery (Study Part A (Serelaxin Treatment Group Only))|"A non-contrast magnetic resonance angiography (MRA) sequence was performed to acquire phase contrast blood flow measurements from vessels of interest such as superior mesenteric artery. The flow is the average flow over the cardiac cycle.
Baseline blood flow measurements are measured at pre-dose (Day 1, 0 min post-treatment)."|Baseline, 120 min post-infusion|For the part A of the study, full analysis set included all patients who received any amount of study treatment during the treatment period and had at least one post-baseline assessment during that period. Only patients with a value at both baseline and at the time point are included||L/min||95% Confidence Interval|Mean
675334|NCT01640964|Secondary|Change From Baseline of the Blood Flow for the Hepatic Artery (Study Part A (Serelaxin Treatment Group Only))|"A non-contrast magnetic resonance angiography (MRA) sequence was performed to acquire phase contrast blood flow measurements from vessels of interest such as hepatic artery. The flow is the average flow over the cardiac cycle.
Baseline blood flow measurements are measured at pre-dose (Day 1, 0 min post-treatment)."|Baseline, 120 min post-infusion|For the part A of the study, full analysis set included all patients who received any amount of study treatment during the treatment period and had at least one post-baseline assessment during that period. Only patients with a value at both baseline and at the time point are included||L/min||95% Confidence Interval|Mean
675335|NCT01640964|Secondary|Change From Baseline of the Blood Flow for the Total Renal Arteries (Study Part A (Terlipressin Acetate Group Only))|The flow is the average flow over the cardiac cycle. Total renal artery flow = left renal artery flow + right renal artery flow. These measurements were collected through magnetic resonance angiography (MRA) scans. Baseline blood flow for total renal artery is measured at pre-dose (Day 1, 0 min post-treatment)|Baseline, 120 min post infusion|Full analysis set (FAS) included all patients who received any amount of study treatment during the treatment period and had at least one post-Baseline assessment during that period.||L/min||95% Confidence Interval|Mean
675336|NCT01640964|Primary|Change From Baseline of the Portal Pressure Gradient (PPG) (Study Part B)|"Direct venous pressure was measured by portal pressure gradient (PPG). PPG = portal vein pressure (PVP) - inferior vena cava pressure (IVCP).
Baseline blood flow for PPG was measured at pre-dose (Day 1, 0 min post-treatment). PVP was measured at 15 min intervals (i.e. prior to and at 15, 30, 45, 60, 75, 90, 105, and 120 min of serelaxin infusion)."|Baseline, 120 min post-infusion start|For Part B of the study, full analysis set included all patients who received any amount of study treatment during the treatment period and had at least one post-baseline assessment during that period.Only patients with a value at both baseline and this time point are included.||mmHg||95% Confidence Interval|Mean
675337|NCT01640964|Primary|Change From Baseline of the Blood Flow for the Total Renal Arteries (Study Part A (Serelaxin Treatment Group Only))|The flow is the average flow over the cardiac cycle. Total renal artery flow = left renal artery flow + right renal artery flow. These measurements were collected through magnetic resonance angiography (MRA) scans. Baseline blood flow for total renal artery is measured at pre-dose (Day 1, 0 min post-treatment)|Baseline, 120 min post serelaxin infusion|Full analysis set (FAS) included all patients who received any amount of study treatment during the treatment period and had at least one post-Baseline assessment during that period.||L/min||95% Confidence Interval|Mean
675338|NCT01640925|Secondary|Number of Patients With In-hospital Mortality||up to 28 days or until first hospital discharge||||||
675339|NCT01640925|Secondary|ICU Length of Stay in Days|Number of days in the ICU after enrollment in study until first ICU discharge.|up to 28 days||||||
675340|NCT01640925|Secondary|Blood Culture Contamination Rate||up to 28 days||||||
675341|NCT01640925|Secondary|Incidence of Skin Irritation|The incidence of new onset skin irritation will be recorded and graded for severity using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.03.|up to 28 days||||||
675342|NCT01640925|Primary|Incidence of Nosocomial Infection|"Proportion of patients with one or more incident nosocomial infections.
Primary Efficacy Endpoints* (Composite of new nosocomial infection)
Primary Bloodstream Infection
Catheter Related Urinary Tract Infection
Ventilator-Associated Pneumonia**
Surgical Site Infection
(*)Diagnosed using the Centers for Disease Control criteria for hospital acquired infections. Only infections that develop 48 hours or more after study enrollment will be counted as primary endpoints.
(**)Ventilator associated pneumonia is defined as pneumonia that developed after 48 hours of mechanical ventilation."|Up to 28 days|||participants|||Number
675343|NCT01640548|Secondary|Duration of Treatment of bDMARD Administered With Concomitant Traditional DMARD as Previous Treatment for RA||9 months|"Included participants who were treated with a bDMARD with concomitant traditional DMARD as previous treatment for RA. n is the number of participants who received particular bDMARD as previous RA treatment."||months||Full Range|Median
675344|NCT01640548|Secondary|Duration of Treatment With bDMARDs in Monotherapy as Previous Treatment for RA||9 months|"Included participants treated with a bDMARD monotherapy as previous treatment for RA prior to switch to current bDMARD monotherapy. n is the number of participants who received particular bDMARD as previous RA treatment."||months||Full Range|Median
675345|NCT01640548|Secondary|Duration of Treatment With the Current bDMARD Usage in Monotherapy||9 months|"Included all participants who received bDMARD monotherapy as their current treatment for RA. n is the number of participants who received that particular bDMARD as their current RA treatment."||months||Full Range|Median
675346|NCT01640548|Primary|Percentage of Participants by Reason for Choosing Previous and Current bDMARDs in Monotherapy|Both previous and current bDMARDs were presented together for each subgroup, therefore the percentage of participants under each reason did not add up to 100%.|9 months|Included all participants who entered the retrospective chart review.||percentage of participants||95% Confidence Interval|Number
675347|NCT01640548|Secondary|Total Number of Tender Joints and Swollen Joints and Non-Evaluable DAS 28 Joints When Assessed Using Both ESR and CRP Methods|DAS28 was calculated from the tender joint count (TJC) of 28 joints, swollen joint count (SJC) of 28 joints, ESR (in millimeters/hour) or CRP (in milligrams/liter), and the participant's global assessment of disease activity (visual analog scale: 0=no disease activity to 100=maximum disease activity). TJC and SJC assessed as part of the DAS28 outcome measure assessment were reported.|9 months|"Includes all participants who were evaluable for this outcome. n represents the number of participants who were evaluable for that particular assessment."||joints count||95% Confidence Interval|Mean
675348|NCT01640548|Primary|Percentage of Participants With Concomitant Treatment Other Than DMARDs for RA by Type of Treatment|All corticosteroids and non-steroidal anti-inflammatory drugs taken as previous and current treatments for RA were coded according to the Roche international non-proprietary name dictionary.|9 months|Included all the participants who entered the retrospective chart review.||percentage of participants|||Number
675349|NCT01640548|Secondary|Assessment of Disease Activity Score of 28 Joint Count (DAS28) by Either Erythrocyte Sedimentation Ratio (ESR) or C-Reactive Protein (CRP)|DAS28 was calculated from the tender joint count (TJC) of 28 joints, swollen joint count (SJC) of 28 joints, ESR (in millimeters/hour) or CRP (in milligrams/liter), and the participant's global assessment of disease activity (visual analog scale: 0=no disease activity to 100=maximum disease activity). The formula for calculating DAS28 score using ESR value is: 0.56 x square root (√) of TJC + 0.28 x √(SJC) + 0.70 x log natural (ESR) + 0.014 x global assessment of RA score. The formula for calculating DAS28 score using CRP value is: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.36 x log natural (CRP+1) + 0.014 x global assessment of RA score +0.96. The DAS28 score range was 0-9.4 where higher scores represented higher disease activity.|9 months|"Included the number of participants who were evaluable for DAS28 assessment. n represents the number of participants who were evaluable for that particular assessment."||scores on a scale||95% Confidence Interval|Mean
675350|NCT01640548|Primary|Percentage of Participants With bDMARD Monotherapy as Previous RA Treatment at Anytime Prior to Switch to bDMARD Monotherapy|bDMARDS for RA treatment include etanercept, adalimumab, tocilizumab, rituximab, certolizumab pegol, infliximab, golimumab, abatacept and anakinra medications. Only the most frequently used (> 10% of participants) bDMARDs in monotherapy as previous treatment for RA were reported. If a participant was recorded to have been treated with a single bDMARD more than once, the participant was counted only once per type of bDMARD. If participant received 2 different types of bDMARDs as part of their previous treatment, the participant was counted twice, once per each type of bDMARD; therefore, the percentage of participants did not add up to 100%.|9 months|Included participants who received bDMARD as monotherapy as previous treatment prior to switch to bDMARD monotherapy as current treatment.||percentage of participants|||Number
675351|NCT01640548|Primary|Percentage of Participants With bDMARD and Concomitant Traditional DMARD Regimen as Previous RA Treatment at Anytime Prior to Switch to bDMARD Monotherapy by Type of bDMARD|bDMARDS for RA treatment include etanercept, adalimumab, tocilizumab, rituximab, certolizumab pegol, infliximab, golimumab, abatacept and anakinra medications. Only the most frequently used (> 10% of participants) bDMARDs with concomitant traditional DMARD as previous treatment for RA were reported. If a participant was recorded to have been treated with a single bDMARD more than once, the participant was counted only once per type of bDMARD. If participant received 2 different types of bDMARDs as part of their previous treatment, the participant was counted twice, once per each type of bDMARD; therefore, the percentage of participants did not add up to 100%.|9 months|Included participants who were previously treated with any bDMARD with concomitant traditional DMARD prior to switch to bDMARD monotherapy as current RA treatment.||percentage of participants|||Number
675352|NCT01640548|Primary|Percentage of Participants Treated With Traditional DMARDs as Their Previous Treatment for RA by Type of DMARD|Traditional DMARDS for RA treatment include methotrexate, sulfasalazine, leflunomide, hydroxychloroquine, gold compounds, penicillamine, cyclosporine, azathioprine, chlorambucil, mercaptopurine, and mycophenolate mofetil medications. Previous RA treatment included all the treatments received prior to switching to current RA treatment.|9 months|Included all the participants who took any past traditional DMARDs.||percentage of participants|||Number
675353|NCT01640548|Primary|Percentage (%) of Participants Receiving Biologic Disease Modifying Anti-Rheumatic Drugs (bDMARDs) in Monotherapy as Current Treatment for RA According to National Institute for Health and Clinical Excellence (NICE) Guidelines by Type of bDMARD|bDMARDS for RA treatment include etanercept, adalimumab, tocilizumab, rituximab, certolizumab pegol, infliximab, golimumab, abatacept and anakinra medications. Current bDMARDs were defined as those with a start date on or after the date of collection, or those with a start date before the date of collection and an end date on or after the date of collection. NICE guidelines recommend the participants with severe active RA who inadequately responded to prior DMARD treatment (trial of 2 DMARDs, one which includes methotrexate) and were intolerant to methotrexate or the treatment with methotrexate considered inappropriate be treated with a biologic DMARD monotherapy.|9 months|Included all the participants who entered the retrospective chart review.||percentage of participants|||Number
675354|NCT01640353|Secondary|Serious Adverse Events|Occurrence of adverse events meeting the ISO14155:2011 definition of serious occurring during the procedure, at the time of hospital discharge (typically day of or next day after procedure), and at various times in late follow-up.|Procedure, discharge, 1,3,6,12,18 and 24 months|149 participants had 24 months of follow up post-operatively.||serious adverse event|||Number
675355|NCT01640353|Secondary|Work Status|Proportion of non-working subjects who return to work|Basline, 24 months|Participants with work status data at 24 months post-operatively who were not working due to back pain (at baseline 37.4% were not working due to back pain).||percentage of participants|||Number
675356|NCT01640353|Secondary|Ambulatory Status|Percentage of population fully ambulatory at 24 months post operatively.|24 months|148 participants had ambulatory status at 24 month post-operatively||percentage of participants|||Number
675357|NCT01640353|Secondary|Change in Quality of Life|Change in QOL as measured by Short Form-36 PCS and EQ-5D at post-operative visits|Baseline and 24 months|148 participants had QOL information at 24 months post-operatively.||units on a scale||Standard Deviation|Mean
675358|NCT01640353|Secondary|Change in Back Dysfunction|Oswestry Disability Index is a validated patient questionnaire aiming to assess low back pain. The computed scores can be 0% to 100%. Lower scores indicate low disability while high scores indicate high disability. There are 10 questions on the questionnaire. Each has 6 possible answers (0 points - 5 points). If the question is skipped, it's points are subtracted from the denominator. If the raw score is 30 and all 10 questions were answered, the calculation would be 30 / 50 = 60%. If one question was skipped, it would be 30 / 45 = 67%.|24 months|147 of participants had ODI at 24 months post-operatively.||units on a scale||Standard Deviation|Mean
675359|NCT01640353|Secondary|Change in SI Joint Pain on Visual Analog Scale (VAS) (0-100 mm)|The Visual Analog Scale (VAS) is a 100 mm line on which the subject indicates their level of pain. 0 = no pain. 100 = worst imaginable pain.|24 months|148 subjects had SIJ pain scores at 24 months.||units on a scale||Standard Deviation|Mean
675360|NCT01640353|Primary|Subject Success|Composite endpoint of reduction from baseline in VAS back pain score by at least 20 mm, lack of device-related serious adverse events, absence of neurologic worsening and absence of surgical re-intervention.|Baseline and 6 months|Of 194 subjects who were eligible and signed informed consent, 10 voluntarily withdrew prior to SIJF. All data from 12 subjects at a single center were excluded due to early termination of the site. 172 subjects were treated. 168 had 6 months of follow up.||percentage of participants||95% Confidence Interval|Number
675361|NCT01640340|Secondary|Percentage of Patients Who Experienced Grade 1, 2 or 3 Vomiting From Time 0 to 120 Hours|The percentage of patients who experienced grade 1, 2 or 3 vomiting from time 0 to 120 hours. Nausea graded using the National Cancer Institute (NCI) CTCAE v 4.0 vomiting Grading Scale. Grade 1=Loss of appetite without alteration in eating habits, Grade 2= Oral intake decreased without significant weight loss, dehydration or malnutrition, Grade 3= Inadequate oral caloric or fluid intake; tube feeding, TPN, or hospitalization indicated.|From time 0 to 120 hours|||percentage of participants|||Number
675362|NCT01640340|Secondary|Use of Rescue Medication for Each Treatment Arm||From time 0 to 120 hours|||percentage of participants|||Number
675363|NCT01640340|Secondary|Visual Analog Scale (VAS) Scores||Up to 7 days after completion of study treatment|VAS Scores were not collected|||||
675364|NCT01640340|Secondary|Percentage of Patients Who Experienced Grade 1, 2 or 3 Nausea From Time 0 to 120 Hours|The percentage of patients who experienced grade 1, 2 or 3 nausea from time 0 to 120 hours. Nausea graded using the National Cancer Institute (NCI) CTCAE (Common Toxicity Criteria for Adverse Effects)version 4.0 Nausea Grading Scale. Grade 1=Loss of appetite without alteration in eating habits, Grade 2= Oral intake decreased without significant weight loss, dehydration or malnutrition, Grade 3= Inadequate oral caloric or fluid intake; tube feeding, TPN, or hospitalization indicated.|Time 0 to 120 hours|||percentage of participants|||Number
675365|NCT01640340|Secondary|Delayed CR (Complete Response)|After the First Course of HEC, Defined as no Emesis and no Use of Rescue Medication From Time 24to 120 Hours.|24-120 hours after chemotherapy|||percentage of participants|||Number
675366|NCT01640340|Secondary|Acute CR (Complete Response)|After the First Course of HEC, Defined as no Emesis and no Use of Rescue Medication from time 0 to 24 hours.|0-24 hours after chemotherapy|||percentage of particpants|||Number
675367|NCT01640340|Primary|Overall CR(Complete Response)After the First Course of HEC, Defined as no Emesis and no Use of Rescue Medication|We will use exact binomial methods to estimate proportions and their associated 95% confidence intervals.|Up to 120 hours after completion of chemotherapy|||percentage of patients||95% Confidence Interval|Number
675368|NCT01640327|Secondary|Numbers of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 – Day 4 Postvaccination)|Safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 up to and including day 4 after the TIVf vaccination.|From day 1 through day 4 postvaccination|Analysis was done on the safety dataset i.e. the subjects in the exposed population who provided postvaccination safety data.||Subjects|||Number
675369|NCT01640327|Primary|Percentage of Subjects Who Achieved HI Titer ≥40 Against Each of Three Vaccine Strains After One Vaccination of TIVf|"Immunogenicity was measured as the percentage of subjects achieving HI titer ≥40 against each of three vaccine strains at baseline (day 1) and three weeks after TIVf vaccination (day 22).
This criterion was met according to CHMP guideline if percentage of subjects achieving HI titer ≥40 is >70% (≥18 years to ≤60) or >60% (≥61 years)."|Day 1 and 22|Analysis was done on the PP set.||Percentages of Subjects||95% Confidence Interval|Number
675370|NCT01640327|Primary|Geometric Mean Ratio of Subjects Against Each of Three Vaccine Strains After One Vaccination of TIVf|"Geometric mean ratio (GMR) of subjects was calculated as the ratio of postvaccination to prevaccination HI geometric mean titers (GMTs), directed against each of three vaccine strains, three weeks after vaccination (day 22).
The CHMP criterion was met if the geometric mean increase (GMR, day 22/day 1) in HI antibody titer was >2.5 (≥18 years to ≤60 years) or >2.0 (≥61 years)."|Day 22|Analysis was done on the PP set.||Ratio||95% Confidence Interval|Number
675371|NCT01640327|Primary|Percentage of Subjects With Seroconversion or Significant Increase in HI Titer Against Each of Three Vaccine Strains After One Vaccination of TIVf|"Immunogenicity was measured as the percentage of subjects who achieved seroconversion or significant increase in hemagglutination inhibition (HI) titer, against each of three vaccine strains, three weeks after vaccination (day 22), evaluated using HI antigen assay.
As per the European (CHMP) criteria seroconversion or significant increase in titer was defined as the percentage of subjects with a prevaccination HI titer <10 to a postvaccination HI titer ≥40; or in subjects with a prevaccination HI titer ≥10, a ≥4-fold increase in postvaccination HI antibody titer.
This criterion was met according to CHMP guideline if percentage of subjects achieving seroconversion or significant increase in HI titer is >40% (≥18 years to ≤60 years) or >30% (≥61 years)."|Day 22|Analysis was done on the per-protocol (PP) set, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis.||Percentages of Subjects||95% Confidence Interval|Number
675372|NCT01640314|Secondary|Number of Subjects Reporting Unsolicited Adverse Events After Receiving One Dose of TIVc.|The number of subjects in both age groups reporting any unsolicited AEs between Day 1 to Day 22 after receiving one dose of TIVc.|Day 1 to Day 22|Analysis was done on the safety set population.||Number of Subjects|||Number
675373|NCT01640314|Secondary|Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 – Day 4 Postvaccination)|Safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 up to and including day 4 after TIVc vaccination.|From day 1 through day 4 postvaccination|Analysis was done on the safety dataset i.e. the subjects in the exposed population who provided postvaccination safety data.||Number of subjects|||Number
675374|NCT01640314|Primary|Percentages of Subjects Who Achieved HI Titer ≥40 Against Each of Three Vaccine Strains After One Vaccination of TIVc|"Immunogenicity was measured as the percentage of subjects achieving HI titer ≥40 against each of three vaccine strains at baseline (day 1) and three weeks after TIVc vaccination (day 22).
This criterion was met according to CHMP guideline if percentage of subjects achieving HI titer ≥40 is >70% (≥18 years to ≤60) or 60% (≥61 years)."|Day 1 and 22|Analysis was done on the PP set.||Percentages||95% Confidence Interval|Number
676306|NCT01627002|Primary|Assessment of the Effect of PA401 on Induced Sputum Total Neutrophils|Induced sputum was collected 6 hours after lipopolysaccharide challenge (5.5 hours following dosing) and assessed for neutrophils|5.5 hours post dose|||x10e6 cells/g||95% Confidence Interval|Least Squares Mean
675375|NCT01640314|Primary|Geometric Mean Ratio of Subjects Against Each of Three Vaccine Strains After One Vaccination of TIVc|"Geometric mean ratio (GMR) of subjects was calculated as the ratio of postvaccination to prevaccination HI geometric mean titers (GMTs), directed against each of three vaccine strains, three weeks after vaccination (day 22).
The CHMP criterion was met if the geometric mean increase (GMR, day 22/day 1) in HI antibody titer is >2.5 (≥18 years to ≤60 years) or >2.0 (≥61 years)."|Day 22|Analysis was done on the PP set.||Ratio||95% Confidence Interval|Number
675376|NCT01640314|Primary|Percentages of Subjects With Seroconversion or Significant Increase in HI Titer Against Each of Three Vaccine Strains After One Vaccination of TIVc|"Immunogenicity was measured as the percentage of subjects who achieved seroconversion or significant increase in hemagglutination inhibition (HI) titer, against each of three vaccine strains, three weeks after vaccination (day 22), evaluated using HI cell-derived antigen assay.
As per the European (CHMP) criteria, seroconversion or significant increase in titer is defined as the percentage of subjects with a prevaccination HI titer <10 to a postvaccination HI titer ≥40; or in subjects with a prevaccination HI titer ≥10, a ≥4-fold increase in postvaccination HI antibody titer. This criterion is met according to CHMP guideline if percentage of subjects achieving seroconversion or significant increase in HI titer is >40% (≥18 years to ≤60 years) or 30% (≥61 years)."|Day 22|Analysis was done on the per-protocol (PP) set, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis.||Percentages||95% Confidence Interval|Number
675377|NCT01640197|Secondary|Number of Participants With Significant Modulation of CBF in MCA|CBF was assessed in the middle cerebral artery (MCA) with Trans-cranial doppler via a trans- temporal acoustic window. Participants were deemed to have significant modulation of CBF in the MCA if readings differed significantly from those obtained on day 1 (baseline).|28 days|All participants who were part of the TCD component, who could provide a consistent blood flow trace, were included in the analysis.||Participants|||Number
675378|NCT01640197|Secondary|Number of Participants With Significant Modulation of Blood Pressure|Participants were deemed to have significant modulation of blood pressure if their readings on day 28 differed significantly from that taken on day 1 (baseline).|28 days|All participants who provided all BP readings across the study were included in the analysis.||Participants|||Number
675379|NCT01640197|Secondary|Number of Participants With Significant Modulation of Health|Subjective perceptions of health were assessed with the General Health Questionnaire. Participants were deemed to have significant modulation of health if scores on Week 1, Week 2, Week 3 and/or Week 4 differed significantly from day 1 (baseline) completion.|Day 28|Participants were included in the analysis if they had completed questionnaires correctly.||Participants|||Number
675380|NCT01640197|Secondary|Number of Participants With Significant Modulation of Sleep|Subjective perception of sleep quality was assessed with the PSQI. Participants were deemed to have significant modulation of sleep if scores on Week 1, Week 2, Week 3 and/or Week 4 differed significantly from those on day 1 (baseline).|Day 28|All participants who completed their questionnaires correctly were included in the analysis.||Participants|||Number
675381|NCT01640197|Secondary|Number of Participants With Modulated Cognitive Performance|Cognitive performance was assessed by a range of cognitively demanding tasks on day 28 of the supplementation period. Participants were deemed to have significant modulation of cognitive performance if their scores on these tasks were significantly different from scores taken on day 1.|28 days|All participants who properly completed all repetitions of all tasks on both days were included in the analysis.||Participants|||Number
675382|NCT01640197|Secondary|Number of Participants With Modulated Mood|Subjective mood was assessed with the Profile of mood states (POMS) questionnaire every 7 days during the 28- day period. Participants were deemed to have significant modulation of mood if their scores on week 1, week 2, week 3 and/or week 4 differed significantly from scores on the baseline questionnaire completed on day 1.|28 days|Participants were included in the final analysis if they had completed all questionnaires correctly.||Participants|||Number
675383|NCT01640197|Primary|Chronic Modulation of Cerebral Blood Flow|Cerebral blood flow (CBF) was measured in the frontal cortex with Near-Infrared Spectroscopy (NIRS). Modulation was deemed to have taken place if levels differed significantly from day 1 to day 28.|40- 80 minutes post- dose on day 28 of supplementation|Participants were included in the analysis if they provided full NIRS readings on session 1 and session 2.||Participants|||Number
675384|NCT01640184|Secondary|Changes of Blood Levels on Bone Specific Alkaline Phosphatase.|The blood levels of bone specific alkaline phosphatase will be detected at least once every 3 months and will be compared to the baseline levels.|Baseline and 12 months|||microgram/L||Standard Deviation|Mean
675385|NCT01640184|Secondary|Changes of Blood Levels on iPTH During 12 Months.|The blood levels of iPTH will be detected at least once every 3 months and will be compared to the baseline levels.|Baseline and 12 months|||ng/ml||Standard Deviation|Mean
675386|NCT01640184|Secondary|Changes of Blood Levels on Phosphorus During 12 Months.|The blood levels of phosphorus will be detected at least once every 3 months and will be compared to the baseline levels.|Baseline and 12 months|||mmol/L||Standard Deviation|Mean
675387|NCT01640184|Secondary|Changes of the Blood Levels on Calcium During 12 Months.|The blood levels of calcium will be detected at least once every 3 months and will be compared to the baseline levels.|Baseline and 12 months|||mmol/L||Standard Deviation|Mean
675388|NCT01640184|Secondary|Incidence of Injury on the Recurrent Laryngeal Nerve (RLN).|Comparison of the incidence of RLN injury between ultrasonic ablation group and parathyroidectomy group.|12 months|||participants|||Number
675389|NCT01640184|Primary|Rate of Achieving the Target on Blood Intact Parathyroid Hormone Level According to Kidney Development Improvement Global Outcome (KDIGO) Guidelines.|The blood levels of intact parathyroid hormone (iPTH) will be detected every 3 months for stable patients. The blood test will be more frequent, at least once per-month, after the ultrasonic ablation treatment, surgery, or during the impulse therapy of active vitamin D with large doses.|12 months|Number of participants analyzed is the number of patients completed study.||percentage of participants|||Number
675390|NCT01640171|Secondary|Likert Like Pain Scale Number of Participants Who Said the Topical Eye Hurt Much More Than the Subconjunctival Eye at Time of Intravitreal Injection|The patient was asked to compare the two eyes in the way described in the study protocol on a five point scale. If one eye hurt a lot more or a little more than the other or if the two eyes were equal (neither hurt more than the other).|24 hours|total group||participants|||Number
675391|NCT01640171|Secondary|Number of Participatns With Level 10 Pain on Wong-Baker Pain Scale In Subconjunctival Eye At Time of Intravitreal Injection|Pain was rated on a 10 point standardized pain scale, zero was the least pain and 10 was the worst pain. The patient was questioned using a script and shown a pain scale as well as told how the pain scale worked. Then the patient gave the number that characterized their pain.|24 hours|All patients in the study||participants|||Number
675392|NCT01640171|Primary|Number of Participants Who Preferred Subconjunctival Anesthetic at the Third Follow-up Visit|Participants received anesthetic over several treatment visits. They were allowed to change there preference at each visit. The final outcome was the preference indicated at the third follow-up visit.|up to 6 months|||participants|||Number
675393|NCT01640054|Primary|Percentage of Patients Who Had at Least 1 Adverse Event in Any Category|AE = adverse event, IP = investigational product, PO = orally, QD = once daily, SAE = serious adverse event|Entry in extension to study termination (variable duration; maximum 52 weeks)|The full analysis set was the primary population for reporting efficacy and safety data, and comprised all patients who received at least 1 dose of investigational product.||Percentage of patients|||Number
675394|NCT01640054|Secondary|SF-36 Score Over Time|n/a = not applicable, PO = orally, QD = once daily, SF-36 = 36 item short form health survey|Every 12 weeks for one year then yearly until study end|Insufficient data were available for analysis due to sparse data collection and the early termination of the study.|||||
675395|NCT01640054|Secondary|HAQ-DI Score Over Time|HAQ-DI = health assessment questionnaire - disability index, n/a = not applicable, PO = orally, QD = once daily|Every 12 weeks for one year then every 24 weeks until study end|Insufficient data were available for analysis due to sparse data collection and the early termination of the study.|||||
675396|NCT01640054|Secondary|DAS28-CRP Score Over Time|CRP = C-reactive protein, DAS28 = disease activity score based on a 28 joint count, n/a = not applicable, PO = orally, QD = once daily|Every 12 weeks for one year then every 24 weeks until study end|Insufficient data were available for analysis due to sparse data collection and the early termination of the study.|||||
675397|NCT01640054|Secondary|Components of ACR Response Criteria Over Time|ACR = American College of Rheumatology, n/a = not applicable, PO = orally, QD = once daily|Every 12 weeks for one year then every 24 weeks until study end|Insufficient data were available for analysis due to sparse data collection and the early termination of the study.|||||
675398|NCT01639833|Secondary|Hemostasis at All Treated Bleeding Sites Within 3 Minutes|The proportion of subjects achieving hemostasis at all treated bleeding sites within 3 minutes of device application.|Day 0|The Per Protocol (PP) population was used for the primary analysis of the primary effectiveness endpoint for the non-inferiority test.||percentage of participants||95% Confidence Interval|Number
675399|NCT01639833|Primary|Time to Hemostasis (TTH)|Time to Hemostasis (TTH) at the target bleeding site (TBS) following treatment (Veriset™ Hemostatic Patch or Control).|Day 0|The Per Protocol (PP) population was used for the primary analysis of the primary effectiveness endpoint for the non-inferiority test.||minutes||95% Confidence Interval|Median
675400|NCT01639755|Secondary|Percentage of Participants With Local Complications|The percentage of participants experiencing local complications (in the area of the implant) is reported.|Interim analysis: 12 months|Full analysis population included all participants.||percentage of participants|||Number
675401|NCT01639755|Secondary|Percentage of Participants With Capsular Contracture Evaluated by Four-Grade Baker Scale|The investigator evaluated capsular contracture (lining of cells formed around the device as the body’s response to a foreign object) using the Four-Grade Baker scale where: Grade I= Breast is normally soft and looks natural, Grade II= Breast is a little firm but looks normal, Grade III=Breast is firm and looks abnormal or Grade IV= Breast is hard, painful, and looks abnormal. The percentage of participants in each Baker Grade is reported.|Interim analysis: 12 months|Participants from the Full Analysis population with data available for analysis.||percentage of participants|||Number
675402|NCT01639755|Secondary|Investigator Evaluation of Whether the Implant is Palpably Distinguishable From the Tissue|The investigator examined the breasts and evaluated whether the implant was palpably distinguishable from the tissue using a 5-point scale where 1=implant very easy to distinguish from the tissue to 5=implant indistinguishable from the tissue.|6 months|Full analysis population included all participants.||score on a scale||Standard Deviation|Mean
675403|NCT01639755|Secondary|Subject Satisfaction With Breasts Using the BREAST-Q Questionnaire|Participants evaluated satisfaction with their breasts using the BREAST-Q. Summary scores were computed by summing the score of each response and transferring them to a 0 (worst) to 100 (best) scale.|6 months|Full analysis population included all participants.||score on a scale||Standard Deviation|Mean
675404|NCT01639755|Primary|Investigator Overall Satisfaction With the Device Using a 5-Point Scale|The investigator evaluated the overall satisfaction with the device using a 5-point scale where 1=definitely dissatisfied with the device to 5=definitely satisfied with the device.|3 months|Full analysis population included all participants.||score on a scale||Standard Deviation|Mean
675405|NCT01639742|Secondary|Percentage of Participants With Local Complications|The percentage of participants experiencing local complications (in the area of the implant) is reported.|Interim analysis: 12 months|Full analysis population included all participants.||percentage of participants|||Number
675406|NCT01639742|Secondary|Percentage of Participants With Capsular Contracture Evaluated by Four-Grade Baker Scale|The investigator evaluated capsular contracture (lining of cells formed around the device as the body’s response to a foreign object) using the Four-Grade Baker scale where: Grade I= Breast is normally soft and looks natural, Grade II= Breast is a little firm but looks normal, Grade III=Breast is firm and looks abnormal or Grade IV= Breast is hard, painful, and looks abnormal. The percentage of participants in each Baker Grade is reported.|Interim analysis: 12 months|Full analysis population included all participants.||percentage of participants|||Number
675407|NCT01639742|Secondary|Investigator Evaluation of Whether the Implant is Palpably Distinguishable From the Tissue|The investigator examined the breasts and evaluated whether the implant was palpably distinguishable from the tissue using a 5-point scale where 1=implant very easy to distinguish from the tissue to 5=implant indistinguishable from the tissue.|6 months|Full analysis population included all participants.||score on a scale||Standard Deviation|Mean
675674|NCT01636778|Secondary|Number of Participants With Sustained Virologic Response (SVR) in Part 2|Participants with SVR were defined as those with undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) at 24 weeks post-completion of treatment period Part 2|From Antiviral Baseline up to Week 48 in Part 2|FAS2 Population.||Participants|||Number
675414|NCT01639703|Secondary|Permeability Surface According to Immunohistochemistry Parameter (CD31)|"CD31 is an immunohistochemistry marker of microvessel density. CD31 labelling was quantified and in case of positive quantification, classified in the following categories: 1-10%, 10-50% and >50%. In case of absence of CD31 labelling, lesions were classified in the CD31 0% category."|Within a week from CT perfusion to surgery|A total of 77 patients were analyzed for CT perfusion and immunohistochemistry parameters. A patient could have several lesions.||mL/100 grams/min|lesions|Standard Deviation|Mean
675415|NCT01639703|Secondary|Permeability Surface According to Immunohistochemistry Parameter (Glutamine Synthetase)|"Glutamine synthetase is an immunohistochemistry parameter of hepatocellular carcinoma phenotype.
Glutamine synthetase labelling was quantified and in case of positive quantification, classified in the following categories: 1-10%, 10-50% and >50%. In case of absence of glutamine synthetase labelling, lesions were classified in the glutamine synthetase 0% category."|Within a week from CT perfusion to surgery|A total of 77 patients were analyzed for CT perfusion and immunohistochemistry parameters. A patient could have several lesions in different groups: 3 patients presented at least 1 lesion in group10-50% and another lesion in group >50%; 2 patients presented at least 1 lesion in group >50% and 1 missing data; 2 patients presented missing data.||mL/100 grams/min|lesions|Standard Deviation|Mean
675416|NCT01639703|Secondary|Blood Flow According to Immunohistochemistry Parameter (CD31)|"CD31 is an immunohistochemistry marker of microvessel density. CD31 labelling was quantified and in case of positive quantification, classified in the following categories: 1-10%, 10-50% and >50%. In case of absence of CD31 labelling, lesions were classified in the CD31 0% category."|Within a week from CT perfusion to surgery|A total of 77 patients were analyzed for CT perfusion and immunohistochemistry parameters. A patient could have several lesions.||mL/100 grams/min|lesions|Standard Deviation|Mean
675417|NCT01639703|Secondary|Blood Flow According to Immunohistochemistry Parameter (Glutamine Synthetase)|"Glutamine synthetase is an immunohistochemistry parameter of hepatocellular carcinoma phenotype.
Glutamine synthetase labelling was quantified and in case of positive quantification, classified in the following categories: 1-10%, 10-50% and >50%. In case of absence of glutamine synthetase labelling, lesions were classified in the glutamine synthetase 0% category."|Within a week from CT perfusion to surgery|A total of 77 patients were analyzed for CT perfusion and immunohistochemistry parameters. A patient could have several lesions in different groups: 3 patients presented at least 1 lesion in group10-50% and another lesion in group >50%; 2 patients presented at least 1 lesion in group >50% and 1 missing data; 2 patients presented missing data.||mL/100 grams/min|lesions|Standard Deviation|Mean
675418|NCT01639703|Secondary|Blood Volume According to Immunohistochemistry Parameter (CD31)|"CD31 is an immunohistochemistry marker of microvessel density. CD31 labelling was quantified and in case of positive quantification, classified in the following categories: 1-10%, 10-50% and >50%. In case of absence of CD31 labelling, lesions were classified in the CD31 0% category."|Within a week from CT perfusion to surgery|A total of 77 patients were analyzed for CT perfusion and immunohistochemistry parameters. A patient could have several lesions.||mL/100 grams|lesions|Standard Deviation|Mean
675419|NCT01639703|Secondary|Blood Volume According to Immunohistochemistry Parameter (Glutamine Synthetase)|"Glutamine synthetase is an immunohistochemistry parameter of hepatocellular carcinoma phenotype.
Glutamine synthetase labelling was quantified and in case of positive quantification, classified in the following categories: 1-10%, 10-50% and >50%. In case of absence of glutamine synthetase labelling, lesions were classified in the glutamine synthetase 0% category."|Within a week from CT perfusion to surgery|A total of 77 patients were analyzed for CT perfusion and immunohistochemistry parameters. A patient could have several lesions in different groups: 3 patients presented at least 1 lesion in group10-50% and another lesion in group >50%; 2 patients presented at least 1 lesion in group >50% and 1 missing data; 2 patients presented missing data.||mL/100 grams|lesions|Standard Deviation|Mean
675420|NCT01639703|Secondary|Hepatic Perfusion Index (HPI) According to Degree of Lesions Differentiation|The mean level of each CT perfusion parameter was compared between well differentiated and moderately/poorly differentiated lesions according to WHO classification evaluated off-site.|Within a week from CT perfusion to surgery|"A total of 77 patients were analyzed for CT perfusion parameters: 38 had lesions assessed as well differentiated, 42 had lesions assessed as moderately/poorly differentiated and 3 had lesions assessed as well differentiated and moderately/poorly differentiated."||percentage|lesions|Standard Deviation|Mean
675421|NCT01639703|Secondary|Total Liver Perfusion (TLP) According to Degree of Lesions Differentiation|"The mean level of each CT perfusion parameter was compared between well differentiated and moderately/poorly differentiated lesions according to WHO classification evaluated off-site.
TLP = ALP + PVP"|Within a week from CT perfusion to surgery|"A total of 77 patients were analyzed for CT perfusion parameters: 38 had lesions assessed as well differentiated, 42 had lesions assessed as moderately/poorly differentiated and 3 had lesions assessed as well differentiated and moderately/poorly differentiated."||mL/min/100 mL|lesions|Standard Deviation|Mean
675422|NCT01639703|Secondary|Portal Venous Liver Perfusion (PVP) According to Degree of Lesions Differentiation|The mean level of each CT perfusion parameter was compared between well differentiated and moderately/poorly differentiated lesions according to WHO classification evaluated off-site.|Within a week from CT perfusion to surgery|"A total of 77 patients were analyzed for CT perfusion parameters: 38 had lesions assessed as well differentiated, 42 had lesions assessed as moderately/poorly differentiated and 3 had lesions assessed as well differentiated and moderately/poorly differentiated."||mL/min/100 mL|lesions|Standard Deviation|Mean
675423|NCT01639703|Secondary|Arterial Liver Perfusion (ALP) According to Degree of Lesions Differentiation|The mean level of each CT perfusion parameter was compared between well differentiated and moderately/poorly differentiated lesions according to WHO classification evaluated off-site.|Within a week from CT perfusion to surgery|"A total of 77 patients were analyzed for CT perfusion parameters: 38 had lesions assessed as well differentiated, 42 had lesions assessed as moderately/poorly differentiated and 3 had lesions assessed as well differentiated and moderately/poorly differentiated."||mL/min/100 mL|lesions|Standard Deviation|Mean
675507|NCT01638468|Secondary|Vasopressor Support|Percentage of participants receiving vasopressor support during the index procedure. Vasopressor support are medications administered to prevent the narrowing of blood vessels.|Index Procedure|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint||percentage of participants|||Number
675424|NCT01639703|Primary|Permeability Surface (PS) According to Degree of Lesions Differentiation|The mean level of each CT perfusion parameter was compared between well differentiated and moderately/poorly differentiated lesions according to WHO classification evaluated off-site.|Within a week from CT perfusion to surgery|"A total of 77 patients were analyzed for CT perfusion parameters: 38 had lesions assessed as well differentiated, 42 had lesions assessed as moderately/poorly differentiated and 3 had lesions assessed as well differentiated and moderately/poorly differentiated."||mL/100 grams/min|lesions|Standard Deviation|Mean
675425|NCT01639703|Primary|Blood Flow (BF) According to Degree of Lesions Differentiation|The mean level of each CT perfusion parameter was compared between well differentiated and moderately/poorly differentiated lesions according to WHO classification evaluated off-site.|Within a week from CT perfusion to surgery|"A total of 77 patients were analyzed for CT perfusion parameters: 38 had lesions assessed as well differentiated, 42 had lesions assessed as moderately/poorly differentiated and 3 had lesions assessed as well differentiated and moderately/poorly differentiated."||mL/100 grams/min|lesions|Standard Deviation|Mean
675426|NCT01639703|Primary|Blood Volume (BV) According to Degree of Lesions Differentiation|The mean level of each CT perfusion parameter was compared between well differentiated and moderately/poorly differentiated lesions according to WHO classification evaluated off-site.|Within a week from CT perfusion to surgery|"A total of 77 patients were analyzed for CT perfusion parameters: 38 had lesions assessed as well differentiated, 42 had lesions assessed as moderately/poorly differentiated and 3 had lesions assessed as well differentiated and moderately/poorly differentiated."||mL/100 grams|lesions|Standard Deviation|Mean
675427|NCT01639560|Secondary|Prolonged Smoking Outcome at 24 Weeks (End of Study)|To determine the efficacy of 12 weeks of varenicline therapy in achieving increased smoking abstinence rates at 6 months in light smokers. Prolonged abstinence is defined as no smoking since 2 weeks after the target quit date.|24 weeks|||participants|||Number
675428|NCT01639560|Secondary|Point Prevalence Smoking Outcome at 24 Weeks (End of Study)|To determine the efficacy of 12 weeks of varenicline therapy in achieving increased smoking abstinence rates at 6 months in light smokers. Point prevalence is defined as no smoking in the past 7 days.|24 weeks|||participants|||Number
675429|NCT01639560|Primary|Prolonged Smoking Outcome at 12 Weeks (End of Treatment)|To determine the efficacy of 12 weeks of varenicline therapy in achieving increased smoking abstinence rates in light smokers. Prolonged abstinence is defined as no smoking since 2 weeks after the target quit date.|12 weeks|||participants|||Number
675430|NCT01639560|Primary|Point Prevalence Smoking Outcome at 12 Weeks (End of Treatment)|To determine the efficacy of 12 weeks of varenicline therapy in achieving increased smoking abstinence rates in light smokers. Point prevalence is defined as no smoking in the past 7 days.|12 weeks|||participants|||Number
675431|NCT01639469|Primary|Total Falls During the 1-year Follow-up|Total number of falls over the 1-year follow-up; self-reported falls collected on a weekly basis and totaled over the follow-up period.|up to 1 year|"2 participants not analyzed were excluded due to early loss to follow-up and had no fall data collected."||Total count of falls|||Number
675438|NCT01639352|Secondary|Toxicity Profile of Protocol Therapy|Number of patients experiencing adverse events and/or toxicities while receiving protocol therapy.|Up to 2 Years|||Participants|||Count of Participants
675439|NCT01639352|Secondary|Duration of Overall Response|Duration of Overall Response in participants achieving complete response (CR) or partial response (PR) to SOM230 treatment. The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Overall response is assessed per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions assessed by MRI or CT Scan. CR is defined as disappearance of all target lesions; PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|Up to 2 Years|No participants achieved complete response (CR) or partial response (PR) to protocol therapy.|||||
675440|NCT01639352|Secondary|Overall Response Rate (ORR)|Proportion of patients achieving Complete Response and Partial Response (CR+PR) to protocol therapy per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI or CT Scan. CR is defined as disappearance of all target lesions; PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|Up to 2 Years|||Participants|||Count of Participants
675441|NCT01639352|Secondary|Rate of Overall Survival (OS)|Rate of Overall Survival (OS) in participants receiving protocol therapy. OS will be measured from the date of enrollment to the date of death or last contact.|From Enrollment Until Study Completion, Approximately 3 Years|||months||95% Confidence Interval|Median
675442|NCT01639352|Secondary|Rate of Progression-Free Survival (PFS):|Rate of Progression-Free Survival (PFS). PFS will be measured from the date of enrollment to the earliest date of documented disease progression or death from any cause, whichever is earlier. Progression is defined according to RECIST v 1.1 criteria as an at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. For patients who remain alive without progression, follow up time will be censored at the date of last disease assessment.|From Enrollment Until Study Completion, Approximately 3 Years|||months||95% Confidence Interval|Median
675443|NCT01639352|Primary|Disease Control Rate (DCR)|The disease-control rate (DCR) is defined as the proportion of participants achieving a best overall response of complete response (CR), partial response or stable disease (SD) per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions assessed by MRI or CT Scan, and that is maintained for at least 8 weeks. CR is defined as disappearance of all target lesions; PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; and SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|At least 2 cycles, about 8 weeks|||Participants|||Count of Participants
675444|NCT01639222|Secondary|Amount of Calcium Excreted in Urine From 0 to 6 Hours Post Dose Corected for Creatinine (Ae0-6h/Creatinine)|To account for potential inaccuracies in urine collection, creatinine correction of calcium excretion was also assessed. Ca2+ Ae0-6h/Creatinine was obtained by dividing the urinary concentration of calcium by the urinary creatinine concentration.|Day 3 of Period 1 (Baseline) and Day 3 in Period 2. Samples will be taken 0-6 Hours postdose|PK/PD set||liters||Standard Deviation|Mean
675445|NCT01639222|Primary|Area Under the Curve From 0 to 6 Hours Post Dose of Parathyroid Hormone (PTH AUC0-6h) in Serum|The area under the curve from 0 to 6 hours post dose of parathyroid hormone (PTH AUC0-6h) in serum, calculated using the linear trapezoidal formula.|Day 3 in Period 1 (Reference) and Day 3 in Period 2. Samples were taken at predose, 0.5, 1, 2, 3, 4, and 6 hour post dose.|PK/PD set||h*pg/mL||Standard Deviation|Mean
675446|NCT01639222|Primary|Amount of Calcium Excreted in Urine From 0 Hours up to 6 Hours Post Dose (Ca2+ Ae0-6h)|Ca2+ Ae0-6h was calculated as the urine volume of the urine collected from 0 to 6 hours multiplied by the calcium concentration measured in urine.|Day 3 of Period 1 (Reference) and Day 3 in Period 2. Samples were taken 0-6 Hours post dose|The Pharmacokinetic/Pharmacodynamic (PK/PD) Set included all enrolled subjects who received at least one dose of the mock treatment who had reliable values of either the primary PK parameter Ca2+ Ae0-6h in both periods or the primary PD parameter PTH AUC0-6h in both periods.||mmol||Standard Deviation|Mean
675447|NCT01639157|Secondary|Peak Heart Rate|Heart rate was measured with an automated monitor. Higher values represent greater heart rate. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions.|This measure was completed at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.|||beats per minute||Standard Error|Mean
675448|NCT01639157|Secondary|Peak Diastolic Blood Pressure|Diastolic blood pressure was measured with an automated monitor. Higher values represent greater diastolic pressure. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions.|This measure was completed at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.|||mmHg||Standard Error|Mean
675449|NCT01639157|Secondary|Peak Oral Temperature|Oral temperature was measured with an automated monitor. Higher values represent greater temperature. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions.|This measure was completed at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.|||Degrees Fahrenheit||Standard Error|Mean
675450|NCT01639157|Secondary|"Peak Ratings of Talkative, Friendly on the Visual Analog Scale"|"Subjects rated their feelings of Talkative, Friendly on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.|||arbitary units on a Visual Analog Scale||Standard Error|Mean
675508|NCT01638468|Secondary|Change in Heart Rate|Change in heart rate at termination of the index procedure as compared to the pre-procedure assessment.|Baseline to Post Index Procedure|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 2 participants were not evaluable.||beats per minute||Standard Deviation|Mean
675451|NCT01639157|Secondary|"Peak Ratings of Willing to Take Again on the Visual Analog Scale"|"Subjects rated their feelings of Willing to Take Again on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.|||arbitary units on a Visual Analog Scale||Standard Error|Mean
675452|NCT01639157|Secondary|"Peak Ratings of Stimulated on the Visual Analog Scale"|"Subjects rated their feelings of Stimulated on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.|||arbitary units on a Visual Analog Scale||Standard Error|Mean
675453|NCT01639157|Secondary|"Peak Ratings of Sluggish, Fatigued, Lazy on the Visual Analog Scale"|"Subjects rated their feelings of Sluggish, Fatigued, Lazy on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.|||arbitary units on a Visual Analog Scale||Standard Error|Mean
675454|NCT01639157|Secondary|"Peak Ratings of Shaky, Jittery on the Visual Analog Scale"|"Subjects rated their feelings of Shaky, Jittery on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.|||arbitary units on a Visual Analog Scale||Standard Error|Mean
675455|NCT01639157|Secondary|"Peak Ratings of Rush on the Visual Analog Scale"|"Subjects rated their feelings of Rush on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.|||arbitary units on a Visual Analog Scale||Standard Error|Mean
675456|NCT01639157|Secondary|"Peak Ratings of Restless on the Visual Analog Scale"|"Subjects rated their feelings of Restless on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.|||arbitary units on a Visual Analog Scale||Standard Error|Mean
675457|NCT01639157|Secondary|"Peak Ratings of Performance Improved on the Visual Analog Scale"|"Subjects rated their feelings of Performance Improved on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.|||arbitary units on a Visual Analog Scale||Standard Error|Mean
675458|NCT01639157|Secondary|"Peak Ratings of Performance Impaired on the Visual Analog Scale"|"Subjects rated their feelings of Performance Impaired on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.|||arbitary units on a Visual Analog Scale||Standard Error|Mean
675459|NCT01639157|Secondary|"Peak Ratings of Willing to Pay For on the Visual Analog Scale"|"Subjects rated their feelings of Willing to Pay For on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.|||arbitary units on a Visual Analog Scale||Standard Error|Mean
675460|NCT01639157|Secondary|"Peak Ratings of Nervous, Anxious on the Visual Analog Scale"|"Subjects rated their feelings of Nervous, Anxious on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.|||arbitary units on a Visual Analog Scale||Standard Error|Mean
675461|NCT01639157|Secondary|"Peak Ratings of Nauseated, Queasy, Sick to Stomach on the Visual Analog Scale"|"Subjects rated their feelings of Nauseated, Queasy, Sick to Stomach on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.|||arbitary units on a Visual Analog Scale||Standard Error|Mean
675509|NCT01638468|Secondary|Systemic Systolic Arterial Blood Pressure|Systemic systolic arterial blood pressure at termination of the index procedure.|Post Index Procedure|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint.||mmHg||Standard Deviation|Mean
675462|NCT01639157|Secondary|"Peak Ratings of Like Drug on the Visual Analog Scale"|"Subjects rated their feelings of Like Drug on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.|||arbitary units on a Visual Analog Scale||Standard Error|Mean
675463|NCT01639157|Secondary|"Peak Ratings of Irregular/Racing Heartbeat on the Visual Analog Scale"|"Subjects rated their feelings of Irregular/Racing Heartbeat on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.|||arbitary units on a Visual Analog Scale||Standard Error|Mean
675464|NCT01639157|Secondary|"Peak Ratings of High on the Visual Analog Scale"|"Subjects rated their feelings of High on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.|||arbitary units on a Visual Analog Scale||Standard Error|Mean
675465|NCT01639157|Secondary|"Peak Ratings of Good Effects on the Visual Analog Scale"|"Subjects rated their feelings of Good Effects on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.|||arbitary units on a Visual Analog Scale||Standard Error|Mean
675466|NCT01639157|Secondary|"Peak Ratings of Euphoric on the Visual Analog Scale"|"Subjects rated their feelings of Euphoric on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.|||arbitary units on a Visual Analog Scale||Standard Error|Mean
675467|NCT01639157|Secondary|"Peak Ratings of Bad Effects on the Visual Analog Scale"|"Subjects rated their feelings of Bad Effects on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.|||arbitary units on a Visual Analog Scale||Standard Error|Mean
675468|NCT01639157|Secondary|"Peak Ratings of Any Effect on the Visual Analog Scale"|"Subjects rated their feelings of Any Effect on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.|||arbitary units on a Visual Analog Scale||Standard Error|Mean
675469|NCT01639157|Secondary|"Peak Ratings of Active, Alert, Energetic on the Visual Analog Scale"|"Subjects rated their feelings of Active, Alert, Energetic on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.|||arbitary units on a Visual Analog Scale||Standard Error|Mean
675470|NCT01639157|Secondary|Peak Score on Stimulant Subscale of the Adjective Rating Scale|"Subjects completed 16 items that loaded into the Stimulant Subscale of the Adjective Rating Scale. The items were rated 0-4 on a Likert-type scale and the sum for the 16 sedative items was summed to yield the Stimulant Subscale score. The maximum score for this scale was 64, the minimum was 0. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.|||arbitrary units on a Likert-type scale||Standard Error|Mean
675471|NCT01639157|Secondary|Peak Systolic Blood Pressure|Systolic blood pressure was measured with an automated monitor. Higher values represent greater systolic pressure. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions.|This measure was completed at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.|||mmHg||Standard Error|Mean
675472|NCT01639157|Secondary|Peak Score on Sedative Subscale of the Adjective Rating Scale|"Subjects completed 16 items that loaded into the Sedative Subscale of the Adjective Rating Scale. The items were rated 0-4 on a Likert-type scale and the sum for the 16 sedative items was summed to yield the Sedative Subscale score. The maximum score for this scale was 64, the minimum was 0. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.|||arbitrary units on a Likert-type scale||Standard Error|Mean
675510|NCT01638468|Secondary|Change in Systemic Systolic Arterial Blood Pressure|Change in systemic systolic arterial blood pressure at termination of the index procedure as compared to the pre-procedure assessment.|Baseline to Post Index Procedure|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint||mmHg||Standard Deviation|Mean
675473|NCT01639157|Primary|Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative|The reinforcing effects of cocaine were determined using a modified progressive ratio procedure (Stoops et al., 2010) in which subjects made 6 choices between available each available cocaine dose and money (US$0.25). Reinforcing effects are measured for each cocaine dose during both buspirone and placebo maintenance.|One test per cocaine dose level per intervention for each participant over his/her 2 week inpatient admission|||Number of Cocaine Choices||Standard Error|Mean
675474|NCT01639144|Primary|Postoperative Infection and Delayed Wound Healing.|Postoperative deep incisional surgical site infection and delayed wound healing (lack of primary healing of skin edges typically with wound secretion).|Infection: 30 days after surgery. Delayed wound healing: 60 days.|Patients have foot and/or ankle surgery.||participants|||Number
675505|NCT01638507|Primary|Composite Rate of Cardiac Death and Target Vessel Myocardial Infarction (MI)||12 months|The primary analysis set was the Intent-To-Treat (ITT) population, defined as all patients who signed the written informed consent and were enrolled in the study.||percentage of participants||95% Confidence Interval|Number
676307|NCT01627002|Secondary|Pharmacokinetic Parameters: Area Under the Plasma Concentration-time Curve From Zero to Infinity||Up to 12 time-points up to 48 hours post dose|||ng.h/mL||Standard Deviation|Mean
675495|NCT01638559|Primary|Number of Operationally Tolerant Participants|The number of participants that are operationally tolerant, defined as those who successfully withdraw from immunosuppression and maintain normal allograft status as assessed by liver biopsy and liver tests 12 months after complete immunosuppression withdrawal.|12 Months after Complete immunosuppression withdrawal|Per Protocol||Participants|||Count of Participants
675496|NCT01638507|Secondary|Clinical Endpoint: Bleeding Complications in General||12 months|||percentage of bleeding complications|||Number
675497|NCT01638507|Secondary|Clinical Endpoint: Stroke||12 months|||percentage of strokes|||Number
675498|NCT01638507|Secondary|Clinical Endpoint: ST||12 months|||percentage of ST|||Number
675499|NCT01638507|Secondary|Clinical Endpoint: MI||12 months|||percentage of MIs|||Number
675500|NCT01638507|Secondary|Clinical Endpoint: TVR||12 months|||percentage of TVR|||Number
675501|NCT01638507|Secondary|Clinical Endpoint: TLR||12 months|||percentage of TLR|||Number
675502|NCT01638507|Secondary|Dual Antiplatelet Therapy (DAPT) Compliance||12 months|||percentage of compliance|||Number
675503|NCT01638507|Secondary|Clinical Endpoint: Death||12 months|||percentage of death|||Number
675504|NCT01638507|Secondary|Composite Endpoints: Major Adverse Cardiac Events (MACE), Target Lesion Failure (TLF), Target Vessel Failure (TVF), Cardiac Death and Target Vessel MI||12 months|||percentage of composite|||Number
676308|NCT01627002|Secondary|Pharmacokinetic Parameters: Terminal Half-life (t1/2)||Up to 12 time-points up to 48 hours post dose|||hours||Standard Deviation|Mean
675512|NCT01638468|Secondary|Change in Systolic Pulmonary Arterial Blood Pressure|Change in systolic pulmonary arterial blood pressure at termination of the index procedure as compared to the pre-procedure assessment.|Baseline to Post Index Procedure|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 1 participant was not evaluable.||mmHg||Standard Deviation|Mean
675513|NCT01638468|Secondary|Death - Cardiac Cause|Number of participant deaths due to cardiac causes occurring within 3 months of the index procedure.|3 months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint||participants|||Number
675514|NCT01638468|Secondary|Death - All Cause|Number of participant deaths due to any reason occurring within 3 months of the index procedure.|3 months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint||participants|||Number
675515|NCT01638468|Secondary|Technical Success|Percentage of patients with successful placement and operation of the AngioJet catheter in the pulmonary arteries during the index procedure|Index Procedure|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint||percentage of participants|||Number
675516|NCT01638468|Primary|Change in Right Ventricular (RV) to Left Ventricular (LV) Ratio at 24 - 48 Hours as Measured by Echocardiography|The change in the subannular end-diastolic RV/LV ratio at 24-48 hrs following thrombectomy compared to baseline measurements as assessed by an independent core lab analysis. RV and LV values will be measured by echocardiography, a technique utilizing ultrasound waves to assess heart activity.|Baseline to 24-48 hours|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint||ratio||Standard Deviation|Mean
675517|NCT01638312|Primary|Fructose Identification in Urine to Detect the Viral Infection : Number of Participants With Positive and Negative Waveform|"This detection technique, after a viral infection caused by the use of cell pathological changes and urine metabolic waste - fructose concentration, derivatives.Health News voltage changes to detect viral pathogens of activity and virulence. Because viral infection caused by the voltage change has its typical, So you can use voltage measurements to calibrate the presence and activity of a viral infection.
1.How to interpretation the data The gap between values on X-axis is σ, and 50 is a reference to the center position. For example, the sample maybe contain with HIV virus if σ≧10 units.
σ≧10 abnormal positive (+) σ＜10 normal negative (-)"|Participants provided urine samples once|||participants|||Number
675518|NCT01638000|Secondary|Percentage of Participants With Major Improvement in PPBC: ≥2 Point Improvement at Week 12 and Final Visit|A responder is defined as a participant with ≥2 point improvement in PPBC from baseline.|Baseline to Week 12|FAS population. LOCF was used for final visit only. N is the number of participants with available data at each time point.||percentage of participants|||Number
675519|NCT01638000|Secondary|Percentage of Participants With Improvement in PPBC: ≥1 Point Improvement at Week 12 and Final Visit|A responder is defined as a participant with ≥1 point improvement in PPBC from baseline.|Baseline to Week 12|FAS population. LOCF was used for final visit only. N is the number of participants with available data at each time point.||percentage of participants|||Number
675520|NCT01638000|Secondary|Percentage of Participants With Improvement in Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Final Visit|A responder is defined as a participant with >=1 or >=2 or >=3 or >=4 or >=5 or 6-point improvement from baseline in TS-Likert scale.|Baseline to final visit (up to Week 12)|FAS population. LOCF was used.||percentage of participants|||Number
675521|NCT01638000|Secondary|Percentage of Participants With Improvement of Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Week 12|A responder is defined as a participant with ≥1, ≥2, ≥3, ≥4, ≥5 or 6-point improvement from baseline in TS-Likert scale.|Baseline to Week 12|FAS population.||percentage of participants|||Number
675522|NCT01638000|Secondary|Percentage of Participants With Improvement in HRQoL Scales as Assessed by the OAB-q: ≥10 Points Improvement in OAB-q at Week 12 and Final Visit|A responder is defined as a participant with >=10 points improvement in the total HRQL score from baseline.|Baseline to Week 12|FAS population. LOCF was used for final visit only. N is the number of participants with available data at each time point.||percentage of participants|||Number
675523|NCT01638000|Secondary|Percentage of Participants With Improvement in Symptom Bother Score as Assessed by the OAB-q: ≥ 10 Points Improvement in OAB-q at Week 12 and Final Visit|A responder is defined as a participant with ≥10 points improvement in symptom bother from baseline.|Baseline to Week 12|FAS population. LOCF was used for final visit only. N is the number of participants with available data at each time point.||percentage of participants|||Number
675524|NCT01638000|Secondary|Change From Baseline to Week 12 and the Final Visit in the Patient’s Assessment of Treatment Satisfaction Questionnaire-Likert Scale|"The Treatment Satisfaction (TS)-Likert Scale was a self-rated scale with the participant answering the question How satisfied were you with your treatment? with on a scale from 1 (extremely dissatisfied) to 7 (extremely satisfied)."|Baseline and Week 12|FAS population. LOCF was used for final visit only. N is the number of participants with available data at each time point.||units on a scale||Standard Error|Least Squares Mean
675525|NCT01638000|Secondary|Change From Baseline to Week 12 and the Final Visit in the Patient's Assessment of Treatment Satisfaction (TS)-Visual Analog Scale (VAS)|"The Treatment Satisfaction (TS)-Visual Analogue Scale (VAS) was a self-rated scale with the participant answering the question Are you satisfied with your treatment? and placing a vertical mark on a line from 0 (No, not at all) to 10 (Yes, completely)."|Baseline and Week 12|FAS population. LOCF was used for final visit only. N is the number of participants with available data at each time point.||units on a scale||Standard Error|Least Squares Mean
675536|NCT01638000|Secondary|Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and Week 12|FAS population who has non-missing values at both Baseline and specified visit.||participants|||Number
675526|NCT01638000|Secondary|Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Patient Perception of Bladder Condition (PPBC)|The Patient Perception of Bladder Condition (PPBC) questionnaire is a single-item questionnare used to assess participants’ perceptions and impressions of their bladder condition. Participants assessed their bladder condition using a 6-point categorical scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems.|Baseline and Week 4, Week 8, Week 12|FAS population. LOCF was used for final visit only. N is the number of participants with available data at each time point.||units on a scale||Standard Error|Least Squares Mean
675527|NCT01638000|Secondary|Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Total Health-Related Quality of Life (HRQoL) Score as Assessed by the OAB-q|The OAB-q is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: coping, concern, sleep, social interaction). The total score is calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement.|Baseline and Week 4, Week 8, Week 12|FAS population. LOCF was used for final visit only. N is the number of participants with available data at each time point.||units on a scale||Standard Error|Least Squares Mean
675528|NCT01638000|Secondary|Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q)|The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consists of 8 items, scored from 1 to 6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicates an improvement.|Baseline and Week 4, Week 8, Week 12|FAS population. LOCF was used for final visit only. N is the number of participants with available data at each time point.||units on a scale||Standard Error|Least Squares Mean
675529|NCT01638000|Secondary|Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and final visit (up to Week 12)|FAS population who has non-missing values at both Baseline and specified visit. LOCF was used.||participants|||Number
675530|NCT01638000|Secondary|Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and final visit (up to Week 12)|FAS population who has non-missing values at both Baseline and specified visit. LOCF was used.||participants|||Number
675531|NCT01638000|Secondary|Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and final visit (up to Week 12)|FAS population who has non-missing values at both Baseline and specified visit. LOCF was used.||participants|||Number
675532|NCT01638000|Secondary|Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and final visit (up to Week 12)|FAS population who has non-missing values at both Baseline and specified visit. LOCF was used.||participants|||Number
675533|NCT01638000|Secondary|Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and final visit (up to Week 12)|FAS population who has non-missing values at both Baseline and specified visit. LOCF was used.||participants|||Number
675534|NCT01638000|Secondary|Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and Week 12|FAS population who has non-missing values at both Baseline and specified visit.||participants|||Number
675535|NCT01638000|Secondary|Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and Week 12|FAS population who has non-missing values at both Baseline and specified visit.||participants|||Number
675574|NCT01637935|Secondary|Incident Diagnosis of Bladder Cancer by Time Since Starting Pioglitazone (10 Year Analysis)||January 1, 1997 to December 31, 2012|||events per 100,000 person years||95% Confidence Interval|Number
676309|NCT01627002|Secondary|Pharmacokinetic Parameters: Time of Occurrence of the Maximum Observed Plasma Concentration (Tmax)||Up to 12 time-points up to 48 hours post dose|||hours||Standard Deviation|Mean
675537|NCT01638000|Secondary|Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and Week 12|FAS population who has non-missing values at both Baseline and specified visit.||participants|||Number
675538|NCT01638000|Secondary|Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and Week 12|FAS population who has non-missing values at both Baseline and specified visit.||participants|||Number
675539|NCT01638000|Secondary|Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and Week 8|FAS population who has non-missing values at both Baseline and specified visit.||participants|||Number
675540|NCT01638000|Secondary|Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and Week 8|FAS population who has non-missing values at both Baseline and specified visit.||participants|||Number
675541|NCT01638000|Secondary|Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and Week 8|FAS population who has non-missing values at both Baseline and specified visit.||participants|||Number
675542|NCT01638000|Secondary|Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and Week 8|FAS population who has non-missing values at both Baseline and specified visit.||participants|||Number
675543|NCT01638000|Secondary|Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and Week 8|FAS population who has non-missing values at both Baseline and specified visit.||participants|||Number
675544|NCT01638000|Secondary|Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and Week 4|FAS population who has non-missing values at both Baseline and specified visit.||participants|||Number
675545|NCT01638000|Secondary|Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and Week 4|FAS population who has non-missing values at both Baseline and specified visit.||participants|||Number
675546|NCT01638000|Secondary|Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and Week 4|FAS population who has non-missing values at both Baseline and specified visit.||participants|||Number
675547|NCT01638000|Secondary|Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and Week 4|FAS population who has non-missing values at both Baseline and specified visit.||participants|||Number
675575|NCT01637935|Primary|Incident Diagnosis of Bladder Cancer (10-year Analysis)|Incident bladder cancers were identified from January 1, 1997 to December 31, 2012.|January 1, 1997 to December 31, 2012|All participants.||events per 100,000 person years||95% Confidence Interval|Number
675690|NCT01636778|Secondary|Time in Weeks to Achieve Platelet Count >= 100 Gi/L|Participants were assessed for achieving platelet counts >=100 Gi/L during Part 1. Platelet counts were measured by blood draw.|From Baseline up to Week 9 in Part 1|FAS1 Population: all participants enrolled in Part 1.||Participants|||Number
675548|NCT01638000|Secondary|Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire|The European Quality of Life 5-Dimensions Questionnaire (EQ-5D-5L) is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and Week 4|FAS population who have non-missing values at both Baseline and specified visit.||participants|||Number
675549|NCT01638000|Secondary|Percentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and Final Visit|A responder is defined as a participant who reported incontinence episodes at baseline and reported no incontinence episodes during the treatment period at specified visit.|Week 4, Week 8, Week 12|FAS-I population. LOCF was used for final visit only. N is the number of participants with available data at each time point.||percentage of participants|||Number
675550|NCT01638000|Secondary|Percentage of Participants With 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and Final Visit|A responder is defined as a participant with at least 50% decrease from baseline in mean number of incontinence episodes per 24 hours during the treatment period at specified visit.|Week 4, Week 8, Week 12|FAS-I population. LOCF was used for final visit only. N is the number of participants with available data at each time point.||percentage of participants|||Number
675551|NCT01638000|Secondary|Percentage of Participants With Normalization of Micturitions at Weeks 4, 8, 12 and Final Visit|A responder is defined as a participant who has ≥8 micturitions at baseline and has <8 micturitions per 24 hours during the treatment period at each specified visit, where change from baseline is <0.|Week 4, Week 8, Week 12|FAS population. LOCF was used for final visit only. N is the number of participants with available data at each timepoint.||percentage of participants|||Number
675552|NCT01638000|Secondary|Change From Baseline in Mean Number of Nocturia Episodes Per 24 Hours After 4, 8 and 12 Weeks of Treatment|A nocturia episode is defined as waking at night ≥1 times to void (i.e., any voiding associated with sleep disturbance between the time the patient goes to bed with the intention to sleep until the time the patient gets up in the morning with the intention to stay awake). The mean number of nocturia episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.|Baseline and Week 4, Week 8, Week 12|FAS population. Only participants with at least one nocturia episode at baseline were included in the analysis. N is the number of participants with available data at each time point.||nocturia episodes||Standard Error|Least Squares Mean
675553|NCT01638000|Secondary|Number of Nocturia Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit|A nocturia episode is defined as waking at night ≥1 times to void (i.e., any voiding associated with sleep disturbance between the time the patient goes to bed with the intention to sleep until the time the patient gets up in the morning with the intention to stay awake). The total number of nocturia episodes were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit.|Week 4, Week 8, Week 12|FAS population. LOCF was used for final visit only. Only participants with at least one nocturia episode at baseline were included in the analysis. N is the number of participants with available data at each time point.||nocturia episodes||Standard Error|Mean
675554|NCT01638000|Secondary|Change From Baseline in Mean Number of Pads Used Per 24 Hours After 4, 8 and 12 Weeks of Treatment|The mean number of pads per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.|Baseline and Week 4, Week 8 , Week 12|FAS population. Only participants with at least one pad used at baseline were included in this analysis. N is the number of participants with available data at each time point.||pads||Standard Error|Least Squares Mean
675555|NCT01638000|Secondary|Number of Pads Used at 4, 8 and 12 Weeks of Treatment and at the Final Visit|The total number of pads per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit.|Week 4, Week 8, Week 12|FAS population. LOCF was used in final visit only. Only participants with at least one pad used at baseline were included in this analysis. N is the number of participants with available data at each time point.||pads||Standard Error|Mean
675556|NCT01638000|Secondary|Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Level of Urgency|Urgency level was rated by the participant during the 3-day micturition diary period using the PPIUS 5-point categorical scale: 0. No urgency; 1. Mild urgency; 2. Moderate urgency; 3. Severe urgency; 4. Urgency incontinence.|Baseline and Week 4, Week 8, Week 12|FAS population. LOCF was used in final visit only. N is the number of participants with available data at each time point.||units on a scale||Standard Error|Least Squares Mean
675557|NCT01638000|Secondary|Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours|An urgency episode is a sudden compelling desire to pass urine immediately followed by an incontinent event or the patient having to rush to the toilet and make it in time; severity recorded as 3 (severe urgency) or 4 (urgency incontinence) on the Patient Perception of the Intensity of Urgency Scale (PPIUS) validated scale. The mean number of urgency episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.|Baseline and Week 4, Week 8, Week 12|FAS population. LOCF was used for final visit only. Only participants with at least one urgency episode (grade 3 or 4) at baseline were included in this analysis. N is the number of participants with available data at each time point.||urgency episodes||Standard Error|Least Squares Mean
675558|NCT01638000|Secondary|Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours|An urgency incontinence episode is any involuntary leakage of urine accompanied by or immediately proceeded by urgency. The mean number of urgency incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.|Baseline and Week 4, Week 8, Week 12|FAS-I population. Only participants with at least one urgency incontinence episode at baseline were included in the analysis. N is the number of participants with available data at each time point.||urgency incontinence episodes||Standard Error|Least Squares Mean
675593|NCT01637584|Secondary|Pittsburgh Sleep Quality Index (PSQI):|Self-report sleep quality measure. Scores range from 0 to 21, with higher scores reflecting poorer sleep quality.|Baseline and post-treatment at 8-10 weeks|9 of the 20 participants who were randomized to prazosin and 13 of the participants randomized to prazosin provided scans pre- and post-treatment that were of sufficiency quality to be included in the final analyses.||units on a scale||Standard Deviation|Mean
675559|NCT01638000|Secondary|Number of Urgency Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit|An urgency incontinence episode is any involuntary leakage of urine accompanied by or immediately proceeded by urgency. The total number of urgency incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit.|Week 4, Week 8, Week 12|FAS-I population. LOCF was used for final visit only. Only participants with at least one urgency incontinence episode at baseline were included in the analysis. N is the number of participants with available data at each time point.||urgency incontinence episodes||Standard Error|Mean
675560|NCT01638000|Secondary|Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Incontinence Episodes Per 24 Hours|An incontinence episode is any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.|Baseline and Week 4, Week 8, Week 12|FAS-I population. N is the number of participants with available data at each time point.||incontinence episodes||Standard Error|Least Squares Mean
675561|NCT01638000|Secondary|Number of Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit|An incontinence episode is any involuntary leakage of urine. The total number of incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit.|Week 4, Week 8, Week 12|FAS-Incontinence (FAS-I) - consisted of all FAS participants with ≥1 incontinence episode at baseline. LOCF was used for final visit only. N is the number of participants with available data at each time point.||incontinence episodes||Standard Error|Mean
675562|NCT01638000|Secondary|Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Micturitions Per 24 Hours||Baseline and Week 4, Week 8, Week 12|Full Analysis Set (FAS) - consisted of all randomized participants who took ≥ 1 dose of double-blind study drug and who recorded ≥1 micturition measurement in the baseline diary and ≥1 micturition measurement in a post-baseline diary. N is the number of participants with available data at each time point.||micturitions||Standard Error|Least Squares Mean
675563|NCT01638000|Secondary|Percentage of Participants Reporting at Least One Treatment-emergent Adverse Event of Dry Mouth, Constipation or Blurred Vision During Double-blind Treatment Period|A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE; defined as any untoward medical occurrence in a patient administered a study drug) that started or worsened in the period from the first double-blind medication intake until 30 days after the last double-blind medication intake. The following TEAEs were selected for inclusion in the analysis: Dry mouth (aptyalism, dry mouth, dry throat), constipation (constipation), blurred vision (vision blurred, myopia, refraction disorder, accommodation disorder).|From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks)|SAF population||percentage of participants|||Number
675564|NCT01638000|Primary|Change From Baseline to Final Visit in the Mean Number of Micturitions Per 24 Hours|A micturition is any voluntary urination (excluding incontinence only episodes). The mean number of micturitions per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.|Baseline and final visit (up to Week 12)|Per Protocol Set (PPS) - all randomized participants who took ≥1 dose of double-blind study drug and who recorded ≥1 micturition in the baseline diary and ≥1 micturition in a post-baseline diary who had completed the study with no major protocol violations which could impact the primary endpoint. Last observation carried forward (LOCF) was used.||micturitions||Standard Error|Least Squares Mean
675565|NCT01637961|Other Pre-specified|Aurora A Kinase Expression|Aurora A Kinase expression will be assessed for associations with patient demographics and clinical outcome (response, PFS at 6 months, PFS, and OS).|Up to 5 years||||||
675566|NCT01637961|Secondary|PFS|Characterized graphically and using descriptive statistics such as median survival.|Up to 5 years||||||
675567|NCT01637961|Secondary|Adverse Events as Assessed by NCI CTCAE Version 4.0|Toxicities will be tabulated by severity and frequency.|Up to 5 years||||||
675568|NCT01637961|Secondary|Overall Survival|The observed length of life from entry into the study to death or the date of last contact.|From study entry to death or last contact, up to 5 years.|Eligible and treated patients.||months||95% Confidence Interval|Median
675569|NCT01637961|Primary|Tumor Response|Complete and Partial Tumor Response by RECIST 1.1. Patient response uses best overall response while on therapy. Complete response is defined as the disappearance of all target lesions and non-target lesions, and any pathological lymph nodes (whether target or non-target) must have reduction in the short axis to <10 mm. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete or partial response requires confirmation at greater than or equal to 4 weeks from initial documentation.|Every other cycle for the first 6 months; then every 3 months thereafter until withdrawal from study treatment or disease progression is confirmed.|Eligible and treated patients||percentage of participants||90% Confidence Interval|Number
675570|NCT01637961|Primary|Progression-free Survival (PFS) > 6 Months|Whether or not the patient survived progression-free for at least 6 months. 90% confidence interval (Bonferroni Corrected). Progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). Progression includes the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.|Assessed every other cycle for the first 6 months; then every 3 months from the date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months.|Eligible and Treated Patients||percentage of participants||90% Confidence Interval|Number
675571|NCT01637935|Secondary|Stage of Bladder Cancer (10 Year Analysis)||January 1, 1997 to December 31, 2012|Participants diagnosed with bladder cancer.||percentage of participants|||Number
675572|NCT01637935|Secondary|Incident Diagnosis of Bladder Cancer by Cumulative Dose of Pioglitazone (10 Year Analysis)||January 1, 1997 to December 31, 2012|All participants.||events per 100,000 person years||95% Confidence Interval|Number
675573|NCT01637935|Secondary|Incident Diagnosis of Bladder Cancer by Duration of Pioglitazone Therapy (10 Year Analysis)||January 1, 1997 to December 31, 2012|All participants.||events per 100,000 person years||95% Confidence Interval|Number
675576|NCT01637922|Primary|Naloxone: Geometric Mean Steady-state C24hr on Day 1 and on Day 9.|These are the unadjusted summary statistics on the original scale for steady-state plasma concentration of faldaprevir 24 hours after the last dose|0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9|This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.||[pg/mL]||Geometric Coefficient of Variation|Geometric Mean
675577|NCT01637922|Primary|Naloxone: Geometric Mean Steady-state Cmax on Day 1 and on Day 9.|These are the unadjusted summary statistics on the original scale for the maximum measured concentration of faldaprevir in plasma at steady state.|0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9|This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.||[pg/mL]||Geometric Coefficient of Variation|Geometric Mean
675578|NCT01637922|Primary|Naloxone: Geometric Mean Steady-state AUC0-24 on Day 1 and on Day 9.|These are the unadjusted summary statistics on the original scale for area under the concentration time curve (AUC) of faldaprevir in plasma over a uniform dosing interval from 0 to 24 hours.|0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9|This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.||[pg*h/ml]||Geometric Coefficient of Variation|Geometric Mean
675579|NCT01637922|Primary|Norbuprenorphine: Geometric Mean Steady-state C24hr on Day 1 and on Day 9.|These are the unadjusted summary statistics on the original scale for steady-state plasma concentration of faldaprevir 24 hours after the last dose|0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9|This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.||[pg/mL]||Geometric Coefficient of Variation|Geometric Mean
675580|NCT01637922|Primary|Norbuprenorphine: Geometric Mean Steady-state Cmax on Day 1 and on Day 9.|These are the unadjusted summary statistics on the original scale for the maximum measured concentration of faldaprevir in plasma at steady state.|0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9|This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.||[pg/mL]||Geometric Coefficient of Variation|Geometric Mean
675581|NCT01637922|Primary|Norbuprenorphine: Geometric Mean Steady-state AUC0-24 on Day 1 and on Day 9.|These are the unadjusted summary statistics on the original scale for area under the concentration time curve (AUC) of faldaprevir in plasma over a uniform dosing interval from 0 to 24 hours.|0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9|This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.||[pg*h/ml]||Geometric Coefficient of Variation|Geometric Mean
675582|NCT01637922|Secondary|Pharmacodynamic Assessment of Withdrawal From Either Methadone or Buprenorphine/Naloxone Using the Subjective Opiate Withdrawal Scale (SOWS)-Change From Baseline|The SOWS is a subjective scale self-evaluated by the subject. The SOWS shows items reflecting the common motor, autonomic, gastrointestinal, musculo-skeletal, and psychic symptoms of opiate withdrawal. Subjects are instructed to rate each symptom on a scale of 0 to 4 (0=not at all, 1=a little, 2=moderately, 3=quite a bit, 4=extremely) at designated times [c.f. Section 3.1]. The minimum possible SOWS score is 0, the maximum 64. The following subjective criteria are answered by the subject using the scale below: 1) I feel anxious, 2) I feel like yawning 3) I am perspiring, 4) My eyes are watering, 5) My nose is running, 6) I have goose flesh, 7) I am shaking 8) I have hot flushes, 9) I have cold flushes, 10) My bones and muscles ache, 11) I feel restless, 12) I feel nauseous, 13) I feel like vomiting, 14) My muscles twitch, 15) I have cramps in my stomach, 16) I feel like shooting up now. Higher score indicates increasing severity of opiate withdrawal syndrome.|Baseline, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12 and End of treatment|This set included all subjects who took at least one dose of study drug.||units on a scale||Full Range|Median
675583|NCT01637922|Primary|Buprenorphine: Geometric Mean Steady-state C24hr on Day 1 and on Day 9.|These are the unadjusted summary statistics on the original scale for steady-state plasma concentration of faldaprevir 24 hours after the last dose|0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9|This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.||[pg/mL]||Geometric Coefficient of Variation|Geometric Mean
675594|NCT01637584|Primary|Whole Brain Relative Regional Cerebral Metabolic Rate of Glucose|The reported Z value reflect the magnitude of the state difference (Wake vs. Non-REM or Wake vs. REM) within the prazosin group pre-to-post treatment, and after using a mask to adjust for the spurious effects of the passage of time.|Baseline and post-intervention at 8-10 weeks|9 of the 20 participants who were randomized to prazosin and 13 of the participants randomized to placebo provided scans pre- and post-treatment that were of sufficiency quality to be included in the final analyses.||Z values|||Number
675584|NCT01637922|Primary|Buprenorphine: Geometric Mean Steady-state Cmax on Day 1 and on Day 9.|These are the unadjusted summary statistics on the original scale for the maximum measured concentration of faldaprevir in plasma at steady state.|0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9|This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.||[pg/ml]||Geometric Coefficient of Variation|Geometric Mean
675585|NCT01637922|Primary|Buprenorphine: Geometric Mean Steady-state AUC0-24 on Day 1 and on Day 9.|These are the unadjusted summary statistics on the original scale for area under the concentration time curve (AUC) of faldaprevir in plasma over a uniform dosing interval from 0 to 24 hours.|0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9|This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.||[pg*h/ml]||Geometric Coefficient of Variation|Geometric Mean
675586|NCT01637922|Secondary|Pharmacodynamic Assessment of Withdrawal From Either Methadone or Buprenorphine/Naloxone Using the Objective Opiate Withdrawal Scale (OOWS)-Change From Baseline|The OOWS is conducted by a trained independent examiner for either the presence or absence of the following symptoms during a 10 minute observation period at designated times during the trial. The minimum possible OOWS score is 0 and the maximum possible score is 13. Objective criteria: Yawning, Rhinorrhoea, Piloerection, perspiration, lacrimation, mydriasis, hot and cold flushes, restlessness, vomiting, tremors, anxiety, muscle twitches, abdominal cramps. Higher score indicates increasing severity of opiate withdrawal syndrome.|Baseline, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12 and End of treatment|This set included all subjects who took at least one dose of study drug.||units on a scale||Full Range|Median
675587|NCT01637922|Primary|S-methadone: Geometric Mean Steady-state C24hr on Day 1 and on Day 9|These are the unadjusted summary statistics on the original scale for steady-state plasma concentration of faldaprevir 24 hours after the last dose|0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9|This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.||[ng/mL]||Geometric Coefficient of Variation|Geometric Mean
675588|NCT01637922|Primary|S-methadone: Geometric Mean Steady-state Cmax on Day 1 and on Day 9|These are the unadjusted summary statistics on the original scale for the maximum measured concentration of faldaprevir in plasma at steady state.|0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9|This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.||[ng/mL]||Geometric Coefficient of Variation|Geometric Mean
675589|NCT01637922|Primary|S-methadone: Geometric Mean Steady-state AUC0-24 on Day 1 and on Day 9|These are the unadjusted summary statistics on the original scale for area under the concentration time curve (AUC) of faldaprevir in plasma over a uniform dosing interval from 0 to 24 hours.|0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9|This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.||[ng*h/ml]||Geometric Coefficient of Variation|Geometric Mean
675590|NCT01637922|Primary|R-methadone: Geometric Mean Steady-state C24hr on Day 1 and on Day 9.|These are the unadjusted summary statistics on the original scale for steady-state plasma concentration of faldaprevir 24 hours after the last dose|0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9|This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.||[ng/mL]||Geometric Coefficient of Variation|Geometric Mean
675591|NCT01637922|Primary|R-methadone: Geometric Mean Steady-state Cmax on Day 1 and on Day 9.|These are the unadjusted summary statistics on the original scale for the maximum measured concentration of faldaprevir in plasma at steady state.|0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9|This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.||[ng/ml]||Geometric Coefficient of Variation|Geometric Mean
675592|NCT01637922|Primary|R-methadone: Geometric Mean Steady-state AUC0-24 on Day 1 and on Day 9.|These are the unadjusted summary statistics on the original scale for area under the concentration time curve (AUC) of faldaprevir in plasma over a uniform dosing interval from 0 to 24 hours.|0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9|This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.||[ng*h/mL]||Geometric Coefficient of Variation|Geometric Mean
675618|NCT01637246|Primary|Change From Baseline in Intraocular Pressure (IOP)|IOP is a measurement of the fluid pressure inside the eye. A negative change from baseline indicates an improvement.|Baseline, 12 Weeks|All patients who met the study entry criteria and have data for this outcome measure||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
675595|NCT01637272|Secondary|LAR PK Parameter: Ctrough - at Steady State (ss) by Dose|In the LAR treatment phase, monthly injections of pasireotide LAR 10, 20, 30 and 40 mg were given to participants and trough concentration at steady state (Ctrough,ss) were obtained but due to only 1 participant in the 40mg arm, standard deviation could not be calculated.|M4 to M12|The LAR PK analysis set consisted of all patients who received at least one of the scheduled full monthly im LAR injections and had evaluable PK data (concentration) in the LAR phase of the study (Visit 9 through end of LAR phase visit).||ng/mL||Standard Deviation|Mean
675596|NCT01637272|Secondary|Pasireotide Concentrations in LAR Phase|Summary of pasireotide concentrations following monthly i.m. injections of pasireotide LAR by incident dose (LAR Pharmacokinetic set)|M7 to M12|The LAR PK analysis set consisted of all patients who received at least one of the scheduled full monthly im LAR injections and had evaluable PK data (concentration) in the LAR phase of the study (Visit 9 through end of LAR phase visit).||ng/mL||Standard Deviation|Mean
675597|NCT01637272|Secondary|Summary of LAR PK Parameters by Dose|Summary of plasma PK parameter Cmax, p2 , 2nd injection and Ctrough, d28 associated with LAR injection (LAR Core phase)|M4 to M6|The LAR PK analysis set consisted of all patients who received at least one of the scheduled full monthly im LAR injections and had evaluable PK data (concentration) in the LAR phase of the study (Visit 9 through end of LAR phase visit).||ng/mL||Standard Deviation|Mean
675598|NCT01637272|Secondary|Plasma PK Parameter of AUC0-3h, d21, End _inj and AUC0-3h, d28, 3rd_inj Associated With LAR (LAR Core Phase)||M4 to M6|The LAR PK analysis set consisted of all patients who received at least one of the scheduled full monthly im LAR injections and had evaluable PK data (concentration) in the LAR phase of the study (Visit 9 through end of LAR phase visit).||hr*ng/mL||Standard Deviation|Mean
675599|NCT01637272|Secondary|Plasma Pharmacokinetic (PK) Parameter of Pasireotide: Tmax, ss, After s.c. Injection|A pre-dose PK blood sample was collected before the morning pasireotide s.c. dose of 50 μg, 100 ug, 150 ug and 200 ug. OGTT was performed right after the morning s.c. dose (Time point zero); additional PK blood samples were collected at the same time points as the OGTT evaluation at 30, 60, 90, 120, 150 and 180 minutes.|M1 to M3|The sc PK analysis set consisted of all patients who received at least one of the scheduled full daily sc dose (3 injections) and had evaluable PK data (concentration) in the sc dose escalation phase of the study (Visit 2 through Visit 8).||hr||Full Range|Median
675600|NCT01637272|Secondary|Plasma Pharmacokinetic (PK) Parameter of Pasireotide: AUC0-3h, ss, After s.c. Injection|A pre-dose PK blood sample was collected before the morning pasireotide s.c. dose of 50 μg, 100 ug, 150 ug and 200 ug. OGTT was performed right after the morning s.c. dose (Time point zero); additional PK blood samples were collected at the same time points as the OGTT evaluation at 30, 60, 90, 120, 150 and 180 minutes.|M1 to M3|The sc PK analysis set consisted of all patients who received at least one of the scheduled full daily sc dose (3 injections) and had evaluable PK data (concentration) in the sc dose escalation phase of the study (Visit 2 through Visit 8).||hr*ng/mL||Standard Deviation|Mean
675601|NCT01637272|Secondary|Plasma Pharmacokinetic (PK) Parameter of Pasireotide: Cmax, ss (Steady State) and Ctrough, ss, After s.c. Injection|A pre-dose PK blood sample was collected before the morning pasireotide s.c. dose of 50 μg, 100 ug, 150 ug and 200 ug. OGTT was performed right after the morning s.c. dose (Time point zero); additional PK blood samples were collected at the same time points as the OGTT evaluation at 30, 60, 90, 120, 150 and 180 minutes. 'n' = number of subjects with non-missing values|M1 to M3|The sc PK analysis set consisted of all patients who received at least one of the scheduled full daily sc dose (3 injections) and had evaluable PK data (concentration) in the sc dose escalation phase of the study (Visit 2 through Visit 8).||ng/mL||Standard Deviation|Mean
675602|NCT01637272|Secondary|Patient Global Assessment at the End of Months 3, 6 and 12|"Treatment with pasireotide LAR (both early and late dumping scores), was assessed by patient global assessment. Patient Global Assessment served as an additional approach to symptom based measurement by DSQ. It incorporated a patient global assessment question:
“Considering all the ways that your disease affects you, rate how you are feeling during the last 7 days compared with your situation before starting the study” .Patients Global Assessment was measured utilizing a 7 point scale (from 1=a lot worse to 7= a lot better)."|M3, M6, M12|The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase. The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase.||scores on a scale||Standard Deviation|Mean
675603|NCT01637272|Secondary|﻿Dumping Score Questionnaire (DSQ) at the End of Months 3, 6 and 12|Absolute Dumping Score Questionnaire (DSQ) scores at end of Months 3, 6 & 12 from s.c. baseline. DSQ = disease-specific PRO scale. The questionnaire uses a 5-point Likert scale (0, none; 1, mild; 2, moderate; 3, severe; 4, very severe) to ask Pt. to evaluate intensity of 10 early dumping symptoms (within 30 minutes (<30 minutes) after food ingestion). The questionnaire also evaluates 5 late dumping symptoms (more than 1.5 hours (>90 minutes) after food ingestion). Early & late dumping score calculated by adding the scores of respective questions. A cumulative dumping score is obtained by adding early & late scores. At study start patients were assessed using DSS (older version of DSQ); however after the implementation of protocol amendment 2, all patients used DSQ. DSQ Range: (min (None) – max (Very severe)): Early dumping: 0-40; Late Dumping: 0-20; Cumulative: 0-60. Lower scores represent a better outcome.|M3, M6, M12|The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase. The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase.||scores on a scale||Standard Deviation|Mean
675619|NCT01637090|Secondary|Effect of mTOR on Tumors|Determine mTOR (mammilian target of rapamycin) pathway activation and number of regulatory T cells (Tregs) in pre-treated tumor tissue and evaluate changes following treatment|one year|Study was pre-maturely terminated. No data were collected for the Outcome Measure|||||
675620|NCT01637090|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Determine the adverse event profile and tolerability of everolimus in patients with CTCL|Up to one year|||participants|||Number
675621|NCT01637090|Secondary|Progression-free Survival|Determine progression-free survival of CTCL patients treated with everolimus|two years after discontinuing study treatment|Study was pre-maturely terminated. No data were collected for the Outcome Measure|||||
675622|NCT01637090|Secondary|Time to Response|Determine time to response (TTR)/duration of objective response (DOR)|three months|Study was pre-maturely terminated. No data were collected for the Outcome Measure|||||
675604|NCT01637272|Secondary|﻿Dumping Severity Score (DSS) at the End of Months 3, 6 and 8|Absolute Dumping Severity Score (DSS) scores at end of M3, M6 & M8. At study start patients were assessed using DSS (older version of DSQ); however after the implementation of protocol amendment 2, all patients were expected to use DSQ. No results available for M12 as last patient that answered the DSS was at M8. DSS = disease-specific patient (Pt.) reported outcome (PRO) questionnaire uses a 4-point Likert scale (0, absent; 1, mild; 2, relevant; 3, severe; 4) to ask Pt. to evaluate intensity of early dumping symptoms (within 30 minutes (<30 minutes) after food ingestion). The questionnaire also evaluates 65 late dumping symptoms (more than 1.5 hours (>90 minutes) after food ingestion). Early & late dumping score calculated by adding the scores of the respective questions. Cumulative dumping score is obtained by adding early & late scores. DSS Range (min (absent) – max (severe)): Early dumping: 0-24; Late Dumping: 0-18; Cumulative: 0-42. Lower scores represent a better outcome.|M3, M6, M8|The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase. The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase.||scores on a scale||Standard Deviation|Mean
675605|NCT01637272|Secondary|﻿Health-related Quality of Live (HRQoL) Short Form- 36 (SF-36) Score(s)|Absolute HRQoL SF-36 Scores at end of the Months 3, 6 and 12 from s.c. baseline. SF-36, a 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting. Items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.|M3, M6, M12|The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase. The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase.||scores on a scale||Standard Deviation|Mean
675606|NCT01637272|Secondary|﻿﻿Gastric Inhibitory Polypeptide (GIP) Levels at During OGTT|Absolute ﻿﻿﻿Gastric Inhibitory Polypeptide (GIP) levels at the end of Months 3, 6 and 12 at different time points.|M3, M6, M12|"The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase.
The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase."||pmol/L||Standard Deviation|Mean
675607|NCT01637272|Secondary|﻿﻿Glucagon-like Peptide 1 (GLP-1) Levels During OGTT|Absolute ﻿Glucagon-like peptide 1 (GLP-1) levels at the end of at the end of Months 3, 6 and 12 at different time points.|M3, M6, M12|The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase. The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase.||pmol/L||Standard Deviation|Mean
675608|NCT01637272|Secondary|﻿Glucagon Levels During OGTT|Absolute glucagon levels at the end of Months 3, 6 & 12|M3, M6, M12|The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase. The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase.||pmol/L||Standard Deviation|Mean
675609|NCT01637272|Secondary|﻿Insulin Levels During OGTT|Absolute insulin levels at the end of M3, M6, M12|M3, M6, M12|The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase. The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase.||pmol/L||Standard Deviation|Mean
675610|NCT01637272|Secondary|﻿Response Rate in Hematocrit Levels|﻿Percentage of patients with change in hematocrit >= 3% from pre-OGTT to 30 minutes post OGTT.|M3, M6, M12|The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase. The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase.||Percentage of participants|||Number
675611|NCT01637272|Secondary|Response Rate in Pulse Rate|Pulse rate was defined as percentage of patients with change in pulse rate >=10 bpm from pre-OGTT to 30 minutes post OGTT.|at baseline, M3, M6, M12|The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase. The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase.||Percentage of participants|||Number
675612|NCT01637272|Secondary|Response Rate in Plasma Glucose Level|Response rate is defined as percentage of patients with no glucose values < 60 mg/dL at 90,120, 150 and 180 min during the Oral Glucose Tolerance Test (OGTT) at the end of 6 months (end of LAR/Core phase) and at the end of 12 months (extension phase)|at Month 6 (M6), Month 12 (M12)|The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase.||percentage of participants||95% Confidence Interval|Number
675613|NCT01637272|Primary|Response Rate in Plasma Glucose Level|Response rate is defined as percentage of patients with no glucose values < 60 mg/dL at 90,120, 150 and 180 min during the Oral Glucose Tolerance Test (OGTT) at the end of s.c. dose escalation phase|at Month 3 (M3)|The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase.||percentage of participants||95% Confidence Interval|Number
675614|NCT01637246|Secondary|Percentage of Patients Continuing on Therapy After 12 Weeks|Percentage of patients continuing on therapy after 12 weeks was assessed as Yes or No.|12 Weeks|All patients who met the study entry criteria and have data for this outcome measure||Percentage of Patients|||Number
675615|NCT01637246|Secondary|Percentage of Patients Who Maintained Better Compliance With Treatment|Percentage of patients who maintained better compliance with treatment than prior therapy was assessed by the patient on a 3-point scale (better, equal, and worse compliance).|12 Weeks|All patients who met the study entry criteria and have data for this outcome measure||Percentage of Patients|||Number
675616|NCT01637246|Secondary|Physician Assessment of Tolerability Using a 4-Point Scale|Physician assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The percentage of patients assessed as good and very good combined are reported.|12 Weeks|All patients who met the study entry criteria and have data for this outcome measure||Percentage of Patients|||Number
675617|NCT01637246|Secondary|Patient Assessment of Tolerability Using a 4-Point Scale|Patient assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The percentage of patients assessed as good and very good combined are reported.|12 Weeks|All patients who met the study entry criteria and have data for this outcome measure||Percentage of Patients|||Number
675624|NCT01636986|Primary|Mean Change From Baseline in Subjective Contact Lens-related Dryness Symptoms at Week 4 as Assessed by the CLDEQ|Contact lens symptoms were evaluated using the Contact Lens and Dry Eye Questionnaire (CLDEQ). The participant indicated the frequency with which 9 common contact lens-related ocular surface dryness symptoms were experienced over the previous week. Each symptom was rated on a 5-point scale (1=never, 5=constantly). Both eyes contributed to the mean. A more negative change number indicates a greater perceived improvement, namely, lessening of the symptom.|Day 0, Week 4|All enrolled and randomized participants who completed the study.||Units on a scale||Standard Deviation|Mean
675625|NCT01636960|Secondary|Number of Participants Discontinuing Study Drug Because of AEs|An adverse event was any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.|From first dose to last dose of treatment; up to 260 Weeks|All participants receiving at least one dose of study drug.||Participants|||Number
675626|NCT01636960|Secondary|Safety: Number of Participants Experiencing Adverse Events (AEs)|An adverse event was any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.|From first dose through follow-up; up to 265 Weeks|All participants who received at least one dose of study drug.||Participants|||Number
675627|NCT01636960|Primary|Number of Participants Experiencing Dose-limiting Toxicities (DLTs) - Induction Phase|A DLT was an event (clinical or laboratory) that resulted in a change in the given dose.|From first dose to end of induction phase; up to 8 Weeks|All participants in the induction phase of the study||Participants|||Number
675628|NCT01636947|Secondary|Percentage of Participants With No Vomiting - Acute and Delayed Stages|A vomiting episode was defined as one or more episodes of emesis (expulsion of stomach contents through the mouth) or retches (an attempt to vomit that is not productive of stomach contents). Acute Stage=0 to 24 hours after initiation of MEC. Delayed Stage=25 to 120 hours after initiation of MEC.|Day 1, Day 2 to Day 5|The mITT population consisted of all randomized participants who received chemotherapy, took ≥1 dose of study drug and had ≥1 post-treatment assessment on Day 1 and Day 2.||Percentage of Participants|||Number
675629|NCT01636947|Secondary|Percentage of Participants With One or More Clinical Adverse Event|An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition, which is temporally associated with the use of the study drug, is also an adverse event. Nausea and vomiting experienced during Days 1-6 were not counted as adverse events unless they were reported as a serious adverse event.|Day 1 through Day 29 (Up to 28 days after first dose of study drug)|All randomized participants who received chemotherapy and took ≥1 dose of study drug.||Percentage of Participants|||Number
675630|NCT01636947|Secondary|Number of Participants With No Use of a Rescue Therapy - Overall, Acute, and Delayed Stages|The percentage of participants who used no rescue therapy after initiation of MEC is presented for the Overall, Acute and Delayed Stages. Overall Stage=0 to 120 hours after initiation of MEC. Acute Stage=0 to 24 hours after initiation of MEC. Delayed Stage=25 to 120 hours after initiation of MEC.|Day 1 to Day 5|The mITT population consisted of all randomized participants who received chemotherapy, took ≥1 dose of study drug and had ≥1 post-treatment assessment on Day 1 and Day 2.||Percentage of Participants|||Number
675631|NCT01636947|Secondary|Percentage of Participants With No Impact on Daily Life - Overall Stage|"The Functional Living Index-Emesis questionnaire (FLIE) is a validated, participant-reported instrument to measure the impact of chemotherapy-induced nausea and vomiting on daily life. There are 9 nausea-related items and 9 vomiting-related items, each on a 7-point scale. For the purposes of this study, No Impact on daily life was defined as an average item score of >6 on the 7-point scale; a total score >108 indicates no impact on daily life. Overall Stage=0 to 120 hours after initiation of MEC."|Day 6|The mITT population consisted of all randomized participants who received chemotherapy, took ≥1 dose of study drug, had ≥1 post-treatment assessment on Day 1 and Day 2 and completed the FLIE questionnaire on Day 6.||Percentage of Participants|||Number
675632|NCT01636947|Secondary|Percentage of Participants With No Vomiting and No Significant Nausea - Overall Stage|"Nausea was to be assessed using a 100-mm horizontal visual analogue scale (VAS) located in the participant diary labeled: How much nausea have you had over the last 24 hours? The left end of the scale (0 mm) was labeled no nausea, and the right end of the scale (100 mm) is labeled nausea as bad as it could be. In this study, No Significant Nausea was defined as a VAS nausea rating <25 mm."|Days 1 to Day 5|The mITT population consisted of all randomized participants who received chemotherapy, took ≥1 dose of study drug and had ≥1 post-treatment assessment on Day 1 and Day 2.||Percentage of Participants|||Number
675633|NCT01636947|Secondary|Number of Emetic Events - Overall Stage|The number of emetic events that occurred during the Overall Stage (0 to 120 hours after initiation of MEC) are presented.|Hour 0 on Day 1 to Day 5 (approximately 120 hours)|The mITT population consisted of all randomized participants who received chemotherapy, took ≥1 dose of study drug and had ≥1 post-treatment assessment on Day 1 and Day 2.||Number of Emetic Events|||Number
675634|NCT01636947|Secondary|Percentage of Participants With a Complete Response - Overall, Acute, and Delayed Stages|A Complete Response was defined as no vomiting or dry heaves and no use of a rescue therapy. Overall Stage=0 to 120 hours after initiation of MEC. Acute Stage=0 to 24 hours after initiation of MEC. Delayed Stage=25 to 120 hours after initiation of MEC.|Hour 0 on Day 1 to Day 5 (approximately 120 hours)|The mITT population consisted of all randomized participants who received chemotherapy, took ≥1 dose of study drug and had ≥1 post-treatment assessment on Day 1 and Day 2.||Percentage of Participants|||Number
675635|NCT01636947|Primary|The Percentage of Participants With No Vomiting - Overall Stage|A vomiting episode was defined as one or more episodes of emesis (expulsion of stomach contents through the mouth) or retches (an attempt to vomit that is not productive of stomach contents). No vomiting during the Overall Stage was defined as no episodes of emesis during the 120 hours (Days 1-5) after initiation of moderately emetogenic chemotherapy (MEC).|Hour 0 on Day 1 to Day 5 (approximately 120 hours)|The modified intention-to-treat (mITT) population consisted of all randomized participants who received chemotherapy, took ≥1 dose of study drug and had ≥1 post-treatment assessment on Day 1 and Day 2.||Percentage of Participants|||Number
676310|NCT01627002|Secondary|Pharmacokinetic Parameters: Maximum Observed Plasma Concentration (Cmax)||Up to 12 time-points up to 48 hours post dose|||ng/mL||Standard Deviation|Mean
675636|NCT01636778|Secondary|Spleen Measurements as Assessed by Abdominal Ultrasound With Doppler During Follow-up Period After Part 2|Abdominal ultrasound with doppler were taken during Follow-up Period after Part 2 at FU Week 24. Questions were asked to assess masses suspicious for HCC, ascites, portal vein thrombosis detected, possiblility to measure spleen breadth, and OCSF. Spleen measurements included spleen length and spleen width (breadth).|FU Week 24|SP2 Population.||Cm||Standard Deviation|Mean
675637|NCT01636778|Secondary|Spleen Measurements as Assessed by Abdominal Ultrasound With Doppler in the Study|Abdominal ultrasound with doppler were taken at Baseline, Week 24, Week 48, WD/comp. Questions were asked to assess masses suspicious for HCC, ascites, portal vein thrombosis detected, possiblility to measure spleen breadth, and OCSF. Spleen measurements included spleen length and spleen width (breadth).|Baseline; Week 24, Week 48, Withdrawal/Completion|SP1 Population. Only those participants available at the specified time points were analyzed (n=X).||Centimeters (cm)||Standard Deviation|Mean
675638|NCT01636778|Secondary|Number of Participants With Abdominal Ultrasound With Doppler During Follow-up Period After Part 2|Abdominal ultrasound with doppler were taken during Follow-up Period after Part 2 at FU Week 24. Questions were asked to assess masses suspicious for hepatocellular carcinoma (HCC), ascites, portal vein thrombosis detected, possiblility to measure spleen breadth, and other clinically significant findings (OCSF).|FU Week 24|SP2 Population.||Participants|||Number
675639|NCT01636778|Secondary|Number of Participants With Abdominal Ultrasound With Doppler at the Indicated Time Points|Abdominal ultrasound with doppler were taken at Baseline, Week 24, Week 48, withdrawal (WD)/completion (comp). Questions were asked to assess masses suspicious for hepatocellular carcinoma (HCC), ascites, portal vein thrombosis detected, possiblility to measure spleen breadth, and other clinically significant findings (OCSF).|Baseline; Week 24, Week 48, Withdrawal/Completion|SP1 Population. Only those participants available at the specified time points were analyzed (n=X).||Participants|||Number
675640|NCT01636778|Secondary|Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) During Follow-up After Part 2|The number of participants with an ECG status of normal, abnormal, CS, or NCS, as determined by the Investigator, was reported. Normal= all ECG parameters within accepted normal ranges. Abnormal= ECG findings outside of normal ranges. CS= ECG with a CS abnormality that meets exclusion criteria. NCS= ECG with an abnormality not CS or meeting exclusion criteria, per Investigator, based on reasonable standards of clinical judgment.|FU Baseline and FU Week 24|SP2 Population.||Participants|||Number
675641|NCT01636778|Secondary|Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points|The number of participants with an ECG status of normal, abnormal, CS, or NCS, as determined by the Investigator, was reported. Normal= all ECG parameters within accepted normal ranges. Abnormal= ECG findings outside of normal ranges. CS= ECG with a CS abnormality that meets exclusion criteria. NCS= ECG with an abnormality not CS or meeting exclusion criteria, per Investigator, based on reasonable standards of clinical judgment.|Screening, Antiviral Baseline, Week 12, 24, 36, 48, Withdrawal|SP1 Population.||Participants|||Number
675642|NCT01636778|Secondary|Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2|Urinalysis parameters included: UB, UOB, UG, UK, pH, UP, USG and UU. The dipstick test gives results in a semi-quantitative manner. UB was categorized as (-), negative (Neg). UOB was categorised as 1+, 2+, 3+, (-), Neg, trace. UG results were categorized as 1+, (-), 0.5, Neg. UK parameters were categorized as as (-), Neg. pH results were in the range of pH from 5-8.5 in increments of 0.5. UP was categorized as (-), Neg, trace. UU was categorized as 1+, 0.1, 1, 2, 4, Neg, trace, normal. USG results were in the range from 1.000-1.030 in increments of 0.001.|FU Baseline and FU Week 24|SP2 Population.||Participants|||Number
675643|NCT01636778|Secondary|Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2|Urinalysis parameters included: UB, UOB, UG, UK, pH, UP, USG and UU. The dipstick test gives results in a semi-quantitative manner. UB was categorized as (-), negative (Neg). UOB was categorised as 1+, 2+, 3+, (-), Neg, trace. UG results were categorized as 1+, (-), 0.5, Neg. UK parameters were categorized as as (-), Neg. pH results were in the range of pH from 5-8.5 in increments of 0.5. UP was categorized as (-), Neg, trace. UU was categorized as 1+, 0.1, 1, 2, 4, Neg, trace, normal. USG results were in the range from 1.000-1.030 in increments of 0.001.|Antiviral Baseline,Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, Withdrawal|SP2 Population.||Participants|||Number
675644|NCT01636778|Secondary|Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period|Urinalysis parameters included: urine bilirubin (UB), urine occult blood (UOB), urine glucose (UG), urine ketones (UK), pH, urine protein (UP), urine specific gravity (USG) and urine urobilinogen (UU). The dipstick test gives results in a semi-quantitative manner. UB was categorized as (-), negative (Neg). UOB was categorised as 1+, 2+, 3+, (-), Neg, trace. UG results were categorized as (-), 0.5, Neg. UK parameters were categorized as as (-), Neg. pH results were in the range of pH from 5-8.5 in increments of 0.5. UP was categorized as 1+, (-), Neg, trace. UU was categorized as 1+, 0.1, 1, 2, 4, Neg, trace, normal. USG results were in the range from 1.000-1.030 in increments of 0.001.|Screening, Baseline, Week 1, 2, 3, 4, 7, 8, Withdrawal, FU Week 24|SP1 Population.||Participants|||Number
675645|NCT01636778|Secondary|Number of Participants With the Indicated Shifts From BL in Severity Grades for Hematology Parameters Per DAIDS During Follow-up Period After Part 2|Blood samples for the assessment of hematology parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL in Part 2 are reported, per severity grades by DAIDS, for levels of hemoglobin (low=anemia), lymphocytes (low=lymphocytopenia), total neutrophils (low=neutropenia), and white blood cells (low=leukocytopenia). Per the DAIDS toxicity table, grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.|From FU Week 4 to FU Week 24|SP2 Population,||Participants|||Number
675661|NCT01636778|Secondary|Mean Change From Antiviral Baseline in Heart Rate at the Indicated Time Points in Part 2|The heart rate was measured in participants at the indicated time points. Mean change from Antiviral Baseline was calculated as the value at the indicated time points minus the value at Antiviral Baseline.|Antiviral Baseline, Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, Withdrawal in Part 2|SP2 Population.||bpm||Standard Deviation|Mean
686351|NCT01490866|Secondary|Overall Survival (OS)|Defined as the time from first treatment until death from any cause.|every 8 weeks until progression then every 3 months for up to 5 years.|||months||95% Confidence Interval|Median
675646|NCT01636778|Secondary|Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 2|Blood samples for the assessment of hematology parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL in Part 2 are reported, per severity grades by DAIDS, for levels of hemoglobin (low=anemia), lymphocytes (low=lymphocytopenia), total neutrophils (low=neutropenia), and white blood cells (low=leukocytopenia). Per the DAIDS toxicity table, grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.|From Antiviral Baseline up to Week 48|SP2 Population.||Participants|||Number
675647|NCT01636778|Secondary|Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 1|Blood samples for the assessment of hematology parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL in Part 1 are reported, per severity grades by DAIDS, for levels of hemoglobin (low=anemia), lymphocytes (low=lymphocytopenia), total neutrophils (low=neutropenia), and white blood cells (low=leukocytopenia). Per the DAIDS toxicity table, grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.|From Baseline up to Week 9|SP1 Population.||Participants|||Number
675648|NCT01636778|Secondary|Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2|Blood samples for the assessment of clinical chemistry parameters were taken at intervals in Part 2. Clinical chemistry parameters included albumin, ALP, ALT, AST, total bilirubin, calcium, creatinine, potassium, sodium, and uric acid. Per DAIDS toxicity table, the grade ranges for each parameter are as follows: Grade (G) 0=none, 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.|From FU Week 4 to FU Week 24|SP2 Population.||Participants|||Number
675649|NCT01636778|Secondary|Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2|Blood samples for the assessment of clinical chemistry parameters were taken at intervals in Part 2. Clinical chemistry parameters included albumin, ALP, ALT, AST, total bilirubin, calcium, creatinine, potassium, sodium, and uric acid. Per DAIDS toxicity table, the grade ranges for each parameter are as follows: Grade (G) 0=none, 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.|From Antiviral Baseline up to Week 48|SP2 Population.||Participants|||Number
675650|NCT01636778|Secondary|Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1|Blood samples for the assessment of clinical chemistry parameters were taken at intervals in Part 1. Clinical chemistry parameters included albumin, alkaline phosphatase (ALP), ALT, aspartate amino transferase (AST), total bilirubin, calcium, creatinine, potassium, sodium, and uric acid. Per DAIDS toxicity table, the grade ranges for each parameter are as follows: Grade (G) 0=none, 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.|From Baseline up to Week 9|SP1 Population.||Participants|||Number
675651|NCT01636778|Secondary|Mean BMI at the Indicated Time Points During Follow-up Period After Part 2|The BMI for participants was calculated at the indicated time points as body weight in kilograms divided by height in meters squared.|FU Baseline, FU Week 4, FU Week 12 and FU Week 24 after Part 2|SP2 Population||kilogram per meters squared (kg/m^2)||Standard Deviation|Mean
675652|NCT01636778|Secondary|Mean Change From Baseline in BMI at the Indicated Time Points in Part 2|The BMI for participants was calculated at the indicated time points as body weight in kilograms divided by height in meters squared. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline|Baseline; Antiviral Baseline,Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, Withdrawal in Part 2|SP2 Population.||kg/m^2||Standard Deviation|Mean
675653|NCT01636778|Secondary|Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points in Part 1 With Follow-up Periodc|The BMI for participants was calculated at the indicated time points as body weight in kilograms divided by height in meters squared. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline|Baseline; Week 1, 2, 3, 4, 5, 6, 7, 8, 9, Withdrawal in Part 1 and FU Week 4, FU Week 12, FU Week 24|SP1 Population.||kilogram per meters squared (kg/m^2)||Standard Deviation|Mean
675654|NCT01636778|Secondary|Mean Body Temperature at the Indicated Time Points During Follow-up Period After Part 2|The Body temperature of participants was recorded at the indicated time points..|FU Baseline, FU Week 4, FU Week 12 and FU Week 24 after Part 2|SP2 Population||Degrees centigrade||Standard Deviation|Mean
675655|NCT01636778|Secondary|Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 2|The Body temperature of participants was recorded at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline|Baseline; Antiviral Baseline,Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, Withdrawal in Part 2|SP2 Population.||Degrees centigrade||Standard Deviation|Mean
675656|NCT01636778|Secondary|Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 1 With Follow-up Period|The Body temperature of participants was recorded at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.|Baseline; Week 1, 2, 3, 4, 5, 6, 7, 8, 9, Withdrawal in Part 1 and FU Week 4, FU Week 12, FU Week 24|SP1 Population.||Degrees centigrade||Standard Deviation|Mean
675657|NCT01636778|Secondary|Mean Weight at the Indicated Time Points During Follow-up Period After Part 2|The weight of participants was recorded at the indicated time points.|FU Baseline, FU Week 4, FU Week 12 and FU Week 24 after Part 2|SP2 Population||kg||Standard Deviation|Mean
675658|NCT01636778|Secondary|Mean Change From Baseline in Weight at the Indicated Time Points in Part 2|The weight of participants was recorded at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.|Baseline; Antiviral Baseline, Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, Withdrawal in Part 2|SP2 Population.||kg||Standard Deviation|Mean
675659|NCT01636778|Secondary|Mean Change From Baseline in Weight at the Indicated Time Points in Part 1 With Follow-up Period|The weight of participants was recorded at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.|Baseline; Week 1, 2, 3, 4, 5, 6, 7, 8, 9, Withdrawal in Part 1 and FU Week 4, FU Week 12, FU Week 24|SP1 Population.||Kilogram (kg)||Standard Deviation|Mean
686481|NCT01489956|Secondary|Cytokine Secretion Profile of T Cells Stimulated by KLH (Part A)|No data available for analyses.|Days 0, 9, 16|Data were not collected and therefore no analyses could be performed.|||||
675662|NCT01636778|Secondary|Mean Change From Baseline in Heart Rate at the Indicated Time Points in Part 1 With Follow-up Period|The heart rate was measured in participants at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.|Baseline; Week 1, 2, 3, 4, 5, 6, 7, 8, 9, Withdrawal in Part 1 and FU Week 4, FU Week 12, FU Week 24|SP1 Population.||Beats per minute (bpm)||Standard Deviation|Mean
675663|NCT01636778|Secondary|Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During Follow-up Period After Part 2|Participant’s blood pressure was measured at the indicated time points during the study. Systolic blood pressure is a measure of blood pressure while the heart is beating. Diastolic blood pressure is a measure of blood pressure while the heart is relaxed.|FU Baseline, FU Week 4, FU Week 12 and FU Week 24 after Part 2|SP2 Population.||mmHg||Standard Deviation|Mean
675664|NCT01636778|Secondary|Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2|Participant’s blood pressure was measured at the indicated time points during the study. Systolic blood pressure is a measure of blood pressure while the heart is beating. Diastolic blood pressure is a measure of blood pressure while the heart is relaxed. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline|Baseline; Antiviral Baseline,Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, Withdrawal in Part 2|SP2: consisted of all participants who were enrolled in Part 2 and received at least one dose of eltrombopag.||mmHg||Standard Deviation|Mean
675665|NCT01636778|Secondary|Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 With Follow-up Period|Participant’s blood pressure was measured at the indicated time points during the study. Systolic blood pressure is a measure of blood pressure while the heart is beating. Diastolic blood pressure is a measure of blood pressure while the heart is relaxed. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline|Baseline; Week 1, 2, 3, 4, 5, 6, 7, 8, 9, Withdrawal in Part 1 and FU Week 4, FU Week 12, and FU Week 24|SP1||Millimeter of mercury (mmHg)||Standard Deviation|Mean
675666|NCT01636778|Secondary|Number of Participants With Any AE and Any SAE During Follow-up Period After Part 2|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect.|From FU Baseline up to FU Week 24 after Part 2|SP2 Population||Participants|||Number
675667|NCT01636778|Secondary|Number of Participants With Any AE and Any SAE in Part 2|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect.|From Antiviral Baseline up to Week 48 in Part 2|Safety Population 2 (SP2): consisted of all participants who were enrolled in Part 2 and received at least one dose of eltrombopag.||Participants|||Number
675668|NCT01636778|Secondary|Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) in Part1|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect.|From Baseline up to week 9 in Part 1|Safety Population 1 (SP1) : consisted of all participants who were enrolled in Part 1 and received at least one dose of eltrombopag.||Participants|||Number
675669|NCT01636778|Secondary|Mean Serum HCV RNA at the Indicated Time Points During Follow-up Period After Part 2|The HCV is a small, enveloped, single-stranded, positive-sense RNA virus. Log-Transformed HCV RNA was assessed at FU Baseline, FU Week 12 and FU Week 24 during Follow-up Period after Part 2|FU Baseline, FU Week 12 and FU Week 24 after Part 2|FAS2 Population. Participants with any antiviral drugs during follow-up period after Part 2 were excluded from this analysis.||Log international unit per milliliter||Standard Deviation|Mean
675670|NCT01636778|Secondary|Mean Serum HCV RNA at the Indicated Time Points In Part 2|The HCV is a small, enveloped, single-stranded, positive-sense RNA virus. Log-Transformed HCV RNA was assessed at Screening, Antiviral Baseline, Part 2 week 4, 12, 24, 36, 48 and at withdrawal.|Screening, Antviral baseline; Week 4, 12, 24, 36, 48, Withdrawal in Part 2|FAS2 Population.||Log international unit per milliliter||Standard Deviation|Mean
675671|NCT01636778|Secondary|Number of Participants With End of Treatment Response (ETR) for Undetectable HCV RNA at the End of Peg-IFN/RBV Treatment in Part 2|ETR is defined as undetectable HCV RNA at the end of Peg-IFN/RBV treatment.|From Antiviral Baseline up to Week 48 in Part 2|FAS2 Population.||Participants|||Number
675672|NCT01636778|Secondary|Number of Participants With Early Virological Response (EVR) and Complete EVR (cEVR) in Part 2|EVR is defined as a clinically significant reduction from Baseline in HCV RNA (>=2 log10 decrease in HCV RNA or undetectable HCV RNA) after 12 weeks of antiviral treatment. cEVR, a subset of EVR, is defined exclusively as undetectable HCV RNA after 12 weeks of antiviral treatment.|From Antiviral Baseline up to Week 48 in Part 2|FAS2 Population.||Participants|||Number
675673|NCT01636778|Secondary|Number of Participants With Rapid Virological Response (RVR) and Extended RVR (eRVR) in Part 2|RVR is defined as the absence of detectable HCV RNA after 4 weeks of antiviral treatment. eRVR is defined as the absence of detectable HCV RNA between 4 weeks and 12 weeks after antiviral treatment.|From Antiviral Baseline up to Week 48 in Part 2|FAS2 Population.||Participants|||Number
675675|NCT01636778|Secondary|Number of Participants Achieving Adherence to Peg-IFN Alpha-2b Antiviral Therapy in Part 2|Adherence to antiviral therapy was defined as receiving at least 80% of the prescribed dose (investigator prescribed) of Peg-IFN alpha-2b and at least 80% of the prescribed dose (investigator prescribed) of RBV, for at least 80% of the planned duration.|From Antiviral Baseline up to Week 48 in Part 2|FAS2 Population. Only those particpants who received Peg-IFN alpha-2b antiviral therapy were analyzed.||Participants|||Number
675676|NCT01636778|Secondary|Number of Participants Achieving Adherence to Peg-IFN Alpha 2a Antiviral Therapy in Part 2|Adherence to antiviral therapy was defined as receiving at least 80% of the prescribed dose (investigator prescribed) of Peg-IFN alfa-2a and at least 80% of the prescribed dose (investigator prescribed) of RBV, for at least 80% of the planned duration.|From Antiviral Baseline up to Week 48 in Part 2|FAS2 Population. Only those particpants who received Peg-IFN alpha-2a antiviral therapy were analyzed.||Participants|||Number
675677|NCT01636778|Secondary|Number of Participants Achieving Adherence to Antiviral Therapy in Part 2|Adherence to antiviral therapy was defined as receiving at least 80% of the prescribed dose (investigator prescribed) of Peg-IFN alfa and at least 80% of the prescribed dose (investigator prescribed) of RBV, for at least 80% of the planned duration|From Antiviral Baseline up to Week 48 in Part 2|FAS2 Population.||Participants|||Number
675678|NCT01636778|Secondary|Number of Participants Who Discontinued Peg-IFN Alpha-2b Therapy in Part 2|Dosing discontinuation is defined as the occurrence of stopping the medication. Dosing discontinuation of Peg-IFN alpha-2b therapy was assessed up to 48 weeks in Part 2|From Antiviral Baseline up to Week 48 in Part 2|FAS2 Population. Only those particpants who received Peg-IFN alpha-2b antiviral therapy were analyzed.||Participants|||Number
675679|NCT01636778|Secondary|Number of Participants Who Discontinued Peg-IFN Alpha-2a Therapy in Part 2|Dosing discontinuation is defined as the occurrence of stopping the medication. Dosing discontinuation of Peg-IFN alpha-2a therapy was assessed up to 48 weeks in Part 2|From Antiviral Baseline up to Week 48 in Part 2|FAS2 Population. Only those particpants who received Peg-IFN alpha-2a antiviral therapy were analyzed.||Participants|||Number
675680|NCT01636778|Secondary|Number of Participants Who Discontinued Antiviral Therapy in Part 2|Dosing discontinuation is defined as the occurrence of stopping the medication. Dosing discontinuation of Antviral Therapy was assessed up to 48 weeks in Part 2|From Antiviral Baseline up to Week 48 in Part 2|FAS2 Population.||Participants|||Number
675681|NCT01636778|Secondary|Time to First Dose Reduction of Antiviral Therapy in Part 2|Time to first dose reduction was calucated as the time period from the first dose to the first dose reduction.|From Antiviral Baseline up to Week 48 in Part 2|FAS2 Population.||weeks||Standard Deviation|Mean
675682|NCT01636778|Secondary|Number of Participants With the Indicated Levels of RBV Therapy Dose Reductions in Part 2|Participants were assigned a score equal to the number of times their RBV dose of antiviral therapy was reduced (0=no DRs; 1=one DR; 2=two DRs; 3=three DRs; >3=more than three DRs). Where possible, every effort was made to maintain the recommended dose of antiviral therapy. However, where dose modification of antiviral therapy was required due to safety concerns, it was performed by the Investigator as per the region-specific product labels of RBV|From Antiviral Baseline up to Week 48 in Part 2|FAS2 Population.||Participants|||Number
675683|NCT01636778|Secondary|Number of Participants With the Indicated Levels of Peg-IFN Alpha-2b Therapy Dose Reductions in Part 2|Participants were assigned a score equal to the number of times their Peg-IFN alpha-2b dose of antiviral therapy was reduced (0=no dose reductions [DRs]; 1=one DR; 2=two DRs; 3=three DRs; >3=more than three DRs). Where possible, every effort was made to maintain the recommended dose of antiviral therapy. However, where dose modification of antiviral therapy was required due to safety concerns, it was performed by the Investigator as per the region-specific product labels of Peg-IFN.|From Antiviral Baseline up to Week 48 in Part 2|FAS2 Population. Only those particpants who met the criteria for antiviral therapy dose reduction of Peg-IFN alpha-2b were analyzed.||Participants|||Number
675684|NCT01636778|Secondary|Number of Participants With the Indicated Levels of Peg-IFN Alpha-2a Therapy Dose Reductions in Part 2|Participants were assigned a score equal to the number of times their Peg-IFN alpha-2a dose of antiviral therapy was reduced (0=no dose reductions [DRs]; 1=one DR; 2=two DRs; 3=three DRs; >3=more than three DRs). Where possible, every effort was made to maintain the recommended dose of antiviral therapy. However, where dose modification of antiviral therapy was required due to safety concerns, it was performed by the Investigator as per the region-specific product labels of Peg-IFN.|From Antiviral Baseline up to Week 48 in Part 2|FAS2 Population. Only those particpants who met the criteria for antiviral therapy dose reduction of Peg-IFN alpha-2a were analyzed.||Participants|||Number
675685|NCT01636778|Secondary|Number of Antiviral Therapy Dose Reductions in Part 2|Number of reductions in Part 2 of either Peg-IFN or RBV. Participants were assigned a score equal to the number of times antiviral therapy was reduced (0=no dose reductions [DRs]; 1=one DR; 2=two DRs; 3=three DRs; >3=more than three DRs). Where possible, every effort was made to maintain the recommended dose of antiviral therapy. However, where dose modification of antiviral therapy was required due to safety concerns, it was performed by the Investigator as per the region-specific product labels of Peg-IFN and/or RBV.|From Antiviral Baseline up to Week 48 in Part 2|FAS2 Population.||Participants|||Number
675686|NCT01636778|Secondary|Dose of Eltrombopag That Enabled Initiation of Antiviral Therapy|Participants received eltrombopag at escalating dosages until a platelet count of >=100 Gi/L was achieved in Part 1. Platelet counts were measured by blood draw.|From Baseline up to Week 9 in Part 1|FAS1 Population: all participants enrolled in Part 1.||Participants|||Number
675687|NCT01636778|Secondary|Minimum Platelet Count on Antiviral Therapy|"Participants were assessed for platelet counts during antiviral therapy in Part 2.
Platelet counts were measured by blood draw."|From Antiviral Baseline to up to Week 48 in Part 2|FAS2 Population: all participants enrolled in Part 2.||Participants|||Number
675688|NCT01636778|Secondary|Median Platelet Count at the Indicated Time Points During Follow-up Period After Part 2|Platelet counts were measured by blood draw at specified timepoints.|Follow-up (FU) Baseline, FU Week 4, FU Week 12 and and FU Week 24 after Part 2|FAS2 Population. Participants with any antiviral drugs during follow-up period after Part 2 are excluded from this analysis.||Gi/L||Full Range|Median
675689|NCT01636778|Secondary|Median Platelet Count at the Indicated Time Points in Part 2|Platelet counts were measured by blood draw|Antiviral Baseline, Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, Withdrawal in Part 2|FAS2 Population.||Gi/L||Full Range|Median
675692|NCT01636778|Primary|Number of Participants Whose Platelet Counts Maintained at >=50 Gi/L During Part 2|"Participants were assessed for continuously maintaining platelet counts >=50 Gi/L during Part 2.
Platelet counts were measured by blood draw."|From Antiviral Baseline to up to Week 48 in Part 2|Full Analysis Set 2 (FAS2) Population: all participants enrolled in Part 2.||Participants|||Number
675693|NCT01636778|Primary|Number of Participants Whose Platelet Count Increased From a Baseline Count of < 80 Gi/L to a Count >=100 Gi/L During Part 1|Participants were assessed for a shift from a baseline platelet count of <80 Gi/L to a count >=100 Gi/L during Part 1(up to 9 weeks). Platelet counts were measured by blood draw.|From Baseline up to Week 9 in Part 1|Full Analysis Set 1 (FAS1) Population: all participants enrolled in Part 1.||Participants|||Number
675694|NCT01636765|Primary|Intra-rater Reliability of the CEA Scale|Intra-rater (within raters) agreement of the CEA scores (0=clear skin with no signs of erythema; 1=almost clear of erythema, slight redness; 2=mild erythema, definite redness; 3=moderate erythema, marked redness; 4=severe erythema, fiery redness) was evaluated by weighted Kappa statistics (WKS). WKS were calculated for each of 7 raters who evaluated 104 participant's severity of erythema of rosacea using the CEA scale, assessing agreement between 2 different time points at day 1. The overall intra-rater agreement for WKS for all raters combined was estimated by pooling WKS for each rater using a chi-square statistic. The degree of agreement of the point estimates of WKS was interpreted according to the reference range scale that was predefined as: ≤ 0=poor, 0.00-0.20=slight, 0.21-0.40=fair, 0.41-0.60=moderate, 0.61-0.80=substantial and 0.81-1.00=almost perfect. The 95% confidence interval for Kappa statistics was provided.|Day 1|All enrolled participants.||Kappa statistics||95% Confidence Interval|Mean
675695|NCT01636765|Primary|Inter-rater Reliability of the Clinician Erythema Assessment (CEA) Scale|Inter-rater agreement (among raters) of the CEA scores (0=clear skin with no signs of erythema; 1=almost clear of erythema, slight redness; 2=mild erythema, definite redness; 3=moderate erythema, marked redness; 4=severe erythema, fiery redness) evaluated using Kendall’s coefficient of concordance (Kendall’s W). Each of 7 raters scored 104 participant's severity of erythema due to rosacea using the CEA Scale at 2 different time points at day 1. The overall inter-rater agreement for Kendall’s W for all raters combined was estimated based on the average of the scores from those 2 different time points. The degree of agreement of the point estimates of Kendall’s W was interpreted according to the reference range scale that was pre-defined as: ≤ 0=poor, 0.00-0.20=slight, 0.21-0.40=fair, 0.41-0.60=moderate, 0.61-0.80=substantial and 0.81-1.00=almost perfect. The 95% confidence interval for Kendall’s W was provided.|Day 1|All enrolled participants.||Kendall's W||95% Confidence Interval|Mean
675696|NCT01636713|Secondary|Change From Baseline Weighted Mean (WM) 0-6 Hour FEV1 Obtained Post-dose at Day 1|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The WM FEV1 was derived by calculating the area under the FEV1/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. The WM was calculated using the 0-6-hour post-dose FEV1 measurements collected on Day 1, which included pre-dose (30 minutes [min] and 5 min prior to dosing) and post-dose at 15 min, 30 min, 1 hour, 3 hours, and 6 hours. Change from Baseline at Day 1was calculated as the WM at post -dose value on Day 1 minus Baseline (mean of the two assessments made 30 min and 5 min pre-dose on Day 1). Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, Baseline FEV1 (mean of the two assessments made 30 and 5 minutes pre-dose on Day 1), smoking status, and country/region.|Baseline and Day 1|Intent-to-Treat (ITT) Population: all par. randomized to trt. who received at least one dose of randomized study drug. Par. represents those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis.||Liters||Standard Error|Least Squares Mean
675697|NCT01636713|Secondary|Transition Dyspnea Index (TDI) Focal Score at Day 168 (Week 24)|The TDI is an interviewer-administered instrument which measures the changes in the participant's dyspnea from Baseline. This questionnaire was collected on Days 28, 84 and 168. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI scores ranged from -3 (major deterioration) to +3 (major improvement); total score = -9 to 9. Analysis was performed using a repeated measures model with covariates of treatment, Baseline dyspnea index (BDI) focal score, smoking status, country/region, day, day by Baseline dyspnea index (BDI) focal score and day by treatment interactions.|Day 168 (Week 24)|Intent-to-Treat (ITT) Population: all par. randomized to trt. who received at least one dose of randomized study drug. Par. represents those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis.||Scores on a scale||Standard Error|Least Squares Mean
675698|NCT01636713|Primary|Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 169 (Week 24)|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 measurements were taken electronically by spirometry on Days 2, 28, 56, 84, 112, 168, and 169. Baseline is defined as the mean of the assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1. Trough FEV1 is defined as the mean of the FEV1 values obtained at 23 and 24 hours after the previous morning's dosing (ie., trough FEV1 on Day 169 is the mean of the FEV1 values obtained 23 and 24 hours after the morning dosing on Day 168). Change from Baseline at a particular visit was calculated as the trough FEV1at that visit minus Baseline. Analysis was performed using a repeated measures model with covariates of treatment, Baseline, smoking status, country/region, day, day by Baseline and day by treatment interactions. par.=participants.|Baseline and Day 169|Intent-to-Treat (ITT) Population: all par. randomized to trt. who received at least one dose of randomized study drug. Par. represents those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis.||Liters||Standard Error|Least Squares Mean
675699|NCT01636661|Secondary|Hand Function Decline as Measured by Number of Participants|Measured by the Box and Blocks Test and Grip Strength|Baseline, Posttest, Follow-Up Session at One-Week|||participants|||Number
675848|NCT01634152|Secondary|Peak Expiratory Flow (PEF) p.m. Change From Baseline|"Change from baseline in the evening (p.m.) peak expiratory flow based on the weekly mean at week 12.
Measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||L/min||Standard Error|Mean
675700|NCT01636661|Primary|Adverse Events/Safety Assessment.|"Assessment of safety of use of tDCS in children with hemiparesis through vital signs, physician evaluation, subject report of symptoms. Reported are the number of participants who met the following criteria:
Vital Signs (either resting blood pressure or heart rate)- Any greater than 2SD of change in vital signs from pretest to posttest.
Physician Evaluation- Child identified as declining in function from pretest to posttest.
Subject Report of Symptoms- Reports of serious adverse event/symptoms from pretest to posttest.
Detailed adverse events are reported in the adverse events module."|Baseline, Posttest, Follow-Up Session at One-Week|Pilot study therefore no sample size analysis. Completed per protocol.||Participants|||Number
675701|NCT01636466|Secondary|Incidence of Return to Dialysis Dependence||36 months||||||
675702|NCT01636466|Primary|Mean Fluorescence Index (MFI) of Donor Specific Alloantibodies (DSA)|Development of new donor-specific alloantibody as determined by solid phase bead array (Luminex) technology defining MFIs for fine specificity at Class I and Class II antigens (human leukocyte antigens (HLA) - A, B, C, DR, DP, and DQ) with an MFI >5000 defined as positive|36 months|Single subject enrolled was terminated early. No data analysis occurred.|||||
675703|NCT01636414|Primary|Change in Hemoglobin Level|Change in hemoglobin following surgery. Initial (baseline) measure was prior to surgery on day of surgery. Follow-up measurement occurred the day following surgery.|Post-operative on day 2 (first day after surgery)|||g/dl||Inter-Quartile Range|Median
675704|NCT01636414|Primary|Blood Transfusion|Transfusion Rate (i.e, number of participants needing Blood Transfusion) Between Treatment Groups|Inpatient Postoperative, on average 3 days after surgery|||participants|||Number
675705|NCT01636362|Secondary|Percent of Study Burn Healed.|Percent of study burn healed measured by PictZar photo analysis of tissue types.|At day 21|||percentage of healing||Full Range|Median
675706|NCT01636362|Primary|Proportion of Subjects Healed at Day 21.|The proportion of subjects healed will be assessed at day 14. Wounds not healed at day 14 will be assessed again at day 21.|Healing will be assessed after 21 days.|||participants|||Number
675707|NCT01636362|Primary|Number of Subjects Healed at Day 14.|> = 95 % epitheliazation|Healing will be assessed after 14 days.|||participants|||Number
675708|NCT01636258|Secondary|Sleep|Change in self-reported average hours of sleep/night measured at baseline and followup (at 8-14 weeks).|baseline and followup visit (at 8-14 weeks)|||hours/night||Inter-Quartile Range|Mean
675709|NCT01636258|Secondary|Stress|Change of Psychosocial Stress (PSS-10) scores (total range 0-40) measured at baseline and followup (at 8-14 weeks). Higher score reflects worse outcome.|baseline and followup visit (at 8-14 weeks)|||scores on a scale||Inter-Quartile Range|Mean
675710|NCT01636258|Secondary|Exercise|Change in 7-day average steps/day as measured by pedometer at baseline and followup (at 8-14 weeks).|Baseline and final followup visits (at 8-14 weeks)|||steps/day||Inter-Quartile Range|Mean
675711|NCT01636258|Secondary|Diet - Daily Calorie Intake|Change in daily caloric intake as measured by online 24-hour recall dietary program|Baseline and final followup visit (at 8-14 weeks)|||Kcal/day||Inter-Quartile Range|Mean
675712|NCT01636258|Primary|"Effect of FRESH Program on Weight Loss"|Change in weight measured at baseline and followup (at 8-14 weeks).|Baseline line and final followup visit (at 8-14 weeks)|||kg||Standard Deviation|Mean
675713|NCT01636206|Primary|Number of Participants With Ocular and Nonocular Treatment Emergent Adverse Events (TEAEs) for 1 Year||Day 0 to Day 360|Safety population included all randomized participants who received at least 1 dose of investigational product.||participants|||Number
675714|NCT01636102|Secondary|Numbers of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 – Day 4 Postvaccination)|Safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 up to and including day 4 after the TIV vaccination.|From day 1 through day 4 postvaccination|Analysis was done on the safety dataset i.e. the subjects in the exposed population who provided postvaccination safety data.||Number of subjects|||Number
675715|NCT01636102|Primary|Percentage of Subjects Who Achieved SRH Area ≥25 mm2 Against Each of Three Vaccine Strains After One Vaccination of TIV|"Immunogenicity was measured as the percentage of subjects achieving SRH area ≥25 mm2 against each of three vaccine strains at baseline (day 1) and three weeks after TIV vaccination (day 22).
This criterion was met according to CHMP guideline if percentage of subjects achieving SRH area ≥25 mm2 is >70% (≥18 years to ≤60) or 60% (≥61 years)."|Day 1 and 22|Analysis was done on the PP set.||Percentages of subjects||95% Confidence Interval|Number
675716|NCT01636102|Primary|Geometric Mean Ratio of Subjects Against Each of Three Vaccine Strains After One Vaccination of TIV|"Geometric mean ratio (GMR) of subjects was calculated as the ratio of postvaccination to prevaccination SRH geometric mean areas (GMAs), directed against each of three vaccine strains, three weeks after vaccination (day 22).
The CHMP criterion was met if the geometric mean increase (GMR, day 22/day 1) in SRH antibody area is >2.5 (≥18 years to ≤60 years) or >2.0 (≥61 years)."|Day 22|Analysis was done on the PP set.||Ratio||95% Confidence Interval|Number
675717|NCT01636102|Primary|Percentage of Subjects Who Achieved Seroconversion or Significant Increase in SRH Area Against Each of Three Vaccine Strains After One Vaccination of TIV|"Immunogenicity was measured as the percentage of subjects who achieved seroconversion or significant increase in single radial hemolysis (SRH) area, against each of three vaccine strains, three weeks after vaccination (day 22), evaluated using SRH assay.
Seroconversion or significant increase in SRH area was defined as the percentage of subjects with a negative prevaccination serum (SRH area ≤4 mm2) to a postvaccination SRH area ≥25 mm2; or a significant increase in antibody titer from a non-negative prevaccination serum, i.e., at least a 50% increase in area. The European (CHMP) criterion is met if percentage of subjects achieving seroconversion or significant increase in SRH area is >40% (≥18 years to ≤60 years) or 30% (≥61 years)."|Day 22|Analysis was done on the per-protocol (PP) set, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis.||Percentages of subjects||95% Confidence Interval|Number
675718|NCT01636076|Secondary|Pharmacokinetic Parameter--AUC0-t|Area under the plasma concentration time curve from time zero to time “t” post-dose is to be measured in a subset of approximately 60 patients via central laboratory, and will be determined for indacaterol and MF following morning dosing on Days 28 and 84.|Day 28, 84|Moderate PK set: A total of 97 (15.4%) patients were included in the 24 h profiling FAS, safety plasma cortisol profiling subgroup, sparse and moderate PK sets.||hr*pg/mL||Standard Deviation|Mean
675719|NCT01636076|Secondary|Pharmacokinetic Parameter--Tmax|Time to reach the maximum plasma concentration after drug administration is to be measured in a subset of approximately 60 patients via central laboratory, and will be determined for indacaterol and MF following morning dosing on Days 28 and 84.|Day 28, 84|Moderate PK set: A total of 97 (15.4%) patients were included in the 24 h profiling FAS, safety plasma cortisol profiling subgroup, sparse and moderate PK sets.||Hr||Full Range|Median
675720|NCT01636076|Secondary|Pharmacokinetic Parameter: Cmax|Maximum observed plasma concentration after drug administration is to be measured in a subset of approximately 60 patients via central laboratory, and will be determined for indacaterol and MF following morning dosing on Days 28 and 84.|Day 28, 84|Moderate PK set: A total of 97 (15.4%) patients were included in the 24 h profiling FAS, safety plasma cortisol profiling subgroup, sparse and moderate PK sets.||pg/mL||Standard Deviation|Mean
675721|NCT01636076|Secondary|Plasma Drug Concentrations (Pharmacokinetics) at Each Timepoint|Plasma indacaterol and mometasone furoate is to be measured in a subset of approximately 60 patients via central laboratory. Blood samples are collected at pre-dose on Day 1, 29, and 84; and post dose up to 4 hour on Day 1, up to 12 hours on Day 28 and 84. For sparse pharmacokinetic testing, blood samples will be collected at 23h 35 min post-dose following morning dose administration on Day 28 and 84, in all patients participating in this study.|Day 1, 29, 84|Moderate PK set: A total of 97 (15.4%) patients were included in the 24 h profiling FAS, safety plasma cortisol profiling subgroup, sparse and moderate PK sets.||pg/mL||Standard Deviation|Mean
675722|NCT01636076|Secondary|Plasma Cortisol Concentrations at Each Timepoint|Plasma cortisol to be measured in a subset of approximately 60 patients via central laboratory. Blood sample for Plasma cortisol is collected at pre-dose and post dose up to 4 hour on Day 1, up to 12 hours post-dose on Day 28 and Day 84, and 23 hour 35 minute on Day 2, Day 29, and Day 85, and at pre-dose 25 minute on Day 28, and Day 84.|Day 1, Day 28, Day 84|Safety set: A total of 97 (15.4%) patients were included in the 24 h profiling FAS, safety plasma cortisol profiling subgroup, sparse and moderate PK sets.||nmol/mL||Standard Deviation|Mean
675723|NCT01636076|Secondary|Total Amount (in Doses) of Systemic Corticosteroid Used to Treat COPD Exacerbation During the 12 Week Treatment Period|Total amount (in doses) of systemic corticosteroid used to treat COPD exacerbation will be summarized descriptively by treatment group per each systemic corticosteroid.|12 weeks|Full analysis set consisting of all randomized patients||(Prednisolone dose equivalents) mg||Standard Deviation|Mean
675724|NCT01636076|Secondary|The Percentage of Patients Who Permanently Discontinued Due to COPD Exacerbation|Time-to-event variables will be analyzed by the Kaplan-Meier estimates and the stratified Cox proportional hazard model by smoking status and COPD severity. The model will include treatment and country as factors, and FEV1 prior to inhalation and FEV1 15 min post inhalation of salbutamol/albuterol as covariates.|12 weeks|Full analysis set consisting of all randomized patients||Percentage participants|||Number
675725|NCT01636076|Secondary|Time (in Days) to Permanent Study Discontinuation Due to COPD Exacerbation|Time-to-event variables will be analyzed by the Kaplan-Meier estimates and the stratified Cox proportional hazard model by smoking status and COPD severity. The model will include treatment and country as factors, and FEV1 prior to inhalation and FEV1 15 min post inhalation of salbutamol/albuterol as covariates.|12 weeks|Full analysis set consisting of all randomized patients||Days||Inter-Quartile Range|Median
675726|NCT01636076|Secondary|Percentage of Patients With at Least One Exacerbation up to Week 12|Time-to-event variables will be analyzed by the Kaplan-Meier estimates and the stratified Cox proportional hazard model by smoking status and COPD severity. The model will include treatment and country as factors, and FEV1 prior to inhalation and FEV1 15 min post inhalation of salbutamol/albuterol as covariates. The reported measure will detail the percentage of participants that had an exacerbation up to week 12. Less exacerbations reflect a better outcome.|12 weeks|Full analysis set consisting of all randomized patients||Percentage of participants|||Number
675727|NCT01636076|Secondary|Duration (in Days) of COPD Exacerbations|Duration and number of the COPD exacerbation will be analyzed by the negative binomial regression model including treatment, country, smoking status, and COPD severity as factors and FEV1 prior to inhalation and FEV1 15 min post inhalation of salbutamol/albuterol as covariates.|12 weeks|Full analysis set consisting of all randomized patients||Days||Standard Deviation|Mean
675728|NCT01636076|Secondary|Annual Rate of COPD Exacerbations|Time-to-event variables will be analyzed by the Kaplan-Meier estimates and the stratified Cox proportional hazard model by smoking status and COPD severity. The model will include treatment and country as factors, and FEV1 prior to inhalation and FEV1 15 min post inhalation of salbutamol/albuterol as covariates.|12 weeks|Full analysis set consisting of all randomized patients||COPD Exacerbations per year||95% Confidence Interval|Number
675729|NCT01636076|Secondary|Time to First COPD Exacerbation|Time-to-event variables will be analyzed by the Kaplan-Meier estimates and the stratified Cox proportional hazard model by smoking status and COPD severity. The model will include treatment and country as factors, and FEV1 prior to inhalation and FEV1 15 min post inhalation of salbutamol/albuterol as covariates. The reported measure will detail the percentage of participants that were event free of a specified event.|12 weeks|Full analysis set consisting of all randomized patients||Percentage of participants event free||95% Confidence Interval|Number
675730|NCT01636076|Secondary|Summary Statistics of COPD Exacerbations over12 Weeks as Defined by Chronic Pulmonary Disease Tool (EXACT)|The EXACT is a 14-item electronic questionnaire designed to detect the frequency, severity, and duration of exacerbations in patients with COPD.|12 weeks|Full analysis set consisting of all randomized patients||COPD exacerbation per participant||Standard Deviation|Mean
675731|NCT01636076|Secondary|Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Sleep Quantity Subscale|The sleep quantity subscale,which refers to question 2 of the PRO: On average, how many hours did you sleep each night during the past 4 weeks. More hours of sleep indicate better outcome.|Baseline, 4 and 12 weeks|Full analysis set.Higher scores show better outcomes.Excepting the sleep quantity subscale,scoring the MOS requires two steps:(a) assigning a point value to each response and (b) summing the point values for all the items in a given subscale or index. Each subscale and index score is then converted to a T score with a mean of 50 and an SD of 10.||hours of sleep||Standard Deviation|Mean
675927|NCT01633853|Primary|The Blood Levels of Calcium at the 24th Month of Following up.|The blood levels of calcium at the 24th month of following up will be detected.|24 months|||mmol/L||Standard Deviation|Mean
675732|NCT01636076|Secondary|Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Without Quantity Subscale|"Scoring the MOS Sleep Survey is a two-step process:• All items are scored so that a high score reflects more of the attribute implied by the scale name. Each item is converted to a 0 to 100 possible range so that the lowest and highest possible scores are set at 0 and 100, respectively. In this format, scores represent the achieved percentage of the total possible score. For example, a score of 50 represents 50% of the highest possible score.
• Second, items within each scale are averaged together to create the 7 scale scores. Scales with at least one item answered can be used to generate a scale score. Items that are left blank (missing data) are not taken into account when calculating the scale scores. Scores represent the average for all items in the scale that the respondent answered. An additional measure is based on the average number of hours sleep each night during the past 4 weeks and are described in outcome measure 15."|Baseline, 4 and 12 weeks|Full analysis set.||Units on a scale||Standard Deviation|Mean
675733|NCT01636076|Secondary|Patient Reported Outcome Measures: COPD Assessment Test|It consists of eight items, each presented as a semantic 6-point differential scale, providing a total score out of 40. A higher score indicates a worse health status. Scores of 0 - 10, 11 - 20, 21 - 30 and 31 - 40 represent a mild, moderate, severe or very severe clinical impact of COPD upon the patient.|Baseline, 4 and 12 weeks|Full analysis set consisting of all randomized patients||Units on a scale||Standard Deviation|Mean
675734|NCT01636076|Secondary|Analysis of the Proportion of Subjects With a Clinically Important Improvement of >=1 Point in the TDI (Transitional Dyspnoea Index)Focal Score by Visit|A TDI focal score of ≥1 is considered to be a clinically important improvement from baseline. Analysis of the proportion of subjects with a clinically important improvement of >=1 point in the TDI focal score, by visit|4 and 12 weeks|Full analysis set, All randomized patients. When data were missing or insufficient for any one of the domains a focal score could not be calculated.||(%) showing clinical improvement|||Number
675735|NCT01636076|Secondary|Patient Reported Outcome Measures: SGRQ (St. George’s Respiratory Questionnaire)|A Total and three component scores are calculated: Symptoms; Activity; Impacts. Each component of the questionnaire is scored separately:The score for each component is calculated separately by dividing the summed weights by the maximum possible weight for that component and expressing the result as a percentage: Score = 100 x Summed weights from all positive items in that component divided by Sum of weights for all items in that component The Total score is calculated in similar way: Score = 100 x Summed weights from all positive items in the questionnaire divided by Sum of weights for all items in the questionnaire Sum of maximum possible weights for each component and Total: Symptoms 566.2 Activity 982.9 Impacts 1652.8 Total (sum of maximum for all three components) 3201.9 The proportion of patients who achieve a clinically important improvement of at least 4 units in the total SGRQ will be analyzed. The higher the score the more symptoms of disease are present.|4 and 12 weeks|Full analysis set : At baseline all subjects with a baseline value are included. At each post-baseline day, only subjects with a value at both baseline and the respective day are included. Baseline SGRQ was completed on Day 1 prior to first dose.||Total Score||Standard Deviation|Mean
675736|NCT01636076|Secondary|The Overall Change in Usage of Rescue Medication (Short Acting β2-agonist) .|This value represents the percent of days in the study where no rescue medication was needed.|Baseline to 12 weeks|Full analysis set consisting of all randomized patients||% of days||Standard Error|Least Squares Mean
675737|NCT01636076|Secondary|The Usage of Rescue Medication (Short Acting β2-agonist)|Participants record the number of puffs of rescue medication taken in the previous 12 hours each morning and evening throughout the 12 week treatment period.|12 weeks|Full analysis set consisting of all randomized patients||Number of puffs||Standard Error|Least Squares Mean
675738|NCT01636076|Secondary|Mixed Model for Repeated Measures (MMRM): Between-treatment Comparisons for AUC (5 Min – 23 h 45 Min) for FEV1 (L) on Day 28 and Day 84 (Full Analysis Set, 24-h Profiling Subgroup)|Spirometry is conducted according to the global standard. FEV1 AUC (5 min-4 h), (5 min-24 h) is measured after the first dose on Day 1 and on Day 28 and Day 84 in a subset of approximately 60 patients. Scheduled (not actual) time points are to be used. The interpretation of FEV1 at time 0 is the baseline value at the randomization visit and the latest pre-dose value (-50 min or -15 min) at subsequent visits. The standardized AUC(5 min – 4 h) for FEV1 will be summarized by treatment. The same will be repeated for standardized AUC for FEV1 between 5 min and 24 hours post morning dose.|Day 28, Day 84|Peak FEV1 was calculated for all subjects in the FAS at Day 1 (Visit 201) and was calculated for all subjects in the 24-h profiling subset of the FAS at Day 1 (Visit 201), Day 28 (Visit 203) and Day 84 (Visit 205).||Liters*hours||Standard Error|Least Squares Mean
675739|NCT01636076|Secondary|FEV1 AUC (5 Min-4 h),|Spirometry is conducted according to the global standard. FEV1 AUC (5 min-4 h), (5 min-24 h) is measured after the first dose on Day 1 and on Day 28 and Day 84 in a subset of approximately 60 patients. Scheduled (not actual) time points are to be used. The interpretation of FEV1 at time 0 is the baseline value at the randomization visit and the latest pre-dose value (-50 min or -15 min) at subsequent visits. The standardized AUC(5 min – 4 h) for FEV1 will be summarized by treatment. The same will be repeated for standardized AUC for FEV1 between 5 min and 24 hours post morning dose.|Day 1(Baseline), Day 28, Day 84|24 hr profiling subgroup||Liters*hours||Standard Error|Least Squares Mean
675740|NCT01636076|Secondary|FEV1 (L) on Day 1 Between-treatment Comparisons of AUC (5min – 4h)|Spirometry is conducted according to the global standard. FEV1 AUC (5 min-4 h), Scheduled (not actual) time points are to be used. The standardized AUC(5 min – 4 h) for FEV1 will be summarized by treatment.|Day 1|Full analysis set consisting of all randomized patients||Liters * hours||Standard Error|Least Squares Mean
675741|NCT01636076|Secondary|FEV1/FVC at Each Timepoint|Spirometry is conducted according to the global standard. FEV1/FVC is measured at pre-dose and post dose up to 4 hour on Day 1, Day 28, and Day 84, at post dose 12 hour, 23 hour 10 minute and 23 hour 45 minutes on Day 2 and Day 29, and at pre-dose 50 min and 15 min on Day 2, Day 28, and Day 84.|Day 1, Day 2, Day 28, Day , Day 29, Day 84, Day 85|Full analysis set consisting of all randomized patients||FEV1/ FVC (%)||Standard Deviation|Mean
675742|NCT01636076|Secondary|Forced Vital Capacity (FVC) at Each Timepoint|Spirometry is conducted according to the global standard. FVC is measured at pre-dose and post dose up to 4 hour on Day 1, Day 28, and Day 84, at post dose 12 hour, 23 hour 10 minute and 23 hour 45 minutes on Day 2 and Day 29, and at pre-dose 50 min and 15 min on Day 2, Day 28, and Day 84.|Day 1, Day 2, Day 28, Day , Day 29, Day 84, Day 85|Full analysis set consisting of all randomized patients||liters||Standard Deviation|Mean
675744|NCT01636076|Secondary|Trough FEV1 After First Dose and After 4 Weeks of Treatment|Spirometry is conducted according to the global standard. FEV1 is measured at pre-dose and post dose up to 1 hours on Day 1 and Day 28; 24 hours post-dose on Day 29 and 85. In a subset of approximately 60 patients, FEV1 is measured up to 20 hours postdose on Day 28 and Day 84.|Day 1 and Day 85|All randomized patients were included in the Safety analysis set (SAF) and Full analysis set (FAS).||Liters||Standard Error|Mean
675745|NCT01636076|Primary|Mixed Model for Repeated Measures (MMRM): Between-treatment Comparisons for Trough FEV1 (L) on Day 85|Spirometry is conducted according to the global standard. Trough FEV1 is defined as the average of the 23 hour 10 minute and 23 hour 45 minute post dose FEV1 readings.|12 weeks|All randomized patients were included in the Full analysis set (FAS)||Liters||Standard Error|Least Squares Mean
675746|NCT01636063|Primary|Initial Cervical Dilation at the Time of Surgical Abortion|Initial cervical dilation as measured in French units by a Pratt cervical dilator prior to surgical abortion. The dilation was measured in French units with each French unit being equivalent to 0.33 mm.|24 to 48 hours after enrollment|||French units||Standard Deviation|Mean
675747|NCT01635933|Secondary|Proportion of Subjects Preferring Study Lens (Strongly or Somewhat)|Participants were asked to compare the study lenses to their habitual lenses using a 5-point scale: strongly prefer study lenses, somewhat prefer study lenses, no preference, somewhat prefer habitual lenses, and strongly prefer habitual lenses, where ‘study lenses’ refer to either test or control depending on the treatment group. Proportion of subjects preferring study lens is reported as the percentage of participants who strongly or somewhat preferred the study lens.|Day 28|The analysis population includes all enrolled and dispensed participants who had at least 1 study visit after being dispensed the study lenses. No imputation was used for missing values.||Percentage of participants|||Number
675748|NCT01635933|Secondary|Subjective Rating of Overall Vision|Overall vision, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.|Up to Day 28|The analysis population includes all enrolled and dispensed participants who had at least one study visit after being dispensed with study lenses (N=178,185). No imputation was used for the missing values. Here, “n” is the number of participants with non-missing values at the specific time point for each arm group.||Units on a scale||Standard Deviation|Mean
675749|NCT01635933|Primary|Subjective Rating of Overall Comfort|Overall comfort, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.|Up to Day 28|The analysis population includes all enrolled and dispensed participants who had at least one study visit after being dispensed with study lenses (N=178,185). No imputation was used for the missing values. Here, “n” is the number of participants with non-missing values at the specific time point for each arm group.||Units on a scale||Standard Deviation|Mean
675750|NCT01635920|Secondary|Subjective Rating of Overall Comfort|Overall comfort, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.|Up to Day 28|ITT: All enrolled and dispensed participants who had at least one study visit after being dispensed with study lenses (N=125,126). No imputation was used for the missing values. Here, “n” is the number of participants with non-missing values at the specific time point for each arm group, respectively.||units on a scale||Standard Deviation|Mean
675751|NCT01635920|Primary|Percentage of Subjects With Same Fit in Both Eyes|"Lens fit was assessed by the investigator for each eye using a biomicroscope (slit lamp), which magnifies the appearance of the contact lens on the participant's eye. Lens fit was graded on a 5-point scale, with 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight. Same fit was defined as an eye that achieved an acceptable or optimal overall lens fit with the study lens, that was also within one grade of the value observed on the same eye with the habitual lens at the baseline visit."|Up to Day 28|ITT: All enrolled and dispensed participants who had at least one study visit after being dispensed with study lenses (N=125,126). No imputation was used for the missing values. Here, “n” is the number of participants with non-missing values at the specific time point for each arm group, respectively.||percentage of participants|||Number
675752|NCT01635881|Secondary|In-hospital Major Adverse Cardiac Events (MACE)|"In-hospital MACE:
All death (cardiac and non-cardiac)
Myocardial infarction (MI)
Target Vessel Revascularization (TVR)
In-hospital Stent Thrombosis (ST) within the target vessel
Clinically significant arrhythmias (requiring intervention)"|Participants will be followed for the duration of hospital stay (an expected average of 24 hours)|Analysis population consists of intent-to-treat subject population.||percentage of participants||95% Confidence Interval|Number
675753|NCT01635881|Primary|Device Procedural Success|"Device procedural success consisting of the following:
Successful delivery, inflation, deflation and withdrawal of the study balloon.
No evidence of vessel perforation, flow limiting dissection (grade C or higher) or reduction in TIMI flow from baseline related to the study balloon.
Final TIMI flow grade of 3 at the conclusion of the percutaneous coronary intervention procedure"|Peri-procedural|Analysis population consists of intent-to-treat subject population.||percentage of participants||95% Confidence Interval|Number
675754|NCT01635855|Primary|Rate of Severe Common Adverse Events|The purpose of this study was to determine if the rate of “Severe” common adverse events after re-treatment with Belotero Balance differs from the combined rates reported in the Belotero® Balance IDE clinical trial and Belotero® Balance Fitzpatrick Skin Type IV-VI Study (Pre-Approval Studies).“Common” is defined as pre-specified adverse events occurring in >= 5% of study subjects. These averse events are: bruising, itching, pain, redness, swelling, discoloration, nodule, and induration.|1 month|||percentage of 'severe' common AEs||95% Confidence Interval|Number
675769|NCT01635764|Primary|Percentage of Participants in the EW/EW/EW, EW/EOW/EW, and EW/PBO/EW Analysis Populations Achieving Clinical Response Per Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit|Clinical response per HiSCR defined as percent reduction from baseline of the prior phase 3 study in the abscess and inflammatory nodule ≥ 50% (AN50) with no increase in the abscess count and no increase in the draining fistula count. Last Observation Carried Forward (LOCF): The last completed evaluation from the previous visit was carried forward to impute missing data at later visits.|Weeks 2 (first dose of adalimumab in prior phase 3 study), 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216|All participants with evaluable data at given time point.||percentage of participants|||Number
675755|NCT01635764|Primary|Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3|"The NRS was used to assess the worst skin pain and the average skin pain due to HS. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The assessments were completed on a daily diary by participants before they went to bed and responded to the items based on a recall period of the last 24 hours. The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline in the NRS (NRS30) - on average at each visit among participants with baseline skin pain NRS - on average ≥ 3 are presented. Weekly averages of daily assessments were analyzed. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits."|Entry of Period B in prior phase 3 study, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, and 204|All participants with baseline skin pain NRS - on average ≥ 3 and with evaluable data at given time point.||percentage of participants|||Number
675756|NCT01635764|Primary|Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3|"The NRS was used to assess the worst skin pain and the average skin pain due to HS. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The assessments were completed on a daily diary by participants before they went to bed and responded to the items based on a recall period of the last 24 hours. The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline in the NRS (NRS30) - on average at each visit among participants with baseline skin pain NRS - on average ≥ 3 are presented. Weekly averages of daily assessments were analyzed. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits."|Entry of M12-555, and Weeks 4, 8, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192|All participants with baseline skin pain NRS - on average ≥ 3 and with evaluable data at given time point.||percentage of participants|||Number
675757|NCT01635764|Primary|Percentage of Participants in the EW/EW/EW Analysis Population Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3|"The NRS was used to assess the worst skin pain and the average skin pain due to HS. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The assessments were completed on a daily diary by participants before they went to bed and responded to the items based on a recall period of the last 24 hours. The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline in the NRS (NRS30) - on average at each visit among participants with baseline skin pain NRS - on average ≥ 3 are presented. Weekly averages of daily assessments were analyzed. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits."|Weeks 2 (first dose of adalimumab in prior phase 3 study), 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192|All participants with baseline skin pain NRS - on average ≥ 3 and with evaluable data at given time point.||percentage of participants|||Number
675758|NCT01635764|Primary|Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3|"The NRS was used to assess the worst skin pain and the average skin pain due to HS. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The assessments were completed on a daily diary by participants before they went to bed and responded to the items based on a recall period of the last 24 hours. The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline in the NRS (NRS30) - at worst at each visit among participants with baseline skin pain NRS - at worst ≥ 3 are presented. Weekly averages of daily assessments were analyzed. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits."|Entry of Period B in prior phase 3 study, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, and 204|All participants with baseline skin pain NRS-at worst ≥3 and with evaluable data at given time point||percentage of participants|||Number
675759|NCT01635764|Primary|Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3|"The NRS was used to assess the worst skin pain and the average skin pain due to HS. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The assessments were completed on a daily diary by participants before they went to bed and responded to the items based on a recall period of the last 24 hours. The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline in the NRS (NRS30) - at worst at each visit among participants with baseline skin pain NRS - at worst ≥ 3 are presented. Weekly averages of daily assessments were analyzed. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits."|Entry of M12-555, and Weeks 4, 8, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192|All participants with baseline skin pain NRS-at worst ≥3 and with evaluable data at given time point||percentage of participants|||Number
675760|NCT01635764|Primary|Percentage of Participants in the EW/EW/EW Analysis Population Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3|"The Patient's Global Assessment of Skin Pain Numeric Rating Scale (NRS) was used to assess the worst skin pain and the average skin pain due to HS. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The assessments were completed on a daily diary by participants before they went to bed and responded to the items based on a recall period of the last 24 hours. The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline in the Patient's Global Assessment of Skin Pain (NRS30) - at worst at each visit among participants with baseline skin pain NRS - at worst ≥ 3 are presented. Weekly averages of daily assessments were analyzed. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits."|Weeks 2 (first dose of adalimumab in prior phase 3 study), 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192|All participants with baseline skin pain NRS-at worst ≥3 and with evaluable data at given time point||percentage of participants|||Number
675770|NCT01635504|Primary|Percentage Change in Volume of the Parotid Gland From Baseline to 12 Weeks After Treatment With Botulinum Toxin A||Baseline and 12 weeks|||percentage reduction in parotid volume||Full Range|Mean
675761|NCT01635764|Primary|Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the PBO/EW/EW Analysis Population|The Sartorius Scale is used to quantify the severity of HS. Points are awarded for 12 body areas (left and right axillae, left and right sub/inframammary areas, intermammary area, left and right buttocks, left and right inguino-crural folds, perianal area, perineal area, and other): points were awarded for nodules (2 points for each); abscesses (4 points); fistulas (4 points); scars (1 point); other findings (1 point); and longest distance between two lesions (2-6 points, 0 if no lesions); and if lesions are separated by normal skin (yes-0 points; no-6 points). The total Sartorius score is the sum of the 12 regional scores. Higher scores indicate greater severity of HS. A negative change indicates decrease in severity. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits.|Baseline (in prior phase 3 study) to Entry of Period B in prior phase 3 study and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, and 204|All participants with evaluable data at given time point.||units on a scale||Standard Deviation|Mean
675762|NCT01635764|Primary|Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations|The Sartorius Scale is used to quantify the severity of HS. Points are awarded for 12 body areas (left and right axillae, left and right sub/inframammary areas, intermammary area, left and right buttocks, left and right inguino-crural folds, perianal area, perineal area, and other): points were awarded for nodules (2 points for each); abscesses (4 points); fistulas (4 points); scars (1 point); other findings (1 point); and longest distance between two lesions (2-6 points, 0 if no lesions); and if lesions are separated by normal skin (yes-0 points; no-6 points). The total Sartorius score is the sum of the 12 regional scores. Higher scores indicate greater severity of HS. A negative change indicates decrease in severity. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits.|Baseline (in prior phase 3 study) to Entry of M12-555 and Weeks 4, 8, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192|All participants with evaluable data at given time point.||units on a scale||Standard Deviation|Mean
675763|NCT01635764|Primary|Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the EW/EW/EW Analysis Population|The Sartorius Scale is used to quantify the severity of HS. Points are awarded for 12 body areas (left and right axillae, left and right sub/inframammary areas, intermammary area, left and right buttocks, left and right inguino-crural folds, perianal area, perineal area, and other): points were awarded for nodules (2 points for each); abscesses (4 points); fistulas (4 points); scars (1 point); other findings (1 point); and longest distance between two lesions (2-6 points, 0 if no lesions); and if lesions are separated by normal skin (yes-0 points; no-6 points). The total Sartorius score is the sum of the 12 regional scores. Higher scores indicate greater severity of HS. A negative change indicates decrease in severity. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits.|Baseline (in prior phase 3 study) to Weeks 2 (first dose of adalimumab in prior phase 3 study), 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216|All participants with evaluable data at given time point.||units on a scale||Standard Deviation|Mean
675764|NCT01635764|Primary|Percentage of Participants in the PBO/EW/EW Analysis Population Who Achieved AN Count of 0, 1, or 2 at Each Visit|The percentage of participants with AN counts lowered to 0, 1, or 2 at each visit. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits.|Entry of Period B in prior phase 3 study, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, and 204|All participants with evaluable data at given time point.||percentage of participants|||Number
675765|NCT01635764|Primary|Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Who Achieved AN Count of 0, 1, or 2 at Each Visit|The percentage of participants with AN counts lowered to 0, 1, or 2 at each visit. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits.|Entry of M12-555, Weeks 4, 8, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192|All participants with evaluable data at given time point.||percentage of participants|||Number
675766|NCT01635764|Primary|Percentage of Participants in the EW/EW/EW Analysis Population Who Achieved Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2 at Each Visit|The percentage of participants with AN counts lowered to 0, 1, or 2 at each visit. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits.|Weeks 2 (first dose of adalimumab in prior phase 3 study), 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216|All participants with evaluable data at given time point.||percentage of participants|||Number
675767|NCT01635764|Primary|Percentage of Participants in the PBO/PBO/EW Analysis Population Achieving Clinical Response Per HiSCR at Each Visit|Clinical response per HiSCR defined as percent reduction from baseline of the prior phase 3 study in the abscess and inflammatory nodule ≥ 50% (AN50) with no increase in the abscess count and no increase in the draining fistula count. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits.|Entry of M12-555, Weeks 4, 8, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192|All participants with evaluable data at given time point.||percentage of participants|||Number
675768|NCT01635764|Primary|Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Clinical Response Per HiSCR at Each Visit|Clinical response per HiSCR defined as percent reduction from baseline of the prior phase 3 study in the abscess and inflammatory nodule ≥ 50% (AN50) with no increase in the abscess count and no increase in the draining fistula count. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits.|Entry of Period B in prior phase 3 study, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, and 204|All participants with evaluable data at given time point.||percentage of participants|||Number
675771|NCT01635504|Primary|Percentage Change in Volume of the Masseter Muscle From Baseline to 12 Weeks After Treatment With Botulinum Toxin A||Baseline and 12 weeks|||percentage reduction in masseter volume||Full Range|Mean
675772|NCT01635439|Secondary|Normal Vaginal Delivery Rate||24 hours|||participants|||Number
675773|NCT01635439|Secondary|Need for Syntocinon Augmentation||24 hours|||participants|||Number
675774|NCT01635439|Secondary|Uterine Hyper-stimulation Rate||24 hours|||participants|||Number
675775|NCT01635439|Secondary|Induction to Onset of Labor Interval||24 hours|||hours||Standard Deviation|Mean
675778|NCT01635218|Secondary|Remission Rates at 6 Weeks|17-item Hamilton Rating Scale for Depression is a well-known standardized scale used worldwide to assess severity of depression. Score ranges from 0 (no depression) up to 52 (maximum depression severity). A total score in 17-item Hamilton Scale for Depression was assessed for this study. It ranges from 0 (no depression) up to 52 (most severe depression). A score < or = 7 is considered normal, 7 - 13 (mild depression), 14 - 24 (moderate to severe depression), > 24 (severe depression). Remission rate definition: 17-item Hamilton Rating Scale for Depression score < 7 points after 6 weeks of treatment.|6 weeks|All patients under randomization were included in the primary efficacy population (intention-to-treat population) regardless whether or not they adhered to the treatment protocol or provided complete data sets.||participants with a score of < 7 in HS|||Number
675779|NCT01635218|Secondary|Change From Baseline in Greene´s Scale at 6 Weeks.|Greene Climacteric Scale (GS) is intended to be a standard measure of core climacteric symptoms. For this study a total range was assessed at baseline and after six weeks of treatment. A total score 0 (without climacteric symptoms) up to 63 (most severe climacteric symptoms). The change was calculated as the later time point (total score in GS at 6 weeks) minus the earlier time point (total score at baseline).The scale measures four separate sub-scales (anxiety, depression, somatic symptoms and sexual function). The score of the four sub-scales was summed. A total score of 0 -10 is considered without symptoms, 11 - 29 (mild symptoms), 30 - 49 (moderate symptoms) and > 50 (severe symptoms).|Baseline and 6 weeks|All patients under randomization were included in the primary efficacy population (intention-to-treat population) regardless whether or not they adhered to the treatment protocol or provided complete data sets.The mean and SD presented here in the Outcome measure data table are the final scores after 6 weeks treatment.||Units in Green Scale||Standard Deviation|Mean
675780|NCT01635218|Secondary|Responder Rates at 6 Weeks.|17-item Hamilton Rating Scale for Depression is a well-known standardized scale used worldwide to assess severity of depression. Score ranges from 0 (no depression) up to 52 (maximum depression severity). A total score in 17-item Hamilton Scale for Depression was assessed for this study. It ranges from 0 (no depression) up to 52 (most severe depression). A score < or = 7 is considered normal, 7 - 13 (mild depression), 14 - 24 (moderate to severe depression), > 24 (severe depression). Responder rate definition: a decrease of 50% or more from baseline score using 17-item Hamilton Rating Scale for Depression after six weeks treatment.|6 weeks|All patients under randomization were included in the primary efficacy population (intention-to-treat population) regardless whether or not they adhered to the treatment protocol or provided complete data sets.||participants with a decrease >50% in HS|||Number
675781|NCT01635218|Secondary|Change From Baseline in Beck Depression Inventory at 6 Weeks.|Beck Depression Inventory (BDI) is a 21-question multiple-choice self-report inventory that assess severity of depression. A total score range was assessed at baseline and after six weeks of treatment. A score 0 (without depression) up to 63 (most severe depression). For this study the change was calculated as the later time point (total score in BDI at 6 weeks) minus the earlier time point (total score in BDI at baseline). A score 0 - 8 is considered normal, 9 - 18 (mild to moderate depression), 19 - 28 (moderate to severe depression), > 29 (severe depression).|Baseline and 6 weeks|All patients under randomization were included in the primary efficacy population (intention-to-treat population) regardless whether or not they adhered to the treatment protocol or provided complete data sets. The mean and SD presented here in the Outcome measure data table are the final scores after 6 weeks treatment.||Units in Beck Depression Inventory||Standard Deviation|Mean
675782|NCT01635218|Primary|Change From Baseline in 17-item Hamilton Rating Scale for Depression at 6 Weeks.|17-item Hamilton Rating Scale for Depression (HRSD) is a well-known standardized scale used worldwide to assess severity of depression. Score ranges from 0 (no depression) up to 52 (maximum depression severity). A total score in HRSD was assessed at baseline and after six weeks of treatment. For this study the change was calculated as the later time point (total score in 17- HRSD at 6 weeks) minus the earlier time point (total score at baseline). A score < or = 7 is considered normal, 7 - 13 (mild depression), 14 - 24 (moderate to severe depression), > 24 (severe depression).|Baseline and 6 weeks|All patients under randomization were included in the primary efficacy population (intention-to-treat population), regardless whether or not they adhered to the treatment protocol or provided complete data sets.The mean and SD presented in outcome measure data table are the final scores in Hamilton Scale after 6 weeks of treatment.||Units in Hamilton Scale||Standard Deviation|Mean
675783|NCT01635062|Secondary|Change in Urine Protein After Calcitriol/Placebo Therapy|Subjects have their urine protein assessed at baseline while sodium loaded and again 3 weeks after randomized therapy with calcitriol or placebo.|baseline and 3 weeks following calcitriol/placebo therapy|||mg/24h||Standard Deviation|Mean
675784|NCT01635062|Secondary|Change in Renal Plasma Flow After Calcitriol/Placebo Therapy|Subjects had their renal plasma flow assessed at baseline while sodium loaded, and again after 3 weeks of randomized therapy with either calcitriol (up to 0.75 mcg daily) or placebo.|baseline and 3 weeks following calcitriol/placebo therapy|||mL/min/1.73m2||Standard Deviation|Mean
675785|NCT01635062|Primary|The Change in Circulating RAS Activity After Calcitriol/Placebo Therapy|The below results represent the change in Plasma Renin Activity.|baseline and 2 weeks following calcitriol/placebo therapy|||ng/mL/h||Inter-Quartile Range|Median
675786|NCT01634854|Secondary|NICU Admission and APGAR Less Than 7 at 5 Minutes|NICU admission and APGAR less than 7 at 5 minutes|Through discharge from hospital|||Participants|||Count of Participants
675787|NCT01634854|Secondary|Number of Participants With Excessive Uterine Activity Necessitating Treatment|Number of patients receiving terbutaline during labor for uterine tachysytole|Measured from initiation of medication until delivery time|||Participants|||Count of Participants
675788|NCT01634854|Secondary|Maternal Satisfaction With Labor||6 weeks post-partum|data was not collected|||||
675789|NCT01634854|Secondary|Maternal Delivery Outcomes|Delivery outcomes|Through discharge from hospital|||Participants|||Count of Participants
675790|NCT01634854|Secondary|Neonatal Weight at Delivery|Neonatal Weight|Immediately following delivery|||grams||Inter-Quartile Range|Median
675791|NCT01634854|Secondary|Neonatal APGAR Scores|APGAR is a scoring system that evaluates Activity, Pulse, Grimace, Appearance, and Respiration. Each category is given a score of 0-2 points (with 0 being absent and 2 being normal), the points are then combined for a total score that ranges from 0-10. Scores 7 and above are generally normal, 4 to 6 are fairly low, and 2 and below are considered critically low.|At 1 minute and 5 minutes after delivery|||number||Inter-Quartile Range|Median
675793|NCT01634659|Secondary|End of Day Comfort|End of day comfort was interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 8 days of wear. End of day comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. Both eyes contributed to the mean.|Day 8|Per-Protocol: All participants completing the study and satisfying all of the inclusion/exclusion criteria, minus protocol deviations as determined by masked review.||Units on a scale||Standard Deviation|Mean
675794|NCT01634659|Secondary|Overall Quality of Vision|Overall quality of vision was interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 8 days of wear. Overall quality of vision was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. Both eyes contributed to the mean.|Day 8|Per-Protocol: All participants completing the study and satisfying all of the inclusion/exclusion criteria, minus protocol deviations as determined by masked review.||Units on a scale||Standard Deviation|Mean
675795|NCT01634659|Primary|Overall Comfort|Overall comfort was interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 8 days of wear. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. Both eyes contributed to the mean.|Day 8|Per-Protocol: All participants completing the study and satisfying all of the inclusion/exclusion criteria, minus protocol deviations as determined by masked review.||Units on a scale||Standard Deviation|Mean
675796|NCT01634620|Primary|Mean FeNO Levels by ICD 9 Code Category|Forced exhaled nitric oxide (FeNO) was measured using a NIOX MINO device. Based on medical history, subjects were given an International Statistical Classification of Diseases and Related Health Problems (ICD) code for concurrent diseases. Of interest, FeNO levels were characterized for subjects coded with chronic obstructive pulmonary disease (COPD) and Asthma, COPD and Emphysema, and then by all other concurrent diseases.|Single Visit|Per-protocol Population||parts per billion (ppb)||Standard Deviation|Mean
675797|NCT01634620|Primary|FeNO Levels by ICD 9 Code Category|Forced exhaled nitric oxide (FeNO) was measured using a NIOX MINO device. Subjects are categorized by low (<25 parts per billion or ppb), moderate (>=25 ppb or <=50 ppb), or high >50 ppb. Based on medical history, subjects were given an Internation Statistical Classification of Diseases and Related Health Problems (ICD) code for concurrent diseases. Of interest, FeNO levels were characterized for subjects coded with chronic obstructive pulmonary disease (COPD) and Asthma, COPD and Emphysema, and then by all other concurrent diseases.|Single Visit|Per-protocol Population||participants|||Number
675798|NCT01634620|Primary|FeNO Levels by Smoking Status|Forced exhaled nitric oxide (FeNO) was measured using a NIOX MINO device. Subjects are categorized by low (<25 parts per billion or ppb), moderate (>=25 ppb or <=50 ppb), or high >50 ppb. Subjects were asked if they are a previous or current smoker via a survey during study visit.|Single Visit|||participants|||Number
675799|NCT01634620|Primary|FeNO Levels by Inhaled Corticosteroid Use|Forced exhaled nitric oxide (FeNO) was measured using a NIOX MINO device. Reported values are the number of participants with low FeNO (<25 parts per billion or ppb), moderate FeNO (>=25 ppb or <=50 ppb), or high FeNO >50 ppb. Use of Inhaled corticosteroids was measured via a survey during study visit.|Single Visit|Per-protocol Population||participants|||Number
675800|NCT01634620|Primary|FeNO Levels by GOLD Stage of Severity|Forced exhaled nitric oxide (FeNO) was measured using a NIOX MINO device. The purpose of this study was to characterize FeNO levels indicative of eosinophilic airway inflammation in patients with chronic obstructive pulmonary disease (COPD). The principal investigator classified subjects into one of four stages of severity using the Global Initiative for Chronic Obstructive Lung Disease (GOLD) severity of COPD stages, with Stage I representing mild COPD severity, Stage II representing moderate COPD severity, Stage III representing severe COPD severity, and Stage IV representing very severe COPD severity (GOLD guidelines, 2012). FeNO levels (in parts per billion or ppb) are summarized for subjects within each category.|Single Visit|Per-protocol Population||parts per billion (ppb)||Standard Deviation|Mean
675801|NCT01634620|Primary|Spirometry Results: PEF (L/Min)|Spirometry values were collected according to American Thoracic Society (ATS) guidelines (ATS, 2005). In the event that spirometry preceded forced exhaled nitric oxide (FeNO) measurements, a wait of not less than 20 minutes was imposed to separate the two procedures. Parameters measured were Forced Expiratory Volume in One Second (FEV1), Forced Vital Capacity (FVC), Forced Expiratory Flow 25-75 (FEF15%-75%), Forced Expiratory Flow 50 (FEF50), and Peak Expiratory Flow (PEF). Spirometry measures the severity of a patient's chronic obstructive pulmonary disease (COPD), with lower scores indicating more severe COPD.|Single Visit|Per-protocol Population||Liters per minute||Standard Deviation|Mean
675802|NCT01634620|Primary|Spirometry Results: FEF25-75 (L/Sec)|Spirometry values were collected according to American Thoracic Society (ATS) guidelines (ATS, 2005). In the event that spirometry preceded forced exhaled nitric oxide (FeNO) measurements, a wait of not less than 20 minutes was imposed to separate the two procedures. Parameters measured were Forced Expiratory Volume in One Second (FEV1), Forced Vital Capacity (FVC), Forced Expiratory Flow 25-75 (FEF15%-75%), Forced Expiratory Flow 50 (FEF50), and Peak Expiratory Flow (PEF). Spirometry measures the severity of a patient's chronic obstructive pulmonary disease (COPD), with lower scores indicating more severe COPD.|Single Visit|Per-protocol Population||Liters per second||Standard Deviation|Mean
675803|NCT01634620|Primary|Spirometry Results: FEF50% (L/Sec)|Spirometry values were collected according to American Thoracic Society (ATS) guidelines (ATS, 2005). In the event that spirometry preceded forced exhaled nitric oxide (FeNO) measurements, a wait of not less than 20 minutes was imposed to separate the two procedures. Parameters measured were Forced Expiratory Volume in One Second (FEV1), Forced Vital Capacity (FVC), Forced Expiratory Flow 25-75 (FEF15%-75%), Forced Expiratory Flow 50 (FEF50), and Peak Expiratory Flow (PEF). Spirometry measures the severity of a patient's chronic obstructive pulmonary disease (COPD), with lower scores indicating more severe COPD.|Single Visit|Per-protocol Population||Liters per second||Standard Deviation|Mean
675804|NCT01634620|Primary|Spirometry Results: FEV1 (% Predicted)|Spirometry values were collected according to American Thoracic Society (ATS) guidelines (ATS, 2005). In the event that spirometry preceded forced exhaled nitric oxide (FeNO) measurements, a wait of not less than 20 minutes was imposed to separate the two procedures. Parameters measured were Forced Expiratory Volume in One Second (FEV1), Forced Vital Capacity (FVC), Forced Expiratory Flow 25-75 (FEF15%-75%), Forced Expiratory Flow 50 (FEF50), and Peak Expiratory Flow (PEF). Spirometry measures the severity of a patient's chronic obstructive pulmonary disease (COPD), with lower scores indicating more severe COPD.|Single Visit|Per-protocol Population||Percent Predicted||Standard Deviation|Mean
675805|NCT01634620|Primary|Spirometry Results: FVC (L)|Spirometry values were collected according to American Thoracic Society (ATS) guidelines (ATS, 2005). In the event that spirometry preceded forced exhaled nitric oxide (FeNO) measurements, a wait of not less than 20 minutes was imposed to separate the two procedures. Parameters measured were Forced Expiratory Volume in One Second (FEV1), Forced Vital Capacity (FVC), Forced Expiratory Flow 25-75 (FEF15%-75%), Forced Expiratory Flow 50 (FEF50), and Peak Expiratory Flow (PEF). Spirometry measures the severity of a patient's chronic obstructive pulmonary disease (COPD), with lower scores indicating more severe COPD.|Single Visit|Per-protocol Population||Liters||Standard Deviation|Mean
675806|NCT01634620|Primary|Spirometry Results: FEV1 (L)|Spirometry values were collected according to American Thoracic Society (ATS) guidelines (ATS, 2005). In the event that spirometry preceded forced exhaled nitric oxide (FeNO) measurements, a wait of not less than 20 minutes was imposed to separate the two procedures. Parameters measured were Forced Expiratory Volume in One Second (FEV1), Forced Vital Capacity (FVC), Forced Expiratory Flow 25-75 (FEF15%-75%), Forced Expiratory Flow 50 (FEF50), and Peak Expiratory Flow (PEF). Spirometry measures the severity of a patient's chronic obstructive pulmonary disease (COPD), with lower scores indicating more severe COPD.|Single Visit|Per-protocol Population||Liters||Standard Deviation|Mean
675807|NCT01634555|Primary|Pharmacokinetics: Dose-Normalized Cmax of Irinotecan and Its Metabolite SN-38 in Cycle 2|Dose-normalized Cmax was calculated from Cmax divided by the dose. Data presented are Geo LS means. Geo LS means were adjusted for cycle, participant and random error.|Cycle 2: 0, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 22, 25, 28, 31, 34, 48, 72, 96 and 168 hours post-irinotecan infusion|All participants in DDI population (who completed the required treatment in Cycle 1, Day 1 and Cycle 2, Day 1) and had sufficient concentration data to calculate irinotecan and its metabolite SN-38 Cmax in Cycle 2.||nanograms/milliliter/milligram||90% Confidence Interval|Least Squares Mean
675808|NCT01634555|Primary|Pharmacokinetics: Dose-Normalized Maximum Observed Drug Concentration (Cmax) of Irinotecan and Its Metabolite SN-38 in Cycle 1|Dose-normalized Cmax was calculated from Cmax divided by the dose. Data presented are Geo LS means. Geo LS means were adjusted for cycle, participant and random error.|Cycle 1: 0, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 22, 25, 28, 31, 34, 48, 72, 96 and 168 hours post-irinotecan infusion|All participants in DDI population (who completed the required treatment in Cycle 1, Day 1 and Cycle 2, Day 1) and had sufficient concentration data to calculate irinotecan and its metabolite SN-38 Cmax in Cycle 1.||nanograms/milliliter/milligram||90% Confidence Interval|Least Squares Mean
675809|NCT01634555|Primary|Pharmacokinetics: Dose-Normalized AUC(0-∞) of Irinotecan and Its Metabolite SN-38 in Cycle 2|Dose-normalized AUC(0-∞) was calculated from AUC(0-∞) divided by the dose. Data presented are Geo LS means. Geo LS means were adjusted for cycle, participant and random error.|Cycle 2: 0, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 22, 25, 28, 31, 34, 48, 72, 96 and 168 hours post-irinotecan infusion|All participants in DDI population (who completed the required treatment in Cycle 1, Day 1 and Cycle 2, Day 1) and had sufficient concentration data to calculate irinotecan and its metabolite SN-38 AUC(0-∞) in Cycle 2.||nanograms*hour/milliliter/milligram||90% Confidence Interval|Least Squares Mean
675810|NCT01634555|Secondary|Development of Antibodies Against Ramucirumab||Prior to ramucirumab infusion in Cycle 2, Day 1, End of treatment, and 30-day follow-up||06/2017||||
675811|NCT01634555|Secondary|Pharmacokinetics: Cmax of Ramucirumab (IMC-1121B)||Cycle 2: -2, -1, -0.5, 0, 2, 3, 4, 5, 8, 10, 25, 48, 72, 96, 168, 264, 336 hours post-ramucirumab (IMC-1121B) infusion|All participants who received study drug and had sufficient concentration data to calculate ramucirumab (IMC-1121B) Cmax in Cycle 2.||micrograms/milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
675812|NCT01634555|Primary|Pharmacokinetics: Dose-Normalized Area Under the Concentration Versus Time Curve of Irinotecan and Its Metabolite SN-38 From Time Zero to Infinity [AUC(0-∞)] in Cycle 1|Dose-normalized AUC(0-∞) was calculated from AUC(0-∞) divided by the dose. Data presented are Geometric Least Squares (Geo LS) means. Geo LS means were adjusted for cycle, participant and random error.|Cycle 1: 0, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 22, 25, 28, 31, 34, 48, 72, 96 and 168 hours post-irinotecan infusion|All participants in DDI population (who completed the required treatment in Cycle 1, Day 1 and Cycle 2, Day 1) and had sufficient concentration data to calculate irinotecan and its metabolite SN-38 AUC(0-∞) in Cycle 1.||nanograms*hour/milliliter/milligram||90% Confidence Interval|Least Squares Mean
675813|NCT01634360|Secondary|Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) During Open- Label Extension Study|"Unified Parkinson's Disease Rating Scale (UPDRS) is a standardized assessment of the symptoms and signs of Parkinson's Disease. Part III assesses motor activity, based on 14 items, such as gait, facial expression, and rigidity. Participants receive a score of 0-4 points per item, with a higher score indicating more severe symptoms. Range of possible total scores, 0 to 56.
ON state is when medication is providing benefits with regard to stiffness, slowness, and tremor."|Baseline, Week 0, Week 12, Week 24, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156|Efficacy Population||Scores on scale||Standard Deviation|Mean
675814|NCT01634360|Secondary|Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) During Open-label Extension Study|ON state is when medication is providing benefits with regard to stiffness, slowness, and tremor. This outcome measure was based on data collected through use of a patient diary.|Baseline, Week 0, Week 12, Week 24, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156|Efficacy Population||Hours||Standard Deviation|Mean
675815|NCT01634360|Primary|Mean Change From Baseline in Total Daily OFF Time (Hours) During Open-label Extension Study|OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor. This outcome measure was based on data collected through use of a patient diary.|Baseline, Week 0, Week 12, Week 24, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156|Efficacy Population- All subjects who were in the Safety Population and for whom at least 1 postbaseline (post Week 0) efficacy assessment was made.||Hours||Standard Deviation|Mean
675816|NCT01634256|Secondary|Changes in Serum Bilirubin|serum bilirubin was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis||mg/dL||Standard Deviation|Mean
675817|NCT01634256|Secondary|Changes in γ-GT(Gamma-Glutamyl Transferase)|γ-GT was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis||IU/L||Standard Deviation|Mean
675818|NCT01634256|Secondary|Changes in ALP(Alkaline Phosphatase)|ALP was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis||IU/L||Standard Deviation|Mean
675822|NCT01634243|Secondary|Total of UPDRS Part 2 Sum Score (Average Score of on State and Off State) and Part 3 Sum Score for Advanced Parkinson's Disease With Concomitant L-dopa Therapy|"Mean change (LOCF) from baseline in Total of UPDRS Part 2 sum score (average score of on state and off state) and Part 3 sum score at 12 weeks after dosing.
UPDRS sub-scale Part 2 assesses 13 items and Part 3 assesses 14 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, 12 weeks after dosing|Efficacy analysis set, LOCF||Scores on a scale||Standard Deviation|Mean
675823|NCT01634243|Secondary|UPDRS Part 2 Sum Score (Average Score of on State and Off State) for Advanced Parkinson's Disease With Concomitant L-dopa Therapy|"Mean change (LOCF) from baseline in UPDRS Part 2 sum score (average score of on state and off state) at 12 weeks after dosing.
UPDRS sub-scale Part 2 assesses 13 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, 12 weeks after dosing|Efficacy analysis set, LOCF||Scores on a scale||Standard Deviation|Mean
675824|NCT01634243|Secondary|UPDRS Part 2 Sum Score (Off State) for Advanced Parkinson's Disease With Concomitant L-dopa Therapy.|"Mean change (LOCF) from baseline in UPDRS Part 2 sum score (off state) at 12 weeks after dosing.
UPDRS sub-scale Part 2 assesses 13 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, 12 weeks after dosing|Efficacy analysis set, LOCF||Scores on a scale||Standard Deviation|Mean
675825|NCT01634243|Secondary|UPDRS Part 2 Sum Score (on State) for Advanced Parkinson's Disease With Concomitant L-dopa Therapy.|"Mean change (LOCF) from baseline in UPDRS Part 2 sum score (on state) at 12 weeks after dosing.
UPDRS sub-scale Part 2 assesses 13 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, 12 weeks after dosing|Efficacy analysis set, LOCF||Scores on a scale||Standard Deviation|Mean
675826|NCT01634243|Secondary|UPDRS Part 3 Sum Score for Early Parkinson's Disease Without Concomitant L-dopa Therapy|"Mean change (LOCF) from baseline in UPDRS Part 3 sum score at 12 weeks after dosing.
UPDRS sub-scale Part 3 assesses 14 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, 12 weeks after dosing|Efficacy analysis set, LOCF||Scores on a scale||Standard Deviation|Mean
675827|NCT01634243|Secondary|UPDRS Part 2 Sum Score for Early Parkinson's Disease Without Concomitant L-dopa Therapy|"Mean change (LOCF) from baseline in UPDRS Part 2 sum score at 12 weeks after dosing.
UPDRS sub-scale Part 2 assesses 13 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, 12 weeks after dosing|Efficacy analysis set, LOCF||Scores on a scale||Standard Deviation|Mean
675828|NCT01634243|Secondary|UPDRS Part 3 Sum Score for Advanced Parkinson's Disease With Concomitant L-dopa Therapy|"Mean change (LOCF) from baseline in UPDRS Part 3 sum score at 12 weeks after dosing.
UPDRS sub-scale Part 3 assesses 14 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|baseline, 12 weeks after dosing|Efficacy analysis set, LOCF||Scores on a scale||Standard Deviation|Mean
675829|NCT01634243|Secondary|Total of Unified Parkinson's Disease Rating Scale (UPDRS) Part 2 Sum Score and Part 3 Sum Score for Early Parkinson's Disease Without Concomitant L-dopa Therapy|"Mean change (LOCF) from baseline in Total of UPDRS Part 2 sum score and Part 3 sum at 12 weeks after dosing.
UPDRS is a scale for monitoring Parkinson's Disease-related disability and impairment. The UPDRS consists of the following four sub-scales. Part 1: Mentation, Part 2: Activities of Daily Living, Part 3: Motor, Part 4: Complications. Part 2 assesses 13 items and Part 3 assesses 14 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|baseline, 12 weeks after dosing|Efficacy analysis set, last observation carried forward (LOCF)||Scores on a scale||Standard Deviation|Mean
675830|NCT01634243|Secondary|Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters|Incidence and severity of adverse events, vital signs, and laboratory parameters following the initiation of study treatment.|Up to 12 weeks after dosing|Safety analysis set||participants|||Number
675831|NCT01634243|Primary|Maintenance Dose of the SPM962|The maintenance dose of the SPM 962 was examined based on the safety and efficacy.|Up to 12 weeks after dosing|Subjects in the safety analysis set who entered the maintenance period||participants|||Number
675832|NCT01634165|Secondary|Total Amount of Glucose Infused (Gtot)|Gtot is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of LY2963016 or Lantus by adjusting the exogenous glucose infusion rate.|Postdose up to 24 hours after administration of study drug|All participants who received study drug and had Gtot measurements. Participants were analyzed based on the treatment they received.||milligrams per kilograms (mg/kg)||Geometric Coefficient of Variation|Geometric Mean
675833|NCT01634165|Secondary|Maximum Glucose Infusion Rate (Rmax)|Rmax is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of LY2963016 or Lantus by adjusting the exogenous glucose infusion rate.|Postdose up to 24 hours after administration of study drug|All participants who received study drug and had Rmax measurements. Participants were analyzed based on the treatment they received.||milligrams/kilograms/minute (mg/kg/min)||Geometric Coefficient of Variation|Geometric Mean
675834|NCT01634165|Secondary|Pharmacokinetics: Area Under the Serum Concentration-Time Curve (AUC) From Time Zero to Last Measured Concentration Value [AUC(0-tlast)] of LY2963016 or Lantus|Results for LY2936016 treatment arms provide the AUC(0-tlast) data for LY2936016, while the results for Lantus treatment arms provide the AUC(0-tlast) for Lantus.|Predose up to 24 hours after administration of study drug|All participants who received study drug and had sufficient pharmacokinetic data to calculate AUC(0-tlast). Participants were analyzed based on the treatment they received.||picomoles*hour per liter (pmol*h/L)||Geometric Coefficient of Variation|Geometric Mean
675835|NCT01634165|Secondary|Pharmacokinetics: Area Under the Serum Concentration-Time Curve From Time Zero to 24 Hours [AUC(0-24)] of LY2963016 or Lantus|Results for LY2936016 treatment arms provide the AUC(0-24) data for LY2936016, while the results for Lantus treatment arms provide the AUC(0-24) for Lantus.|Predose up to 24 hours after administration of study drug|All participants who received study drug and had sufficient pharmacokinetic data to calculate AUC(0-24). Participants were analyzed based on the treatment they received.||picomoles*hour per liter (pmol*h/L)||Geometric Coefficient of Variation|Geometric Mean
675836|NCT01634165|Primary|Pharmacokinetics: Maximum Serum LY2963016 or Lantus Concentration (Cmax)||Predose up to 24 hours after administration of study drug|All participants who received study drug and had sufficient pharmacokinetic data to calculate Cmax. Participants were analyzed based on the treatment they received.||picomoles per liter (pmol/L)||Geometric Coefficient of Variation|Geometric Mean
675837|NCT01634165|Primary|Pharmacokinetics: Area Under the Serum LY2963016 or Lantus Concentration-Time Curve (AUC) From Zero to Infinity [AUC(0-∞)]|Results for LY2936016 treatment arms provide the AUC(0-∞) data for LY2936016, while the results for Lantus treatment arms provide the AUC(0-∞) for Lantus.|Predose up to 24 hours after administration of study drug|All participants who received study drug and had sufficient pharmacokinetic data to calculate AUC(0-∞). Participants were analyzed based on the treatment they received.||picomoles*hour per liter (pmol*h/L)||Geometric Coefficient of Variation|Geometric Mean
675838|NCT01634152|Secondary|Change From Baseline in Asthma Symptom-free Days|"Change from baseline in asthma symptom-free days based on the weekly mean at week 12.
A day was considered as an asthma symptom-free day if there were no symptoms reported via the e-Diary and no use of rescue medication reported via the eDiary during that day.
Measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Days||Standard Error|Mean
675839|NCT01634152|Secondary|Change From Baseline in Daytime Experiences of Wheeze or Cough|"Change from baseline in daytime experiences of wheeze or cough based on the weekly mean at week 12.
Daytime experiences of wheeze or cough was assessed by the question did you experience wheeze or cough during the day? from the e-diary. Scores range from 1 (not at all) to 5 (all the time).
Measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Units on a scale||Standard Error|Mean
675840|NCT01634152|Secondary|Change From Baseline in Daytime Experiences of Shortness of Breath|"Change from baseline in daytime experiences of shortness of breath based on the weekly mean at week 12.
Daytime experiences of shortness of breath was assessed by the question how much shortness of breath did you experience during the day from the e-diary. Scores range from 1 (none) to 5 (a very great deal).
Measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Units on a scale||Standard Error|Mean
675841|NCT01634152|Secondary|Change From Baseline in Daytime Activity Limitations|"Change from baseline in daytime activity limitations based on the weekly mean at week 12.
Daytime activity limitations was assessed by the question how limited were you in your activities today because of your asthma? from the e-diary. Scores range from 1 (not limited) to 5 (totally limited).
Measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Units on a scale||Standard Error|Mean
675842|NCT01634152|Secondary|Change From Baseline in Daytime Asthma Symptoms|"Change from baseline in daytime asthma symptoms based on the weekly mean at week 12.
Daytime asthma symptoms was assessed by the question how were your asthma symptoms during the day? from the e-diary. Scores range from 1 (no asthma symptoms) to 5 (very severe asthma symptoms).
Measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Units on a scale||Standard Error|Mean
675843|NCT01634152|Secondary|Change From Baseline in Morning Asthma Symptoms|"Change from baseline in morning asthma symptoms based on the weekly mean at week 12.
Morning asthma symptoms was assessed by the question how were your asthma symptoms this morning? from the e-diary. Scores range from 1 (no asthma symptoms) to 5 (very severe asthma symptoms).
Measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Units on a scale||Standard Error|Mean
675844|NCT01634152|Secondary|Change From Baseline in Nighttime Awakenings|"Change from baseline in nighttime awakenings based on the weekly mean at week 12.
Nighttime awakenings was assessed by the question Did you wake up during the night due to your asthma? from the e-diary. Scores range from 1 (did not wake up) to 5 (was awake all night).
Measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Units on a scale||Standard Error|Mean
675845|NCT01634152|Secondary|FEV1 p.m. Change From Baseline|"Change from baseline in evening (p.m.) FEV1 based on the weekly mean at week 12.
Measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Litres||Standard Error|Mean
675846|NCT01634152|Secondary|FEV1 a.m. Change From Baseline|"Change from baseline in morning (a.m.) FEV1 based on the weekly mean at week 12.
Measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Litres||Standard Error|Mean
675847|NCT01634152|Secondary|Peak Expiratory Flow (PEF) Variability Change From Baseline|"Change from baseline in the peak expiratory flow variability based on the weekly mean at week 12.
Measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Percentage of PEF||Standard Error|Mean
686658|NCT01487577|Secondary|Pharmacokinetic Analysis of MMF Clearance to Evaluate MMF Dose Relationships to Drug Exposure.|Pharmacokinetic analysis includes, but is not limited to, clearance.|100 days|||mL/min/kg||Full Range|Median
675849|NCT01634152|Secondary|Peak Expiratory Flow (PEF) a.m. Change From Baseline|"Change from baseline in the morning (a.m.) peak expiratory flow based on the weekly mean at week 12.
Measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||L/min||Standard Error|Mean
675850|NCT01634152|Secondary|Use of PRN Rescue Medication During the Night-time|"Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used during the night-time based on the weekly mean at week 12.
Measured values presented are actually adjusted means"|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Number of puffs of rescue medication||Standard Error|Mean
675851|NCT01634152|Secondary|Use of PRN Rescue Medication During the Daytime|"Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used during the daytime based on the weekly mean at week 12.
Measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Number of puffs of rescue medication||Standard Error|Mean
675852|NCT01634152|Secondary|Use of PRN Rescue Medication Per Day|"Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used per day (24 hour period) based on the weekly mean at week 12.
The measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Number of puffs of rescue medication||Standard Error|Mean
675853|NCT01634152|Secondary|ACQ-IA Total Score Responders|"Responder categories based on the ACQ-IA total score after 12 weeks of treatment. Analysis was performed using the following categories and definitions: responder (change from trial baseline ≤-0.5), no change (-0.5 <change from trial baseline <0.5) and worsening (change from trial baseline ≥0.5) No statistical testing was performed for ACQ-IA total score responders.
The ACQ-IA is a scale containing 7 questions, each question has a 7-point scale which ranges from 0 to 6; a score of 0 corresponds to no impairment and a score of 6 corresponds to maximum impairment."|12 weeks|FAS, missing data for patients not withdrawn from the study were either categorised as no change or based on available data, withdrawn patients were imputed based upon discontinuation reason.||Percentage of participants|||Number
675854|NCT01634152|Secondary|Control of Asthma as Assessed by ACQ-IA Total Score|"Change from baseline in Interviewer-Administered Asthma Control Questionnaire (ACQ-IA) total score measured at week 12.
The ACQ-IA is a scale containing 7 questions. Each question has a 7 point scale which ranges from 0 to 6. A score of 0 corresponds to no impairment and a score of 6 corresponds to maximum impairment. ACQ-IA total score is calculated as the mean of the responses to all 7 questions.
The measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Units on a scale||Standard Error|Mean
675855|NCT01634152|Secondary|FVC Change From Baseline at Each Individual Timepoint|"FVC change from baseline at each individual timepoint.
The measured values presented are actually adjusted means."|Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Litres||Standard Error|Mean
675856|NCT01634152|Secondary|FEV1 Change From Baseline at Each Individual Timepoint|"Forced expiratory volume in one second (FEV1) change from baseline at each individual timepoint.
The measured values presented are actually adjusted means."|Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Litres||Standard Error|Mean
675857|NCT01634152|Secondary|FVC AUC (0-3h) Change From Baseline|"Change from baseline of area under the curve (AUC) from 0 to 3 hours for FVC (Forced vital capacity) (FVC AUC (0-3h)) after 12 weeks of treatment. The AUC was calculated by using the trapezoidal rule divided by the observation time (3h).
Measured values presented are actually adjusted means."|Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Litres||Standard Error|Mean
675858|NCT01634152|Secondary|FEV1 AUC (0-3h) Change From Baseline|"Change from baseline of area under the curve (AUC) from 0 to 3 hours for FEV1 (FEV1 AUC (0-3h)) after 12 weeks of treatment. The AUC was calculated by using the trapezoidal rule divided by the observation time (3h).
Measured values presented are actually adjusted means."|Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Litres||Standard Error|Mean
675859|NCT01634152|Secondary|Trough FVC Change From Baseline|"Change from baseline in Trough (pre-dose) FVC measured at week 12.
Measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Litres||Standard Error|Mean
675860|NCT01634152|Secondary|FVC Peak(0-3h) Change From Baseline|"Change from baseline in Maximum forced vital capacity (FVC) measured within the first 3 hours after administration of trial medication (FVC peak(0-3h)) after 12 weeks of treatment.
The measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Litres||Standard Error|Mean
675861|NCT01634152|Secondary|Trough FEV1 Change From Baseline|"Change from baseline in Trough (pre-dose) Forced expiratory volume in 1 second (FEV1) measured at week 12.
Measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Litres||Standard Error|Mean
676311|NCT01627002|Primary|Immunogenicity|Anti-drug antibody data|Up to 28 days post dose|Safety analyses were performed on all subjects who received a dose of PA401 or placebo and who had any post-dose assessments||participants|||Number
675862|NCT01634152|Primary|FEV1 Peak(0-3h) Change From Baseline|"Change from baseline in peak forced expiratory volume in 1 second within the first 3 hours post dosing (FEV1 peak(0-3h)) measured at week 12.
Measured values presented are actually adjusted means."|Baseline and 12 weeks|Full Analysis Set (FAS) was the same as the treated set which included all randomised patients who were dispensed and received at least one documented dose of trial medication. Missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Litres||Standard Error|Mean
675863|NCT01634139|Secondary|Change From Baseline in Asthma Symptom-free Days|"Change from baseline in asthma symptom-free days based on the weekly mean at weeks 24 and 48.
A day was considered as an asthma symptom-free day if there were no symptoms reported via the e-Diary (electronic diary) and no use of rescue medication reported via the eDiary during that day.
Measured values presented are actually adjusted means.
The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Days||Standard Error|Mean
675864|NCT01634139|Secondary|Change From Baseline in Daytime Experiences of Wheeze or Cough|"Change from baseline in daytime experiences of wheeze or cough based on the weekly mean at weeks 24 and 48.
Daytime experiences of wheeze or cough was assessed by the question did you experience wheeze or cough during the day? from the e-diary. Scores range from 1 (not at all) to 5 (all the time).
Measured values presented are actually adjusted means.
The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Units on a scale||Standard Error|Mean
675865|NCT01634139|Secondary|Change From Baseline in Daytime Experiences of Shortness of Breath|"Change from baseline in daytime experiences of shortness of breath based on the weekly mean at weeks 24 and 48.
Daytime experiences of shortness of breath was assessed by the question how much shortness of breath did you experience during the day from the e-diary. Scores range from 1 (none) to 5 (a very great deal).
Measured values presented are actually adjusted means.
The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Units on a scale||Standard Error|Mean
675866|NCT01634139|Secondary|Change From Baseline in Daytime Activity Limitations|"Change from baseline in daytime activity limitations based on the weekly mean at weeks 24 and 48.
Daytime activity limitations was assessed by the question how limited were you in your activities today because of your asthma? from the e-diary. Scores range from 1 (not limited) to 5 (totally limited).
Measured values presented are actually adjusted means.
The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Units on a scale||Standard Error|Mean
675867|NCT01634139|Secondary|Change From Baseline in Daytime Asthma Symptoms|"Change from baseline in daytime asthma symptoms based on the weekly mean at weeks 24 and 48.
Daytime asthma symptoms was assessed by the question how were your asthma symptoms during the day? from the e-diary. Scores range from 1 (no asthma symptoms) to 5 (very severe asthma symptoms).
Measured values presented are actually adjusted means.
The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Units on a scale||Standard Error|Mean
675868|NCT01634139|Secondary|Change From Baseline in Morning Asthma Symptoms|"Change from baseline in morning asthma symptoms based on the weekly mean at weeks 24 and 48.
Morning asthma symptoms was assessed by the question how were your asthma symptoms this morning? from the e-diary. Scores range from 1 (no asthma symptoms) to 5 (very severe asthma symptoms).
Measured values presented are actually adjusted means.
The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Units on a scale||Standard Error|Mean
675869|NCT01634139|Secondary|Change From Baseline in Nighttime Awakenings|"Change from baseline in nighttime awakenings based on the weekly mean at weeks 24 and 48.
Nighttime awakenings was assessed by the question Did you wake up during the night due to your asthma? from the e-diary. Scores range from 1 (did not wake up) to 5 (was awake all night).
Measured values presented are actually adjusted means.
The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Units on a scale||Standard Error|Mean
675870|NCT01634139|Secondary|Responders in PAQLQ(S) at Weeks 24 and 48|"Responders in PAQLQ(S) at weeks 24 and 48. Analysis was performed using the following categories and definitions: responder (change from trial baseline ≥0.5), no change (-0.5 <change from trial baseline <0.5) and worsening (change from trial baseline ≤-0.5). No statistical testing was performed for PAQLQ(S) total score responders.
The PAQLQ(S) is 23 questions on a 7-point scale, ranging from 1 (worst control) to 7 (best control)."|Weeks 24 and 48.|FAS, missing data for patients not withdrawn from the study were either categorised as no change or based on available data, withdrawn patients were imputed based upon discontinuation reason.||Patients|||Number
675871|NCT01634139|Secondary|PAQLQ(S) Emotional Function Domain Score|"PAQLQ(S) emotional function domain score at weeks 24 and 48. The PAQLQ(S) is 23 questions on a 7-point scale, ranging from 1 (worst control) to 7 (best control). The individual domain score is calculated as the mean of the items in this domain.
The measured values presented are actually adjusted means.
The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Weeks 24 and 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Units on a Scale||Standard Error|Mean
675872|NCT01634139|Secondary|PAQLQ(S) Activity Limitation Domain Score|"PAQLQ(S) activity limitation domain score at weeks 24 and 48. The PAQLQ(S) is 23 questions on a 7-point scale, ranging from 1 (worst control) to 7 (best control). The individual domain score is calculated as the mean of the items in this domain.
The measured values presented are actually adjusted means.
The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Weeks 24 and 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Units on a Scale||Standard Error|Mean
675873|NCT01634139|Secondary|PAQLQ(S) Symptom Domain Score|"PAQLQ(S) symptom domain score at weeks 24 and 48. The PAQLQ(S) is 23 questions on a 7-point scale, ranging from 1 (worst control) to 7 (best control). The individual domain score was calculated as the mean of the items in the domain.
The measured values presented are actually adjusted means.
The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Weeks 24 and 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Units on a Scale||Standard Error|Mean
675874|NCT01634139|Secondary|PAQLQ(S) Total Score|"Standardised Paediatric Asthma Quality of Life Questionnaire (PAQLQ(S)) total score at weeks 24 and 48.
The PAQLQ(S) is 23 questions on a 7-point scale, ranging from 1 (worst control) to 7 (best control). Total Score is calculated as mean of all 23 questions.
The measured values presented are actually adjusted means.
The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Weeks 24 and 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Units on a Scale||Standard Error|Mean
675875|NCT01634139|Secondary|ACQ−IA Responder Analysis|"Responder categories based on the ACQ-IA total score after 24 and 48 weeks of treatment. Analysis was performed using the following categories and definitions: responder (change from trial baseline ≤-0.5), no change (-0.5 <change from trial baseline <0.5) and worsening (change from trial baseline ≥0.5). No statistical testing was performed for ACQ-IA total score responders.
The ACQ-IA is a scale containing 7 questions, each question has a 7-point scale which ranges from 0 to 6; a score of 0 corresponds to no impairment and a score of 6 corresponds to maximum impairment."|Weeks 24 and 48|FAS, missing data for patients not withdrawn from the study were either categorised as no change or based on available data, withdrawn patients were imputed based upon discontinuation reason||Patients|||Number
675876|NCT01634139|Secondary|ACQ−IA Total Score|"Interviewer Administered Asthma Control Questionnaire (ACQ-IA) total score after 24 and 48 weeks of treatment.
The ACQ-IA is a scale containing 7 questions. Each question has a 7 point scale which ranges from 0 to 6. A score of 0 corresponds to no impairment and a score of 6 corresponds to maximum impairment. ACQ-IA total score is calculated as the mean of the responses to all 7 questions.
The measured values presented are actually adjusted means.
The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Weeks 24 and 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Units on a Scale||Standard Error|Mean
675877|NCT01634139|Secondary|FEV1 p.m. Change From Baseline|"Change from baseline in evening (p.m.) FEV1 based on the weekly mean at week 24 and 48.
Measured values presented are actually adjusted means.
The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Litres (L)||Standard Error|Mean
675878|NCT01634139|Secondary|FEV1 a.m Change From Baseline|"Change from baseline in morning (a.m.) FEV1 based on the weekly mean at week 24 and 48.
The measured values presented are actually adjusted means.
The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Litres||Standard Error|Mean
675879|NCT01634139|Secondary|PEF Variability Change From Baseline|"Change from baseline in the peak expiratory flow variability based on the weekly mean at week 24 and 48.
Measured values presented are actually adjusted means.
The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Percentage of PEF||Standard Error|Mean
675880|NCT01634139|Secondary|PEF p.m. Change From Baseline|"Change from baseline in the evening (p.m.) peak expiratory flow based on the weekly mean at weeks 24 and 48.
Measured values presented are actually adjusted means.
The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Litres per min (L/min)||Standard Error|Mean
675881|NCT01634139|Secondary|Peak Expiratory Flow (PEF) a.m. Change From Baseline|"Change from baseline in the morning (a.m.) peak expiratory flow based on the weekly mean at weeks 24 and 48.
Measured values presented are actually adjusted means.
The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Litres per min (L/min)||Standard Error|Mean
675882|NCT01634139|Secondary|Use of PRN Rescue Medication During Nighttime|"Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used during nighttime based on the weekly mean at weeks 24 and 48.
Measured values presented are actually adjusted means.
The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Number of puffs of rescue medication||Standard Error|Mean
675883|NCT01634139|Secondary|Use of PRN Rescue Medication During Daytime|"Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used during daytime based on the weekly mean at weeks 24 and 48.
Measured values presented are actually adjusted means
The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Number of puffs of rescue medication||Standard Error|Mean
675884|NCT01634139|Secondary|Use of PRN (Pro re Nata) Rescue Medication Per Day|"Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used per day (24 hour period) based on the weekly mean at weeks 24 and 48.
The measured values presented are actually adjusted means.
The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Number of puffs of rescue medication||Standard Error|Mean
675885|NCT01634139|Secondary|FVC Change From Baseline at Each Individual Timepoint|"FVC change from baseline to week 24 at each individual timepoint.
The measured values presented are actually adjusted means
The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at Week 24|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Litres (L)||Standard Error|Mean
675886|NCT01634139|Secondary|FVC AUC (0-3h) Change From Baseline|"Change from baseline of area under the curve (AUC) from 0 to 3 hours for FVC (Forced vital capacity) (FVC AUC (0-3h)) after 24 weeks of treatment. The AUC was calculated by using the trapezoidal rule divided by the observation time (3h).
Measured values presented are actually adjusted means.
The number of participants analysed displays the number of participants with available data at the timepoint of interest."|Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 24 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Litres (L)||Standard Error|Mean
675887|NCT01634139|Secondary|Trough FVC Change From Baseline|"Change from baseline in Trough (pre-dose) FVC measured at week 24 and 48.
Measured values presented are actually adjusted means.
The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Litres (L)||Standard Error|Mean
675888|NCT01634139|Secondary|FVC Peak(0-3h) Change From Baseline|"Change from baseline in Maximum forced vital capacity (FVC) measured within the first 3 hours after administration of trial medication (FVC peak(0-3h)) after 24 and 48 Weeks of treatment.
Measured values presented are actually adjusted means.
The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Litres (L)||Standard Error|Mean
675889|NCT01634139|Secondary|FEV1 Change From Baseline at Each Individual Timepoint|"FEV1 change from baseline to week 24 at each individual timepoint.
The measured values presented are actually adjusted means.
The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 24 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Litres (L)||Standard Error|Mean
675890|NCT01634139|Secondary|FEV1 AUC (0-3h) Change From Baseline|"Change from baseline of area under the curve (AUC) from 0 to 3 hours for FEV1 (FEV1 AUC (0-3h)) after 24 weeks of treatment. The AUC was calculated by using the trapezoidal rule divided by the observation time (3h).
Measured values presented are actually adjusted means.
The number of participants analysed displays the number of participants with available data at the timepoint of interest."|Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at week 24|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Litres (L)||Standard Error|Mean
676312|NCT01627002|Primary|Treatment Emergent Adverse Events||up to 14 days post dose|Safety analyses were performed on all subjects who receive a dose of PA401 or placebo and who had any post-dose measurements||Participants|||Number
675891|NCT01634139|Secondary|FEV1 Peak (0-3h) at Week 48 Change From Baseline|"Change from baseline in peak forced expiratory volume (FEV) in 1 second within the first 3 hours (h) post dosing (FEV1 peak(0-3h)) measured at week 48.
Measured values presented are actually adjusted means.
The number of participants analysed displays the number of participants with available data at the timepoint of interest."|Baseline and Week 48.|FAS. Missing data at a visit was imputed by available data from the patient at that visit. Completely missing data were handled by the statistical model.||Litres (L)||Standard Error|Mean
675892|NCT01634139|Secondary|Trough FEV1 Change From Baseline|"Change from Baseline in Trough (pre-dose) Forced Expiratory Volume (FEV) in 1 second (FEV1) measured at week 24 and 48.
Measured values presented are actually adjusted means.
The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48.|Full Analysis Set (FAS) was equal to treated set which included all randomised patients who received at least 1 documented dose of study medication. Missing data at a visit was imputed by available data from the patient at that visit. Completely missing data were handled by the statistical model.||Litres (L)||Standard Error|Mean
675893|NCT01634139|Primary|FEV1 Peak (0-3h) Change From Baseline|"Change from baseline in peak forced expiratory volume (FEV) in 1 second within the first 3 hours (h) post dosing (FEV1 peak(0-3h)) measured at week 24.
Measured values presented are actually adjusted means.
The number of participants analysed displays the number of participants with available data at the timepoint of interest."|Baseline and 24 Weeks.|Full Analysis Set (FAS) was equal to treated set which included all randomised patients who received at least 1 documented dose of study medication. Missing data at a visit was imputed by available data from the patient at that visit. Completely missing data were handled by the statistical model.||Litres (L)||Standard Error|Mean
675894|NCT01634113|Secondary|Individual FVC Measurements|Change from baseline in individual FVC measurements at each timepoint after 12 weeks|Baseline and 12 weeks|Full analysis set including only 5 years olds capable of providing technically acceptable pulmonary function tests (PFTs). No imputation for missing data was employed.||Litres||Standard Deviation|Mean
675895|NCT01634113|Secondary|Individual FEV1 Measurements|Change from baseline in individual FEV1 measurements at each timepoint after 12 weeks|Baseline and 12 weeks|Full analysis set including only 5 years olds capable of providing technically acceptable pulmonary function tests (PFTs). No imputation for missing data was employed.||Litres||Standard Deviation|Mean
675896|NCT01634113|Secondary|FVC AUC (0-3h) Change From Baseline|Change from baseline of area under the curve (AUC) from 0 to 3 h for FVC (FVC AUC0–3h) after 12 weeks of treatment. The AUC was calculated by using the trapezoidal rule divided by the observation time (3h).|10 minutes before drug administration and 30 minutes, 1 hour (h), 2h and 3h after drug administration at baseline and week 12|Full analysis set including only 5 years olds capable of providing technically acceptable pulmonary function tests (PFTs). No imputation for missing data was employed.||Litres||Standard Deviation|Mean
675897|NCT01634113|Secondary|Trough FVC Change From Baseline|Change from baseline of trough (pre-dose) forced vital capacity (FVC) measured 10 min before the administration of trial medication after 12 weeks of treatment.|Baseline and 12 weeks|Full analysis set including only 5 years olds capable of providing technically acceptable pulmonary function tests (PFTs). No imputation for missing data was employed.||Litres||Standard Deviation|Mean
675898|NCT01634113|Secondary|FVC Peak (0-3h) Change From Baseline|Change from baseline in maximum forced vital capacity (FVC) measured within the first 3 hours after administration of trial medication (FVC peak (0–3h)) after 12 weeks of treatment.|10 minutes before drug administration and 30 minutes, 1 hour (h), 2h and 3h after drug administration at baseline and week 12|Full analysis set including only 5 years olds capable of providing technically acceptable pulmonary function tests (PFTs). No imputation for missing data was employed.||Litres||Standard Deviation|Mean
675899|NCT01634113|Secondary|FEV1 AUC (0-3h) Change From Baseline|Change from baseline of area under the curve (AUC) from 0 to 3 h for FEV1 (FEV1 AUC 0–3h) after 12 weeks of treatment. The AUC was calculated by using the trapezoidal rule divided by the observation time (3h).|10 minutes before drug administration and 30 minutes, 1 hour (h), 2h and 3h after drug administration at baseline and week 12|Full analysis set including only 5 years olds capable of providing technically acceptable pulmonary function tests (PFTs). No imputation for missing data was employed.||Litres||Standard Deviation|Mean
675900|NCT01634113|Secondary|Trough FEV1 Change From Baseline|Change from baseline in Trough (pre-dose) Forced expiratory volume in 1 second (FEV1) measured at week 12.|Baseline and 12 weeks|Full analysis set including only 5 years olds capable of providing technically acceptable pulmonary function tests (PFTs). No imputation for missing data was employed.||Litres||Standard Deviation|Mean
675901|NCT01634113|Secondary|Weekly Mean Nighttime Awakenings Due to Asthma Symptoms|"Change from baseline in the weekly mean nighttime awakenings due to asthma symptoms as assessed by the PACD, in the last week of the 12 week treatment period.
The weekly mean was calculated as the average of the weekly scores for the question “Did your child wake up during the night due to his/her asthma?” The question was answered on a 5-point verbal rating scale, with scores ranging from 1 (did not wake up) to 5 (was awake all night). A week was defined as 7 days.
The measured values presented are adjusted means"|Baseline and 12 weeks|Full analysis set, including patients with available endpoint data at week 12. Missing data in a week was imputed by the available data from the patient during that week, for weeks where data was completely missing no imputation was employed.||units on a scale||Standard Error|Mean
675902|NCT01634113|Secondary|Weekly Percentage of Days With Use of Salbutamol (Albuterol) Rescue Medication|Weekly percentage of days with use of salbutamol (albuterol) rescue medication at week 12. A week was defined as 7 days.|12 weeks|Full analysis set, including patients with available endpoint data at week 12. Missing data in a week was imputed by the available data from the patient during that week, for weeks where data was completely missing no imputation was employed.||percentage of days||Standard Deviation|Mean
675928|NCT01633827|Secondary|Apnea-Hypopnea Index|The Apnea-Hypopnea Index (AHI) is an index of sleep apnea severity that encompasses the frequency of apneas (cessations in breathing) and hypopneas (reductions in airflow).|Subjects will be assessed on day 1 (visit 1) and up to 1 month (visit 2)|During the placebo arm, one participant did not have OSA and another exhibited predominantly central sleep apnea; both were excluded from the analysis. Subject results for the 20 remaining patients are reported here per intervention.||events/hr||Standard Error|Mean
675903|NCT01634113|Secondary|Weekly Percentage of Days Without Asthma Symptoms|"Weekly Percentage of days without asthma symptoms at week 12.
A day without asthma symptoms was defined as a day during which the patient experienced no asthma symptoms, did not use rescue medication (salbutamol/albuterol) and had no asthma exacerbation/worsening requiring systemic corticosteroids, or unscheduled visits to a doctor’s office, emergency department, or hospital. A week was defined as 7 days.
The measured values presented are adjusted means"|12 weeks|Full analysis set, including patients with available endpoint data at week 12. Missing data in a week was imputed by the available data from the patient during that week, for weeks where data was completely missing no imputation was employed.||percentage of days||Standard Error|Mean
675904|NCT01634113|Secondary|Weekly Mean Overnight Asthma Symptom Score Response|"Change from baseline in the weekly mean overnight asthma symptom score response as assessed by the PACD in the last week of the 12 week treatment period.
The overnight score is the score from the following question in the PACD, How much did your child cough last night after your child was put to bed for the night until he/she awoke this morning?. This endpoint was determined only for patients with 2 or more nights with symptoms per week during the baseline period. In this case, the baseline period is the 7 days used to derive the baseline value. A patient has a night with symptoms if the question was answered with scores 1, 2, 3, 4 or 5 or the patient received β-Agonist at least one time since he/she went to bed. A week was defined as 7 days.
Scores range from 0 (best) to 4 (worst), a value of 5 indicates severity of symptoms is unknown.
The measured values presented are adjusted means"|Baseline and 12 weeks|Full analysis set, including patients with available endpoint data at week 12. Missing data in a week was imputed by the available data from the patient during that week, for weeks where data was completely missing no imputation was employed.||units on a scale||Standard Error|Mean
675905|NCT01634113|Primary|FEV1 Peak (0-3h) Change From Baseline|Change from baseline in peak Forced expiratory volume in 1 second within the first 3 hours post dosing (FEV1 peak (0-3h)) measured at week 12|10 minutes before drug administration and 30 minutes, 1 hour (h), 2h and 3h after drug administration at baseline and week 12|Full analysis set including only 5 years olds capable of providing technically acceptable pulmonary function tests (PFTs). No imputation for missing data was employed.||Litres||Standard Deviation|Mean
675906|NCT01634113|Primary|Weekly Mean Combined Daytime Asthma Symptom Score|"Change from baseline in the weekly mean combined daytime asthma symptom score as assessed by the Paediatric Asthma Caregivers Diary (PACD) in the last week of the 12 week treatment period.
The PACD is a diary designed to evaluate daily asthma symptoms in children aged 2-5 years. The diary consists of three questions to be answered each morning, when the child wakes up, and seven questions to be answered each evening, right after the child goes to bed for the night. A week was defined as 7 days.
The combined daytime score is the average of scores from questions 4 – 7 in the diary which are questions regarding severity of cough, wheezing, trouble breathing and interference with activities, scores for each question range from 0 (best) to 5 (worst). The week 12 weekly mean is the mean of the responses for each day averaged over the 7 days in week 12, so combined daytime asthma symptom scores also range from 0 (best) to 5 (worst).
The measured values presented are adjusted means."|Baseline and 12 weeks|Full analysis set, which included all randomised patients who received at least one dose of trial medication, including patients with available endpoint data at week 12. Missing data in a week was imputed by the available data from the patient during that week, for weeks where data was completely missing no imputation was employed.||units on a scale||Standard Error|Mean
675907|NCT01634100|Secondary|Total Empagliflozin: Area Under the Curve 0 to Time of Last Quantifiable Data Point (AUC0-tz)|Area under the concentration-time curve of total empagliflozin (empa) in plasma over the time interval from 0 extrapolated to the time of last the quantifiable data point.|15 minutes (min) prior to the first dose and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h and 72h after the first dose|Pharmacokinetic (PK) set: The PK analysis set includes all subjects who took at least 1 dose of investigational treatment and provided at least 1 evaluable observation for at least 1 primary PK endpoint in at least 1 treatment period without any important protocol violations relevant to the evaluation of PK.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
675908|NCT01634100|Primary|Total Empa: Maximum Measured Concentration (Cmax)|Maximum measured concentration of total empa in plasma, per period.|15 minutes (min) prior to the first dose and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h and 72h after the first dose|Pharmacokinetic (PK) set: The PK analysis set includes all subjects who took at least 1 dose of investigational treatment and provided at least 1 evaluable observation for at least 1 primary PK endpoint in at least 1 treatment period without any important protocol violations relevant to the evaluation of PK.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
675909|NCT01634100|Primary|Total Empagliflozin: Area Under the Curve 0 to Infinity (AUC0-∞)|Area under the concentration-time curve of total empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity.|15 minutes (min) prior to the first dose and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h and 72h after the first dose|Pharmacokinetic (PK) set: The PK analysis set includes all subjects who took at least 1 dose of investigational treatment and provided at least 1 evaluable observation for at least 1 primary PK endpoint in at least 1 treatment period without any important protocol violations relevant to the evaluation of PK.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
675910|NCT01633944|Secondary|Change From Baseline to Week 12 in Medical Outcomes Score Sleep Subscale|Medical Outcomes Score (MOS) Sleep Scale uses 12 items to measure 6 dimensions of sleep (sleep disturbance, somnolence, sleep adequacy, snoring, awaken short of breath or headache, and quantity of sleep/optimal sleep) and an overall sleep problems index score. The scores of the dimensions (except quantity of sleep/optimal sleep) and of the sleep problem index range on a 0 to 100 scale, with higher scores reflecting more of the attribute implied by the name (eg, greater sleep disturbance, greater adequacy of sleep).|Baseline, Week 12|Analysis based on PRO population; randomized subjects who received at least 1 dose of double-blind study medication and had at least 1 post-dose assessment on PRO measures. Subjects from 1 site are excluded from the population (41). Includes only participants with MOS assessment at week 12 (n=199 buprenorphine and n=194 placebo).||units on a scale||Standard Deviation|Mean
675993|NCT01631825|Secondary|Total of UPDRS Part 2 Sum Score (Average of on State and Off State) and UPDRS Part 3 Sum Score (on State)|"Mean change (LOCF) from baseline in total of UPDRS Part 2 sum score (average of on state and off state) and UPDRS Part 3 sum score (on state).
A decrease in the scores means improvement."|Baseline, up to 54 weeks after dosing|FAS, LOCF||Scores on a scale||Standard Deviation|Mean
675911|NCT01633944|Secondary|Change From Baseline to Week 12 in Roland Morris Disability Questionnaire|Subjects assess disability due to back pain using the Roland Morris Disability Questionnaire (RMDQ) consisting of 24 statements of disability. The score of the RMDQ is the total number of items checked, ranging from 0 to 24 with higher scores indicating greater disability.|Baseline, Week 12|Analysis based on PRO population; randomized subjects who received at least 1 dose of double-blind study medication and had at least 1 post-dose assessment on PRO measures. Subjects from 1 site are excluded from the population (41). Includes only participants with RMDQ assessment at week 12 (n=193 buprenorphine and n=189 placebo).||units on a scale||Standard Deviation|Mean
675912|NCT01633944|Secondary|Patient Global Impression of Change|Subjects assessed their change in activity limitations as they relate to their painful condition since beginning treatment using the Patient Global Impression of Change (PGIC) questionnaire, a 7-point scale ranging from 1 (no change [or condition has got worse]) to 7 (a great deal better, and a considerable improvement that made all the difference)|Week 12|Analysis based on Patient-Reported Outcomes (PRO) population; randomized subjects who received at least 1 dose of double-blind medication and had at least 1 post-dose assessment on PRO measures. Subjects from 1 site excluded from population (41). Includes only participants with PGIC assessment at week 12 (n=198 buprenorphine and n=194 placebo).||units on a scale||Standard Deviation|Mean
675913|NCT01633944|Secondary|Percentage of Participants With Treatment Failure in the Double-blind Treatment Phase (up to 12 Weeks)|Treatment failure is defined as study discontinuation due to lack of efficacy or discontinuation due to adverse events in the double-blind treatment phase.|Baseline to treatment failure or end of double-blind treatment phase (up to 12 weeks)|Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication. One (1) subject did not receive double-blind study medication and an additional 41 subjects from 1 site were excluded from the population.||percentage of participants|||Number
675914|NCT01633944|Secondary|Time to Optimal Dose of Open-label Study Medication|Overall time to reach the “optimal” dose of study medication required to progress to double-blind treatment.|Up to 8 weeks in open-label titration|Analysis based on randomized subjects in the Safety population; all subjects who received at least 1 dose of study medication and were randomized into double-blind treatment.||days||Standard Deviation|Mean
675915|NCT01633944|Secondary|Number of Subjects With Rescue Medication Use|Use of analgesic rescue medication recorded in subject diary.|Week 1 to Week 12 in double-blind treatment|Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication. One (1) subject did not receive double-blind study medication and an additional 41 subjects from 1 site were excluded from the population.||participants|||Number
675916|NCT01633944|Secondary|Number of Participants With Response to Treatment (Responder) Using NRS Scale|Responders are subjects who achieve a relative reduction in pain intensity from the start of open-label titration to Week 12 in double-blind treatment. Average pain intensity over the last 24 hours was rated on an 11-point NRS ranging from 0 (no pain) to 10 (worst pain imaginable).|Prior to open-label titration to Week 12 in double-blind treatment|Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication. One (1) subject did not receive double-blind study medication and an additional 41 subjects from 1 site were excluded from the population.||participants|||Number
675917|NCT01633944|Primary|Change From Baseline to Week 12 in Average Daily Pain Intensity Scores|Change in pain intensity = average of daily pain scores from the last 7 days prior to Week 12 visit – average of daily pain scores for the last 7 days prior to randomization. Average pain intensity over the last 24 hours was rated on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).|Baseline, Week 12|Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication. One (1) subject did not receive double-blind study medication and an additional 41 subjects from 1 site were excluded from the population.||units on a scale||Standard Deviation|Mean
675918|NCT01633892|Secondary|Characterization of Adipose Stromal Cell (ASC) Function|Cell assessment will include viable stromal vascular fraction per gram of lipoaspirate.|time of surgery, up to 12 hours post-baseline|||mL of viable SVF per g of lipoaspirate||Standard Deviation|Mean
675919|NCT01633892|Secondary|Composition of SVF|Cell assessment included stromal vascular fraction composition evaluated by flow cytometry.|time of fat grafting, up to 12 hours post-baseline|||percentage of cells||Standard Deviation|Mean
675920|NCT01633892|Secondary|Measure Quality of Life in Subjects After Grafting Using Validated Psychosocial Measures.|"1) Social Avoidance and Distress Scale (SADS) uses a questionnaire including 28 true/false items, with scores ranging from 0-10. A low score is below 4, high is above 7; intermediate is between 4-7. 2) COPE scale asks the subject to indicate what he/she generally does and feels, when he/she experience stressful events. On a scale of 60-240 where the higher ends indicates the subject does this activity most frequently during stressful events; 3) The Satisfaction With Appearance Scale (SWAP) is a 14-item questionnaire, assessing both the subjective appraisal and social-behavioral components of body image, where the higher the score, the more satisfied subject is with procedure, ranging from 0-7 for a total possible score range between 0-98 ."|9 months|||units on a scale, see outcome measure de||Standard Deviation|Mean
675921|NCT01633892|Primary|Average Tissue Thickness From Baseline up to 9 Months|High resolution CT scanning with 3D reconstruction at 0, 1, 3, and 9 months|0, 1, 3, and 9 months|||mm||Standard Deviation|Mean
675922|NCT01633892|Primary|Average Fat Graft Volume Facial Form From Baseline up to 9 Months|High resolution CT scanning with 3D reconstruction at 0, 1, 3, and 9 months|0, 1, 3, and 9 months|||cc||Standard Deviation|Mean
675923|NCT01633853|Primary|The Blood Levels of Intact Parathyroid Hormone at the 24th Month of Following up.|The blood levels of intact parathyroid hormone (iPTH) at the 24th month of following up will be detected.|24 months|||pg/ml||Standard Deviation|Mean
675924|NCT01633853|Primary|The Blood Levels of Phosphorus at the 24th Month of Following up.|The blood levels of phosphorus at the 24th month of following up will be detected.|24 months|||mmol/L||Standard Deviation|Mean
675925|NCT01633853|Secondary|The Incidence Rate of Secondary Hyperparathyroidism.|Patients with the blood iPTH level higher than 300 pg/ml will be regard as sHPT. The incidence of sHPT during following up were recorded and compared between two groups.|24 months|||participants|||Number
675926|NCT01633853|Secondary|The Blood 25(OH)Vitamin D Level.|The levels of blood 25(OH)Vitamin D at the 24th month of following up.|24 months|||ng/ml||Standard Deviation|Mean
675929|NCT01633827|Primary|Model Prediction of Absence/Presence of OSA: Active Collapsibility (Vactive)|"Our published method estimates 4 important physiological traits causing OSA: 1) pharyngeal anatomy, 2) loop gain, 3) the ability of the upper airway to dilate/stiffen in response to increases in ventilatory drive, and 4) arousal threshold. Each individual's set of traits is then entered into a physiological model of OSA that graphically illustrates the relative importance of each trait in that individual and predicts OSA presence/absence.
Active collapsibility is the ventilation on no CPAP when upper airway muscle are maximally activated. It is calculated by slowing reducing CPAP from the optimal to the minimum tolerable level and rapidly dropping the CPAP to 0 for a few breaths. This trait is symbolized as Vactive (L/min)"|Subjects will be assessed on day 1 (visit 1) and up to 1 month (visit 2)|During the placebo arm, one participant did not have OSA and another exhibited predominantly central sleep apnea; both were excluded from the analysis. Subject results for the 20 remaining patients are reported here per intervention.||L/min||Standard Error|Mean
675930|NCT01633827|Primary|Model Prediction of Absence/Presence of OSA: Passive Collapsibility|"Our published method estimates 4 important physiological traits causing OSA: 1) pharyngeal anatomy, 2) loop gain, 3) the ability of the upper airway to dilate/stiffen in response to increases in ventilatory drive, and 4) arousal threshold. Each individual's set of traits is then entered into a physiological model of OSA that graphically illustrates the relative importance of each trait in that individual and predicts OSA presence/absence.
The passive collapsibility of the upper airway is quantified as the ventilation on no CPAP (atmospheric pressure) at the eupneic level of ventilatory drive when upper airway dilator muscles are relatively passive. This trait is symbolized as Vpassive (L/min)"|Subjects will be assessed on day 1 (visit 1) and up to 1 month (visit 2)|During the placebo arm, one participant did not have OSA and another exhibited predominantly central sleep apnea; both were excluded from the analysis. Subject results for the 20 remaining patients are reported here per intervention.||L/min||Standard Error|Mean
675931|NCT01633827|Primary|Model Prediction of Absence/Presence of OSA: Ventilatory Control Sensitivity (Loop Gain)|"Our published method estimates 4 important physiological traits causing OSA: 1) pharyngeal anatomy, 2) loop gain, 3) the ability of the upper airway to dilate/stiffen in response to increases in ventilatory drive, and 4) arousal threshold. Each individual's set of traits is then entered into a physiological model of OSA that graphically illustrates the relative importance of each trait in that individual and predicts OSA presence/absence.
In this table the investigators report the ventilatory control sensitivity value (Loop Gain). It is calculated dividing the increase in ventilatory drive by the steady state reduction in ventilation. The increase in ventilatory drive is measured as the ventilatory overshoot following a switch to optimal CPAP from the minimum tolerable CPAP. This trait is symbolized as steady state loop gain (LG, adimensional)"|Subjects will be assessed on day 1 (visit 1) and up to 1 month (visit 2)|During the placebo arm, one participant did not have OSA and another exhibited predominantly central sleep apnea; both were excluded from the analysis. Subject results for the 20 remaining patients are reported here per intervention.||ratio, adimensional||Standard Error|Mean
675932|NCT01633827|Primary|Model Prediction of Absence/Presence of OSA: Ventilation That Causes an Arousal From Sleep (Varousal)|"Our published method estimates 4 important physiological traits causing OSA: 1) pharyngeal anatomy, 2) loop gain, 3) the ability of the upper airway to dilate/stiffen in response to increases in ventilatory drive, and 4) arousal threshold. Each individual's set of traits is then entered into a physiological model of OSA that graphically illustrates the relative importance of each trait in that individual.
In this table the investigators report the minimum ventilation that can be tolerated before an arousal from sleep (Varousal). It is calculated by slowly reducing the CPAP level from optimum to the minimum tolerable pressure. This trait is symbolized as Varousal (L/min)"|Subjects will be assessed on day 1 (visit 1) and up to 1 month (visit 2)|During the placebo arm, one participant did not have OSA and another exhibited predominantly central sleep apnea; both were excluded from the analysis. Subject results for the 20 remaining patients are reported here per intervention.||L/min||Standard Error|Mean
675933|NCT01633814|Primary|Change in Exercise Pressor Reflex Responsiveness (Mean Blood Pressure Response (mmHg) and Muscle Sympathetic Nerve Activity Response (Burst Frequency) During Post Handgrip Ischemia.)|To estimate exercise pressor reflex responsiveness changes in blood pressure and muscle sympathetic nerve activity from rest to during a period of post handgrip ischemia will be used.|Within one week prior to and then after one month of transdermal estrogen alone, transdermal estrogen plus progesterone, progesterone alone and placebo.|Results are not available due to all members of the study having left the institution and not having made results available.|||||
675934|NCT01633814|Primary|Change in Carotid Baroreflex Sensitivity (Bpm/mmHg)|Carotid baroreflex sensitivity will be measured using the application of neck pressure and neck suction. Briefly, a variable neck pressure collar will be placed around the anterior two thirds of the neck to change carotid sinus transmural pressure.|Within one week prior to and then after one month of transdermal estrogen alone, transdermal estrogen plus progesterone, progesterone alone and placebo.|Results are not available due to all members of the study having left the institution and not having made results available.|||||
675935|NCT01633788|Secondary|Percentage of Complete Overall Ocular Discomfort Responders|Ocular symptoms of blurred vision, burning, dryness, eye pain, light sensitivity, itching, and foreign body sensation are assessed by the patient on a 5-point scale ranging from 0 = none to 4 = very severe. A patient is considered a complete overall ocular discomfort responder if the overall ocular discomfort score is 0 (indicating no overall ocular discomfort) at that visit.|Month 6|Modified intent-to-treat: all randomized and treated patients who have values for meibum quality score at randomization, at least one postrandomization visit, and data at the noted time point||Percentage of Patients|||Number
675936|NCT01633788|Secondary|Percentage of Maximum Meibum Quality Score (MMQS) Responders in the Study Eye|The MQS is assessed based on Mathers’ meibum quality secretion grading 4-point scale where: 0 = Clear excreta or clear with small particles (normal viscosity), 1 = Opaque excreta with normal viscosity, 2 = Opaque excreta with increased viscosity (gel-like), and 3 = Secretions retain shape (or secretions do not express but a toothpaste-like substance can be seen at the opening of the orifice). MMQS is calculated for each eye as the maximum of the meibum quality scores of the expressible glands within the 6 central glands of the lower eyelids. A patient is considered to be an MMQS responder at a postrandomization visit if the MMQS in the study eye is 0 or 1 (indicating normal viscosity) at that visit.|Month 6|Modified intent-to-treat: all randomized and treated patients who have values for meibum quality score at randomization, at least one postrandomization visit, and data at the noted time point||Percentage of Patients|||Number
675937|NCT01633788|Primary|Percentage of Meibum Quality Responders in the Study Eye|Meibum quality response is defined as a patient who experiences a reduction ≥ 50% in the number of meibomian glands with a Meibum Quality Score (MQS) of 2 or 3 in the study eye. The MQS is based on Mathers’ meibum quality secretion grading 4-point scale where: 0 = Clear excreta or clear with small particles (normal viscosity), 1 = Opaque excreta with normal viscosity, 2 = Opaque excreta with increased viscosity (gel-like), and 3 = Secretions retain shape (or secretions do not express but a toothpaste-like substance can be seen at the opening of the orifice).|Month 6|Modified intent-to-treat: all randomized and treated patients who have values for meibum quality score at randomization, at least one postrandomization visit, and data at the noted time point||Percentage of Patients|||Number
675938|NCT01633320|Primary|Pain Scores on a 0-10 Numeric Rating Scale (NRS)|Verbal pain scale, with 0 = no pain and 10 = worst pain imaginable. NRS<3 corresponds to no or mild pain NRS>=3 corresponds to moderate to severe pain NRS>=7 corresponds to severe pain|At arrival in PACU or 10 min after extubation|||units on a scale||Standard Deviation|Mean
675939|NCT01633320|Primary|Analgesia/Nociception Index (ANI)|The ANI is a 0-100 index estimating the parasympathetic/sympathetic balance derived from heart rate variability, measured by the PhysioDoloris monitor (MetroDoloris, Loos, France). High ANI values indicate parasympathetic predominance (no pain) while during nociception (increase in sympathetic activity), ANI value decrease to 60 or less.|At arrival in post-operative care unit (PACU) or 10 min after extubation|||units on a scale||Standard Deviation|Mean
675940|NCT01632995|Secondary|Measurement of HIV Drug Resistance Patterns Among Participants Who Become Infected||Participants were followed for 48 weeks, or up to the point of early termination|||participant with acquired HIV resistance|||Number
675941|NCT01632995|Secondary|Number of Participants Who Seroconvert||Participants were followed for 48 weeks, or up to the point of early termination|||participants|||Number
675942|NCT01632995|Primary|Measurement of PrEP Adherence by Medication Possession Ratio|Medication possession ratio is defined as the number of dispensed pills divided by the number of days between visits|Participants were followed for 48 weeks, or up to the point of early termination|Mean PrEP adherence by medication possession ratio||percent|||Number
675943|NCT01632995|Primary|Number of Male Sexual Partners||Participants were followed for 48 weeks, or up to the point of early termination|||partners||Full Range|Mean
675944|NCT01632995|Primary|Measurement of PrEP Adherence by TFV-DP Levels in DBS||Participants were followed for 48 weeks, or up to the point of early termination|DBS testing was performed in approximately 100 randomly selected participants per site, and among all African American and transgender participants, who were underrepresented in the overall sample||Percent of Participants|||Number
675945|NCT01632995|Primary|Measurement of Side Effects/Toxicities||Participants were followed for 48 weeks, or up to the point of early termination|||events|||Number
675946|NCT01632995|Primary|Duration of PrEP Use|Mean duration of interruptions|Participants were followed for 48 weeks, or up to the point of early termination|||Days|||Number
675947|NCT01632995|Primary|Duration of PrEP Use|Number of study drug interruptions|Participants were followed for 48 weeks, or up to the point of early termination|||interruptions|||Number
675948|NCT01632995|Primary|Measurement of Refusal Rate of PrEP||Measured through enrollment (Week 0)|||Participants|||Count of Participants
675949|NCT01632995|Primary|Measurement of Acceptance Rate of PrEP||Measured through enrollment (Week 0)|||Participants|||Count of Participants
675950|NCT01632904|Secondary|Percentage of Subjects Achieving a Durable Response on Individual Symptoms Scores for TSS-C||Week 48||||||
675951|NCT01632904|Secondary|Percentage of Subjects Achieving a Durable Response on TSS-C|Durable Response on TSS-C defined as a ≥ 50% improvement from baseline in TSS-C at Week 16 that was maintained at the Week 48 visit.|Week 48||||||
675952|NCT01632904|Secondary|Percentage of Subjects Achieving ≥ 50% Improvement From Baseline in the Individual Symptom Scores for TSS-C at Week 16|The TSS-C cluster includes tiredness, itching, muscle aches, night sweats, and sweats while awake.|From Baseline to Week 16|Intent-to-Treat (ITT); all subjects randomized in the study. For individual symptom scores within the TSS-C cluster, only those subjects with a baseline score of 0 and a Week 16 score of 0 or missing were excluded from the analysis.||Percentage of participants|||Number
675953|NCT01632904|Primary|Percentage of Subjects Achieving a ≥ 50% Improvement From Baseline in Total Symptom Score-Cytokine (TSS-C) at Week 16, as Measured by the Modified Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) Diary|Symptoms of polycythemia vera were assessed using a modified Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) electronic diary. Using the diary, patients rated the following symptoms on a scale from 0 (absent) to 10 (worst imaginable): tiredness, itching, muscle aches, night sweats, and sweats while awake. The total symptom score ranged from 0-50 and was calculated as the sum of the 5 symptom scores. A higher score indicates worse symptoms.|From Baseline to Week 16|Intent-to-Treat (ITT); all subjects randomized in the study. For the overall TSS-C score, only those subjects with a baseline score of 0 and a Week 16 score of 0 or missing were excluded from the analysis.||Percentage of participants|||Number
675954|NCT01632878|Primary|Number of Occurrences of Cardio-vascular Events|Such as: recurrent non fatal Myocardial Infarction (MI), sudden death, or new Congestive Heart Failure (CHF)|12 months|||events|||Number
675955|NCT01632800|Primary|Degree of Discomfort Under Applied Pulsed Magnetic Fields|Pulsed magnetic fields will be applied a total of forty-eight times to the right hand of each subject. After each time the magnet coil is pulsed, the subject will be asked if he or she notices any sensation (for example, tingling or tapping). Subjects will be asked to rate the sensation from 0 to 4, where 0 means no sensation, 1 means barely-noticeable sensation, 2 means easily noticeable sensation, 3 means unpleasant sensation, and 4 means very unpleasant sensation.|Bioeffects will be assessed within the five-minute application of each pulse sequence|||percentage of subjects with discomfort|||Number
675956|NCT01632735|Secondary|Social Support Utilization|"Self-help utilization was measured by the question: In the past 30 days, how many days did you attend self-help meetings like AA or NA to support your recovery?”"|Baseline, discahrge, 3 month follow-up, 6 month follow-up, 9 month follow-up|Intent to treat model was used to assess the effects of the intervention (mobile continuing care) compared to aftercare as usual in terms of improvements in social support service utilization over time (baseline, discharge and follow-ups: 3-, 6- and 9-months post-discharge).||days per month||Standard Deviation|Mean
675957|NCT01632735|Secondary|Recovery Confidence (Self-efficacy) Over Time|"Change/improvements in mean recovery confidence score over time (measured by question How confident are you in your ability to be completely abstinent (clean) from alcohol and drugs in the next 30 days? (units on scale included 0=not at all, 1=slightly, 2=moderately, 3=considerably, 4-extremely)."|baseline, discharge, 3-, 6-, and 9-month follow-ups|Used an intent to treat design. Examined the effects of the intervention (mobile continuing care) compared to aftercare as usual on change in recovery self-confidence over time.||units on a scale||Standard Deviation|Mean
675958|NCT01632735|Secondary|Participation in Recovery Behaviors Over Time|Recovery behaviors defined as mean number of days doing extracurricular/recovery-goal directed activities using repeated measures over time.|baseline, discharge, 3-, 6- and 9-month follow-ups|Intent to treatment model was used. Mixed modeling used to examine differences in recovery behaviors (measured by mean days doing extracurricular/recovery-goal directed activities) over time between study conditions.||days per month||Standard Deviation|Mean
675959|NCT01632735|Primary|Primary Substance Use (Defined as Substance Received Treatment for)|Primary substance use relapse was measured by urine tests (0 = negative, 1 = positive).|Baseline, discahrge, 3 month follow-up, 6 month follow-up, 9 month follow-up|An intent to treat model was used. The primary outcome measure is primary substance use measured by urine drug test at baseline, discharge as well as at 3-, 6-, and 9-month follow-ups. Study retention at discharge was 95%, 92.5% at 3 months, 86.2% at 6 months, and 82.5% at 9 months.||percentage of positive urines|||Number
675960|NCT01632709|Secondary|Pain Visual Analogue Scale (VAS)|The Pain Visual Analogue Scale (VAS) is a scale from 0-100 where 0= no pain and 100=the worst pain|VAS collected pre injection and 1 week post injection|all available data was analyzed (some subjects did not complete all outcomes)||units on a scale||Standard Deviation|Mean
675961|NCT01632709|Secondary|Change in Depression (CES-D 10)|The Center for Epidemiologic Studies Short Depression Scale (CES‐D 10) is a validated instrument that assesses depression. The CES-D 10 is a scale from 0-30 where 0= no depression and 30=the most depression|CES-D 10 collected pre injection and 1 week post injection|all available data was analyzed (some subjects did not complete all outcomes)||units on a scale||Standard Deviation|Mean
675962|NCT01632709|Secondary|Change in Perceived Anxiety (PASS)|The Pain Anxitey Symptoms Scale (PASS) is a validated instrument that assesses anxiety in.The PASS is a scale from 0-100 where 0= no anxiety and 100=the most anxiety|PASS collected pre injection and 1 week post injection|all available data was analyzed (some subjects did not complete all outcomes)||units on a scale||Standard Deviation|Mean
675963|NCT01632709|Secondary|Change in Perceived Disability (PDI)|The PDI is a seven-item validated instrument that assesses perceived disability in 7 key life areas. The Pain Disability Scale is a scale from 0-70 where 0= no disability and 70=the most disability|PDI collected pre injection and 1 week post injection|all available data was analyzed (some subjects did not complete all outcomes)||units on a scale||Standard Deviation|Mean
675964|NCT01632709|Primary|Change in Pain|Pain rating before and after injection on a 0-10 NRS pain scale (0=no pain, 10= worst pain imaginable)|Pain rating before and at 15 minutes and 1 hour post injection|all available data was analyzed (some subjects did not complete all outcomes)||units on a scale||Standard Deviation|Mean
675965|NCT01632683|Secondary|Complications|Patients will be examined for evidence of mucosal or dental injury upon intervention. Patients will be asked if they have a sore throat in the recovery room, and their medical record will be reviewed to determine if any other airway related complications were observed by the clinical team including the need for reintubation or steroid administration to reduce swelling.|1 week||||||
675966|NCT01632683|Secondary|Use of Adjuncts|The need for use of a gum-elastic bougie or external laryngeal manipulation to facilitate tube placement will be measured by the study team.|1 week||||||
675967|NCT01632683|Secondary|Laryngeal View|Laryngeal view is defined by the modified Cormack and Lehane scale (1-4) and is assessed by the clinician and the study team.|1 week||||||
675968|NCT01632683|Secondary|Intubation Time|Intubation time is defined as the time from blade insertion to first return of end-tidal carbon dioxide|1 week||||||
675969|NCT01632683|Primary|Intubation Success Rate|Success rate is defined as a single blade insertion with successful tracheal tube placement confirmed by return of end-tidal carbon dioxide|1 week|||participants|||Number
675970|NCT01632423|Secondary|Patients Who Will Continue Use of Lumigan® After 14 Weeks|Patients who will continue use of Lumigan® after 14 weeks was assessed as Yes or No.|14 Weeks|All enrolled patients with complete data for this outcome measure||Participants|||Number
675971|NCT01632423|Secondary|Patients Who Discontinued Use of Lumigan® Prior to 14 Weeks|Patients who discontinued Lumigan® prior to 14 weeks was assessed as Yes or No.|14 Weeks|All enrolled patients with complete data for this outcome measure||Participants|||Number
675972|NCT01632423|Secondary|Physician Assessment of Tolerability Using a 4-Point Scale|Physician assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed as good and very good combined are reported.|14 Weeks|All enrolled patients with complete data for this outcome measure||Participants|||Number
675973|NCT01632423|Secondary|Patient Assessment of Tolerability Using a 4-Point Scale|Patient assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed as good and very good combined are reported.|14 Weeks|All enrolled patients with complete data for this outcome measure||Participants|||Number
675974|NCT01632423|Primary|Change From Baseline in Intraocular Pressure (IOP)|IOP is a measurement of the fluid pressure inside the eye. A negative change from baseline indicates an improvement.|Baseline, 14 Weeks|All enrolled patients with complete data for this outcome measure||Millimeters of Mercury (mmHg)||Inter-Quartile Range|Median
675975|NCT01632267|Secondary|Number of Disability Claims|Number of disabiity claims during study window|During the one year study window (April 1, 2010 to April 1, 2011)||||||
675976|NCT01632267|Secondary|Number of Medical Absence Days|Number of medical absence days during study window|During the one year study window (April 1, 2010 to April 1, 2011)||||||
675977|NCT01632267|Primary|Number of Outpatient Visits|Number of outpatient healthcare visits during study window|During the one year study window (April 1, 2010 to April 1, 2011)|||units on a scale||Standard Deviation|Mean
675978|NCT01632215|Primary|Pain Intensity|Numerical score from 0 to 10; zero means no pain and 10 is the more intense pain|6 months|||units on a scale||Standard Deviation|Mean
675979|NCT01632215|Secondary|Chronic Pain|Number of neuropathic pain and complex regional syndrome pain after 6 months|6 months||||||
675980|NCT01632150|Secondary|Percentage of All Participants Who Received Treatment Without Cyclophosphamide and Had 1 Dose Reduction or Discontinued Due to an Adverse Event|Elotuzumab dose reduction was not permitted. Thalidomide dose reduction, delay, interruptions, or discontinuation was permitted in the event of toxicity. Dexamethasone dose reduction was also permitted in the event of toxicity and in the setting of infusion reactions;dose delays were allowed as clinically indicated at the discretion of the investigator.|From the first dose of study drug until the earlier of discontinuation from E-Td or the time when cyclophosphamide was initiated|All participants who received thalidomide + elotuzumab + dexamethasone regimen, from first dose of study drug until discontinuation or until cyclophosphamide was initiated, whichever came first.||Percentage of participants||95% Confidence Interval|Number
675981|NCT01632150|Primary|Percentage of All Participants Who Received Treatment Without Cyclophosphamide and Had Grade 3 or Higher Nonhematologic Adverse Events (AEs)|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or unknown relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.|From the first dose of study drug until the earlier of discontinuation from E-Td or the time when cyclophosphamide was initiated|All participants who received thalidomide + elotuzumab + dexamethasone regimen, from first dose of study drug until discontinuation or until cyclophosphamide was initiated, whichever came first.||Percentage of participants||90% Confidence Interval|Number
675982|NCT01632150|Secondary|Percentage of All Participants Who Received Treatment Including Cyclophosphamide and Had 1 Dose Reduction or Discontinued Due to an Adverse Event|Elotuzumab dose reduction was not permitted. Thalidomide dose reduction, delay, interruptions, or discontinuation was permitted in the event of toxicity. Dexamethasone dose reduction was also permitted in the event of toxicity and in the setting of infusion reactions;dose delays were allowed as clinically indicated at the discretion of the investigator. Cyclophosphamide dose reduction, delay, interruption, or discontinuation was permitted in the event of toxicity.|From the first dose of study drug until the last dose of treatment, including cyclophosphamide treatment|All participants who received thalidomide, elotuzumab, and dexamethasone (40), including those who had cyclophosphamide added to the regimen (11).||Percentage of participants||95% Confidence Interval|Number
675983|NCT01632150|Primary|Percentage of Participants Who Received Treatment Including Cyclophosphamide and Had Grade 3 or Higher Nonhematologic Adverse Events (AEs)|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or unknown relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.|From the first dose of study drug until the last dose of treatment, including cyclophosphamide treatment|All participants who received thalidomide, elotuzumab, and dexamethasone (40) including those who had cyclophosphamide added to the regimen (11).||Percentage of participants||90% Confidence Interval|Number
675984|NCT01632020|Primary|Mucosal Apoptotic Status of CRC Tumor and Adjacent Normal Tissue Following Metformin Therapy||10-21 days|Data not collected due to inadequate subject accrual. Analysis not completed.|||||
675985|NCT01632020|Primary|Proliferation Status of CRC Tumor and Adjacent Normal Tissue Following Metformin Therapy||10-21 days|Data not collected due to inadequate subject accrual. Analysis not completed.|||||
675986|NCT01631929|Primary|Time to Achieve Patient Stabilization|"Time needed to achieve patient stabilization defined by:
Plasmatic glucose < 250 mg/dl
Blood pH > 7.3
Plasmatic bicarbonate > 15 mmol/L"|Participants were followed for the duration of ketoacidosis (an expected average of 12 hours)|||Hours||95% Confidence Interval|Mean
675987|NCT01631864|Secondary|Number of Participants With Adverse Events, Serious Adverse Events and Deaths|Adverse event monitoring was conducted throughout the study.|8 weeks|Safety Analysis Set (SAS): The SAS included all randomized participants who received at least one dose of study drug.||Participants|||Number
675988|NCT01631864|Secondary|Oxidative Metabolism|Oxidative metabolism was assessed by indirect calorimetry.|57 days|Pharmacodynamic Analysis Set (PDS): Only participants from the PDS, who had both baseline and day 56 values, were included in the analysis. The PDS included all randomized participants who received at least one dose of study drug and had no protocol deviations with relevant impact on PD data.||carbon dioxide to oxygen ratio||95% Confidence Interval|Least Squares Mean
675989|NCT01631864|Secondary|Local Adipose Tissue Lipolysis, Glycerol Concentrations|Lipolysis was assessed through subcutaneous adipose tissue microdialysis. The actual measure type is adjusted geometric mean.|57 days|Pharmacodynamic Analysis Set (PDS): Only participants from the PDS, who had both baseline and day 56 values, were included in the analysis. The PDS included all randomized participants who received at least one dose of study drug and had no protocol deviations with relevant impact on PD data.||micro mol/L||95% Confidence Interval|Geometric Mean
675990|NCT01631864|Primary|Change From Baseline in Insulin Sensitivity Index|The insulin sensitivity index was assessed by hyperinsulinemic euglycemic clamp (HEGC). A positive change from baseline indicates improvement.|baseline, 8 weeks|Pharmacodynamic Analysis Set (PDS): Only participants from the PDS, who had both baseline and day 56 values, were included in the analysis. The PDS included all randomized participants who received at least one dose of study drug and had no protocol deviations with relevant impact on PD data.||ug/kg*min/(mmol/L*pmol/L)||95% Confidence Interval|Mean
675991|NCT01631825|Secondary|Each Item of UPDRS Part 4|The percentage of subjects with elevated scores for each item of UPDRS Part 4. The data at week 52 is shown.|Baseline, up to 54 weeks after dosing.|FAS, LOCF||Percentage of Participants|||Number
675992|NCT01631825|Secondary|Each Item of UPDRS Part 3 (on State)|The percentage of subjects with elevated scores for each item of UPDRS Part 3 (on state). The data at week 52 is shown.|Baseline, up to 54 weeks after dosing.|FAS, LOCF||Percentage of Participants|||Number
675994|NCT01631825|Secondary|Each Item of UPDRS Part 2 (Average of on State and Off State)|The percentage of subjects with elevated scores for each item of UPDRS Part 2 (average of on state and off state). The data at week 52 is shown.|Baseline, up to 54 weeks after dosing.|FAS, LOCF||Percentage of Participants|||Number
675998|NCT01631825|Secondary|The Modified Hoehn & Yahr Severity of Illness|"Change (LOCF) from baseline in the Modified Hoehn & Yahr Severity of Illness. The Modified Hoehn & Yahr criteria are measured on the following 8-point scale for staging: 0, No signs of disease; 1, Unilateral disease; 1.5, Unilateral plus axial involvement; 2, Bilateral disease without impairment of balance; 2.5, Mild bilateral disease with recovery on pull test; 3, Mild to moderate bilateral disease, some postural instability, physically independent 4, Severe disability, still able to walk or stand unassisted; and 5, Wheelchair bound or bedridden unless aided.
The data at week 52 is shown."|Baseline, up to 54 weeks after dosing.|FAS, LOCF||Percentage of participants|||Number
675999|NCT01631825|Secondary|Total of UPDRS Part 1 Sum Score, UPDRS Part 2 Sum Score (Average of on State and Off State), UPDRS Part 3 Sum Score (on State), and UPDRS Part 4 Sum Score|"Mean change (LOCF) from baseline in total of UPDRS Part 1 sum score, UPDRS Part 2 sum score (average of on state and off state), UPDRS Part 3 sum score (on state), and UPDRS Part 4 sum score.
A decrease in the scores means improvement."|Baseline, up to 54 weeks after dosing|FAS, LOCF||Scores on a scale||Standard Deviation|Mean
676000|NCT01631825|Secondary|UPDRS Part 4 Sum Score|"Mean change (LOCF) from baseline in UPDRS Part 4 sum score.
UPDRS sub-scale Part 4 assesses 11 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score.
A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, up to 54 weeks after dosing|FAS, LOCF||Scores on a scale||Standard Deviation|Mean
676001|NCT01631825|Secondary|UPDRS Part 2 Sum Score (Off State)|Mean change (LOCF) from baseline in UPDRS Part 2 sum score (off state). A decrease in the scores means improvement.|Baseline, up to 54 weeks after dosing|FAS, LOCF||Scores on a scale||Standard Deviation|Mean
676002|NCT01631825|Secondary|UPDRS Part 2 Sum Score (On State)|Mean change (LOCF) from baseline in UPDRS Part 2 sum score (on state). A decrease in the scores means improvement.|Baseline, up to 54 weeks after dosing|FAS, LOCF||Scores on a scale||Standard Deviation|Mean
676003|NCT01631825|Secondary|UPDRS Part 1 Sum Score|"Mean change (LOCF) from baseline in UPDRS Part 1 sum score.
UPDRS sub-scale Part 1 assesses 4 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, up to 54 weeks after dosing|FAS, LOCF||Scores on a scale||Standard Deviation|Mean
676004|NCT01631825|Secondary|"Absolute Time Spent Off"|"Mean number of hours in off state during a 24-hour period."|Baseline, up to 54 weeks after dosing|FAS subjects with measurable off time at baseline, LOCF||Hours||Standard Deviation|Mean
676005|NCT01631825|Secondary|UPDRS Part 2 Sum Score (Average of on State and Off State)|"Mean change (LOCF) from baseline in UPDRS Part 2 sum score (average of on state and off state).
UPDRS sub-scale Part 2 assesses 13 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, up to 54 weeks after dosing|FAS, LOCF||Scores on a scale||Standard Deviation|Mean
676006|NCT01631825|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 Sum Score|"Mean change (LOCF) from baseline in UPDRS Part 3 sum score (on state).
UPDRS is a scale for monitoring Parkinson's Disease-related disability and impairment. The UPDRS consists of the following four sub-scales. Part 1: Mentation, Part 2: Activities of Daily Living, Part 3: Motor, Part 4: Complications. Part 3 assesses 14 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, Up to 54 weeks after dosing|Full analysis set (FAS), last observation carried forward (LOCF)||Scores on a scale||Standard Deviation|Mean
676007|NCT01631825|Primary|Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters|"The safety of the long-term SPM 962 treatment was examined based on the incidence and severity of AEs, vital signs, and laboratory parameters.
AEs of special interest (1-3) are defined as below:
sudden onset of sleep
obsessive-compulsive disorder or impulse-control disorder
hallucination, delusion
Application site reaction is scored as -, ±, +, ++, +++, or ++++. More + indicates a greater severity of symptoms. The worst score obtained throughout the evaluation period was to be assessed."|Up to 55 weeks after dosing|Safety set (SS)||participants|||Number
676008|NCT01631812|Primary|Skin Irritation Score of the Application Site|"Skin irritation score of the application site were evaluated according to the criteria below. The worst score throughout the treatment period was used in the analysis.
-: no reaction, ±: mild erythema, +: erythema, ++: erythema and Oedema, +++: erythema and oedema and rash papular, or serous papule, or vesicles, ++++: bullosum"|Up to 55 weeks after dosing|SS||participants|||Number
676009|NCT01631812|Secondary|"Absolute Time Spent Off"|"Mean number of hours in off state during a 24-hour period."|Up to 54 weeks after dosing|FAS subjects with “off state” at baseline||Hours||Standard Deviation|Mean
676010|NCT01631812|Secondary|UPDRS Part 2 Sum Score|Mean change (LOCF) from baseline in UPDRS Part 2 sum score (average scores of on state and off state) up to 54 weeks after dosing UPDRS sub-scale Part 2 assesses 13 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement.|Baseline, Up to 54 weeks after dosing|||Scores on a scale||Standard Deviation|Mean
676011|NCT01631812|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 Sum Score|Mean change (LOCF) from baseline in UPDRS Part 3 sum score (on state) up to 54 weeks after dosing UPDRS is a scale for monitoring Parkinson's Disease-related disability and impairment. The UPDRS consists of the following four sub-scales. Part 1: Mentation, Part 2: Activities of Daily Living, Part 3: Motor, Part 4: Complications. Part 3 assesses 14 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement.|Baseline, Up to 54 weeks after dosing|Full analysis set (FAS), last observation carried forward (LOCF)||Scores on a scale||Standard Deviation|Mean
676012|NCT01631812|Primary|Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters.|"Incidence and severity of adverse events, vital signs, and laboratory parameters after dosing.
*decrease in difference between supine and standing systolic blood pressure"|Up to 55 weeks after dosing|Safety set (SS)||participants|||Number
676347|NCT01625910|Secondary|Sugar Sweetened Beverages|Change in reported intake of sugar sweetened beverages|Three months|Intention to treat analysis||cans per day||Standard Error|Mean
676013|NCT01631682|Primary|Change From Baseline Skin Conductance Response|Skin conductance response (SCR) is the change in skin conductance level in response to a stimulus. We compared the SCR to a non-treated conditioned stimulus (CS+N) with the SCR to a treated conditioned stimulus (CS+R) by creating a difference score (CS+R - CS+N) for the day 3 data. Day 3 is 48 hours after the fear-conditioning procedure and serves as the primary measure of whether the treatment had an effect. SCR was measured in microSiemens; the SCR difference score reflects a change in microSiemens.|48hrs|||microSiemens||Standard Deviation|Mean
676014|NCT01631630|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 31 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
676015|NCT01631630|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 28 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
676016|NCT01631630|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 24 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
676017|NCT01631630|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 21 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
676018|NCT01631630|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 17 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
676019|NCT01631630|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 14 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
676020|NCT01631630|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 10 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
676021|NCT01631630|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 7 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
676022|NCT01631630|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 3 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
676023|NCT01631630|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 1 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
676368|NCT01625507|Secondary|Change in Perceived Dietary Adherence Questionnaire Score|Questionnaire assessing self-reported adherence to 9 criteria, whose individual scores (range 0-7) are summed to get the total score. Maximum total score is 63. Minimum total score is 0. A higher score means higher dietary adherence.|4 months|||units on a scale||95% Confidence Interval|Mean
676024|NCT01631630|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 31 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
676025|NCT01631630|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 28 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
676026|NCT01631630|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 24 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
676027|NCT01631630|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 21 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
676028|NCT01631630|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 17 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
676029|NCT01631630|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 14 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
676030|NCT01631630|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 10 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
676031|NCT01631630|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 7 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
676032|NCT01631630|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 3 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
676110|NCT01629797|Primary|Number of Correct Responses to Questionnaire Items Immediately Before and After and Educational Lecture|In order to evaluate the immediate effect of an educational lecture about acne, subjects completed a questionnaire to assess knowledge about acne immediately before and after the educational lecture. The number of correct responses to each questionnaire item was calculated pre- and post-educational lecture.|immediately before and after an educational lecture|||participants|||Number
676033|NCT01631630|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 1 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
676034|NCT01631630|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 31 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
676035|NCT01631630|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 28 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
676036|NCT01631630|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 24 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
676037|NCT01631630|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 21 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
676038|NCT01631630|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 17 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
676039|NCT01631630|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 14 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
676040|NCT01631630|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 10 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
676041|NCT01631630|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 7 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
676089|NCT01630135|Secondary|Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Investigator|The investigator evaluated the participant's overall response to therapy (defined as improvement in the symptoms of allergic rhinitis) compared with Visit 2 (start of the treatment period), using the following 7-point categorical scale: 1=significantly improved, 2=moderately improved, 3=mildly improved, 4=no change, 5=mildly worse, 6=moderately worse, and 7=significantly worse.|Week 2/EW|FAS||participants|||Number
676042|NCT01631630|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 3 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
676043|NCT01631630|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 1 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
676044|NCT01631630|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|90 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||Units on a scale||Standard Error|Least Squares Mean
676045|NCT01631630|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|75 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||Units on a scale||Standard Error|Least Squares Mean
676046|NCT01631630|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|60 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||Units on a scale||Standard Error|Least Squares Mean
676047|NCT01631630|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|45 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||Units on a scale||Standard Error|Least Squares Mean
676048|NCT01631630|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|30 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||Units on a scale||Standard Error|Least Squares Mean
676049|NCT01631630|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|5 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||Units on a scale||Standard Error|Least Squares Mean
676050|NCT01631630|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||Units on a scale||Standard Error|Least Squares Mean
676051|NCT01631630|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes prior to the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||Units on a scale||Standard Error|Least Squares Mean
676052|NCT01631630|Primary|Alcohol Craving in Response to the Lipopolysaccharide Challenge|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|6 hours after the subject received an intravenous bolus of lipopolysaccharide, which occurred on Day 25 or Day 32 of the treatment period|The analyses included only those subjects who completed both the lipopolysaccharide and placebo challenge sessions||Units on a scale||Standard Error|Least Squares Mean
676369|NCT01625507|Secondary|Change in Blood Biomarkers|blood lipids: triglyceride, total cholesterol, LDL-cholesterol, HDL-cholesterol|4 months|||mg/dL||95% Confidence Interval|Mean
676053|NCT01631630|Primary|Alcohol Craving in Response to the Lipopolysaccharide Challenge|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|5 hours after the subject received an intravenous bolus of lipopolysaccharide, which occurred on Day 25 or Day 32 of the treatment period|The analyses included only those subjects who completed both the lipopolysaccharide and placebo challenge sessions||Units on a scale||Standard Error|Least Squares Mean
676054|NCT01631630|Primary|Alcohol Craving in Response to the Lipopolysaccharide Challenge|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|4 hours after the subject received an intravenous bolus of lipopolysaccharide, which occurred on Day 25 or Day 32 of the treatment period|The analyses included only those subjects who completed both the lipopolysaccharide and placebo challenge sessions||Units on a scale||Standard Error|Least Squares Mean
676055|NCT01631630|Primary|Alcohol Craving in Response to the Lipopolysaccharide Challenge|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|3 hours after the subject received an intravenous bolus of lipopolysaccharide, which occurred on Day 25 or Day 32 of the treatment period|The analyses included only those subjects who completed both the lipopolysaccharide and placebo challenge sessions||Units on a scale||Standard Error|Least Squares Mean
676056|NCT01631630|Primary|Alcohol Craving in Response to the Lipopolysaccharide Challenge|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|2 hours after the subject received an intravenous bolus of lipopolysaccharide, which occurred on Day 25 or Day 32 of the treatment period|The analyses included only those subjects who completed both the lipopolysaccharide and placebo challenge sessions||Units on a scale||Standard Error|Least Squares Mean
676057|NCT01631630|Primary|Alcohol Craving in Response to the Lipopolysaccharide Challenge|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|1 hour after the subject received an intravenous bolus of lipopolysaccharide, which occurred on Day 25 or Day 32 of the treatment period|The analyses included only those subjects who completed both the lipopolysaccharide and placebo challenge sessions||Units on a scale||Standard Error|Least Squares Mean
676058|NCT01631630|Primary|Alcohol Craving in Response to the Lipopolysaccharide Challenge|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes prior to the subject receiving an intravenous bolus of lipopolysaccharide, which occurred on Day 25 or Day 32 of the treatment period|The analyses included only those subjects who completed both the lipopolysaccharide and placebo challenge sessions||Units on a scale||Standard Error|Least Squares Mean
676059|NCT01631630|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|90 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||Units on a scale||Standard Error|Least Squares Mean
676060|NCT01631630|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|75 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||Units on a scale||Standard Error|Least Squares Mean
676061|NCT01631630|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|60 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||Units on a scale||Standard Error|Least Squares Mean
676062|NCT01631630|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|45 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||Units on a scale||Standard Error|Least Squares Mean
676063|NCT01631630|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|30 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||Units on a scale||Standard Error|Least Squares Mean
676370|NCT01625507|Secondary|Body Composition|body fat and fat-free mass|3 months|||percentage change from baseline||95% Confidence Interval|Mean
676064|NCT01631630|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||Units on a scale||Standard Error|Least Squares Mean
676065|NCT01631630|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|5 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||Units on a scale||Standard Error|Least Squares Mean
676066|NCT01631630|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes prior to the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||Units on a scale||Standard Error|Least Squares Mean
676067|NCT01631435|Primary|Per-subject Diagnostic Yield of the PillCam Platform With the CD Capsule Within the Terminal Ileum and Colon as Compared to the Ileocolonoscopy Diagnostic Yield Within the Terminal Ileum and Colon|"the primary outcome will be evalluated as follow: The number of subjects having active Crohn's disease in their terminal ileum and / or colon as detected by the PillCam Platform with the CD capsule and ileocolonoscopy.
The analysis related to the primary endpoint was applied for the terminal ileum and colon only due to the limited access of ileocolonoscopy.
Each patient was classified as follows:
Active Crohn's disease is likely
Active Crohn's disease is NOT likely
“Active Crohn’s disease” included the followings lesions:
Aphthous ulceration
Ulcers (other than Aphthous)
Bleeding
Inflammatory stricture Lesions other than the above list were classified as “Non active Crohn’s disease.”"|All the end points and outcomes measures will be evaluated within 4 months from end of enrollment|subjects with symptoms associated with Crohn's disease||number of subjects|||Number
676068|NCT01631331|Secondary|Tumor Size Measurements Before and After Short Term Vismodegib Treatment|We measured the length and width of all tumors (target and non-target) before and after vismodegib treatment.|4 months (average)|6 of the 11 patients who completed the study had multiple BCCs. We followed 13 target BCCs and 30 non-target BCCs for potential tumor size change from these patients.||percentage change in tumor size|basal cell carcinomas|95% Confidence Interval|Mean
676069|NCT01631331|Secondary|Tumor Recurrence Rate of Treated BCCs|Recurrence rate of BCCs during a 22 month average (range 12 to 28 months) follow up period.|average of 22 months|11 patients completed the trial and 13 target BCCs were excised.||BCCs|BCCs||Count of Units
676070|NCT01631331|Secondary|Number of Tumors Demonstrating Histologic Cure|Determination of histologic cure (no residual BCC on the ﬁrst piece of excised tissue) post serial sectioning of parafﬁn embedded Mohs specimens|Average of 4 months|Patients each had 1 to 2 target BCCs identified at baseline for surgical excision and were treated with vismodegib for an average of 4 months. Only target lesions are included in this analysis.||BCCs|BCCs||Count of Units
676071|NCT01631331|Primary|Percent Change in Surgical Defect Area After the Treatment Period Using Calipers and Photographs Was Calculated|At baseline, we selected 1 to 2 tumors per patient for surgery (13 target tumors selected). At baseline,1 Mohs surgeon measured the estimated surgical defect area around the target tumor. For tumors to be excised by Mohs we defined estimated surgical defect as the tumor size plus a 2-mm circumferential margin, presuming tumor clearance after a Mohs stage-1 excision. For the tumor undergoing standard (non-Mohs) excision, we used tumor size plus a standard 4-mm margin11 for the estimated surgical defect. On the day of the surgery, we measured the surgical defect area as the final tumor-free defect after the Mohs procedure or non-Mohs excision immediately before closure. We used the Image J software program (National Institutes of Health, Bethesda, MD) to calculate tumor area (cm2). Only target tumors are included in this analysis.|average of 4 months|Only patients who were treated with vismodegib for an average of 4 months were included in our analysis. Only target tumors are included in this analysis.||percentage size change from baseline|BCCs|95% Confidence Interval|Mean
676072|NCT01631227|Primary|Assess the Therapeutic Equivalence of Eprosartan (a New Formulation Containing Only the Active Moiety Eprosartan) With Eprosartan Mesylate (Currently Marketed Formulation) on Change of Sitting Diastolic Blood Pressure (DBP) From Baseline|Change from baseline of diastolic blood pressure (DBP), sitting|8 weeks|Full analysis subject sample||mmHg||Standard Deviation|Least Squares Mean
676073|NCT01631149|Secondary|Nausea and Vomiting|"Using a yes - no questionnaire, the patients will be asked whether they are nauseated or not or whether they vomited. In fact yes indicates the nr of participants.
No statistical analysis was performed."|Measurements will be made during the stay in the operating room for an average period of 3 hours|||participants|||Number
676074|NCT01631149|Secondary|Postoperative Sedation Score|"Using a 5-point sedation scale, sedation levels will be obtained throughout the postoperative period.
0 = wide awake 5= severely sedated, The sedation data were averaged over time."|Measurements will be made during the stay in the operating room for an average period of 3 hours|||units on a scale (0-5)||Standard Error|Mean
676075|NCT01631149|Secondary|Post-operative Pain|"Using a 10 cm visual analogue score pain relief score will be measured. 0 = no pain 10 = most severe pain
No statistical analysis was performed!"|measurements are made in the recovery room following surgery for an average prior of 1 hour|The pain data were averaged over time and compared by t-test between groups||units on a scale (0-10 cm)||Standard Deviation|Mean
676076|NCT01631149|Secondary|Breathing|"In the recovery room the respiratory rate will be measured continuously using the Respir8 respiratory rate monitor. The data will be recorded on the CRF at 15 min intervals.
Breathing rate units are number of breaths as measured in 1 min.
Comparison by t-test: NS between treatments"|Measurements will be made during the stay in the recovery room for an average period of 3 hours|In each subject the scores over time were averaged and a comparison between treatments was performed using a t-test||breaths per min||Standard Deviation|Mean
676077|NCT01631149|Primary|Surgical Rating Scale|"During the procedure, the surgical condition will be scored by the surgeon using a 5-point surgical rating scale. In order to reduce variability in the surgical rating all surgeries will be performed by one single surgeon. The rating scale will be a 5-point ordinal scale ranging from 1 = poor condition to 5 = optimal surgical conditions. The surgeon will score the condition at 15 minute intervals. In case of a sudden change in surgical conditions additional scores will be added to the case record form. If conditions are poor (score 1 or 2), muscle relaxation will be increased, a score of 1 will be used.
In each subject the scores over time were averaged and a comparison between treatments was performed using a t-test"|Measurements will be made during the stay in the operating room for an average period of 3 hours|Each participant that was dosed was analyzed||units on a scale (1-5)||Standard Deviation|Mean
676078|NCT01631110|Primary|Geometric Mean Titer|"GMT of HI antibodies and fold-increase in GMT (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA Note for guidance on harmonisation of requirements for influenza vaccines, 1997)"|Day 22 +/- 2 days|Intent-to-treat, vaccinated subjects with available pre- and post-vaccination titers||GMT fold increase from baseline||95% Confidence Interval|Number
676079|NCT01631110|Primary|Seroconversion|"Seroconversion rate, defined as proportion of subjects with ≥4-fold increase in HI antibody titer and with a titer of ≥1:40 (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA Note for guidance on harmonisation of requirements for influenza vaccines, 1997)"|Day 22 +/- 2 days|Intent-to-treat population, vaccinated subjects with available pre- and post-vaccination titers||percentage of subjects||95% Confidence Interval|Number
676080|NCT01631110|Secondary|Number of Participants With Local and Systemic Adverse Events, as a Measure of Safety and Tolerability|"Solicited local and systemic AEs, Unsolicited AEs
Unsolicited AEs were collected from baseline (Day 1) to 3 weeks after vaccination (Day 22 ± 2 days).
Solicited local and systemic AEs were collected by subjects diary from Day 1 (day of vaccination) to Day 4"|Baseline (Day 1) and 3 weeks after vaccination (Day 22 ± 2 days)|Safety population, all vaccinated subjects||Participants|||Number
676081|NCT01631110|Primary|Seroprotection|"Seroprotection rate, defined as proportion of subjects with HI antibody titer ≥1:40 (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA Note for guidance on harmonisation of requirements for influenza vaccines, 1997)"|Day 22 +/- 2 days|Intent-to-treat, vaccinated subjects with available pre- and post-vaccination titers||percentage of subjects||95% Confidence Interval|Number
676082|NCT01631071|Primary|Geometric Mean Titer|"GMT of HI antibodies and fold-increase in GMT (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA Note for guidance on harmonisation of requirements for influenza vaccines, 1997)"|Day 22 +/- 2 days|Intent-to-treat, vaccinated subjects with available pre- and post-vaccination titers||GMT fold increase from baseline||95% Confidence Interval|Number
676083|NCT01631071|Primary|Seroconversion|"Seroconversion rate, defined as proportion of subjects with ≥4-fold increase in HI antibody titer and with a titer of ≥1:40 (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA Note for guidance on harmonisation of requirements for influenza vaccines, 1997)"|Day 22 +/- 2 days|Intent-to-treat, vaccinated subjects with available pre- and post-vaccination titers||percentage of subjects||95% Confidence Interval|Number
676084|NCT01631071|Secondary|Number of Participants With Local and Systemic Adverse Events, as a Measure of Safety and Tolerability|"Solicited local and systemic AEs, Unsolicited AEs
Unsolicited AEs were collected from baseline (Day 1) to 3 weeks after vaccination (Day 22 ± 2 days).
Solicited local and systemic AEs were collected by subjects diary from Day 1 (day of vaccination) to Day 4"|Baseline (Day 1) and 3 weeks after vaccination (Day 22 ± 2 days)|||participants|||Number
676085|NCT01631071|Primary|Seroprotection|"Seroprotection rate, defined as proportion of subjects with HI antibody titer ≥1:40 (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA Note for guidance on harmonisation of requirements for influenza vaccines, 1997)"|Day 22 +/- 2 days|Intent-to-treat, vaccinated subjects with available pre- and post-vaccination titers||percentage of subjects||95% Confidence Interval|Number
676086|NCT01630694|Secondary|Mean Tongue Volume|The midsagittal scans were used to measure the cross-sectional area of the tongue. Transverse scans obtained in the midsection of the tongue (at the glossal end of the genioglossus muscle) provided a measure of the tongue width, which was measured between the most distant points on its upper surface. The tongue volume was derived from the multiplication of the midsagittal cross-sectional area by the tongue width.|end of study approximately one year|only 6 patients in each group were analyzed because the remaining patients were not eligible for analysis based on a review of their electronic medical chart||cubic centimeters||Standard Deviation|Mean
676087|NCT01630694|Primary|Mean Hyomental Distance Ratio|A curved low-frequency transducer and a Flex focul 400 ultrasound system were used to visualize the tongue and shadows of the hyoid bone and mandible. Midsagittal and coronal/transverse scans from the ultrasound were analyzed using ImageJ. The hyomental distances in the neutral and heal-extended positions were measured from the upper border of the hyoid bone to the lower border of the mentum. The ratio is defined as the ratio of the hyomental distance at the extreme of head extension to that in the neutral position.|end of study approximately one year|only 6 patients in each group were analyzed because the remaining patients were not eligible for analysis based on a review of their electronic medical chart||ratio||Standard Deviation|Mean
676088|NCT01630135|Secondary|Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Participant’s Parent/Guardian or the Participant|The participant's parent/guardian who signed the ICF or the participant themself evaluated the participant's overall response to therapy (defined as improvement in the symptoms of allergic rhinitis) compared with Visit 2 (start of the treatment period), using the following 7-point categorical scale: 1=significantly improved, 2=moderately improved, 3=mildly improved, 4=no change, 5=mildly worse, 6=moderately worse, and 7=significantly worse.|Week 2/EW|FAS||participants|||Number
676371|NCT01625507|Secondary|Change in Body Mass Index|Actual weight and height used to calculate BMI pre- and post-intervention|4 months|||kg/m2||95% Confidence Interval|Mean
676090|NCT01630135|Secondary|Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW|Rhinoscopy was assessed by the investigator by scoring swelling of inferior turbinate mucosa (SOITM) scored as 0 (none), 1 (possible to see center of the middle turbinate), 2 (between 3 and 1), or 3 (impossible to see middle turbinate); color of inferior turbinate mucosa (COITM) scored as 0 (normal), 1 (pink), 2 (red), or 3 (pale); quantity of nasal discharge (QTND) scored as 0 (none), 1 (small amount adhered), 2 (between 3 and 1), or 3 (filled); and quality of nasal discharge (QLND) scored as 0 (none), 1 (pyoid), 2 (viscous), or 3 (watery).|Baseline, Week 1, and Week 2/Early Withdrawal (EW)|FAS. Participants who were withdrawn before Visit 3 (Week 1) were not included in the analysis for Week 1.||participants|||Number
676091|NCT01630135|Secondary|Mean Change From Baseline in the Score of Troubles With Daily Life Over the Entire Treatment Period, at Week 1, and at Week 2|The participant's parent/guardian who signed the ICF or the participant themself scored the participant's troubles with daily life once daily using the following scale: 0, None; 1, Few troubles; 2, Intermediate between 3 and 1; or 3, Painful and complicating daily life. The mean of the Baseline period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (Weeks 1 and 2), Week 1, and Week 2. For each assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline through the entire treatment period (2 weeks), Week 1, and Week 2|FAS. Only those participants who were available for assessment at both Baseline and the indicated assessment period were analyzed. Participants were analyzed for the entire treatment period if they had an assessment on any day during Week 1 and Week 2. The analysis was based on an ANCOVA with a model adjusting for Treatment, Baseline, Age, and Sex.||Scores on a scale||Standard Error|Least Squares Mean
676092|NCT01630135|Secondary|Mean Change From Baseline in the Individual Ocular Symptom Scores (Eye Itching, Tearing, and Redness) Over the Entire Treatment Period, at Week 1, and at Week 2|Symptoms of eye itching, tearing, and redness were scored by the participant's parent/guardian who signed the ICF or the participant themself using a scale of 0, 1, 2, or 3 (a larger score indicates more severe symptoms) and were recorded in the participant's diary. The mean of the Baseline period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (Weeks 1 and 2), Week 1, and Week 2. For each assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline through the entire treatment period (2 weeks), Week 1, and Week 2|FAS. Only those participants who were available for assessment at both Baseline and the indicated assessment period were analyzed. Participants were analyzed for the entire treatment period if they had an assessment on any day during Week 1 and Week 2. The analysis was based on an ANCOVA with a model adjusting for Treatment, Baseline, Age, and Sex.||Scores on a scale||Standard Error|Least Squares Mean
676093|NCT01630135|Secondary|Mean Percent Change From Baseline (BL) in the TOSS for the Baseline TOSS >0 Over the Entire Treatment Period, at Week 1, and at Week 2|Symptoms of eye itching, tearing, and redness were scored by the participant's (par.) parent/guardian who signed the ICF or the par. themself using a scale of 0, 1, 2, or 3 (a larger score indicates more severe symptoms) and were recorded in the par.'s diary. The TOSS is the sum of all 3 symptom scores and ranges from 0 to 9. The mean of the BL period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (Weeks 1 and 2), Week 1, and Week 2. For each assessment period, a mean score for each par. was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Percent change from BL=(mean score at post-BL assessment minus score at BL) divided by the BL value * 100.|Baseline through the entire treatment period (2 weeks), Week 1, and Week 2|FAS. Only those participants with BL TOSS >0 who were available for assessment at both BL and the indicated assessment period were analyzed. Participants were analyzed for the entire treatment period if they had an assessment on any day during Week 1 and Week 2. Analysis was based on an ANCOVA with a model adjusting for Treatment, BL, Age, and Sex.||Percent change||Standard Error|Least Squares Mean
676094|NCT01630135|Secondary|Mean Percent Change From Baseline (BL) in the TOSS Over the Entire Treatment Period, at Week 1, and at Week 2|Symptoms of eye itching, tearing, and redness were scored by the participant's (par.) parent/guardian who signed the ICF or the par. themself using a scale of 0, 1, 2, or 3 (a larger score indicates more severe symptoms) and were recorded in the par.'s diary. The TOSS is the sum of all 3 symptom scores and ranges from 0 to 9. The mean of the BL period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (Weeks 1 and 2), Week 1, and Week 2. For each assessment period, a mean score for each par. was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Percent change from BL=(mean score at post-BL assessment minus score at BL) divided by the BL value * 100. Par. with a BL TOSS of 0 were not analyzed because percent change from BL could not be calculated.|Baseline through the entire treatment period (2 weeks), Week 1, and Week 2|FAS. Only those participants who were available for assessment at both Baseline and the indicated assessment period were analyzed. Participants were analyzed for the entire treatment period if they had an assessment on any day during Week 1 and Week 2. The analysis was based on an ANCOVA with a model adjusting for Treatment, Baseline, Age, and Sex.||Percent change||Standard Error|Least Squares Mean
676109|NCT01629797|Secondary|Number of Correct Responses to Questionnaire Items Before and 2 Months After an Educational Lecture|In order to evaluate the long-term effect of an educational lecture about acne, subjects completed a questionnaire to assess knowledge about acne immediately before and two months after the educational lecture. The number of correct responses to each questionnaire item was calculated pre- and two months post-educational lecture.|before and 2 months after an educational lecture|||participants|||Number
676372|NCT01625507|Secondary|Program Retention|attendance at meetings|3 months|||Participants|||Count of Participants
676373|NCT01625507|Secondary|Change in Hemoglobin A1c|a surrogate of blood glucose control|4 months|||percentage of hemoglobin A1c||95% Confidence Interval|Mean
676095|NCT01630135|Secondary|Mean Change From Baseline (BL) in the Total Ocular Symptom Score (TOSS) for the Baseline TOSS >0 Over the Entire Treatment Period, at Week 1, and at Week 2|Symptoms of eye itching, tearing, and redness were scored by the participant's parent/guardian who signed the ICF or the participant themself using a scale of 0, 1, 2, or 3 (a larger score indicates more severe symptoms) and were recorded in the participant's diary. The TOSS is the sum of all three symtpom scores and ranges from 0 to 9. The mean of the Baseline period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (Weeks 1 and 2), Week 1, and Week 2. For each assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline through the entire treatment period (2 weeks), Week 1, and Week 2|FAS. Only those participants with BL TOSS >0 who were available for assessment at both BL and the indicated assessment period were analyzed. Participants were analyzed for the entire treatment period if they had an assessment on any day during Week 1 and Week 2. Analysis was based on an ANCOVA with a model adjusting for Treatment, BL, Age, and Sex.||Scores on a scale||Standard Error|Least Squares Mean
676096|NCT01630135|Secondary|Mean Change From Baseline in the Total Ocular Symptom Score (TOSS) Over the Entire Treatment Period, at Week 1, and at Week 2|Symptoms of eye itching, tearing, and redness were scored by the participant's parent/guardian who signed the ICF or the participant themself using a scale of 0, 1, 2, or 3 (a larger score indicates more severe symptoms) and were recorded in the participant's diary. The TOSS is the sum of all three symtpom scores and ranges from 0 to 9. The mean of the Baseline period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (Weeks 1 and 2), Week 1, and Week 2. For each assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline through the entire treatment period (2 weeks), Week 1, and Week 2|FAS. Only those participants who were available for assessment at both Baseline and the indicated assessment period were analyzed. Participants were analyzed for the entire treatment period if they had an assessment on any day during Week 1 and Week 2. The analysis was based on an ANCOVA with a model adjusting for Treatment, Baseline, Age, and Sex.||Scores on a scale||Standard Error|Least Squares Mean
676097|NCT01630135|Secondary|Mean Change From Baseline in Rhinorrhea, Nasal Congestion, Sneezing, and Nasal Itching Over the Entire Treatment Period (ETP), at Week 1, and at Week 2|Four individual symptoms (sneezing, rhinorrhea, nasal congestion, and nasal itching) were scored on a scale from 0 to 3 using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average of the symptom scores in the last 4 consecutive days prior to Visit 2 (start of the treatment period). A mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline through the entire treatment period (2 weeks), Week 1, and Week 2|FAS. Only those participants who were available for assessment at both Baseline and the indicated assessment period were analyzed. Participants were analyzed for the entire treatment period if they had an assessment on any day during Week 1 and Week 2. The analysis was based on an ANCOVA with a model adjusting for Treatment, Baseline, Age, and Sex.||Scores on a scale||Standard Error|Least Squares Mean
676098|NCT01630135|Secondary|Mean Percent Change From Baseline in the 4TNSS Over the Entire Treatment Period, at Week 1, and at Week 2|The 4TNSS is the sum of the 4 individual symptom scores for sneezing, rhinorrhea, nasal congestion, and nasal itching. Each symptom is scored on a scale from 0 to 3; the range of sums for the 4TNSS is 0 to 12. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average 4TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). For the entire treatment period (Weeks 1 and 2), Week 1, and Week 2, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Percent change from Baseline=(mean score at the post-Baseline assessment minus the score at Baseline) divided by the Baseline value * 100.|Baseline through the entire treatment period (2 weeks), Week 1, and Week 2|FAS. Only those participants who were available for assessment at both Baseline and the indicated assessment period were analyzed. Participants were analyzed for the entire treatment period if they had an assessment on any day during Week 1 and Week 2. The analysis was based on an ANCOVA with a model adjusting for Treatment, Baseline, Age, and Sex.||Percent change||Standard Error|Least Squares Mean
676099|NCT01630135|Secondary|Mean Change From Baseline in the 4 Total Nasal Symptom Score (4TNSS) Over the Entire Treatment Period, at Week 1, and at Week 2|The 4TNSS is the sum of the 4 individual symptom scores for sneezing, rhinorrhea, nasal congestion, and nasal itching. Each symptom is scored on a scale from 0 to 3; the range of sums for the 4TNSS is 0 to 12. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average of the 4TNSS in the last 4 consecutive days prior to Visit 2 (start of the treatment period). A mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline through the entire treatment period (2 weeks), Week 1, and Week 2|FAS. Only those participants who were available for assessment at both Baseline and the indicated assessment period were analyzed. Participants were analyzed for the entire treatment period if they had an assessment on any day during Week 1 and Week 2. The analysis was based on an ANCOVA with a model adjusting for Treatment, Baseline, Age, and Sex.||Scores on a scale||Standard Error|Least Squares Mean
676374|NCT01625507|Primary|Change in Nutrient Intake|Measured using repeated 24 hour dietary recalls (pre and post-intervention)|3 months|||grams||95% Confidence Interval|Mean
676100|NCT01630135|Secondary|Mean Change From Baseline in 3TNSS at the Indicated Days|The 3TNSS is the sum of the 3 individual symptom scores for sneezing, rhinorrhea, and nasal congestion. Each symptom is scored on a scale from 0 to 3; the range of sums for the 3TNSS is 0 to 9. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average 3TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). Change from Baseline was calculated as the mean score at the indicated day minus the score at Baseline.|Baseline; Days 1 through 14|FAS. Change from Baseline was analyzed for only those participants who were available for assessment at both Baseline and the indicated study day (Days 1 through 14). The analysis was based on an ANCOVA with a model adjusting for Treatment, Baseline, Age, and Sex.||Scores on a scale||Standard Error|Least Squares Mean
676101|NCT01630135|Secondary|Mean Percent Change From Baseline in 3TNSS Over the Entire Treatment Period, at Week 1, and at Week 2|The 3TNSS is the sum of the 3 individual symptom scores for sneezing, rhinorrhea, and nasal congestion. Each symptom is scored on a scale from 0 to 3; the range of sums for the 3TNSS is 0 to 9. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average 3TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). For the entire treatment period (Weeks 1 and 2), Week 1, and Week 2, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Percent change from Baseline=(mean score at the post-Baseline assessment minus the score at Baseline) divided by the Baseline value * 100.|Baseline through the entire treatment period (2 weeks), Week 1, and Week 2|FAS. Only those participants who were available for assessment at both Baseline and the indicated assessment period were analyzed. Participants were analyzed for the entire treatment period if they had an assessment on any day during Week 1 and Week 2. The analysis was based on an ANCOVA with a model adjusting for Treatment, Baseline, Age, and Sex.||Percent change||Standard Error|Least Squares Mean
676102|NCT01630135|Secondary|Mean Change From Baseline in 3TNSS at Week 1 and Week 2|The 3TNSS is the sum of the 3 individual symptom scores for sneezing, rhinorrhea, and nasal congestion. Each symptom is scored on a scale from 0 to 3; the range of sums for the 3TNSS is 0 to 9. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average 3TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). For Week 1 and Week 2, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the mean score at Week 1 and Week 2 minus the score at Baseline.|Baseline; Week 1 and Week 2|FAS. Change from Baseline was analyzed for only those participants who were available for assessment at both Baseline and the indicated assessment period. The analysis was based on ANCOVA with a model adjusting for Treatment, Baseline, Age, and Sex.||Scores on a scale||Standard Error|Least Squares Mean
676103|NCT01630135|Primary|Mean Change From Baseline in the 3 Total Nasal Symptom Score (3TNSS) Over the Entire Treatment Period|The 3TNSS is the sum of the 3 individual symptom scores for sneezing, rhinorrhea, and nasal congestion. Each symptom is scored on a scale from 0 to 3; the range of sums for the 3TNSS is 0 to 9. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the informed consent form (ICF) or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average 3TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). For the entire assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the mean score for the entire treatment period minus the score at Baseline.|Baseline through the entire treatment period (2 weeks)|Full Analysis Set (FAS): all participants meeting the primary criteria for enrollment, without any major good clinical practice (GCP) deviation, who received at least one dose of the assigned treatment and had diary assessment for 3TNSS after receiving a dose of study medication||Scores on a scale||Standard Error|Least Squares Mean
676104|NCT01630109|Secondary|Difference in Pill Capsule Completion Rates in Diabetics vs. Non-diabetics|This study will investigate whether there is any difference in pill capsule completion rates in patients who are diabetic vs. those who are not diabetic.|12 hours|||Percentage of complete studies|||Number
676105|NCT01630109|Secondary|Differences in Small Bowel Transit Time in Treatment vs. Placebo in Pill Capsule Studies|This study will investigate whether there is a difference in small bowel transit time in pill capsule studies with treatment with metoclopramide (5 mg or 10 mg) vs. placebo.|12 hours|||minutes||Standard Deviation|Mean
676106|NCT01630109|Secondary|Differences in Gastric Transit Time in Treatment vs. Placebo in Pill Capsule Studies|This study will investigate whether treatment with metoclopramide (5 mg or 10 mg) vs. placebo will affect gastric transit time.|12 hours|||minutes||Standard Deviation|Mean
676107|NCT01630109|Primary|Difference in Treatment vs. Placebo in Pill Capsule Completion Rates|This study is investigating whether there is a difference in pill capsule completion rates between a treatment group (metoclopramide) vs. placebo. It is also looking at differences in completion rates between two different doses of metoclopramide (5 mg vs. 10 mg).|12 hours|||percentage of complete capsule studies|||Number
676108|NCT01629823|Primary|Methacholine Reactivity|The primary outcome measure was the change in provocative concentration of methacholine causing a 20% fall in forced expiratory volume in 1 second (FEV₁) (PC20) from baseline to 12 weeks. Modified American Thoracic Society guidelines were followed for pre-bronchodilator spirometry and methacholine challenge testing using the 5 breath dosimeter technique. Up to eleven doses, each a doubling concentration of methacholine (Provocholine™), were inhaled starting at 0.03 mg/mL until a 20% or greater fall in FEV₁ occurred; the maximum dose was 32 mg/mL. Breaths each of doubling concentrations of methacholine were inhaled from a calibrated DeVilbiss™ 646 nebulizer.|12 weeks after randomization|||mg/mL||95% Confidence Interval|Geometric Mean
676111|NCT01629784|Secondary|Percentage of Subjects Who Correctly Answered a Knowledge or Behavioral Assessment Item Before and 3 Months After an Educational Lecture|In order to evaluate the long-term effect of an educational lecture about cutaneous lupus erythematosus (CLE) and sun protection, subjects completed a questionnaire to assess knowledge about CLE and sun protection behaviors immediately before and three months after an educational lecture. The percentage of subjects who correctly answered a knowledge or behavioral assessment item were calculated pre- and three months post-educational lecture.|before and 3 months after an educational lecture|||percentage of participants|||Number
676112|NCT01629784|Primary|Percentage of Subjects Who Correctly Answered a Knowledge Assessment Item Immediately Before and After an Educational Lecture|In order to evaluate the immediate effect of an educational lecture about cutaneous lupus erythematosus (CLE) and sun protection, subjects completed a written questionnaire to assess knowledge about CLE and sun protection immediately before and after the educational lecture. The percentage of subjects who correctly answered a knowledge assessment item were calculated pre- and post-educational lecture.|immediately before and after an educational lecture|||percentage of participants|||Number
676113|NCT01629771|Primary|World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) Domain Scores|The WHODAS 2.0 is a generic health and disability assessment tool that describes effects of disease on six domains: Cognition, Mobility, Self-Care, Getting Along, Life Activities, and Participation in Society. Responses are measured on a 5-point scale from 1 (no difficulty) to 5 (extreme difficulty or cannot do). Scores are calculated using a WHO SPSS 36 version syntax for employed subjects and a WHO SPSS 32 version syntax for unemployed subjects. Scores for each domain range from 0 to 100, where 0 is associated with no impairment of health status, and 100 is associated with a greater impairment of health status.|Assessed after enrollment|||units on a scale||Inter-Quartile Range|Median
676114|NCT01629771|Primary|Lymphatic Filariasis-Specific Quality of Life (LFSQQ) Domain Scores|The LFSQQ was developed to assess quality of life in subjects with lymphatic filariasis through seven domains: Mobility, Self-Care, Usual Activities, Disease Burden, Pain/Discomfort, Psychological Health, and Social Participation. Items are scored on a 5-point scale (no problem, mild, moderate, severe, most severe), and scores for each domain are calculated based on the number of questions answered and the raw scores. Scores for each domain range from 0 to 100, where 0 is associated with a worse quality of life and 100 is associated with a better quality of life.|Assessed after enrollment|||units on a scale||Inter-Quartile Range|Median
676115|NCT01629771|Primary|Dermatology Life Quality Index (DLQI) Domain Scores|The DLQI is a 10-item questionnaire measuring skin-specific quality of life through six domains: Symptoms & Feelings, Daily Activities, Leisure, Work & School, Personal Relationships, and Treatment. Symptoms & Feelings, Daily Activities, Leisure, and Personal Relationships are each scored from 0 to 3, where 0 is associated with no effect on a patient's life, and 3 is associated with a large effect on a patient's life. Work & School and Treatment are each scored from 0 to 3, where 0 is associated with no effect on a patient's life, and 6 is associated with a large effect on a patient's life.|Assessed after enrollment|||units on a scale||Inter-Quartile Range|Median
676116|NCT01629706|Primary|Ratio of Viable and Non-Viable Epithelial Cells at Day 1 and Week 4, Phase 2|The worn contact lenses were removed, rinsed and transferred in individual glass vials. Epithelial cells were collected directly from the ocular surface using an eyewash. Samples were taken to a laboratory and incubated with live/dead stains. Cells collected from the right and the left eye were combined; cells collected from the right and the left lens were combined. The number of viable and non-viable cells was counted using a microscope. The ratio between viable and non-viable cell counts was calculated. A higher number indicates a higher percentage of non-viable cells relative to the total cell count.|Day 1 and Week 4|This reporting group included all participants that completed Phase 2 of the study with expected in-range responses.||percentage of cells||Standard Deviation|Mean
676117|NCT01629706|Primary|Ratio of Epithelial Cells Collected Directly From the Ocular Surface and Cells Collected From the Contact Lens at Day 1 and Week 4, Phase 2|The worn contact lenses were removed, rinsed and transferred in individual glass vials. Epithelial cells were collected directly from the ocular surface using an eyewash. Samples were taken to a laboratory and cells collected from the right and the left eye were combined; cells collected from the right and the left lens were combined. The ratio of cells collected from the ocular surface and from the contact lens was calculated. A higher number indicates a higher percentage of cells collected from the contact lenses relative to the total number of cells collected.|Day 1 and Week 4|This reporting group included all participants that completed Phase 2 of the study with expected in-range responses.||percentage of cells||Standard Deviation|Mean
676118|NCT01629706|Primary|Mean Number of Epithelial Cells Collected Directly From the Ocular Surface at Day 1 and Week 4, Phase 2|The worn contact lenses were removed and epithelial cells were collected directly from the ocular surface using an eyewash. Immediately following the eyewash, samples were taken to a laboratory and incubated with live/dead stains. The number of cells (viable and non-viable) was counted using a microscope. Cells collected from right and left eyes were pooled. Samples were collected after 8 hours of wear. A significant difference in cell count may indicate a physiological response to contact lens wear due to lens age.|Day 1 and Week 4|This reporting group included all participants that completed Phase 2 of the study with expected in-range responses.||cells||Standard Deviation|Mean
676119|NCT01629706|Primary|Mean Number of Epithelial Cells Collected From the Contact Lens at Day 1 and Week 4, Phase 2|The worn contact lenses were removed and transferred into well plates, each containing a soaking solution. Following a soaking duration of approximately 30 minutes, lenses were rinsed and transferred in individual glass vials. The cell content from the lens wash was taken to a laboratory and incubated with live/dead stains. The total number of cells (viable and non-viable) were counted using a microscope. Cells collected from right and left lens were pooled. Samples were collected after 8 hours of wear. A significant difference in cell count may indicate a physiological response to contact lens wear due to lens age.|Day 1 and Week 4|This reporting group included all participants that completed Phase 2 of the study with expected in-range responses.||cells||Standard Deviation|Mean
676159|NCT01629589|Primary|Number of Participants With Antibody Responses to Tetanus and Diphtheria Components Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine|Tetanus antibody was assayed by Enzyme-linked immunosorbent assay (ELISA) and Diphtheria antibody by a toxin neutralization test. Antibody responses to tetanus and diphtheria components were defined as titers ≥0.1 IU/mL and ≥1.0 IU/mL|Day 0 (pre-vaccination) to Day 28 (post-vaccination)|The antibody responses to tetanus and diphtheria components were determined in the Per-Protocol Analysis Set.||Participants|||Number
676120|NCT01629706|Primary|Mean Number of Non-Viable Epithelial Cells Collected Directly From the Ocular Surface at Day 1 and Week 4, Phase 2|The worn contact lenses were removed and epithelial cells were collected directly from the ocular surface using an eyewash. Immediately following the eyewash, samples were taken to a laboratory and incubated with live/dead stains. The number of non-viable cells was counted using a microscope. Cells collected from right and left eyes were pooled.Samples were collected after 8 hours of wear. A significant difference in cell count may indicate a physiological response to contact lens wear due to lens age|Day 1 and Week 4|This reporting group included all participants that completed Phase 2 of the study with expected in-range responses.||cells||Standard Deviation|Mean
676121|NCT01629706|Primary|Mean Number of Viable Epithelial Cells Collected Directly From the Ocular Surface at Day 1 and Week 4, Phase 2|The worn contact lenses were removed and epithelial cells were collected directly from the ocular surface using an eyewash. Immediately following the eyewash, samples were taken to a laboratory and incubated with live/dead stains. The number of viable cells was counted using a microscope. Cells collected from right and left eyes were pooled. Samples were collected after 8 hours of wear. A significant difference in cell count may indicate a physiological response to contact lens wear due to lens age.|Day 1 and Week 4|This reporting group included all participants that completed Phase 2 of the study with expected in-range responses.||cells||Standard Deviation|Mean
676122|NCT01629706|Primary|Ratio of Viable and Non-Viable Epithelial Cells After 2 Hours and 4 Hours of Wear, Phase 1|"The worn contact lenses were removed, rinsed and transferred in individual glass vials. Epithelial cells were collected directly from the ocular surface using an eyewash. Samples were taken to a laboratory and incubated with live/dead stains. Cells collected from each lens and each eye were counted separately using a microscope. The number of viable and non-viable cells was counted using a microscope. The ratio between viable and non-viable cell counts was calculated.
A higher number indicates a higher percentage of non-viable cells relative to the total cell count."|Day 1 after 2 hours of wear; Day 7 after 4 hours of wear|This reporting group included all participants that completed Phase 1 of the study with expected in-range responses.||percentage of cells||Standard Deviation|Mean
676123|NCT01629706|Primary|Ratio of Epithelial Cells Collected Directly From the Ocular Surface and Cells Collected From the Contact Lens After 2 Hours and 4 Hours of Wear, Phase 1|The worn contact lenses were removed, rinsed and transferred in individual glass vials. Epithelial cells were collected directly from the ocular surface using an eyewash. Samples were taken to a laboratory and cells collected from each lens and each eye were counted separately using a microscope. The ratio of cells collected from the ocular surface and from the contact lens was calculated. A higher number indicates a higher percentage of cells collected from the contact lenses relative to the total number of cells collected.|Day 1 after 2 hours of wear; Day 7 after 4 hours of wear|This reporting group included all participants that completed Phase 1 of the study with expected in-range responses.||percentage of cells||Standard Deviation|Mean
676124|NCT01629706|Primary|Mean Number of Fluorescein-Stained Epithelial Cells Collected Directly From the Ocular Surface After 2 Hours and 4 Hours of Wear, Phase 1|The worn contact lenses were removed and epithelial cells were collected directly from the ocular surface using an eyewash. Immediately following the eyewash, samples were taken to a laboratory. The total number of fluorescein-stained cells was counted using a microscope. Cells collected from the right and the left eye were analyzed separately. A significant difference in fluorescein-stained cell count may indicate a physiological response to the contact lens and/or care regimen over time.|Day 1 after 2 hours of wear; Day 7 after 4 hours of wear|This reporting group included all participants that completed Phase 1 of the study with expected in-range responses.||cells||Standard Deviation|Mean
676125|NCT01629706|Primary|Mean Number of Non-Viable Epithelial Cells Collected Directly From the Ocular Surface After 2 Hours and 4 Hours of Wear, Phase 1|The worn contact lenses were removed and epithelial cells were collected directly from the ocular surface using an eyewash. Immediately following the eyewash, samples were taken to a laboratory and incubated with live/dead stains. The number of non-viable (dead) cells was counted using a microscope. Cells collected from the right and the left eye were analyzed separately. A significant difference in non-viable cell count may indicate a physiological response to the contact lens and/or care regimen over time.|Day 1 after 2 hours of wear; Day 7 after 4 hours of wear|This reporting group included all participants that completed Phase 1 of the study with expected in-range responses.||cells||Standard Deviation|Mean
676126|NCT01629706|Primary|Mean Number of Viable Epithelial Cells Collected Directly From the Ocular Surface After 2 Hours and 4 Hours of Wear, Phase 1|The worn contact lenses were removed and epithelial (corneal) cells were collected directly from the ocular surface using an eyewash. Immediately following the eyewash, samples were taken to a laboratory and incubated with live/ dead stains. The number of viable (alive) cells was counted using a microscope. Cells collected from the right and the left eye were analyzed separately. A significant difference in viable cell count may indicate a physiological response to the contact lens and/or care regimen over time.|Day 1 after 2 hours of wear; Day 7 after 4 hours of wear|This reporting group included all participants that completed Phase 1 of the study with expected in-range responses.||cells||Standard Deviation|Mean
676127|NCT01629693|Primary|"Change From Baseline in Likert Response: I Can Comfortably Wear my Lenses at Day 30"|Overall comfort was assessed by the participant as a response to the questionnaire item 'I can comfortably wear my lenses', using a 10-point Likert scale, with 1=poor and 10=excellent.|Baseline, Day 30|This analysis population includes all participants who completed the protocol and had no major protocol violations.||units on a scale||Standard Deviation|Mean
676128|NCT01629667|Secondary|Percentage of Participants Positive for Anti-Drug Antibodies to Tralokinumab|A participant was considered ADA-positive across the study if they had a positive reading at any time point during the study.|From the start of study treatment through Week 88|"The safety population included all participants who received any study investigational product and participants were analysed according to the treatment they actually received. Here, n is number of participants analysed at given time point."||Percentage of participant|||Number
676129|NCT01629667|Secondary|Mean Serum Concentration of Tralokinumab|The mean serum concentration of Tralokinumab were observed.|Predose, 0 hour, and 2 hour postdose on Week 0; predose on Week 4, 48, 72, 82 and 88|"The Pharmacokinetic population included all participants who received at least one dose of tralokinumab and had at least one detectable trough (Weeks 4, 48 or 72 only) serum concentration measurement. Here, n is number of participants analysed at given time point."||microgram per milliliter (mcg/ml)||Standard Deviation|Mean
676130|NCT01629667|Secondary|Number of Participants With Patient Global Impression of Change (PGI-C) for Idiopathic Pulmonary Fibrosis (IPF)|The PGI-C is a single-item, global assessment designed to capture participant-perceived change in their IPF health condition using a 7-point scale (-3 = very much improved, 0 = no change, about the same, 3 = very much worse).|Week 72|"The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, N is number of participants analysed for this outcome measure."||Participant|||Number
676131|NCT01629667|Secondary|Number of Participants With Patient Global Impression of Severity (PGI-S) for Idiopathic Pulmonary Fibrosis (IPF)|The PGI-S is a single-item, global assessment of participant-perceived IPF severity. The assessment was designed to capture participant perceived IPF-related health status. Participants rate their IPF severity using a 5-point scale (1 = very mild, 5 = very severe).|Week 72|"The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, N is number of participants analysed for this outcome measure."||Participant|||Number
676132|NCT01629667|Secondary|Change From Baseline in European Quality of Life-5-Dimension 3 Level Version (EQ-5D-3L) (Including Visual Analog Scale [VAS]) at Week 72|The EQ-5D-3L is a standardized PRO used to capture respondent’s general health status. The questionnaire assesses 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 response options (no problem, some or moderate problems, and unable or extreme problems) that reflect increasing levels of difficulty. The questionnaire also includes a visual analog scale, where the participants were asked to rate their current health on a scale of 0-100, with 0 being the worst imaginable health state.|Baseline and Week 72|"The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, n is number of participants analysed at given time point."||Units on a scale||Standard Deviation|Mean
676133|NCT01629667|Secondary|Change From Baseline in Exacerbations of Chronic Pulmonary Disease (EXACT IPF) Total Score Through Week 72|The EXACT-IPF is a 14-item daily dairy used to capture the IPF related symptoms completed by the participants using an eDiary. The EXACT-IPF total score is the sum of all items ranged from 1 to 14. EXACT-IPF is an interval-level scale ranging from 0 to 100, where the higher scores indicate more severe condition. The EXACT-IPF used Likert scales (with 3 to 6 response options each) to capture participant reported IPF-related symptoms. The scores are the simple sum of item responses for each domain or single item.|Baseline, Week 52 and 72|"The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, n is number of participants analysed at given time point."||Units on a scale||Standard Deviation|Mean
676134|NCT01629667|Secondary|Change From Baseline in St. George’s Respiratory Questionnaire (SGRQ) Total Score at Week 72|The SGRQ is a 50-item Patient-reported outcome (PRO) instrument developed to measure respiratory-related health status via 76 weighted responses. The SGRQ is divided into two parts. Part 1 asks respondents to consider the last 3 months and report on their respiratory symptoms using 5-point Likert scales. Part 2 asks respondents to consider their current state and respond to a series of dichotomous yes/no items related to their activities (activities that cause or were limited by breathlessness) and impacts (social functioning, psychological disturbances resulting from airways disease). Total scores and domain scores (symptoms, activities, and impact on daily life) were scored from 0-100, where lower scores indicate better health status.|Baseline and Week 72|"The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, n is number of participants analysed at given time point."||Units on a scale||Standard Deviation|Mean
676135|NCT01629667|Secondary|Change From Baseline in University of California San Diego Shortness of Breath Questionnaire (UCSD SOBQ) Total Score at Week 72|The UCSD SOBQ is a 24-item questionnaire designed to capture patient-reported shortness of breath. Respondents were asked to rate their breathlessness during 21 activities of daily living using a 6-point scale (0 = not at all breathless, 5 = maximally breathless or too breathless to do this activity). In addition to the 21 activity items, the UCSD SOBQ includes 3 additional questions about limitations due to shortness of breath, fear of harm from overexertion, and fear of shortness of breath. The UCSD SOBQ was scored by summing responses across all 24 items to form a total score. Scores range from 0-120 with higher scores indicative of greater shortness of breath.|Baseline and Week 72|"The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, n is number of participants analysed at given time point."||Units on a scale||Standard Deviation|Mean
676136|NCT01629667|Secondary|Number of Participants With Clinical Global Impression of Change Scores|The CGI-C is a single, clinician completed, item designed to capture the clinicians overall impression of change in IPF severity from the baseline state at Screening. Clinicians were asked to rate the participants IPF severity relative to their state at baseline using a 7-point scale (-3 = very much worse, 0 = no change, about the same, 3 = very much improved).|Week 72|"The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, N is number of participants analysed for this outcome measure."||Participant|||Number
676137|NCT01629667|Secondary|Number of Participants With Clinical Global Impression of Severity Scores|The CGI-S is a single, clinician completed, item designed to capture the clinician’s impression of the participants IPF severity. Clinicians were asked to consider their experience in this participant population and rate the overall IPF severity of the participant using a 5-point scale (1 = very mild, 5 = very severe).|Week 72|"The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, N is number of participants analysed for this outcome measure."||Participant|||Number
676138|NCT01629667|Secondary|Change From Baseline in Absolute Forced Vital Capacity (FVC) Through Week 72|Forced vital capacity (FVC) is a standard pulmonary function test used to monitor disease progression in IPF. FVC was the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in litres.|Baseline, Week 52 and 72|"The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, n is number of participants analysed at given time point."||Liter||Standard Deviation|Mean
676139|NCT01629667|Secondary|Change From Baseline in Percent-predicted FEV1 Through Week 72|FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Predicted FEV1 is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FEV1 = (observed value)/(predicted value) * 100%.|Baseline, Week 52 and 72|"The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, n is number of participants analysed at given time point."||Percent of predicted FEV1||Standard Deviation|Mean
676140|NCT01629667|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Through Week 72|FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration.|Baseline, Week 52 and 72|"The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, n is number of participants analysed at given time point."||Liter||Standard Deviation|Mean
676141|NCT01629667|Secondary|Percentage of Participants With Adjudicated Hospitalization|Participants who were hospitalized due to IPF exacerbation were observed. All events that resulted in the hospitalization of participants were adjudicated by an independent committee to determine if the event was due to an IPF exacerbation as follows: 1. Exacerbation or progression of IPF, 2. Result of a complication of IPF, 3. Not related to IPF (alternative diagnosis provided), and 4. Undetermined due to insufficient information.|Week 52 and 72|The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization.||Percentage of participant|||Number
676142|NCT01629667|Secondary|Percentage of Participants With Adjudicated Mortality|Participants all cause mortality were observed. Events that resulted in participant death were adjudicated into respiratory-related mortality or all other cause mortality by an independent committee.|Week 52 and 72|The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization.||Percentage of participant|||Number
676143|NCT01629667|Secondary|Percentage of Participants With Idiopathic Pulmonary Fibrosis (IPF) Exacerbations|"The IPF exacerbations is defined as an acute, clinically significant, deterioration of unidentifiable cause in a participant with underlying IPF. Exacerbations of IPF were adjudicated according to the protocol definition by an independent committee as follows:
1. Confirmed acute IPF exacerbation, 2. Suspected acute IPF exacerbation, 3. Not an IPF exacerbation with an alternative diagnosis provided if possible, and 4. Undetermined due to insufficient information."|Week 52 and 72|The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization.||Percentage of participant|||Number
676144|NCT01629667|Secondary|Change From Baseline in Lung Volumes Through Week 72|Lung volumes were evaluated by total lung capacity (TLC), residual volume (RV), and vital capacity (VC). Lung volumes were determined by body plethysmography.|Baseline, Week 52 and 72|"The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, n is number of participants analysed at given time point."||Liter||Standard Deviation|Mean
676145|NCT01629667|Secondary|Change From Baseline in Oxygen Saturation by Pulse Oximetry at Week 68|Participants transcutaneous oxygen saturation were observed by pulse oximetry.|Baseline and Week 68|"The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, n is number of participants analysed at given time point."||Percent of oxygen saturation||Standard Deviation|Mean
676146|NCT01629667|Secondary|Change From Baseline in 6 Minute Walk Test (6MWT) Distance Through Week 72|The 6MWT measures the distance that a participant can walk on a measured, flat hard surface in a period of 6 minutes. The 6MWT evaluates the global and integrated responses of all body systems involved during walking.|Baseline, Week 52 and 72|"The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, n is number of participants analysed at given time point."||Meter||Standard Deviation|Mean
676147|NCT01629667|Secondary|Change From Baseline in Haemoglobin (Hb) Corrected Percent-predicted Diffusion Capacity for Carbon Monoxide (DLco) Through Week 72|The single breath technique was used to determine the DLco. The test was performed by qualified pulmonary function technicians with experience performing this study. Acceptable test criteria included:• An inspiratory volume of more than 85% of vital capacity. • A stable breath hold of 10 seconds (+/- 2 seconds) with no leaks, Valsalva or Mueller maneuvers. • Expiration in less than 4 seconds with appropriate clearance of dead space. The average of the two best acceptable maneuvers was used. There must be a minimum of 4 minutes between the performances of each test.|Baseline, Week 52 and 72|"The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, n is number of participants analysed at given time point."||Percent predicted DLco||Standard Deviation|Mean
676148|NCT01629667|Secondary|Percentage of Participants With Disease Progression|Progression-free Survival (PFS) was used to evaluate disease progression and the percentage of participants with disease progression. A participant was classified as having disease progression if at least one of the following criteria were met:• Adjudicated respiratory-related mortality. •Adjudicated hospitalization due to IPF exacerbation. •Confirmed decline in percent-predicted FVC of greater than or equal to (>=) 10%. •Confirmed decline in 6 minute walk test (6MWT) >= 50 meters.|Week 52 and 72|The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization.||Percentage of Participant|||Number
676149|NCT01629667|Secondary|Number of Participants With Electrocardiogram Abnormalities Reported as Treatment-emergent Adverse Events|AEs observed in participants with clinically significant ECG abnormalities were assessed. Tricuspid valve incompetence was the only abnormality reported as TEAE. ECG parameters included heart rate, PR, QRS, QT, and QTc intervals. Treatment-emergent were events between administration of investigational product and Week 88 that were absent before treatment or that worsened relative to pre-treatment state.|From the start of study treatment through Week 88|The safety population included all participants who received any study investigational product and participants were analysed according to the treatment they actually received.||Participant|||Number
676150|NCT01629667|Secondary|Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events|Vital signs parameters included heart rate, blood pressure, temperature, weight, pulse oximetry and respiratory rate. Treatment-emergent were events between administration of investigational product and Week 88 that were absent before treatment or that worsened relative to pre-treatment state.|From the start of study treatment through Week 88|The safety population included all participants who received any study investigational product and participants were analysed according to the treatment they actually received.||Participant|||Number
676151|NCT01629667|Secondary|Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events|An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Treatment-emergent were events between administration of investigational product and Week 88 that were absent before treatment or that worsened relative to pre-treatment state. Laboratory evaluations (haematology, serum chemistry and urinalysis) of blood and urine samples were performed.|From the start of study treatment through Week 88|The safety population included all participants who received any study investigational product and participants were analysed according to the treatment they actually received.||Participant|||Number
676152|NCT01629667|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)|Any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening situation (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received Tralokinumab. Treatment-emergent were events between administration of investigational product and Week 88 that were absent before treatment or that worsened relative to pretreatment state.|From the start of study treatment through Week 88|The safety population included all participants who received any study investigational product and participants were analysed according to the treatment they actually received.||Participant|||Number
676153|NCT01629667|Primary|Change From Baseline in Percent-predicted Forced Vital Capacity (FVC) at Week 52|Forced vital capacity (FVC) is a standard pulmonary function test used to monitor disease progression in IPF. FVC was the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in litres. Predicted forced vital capacity is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FVC = (observed value)/(predicted value) * 100%.|Baseline and Week 52|"The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, n is number of participants analysed at given time point."||Percentage of predicted FVC||Standard Deviation|Mean
676154|NCT01629589|Secondary|Number of Participants Reporting Immediate Unsolicited Adverse Events Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine|The occurrence, nature (Medical Dictionary for Regulatory Activities (MedDRA) preferred term), duration, intensity, and relationship to vaccination of adverse events (AEs) reported in the 15 minutes after vaccination and systemic AEs.|Up to 15 minutes post-vaccination|Number of participants reporting immediate unsolicited adverse events was determined in all participants in the Safety Analysis Set.||Participants|||Number
676155|NCT01629589|Secondary|Number of Participants With Booster Responses Against the Pertussis Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine|"Adacel booster response defined as: a 4-fold increase in pre- to post-vaccination antibody concentrations for subjects with a pre vaccination concentration ≤93 ELISA Unit (EU)/mL for Pertussis toxoid (PT), ≤170 EU/mL for Filamentous hemagglutinin (FHA), ≤115 EU mL for pertactin (PRN), or ≤285 EU/mL for Fimbriae types 2 and 3 (FIM), and defined as a 2-fold increase for subjects with a pre-vaccination concentration >93 EU/mL for PT, >170 EU/mL for FHA, >115 EU/mL for PRN, or >285 EU/mL for FIM.
Boostrix booster response defined as: a post-vaccination titer ≥4 times the LLOQ for subjects with a pre-vaccination titer <LLOQ, a post-vaccination titer ≥4 times the pre-vaccination titer for subjects with a pre-vaccination titer between LLOQ and 4x LLOQ, or a post-vaccination titer at least twice the pre-vaccination titer for subjects with a pre-vaccination titer ≥4x LLOQ."|Day 28 post-vaccination|Booster response against Pertussis antibodies were determined in the Per-Protocol Analysis Set.||Participants|||Number
676156|NCT01629589|Secondary|Geometric Mean Concentrations of the Pertussis Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine|Pertussis antibodies Pertussis toxoid (PT), Filamentous hemagglutinin (FHA), Pertactin (PRN), and Fimbriae types 2 and 3 (FIM 2&3) were assayed by Enzyme-linked immunosorbent assay (ELISA)|Day 0 (pre-vaccination) to Day 28 post-vaccination|Geometric mean concentrations of the Pertussis antibodies were determined in the Per-Protocol Analysis Set.||Titers||95% Confidence Interval|Geometric Mean
676157|NCT01629589|Secondary|Number of Participants With Booster Responses Against Tetanus and Diphtheria Antigens Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine|"Adacel booster response defined as: a 4-fold increase in pre- to post-vaccination antibody concentrations for subjects with a pre-vaccination concentration ≤2.56 IU/mL for diphtheria and ≤2.7 IU/mL for tetanus, and defined as a 2-fold increase for subjects with a pre-vaccination concentration >2.56 IU/mL for diphtheria and >2.7 IU/mL for tetanus.
Boostrix booster response defined as: a post-vaccination titer ≥4 times the lower limit of quantitation (LLOQ) for subjects with a pre-vaccination titer < LLOQ, a post-vaccination titer ≥4 times the pre-vaccination titer for subjects with a pre-vaccination titer between LLOQ and 4x LLOQ, or a post-vaccination titer at least twice the pre-vaccination titer for subjects with a pre-vaccination titer ≥4x LLOQ."|Day 28 post-vaccination|Booster response against tetanus and diphtheria components were determined in the Per-Protocol Analysis Set.||Participants|||Number
676158|NCT01629589|Secondary|Geometric Mean Concentrations of Tetanus and Diphtheria Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine|Tetanus antibody was assayed by Enzyme-linked immunosorbent assay (ELISA) and Diphtheria antibody by a toxin neutralization test|Day 0 (pre-vaccination) to Day 28 post-vaccination|The geometric mean concentrations of tetanus and diphtheria antibodies were determined in the Per Protocol Analysis Set.||Titers||95% Confidence Interval|Geometric Mean
676160|NCT01629290|Primary|Fluoride Concentration and Release|Fluoride release as measured by concentration of fluoride available in the oral cavity at different time periods after the application of 5% NaF varnish and placebo as measured in unstimulated human saliva|Baseline, 1 hr, 4 hrs, 6 hrs, 26 hrs and 50 hrs|The 15 participants were each involved in each of the successive treatments with Enamel Pro, Duraphat, Vanish, and Placebo, (the order differed for each participant), and to show the differences between baseline and the different treatment levels, the baselines before each of the treatments is listed here along with the relevant treatment.||ppm||Standard Deviation|Mean
676161|NCT01629134|Secondary|Rating of Injection Discomfort|The level of discomfort during treatment on a scale of 0 (no discomfort) to 10 (extreme discomfort).|15 minutes after injection|All subjects who met the criteria and treatment was initiated||scale score||Standard Deviation|Mean
676162|NCT01629134|Secondary|Comparative Rating With Previous Treatment|Subject rating of lip improvement with VOLBELLA compared with previous lip enhancement treatments as significantly better, somewhat better, no difference, somewhat worse, or significantly worse|15 minutes after injection|All subjects who met the criteria and treatment was initiated||Percentage of subjects|||Number
676163|NCT01629134|Secondary|Return to Social Engagement|Time to return to normal daily activities|4 weeks|All subjects who met the criteria and treatment was initiated||Percentage of subjects|||Number
676164|NCT01629134|Secondary|Need for Massage|Injectors rated whether none/minimal, a little, some, or a lot of massage was required to optimize placement of VOLBELLA|15 minutes after injection|All subjects who met the criteria and treatment was initiated||Percentage of subjects|||Number
676165|NCT01629134|Secondary|Malleability of Product|Injectors rated the malleability on a scale ranging from 0 (Extremely malleable/Not hard to mold) to 10 (Not malleable/Hard to mold)|15 minutes after injection|All subjects who met the criteria and treatment was initiated||Percentage of subjects|||Number
676166|NCT01629134|Secondary|Ease of Injection|Injectors rated the ease of injection on a scale ranging from 0 (Very easy) to 10 (Extremely difficult)|15 minutes after injection|All subjects who met the criteria and treatment was initiated||Percentage of subjects|||Number
676167|NCT01629134|Secondary|Swelling of the Lips|Injector assessment of whether there was none, little, some, moderate, or considerable swelling in subjects’ lips|15 minutes after injection|All subjects who met the criteria and treatment was initiated||Percentage of subjects|||Number
676168|NCT01629134|Secondary|Bruising of the Lips|Injector assessment of whether there was none, little, some, moderate, or considerable bruising in subjects’ lips|15 minutes after injection|All subjects who met the criteria and treatment was initiated||Percentage of subjects|||Number
676169|NCT01629134|Primary|Injector Rating of the Natural Look and Feel of the Lips|Percentage of injectors who rated the look and feel of subjects’ lips as being extremely natural, very natural, slightly natural, and not natural.|4 weeks|All subjects who met the criteria and treatment was initiated||Percentage of subjects|||Number
676170|NCT01629134|Primary|Subject Rating of the Natural Look and Feel of the Lips|Percentage of subjects rating the look and feel of their lips as being extremely natural, very natural, slightly natural, and not natural.|4 weeks|All subjects who met the criteria and treatment was initiated||Percentage of subjects|||Number
676171|NCT01628965|Primary|Skin Irritation Score of the Application Site|"Skin irritation score of the application site were evaluated according to the criteria below. The worst score throughout the treatment period was used in the analysis.
-: no reaction, ±: mild erythema, +: erythema, ++: erythema and Oedema, +++: erythema and oedema and rash papular, or serous papule, or vesicles, ++++: bullosum"|Up to 55 weeks after dosing|SS||participants|||Number
676172|NCT01628965|Secondary|Total of Unified Parkinson's Disease Rating Scale (UPDRS) Part 2 Sum Score and Part 3 Sum Score|Mean change (LOCF) from baseline in Total of UPDRS Part 2 sum score and Part 3 sum up to 54 weeks after dosingUPDRS is a scale for monitoring Parkinson's Disease-related disability and impairment. The UPDRS consists of the following four sub-scales. Part 1: Mentation, Part 2: Activities of Daily Living, Part 3: Motor, Part 4: Complications. Part 2 assesses 13 items and Part 3 assesses 14 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement.|Baseline, Up to 54 weeks after dosing|Full analysis set (FAS), last observation carried forward (LOCF)||Scores on a scale||Standard Deviation|Mean
676173|NCT01628965|Primary|Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters|"Incidence and severity of adverse events, vital signs, and laboratory parameters up to 54 weeks after dosing.
*decrease in difference between supine and standing systolic blood pressure"|Up to 55 weeks after dosing|Safety set (SS)||participants|||Number
676174|NCT01628926|Secondary|Dystonia (in the Daytime)|Change (LOCF) from baseline in occurrence of Dystonia (in the daytime).|Baseline, 16 weeks after dosing|Appropriate interpretation for this outcome measure was not possible, because 87.1% (142/163), 88.5% (146/165), and 91.4% (74/81) of the subjects in the SPM 962, Ropinirole, and Placebo groups, respectively, had no dystonia in the day time at baseline.||Percentage of Participants|||Number
676175|NCT01628926|Secondary|Dystonia (at an Early Hour)|Change (LOCF) from baseline in occurrence of Dystonia (at an early hour).|Baseline, 16 weeks after dosing|FAS, LOCF Evaluation for this outcome measure was not possible, because 87.1% (142/163), 88.5% (146/165), and 91.4% (74/81) of the subjects in the SPM 962, Ropinirole, and Placebo groups, respectively, had no dystonia in the day time at baseline.||Percentage of participants|||Number
676176|NCT01628926|Secondary|Clinical Global Impression (CGI)|"Change (LOCF) from baseline in CGI score. CGI improvement is a clinician-reported scale for assessing how much the patient's illness has improved or worsened from baseline.
The scale scoring criteria are 1: very much improved, 2: much improved, 3: minimally improved, 4: no change, 5: minimally worse, 6: much worse, 7: very much worse. A decrease in the scores means improvement."|Baseline, 16 weeks after dosing|FAS, LOCF||Percentage of Participants|||Number
676177|NCT01628926|Secondary|Effective Rate in Off Time|"Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in off time at 16 weeks after dosing.
On-time is a state where L-Dopa is effective. On-time was measured by patient diary in hours/day."|Baseline, 16 weeks after dosing|FAS subjects with measurable off time data at baseline, LOCF||Percentage of participants||95% Confidence Interval|Number
676178|NCT01628926|Secondary|Effective Rate in UPDRS Part 2 Sum Score|Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in UPDRS Part 2 sum score (average scores of on state and off state) at 16 weeks after dosing.|Baseline, 16 weeks after dosing|FAS, LOCF||Percentage of participants||95% Confidence Interval|Number
676180|NCT01628926|Secondary|On Time With Dyskinesia Disturbing Daily Activities|Mean change (LOCF) from baseline in on time with dyskinesia disturbing daily activities at 16 weeks after dosing (rate against on time).|Baseline, 16 weeks after dosing|FAS, LOCF Evaluation for this outcome measure was not possible, because only 22.6% (37/164), 12.7% (21/165), and 6.0% (5/83) of the subjects in the SPM 962, Ropinirole, and Placebo groups, respectively, had dyskinesia disturbing daily activities on either day from baseline until the end of titration/maintenance period.||Hours||Standard Deviation|Mean
676181|NCT01628926|Secondary|On Time Without Dyskinesia Disturbing Daily Activities|"Mean change (LOCF) from baseline in on time without dyskinesia disturbing daily activities at 16 weeks after dosing.
On-time is a state where L-Dopa is effective. On-time was measured by patient diary in hours/day."|Baseline, 16 weeks after dosing|FAS, LOCF Evaluation for this outcome measure was not possible, because only 22.6% (37/164), 12.7% (21/165), and 6.0% (5/83) of the subjects in the SPM 962, Ropinirole, and Placebo groups, respectively, had dyskinesia disturbing daily activities on either day from baseline until the end of titration/maintenance.||Hours/day||Standard Deviation|Mean
676182|NCT01628926|Secondary|On Time|Mean change (LOCF) from baseline in on time at 16 weeks after dosing. On-time is a state where L-Dopa is effective. On-time was measured by patient diary in hours/day.|Baseline, 16 weeks after dosing|FAS, LOCF||Hours/day||Standard Deviation|Mean
676183|NCT01628926|Secondary|Parkinson's Disease Sleep Scale-2 (PDSS-2)|Mean change (LOCF) from baseline in PDSS-2 sum score at 16 weeks after dosing. PDSS-2 is a scale for assessing sleep disorders in Parkinson's disease. PDSS consists of 15 questions about sleep and nocturnal disturbances. The score of each question ranges from 0 (never) to 4 (very frequent). The sum of each question serves as the scale score. Thus a decrease in the scores means improvement.|Baseline, 16 weeks after dosing|FAS, LOCF||Scores on a scale||Standard Deviation|Mean
676184|NCT01628926|Secondary|Off Time|Mean change (LOCF) from baseline in off time at 16 weeks after dosing. Off-time is a state where L-Dopa becomes ineffective. Off-time was measured by patient diary in hours/day.|Baseline, 16 weeks after dosing|FAS subjects with measurable off time data at baseline, LOCF||Hours/day||Standard Deviation|Mean
676185|NCT01628926|Secondary|UPDRS Part 2 Sum Score|"Mean change (LOCF) from baseline in UPDRS Part 2 sum score (average scores of on state and off state) at 16 weeks after dosing.
UPDRS 2 assesses 13 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, 16 weeks after dosing|FAS, LOCF||Scores on a scale||Standard Deviation|Mean
676186|NCT01628926|Secondary|UPDRS Part 3 Sum Score|"Mean change (LOCF) from baseline in UPDRS Part 3 sum score (on state) at 8 and 10 weeks after dosing.
UPDRS Part 3 assesses 14 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|baseline, 8 and 10 weeks after dosing|FAS, LOCF||Scores on a scale||Standard Deviation|Mean
676187|NCT01628926|Primary|Unified Parkinson's Disease Rating Score (UPDRS) Part 3 Sum Score|"Mean change (LOCF) from baseline in UPDRS Part 3 sum score (on state) at 16 weeks after dosing.
UPDRS is a scale for monitoring Parkinson's Disease-related disability and impairment. The UPDRS consists of the following four sub-scales. Part 1: Mentation, Part 2: Activities of Daily Living, Part 3: Motor, Part 4: Complications. Part 3 assesses 14 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|baseline, 16 weeks after dosing|Full analysis set (FAS), last observation carried forward (LOCF)||Scores on a scale||Standard Deviation|Mean
676188|NCT01628913|Secondary|Time to Treatment Failure (TTF)|Time from randomization to the date of the first of the following events:death due to any cause or progressive disease, treatment discontinuation due to toxicity or treatment discontinuation due to patient preference|up to approx. 18 months|Trial terminated based on the results of an interim analysis of the primary OM ( which demonstrated BEX235 not having improved PFS (progression free survival) vs everolimus).The secondary OM analyses were not conducted.|||||
676189|NCT01628913|Secondary|Overall Survival (OS)|Time from randomization to the date of death due to any cause|up to approx. 30 months|Trial terminated based on the results of an interim analysis of the primary OM ( which demonstrated BEX235 not having improved PFS (progression free survival) vs everolimus).The secondary OM analyses were not conducted.|||||
676190|NCT01628913|Secondary|Objective Response Rate|Proportion of patients with a best overall response during the study of complete response (CR) or partial response (PR), based on the investigator assessment. 2. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for all target and non-target lesions, as well as new lesions as assessed by CT or MRI: Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of all target lesions; Overall Response (OR) = CR + PR.|up to approx. 18 months|Trial terminated based on the results of an interim analysis of the primary OM ( which demonstrated BEX235 not having improved PFS (progression free survival) vs everolimus).The secondary OM analyses were not conducted.|||||
676191|NCT01628913|Primary|Progression Free Survival (PFS)|PFS is defined as the time from the date of randomization until the date of the first radiologically documented disease progression or death due to any cause. PFS is based on local investigator assessment. Patients will be followed up for the duration of the study and for an expected average of every 12 weeks after randomization. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of all target lesions, or unequivocal progression of non-target lesions, or the appearance of new lesions.|up to approx. 18 months|Full analysis set: The Full analysis set (FAS) comprised all patients who were randomized to study treatment. According to the intent to treat principle, patient was analyzed according to the treatment and strata they had been assigned to during the randomization procedure.||Months||95% Confidence Interval|Median
676192|NCT01628848|Secondary|The Modified Hoehn & Yahr Severity of Illness|"Mean change (LOCF) from baseline in the Modified Hoehn & Yahr Severity of Illness at 12 weeks after dosing.
The Modified Hoehn & Yahr criteria are measured on the following 8-point scale for staging: 0, No signs of disease; 1, Unilateral disease; 1.5, Unilateral plus axial involvement; 2, Bilateral disease without impairment of balance; 2.5, Mild bilateral disease with recovery on pull test; 3, Mild to moderate bilateral disease, some postural instability, physically independent 4, Severe disability, still able to walk or stand unassisted; and 5, Wheelchair bound or bedridden unless aided."|Baseline, 12 weeks after dosing|FAS, LOCF||Percentage of participants|||Number
676193|NCT01628848|Secondary|Total of UPDRS Part 1 Sum Score, UPDRS Part 2 Sum Score (Average Score of on State and Off State), UPDRS Part 3 Sum Score, and UPDRS Part 4 Sum Score.|"Mean change (LOCF) from baseline in total of UPDRS Part 1 sum score, UPDRS Part 2 sum score (average score of on state and off state), UPDRS Part 3 sum score, and UPDRS Part 4 sum score at 12 weeks after dosing.
UPDRS sub-scale Part 1, 2, 3, and 4 assess 4, 13, 14, and 11 items respectively. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, 12 weeks after dosing|FAS, LOCF||Scores on a scale||Standard Deviation|Mean
676194|NCT01628848|Secondary|Total of UPDRS Part 2 Sum Score (Average Score of on State and Off State) and UPDRS Part 3 Sum Score|"Mean change (LOCF) from baseline in total of UPDRS Part 2 sum score (average score of on state and off state), and UPDRS Part 3 sum score at 12 weeks after dosing.
UPDRS sub-scale Part 2 assesses 13 items and Part 3 assesses 14 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, 12 weeks after dosing|FAS, LOCF||Scores on a scale||Standard Deviation|Mean
676195|NCT01628848|Secondary|UPDRS Part 4 Sum Score|"Mean change (LOCF) from baseline in UPDRS Part 4 sum score at 12 weeks after dosing.
UPDRS sub-scale Part 4 assesses 11 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, 12 weeks after dosing|FAS, LOCF||Scores on a scale||Standard Deviation|Mean
676196|NCT01628848|Secondary|UPDRS Part 2 Sum Score (Off State)|"Mean change (LOCF) from baseline in UPDRS Part 2 sum score (off state) at 12 weeks after dosing.
UPDRS sub-scale Part 2 assesses 13 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, 12 weeks after dosing|FAS, LOCF||Scores on a scale||Standard Deviation|Mean
676197|NCT01628848|Secondary|UPDRS Part 2 Sum Score (on State)|"Mean change (LOCF) from baseline in UPDRS Part 2 sum score (on state) at 12 weeks after dosing.
UPDRS sub-scale Part 2 assesses 13 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, 12 weeks after dosing|FAS, LOCF||Scores on a scale||Standard Deviation|Mean
676198|NCT01628848|Secondary|Effective Rate in Off Time|Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in off time at 12 weeks after dosing.|Baseline, 12 weeks after dosing.|FAS subjects with measurable off time data at baseline, LOCF||Percentage of participants||95% Confidence Interval|Number
676199|NCT01628848|Secondary|UPDRS Part 1 Sum Score|"Mean change (LOCF) from baseline in UPDRS Part 1 sum score at 12 weeks after dosing.
UPDRS sub-scale Part 1 assesses 4 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, 12 weeks after dosing|FAS, LOCF||Scores on a scale||Standard Deviation|Mean
676200|NCT01628848|Secondary|Effective Rate in UPDRS Part 3 Sum Score|Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in UPDRS Part 3 sum score at 12 weeks after dosing.|Baseline, 12 weeks after dosing|FAS, LOCF||Percentage of participants||95% Confidence Interval|Number
676201|NCT01628848|Secondary|Off Time|Mean change (LOCF) from baseline in off time at 12 weeks after dosing.|baseline, 12 weeks after dosing|FAS subjects with measurable off time data at baseline, LOCF||Hours||Standard Deviation|Mean
676202|NCT01628848|Secondary|UPDRS Part 2 Sum Score (Average Score of on State and Off State)|"Mean change (LOCF) from baseline in UPDRS Part 2 sum score (average scores of on state and off state) at 12 weeks after dosing.
Mean change (LOCF) from baseline in UPDRS Part 2 sum score (average score of on state and off state) at 12 weeks after dosing.
UPDRS sub-scale Part 2 assesses 13 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|baseline, 12 weeks after dosing|FAS, LOCF||Scores on a scale||Standard Deviation|Mean
676203|NCT01628848|Primary|Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 Sum Score|"Mean change (LOCF) from baseline in UPDRS Part 3 sum score at 12 weeks after dosing.
UPDRS is a scale for monitoring Parkinson's Disease-related disability and impairment. The UPDRS consists of the following four sub-scales. Part 1: Mentation, Part 2: Activities of Daily Living, Part 3: Motor, Part 4: Complications. Part 3 assesses 14 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|baseline, 12 weeks after dosing|Full analysis set (FAS), last observation carried forward (LOCF)||Scores on a scale||Standard Deviation|Mean
676204|NCT01628692|Secondary|Number of Participants With Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs) and Who Died|AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Based on the severity, AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.|From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)|All treated participants.||Participants|||Number
676205|NCT01628692|Secondary|Percentage of Participants With Sustained Virologic Response at Week 12 (SVR12) by rs12979860 Single Nucleotide Polymorphisms in the IL-28B Gene Categories|Participants were categorized into 3 genotypes based on single nucleotide polymorphisms in the IL28B gene. SVR12 was defined as hepatitis C virus (HCV) RNA levels below lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Baseline, post-treatment Week 12 (Follow-up period)|All treated participants. Here ‘n’ signifies those participants evaluable for this measure at specified time points for each group, respectively.||Percentage of participants|||Number
676375|NCT01625507|Primary|Change in Macronutrient Intake|Measured using repeated 24 hour dietary recalls (pre and post-intervention)|3 months|||percentage of total energy||95% Confidence Interval|Mean
676206|NCT01628692|Secondary|Percentage of Participants With End of Treatment Response (EOTR)|EOTR were defined as hepatitis C virus (HCV) RNA levels <lower limit of quantitation, target not detected at end of treatment. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|End of treatment (Week 24)|All treated participants.||Percentage of participants||80% Confidence Interval|Number
676207|NCT01628692|Secondary|Percentage of Participants With Extended Rapid Virologic Response (eRVR)|eRVR were defined as hepatitis C virus (HCV) RNA levels to be <lower limit of quantitation, target not detected at both Week 4 and Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 4 and Week 12|All treated participants.||Percentage of participants||80% Confidence Interval|Number
676208|NCT01628692|Primary|Percentage of Participants With Sustained Virologic Response Rate at Post-treatment Week 12 (SVR12)|SVR12 rate was defined as hepatitis C virus (HCV) RNA levels to be <lower limit of quantitation, target detected or target not detected, at post-treatment Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Post Treatment Week 12 (Follow-up period)|All participants who were randomized and received at least 1 dose of active study therapy (daclatasvir, simeprevir, ribavirin).||Percentage of participants||80% Confidence Interval|Number
676209|NCT01628692|Secondary|Percentage of Participants With Complete Early Virologic Response (cEVR)|cEVR was defined as hepatitis C virus (HCV) RNA levels to be <lower limit of quantitation, target not detected at Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 12|All treated participants.||Percentage of participants||80% Confidence Interval|Number
676210|NCT01628692|Secondary|Percentage of Participants With Rapid Virologic Response (RVR) at Week 4|RVR was defined as hepatitis C virus (HCV) RNA levels to be <lower limit of quantitation, target not detected at Week 4. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 4|All treated participants.||Percentage of participants||80% Confidence Interval|Number
676211|NCT01628614|Secondary|Percentage of Patients With an IOP Reduction ≥20% From Baseline|Percentage of patients with an IOP reduction ≥20% from baseline. IOP is a measurement of the fluid pressure inside the eye. The minimum reduction of 20% was evaluated in the eye with the highest pressure at the baseline visit.|Baseline, 14 Weeks|Evaluable Patients: all patients who met the study entry criteria||Percentage of Patients|||Number
676212|NCT01628614|Secondary|Percentage of Patients With an IOP Reduction ≥10% From Baseline|Percentage of patients with an IOP reduction ≥10% from baseline. IOP is a measurement of the fluid pressure inside the eye. The minimum reduction of 10% was evaluated in the eye with the highest pressure at the baseline visit.|Baseline, 14 Weeks|Evaluable Patients: all patients who met the study entry criteria||Percentage of Patients|||Number
676213|NCT01628614|Primary|Percentage of Patients With a Reduction in Intraocular Pressure (IOP) ≥ 5mmHg From Baseline|Percentage of patients with a reduction in IOP≥5 mmHg from baseline. IOP is a measurement of the fluid pressure inside the eye. The minimum reduction of 5 mmHg was evaluated in the eye with the highest pressure at the baseline visit.|Baseline, 14 Weeks|Evaluable Patients: all patients who met the study entry criteria||Millimeters of Mercury (mmHg)|||Number
676214|NCT01628601|Secondary|Patients Continuing With GANfort® After 18 Weeks|Patients continuing with GANfort® after 18 weeks was assessed as Yes or No.|18 Weeks|All enrolled patients with complete data for this outcome measure||Participants|||Number
676215|NCT01628601|Secondary|Physician Assessment of Adherence to GANfort®|"Physician Assessment of Adherence to GANfort® was assessed on a 3-point scale (better, equal, and worse). The number of patients assessed as better compliance are reported."|18 Weeks|All enrolled patients with complete data for this outcome measure||Participants|||Number
676216|NCT01628601|Secondary|Patient Assessment of Tolerability Using a 4-Point Scale|Patient assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed as good and very good combined are reported.|18 Weeks|All enrolled patients with complete data for this outcome measure||Participants|||Number
676217|NCT01628601|Secondary|Physician Assessment of Tolerability Using a 4-Point Scale|Physician assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed as good and very good combined are reported.|18 Weeks|All enrolled patients with complete data for this outcome measure||Participants|||Number
676218|NCT01628601|Primary|Change From Baseline in Intraocular Pressure (IOP)|IOP is a measurement of the fluid pressure inside the eye. A negative change from baseline indicates an improvement.|Baseline, 18 Weeks|All enrolled patients with complete data for this outcome measure||Millimeters of Mercury (mmHg)||Inter-Quartile Range|Median
676219|NCT01628588|Secondary|Patients Who Will Continue Use of Lumigan® After 14 Weeks|Patients who will continue use of Lumigan® after 14 weeks was assessed as Yes or No.|14 Weeks|All enrolled patients with complete data for this outcome measure||Participants|||Number
676220|NCT01628588|Secondary|Patients Who Discontinued Use of Lumigan® Prior to 14 Weeks|Patients who discontinued Lumigan® prior to 14 weeks was assessed as Yes or No.|14 Weeks|All enrolled patients with complete data for this outcome measure||Participants|||Number
676221|NCT01628588|Secondary|Physician Assessment of Tolerability Using a 4-Point Scale|Physician assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed as good and very good combined are reported.|14 Weeks|All enrolled patients with complete data for this outcome measure||Participants|||Number
676222|NCT01628588|Secondary|Patient Assessment of Tolerability Using a 4-Point Scale|Patient assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed as good and very good combined are reported.|14 Weeks|All enrolled patients with complete data for this outcome measure||Participants|||Number
676223|NCT01628588|Primary|Change From Baseline in Intraocular Pressure (IOP)|IOP is a measurement of the fluid pressure inside the eye. A negative change from baseline indicates an improvement.|Baseline, 14 Weeks|All enrolled patients with complete data for this outcome measure||Millimeters of Mercury (mmHg)||Inter-Quartile Range|Median
676224|NCT01628510|Secondary|The Bayley Scales of Infant Development-3rd Edition (BSID-III)|The BSID-III is the gold standard for assessing developmental outcome in childhood. Domain scores for language, motor and cognition will be determined.|6 months, 1 year, 2 years and 3 years||||||
676225|NCT01628510|Primary|NICU Network Neurobehavioral Scale (NNNS)|The NNNS wasl used to assess neurobehavioral outcome near term equivalent (between 35 weeks and 41 weeks postmenstrual age). This tool consists of eliciting neonatal reflexes and observing behavior. From the assessment, 13 summary scores were determined for each of the following constructs: habituation (1-9), orientation (1-9), self regulation (1-9), tolerance of handling (0-1), hypertonia (0-10), hypotonia (0-10), asymmetry (0-16), lethargy (0-15), excitability (0-15), sub-optimal reflexes (0-15), arousal (1-9), quality of movement (1-9) and stress (0-1). Each summary score is analyzed for associations with subsequent developmental outcome. A higher score in each category indicates more of that construct. Specifically, for the summary score of asymmetry (the significant finding in this study), higher scores equal more asymmetry.|35 to 41 weeks (term equivalent); prior to NICU discharge|||Asymmetry Score (units on a scale)||Standard Deviation|Mean
676226|NCT01628367|Secondary|Pink Esthetic Score|Pink esthetic score per Furhauser et.al. measured at study conclusion where based on seven variables: mesial papilla, distal papilla, soft-tissue level, soft-tissue contour, alveolar process deficiency, soft-tissue color and texture (Fig. 1). Each variable was assessed with a 2-1-0 score, with 2 being the best and 0 being the poorest score. Thus a maximum score of 14 is best, and 0 is the worst.|One year|||units on a scale||Standard Deviation|Mean
676227|NCT01628367|Secondary|Change in Interproximal Bone Levels|Change of interproximal marginal bone loss (mean of mesial and distal sites)|One year|||millimeters||Standard Deviation|Mean
676228|NCT01628367|Primary|Change in Thickness of Buccal Bone|Change of buccal bone volume over study duration|One year|||millimeters||Standard Deviation|Mean
676229|NCT01628250|Secondary|Survival Rate|The follow up to the patients after the surgery to evaluate the oncological results of the technique|3 years after the surgery||||||
676230|NCT01628250|Primary|Histopathological Outcomes Obtained Through the Surgeries|number of lymph nodes retrieved|14 days after the surgery|||nodes||Standard Deviation|Mean
676231|NCT01628042|Primary|Apparent Total Body Clearance (CL/F) After a Single Oral Dose of Vibegron 100 mg|Blood samples were collected predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours after dosing in order to determine CL/F after a single oral dose of vibegron 100 mg.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours postdose|PP population, which included participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of treatment, according to the underlying scientific model.||L/hr||95% Confidence Interval|Geometric Mean
676232|NCT01628042|Primary|Maximum Plasma Concentration (Cmax) After a Single Oral Dose of Vibegron 100 mg|Blood samples were collected predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours after dosing in order to determine Cmax after a single oral dose of vibegron 100 mg.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours postdose|PP population, which included participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of treatment, according to the underlying scientific model.||nM||95% Confidence Interval|Geometric Mean
676233|NCT01628042|Primary|Area Under the Concentration-time Curve From 0 to Infinity (AUC0-∞) After a Single Oral Dose of Vibegron 100 mg|Blood samples were collected predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours after dosing in order to determine AUC0-∞ after a single oral dose of vibegron 100 mg.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours postdose|Per Protocol (PP) population, which included participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of treatment, according to the underlying scientific model.||nM•hr||95% Confidence Interval|Geometric Mean
676234|NCT01627860|Secondary|Dosage Administration of Topamax During Month 4||Month 4|Participants who have received study medication during month 4.||mg||Standard Deviation|Mean
676235|NCT01627860|Secondary|Seizure Frequency: Percent Change of Seizure Frequency by the ANCOVA Model During the Month 4|Seizure frequency (seizure count/month) was calculated based on the number of seizure within a month. The mean seizure frequency analyzed by the ANCOVA model at each period.|Baseline (4 weeks retrospective assessment prior to start of titration period) to Month 4|Intent-To-Treat population: All randomized participants who received at least one dose of study medication.||Percent change||Standard Deviation|Mean
676236|NCT01627860|Primary|Seizure Free Rate: Percentage of Participants Who Did Not Have Any Seizure Episode Within the Last Month of the Maintenance Period (ie, Month 4).||Month 4|Intent-To-Treat population: All randomized participants who received at least one dose of study medication.||Percentage of participants|||Number
676237|NCT01627782|Secondary|Elimination Half-Life (t1/2)|The elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).|Pre-infusion, 20, 40 (End of the Infusion), 45, 50, 60, 90, 120, 180, 240 and 360 minutes post-infusion on Day 1 and Day 15|An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,“N”(Number of Participants Analyzed) and “n” signifies those participants who were evaluable for this outcome measure and at given time point, respectively||hour||Standard Deviation|Mean
676238|NCT01627782|Secondary|Volume of Distribution at Steady-State (Vss) of Ketamine|The Vss is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of ketamine at steady state.|Pre-infusion, 20, 40 (End of the Infusion), 45, 50, 60, 90, 120, 180, 240 and 360 minutes post-infusion on Day 1 and Day 15|An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,“N”(Number of Participants Analyzed) and “n” signifies those participants who were evaluable for this outcome measure and at given time point, respectively||liter||Standard Deviation|Mean
676239|NCT01627782|Secondary|Total Systemic Clearance (CL) of Ketamine|The CL is a quantitative measure of the rate at which a drug substance is removed from the body.|Pre-infusion, 20, 40 (End of the Infusion), 45, 50, 60, 90, 120, 180, 240 and 360 minutes post-infusion on Day 1 and Day 15|An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,“N”(Number of Participants Analyzed) and “n” signifies those participants who were evaluable for this outcome measure and at given time point, respectively||liter per hour||Standard Deviation|Mean
676240|NCT01627782|Secondary|Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])|The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC (last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.|Pre-infusion, 20, 40 (End of the Infusion), 45, 50, 60, 90, 120, 180, 240 and 360 minutes post-infusion on Day 1 and Day 15|An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,“N”(Number of Participants Analyzed) and “n” signifies those participants who were evaluable for this outcome measure and at given time point, respectively||hour*nanogram per milliliter||Standard Deviation|Mean
676241|NCT01627782|Secondary|Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC[0-last])|The AUC(0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time.|Pre-infusion, 20, 40 (End of the Infusion), 45, 50, 60, 90, 120, 180, 240 and 360 minutes post-infusion on Day 1 and Day 15|An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,“N”(Number of Participants Analyzed) and “n” signifies those participants who were evaluable for this outcome measure and at given time point, respectively||hour*nanogram per milliliter||Standard Deviation|Mean
676242|NCT01627782|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Ketamine|The Tmax is defined as actual sampling time to reach maximum observed drug concentration.|Pre-infusion, 20, 40 (End of the Infusion), 45, 50, 60, 90, 120, 180, 240 and 360 minutes post-infusion on Day 1 and Day 15|An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,“N”(Number of Participants Analyzed) and “n” signifies those participants who were evaluable for this outcome measure and at given time point, respectively||Hour||Full Range|Median
676243|NCT01627782|Secondary|Maximum Observed Plasma Concentration (Cmax) of Ketamine|The Cmax is the maximum observed plasma concentration of drug.|Pre-infusion, 20, 40 (End of the Infusion), 45, 50, 60, 90, 120, 180, 240 and 360 minutes post-infusion on Day 1 and Day 15|An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,“N”(Number of Participants Analyzed) and “n” signifies those participants who were evaluable for this outcome measure and at given time point, respectively||nanogram per milliliter (ng/ml)||Standard Deviation|Mean
676244|NCT01627782|Secondary|Patient Global Impression-Change (PGI-C) Score at Endpoint of Double Blind Phase|The PGI-C is a 7-point scale that required the subject to assess how much their illness had improved or worsened relative to a baseline state at the beginning of the intervention. The response options were: very much improved; much improved; improved (just enough to make a difference); no change; worse (just enough to make a difference); much worse; or very much worse. The scale is rated as, 1=very much improved and 7=very much worse.|Endpoint (Day 29)|An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,“N”(Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.||Units on a scale||Full Range|Median
676245|NCT01627782|Secondary|Change in Patient Global Impression-Severity (PGI-S) Score From Baseline to Endpoint (Day 29)|The PGI-S is an 11-point (0 to 10) scale that required the participant to rate the severity of their illness at the time of assessment, relative to the participants past experience. Considering their total experience, the participant was to assess the severity of their depression illness at the time of rating as none, mild, moderate or severe. The scale is rated as, 0=very well and 10=very poor.|Baseline (Day 1) and Endpoint (Day 29)|An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,“N”(Number of Participants Analyzed) and “n” signifies those participants who were evaluable for this outcome measure and at given time point, respectively||Units on a scale||Full Range|Median
676246|NCT01627782|Secondary|Clinical Global Impression of Improvement (CGI-I) Score at Endpoint of Double Blind Phase|The CGI-I is a 7-point scale that was used to assess how much the participants illness was improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 0= not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.|Endpoint (Day 29)|An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,“N”(Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.||Units on a scale||Full Range|Median
676247|NCT01627782|Secondary|Change in Clinical Global Impression-Severity (CGI-S) Score From Baseline to Endpoint (Day 29)|The CGI-S was used to rate the severity of the participants illness at the time of assessment, relative to the clinician’s past experience with participants who had the same diagnosis and improvement with treatment. Considering total clinical experience, a participant was assessed on severity of mental illness at the time of rating according to: 0= not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill participants.|Baseline (Day 1) and Endpoint (Day 29)|An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,“N”(Number of Participants Analyzed) and “n” signifies those participants who were evaluable for this outcome measure and at given time point, respectively||Units on a scale||Full Range|Median
676272|NCT01627561|Secondary|Anti-HPV-16/18 Antibody Concentrations|"Antibody concentrations were calculated as geometric mean concentrations (GMCs), assessed by ELISA for the respective groups and expressed as ELISA units per milliliter (EU/mL).
Values for Month 7 were primary outcomes and presented as such. Values past month 7 were not available at the time of posting this record and will be added once validated results become available."|At Day 0, Month 7 and Month 12|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all eligible subjects (i.e. meeting all eligibility criteria, complying with the procedures defined in the protocol) for whom data concerning immunogenicity outcome measures were available.||EU/mL||95% Confidence Interval|Geometric Mean
676248|NCT01627782|Secondary|Number of Sustained Responders Based on Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|Sustained response on Day 15 was defined as achieving an onset of antidepressant response within the first week that is maintained to the end of study Day 15. The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total score of 60. Higher scores represent a more severe condition.|Day 15|An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here, “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.||Participants|||Number
676249|NCT01627782|Secondary|Number of Remitters Based on Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|Participants who had a MADRS total score of less than or equal to (<=) 10 were considered remitters. The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total score of 60. Higher scores represent a more severe condition.|Day 15 and Day 29|An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,“N”(Number of Participants Analyzed) and “n” signifies those participants who were evaluable for this outcome measure and at given time point, respectively||Participants|||Number
676250|NCT01627782|Secondary|Number of Responders Based on Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|Participants with a reduction in the MADRS total score of greater than or equal to (>=) 50 percent from baseline were defined as responders. The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total score of 60. Higher scores represent a more severe condition.|Day 15 and Day 29|An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,“N”(Number of Participants Analyzed) and “n” signifies those participants who were evaluable for this outcome measure and at given time point, respectively||Participants|||Number
676251|NCT01627782|Secondary|Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Day 29|The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total score of 60. Higher scores represent a more severe condition.|Baseline (Day 1) and Day 29|An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,“N”(Number of Participants Analyzed) and “n” signifies those participants who were evaluable for this outcome measure and at given time point, respectively||Units on a scale||Standard Deviation|Mean
676252|NCT01627782|Primary|Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Day 15|The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total score of 60. Higher scores represent a more severe condition.|Baseline (Day 1) and Day 15|An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,“N”(Number of Participants Analyzed) and “n” signifies those participants who were evaluable for this outcome measure and at given time point, respectively||Units on a scale||Standard Deviation|Mean
676253|NCT01627561|Secondary|Number of Subjects With of AEs/SAEs Leading to Withdrawal||From Day 0 to Month 12|||Subjects|||Number
676254|NCT01627561|Secondary|The Number of Subjects Completing the Vaccination Schedule in All Groups.||From first vaccination to the last vaccine dose (from Day 0 up to Month 6)|||Subjects|||Number
676255|NCT01627561|Secondary|Number of Subjects Reporting the Intake of Concomitant Medication||During the 43-day period (Days 0-42) following vaccination on Day 0 and during the 30-day period (Days 0-29) following vaccination at Month 6|||Subjects|||Number
676256|NCT01627561|Secondary|Number of Subjects With of AEs/SAEs Leading to Withdrawal||Throughout the study period (From Day 0 to Month 36)||12/2016||||
676257|NCT01627561|Secondary|Number of Subjects With Serious Adverse Events (SAEs)||Throughout the study period (From Day 0 to Month 36)||12/2017||||
676258|NCT01627561|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From first vaccination to 6 months after the last vaccine dose (from Day 0 up to Month 12)|||Subjects|||Number
676259|NCT01627561|Secondary|Number of Subjects With Medically Significant Conditions (MSCs)|MSCs include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|From first vaccination to 6 months after the last vaccine dose (from Day 0 up to Month 12)|||Subjects|||Number
676260|NCT01627561|Secondary|Number of Subjects With Potential Immune-mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology|From first vaccination to 6 months after the last vaccine dose (from Day 0 up to Month 12)|||Subjects|||Number
676261|NCT01627561|Secondary|The Number of Subjects With Solicited Fever, Measles/Rubella-like Rash, Parotid Gland Swelling and Signs of Meningism, Including Febrile Convulsion||During the 43-day period (Days 0-42) following vaccination on Day 0|||Subjects|||Number
676262|NCT01627561|Secondary|Seroprotection Rates to Diphtheria (D) and Tetanus (T) Antigens in Groups HPV_2D, MMR_DTPa and HPV_2D CO.||At Month 7||12/2016||||
676273|NCT01627561|Secondary|Number of Subjects Seroconverted for Anti-HPV-16/18 Antibodies|"Seroconversion is defined as the appearance of antibodies (i.e. titre greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.
Values for Month 7 were primary outcomes and presented as such. Values past month 7 were not available at the time of posting this record and will be added once validated results become available."|At Day 0, Month 7 and Month 12|This analysis was based on the ATP cohort for immunogenicity, which included all eligible subjects (i.e. meeting all eligibility criteria, complying with the procedures defined in the protocol) for whom data concerning immunogenicity outcome measures were available.||Subjects|||Number
676274|NCT01627561|Primary|Anti-HPV-16/18 Antibody Concentrations|Antibody concentrations were assessed by Enzyme-linked-Immunosorbent Assay (ELISA) and expressed as geometric mean titers (GMTs) in ELISA units per milliliter (EU/mL).|One month after the last dose of study vaccine (Month 7)|The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects (i.e. meeting all eligibility criteria, complying with the procedures defined in the protocol) for whom data concerning immunogenicity outcome measures were available.||EU/mL||95% Confidence Interval|Geometric Mean
676275|NCT01627561|Primary|Number of Serconverted Subjects for Anti-HPV-16/18|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer.|One month after the last dose of study vaccine (Month 7)|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all eligible subjects (i.e. meeting all eligibility criteria, complying with the procedures defined in the protocol) for whom data concerning immunogenicity outcome measures were available.||Subjects|||Number
676276|NCT01627561|Primary|Number of Subjects With Medically Significant Conditions (MSCs)|MSCs include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|From first vaccination to one month after the last vaccine dose (from Day 0 up to Month 7)|||Subjects|||Number
676277|NCT01627561|Primary|Number of Subjects With Potential Immune-mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology|From first vaccination to one month after the last vaccine dose (from Day 0 up to Month 7)|||Subjects|||Number
676278|NCT01627561|Primary|Number of Subjects With AEs and SAEs Leading to Withdrawal||From first vaccination to one month after the last vaccine dose (from Day 0 up to Month 7)|||Subjects|||Number
676279|NCT01627561|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From first vaccination to one month after the last vaccine dose (from Day 0 up to Month 7)|||Subjects|||Number
676280|NCT01627561|Primary|Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters|The parameters assessed were both biochemical (alanine aminotransferase = ALAT, creatinine = CREA, urea nitrogen = BUN) and haematological (basophils = BAS, eosinophils = EOS, red blood cells = RBC, hematocrit = HCT, hemoglobin, leukocytes [white blood cells] = WBC, lymphocytes, monocytes, neutrophils and platelets). Results were split into 2 outcomes due to the table size.|42 days post dose 1 (PRE) and at 30 days post dose 2 (POST)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects (i.e. subjects who received at least one dose of vaccine in this study) for whom data were available.||Subjects|||Number
676281|NCT01627561|Primary|Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters.|The parameters assessed were both biochemical (alanine aminotransferase = ALAT, creatinine = CREA, urea nitrogen = BUN) and haematological (basophils = BAS, eosinophils = EOS, red blood cells = RBC, hematocrit = HCT, hemoglobin, leukocytes [white blood cells] = WBC, lymphocytes, monocytes, neutrophils and platelets). Results were split into 2 outcomes due to the table size.|42 days post dose 1 (PRE) and at 30 days post dose 2 (POST)|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects (i.e. subjects who received at least one dose of vaccine in this study) for whom data were available.||Subjects|||Number
676282|NCT01627561|Primary|Number of Subjects With Unsolicited Any, Grade 3 and Related Adverse Events (AEs).|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 30-day period (Days 0-29) post vaccination Dose 2 at Month 6|Note: Out of the 74 subjects present in the initial Priorix + Infanrix Group, 3 did not receive the second vaccination and were hence excluded from the TVc.||Subjects|||Number
676283|NCT01627561|Primary|Number of Subjects With Unsolicited Any, Grade 3 and Related Adverse Events (AEs).|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 43-day period (Days 0-42) post vaccination Dose 1|||Subjects|||Number
676284|NCT01627561|Primary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.|Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], headache, myalgia, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day period (Days 0-6) following each vaccination|||Subjects|||Number
676285|NCT01627561|Primary|Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Relationship analysis was not performed.|During the 7-day period (Days 0-6) following each vaccination|||Subjects|||Number
676286|NCT01627340|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs)|A serious adverse event was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination.|During the entire study period (Month 0 - Month 7)|The analysis was performed on the Total Vaccinated cohort, which included all subjects who received at least one study vaccine administration.||Subjects|||Number
676287|NCT01627340|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)|An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 31-day (Days 0-30) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects who received at least one study vaccine administration.||Subjects|||Number
676288|NCT01627340|Secondary|Number of Subjects Reporting Any Solicited General Symptoms|Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache and fever. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Any fever = oral temperature greater than or equal to (≥) 37.5 degrees Celsius (°C)|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on Total Vaccinated cohort, which included all subjects who received at least one study vaccine administration and had symptom sheet completed.||Subjects|||Number
676289|NCT01627340|Secondary|Number of Subjects Reporting Any Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of the specified solicited local symptom regardless of its intensity grade.|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on Total Vaccinated cohort, which included all subjects who received at least one study vaccine administration and had symptom sheet completed.||Subjects|||Number
676290|NCT01627340|Secondary|Anti-HBs Antibody Concentration|Concentrations were given as geometric mean concentration (GMC) and expressed as mIU/mL|At one month after the third dose of primary vaccination (Month 7)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who received all 3 doses of the EngerixTM-B vaccine, for whom post-vaccination immunogenicity results were available and for those in the Control Group, a suitable match was available in the Diabetic Group.||mIU/mL||95% Confidence Interval|Geometric Mean
676291|NCT01627340|Primary|Number of Subjects Seroprotected for Anti- Hepatitis B Surface Antigen (Anti-HBs) Antibodies|A seroprotected subject was defined as a vaccinated subject with an anti-HBs antibody concentration greater than or equal to (≥) 10 milli-international units per milliliter (mIU/mL).|At one month after the third dose of primary vaccination (Month 7)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who received all 3 doses of the EngerixTM-B vaccine, for whom post-vaccination immunogenicity results were available and for those in the Control Group, a suitable match was available in the Diabetic Group.||Subjects|||Number
676292|NCT01627327|Secondary|Change From Baseline in Trough FEV1 at Treatment Day 84|Pulmonary function was measured by FEV1. Trough FEV1 was defined as the 24-hour FEV1 assessment, which was obtained on Day 84. Baseline is defined as the mean of the two assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1.Change from Baseline was calculated as the average of the Day 84 values minus the Baseline value. Analysis was performed using an ANCOVA model with covariates of BL FEV1, exacerbation history and reversibility stratum, smoking status at screening, country, and treatment group.|Baseline and Day 84|ITT Population. Only participants with data available at the indicated time point were assessed.||Liters||Standard Error|Least Squares Mean
676293|NCT01627327|Secondary|Time to Onset on Treatment Day 1|Time to onset on Treatment Day 1 is defined as the time to an increase of 100 milliliters (mL) from Baseline in FEV1. Time of onset was calculated over 0 to 4 hours (5 minutes (min), 15 min, 30 min, 60 min, 120 min, and 240 min) post-dose. Time to onset was analyzed using a log-rank test, stratified by exacerbation history and reversibility stratum.|Baseline and Day 1|ITT Population. Only participants with data available at the indicated time point were assessed.||Minutes||Full Range|Median
676294|NCT01627327|Primary|Change From Baseline Trough in 24-hour Weighted Mean FEV1 on Treatment Day 84|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. The weighted mean was calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5, 15, 30 minutes and 1, 2, 4, 6, 8, 12, 13, 14, 16, 20, and 24 hours on Treatment Day 84. Baseline trough FEV1 was the mean of the two assessments made 30 and 5 minutes pre-dose on Treatment Day 1. Change from Baseline (BL) was calculated as the average of the Day 84 values minus the Baseline value. Analysis was performed using an analysis of covariance (ANCOVA) model with covariates of BL FEV1, exacerbation history and reversibility stratum, smoking status at screening, country, and treatment group.|Baseline and Day 84|Intent-to-Treat (ITT) Population: all participants who were randomized and received at least one dose of study medication. Only participants with data available at the indicated time point were assessed.||Liters||Standard Error|Least Squares Mean
676295|NCT01627249|Secondary|Eyes Receiving 1 or More Alternative Treatments for DME Other Than Laser||Baseline to 1-year|||Eyes|||Number
676296|NCT01627249|Secondary|Total Number of Laser Treatments|Only includes participants that completed the 1 year visit.|between 24 weeks and 1 year|||participants|||Number
676297|NCT01627249|Secondary|Total Number of Injections Prior to 1 Year|Only includes participants that completed the 1 year visit|Baseline to 1-year|Seven study eyes received 1 injection and 2 eyes received 2 injections of 0.5 mg of ranibizumab prior to the FDA approving a 0.3 mg dosage of ranibizumab for diabetic macular edema treatment.||Injections||Standard Deviation|Mean
676298|NCT01627249|Secondary|Overall Change in Retinal Volume|Baseline volume values were converted from the thickness value measured on a Spectralis or Cirrus OCT machine to a Stratus equivalent value for 459 scans. One-year volume values were converted from a thickness value measured on a Spectralis or Cirrus OCT machine to a Stratus equivalent value for 472 scans. When calculating change in volume, measurements taken on the same machine at both visits were not converted, because the conversion equation slope is nearly 1 and the constant difference does not affect the change calculation. Therefore, change in volume was calculated after converting either the baseline and/or follow-up value from Spectralis or Cirrus to a Stratus equivalent value in 17 eyes.|Baseline to 1-year|In addition to participants missing the 1-year visit, 46 in the aflibercept group, 53 in the bevacizumab group, and 44 in the ranibizumab group had 1-year visits but unusable OCT data to compute change due to the scan being missing or ungradable at either baseline or 1 year.||mm^3||Standard Deviation|Mean
676299|NCT01627249|Secondary|Change in Optical Coherence Tomography Central Subfield Thickness: Baseline Visual Acuity Letter Score 78-69|"All baseline and 1-year optical coherence tomography (OCT) scans were graded by Duke Reading Center. In addition, a random sample of OCT images from other visits and images for which the investigator believed central grading was needed also were graded by Duke Reading Center.
Baseline CSF values were converted from the thickness value measured on a Spectralis or Cirrus OCT machine to a Stratus equivalent value for 583 scans. One-year CSF values were converted from a thickness value measured on a Spectralis or Cirrus OCT machine to a Stratus equivalent value for 604 scans. When calculating change in CSF thickness, measurements taken on the same machine at both visits were not converted, since the conversion equation slope is nearly 1 and the constant difference does not affect the change calculation. Therefore, change in CSF thickness was calculated after converting either the baseline and/or follow-up thickness value from Spectralis or Cirrus to a Stratus equivalent value in 26 eyes."|baseline to 1-year|In addition to participants missing the 1-year visit, 3 in the aflibercept group, 3 in the bevacizumab group, and 5 in the ranibizumab group had 1-year visits but unusable OCT data to compute change due to the scan being missing or ungradable at either baseline or 1 year.||microns||Standard Deviation|Mean
676300|NCT01627249|Secondary|Change in Optical Coherence Tomography Central Subfield Thickness: Baseline Visual Acuity Letter Score <69|"All baseline and 1-year optical coherence tomography (OCT) scans were graded by Duke Reading Center. In addition, a random sample of OCT images from other visits and images for which the investigator believed central grading was needed also were graded by Duke Reading Center.
Baseline CSF values were converted from the thickness value measured on a Spectralis or Cirrus OCT machine to a Stratus equivalent value for 583 scans. One-year CSF values were converted from a thickness value measured on a Spectralis or Cirrus OCT machine to a Stratus equivalent value for 604 scans. When calculating change in CSF thickness, measurements taken on the same machine at both visits were not converted, since the conversion equation slope is nearly 1 and the constant difference does not affect the change calculation. Therefore, change in CSF thickness was calculated after converting either the baseline and/or follow-up thickness value from Spectralis or Cirrus to a Stratus equivalent value in 26 eyes."|baseline to 1-year|In addition to participants missing the 1-year visit, 3 in the aflibercept group, 3 in the bevacizumab group, and 5 in the ranibizumab group had 1-year visits but unusable OCT data to compute change due to the scan being missing or ungradable at either baseline or 1 year.||microns||Standard Deviation|Mean
676301|NCT01627249|Primary|Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 1-year: Baseline Visual Acuity Letter Score 78-69|Visual Acuity was measured with the Electronic Early Treatment Study (E-ETDRS) visual acuity test. Unit of measure is based on the E-ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.|Baseline to 1-year|Visual acuity change truncated to +/- 3SD (-22 and +44) to minimize the effects of outliers for 6 eyes in the aflibercept group (4 on the positive end, 2 on the negative end) and 2 eyes in the bevacizumab group (both on the negative end).||units on a scale||Standard Deviation|Mean
676302|NCT01627249|Primary|Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 1-year: Baseline Visual Acuity Letter Score <69|Visual Acuity was measured with the Electronic Early Treatment Study (E-ETDRS) visual acuity test. Unit of measure is based on the E-ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.|Baseline to 1-year|Visual acuity change truncated to +/- 3SD (-22 and +44) to minimize the effects of outliers for 6 eyes in the aflibercept group (4 on the positive end, 2 on the negative end) and 2 eyes in the bevacizumab group (both on the negative end).||units on a scale||Standard Deviation|Mean
676303|NCT01627249|Secondary|Overall Change in Optical Coherence Tomography Central Subfield Thickness|"All baseline and 1-year optical coherence tomography (OCT) scans were graded by Duke Reading Center. In addition, a random sample of OCT images from other visits and images for which the investigator believed central grading was needed also were graded by Duke Reading Center.
Baseline CSF values were converted from the thickness value measured on a Spectralis or Cirrus OCT machine to a Stratus equivalent value for 583 scans. One-year CSF values were converted from a thickness value measured on a Spectralis or Cirrus OCT machine to a Stratus equivalent value for 604 scans. When calculating change in CSF thickness, measurements taken on the same machine at both visits were not converted, since the conversion equation slope is nearly 1 and the constant difference does not affect the change calculation. Therefore, change in CSF thickness was calculated after converting either the baseline and/or follow-up thickness value from Spectralis or Cirrus to a Stratus equivalent value in 26 eyes."|baseline to 1-year|In addition to participants missing the 1-year visit, 3 in the aflibercept group, 3 in the bevacizumab group, and 5 in the ranibizumab group had 1-year visits but unusable OCT data to compute change due to the scan being missing or ungradable at either baseline or 1 year.||microns||Standard Deviation|Mean
676304|NCT01627249|Primary|Overall Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 1-year|Visual Acuity was measured with the Electronic Early Treatment Study (E-ETDRS) visual acuity test. Unit of measure is based on the E-ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.|Baseline to 1-year|Visual acuity change truncated to +/- 3SD (-22 and +44) to minimize the effects of outliers for 6 eyes in the aflibercept group (4 on the positive end, 2 on the negative end) and 2 eyes in the bevacizumab group (both on the negative end).||units on a scale||Standard Deviation|Mean
676305|NCT01627002|Secondary|Assessment of the Effect of PA401 on Induced Sputum Percentage Neutrophils|Induced sputum was collected 6 hours after lipopolysaccharide challenge (5.5 hours following dosing) and assessed for neutrophils|5.5 hours post dose|||percentage of total cells||95% Confidence Interval|Least Squares Mean
676313|NCT01626820|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|SAEs assessed included medical occurrences that resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|During the entire study period (Day 0 - Day 20 after vaccination).|Analysis was performed on the Total Vaccinated cohort which included all subjects with a documented vaccine administration.||Subjects|||Number
676314|NCT01626820|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 21-day (Days 0-20) post-vaccination period.|Analysis was performed on the Total Vaccinated cohort which included all subjects with a documented vaccine administration.||Subjects|||Number
676315|NCT01626820|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, sweating and fever [oral temperature ≥38.0 degrees Celsius (°C)]. Gastrointestinal symptoms included nausea, vomiting, diarrhea and/or abdominal pain. Any =occurrence of any specified solicited general symptoms reported irrespective of intensity grade or relationship to vaccination, Any fever = oral temperature ≥38.0 degrees Celsius (°C). Grade 3 symptoms = symptoms that prevented normal activities. Grade 3 fever = oral temperature ≥39.0°C. Related = symptoms considered by the investigator to have a causal relationship to vaccination|During the 4-day (Days 0-3) post-vaccination period|Analysis was performed on theTotal Vaccinated cohort which included all subjects with a documented vaccine administration and symptom sheet completed||Subjects|||Number
676316|NCT01626820|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.|Solicited local symptoms assessed were ecchymosis, induration, pain, redness and swelling. Any was defined as occurrence of any specified solicited local symptoms reported irrespective of intensity grade. Grade 3 pain was defined as considerable pain that prevented normal everyday activities. Grade 3 ecchymosis, induration, redness and swelling were defined as ecchymosis, induration, redness and swelling above 100 millimeters (mm).|During the 4-day (Days 0-3) post-vaccination period|Analysis was performed on the Total Vaccinated cohort which included all subjects with a documented vaccine administration and symptom sheet completed.||Subjects|||Number
676317|NCT01626820|Primary|Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the Three Vaccine Influenza Strains.|MGI was defined as the fold increase in serum HI GMTs post-vaccination (Day 21) compared to pre-vaccination (Day 0).|At Day 21|Analysis was performed on According To Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Fold increase||95% Confidence Interval|Mean
676318|NCT01626820|Primary|Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Influenza Strains.|A seroconverted subject was defined as a subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine influenza strains included Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2) and Flu B/Hubei-Wujiagang/158/09 (Yamagata) antigens.|At Day 21|Analysis was performed on According To Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
676319|NCT01626820|Primary|Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains.|A seroprotected subject was defined as a subject with serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The influenza vaccine strains included Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2) and Flu B/Hubei-Wujiagang/158/09 (Yamagata) antigens.|At Day 0 and Day 21|Analysis was performed on According To Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination||Subjects|||Number
676320|NCT01626820|Primary|Haemagglutination Inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains.|Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine influenza strains included Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2) and Flu B/Hubei-Wujiagang/158/09 (Yamagata) antigens.|At Day 0 and Day 21|Analysis was performed on According To Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Titer||95% Confidence Interval|Mean
676321|NCT01626690|Secondary|Temporal Artery Verus SpotOn (3M) Temperature Readings.|Temperature with temporal artery thermometer and SpotOn temperature monitoring device (3M) at time of incision.|The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).|||Degrees Celsius||Standard Deviation|Mean
676322|NCT01626690|Secondary|Incidence of Perioperative Cardiac Events.|Incidence of perioperative arrhythmias or myocardial ischemia.|The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).|||Patients|||Number
676323|NCT01626690|Secondary|Intraoperative Blood Loss.|Intraoperative blood loss in mL's.|The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).|||mL||Standard Deviation|Mean
676324|NCT01626690|Secondary|Incidence of Postoperative Shivering in Recovery Room.||The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).|||Number of patients reporting shivering|||Number
676325|NCT01626690|Secondary|Patient Temperature on Arrival to Recovery Room as Measured by SpotOn (3M) Temperature Monitoring System.||The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).|||Degrees Celsius||Standard Deviation|Mean
676326|NCT01626690|Secondary|Patient Temperature 30 Minutes Following Incision as Measured by SpotOn (3M) Temperature Monitoring System.||The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).|||Degrees Celsius||Standard Deviation|Mean
676327|NCT01626690|Secondary|Patient Temperature Prior to Entering OR as Measured by SpotOn (3M) Temperature Monitoring System.||The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).|||Degrees Celsius||Standard Deviation|Mean
676328|NCT01626690|Primary|Patient Temperature at the Time of Incision as Measured by SpotOn (3M) Temperature Monitoring System..|Temporal artery temperature readings (in degrees celsius) will be obtained at the time of incision and every 30 minutes while in the OR.|The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).|||Degrees Celsius||Standard Deviation|Mean
676329|NCT01626456|Secondary|Mean Change From Baseline to Endpoint Using the Positive and Negative Symptom Scale (PANSS) Total Score and Subscale Scores|This scale consists of symptom constructs (7 positive, 7 negative, 16 general psychopathology), each to be rated on a 7-point Likert-type scale of severity with 1 being absent to 7 being extreme. Minimum scores (best outcome) equals 30 (total scale), 7 (positive/negative subscales), and 16 (general subscale); maximum scores (worst outcome) equals 210 (total scale), 49 (positive/negative subscales), and 112 (general subscale).|52 weeks|The full analysis set consisted of all subjects who received at least 1 dose of ALKS 9072 and had at least 1 postbaseline assessment of PANSS total score after administration of ALKS 9072.||units on a scale||Standard Deviation|Mean
676330|NCT01626456|Secondary|Incidence of Clinically Significant Changes Will be Calculated for Movement Disorders, Vital Signs and Routine Laboratory Tests|Includes incidence >2% but <5%.|52 weeks|||participants|||Number
676331|NCT01626456|Secondary|Suicidal Ideation and Behavior Using the Columbia Suicide Severity Rating Scale (C-SSRS)|The C-SSRS is a questionnaire used for suicide assessment. Subjects are asked a series of questions that determine whether or not the patient demonstrates any suicidal ideation or behavior. The C-SSRS was administered to subjects at each study visit.|52 weeks|Safety population includes all subjects who received at least 1 dose of ALKS 9072 in the current study.||participants|||Number
676332|NCT01626456|Secondary|Discontinuation From Study Due to Adverse Events (AEs)|Number of subjects who discontinued the study due to AE.|52 weeks|Safety population includes all subjects who received at least 1 dose of ALKS 9072 in the current study.||participants|||Number
676333|NCT01626456|Secondary|Mean Change From Baseline to Endpoint in Clinical Global Impression Scale for Severity (CGI-S)|"The CGI-S is a 7-point scale that requires the clinician to assess how mentally ill the patient is in a specific point in time. Results indicate participants evaluated at one of the following categories: 1: normal, not at all ill; 2: borderline mentally ill; 3: mildly ill; 4: moderately ill; 5: markedly ill; 6: severely ill; and 7: among the most extremely ill patients. Results indicate a change in CGI-S score from baseline to Day 365 based on the observed data."|52 weeks|The full analysis set consists of all subjects who received at least 1 dose of ALKS 9072 and had at least 1 postbaseline assessment of PANSS score after administration of ALKS 9072.||units on a scale||Standard Deviation|Mean
676334|NCT01626456|Primary|Number of Subjects With Treatment-emergent Adverse Events (TEAEs)|This measure includes incidences >5%.|52 weeks|Safety population includes all subjects who receive at least 1 dose of ALKS 9072 in the current study.||participants|||Number
676335|NCT01626391|Primary|Safety and Tolerability of TRx0237 When Coadministered With an Acetylcholinesterase Inhibitor (AChEI) and/or Memantine|This was assessed by the number of participants who experienced adverse events within each treatment group (TRx0237 versus placebo) during 8 weeks of treatment.|8 weeks|Safety Population||participants|||Number
676336|NCT01626118|Secondary|TOTPAR-48. Total Pain Relief (TOTPAR) Over 0 to 48 Hours|"Pain relief was assessed with a 5-point categorical scale at all assessment timepoints after time 0. Subjects were asked “How much relief have you had since your starting pain?” with response choices of none=0, a little=1, some=2, a lot=3 and complete=4. Pain relief is assessed at the following points after time 0: 15, 30 & 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 32, 40 & 48 hours.
The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. Thus, individual scores covering a longer period were given more weight. The minimum theoretical score is 0 units, which represents no pain relief (0 on scale) at all points after time 0. The maximum theoretical score is 192 units, which represents complete pain relief (4 on scale) at all points after 0."|0-48 hours|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug.||units on a scale*hour||Standard Deviation|Mean
676337|NCT01626118|Secondary|TOTPAR-24. Total Pain Relief (TOTPAR) Over 0 to 24 Hours|"Pain relief was assessed with a 5-point categorical scale at all assessment timepoints after time 0. Subjects were asked “How much relief have you had since your starting pain?” with response choices of none=0, a little=1, some=2, a lot=3 and complete=4. Pain relief is assessed at the following points after time 0: 15, 30 & 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, & 24 hours.
The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. Thus, individual scores covering a longer period were given more weight. The minimum theoretical score is 0 units, which represents no pain relief (0 on scale) at all points after time 0. The maximum theoretical score is 96 units, which represents complete pain relief (4 on scale) at all points after 0."|0-24 hours|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug.||units on a scale*hour||Standard Deviation|Mean
676376|NCT01625507|Primary|Change in Total Energy Intake|Measured using repeated 24 hour dietary recalls (pre and post-intervention)|4 months|All participants, intention to treat protocol||kcal||95% Confidence Interval|Mean
676338|NCT01626118|Secondary|TOTPAR-8. Total Pain Relief (TOTPAR) Over 0 to 8 Hours|"Pain relief was assessed with a 5-point categorical scale at all assessment timepoints after time 0. Subjects were asked “How much relief have you had since your starting pain?” with response choices of none=0, a little=1, some=2, a lot=3 and complete=4. Pain relief is assessed at the following points after time 0: 15, 30 & 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7 & 8 hours.
The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. Thus, individual scores covering a longer period were given more weight. The minimum theoretical score is 0 units, which represents no pain relief (0 on scale) at all points after time 0. The maximum theoretical score is 32 units, which represents complete pain relief (4 on scale) at all points after 0."|0-8 hours|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug.||units on a scale*hour||Standard Deviation|Mean
676339|NCT01626118|Secondary|Total Pain Relief (TOTPAR) Over 0 to 4 Hours (TOTPAR-4).|"Pain relief was assessed with a 5-point categorical scale at all assessment timepoints after time 0. Subjects were asked “How much relief have you had since your starting pain?” with response choices of none=0, a little=1, some=2, a lot=3 and complete=4. Pain relief is assessed at the following points after time 0: 15, 30 & 45 minutes and 1, 1.5, 2, 3 & 4 hours.
The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. Thus, individual scores covering a longer period were given more weight. The minimum theoretical score is 0 units, which represents no pain relief (0 on scale) at all points after time 0. The maximum theoretical score is 16 units, which represents complete pain relief (4 on scale) at all points after 0."|0-4 hours|||units on a scale*hour||Standard Deviation|Mean
676340|NCT01626118|Secondary|VASSPID-24. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 24 Hours After Trial Entry.|"The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing No Pain and 100 mm representing Worst Possible Pain. Pain intensity is assessed at baseline (time “0”) and at the following time points after time 0: 15, 30, and 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, and 24 hours.
The VAS summed pain intensity difference (VASSPID) is calculated as a time-weighted sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment."|0-24 hours|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug.||mm*hour||Standard Deviation|Mean
676341|NCT01626118|Secondary|VASSPID-8. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 8 Hours After Trial Entry.|"The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing No Pain and 100 mm representing Worst Possible Pain. Pain intensity is assessed at baseline (time “0”) and at the following time points after time 0: 15, 30, and 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 hours.
The VAS summed pain intensity difference (VASSPID) is calculated as the sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment."|0-8 hours|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug.||mm*hour||Standard Deviation|Mean
676342|NCT01626118|Secondary|VASSPID-4. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 4 Hours After Trial Entry.|"The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing No Pain and 100 mm representing Worst Possible Pain. Pain intensity is assessed at baseline (time “0”) and at the following time points after time 0: 15, 30, and 45 minutes and 1, 1.5, 2, 3, and 4 hours.
The VAS summed pain intensity difference (VASSPID) is calculated as the sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment."|0-4 hours|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug.||mm*hour||Standard Deviation|Mean
676343|NCT01626118|Primary|The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale From 0 to 48 Hours After Trial Entry (VASSPID-48)|"The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing No Pain and 100 mm representing Worst Possible Pain. Pain intensity is assessed at baseline (time “0”) and at the following time points after time 0: 15, 30, and 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 32, 40, and 48 hours.
The VAS summed pain intensity difference (VASSPID) is calculated as the sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment."|0-48 hours|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug.||mm*hour||Standard Deviation|Mean
676344|NCT01626092|Secondary|Neurologic Outcomes|Depending upon underlying primary disease, a combination of evaluative tools (e.g. brain magnetic resonance imaging (MRI), clinical neurologic exam, neuropsychologic testing, electromyography) will be applied for assessment of neurologic function and how it may be affected by this reduced-intensity HCT regimen.|Changes from Baseline, Days 30, 60, 100, Year 1, Year 2, Year 3 Following HCT|None of the 3 patients enrolled in the study were evaluable for this outcome. Two had a repeat transplant and one was lost to follow-up.|||||
676345|NCT01626092|Secondary|Transplant-Related Mortality|Incidence of death due to complications of HCT following this reduced-intensity conditioning regimen.|Day 100 following HCT|||participants|||Number
676346|NCT01626092|Primary|Donor (Allogeneic) Hematopoietic Engraftment|Number of patients who achieve hematopoietic engraftment - assessment of nucleated peripheral blood cells for donor (allogeneic) chimerism following this reduced-intensity HCT.|Day 100 Following Hematopoietic Cell Transplant (HCT)|||participants|||Number
676348|NCT01625910|Primary|Body Mass Index Z-score Change|Change in body mass index z-score change over the three month time period|Three months|All enrolled were analyzed with one exception (due to injury and prolonged cast treatment). An intent-to-treat analysis required that, for those who did not have the follow-up measurement, data were filled in using the experience of those in the control group who had follow-up measurements.||BMI z-score change||Standard Error|Mean
676349|NCT01625845|Secondary|Change in Circulating C-Reactive Protein (CRP) From Pre- to Post-Treatment|A marker of systemic inflammation measured from blood samples collected at pre- and post-treatment.|0 and 12 weeks|||mg/L||Standard Error|Mean
676350|NCT01625845|Secondary|Change in Interleukin-1ra (IL-1ra) From Pre- to Post-Treatment|A marker of systemic inflammation measured from blood samples collected at pre- and post-treatment.|0 and 12 weeks|||pg/mL||Standard Error|Mean
676351|NCT01625845|Secondary|Change in Circulating Interleukin-10 (IL-10) From Pre- to Post-Treatment|An anti-inflammatory cytokine measured from blood samples collected at pre- and post-treatment.|0 and 12 weeks|One participant, with extreme outlier values at pre- and post-treatment, was excluded from analyses.||pg/mL||Standard Error|Mean
676352|NCT01625845|Secondary|Change in Circulating Interleukin-6 (IL-6) From Pre- to Post-Treatment|A marker of systemic inflammation measured from blood samples collected at pre- and post-treatment.|0 and 12 weeks|||pg/mL||Standard Error|Mean
676353|NCT01625845|Secondary|Change in Circulating Tumor Necrosis Factor-Alpha (TNF-a) From Pre- to Post-Treatment|A marker of systemic inflammation measured from blood samples collected at pre- and post-treatment.|0 and12 weeks|Participants with missing TNF-a data were excluded from this analysis.||pg/mL||Standard Error|Mean
676354|NCT01625845|Primary|Change in Depressive Symptoms Severity (Hopkins Symptom Checklist Depression Scale; SCL-20) From Pre- to Post- Treatment|Self-reported depressive symptom severity was measured at pre- (0 weeks) and post- (12 weeks) treatment visits by the 20 depression items from the Symptom Checklist 90 (Hopkins Symptom Checklist depression scale; SCL-20). Each item on the scale ranges from 0 (not at all) to 4 (extremely). Total scores are the average across all response items and range from 0 to 4 with higher scores indicating greater levels of depressive symptoms.|0 and 12 weeks|||Change in Total Score||Standard Error|Mean
676355|NCT01625845|Primary|Change in Brachial Flow-Mediated Dilation (FMD) From Pre- to Post- Treatment|Patients underwent ultrasound assessment of brachial FMD in accordance with established guidelines at pre- (0 weeks) and post- (12 weeks) treatment. After a 10-minute supine rest, high-resolution baseline images of the brachial artery were obtained from 3 consecutive cardiac cycles. Next, the forearm cuff was inflated to 250 mmHg for 5 minutes and then was rapidly deflated. At 60 and 90 seconds post-deflation, images from 3 consecutive cardiac cycles were acquired. FMD values were computed as the % change in brachial diameter at either 60 or 90 seconds after cuff deflation|0 and 12 weeks|||% change in brachial diameter||Standard Error|Mean
676356|NCT01625689|Secondary|Viral Etiologies of Acute Respiratory and Febrile Illness Will be Parameterized as the Percentage of Those With Each Particular Laboratory-confirmed Respiratory Virus Infection Categorized by Vaccine Allocation||6 months post-vaccination||||||
676357|NCT01625689|Secondary|Clinical Characteristics of Influenza, Including Influenza Coinfections With Other Bacterial and Viral Respiratory Pathogens, Will be Parameterized as the Percentage of Participants Categorized by Vaccine Allocation||6 months post-vaccination||||||
676358|NCT01625689|Secondary|Post Vaccination SIIL LAIV Virus Shedding/Vaccine-take Will be Parameterized by the Percentage of Participants With Detectable Virus by Post Vaccination Day.||2, 4, and 7 days post-vaccination||||||
676359|NCT01625689|Secondary|The Post-vaccination Anti-influenza Immunologic Response Will be Measured Based on the Type of Immunologic Assay and Categorized by Vaccine Virus Strain, Participant Baseline Serostatus, and Vaccine Allocation||Approximately 21 days post-vaccination||||||
676360|NCT01625689|Primary|Percentage of Participants With Solicited Local and Systemic Reactions|"Local reactions: Nasal discomfort, Runny nose, Stuffy nose, Sneezing, Ear pain
Systemic Reactions: Cough, Headache, Loss of Appetite, Fever, Irritability, Nausea, Sore throat, Lethargy"|Through 7 days following vaccination|Safety analysis population||percentage of participants|||Number
676361|NCT01625689|Primary|Percentage of Participants With Unsolicited Adverse Events (AEs)||Throughout study period, through at least 6 months following vaccination|||percentage of participants|||Number
676362|NCT01625689|Primary|Number of Participants With Serious Adverse Events (SAEs), All-cause Hospitalizations, and Protocol-defined Wheezing Illness (PDWI) Episodes|"PDWI: Participants meeting illness criteria, seeking care in health facility, and with wheeze identified by a study physician
Illness criteria: The presence of one Category A (Fever (>=38°C), tachypnea, danger signs (chest-indrawing, lethargy, cyanosis, inability to drink, convulsions), difficult breathing, noisy breathing, ear pain or discharge) or two Category B findings (Cough, rhinorrhea, sore throat, myalgia/arthralgia, chills, headache, irritability/decreased activity, vomiting)
Wheeze: Long high-pitched whistling or musical sound on expiration heard by auscultation"|42 days following vaccination||||||
676363|NCT01625689|Primary|Number of Participants With Serious Adverse Events (SAEs), All-cause Hospitalizations, and Protocol-defined Wheezing Illness (PDWI) Episodes|"PDWI: Participants meeting illness criteria, seeking care in health facility, and with wheeze identified by a study physician
Illness criteria: The presence of one Category A (Fever (>=38°C), tachypnea, danger signs (chest-indrawing, lethargy, cyanosis, inability to drink, convulsions), difficult breathing, noisy breathing, ear pain or discharge) or two Category B findings (Cough, rhinorrhea, sore throat, myalgia/arthralgia, chills, headache, irritability/decreased activity, vomiting)
Wheeze: Long high-pitched whistling or musical sound on expiration heard by auscultation"|6 months following vaccination|Safety analysis population||participants|||Number
676364|NCT01625507|Secondary|Change in Waist Circumference|Measured using repeated 24 hour dietary recalls (pre and post-intervention|4 months|||cm||95% Confidence Interval|Mean
676365|NCT01625507|Secondary|Food Availability|questionnaire of items related to the availability in local stores of the food items recommended in the diet for diabetes.|4 months||||||
676366|NCT01625507|Secondary|Food Accessibility|questionnaire of items related to financial and physical accessibility of foods in the diet recommended for diabetes|4 months||||||
676367|NCT01625507|Secondary|Food Acceptability|questionnaire based on items related to personal and cultural acceptability of the recommended diet|4 months||||||
678091|NCT01601821|Secondary|Number of Participants Who Discontinued|Number of participants who discontinued the study treatment due to any reason is reported.|Month 12|Analysis population included all participants enrolled in the study.||participants|||Number
676377|NCT01625455|Secondary|Quality of Life|"The secondary endpoint is the quality of life as measured on the Dermatology Quality of Life Index (DLQI).
For a series of 10 questions the responses are scored: Very much, scored 3; A lot, scored 2; A little, scored 1; Not at all, scored 0; Not relevant, scored 0; and Question unanswered, scored 0. The scores are summed and the larger the score the greater the effect of the dermatological disease impact on quality of life.
Maximum response for all ten questions 30, minimum 0."|one week|||scores on a scale||Standard Deviation|Mean
676378|NCT01625455|Primary|Severity of Pruritus|The primary endpoint is the severity of pruritus as measured on the visual analogue scale. A score of 100 indicated the worst pruritus imaginable, while 0 indicated no pruritus.|one week|||units on a scale||Standard Deviation|Mean
676379|NCT01625377|Secondary|Number of Patients With Any Adverse Events, Serious Adverse Events, Death and Premature Discontinuation|Baseline was Day 28 visit. This endpoint reports patients with total adverse events (any), serious adverse events, death and premature discontinuation.|Baseline to 24 weeks|The safety population included all randomized patients who received at least one dose of study treatment post-randomization and for whom there was a post-treatment safety assessment.||Patients|||Number
676380|NCT01625377|Secondary|Number of Patients in Different Stages of Chronic Kidney Diseases According to the K/DOQI Classification System|"Kidney disease outcomes quality initiative (K/DOQI) classification is based on glomerular filtration rate (GFR), abbreviated MDRD formula (mL/min/1.73m^2) :
Stage 1 : GFR >= 90; Stage 2 = GFR was between 60-89; Stage 3 = GFR was between 30-59 ; Stage 4 = GFR was between 15-29; Stage 5 = GFR was < 15 (or dialysis)"|At Week 24|ITT population included all randomized patients who received at least one dose of study treatment post-randomization and for whom a creatinine value at D28 and a posterior value were available.||Patients|||Number
676381|NCT01625377|Secondary|Change From Baseline (Randomization) in Glomerular Filtration Rate Estimated by CKD-EPI Formula|"GFR estimated by using the Chronic kidney disease- epidemiology (CKD-EPI) formula:
eGFR (mL/min/1.73m^2) = 141 * min(C/K,1)^ α * max(C/K,1)^-1.209 * 0.993^A * 1.1018 (if male) * 1.159 (if black) where C = serum creatinine (in mg/dL) ; A = Age (in years); K = 0.7 for women and 0.9 for men; α = -0.329 for women and -0.411 for men. Baseline was Day 28 visit."|Baseline, Week 24|The Intent to treat (ITT) population included all randomized patients who received at least one dose of study treatment post-randomization and for whom a creatinine value at D28 and a posterior value were available. The last observation carried forward (LOCF) is used as imputation of missing data.||mL/min/1.73m^2||Standard Deviation|Mean
676382|NCT01625377|Secondary|Change From Baseline (Randomization) in Glomerular Filtration Rate Estimated by Abbreviated Modification of Diet in Renal Disease (MDRD) Formula|"Change in glomerular filtration rate was calculated using the MDRD abbreviated formula.
GFR in mL/min/1.73m^2 for men of non-black ethnicity: 186 * [C/88]^-1.154 * [A]^-0.023*G*R ; C = serum creatinine (in μmol/L); A = Age (in years). G = 0.742 when the patient is a women; Otherwise G=1 R= 1.21 when the patient was of black ethnicity; Otherwise R = 1 Baseline was Day 28 visit."|Baseline, Week 24|The Intent to treat (ITT) population included all randomized patients who received at least one dose of study treatment post-randomization and for whom a creatinine value at D28 and a posterior value were available. The last observation carried forward (LOCF) is used as imputation of missing data.||mL/min/1.73m^2||Standard Deviation|Mean
676383|NCT01625377|Secondary|Change From Baseline (Randomization) in Creatinine Clearance Estimated Using the Adjusted Cockcroft-Gault Formula|Creatinine clearance by the Cockcroft-Gault formula is computed in mL/min/1.73m^2 from the creatinine clearance in mL/min by multiplying it by 1.73 and dividing it by the body surface area Baseline was Day 28 visit.|Baseline, Week 24|The Intent to treat (ITT) population included all randomized patients who received at least one dose of study treatment post-randomization and for whom a creatinine value at D28 and a posterior value were available. The last observation carried forward (LOCF) is used as imputation of missing data.||mL/min/1.73m^2||Standard Deviation|Mean
676384|NCT01625377|Secondary|Change From Baseline (Randomization) in Urine Protein/Creatinine Ratio|Change in urine protein/creatinine ratio from baseline (randomization) to week 24 post-randomization was one of the efficacy assessments of renal function. Baseline was Day 28 visit.|Baseline, week 24|The Intent to treat (ITT) population included all randomized patients who received at least one dose of study treatment post-randomization and for whom urine protein and creatinine value at day 28 and a posterior value were available. LOCF applied.||mg/mmol||Standard Deviation|Mean
676385|NCT01625377|Secondary|Change From Baseline (Randomization) in Serum Creatinine|"Change in serum creatinine concentrations from baseline (randomization) to week 24 post-randomization was one of the efficacy assessments of renal function.
Baseline was Day 28 visit."|Baseline, Week 24|The Intent to treat (ITT) population included all randomized patients who received at least one dose of study treatment post-randomization and for whom a creatinine value at D28 and a posterior value were available. The last observation carried forward (LOCF) is used as imputation of missing data.||µmol/L||Standard Deviation|Mean
676386|NCT01625377|Secondary|Number of Patients With Death or Graft Loss|The graft was presumed to be lost on the day the patient was registered again on the waiting list, or the day he/she received a new graft.|at week 24|The Intent to treat (ITT) population included all randomized patients who received at least one dose of study treatment post-randomization and for whom a creatinine value at day 28 and a posterior value were available.||Patients|||Number
676387|NCT01625377|Secondary|Number of Patients With Treated or Untreated BPAR With RAI Score Greater Than 3|"Biopsy proven acute rejection (BPAR) was defined as a clinically suspected acute rejection confirmed by biopsy. The Banff Rejection Activity Index (RAI) comprises 3 components scored from 0 to 3: venous endothelial inflammation; bile duct inflammation damage; and portal inflammation; the scores are combined to an overall score (the RAI) ranging from 0 to 9. An overall score of 0-3 is considered indeterminate, score of 4-5 is mild acute, score of 6-7 is moderate acute , and score of 8-9 is severe acute. Only the episode with the highest total RAI score for each participant was counted.
The patients with treated or untreated BPAR having RAI score > 3 were reported in this end point."|At 24 weeks|The Intent to treat (ITT) population included all randomized patients who received at least one dose of study treatment post-randomization and for whom a creatinine value at day 28 and a posterior value were available.||Patients|||Number
676422|NCT01624948|Primary|Evidence of Reduction of BK Viruria and/or Clearance of BK Viremia|composite outcome of a 50% or greater reduction in BKV urine levels and/or complete clearance of BKV viremia by 3 months after randomization|3 months post-randomization|||participants|||Number
676388|NCT01625377|Secondary|Number of Patients Reported With Different Categories of Severity of BPAR According to Banff Classification|"Biopsy proven acute rejection was defined as a clinically suspected acute rejection confirmed by biopsy.
The severity of BPAR was categorized as :
Mild (Banff grade I, RAI = 4 and 5) Moderate (Banff grade II, RAI = 6 and 7) Severe (Banff grade III, RAI = 8 and 9) Banff Rejection Activity Index (RAI) comprises 3 components scored from 0 to 3: venous endothelial inflammation; bile duct inflammation damage; and portal inflammation; the scores are combined to an overall score (the RAI) ranging from 0 to 9. An overall score of 0-3 is considered indeterminate, score of 4-5 is mild acute, score of 6-7 is moderate acute , and score of 8-9 is severe acute. Only the episode with the highest total RAI score for each participant was counted."|at 12 week and 24 week|The Intent to treat (ITT) population included all randomized patients who received at least one dose of study treatment post-randomization and for whom a creatinine value at day 28 and a posterior value were available.||Patients|||Number
676389|NCT01625377|Secondary|Number of Patients With Treated or Not Treated Biopsy Proven Acute Rejection (BPAR)|Biopsy proven acute rejection was defined as a clinically suspected acute rejection confirmed by biopsy.|at 12 week and 24 week|The Intent to treat (ITT) population included all randomized patients who received at least one dose of study treatment post-randomization and for whom a creatinine value at Day 28 and a posterior value were available.||Patients|||Number
676390|NCT01625377|Secondary|Number of Patients With Treatment Failures|"Incidence of treatment failures, assessed with composite criterion including treated biopsy proven acute rejection (tBPAR) with a rejection activity index (RAI) according to Banff classification >3, graft loss or death at 6 months.
Biopsy proven acute rejection (BPAR) was defined as a clinically suspected acute rejection confirmed by biopsy. The Banff Rejection Activity Index (RAI) comprises 3 components scored from 0 to 3: venous endothelial inflammation; bile duct inflammation damage; and portal inflammation; the scores are combined to an overall score (the RAI) ranging from 0 to 9. An overall score of 0-3 is considered indeterminate, score of 4-5 is mild acute, score of 6-7 is moderate acute , and score of 8-9 is severe acute. Only the episode with the highest total RAI score for each participant was counted.
The graft was presumed to be lost on the day the patient was registered again on the waiting list, or the day he/she received a new graft."|At week 12 and week 24|The Intent to treat (ITT) population included all randomized patients who received at least one dose of study treatment post-randomization and for whom a creatinine value at Day 28 and a posterior value were available.||Patients|||Number
676391|NCT01625377|Primary|Change From Baseline (Randomization) in Renal Function|"Change in renal function was measured by change in glomerular filtration rate (GFR). GFR calculated using the abbreviated modification of diet in renal disease (aMDRD) formula.
GFR in mL/min/1.73m^2 for men of non-black ethnicity: 186 * [C/88]^-1.154 * [A]^-0.023*G*R ; C = serum creatinine (in μmol/L); A = Age (in years). G = 0.742 when the patient is a women; Otherwise G=1 R= 1.21 when the patient was of black ethnicity; Otherwise R = 1 Baseline was Day 28 visit."|Baseline, Week 24|The Intent to treat (ITT) population included all randomized patients who received at least one dose of study treatment post-randomization and for whom a creatinine value a Day 28 and a posterior value were available. The last observation carried forward (LOCF) is used as imputation of missing data.||mL/min/1.73m^2||Standard Error|Least Squares Mean
676392|NCT01625338|Secondary|Percentage of Participants With Viral Relapse|Viral relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement.|Up to Posttreatment Week 24|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants|||Number
676393|NCT01625338|Secondary|Percentage of Participants With On-treatment Virologic Failure|"On-treatment virologic failure was defined as
Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)"|Up to 24 weeks|Full Analysis Set||percentage of participants|||Number
676394|NCT01625338|Secondary|Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set||percentage of participants|||Number
676395|NCT01625338|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 24 weeks|Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.||percentage of participants|||Number
676396|NCT01625338|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants who were enrolled and received at least 1 dose of study drug.||percentage of participants|||Number
676397|NCT01625221|Primary|Reduction in Fecal Incontinence Symptoms|Effectiveness will be characterized as the reduction of FI symptoms by subjective measurements using the FISI, Wexner, and FIQOL scores and a three week diary documenting episodes of incontinence.|12 Months|||episodes per week||Standard Deviation|Mean
676398|NCT01625221|Primary|Serious Adverse Events|The safety objective will be met via reporting all adverse events at various time points including implant, 6 weeks, 3 months, 6 months, and 12 months (and then semi-annually until 5 years post-implant at U.S. sites). Serious device- and procedure-related adverse events will be summarized separately. Safety will be characterized by physical examination and pelvic X-ray evaluations.|12 months||||||
676403|NCT01625169|Secondary|HIV Viral Load in Breast Milk and Plasma|Positive HIV RNA in breast milk and plasma- LDL 40 copies/ml|Day 14|One participant did not complete D14 visit.||participants|||Number
676404|NCT01625169|Secondary|HIV Viral Load in Breast Milk and Plasma|Positive HIV RNA in breast milk and plasma- LDL 40 copies/ml|Day 5|One participant did not complete Visit D5.||participants|||Number
676405|NCT01625169|Primary|Area Under the Curve (AUC) 0-12 for Breast Milk|AUC 0-12 ng*hr/ml|Day 14|One participant did not complete D14 visit.||ng*hr/ml||Standard Deviation|Mean
676406|NCT01625169|Primary|Area Under the Curve (AUC) 0-12 for Breast Milk|AUC 0-12 ng*hr/ml|Day 5|One participant did not complete D5 visit.||ng*hr/ml||Standard Deviation|Mean
676407|NCT01625169|Primary|Area Under the Curve (AUC) 0-12 for Plasma|AUC 0-12 ng*hr/ml|Day 14: 0, 2,4, 8 and 24 hours post dose|One participant did not complete D14 visit.||ng*hr/ml||Standard Deviation|Mean
676408|NCT01625169|Primary|Area Under the Curve (AUC) 0-12 for Plasma|AUC 0-12 ng*hr/ml|Day 5: 0, 2,4, 8 and 24 hours post dose|One participant did not complete Day 5 visit.||ng*hr/ml||Standard Deviation|Mean
676409|NCT01625169|Primary|Peak Plasma Concentration of Etravirine in Plasma|Cmax ng/mL|day 14|Note: One participant did not complete the Day 14 evaluation.||ng/ml||Standard Deviation|Mean
676410|NCT01625169|Primary|Peak Concentration of Etravirine in Breast Milk|Cmax ng/mL|day 14|Note: One participant did not complete the Day 14 evaluation.||ng/ml||Standard Deviation|Mean
676411|NCT01625169|Primary|Peak Concentration of Etravirine in Breast Milk|"Cmax ng/ml
Note: One participant did not complete the Day 5 evaluation."|day 5|Note: One participant did not complete the Day 5 evaluation.||ng/ml||Standard Deviation|Mean
676412|NCT01625169|Primary|Peak Plasma Concentration of Etravirine in Plasma|"Cmax ng/ml
Note: One participant did not complete the Day 5 evaluation."|Day 5|Note: One participant did not complete the Day 5 evaluation.||ng/ml||Standard Deviation|Mean
676413|NCT01625091|Secondary|Craving for Alcohol|Self-reported scale of alcohol craving ranging from 0 (no craving) to 10 (strongest craving)|4 months|||units on a scale||Standard Deviation|Mean
676414|NCT01625091|Secondary|SIP-2R Score|The sum total score of Short Inventory of Problems (SIP-2R). SIP-2R has 15 items asking how often the event happened during the past 3 months. Each item has a score from 0-3 (0=Never, 1=once or a few times, 2=once or twice a week, 3=daily or almost daily).|4 months|||units on a scale||Standard Deviation|Mean
676415|NCT01625091|Secondary|Number of Binge Drinking Days|In the past 30 days, total number of days with binge drinking which was defined as consuming ≥4 drinks on a single day (measured by Timeline Follow Back).|Month 4|||Days||95% Confidence Interval|Median
676416|NCT01625091|Primary|Quit Hazardous Drinking|The primary statistical outcome for the trial is alcohol consumption at month 4 when the drug is stopped. Quit hazardous drinking is defined as ≤7 drinks per week and <4 drinks on any single day in the past 30 days.|Month 4|||Participants|||Count of Participants
676417|NCT01624948|Secondary|Median Between the Calculated Mean Residual Expression of NFAT-regulated Genes|"Measurement of the expression of three NFAT-regulated genes IL-2, interferon gamma, and GM-CSF, to predict a rejection episode.
The residual gene expression after Tacrolimus intake was calculated as T1.5/T0*100, where T0 is the adjusted number of transcripts at Tacrolimus pre-dose level and T1.5 is the number of transcripts 1.5 hours after drug intake. For all three genes the residual expression was averaged and presented as “MRE of NFAT-regulated genes.”"|3 months post-randomization|a subset of 19 participants enrolled in the immune-monitoring portion of the study||percent residual expression||95% Confidence Interval|Median
676418|NCT01624948|Secondary|Proteinuria||3 months post-randomization|||g/g creatinine||Standard Deviation|Mean
676419|NCT01624948|Secondary|Cholesterol||3 months post-randomization|||mg/dL||Standard Deviation|Mean
676420|NCT01624948|Secondary|p70S6 Kinase Phosphorylation||3 months post-randomization|19 patients enrolled in the immune-monitoring subset; 1 participant did not have a 3-month assay.||Mean Fluorescence Intensity||95% Confidence Interval|Median
676421|NCT01624948|Secondary|Evaluation for the Development of BK Virus Nephropathy or Doubling of BK Viremia Levels|A doubling of BK viremia levels or the development of BKV nephropathy in subjects enrolled in the experimental study arm will prompt a conversion to standard care therapy. We will closely monitor BKV levels in the urine and blood and assess renal function monthly, as per our usual standard of care. Based on BKV results as well as renal function, as assessed by serum Cr, biopsies may be done for cause. Patients will have a final visit at month 4 to monitor for adverse events.|3 months post-randomization|||participants|||Number
676423|NCT01624740|Primary|Change in Back Pain Intensity|"Back pain intensity was measured on a 0-10 numerical rating scale (0=no pain, 10=worst pain imaginable) at baseline and following low rate and high rate stimulation. This outcome measure compared the change in intensity from baseline between low rate and high rate stimulation."|For this measure, outcome was assessed at baseline, the end of the first intervention (3 or 4 days post-implantation, depending on the subject), and the end of the second intervention (6 or 8 days post-implantation, depending on the subject).|||Percent Change From Baseline||Standard Deviation|Mean
676424|NCT01624467|Secondary|Number of Participants With an Incidence of Anti-Necitumumab Antibodies||Baseline to Post Infusion 30 Day Follow-up|All participants who received at least 1 dose of study drug and had at least 1 post-infusion blood sample.||participants|||Number
676425|NCT01624467|Secondary|Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR]) (Tumor Response Rate Per Response Evaluation Criteria in Solid Tumors Version 1.1 [RECIST 1.1])|ORR is confirmed best overall tumor response of CR or PR. According to RECIST v1.1,CR was defined as the disappearance of all target and non-target lesions. Percentage of participants was calculated as: (total number of participants with CR or PR from start of the treatment until disease progression or recurrence)/total number of participants treated) * 100. PR defined as a >30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD.|Baseline to Measured Progressive Disease (up to 21 Months)|All participants who received any study drug and had CR or PR.||percentage of participants||95% Confidence Interval|Number
676426|NCT01624467|Secondary|Pharmacokinetics: Maximum Drug Concentration (Cmax) of Necitumumab||Cycle 1 (Days 1 and 36); Pre-infusion, 50 minutes, 1.5, 2.5, 4.5, 24, 28, 72, and 168 hours|All participants who received at least one dose of study drug and had evaluable PK parameters in Cycle 1, Days 1 and 36.||microgram/milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
676427|NCT01624467|Secondary|Pharmacokinetics (PK): Area Under the Concentration-Time Curve of Necitumumab From Zero to Infinity (AUC[0-∞])||Cycle1 (Days 1 and 36): Pre-infusion, 50 minutes, 1.5, 2.5, 4.5, 24, 28, 72, and 168 hours|All participants who received at least one dose of study drug and had evaluable PK parameters in Cycle 1 on Days 1 and 36.||microgram*hour/milliliter (μg*h/ml)||Geometric Coefficient of Variation|Geometric Mean
676428|NCT01624467|Secondary|Change From Time-Matched Baseline in Heart Rate (HR) (Electrocardiographic Parameters: Heart Rate [HR])|Change in HR from time-matched measures performed at baseline.|Baseline, Cycle1 Day 36: Pre-infusion, End of Infusion, 1 Hour (hr), 2, 4, 24, 48, 72 hr Post Infusion|QTC evaluable population: all participants who received at least 1 dose of study drug and at least 1 post-infusion ECG||Beats/minute||Standard Deviation|Mean
676429|NCT01624467|Secondary|PR Change From Time-Matched Baseline ≥25% and Absolute Value of PR > 200 Msec (Electrocardiographic Parameters: PR Interval)||Baseline, Cycle1 Day 1, 8, 15, 22, 29, 36: Pre-infusion, End of Infusion, 1 Hour (hr), 2, 4, 24, 48, 72 hr Post Infusion|QTC evaluable population: all participants who received at least 1 dose of study drug and at least 1 post-infusion ECG.||percentage of participants|||Number
676430|NCT01624467|Secondary|Change From Time-Matched Baseline ≥ 25% and Absolute Value of QRS >110 Msec (Electrocardiographic Parameters: QRS Interval)||Baseline, Cycle1 Day 1, 8, 15, 22, 29, 36: Pre-infusion, End of Infusion, 1 Hour (hr), 2, 4, 24, 48, 72 hr Post Infusion|QTC evaluable population: all participants who received at least 1 dose of study drug and at least 1 post-infusion ECG||participants|||Number
676431|NCT01624467|Primary|Change From Time-Matched Baseline in QT Interval Corrected for Heart Rate (QTc)|The corrected QT interval was calculated using Fridericia’s correction (QTcF) from electrocardiogram (ECG) data. Each participant had triplicate QT intervals measured at each timepoint and the average was calculated for each participant at each timepoint. For each timepoint, a participant’s corresponding baseline (Day -1, pretreatment) QTcF interval was subtracted from the average QTcF intervals to create the change from time-matched baseline in the QTcF interval|Baseline, Cycle1 Day 1, 8,15, 22, 29, and 36: Pre-infusion, End of Infusion, 1 Hour (hr), 2, 4, 24, 48, 72 hr Post Infusion|QTC evaluable population: all participants who received at least 1 dose of study drug and at least 1 post-infusion ECG.||milliseconds (msec)||90% Confidence Interval|Mean
676432|NCT01624363|Primary|Prevalence of Pancreatic Cysts During Routine EUS|The purpose of this study is to identify the prevalence of pancreatic cysts in patients undergoing EUS for non-pancreatic indications .|48 months|||participants found to have a cyst|pancreas'|95% Confidence Interval|Median
676433|NCT01624350|Secondary|Pain|Pain by VAS (Visual Analog Scale) VAS is a 10-point scale with 0 being no pain and 10 being the most pain.|Baseline, 1 month, 3 months, 6 months and 12 months|Participants include number of patients who completed questionnaire||Participants|||Count of Participants
676434|NCT01624350|Secondary|Patient Satisfaction Between the First and Last Post-operative Visit|Patient satisfaction questionnaire included questions regarding fecal continence and overall satisfaction with the operation.|Between the first and last visits|Number of participants completed a satisfaction questionnaire at least twice.||Participants|||Count of Participants
676435|NCT01624350|Secondary|Fecal Incontinence|Fecal Incontinence change from baseline as measured by CCF-FI questionnaire. This questionnaire is a summed score of 5 individual parameters (frequency of incontinence to gas, liquid solid, of need to wear pad, and of lifestyle changes) It is measured from a patient-completed questionnaire with each parameter given a score from 0 to 4, with 0 indicating its absence and 4 indicating daily presence. These values are added to give a total score ranging from 0 to 20 (0 indicating perfect control, 10-15 indicating moderate incontinence, and greater than 15 indicating severe incontinence.|3 months, 6 months and 12 months|The CCF-FI score was calculated if a score was ticked for each of the five types of incontinence. If a patient had a type of incontinence with a missing score, then the CCF-FI score was not calculated. Change = Value and Month X - Value at Baseline.||units on a scale||Standard Deviation|Mean
676436|NCT01624350|Secondary|Participant Response to Quality of Life EQ-5D Questionnaire|Quality of Life by EQ-5D questionnaire is a standardized measure of health status. It is a 25-item questionnaire that measures quality of life of patients pre and post surgery in the following categories: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each category has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.|Baseline, and 3 months, 6 months and 12 months post op|Number analyzed include participants who completed questionnaire.||participants|||Number
681432|NCT01556906|Secondary|Absolute Change From Baseline in Forced Expiratory Volume During 1 Second (FEV1)|Absolute change from Baseline in FEV1|Baseline and 16 weeks of treatment|All patients treated||Liters||Standard Deviation|Mean
676437|NCT01624350|Secondary|Fistula Healing in Patients at 3 and 12 Months Following Surgery|Clinical assessment of fistula healing as defined by 1) no discharge from the fistula and 2) the external opening has closed.|3 months and 12 months|Number of participants analyzed includes patients who had their assessment performed and the final assessment of patients who exited from the study early.||percentage of patients||95% Confidence Interval|Number
676438|NCT01624350|Primary|Fistula Healing in Patients at 6 Months Following Surgery|Clinical assessment of fistula healing as defined by 1) no discharge from the fistula and 2) the external opening has closed.|6 months|Number of participants analyzed includes patients who had their assessment performed and the final assessment of patients who exited from the study early.||percentage of participants|||Number
676439|NCT01624259|Secondary|Percent Change From Baseline in Lipid Parameters at 26 Weeks|A summary of percent change in lipid parameters (total cholesterol, high-density lipoprotein cholesterol [HDL-C], low density lipoprotein cholesterol [LDL-C], very low-density lipoprotein cholesterol [VLDL], and triglycerides) from baseline to primary endpoint of 26 weeks is presented. LS means of the lipid parameter from baseline to primary endpoint at Week 26 were adjusted by fixed effects of treatment, country, baseline HbA1c strata, and lipid parameter baseline as covariates, via ANCOVA with LOCF.|Baseline, Up to 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or liraglutide with evaluable lipid laboratory data. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||percent||Standard Error|Least Squares Mean
676440|NCT01624259|Secondary|Number of Participants With Treatment Emergent LY2189265 Antibodies up to 26 Weeks and 4 Weeks After Last Dose|LY2189265 (dulaglutide) anti-drug antibodies (ADA) were assessed at baseline, 26 weeks, and at the safety follow-up visit 4 weeks after study drug discontinuation in dulaglutide-treated participants. A participant was considered to have treatment emergent LY2189265 ADA if the participant had at least 1 titer that was treatment-emergent relative to baseline, defined as a 4-fold or greater increase in titer from baseline measurement. The number of participants with treatment-emergent LY2189265 ADA from postbaseline to follow up were summarized.|Baseline up to 4 Weeks Post Last Dose of Study Drug|Participants who were randomized and received at least 1 dose of LY2189265 with evaluable LY2189265 ADA data.||participants|||Number
676441|NCT01624259|Secondary|Number of Participants With Allergic or Hypersensitivity Reactions|Allergic and hypersensitivity reactions that were considered possibly related to study drug by the investigator are presented. Serious and all other non-serious adverse events regardless of causality are summarized in the Reported Adverse Events module.|Baseline through 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or liraglutide with evaluable adverse event data.||participants|||Number
676442|NCT01624259|Secondary|Time to Initiation of Additional Intervention for Severe, Persistent Hyperglycemia|An additional intervention (rescue therapy) was defined as any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation. Participants who had no rescue therapy within specified study period were considered as censored observations at the last available contact date up to specified study period.|Baseline through 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or liraglutide with evaluable concomitant medication data.||weeks||95% Confidence Interval|Median
676443|NCT01624259|Secondary|Rate of Hypoglycemic Events Adjusted Per 30 Days|HE were classified as severe (episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (any time a participant felt that he/she was experiencing symptoms and/or signs associated with hypoglycemia and had a PG concentration of ≤70 mg/dL), asymptomatic (events not accompanied by typical symptoms of hypoglycemia but with a measured PG of ≤ 70 mg/dL), nocturnal (events that occurred between bedtime and waking), or probable symptomatic (events during which symptoms of hypoglycemia were not accompanied by a PG determination but that was presumably caused by a PG of ≤70 mg/dL). The hypoglycemia rate per 30 days was calculated by the number of hypoglycemia events within the period/number of days participant at risk within the period*30 days. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or liraglutide with evaluable hypoglycemic episode data. Only pre-rescue measurements were used.||number of events/participant/30 days||Standard Deviation|Mean
676444|NCT01624259|Secondary|Percentage of Participants Requiring Additional Intervention for Severe, Persistent Hyperglycemia|An additional intervention (rescue therapy) was defined as any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation.|Baseline through 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or liraglutide with evaluable concomitant medication data.||percentage of participants|||Number
676445|NCT01624259|Secondary|Percentage of Participants With Self-Reported Hypoglycemia Events|"Hypoglycemic events (HE) were classified as severe (episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (any time a participant felt that he/she was experiencing symptoms and/or signs associated with hypoglycemia and had a plasma glucose [PG] concentration of ≤70 mg/dL), asymptomatic (events not accompanied by typical symptoms of hypoglycemia but with a measured PG of ≤ 70 mg/dL), nocturnal (events that occurred between bedtime and waking), or probable symptomatic (events during which symptoms of hypoglycemia were not accompanied by a PG determination but that was presumably caused by a PG of ≤70 mg/dL).
A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module."|Baseline through 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or liraglutide with evaluable hypoglycemia event data. Only pre-rescue measurements were used.||percentage of participants|||Number
676446|NCT01624259|Secondary|Change From Baseline in Amylase at 26 Weeks|A summary of participants having changes in amylase evaluation from baseline to primary endpoint of 26 weeks is presented.|Baseline, Up to 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or liraglutide with evaluable amylase laboratory data. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||U/L||Inter-Quartile Range|Median
676447|NCT01624259|Secondary|Change From Baseline in Lipase at 26 Weeks|A summary of participants having changes in lipase evaluation from baseline to primary endpoint of 26 weeks is presented.|Baseline, Up to 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or liraglutide with evaluable lipase laboratory data. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||units/liter (U/L)||Inter-Quartile Range|Median
676448|NCT01624259|Secondary|Change From Baseline in Calcitonin at 26 Weeks|A summary of participants having changes in calcitonin values from baseline to primary endpoint of 26 weeks is presented.|Baseline, Up to 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or liraglutide with evaluable calcitonin laboratory data. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||picograms/milliliter (pcg/mL)||Inter-Quartile Range|Median
676449|NCT01624259|Secondary|Number of Participants With Adjudicated Acute Pancreatitis Events|"The number of participants with events of pancreatitis confirmed by adjudication were summarized cumulatively at 26 weeks (including a 30-day follow up). Pancreatitis events were adjudicated by a committee of physicians external to the Sponsor.
A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module."|Baseline up to 30 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or Liraglutide with evaluable adverse event data.||participants|||Number
676450|NCT01624259|Secondary|Change From Baseline in Blood Pressure (BP) at 26 Weeks|Descriptive statistics for the actual measurements and change from baseline for sitting systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured. LS means of change from baseline were calculated using MMRM with treatment, country, visit, and treatment-by-visit interaction as fixed effects, baseline BP as a covariate, and participant as a random effect.|Baseline, 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or liraglutide with evaluable BP data.||milliliters of mercury (mmHg)||Standard Error|Least Squares Mean
676451|NCT01624259|Secondary|Change From Baseline in Heart Rate (HR) at 26 Weeks|Descriptive statistics for the actual measurements and LS means of change from baseline for HR (sitting) by treatment arm were analyzed using the MMRM model with treatment, country, visit, and treatment-by-visit interaction as fixed effects, baseline rate as a covariate, and participant as a random effect.|Baseline, 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or liraglutide with evaluable heart rate data.||bpm||Standard Error|Least Squares Mean
676452|NCT01624259|Secondary|Change From Baseline in Electrocardiogram (ECG) Parameters PR and QTcF (Fridericia's) Intervals at 26 Weeks|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave. QTcF is the measure of the time between the start of the Q wave and the end of the T wave adjusted using Fridericia's formula. PR is the interval between the P wave and the QRS complex. These parameters were calculated from electrocardiogram (ECG) data. LS means of change from baseline for the PR and QTcF intervals will be analyzed using the MMRM similar to MMRM model for primary outcome, using corresponding baseline and HbA1c strata. Only ECGs obtained at scheduled visits will be used in these summaries and analyses.|Baseline, 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or Liraglutide with evaluable ECG PR or QTcF interval data. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||milliseconds (msec)||Standard Error|Least Squares Mean
676453|NCT01624259|Secondary|Change From Baseline in Electrocardiogram (ECG) Parameters, Heart Rate (HR) at 26 Weeks|ECG HR was measured. LS means of change from baseline were analyzed using ANCOVA with HbA1c strata, country, and treatment as fixed effects and baseline HR as a covariate.|Baseline, Up to 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or liraglutide with evaluable ECG heart rate data. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||beats per minute (bpm)||Standard Error|Least Squares Mean
676454|NCT01624259|Secondary|Number of Participants With Reported and Adjudicated Cardiovascular Events|Deaths and nonfatal cardiovascular (CV) adverse events (AEs) were adjudicated by a committee of physicians with cardiology expertise external to the Sponsor. The nonfatal CV AEs to be adjudicated include myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions (such as coronary artery bypass graft or percutaneous coronary intervention), and cerebrovascular events including cerebrovascular accident (stroke) and transient ischemic attack. The number of participants with reported CV events, number of participants with nonfatal CV events confirmed by adjudication, and number of deaths confirmed by adjudication are summarized cumulatively at 26 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline up to 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or liraglutide with evaluable adjudicated CV event data.||participants|||Number
676455|NCT01624259|Secondary|Change From Baseline in Homeostasis Model Assessment 2 Steady-state Beta (β)- Cell Function (HOMA2-%B) at 26 Weeks|"The homeostatic model assessment (HOMA) quantifies insulin resistance and beta-cell function. HOMA2-%B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady-state beta cell function (%B) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%.
LS means of the HOMA2-%B change from baseline to primary endpoint at Week 26 was adjusted by fixed effects of treatment, country, baseline HbA1c strata, and baseline HOMA2-%B value as covariate, via an ANCOVA analysis using LOCF."|Baseline, Up to 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or liraglutide with evaluable HOMA2-%B data. LOCF was used to impute missing postbaseline values. If there was no data after date of randomization, the endpoint was considered missing.||percentage of HOMA2-%B||Standard Error|Least Squares Mean
676456|NCT01624259|Secondary|Percentage of Participants Achieving a Glycosylated Hemoglobin (HbA1c) ≤6.5% or <7% at 26 Weeks|The percentage of participants who achieved the target HbA1c values at the primary endpoint were analyzed with a repeated logistic regression model (the generalized estimation equation [GEE] model). The model includes pooled country, treatment, visit, treatment-by-visit interaction, and baseline HbA1c as continuous covariates.|Up to 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or Liraglutide with evaluable HbA1c data. Only pre-rescue measurements were used. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||percentage of participants|||Number
676457|NCT01624259|Secondary|Change From Baseline in 7-Point Self Monitored Plasma Glucose (SMPG) at 26 Weeks|"The SMPG data were collected at the following 7 time points: pre-morning meal; 2 hours post-morning meal; pre-midday meal; 2 hours post-midday meal; pre-evening meal; 2 hours post-evening meal; and bedtime. The mean of the 7 time points (Daily Mean) was also calculated.
LS means of the SMPG change from baseline to primary endpoint at Week 26 were adjusted by fixed effects of treatment, HbA1c strata, country, visit, treatment-by-visit interaction, participant as random effect and baseline SMPG as a covariate, via a MMRM analysis using REML."|Baseline, 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or liraglutide with evaluable 7-Point SMPG data. Only pre-rescue measurements were used.||mg/dL||Standard Error|Least Squares Mean
676458|NCT01624259|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at 26 Weeks|LS means of the FPG from baseline to primary endpoint at Week 26 were adjusted by fixed effects of treatment, country, baseline HbA1c strata, and baseline FPG as covariates, via ANCOVA with LOCF.|Baseline, Up to 26 Weeks|"Participants who were randomized and received at least 1 dose of LY2189265 or liraglutide with evaluable FPG data. Only pre-rescue measurements were used.
LOCF was used to impute missing postbaseline values. If no data after date of randomization, the endpoint was considered missing."||milligrams/deciliter (mg/dL)||Standard Error|Least Squares Mean
676459|NCT01624259|Secondary|Change From Baseline in Body Mass Index (BMI) at 26 Weeks|BMI is an estimate of body fat based on body weight divided by height squared. LS means of the BMI change from baseline to primary endpoint at Week 26 were calculated using ANCOVA with HbA1c Strata, country, and treatment as fixed effects and baseline BMI as a covariate.|Baseline, Up to 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or liraglutide with evaluable BMI data. Only pre-rescue measurements were used. LOCF was used to impute missing postbaseline values. If no data after date of randomization, the endpoint was considered missing.||kilograms/square meter (kg/m^2)||Standard Error|Least Squares Mean
676460|NCT01624259|Secondary|Change From Baseline in Body Weight at 26 Weeks|LS means of the weight change from baseline to primary endpoint at Week 26 were calculated using analysis of covariance (ANCOVA) with HbA1c Strata, country, and treatment as fixed effects and baseline body weight as a covariate.|Baseline, Up to 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or Liraglutide with evaluable body weight data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If no data after date of randomization, the endpoint was considered missing.||kilograms (kg)||Standard Error|Least Squares Mean
676461|NCT01624259|Primary|Change From Baseline to 26 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c)|Least Squares (LS) means of the glycosylated hemoglobin A1c (HbA1c) change from baseline to the primary endpoint at Week 26 was adjusted by fixed effects of treatment, country, visit, treatment-by-visit interaction, participant as random effect, and baseline HbA1c as covariates, via a mixed-effects model for repeated measures (MMRM) analysis using restricted maximum likelihood (REML).|Baseline, 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or Liraglutide with evaluable HbA1c data||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
676487|NCT01624168|Secondary|Change From Baseline in State Anxiety Scores|Anxiety was measured by the State Trait Anxiety Inventory - State Scale. Lower scores on this scale reflect better outcomes. Scores can range from 20 to 80.|change from baseline to 4 weeks, 10 weeks, 2 month follow-up|||units on a scale||Standard Error|Mean
676488|NCT01624168|Primary|Adherence to Practice After the Intervention|Subjects are considered adherent to practice after the intervention if they practice an average of 2 times per week.|2 months|||participants|||Number
676486|NCT01624168|Secondary|Change From Baseline in Pittsburgh Sleep Quality Index Scores|Sleep quality was measured by the Pittsburgh Sleep Quality Index Total Score. Lower scores on this scale reflect better outcomes. Scores can range from 0 to 21.|baseline, 4 weeks, 10 weeks, 2 month follow-up|||units on a scale||Standard Error|Mean
676492|NCT01623869|Secondary|OS|Overall survival (OS) is the duration of time from the date of registration/randomization to the date of death or the date of last follow-up for patients who remain alive or who are lost to follow-up at the time of the analysis. Kaplan-Meier methodology will be used to estimate the distribution of OS.|From the date of registration to the date of death or the date of last follow-up, assessed up to 18 months|||months||95% Confidence Interval|Median
676493|NCT01623869|Secondary|Progression Free Survival (PFS)|Progression-free survival (PFS) is defined as the duration of time from the start of treatment to time of radiologic or clinical progression or death, whichever occurs first. PFS will be censored at most recent radiographic assessment date for patients remaining alive at the time of the statistical analysis. Kaplan-Meier methodology will be used to estimate the distribution of PFS.|From the start of treatment to time of radiologic or clinical progression or death, whichever occurs first, assessed up to 18 months|||months||95% Confidence Interval|Median
676494|NCT01623869|Primary|Confirmed Response Rate (CR or PR) Using RECIST|"Response and progression will be evaluated using the international RECIST guidelines (v1.1). Patients are evaluated every 8 weeks for disease status, with a subsequent 4 week assessment required to confirm a response.
Complete Response (CR) - All of the following must be true:
Disappearance of all target and non-target lesions,
Each target lesion and non-target lymph node must have reduction in short axis to <1.0 cm.
Partial Response (PR):
At least a 30% decrease from the baseline measurements of the sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes at current evaluation.
Persistence of one or more non-target lesions or non-target lymph nodes. The confirmed response rate is estimated as the number of patients having a CR or PR, divided by the number of eligible patients having at least one post-baseline assessment. The 95% confidence intervals provided using the method of Duffy and Santner."|Up to 18 months|||percentage of participants||95% Confidence Interval|Number
676495|NCT01623830|Secondary|State Trait Anxiety Inventory- Trait (STAI-Trait)|The STAI-Trait is a 20-item self report scale employing a Likert scale format with 4 responses per item (1-4). The possible range of scores is from 20-80, and higher scores indicate greater levels of anxiety. Ten of the STAI items measure feelings of stress and anxiety, while the remaining ten items measure feelings of relaxation.|post-treatment (9 weeks)|||units on a scale||Standard Deviation|Mean
676496|NCT01623830|Secondary|State Trait Anxiety Inventory- State (STAI-State)|The STAI-State is a 20-item self report scale employing a Likert scale format with 4 responses per item (1-4). The possible range of scores is from 20-80, and higher scores indicate greater levels of anxiety.Ten of the STAI items measure feelings of stress and anxiety, while the remaining ten items measure feelings of relaxation.|post-treatment (9 weeks)|||units on a scale||Standard Deviation|Mean
676497|NCT01623830|Secondary|The Beck Depression Inventory (BDI)|a 21-item measure of cognitive and vegetative symptoms of depression is widely used in a variety of populations, including trauma victims and is sensitive to treatment effects on depression. The possible range for scores is 0-63 with higher scores suggesting more severe symptoms of depression.|post-treatment (9 weeks)|||units on a scale||Standard Deviation|Mean
676498|NCT01623830|Primary|The Questionnaire on Attitudes Toward Flying (QAF)|assesses history of FOF, previous treatment, and attitudes toward flying. It includes a 36-item questionnaire rating the level of fear on an 11-point scale ranging from 0 to10 in different flying situations. The possible range of scores is 0 to 360 with higher scores indicating greater fear associated with flying. Test-retest reliability was .92, and split-half reliability was .99.|post treatment (9 weeks)|||units on a scale||Standard Deviation|Mean
676499|NCT01623830|Primary|Fear of Flying Inventory (FFI)|a 33-item scale measuring intensity of FOF. Items are rated on a 9-point scale ranging from 0 ( not at all) to 8 ( very severely disturbing). The possible range of scores is 0-264 with higher total scores indicating greater fear of flying intensity.Test-retest reliability for 15 WL patients was .92, and it has been sensitive to change with treatment.|Post treatment (9 weeks)|||units on a scale||Standard Deviation|Mean
676500|NCT01623479|Secondary|Percentage of Subjects Satisfied Wtih Their Eyelashes|Overall subject satisfaction with their eyelashes was assessed on a 5-point scale (Very Satisfied, Satisfied, Neutral, Unsatisfied, and Very Unsatisfied). The percentage of subjects satisfied and very satisfied is reported.|Day 1|Subjects with all study data||Percentage of Subjects|||Number
676501|NCT01623479|Secondary|Number of Applications of Latisse® Per Week|Number of applications of Latisse® per week as reported by the subjects.|Day 1|Subjects with all study data||Number of Applications||Standard Deviation|Mean
676502|NCT01623479|Primary|Percentage of Subjects Satisfied With Latisse®|Overall subject satisfaction with Latisse® was assessed on a 5-point scale (Very Satisfied, Satisfied, Neutral, Unsatisfied, and Very Unsatisfied). The percentage of subjects satisfied and very satisfied is reported.|Day 1|Subjects with all study data||Percentage of Subjects|||Number
676503|NCT01623466|Primary|Cycle Control|Measurement of unscheduled bleeding/spotting days.|8 weeks|Safety population||days||Standard Deviation|Mean
676504|NCT01623466|Primary|Evaluation of Itching at Patch Application Site|"Self-reported worst skin itching at patch application site by subject using a 4-point scale:
0. None
Mild
Moderate
Severe"|8 weeks|Safety Population||Score||Standard Deviation|Mean
676505|NCT01623466|Primary|Evaluation of Irritation at Patch Application Site|"Self-reported worst skin irritation score at patch application site for each subject using a 4-point irritation scale:
0: None
Mild
Moderate
Severe"|8 weeks|Safety population||Score||Standard Deviation|Mean
676506|NCT01623466|Primary|Evaluation of Patch Adhesion|"Evaluation of worst patch adhesion score for each subject using a 5-point adhesion scale:
0: ≥90% adhered (no lift)
≥75% adhered but <90% (some edges showing lift)
≥50% adhered but <75% (half of system lifts off)
<50% (< half of system lifts off, but undetached)
patch completely detached"|8 weeks|Safety population||Score||Standard Deviation|Mean
676507|NCT01623466|Primary|Levonorgestrel Pharmacokinetic Profile|The subject incidence of minimal LNG level below pre-specified threshold of 175 pg/mL during the study.|8 weeks|Primary PK population||% of subjects below 175 pg/mL|||Number
676508|NCT01623323|Primary|Adverse Events|Adverse Events were collected via spontaneous subject report and through physician examination. The display of adverse events is by subject.|Baseline to 3 months or End of Study|All subject who received at least one dose of study medication||participants|||Number
676779|NCT01618214|Secondary|Percentage of Subjects Achieving HbA1c Below 7.0%||After 20 weeks of treatment|Full analysis set (FAS) - included all randomized subjects and missing data was imputed using last observation carried forward (LOCF) where any post-randomization measurements were available.||percentage (%) of subjects|||Number
676509|NCT01623271|Primary|Visual Analog Scale (VAS) at Visit 3|Subjects rated their pain using the VAS at visit 3, which was the last day of their maintenance phase. After this visit, subjects begin to taper the gralise. The VAS is subject reported on a scale of 0-10 with 0 being no pain and 10 being the worst pain they can imagine. Results reported are an average of the 3 subjects who completed visit 3.|At visit 3|Only 3 subjects completed visit 3. The other 2 subjects dropped out due to expected side effects.||units on the VAS||Standard Deviation|Mean
676510|NCT01623154|Other Pre-specified|Number of Participants Tested Positive/Negative for H. Pylori|"Qualified subjects from clinical sites underwent a standard urea breath test using the BreathTek UBT Kit. Breath samples were analyzed using both the POCone and the UBiT-IR300. DOB values from these two infrared spectrophotometers were converted to respective UHR values using pUHR-CA. The paired UHR values from each subject were evaluated for agreement.
UHR values of >10 µg/min were considered positive for H. pylori and UHR values of <10 µg/min were considered negative for H. pylori."|Single Study Visit (1 hour of testing)|95 evaluable subjects for initial diagnosis - each patient received the BreathTek UBT test. Collected breath samples were analyzed on both the UBiT-IR300 and the POC-one.||Participants|||Number
676511|NCT01623154|Primary|Agreement Between POCone and UBiT-IR300.|"The study end-points are UHR values derived from DOB (delta over baseline) values obtained from the POCone and UBiT-IR300 (UHRP and UHRU, respectively) at Baseline and Post-Dose. Same patients will be tested on both the POCone and UBiT-IR300.
Subjects fasted for at least 1 hr prior test. Each patient provided breath samples in 3 blue (Baseline) breath bags-labeled A B C. Subjects were given Pranactin-Citric solution (4oz) to drink, waited 15 min and collected 3 pink (post-dose) bags which were paired with the baseline bags in no particular order. Each pair was tested on both machines. The first two available pairs of UHR values were used for data analysis. The 3rd pair was used only if one of the first two samples did not produce a valid test result.
DOB values were generated by the two instruments for each Baseline and Post Dose pair. UHR values were claculated based on the DOB values and the subject's anthropometric variables (age, gender, ehight and body weight)."|Baseline, Post Dose (15 min)|Evaluable patients must drink all of the Pranactin-citric solution. Though all three sets of bags were analysed, the first two sets of valid values were used for analysis, regardless of the set designation (A, B or C). The values of individual sets (A, B or C) were not analyzed.||||95% Confidence Interval|Number
676512|NCT01623115|Other Pre-specified|Percent Change From Baseline in Calculated LDL-C at Week 78 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 78 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 78 (i.e. up to 21 days after last injection).|From Baseline to Week 78|mITT population.||percent change||Standard Error|Least Squares Mean
676513|NCT01623115|Other Pre-specified|Percent Change From Baseline in Calculated LDL-C at Week 78 - ITT Analysis|Adjusted LS means and standard errors at Week 78 from MMRM including all available post-baseline data from Week 4 to Week 78 regardless of status on-or off-treatment.|From Baseline to Week 78|ITT population.||percent change||Standard Error|Least Squares Mean
676514|NCT01623115|Other Pre-specified|Percent Change From Baseline in Calculated LDL-C at Week 52 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 52 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|From Baseline to Week 52|mITT population.||percent change||Standard Error|Least Squares Mean
676515|NCT01623115|Secondary|Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Apo A-1 ITT population.||percent change||Standard Error|Least Squares Mean
676516|NCT01623115|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.||percent change||Standard Error|Mean
676517|NCT01623115|Secondary|Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|HDL-C ITT population.||percent change||Standard Error|Least Squares Mean
676518|NCT01623115|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.||percent change||Standard Error|Mean
676519|NCT01623115|Secondary|Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline Apo A-1 value on- or off-treatment (Apo A-1 ITT population).||percent change||Standard Error|Least Squares Mean
676520|NCT01623115|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.||percent change||Standard Error|Mean
676521|NCT01623115|Secondary|Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline HDL-C value on- or off-treatment (HDL-C ITT population).||percent change||Standard Error|Least Squares Mean
676522|NCT01623115|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.||percent change||Standard Error|Mean
677906|NCT01603940|Primary|Endothelial Function|Access endothelial function by brachial flow-mediated vasodilation (FMD) and compare it between groups (losartan and benazepril) and its relationship to current statin use.|12 weeks|||percentage of maximal vasodilation||Inter-Quartile Range|Median
676523|NCT01623115|Secondary|Percentage of Participants Achieving Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis|Adjusted percentages at Week 24 from multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 52 i.e. up to 21 days after last injection.|Up to Week 52|mITT population.||percentage of participants|||Number
676524|NCT01623115|Secondary|Percentage of Participants Achieving Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis|Adjusted percentages at Week 24 from multiple imputation approach model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|Up to Week 52|ITT population.||percentage of participants|||Number
676525|NCT01623115|Secondary|Percentage of Very High CV Risk Participants Achieving Calculated LDL-C < 70 mg/dL (<1.81 mmol/L) or High CV Risk Participants Achieving Calculated LDL-C < 100 mg/dL (<2.59 mmol/L) at Week 24 - On- Treatment Analysis|Adjusted percentages at Week 24 from multiple imputation approach including available post-baseline on-treatment data from Week 4 to Week 52 i.e. up to 21 days after last injection.|Up to Week 52|mITT population.||percentage of participants|||Number
676526|NCT01623115|Secondary|Percentage of Very High Cardiovascular (CV) Risk Participants Achieving Calculated LDL-C < 70 mg/dL (<1.81 mmol/L) or High CV Risk Participants Achieving Calculated LDL-C < 100 mg/dL (<2.59 mmol/L) at Week 24 - ITT Analysis|Very high CV risk participants: Heterozygous Familial Hypercholesterolemia (heFH) participants with coronary heart disease (CHD) or CHD risk equivalents. High CV risk participants: heFH participants without CHD or CHD risk equivalents. CHD risk equivalent: peripheral arterial disease, ischemic stroke, moderate chronic kidney disease (estimated glomerular filtration rate, 30 to <60 ml/minute/1.73 m^2 of body-surface area), or diabetes mellitus plus 2 or more additional risk factors (hypertension; ankle-brachial index of ≤0.90; microalbuminuria, macroalbuminuria, or a urinary dipstick result of >2+ protein; preproliferative or proliferative retinopathy or laser treatment for retinopathy; or a family history of premature CHD). Adjusted percentages at Week 24 were obtained from multiple imputation approach for handling of missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were included in the imputation model.|Up to Week 52|ITT population.||percentage of participants|||Number
676527|NCT01623115|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 52 - ITT Analysis|Adjusted LS means and standard errors at Week 52 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.||percent change||Standard Error|Least Squares Mean
676528|NCT01623115|Secondary|Percent Change From Baseline in Total-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Total-C ITT population.||percent change||Standard Error|Least Squares Mean
676529|NCT01623115|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|non-HDL-C ITT population.||percent change||Standard Error|Least Squares Mean
676530|NCT01623115|Secondary|Percent Change From Baseline in Apo B at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|Apo B ITT population.||percent change||Standard Error|Least Squares Mean
676531|NCT01623115|Secondary|Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline Total-C value on-or off-treatment (Total-C ITT population).||percent change||Standard Error|Least Squares Mean
676532|NCT01623115|Secondary|Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|From Baseline to Week 52|Participants of the mITT population with one baseline and at least one post-baseline non-HDL­C value on-treatment (non-HDL-C mITT population).||percent change||Standard Error|Least Squares Mean
676533|NCT01623115|Secondary|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment (non-HDL-C ITT population).||percent change||Standard Error|Least Squares Mean
676534|NCT01623115|Secondary|Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|From Baseline to Week 52|Participants of the mITT population with one baseline and at least one post-baseline Apo B value on-treatment (Apo B mITT population).||percent change||Standard Error|Least Squares Mean
676535|NCT01623115|Secondary|Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post­baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline Apo B value on- or off-treatment (Apo B ITT population).||percent change||Standard Error|Least Squares Mean
676536|NCT01623115|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|From Baseline to Week 52|mITT population.||percent change||Standard Error|Least Squares Mean
676537|NCT01623115|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM including all available post­baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|ITT population.||percent change||Standard Error|Least Squares Mean
676538|NCT01623115|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection) (on-treatment analysis).|From Baseline to Week 52|Modified ITT (mITT) population: all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.||percent change||Standard Error|Least Squares Mean
676539|NCT01623115|Primary|Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis|Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were used in the model (ITT analysis).|From Baseline to Week 52|ITT population: all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on­ or off-treatment.||percent change||Standard Error|Least Squares Mean
676540|NCT01623050|Secondary|Patency of Treated Area|Maxillary Sinus Ostia of 27 patients analyzed.|12 months|7 patients were lost to follow up||percentage of ostia patent|Participants||Number
676541|NCT01623050|Secondary|Patency of Treated Area|Maxillary Sinus Ostia Patency of 29 patients analyzed.|6 months|5 patients were lost to follow up||percentage of ostia patent|Participants||Number
676542|NCT01623050|Secondary|Number of Participants With Device-related Adverse Events as a Measure of Safety||3 months|||number of participants|||Number
676543|NCT01623050|Secondary|Patency of Treated Area|Maxillary Sinus Ostia Patency of 33 patients analyzed.|3 months|One patient was lost to follow up||percentage of ostia patent|Participants||Number
676544|NCT01623050|Primary|Patency of Treated Area||Immediately post procedure|Number of osita treated||percentage of ostia treated|Participants||Number
676545|NCT01622673|Primary|Number of Participants With Any Clinical or Laboratory Adverse Event (AE)|"An AE is defined as any unfavorable and unintended change in the
structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience."|Up to 7 days after the last dose of study drug|All subjects who received any amount of the study drug were included in the safety population||participants|||Number
676546|NCT01622673|Primary|Mean Time to Maximum Plasma Concentration (Tmax) of Raltegravir|Participant blood samples were collected to measure the time to achieve the maximum steady state plasma concentration of raltegravir when administered alone or with a single dose of antacid|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose|All participants were included for whom at least one PK parameter could be calculated for all treatment periods and who did not have any protocol deviation interfering with pharmacokinetics||hr||Standard Deviation|Mean
676547|NCT01622673|Primary|Least Squares Mean Maximum Plasma Concentration (Cmax) of Raltegravir After Staggered Administration of Antacid (Secondary Hypothesis)|Participant blood samples were collected to measure the maximum steady state plasma concentration of raltegravir after administration alone or before or after a single dose of antiacid. The secondary hypothesis compared Cmax of raltegravir when administered alone with Cmax of raltegravir when administered 2 hours before or after MINTOX®.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose|All participants were included for whom at least one PK parameter could be calculated for all treatment periods and who did not have any protocol deviation interfering with pharmacokinetics||nM||95% Confidence Interval|Least Squares Mean
676548|NCT01622673|Primary|Least Squares Mean Maximum Plasma Concentration (Cmax) of Raltegravir After Coadministration of Antacid (Primary Hypothesis)|Participant blood samples were collected to measure the steady state maximum plasma concentration of raltegravir when administered alone or with a single dose of antacid. The primary hypothesis compared Cmax of raltegravir when administered alone with Cmax of raltegravir when coadministered with TUMS® or MINTOX®.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose|All participants were included for whom at least one PK parameter could be calculated for all treatment periods and who did not have any protocol deviation interfering with pharmacokinetics||nM||95% Confidence Interval|Least Squares Mean
676549|NCT01622673|Primary|Least Squares Mean Steady State Area Under the Plasma Concentration-Time (AUC0-12hrs) of Raltegravir After Staggered Administration of Antacid (Secondary Hypothesis)|Participant blood samples were collected to measure the steady state AUC of raltegravir up to 12 hours after administration alone or before or after a single dose of antacid. The secondary hypothesis compared AUC0-12hrs of raltegravir when administered alone with AUC0-12hrs of raltegravir when administered 2 hours before or after MINTOX®.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose|All participants were included for whom at least one PK parameter could be calculated for all treatment periods and who did not have any protocol deviation interfering with pharmacokinetics||nM*hr||95% Confidence Interval|Least Squares Mean
676550|NCT01622673|Primary|Least Squares Mean Steady State Area Under the Plasma Concentration-time Curve (AUC0-12hrs) of Raltegravir After Coadministration of Antacid (Primary Hypothesis)|Participant blood samples were collected to measure the steady state AUC of raltegravir up to 12 hours after administration alone or with a single dose of antacid. The primary hypothesis compared AUC0-12hrs of raltegravir when administered alone with AUC0-12hrs of raltegravir when coadministered with TUMS® or MINTOX®.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose|All participants were included for whom at least one PK parameter could be calculated for all treatment periods and who did not have any protocol deviation interfering with pharmacokinetics||nM*hr||95% Confidence Interval|Least Squares Mean
676551|NCT01622673|Primary|Least Squares Mean Steady State Plasma Concentration (C12hrs) of Raltegravir After Staggered Administration of Antacid (Secondary Hypothesis)|Participant blood samples were collected to measure the steady state plasma concentration of raltegravir 12 hours after administration alone or before or after a single dose of antacid. The secondary hypothesis compared C12hrs of raltegravir when administered alone with C12hrs of raltegravir when administered 2 hours before or after MINTOX®.|12 hours postdose|All participants were included for whom at least one PK parameter could be calculated for all treatment periods and who did not have any protocol deviation interfering with pharmacokinetics||nM||95% Confidence Interval|Least Squares Mean
677457|NCT01609062|Secondary|Normalized Urine Keratan Sulfate (uKS)|"Urinary KS was measured by a quantitative method and normalized using the sample urinary creatinine measurement.
Percent change from baseline to Week 12, 24, and 52 in normalized urine keratan sulfate (ug/mg)."|Baseline, Week 12, 24, and 52|Modified Intent-to-treat Analysis Set||Percent Change||Standard Deviation|Mean
676552|NCT01622673|Primary|Least Squares Mean Steady State Plasma Concentration (C12hrs) of Raltegravir After Coadministration of Antacid (Primary Hypothesis)|Participant blood samples were collected to measure the steady state plasma concentration of raltegravir 12 hours after administration alone or with a single dose of antacid. The primary hypothesis compared C12hrs of raltegravir when administered alone with C12hrs of raltegravir when coadministered with TUMS® or MINTOX®.|12 hours postdose|All participants were included for whom at least one pharmacokinetic (PK) parameter could be calculated for all treatment periods and who did not have any protocol deviation interfering with pharmacokinetics||nM||95% Confidence Interval|Least Squares Mean
676553|NCT01622660|Primary|Progression Free Survival (PFS)|Progression Free Survival will be calculated from the start of treatment until progressive disease or death. Patients who die before documented progression will be considered failures at their time of death. If the patient did not progress or die, the patient will be censored on the date of last follow-up. Response and progression will be evaluated in this study using the international criteria by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 Measurable lesions: lesions that can be accurately measured in at least one dimension with longest diameter ≥ 10 mm by clinical exam or with spiral CT scan or MRI (no less than double the slice thickness and a minimum of 10mm). Malignant lymph nodes must be 15 mm in the short axis when assessed by spiral CT scan to be considered measurable. Non-measurable lesions: all other lesions (or sites of disease) including small lesions (longest diameter < 20 mm with conventional techniques or < 10 mm u|2 years|||days|||Number
676554|NCT01622296|Primary|Participant Pain Experience After Administration of Local Anesthesia to Numb the Gums and Teeth During Dental Treatment|"Two treatment visits were required for bilateral, mandibular dental operative restorations. At each visit, local anesthetic was delivered to the right or left side of the dentition using one of the two anesthetic types. The administering operator stepped out of the room after each injection was completed, and the participant was asked by a trained research assistant to record a visual analog scale (VAS) pain score. The VAS was used to assess pain sensitivity, and utilizes a 100mm horizontal line, with scores ranging from 0 (no pain) to 100 (pain as bad as it can be)."|immediately after anesthetic injection|per protocol, in a crossover fashion, each participant received buffered lidocaine at one treatment visit and lidocaine at one treatment visit, in randomly assigned sequence.||units on a scale||Standard Deviation|Mean
676555|NCT01622257|Secondary|Change in Lipid Profile|Change in LDL levels was taken as the indicator of change in lipid profile|Baseline and 3 months|||mg/dl||95% Confidence Interval|Mean
676556|NCT01622257|Secondary|Change in Serum Free Testosterone Level|Change in serum free testosterone levels|Baseline and 3 months|||pg/ml||95% Confidence Interval|Mean
676557|NCT01622257|Secondary|Change in Insulin Resistance|Change in Fasting insulin concentration|Baseline and 3 months|||uIU/ml||95% Confidence Interval|Mean
676558|NCT01622257|Secondary|Ovulation Rate as Determined by Ultrasonographic Folliculometry and Luteal Serum Progesterone Assay.|"The Number of participants who had evidence of successful ovulation during the 3 months. Ovulation was diagnosed based on ultrasonographic folliculometry and/or luteal serum progesterone assay.Every month, folliculometry was done to count the number of antral follicles (AFC), follow follicular growth, measure dominant follicle diameter and detect occurrence of ovulation. a mid-luteal serum progesterone assay was done to confirm ovulation.
Ultrasound was performed serially till reaching preovulatory follicle(s of around 20 mm in diameter that then rupture to show a collapsed follicle in the same location with internal echoes consistent with its transformation to a corpus luteum. Progesterone assay was done using immulite 2000 apparatus chemiluminescent immunometric assay. Mid-luteal phase progesterone above 6 ng/mL was considered indicative of normal corpus. luteum function."|3 months|||participants|||Number
676559|NCT01622257|Primary|Clinical Pregnancy Rate||9 months|||participants|||Number
676560|NCT01622231|Secondary|Number of Participants With the Indicated Plasma Concentration of GW685698X for Participants Aged >=6 to <15 Years|PK samples were collected to analyze the plasma concentration of GW685698X.|Between 0.5 to 2 hours after final dosing at Week 12 (Visit 5)|PK Concentration Population. Only those participants aged >=6 to <15 years were assessed.||participants|||Number
676561|NCT01622231|Secondary|Number of Participants With the Indicated Plasma Concentration of GW685698X for Participants Aged >=2 to <6 Years|Pharmacokinetic (PK) samples were collected to analyze the plasma concentration of GW685698X.|Between 0.5 to 2 hours after final dosing at Week 12 (Visit 5)|PK Concentration Population: all participants from whom a PK sample was obtained and analyzed. Only those participants aged >=2 to <6 years were assessed.||participants|||Number
676562|NCT01622231|Secondary|Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Participant’s Parent/Guardian or the Participant|The participant's parent/guardian who signed the ICF or the participant himself/herself evaluated the participant's overall response to therapy (defined as improvement in the symptoms of allergic rhinitis) compared with Visit 2 (start of the treatment period), using the following 7-point categorical scale: 1=significantly improved, 2=moderately improved, 3=mildly improved, 4=no change, 5=mildly worse, 6=moderately worse, and 7=significantly worse.|Week 12/early withdrawal|FAS Population||participants|||Number
676563|NCT01622231|Secondary|Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Investigator|The investigator evaluated the participant's overall response to therapy (defined as improvement in the symptoms of allergic rhinitis) compared with Visit 2 (start of the treatment period), using the following 7-point categorical scale: 1=significantly improved, 2=moderately improved, 3=mildly improved, 4=no change, 5=mildly worse, 6=moderately worse, and 7=significantly worse.|Week 12/early withdrawal|FAS Population||participants|||Number
676564|NCT01622231|Secondary|Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge)|Rhinoscopy was assessed by the investigator by scoring swelling of inferior turbinate mucosa (SOITM) scored as 0 (none), 1 (possible to see center of the middle turbinate), 2 (between 3 and 1), or 3 (impossible to see middle turbinate); color of inferior turbinate mucosa (COITM) scored as 0 (normal), 1 (pink), 2 (red), or 3 (pale); quantity of nasal discharge (QTND) scored as 0 (none), 1 (small amount adhered), 2 (between 3 and 1), or 3 (filled); and quality of nasal discharge (QLND) scored as 0 (none), 1 (pyoid), 2 (viscous), or 3 (watery).|Baseline, Week 4, Week 8, and Week 12/early withdrawal|FAS Population. Only those participants available at the indicated time points were assessed.||participants|||Number
676565|NCT01622231|Secondary|Mean Change From Baseline in the Score of Troubles With Daily Life Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|The participant's parent/guardian who signed the ICF or the participant themself scored the participant's troubles with daily life once daily using the following scale: 0, None; 1, Few troubles; 2, Intermediate between 3 and 1; or 3, Painful and complicating daily life. The mean of the Baseline period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12. For each assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|FAS Population. Only those participants available at the indicated time points were assessed.||Scores on a scale||Standard Deviation|Mean
676566|NCT01622231|Secondary|Mean Change From Baseline in Eye Itching, Tearing, and Redness Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|Three individual symptoms (eye itching, tearing, and redness) were scored by the participant's parent/guardian who signed the ICF or the participant themself using a scale of 0, 1, 2, or 3 (a larger score indicates more severe symptoms) and were recorded in the participant's diary. The mean of the Baseline period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12. For each assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|FAS Population. Only those participants available at the indicated time points were assessed.||Scores on a scale||Standard Deviation|Mean
676567|NCT01622231|Secondary|Mean Change From Baseline in Sneezing, Rhinorrhea, Nasal Congestion, and Nasal Itching Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|Four individual symptoms (sneezing, rhinorrhea, nasal congestion, and nasal itching) were scored on a scale from 0 to 3 using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average of the symptom scores in the last 4 consecutive days prior to Visit 2 (start of the treatment period). A mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|FAS Population. Only those participants available at the indicated time points were assessed.||Scores on a scale||Standard Deviation|Mean
676568|NCT01622231|Secondary|Mean Percent Change From Baseline in the Total Ocular Symptom Score (TOSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|Symptoms of eye itching, tearing, and redness were scored by the participant's parent/guardian who signed the ICF or the participant themself using a scale of 0, 1, 2, or 3 (a larger score indicates more severe symptoms) and were recorded in the participant's diary. The TOSS is the sum of all three symtpom scores and ranges from 0 to 9. The mean of the Baseline period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12. For each assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Percent change from Baseline=(mean score at the post-Baseline assessment minus the score at Baseline) divided by the Baseline value * 100.|Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|FAS Population. Only those participants available at the indicated time points were assessed.||Percent change||Standard Deviation|Mean
676569|NCT01622231|Secondary|Mean Change From Baseline in the Total Ocular Symptom Score (TOSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|Symptoms of eye itching, tearing, and redness were scored by the participant's parent/guardian who signed the ICF or the participant themself using a scale of 0, 1, 2, or 3 (a larger score indicates more severe symptoms) and were recorded in the participant's diary. The TOSS is the sum of all three symtpom scores and ranges from 0 to 9. The mean of the Baseline period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12. For each assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|FAS Population. Only those participants available at the indicated time points were assessed.||Scores on a scale||Standard Deviation|Mean
676577|NCT01622231|Secondary|Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyltransferase (GGT) at Week 4 and Week 12/Early Withdrawal|Change from Baseline was calculated as the value at the post-Baseline time points minus the value at Baseline.|Baseline, Week 4, and Week 12/Early Withdrawal|Safety Population. Only those participants available at the indicated time points were assessed.||International units (IU)/L||Standard Deviation|Mean
676578|NCT01622231|Secondary|Change From Baseline in Albumin and Total Protein at Week 4 and Week 12/Early Withdrawal|Change from Baseline was calculated as the value at the post-Baseline time points minus the value at Baseline.|Baseline, Week 4, and Week 12/Early Withdrawal|Safety Population. Only those participants available at the indicated time points were assessed.||grams/L||Standard Deviation|Mean
677505|NCT01608308|Secondary|Number of Participants Who Experienced Postoperative Morbidity (Nausea)|Post-operative nausea will be monitored and measured through direct observation and nursing clinical record|During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)|||participants|||Number
676570|NCT01622231|Secondary|Mean Percent Change From Baseline in the 4 Total Nasal Symptom Score (4TNSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|The 4TNSS is the sum of the 4 individual symptom scores for sneezing, rhinorrhea, nasal congestion, and nasal itching. Each symptom is scored on a scale from 0 to 3; the range of sums for the 4TNSS is 0 to 12. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average of the 4TNSS in the last 4 consecutive days prior to Visit 2 (start of the treatment period). A mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Percent change from Baseline=(mean score at the post-Baseline assessment minus the score at Baseline) divided by the Baseline value * 100.|Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|FAS Population. Only those participants available at the indicated time points were assessed.||Percent change||Standard Deviation|Mean
676571|NCT01622231|Secondary|Mean Change From Baseline in the 4 Total Nasal Symptom Score (4TNSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|The 4TNSS is the sum of the 4 individual symptom scores for sneezing, rhinorrhea, nasal congestion, and nasal itching. Each symptom is scored on a scale from 0 to 3; the range of sums for the 4TNSS is 0 to 12. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average of the 4TNSS in the last 4 consecutive days prior to Visit 2 (start of the treatment period). A mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|FAS Population. Only those participants available at the indicated time points were assessed.||Scores on a scale||Standard Deviation|Mean
676572|NCT01622231|Secondary|Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS)|The 3TNSS is the sum of the 3 individual symptom scores for sneezing, rhinorrhea, and nasal congestion. Each symptom is scored on a scale from 0 to 3; the range of sums for the 3TNSS is 0 to 9. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the informed consent form (ICF) or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The BL value is defined as the average 3TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). For the entire assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from BL was calculated as the mean score for the entire treatment period minus the score at BL. Only those participants available at the indicated time points were assessed.|Baseline, Day 1 to Day 84|Full Analysis Set (FAS) Population: all participants meeting the primary criteria for enrollment, without any major good clinical practice (GCP) deviation, who received at least one dose of the assigned treatment and had diary assessment for 3TNSS after receiving a dose of study medication.||Scores on a scale||Standard Deviation|Mean
676573|NCT01622231|Secondary|Mean Percent Change From Baseline in the 3 Total Nasal Symptom Score (3TNSS) Over the Entire Treatment Period, Week 1to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|The 3TNSS is the sum of the 3 individual symptom scores for sneezing, rhinorrhea, and nasal congestion. Each symptom is scored on a scale from 0 to 3; the range of sums for the 3TNSS is 0 to 9. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the informed consent form (ICF) or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average 3TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). For the entire assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Percent change from Baseline=(mean score at the post-Baseline assessment minus the score at Baseline) divided by the Baseline value * 100.|Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|FAS Population. Only those participants available at the indicated time points were assessed.||Percent change||Standard Deviation|Mean
676574|NCT01622231|Secondary|Mean Change From Baseline in the 3 Total Nasal Symptom Score (3TNSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|The 3TNSS is the sum of the 3 individual symptom scores for sneezing, rhinorrhea, and nasal congestion. Each symptom is scored on a scale from 0 to 3; the range of sums for the 3TNSS is 0 to 9. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the informed consent form (ICF) or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average 3TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). For the entire assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the mean score for the entire treatment period minus the score at Baseline.|Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|FAS Population. Only those participants available at the indicated time points were assessed.||Scores on a scale||Standard Deviation|Mean
676575|NCT01622231|Secondary|Change From Baseline in Calcium, Chloride, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 4 and Week 12/Early Withdrawal|Change from Baseline was calculated as the value at the post-Baseline time points minus the value at Baseline.|Baseline, Week 4, and Week 12/Early Withdrawal|Safety Population. Only those participants available at the indicated time points were assessed.||Millimoles (mmol)/L||Standard Deviation|Mean
676576|NCT01622231|Secondary|Change From Baseline in Direct Bilirubin, Total Bilirubin, and Creatinine at Week 4 and Week 12/Early Withdrawal|Change from Baseline was calculated as the value at the post-Baseline time points minus the value at Baseline.|Baseline, Week 4, and Week 12/Early Withdrawal|Safety Population. Only those participants available at the indicated time points were assessed.||Micromoles (μmol)/L||Standard Deviation|Mean
676579|NCT01622231|Secondary|Change From Baseline in Hematocrit at Week 4 and Week 12/Early Withdrawal|Change from Baseline was calculated as the value at the post-Baseline time points minus the value at Baseline.|Baseline, Week 4, and Week 12/Early Withdrawal|Safety Population. Only those participants available at the indicated time points were assessed.||Proportion of RBCs in blood||Standard Deviation|Mean
676580|NCT01622231|Secondary|Change From Baseline in Red Blood Cell (RBC) Count at Week 4 and Week 12/Early Withdrawal|Change from Baseline was calculated as the value at the post-Baseline time points minus the value at Baseline.|Baseline, Week 4, and Week 12/Early Withdrawal|Safety Population. Only those participants available at the indicated time points were assessed.||tera (10^12) cells (TI)/L||Standard Deviation|Mean
676581|NCT01622231|Secondary|Change From Baseline in Platelet Count and White Blood Cell (WBC) Count at Week 4 and Week 12/Early Withdrawal|Change from Baseline was calculated as the value at the post-Baseline time points minus the value at Baseline.|Baseline, Week 4, and Week 12/Early Withdrawal|Safety Population. Only those participants available at the indicated time points were assessed.||giga (10^9) cells (GI)/L||Standard Deviation|Mean
676582|NCT01622231|Secondary|Change From Baseline in Hemoglobin at Week 4 and Week 12/Early Withdrawal|Change from Baseline was calculated as the value at the post-Baseline time points minus the value at Baseline.|Baseline, Week 4, and Week 12/Early Withdrawal|Safety Population. Only those participants available at the indicated time points were assessed.||Grams per liter (grams/L)||Standard Deviation|Mean
676583|NCT01622231|Secondary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophil Count at Week 4 and Week 12/Early Withdrawal|Change from Baseline was calculated as the value at the post-Baseline time points minus the value at Baseline. Basophils, eosinophils, lymphocytes, monocytes, and total neutrophil counts are measured as the percentage of cells in white blood cells.|Baseline, Week 4, and Week 12/Early Withdrawal|Safety Population. Only those participants available at the indicated time points were assessed.||Percentage of cells||Standard Deviation|Mean
676584|NCT01622231|Primary|Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an other important medical event, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs (occurring at a frequency threshold >=5%) and SAEs.|From the start of study treatment (Visit 2) until follow-up contact (Visit 6) (up to 13 weeks)|Safety Population: all participants who received at least one dose of medication||participants|||Number
676693|NCT01620060|Primary|Lurasidone Peak Serum Concentration (Cmax)|Cmax will be listed and summarized in tabular format|Day 1 - pre-dose, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, and 48 hours. Day 10/12: 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours|||ng/mL||Standard Deviation|Mean
676611|NCT01621776|Secondary|Difference Between Pre- and 120 Minute Post-prandial Blood Glucose Concentrations at Breakfast|Blood glucose concentrations were measured prior to and 120 minutes following breakfast. Analysis was based on intention to treat. While missing data was imputed, it was known that this data was 'not missing at random' thus violating standard statistical assumptions with imputation. Therefore imputed data was not included in the final model.|averaged over 5 days|||mg/dl||Standard Deviation|Mean
676612|NCT01621776|Secondary|Difference Between Pre- and 120 Minute Post-prandial Blood Glucose Concentrations at Dinner|Blood glucose concentrations were measured prior to and 120 minutes following dinner. Analysis was based on intention to treat. While missing data was imputed, it was known that this data was 'not missing at random' thus violating standard statistical assumptions with imputation. Therefore imputed data was not included in the final model.|averaged over 5 days|||mg/dl||Standard Deviation|Mean
676613|NCT01621776|Primary|The Difference Between Pre- and 120 Minute Post-prandial Blood Glucose Concentrations at Lunch.|"Blood glucose concentrations were measured prior to and 90 minutes following lunch. Analysis was based on intention to treat. While missing data was imputed, it was known that this data was 'not missing at random' thus violating standard statistical assumptions with imputation. Therefore imputed data was not included in the final model.
The number of participants for analysis was based upon a convenience sample of individuals attending Florida Camp for Children and Youth with Diabetes at Camp Winona."|averaged over 5 days|Post-Prandial Blood Glucose Values [Within 90 minutes following the completion of participant lunch]||mg/dl||Standard Deviation|Mean
676614|NCT01621672|Primary|Progression Free Survival (PFS)|"Progression was defined as any one or more of the following:
Serum M protein increase ≥ 25% from baseline (or an increase of ≥ 1 g/dL if serum M protein was ≥ 5 g/dL at baseline), with an absolute increase of ≥ 0.5 g/dL; or
Urine M protein increase ≥ 25% from baseline, with an absolute increase of ≥ 200 mg/24 hrs; or
If patient had serum M protein < 1 g/dL, urine M protein < 200 mg/24 hrs, and an involved serum free light chain level ≥ 10 mg/dL at baseline: ≥ 25% increase in the difference between involved and uninvolved serum free light chain level, with an absolute increase of ≥ 10 mg/dL; or
Bone marrow plasma cell percentage increase ≥ 25% from baseline, with the absolute plasma cell % ≥ 10%; or
New bone lesions or soft tissue plasmacytomas, or definite increase in size of existing bone lesions or soft tissue plasmacytomas; or
Development of hypercalcemia (corrected serum calcium > 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to multiple myeloma."|2 years|||percentage of participants|||Number
676615|NCT01621633|Secondary|Number of Participants With Adverse Events, Serious Adverse Events and Death|Adverse events, serious adverse events and death were monitored from screening to end of study|From the screening visit until Day 5|Safety set: The safety set includes all participants who received study treatment.||Participants|||Number
676616|NCT01621633|Primary|Maximum Plasma Concentration (Cmax) for LCZ696 Analytes (AHU377, LBQ657, and Valsartan)|Blood samples were taken on Day 1 (treatment day) within 60 minutes prior to dosing, then, 0.5,1,1.5,2,3,4,6,8,12 hours after the dosing and on Days 2, 3, 4 and 5 post dosing|From pre-dose on Day 1 until 96h post-dose (Day 5)|PK analysis set||ng/mL||Standard Deviation|Mean
676617|NCT01621633|Primary|Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time [AUCinf)] of LCZ696 Analytes (AHU377, LBQ657, and Valsartan)|Blood samples were taken on Day 1 (treatment day) within 60 minutes prior to dosing, then, 0.5,1,1.5,2,3,4,6,8,12 hours after the dosing and on Days 2, 3, 4 and 5 post dosing|From pre-dose on Day 1 until 96h post-dose (Day 5)|PK analysis set||ng*hr/mL||Standard Deviation|Mean
676618|NCT01621633|Primary|Area Under the Plasma Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LCZ696 Analytes (AHU377, LBQ657, and Valsartan)|Blood samples were taken on Day 1 (treatment day) within 60 minutes prior to dosing, then, 0.5,1,1.5,2,3,4,6,8,12 hours after the dosing and on Days 2, 3, 4 and 5 post dosing|From pre-dose on Day 1 until 96h post-dose (Day 5)|PK analysis set: The PK analysis set included all subjects with at least one available, valid (i.e. not flagged for exclusion) PK concentration measurement, who received any study drug, and experienced no protocol deviations with relevant impact on PK data.||ng*hr/mL||Standard Deviation|Mean
676619|NCT01621477|Secondary|Number of Participants With Transplant Related Mortality (TRM)|The number of participants who died due to TRM in the first 100 days post-transplant is given.|100 days post transplant|||participants|||Number
676620|NCT01621477|Secondary|Incidence and Severity of Chronic Graft Versus Host Disease (GVHD)|The severity of chronic GVHD will be described. Chronic GVHD was evaluated using NIH Consensus Global Severity Scoring. The number of participants with chronic GVHD is given, organized by severity.|100 days post transplant|||participants|||Number
676621|NCT01621477|Secondary|Incidence and Severity of Acute Graft Versus Host Disease (GVHD)|The number of participants with acute GVHD is given, organized by grade. Participants are graded on a scale from 1 to 4, with 1 being mild and 4 being severe.|100 days post transplant|||participants|||Number
676622|NCT01621477|Secondary|Disease-Free Survival (DFS)|Estimate the DFS at one-year post-transplantation. The event is defined as relapse or death due to relapse. The number of participants who did not relapse up to one year post transplant is reported.|one year post transplant|||participants|||Number
676623|NCT01621477|Secondary|Event-Free Survival (EFS)|Estimate the EFS at one-year post-transplantation. The event is defined as relapse or death due to any cause. The number of participants who were alive without relapse at one year post-transplant is reported.|one year post transplant|||participants|||Number
676624|NCT01621477|Secondary|Incidence of Malignant Relapse|Estimate the incidence of malignant relapse at one year post-transplant. The number of participants with malignant relapse or progressive disease is given. Relapse was evaluated using standard WHO criteria for each disease.|One year post transplantation.|||participants|||Number
676625|NCT01621477|Primary|One-year Survival (OS)|Evaluate the number of participants alive at 1 year. The number of participants surviving to one-year post-transplantation is given.|One year post transplant|||participants|||Number
676626|NCT01621191|Secondary|Change From Baseline to 50-Week Endpoint in Widespread Pain Index (WPI) and Symptom Severity (SS) in American College of Rheumatology (ACR) Fibromyalgia Diagnostic Criteria 2010|WPI: Participant-reported areas (out of 19 points on the body) in which the participant had pain in the past week. WPI scores ranged from 0 (no areas) to 19 (all areas). SS: The sum of severity scores for fatigue, waking unrefreshed, and cognitive symptoms [each rated from 0 (no problem) to 3 (severe; life-disturbing problems)] plus the severity of somatic symptoms in general [rated from 0 (no symptoms) to 3 (a great deal of symptoms)]. The total SS score ranged from 0 and 12.|Baseline, 50 weeks|Enrolled participants who received at least 1 dose of study drug and had a Week 50 WPI or SS assessment.||units on a scale||Standard Deviation|Mean
676741|NCT01618708|Secondary|Percentage of WOMAC A1 Responder Over 26 Weeks|WOMAC A1 responder rate defined as ≥2 point improvement on 11-point NRS Scale, generalized estimating equations modeling was used for the analysis of WOMAC A1 responders.|From Baseline to Week 26|ITT population.||Percentage of participants|||Number
676627|NCT01621191|Secondary|Change From Baseline to 50-Week Endpoint in Beck Depression Inventory-II (BDI-II)|The BDI-II is a 21-item self-administered questionnaire designed to assess the characteristics of depression. Each item was scored on a 4-point scale ranging from 0 (not present) to 3 (present in the extreme) and was summed to give a total BDI-II score. A total BDI-II score of 0 through 13 was considered minimal, 14 through 19 was mild, 20 through 28 was moderate, and 29 through 63 was severe depression symptoms.|Baseline, 50 weeks|Enrolled participants who received at least 1 dose of study drug and had a Week 50 BDI-II assessment.||units on a scale||Standard Deviation|Mean
676628|NCT01621191|Secondary|Change From Baseline to 50-Week Endpoint in 36-Item Short-Form (SF-36) Health Survey Domain Scores|The SF-36 Health Survey is a generic, health-related survey assessing the participant's quality of life on 8 domains: physical functioning, daily functioning (physical), bodily pain, general health, vitality, social functioning, daily functioning (emotional), and mental health. Each domain was scored by summing individual items pertaining to that domain and transforming scores into a 0 to 100 scale, with higher scores indicating better health status or functioning.|Baseline, 50 weeks|Enrolled participants who received at least 1 dose of study drug and had a Week 50 SF-36 assessment.||units on a scale||Standard Deviation|Mean
676629|NCT01621191|Secondary|Change From Baseline to 50-Week Endpoint in Brief Pain Inventory-Severity (BPI-S) and Brief Pain Inventory-Interference (BPI-I) Scores on the BPI-Modified Short Form|BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function, respectively. Severity scores ranged from 0 (no pain) to 10 (severe pain) for each question assessing average pain, worst pain, least pain, and pain right now. Interference scores ranged from 0 (does not interfere) to 10 (completely interferes) for each question assessing interference of pain in past 24 hours with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference was the average of non-missing scores of individual interference items.|Baseline, 50 weeks|Enrolled participants who received at least 1 dose of study drug and had a Week 50 BPI-S or BPI-W assessment.||units on a scale||Standard Deviation|Mean
676630|NCT01621191|Secondary|Change From Baseline to 50-Week Endpoint in Fibromyalgia Impact Questionnaire (FIQ)|FIQ is a 20-item, self-administered questionnaire using Likert-type scales to measure participant outcomes over the past week. Items 1 through 11 measured physical functioning on 4-point scales. Items 12 and 13 measured the number of days a participant felt well and days a participant was unable to work due to fibromyalgia symptoms, respectively. Items 14 through 20 were 11-point scales on which a participant rated work difficulty, pain, fatigue, morning tiredness, stiffness, anxiety, and depression, respectively. If a participant did not do all the tasks listed, those items were deleted from scoring. Algorithms were used to determine total FIQ scores which ranged from 0 to 100; higher scores indicated a more negative impact.|Baseline, 50 weeks|Enrolled participants who received at least 1 dose of study drug and had a Week 50 FIQ assessment.||units on a scale||Standard Deviation|Mean
676631|NCT01621191|Secondary|Clinical Global Impression-Improvement (CGI-I) at Endpoint|CGI-I measures the clinician's perception of participant improvement at the time of assessment (compared with the start of treatment). Scores ranged from 1 (very much better) to 7 (very much worse).|50 weeks|Enrolled participants who received at least 1 dose of study drug and had a Week 50 CGI-I assessment.||units on a scale||Standard Deviation|Mean
676632|NCT01621191|Secondary|Patient Global Impression-Improvement (PGI-I) at Endpoint|PGI-I measures the participant's perception of improvement at the time of assessment compared with the start of treatment. Scores ranged from 1 (very much better) to 7 (very much worse).|50 weeks|Enrolled participants who received at least 1 dose of study drug and had a Week 50 PGI-I assessment.||units on a scale||Standard Deviation|Mean
676633|NCT01621191|Primary|Number of Participants Who Experienced an Adverse Event (AE)|A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.|Baseline through 53 weeks|Enrolled participants who received at least 1 dose of study drug.||participants|||Number
676634|NCT01621178|Secondary|Percentage of Participants With Allergic/Hypersensitivity Reactions||Baseline through 52 Weeks||12/2017||||
676635|NCT01621178|Secondary|Rate of HE||Baseline, 52 Weeks||12/2017||||
676636|NCT01621178|Secondary|Percentage of Participants With Self-Reported HE||Baseline, 52 Weeks||12/2017||||
676637|NCT01621178|Secondary|Change From Baseline in Body Weight||Baseline, 52 Weeks||12/2017||||
676638|NCT01621178|Secondary|Change From Baseline in Urinary Albumin to Creatinine Ratio (UACR)||Baseline, 52 Weeks||12/2017||||
676639|NCT01621178|Secondary|Change From Baseline in Estimated Creatinine Clearance (eCrCl)||Baseline, 52 Weeks||12/2017||||
676640|NCT01621178|Secondary|Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)||Baseline, 52 Weeks||12/2017||||
676641|NCT01621178|Secondary|Change From Baseline in Serum Creatinine (sCr)||Baseline, 52 Weeks||12/2017||||
676642|NCT01621178|Secondary|Percentage of Participants With Estimated Average Glucose <154 mg/dL||Baseline, 52 Weeks||12/2017||||
676643|NCT01621178|Secondary|Change in Mean Daily Insulin Lispro Dose||Baseline, 52 Weeks||12/2017||||
676644|NCT01621178|Secondary|Change From Baseline in Fasting Glucose||Baseline, 52 Weeks||12/2017||||
676645|NCT01621178|Secondary|Change From Baseline in 8-Point Self-Monitored Plasma Glucose (SMPG)||Baseline, 52 Weeks||12/2017||||
676646|NCT01621178|Secondary|Percentage of Participants Whose HbA1c is <8.0%||Baseline, 52 Weeks||12/2017||||
676647|NCT01621178|Secondary|Percentage of Participants Whose HbA1c is <7.0%||52 Weeks||12/2017||||
676648|NCT01621178|Secondary|Change From Baseline in HbA1c||Baseline, 52 Weeks||12/2017||||
676649|NCT01621178|Secondary|Rate of Hypoglycemic Events|Hypoglycemic events (HE) were classified as total HE rate, documented symptomatic hypoglycemia, severe hypoglycemia, and nocturnal. The 1-year adjusted rate of HEs was summarized cumulatively at 26 weeks. A summary of other nonserious AEs, and all SAEs, regardless of causality, is located in the Reported Adverse Events section.|Baseline through 26 Weeks|All randomized participants who had received at least one dose of study drug and had evaluable post-baseline HE rate data. Only measurements prior to rescue or study drug discontinuation were used.||Events/Participant/Year||Standard Deviation|Mean
676821|NCT01617655|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|ITT population.||percent change||Standard Error|Mean
676650|NCT01621178|Secondary|Percentage of Participants With Self-Reported Hypoglycemic Events (HE)|Hypoglycemic events (HE) were classified as severe (defined as an episode requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of ≤3.9 mmol/L (≤70 mg/dL), nocturnal (defined as any hypoglycemic event that occurs between bedtime and waking). The number of self-reported hypoglycemic events was summarized cumulatively at 26 weeks. A summary of other nonserious AEs, and all SAEs, regardless of causality, is located in the Reported Adverse Events section.|Baseline through 26 Weeks|All randomized participants who received at least one dose of study drug and had evaluable post-baseline HE data. Only measurements prior to rescue or study drug discontinuation were used.||percentage of participants|||Number
676651|NCT01621178|Secondary|Change From Baseline in Body Weight|LS means were calculated from a REML based MMRM model: Change from Baseline = treatment , week, treatment*Week, MA-region, Baseline HbA1c (%), Baseline Body Weight (kg), Baseline CKD Severity, Log Baseline eGFR (within CKD severity), where participant enters the model as a random effect. Covariance structure = Unstructured.|Baseline, 26 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline body weight data. Only measurements prior to rescue or study drug discontinuation were used.||kilogram (kg)||Standard Error|Least Squares Mean
676652|NCT01621178|Secondary|Change From Baseline in Urinary Albumin to Creatinine Ratio (UACR)|The change from baseline in Urinary Albumin to Creatinine Ratio (UACR).|Baseline, 26 Weeks|All randomized participants who received one dose of study drug and had evaluable baseline and post-baseline UACR data.||gram/kilogram (g/kg)||Inter-Quartile Range|Median
676653|NCT01621178|Secondary|Change From Baseline in Estimated Creatinine Clearance (eCrCl)|eEstimated creatinine clearance (eCrCl) was calculated by Cockcroft-Gault [Cockcroft and Gault 1976] equation using baseline estimated lean body weight.|Baseline, 26 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline eCrCl data.||milliliter/minute (ml/min)||Inter-Quartile Range|Median
676654|NCT01621178|Secondary|Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)|The change in estimated glomerular filtration rate (eGFR) by using CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) equation.|Baseline, 26 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline eGFR data.||milliliter/minute/1.73m2 (mL/min/1.73m2)||Inter-Quartile Range|Median
676655|NCT01621178|Secondary|Change From Baseline in Serum Creatinine (sCr)|Change from baseline in serum creatinine (sCr) levels after treatment.|Baseline, 26 Weeks|All randomized participants who received one dose of study drug and had evaluable baseline and post-baseline sCr data.||mg/dL||Inter-Quartile Range|Median
676656|NCT01621178|Secondary|Percentage of Participants With Estimated Average Glucose <154 mg/dL|Percentage of Participants With Estimated Average Glucose <154 milligram/deciliter (mg/dL) was based on last observation carried forward (LOCF).|26 Weeks|All randomized participants who received at least one dose of study drug and had evaluable HbA1c and average self-monitored plasma glucose post-baseline data. Only measurements prior to rescue or study drug discontinuation were used.||percentage of participants|||Number
676657|NCT01621178|Secondary|Change From Baseline in Mean Daily Insulin Lispro Dose|The mean daily insulin was based on a 4-week interval prior to week 26 assessments. LS means were calculated using a REML based mixed-effects model for repeated measures (MMRM) with the change in HbA1c as the dependent variable and treatment, MA-region, Baseline HbA1c, baseline mean daily insulin, baseline CKD Severity, week, treatment*week, baseline HbA1c (%), log baseline eGFR (within CKD severity), and participant was the random effect. Covariance structure = Unstructured.|26 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline HbA1c and insulin lispro dose data. Only measurements prior to rescue or study drug discontinuation were used.||Units/day (U/day)||Standard Error|Least Squares Mean
676658|NCT01621178|Secondary|Change From Baseline in Fasting Glucose (FG)|LS means were calculated using MMRM with the change in FG as the dependent variable and treatment, MA -region, Baseline CKD Severity, week, treatment*week, baseline FG, baseline HbA1c (%), log baseline eGFR (within CKD severity), and participant was the random effect. Covariance structure = Unstructured|Baseline, 26 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline HbA1c and FG data. Only measurements prior to rescue or study drug discontinuation were used.||milligram/deciliter (mg/dL)||Standard Deviation|Least Squares Mean
676659|NCT01621178|Secondary|Change From Baseline in 8-Point Self-Monitored Plasma Glucose (SMPG)|The daily mean of 8-point SMPG profile at Week 26 is presented. Participants were required to perform two 8-point SMPG profiles over a 1-week period at 5 separate times throughout the study. LS means were calculated using the MMRM model including the corresponding baseline value as a continuous covariate, as well as baseline HbA1c, MA-region, treatment, week, treatment*week, baseline CKD severity, and log baseline eGFR (within CKD severity).The two 8-point SMPG profiles were collected on two non-consecutive days (pre-meal and 2-hour postprandial SMPG x [morning, midday, and evening meals in one day] + bedtime + 5 hours after bedtime).|Baseline, 26 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline HbA1c and SMPG data. Only measurements prior to rescue or study drug discontinuation were used.||milligrams/deciliter (mg/dL)||Standard Error|Least Squares Mean
676660|NCT01621178|Secondary|Percentage of Participants Whose HbA1c Was <8.0%|Percentage of Participants whose HbA1c was <8.0% based on last observation carried forward (LOCF).|26 Weeks|All randomized participants who received at least one dose of study drug and had evaluable post-baseline HbA1c data. Only measurements prior to rescue or study drug discontinuation were used.||percentage of participants|||Number
676661|NCT01621178|Secondary|Percentage of Participants Whose HbA1c Was <7.0%|Percentage of participants whose HbA1c was <7.0% based on last observation carried forward (LOCF).|26 Weeks|All randomized participants who received at least one dose of study drug and had evaluable post-baseline HbA1c data. Only measurements prior to rescue or study drug discontinuation were used||percentage of participants|||Number
676742|NCT01618708|Secondary|Change From Baseline in Patient Global Self-Assessment (PTGA) Score Over 26 Weeks|PTGA (self-assessment of target hip osteoarthritis condition) was measured using the 11-point NRS ranging from 0 (none) to 10 (extreme), where lower score represents very well condition and higher score represents very poor condition.|From baseline to Week 26|ITT population.||units on a scale||Standard Error|Least Squares Mean
676662|NCT01621178|Primary|Change From Baseline in Hemoglobin A1c (HbA1c)|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least square (LS) means in HbA1c were calculated using a restricted maximum likelihood (REML) based mixed-effects model for repeated measures (MMRM) with the change in HbA1c as the dependent variable and treatment, macroalbuminuria (MA) region, Baseline CKD Severity, week, treatment*week, baseline HbA1c (%), log baseline eGFR (within CKD severity), and participant was the random effect. Covariance structure = Unstructured.|Baseline, 26 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline HbA1c data. Only measurements prior to rescue or study drug discontinuation were used.||percentage of HbA1c||Standard Error|Least Squares Mean
676663|NCT01621126|Primary|Neurologic Complication Rate After Latarjet Procedure|Nerve palsy of any nerve(s) in the operative upper extremity.|up to 24 weeks after the procedure|||participants|||Number
676664|NCT01621009|Primary|7-day Point Prevalence Abstinence From Smoking at 6 Months|No smoking, not even a puff, during the 7 days prior to the 6 month follow-up. Biochemically confirmed.|6 months|Full intent-to-treat sample||Number of abstinent participants|||Number
676665|NCT01620489|Secondary|Estimated Mean Ratio to Baseline and Observed Coefficient of Variation in Renal Function-estimated Glomerular Filtration Rate (eGFR) (to Check How Well the Kidneys Are Functioning Using Modification of Diet in Renal Disease (MDRD) Formula)|Calculated as the estimated ratio to baseline in eGFR (mL/min/1.73m˄2) after 26 Weeks of treatment based on the statistical model.|Week 0, week 26|Safety analysis set included all subjects receiving at least one dose of the trial product. A total of 8 subjects in the safety analysis set did not contribute to the analysis due to missing data.||mL/min/1.73m˄2||Geometric Coefficient of Variation|Geometric Mean
676666|NCT01620489|Secondary|Estimated Mean From the Statistical Model and Standard Deviation From Observed Data For Change From Baseline to Week 26 in Body Mass Index (BMI)|Calculated as estimated mean change in BMI (kg/m˄2) from baseline to Week 26 based on the statistical model.|Week 0, week 26|The FAS included all randomised subjects that received at least one dose of study medication. A total of 14 subjects in the FAS did not contribute to the analysis due to missing data.||kg/m^2||Standard Deviation|Mean
676667|NCT01620489|Secondary|Estimated Mean From the Statistical Model and Standard Deviation From Observed Data For Change From Baseline to Week 26 in Self-measured Plasma Glucose (SMPG) 7-point Profiles|SMPG was measured before and 90 minutes after breakfast, lunch and dinner and at bedtime at Week 0, 12 and 26. A summary measure of the 7 values was derived for each applicable visit as the area under the curve divided by the period of time elapsed between the first and last measurement. The change from baseline to week 26 was estimated using the statistical model.|Week 0, week 26|The FAS included all randomised subjects that received at least one dose of study medication. A total of 46 subjects in the FAS did not contribute to the analysis due to missing data.||mmol/L||Standard Deviation|Mean
676668|NCT01620489|Secondary|Estimated Proportion of Responders Achieving HbA1c <7.0% and no Minor or Severe Hypoglycaemic Episodes After 26 Weeks of Treatment|Calculated as estimated percentage of subjects achieving HbA1c <7.0% and no minor or severe hypoglycaemic episodes observed within 26 weeks of treatment based on the statistical model.|At week 26|The FAS included all randomised subjects that received at least one dose of study medication. A total of 14 subjects in the FAS did not contribute to the analysis due to missing data.||percentage of patients|||Number
676669|NCT01620489|Secondary|Estimated Proportion of Responders Achieving HbA1c <7.0% and no Weight Gain After 26 Weeks of Treatment|Calculated as estimated percentage of subjects achieving HbA1c <7.0% and no weight gain after 26 weeks of treatment based on the statistical model.|At week 26|The FAS included all randomised subjects that received at least one dose of study medication. A total of 14 subjects in the FAS did not contribute to the analysis due to missing data.||percentage of patients|||Number
676670|NCT01620489|Primary|Estimated Mean From the Statistical Model and Standard Deviation From Observed Data For Change From Baseline to Week 26 in HbA1c (%) (Glycosylated Haemoglobin)|Calculated as the estimated mean change from baseline in HbA1c (%) after 26 Weeks of treatment based on the statistical model.|Week 0, Week 26|The full analysis set (FAS) included all randomised subjects that received at least one dose of the study medication. A total of 14 subjects in the FAS did not contribute to the analysis due to missing data.||percentage (%)||Standard Deviation|Mean
676671|NCT01620255|Secondary|Maximum Serum PF-00547659 Concentration Achieved||Weeks 0 (baseline), 2, 4,8, 12, 16, 20, 24, 28, 32, and 36; Early Withdrawal|Participants who received active treatment (PF-00547659) were included in this analysis.||nanograms (ng)/milliliter (mL)||Standard Deviation|Mean
676672|NCT01620255|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs During the Treatment Period (Weeks 0-12)|An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. TEAEs are defined as newly occurring AEs or those worsening after first dose. AEs comprised both SAEs and non-SAEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Screening through to end of treatment period, up to 12 weeks|All randomized participants who received at least 1 dose of study treatment.||participants|||Number
676673|NCT01620255|Secondary|Percentage of Participants With an Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score of More Than or Equal to (>=) 170 at Week 12|IBDQ: Psychometrically validated PRO instrument for measuring disease-specific QOL in participants with inflammatory bowel disease. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). Total score is sum of each item score, ranged from 32 to 224 with higher score indicating better QOL. Positive change in total score indicated improvement in QOL. A score of >=170 corresponds to clinical remission.|Week 12|The primary analysis population was based on an mITT analysis set, which was defined as all randomized participants who received at least 1 dose of randomized treatment.||percentage of participants||90% Confidence Interval|Number
676743|NCT01618708|Secondary|Change From Baseline in WOMAC A Score Over 26 Weeks|WOMAC NRS 3.1 questionnaire is a health status measure questionnaire of 24 questions comprising 3 subscales (pain, stiffness and physical function). WOMAC A (measure of pain) was measured on 11-point NRS ranging from 0 (none) to 10 (extreme), where lower score represents lower pain and higher score represents higher pain.|From Baseline to Week 26|ITT population.||units on a scale||Standard Error|Least Squares Mean
676674|NCT01620255|Secondary|Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 12|IBDQ: Psychometrically validated PRO instrument for measuring disease-specific QOL in participants with inflammatory bowel disease. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). Total score is the sum of each item score, ranged from 32 to 224 with higher score indicating better QOL. Positive change in total score indicated improvement in QOL. There are 4 individual domains under the IBDQ: bowel function (fx)/symptoms (score range of 10-70), systemic symptoms (score range of 5-35), emotional status/fx (score range of 12-84), and social fx (score range of 5-35). As with total score, higher scores indicate better QOL in that domain.|Baseline (BL), Week 12|The primary analysis population was based on an mITT analysis set, which was defined as all randomized participants who received at least 1 dose of randomized treatment. n=number of evaluable participants at the specified time point for that specific domain.||units on a scale||Standard Deviation|Mean
676675|NCT01620255|Secondary|Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 12|IBDQ: Psychometrically validated patient reported outcome (PRO) instrument for measuring disease-specific quality of life (QOL) in participants with inflammatory bowel disease. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). Total score is the sum of each item score, ranged from 32 to 224 with higher score indicating better QOL. Positive change in total score indicated improvement in QOL.|Baseline, Week 12|The primary analysis population was based on an mITT analysis set, which was defined as all randomized participants who received at least 1 dose of randomized treatment. n=number of evaluable participants at the specified time point.||units on a scale||Standard Deviation|Mean
676676|NCT01620255|Secondary|Percent Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Weeks 4, 8, and 12|hsCRP was one of the PD biomarkers of the study.|Baseline; Weeks 4, 8, and 12|The primary analysis population was based on an mITT analysis set, which was defined as all randomized participants who received at least 1 dose of randomized treatment. n=number of evaluable participants at that specific time point.||percent change||90% Confidence Interval|Geometric Mean
676677|NCT01620255|Secondary|Percent Change From Baseline in Fecal Calprotectin at Weeks 4, 8, and 12|Fecal calprotectin was one of the pharmacodynamic (PD) biomarkers of the study.|Baseline, Weeks 4, 8, and 12|The primary analysis population was based on an mITT analysis set, which was defined as all randomized participants who received at least 1 dose of randomized treatment. n=number of evaluable participants at that specific time point.||percent change||90% Confidence Interval|Geometric Mean
676678|NCT01620255|Secondary|Percentage of Participants With Change From Baseline in Individual Mayo Subscore - Findings on Flexible Sigmoidoscopy - at Week 12|The Mayo Score is a tool designed to measure disease activity for UC. Scoring ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, PGA, findings on flexible sigmoidoscopy), each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopic readings from the local and the central reader were considered for analysis. The central reading was used as the primary analysis and the local readings were used for the sensitivity analyses. Changes from baseline in the subscore of <0, 0, and >0 corresponded to improvement (imp), no change (NC), and worsening (wors) in that specific subscore.|Baseline, Week 12|The primary analysis population was based on an mITT analysis set, which was defined as all randomized participants who received at least 1 dose of randomized treatment. n=number of evaluable participants at Week 12.||percentage of participants|||Number
676679|NCT01620255|Secondary|Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12|The Mayo Score is a tool designed to measure disease activity for UC. Scoring ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, PGA, findings on flexible sigmoidoscopy), each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopic readings from the local and the central reader were considered for analysis. The central reading was used as the primary analysis and the local readings were used for the sensitivity analyses. Changes from baseline in the subscore of less than (<) 0, 0, and >0 corresponded to improvement (imp), no change (NC), and worsening (wors) in that specific subscore.|Baseline; Weeks (W) 4, 8, and 12|The primary analysis population was based on an mITT analysis set, which was defined as all randomized participants who received at least 1 dose of randomized treatment. n=number of evaluable participants at that specific time point for that endpoint.||percentage of participants|||Number
676680|NCT01620255|Secondary|Change From Baseline in Total Mayo Score at Week 12|The Mayo Score is a tool designed to measure disease activity for UC. Scoring ranges from 0 to 12 points and consists of 4 subscores, each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopic readings from the local and the central reader were considered for analysis. The central reading was used as the primary analysis and the local readings were used for the sensitivity analyses.|Baseline, Week 12|The primary analysis population was based on an mITT analysis set, which was defined as all randomized participants who received at least 1 dose of randomized treatment. n=number of evaluable participants in that specified category.||units on a scale||Standard Deviation|Mean
676681|NCT01620255|Secondary|Percentage of Participants With Absolute Partial Mayo Score of Less Than or Equal to (<=) 2 With no Individual Subscore More Than (>) 1 at Weeks 4, 8, and 12|"An absolute Partial Mayo Score of <=2 corresponds to remission. However, this endpoint was incorrectly stated in the protocol and instead of absolute Partial Mayo Score <=2, it was stated as change from baseline in Partial Mayo Score <=2."|Weeks 4, 8, and 12|As this endpoint was incorrectly stated in the protocol, no analyses were done and no data are presented.|||||
676682|NCT01620255|Secondary|Percentage of Participants With Mucosal Healing at Week 12|Mucosal healing was defined as absolute Mayo subscore for endoscopy of 0 or 1. The Mayo Score is a tool designed to measure disease activity for UC. Scoring ranges from 0 to 12 points and consists of 4 subscores, each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopic readings from the local and the central reader were considered for analysis. The central reading was used as the primary analysis and the local readings were used for the sensitivity analyses.|Week 12|The primary analysis population was based on an mITT analysis set, which was defined as all randomized participants who received at least 1 dose of randomized treatment.||percentage of participants||90% Confidence Interval|Number
676927|NCT01615822|Secondary|MQ Cmax|Peak Plasma Concentration (Cmax) of MQ|Up to 42 days post-dose|Only the subjects who completed all treatments in their respective cohort (per-protocol set) were included in the PK population.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
676683|NCT01620255|Secondary|Percentage of Participants With Clinical Response at Week 12|Clinical response was defined as a decrease from baseline of at least 3 points in Total Mayo Score with at least a 30 percent (%) change, accompanied by at least 1 point decrease or absolute score of 0 or 1 in rectal bleeding subscore. The Mayo Score is a tool designed to measure disease activity for UC. Scoring ranges from 0 to 12 points and consists of 4 subscores, each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopic readings from the local and the central reader were considered for analysis. The central reading was used as the primary analysis and the local readings were used for the sensitivity analyses.|Week 12|The primary analysis population was based on an mITT analysis set, which was defined as all randomized participants who received at least 1 dose of randomized treatment. n=number of participants evaluable for the specified category.||percentage of participants||90% Confidence Interval|Number
676684|NCT01620255|Primary|Percentage of Participants in Clinical Remission at Week 12|Clinical remission was defined as a Total Mayo Score of less than or equal (<=) 2 points with no individual subscore exceeding 1 point and rectal bleed subscore of 0 or 1. The Mayo Score is a tool designed to measure disease activity for ulcerative colitis (UC). Scoring ranges from 0 to 12 points and consists of 4 subscores, each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopic readings from the local and the central reader were considered for analysis. The central reading was used as the primary analysis and the local readings were used for the sensitivity analyses.|Week 12|The primary analysis population was based on a modified intent-to-treat (mITT) analysis set, which was defined as all randomized participants who received at least 1 dose of randomized treatment. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.||percentage of participants||90% Confidence Interval|Number
676685|NCT01620177|Secondary|THC Concentration Levels in Whole Blood|Measurement of THC concentration levels in whole blood over the course of each visit compared to that of the other visits.|-0.7 hr, 0.25hr, 1.1 hr, 2 hr, 3 hr, 4.5 hr, 6 hr, 8 hr post cannabis|||ng/ml||Full Range|Median
676686|NCT01620177|Secondary|THC Concentration in Plasma Sample|Measurement of THC concentration levels in plasma over the course of each visit compared to that of the other visits.|-0.7 hr, 0.25hr, 1.1 hr, 2 hr, 3 hr, 4.5 hr, 6 hr, 8 hr post cannabis administration|We performed noncompartmental analyses with Phoenix WinNonLin® 6.3 for Windows (Pharsight) for maximum concentration (Cmax) of 11-OH-THC (LOQ 1 μg/L).||ng/ml||Full Range|Median
676687|NCT01620177|Primary|Driving Performance|Measured by standard deviation of lane position. Metrics of driving performance were modeled using the SAS GLM Select function to identify changes in driver performance. Numbers represents coefficients on the regression equation such that this increase would be expected for every unit increase. A unit for THC is 1 ng/ml and a unit for BAC is 0.01% BAC. In understanding the regression coefficients, for THC the units for the coefficient would be expressed as cm per (ng/ml of THC), and for BrAC the units for the coefficient would be expressed as cm per (0.01% BrAC). The overall regression equation would be represented as SDLP = Intercept + Cthc x THC + Cbrac x BrAC. The coefficients indicate the strength of the effect on driving performance with higher coefficients indicating larger effects relative to the concentrations. Coefficients of zero indicate no effect or interactive effect.|Through entire drive, 0.5-1.3 hr post cannabis administration.|One subject who was an extreme outlier across driving performance measures was excluded. Due to the variability in THC and BrAC levels across subjects and conditions, a regression model was used which combined all of the data.||cm|||Number
676688|NCT01620138|Primary|Tumor Volume Changes for NFPA and Prolactin Level Changes for Prolactinoma|Magnetic resonance imaging (MRI) of the sella and prolactin will be performed before (baseline) and after 6 months of treatment with cabergoline or pasireotide. Disease progression will be defined as tumor growth > 25%, stable disease as changes < 25% and significant tumor shrinkage as > 25% in tumor volume compared to baseline MRI (baseline to six months).|Baseline to six months|||cmˆ3||Full Range|Median
676689|NCT01620086|Secondary|Depression Level Changes as Measured by the Hamilton Depression Inventory (HAMD).|HAM-D is a multiple choice questionnaire that clinicians administer to rate the severity of a subject's depression. There are 17 questions; each question has between 3-5 possible responses which increase in severity (range 0 to 52). The clinician chooses the correct response by interviewing the subject and by observing the symptoms. A score of 0-7 is considered to be normal, scores of 20 or higher indicate moderately severe depression. Change in the average results of this test between the baseline and active treatment weeks (1 and 10 Hz) will be measured.|"change between the baseline time point and 4 days of active treatment (patients) or 2 days of sham or active treatment (controls)"|Data are not collected on this outcome measure for controls. Data was missing for one patient in the active 1 Hz treatment condition.||units on a scale||Standard Deviation|Mean
676690|NCT01620086|Secondary|Overall Change in the Percent Habituation of the P50 Evoked Response Potential at 250 Inter Stimulus Interval (ISI) Between the Control and Active Treatments (1 and 10 Hz).|Percent habituation refers to change in the amplitude of the P50 evoked response potential following a 250 ms inter stimulus interval. Change in the average results of this test between the baseline and active treatment weeks (1 and 10 Hz) will be measured.|"change between the baseline time point and 4 days of active treatment (patients) or 2 days of sham or active treatment (controls)"|Three patients had missing data for the control site - baseline condition and the active 1 Hz treatment site -baseline conditions. One patient had missing data for the active 10 Hz treatment site - baseline.||percent of change in wave amplitude||Standard Deviation|Mean
676691|NCT01620086|Primary|Changes in Auditory Hallucinations Questionnaire (AHQ).|The Auditory Hallucinations Questionnaire (AHQ) will be used to determine the patient's perceptions of change in auditory hallucinations(s). Normal controls do not fill out this measure because they do not have auditory hallucinations. Change in the average results of this test between the baseline and active treatment weeks (1 and 10 Hz) will be measured. The range of scores is 0-70, higher scores mean more symptoms.|"change between the baseline time point and 4 days of active treatment (patients) or 2 days of sham or active treatment (controls)"|Data are not collected on this outcome measure for controls. Data was missing for one patient in the active 1 Hz treatment condition.||units on a scale||Standard Deviation|Mean
676692|NCT01620060|Secondary|Number of Participants With Serious Adverse Events and Non-serious Adverse Events|Serious adverse event and adverse events data will be listed and summarized as per MedDRA V15.0|11 Days|||participants|||Number
678209|NCT01600222|Primary|Change in 24-hour Urinary Calcium:Creatinine Ratio From Baseline to Day 28|The effect of LEO 90100 on calcium metabolism was evaluated based on change in urinary calcium:creatinine ratio from Baseline to Day 28.|Baseline and Day 28|||mmol/g||Standard Deviation|Mean
676694|NCT01620060|Primary|Lurasidone Primary Pharmacokinetic Parameters|Lurasidone AUClast (Day 1) and AUC0-∞ (Day 1) AUC0-24 (Day 10 or Day 12)|Day 1 - pre-dose, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, and 48 hours. Day 10/12: 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours|"Participants for PK analysis included all subjects who received at least 1 dose of study drug and had at least 1 measured concentration at a scheduled PK timepoint after start of dosing for at least 1 PK analyte.
For some PK parameters, some subjects didn't have PK data."||ng.h/mL||Standard Deviation|Mean
676695|NCT01620047|Secondary|Serum Fentanyl Levels|To identify a difference in serum fentanyl levels among the groups.|24 hours post-surgery||||||
676696|NCT01620047|Secondary|VAS Scores and Postoperative Supplemental Morphine Consumption|"Secondary Objective
To determine the amount of required supplemental analgesia during the postoperative period.
To determine postoperative analgesia using a Visual Analog Scale (VAS) 0 – 10 centimeter line."|24 hours post-surgery||||||
676697|NCT01620047|Primary|Comparison of Postoperative Strength (Extension)|To assess extension force postoperatively to discern differences in muscle strength retention between continuous femoral nerve sheath catheter administration of fentanyl or Ropivacaine or a continuous IV infusion of fentanyl.|24 hours post-surgery|Per protocol||Nm/kg||Full Range|Median
676698|NCT01619878|Secondary|Time to Gametocyte Clearance (GCT)|Time from first dose until first total and continued disappearance of gametocytes which remains at least a further 48 hours.|Up to 7 days|Full analysis set (FAS) – all subjects receiving at least one dose of study drug and who are confirmed to have P. falciparum malaria at baseline.||hours||Standard Deviation|Mean
676699|NCT01619878|Secondary|Time to Fever Clearance (FCT)|Time from first dose to the first time the axillary body temperature decreased below and remained below 37.5° C for at least 48 hours.|Up to 7 days|Full analysis set (FAS) – all subjects receiving at least one dose of study drug and who are confirmed to have P. falciparum malaria at baseline.||hours||Standard Deviation|Mean
676700|NCT01619878|Secondary|Time to Parasite Clearance (PCT)|Time from first dose until first total and continued disappearance of asexual parasite forms which remains at least a further 48 hours.|Up to 7 days|Full analysis set (FAS) – all subjects receiving at least one dose of study drug and who are confirmed to have P. falciparum malaria at baseline.||hours||Standard Deviation|Mean
676701|NCT01619878|Secondary|Number of Participants With Parasitaemia at 72 Hours After Treatment Initiation Greater Than or Equal to 25 Percent of Count at Baseline|Number of participants with parasite density at 72 hours after treatment initiation greater than or equal to 25 percent of parasite density at baseline.|72 hours|Full analysis set (FAS) – all subjects receiving at least one dose of study drug and who are confirmed to have P. falciparum malaria at baseline.||participants|||Number
676702|NCT01619878|Secondary|Number of Participants With Parasitaemia at 48 Hours After Treatment Initiation Greater Than at Baseline|Number of participants with parasite density at 48 hours after treatment initiation greater than parasite density at baseline.|48 hours|Full analysis set (FAS) – all subjects receiving at least one dose of study drug and who are confirmed to have P. falciparum malaria at baseline.||participants|||Number
676703|NCT01619878|Secondary|Percent Change of Parasite Count From Baseline at 24 Hours|Percent change of parasite count from baseline at 24 hours|baseline, 24 hours|Full analysis set (FAS) – all subjects receiving at least one dose of study drug and who are confirmed to have P. falciparum malaria at baseline.||Percent Change||Standard Deviation|Mean
676704|NCT01619878|Secondary|Number of Participants With Parasitological Uncorrected Cure Rate at Day 3, 7, 14, 28 and 42|Number of patients with clearance of asexual parasites at day 3, 7, 14, 28 and 42 after initiating study treatment.|Day 3, 7, 14, 28 and 42|Full analysis set (FAS) – all subjects receiving at least one dose of study drug and who are confirmed to have P. falciparum malaria at baseline.||participants|||Number
676705|NCT01619878|Secondary|Polymerase Chain Reaction (PCR) Corrected Parasitological Cure Rate at Day 14 and 42|Number of participants with clearance of asexual parasites by day 7 after initiating study treatment without recrudescence at day 14 and day 42, corrected for re-infection by Polymerase Chain Reaction (PCR) assay.|Day 14 and 42|Full analysis set (FAS) – all subjects receiving at least one dose of study drug and who are confirmed to have P. falciparum malaria at baseline.||Number of participants|||Number
676706|NCT01619878|Primary|Polymerase Chain Reaction (PCR) Corrected 28 Day Parasitological Cure Rate|Number of participants with clearance of asexual parasites by day 7 after initiating study treatment without recrudescence at day 28, corrected for re-infection by Polymerase Chain Reaction (PCR) assay.|28 days|Full analysis set (FAS) – all subjects receiving at least one dose of study drug and who are confirmed to have P. falciparum malaria at baseline.||number of participants|||Number
676707|NCT01619800|Primary|Changed in Stress Test at 6 Months as Compared to Baseline|An Exercise or Dobumatime Stress Test to be performed to assess primary outcome measure.|baseline and 6 months||||||
676708|NCT01619787|Primary|Change in Energy Purchased as a Result of Subsidies|Change in total calories as a result of subsidies of 12.5% and 25%.|Study Completion|Data is reported for 199 participants. Out of 217 participants who started the study, 5 participants were lost to follow up, 1 participant shopped in the same store twice, 2 participants had conditions that would affect shopping, 2 participants did not report minority status and 8 male participants were excluded due to the small sample number.||Total Calories Purchased||Standard Error|Least Squares Mean
676709|NCT01619787|Primary|Change in Energy Purchased as a Result of Taxes.|Change in total calories as a result of taxes of 12.5% and 25%.|Study Completion|Data is reported for 199 participants. Out of 217 participants who started the study, 5 participants were lost to follow up, 1 participant shopped in the same store twice, 2 participants had conditions that would affect shopping, 2 participants did not report minority status and 8 male participants were excluded due to the small sample number.||Total Calories Purchased||Standard Error|Least Squares Mean
676710|NCT01619774|Secondary|Progression-Free Survival (PFS)|Duration of response defined for subjects with a confirmed complete response (CR) or partial response (PR), as time from the first documented evidence of a CR or PR until the first documented disease progression or death due to any cause. Progression free survival (PFS) estimated and summarized using the method of Kaplan and Meier.|Evaluation every 8 weeks (2 cycles) up to 12 months|Three of the 23 participants were not evaluable for response therefore not included PFS analysis.||weeks||95% Confidence Interval|Median
676711|NCT01619774|Primary|Number of Participants by Response|Clinical responses evaluated using RECIST 1.1 criteria after every 2 cycles (8 weeks). Complete Response (CR): Disappearance all lesions; pathological lymph nodes reduction in short axis to <10 mm. Partial Response (PR): >30% decrease in sum diameters of lesions, reference baseline sum diameters. Progressive Disease (PD): >20% increase in sum diameters of lesions, reference smallest sum on study (includes baseline sum if smallest on study); relative increase of 20%, sum must also demonstrate absolute increase of >5 mm; appearance of 1 or > new lesions considered progression). Stable Disease (SD): Neither sufficient shrinkage for PR nor sufficient increase for PD, reference smallest sum diameters while on study.|Evaluation every 8 weeks (2 cycles) up to 12 months|||participants|||Number
676712|NCT01619774|Primary|Overall Response Rate (ORR)|"Overall response rate defined as percentage of subjects with a confirmed complete response (CR) or a partial response (PR) at any time as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Clinical responses will be evaluated using RECIST 1.1 criteria after every 2 cycles (8 weeks).
Complete Response (CR): Disappearance all lesions; pathological lymph nodes reduction in short axis to <10 mm. Partial Response (PR): >30% decrease in sum diameters of lesions, reference baseline sum diameters. Progressive Disease (PD): >20% increase in sum diameters of lesions, reference smallest sum on study (includes baseline sum if smallest on study); relative increase of 20%, sum must also demonstrate absolute increase of >5 mm; appearance of 1 or > new lesions considered progression). Stable Disease (SD): Neither sufficient shrinkage for PR nor sufficient increase for PD, reference smallest sum diameters while on study."|Evaluation every 8 weeks (2 cycles) up to 12 months|Three of the 23 participants were not evaluable for response.||Percentage of Participants|||Number
676713|NCT01619579|Primary|Symptom Severity (SS) Score After 4 Weeks Treatment|"Symptom Severity (SS) Score Range is 0 to 12. 0 = Lowest pain score (Best Outcome). 12 = Highest pain score (Worst Outcome).
The SS scale identifies the level of severity sum of 4 categories (Fatigue, Waking Unrefreshed, Cognitive Symptoms, Somatic Symptoms) over the past week, using this scale:
0 = no problem
slight or mild
moderate
severe: continuous, life-disturbing"|4 Weeks|Enrolled population was diagnosed with FMS according to the 2010 ACR diagnostic criteria. Three participants withdrew from the study for personal reasons and their post-therapy data were not obtained.||units on a scale||Full Range|Mean
676714|NCT01619579|Primary|Tender Point Count (TPC) After 4 Weeks Treatment|"Tender Point Count (TPC) Score Range is 0 to 18. 0 = Lowest pain score (Best Outcome). 18 = Highest pain score (Worst Outcome). The criteria required confirming tenderness used 4kg of pressure applied to a total of 18 specified tender point sites.
Fibromyalgia is diagnosed with a minimum tenderness count in 11 of 18 points."|4 Weeks|Enrolled population was diagnosed with FMS according to the 2010 ACR diagnostic criteria. Three participants withdrew from the study for personal reasons and their post-therapy data were not obtained.||units on a scale||Full Range|Mean
676715|NCT01619579|Primary|Widespread Pain Index (WPI) Score After 4 Weeks Treatment|Widespread Pain Index (WPI) Score Range is 0 to 19 points. 0 = Lowest pain score (Best Outcome). 19 = Highest pain score (Worst Outcome). Widespread pain was defined as pain occurring in at least 2 contralateral body quadrants, in addition to the axial skeleton for at least 3 consecutive months.|4 Weeks|Enrolled population was diagnosed with FMS according to the 2010 ACR diagnostic criteria. Three participants withdrew from the study for personal reasons and their post-therapy data were not obtained.||units on a scale||Full Range|Mean
676716|NCT01619059|Secondary|Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])|Therapeutic glycemic response is defined as HbA1c <7.0%. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.|From Baseline to Week 24|All randomized participants who received study medication and were not missing baseline and Week 24 (LOCF) values||Percent of participants||95% Confidence Interval|Number
676717|NCT01619059|Secondary|Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 24|Baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained at Week 24 in the double-blind period, including observations prior to rescue.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing FPG values at baseline and Week 24||mg/dL||Standard Error|Mean
676718|NCT01619059|Secondary|Adjusted Mean Change From Baseline in 2-hour Post Prandial Glucose (PPG) From a Liquid Meal Tolerance Test (MTT) at Week 24|Baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. PPG measurements were obtained at Week 24 in the double-blind period, including observations prior to rescue.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing PPG values at baseline and Week 24||mg/dL||Standard Error|Mean
676719|NCT01619059|Primary|Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24|HbA1c was measured as percent of hemoglobin by a central laboratory. Baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained at Week 24 in the double-blind period, including observations prior to rescue.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing HbA1c values at baseline and Week 24||Percent of glycosylated haemoglobin||Standard Error|Mean
676720|NCT01618968|Primary|Dose-Normalized Cmax for MTX|Dose-normalized maximum observed concentration (Cmax) for each treatment|24 Hour period|The Population was defined as all randomized subjects who received at least 1 dose of study drug and who had at least 1 valid post-dose plasma concentration value.||ng/mL/mg||Standard Deviation|Mean
676721|NCT01618968|Primary|Dose-Normalized AUC[0-24] for MTX|Dose-normalized area under the curve from time zero to 24 hours (AUC[0-24]/Dose) for each treatment|24 Hour period|The Population was defined as all randomized subjects who received at least 1 dose of study drug and who had at least 1 valid post-dose plasma concentration value.||ng*hr/mL/mg||Standard Deviation|Mean
676722|NCT01618968|Primary|Dose-Normalized AUC[0-Inf] for MTX|Dose-normalized area under the curve from time zero to infinity (AUC[0-inf]/Dose) for each treatment|24 Hour period|The Population was defined as all randomized subjects who received at least 1 dose of study drug and who had at least 1 valid post-dose plasma concentration value.||ng*hr/mL/mg||Standard Deviation|Mean
676777|NCT01618214|Secondary|Change From Baseline in FPG (Fasting Plasma Glucose)||Week 0, week 20|Full analysis set (FAS) - included all randomized subjects and missing data was imputed using last observation carried forward (LOCF) where any post-randomization measurements were available. Seven subjects did not contribute to FAS due to lack of post-randomization measurements.||mmol/L||Standard Deviation|Mean
676723|NCT01618955|Secondary|Tolerance of Vibex MTX Device (Injection Site Pain Severity as Reported by Patient on VAS Scale - 0 mm = no Pain to 100 mm = Very Severe Pain)|"A total of 101 patients were included in the Safety Population, which consisted of all patients who received standardized training by site personnel and review of written instructions. And then self-administered study drug using Vibex MTX device.
Visual Analog Scale assessment of injection site pain was reported by patients on 100 mm line immediately after an injection and at 24 hours after injection."|24 hours|The safety population consisted of all subjects who received study drug and administered a successful or unsuccessful self-injection. For continuous data, summary statistics (N, mean, standard deviation, median, minimum, and maximum) were provided.||mm||Standard Deviation|Mean
676724|NCT01618955|Secondary|Safety of Vibex MTX Device|"A total of 101 patients were included in the Safety Population, which consisted of all patients who received standardized training by site personnel and review of written instructions. And then self-administered study drug using Vibex MTX device
Injection site assessments were done 0.25 hour, 1 hour, 6 hours and 24 hours after an injection and reported as the following:
Erythema - 0 = None
Erythema - 1 = Very slight, barely perceptible
Erythema - 2 = Obvious, but well defined
Erythema - 3 = Moderate to severe
Erythema - 4 = Severe"|24 hours|The safety population consisted of all subjects who received study drug and administered a successful or unsuccessful self-injection. For categorical data, counts and percentages are presented.||Percentage of Participants|||Number
676725|NCT01618955|Secondary|Reliability and Robustness of Vibex MTX Device as Well as Effectiveness of Patient Education Tools|"A total of 101 patients were included in the Safety Population, which consisted of all patients who received standardized training by site personnel and review of written instructions. And then self-administered study drug using Vibex MTX device
Ease of use Questionnaire was completed by patients immediately after self-injection
Training confirmation questionnaire was completed by patients after the training and then reviewed with PI or site coordinator"|24 hours|The safety population consisted of all subjects who received study drug and administered a successful or unsuccessful self-injection. For categorical data, percentages are presented.||Percentage of Participants|||Number
676726|NCT01618955|Primary|Safe Usability of the VIBEX MTX Device for Subcutaneous (SC) Self-injection With Methotrexate (MTX) in Adult Patients With Rheumatoid Arthritis (RA) as Demonstrated by Successful Self-Injection|"A total of 101 patients were included in the Safety Population, which consisted of all patients who received standardized training by site personnel and review of written instructions. And then self-administered study drug using Vibex MTX device.
The Assessment of Essential Tasks Questionnaire was completed by site personnel documenting a patient’s performance of essential self-injection steps, including the following:
SC self-injection was administered by the patient
SC self-injection was intentional
self-injection was administered in an appropriate location on the abdomen
patient removed cap marked “1
patient removed cap marked “2
patient held device at injection site for 3 seconds
patient confirmed that the window was obstructed"|24 hours|The safety population consisted of all subjects who received study drug and administered a successful or unsuccessful self-injection. For categorical data, percentages are presented.||Percentage of Participants|||Number
676727|NCT01618942|Primary|Pressure Pain Tolerance (PTO) With 0.01cm2 Probe|The value was calculated as a avarage value of different measurement sites|1 hour after the procedure|||kg/cm2||Standard Deviation|Mean
676728|NCT01618942|Primary|Pressure Pain Tolerance (PTO) With 0.1cm2 Probe|The value was calculated as a avarage value of different measurement sites|1 hour after the procedure|||kg/cm2||Standard Deviation|Mean
676729|NCT01618942|Primary|Pressure Pain Threshold (PPT)With 0.01 cm2 Probe|The value was calculated as a avarage value of different measurement sites|1 hour after the procedure|||kg/cm2||Standard Deviation|Mean
676730|NCT01618942|Primary|Pressure Pain Threshold (PPT)With 0.1 cm2 Probe|The value was calculated as a avarage value of different measurement sites|1 hour after the procedure|||kg/cm2||Standard Deviation|Mean
676731|NCT01618942|Primary|Pressure Pain Tolerance (PTO) With 1cm2 Probe|The value was calculated as a avarage value of different measurement sites|1 hour after the procedure|||kg/cm2||Standard Deviation|Mean
676732|NCT01618942|Secondary|Measuring Values of Skinfold Thickness||10 minutes after the procedure|||millimeters||Standard Deviation|Mean
676733|NCT01618942|Secondary|Time of Each Test Procedure||10 minutes after the procedure|||seconds||Standard Deviation|Mean
676734|NCT01618942|Primary|Pressure Pain Threshold (PPT)With 1 cm2 Probe|The value was calculated as a avarage value of different measurement sites|1 hour after the procedure|||kg/cm2||Standard Deviation|Mean
676735|NCT01618864|Secondary|Reduction in Rosacea by the Study Investigator Using a Validated Scale|Data reported as percentage of participants showing improvement in rosacea scale: 4 point scale for presence of rosacea features from 0 (absent) to 3 (severe) for: flushing, nontransient erythema, papules and pustules and telangiectasia.|4, 8 weeks|Not all subjects had rosacea. 11 subjects evaluated at baseline and 4 weeks; 9 subjects evaluated at 8 weeks, since 2 subjects lost to follow-up.||percentage of participants|||Number
676736|NCT01618864|Secondary|Subject Improvement Using the Global Aesthetic Improvement (GAI) Scale|Data reported as percentage of participants showing improvement in overall score as assessed by subject. 5 point scale of 0 (no difference) to 4 (Significantly marked improvement) provided for overall improvement in skin texture, roughness, skin color (even/blotchy), erythema and photo-damage. Analogous to Outcome Measure 1.|4, 8 weeks|||percentage of participants|||Number
676737|NCT01618864|Primary|Improvement in Investigator Assessment of Overall Global Aesthetic Improvement Scale (GAI)|Data reported as percentage of participants showing improvement in overall score as assessed by investigator. 5 point scale of 0 (no difference) to 4 (Significantly marked improvement)provided for overall improvement in skin texture, roughness, skin color (even/blotchy), erythema and photo-damage.|4, 8 weeks|||percentage of participants|||Number
676738|NCT01618838|Secondary|Progression-free Survival|Progression-free survival will be defined as the time in months from study entry until progression or death. Patients who are alive and free from progression on the date of closing follow-up will be censored on that date.|7 Years||||||
676739|NCT01618838|Secondary|Proportion of Patients With Rectal Bleeding.||7 years||||||
676740|NCT01618838|Primary|Proportion of Patients With Endoscopically Detectable-telangiectasia (VRS Grade 1 or Higher).|"Telangiectasia is the primary outcome since it is a measure of tissue fribrosis (primary source of proctitis) and is a well-defined and measurable outcome.
No patients had outcome before the trial was terminated."|7 years||||||
676744|NCT01618708|Primary|Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 Subscore (Walking Pain) Over 26 Weeks|WOMAC Numerical Rating Scale (NRS) 3.1 questionnaire is a health status measure questionnaire of 24 questions comprising 3 subscales (pain, stiffness and physical function). WOMAC A1 (measure of pain during walking on a flat surface) was measured on 11-point (NRS) ranging from 0 (none) to 10 (extreme), where lower score represents lower pain and higher score represents higher pain.|From baseline to Week 26|ITT population.||units on a scale||Standard Error|Least Squares Mean
676745|NCT01618669|Secondary|Number of Participants With Adverse Events Within 24 Hours After Administration of Regadenoson|"An adverse event is considered “serious” if, in the view of either the investigator or sponsor, it results in any of the following outcomes:
Results in death,
Is life threatening,
Results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions,
Results in congenital anomaly, or birth defect,
Requires inpatient hospitalization or leads to prolongation of hospitalization
Other medically important events.
Relationship to study drug was assessed by the investigator."|Up to 24 hours after study drug administration for each stress MPI (Day 1 and Day 2-15)|Safety Analysis Set.||participants|||Number
676746|NCT01618669|Secondary|Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity|The number of cardiac segments obscured by the sub-diaphragmatic activity by group by stress SPECT MPI scan and by reader is reported.|Day 1 (stress MPI 1) and Day - 15 (stress MPI 2)|Full Analysis Set||percentage of segments|||Number
676747|NCT01618669|Secondary|Percentage of Scans With Subdiaphragmatic Interference|Each reader assessed the sub-diaphragmatic radiotracer interference with cardiac image quality using a 4-point scale of 0 = none, 1 = slight, 2 = moderate or 3 = severe for each stress SPECT MPI. The median rating across the 3 readers was used to summarize the percentage of scans with interference.|Day 1 (stress MPI 1) and Day 2 -15 (stress MPI 2)|Full Analysis Set||percentage of stress MPI scans|||Number
676748|NCT01618669|Secondary|Target to Background Radiotracer Uptake Ratios From the First and Second Stress Scans|Image quality was assessed through radiotracer uptake in the heart (target organ) compared to liver, gut and combined liver plus gut (background interference).|Day 1 (stress MPI 1) and Day 2 - 15 (stress MPI 2)|Full analysis set participants who have planar images available for each scan||ratio||Standard Deviation|Mean
676749|NCT01618669|Secondary|Overall Assessment of Image Quality|The image quality for each scan was rated by each independent reader as 1 = Poor, 2 = Fair, 3 = Good, 4 = Excellent. Based on the median rating of overall image quality across the three readers, the number of participants with each rating is reported for each scan.|Day 1 (rest MPI and stress MPI 1) and Day 2 - 15 (stress MPI 2)|Full Analysis Set||participants|||Number
676750|NCT01618669|Secondary|Participants With Less, the Same, or More Reversible Perfusion Defects Shown by the First Stress Scan When Compared to the Second Stress Scan|Each reader evaluated the initial stress SPECT MPI scan compared to the participant's second stress SPECT MPI scan (blinded at time of the evaluation) for whether there was Less (-1), the Same (0) or More (1) reversible perfusion defects. The median assessment of the 3 blinded readers was used to summarize the number of participants in each category.|Day 1 (stress MPI 1) and Day 2-15 (stress MPI 2)|Full Analysis Set||participants|||Number
676751|NCT01618669|Secondary|Proportion of Participants With Agreement in the Summed Difference Score (SDS) Between First and Second Stress Scans|"The 17-segment model for standardized myocardial segmentation was used to analyze MPI scans. At rest and stress, each segment was scored on a 0 to 4 scale according to the amount of contrast or radiotracer the myocardium in the segment absorbed:
0: normal perfusion
1: slightly reduced contrast/ uptake
2: moderately reduced contrast/uptake
3: severely reduced contrast/uptake
4: absent contrast/uptake.
SSS was calculated as the sum of the stress scores across the 17 segments and the Summed Rest Score (SRS) was calculated as the sum of the rest scores across the 17 segments. The Summed Difference Score (SDS) is the difference in the SSS and SRS (SSS – SRS).
The mean value (rounded to the nearest integer) across the 3 readers was computed and the SDS was categorized into 3 categorical variables based on the score: 0 to 6, 7 to 13 and ≥ 14. The proportion of participants with agreement in respect to these categories between the two stress scans was calculated."|Day 1 (rest MPI and stress MPI 1) and Day 2 - 15 (stress MPI 2)|Full Analysis Set||participants|||Number
676752|NCT01618669|Secondary|Proportion of Participants With Agreement in the Summed Stress Score (SSS) Between First and Second Stress Scans|"The 17-segment model for standardized myocardial segmentation was used to analyze MPI scans. Each segment was scored on a 0 to 4 scale according to the amount of contrast or radiotracer the myocardium in the segment absorbed:
0: normal perfusion
1: slightly reduced contrast/radiotracer uptake
2: moderately reduced contrast/radiotracer uptake
3: severely reduced contrast/radiotracer uptake
4: absent contrast/radiotracer uptake.
The Summed Stress Score (SSS) was calculated as the sum of the stress scores across the 17 segments. The mean value (rounded to the nearest integer) across the 3 readers was computed and the SSS was categorized into 4 group categorical variables based on the score: 0 to 3, 4 to 7, 8 to 11, and ≥ 12. The proportion of participants with agreement in respect to these categories between the two stress scans was calculated."|Day 1 (stress MPI 1) and Day 2 - 15 (stress MPI 2)|Full Analysis Set||proportion of participants|||Number
676753|NCT01618669|Secondary|Proportion of Participants With Agreement in the Assessment of Reversible Defects in 3 Categories of Ischemia Between First and Second Stress Scans|The number of segments with reversible defects was assessed by each of the 3 blinded independent expert readers. Based on the median count of the number of reversible defects across the 3 readers, categorized as 0 to 1, 2 to 4, or ≥ 5 reversible segments, the proportion of participants with agreement in the three ischemia categories between the first and second stress scans was to be calculated. In the reported data, these proportions only include the 0-1 and 2-4 categories; the ≥ 5 category was not included because there were no participants in this category for the Regadenoson Alone group for the initial stress MPI.|Day 1 (stress MPI 1) and Day 2 - 15 (stress MPI 2)|Full Analysis Set||proportion of participants||95% Confidence Interval|Number
676754|NCT01618669|Secondary|Proportion of Participants With Agreement in the Assessment of Absence or Presence of Ischemia Between First and Second Stress Scans|The number of segments with reversible defects was assessed by each of the 3 blinded independent expert readers. Based on the median count of the number of reversible defects across the 3 readers, categorized as absence (0 to 1 reversible segments) or presence (≥ 2 reversible defects) of ischemia, the proportion of participants with agreement in the presence and absence of ischemia between the first and second stress scans was calculated.|Day 1 (stress MPI 1) and Day 2 -15 (stress MPI 2)|Full Analysis Set||proportion of participants||95% Confidence Interval|Number
676755|NCT01618669|Secondary|Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events|"A clinically significant cardiac event is defined as:
Any of the following events found on the Holter electrocardiogram (ECG)/12-Lead ECG within 1 hour after regadenoson administration:
ventricular arrhythmias (sustained ventricular tachycardia, ventricular fibrillation, torsade de pointes, ventricular flutter),
ST-T depression (> 2 mm),
ST-T elevation (≥1 mm),
Atrioventricular (AV) block (2:1 AV block, AV Mobitz I, AV Mobitz II, complete heart block)
sinus arrest > 3 seconds in duration
Or
a treatment-emergent adverse event (TEAE) per the Medical Dictionary for Regulatory Activities (MedDRA) Standardised MedDRA Queries (SMQ) (Narrow Scope) for myocardial infarction
Or
a TEAE preferred term of angina unstable within 24 hours of regadenoson administration."|Within 1 hour for ECG events and up to 24 hours for adverse events after administration of regadenoson|Safety analysis set (all randomized participants who received at least 1 dose of regadenoson study drug)||percentage of participants|||Number
676756|NCT01618669|Primary|Proportion of Participants With Majority Reader Self-agreement in Ischemia Assessment Between First and Second Stress Scans|"SPECT scans were reviewed in a blinded fashion by 3 independent expert readers using the 17-segment model for standardized myocardial segmentation. At rest and stress, each segment was scored on a 0 (normal) to 4 (absent contrast/radiotracer uptake) scale by each of the 3 blinded readers according to the amount of contrast or radiotracer the myocardium in the segment absorbed. If the stress score was ≥ 2 and the rest score was less than the stress score, the segment was counted as having a reversible defect.
The number of segments with reversible defects was categorized as absence (0 - 1 reversible segments) or presence (≥ 2 defects reversible segments) of ischemia.
Each reader was defined as having self-agreement based upon identical categorization of a given participant as absent or present for ischemia for both the initial and second stress visits.
Majority agreement is if at least 2 out of the 3 blinded readers demonstrated self-agreement for a given participant."|Day 1 (rest scan and first stress scan) and Day 2 -15 (second stress scan)|Full Analysis Set||proportion of participants||95% Confidence Interval|Number
676757|NCT01618422|Primary|Number of Participants Suffering From Treatment Failure/ Relapse (Unfavourable Outcome) Among Rifampicin Resistant Group.|"Cure (Completed for 8 months or more of therapy and culture converted in the last month of treatment, and on at least one previous occasion; for multidrug resistant TB (MDR-TB) switched to definitive second line therapy per protocol in the DOTS-plus group, sustained culture conversion for at least 6 months after initiation of second line therapy and no evidence of culture reversion up to the scheduled follow-up point); Treatment failure: not culture converted at 5 months or later; Defaulted: having interrupted treatment for 2 consecutive months or more; Transfer out: having been transferred to another recording and reporting unit and for whom the treatment outcome is not known; Death: a patient who died for any reason during the course of treatment Diagnosis revised: diagnosis revised to non-tuberculous mycobacterial infection or colonisation.
Withdrawal: physician-initiated withdrawal for adverse effects, protocol violation or patient’s decision to withdraw."|18-month|||participants|||Number
676758|NCT01618266|Secondary|Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.|Baseline, Month 24|All enrolled patients||Percentage of Patients|||Number
676759|NCT01618266|Secondary|Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened.|Baseline, Week 6, Month 4, Month 12, Month 18, Month 24|All enrolled patients||Letters||Standard Deviation|Mean
676760|NCT01618266|Secondary|Change From Baseline in BCVA in the Study Eye in Patients Receiving Ozurdex® and Then Other RVO Treatments|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. Patients were previously treated with Ozurdex® and then switched to other RVO treatment during the study.|Baseline, Month 6|All enrolled patients receiving Ozurdex® and then other RVO treatments||Letters||Standard Deviation|Mean
676761|NCT01618266|Secondary|Change From Baseline in BCVA in the Study Eye in Patients Only Treated With Ozurdex®|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. Patients had only been previously treated with Ozurdex®.|Baseline, Month 6|All enrolled patients only treated with Ozurdex||Letters||Standard Deviation|Mean
676762|NCT01618266|Secondary|Change From Baseline in BCVA in the Study Eye Based on Macular Edema Onset ≥3 Months|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. The onset of macular edema was ≥3 months prior to treatment.|Baseline, Month 6|All enrolled patients with macular edema onset ≥3 months||Letters||Standard Deviation|Mean
676778|NCT01618214|Secondary|Percentage of Subjects Achieving HbA1c Below or Equal to 6.5%||After 20 weeks of treatment|Full analysis set (FAS) - included all randomized subjects and missing data was imputed using last observation carried forward (LOCF) where any post-randomization measurements were available.||percentage (%) of subjects|||Number
676763|NCT01618266|Secondary|Change From Baseline in BCVA in the Study Eye Based on Macular Edema Onset <3 Months|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. The onset of macular edema was <3 months prior to treatment.|Baseline, Month 6|All enrolled patients with macular edema onset <3 months||Letters||Standard Deviation|Mean
676764|NCT01618266|Secondary|Change From Baseline in BCVA in the Study Eye in Patients Previously Naïve to Ozurdex® Treatment|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. Patients naive to Ozurdex® have not been previously treated for retinal vein occlusion.|Baseline, Month 6|All enrolled patients previously naïve to Ozurdex® treatment||Letters||Standard Deviation|Mean
676765|NCT01618266|Secondary|Change From Baseline in BCVA in the Study Eye in Patients Previously Treated With Ozurdex®|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. Previous treatment for retinal vein occlusion was Ozurdex®.|Baseline, Month 6|All enrolled patients previously treated with Ozurdex®||Letters||Standard Deviation|Mean
676766|NCT01618266|Secondary|Change From Baseline in BCVA in the Study Eye in Previously Treatment Naïve Patients|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. Treatment naïve patients have not been previously treated for retinal vein occlusion.|Baseline, Month 6|All enrolled patients who were treatment naïve||Letters||Standard Deviation|Mean
676767|NCT01618266|Secondary|Change From Baseline in BCVA in the Study Eye Diagnosed With Central Retinal Vein Occlusion (CRVO)|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. CRVO is a blockage of the main vein in the retina.|Baseline, Month 6|All enrolled patients with CRVO||Letters||Standard Deviation|Mean
676768|NCT01618266|Secondary|Change From Baseline in BCVA in the Study Eye Diagnosed With Branch Retinal Vein Occlusion (BRVO)|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. BRVO is a blockage of the small veins in the retina.|Baseline, Month 6|All enrolled patients with BRVO||Letters||Standard Deviation|Mean
676769|NCT01618266|Primary|Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened.|Baseline, Month 6|All enrolled patients||Letters||Standard Deviation|Mean
676770|NCT01618240|Secondary|Number of Patients With Muscle Weakness (MRC<48) Who Developed Clinical Aspiration||Within 3 month follow-up|||participants|||Number
676771|NCT01618240|Primary|Muscle Strength|We use Medical Research Council (MRC) scale (0-60) to evaluate the degree of muscle weakness in the tracheostomized patients.|Within 24 hours of fiberoptic endoscopic evaluation of swallow|||participants|||Number
676772|NCT01618227|Secondary|Number of Additional Surgeries|The number of additional surgeries will be recorded and compared between groups.|6 months|||Number of Additional Surgeries|||Number
676773|NCT01618227|Secondary|Number of Physical/Occupational Therapy Visits|Number of physical/occupational therapy visits will be collected from enrollment.|6 months|||visits||Standard Deviation|Mean
676774|NCT01618227|Secondary|Wrist Range of Motion|Flexion and extension of the wrist will be measured with a goniometer in degrees, the sum of which will determine range of motion.|6 months|Two subjects had the same range of motion at 6 months, therefore SD is 0.||degrees||Standard Deviation|Mean
676775|NCT01618227|Primary|Wrist Range of Motion|Flexion and extension of the wrist will be measured with a goniometer in degrees, the sum of which will determine range of motion.|2 months|||degrees||Standard Deviation|Mean
676776|NCT01618214|Secondary|Incidence of Hypoglycaemic Episodes (All, Major, Minor and Symptoms Only)|Definition of a treatment emergent hypoglycemic episode: an episode occurred after the first administration of insulin or oral anti-diabetic drug, and no later than the last day on trial product. Severe hypoglycemic episode was that requiring assistance to administer carbohydrate, glucagon, or other resusciative actions. Minor hypoglycemic episode was the one with plasma glucose value < 3.1 mmol/L, either with symptoms that could be handled by subject, or without symptoms.|Week 0 to week 20 (inclusive).|Safety Analysis Set (SAS) included all subjects receiving at least one dose of biphasic insulin aspart 30.||events per patient per year|||Number
676780|NCT01618214|Primary|Change From Baseline in HbA1c (Glycosylated Haemoglobin)|Estimated mean change from baseline in HbA1c after 20 Weeks of treatment in full analysis set (FAS).|Week 0, week 20|Full analysis set (FAS) - included all randomised subjects and missing data was imputed using last observation carried forward (LOCF) where any post-randomisation measurements were available. Six subjects did not contribute to FAS due to lack of post-randomisation measurements.||percentage of glycosylated haemoglobin||Standard Deviation|Mean
676788|NCT01618019|Secondary|CTX Concentration|serum C-terminal telopeptide of type 1 collagen concentration as nmol/L|16 week|Per-protocol analysis (except for drop out patients) serum C-terminal telopeptide of type 1 collagen concentration at 16 week||nmol/L||Standard Error|Mean
676789|NCT01618019|Secondary|BSAP Concentration|serum bone specific alkaline phosphatase concentration as U/L|16 week|Per-protocol analysis (except for drop out patients) serum bone specific alkaline phosphatase concentration at 16 week||U/L||Standard Deviation|Mean
676790|NCT01618019|Secondary|Osteocalcin Concentration|serum Osteocalcin concentration as nmol/L|16 week|Per-protocol anlysis (except for drop out patients) serum Osteocalcain concentration at 16 week||nmol/L||Standard Deviation|Mean
676791|NCT01618019|Secondary|Pain Scale|Pain scale is ranged from 0 to 100. (0= no pain; 100= severe pain)|16 week|Per-protocol analysis (except for drop out patients) Measurement of Pain scale at 16 week.||units on a scale||Standard Deviation|Mean
676792|NCT01618019|Secondary|Patient’s Global Assessment|Patient’s global assessment is patient self-assessed disability. (0= better condition; 10= very worse condition)|16 week|Per-protocol analysis (except for drop out patients) Measurement of Patient’s global assessment at 16 week.||units on a scale||Standard Deviation|Mean
676793|NCT01618019|Secondary|Physician’s Global Assessment|"Physician’s global assessment is ranged from 0 to 10 by the assessing physician.
(0= no pain; 10= very severe pain)"|16 week|Per-protocol analysis (except for drop out patients) Measurement of Physician’s global assessment at 16 weeks.||units on a scale||Standard Deviation|Mean
676794|NCT01618019|Secondary|Duration of Morning Stiffness|Duration of morning stiffness means that patients with rheumatoid arthritis feel those joints stiff when they wake up in the morning.|16 week|Per-protocol analysis (except for drop out patients) Measurement of Morning stiffness assessment at 16 weeks, except for 16 in N-3 PUFA and 16 in placebo||minutes||Standard Deviation|Mean
676795|NCT01618019|Primary|Dose of NSAID|Daily non-steroidal anti-inflammatory drug (NSAID) requirements as mg/day|16 week|Per-protocol analysis (except for drop out patients) Measurement of NSAID requirements at 16 weeks, except for 10 in N-3 PUFA and 6 in placebo.||mg||Standard Deviation|Mean
676796|NCT01617681|Secondary|CKD Patients Achieving Urine Albumin Creatinine Ratio Percentage Reduction (UACR) >=25% at Week 6|UACR response is defined as percentage change from baseline in UACR≤ 25%. UACR [mg/mmol] = urine albumin [mg/L] / urine creatinine [mmol/L] UACR was collected for CKD patients only. The UACR value at a given visit for a patient was to be derived by the median of the three lab values collected for that visit Week 6.|Week 6 weeks|Full analysis set (FAS) included all randomized patient except for 1 patient that guardian did not sign informed consent - CKD patients only The number of patients with an UACR at baseline and week 6 endpoint (included in the analysis).||participants|||Number
676797|NCT01617681|Secondary|Patients Achieving <90th Percentile for Age, Gender and Height at Week 6 Endpoint in Both MSBP and MDBP|Patient’s blood pressure will be measured in the same position at every visit Systolic and diastolic blood pressures will be measured three times at 2-3 minute intervals. The arithmetic mean of these three blood pressure measurements will be used as the mean office blood pressure (MSBP and MDBP) Week 6|Week 6|Full analysis set (FAS) included all randomized patient except for 1 patient that guardian did not sign informed consent||participants|||Number
676798|NCT01617681|Secondary|Change From Baseline in Mean Diastolic Blood Pressure (MDBP) at Week 6|Patient’s blood pressure will be measured in the same position at every visit Systolic and diastolic blood pressures will be measured three times at 2-3 minute intervals. The arithmetic mean of these three blood pressure measurements will be used as the mean office blood pressure (MSBP and MDBP) Baseline and Week 6 endpoint in Period 1 Double Blind Phase|Baseline, Week 6|Full analysis set (FAS) included all randomized patient except for 1 patient that guardian did not sign informed consent||mmHg||Standard Error|Least Squares Mean
676799|NCT01617681|Primary|Change From Baseline in Mean Systolic Blood Pressure (MSBP) at Week 6 Endpoint|Patient’s blood pressure will be measured in the same position at every visit Systolic and diastolic blood pressures will be measured three times at 2-3 minute intervals. The arithmetic mean of these three blood pressure measurements will be used as the mean office blood pressure (MSBP and MDBP) at Baseline and Week 6 endpoint in Period 1 Double Blind Phase|Baseline, week 6|Full analysis set (FAS) included all randomized patient except for 1 patient that guardian did not sign informed consent||mmHg||Standard Error|Least Squares Mean
676800|NCT01617668|Secondary|Pharmacokinetics (PK) Parameters of LCL161 Only for AUClast|To evaluate the PK of LCL161 when given in combination with paclitaxel|cycle 1 day 1, cycle 4 day 15|The pharmacokinetic analysis set (PAS) consisted of all patients who had at least one blood sample providing evaluable PK data for LCL161. Only sparse/limited PK samples were collected and analyzed.||ng*hr/mL||Full Range|Median
676801|NCT01617668|Secondary|Pharmacokinetics (PK) Parameters of LCL161 Only for Tmax|To evaluate the PK of LCL161 when given in combination with paclitaxel. The pharmacokinetic analysis set (PAS) consisted of all patients who had at least one blood sample providing evaluable PK data for LCL161.|cycle 1 day 1, cycle 4 day 15|The pharmacokinetic analysis set (PAS) consisted of all patients who had at least one blood sample providing evaluable PK data for LCL161. Only sparse/limited PK samples were collected and analyzed.||h||Full Range|Median
676802|NCT01617668|Secondary|Pharmacokinetics (PK) Parameters of LCL161 Only for Cmax|To evaluate the PK of LCL161 when given in combination with paclitaxel.|cycle 1 day 1, cycle 4 day 15|The pharmacokinetic analysis set (PAS) consisted of all patients who had at least one blood sample providing evaluable PK data for LCL161. Only sparse/limited PK samples were collected and analyzed.||ng/mL||Full Range|Median
676803|NCT01617668|Secondary|Caspase 3 Activation in Tumor by Immunohistochemistry (IHC) - EAS2|To evaluate whether combination treatment with LCL161 and paclitaxel is associated with increased apoptosis compared to weekly paclitaxel alone. To evaluate whether combination treatment with LCL161 and paclitaxel was associated with increased apoptosis compared to weekly paclitaxel alone, cleaved caspase 3 activation in tumor by IHC was examined. Cycle = 28 days; each patient had either C1D2 or C1D9|Baseline, Post-baeline at Cycle 1, Day 2 or Cycle 1, Day 9|The Efficacy Analysis Set 2 (EAS2) was the same as EAS1 except that the threshold for classifying a patient into the positive gene group was 0.7716. All the EAS2 set participants were considered for the analysis (N). Only participants (n) who had baseline and post baseline values for the given time point were analyzed for that time point.||% of positive tumor cells||Standard Deviation|Mean
676804|NCT01617668|Secondary|Caspase 3 Activation in Tumor by Immunohistochemistry (IHC) - EAS1|"To evaluate whether combination treatment with LCL161 and paclitaxel is associated with increased apoptosis compared to weekly paclitaxel alone. To evaluate whether combination treatment with LCL161 and paclitaxel was associated with increased apoptosis compared to weekly paclitaxel alone, cleaved caspase 3 activation in tumor by IHC was examined.
Gene expression signature status is derived based on continuous gene expression signature score using cut-off 0.6661 (positive: score ≥ 0.6661; negative: score <0.6661); cycle = 28 days; each patient had either C1D2 or C1D9"|Baseline, Post-baeline at Cycle 1, Day 2 (C1D2) or Cycle 1, Day 9 (C1D9)|Efficacy Analysis Set 1 (EAS1) is patients (pts) who received at least 1 full or partial dose of LCL161 + paclitaxel or of paclitaxel alone with valid gene expression signature score. All pts were considered for analysis (N). Only pts (n) with baseline & post baseline values for the given time point were analyzed for that time point.||% of positive tumor cells||Standard Deviation|Mean
676805|NCT01617668|Secondary|Rates of Breast Conserving Surgery and Mastectomy - Assessed by Percentage of Patients Who Underwent Breast Conserving Surgery, Masectomy and no Surgery|To assess other indicators of disease response for the LCL161 + paclitaxel combination compared to paclitaxel alone. Rates of breast conserving surgery and mastectomy also contributed to the overall assessment of disease response and were summarized by treatment arm within each gene expression signature status. For this analysis, patients with multicentric breast cancer were excluded, as all patients in this group were expected to be treated with mastectomy.|16 weeks|EAS1 - patients receiving at least 1 full or partial dose of LCL161 + paclitaxel or of paclitaxel alone with a valid gene expression signature (GES) score. GES status is derived based on continuous GES score using cut-off 0.6661(pos: score ≥ 0.6661; neg: score <0.6661). Patients with multicentric breast cancer were excluded.||Percentage of participants|||Number
676806|NCT01617668|Secondary|pCR Rate in Breast, Regional Nodes and Axilla|To assess other indicators of disease response for the LCL161 + paclitaxel combination compared to paclitaxel alone. The pCR in breast, regional nodes, and axilla were determined based on the America Joint Committee on Cancer Staging [AJCC] stages T1c, T2, N0-N2, M0) were (AJCC) pathologic staging recorded on the eCRF: a patient was considered to be a responder in breast, regional nodes, and axilla if the pathological complete response was reported for breast and if the regional lymph nodes staging was pN0 (including i-, mol-, mol+).The measurement type used for this analysis is posterior median and the method of dispersion is Credible Interval (Crl) and not Confidence Interval (CI). 95% Confidence interval is actually 95% credible interval.|12 weeks|Efficacy Analysis Set 1 (EAS1) are patients who received at least 1 full or partial dose of LCL161 + paclitaxel or of paclitaxel alone with a valid gene expression signature score. Gene expression signature status is derived based on continuous gene expression signature score using cut-off 0.6661(positive: score ≥ 0.6661; negative: score <0.6661)||Percentage of participants||95% Confidence Interval|Median
676807|NCT01617668|Secondary|pCR Rate in Breast After 12 Weeks of Therapy With Single Agent LCL161 and LCL161 + Paclitaxel, Regardless of Gene Signature Status|To assess whether adding LCL161 to weekly paclitaxel enhances the efficacy of paclitaxel in women with triple negative breast cancer regardless of tumor gene expression signature status. This comparison is between the 2 study treatments, regardless of gene signature status. The measurement type used for this analysis is posterior median and the method of dispersion is Credible Interval (Crl) and not Confidence Interval (CI). 95% Confidence interval is actually 95% credible interval.|12 weeks|Efficacy Analysis Set 1 (EAS1) are patients who received at least 1 full or partial dose of LCL161 + paclitaxel or of paclitaxel alone with a valid gene expression signature score. Gene expression signature status is derived based on continuous gene expression signature score using cut-off 0.6661(positive: score ≥ 0.6661; negative: score <0.6661)||Percentage of participants||95% Confidence Interval|Median
676928|NCT01615822|Secondary|MQ AUC0-t|Area under the plasma concentration versus time curve (AUC) of MQ|Up to 42 days post-dose|Only the subjects who completed all treatments in their respective cohort (per-protocol set) were included in the PK population.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
676808|NCT01617668|Secondary|Posterior Distribution of Difference in pCR Rates After Treatment With Paclitaxel Only Between Gene Expression Positive and Negative Tumors|To assess whether use of the gene expression signature identifies tumors more likely to respond to treatment with paclitaxel only. The measurement type used for this analysis is posterior median and the method of dispersion is Credible Interval (Crl) and not Confidence Interval (CI). 95% Confidence interval is actually 95% credible interval.|12 weeks|Efficacy Analysis Set 1 (EAS1) are patients who received at least 1 full or partial dose of LCL161 + paclitaxel or of paclitaxel alone with a valid gene expression signature score. Gene expression signature status is derived based on continuous gene expression signature score using cut-off 0.6661(positive: score ≥ 0.6661; negative: score <0.6661)||Difference in percentage of participants||95% Confidence Interval|Median
676809|NCT01617668|Secondary|Posterior Distribution of Difference of pCR Rates After Treatment With LCL161 + Paclitaxel Between Patients With Gene Expression Positive and Negative Tumors|To assess whether use of the gene expression signature identifies tumors more likely to respond to treatment with LCL161 and paclitaxel. The measurement type used for this analysis is posterior median and the method of dispersion is Credible Interval (Crl) and not Confidence Interval (CI). 95% Confidence interval is actually 95% credible interval.|12 weeks|Efficacy Analysis Set 1 (EAS1) are patients who received at least 1 full or partial dose of LCL161 + paclitaxel or of paclitaxel alone with a valid gene expression signature score. Gene expression signature status is derived based on continuous gene expression signature score using cut-off 0.6661(positive: score ≥ 0.6661; negative: score <0.6661)||Difference in percentage of participants||95% Confidence Interval|Median
676810|NCT01617668|Primary|Difference in pCR Rates Between Treatment Arms|pCR rate was defined as histopathologically confirmed absence of invasive disease in the breast. To assess whether adding LCL161 to weekly paclitaxel enhances the efficacy of paclitaxel in women with triple negative breast cancer. Analyses were performed separately in the gene expression signature negative and positive groups. This analysis was based on the posterior distribution of the difference in pCR rates between the experimental and control arms of the study, within each gene expression signature group.The measurement type used for this analysis is posterior median and the method of dispersion is Credible Interval (Crl) and not Confidence Interval (CI). 95% Confidence interval is actually 95% credible interval.|12 weeks|FAS are patients who received at least 1 full or partial dose of LCL161 + paclitaxel or 1 full or partial dose of paclitaxel alone. These values are medians of posterior distribution of difference of pCR rate between treatment arms based on a Bayesian model. 95% Confidence interval is actually 95% credible interval.||Difference in percentage of participants||95% Confidence Interval|Median
676811|NCT01617668|Primary|Number of Participants With Pathological Complete Response (pCR) in Breast After 12 Weeks of Therapy|To assess the number of patients who experienced a pathological response in breast.|12 weeks|The Full Analysis Set (FAS) was composed of all patients who received at least one full or partial dose of LCL161 + paclitaxel or one full or partial dose of paclitaxel alone.||Participants|||Number
676812|NCT01617668|Primary|Pathological Complete Response (pCR) Rate in Breast After 12 Weeks of Therapy|pCR rate was defined as histopathologically confirmed absence of invasive disease in the breast. To assess whether adding LCL161 to weekly paclitaxel enhances the efficacy of paclitaxel in women with triple negative breast cancer. Analyses were performed separately in the gene expression signature negative and positive groups. This analysis was based on Bayesian design using a binomial distribution for the data with a beta prior. The measurement type used for this analysis is posterior median and the method of dispersion is Credible Interval (Crl) and not Confidence Interval (CI). Median values are posterior medians of pCR rate for each group.|12 weeks|The Full Analysis Set (FAS) was composed of all patients who received at least one full or partial dose of LCL161 + paclitaxel or one full or partial dose of paclitaxel alone.||Percentage of Participants||95% Confidence Interval|Median
676813|NCT01617655|Other Pre-specified|Percent Change From Baseline in Calculated LDL-C at Week 78 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 78 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 78 i.e. up to 21 days after last injection.|From Baseline to Week 78|mITT population.||percent change||Standard Error|Least Squares Mean
676814|NCT01617655|Other Pre-specified|Percent Change From Baseline in Calculated LDL-C at Week 78 - ITT Analysis|Adjusted LS means and standard errors at Week 78 from MMRM model including all available post-baseline data from Week 4 to Week 78 regardless of status on- or off-treatment.|From Baseline to Week 78|ITT population.||percent change||Standard Error|Least Squares Mean
676815|NCT01617655|Other Pre-specified|Percent Change From Baseline in Calculated LDL-C at Week 52 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 52 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 i.e. up to 21 days after last injection.|From Baseline to Week 52|mITT population.||percent change||Standard Error|Least Squares Mean
676816|NCT01617655|Secondary|Percentage of Participants Achieving Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis|Adjusted percentages at Week 24 from multiple imputation approach including available post-baseline on-treatment data from Week 4 to Week 52 i.e. up to 21 days after last injection.|Up to Week 52|mITT population.||percentage of participants|||Number
676817|NCT01617655|Secondary|Percentage of Participants Achieving Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis|Adjusted percentages at Week 24 from multiple imputation approach including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|Up to Week 52|ITT population.||percentage of participants|||Number
676818|NCT01617655|Secondary|Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|Apo A-1 ITT population.||percent change||Standard Error|Least Squares Mean
676819|NCT01617655|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|ITT population.||percent change||Standard Error|Mean
676820|NCT01617655|Secondary|Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|HDL-C ITT population.||percent change||Standard Error|Least Squares Mean
676822|NCT01617655|Secondary|Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post­baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline Apo A-1 value on-or off-treatment (Apo A-1 ITT population).||percent change||Standard Error|Least Squares Mean
676823|NCT01617655|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|ITT population.||percent change||Standard Error|Mean
676824|NCT01617655|Secondary|Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline HDL-C value on-or off-treatment (HDL-C ITT population).||percent change||Standard Error|Least Squares Mean
676825|NCT01617655|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from a multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|ITT population.||percent change||Standard Error|Mean
676826|NCT01617655|Secondary|Percentage of Very High CV Risk Participants Achieving Calculated LDL-C < 70 mg/dL (<1.81 mmol/L) or High CV Risk Participants Achieving Calculated LDL-C < 100 mg/dL (<2.59 mmol/L) at Week 24 - On-Treatment Analysis|Adjusted percentages at Week 24 from a multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 52 i.e. up to 21 days after last injection.|Up to Week 52|mITT population.||percentage of participants|||Number
676827|NCT01617655|Secondary|Percentage of Very High Cardiovascular (CV) Risk Participants Achieving Calculated LDL-C < 70 mg/dL (<1.81 mmol/L) or High CV Risk Participants Achieving Calculated LDL-C < 100 mg/dL (<2.59 mmol/L) at Week 24 - ITT Analysis|Very high CV risk participants: Heterozygous Familial Hypercholesterolemia (heFH) participants with coronary heart disease (CHD) or CHD risk equivalents. High CV risk participants: heFH participants without CHD or CHD risk equivalents. CHD risk equivalent: peripheral arterial disease, ischemic stroke, moderate chronic kidney disease (estimated glomerular filtration rate, 30 to <60 ml/minute/1.73 m^2 of body-surface area), or diabetes mellitus plus 2 or more additional risk factors (hypertension; ankle-brachial index of ≤0.90; microalbuminuria, macroalbuminuria, or a urinary dipstick result of >2+ protein; preproliferative or proliferative retinopathy or laser treatment for retinopathy; or a family history of premature CHD). Adjusted percentages at Week 24 were obtained from a multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were included in the imputation model.|Up to Week 52|ITT population.||percentage of participants|||Number
676828|NCT01617655|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 52 - ITT Analysis|Adjusted LS means and standard errors at Week 52 from MMRM model including all available post-baseline data from week 4 to week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|ITT population.||percent change||Standard Error|Least Squares Mean
676829|NCT01617655|Secondary|Percent Change From Baseline in Total-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|Total-C ITT population.||percent change||Standard Error|Least Squares Mean
676830|NCT01617655|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|Non-HDL-C ITT population.||percent change||Standard Error|Least Squares Mean
676831|NCT01617655|Secondary|Percent Change From Baseline in Apo B at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Apo B ITT population.||percent change||Standard Error|Least Squares Mean
676832|NCT01617655|Secondary|Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline total-C value on- or off-treatment (total-C ITT population).||percent change||Standard Error|Least Squares Mean
676833|NCT01617655|Secondary|Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|From Baseline to Week 52|Participants of the mITT population with one baseline and at least one post-baseline non-HDL-C value on-treatment (non-HDL-C mITT population).||percent change||Standard Error|Least Squares Mean
676834|NCT01617655|Secondary|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment (non-HDL-C ITT population).||percent change||Standard Error|Least Squares Mean
676835|NCT01617655|Secondary|Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|From Baseline to Week 52|Participants of the mITT population with one baseline and at least one post-baseline Apo B value on-treatment (Apo B mITT population).||percent change||Standard Error|Least Squares Mean
676929|NCT01615822|Secondary|OZ439 Cmax|Peak Plasma Concentration (Cmax) of OZ439|Up to 42 days post-dose|Only the subjects who completed all treatments in their respective cohort (per-protocol set) were included in the PK population.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
676836|NCT01617655|Secondary|Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline Apo B value on- or off-treatment (Apo B ITT population).||percent change||Standard Error|Least Squares Mean
676837|NCT01617655|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 i.e. up to 21 days after last injection.|From Baseline to Week 52|mITT population.||percent change||Standard Error|Least Squares Mean
676838|NCT01617655|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.||percent change||Standard Error|Least Squares Mean
676839|NCT01617655|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 i.e. up to 21 days after last injection (on-treatment analysis).|From Baseline to Week 52|Modified ITT (mITT) population: all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.||percent change||Standard Error|Least Squares Mean
676840|NCT01617655|Primary|Percent Change From Baseline in Calculated LDL-C at Week 24 - ITT Analysis|Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post­baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were used in the model (ITT analysis).|From Baseline to Week 52|ITT population: all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on- or off- treatment.||percent change||Standard Error|Least Squares Mean
676841|NCT01617603|Secondary|Oxidative Stress After 12 Weeks of Product Intake|Oxidative stress is assessed from measurements of plasma markers (High sensitivity CRP, IL-1, IL-6, and alpha-TNF) at the 84th day of product intake|84th day of product intake||||||
676842|NCT01617603|Secondary|Cholesterol Profile After 12 Weeks of Product Intake|Cholesterol profile is assessed from plasma HDL, LDL and total cholesterol measurements at the 84th day of product intake|84th day of product intake||||||
676843|NCT01617603|Secondary|Endothelial Function After 12 Weeks of Product Intake|Endothelial function is assessed from arterial stiffness measurements at the 84th day minus the value at baseline (1st day of product intake)|84th day of product intake||||||
676844|NCT01617603|Primary|Difference in Insulin Resistance (HOMA) Between Treatments After 12 Weeks of Product Intake|HbA1c with measurement of plasma glucose and insulin (to determine HOMA index) at the 84th day after product intake minus value at baseline (1st day of product intake. Insulin resistance is defined by a HOMA index > 2.4|84th day of product intake|||HOMA index||Inter-Quartile Range|Mean
676845|NCT01617577|Primary|Cognitive Measures Incluing ADAScog, Selected CANTABS Tests (Paired Associate Learning (PAL)and PAL )|"Scores from each of the cognitive assessments:
mean ADAScog: a decrease in total score units = improvement, min=0 max= mean PAL (memory): an increase in score = improvement, mean PAL (total trial adj): a decrease in score = improvement,"|Baseline and final visit (14 wks)|||units on a scale||Standard Error|Mean
676846|NCT01617577|Primary|Cognitive Measures Incluing ADAScog, Selected CANTABS Tests (Paired Associate Learning (PAL)and PAL )|"Scores from each of the cognitive assessments:
mean ADAScog: a decrease in total score units = improvement, min=0 max=31 mean PAL (memory): an increase in score = improvement, min= 0 max=12 mean PAL (total trial adj): a decrease in score = improvement,"|Baseline and 2wk and 4 wk after Rx;|||units on a scale||Standard Error|Mean
676847|NCT01617447|Primary|Mean Change From Baseline in the Aberrant Behavior Checklist Japanese Version (ABC-J) Irritability Subscale Score|The ABC-J Irritability subscale consists of 15 items. Each item scores range from 0 to 3: 0 = No problem, 1 = Mild aberrant behavior, 2 = Moderate aberrant behavior, and 3 = Severe aberrant behavior. Individual scores were summed, therefore, the overall score range was between 0-45. Higher scores represent worse condition.|baseline, 8 weeks after dosing|||units on a scale||Standard Error|Mean
676848|NCT01617434|Secondary|Number of Severe Hypoglycaemic Episodes During The Randomised Treatment Period|Severe hypoglycaemia episode was defined as an episode requiring assistance of another person to actively administer carbohydrate, glucagon or other resuscitative actions.|Week 0 to Week 26 + 7 days follow up|Safety analysis set includes all subjects who received at least one dose of the trial products.||Events/100 years of patient exposure|||Number
676849|NCT01617434|Secondary|Number of Minor Hypoglycaemic Episodes During The Randomised Treatment Period|A minor hypoglycaemic episode was defined as either, (a) an episode with symptoms consistent with hypoglycaemia with confirmation by blood glucose <2.8 mmol/L (50 mg/dL) or plasma glucose <3.1 mmol/L (56 mg/dL) that was handled by the subject him/herself or (b) any asymptomatic blood glucose value <2.8 mmol/L (50 mg/dL) or plasma glucose value <3.1 mmol/L (56 mg/dL).|Week 0 to Week 26 + 7 days follow up|Safety analysis set includes all subjects who received at least one dose of the trial products.||Events/100 years of patient exposure|||Number
676850|NCT01617434|Secondary|Number of Adverse Events (AEs) During The Randomised Treatment Period|An AE was defined as treatment emergent if the onset date (or increase in severity) was on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. The adverse events were categorised as 'serious' and 'non-serious' adverse events. Adverse events were also categorised according to the severity as 'mild', 'moderate' and 'severe' adverse events.|Week 0 to Week 26 + 7 days follow up|Safety analysis set includes all subjects who received at least one dose of the trial product.||Events/1000 years of patient exposure|||Number
676851|NCT01617434|Secondary|Number of Subjects Achieving HbA1c Below or Equal to 6.5% (American Association of Clinical Endocrinologists [AACE] Target)|Number of subjects achieving HbA1c below or equal to 6.5% (American Association of Clinical Endocrinologists [AACE] target) after 26 weeks of treatment.|At Week 26|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial product and who provided at least one post-baseline efficacy value. 211 subjects in the liraglutide arm and 217 subjects in the placebo arm contributed to the statistical analysis.||percentage of subjects|||Number
676852|NCT01617434|Secondary|Number of Subjects Achieving HbA1c Below 7.0% (American Diabetes Association [ADA] Target)|Number of subjects achieving HbA1c below 7.0% (American Diabetes Association [ADA] target) after 26 weeks of treatment|At Week 26|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial product (liraglutide or placebo) and who provided at least one post-baseline efficacy value. 211 subjects in the liraglutide arm and 217 subjects in the placebo arm contributed to the statistical analysis.||percentage of subjects|||Number
676853|NCT01617434|Secondary|Change in Body Weight From Baseline to Week 26|The estimated mean change in body weight after 26 weeks of treatment.|Week 0 to Week 26|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial product (liraglutide or placebo) and who provided at least one post-baseline efficacy value. 215 subjects in the liraglutide arm and 216 subjects in the placebo arm contributed to the statistical analysis.||kg||Standard Deviation|Mean
676854|NCT01617434|Secondary|Change in Mean Self-Measured Plasma Glucose (SMPG) of 7-Point Profile From Baseline to Week 26|The estimated mean change from baseline in mean SMPG of 7-point profile (7-points were before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner and at bedtime) after 26 weeks of treatment.|Week 0 to Week 26|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial product (liraglutide or placebo) and who provided at least one post-baseline efficacy value. 191 subjects in the liraglutide arm and 196 subjects in the placebo arm contributed to the statistical analysis.||mmol/L||Standard Deviation|Mean
676855|NCT01617434|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26|The estimated mean change from baseline in FPG after 26 weeks of treatment.|Week 0 to Week 26|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial product (liraglutide or placebo) and who provided at least one post-baseline efficacy value. 213 subjects in the liraglutide arm and 217 subjects in the placebo arm contributed to the statistical analysis.||mmol/L||Standard Deviation|Mean
676856|NCT01617434|Primary|Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 26|The estimated mean change from baseline in HbA1c after 26 weeks of treatment.|Week 0 to Week 26|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial product (liraglutide or placebo) and who provided at least one post-baseline efficacy value. 215 subjects in the liraglutide arm and 217 subjects in the placebo arm contributed to the statistical analysis.||percentage of glycosylated haemoglobin||Standard Deviation|Mean
676857|NCT01617369|Primary|Change in Whole Lung Mucociliary Clearance|"The primary outcome of mucociliary clearance (MCC) will be depicted by calculating the average rate of isotope clearance (%) from the whole lung compartment, measured for 90 minutes after isotope inhalation (MCC-Ave 90), using data points collected every 10 minutes.
Absolute change in MCC-Ave90 from baseline reported for each arm"|30 minutes and 4 hours after inhalation|Per Protocol||% Clearance||Standard Deviation|Mean
676858|NCT01617187|Secondary|Change From Baseline in PANSS Marder Factor Anxiety/Depression Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42|This measure reports results for the 4 items of the Marder anxiety/depression factor of the PANSS, which is a 30-item clinician-rated instrument used to assess schizophrenia symptoms. Marder factors are a modified grouping of the 30 PANSS items. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. PANSS Marder factor anxiety/depression symptom score for each participant was sum of rating assigned to each of the 4 applicable Marder factor items, and ranged from 4 to 28 with a higher score indicating greater severity of symptoms. Measure reports change from baseline; improvement in symptoms is represented by negative values.|Baseline and Days 4, 7, 14, 21, 28, 35 and 42|FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score||score on a scale||Standard Error|Least Squares Mean
676859|NCT01617187|Secondary|Change From Baseline in PANSS Marder Factor Hostility/Excitement Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42|This measure reports results for the 4 items of the Marder hostility/excitement factor of the PANSS, which is a 30-item clinician-rated instrument used to assess schizophrenia symptoms. Marder factors are a modified grouping of the 30 PANSS items. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. PANSS Marder factor hostility/excitement symptom score for each participant was sum of rating assigned to each of the 4 applicable Marder factor items, and ranged from 4 to 28 with a higher score indicating greater severity of symptoms. Measure reports change from baseline; improvement in symptoms is represented by negative values.|Baseline and Days 4, 7, 14, 21, 28, 35 and 42|FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score||score on a scale||Standard Error|Least Squares Mean
676860|NCT01617187|Secondary|Change From Baseline in PANSS Marder Factor Disorganized Thought Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42|This measure reports results for the 7 items of the Marder disorganized thoughts factor of the PANSS, which is a 30-item clinician-rated instrument used to assess schizophrenia symptoms. Marder factors are a modified grouping of the 30 PANSS items. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. PANSS Marder factor disorganized thought symptom score for each participant was sum of rating assigned to each of the 7 applicable Marder factor items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms. Measure reports change from baseline; improvement in symptoms is represented by negative values.|Baseline and Days 4, 7, 14, 21, 28, 35 and 42|FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score||score on a scale||Standard Error|Least Squares Mean
676861|NCT01617187|Secondary|Change From Baseline in PANSS Marder Factor Negative Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42|This measure reports results for the 7 items of the Marder negative symptoms factor of the PANSS, which is a 30-item clinician-rated instrument used to assess schizophrenia symptoms. Marder factors are a modified grouping of the 30 PANSS items. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. PANSS Marder factor negative symptom score for each participant was sum of the rating assigned to each of the 7 applicable Marder factor items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms. Measure reports change from baseline; improvement in symptoms is represented by negative values.|Baseline and Days 4, 7, 14, 21, 28, 35 and 42|FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score||score on a scale||Standard Error|Least Squares Mean
676862|NCT01617187|Secondary|Change From Baseline in PANSS Marder Factor Positive Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42|This measure reports results for the 8 items of the Marder positive symptom factor of the PANSS, which is a 30-item clinician-rated instrument used to assess schizophrenia symptoms. Marder factors are a modified grouping of the 30 PANSS items. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. PANSS Marder factor positive symptom score for each participant was sum of rating assigned to each of the 8 applicable Marder factor items, and ranged from 8 to 56 with a higher score indicating greater severity of symptoms. Measure reports change from baseline; improvement in symptoms is represented by negative values.|Baseline and Days 4, 7, 14, 21, 28, 35 and 42|FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score||score on a scale||Standard Error|Least Squares Mean
676863|NCT01617187|Secondary|Change From Baseline in PANSS General Psychopathology Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42|This measure reports results for the 16 items of the general psychopathology subscale of the PANSS, which is a 30-item clinician-rated instrument used to assess the symptoms of schizophrenia. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS general psychopathology subscale score for each participant was calculated as the sum of the rating assigned to each of the 16 subscale items, and ranged from 16 to 112 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline; improvement in symptoms is represented by negative values.|Baseline and Days 4, 7, 14, 21, 28, 35 and 42|FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score||score on a scale||Standard Error|Least Squares Mean
676864|NCT01617187|Secondary|Change From Baseline in PANSS Positive Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42|This measure reports results for the 7 items of the positive subscale of the PANSS, which is a 30-item clinician-rated instrument used to assess schizophrenia symptoms. Positive symptoms refer to an excess or distortion of normal mental status (e.g., delusions). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. PANSS positive subscale score for each participant was sum of the rating assigned to each of the 7 subscale items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms. Measure reports change from baseline; improvement in symptoms is represented by negative values.|Baseline and Days 4, 7, 14, 21, 28, 35 and 42|FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score||score on a scale||Standard Error|Least Squares Mean
676865|NCT01617187|Secondary|Change From Baseline in PANSS Negative Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42|This measure reports results for the 7 items of the negative subscale of the PANSS, which is a 30-item clinician-rated instrument used to assess schizophrenia symptoms. Negative symptoms represent a diminution or loss of normal functions (e.g., emotional withdrawal). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. PANSS negative subscale score for each participant was sum of the rating assigned to each of the 7 subscale items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms. Measure reports change from baseline; improvement in symptoms is represented by negative values.|Baseline and Days 4, 7, 14, 21, 28, 35 and 42|FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score||score on a scale||Standard Error|Least Squares Mean
676866|NCT01617187|Secondary|Percentage of Participants Who Are Clinical Global Impression Scale-Improvement (CGI-I) Responders at Days 4, 7, 14, 21, 28, 35 and 42|A CGI-I responder was defined as a participant who had a CGI-I score of 1 (very much improved) or 2 (much improved) at a post-baseline assessment. CGI-I is a 7-point scale for assessing the global improvement of the participant’s illness relative to baseline, with ratings from 1=very much improved to 7=very much worse. Missing data were imputed by LOCF.|Days 4, 7, 14, 21, 28, 35 and 42|FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score||percentage of participants|||Number
676867|NCT01617187|Secondary|Change From Baseline in CGI-S Score at Days 4, 7, 14, 21, 28 and 35|CGI-S is a 7-point scale for assessing the global severity of the participant’s illness, with ratings from 1=normal, not ill to 7=very severely ill. The reported measure is the change from baseline; improvement in symptoms is represented by negative values.|Baseline and Days 4, 7, 14, 21, 28 and 35|FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score||score on a scale||Standard Error|Least Squares Mean
676868|NCT01617187|Secondary|Percentage of Participants Who Are PANSS Responders (≥30% Reduction From Baseline in PANSS Total Score) at Days 4, 7, 14, 21, 28 and 35|A PANSS responder was defined as a participant who had a reduction from baseline of at least 30% in the PANSS total score at a post-baseline assessment. The PANSS is a 30-item clinician-rated instrument for assessing schizophrenia symptoms. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The Total score is the sum of the ratings for the individual items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. Missing data were imputed by LOCF.|Days 4, 7, 14, 21, 28 and 35|FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score||percentage of participants|||Number
676869|NCT01617187|Secondary|Change From Baseline in PANSS Total Score at Days 4, 7, 14, 21, 28 and 35|The PANSS is a 30-item clinician-rated instrument for assessing schizophrenia symptoms. It consists of 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score for each participant was sum of the rating assigned to each of the 30 PANSS items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline; improvement in symptoms is represented by negative values.|Baseline and Days 4, 7, 14, 21, 28 and 35|FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score||score on a scale||Standard Error|Least Squares Mean
676870|NCT01617187|Secondary|Change From Baseline in Body Weight at Day 42|Change from baseline in body weight at Day 42 is the Key Safety Outcome Measure.|Baseline and Day 42|All randomized participants who received ≥1 dose of study drug||kg||Standard Error|Least Squares Mean
681433|NCT01556906|Secondary|Absolute Change From Baseline in Hepatic Fat Percent|Absolute change from Baseline in hepatic fat percent|Baseline and 16 weeks of treatment|All patients treated||percent of hapatic fat||Standard Deviation|Mean
676871|NCT01617187|Secondary|Percentage of Participants Who Are PANSS Responders (≥30% Reduction From Baseline in PANSS Total Score) at Day 42|Rate of PANSS responders at Day 42 is a Key Secondary Outcome Measure. A PANSS responder was defined as a participant who had a reduction from baseline of at least 30% in the PANSS total score at a post-baseline assessment. The PANSS is a 30-item clinician-rated instrument for assessing schizophrenia symptoms. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The Total score is the sum of the ratings for the individual items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. Missing data were imputed by Last Observation Carried Forward (LOCF).|Baseline and Day 42|FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score||percentage of participants|||Number
676872|NCT01617187|Secondary|Change From Baseline in CGI-S Score at Day 42|Change from baseline in CGI-S score at Day 42 is a Key Secondary Outcome Measure. CGI-S is a 7-point scale for assessing the global severity of the participant’s illness, with ratings from 1=normal, not ill to 7=very severely ill. The reported measure is the change from baseline at Day 42; improvement in symptoms is represented by negative values.|Baseline and Day 42|FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score||score on a scale||Standard Error|Least Squares Mean
676873|NCT01617187|Primary|Change From Baseline in PANSS Total Score at Day 42|The PANSS is a 30-item clinician-rated instrument for assessing schizophrenia symptoms. It consists of 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score for each participant was sum of the rating assigned to each of the 30 PANSS items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Day 42; improvement in symptoms is represented by negative values.|Baseline and Day 42|FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score||score on a scale||Standard Error|Least Squares Mean
676874|NCT01617070|Primary|Urine Dopamine at the End of 4 Weeks|Evaluated for each subject under 4 conditions (washout, LNAA only, Kuvan only and LNAA+Kuvan)|measured every 4 weeks up to 16 weeks|Participates who completed all phases were measured.||ug/gCreatinine||Standard Deviation|Mean
676875|NCT01617070|Primary|Urine 6-sulfatoxymelatonin at the End of 4 Weeks|Evaluated for each subject under 4 conditions (washout, LNAA only, Kuvan only and LNAA+Kuvan)|measured every 4 weeks up to 16 weeks|Participates who completed all phases were measured.||ng/mg Creatinine||Standard Deviation|Mean
676876|NCT01617070|Primary|Serum Melatonin at the End of 4 Weeks|Evaluated for each subject under 4 conditions (washout, LNAA only, Kuvan only and LNAA+Kuvan)|measured every 4 weeks up to 16 weeks|Participates who completed all phases were measured.||pg/ml||Standard Deviation|Mean
676877|NCT01617005|Secondary|Time to Discontinuation Due to Lack of Efficacy||Baseline up to Week 24|As none of the participants discontinued treatment due to lack of efficacy, this outcome measure was not estimable.|||||
676878|NCT01617005|Secondary|Number of Participants Who Discontinued Treatment Due to Lack of Efficacy||Baseline up to Week 24|All participants enrolled in the study.||participants|||Number
676879|NCT01617005|Secondary|Number of Participants With Good or Moderate Response According to European League Against Rheumatism (EULAR) Criteria|EULAR response was based on 28-joint disease activity score (DAS28). The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline (CFB) in DAS28 score and the level of disease activity reached (absolute DAS28 score). Good responders had a CFB greater than (>) 1.2 with a DAS28 score less than or equal to (<=) 3.2; moderate responders had a CFB >1.2 with a DAS28 score >3.2 to <= 5.1 or a change from baseline >0.6 to <= 1.2 with a DAS28 score <= 5.1; non-responders had a CFB <=0.6 or CFB >0.6 to <=1.2 with DAS28 >5.1. Number of participants who achieved EULAR good response and EULAR moderate response were reported.|Baseline, Week 24|All participants enrolled in the study.||participants|||Number
676880|NCT01617005|Primary|Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs include both SAEs as well as non-serious AEs.|Baseline up to Week 24|All participants enrolled in the study.||participants|||Number
676881|NCT01616953|Secondary|Implant Stabilization|The ability of the dental implant fixtures to be loaded and remain stable for six months following implant loading (at 4 months) will be evaluated.|10 months|||participants|||Number
676882|NCT01616953|Primary|Bone Regeneration|The primary outcome variables for bone regeneration will be measured by histological and microcomputed tomographic (μCT) analyses at 4 months post-grafting.|4 months|||implant sites||Standard Deviation|Mean
676883|NCT01616771|Secondary|The Differences in the Glottis View (C&L Grade) of GVL Selected by Weight and Smaller Sized GVL|"Glottis view was scored using C&L grade by GVL selected by weight and smaller sized GVL, and compared each other.
Score range for the data reported in the table was between 1 and 6, with 1 representing best view and 6 representing no view."|up to 1day of surgery|Four of 23 patients could not be evaluated by smaller sized GVL because there was no smaller blade than their GVL selected by weight.||units on a scale||95% Confidence Interval|Median
676884|NCT01616771|Primary|The Differences in the Glottis View (C&L Grade) of Macintosh Laryngoscope and GVL Selected by Weight.|"Glottis view was scored using C&L grade by Macintosh laryngoscope and GVL selected by weight, and compared each other.
We used modified C&L grade: grade 1, all or most of the glottic aperture was visible; grade 2a, posterior cords and cartilage visible; grade 2b, only posterior cartilage visible; grade 3a, epiglottis visible and can be lifted; grade 3b, epiglottis adherent to the posterior pharynx; and grade 4, the epiglottis could not be visualized.
For the statistical analysis, the modified C&L grade was converted to an ordinal scale; grade 1 to 1, grade 2a to 2, grade 2b to 3, grade 3a to 4, grade 3b to 5, and grade 4 to 6. Therefore, score range for the data reported in the table was between 1 and 6, with 1 representing best view and 6 representing no view."|up to 1 day of surgery|||units on a scale||95% Confidence Interval|Median
676885|NCT01616576|Primary|Device-related Adverse Events|Device-related adverse events will be assessed to determine whether they impact current device safety performance.|2 weeks|||Events|||Number
676886|NCT01616576|Primary|Speech Perception With Control and Experimental Conditions Both Tested in Quiet, in Speech-spectrum Noise, and in Multi-talker Babble Noise.|Sentence recognition with the new (experimental) and current (control) sound processing strategies will be compared. Subjects will be tested using the AzBio corpus of sentences, which consists of 33 lists of 20 sentences each (6 to 10 words per sentence) that are equated for intelligibility. The difference between the Control percent correct scores and Experimental percent correct scores will be used for the analysis (Experimental AzBio scores minus Control AzBio scores). Data from both Group A and Group B were pooled for the analysis.|2 weeks|||Percent Correct||Standard Deviation|Mean
676887|NCT01616459|Secondary|Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 6C During the Booster Phase of the Study|No analysis was performed on opsonophagocytic activity for antibody titers against vaccine serotype 6C as no specific qualified/validated assay was available.|At study Month 11, e. g. at one month post-Booster vaccination with pneumococcal vaccine|The analysis was to be performed on the According-to-Protocol cohort for immunogenicity of the Booster Phase but no analysis was performed on opsonophagocytic activity for antibody titers against vaccine serotype 6C as no specific qualified/validated assay was available.|||||
676888|NCT01616459|Secondary|Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 6C During the Primary Phase of the Study|No analysis was performed on opsonophagocytic activity for antibody titers against vaccine serotype 6C as no specific qualified/validated assay was available.|At study Month 3, e. g. at one month post-Dose 3 of pneumococcal vaccine|The analysis was to be performed on the According-to-Protocol cohort for immunogenicity of the Primary Phase but no analysis was performed on opsonophagocytic activity for antibody titers against vaccine serotype 6C as no specific qualified/validated assay was available.|||||
676889|NCT01616459|Secondary|Antibody Concentrations Against Pneumococcal Serotype 6C During the Booster Phase of the Study.|No analysis was performed on Enzyme-Linked ImmunoSorbent Assay (ELISA) testing for antibody concentrations against vaccine serotype 6C as no specific qualified/validated assay was available.|At study Month 10 (M10) and Month 11 (M11), e.g.: prior to and at one month post booster vaccination with pneumococcal vaccine|The analysis was to be performed on the According-to-Protocol cohort for immunogenicity of the Booster Phase but no analysis was performed on Enzyme-Linked ImmunoSorbent Assay (ELISA) testing for antibody concentrations against vaccine serotype 6C as no specific qualified/validated assay was available.|||||
676890|NCT01616459|Secondary|Antibody Concentrations Against Pneumococcal Serotype 6C During the Primary Phase of the Study.|No analysis was performed on Enzyme-Linked ImmunoSorbent Assay (ELISA) testing for antibody concentrations against vaccine serotype 6C as no specific qualified/validated assay was available.|At study Month 3, e. g. at one month post-Dose 3 of pneumococcal vaccine|The analysis was to be performed on the According-to-Protocol cohort for immunogenicity of the Primary Phase. But no analysis was performed on Enzyme-Linked ImmunoSorbent Assay (ELISA) testing for antibody concentrations against vaccine serotype 6C as no specific qualified/validated assay was available|||||
676891|NCT01616459|Secondary|Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 19A During the Booster Phase of the Study|Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 19A (OPA-19A). The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. OPA-19A results were not available at the time of writing this summary. The summary will be updated when they become available.|At study Month 11, e. g. at one month post-Booster vaccination with pneumococcal vaccine||12/2017||||
676892|NCT01616459|Secondary|Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 19A During the Primary Phase of the Study|Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 19A (OPA-19A). The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8.. OPA-19A results were not available at the time of writing this summary. The summary will be updated when they become available.|At study Month 3, e. g. at one month post-Dose 3 of pneumococcal vaccine||12/2017||||
676893|NCT01616459|Secondary|Antibody Concentrations Against Pneumococcal Serotype 6A During the Booster Phase of the Study|Antibodies assessed for this outcome measure was that against the cross-reactive pneumococcal serotype 6A (ANTI-6A). Antibody concentrations were measured by 22F-Inhibition enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. Booster ELISA 6A results were not available at the time of writing this summary. The summary will be updated when they become available.|At study Month 10 (M10) and Month 11 (M11), e.g.: prior to and at one month post booster vaccination with pneumococcal vaccine||12/2017||||
676894|NCT01616459|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs) During the Entire Duration of the Study|A SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalisation, as per the medical or scientific judgement of the the physician. Any = Occurrence of a SAE, regardless of relationship to vaccination.|From Day 0 to Month 11|The analysis was performed on the Total Vaccinated cohort for the Booster Phase, which included all subjects who received the booster dose against pneumococcal diseases.||Subject|||Number
676895|NCT01616459|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs)During the Primary Phase of the Study|A SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalisation, as per the medical or scientific judgement of the physician. Any = Occurrence of a SAE, regardless of relationship to vaccination.|From Month 0 to Month 3|The analysis was performed on the Total Vaccinated cohort for the Primary Phase, which included all subjects who received at least one of the 3 vaccine doses priming against pneumococcal diseases.||Subject|||Number
676930|NCT01615822|Primary|OZ439 AUC0-t|Area under the plasma concentration versus time curve (AUC) of OZ439|Up to 42 days post-dose|Only the subjects who completed all treatments in their respective cohort (per-protocol set) were included in the PK population.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
676896|NCT01616459|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs) During the Booster Phase of the Study|An unsolicited AE was defined as any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination.|Within the 31-day (Days 0-30) period post booster vaccination|The analysis was performed on the Total Vaccinated cohort for the Booster Phase, which included all subjects who received the booster dose against pneumococcal diseases.||Subject|||Number
676897|NCT01616459|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs) During the Primary Phase of the Study|An unsolicited AE was defined as any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination.|Within the 31-day (Days 0-30) period post primary vaccination, across doses|The analysis was performed on the Total Vaccinated cohort for the Primary Phase, which included all subjects who received at least one of the 3 vaccine doses priming against pneumococcal diseases.||Subject|||Number
676898|NCT01616459|Secondary|Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Booster Phase of the Study|Assessed solicited general symptoms were Drowsiness, Irritability/Fussiness (Irr./Fuss.), Loss of appetite (Loss Appet.) and Fever (rectal temperature higher than [≥] 38.0 degrees Celsius [°C]). Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irr./Fuss. = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = Rectal temperature higher than (>) 40.0°C.|Within the 4-day (Days 0-3) period after booster vaccination|The analysis was performed on the Total Vaccinated cohort for the Booster Phase, which included all subjects who received the booster dose against pneumococcal diseases, with analysis done solely on subjects for whom post-vaccination results about solicited symptoms were available.||Subject|||Number
676899|NCT01616459|Secondary|Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study|Assessed solicited general symptoms were Drowsiness, Irritability/Fussiness (Irr./Fuss.), Loss of appetite (Loss Appet.) and Fever (rectal temperature higher than [≥] 38.0 degrees Celsius [°C]),. Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irr./Fuss. = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = Rectal temperature higher than (>) 40.0°C.|Within the 4-day (Days 0-3) post-vaccination period following each primary dose (D).|The analysis was performed on the Total Vaccinated cohort for the Primary Phase, which included all subjects who received at least one of the 3 vaccine doses priming against pneumococcal diseases, with analysis done solely on subjects for whom post-vaccination results about solicited symptoms were available.||Subjects|||Number
676900|NCT01616459|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Booster Phase of the Study|Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm).|Within the 4-day (Days 0-3) period after booster vaccination|The analysis was performed on the Total Vaccinated cohort for the Booster Phase, which included all subjects who received the booster dose against pneumococcal diseases, with analysis done solely on subjects for whom post-vaccination results about solicited symptoms were available.||Subjects|||Number
676901|NCT01616459|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase|Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm).|Within the 4-day (Days 0-3) post-vaccination period following each primary dose (D).|The analysis was performed on the Total Vaccinated cohort for the Primary Phase, which included all subjects who received at least one of the 3 vaccine doses priming against pneumococcal diseases, with analysis done solely on subjects for whom post-vaccination results about solicited symptoms were available.||Subjects|||Number
676902|NCT01616459|Secondary|Concentrations of Antibodies Against Protein D (Anti-PD) During the Booster Phase of the Study|Anti-PD antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The cut-off of the assay was an anti-PD antibody concentration higher than or equal to (≥) 100 EL.U/mL.|At study Month 10 (M10) and Month 11 (M11), e.g.: prior to and at one month post booster vaccination with pneumococcal vaccine|The analysis was performed on the ATP cohort for immunogenicity of the Booster Phase which included all evaluable subjects for whom data concerning booster immunogenicity outcome measures were available for antibodies against at least one vaccine antigen component before or after booster vaccination against pneumococcal diseases.||EL.U/mL||95% Confidence Interval|Geometric Mean
676931|NCT01615809|Secondary|Invasive Pulmonary Aspergillosis (IPA)-Related Mortality During Primary Prophylaxis With Abelcet® in Paediatric Patients With (AL) Undergoing Intensive Chemotherapy.|Percentage of deaths related to API during the prophylactic treatment period with Abelcet® in paediatric patients with (AL) undergoing intensive chemotherapy|at the Baseline visit (week 1) and at the end of the profilaxis treatment phase, up to 6 weeks|||percentage of deaths||95% Confidence Interval|Number
676903|NCT01616459|Secondary|Concentrations of Antibodies Against Protein D (Anti-PD) During the Primary Phase of the Study|Anti-PD antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The cut-off of the assay was an anti-PD antibody concentration higher than or equal to (≥) 100 EL.U/mL.|At study Month 3, e. g. at one month post-Dose 3 of pneumococcal vaccine|The analysis was performed on the According-to-Protocol cohort for immunogenicity of the Primary Phase which included all evaluable subjects for whom data concerning primary immunogenicity outcome measures were available for antibodies against at least one vaccine antigen component after primary vaccination against pneumococcal diseases.||EL.U/mL||95% Confidence Interval|Geometric Mean
676904|NCT01616459|Secondary|Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Booster Phase of the Study|Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19F and 23F (OPA-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19F and -23F). The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. Testing for opsonophagocytic activity against the cross-reactive pneumococcal serotype 6C will not be performed due to unavailability of a specific qualified assay.|At study Month 11, e.g.: at one month post booster vaccination with pneumococcal vaccine|The analysis was performed on the ATP cohort for immunogenicity of the Booster Phase which included all evaluable subjects for whom data concerning booster immunogenicity outcome measures were available for antibodies against at least one vaccine antigen component before or after booster vaccination against pneumococcal diseases.||Titers||95% Confidence Interval|Geometric Mean
676905|NCT01616459|Secondary|Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Primary Phase of the Study|Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19F and 23F (OPA-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19F and -23F). The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. Testing for opsonophagocytic activity against the cross-reactive pneumococcal serotype 6C will not be performed due to unavailability of a specific qualified assay.|At study Month 3, e. g. at one month post-Dose 3 of pneumococcal vaccine|The analysis was performed on the ATP cohort for immunogenicity of the Primary Phase which included all evaluable subjects for whom data concerning primary immunogenicity outcome measures were available for antibodies against at least one vaccine antigen component after primary vaccination against pneumococcal diseases.||Titers||95% Confidence Interval|Geometric Mean
676906|NCT01616459|Secondary|Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study|Antibodies assessed for this outcome measure were those against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -3, -4, -5, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F-Inhibition enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. Analysis of concentrations of antibodies against the cross-reactive pneumococcal serotype 6C (ANTI-6C) will not be performed due to unavailability of a specific qualified assay.|At study Month 10 (M10) and Month 11 (M11), e.g.: prior to and at one month post booster vaccination with pneumococcal vaccine|The analysis was performed on the ATP cohort for immunogenicity of the Booster Phase which included all evaluable subjects for whom data concerning booster immunogenicity outcome measures were available for antibodies against at least one vaccine antigen component before or after booster vaccination against pneumococcal diseases.||µg/mL||95% Confidence Interval|Geometric Mean
676907|NCT01616459|Primary|Percentage (%) of Subjects (Prevnar13 and 12Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Anti-6A and 19A Pneumococcal Serotypes|"N = number of subjects with post primary vaccination results available.
% = percentage of subjects with ELISA pneumococcal antibody concentrations ≥ 0.2 μg/mL.
Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotype 6A and 19A (ANTI-6A and 19A).
Antibody concentrations were measured by 22F-Inhibition enzyme-linked immunosorbent assay (ELISA)."|1 month post-dose 3 (primary phase)|The analysis was performed on the ATP cohort for immunogenicity of the Primary Phase which included all evaluable subjects for whom data concerning primary immunogenicity outcome measures were available for antibodies against at least one vaccine antigen component after primary vaccination against pneumococcal diseases.||Percentage of participants|||Number
676908|NCT01616459|Primary|Percentage (%) of Subjects (Synflorix and 12Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes|"N = number of subjects with post primary vaccination results available.
% = percentage of subjects with ELISA pneumococcal antibody concentrations ≥ 0.2 μg/mL.
Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F).
Antibody concentrations were measured by 22F-Inhibition enzyme-linked immunosorbent assay (ELISA)."|1 month post-dose 3 (primary phase)|The analysis was performed on the ATP cohort for immunogenicity of the Primary Phase which included all evaluable subjects for whom data concerning primary immunogenicity outcome measures were available for antibodies against at least one vaccine antigen component after primary vaccination against pneumococcal diseases.||Percentage of participants|||Number
676909|NCT01616459|Primary|Percentage (%) of Subjects (Prevnar13 and 11Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Anti-19A Pneumococcal Serotype|"N = number of subjects with post primary vaccination results available.
% = percentage of subjects with ELISA pneumococcal antibody concentrations ≥ 0.2 μg/mL.
Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotype 19A (ANTI-19A).
Antibody concentrations were measured by 22F-Inhibition enzyme-linked immunosorbent assay (ELISA)."|1 month post-dose 3 (primary phase)|The analysis was performed on the ATP cohort for immunogenicity of the Primary Phase which included all evaluable subjects for whom data concerning primary immunogenicity outcome measures were available for antibodies against at least one vaccine antigen component after primary vaccination against pneumococcal diseases.||Percentage of participants|||Number
677021|NCT01613599|Secondary|Incidence Rate of Adverse Events With Fatal Outcomes|Incidence rate is defined as events per 100 patient years.|From first dose until participant withdrawal or the date of latest participant visit (up to 37 months)|Safety population included all participants who received any dose of rituximab and whose safety data was verifiable.||events per 100 patient year|Total Patient-years at Risk|95% Confidence Interval|Number
676910|NCT01616459|Primary|Percentage (%) of Subjects (Synflorix and 11Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes|"N = number of subjects with post primary vaccination results available.
% = percentage of subjects with ELISA pneumococcal antibody concentrations ≥ 0.2 μg/mL.
Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F).
Antibody concentrations were measured by 22F-Inhibition enzyme-linked immunosorbent assay (ELISA)."|1 month post-dose 3 (primary phase)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity of the Primary Phase which included all evaluable subjects for whom data concerning primary immunogenicity outcome measures were available for antibodies against at least one vaccine antigen component after primary vaccination against pneumococcal diseases.||Percentage of participants|||Number
676911|NCT01616459|Primary|Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study|Antibodies assessed for this outcome measure were those against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F-Inhibition enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. Primary outcome results correspond to antibody concentrations for all serotypes presented at the exception of those for the antibodies against the cross-reactive pneumococcal serotype 3 (ANTI-3).|At study Month 3, e. g. at one month post-Dose 3 of pneumococcal vaccine|The analysis was performed on the According-to-Protocol cohort for immunogenicity of the Primary Phase which included all evaluable subjects for whom data concerning primary immunogenicity outcome measures were available for antibodies against at least one vaccine antigen component after primary vaccination against pneumococcal diseases.||µg/mL||95% Confidence Interval|Geometric Mean
676912|NCT01616173|Secondary|Pain Scores|Patients were asked to rate their pain score during activity on a 11-point scale (0 = no pain to 10 = excruciating pain).|2 weeks|||units on a scale||Inter-Quartile Range|Median
676913|NCT01616173|Secondary|Opioid Consumption|Postoperative opioid consumption was converted to equivalent dose of oral morphine at two weeks following surgery.|2 weeks|||mg/day||Inter-Quartile Range|Median
676914|NCT01616173|Primary|Quality of Recovery|QoR-40 questionnaire instrument consists of 40 questions that examine 5 domains of patient recovery using a 5 point Likert scale: none of the time, some of the time, usually, most of the time and all of the time. The five domains include physical comfort, pain, physical independence, psychological support and emotional state. Global QoR-40 scores range from minimum of 40 to a maximum of 200. The scores are added together to compute a total score. A low score of 40 represents very poor quality of recovery while a high score, i.e. 200 represents outstanding quality of recovery.|2 weeks|||units on a scale||Inter-Quartile Range|Median
676915|NCT01616056|Secondary|Change in Optical Coherence Tomography|Patients were assessed by ophthalmologists at enrollment, 2 weeks and afterwards as medical needed.|2 weeks|Optical coherence tomography results were not analyzed because of incomplete data collection.|||||
676916|NCT01616056|Secondary|Change in Comprehensive Ophthalmologic Evaluations|LogMAR visual acuity score of 0 is equivalent to 20/20 vision. Patients were assessed by ophthalmologists at enrollment, 2 weeks and afterwards as medical needed.|2 weeks|Ophthalmology assessments made after 2 weeks were not analyzed because of incomplete data collection.||logMAR||Standard Deviation|Mean
676917|NCT01616056|Secondary|Number of Patients Who Experienced Serious Adverse Events|Safety of Bandage Contact Lenses at 1 month|1 month|||Participants|||Count of Participants
676918|NCT01616056|Primary|Number of Participants Who Perceived a Clinically Meaningful Change as Measured by the 11-point Eye Scale|The 11-point eye scale goes from 0 not present to 10 as bad as you can imagine. Clinically meaningful change is defined as a 2 point or more decrease.|3 months|||Participants|||Count of Participants
676919|NCT01616056|Primary|Change in Patient-reported Symptoms as Measured by the 11-point Eye Rating Scale|The 11-point eye scale goes from 0 not present to 10 as bad as you can imagine. Clinically meaningful change is defined as a 2 point or more decrease.|3 months|||units on a scale||Standard Deviation|Mean
676920|NCT01616056|Primary|Number of Participants Who Perceived a Clinically Meaningful Change as Measured by the OSDI|OSDI minimum score: 0, correlated with better outcome, maximum score: 100, correlated with worse outcome. 12 questions 0 none of the time to 4 all of the time. (Sum of scores)x25/number of questions answered. Clinically meaningful change scores are half a standard deviation, which is 10.9 for the OSDI.|3 months|||Participants|||Count of Participants
676921|NCT01616056|Primary|Change in Patient-reported Symptoms as Measured by the Ocular Surface Disease Index|OSDI minimum score: 0, correlated with better outcome, maximum score: 100, correlated with worse outcome. 12 questions 0 none of the time to 4 all of the time. (Sum of scores)x25/number of questions answered. Clinically meaningful change scores are half a standard deviation, which is 10.9 for the OSDI.|3 months|||units on a scale||Standard Deviation|Mean
676922|NCT01616056|Primary|Number of Participants Who Perceived a Clinically Meaningful Change as Measured by the 8-level Lee Eye Symptom Subscale|8-level change score is from 0 completely gone to 7 very much worse. Clinically meaningful improvement is defined as half a standard deviation (decreased score of 11.8 or greater).|3 months|||Participants|||Count of Participants
676923|NCT01616056|Primary|Change in Patient-reported Symptoms Measured by the 8-point Lee Eye Subscale|Lee eye subscale: sx6 dry eyes, sx7 need to use eye drops frequently, sx8 difficulty seeing clearly 0=not at all, 4=extremely bothered. If have at least one of (sx6,sx7,sx8), then sx_eye=mean(sx6,sx7,sx8)*25. Minimum possible score: 0 correlated with better outcome, maximum score possible: 100 correlated with worse outcome. Clinically meaningful change is half a standard deviation, which is a decrease of 11.8 of more for this scale.|3 months|||units on a scale||Standard Deviation|Mean
676924|NCT01615939|Secondary|Pain Control|Numeric rating score for pain (NRS) 0 to 10 scale where 0 equals no pain and 10 equals the worst pain imaginable|72 hrs|||units on a scale||Inter-Quartile Range|Median
676925|NCT01615939|Secondary|Participant Satisfaction With Anesthesia|Patient satisfaction on a 0 to 10 scale with 0 equals completely dissatisfied and 10 equals completely satisfied|24 hours|||units on a scale||Inter-Quartile Range|Median
676926|NCT01615939|Primary|Temporary Neurologic Symptoms Between Groups|Temporary neurologic symptoms between groups; muscle weakness of either foot dorsiflexion and plantar flexion|1 month|||percentage of total participants|||Number
676932|NCT01615809|Secondary|Efficacy of Primary Prophylaxis With Nebulized Abelcet® on the Incidence of Invasive Pulmonary Aspergillosis (IPA) in Paediatric Patients With Acute Leukaemia (AL) Undergoing Intensive Chemotherapy|The Incidence of IPA during the Abelcet® prophylactic treatment period was assessed by the relation between the number of patients with IPA and the number of patients on prophylaxis.|at the Baseline visit (week 1) and at the end of the profilaxis treatment phase, up to 6 weeks|At baseline, none of the 32 pediatric patients with acute leukemia included in the clinical trial had API. During the trial period there were 3 patients who developed API||participants|||Number
676933|NCT01615809|Primary|Number of Participants With Adverse Events That Results in the Interruption of Treatment, as a Measure of Safety and Tolerability|is assessed by the proportion of patients who discontinue prophylactic treatment with Abelcet® due to an adverse event that is related or not to the study drug or for intolerability to it. The last week of treatment will have a different calendar for each participant, depending on the number of cicles needed by each patient (it has been anticipated up to 5 cicles of 2-6 weeks each).|at the Baseline visit (week 1) and during the Last week of treatment, up to 6 weeks|pediatric patients||participants|||Number
676942|NCT01615328|Secondary|VAS of Neck Pain(Postoperative 6 Months)|"Evaluation of neck pain using the visual analogue scale (VAS) at 6 months after operation (ACDF).
Reported pain using VAS was recorded and evaluated. Patients were instructed to make a mark on a horizontally-oriented, 10-point VAS labeled “no pain (zero point)” at the far left and “greatest pain (ten point)” at the far right."|at 6 months after surgery (ACDF)|||scores on a scale||Standard Deviation|Mean
676943|NCT01615328|Secondary|VAS of Radiating Pain (Postoperative 6 Months)|"Evaluation of radiating pain using the visual analogue scale (VAS) at 6 months after operation (ACDF).
Reported pain using VAS was recorded and evaluated. Patients were instructed to make a mark on a horizontally-oriented, 10-point VAS labeled “no pain (zero point)” at the far left and “greatest pain (ten point)” at the far right."|at 6 months after surgery (ACDF)|||scores on a scale||Standard Deviation|Mean
676944|NCT01615328|Primary|Bone Fusion With CT(Postoperative 6 Months)|Evaluation of bone fusion between bone substitutes and cervical vertebral endplates with 3-dimensional CT at 6 months after operation (ACDF).|6 months after surgery(ACDF)|||participants|||Number
676945|NCT01615263|Secondary|Use of Suction to Facilitate Lung Collapse||Up to 5 minutes after surgery|||participants|||Number
676946|NCT01615263|Secondary|Opinion on the Device|20 minutes after pleural opening, the thoracic surgeon will give his opinion on the lung isolation device that was used on his patient (double lumen tube or bronchial blocker).|20 minutes after pleural opening|||percentage of right guess/opinion|||Number
676947|NCT01615263|Secondary|Quality of Lung Collapse|"Assessment of lung collapse by the thoracic surgeon at 0, 5, 10 and 20 minutes after pleural opening.Visual analog scale of the quality of lung collapse will be assessed as the following:
No lung collapse
Partial lung collapse, not satisfactory
Partial lung collapse, satisfactory
Complete lung collapse"|From pleural opening to 20 minutes after|||percentage of patients|||Number
676948|NCT01615263|Primary|Time to Obtain Complete Lung Collapse|For patients intubated with double lumen tube (DLT), clamping of the ipsilateral lumen without continuous positive airway pressure (CPAP) on the isolated lung will be done to allow lung collapse. The timer will be started at this moment and stopped 20 minutes after pleural opening. For patients of the bronchial blocker (BB) group, the first apnea period will of 30 seconds, keeping a pulse oximetry (SpO2) always over 97%, and under direct visualization with the FOB. Afterward, the cuff will be reflated and the timer will be started at this moment and stopped 20 minutes after pleural opening. For both groups, time of total lung collapse will be measured.|From the beginning of one lung ventilation to 20 minutes after pleural opening|||minutes||Standard Deviation|Mean
676949|NCT01615198|Secondary|Number of Participants With Adverse Events, Serious Adverse Events and Death|Adverse event monitoring was conducted throughout the study.|14 weeks|Participants from the safety analysis set were analyzed. The safety analysis set included all randomized participants who received study medication and had post baseline assessments.||Participants|||Number
677078|NCT01613248|Secondary|Percentage of Participants Reporting Absence of Phonophobia at 2 Hours Post-Dose|Phonophobia is sensitivity to loud sounds.|2 hours post-dose|Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis.||percentage of participants||95% Confidence Interval|Number
676950|NCT01615198|Secondary|Number of Participants Achieving Successful Response in msSBP and msDBP|Blood pressure response in msSBP was defined as a mean sitting BP < 140 mmHg or a >=20 mmHg reduction from baseline. Blood pressure response in msDBP was defined as a mean sitting diastolic blood pressure, 90 mmHg or >=10 mmHg reduction from baseline.|4 weeks,10 weeks, 14 weeks|Participants from the full analysis set (FAS), who had both baseline and post baseline values at each given time point, were included in the analysis. The FAS included all participants who received study medication and had post baseline BP assessments.||Participants|||Number
676951|NCT01615198|Secondary|Number of Participants Achieving Overall Blood Pressure Control in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)|A successful response in overall BP control rate was defined as msSBP < 140 mmHg and msDBP <90 mmHg.|4 weeks, 10 weeks, 14 weeks|Participants from the full analysis set (FAS), who had both baseline and post baseline values at each given time point, were included in the analysis. The FAS included all participants who received study medication and had post baseline BP assessments.||Participants|||Number
676952|NCT01615198|Secondary|Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers|ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. Readings were taken every 20 minutes over the 24 hour period in the non-dominant arm. A non-dipper was defined as a participant who, at baseline, had a mean nighttime ABPM (10 pm - 6 am) that did not drop ≥ 10% below his or her mean daytime ABPM (6 am - 10 pm). A negative change from baseline indicates improvement.|Baseline, 10 weeks|A subset of ABPM participants were considered for the analysis. For each post-dosing hour, only participants with values at baseline and the post dosing hour end point were included in the analysis for that end point.||mmHg||Standard Deviation|Mean
676953|NCT01615198|Secondary|Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers|ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. Readings were taken every 20 minutes over the 24 hour period in the non-dominant arm. A non-dipper was defined as a participant who, at baseline, had a mean nighttime ABPM (10 pm - 6 am) that did not drop ≥ 10% below his or her mean daytime ABPM (6 am - 10 pm). A negative change from baseline indicates improvement.|Baseline, 10 weeks|A subset of ABPM participants were considered for the analysis. For each post-dosing hour, only participants with values at baseline and the post dosing hour end point were included in the analysis for that end point.||mmHg||Standard Deviation|Mean
676954|NCT01615198|Secondary|Change From Baseline in Daytime and Nighttime maSBP/maDBP|ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. Readings were taken every 20 minutes over the 24 hour period in the non-dominant arm. A negative change from baseline indicates improvement.|Baseline, 10 weeks|A subset of participants, who participated in ambulatory blood pressure monitoring, was analyzed.||mmHg||Standard Error|Least Squares Mean
676955|NCT01615198|Secondary|Change From Baseline in Mean Sitting Pulse Pressure|Pulse rate was with automated BP device after the 4th blood pressure measurement at each visit.|Baseline, 4 weeks, 10 weeks, 14 weeks|Participants from the full analysis set (FAS), who had both baseline and post baseline values at the given time point, were included in the analysis. The FAS included all participants who received study medication and had post baseline BP assessments.||mmHg||Standard Error|Least Squares Mean
676956|NCT01615198|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)|Sitting BP measurements was performed at trough (immediately prior to dosing at the clinic). At study entry, BP was measured in both arms. The arm with the higher SBP reading was used for the 4 measurements at screening visit and the same arm was used at all subsequent visits. A negative change from baseline indicates improvement.|Baseline, 10 weeks|Participants from the full analysis set (FAS), who had both baseline and week 10 values, were included in the analysis. The FAS included all participants who received study medication and had post baseline BP assessments.||mmHg||Standard Error|Least Squares Mean
676957|NCT01615198|Secondary|Change in Baseline in Mean 24 Hour Ambulatory Diastolic Blood Pressure (maDBP)|ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. Readings were taken every 20 minutes over the 24 hour period in the non-dominant arm. A negative change from baseline indicates improvement.|Baseline, 10 weeks|A subset of participants, who participated in ambulatory blood pressure monitoring, was analyzed.||mmHg||Standard Error|Least Squares Mean
676958|NCT01615198|Secondary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)|Sitting BP measurements were performed at trough (immediately prior to dosing at the clinic). At study entry, BP was measured in both arms. The arm with the higher SBP reading was used for the 4 measurements at screening visit and the same arm was used at all subsequent visits. A negative change from baseline indicated improvement.|Baseline, 4 weeks, 14 weeks|Participants from the full analysis set (FAS), who had both baseline and post baseline values at each given time point, were included in the analysis. The FAS included all participants who received study medication and had post baseline BP assessments.||mmHg||Standard Error|Least Squares Mean
676959|NCT01615198|Secondary|Change From Baseline in Mean 24 Hour Ambulatory Systolic Blood Pressure (maSBP)|ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. Readings were taken every 20 minutes over the 24 hour period in the non-dominant arm. A negative change from baseline indicates improvement.|Baseline, 10 weeks|A subset of participants, who participated in ambulatory blood pressure monitoring, was analyzed.||mmHg||Standard Error|Least Squares Mean
676960|NCT01615198|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)|Sitting BP measurements were performed at trough (immediately prior to dosing at the clinic). At study entry, BP was measured in both arms. The arm with the higher SBP reading was used for the 4 measurements at screening visit and the same arm was used at all subsequent visits. A negative change from baseline indicates improvement.|Baseline, 10 weeks|Only participants, who had both baseline and week 10 values, were included in the analysis. The FAS included all randomized participants who received study medication and had post baseline BP assessments.||mmHg||Standard Error|Least Squares Mean
676961|NCT01615029|Secondary|Phase 2: Overall Survival (OS)|Overall Survival (OS) was defined as the number of days from administration of the first infusion (Day 1) to date of death. Median Overall Survival was estimated by using the Kaplan Meier method.|Up to 3 years|ITT population analysis set included all enrolled participants who signed the informed consent during Phase 2.||Months||95% Confidence Interval|Median
676962|NCT01615029|Secondary|Phase 2: Time to Response|Time to first response was defined as the time from the date of first dose of daratumumab to the date of initial documentation of a response (PR or better). Time to best response was defined as the time between the date of first dose of daratumumab and the date of the initial evaluation of the best response (PR or better) to treatment.|Up to 3 years|ITT population analysis set included all enrolled participants who signed the informed consent during Phase 2.||Months||Standard Deviation|Mean
676963|NCT01615029|Secondary|Phase 1: Time to Response|Time to first response was defined as the time from the date of first dose of daratumumab to the date of initial documentation of a response (PR or better). Time to best response was defined as the time between the date of first dose of daratumumab and the date of the initial evaluation of the best response (PR or better) to treatment.|Up to 3 years|Responders in all treated population analysis set included.||Months||Standard Deviation|Mean
676964|NCT01615029|Secondary|Phase 2: Progression-Free Survival (PFS)|Progression free survival (PFS) was defined as the time between the date of first dose of daratumumab and either disease progression or death, whichever occurs first.|Up to 3 years|ITT population analysis set included all enrolled participants who signed the informed consent during Phase 2.||Months||95% Confidence Interval|Median
676965|NCT01615029|Secondary|Phase 2: Duration of Response|Duration of response was calculated from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the International Myeloma Working Group (IMWG) criteria.|Up to 3 years|Responders in Intent-to-Treat (ITT) population analysis set included.||Months||95% Confidence Interval|Median
676966|NCT01615029|Secondary|Phase 2: Time to Progression (TTP)|TTP was defined as the number of days from the date of first infusion (Day 1) to the date of first record of disease progression. Disease progression (IMWG criteria): increase of >=25 percent (%) from lowest response level in Serum M-component and/or (the absolute increase must be >=0.5 g/dL) Urine M-component and/or (the absolute increase must be >=200 mg/24 hour; only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain levels. The absolute increase must be >10 mg/dL; Bone marrow plasma cell percentage: the absolute % must be >=10 %; Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder. Median TTP was estimated by using the Kaplan-Meier method.|Up to 3 years|ITT population analysis set included all enrolled participants who signed the informed consent during Phase 2.||Months||95% Confidence Interval|Median
676967|NCT01615029|Primary|Phase 2: Percentage of Participants With Overall Response Rate (ORR)|ORR is defined as percentage of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR). IMWG criteria- CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and less than (<) 5 percentage (%) plasma cells in bone marrow; sCR: CR+Normal free light chain ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; PR: greater than eqaul to (>=) 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >= 90 percentage (%) or to <200 mg/24 hours; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100 mg per 24 hour.|Up to 3 years|Intent-to-Treat (ITT) population analysis set included all enrolled participants who signed the informed consent during Phase 2.||Percentage of participants||95% Confidence Interval|Number
676968|NCT01615029|Primary|Phase 1: Percentage of Participants With Overall Response Rate (ORR)|ORR is defined as percentage of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR). International Myeloma Working Group (IMWG) criteria- CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and less than (<) 5 percentage (%) plasma cells in bone marrow; sCR: CR+Normal free light chain ratio and absence of clonal cells in bone marrow by immunohistochemistry or immuno fluorescence; PR: greater than equal to (>=) 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >= 90 percentage (%) or to <200 mg/24 hours; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100 mg per 24 hour.|Up to 3 years|All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1.||Percentage of participants||95% Confidence Interval|Number
676969|NCT01614886|Secondary|The Percentage of Treatment Retention.|Treatment retention rate at effective dose is defined as the proportion of patients who met all the followings – 1) completed the study, 2) received rivastigmine patch 18 mg/day throughout the last 8 weeks 3) received 18 mg/day for ≥75% of the days during the last 8 weeks|Up to 24 weeks|Safety population (SAF) This population consisted of all randomized patients who received at least one dose of study medication and had at least one safety assessment after baseline. Patients were analyzed according to the treatment group they were assigned to at randomization.||Percentage of Participants|||Number
676970|NCT01614886|Secondary|Number of Participants With Improvement in Japanese Clinical Global Impression of Change (J-CGIC). Patients With “Improvement”: a Total of 1. Markedly Improved, 2. Improved, and 3. Slightly|The J-CGIC is simple 7 grade investigator’s impression scale (1. Markedly improved, 2. Improved, 3. Slightly improved, 4. No change, 5. Slightly aggravated, 6. Aggravated, 7. Markedly aggravated) and a patient is defined to have improvement if J-CGIC tool the values 1, 2, or 3.|4, 8, 12,16, 20 and 24 weeks|Full analysis set (FAS): The FAS includes all randomized patients who received at least one dose of study drug and had at least one pre- and post-baseline assessment for any of the efficacy variables. n is the number of patients with an assessment at baseline and the corresponding visit.||Participants|||Number
676971|NCT01614886|Secondary|Change From Baseline in Mini-Mental State Examination (MMSE)|The MMSE was used to measure severity of Alzheimer’s disease. The test consists of 2 parts: language (time orientation, registration and attention) and performance (recall, response to written/verbal commands, sriting ability and reproduction of complex polygons); the total score can range from 0 to 30, with a higher score indicating better function. A positive change score indicates improvement from baseline.|Baseline and 24 weeks|Full analysis set (FAS): The FAS includes all randomized patients who received at least one dose of study drug and had at least one pre- and post-baseline assessment for any of the efficacy variables. n is the number of patients with an assessment at baseline and the corresponding visit.||Units on a scale||Standard Deviation|Mean
676972|NCT01614886|Secondary|Change From Baseline in the Alzheimer's Disease Assessment Scale - Japan Cognitive Subscale (ADAS-J Cog)|The Alzheimer's Disease Assessment Scale - Japan cognitive subscale (ADAS-J cog) was used to measure change in cognitive function. The ADAS-J cog score ranges from 0-70, with higher total scores indicating more impairment. A negative change score indicates improvement from baseline.|Baseline, 8,16, and 24 weeks|Full analysis set (FAS): includes all randomized patients who received at least one dose of study drug and had at least one pre- and post-baseline assessment for any of the efficacy variables. n is the number of patients with an assessment at baseline and the corresponding visit.||Units on a scale||Standard Deviation|Mean
676973|NCT01614886|Primary|Percentage of Patients With Adverse Events Leading to Study Drug Discontinuation|The primary variable of this study is the percentage of patients having an AE leading to study drug discontinuation during the 24-week double-blind treatment period.|Up to 24 weeks|Safety population (SAF) This population consisted of all randomized patients who received at least one dose of study medication and had at least one safety assessment after baseline.||Percentage of participants|||Number
676974|NCT01614795|Secondary|Observed Incidence in Each Reporting Period by Type and Grade of Toxicity as Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0||25 cycles (700 days)||||||
676975|NCT01614795|Secondary|Percentage of Patients With Detectable Bone Marrow Micrometastatic Disease Estimated as the Proportion of Eligible Patients Entered Into the Ewing Sarcoma Stratum Who Have Detectable Tumor Cells in the Marrow at Enrollment||Baseline||||||
676976|NCT01614795|Secondary|Percentage of Patients Expressing IGF-1R, Insulin Receptor, ERK, RON, and mTOR||Up to 5 years||||||
676977|NCT01614795|Secondary|Progression-free Survival|Will be calculated according to the method of Gray accounting for censoring and the competing events.|The date of enrollment until the end PFI date, calculated as the date of disease progression, date of death, date of removal of all tumor by surgery or last patient contact, whichever occurs first, assessed up to 5 years||||||
676978|NCT01614795|Primary|Objective Response Rate (PR or CR) by Response Evaluation Criteria in Solid Tumors (RECIST).|We will consider the combination of sufficient activity if the true response rate is 35% or greater. .|6 cycles (168 days)|One (1) of the patients in Group 1 and one (1) of the patients in Group 4 were considered inevaluable for response assessment. One (1) of the patients in Group 2 was ineligible.||participants|||Number
676979|NCT01614769|Primary|Incremental Weighted Average Blood Glucose Concentration Over 3 Hours of Hypoglycemic Recovery|The incremental weighted average qualitatively assesses overall hypoglycemic recovery by measuring mean glycemia over the 3 hour recovery period. Blood glucose measured at the release of the hypoglycemic clamp, considered the baseline value, was subtracted from blood glucose values measured over the ensuing 3 hours of hypoglycemic recovery. These differences from baseline were averaged to calculate the incremental weighted average blood glucose concentration.|From 1 to 180 minutes post hypoglycemic clamp|The per-protocol population consisting of participants who received drug and completed the necessary post treatment measurements for at least one treatment period.||mg/dL||90% Confidence Interval|Least Squares Mean
676980|NCT01614769|Primary|Rate of Recovery From Hypoglycemia to Euglycemia|The rate of recovery is the difference in concentration between blood glucose at euglycemia and at the end of the hypoglycemic clamp, divided by the recovery time.|From 1 to 180 minutes post hypoglycemic clamp|The per-protocol population consisting of participants who received drug and completed the necessary post treatment measurements for at least one treatment period.||mg/dL/minute||90% Confidence Interval|Least Squares Mean
676981|NCT01614769|Primary|Recovery Time From Hypoglycemia to Euglycemia|Immediately after release of the hypoglycemic clamp, which maintained blood glucose close to 50 mg/dL, the time taken until glucose reached euglycemia, defined as 3 consecutive measurements >= 70 mg/dL, is called the recovery time.|From 1 to 180 minutes post hypoglycemic clamp|The per-protocol population consisting of participants who received drug and completed the necessary post treatment measurements for at least one treatment period.||Minutes||90% Confidence Interval|Least Squares Mean
676982|NCT01614613|Secondary|Number of Subject Responses 'Strongly Agree' 'Agree' or 'Neutral' With Questionnaire Statements|Subjects responded to statements about meter accuracy and diabetes management. Subject responses: 'Strongly Agree' 'Agree' 'Neutral' 'Disagree' or 'Strongly Disagree'or No Response. □1ACCURACY HELPS 1A-with my ability to talk with my HCP. 1B-my satisfaction with my self monitoring of diabetes. 1C-with my ability to manage my diabetes. 1D-prevent low BG. 1E-understand how food/exercise affects low BG. □2 I WOULD USE ONLY the meter and strips my insurance company pays for, even if a more accurate meter was available. □3 I USE MY CURRENT METER BECAUSE 3A-my HCP gave it to me. 3B-my insurance company covers the strips. 3C-I think it is the most accurate meter. □4 I WOULD SWITCH meters for a more accurate meter. □5BEING ABLE TO APPLY MORE BLOOD IS IMPORTANT 5A-as I have wasted test strips by not having enough blood to fill the strip 5B-as this would save test strips 5C-I would switch to a meter with this feature|1 hour|Since subjects had the option to provide No Response at all to a question, some questionnaire statements had less than 146 participant responses possible (see numbers in parentheses)||participants|||Number
676983|NCT01614613|Secondary|Standard Deviations of BGMS Differences (Between BGM Meter Readings and the YSI Laboratory Reference Values Across the BG Range of All Evaluable Samples 21 mg/dL to 496 mg/dL)|Variability of each meter system was determined by calculating the Standard Deviation derived from each meter's differences between Blood Glucose Meter (BGMS)results and corresponding YSI Blood Glucose (BG) results.|6 hours|Same numbers (538) of BG results were possible for each BGMS. A capillary sample was collected from each subject at 3 different times during the visit to obtain natural capillary blood samples with a range of glucose concentrations. Subjects provided 438 unmodified capillary samples and 100 samples were modified (21 to 496 mg/dL).||Standard Deviation|Participants||Number
677002|NCT01614470|Secondary|Part 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: any adverse change from subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording/clinical laboratory assessment which occurs during course of study, whether it is considered related to study drug or not. SAE: medical event or condition, which falls into any of following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolonged hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect, important medical event.|Part 1: From signing of informed consent up to Week 20|Safety Set for Part 1 included all subjects who received at least 1 dose of study drug (ivacaftor or placebo).||participants|||Number
676984|NCT01614613|Secondary|MAD Mean Absolute Value of the Difference Between Blood Glucose Meter (BGMS) Results and Corresponding YSI Blood Glucose (BG) Results in the BG Range >180 mg/dL|"Using samples with BG >180 mg/dL, the Mean Absolute Value of the Differences Between BGM system readings and the YSI laboratory reference values was compared. MAD was calculated from the sum of all |(BG meter)-(BG reference)| assessments, divided by the number of assessments. Each evaluable sample was tested on all 6 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MAD value indicates smaller difference between meter value and the reference value. Higher MAD value indicates larger difference between meter value and the reference value."|6 hours|Same number (231) of BG results was possible for each BGMS. A capillary sample was collected from each subject at 3 different times during the visit to obtain natural capillary blood samples with a range of glucose concentrations. Subjects provided 181 unmodified capillary samples >180 mg/dL and 50 samples were modified by adding glucose solution.||mg/dL|Participants|Standard Error|Least Squares Mean
676985|NCT01614613|Secondary|MAD Mean Absolute Value of the Difference Between Blood Glucose Meter (BGMS) Results and Corresponding YSI Blood Glucose (BG) Results in the BG Range 70 to 180 mg/dL|"Using samples with BG 70 mg/dL to 180 mg/dL, the Mean Absolute Value of the Differences Between BGM system readings and the YSI laboratory reference values were compared. MAD was calculated from the sum of all|(BG meter)-(BG reference)| assessments, divided by the number of assessments. Each evaluable sample was tested on all 6 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MAD value indicates smaller difference between meter value and the reference value. Higher MAD value indicates larger difference between meter value and the reference value."|6 hours|Same number (172) of BG results was possible for each BGMS. A capillary sample was collected from each subject at 3 different times during the visit to obtain natural capillary blood samples with a range of glucose concentrations. Subjects provided all 172 capillary samples (70 to 180 mg/dL) and no samples were modified.||mg/dL|Participants|Standard Error|Least Squares Mean
676986|NCT01614613|Primary|MAD Mean Absolute Value of the Difference Between Blood Glucose Meter (BGMS) Results and Corresponding YSI Blood Glucose (BG) Results in the Low BG Range(<70 mg/dL)|"Using samples with BG < 70 mg/dL, the Mean Absolute Value of the Differences Between BGM system readings and the YSI laboratory reference values were compared. MAD was calculated from the sum of all |(BG meter)-(BG reference)| assessments, divided by the number of assessments. Each evaluable sample was tested on all 6 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MAD value indicates smaller difference between meter value and the reference value. Higher MAD value indicates larger difference between meter value and the reference value."|6 hours|Same number (135) of BG results was possible for each BGMS. A capillary sample was collected from each subject at 3 different times during the visit to obtain natural capillary blood samples with a range of glucose concentrations. Subjects provided 85 unmodified capillary samples <70 mg/dL and 50 samples were modified by glycolyzing them.||mg/dL|Participants|Standard Error|Least Squares Mean
676987|NCT01614600|Primary|Mean Change From Baseline in Contact Lens-Related Dryness Symptoms at Week 1 and Week 2|Contact lens symptoms were evaluated using the Contact Lens Dry Eye Questionnaire (CLDEQ). Subjects rated 8 common contact lens-related ocular surface dryness symptoms at Baseline, Week 1, and Week 2 using a 5-point scale (1=never or not at all intense, 5=constantly or very intense). A scoring algorithm was used to calculate a composite score for each visit for all symptoms (-6.5 to 10). A higher composite score would indicate more contact lens related dry eye and a lower score, less contact lens related dry eye.|Baseline, Week 1, Week 2|Per Protocol: All enrolled and dispensed participants, minus any major protocol deviators as determined by masked review.||Units on a scale||Standard Deviation|Mean
676988|NCT01614574|Secondary|Change From Baseline in CCL18 Levels||Baseline to week 51|||(ng/mL)||Standard Deviation|Mean
676989|NCT01614574|Secondary|Change From Baseline in Plasma Chitotriosidase Levels||Baseline to week 51|||(nmol/mL/h)||Standard Deviation|Mean
676990|NCT01614574|Secondary|Change From Baseline in Spleen Volume, Normalized to Body Weight||Baseline to week 51|||(% of Body Weight)||Standard Deviation|Mean
676991|NCT01614574|Secondary|Change From Baseline in Liver Volume, Normalized to Body Weight||Baseline to week 51|||(% of Body Weight)||Standard Deviation|Mean
676992|NCT01614574|Secondary|Change From Baseline in Platelet Count||Baseline to week 51|||(x 10`{super 9}/L)||Standard Deviation|Mean
676993|NCT01614574|Secondary|Change From Baseline in Hemoglobin Concentration||Baseline to week 51|||(g/dL)||Standard Deviation|Mean
676994|NCT01614574|Primary|Number of Patients With Concomitant Medication||Baseline to week 51|||participants|||Number
676995|NCT01614574|Primary|Number of Infusion- Related Adverse Events||Baseline to week 51|||events|||Number
676996|NCT01614574|Primary|Development of Anti-velaglucerase Alfa Antibody||Baseline to week51|||participants|||Number
676997|NCT01614574|Primary|Number of Treatment Emergent Adverse Events (TEAE)||Baseline to week 51|||events|||Number
676998|NCT01614574|Primary|Number of Severe Adverse Events (SAE)||Baseline to week 51|||events|||Number
676999|NCT01614509|Primary|Changes of Central Retinal Thickness|Changes of central retinal thickness on optical coherence tomography (OCT) at baseline and 1, 3, 6 month after injection|baseline, 1, 3, 6 months after injection|Participants who were finished 6 months follow up period.||micrometer||Standard Deviation|Mean
677000|NCT01614509|Secondary|Additional Intravitreal Bevacizumab Injection|Comparison of the additional intravitreal bevacizumab injection of intravitreal bevacizumab monotherapy or combined therapy of posterior subtenon triamcinolone acetonide and intravitreal bevacizumab during 6 months|6 months|We evaluated mean times of additional intravitreal injection because of recurrent macular edema within participants who who were finished 6 months follow up periods.||times of injection||Standard Deviation|Mean
677001|NCT01614470|Secondary|Part 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: any adverse change from subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording/clinical laboratory assessment which occurs during course of study, whether it is considered related to study drug or not. SAE: medical event or condition, which falls into any of following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolonged hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect, important medical event.|Part 2: Week 20 up to Week 40|Safety Set for Part 2 included all subjects who received at least 1 dose of study drug (ivacaftor).||participants|||Number
677003|NCT01614470|Secondary|Part 2: Change From Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score Through 24 Weeks of Treatment (Week 36 Visit)|The CFQ-R is a validated patient-reported outcome measuring health-related quality of life for subjects with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life. Change in CFQ-R respiratory domain score over 24 weeks of ivacaftor treatment (from Week 12 [Part 1: Treatment Period 2] through Week 36 [Part 2]) was reported for subjects who received ivacaftor in Part 1: Treatment Period 2 as per planned analysis. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug during Part 1: Treatment Period 2.|Baseline (pre-dose Week 12), Week 36|FAS for Part 2: all randomized subjects who received at least 1 dose of study drug (ivacaftor). Only subjects who were randomized to receive ivacaftor during Part 1: Treatment Period 2 were to be analyzed for this measure.||units on a scale||Standard Deviation|Mean
677004|NCT01614470|Secondary|Part 1: Change From Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score Through Week 8|The CFQ-R is a validated patient-reported outcome measuring health-related quality of life for subjects with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug during study Part 1.|Part 1: Baseline (pre-dose Day 1), Week 8|"FAS for Part 1: all randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo). Here, n signifies those subjects who were evaluable for this measure at given time point for each group, respectively."||units on a scale||Standard Deviation|Mean
677005|NCT01614470|Secondary|Part 2: Change From Baseline in Sweat Chloride Through 24 Weeks of Treatment (Week 36 Visit)|Sweat samples were collected using an approved Macroduct (Wescor, Logan, Utah) collection device. A volume of greater than or equal to (>=) 15 microliter was required for determination of sweat chloride. Change in sweat chloride over 24 weeks of ivacaftor treatment (from Week 12 [Part 1: Treatment Period 2] through Week 36 [Part 2]) was reported for subjects who received ivacaftor in Part 1: Treatment Period 2 as per planned analysis. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug during Part 1: Treatment Period 2.|Baseline (pre-dose Week 12), Week 36|"FAS for Part 2: all randomized subjects who received at least 1 dose of study drug (ivacaftor). Only subjects who were randomized to receive ivacaftor during Part 1: Treatment Period 2 were to be analyzed for this measure. Here n signifies those subjects who were evaluable for this measure at given time point."||mmol/L||Standard Deviation|Mean
677006|NCT01614470|Primary|Part 2: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through 24 Weeks of Treatment (Week 36 Visit)|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, and height). The Hankinson standard was used for male subjects 18 years and older and female subjects 16 years and older. The Wang standard was used for male subjects aged 6 to 17 years and for female subjects aged 6 to 15 years. Absolute change in percent predicted FEV1 over 24 weeks of ivacaftor treatment (from Week 12 [Part 1: Treatment Period 2] through Week 36 [Part 2]) was reported for subjects who received ivacaftor in Part 1: Treatment Period 2, as per planned analysis. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug during Part 1: Treatment Period 2.|Baseline (pre-dose Week 12), Week 36|FAS for Part 2: all randomized subjects who received at least 1 dose of study drug (ivacaftor). Only subjects who were randomized to receive ivacaftor during Part 1: Treatment Period 2 were to be analyzed for this measure.||percent predicted of FEV1||Standard Deviation|Mean
677007|NCT01614470|Secondary|Part 1: Change From Baseline in Sweat Chloride Through Week 8|Sweat samples were collected using an approved Macroduct (Wescor, Logan, Utah) collection device. A volume of greater than or equal to (>=) 15 microliter was required for determination of sweat chloride. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug during study Part 1.|Part 1: Baseline (pre-dose Day 1), Week 8|"FAS for Part 1: all randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo). Here, n signifies those subjects who were evaluable for this measure at given time point for each group, respectively."||millimole per liter (mmol/L)||Standard Deviation|Mean
677008|NCT01614470|Secondary|Part 2: Change From Baseline in Body Mass Index (BMI) at 24 Weeks of Treatment (Week 36 Visit)|BMI was defined as weight in kg divided by height in m^2. Change in BMI over 24 weeks of ivacaftor treatment (from Week 12 [Part 1: Treatment Period 2] through Week 36 [Part 2]) was reported for subjects who received ivacaftor in Part 1: Treatment Period 2 as per planned analysis. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug during Part 1: Treatment Period 2.|Baseline (pre-dose Week 12), Week 36|FAS for Part 2: all randomized subjects who received at least 1 dose of study drug (ivacaftor). Only subjects who were randomized to receive ivacaftor during Part 1: Treatment Period 2 were to be analyzed for this measure.||kg/m^2||Standard Deviation|Mean
677009|NCT01614470|Secondary|Part 1: Change From Baseline in Body Mass Index (BMI) at Week 8|BMI was defined as weight in kilogram (kg) divided by height in meters^2 (m^2). Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug during study Part 1.|Part 1: Baseline (pre-dose Day 1), Week 8|"FAS for Part 1: all randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo). Here, n signifies those subjects who were evaluable for this measure at given time point for each group, respectively."||kg/m^2||Standard Deviation|Mean
677010|NCT01614470|Primary|Part 1: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through Week 8|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, and height). The Hankinson standard was used for male subjects 18 years and older and female subjects 16 years and older. The Wang standard was used for male subjects aged 6 to 17 years and for female subjects aged 6 to 15 years. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug during study Part 1.|Part 1: Baseline (pre-dose Day 1), Week 8|"FAS for Part 1: all randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo). Here, n signifies those subjects who were evaluable for this measure at given time point for each group, respectively."||percent predicted of FEV1||Standard Deviation|Mean
677011|NCT01614457|Secondary|Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: any untoward medical occurrence, including clinically significant clinical laboratory assessments which occurs during course of study, whether it is considered related to study drug or not. SAE: medical event or condition, which falls into any of following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolonged hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect, important medical event.|Baseline up to follow-up (3 to 4 weeks after last dose [last dose = Week 24])|Safety Set included all subjects who received at least 1 dose of study drug (ivacaftor or placebo).||participants|||Number
677012|NCT01614457|Secondary|Time to First Pulmonary Exacerbation|Number of events (pulmonary exacerbation) during the pre-specified time intervals were reported. A subject without an exacerbation before withdrawal from the study was considered censored at the time of withdrawal, and a subject without an exacerbation who completes the study period was considered censored at the end of the analysis period.|Day 0 to 15, Day 16 to 56, Day 57 to 112, Day 113 to 168|FAS included all randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo).||events|||Number
677013|NCT01614457|Secondary|Change From Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score Through Week 24|The CFQ-R is a validated subject-reported outcome measuring health-related quality of life for subjects with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life|Baseline, Week 24|"FAS included all randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo). Here, Number of participants analyzed signifies those subjects who were evaluable for this measure."||units on a scale||Standard Error|Least Squares Mean
677014|NCT01614457|Secondary|Change From Baseline in Sweat Chloride Through Week 24|Sweat samples were collected using an approved Macroduct (Wescor, Logan, Utah) collection device. A volume of greater than or equal to (>=) 15 microliter was required for determination of sweat chloride.|Baseline, Week 24|"FAS included all randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo). Here, Number of participants analyzed signifies those subjects who were evaluable for this measure."||millimole per liter (mmol/L)||Standard Error|Least Squares Mean
677015|NCT01614457|Secondary|Change From Baseline in Body Mass Index (BMI) at Week 24|BMI was defined as weight in kilogram (kg) divided by height in square meter (m^2).|Baseline, Week 24|FAS included all randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo).||kg/m^2||Standard Error|Least Squares Mean
677016|NCT01614457|Primary|Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through Week 24|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, and height). The Hankinson standard was used for male subjects 18 years and older and female subjects 16 years and older. The Wang standard was used for male subjects aged 6 to 17 years and for female subjects aged 6 to 15 years.|Baseline, Week 24|Full Analysis Set (FAS) included all randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo).||percent predicted of FEV1||Standard Error|Least Squares Mean
677017|NCT01614249|Primary|Change in BDI-II Depressive Symptom Scores|Depressive symptoms were assessed by Beck Depression Inventory Second Edition (BDI-II) Scoring scale at Baseline and end of study during the 8- week study period. The BDI-II Scale is a 21-item scoring tool which measures the existence and severity of symptoms of depression. Each of the 21 items on BDI-II tool represent a depressive symptom. The symptoms are each scored on a 4-point Likert scale of 0 to 3 (0=symptom is absent; 3=symptom is severe).Scores for each symptom are added up to obtain the total scores for all 21 items, which are interpreted as follows: Scores of 0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression and 29-63: severe depression. The change in BDI-II scores were computed from post-intervention scores at week 8 and baseline BDI-II scores at week 0.|8 weeks|Only participants who completed the 8-weeks trial period were included in the final analysis of primary outcome. Per protocol analysis Post-intervention BDI-II scores at week 8 minus baseline BDI-II scores at week 0||scores on BDI-II scale||95% Confidence Interval|Mean
677019|NCT01613599|Secondary|Incidence Rate of Serious Infections in Participants Who Received Re-treatment With MabThera/Rituximab|"A serious infection was defined as an infection that was a serious adverse event (SAE) or a non-SAE infection that required treatment with intravenous antimicrobials. An SAE was defined as any adverse event that fulfilled at least one of the following criteria:
Was fatal (results in death)
Was life-threatening
Required in-patient hospitalization or prolongation of existing hospitalization
Resulted in persistent or significant disability/incapacity
Was a congenital anomaly/birth defect
Was medically significant or required intervention to prevent one or other of the outcomes listed above.
Multiple events reported in the same participant were counted multiple times in the calculation of incidence. Incidence rate is defined as events per 100 patient years."|From first dose until participant withdrawal or the date of latest participant visit (up to 37 months)|Re-treated safety population included all participants who received more than one course of rituximab.||events per 100 patient year|Total Patient-years at Risk|95% Confidence Interval|Number
677020|NCT01613599|Secondary|Incidence Rate of Serious Adverse Events in Participants Who Received Re-treatment With MabThera/Rituximab|"An SAE was defined as any adverse event that fulfilled at least one of the following criteria:
Was fatal (results in death)
Was life-threatening
Required in-patient hospitalization or prolongation of existing hospitalization
Resulted in persistent or significant disability/incapacity
Was a congenital anomaly/birth defect
Was medically significant or required intervention to prevent one or other of the outcomes listed above.
Multiple events reported in the same participant were counted multiple times in the calculation of incidence. Incidence rate is defined as events per 100 patient years."|From first dose until participant withdrawal or the date of latest participant visit (up to 37 months)|Re-treated safety population included all participants who received more than one course of rituximab.||events per 100 patient year|Total Patient-years at Risk|95% Confidence Interval|Number
677079|NCT01613248|Primary|Number of Participants Who Discontinued From Study Due to Adverse Events||Up to 5 weeks post-dose|ASaT population included all randomized participants who received at least one dose of study treatment.||participants|||Number
677022|NCT01613599|Secondary|Incidence Rate of Serious Adverse Events|"An SAE was defined as any adverse event that fulfilled at least one of the following criteria:
Was fatal (results in death)
Was life-threatening
Required in-patient hospitalization or prolongation of existing hospitalization
Resulted in persistent or significant disability/incapacity
Was a congenital anomaly/birth defect
Was medically significant or required intervention to prevent one or other of the outcomes listed above.
Multiple events reported in the same participant were counted multiple times in the calculation of incidence. Incidence rate is defined as events per 100 patient years."|From first dose until participant withdrawal or the date of latest participant visit (up to 37 months)|Safety population included all participants who received any dose of rituximab and whose safety data was verifiable.||events per 100 patient year|Total Patient-years at Risk|95% Confidence Interval|Number
677023|NCT01613599|Secondary|Incidence Rate of Malignancy, Excluding Non-melanoma Skin Cancer|Multiple events reported in the same participant were counted multiple times in the calculation of incidence. Incidence rate is defined as events per 100 patient years.|From first dose until participant withdrawal or the date of latest participant visit (up to 37 months)|Safety population included all participants who received any dose of rituximab and whose safety data was verifiable.||events per 100 patient year|Total Patient-years at Risk|95% Confidence Interval|Number
677024|NCT01613599|Secondary|Incidence Rate of Serious Vascular Adverse Events|"A serious vascular adverse event was defined as an SAE coded to the MedDRA vascular system organ class. An SAE was defined as any adverse event that fulfilled at least one of the following criteria:
Was fatal (results in death)
Was life-threatening
Required in-patient hospitalization or prolongation of existing hospitalization
Resulted in persistent or significant disability/incapacity
Was a congenital anomaly/birth defect
Was medically significant or required intervention to prevent one or other of the outcomes listed above.
Multiple events reported in the same participant were counted multiple times in the calculation of incidence. Incidence rate is defined as events per 100 patient years."|From first dose until participant withdrawal or the date of latest participant visit (up to 37 months)|Safety population included all participants who received any dose of rituximab and whose safety data was verifiable.||events per 100 patient year|Total Patient-years at Risk|95% Confidence Interval|Number
677025|NCT01613599|Secondary|Percentage of Participants With Any Serious Adverse Events During or Within 24 Hours After Any Rituximab Infusion|"An SAE was defined as any adverse event that fulfilled at least one of the following criteria:
Was fatal (results in death)
Was life-threatening
Required in-patient hospitalization or prolongation of existing hospitalization
Resulted in persistent or significant disability/incapacity
Was a congenital anomaly/birth defect
Was medically significant or required intervention to prevent one or other of the outcomes listed above."|From the start of an infusion up to 24 hours following infusion completion (up to 37 months)|Safety population included all participants who received any dose of rituximab and whose safety data was verifiable.||percentage of participants|||Number
677026|NCT01613599|Secondary|Incidence Rate of Serious Cardiac Adverse Events|"A serious cardiac adverse event was defined as an SAE that was coded to the Medical Dictionary for Regulatory Activities (MedDRA) cardiac system organ class. An SAE was defined as any adverse event that fulfilled at least one of the following criteria:
Was fatal (results in death)
Was life-threatening
Required in-patient hospitalization or prolongation of existing hospitalization
Resulted in persistent or significant disability/incapacity
Was a congenital anomaly/birth defect
Was medically significant or required intervention to prevent one or other of the outcomes listed above.
Multiple events reported in the same participant were counted multiple times in the calculation of incidence. Incidence rate is defined as events per 100 patient years."|From first dose until participant withdrawal or the date of latest participant visit (up to 37 months)|Safety population included all participants who received any dose of rituximab and whose safety data was verifiable.||events per 100 patient year|Total Patient-years at Risk|95% Confidence Interval|Number
677027|NCT01613599|Secondary|Percentage of Participants With a Serious Infusion-related Reaction|"A serious infusion-related reaction was defined as an SAE during or within 24 hours after any rituximab infusion and considered infusion related by the Principal Investigator. An SAE was defined as any adverse event that fulfilled at least one of the following criteria:
Was fatal (results in death)
Was life-threatening
Required in-patient hospitalization or prolongation of existing hospitalization
Resulted in persistent or significant disability/incapacity
Was a congenital anomaly/birth defect
Was medically significant or required intervention to prevent one or other of the outcomes listed above."|From the start of an infusion up to 24 hours following infusion completion (up to 37 months)|Safety population included all participants who received any dose of rituximab and whose safety data was verifiable.||percentage of participants|||Number
677028|NCT01613599|Primary|Incidence Rate of Serious Infections|"A serious infection was defined as an infection that was a serious adverse event (SAE) or a non-SAE infection that required treatment with intravenous antimicrobials. An SAE was defined as any adverse event that fulfilled at least one of the following criteria:
Was fatal (results in death)
Was life-threatening
Required in-patient hospitalization or prolongation of existing hospitalization
Resulted in persistent or significant disability/incapacity
Was a congenital anomaly/birth defect
Was medically significant or required intervention to prevent one or other of the outcomes listed above.
Multiple events reported in the same participant were counted multiple times in the calculation of incidence. Incidence rate is defined as events per 100 patient years."|From first dose until participant withdrawal or the date of latest participant visit (up to 37 months)|Safety population included all participants who received any dose of rituximab and whose safety data was verifiable.||events per 100 patient year|Total Patient-years at Risk|95% Confidence Interval|Number
677029|NCT01613417|Secondary|Accuracy for Tumor Characterization|Blinded reader assessment of accuracy of tumor characterization (benign/malignant) - patient level assessment|5-10 minutes Postdose|Subjects with histologically confirmed lesions||participants|||Number
677030|NCT01613417|Secondary|Lesion Detection|Lesion detection rate by contrast agent and reader|5-10 minutes Postdose|Per protocol patients with histologically confirmed lesions||participant exams|||Number
677031|NCT01613417|Secondary|Percentage Signal Intensity Enhancement on Postdose Images|Mean difference in percentage signal intensity enhancement on postdose T1-weighted SE/FSE images (ProHance - Gadovist/Gadavist)|5-10 minutes Postdose|Per-protocol population||percentage signal intensity enhancement|Participants|Standard Deviation|Mean
677032|NCT01613417|Secondary|Lesion to Background Ratio on Post T1-weighed Spin Echo Images|Mean of difference in signal intensity postdose (ProHance - Gadovist/Gadavist)|5-10 minutes Postdose|Per-protocol population||signal intensity|Participants|Standard Deviation|Mean
677033|NCT01613417|Secondary|Lesion Contrast Enhancement|Assessed by 3 blinded readers for each of the 198 patients who had post-dose exams for both ProHance and Gadovist/Gadavist. Readers assessed whether images with ProHance were preferred or images with Gadovist/Gadavist were preferred, or whether images after both exams were considered equal.|Comparison of image sets obtained within 2 to 14 days|||participant exams|Participants||Number
677034|NCT01613417|Secondary|Extent of Disease|Assessed by 3 blinded readers for each of the 198 patients who had post-dose exams for both ProHance and Gadovist/Gadavist. Readers assessed whether images with ProHance were preferred or images with Gadovist/Gadavist were preferred, or whether images after both exams were considered equal.|Comparison of image sets obtained within 2 to 14 days|||participant exams|Participants||Number
677035|NCT01613417|Secondary|Lesion Internal Morphology|Assessed by 3 blinded readers for each of the 198 patients who had post-dose exams for both ProHance and Gadovist/Gadavist. Readers assessed whether images with ProHance were preferred or images with Gadovist/Gadavist were preferred, or whether images after both exams were considered equal.|Comparison of image sets obtained within 2 to 14 days|||participant exams|Participants||Number
677036|NCT01613417|Secondary|Lesion Border Delineation|Assessed by 3 blinded readers for each of the 198 patients who had post-dose exams for both ProHance and Gadovist/Gadavist. Readers assessed whether images with ProHance were preferred or images with Gadovist/Gadavist were preferred, or whether images after both exams were considered equal.|Comparison of image sets obtained within 2 to 14 days|||participant exams|Participants||Number
677037|NCT01613417|Primary|Global Diagnostic Preference Between the Two Exams|Assessed by 3 blinded readers for each of the 198 patients who had post-dose exams for both ProHance and Gadovist/Gadavist. Readers assessed whether images with ProHance were preferred or images with Gadovist/Gadavist were preferred, or whether images after both exams were considered equal.|Comparison of image sets obtained within 2 to 14 days|Per Protocol=patients who completed both exams, had global paired image data available, and had no major protocol violations||participant exams|Participants||Number
677038|NCT01613378|Secondary|Number of Participants With Changes in Severity of Extra-Articular Manifestations at 12 Months|"The severity of extra-articular RA manifestations ascertained were the nodules, Raynaud’s phenomenon, secondary Sjogren’s syndrome, pulmonary fibrosis, pericarditis, polyneuropathy, scleritis, severe cutaneous vasculitis, weight loss and anemia. Percentages are based on the total number of participants who responded YES to changes in extra- articular RA manifestations (new presence or change in severity) since the last visit. NA=Not applicable"|At 12 months|Full analysis set (FAS) population consisted of all participants included in the study who received at least one dose of Tocilizumab (n=198). Only participants who completed the assessment of Extra-Articular Manifestations were included in this analysis.||participants|||Number
677039|NCT01613378|Secondary|Percentage of Participants With Changes in Extra-Articular Manifestations at 12 Months|The extra-articular RA manifestations ascertained were the nodules, Raynaud’s phenomenon, secondary Sjogren’s syndrome, pulmonary fibrosis, pericarditis, polyneuropathy, scleritis, severe cutaneous vasculitis, weight loss and anemia. Percentages are based on the total number of participants with available data.|At 12 months|Full analysis set (FAS) population consisted of all participants included in the study who received at least one dose of Tocilizumab (n=198). Only participants who completed the assessment of Extra-Articular Manifestations were included in this analysis.||percentage of participants|||Number
677040|NCT01613378|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR)|The erythrocyte sedimentation rate (ESR) was analyzed at the site using the kit provided by the central laboratory. A reduction in the level of ESR was considered an improvement.|From baseline to Month 12|Full analysis set (FAS) population consisted of all participants included in the study who received at least one dose of Tocilizumab (n=198). Only participants who completed the ESR assessment were included in this analysis.||mm/hr||Standard Deviation|Mean
677041|NCT01613378|Secondary|Change From Baseline in C-Reactive Protein (CRP)|The serum concentration of C-reactive protein (CRP) was measured. A reduction in the level of CRP was considered an improvement.|From baseline to Month 12|Full analysis set (FAS) population consisted of all participants included in the study who received at least one dose of Tocilizumab (n=198). Only participants who completed the CRP assessment were included in this analysis.||mg/L||Standard Deviation|Mean
677042|NCT01613378|Secondary|Change From Baseline in Patient Assessment of Fatigue (Visual Analog Scale, VAS)|With VAS, participants specify their level of agreement to a statement by indicating a position along a continuous line between two endpoints, with 0 being the lowest level and 100 being the highest level of fatigue.|From baseline to Month 12|Full analysis set (FAS) population consisted of all participants included in the study who received at least one dose of Tocilizumab (n=198). Only participants who completed the Patient Assessment of Fatigue on the VAS were included in this analysis.||units on a scale||Standard Deviation|Mean
677043|NCT01613378|Secondary|Change From Baseline in Patient Assessment of Pain (Visual Analog Scale, VAS)|With VAS, participants specify their level of agreement to a statement by indicating a position along a continuous line between two endpoints, with 0 being the lowest level and 100 being the highest level of pain.|From baseline to Month 12|Full analysis set (FAS) population consisted of all participants included in the study who received at least one dose of Tocilizumab (n=198). Only participants who completed the Assessment of Pain on the VAS were included in this analysis.||units on a scale||Standard Deviation|Mean
677044|NCT01613378|Secondary|Change From Baseline in Physician Global Assessment of Disease Activity (Visual Analog Scale, VAS)|With VAS, physicians specify their level of agreement to a statement by indicating a position along a continuous line between two endpoints, with 0 being the lowest level and 100 being the highest level of disease activity.|From baseline to Month 12|Full analysis set (FAS) population consisted of all participants included in the study who received at least one dose of Tocilizumab (n=198). Only participants who completed the Assessment of Disease Activity on the VAS were included in this analysis.||units on a scale||Standard Deviation|Mean
677045|NCT01613378|Secondary|Change From Baseline in Patient Global Assessment of Disease Activity (Visual Analog Scale, VAS)|With VAS, participants specify their level of agreement to a statement by indicating a position along a continuous line between two endpoints, with 0 being the lowest level and 100 being the highest level of disease activity.|From baseline to Month 12|Full analysis set (FAS) population consisted of all participants included in the study who received at least one dose of Tocilizumab (n=198). Only participants who completed the Assessment of Disease Activity on the VAS were included in this analysis.||units on a scale||Standard Deviation|Mean
677046|NCT01613378|Secondary|Change From Baseline in Duration of Morning Stiffness (Visual Analog Scale, VAS)|With VAS, participants specify their level of agreement to a statement by indicating a position along a continuous line between two endpoints, with 0 being the lowest level and 100 being the highest level of morning stiffness.|From baseline to Month 12|Full analysis set (FAS) population consisted of all participants included in the study who received at least one dose of Tocilizumab (n=198). Only participants who completed the assessment of Duration of Morning Stiffness on the VAS were included in this analysis.||units on a scale||Standard Deviation|Mean
677047|NCT01613378|Secondary|Change From Baseline in Disease Activity Score 28 (DAS28)|The DAS28 scale is a combined index for measuring disease activity in rheumatoid arthritis. Scores range from 0 to 10, with higher scores representing more disease activity.|From baseline to Month 12|Full analysis set (FAS) population consisted of all participants included in the study who received at least one dose of Tocilizumab (n=198). Only participants who completed the DAS28 assessment were included in this analysis.||units on a scale||Standard Deviation|Mean
677048|NCT01613378|Secondary|Change From Baseline in Swollen Joint Count (SJC)|Following an assessment of 66 joints for swelling, joints were classified as swollen or not swollen by the investigator.|From baseline to Month 12|Full analysis set (FAS) population consisted of all participants included in the study who received at least one dose of Tocilizumab (n=198). Only participants who completed the Swollen Joint Count were included in this analysis.||swollen joints||Standard Deviation|Mean
677049|NCT01613378|Secondary|Change From Baseline in Tender Joint Count (TJC)|Following an assessment of 68 joints for tenderness, joints were classified as tender or not tender by the investigator.|From baseline to Month 12|Full analysis set (FAS) population consisted of all participants included in the study who received at least one dose of Tocilizumab (n=198). Only participants who completed the Tender Joint Count were included in this analysis.||tender joints||Standard Deviation|Mean
677050|NCT01613378|Primary|Percentage of Participants on Tocilizumab Treatment at 6 Months After Treatment Initiation||At 6 months|All participants enrolled in the study.||percentage of participants||95% Confidence Interval|Number
677051|NCT01613339|Secondary|Activities-specific Balance Confidence Scale|16 item questionnaire that investigates balance self-efficacy. Each items is a question; How secure are you that you will not fall when you...sweep the floor? The participant are asked to grade his/hers feeling of secutiry from 0, 10, 20 and so on up to 100. 0 is regarded low balance self-efficacy. The item responses are summed and divided by 16.|Change from baseline in Activities-specific Balance confidence scale at 9 weeks|||units on a scale||Standard Deviation|Mean
677052|NCT01613339|Primary|Bergs Balance Scale|"Test of functional balance. Includes 14 items all graded 0-4 where 0 indicate larger impairment. Total score is used here, maximum 56 and minimum 0.
The Berg balance scale was developed for older patients but is a much used meausure of dynamic and static functional balance."|Change from baseline in Bergs balance scale at 9 weeks|||units on a scale||Standard Deviation|Mean
677053|NCT01613339|Secondary|Timed Up and Go Test|test of functional mobility. Time is taken in seconds. The participants sits on a chair with armrests are then asked to rise, walk 3 meters, turn and walk back and sit down.|Change from baseline in Timed Up and Go test at 9 weeks|||seconds||Standard Deviation|Mean
677054|NCT01613326|Secondary|Mean Daily, Daytime and Nighttime (Combined) Symptom Scores Over the 12 Week Treatment Period|Participants completed eDiaries providing scores 0 to 3 for symptoms: Cough and wheeze (none, mild, moderate, severe); sputum volume (none, less than 5 mL, 5-25 mL, >25 mL); sputum color (none, white-grey, yellow, green); lowest level of activity causing breathlessness (never or only when running, when walking uphill or upstairs, when walking on flat ground, at rest). Symptoms in the morning, for the previous night (no waking due to symptoms, woke up once due to symptoms, woke up more than once due to symptoms, woke up frequently or could not sleep due to symptoms). Symptoms experienced during the day that had prevented them for performing normal activities (not at all, a little, quite a lot, completely). The mean change from baseline in the total scores and in the individual scores was summarized by treatment. Only participants with a value at both baseline and post-baseline were included. Possible total scores 0-18 (night); 0-36 (day). A higher score means worsening of symptoms.|12 weeks|The per-protocol set included all randomized patients who received at least one dose of study drug. Only patients with a value at both baseline and post-baseline are included.||units on a scale||Standard Deviation|Mean
677055|NCT01613326|Secondary|Event Free Rate at Weeks 4, 8 and 12 After Treatment|Event free rate was calculated as a percentage of participants who did not experience any moderate or severe COPD exacerbation leading to hospitalization/treatment with systemic corticosteroids/treatment with antibiotics. The event free rate reflects the percent of patients who did NOT have an exacerbation by 4, 8 and 12 weeks. Event-free rates are calculated at the end of the specified weeks (i.e. Day 29, Day 57 and Day 85) by the Kaplan Meier method.|Weeks 4, 8 and 12|The per-protocol set included all randomized patients who received at least one dose of study drug, with available data and without any major protocol deviations and described as patients with moderate to severe exacerbations were included in this analysis.||percentage of participants||95% Confidence Interval|Number
677056|NCT01613326|Secondary|Standardized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) (5 Min-4 h) Post-dose|"Forced Expiratory Volume in one second (FEV1) was measured with spirometry conducted according to internationally accepted standards.
Area Under the Curve (AUC) is calculated using the trapezoidal rule using the existing FEV1 measurements (i.e., the missing FEV1 measurements are not interpolated).
ANCOVA model: FEV1 AUC = treatment + baseline FEV1 + baseline Inhaled corticosteroid (ICS) use (Yes/No) + FEV1 reversibility components + baseline smoking status + region + center(region). Center is included as a random effect nested within region."|Day 1 and week 12|The per-protocol set included all randomized patients who received at least one dose of study drug, with available data and without any major protocol deviations.||Liters||Standard Error|Least Squares Mean
677080|NCT01613248|Primary|Number of Participants With One or More Adverse Events Within 14 Days Post-Dose|An AE is any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a sponsor product, whether or not considered related to the use of the product.|Up to 14 days post-dose|ASaT population included all randomized participants who received at least one dose of study treatment.||participants|||Number
677907|NCT01603875|Secondary|Side Effects of the Vaccines. These Include Pain, Swelling, Redness, Myalgia, Rash, Fever. Serious Adverse Events Will Also be Recorded.|"There are five injections, on day 0, 7, 28, 360 and 363.
The side effects will be record in number and percentage."|up to 7 days after each injection||||||
677057|NCT01613326|Secondary|Forced Vital Capacity (FVC) at Each Time-point by Visit|Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed via spirometry. ANCOVA model: FVC = treatment + baseline FVC + baseline Inhaled corticosteroid (ICS) use (Yes/No) + FEV1 reversibility components + baseline smoking status + region + center(region). Center is included as a random effect nested within region.|(5,15,30 min, 1, 2,3,4 h, 23h 15 min and 23h 45 min postdose of Day 1), (-45, -15 min predose, 5,15,30 min, 1h, 23h 15 min and 23h 45 min postdose of Week 4), (-45, -15 min predose, 5,15,30 min, 1, 2, 3,4 h, 23h 15 min and 23h 45 min postdose of Week 12)|The per-protocol set included all randomized patients who received at least one dose of study drug, with available data and without any major protocol deviations||Liters||Standard Error|Least Squares Mean
677058|NCT01613326|Secondary|Forced Expiratory Volume in 1 Second (FEV1) at Each Time-point by Visit|Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEV1 was analyzed using Analysis of Covariance (ANCOVA) model: FEV1 = treatment + baseline FEV1 + baseline Inhaled corticosteroid (ICS) use (Yes/No) + FEV1 reversibility components + baseline smoking status + region + center(region). Center is included as a random effect nested within region.|(5,15,30 min, 1, 2,3,4 h, 23h 15 min and 23h 45 min postdose of Day 1), (-45, -15 min predose, 5,15,30 min, 1h, 23h 15 min and 23h 45 min postdose of Week 4), (-45, -15 min predose, 5,15,30 min, 1, 2, 3,4 h, 23h 15 min and 23h 45 min postdose of Week 12)|The per-protocol set included all randomized patients who received at least one dose of study drug, with available data and without any major protocol deviations||Liters||Standard Error|Least Squares Mean
677059|NCT01613326|Secondary|Inspiratory Capacity (IC) at Each Time-point, by Visit|IC was measured with spirometry conducted according to internationally accepted standards. ANCOVA model: IC = treatment + baseline IC + baseline Inhaled corticosteroid (ICS) use (Yes/No) + FEV1 reversibility components + baseline smoking status + region + center(region). Center is included as a random effect nested within region.|(25 min, 1 h 55 min, 3 h 55 min, 23 h 40 min Day 1), (-20 min, 25 min, 23 h 40 min Week 4),(-20 min, 25 min, 1 h 55 min, 3 h 55 min, 23 h 40 min Week 12)|The per-protocol set included all randomized patients who received at least one dose of study drug, with available data and without any major protocol deviations||Liters||Standard Error|Least Squares Mean
677060|NCT01613326|Secondary|Peak Forced Expiratory Volume in 1 Second (FEV1) During 5 Min to 4 Hours Post-dose, at Day 1 and Week 12|Spirometry was conducted according to internationally accepted standards. Peak FEV1 is the maximum FEV1 recorded during first 4 hours post dose. ANCOVA model: Peak FEV1 = treatment + baseline FEV1 + baseline Inhaled corticosteroid (ICS) use (Yes/No) + FEV1 reversibility components + baseline smoking status + region + center (region). Center is included as a random effect nested within region. This analysis excludes values within 6 hours of rescue medication use or 7 days of systemic corticosteroid use.|5 min to 4 hours post-dose at Day 1 and Week 12|The per-protocol set included all randomized patients who received at least one dose of study drug, with available data and without any major protocol deviations||Liters||Standard Error|Least Squares Mean
677061|NCT01613326|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 1 and Week 4|"FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing.
Trough FEV1 is defined as the average of the post-dose 23 h 15 min and the 23 h 45 min FEV1 values. Trough assessments taken outside 22 h 45 min - 24 h 15 min are excluded from this analysis.
ANCOVA model: Trough FEV1 = treatment + baseline FEV1 + baseline Inhaled corticosteroid (ICS) use (Yes/No) + FEV1 reversibility components + baseline smoking status + region + center(region). Center is included as a random effect nested within region."|Day 1 and Week 4|The per-protocol set included all randomized patients who received at least one dose of study drug, with available data and without any major protocol deviations or who did not take study drug as per protocol in the 14 day period prior to trough.||Liters||Standard Error|Least Squares Mean
677062|NCT01613326|Secondary|Change From Baseline in Mean Daily Number of Puffs of Rescue Medication Used Over the 12 Week Treatment|"A day with no rescue medication use is defined from the diary data as any day where the patient recorded no rescue medicine use during the previous 12 hours.
Baseline mean daily, daytime and nighttime (combined) number of puffs is defined as the average of the respective number of puffs. Only patients with a value at both baseline and post-baseline visits were included."|Baseline and Day 1 to Week 12|The per-protocol set included all randomized patients who received at least one dose of study drug, with a value at both baseline and post-baseline visits were included.||puffs||Standard Deviation|Mean
677063|NCT01613326|Secondary|St. George's Respiratory Questionnaire Total Score After 12 Weeks of Treatment|St. George's Respiratory Questionnaire (SGRQ) is a health related quality of life questionnaire consisting of 51 items in three areas: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). The total score is 0 to 100 with a higher score indicating poorer health status. ANCOVA model: SGRQ total score = treatment + baseline SGRQ score + baseline ICS use (Yes/No) + FEV1 reversibility components + baseline smoking status + region + center (region).|Week 12|The per-protocol set included all randomized patients who received at least one dose of study drug, with available data and without any major protocol deviations.||Units on a scale||Standard Error|Least Squares Mean
677064|NCT01613326|Secondary|Transition Dyspnea Index (TDI) Focal Score After 4 Weeks and 12 Weeks of Treatment|"Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement from baseline.
ANCOVA model: TDI focal score = treatment + Baseline dyspnea index (BDI) + baseline Inhaled corticosteroid (ICS) use (Yes/No) + FEV1 reversibility components + baseline smoking status + region + center(region). Center is included as a random effect nested within region."|Weeks 4 and 12|The per-protocol set included all randomized patients who received at least one dose of study drug, with available data and without any major protocol deviations.||Units on a scale||Standard Error|Least Squares Mean
677104|NCT01613027|Secondary|Reasons for Discontinuation of Treatment by Month 6|Reasons for discontinuation from baseline to Month 6 are presented as the number of participants who discontinued treatment by category of reason for discontinuation.|Baseline to Month 6|Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.||participants|||Number
677065|NCT01613326|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) After 12 Weeks of Treatment (Analysis of Superiority)|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. The trough in FEV1 was defined as the mean of two measurements at 23h 15min and 23h 45min post dosing. ANCOVA model: Trough FEV1 = treatment + baseline FEV1 + baseline Inhaled corticosteroid (ICS) use (Yes/No) + FEV1 reversibility components + baseline smoking status + region + center(region). This analysis excluded values within 6 hours of rescue medication use or 7 days of systemic corticosteroid.|Week 12|The Full Analysis Set (FAS) includes all randomized patients who received at least one dose of study drug and had available data for analysis.||Liters||Standard Error|Least Squares Mean
677066|NCT01613326|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) After 12 Weeks of Treatment (Non-inferiority Analysis)|Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. The trough in FEV1 was defined as the mean of two measurements at 23hours 15min and 23 hours 45min post dosing. ANCOVA model: Trough FEV1 = treatment + baseline FEV1 + baseline Inhaled corticosteroid (ICS) use (Yes/No) + FEV1 reversibility components + baseline smoking status + region + center (region). This analysis excluded values within 6 hours of rescue medication use or 7 days of systemic corticosteroid use.|Week 12|The per-protocol set included all randomized patients who received at least one dose of study drug, with available data and without any major protocol deviations or who did not take study drug as per protocol in the 14 day period prior to trough.||Liters||Standard Error|Least Squares Mean
677067|NCT01613313|Secondary|Relative Change in Volume of the Lipoma|A secondary outcome is the relative change in volume of the lipoma as determined by MRI. This outcome will be analyzed as the change from baseline to 6 months post injection.|Baseline and 6 months post injection of study drug|Analysis is based on the population that consists of all subjects who are enrolled and received administration of study drug||Percent reduction from baseline||Standard Deviation|Mean
677068|NCT01613313|Primary|Change in Visible Surface Area of the Lipoma|The primary efficacy outcome is the visible surface area of the lipoma measured as the longest dimension (length) times the longest dimension perpendicular to length (width). Visible surface area will be determined by caliper and will be analyzed as the percent change from baseline at the 6-month post injection visit.|Baseline and Six months post injection of study drug|Analysis population consists of all subjects who were enrolled and received the administration of study drug.||Percent change from baseline||Standard Deviation|Mean
677069|NCT01613248|Secondary|Percentage of Participants Reporting TMF at 2-48 Hours Post-Dose|TMF at 2-48 hours post-dose was defined as SPF with no photophobia, phonophobia, nausea, or vomiting during the 2 to 48 hour period after dosing with study medication.|2-48 hours post-dose|Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis.||percentage of participants||95% Confidence Interval|Number
677070|NCT01613248|Secondary|Percentage of Participants Reporting TMF at 2-24 Hours Post-Dose|TMF at 2-24 hours post-dose was defined as SPF with no photophobia, phonophobia, nausea, or vomiting during the 2 to 24 hour period after dosing with study medication.|2-24 hours post-dose|Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis.||percentage of participants||95% Confidence Interval|Number
677071|NCT01613248|Secondary|Percentage of Participants Reporting Total Migraine Freedom (TMF) at 2 Hours Post-Dose|TMF at 2 hours post dose was defined as PF with no photophobia, phonophobia, nausea, or vomiting at 2 hours post-dose.|2 hours post-dose|Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis.||percentage of participants||95% Confidence Interval|Number
677072|NCT01613248|Secondary|Percentage of Participants Reporting SPR 2-48 Hours Post-Dose|SPR was defined as PR at 2 hours post-dose, with no administration of any rescue medication and with no occurrence of a moderate/severe headache during the 48 hour period after dosing with study medication.|2-48 hours post-dose|Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis.||percentage of participants||95% Confidence Interval|Number
677073|NCT01613248|Secondary|Percentage of Participants Reporting Sustained Pain Relief (SPR) 2-24 Hours Post-Dose|SPR was defined as PR at 2 hours post-dose, with no administration of any rescue medication and with no occurrence of a moderate/severe headache during the 24 hour period after dosing with study medication.|2-24 hours post-dose|Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis.||percentage of participants||95% Confidence Interval|Number
677074|NCT01613248|Secondary|Percentage of Participants Reporting SPF 2-48 Hours Post-Dose|SPF was defined as PF at 2 hours post-dose, with no administration of any rescue medication and with no occurrence of a mild/moderate/severe headache during the 48 hour period after dosing with study medication.|2-48 hours post-dose|Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis.||percentage of participants||95% Confidence Interval|Number
677075|NCT01613248|Secondary|Percentage of Participants Reporting Sustained Pain Freedom (SPF) 2-24 Hours Post-Dose|SPF was defined as PF at 2 hours post-dose, with no administration of any rescue medication and with no occurrence of a mild/moderate/severe headache during the 24 hour period after dosing with study medication.|2-24 hours post-dose|Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis.||percentage of participants||95% Confidence Interval|Number
677076|NCT01613248|Secondary|Percentage of Participants Reporting Absence of Nausea at 2 Hours Post-Dose||2 hours post-dose|Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis.||percentage of participants||95% Confidence Interval|Number
677077|NCT01613248|Secondary|Percentage of Participant Reporting Absence of Photophobia at 2 Hours Post-Dose|Photophobia is sensitivity to bright light.|2 hours post-dose|Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis.||percentage of participants||95% Confidence Interval|Number
677081|NCT01613248|Primary|Number of Participants With One or More Adverse Events Within 48 Hours Post-Dose|An AE is any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a sponsor product, whether or not considered related to the use of the product.|Up to 48 hours post-dose|All Subjects as Treated (ASaT) population included all randomized participants who received at least one dose of study treatment.||participants|||Number
677082|NCT01613248|Primary|Percentage of Participants Reporting Pain Relief (PR) at 2 Hours Post-Dose|PR was defined as a reduction of a moderate or severe migraine headache (Grade 2 or 3) at Baseline to a mild headache or no headache (Grade 1 or 0) 2 hours post-dose. Headache severity was reported by the participant using a 4-point scale where: 0=no pain, 1=mild pain, 2=moderate pain and 3=severe pain.|2 hours post-dose|Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis.||percentage of participants||95% Confidence Interval|Number
677083|NCT01613248|Primary|Percentage of Participants Reporting Pain Freedom (PF) at 2 Hours Post-Dose|PF was defined as a reduction in headache severity from Grade 2 or 3 at Baseline to Grade 0. Headache severity was reported by the participant using a 4-point scale where: 0=no pain, 1=mild pain, 2=moderate pain and 3=severe pain.|2 hours post-dose|Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis.||percentage of participants||95% Confidence Interval|Number
677084|NCT01613131|Primary|Fatigue|The Fatigue Severity Scale (FSS) was used to determine the degree to which night-time sleep difficulty manifested as daytime sleepiness. The FSS is a 9-item scale assessing fatigue over the past week, on a 7-point Likert scale (ranging from 1-7). It is scored by averaging the individual item scores, with higher scores indicating greater fatigue. Scores greater than or equal to 5.5 are generally indicative of insomnia with impaired daytime functioning.|Day 140|3 women in the Mirena + Estradiol Gel arm, and 5 women in the Mirena + Placebo Gel did not provide complete data; thus, were not included in the analysis for this timepoint.||scores on a scale||Standard Error|Mean
677085|NCT01613131|Primary|Fatigue|The Fatigue Severity Scale (FSS) was used to determine the degree to which night-time sleep difficulty manifested as daytime sleepiness. The FSS is a 9-item scale assessing fatigue over the past week, on a 7-point Likert scale (ranging from 1-7). It is scored by averaging the individual item scores, with higher scores indicating greater fatigue. Scores greater than or equal to 5.5 are generally indicative of insomnia with impaired daytime functioning.|Day 90|3 women in the Mirena + Estradiol Gel arm, and 6 women in the Mirena + Placebo Gel did not provide complete data; thus, were not included in the analysis for this timepoint.||scores on a scale||Standard Error|Mean
677086|NCT01613131|Primary|Depression|The Center for Epidemiologic Studies-Depression Scale (CES-D) is a 20-item scale with 4-point Likert responses indicating frequency of symptoms over past week. Scores range from 0-60, with scores >16 considered indicative of depressive symptoms.|Day 140|3 women in the Mirena + Estradiol Gel arm, and 6 women in the Mirena + Placebo Gel did not provide complete data; thus, were not included in the analysis for this timepoint.||scores on a scale||Standard Error|Mean
677087|NCT01613131|Primary|Depression|The Center for Epidemiologic Studies-Depression Scale (CES-D) is a 20-item scale with 4-point Likert responses indicating frequency of symptoms over past week. Scores range from 0-60, with scores >16 considered indicative of depressive symptoms.|Day 90|4 women in the Mirena + Estradiol Gel arm, and 5 women in the Mirena + Placebo Gel did not provide complete data; thus, were not included in the analysis for this timepoint.||scores on a scale||Standard Error|Mean
677088|NCT01613131|Primary|Hot Flashes|The Hot Flash Related Daily Interference Scale (HFRDIS) is a ten item scale measuring degree to which hot flashes interfere with 9 daily activities (work, social, leisure, sleep, mood, concentration, relations, sexuality, enjoyment of life, overall quality of life) over the prior week, each scored on a 10 point Likert scale. The total score is reported, and scores range from 0-100, 100 being the worst outcome.|Day 140|3 women in the Mirena + Estradiol Gel arm, and 5 women in the Mirena + Placebo Gel did not provide data; thus, were not included in the analysis for this timepoint.||scores on a scale||Standard Error|Mean
677089|NCT01613131|Primary|Hot Flashes|The Hot Flash Related Daily Interference Scale (HFRDIS) is a ten item scale measuring degree to which hot flashes interfere with 9 daily activities (work, social, leisure, sleep, mood, concentration, relations, sexuality, enjoyment of life, overall quality of life) over the prior week, each scored on a 10 point Likert scale. The total score is reported, and scores range from 0-100, 100 being the worst outcome.|Day 90|3 women in the Mirena + Estradiol Gel arm, and 5 women in the Mirena + Placebo Gel did not provide complete data; thus, were not included in the analysis for this timepoint.||scores on a scale||Standard Error|Mean
677090|NCT01613131|Primary|Sleep|The Pittsburgh Sleep Quality Index (PSQI) is a 19-item scale designed to measure general sleep disturbances over the previous month (sleep wake patterns, duration of sleep, sleep latency, impact of poor sleep on daytime functioning, assesses specific problems contributing to poor sleep, including pain, urination, breathing difficulty, snoring, dreams, temperature). The global score is reported and ranges from 1-21, with higher scores being indicative of poorer sleep.|Day 140|5 women in the Mirena + Estradiol Gel arm, and 7 women in the Mirena + Placebo Gel did not provide complete data; thus, were not included in the analysis for this timepoint.||scores on a scale||Standard Error|Mean
677091|NCT01613131|Primary|Sleep|The Pittsburgh Sleep Quality Index (PSQI) is a 19-item scale designed to measure general sleep disturbances over the previous month (sleep wake patterns, duration of sleep, sleep latency, impact of poor sleep on daytime functioning, assesses specific problems contributing to poor sleep, including pain, urination, breathing difficulty, snoring, dreams, temperature). The global score is reported and ranges from 1-21, with higher scores being indicative of poorer sleep.|Day 90|3 women in the Mirena + Estradiol Gel arm, and 5 women in the Mirena + Placebo Gel did not provide complete data; thus, were not included in the analysis for this timepoint.||scores on a scale||Standard Error|Mean
677105|NCT01613027|Secondary|Percentage of Participants Who Remained on Treatment or Discontinued Treatment by Month 6 and Month 12||Up to 12 months|Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.||percentage of participants|||Number
677668|NCT01606228|Secondary|Daytime Drowsiness at Day 90|The daytime drowsiness is measured by a self-administered scale in which patients indicate how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 100 (all the time).|Day 90|Per Protocol (PP) population||scores on a scale||Standard Deviation|Mean
677092|NCT01613131|Primary|Fatigue|The Fatigue Severity Scale (FSS) was used to determine the degree to which night-time sleep difficulty manifested as daytime sleepiness. The FSS is a 9-item scale assessing fatigue over the past week, on a 7-point Likert scale (ranging from 1-7). It is scored by averaging the individual item scores, with higher scores indicating greater fatigue. Scores greater than or equal to 5.5 are generally indicative of insomnia with impaired daytime functioning.|Day 0|One woman in the Mirena + Placebo Gel arm did not provide complete data for this outcome measure; thus she was not included in the analysis for this timepoint.||scores on a scale||Standard Error|Mean
677093|NCT01613131|Primary|Depression|The Center for Epidemiologic Studies-Depression Scale (CES-D) is a 20-item scale with 4-point Likert responses indicating frequency of symptoms over past week. Scores range from 0-60, with scores >16 considered indicative of depressive symptoms.|Day 0|Two women in the Mirena + Placebo Gel did not provide complete data for this outcome measure; thus they were not included in the analysis for this timepoint.||scores on a scale||Standard Error|Mean
677094|NCT01613131|Primary|Sleep|The Pittsburgh Sleep Quality Index (PSQI) is a 19-item scale designed to measure general sleep disturbances over the previous month (sleep wake patterns, duration of sleep, sleep latency, impact of poor sleep on daytime functioning, assesses specific problems contributing to poor sleep, including pain, urination, breathing difficulty, snoring, dreams, temperature). The global score is reported and ranges from 1-21, with higher scores being indicative of poorer sleep.|Day 0|||scores on a scale||Standard Error|Mean
677095|NCT01613131|Primary|Hot Flashes|The Hot Flash Related Daily Interference Scale (HFRDIS) is a ten item scale measuring degree to which hot flashes interfere with 9 daily activities (work, social, leisure, sleep, mood, concentration, relations, sexuality, enjoyment of life, overall quality of life) over the prior week, each scored on a 10 point Likert scale. The total score is reported, and scores range from 0-100, 100 being the worst outcome.|Day 0|||scores on a scale||Standard Error|Mean
677096|NCT01613027|Secondary|Percentage of Serious ADRs|"Percentage of serious ADRs resolved and ongoing at the time of study completion was reported.
An ADR was defined as any noxious and unintended response to a medicinal product related to any dose."|Up to 12 months|Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.||percentage of serious ADRs|Participants||Number
677097|NCT01613027|Secondary|Percentage of Serious AEs|"Percentage of serious AEs resolved and ongoing at the time of study completion was reported.
An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product."|Up to 12 months|Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.||percentage of serious AEs|Participants||Number
677098|NCT01613027|Secondary|Percentage of Non-Serious ADRs|"Percentage of non-serious ADRs at the time of study completion was reported.
An ADR was defined as any noxious and unintended response to a medicinal product related to any dose."|Up to 12 months|Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.||percentage of non-serious ADRs|Participants||Number
677099|NCT01613027|Secondary|Percentage of Non-Serious AEs|"Percentage of non-serious AEs resolved and ongoing at the time of study completion were reported.
An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product."|Up to 12 months|Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.||percentage of non-serious AEs|Participants||Number
677100|NCT01613027|Secondary|Percentage of Participants With Any Non-Serious AE and Any Serious AE by Intensity|"Percentage of participants with any non-serious AE and any serious AE by intensity (mild, moderate, severe) was reported.
An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product."|Up to 12 months|Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.||percentage of participants|||Number
677101|NCT01613027|Secondary|Percentage of Participants With Adverse Events (AEs) and Adverse Drug Reactions (ADRs)|An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An ADR was defined as any noxious and unintended response to a medicinal product related to any dose. AEs of special interest includes progressive multifocal leukoencephalopathy (PML), any encephalopathy, hepatitis B or hepatitis B reactivation, gastrointestinal perforation, tuberculosis (TB) or TB reactivation, opportunistic infections, and malignancies.|Up to 12 months|Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.||percentage of participants|||Number
677102|NCT01613027|Secondary|Percentage of Participants With Clinically Meaningful Improvement From Baseline in Modified Health Assessment Questionnaire (M-HAQ)|"The M-HAQ is a participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. A negative change from baseline indicates improvement.
Clinically meaningful improvement was defined as minimum clinically significant reduction from baseline of ≥0.22 at the respective time point."|Up to 12 months|Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab. Data for change from baseline at Month 6 and Month 12 are included for participants with available data at each time point.||percentage of participants||95% Confidence Interval|Number
677103|NCT01613027|Secondary|Reasons for Discontinuation of Treatment by Month 12|Reasons for discontinuation from baseline to Month 12 are presented as the number of participants who discontinued treatment by category of reason for discontinuation.|Baseline to Month 12|Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.||participants|||Number
677669|NCT01606228|Secondary|Daytime Drowsiness at Baseline|The daytime drowsiness is measured by a self-administered scale in which patients indicate how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 100 (all the time).|Baseline|Per Protocol (PP) population||scores on a scale||Standard Deviation|Mean
677106|NCT01613027|Secondary|Change From Baseline in C-reactive Protein (CRP) at Month 6 and Month 12|C-reactive protein (CRP) is a blood test marker for inflammation in the body. Normal CRP levels are below 5.0 milligrams per liter (mg/L). A decrease from baseline indicates improvement.|Baseline, Month 6, Month 12|Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab. Data at Month 6 and Month 12 are included for participants who had assessments for CRP.||mg/L||Standard Deviation|Mean
677107|NCT01613027|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 6 and Month 12|ESR is an direct measure of how much inflammation is in the body. The normal range is 0-22 mm/hour for men and 0-29 mm/hour for women. A decrease from baseline indicates improvement.|Baseline, Month 6, Month 12|Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.||mm/hour||Standard Deviation|Mean
677108|NCT01613027|Secondary|Change From Baseline in Tender Joint Count (TJC) at Month 6 and Month 12|TJC was determined by examining 28 and 68 joints and identifying the joints that were painful under pressure or to passive motion. Tenderness was recorded on the joint assessment form at baseline, no tenderness = 0, tenderness = 1. A decrease from baseline indicates improvement.|Baseline, Month 6, Month 12|Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.||tender joints||Standard Deviation|Mean
677109|NCT01613027|Secondary|Change From Baseline in Swollen Joint Count (SJC) at Month 6 and Month 12|SJC was determined by examining 28 and 66 joints and identifying when swelling was present. Swelling was recorded on the joint assessment form at baseline, no swelling = 0, swelling =1. The sum of swollen joints, each, ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status. A decrease from baseline indicates improvement.|Baseline, Month 6, Month 12|Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.||swollen joints||Standard Deviation|Mean
677110|NCT01613027|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Response at Month 6 and Month 12|EULAR response was calculated as the difference between DAS28-ESR scores at baseline and Month 6, and baseline and Month 12, and reported as the percentage of participants with response overall, good response, moderate response, and no response measured at each time point. Good responders = decrease from baseline >1.2 with a DAS28 score of ≤3.2; moderate responders = decrease from baseline >1.2 with a DAS28 score of >3.2, or decrease from baseline >0.6 to ≤1.2 with a DAS28 score of ≤5.1; non-responders = decrease from baseline ≤0.6 or decrease from baseline >0.6 and ≤1.2 with a DAS28 score of >5.1.|Baseline, Month 6, Month 12|Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.||percentage of participants||95% Confidence Interval|Number
677111|NCT01613027|Primary|Change From Baseline in Disease Activity Score Based on 28-joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR) at Month 6 and Month 12|DAS28-ESR is a measure of the participant's disease activity and was calculated using the swollen joint count of 28 joints (SJC28), tender joint count of 28 joints (TJC28), erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient’s global assessment of disease activity (100-millimeter [mm] horizontal visual analog scale with 0=no disease activity to 100=maximum disease activity). DAS28-ESR scores range from 0 to 10, with higher scores corresponding to greater disease activity.|Baseline, Month 6, Month 12|Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.||units on a scale||Standard Deviation|Mean
677112|NCT01613014|Primary|Weekly Percentage of Heaving Drinking Days|"The primary objective of this study is to assess the efficacy of ABT-436 to reduce the weekly percentage of heavy drinking days (reduction in drinking) in subjects with alcohol dependence confirmed by DSM-IV-TR criteria. A “heavy drinking day” is 4 or more drinks per drinking day for women and 5 or more drinks per drinking day for men.
The outcome measure was averaged across weeks 2-12."|Weeks 2-12|Models are based on a mITT population that included subjects who received at least one dose of medication (N=144; ABT-436=73, placebo=71). One additional placebo subject had no drinking data during the maintenance period, and one ABT-436 subject was missing data on a baseline covariate, resulting in an analyzable N=142 (ABT-436=72, placebo=70).||weekly percentage of heavy drinking days||95% Confidence Interval|Least Squares Mean
677113|NCT01612858|Secondary|Change in Hepatic Fat From Baseline to Week 12 Post-treatment With an Insulin Sensitizing Agent|Change in hepatic fat was measured after 12 weeks of treatment with metformin or pioglitazone using magnetic resonance spectroscopy|12 weeks|Only participants with baseline and post insulin sensitizing treatment magnetic resonance spectrosocpy were included in this analysis.||percentage of hepatic fat||Standard Deviation|Mean
677114|NCT01612858|Primary|Change in Insulin Sensitivity From Baseline to Week 12 Post-treatment With Insulin Sensitizing Agent|Change in insulin sensitivity measured by 2 hour euglycemic-hyperinsulinemic clamp from baseline to week 12 post treatment with metformin or pioglitazone|3 months|Only participants with baseline and post insulin-sensitizing treatment euglycemic-hyperinsulinemic clamp were included in this analysis||mg/kg lean body mass/min||Standard Deviation|Mean
677129|NCT01612702|Secondary|Wound Complication|Number of participants with a sinus tract communicating with the prosthesis; a pathogen was isolated by culture from tissue or fluid samples taken from the affected joint; tests revealed elevated serum erythrocyte sedimentation rate (ESR) or serum C-reactive protein (CRP) concentration with elevated synovial white blood cell (WBC) count or neutrophil percentage; or pus discharge from the affected joint was present within 30 days after total knee arthroplasty were measured.|within 30 days after surgery|||participant|||Number
677130|NCT01612702|Secondary|Pain Level|A blinded investigator asked participants to recall the most severe pain level during 6 to 24 hour after surgery using with a visual analogue scale that ranged from 0 (no pain) to 10 (worst imaginable pain).|6 to 24 hours after surgery|||units on a scale||Standard Deviation|Mean
677131|NCT01612702|Primary|Incidence of Nausea and Vomiting|A clinical investigator who is blinded to randomization assessed the incidence of postoperative nausea which defined as subjective unpleasant sensation associated with awareness of the urge to vomit and as emetic episode and vomiting|within 72 hours after surgery|||percentage of participant||95% Confidence Interval|Number
677146|NCT01612494|Primary|Change in Pain|Self-reported pain assessment using the Wong-Baker Faces Pain Rating Scale. There are 6 faces with 5 intervals. Faces are numbered 0 to 10. Maximum score is the 6th face/10. Minimum score is the first face/0. Increasing faces represent increase in pain, decreasing faces represent decrease in pain. No subscales were included.|Following therapy to 2-3 days post discharge|||units on a scale||Standard Deviation|Mean
677132|NCT01612676|Secondary|Adverse Effects on Lab Parameters, Vital Signs and Electrocardiogram|Significant changes for vital signs (blood pressure, heart rate, mean arterial pressure), electrocardiogram (ECG), and laboratory parameters (clinical chemistry, haematology, haemostasis, and urinary parameters).|Day 1 up to Day 7, and at follow-up assessments performed 24-72 hours after end of IMP infusion|The safety analysis set comprised of all allocated and dosed patients and were analyzed according to the actual dosing regimen received.||patients|||Number
677133|NCT01612676|Secondary|Mortality|Collection of data on mortality was performed on Day 28 in addition to the collection of data on time of stay in intensive care unit and hospital.|Day 1 up to Day 28|Full analysis set (FAS) was the primary dataset of interest. FAS comprised of all patients who were dosed.||patients|||Number
677134|NCT01612676|Primary|Time to Septic Shock Resolution|"The Kaplan-Meyer estimation of time to out of septic shock was estimated where time to (first) septic shock resolution was defined as time of end of infusion regimen. Intermittent off treatment periods were regarded as part of the shock duration.
Time to all but one patient out of septic shock is presented."|Day 1 up to Day 28|Full analysis set (FAS) was the primary dataset of interest. FAS comprised of all patients who were dosed.||Hours|||Number
677135|NCT01612676|Primary|Infusion Rate of Norepinephrine|Norepinephrine was infused as required to maintain the target mean arterial pressure, if the highest infusion rate allowed of experimental drug FE 202158 did not provide adequate vasopressor support. Infusion rates and all changes in infusion rates of norepinephrine were recorded continuously during the 7 day maximum treatment period.|Day 1 up to Day 7 post-infusion (Data collected at Day 1 at 1, 2, 3, 4, 5, 6, 9, 12, 15, 18 and 24 h, Day 2 at 36 and 48 h, Day 3 at 72 h, Day 4 at 96 h, Day 5 at 120 h, Day 6 at 144 h, and Day 7 at 168 h). Data is presented for specific time points.|Full analysis set (FAS) was the primary dataset of interest. FAS comprised of all patients who were dosed. One patient in the 7.5 ng/kg/min group started the vasopressor support without prior administration of norepinephrine, and MAP was adequately controlled as needed.||µg/kg/min||Standard Deviation|Mean
677136|NCT01612676|Primary|Cumulative Dose of Norepinephrine|Norepinephrine was infused as required to maintain the target mean arterial pressure, if the highest infusion rate allowed of experimental drug FE 202158 did not provide adequate vasopressor support. Cumulative dose of norepinephrine was calculated from Day 1 up to Day 7.|Day 1 up to Day 7 post-infusion (Data collected at Day 1 at 1, 2, 3, 4, 5, 6, 9, 12, 15, 18 and 24 h, Day 2 at 36 and 48 h, Day 3 at 72 h, Day 4 at 96 h, Day 5 at 120 h, Day 6 at 144 h, and Day 7 at 168 h). Data is presented for specific time points.|Full analysis set (FAS) was the primary dataset of interest. FAS comprised of all patients who were dosed. One patient in the 7.5 ng/kg/min group started the vasopressor support without prior administration of norepinephrine, and MAP was adequately controlled as needed.||µg/kg||60% Confidence Interval|Mean
677137|NCT01612676|Primary|Infusion Rate of FE 202158|Infusion rate of FE 202158 was presented from Day 1 up to Day 7.|Day 1 up to Day 7 post-infusion (Data collected at Day 1 at 1, 2, 3, 4, 5, 6, 9, 12, 15, 18 and 24 h, Day 2 at 36 and 48 h, Day 3 at 72 h, Day 4 at 96 h, Day 5 at 120 h, Day 6 at 144 h, and Day 7 at 168 h). Data is presented for specific time points.|Full analysis set (FAS) was the primary dataset of interest. FAS comprised of all patients who were dosed.||ng/kg/min||Standard Deviation|Mean
677138|NCT01612676|Primary|Cumulative Dose of FE 202158|Cumulative dose of FE 202158 was calculated from Day 1 up to Day 7.|Day 1 up to Day 7 post-infusion (Data collected at Day 1 at 1, 2, 3, 4, 5, 6, 9, 12, 15, 18 and 24 h, Day 2 at 36 and 48 h, Day 3 at 72 h, Day 4 at 96 h, Day 5 at 120 h, Day 6 at 144 h, and Day 7 at 168 h). Data is presented for specific time points.|Full analysis set (FAS) was the primary dataset of interest. FAS comprised of all patients who were dosed.||ng/kg||60% Confidence Interval|Mean
677139|NCT01612676|Secondary|Graded Morbidity|Collection of data on graded morbidity was performed on Day 28 in addition to the collection of data on time of stay in intensive care unit and hospital.|Day 1 up to Day 28|Full analysis set (FAS) was the primary dataset of interest. FAS comprised of all patients who were dosed.||patients|||Number
677140|NCT01612676|Secondary|Morbidity Assessment|Percentage of all the “Days alive and out/free of” intensive care unit, hospital, dialysis, or ventilation within Day 28 were summarized. Patients dying before or at Day 28 were counted as zero.|Day 1 up to Day 28|Full analysis set (FAS) was the primary dataset of interest. FAS comprised of all patients who were dosed.||percentage of days within 28 days|||Number
677141|NCT01612676|Secondary|Summary of Investigator Reported Outcomes|Investigator reported outcome on FE 202158 performance. Answers were graded on a visual analogue scale (VAS) from 0 to 10, 0 being the worst and 10 being the best outcome.|Day 1 up to Day 2|Full analysis set (FAS) was the primary dataset of interest. FAS comprised of all patients who were dosed.||Score on scale||Standard Deviation|Mean
677142|NCT01612676|Secondary|Fluid Balance|The fluid balance (accumulated input/output) was recorded in 24-hour collecting periods when the patient was in the intensive care unit and during the infusion of FE 202158.|Day 1 up to Day 7 post-infusion (Data collected on Day 1 at 24 h, Day 2 at 48 h, Day 3 at 72 h, Day 4 at 96 h, Day 5 at 120 h, Day 6 at 144 h, and Day 7 at 168 h). Data is presented for specific time points.|Full analysis set (FAS) was the primary dataset of interest. FAS comprised of all patients who were dosed.||mL/kg||60% Confidence Interval|Mean
677143|NCT01612676|Secondary|Urinary Output|The urinary output was recorded every 24 hours up to Day 7, or as long as the patient was in intensive care unit.|Day 1 up to Day 7 post-infusion (Data collected on Day 1 at 24 h, Day 2 at 48 h, Day 3 at 72 h, Day 4 at 96 h, Day 5 at 120 h, Day 6 at 144 h, and Day 7 at 168 h). Data is presented for specific time points.|Full analysis set (FAS) was the primary dataset of interest. FAS comprised of all patients who were dosed.||mL/kg||60% Confidence Interval|Mean
677144|NCT01612676|Primary|Percentage of Patients Maintaining Target/Adequate Mean Arterial Pressure (MAP>60 mmHg) Without Norepinephrine|Mean arterial pressure (MAP) was measured intra-arterially on a continuous basis. Success percentage of patients maintaining target/adequate MAP (>60 mmHg) without norepinephrine is presented.|Day 1 up to Day 7 post-infusion (Data collected at Day 1 at 1, 2, 3, 4, 5, 6, 9, 12, 15, 18 and 24 h, Day 2 at 36 and 48 h, Day 3 at 72 h, Day 4 at 96 h, Day 5 at 120 h, Day 6 at 144 h, and Day 7 at 168 h). Data is presented for specific time points.|Full analysis set (FAS) was the primary dataset of interest. FAS comprised of all patients who were dosed.||Percentage of patients||60% Confidence Interval|Number
677145|NCT01612494|Secondary|Change in Nausea and Vomiting||from initial symptoms to 2-3 days post discharge||||||
677947|NCT01603420|Secondary|Assessment of Total Number of Survival Events With Comparison of Group Arms|The number of deaths in both arms will be assessed.|at study closure (22 months)|||participants|||Number
677147|NCT01612221|Secondary|Transcriptional Markers of UV-induced Oxidative Stress in Nevi|Biomarkers susceptible to UV-induced damage protected by NAC (N-acetylcysteine) in irradiated and unirradiated nevi|3.5 years|One subject with low-risk MC1R randomized to drug was excluded because the lesions removed were seborrheic keratoses and not nevi.||markers of UV-induced oxidative stress||Standard Deviation|Mean
677148|NCT01612221|Primary|UV-induced Oxidative Stress in Irradiated and Unirradiated Nevi|Differences in the median percent nevus with 8-OG expression in UV-irradiated nevi compares with unirradiated nevi.|3.5 years|One subject with low-risk MC1R randomized to drug was excluded from both analyses because the lesions removed were seborrheic keratoses and not nevi, and 2 subjects (one high-risk MC1R randomized to drug and one low-risk MC1R randomized to placebo) were excluded from analysis of 8-OG because there was insufficient tissue.||percentage of 8-OG expression in nevi||Standard Deviation|Mean
677149|NCT01612156|Secondary|Embarrassment With Pelvic Floor Examination|The participants will be asked to report their level of embarrasment during the exam using a Likert scale from 1 (no embarrassment) to 5 (most embarrasment possible) at 30 minutes after completion of the exam.|30 minutes|||On 5 point Likert scale||Full Range|Median
677150|NCT01612156|Primary|Pain During the Pelvic Floor Examination|"Subjects will be asked to report their pain level using the Wong Baker pain scale at the beginning of the exam, after a cotton tipped swab test, after the urodynamic catheters are placed in the urethra, and then 30 minutes after the completion of the exam.
The Wong Baker pain scale ranges from 0 (no pain) to 10 (worst pain possible)."|30 minutes after completion of exam|||units on Wong Baker pain scale||Standard Deviation|Mean
677151|NCT01612000|Primary|The Difference in Geometric Mean Titer Between rHA Formulated in an oil-in- Water Adjuvant (SE) Compared to a rHA Antigen Alone.||42 Days|All subjects who received both doses of study vaccine and had pre- and post-immunization immunogenicity data for the time period summarized.||titer||95% Confidence Interval|Geometric Mean
677152|NCT01612000|Secondary|Long-term Safety|Incidence of Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCIs) and Adverse Events of Special Interest (AESIs) over 12 months following vaccination. Study subjects were followed every three months (for one year following Day 42) by telephone and visit for reports of SAEs, NOCIs, and AESIs.|13 Months|All randomized subjects who received at least one dose of study vaccine and provided any safety data following vaccination.||participants|||Number
677153|NCT01612000|Secondary|Reactogenicity Immediately After Each Injection, Extending to Day 7.|Solicited events of local and systemic reactogenicity Days 0-7. These events are expected to occur and not considered or recorded as Adverse Events.|7 Days|All randomized subjects who received at least one dose of study vaccine and provided any safety data following vaccination.||participants|||Number
677154|NCT01612000|Primary|The Difference in Seroconversion/Immunogenicity Between rHA Formulated in an oil-in- Water Adjuvant (SE) Compared to a rHA Antigen Alone.|Immunogenicity was assessed by measuring the percentage of subjects in each group exhibiting seroconversion on Day 42. The treatment groups that received adjuvanted rHA were evaluated against a non-adjuvanted rHA treatment group for whether they demonstrated seroconversion rates and 95% confidence intervals.|42 Days|All subjects who received both doses of study vaccine and had pre- and post-immunization immunogenicity data for the time period summarized.||percentage of participants||95% Confidence Interval|Number
677155|NCT01611974|Secondary|Half-Life (T½) of Maribavir|For the subset of participants who had pharmacokinetic (PK) profiling performed, non-compartmental PK analyses were used to determine Cmax, time to Cmax (tmax), time of last non-zero concentration (tlast), area under the plasma concentration versus time curve from the time of dosing to the last measurable concentration (AUClast), and half-life (t½). Values below the LLOQ post-baseline were replaced with a value of 0 ug/mL. Values below the LLOQ at baseline were replaced with zero as it was assumed that subjects had no levels of maribavir at baseline. At the designated timepoints, the PK sample was obtained 2-4 hours after the dose of study drug; for subjects who were inpatients, a pre-dose PK sample also was collected. These samples were not required at Day 8 and Week 4 for subjects who had PK profiles performed on those days.|pre-dose and 1, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 8 and the Week 4 visit|The Pharmacokinetic Profile Population, defined as all participants in the ITT-S Population who had plasma samples drawn and tested for maribavir concentrations.||hours||Standard Deviation|Mean
677156|NCT01611974|Secondary|Area Under The Plasma Concentration Versus Time Curve From The Time of Dosing to The Last Measurable Concentration (AUClast) of Maribavir|For the subset of participants who had pharmacokinetic (PK) profiling performed, non-compartmental PK analyses were used to determine Cmax, time to Cmax (tmax), time of last non-zero concentration (tlast), area under the plasma concentration versus time curve from the time of dosing to the last measurable concentration (AUClast), and half-life (t½). Values below the LLOQ post-baseline were replaced with a value of 0 ug/mL. Values below the LLOQ at baseline were replaced with zero as it was assumed that subjects had no levels of maribavir at baseline. At the designated timepoints, the PK sample was obtained 2-4 hours after the dose of study drug; for subjects who were inpatients, a pre-dose PK sample also was collected. These samples were not required at Day 8 and Week 4 for subjects who had PK profiles performed on those days.|pre-dose and 1, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 8 and the Week 4 visit|The Pharmacokinetic Profile Population, defined as all participants in the ITT-S Population who had plasma samples drawn and tested for maribavir concentrations.||h*ug/mL||Standard Deviation|Mean
677157|NCT01611974|Secondary|Time of Last Non-Zero Concentration (Tlast) of Maribavir|For the subset of participants who had pharmacokinetic (PK) profiling performed, non-compartmental PK analyses were used to determine Cmax, time to Cmax (tmax), time of last non-zero concentration (tlast), area under the plasma concentration versus time curve from the time of dosing to the last measurable concentration (AUClast), and half-life (t½). Values below the LLOQ post-baseline were replaced with a value of 0 ug/mL. Values below the LLOQ at baseline were replaced with zero as it was assumed that subjects had no levels of maribavir at baseline. At the designated timepoints, the PK sample was obtained 2-4 hours after the dose of study drug; for subjects who were inpatients, a pre-dose PK sample also was collected. These samples were not required at Day 8 and Week 4 for subjects who had PK profiles performed on those days.|pre-dose and 1, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 8 and the Week 4 visit|The Pharmacokinetic Profile Population, defined as all participants in the ITT-S Population who had plasma samples drawn and tested for maribavir concentrations.||hours||Standard Deviation|Mean
677948|NCT01603420|Secondary|Assessment of Total Number of Salvage Androgen Deprivation Use With Comparison of Arms.|The total number of subjects with salvage androgen deprivation use will be assessed.|At study closure (22 months)|||participants|||Number
677158|NCT01611974|Secondary|Time to Maximum Concentration (Tmax) of Maribavir|For the subset of participants who had pharmacokinetic (PK) profiling performed, non-compartmental PK analyses were used to determine Cmax, time to Cmax (tmax), time of last non-zero concentration (tlast), area under the plasma concentration versus time curve from the time of dosing to the last measurable concentration (AUClast), and half-life (t½). Values below the LLOQ post-baseline were replaced with a value of 0 ug/mL. Values below the LLOQ at baseline were replaced with zero as it was assumed that subjects had no levels of maribavir at baseline. At the designated timepoints, the PK sample was obtained 2-4 hours after the dose of study drug; for subjects who were inpatients, a pre-dose PK sample also was collected. These samples were not required at Day 8 and Week 4 for subjects who had PK profiles performed on those days.|pre-dose and 1, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 8 and the Week 4 visit|The Pharmacokinetic Profile Population, defined as all participants in the ITT-S Population who had plasma samples drawn and tested for maribavir concentrations.||hours||Standard Deviation|Mean
677159|NCT01611974|Secondary|Maximum Concentration (Cmax) of Maribavir|For the subset of participants who had pharmacokinetic (PK) profiling performed, non-compartmental PK analyses were used to determine Cmax, time to Cmax (tmax), time of last non-zero concentration (tlast), area under the plasma concentration versus time curve from the time of dosing to the last measurable concentration (AUClast), and half-life (t½). Values below the LLOQ post-baseline were replaced with a value of 0 ug/mL. Values below the LLOQ at baseline were replaced with zero as it was assumed that subjects had no levels of maribavir at baseline. At the designated timepoints, the PK sample was obtained 2-4 hours after the dose of study drug; for subjects who were inpatients, a pre-dose PK sample also was collected. These samples were not required at Day 8 and Week 4 for subjects who had PK profiles performed on those days.|pre-dose and 1, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 8 and the Week 4 visit|The Pharmacokinetic Profile Population, defined as all participants in the ITT-S Population who had plasma samples drawn and tested for maribavir concentrations||ug/mL||Standard Deviation|Mean
677160|NCT01611974|Secondary|Time to CMV Recurrence|Blood samples were collected at the study sites, processed to plasma aliquots, and sent to the central laboratory for quantitative CMV DNA polymerase chain reaction (PCR) testing. Plasma samples were assayed for CMV concentration using a qualified PCR method. The time to event was defined as the time of the first of at least 2 consecutive samples, separated by at least 5 days, with detectable plasma CMV DNA after achievement of undetectable plasma CMV DNA in at least 2 consecutive samples, separated by at least 5 days, at any time after Day 1; as assessed by the central laboratory. Participants assessed for recurrence (n= 29, 27, 30) are the subset of the ITT-S who had at least 2 consecutive undetectable plasma CMV DNA results separated by at least 5 days, including early withdrawn qualified subjects. The median values are Kaplan-Meier estimates.|36 weeks|The Intent-to-Treat Safety population, defined as all randomized participants who received at least 1 dose of study drug.||days||95% Confidence Interval|Median
677161|NCT01611974|Secondary|Time to First Confirmed Undetectable Plasma CMV DNA Within 6 Weeks and at Any Time During The Study|Blood samples were collected at the study sites, processed to plasma aliquots, and sent to the central laboratory for quantitative CMV DNA polymerase chain reaction (PCR) testing. Plasma samples were assayed for CMV concentration using a qualified PCR method. The time to event was defined as the time from first dose of study drug to first undetectable plasma CMV DNA within 6 weeks and at any time during the study, defined as the date of the first of at least 2 consecutive post-baseline, on-treatment undetectable results (<200 copies/mL) separated by at least 5 days; as assessed by the central laboratory. The median values are Kaplan-Meier estimates.|6 weeks after start of treatment, within 36 weeks of start of treatment|The Intent-to-Treat Safety population, defined as all randomized participants who received at least 1 dose of study drug.||days||95% Confidence Interval|Median
677162|NCT01611974|Secondary|Number of Participants With CMV Recurrence|Blood samples were collected at the study sites, processed to plasma aliquots, and sent to the central laboratory for quantitative CMV DNA polymerase chain reaction (PCR) testing. Plasma samples were assayed for CMV concentration using a qualified PCR method. CMV recurrence was defined as achievement of undetectable plasma CMV DNA at any time after Day 1 in at least 2 consecutive samples separated by at least 5 days, followed by detectable plasma CMV DNA in at least 2 consecutive samples separated by at least 5 days (assessed by the central laboratory). For the analyses of CMV recurrence, the first of 2 consecutive confirmed undetectable plasma CMV DNA results had to be on-treatment. CMV DNA PCR values of ≥200 copies/mL were considered detectable. Participants assessed for recurrence (n= 29, 27, 30) are the subset of the ITT-S who had at least 2 consecutive undetectable plasma CMV DNA results separated by at least 5 days, including early withdrawn qualified subjects.|36 weeks|The Intent-to-Treat Safety population, defined as all randomized participants who received at least 1 dose of study drug.||participants|||Number
677163|NCT01611974|Primary|Number of Participants With a Treatment Emergent Adverse Event (TEAE).|Treatment-emergent adverse events are those events that occurred on or after study drug administration through 7 days after the last dose of study drug, or are events that occurred prior to study drug administration and recurred with increased severity after taking study drug through 7 days after the last dose of study drug.|25 weeks|The Intent-to-Treat Safety population, defined as all randomized participants who received at least 1 dose of study drug.||participants|||Number
677164|NCT01611974|Primary|Number of Participants With Confirmed Undetectable Plasma Cytomegalovirus (CMV) Within 6 Weeks|Blood samples were collected at the study sites, processed to plasma aliquots, and sent to the central laboratory for quantitative CMV DNA polymerase chain reaction (PCR) testing. Plasma samples were assayed for CMV concentration using a qualified PCR method. This method was linear over 200-100,000 viral copies/mL with a lower limit of quantification (LLOQ) of 200 copies/mL. Results below LLOQ were considered undetectable. Confirmed undetectable plasma CMV DNA within 6 weeks was defined as 2 consecutive post-baseline, on-treatment undetectable results separated by >/= 5 days (assessed by the central laboratory). Samples were collected on Days 1 and 8, weekly during Weeks 2-6, and once in Weeks 8, 10, 12, 16, 20, 24 (treatment) and Weeks 1, 4, 8, 12 (follow-up). Permissible assessment windows were: Days 8-15 +/- 1 day; Weeks 3-4 +/- 2 days; Weeks 5-6 +/- 3 days; Weeks 8-12 +/- 4 days; Weeks 16-24 +/- 7 days (treatment) and Weeks 1-4 +/- 2 days; Weeks 8-12 +/- 4 days (follow-up).|6 weeks|The Intent-to-Treat Safety population, defined as all randomized participants who received at least 1 dose of study drug.||participants|||Number
677670|NCT01606228|Secondary|Quality of Sleep at Day 90|The quality of sleep is measured by a self-administered scale in which patients indicate how well they have slept in the previous 7 days, from 0 (very badly) to 100 (very well).|Day 90|Per Protocol (PP) population||scores on a scale||Standard Deviation|Mean
677165|NCT01611948|Primary|Change From Week 0 in Cannabis Use Using Urinary CN-THCCOOH Levels at Week 8|Urinary THC/Cr ratio, also known as CN-THCCOOH (creatinine normalized tetrahydrocannabinol carboxylic acid), is a highly sensitive and specific quantitative analytic procedure to determine current marijuana metabolite levels in the urine as well as new marijuana use or abstinence. Gas chromatography mass spectrometric levels of 11-nor-9-carboxy-9-THC (THC-COOH), the primary marijuana metabolite, are normalized to the urine creatinine (CN) concentration to reduce the variability of drug measurement attributable to urine dilution. Negative values indicate decreased use. Change = (Week 8 value - Week 0 value).|Week 0 and Week 8|Two participants in the matched placebo arm who completed the double blind portion of the trial were unable to be analyzed for change in Urinary CN-THCCOOH Level due to missing data at Week 0 and/or Week 8. One sample was missing source documentation while the other sample was too dilute to return a reliable measurement.||ng/mg||Standard Deviation|Mean
677166|NCT01611883|Secondary|Percent Change in Non–HDL-cholesterol From Baseline|Non-HDL-C levels measured at baseline and after 24 weeks of treatment.|Baseline and Week 24|Full Analysis Set (FAS) defined as all enrolled participants who received at least 1 dose of study drug and baseline and follow-up data available.||Percent Change||95% Confidence Interval|Least Squares Mean
677167|NCT01611883|Secondary|Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline|HDL-C levels measured at baseline and after 24 weeks of treatment.|Baseline and Week 24|Full Analysis Set (FAS) defined as all enrolled participants who received at least 1 dose of study drug and baseline and follow-up data available.||Percent Change||95% Confidence Interval|Least Squares Mean
677168|NCT01611883|Secondary|Percent Change in Triglycerides From Baseline|Triglycerides levels measured at baseline and after 24 weeks of treatment.|Baseline and Week 24|Full Analysis Set (FAS) defined as all enrolled participants who received at least 1 dose of study drug and baseline and follow-up data available.||Percent Change||95% Confidence Interval|Least Squares Mean
677169|NCT01611883|Secondary|Percent Change in Total Cholesterol (TC) From Baseline|TC levels measured at Baseline and after 24 weeks of treatment.|Baseline and Week 24|FAS defined as all enrolled participants who received at least 1 dose of study drug and baseline and follow-up data available.||Percent Change||95% Confidence Interval|Least Squares Mean
677170|NCT01611883|Secondary|Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline|LDL-C levels measured at baseline and after 24 weeks of treatment|Baseline and Week 24|Full Analysis Set (FAS) defined as all enrolled participants who received at least 1 dose of study drug and baseline and follow-up data available.||Percent Change||95% Confidence Interval|Least Squares Mean
677171|NCT01611883|Secondary|Percentage of Participants With Changes in Diabetes Medications Due to Worsening of Diabetes|The percentage of participants who had changes to their medications used to treat their diabetes, other than small changes in insulin dosing (± 5 Units), were reported and summarized.|Up to 24 weeks|AST Population defined as all participants who received at least 1 dose of study drug.||Percentage of Participants|||Number
677172|NCT01611883|Secondary|"Percentage of Participants With Adverse Event (AE) Exacerbation of Diabetes"|The Investigator took into account a participant’s index of blood glucose control, diabetes medications, and compliance to diet and exercise therapy to assess overall control of the participant’s diabetes and to determine if the participant’s diabetes worsened. Participants who experienced the AE “Exacerbation of Diabetes ” (verbatim term) were recorded.|up to 24 weeks|All Subjects Treated (AST) Population defined as all participants who received at least 1 dose of study drug.||Percentage of Participants|||Number
677173|NCT01611883|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline|Plasma glucose levels were assessed after an overnight fast at baseline and after 24 weeks of study drug administration.|Baseline and Week 24|Per Protocol Set defined as all randomized participants meeting inclusion criteria who were not excluded from the Full Analysis Set and were at least 75% compliant with study medication.||mg/dL||95% Confidence Interval|Least Squares Mean
677174|NCT01611883|Secondary|Change in Glycoalbumin From Baseline|Glycoalbumin is a blood marker used to assess blood glucose control over time and is reported as a percentage (%). Serum glycoalbumin levels were assessed at baseline and after 24 weeks of study drug administration.|Baseline and Week 24|Per Protocol Set defined as all randomized participants meeting inclusion criteria who were not excluded from the Full Analysis Set and were at least 75% compliant with study medication.||Percent||95% Confidence Interval|Least Squares Mean
677175|NCT01611883|Primary|Change in Glycated Hemoglobin (HbA1c) From Baseline|HbA1c is blood marker used to report average blood glucose levels over a prolonged period of time and is reported as a percentage (%). HbA1C was measured at baseline and after 24 weeks of study drug administration.|Baseline and Week 24|Per Protocol Set defined as all randomized participants meeting inclusion criteria who were not excluded from the Full Analysis Set and were at least 75% compliant with study medication.||Percent||95% Confidence Interval|Least Squares Mean
677176|NCT01611857|Secondary|Time to Progression in Phase II Dose Expansion|Defined as the time from first treatment until objective tumor progression. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|every 8 weeks until progressive disease, expected 18 months.|The analysis was performed on all participants (N = 34) in the Phase II portion of the study.||months||95% Confidence Interval|Median
677177|NCT01611857|Secondary|Overall Survival in Phase II Dose Expansion|Defined as the time from first treatment until death from any cause.|every 8 weeks until treatment discontinuation, an expected average of 18 months, then every 12 weeks thereafter up to 5 years from start of treatment.|The analysis was performed on an Intent-to-Treat basis (N=34) for all participants in the Phase II portion of the study.||months||95% Confidence Interval|Median
677178|NCT01611857|Secondary|Progression Free Survival in Phase II Dose Expansion|Defined as the time from first treatment until objective tumor progression or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|every 8 weeks until treatment discontinuation, projected 18 months and then every 3 months thereafter up to 5 years from start of treatment.|The analysis was performed on an Intent-to-Treat basis (N = 34) for all participants in the Phase II portion of the study. Median follow-up was 15 months (3-21 months)||months||95% Confidence Interval|Median
677179|NCT01611857|Primary|The Incidence of Dose Limiting Toxicities (DLT) in Phase I Dose Escalation|Using a standard 3+3 design participants were enrolled in dose-escalating cohorts to determine the maximum tolerated dose (MTD) of tivantinib when given with FOLFOX (5-FU 400 mg/m^2, continuous IV 5-FU 2400 mg/m^2 over 46 hours, leucovorin 400 mg/m^2 IV, and oxaliplatin 85 mg/m^2). MTD is defined as the highest dose level at which no more than 1 of 6 patients experiences a DLT, assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.|14 Days (1 cycle)|Patients were assessed for DLT if they received at least 85% of the scheduled doses of study drugs in cycle 1. In the Tivantinib 120 mg cohort two participants were replaced due to missed drug. In the Tivantinib 360 mg cohort one patient was replaced due to an allergic reaction to oxaliplatin.||participants|||Number
677186|NCT01611779|Secondary|Epworth Sleeping Scale (ESS)|0 to 24 (high value represents worse outcome)|Baseline, 1, 3, 12 months|Five (5) of 5 total subjects had data at baseline. Four (4) of 5 subjects had follow-up data at 1 week, 4 had follow-up data at 1 month, 4 had follow-up data at 3 months, and 2 had follow-up data at 12 months.||units on a scale||Standard Deviation|Mean
677187|NCT01611779|Secondary|Snoring Scale (VAS)|0 to 10 (high value represents worse outcome)|Baseline, 1 week; 1 month, 3 months, 12 months|Four (4) of 5 total subjects had data at baseline. Four (4) of 5 subjects had follow-up data at 1 week, 4 had follow-up data at 1 month, 3 had follow-up data at 3 months, and 2 had follow-up data at 12 months.||units on a scale||Standard Deviation|Mean
677188|NCT01611779|Secondary|Functional Outcomes and Sleep Questionnaire (FOSQ)|Questionnaire: 0 to 120 (high value represents better outcome)|Baseline, 1, 3, 12 months|Four (4) of 5 total subjects had data at baseline and follow-up data.||units on a scale||Standard Deviation|Mean
677189|NCT01611779|Secondary|Apnea Hypopnea Index|0 to >30/hour (high value represents worse outcome)|Baseline, 3, and 12 months|Three (3) of 5 subjects returned for 3 month follow-up and 2 of 5 subjects returned for the 12 month follow-up.||events/hour||Standard Deviation|Mean
677190|NCT01611779|Primary|Number of Participants Experiencing Complications|Patient will be examined by the investigator at each of the follow-up visits for the presence of any untoward or unintended response to the device.|3 months|||Participants|||Count of Participants
677191|NCT01611779|Primary|Place the Implant and Stabilize the Tongue|Ability to place the implant and stabilize the tongue|Up to 7 weeks after the procedure|||Participants|||Count of Participants
677192|NCT01611662|Primary|Pathological Complete Response Rate Following Chemotherapy Before Surgery|Pathological response rate following neoadjuvant chemotherapy was assessed by TNM staging at the time of radical cystectomy|Up to 5 years|||percentage of participants||95% Confidence Interval|Number
677193|NCT01611571|Secondary|Change in FN BMD at 18 Months|Change in the Femoral Neck BMD at 18 month|18 months|||% change in TH BMD||Standard Deviation|Mean
677194|NCT01611571|Secondary|New Morphometric Vertebral Fractures|counting the total new morphometric vertebral fractures as determined by x-ray from baseline through end of study|baseline through 18 months|||vertebral fracture|||Number
677195|NCT01611571|Secondary|Change in Forearm Bone Density|change in 1/3 radius of forearm bone density as measured by DXA|baseline and 18 months|||% change in 1/3 Radius BMD||Standard Deviation|Mean
677196|NCT01611571|Secondary|Change in Hip Bone Density|change in hip bone density measured by DXA|baseline and 18 months|||% change in TH BMD||Standard Deviation|Mean
677197|NCT01611571|Primary|Change in Spine Bone Density|change in spine bone density at 18 months measured by DXA 18 and 24 months|18 months|||% change in LS BMD||Standard Deviation|Least Squares Mean
677198|NCT01611558|Secondary|Number of Participants Who Died and With Serious Adverse Events (SAEs), Drug-related SAEs, Drug-related AEs, AEs Leading to Discontinuation, and Drug-related AEs Leading to Discontinuation|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Treatment-related=having certain, probable, possible, or missing relationship to study drug.|From first dose to within 90 days of last study dose|All participants who received at least 1 dose of study drug||Participants|||Number
677199|NCT01611558|Secondary|Best Overall Response Rate (BORR)|BORR is defined as the percentage of participants who received treatment and, at any time during the study, had a best response of complete response or partial response, as confirmed by Response Evaluation Criteria in Solid Tumors (RECIST) or Rustin criteria for patients with cancer antigen 125 (CA125) levels elevated to twice the upper limit of normal at baseline, divided by the total number of evaluable participants in the arm.|From first dose of study drug to unacceptable toxicity or progressive disease (to a maximum of 3 years)|All participants who received study drug. n=number of evaluable participants||Percentage of participants||95% Confidence Interval|Number
677671|NCT01606228|Secondary|Quality of Sleep at Baseline|The quality of sleep is measured by a self-administered scale in which patients indicate how well they have slept in the previous 7 days, from 0 (very badly) to 100 (very well).|Baseline|Per Protocol (PP) population||scores on a scale||Standard Deviation|Mean
677200|NCT01611558|Primary|Number of Participants With Drug-related Adverse Events (AEs) of Grade 3 or Higher|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-threatening or disabling.|Day 1, first dose, to within 90 days of last dose in Induction Phase|All participants who received at least 1 dose of study drug||Participants|||Number
677201|NCT01610791|Primary|Percentage of Participants With Adverse Events|Percentage of participants with adverse events (AEs), serious adverse events (SAEs), severe AEs, AEs leading to withdrawal, AEs leading to death, and treatment-related AEs.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|Safety population: all participants who received at least one dose of study medication where at least one post-baseline assessment of safety was available.||percentage of participants|||Number
677202|NCT01610791|Secondary|Erythrocyte Sedimentation Rate (ESR)|ESR indirectly measures how much inflammation is in the body. A higher ESR is indicative of increased inflammation. The change in ESR was determined as the difference in values from baseline at each visit.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT Population||mm/hr||Standard Deviation|Mean
677203|NCT01610791|Secondary|C-Reactive Protein (CRP)|CRP is an acute phase inflammatory marker. Levels of CRP increase with inflammation. The change in CRP was determined as the difference in values from baseline and at each visit.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT Population||mg/dL||Standard Deviation|Mean
677204|NCT01610791|Secondary|Patient Assessment of of Pain (VAS)|"The participant's assessment of their current level of pain was displayed on a 100-mm horizontal VAS. The left-hand extreme (0 mm) of the line was described as no pain and the right-hand extreme of the line (100 mm) was described as unbearable pain. The change in participant's perception of pain was determined as the difference in values from baseline at each visit."|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT Population||mm||Standard Deviation|Mean
677205|NCT01610791|Secondary|Physician's Global Assessment of Disease Activity (VAS)|"The physician's assessment of the participant's current disease activity was displayed on a 100-mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme (100 mm) was described as maximum disease activity. The Physician's Global Assessment of Disease Activity was completed by the Efficacy Assessor who could or could not be a physician. The change in Physician's Global Assessment of Disease Activity was determined as the difference in values from baseline at each visit."|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT Population||mm||Standard Deviation|Mean
677206|NCT01610791|Secondary|Patient Global Assessment of Disease Activity (VAS)|"The participant's overall assessment of their current disease activity was displayed on a 100-mm horizontal VAS. The left-hand extreme (0 mm) of the line was described as no disease activity (symptom free and no arthritis symptoms) and the right-hand extreme (100 mm) was described as maximum disease activity (maximum arthritis disease activity). The change in Patient Global Assessment of Disease Activity was determined as the difference in values from baseline at each visit."|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT Population||mm||Standard Deviation|Mean
677207|NCT01610791|Secondary|Health Assessment Questionnaire (HAQ)|HAQ was used to assess the physical ability and functional status of participants as well as quality of life. The disability dimension consists of 20 multiple-choice items concerning difficulty in performing 8 common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Participants choose from 4 response categories, ranging from 'without any difficulty' (Score=0) to 'unable to do' (Score=3). The change in HAQ was determined as the difference in values from baseline at each visit.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT Population||score on a scale||Standard Deviation|Mean
677208|NCT01610791|Secondary|Swollen and Tender Joint Counts|The following 28 joints were assessed by the physician for swelling: metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2). The following 28 joints were assessed by the physician for tenderness : metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2). The change in SJC and TJC was determined as the difference in values from baseline at each visit.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT Population||joints||Standard Deviation|Mean
677209|NCT01610791|Secondary|Percentage of Participants With a Response Assessed Using American College of Rheumatology (ACR) Criteria|The ACR response rates ACR20, ACR50, ACR70 are defined as ≥20%, ≥50%, ≥70% improvement, respectively, in: swollen joint count (SJC) (66 joints) and tender joint count (TJC) (68 joints) and 3 of the following 5 assessments: Patient assessment of pain (VAS); Patient global assessment of disease activity (VAS); Investigator global assessment of disease activity (VAS); and acute phase response (ESR or CRP)|Weeks 4, 8, 12, 16, 20, and 24|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
677210|NCT01610791|Secondary|Percentage of Participants Achieving Remission (DAS28 <2.6)|DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hour) and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. Participants with a DAS28 score <2.6 were considered to have achieved remission.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
677211|NCT01610791|Secondary|Time to Achieve Clinically Meaningful Reduction in DAS28|A clinically meaningful improvement in DAS28 was defined as a reduction of at least 1.2 units. Time to achieving clinically meanigful improvement was calculated as the number of days from the first infusion to the first achievement of reduction of 1.2 units in DAS28.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT Population||days||Standard Deviation|Mean
677212|NCT01610791|Secondary|Percentage of Participants With a Clinically Meaningful Improvement in Disease Activity|DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hour) and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. A reduction in DAS28 of at least 1.2 units was considered a clinically meaningful improvement.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT Population||percentage of participants|||Number
677213|NCT01610791|Secondary|Percentage of Participants by DAS28 Response Category|DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hour) and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. DAS28 ≤3.2 =low disease activity, DAS28 >3.2 to ≤5.1=moderate to high disease activity; DAS28 >5.1=high disease activity.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
677214|NCT01610791|Secondary|Disease Activity Score Based on 28-Joint Count (DAS28)|DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate (ESR; in millimeters per hour [mm/hour]) and global health assessment (participant-rated global assessment of disease activity using 10-mm visual analog assessment [VAS]); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. DAS28 less than or equal to (≤3.2) = low disease activity, DAS28 greater than (>)3.2 to less than or equal to (≤) 5.1=moderate to high disease activity; DAS28 >5.1=high disease activity.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||units on a scale||Standard Deviation|Mean
677215|NCT01610791|Secondary|Percentage of Participants With Lipid Elevations by Study Visit|Lipid panel assessed included TC, triglycerides, high-density lipoprotein (HDL), and LDL. Elevations were categorized as follows: LDL cholesterol: Optimal equals (=) less than (<)100 mg/dL, Near optimal=100-129 mg/dL, Borderline high 130-159 mg/dL, High 160-189 mg/dL, Very High ≥190 mg/dL; Total cholesterol: Desirable <200 mg/dL, Borderline high 200-239 mg/dL, High ≥240 mg/dL; HDL cholesterol: Low <40 mg/dL, High ≥60 mg/dL; Triglycerides: Normal <150 mg/dL, Borderline high 150-199 mg/dL, High 200-499 mg/dL, and Very high ≥500 mg/dL.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|Safety population; n (number) = number of participants assessed for the parameter at a given visit.||percentage of participants|||Number
677216|NCT01610791|Secondary|Change From Baseline Low-Density Lipoprotein (LDL) and Total Cholesterol (TC) to Highest Values|Levels of LDL and TC were measured in milligrams/deciliter (mg/dL). Change in LDL and TC were calculated as the value (highest) through Week 24, minus the value at Baseline.|Baseline through Week 24|Safety population||mg/dL||Standard Deviation|Mean
677217|NCT01610791|Secondary|Change From Baseline in Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) to Highest Value|The difference between baseline and highest values until Week 24 of ALT and AST. The values are measures as international units per liter (UI/L). The change was calculated as the value (highest) at a later timepoint up to Week 24, minus the value at Baseline.|Baseline through Week 24|Safety Population||UI/L||Standard Deviation|Mean
677218|NCT01610791|Secondary|Percentage of Participants With All-Cause Discontinuation of Tocilizumab by Study Visit|Percentage of participants discontinuing study treatment for any reason at every visit; causes of discontinuation in the summary included AEs, deaths, lost to follo-wup, AE and investigator decision and 'not determined'.|Weeks 4, 8, 12, 16, 20, and 24|All enrolled participants were included in the analysis||percentage of participants|||Number
677219|NCT01610713|Secondary|Subject Global Opinion of Effect on Multiple Sclerosis at the End of Open-label Treatment|A 7-point Likert-type scale was used, with the question: ‘Please assess the status of your multiple sclerosis since entry into the study using the scale below’ with the markers “very much improved, much improved, slightly improved, no change, slightly worse, much worse or very much worse”. The number of subjects that considered their condition to be better or much better at the end of open-label treatment is presented.|End of Part B (week 10)|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.||participants|||Number
677220|NCT01610713|Secondary|Change From Part A Mean Ten-metre Mobility Score at the End of Open-Label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The 10 Metre Mobility Score is a four point scale assessing a subject’s level of mobility. The time taken to walk ten metres was measured for the subset of subjects who were able to walk. A decrease in time indicates and improvement.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.||time (seconds)||Standard Deviation|Mean
677221|NCT01610713|Secondary|Change From Part A Mean Bladder Problems Visual Analogue Scale Score at the End of Open-Label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. Severity scores over the last 24 hours were recorded using a 100 mm Visual Analogue Scale on one nominated day each week. Scores ranged from 0 = no problem to 100 = very bad. A decrease in score indicates an improvement. As such, a negative value indicates an improvement in bladder problems from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.||units on a scale||Standard Deviation|Mean
677222|NCT01610713|Secondary|Change From Part A Mean Tremor Visual Analogue Scale Score at the End of Open-Label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. Severity scores over the last 24 hours were recorded using a 100 mm Visual Analogue Scale on one nominated day each week. Scores ranged from 0 = no problem to 100 = very bad. A decrease in score indicates an improvement. As such, a negative value indicates an improvement in tremor from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.||units on a scale||Standard Deviation|Mean
677265|NCT01610700|Secondary|Change From Baseline in Tremor Visual Analogue Scale Score at the End of 6 Weeks of Treatment|Severity scores were recorded using a 100 mm Visual Analogue Scale. Scores ranged from 0 = no problem to 100 = very bad. A decrease in score indicates an improvement.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.||units on a scale||Standard Deviation|Mean
677949|NCT01603420|Secondary|Assessment of Impotence by Summation of Relative Scores for Sexual Function From the EPIC Quality of Life Instrument.|unable to assess due to lack of data|Up to 10 years|unable to assess due to study termination|||||
677223|NCT01610713|Secondary|Change From Part A Mean Muscle Spasm Visual Analogue Scale Score at the End of Open-Label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. Severity scores over the last 24 hours were recorded using a 100 mm Visual Analogue Scale on one nominated day each week. Scores ranged from 0 = no problem to 100 = very bad. A decrease in score indicates an improvement. As such, a negative value indicates and improvement in spasms from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.||units on a scale||Standard Deviation|Mean
677224|NCT01610713|Secondary|Change From Part A Mean Pain Visual Analogue Scale Score at the End of Open-Label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. Severity scores over the last 24 hours were recorded using a 100 mm Visual Analogue Scale on one nominated day each week. Scores ranged from 0 = no problem to 100 = very bad. A decrease in score indicates an improvement. As such, a negative value indicates an improvement in pain from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.||units on a scale||Standard Deviation|Mean
677225|NCT01610713|Secondary|Change From Part A Mean Spasticity Visual Analogue Scale Score at the End of Open-Label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. Severity scores over the last 24 hours were recorded using a 100 mm Visual Analogue Scale on one nominated day each week. Scores ranged from 0 = no problem to 100 = very bad. A decrease in score indicates an improvement, as such a negative value indicates an imrovement in condition from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.||units on a scale||Standard Deviation|Mean
677226|NCT01610713|Secondary|Change From Part A Mean Feeling Upon Wakening 100 mm Visual Analogue Scale Score at the End of Open-Label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. Feeling upon wakening was rated using a 100 mm visual analogue scale where 0 = best and 100 = worst. As such, a negative value is indicative of an improvement in score from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.||units on a scale||Standard Deviation|Mean
677227|NCT01610713|Secondary|Change From Part A Mean Sleep Amount 100 mm Visual Analogue Scale Score at the End of Open-label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. Sleep amount was rated using a 100 mm visual analogue scale where 0 = best and 100 = worst. As such, a negative value is indicative of an improvement in score from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.||units on a scale||Standard Deviation|Mean
677228|NCT01610713|Secondary|Incidence of Adverse Events as a Measure of Patient Safety|The number of patients who recorded an adverse event during the 4 week open-label period is presented.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|This analyses set included all patients who took GW-1000-02 during the open-label treatment period.||participants|||Number
677229|NCT01610713|Secondary|Change From Mean Part A Sleep Quality 100 mm Visual Analogue Scale Score at the End of Open-label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. Sleep quality scores were rated using a 100 mm visual analogue scale where 0 = best and 100 = worst. As such, a negative value is indicative of an improvement in score from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.||units on a scale||Standard Deviation|Mean
677230|NCT01610713|Secondary|Change From Mean Part A Tremor Activities of Daily Living Score at the End of Open-label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The tremor activities of daily living scale is a patient self-reported questionnaire which consists of 25 questions relating to the effect of tremors on different day-to-day activities, such as eating, drinking, threading a needle and tying a shoe. The ability to perform these tasks was scored on a scale of 0 (unable) to 3 (completely able). The summary parameter was the total score with a minimum of 0 (unable to perform tasks) and a maximum of 75 (completely able to perform tasks). As such, a positive value indicates an improvement in condition from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.||units on a scale||Standard Deviation|Mean
677231|NCT01610713|Secondary|Change From Mean Part A Total Bladder Control Questionnaire Score at the End of Open-label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The total bladder control test score was the sum score from fifteen questions, which were each scored on a 0-2 scale (one question 0-3), where 0 = good and 2/3 = bad. Ten questions were related to bladder symptoms and control and five were related to the effects on the patient's life. The summary parameters were the total score with a minumum possible score of 0 and a maximum possible score of 31. A decrease in score indicates an improvement, as such a negative value indicates an improvement in condition from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.||units on a scale||Standard Deviation|Mean
677950|NCT01603420|Secondary|Assessment of Total Number of Local/Distant Failures|The total number of local/distant failures will be assessed.|at time of study closure (22 months)|||participants|||Number
677232|NCT01610713|Secondary|Change From Mean Part A Nine Hole Peg Test Score at the End of Open-label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The Nine-Hole Peg Test is a board with nine holes into which subjects have to insert nine pegs and is designed to test dexterity and coordination. Scores range from 0 (good) to 60 (bad). As such a decrease in score indicates an improvement, and a negative value indicates an improvement from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.||units on a scale||Standard Deviation|Mean
677233|NCT01610713|Secondary|Change From Mean Part A Total 28-item General Health Questionnaire Score at the End of Open-label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The 28-item General Health Questionnaire is a self-reported questionnaire for the detection of non-psychotic mental disorders (anxiety and depression) in the community and primary care settings. A series of four subscale scores (ranging from 0 [good] to 21 [bad]) were combined to give a total score, which ranged from 0 (good) to 84 (bad). As such, a negative value indicates an improvement in score from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.||units on a scale||Standard Deviation|Mean
677234|NCT01610713|Secondary|Change From Mean Part A Rivermead Mobility Index Score at the End of Open-label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The Rivermead Mobility Index is a measure of subject self-mobilisation and was developed to enable rehabilitation professionals to document the effect(s) of interventions. This consisted of 15 questions relating to the dexterity and/or mobility of the patient. Each question had a 'yes' / 'no' answer which was scored as yes=1 no=0. The summary parameter was the total for the 15 questions, with a maximum score of 15. An increased score indicates improvement. As such, a positive value indicates an improvement in score from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.||units on a scale||Standard Deviation|Mean
677235|NCT01610713|Secondary|Change From Mean Part A Fatigue Severity Scale Questionnaire Score at the End of Open-label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The Fatigue Severity Scale is a nine-item questionnaire developed to assess the level of fatigue due to neurological disease, were each assessed on a 0-6 scale (0= no fatigue and 6= severe fatigue). As such a decreased score indicates improvement, and a negative value indicates and improvement from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.||units on a scale||Standard Deviation|Mean
677236|NCT01610713|Secondary|Change From Mean Part A Beck's Depression Inventory (BDI-II) Score at the End of Open-label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The BDI-II was a 21-question multiple choice self-reported inventory. Subjects' responses to the 21 questions were assigned a score ranging from zero (good) to three (bad), indicating the severity of the symptom. The sum of all BDI-II question scores indicated the severity of depression; score range 0-63. A decrease in score indicates an improvement in condition. As such, a negative value indicates in improvement in score from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.||units on a scale||Standard Deviation|Mean
677237|NCT01610713|Secondary|Change From Mean Part A Total Adult Memory and Information Processing Battery Score at the End of Open-label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The Adult Memory and Information Processing Battery test comprises six sub-sections which assess cognition and mental alertness. These include immediate and delayed story recall, word-list learning, copying a complex figure followed by its immediate reproduction, design learning, and information processing (parts A and B). The sum score for each section gave the total score which ranged from 1 (bad) to 105 (good). As such, a positive value indicates an improvement in score from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.||units on a scale||Standard Deviation|Mean
677238|NCT01610713|Secondary|Change From Mean Part A Barthel Activities for Daily Living Score at the End of Open-label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The Barthel Index consists of 10 items that measure a person's daily functioning, specifically the activities of daily living and mobility. The items include feeding, moving from wheelchair to bed and return, grooming, transferring to and from a toilet, bathing, walking on level surface, going up and down stairs, dressing, continence of bowels and bladder. The ability to undertake the different daily activities was assessed on scales of 0-1 to 3, with 0= poorest outcome and upper scores= best outcome. The total score was the sum of scores for each item; minimum score= 0, maximum score= 20. A change of two or greater in the total score indicating a clinically relevant change. A positive value indicates an improvement in score from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.||units on a scale||Standard Deviation|Mean
677266|NCT01610700|Secondary|Change From Baseline in Muscle Spasm Visual Analogue Scale Score at the End of 6 Weeks of Treatment|Severity scores were recorded using a 100 mm Visual Analogue Scale. Scores ranged from 0 = no problem to 100 = very bad. A decrease in score indicates an improvement.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.||units on a scale||Standard Deviation|Mean
677239|NCT01610713|Secondary|Change From Mean Part A Short Orientation Memory Concentration Score at the End of Open-label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The Short Orientation-Memory-Concentration test is a questionnaire designed to measure orientation, concentration on simple tasks and learning and recall of simple information. The test consists of six items, such as 'what year is it now?' and 'count backwards from 20 to 1'. Each item was scored between 0 (maximum number of errors) and three-10 (best score; no errors), with a point deducted for each error. The summary parameter was the total score from the sum of scores for each item, with an overall possible maximum score of 28 (no errors). Scores over 20 are considered ‘normal’. As such, an increased score indicates an improvement, and a positive value indicates an improvement in score from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.||units on a scale||Standard Deviation|Mean
677240|NCT01610713|Secondary|Change From Mean Part A Ashworth Scale Score at the End of Open-label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. All 20 muscle groups were assessed for spasticity (using a 1-5 scale): 1= no increase in muscle tone to 5= passive movement is difficult and affected part is rigid in flexion or extension. The score for all 20 muscle groups were added to give a total score out of 100; minimum score was 20. A decrease in score indicates an improvement in condition. As such, a negative value indicates an improvement in score from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.||units on a scale||Standard Deviation|Mean
677241|NCT01610713|Secondary|Change From Mean Part A Reading Visual Acuity Test Score at the End of Open-label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. Assessment of reading visual acuity was made using a standard reading chart. Scores could range from 1 (good) to 20 (bad), indicating good and poor eyesight, respectively. As such, a negative value from baseline indicates an improvement in eyesight.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.||units on a scale||Standard Deviation|Mean
677242|NCT01610713|Secondary|Change From Mean Part A Care-Giver Strain Index Score at the End of Open-label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The Caregiver Strain Index is a 13-item questionnaire designed to detect strain in those that care for subjects. Carers were asked if they found certain situations difficult (i.e. work adjustments, family adjustment, emotional adjustments, physical effort). Each question was scored zero (answered no) or one (answered yes), and was recorded for each of the 13 questions. The summary parameter was the total score, which was the sum score of the 13 questions, giving a minimum possible score of 0 (no strain) and maximum possible score of 13 (maximum possible strain). As such a negative value from baseline indicates an improvement in caregiver strain.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.||units on a scale||Standard Deviation|Mean
677243|NCT01610713|Secondary|Change From Mean Part A Guy's Neurological Disability Scale Score at the End of Open-label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The Guy's Neurological Disability Scale has 12 separate categories which include cognition, mood, vision, speech, swallowing, upper limb function, lower limb function, bladder function, bowel function, sexual function, fatigue, and 'others'. Each category consists of a series of questions, which are scored on a 0 to 5 scale, with 0 being indicative of a better outcome and 5 being indicative of a worse outcome. The total Guy’s Neurological Disability Scale score is the unweighted sum from the 12 categories with a minimum score of 0 and maximum of 60. A negative value indicates an improvement in score from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.||units on a scale||Standard Deviation|Mean
677244|NCT01610713|Primary|Change From Mean Part A Primary Impairment Visual Analogue Scale Score (After 6 Weeks) at the End of Four Weeks of Open-label Treatment (10 Weeks Total)|This was achieved by measuring the change in the Part A study score (mean of all scores during the last two weeks of six weeks of double-blind therapy) in the severity of the primary impairment (mean of all scores during the last two weeks of four weeks of open-label therapy), a composite score from one of five multiple sclerosis symptom categories that subjects nominated as their most severe symptom. The severity scores were recorded using a 100 mm Visual Analogue Scale, where 0 = no problem and 100 = very bad. As such, a decrease in score indicates an improvement and a negative value indicates an improvement in score from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.||units on a scale||Standard Deviation|Mean
677245|NCT01610700|Secondary|Change From Baseline in the Mean Total Adult Memory and Information Processing Battery Test Score at the End of Treatment|The Adult Memory and Information Processing Battery test comprises six sub-sections which assess cognition and mental alertness. These include immediate and delayed story recall, word-list learning, copying a complex figure followed by its immediate reproduction, design learning, and information processing (parts A and B). The sum score for each section gave the total score which ranged from 1 (bad) to 105 (good). As such, a positive value indicates an improvement in score from baseline.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.||units on a scale||Standard Deviation|Mean
677672|NCT01606228|Secondary|Patient Satisfaction With Paliperidone Treatment|Patients will be interviewed to assess their satisfaction with the current treatment on a 5-point scale (very good, good, reasonable, moderate or poor).|90 days|Per Protocol (PP) population||participants|||Number
677246|NCT01610700|Secondary|Change From Baseline in the Mean Guy's Neurological Disability Scale Score at the End of Treatment|The Guy's Neurological Disability Scale has 12 separate categories which include cognition, mood, vision, speech, swallowing, upper limb function, lower limb function, bladder function, bowel function, sexual function, fatigue, and 'others'. Each category consists of a series of questions, which are scored on a 0 to 5 scale, with 0 being indicative of a better outcome and 5 being indicative of a worse outcome. The total Guy’s Neurological Disability Scale score is the unweighted sum from the 12 categories with a minimum score of 0 and maximum of 60. A negative value indicates an improvement in score from baseline.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.||units on a scale||Standard Deviation|Mean
677247|NCT01610700|Secondary|Change From Baseline in the Mean Care-Giver Strain Index Score at the End of Treatment|The Caregiver Strain Index is a 13-item questionnaire designed to detect strain in those that care for subjects. Carers were asked if they found certain situations difficult (i.e. work adjustments, family adjustment, emotional adjustments, physical effort). Each question was scored zero (answered no) or one (answered yes), and was recorded for each of the 13 questions. The summary parameter was the total score, which was the sum score of the 13 questions, giving a minimum possible score of 0 (no strain) and maximum possible score of 13 (maximum possible strain). As such a negative value from baseline indicates an improvement in caregiver strain.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.||units on a scale||Standard Deviation|Mean
677248|NCT01610700|Secondary|Change From Baseline in the Mean Reading Visual Acuity Test Score at the End of Treatment|Assessment of reading visual acuity was made using a standard reading chart. Scores could range from 1 (good) to 20 (bad), indicating good and poor eyesight, respectively. As such, a negative value from baseline indicates an improvement in eyesight.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.||units on a scale||Standard Deviation|Mean
677249|NCT01610700|Secondary|Change From Baseline in the Mean Short Orientation-Memory-Concentration Test at the End of Treatment|The Short Orientation-Memory-Concentration test is a questionnaire designed to measure orientation, concentration on simple tasks and learning and recall of simple information. The test consists of six items, such as 'what year is it now?' and 'count backwards from 20 to 1'. Each item was scored between 0 (maximum number of errors) and three-10 (best score; no errors), with a point deducted for each error. The summary parameter was the total score from the sum of scores for each item, with an overall possible maximum score of 28 (no errors). Scores over 20 are considered ‘normal’. As such, an increased score indicates an improvement, and a positive value indicates an improvement in score from baseline.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.||units on a scale||Standard Deviation|Mean
677250|NCT01610700|Secondary|Change From Baseline in the Mean Barthel Activities for Daily Living Scale Score at the End of Treatment|The Barthel Index consists of 10 items that measure a person's daily functioning, specifically the activities of daily living and mobility. The items include feeding, moving from wheelchair to bed and return, grooming, transferring to and from a toilet, bathing, walking on level surface, going up and down stairs, dressing, continence of bowels and bladder. The person receives a score based on whether they have received help while doing the task. The ability to undertake the 10 different daily activities was assessed on scales of 0-1, 0-2 or 0-3, with 0 indicative of the poorest outcome and the highest possible score indicative of the best outcome. The summary parameter was the total score for each of the ten items, with a minimum possible score of 0 and a maximum possible score of 20. An increased score indicates an improvement, with a change of two or greater in the total score indicating a clinically relevant change. A positive value therefore indicates an improvement from baseline.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.||units on a scale||Standard Deviation|Mean
677251|NCT01610700|Secondary|Change From Baseline in the Mean Feeling Upon Wakening 100 mm Visual Analogue Scale Score at the End of Treatment|Sleep amount was rated using a 100 mm visual analogue scale where 0 = best and 100 = worst. As such, a negative value is indicative of an improvement in score from baseline.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.||units on a scale||Standard Deviation|Mean
677252|NCT01610700|Secondary|Change From Baseline in the Mean Sleep Amount 100 mm Visual Analogue Scale Score at the End of Treatment|Sleep amount was rated using a 100 mm visual analogue scale where 0 = best and 100 = worst. As such, a negative value is indicative of an improvement in score from baseline.|Baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.||units on a scale||Standard Deviation|Mean
677253|NCT01610700|Secondary|Change From Baseline in the Mean Sleep Quality 100 mm Visual Analogue Scale Score at the End of Treatment|Sleep quality scores were rated using a 100 mm visual analogue scale where 0 = best and 100 = worst. As such, a negative value is indicative of an improvement in score from baseline.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.||units on a scale||Standard Deviation|Mean
677254|NCT01610700|Secondary|Change From Baseline in the Mean Ten-metre Mobility Score at the End of Treatment|The 10 Metre Mobility Score is a four point scale assessing a subject’s level of mobility. The time taken to walk ten metres was measured for the subset of subjects who were able to walk. A decrease in time indicates an improvement in condition.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.||time (seconds)||Standard Deviation|Mean
677267|NCT01610700|Secondary|Change From Baseline in Pain Visual Analogue Scale Score at the End of 6 Weeks of Treatment|Severity scores were recorded using a 100 mm Visual Analogue Scale. Scores ranged from 0 = no problem to 100 = very bad. A decrease in score indicates an improvement.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.||units on a scale||Standard Deviation|Mean
677255|NCT01610700|Secondary|Change From Baseline in the Mean Tremor Activities of Daily Living Scale Score at the End of Treatment|The tremor activities of daily living scale is a patient self-reported questionnaire which consists of 25 questions relating to the effect of tremors on different day-to-day activities, such as eating, drinking, threading a needle and tying a shoe. The ability to perform these tasks was scored on a scale of 0 (unable) to 3 (completely able). The summary parameter was the total score with a minimum of 0 (unable to perform tasks) and a maximum of 75 (completely able to perform tasks). As such, a positive value indicates an improvement in condition from baseline.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.||units on a scale||Standard Deviation|Mean
677256|NCT01610700|Secondary|Change From Baseline in the Mean Total Bladder Control Test Score at the End of Treatment|The total bladder control test score was the sum score from fifteen questions were each scored on a 0-2 scale (one question 0-3), where 0 = good and 2/3 = bad. Ten questions were related to bladder symptoms and control and five were related to the effects on the patient’s life. The summary parameters were the total score with a minumum possible score of 0 and a maximum possible score of 31. A decrease in score indicates an improvement, as such a negative value indicates an improvement in condition from baseline.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.||units on a scale||Standard Deviation|Mean
677257|NCT01610700|Secondary|Change From Baseline in the Mean Nine-hole Peg Test Score at the End of Treatment|The Nine-Hole Peg Test is a board with nine holes into which subjects have to insert nine pegs and is designed to test dexterity and coordination. Scores range from 0 (good) to 60 (bad). As such a decrease in score indicates an improvement, and a negative value indicates an improvement from baseline.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.||units on a scale||Standard Deviation|Mean
677258|NCT01610700|Secondary|Change From Baseline in the Mean Total 28-item General Health Questionnaire Score at the End of Treatment|The 28-item General Health Questionnaire is a self-reported questionnaire for the detection of non-psychotic mental disorders (anxiety and depression) in the community and primary care settings. A series of four subscale scores (ranging from 0 [good] to 21 [bad]) were combined to give a total score, which ranged from 0 (good) to 84 (bad). As such, a negative value indicates an improvement in score from baseline.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.||units on a scale||Standard Deviation|Mean
677259|NCT01610700|Secondary|Change From Baseline in the Mean Rivermead Mobility Index Score at the End of Treatment|The Rivermead Mobility Index is a measure of subject self-mobilisation and was developed to enable rehabilitation professionals to document the effect(s) of interventions. This consisted of 15 questions relating to the dexterity and/or mobility of the patient. Each question had a ‘yes’ / ‘no’ answer which was scored as yes=1 no=0. The summary parameter was the total for the 15 questions, with a maximum score of 15. An increased score indicates improvement. As such, a positive value indicates an improvement in score from baseline.|Baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.||units on a scale||Standard Deviation|Mean
677260|NCT01610700|Secondary|Change From Baseline in the Mean Fatigue Severity Scale Questionnaire Score at the End of Treatment|The Fatigue Severity Scale is a nine-item questionnaire developed to assess the level of fatigue due to neurological disease, were each assessed on a 0-6 scale (0= no fatigue and 6= severe fatigue). As such a decreased score indicates improvement, and a negative value indicates and improvement from baseline.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.||units on a scale||Standard Deviation|Mean
677261|NCT01610700|Secondary|Change From Baseline in the Mean Beck's Depression Inventory (BDI-II) Score at the End of Treatment|This was a 21-question multiple choice self-report inventory. Subjects’ responses to the 21 questions were assigned a score ranging from zero (good) to three (bad), indicating the severity of the symptom. The sum of all BDI-II question scores indicated the severity of depression; score range 0-63. A decrease in score indicates an improvement in condition. As such, a negative value indicates in improvement in score from baseline.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.||units on a scale||Standard Deviation|Mean
677262|NCT01610700|Secondary|Change From Baseline in Modified Ashworth Scale Score at the End of Treatment|All 20 muscle groups were assessed for spasticity (using a 1-5 scale): 1= no increase in muscle tone to 5= passive movement is difficult and affected part is rigid in flexion or extension. The score for all 20 muscle groups were added to give a total score out of 100; minimum score was 20. A decrease in score indicates an improvement in condition. As such, a negative value indicates an improvement in score from baseline.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.||units on a scale||Standard Deviation|Mean
677263|NCT01610700|Secondary|Subject Global Opinion of Effect on Multiple Sclerosis at the End of Treatment|A 7-point Likert-type scale was used, with the question: ‘Please assess the status of your multiple sclerosis since entry into the study using the scale below’ with the markers “very much improved, much improved, slightly improved, no change, slightly worse, much worse or very much worse”. At Visit 2 (Baseline) patients wrote a brief description of their Multiple sclerosis which was used at end of treatment to aid their memory regarding their symptoms at study start. The number of subjects that considered their condition to be better or much better at the end of treatment is presented.|6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.||participants|||Number
677264|NCT01610700|Secondary|Change From Baseline in Bladder Problems Visual Analogue Scale Score at the End of 6 Weeks of Treatment|Severity scores were recorded using a 100 mm Visual Analogue Scale. Scores ranged from 0 = no problem to 100 = very bad. A decrease in score indicates an improvement.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.||units on a scale||Standard Deviation|Mean
677268|NCT01610700|Secondary|Change From Baseline in Spasticity Visual Analogue Scale Score at the End of 6 Weeks of Treatment|Severity scores over the last 24 hours were recorded using a 100 mm Visual Analogue Scale on one nominated day each week. Scores ranged from 0 = no problem to 100 = very bad. A decrease in score indicates an improvement.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.||units on a scale||Standard Deviation|Mean
677269|NCT01610700|Primary|Change From Baseline in Composite Primary Impairment Visual Analogue Scale Score at the End of 6 Weeks of Treatment|This was achieved by measuring the change from baseline after six weeks of therapy in the severity of the primary impairment, a composite score from one of five Multiple Sclerosis symptom categories that subjects nominated as their most severe symptom. The severity scores were recorded using a 100 mm Visual Analogue Scale, where 0 = no problem and 100 = very bad. A decrease in score indicates an improvement.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.||units on a scale||Standard Deviation|Mean
677270|NCT01610687|Secondary|Change From Baseline in the Mean Bladder Problems 100 mm Visual Analogue Scale Score at Week 18|A clinical assessment of bladder problems was made at each study visit using a 100 mm Visual Analogue Scale, where 0 = no bladder problems and 100 = worst possible bladder problems. A decrease in score indicates an improvement.|18 weeks|All subjects who took at least one dose of study medication after the end of the Part B open-label phase of the acute study, and yielded on-treatment efficacy data was classed as the efficacy and safety population.||units on a scale||Standard Deviation|Mean
677271|NCT01610687|Secondary|Change From Baseline in the Mean Tremor 100 mm Visual Analogue Scale Score at Week 18|A clinical assessment of tremor was made at each study visit using a 100 mm Visual Analogue Scale, where 0 = no tremor and 100 = worst possible tremor. A decrease in score indicates an improvement.|week 18|All subjects who took at least one dose of study medication after the end of the Part B open-label phase of the acute study, and yielded on-treatment efficacy data was classed as the efficacy and safety population.||units on a scale||Standard Deviation|Mean
677272|NCT01610687|Secondary|Change From Baseline in the Mean Spasticity 100 mm Visual Analogue Scale Score at Week 18|A clinical assessment of spasticity was made at each study visit using a 100 mm Visual Analogue Scale, where 0 = no spasticity and 100 = worst possible spasticity. A decrease in score indicates an improvement.|week 18|All subjects who took at least one dose of study medication after the end of the Part B open-label phase of the acute study, and yielded on-treatment efficacy data was classed as the efficacy and safety population.||units on a scale||Standard Deviation|Mean
677273|NCT01610687|Secondary|Change From Baseline in the Mean Pain 100 mm Visual Analogue Scale Score at Week 18|A clinical assessment of pain was made at each study visit using a 100 mm Visual Analogue Scale, where 0 = no pain and 100 = worst possible pain. A decrease in score indicates an improvement.|week 18|All subjects who took at least one dose of study medication after the end of the Part B open-label phase of the acute study, and yielded on-treatment efficacy data was classed as the efficacy and safety population.||units on a scale||Standard Deviation|Mean
677274|NCT01610687|Secondary|Investigator Assessed Global Severity Score at Week 18|The investigator rated the global severity of the subject's primary condition since entry into the study using a five-point verbal rating scale-5: 1=much worse, 2=worse, 3=no change, 4=better, 5=much better. The number of patients which were considered better or much better (scores 4 and 5) at week 18 of the study better is presented.|week 18|All subjects who took at least one dose of study medication after the end of the Part B open-label phase of the acute study, and yielded on-treatment efficacy data was classed as the efficacy and safety population.||participants|||Number
677275|NCT01610687|Secondary|Change From Baseline in Mean Intoxication 100 mm Visual Analogue Scale Scores at Week 18.|Intoxication levels were recorded on a Visual Analogue Scale, where 0 equals 'no intoxication' and 10 equals 'extreme intoxication'. A decrease in score indicates an improvement in intoxication levels.|18 weeks|All subjects who took at least one dose of study medication after the end of the Part B open-label phase of the acute study, and yielded on-treatment efficacy data was classed as the efficacy and safety population.||units on a scale||Standard Deviation|Mean
677276|NCT01610687|Secondary|Mean Number of Sprays of Study Medication Taken During the Last 6 Days of Treatment|A categorical summary was produced of the mean number of sprays per day during the last six days of treatment, and the mean number of sprays was rounded to the nearest whole number for categorisation.|up to 1206 days|All subjects who took at least one dose of study medication after the end of the Part B open-label phase of the acute study, and yielded on-treatment efficacy data was classed as the efficacy and safety population.||sprays of study medication||Standard Deviation|Mean
677277|NCT01610687|Primary|Incidence of Adverse Events as a Measure of Patient Safety|The number of patients who experienced an adverse event during the course of this extension study is presented|up to1206 days|All subjects who took at least one dose of study medication after the end of the Part B open-label phase of the acute study, and yielded on-treatment efficacy data was classed as the efficacy and safety population.||participants|||Number
677278|NCT01610596|Secondary|Overall Disease Severity Score (Improvement)|"The proportion of subjects rated a improved for ODS at Day 8 and Day 15. Improvement is defined as at least a two (2) grade decrease in severity score relative to baseline using a five-point scale ranging from 0 = clear to 4 = severe/very severe."|Days 8 and 15|||percentage of participants|||Number
677279|NCT01610596|Secondary|Clinical Signs and Symptoms of Psoriasis|"The proportion of subjects rated a treatment success for each of the clinical signs and symptoms of psoriasis: scaling, erythema, plaque elevation and pruritis. Treatment success is defined as a score of 0 or 1 on a five-point scale ranging from 0 = clear to 4 = severe/very severe."|Days 8 and 15|Analysis shown is based on the ITT population.||percentage of participants|||Number
677280|NCT01610596|Secondary|Percent Body Surface Area|Changes in percent BSA with active psoriasis in the Treatment Area|Baseline, Days 8 and 15|Analysis shown is based on the ITT population.||Change in %BSA||Standard Deviation|Mean
677281|NCT01610596|Primary|Overall Disease Severity Score (Success)|"Overall disease severity (ODS) will be recorded at baseline, Day 8, and Day 15 on a 0 (clear) to 4 (severe/very severe) point scale. The primary efficacy endpoint was the percentage of subjects with ODS treatment success at end of treatment (Day 15). Success was defined as a grade of 0 or 1 on the ODS scale."|Day 15|Analysis shown is the Intent-to-treat (ITT) population, defined as all enrolled participants who were randomized and applied at least one dose of the test article.||percentage of participants|||Number
677282|NCT01610570|Other Pre-specified|Number of Participants With Dose Limiting Toxicity (DLT)|Hematologic DLT was defined as any grade 4 neutropenia (<500/µL) or thrombocytopenia (<25,000/µL) refractory to platelet transfusion, any grade 2 bleeding not promptly (within 6 h of appropriate intervention) corrected with blood product support. Non-hematologic DLT's were any mithramycin-related grade ≥3 toxicity with the exception of grade 3 nausea, vomiting, or diarrhea that was controlled by symptomatic treatment within 72h, asymptomatic grade 3 elevation of serum transaminases that return to ≤grade 1 within 14 days of completing mithramycin administration, and asymptomatic electrolyte abnormalities that are correctable to grade2 or less within 48h.|Cycle 1 of therapy (or 28 days)|Hepatotoxicity||Participants|||Count of Participants
677283|NCT01610570|Secondary|Volume of Distribution at Steady State (Vss)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Analysis was performed using the Phoenix 6.3 with WinNonlin noncompartmental method.|Prior to and at the completion of the first dose of mithramycin during cycle 1 (28 days) on both the phase I and phase II portion of the trial|After dose-limiting hepatotoxicity was observed in the 1st 2 adult patients (pts), the protocol was subsequently amended to allow PK analysis prior to and at the completion of the first dose during cycle 1 on both the ph 1 & 2 portions of the trial in consenting pts. PK sampling was not mandatory, thus not all pts (i.e. 4/8 pts) had PK analysis.||L||Standard Deviation|Mean
677284|NCT01610570|Secondary|Clearance at Steady State (CLss)|The CL is a quantitative measure of the rate at which a drug substance is removed from the body. Analysis was performed using the Phoenix 6.3 with WinNonlin noncompartmental method.|Prior to and at the completion of the first dose of mithramycin during cycle 1 (28 days) on both the phase I and phase II portion of the trial|After dose-limiting hepatotoxicity was observed in the 1st 2 adult patients (pts), the protocol was subsequently amended to allow PK analysis prior to and at the completion of the first dose during cycle 1 on both the ph 1 & 2 portions of the trial in consenting pts. PK sampling was not mandatory, thus not all pts (i.e. 4/8 pts) had PK analysis.||L/h||Standard Deviation|Mean
677285|NCT01610570|Secondary|Area Under the Curve for the Dosing Interval (AUCtau)|AUCtau is AUC for the dosing interval. Analysis was performed using the Phoenix 6.3 with WinNonlin noncompartmental method.|Prior to and at the completion of the first dose of mithramycin during cycle 1 (28 days) on both the phase I and phase II portion of the trial|After dose-limiting hepatotoxicity was observed in the 1st 2 adult patients (pts), the protocol was subsequently amended to allow PK analysis prior to and at the completion of the first dose during cycle 1 on both the ph 1 & 2 portions of the trial in consenting pts. PK sampling was not mandatory, thus not all pts (i.e. 4/8 pts) had PK analysis.||h*ng/mL||Standard Deviation|Mean
677286|NCT01610570|Secondary|Area Under the Curve Extrapolated to Infinity (AUCinf)|AUC is a measure of the serum concentration of mithramycin over time. It is used to characterize drug absorption. Analysis was performed using the Phoenix 6.3 with WinNonlin noncompartmental method.|Prior to and at the completion of the first dose of mithramycin during cycle 1 (28 days) on both the phase I and phase II portion of the trial|After dose-limiting hepatotoxicity was observed in the 1st 2 adult patients (pts), the protocol was subsequently amended to allow PK analysis prior to and at the completion of the first dose during cycle 1 on both the ph 1 & 2 portions of the trial in consenting pts. PK sampling was not mandatory, thus not all pts (i.e. 4/8 pts) had PK analysis.||h*ng/mL||Standard Deviation|Mean
677287|NCT01610570|Secondary|Half-Life (HL) of Mithramycin|Plasma decay half-life is the time measured for the plasma concentration of the drug to decrease by one half. Analysis was performed using the Phoenix 6.3 with WinNonlin noncompartmental method.|Prior to and at the completion of the first dose of mithramycin during cycle 1 (28 days) on both the phase I and phase II portion of the trial|After dose-limiting hepatotoxicity was observed in the 1st 2 adult patients (pts), the protocol was subsequently amended to allow PK analysis prior to and at the completion of the first dose during cycle 1 on both the ph 1 & 2 portions of the trial in consenting pts. PK sampling was not mandatory, thus not all pts (i.e. 4/8 pts) had PK analysis.||hours||Standard Deviation|Mean
677288|NCT01610570|Secondary|Maximum Plasma Concentration (Cmax) of Mithramycin Using Non-Compartmental Methods|The maximum observed analyte concentration in serum was reported. Mithramycin plasma concentrations were measured using high-performance liquid chromatography tandem mass spectroscopic method, and analysis was performed using the Phoenix 6.3 with WinNonlin noncompartmental method.|Prior to and at the completion of the first dose of mithramycin during cycle 1 (28 days) on both the phase I and phase II portion of the trial|After dose-limiting hepatotoxicity was observed in the 1st 2 adult patients (pts), the protocol was subsequently amended to allow PK analysis prior to and at the completion of the first dose during cycle 1 on both the ph 1 & 2 portions of the trial in consenting pts. PK sampling was not mandatory, thus not all pts (i.e. 4/8 pts) had PK analysis.||ng/mL||Standard Deviation|Mean
677289|NCT01610570|Secondary|Change in Tumor Burden Measured by the World Health Organization (WHO) Criteria|Per the WHO criteria, progressive disease is a 25% increase in tumor lesions, or the appearance of any new measureable or non-measureable tumor lesions. Partial response is ≥50% decrease in tumor lesions. Complete response is disappearance of all tumor lesions. Stable disease is 50% decrease in tumor lesions compared to baseline, nor 25% increase compared with nadir.|≥4 weeks from baseline|This outcome measure was not done due to insufficient patients accrued. Study was closed to enrollment before dose level 1 was completed.|||||
677290|NCT01610570|Secondary|Change in Tumor Burden Measured by the Response Evaluation Criteria in Solid Tumors (RECIST)|Measurable disease were to be quantified using volumetric magnetic resonance imaging analysis per the RECIST, measuring soft tissue disease. Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes. Complete response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions. Progressive disease (PD) is at least a 20% increase in the sum of the diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (Note: the appearance of one or more new lesions is also considered progressions). Stable disease (SD) is neither shrinkage to qualify for PR nor sufficient increase to qualify for PD.|≥4 weeks from baseline|This outcome measure was not done due to insufficient patients accrued. Study was closed to enrollment before dose level 1 was completed.|||||
677291|NCT01610570|Secondary|Count of Participants With NR0B1 Expression in Tumor Biopsies|Biopsies were to be obtained in adult patients who have disease that could be safely biopsied.|Pre-treatment and day 4 (+/- 1 day)|This outcome measure was not done because none of the adult patients on this study had disease that was deemed accessible.|||||
677292|NCT01610570|Secondary|Time to Progression (TTP)|TTP is defined as the number of days from enrollment until disease progression, death because of treatment complications, resection of measureable tumor, or last patient follow-up, whichever comes first, assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions. Progressive disease (PD) is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (Note: the appearance of one or more new lesions is also considered progressions). Stable disease (SD) is neither shrinkage to qualify for PR nor sufficient increase to qualify for PD.|At date of progression|This outcome measure was not done due to insufficient patients accrued. Study was closed to enrollment before dose level 1 was completed.|||||
677293|NCT01610570|Secondary|Objective Response Rate (Complete Response (CR) + Partial Response (PR))|Objective response in children and adolescents with Ewings sarcoma - friend leukemia integration 1 transcription factor to mithramycin is defined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions.|1-2 months|This is a phase II objective, thus phase I groups are not shown here.||participants|||Number
677294|NCT01610570|Primary|Number of Participants With Serious and Non-serious Adverse Events|Here is the number of participants with serious and non-serious adverse events. For a detailed list of serious and non-serious adverse events see the adverse event module.|95 days|||Participants|||Count of Participants
677295|NCT01610570|Primary|Maximum Tolerated Dose (MTD) of Mithramycin|The MTD will be the maximum dose at which fewer than one-third of patients experience Dose Limiting Toxicity (DLT) (i.e., non-hematologic toxicity and hematologic toxicity) during cycle 1 (or 28 days) of therapy.|Cycle 1 of therapy (or 28 days)|MTD was not determined because based on pharmacokinetic data, a clinically relevant dose could not be obtained with the dose strategy. A minimum of 3 patients must be enrolled on a dose level to complete that dose level. Because only 2 patients were enrolled on phase I portion of the trial, dose level 1 was not completed and an MTD was not reached.|||||
677296|NCT01610557|Secondary|Change in Central Retinal Thickness Assessed by Optical Coherence Tomography (OCT) Central Subfield Mean Thickness (CSMT) From Baseline to 36 Weeks (Crossover Phase of the Study)|Optical Coherence Tomography (OCT) scans were graded in masked fashion by Duke University Reading Center (Durham, North Carolina). Per the initial protocol specifications, OCT scans were to be performed on a Cirrus OCT machine; however, some scans were performed on a Spectralis OCT machine at one of the sites due to technical difficulties. The protocol was amended to allow for Cirrus and Spectralis OCT scans at subsequent visits at the affected site. Spectralis values were then converted to Cirrus central subfield mean thickness (CSMT) values through a validated linear conversion function.|Baseline and 36 Weeks|A total of 56 participants (62 eyes) were enrolled and 55 participants (61 eyes) completed the 36-week crossover phase of the study.||micrometers|Participants|95% Confidence Interval|Mean
677297|NCT01610557|Primary|Mean Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) From Baseline to 36 Weeks (Crossover Phase of the Study)|"The primary outcome for 3-months change in BCVA utilized data from Weeks 12, 24 and 36 aggregated in a linear mixed-effects model. This model included adjustments accounting for period (i.e., Weeks 12, 24 and 36), treatment in current period, treatment in prior period, and baseline BCVA to provide the estimated 3-month BCVA change.
Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20."|Baseline and 36 Weeks|A total of 56 participants (62 eyes) were enrolled and 55 participants (61 eyes) completed the 36-week crossover phase of the study.||ETDRS letters|Participants|95% Confidence Interval|Mean
677342|NCT01610297|Secondary|Change in Serum Ferritin Level.|Blood samples were collected and serum levels were assessed at study baseline (BL) and at 12 months.|Baseline, 12 Months|The Full Analysis Set (FAS) comprises all patients in whom study treatment has been started and received at least one dose.||ng/mL||Standard Deviation|Mean
677344|NCT01610167|Secondary|Extended Sensitivity Relief. Air Blast Sensitivity.|Assessment of cold air sensitivity. Cold air sensitivity measurements performed using a cold air blast and sensitivity scored on the four (4) point Schiff scale with 0 equal to no discomfort or awareness of sensitivity and 3 equal to severe pain from sensitive teeth.|28 days (+/- 2 days) post treatment.|||units on a scale||Standard Deviation|Mean
677343|NCT01610297|Primary|Number of Participants With Adverse Events, Serious Adverse Events and Deaths as a Measure of Safety and Tolerability|To determine the safety; incidence, type and severity of adverse events including renal, hepatic, biochemistry and hematologic parameters of deferasirox in the treatment of iron overload after hematopoietic stem cell transplantation (HSCT) in patients with beta-thalassemia major in 12 months period|12 months|The Safety Set (SS) includes all included patients who were included in the study. All statistical analyses of safety and tolerability will be done in the SS.||Participants|||Number
677337|NCT01610453|Secondary|Percentage of Women With Cesarean Section|The percentage of women with cesarean section was compared in cases with occiput posterior position and cases with non occiput posterior position assessed with transabdominal sonography when prolonged labor was diagnosed.|active labor|Fetal head position was assessed successfully using transabdominal ultrasound in 142/150 women. Position could not be diagnosed in eight cases due to shadowing from maternal pelvis in cases at low stations.||percentage of participants in each group|||Number
677338|NCT01610453|Primary|Percentage of Women With Vaginal Deliveries|Women were categorized in accordance to fetal descent measured by ultrasound. Head-perineum distance (HPD) ≤40 mm and angle of progression (AoP) ≥110 degrees were used as cut-off level. HPD was obtained in all 150 cases and AoP was successfully obtained in 145 cases.|active labor|AoP could not be measured in 5 cases because only a part of the symphysis was visualized.||percentage of participants in each group||95% Confidence Interval|Number
677339|NCT01610297|Secondary|Change in the Further Parameters of Iron Overload (Cardiac Iron Concentration by Magnetic Resonance Imaging (MRI Examination)|Cardiac MRI values between 10 to 20 milliseconds (ms) are indicative of moderate cardiac iron deposition associated with declining left ventricular ejection fraction and arrhythmias while values <10 ms are indicative of deposition sufficient to risk cardiac decompensation and associated with overt heart failure and mortality.|Baseline, 12 month|The Full Analysis Set (FAS) comprises all patients in whom study treatment has been started and received at least one dose.||ms||Standard Deviation|Mean
677340|NCT01610297|Secondary|The Percentage of Patients Reaching Serum Ferritin Levels Lower Than 500 μg/L|Serum Ferritin values between 1000-2500 μg/L are indicative of mild to moderate iron overload while values >2500 μg/L are indicative of severe iron overload and levels constantly higher than 2500 μg/L has been shown to to increase the risk of cardiac complications and endocrine disease. Maintaining levels <1000 μg/L is associated with increased survival and less morbidity.|Week 28 and Week 52|The Full Analysis Set (FAS) comprises all patients in whom study treatment has been started and received at least one dose.||Percentage of Patients|||Number
677341|NCT01610297|Secondary|Change in the Further Parameters of Iron Overload (Liver Iron Concentration by Magnetic Resonance Imaging (MRI Examination)|Liver Iron Concentration (LIC) values between 3 and 7 mg Fe / g dry weight are indicative of mild iron deposition, while values between 7 and 15 mg Fe / g dry weight are indicative of moderate iron deposition which have been associated with liver disease. Values >15 mg Fe/g dry weight are indicative of severe iron deposition which is associated with progressive liver fibrosis, increased morbidity and mortality|Baseline, 12 month|The Full Analysis Set (FAS) comprises all patients in whom study treatment has been started and received at least one dose.||mg Fe/g dry liver weight||Standard Deviation|Mean
677345|NCT01610167|Primary|Immediate Sensitivity Relief. Air Blast Sensitivity.|Sensitivity measurements performed using a cold air blast and sensitivity scored on the four (4) point Schiff scale with 0 equal to no discomfort or awareness of sensitivity and 3 equal to severe pain from sensitive teeth. Score is reported as the change from baseline after treatment.|Immediately after treatment.|||units on a scale||Standard Deviation|Mean
677346|NCT01610167|Secondary|Extended Sensitivity Relief. Tactile Sensitivity.|"Assessment of sensitivity score via tactile stimulation 28 days post treatment. Tactile sensitivity measured using a Yeaple probe recording tactile pressure in grams before nerve stimulation. Point of nerve stimulation identified by patient with yes response as pressure is increased in 10 gram increments. Measured sensitivity is reported as difference from baseline examination."|28 days (+/- 2 days) post treatment.|Intent to treat (ITT).||grams||Standard Deviation|Mean
677347|NCT01610167|Primary|Adverse Events.|Assessment of adverse events that may occur as a result of treatment (typically includes any kind of allergic reation to paste).|Immediately after treatment to 28 days (+/- 2 days) post treatment.|Intent to treat (ITT).||Number of adverse events.|||Number
677348|NCT01610167|Primary|Immediate Sensitivity Relief. Tactile Sensitivity.|"Assessment of sensitivity via tactile stimulation immediately after treatment. Tactile sensitivity measured using a Yeaple probe recording tactile pressure in grams before nerve stimulation. Point of nerve stimulation identified by patient with a yes response as pressure is increased in 10 gram increments. Tactile sensitivity is reported as the change from baseline after treatment."|Immediately after treatment.|Intention to treat (ITT).||grams||Standard Deviation|Mean
677349|NCT01610154|Secondary|Change From Baseline in Pancreatic α Cell Function in Patients With Different BMI|The glucagon-AUC was adopted to show pancreatic α cell function.|Baseline to 12 weeks|||min∙pg/ml||Standard Deviation|Mean
677350|NCT01610154|Secondary|Change From Baseline in Pancreatic α Cell Function|The glucagon-AUC was adopted to show pancreatic α cell function.|Baseline to 12 weeks|||min∙pg/ml||Standard Deviation|Mean
677351|NCT01610154|Secondary|Change From Baseline in Pancreatic β Cell Function in Patients With Different BMI|The early phase insulin response (△I30/△G30) was adopted to determine β cell function.|Baseline to 12 weeks|||μu/ml/mmol||Inter-Quartile Range|Median
677352|NCT01610154|Secondary|Change From Baseline in Pancreatic β Cell Function|The early phase insulin response (△I30/△G30) was adopted to determine β cell function.|Baseline to 12 weeks|||μu/ml/mmol||Inter-Quartile Range|Median
677353|NCT01610154|Secondary|Change From Baseline in Insulin Sensitivity in Patients With Different BMI|The insulin sensitivity was detected by evaluating the glucose infusion rate (GIR) with euglycemic hyperinsulinemic clamp test.|Baseline to 12 weeks|||mg/kg/min||Inter-Quartile Range|Median
677354|NCT01610154|Secondary|Change From Baseline in Insulin Sensitivity|The insulin sensitivity was detected by evaluating the glucose infusion rate (GIR) with euglycemic hyperinsulinemic clamp test.|Baseline to 12 weeks|||mg/kg/min||Inter-Quartile Range|Median
677355|NCT01610154|Secondary|Change From Baseline in Postprandial Plasma Glucose (PPG)||Baseline to 12 weeks|||mmol/L||Standard Deviation|Mean
677356|NCT01610154|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)||Baseline to 12 weeks|||mmol/L||Standard Deviation|Mean
677357|NCT01610154|Primary|Change From Baseline in Hemoglobin A1c (HbA1c)||Baseline to 12 weeks|||percentage||Standard Deviation|Mean
677358|NCT01610076|Secondary|Willingness to Recommend Video to Other Patients|"Participants were surveyed, Would you recommend this video to other patients? Three options were provided:
Definitely recommend Probably recommend Do not recommend"|immediately after intervention|||participants|||Number
677359|NCT01610076|Secondary|Perception of Utility of Video|"Participants were surveyed, How helpful was this video in helping you understand your options? There possible answers were provided:
Very helpful Somewhat helpful Not helpful"|immediately after intervention|||participants|||Number
677360|NCT01610076|Secondary|Participant Reported Comfort With Video Intervention|"Patient's were surveyed about How comfortable were you watching the video?"|immediately after intervention|Patient's surveyed about||participants|||Number
677361|NCT01610076|Primary|12 Question Resuscitation Status Survey (Question 4 Has 4 Sub-questions)|"12 question (question 4 has 4 sub-questions) survey previously validated to determine knowledge level about resuscitation status with total score on the scale of 0-15. Possible scores ranged from 0 to 15, with higher scores representing increased medical knowledge.
The CPR knowledge survey assesses a participants basic understanding of cardiopulmonary resuscitation (CPR). The survey consisted of 12 questions with one point being awarded for each correct response. Question four had a total of four possible correct answers. Thus the scores on the scale of 0-15 points is designed, with higher scores representing increased knowledge."|after admission to ICU, approx one hour|||points||Inter-Quartile Range|Median
677362|NCT01610063|Secondary|Remitters at Week 8|Definitions of the depression questionnaires are found in previous outcome measures. Definition of remitter: a participant with score less than or equal to certain value (HAMD-17 <=7, QIDS-C16<=5, PHQ-9<5).|baseline, 8 weeks|||percentage of participants|||Number
677363|NCT01610063|Secondary|Responders at Week 8|Definitions of the depression questionnaires are found in previous outcome measures. Definition of responder: a participant who had 50% or higher reduction in psychiatric score from baseline.|baseline, 8 weeks|||percentage of participants|||Number
677364|NCT01610063|Secondary|Physicians' Perception of Participant's Satisfaction With Their Care|Physicians reported on their perception of each participant’s satisfaction with their care only for patients who completed the 8-week study. Physicians were directed to complete a survey for each participant detaining their experience during the study period.|8-week visit|Physicians completed surveys for 89 participants (96%) from the unguided group, and for 37 participants (51.4%) from the guided group. For each row below, the number of subjects analyzed is indicated by (n=guided, unguided) arms. For the first row, one of the physicians who completed the survey did not answer this question.||percentage of physicians|||Number
677365|NCT01610063|Secondary|Pharmacogenomic Report Utilization|Physicians were directed to complete a survey for each participant detailing their experiences during the study period.|baseline, 8-week visit|The medication changes of patients were recorded only for patients who completed the 8-week study (n=72,93 for guided and unguided arms). For each row below, the number of subjects analyzed is indicated by (n=guided, unguided) arms.||percentage of participants|||Number
677366|NCT01610063|Secondary|Percentage Change in Outcome by Bin Status and Treatment Group|"The Genesight algorithm presents recommendations for antidepressants and antipsychotics in bin status associated with colors. Green indicates Use as Directed. Yellow indicates Use with Caution. Red indicates Use with Increased Caution and with More Frequent Monitoring. Definitions of the depression questionnaires are found in previous outcome measures. A negative change indicates improvement in the subject's depression/anxiety symptoms, and a positive change indicates a worsening of the subject's depression/anxiety symptoms."|baseline, 8-week visit|All subjects were evaluated for a bin status, but not all the arms had subjects assigned to every bin status (green, yellow, or red). Bin status for each category title is reported as (n=Guided, Unguided).||Percentage change||Standard Deviation|Mean
677367|NCT01610063|Secondary|Percentage Change in Patient Health Questionnaire-9 (PHQ-9) Score From Baseline|The PHQ-9 is the nine item depression scale of the Patient Health Questionnaire. The PHQ-9 is based directly on the diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual Fourth Edition (DSM-IV). Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 (no symptoms) and 27 (severe symptoms) for depression. A negative change indicates improvement in the subject's depression symptoms, and a positive change indicates a worsening of the subject's depression symptoms.|baseline, 8-week visit|There were 8 out of 72 patients in the guided arm and 12 out of 93 patients in the unguided arm who did not have assigned medication color in green/yellow/red. The number analyzed per row is indicated as (n=guided,unguided). One subject in the guided arm (green/yellow) did not complete the PHQ-9 questionnaire at 8 weeks.||Percentage change in depression rating||Standard Deviation|Mean
677368|NCT01610063|Secondary|Percentage Change in Hamilton Depression Rating Scale (HAMD-17) Score From Baseline|The HAMD-17 is a 17-item scale that evaluates depressed mood, vegetative and cognitive symptoms of depression, and co-morbid anxiety symptoms. The 17 items are rated on either a 5-point (0-4) or a 3-point (0-2) scale. In general, the 5 point scale items use a rating of 0=absent; 1=doubtful to mild; 2=mild to moderate; 3=moderate to severe; 4=very severe. The 3-point scale items use a rating of 0=absent; 1=probable or mild; 2=definite. The total HAMD-17 score ranges from 0 (not ill) to 52 (severely ill). A negative change indicates improvement in the subject's depression/anxiety symptoms, and a positive change indicates a worsening of the subject's depression/anxiety symptoms.|baseline, 8-week visit|This analysis was performed on subjects who completed the study. There were 8 out of 72 patients in the guided arm and 12 out of 93 patients in the unguided arm who did not have assigned medication color in green/yellow/red. The number analyzed per row is indicated as (n=guided,unguided).||Percentage change in depression rating||Standard Deviation|Mean
677369|NCT01610063|Primary|Percentage Change in Quick Inventory of Depressive Symptomatology (QIDS-C16) Score From Baseline|The QIDS-C16 is a 16-item scale that is clinician-rated; it is designed to assess the severity of depressive symptoms. The QIDS-C16 total score ranges from 0-27. Scores ranging from 0 to 10 correspond with no to mild depression, while scores >/= 11 correspond to moderate to severe depression. A negative change indicates improvement in the subject's depression, and a positive change indicates a worsening of the subject's depression.|baseline, 8-week visit|This analysis was performed on subjects who completed the study. There were 8 out of 72 patients in the guided arm and 12 out of 93 patients in the unguided arm who did not have assigned medication color in green/yellow/red. The number analyzed per row is indicated as (n=guided,unguided).||Percentage change in depression rating||Standard Deviation|Mean
677370|NCT01610037|Secondary|Change From Baseline in 1 Hour Post-dose FEV1 Measurements|The avg 60 min post dose forced expiratory volume in 1 second (FEV1) at visit 4, 5, 6, 7, 8 and 9 will be analyzed.|Day 1, 22, 43, 85, 183, 274 and 364|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug. Patients were analyzed according to the treatment they were assigned to at randomization. If the patient was assigned to the wrong stratum for randomization, the patient was analyzed according to the actual (rather than assigned) stratum||Liters||Standard Deviation|Mean
677371|NCT01610037|Secondary|Time to Premature Discontinuation|Time to premature treatment discontinuation for each treatment group was displayed using a Kaplan-Meier curve. The date of last dose of study medication was considered as the event date and also as the censoring date for those patients who did not discontinue treatment early. The range of the ‘time to treatment discontinuation’ varied from 5-407 days in the Tiotropium group. Hence the model estimated lower limit of the median time to treatment discontinuation is greater than the scheduled treatment period of 52 weeks.|Time varied from 5 - 407 days|The Safety set consisted of all patients that received at least one dose of study medication and had at least one post-baseline safety assessment. Patients were analyzed according to treatment received.||Days||95% Confidence Interval|Median
677372|NCT01610037|Secondary|Change From Baseline in 1 Hour Post-dose Forced Vital Capacity (FVC) Measurements|Pulmonary function assessments were performed using centralized spirometry according to international standards|Day 1, 22, 43, 85, 183, 274 and 364|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug. Patients were analyzed according to the treatment they were assigned to at randomization. If the patient was assigned to the wrong stratum for randomization, the patient was analyzed according to the actual (rather than assigned) stratum||Liters||Standard Deviation|Mean
677373|NCT01610037|Secondary|Change From Baseline in Percentage of Days Able to Perform Usual Daily Activities.|A day able to perform usual daily activities’ is defined from diary data as any day where the patient was not prevented from performing their usual daily activities due to respiratory symptoms.|52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug. Patients were analyzed according to the treatment they were assigned to at randomization. If the patient was assigned to the wrong stratum for randomization, the patient was analyzed according to the actual (rather than assigned) stratum||Percentage of days||Standard Deviation|Mean
677374|NCT01610037|Secondary|Change From Baseline in Percentage of no Daytime Symptoms|A day with ‘no daytime symptoms’ is defined from the diary data as any day where the patient has recorded in the evening no cough, no wheeze, no production of sputum and no feeling of breathlessness (other than when running) during the past 12 hours (approx. 8 am to 8 pm).|52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug. Patients were analyzed according to the treatment they were assigned to at randomization. If the patient was assigned to the wrong stratum for randomization, the patient was analyzed according to the actual (rather than assigned) stratum||Percentage of days||Standard Deviation|Mean
677375|NCT01610037|Secondary|Change From Baseline in Percentage of Nights With ‘no Nighttime Awakenings|A night with ‘no nighttime awakenings’ is defined from diary data as any night where the patient did not wake up due to symptoms.|52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug. Patients were analyzed according to the treatment they were assigned to at randomization. If the patient was assigned to the wrong stratum for randomization, the patient was analyzed according to the actual (rather than assigned) stratum||Percentage of nights||Standard Deviation|Mean
677376|NCT01610037|Secondary|Change From Baseline in Daily, Morning and Evening Symptom Scores|Patients will be provided with an electronic diary (eDiary) to record daily clinical symptoms, or rescue medication. The patients will be instructed to routinely complete the patient diary twice daily. There are 9 total symptom questions for a total possible score of 27 at each timepoint. A higher score means the patient is reporting more symptoms related to Chronic Obstructive Pulmonary Disease. The mean daily total symptom score, the mean daytime total symptom score and the mean nighttime total symptom score were calculated for each patient over 52 weeks. Diary data recorded during the 14 day run-in period were used to calculate the baseline.|52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug. Patients were analyzed according to the treatment they were assigned to at randomization. If the patient was assigned to the wrong stratum for randomization, the patient was analyzed according to the actual (rather than assigned) stratum||Score||Standard Deviation|Mean
677377|NCT01610037|Secondary|Change From Baseline in Health Status as Measured by St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C)|"The SGRQ-C contains 40 items divided into two parts covering three aspects of health related to COPD: Part I covers Symptoms and is concerned with respiratory symptoms, their frequency and severity; Part II covers Activity and is concerned with activities that cause or are limited by breathlessness; Part II is also concerned with Impacts which covers a range of aspects concerned with social functioning and psychological disturbances resulting from airways disease. A score will be calculated for each of these three subscales and a Total score will also be calculated. In each case the lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status."|Measurment at day 364|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug. Patients were analyzed according to the treatment they were assigned to at randomization. If the patient was assigned to the wrong stratum for randomization, the patient was analyzed according to the actual (rather than assigned) stratum||Score||Standard Deviation|Mean
677378|NCT01610037|Secondary|Change From Baseline in Pre-Dose Forced Expiratory Volume Over in Second (FEV1)|Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1.|Day 22, 43, 85, 183, 274 and 364|The full analysis set (FAS) included all randomized patients who eceived at least one dose of study drug. Patients were analyzed according to the treatment they were assigned to at randomization. If the patient was assigned to the wrong stratum for randomization, the patient was analyzed according to the actual (rather than assigned) stratum||Liters||Standard Error|Least Squares Mean
677379|NCT01610037|Secondary|Post-hoc Analysis: Percentage of Patients With Composite Endpoint of Cardiovascular Death and MACE|The composite endpoint included all deaths and all serious CCV events, including MACE and events which were not considered MACE. A rigorous post hoc analysis was done on composite endpoint of CV deaths and major adverse cardiovascular events (MACE). The patients with an event in the analysis were those who had at least one of the 2 events namely, CV deaths and MACE, during treatment or within 30 days after the date of last dose of study drug.|52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug. Patients were analyzed according to the treatment they were assigned to at randomization. If the patient was assigned to the wrong stratum for randomization, the patient was analyzed according to the actual (rather than assigned) stratum.||Percentage of participants|||Number
677380|NCT01610037|Secondary|Percentage of Patients With Composite Endpoint of All-cause Mortality, and Serious Cardio- and Cerebrovascular (CCV) Events.|The endpoint of all-cause mortality and serious CCV events (composite) was chosen to further characterize any discernible risks. The patients with an event in the analysis were those who had at least one of the 2 events namely, all-cause mortality and serious CCV, during treatment or within 30 days after the date of last dose of study drug.|52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug. Patients were analyzed according to the treatment they were assigned to at randomization. If the patient was assigned to the wrong stratum for randomization, the patient was analyzed according to the actual (rather than assigned) stratum.||Percentage of participants|||Number
677381|NCT01610037|Primary|Number of Patients With Serious Adverse Events|The overall rate of serious adverse events reported from initiation through 30 days post last dose.|Week 52|The safety set included all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. Patients were analyzed according to treatment received. A patient who had no adverse events also constitutes a safety assessment.||Participants|||Number
677382|NCT01610011|Primary|Brain Glycine Increments After Oral Glycine Administration Measured With MRS as Glycine/Total Creatine, Normalized to the Glycine Dose Administered (g/kg).|Brain and plasma glycine levels are measured with proton magnetic resonance spectroscopy at 4T and analytically, respectively. Because glycine doses were limited to 30 g to avoid nausea and vomiting, some subjects with higher weights were administered lower doses per body weight of glycine (g/kg). Therefore, we corrected MRS data by the actual glycine dose administered (g/kg) to account for dosing differences.|For up to 2 hours|Subjects completing the magnetic resonance spectroscopy study.||Percent brain glycine/creatine increase|Participants|Standard Error|Mean
677383|NCT01609790|Other Pre-specified|Tumor Genotype, Expression Profile, and Circulating Angiogenesis Biomarkers (Cohort 2)|Biomarker data has not yet been obtained and therefore this outcome measure cannot yet be reported.|From randomization to date of death or last followup. Statistical analysis occurs when tumor genotype, expression profile and circulating angiogenesis biomarkers have been determined from the tissue specimens.||||||
677384|NCT01609790|Secondary|Feasibility of Trebananib Weekly in Combination With Bevacizumab Every 2 Weeks, Measured by the Percentage of Patients Requiring Dose Reduction/Interruption or Discontinuation in the First 2 and Subsequent Courses (Cohort 1)||From randomization up to 3 years.||||||
677385|NCT01609790|Secondary|Radiographic Response Rate (Cohort 2)|Proportion of patients with best overall response of complete response (CR) or partial response (PR) recorded from the start of the treatment until disease progression/recurrence. Response determined by site-reported radiology review of MRI exams using Response Assessment in Neuro-Oncology Criteria (RANO) criteria. CR: Complete disappearance of all enhancing measurable disease (MD) + non-measurable disease (NMD) sustained >= 4 wks; No new lesions; Stable or improved non-enhancing (T2/FLAIR) lesions; Off corticosteroids (or on physiologic replacement doses only); Stable/improved clinically. PR: >= 50% decrease vs. baseline of sum of products of perpendicular diameters of all measurable enhancing lesions sustained >= 4 wks; No progression of NMD; No new lesions; Stable/improved non-enhancing (T2/FLAIR) lesions on <= dose of corticosteroids vs. baseline scan; Corticosteroid dose at evaluation scan <= baseline scan dose; Stable or improved clinically. NMD only cannot be a CR or PR.|From randomization up to 3 years.|All randomized and eligible patients.||percentage of participants||95% Confidence Interval|Number
677386|NCT01609790|Secondary|Progression-free Survival (Cohort 2)|Progression-free survival time is measured from randomization to the date of first progression or death or, otherwise, the last follow-up date on which the patient was reported alive. This analysis was planned to occur when all patients had been potentially followed for at least 6 months.|From randomization up to 3 years.|All randomized and eligible patients.||percentage of participants||95% Confidence Interval|Number
677387|NCT01609790|Secondary|Overall Survival (Cohort 2)|Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. This analysis was planned to occur when all patients had been potentially followed for at least 6 months.|From randomization up to 3 years.|All randomized and eligible patients.||Months||95% Confidence Interval|Median
677388|NCT01609790|Secondary|Incidence of Grade 3+ Treatment-related Toxicity, Measured by CTCAE v. 4 (Cohort 2)|Adverse events (AEs) are graded by using CTCAE 4.0. Possibly/probably/definitely related to protocol treatment AEs are considered.|From start of treatment up to 3 years.|Randomized and eligible patients who started protocol treatment.||participants|||Number
677389|NCT01609790|Primary|Six-month Progression-free Survival (Cohort 2)|As determined by central review of MRI exams, assessed using RANO criteria for progression that is defined by any of the following: > 25% increase in sum of the products of perpendicular diameters of enhancing lesions compared to the smallest tumor measurement obtained either at baseline (if no decrease) or best response, on stable or increasing doses of corticosteroids; Significant increase in T2/FLAIR non-enhancing lesion on stable or increasing doses of corticosteroids compared to baseline scan or best response following initiation of therapy, not due to co-morbid events; Any new lesion; Clear clinical deterioration not attributable to other causes apart from the tumor or changes in corticosteroid dose; Failure to return for evaluation due to death or deteriorating condition; Clear progression of non-measurable disease.|From randomization to six months.|Randomized patients evaluable for 6 months progression-free survival (PFS).||percentage of participants||95% Confidence Interval|Number
677390|NCT01609790|Primary|Incidence of Dose-limiting Toxicity (Cohort 1)|Dose-limiting toxicity (DLT), defined as a clinically significant adverse event or abnormal laboratory value assessed as unrelated to disease progression, intercurrent illness, or concomitant medications and meets any of the criteria below. Any DLT must be a toxicity possibly related to protocol treatment during first 4 weeks: grade 4 hematologic toxicity, grade 3/4 thrombocytopenia, or grade 3/4 non-hematologic toxicity; Gastrointestinal fistula, bowel perforation, intracranial hemorrhage, wound dehiscence, or reversible posterior leukoencephalopathy of any grade; Delay of treatment > 28 days. If 2+ of patients experience a DLT among 6 eligible patients, this drug combination will be considered unsafe and a lower dose of AMG will be explored; otherwise conclude that this drug combination is safe. The probability of claiming safe dose is no more than 16% when the true DLT rate is >45%, and the probability of claiming safe dose is at least 78% when the true DLT rate is <= 15%.|From start of treatment to 4 weeks.|All eligible patients who started study treatment||participants|||Number
677391|NCT01609582|Secondary|Time to First Occurrence of Any Component of Secondary Major Adverse Cardiovascular Event (MACE) Composite|The time from randomization to the first occurrences of any event in the secondary MACE composite was evaluated using Kaplan-Meier analysis. The secondary MACE composite comprised CV death, nonfatal MI, and nonfatal stroke.|Baseline up to end of study (up to Day 588)|Full Analysis Set (FAS) included all randomized participants who had baseline and at least 1 post-baseline assessment.||days||95% Confidence Interval|Median
677392|NCT01609582|Primary|Time to First Occurrence of Any Component of Primary Major Adverse Cardiovascular Event (MACE) Composite|The time from randomization to the first occurrences of any event in the primary MACE composite was evaluated using Kaplan-Meier analysis. The primary MACE composite comprised cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, and hospitalization for unstable angina (with or without revascularization).|Baseline up to end of study (up to Day 588)|Full Analysis Set (FAS) included all randomized participants who had baseline and at least 1 post-baseline assessment.||days||95% Confidence Interval|Median
677393|NCT01609543|Secondary|Percentage of Participants Who Were Alive at 1 Year||1 Year (12 months)|ITT population. Here, number of participants analyzed signifies those participants who were evaluable for this outcome.||Percentage of Participants|||Number
677394|NCT01609543|Secondary|Percentage of Participants With Best Overall Response (BOR)|BOR was defined as best tumor response (as per RECIST version 1.1) recorded for a participant during the study. Complete Response (CR): disappearance of all target and non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (less than [<] 10 millimeters [mm] short axis). Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. The appearance of one or more new lesions is also considered progression. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|Baseline to progressive disease or death (up to 34 months)|ITT population.||Percentage of Participants|||Number
677429|NCT01609257|Secondary|Pan-Ig ELISA - Anti-Norovirus GII.4 cVLP GMT||Baseline, 28 days post Dose 1 and 28 days post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.||titer||95% Confidence Interval|Geometric Mean
677395|NCT01609543|Primary|Progression-Free Survival (PFS)|PFS was defined as median time from the first dose of study treatment to the first documentation of objective tumor progression (according to Response Evaluation Criteria in Solid Tumours [RECIST] version 1.1) or to death due to any cause, whichever occurred first. Progressive Disease (PD) was defined as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. The appearance of one or more new lesions is also considered progression. Median and the 95% confidence interval were estimated using Kaplan-Meier survival methodology.|Baseline to progressive disease or death (up to 34 months)|ITT population.||Months||95% Confidence Interval|Median
677396|NCT01609478|Secondary|Plasma Indacaterol Concentrations at Day 1 and Day 14|Maximum plasma concentration after drug administration (Cmax) was measured for indacaterol acetate 75 µg and indacaterol acetate 150 µg for Pharmacokinetic (PK) Subgroup|Day 1 and Day 14|Pharmacokinetic (PK) profiling subgroup included all randomized patients who consented to participate in the additional PK assessment.||pg/ml||Standard Deviation|Mean
677397|NCT01609478|Secondary|Total Amounts (in Doses) of Systemic Corticosteroids Used to Treat Asthma Exacerbations Over the 12 Week Treatment Period|Total amounts (in doses) of systemic corticosteroids (SCS) used to treat asthma exacerbations.SCS includes Intramuscular (IM), Intravenous (IV) and Oral. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.|12 weeks|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.||milligrams (mg)||Standard Deviation|Mean
677398|NCT01609478|Secondary|The Percentage of Patients Who Permanently Discontinued Study Due to Asthma Exacerbation Over the 12 Week Treatment Period|The percentage of patients who permanently discontinued study due to asthma exacerbation. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.|12 weeks|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.||percentage of participants|||Number
677399|NCT01609478|Secondary|Time to Permanent Study Discontinuation Due to Asthma Exacerbation Over the 12 Week Treatment Period|Time to permanent study discontinuation due to asthma exacerbation. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.|12 weeks|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.||days||95% Confidence Interval|Median
677400|NCT01609478|Secondary|The Percentage of Patients With at Least One Asthma Exacerbation (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period|The percentage of patients with at least one asthma exacerbation by severity of exacerbation. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.|12 weeks|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.||percentage of participants|||Number
677401|NCT01609478|Secondary|Duration of Asthma Exacerbations (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period|Duration of asthma exacerbations by severity of exacerbation. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.|12 weeks|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.||days||Standard Deviation|Mean
677402|NCT01609478|Secondary|The Annual Rate of Asthma Exacerbations (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period|Annual incidence rate of asthma exacerbation by severity of exacerbation. The number of asthma exacerbation is used to calculate annual incidence rate. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations. Number of the asthma exacerbation will be analyzed by the negative binomial regression including treatment, history of asthma exacerbation in the 12 months prior to screening and region as factors and FEV1 prior to inhalation and FEV1 30 min post inhalation of salbutamol/albuterol (components of SABA reversibility) as covariates. The estimates are obtained from the model and so we cannot specify a formula.|12 weeks|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.||# of exacerbations||95% Confidence Interval|Number
677403|NCT01609478|Secondary|Time to First Asthma Exacerbation (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period|Duration of treatment until first asthma exacerbation by severity of exacerbation. A severe asthma exacerbation is systemic corticosteroids (SCS) use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.|12 weeks|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.||weeks||95% Confidence Interval|Median
677404|NCT01609478|Secondary|Asthma Quality of Life Questionnaire (AQLQ(S)) After 4 Weeks (Day 29) and 12 Weeks (Day 85) of Treatment|The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments in asthma. Patients are asked to score each item on a 7-point scale based on the experience of last 2 weeks. The overall AQLQ score is the mean response to all 32 questions. Therefore, the possible highest score (better) would be 7 and the lowest (worse) would be 1. Changes in scores of 0.5 to 1.0 are considered clinically meaningful; 1.0 to 1.5 as moderate and > 1.5 as marked clinically important differences for any individual domain or for the overall summary score.|4 Weeks, 12 Weeks|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.||Units on a Scale||Standard Error|Least Squares Mean
677405|NCT01609478|Secondary|The Usage of Rescue Medication (Short Acting β2-agonist) Over 12 Weeks of Treatment|Participants record the number of puffs of rescue medication taken in the previous 12 hours in the morning and nighttime.|12 weeks|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.||number of puffs||Standard Deviation|Least Squares Mean
677406|NCT01609478|Secondary|Morning and Evening Peak Expiratory Flow Rate (PEFR) Over 12 Weeks of Treatment. This is LS Mean of the Treatment Period.|PEFR is measured with portable spirometer by participants every morning and evening at home.|baseline, 4weeks, 8 weeks and 12 weeks|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.||liters/second||Standard Error|Least Squares Mean
677407|NCT01609478|Secondary|Asthma Control Questionnaire 5 (ACQ-5) After 4 Weeks (Day 29) and After 8 Weeks (Day 57) of Treatment|The ACQ-5 is a validated questionnaire consisting of 5 items for the assessment of asthma symptom which are night symptom, morning symptom, limitation for the activities, shortness of breath, and wheeze. Each item is graded on a scale of 0-6 and the questions are equally weighted. The ACQ-5 score is the mean of the 5 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled).|after 4 weeks (Day 29) and after 8 weeks (Day 57)|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.||units on a scale||Standard Error|Least Squares Mean
677408|NCT01609478|Secondary|Peak Forced Expiratory Volume in 1 Second (FEV1) at Day 1, 2 Weeks (Day 14), 12 Weeks (Day 84)|Peak Forced Expiratory Volume in 1 second (FEV1) was measured via spirometry conducted according to internationally accepted standards. Peak FEV1 is defined as the maximum FEV1 during the first 4 h post morning dosing at Day 1, 2Weeks and 12 Weeks.|Day 1, 2 weeks (Day 14), 12 weeks (Day 84)|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.||liters||Standard Error|Least Squares Mean
677409|NCT01609478|Secondary|Standardized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) at (5 Min - 4 h), (5 Min - 1 h) (1 h - 4 h) Measured on Day 1, 2 Weeks (Day 14)&12 Weeks (Day 84)|Forced Expiratory Volume in 1 second (FEV1)/Area Under the Curve(AUC) was measured via spirometry conducted according to internationally accepted standards.FEV1 AUC(5 min - 4 h), (5 min - 1 h) and (1 h - 4 h) are measured at Day 1, 2 Weeks (Day 14) and 12 Weeks (Day84) and defined as average of FEV1 at specified timepoints above.|Day 1, 2 Weeks, 12 Weeks|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.||Liters||Standard Error|Least Squares Mean
677410|NCT01609478|Secondary|Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85|Forced Expiratory Flow (FEF 25-75%) was measured via spirometry conducted according to internationally accepted standards.|Day 1, Day 2, Day 14, Day 15, Day 84, Day 85|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.||liters/second||Standard Error|Least Squares Mean
677411|NCT01609478|Secondary|Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85|Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) was measured via spirometry conducted according to internationally accepted standards.|Day 1, Day 2, Day 14, Day 15, Day 84, Day 85|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.||ratio||Standard Error|Least Squares Mean
677412|NCT01609478|Secondary|Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points|Forced Vital Capacity (FVC) was measured via spirometry conducted according to internationally accepted standards. FVC is measured on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at all time points|Day 1, Day 2, Day 14, Day 15, Day 84, Day 85|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.||liters||Standard Error|Least Squares Mean
677413|NCT01609478|Secondary|Trough Forced Expiratory Volume in One Second (FEV1) After 2 Weeks (Day 15), 4 Weeks (Day 29), and 8 Weeks (Day 57) of Treatment.|Forced Expiratory Volume in 1 second (FEV1) was measured via spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose after 2 weeks (Day 15), 4 weeks (Day 29), and 8 weeks (Day 57) of treatment.|Day 15, Day 29 and Day 57|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.||Liters||Standard Error|Least Squares Mean
677414|NCT01609478|Secondary|Asthma Control Questionnaire 5 (ACQ-5) After 12 Weeks (Day 85)|The Asthma Control Questionnaire (ACQ-5) is a validated questionnaire consisting of 5 items for the assessment of asthma symptom which are night symptom, morning symptom, limitation for the activities, shortness of breath, and wheeze. The ACQ-5 score is the mean of the 5 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled). A negative change in score indicates improvement in symptoms. MIXED model: Change from baseline in ACQ-5 = treatment + gender + baseline ACQ-5 score + age + level of asthma control + region + center (region) + error. Center is included as a random effect nested within region.|aftert 12 weeks (Day 85)|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.||Units on a Scale||Standard Error|Least Squares Mean
677415|NCT01609478|Primary|Trough Forced Expiratory Volume in One Second (FEV1) After 12 Weeks (Day 85)|Forced Expiratory Volume in 1 second (FEV1) was measured via spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose after 12 weeks (Day 85)|after 12 weeks (Day 85)|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.||Liters||Standard Error|Least Squares Mean
677416|NCT01609257|Secondary|Percentage of Participants With Unsolicited Non-Serious [i.e Other Than SAEs] Adverse Events (AEs)|Unsolicited AEs indicates any and all AEs that occurred other than those that were solicited.|Vaccination Stage: Initial vaccination until 28 days after second vaccination; or Challenge Stage: the day of challenge until 60 days after challenge|MITT population included all participants who received at least one dose of study drug.||percentage of participants||95% Confidence Interval|Number
677417|NCT01609257|Secondary|HBGA (PGM) - Anti-Norovirus GII.4 cVLP GMT||Baseline, 28 days post Dose 1 and 28 days post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.||titer||95% Confidence Interval|Geometric Mean
677418|NCT01609257|Secondary|Percentage of Participants With HBGA (PGM) - Anti-Norovirus GII.4 cVLP Seroresponse From Baseline|Seroresponse was defined as a 4-Fold Rise from Baseline.|Baseline to 28 days post Dose 1 and 28 days post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.||percentage of participants||95% Confidence Interval|Number
677419|NCT01609257|Secondary|HBGA (PGM) - Anti-Norovirus GII.4 cVLP GMFR From Baseline||Baseline to 28 days post Dose 1 and 28 days post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.||ratio||95% Confidence Interval|Geometric Mean
677420|NCT01609257|Secondary|HBGA (PGM) - Anti-Norovirus GI.1 VLP GMT||Baseline, 28 days post Dose 1 and 28 days post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.||titer||95% Confidence Interval|Geometric Mean
677421|NCT01609257|Secondary|Percentage of Participants With HBGA (PGM) - Anti-Norovirus GI.1 VLP Seroresponse From Baseline|Seroresponse was defined as a 4-Fold Rise from Baseline|Baseline to 28 days post Dose 1 and 28 days post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.||percentage of participants||95% Confidence Interval|Number
677422|NCT01609257|Secondary|HBGA (PGM) - Anti-Norovirus GI.1 VLP GMFR From Baseline|HBGA (PGM) is Histoblood Group Antigen (Pig Gastric Mucin).|Baseline to 28 days post Dose 1 and 28 days post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.||ratio||95% Confidence Interval|Geometric Mean
677423|NCT01609257|Secondary|ELISA IgA- Anti-Norovirus GII.4 cVLP GMT||Baseline, 28 days post Dose 1 and 28 days post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.||titer||95% Confidence Interval|Geometric Mean
677424|NCT01609257|Secondary|Percentage of Participant With ELISA IgA- Anti-Norovirus GII.4 cVLP Seroresponse From Baseline|Seroresponse was defined as a 4-Fold Rise from Baseline.|Baseline to 28 days post Dose 1 and 28 days post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.||percentage of participants||95% Confidence Interval|Number
677425|NCT01609257|Secondary|ELISA IgA- Anti-Norovirus GII.4 cVLP GMFR From Baseline||Baseline to 28 days post Dose 1 and 28 days post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.||ratio||95% Confidence Interval|Geometric Mean
677426|NCT01609257|Secondary|ELISA IgA- Anti-Norovirus GI.1 VLP Geometric Mean Titer (GMT)||Baseline, 28 days Post Dose 1 and 28 days Post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.||titer||95% Confidence Interval|Geometric Mean
677427|NCT01609257|Secondary|Percentage of Participants With ELISA IgA- Anti-Norovirus GI.1 VLP Seroresponse (4-fold Rise) From Baseline||Baseline to 28 days Post Dose 1 and 28 days Post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.||percentage of participants||95% Confidence Interval|Number
677428|NCT01609257|Secondary|ELISA Immunoglobulin A (IgA)- Anti-Norovirus GI.1 VLP Geometric Mean Fold Rise (GMFR) From Baseline||Baseline to 28 days Post Dose 1 and 28 days Post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.||ratio||95% Confidence Interval|Geometric Mean
677430|NCT01609257|Secondary|Percentage of Participants With Pan-Ig ELISA - Anti-Norovirus GII.4 cVLP Seroresponse From Baseline|Seroresponse was defined as a 4-Fold Rise from Baseline.|Baseline to 28 days post Dose 1 and 28 days post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.||percentage of participants||95% Confidence Interval|Number
677431|NCT01609257|Secondary|Pan-Ig ELISA - Anti-Norovirus GII.4 cVLP GMFR From Baseline||Baseline to 28 days post Dose 1 and 28 days post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.||ratio||95% Confidence Interval|Geometric Mean
677432|NCT01609257|Secondary|Pan-Ig ELISA - Anti-Norovirus GI.1 VLP Geometric Mean Titer (GMT)||Baseline, 28 days Post Dose 1 and 28 days Post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.||titer||95% Confidence Interval|Geometric Mean
677433|NCT01609257|Secondary|Percentage of Participants With Pan-Ig ELISA - Anti-Norovirus GI.1 VLP Seroresponse (4-fold Rise) From Baseline||Baseline, 28 days Post Dose 1 and 28 days Post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.||percentage of participants||95% Confidence Interval|Number
677434|NCT01609257|Secondary|Pan-Ig ELISA - Anti-Norovirus GI.1 VLP Geometric Mean Fold Rise (GMFR) From Baseline||Baseline to 28 days Post Dose 1 and 28 days Post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.||ratio||95% Confidence Interval|Geometric Mean
677435|NCT01609257|Other Pre-specified|Correlation of GII.4 Serum HGBA Antibodies Prior to Challenge Associated With Protection From GII.4 Infection|Percentage of placebo subjects HBGA seropositive pre-challenge by infection status.|Pre Challenge to Day 30 Post Challenge|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.||percentage of participants|||Number
677436|NCT01609257|Other Pre-specified|Correlation of GII.4 Serum HBGA Antibodies Prior to Challenge Associated With Protection From GII.4 Illness|Percentage of placebo subjects HBGA seropositive pre-challenge by illness status.|Pre Challenge to Day 30 Post Challenge|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.||percentage of participants|||Number
677437|NCT01609257|Secondary|Percentage of Participants With GII.4 Seroresponse Rate (4-fold Rise) From Pre-challenge Day 0 to Post-Challenge Day 30|Seroresponse was a 4-fold increase in IgG ELISA anti-GII.4 norovirus P particle antibody titer from pre-challenge to post-challenge.|Pre Challenge to 30 Days Post Challenge|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.||percentage of participants||95% Confidence Interval|Number
677438|NCT01609257|Secondary|Percentage of Participants With GII.4 Norovirus Positive RT-PCR in the Stool During the Inpatient and /or Outpatient Phase||Pre Challenge to 30 Days Post Challenge|Participants from the MITT population, all participants with at least one dose of study drug, challenge stage with data available for analysis.||percentage of participants|||Number
677439|NCT01609257|Secondary|Duration of Viral AGE Due to GII.4 Strain During the Inpatient Phase|Duration of symptoms was determined by a blinded committee review of each participant's symptoms.|Symptoms collected from Challenge dose (at least 28 days after dose 2) to discharge (at least 96 hours after challenge dose)|Participants from the MITT population, all participants who received at least one dose of study drug, challenge stage with Viral AGE.||hours||Full Range|Median
677440|NCT01609257|Secondary|Severity of Viral AGE Due to GII.4 Strain Assessed by Post-Challenge Symptom Collection During the Inpatient Phase|Score 1 was based on a subset of symptoms including: elevated oral temperature, myalgia, nausea, abdominal cramps, bloating, diarrhea, and vomiting. Score 2 was based on all Score 1 symptoms plus fatigue/malaise, chills, and loss of appetite. Total Score 1=0 to 20 and Total Score 2=0 to 29. Higher numbers are worse.|Symptoms collected from Challenge dose (at least 28 days after dose 2) to discharge (at least 96 hours after challenge dose)|Participants from the MITT population, all participants who received at least one dose of study drug, challenge stage with Viral AGE.||score on a scale||Standard Deviation|Mean
677441|NCT01609257|Secondary|Severity of Viral AGE Due to GII.4 Strain Assessed by Modified Vesikari Scoring System During the Inpatient Phase|Vesikari Scoring System assesses the following symptoms: duration of diarrhea (days), maximum number of diarrheal stools/24 hours, duration of vomiting (days), maximum number of vomiting episodes/24 hours, fever and dehydration. Since the typical inpatient phase was four days in length, the duration of diarrhea scoring was modified to fit this time frame. Modified Vesikari Scale Total Score=0 to 17. Higher numbers are worse.|Symptoms collected from Challenge dose (at least 28 days after dose 2) to discharge (at least 96 hours after challenge dose)|Participants from the MITT population, all participants who received at least one dose of study drug, challenge stage with Viral AGE.||score on a scale||Standard Deviation|Mean
677442|NCT01609257|Secondary|Percentage of Participants With 4-Fold Rise In Serum P-Particle Antibody Titer by ELISA or Detection of Norovirus GII.4 by RT-PCR in the Stool||Pre Challenge to 30 Days Post Challenge|MITT population included all participants who received at least one dose of study drug, Challenge stage.||percentage of participants|||Number
677443|NCT01609257|Primary|Percentage of Participants With Serious Adverse Events (SAEs) 365 Days Following the Last Study Vaccination|A SAE was any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.|365 Days Following Dose 2 (Up to 393 days)|MITT population included all participants who received at least one dose of study drug.||percentage of participants|||Number
677444|NCT01609257|Primary|Percentage of Participants Experiencing Solicited Systemic Adverse Events Within 7 Days Post-Dose 2|Systemic signs or symptoms included: elevated fever, headache, fatigue, muscle aches, chills, joint aches and gastrointestinal symptoms of nausea, vomiting, diarrhea, abdominal cramps/pain.|Within 7 days post-dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, who received a second dose.||percentage of particpants||95% Confidence Interval|Number
678210|NCT01600222|Primary|Change in 24-hour Urinary Calcium Excretion From Baseline to Day 28|The effect of LEO 90100 on calcium metabolism was evaluated based on change in 24-hour urinary calcium excretion from Baseline to Day 28 in 24-hour.|Baseline and Day 28|||mmol/24H||Standard Deviation|Mean
677445|NCT01609257|Primary|Percentage of Participants Experiencing Solicited Systemic Adverse Events Within 7 Days Post-Dose 1|Systemic signs or symptoms included: elevated daily oral temperature (fever), headache, fatigue, muscle aches, chills, joint aches and gastrointestinal symptoms of nausea, vomiting, diarrhea, abdominal cramps/pain.|Within 7 days post-dose 1|MITT included all participants who received at least one dose of study drug. Data is missing for 2 participants.||percentage of particpants||95% Confidence Interval|Number
677446|NCT01609257|Primary|Percentage of Participants Experiencing Solicited Local Adverse Events Within 7 Days Post-Dose 2|Local Adverse Events included local injection site reactions/symptoms: pain, tenderness, redness, and swelling.|Within 7 days post-dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, who received a second dose.||percentage of participants||95% Confidence Interval|Number
677447|NCT01609257|Primary|Percentage of Participants Experiencing Solicited Local Adverse Events Within 7 Days Post-Dose 1|Local Adverse Events included local injection site reactions/symptoms: pain, tenderness, redness, and swelling.|Within 7 days post-dose 1|MITT population included all participants who received at least one dose of study drug. Data is missing for 2 participants.||percentage of participants||95% Confidence Interval|Number
677448|NCT01609257|Primary|Percentage of Participants With Viral AGE Clinical Illness and Fecal Virus Excretion Detected by RT-PCR OR 4-Fold Rise In Anti-GII.4 Norovirus P Particle Antibody Titer|Viral AGE due to Norovirus GII.4 strain during the inpatient stay that meets clinical illness definition 1,2 or 3 and positive for infection as measured by fecal virus excretion detected by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) OR a 4-fold rise in Immunoglobulin G Enzyme-Linked Immunosorbent Assay (IgG ELISA) anti-GII.4 norovirus P particle antibody titer from pre-challenge (Within 2 weeks of Challenge Day 0) to post-challenge (Challenge Day 30). The clinical illness definitions are 1: diarrhea (defined as ≥ 3 loose or liquid stools OR >400-600 grams of loose or liquid stools produced in any 24-hour period), 2: vomiting (defined as ≥ 2 vomiting episodes in any 24-hour period) or 3. One Vomiting episode plus any loose or liquid stool in any 24-hour period OR one vomiting episode plus at least 2 of the following 5 events: nausea, fever ≥99.7°F orally, abdominal cramps or pains, abdominal gurgling or bloating, or myalgia in any 24-hour period.|Symptoms collected from Challenge dose (at least 28 days after dose 2) to discharge (at least 96 hours after challenge dose)|Modified intent-to-treat population (mITT) included all participants who received at least one dose of study drug, challenge stage.||percentage of participants|||Number
677449|NCT01609062|Secondary|Adolescent Pediatric Pain Tool (APPT) - Pain Intensity|"The APPT is a validated, multidimensional tool to evaluate pain in children, adolescents, and young adults. The complete APPT is measured in three parts - Part 1 of the APPT scale determines the subject's pain locations using a body template. Part 2 of the APPT scale determines the intensity of the pain using a 10 cm visual analog scale (VAS) with the lowest point of the scale (0) labeled No Pain and the highest point on the scale (10) labeled Worst Possible Pain. Intermediate regions of the sale were labeled with 3 intermediate descriptors (Little Pain, Medium Pain, and Large Pain). Part 3 of the APPT scale characterizes the pain by tracking the number and percentage of words selected by subjects to describe their pain from a total of 57 choices. Part 2 corresponds most closely to other typically used pain scales (based on VAS) and for this reason the results from Part 2 are presented here.
Change from baseline to Week 12, 24, and 52 in pain intensity."|Baseline, Week 12, 24, and 52|Modified Intent-to-treat||units on a scale||Standard Deviation|Mean
677450|NCT01609062|Secondary|Muscle Strength Testing (MST) - Elbow Flexion Test|Percent change from baseline to Week 25 and 52 as measured by the peak force in MST elbow flexion test (newton meters).|Baseline, Week 25 and 52|Modified Intent-to-treat Analysis Set||Percent Change||Standard Deviation|Mean
677451|NCT01609062|Secondary|Muscle Strength Testing (MST) - Knee Flexion Test|Percent change from baseline to Week 25 and 52 as measured by the peak force in MST knee flexion test (newton meters).|Baseline, Week 25 and 52|Modified Intent-to-treat Analysis Set||Percent Change||Standard Deviation|Mean
677452|NCT01609062|Secondary|Muscle Strength Testing (MST) - Knee Extension Test|Change from baseline to Week 25 and 52 as measured by the peak force in MST knee extension test (newton meters).|Baseline, Week 25 and 52|Modified Intent-to-treat Analysis Set||Percent Change||Standard Deviation|Mean
677453|NCT01609062|Secondary|Cardiopulmonary Exercise Testing (CPET) - Aerobic Efficiency|"Subjects performed maximal incremental exercise testing using an electronically braked upright cycle ergometer. Cycle ergometry is a method of CPET that may be feasible in subjects who have orthopedic, peripheral vascular, or neurological limitations that restrict weight bearing.
Percent change from baseline to Week 25 and 52 as measured by the CPET Aerobic Efficiency (ml/watt).
Note that decline in Aerobic Efficiency translate into an improvement"|Baseline, Week 25 and 52|A subset of mITT subjects who were scheduled to perform CPET||Percent Change||Standard Deviation|Mean
677454|NCT01609062|Secondary|Cardiopulmonary Exercise Testing (CPET) - O2 Pulse|"Subjects performed maximal incremental exercise testing using an electronically braked upright cycle ergometer. Cycle ergometry is a method of CPET that may be feasible in subjects who have orthopedic, peripheral vascular, or neurological limitations that restrict weight bearing.
Percent change from baseline to Week 25 and 52 as measured by the CPET O2 pulse (ml/beat)"|Baseline, Week 25 and 52|A subset of mITT subjects who were scheduled to perform CPET||Percent Change||Standard Deviation|Mean
677455|NCT01609062|Secondary|Cardiopulmonary Exercise Testing (CPET) - Peak Workload|"Subjects performed maximal incremental exercise testing using an electronically braked upright cycle ergometer. Cycle ergometry is a method of CPET that may be feasible in subjects who have orthopedic, peripheral vascular, or neurological limitations that restrict weight bearing.
Percent change from baseline to Week 25 and 52 as measured by the CPET Peak workload (watt)"|Baseline, Week 25 and 52|A subset of mITT subjects who were scheduled to perform CPET||Percent Change||Standard Deviation|Mean
677456|NCT01609062|Secondary|Cardiopulmonary Exercise Testing (CPET) - Duration of Exercise|"Subjects performed maximal incremental exercise testing using an electronically braked upright cycle ergometer. Cycle ergometry is a method of CPET that may be feasible in subjects who have orthopedic, peripheral vascular, or neurological limitations that restrict weight bearing.
Change from baseline to Week 25 and 52 as measured by the CPET Duration of Exercise (min)"|Baseline, Week 25 and 52|A subset of mITT subjects who were scheduled to perform CPET||Percent Change||Standard Deviation|Mean
677823|NCT01605292|Secondary|Time to Sheath Insertion (Seconds)|Time from initiation of vascular access attempts to successful aspiration or flushing of the sheath. Time for lidocaine administration, palpation of pulse, or imaging is excluded.|Immediately during procedure (within 30 minutes)|||seconds||Standard Deviation|Mean
677458|NCT01609062|Secondary|Respiratory Function Test (MVV and FVC)|"Respiratory Function was assessed by spirometry in accordance with American Thoracic Society standards.
Percent change from baseline to Week 12, 24, and 52 as measured by Maximum Voluntary Ventilation (MVV, L/min) Percent change from baseline to Week 12, 24, and 52 as measured by Forced Vital Capacity (FVC, L)"|Baseline, Week 12, 24, and 52|Modified Intent-to-treat Analysis Set||Percent Change||Standard Deviation|Mean
677459|NCT01609062|Secondary|3-minute Stair Climb Test (3MSCT)|Change from baseline to Week 12, 24, and 52 as measured in speed (stairs/min) in 3MSCT.|Baseline, Week 12, 24, and 52|Modified Intent-to-Treat Analysis Set||stairs/min||Standard Deviation|Mean
677460|NCT01609062|Secondary|6-minute Walk Test (6MWT)|Change from baseline to Week 12, 24, and 52 as measured in distance walked (meters) in 6MWT.|Baseline, Week 12, 24, and 52|Modified Intent-to-Treat Analysis Set||meters||Standard Deviation|Mean
677461|NCT01609062|Primary|Safety Evaluation|"The primary objective of the study is to evaluate the safety of weekly infusions of BMN 110; the safety variables included Adverse Events (AEs).
The primary outcome measure data is presented in more detail under the Adverse Events section."|Entire Study Period, up to 192 weeks or ETV (early termination visit)|The primary outcome measure data is presented in more detail under the Adverse Events section.||participants|||Number
677462|NCT01609023|Secondary|Time to Progression (TTP) Assessed Using Local Standards|TTP is defined as the time from enrollment to the PD. PD was defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Kaplan-Meier estimate was used for analysis.|From enrollment until disease progression or death, assessed up to 26 months|ITT population||months||95% Confidence Interval|Mean
677463|NCT01609023|Secondary|Percentage of Participants With PR Assessed Using Local Standards|Percentage of participants with PR as determined by the investigator was reported. PR was defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.|Months 6, 12, 18, and 24|ITT population. Here, ‘Number of Participants Analyzed’ = overall number of participants who were evaluable for this outcome. ‘n’ = participants who were evaluable for specified timepoints.||percentage of participants|||Number
677464|NCT01609023|Secondary|Percentage of Participants With CR Assessed Using Local Standards|Percentage of participants with CR as determined by the investigator was reported. CR was defined as disappearance of all target lesions.|Months 6, 12, 18, and 24|ITT population. Here, ‘Number of Participants Analyzed’ = overall number of participants who were evaluable for this outcome. ‘n’ = participants who were evaluable for specified timepoints.||percentage of participants|||Number
677465|NCT01609023|Secondary|Percentage of Participants With Objective Response of Complete Response (CR) or Partial Response (PR) Assessed Using Local Standards|Percentage of participants with CR or PR as determined by the investigator was reported. CR was defined as disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.|Months 6, 12, 18, and 24|ITT population. Here, ‘Number of Participants Analyzed’ = overall number of participants who were evaluable for this outcome. ‘n’ = participants who were evaluable for specified timepoints.||percentage of participants|||Number
677466|NCT01609023|Secondary|Percentage of Participants With Disease Progression or Death Assessed Using Local Standards|PD was defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Months 6, 12, 18, and 24|ITT population. Here, ‘Number of Participants Analyzed’ = overall number of participants who were evaluable for this outcome. ‘n’ = participants who were evaluable for specified timepoints.||percentage of participants|||Number
677467|NCT01609023|Secondary|Progression-Free Survival (PFS) Assessed Using Local Standards|PFS was defined as the time from enrollment to the first documented progression of disease or death due to any cause. Progressive disease (PD) was defined as at least a 20 percent (%) increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. KaplanMeier estimate was used for analysis.|From enrollment until disease progression or death, assessed up to 24 months|ITT population||months||95% Confidence Interval|Median
677468|NCT01609023|Primary|Percentage of Participants With Adverse Events (AEs)|An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|Baseline up to 24 months|Safety population included all eligible participants.||percentage of participants|||Number
677469|NCT01609010|Secondary|Overall Survival|The median time, in months, from randomization to OS event assessed using Kaplan-Meier estimates. One month=30.4 days|BL, Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period|ITT population||months||Full Range|Median
677470|NCT01609010|Secondary|Overall Survival (OS) - Percentage of Participants With an Event|An overall survival event was defined as death due to any cause.|BL, Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period|ITT population||percentage of participants|||Number
677471|NCT01609010|Secondary|Time to Disease Progression|The median time, in months, from randomization to disease progression event assessed using Kaplan-Meier estimates. One month=30.4 days|BL, Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period|ITT population||months||95% Confidence Interval|Median
677472|NCT01609010|Secondary|Disease Progression - Percentage of Participants With an Event|A disease progression event was defined as tumor progression or death due to any cause (or a censored observation).|BL, Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period|ITT population||percentage of participants|||Number
677473|NCT01609010|Secondary|Duration of Response|The median time, in months, from the date of the first observation of CR, CRu, or PR and the date of progressive disease (PD), censored observation, or death due to any cause. PD was defined as an increase of >50% compared to BL in the sum of the product of the two largest perpendicular parameters of measurable lymphoma, or the occurrence of new lesions. One month=30.4 days. Response duration was calculated amongst responders (CR+CRu+PR) with cutoffs for follow-up applied.|BL, Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period|ITT population; n=number of participants assessed for the specified parameter at a given visit. Only participants with a response (CR+CRu+PR, CR+CRu, or CR only) were included in the analysis.||months||95% Confidence Interval|Median
677474|NCT01609010|Secondary|Duration of Response - Percentage of Participants With an Event|Response duration was defined as the period between the date for first observation of CR, CRu or PR and the date of progressive disease (PD), censored observation or death of any cause. Response duration was also assessed for response defined as CR only. Response duration was calculated among responders (CR+CRu+PR) with cutoffs for follow-up applied.|BL, Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period|ITT population||percentage of participants|||Number
677475|NCT01609010|Secondary|Percentage of Participants Achieving CR or CRu|CR was defined as the complete disappearance of all previously detectable disease signs; the absence of palpable lymph nodes >1 cm or nodes >1.5 cm observed in CATscan; and negative bone marrow pathology, if initially positive. CRu was defined as CR, except that bone marrow results were indeterminate.|Weeks 10 and 16|ITT population; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants||95% Confidence Interval|Number
677476|NCT01609010|Secondary|Percentage of Participants Achieving Complete Response (CR), Unconfirmed CR (CRu), or Partial Response (PR)|CR was defined as the complete disappearance of all previously detectable disease signs; the absence of palpable lymph nodes greater than (>) 1 centimeter (cm) or nodes >1.5 cm observed in computerized axial tomography (CAT) scan; and negative bone marrow pathology, if initially positive. CRu was defined as CR, except that bone marrow results were indeterminate. PR was defined as a decrease of greater than or equal to (≥) 50 percent (%) compared with the BL value in the sum of the products of the two largest perpendicular diameters in all measurable and evaluable lesions; and a ≥50% reduction of the size from BL if hepato-splenomegaly was present.|Weeks 10 and 16|ITT population; number (n) equals (=) number of participants assessed for the specified parameter at a given visit.||percentage of participants||95% Confidence Interval|Number
677477|NCT01609010|Primary|Treatment Failure - Time to Event|The median time, in months, between randomization and treatment failure event determined using Kaplan-Meier estimates.|BL, Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period|ITT population||months||95% Confidence Interval|Median
677478|NCT01609010|Primary|Treatment Failure - Percentage of Participants With an Event|Treatment failure was defined as an event of any of the following: progressive disease while receiving study treatment, death due to any cause, or the initiation of another type of treatment due to stable disease, progressive disease or relapse, or intolerance to study treatment.|Baseline (BL), Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period|ITT population||percentage of participants|||Number
677479|NCT01608971|Primary|Rotem MCF Fibtem and MCF Intem|The following parameters of the INTEM test will be analyzed: MCF [mm] (maximum clot firmness) which correlates with the platelet count. Furthermore, the MCF [mm] of the FIBTEM test will be analyzed, which correlates with the fibrinogen concentration.|15 Minutes after protamine infusion|Patients of both groups||mm||Inter-Quartile Range|Median
677480|NCT01608971|Secondary|12 h Postoperative Blood Loss|The intra and postoperative blood loss from the time point of protamine administration until 12 hours postoperatively will be analyzed.|15 min after protamine administration until 12 hours postoperatively|||ml/12 hour||Inter-Quartile Range|Median
677481|NCT01608971|Secondary|Transfusion of Blood Products and Coagulation Factors|The transfusion of blood products and coagulation factors will be assesed from protamine administration until 12 hours postoperatively .|From protamine administration until 12 h after surgery|Transfusion of RBC||percentage of patients transfused|||Number
677482|NCT01608971|Primary|INTEM HEPTEM and FIBTEM Test of the ROTEM Coagulation Analyzer|The Intem test of the ROTEM analyzer evaluates the response of the heamostatic system to activation of the intrinsic coagulation system. The following parameters of the INTEM test will be analyzed. CT [seconds](coagulation time), CFT [seconds] (clot formation time) and the CT [seconds] of the HEPTEM test which is non sensitive for residual heparine.|Tests will be measured 15 minutes after Protamine infusion|Rotem INTEM CT, CFT, MCF and FIBTEM MCF and Heptem CT||seconds||Inter-Quartile Range|Median
677483|NCT01608815|Secondary|Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Following Vaccination With A Typhoid Vi Polysaccharide Vaccine|Solicited injection site: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia. Grade 3 injection site (children): Pain Incapacitating, unable to perform usual activities; Erythema and Swelling ≥ 50 mm; Grade 3 injection site (adults and adolescents): Pain, Significant, prevents daily activity; Erythema and Swelling, >100 mm. Grade 3 systemic reactions: Fever, ≥39˚C; Headache, Malaise, and Myalgia, Significant, prevents daily activity.|Day 0 up to Day 7 post-vaccination|Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set.||Participants|||Number
677484|NCT01608815|Secondary|Geometric Mean Titer Ratios (GMTRs) of Antibodies to Vi Antibody Following Vaccination With A Typhoid Vi Polysaccharide Vaccine|Anti-Vi antibodies were measured by enzyme-linked immunosorbent assay (ELISA).|Day 28 post-vaccination|Geometric Mean Titer Ratios were assessed in the Immunology Analysis Set.||Ratio||95% Confidence Interval|Geometric Mean
677485|NCT01608815|Secondary|Geometric Mean Titers (GMTs) of Antibodies to Vi Antibody Before and Following Vaccination With A Typhoid Vi Polysaccharide Vaccine|Anti-Vi antibodies were measured by enzyme-linked immunosorbent assay (ELISA)|Day 0 (pre-vaccination) and Day 28 post-vaccination|Geometric Mean Titers were assessed in the Immunology Analysis Set.||Titers||95% Confidence Interval|Geometric Mean
677486|NCT01608815|Primary|Number of Participants With At Least a 4-Fold Rise in Vi Antibody Titers Following Vaccination With a Typhoid Vi Polysaccharide Vaccine|Anti Vi antibodies were measured by Enzyme-Linked ImmunoSorbent Assay (ELISA).|Day 0 (pre-vaccination) to Day 28 (post-vaccination)|Vi antibody titers were assessed in the Immunology Analysis Set.||Participants|||Number
677487|NCT01608724|Secondary|Change From Baseline in 2-hour Postprandial Plasma Glucose (2h-PPG)||Week 24|Patients who participated in standard noodle test in the per-protocoal analysis set (PPS), which included patients who took at least 1 dose of study drug, had baseline and post-baseline efficacy records, and had no major protocol deviations.||mmol/L||Standard Error|Mean
677488|NCT01608724|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)||Weeks 6, 12, 18, and 24|Per-protocoal analysis set (PPS), including patients who took at least 1 dose of study drug, had baseline and post-baseline efficacy records, and had no major protocol deviations.||mmol/L||Standard Error|Mean
677489|NCT01608724|Secondary|Proportion (%) of Patients Achieving HbA1c <7%||Weeks 6, 12, and 24|Per-protocoal analysis set (PPS), including patients who took at least 1 dose of study drug, had baseline and post-baseline efficacy records, and had no major protocol deviations.||Percentage|||Number
677490|NCT01608724|Primary|Absolute Change From Baseline in Haemoglobin A1c (HbA1c)|Evaluation after 24 weeks oral administration of saxagliptin treatment in patients with type 2 diabetes inadequately controlled with diet and exercise or with metformin in addition to diet and exercise.|Weeks 6, 12, and 24|Per-protocoal analysis set (PPS), including patients who took at least 1 dose of study drug, had baseline and post-baseline efficacy records, and had no major protocol deviations.||(%)||Standard Error|Mean
677491|NCT01608672|Secondary|Percentage of Participants Where Physician Was Mostly or Very Satisfied With Effectiveness of ≥ 5 Years BOTOX® Treatments Using the Physician Questionnaire|"Physicians rated their overall satisfaction with BOTOX® treatment by answering the question on the Physician Reported Overall Satisfaction of Effectiveness Questionnaire: You have treated this patient with BOTOX® facial aesthetic treatment(s) for at least 5 years. How satisfied overall are you with the effect of BOTOX®? using the following possible answers: Very Dissatisfied, Mostly Dissatisfied, Neither Satisfied or Dissatisfied, Mostly Satisfied or Very Satisfied. The percentage of participants where the physician answered Mostly Satisfied or Very Satisfied is reported."|Study Day 1 (approximately 4-28 weeks following last treatment)|Per Protocol population included all enrolled participants who met eligibility criteria with data available for analysis.||Percentage of participants|||Number
677492|NCT01608672|Secondary|Percentage of Participants Mostly or Very Satisfied With Effectiveness of ≥ 5 Years BOTOX® Treatments Using the Patient Questionnaire|"Participants rated their overall satisfaction with BOTOX® treatment by answering the question on the Patient Reported Overall Satisfaction of Effectiveness Questionnaire: You have received BOTOX® facial aesthetic treatment(s) for at least 5 years. How satisfied overall are you with the effect of BOTOX®? using the following possible answers: Very Dissatisfied, Mostly Dissatisfied, Neither Satisfied or Dissatisfied, Mostly Satisfied or Very Satisfied. The percentage of participants who answered Mostly Satisfied or Very Satisfied is reported."|Study Day 1 (approximately 4-28 weeks following last treatment)|Per Protocol population included all enrolled participants who met eligibility criteria with data available for analysis.||Percentage of participants|||Number
677493|NCT01608672|Primary|Percentage of Participants Mostly or Very Satisfied With Their Glabellar Lines on the Facial Line Satisfaction Questionnaire (FLSQ)|Participants assessed their overall satisfaction with their glabellar lines by answering FLSQ Question 5: “How satisfied are you with the effect your treatment had on your facial lines?” using a 5-point scale where: -2=very dissatisfied, -1=mostly dissatisfied, 0=neither dissatisfied nor satisfied, 1=mostly satisfied and 2=very satisfied. The percentage of participants mostly or very satisfied is reported.|Study Day 1 (approximately 4-28 weeks following last treatment)|Per Protocol population included all enrolled participants who met eligibility criteria with data available for analysis.||Percentage of participants|||Number
677494|NCT01608659|Secondary|Percent of Subjects Reporting Satisfaction With Treatment Effects|Percent of subjects reporting satisfaction with treatment effects per chart notes.|24 Months|All subjects enrolled in the study who were evaluated for this data point. N equals the number of subjects evaluated in each treatment period.||Percentage of Subjects||Standard Deviation|Mean
677495|NCT01608659|Secondary|Inter-Injection Interval Duration of Each Treatment Period|Inter-injection interval duration of each treatment period. Duration is defined as the number of days of an injection cycle.|24 Months|All subjects enrolled in the study who were evaluated for this data point. N equals the number of subjects evaluated in each treatment period.||Days||Full Range|Median
677496|NCT01608659|Primary|Average Total Dose Per Treatment Period|Average total dose per treatment period was defined as total treatment dose plus total touch-up dose plus total follow-up dose.|24 Months|All subjects enrolled in the study who were evaluated for this data point. N equals the number of subjects evaluated in each treatment period.||Units||Standard Deviation|Mean
677497|NCT01608490|Secondary|Mean Percent Change in FEV1|Mean percent change in FEV1 at 12 months|BL to 12 months|||percentage change||Standard Error|Mean
677498|NCT01608490|Primary|Meters: 6 Minute Walk Test|mean absolute change from baseline at 12 months in the 6 Minute Walk Test comparing test and control groups|baseline through 12 months follow up|Patients who were analyzed at 12 months.||meters||Standard Error|Mean
677499|NCT01608321|Primary|Change in the Brief Pain Inventory (Short Form) Score|The Brief Pain Inventory (BPI) is one of the most widely used measurement tools for assessing clinical pain. The BPI allows patients to rate the severity of their pain and the degree to which their pain interferes with common dimensions of feeling and function. The basic pain scale rating is a rating of 0-10 with 0 as no pain, and 10 the worst pain imaginable.|Comparison of baseline BPI and end-of-treatment BPI (time 3-4 weeks)|One patient did not meet study entry criteria at baseline (pain scale score = 0), so was not included in the analysis||units on a scale||Standard Deviation|Mean
677500|NCT01608308|Secondary|Postoperative Vital Sign (Respiratory Rate)|Postoperative vital signs (systolic and diastolic blood pressure, pulse, temperature, and respiratory rate) were measured at different time points up to 4 hours after surgery.|During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)|||breaths per minute||Standard Deviation|Mean
677501|NCT01608308|Secondary|Postoperative Vital Sign (Temperature)|Postoperative vital signs (systolic and diastolic blood pressure, pulse, temperature, and respiratory rate) were measured at different time points up to 4 hours after surgery.|During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)|||Fahrenheit||Standard Deviation|Mean
677502|NCT01608308|Secondary|Postoperative Vital Sign (Pulse)|Postoperative vital signs (systolic and diastolic blood pressure, pulse, temperature, and respiratory rate) were measured at different time points up to 4 hours after surgery.|During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)|||beats per minute||Standard Deviation|Mean
677503|NCT01608308|Secondary|Postoperative Vital Sign (Diastolic Blood Pressure)|Postoperative vital signs (systolic and diastolic blood pressure, pulse, temperature, and respiratory rate) were measured at different time points up to 4 hours after surgery.|During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)|||mmHg||Standard Deviation|Mean
677504|NCT01608308|Secondary|Postoperative Vital Sign (Systolic Blood Pressure)|Postoperative vital signs (systolic and diastolic blood pressure, pulse, temperature, and respiratory rate) were measured at different time points up to 4 hours after surgery.|During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)|||mmHg||Standard Deviation|Mean
678211|NCT01600222|Primary|Change in Albumin-corrected Serum Calcium From Baseline to Day 28|The effect of LEO 90100 on calcium metabolism was evaluated based on change in albumin-corrected serum calcium from Baseline to Day 28.|Baseline and Day 28|||mmol/L||Standard Deviation|Mean
677506|NCT01608308|Secondary|Number of Participants Who Received Intraoperative Supplemental Fentanyl|Number of participants who received intraoperative supplemental fentanyl. The decision to administer fentanyl is based on hemodynamic changes, such as increasing blood pressure and heart rate.|During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)|||participants|||Number
677507|NCT01608308|Secondary|Total Doses of Postoperative Opiate (Morphine) Use|The total amount of morphine utilized in Postoperative Acute Care Unit (PACU) will be recorded. One dose is a 1mg bolus of morphine.|During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)|||doses||Inter-Quartile Range|Median
677508|NCT01608308|Primary|Pain Level Assessed Using a Visual Analogue Scale (VAS) Scale|VAS is a validated, self-reported data sheet assessing average pain intensity. Possible scores range from 0 (no pain) to 10 (highest level of pain).|15 minutes and 120 minutes Post-Operatively|At the 15 minute time point, data was obtained for 24 participants in the acetaminophen group and 26 participants in the control group. For the 120 minute time point, data was obtained for 7 participants in the acetaminophen group and 11 participants in the control group.||units on a scale||Inter-Quartile Range|Median
677509|NCT01608295|Secondary|Inflammatory Biomarkers|Blood Tests|Baseline and Final Visit||||||
677510|NCT01608295|Secondary|Neurocognitive Measures|A battery of neuropsychological tests|Baseline and Final Visit|||units on a scale||Standard Deviation|Mean
677511|NCT01608295|Secondary|UKU Side-effect Profile|Number of side-effect events per participant for the duration of the study.|Each visit for 12 weeks|||participants|||Number
677512|NCT01608295|Primary|Hamilton Depression Rating Scale (HDRS)|The HAMD measures the severity of depressive symptoms in participants with major depressive disorder (MDD). It is a checklist of 17 items that are ranked on a scale of 0-4 or 0-2. The range for the total score (which is the sum of the scores of all 17 items) is 0-52; a higher score indicates greater severity of symptoms.|Baseline and 12 weeks|||units on a scale||Standard Deviation|Mean
677513|NCT01608100|Primary|Clinical Performance- Positive Predictive Value (PPV)|The ARCHITECT STAT High Sensitive Troponin-I assay clinical performance was evaluated by calculating the Positive Predictive Value. The ARCHITECT STAT High Sensitive Troponin-I assay results were generated from subject's specimens collected at three collection time points in three tube types (K2 EDTA, Lithium Heparin Separator and Serum Separator).|Troponin value from three collection time points (0-2 hours, >2 and up to 4 hours, >4 hours and up to 9 hours) from subject presentation to the emergency department.|The number of subjects for analysis was determined by the number of subjects with at least one collection time point in the respective tube type (K2 EDTA, Lithium Heparin Separator, Serum Separator). Not all time points or collection tube types were able to be collected for all subjects.||%MI,TnI >cutoff vs all TnI > cutoff||95% Confidence Interval|Number
677514|NCT01608100|Primary|Clinical Performance- Negative Predictive Value (NPV)|The ARCHITECT STAT High Sensitive Troponin-I assay clinical performance was evaluated by calculating Negative Predictive Value. The ARCHITECT STAT High Sensitive Troponin-I assay results were generated from subject's specimens collected at three collection time points in three tube types (K2 EDTA, Lithium Heparin Separator and Serum Separator).|Troponin value from three collection time points (0-2 hours, >2 and up to 4 hours, >4 hours and up to 9 hours) from subject presentation to the emergency department.|The number of subjects for analysis was determined by the number of subjects with at least one collection time point in the respective tube type (K2 EDTA, Lithium Heparin Separator, Serum Separator). Not all time points or collection tube types were able to be collected for all subjects.||%nonMI,TnI</=cutoff vs all TnI</=cutoff||95% Confidence Interval|Number
677515|NCT01608100|Primary|Clinical Performance- Specificity|The ARCHITECT STAT High Sensitive Troponin-I assay clinical performance was evaluated by calculating Specificity. The ARCHITECT STAT High Sensitive Troponin-I assay results were generated from subject's specimens collected at three collection time points in three tube types (K2 EDTA, Lithium Heparin Separator and Serum Separator).|Troponin value from three collection time points (0-2 hours, >2 and up to 4 hours, >4 hours and up to 9 hours) from subject presentation to the emergency department.|The number of subjects for analysis was determined by the number of subjects with at least one collection time point in the respective tube type (K2 EDTA, Lithium Heparin Separator, Serum Separator). Not all time points or collection tube types were able to be collected for all subjects.||% nonMI with TnI </= cutoff vs all nonMI||95% Confidence Interval|Number
677516|NCT01608100|Primary|Clinical Performance- Sensitivity|The ARCHITECT STAT High Sensitive Troponin-I assay clinical performance was evaluated by calculating Sensitivity. The ARCHITECT STAT High Sensitive Troponin-I assay results were generated from subject's specimens collected at three collection time points in three tube types (K2 EDTA, Lithium Heparin Separator and Serum Separator).|Troponin value from three collection time points (0-2 hours, >2 and up to 4 hours, >4 hours and up to 9 hours) from subject presentation to the emergency department|The number of subjects for analysis was determined by the number of subjects with at least one collection time point in the respective tube type (K2 EDTA, Lithium Heparin Separator, Serum Separator). Not all time points or collection tube types were able to be collected for all subjects.||percentage MI withTnI >cutoff vs all MI||95% Confidence Interval|Number
677517|NCT01608100|Secondary|Prognosis|Specimens were collected at 11 EDs from 1,101 subjects presenting to the ED with symptoms consistent with ACS. All subject diagnoses were adjudicated by three board certified cardiologists according to current standard of care. ARCHITECT STAT High Sensitive Troponin I results were generated from subject specimens and evaluated for use as an aid in the assessment of prognosis. Analyses used the first available troponin result from multiple serial draw time points. Subjects were assessed for risk of all cause mortality (ACM) and major adverse cardiac event (MACE) at 30 day and 90 day time points after ED discharge. MACE consisted of myocardial infarction, urgent revascularization, and cardiac death. Subjects were followed-up for subsequent events by medical record review and/or subject/caregiver contact. Any ACM and MACE that occurred during the ED visit and on the same day as ED discharge were not included in the analyses.|30-day and 90-day follow-up|30 Day and 90-day prognosis (Kaplan Meier analysis) and Hazard ratios (Cox regression) for the overall 99th percentile cutoff (26.2 pg/mL) are summarized. *Censored is defined as the subject has not experienced ACM/MACE at the indicated follow-up time point.||participants|||Number
677541|NCT01607853|Secondary|Change in Total Clinical Score at Day 11 Compared to Baseline|Investigator’s rating of the clinical appearance of a psoriatic lesion. Maximum score is 9 (most severe); minimum score is 0 (least severe). The single items erythema, scaling, and infiltration (maximum score 3 each) are summed to obtain the Total Clinical Score.|Baseline to day 11|||units on a scale||Standard Deviation|Mean
677518|NCT01608100|Primary|Clinical Performance - Area Under the Curve|The ARCHITECT STAT High Sensitive Troponin-I assay clinical performance was evaluated by calculating the Area Under the Curve (AUC). The Area Under the Curve that was assessed, is used to determine the optimum clinical sensitivity and specificity for the ARCHITECT STAT High Sensitive Troponin-I assay. The ARCHITECT STAT High Sensitive Troponin-I assay results were generated from subject's specimens collected at three collection time points in three tube types (K2 EDTA, Lithium Heparin Separator and Serum Separator).|Troponin value from three collection time points (0-2 hours, >2 and up to 4 hours, >4 hours and up to 9 hours) from subject presentation to the emergency department|The number of subjects for analysis was determined by the number of subjects with at least one collection time point in the respective tube type (K2 EDTA, Lithium Heparin Separator, Serum Separator). Not all time points or collection tube types were able to be collected for all subjects.||Probability||95% Confidence Interval|Number
677519|NCT01607853|Secondary|Change in Skin Thickness - Echo-poor Band - Measured by Ultrasound From Baseline to Day 22||Baseline to day 22|||millimeters||Standard Deviation|Mean
677520|NCT01607853|Secondary|Change in Lesion Thickness Measured by Ultrasound From Baseline to Day 22.||Baseline to day 22|||millimeters||Standard Deviation|Mean
677521|NCT01607853|Secondary|Change From Baseline in Scaling at Day 22|Investigator’s rating of the clinical appearance of scaling. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 22|||units on a scale||Standard Deviation|Mean
677522|NCT01607853|Secondary|Change From Baseline in Scaling at Day 18|Investigator’s rating of the clinical appearance of scaling. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 18|||units on a scale||Standard Deviation|Mean
677523|NCT01607853|Secondary|Change From Baseline in Scaling at Day 15|Investigator’s rating of the clinical appearance of scaling. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 15|||units on a scale||Standard Deviation|Mean
677524|NCT01607853|Secondary|Change From Baseline in Scaling at Day 11|Investigator’s rating of the clinical appearance of scaling. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 11|||units on a scale||Standard Deviation|Mean
677525|NCT01607853|Secondary|Change From Baseline in Scaling at Day 8|Investigator’s rating of the clinical appearance of scaling. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 8|||units on a scale||Standard Deviation|Mean
677526|NCT01607853|Secondary|Change From Baseline in Scaling at Day 4|Investigator’s rating of the clinical appearance of scaling. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 4|||units on a scale||Standard Deviation|Mean
677527|NCT01607853|Secondary|Change From Baseline in Infiltration at Day 22|Investigator’s rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 22|||units on a scale||Standard Deviation|Mean
677528|NCT01607853|Secondary|Change From Baseline in Infiltration at Day 18|Investigator’s rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 18|||units on a scale||Standard Deviation|Mean
677529|NCT01607853|Secondary|Change From Baseline in Infiltration at Day 15|Investigator’s rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 15|||units on a scale||Standard Deviation|Mean
677530|NCT01607853|Secondary|Change From Baseline in Infiltration at Day 11|Investigator’s rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 11|||units on a scale||Standard Deviation|Mean
677531|NCT01607853|Secondary|Change From Baseline in Infiltration at Day 8|Investigator’s rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 8|||units on a scale||Standard Deviation|Mean
677532|NCT01607853|Secondary|Change From Baseline in Infiltration at Day 4|Investigator’s rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 4|||units on a scale||Standard Deviation|Mean
677533|NCT01607853|Secondary|Change From Baseline in Erythema at Day 22|Investigator’s rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 22|||units on a scale||Standard Deviation|Mean
677534|NCT01607853|Secondary|Change From Baseline in Erythema at Day 18|Investigator’s rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 18|||units on a scale||Standard Deviation|Mean
677535|NCT01607853|Secondary|Change From Baseline in Erythema at Day 15|Investigator’s rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 15|||units on a scale||Standard Deviation|Mean
677536|NCT01607853|Secondary|Change From Baseline in Erythema at Day 11|Investigator’s rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 11|||units on a scale||Standard Deviation|Mean
677537|NCT01607853|Secondary|Change From Baseline in Erythema at Day 8.|Investigator’s rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 8|||units on a scale||Standard Deviation|Mean
677538|NCT01607853|Secondary|Change From Baseline in Erythema at Day 4.|Investigator’s rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 4|||units on a scale||Standard Deviation|Mean
677539|NCT01607853|Secondary|Change in Total Clinical Score at Day 18 Compared to Baseline|Investigator’s rating of the clinical appearance of a psoriatic lesion. Maximum score is 9 (most severe); minimum score is 0 (least severe). The single items erythema, scaling, and infiltration (maximum score 3 each) are summed to obtain the Total Clinical Score.|Baseline to day 18|||units on a scale||Standard Deviation|Mean
677540|NCT01607853|Secondary|Change in Total Clinical Score at Day 15 Compared to Baseline|Investigator’s rating of the clinical appearance of a psoriatic lesion. Maximum score is 9 (most severe); minimum score is 0 (least severe). The single items erythema, scaling, and infiltration (maximum score 3 each) are summed to obtain the Total Clinial Score.|Baseline to day 15|||units on a scale||Standard Deviation|Mean
678169|NCT01600482|Secondary|Time to Ambulation|Time to Ambulation (TTA) is defined as the time elapsed between sheath removal and time when the patient stands and walk 6m (20ft) without re-bleeding.|With in the first 30 days +/- 7 days following the procedure|62 patients did not have TTA recorded.||minutes||Standard Deviation|Mean
677542|NCT01607853|Secondary|Change in Total Clinical Score at Day 8 Compared to Baseline|Investigator’s rating of the clinical appearance of a psoriatic lesion. Maximum score is 9 (most severe); minimum score is 0 (least severe). The single items erythema, scaling, and infiltration (maximum score 3 each) are summed to obtain the Total Clinical Score.|Baseline to day 8|||units on a scale||Standard Deviation|Mean
677543|NCT01607853|Secondary|Change in Total Clinical Score at Day 4 Compared to Baseline|Investigator’s rating of the clinical appearance of a psoriatic lesion. Maximum score is 9 (most severe); minimum score is 0 (least severe). The single items erythema, scaling, and infiltration (maximum score 3 each) are summed to obtain the Total Clinical Score.|Baseline to day 4|||units on a scale||Standard Deviation|Mean
677544|NCT01607853|Primary|Change in Total Clinical Score From Baseline to Day 22|Investigator’s rating of the clinical appearance of a psoriatic lesion. Maximum score is 9 (most severe); minimum score is 0 (least severe). The single items erythema, scaling, and infiltration (maximum score 3 each) are summed to obtain the Total Clincal Score|baseline to day 22|||units on a scale||Standard Deviation|Mean
677545|NCT01607645|Secondary|Duration of Thrombocytopenia Defined as Platelet Count Less Than 100,000||Assessed for up to 5 years|No member of Arm II was eligible for evaluation for this Outcome Measure. Therefore, no data was collected for Arm II.||days||Full Range|Mean
677546|NCT01607645|Secondary|Duration of Moderate Neutropenia Defined as an ANC Less Than 1000||Assessed for up to 5 years|No member of Arm II was eligible for evaluation for this Outcome Measure. Therefore, no data was collected for Arm II.||days||Full Range|Mean
677547|NCT01607645|Secondary|Duration of Severe Neutropenia Defined as an ANC Less Than 500||Assessed for up to 5 years|No member of Arm II was eligible for evaluation for this Outcome Measure. Therefore, no data was collected for Arm II.||days||Full Range|Mean
677548|NCT01607645|Secondary|Severe Prolonged Aplasia||Assessed for up to 45 days|||Participants|||Count of Participants
677549|NCT01607645|Secondary|Frequency and Severity of Grade 3, 4, and 5 Toxicities With Each Course of Decitabine-priming, Idarubicin, and Cytarabine According to NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 4.0||Assessed for up to 3 months after completion study treatment|We have analyzed 4 and 3 patients in each arm, respectively. One patient in each of the arms completed 2 cycles of therapy. The numbers provided in the Outcome Measure Data Table in Frequency and Severity of Grade 3, 4, and 5 Toxicities are the numbers of patients with each specified event.||Participants|||Count of Participants
677550|NCT01607645|Secondary|TRM With Each Course of Decitabine-priming, Idarubicin, and Cytarabine||Assessed for up to Day 30|||Participants|||Count of Participants
677551|NCT01607645|Secondary|CRiMRD+ Defined as Meeting All Criteria for a CRi But With Evidence of Minimal Residual Disease by Flow Cytometry, Cytogenetics, or Other Known Molecular Biomarkers||Assessed for up to 5 years|||Participants|||Count of Participants
677552|NCT01607645|Secondary|CRMRD+ Defined as a Morphologic CR But With Minimal Residual Disease by Flow Cytometry, Cytogenetics, or Other Known Molecular Biomarkers||Assessed for up to 5 years|||Participants|||Count of Participants
677553|NCT01607645|Secondary|CRi Defined as Meeting All Criteria for a Morphologic CR But ANC Remains Less Than 1,000/μL and/or Platelet Count Less Than 100,000/μL||Assessed for up to 5 years|||Participants|||Count of Participants
677554|NCT01607645|Secondary|CRMRD- Defined as Morphologic CR Without Evidence of Minimal Residual Disease by Flow Cytometry, Cytogenetics, or Other Known Molecular Biomarkers||Assessed for up to 5 years|||Participants|||Count of Participants
677555|NCT01607645|Secondary|Cytogenetic Response Defined as no Detectable Cytogenetic Abnormality in a Subsequent BM Specimen After Induction or Re-induction||Assessed for up to 5 years|||Participants|||Count of Participants
677556|NCT01607645|Secondary|Resistant Disease Defined as Patient Survives at Least 14 Days After Completion of the Last Dose of Induction or Re-induction But Has Persistent Leukemia in Peripheral Blood (PB) or BM||Assessed for up to 90 days|||Participants|||Count of Participants
677557|NCT01607645|Primary|Number of Participants Who Achieved Morphologic CR|Morphologic complete remission (CR): Absolute Neutrophil Count (ANC)≥1,000/uL, platelet count ≥100,000/uL, <5% Bone Marrow (BM) blasts, no Auer rods (cytoplasmic inclusions which result from an abnormal fusion of the primary (azurophilic) granules), no morphologic dysplasia, and no evidence of extramedullary disease|Participants were monitored up until the point when they went off study following completion of the treatment (3 months)|||participants|||Number
677558|NCT01607593|Primary|Clinical Global Impression of Severity (CGI-S) at End of Administration/Observation|Number of participants in each category of CGI-S at start and end of administration/observation. CGI-S is a 7-point clinician-rated scale to assess severity of participant's current illness state, ranging from (1)Normal, not ill at all, (2)Borderline mentally ill, (3)Mildly ill, (4)Moderately ill, (5)Markedly ill, (6)Severely ill, (7)Among the most severely ill.|Up to 6 years|FAS was defined as those who had a record of either CGI-I or CGI-S.||Participants|||Number
677559|NCT01607593|Primary|Clinical Global Impression of Severity (CGI-S) at Start of Administration/Observation|Number of participants in each category of CGI-S at start and end of administration/observation. CGI-S is a 7-point clinician-rated scale to assess severity of participant's current illness state, ranging from (1)Normal, not ill at all, (2)Borderline mentally ill, (3)Mildly ill, (4)Moderately ill, (5)Markedly ill, (6)Severely ill, (7)Among the most severely ill.|Start of administration|FAS was defined as those who had a record of either CGI-I or CGI-S.||Participants|||Number
677560|NCT01607593|Primary|Clinical Global Impression - Improvement (CGI-I) at End of Administration/Observation|Number of participants in each category of CGI-I at end of administration/observation. CGI-I is a 7-point clinician-rated scale, ranging from (1) Very much improved, (2)Much improved, (3) Minimally improved, (4) No change, (5) Minimally worse, (6) Much worse, and (7) Very much worse.|Up to 6 years|Full analysis set (FAS) was defined as those who had a record of either CGI-I or Clinical Global Impression of Severity (CGI-S).||Participants|||Number
677573|NCT01607398|Secondary|Change From Baseline in the COPD Assessment Test (CAT) Total Score at Week 12|Participants completed the CAT questionnaire before undergoing respiratory function tests at Baseline and at Week 12. The CAT questionnaire is an 8-item questionnaire (comprised of Question [Q] 1 to Q8; each question scored from 0 to 5) designed to assess the health status of participants with COPD. The total score is calculated as the sum of the scores from Questions 1 to 8, for a range of possible scores of 0 to 40. A higher total score represents a lower quality of life, and vice versa. Change from Baseline was calculated as the Week 12 score minus the Baseline score.|Baseline and Week 12|Per Protocol Population||Scores on a scale||Standard Deviation|Mean
677561|NCT01607476|Primary|Global Distribution of F18 Flutemetamol in the Brain|"The imaging analysts use a global atlas of the brain to measure the uptake of the radioactive tracer (or brightness) globally. This global uptake was normalized to the uptake in the cerebellar crus region of the brain to get a global Standard Uptake Value Ratio (SUVR). The cerebral crus (crus cerebri) is the anterior portion of the cerebral peduncle which contains the motor tracts.
The standard uptake value (SUV) is a way of determining activity in PET imaging. The SUVR is the ratio of SUV from two different regions within the same PET image. For the SUVR, the injected activity, the body weight and the volume to mass conversion factor that are all part of the SUV calculation, cancel."|Approximately one hour after injection of positron emission tomography (PET) drug|||standard uptake value ratio||Standard Deviation|Mean
677562|NCT01607476|Primary|Global Distribution of C11 PiB in the Brain|"The imaging analysts use a global atlas of the brain to measure the uptake of the radioactive tracer (or brightness) globally. This global uptake was normalized to the uptake in the cerebellar crus region of the brain to get a global Standard Uptake Value Ratio (SUVR). The cerebral crus (crus cerebri) is the anterior portion of the cerebral peduncle which contains the motor tracts.
The standard uptake value (SUV) is a way of determining activity in PET imaging. The SUVR is the ratio of SUV from two different regions within the same PET image. For the SUVR, the injected activity, the body weight and the volume to mass conversion factor that are all part of the SUV calculation, cancel."|Approximately one hour after injection of positron emission tomography (PET) drug|||standard uptake value ratio||Standard Deviation|Mean
677563|NCT01607450|Secondary|GLP-1 Concentrations|Achieved GLP-1 concentrations at the end of the 12 hour treatment exposure|After 12 hours of GLP-1 exposure|Analyses performed only on the groups with relevant primary outcome data observed||pmol/L||Standard Deviation|Mean
677564|NCT01607450|Secondary|Cardiac Index|Impedance cardiography-derived measurement of cardiac index, assessed following 12 hour exposure to treatment condition concurrent with the PET measurements.|After 12 hours of GLP-1 exposure|Analyses performed only on the groups with relevant primary outcome data observed||L/min/m^2||Standard Deviation|Mean
677565|NCT01607450|Secondary|Myocardial Total Oxidation Rate|MVO2 derived from acetate kinetics|After 12 hours of GLP-1 exposure|||ml/min/100g||Standard Deviation|Mean
677566|NCT01607450|Secondary|Myocardial Blood Flow|Myocardial perfusion derived from acetate kinetics|After 12 hours of GLP-1 exposure|||ml/min/100g||Standard Deviation|Mean
677567|NCT01607450|Primary|Myocardial Glucose Uptake.|Myocardial glucose uptake measured using 18FDG PET, quantified using a 3-compartment model with a lumped constant of 1.0.|After 12 hours of glucagon-like peptide 1 (GLP-1) exposure|||umol/min/100g||Standard Deviation|Mean
677568|NCT01607411|Secondary|Enamel Fluoride Uptake|Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on amount of F divided by volume of the enamel cores and expressed as micrograms (μg)* F/centimeters(cm)^2. Difference between treatments was calculated with respect to F uptake by enamel.|Baseline to 4 hours|Per Protocol (PP) Population: All randomized participants who received at least one study product, had one efficacy assessment and did not have any protocol violations deemed to affect efficacy. Missing enamel specimen values were imputed, by averaging over the available enamel specimens||μg*F/cm^2||Standard Error|Mean
677569|NCT01607411|Secondary|Percent Net Acid Resistance (%NAR) of Enamel Specimens|Changes in mineral content of enamel specimens exposed to dietary erosive challenge were determined by measuring the length of the indentations. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine NAR which compared the indentations values of sound enamel specimens at baseline (B), first demineralization challenge (D1) and second demineralization challenge (D2). Percent NAR was calculated by formula: [(D1-D2)/ (D1-B)]*100.|Baseline to 4 hours|Per Protocol (PP) Population: All randomized participants who received at least one study product, had one efficacy assessment and did not have any protocol violations deemed to affect efficacy. Missing enamel specimen values were imputed, by averaging over the available enamel specimens.||%NAR||Standard Error|Mean
677570|NCT01607411|Secondary|%SMHR of Enamel Specimens Exposed to Test Treatments|Surface microhardness recovery (SMHR) test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first demineralization challenge (D1) using formula: [(D1-R)/ (D1-B)]*100.|Baseline to 4 hours|Per Protocol (PP) Population: All randomized participants who received at least one study product, had one efficacy assessment and did not have any protocol violations deemed to affect efficacy. Missing enamel specimen values were imputed, by averaging over the available enamel specimens.||%SMHR||Standard Error|Mean
677571|NCT01607411|Primary|Percentage Surface Microhardness Recovery of Test Dentifrices Relative to Placebo Dentifrice|Surface microhardness recovery (SMHR) test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first demineralization challenge (D1) using formula: [(D1-R)/ (D1-B)]*100.|Baseline to 4 hours|Per Protocol (PP) Population: All randomized participants who received at least one study product, had one efficacy assessment and did not have any protocol violations deemed to affect efficacy. Missing enamel specimen values were imputed, by averaging over the available enamel specimens.||%SMHR||Standard Error|Mean
677572|NCT01607398|Secondary|Number of Participants Who Experienced the Indicated Number of COPD Exacerbations During the Treatment Period|The occurrence of a COPD exacerbation was assessed on each day of evaluation during the treatment period per the defined severity classifications. COPD exacerbations were classified based on severity as a mild exacerbation (exacerbation of COPD symptoms were manageable by the participant, not requiring systemic corticosteroid or antimicrobial therapy), a moderate exacerbation (exacerbation of COPD symptoms required systemic corticosteroid or antimicrobial therapy), or a severe exacerbation (exacerbation of COPD symptoms required hospitalization). The number of participants who experienced 0, 1, 2, and >=3 exacerbation(s) was summarized.|From Baseline up to Week 12|Per Protocol Population||Participants|||Number
677574|NCT01607398|Secondary|Change From Baseline in the COPD Assessment Test (CAT) Question 8 Score at Week 12|Participants completed the CAT questionnaire before undergoing respiratory function tests at Baseline and at Week 12. The CAT questionnaire is an 8-item questionnaire (comprised of Question [Q] 1 to Q8) designed to assess the health status of participants with COPD. In Question 8, participants were asked to rate how much energy they have on a scale of 0 to 5: 0, “I have lots of energy”; 5, “I have no energy at all.” Change from Baseline was calculated as the Week 12 score minus the Baseline score.|Baseline and Week 12|Per Protocol Population||Scores on a scale||Standard Deviation|Mean
677575|NCT01607398|Secondary|Change From Baseline in the COPD Assessment Test (CAT) Question 7 Score at Week 12|Participants completed the CAT questionnaire before undergoing respiratory function tests at Baseline and at Week 12. The CAT questionnaire is an 8-item questionnaire (comprised of Question [Q] 1 to Q8) designed to assess the health status of participants with COPD. In Question 7, participants were asked to rate how soundly they sleep on a scale of 0 to 5: 0, “I sleep soundly”; 5, “I don't sleep soundly because of my lung condition.” Change from Baseline was calculated as the Week 12 score minus the Baseline score.|Baseline and Week 12|Per Protocol Population||Scores on a scale||Standard Deviation|Mean
677576|NCT01607398|Secondary|Change From Baseline in the COPD Assessment Test (CAT) Question 6 Score at Week 12|Participants completed the CAT questionnaire before undergoing respiratory function tests at Baseline and at Week 12. The CAT questionnaire is an 8-item questionnaire (comprised of Question [Q] 1 to Q8) designed to assess the health status of participants with COPD. In Question 6, participants were asked to rate how confident they are leaving home despite their lung condition on a scale of 0 to 5: 0, “I am confident leaving my home despite my lung condition”; 5, “I am not at all confident leaving my home because of my lung condition.” Change from Baseline was calculated as the Week 12 score minus the Baseline score.|Baseline and Week 12|Per Protocol Population||Scores on a scale||Standard Deviation|Mean
677577|NCT01607398|Secondary|Change From Baseline in the COPD Assessment Test (CAT) Question 5 Score at Week 12|Participants completed the CAT questionnaire before undergoing respiratory function tests at Baseline and at Week 12. The CAT questionnaire is an 8-item questionnaire (comprised of Question [Q] 1 to Q8) designed to assess the health status of participants with COPD. In Question 5, participants were asked to rate how limited they are in doing activities at home on a scale of 0 to 5: 0, “I am not limited doing any activities at home”; 5, “I am very limited doing activities at home.” Change from Baseline was calculated as the Week 12 score minus the Baseline score.|Baseline and Week 12|Per Protocol Population||Scores on a scale||Standard Deviation|Mean
677578|NCT01607398|Secondary|Change From Baseline in the COPD Assessment Test (CAT) Question 4 Score at Week 12|Participants completed the CAT questionnaire before undergoing respiratory function tests at Baseline and at Week 12. The CAT questionnaire is an 8-item questionnaire (comprised of Question [Q] 1 to Q8) designed to assess the health status of participants with COPD. In Question 4, participants were asked to rate how breathless they feel when walking up a flight of stairs or a hill on a scale of 0 to 5: 0, “When I walk up a hill or one flight of stairs I am not breathless”; 5, “When I walk up a hill or one flight of stairs I am very breathless.” Change from Baseline was calculated as the Week 12 score minus the Baseline score.|Baseline and Week 12|Per Protocol Population||Scores on a scale||Standard Deviation|Mean
677579|NCT01607398|Secondary|Change From Baseline in the COPD Assessment Test (CAT) Question 3 Score at Week 12|Participants completed the CAT questionnaire before undergoing respiratory function tests at Baseline and at Week 12. The CAT questionnaire is an 8-item questionnaire (comprised of Question [Q] 1 to Q8) designed to assess the health status of participants with COPD. In Question 3, participants were asked to rate how tight their chest feels on a scale of 0 to 5: 0, “My chest does not feel tight at all”; 5, “My chest feels very tight.” Change from Baseline was calculated as the Week 12 score minus the Baseline score.|Baseline and Week 12|Per Protocol Population||Scores on a scale||Standard Deviation|Mean
677580|NCT01607398|Secondary|Change From Baseline in the COPD Assessment Test (CAT) Question 2 Score at Week 12|Participants completed the CAT questionnaire before undergoing respiratory function tests at Baseline and at Week 12. The CAT questionnaire is an 8-item questionnaire (comprised of Question [Q] 1 to Q8) designed to assess the health status of participants with COPD. In Question 2, participants were asked to rate the amount of phlegm (mucus) in their chest on a scale of 0 to 5: 0, “I have no phlegm (mucus) in my chest at all”; 5, “My chest is completely full of phlegm (mucus).” Change from Baseline was calculated as the Week 12 score minus the Baseline score.|Baseline and Week 12|Per Protocol Population||Scores on a scale||Standard Deviation|Mean
677581|NCT01607398|Secondary|Change From Baseline in the COPD Assessment Test (CAT) Question 1 Score at Week 12|"Participants completed the CAT questionnaire before undergoing respiratory function tests at Baseline and at Week 12. The CAT questionnaire is an 8-item questionnaire (comprised of Question [Q] 1 to Q8) designed to assess the health status of participants with COPD. In Question 1, participants were asked to rate how much they cough on a scale of 0 to 5: 0, I never cough; 5, I cough all the time. Change from Baseline was calculated as the Week 12 score minus the Baseline score."|Baseline and Week 12|Per Protocol Population||Scores on a scale||Standard Deviation|Mean
677582|NCT01607398|Secondary|Change From Baseline in Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) at Week 12|FEV1 and FVC are measures of lung function. FEV1 is defined as the maximal amount of air that can be forcefully exhaled in one second. FVC is defined as the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. Respiratory function tests were performed for the measurement of FEV1 and FVC at Baseline and at Week 12. The values were measured at 15 to 60 minutes following the use of a pressurized metered-dose inhaler. Three technically acceptable values were obtained, and the highest value was recorded. Change from Baseline in FEV1 and FVC was calculated as the Week 12 value minus the Baseline value.|Baseline and Week 12|Per Protocol Population||Liters (L)||Inter-Quartile Range|Median
677583|NCT01607398|Secondary|Change From Baseline in Fibrinogen Levels in Serum at Week 12|Per Protocol Amendment 4, the measurement of fibrinogen levels in serum was removed from the analysis plan because fibrinogen levels were found to be too low and too difficult to measure.|Baseline and Week 12||||||
677584|NCT01607398|Secondary|Change From Baseline in hsCRP, SP-D, and Clara Cell Protein 16 (CC 16) Levels in Serum at Week 12|Serum samples were collected at Baseline and at Week 12. The levels of hsCRP, SP-D, and CC16 in serum samples were measured at the same time using the multiplex assay system. Change from Baseline in hsCRP, SP-D, and CC16 was calculated as the Week 12 value minus the Baseline value.|Baseline and Week 12|Per Protocol Population||ng/mL||Inter-Quartile Range|Median
677585|NCT01607398|Secondary|Change From Baseline in IL-6 and IL-8 Levels in Serum at Week 12|Serum samples were collected at Baseline and at Week 12. The levels of IL-6 and IL-8 in serum samples were measured at the same time using the multiplex assay system. Change from Baseline in IL-6 and IL-8 levels was calculated as the Week 12 value minus the Baseline value.|Baseline and Week 12|Per Protocol Population||pg/mL||Inter-Quartile Range|Median
677586|NCT01607398|Secondary|Change From Baseline in Myeloperoxidase (MPO) and Pulmonary Surfactant Protein (SP)-D Levels in Sputum Supernatant at Week 12|Induced sputum samples were collected at Baseline and at Week 12. The levels of MPO and SP-D in the supernatant of an induced sputum sample were measured at the same time using the multiplex assay system. Change from Baseline in MPO and SP-D levels was calculated as the Week 12 value minus the Baseline value.|Baseline and Week 12|Per Protocol Population. Only those participants available at the specified time points were analyzed.||ng/mL||Inter-Quartile Range|Median
677587|NCT01607398|Secondary|Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Levels in Sputum Supernatant at Week 12|Data cannot be reported because hsCRP was under the lower limit of detection in all samples.|Baseline and Week 12||||||
677588|NCT01607398|Secondary|Change From Baseline in Interleukin (IL)-8 Levels in Sputum Supernatant at Week 12|Induced sputum samples were collected at Baseline and at Week 12. The levels of IL-8 in the supernatant of an induced sputum sample were measured at the same time using the multiplex assay system. Change from Baseline in IL-8 levels was calculated as the Week 12 value minus the Baseline value.|Baseline and Week 12|Per Protocol Population. Only those participants available at the specified time points were analyzed.||Picograms per milliliter (pg/mL)||Inter-Quartile Range|Median
677589|NCT01607398|Secondary|Change From Baseline in Interferon (INF)-Gamma-positive Cells and Perforin-positive Cells in Sputum at Week 12|INF-gamma-positive cells and perforin-positive cells were not detected in samples collected in this study due to the conditions of the samples and/or antibodies. No re-assays were performed, “no result”/”no data” was entered into the case report forms, and no statistical analysis or data summarization was performed.|Baseline and Week 12||||||
677590|NCT01607398|Secondary|Change From Baseline in All Inflammatory Cell Count in Induced Sputum at Week 12|Induced sputum samples were collected at Baseline and at Week 12. All inflammatory cells in induced sputum were counted with the use of a cytological specimen of cells in the induced sputum. Change from Baseline in all inflammatory cell count was calculated as the Week 12 value minus the Baseline value.|Baseline and Week 12|Per Protocol Population. Only those participants available at the specified time points were analyzed.||Cells per millimeters cubed (cells/mm^3)||Inter-Quartile Range|Median
677591|NCT01607398|Primary|Change From Baseline in Neutrophil Count in Induced Sputum at Week 12|Induced sputum samples were collected at Baseline and at Week 12. The neutrophil count in induced sputum was measured with the use of a cytological specimen of inflammatory cells in the induced sputum. Change from Baseline in neutrophil count was calculated as the Week 12 value minus the Baseline value (percentage of neutrophil of total cells in induced sputum at Week 12 minus the Baseline value).|Baseline and Week 12|Per Protocol Population: all participants who had an evaluable sputum sample at Baseline and at the endpoint of interest, were randomized to study treatment and received at least one dose of study medication, and had no major protocol violations. Only those participants available at the specified time points were analyzed.||ratio (%)||Inter-Quartile Range|Median
677606|NCT01607320|Primary|Pregnancy|Time frame will vary depending on how many treatment cycles it takes to get pregnant. If no pregnancy occurs, study participation will likely be about 4 months.|4 months|The study was randomized between the two treatments and was never unblinded, therefore randomization is unknown|||||
677605|NCT01607320|Secondary|Ovulation|If ovulation does not occur during the first treatment cycle, subject will be withdrawn from study.|Cycle day 22-24||||||
677607|NCT01607203|Secondary|Patients With Cryopreserved Embryos||4 weeks|||patients with cryopreserved embryos|||Number
677608|NCT01607203|Secondary|Pregnancy Rate|the number of pregnancies obtained, wich still is the most important issue for the patients|12 weeks|||pregnancies|||Number
677610|NCT01607112|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|A serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|During the entire study period (Days 0-21)|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.||Subjects|||Number
677611|NCT01607112|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.|During the 21-day follow-up period (Days 0-20) after vaccination|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.||Subjects|||Number
677612|NCT01607112|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.|"Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, increased sweating and fever [axillary temperature above 37.5 degrees Celsius (°C)]. Gastrointestinal symptoms included nausea, vomiting, diarrhea and/or abdominal pain.
Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature above 39.0°C"|During the 4-day follow-up period (Day 0-3) after vaccination|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.||Subjects|||Number
677613|NCT01607112|Secondary|Duration of Solicited General Symptoms.|Duration was defined as number of days with any grade of general symptoms.|During the 4-day follow-up period (Days 0-3) after vaccination|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.||Days||Full Range|Median
677614|NCT01607112|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.|Solicited local symptoms assessed were ecchymosis, induration, pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal everyday activities. Grade 3 ecchymosis, induration, redness and swelling was greater than 100 millimeters (mm) i.e. >100mm.|During the 4-day (Day 0-Day 3) follow-up period after vaccination|Analysis was performed on the Total Vaccinated cohort which included all subjects with vaccine administration documented.||Subjects|||Number
677615|NCT01607112|Secondary|Duration of Solicited Local Symptoms.|Duration was defined as number of days with any grade of local symptoms.|During the 4-day follow-up period (Days 0-3) after vaccination|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.||Days||Full Range|Median
677616|NCT01607112|Secondary|Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains.|MGI was defined as the fold increase in serum HI GMT post-vaccination compared to Day 0. This outcome measure was assessed by influenza vaccination status in the 2011-2012 season, in subjects aged > 60 years.|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||Fold increase||95% Confidence Interval|Geometric Mean
677617|NCT01607112|Primary|Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the Three Vaccine Influenza Strains Above the Cut-off Value.|SPP was defined as the number of vaccinees with a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:40.|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||Subjects|||Number
677618|NCT01607112|Primary|Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains.|MGI was defined as the fold increase in serum HI GMT post-vaccination compared to Day 0.|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||Fold increase||95% Confidence Interval|Geometric Mean
677619|NCT01607112|Secondary|Number of Subjects Who Seroconverted for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains.|SCR was defined as the number of vaccinees with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least 4-fold increase in post-vaccination titer. The outcome measure was assessed by influenza vaccination status in the 2011-2012 season, in subjects aged > 60 years.|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||Subjects|||Number
677620|NCT01607112|Secondary|Number of Subjects Who Were Seroprotected for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains.|Seroprotection rate SPR was defined as the number of vaccinees with serum haemagglutination inhibition (HI) titer greater than or equal to (≥) 1:40. The outcome measure was assessed by the influenza vaccination status in the 2011-2012 season, in subjects aged > 60 years.|At Day 0 and Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||Subjects|||Number
677621|NCT01607112|Secondary|Humoral Immune Response in Terms of Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains.|Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains included H1N1, H3N2 and Yamagata antigens. The outcome measure was assessed by influenza vaccination status in the 2011-2012 season, in subjects aged greater than (>) 60 years.|At Day 0 and Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||Titer||95% Confidence Interval|Geometric Mean
677622|NCT01607112|Primary|Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains.|A seroconverted subjects was defined as a vaccinee with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||Subjects|||Number
677623|NCT01607112|Primary|Number of Subjects Who Were Seroprotected for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains.|Seroprotection rate (SPR) was defined as the number of vaccinees with serum haemagglutination inhibition (HI) titer greater than or equal to (≥) 1:40.|At Day 0 and Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||Subjects|||Number
677624|NCT01607112|Primary|Humoral Immune Response in Terms of Haemagglutination (HA) Antibody Titers Against Each of the Three Vaccine Influenza Strains|Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/10 (H1N1), Flu A/Victoria/361/11 (H3N2) and Flu B/Hubei-Wujiagang/158/09 (Yamagata).|At Day 0 and Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||Titer||95% Confidence Interval|Geometric Mean
677625|NCT01606800|Primary|Number of Participants Achieving Sustained Virologic Response (SVR)|SVR was defined as undetectable HCV RNA levels 24 weeks after the completion of therapy.|At 24 weeks after the completion of therapy (up to 72 weeks)|All Treated Population, which included all participants who received at least one dose of study medication after RVR.||Participants|||Number
677626|NCT01606748|Primary|PK: Dose Normalized AUC(0-∞) of Gemcitabine||Run-In Period Day 1 Cohort 1: 0,0.5,1,1.5,3,4,6.67 and 24h Post Start of Infusion; Cycle 1, Day 1: 0, 0.50, 1, 1.5, 3, 4.67, 6.67 and 24 h Post Start of Infusion|All participants who received at least one dose of study drug and had evaluable data for PK. Per protocol, no data were collected for this assessment for participants in Cohort 2.||ng*h/mL/mg||Geometric Coefficient of Variation|Geometric Mean
677627|NCT01606748|Primary|PK: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity, (AUC[0-∞]) of Necitumumab||Run-In Period Day 3 Cohort 1: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 h Post Start of Infusion; Cycle 1 Day 1: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 h Post Start of Infusion|All participants who received at least one dose of study drug and had evaluable data for PK.||ug*h/mL||Geometric Coefficient of Variation|Geometric Mean
677628|NCT01606748|Primary|PK: Dose-Normalized AUC(0-5) of Cisplatin||Run-In Period Day 1 Cohort 1: 0, 2, 2.03, 2.25, 3, 3.67 and 5.67 h Post Start of Infusion; Cycle 1, Day 1: 0, 2, 2.03, 2.25, 3, 3.67 and 5.67 h Post Start of Infusion|All participants who received at least one dose of study drug and had evaluable data for PK. Per protocol, no data were collected for this assessment for participants in Cohort 2.||ng*h/mL/mg||Geometric Coefficient of Variation|Geometric Mean
677629|NCT01606748|Secondary|PK: AUC(0-∞) of Necitumumab After Administration of Process C and Process D Drug Product||Run-In Period Day 3 Cohort 1 and Cohort 2: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 h Post Start of Infusion|All participants who received at least one dose of study drug and had evaluable data for PK.||ug*h/mL||Geometric Coefficient of Variation|Geometric Mean
677630|NCT01606748|Primary|PK: Dose-Normalized AUC(0-24) of Gemcitabine||Run-In Period Day 1 Cohort 1: 0,0.5,1,1.5,3,4,6.67 and 24h Post Start of Infusion; Cycle 1, Day 1: 0, 0.50, 1, 1.5, 3, 4.67, 6.67 and 24 h Post Start of Infusion|All participants who received at least one dose of study drug and had evaluable data for PK. Per protocol, no data were collected for this assessment for participants in Cohort 2.||ng*h/mL/mg||Geometric Coefficient of Variation|Geometric Mean
677631|NCT01606748|Secondary|PK: Cmax of Necitumumab After Administration of Process C and Process D Drug Product||Run-In Period Day 3 Cohort 1 and Cohort 2: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 h Post Start of Infusion|All participants who received at least one dose of study drug and had evaluable data for PK.||ug/mL||Geometric Coefficient of Variation|Geometric Mean
677632|NCT01606748|Secondary|Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR]) (Antitumor Activity of Necitumumab in Combination With Gemcitabine-cisplatin Chemotherapy)|ORR is confirmed best overall tumor response of CR or PR. According to RECIST v1.1, CR was defined as the disappearance of all target and non-target lesions; PR defined as a >30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD. Percentage of participants was calculated as: (total number of participants with CR or PR from start of the treatment until disease progression or recurrence)/total number of participants treated) * 100.|Baseline to Measured Progressive Disease (Up to 14 Months)|All participants who received at least one dose of study drug.||percentage of participants||95% Confidence Interval|Number
677633|NCT01606748|Secondary|Number of Participants With Anti-Necitumumab Antibodies|A participant was considered to have an anti-necitumumab antibody response if anti-drug antibodies (ADA) were confirmed positive. Treatment emergent antibodies were defined as any anti-necitumumab antibody titer equal to or greater than 4-fold the participant's baseline titer.|Baseline through, 30-Day Follow-Up|All participants who received at least one dose of study drug and had evaluable baseline and postbaseline data for antibodies.||participants with immunogenicity samples|||Number
677634|NCT01606748|Primary|PK: Area Under Concentration-Time Curve From Zero to Time 168 (AUC[-168]) of Necitumumab||Run-In Period Day 3 Cohort 1: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 h Post Start of Infusion; Cycle 1, Day 1: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 h Post Start of Infusion|All participants who received at least one dose of study drug and had evaluable data for PK. Per protocol, no data were collected for this assessment for participants in Cohort 2.||ug*hour(h)/mL||Geometric Coefficient of Variation|Geometric Mean
677635|NCT01606748|Primary|PK: Dose-Normalized Cmax of Cisplatin||Run-In Period Day 1 Cohort 1: 0, 2, 2.03, 2.25, 3, 3.67 and 5.67 h Post Start of Infusion; Cycle 1, Day 1: 0, 2, 2.03, 2.25, 3, 3.67 and 5.67 h Post Start of Infusion|All participants who received at least one dose of study drug and had evaluable data for PK. Per protocol, no data were collected for this assessment for participants in Cohort 2.||nanogram (ng)/mL/mg||Geometric Coefficient of Variation|Geometric Mean
681434|NCT01556906|Secondary|Absolute Change From Baseline in Total Bilirubin|Absolute change from Baseline in total bilirubin|Baseline and 16 weeks of treatment|All patients treated||mg/dL||Standard Deviation|Mean
677636|NCT01606748|Primary|PK: Dose-Normalized Cmax of Gemcitabine||Run-In Period Day 1 Cohort 1: 0,0.5,1,1.5,3,4,6.67 and 24h Post Start of Infusion; Cycle 1, Day 1: 0, 0.50, 1, 1.5, 3, 4.67, 6.67 and 24 h Post Start of Infusion|All participants who received at least one dose of study drug and had evaluable data for PK. Per protocol, no data were collected for this assessment for participants in Cohort 2.||nanogram(ng)/mL/mg||Geometric Coefficient of Variation|Geometric Mean
677637|NCT01606748|Primary|Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Necitumumab||Run-In Period Day 3 Cohort 1: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 Hour (h) Post Start of Infusion; Cycle 1, Day 1: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 h Post Start of Infusion|All participants who received at least one dose of study drug and had evaluable data for PK.||microgram/milliliter (ug/mL)||Geometric Coefficient of Variation|Geometric Mean
677638|NCT01606735|Primary|Anterior Chamber Cell Count at Day 8 Post-Treatment|This study will measure as its primary endpoint the anterior chamber cell count at Day 8 post-treatment. The proportion of patients with anterior chamber cell count = 0 at Day 8 for each dosage group will be compared.|8 days post-treatment|||percentage of patients with ACC clearing||95% Confidence Interval|Number
677639|NCT01606670|Secondary|Change From Baseline to Visit 2 in the Short-form Parkinson's Disease Questionnaire (PDQ-8) Total Score|The PDQ-8 is a self-administered 8 item questionnaire that assesses the overall health status. The questions will be rated from 0 (never) to 4 (always [or cannot do at all]). The total score ranges from 0 (never) to 32 (always [or cannot do at all]) with lower scores indicating a better health status.|From Baseline (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro®)|Full Analysis Set (FAS). The FAS includes all enrolled patients who had applied the rotigotine transdermal patch at least once and for whom valid data for the primary effectiveness variable were available from Baseline and a subsequent routine visit.||units on a scale||Standard Deviation|Mean
677640|NCT01606670|Secondary|Change From Baseline to Visit 2 in the Sum Score of the Unified Parkinson's Disease Rating Scale (UPDRS) Parts II+III|The UPDRS is a scale for the assessment of function in Parkinson's disease. Part II measures 'Activities of Daily Living' and Part III 'Motor Function'. They consist of 40 questions, each ranging from 0 (normal) to 4 (severe abnormalities). The sum score of the UPDRS Part II+III ranges from 0 (normal) to 160 (worst score possible).|From Baseline (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro®)|Of the 70 patients in the Full Analysis Set (FAS), 68 patients had complete data for UPDRS Part II and 67 patients had complete data for UPDRS Part III. Thus, of the 70 patients in the FAS, 67 patients are included in the analysis of this outcome measure.||units on a scale||Standard Deviation|Mean
677641|NCT01606670|Secondary|Change From Baseline to Visit 2 in the Sum Score of the Unified Parkinson's Disease Rating Scale (UPDRS) Part III|The UPDRS is a scale for the assessment of function in Parkinson's disease. Part III measures 'Motor Function'. It consists of 14 items with 27 questions, each ranging from 0 (normal) to 4 (severe abnormalities). The sum score of the UPDRS Part III ranges from 0 (normal) to 108 (worst score possible).|From Baseline (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro®)|Of the 70 patients in the Full Analysis Set (FAS), 67 patients had complete data for UPDRS Part III and are included in the analysis of this outcome measure.||units on a scale||Standard Deviation|Mean
677642|NCT01606670|Secondary|Change From Baseline to Visit 2 in the Sum Score of the Unified Parkinson's Disease Rating Scale (UPDRS) Part II|The UPDRS is a scale for the assessment of function in Parkinson's disease. Part II measures 'Activities of Daily Living'. It consists of 13 questions, each ranging from 0 (none) to 4 (severe abnormalities). The sum score of the UPDRS Part II ranges from 0 (normal) to 52 (worst score possible).|From Baseline (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro®)|Of the 70 patients in the Full Analysis Set (FAS), 68 patients had complete data for UPDRS Part II and are included in the analysis of this outcome measure.||units on a scale||Standard Deviation|Mean
677643|NCT01606670|Primary|Change From Baseline to Visit 2 in the Sum Score Calculated From the 4 Items of the Affective Dimension of the Pain Description List (Schmerzbeschreibungsliste SBL, Question 10) of the German Pain Questionnaire|"The Pain Description List (SBL, question 10) is part of the validated German Pain Questionnaire (DSF).
The SBL consists of a 12 item list of adjectives. Each adjective is ranked from 0 (not applicable) to 3 (exactly applicable).
8 of the 12 adjectives will be used to assess the sensory items of pain and 4 adjectives to describe the affective items of pain.
The 8 sensory items are used to assess qualitative description of pain. For the 4 affective pain items, a sum score ranges from 0 (not applicable) to 12 (exactly applicable). Values above 8 can be considered noticeable."|From Baseline (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro®)|Full Analysis Set (FAS). The FAS includes all enrolled patients who had applied the rotigotine transdermal patch at least once and for whom valid data for the primary effectiveness variable were available from Baseline and a subsequent routine visit.||units on a scale||Standard Deviation|Mean
677644|NCT01606319|Secondary|Health Care Utilization|frequency of unscheduled physician visits, emergency department visits or hospitalizations for asthma|last 46 weeks of 48 week treatment period|Two participants in the ibuprofen arm dropped out of the study during the first two weeks of the study and were not included in the analysis per the pre-specified analysis plan.||unscheduled health visits per 46 weeks||95% Confidence Interval|Mean
677645|NCT01606319|Secondary|Asthma Rescue Medication Use|average albuterol rescue use per week, measured by electronic diary|last 46 weeks of 48 week treatment period|Two participants in the ibuprofen arm dropped out of the study during the first two weeks of the study and were not included in the analysis per the pre-specified analysis plan.||inhalations per week||95% Confidence Interval|Mean
677646|NCT01606319|Secondary|Asthma Control Days|proportion of study days on which asthma was controlled, measured by electronic diary|last 46 weeks of 48 week treatment period|Two participants in the ibuprofen arm dropped out of the study during the first two weeks of the study and were not included in the analysis per the pre-specified analysis plan.||proportion of days||95% Confidence Interval|Mean
677647|NCT01606319|Primary|Exacerbation Frequency|the number of asthma exacerbations requiring systemic corticosteroids|last 46 weeks of 48 week treatment period|Two participants in the ibuprofen arm dropped out of the study during the first two weeks of the study and were not included in the analysis per the pre-specified analysis plan.||asthma exacerbations per 46 weeks||95% Confidence Interval|Mean
678170|NCT01600482|Secondary|The Secondary Safety Endpoint Will be the Combined Rate of Minor Complications With in 30 +/- 7 Days Following Procedure.|combined rate of minor complications with in 30 +/- 7 days following procedure.|With in the first 30 days +/- 7 days following the procedure|||minor complications|||Number
677648|NCT01606306|Primary|Differential Response to the Three Therapies Based on Fixed Threshold Criteria for the Following Asthma Control Measures: Use of Oral Prednisone for Acute Asthma Exacerbations and Asthma Control Days.|The primary outcome was differential response to the three therapies on the basis of fixed threshold criteria for the following asthma control measures, which encompassed domains of risk and impairment: the time from the start of the treatment period to an asthma exacerbation treated with systemic corticosteroids, and the annualized number of asthma control days (ACDs) from within that period. ACDs were defined as full calendar days without symptoms, rescue medication use, or unscheduled healthcare visits. Children were defined as differential responders if, first, the time to an asthma exacerbation was at least four weeks longer, or second, if the number of annualized ACDs was at least 31 days more for one treatment than another, in that order. If neither threshold was met, the participant was considered a non differential responder. Differential response was determined in children completing at least two treatment periods and at least 50% of the daily diary entries for each period.|The last 14 weeks of each 16-week treatment period|Differential response was determined in children completing at least two treatment periods and at least 50% of the daily diary entries for each period.||probability||95% Confidence Interval|Number
677649|NCT01606254|Secondary|Number of Participants With Clinical Global Impression Severity (CGI-S) Score|"The CGI-S rating scale is a 7 point (1-absent, 2-minimal, 3-mild, 4-moderate, 5-moderate severe, 6-severe, 7-extreme) global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to normal, not at all ill and a rating of 7 is equivalent to among the most extremely ill participants. Higher scores indicate worsening."|Baseline, Day 8, 22, 50, 78 and 92|The PPS included all participants who were enrolled in the study, received study medication at least once and had at least one efficacy evaluation. LOCF imputation method was used. Here ‘n’ signifies participants evaluable for this measure at specified time point for each arm group.||Participants|||Number
677650|NCT01606254|Secondary|Positive and Negative Syndrome Scale (PANSS) Total Score|The PANSS is a medical scale that assesses various symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill).|Baseline, Day 8, 22, 50, 78 and 92|Per protocol set (PPS) included all participants who were enrolled in the study, received study medication at least once and had at least one efficacy evaluation. Last observation carried forward (LOCF) imputation method was used. Here ‘n’ signifies participants evaluable for this measure at specified time point for each arm group.||units on a scale||Standard Deviation|Mean
677651|NCT01606254|Primary|Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 218|The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 [none, normal]; 1 [Very Mild]; 2 [Mild]; 3 [Moderate]; 4 [severe]).|Day 218|Safety analysis set included all participants who were enrolled in the study and received the study medication at least once. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.||Participants|||Number
677652|NCT01606254|Primary|Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 162|The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 [none, normal]; 1 [Very Mild]; 2 [Mild]; 3 [Moderate]; 4 [severe]).|Day 162|Safety analysis set included all participants who were enrolled in the study and received the study medication at least once. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.||Participants|||Number
677653|NCT01606254|Primary|Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 120|The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 [none, normal]; 1 [Very Mild]; 2 [Mild]; 3 [Moderate]; 4 [severe]).|Day 120|Safety analysis set included all participants who were enrolled in the study and received the study medication at least once. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.||Participants|||Number
677654|NCT01606254|Primary|Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 92|The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 [none, normal]; 1 [Very Mild]; 2 [Mild]; 3 [Moderate]; 4 [severe]).|Day 92|Safety analysis set included all participants who were enrolled in the study and received the study medication at least once. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.||Participants|||Number
677655|NCT01606254|Primary|Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 78|The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 [none, normal]; 1 [Very Mild]; 2 [Mild]; 3 [Moderate]; 4 [severe]).|Day 78|Safety analysis set included all participants who were enrolled in the study and received the study medication at least once. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.||Participants|||Number
677729|NCT01606137|Secondary|Subject Assessment of Benefit at the Last Study Visit in Those Experiencing Central Neuropathic Pain.|Assessment of benefit achieved at study completion/withdrawal was evaluated by the subject, and the number of subjects who perceived a benefit from treatment is presented.|Up to 1051 days|All subjects who entered the study from a neuropathic pain parent RCT and received at least one actuation of study medication were included in the efficacy analysis.||participants|||Number
677656|NCT01606254|Primary|Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 50|The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 [none, normal]; 1 [Very Mild]; 2 [Mild]; 3 [Moderate]; 4 [severe]).|Day 50|Safety analysis set included all participants who were enrolled in the study and received the study medication at least once. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.||Participants|||Number
677657|NCT01606254|Primary|Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 22|The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 [none, normal]; 1 [Very Mild]; 2 [Mild]; 3 [Moderate]; 4 [severe]).|Day 22|Safety analysis set included all participants who were enrolled in the study and received the study medication at least once. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.||Participants|||Number
677658|NCT01606254|Primary|Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 8|The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 [none, normal]; 1 [Very Mild]; 2 [Mild]; 3 [Moderate]; 4 [severe]).|Day 8|Safety analysis set included all participants who were enrolled in the study and received the study medication at least once.||Participants|||Number
677659|NCT01606254|Primary|Paliperidone Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Days 1, 8, 15, 22, 36, 50, 64, 67, 71, 74, 78, 85, 92, 106, 120, 134, 162, 190, 218 and early withdrawal|Pharmacokinetic analysis set included all participants who received the study medication and whose plasma drug concentrations were available. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.||Days||Standard Deviation|Mean
677660|NCT01606254|Primary|Plasma Paliperidone Concentration at Steady State (Css av)|The Css av is defined as value of average analyte concentration at steady-state (after 4 Intramuscular Injections of Paliperidone Palmitate).|Days 1, 8, 15, 22, 36, 50, 64, 67, 71, 74, 78, 85, 92, 106, 120, 134, 162, 190, 218 and early withdrawal|Pharmacokinetic analysis set included all participants who received the study medication and whose plasma drug concentrations were available. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.||ng/ml||Standard Deviation|Mean
677661|NCT01606254|Primary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)|The AUCtau is a measure of the plasma paliperidone concentration from time zero to end of dosing interval. It is used to characterize drug absorption.|Days 1, 8, 15, 22, 36, 50, 64, 67, 71, 74, 78, 85, 92, 106, 120, 134, 162, 190, 218 and early withdrawal|Pharmacokinetic analysis set included all participants who received the study medication and whose plasma drug concentrations were available. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.||nanogram*hour per milliliter||Standard Deviation|Mean
677662|NCT01606254|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Paliperidone|The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.|Days 1, 8, 15, 22, 36, 50, 64, 67, 71, 74, 78, 85, 92, 106, 120, 134, 162, 190, 218 and early withdrawal|Pharmacokinetic analysis set included all participants who received the study medication and whose plasma drug concentrations were available. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.||Days||Full Range|Median
677663|NCT01606254|Primary|Maximum Observed Plasma Concentration (Cmax) of Paliperidone|The Cmax is defined as maximum observed analyte concentration.|Days 1, 8, 15, 22, 36, 50, 64, 67, 71, 74, 78, 85, 92, 106, 120, 134, 162, 190, 218 and early withdrawal|Pharmacokinetic analysis set included all participants who received the study medication and whose plasma drug concentrations were available. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.||ng/ml||Standard Deviation|Mean
677664|NCT01606254|Primary|Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 92|The Cpredose at Day 92 is defined as the plasma paliperidone concentration obtained after the treatment interval of the study drug (that is 4 weeks) passed after the final dose (Day 92). The mean Cpredose at Day 92 was measured in ng/ml.|Day 92|Pharmacokinetic analysis set included all participants who received the study treatment and whose plasma drug concentrations were available. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.||ng/ml||Standard Deviation|Mean
677665|NCT01606254|Primary|Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 64|The Cpredose at Day 64 is defined as the plasma paliperidone concentration obtained before a dose is given on Day 64. The mean Cpredose at Day 64 was measured in ng/ml.|Day 64|Pharmacokinetic analysis set included all participants who received the study treatment and whose plasma drug concentrations were available. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.||ng/ml||Standard Deviation|Mean
677666|NCT01606254|Primary|Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 36|The Cpredose at Day 36 is defined as the plasma concentration obtained before a dose is given on Day 36. The mean Cpredose at Day 36 was measured in ng/ml.|Day 36|Pharmacokinetic analysis set included all participants who received the study treatment and whose plasma drug concentrations were available. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.||ng/ml||Standard Deviation|Mean
677667|NCT01606254|Primary|Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 8|The pre-dose plasma concentration (Cpredose) at Day 8 is defined as the plasma concentration obtained before a dose is given on Day 8. The mean Cpredose at Day 8 was measured in nanogram per milliliter (ng/ml).|Day 8|Pharmacokinetic analysis set included all participants who received the study treatment and whose plasma drug concentrations were available. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.||ng/ml||Standard Deviation|Mean
677673|NCT01606228|Secondary|Personal and Social Performance (PSP) Scores at Day 90|This PSP assesses the degree of a patient's dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (i, absent to vi, very severe) in each of the 4 domains. Based on the four domains there will be one total score. Patients with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; =< 30, functioning so poorly as to require intensive supervision.|Day 90|Per Protocol (PP) population||scores on a scale||Standard Deviation|Mean
677674|NCT01606228|Secondary|Personal and Social Performance (PSP) Scores at Baseline|This PSP assesses the degree of a patient's dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (i, absent to vi, very severe) in each of the 4 domains. Based on the four domains there will be one total score. Patients with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; =< 30, functioning so poorly as to require intensive supervision.|Baseline|Per Protocol (PP) population||scores on a scale||Standard Deviation|Mean
677675|NCT01606228|Secondary|Clinical Global Impression-Severity (CGIS) Scores at Day 90|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a patient. The rating varies from Normal (not at all ill) to Extreme (among the most extremely ill patients)."|Day 90|Per Protocol (PP) population||participants|||Number
677676|NCT01606228|Secondary|Clinical Global Impression-Severity (CGIS) Scores at Baseline|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a patient. The rating varies from Normal (not at all ill) to Extreme (among the most extremely ill patients)."|Baseline|Per Protocol (PP) population; participants for whom CGIS data was collected.||participants|||Number
677677|NCT01606228|Secondary|Positive and Negative Syndrome Scale (PANSS) Scores at Day 90|The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.|Day 90|Per Protocol (PP) population||scores on a scale||Standard Deviation|Mean
677678|NCT01606228|Secondary|Positive and Negative Syndrome Scale (PANSS) Scores at Baseline|The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.|Baseline|Per Protocol (PP) population||scores on a scale||Standard Deviation|Mean
677679|NCT01606228|Primary|The Proportion of Patients Improving 20% in Total Positive and Negative Syndrome Scale (PANSS) at Endpoint (Day 90)|The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.|Baseline, Day 90|Per Protocol (PP) population||percentage of patients|||Number
677680|NCT01606202|Secondary|Incidence of Adverse Events as a Measure of Patient Safety.|The number of patients who experienced an adverse event during the study is presented.|Up to 61 days|All randomised patients who received at least one dose of study drug were included in the Safety population.||participants|||Number
677681|NCT01606202|Secondary|Change From Baseline in the Mean Sleep Disturbance Numerical Rating Scale Score at the End of Treatment|Each day patients recorded in their patient diary whether they woke during the previous night using the following scoring system: 0 = No, 1 = Once, 2 = Twice, 3 = More than twice, 4 = Awake most of the night. A negative value indicates an improvement from baseline.|0 - 51 days|All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis.||units on a scale||Standard Deviation|Mean
677682|NCT01606202|Secondary|Change From Baseline in the Mean Brief Pain Inventory Score at the End of Treatment|The Brief Pain Inventory is a 14-item questionnaire that asks patients to rate pain over the prior week and the degree to which it interferes with activities on a 0 to 10 scale, where 0=no pain and 10=pain as bad as you can imagine. Severity is measured as worst pain, least pain, average pain, and pain right now. The severity composite score is calculated as the arithmetic mean of the four severity items(range 0-10). A negative value indicates an improvement in worst pain score from baseline.|0 - 51 days|All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis.||units on a scale||Standard Deviation|Mean
677683|NCT01606202|Secondary|Number of Subjects Who Reported an Improvement in Their Overall Condition in the Patient Global Impression of Change at the End of Treatment|The Patient Global Impression of Change asked patients to give their impression of the overall change in their condition during the study at the end of treatment using the following scale: 1 = Very Much Improved, 2 = Much Improved, 3 = Minimally Improved, 4 = No Change, 5 = Minimally Worse, 6 = Much Worse, 7 = Very Much Worse. The number of patients who scored their condition as 1, 2, or 3 (improved) is presented.|Up to 51 days|All patients who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the analysis.||participants|||Number
677684|NCT01606202|Secondary|Change From Baseline in the Mean Caregiver Strain Index Score at the End of Treatment|Carers were asked at baseline and end of treatment to complete the Caregiver Strain Index, as a measure of the strain they felt from being a carer, the maximum possible score being 13. A negative value from baseline indicates an improvement.|Up to 51 days|All caregivers of patients in the current study who responded to the caregiver strain index questionnaire were included in the analysis.||units on a scale||Standard Deviation|Mean
677775|NCT01605877|Primary|Best Corrected Decimal VA (5 m)|VA was tested monocularly at all visits and binocularly at Day 30-60, Day 120-180, and Day 330-420 with the participant's best spectacle correction at a distance of 5 m using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.|Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420|This analysis population includes all implanted subjects.||participants|||Number
677685|NCT01606202|Secondary|Change From Baseline in Mean Spitzer Quality of Life Index Score at the End of Treatment|The Spitzer Quality of Life Index questionnaire consists of five sections, relating to activity, daily living, health, support and outlook. Each section has three choices (numbered 1, 2 and 3) and the patient is required to choose the one that best describes their quality of life during the last week. Choice 1 is scored 2, choice 2 is scored 1 and choice 3 is scored 0. The total Spitzer is the unweighted sum of the five scores. The scale is 0 (bad) to 10 (good). A positive value indicates an improvement from baseline.|Up to 51 days|All patients who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the analysis.||units on a scale||Standard Deviation|Mean
677686|NCT01606202|Secondary|Change From Baseline in the Mean Short Orientation Memory Function Concentration Test Score at the End of Treatment|"Patients were asked at baseline and end of treatment, to complete the Short Orientation Memory Function Concentration Test as a measure of cognitive function. The minimum score is 0 and maximum of 28 which denoted good cognitive function .
A negative value from baseline indicates a deterioration."|Up to 51 days|All patients who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the analysis.||units on a scale||Standard Deviation|Mean
677687|NCT01606202|Secondary|Change From Baseline in Modified Ashworth Scale Score at the End of Treatment|The Modified Ashworth Scale is a five-point scale conducted on four pre-identified muscle groups. Only the lower limb was assessed because not all Spinal Cord Injury patients upper limb disability. The assessor used the Modified Ashworth scale ranging from 0 (“No increase in muscle tone”) to 4 (“Affected part(s) rigid in flexion or extension”) to rate the muscle tone for knee and ankle for the left and right sides separately at a pre-dose visit and at the end of treatment. The average of the four individual scores and was taken. A negative value indicates an improvement from baseline.|Up to 51 days|All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis.||units on a scale||Standard Deviation|Mean
677688|NCT01606202|Secondary|Change From Baseline in the Percentage of Days on Which Spasticity Was Experienced at the End of Treatment|Each day, just before going to bed, patients recorded in their patient diary whether they had experienced any spasticity that day or not. The percentage of days on which spasticity was experienced (spasticity incidence) was calculated and summarised analogously to the primary efficacy parameter of Numerical Rating Scale pain score. A negative value from baseline indicates an improvement.|Up to 51 days|All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis.||percentage of days||Standard Deviation|Mean
677689|NCT01606202|Secondary|Change From Baseline in Mean Spasticity Severity Numerical Rating Scale Scores the End of Treatment.|Each day at bed time patients recorded whether they experienced any spasticity that day and, if yes, the overall level of spasticity experienced was quantified using an Numerical Rating Scale from 0 = “Mildest ever spasticity” to 10 = “Worst ever spasticity”. The mean spasticity severity scores and the changes from baseline to End of Treatment were to be calculated. A negative value indicates an improvement from baseline.|0 - 51 days|All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis.||units on a scale||Standard Deviation|Mean
677690|NCT01606202|Secondary|Change From Baseline in the Percentage of Days on Which Spasm Was Experienced at the End of Treatment|Each day, just before going to bed, patients recorded in their patient diary whether they experienced any spasms that day. The percentage of days on which spasm was experienced were summarised and analysed analogously to the primary endpoint. A negative value from baseline indicates an improvement.|Up to 51 days|All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis.||percentage of days||Standard Deviation|Mean
677691|NCT01606202|Secondary|Change From Baseline in Mean Spasm Severity Numerical Rating Scale Score at the End of Treatment|Each day, just before going to bed, patients recorded in their patient diary whether they experienced any spasms that day and, if yes, recorded the overall level of the spasm(s) experienced using an Numerical Rating Scale spasm scale ranging from 0 = “Mildest ever spasm” to 10 = “Worst ever spasm”. The mean spasm severity scores were summarised and analysed analogously to the primary endpoint. A negative value from baseline indicates an improvement.|Up to 51 days|All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis.||units on a scale||Standard Deviation|Mean
677692|NCT01606202|Secondary|Change From Baseline in the Mean Percentage of Days on Which Escape Medication Was Used at the End of Treatment|The percentage of days that subjects used escape medication was analysed and is presented as the mean change from baseline at the end of treatment. A negative value from baseline indicates an improvement.|Up to 51 days|All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis.||percentage of days||Standard Deviation|Mean
677693|NCT01606202|Primary|Change From Baseline in Mean Central Neuropathic Pain 11-Point Numerical Rating Scale Scores at the End of Treatment (up to 51 Days).|The Central Neuropathic Pain Numerical Rating Scale score was recorded three times daily, in the morning (on waking), at lunchtime and in the evening using the scale, 0 = ‘No Pain’ and 10 = ‘Worst Possible Pain’. Patients were instructed to relate ‘No Pain’ to the time before the start of their spinal cord injury. End of Treatment was defined as the mean of the last seven days in the study or the mean of the last three days if the subject withdrew. A negative value indicates an improvement in pain score from baseline.|Up to 51 days|All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis.||units on a scale||Standard Deviation|Mean
677694|NCT01606189|Secondary|Incidence of Adverse Events as a Measure of Patient Safety.|The number of patients who experienced an adverse event during the course of study is presented.|Up to 114 days|All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.||participants|||Number
677728|NCT01606137|Secondary|Investigator Assessment of Benefit at the Last Study Visit in Those Experiencing Central Neuropathic Pain.|Assessment of benefit achieved at study completion/withdrawal was evaluated by the investigator, and the number of subjects that investigators considered to have experienced a benefit from the treatment is presented.|Up to 1051days|All subjects who entered the study from a neuropathic pain parent RCT and received at least one actuation of study medication were included in the efficacy analysis.||participants|||Number
677695|NCT01606189|Secondary|Change From Baseline in the Mean 12-Item General Health Questionnaire Score at the End of Each Treatment Period (Each Lasting 14-20 Days).|The 12-Item General Health Questionnaire consisted of 12 general health questions. Each question was scored on a zero to three scale, where zero represented the better assessment. The total score was the unweighted sum of the 12 scores, ranging from zero to 36. A negative value indicates an improvement from baseline.|Up to 74 days|All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.||units on a scale||Standard Deviation|Mean
677696|NCT01606189|Secondary|Change From Baseline in the Mean Pain Disability Index Score at the End of Each Treatment Period (Each Lasting 14-20 Days).|The Pain Disability Index consisted of seven assessments representing different aspects of disability due to pain. Each assessment was scored on a zero to 10 scale, where zero equated with “no disability” and 10 equated with “total disability”. The total Pain Disability Index score was the unweighted sum of the seven pain scores, ranging from zero to 70. A negative value indicates an improvement from baseline.|Up to 74 days|All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.||units on a scale||Standard Deviation|Mean
677697|NCT01606189|Secondary|Change From Baseline in the Number of Patients Who Reported 'No Pain' or 'Mild Pain' Using a McGill Pain Questionnaire Part 3 Score for 'Strength of Pain at Present' at the End of Each Treatment Period (Each Lasting 14-20 Days)|Part 3 of the questionnaire recorded the strength of pain at present. Results were recorded in six categories which were classified as “No Pain”, “Mild”, “Discomforting”, “Distressing”, “Horrible” and “Excruciating”. The change from baseline in the number of patients who reported “No Pain” or “Mild Pain” at the end of the respective treatment periods is presented. An increase in number indicates an improvement from baseline.|Up to 74 days|All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.||participants|||Number
677698|NCT01606189|Secondary|Change From Baseline in the Mean McGill Pain Questionnaire Part 2 Score for 'Intensity of Pain' at the End of Each Treatment Period (Each Lasting 14-20 Days)|Part 2 of the questionnaire recorded the intensity of pain at present. Results were recorded on a VAS ranging from zero “No pain” to 100 “Worst possible pain”. Intensity of pain was summarised and analysed in the same manner as the primary efficacy parameter of Box Scale-11 pain score. A negative value indicates an improvement from baseline.|Up to 74 days|All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.||units on a scale||Standard Deviation|Mean
677699|NCT01606189|Secondary|Change From Baseline in the Mean McGill Pain Questionnaire Part 1 Score for 'Total Pain Intensity' at the End of Each Treatment Period (Each Lasting 14-20 Days)|Part 1 of the questionnaire related to the intensity of 15 different types of pain. Intensity was recorded separately for each type of pain on a zero to three scale, where zero = “None”, one = “Mild”, two = “Moderate” and three = “Severe”. The total intensity was defined as the unweighted sum of the 15 scores, giving a minimum possible score of zero (lowest pain score) and a maximum possible score of 45 (highest pain score). The distribution of each of the 15 types of pain was summarised at baseline and for each treatment. A negative value indicates an improvement in pain from baseline.|Up to 74 days|All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.||units on a scale||Standard Deviation|Mean
677700|NCT01606189|Secondary|Change From Baseline in the Mean Box Scale-11 Sleep Quality Score at the End of Each Treatment Period (Each Lasting 14-20 Days).|Each day patients recorded in their patient diary the quality of their sleep during the previous night using a Box Scale-11 sleep score ranging from zero “Worst Imaginable” to 10 “Best Imaginable”. The treatment days and the assessment periods were defined in the same way as for the Box Scale-11 pain score. A positive value indicates an improvement from baseline.|Up to 74 days|All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.||units on a scale||Standard Deviation|Mean
677701|NCT01606189|Secondary|Change From Baseline in the Mean Sleep Disturbance Score at the End of Each Treatment Period (Each Lasting 14-20 Days).|Each day patients recorded in their patient diary the number of times they were woken due to pain during the previous night. The results were recorded as “None”, “Once”, “Twice” and “More Than Twice” and converted to a four point scale, zero to three respectively. The treatment days and the assessment periods were defined in the same way as for the Box Scale-11 pain score. A negative value indicates an improvement from baseline.|Up to 74 days|All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.||units on a scale||Standard Deviation|Mean
677702|NCT01606189|Primary|Change From Baseline in the Mean Box Scale-11 Pain Review Score at the End of Each Treatment Period (Each Lasting 14-20 Days)|Each day patients recorded in their patient diary, the severity of their pain during the previous 24 hours using a Box Scale-11 pain score ranging from zero “no pain at all” to 10 “pain as bad as you can imagine”. The Box Scale-11 pain score endpoint for each assessment period was the average of all available data recorded during the seven whole days prior to the visit immediately subsequent to that period, but only including data from Day 8 onwards. A negative value indicates an improvement in pain score from baseline.|Up to 74 days|All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.||units on a scale||Standard Deviation|Mean
677703|NCT01606176|Secondary|Incidence of Adverse Events as a Measure of Patient Safety.|The number of patients who experienced an adverse event in the study is presented.|0 - 65 days|All patients who entered the study, were randomised, received at least one dose of study medication and yielded on-treatment efficacy data were included in the safety analysis.||participants|||Number
677704|NCT01606176|Secondary|Patient Global Impression of Change - Multiple Sclerosis Subset.|The Patient Global Impression of Change consisted of a single question relating to improvement in overall condition since the start of the study. The results were recorded as “Very Much Improved”, “Much Improved”, “Minimally Improved”, “No Change”, “Minimally Worse”, “Much Worse” and “Very Much Worse” and were converted to a seven point scale ranging from one to seven, respectively. The number of patients who reported being “Very Much Improved” or “Much Improved” is presented.|0 - 3 weeks|Patients whose entry into the study was as a result of pain related to Multiple Sclerosis were included in the analysis.||participants|||Number
677796|NCT01605552|Secondary|Change in C-reactive Protein (CRP) From Pre- to Post- Treatment|A marker of systemic inflammation measured from blood samples collected at pre- and post-treatment.|0 and 12 weeks|||change in mg/L||Standard Deviation|Mean
677705|NCT01606176|Secondary|Change From Baseline in Mean Spitzer Quality of Life Index Scores (Multiple Sclerosis Subset) at 3 Weeks.|The Spitzer Quality of Life Index questionnaire consists of five sections, relating to activity, daily living, health, support and outlook. Each section has three choices (numbered 1, 2 and 3) and the patient was required to choose the one that best described their quality of life during the last week. Choice 1 is scored two, Choice 2 is scored one and Choice 3 is scored zero. The total Spitzer Quality of Life Index was calculated as the unweighted sum of the five scores. A reduction in score from baseline indicates an improvement.|0 - 3 weeks|Patients whose entry into the study was as a result of pain related to Multiple Sclerosis were included in the analysis.||units on a scale||Standard Deviation|Mean
677706|NCT01606176|Secondary|Change From Baseline in Mean Brief Pain Inventory (Short Form) Scores (Multiple Sclerosis Subset) at 3 Weeks.|The Brief Pain Inventory (Short Form) is a 14-item questionnaire that asks patients to rate pain over the prior week and the degree to which it interferes with activities on a 0 to 10 scale, where 0=no pain and 10=pain as bad as you can imagine. Severity is measured as worst pain, least pain, average pain, and pain right now. The severity composite score was calculated as the arithmetic mean of the four severity items (range 0-10). The minimum value is zero and maximum is 10. A reduction in score from baseline indicates an improvement.|0 - 3 weeks|Patients whose entry into the study was as a result of pain related to Multiple Sclerosis were included in the analysis.||units on a scale||Standard Deviation|Mean
677707|NCT01606176|Secondary|Change From Baseline in Mean Pain Disability Index Scores at 3 Weeks.|The index consists of seven assessments of pain (representing different aspects) with each assessment scored on a zero “no disability” to 10 “total disability” scale. The total Pain Disability Index was calculated as the un-weighted sum of the seven pain scores; if one or more of the pain scores were missing then the total Pain Disability Index was set to missing. A reduction in score from baseline indicates and improvement.|0 - 3 weeks|Patients whose entry into the study was as a result of pain related to Multiple Sclerosis were included in the analysis.||units on a scale||Standard Deviation|Mean
677708|NCT01606176|Secondary|Change From Baseline in Mean Sleep Disturbance Scores (Multiple Sclerosis Subset) at 3 Weeks.|Each day patients were asked to record in their patient diary, whether or not they were woken due to pain the previous night. Answers were recorded as “No”, “Once”, “Twice”, “More than twice” and “Awake most of the night”; these were converted to a five point scale, zero to four, respectively. Sleep disturbance was summarised and analysed in the same manner as the analysis of the primary efficacy parameter of Box Scale-11 pain score. A negative value from baseline indicates and improvement.|0 - 3 weeks|Patients whose entry into the study was as a result of pain related to Multiple Sclerosis were included in the analysis.||units on a scale||Standard Deviation|Mean
677709|NCT01606176|Secondary|Use of Analgesic Escape Medication - Multiple Sclerosis Subset.|The percentage of days on treatment on which escape medication was used is presented.|0 - 3 weeks|Patients whose entry into the study was as a result of pain related to Multiple Sclerosis were included in the analysis.||percentage of days||Standard Deviation|Mean
677710|NCT01606176|Secondary|Change From Baseline in Mean Pain Box Scale-11 Scores (Multiple Sclerosis Subset) at 3 Weeks.|Each day, in the morning (on waking), at lunchtime and in the evening (just before going to bed), patients recorded in their patient diary their level of pain using a Box Scale-11 pain score ranging from zero “no pain” to 10 “worst possible pain”. Week 3 analysis was defined as the mean of the last seven days in the study. The last day was taken as the last day with complete diary card pain data that occurred on or before the last day the patient took study medication. A negative value from baseline indicates and improvement.|0 - 3 weeks|Patients whose entry into the study was as a result of pain related to Multiple Sclerosis were included in the analysis.||units on a scale||Standard Deviation|Mean
677711|NCT01606176|Secondary|Patient Global Impression of Change at the End of 3 Weeks of Treatment.|The Patient Global Impression of Change consisted of a single question relating to improvement in overall condition since the start of the study. The results were recorded as “Very Much Improved”, “Much Improved”, “Minimally Improved”, “No Change”, “Minimally Worse”, “Much Worse” and “Very Much Worse” and were converted to a seven point scale ranging from one to seven, respectively. The number of patients who reported being “Very Much Improved” or “Much Improved” is presented.|0 - 3 weeks|All patients who were randomised, received at least one actuation of study medication and completed at least one set of efficacy assessments were included in the analysis.||participants|||Number
677712|NCT01606176|Secondary|Change From Baseline in Mean Spitzer Quality of Life Index Scores at 3 Weeks.|The Spitzer Quality of Life Index questionnaire consists of five sections, relating to activity, daily living, health, support and outlook. Each section has three choices (numbered 1, 2 and 3) and the patient was required to choose the one that best described their quality of life during the last week. Choice 1 is scored two, Choice 2 is scored one and Choice 3 is scored zero. The total Spitzer Quality of Life Index was calculated as the unweighted sum of the five scores. A reduction in score from baseline indicates an improvement.|0 - 3 weeks|All patients who were randomised, received at least one actuation of study medication and completed at least one set of efficacy assessments were included in the analysis.||units on a scale||Standard Deviation|Mean
677713|NCT01606176|Secondary|Change From Baseline in Mean Total Brief Pain Inventory (Short Form) Score at 3 Weeks.|The Brief Pain Inventory (Short Form) is a 14-item questionnaire that asks patients to rate pain over the prior week and the degree to which it interferes with activities on a 0 to 10 scale, where 0=no pain and 10=pain as bad as you can imagine. Severity is measured as worst pain, least pain, average pain, and pain right now. The severity composite score was calculated as the arithmetic mean of the four severity items (range 0-10). The minimum value is zero and maximum is 10. A reduction in score from baseline indicates an improvement.|0 - 3 weeks|All patients who were randomised, received at least one actuation of study medication and completed at least one set of efficacy assessments were included in the analysis.||units on a scale||Standard Deviation|Mean
677714|NCT01606176|Secondary|Change From Baseline in Mean Total Pain Disability Index Score at 3 Weeks.|The index consists of seven assessments of pain (representing different aspects) with each assessment scored on a zero “no disability” to 10 “total disability” scale. The total Pain Disability Index was calculated as the un-weighted sum of the seven pain scores; if one or more of the pain scores were missing then the total Pain Disability Index was set to missing. A reduction in score from baseline indicates and improvement.|0 - 3 weeks|All patients who were randomised, received at least one actuation of study medication and completed at least one set of efficacy assessments were included in the analysis.||units on a scale||Standard Deviation|Mean
677715|NCT01606176|Secondary|Change From Baseline in Mean Sleep Disturbance Score at 3 Weeks.|Each day patients were asked to record in their patient diary, whether or not they were woken due to pain the previous night. Answers were recorded as “No”, “Once”, “Twice”, “More than twice” and “Awake most of the night”; these were converted to a five point scale, zero to four, respectively. Sleep disturbance was summarised and analysed in the same manner as the analysis of the primary efficacy parameter of Box Scale-11 pain score. A negative value from baseline indicates and improvement.|0 - 3 weeks|All patients who were randomised, received at least one actuation of study medication and completed at least one set of efficacy assessments were included in the analysis.||units on a scale||Standard Deviation|Mean
677716|NCT01606176|Secondary|Use of Analgesic Escape Medication.|The percentage of days on treatment on which escape medication was used is presented.|0 - 3 weeks|All patients who were randomised, received at least one actuation of study medication and completed at least one set of efficacy assessments were included in the analysis.||percentage of days||Standard Deviation|Mean
677717|NCT01606176|Primary|Change From Baseline in Mean Pain Box Scale-11 Score at 3 Weeks.|Each day, in the morning (on waking), at lunchtime and in the evening (just before going to bed), patients recorded in their patient diary their level of pain using a Box Scale-11 pain score ranging from zero “no pain” to 10 “worst possible pain”. Week 3 analysis was defined as the mean of the last seven days in the study. The last day was taken as the last day with complete diary card pain data that occurred on or before the last day the patient took study medication. A negative value from baseline indicates and improvement.|0 - 3 weeks|All patients who were randomised, received at least one actuation of study medication and completed at least one set of efficacy assessments were included in the analysis.||units on a scale||Standard Deviation|Mean
677718|NCT01606150|Secondary|Premature Infant Pain Profile (PIPP) Score|PIPP score assigned by a blinded outcome assessor by viewing video tapes of the infant's face during the procedure and vital sign changes during that time frame|data collected during the procedure, PIPP score assigned within one month by viewing collected data||||||
677719|NCT01606150|Primary|Lumbar Puncture Success Rate|Success defined as cerebrospinal fluid for a culture and red blood cell count less than 1000|immediately following the procedure||||||
677720|NCT01606137|Secondary|Investigator Global Assessment at the Last Study Visit in Subjects With Multiple Sclerosis.|"Investigators rated the global severity of the subject's underlying primary condition, e.g. their MS or spinal cord injury, since the previous visit using a five point scale of much worse, worse, no change, better, much better. The number of subjects rated by the investigator as better or much better at the last study visit is presented."|Up to 1051 days.|All subjects who entered the study from a multiple sclerosis parent RCT and received at least one actuation of study medication were included in the efficacy analysis.||participants|||Number
677721|NCT01606137|Secondary|Investigator Global Assessment at the Last Study Visit in Subjects With Pain.|"Investigators rated the global severity of the subject's underlying primary condition, e.g. their MS or spinal cord injury, since the previous visit using a five point scale of much worse, worse, no change, better, much better. The number of subjects rated by the investigator as better or much better at the last study visit is presented."|Up to 1051 days.|All subjects who entered the study from a pain parent RCT and received at least one actuation of study medication were included in the efficacy analysis.||participants|||Number
677722|NCT01606137|Secondary|Investigator Global Assessment at the Last Study Visit in Subjects With Central Neuropathic Pain.|"Investigators rated the global severity of the subject's underlying primary condition, e.g. their MS or spinal cord injury, since the previous visit using a five point scale of much worse, worse, no change, better, much better. The number of subjects rated by the investigator as better or much better at the last study visit is presented."|Up to 1051 days.|All subjects who entered the study from a central neuropathic pain parent RCT and received at least one actuation of study medication were included in the efficacy analysis.||participants|||Number
677723|NCT01606137|Secondary|Investigator Global Assessment at the Last Study Visit in Subjects With Neuropathic Pain Due to Multiple Sclerosis.|"Investigators rated the global severity of the subject's underlying primary condition, e.g. their MS or spinal cord injury, since the previous visit using a five point scale of much worse, worse, no change, better, much better. The number of subjects rated by the investigator as better or much better at the last study visit is presented."|Up to 1051 days|All subjects who entered the study from a parent RCT investigation neuropathic pain due to multiple sclerosis, and who received at least one actuation of study medication were included in the efficacy analysis.||participants|||Number
677724|NCT01606137|Secondary|Investigator Assessment of Benefit at the Last Study Visit in All Multiple Sclerosis Subjects.|Assessment of benefit achieved at study completion/withdrawal was evaluated by the investigator, and the number of subjects that investigators considered to have experienced a benefit from the treatment is presented.|Up to 1051 days.|All subjects who entered the study from a multiple sclerosis parent RCT and received at least one actuation of study medication were included in the efficacy analysis.||participants|||Number
677725|NCT01606137|Secondary|Subject Assessment of Benefit at the Last Study Visit in All Multiple Sclerosis Subjects.|Assessment of benefit achieved at study completion/withdrawal was evaluated by the subject, and the number of subjects who perceived a benefit from treatment is presented.|Up to 1051 days|All subjects who entered the study from a multiple sclerosis parent RCT and received at least one actuation of study medication were included in the efficacy analysis.||participants|||Number
677726|NCT01606137|Secondary|Investigator Assessment of Benefit at the Last Study Visit in Those Experiencing Pain.|Assessment of benefit achieved at study completion/withdrawal was evaluated by the investigator, and the number of subjects that investigators considered to have experienced a benefit from the treatment is presented.|Up to 1051 days|All subjects who entered the study from a pain parent RCT and received at least one actuation of study medication were included in the efficacy analysis.||participants|||Number
677727|NCT01606137|Secondary|Subject Assessment of Benefit at the Last Study Visit in Those Experiencing Pain.|Assessment of benefit achieved at study completion/withdrawal was evaluated by the subject, and the number of subjects who perceived a benefit from treatment is presented.|Up to 1051|All subjects who entered the study from a pain parent RCT and received at least one actuation of study medication were included in the efficacy analysis.||participants|||Number
677820|NCT01605292|Other Pre-specified|Difficult Access Procedures >= 5 Attempts|Difficult procedures were defined as either requiring >= 5 attempts|Immediately during procedure (within 30 min)|||participants|||Number
677730|NCT01606137|Secondary|Investigator Assessment of Benefit at the Last Study Visit in Those Experiencing Neuropathic Pain Due to Multiple Sclerosis.|Assessment of benefit achieved at study completion/withdrawal was evaluated by the investigator, and the number of subjects that investigators considered to have experienced a benefit from the treatment is presented.|Up to 1051 days|All multiple sclerosis subjects who entered the study from a neuropathic pain parent RCT and received at least one actuation of study medication were included in the efficacy analysis.||participants|||Number
677731|NCT01606137|Secondary|Subject Assessment of Benefit at the Last Study Visit in Those Experiencing Neuropathic Pain Due to Multiple Sclerosis.|Assessment of benefit achieved at study completion/withdrawal was evaluated by the subject, and the number of subjects who perceived a benefit from treatment is presented.|Up to 1051 days|All multiple sclerosis subjects who entered the study from a neuropathic pain parent RCT and received at least one actuation of study medication were included in the efficacy analysis.||participants|||Number
677732|NCT01606137|Secondary|Change From Parent Study Baseline in Pain 0-10 Numerical Rating Scale Score at 52 Weeks of Treatment.|"Subjects were asked to rate the severity of their primary symptom each week in the diary using an 11-point Numerical Rating Scale, where zero = best possible and 10 = worst possible. A negative value indicates an improvement in score from baseline."|0 - 52 weeks.|All subjects who entered the study from a pain parent RCT and received at least one actuation of study medication were included in the efficacy analysis.||units on a scale||Standard Deviation|Mean
677733|NCT01606137|Secondary|Change From Parent Study Baseline in Neuropathic Pain 0-10 Numerical Rating Scale Score at 52 Weeks of Treatment in Multiple Sclerosis Subjects.|"Subjects were asked to rate the severity of their primary symptom each week in the diary using an 11-point Numerical Rating Scale, where zero = best possible and 10 = worst possible. A negative value indicates an improvement in score from baseline."|0 - 52 weeks.|All subjects who entered the study from a neuropathic pain in multiple sclerosis parent RCT and received at least one actuation of study medication were included in the efficacy analysis.||units on a scale||Standard Deviation|Mean
677734|NCT01606137|Secondary|Change From Parent Study Baseline in Central Neuropathic Pain 0-10 Numerical Rating Scale Score at 52 Weeks of Treatment.|"Subjects were asked to rate the severity of their primary symptom each week in the diary using an 11-point Numerical Rating Scale, where zero = best possible and 10 = worst possible. A negative value indicates an improvement in score from baseline."|0 - 52 weeks.|All subjects who entered the study from a central neuropathic pain parent RCT and received at least one actuation of study medication were included in the efficacy analysis.||units on a scale||Standard Deviation|Mean
677735|NCT01606137|Secondary|Change From Parent Study Baseline in Spasticity 0-10 Numerical Rating Scale Score After 52 Weeks of Treatment.|"Subjects were asked to rate the severity of their primary symptom each week in the diary using an 11-point Numerical Rating Scale, where zero = best possible and 10 = worst possible. A negative value indicates an improvement in score from baseline."|0 - 52 weeks|All subjects who entered the study from a parent randomised controlled trial (RCT) investigating the efficacy of GW-1000-02 in the treatment of spasticity associated with multiple sclerosis, and who received at least one actuation of study medication were included in the efficacy analysis.||units on a scale||Standard Deviation|Mean
677736|NCT01606137|Primary|Incidence of Adverse Events as a Measure of Subject Safety.|Following data entry, all adverse events were medically encoded using the Medical Dictionary for Regulatory Activities (MedDRA) 6.0. All subjects who experienced an adverse event during the treatment period is presented.|Up to 1051 days|All subjects who took part in the extension study were included in the analysis.||participants|||Number
677739|NCT01606007|Secondary|Adjusted Mean Change From Baseline in Body Weight at Week 24|Baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained at Week 24 in the doubleblind period, including observations prior to rescue.|Baseline (Week 0) and at Week 24|All randomized participants who received study medication and had nonmissing body weight values at baseline and Week 24||Body weight Kg||95% Confidence Interval|Mean
677740|NCT01606007|Secondary|Adjusted Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])|Therapeutic glycemic response is defined as HbA1c <7.0%. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.|At Week 24|All randomized participants who received study medication and were not missing baseline and Week 24 (LOCF) values||% of Participants||95% Confidence Interval|Number
677741|NCT01606007|Secondary|Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained at Week 24 in the doubleblind period, including observations prior to rescue.|Baseline (Week 0) and at Week 24|All randomized participants who received study medication and had nonmissing PPG values at baseline and Week 24||mg/dL||95% Confidence Interval|Mean
677742|NCT01606007|Secondary|Adjusted Mean Change From Baseline in 2-hour Post Prandial Glucose (PPG) From a Liquid Meal Tolerance Test (MTT) at Week 24 (Last Observation Carried Forward [LOCF])|Baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. PPG measurements were obtained at week 24 in the doubleblind period, including observations prior to rescue.|Baseline (Week 0) and at Week 24|All randomized participants who received study medication and had nonmissing PPG values at baseline and Week 24 (LOCF)||MG/DL PPG||95% Confidence Interval|Mean
681435|NCT01556906|Secondary|Absolute Change From Baseline in Aspartate Aminotransferase (AST)|Absolute change from Baseline in AST|Baseline and 16 weeks of treatment|All patients treated||U/L||Standard Deviation|Mean
677743|NCT01606007|Primary|Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24|HbA1c was measured as percent of hemoglobin by a central laboratory. Baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained at Week 24 in the double-blind period, including observations prior to rescue.|Baseline (Week 0) and at Week 24|All randomized participants who received study medication and had nonmissing HbA1c values at baseline and Week 24||% HbA1c||95% Confidence Interval|Mean
677744|NCT01605942|Secondary|Plasma Levels of Dexamethasone|Levels of dexamethasone in plasma are evaluated. Plasma is the fluid portion of the blood.|Day 2, Day 7, Day 14|Pharmacokinetic: all patients who received dexamethasone and consented to pharmacokinetic analysis.||Nanograms/Milliliter (ng/mL)||Standard Deviation|Mean
677745|NCT01605942|Primary|Number of Patients With Clearance of Anterior Chamber Inflammation|The anterior chamber is the area in front of the iris (colored part of the eye). Inflammation is measured on a scale ranging from 0 (best) to 8 (worst).|Up to Day 71|Safety: all patients who received study treatment at randomization/surgery (day 1)||Patients|||Number
677746|NCT01605916|Secondary|AUC(0-12) of Docetaxel Following Intravenous Infusion of Docetaxel 60 mg/m2|Pharmacokinetic parameter (AUC(0-12): area under the plasma concentration-time curve from zero to 12 hours post-dose) of docetaxel following intravenous infusion of docetaxel 60 mg/m2 in combination with Selumetinib|Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose|Pharmacokinetic Analysis Set||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
677747|NCT01605916|Secondary|Tmax of Docetaxel Following Intravenous Infusion of Docetaxel 60 mg/m2|Pharmacokinetic parameter (tmax: time to reach the maximum plasma concentration) of docetaxel following intravenous infusion of docetaxel 60 mg/m2 in combination with Selumetinib|Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose|Pharmacokinetic Analysis Set||hour||Full Range|Median
677748|NCT01605916|Secondary|Cmax of Docetaxel Following Intravenous Infusion of Docetaxel 60 mg/m2|Pharmacokinetic parameter (Cmax: maximum plasma concentration) of docetaxel following intravenous infusion of docetaxel 60 mg/m2 in combination with Selumetinib|Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose|Pharmacokinetic Analysis Set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
677749|NCT01605916|Primary|AUC(0-12) of N-desmethyl Selumetinib During Oral Twice Daily Dose of Selumetinib|Pharmacokinetic parameter (AUC(0-12): area under the plasma concentration-time curve from zero to 12 hours post-dose) of N-desmethyl Selumetinib during oral twice daily dose of Selumetinib|Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose|Pharmacokinetic Analysis Set||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
677750|NCT01605916|Primary|Tmax of N-desmethyl Selumetinib During Oral Twice Daily Dose of Selumetinib|Pharmacokinetic parameter (tmax: time to reach the maximum plasma concentration) of N-desmethyl Selumetinib during oral twice daily dose of Selumetinib|Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose|Pharmacokinetic Analysis Set||hour||Full Range|Median
677751|NCT01605916|Primary|Cmax of N-desmethyl Selumetinib During Oral Twice Daily Dose of Selumetinib|Pharmacokinetic parameter (Cmax: maximum plasma concentration) of N-desmethyl Selumetinib during oral twice daily dose of Selumetinib|Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose|Pharmacokinetic Analysis Set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
677752|NCT01605916|Primary|AUC(0-12) of Selumetinib During Oral Twice Daily Dose of Selumetinib|Pharmacokinetic parameter (AUC(0-12): area under the plasma concentration-time curve from zero to 12 hours post-dose) of Selumetinib during oral twice daily dose of Selumetinib|Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose|Pharmacokinetic Analysis Set||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
677753|NCT01605916|Primary|Tmax of Selumetinib During Oral Twice Daily Dose of Selumetinib|Pharmacokinetic parameter (tmax: time to reach the maximum plasma concentration) of Selumetinib during oral twice daily dose of Selumetinib|Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose|Pharmacokinetic Analysis Set||hour||Full Range|Median
677754|NCT01605916|Primary|Cmax of Selumetinib During Oral Twice Daily Dose of Selumetinib|Pharmacokinetic parameter (Cmax: maximum plasma concentration) of Selumetinib during oral twice daily dose of Selumetinib|Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose|Pharmacokinetic Analysis Set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
677755|NCT01605916|Primary|AUC(0-12) of N-desmethyl Selumetinib After Single Dose|Pharmacokinetic parameter (AUC(0-12): area under the plasma concentration-time curve from zero to 12 hours post-dose) of N-desmethyl Selumetinib following single oral dose of Selumetinib|Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose|Pharmacokinetic Analysis Set||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
677756|NCT01605916|Primary|Tmax of N-desmethyl Selumetinib After Single Dose|Pharmacokinetic parameter (tmax: time to reach the maximum plasma concentration) of N-desmethyl Selumetinib following single oral dose of Selumetinib|Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose|Pharmacokinetic Analysis Set||hour||Full Range|Median
677757|NCT01605916|Primary|Cmax of N-desmethyl Selumetinib After Single Dose|Pharmacokinetic parameter (Cmax: maximum plasma concentration) of N-desmethyl Selumetinib following single oral dose of Selumetinib|Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose|Pharmacokinetic Analysis Set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
677758|NCT01605916|Primary|AUC(0-12) of Selumetinib After Single Dose|Pharmacokinetic parameter (AUC(0-12): area under the plasma concentration-time curve from zero to 12 hours post-dosey) of Selumetinib following single oral dose of Selumetinib|Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose|Pharmacokinetic Analysis Set||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
677759|NCT01605916|Primary|Tmax of Selumetinib After Single Dose|Pharmacokinetic parameter (tmax: time to reach the maximum plasma concentration) of Selumetinib following single oral dose of Selumetinib|Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose|Pharmacokinetic Analysis Set||hour||Full Range|Median
677760|NCT01605916|Primary|Cmax of Selumetinib After Single Dose|Pharmacokinetic parameter (Cmax: maximum plasma concentration) of Selumetinib following single oral dose of Selumetinib|Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose|Pharmacokinetic Analysis Set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
677761|NCT01605877|Secondary|Percentage of Participants With Positive Response, Quality of Life Questions|"The participant completed a questionnaire, indicating (yes/no) if he/she experienced visual difficulty in every-day activities while not wearing spectacles. A positive response was defined as, Yes=visual difficulty."|Day 120-180 from second eye implantation|This analysis population includes all implanted subjects.||percentage of participants|||Number
677762|NCT01605877|Secondary|Percentage of Participants With Positive Response, Stereoscopic Vision Test|Stereopsis (the ability to perceive depth and 3-dimensional structure) was assessed binocularly under well-lit conditions at best distance using the Stereo Optical Company, Inc., Original Stereo Fly Test and polarized viewers. The participant was shown a series of symbols, with a positive response defined as correct identification of the 3-dimensional symbol. Responses were recorded for 3 symbols: Fly (easiest to perceive), animal, and circle (hardest to perceive).|Day 120-180 from second eye implantation|This analysis population includes all implanted subjects.||percentage of participants|||Number
677763|NCT01605877|Secondary|Mean Defocus Decimal VA (5 m)|Defocus VA (an indicator of the expected range of vision with a presbyopia-correcting IOL) was tested binocularly with the participant's best spectacle correction at a distance of 5 m using a chart. Lenses of different spherical powers were placed in front of the eyes to produce varying levels of defocus. The VA at each spherical power was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.|Day 120-180 from second eye implantation|This analysis population includes all implanted subjects.||decimal||Full Range|Mean
677764|NCT01605877|Secondary|Best Corrected Near (46 cm) Contrast Sensitivity|Near contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly with the participant's best spectacle correction at a distance of 46 cm using the Functional Acuity Contrast Test (FACT). Contrast sensitivity was assessed at spatial frequencies of 1.5, 3, 6, 12, and 18 cycles per degree (cpd). Raw scores were transformed to logMar units. A higher numeric value represents better contrast sensitivity.|Day 120-180 from second eye implantation|This analysis population includes all implanted subjects.||logMAR||Standard Deviation|Mean
677765|NCT01605877|Secondary|Best Corrected Far (3 m) Contrast Sensitivity|Far contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly with the participant's best spectacle correction at a distance of 3 m using the Vector Vision CSV 1000 illuminated box (one site) and the Vision Contrast Test System (other site). Contrast sensitivity was assessed at spatial frequencies of 1.5, 3, 6, 12, and 18 cycles per degree (cpd). For CSV 1000, contrast sensitivity was not measured at spatial frequency 1.5 cpd because there was no option for this frequency. Raw scores were transformed to logMar (logarithm of the minimum angle of resolution) units. A higher numeric value represents better contrast sensitivity.|Day 120-180 from second eye implantation|This analysis population includes all implanted subjects.||logMAR||Standard Deviation|Mean
677766|NCT01605877|Secondary|Mean Best Distance (cm) for Distance Corrected Decimal Near VA|VA was tested monocularly at Day 1-2, Day 7-14, Day 30-60, Day 120-180, and Day 330-420 and binocularly at Day 30-60, Day 120-180, and Day 330-420 with the participant's best spectacle correction using a chart. The participant indicated the distance (cm) at which best near vision was attained.|Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420|This analysis population includes all implanted subjects.||centimeters||Standard Deviation|Mean
677767|NCT01605877|Secondary|Mean Best Distance (cm) for Uncorrected Decimal Near VA|VA was tested monocularly at all visits and binocularly at Day 30-60, Day 120-180, and Day 330-420 unaided using a chart. The participant indicated the distance (cm) at which best near vision was attained.|Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420|"This analysis population includes all implanted subjects. Here, n is the number of participants with non-missing values at the specific time point for each arm group, respectively."||centimeters||Standard Deviation|Mean
677768|NCT01605877|Secondary|Uncorrected Decimal VA at Best Distance|VA was tested monocularly at all visits and binocularly at Day 30-60, Day 120-180, and Day 330-420 using a chart at the distance of best near vision (cm) as decided by the participant. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.|Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420|This analysis population includes all implanted subjects.||participants|||Number
677769|NCT01605877|Secondary|Distance Corrected Decimal VA (40 cm)|VA was tested binocularly using a chart. Distance-corrected VA at 40 cm is the VA at 40 cm measured under a corrected condition in which best-corrected VA at 5 m was obtained. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.|Day 120-180, Day 330-420|This analysis population includes all implanted subjects.||participants|||Number
677770|NCT01605877|Secondary|Uncorrected Decimal VA (40 cm)|VA was tested binocularly unaided at a distance of 40 cm using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.|Day 120-180, Day 330-420|This analysis population includes all implanted subjects.||participants|||Number
677771|NCT01605877|Secondary|Distance Corrected Decimal VA (1 m)|VA was tested binocularly using a chart. Distance-corrected VA at 1 m is the VA at 1 m measured under a corrected condition in which best-corrected VA at 5 m was obtained. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.|Day 120-180, Day 330-420|This analysis population includes all implanted subjects.||participants|||Number
677772|NCT01605877|Secondary|Uncorrected Decimal VA (1 m)|VA was tested binocularly unaided at a distance of 1 m using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.|Day 120-180, Day 330-420|This analysis population includes all implanted subjects.||participants|||Number
677773|NCT01605877|Primary|Distance-Corrected Decimal VA (50 cm)|VA was tested monocularly at the preoperative, Day 30-60, Day 120-180, and Day 330-420 visits and binocularly at Day 30-60, Day 120-180, and Day 330-420 using a chart. Distance-corrected VA at 50 cm is the VA at 50 cm measured under a corrected condition in which best-corrected VA at 5 m was obtained. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.|Baseline (preoperative), Day 30-60, Day 120-180, Day 330-420|This analysis population includes all implanted subjects.||participants|||Number
677774|NCT01605877|Primary|Best Corrected Decimal VA (50 cm)|VA was tested monocularly at all visits and binocularly at Day 30-60, Day 120-180, and Day 330-420 with the participant's best spectacle correction at a distance of 50 cm using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.|Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420|This analysis population includes all implanted subjects.||participants|||Number
677776|NCT01605877|Primary|Uncorrected Decimal VA (50 cm)|VA was tested monocularly at all visits and binocularly at Day 30-60, Day 120-180, and Day 330-420 unaided at a distance of 50 centimeters (cm) using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.|Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420|This analysis population includes all implanted subjects.||participants|||Number
677777|NCT01605877|Primary|Uncorrected Decimal VA (5 m)|Visual acuity (VA) was tested monocularly (each eye separately) at all visits and binocularly (both eyes together) at Day 30-60, Day 120-180, and Day 330-420 unaided at a distance of 5 meters (m) using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.|Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420|This analysis population includes all implanted subjects.||participants|||Number
677778|NCT01605825|Other Pre-specified|Hand Strength as Measured by the Grip Test and Pinch Tests||Days 1, 8, 15, 22, 29, and 36||||||
677779|NCT01605825|Other Pre-specified|Clinician Global Impression (CGI) Scale||Days 8, 15, 22, 29 and 36||||||
677780|NCT01605825|Other Pre-specified|Subject Global Impression (SGI) Scale||Days 8, 15, 22, 29 and 36||||||
677781|NCT01605825|Other Pre-specified|Assistance Required to Perform Activities of Daily Living (ADL) by the Functional Independence Measure (FIM) Scale||Days 1, 8, 15, 22, 29, and 36||||||
677782|NCT01605825|Other Pre-specified|Manual Dexterity as Measured by the Box and Block Test||Days 1, 8, 15, 22, 29, and 36||||||
677783|NCT01605825|Other Pre-specified|Motor and Sensory Function as Measured by the Fugl-Meyer Assessment (FMA)||Screening visit, Days 1, 8, 15, 22, 29, and 36||||||
677784|NCT01605825|Other Pre-specified|Walking Speed Measured by the Timed 25 Foot Walk Test (T25FW)||Screening visit, Days 1, 8, 15, 22, 29 and 36||||||
677785|NCT01605825|Primary|Safety and Tolerability of Dalfampridine-ER in Subjects With Chronic Deficits After Ischemic Stroke Assessed by Number of Treatment Emergent Adverse Events (TEAEs)|"A TEAE is defined as any adverse event with date of onset (or worsening) on or after the start-date of double-blind treatment through 7 days after the last dose of double-blind treatment.
The severity categories of mild, moderate or severe, are defined below:
Mild is defined as causing no limitation of usual activities
Moderate is defined as causing some limitation of usual activities
Severe is defined as causing inability to carry out usual activities"|up to 36 days|Safety population. Number of participants analyzed is number of patients with TEAE's as described in outcome measure description. Excludes pre-treatment and post-treatment adverse events.||participants|||Number
677786|NCT01605799|Secondary|Change in Psychological Symptoms as Measured by the Brief Symptom Inventory (BSI-53)|"The BSI is a 53 item self-report scale used to measure nine primary symptom dimensions (somatization, obsessive-compulsive behavior, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, and psychoticism). Respondents rank each feeling item (e.g., your feelings being easily hurt) on a 5-point scale ranging from 0 (not at all) to 4 (extremely). Rankings characterize the intensity of distress during the past seven days. The total score is the sum of all responses [minimum = 0 (better outcome), maximum = 212 (worse outcome)]."|The BSI will be administered at Baseline or the first study visit and the end of treatment (Week 7)|The mean change in BSI between baseline and end of treatment will be measured using an intent to treat analysis.||Units on a scale||95% Confidence Interval|Mean
677787|NCT01605799|Primary|Change in PTSD Symptoms as Measured by the PCL|The PCL is a 17 item self-report measure of the 17 symptoms of PTSD per the DSM IV. Possible scores range from 17 (better outcome) to 85 (worse outcome).|PTSD symptoms will be assessed at Baseline or the first study visit and the end of treatment (Week 7)|The mean change in PCL score from baseline to end of treatment will be measured using an intent to treat analysis.||Units on a scale||95% Confidence Interval|Mean
677788|NCT01605669|Primary|Aortic Stenosis Acceleration Index Compared to Aortic Stenosis Severity|The ASAI measures the timing of the peak intensity of the systolic murmur and compares it to the total time in systole (S2-x/s2-s1) where s1 is the first heart sound; S2 is the second heart sound and x with the time between S1 and the peak intensity of the murmur. Aortic Stenosis severity will be measured by peak and mean aortic valve gradients as well as aortic valve area derived from the continuity equation. ASAI was averaged and compared to the mean aortic gradient. ROC curve was calculated for ASAI predicting a mean gradient of >30mmHg. ASAI of 34 was determined to provide the optimal combination of specificity and sensitivity and therefore set as the cut off point for significant Aortic Stenosis.|There is a single measurement taken on the day of enrollment. The ascultatory recording and echocardiogram will occur at the same visit. There will be no additional visits or study followup.|||participants|||Number
677789|NCT01605617|Secondary|Change in Score on Overactive Bladder Questionnaire (QAB-q)|"The QAB-q is a self-administered, 33-item questionnaire containing a symptom bother and health related quality of life scale. Each item has a choice of 6 responses, ranging from not at all to a very great deal. Therefore, the total score could range from 33 (no discomfort) to 198 (great discomfort)."|Baseline, 12 weeks post treatment|The study was terminated due to a low recruitment rate prior to subjects completing treatment.|||||
677790|NCT01605617|Secondary|Number of Urgency Episodes Scored by the Indevus Urgency Severity Scale (IUSS)|The IUSS has 4 levels: none, mild, moderate, and severe. An episode characterized as severe according to this scale would qualify as an urgency episode.|baseline, 12 weeks post treatment|The study was terminated due to a low recruitment rate prior to subjects completing treatment.|||||
677791|NCT01605617|Secondary|Volume Voided Per Day||From baseline to 12 weeks post treatment|The study was terminated due to a low recruitment rate prior to subjects completing treatment.|||||
677792|NCT01605617|Secondary|Number of Voids Causing Waking||From baseline to 12 weeks post treatment|The study was terminated due to a low recruitment rate prior to subjects completing treatment.|||||
677793|NCT01605617|Secondary|Mean Change in Urinary Urge Incontinence Episodes in 24 Hours||Baseline, 12 weeks post treatment|The study was terminated due to a low recruitment rate prior to subjects completing treatment.|||||
677794|NCT01605617|Primary|Number of Urinary Voids Per 24 Hours After 12 Weeks of Therapy||From baseline to 12 weeks post treatment|The study was terminated due to a low recruitment rate prior to subjects completing treatment.|||||
677795|NCT01605552|Secondary|Change in Interleukin-6 (IL-6) From Pre- to Post- Treatment|A marker of systemic inflammation measured from blood samples collected at pre- and post-treatment.|0 and 12 weeks|One case was excluded from the usual care group due to extreme values.||change in pg/ml||Standard Deviation|Mean
677797|NCT01605552|Secondary|Change in Depressive Symptoms Severity (SCL-20 Score) From Pre- to Post- Treatment|Self-reported depressive symptom severity was measured at pre- (0 weeks) and post- (12 weeks) treatment visits by the 20 depression items from the Symptom Checklist 90 (Hopkins Symptom Checklist depression scale; SCL-20). Each item on the scale ranges from 0 (not at all) to 4 (extremely). Total scores are the average across all response items and range from 0 to 4 with higher scores indicating greater levels of depressive symptoms.|0 and 12 Weeks|One participant in the usual care group did not complete the SCL-20 at the pre-treatment visit. Therefore a change score could not be computed for this participant. The remaining number of participants in usual care for this analysis was 13.||Change in scores on a scale||Standard Deviation|Mean
677798|NCT01605552|Primary|Change in Brachial Flow-Mediated Dilation (FMD) From Pre- to Post- Treatment|Patients will undergo ultrasound assessment of brachial FMD in accordance with established guidelines. After a 10-minute supine rest, high-resolution baseline images of the brachial artery will be obtained from 3 consecutive cardiac cycles. Next, the forearm cuff will be inflated to 250 mmHg for 5 minutes and then will be rapidly deflated. At 60 and 90 seconds post-deflation, images from 3 consecutive cardiac cycles will be acquired. FMD values will be computed as the % change in brachial diameter at either 60 or 90 seconds after cuff deflation.|0 and 12 weeks|||% increase in brachial diameter||Standard Deviation|Mean
677799|NCT01605539|Secondary|Vital Signs - Temperature|"Temperature (in degrees Fahrenheit) will be monitored throughout the time course of the study and changes from baseline will be studied across the various time points.
**For test visits I, II and IV, there will be two cue sessions at each test visit: a neutral cue video (PN) and a drug-related cue video (PC) will be shown in random order at each visit. Before the beginning of each cue session (PN or PC), baseline measures will be taken. Temperature will be measured again following the neutral cue video and the drug-related cue video. Thus there will be two sets of baselines and two sets of post cue measurements per test visit for test visits I, II and IV."|Test sessions 1,2,and 4: baseline 1, post cue (PC), baseline 2, post neutral cue (PN)|||degrees F||Standard Error|Mean
677800|NCT01605539|Secondary|Vital Signs - Respiratory Rate|"Respiratory rate (in breaths/min) will be monitored throughout the time course of the study and changes from baseline will be studied across the various time points.
**For test visits I, II and IV, there will be two cue sessions at each test visit: a neutral cue video (PN) and a drug-related cue video (PC) will be shown in random order at each visit. Before the beginning of each cue session (PN or PC), baseline measures will be taken. Respiratory rate will be measured again following the neutral cue video and the drug-related cue video. Thus there will be two sets of baselines and two sets of post cue measurements per test visit for test visits I, II and IV."|Test sessions 1,2,and 4: baseline 1, post cue (PC), baseline 2, post neutral cue (PN)|||breaths per minute||Standard Error|Mean
677801|NCT01605539|Secondary|Vital Signs - Heart Rate|"Heart rate (in beats/min) will be monitored throughout the time course of the study and changes from baseline will be studied across the various time points.
**For test visits I, II and IV, there will be two cue sessions at each test visit: a neutral cue video (PN) and a drug-related cue video (PC) will be shown in random order at each visit. Before the beginning of each cue session (PN or PC), baseline measures will be taken. Heart rate will be measured again following the neutral cue video and the drug-related cue video. Thus there will be two sets of baselines and two sets of post cue measurements per test visit for test visits I, II and IV."|Test sessions 1,2,and 4: baseline 1, post cue (PC), baseline 2, post neutral cue (PN)|||beats per minute||Standard Error|Mean
677802|NCT01605539|Secondary|The Positive and Negative Affect Schedule (PANAS) - Negative Affect Schedule (NAS) Data|"Questionnaires will be used to measure subjective responses. The Positive and Negative Affect Schedule will allow us to obtain positive and negative affect measures and observe their changes from baseline over the course of the cue-induced craving session. Scale: 0 (only slightly or not at all) - 5 (extremely). Total Score Range for Negative Affect Assessment (NAS): 10 (minimum) – 50 (maximum). Higher score reflects stronger negative affect.
**For test visits I, II and IV, there will be two cue sessions at each test visit: a neutral cue video (PN) and a drug-related cue video (PC) will be shown in random order at each visit. Before the beginning of each cue session (PN or PC), baseline measures will be taken for each variable. The same variables will be measured following the neutral cue video and the drug-related cue video. Thus there will be two sets of baselines and two sets of post cue measurements per test visit for test visits I, II and IV."|Test session 1, 2, and 4: baseline 1, post cue (PC), baseline 2, post neutral cue (PN)|||units on a scale||Standard Error|Mean
677803|NCT01605539|Secondary|The Positive and Negative Affect Schedule (PANAS) - Positive Affect Schedule (PAS) Data|"Questionnaires will be used to measure subjective responses. The Positive and Negative Affect Schedule will allow us to obtain positive and negative affect measures and observe their changes from baseline over the course of the cue-induced craving session. Scale: 0 (only slightly or not at all) - 5 (extremely). Total Score Range for Positive Affect Assessment (PAS): 10 (minimum) – 50 (maximum). Higher score reflects stronger positive affect.
**For test visits I, II and IV, there will be two cue sessions at each test visit: a neutral cue video (PN) and a drug-related cue video (PC) will be shown in random order at each visit. Before the beginning of each cue session (PN or PC), baseline measures will be taken for each variable. The same variables will be measured following the neutral cue video and the drug-related cue video. Thus there will be two sets of baselines and two sets of post cue measurements per test visit for test visits I, II and IV."|Test session 1, 2, and 4: baseline 1, post cue (PC), baseline 2, post neutral cue (PN)|||units on a scale||Standard Error|Mean
677804|NCT01605539|Secondary|Visual Analog Scale for Anxiety (VASA)|"Questionnaires will be used to measure subjective responses. Anxiety will be assessed using a visual analog scale for anxiety (VASA). Scale: 0 (not at all anxious) - 10 (extremely anxious).
**For test visits I, II and IV, there will be two cue sessions at each test visit: a neutral cue video (PN) and a drug-related cue video (PC) will be shown in random order at each visit. Before the beginning of each cue session (PN or PC), baseline measures will be taken for each variable. The same variables will be measured following the neutral cue video and the drug-related cue video. Thus there will be two sets of baselines and two sets of post cue measurements per test visit for test visits I, II and IV."|Test visit I, II and IV: baseline 1, post cue (PC), baseline 2, post neutral cue (PN)|||units on a scale||Standard Error|Mean
677821|NCT01605292|Other Pre-specified|Radial Artery Spasm|Spasm defined and identified by the operator as any significant resistance or patient pain with catheter manipulation|Immediately during procedure (within 30 min)|||participants|||Number
677805|NCT01605539|Secondary|Vital Signs - Blood Pressure|"Blood pressure (mmHg) will be monitored throughout the time course of the study and changes from baseline will be studied across the various time points.
**For test visits I, II and IV, there will be two cue sessions at each test visit: a neutral cue video (PN) and a drug-related cue video (PC) will be shown in random order at each visit. Before the beginning of each cue session (PN or PC), baseline measures will be taken. Blood pressure will be measured again following the neutral cue video and the drug-related cue video. Thus there will be two sets of baselines and two sets of post cue measurements per test visit for test visits I, II and IV."|Test sessions 1,2,and 4: baseline 1, post cue (PC), baseline 2, post neutral cue (PN)|||mmHg||Standard Error|Mean
677806|NCT01605539|Primary|Changes in Out-of-Clinic Craving (From Pre-Dose to Approximately 6 Hours Post-Dose for Test Visits I and II; and From Pre-Dose Test Visit I to Pre-Cue Test Visit IV) - Via the Heroin Craving Questionnaire (HCQ)|"Subjects will be asked to complete the short version of the HCQ on their own time at home and bring it with them when they return for their next visit. Upon arrival to the clinic, subjects will also complete an HCQ with the coordinator to assess daily baseline cravings. This questionnaire will help us assess changes in craving generated outside of the clinical laboratory session from test visit 1 through test visit 4. Scale: 1 (strongly disagree) - 7 (strongly agree). Total Score Range: 14 (less cravings) - 98 (more cravings).
** The baseline measure for this outcome will be measured at the beginning of test session I prior to the administration of CBD/Placebo. Test measures will be taken approximately 6 hours following each dose for test sessions I, II and III. The final measure will be taken at test session IV, at the beginning of the session."|Test I and II: Change from pre-dose to approx. 6 hours post-dose; Change from pre-dose test visit I to pre-cue test visit IV|||units on a scale||Standard Error|Mean
677807|NCT01605539|Primary|Changes in Cue-Induced In-Clinic Craving (From Baseline to Post-cue or Post-neutral - Via the Visual Analog Scale for Craving (VASC)|"The VASC will be administered to assess potential variations in the subjective craving effects associated with heroin. Following the administration of the investigational drug, craving induced in response to the cue sessions and neutral cue sessions in the clinic will be measured. In this way, changes in craving from baseline (pre-cue to post-cue and pre-neutral cue to post-neutral cue) within each test visit) will be measured and compared. Scale range: 0 (no craving) - 10 (extreme craving).
**For test visits I, II and IV, there will be two cue sessions at each test visit: a neutral cue video (PN) and a drug-related cue video (PC) will be shown in random order at each visit. Before the beginning of each cue session (PN or PC), baseline measures will be taken. The same questionnaires will be administered immediately following the neutral cue video and the drug-related cue video. Thus there will be two sets of baselines and two sets of post cue measurements per test visit for test"|VASC: test visits I, II and IV - baseline 1, post cue (PC), baseline 2, post neutral cue (PN)|||units on a scale||Standard Error|Mean
677808|NCT01605461|Primary|Excretion of Total [14C]-Radioactivity in Faeces|Excretion of total [14C]-radioactivity in faeces|Before drug administration (24hours (h) to 15 minutes pre-dose) and 0h-24h, 24h-48h, 48h-72h, 72h-96h, 96h-120h, 120h-144h, 144h-168h, 168h-192h and 192h-216h after drug administration|PK set||Percentage of radioactive dose recovered||Geometric Coefficient of Variation|Geometric Mean
677809|NCT01605461|Primary|Excretion of Total [14C]-Radioactivity in Urine|Excretion of total [14C]-radioactivity in urine|Before drug administration (24hours (h) to 15 minutes pre-dose) and 0h-24h, 24h-48h, 48h-72h, 72h-96h, 96h-120h, 120h-144h, 144h-168h, 168h-192h and 192h-216h after drug administration|PK set||Percentage of radioactive dose recovered||Geometric Coefficient of Variation|Geometric Mean
677810|NCT01605461|Primary|Excretion Balance of Total [14C]-Radioactivity|Excretion balance of total [14C]-radioactivity (urine and faeces)|Before drug administration (24hours (h) to 15 minutes pre-dose) and 0h-24h, 24h-48h, 48h-72h, 72h-96h, 96h-120h, 120h-144h, 144h-168h, 168h-192h and 192h-216h after drug administration|PK set||Percentage of radioactive dose recovered||Geometric Coefficient of Variation|Geometric Mean
677811|NCT01605461|Primary|t1/2 of [14C]-Radioactivity in Plasma|Terminal half life (T1/2) of [14C]-radioactivity in plasma|15 minutes (min) before drug administration and 30min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 15h, 24h, 36h, 48h, 72h and 96h after drug administration|PK set||hours||Geometric Coefficient of Variation|Geometric Mean
677812|NCT01605461|Primary|Cmax of Plasma Deleobuvir|Maximum measured concentration (Cmax) of plasma deleobuvir|15 minutes (min) before drug administration and 30min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 15h, 24h, 36h, 48h, 72h and 96h after drug administration|PK set||nmol/L||Geometric Coefficient of Variation|Geometric Mean
677813|NCT01605461|Primary|AUC0-infinity of Plasma Deleobuvir|Area under the plasma deleobuvir concentration-time curve over the time interval from 0 h extrapolated to infinity (AUC0-infinity)|15 minutes (min) before drug administration and 30min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 15h, 24h, 36h, 48h, 72h and 96h after drug administration|Pharmacokinetic analysis set (PK set) which included all subjects in the treated set who provided at least 1 observation for at least 1 primary PK endpoint without important protocol violations relevant to the evaluation of PK.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
677814|NCT01605370|Primary|Change in Inappropriate Left Ventricular Mass (LVM)|LVM will be measured by echocardiography exam. LVM is inappropriate when observed LVM (oLVM) exceeds predicted LVM (pLVM) by more than 28%, that is, 100×(oLVM/pLVM) >128%.|baseline, 6 months|Data were not collected for the single participant, so no analysis was performed.|||||
677815|NCT01605292|Other Pre-specified|Pain Score|Patient-reported wrist pain using a visual-analogue scale (0-10) 2-8 hours after the procedure, where 0 is no pain and 10 is severe pain.|2-8 hours after procedure|||units on a scale||Inter-Quartile Range|Median
677816|NCT01605292|Post-Hoc|Failure of Radial Sheath Insertion With Original Randomized Technique||Immediate|||participants|||Number
677817|NCT01605292|Post-Hoc|Crossover to Ultrasound Rescue Attempts After 5 Minutes|Patients randomized to palpation-guided access could have their procedure changed to ultrasound at operator discretion after 5 minutes of palpation-guided attempts.|5 minutes|Only patients randomized to palpation could potentially cross over to ultrasound technique.||participants|||Number
677818|NCT01605292|Other Pre-specified|Bleeding Complication|Any hematoma >2 cm or bleeding requiring intervention|After procedure (within 24 hours)|||participants|||Number
677819|NCT01605292|Other Pre-specified|Difficult Access >= 5 Minutes|Access that requires >= 5 minutes from first attempt to sheath insertion|Immediate (within 30 minutes)|||participants|||Number
677824|NCT01605292|Primary|Number of Attempts|Number of passes of the needle required to access the artery during the cardiac catheterization procedure. This is only assessed at the time of the procedure, i.e. during the first 30 minutes. This is to be reported as both total number of attempts and as a first pass success rate.|Immediately during procedure. (up to 30 minutes)|473 patients of 698 had number of attempts measured correctly by number of forward passes. This subgroup of the whole population was used for analysis of number of attempts.||forward attempts||Standard Deviation|Mean
677825|NCT01604941|Secondary|Number of Participants Classified as a Responder by Serum Ferritin|A responder was defined as a participant whose observed serum ferritin level at the measured time point was less than the baseline value. Serum ferritin levels were determined from serum biochemistry analyses.|8 and 16 weeks|The Full Analysis Set, defined as all participants in the Safety Set who had at least 1 post-baseline primary efficacy assessment. The Safety Set was defined as all participants who had taken at least 1 BID dose of investigational product.||participants|||Number
677826|NCT01604941|Secondary|Number of Participants Classified as a Responder by R2* MRI Analysis of LIC Adjusted For Transfusional Iron Intake|A responder was defined as a participant whose observed liver iron concentration (LIC) at the measured time point was less than the baseline value. LIC was assessed by abdominal MRI with the R2* according to standard procedures (liver and pancreas), and the results were adjusted for transfusional iron intake. Early Termination was within the protocol defined visit date +/- 14 days window and was mapped to next scheduled MRI visit for 3 participants. For participants who had a blood transfusion on the MRI exam date, the blood transfusion done immediately prior to the MRI exam date was included in the calculation of daily transfusion intake.|12 and 24 weeks|The Full Analysis Set, defined as all participants in the Safety Set who had at least 1 post-baseline primary efficacy assessment. The Safety Set was defined as all participants who had taken at least 1 BID dose of investigational product.||participants|||Number
677827|NCT01604941|Secondary|Number of Participants Classified as a Responder by R2* MRI Analysis of LIC|A responder was defined as a participant whose observed liver iron concentration (LIC) at the measured time point was less than the baseline value. LIC was assessed by abdominal MRI with the R2* according to standard procedures (liver and pancreas). Early Termination was within the protocol defined visit date +/- 14 days window and was mapped to next scheduled MRI visit for 3 participants.|12 and 24 weeks|The Full Analysis Set, defined as all participants in the Safety Set who had at least 1 post-baseline primary efficacy assessment. The Safety Set was defined as all participants who had taken at least 1 BID dose of investigational product.||participants|||Number
677828|NCT01604941|Secondary|Number of Participants Classified as a Responder by FerriScan R2 MRI Analysis of LIC Adjusted For Transfusional Iron Intake|A responder was defined as a participant whose observed liver iron concentration (LIC) at the measured time point was less than the baseline value. LIC was assessed by abdominal MRI with the FerriScan R2 according to standard procedures, and the results were adjusted for transfusional iron intake. Early Termination was within the protocol defined visit date +/- 14 days window and was mapped to next scheduled MRI visit for 3 participants. For participants who had a blood transfusion on the MRI exam date, the blood transfusion done immediately prior to the MRI exam date was included in the calculation of daily transfusion intake.|12 and 24 weeks|The Full Analysis Set, defined as all participants in the Safety Set who had at least 1 post-baseline primary efficacy assessment. The Safety Set was defined as all participants who had taken at least 1 BID dose of investigational product.||participants|||Number
677829|NCT01604941|Secondary|Number of Participants Classified as a Responder by FerriScan R2 MRI Analysis of LIC|A responder was defined as a participant whose observed liver iron concentration (LIC) at the measured time point was less than the baseline value. LIC was assessed by abdominal MRI with the FerriScan R2 according to standard procedures. Early Termination was within the protocol defined visit date +/- 14 days window and was mapped to next scheduled MRI visit for 3 participants.|12 and 24 weeks|The Full Analysis Set, defined as all participants in the Safety Set who had at least 1 post-baseline primary efficacy assessment. The Safety Set was defined as all participants who had taken at least 1 BID dose of investigational product.||participants|||Number
677830|NCT01604941|Primary|Change From Baseline in LIC Adjusted by Transfusional Iron Intake And Assessed by FerriScan R2 MRI|The efficacy of SPD602 was assessed by determining LIC and adjusting for transfusional iron intake. Abdominal MRI data were collected by using FerriScan R2 standard procedures and used to determine LIC. A negative change from baseline indicates that LIC decreased. For participants who had a blood transfusion on the MRI exam date, the blood transfusion done immediately prior to the MRI exam date was included in the calculation of daily transfusion intake. Early Termination was within the protocol defined visit date +/- 14 days window and was mapped to next scheduled MRI visit for 3 participants.|Baseline, 12 and 24 weeks|The Full Analysis Set, defined as all participants in the Safety Set who had at least 1 post-baseline primary efficacy assessment. The Safety Set was defined as all participants who had taken at least 1 BID dose of investigational product.||mg Fe/g*dw||Standard Deviation|Mean
677831|NCT01604941|Secondary|Change From Baseline in Serum Ferritin|Serum ferritin levels were determined from serum biochemistry analyses. A negative change from baseline indicates that serum ferritin decreased.|Baseline, 8 and 16 weeks|The Full Analysis Set, defined as all participants in the Safety Set who had at least 1 post-baseline primary efficacy assessment. The Safety Set was defined as all participants who had taken at least 1 BID dose of investigational product.||ng/mL||Standard Deviation|Mean
677832|NCT01604941|Secondary|Change From Baseline in Cardiac T2* Relaxation Rate, an MRI Parameter Used to Estimate Cardiac Iron Load|The efficacy of SPD602 was assessed by estimating cardiac iron load. T2* data from cardiac MRI were collected by using standard procedures and used as an estimate of cardiac iron load. T2* is an MR relaxation parameter that is reported in milliseconds. Iron within a tissue decreases homogeneity of the magnetic field and shortens the T2* relaxation rate (Anderson, 2001). Low cardiac T2* values are associated with increased risk of heart failure (Kirk, 2009). A negative change from baseline in the T2* relaxation rate indicates that iron load increased. Early Termination was within the protocol defined visit date +/- 14 days window and was mapped to next scheduled MRI visit for 3 participants.|Baseline, 12 and 24 weeks|The Full Analysis Set, defined as all participants in the Safety Set who had at least 1 post-baseline primary efficacy assessment. The Safety Set was defined as all participants who had taken at least 1 BID dose of investigational product.||milliseconds||Standard Deviation|Mean
681436|NCT01556906|Secondary|Absolute Change From Baseline in Alanine Aminotransferase (ALT)|Absolute change from Baseline in ALT|Baseline and 16 weeks of treatment|All patients treated||U/L||Standard Deviation|Mean
677833|NCT01604941|Secondary|Change From Baseline in LIC Adjusted by Transfusional Iron Intake And Assessed by R2* MRI|The efficacy of SPD602 was assessed by determining LIC and adjusting for transfusional iron intake. Abdominal MRI data were collected by using R2* standard procedures (liver and pancreas) and used to determine LIC. A negative change from baseline indicates that LIC decreased. For participants who had a blood transfusion on the MRI exam date, the blood transfusion done immediately prior to the MRI exam date was included in the calculation of daily transfusion intake. Early Termination was within the protocol defined visit date +/- 14 days window and was mapped to next scheduled MRI visit for 3 participants.|Baseline, 12 and 24 weeks|The Full Analysis Set, defined as all participants in the Safety Set who had at least 1 post-baseline primary efficacy assessment. The Safety Set was defined as all participants who had taken at least 1 BID dose of investigational product.||mg Fe/g*dw||Standard Deviation|Mean
677834|NCT01604941|Secondary|Change From Baseline in LIC as Assessed by R2* MRI|The efficacy of SPD602 was assessed by determining LIC. Abdominal MRI data were collected by using R2* standard procedures (liver and pancreas) and used to determine LIC. A negative change from baseline indicates that LIC decreased. Early Termination was within the protocol defined visit date +/- 14 days window and was mapped to next scheduled MRI visit for 3 participants.|Baseline, 12 and 24 weeks|The Full Analysis Set, defined as all participants in the Safety Set who had at least 1 post-baseline primary efficacy assessment. The Safety Set was defined as all participants who had taken at least 1 BID dose of investigational product.||mg Fe/g*dw||Standard Deviation|Mean
677835|NCT01604941|Primary|Change From Baseline in Liver Iron Concentration (LIC) as Assessed by FerriScan R2 Magnetic Resonance Imaging (MRI)|The efficacy of SPD602 was assessed by determining LIC. Abdominal MRI data were collected by using FerriScan R2 standard procedures and used to determine LIC. A negative change from baseline indicates that LIC decreased. Early Termination was within the protocol defined visit date +/- 14 days window and was mapped to next scheduled MRI visit for 3 participants.|Baseline, 12 and 24 weeks|The Full Analysis Set, defined as all participants in the Safety Set who had at least 1 post-baseline primary efficacy assessment. The Safety Set was defined as all participants who had taken at least 1 BID dose of investigational product.||mg Fe/g*dw||Standard Deviation|Mean
677836|NCT01604850|Secondary|Percentage of Participants With Viral Relapse|"Viral relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement.
For the purposes of this efficacy analysis, the posttreatment period began after the end of active treatment (following Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm)."|End of treatment to posttreatment Week 24|The Full Analysis Set included all participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug.||participants|||Number
677837|NCT01604850|Secondary|Percentage of Participants With Viral Breakthrough|"Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment, confirmed with 2 consecutive values (second confirmation value could be posttreatment), or last available on-treatment measurement with no subsequent follow-up values.
For the purposes of this efficacy analysis, assessments were made during active treatment (up to Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm)."|Up to 16 weeks|The Full Analysis Set included all participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug.||percentage of participants|||Number
677838|NCT01604850|Secondary|Percentage of Participants Achieving SVR24|"SVR24 was defined as HCV RNA < LLOQ 24 weeks after cessation of therapy.
For the purposes of this efficacy analysis, the posttreatment period began after the end of active treatment (following Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm)."|Posttreatment Week 24|The Full Analysis Set included all participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug.||percentage of participants|||Number
677839|NCT01604850|Secondary|Percentage of Participants Achieving SVR4|"SVR4 was defined as HCV RNA < LLOQ 4 weeks after cessation of therapy.
For the purposes of this efficacy analysis, the posttreatment period began after the end of active treatment (following Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm)."|Posttreatment Week 4|The Full Analysis Set included all participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug.||percentage of participants|||Number
677840|NCT01604850|Primary|Adverse Events Leading to Permanent Discontinuation of Study Drug|Adverse events which led to permanent discontinuation of study drug may or may not have been related to study treatment.|Baseline to Week 16|The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.||participants|||Number
677841|NCT01604850|Primary|Percentage of Participants Achieving SVR12|"SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ, ie, < 25 IU/mL) 12 weeks after cessation of therapy.
For the purposes of this efficacy analysis, the posttreatment period began after the end of active treatment (following Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm)."|Posttreatment Week 12|The Full Analysis Set included all participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug.||percentage of participants|||Number
677842|NCT01604772|Secondary|Incidence of Toxicities of Akt Inhibitor MK-2206|Safety will be assessed in terms of the number of participants reporting grade 3 or higher adverse events as evaluated by Common Terminology Criteria for Adverse Events v4.0 (CTCAE).|Time to first treatment to up to 30 days after completion of treatment||||||
677843|NCT01604772|Secondary|Overall Survival|Overall Survival is defined as the time from registration to death. The distribution of survival will be estimated using the method of Kaplan-MeierEstimated using Kaplan-Meier methodology.|Time of study entry to death due to any cause, assessed up to 3 years from registration|This endpoint has not been assessed yet.|||||
677844|NCT01604772|Secondary|Median Progression Free Survival|Progression Free Survival is defined as the time from registration to the earliest date of documentation of disease progression or death. The distribution of time to progression will be estimated using the method of Kaplan-Meier.|Time of study entry to progression or death, up to 3 years after registration|Two patients were deemed ineligible and were not included in this endpoint.||months||95% Confidence Interval|Median
678124|NCT01601236|Other Pre-specified|Change in Mean HbA1c|Change from baseline mean HbA1c (%) to Week 36|Week 36|This trial had an adaptive design that pre-specified the closure of the 32 U arm (Group 5) in the event Acthar was not well tolerated at that dose. Based on tolerability, all patients initially included in the 32 U arm were combined with the 16 U arm (Group 3).||%HbA1c||Standard Deviation|Mean
677845|NCT01604772|Primary|Confirmed Response Rate (Complete Response + Partial Response) According to RECIST Version 1.1|"Confirmed response rate will be reported as the number of participants achieving either a complete response or partial response (using RECIST v1.1) divided by the number of evaluable participants. In order for a participant to be a confirmed objective responder, they must achieve a PR or CR on consecutive evaluations, at least 4 weeks apart.
Complete Response (CR): Disappearance of all target lesions and normalization of tumor biomarkers.
Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD."|Up to 32 weeks|Two patients were deemed ineligible for this endpoint due to eligibility criteria not being met. Therefore, this endpoint is reported using 14 eligible patients.||percentage of patients||95% Confidence Interval|Number
677846|NCT01604278|Secondary|Number of Participants With Adverse Events and Serious Adverse Events|All study emergent adverse events including Chronic Obstructive Pulmonary Disease exacerbations were monitored from screening through the end of study.|12 weeks|Safety Set: The safety set included all patients who received at least one dose of study drug whether or not they were randomized.||Number of participants|||Number
677847|NCT01604278|Secondary|Change From Baseline in Mean Daily Total and Individual Symptom Scores|The symptoms (respiratory, cough, wheeze, sputum color, sputum production, breathlessness, sore throat, nasal discharge or congestion, and fever) for the whole active treatment period was analyzed using a mixed model, which contained treatment, baseline smoking status and baseline ICS use as fixed effects with the baseline symptom score, FEV1 prior to inhalation of short acting bronchodilators and FEV1 post inhalation of short acting bronchodilators as covariates and center nested in region as a random effect. Each symptom was scored as 0, 1, 2 or 3 where the description for each score varied. For each of the symptoms, the range of scores from 0 to 3 represented an increase in symptoms where 0 represented little to no symptom and 3 represented severe or worst symptom. The total symptom score, which is the sum of the individual scores, ranged from 0 (best possible outcome) to 27 (worst possible outcome).|Baseline, 12 weeks|Only participants from the full analysis set, who had outcome measure data with applicable fixed effects/covariates according to the analysis model, were analyzed.||Score||Standard Error|Least Squares Mean
677848|NCT01604278|Secondary|Transitional Dyspnea Index (TDI) Focal Score|Dyspnea was measured at baseline using the Baseline Dyspnea Index (BDI) and during treatment using the Transitional Dyspnea Index (TDI). Analysis was done via mixed model. The BDI and TDI each have three domains: functional impairment, magnitude of task and magnitude of effort. BDI domains were rated from 0 (severe) to 4 (unimpaired) and rates summed for baseline focal score ranged from 0 to 12; lower scores mean worse severity. TDI domains were rated from -3 (major deterioration) to 3 (major improvement) and rates summed for transition focal score ranged from -9 to 9; negative scores indicate deterioration. A TDI focal score of 1 is considered a minimal clinically important difference.|baseline, 12 weeks|Only participants from the full analysis set, who had outcome measure data with applicable fixed effects/covariates according to the analysis model, were analyzed.||Score||Standard Error|Least Squares Mean
677849|NCT01604278|Secondary|Change From Baseline in Mean Daily Number of Puffs of Rescue Medication|The number of puffs of rescue medication taken in the previous 12 hours was recorded in the patient diary in the morning and evening. The total number of puffs of rescue medication per day over the whole active treatment period was calculated and divided by the total number of days with non-missing rescue data to derive the mean daily number of puffs of rescue medication taken for the patient. If the number of puffs was missing for part of the day (either morning or evening), then a half day was used in the denominator.|Baseline, 12 weeks|Only participants from the full analysis set, who had outcome measure data with applicable fixed effects/covariates according to the analysis model, were analyzed.||Number of puffs||Standard Error|Least Squares Mean
677850|NCT01604278|Secondary|Inspiratory Capacity (IC) at Individual Time-points|Inspiratory Capacity (IC) was measured at 20 min pre-dose and at post-dose at 25 minutes, 1 hour 55 minutes, 3 hours 55 minutes and 23 hours 40 minutes, by visit. The model contained treatment, baseline smoking status and baseline ICS use as fixed effects with the baseline measurement of IC, FEV1 prior to inhalation of short acting bronchodilators and FEV1 post inhalation of short acting bronchodilators as covariates and center nested in region as a random effect. IC measurements within 6 hours of rescue medication use or within 7 days of systemic corticosteroid use were set to missing.|Day 1, Days 84/85|Only participants from the full analysis set, who had outcome measure data with applicable fixed effects/covariates according to the analysis model, were analyzed.||Liters||Standard Error|Least Squares Mean
677851|NCT01604278|Secondary|Forced Vital Capacity (FVC) at Individual Time-points|FVC was calculated at each time point up to 4 hours post-dose and at 23 hours 15 minutes and 23 hours 45 minutes, by visit. The model contained treatment, baseline smoking status and baseline ICS use as fixed effects with the baseline measurement of FVC, FEV1 prior to inhaltion of short acting bronchodilators and FEV1 post inhaltion of short acting bronchodilators as covariates and center nested in region as a random effect. FVC measurements within 6 hours of rescue medication use or within 7 days of systemic corticosteroid use were set to missing.|Day 1, Day 29, Day 57 and Days 84/85|Only participants from the full analysis set, who had outcome measure data with applicable fixed effects/covariates according to the analysis model, were analyzed.||Liters||Standard Error|Least Squares Mean
677852|NCT01604278|Secondary|FEV1 at Individual Time-points|Centralized spirometry according to internationally accepted standards was used. FEV1 was measured at all post-dose time points up to 4 hours, and at 23 hours 15 minutes and 23 hours 45 minutes, by visit. The model contained treatment, baseline smoking status and baseline ICS use as fixed effects with the baseline measurement of FEV1, FEV1 prior to inhaltion of short acting bronchodilators and FEV1 post inhaltion of short acting bronchodilators as covariates and center nested in region as a random effect. FEV1 measurements within 6 hours of rescue medication use or within 7 days of systemic corticosteroid use were not included in the analysis.|Day 1, Day 29, Day 57 and Days 84/85|Full Analysis Set||Liters||Standard Error|Least Squares Mean
677862|NCT01604265|Secondary|Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for 'Word List Generation' at the End of Treatment (4 Weeks)|Word list generation measures verbal associative fluency. Patients are given 60 seconds to give as many words beginning with a particular letter. The Total is the unweighted sum of all admissible words over three different trials. Higher scores indicate a better cognitive performance (min=0, max= not defined).|0 - 4 weeks|All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.||number of words||Standard Deviation|Mean
677853|NCT01604278|Secondary|Peak FEV1 During 30 Minutes to 4 Hours Post-dose at 12 Weeks|Centralized spirometry was used according to internationally accepted standards was used. Peak FEV1 was defined as the maximum FEV1 during the first 4 hours post morning dosing. The model contained treatment, baseline smoking status and baseline ICS use as fixed effects with the baseline measurement of FEV1, FEV1 prior to inhalation of short acting bronchodilators and FEV1 post inhalation of short acting bronchodilator as covariates and center nested in a region as a random effect. If all FEV1 measurements were missing from 30 minutes onward, the peak FEV1 was not calculated. FEV1 measurements within 6 hours of rescue medication use or within 7 days of systemic corticosteroid use were not included in the analysis.|12 weeks|Only participants from the full analysis set, who had outcome measure data with applicable fixed effects/covariates according to the analysis model, were analyzed.||Liters||Standard Error|Least Squares Mean
677854|NCT01604278|Secondary|FEV(1) Area Under the Curve (AUC) During 30 Minutes to 4 Hours Post Dose|Centralized spirometry was used according to internationally accepted standards was used. The trapezoidal rule was applied to calculate FEV1 Area Under the Curve (AUC) and then normalized to the length of time. Whether the participants had complete or incomplete FEV1 assessments in respective time ranges, their AUCs were calculated based on the existing FEV1 measurements (i.e., the missing FEV1 measurements were not interpolated). Specifically, for those participants who had a FEV1 assessment at only one time-point, their AUC was approximated by the observed FEV1. FEV1 measurements within 6 hours of rescue medication use or within 7 days of systemic corticosteroid use were not included in the analysis.|12 weeks|Only participants from the full analysis set, who had outcome measure data with applicable fixed effects/covariates according to the analysis model, were analyzed.||Liters||Standard Error|Least Squares Mean
677855|NCT01604278|Primary|Trough Forced Expiratory Volume at 1 Second (FEV1)|Centralized spirometry according to internationally accepted standards was used. The model contained treatment, baseline smoking status and baseline inhaled corticosteroid (ICS) use as fixed effects with the baseline measurement of FEV1, FEV1 prior to inhalation of short acting bronchodilators and FEV1 post inhalation of short acting bronchodilator as covariates and center nested in region as a random effect. If trough FEV1 was missing at week 12, the latest non-missing pre-dose trough FEV1 (the mean of 45 and 15 min pre-dose measurements) from day 29, 57 or 84) was carried forward. These measurements had to have been taken before the next dose of study medication. FEV1 measurements within 6 hours of rescue medication use or within 7 days of systemic corticosteroid use were not included in the analysis.|12 weeks|Only participants from the full analysis set, who had outcome measure data with applicable fixed effects/covariates according to the analysis model, were analyzed.||Liters||Standard Error|Least Squares Mean
677856|NCT01604265|Secondary|Incidence of Adverse Events as a Measure of Patient Safety.|The number of patients who experienced an adverse event during the course of the study is presented.|0 - 4 weeks|All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.||participants|||Number
677857|NCT01604265|Secondary|Change From Baseline in the Multiple Sclerosis Functional Composite Score at the End of Treatment (4 Weeks)|The Multiple Sclerosis Functional Composite test is a three-part, standardized, quantitative, assessment instrument for use in clinical studies. The three components of the test measure leg function/ambulation, arm/hand function, and cognitive function. An increase in score indicates an improvement (range -3 to +3).|Baseline to end of treatment (0 - 4 weeks).|All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.||units on a scale||Standard Deviation|Mean
677858|NCT01604265|Secondary|Change From Baseline in The Hospital Anxiety and Depression Scale Score for Anxiety at the End of Treatment (4 Weeks)|Depression and anxiety was assessed using The Hospital Anxiety and Depression Scale. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 giving a total score between 0 and 21 for either anxiety or depression. A reduction in score indicates an improvement. The change from baseline in the overall anxiety score at the end of treatment is presented.|0 - 4 weeks|All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.||units on a scale||Standard Deviation|Mean
677859|NCT01604265|Secondary|Change From Baseline in The Hospital Anxiety and Depression Scale Score for Depression at the End of Treatment (4 Weeks)|Depression and anxiety was assessed using The Hospital Anxiety and Depression Scale. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 giving a total score between 0 and 21 for either anxiety or depression. A reduction in score indicates an improvement. The change from baseline in the overall depression score at the end of treatment is presented.|0 - 4 weeks|All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.||units on a scale||Standard Deviation|Mean
677860|NCT01604265|Secondary|Change From Baseline in the Mean 0-100 mm Visual Analogue Scale Score for Intoxication Levels at the End of Treatment (4 Weeks)|Intoxication levels were recorded on a Visual Analogue Scale, where zero equated with “no intoxication” and 100 equated with “extreme intoxication”. A decrease in baseline score indicates a reduction in intoxication.|0 - 4 weeks|All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.||units on a scale||Standard Deviation|Mean
677861|NCT01604265|Secondary|Change From Baseline in the Mean Total Guy’s Neurological Disability Scale Score at the End of Treatment (4 Weeks)|The Guy's Neurological Disability Scale has 12 separate categories which include cognition, mood, vision, speech, swallowing, upper limb function, lower limb function, bladder function, bowel function, sexual function, fatigue, and 'others'. Each category consists of a series of questions, which are scored on a 0 to 5 scale, with 0 being indicative of a better outcome and 5 being indicative of a worse outcome. The total Guy’s Neurological Disability Scale score is the unweighted sum from the 12 categories with a minimum score of 0 and maximum of 60. A negative value indicates an improvement in score from baseline.|0 - 4 weeks|All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.||units on a scale||Standard Deviation|Mean
677905|NCT01603940|Secondary|Vascular Stiffness|Access vascular stiffness by pulse wave velocity and compare it between groups (losartan and benazepril).|12 weeks.|||m/s||Inter-Quartile Range|Median
677863|NCT01604265|Secondary|Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for the 'Paced Auditory Serial Addition Task' (PASAT) at the End of Treatment (Week 4)|The Paced Auditory Serial Addition Task assesses sustained attention and concentration. A pre-recorded tape is used to present two series of 60 numbers, one every 3 seconds and one every 2 seconds. Patients are asked to add each number to the one immediately preceding it and give the result. The task summary score is the percentage of correct answers is calculated. The PASAT score range was 0% to 100%. Higher scores indicate a better cognitive performance.|0 - 4 weeks|All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.||percentage of correct answers||Standard Deviation|Mean
677864|NCT01604265|Secondary|Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for 'Symbol Digit Modalities' at the End of Treatment (Week 4)|The Symbol Digit Modalities Test measures complex attention and concentration in a task which also requires speed and accuracy in visual search and scanning. Patients are required to associate symbols with numbers and quickly generate the number when shown the symbol. The summary endpoint is the number of correct responses in 90 seconds. The symbol digit modalities test had a min of 0 and max score of 99. A higher score indicates better cognitive performance.|0 - 4 weeks|All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.||units on a scale||Standard Deviation|Mean
677865|NCT01604265|Secondary|Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for '10/36 Spatial Recall' at the End of Treatment (Week 4)|The 10/36 Spatial Recall Test assesses visual spatial learning and delayed recall. Patients are asked to view a 6 x 6 checkerboard with ten checkers for 10 seconds. They are then asked to recreate the pattern viewed on a blank checkerboard. The number of correct responses from three immediate trials and one delayed trial (7 minute delay) are recorded. The Total number of correct responses is the unweighted sum from the four trials. The score for the 10/36 spatial recall test was the unweighted average of four individual study results (min=0 and max=40). A higher score indicates better cognitive performance.|Weeks 0 - 4|All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.||units on a scale||Standard Deviation|Mean
677866|NCT01604265|Secondary|Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for 'Selective Reminding' at the End of Treatment (Week 4)|The Selective Reminding Test measures verbal learning and delayed recall through a multiple-trial list-learning paradigm. Patients are presented aurally with a list of 12 words for trial 1 and are asked to recall as many as possible. For trials 2-6, there is a selective presentation of only those words not recalled on the previous trial. Trial 7 is similar to the other trials but is assessed after an 11-minute delay. The score for the selective reminding test is the unweighted average of seven individual study results (min=0 and max=84) Higher scores indicate a better cognitive performance.|Baseline to end of study (0 - 4 weeks)|All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.||units on a scale||Standard Deviation|Mean
677867|NCT01604265|Secondary|Change From Baseline in the Mean Neuropathic Pain Scale 0-10 Numerical Rating Scale Score at the End of Treatment (Week 4)|The Neuropathic Pain Scale score is the 0-100 sum of 10 individual pain scores (0-10 Numerical Rating Scale, 0= no pain to 10 = worst pain imaginable). A negative change from baseline indicates an improvement in pain.|Baseline to end of treatment (0 - 4 weeks).|All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.||units on a scale||Standard Deviation|Mean
677868|NCT01604265|Secondary|Subject Global Impression of Change at Week 4|A 7-point Likert-type scale was used, with the question: ‘Please assess the improvement in overall condition since the start of the study using the scale below’ with the markers “very much improved, much improved, slightly improved, no change, slightly worse, much worse or very much worse”. At Visit 2 (Baseline) patients wrote a brief description of their condition which was used at Week 4 to aid their memory regarding their symptoms at study start. For each of above markers the number of participants were reported.|4 weeks|All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.||participants|||Number
677869|NCT01604265|Secondary|Change From Baseline in the Mean 0-10 Numerical Rating Scale Sleep Score at the End of Treatment (4 Weeks)|Each day patients were asked to record in their subject diary, whether or not they were “woken due to nerve pain last night”, using a 0-10 Numerical Rating Scale sleep score where zero equated with “did not disrupt sleep” and 10 meant “completely disrupts sleep (unable to sleep due to pain)”. A decrease in score from baseline indicates an improvement.|0 - 4 weeks|All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.||units on a scale||Standard Deviation|Mean
677870|NCT01604265|Primary|Change From Baseline in the Mean Pain 0-10 Numerical Rating Scale Score at the End of Treatment (4 Weeks)|"The average pain Numerical Rating Scale was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours where 0 = no pain and 10 = pain as bad as you can imagine. A negative value indicates an improvement in pain score from baseline."|0 - 4 weeks|All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.||units on a scale||Standard Deviation|Mean
677871|NCT01604122|Primary|Caregiver Burden Items Assessment: Total Cost|Caregivers completed a series of questions related to the total cost spent on providing healthcare support to participants diagnosed with ATTR.|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey. Here, ‘N’ signifies those participants who were evaluable for this measure.||dollars||Standard Deviation|Mean
677872|NCT01604122|Primary|Caregiver Burden Items Assessment: Work Time Lost|Caregivers completed a series of questions related to the loss in their working time while providing care and support to the participants diagnosed with ATTR.|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey. Here, ‘N’ signifies those participants who were evaluable for this measure.||hours||Full Range|Median
681437|NCT01556906|Primary|LDL-C|Percent change in LDL-C compared to Baseline.|Up to 16 weeks of treatment comapred to Baseline|All patients treated||percentage change in LDL-C||Standard Deviation|Mean
677873|NCT01604122|Primary|Caregiver Burden Items Assessment: Number of Hours Per Week Spent in Care of the Participants With ATTR|Caregivers completed a series of questions related to the number of hours per week spent on providing care and support to the participants diagnosed with ATTR.|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey. Here, ‘N’ signifies those participants who were evaluable for this measure.||hours per week||Full Range|Median
677874|NCT01604122|Primary|Zarit Burden Interview: Subscale Scores|A questionnaire designed to evaluate aspects of caregiver burden in terms of personal and role strain associated with caregiving. Total score of ZBI scale ranges from 0-88 with higher scores indicating increased burden of care. Five subscale scores were also calculated: (1) Burden in the relationship (consist of 6-items, ranging from 0 to 24 where higher scores indicating increased burden in relationship); (2) Emotional well-being (consisting of 7-items, ranging from 0 to 28 where higher scores indicating worse condition; (3) Social and family life (consisting of 4-items, ranging from 0 to 16 where higher scores indicating worse life condition); (4) Finances (consisting of a single item, scored from 0 to 4 where higher scores indicating worse financial condition); and (5) Loss of control over one's life (consisting of 4-items, ranging from 0 to 16 where higher scores indicating worse control over life).|Baseline (Day 1)|All participants who were included in the study and completed the survey. Here, 'n' signifies those participants who were evaluable for specific category.||units on a scale||Standard Deviation|Mean
677875|NCT01604122|Primary|Zarit Burden Interview (ZBI): Total Scores|"ZBI was a 22-item questionnaire designed to evaluate five broad aspects of caregiver burden in terms of personal and role strain associated with caregiving. Five broad aspects were: burden in the relationship, emotional well-being, social and family life, finances, loss of control over one's life. Each item rated on a 5 point scale anchored at 0 for never and 4 for nearly always. Total score ranges from 0-88 with higher scores indicating increased burden of care."|Baseline (Day 1)|All participants who were included in the study and completed the survey.||units on a scale||Standard Deviation|Mean
677876|NCT01604122|Primary|Kansas City Cardiomyopathy Questionnaire (KCCQ) Scores|KCCQ was a 23-item participant-completed questionnaire that assessed health status and health-related quality of life (HRQoL) in participants with heart failure. It was quantified in to following 10 summary scores: physical limitation, symptom frequency, symptom severity, and symptom stability, total symptoms, quality of life, social interference, self-efficacy, overall summary and clinical summary. Each summary score was scaled to range from 0 (minimum) to 100 (maximum), with higher scores representing greater disability. Total score ranged from 0 to 100, where higher scores indicated better functioning, fewer symptoms, and better disease specific quality of life.|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey. Here, ‘N’ signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
677877|NCT01604122|Primary|Norfolk Quality of Life-Diabetic Neuropathy Total Quality of Life: Subscale Scores|Norfolk QOL-DN: 35-item participant-rated questionnaire used to assess impact of neuropathy on the quality of life of participants diagnosed with ATTR. It was summarized in 5 domains: (1) Activities of daily living (score ranges from 0 to 20, where higher score=worse quality of life); (2) Large fiber neuropathy/physical functioning (score ranges from -2 to 58, where higher score=worse condition); (3) Small fiber neuropathy (score ranges from 0 to 16, where higher score=worse condition); (4) Autonomic neuropathy (score ranges from 0 to 12, where higher score=worse condition) and (5) Symptoms (score ranges from 0 to 32, where higher score=less symptoms of disease). Total possible score range= -2 to 138, where higher score=worse quality of life. This outcome measure was analyzed only for the participants diagnosed with ATTR.|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey. Here, ‘N’ signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for specific category.||units on a scale||Standard Deviation|Mean
677878|NCT01604122|Primary|Norfolk Quality of Life-Diabetic Neuropathy (Norfolk QOL-DN) Total Quality of Life (TQOL): Total Scores|Norfolk QOL-DN: 35-item participant-rated questionnaire used to assess impact of neuropathy on the quality of life of participants diagnosed with ATTR. Scoring was based on 35 questions that yield a TQOL as well as 5 subscale scores: activities of daily living, large fiber neuropathy/physical functioning, small fiber neuropathy, autonomic neuropathy, and symptoms. TQOL= sum of all the items, total possible score range= -2 to 138, where higher score=worse quality of life. This outcome measure was planned to be analyzed only for the reporting arm of participants diagnosed with ATTR.|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey. Here, ‘N’ signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
677879|NCT01604122|Primary|Participants Pain Score|Participants diagnosed with ATTR rated their pain due to the health condition based on 3 items: pain right now, average pain in the past week, and worst pain in the past week prior to baseline visit. All 3 items were rated on an 11-point numeric rating scale ranging from 0=none to 10=severe pain, where higher scores indicated severe pain.|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey. Here, ‘N’ signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
677880|NCT01604122|Primary|Healthcare Resource Use Survey: Out-of-Pocket Costs|Healthcare resources use survey of participants diagnosed with ATTR was assessed by questions concerning a variety of treatments and resources included outpatient visits to healthcare providers, hospitalizations, emergency/urgent care visits, symptomatic treatments, and out-of-pocket costs (expenditure on nutritional supplements, non-prescription medications and travel to receive medical care).|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey. Here, 'n' signifies those participants who were evaluable for specific category.||dollars||Full Range|Median
677881|NCT01604122|Primary|Healthcare Resource Use Survey: Number of Symptomatic Treatment Visits|Healthcare resources use survey of participants diagnosed with ATTR was assessed by questions concerning a variety of treatments and resources included outpatient visits to healthcare providers, hospitalizations, emergency/urgent care visits, symptomatic treatments, and out-of-pocket costs. Number of visits of participants (diagnosed with ATTR) who visited non-medical practitioners (nutrition consultant/dietician, chiropractor, acupuncturist, massage therapist, occupational therapist or other than these) for symptomatic treatments were reported.|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey. Here, ‘N’ signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for specific category.||symptomatic treatment visits||Standard Deviation|Mean
677882|NCT01604122|Primary|Healthcare and Resource Use Survey: Symptomatic Treatment of Participants|Healthcare resources use survey of participants diagnosed with ATTR was assessed by questions concerning a variety of treatments and resources included outpatient visits to healthcare providers, hospitalizations, emergency/urgent care visits, symptomatic treatments, and out-of-pocket costs. Number of participants (diagnosed with ATTR) who visited non-medical practitioners (nutrition consultant/dietician, chiropractor, acupuncturist, massage therapist, occupational therapist or other than these) for symptomatic treatments were reported.|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey.||participants|||Number
677883|NCT01604122|Primary|Healthcare Resource Use Survey: Number of Emergency Care Visits|Healthcare resources use survey of participants diagnosed with ATTR and caregivers was assessed by questions concerning a variety of different types of treatment and resources including outpatient visits to healthcare providers, hospitalizations, emergency/urgent care visits, symptomatic treatments, and out-of-pocket costs (for example, costs of travel to receive care).|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey. Here, ‘N’ signifies those participants who were evaluable for this measure.||emergency care visits||Standard Deviation|Mean
677884|NCT01604122|Primary|Healthcare Resource Use Survey: Number of Hospitalizations|Healthcare resources use survey of participants diagnosed with ATTR and caregivers was assessed by questions concerning a variety of different types of treatment and resources including outpatient visits to healthcare providers, hospitalizations, emergency/urgent care visits, symptomatic treatments, and out-of-pocket costs (for example, costs of travel to receive care).|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey. Here, ‘N’ signifies those participants who were evaluable for this measure.||hospitalization visits||Standard Deviation|Mean
677885|NCT01604122|Primary|Healthcare Resource Use Survey: Number of Outpatient Visits to Healthcare Providers|Healthcare resources use survey of participants diagnosed with ATTR and caregivers was assessed by questions concerning a variety of different types of treatment and resources including outpatient visits to healthcare providers, hospitalizations, emergency/urgent care visits, symptomatic treatments, and out-of-pocket costs (for example, costs of travel to receive care).|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey. Here, 'n' signifies those participants who were evaluable for specific category for each arm respectively.||outpatient visits||Standard Deviation|Mean
677886|NCT01604122|Primary|Work Productivity and Activity Impairment- Specific Health Version: Percent Activity Impairment|The WPAI assesses work productivity and impairment. It was a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days prior to baseline visit. The questionnaire asks about current employment status, hours worked, hours missed from work and degree to which a specified health problem (ATTR) or caregiving affected work productivity and regular activities. Component scores included percent work time missed due to the health problem; percent impairment while working due to problem; percent overall work impairment due to problem; and percent activity impairment due to problem. The computed percentage range for each sub-scale was from 0-100, where higher numbers indicating greater impairment and less productivity.|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey. Here, ‘N’ signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
677887|NCT01604122|Primary|Work Productivity and Activity Impairment- Specific Health Version: Percent Overall Work Impairment|The WPAI assesses work productivity and impairment. It was a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days prior to baseline visit. The questionnaire asked about current employment status, hours worked, hours missed from work and degree to which a specified health problem (ATTR) or caregiving affected work productivity and regular activities. Component scores included percent work time missed due to the health problem; percent impairment while working due to problem; percent overall work impairment due to problem; and percent activity impairment due to problem. The computed percentage range for each sub-scale was from 0-100, where higher numbers indicating greater impairment and less productivity.|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey. Here, ‘N’ signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
677888|NCT01604122|Primary|Work Productivity and Activity Impairment- Specific Health Version: Percent Impairment While Working|The WPAI assesses work productivity and impairment. It was a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days prior to baseline visit. The questionnaire asks about current employment status, hours worked, hours missed from work and degree to which a specified health problem (ATTR) or caregiving affected work productivity and regular activities. Component scores included percent work time missed due to the health problem; percent impairment while working due to problem; percent overall work impairment due to problem; and percent activity impairment due to problem. The computed percentage range for each sub-scale was from 0-100, where higher numbers indicating greater impairment and less productivity.|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey. Here, ‘N’ signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
677889|NCT01604122|Primary|Work Productivity and Activity Impairment- Specific Health Version (WPAI-SH): Percent of Work Time Missed|The WPAI assesses work productivity and impairment. It was a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days prior to baseline visit. The questionnaire asked about current employment status, hours worked, hours missed from work and degree to which a specified health problem (ATTR) or caregiving affected work productivity and regular activities. Percentage of work time missed of participants were recorded and reported.|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey. Here, ‘N’ signifies those participants who were evaluable for this measure.||percentage of work time missed||Full Range|Median
677890|NCT01604122|Primary|Euro Quality of Life (EQ-5D-3L)- Visual Analog Scale (VAS) Score|EQ-5D: participant rated questionnaire to assess generic health status in two parts: single utility score and visual analog scale. The VAS component rated the current health state on a scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicating a better health state.|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey. Here, ‘N’ signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
677891|NCT01604122|Primary|Euro Quality of Life (EQ-5D-3L)- Health State Profile Utility Score|EQ-5D-3L: participant rated questionnaire to assess generic health status in two parts: single utility score and visual analog scale. For utility score, participants rated their current health state on 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression with each dimension having three levels of function: 1 indicates no problem; 2 indicates some problem; 3 indicates extreme problem. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score was transformed and results in a total score range of 0.05 to 1.00; higher scores indicating a better health state.|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey. Here, ‘N’ signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
677892|NCT01604122|Primary|Hospital Anxiety and Depression Scale (HADS): Depression and Anxiety Subscale Scores|HADS: participant rated 14-item questionnaire with 2 subscales; HADS-anxiety scale (HADS-A) and HADS-depression scale (HADS-D). HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items and the participant responds as to how each item applies to him/her over the past week prior to baseline visit, on 4-point response scale. Separate scores were calculated for anxiety and depression with score ranges from 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range was from 0 to 21 for each subscale; higher score indicating greater severity of anxiety and depression symptoms.|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
677893|NCT01604122|Primary|12-Item Short-Form Health Survey (SF-12) Scores|SF-12 was a patient reported outcome survey that represented overall health status by measuring 8 health-related aspects of an individual: Body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. The score range for each of the 8 health aspects was from 0 (poor health) to 100 (better health), higher scores indicating good health condition. Responses on the SF-12 were also used to calculate 2 summary scores: Physical component score (PCS) and mental component score (MCS). The score range for each of these 2 summary scores was from 0 (poor health) to 100 (better health), where 100 indicated good health condition.|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey. Here, 'n' signifies those participants who were evaluable for specific component for each arm respectively.||units on a scale||Standard Deviation|Mean
677894|NCT01604122|Primary|Disease Characteristics of Participants: Mobility Status|Mobility, i.e., ability to walk was assessed as a part of loss of functioning in the participants diagnosed with ATTR. In this outcome, number of participants with their different mobility status along with the use of mobility aids (able to walk normally, some problems with feet but able to walk without difficulty, some difficulty walking but can walk without help, confined to bed all the time, need 1 cane or crutch to walk, need 2 canes/crutches or a walker to walk) were reported.|Baseline (Day 1)|All participants who were included in the study and completed the survey.||participants|||Number
677895|NCT01604122|Primary|Disease Characteristics of Participants: Number of Participants With Family History of ATTR|Family history of participants diagnosed with ATTR was assessed to determine whether family history of ATTR was a significant risk factor for ATTR or not. This outcome was planned to be assessed for reporting arm of participants diagnosed with ATTR.|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey.||participants|||Number
677896|NCT01604122|Primary|Disease Characteristics of Participants: Liver Transplantation Status|TTR protein is primarily synthesized in the liver. Liver transplantation was considered as one of the measure to eliminate the main source of variant TTR. In the study, participants who were diagnosed with ATTR were asked for their liver transplantation status (whether they had transplantation or not). In this outcome measure, number of participants with liver transplant status were reported. This outcome was planned to be assessed for reporting arm of participants diagnosed with ATTR.|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey.||participants|||Number
677897|NCT01604122|Primary|Disease Characteristics of Participants: Mutation Type|Genetic mutation leads to misfolding of protein transthyretin (TTR) which results in ATTR. In this outcome, number of participants with each type of resulted mutation type (Val30Met, wild type TTR, Phe64Leu, Ser77Tyr, Thr60Ala or other than these) were reported. This outcome was planned to be assessed for reporting arm of participants diagnosed with ATTR.|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey.||participants|||Number
677898|NCT01604122|Primary|Disease Characteristics of Participants: Disease Duration|Duration of disease was defined as the time from diagnosis of disease until baseline visit. This outcome measure was planned to be assessed for reporting arm of participants diagnosed with ATTR.|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey.||years||Full Range|Median
677899|NCT01604122|Primary|Demographical Characteristics of Participants|Main characteristics included were education level and employment status which were asked from all participants and caregivers. Type of job (full-time, part-time) was asked only from those participants and caregivers who provided their employment status as employed. Those who were unemployed reported their cause of unemployment, whether it was due to ATTR or not.|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey. Here, 'n' signifies those participants who were evaluable for specific category for each arm respectively.||participants|||Number
677900|NCT01604109|Secondary|Quantitative Light-induced Fluorescence (QLF) Parameters|percent fluorescence loss, lesion area, lesion volume|one calender year||||||
677901|NCT01604109|Primary|the Mean Number of Enamel Carious Lesion|tooth surface that was classified as ICDAS code 1-3|one calender year|||Surfaces||Standard Deviation|Mean
677902|NCT01603940|Secondary|Vascular Stiffness by Augmentation Index|Estimate vascular stiffness by measuring augmentation index and compare it between losartan and benazepril groups.|12 weeks|||percentage of augmentation pressure||Inter-Quartile Range|Median
677903|NCT01603940|Secondary|Diastolic Blood Pressure|Compare both group effects on diastolic blood pressure.|12 weeks|||mmHg||Inter-Quartile Range|Median
677904|NCT01603940|Secondary|Systolic Blood Pressure|Compare both groups effects on systolic blood pressure.|12 weeks|||mmHg||Inter-Quartile Range|Median
677908|NCT01603875|Primary|Rabies Neutralizing Antibodies Determine by Rapid Fluorescent Focus Inhibition Test (RFFIT)|Blood samples will be drawn on day 374(After the first injection). The samples will be centrifuged and kept as serum under - 20 degree Celsius. The serum will be test by Rapid Florescent Focus Inhibition Test. Rabies neutralizing antibody levels will be determined and expressed in international units per mL. Percentage of Subjects achieving seroconversion (defined as RNab ≥ 0.5 IU/ mL) are determine at each sampling time.|on day 374|||International unit per ml||Full Range|Geometric Mean
677909|NCT01603875|Primary|Rabies Neutralizing Antibodies Determine by Rapid Fluorescent Focus Inhibition Test (RFFIT)|Blood samples will be drawn on day 360(After the first injection). The samples will be centrifuged and kept as serum under - 20 degree Celsius. The serum will be test by Rapid Florescent Focus Inhibition Test. Rabies neutralizing antibody levels will be determined and expressed in international units per mL. Percentage of Subjects achieving seroconversion (defined as RNab ≥ 0.5 IU/ mL) are determine at each sampling time.|on day 360|||International unit per ml||Full Range|Geometric Mean
677910|NCT01603875|Primary|Rabies Neutralizing Antibodies Determine by Rapid Fluorescent Focus Inhibition Test (RFFIT)|Blood samples will be drawn on day 42(After the first injection). The samples will be centrifuged and kept as serum under - 20 degree Celsius. The serum will be test by Rapid Florescent Focus Inhibition Test. Rabies neutralizing antibody levels will be determined and expressed in international units per mL. Percentage of Subjects achieving seroconversion (defined as RNab ≥ 0.5 IU/ mL) are determine at each sampling time.|on day 42|||International unit per ml||Full Range|Geometric Mean
677911|NCT01603875|Primary|Rabies Neutralizing Antibodies Determine by Rapid Fluorescent Focus Inhibition Test (RFFIT)|Blood samples will be drawn on day 28(After the first injection). The samples will be centrifuged and kept as serum under - 20 degree Celsius. The serum will be test by Rapid Florescent Focus Inhibition Test. Rabies neutralizing antibody levels will be determined and expressed in international units per mL. Percentage of Subjects achieving seroconversion (defined as RNab ≥ 0.5 IU/ mL) are determine at each sampling time.|on day 28|||International unit per ml||Full Range|Geometric Mean
677912|NCT01603875|Primary|Rabies Neutralizing Antibodies Determine by Rapid Fluorescent Focus Inhibition Test (RFFIT)|Blood samples will be drawn on day 0(After the first injection). The samples will be centrifuged and kept as serum under - 20 degree Celsius. The serum will be test by Rapid Florescent Focus Inhibition Test. Rabies neutralizing antibody levels will be determined and expressed in international units per mL. Percentage of Subjects achieving seroconversion (defined as RNab ≥ 0.5 IU/ mL) are determine at each sampling time.|on day 0|||International unit per ml||Full Range|Geometric Mean
677913|NCT01603459|Secondary|Change in Visual Analogue Scale of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit|The EQ-5D is a common quality of life questionnaire to be filled out by the subject. It evaluates the general impact of a subject’s health in 5 dimensions, i.e., on the ability to perform daily physical activities as well as on pain perception and mood. Each dimension is scored on 1 out of 3 categories specific to each dimension, generally meaning: 1= no problem; 2 = moderate problems; 3 = severe problems). In addition, the subject was to indicate on a visual analogue scale, ranging from 0 to 100, how good or bad their own health was on the examination day (higher values indicate better outcome). This table: Positive values indicate improvement.|From Study Baseline to Week 12-16, 24-32 and 36-48|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.||units on a scale||Standard Deviation|Mean
677914|NCT01603459|Secondary|Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit|The EQ-5D is a common quality of life questionnaire to be filled out by the subject. It evaluates the general impact of a subject’s health in 5 dimensions, i.e., on the ability to perform daily physical activities as well as on pain perception and mood. Each dimension is scored on 1 out of 3 categories specific to each dimension, generally meaning: 1= no problem; 2 = moderate problems; 3 = severe problems). In addition, the subject was to indicate on a visual analogue scale, ranging from 0 to 100, how good or bad their own health was on the examination day (higher values indicate better outcome). This table: Frequency -2/-1= improvement by two/one categories; 0 = no change; +1/+2 worsening by one/two categories.|From Study Baseline to Week 12-16, 24-32 and 36-48|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.||subjects|||Number
677915|NCT01603459|Secondary|Change in Visual Analogue Scale of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles|The EQ-5D is a common quality of life questionnaire to be filled out by the subject. It evaluates the general impact of a subject’s health in 5 dimensions, i.e., on the ability to perform daily physical activities as well as on pain perception and mood. Each dimension is scored on 1 out of 3 categories specific to each dimension, generally meaning: 1= no problem; 2 = moderate problems; 3 = severe problems). In addition, the subject was to indicate on a visual analogue scale, ranging from 0 to 100, how good or bad their own health was on the examination day (higher values indicate better outcome). This table: Positive values indicate improvement|From Study Baseline to Week 4, 16-20 and 28-36|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.||units on a scale||Standard Deviation|Mean
677916|NCT01603459|Secondary|Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles|The EQ-5D is a common quality of life questionnaire to be filled out by the subject. It evaluates the general impact of a subject’s health in 5 dimensions, i.e., on the ability to perform daily physical activities as well as on pain perception and mood. Each dimension is scored on 1 out of 3 categories specific to each dimension, generally meaning: 1= no problem; 2 = moderate problems; 3 = severe problems). In addition, the subject was to indicate on a visual analogue scale, ranging from 0 to 100, how good or bad their own health was on the examination day (higher values indicate better outcome). This table: Frequency -2/-1= improvement by two/one categories; 0 = no change; +1/+2 worsening by one/two categories.|From Study Baseline to Week 4, 16-20 and 28-36|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.||subjects|||Number
677951|NCT01603420|Secondary|Assessment of Number of GI and GU Adverse Events|"Descriptive measurements of frequency will be compiled.
This study was terminated prior to the time frame of 3 years being reached. Therefore, this outcome was not assessed. Data were collected on toxicities up until study closure at 22 months. However, this timepoint was not indicated as a secondary objective in the protocol. Therefore, data was not analyzed at time of study closure."|at 3 years||||||
677917|NCT01603459|Secondary|Change in Visual Analogue Scale of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits|The EQ-5D is a common quality of life questionnaire to be filled out by the subject. In addition, the subject was to indicate on a visual analogue scale, ranging from 0 to 100, how good or bad their own health was on the examination day (higher values represent better outcome).|From Cycle Baseline to Week 4 of Each Cycle|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.||units on a scale||Standard Deviation|Mean
677918|NCT01603459|Secondary|Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits|The EQ-5D is a common quality of life questionnaire to be filled out by the subject. It evaluates the general impact of a subject’s health in 5 dimensions, i.e., on the ability to perform daily physical activities as well as on pain perception and mood. Each dimension is scored on 1 out of 3 categories specific to each dimension, generally meaning: 1= no problem; 2 = moderate problems; 3 = severe problems). In addition, the subject was to indicate on a visual analogue scale, ranging from 0 to 100, how good or bad their own health was on the examination day (higher values indicate better outcome). This table: Frequency -2/-1= improvement by two/one categories; 0 = no change; +1/+2 worsening by one/two categories.|From Cycle Baseline to Week 4 of Each Cycle|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.||Subjects|||Number
677919|NCT01603459|Secondary|Visual Analogue Scale (VAS) of EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores|The EQ-5D is a common quality of life questionnaire to be filled out by the subject. In addition, the subject was to indicate on a visual analogue scale, ranging from 0 to 100, how good or bad their own health was on the examination day (higher values represent better outcome).|From Cycle Baseline to Week 4 of Each Cycle|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.||units on a scale||Standard Deviation|Mean
677920|NCT01603459|Secondary|EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores|The EQ-5D is a common quality of life questionnaire to be filled out by the subject. It evaluates the general impact of a subject’s health in 5 dimensions, i.e., on the ability to perform daily physical activities as well as on pain perception and mood. Each dimension is scored on 1 out of 3 categories specific to each dimension, generally meaning: 1= no problem; 2 = moderate problems; 3 = severe problems.|From Cycle Baseline to Week 4 of Each Cycle|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.||subjects|||Number
677921|NCT01603459|Secondary|Global Assessment of Efficacy Scores|Investigator assessment. The global assessment of efficacy will be assessed by the investigator, the subject, and the caregiver using a 4-point Likert scale with the ratings 1 = very good, 2 = good, 3 = moderate, and 4 = poor.|Week 12-16, 24-32 and 36-48|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.||subjects|||Number
677922|NCT01603459|Secondary|Change of Disability Assessment Scale (DAS) Score in a Selected Principal Therapeutic Target Domain Affecting the Upper Limb From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit.|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which are assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). One of the domains will be selected per subject per injection cycle. Arithmetic means are built on each patient's target domain value change.|From Study Baseline to Week 12-16, 24-32 and 36-48|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.||units on a scale||Standard Deviation|Mean
677923|NCT01603459|Primary|Investigator’s Global Assessment of Tolerability in Subjects|A 4-point Likert scale was used with the ratings 1 = very good, 2 = good, 3 = moderate, and 4 = poor.|Up to Week 48|Safety evaluation set (SES) - only subjects treated in the respective injection cycle were analyzed.||subjects|||Number
677924|NCT01603459|Primary|Occurrence of Treatment-Emergent Adverse Events (AEs), AEs of Special Interest (AESIs), and Serious AEs (SAEs) by Injection Cycle, Overall and Related to the Administration of Study Medication|Treatment-emergent Adverse Events (TEASs) are events observed from the time point of first injection until 16 weeks after last injection. Values reported here refer to the number of subjects affected.|From baseline to week 36-48|Safety evaluation set (SES) - only subjects treated in the respective injection cycle were analyzed.||subjects|||Number
677925|NCT01603459|Secondary|Change of Disability Assessment Scale (DAS) Score in a Selected Principal Therapeutic Target Domain Affecting the Upper Limb From Study Baseline Visit to Control Visits of Injection Cycles|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which are assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). One of the domains will be selected per subject per injection cycle. Arithmetic means are built on each patient's target domain value change.|From Study Baseline to Week 4, 16-20 and 28-36|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.||units on a scale||Standard Deviation|Mean
677926|NCT01603459|Secondary|Change of Disability Assessment Scale (DAS) Score in a Selected Principal Therapeutic Target Domain Affecting the Upper Limb From Injection Cycle Baseline Visits to Respective Control Visits|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which are assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). One of the domains will be selected per subject per injection cycle. Arithmetic means are built on each patient's target domain value change.|Week 4 of Each Cycle|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.||units on a scale||Standard Deviation|Mean
677927|NCT01603459|Secondary|Disability Assessment Scale (DAS) Scores in a Selected Principal Therapeutic Target Domain Affecting the Upper Limb|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which are assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). One of the domains will be selected per subject per injection cycle. Arithmetic means are built on each patient's target domain value.|From Cycle Baseline to Week 4 of Each Cycle|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.||units on a scale||Standard Deviation|Mean
677952|NCT01603420|Secondary|Assessment of Number of Grade 2 or Higher Genitourinary (GU) and Gastrointestinal (GI) Adverse Events|Assessment will be performed using CTCAE v 4 criteria.|at 6 months|||incidences|||Number
677928|NCT01603459|Secondary|Goal Attainment Scale (GAS) Scores for Upper and Lower Limb, Respectively|Change in goal attainment T-scores from respective injection cycle baseline visit. GAS measures the extent to which subject's individual goals are achieved in course of intervention. Subject and treating team have to identify 2 personal goals for each treated limb at each injection cycle. Investigator rates the GAS score for each injection cycle. Degree of goal attainment is rated on 5-point scale (-2, -1, 0, +1, +2; study baseline set to -1) and in order to account for interindividual differences in the number of goals, ratings are computed with the Kiresuk formula (Kiresuk & Sherman, Community Mental Health Journal. 1968;4(6):443-53) resulting in T-scores measuring the degree of goal attainment at each visit. A score of 50 indicates that the individual has reached the expected level of achievement for all goals. The size of change from measurement to measurement indicates incremental change towards or away from goal attainment. Positive values indicate a higher goal attainment.|From Cycle Baseline Visit to Week 12-16, 24-32 and 36-48|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.||units on a scale||Standard Deviation|Mean
677929|NCT01603459|Secondary|Change of Functional Ambulation Classification (FAC) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit|The FAC examines the independence and ambulation of subjects whereby supervision/physical assistance from 1 person is allowed. Subjects are classified to following categories: Level 0: no functional ambulation; Level 1: Ambulator-dependent for physical assistance (Level II); Level 2: Ambulator-dependent for physical assistance (Level I); Level 3: Ambulator-dependent for supervision; Level 4: Ambulator-independent, level surface only; Level 5: Ambulator-independent.|From Study Baseline to Week 12-16, 24-32 and 36-48|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.||units on a scale||Standard Deviation|Mean
677930|NCT01603459|Secondary|Change of Functional Ambulation Classification (FAC) Score From Study Baseline Visit to Control Visits of Injection Cycles|The FAC examines the independence and ambulation of subjects whereby supervision/physical assistance from 1 person is allowed. Subjects are classified to following categories: Level 0: no functional ambulation; Level 1: Ambulator-dependent for physical assistance (Level II); Level 2: Ambulator-dependent for physical assistance (Level I); Level 3: Ambulator-dependent for supervision; Level 4: Ambulator-independent, level surface only; Level 5: Ambulator-independent.|From Study Baseline to Week 4, 16-20 and 28-36|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.||units on a scale||Standard Deviation|Mean
677931|NCT01603459|Secondary|Change of Functional Ambulation Classification (FAC) Score From Injection Cycle Baseline Visits to Respective Control Visits|The FAC examines the independence and ambulation of subjects whereby supervision/physical assistance from 1 person is allowed. Subjects are classified to following categories: Level 0: no functional ambulation; Level 1: Ambulator-dependent for physical assistance (Level II); Level 2: Ambulator-dependent for physical assistance (Level I); Level 3: Ambulator-dependent for supervision; Level 4: Ambulator-independent, level surface only; Level 5: Ambulator-independent.|From Cycle Baseline to Week 4 of Each Cycle|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.||units on a scale||Standard Deviation|Mean
677932|NCT01603459|Secondary|Functional Ambulation Classification (FAC) Scale Scores|The FAC examines the independence and ambulation of subjects whereby supervision/physical assistance from 1 person is allowed. Subjects are classified to following categories: Level 0: no functional ambulation; Level 1: Ambulator-dependent for physical assistance (Level II); Level 2: Ambulator-dependent for physical assistance (Level I); Level 3: Ambulator-dependent for supervision; Level 4: Ambulator-independent, level surface only; Level 5: Ambulator-independent.|From Cycle Baseline to Week 4 of Each Cycle|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.||units on a scale||Standard Deviation|Mean
677933|NCT01603459|Secondary|Change of Resistance to Passive Movement Scale (REPAS) Score of Treated Side From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit|The REPAS is a summary 26-item test used to assess resistance to passive movement in all four limbs of the body. It provides a global evaluation of spasticity status, as well as per hemibody and per limb. 16 items describe the condition of both upper limbs, 10 that of both lower limbs. Each item is rated by using the Ashworth Scale. The sum of the values represent the REPAS score which may range from zero (no resistance for any item) to 104 (limbs rigid for all items). Here, the hemi-REPAS was evaluated, i.e. the maximum value for the treated body side was 52.|From Study Baseline to Week 12-16, 24-32 and 36-48|The full analysis set is the subset of all subjects who were exposed to study medication at least once.||units on a scale||Standard Deviation|Mean
677934|NCT01603459|Secondary|Change of Resistance to Passive Movement Scale (REPAS) Score of Treated Side From Study Baseline Visit to Control Visits of Injection Cycles|The REPAS is a summary 26-item test used to assess resistance to passive movement in all four limbs of the body. It provides a global evaluation of spasticity status, as well as per hemibody and per limb. 16 items describe the condition of both upper limbs, 10 that of both lower limbs. Each item is rated by using the Ashworth Scale. The sum of the values represent the REPAS score which may range from zero (no resistance for any item) to 104 (limbs rigid for all items). Here, the hemi-REPAS was evaluated, i.e. the maximum value for the treated body side was 52.|From Study Baseline to Week 4, 16-20 and 28-36|The full analysis set is the subset of all subjects who were exposed to study medication at least once.||units on a scale||Standard Deviation|Mean
677935|NCT01603459|Secondary|Change of Resistance to Passive Movement Scale (REPAS) Score of Treated Side From Injection Cycle Baseline Visits to Respective Control Visits|The REPAS is a summary 26-item test used to assess resistance to passive movement in all four limbs of the body. It provides a global evaluation of spasticity status, as well as per hemibody and per limb. 16 items describe the condition of both upper limbs, 10 that of both lower limbs. Each item is rated by using the Ashworth Scale. The sum of the values represent the REPAS score which may range from zero (no resistance for any item) to 104 (limbs rigid for all items). Here, the hemi-REPAS was evaluated, i.e. the maximum value for the treated body side was 52.|From Cycle Baseline to Week 4 of Each Cycle|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.||units on a scale||Standard Deviation|Mean
677997|NCT01602744|Primary|SF-12 Health Survey questionnaire-the Physical Component Summary (PCS)|Quality of life was assessed by the SF-12 Health Survey questionnare. Results are expressed in terms of two meta scores:the Physical Component Summary (PCS) AND Mental Component Summary (MCS). The PCS and MCS scores have a range of 0 to 100, thus scores greater than 50 represent a better than average health status.|Outcome measures were assessed at the end of the 12 month follow up|||units on a scale||Standard Deviation|Mean
677936|NCT01603459|Secondary|Resistance to Passive Movement Scale (REPAS) Scores of Treated Side|The REPAS is a summary 26-item test used to assess resistance to passive movement in all four limbs of the body. It provides a global evaluation of spasticity status, as well as per hemibody and per limb. 16 items describe the condition of both upper limbs, 10 that of both lower limbs. Each item is rated by using the Ashworth Scale. The sum of the values represent the REPAS score which may range from zero (no resistance for any item) to 104 (limbs rigid for all items). Here, the hemi-REPAS was evaluated, i.e. the maximum value for the treated body side was 52.|From Cycle Baseline to Week 4 of Each Cycle|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.||units on a scale||Standard Deviation|Mean
677937|NCT01603459|Secondary|Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit|Clinical pattern treated at corresponding cycle of the same body side as the selected target joint. The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|From Study Baseline to Week 12-16, 24-32 and 36-48|Full analysis set (FAS) - only subjects treated in the respective pattern of respective injection cycle were analyzed.||units on a scale||Standard Deviation|Mean
677938|NCT01603459|Secondary|Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Control Visits of Injection Cycles|Clinical pattern treated at corresponding cycle of the same body side as the selected target joint. The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|From Study Baseline to Week 4, 16-20 and 28-36|Full analysis set (FAS) - only subjects treated in the respective pattern of respective injection cycle were analyzed.||units on a scale||Standard Deviation|Mean
677939|NCT01603459|Secondary|Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Injection Cycle Baseline Visits to Respective Control Visits|Clinical pattern treated at corresponding cycle of the same body side as the selected target joint. The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|From Cycle Baseline to Week 4 of Each Cycle|Full analysis set (FAS) - only subjects treated in the respective pattern of respective injection cycle were analyzed.||units on a scale||Standard Deviation|Mean
677940|NCT01603459|Secondary|Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity|Clinical pattern treated at corresponding cycle of the same body side as the selected target joint. The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|From Cycle Baseline to Week 4 of Each Cycle|Full analysis set (FAS) - only subjects treated in the respective pattern in the respective injection cycle.||units on a scale||Standard Deviation|Mean
677941|NCT01603459|Secondary|Change of Ashworth Scale (AS) Score of the Target Joint Selected at Study Baseline Visit From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit|The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|From Study Baseline to Week 12-16, 24-32 and 36-48|Full analysis set (FAS), observed cases, only subjects treated in the target joint in the respective cycle were analyzed.||units on a scale||Standard Deviation|Mean
677942|NCT01603459|Secondary|Change of Ashworth Scale (AS) Score of the Target Joint Selected at Study Baseline Visit From Study Baseline Visit to Control Visits of Injection Cycles|The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|From Study Baseline to Week 4, 16-20 and 28-36|Full analysis set (FAS), observed cases, only subjects treated in the target joint in the respective cycle were analyzed.||units on a scale||Standard Deviation|Mean
677943|NCT01603459|Secondary|Change of Ashworth Scale (AS) Score of the Target Joint Selected at Study Baseline Visit From Injection Cycle Baseline Visits to Respective Control Visits|The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|From Cycle Baseline to Week 4 of Each Cycle|Full analysis set (FAS), observed cases, only subjects treated in the target joint in the respective cycle were analyzed.||units on a scale||Standard Deviation|Mean
677944|NCT01603459|Secondary|Ashworth Scale (AS) Scores of the Target Joint Selected at Study Baseline Visit|The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|From Cycle Baseline to Week 4 of Each Cycle|The full analysis set (FAS) is the subset of all subjects who were exposed to study medication at least once. Only subjects treated in the target joint in the respective cycle were analyzed.||units on a scale||Standard Deviation|Mean
677945|NCT01603420|Secondary|Assessment of Quality of Life - Summation of Relative Scores From the EPIC Instrument.|unable to assess due to lack of data|Up to 10 years|unable to assess due to study termination|||||
677946|NCT01603420|Secondary|Assessment of Total Number of Biochemical Failure Events|The number of biochemical failure events will be assessed on both arms.|at study closure (22 months)|||participants|||Number
677953|NCT01603420|Primary|Phase 3 - Assessment of the Number of Freedom From Failure (FFF) Events Comparing the Chemotherapy Arm to the Standard Treatment Arm.|"The events for FFF will be the first occurence of clinical failure (local recurrence, regional recurrence, or distant metastasis), biochemical failure by the Phoenix definition (PSA > = ng/ml over the nadir PSA discounting bounces per the investigators discretion), or the start of salvage androgen deprivation.
This study was terminated prior to a decision being made about moving on to a phase 3 study. Therefore, this outcome was not assessed."|at 5 years|This study was terminated prior to a decision being made about moving on to a phase 3 study. Therefore, this outcome was not assessed.|||||
677954|NCT01603420|Primary|Phase 2 - Cumulative Number of Incidences of Grade 3 or Higher Adverse Events.|"Assessment will be performed using CTCAE v4 criteria.
This study was terminated prior to the time frame of 2 years being reached. Therefore, this outcome was assessed at time of study closure (22 months)."|2 years|This study was terminated prior to the time frame of 2 years being reached. Therefore, this outcome was assessed at time of study closure (22 months).||events|||Number
677955|NCT01603420|Primary|Phase 2 - Assessment of Number of Freedom From Failure Event Comparing Chemotherapy Arm to Standard Treatment Arm|"This endpoint will be examined if decision is made to not move forward with phase 3 study.
This study was terminated prior to a decision being made about moving on to a phase 3 study. Therefore, this outcome was not assessed."|at 5 years||||||
677956|NCT01603420|Primary|Phase 2 - Assessment of Number of Freedom From Failure Events in the Chemotherapy Arm|"Measurement of Freedom from Failure i.e. the first occurence of clinical failure (local recurrence, regional recurrence, or distant metastasis), biochemical failure by the Phoenix definition (Prostate Specific Antigen [PSA] > = 2 ng/ml over the nadir PSA discounting bounces per the investigators discretion), or the start of salvage therapy including androgen deprivation.
This study was terminated prior to the time frame of 2 years being reached. Therefore, this outcome was assessed at time of study closure (22 months)."|No failures were reported at the time of study termination (22 months). This outcome was originally written to assess failure at 2 years. However, that end point was not reached.|No failures were reported at the time of study termination (22 months). This outcome was originally written to assess failure at 2 years. However, that end point was not reached.||failure events|||Number
677957|NCT01603394|Secondary|Change From Baseline to End of the Study (Week 6) in the Daily Sleep Interference Diary (NRS) Mean Pain Score.|The pain-related sleep interference item rating scale is scored on an 11-point numeric rating scale (NRS-Sleep). It is self-administered by the participant in order to rate how pain has interfered with their sleep during the past 24 hours, ranging from 0 (pain does not interfere with sleep) to 10 (completely interferes (unable to sleep due to pain). Participants are to describe how their pain has interfered with their sleep during the past 24 hours by choosing the appropriate number on the numeric rating scale.|Baseline, Week 6|Only 9 of the 200 participants were enrolled into the trial, so we are unable to get adequate results from this study.|||||
677958|NCT01603394|Secondary|Short Form 12v2 Health Survey (SF 12v2) at Visit 2 (Week 0), and Week 6/Early Termination.|The Short-Form 12 Health Survey (SF-12v2) is a self-administered, validated questionnaire that measures each of the following 8 health aspects: Physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception over the past week. Higher scores indicate a better health-related quality of life.|Visit 2 (Week 0), and Week 6/Early Termination|Only 9 of the 200 participants were enrolled into the trial, so we are unable to get adequate results from this study.|||||
677959|NCT01603394|Secondary|Pain NRS Score; 1 Week Recall Period.|The numeric rating scale for pain (NRS-Pain) consists of an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain.|1 Week|Only 9 of the 200 participants were enrolled into the trial, so we are unable to get adequate results from this study.|||||
677960|NCT01603394|Secondary|Patient Catastrophizing Scale (PCS) at Visit 2 (Week 0) and Week 6.|The PCS is a 13-item self report instrument and requires a Grade 6 reading level and has been translated into 12 languages. It instructs participants to reflect on past experience of pain and indicate their experience using a 5-point scale. The PCS was designed for research on catastrophizing and pain experience. Catastrophizing is associated with heightened pain and is “an exaggerated negative mental set brought to bear during actual or anticipated painful experience.” It is a multidimensional construct compromising elements of rumination, magnification, and helplessness and its factor structure has been replicated. It has a total score and three subscale scores (score range of 0-52).|Visit 2 (Week 0), Week 6|Only 9 of the 200 participants were enrolled into the trial, so we are unable to get adequate results from this study.|||||
677961|NCT01603394|Secondary|Brief Pain Inventory (BPI sf) at Visit 2 (Week 0) and Week 6.|The Brief Pain Inventory-Short Form (BPI-sf) consists of 5 questions. Questions 1, 2, 3, and 4 measure pain on an 11-point scale from 0 (no pain) to 10 (worst pain possible).|Visit 2 (Week 0), Week 6|Only 9 of the 200 participants were enrolled into the trial, so we are unable to get adequate results from this study.|||||
677962|NCT01603394|Secondary|Patient Health Questionnaire-8 (PHQ-8) at Baseline and Week 6; Generalized Anxiety Disorder-7 (GAD-7) at Screening, Visit 2 (Week 0) and Week 6/Early Termination.|The PHQ-8 is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as 0 (not at all) to 3 (nearly every day). The PHQ-8 is a validated subset of the PHQ-9, which comprises the first 8 items of the measure. The GAD-7 is a 7-item questionnaire that assesses anxiety. Participants respond as to how each item applies to them on a 4 point response scale. The higher the score, the more severe the anxiety.|Screening, Visit 2 (Week 0) and Week 6/Early Termination|Only 9 of the 200 participants were enrolled into the trial, so we are unable to get adequate results from this study.|||||
677963|NCT01603394|Secondary|Proportion of Participants Within Each Phenotype Group as Determined by Sensory Symptom Clustering Using the PainPREDICT, PainDETECT and Neuropathic Pain Symptom Inventory at Baseline and Week 6.|To explore whether sensory symptom cluster analysis is useful for predicting treatment response in paticipants with PHN, identification of the phenotype was initially required of all participants using three different approaches (with or without the baseline PHQ-8, GAD-7 Pain Related Sleep Interference Score Scale, PCS): 1. PainDETECT at baseline, 2. PainPREDICT at baseline, 3. NPSI at baseline.|Baseline, Week 6|Only 9 of the 200 participants were enrolled into the trial, so we are unable to get adequate results from this study.|||||
677964|NCT01603394|Secondary|Proportions of Participants With >/=30% and >/=50% Pain Reduction Based on Daily Pain Diary at Baseline and Week 6.|The daily pain diary consists of an 11-point numeric scale ranging from 0 (“no pain”) to 10 (“worst possible pain”). Participants describe their pain during the previous 24 hours by choosing the appropriate number between 0 and 10. Self-assessment is performed daily at bedtime on a telephone via interactive voice response system (IVRS). The endpoint mean pain score is defined as the mean of the last 7 daily diary pain ratings while taking study medication in the open-label phase. Daily pain IVRS diaries were completed daily at bedtime from Visit 1 (Screening) through Visit 7/Early Termination. Participants were asked to complete their first IVRS daily at bedtime on the morning after Visit 1.|Baseline, Week 6|Only 9 of the 200 participants were enrolled into the trial, so we are unable to get adequate results from this study.|||||
677965|NCT01603394|Secondary|Patient Global Impression of Change (PGIC) at Week 6/Early Termination.|PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse).|Week 6/Early Termination|Only 9 of the 200 participants were enrolled into the trial, so we are unable to get adequate results from this study.|||||
677966|NCT01603394|Secondary|Proportion of Phenotypes Within the 30% and 50% Responder Groups at Baseline and Week 6.|To explore whether sensory symptom cluster analysis is useful for predicting treatment response in paticipants with PHN, identification of the phenotype was initially required of all participants using three different approaches (with or without the baseline PHQ-8, GAD-7 Pain Related Sleep Interference Score Scale, PCS): 1. PainDETECT at baseline, 2. PainPREDICT at baseline, 3. NPSI at baseline. Then for each of the above phenotypes the distribution of the pregabalin responders (using 30% and 50%) were to be compared.|Baseline, Week 6|Only 9 of the 200 participants were enrolled into the trial, so we are unable to get adequate results from this study.|||||
677967|NCT01603394|Secondary|Neuropathic Pain Symptom Inventory (NPSI) at All Visits.|NPSI: participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.|All visits|Only 9 of the 200 participants were enrolled into the trial, so we are unable to get adequate results from this study.|||||
677968|NCT01603394|Primary|Change From Baseline in the Daily Pain Diary (Numerical Rating Scale, NRS) Mean Pain Score at the End of the Study (Week 6).|The numeric rating scale for pain (NRS-Pain) consists of an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain.|Baseline, Week 6|Only 9 of the 200 participants were enrolled into the trial, so we are unable to get adequate results from this study.|||||
677969|NCT01603277|Secondary|To Evaluate the Safety and Tolerability of KB003 as Measured by Frequency and Severity of AEs, Clinical Safety, Laboratory Abnormalities and Chest Radiographic Assessments||Week 24||||||
677970|NCT01603277|Secondary|To Evaluate the Effect of KB003 on Peak Expiratory Flow (PEF)||Week 24||||||
677971|NCT01603277|Secondary|To Evaluate the Efficacy of KB003 as Measured by Asthma Exacerbation Rate||Week 24||||||
677972|NCT01603277|Primary|Change in Percent Predicted FEV1 at Week 24||Baseline to Week 24|||Percent||Standard Deviation|Mean
677973|NCT01603121|Secondary|Evaluation of Early Efficacy of Study Drug|Blood draws will be performed at predetermined time points during and after the infusions in order to measure serum cytokine and chemokine concentrations, as well as to measure plasma STAT 4 and phosphorylated STAT 4 (markers of lisofylline efficacy).|24 hours||||||
677974|NCT01603121|Secondary|Study Drug Bioavailability After Subcutaneous and Intravenous Infusion|Blood will be collected for determination of lisofylline concentrations at various predetermined time points during the infusions, and 10 and 24 hours following infusion completion. This will help to determine if subcutaneous infusion over 10 hours results in similar lisofylline plasma concentrations as with intravenous infusion.|24 hours||||||
677975|NCT01603121|Primary|Safety and Tolerability of Study Drug|"Subjects will be monitored for adverse events both during and after the study drug infusion and will undergo physical examinations, electrocardiograms and clinical safety laboratory tests.
Study staff will contact subjects within 5 days after each dosing period and approximately 30 days after the 2nd dosing period, to review laboratory results and to ask the subject about any changes in health that they have experienced. Should the subject require an in-person evaluation, this will be arranged with the principal or sub-investigator promptly."|1 month||||||
677976|NCT01603082|Secondary|Inhibition of the P2Y12 Receptor at 0.5 Hours, End of PCI, and 8 Hours After Loading Doses of Ticagrelor and Clopidogrel as Measured by PRU From VerifyNow™|Participants with low (<150) baseline PRU values were excluded.|0.5 hours, end of PCI, and 8 hours after the loading dose|PD Analysis Set. Participants in the PD Analysis Set with low (<150) baseline PRU values were excluded from the analyses.||PRU||Standard Deviation|Mean
677977|NCT01603082|Primary|Inhibition of the P2Y12 Receptor at 2 Hours After Loading Doses of Ticagrelor and Clopidogrel as Measured by P2Y12 Reaction Units (PRU) From VerifyNow™|Participants with low (<150) baseline PRU values were excluded.|2 hours after the loading dose|Pharmacodynamic (PD) Analysis Set (N=93; 46 on ticagrelor, 47 on clopidogrel) - included all participants with PD data and without a major protocol deviation thought to significantly affect the PD of ticagrelor or clopidogrel. Participants in the PD Analysis Set with low (<150) baseline PRU values were excluded from the analyses.||PRU||Standard Deviation|Mean
677998|NCT01602744|Secondary|Pharmacoeconomics Analysis-Costs of Medication|The costs on medications in the geriatric hospital before and after intervention e.g. pharmaeconomic analysis of the intervention. Costs of medications were calculated in New Israeli shekels per month and taken from the Ministry of Health's medication price list.|Outcome measures were assessed at the end of the 12 month follow up|||New Israeli shekels per month||Standard Deviation|Mean
677999|NCT01602744|Primary|Quality of Life- Mental Component Summaty (MCS)|Quality of life will be measured by MOS SF-12 Health Survey questionnare. Results are expressed in terms of two meta scores: The Physical Component Summary(PCS) and the Mental Component Summary (MCS). The PCS and MCS scores have a range of 0 to 100, thus scores greater than 50 represent a better than average health status.|Outcome measures were assessed at the end of the 12 month follow up|||units on a scale||Standard Deviation|Mean
677978|NCT01603056|Secondary|The Change From Baseline in Asthma Medication Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated|"Subjects were provided with open-labelled rescue medication to be used as needed for treatment of their Asthma symptoms. Subjects reported their use of specific rescue medication via the patient diary cards. Scoring principles were applied to transform the number of rescue medication doses used into medication scores. The scores of all the medication used were summed to produce the daily asthma medication score range from 0 to 32. A lower medication score means the patient use less medication, and represent a better outcome; on the contrary, a higher medication score means the patient use more medication, and represent a worse outcome.
Baseline was set as from V1 (Week -8) to V2 (Week 0). 11-12months’ end evaluation period was set from V8(Week 44) to V9(Week 52). These two average scores (Baseline and 11-12months) were calculated for each patient as the sum of the daily score throughout the 2 months in evaluation period and divided with the days with diary."|Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52).|The analysis was performed in the Full Analysis Set.||units on a scale(Medication score)||Standard Deviation|Mean
677979|NCT01603056|Secondary|The Change From Baseline in Asthma Quality of Life Questionnaire at 12 Months Between the Actively Treated Patients and the Placebo Treated.|The baseline AQLQ value was collected in Visit 1 (Week -8) and the 12 months’ RQLQ value was collected in Visit 9 (Week 52). The maximum value of RQLQ score is 217 and the minimum one is 0. The score is elevated as the life quality is better.|Visit 1 date(Week -8), Visit 9 date(Week 52).|The analysis was performed in the Full Analysis Set.||units on a scale(AQLQ score)||Standard Deviation|Mean
677980|NCT01603056|Secondary|The Change From Baseline in Rhinitis Medication Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated.|"Subjects were provided with open-labelled rescue medication to be used as needed for treatment of their Rhinitis symptoms. Subjects reported their use of specific rescue medication via the patient diary cards. Scoring principles were applied to transform the number of rescue medication doses used into medication scores. The scores of all the medication used were summed to produce the daily Rhinitis medication score range from 0 to 30. A lower medication score means the patient use less medication, and represent a better outcome; on the contrary, a higher medication score means the patient use more medication, and represent a worse outcome.
Baseline was set as from V1 (Week -8) to V2 (Week 0). 11-12months’ end evaluation period was set from V8(Week 44) to V9(Week 52). These two average scores (Baseline and 11-12months) were calculated for each patient as the sum of the daily score throughout the 2 months(8 weeks in count) in evaluation period and divided with the days with diary."|Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52).|The analysis was performed in the Full Analysis Set.||units on a scale(Medication score)||Standard Deviation|Mean
677981|NCT01603056|Secondary|Global Assessment of Rhinoconjunctivitis Symptom After Treatment Between the Actively Treated Patients and the Placebo Treated.|Comparing overall rhinoconjunctivitis symptoms at the end of study year Between the Actively Treated Patients and the Placebo Treated.|Visit 9 date, Week 52|The analysis was performed in the Full Analysis Set.||participants|||Number
677982|NCT01603056|Secondary|The Change From Baseline in Rhinitis Quality of Life Questionnaire at 12 Months Between the Actively Treated Patients and the Placebo Treated.|"The baseline RQLQ value was collected in Visit 1 (Week -8) and the 12 months' RQLQ value was collected in Visit 9 (Week 52).
The maximum value of RQLQ score is 168 and the minimum one is 0. The score is decreased as the life quality is better."|Visit 1 date(Week -8), Visit 9 date(Week 52).|The analysis was performed in the Full Analysis Set.||units on a scale (RQLQ score)||Standard Deviation|Mean
677983|NCT01603056|Secondary|The Change From Baseline in Nasal Complain Scores on Visual Analog Scale at 11-12 Months Between the Actively Treated Patients and the Placebo Treated.|"The average rhinoconjunctivitis VAS score (baseline to first year). The scale answers the question ‘How have your nasal complaints been today?’ from 0 = no symptoms to 10 = severe symptoms.
The baseline VAS rhinoconjunctivitis score is the average value of VAS scores in V1 (Screen Visit, Week -8) and V2 (Randomization visit, Week 0), and Evaluation period (Months 11-12) VAS rhinoconjunctivitis score is the average value of VAS scores in V8 (Week 44) and V9 (Week 52)."|Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52).|The analysis was performed in the Full Analysis Set.||units on a scale (VAS Score)||Standard Deviation|Mean
677984|NCT01603056|Secondary|Percentage of Healthy Days in This Study Between the Actively Treated Patients and the Placebo Treated.|A healthy day is a day without rhinoconjunctivitis symptoms and without any intake of rescue medication. Percentage of healthy days is the healthy days of subject in this study divided by the total study days.|Total study year|The analysis was performed in the Full Analysis Set.||Percentage of healthy days||Standard Deviation|Mean
677985|NCT01603056|Secondary|The Change From Baseline in Asthma Symptom Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated.|"Subjects were instructed by the investigator on how to complete symptom assessments and recorded the results in the patient diary cards on a daily basis.
A total of 4 Asthma symptoms were measured on a scale from 0-3 as follows:
0 = No symptoms.
= Mild symptoms.
= Moderate symptoms. 3= Severe symptoms. The 4 symptoms as follows: Cough, Wheeze, Chest tightness/shortness of breath (dyspnoea), Exercise induced symptoms. The 4 symptom scores were summed to obtain the asthma symptoms score with range 0(best) to 12(worst).
Baseline was set as 8 weeks before randomization as from V1 (Week -8) to V2 (Week 0). 11-12months’ end evaluation period was set from V8(Week 44) to V9(Week 52). These two average scores (Baseline and 11-12months) were calculated for each patient as the sum of the daily score throughout the 2 months(8 weeks in count) in evaluation period and divided with the days with diary."|Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52).|The analysis was performed in the Full Analysis Set.||units on a scale(Symptom score)||Standard Deviation|Mean
678000|NCT01602731|Primary|Feasibility of AMDD to Improve Medication Adherence Via Completion Rate|Rate that patient population completed set-up of AMDD was evaluated quantitatively.|4 months|Of 45 patients who started the study, 24 patients met the predetermined criteria for AMDD. Though all of the patients had agreed to set up the AMDD in their home, only 15 out of 24 ended up completing the setup in their home.||participants|||Number
678001|NCT01602731|Secondary|Efficacy of AMDD to Improve Medication Adherence|Change in medication adherence (proportion of pills taken of prescribed, as measured by pillcount) after the implementation of the AMDD|30-day pill count before the use of AMDD and with AMDD|||percentage of adherence||Full Range|Mean
677986|NCT01603056|Secondary|The Change From Baseline in Conjunctivitis Symptom Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated.|"Subjects were instructed by the investigator on how to complete symptom assessments and recorded the results in the patient diary cards on a daily basis.
A total of 2 conjunctivitis symptoms were measured on a scale from 0-3 as follows:
0 = No symptoms.
= Mild symptoms.
= Moderate symptoms. 3= Severe symptoms. The 2 symptoms as follows: Gritty feeling/red/itchy eyes, Watery eyes. The 2 symptom scores were summed to obtain the conjunctivitis symptoms score with range 0(best) to 6(worst).
Baseline was set as 8 weeks before randomization as from V1 (Week -8) to V2 (Week 0). 11-12months’ end evaluation period was set from V8(Week 44) to V9(Week 52). These two average scores (Baseline and 11-12months) were calculated for each patient as the sum of the daily score throughout the 2 months(8 weeks in count) in evaluation period and divided with the days with diary."|Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52).|The analysis was performed in the Full Analysis Set.||units on a scale(Symptom score)||Standard Deviation|Mean
677987|NCT01603056|Secondary|The Change From Baseline in Rhinitis Symptom Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated.|"Subjects were instructed by the investigator on how to complete symptom assessments and recorded the results in the patient diary cards on a daily basis.
A total of 4 rhinitis symptoms were measured on a scale from 0-3 as follows:
0 = No symptoms.
= Mild symptoms.
= Moderate symptoms. 3= Severe symptoms. The 4 symptoms are as follows: Runny nose, Blocked nose, Sneezing, Itchy nose. The 4 symptom scores were summed to obtain the rhinitis symptoms score with range 0(best) to 12(worst).
Baseline was set as 8 weeks before randomization as from V1 (Week -8) to V2 (Week 0). 11-12months’ end evaluation period was set from V8(Week 44) to V9(Week 52). These two average scores (Baseline and 11-12months) were calculated for each patient as the sum of the daily score throughout the 2 months(8 weeks in count) in evaluation period and divided with the days with diary."|Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52).|The analysis was performed in the Full Analysis Set.||units on a scale (Symptom score)||Standard Deviation|Mean
677988|NCT01603056|Primary|The Change From Baseline in Rhinoconjunctivitis Medication Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated.|"Subjects were provided with open-labelled rescue medication to be used as needed for treatment of their rhinoconjunctivitis symptoms. Subjects reported their use of specific rescue medication via the patient diary cards. Scoring principles were applied to transform the number of rescue medication doses used into medication scores.The scores of all the medication used were summed to produce the daily rhinoconjunctivitis medication score range from 0 to 32. A lower medication score means the patient use less medication, and represent a better outcome; on the contrary, a higher medication score means the patient use more medication, and represent a worse outcome.
Baseline was from V1 (Week -8) to V2 (Week 0). The end evaluation period was set from V8(Week 44) to V9(Week 52). These two average scores (Baseline and End) were calculated for each patient as the sum of the daily score throughout the 2 months(8 weeks in count) in evaluation period and divided with the days in diary."|Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52).|The analysis was performed in the Full Analysis Set.||units on a scale (Medication Score)||Standard Deviation|Mean
677989|NCT01603056|Primary|The Change From Baseline in Rhinoconjunctivitis Symptoms Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated.|"Subjects completed symptom assessments and recorded the results in the patient diary cards on a daily basis. A total of six rhinoconjunctivitis symptoms were measured on a scale from 0-3 as follows:
0 = No symptoms.
= Mild symptoms.
= Moderate symptoms. 3= Severe symptoms.
The six symptoms are classified in 2 groups as follows:
Nose symptoms: Runny nose, Blocked nose, Sneezing, Itchy nose; Eye symptoms: Gritty feeling/red/itchy eyes, Watery eyes. The six symptom scores were summed to obtain the rhinoconjunctivitis symptoms score with range 0(best) to 18(worst).
Baseline was set as 8 weeks before randomization as from V1 (Week -8) to V2 (Week 0). 11-12months’ end evaluation period was set from V8(Week 44) to V9(Week 52). These two average rhinoconjunctivitis symptoms scores (Baseline and 11-12months) were calculated for each patient as the sum of the daily score throughout the 2 months(8 weeks in count) in evaluation period and divided with the days with diary."|Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52).|The analysis was performed in the Full Analysis Set.||units on a scale (Symptom Score)||Standard Deviation|Mean
677990|NCT01603043|Secondary|Mean Change From Baseline in BCVA at Month 12|Efficacy analysis was not conducted due to the termination of the study prior to the primary and secondary efficacy endpoints and the small number of enrolled patients.|Baseline (Day 0), Month 12||||||
677991|NCT01603043|Secondary|Yearly GA Lesion Size Growth Rate|Efficacy analysis was not conducted due to the termination of the study prior to the primary and secondary efficacy endpoints and the small number of enrolled patients.|Baseline (Day 0), up to Month 12||||||
677992|NCT01603043|Primary|Mean Change From Baseline in GA Lesion Size at Month 12 as Assessed With FAF Imaging|Efficacy analysis was not conducted due to the termination of the study prior to the primary and secondary efficacy endpoints and the small number of enrolled patients.|Day 0 (injection visit), Month 12||||||
677993|NCT01602965|Primary|Weight Loss|The measure of weight must be detected with the help of a balance. Weight is measured using Professional Dial Column Scales without shoes or heavy clothing to the nearest 0.1 kg. Height is measured by a fixed stadiometer, without shoes, to the nearest 0.5 cm.|Percent Change in weight loss at one year|||percentage of weight loss||Standard Deviation|Mean
677994|NCT01602744|Primary|Functional Independence Measure (FIM)|Functioning was assessed by the FIM score. The FIM rates 18 activities of daily living on a 7 point scale ranging from fully dependent (=1) to independent (=7). A maximum score of 126 indicates functional independence and the lowest score of 18 indicates functional dependence.|Outcome measures were assessed at the end of the 12 month follow up|||units on a scale||Standard Deviation|Mean
677995|NCT01602744|Primary|Hospitalizations|The average number of hospitalizations per year.|Outcome measures were assessed at the end of the 12 month follow up|||Number of hospitalizations per year||Standard Deviation|Mean
677996|NCT01602744|Primary|Falls|Average number of falls per year.|At the end of the 12 month follow up|||Number of falls per year||Standard Deviation|Mean
678163|NCT01600495|Secondary|Duration From Start of Labor Until Birth|The length of time of labor, specified number of minutes since the opening of the partograph (early labor) until the birth of the child.|10 hours|Analyzing the duration of labor||min||Standard Deviation|Mean
678002|NCT01602562|Secondary|Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Screening and Day 35|The number of participants with normal, abnormal - clinically significant (CS), and abnormal - not clinically significant (NCS) ECG findings, as well as the number of participants with no results (NR), at Screening and Day 35 are presented. Findings were determined to be normal, abnormal CS, and NCS by the investigator.|Screening (SCR) and Day 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.||Participants|||Number
678003|NCT01602562|Secondary|Change From Baseline in Heart Rate at Days 0, 7, 14, 21, and 35|Heart rate is defined as the number of heartbeats per unit of time. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; Days 0, 7, 14, 21, and 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.||Beats per minute||Standard Deviation|Mean
678004|NCT01602562|Secondary|Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Days 0, 7, 14, 21, and 35|Blood pressure measurement included systolic blood pressure (SBP) and diastolic blood pressure (DBP). Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; Days 0, 7, 14, 21, and 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters/at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.||Millimeters of mercury||Standard Deviation|Mean
678005|NCT01602562|Secondary|Mean Urine Specific Gravity Values at Screening, Day 14, and Day 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.|Screening (SCR), Day 14, and Day 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.||ratio||Standard Deviation|Mean
678006|NCT01602562|Secondary|Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Screening, Day 14, and Day 35|Urinalysis parameters included: urine bilirubin (UB), urine occult blood (UOB), urine glucose (UG), urine ketones (UK), urine protein (UP), and urine urobilinogen (UUG). The dipstick is a strip used to detect the presence or absence of these parameters in the urine sample. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative (Neg), Trace, 1+, 2+, and 3+ (in order of increasing levels). Data are reported as the number of participants who had Neg, Trace, 1+, 2+, and 3+ levels at Screening, Day 14, and Day 35. If a category has not been reported for a specific parameter, then no participants were measured in that category.|Screening (SCR), Day 14, and 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters/at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.||Participants|||Number
678007|NCT01602562|Secondary|Mean Hemoglobin Values at Screening, Day 14, and Day 35|Blood samples were collected for the measurement of hemoglobin at Screening, Day 14, and Day 35.|Screening (SCR), Day 14, and Day 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.||Grams per liter (G/L)||Standard Deviation|Mean
678008|NCT01602562|Secondary|Mean Red Blood Cell Count at Screening, Day 14, and Day 35|Blood samples were collected for the measurement of the red blood cell count at Screening, Day 14, and Day 35.|Screening (SCR), Day 14, and Day 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.||tera (10^12) per liter (TI/L)||Standard Deviation|Mean
678009|NCT01602562|Secondary|Mean Platelet Count and White Blood Cell (WBC) Count at Screening, Day 14, and Day 35|Blood samples were collected for the measurement of platelet count and WBC count at Screening, Day 14, and Day 35.|Screening (SCR), Day 14, and Day 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters/at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.||giga (10^9) per liter (GI/L)||Standard Deviation|Mean
678010|NCT01602562|Secondary|Mean Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Screening, Day 14, and Day 35|Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, and total neutrophils at Screening, Day 14, and Day 35.|Screening (SCR), Day 14, and Day 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters/at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.||Percentage of cells in blood||Standard Deviation|Mean
678011|NCT01602562|Secondary|Mean Albumin and Total Protein Values at Screening, Day 14, and Day 35|Blood samples were collected for the measurement of albumin and total protein at Screening, Day 14, and Day 35.|Screening (SCR), Day 14, and Day 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters/at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.||Grams per liter (G/L)||Standard Deviation|Mean
678171|NCT01600482|Primary|The Primary Effectiveness Endpoint Will be Time to Hemostasis (TTH)|Time to hemostasis|With in the first 30 days +/- 7 days following the procedure|7 subjects in manual compression group where TTH was not recorded.||minutes||Standard Deviation|Mean
678012|NCT01602562|Secondary|Mean Cholesterol, Chloride, Glucose, Potassium, Sodium, Triglyceride, and Urea/Blood Urea Nitrogen (BUN) Values at Screening, Day 14, and Day 35|Blood samples were collected for the measurement of cholesterol, chloride, glucose, potassium, sodium, triglycerides, and urea/BUN at Screening, Day 14, and Day 35.|Screening (SCR), Day 14, and Day 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters/at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.||Millimoles per liter (mmol/L)||Standard Deviation|Mean
678013|NCT01602562|Secondary|Mean Direct Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Screening, Day 14, and Day 35|Blood samples were collected for the measurement of direct bilirubin, total bilirubin, creatinine, and uric acid at Screening, Day 14, and Day 35.|Screening (SCR), Day 14, and Day 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters/at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.||Micromoles per liter (µmol/L)||Standard Deviation|Mean
678014|NCT01602562|Secondary|Mean Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Phosphokinase (CPK), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LD) Values at Screening, Day 14, and Day 35|Blood samples were collected for the measurement of ALP, ALT, AST, CPK, GGT, and LD at Screening, Day 14, and Day 35.|Screening (SCR), Day 14, and Day 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters/at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.||International units per liter (IU/L)||Standard Deviation|Mean
678015|NCT01602562|Secondary|Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs and SAEs.|From Day -7 (7 days before HSCT) to Day 35 (35 days after HSCT)|Safety Population: All participants who received VACV more than once.||Participants|||Number
678016|NCT01602562|Primary|Number of Participants With a Herpes Simplex Virus (HSV) Infection|Viral isolation/identification was conducted if the investigator (or subinvestigator) suspected HSV infection according to the relevant clinical symptoms (oral mucositis, skin infection, genital herpes, and pneumonia). If the result of viral isolation/identification was positive, the participant concerned was defined as a case of HSV infection. For reference, a virus deoxyribonucleic acid (DNA) identification (PCR) was simultaneously performed.|From Day -7 (7 days before HSCT) to Day 35 (35 days after HSCT)|Full Analysis Set (FAS): all participants who were given VACV more than once and who could provide data evaluable with respect to the occurrence of HSV infection.||Participants|||Number
678017|NCT01602549|Secondary|GSK962040 Tmax at Day1 and Day 8|GSK962040 tmax was derived from GSK962040 plasma concentration-time data. Only participants who received GSK962040 50 mg were analyzed.|Day 1 and Day 8|PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed.||Hours||Full Range|Median
678018|NCT01602549|Secondary|GSK962040 Cmax at Day1 and Day 8|GSK962040 Cmax was derived from GSK962040 plasma concentration-time data. Only participants who received GSK962040 50 mg were analyzed.|Day 1 and Day 8|PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed.||Nanograms/milliliter||Geometric Coefficient of Variation|Geometric Mean
678019|NCT01602549|Secondary|GSK962040 Percentage of AUC(0-inf) Obtained by Extrapolation (%AUCex) at Day 1|GSK962040 %AUCex was derived from GSK962040 plasma concentration-time data. %AUCex is the percentage of the AUC(0-inf) extrapolated from the last PK sample drawn to infinity. This parameter is only reported in conjunction with single-dose AUC(0-inf). Only participants who received GSK962040 50 mg were analyzed. AUC is a measure of levodopa exposure.|Day 1|PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed.||Percentage||Geometric Coefficient of Variation|Geometric Mean
678020|NCT01602549|Secondary|GSK962040 Area Under the Plasma Concentration-time Curve From Zero to 5.5 Hours (AUC[0-5.5] and Area Under the Plasma Concentration-time Curve From Zero to Infinity (AUC[0-inf]) at Days 1 and 8|GSK AUC(0-5.5) and AUC(0-inf) were derived from GSK962040 plasma concentration-time data. Only participants who received GSK962040 50 mg were analyzed. AUC is a measure of levodopa exposure. Data for AUC(0-inf) was analyzed and was only available for Day 1 and not for Day 8.|Day 1 and Day 8|PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed.||Nanograms.hour/milliliter||Geometric Coefficient of Variation|Geometric Mean
678021|NCT01602549|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, is a congenital anomaly or birth defect, is associated with liver injury and impaired liver function, or are serious events as per the medical or scientific judgment.|From the start of study medication until Follow-up (up to Day 25)|All Subjects Population||Participants|||Number
678022|NCT01602549|Secondary|Change From Baseline in Reticulocytes (RET) at Day 4 and Day 8|RET measurements were taken at pre-dose on Day 1 (Baseline), Day 4, and Day 8. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline, Day 4, and Day 8|ASP. Participants with available data (n=X, X in category titles) were analyzed.||Tera (10^12) cells per liter||Standard Deviation|Mean
678023|NCT01602549|Secondary|Change From Baseline in Red Blood Cell Count (RBC) and White Blood Cell Count (WBC) at Day 4 and Day 8|RBC and WBC measurements were taken at pre-dose on Day 1 (Baseline), Day 4, and Day 8. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline, Day 4, and Day 8|ASP. Participants with available data (n=X, X in category titles) were analyzed.||Giga (10^9) cells per liter||Standard Deviation|Mean
678024|NCT01602549|Secondary|Change From Baseline in Mean Corpuscle Volume (MCV) at Day 4 and Day 8|MCV measurements were taken at pre-dose on Day 1 (Baseline), Day 4, and Day 8. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline, Day 4, and Day 8|ASP. Participants with available data (n=X, X in category titles) were analyzed.||Femtoliters||Standard Deviation|Mean
678025|NCT01602549|Secondary|Change From Baseline in Mean Corpuscle Hemoglobin (MCH) at Day 4 and Day 8|MCH measurements were taken at pre-dose on Day 1 (Baseline), Day 4, and Day 8. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline, Day 4, and Day 8|ASP. Participants with available data (n=X, X in category titles) were analyzed.||Picograms||Standard Deviation|Mean
678026|NCT01602549|Secondary|Change From Baseline in Hematocrit at Day 4 and Day 8|Hematocrit measurements were taken at pre-dose on Day 1 (Baseline), Day 4, and Day 8. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline, Day 4, and Day 8|ASP. Participants with available data (n=X, X in category titles) were analyzed.||proportion of 1||Standard Deviation|Mean
678027|NCT01602549|Secondary|Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at Day 4 and Day 8|Hemoglobin and MCHC measurements were taken at pre-dose on Day 1 (Baseline), Day 4, and Day 8. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline, Day 4, and Day 8|ASP. Participants with available data (n=X, X in category titles) were analyzed.||Grams per liter||Standard Deviation|Mean
678028|NCT01602549|Secondary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Absolute Neutrophil Count (ANC), and Platelet Count (PC) at Day 4 and Day 8|Basophils, eosinophils, lymphocytes, monocytes, total ANC, and PC measurements were taken at pre-dose on Day 1 (Baseline), Day 4, and Day 8. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline, Day 4, and Day 8|ASP. Participants with available data (n=X, X in category titles) were analyzed.||Giga (10^9) cells per liter||Standard Deviation|Mean
678029|NCT01602549|Secondary|Change From Baseline in Calcium, Chloride, Carbon Dioxide Content (CO2)/Bicarbonate (BC), Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN), and Uric Acid (UA) at Day 4 and Day 8|Calcium, chloride, CO2/BC, glucose, potassium, sodium, urea/BUN, and UA measurements were taken at pre-dose on Day 1 (Baseline), Day 4, and Day 8. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline, Day 4, and Day 8|ASP. Participants with available data (n=X, X in category titles) were analyzed.||Millimoles per liter||Standard Deviation|Mean
678030|NCT01602549|Secondary|Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), and Gamma Glutamyl Transferase (GGT) at Day 4 and Day 8|ALP, ALT, AST, and GGT measurements were taken at pre-dose on Day 1 (Baseline), Day 4, and Day 8. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline, Day 4, and Day 8|ASP. Participants with available data (n=X, X in category titles) were analyzed.||International units per liter||Standard Deviation|Mean
678031|NCT01602549|Secondary|Change From Baseline in Albumin (ALB) and Total Protein (TP) at Day 4 and Day 8|ALB and TP measurements were taken at pre-dose on Day 1 (Baseline), Day 4, and Day 8. Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline, Day 4, and Day 8|ASP. Participants with available data (n=X, X in category titles) were analyzed.||Grams per liter||Standard Deviation|Mean
678032|NCT01602549|Secondary|Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Day 1 and Day 8|ECG measurements were taken at pre-dose and 0 min (completion of meal) on Day 1 and Day 8. The Baseline value was the Day 1 pre-dose value. ECG findings were categorized as normal, abnormal - not clinically significant, and abnormal - clinically significant (CS), based on interpretation by the site.|Day 1 and Day 8|ASP. Participants with available data (n=X, X in category titles) were analyzed.||Participants|||Number
678033|NCT01602549|Secondary|Change From Baseline in Heart Rate at Day 1 and Day 8|Heart rate measurements were taken at pre-dose and 0 min (completion of meal) on Day 1 and Day 8. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline, Day 1, and Day 8|ASP. Participants with available data (n=X, X in category titles) were analyzed.||Beats per minute||Standard Deviation|Mean
678034|NCT01602549|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Day 1 and Day 8|Blood pressure measurements were taken at pre-dose and at 0 min (completion of meal) on Day 1 and Day 8. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline, Day 1, and Day 8|All Subjects Population (ASP): all participants who received >=1 dose of study medication. Participants with available data (n=X, X in category titles) were analyzed.||Millimeters of mercury||Standard Deviation|Mean
678035|NCT01602549|Secondary|Total Daily L-DOPA Equivalent Dose at Baseline and on Days 1, 2, 3, 4, 5, 6, 7, 8, and 9|Various formulations of L-DOPA were utilized by participants for the treatment of Parkinson’s Disease. The total daily L-DOPA equivalent dose was calculated as the sum of all L-DOPA equivalent doses for each L-DOPA-containing drug taken on the same day.|Baseline and Days 1, 2, 3, 4, 5, 6, 7, 8, and 9|PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed.||Milligrams||Standard Deviation|Mean
678172|NCT01600482|Primary|The Primary Safety Endpoint Will be the Combined Rate of Major Complications With in 30 +/- 7 Days Following the Percutaneous Coronary Intervention (PCI) Procedure.|rate of major complications with in 30 +/- 7 days following the PCI procedure.|With in the first 30 days +/- 7 days following the procedure|||major complications|||Number
678036|NCT01602549|Secondary|Number of Times a Participant Could Alternatively Tap Two Counter Keys 30 Centimeters Apart in 1 Minute (Min) at Baseline, Day1, Day 8, and Follow-up|Participants were asked to alternatively tap two keys 30 centimeters apart in 1 minute in two trials with the most affected hand or the dominant hand in symmetric disease. The finger tapping was scored manually by the study staff. The finger-tapping assessment was repeated at eight separate time points (pre-dose, 0 min, 30 min, 60 min, 90 min, 120 min, 180 min, and 240 min post-dose) at each visit (Baseline, Day 1, and Day 8). At each time point, the mean of the two assessments was calculated.|Baseline, Day 1, and Day 8 at pre-dose and 0, 30, 60, 90, 120, 180, and 240 minutes post-dose; Follow-up visit (up to Day 25)|PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed.||Finger taps per minute||Standard Deviation|Mean
678037|NCT01602549|Secondary|"Period Mean Amount of Hours Spent “ON,” “ON” Without Dyskinesia, ON With Non-troublesome Dyskinesia, ON With Troublesome Dyskinesia, and “OFF” at Baseline and During the Treatment Period (Days 1-8), Week 1 of Follow-up, and Week 2 of Follow-up"|"Participants were provided with the ON/OFF diary to capture details of the amount of awake time spent on/off of PD symptoms, and were asked to complete the diary daily. Participants checked the box most appropriate for their dominant motor state in the preceding 30-minute period. The catergories included: ON (including “ON without dyskinesia” and “ON with non-troublesome dyskinesia), ON with troublesome dyskinesia (TD), and OFF. For Baseline, data were collected for 2 days prior to Day 1, and the mean value of the 2 days was used."|Baseline, Days 1-8, Week 1 of Follow-up (Days 6 and 7 of Follow-up; up to Day 16), and Week 2 of Follow-up (Days 13 and 14 of Follow-up; up to Day 23)|PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed.||hours||Standard Deviation|Mean
678038|NCT01602549|Secondary|Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Scores at Baseline, Day 1, and Day 8 (Pre-dose; 120, 180, and 240 Minutes Post-dose)|The MDS-UPDRS is used to assess the status of Parkinson's Disease. It has four parts: Part I (non-motor experiences of daily living), Part II (motor experiences of daily living), Part III (motor examination), and Part IV (motor complications). Each part is made up of several questions, with each question given a score ranging from 0 (normal) to 4 (severe). Part I and Part II consist of 13 items each, and have a score ranging between 0 (normal) and 52 (severe). Part III consists of 33 items, and has a score ranging between 0 (normal) and 132 (severe). Part IV consists of 6 items, and has a score ranging between 0 (normal) and 24 (severe). The total score is the summed score of all four parts and ranges between 0 (normal) and 260 (severe). A higher score indicates more severe symptoms.|Baseline, Day 1, and Day 8 at pre-dose and 120, 180, and 240 minutes (min) post-dose (PD); Follow-up visit (up to Day 25)|PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed.||Scores on a scale||Standard Deviation|Mean
678039|NCT01602549|Secondary|Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Scores at Baseline, Day 1, and Day 8 (Pre-levodopa Dose)|The MDS-UPDRS is used to assess the status of Parkinson's Disease. It has four parts: Part I (non-motor experiences of daily living), Part II (motor experiences of daily living), Part III (motor examination), and Part IV (motor complications). Each part is made up of several questions, with each question given a score ranging from 0 (normal) to 4 (severe). Part I and Part II consist of 13 items each, and have a score ranging between 0 (normal) and 52 (severe). Part III consists of 33 items, and has a score ranging between 0 (normal) and 132 (severe). Part IV consists of 6 items, and has a score ranging between 0 (normal) and 24 (severe). The total score is the summed score of all four parts and ranges between 0 (normal) and 260 (severe). A higher score indicates more severe symptoms.|Baseline, Day 1, and Day 8 at pre-levodopa dose|PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed.||Scores on a scale||Standard Deviation|Mean
678040|NCT01602549|Secondary|Gastric Half Emptying Time (GE t1/2) at Baseline (BL), Day 1, and Day 8|Gastric half emptying time is the time taken for half the contents of the stomach to empty. Gastric emptying was measured using the 13C-oral breath test, which is a tracer method that utilizes 13C, a non-radioactive isotope. Basal breath samples were obtained after an overnight fast or otherwise after 4 hours of fasting following a light meal. On Day 1 and Day 8, participants were then dosed with GSK962040 and additional breath test samples were taken prior to administration of a 13C-labelled test meal. The test meal was consumed approximately 80 minutes later. After consumption of the test meal, breath samples were collected at pre-specified time points over an approximately 4 hour period following the test meal. For the duration of the breath test, no food or drink were allowed. The 13C breath content was determined by isotope ratio mass spectrometry. GE t1/2 was determined by using the cumulative percentage of the administered dose of 13C excreted in breath over 4 hours.|Baseline, Day 1, and Day 8|PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed.||Minutes||Standard Deviation|Mean
678041|NCT01602549|Primary|L-DOPA Terminal Phase Half-life (t1/2) at Baseline, Day 1, and Day 8|L-DOPA t1/2 was derived from L-DOPA plasma concentration-time data. This endpoint was not assessed because there were insufficient L-DOPA data/profiles to calculate this parameter.|Baseline, Day 1, and Day 8||||||
678042|NCT01602549|Primary|L-DOPA Time of Occurrence of Cmax (Tmax) at Baseline, Day 1,and Day 8|L-DOPA Tmax was derived from L-DOPA plasma concentration-time data.|Baseline, Day 1, and Day 8|PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed.||Hours||Full Range|Median
678043|NCT01602549|Primary|Dose-normalized L-DOPA Cmax at Day 1 and Day 8|Dose-normalized L-DOPA Cmax was derived from L-DOPA plasma concentration-time data. The adjusted means and ratios were estimated using a mixed model fitting treatment, visit, treatment*visit, Baseline L-dopa PK parameter, and Baseline gastric emptying half-time as fixed effects, and participant as a random effect.|Day 1 and Day 8|PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed.||Nanograms/milliliter/milligram||Standard Error|Least Squares Mean
678044|NCT01602549|Primary|Dose-normalized L-DOPA Maximum Observed Concentration (Cmax) at Baseline|Dose-normalized L-DOPA Cmax was derived from L-DOPA plasma concentration-time data.|Baseline|PD/Efficacy Population. Only those participants available at the specified time point were analyzed.||Nanograms/milliliter/milligram||Geometric Coefficient of Variation|Geometric Mean
678173|NCT01600326|Secondary|Number of Participants Showing Symptomatic Improvement as Assessed in Patient Chart|Information from patient charts were retrospectively reviewed to determine if symptoms were reported as improved, worse, or no change over a time period (range 15 to 555 days post treatment).|15 to 555 days post treatment|||Participants|||Count of Participants
678045|NCT01602549|Primary|Dose-normalized L-DOPA AUC(0-4) at Day 1 and Day 8|Dose-normalized L-DOPA AUC(0-4) was derived from L-DOPA plasma concentration-time data. The adjusted means and ratios (GSK962040 50 mg: Placebo) were estimated using a mixed model fitting treatment, visit, treatment*visit, Baseline L-dopa pharmacokinetic (PK) parameter, and Baseline gastric emptying half-time as fixed effects, and participant as a random effect. AUC is a measure of levodopa exposure|Day 1 and Day 8|PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed.||Nanograms*hour/milliliter/milligram||Standard Error|Least Squares Mean
678046|NCT01602549|Primary|Dose-normalized Levodopa (L-DOPA) Area Under the Plasma Concentration-time Curve From Zero to 4 Hours AUC(0-4) at Baseline|Dose-normalized L-DOPA AUC(0-4) was derived from L-DOPA plasma concentration-time data. AUC is a measure of levodopa exposure.|Baseline|Pharmacodynamic (PD)/Efficacy Population: participants receiving >=1 dose placebo/GSK962040 50 mg. Only those participants available at the specified time point were analyzed.||Nanograms*hour/milliliter/milligram||Geometric Coefficient of Variation|Geometric Mean
678047|NCT01602510|Secondary|Change From Baseline in Body Weight|Participant’s body weight was measured on Weeks 0, 4, 8, 12, 16, 20, 24, 32 and 36. Analysis was performed using ANCOVA with covariates of site, CGI-S baseline score, treatment and baseline body weight. In presented LOCF datasets, the last non-missing on therapy score prior to TIME was carried forward to estimate missing data points for the remaining study visits of the treatment period. The baseline value was defined as the last non-missing values at or prior to the randomization. The change from baseline at the time point of interest was calculated by subtracting the baseline values from the individual post-baseline values. If either the baseline or post-baseline value was missing, the change from baseline was set to missing as well.|Baseline and up to 36 weeks.|RD Full Analysis Population. Only those par. with available data at indicated time points were analyzed.||Kilograms||Standard Error|Least Squares Mean
678048|NCT01602510|Secondary|Change From Baseline of Global Assessment Scale (GAS) Total Score|For GAS, investigators rated par. for lowest level of functioning during the previous week. The scale has a 10 score categories: 1-10, 11-20, 21-30, 31-40, 41-50, 51-60, 61-70, 71-80, 81-90, 91-100, using intermediary levels when appropriate (from 100 to 1, Lower is worse.). Data was collected on Weeks 0, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 32, 36. Analysis was performed using ANCOVA with covariates of site, CGI-S BL score, treatment and GAS total BL score. In presented LOCF datasets, the last non-missing on therapy score prior to TIME was carried forward to estimate missing data points for the remaining study visits of the treatment period. The BL value was defined as the last non-missing values at or prior to the randomization. The change from BL at the time point of interest was calculated by subtracting the BL values from the individual post-BL values. If either the BL or post-BL value was missing, the change from BL was set to missing as well.|Baseline and up to 36 weeks|RD Full Analysis Population||Score on a scale||Standard Error|Least Squares Mean
678049|NCT01602510|Secondary|Change From Baseline in Young Mania Rating Scale (YMRS) Total Score|YMRS consists of 11 items: Elevated Mood, Increased Motor Activity/Energy, Sexual Interest, Sleep, Irritability, Speech, Language/Thought Disorder, Content, Disruptive/Aggressive Behaviour, Appearance, and Insight. Investigators rated par. from 0 to 4 (or 8) for each of these items. Total score is the sum of all subscales, from 0 to 60 (higher is worse). Data was collected on Wks 0, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 32, 36. Analysis was performed using ANCOVA with covariates of site, CGI-S BL score, treatment and YMRS total BL score. In LOCF datasets, the last non-missing OT score prior to TIME was carried forward to estimate missing data points for the remaining study visits of the treatment period. BL value was defined as the last non-missing values at or prior to the randomization. Change from BL at the time point of interest was calculated by subtracting BL value from the individual post-BL value. If either the BL or post-BL value was missing, change from BL was set to missing.|Baseline and up to 36 weeks|RD Full Analysis Population||Score on a scale||Standard Error|Least Squares Mean
678050|NCT01602510|Secondary|Change From Baseline in Hamilton Depression Rating Scale (HAMD)|HAMD consists of 17 items: depressed mood, feelings of guilt, suicide, insomnia-early, middle, late, work and activities, retardation, agitation, anxiety psychic, anxiety somatic, somatic symptoms gastro-intestinal, general somatic symptoms, hypochondriasis, loss of weight, and insight. Investigators rated par. from 0 to 4 (or 2) for these items. Total score is sum of all subscales (0 to 52, higher is worse). Data was collected on Wks 0, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 32, 36. Analysis was performed using ANCOVA with covariates of site, CGI-S baseline (BL) score, treatment and HAMD total BL score. The last non-missing OT score prior to TIME was carried forward to estimate missing data points for remaining study visits of the treatment period. BL value was defined as the last non-missing value at or prior to the randomization. Change from BL was calculated by subtracting BL from the specific post-BL value. If BL or post-BL value was missing, the change from BL was set to missing.|Baseline and up to 36 weeks|RD Full Analysis Population||Score on a scale||Standard Error|Least Squares Mean
678051|NCT01602510|Secondary|Change From Baseline in Clinical Global Impression of Severity (CGI-S)|The CGI-S is a 7-point scale where investigator were asked to rate the severity of the participant’s illness at the time of assessment on severity of mental illness, where 1= normal, and 7= extremely ill. Data was collected on Weeks 0, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 32 and 36. Analysis performed using Analysis of Covariance (ANCOVA) with covariates of site, CGI-S baseline score (Open label phase), treatment and CGI-S baseline score. In presented Last observation carried forward (LOCF) datasets, last non-missing on therapy score prior to TIME was carried forward to estimate missing data points for remaining study visits of treatment period. The baseline value was defined as last non-missing values at or prior to the randomization. The change from baseline at the time point of interest was calculated by subtracting the baseline values from individual post-baseline values. If either the baseline or post-baseline value was missing, the change from baseline was set to missing as well.|Baseline and up to 36 weeks|RD Full Analysis Population.||Score on a scale||Standard Error|Least Squares Mean
678070|NCT01602380|Primary|Comparison of Progression Free Survival (PFS) in Patients Treated With Fulvestrant With Those Treated With Anastrozole|PFS was defined as the time from randomisation until objective disease progression according to Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1), surgery or radiotherapy to manage worsening of disease or death by any cause (in the absence of progression). Outcome measure is reported as median time from randomisation to PFS, calculated using the Kaplan-Meier technique.|Baseline RECIST 1.1 assessments and then every 12 weeks until the earliest of disease progression evident, patient dies or has surgery/radiotherapy for their disease (up to approximately 38 months for the primary analysis data cut-off).|The ITT analysis set included all randomised patients.||Months||95% Confidence Interval|Median
678052|NCT01602510|Secondary|Change From Baseline in Clinical Global Impression of Improvements (CGI-I)|The CGI-I is a 7-point scale where investigator were asked to assess the participant’s illness at the time of assessment (improved or worsened) relative to a baseline state. In this scale, 1= very much improved; 2= much improved; 3= minimally improved; 4= no change; 5= minimally worse; 6= much worse; or 7= very much worse. Analysis was performed using Analysis of covariance with covariates of site, CGI-S baseline score and treatment. In presented Last-observation-carried-forward datasets, the last non-missing on therapy (OT) score prior to TIME was carried forward to estimate missing data points for the remaining study visits of the treatment period. Baseline value was defined as the last non-missing values at or prior to the randomization. Change from baseline at the time point of interest was calculated by subtracting the baseline values from the individual post-baseline values. If either baseline or post-baseline value was missing, the change from baseline was set to missing.|Baseline and up to 36 weeks|RD Full Analysis Population.||Score on a scale||Standard Error|Least Squares Mean
678053|NCT01602510|Secondary|Overall Survival in Study (TIME-SIS).|TIME-SIS was defined as the time to intervention (addition of pharmacotherapy or ECT) for any mood episode, or to the time when the participant is withdrawn for any reason after randomization. The premature discontinuation of a participant prior to reaching TIME, for any reason, was treated as an event related to bipolar disorder. All participants prematurely discontinued prior to the TIME event in this analysis were to be assumed to have reached TIME. TIMS-SIS was analyzed using Cox proportional hazards regression model with covariates of site, CGI-S baseline score, treatment and treatment by CGI-S baseline score interaction. The overall hazard ratio for treatment group could not be calculated due to different CGI-S baseline score level. Par. prematurely discontinued from the study prior to reaching the event were censored at the time of discontinuation.|36 weeks|"RD Full Analysis Population. NA implies no data are available. Only those par. with available data at indicated time points were analyzed."||Days||95% Confidence Interval|Median
678054|NCT01602510|Secondary|Time to Intervention for Depressive Episode (TIDep)|TIDep was analyzed using Cox proportional hazards regression model with covariates of site, CGI-S baseline score, treatment and treatment by CGI-S baseline score interaction. The overall hazard ratio for treatment group could not be calculated due to different CGI-S baseline score level. Par. prematurely discontinued from the study prior to reaching the event were censored at the time of discontinuation.|36 weeks|"RD Full Analysis Population. NA implies no data are available. Only those par. with available data at indicated time points were analyzed."||Days||95% Confidence Interval|Median
678055|NCT01602510|Secondary|Time to Intervention for Manic, Hypomanic or Mixed Episode (TIMan)|TIMan was analyzed using using Cox proportional hazards regression model with covariates of site, CGI-S baseline score, treatment and treatment by CGI-S baseline score interaction. The overall hazard ratio for treatment group could not be calculated due to different CGI-S baseline score level. Par. prematurely discontinued from the study prior to reaching the event were censored at the time of discontinuation.|36 weeks|"RD Full Analysis Population.NA implies no data are available. Only those par. with available data at indicated time points were analyzed."||Days||95% Confidence Interval|Median
678056|NCT01602510|Primary|Time to Intervention for Any Mood Episode (TIME)|TIME is defined as being the time from entry into the randomized double-blind phase to the time of the first prescription of any additional pharmacotherapy or Electroconvulsive therapy (ECT) determined by the investigator to be necessary for treatment of a relapse and/or recurrence of a depressive, manic, hypomanic or mixed episode, whichever occurs first. TIME was measured relative to randomization date. Par. prematurely discontinued from the study prior to reaching the TIME event were censored at the time of discontinuation. Analysis was performed using Cox proportional hazards regression model with covariates of site, CGI-S baseline score, treatment and treatment by CGI-S baseline score interaction. The overall hazard ratio for treatment group could not be calculated due to different CGI-S baseline score level.|36 weeks (wks)|"Randomized (RD) Full analysis population: comprised of all randomized par. who took at least one dose of study medication and had at least one post-baseline efficacy/health outcomes assessment during randomized double-blind phase. NA implies no data are available. Only those par. with available data at indicated time points were analyzed."||Days||95% Confidence Interval|Median
678057|NCT01602484|Secondary|Time to Apply Splint|Time it takes to apply splint|Immediately following the operation, beginning with when medical personnel finish preparing supplies and ending when the splint is applied (approximately 3 minutes)|One patient from the bulk supply group because the subject's splinting was interrupted secondary to airway issues not related to the study.||seconds||95% Confidence Interval|Mean
678058|NCT01602484|Secondary|Time to Prepare Splint|Time it takes to prepare splint supplies prior to splint application|Immediately following the operation, beginning with when medical personnel finish gathering supplies and ending when the materials are prepared to apply splint (approximately 2 minutes)|One patient from the bulk supply group because the subject's splinting was interrupted secondary to airway issues not related to the study.||seconds||95% Confidence Interval|Mean
678059|NCT01602484|Secondary|Time to Gather Supplies|Time it takes to gather supplies prior to splint application|Immediately following the operation, beginning with when medical personnel start to gather supplies and ending when they finish gathering supplies (approximately 1 minute)|One patient from the bulk supply group because the subject's splinting was interrupted secondary to airway issues not related to the study.||seconds||95% Confidence Interval|Mean
678060|NCT01602484|Primary|Total Splint Application Time|Time it takes to apply post-op splint|Immediately following the operation, beginning at the start of gathering splint supplies and ending when splint application is completed (approximately five total minutes)|One patient from the bulk supply group because the subject's splinting was interrupted secondary to airway issues not related to the study.||seconds||95% Confidence Interval|Mean
678061|NCT01602471|Primary|[F-18]RDG-K5 Uptake by Carotid Plaque on PET Scan|Based on the small sample size and lack of IHC analyses, no efficacy conclusions can be drawn from this study.|Participants will be followed for an average of 6 weeks||||||
678081|NCT01602198|Primary|Change in BOLD Response on Functional Magnetic Resonance Imaging (fMRI)||baseline and 6 months|Trial was terminated prematurely after enrollment of only 1 participant. Sample size is insufficient for BOLD response analysis.|||||
678062|NCT01602380|Secondary|Comparison of the Effect of Fulvestrant Treatment Versus Anastrozole Treatment on Time to Deterioration of Health Related Quality of Life (HRQoL)|The Functional Assessment of Cancer Therapy - Breast (FACT-B) questionnaire was the instrument selected to assess HRQoL and comprises the following subscales: physical well-being (PWB), functional well-being (FWB), social well-being, emotional well-being, and breast cancer subscale (BCS). The main outcome measure from the FACT-B questionnaire was the Trial Outcome Index (TOI), which was a summary of the following subscales: PWB, FWB, and BCS. Outcome measure is reported as median time to deterioration, defined as the interval from the date of randomisation to the first assessment of worsened without an improvement in the next 12 weeks in FACT-B TOI, or the date of death (by any cause in the absence of symptom deterioration). Time to deterioration as measured by FACT-B total score was derived similarly and is also reported.|Quality of life questionnaires completed at baseline and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months for the primary analysis data cut-off).|The ITT analysis set included all randomised patients.||months||Inter-Quartile Range|Median
678063|NCT01602380|Secondary|Expected Duration of Clinical Benefit (EDoCB) for Fulvestrant Treatment Versus Anastrozole Treatment|EDoCB was estimated using the formula EDoCB = p Efp(x), where x = EDoCB, p = proportion of responders, and Efp(x) = mean duration of response for responders. The estimation was completed by using the maximum likelihood estimates of p and Efp(x), as described by Ellis (Ellis S et al. Analysis of duration of response in oncology trials, Contemp Clin Trials 2008; 29:456–65).|Baseline RECIST 1.1 assessments and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months for the primary analysis data cut-off).|The ITT analysis set included all randomised patients.||Days|||Number
678064|NCT01602380|Secondary|Duration of Clinical Benefit (DoCB) for Fulvestrant Treatment Versus Anastrozole Treatment|DoCB was defined only for patients who had clinical benefit, as the time in days from date of randomisation until the date of disease progression.|Baseline RECIST 1.1 assessments and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months for the primary analysis data cut-off).|Only patients in the ITT analysis set (which included all randomised patients) who also had a clinical benefit were included in the DoCB analysis (n=180 for Fulvestrant arm and n=172 for Anastrozole arm).||Months||Inter-Quartile Range|Median
678065|NCT01602380|Secondary|Clinical Benefit Rate (CBR) for Fulvestrant Treatment Versus Anastrozole Treatment|CBR was defined as the percentage of patients who had a clinical benefit (i.e. best objective response of CR, PR or stable disease), that was maintained for at least 24 weeks, prior to any evidence of progression. Note that a minimum duration of 22 weeks for CBR was applicable in the analysis (rather than 24 weeks) to allow for the protocolled window of +/-2 weeks.|Baseline RECIST 1.1 assessments and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months for the primary analysis data cut-off).|The ITT analysis set included all randomised patients.||Percentage of participants|||Number
678066|NCT01602380|Secondary|Expected Duration of Response (EDoR) for Fulvestrant Treatment Versus Anastrozole Treatment|EDoR was estimated using the formula EDoR = p Efp(x), where x = DoR, p = proportion of responders, and Efp(x) = mean duration of response for responders. The estimation was completed by using the maximum likelihood estimates of p and Efp(x), as described by Ellis (Ellis S et al. Analysis of duration of response in oncology trials, Contemp Clin Trials 2008; 29:456–65).|Baseline RECIST 1.1 assessments and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months for the primary analysis data cut-off).|EDoR analysis was based on the number of patients in the ITT analysis set (which included all randomised patients) who had measurable disease at baseline (n=193 for Fulvestrant arm and n=196 for Anastrozole arm).||Days|||Number
678067|NCT01602380|Secondary|Duration of Response (DoR) for Fulvestrant Treatment Versus Anastrozole Treatment|DoR was defined only for patients who had an objective response, as the time in days from date of first documentation of response (CR/PR) until date of disease progression.|Baseline RECIST 1.1 assessments and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months for the primary analysis data cut-off)..|Only patients in the ITT analysis set (which included all randomised patients), who also had an objective response and had measurable disease at baseline were included in the DoR analysis (n=89 for Fulvestrant arm and n=88 for Anastrozole arm).||Months||Inter-Quartile Range|Median
678068|NCT01602380|Secondary|Objective Response Rate (ORR) for Fulvestrant Treatment Versus Anastrozole Treatment|ORR was defined as the percentage patients with an objective response (i.e. those recording a partial response [PR] or complete response [CR]) at some point during the study, prior to disease progression. ORR was assessed in patients with measurable disease at baseline only. The determination of measurable disease at baseline was done using baseline RECIST data.|Baseline RECIST 1.1 assessments and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months for the primary analysis data cut-off).|Percentages for ORR were calculated based on the number of patients in the ITT analysis set (which included all randomised patients) who had measurable disease at baseline (n=193 for Fulvestrant arm and n=196 for Anastrozole arm).||Percentage of participants|||Number
678069|NCT01602380|Secondary|Comparison of Overall Survival (OS) in Patients Treated With Fulvestrant With Those Treated With Anastrozole; Percentage of Patients With Events|OS was defined as the time from randomisation until death by any cause. Two timepoints were planned for OS analysis: an interim OS analysis at the time of the data cut-off for PFS analysis and a final OS analysis when 50% of the deaths have occurred. The current OS data correspond to that of the interim analysis only and the outcome measure is reported as percentage of patients with events.|Baseline up to data cut-off for PFS analysis (up to approximately 38 months). Following disease progression, patients were to be contacted at 12 weekly intervals to to determine survival status.|The ITT analysis set included all randomised patients.||Percentage of participants|||Number
678071|NCT01602341|Secondary|Improvement From Baseline in ADSI Component Scores (Erythema, Pruritus, Exudation, Excoriation and Lichenification) at Day 8, 15, 22 and 29|ADSI was used to assess the severity of atopic dermatitis (AD) based on five subscale scores of erythema, pruritus, exudation, excoriation, and lichenification. The severity of each subscale was measured on a 4-point scale ranging from 0 (none) to 3 (severe), where higher scores indicating more severity. ADSI was calculated as the sum of these 5 subscale scores with a total possible score range of 0 (none) to 15 (most severe) where, higher scores indicating more severity. Improvement from baseline was calculated as baseline evaluation minus the follow-up evaluation.|Baseline, Day 8, 15, 22, 29|ITT population included all participants who were randomized and received study drug.||units on a scale||Standard Deviation|Mean
678072|NCT01602341|Secondary|Number of Participants With Local Tolerability Symptoms|Participants who experienced local tolerability symptoms: mild itching or burning/stinging at sites of study drug application were reported in this measure.|Baseline up to Day 29|Safety population included all participants who were randomized and applied at least 1 confirmed dose of study drug.||Participants|||Count of Participants
678073|NCT01602341|Secondary|Number of Participants With Treatment-Emergent Adverse Events By Severity|AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed on basis of severity as follows: mild=does not interfere with participant's usual function; moderate=interferes to some extent with participant's usual function; severe=interferes significantly with participant's usual function. Number of participants with mild, moderate and severe treatment-emergent AEs were reported in this outcome measure.|Baseline up to Day 29|Safety population included all participants who were randomized and applied at least 1 confirmed dose of study drug.||Participants|||Count of Participants
678074|NCT01602341|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; Initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug to the end of study treatment (Day 29), that were absent before treatment or that worsened relative to pre-treatment state.|Baseline up to Day 29|Safety population included all participants who were randomized and applied at least 1 confirmed dose of study drug.||Participants|||Count of Participants
678075|NCT01602341|Secondary|Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities|Laboratory parameters included: hematology (hemoglobin, hematocrit, red blood cell, platelet and white blood cell count, neutrophils, eosinophils, monocytes, basophils and lymphocytes), chemistry (blood urea nitrogen, creatinine, sodium, potassium, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, albumin, total protein and serum pregnancy test [for all female participants]) and urine (urine pregnancy test [for all female participants]). Clinical significance of laboratory parameters was determined at the investigator's discretion.|Baseline up to Day 29|Safety population included all participants who were randomized and applied at least 1 confirmed dose of study drug.||Participants|||Count of Participants
678076|NCT01602341|Secondary|Number of Participants With Clinically Significant Change From Baseline in Vital Signs|Vital signs (temperature, respiratory rate, pulse, systolic and diastolic blood pressure) were obtained with participant in the seated position, after having sat calmly for at least 5 minutes. Clinical significance of vital signs was determined at the investigator's discretion.|Baseline up to Day 29|Safety population included all participants who were randomized and applied at least 1 confirmed dose of study drug.||Participants|||Count of Participants
678077|NCT01602341|Primary|Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 29|ADSI was used to assess the severity of atopic dermatitis (AD) based on five subscale scores of erythema, pruritus, exudation, excoriation, and lichenification. The severity of each subscale was measured on a 4-point scale ranging from 0 (none) to 3 (severe), where higher scores indicating more severity. ADSI was calculated as the sum of these 5 subscale scores with a total possible score range of 0 (none) to 15 (most severe) where, higher scores indicating more severity. Improvement from Baseline was calculated as Baseline score minus follow-up score.|Baseline, Day 29|ITT population included all participants who were randomized and received study drug.||units on a scale||Standard Deviation|Mean
678078|NCT01602341|Primary|Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 22|ADSI was used to assess the severity of atopic dermatitis (AD) based on five subscale scores of erythema, pruritus, exudation, excoriation, and lichenification. The severity of each subscale was measured on a 4-point scale ranging from 0 (none) to 3 (severe), where higher scores indicating more severity. ADSI was calculated as the sum of these 5 subscale scores with a total possible score range of 0 (none) to 15 (most severe) where, higher scores indicating more severity. Improvement from Baseline was calculated as Baseline score minus follow-up score.|Baseline, Day 22|ITT population included all participants, who were randomized and received study drug.||units on a scale||Standard Deviation|Mean
678079|NCT01602341|Primary|Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 15|ADSI was used to assess the severity of atopic dermatitis (AD) based on five subscale scores of erythema, pruritus, exudation, excoriation, and lichenification. The severity of each subscale was measured on a 4-point scale ranging from 0 (none) to 3 (severe), where higher scores indicating more severity. ADSI was calculated as the sum of these 5 subscale scores with a total possible score range of 0 (none) to 15 (most severe) where, higher scores indicating more severity. Improvement from Baseline was calculated as Baseline score minus follow-up score.|Baseline, Day 15|ITT population included all participants who were randomized and received study drug.||units on a scale||Standard Deviation|Mean
678080|NCT01602341|Primary|Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 8|ADSI was used to assess the severity of atopic dermatitis (AD) based on five subscale scores of erythema, pruritus, exudation, excoriation, and lichenification. The severity of each subscale was measured on a 4-point scale ranging from 0 (none) to 3 (severe), where higher scores indicating more severity. ADSI was calculated as the sum of these 5 subscale scores with a total possible score range of 0 (none) to 15 (most severe) where, higher scores indicating more severity. Improvement from Baseline was calculated as Baseline score minus follow-up score.|Baseline, Day 8|ITT population included all participants who were randomized and received study drug.||units on a scale||Standard Deviation|Mean
678092|NCT01601821|Secondary|Incidence of Anemia|Diagnostic criterion for anemia was based on the laboratory results; in men: hemoglobin (Hb) <14 gram per deciliter (g/dL), hematocrit (Hct) <42%, or red blood cells (RBCs) <4.5 million/liter (million/L); for women: Hb <12 g/dL, Hct <37%, or RBC < 4 million/L. Percentage of participants with anaemia was reported.|Baseline up to Month 12|Analysis population included all participants enrolled in the study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||percentage of participants|||Number
678093|NCT01601821|Secondary|Percentage of Participants With Efficacy Failure or Premature Elimination|Efficacy failure was defined as the first occurrence of acute rejection, graft loss, or death. Premature elimination was defined as elimination from the study for any other reason.|Month 12|Analysis population included all participants enrolled in the study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||percentage of participants|||Number
678094|NCT01601821|Secondary|Incidence of Histologically Confirmed Lymphoproliferative Disease|Lymphoproliferative disorder represents an abnormal proliferation of B cells in response to either primary or reactivated infection with Epstein-Barr virus. Percentage of participants with histologically confirmed lymphoproliferative disease was reported.|Baseline up to Month 12|Analysis population included all participants enrolled in the study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||percentage of participants|||Number
678095|NCT01601821|Secondary|Incidence of Presumptive or Documented Infection|Presumptive or documented infection during the 12 months after transplantation; was confirmed by culture, biopsy, or serology and reported. Percentage of participants with presumptive or documented infection was reported.|Baseline up to Month 12|Analysis population included all participants enrolled in the study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||percentage of participants|||Number
678096|NCT01601821|Secondary|Percentage of Participants With Graft Survival|Graft survival defined as those participants who did not experience graft loss. Graft loss defined as physical loss (nephrectomy), functional loss (necessitating maintenance dialysis for >8 weeks), retransplant or death during the first 12 months after randomization.|Month 12|PP4 population included all participants who had completed study, also included those who dropped out of the study due to the occurrence of graft loss.||percentage of participants|||Number
678097|NCT01601821|Secondary|Percentage of Participants Who Survived|Survival defined as participants living with or without a functioning graft.|Month 12|PP3 population included all participants who had completed study, also included those who dropped out of the study due to the occurrence of death.||percentage of participants|||Number
678098|NCT01601821|Secondary|Histologic Grade of First Acute Rejection|Diagnosis of acute rejection was made via kidney biopsy. Categorization of biopsies with suspected acute rejection was based on histological findings using updated 1997 Banff criteria. Grade 1A: cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (5-10 cells/tubular cross section), Grade 1B: with severe tubulitis (>10 cells/tubular cross section), Grade 2A: mild-moderate intimal arteritis, Grade 2B: severe intimal arteritis and Grade 3: transmural arterits and/or fibrinoid necrosis. Data is reported as percentage of participants.|Baseline up to Month 12|PP2 population included all participants who had completed study, also included those who dropped out of the study due to biopsy confirmed acute rejection at Month 6. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||percentage of participants|||Number
678099|NCT01601821|Secondary|Incidence of Biopsy-Confirmed Acute Rejection|Diagnosis of acute rejection was made via kidney biopsy using Banff criteria. Percentage of participants with biopsy-confirmed acute rejection was reported.|Baseline up to Month 6|PP2 population included all participants who had completed study, also included those who dropped out of the study due to biopsy confirmed acute rejection at Month 6.||percentage of participants|||Number
678100|NCT01601821|Secondary|Glomerular Filtration Rate (GFR) by Nankivell Method|GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. GFR was calculated using the Nankivell formula. GFR by Nankivell equation= (6.7 per serum creatinine) plus (0.25*body weight) minus (0.5*serum urea) minus (100 per height square) plus (35 for male or 25 for female). A normal GFR is greater than (>)90 mL/min per 1.73 m^2 [mL/min/1.73 m^2], although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR less than (<)15 mL/min/1.73 m^2 indicated kidney failure.|Month 3, 6, 12|PP1 population. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' is number of participants evaluable at specific time points for each arm group.||mL/min/1.73 m^2||Standard Deviation|Mean
678101|NCT01601821|Secondary|Creatinine Clearance|Creatinine clearance (CCr) is a measure of kidney function. CCr is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 millimeters per minute (mL/min) and for females, 90-125 mL/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.|Month 3, 6, 12|PP1 population. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' is number of participants evaluable at specific time points for each arm group.||mL/min||Standard Deviation|Mean
678102|NCT01601821|Secondary|Serum Creatinine Level|Serum creatinine is an indicator of kidney function. Creatinine is a substance formed from the metabolism of creatine, commonly found in blood, urine and muscle tissue. It is removed from the blood by the kidneys and excreted in urine. An increased level of creatinine in the blood indicates decreased kidney function. Normal adult blood levels of creatinine are 0.5 to 1.1 milligram per deciliter (mg/dL) for females and 0.6 to 1.2 mg/dL for males; however, the normal values are age-dependent as elderly patients typically have smaller muscle mass.|Month 3, 6, 12|PP1 population. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' is number of participants evaluable at specific time points for each arm group.||mg/dL||Standard Deviation|Mean
678103|NCT01601821|Primary|Incidence of Efficacy Failure|Efficacy failure was defined as first occurrence of either biopsy confirmed acute rejection, graft loss or death within 12 months of post-transplantation. Percentage of participants with efficacy failure was reported.|Baseline up to Month 12|Per-protocol 1 (PP1) population included all participants who had completed study, also included those who dropped out of study due to occurrence of death, graft loss, or biopsy-confirmed acute rejection and had no major protocol deviations.||percentage of participants|||Number
678104|NCT01601782|Primary|Accuracy of 3D Ultrasound Scanning|5 to 10 minutes to complete a conventional ultrasound scan and up to 3 minutes to complete a volume imaging ultrasound scan. Both scans were done on the same day. For all scanned patients, the ultrasound technologist took a volume of images focusing where the patient had symptoms. The study PI reviewed the images, then went back in to do second scan. We found in every case that there was no value so we immediately scrapped the project.|Up to 13 minutes|||participants|||Number
678105|NCT01601782|Primary|Volume Imaging Assessment|"Determine if volume imaging can accurately diagnose muscle, bone and tendon injuries when compared to conventional x-ray scan.
The goal of the study is to determine if a diagnosis can be provided by reviewing a 3D data set of ultrasound images that are focused at a patient's site of maximal symptoms. The hypothesis was whether this simple technique using innovative 3D imaging could replace the more time-consuming manual scanning of a patient's extremity."|2 weeks||||||
678106|NCT01601704|Secondary|Percentage of Participants With a Confirmed Occurrence of Stroke (Nonfatal or Fatal)|Due to early termination of the study, the pre-planned 50% interim analysis is considered the primary analysis for outcome measures.|Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up|Intent-to-treat (ITT) population is defined as subjects who undergo randomization into the Treatment Period (TP) and are dispensed study medication. Treatment refers to the treatment assigned during TP randomization rather than the actual treatment received. ITT population is the primary analysis population for the primary and secondary endpoints.||Participants|||Count of Participants
678107|NCT01601704|Secondary|Percentage of Participants With a Confirmed Occurrence of Myocardial Infarction (Nonfatal or Fatal)|Due to early termination of the study, the pre-planned 50% interim analysis is considered the primary analysis for outcome measures.|Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up|Intent-to-treat (ITT) population is defined as subjects who undergo randomization into the Treatment Period (TP) and are dispensed study medication. Treatment refers to the treatment assigned during TP randomization rather than the actual treatment received. ITT population is the primary analysis population for the primary and secondary endpoints.||Participants|||Count of Participants
678108|NCT01601704|Secondary|Percentage of Participants With a Confirmed Occurrence of Cardiovascular Death (Including Fatal Myocardial Infarction, Fatal Stroke)|Due to early termination of the study, the pre-planned 50% interim analysis is considered the primary analysis for outcome measures.|Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up|Intent-to-treat (ITT) population is defined as subjects who undergo randomization into the Treatment Period (TP) and are dispensed study medication. Treatment refers to the treatment assigned during TP randomization rather than the actual treatment received. ITT population is the primary analysis population for the primary and secondary endpoints.||Participants|||Count of Participants
678109|NCT01601704|Secondary|Percentage of Participants With a Confirmed Occurrence of Cardiovascular Death, Nonfatal Myocardial Infarction, Nonfatal Stroke, or Nonfatal Unstable Angina Requiring Hospitalization|Due to early termination of the study, the pre-planned 50% interim analysis is considered the primary analysis for outcome measures.|Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up|Intent-to-treat (ITT) population is defined as subjects who undergo randomization into the Treatment Period (TP) and are dispensed study medication. Treatment refers to the treatment assigned during TP randomization rather than the actual treatment received. ITT population is the primary analysis population for the primary and secondary endpoints.||Participants|||Count of Participants
678110|NCT01601704|Primary|Percentage of Participants With a Confirmed Occurrence of Major Adverse Cardiovascular Event (MACE)|The primary endpoint is the time from randomization to the first confirmed occurrence of any event within the primary MACE composite (defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke). Due to early termination of the study, pre-planned 50% interim analysis is considered the primary analysis for outcome measures. The pre-planned 50% interim analysis was conducted when 50% of the total planned MACE were observed.|Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up|Intent-to-treat (ITT) population is defined as subjects who undergo randomization into the Treatment Period (TP) and are dispensed study medication. Treatment refers to the treatment assigned during TP randomization rather than the actual treatment received. ITT population is the primary analysis population for the primary and secondary endpoints.||Participants|||Count of Participants
678111|NCT01601691|Secondary|Rectum Radiation Dose|Rectum dose will be calculated based on CT scans after brachytherapy.|1 day, 4 weeks, 8 weeks||||||
678112|NCT01601691|Secondary|Side Effects|Possible side effects will be collected by subject interview and physical examination on specified time frame.|1 day, 4 weeks, 8 weeks, 12 weeks||||||
678113|NCT01601691|Primary|Spacer Volume Half Life|Time to spacer resolution will be measured based on the distance between rectum wall and prostate on CT scans before operation and on defined time frame. In addition, magnetic resonance imaging of pelvis will be performed 8 to 16 weeks after the operation in order to confirm the extent of spacer. Spacer volume half life is reported.|1 day, 4 weeks, 8 weeks, up-to 16 weeks|||days||Standard Deviation|Mean
678114|NCT01601470|Secondary|Adverse Events, Serious Adverse Events and Deaths Were Monitored From Screening to End of Study|Number of patients with adverse events, serious adverse events and death|From the screening visit until 30 days past the final study assessment|Safety Analysis Set: This set included participants who received at least one dose of study drug.||Participants|||Number
678115|NCT01601470|Primary|Time to Reach the Maximum Concentration After Drug Administration (Tmax) of Sildenafil and N-desmethyl-sildenafil Analytes|The effect of co-administration of LCZ696 on the pharmacokinetics of Sildenafil and N-desmethyl-sildenafil will be assessed. 8pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose from day 1 to day 7, 24 hours post-dose from day 7, day 8 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose. All time-points were used to mathematically derive the single PK parameter.|From pre-dose on day 1 until 12 hours post dose on day 8|PK Analysis Set (Period 3): This set included participants with evaluable PK data and without any protocol deviations which could impact the PK data.||hours||Full Range|Median
678192|NCT01600287|Primary|Percentage of Time Bispectral Index(BIS) Remains+/-10 of Target|The primary outcome to be measured is the ability of the system to keep the depth of anesthesia in the target range, i.e, Bispectral Index(BIS) value of 50+/- 10. This will assess the ability of the system to prevent intra-operative awareness of the patients and at the same time avoid excessive depth of anesthesia with its accompanying adverse effects.|Approximately 8 hours|||percentage of time||Standard Deviation|Mean
678116|NCT01601470|Primary|Maximum Plasma Concentration Following Drug Administration (Cmax) of Sildenafil and N-desmethyl-sildenafil Analytes|The effect of co-administration of LCZ696 on the pharmacokinetics of Sildenafil and N-desmethyl-sildenafil was assessed. Blood samples were collected at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose from day 1 to day 7, 24 hours post-dose from day 7, day 8 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose. All time-points were used to mathematically derive the single PK parameter.|From pre-dose on day 1 until 12 hours post dose on day 8|PK Analysis Set (Period 3): This set included participants with evaluable PK data and without any protocol deviations which could impact the PK data.||ng/mL||Standard Deviation|Mean
678117|NCT01601470|Primary|Terminal Elimination Half-life (T1/2) of Sildenafil and N-desmethyl-sildenafil Analytes|The effect of co-administration of LCZ696 on the pharmacokinetics of Sildenafil and N-desmethyl-sildenafil was assessed. Blood samples were collected at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose from day 1 to day 7, 24 hours post-dose from day 7, day 8 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose. T1/2 is a mathematically-derived value from all measurements. T1/2 is a measure of the area under the curve that is obtained from plotting the plasma concentration by time point. All time-points were used to derive the single PK parameters.|From pre-dose on day 1 until 12 hours post dose on day 8|PK Analysis Set (Period 3): This set included participants with evaluable PK data and without any protocol deviations which could impact the PK data.||hours||Standard Deviation|Mean
678118|NCT01601470|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Sildenafil and N-desmethyl-sildenafil Analytes|The effect of co-administration of LCZ696 on the pharmacokinetics of Sildenafil and N-desmethyl-sildenafil was assessed. Blood samples were collected at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose from day 1 to day 7, 24 hours post-dose from day 7, day 8 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose. AUC is a mathematically-derived value from all measurements. AUC is a measure of the area under the curve that is obtained from plotting the plasma concentration by time point. All time-points were used to derive the single PK parameters.|From pre-dose on day 1 until 12 hours post dose on day 8|PK Analysis Set (Period 3): This set included participants with evaluable PK data and without any protocol deviations which could impact the PK data.||h*ng/mL||Standard Deviation|Mean
678119|NCT01601470|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf) of Sildenafil and N-desmethyl-sildenafil Analytes|The effect of co-administration of LCZ696 on the pharmacokinetics of Sildenafil and N-desmethyl-sildenafil was assessed. Blood samples were collected at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose from day 1 to day 7, 24 hours post-dose from day 7, day 8 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose. AUC is a mathematically-derived value from all measurements. AUC is a measure of the area under the curve that is obtained from plotting the plasma concentration by time point. All time-points were used to derive the single PK parameters.|From pre-dose on day 1 until 12 hours post dose on day 8|PK Analysis Set (Period 3): This set included participants with evaluable PK data and without any protocol deviations which could impact the PK data.||h*ng/mL||Standard Deviation|Mean
678120|NCT01601470|Primary|Time to Reach the Maximum Concentration After Drug Administration (Tmax) of LCZ696 Analytes (AHU377, LBQ657 and Valsartan)|The effect of co-administration of sildenafil on the pharmacokinetics of LCZ696 (analytes of LCZ696: AHU377, LBQ657 and valsartan) was assessed. Blood samples were collected at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose from day 1 to day 7, 24 hours post-dose from day 7, day 8 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose. Tmax is a mathematically-derived value from all measurements. Tmax is a measure of the area under the curve that is obtained from plotting the plasma concentration by time point. All time-points were used to derive the single PK parameters.|From pre-dose on day 1 until 12 hours post dose on day 8|PK Analysis Set (Period 3): This set included participants with evaluable PK data and without any protocol deviations which could impact the PK data.||hours||Full Range|Median
678121|NCT01601470|Primary|Minimum Plasma Concentration Following Drug Administration at Steady State (Cmin,ss) of LCZ696 Analytes (AHU377, LBQ696 and Valsartan)|The effect of co-administration of sildenafil on the pharmacokinetics of LCZ696 (analytes of LCZ696: AHU377, LBQ657 and valsartan) was assessed. Blood samples were collected at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose from day 1 to day 7, 24 hours post-dose from day 7, day 8 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose. Cmin is a mathematically-derived value from all measurements. Cmin is a measure of the area under the curve that is obtained from plotting the plasma concentration by time point. All time-points were used to derive the single PK parameters.|From pre-dose on day 1 until 12 hours post dose on day 8|PK Analysis Set (Period 3): This set included participants with evaluable PK data and without any protocol deviations which could impact the PK data.||ng/mL||Standard Deviation|Mean
678122|NCT01601470|Primary|Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax,ss) of LCZ696 Analytes (AHU377, LBQ657 and Valsartan)|The effect of co-administration of sildenafil on the pharmacokinetics of LCZ696 (analytes of LCZ696: AHU377, LBQ657 and valsartan) was assessed. Blood samples were collected at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose from day 1 to day 7, 24 hours post-dose from day 7, and day 8 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose. Cmax is a mathematically-derived value from all measurements. Cmax is a measure of the area under the curve that is obtained from plotting the plasma concentration by time point. All time-points were used to derive the single PK parameters.|From pre-dose on day 1 until 12 hours post dose on day 8|PK Analysis Set (Period 3): This set included participants with evaluable PK data and without any protocol deviations which could impact the PK data.||ng/mL||Standard Deviation|Mean
678123|NCT01601470|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval (AUCtau) of LCZ696 Analytes|The effect of co-administration of sildenafil on the pharmacokinetics of LCZ696 (analytes of LCZ696: AHU377, LBQ657 and valsartan) was assessed. Blood samples were collected at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose from day 1 to day 7, 24 hours post-dose from day 7, and day 8 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose. AUC is a mathematically-derived value from all measurements. AUC is a measure of the area under the curve that is obtained from plotting the plasma concentration by time point. All time-points were used to derive the single PK parameters.|From pre-dose on day 1 until 12 hours post dose on day 8|PK Analysis Set (Period 3): This set included participants with evaluable PK data and without any protocol deviations which could impact the PK data.||h*ng/mL||Standard Deviation|Mean
678125|NCT01601236|Secondary|Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol|Percent change from baseline of serum total cholesterol, triglycerides, LDL, HDL, Lp(a), albumin, and cortisol|Visit 6, 9, 12, and 17|This trial had an adaptive design that pre-specified the closure of the 32 U arm (Group 5) in the event Acthar was not well tolerated at that dose. Based on tolerability, all patients initially included in the 32 U arm were combined with the 16 U arm (Group 3).||percent change||Standard Deviation|Mean
678126|NCT01601236|Secondary|Proportion of Subjects Whose Best Response Was Complete or Partial Remission of Proteinuria|Proportion of subjects whose best response was complete remission (PCR 0.5 g/g) or partial remission (reduction in PCR of >50% from baseline, plus PCR≤2.5 g/g but >0.5 g/g) of proteinuria|Visit 12 (Week 36) and Visit 17 (Week 52)|This trial had an adaptive design that pre-specified the closure of the 32 U arm (Group 5) in the event Acthar was not well tolerated at that dose. Based on tolerability, all patients initially included in the 32 U arm were combined with the 16 U arm (Group 3).||Participants|||Count of Participants
678127|NCT01601236|Secondary|Percent Change From Baseline in Protein to Creatinine Ratio (PCR)|Percent change from baseline in PCR|Visits 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and 17|This trial had an adaptive design that pre-specified the closure of the 32 U arm (Group 5) in the event Acthar was not well tolerated at that dose. Based on tolerability, all patients initially included in the 32 U arm were combined with the 16 U arm (Group 3).||percent change||Standard Error|Mean
678128|NCT01601236|Secondary|Percent Change From Baseline in eGFR by Visit|Percent change from baseline in eGFR by visit|Visit 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and 17|This trial had an adaptive design that pre-specified the closure of the 32 U arm (Group 5) in the event Acthar was not well tolerated at that dose. Based on tolerability, all patients initially included in the 32 U arm were combined with the 16 U arm (Group 3).||percent change||Standard Deviation|Mean
678129|NCT01601236|Secondary|Percent Change in eGFR Calculated Using Cystatin C|Percent change in eGFR calculated using cystatin C compared to baseline obtained at Visit 2.|Visit 12 (Week 36) and Visit 17 (Week 52)|This trial had an adaptive design that pre-specified the closure of the 32 U arm (Group 5) in the event Acthar was not well tolerated at that dose. Based on tolerability, all patients initially included in the 32 U arm were combined with the 16 U arm (Group 3).||percent change||Standard Deviation|Mean
678130|NCT01601236|Secondary|Complete or Partial Remission of Proteinuria|Proportion of patients with complete remission (PCR 0.5 g/g) or partial remission (reduction in PCR of >50% from baseline, plus PCR≤2.5 g/g but >0.5 g/g) of proteinuria at Visit 12 (Week 36) and/or at Visit 17 (Week 52)|Visit 12 (Week 36) and Visit 17 (Week 52)|This trial had an adaptive design that pre-specified the closure of the 32 U arm (Group 5) in the event Acthar was not well tolerated at that dose. Based on tolerability, all patients initially included in the 32 U arm were combined with the 16 U arm (Group 3).||Participants|||Count of Participants
678131|NCT01601236|Secondary|Time to Doubling of Serum Creatinine or ESRD or Death|The frequency doubling of serum creatinine or progression to ESRD or death was small therefore this parameter could not be analyzed.|Visit 12 (Week 36) or Visit 17 (Week 52)||||||
678132|NCT01601236|Secondary|Frequency of Patients With a Doubling of Serum Creatinine, Progression to End-stage Renal Disease (ESRD), or Death||Visit 12 (Week 36) and Visit 17 (Week 52)|This trial had an adaptive design that pre-specified the closure of the 32 U arm (Group 5) in the event Acthar was not well tolerated at that dose. Based on tolerability, all patients initially included in the 32 U arm were combined with the 16 U arm (Group 3).||Participants|||Count of Participants
678133|NCT01601236|Secondary|Percent Change in eGFR at Visit 17|Percent change in eGFR at Visit 17 (Week 52) compared to baseline eGFR obtained during screening|Visit 17 (Week 52)|This trial had an adaptive design that pre-specified the closure of the 32 U arm (Group 5) in the event Acthar was not well tolerated at that dose. Based on tolerability, all patients initially included in the 32 U arm were combined with the 16 U arm (Group 3).||percent change||Standard Error|Least Squares Mean
678134|NCT01601236|Primary|Percent Change in Estimated Glomerular Filtration Rate (eGFR) at Visit 12|Percent change in eGFR at Visit 12 (Week 36) compared to average baseline eGFR obtained during screening|Visit 12 (Week 36)|This trial had an adaptive design that pre-specified the closure of the 32 U (units) (Group 5) in the event Acthar was not well tolerated at that dose. Based on tolerability, all patients initially included in the 32 U arm were combined with the 16 U arm (Group 3).||percent change||Standard Error|Least Squares Mean
678135|NCT01601132|Primary|Apparent Total Volume of Distribution (Vd/F) of Theophylline|Apparent total volume of distribution after oral administration, calculated as Dose /(AUC0-∞) * Apparent first-order elimination rate constant [Kel])|Day 1 and Day 19 blood samples drawn pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours after dose administration.|PK population||liters||Standard Deviation|Mean
678136|NCT01601132|Primary|Apparent Total Body Clearance (CL/F) of Theophylline|Apparent total body clearance after oral administration, calculated as Dose /(AUC0-∞).|Day 1 and Day 19 blood samples drawn pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours after dose administration.|PK population||liters/hour||Standard Deviation|Mean
678137|NCT01601132|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. [AUC(0-∞)] was calculated as the sum of AUC (0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant for theophylline.|Day 1 and Day 19 blood samples drawn pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours after dose administration.|PK population||hours*μg/mL||Standard Deviation|Mean
678138|NCT01601132|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time of the Last Quantifiable Concentration[AUC(0-t)]|The area under the plasma concentration versus time curve from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule for theophylline.|Day 1 and Day 19 blood samples drawn pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours after dose administration.|PK population||hours*μg/mL||Standard Deviation|Mean
678164|NCT01600495|Secondary|Evaluation of TENS During the Active Phase of Labor Over the Use of Analgesia|Consider whether the TENS therapy during the active phase of labor could defer request for analgesia use for pain relief for pregnant women. The cervical dilation indicates the value in centimeters (0-10) of cervical dilation. Assessed on admission and during labor by doctors (according to the routine of the institution), as recorded in medical records.|10 hours|Analyzing the date of application of pharmacological analgesia.||cm||Standard Deviation|Mean
678139|NCT01601132|Primary|Maximum Plasma Concentration (Cmax) of Theophylline|The maximum or peak concentration of theophylline in the plasma, after a single dose on Day 1, and after another single dose on Day 19 following 14 days of colchicine dosing.|Day 1 and Day 19 blood samples drawn pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours after dose administration.|The pharmacokinetic (PK) population is defined as any participant who took a single dose of study medication and had sufficient blood sampling to characterize the non-compartmental PK parameters.||μg/mL||Standard Deviation|Mean
678140|NCT01601132|Primary|Time to Reach the Maximum Plasma Concentration (Tmax) of Theophylline|The time to each the maximum or peak concentration of theophylline in the plasma, after a single dose on Day 1, and after a single dose on Day 19, following 14 days of colchicine dosing.|Day 1 and Day 19 blood samples drawn pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours after dose administration.|The pharmacokinetic (PK) population is defined as any participant who took a single dose of study medication and had sufficient blood sampling to characterize the non-compartmental PK parameters. Patients with available data are included in the analysis.||hours||Full Range|Median
678141|NCT01600950|Secondary|Pharmacokinetics: Area Under the Concentration-time Curve (AUC) of LY2963016 and Lantus|AUC was not analyzed because of insufficient data due to concentrations being below the quantifiable lower limit of the assay.|Periods 1 and 2: Baseline up to 42 hours postdose|No participants were analyzed because of insufficient data.|||||
678142|NCT01600950|Secondary|Pharmacokinetics: Maximum Concentration (Cmax) of LY2963016 and Lantus|Cmax was not analyzed because of insufficient data due to concentrations being below the quantifiable lower limit of the assay.|Periods 1 and 2: Baseline up to 42 hours postdose|No participants were analyzed because of insufficient data.|||||
678143|NCT01600950|Secondary|Time of Maximum Glucose Infusion Rate (tRmax)|tRmax is the time to reach maximum glucose infusion rate and is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of study drug by adjusting the exogenous glucose infusion rate.|Periods 1 and 2: Baseline up to 42 hours postdose|All randomized participants who received the study drug during Periods 1 or 2. Participants were analyzed based on the treatment they received.||hours (hr)||Full Range|Median
678144|NCT01600950|Secondary|Total Glucose Infused (Gtot)|Gtot is the total glucose infusion over the clamp duration and is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of study drug by adjusting the exogenous glucose infusion rate. Data presented are the total glucose infused, adjusted by body weight.|Periods 1 and 2: Baseline up to 42 hours postdose|All randomized participants who received the study drug during Periods 1 or 2. Participants were analyzed based on the treatment they received.||milligrams/kilogram (mg/kg)||Geometric Coefficient of Variation|Geometric Mean
678145|NCT01600950|Secondary|Maximum Glucose Infusion Rate (Rmax)|Rmax is the maximum infusion rate of glucose administered intravenously needed to maintain a target blood glucose level of 100 milligrams/deciliter (mg/dL) [5.6 millimoles/Liter (mmol/L)] and is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of study drug by adjusting the exogenous glucose infusion rate. Data presented are the maximum infusion rates, adjusted by body weight.|Periods 1 and 2: Baseline up to 42 hours postdose|All randomized participants who received the study drug during Periods 1 or 2. Participants were analyzed based on the treatment they received.||milligrams/kilogram/minute (mg/kg/min)||Geometric Coefficient of Variation|Geometric Mean
678146|NCT01600950|Primary|Pharmacodynamics: Duration of Action of LY2963016 and Lantus|Duration of action is defined as the period of time elapsed between dose administration and the time at which the participant’s blood glucose is consistently >150 milligrams/deciliter (mg/dL) without any glucose infusion. Participants whose blood glucose did not rise to 150 mg/dL were censored 42 hours postdose.|Periods 1 and 2: Baseline up to 42 hours postdose|All randomized participants who received study drug during Periods 1 or 2. Participants were analyzed based on treatment they received. The numbers of participants censored were 7 for both LY2963016 and Lantus groups. Maximum duration of actions is based on participants who reached the end of action before 42 hours: 13 participants for both groups.||hours (hr)||Full Range|Median
678147|NCT01600885|Primary|Percent Change in Amelioration of Ketamine-related Task Activation as Measured by Functional Magnetic Resonance Imaging in Superior Frontal Gyrus|Difference Score: Percent Signal Change in Regions of Interest (ketamine - saline)|Within 4 hours of dose administration, after up to 1.25 hours of ketamine infusion|ALL SUBJECTS WHO COMPLETED THE STUDY WERE INCLUDED IN ANALYSIS||percent change in saline signal||Standard Error|Mean
678148|NCT01600885|Primary|Percent Change in Amelioration of Ketamine-related Task Activation as Measured by Functional Magnetic Resonance Imaging in Middle Frontal Gyrus|Difference Score: Percent Signal Change in Regions of Interest (ketamine - saline)|Within 4 hours of dose administration, after up to 1.25 hours of ketamine infusion|ALL SUBJECTS WHO COMPLETED THE STUDY WERE INCLUDED IN ANALYSIS||percent change in saline signal||Standard Error|Mean
678149|NCT01600885|Primary|Percent Change in Amelioration of Ketamine-related Task Activation as Measured by Functional Magnetic Resonance Imaging in Inferior Parietal Lobule|"Scans will be analyzed for task-related prefrontal activation
Difference Score: Percent Signal Change in Regions of Interest (ketamine - saline)"|Within 4 hours of dose administration, after up to 1.25 hours of ketamine infusion|ALL SUBJECTS WHO COMPLETED THE STUDY WERE INCLUDED IN ANALYSIS||percent change in saline signal||Standard Error|Mean
678165|NCT01600495|Primary|Classification of Pain During Labor by Visual Analogue Scale|"To evaluate the Transcutaneous Electrical Nerve Stimulation as a resource for pain relief during the active phase of labor will be used the Visual Analogue Scale.
Visual analogue scale (VAS): this scale, represented by a rule, the patient estimated pain on a scale of 100 mm (at one end labeled no pain associated with a score of 0 mm and at the other end worst pain imagined with a score 100 mm)"|30 minutes|We evaluated 46 patients, divided into 23 ENT group and 23 in the control group.||mm||Standard Deviation|Mean
678166|NCT01600482|Secondary|Device Success|Device Success (DS) is defined as the successful deployment of the Celt ACD device with the attainment of haemostasis and only assessed in the Celt ACD arm of the study.|30 days +/- 7 days|7 patients in the MP group did not have TTH recorded.||Number of patients|||Number
678150|NCT01600729|Primary|Intra-rater Reliability of Assessment of Facial Lines Using the 4-Point Facial Wrinkle Scale (FWS-A)|Intra-rater (within raters) agreement of the FWS-A scores (0=none; 1=mild; 2=moderate; 3=severe) was evaluated by weighted Kappa statistics (WKS). WKS were calculated for each of 7 raters who evaluated 65 participant's severity of facial lines in 4 areas (Glabellar Lines, Forehead Lines, Crow's Feet Lines on the Left side of the face and Crow's Feet Lines on the Right side of the face) at rest and maximum expression using the FWS-A scale at 2 different time-points on Day 1. The overall intra-rater agreement for WKS for all raters combined was estimated by pooling WKS for each rater using a chi-square statistic. The degree of agreement of the point estimates of WKS was interpreted according to the reference range scale that was predefined as: ≤0=poor, 0.00-0.20=slight, 0.21-0.40=fair, 0.41-0.60=moderate, 0.61-0.80=substantial and 0.81-1.00=almost perfect. The 95% confidence interval for WKS was provided.|Day 1|Participants from the Reliability population (all enrolled participants with at least 1 assessment by at least 1 live rater performed on day 1) who had 2 assessments on Day 1 available for analysis.||Kappa statistics||95% Confidence Interval|Mean
678151|NCT01600729|Primary|Inter-rater Reliability of Assessment of Facial Lines Using the 4-Point Facial Wrinkle Scale (FWS-A)|Inter-rater (among raters) agreement of the FWS-A scores (0= none; 1= mild; 2= moderate; 3= severe) was evaluated by Kappa statistics. Kappa statistics were calculated for each of 7 raters who evaluated 66 participant's severity of facial lines in 4 areas (Glabellar Lines, Forehead Lines, Crow's Feet Lines on the Left side of the face and Crow's Feet Lines on the Right side of the face) at rest and maximum expression using the FWS-A scale. The overall inter-rater agreement for Kappa statistics for all raters combined was estimated by pooling Kappa statistics for each rater using a chi-square statistic. The degree of agreement of the point estimates of Kappa statistics was interpreted according to the reference range scale that was predefined as: ≤ 0= poor, 0.00-0.20= slight, 0.21-0.40= fair, 0.41-0.60= moderate, 0.61-0.80= substantial and 0.81-1.00= almost perfect. The 95% confidence interval for Kappa statistics was provided.|Day 1|Reliability population included all enrolled participants with at least 1 assessment by at least 1 live rater performed on day 1.||Kappa statistics||95% Confidence Interval|Mean
678157|NCT01600703|Secondary|Apolipoprotein B100 Production Rate After Acute Oral Administration of 100mg Sitagliptin (Compared to Placebo)|Apolipoprotein B100 turnover was measured in a 10-hour kinetic study with in vivo tracer techniques and mathematical modeling to calculate production rates. Studies were performed under conditions of a pancreatic clamp and a steady state fed state in volunteers receiving single oral dose of either 100mg sitagliptin or matching placebo.|10 hours|||mg/kg/day||Standard Error|Mean
678158|NCT01600703|Primary|Apolipoprotein B48 Production Rate After Acute Oral Administration of 100mg Sitagliptin (Compared to Placebo)|Apolipoprotein B48 turnover was measured in a 10-hour kinetic study with in vivo tracer techniques and mathematical modeling to calculate production rates. Studies were performed under conditions of a pancreatic clamp and a steady state fed state in volunteers receiving single oral dose of either 100mg sitagliptin or matching placebo.|10 hours|||ug/kg/day||Standard Error|Mean
678159|NCT01600677|Secondary|Hospital Readmission Rates|Determine the percentage of patients that are readmitted to the hospital within 30 days of discharge|30 day|||% readmissions|||Number
678160|NCT01600677|Secondary|Medication-reconciliation Errors During Transition From Hospital to Home|Using the previously validated and reliable medication discrepancy tool (MDT)|90-day|||Participants with errors|||Number
678161|NCT01600677|Primary|Medication Adherence|Will be measured by: (number of doses/ doses scheduled; EMMA (intervention) vs. determined by manual monthly pill counts (control))|90-day|||percentage of medication adherence||Standard Deviation|Mean
678162|NCT01600495|Secondary|Number of Participants Who Were Satisfied With the Presence of a Professional/Physiotherapist During Labor.|Simple questionnaire (Questionnaire satisfaction of parturients with comparision with experience in this study) developed for this study with 3 items (yes, no and do not want to answer) to assess satisfaction of mothers in the intervention group and the control group regarding the presence of a professional during the period of study and experience in this work.|10 hours|All patients were invited to answer the questionnaire.||participants|||Number
678174|NCT01600326|Primary|Pain Level and Interference With Activity|"Patient symptoms are measured on a 50 point scale where 0 is no pain or interference with activities and 50 is highest pain and interference.
A verbal evaluation and assessment of subject's pain and symptoms will be completed prior to treatment. After receiving medication a second evaluation will be taken to determine how well the medication has relieved and controlled the subject's pain and inflammation associated with tendinitis.
Subjects will be specifically asked to rate the level of pain and how the pain is affecting common activities of daily living. The outcomes will be assessed at 2 follow up periods, 1 and approximately 2 weeks after treatment (but no more than 23 days)."|Up to 23 days|One data point is missing for time point one for Plasma Injection Group, as noted below.||units on a scale||Full Range|Mean
678175|NCT01600287|Other Pre-specified|Number of Times Rate of Propofol Changed Manually|Number of times rate of propofol needed to be changed manually|8 hours(aprrox)|||times per hour||Full Range|Median
678176|NCT01600287|Other Pre-specified|Total Off CPB Propofol Used (mg/kg/hr|total dosage of propofol used on per kg body weight per hour basis in the period before and after cardiopulmonary bypass period.|6 hours(approx)|||mg per kg body weight per hour||Standard Deviation|Mean
678177|NCT01600287|Other Pre-specified|Total Fentanyl Used (µg/kg)|total fentanyl used in the whole duration of surgery on per kg body weight basis|8 hours(approx)|||microgram per kg body weight||Standard Deviation|Mean
678178|NCT01600287|Other Pre-specified|Total Propofol Used (mg/kg/hr)|total propofol used based on per kg body weight per hour for the whole duration of surgery|8 hours (approx)|||mg per kg body weight per hour||Standard Deviation|Mean
678179|NCT01600287|Other Pre-specified|Percentage Fall in MAP During Induction|percentage fall in mean arterial pressure from baseline during induction|15 minutes|||percentage of fall from baseline||Standard Deviation|Mean
678180|NCT01600287|Other Pre-specified|Minimum BIS During Induction|Bispectral Index(BIS) is an EEG-based objective measure of anesthetic depth with values ranging from 100 to 0, lower number indicating greater depth of anesthesia. Values between 40 to 60 indicate adequate depth required for surgery. During induction of anesthesia, there is a tendency of overshooting the adequate depth of anesthesia, due to use of higher dose and rate of administration required for induction. The minimum BIS achieved during induction is a measure of this overshoot. The less the minimum value, the more is the overshoot, worse the outcome is. The minimum BIS during induction is automatically stored in the PC used for the study.|15 minutes|||Bispectral Index||Standard Deviation|Mean
678181|NCT01600287|Other Pre-specified|Induction Time|Time required for the first time achievement of two subsequent BIS values below or equal to 55|10 minutes|||seconds||Standard Deviation|Mean
678182|NCT01600287|Other Pre-specified|Induction Dose of Propofol|Dose of propofol needed for induction|10 minutes|||mg per kg body weight||Standard Deviation|Mean
678183|NCT01600287|Secondary|Intraoperative Phenylephrine Used (Pre CPB)|total phenylephrine dose needed to be used in the pre CPB period to maintain hemodynamic stability|2 hours(approx)|||microgram per Kg body weight||Standard Deviation|Mean
678184|NCT01600287|Secondary|Global Score|overall performance assessment of the system calculated as= [(MDAPE+Wobble)/percentage of time BIS remains within target]x100 Lower score indicates better overall performance|8 hours (approx)|||percentage of time||Standard Deviation|Mean
678185|NCT01600287|Secondary|Divergence|slope of the linear regression curve of performance error against time.|8 hours (approx)|||errors per second||Standard Deviation|Mean
678186|NCT01600287|Secondary|Intra-operative Awareness|The number of patients who will be able to recall the intra-operative events when assessed postoperatively. This will be assessed by a structured protocol|Approximately 3 days and then 1 month later|||participants|||Number
678187|NCT01600287|Secondary|Percentage of Time Mean Arterial Pressure Remains Within 25% of Pre-op Baseline|The duration of time mean arterial pressure remains within 25% of the pre-operative baseline value during the period propofol (general anesthetic) is administered to the study population. This value is expressed as percentage. This outcome is expressed as the mean of percentage of time per participant|Approximately 8 hours|||percentage of time||Standard Deviation|Mean
678188|NCT01600287|Secondary|Percentage of Time Heart Rate Remains Within 25% of Pre-op Baseline|The duration of time heart rate remains within 25% of the pre-operative baseline value during the period propofol (general anesthetic) is administered to the study population. This value is expressed as a percentage. This outcome is expressed as the mean of percentage of time per participant.|Approximately 8 hours|||percentage of time||Standard Deviation|Mean
678189|NCT01600287|Secondary|Wobble|Wobble measures the intra-individual variability in performance error.The median of the difference between individual performance errors throughout anesthesia and the median performance error for each participant is the wobble of that participant. The mean value per participant is indicated in the outcome measure.|Approximately 8 hours|||errors per participant||Standard Deviation|Mean
678190|NCT01600287|Secondary|Median Absolute Performance Error(MDAPE)|The difference between the observed and target of measure of depth of anesthesia (BIS) expressed as percentage of target BIS is calculated as performance error every 30 seconds. This value may be either '+' or '_' indicating whether the observed measure is above the target (overshoot-+) or below the target (undershoot-_).The median of the absolute values of performance errors (without considering the direction of error) is median absolute performance error. This outcome measures the magnitude of error or inaccuracy of the system studied. A lower value indicates a more precise system.This outcome is expressed as the mean of Median Absolute Performance Errors per participant.|Approximately 8 hours|||errors per participant||Standard Deviation|Mean
678191|NCT01600287|Secondary|Median Performance Error(MDPE)|The difference between the observed and target of measure of depth of anesthesia (BIS) expressed as percentage of target BIS is calculated as performance error every 30 seconds. This value may be either '+' or '_' indicating whether the observed measure is above the target (overshoot-+) or below the target (undershoot-_). The median value of all performance errors during propofol anesthesia is median performance error and is a measure of bias of the system. This outcome is expressed as the mean of Median Performance Errors per participant.|Approximately 8 hours|||errors per participant||Standard Deviation|Mean
678208|NCT01600222|Secondary|Number of Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 and 60 Minutes After ACTH-challenge at Day 28|Serum cortisol concentrations at 30 and 60 minutes after injection were measured in order to assess the maximum stimulated cortisol level achieved. Potential adrenal suppression was indicated if the serum cortisol concentration is ≤18mcg/dl at 30 minutes after the injection.|Day 28|||Subjects|||Number
678193|NCT01600222|Secondary|Efficacy Evaluation|The percentage of subjects who achieved ‘controlled disease’ (i.e., Clear or Almost clear) according to the Investigator’s Global Assessment (IGA) of disease severity on the trunk, limbs and scalp at Days 28 (Visit 3) and End of treatment (EoT) were presented.|4 weeks I 28 days and End of treatment|"The percentage of subjects achieving controlled disease on Day 28 (n=35) was calculated from the full analysis set.
The percentage of subjects achieving controlled disease at End of Treatment (n=37) was was calculated from the full analysis set using a last observation carried forward approach."||percentage of subjects|||Number
678194|NCT01600222|Secondary|Pharmacokinetic Evaluation T1/2|"The following PK parameters will be calculated, if possible, for each assayed compound based on the obtained plasma concentrations:
AUC0-t
AUC0-∞
Cmax
Tmax
T½
If it is not possible to calculate the above PK parameters, samples with plasma concentration above lower limit of quantification (LLOQ) will be presented."|4 weeks / 28 days|Plasma samples for PK assessment were collected from all 37 subjects however; PK samples from 2 subjects were only collected at screening (SV2) and at Day 14. Therefore these 2 subjects were excluded from PK analysis. Summary of PK parameters based on those subjects that had quantifiable plasma concentrations||h||Full Range|Mean
678195|NCT01600222|Secondary|Pharmacokinetic Evaluation Tmax|"The following PK parameters will be calculated, if possible, for each assayed compound based on the obtained plasma concentrations:
AUC0-t
AUC0-∞
Cmax
Tmax
T½
If it is not possible to calculate the above PK parameters, samples with plasma concentration above lower limit of quantification (LLOQ) will be presented.
All subjects but 1 had plasma concentration of calcipotriol below the LLOQ (lower limit of quantification), and thus it was not possible to calculate group mean of the derived PK parameter based on one sample. Provided values for calcipotriol Tmax are derived from that 1 subject."|4 weeks / 28 days|Plasma samples for PK assessment were collected from all 37 subjects however; PK samples from 2 subjects were only collected at screening (SV2) and at Day 14. Therefore these 2 subjects were excluded from PK analysis. Summary of PK parameters based on those subjects that had quantifiable plasma concentrations||h||Full Range|Median
678196|NCT01600222|Secondary|Pharmacokinetic Evaluation AUCinf|"The following PK parameters will be calculated, if possible, for each assayed compound based on the obtained plasma concentrations:
AUC0-t
AUC0-∞
Cmax
Tmax
T½
If it is not possible to calculate the above PK parameters, samples with plasma concentration above lower limit of quantification (LLOQ) will be presented."|4 weeks / 28 days|Plasma samples for PK assessment were collected from all 37 subjects however; PK samples from 2 subjects were only collected at screening (SV2) and at Day 14. Therefore these 2 subjects were excluded from PK analysis. Summary of PK parameters based on those subjects that had quantifiable plasma concentrations||pg/ml||Full Range|Mean
678197|NCT01600222|Secondary|Pharmacokinetic Evaluation AUClast|"The following PK parameters will be calculated, if possible, for each assayed compound based on the obtained plasma concentrations:
AUC0-t
AUC0-∞
Cmax
Tmax
T½
If it is not possible to calculate the above PK parameters, samples with plasma concentration above lower limit of quantification (LLOQ) will be presented.
All subjects but 1 had plasma concentration of calcipotriol below the LLOQ (lower limit of quantification), and thus it was not possible to calculate group mean of the derived PK parameter based on one sample. Provided values for calcipotriol AUClast are derived from that 1 subject."|4 weeks / 28 days|Plasma samples for PK assessment were collected from all 37 subjects however; PK samples from 2 subjects were only collected at screening (SV2) and at Day 14. Therefore these 2 subjects were excluded from PK analysis. Summary of PK parameters based on those subjects that had quantifiable plasma concentrations||pg/ml||Full Range|Mean
678198|NCT01600222|Secondary|Pharmacokinetic Evaluation Cmax|"The following PK parameters will be calculated, if possible, for each assayed compound based on the obtained plasma concentrations:
AUC0-t
AUC0-∞
Cmax
Tmax
T½
If it is not possible to calculate the above PK parameters, samples with plasma concentration above lower limit of quantification (LLOQ) will be presented.
All subjects but 1 had plasma concentration of calcipotriol below the LLOQ (lower limit of quantification), and thus it was not possible to calculate group mean of the derived PK parameter based on one sample. Provided values for calcipotriol Cmax are derived from that 1 subject."|4 weeks / 28 days|Plasma samples for PK assessment were collected from all 37 subjects however; PK samples from 2 subjects were only collected at screening (SV2) and at Day 14. Therefore these 2 subjects were excluded from PK analysis. Summary of PK parameters based on those subjects that had quantifiable plasma concentrations.||pg/ml||Full Range|Mean
678199|NCT01600222|Secondary|Number of Subjects Who Discontinued From the Study|Number of subjects who discontinued from the study due to adverse events.|Baseline to Day 28|||participants|||Number
678200|NCT01600222|Secondary|Change in Heart Rate From Baseline to Day 28|The effect of LEO 90100 on calcium metabolism was evaluated based on vital sign assessments (heart rate).|Baseline and Day 28|||beats/min||Standard Deviation|Mean
678201|NCT01600222|Secondary|Change in Blood Pressure From Baseline to Day 28|The effect of LEO 90100 on calcium metabolism was evaluated based on vital sign assessments (blood pressure).|Baseline and Day 28|||mmHg||Standard Deviation|Mean
678202|NCT01600222|Secondary|Change in Plasma Parathyroid Hormone (PTH) From Baseline to Day 28|The effect of LEO 90100 on calcium metabolism was evaluated based on change in plasma PTH from Baseline to Day 28.|Baseline and Day 28|||pmol/L||Standard Deviation|Mean
678203|NCT01600222|Secondary|Change in Serum Alkaline Phosphatase (ALP) From Baseline to Day 28|The effect of LEO 90100 on calcium metabolism was evaluated based on change in serum ALP from Baseline to Day 28.|Baseline and Day 28|||IU/L||Standard Deviation|Mean
678204|NCT01600222|Secondary|Change in Urinary Phosphate: Creatinine Ratio From Baseline to Day 28|The effect of LEO 90100 on calcium metabolism was evaluated based on change in urinary phosphate:creatinine ratio from Baseline to Day 28.|Baseline and Day 28|||mmol/g||Standard Deviation|Mean
678205|NCT01600222|Secondary|Change in 24-hour Urinary Phosphate Excretion From Baseline to Day 28|The effect of LEO 90100 on calcium metabolism was evaluated based on change in 24-hour urinary phosphate excretion from Baseline to Day 28.|Baseline and Day 28|||mmol/24H||Standard Deviation|Mean
678206|NCT01600222|Secondary|Change in Serum Phosphate From Baseline to Day 28|The effect of LEO 90100 on calcium metabolism was evaluated based on change in serum phosphate from Baseline to Day 28.|Baseline and Day 28|||mmol/L||Standard Deviation|Mean
678207|NCT01600222|Secondary|Number of Participants With an Adverse Drug Reaction (ADR)|Adverse drug reactions (ADRs) were defined as adverse events for which the investigator has not described the causal relationship to investigational medication as “not related”.|Baseline to Day 28|||participants|||Number
678212|NCT01600222|Primary|Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After Adrenocorticotrophic Hormone-challenge (ACTH-challenge)|HPA-axis testing by means of the rapid standard-dose cosyntropin test (ACTH-challenge test) for detection of adrenal suppression.|Day 28|Per protocol analysis set.||Subjects|||Number
678213|NCT01600092|Secondary|Percentage of Participants With >=3-fold Rise From Baseline in GMT of Serum Neutralizing Antibody to Human Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]||Baseline and 42 days after vaccination 3 (up to 185 days)|Participants who received the 3 scheduled doses of study vaccine, did not have important protocol deviations, and had baseline and follow-up results for the endpoint||Percentage of participants||95% Confidence Interval|Number
678214|NCT01600092|Secondary|Geometric Mean Titer of Serum Anti-Rotavirus Immunoglobulin A||42 days after vaccination 3 (up to 185 days)|Participants who received the 3 scheduled doses of study vaccine, did not have important protocol deviations, and had follow-up results for the endpoint||Titer||95% Confidence Interval|Geometric Mean
678215|NCT01600092|Secondary|Number of Participants With Tier-1 Adverse Events: Intussusception|The protocol-defined Tier-1 adverse event to be collected for the duration of the study (up to Day 185) was intussusception|Up to Day 185|Participants who received at least one dose of study vaccine. Participants were assigned to treatment groups based on the vaccine received as the first dose.||Participants|||Number
678216|NCT01600092|Secondary|Number of Participants With Tier-1 Adverse Events: Diarrhea, Vomiting, Elevated Temperature, and Irritability|An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse event. Protocol-defined Tier-1 adverse events to be collected up to 7 days after any vaccination were diarrhea, vomiting, elevated temperature (rectal >=38.1° C, >=100.5° F), and irritability.|Up to 7 days after any vaccination (up to 147 days)|Participants who received at least one dose of study vaccine. Participants were assigned to treatment groups based on the vaccine received as the first dose.||Participants|||Number
678217|NCT01600092|Primary|Geometric Mean Titer of Serum Neutralizing Antibody Response to Human Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]||42 days after vaccination 3 (up to 185 days)|Participants who received the 3 scheduled doses of study vaccine, did not have important protocol deviations, and had follow-up results for the endpoint||Titer||95% Confidence Interval|Geometric Mean
678218|NCT01600053|Secondary|Recording of the Occurrence of Adverse Events||From date of first dose until the date of first documented progression or date of death from any cause, whichever came first|This study has been terminated. Interim analysis showed that the trial will not meet the interim endpoint. Please see adverse event listing for additional information.||participants|||Number
678219|NCT01600053|Primary|Eradication of Residual Disease From the Marrow||From date of first dose until then end of 12 cycles of treatment (12 months) or progression of disease, whichever comes first.|This study has been terminated. Interim analysis showed that the trial will not meet the interim endpoint. Data were not collected from the 11 participants before study termination.|||||
678220|NCT01600014|Secondary|The Change in AK Count From Randomisation to 8 Weeks After Randomisation|The change in AK count from randomisation to 8 weeks after randomisation was determined for the field recalcitrant and the field recurrent subgroups|8 weeks after randomisation|||AK count||Standard Deviation|Mean
678221|NCT01600014|Secondary|Number of Participants With Complete Clearance Through to Month 12, Defined as no Clinically Visible AKs and no Lesions Treated in the Selected Treatment Area at Any Time From Last Treatment Cycle Through to Month 12|The analysis was done separately for the field recalcitrant subgroup, the field recurrent subgroup, and overall for all treated subject (Analysis 1, 2, and 3, respectively)|From last treatment cycle through to Month 12|||participants|||Number
678222|NCT01600014|Primary|Number of Participants With Complete Clearance of AKs 8 Weeks After Randomisation|The complete clearance rates 8 weeks after randomisation was compared between ingenol mebutate gel, 0.015% and vehicle gel. Complete clearance was defined as no clinically visible AKs in the Selected Treatment Area (STA)|8 weeks after randomisation|||participants|||Number
678223|NCT01599832|Other Pre-specified|Progression-free Survival|Specifically, whether baseline K^trans is associated with progression-free survival. Progression was assessed using Response Evaluation Criteria in Solid Tumors (Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum recorded since the treatment started OR the appearance of one or more new lesions OR unequivocal progression of existing non-target lesions)|2 years|Included those with a baseline K^trans value||weeks||Full Range|Median
678224|NCT01599832|Secondary|Changes in sVEGFR2 From Baseline to Post-treatment||Baseline and 1 week post-treatment|Data not collected|||||
678225|NCT01599832|Secondary|Changes in Blood Pressure From Baseline to Post-treatment||Baseline and 1 week post-treatment|Data were not collected|||||
678226|NCT01599832|Secondary|Change in K^Trans From Baseline|K^trans is a derived measure from dynamic contrast-enhanced magnetic resonance imaging that reflects perfusion rate and capillary permeability. The change is reported as the log-transformed ratio of K^trans value at follow-up/baseline.|Baseline and 1, 8, 16, and 24 weeks post-treatment|Included those with a baseline K^Trans value and at least 1 K^trans value at follow-up||unitless [log(ratio)]||Standard Deviation|Mean
678227|NCT01599832|Primary|Disease Progression|Specifically, whether the change in K^trans (the rise from nadir) as a time-dependent covariate, as assessed by the method described in Donner, is associated with disease progression.Progression was assessed using Response Evaluation Criteria in Solid Tumors (Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum recorded since the treatment started OR the appearance of one or more new lesions OR unequivocal progression of existing non-target lesions)|2 years|The accrued sample size of n=20 did not permit further assessment (as described in the Outcome Measure Description) of the primary endpoint, so simply reporting the median progression-free survival here||weeks||Full Range|Median
678228|NCT01599806|Secondary|Plasma Concentrations for Avibactam Between 300 to 360 Minutes After Dose(PK Analysis Set)|Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.|Between 300 to 360 minutes after dose|PK analysis set (avibactam between 300 to 360 minutes after dose)||NG/ML||Full Range|Geometric Mean
678229|NCT01599806|Secondary|Plasma Concentrations for Avibactam Between 30 to 90 Minutes After Dose(PK Analysis Set)|Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.|Between 30 to 90 minutes after dose|PK analysis set (avibactam between 30 to 90 minutes after dose)||NG/ML||Full Range|Geometric Mean
678230|NCT01599806|Secondary|Plasma Concentrations for Avibactam Within 15 Minutes Before/After Dose (PK Analysis Set)|Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.|within 15 minutes before/after dose|PK analysis set (avibactam within 15 minutes before/after dose)||NG/ML||Full Range|Geometric Mean
678231|NCT01599806|Secondary|Plasma Concentrations for Ceftazidime Between 300 to 360 Minutes After Dose(PK Analysis Set)|Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.|Between 300 to 360 minutes after dose|PK analysis set (ceftazidime between 300 to 360 minutes after dose)||NG/ML||Full Range|Geometric Mean
678232|NCT01599806|Secondary|Plasma Concentrations for Ceftazidime Between 30 to 90 Minutes After Dose(PK Analysis Set)|Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.|Between 30 to 90 minutes after dose|PK analysis set (ceftazidime between 30 to 90 minutes after dose)||NG/ML||Full Range|Geometric Mean
678233|NCT01599806|Secondary|Plasma Concentrations for Ceftazidime Within 15 Minutes Before/After Dose (PK Analysis Set)|Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.|within 15 minutes before/after dose|PK analysis set (ceftazidime within 15 minutes before/after dose)||NG/ML||Full Range|Geometric Mean
678234|NCT01599806|Secondary|Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)|Per pathogen microbiological response at TOC by Doripenem MIC for baseline pathogen in the ME at TOC analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization|Microbiological evaluable analysis set at TOC (ME at TOC)||Participant|||Number
678235|NCT01599806|Secondary|Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)|Per pathogen microbiological response at TOC by Doripenem MIC for baseline pathogen in the Extended ME at TOC analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization|Extended microbiological evaluable analysis set at TOC (EME at TOC)||Participant|||Number
678236|NCT01599806|Secondary|Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)|Per pathogen microbiological response at TOC by Doripenem MIC for baseline pathogen in the mMITT analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization|Microbiological modified intent to treat analysis set (mMITT)||Participant|||Number
678237|NCT01599806|Secondary|Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)|Per pathogen microbiological response at TOC by CAZ-AVI MIC for baseline pathogen in the ME at TOC analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization|Microbiological evaluable analysis set at TOC (ME at TOC)||Participant|||Number
678238|NCT01599806|Secondary|Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)|Per pathogen microbiological response at TOC by CAZ-AVI MIC for baseline pathogen in the Extended ME at TOC analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization|Extended microbiological evaluable analysis set at TOC (EME at TOC)||Participant|||Number
678239|NCT01599806|Secondary|Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)|Per pathogen microbiological response at TOC by CAZ-AVI MIC for baseline pathogen in the mMITT analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization|Microbiological modified intent to treat analysis set (mMITT)||Participant|||Number
678240|NCT01599806|Secondary|Per-pathogen Microbiological Response at LFU for Blood Only (ME at LFU Analysis Set)|Number of favorable per-pathogen microbiological responses at the LFU visit in the ME at LFU analysis set for blood only|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Microbiological evaluable analysis set at LFU (ME at LFU)||Participant|||Number
678241|NCT01599806|Secondary|Per-pathogen Microbiological Response at TOC for Blood Only (ME at TOC Analysis Set)|Number of favorable per-pathogen microbiological responses at the TOC visit in the ME at TOC analysis set for blood only|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological evaluable analysis set at TOC (ME at TOC)||Participant|||Number
678242|NCT01599806|Secondary|Per-pathogen Microbiological Response at EOT (IV) for Blood Only (ME at EOT (IV) Analysis Set)|Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the ME at EOT (IV) analysis set for blood only|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Microbiological evaluable analysis set at EOT (IV) (ME at EOT (IV))||Participant|||Number
678243|NCT01599806|Secondary|Per-pathogen Microbiological Response at LFU for Blood Only (Extended ME at LFU Analysis Set)|Number of favorable per-pathogen microbiological responses at the LFU visit in the Extended ME at LFU analysis set for blood only|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Extended microbiological evaluable analysis set at LFU (EME at LFU)||Participant|||Number
678244|NCT01599806|Secondary|Per-pathogen Microbiological Response at TOC for Blood Only (Extended ME at TOC Analysis Set)|Number of favorable per-pathogen microbiological responses at the TOC visit in the Extended ME at TOC analysis set for blood only|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Extended microbiological evaluable analysis set at TOC (EME at TOC)||Participant|||Number
678245|NCT01599806|Secondary|Per-pathogen Microbiological Response at EOT (IV) for Blood Only (Extended ME at EOT (IV) Analysis Set)|Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the Extended ME at EOT (IV) analysis set for blood only|At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Extended microbiological evaluable analysis set at EOT (IV) (EME at EOT (IV))||Participant|||Number
678246|NCT01599806|Secondary|Per-pathogen Microbiological Response at LFU for Blood Only (mMITT Analysis Set)|Number of favorable per-pathogen microbiological responses at the LFU visit in the mMITT analysis set for blood only|At LFU visit. LFU visit is 45 to 52 days from Randomization|Microbiological modified intent to treat analysis set (mMITT)||Participant|||Number
678247|NCT01599806|Secondary|Per-pathogen Microbiological Response at TOC for Blood Only (mMITT Analysis Set)|Number of favorable per-pathogen microbiological responses at the TOC visit in the mMITT analysis set for blood only|At TOC visit. TOC visit is 21 to 25 days from Randomization|Microbiological modified intent to treat analysis set (mMITT)||Participant|||Number
678248|NCT01599806|Secondary|Per-pathogen Microbiological Response at EOT (IV) for Blood Only (mMITT Analysis Set)|Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the mMITT analysis set for blood only|At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Microbiological modified intent to treat analysis set (mMITT)||Participant|||Number
678249|NCT01599806|Secondary|Per-pathogen Microbiological Response at LFU for Baseline Pathogen (ME at LFU Analysis Set)|Number of favorable per-pathogen microbiological responses at the LFU visit in the ME at LFU analysis set|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Microbiological evaluable analysis set at LFU (ME at LFU)||Participant|||Number
678250|NCT01599806|Secondary|Per-pathogen Microbiological Response at TOC for Baseline Pathogen (ME at TOC Analysis Set)|Number of favorable per-pathogen microbiological responses at the TOC visit in the ME at TOC analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological evaluable analysis set at TOC (ME at TOC)||Participant|||Number
678251|NCT01599806|Secondary|Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (ME at EOT (IV) Analysis Set)|Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the ME at EOT (IV) analysis set|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Microbiological evaluable analysis set at EOT (IV) (ME at EOT (IV))||Participant|||Number
678252|NCT01599806|Secondary|Per-pathogen Microbiological Response at LFU for Baseline Pathogen (Extended ME at LFU Analysis Set)|Number of favorable per-pathogen microbiological responses at the LFU visit in the Extended ME at LFU analysis set|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Extended microbiological evaluable analysis set at LFU (EME at LFU)||Participant|||Number
678253|NCT01599806|Secondary|Per-pathogen Microbiological Response at TOC for Baseline Pathogen (Extended ME at TOC Analysis Set)|Number of favorable per-pathogen microbiological responses at the TOC visit in the Extended ME at TOC analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Extended microbiological evaluable analysis set at TOC (EME at TOC)||Participant|||Number
678254|NCT01599806|Secondary|Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (Extended ME at EOT (IV) Analysis Set)|Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the Extended ME at EOT (IV) analysis set|At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Extended microbiological evaluable analysis set at EOT (IV) (EME at EOT (IV))||Participant|||Number
678255|NCT01599806|Secondary|Per-pathogen Microbiological Response at LFU for Baseline Pathogen (mMITT Analysis Set)|Number of favorable per-pathogen microbiological responses at the LFU visit in the mMITT analysis set|At LFU visit. LFU visit is 45 to 52 days from Randomization|Microbiological modified intent to treat analysis set (mMITT)||Participant|||Number
678256|NCT01599806|Secondary|Per-pathogen Microbiological Response at TOC for Baseline Pathogen (mMITT Analysis Set)|Number of favorable per-pathogen microbiological responses at the TOC visit in the mMITT analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization|Microbiological modified intent to treat analysis set (mMITT)||Participant|||Number
678257|NCT01599806|Secondary|Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (mMITT Analysis Set)|Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the mMITT analysis set|At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Microbiological modified intent to treat analysis set (mMITT)||Participant|||Number
678258|NCT01599806|Secondary|Time to First Defervescence While on IV Study Therapy (CE at TOC Analysis Set)|Time to first defervescence while on IV study therapy in patients in the CE at TOC analysis set who have fever at study entry.|Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.|Clinically evaluable analysis set at TOC(CE at TOC)||Participants|||Number
678259|NCT01599806|Secondary|Time to First Defervescence While on IV Study Therapy (Extended ME at TOC Analysis Set)|Time to first defervescence while on IV study therapy in patients in the Extended ME at TOC analysis set who have fever at study entry.|Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.|Extended microbiological evaluable analysis set at TOC(Extended ME at TOC)||Participants|||Number
678260|NCT01599806|Secondary|Time to First Defervescence While on IV Study Therapy (ME at TOC Analysis Set)|Time to first defervescence while on IV study therapy in patients in the ME at TOC analysis set who have fever at study entry.|Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.|Microbiological evaluable analysis set at TOC(ME at TOC)||Participants|||Number
678261|NCT01599806|Secondary|Time to First Defervescence While on IV Study Therapy (mMITT Analysis Set)|Time to first defervescence while on IV study therapy in patients in the mMITT analysis set who have fever at study entry.|Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.|Microbiological modified intent to treat analysis set (mMITT)||Participants|||Number
678262|NCT01599806|Secondary|Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set)|Favorable per-patient microbiological response at the TOC visit for patients infected with a ceftazidime resistant pathogen in the Extended ME at TOC analysis set.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Extended microbiological evaluable analysis set at TOC(Extended ME at TOC)||Participants|||Number
678263|NCT01599806|Secondary|Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set)|Favorable per-patient microbiological response at the TOC visit for patients infected with a ceftazidime resistant pathogen in the ME at TOC analysis set.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological evaluable analysis set at TOC(ME at TOC)||Participants|||Number
678314|NCT01599637|Secondary|Mean (SD) Serum Total IgE % Change From Baseline by Visit||Baseline through Day 85|All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis.||Percent Change from Baseline||Standard Deviation|Mean
678264|NCT01599806|Secondary|Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set)|Favorable per-patient microbiological response at the TOC visit for patients infected with a ceftazidime resistant pathogen in the mMITT analysis set.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological modified intent to treat analysis set (mMITT)||Participants|||Number
678265|NCT01599806|Secondary|Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set)|Clinical cure at the TOC visit for patients infected with a ceftazidime resistant pathogen in the Extended ME at TOC analysis set. Includes patients infected by at least one ceftazidime-resistant Gram-negative pathogen.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Extended microbiological evaluable analysis set at TOC(Extended ME at TOC)||Participants|||Number
678266|NCT01599806|Secondary|Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set)|Clinical cure at the TOC visit for patients infected with a ceftazidime resistant pathogen in the ME at TOC analysis set. Includes patients infected by at least one ceftazidime-resistant Gram-negative pathogen.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological evaluable analysis set at TOC(ME at TOC)||Participants|||Number
678267|NCT01599806|Secondary|Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set)|Clinical cure at the TOC visit for patients infected with a ceftazidime resistant pathogen in the mMITT analysis set. Includes patients infected by at least one ceftazidime-resistant Gram-negative pathogen.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological modified intent to treat analysis set (mMITT)||Participants|||Number
678268|NCT01599806|Secondary|Investigator Determined Clinical Response at LFU (CE at LFU Analysis Set)|Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Clinically evaluable analysis set at LFU (CE at LFU)||Participants|||Number
678269|NCT01599806|Secondary|Investigator Determined Clinical Response at TOC (CE at TOC Analysis Set)|Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Clinically evaluable analysis set at TOC (CE at TOC)||Participants|||Number
678270|NCT01599806|Secondary|Investigator Determined Clinical Response at EOT (IV) (CE at EOT (IV) Analysis Set)|Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Clinically evaluable analysis set at EOT (IV) (CE at EOT (IV))||Participants|||Number
678271|NCT01599806|Secondary|Investigator Determined Clinical Response at LFU (Extended ME at LFU Analysis Set)|Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Extended microbiological evaluable analysis set at LFU (Extended ME at LFU)||Participants|||Number
678272|NCT01599806|Secondary|Investigator Determined Clinical Response at TOC (Extended ME at TOC Analysis Set)|Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Extended microbiological evaluable analysis set at TOC (Extended ME at TOC)||Participants|||Number
678273|NCT01599806|Secondary|Investigator Determined Clinical Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set)|Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Extended microbiological evaluable analysis set at EOT (IV) (Extended ME at EOT (IV))||Participants|||Number
678274|NCT01599806|Secondary|Investigator Determined Clinical Response at LFU (ME at LFU Analysis Set)|Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Microbiological evaluable analysis set at LFU (ME at LFU)||Participants|||Number
678275|NCT01599806|Secondary|Investigator Determined Clinical Response at TOC (ME at TOC Analysis Set)|Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological evaluable analysis set at TOC (ME at TOC )||Participants|||Number
678276|NCT01599806|Secondary|Investigator Determined Clinical Response at EOT (IV) (ME at EOT (IV) Analysis Set)|Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Microbiological evaluable analysis set at EOT (IV) (ME at EOT (IV))||Participants|||Number
678277|NCT01599806|Secondary|Investigator Determined Clinical Response at LFU (mMITT Analysis Set)|Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Microbiological modified intent to treat analysis set (mMITT)||Participants|||Number
678278|NCT01599806|Secondary|Investigator Determined Clinical Response at TOC (mMITT Analysis Set)|Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological modified intent to treat analysis set (mMITT)||Participants|||Number
678279|NCT01599806|Secondary|Investigator Determined Clinical Response at EOT (IV) (mMITT Analysis Set)|Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Microbiological modified intent to treat analysis set (mMITT)||Participants|||Number
678280|NCT01599806|Secondary|Per-patient Microbiological Response at LFU (Extended ME at LFU Analysis Set)|Number of patients with a favorable per patient microbiological response at LFU|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Extended microbiological evaluable analysis set at LFU (Extended ME at LFU)||Participants|||Number
678281|NCT01599806|Secondary|Per-patient Microbiological Response at TOC (Extended ME at TOC Analysis Set)|Number of patients with a favorable per patient microbiological response at TOC|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Extended microbiological evaluable analysis set at TOC (Extended ME at TOC)||Participants|||Number
678282|NCT01599806|Secondary|Per-patient Microbiological Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set)|Number of patients with a favorable per-patient microbiological response at EOT (IV)|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Extended microbiological evaluable analysis set at EOT (IV) (EME at EOT (IV))||Participants|||Number
678283|NCT01599806|Secondary|Per-patient Microbiological Response at LFU (ME at LFU Analysis Set)|Number of patients with a favorable per patient microbiological response at LFU|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Microbiological evaluable analysis set at LFU (ME at LFU)||Participants|||Number
678284|NCT01599806|Secondary|Per-patient Microbiological Response at TOC (ME at TOC Analysis Set)|Number of patients with a favorable per patient microbiological response at TOC|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological evaluable analysis set at TOC (ME at TOC)||Participants|||Number
678285|NCT01599806|Secondary|Per-patient Microbiological Response at EOT (IV) (ME at EOT (IV) Analysis Set)|Number of patients with a favorable per-patient microbiological response at EOT (IV)|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Microbiological evaluable analysis set at EOT (IV) (ME at EOT (IV))||Participants|||Number
678286|NCT01599806|Secondary|Per-patient Microbiological Response at LFU (mMITT Analysis Set)|Number of patients with a favorable per patient microbiological response at LFU|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Microbiological modified intent to treat analysis set (mMITT)||Participants|||Number
678287|NCT01599806|Secondary|Per-patient Microbiological Response at EOT (IV) (mMITT Analysis Set)|Number of patients with a favorable per-patient microbiological response at EOT (IV)|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Microbiological modified intent to treat analysis set (mMITT)||Participants|||Number
678288|NCT01599806|Primary|Per-patient Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test|Number of patients with a favorable per patient microbiological response at TOC. The primary efficacy outcome variable for ROW is the proportion of patients with a favorable per-patient microbiological response at the TOC visit in the mMITT analysis set.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological modified intent to treat analysis set (mMITT)||Participants|||Number
678289|NCT01599806|Primary|Combined Patient-reported Symptomatic and Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test|Number of patients with both a favorable per patient microbiological response and symptomatic resolution (or return to premorbid state) of all UTI-specific symptoms (frequency/urgency/dysuria/suprapubic pain/flank pain) based on the patient-reported symptom assessment response at the TOC visit in the mMITT analysis set. The sponsor will conclude noninferiority if the lower limit of the 95% CI of difference (corresponding to a 97.5% 1-sided lower bound) is greater than -12.5% for both FDA coprimary outcome variables (symptomatic resolution at day 5 or favorable combined response at test of cure (TOC)).|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological modified intent to treat analysis set (mMITT)||Participants|||Number
678290|NCT01599806|Primary|Patient-reported Symptomatic Response at Day 5 (mMITT Analysis Set): Non-inferiority Hypothesis Test|Number of patients with symptomatic resolution (or return to premorbid state) of UTI-specific symptoms except flank pain (frequency/urgency/dysuria/suprapubic pain) with resolution of or improvement in flank pain based on the patient-reported symptom assessment response at the Day 5 visit in the mMITT analysis set. The sponsor will conclude noninferiority if the lower limit of the 95% CI of difference (corresponding to a 97.5% 1-sided lower bound) is greater than -12.5% for both FDA coprimary outcome variables (symptomatic resolution at day 5 or favorable combined response at test of cure (TOC)).|At Day 5 visit. Day 5 visit is based on 24 hour periods from the first dose date and time.|Microbiological modified intent to treat analysis set (mMITT)||Participants|||Number
678291|NCT01599741|Secondary|Radiation Dose Measurements: Air Kerma (AK)|"Percentage dose change of ClarityIQ vs. AlluraXper in AK calculated by AK/frame for DSA. Negative change means a reduction in dose for ClarityIQ vs. AlluraXper.
AK was measured during the ClarityIQ and AlluraXper runs during the procedure."|Participants were followed for the duration of the procedure|All patients with recorded dose information from the system for both DSA runs were used.||percentage of dose change||Standard Deviation|Mean
678292|NCT01599741|Secondary|Radiation Dose Measurements: Dose Area Product (DAP)|"Percentage dose change of ClarityIQ vs. AlluraXper in DAP calculated by DAP/frame for DSA. Negative change means a reduction in dose for ClarityIQ vs. AlluraXper.
DAP was measured during the ClarityIQ and AlluraXper runs during the procedure."|Participants were followed for the duration of the procedure|All patients with recorded dose information from the system for both DSA runs were used.||percentage of dose change||Standard Deviation|Mean
678293|NCT01599741|Primary|Image Quality|Overall proportion where diagnostic image quality of ClarityIQ is scored equal or better compared to AlluraXper by the blinded reviewers. Reading is performed by simultaneous visual comparison of image quality of AlluraXper and ClarityIQ by multiple blinded readers. All blinded readers have rated all side-by-side presented images. The images are presented in a random order and blinded to the reader. The hypothesis is that the overall proportion where diagnostic image quality of ClarityIQ is scored equal or better is ≥ than 0.80. Combined for all raters, the lower bound of the one-sided 95% CI (lower bound of the two-sided 90% CI) is used.|1 Day|All patients with recorded dose information from the system for both DSA runs were used.||Proportion of images rated equal/better||90% Confidence Interval|Mean
678294|NCT01599650|Secondary|BCVA (Letters) Mean Average Change From First Ranibizumab Treatment to Month 24 in the Study Eye for Patients Randomized to the Laser Monotherapy Arm|"Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)
-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. For the mean change of best corrected visual acuity at Month 24 compare to Baseline, the 95% confidence interval and P value (related to the null hypothesis that this mean change is equal to zero) based on a t distribution/t test were calculated and assessed by an ANOVA model."|Month 24|Randomized set||BCVA letters||Standard Deviation|Mean
678295|NCT01599650|Secondary|The Mean Change in Patient Reported Outcomes in NEI-VFQ-25 Score (Composite Score and Subscales) at Month 6 and Month 24 Compared to Baseline|The survey consists of 25 items representing 11 vision related constructs (general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision) plus a single-item general health rating question. All items are scored so that a high score represents better functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. In this format scores represent the achieved percentage of the total possible score, e.g. a score of 50 represents 50% of the highest possible score.|Months 6 and 24|||score on a scale||Standard Deviation|Mean
678296|NCT01599650|Secondary|The Mean Change in Central Reading Center-assessed Central Subfield Thickness From Month 12 and Month 24 vs. Baseline by Treatment Arm|Retinal thickness was measured using Optical Coherence Tomography (OCT). The images were reviewed by a central reading center to ensure a standardized evaluation. Stratification was done based on categories of baseline best corrected visual acuity & analysis was based on analysis of variance (ANOVA)|Month 12 and Month 24|||microns||Standard Error|Mean
678297|NCT01599650|Secondary|Number of Patients With a BCVA Improvement vs Baseline or Achieved Greater Than or Equal to 73 Letters at Month 24 in the Study Eye|Best Corrected Visual Acuity (BCVA) was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart at baseline and Month 12 while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. BCVA above 73 letters at Month 24 indicates a positive outcome.|Month 24|||participants|||Number
678298|NCT01599650|Secondary|Number of Patients With a BCVA Improvement vs Baseline or Achieving Greater Than or Equal to 73 Letters at Month 6 in the Study Eye|Best Corrected Visual Acuity (BCVA) was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart at baseline and Month 6 while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. BCVA above 73 letters at Month 6 indicates a positive outcome.|Month 6|||participants|||Number
678299|NCT01599650|Secondary|The Percent of Patients With a Visual Acuity Gain of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline up to Month 6 and Month 24, by Visit|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An increased score indicates improvement in acuity. This outcome assessed the number of participants who had improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 letters of visual acuity at Month 6 & Month 24 as compared with baseline, was assessed by an ANOVA model. Endpoints related to the proportion of patients with BCVA letter gain or loss from Baseline was analyzed via stratified Cochran-Mantel-Haenszel test with stratification based on baseline BCVA (baseline BCVA less than or equal to 39, 40 to 59, greater than or equal to 60 letters, treatment groups).|Baseline, Month 6 and Month 24|||percent patients gaining improvement|||Number
678300|NCT01599650|Secondary|The Mean Change in Visual Acuity BCVA (Letters) From Baseline at Month 12 and Month 24|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) -like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. For the mean change of best corrected visual acuity at Month 12 and Month 24 compare to Baseline, the 95% confidence interval and P value (related to the null hypothesis that this mean change is equal to zero) based on a t distribution/t test were calculated and were assessed by an ANOVA model.|Baseline, Month 12 and Month 24|Full Analysis set||letters||Standard Deviation|Mean
678301|NCT01599650|Secondary|Mean Average Change in Visual Acuity (BCVA Letters) From Month 1 Through Month 6|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) -like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters.(A positive average change from baseline of BCVA indicates improvement): Mean Average Change: for each patient, first average change is calculated as the average of the changes from baseline to Month 1 over Month 6. Then, mean average change is calculated as the average of average changes across all patients.|From Baseline through Month 6|||letters||Standard Deviation|Mean
678302|NCT01599650|Secondary|Number of Ranibizumab Treatments From Day 1 to Month 23 by Treatment Group|Number of injections provided to the patients during the 23 month period and conducted within FAS with LOCF and observed data.|Day 1 through Month 23|||treatments||Standard Deviation|Mean
678315|NCT01599637|Secondary|Mean (SD) Serum Total IgE Concentration From Baseline by Visit||Baseline through Day 85|All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis.||ng/mL||Standard Deviation|Mean
678303|NCT01599650|Secondary|The Mean Average Change in Visual Acuity From Month 1 Through Month 24 Compared to Baseline|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. (A positive average change from baseline of BCVA indicates improvement): Mean Average Change: for each patient, first average change is calculated as the average of the changes from baseline to Month 1 over Month 24. Then, mean average change is calculated as the average of average changes across all patients.|Baseline, 24 Months|analysis for change consists of the group that had a baseline and 24 month data point||letters||Standard Deviation|Mean
678304|NCT01599650|Primary|Mean Change in Visual Acuity: BCVA Change at Month 6 Compared to Baseline in Patients With Visual Impairment Due to Branch Retinal Vein Occlusion (BRVO)|"Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)
-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. For the mean change of best corrected visual acuity at Month 6 compare to Baseline, the 95% confidence interval and P value (related to the null hypothesis that this mean change is equal to zero) based on a t distribution/t test were calculated and assessed by an ANOVA model."|Baseline, 6 Months|analysis for change consists of the group that had a baseline and 6 month data point||letters||Standard Deviation|Mean
678305|NCT01599637|Secondary|Chronic Urticaria Quality of Life Questionnaire (Cu-Q2OL) by Treatment|The Cu-Q2OL is a 23-item CIU-specific health-related quality of life questionnaire. Patients rated their CIU symptoms and the impact of their CIU on various aspects of their lives. An overall score was calculated as well for the following domains: pruritus, swelling, impact on life activities, sleep problems, limits, and looks. Zero is the minmum score and 100 the maximum score. The higher score correlates to more disease activity.|Baseline and Day 85|Efficacy analysis set which included all randomized patients who received at least one dose of study drug and had post-randomization efficacy data||score||Standard Deviation|Mean
678306|NCT01599637|Secondary|Skindex-29 by Treatment|The Skindex-29 is a validated 29-item instrument to measure the effects of skin disease on patients’ quality of life.Results are reported as 3 scale scores (functioning, emotions and symptoms) and a composite score (average scale score). The domain scores and the overall score are expressed on a 100-point scale, with higher scores indicating a lower level of quality of life. The cuttoff values for each category are noted below. Symtoms; 39 mild, 42 moderate,52 severe. Emotions; 24 mild, 35 moderate, 39 severe. Functioning: 21 mild, 32 moderate, 37 severe. Overal Score: 25 mild, 32 moderate, 44 severe.|Baseline and Day 85|Efficacy analysis set which included all randomized patients who received at least one dose of study drug and had post-randomization efficacy data||Score||Standard Deviation|Mean
678307|NCT01599637|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) by Treatment|The DLQI is a 10-item dermatology-specific health-related quality of life measure. Patients rated their dermatology symptoms as well as the impact of their skin condition on various aspects of their lives. An overall score was calculated as well as for the following domains: Symptoms and Feelings, Daily Activities, Leisure, Work and School, Personal Relationships, Treatment.Negative score shows positive efficacy. Meaning of DLQI Scores 0-1 = no effect at all on patient's life 2-5 = small effect on patient's life 6-10 = moderate effect on patient's life 11-20 = very large effect on patient's life 21-30 = extremely large effect on patient's life. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. The DLQI can also be expressed as a percentage of the maximum possible score of 30.|Baseline through Day 85|Efficacy analysis set which included all randomized patients who received at least one dose of study drug and had post-randomization efficacy data||Score||Standard Deviation|Mean
678308|NCT01599637|Secondary|Percentage of Angioedema-free Days Weeks 4 Through 12 by Treatment||Day 29 to Day 85|Efficacy analysis set which included all randomized patients who received at least one dose of study drug and had post-randomization efficacy data||Percentage of days||Standard Deviation|Mean
678309|NCT01599637|Secondary|Likert Scale-Physician’s and Patients In-clinic Global Assessment by Treatment|The investigator or the person he or she designated and the patient provided scoring of the patient’s global assessment of symptoms (urticaria lesions (hives) and pruritus) reflective of the patient’s condition over the 12 hours prior to the visit (0 = no symptoms, 1 = mild, 2 = moderate 3 = severe|Baseline, Day 85|Efficacy analysis set which included all randomized patients who received at least one dose of study drug and had post-randomization efficacy data||score||Standard Deviation|Mean
678310|NCT01599637|Secondary|Change From Baseline in Urticaria Activity Score (UAS7)|Efficacy was assessed by the urticaria activity score (UAS). UAS was completed each morning and evening on a daily basis to record patient symptoms of itch and hives via an electronic diary. The UAS is a composite eDiary−recorded score with numeric severity intensity ratings on a scale of 0−3 (0 = none to 3 = intense/severe) for 1) the number of wheals (hives); and 2) the intensity of the itch. The daily UAS is the average of the morning and evening scores and the UAS7 is the sum of the daily UAS scores over 7 days.UAS7 score: The sum of the daily UAS scores over 7 days. Range: 0-42. If fewer than 7 but at least 4 daily values were non-missing, the remaining values were imputed to be the average. This is equivalent to multiplying the average of the non missing values by 7. UAS7 score: The sum of the daily UAS scores over 7 days. Range: 0-42. A higher score indicates worse disease. A negative change score (Week 12 score minus Baseline score) indicates improvement.|Baseline, Day 85|Efficacy analysis set which included all randomized patients who received at least one dose of study drug and had post-randomization efficacy data. If the Week 12 value was missing, it was imputed as the last available UAS7 value (LOCF).||units on a scale||Standard Deviation|Mean
678311|NCT01599637|Secondary|Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit||Baseline through Day 140|All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis.||IU/mL||Standard Deviation|Mean
678312|NCT01599637|Secondary|Mean (SD) Serum Free IgE % Change From Baseline by Visit||Baseline through Day 85|All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis.||% change||Standard Deviation|Mean
678313|NCT01599637|Secondary|Mean (SD) Serum Free IgE Concentration From Baseline by Visit||Baseline through Day 85|All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis.||ng/mL||Standard Deviation|Mean
678316|NCT01599637|Secondary|Serum Levels of Omalizumab|Serum concentrations (ng/mL) of omalizumab by visit after the administration of omalizumab 300 mg every 4 weeks|Baseline through Day 85|PK analysis set which included all subjects who received at least one dose of study drug and had evaluable IGE025 concentrations.||ng/mL||Standard Deviation|Mean
678317|NCT01599637|Secondary|Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set|The # positive cell values are average of cell numbers derived from counting 5 consecutive microscopic fields. Area counted is 5x 0.196 mm2|Baseline|All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis||# positive cells||Standard Deviation|Mean
678318|NCT01599637|Secondary|Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured in Fluorescence Units.|Fluorescence-activated cell sorting (FACS) is a specialized type of flow cytometry that provides a method for sorting a heterogeneous mixture of biological cells into two or more containers, one cell at a time, based upon the specific light scattering and fluorescent characteristics of each cell. (FACS) provides fast, objective and quantitative recording of fluorescent signals from individual cells as well as physical separation of cells of particular interest. A wide range of fluorophores can be used as labels in flow cytometry. Fluorophores are typically attached to an antibody that recognizes a target feature on or in the cell; they may also be attached to a chemical entity with affinity for the cell membrane or another cellular structure. Each fluorophore has a characteristic peak excitation and emission wavelength.|Baseline through Day 85|All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis.• FACS parameters: FceRI expression on basophils and IgE bound, FceR2 expression on B cells and IgE bound, and FceRI expression on dendritic cells||Flourescence units||Standard Deviation|Mean
678319|NCT01599637|Secondary|Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured as % Out of Leukocytes.|Fluorescence-activated cell sorting (FACS) is a specialized type of flow cytometry that provides a method for sorting a heterogeneous mixture of biological cells into two or more containers, one cell at a time, based upon the specific light scattering and fluorescent characteristics of each cell. (FACS) provides fast, objective and quantitative recording of fluorescent signals from individual cells as well as physical separation of cells of particular interest. A wide range of fluorophores can be used as labels in flow cytometry. Fluorophores are typically attached to an antibody that recognizes a target feature on or in the cell; they may also be attached to a chemical entity with affinity for the cell membrane or another cellular structure. Each fluorophore has a characteristic peak excitation and emission wavelength.|Baseline through Day 85|All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis.||% out of leukocytes||Standard Deviation|Mean
678320|NCT01599637|Secondary|Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit||Baseline through Day 85|All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis.||ug/mL||Standard Deviation|Mean
678321|NCT01599637|Secondary|Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit|The average number of cells derived from counting 5 consecutive microscopic fields. Area counted is 5x 0.196 mm2|Baseline to Day 85|All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis. Day 29 was an optional sampling time point in this paramter. The values are average of cell numbers derived from counting 5 consecutive microscopic fields. Area counted is 5x 0.196 mm2||# positive cells||Standard Deviation|Mean
678322|NCT01599637|Secondary|Correlation of Change From Baseline in IgE on Positive Skin Cells With Change From Baseline in UAS7 at Week 12 by Treatment, Skin Layer and Lesion Status|Correlation of primary endpoint with The UAS7 which is a composite eDiary−recorded score with numeric severity intensity ratings on a scale of 0−3 (0 = none to 3 = intense/severe) for 1) the number of wheals (hives); and 2) the intensity of the itch. The daily UAS is the average of the morning and evening scores and the UAS7 is the sum of the daily UAS scores over 7 days.UAS7 score: The sum of the daily UAS scores over 7 days. Range: 0-42. If fewer than 7 but at least 4 daily values were non-missing, the remaining values were imputed to be the average. This is equivalent to multiplying the average of the non missing values by 7. UAS7 score: The sum of the daily UAS scores over 7 days. Range: 0-42. A higher score indicates worse disease.|Baseline through Day 85|Efficacy analysis set: Includes all randomized patients who received at least one dose of study drug and have post-randomization efficacy data.||correlation coefficient|||Number
678323|NCT01599637|Secondary|Correlation of Change From Baseline in IgE Receptor FceRI With Change From Baseline in UAS7 at Week 12 by Treatment, Skin Layer and Lesion Status|Correlation of primary endpoint with The UAS7 which is a composite eDiary−recorded score with numeric severity intensity ratings on a scale of 0−3 (0 = none to 3 = intense/severe) for 1) the number of wheals (hives); and 2) the intensity of the itch. The daily UAS is the average of the morning and evening scores and the UAS7 is the sum of the daily UAS scores over 7 days.UAS7 score: The sum of the daily UAS scores over 7 days. Range: 0-42. If fewer than 7 but at least 4 daily values were non-missing, the remaining values were imputed to be the average. This is equivalent to multiplying the average of the non missing values by 7. UAS7 score: The sum of the daily UAS scores over 7 days. Range: 0-42. A higher score indicates worse disease.|Baseline through Day 85|Efficacy analysis set: Includes all randomized patients who received at least one dose of study drug and have post-randomization efficacy data.||correlation coefficient|||Number
678324|NCT01599637|Primary|Observed Values and Absolute Change From Baseline in IgE Positive Skin Cells: Dermis, Lesional and Non Lesional Skin|Observed values and absolute change in IgE positive skin cells: dermis non-lesional and lesional The primary variable for this study was the relative change from baseline in IgE positive skin cells, based on skin biopsies collected from patients with CIU after 12 weeks of treatment. The values are average of cell numbers derived from counting 5 consecutive microscopic fields. Area counted is 5x 0.196 mm2|Baseline through Day 85 post-treatment|All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis. Patients with both baseline and week 12 data were included in this analysis||IgE positive skin cells||Standard Deviation|Mean
678325|NCT01599637|Primary|Observed Values and Absolute Change From Baseline in FceRI Positive Skin Cells: Dermis, Lesional and Non Lesional Skin|Observed values and absolute change in FcεRI positive skin cells: dermis non-lesional and lesional. The primary variable for this study was the relative change from baseline in the high affinity IgE receptor (FcεRI) positive skin cells, based on skin biopsies collected from patients with CIU after 12 weeks of treatment.The values are average of cell numbers derived from counting 5 consecutive microscopic fields. Area counted is 5x 0.196 mm2|Baseline through Day 85 post-treatment|All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis. Patients with both baseline and week 12 data were included in this analysis||FcεRI positive skin cells||Standard Deviation|Mean
678326|NCT01599585|Secondary|Beck Hopelessness Scale (BHS)|The BHS is a 20-item scale for measuring negative attitudes about the future. Each item is scored with a true/false response. Total scores range from 0-20 with higher scores indicating a greater degree of hopelessness.|3 month follow up|||units on a scale||Standard Deviation|Mean
678327|NCT01599585|Secondary|Beck Hopelessness Scale (BHS)|The BHS is a 20-item scale for measuring negative attitudes about the future. Each item is scored with a true/false response. Total scores range from 0-20 with higher scores indicating a greater degree of hopelessness.|Midpoint- Week 4|||units on a scale||Standard Deviation|Mean
678328|NCT01599585|Secondary|Beck Hopelessness Scale (BHS)|The BHS is a 20-item scale for measuring negative attitudes about the future. Each item is scored with a true/false response. Total scores range from 0-20 with higher scores indicating a greater degree of hopelessness.|Baseline|||units on a scale||Standard Deviation|Mean
678329|NCT01599585|Secondary|Beck Depression Inventory -II (BDI-II)|The BDI-II is the most commonly used self-report measure of clinical depression severity. It consists of 21 items that are rated on a 4-point scale which yield a range of scores from 0 - 63. The BDI-II has sound psychometric properties. The higher the score the worse the outcome.|3 month follow up|||units on a scale||Standard Deviation|Mean
678330|NCT01599585|Secondary|Beck Depression Inventory -II (BDI-II)|The BDI-II is the most commonly used self-report measure of clinical depression severity. It consists of 21 items that are rated on a 4-point scale which yield a range of scores from 0 - 63. The BDI-II has sound psychometric properties. The higher the score the worse the outcome.|Post Treatment- Week 8|||units on a scale||Standard Deviation|Mean
678331|NCT01599585|Secondary|Beck Depression Inventory -II (BDI-II)|The BDI-II is the most commonly used self-report measure of clinical depression severity. It consists of 21 items that are rated on a 4-point scale which yield a range of scores from 0 - 63. The BDI-II has sound psychometric properties. The higher the score the worse the outcome|Midpoint- Week 4|||units on a scale||Standard Deviation|Mean
678332|NCT01599585|Secondary|Adverse Events|Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.|3 month follow up|Adverse event data is recorded in adverse event section||participants|||Number
678333|NCT01599585|Secondary|Adverse Events|Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.|Treatment Session Week 8|Adverse event data recorded in adverse event section||participants|||Number
678334|NCT01599585|Secondary|Adverse Events|Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.|Treatment Session Week 7|adverse events are reported in adverse event section||participants|||Number
678335|NCT01599585|Secondary|Adverse Events|Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.|Treatment Session Week 6|adverse events are reported in the adverse event section||participants|||Number
678336|NCT01599585|Secondary|Adverse Events|Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.|Treatment Session Week 5|adverse events are reported in adverse event section||participants|||Number
678337|NCT01599585|Secondary|Adverse Events|Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.|Treatment Session Week 4|Adverse Event data recorded in Adverse event section||participants|||Number
678338|NCT01599585|Secondary|Adverse Events|Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.|Treatment Session Week 3|adverse event data reported in adverse event section||participants|||Number
678410|NCT01598428|Secondary|Refractive Error|auto refraction was performed at each visit. Spherical equivalent refraction (SER) (sphere +cylinder/2) was used in subsequent calculations.|1 day，1 week, 1 month as well as 3 months and 6 months postoperatively|||diopter(D)|Participants|Standard Deviation|Mean
678339|NCT01599585|Secondary|Adverse Events|Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.|Treatment Session Week 2|adverse event data reported in adverse event section||participants|||Number
678340|NCT01599585|Secondary|Beck Depression Inventory -II (BDI-II)|The BDI-II is the most commonly used self-report measure of clinical depression severity. It consists of 21 items that are rated on a 4-point scale which yield a range of scores from 0 – 63. The BDI-II has sound psychometric properties. The higher the score the worse the outcome.|Baseline|||units on a scale||Standard Deviation|Mean
678341|NCT01599585|Secondary|Adverse Events|Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.|Treatment Session Week 1|AE data reported in adverse events section||participants|||Number
678342|NCT01599585|Primary|Beck Hopelessness Scale (BHS)|The BHS is a 20-item scale for measuring negative attitudes about the future. Each item is scored with a true/false response. Total scores range from 0-20 with higher scores indicating a greater degree of hopelessness.|Post treatment - Week 8|||units on a scale||Standard Deviation|Mean
678343|NCT01599325|Secondary|Apparent Volume of Distribution (Vd/F) of Azacitidine|Apparent volume of distribution, was calculated according to the equation: Vd/F = (CL/F)/λz|PK blood samples collected at 0.25, 0.5, 1,2,3,4, 6 and 8 hours after azacitidine administration on Day 7|The PK population includes up to 12 participants with evaluable azacitidine plasma PK profile.||Liters||Geometric Coefficient of Variation|Geometric Mean
678344|NCT01599325|Secondary|Apparent Total Plasma Clearance (CL/F) of Azacitidine|Apparent total plasma clearance (CL/F) of Azacitidine was calculated as Dose/AUC∞|PK blood samples collected at 0.25, 0.5, 1,2,3,4, 6 and 8 hours after azacitidine administration on Day 7|The PK population includes up to 12 participants with evaluable azacitidine plasma PK profile.||Liters/hours||Geometric Coefficient of Variation|Geometric Mean
678345|NCT01599325|Secondary|Terminal Phase of Half-life (T1/2) of Azacitidine|The apparent terminal half-life was calculated according to the following equation t½ = 0.693/λz.|PK blood samples collected at 0.25, 0.5, 1,2,3,4, 6 and 8 hours after azacitidine administration on Day 7|The PK population includes up to 12 participants with evaluable azacitidine plasma PK profile.||hours||Geometric Coefficient of Variation|Geometric Mean
678346|NCT01599325|Secondary|Time to Maximum Plasma Concentration (Tmax) of Azacitidine|Time to maximum observed plasma concentration obtained directly from the observed concentration versus time data.|PK blood samples collected at 0.25, 0.5, 1,2,3,4, 6 and 8 hours after azacitidine administration on Day 7|The PK population includes up to 12 participants with evaluable azacitidine plasma PK profile.||hours||Full Range|Median
678347|NCT01599325|Secondary|Maximum Observed Plasma Concentration (Cmax) of Azacitidine|The observed maximum plasma concentration obtained directly from the observed concentration versus time data.|PK blood samples collected at 0.25, 0.5, 1,2,3,4, 6 and 8 hours after azacitidine administration on Day 7|The PK population includes up to 12 participants with evaluable azacitidine plasma PK profile.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
678348|NCT01599325|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUCt) of Azacitidine|Area under the plasma concentration-time curve from time zero to the last quantifiable time point, calculated by the linear trapezoidal rule when concentrations are increasing and the logarithmic trapezoidal method when concentrations are decreasing.|PK blood samples collected at 0.25, 0.5, 1,2,3,4, 6 and 8 hours after azacitidine administration on Day 7|The PK population includes up to 12 participants with evaluable azacitidine plasma PK profile.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
678349|NCT01599325|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC∞) of Azacitidine|Area under the plasma concentration-time curve from time zero to infinity (AUC∞) following multiple doses of Azacitidine on Day 7; if possible, the area under the concentration-time curve from time zero to infinity, calculated by the linear trapezoidal rule and extrapolated to infinity was calculated according to the following equation: AUC∞ = AUCt + (Ct/ λz ), where Ct is the last quantifiable concentration. No AUC extrapolation will be performed with unreliable λz. If % AUC extrapolated is ≥ 25%, AUC∞ will not be reported|PK blood samples collected at 0.25, 0.5, 1,2,3,4, 6 and 8 hours after azacitidine administration on Day 7|The PK population includes up to 12 participants with evaluable azacitidine plasma PK profile.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
678350|NCT01599325|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAE)|A treatment-emergent adverse events (TEAE) was defined as AEs with an onset date on or after the date of first dose and within 28 days after the date of the last dose. Any AE that occurred beyond this timeframe and was assessed by the investigator as possibly related to study drug was considered treatment-emergent. The intensity and severity of AEs was assessed by the investigator according to the Common Terminology Criteria for Adverse Event (CTCAE) Version 4.0. For any AEs not listed in the CTCAE grading system, the intensities of these events was assessed by the Investigator using the 5-point scale: Grade 1 = Mild, Grade 2 = Moderate; Grade 3 = Severe, Grade 4 = Life threatening, Grade 5 = Death. An SAE is any AE occurring that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, and constitutes an important medical event.|Up to 29 January 2015; from the first dose of study drug to 28 days after the date of the last dose of study drug (maximum time on study was 244 days)|Safety population included all participants who received at least one dose of azacitidine and had at least one post-dose safety assessment||participants|||Number
678351|NCT01599325|Secondary|Kaplan Meier Estimates for Overall Survival (OS)|Overall survival is defined as time to death from any cause, is calculated using date of first dose and date of death, or date of last follow-up for censored participants. Those, who die regardless of the cause of death, will be considered to have an event.|Until the end of the survival follow-up period; Up to data cut-off of 29 January 2015; 894 days|Intent to Treat (ITT) includes all participants who were enrolled into the study.||months||95% Confidence Interval|Number
678352|NCT01599325|Secondary|The Number of Infections (Post-baseline Average) Requiring Intravenous (IV) Antibiotics, Anti-fungals, or Antivirals by Cycle|The on-treatment adverse event of infection requiring IV antibiotics, antifungals, or antivirals per 28 days/cycle. The overall post-baseline average is the average of number of infections requiring IV antibiotics or IV antiviral per 28 days/cycle.|Up to cycle 27; The on-treatment period was considered the period from the date of first dose to the last treatment study visit; Up to 29 January 2015; 894 days|Intent to Treat (ITT) includes all participants who were enrolled into the study.||Infections||Standard Deviation|Mean
678353|NCT01599325|Secondary|The Number of RBC Transfusions by Cycle|The number of RBC transfusions received 56 days prior to treatment, considered the baseline period (baseline period defined as the screening period before the date of the first dose of azacitidine; any laboratory and blood transfusion data reported on the day of the first dose of azacitidine was considered to be baseline data) and during study was standardized per 28 days and summarized by cycle for platelets. The formula for standardizing per 28 days was: [(# of transfusions in the measurement period / length of the measurement period (days)) x 28], where the measurement period was either baseline or the relevant cycle length.|Up to cycle 27; The on-treatment period was considered the period from the date of first dose to the last treatment study visit; Up to 29 January 2015; 894 days|Intent to Treat (ITT) includes all participants who were enrolled into the study.||RBC Transfusions||Standard Deviation|Mean
678354|NCT01599325|Secondary|The Number of Units of Red Blood Cell (RBC) Transfusions by Cycle|The number of units of RBC received 56 days prior to treatment, considered the baseline period (baseline period defined as the screening period before the date of the first dose of azacitidine; any laboratory and blood transfusion data reported on the day of the first dose of azacitidine was considered to be baseline data) and during study was standardized per 28 days and summarized by cycle for RBC. The formula for standardizing per 28 days was: [(# of transfusions in the measurement period / length of the measurement period (days)) x 28], where the measurement period was either baseline or the relevant cycle length.|Up to cycle 27; The on-treatment period was considered the period from the date of first dose to the last treatment study visit; Up to 29 January 2015; 894 days|ITT includes all participants who were enrolled into the study||Units of RBC Transfusions||Standard Deviation|Mean
678355|NCT01599325|Secondary|The Number of Platelet Transfusions by Cycle|The number of platelet transfusions received 56 days prior to treatment, considered the baseline period (baseline period defined as the screening period before the date of the first dose of azacitidine; any laboratory and blood transfusion data reported on the day of the first dose of azacitidine was considered to be baseline data) and during study was standardized per 28 days and summarized by cycle for platelets. The formula for standardizing per 28 days was: [(# of transfusions in the measurement period / length of the measurement period (days)) x 28], where the measurement period was either baseline or the relevant cycle length.|Up to cycle 27; The on-treatment period was considered the period from the date of first dose to the last treatment study visit; Up to 29 January 2015; 894 days|Intent to Treat (ITT) includes all participants who were enrolled into the study.||Platelet transfusions||Standard Deviation|Mean
678356|NCT01599325|Secondary|The Number of Units of Platelet Transfusions by Cycle|The number of units of platelet transfusions received 56 days prior to treatment, considered the baseline period, (baseline period defined as the screening period before the date of the first dose of azacitidine; any laboratory and blood transfusion data reported on the day of the first dose of azacitidine was considered to be baseline data) and during study was standardized per 28 days and summarized by cycle for platelets. The formula for standardizing per 28 days was: [(# of transfusions in the measurement period / length of the measurement period (days)) x 28], where the measurement period was either baseline or the relevant cycle length.|Up to cycle 27; The on-treatment period was considered the period from the date of first dose to the last treatment study visit; Up to 29 January 2015; 894 days|Intent to Treat (ITT) includes all participants who were enrolled into the study.||Units of platelet transfusions||Standard Deviation|Mean
678357|NCT01599325|Primary|Percentage of Participants Achieving a Hematologic Improvement (HI) Based on 2000 IWG Response Criteria for MDS and Programmatically Assessed by the Sponsor Using Clinically Relevant Data.|Hematologic improvements (HI) have 4 categories: 1. Erythroid response (HI-E): Major >20g/L increase or transfusion independent. Minor: 10-20g/L increase or ≥50% decrease in transfusion requirements. 2. Platelet response (HI-P): Major absolute increase of ≥30x10^9/L or platelet transfusion independence. Minor: ≥50% increase. 3. Neutrophil response (HI-N): Major 100% increase or an absolute increase of >0.5x10^9/L. Minor: ≥100% increase and absolute increase of <0.5x10^9/L 4. Progression or relapse after HI Hematological improvement (HI) was defined as any type (major or minor) of improvement of HI-E, HI-P, or HI-N. Criteria: Pretreatment=hemoglobin <100g/L or RBC transfusion-dependent, platelet count <100x10^9/L or platelet transfusion dependent, absolute neutrophil count <1.5x10^9/L. Sponsor's determination was derived using clinically relevant data. Denominator for progression/relapse after HI included participants who had achieved HI.|Up to 29 January 2015; 894 days|Intent to Treat (ITT) includes all participants who were enrolled into the study.||percentage of participants||95% Confidence Interval|Number
678358|NCT01599325|Primary|Percentage of Participants With a Hematologic Response Using IWG Criteria for MDS and Assessed by the Investigator|Hematologic Response is defined by those participants who experienced a Complete Response, Partial Response and Stable Disease (SD) based on IWG 2000 response criteria for MDS. CR = repeat bone marrow (BM) shows <5% myeloblasts, and peripheral blood values lasting ≥ 2 months of hemoglobin (hgb) (>110 g/L), neutrophils (≥1.5x10^9/L), platelets (≥100x10^9/L), blasts (0%) and no dysplasia • PR = same as CR for peripheral blood: BM shows blasts decrease by ≥ 50% or a less advanced FAB classification from pretreatment • Stable disease (SD): failure to achieve a PR, no evidence of progression for at least 2 months. • Failure: death during treatment or disease progression • Relapse After CR or PR: return to pretreatment BM blast percent or decrement of ≥ 50% from remission/response levels in granulocytes or platelets; or reduction in hgb by ≥20 g/L or transfusion dependence • Disease Progression: change in blast levels • Disease Transformation to Acute Myelogenous Leukemia.|Response initially assessed at end of cycle 6, then every 4 cycles; Up to 29 January 2015; 894 days|Intent to Treat (ITT) includes all participants who were enrolled into the study.||percentage of participants||95% Confidence Interval|Number
678411|NCT01598428|Secondary|Uncorrected Visual Acuity(UCVA)|The UCVA was recorded in logMAR units at each vist|1 day，1 week, 1 month as well as 3 months and 6 months postoperatively|||logMAR|Participants|Standard Deviation|Mean
678359|NCT01599325|Primary|Percentage of Participants With a Hematologic Response Based on the International Working Group (IWG) Criteria for Myelodysplastic Syndrome (MDS) and Programmatically Assessed by the Sponsor Using Clinically Relevant Data.|Hematologic Response is defined by those participants who experienced a Complete Response, Partial Response and Stable Disease (SD) based on IWG 2000 response criteria for MDS. CR = repeat bone marrow (BM) shows <5% myeloblasts, and peripheral blood values lasting ≥ 2 months of hemoglobin (hgb) (>110 g/L), neutrophils (≥1.5x10^9/L), platelets (≥100x10^9/L), blasts (0%) and no dysplasia • PR = same as CR for peripheral blood: BM shows blasts decrease by ≥ 50% or a less advanced FAB classification from pretreatment • Stable disease (SD): failure to achieve a PR, no evidence of progression for at least 2 months. • Failure: death during treatment or disease progression • Relapse After CR or PR: return to pretreatment BM blast percent or decrement of ≥ 50% from remission/response levels in granulocytes or platelets; or reduction in hgb by ≥20 g/L or transfusion dependence • Disease Progression: change in blast levels • Disease Transformation to Acute Myelogenous Leukemia.|Response initially assessed at end of cycle 6, then every 4 cycles; Up to 29 January 2015; 894 days|Intent to Treat (ITT) includes all participants who were enrolled into the study.||percentage of participants||95% Confidence Interval|Number
678360|NCT01599234|Secondary|Number of Subjects With a 50% or Greater Improvement in Mean Spasticity 0-10 NRS Score at the End of Treatment Compared to Baseline|"The cumulative response to treatment was the percentage change from baseline in the mean NRS spasticity score as defined as the 50% response. The spasticity NRS was completed at the same time each day, i.e. bedtime in the evening. The subject was asked on a scale of '0 to 10', please indicate the number that best describes your spasticity in the last 24 hours where 0 = no spasticity and 10 = worst possible spasticity. The number of responders at the 50% level is presented."|0 - 15 weeks|All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the analysis||participants|||Number
678361|NCT01599234|Secondary|Change From Baseline in the Mean Total Barthel Activities of Daily Living Index Score at the End of Treatment|The Barthel Index consists of 10 items that measure a person's daily functioning specifically the activities of daily living and mobility. The items include feeding, moving from wheelchair to bed and return, grooming, transferring to and from a toilet, bathing, walking on level surface, going up and down stairs, dressing, continence of bowels and bladder. The person receives a score based on whether they have received help while doing the task. The scores for each of the items are summed to create a total score of 100. An increase in score indicates an improvement.|Day 0 (Randomisation) and Day 99 (End of Treatment)|All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the analysis||units on a scale||Standard Deviation|Mean
678362|NCT01599234|Secondary|Carer Global Impression of Change at the End of Treatment|The carer of the subject gave their opinion of any noticeable change in the subject’s overall functional ability at the end of the study. A 7-point Likert-type scale was used, with the markers “very much improved, much improved, slightly improved, no change, slightly worse, much worse or very much worse”. The number of carers who reported an improvement at the end of treatment is presented.|Day 99 (end of treatment)|All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the analysis, as were a further two subjects who were excluded from the full analysis set as a result of no on-treatment efficacy data||participants|||Number
678363|NCT01599234|Secondary|Change From Baseline in Mean Timed 10 Metre Walk Time at the End of Treatment|Only those subjects for whom it was appropriate (i.e. ambulatory subjects) were timed how long it took to walk 10 metres. Walk time was only assessed for subjects who successfully completed the Timed 10 Metre Walk. A negative difference from baseline indicates an improvement walk time.|Day 0 (Randomisation) and Day 99 (End of Treatment)|All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the analysis||time (seconds)||Standard Deviation|Mean
678364|NCT01599234|Secondary|Incidence of Adverse Events as a Measure of Subject Safety|The number of subjects who experienced and adverse event during the course of the study is presented|0-15 weeks|All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the analysis, as were a further two subjects who were excluded from the full analysis set (used for the efficacy analysis) as a result of no on-treatment efficacy data||participants|||Number
678365|NCT01599234|Secondary|Change From Baseline in Mean Sleep Quality 0-10 NRS During the Last 14 Days of Treatment (End of Treatment)|"The sleep disruption NRS was completed at the same time each day, i.e. bedtime in the evening. The subject was asked on a scale of '0 to 10', please indicate how your spasticity disrupted your sleep last night? where 0 = did not disrupt sleep and 10 = completely disrupted (unable to sleep at all). A negative value indicates an improvement in sleep disruption score from baseline."|0-15 weeks|All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the analysis||units on a scale||Standard Deviation|Mean
678366|NCT01599234|Secondary|Change From Baseline in the Mean Modified Ashworth Scale Score at the End of Treatment|All 20 muscle groups were assessed for spasticity (using a 1-5 scale): 1= no increase in muscle tone to 5= passive movement is difficult and affected part is rigid in flexion or extension. The score for all 20 muscle groups were added to give a total score out of 100; minimum score was 20. A decrease in score indicates an improvement in condition.|Day 0 (Randomisation) and Day 99 (End of Treatment)|All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the analysis||units on a scale||Standard Deviation|Mean
678367|NCT01599234|Secondary|Number of Subjects With a 30% or Greater Improvement in Mean Spasticity 0-10 NRS Score at the End of Treatment Compared to Baseline|"The cumulative response to treatment was the percentage change from baseline in the mean NRS spasticity score as defined as the 30% response. The spasticity NRS was completed at the same time each day, i.e. bedtime in the evening. The subject was asked on a scale of '0 to 10', please indicate the number that best describes your spasticity in the last 24 hours where 0 = no spasticity and 10 = worst possible spasticity. The number of responders at the 30% level is presented."|0-15 weeks|All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the analysis||participants|||Number
683532|NCT01525849|Secondary|Complication Rate|Number of participants experiencing 1 or more serious adverse events related to the device and/or procedure|Duration of study (minimum of 12 months)|All randomized participants||Participants|||Count of Participants
678368|NCT01599234|Primary|Change From Baseline in Mean Spasticity 0-10 Numerical Rating Scale (NRS) Score During the Last 14 Day of Treatment (End of Treatment)|"The average spasticity NRS was completed at the same time each day, i.e. bedtime in the evening. The subject was asked on a scale of '0 to 10', please indicate the number that best describes your spasticity in the last 24 hours where 0 = no spasticity and 10 = worst possible spasticity. A negative value indicates an improvement in pain score from baseline."|0-15 weeks|All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the analysis||units on a scale||Standard Deviation|Mean
678369|NCT01599104|Secondary|Number of Patients With Adverse Events, Serious Adverse Events and Death|Participants were monitored for adverse events, serious adverse events and deaths throughout the study.|8 weeks|Safety Set. The safety set included aqll participants who had received study medication.||Participants|||Number
678370|NCT01599104|Secondary|Change From Baseline in Mean 24-hour Ambulatory Pulse Pressure|Ambulatory pulse pressure was calculated as hourly ambulatory SBP minus hourly ambulatory DBP in a subset of participants.|Baseline, 8 weeks|The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline ABPM measurements. This outcome measure was analyzed in a subset of participants within each treatment group where n = 216 for the LCZ 200 mg group, n = 216 for the LCZ 400 mg group and n = 200 for the Olmesartan group.||mmHg||Standard Error|Least Squares Mean
678371|NCT01599104|Secondary|Change From Baseline in Office Pulse Pressure|Office pulse pressure was calculated as msSBP minus msDBP. Sitting blood pressure (BP) measurement was performed at screening through the end of study at every visit. Four separate sitting BP were obtained with a full two-minute interval between measurement. The 4 measurements were summed and then averaged to calculate the mean BP value. The baseline PP value was subtracted from the week 8 PP value to determine the change from baseline in PP.|Baseline, 8 weeks|The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline BP measurements.||mmHg||Standard Error|Least Squares Mean
678372|NCT01599104|Secondary|Change From Baseline in maSBP and maDBP for Daytime/Nighttime|ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants.|Baseline, 8 weeks|The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline ABPM measurements. This outcome measure was analyzed in a subset of participants within each treatment group where n = 216 for the LCZ 200 mg group, n = 216 for the LCZ 400 mg group and n = 200 for the Olmesartan group.||mmHg||Standard Error|Least Squares Mean
678373|NCT01599104|Secondary|Change From Baseline in Mean 24-hour Ambulatory DBP (maDBP) at Week 8|ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants.|Baseline, 8 weeks|The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline ABPM measurements. This outcome measure was analyzed in a subset of participants within each treatment group where n = 216 for the LCZ 200 mg group, n = 216 for the LCZ 400 mg group and n = 200 for the Olmesartan group.||mmHg||Standard Error|Least Squares Mean
678374|NCT01599104|Secondary|Percentage of Participants Achieving a Successful msDBP Response|Successfull msDBP response was defined as <90 mmHg or ≥10 mmHg reduction from baseline.|8 weeks|The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline BP measurements.||Percentage of participants|||Number
678375|NCT01599104|Secondary|Percentage of Participants Achieving a Successful msSBP Response|Successful msSBP response was defined as < 140 mmHg or ≥ 20 mmHg reduction from baseline.|8 weeks|The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline BP measurements.||Percentage of participants|||Number
678376|NCT01599104|Secondary|Percentage of Participants Achieving a Successful Response in Overall Blood Pressure Control at Week 8|A successful response in overall BP control rate was defined as msSBP < 140 mmHg and msDBP <90 mmHg.|8 weeks|The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline BP measurements.||Percentage of participants|||Number
678377|NCT01599104|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)|Sitting BP measurement was performed at screening through the end of study at every visit. Four separate sitting BP were obtained with a full two-minute interval between measurement. The 4 measurements were summed and averaged, and then the baseline BP value was subtracted from the average value to get the change from baseline.|Baseline, 8 weeks|The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline BP measurements.||mmHg||Standard Error|Least Squares Mean
678378|NCT01599104|Secondary|Change From Baseline in Mean 24-hour Ambulatory SBP (maSBP) at Week 8|Ambulatory blood pressure monitoring (ABPM) over a 24-hour period was conducted at two time-points during the study in a subset of participants.|Baseline, 8 weeks|The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline ABPM measurements. This outcome measure was analyzed in a subset of participants within each treatment group where n = 216 for the LCZ 200 mg group, n = 216 for the LCZ 400 mg group and n = 200 for the Olmesartan group.||mmHg||Standard Error|Least Squares Mean
678379|NCT01599104|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)|Sitting BP measurements were performed at screening through the end of study at every visit. Four separate sitting BP were obtained with a full two-minute interval between measurements. The 4 measurements were summed and averaged, and then the baseline BP value was subtracted from the average value to get the change from baseline.|Baseline, 8 weeks|Full Analysis Set (FAS): The full analysis set included all randomized participants who received study medication and had both baseline and post-baseline BP assessments.||mmHg||Standard Error|Least Squares Mean
678380|NCT01598987|Secondary|Growth Development - Height at Baseline and Month 24|"Individual growth measurements were compared with the gender and age-specific growth percentiles in the CDC growth charts for the US population. Each value observed is thus represented by the (approximated) percentage of subjects with a lower value in the reference population. Changes were calculated on this scale and thus express the change in growth measurements relative to the percentiles in the CDC growth charts.
Patients were classified into growth percentile categories (<=5, >5-25, >25-50, >50-75, >75-95 and >95% percentile)."|Baseline, Month 24|Safety Analysis Set||Percentages|||Number
678381|NCT01598987|Secondary|Growth Development - Weight at Baseline and Month 24|"Individual growth measurements were compared with the gender and age-specific growth percentiles in the CDC growth charts for the US population. Each value observed is thus represented by the (approximated) percentage of subjects with a lower value in the reference population. Changes were calculated on this scale and thus express the change in growth measurements relative to the percentiles in the CDC growth charts.
Patients were classified into growth percentile categories (<=5, >5-25, >25-50, >50-75, >75-95 and >95% percentile)."|Baseline, Month 24|Safety Analysis Set||Percentages|||Number
678382|NCT01598987|Secondary|Growth Development - Weight at Baseline and Month 12|"Individual growth measurements were compared with the gender and age-specific growth percentiles in the CDC growth charts for the US population. Each value observed is thus represented by the (approximated) percentage of subjects with a lower value in the reference population. Changes were calculated on this scale and thus express the change in growth measurements relative to the percentiles in the CDC growth charts.
Patients were classified into growth percentile categories (<=5, >5-25, >25-50, >50-75, >75-95 and >95% percentile)."|Baseline, Month 12|Safety Analysis Set||Percentages|||Number
678383|NCT01598987|Secondary|Growth Development - Height at Baseline and Month 12|"Individual growth measurements were compared with the gender and age-specific growth percentiles in the CDC growth charts for the US population. Each value observed is thus represented by the (approximated) percentage of subjects with a lower value in the reference population. Changes were calculated on this scale and thus express the change in growth measurements relative to the percentiles in the CDC growth charts.
Patients were classified into growth percentile categories (<=5, >5-25, >25-50, >50-75, >75-95 and >95% percentile)."|Baseline, Month 12|Safety Analysis Set||Percentages|||Number
678384|NCT01598987|Secondary|Change From Baseline in Estimated Glomerular Filtration Rate - Month 24|Evolution of renal function assessed by estimated Glomerular Filtration Rate (eGFR) calculated by the Chronic Kidney Disease in Children (CKiD) Schwartz formula (Schwartz 2009), expressed in mean change in eGFR of CKiD between start of study (baseline assessment) and Month 24.|Baseline, Month 24|Full analysis set||mL/min/1.73m2||Standard Deviation|Mean
678385|NCT01598987|Secondary|Kaplan-Meier Estimates for Failure Rates of Efficacy Endpoints|"The proportion of patients with composite efficacy failure (treated biopsy proven acute rejection[tBPAR], graft loss [GL] , death [D]) before/at Month 12 and Month 24, estimated with Kaplan-Meier (KM) methods and the proportion of patients who experienced any of the components of composite efficacy failure (tBPAR, GL, D) before/at Month 12 and Month 24, separately for each component.
AR: acute rejection; BPAR: biopsy proven acute rejection. Rate = Kaplan-Meier estimate for failure in %; CI = confidence interval for failure rate."|At 12-month and 24-month after start of study drug|Full Analysis Set||Percentages||80% Confidence Interval|Number
678386|NCT01598987|Primary|Change From Baseline in Estimated Glomerular Filtration Rate - Month 12|Evolution of renal function assessed by estimated Glomerular Filtration Rate (eGFR) calculated by the Chronic Kidney Disease in Children (CKiD) Schwartz formula (Schwartz 2009), expressed in mean change in eGFR of CKiD between start of study (baseline assessment) and Month 12.|Baseline, Month 12|Full Analysis Set||mL/min/1.73m^2||Standard Deviation|Mean
678387|NCT01598779|Primary|Human Papillomavirus (HPV) Types in External Genital Warts (EGW)|150 biopsies with histological diagnosis of genital warts were analyzed by PCR to detect HPV type|4 months|Biopsied from genital warts were taken with an excisional procedure under local anesthesia. Biopsied sample was splinted in order to obtain two pieces, All biopsies were analyzed to confirm the histological diagnosis of genital warts. The other piece was sent to the laboratory to investigate the presence of HPV 6 and 11.||percentage of participants|||Number
678388|NCT01598740|Secondary|Change in Fecal Weight|Change = (Days 10-13/29-32 Daily Average) - (Days 3-6/22-25 Daily Average)|baseline average (days 3-6 or 22-25) and treatment average (days 10-13 or 29-32)|||grams||Standard Deviation|Mean
678389|NCT01598740|Primary|Change in Fecal Sodium Content|Change =(Days 10-13/29-32 Daily Average)-(Days 3-6/22-25 Daily Average)|baseline average (days 3-6 or days 22-25) and treatment average (days 10-13 or 29-32)|||mg||Standard Deviation|Mean
678390|NCT01598610|Secondary|Number of Subject Responses 'Strongly Agree' 'Agree' or 'Neutral' With Questionnaire Statements|Subjects respond to statements read by study staff to provide feedback on the labeling materials and system ease of use. Subjects may respond 'Strongly Agree' 'Agree' 'Neutral' 'Disagree' or 'Strongly Disagree'.|1 hour|Per protocol||participants|||Number
678391|NCT01598610|Secondary|Percent of Subject Fingerstick BG Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method When Tested by Study Staff|Study staff test subject fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. BG results are used to calculate the number of BGMS results within +/- 15mg/dL (<75mg/dL YSI capillary plasma) or +/- 20% (>=75mg/dL YSI capillary plasma) of the reference method results.|1 hour|217 (220-3) blood test results were analyzed. Blood data for 2 subjects were not evaluable because time, defined in protocol, was exceeded between meter test and blood sample preparation for reference method. No fingerstick results were obtained for 1 subject.||percentage of BG Test Results|||Number
678392|NCT01598610|Secondary|Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 5to15mg/dL (<100mg/dL) or Within +/- 5to15% (>=100mg/dL) of Laboratory Glucose Method|Untrained subjects with diabetes self-test fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. BG results are used to calculate the number of BGMS results within +/- 5to15mg/dL (<100mg/dL YSI capillary plasma) or +/- 5to15% (>=100mg/dL YSI capillary plasma) of the reference method results.|1 hour|108 (110-2) blood test results from one test strip lot were analyzed. Blood data for 1 subject was not evaluable because time, defined in protocol, was exceeded between meter test and blood sample preparation for reference method. No fingerstick result was obtained for 1 subject.||percentage of BG Test Results|||Number
678412|NCT01598428|Primary|Effective Lens Position|Effective lens position was measured with anterior chamber depth 1 day，1 week, 1 month as well as 3 months and 6 months postoperatively using anterior segment Optical Coherence Tomograph. The anterior chamber depth defined as the distance between the posterior surface of the corneal and anterior surface of intraocular lens in the pupil center along the optical axis. The actual movement of intraocular lenses was defined as the root mean square of changes in the effective lens position at each visit.|1 day，1 week, 1 month，3 months and 6 months postoperatively|||mm|Participants|Standard Deviation|Mean
678393|NCT01598610|Secondary|Percent of Venous Blood Glucose Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method|Study staff tested subject venous blood using an investigational Blood Glucose Monitoring System (BGMS). Venous BGMS results are compared with venous plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. Venous plasma BG results are used to calculate the number of BGMS results within +/- 15mg/dL (<75mg/dL YSI venous plasma) or +/- 20% (>=75mg/dL YSI venous plasma) of the reference method results.|1 hour|213 (220-7) blood test results were analyzed. Venipuncture was unsuccessful for 6 subjects. Blood data for 1 subject was not evaluable because time, defined in protocol, was exceeded between meter test and blood sample preparation for reference method.||percentage of BG Test Results|||Number
678394|NCT01598610|Secondary|Percent of Glucose Results From Alternative Site Testing (AST) of the Palm Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method|Untrained subjects with diabetes self-test Alternative Site (AST) Palm blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS AST results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. BG results are used to calculate the number of AST BGMS results within +/- 15mg/dL (<75mg/dL YSI capillary plasma) or +/- 20% (>=75mg/dL YSI capillary plasma) of the reference method results.|1 hour|213 (220-7) blood test results were analyzed. Four(4) subjects had low blood sugar and AST results were not evaluable per protocol. One(1) subject with low blood sugar (AE) did not attempt AST testing per protocol. No AST palm results were obtained for 2 subjects.||percentage of BG Test Results|||Number
678395|NCT01598610|Primary|Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method|Untrained subjects with diabetes self-test fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. BG results are used to calculate the number of BGMS results within +/- 15mg/dL (<75mg/dL YSI capillary plasma) or +/- 20% (>=75mg/dL YSI capillary plasma) of the reference method results.|1 hour|216 (220-4) blood test results were analyzed. Blood data for 2 subjects were not evaluable because time, defined in protocol, was exceeded between meter test and blood sample preparation for reference method. No fingerstick results were obtained for 2 subjects.||percentage of BG Test Results|||Number
678396|NCT01598545|Secondary|Pain Scores, Visual Analogue Pain Scale|Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).|24 hours after intrathecal injection|||units on a scale||Full Range|Mean
678397|NCT01598545|Secondary|Pain Scores, Visual Analogue Pain Scale|Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).|18 hours after intrathecal injection|||units on a scale||Full Range|Mean
678398|NCT01598545|Secondary|Pain Scores, Visual Analogue Pain Scale|Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).|6 hours after intrathecal injection|||units on a scale||Full Range|Mean
678399|NCT01598545|Secondary|Pain Scores, Visual Analogue Pain Scale|Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).|Baseline|||units on a scale||Full Range|Mean
678400|NCT01598545|Primary|Pain Scores, Visual Analogue Pain Scale|Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).|12 hours after intrathecal injection|||units on a scale||Full Range|Mean
678401|NCT01598532|Primary|Digit Span, Forwards and Backwards|Digit Span, Forwards and Backwards measures short-term auditory memory and working memory that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes.|Baseline and 1-Week, 1-Month and 2-Months after final LED Treatment|All participants enrolled in the Transcranial LED Treatment Group||# of SD units||Standard Deviation|Mean
678402|NCT01598532|Primary|Controlled Oral Word Association Test (FAS)|Controlled Oral Word Association Test (FAS) measures verbal fluency that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes.|Baseline and 1-Week, 1-Month and 2-Months after final LED Treatment|All participants enrolled in the Transcranial LED Treatment Group||# of SD units||Standard Deviation|Mean
678403|NCT01598532|Primary|California Verbal Learning Test-II (CVLT-II) Long Delay Free Recall|California Verbal Learning Test-II (CVLT-II) Long Delay Free Recall measures word recall after a 20 minute delay that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes.|Baseline and 1-Week, 1-Month and 2-Months after final LED Treatment|All participants enrolled in Transcranial LED Treatment Group||# of SD Units||Standard Deviation|Mean
678404|NCT01598532|Primary|California Verbal Learning Test-II (CVLT-II) Total, Trials 1-5|California Verbal Learning Test-II (CVLT-II) Total, Trials 1 - 5 measures word recall on trials 1-5 that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes.|Baseline and 1-Week, 1-Month and 2-Months after Final LED Treatment|All participants enrolled in Real Intervention Group||# of SD Units||Standard Deviation|Mean
678405|NCT01598532|Primary|Stroop Test for Executive Function - Trial 4 Inhibition Switching|Stroop Test for Executive Function - Trial 4 (D-KEFS) Inhibition Switching that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes.|Baseline and 1-Week, 1-Month and 2-Months after the Final LED Treatment|All participants enrolled in Transcranial LED Treatment Group||# of SD Units||Standard Deviation|Mean
678406|NCT01598532|Primary|Stroop Test for Executive Function - Trial 3 - Inhibition|Stroop Test for Executive Function - Trial 3 (D-KEFS) - Inhibition measures executive function, inhibition that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes.|Baseline and 1-Week, 1-month and 2-months after final LED Treatment|All participants enrolled in the Transcranial LED Treatment Group||# of SD units||Standard Deviation|Mean
678407|NCT01598506|Secondary|Pain Score, Visual Analogue Pain Scores|Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).|30 minutes after intrathecal injection|||units on a scale||Full Range|Mean
678408|NCT01598506|Secondary|Pain Scores, Visual Analogue Pain Scale|Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).|Baseline|||units on a scale||Full Range|Mean
678409|NCT01598506|Primary|Change in Pain Score|Change in pain score was calculated by subtracting the 30 minute pain score from the baseline pain score.The pain scores were on a continuous visual analogue scale of 0 - 10 (0=no pain, 10=worst imaginable pain).|Baseline, 30 minutes|||units on a scale||Full Range|Mean
678413|NCT01598350|Primary|Step Width||60 minutes|||cm||Standard Deviation|Mean
678415|NCT01598207|Secondary|Sensory Thresholds for Discomfort|When participants felt pain at earliest pressure; range 0-65 mmHg|Baseline and 1 month|1 participant in marinol and 1 participant in placebo did not have this information completed||mmHg||Standard Deviation|Mean
678416|NCT01598207|Secondary|Duration of Chest Pain Episodes|0 - is none and 3 is longer than 30 mins; higher values is worst outcome; chest pain totals are averaged|Baseline vs 1 month|1 participant in placebo did not have this information completed||units on a scale||Standard Deviation|Mean
678417|NCT01598207|Secondary|Sensory Thresholds for First Sensation|This is determined by the Esophageal Balloon Distension Test; range 0-65 mmHg|Baseline and 1 month|||mmHg||Standard Deviation|Mean
678418|NCT01598207|Secondary|Intensity of Chest Pain Episodes|Intensity (0(none) - 3(severe)) at baseline vs 1 month for chest pain episodes; higher represents worse outcome; multiple chest pain totals are averaged|Baseline and 1 month|1 participant in placebo did not have this information completed||units on a scale||Standard Deviation|Mean
678419|NCT01598207|Secondary|Frequency of Chest Pain in Treatment Group vs Baseline|Total (intensity (0(none) - 3(severe) + duration (0(none) - 3(longer than 30 mins)) at end of 1 month treatment; higher represents worse outcome; the total score ranges from 0 to 6 and is the sum of the intensity and duration|1 month|1 participant in placebo did not have this information completed||units on a scale||Standard Deviation|Mean
678420|NCT01598207|Primary|Frequency of Chest Pain Episodes|Number of people still experiencing the same amount of chest pain during treatment than previously without|Baseline and 1 month|||participants|||Number
678421|NCT01598129|Primary|Recommended Phase 2 Dose by Identification of Any Dose Limiting Toxicities|No Dose Limiting Toxicities were observed at any dose level.|6 months|||Dose limiting toxicities|||Number
678422|NCT01598129|Other Pre-specified|Number of Patients With Induction of Tumor-specific CD8+ T Cells in Peripheral Blood Monomuclear Cells.||6 months|||participants|||Number
678423|NCT01598129|Other Pre-specified|Number of Participants With Infiltration of CD8+ T Cells Into Tumors.||6 months|||participants|||Number
678424|NCT01598129|Other Pre-specified|An Immune Response to Treatment Was Assessed by Measuring a Temporary Increase in Pro-inflammatory Cytokines After Treatment Was Administrered.||6 hours|||participants|||Number
678425|NCT01598129|Other Pre-specified|Quality of Life Using EORTC QLQ-C30.|To assess the feasibility and usefulness of EORTC QLQ-C30 for possible use in later studies.|12 months||||||
678426|NCT01598129|Other Pre-specified|Number of Participants With Stable Disease Status as Defined by Response Evaluation Criteria In Solid Tumors (RECIST) Evaluation Three Months After Starting CGTG-102 Treatment.||3 months|||participants|||Number
678427|NCT01598129|Secondary|To Determine the Safety, Tolerability and Adverse Event Profile of CGTG-102 With Low-dose CPO. To Obtain Preliminary Evidence of Antitumour Activity.|Clinical and laboratory assessment. Response rate, disease control rate, progression free and overall survival.|12 months||||||
678428|NCT01598129|Primary|Number of Participants With Any (Serious and Non-Serious) Adverse Event Measured to Assess Safety and Tolerability.||6 months|||participants|||Number
678429|NCT01598064|Secondary|Liver Function Evaluation|Measure ALT level of patients|8 weeks|||U/L||Standard Deviation|Mean
678430|NCT01598064|Primary|Admission Due to Complications Related to Portal Hypertension||8 weeks|||participants|||Number
678431|NCT01597908|Secondary|Duration of Response, as Assessed by the Investigator|Duration of response is defined as the time from the first documented evidence of a CR (disappearance of all evidence of target lesions) or a PR (at least a 30% reduction from Baseline in the sum of the longest diameter of all target lesions) until disease progression or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of at least1 new lesion, or the worsening of non-target lesions significant enough to require study treatment discontinuation. Data are summarized per RECIST, Version 1.1.|From the first documented evidence of a CR or PR until the earliest date of disease progression or death due to any cause (up to Study Week 80)|ITT Population. Only those participants with a confirmed response (CR and PR) were analyzed. Participants with measurable and non-measurable disease were analyzed.||Months||95% Confidence Interval|Median
678432|NCT01597908|Secondary|Overall Response, as Assessed by the Investigator|Overall response is defined as the number of responders (complete response [CR] + partial response [PR] per RECIST, Version 1.1) as summarized by Investigator assessment. CR is defined as the disappearance of all evidence of target lesions. PR is defined as at least a 30% reduction from Baseline in the sum of the longest diameter (LD) of all target lesions. Data are reported as those participants with measureable disease.|Screening, Week 8 and every 8 weeks thereafter through Week 56, and then every 12 weeks|ITT Population||Participants|||Number
678433|NCT01597908|Secondary|Progression-free Survival, as Assessed by the Investigator|Progression-free survival (PFS) is defined as the time from randomization to the first documented occurrence of disease progression or death due to any cause. PFS for investigator-assessed response was summarized per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1, which is a set of published rules defining when cancer patients improve (respond), stay the same (stabilize), or worsen (progress) during treatment. Disease progression is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 millimeters (mm) or the appearance of at least 1 new lesion, or the worsening of non-target lesions significant enough to require study treatment discontinuation.|From randomization to the first documented occurrence of disease progression or death due to any cause (up to Study Week 80)|ITT Population. Participants who did not progress or die or who progressed or died after the start of new anti-cancer therapy or after an extended period without adequate assessment were censored at their date of last adequate assessment prior to progression or death even if subsequent information was available regarding progression or death.||Months||95% Confidence Interval|Median
678434|NCT01597908|Primary|Overall Survival|Overall survival is defined as the time from randomization until death due to any cause.|From randomization until death due to any cause (up to Study Week 92)|Intent-to-Treat (ITT) Population: all randomized participants, whether or not study medication was administered. All participants in the ITT Population were analyzed. For participants who did not die, time of death was censored at the date of last contact.||Months||95% Confidence Interval|Median
678435|NCT01597843|Primary|Registration for MHV|Measured by response to question: Have you ever used My HealtheVet online?|Baseline; After Group 1 Intervention; After Group 2 Intervention|Respondents to first round survey||Percentage of respondents who use MHV|||Number
678437|NCT01597635|Secondary|Immunogenicity Assessment With Respect to Anti-ACE2 Binding Antibodies at Follow-up Day 14 and Follow-up Day 28 (Part B)|Blood samples for immunogenicity analysis were collected at follow-up (Day 14) and follow-up (Day 28). Antibodies to GSK2586881 were measured using a validated electrochemiluminescence bridging assay. All pre-dose and post-dose samples were first tested for Anti-ACE2 binding antibodies by screening and confirmation assay steps. The post-dose samples tested positive for anti-ACE2 binding antibodies were further characterized for anti-ACE2 neutralizing antibodies. Testing was conducted using a tiered approach; samples were first tested in a screening assay, only samples found positive in this assay were tested in the confirmation assay.|Follow-up (Day 14 )and follow-up (Day 28)|The All Subjects – Part B Population. Only those participants available at the specified time points were analyzed.||Participants|||Number
678438|NCT01597635|Secondary|Immunogenicity Assessment With Respect to Anti-Acetychollinesterase2 (ACE2) Binding Antibodies at Follow-up Day 14 and Follow-up Day 28 (Part A)|Blood samples for immunogenicity analysis were collected at follow-up (Day 14) and follow-up (Day 28). Antibodies to GSK2586881 were measured using a validated electrochemiluminescence bridging assay. All pre-dose and post-dose samples were first tested for Anti-ACE2 binding antibodies by screening and confirmation assay steps. The post-dose samples tested positive for anti-ACE2 binding antibodies were further characterized for anti-ACE2 neutralizing antibodies. Testing was conducted using a tiered approach; samples were first tested in a screening assay, only samples found positive in this assay were tested in the confirmation assay.|Follow-up (Day 14) and follow-up (Day 28)|The All Subjects – Part A Population. Only those participants available at the specified time points were analyzed.||Participants|||Number
678439|NCT01597635|Secondary|Biomarker Analysis for Markers of Lung Epithelial Cell Injury Clara Cell Protein 16 [CCP16]) and Surfactant Protein D [SP-D] Upto Day 5 (Part B)|Markers of lung epithelial cell injury included CCP16 and SP-D. Blood samples for biomarker analyses were collected 12 hours, 24 hours, 48 hours, 72 hours and 120 hours upto Day 5. Data has been presented for median along with the 95% credible interval.|12 hours, 24 hours, 48 hours, 72 hours and 120 hours upto Day 5|The All Subjects – Part B Population. Only those participants available at the specified time points were analyzed.||nanograms per milliliter||95% Confidence Interval|Median
678440|NCT01597635|Secondary|Biomarker Analysis for Serum Inflammatory Biomarker C-reactive Protein (CRP) Upto Day 5 (Part B)|Serum inflammatory biomarker included CRP. Blood samples for biomarker analyses were collected 12 hours, 24 hours, 48 hours, 72 hours and 120 hours upto Day 5. Data has been presented for median along with the 95% credible interval.|12 hours, 24 hours, 48 hours, 72 hours and 120 hours upto Day 5|The All Subjects – Part B Population. Only those participants available at the specified time points were analyzed.||milligrams per deciliter||95% Confidence Interval|Median
678441|NCT01597635|Secondary|Biomarker Analysis for Serum Inflammatory Biomarkers, Markers of Neutrophil Activation, Markers of Lung Epithelial Cell Injury, Renin Levels and Aldosterone Levels Upto Day 5 (Part B)|Serum inflammatory biomarkers included CXCL-8 [IL-8], IL-6, markers of neutrophil activation included (e.g. myeloperoxidase [MPO]), markers of lung epithelial cell injury included receptor for advanced glycation end-products [RAGE], Angiopoietin 2, along with rennin, aldosterone levels. Blood samples for biomarker analyses were collected 12 hours, 24 hours, 48 hours, 72 hours and 120 hours upto Day 5. Data has been presented for median along with the 95% credible interval.|12 hours, 24 hours, 48 hours, 72 hours and 120 hours upto Day 5|The All Subjects – Part B Population. Only those participants available at the specified time points were analyzed.||picograms per milliliter||95% Confidence Interval|Median
678442|NCT01597635|Secondary|Evaluation of Sequential Organ Failure Assessment (SOFA) Score on Day 4 and Day 7 (Part B)|The SOFA score is a mortality prediction score that is based on the degree of dysfunction of 6 organ systems (respiratory, nervous, cardiovascular, liver, coagulation, and kidneys). The score ranges from 0-24. 0 (normal) to 4 (high degree of dysfunction) is given for each organ system, with a higher score indicating greater severity. A score of 0-6 is associated with a mortality rate of less than 10% while a score between 16 and 24 is associated with a greater than 90% mortality rate.|Day 4 and Day 7|The All Subjects – Part B Population. Only those participants available at the specified time points were analyzed.||Score on scale||95% Confidence Interval|Mean
678443|NCT01597635|Secondary|Number of Participants With Acute Kidney Injury as Defined by Day 1 to Day 3 Change in Risk, Injury, Failure, Loss of Kidney Function, and End-stage Kidney Disease (RIFLE) Criteria Upto Day 3 (Part B)|The RIFLE score is made up of the glomerular filtration rate criteria (GFRC) and urine output criteria (UOC) and is defined as Risk (Serum Creatinine x 1.5 or GFR decrease > 25%-GFRC and < 0.5 milliliter/kilograms/hour [ml/kg/hour] x 6 hours-UOC), Injury (Serum Creatinine x 2 or GFR decrease > 50%-GFRC and < 0.5 ml/kg/hour x 12 hours), Failure (Serum Creatinine x 3, or GFR decrease > 75% [F=Failure] or Serum Creatinine >=4 milligrams/deciliter [mg/dl] with an acute rise > 0.5 mg/dl [Fc=Failure acute on chronic] and < 0.3 ml/kg/hour x 24 hours, or anuria x 12 hours [Fo=Failure oligouria]). Due to the duration of this study it was not possible to be calculate the designated RIFLE class Loss and RIFLE class End-stage kidney disease. Data has been presented for rifle score total, rifle score GFR and rifle score urine. Abbreviations NAKI= No acute kidney injury, R=risk, I=injury, MISS= Unable to derive score.|Upto Day 3|The All Subjects – Part B Population.||Participants|||Number
678444|NCT01597635|Secondary|Measure of Oxygenation Index Upto Day 7 (Part B)|Oxygenation index was defined as calculation used in intensive care medicine to measure the fraction of inspired oxygen (FiO2) and its usage within the body and was computed using the equation Oxygenation Index= FiO2 x Mean Airway Pressure/Pao2. Assessments were performed at 0.5, 1, 2, 4, 6, 8, 12, 18, 24, 24.5, 25, 26, 28, 30, 32, 36, 42, 48, 48.5, 49, 50, 52, 54, 56, 60, 66, 72 and 168 hours upto Day 7. Data has been presented for median along with the 95% credible interval.|0.5, 1, 2, 4, 6, 8, 12, 18, 24, 24.5, 25, 26, 28, 30, 32, 36, 42, 48, 48.5, 49, 50, 52, 54, 56, 60, 66, 72 and 168 hours upto Day 7|The All Subjects – Part B Population. Only those participants available at the specified time points were analyzed.||Percentage||95% Confidence Interval|Median
678951|NCT01590563|Secondary|Occurrence of Malposition, Expulsion.|Expulsion and malposition are established risks involved with IUD use. Occurrence of these risks may drastically reduce effectiveness. It is expected that the IUB(tm) form will reduce these risks.|12 months|||Number of cases|||Number
678445|NCT01597635|Secondary|Measure of Oxygenation Including Fraction of Inspired Oxygen/ Partial Pressure of Oxygen in Arterial Blood (PaO2/FiO2) Ratio Via Pulse Oximetry Upto Day 7 (Part B)|"Measure of oxygenation included PaO2/FiO2 ratio defined as the ratio of arterial oxygen partial pressure to fractional inspired oxygen by pulse oximeter a device that measured the oxygen saturation of arterial blood in a participant by utilizing a sensor attached typically to a finger, toe, or ear to determine the percentage of oxyhemoglobin in blood pulsating through a network of capillaries.
Assessments were performed at 0.5, 1, 2, 4, 6, 8, 12, 18, 24, 24.5, 25, 26, 28, 30, 32, 36, 42, 48, 48.5, 49, 50, 52, 54, 56, 60, 66, 72 and 168 hours upto Day 7. Data has been presented for median along with the 95% credible interval."|0.5, 1, 2, 4, 6, 8, 12, 18, 24, 24.5, 25, 26, 28, 30, 32, 36, 42, 48, 48.5, 49, 50, 52, 54, 56, 60, 66, 72 and 168 hours upto Day 7|The All Subjects – Part B Population. Only those participants available at the specified time points were analyzed.||Ratio||95% Confidence Interval|Median
678446|NCT01597635|Secondary|Measures of Oxygenation Including Level of Positive End Expiratory Pressure (PEEP), Peak Ventilatory Pressures and Plateau Ventilatory Pressures Upto Day 7 (Part B)|Measures of oxygenation included PEEP the pressure in the lungs (alveolar pressure) above atmospheric pressure (the pressure outside of the body) that exists at the end of expiration, peak ventilator pressure highest level of pressure applied to the lungs during inhalation and plateau ventilatory pressure the pressure applied to small airways and alveoli measured during an inspiratory pause on the ventilator. Assessments were performed at 0.5, 1, 2, 4, 6, 8, 12, 18, 24, 24.5, 25, 26, 28, 30, 32, 36, 42, 48, 48.5, 49, 50, 52, 54, 56, 60, 66, 72 and 168 hours upto Day 7. Data has been presented for median along with the 95% credible interval.|0.5, 1, 2, 4, 6, 8, 12, 18, 24, 24.5, 25, 26, 28, 30, 32, 36, 42, 48, 48.5, 49, 50, 52, 54, 56, 60, 66, 72 and 168 hours upto Day 7|The All Subjects – Part B Population. Only those participants available at the specified time points were analyzed.||centimeters of water pressure||90% Confidence Interval|Median
678447|NCT01597635|Secondary|Pharmacodynamic/Biomarker Analysis (Renin-angiotensin System Cascade Biomarkers) to Include Ang II/Ang (1-5) and Ang II/Ang (1-7) Upto Day 5(Part B)|Renin-angiotensin system cascade biomarkers included Ang II/Ang (1-5) and Ang II/Ang (1-7) and). Blood samples for biomarker analyses were collected 0.5 hours, 2 hours, 6 hours, 12 hours, 24 hours, 48 hours, 48.5 hours, 50 hours, 54 hours, 60 hours, 66 hours, 72 hours, 96 hours and 120 hours upto Day 5. Data has been presented for median along with the 95% credible interval.|0.5 hours, 2 hours, 6 hours, 12 hours, 24 hours, 48 hours, 48.5 hours, 50 hours, 54 hours, 60 hours, 66 hours, 72 hours, 96 hours and 120 hours upto Day 5.|The All Subjects – Part B Population. Only those participants available at the specified time points were analyzed.||Ratio||95% Confidence Interval|Median
678448|NCT01597635|Secondary|Pharmacodynamic/Biomarker Analysis (Renin-angiotensin System Cascade Biomarkers) to Include Ang II, Ang (1-7) and Ang (1-5) Upto Day 5(Part B)|Renin-angiotensin system cascade biomarkers included Ang II, Ang (1-7) and Ang (1-5). Blood samples for biomarker analyses were collected 0.5 hours, 2 hours, 6 hours, 12 hours, 24 hours, 48 hours, 48.5 hours, 50 hours, 54 hours, 60 hours, 66 hours, 72 hours, 96 hours and 120 hours upto Day 5. Data has been presented for median along with the 95% credible interval.|0.5 hours, 2 hours, 6 hours, 12 hours, 24 hours, 48 hours, 48.5 hours, 50 hours, 54 hours, 60 hours, 66 hours, 72 hours, 96 hours and 120 hours upto Day 5.|The All Subjects – Part B Population. Only those participants available at the specified time points were analyzed.||picograms per milliliter||95% Confidence Interval|Median
678449|NCT01597635|Secondary|Pharmacodynamic/Biomarker Analysis (Renin-angiotensin System Cascade Biomarkers) to Include Ang II/ Ang (1-7) Upto Day 2 (Part A)|Renin-angiotensin system cascade biomarkers included Ang II/Ang (1-7). Blood samples for biomarker analyses were collected at Pre-dose, 5 minutes, 10 minutes, 2 hours, 6 hours, 10 hours, 12 hours on Day 1 and 0 hours, 1 hour, 12 hours and 24 hours on Day 2.|Pre-dose, 5 minutes, 10 minutes, 2 hours, 6 hours, 10 hours, 12 hours (Day 1) and 0 hours, 1 hour, 12 hours and 24 hours (Day 2).|All Subjects – Part A Population.||Ratio||95% Confidence Interval|Geometric Mean
678450|NCT01597635|Secondary|Pharmacodynamic/Biomarker Analysis (Renin-angiotensin System Cascade Biomarkers) to Include Angiotensin (Ang) II and Ang (1-7) Upto Day 2 (Part A)|Renin-angiotensin system cascade biomarkers included Ang II and Ang (1-7). Blood samples for biomarker analyses were collected at Pre-dose, 5 minutes, 10 minutes, 2 hours, 6 hours, 10 hours, 12 hours (Day 1) and 0 hours, 1 hour, 12 hours and 24 hours on Day 2.|Pre-dose, 5 minutes, 10 minutes, 2 hours, 6 hours, 10 hours, 12 hours (Day 1) and 0 hours, 1 hour, 12 hours and 24 hours (Day 2).|All Subjects – Part A Population||picograms per milliliter||95% Confidence Interval|Geometric Mean
678451|NCT01597635|Secondary|Analysis Pharmacokinetic Parameter Clearance (CL) for GSK2586881 (Part B)|Blood samples for pharmacokinetic analysis of GSK2586881 were collected at Pre-dose, 0 hour, 5 minutes, 10 minutes, 2 hours, 6 hours, 10 hours, 12 hours, 24 hours, 25 hours, 36 hours and 48 hours. CL was defined as the systemic clearance of parent drug. Clearance was calculated for individual participant and geometric mean of the values from all participants was reported.|Pre-dose, 0 hour, 5 minutes, 10 minutes, 2 hours, 6 hours, 10 hours, 12 hours, 24 hours, 25 hours, 36 hours, 48 hours|Pharmacokinetic - Part B Population.||liters per hour||Standard Error|Geometric Mean
678452|NCT01597635|Secondary|Analysis of Pharmacokinetic Parameter Clearance (CL) for GSK2586881 (Part A)|Blood samples for pharmacokinetic analysis of GSK2586881 were collected at Pre-dose, 0 hour, 5 minutes, 10 minutes, 2 hours, 6 hours, 10 hours, 12 hours, 24 hours, 25 hours, 36 hours and 48 hours. CL was defined as the systemic clearance of parent drug. Clearance was calculated for individual participant and geometric mean of the values from all participants was reported.|Pre-dose, 0 hour, 5 minutes, 10 minutes, 2 hours, 6 hours, 10 hours, 12 hours, 24 hours, 25 hours, 36 hours, 48 hours|Pharmacokinetic - Part A Population.||liters per hour||Standard Error|Geometric Mean
678453|NCT01597635|Secondary|Analysis of GSK2586881 Plasma Pharmacokinetic Concentration (Part B)|Blood samples for pharmacokinetic analysis of GSK2586881 were collected Pre-dose, 0.5 Hours, 2 hours, 6 hours, 12 hours (Day 1), 0 hours (Day 2), 0 hours, 0.5 hours, 2 hours, 6 hours, 12 hours, 18 hours and 24 hours (Day 3). Data has been presented for GSK2586881 Plasma Pharmacokinetic Concentration versus time data for Part B.|Pre-dose, 0.5 Hours, 2 hours, 6 hours, 12 hours (Day 1), 0 hours (Day 2), 0 hours, 0.5 hours, 2 hours, 6 hours, 12 hours, 18 hours and 24 hours (Day 3)|The Pharmacokinetic - Part B Population was defined as participants in the All Subjects – Part B population for whom a pharmacokinetic sample was obtained and analyzed and a result reported and received an active dose of GSK2586881. Only those participants with data available at the indicated time points were analyzed.||nanograms per milliliter||Standard Deviation|Mean
678454|NCT01597635|Secondary|Analysis of GSK2586881 Plasma Pharmacokinetic Concentration (Part A)|Blood samples for pharmacokinetic analysis of GSK2586881 were collected Pre-dose, 5 minutes, 10 minutes, 2 hours, 6 hours, 10 hours, 12 hours (Day 1), 0 hours, 1 hour, 12 hours, 24 hours (Day 2). Data has been presented for GSK2586881 Plasma Pharmacokinetic Concentration versus time data for Part A|Pre-dose, 5 minutes, 10 minutes, 2 hours, 6 hours, 10 hours, 12 hours (Day 1), 0 hours, 1 hour, 12 hours, 24 hours (Day 2)|The Pharmacokinetic - Part A Population was defined as participants in the All Subjects – Part A population for whom a pharmacokinetic sample was obtained and analyzed and a result reported and received an active dose of GSK2586881.||nano grams per milliliter||Standard Deviation|Mean
678455|NCT01597635|Primary|Number of Par With AE and Serious Adverse Event (SAE) Assessment Upto Day 7 (Part B)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury.|Up to Day 7|All Subjects – Part B Population.||Participant|||Number
678456|NCT01597635|Primary|Number of Participant With Adverse Event (AE) and Serious Adverse Event (SAE) Assessment Upto Day 7 (Part A)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury.|Up to Day 7|The All Subjects – Part A Population was defined as all participants in Part A who received at least one dose of study medication.||Participants|||Number
678457|NCT01597635|Primary|Clinical Chemistry Parameters Albumin and Total Protein Assessment Upto Day 7 (Part B)|Clinical chemistry parameters included albumin and total protein. Assessments were performed at Pre-dose on Day 1, at 12 hours on Day 3 and at follow-up Day 7.|Up to Day 7|The All Subjects – Part B Population. Only those participants available at the specified time points were analyzed.||grams per liter||Standard Deviation|Mean
678458|NCT01597635|Primary|Clinical Chemistry Parameters Alkaline Phosphatase, Asparatate Amino Transferase, Alanine Amino Transferase, Gamma Glutamyl Transferase Assessment Upto Day 7 (Part B)|Clinical chemistry parameters included alkaline phosphatase, asparatate amino transferase, alanine amino transferase, gamma glutamyl transferase. Assessments were performed at Pre-dose on Day 1, at 12 hours on Day 3 and at follow-up Day 7.|Up to Day 7|The All Subjects – Part B Population. Only those participants available at the specified time points were analyzed.||International units per liter||Standard Deviation|Mean
678459|NCT01597635|Primary|Clinical Chemistry Parameters Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Assessment Upto Day 7 (Part B)|Clinical chemistry parameters included direct bilirubin, total bilirubin, creatinine and uric acid. Assessments were performed at Pre-dose on Day 1, at 12 hours on Day 3 and at follow-up Day 7.|Up to Day 7|The All Subjects – Part B Population. Only those participants available at the specified time points were analyzed.||micromoles per liter||Standard Deviation|Mean
678460|NCT01597635|Primary|Clinical Chemistry Parameters Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen Assessment Upto Day 7 (Part B)|Clinical chemistry parameters included calcium, chloride, carbon dioxide, glucose, potassium, sodium, Urea/Blood urea nitrogen. Assessments were performed at Pre-dose on Day 1, at 12 hours on Day 3 and at follow-up Day 7.|Up to Day 7|The All Subjects – Part B Population. Only those participants available at the specified time points were analyzed.||millimoles per liter||Standard Deviation|Mean
678461|NCT01597635|Primary|Hematology Parameter Hematocrit Assessment Upto Day 7 (Part B)|Hematology parameter included hematocrit. Assessments were performed at Pre-dose on Day 1, at 12 hours on Day 3 and at follow-up Day 7.|Up to Day 7|The All Subjects – Part B Population. Only those participants available at the specified time points were analyzed.||Fraction||Standard Deviation|Mean
678462|NCT01597635|Primary|Hematology Parameter Mean Corpuscle Hemoglobin (MCH) Assessment Upto Day 7 (Part B)|Hematology parameter included MCH. Assessments were performed at Pre-dose on Day 1, at 12 hours on Day 3 and at follow-up Day 7.|Up to Day 7|The All Subjects – Part B Population. Only those participants available at the specified time points were analyzed.||picograms||Standard Deviation|Mean
678463|NCT01597635|Primary|Hematology Parameter Mean Corpuscle Volume (MCV) Assessment Upto Day 7 (Part B)|Hematology parameter included MCV. Assessments were performed at Pre-dose on Day 1, at 12 hours on Day 3 and at follow-up Day 7.|Up to Day 7|The All Subjects – Part B Population. Only those participants available at the specified time points were analyzed.||femtoliters||Standard Deviation|Mean
678464|NCT01597635|Primary|Hematology Parameter Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Assessment Upto Day 7 (Part B)|Hematology parameters included hemoglobin and MCHC. Assessments were performed at Pre-dose on Day 1, at 12 hours on Day 3 and at follow-up Day 7.|Up to Day 7|The All Subjects – Part B Population. Only those participants available at the specified time points were analyzed.||grams per liter||Standard Deviation|Mean
678465|NCT01597635|Primary|Hematology Parameters Red Blood Cell Count and Reticulocyte Count Assessment Upto Day 7 (Part B)|Hematology parameters included red blood cell count and reticulocyte count. Assessments were performed at Pre-dose on Day 1, at 12 hours on Day 3 and at follow-up Day 7.|Up to Day 7|The All Subjects – Part B Population. Only those participants available at the specified time points were analyzed.||trillion cells per liter||Standard Deviation|Mean
678952|NCT01590563|Primary|Efficacy in Preventing Pregnancy|Prevention of pregnancy will be measured. Pregnancy rates are expected to be comparable to current IUDs.|12 months|||Number of pregnancies|||Number
678466|NCT01597635|Primary|Hematology Parameters Basophils, Eosinophil, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count Upto Day 7 (Part B)|Hematology parameters included basophils, eosinophil, lymphocytes, monocytes, total neutrophils, platelet count and white blood cell count. Assessments were performed at Pre-dose on Day 1, at 12 hours on Day 3 and at follow-up Day 7.|Up to Day 7|The All Subjects – Part B Population. Only those participants available at the specified time points were analyzed.||giga per liter||Standard Deviation|Mean
678467|NCT01597635|Primary|Electrocardiogram (ECG) Parameters, Including PR, QRS, QT, and QTCU and RR Intervals Upto Day 7 (Part B)|Single 12-lead ECGs were obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and QTCU and RR intervals. Assessments were performed at Pre-dose on Day 1, at 12 hours on Day 3 and at follow-up Day 7.|Up to Day 7|The All Subjects – Part B Population. Only those participants available at the specified time points were analyzed.||millisecond||Standard Deviation|Mean
678468|NCT01597635|Primary|Diastolic and Systolic Blood Pressure Assessments Upto Day 7 (Part B)|Vital sign included systolic blood pressure and diastolic blood pressure. Assessments were performed at Pre-dose, 0.5 hours, 2 hours, 6 hours and 12 hours on Day 1, 0 hours on Day 2 at 0 hours, 0.5 hours, 2 hours, 6 hours, 12 hours, 18 hours and 24 hours on Day 3 and at follow-up on Day 7.|Up to Day 7|The All Subjects – Part B Population. Only those participants available at the specified time points were analyzed.||Millimeters of merucry||Standard Deviation|Mean
678469|NCT01597635|Primary|Heart Rate Assessments Upto Day 7 (Part B)|Vital sign included heart rate. Assessments were performed at Pre-dose, 0.5 hours, 2 hours, 6 hours and 12 hours on Day 1, 0 hours on Day 2 at 0 hours, 0.5 hours, 2 hours, 6 hours, 12 hours, 18 hours and 24 hours on Day 3 and at follow-up on Day 7.|Up to Day 7|The All Subjects – Part B Population was defined as all participants in Part B who received at least one dose of study medication. Only those participants available at the specified time points were analyzed.||Beats per minute||Standard Deviation|Mean
678470|NCT01597596|Secondary|Change From Baseline in Motor Development Status at Week 52|Motor development status was assessed by the Gross Motor Function Measure - 88 Scale (GMFM-88) total percent scores. GMFM-88 is an 88-item measure to detect gross motor function. It consists of 5 categories: lying and rolling; sitting; crawling and kneeling; standing; walking, running and jumping. Each item was scored on a 4-point Likert scale (0 = cannot do; 1 = initiates [<10% of the task]; 2 = partially completes [10% to <100% of the task]; 3 = task completion). The score for each dimension was expressed as a percentage of the maximum score for that dimension. Total score ranges from 0% to 100%, where higher scores indicate better motor functions.|Baseline, Week 52|Full analysis population. For this endpoint no participants were analyzed in 'Algucosidase Alfa 4000 L material’ arm at Baseline and Week 52. One participant from ‘Algucosidase Alfa 160 L Material’ arm was discontinued from study at Week 31 due to physician’s decision.||percentage of maximum total score||Standard Deviation|Mean
678471|NCT01597596|Secondary|Number of Participants With Invasive Ventilator-Free Survival|Invasive ventilator-free survival was defined as the time during which the participant is alive and not invasively ventilated. Number of Participants with invasive ventilator-free survival were reported.|Up to Week 52|Full analysis population.||participants|||Number
678472|NCT01597596|Secondary|Percentage of Participants With Estimated Probability of Survival||Up to Week 52|Full analysis population.||percentage of participants|||Number
678473|NCT01597596|Primary|Change From Baseline in Cardiac Function at Week 52|Cardiac function was measured by the left ventricular mass Z-score (LVM-Z). Z-Scores indicate the number of standard deviations (SD) from the mean in a normal distribution. A negative change from baseline indicates a decrease and positive change from baseline indicates an increase in LVM Z-score. The normal range is -2 to 2 and greater than 2 may indicate left ventricular hypertrophy.|Baseline, Week 52|Full analysis population defined as all participants who receive at least 1 infusion of alglucosidase alfa. For this endpoint no participants were analyzed in 'Algucosidase Alfa 4000 L material’ arm at Baseline and Week 52. One participant from ‘Algucosidase Alfa 160 L Material’ arm was discontinued from study at Week 31 due to physician’s decision||Z-score||Standard Deviation|Mean
678474|NCT01597492|Primary|Number of Participants With Positive Antibody Responses to at Least One of the 23 Pneumococcal Vaccine Serotypes 4 Weeks Post-vaccination|A positive immune response to at least one pneumococcal serotype is defined as a 2-fold or greater increase from pre-vaccination levels. For unquantifiable pre-vaccination antibody levels, a positive antibody response was considered as a post-vaccination level >=0.6 micrograms (µg)/milliliter (mL). Post-vaccination pneumococcal titers were assessed on Day 28 (Week 4) prior to the first dose of belimumab in the early cohort and on Day 196 (Week 28) prior to the last belimumab dose in the late cohort. Evaluable participants for the early cohort included those who received the vaccination at Day 0 and had titers drawn at Week 4. For the late cohort, evaluable participants received at least 5 of the 7 doses of belimumab up through Week 24, received the vaccination at Week 24, and had titers drawn at Week 28.|Four weeks after vaccination|As-treated Population: all participants who received at least one dose of belimumab. All analyses of vaccine titers were performed on the As-treated Population.||Participants|||Number
678475|NCT01597479|Secondary|Maximum Pain Intensity, Rescue Analgesia, Nausea and Vomiting Incidence, Use of Ondansetron for NVPO, Efectiveness of Ondansetron|Number of participants with Maximum pain intensity NVS > 3; Rescue analgesia; Nausea and Vomiting incidence; use of ondansetron for NVPO; Ondansetron being effective (number of participants for whom ondansetron was effective to stop NVPO).|Up to 48 hours|Patients undergoing ambulatory thumb resection arthroplasty||participants|||Number
678476|NCT01597479|Primary|Proportion of Patients Who Experienced Moderate to Severe Pain During First and Second Postoperative Day|Pain scores assessed using pain numerical visual scale (NVS) of 0-10 (o= no pain and 10= worst pain imaginable). We defined mild pain (NVS 0-3); moderate pain (NVS 4-6) and severe pain (NVS 7-10).The analysis of this variable at the end of the study will confirm or not the effectiveness of dPNBs for management of postoperative pain after TRA.|Up to 48 hours|Patients undergoing ambulatory thumb resection arthroplasty (TRA)||percentage of patients|||Number
678477|NCT01597440|Secondary|Number of Participants With Adverse Events|Safety is measured by tracking and detailing the number and type of adverse events and their severity based on the CTCAE.|Start of episode through 7 days or discharge (if earlier)|||Participants|||Number
678478|NCT01597440|Primary|Neurodevelopment|Neurodevelopmental outcome as measured by Cognitive Composite (Bayley III), Motor Composite (Bayley III) and Functional Status Scale and safety of NCG treatment as measured by adverse events and laboratory blood tests|30 months|The study was closed prematurely. There is no analysis population.|||||
678479|NCT01597245|Secondary|Percentage of Participants With Anti-Ixekizumab Antibodies|Percentage of participants with treatment-emergent positive anti-ixekizumab antibodies was summarized by treatment group. Percentage was calculated based on the # of evaluable participants and was calculated by number of participants with treatment-emergent positive anti-ixekizumab antibodies / number of evaluable participants * 100%.|Baseline to Week 12|All randomized participants who received at least 1 dose of study treatment and had evaluable data.||percentage of participants|||Number
678480|NCT01597245|Secondary|Percentage of Participants Achieving Palmoplantar PASI (PPASI) of ≥50% (PPASI50), ≥75% (PPASI75) or 100% (PPASI100) Improvement|The Palmoplantar PASI is a composite score derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement, ranging from 0 to 72. The PPASI was only assessed if participants have palmoplantar psoriasis at baseline. Participants achieving PPASI50, PPASI75 or PASI100 were defined as having an improvement of at least 50%, 75%, or of 100%, respectively, in the PPASI scores compared to baseline.|Week 12|All randomized participants analyzed according to the treatment to which they are assigned; and who had palmoplantar Ps involvement at baseline. Participants who did not meet clinical response criteria or have missing data will be considered non-responders.||percentage of participants|||Number
678481|NCT01597245|Secondary|Change From Baseline in Patient's Global Assessment (PatGA) of Disease Severity|"The Patient's Global Assessment of Disease Severity is a single-item patient reported outcome measure on which participants are asked to rate by circling a number on a 0 to 5 NRS the severity of their psoriasis today from 0 (Clear) = no psoriasis to 5 (Severe) = the worst their psoriasis has ever been. LS mean change from baseline in patient's global assessment of disease severity score was calculated using (MMRM) with baseline score as a covariate, treatment, pooled center, visit, and treatment-by-visit interaction as fixed effects."|Baseline, 12 weeks|All randomized participants analyzed according to the treatment to which they are assigned, and had baseline and at least 1 post baseline PatGA measurement.||units on a scale||Standard Error|Least Squares Mean
678482|NCT01597245|Secondary|Change From Baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) and Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores|The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped into the PCS and MCS scores. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. In this study, the SF-36 acute version was used, which has a 1 week recall period. LS mean change from baseline in SF-36 score was calculated using the ANCOVA model with treatment, pooled center and baseline SF-36 score.|Baseline, Week 12|All randomized participants analyzed according to the treatment to which they are assigned, and had baseline and at least 1 post baseline SF-36 measurement. Missing data was imputed by last observation carried forward ( LOCF ).||units on a scale||Standard Error|Least Squares Mean
678483|NCT01597245|Secondary|Change From Baseline in All Scores of the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO)|The (WPAI-PSO) is a 6-item instrument used to assess the impact of psoriasis on productivity impairment within the past 7 days and has four domains, namely, absenteeism, presenteeism (reduced productivity while at work), an overall work impairment score, and impairment in daily activities performed outside of work. Four scores are derived as percentages: absenteeism, presenteeism, overall work impairment (absenteeism and presenteeism), and impairment in activities performed outside of work. Percentage is calculated as each score * 100 and ranges from 0 to 100; greater scores indicate greater impairment. LS mean change from baseline in each WPAI-PSO score was calculated using the (ANCOVA) model with treatment, pooled center and baseline WPAI value.|Baseline, Week 12|All randomized participants analyzed according to the treatment to which they are assigned, and had baseline and at least 1 post baseline WPAI-PSO measurement. Missing data was imputed by last observation carried forward ( LOCF ).||units on a scale||Standard Error|Least Squares Mean
678484|NCT01597245|Secondary|Change From Baseline in Quick Inventory of Depressive Symptomatology-Self Report 16 Items (QIDS-SR16) Total Score|The QIDS-SR16 is a self-administered, 16-item instrument in which a participant is asked to consider each statement as it relates to the way they have felt for the past 7 days. There is a 4-point scale for each item ranging from 0 (best) to 3 (worst). The 16 items are scored to give 9 individual depression domains (sad mood, concentration, self-criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance [initial, middle and late insomnia or hypersomnia], decrease/increase in appetite/weight, and psychomotor agitation/retardation), which are summed to give a single score ranging from 0 to 27, with higher scores denoting greater symptom severity. LS mean change from baseline in total QIDS-SR16 score was calculated using the analysis of covariance (ANCOVA) model with treatment, pooled center and baseline QIDS total score.|Baseline, Week 12|All randomized participants analyzed according to the treatment to which they are assigned, and had baseline and at least 1 post baseline QIDS-SR16 measurement. Missing data was imputed by last observation carried forward (LOCF).||units on a scale||Standard Error|Least Squares Mean
678485|NCT01597245|Secondary|Change From Baseline in Percent of Body Surface Area (BSA) Involvement of Psoriasis|The percentage involvement of psoriasis on each participant's body surface area was assessed by the investigator on a continuous scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participant's hand including palm, fingers and thumb. LS mean change from baseline in BSA was calculated using MMRM with baseline BSA as a covariate, treatment, pooled center, visit, and treatment-by-visit interaction as fixed effects.|Baseline, Week 12|All randomized participants analyzed according to the treatment to which they are assigned; and had at least 1 post-baseline BSA measurement.||units on a scale||Standard Error|Least Squares Mean
678493|NCT01597245|Secondary|Percentage of Participants Achieving an sPGA (0) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: [sPGA])|The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant’s Ps was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe).|Week 12|All randomized participants analyzed according to the treatment to which they were assigned. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for Non-Responder Imputation (NRI) analysis.||percentage of participants|||Number
678486|NCT01597245|Secondary|Change From Baseline Psoriasis Scalp Severity Index (PSSI) Score|The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (<10%) to 6 (90%-100%) with a total scores range from 0 (less severity) to 72 (more severity), with lower scores indicating less severity. LS mean change from baseline in PSSI score was calculated using MMRM with baseline score as a covariate, treatment, pooled center, visit, and treatment-by-visit interaction as fixed effects.|Baseline, Week 12|All randomized participants analyzed according to the treatment to which they are assigned; and had scalp Ps involvement at baseline and at least 1 post-baseline PSSI measurement. Missing data was imputed by last observation carried forward (LOCF).||units on a scale||Standard Error|Least Squares Mean
678487|NCT01597245|Secondary|Change From Baseline in Nail Psoriasis Severity Index (NAPSI)|The NAPSI scale is used to evaluate the severity of fingernail bed Ps and fingernail matrix Ps. The fingernail bed and fingernail matrix are each divided into quadrants. Each fingernail is given a score for fingernail bed Ps and fingernail matrix Ps, each with scores of 0 (none) to 4 (Ps in all 4 quadrants), depending on the presence (score of 1) or absence (score of 0) of Ps in each quadrant of the fingernail bed or matrix. The NAPSI score of a fingernail is the sum of scores from each quadrant of the fingernail bed and fingernail matrix (maximum of 8). The total NAPSI score equals the sum of all fingernails and ranges from 0 to 80 with higher scores indicating more severe Ps. LS mean change from baseline in NAPSI score was calculated using MMRM with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.|Baseline, Week 12|All randomized participants analyzed according to the treatment to which they are assigned; and had fingernail Ps involvement at baseline and at least 1 post-baseline NAPSI measurement.||units on a scale||Standard Error|Least Squares Mean
678488|NCT01597245|Secondary|Change From Baseline in Dermatology-Specific Quality of Life Index (DLQI) Total Score (Quality of Life and Outcome Assessments. Measures: Participant Reported Outcomes [PRO])|"DLQI is a participant-administered, 10-question, validated, quality-of-life questionnaire that covers 6 domains, including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include 0 (not at all), 1 (a little), 2 (a lot), and 3 (very much); and not relevant and unanswered responses were scored as 0. Total scores range from 0 to 30, with higher score indicating greater quality of life impairment. A 5-point change from baseline is considered clinically relevant. Least Squares (LS) Mean change from baseline was calculated using mixed model repeated measures (MMRM) with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects."|Baseline, Week 12|All randomized participants analyzed according to the treatment to which they are assigned and who had baseline and at least 1 post-baseline DLQI measurement.||units on a scale||Standard Error|Least Squares Mean
678489|NCT01597245|Secondary|Percentage of Participants With Itching Severity (Itch Numeric Rating Scale [NRI]) Score ≥4 Point Reduction From Baseline|"The Itch Numeric Rating Scale (NRS) is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing no itch and 10 representing worst itch imaginable. The number and percentage of participants achieving an Itch NRS ≥4 point reduction from baseline were presented by treatment group for participants who had a baseline Itch NRS ≥4. Describes worst level of itching in past 24 hours."|Baseline, Week 12|All randomized participants analyzed according to the treatment to which they are assigned and had Itch NRS ≥4 at baseline. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for NRI analysis.||percentage of participants|||Number
678490|NCT01597245|Secondary|Percentage of Participants Maintaining an sPGA (0,1) From Week 12 After Re-randomization at Start of Maintenance Dosing Period to Week 60|The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's Ps was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe).|Week 60|All randomized participants who had sPGA score of (0,1) at Week 12, were re-randomized at Week 12 and received at least 1 dose of study treatment in the Maintenance Dosing Period. Participants who did not meet the clinical response criteria or had missing data at Week 60 were considered non-responders for Non-Responder Imputation (NRI) analysis.||Percentage of participants|||Number
678491|NCT01597245|Secondary|Percentage of Participants Achieving PASI 100% (PASI100)|The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor (head [0.1], upper limbs [0.2], trunk [0.3], lower limbs [0.4]). Overall scores range from 0 (no Ps) to 72 (the most severe disease). Participants achieving PASI100 were defined as having an improvement of 100% in the PASI score compared to baseline.|Week 12|All randomized participants analyzed according to the treatment to which they are assigned. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for NRI analysis.||percentage of participants|||Number
678492|NCT01597245|Secondary|Percentage of Participants Achieving PASI 90% (PASI90) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: [PASI])|The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor (head [0.1], upper limbs [0.2], trunk [0.3], lower limbs [0.4]). Overall scores range from 0 (no Ps) to 72 (the most severe disease). Participants achieving PASI90 were defined as having an improvement of ≥90% in the PASI score compared to baseline.|Week 12|All randomized participants analyzed according to the treatment to which they were assigned. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for Non-Responder Imputation (NRI) analysis.||percentage of participants|||Number
678515|NCT01596842|Secondary|Change of FGF-23 Levels||12 weeks||||||
678494|NCT01597245|Primary|Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) ≥75% (PASI75) Improvement (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: Psoriasis Area and Severity Index [PASI])|The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor (head [0.1], upper limbs [0.2], trunk [0.3], lower limbs [0.4]). Overall scores range from 0 (no Ps) to 72 (the most severe disease). Participants achieving PASI75 were defined as having an improvement of ≥75% in the PASI score compared to baseline.|Week 12|All randomized participants analyzed according to the treatment to which they were assigned. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for Non-Responder Imputation (NRI) analysis.||percentage of participants|||Number
678495|NCT01597245|Primary|Percentage of Participants With a Static Physician Global Assessment (sPGA) of (0,1) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: Static Physician Global Assessment [sPGA])|The sPGA is the physician's determination of the participant's Psoriasis (Ps) lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's Ps was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of “0” or “1” with at least a 2-point improvement from baseline.|Week 12|All randomized participants analyzed according to the treatment to which they were assigned. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for Non-Responder Imputation (NRI) analysis.||percentage of participants|||Number
678496|NCT01597141|Secondary|Functioning|Global Assessment of Functioning scale (GAF) at 24 months to assess functioning in symptom, role and social relationships. Global Assessment of Functioning is a widely used scale based on a Likert-keyed score assigned by an interviewer or clinician, based on a scale of 0-100, with 100 being the highest level of functioning.|24 months|15 participants in the FACT arm and 16 participants in the Enhanced Standard Treatment arm were not assessed, having discontinued participation in the study.||units on GAF scale||Standard Deviation|Mean
678497|NCT01597141|Primary|Onset of Psychosis|Onset of psychosis is defined as an event--a new psychotic episode with loss of insight, meeting a score criterion of 6 for one month on the Scale of the Prodromal Syndrome (SOPS), in which full psychosis is defined as havng one score or 6, on a scale of 0 to 6, with 0 representing no psychotic symptoms, and 6 representing full psychosis on any of 5 dimensions of psychosis. The assessemnt is based on the Structrued Interview for the Prodromal Syndrome (SIPS), w widely used instrument for assessing risk of psychosis in adolescents and young adults.|From date of randomization until the date of first documented onset of psychosis, assessed up to 60 months|||percentage of sample converting|||Number
678498|NCT01597128|Primary|Change in SF12 Mental Component Score Between Pre-operation and 12 Months Post-operation|Change in SF12 Mental Component Score from pre-operation to 12 months post-operation: Scores were normalized with 50 equal to the national norm and 40 equal to one standard deviation below the norm; An increase is better.|12 months|Patients with 12 month completion of the SF12||Normalized scores||Standard Deviation|Mean
678499|NCT01597128|Primary|Change in SF12 Physical Component Score Between Pre-operation and 12 Months Post-operation|Change in SF12 Physical Component Score from pre-operation to 12 months post-operation: Scores were normalized with 50 equal to the national norm and 40 equal to one standard deviation below the norm, so a 12 month difference of 10 would equal a 1 standard deviation change; An increase is better.|12 months|Patients with 12 month completion of the SF12||Normalized scores||Standard Deviation|Mean
678500|NCT01597128|Primary|Wound Occurrence: Superficial Wound Infection|Superficial wound infection|12 months|||percent of patients|||Number
678501|NCT01597128|Primary|Wound Occurrence: Wound Dehiscence||12 Months|||percentage of patients|||Number
678502|NCT01597128|Primary|Wound Occurrence: Wound Cellulitis||12 Months|||percentage of patients|||Number
678503|NCT01597128|Primary|Wound Occurrence: Wound Seroma||12 Months|||percentage of patients|||Number
678504|NCT01597128|Primary|Wound Occurrence: Wound Abscess||12 Months|||percentage of patients|||Number
678505|NCT01597128|Primary|Wound Occurrence: Deep Wound Infection||12 Months|||percentage of patients|||Number
678506|NCT01597128|Primary|Wound Occurrence|superficial or deep wound infection, abscess, seroma, cellulitis, necrosis, hematoma or wound dehiscence.|12 months|||percentage of patients|||Number
678507|NCT01597128|Primary|Hernia Recurrence|Recurrence of hernia based on physical exam and /or CT scan.|12 months|||percentage of patients|||Number
678508|NCT01597050|Primary|Decrease in the Total Combined Erythema and Scaling Score (Minimum of 0 and Maximum of 65) of All Treated Lesions.|Percentage of patients who achieved at least a 50% decrease from baseline in the total combined Erythema and Scaling score of all treated lesions at Week 4. A decrease is an improvement in measurement of erythema and scaling of the lesions.|Up to Week 4|Per-protocol population all patients who had no major protocol deviations and were present at all scheduled visits up to and including Week 4.||percentage of subjects|||Number
678509|NCT01596972|Secondary|Patient Satisfaction With Each Follow-up Method|"Patient satisfaction with each follow-up method was assessed with the following survey questions:
How satisfied are you with [name of follow-up method]? (very satisfied, satisfied, neutral, unsatisfied, very unsatisfied)"|1 week|||participants|||Number
678510|NCT01596972|Secondary|Patient Compliance With Each Follow-up Method||2 weeks|||participants|||Number
678511|NCT01596972|Primary|Number of Women in Each Group Who Require a Return Visit to the Clinic for a Serum hCG Measurement, Ultrasound or Clinical Examination at One Week to Confirm Complete Evacuation||1 week|The number of participants analyzed in the serum hCG arm were the number of participants who started in this arm minus the number who were discontinued from the study per MD decision (total N in analysis was therefore 17).||participants|||Number
678512|NCT01596842|Secondary|Changes of Phosphate Binder Doses||4 weeks, 8 weeks and 12 weeks||||||
678513|NCT01596842|Secondary|Changes of Erythropoietin Doses||4 weeks, 8 weeks and 12 weeks||||||
678514|NCT01596842|Secondary|Changes of Phosphorous Levels||4 weeks, 8 weeks and 12 weeks||||||
678521|NCT01596582|Other Pre-specified|Concordance Between Patient Preferences for a Screening Tests Other Than Colonoscopy and Test Ordered for High Versus Low Risk Patients|Test-specific concordance between patient preference for a screening test other than colonoscopy (fecal occult blood testing, flexible sigmoidoscopy, double-contrast barium enema, CT colonography and stool DNA) and test ordered for high versus low risk patients. It is defined as the number of patients who had their preferred test ordered.|3 months|||Participants|||Count of Participants
678522|NCT01596582|Other Pre-specified|Concordance Between Patient Preference for Colonoscopy and Test Ordered for High Versus Low Risk Patients|Test-specific concordance between patient preference for colonoscopy and test ordered for high versus low risk patients. It is defined as the number of patients who had their preferred test ordered.|3 months|||Participants|||Count of Participants
678523|NCT01596582|Other Pre-specified|Concordance Between Patient Preferences for Screening Tests Other Than Colonoscopy and Test Ordered|Test-specific concordance between patient preference for a screening test other than colonoscopy (fecal occult blood testing, flexible sigmoidoscopy, double-contrast barium enema, CT colonography and stool DNA) and test ordered for standard care versus risk assessment arms. It is defined as the number of patients who had their preferred test ordered.|3 months|||Participants|||Count of Participants
678524|NCT01596582|Other Pre-specified|Concordance Between Patient Preference for Colonoscopy and Test Ordered|Test-specific concordance between patient preference for colonoscopy and test ordered for standard care versus risk assessment groups. It is defined as the number of patients who had their preferred test ordered.|3 months|||Participants|||Count of Participants
678525|NCT01596582|Secondary|Provider Satisfaction|Provider satisfaction was assessed based on responses to a 3-item pretest administered prior to commencement of the study and the same 3-item posttest. The 3 items assessed to the extent to which providers felt that personalized risk assessment would be useful for: (1) selecting an appropriate screening test for their average risk patients [test selection]; (2) reduce time to decide on an appropriate screening modality [save time]; and (3) make them more receptive to patient preferences and possibly order a screening test other than colonoscopy [receptive to patient preferences]. Responses were assigned a point value ranging from 5= “strongly agree” and 1 = “strongly disagree”.|Two years|The difference in the number of providers reflect provider attrition during the 2-year study period.||units on a scale||Standard Deviation|Mean
678526|NCT01596582|Secondary|Screening Test Completion|Test completion rates were tracked using BMC’s electronic medical record, which captures results for all endoscopic procedures, imaging studies, and stool blood tests.|6 months|||Participants|||Count of Participants
678527|NCT01596582|Secondary|Screening Intentions|Screening intentions were assessed on the posttest. Patients were asked how sure they were that they would complete the screening test that got scheduled Scores ranged from 5 = ‘‘completely’’ to 1 = ‘‘not at all sure.’’ Data was missing for 11 patients in the concordant group and 6 patients in the discordant group.|3 months|||units on a scale||Standard Deviation|Mean
678528|NCT01596582|Secondary|Satisfaction With Decision-making Process (SDMP)|SDMP was assessed on the posttest using the validated 12-item Satisfaction with the Decision-Making Process scale. Individual items are assigned a point value ranging from 1 for ‘‘strongly disagree’’ (or ‘‘poor’’) to 5 for ‘‘strongly agree’’ (or ‘‘excellent’’). A cumulative score is then calculated based on the summed response scores for each item (maximum score = 60). Data was missing for 11 patients in the concordant group and 6 patients in the discordant group|One month|The subgroup of patients who had their preferred test ordered, regardless of study arm or risk-category. The subgroup of patients who had a non-preferred test ordered, regardless of study arm or risk-category.||units on a scale||Standard Deviation|Mean
678529|NCT01596582|Secondary|Concordance Between Patient Preference and Test Ordered for High vs. Low Risk Patients|Concordance between patient preference and test ordered for high versus low risk patients. It is defined as the number of patients who had their preferred test ordered.|3 months|Patients with cumulative ACNI scores of 5 to 12 were classified as intermediate/high risk (hereafter referred to as high risk), with a mean ACN rate of 8.3% (95% CI, 7.1% - 29.6%). Patients with cumulative scores of less than 5 were classified as low risk, with a mean ACN rate of 3.1% (95% confidence interval [CI], 2.4% - 24.1%).||Participants|||Count of Participants
678530|NCT01596582|Primary|Concordance Between Patient Preference and Test Ordered|Concordance is a measure of the agreement between the patient's test preference and actual test ordered for standard care vs. risk assessment patients. It is defined as the number of patients who had their preferred test ordered.|3 months|||Participants|||Count of Participants
678531|NCT01596504|Secondary|Change From Baseline to Day 56 in the Cumulative Score Mean on the Appetite Perception Using a Visual Analogue Scale After Standardized Solid Breakfast|Visual Analogue Scale, 100 mm in length with words anchored at each end, expressing the most positive (100 mm) and the most negative rating (0 mm), was used to assess hunger, satiety, fullness and prospective food consumption. Responses were measured as distance from the left end of the line to the mark. Mean change from baseline was calculated for each parameter separately.|0.5 (8:00 clock time, prior to standardized breakfast), 1.5, 2.5, 3.5, 4.5, 5.5 hours on Day -3; 0 (prior to standardized breakfast), 1.5, 2.5, 3.5, 4.5, 5.5 hours post study drug administration on Day 56|PD population. Number of participants analyzed=participants with appetite perception assessment at specified time-points.||mm||Standard Deviation|Mean
678532|NCT01596504|Secondary|Change From Baseline to Day 57 in Waist Circumference||0.5 hours prior to standardized breakfast on Day -1 (Baseline); 0.5 hours prior to IMP administration on Day 57|PD population. Number of participants analyzed = participants with waist circumference assessment at specified time-points.||cm||Standard Deviation|Mean
678533|NCT01596504|Secondary|Change From Baseline to Day 57 in Body Weight||0.5 hours prior to standardized breakfast on Day -1 (Baseline); 0.5 hours prior to study drug administration on Day 57|PD population. Number of participants analyzed = participants with body weight assessment at specified time-points.||kg||Standard Error|Least Squares Mean
678557|NCT01596062|Primary|Saturation Rate of CD25 Antigen Saturation by Basiliximab|CD25 saturation is the percentage of T cells expressing CD25|Day 0, Day 1, Day 4, Day 6, Day 14, Day 21, Day 28, Day 42, Day 56 and Day 84 (Week 12) post-transplantation|PK/PD population: Patients included in the ITT population for whom at least one blood sample for PK/PD analyses was collected. This population is the reference population for the PK and PD analyses.||percentage of T cells||Standard Deviation|Mean
678534|NCT01596504|Secondary|Change From Baseline to Day 57/58 in 24-Hour Mean Systolic Blood Pressure and Diastolic Blood Pressure|The baseline value was the 24-hour means on Day -2/-1 determined as overall, night and day-time mean. Measurements were made every 15 minutes from 07:00 to 23:00 (day-time) and every 30 minutes from 23:00 to 07:00 (night-time) at baseline and at Day 57/58. Measurements were obtained after 10 minutes in the supine resting position.|Every 15 minutes from 07:00 clock time to 23:00 clock time (day-time) and every 30 minutes from 23:00 clock time to 07:00 clock time (night-time) on Day -2/ -1 (Baseline) and Day 57/58|PD population. Number of participants analyzed = participants with blood pressure assessment at specified time-points.||mmHg||Standard Deviation|Mean
678535|NCT01596504|Secondary|Change From Baseline to Day 57/58 in 24-Hour Mean Heart Rate|The baseline value was the 24-hour mean on Day -2/-1 determined as overall, night and daytime mean. Measurements were made every 15 minutes from 07:00 to 23:00 (daytime) and every 30 minutes from 23:00 to 07:00 (night-time) at baseline and Day 57/58. Measurements were obtained after 10 minutes in the supine resting position.|Every 15 minutes from 07:00 clock time to 23:00 clock time (day-time) and every 30 minutes from 23:00 clock time to 07:00 clock time (night-time) on Day -2/-1 (Baseline) and Day 57/58|PD population. Number of participants analyzed = participants with heart rate assessment at specified time-points.||beats per minute||Standard Error|Least Squares Mean
678536|NCT01596504|Secondary|Change From Baseline to Day 55 in Gastric Emptying Coefficient|Gastric emptying was measured using 13C-octanoic acid breath test by isotope-selective non-dispersive infrared spectrometry. Gastric emptying coefficient was derived from a mathematical formula that describes the gastric emptying rate and gives an overall index of gastric emptying.|0 (7:30 clock time, prior to standardized breakfast), 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 3.5, 4, 4.5, 5, 5.5 hours on Day -4 (baseline) and on Day 55|PD population. Number of participants analyzed = participants with gastric emptying at specified time-points.||coefficient (unit-less)||Standard Deviation|Mean
678537|NCT01596504|Secondary|Change From Baseline to Day 55 in Gastric Emptying Half Life (t1/2)|Gastric emptying was measured using 13C-octanoic acid breath test by isotope-selective non-dispersive infrared spectrometry.|0 (prior to standardized breakfast), 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 3.5, 4, 4.5, 5, 5.5 hours on Day -4 (baseline) and on Day 55|PD population. Number of participants analyzed=participants with gastric emptying assessment at specified time-points.||minutes (min)||Standard Error|Least Squares Mean
678538|NCT01596504|Secondary|Change From Baseline to Day 56 in Average Daily Insulin Glargine Dose||Day -7 (Baseline), Day 56|PD population. Number of participants analyzed=participants with insulin glargine dose assessment at specified time-points.||units||Standard Deviation|Mean
678539|NCT01596504|Secondary|Change From Baseline to Day 56 in HbA1c|HbA1C was assessed using the high performance liquid chromatography method.|Pre-dose (Hour 0) on Day 1 (Baseline) and Day 56|Number of participants analyzed = participants with HbA1c assessment at specified time-points.||percentage of HbA1c||Standard Error|Least Squares Mean
678540|NCT01596504|Secondary|Change From Baseline to Day 56 in Corrected Glucagon AUC From Time 0.5 Hours to 5.5 Hours|Glucagon was assessed using the radioimmunoassay. The range of the method was 4.7 to 150 picomole per litre (pmol/L). Measurement was done on Day -3 (Baseline) and Day 56 as the maximum change in glucagon from time of breakfast start (time: 0.5 hours) until 5 hours later (time: 5.5 hours) subtracted from pre-meal plasma concentration.|0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours on Day -3 (baseline); 0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours post study drug administration on Day 56|PD population. Number of participants analyzed = participants with glucagon assessment at specified time-points.||h*ng/L||Standard Error|Least Squares Mean
678541|NCT01596504|Secondary|Change From Baseline to Day 56 in Corrected C-Peptide AUC From Time 0.5 Hours to 5.5 Hours|C-peptide was assessed using the Electro Chemiluminescence Immuno Assay.The range of the method was 0.2 to 25 nanogram per millilitre (ng/mL) and the LOD was 0.07 ng/mL. Measurement was done on Day -3 (Baseline) and Day 56 as the maximum change in C-peptide from time of breakfast start (time: 0.5 hours) until 5 hours later (time: 5.5 hours) subtracted from pre-meal plasma concentration.|0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours on Day-3 (baseline); 0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours post study drug administration on Day 56|PD population. Number of participants analyzed = participants with C-peptide assessment at specified time-points.||h*nmol/L||Standard Error|Least Squares Mean
678542|NCT01596504|Secondary|Change From Baseline to Day 56 in Average 7-Point Self-Monitored Plasma Glucose (SMPG)|Seven-point SMPG (before breakfast, 2 hours post breakfast, before lunch, 2 hours post lunch, before dinner, 2 hours post dinner, and at bedtime) was measured using Freestyle Precision glucometer and average of the 7 measurements was calculated.|Before breakfast, 2 hours post breakfast, before lunch, 2 hours post lunch, before dinner, 2 hours post dinner, and at bedtime on Day -3 (Baseline) and on Day 56|PD population. Number of participants analyzed = participants with 7 point SMPG assessment at specified time-points.||mmol/L||Standard Deviation|Mean
678543|NCT01596504|Secondary|Change From Baseline to Day 56 in Fasting Plasma Glucose (FPG)|Plasma glucose was assessed using the Gluco-quant Glucose/hexokinase assay. The range of the method was 3 to 1000 mg/dL with 1 mg/dL as LOD. The value of FPG on Day -3 was the baseline.|0.5 hour (prior to standardized breakfast) on Day -3; 0.5 hour (prior to standardized breakfast) on Day 56|PD population. Number of participants analyzed = participants with plasma glucose assessment at specified time-points.||mmol/L||Standard Error|Least Squares Mean
678544|NCT01596504|Secondary|Change From Baseline to Day 56 in PPG Excursion|Plasma glucose was assessed using the Gluco-quant Glucose/hexokinase assay. The range of the method was 3 to 1000 mg/dL with 1 mg/dL as LOD. PPG excursion was determined on Day -3 (Baseline) and Day 56 as the maximum change in PPG from time of breakfast start (time: 0.5 hours) until 5 hours later (time: 5.5 hours) subtracted from pre-meal plasma concentration.|0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours on Day -3 (baseline); 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours post study drug administration on Day 56|PD population. Number of participants analyzed = participants with plasma glucose assessment at specified time-points.||mmol/L||Standard Error|Least Squares Mean
678545|NCT01596504|Secondary|Number of Participants With 2-Hour Post-prandial Plasma Glucose (PPG) <7.77 (mmol/L) at Day 56|Plasma glucose was assessed using the Gluco-quant Glucose/hexokinase assay. The range of the method was 3 to 1000 mg/dL with 1 mg/dL as LOD. The 2-hour PPG test measured blood glucose 2 hours after start of a standardised breakfast.|Day 56|PD population. Number of participants analyzed = participants with plasma glucose assessment at specified time-points.||participants|||Number
678546|NCT01596504|Secondary|Change From Baseline to Day 56 in Plasma Glucose Corrected AUC From Time 0.5 Hours to 5.5 Hours|Plasma glucose was assessed using the Gluco-quant Glucose/hexokinase assay. The range of the method was 3 to 1000 mg/dL with 1 mg/dL as limit of detection (LOD). Calculation of the AUC was made on Day -3 (baseline) and on Day 56 using the linear trapezoidal rule from time of breakfast start (30 minutes after study drug administration [time: 0.5 hours]) to 5 hours after breakfast start (time: 5.5 hours) and corrected by subtracting pre-breakfast plasma glucose concentration (time: 0.5 hours).|0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours on Day -3 (baseline); 0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours post study drug administration on Day 56|PD population. Number of participants analyzed = participants with plasma glucose assessment at specified time-points.||h*mmol/L||Standard Error|Least Squares Mean
678547|NCT01596504|Primary|Change From Baseline to Day 56 in Plasma Glucose Corrected Area Under The Plasma Concentration-Time Curve (AUC) From Time 0.5 Hours to 4.5 Hours|Plasma glucose was assessed using the Gluco-quant Glucose/hexokinase assay. The range of the method was 3 to 1000 milligram per decilitre (mg/dL) with 1 mg/dL as limit of detection (LOD). Calculation of the AUC was made on Day -3 (baseline) and on Day 56 using the linear trapezoidal rule from time of breakfast start (30 minutes after study drug administration [time: 0.5 hours]) to 4 hours after breakfast start (time: 4.5 hours) and corrected by subtracting pre-breakfast plasma glucose concentration (time: 0.5 hours).|0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5 hours on Day -3 (baseline); 0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5 hours post study drug administration on Day 56|Pharmacodynamic (PD) population defined as all randomized participants, who received at least one dose of lixisenatide 20 μg, liraglutide 1.2 mg or liraglutide 1.8 mg, and had both a baseline assessment and at least one post-baseline assessment of any primary or secondary PD variables, irrespective of compliance with study protocol and procedures.||h*mmol/L||Standard Error|Least Squares Mean
678548|NCT01596231|Primary|Drinking Behaviors|A variety of measures describing the drinking behavior will be analyzed with appropriate parametric tests (t-test, analysis of variance): number of beers consumed, weight and volume consumed, sip analysis (number, interlude), and latency (time to open first and subsequent drinks).|Study end|||beers consumed||Standard Deviation|Mean
678549|NCT01596088|Primary|Adverse Events|Number of participants experienced adverse events|4 weeks|||participants|||Number
678550|NCT01596062|Secondary|Estimated Glomerular Filtration Rate (eGFR) at Day 8 and Week 24|(MDRDa formula) with imputation by last observation carried forward (LOCF)|Day 8, Week 24|Intent to treat (ITT) population: All randomized patients having received at least one Simulect® injection and who had been transplanted. This population is the reference population for the efficacy analyses.||mL/min/1.73m^2||Standard Deviation|Mean
678551|NCT01596062|Secondary|Percentage of Participants With of Treatment Failures|Treatment failure was defined either as a BPAR, a graft loss, a death or a loss to follow-up. An extended treatment failure was also defined including treated borderline lesions, BPAR, graft loss, death or loss to follow-up. Treated borderline lesions were considered as acute rejection by investigators and DMC experts.|Day 84 (Week 12), Week 24|Intent to treat (ITT) population: All randomized patients having received at least one Simulect® injection and who had been transplanted. This population is the reference population for the efficacy analyses.||Percentage of participants|||Number
678552|NCT01596062|Secondary|Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity|Antibody mediated acute rejection: C4d deposition, presence of circulating antidonor antibody, morphologic evidence of acute tissue injury such as acute tubular necrosis-like minimal inflammation or capillary and/or glomerular inflammation and/or thromboses or arterial inflammation. Cellular acute rejection: acute T-cell mediated rejection Type IA: Significant interstitial infiltration (> 25% of parenchyma) and foci of moderate tubulitis (> 4 mononuclear cells/tubular cross section or group of 10 tubular cells) Type IB: Significant interstitial infiltration (> 25% of parenchyma) and foci of severe tubulitis (> 10 mononuclear cells/tubular cross section or group of 10 tubular cells) Type IIA: Mild to moderate intimal arteritis. Type IIB: Severe intimal arteritis comprising > 25% of the lumenal area. Type III: Transmural (full vessel wall thickness) arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells (with accompanying lymphocytic inflammation).|Day 84 (Week 12), Week 24 post-transplantation|Intent to treat (ITT) population: All randomized patients having received at least one Simulect® injection and who had been transplanted. This population is the reference population for the efficacy analyses.||Percentage of participants|||Number
678553|NCT01596062|Secondary|Percentage of Participants With of Biopsy Proven Acute Rejection (BPAR)|BPAR is one of the components of treatment failure. One assessment of efficacy was BPAR. Renal graft biopsies were performed and the renal tissue was examined to determine if there was acute rejection of the renal transplant.|Day 84 (Week 12), Week 24 post-transplantation|Intent to treat (ITT) population: All randomized patients having received at least one Simulect® injection and who had been transplanted. This population is the reference population for the efficacy analyses.||Percentage of participants|||Number
678554|NCT01596062|Secondary|Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells|Cell counts of various subpopulations of T, B and NK lymphocytes (CD3, CD4, CD8, CD19 and CD56) (flow cytometry).|Day 0, Day 6, Day 42, Day 84 (Week 12)|PK/PD population: Patients included in the ITT population for whom at least one blood sample for PK/PD analyses was collected. This population is the reference population for the PK and PD analyses.||10^9 cells/L||Standard Deviation|Mean
678555|NCT01596062|Secondary|Percentage of T-cells That Bind Basiliximab to CD25 Receptors|This is the percentage of T cells binding basiliximab at all timepoints.|Day 0, Day 1, Day 4, Day 6, Day 14, Day 21, Day 28, Day 42, Day 56 and Day 84 (Week 12) post-transplantation|PK/PD population: Patients included in the ITT population for whom at least one blood sample for PK/PD analyses was collected. This population is the reference population for the PK and PD analyses.||Percentage of T cells||Standard Deviation|Mean
678556|NCT01596062|Secondary|AUC of Basiliximab Binding to CD25 Receptors From Day 0 to Day 84|Mean AUC was calculated only for patients who received two Simulect injections.|Day 84 (Week 12) post-transplantation|PK/PD population: Patients included in the ITT population for whom at least one blood sample for PK/PD analyses was collected. This population is the reference population for the PK and PD analyses.||Weeks * Percentage of T cells||Standard Deviation|Mean
683533|NCT01525849|Secondary|Revision Rate|Number of participants requiring repeat sinus procedures|1-year|All treated participants with 1-year follow-up (or a revision surgery before 1-year follow-up if no 1-year follow-up).||Participants|||Count of Participants
678558|NCT01596062|Primary|Area Under the Curve (AUC) of CD25 Saturation by Basiliximab From Day 0 to Day 84|CD25 saturation is the percentage of T cells expressing CD25. Mean AUC of CD25 was calculated only for patients who received two Simulect® injections.|Day 84 (Week 12) after transplantation|PK/PD population: Patients included in the ITT population for whom at least one blood sample for PK/PD analyses was collected. This population is the reference population for the PK and PD analyses.||Weeks * Percentage of saturated CD25||Standard Deviation|Mean
678559|NCT01595854|Secondary|Number of Participants With Drug Related Adverse Events|The number of participants with drug related adverse events|From screening until the end-of-study examination|Treated set||participants|||Number
678560|NCT01595854|Primary|Total Dabigatran: Maximum Measured Concentration (Cmax)|Maximum measured concentration of total dabigatran in plasma, per period.|-1/-0.5, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours|Pharmacokinetic (PK) set defined as all subjects of Part 3 who received at least 1 dose of trial medication and provided at least 1 observation for at least 1 PK endpoint without important protocol violations relevant to the evaluation of bioavailability.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
678561|NCT01595854|Primary|Total Dabigatran (Dabi): Area Under the Curve 0 to Infinity (AUC0-∞)|Area under the concentration-time curve of the analyte in plasma, over the time interval from 0 extrapolated to infinity, of dabigatran.|-1/-0.5, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours|Pharmacokinetic (PK) set defined as all subjects of Part 3 who received at least 1 dose of trial medication and provided at least 1 observation for at least 1 PK endpoint without important protocol violations relevant to the evaluation of bioavailability.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
678562|NCT01595438|Secondary|Plasma Concentrations for Avibactam Between 300 to 360 Minutes After Dose(PK Analysis Set)|Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.|Between 300 to 360 minutes after dose|PK analysis set (avibactam between 300 to 360 minutes after dose)||NG/ML||Full Range|Geometric Mean
678563|NCT01595438|Secondary|Plasma Concentrations for Avibactam Between 30 to 90 Minutes After Dose(PK Analysis Set)|Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.|Between 30 to 90 minutes after dose|PK analysis set (avibactam between 30 to 90 minutes after dose)||NG/ML||Full Range|Geometric Mean
678564|NCT01595438|Secondary|Plasma Concentrations for Avibactam Within 15 Minutes Before/After Dose (PK Analysis Set)|Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.|within 15 minutes before/after dose|PK analysis set (avibactam within 15 minutes before/after dose)||NG/ML||Full Range|Geometric Mean
678565|NCT01595438|Secondary|Plasma Concentrations for Ceftazidime Between 300 to 360 Minutes After Dose(PK Analysis Set)|Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.|Between 300 to 360 minutes after dose|PK analysis set (ceftazidime between 300 to 360 minutes after dose)||NG/ML||Full Range|Geometric Mean
678566|NCT01595438|Secondary|Plasma Concentrations for Ceftazidime Between 30 to 90 Minutes After Dose(PK Analysis Set)|Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.|Between 30 to 90 minutes after dose|PK analysis set (ceftazidime between 30 to 90 minutes after dose)||NG/ML||Full Range|Geometric Mean
678567|NCT01595438|Secondary|Plasma Concentrations for Ceftazidime Within 15 Minutes Before/After Dose (PK Analysis Set)|Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.|within 15 minutes before/after dose|PK analysis set (ceftazidime within 15 minutes before/after dose)||NG/ML||Full Range|Geometric Mean
678568|NCT01595438|Secondary|Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)|Per pathogen microbiological response at TOC by Doripenem MIC for baseline pathogen in the ME at TOC analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization|Microbiological evaluable analysis set at TOC (ME at TOC)||Participant|||Number
678569|NCT01595438|Secondary|Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)|Per pathogen microbiological response at TOC by Doripenem MIC for baseline pathogen in the Extended ME at TOC analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization|Extended microbiological evaluable analysis set at TOC (EME at TOC)||Participant|||Number
678570|NCT01595438|Secondary|Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)|Per pathogen microbiological response at TOC by Doripenem MIC for baseline pathogen in the mMITT analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization|Microbiological modified intent to treat analysis set (mMITT)||Participant|||Number
678571|NCT01595438|Secondary|Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)|Per pathogen microbiological response at TOC by CAZ-AVI MIC for baseline pathogen in the ME at TOC analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization|Microbiological evaluable analysis set at TOC (ME at TOC)||Participant|||Number
678572|NCT01595438|Secondary|Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)|Per pathogen microbiological response at TOC by CAZ-AVI MIC for baseline pathogen in the Extended ME at TOC analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization|Extended microbiological evaluable analysis set at TOC (EME at TOC)||Participant|||Number
678573|NCT01595438|Secondary|Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)|Per pathogen microbiological response at TOC by CAZ-AVI MIC for baseline pathogen in the mMITT analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization|Microbiological modified intent to treat analysis set (mMITT)||Participant|||Number
678574|NCT01595438|Secondary|Per-pathogen Microbiological Response at LFU for Blood Only (ME at LFU Analysis Set)|Number of favorable per-pathogen microbiological responses at the LFU visit in the ME at LFU analysis set for blood only|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Microbiological evaluable analysis set at LFU (ME at LFU)||Participant|||Number
678575|NCT01595438|Secondary|Per-pathogen Microbiological Response at TOC for Blood Only (ME at TOC Analysis Set)|Number of favorable per-pathogen microbiological responses at the TOC visit in the ME at TOC analysis set for blood only|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological evaluable analysis set at TOC (ME at TOC)||Participant|||Number
678953|NCT01590563|Primary|Rates of Uterine Perforation|Uterine perforation is an established risk of IUD deployment which may cause certain health hazards. It is anticipated that the IUB(tm), through its form and deployment pattern, will reduce this risk.|During installation|||Number of cases|||Number
678576|NCT01595438|Secondary|Per-pathogen Microbiological Response at EOT (IV) for Blood Only (ME at EOT (IV) Analysis Set)|Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the ME at EOT (IV) analysis set for blood only|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Microbiological evaluable analysis set at EOT (IV) (ME at EOT (IV))||Participant|||Number
678577|NCT01595438|Secondary|Per-pathogen Microbiological Response at LFU for Blood Only (Extended ME at LFU Analysis Set)|Number of favorable per-pathogen microbiological responses at the LFU visit in the Extended ME at LFU analysis set for blood only|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Extended microbiological evaluable analysis set at LFU (EME at LFU)||Participant|||Number
678578|NCT01595438|Secondary|Per-pathogen Microbiological Response at TOC for Blood Only (Extended ME at TOC Analysis Set)|Number of favorable per-pathogen microbiological responses at the TOC visit in the Extended ME at TOC analysis set for blood only|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Extended microbiological evaluable analysis set at TOC (EME at TOC)||Participant|||Number
678579|NCT01595438|Secondary|Per-pathogen Microbiological Response at EOT (IV) for Blood Only (Extended ME at EOT (IV) Analysis Set)|Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the Extended ME at EOT (IV) analysis set for blood only|At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Extended microbiological evaluable analysis set at EOT (IV) (EME at EOT (IV))||Participant|||Number
678580|NCT01595438|Secondary|Per-pathogen Microbiological Response at LFU for Blood Only (mMITT Analysis Set)|Number of favorable per-pathogen microbiological responses at the LFU visit in the mMITT analysis set for blood only|At LFU visit. LFU visit is 45 to 52 days from Randomization|Microbiological modified intent to treat analysis set (mMITT)||Participant|||Number
678581|NCT01595438|Secondary|Per-pathogen Microbiological Response at TOC for Blood Only (mMITT Analysis Set)|Number of favorable per-pathogen microbiological responses at the TOC visit in the mMITT analysis set for blood only|At TOC visit. TOC visit is 21 to 25 days from Randomization|Microbiological modified intent to treat analysis set (mMITT)||Participant|||Number
678582|NCT01595438|Secondary|Per-pathogen Microbiological Response at EOT (IV) for Blood Only (mMITT Analysis Set)|Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the mMITT analysis set for blood only|At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Microbiological modified intent to treat analysis set (mMITT)||Participant|||Number
678583|NCT01595438|Secondary|Per-pathogen Microbiological Response at LFU for Baseline Pathogen (ME at LFU Analysis Set)|Number of favorable per-pathogen microbiological responses at the LFU visit in the ME at LFU analysis set|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Microbiological evaluable analysis set at LFU (ME at LFU)||Participant|||Number
678584|NCT01595438|Secondary|Per-pathogen Microbiological Response at TOC for Baseline Pathogen (ME at TOC Analysis Set)|Number of favorable per-pathogen microbiological responses at the TOC visit in the ME at TOC analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological evaluable analysis set at TOC (ME at TOC)||Participant|||Number
678585|NCT01595438|Secondary|Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (ME at EOT (IV) Analysis Set)|Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the ME at EOT (IV) analysis set|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Microbiological evaluable analysis set at EOT (IV) (ME at EOT (IV))||Participant|||Number
678586|NCT01595438|Secondary|Per-pathogen Microbiological Response at LFU for Baseline Pathogen (Extended ME at LFU Analysis Set)|Number of favorable per-pathogen microbiological responses at the LFU visit in the Extended ME at LFU analysis set|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Extended microbiological evaluable analysis set at LFU (EME at LFU)||Participant|||Number
678587|NCT01595438|Secondary|Per-pathogen Microbiological Response at TOC for Baseline Pathogen (Extended ME at TOC Analysis Set)|Number of favorable per-pathogen microbiological responses at the TOC visit in the Extended ME at TOC analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Extended microbiological evaluable analysis set at TOC (EME at TOC)||Participant|||Number
678588|NCT01595438|Secondary|Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (Extended ME at EOT (IV) Analysis Set)|Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the Extended ME at EOT (IV) analysis set|At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Extended microbiological evaluable analysis set at EOT (IV) (EME at EOT (IV))||Participant|||Number
678589|NCT01595438|Secondary|Per-pathogen Microbiological Response at LFU for Baseline Pathogen (mMITT Analysis Set)|Number of favorable per-pathogen microbiological responses at the LFU visit in the mMITT analysis set|At LFU visit. LFU visit is 45 to 52 days from Randomization|Microbiological modified intent to treat analysis set (mMITT)||Participant|||Number
678590|NCT01595438|Secondary|Per-pathogen Microbiological Response at TOC for Baseline Pathogen (mMITT Analysis Set)|Number of favorable per-pathogen microbiological responses at the TOC visit in the mMITT analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization|Microbiological modified intent to treat analysis set (mMITT)||Participant|||Number
678591|NCT01595438|Secondary|Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (mMITT Analysis Set)|Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the mMITT analysis set|At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Microbiological modified intent to treat analysis set (mMITT)||Participant|||Number
678592|NCT01595438|Secondary|Time to First Defervescence While on IV Study Therapy (CE at TOC Analysis Set)|Time to first defervescence while on IV study therapy in patients in the CE at TOC analysis set who have fever at study entry.|Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.|Clinically evaluable analysis set at TOC(CE at TOC)||Participants|||Number
679085|NCT01588158|Secondary|PSEQ|The pain self efficacy questionnaire measures a patient's belief about his/her ability to complete a task despite his/her pain. The scale range is from 0-60, where 60 represents higher self-efficacy beliefs.|1 day|||units on a scale||Standard Deviation|Mean
678593|NCT01595438|Secondary|Time to First Defervescence While on IV Study Therapy (Extended ME at TOC Analysis Set)|Time to first defervescence while on IV study therapy in patients in the Extended ME at TOC analysis set who have fever at study entry.|Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.|Extended microbiological evaluable analysis set at TOC(Extended ME at TOC)||Participants|||Number
678594|NCT01595438|Secondary|Time to First Defervescence While on IV Study Therapy (ME at TOC Analysis Set)|Time to first defervescence while on IV study therapy in patients in the ME at TOC analysis set who have fever at study entry.|Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.|Microbiological evaluable analysis set at TOC(ME at TOC)||Participants|||Number
678595|NCT01595438|Secondary|Time to First Defervescence While on IV Study Therapy (mMITT Analysis Set)|Time to first defervescence while on IV study therapy in patients in the mMITT analysis set who have fever at study entry.|Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.|Microbiological modified intent to treat analysis set (mMITT)||Participants|||Number
678596|NCT01595438|Secondary|Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set)|Favorable per-patient microbiological response at the TOC visit for patients infected with a ceftazidime resistant pathogen in the Extended ME at TOC analysis set.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Extended microbiological evaluable analysis set at TOC(Extended ME at TOC)||Participants|||Number
678597|NCT01595438|Secondary|Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set)|Favorable per-patient microbiological response at the TOC visit for patients infected with a ceftazidime resistant pathogen in the ME at TOC analysis set.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological evaluable analysis set at TOC(ME at TOC)||Participants|||Number
678598|NCT01595438|Secondary|Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set)|Favorable per-patient microbiological response at the TOC visit for patients infected with a ceftazidime resistant pathogen in the mMITT analysis set.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological modified intent to treat analysis set (mMITT)||Participants|||Number
678599|NCT01595438|Secondary|Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set)|Clinical cure at the TOC visit for patients infected with a ceftazidime resistant pathogen in the Extended ME at TOC analysis set. Includes patients infected by at least one ceftazidime-resistant Gram-negative pathogen.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Extended microbiological evaluable analysis set at TOC(Extended ME at TOC)||Participants|||Number
678600|NCT01595438|Secondary|Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set)|Clinical cure at the TOC visit for patients infected with a ceftazidime resistant pathogen in the ME at TOC analysis set. Includes patients infected by at least one ceftazidime-resistant Gram-negative pathogen.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological evaluable analysis set at TOC(ME at TOC)||Participants|||Number
678601|NCT01595438|Secondary|Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set)|Clinical cure at the TOC visit for patients infected with a ceftazidime resistant pathogen in the mMITT analysis set. Includes patients infected by at least one ceftazidime-resistant Gram-negative pathogen.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological modified intent to treat analysis set (mMITT)||Participants|||Number
678602|NCT01595438|Secondary|Investigator Determined Clinical Response at LFU (CE at LFU Analysis Set)|Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Clinically evaluable analysis set at LFU (CE at LFU)||Participants|||Number
678603|NCT01595438|Secondary|Investigator Determined Clinical Response at TOC (CE at TOC Analysis Set)|Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Clinically evaluable analysis set at TOC (CE at TOC)||Participants|||Number
678604|NCT01595438|Secondary|Investigator Determined Clinical Response at EOT (IV) (CE at EOT (IV) Analysis Set)|Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Clinically evaluable analysis set at EOT (IV) (CE at EOT (IV))||Participants|||Number
678605|NCT01595438|Secondary|Investigator Determined Clinical Response at LFU (Extended ME at LFU Analysis Set)|Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Extended microbiological evaluable analysis set at LFU (Extended ME at LFU)||Participants|||Number
678606|NCT01595438|Secondary|Investigator Determined Clinical Response at TOC (Extended ME at TOC Analysis Set)|Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Extended microbiological evaluable analysis set at TOC (Extended ME at TOC)||Participants|||Number
678607|NCT01595438|Secondary|Investigator Determined Clinical Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set)|Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Extended microbiological evaluable analysis set at EOT (IV) (Extended ME at EOT (IV))||Participants|||Number
678608|NCT01595438|Secondary|Investigator Determined Clinical Response at LFU (ME at LFU Analysis Set)|Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Microbiological evaluable analysis set at LFU (ME at LFU)||Participants|||Number
678609|NCT01595438|Secondary|Investigator Determined Clinical Response at TOC (ME at TOC Analysis Set)|Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological evaluable analysis set at TOC (ME at TOC )||Participants|||Number
678610|NCT01595438|Secondary|Investigator Determined Clinical Response at EOT (IV) (ME at EOT (IV) Analysis Set)|Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Microbiological evaluable analysis set at EOT (IV) (ME at EOT (IV))||Participants|||Number
678611|NCT01595438|Secondary|Investigator Determined Clinical Response at LFU (mMITT Analysis Set)|Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Microbiological modified intent to treat analysis set (mMITT)||Participants|||Number
678612|NCT01595438|Secondary|Investigator Determined Clinical Response at TOC (mMITT Analysis Set)|Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological modified intent to treat analysis set (mMITT)||Participants|||Number
678613|NCT01595438|Secondary|Investigator Determined Clinical Response at EOT (IV) (mMITT Analysis Set)|Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Microbiological modified intent to treat analysis set (mMITT)||Participants|||Number
678614|NCT01595438|Secondary|Per-patient Microbiological Response at LFU (Extended ME at LFU Analysis Set)|Number of patients with a favorable per patient microbiological response at LFU|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Extended microbiological evaluable analysis set at LFU (Extended ME at LFU)||Participants|||Number
678615|NCT01595438|Secondary|Per-patient Microbiological Response at TOC (Extended ME at TOC Analysis Set)|Number of patients with a favorable per patient microbiological response at TOC|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Extended microbiological evaluable analysis set at TOC (Extended ME at TOC)||Participants|||Number
678616|NCT01595438|Secondary|Per-patient Microbiological Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set)|Number of patients with a favorable per-patient microbiological response at EOT (IV)|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Extended microbiological evaluable analysis set at EOT (IV) (EME at EOT (IV))||Participants|||Number
678617|NCT01595438|Secondary|Per-patient Microbiological Response at LFU (ME at LFU Analysis Set)|Number of patients with a favorable per patient microbiological response at LFU|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Microbiological evaluable analysis set at LFU (ME at LFU)||Participants|||Number
678618|NCT01595438|Secondary|Per-patient Microbiological Response at TOC (ME at TOC Analysis Set)|Number of patients with a favorable per patient microbiological response at TOC|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological evaluable analysis set at TOC (ME at TOC)||Participants|||Number
678619|NCT01595438|Secondary|Per-patient Microbiological Response at EOT (IV) (ME at EOT (IV) Analysis Set)|Number of patients with a favorable per-patient microbiological response at EOT (IV)|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Microbiological evaluable analysis set at EOT (IV) (ME at EOT (IV))||Participants|||Number
678620|NCT01595438|Secondary|Per-patient Microbiological Response at LFU (mMITT Analysis Set)|Number of patients with a favorable per patient microbiological response at LFU|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Microbiological modified intent to treat analysis set (mMITT)||Participants|||Number
678621|NCT01595438|Secondary|Per-patient Microbiological Response at EOT (IV) (mMITT Analysis Set)|Number of patients with a favorable per-patient microbiological response at EOT (IV)|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Microbiological modified intent to treat analysis set (mMITT)||Participants|||Number
683534|NCT01525849|Primary|Debridements|Number of postoperative debridements per participant|1-year|All treated participants||debridements per participant||Standard Deviation|Mean
678622|NCT01595438|Primary|Per-patient Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test|Number of patients with a favorable per patient microbiological response at TOC. The primary efficacy outcome variable for ROW is the proportion of patients with a favorable per-patient microbiological response at the TOC visit in the mMITT analysis set.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological modified intent to treat analysis set (mMITT)||Participants|||Number
678623|NCT01595438|Primary|Combined Patient-reported Symptomatic and Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test|Number of patients with both a favorable per patient microbiological response and symptomatic resolution (or return to premorbid state) of all UTI-specific symptoms (frequency/urgency/dysuria/suprapubic pain/flank pain) based on the patient-reported symptom assessment response at the TOC visit in the mMITT analysis set. The sponsor will conclude noninferiority if the lower limit of the 95% CI of difference (corresponding to a 97.5% 1-sided lower bound) is greater than -12.5% for both FDA coprimary outcome variables (symptomatic resolution at day 5 or favorable combined response at test of cure (TOC)).|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological modified intent to treat analysis set (mMITT)||Participants|||Number
678624|NCT01595438|Primary|Patient-reported Symptomatic Response at Day 5 (mMITT Analysis Set): Non-inferiority Hypothesis Test|Number of patients with symptomatic resolution (or return to premorbid state) of UTI-specific symptoms except flank pain (frequency/urgency/dysuria/suprapubic pain) with resolution of or improvement in flank pain based on the patient-reported symptom assessment response at the Day 5 visit in the mMITT analysis set. The sponsor will conclude noninferiority if the lower limit of the 95% CI of difference (corresponding to a 97.5% 1-sided lower bound) is greater than -12.5% for both FDA coprimary outcome variables (symptomatic resolution at day 5 or favorable combined response at test of cure (TOC)).|At Day 5 visit. Day 5 visit is based on 24 hour periods from the first dose date and time.|Microbiological modified intent to treat analysis set (mMITT)||Participants|||Number
678625|NCT01595386|Secondary|ACTH Stimulation Test|AdrenoCorticoTropic Hormone stimulation test will be performed at least 24 hours pre-bypass and immediately after successful discontinuation of bypass and compared. These outcomes will be used as a secondary outcome.|24 hours prebypass and 0 hours post-bypass|||microg/dL||Inter-Quartile Range|Median
678626|NCT01595386|Secondary|Mortality|Subject mortality will in the CICU will be used as a secondary outcome.|Duration of CICU stay, approximately 1 week|||percentage of patients|||Number
678627|NCT01595386|Secondary|CICU Length of Stay|CICU length of stay will be calculated from the time the subject is admitted to the CICU post-op until they are discharged from the unit. This will be used as a secondary outcome.|approximately 1 week|||hours||Inter-Quartile Range|Median
678628|NCT01595386|Secondary|Time Until First Extubation|Respiratory values such as duration of intubation will be used as a secondary outcome.|Until discharge from hospital, approximately 2 weeks|||hours||Inter-Quartile Range|Median
678629|NCT01595386|Secondary|Changes in Baseline Arterial-venous Oxygen Saturation Difference|Respiratory values such as changes in baseline arterial-venous oxygen saturation difference at admission to the pediatric cardiac intensive care unit will be used as a secondary outcome.|admit to the CICU|||percentage of arterial-venous saturation||Inter-Quartile Range|Median
678630|NCT01595386|Secondary|Fluid Balance|Hemodynamic variable such as total fluid balance within the first 48 hours post-op will be used as a secondary outcome. Fluid balance is a calculation of the overall fluid status for a given time period. The total input (fluid, medications, etc) that are given to a patient during a given time frame (24 hours) minus the total output (urine, stool, drainage, etc. ) that comes out of a patient during a given time frame.|1st 48 hours post-op|||mL/kg||Inter-Quartile Range|Median
678631|NCT01595386|Secondary|Average Inotrope Score|Average inotrope score over first 48 hours after Cardiac Intensive Care Unit admission was used as a secondary outcome. Inotrope Score is calculated based on the dose of inotropes currently infusing at a given time points. The formula for calculation is as follows: Epinephrine/Norepinephrine (mcg/kg/min) dose x100, plus Dopamine/Dobutamine (mcg/kg/min) dose x 1, plus Neosynephrine (mcg/kg/min) dose x10, plus Vasopressin (units/kg/hr) [(dose x60)/10,000] = Inotrope Score. Our institution does not include Milrinone in our inotrope score calculation because every patient receives a continuous infusion in the immediate post-operative period. The higher the inotrope score the more cardiac support the patient is requiring or the worse their cardiac function is becoming.|first 48 hours post-op|||Inotrope Score||Inter-Quartile Range|Median
678632|NCT01595386|Secondary|Changes in Baseline Inflammatory Mediators|Changes in pre-op inflammatory mediators will be assessed at 0, 4, 12, 24 and 48 hours post bypass and used as a secondary outcome.|0, 4,12, 24, and 48 hours post bypass|||pg/mL||Inter-Quartile Range|Median
678633|NCT01595386|Secondary|Hospital Length of Stay|The average length of hospital stay from the time the subject is admitted to the CICU post-op until they are discharged will be used as a secondary outcome.|Admit to CICU till hospital discharge, approximately 3 weeks|||days||Inter-Quartile Range|Median
678634|NCT01595386|Secondary|Mean Number of Days Subjects Alive and Ventilator Free|Respiratory variables include such as alive, ventilator free days at 28 days post-op will be used as secondary outcome. The mean number of days subjects were live and ventilator free up to the 28 days after surgery.|up to 28 days post op|||days||Inter-Quartile Range|Median
678635|NCT01595386|Primary|Incidence of Low Cardiac Output Syndrome (LCOS)|Low Cardiac Output Syndrome (LCOS) within the first 48 hours after post-operative admission to the Pediatric Cardiac Intensive Care Unit was used as the primary outcome. This was defined as a double in inotropic support from post-operative admit, requiring Extracorporeal Membrane Oxygenation (ECMO) support, receiving Cardiopulmonary Resuscitation, or death.|first 48 hours after cardiac intensive care unit (CICU) admission post-op|||percentage of patients|||Number
678636|NCT01595282|Secondary|Pain Scores 15 Minutes Post-procedure|21-point 0 to 100 scale, where 0 = no pain and 100 = worst possible pain (in increments of five)|Fifteen minutes after the procedure|||units on a scale||Standard Deviation|Mean
678637|NCT01595282|Secondary|Pain Scores Immediately After Cervical Dilation|21-point 0 to 100 scale where 0 = no pain and 100 = worst possible pain (in increments of five)|Immediately (within 1 minute) after cervical dilation prior to the introduction of the suction cannula|||units on a scale||Standard Deviation|Mean
679005|NCT01589510|Secondary|Physician Assessment of Tolerability on a 4-Point Scale|Physician assessment of tolerability was assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented.|Week 14|All patients with data for this outcome measure||Patients|||Number
678638|NCT01595282|Primary|Immediate Post-procedure Pain Score|The primary endpoint is subjects' immediate post-procedure pain score on a 21-point 0 to 100 scale, 0 = no pain and 100 = worst possible pain (in increments of five). This scale has been previously validated and used for research purposes, including for pain research evaluating suction curettage elsewhere and at our institution (Jensen 1986, Williamson 2004, Allen 2009).|Immediately (within 1 minute) after suction and speculum removal|||units on a scale||Standard Deviation|Mean
678639|NCT01594970|Other Pre-specified|Change From Baseline in Hyperemia Severity in the Study Eye|Hyperemia is the engorgement of the blood vessels (redness) of the eye. Hyperemia was graded in the study eye on a 5 point scale where 0=None (Normal), 0.5=Trace (Trace reddish pink with no more than slight perilimbal injection), 1=Mild (Mild flush reddish color), 2=Moderate (Bright red color), and 3=Severe (Deep, bright, diffuse redness). 'Lower' categories refer to grades 0, 0.5 and 1, and 'higher' categories refer to grades 2 and 3. Change in hyperemia severity was classified as improved, no change or worsened based on the change in the hyperemia grading category from higher to lower, no change in category or lower to higher, respectively. The numbers of participants in each category are presented.|Baseline, Week 12|Intent to Treat: all treated subjects with data at this time point||Participants|||Number
678640|NCT01594970|Secondary|Overall Percent Change From Baseline in IOP|IOP is a measure of the fluid pressure inside the eye. A negative number change response indicates a reduction in IOP (improvement).|Baseline, Week 6, Week 12|Intent to Treat: all treated subjects with data at this time point||Percent Change||Standard Deviation|Mean
678641|NCT01594970|Secondary|Change From Baseline in Intraocular Pressure (IOP)|IOP is a measure of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement).|Baseline, Week 6, Week 12|Intent to Treat: all treated subjects||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
678642|NCT01594970|Primary|Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale|Hyperemia is the engorgement of the blood vessels (redness) of the eye. Hyperemia is graded in the study eye on a 5 point scale where 0=None (Normal), 0.5=Trace (Trace reddish pink with no more than slight perilimbal injection), 1=Mild (Mild flush reddish color), 2=Moderate (Bright red color), and 3=Severe (Deep, bright, diffuse redness). The numbers of participants in each severity grade are presented.|Week 12|Intent to Treat: all treated subjects with data at this time point||Participants|||Number
678643|NCT01594762|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAE)|The number of participants with TEAEs, including Serious TEAEs, are reported|28 days|Safety||Participants|||Count of Participants
678644|NCT01594762|Secondary|Number of Participants With Microbiological Response|The numbers of participants with Microbiological Response, defined are eradication of all baseline pathogens, are reported.|28 days|Intent-To-Treat Microbiological (positive for baseline pathogens)||Participants|||Count of Participants
678645|NCT01594762|Primary|Number of Participants With Clinical Response|The numbers of participants with Clinical Response, defined as resolution of infection, are reported.|28 days|Intent-To-Treat||Participants|||Count of Participants
678646|NCT01594749|Secondary|Percentage of Participants With No Vomiting From 0 to 120 Hours After Initiation of MEC|No Vomiting was defined as no emetic (vomiting) episodes, including no vomiting and no retching or dry heaves (attempts to vomit that are not productive of stomach contents), regardless of use of rescue medication.|0 to 120 hours after initiation of MEC|The ITT population consisted of all randomized participants who received ≥1 dose of study drug within the assigned treatment regimen. One participant in the Fosaprepitant Regimen was excluded from the ITT population due to missing source documentation. One participant in the Control Regimen was treated with fosaprepitant in error.||Percentage of participants|||Number
678647|NCT01594749|Secondary|Percentage of Participants With Complete Response From 0 to 24 Hours After Initiation of MEC|A Complete Response was defined as no vomiting and no use of rescue medication.|0 to 24 hours after initiation of MEC|The ITT population consisted of all randomized participants who received ≥1 dose of study drug within the assigned treatment regimen. One participant in the Fosaprepitant Regimen was excluded from the ITT population due to missing source documentation. One participant in the Control Regimen was treated with fosaprepitant in error.||Percentage of Participants|||Number
678648|NCT01594749|Secondary|Percentage of Participants With Complete Response From 0 to 120 Hours After Initiation of MEC|A Complete Response was defined as no vomiting and no use of rescue medication.|0 to 120 hours after initiation of MEC|The ITT population consisted of all randomized participants who received ≥1 dose of study drug within the assigned treatment regimen. One participant in the Fosaprepitant Regimen was excluded from the ITT population due to missing source documentation. One participant in the Control Regimen was treated with fosaprepitant in error.||Percentage of Participants|||Number
678649|NCT01594749|Primary|Percentage of Participants With Severe Infusion-site Reactions|The percentages of participants with severe infusion-site reactions, including severe site pain, or severe site redness (erythema) or severe site hardness (induration) are presented.|Day 1 through Day 17, inclusive|The Safety population consisted of all randomized participants who received study drug as treated.||Percentage of Participants|||Number
678650|NCT01594749|Primary|Percentage of Participants With Infusion-site Thrombophlebitis|The percentages of participants with infusion-site thrombophlebitis are presented. Thrombophlebitis was defined as a condition affecting a superficial vein used for an IV infusion, associated with red color, hardness upon palpation, and the presence of a tender cord and possible fever.|Day 1 through Day 17, inclusive|The Safety population consisted of all randomized participants who received study drug as treated.||Percentage of Participants|||Number
678651|NCT01594749|Primary|Percentage of Participants With Complete Response From 25 to 120 Hours After Initiation of Moderately Emetogenic Chemotherapy (MEC)|A Complete Response was defined as no vomiting and no use of rescue medication.|25 to 120 hours after initiation of MEC|The ITT population consisted of all randomized participants who received ≥1 dose of study drug within the assigned treatment regimen. One participant in the Fosaprepitant Regimen was excluded from the ITT population due to missing source documentation. One participant in the Control Regimen was treated with fosaprepitant in error.||Percentage of Participants|||Number
678707|NCT01593670|Secondary|Number of Patients Who Became Transfusion Independent||4-6 Months Post Start of Cycle 1|7 of the 9 patients were not evaluable for this outcome measure - 5 went on to stem cell transplant and 2 died before reaching the 4-6 month post start of cycle 1 milestone.This left 2 evaluable patients for the outcome measure, and thus this endpoint is not informative due to lack of evaluable patients.||Participants|||Count of Participants
678652|NCT01594515|Secondary|AUC0-infinity of BI 1015550|Area under the concentration-time curve in plasma over the time interval from 0 extrapolated to infinity|−0.5hour before dosing and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing|The pharmacokinetic analysis set (PKS) included all subjects in the TS who provided at least 1 evaluable observation for a PK endpoint. A subject was considered to be evaluable if he provided sufficient data, did not vomit at or before 2x median tmax and completed the trial without any iPV relevant to the PK evaluation.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
678653|NCT01594515|Secondary|Cmax of BI 1015550|Maximum measured concentration of the analyte in plasma.|−0.5hour before dosing and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing|The pharmacokinetic analysis set (PKS) included all subjects in the TS who provided at least 1 evaluable observation for a PK endpoint. A subject was considered to be evaluable if he provided sufficient data, did not vomit at or before 2x median tmax and completed the trial without any iPV relevant to the PK evaluation.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
678654|NCT01594515|Primary|Number (%) of Subjects With Clinically Relevant Abnormalities in Physical Examinations|Percentage of subjects with clinically relevant abnormalities in physical examinations.|From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.|The treated set (TS) included all subjects who were dispensed study medication and were documented to have taken at least 1 dose of the investigational treatment.||Percentage of Participants|||Number
678655|NCT01594515|Primary|Number (%) of Subjects With Clinically Relevant Abnormalities in Tolerability|Percentage of subjects with clinically relevant abnormalities in tolerability assessed by the investigator.|From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.|The treated set (TS) included all subjects who were dispensed study medication and were documented to have taken at least 1 dose of the investigational treatment.||Percentage of Participants|||Number
678656|NCT01594515|Primary|Number (%) of Subjects With Clinically Relevant Abnormalities in 12-lead ECGs|Percentage of subjects with clinically relevant abnormalities in 12-lead ECGs.|Day -21 to -2, -1 hour, 0.5h, 1h, 2h, 4h, 8h, 10h, 24h, 48h, 72h and study examination(within 5 to 7 days after last PK sampling).|The treated set (TS) included all subjects who were dispensed study medication and were documented to have taken at least 1 dose of the investigational treatment.||Percentage of Participants|||Number
678657|NCT01594515|Primary|Number (%) of Subjects With Clinically Relevant Abnormalities in Vital Signs|Percentage of subjects with clinically relevant abnormalities in vital signs (blood pressure, pulse rate, respiratory rate, oral body temperature, orthostasis test).|Day -21 to -2, -1 hour, 0.5h, 1h, 2h, 4h, 8h, 10h, 24h, 48h, 72h and study examination(within 5 to 7 days after last PK sampling).|The treated set (TS) included all subjects who were dispensed study medication and were documented to have taken at least 1 dose of the investigational treatment.||Percentage of Participants|||Number
678658|NCT01594515|Primary|Number (%) of Subjects With Clinically Relevant Abnormalities in Clinical Laboratory Tests|Percentage of subjects with clinically relevant abnormalities in clinical laboratory tests (haematology, clinical chemistry, haemoccult® test, and urinalysis).|Day -21 to -2, upto -72 hours, 4h, 24h, 48h, 72h and study examination(within 5 to 7 days after last PK sampling).|The treated set (TS) included all subjects who were dispensed study medication and were documented to have taken at least 1 dose of the investigational treatment.||Percentage of Participants|||Number
678659|NCT01594515|Primary|Number (%) of Subjects With Drug Related Adverse Events|Percentage of subjects with drug related adverse events.|From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.|The treated set (TS) included all subjects who were dispensed study medication and were documented to have taken at least 1 dose of the investigational treatment.||Percentage of Participants|||Number
678660|NCT01594424|Primary|Number of Participants With Serious Infectious Complications Following Transplantation|patients will be in the study for up to 2 years|24 months|||participants|||Number
678661|NCT01594411|Primary|Change in Clinicians' Treatment Decision After Gene Expression Testing|The primary objective was to assess whether the Gene Expression Score (GES) altered clinicians' evaluations, defined by a change in patient management from preliminary to final decision. The change was prospectively defined as a downgrade or upgrade in intensity of the diagnostic plan based on the following hierarchical categories:(1) no further cardiac testing or treatment, (2) lifestyle changes or medical therapy, (3) stress testing (with or without imaging) or computed tomography/coronary angiography, or (4) invasive coronary angiography. The GES algorithm comprises expression values for 23 genes from peripheral blood cells in 6 terms, patient age, and sex. The changes in gene expression are quantified using an algorithm that generates a GES ranging from 1 to 40. A score <=15 indicates a low risk of underlying obstructive coronary disease. The GES has a negative predictive value of 96% for GES <=15 in a popluation referred to myocardial perfusion imaging.|pre- and post- gene expression testing results (on avaerage 2-3 days to receive GES)|The study sites included 9 clinicians at 4 community-based primary care practices who assessed all participants with a valid GES.||number of subjects|||Number
678671|NCT01593215|Secondary|Glucose|Plasma glucose will be measure (mMole) in response to an oral glucose tolerance test. Patients will receive the capsules 1 h before the glucose test, and the glucose levels 30 minutes after the oral glucose will be used as a secondary outcome measure. The glucose levels at the highest tolerated dose of yohimbine will be used.|30 minutes after oral glucose||||||
678672|NCT01593215|Primary|Insulin Secretion|insulin secretion will be measured (nMole) in response to an oral glucose tolerance test. Patients will receive the capsules 1 h before the glucose test, and the insulin levels 30 minutes after the oral glucose will be used as a primary outcome measure. The insulin levels at the highest tolerated dose of yohimbine will be used.|30 minutes after oral glucose|||% increase of Ins30||95% Confidence Interval|Mean
678673|NCT01594294|Secondary|Median Non-Invasive Pre-Lens Tear Film Break Up Time (PL-NIBUT)|The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eyelid and the contact lens). The time required for a dry spot to appear on the pre-lens surface after blinking is referred to as the pre-lens tear film break up time. PL-NIBUT was evaluated using a biomicroscope with a diffuse illumination source, i.e., Tearscope. A longer PL-NIBUT indicates a more stable tear film and greater on-eye lens wettability. Three PL-NIBUT measurements were recorded, and the median value was used for analysis. Both eyes were included in the model for analysis. Contact lenses were on-eye for this assessment.|Month 3|This analysis population includes all participants who completed the study as per the protocol, minus missing responses.||seconds|Participants|Standard Deviation|Mean
678674|NCT01594294|Primary|Mean Upper Eyelid Margin Staining|The contact lens was removed and ophthalmic dye was instilled. Upper eyelid margin staining was objectively measured through digital images. The extent of true staining (i.e., the total area of lid margin covered by staining) was recorded. Both eyes were included in the model for analysis. Contact lenses were not worn for this assessment.|Baseline (Day 0), Month 3|This analysis population includes all participants who completed the study as per the protocol, minus missing responses.||square millimeters|Participants|Standard Deviation|Mean
678675|NCT01594294|Primary|Mean Upper Eyelid Redness|The contact lenses were removed and upper eyelid redness was objectively measured through digital images. The coverage of the palpebral surface by blood vessels is expressed as percentage of the total surface measured. Both eyes were included in the model for analysis. Contact lenses were not worn for this assessment.|Baseline (Day 0), Month 3|This analysis population includes all participants who completed the study as per the protocol, minus missing responses.||percentage of total surface measured|Participants|Standard Deviation|Mean
678676|NCT01594294|Primary|Maximum Eyelid Hyperaemia|Eyelid hyperaemia (redness) was recorded separately for three zones of the upper lid and overall for the lower lid on a 5-point forced choice scale: 0 = Clear; 1 = Slight redness; 2 = Mild redness; 3 = Moderate redness; 4 = Severe redness). The maximum value represents the worst grade in any zone. Both eyes were included in the model for analysis. Contact lenses were not worn for this assessment.|Baseline (Day 0), Month 3|This analysis population includes all participants who completed the study as per the protocol, minus missing responses.||units on a scale|Participants|Full Range|Median
678677|NCT01594294|Primary|Maximum Papillae|Eyelid papillae (bumps on the inner eyelid) were recorded separately for three zones of the upper lid and overall for the lower lid on a 5-point forced choice scale: 0 = None; 1 = Slight (diffuse papillae); 2 = Mild (diffuse & tufts papillae); 3 = Moderate (moderate & tufts papillae); 4 = Severe (giant papillae). The maximum value represents the worse grade in any zone. Both eyes were included in the model for analysis. Contact lenses were not worn for this assessment.|Baseline (Day 0), Month 3|This analysis population includes all participants who completed the study as per the protocol, minus missing responses.||Units on a scale|Participants|Full Range|Median
678678|NCT01594125|Secondary|Number of Participants With Response by Alpha Fetoprotein (AFP)|Response by AFP is defined as 20% or more decline in AFP between the baseline value and the AFP value after three courses (12 weeks) of therapy. If patients only receive two courses of therapy the AFP value after two courses (8 weeks) will be used for the analysis.|up to 28 months|Patients from TS and AFP evaluation (>20μg/L) at baseline and post-baseline AFP assessment after two or three courses.||participants|||Number
678679|NCT01594125|Secondary|Time to Progression (TTP)|TTP is defined as the duration from the start date of the study treatment to PD according to RECIST 1.0.|up to 28 months|Patients from TS||months||Inter-Quartile Range|Median
678680|NCT01594125|Secondary|Progression Free Survival (PFS)|PFS is defined as the duration from start date of the study treatment to PD according to RECIST 1.0, or any death whichever occurs earlier.|up to 28 months|Patients from TS||months||Inter-Quartile Range|Median
678681|NCT01594125|Secondary|Number of Participants With Objective Tumour Response According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.0|Objective response (Complete response (CR) + Partial response (PR), regardless of confirmation) is derived from a patient’s best objective response by RECIST. Best objective response is calculated based on the “overall” visit response from each assessment. Best objective response represents the best response a patient has had during their time in the study up until progression, last evaluable assessment in the absence of progression or the start of subsequent anti-cancer therapy. For patients whose progression event is death, best objective response will be calculated based on data up until the last evaluable RECIST assessment prior to death.|up to 28 months|Treated Set (TS): The treated set includes all patients who were administered at least one dose of any study medication.||participants|||Number
678682|NCT01594125|Primary|Number of Participants With Dose Limiting Toxicities to Determine Maximum Tolerated Dose (MTD) of Nintedanib|The MTD is based on the incidence of Dose Limiting Toxicities (DLTs). A drug-related AE was considered as a DLT if one of the following met: CTCAE grade 4 thrombocytopenia of any duration, CTCAE grade 4 neutropenia lasting for ≥8 days, CTCAE grade 4 febrile neutropenia of any duration, CTCAE grade 3 or 4 non-haematologic toxicity (with the following exception: Alopecia, Vomiting, nausea, or diarrhoea with no adequate supportive care, Transient electrolyte abnormality, which resolves spontaneously or can be corrected with appropriate treatment within 3 days, Liver toxicity), Liver enzyme toxicity of AST, ALT, alkaline phosphatase [ALP] elevation >5x ULN, or total bilirubin >3x ULN if baseline liver enzymes are within the normal range, or AST, ALT or ALP > baseline value + 4x ULN if the baseline value is elevated. The MTD was determined to be 200mg bid.|up to 28 days|Patients from the MTD set: The MTD set contains only treated patients from the dose escalation that were not replaced for MTD determination.||participants|||Number
678683|NCT01593852|Primary|Cumulative Air Kerma (AK) Value|Percentage reduction of reducted X-ray dose settings (Allura Clarity) vs. regular X-ray dose settings (AlluraXper) in AK.|Day 0|||mGy||Inter-Quartile Range|Median
678684|NCT01593852|Secondary|Serious Adverse Events||Day 0 if any|||participants|||Number
678685|NCT01593852|Secondary|Usage of Physician Controlled Dose Settings|In both groups, default fluoroscopy dose settings were 'low', but could be changed by the operator to a medium or high setting for better imaging. The necessity to increase fluoroscopy dose for better imaging to medium or high was registered as a percentage of total number of fluoroscopy frames.|Day 0|||percentage of total # of fluoro frames||Standard Deviation|Mean
678686|NCT01593852|Secondary|Physician Professional Judgment on Adequacy of Images for Performing the EP Procedure|If fluoroscopy time (see results in other secondary outcomes), number of exposure frames (see below) and procedure duration (see results in other secondary outcomes) are equivalent between the two groups, this will indicate that image quality (IQ) is equally adequate in both groups.|Day 0|||Number of exposure frames||Standard Deviation|Mean
678687|NCT01593852|Secondary|Fluoroscopy Time||Day 0|||minutes||Standard Deviation|Mean
678688|NCT01593852|Secondary|Procedure Duration||Day 0|||minutes||Standard Deviation|Mean
678689|NCT01593852|Secondary|Physician Professional Judgment on Procedural Success|Measurement of professional judgment (yes/no) of the treating physician.|Day 0|||percentage of procedural success|||Number
678690|NCT01593852|Secondary|Staff Dose Measured by DoseAware and Electronic Personal Dosimeter (EPD)|Staff dose measured by Electronic Personal Dosimeter (EPD) worn by the operator over the lead apron (EPD operator) and the other mounted at a fixed location in the EP laboratory (EPD fixed)|Day 0|||µSv||Inter-Quartile Range|Median
678691|NCT01593852|Primary|Cumulative Dose Area Product (DAP) Value|Percentage reduction of reduced X-ray dose settings (Allura Clarity) vs. regular X-ray dose settings (AlluraXper) in DAP.|Day 0|||Gy*cm^2||Inter-Quartile Range|Median
678692|NCT01593787|Secondary|Percentage of Participants Achieving a Successful Response Rate in msDBP at Week 8|Successful response rate was defined as msDBP <80 mmHg or a reduction of ≥10 mmHg from baseline.|8 weeks|FAS||Percentage of participants|||Number
678693|NCT01593787|Secondary|Percentage of Participants Achieving a Successful Response Rate in msSBP at Week 8|Successful response rate was defined as msSBP <130 mmHg or a reduction of ≥20 mmHg from baseline|8 weeks|FAS||Percentage of participants|||Number
678694|NCT01593787|Secondary|Percentage of Participants Achieving DBP Control at Week 8|DBP control was defined as msDBP <80 mmHg.|8 weeks|FAS||Percentage of participants|||Number
678695|NCT01593787|Secondary|Percentage of Participants Achieving SBP Control at Week 8|SBP control was defined as msSBP <130 mmHg.|8 weeks|FAS||Percentage of participants|||Number
678696|NCT01593787|Secondary|Percentage of Participants Achieving a Successful BP Control at Week 8|A successful BP control was defined as msSBP <130 mmHg and msDBP <80 mmHg|8 weeks|FAS||Percentage of Participants|||Number
678697|NCT01593787|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Week 8||baseline, 8 weeks|FAS||mmHg||Standard Deviation|Mean
678698|NCT01593787|Secondary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Week 8|Sitting BP measurements were performed at screening through the end of study at every visit. Four separate sitting BP were obtained with a full two-minute interval between measurements.|baseline, 8 weeks|Full Analysis Set (FAS): This set included all participants who entered the treatment epoch. Patients who were not qualified to enter the treatment epoch were excluded from the FAS provided those participants did not receive LCZ696.||mmHg||Standard Deviation|Mean
678699|NCT01593787|Primary|Percentage of Participants With Reported Adverse Events (Total Adverse Events, Serious Adverse Events and Death)|Percentage of patients with total adverse events, serious adverse events and death were reported.|8 weeks|Safety Set: This set included all participants who received at least one dose of LCZ696. AE analysis was determined by actual treatment, i.e. the LCZ696 dose on the day in which the corresponding summary was targeting. Other safety analysis was determined by the maximum treatment.||Percentage of participants|||Number
678700|NCT01593722|Other Pre-specified|Treatment Efficacy|Proportion of subjects without signs of infection|6 months|Microfilarial count and symptoms||participants|||Number
678701|NCT01593722|Secondary|Proportion of Subjects Who Clear Microfilaremia||14 days|||participants|||Number
678702|NCT01593722|Secondary|Eosinophil Activation|Levels of surface marker expression on eosinophils|3 days|||% cells expressing CD69||Full Range|Geometric Mean
678703|NCT01593722|Secondary|The Frequency of Adverse Events|Symptoms, signs and laboratory abnormalities occurring in the 7 days post-treatment|7 days|||events|||Number
678704|NCT01593722|Primary|The Peak % of Baseline Eosinophil Count Measured During the First 7 Days Post-treatment.||7 days|||percentage of baseline||Full Range|Geometric Mean
678705|NCT01593670|Secondary|Overall Survival|Patients alive at 1 year.|1 Year|||Participants|||Count of Participants
678706|NCT01593670|Secondary|Number of Patients Who Had Natural Killer (NK) Cell Expansion|NK cell expansion is defined as the presence of donor NK cells in the recipient at Day 8 post NK cell infusion.|After Cycle 2 (approx. 3 months)|||Participants|||Count of Participants
678742|NCT01592695|Secondary|Treatment Attendance|The number of treatment calls completed (out of six total) will be calculated for all participants in the Tailored Intervention group as an indicator of the feasibility of the treatment approach.|End of treatment (seven weeks after baseline)|Attendance rate (number of counseling calls completed out of 6) among those assigned to the tailored intervention condition.||Calls||Full Range|Mean
678708|NCT01593670|Secondary|Number of Patients Who Experienced Grade 3 or Higher Non-hematologic Adverse Events|Adverse events (AEs) will be graded using Common Terminology Criteria for Adverse Events v4.0 (CTCAE). Non-hematologic adverse events are defined as untoward medical occurrences associated with the use of a study drug whether or not considered study drug related, excluding those events involving white blood cells, neutrophils, red blood cells or platelets. In general, grade 3 AEs are defined as 1) being severe or medically significant but,not immediately life-threatening; 2) requiring hospitalization or prolongation of hospitalization; 3) disabling; or 4) limiting self care activities. Grade 4 AEs are defined as 1) having life-threatening consequences; or 2) requiring urgent intervention. Grade 5 AEs are defined as causing death related to an adverse event.|Day 1 through Month 3|||Participants|||Count of Participants
678709|NCT01593670|Primary|The Number of Patients Who Achieved a Clinical Response|Clinical response includes: Complete Response (less than 5% myeloblasts present in the bone marrow and in the peripheral blood a hemoglobin of at least 11g/dl, platelets of at least 100 X 10E9/L, neutrophils of at least 1.0 X 10E9/L, and blasts 0%); Partial Response (all Complete Response criteria if previously abnormal except bone marrow myeloblasts are decreased by more than 50% over pre-treatment, but still greater than 5%); and hematologic improvement (a hemoglobin increase of greater than 1.5g/dl or decreased red blood cell transfusions by at least 4 per 8 week period, a platelet increase of more than 30 X 10E9/L for patients with a baseline of more than 20 X 10E9/L or an increase by 100% for those with a baseline of less than 20 X 10E9/L, and a neutrophil increase of at least 100% and an absolute increase of greater than 0.5 X 10E9/L.|After 2 Courses of Treatment (Approx. 3 months)|||Participants|||Count of Participants
678710|NCT01593592|Secondary|The Secondary End Point Was the Development of Severe Adverse Effects to the Used Medications and Dietary Supplements.|Severe adverse effects to the used medications and dietary supplements, these may expose the participants to major morbidity and may change the outcomes in them.|8 weeks|||participants|||Number
678711|NCT01593592|Secondary|Severe Adverse Effects to the Used Medications and Dietary Supplements.||4 weeks|||percentage of participants|||Number
678712|NCT01593592|Primary|Eradication of H Pylori Infection 4 Weeks After Completion of Therapy|H. pylori eradication is defined in this study as concomitant negativity to all previously positive tests (H. pylori antigen in stool; histopathological confirmation of H. pylori bacilli; and rapid urease test.) 4 weeks after the end of therapy.|4 weeks therapy|It is assessment of all the 70 participants about H pylori eradication status||participants|||Number
678713|NCT01592864|Secondary|Adjusted Mean Change From Baseline in Tactile Sensitivity Pain Response at Week 4|Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale. The constant pressure probe allowed the examiner to vary the force applied to the dentin surface from 10g to an upper threshold of 80g, in increments of 10g. The greater the pressure the subject was able to tolerate, the less sensitive the tooth. According to this tactile sensitivity assessment, an increasing force was applied to hypersensitive tooth until a yes response is recorded or the maximum force has been reached. Change from baseline in tactile response to Week 4 was calculated|Baseline to 4 weeks post administration of study treatment|ITT Population: All randomized participants, who were administered with at least one study treatment during the study and provided at least one post-baseline assessment of efficacy. Missing values were not imputed.||grams||Standard Deviation|Mean
678714|NCT01592864|Secondary|Adjusted Mean Change From Baseline in Tactile Sensitivity Pain Response at Week 8|"Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale. The constant pressure probe allowed the examiner to vary the force applied to the dentin surface from 10 grams (g) to an upper threshold of 80 g, in increments of 10g since the values below represents adjusted mean change in baseline, the value can fall below scale range. The greater the pressure the subject was able to tolerate, the less. Change from baseline in tactile response to Week 8 was calculated.
sensitive the tooth. According to this tactile sensitivity assessment, an increasing force was applied to hypersensitive tooth until a yes response is recorded or the maximum force has been reached."|Baseline to 8 weeks post administration of study treatment|ITT Population: All randomized participants, who were administered with at least one study treatment during the study and provided at least one post-baseline assessment of efficacy. Missing values were not imputed.||grams||Standard Deviation|Mean
678715|NCT01592864|Secondary|Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Week 4|Response to a constant jet of air applied to hypersensitive teeth was evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant does not respond to air stimulation, 1 - participant responds to air stimulus but does not request discontinuation of stimulus, 2 - participant responds to air stimulus and request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus.|Baseline to 4 weeks post administration of study treatment|ITT Population: All randomized participants, who were administered with at least one study treatment during the study and provided at least one post-baseline assessment of efficacy. Missing values were not imputed.||Score on a scale||Standard Deviation|Mean
678716|NCT01592864|Primary|Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Week 8|Response to a constant jet of air applied to hypersensitive teeth is evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant does not respond to air stimulation, 1 - participant responds to air stimulus but does not request discontinuation of stimulus, 2 - participant responds to air stimulus and request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus.|Baseline to 8 weeks post administration of study treatment|Intent to Treat (ITT) Population: All randomized participants, who were administered with at least one study treatment during the study and provided at least one post-baseline assessment of efficacy. Missing values were not imputed.||Score on a scale||Standard Deviation|Mean
678743|NCT01592695|Secondary|Retention|The number of participants who remain in the study throughout the seven-week treatment period will be computed as an indicator of the feasibility of the treatment approach.|End of treatment (seven weeks after baseline)|Participants assigned to the tailored intervention condition who completed the intervention calls.||Participants|||Count of Participants
678717|NCT01592851|Secondary|Change From Baseline in Tactile Pain Threshold Score Immediately Post-treatment|"The Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale (10g to 80g). According to this tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response to pain is recorded or the maximum force has been reached. Tactile testing begins with a force of 10g and it is increased by 10g, with each successive challenge, until either a yes response is recorded or the maximum force (80g) is reached. An increase in tactile score from baseline represents an improvement in sensitivity."|Baseline to immediately post treatment administration|ITT population: All randomized participants, who were administered with at least one study treatment during the study and provided at least one post-baseline assessment of efficacy.||Force (grams)||Standard Deviation|Mean
678718|NCT01592851|Secondary|Change From Baseline in Tactile Pain Threshold Score at Day 3|"The Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale (10g to 80g). According to this tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response to pain is recorded or the maximum force has been reached. Tactile testing begins with a force of 10g and it is increased by 10g, with each successive challenge, until either a yes response is recorded or the maximum force (80g) is reached. An increase in tactile score from baseline represents an improvement in sensitivity."|Baseline to Day 3|ITT population: All randomized participants, who were administered with at least one study treatment during the study and provided at least one post-baseline assessment of efficacy.||Force (grams)||Standard Deviation|Mean
678719|NCT01592851|Secondary|Change From Baseline in Tactile Pain Threshold Score at Day 14|"The Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale (10g to 80g). According to this tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response to pain is recorded or the maximum force has been reached. Tactile testing begins with a force of 10g and it is increased by 10g, with each successive challenge, until either a yes response is recorded or the maximum force (80g) is reached. An increase in tactile score from baseline represents an improvement in sensitivity"|Baseline to Day 14|ITT population: All randomized participants, who were administered with at least one study treatment during the study and provided at least one post-baseline assessment of efficacy.||Force (grams)||Standard Deviation|Mean
678720|NCT01592851|Secondary|Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Day 3|Response to a constant jet of air applied to hypersensitive teeth is evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant does not respond to air stimulation, 1 - participant responds to air stimulus but does not request discontinuation of stimulus, 2 – participant responds to air stimulus and request discontinuation of stimulus, 3 – participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus. Those teeth that met the tactile threshold inclusion criterion (tactile threshold ≤ 20g) were assessed at baseline and Day 3. The Investigator directed a second application of air from a standard dental syringe to the facial surface of the two sensitive teeth selected at baseline. The Schiff Sensitivity Score was calculated as the subject level mean change (on two teeth) from baseline.|Baseline to Day 3|ITT population: All randomized participants, who were administered with at least one study treatment during the study and provided at least one post-baseline assessment of efficacy.||Score on a scale||Standard Deviation|Mean
678721|NCT01592851|Secondary|Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale Immediately Post-treatment|Response to a constant jet of air applied to hypersensitive teeth is evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant does not respond to air stimulation, 1 - participant responds to air stimulus but does not request discontinuation of stimulus, 2 – participant responds to air stimulus and request discontinuation of stimulus, 3 – participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus. Those teeth that met the tactile threshold inclusion criterion (tactile threshold ≤ 20g) were assessed at baseline and immediately after treatment. The Investigator directed a second application of air from a standard dental syringe to the facial surface of the two sensitive teeth selected at baseline. The Schiff Sensitivity Score was calculated as the subject level mean change (on two teeth) from baseline.|Baseline to immediately post treatment administration|ITT population: All randomized participants, who were administered with at least one study treatment during the study and provided at least one post-baseline assessment of efficacy.||Score on a scale||Standard Deviation|Mean
678722|NCT01592851|Primary|Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Day 14|Response to a constant jet of air applied to hypersensitive teeth is evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant does not respond to air stimulation, 1 - participant responds to air stimulus but does not request discontinuation of stimulus, 2 – participant responds to air stimulus and request discontinuation of stimulus, 3 – participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus. Those teeth that met the tactile threshold inclusion criterion (tactile threshold ≤ 20g) were assessed at baseline and Day 14. The Investigator directed a second application of air from a standard dental syringe to the facial surface of the two sensitive teeth selected at baseline. The Schiff Sensitivity Score was calculated as the subject level mean change (on two teeth) from baseline.|Baseline to Day 14|Intent To Treat (ITT) population: All randomized participants, who were administered with at least one study treatment during the study and provided at least one post-baseline assessment of efficacy.||Score on a scale||Standard Deviation|Mean
678744|NCT01592695|Secondary|Enrollment Rate|The number of participants enrolled will be tracked as a measure of the feasibility of the intervention approached for the entire six-month recruitment period.|6 months after study initiation|Total number of participants randomized to each treatment condition.||Participants|||Count of Participants
678745|NCT01592695|Secondary|Body Weight|Self-reported body weight.|Six-month follow-up|Assessed among participants in the tailored intervention group who received the weight management module and those in the enhanced standard of care condition who would have been eligible for the weight management module if they had been assigned to the tailored intervention condition.||Pounds||Standard Deviation|Mean
678723|NCT01592786|Primary|Number of Confirmed Social Responsiveness Scale (SRS) Responders|"A confirmed SRS responder was defined as a patient who had at least 12 weeks of exposure to memantine, and a ≥ 10-point reduction in the SRS total raw score relative to baseline at 2 consecutive visits separated by at least 2 weeks.
The SRS is a 65-item, caregiver-rated assessment scale that measures observable items on social behavior and social language use, as well as characteristics of autism in a naturalistic social setting. Each item is rated on a scale from 0 (never true) to 3 (almost always true). The SRS total raw score ranges from 0 to 195; a higher score indicates greater severity of social impairment."|Visit 1 (Baseline) to Visit 8 (week 48/Final Visit)|Of the 906 patients who enrolled in the study 903 received at least 1 dose of open-label treatment to comprise the Safety Population. The Intent to Treat (ITT) population included the 868 patients in the Safety population who also had at least 1 post–Visit 1 assessment of the SRS total raw score.||participants|||Number
678724|NCT01592773|Primary|Patients With Any Treatment-emergent Adverse Event|Number of patients who experienced 1 or more Treatment Emergent Adverse Event|Visit 1 (Week 0) up to 30 days after Visit 8 (up to Week 48) or Final Visit|Analysis was performed on the 747 patients who took at least 1 dose of investigational product (Safety Population).||participants|||Number
678725|NCT01592760|Secondary|Oropharyngolaryngeal Morbidity at 24 Hours Post-operatively|Perioperative oropharyngolaryngeal morbidity is assessed by the subject's response to standardized questions regarding oropharyngeal complaints.|Measured at 24 hours after device placement/study initiation|||participants|||Number
678726|NCT01592760|Secondary|Oropharyngolaryngeal Morbidity at Discharge|Perioperative oropharyngolaryngeal morbidity is assessed by the subject's response to standardized questions regarding oropharyngeal complaints.|Measured prior to discharge from phase II of the post-anesthesia care unit/recovery room|||participants|||Number
678727|NCT01592760|Secondary|Overall Clinical Usefulness|Excellent, good, fair, or inadequate. Scale defined by clinical measures and observations.|Reported by the device operator at the time of device removal|||participants|||Number
678728|NCT01592760|Secondary|Incidence of Oropharyngeal Injury|Oropharyngeal injury is defined as a new lip, tongue, buccal, or pharyngeal abrasion or laceration or dental damage observed in the immediate recovery area after use of a study device.|Measured in the post-anesthesia care unit/recovery room within 15 minutes after device removal|||participants|||Number
678729|NCT01592760|Secondary|Incidence of Gastric Aspiration|Gastric aspiration is present when gross gastric contents or bile is observed on or within the device or within the subject's oropharynx. The outcome is the proportion of study subjects in whom the outcome measure was observed.|Measured between successful device placement and device removal for any reason.|||participants|||Number
678730|NCT01592760|Secondary|Incidence of Gastric Insufflation|Gastric insufflation is present when audible air sounds are heard by stethoscope over the subject's epigastrium.|Measured within 5 minutes of device placement/study initiation|||participants|||Number
678731|NCT01592760|Secondary|Device Use Time (Min)|Device Use Time is the time recorded to the nearest minute of the period bounded by the time the device placement was determined to be adequate in the study subject to its withdrawal from the study subject.|Measured between successful device placement and device removal for any reason, approximately 2 hours|||minutes||Standard Deviation|Mean
678732|NCT01592760|Secondary|Device Position in Relation to the Vocal Cords|Device position in relation to the vocal cords is assessed with a flexible fiberoptic camera and graded as follows: 1 = full view of the vocal cords, 2 = partial view of the vocal cords including the arytenoids, 3 = view of the epiglottis only, and 4 = other (device cuff, pharynx or other structures).|Measured within 5 minutes of successful study device placement|||participants|||Number
678733|NCT01592760|Secondary|Device Ease of Insertion|Device ease of insertion is graded as either easy, slightly difficult, difficult, or impossible. The outcome measure is the proportion of successful study device placements recorded as easy versus slightly difficult versus difficult versus impossible.|Reported by the device operator at the time successful device placement is recorded.|||participants|||Number
678734|NCT01592760|Secondary|Device Placement Success Rate|Device placement success rate is defined as the proportion of devices successfully placed within three attempts at device placement.|Measured at the time of attempted study device placement immediately after the induction of general anesthesia|||participants|||Number
678735|NCT01592760|Secondary|Device Placement Time|Device placement time is the time measured in seconds from when the study investigator picks up the airway device to confirmation of ventilation by the presence of an adequate end-tidal carbon dioxide tracing on the monitor.|Measured at device placement/study initiation|||seconds||Standard Deviation|Mean
678736|NCT01592760|Primary|Airway Seal Pressure After Device Placement|Airway seal pressure is defined as the pressure in cmH2O at which the needle of a manometer attached to the anesthesia circuit reaches equilibration, associated with an audible air leak from the subject's oropharynx or gastric insufflation, limited to a maximum pressure of 40 cmH2O. It is measured with the subject's head and neck in neutral position, the expiratory valve on the anesthesia machine closed, and the fresh gas flow set to five liters per minute.|Measured within 5 minutes after device placement/study initiation|||cmH2O||Standard Deviation|Mean
678737|NCT01592708|Secondary|Post-discharge Vomiting||1 week post discharge|This analysis only possible with patients who successfully completed the post-discharge diary. Therefore, the participant number differs from the total patients enrolled.||percentage of subjects with PDV|||Number
678738|NCT01592708|Primary|Post-operative Vomiting||End of surgery to discharge from hospital|||percentage of subjects with POV|||Number
678739|NCT01592708|Secondary|Post-discharge Nausea|To be assessed based on patient diary completed daily for 1 week following discharge to home from the hospital|1 week from discharge from hospital|This analysis only possible with patients who successfully completed the post-discharge diary. Therefore, the participant number differs from the total patients enrolled.||percentage of subjects with PDN|||Number
678740|NCT01592708|Secondary|Hospital Length of Stay|Anesthesia start time determined from anesthesia portion of the medical record. Time at which discharge order was placed will serve as time of discharge.|Anesthesia start time to placement of hospital discharge order - average 26 - 28 hours|||hours||Inter-Quartile Range|Median
678741|NCT01592708|Primary|Post-operative Nausea|End of surgery time determined by anesthesia portion of the medical record. PONV to be assessed by review of surgeons' and nurses' notes in the medical record as well as through review of patient diaries. Vomiting constitutes a safety issue and, as such, associated adverse events will be noted.|End of surgery to discharge from hospital|||percentage of subjects with PON|||Number
678746|NCT01592695|Secondary|Depressive Symptoms|Depressive symptoms as measured using the Patient Health Questionnaire 9 (PHQ-9). Possible scores range from 0 to 27, with higher scores indicating greater levels of depressive symptoms.|Six-month follow-up|Participants in the tailored intervention group who receive the mood management module and those in the enhanced standard of care condition who would have been eligible for the mood management module if they had been assigned to the tailored intervention condition.||units on a scale||Standard Deviation|Mean
678747|NCT01592695|Secondary|Alcohol Use|Alcohol use during the previous seven days will be assessed among those receiving the risky alcohol use treatment module and those in the quitline referral condition who would have been eligible for the intervention if assigned to the tailored treatment group.|Six-month follow-up|Participants in the tailored intervention group who received the alcohol intervention and those in the enhanced standard of care group who would have been eligible for the alcohol intervention if they had been assigned to the tailored intervention group.||Drinks consumed per day||Standard Deviation|Mean
678748|NCT01592695|Secondary|Number of Participants Abstinent From Tobacco Use|At the six-month follow-up contact, participants will be questioned regarding self-reported tobacco use over the past seven days (point prevalence abstinence).|Six-month follow-up|7-day point prevalence abstinence at 6 months. Those with missing data treated as smokers (penalized imputation).||Participants|||Count of Participants
678749|NCT01592695|Primary|Treatment Satisfaction|Participants' impressions of and satisfaction with the intervention will be assessed by interview at the end of treatment.|End of treatment (seven weeks after baseline)|Participants who completed treatment satisfaction items on three-month follow-up||Participants|||Count of Participants
678750|NCT01592435|Primary|Radlex Scale for Diagnostic Capability Ratings - Carestream DR LLI Software (Investigational)|1-Non-diagnostic - Unacceptable for diagnostic purposes. 2-Limited - Acceptable, with some technical defect. 3-Diagnostic - Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary - Good, most adequate for diagnostic purposes.|5 weeks after completion of data collection|||units on a scale||Standard Error|Mean
678751|NCT01592435|Primary|Radlex Scale for Diagnostic Capability Ratings - Cedara Accustitch Software (Predicate)|1-Non-diagnostic - Unacceptable for diagnostic purposes. 2-Limited - Acceptable, with some technical defect. 3-Diagnostic - Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary - Good, most adequate for diagnostic purposes.|5 weeks after completion of data collection|||units on a scale||Standard Error|Mean
678752|NCT01592396|Secondary|Number of Participants Exhibiting Anti-Drug Antibodies for Tralokinumab at Any Visit|Immunogenicity assessment included determination of anti-drug antibodies to tralokinumab (CAT-354) antibodies in serum samples. Immunogenicity results were summarized together for all participants.|Day 1 and Day 57|PK population included all participants who received the investigational product and had at least 1 detectable post dosing tralokinumab (CAT-354) serum concentration.||participants|||Number
678753|NCT01592396|Secondary|Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between administration of study drug and up to Day 57 that were absent before treatment or that worsened relative to pre-treatment state. Adverse events were summarized together for all participants.|Day 1 to Day 57|Safety population included all participants who received investigational product.||participants|||Number
678754|NCT01592396|Primary|Terminal Phase Elimination Half Life (t1/2)|Terminal phase elimination half-life is the time measured for the serum concentration to decrease by one half.|0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57|PK population included all participants who received the investigational product and had at least 1 detectable post dosing tralokinumab (CAT-354) serum concentration.||days||Standard Deviation|Mean
678755|NCT01592396|Primary|Area Under the Concentration-Time Curve From Zero to Last Measurable Concentration (AUC [0-t])||0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57|PK population included all participants who received the investigational product and had at least 1 detectable post dosing tralokinumab (CAT-354) serum concentration.||mcg*day/mL||Standard Deviation|Mean
678756|NCT01592396|Primary|Area Under the Concentration-time Curve From Zero to Infinity (AUC [0-infinity])|AUC (0 - infinity) = Area under the serum concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - infinity). It is obtained from AUC (0 - t) plus AUC (t - infinity).|0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57|PK population included all participants who received the investigational product and had at least 1 detectable post dosing tralokinumab (CAT-354) serum concentration.||(microgram*day)/milliliter (mcg*day/mL)||Standard Deviation|Mean
678757|NCT01592396|Primary|Maximum Observed Serum Concentration (Cmax)||0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57|PK population included all participants who received the investigational product and had at least 1 detectable post dosing tralokinumab (CAT-354) serum concentration.||microgram per milliliter (mcg/mL)||Standard Deviation|Mean
678758|NCT01592396|Primary|Time to Reach Maximum Observed Serum Concentration (Tmax)||0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57|Pharmacokinetic (PK) population included all participants who received the investigational product and had at least 1 detectable post dosing tralokinumab (CAT-354) serum concentration.||days||Full Range|Median
678759|NCT01592344|Secondary|Patient Satisfaction Will be Assessed Using a Patient Satisfaction Survey|Patient satisfaction with the StimRouter System was rated on a numerical rating scale (range 0 to 10), with 0 indicating not satisfied at all and 10 indicating completely satisfied.|at the 3-month follow-up|All subjects who completed the survey at Month 3 were included in this analysis. Four subjects in each study arm (4/45 Treatment; 4/49 Control) failed to complete the satisfaction survey.||units on a scale||Standard Deviation|Mean
678821|NCT01591616|Secondary|Vital Signs (Pulse)|Vital signs (pulse, systolic and diastolic pressure) were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.|Pre-dose and every 10 minute to 240 minutes post-dose.|||Beats per minute||Full Range|Mean
678760|NCT01592344|Secondary|Worst Pain in the Last 24 Hours Will be Assessed Using 7-day Patient Pain Diary Scores for BPI SF #3.|"Worst pain in the last 24 hours assessed using 7-day patient pain diary scores for BPI ranging from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine. Change from baseline to Month 3 was compared."|at baseline and 3 month follow-up|All available data were analyzed from both treatment arms.||units on a scale||Standard Deviation|Mean
678761|NCT01592344|Secondary|Patient Global Impression of Improvement With Treatment Will be Assessed Using the Patient Global Impression of Change Scale (PGIC).|Patient Global Impression of Change in activity limitations, symptoms, emotions and overall life quality related to their painful condition (Range 1 to 7, with 1 indicating no change and 7 indicating a great deal better/considerable improvement).|at 3 month follow-up|All patients who completed the 3 month Global Impression of Change questionnaire were included. Four patients in each study arm failed to complete the questionnaire.||units on a scale||Standard Deviation|Mean
678762|NCT01592344|Primary|Brief Pain Inventory (BPI): Number of Participants With a Pain Reduction of Greater Than or Equal to 30%|The average pain at rest was assessed using a numerical (0-10) rating scale (NRS) on the Brief Pain Inventory (BPI) Short Form (SF). A higher score indicates worse pain (10=worst pain imaginable) and zero indicates 'no pain at all'. A pain reduction of greater than or equal to 30% on the NRS was considered to be clinically relevant.|Baseline and at 3-month follow-up.|Intent to treat (ITT) population was analyzed.||participants|||Number
678763|NCT01592292|Secondary|Safety: Number of Participants With Adverse Events (AE), Adverse Drug Reactions (ADR) and Serious Adverse Events|An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. ADRs were defined as any response to a drug which was noxious and unintended, and which occurred at dose normally used related to the pharmacological properties. A SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant.|Baseline up to Month 12|The ITT set included participants who offered end-point results among the participants who received study drugs after enrollment and met all inclusion/exclusion criteria.||participants|||Number
678764|NCT01592292|Secondary|Efficacy: Health Assessment Questionnaire-Disability Index (HAQ-DI) in Standard Population Set (SPS)|The HAQ-DI is a participant-completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0 (without any difficulty) to 3 (unable to do). The overall HAQ-DI score is the average of each of the 8 category scores and ranges from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability.|Month 6|The SPS included participants who maintained the secondary biological agent treatment selected for the first time for 6 months among the participants included in the ITT set. Here number of participants analyzed is the total participants who were evaluable for this outcome measure.||units on a scale||Standard Deviation|Mean
678765|NCT01592292|Secondary|Efficacy: Health Assessment Questionnaire-Disability Index (HAQ-DI) in Intention to Treat (ITT) Population|The HAQ-DI is a participant-completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0 (without any difficulty) to 3 (unable to do). The overall HAQ-DI score is the average of each of the 8 category scores and ranges from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability.|Month 6|The ITT set included participants who offered end-point results among the participants who received study drugs after enrollment and met all inclusion/exclusion criteria. Here number of participants analyzed is the total participants who were evaluable for this outcome measure.||units on a scale||Standard Deviation|Mean
678766|NCT01592292|Secondary|Efficacy: Mean Change From Baseline in C-reactive Protein (CRP) at Month 6 and 12 in Standard Population Set (SPS)|CRP is an inflammation marker. High levels of this protein indicate inflammation in diseases such as RA. A negative change from baseline represents a reduction in inflammation.|Baseline, Month 6 and 12|The SPS included participants who maintained the secondary biological agent treatment selected for the first time for 6 months among the participants included in the ITT set. Here, 'n' represents the participants who were evaluable at specific time point.||mg/dL||Standard Deviation|Mean
678767|NCT01592292|Secondary|Efficacy: Mean Change From Baseline in C-reactive Protein (CRP) at Month 6 and 12 in Intention to Treat (ITT) Population|CRP is an inflammation marker. High levels of this protein indicate inflammation in diseases such as RA. A negative change from baseline represents a reduction in inflammation.|Baseline, Month 6 and 12|The ITT set included participants who offered end-point results among the participants who received study drugs after enrollment and met all inclusion/exclusion criteria. Here, 'n' represents the participants who were evaluable at specific time point.||milligram/deciliter (mg/dL)||Standard Deviation|Mean
678768|NCT01592292|Secondary|Efficacy: Mean Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 6 and 12 in Standard Population Set (SPS)|ESR is an acute phase reactant and a measure of inflammation. A negative change from baseline represents a reduction in inflammation.|Baseline, Month 6 and 12|The SPS included participants who maintained the secondary biological agent treatment selected for the first time for 6 months among the participants included in the ITT set. Here, 'n' represents the participants who were evaluable at specific time point.||mm/hr||Standard Deviation|Mean
678769|NCT01592292|Secondary|Efficacy: Mean Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 6 and 12 in Intention to Treat (ITT) Population|ESR is an acute phase reactant and a measure of inflammation. A negative change from baseline represents a reduction in inflammation.|Baseline, Month 6 and 12|The ITT set included participants who offered end-point results among the participants who received study drugs after enrollment and met all inclusion/exclusion criteria. Here, 'n' represents the participants who were evaluable at specific time point.||millimeter/hour (mm/hr)||Standard Deviation|Mean
679002|NCT01589510|Secondary|Physician Assessment of Patient Compliance Compared to Previous Therapy|Physician assessment of patient compliance compared to previous therapy was assessed on a 3-point scale (better, equal, and worse). The numbers of patients in each category are presented.|Week 14|All patients with data for this outcome measure||Patients|||Number
678770|NCT01592292|Secondary|Efficacy: Mean Change From Baseline in Swollen Joint Count (SJC) at Month 6 and 12 in Standard Population Set (SPS)|SJC is a clinical method to quantify abnormalities in participants with RA. It reflects the amount of inflamed synovial tissue. The number of swollen joints were scored as swollen=1 and not swollen=0, and counted. A negative change from baseline represents an improvement (a reduction in the number of swollen joints).|Baseline, Month 6 and 12|The SPS included participants who maintained the secondary biological agent treatment selected for the first time for 6 months among the participants included in the ITT set. Here, 'n' represents the participants who were evaluable at specific time point.||number of swollen joints||Standard Deviation|Mean
678771|NCT01592292|Secondary|Efficacy: Mean Change From Baseline in Swollen Joint Count (SJC) at Month 6 and 12 in Intention to Treat (ITT) Population|SJC is a clinical method to quantify abnormalities in participants with RA. It reflects the amount of inflamed synovial tissue. The number of swollen joints were scored as swollen=1 and not swollen=0, and counted. A negative change from baseline represents an improvement (a reduction in the number of swollen joints).|Baseline, Month 6 and 12|The ITT set included participants who offered end-point results among the participants who received study drugs after enrollment and met all inclusion/exclusion criteria. Here, 'n' represents the participants who were evaluable at specific time point.||number of swollen joints||Standard Deviation|Mean
678772|NCT01592292|Secondary|Efficacy: Mean Change From Baseline in Tender Joint Count (TJC) at Month 6 and 12 in Standard Population Set (SPS)|TJC is a clinical method to quantify abnormalities in participants with RA. It is associated with the level of pain. The number of tender joints were scored as tender=1 and not tender=0, and counted. A negative change from baseline represents an improvement (a reduction in the number of tender joints).|Baseline, Month 6 and 12|The SPS included participants who maintained the secondary biological agent treatment selected for the first time for 6 months among the participants included in the ITT set. Here, 'n' represents the participants who were evaluable at specific time point.||number of tender joints||Standard Deviation|Mean
678773|NCT01592292|Secondary|Efficacy: Mean Change From Baseline in Tender Joint Count (TJC) at Month 6 and 12 in Intention to Treat (ITT) Population|TJC is a clinical method to quantify abnormalities in participants with RA. It is associated with the level of pain. The number of tender joints were scored as tender=1 and not tender=0, and counted. A negative change from baseline represents an improvement (a reduction in the number of tender joints).|Baseline, Month 6 and 12|The ITT set included participants who offered end-point results among the participants who received study drugs after enrollment and met all inclusion/exclusion criteria. Here, 'n' represents the participants who were evaluable at specific time point.||number of tender joints||Standard Deviation|Mean
678774|NCT01592292|Secondary|Efficacy: Mean Change From Baseline in DAS28 at Month 12|DAS28 is calculated from the number of swollen joints and tender joints using the 28-joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 (minimum score) to 10 (maximum score); higher scores indicated greater affectation due to disease activity. A DAS28 score of less than or equal to (=<) 3.2 = low disease activity, a DAS28 score of >3.2 to 5.1 = moderate to high disease activity.|Baseline and Month 12|Analysis was performed on participants who were administered with secondary biological agent continuously without change or suspension for 12 months. Here, 'n' represents the participants who were evaluable at specific time point.||units on a scale||Standard Deviation|Mean
678775|NCT01592292|Primary|Efficacy: Mean Change From Baseline in DAS28 at Month 6 in Standard Population Set (SPS)|DAS28 is calculated from the number of swollen joints and tender joints using the 28-joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 (minimum score) to 10 (maximum score); higher scores indicated greater affectation due to disease activity. A DAS28 score of less than or equal to (=<) 3.2 = low disease activity, a DAS28 score of >3.2 to 5.1 = moderate to high disease activity.|Baseline and Month 6|The SPS included participants who maintained the secondary biological agent treatment selected for the first time for 6 months among the participants included in the ITT set.||units on a scale||Standard Deviation|Mean
678776|NCT01592292|Primary|Efficacy: Mean Change From Baseline in DAS28 at Month 6 in Intention to Treat (ITT) Population|DAS28 is calculated from the number of swollen joints and tender joints using the 28-joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and patient's global assessment of disease activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 (minimum score) to 10 (maximum score); higher scores indicated greater affectation due to disease activity. A DAS28 score of less than or equal to (=<) 3.2 = low disease activity, a DAS28 score of >3.2 to 5.1 = moderate to high disease activity.|Baseline and Month 6|The ITT set included participants who offered end-point results among participants who received study drugs after enrollment and met all inclusion/exclusion criteria.||units on a scale||Standard Deviation|Mean
678777|NCT01592071|Primary|Waist-Hip Ratio (WHR)|Measure of body composition: hip and waist circumference to calculate waist/hip ratio (WHR).|30, 60 or 90 days from baseline|||ratio||Standard Deviation|Mean
678778|NCT01592071|Primary|Hip Circumference|Measure of body composition: hip circumference (cm).|30, 60 or 90 days from baseline|||centimeters||Standard Deviation|Mean
678779|NCT01592071|Secondary|Quality of Life|Quality of life categories measured with the SF-36 Health Survey. The SF-36 Health Survey provides psychometrically-based physical and mental health summary measures and a preference-based health utility index.The SF-36 provides a t-score for each scale or domain ranging from 0-100 with higher scores representing better perceived quality of life.|30, 60 or 90 days from baseline|||Scores on a scale||Standard Deviation|Mean
678780|NCT01592071|Secondary|Heart Rate|Heart rate measured.|30, 60 and 90 days from baseline|||bpm||Standard Deviation|Mean
678781|NCT01592071|Primary|Waist Circumference|Measure of body composition: waist circumference (cm).|30, 60 and 90 days from baseline|||centimeters||Standard Deviation|Mean
678782|NCT01592071|Primary|Body Mass Index|Measure of body composition: height and weight to assess BMI.|30, 60 and 90 days from baseline|||kg/m^2||Standard Deviation|Mean
678783|NCT01592071|Secondary|Blood Pressure|Systolic and diastolic blood pressure measured.|30, 60 and 90 days from baseline|||mm Hg||Standard Deviation|Mean
678784|NCT01592071|Primary|Weight (kg)|Measure of body composition: weight (kg).|30, 60 and 90 days from baseline|||kilograms||Standard Deviation|Mean
678785|NCT01592045|Primary|Peak Plasma Concentration (Cmax)|"Twenty-two PK samples will be obtained at the following timepoints:
Courses 1 and 3:
Day: 0 Days: 3, 4, 5 and 6: post ch14.18 Days 7:10 to 14 hours post ch14.18 Days 9 to 11: Single sample Days 14 to 17: Single sample
Courses 2 and 4:
Day 0: Pre-IL-2 Day 7: Pre-ch14.18 Day 10 (Course 4 only): Post ch14.18 End of Treatment: Within 2 weeks post isotretinoin"|PK samples obtained during Courses 1 and 3: Days 0, 3, 4, 5, 6, 7, 9, 10, 11, 14, 15, 16, 17; PK samples obtained during Courses 2 and 4: Days 0, 7, 10; End of Treatment|||ng/mL||Standard Deviation|Mean
678786|NCT01592045|Primary|Area Under the Plasma Concentration Curve (AUC)|"Twenty-two PK samples will be obtained at the following timepoints:
Courses 1 and 3:
Day: 0 Days: 3, 4, 5 and 6: post ch14.18 Days 7:10 to 14 hours post ch14.18 Days 9 to 11: Single sample Days 14 to 17: Single sample
Courses 2 and 4:
Day 0: Pre-IL-2 Day 7: Pre-ch14.18 Day 10 (Course 4 only): Post ch14.18 End of Treatment: Within 2 weeks post isotretinoin"|PK samples obtained during Courses 1 and 3: Days 0, 3, 4, 5, 6, 7, 9, 10, 11, 14, 15, 16, 17; PK samples obtained during Courses 2 and 4: Days 0, 7, 10; End of Treatment|||mcg*hr/mL||Standard Deviation|Mean
678787|NCT01592006|Secondary|Safety of Triple Antiviral Therapy in HCV Infected OLT Recipients|Tolerability and Safety will be measured and reported by serious adverse events.|6 years from the start of the study|||participants|||Number
678788|NCT01592006|Primary|The Efficacy of Triple Antiviral Therapy|To evaluate the efficacy of triple antiviral therapy, consisting of pegylated interferon alfa-2a (Pegasys®), ribavirin, and telaprevir therapy in liver transplant recipients with hepatitis C. This will be measured and reported by sustained virologic response (defined as undetectable HCV RNA in the blood 24 weeks after completing therapy [SVR24])|3 years from start of study|||percentage of participants|||Number
678789|NCT01591954|Secondary|Data Recording for Retrospective Analysis|"The secondary outcome variable of this study is the data recorded by the video augmentation system during pertinent portions of the operation. We will be targeting steps in the procedure that would have the greatest benefit from an augmented video scene to be used later for further studies. Such data will form the subject of retrospective analysis of workflow.
Three sets of data will be collected to be able to reconstruct the video scene for analysis of the system:
- Tracked Endoscope information.
- Video from endoscopy
- Planning CT/MRI data"|Data is recorded during case.|The study was terminated following 1 subject accrual. The system encountered basic software incompatibility and would not function reliably. The problem could not be resolved even with extensive technical troubleshooting, so the study was terminated. Data was collected for one participant but could not be analyzed due to software incompatibility.|||||
678790|NCT01591954|Primary|Qualitative Assessment of Video Augmentation Software by Post-operative Survey of Neurosurgeon and Otolaryngologist|"The qualitative assessment of new video augmentation software by the three surgeons surveys the effect of video augmentation overlay on overall surgical confidence, procedure, approach, and visualization.
= Significant hindrance / Negative effect;
= Minor hindrance / Slightly negative effect;
= Not helpful / No benefit or hindrance;
= Somewhat helpful / Slight benefit;
= Very helpful / Major benefit. Evaluation of safety is determined by collecting data regarding additional time, personnel and possible contamination."|Assessment is immediate, following operation.|The study was terminated following 1 subject accrual. The system encountered basic software incompatibility and would not function reliably. The problem could not be resolved even with extensive technical troubleshooting, so the study was terminated. Data was collected for one participant but could not be analyzed due to software incompatibility.|||||
678791|NCT01591863|Primary|Investigate Concentrations of the Main Metabolite OP-1118 in Fecal Samples.|End of therapy fecal levels of OP-1118 (mean)|End of Therapy; Day 10-11|Treated subjects with evaluable fecal data||microgram/g||Standard Deviation|Mean
678792|NCT01591863|Primary|Investigate Concentrations of the Main Metabolite OP-1118 in Plasma Samples.|3-5 hour plasma levels of OP-1118 (mean)|3-5 hours after administration|Treated subjects with evaluable plasma pharmacokinetic data||ng/mL||Standard Deviation|Mean
678793|NCT01591863|Secondary|Evaluate the Clinical Outcome by Assessment of Sustained Clinical Response.|Positive clinical response without recurrence through the follow-up period|28 days post-treatment|Treated subjects with positive toxin assay result within 24 hours of enrollment||percentage of participants||95% Confidence Interval|Number
678794|NCT01591863|Secondary|Evaluate the Clinical Outcome by Assessment of Clinical Response.|Positive clinical response defined as resolution of diarrhea|Day 10|Treated subjects with positive toxin assay result within 24 hours of enrollment||percentage of subjects||95% Confidence Interval|Number
678795|NCT01591863|Primary|Investigate Concentrations of Fidaxomicin in Fecal Samples.|End of therapy fecal levels of fidaxomicin (mean)|End of Therapy; Day 10-11|Treated subjects with evaluable fecal data||microgram/g||Standard Deviation|Mean
678796|NCT01591863|Primary|Investigate Concentrations of Fidaxomicin in Plasma Samples.|3-5 hour plasma levels of fidaxomicin (mean)|3-5 hours after administration|Treated subjects with evaluable plasma pharmacokinetic data||ng/mL||Standard Deviation|Mean
678797|NCT01591863|Primary|Number of Participants With Adverse Events.|Number of participants with adverse events, as categorized by MedDRA.|Enrollment through end of study (Day 38-41)|Subjects receiving any amount of study drug||participants|||Number
678798|NCT01591837|Secondary|Frequency of Any Unsolicited AEs.|The percentage of participants reporting any unsolicited AEs. Unsolicited AEs included AEs other than those specifically solicited.|After vaccination until the end of the study; approximately 21 days|The Safety Population included all participants who received CSL Influenza Vaccine and provided follow-up safety data.||percentage of participants|||Number
678799|NCT01591837|Secondary|Frequency and Intensity of Any Solicited Adverse Events (AEs).|"The percentage of participants reporting any solicited AEs and the percentage of participants reporting any solicited AEs with severe intensity. Note: Intensity of solicited AEs was collected for temperature only.
Solicited local AEs collected included induration >50 mm, erythema, ecchymosis, and pain at the vaccination site.
Solicited systemic AEs collected included temperature above 38.0°C, chills, and malaise.
Solicited AE intensity grading: Mild: symptoms were easily tolerated and there was no interference with daily activities; Moderate: enough discomfort to cause some interference with daily activities; Severe: symptoms that prevented normal, everyday activities."|During the 4 days after vaccination (Day 0 plus 3 days)|The Safety Population included all participants who received CSL Influenza Vaccine and provided follow-up safety data.||percentage of participants|||Number
679003|NCT01589510|Secondary|Percentage of Patients Who Continue Lumigan® 0.01% Treatment|Patients who will continue Lumigan® 0.01% after 14 weeks of treatment was assessed as Yes or No.|Week 14|All patients||Percentage of Patients|||Number
678800|NCT01591837|Primary|The Percentage of Evaluable Participants Achieving a HI Titre ≥ 40 or Single Radial Haemolysis (SRH) Area ≥ 25 mm2.|For the H1N1, H3N2, and B influenza virus strains. Note: No SRH data were collected.|Approximately 21 days after vaccination|The Evaluable Population included all participants who were vaccinated with CSL Influenza Vaccine, provided both pre- and post-vaccination antibody titer results, did not use a prohibited medication as per the protocol, and were not excluded from the analysis according to the elimination criteria.||percentage of participants||95% Confidence Interval|Number
678801|NCT01591837|Primary|The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination.|GMFI (H1N1, H3N2, and B influenza virus strains) was defined as the geometric mean of the fold increases of post-vaccination antibody titre over the pre-vaccination antibody titre.|Approximately 21 days after vaccination|The Evaluable Population included all participants who were vaccinated with CSL Influenza Vaccine, provided both pre- and post-vaccination antibody titer results, did not use a prohibited medication as per the protocol, and were not excluded from the analysis according to the elimination criteria.||geometric mean fold increase||95% Confidence Interval|Geometric Mean
678802|NCT01591837|Primary|The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre.|As per the criteria specified in the CPMP/BWP/214/96 Note for Guidance on Harmonisation of Requirements for Influenza Vaccines. For haemagglutination inhibition (HI), seroconversion (H1N1, H3N2, and B influenza virus strains) was defined as achieving a post-vaccination titre of ≥ 40 for those participants with a pre-vaccination HI titre of < 10. A significant increase (H1N1, H3N2, and B influenza virus strains) was defined as a four-fold or greater increase in HI titre for those participants with a pre-vaccination HI titre of ≥ 10.|Approximately 21 days after vaccination|The Evaluable Population included all participants who were vaccinated with CSL Influenza Vaccine, provided both pre- and post-vaccination antibody titer results, did not use a prohibited medication as per the protocol, and were not excluded from the analysis according to the elimination criteria.||percentage of participants||95% Confidence Interval|Number
678803|NCT01591681|Secondary|Percent of Nights With Sensor Glucose >250 mg/dL||Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use|||percentage of nights|Participants||Number
678804|NCT01591681|Secondary|Overnight Area Under the Curve 250 mg/dl Per 8 Hour|The measure is reporting area under the curve for glucose concentrations below 250 mg/dL and above 60 mg/dL. Overall time below and above a threshold and area under a curve was divided by total time and multiplied by 8 hours.|Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use|||mg*hr/dL|Participants|Inter-Quartile Range|Median
678805|NCT01591681|Secondary|Overall Mean Sensor Glucose Overnight|Calculated as the median of the overall mean.|Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use|||mg/dl|Participants|Inter-Quartile Range|Median
678806|NCT01591681|Secondary|Percent of Mornings With Urine Ketones >/= 15 mg/dl|Urine ketones measured each morning with Ketostix.|42 mornings following night of system use|||percentage of mornings|Participants||Number
678807|NCT01591681|Secondary|Percent of Mornings With Blood Ketones >1.0 mmol/L|Blood ketones measured with a study blood ketone meter.|42 mornings following night of system use|||percentage of mornings|Participants||Number
678808|NCT01591681|Secondary|Percent of Mornings With Glucose >250 mg/dL|Measured with a study home blood glucose meter.|42 mornings following night of system use|||percentage of mornings|Participants||Number
678809|NCT01591681|Secondary|Median Morning Blood Glucose|Measured with a study home blood glucose meter.|42 mornings following night of system use|||mg/dl|Participants|Inter-Quartile Range|Median
678810|NCT01591681|Secondary|Proportion of Nights With a Sensor Glucose Value </= 50 mg/dL||Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use|||percentage of nights|Participants||Number
678811|NCT01591681|Secondary|Percentage of Nights With a Sensor Glucose Value </= 70 mg/dL||Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use|||percentage of nights|Participants||Number
678812|NCT01591681|Secondary|Percentage of Sensor Glucose Values 71 to 180 mg/dL|The median percentages of the number of glucose values with values of 71-180 mg/dL overall.|Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use|||percentage glucose values|Participants|Inter-Quartile Range|Median
678813|NCT01591681|Primary|Hypoglycemia Outcome: Percentage of Nights With Sensor Glucose Value </=60 mg/dl|Each night is categorized as to whether hypoglycemia occurred. Hypoglycemia is defined as the occurrence of one or more CGM glucose values ≤60 mg/dL. The percentage of hypoglycemic nights will be tabulated separately with versus without the closed-loop control system in use. A repeated measures logistic regression model will be used to compare intervention versus control nights accounting for correlated data from the same subject and adjusting for the baseline (bedtime) sensor glucose.|Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use|||percentage of nights|Participants||Number
678814|NCT01591616|Secondary|ECGs (QTcB Interval)|Ventricular heart rate, PR interval, QRS duration, QT interval, and QTcB intervals were calculated.|Pre-dose, 1 hour, 2 hour, 4 hour post-dose.|||milliseconds||Standard Deviation|Mean
678815|NCT01591616|Secondary|ECGs (QT Interval)|Ventricular heart rate, PR interval, QRS duration, QT interval, and QTcB intervals were calculated.|Pre-dose, 1 hour, 2 hour, 4 hour post-dose.|||milliseconds||Standard Deviation|Mean
678816|NCT01591616|Secondary|ECGs (QRS Duration)|Ventricular heart rate, PR interval, QRS duration, QT interval, and QTcB intervals were calculated.|Pre-dose, 1 hour, 2 hour, 4 hour post-dose.|||milliseconds||Standard Deviation|Mean
678817|NCT01591616|Secondary|ECGs (PR Interval)|Ventricular heart rate, PR interval, QRS duration, QT interval, and QTcB intervals were calculated.|Pre-dose, 1 hour, 2 hour, 4 hour post-dose.|||milliseconds||Standard Deviation|Mean
678818|NCT01591616|Secondary|ECGs (Ventricular Heart Rate)|Ventricular heart rate, PR interval, QRS duration, QT interval, and QTcB intervals were calculated.|Pre-dose, 1 hour, 2 hour, 4 hour post-dose.|||Beats per minute||Standard Deviation|Mean
678819|NCT01591616|Secondary|Vital Signs (Diastolic Pressure)||Pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose|||mmHg||Standard Deviation|Mean
678820|NCT01591616|Secondary|Vital Signs (Systolic Pressure)||Pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.|||mmHg||Standard Deviation|Mean
678822|NCT01591616|Primary|Pharmacokinetics|The study focused on the pharmacokinetics of prilocaine and lidocaine, o-toluidine (metabolite of prilocaine) and 2, 6-xylidine (metabolite of lidocaine). We evaluated blood samples of15 subjects at the following time points: pre-dose, at 5,10,15,30, 60, 90, 120 and 240 min post dose. We calculated Cmax (maximum observed plasma concentration) and Tmax (time to maximum plasma concentration).|5, 10, 15, 30, 60, 90, 120, and 240 minutes|||hours||Full Range|Geometric Mean
678823|NCT01591616|Secondary|Safety|"The % MetHb levels and vital signs (pulse, systolic and diastolic pressure) were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
ECG taken at pre-dose and 1, 2 and 4h post dose, measurement of heart rate and PR, QRS, QT and QTcB intervals.
Visual analogue scale conducted at pre-dose (immediately before Oraqix administration), immed. post extraction, at 0.25, 0.5, 1 and 2h post dose and prior to discharge just after 4h post dose.
For each subject, phone call was made at +24h as follow up pursuant to the protocol."|blood draws pre-dose, 2 and 4 hours postdose|||Percentage MetHb||Standard Deviation|Mean
678824|NCT01591616|Primary|Pharmacokinetics|The study focused on the pharmacokinetics of prilocaine and lidocaine, o-toluidine (metabolite of prilocaine) and 2, 6-xylidine (metabolite of lidocaine). We evaluated blood samples of15 subjects at the following time points: pre-dose, at 5,10,15,30, 60, 90, 120 and 240 min post dose. We calculated Cmax (maximum observed plasma concentration) and Tmax (time to maximum plasma concentration).|5, 10, 15, 30, 60, 90, 120, and 240 minutes|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
678825|NCT01591499|Secondary|Lens Preference - Ophthalmologist|"Ophthalmologists preference in terms of lenses rated by questionnaire with a limited selected response. (“Choice of Lens? First pair of lenses, Second pair of lenses”) (Biofinity, Air Optix, or Purevision)
Measured at completion of V5 (lens pair two evaluation). Both lenses have been worn. Total time since base line is 34-48 days."|Measured at 17-24 days V3 or V5|(Participant Flow: Biofinity Multifocal/Air Optix Aqua Multifocal N=70, 8 missing values; Biofinity Multifocal/Purevision Multifocal N=68, 8 missing values; Evaluated at least one lens N=138, 16 missing values.)||percentage of investigators|Participants||Number
678826|NCT01591499|Secondary|Lens Preference - Participant|"The number of participants who preferred a lens pair rated by diary questionnaire with a limited selected response.(“Which pair of lenses did you prefer? The first pair, the second pair). Reported per lens.
Measured at completion of V5 (lens pair two evaluation). Both lenses have been worn. Total time since base line is 34-48 days."|Measured at V5|(Participant Flow: Biofinity Multifocal/Air Optix Aqua Multifocal N=70, 8 missing values; Biofinity Multifocal/Purevision Multifocal N=68, 7 missing values; Evaluated at least one lens N=138, 15 missing values.)||percentage of participants|||Number
678827|NCT01591499|Secondary|Clinical Performance - Lens Wettability|"The ophthalmologist’s rating of lens wettability by questionnaire as a limited selected response (Zero, Low, Acceptable, Good or Excellent). Assessed with the slit lamp and reported per lens.
Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):
V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Measured at 17-24 days V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 6 missing values; Air Optix Aqua Multifocal N=70, 5 missing values; Purevision Multifocal N=68, 5 missing values)||percentage of investigators|||Number
678828|NCT01591499|Secondary|Geometric Performance - Lens Mobility|"The ophthalmologist’s rating of lens movement during blinking by questionnaire as a limited selected response (Optimal, Acceptable with a tendency to be tight, Acceptable with a tendency to be Flat, Unacceptable and too tight, or Unacceptable too flat). Assessed with the slit-lamp and reported per lens.
Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):
V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Measured at 17-24 days V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 6 missing values; Air Optix Aqua Multifocal N=70, 5 missing values; Purevision Multifocal N=68, 5 missing values)||Investigators|||Number
678829|NCT01591499|Secondary|Geometric Performance - Lens Centration|"Description: The ophthalmologist’s rating of lens centration during “Focus” and “Shift When Blinking” by questionnaire as a limited selected response (Optimal, Decentration Acceptable or Decentration Unacceptable). Assessed with the slit lamp and reported per lens.
Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):
V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Measured at V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 12 missing values; Air Optix Aqua Multifocal N=70, 9 missing values; Purevision Multifocal N=68, 6 missing values)||Investigators|||Number
678830|NCT01591499|Secondary|Comfort of Use - Average Wearing Time|"The average numbers of hours per day of lens wear by patient. Reported per lens. Calculated by number of hours worn.
Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):
V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two Patients’ subjective rating for lens comfort of use by patient diary and reported per lens. (Average Wearing Time in hours per day)"|Measured at V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 11 missing values; Air Optix Aqua Multifocal N=70, 10 missing values; Purevision Multifocal N=68, 4 missing values)||hours/day||Standard Deviation|Mean
678831|NCT01591499|Secondary|Subjective Rating of Lens Comfort - General Comfort|"Patients’ subjective rating for lens comfort by patient diary and reported per lens. (General Comfort, Scale 0-100, 0=very uncomfortable, 100=very comfortable).
Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):
V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Measured at V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 7 missing values; Air Optix Aqua Multifocal N=70, 5 missing values; Purevision Multifocal N=68, 4 missing values)||units on a scale||Standard Deviation|Mean
678832|NCT01591499|Secondary|Subjective Rating of Lens Comfort - End of Day|"Patients’ subjective rating for lens comfort by patient diary and reported per lens. (At End of Day, Scale 0-100, 0=very uncomfortable, 100=very comfortable).
Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):
V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Measured at V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 7 missing values; Air Optix Aqua Multifocal N=70, 5 missing values; Purevision Multifocal N=68, 5 missing values)||units on a scale||Standard Deviation|Mean
678970|NCT01589978|Secondary|Target Vessel Failure (TVF) Rate|"Target vessel failure (TVF) is defined as any revascularization of the target vessel, myocardial infarction (MI) related to the target vessel, or death related to the target vessel.
For the purposes of this protocol, if it cannot be determined with certainty whether MI or death was related to the target vessel it will be considered TVF."|≤24 hours, 30 days, 180 days, annually through 5 years|||percentage of patients|||Number
678833|NCT01591499|Secondary|Subjective Rating of Lens Comfort - During Day|"Patients’ subjective rating for lens comfort by patient diary and reported per lens. (During the Day, Scale 0-100, 0=very uncomfortable, 100=very comfortable).
Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):
V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Measured at V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 7 missing values; Air Optix Aqua Multifocal N=70, 5 missing values; Purevision Multifocal N=68, 4 missing values)||units on a scale||Standard Deviation|Mean
678834|NCT01591499|Secondary|Subjective Rating of Lens Comfort, Fitting|"Patients' subjective rating for lens comfort by patient diary and reported per lens. (After lens fitting, Scale 0-100, 0=very uncomfortable, 100=very comfortable).
Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):
V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Measured at V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 7 missing values; Air Optix Aqua Multifocal N=70, 5 missing values; Purevision Multifocal N=68, 5 missing values)||units on a scale||Standard Deviation|Mean
678835|NCT01591499|Secondary|Visual Performance - Near Stereoscopic Vision|"The mean number of occurrences where the “number of the last figure where the patient equipped with analyzers can make out the raised circle (from number 1 to 9),” performed at a distance of 40 centimeters, using Wirt Vectographic Stereopsis Test. Reported per lens.
Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):
V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Measured at V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 10 missing values; Air Optix Aqua Multifocal N=70, 7 missing values; Purevision Multifocal N=68, 4 missing values)||number of occurrances||Standard Deviation|Mean
678836|NCT01591499|Secondary|Visual Performance: Distance, High Contrast Vision|"The number of letters read at a distance of 5 meters under 90% high contrast. Measured by objective assessment and reported per lens. Rated on a visual chart (La Galinet- number of letters read).
Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):
V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Measured at V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 5 missing values; Air Optix Aqua Multifocal N=70, 5 missing values; Purevision Multifocal N=68, 4 missing values)||number of letters read||Standard Deviation|Mean
678837|NCT01591499|Secondary|Visual Performance: Distance, Low Contrast Vision|"The number of letters read at a distance of 5 meters under 10% low contrast. Measured by objective assessment and reported per lens. Rated on a visual chart (La Galinet- number of letters read).
Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):
V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Measured at V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 4 missing values; Air Optix Aqua Multifocal N=70, 4 missing values; Purevision Multifocal N=68, 4 missing values)||number of letters read||Standard Deviation|Mean
678838|NCT01591499|Secondary|Visual Performance: Near, High Contrast Vision|"The number of letters read at a near of 40 centimeters under 90% high contrast. Measured by objective assessment and reported per lens. Rated on a visual chart (La Galinet- number of letters read).
Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):
V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Measured at 17-24 days V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 4 missing values; Air Optix Aqua Multifocal N=70, 4 missing values; Purevision Multifocal N=68, 4 missing values)||number of letters read||Standard Deviation|Mean
678839|NCT01591499|Secondary|Visual Performance - Near, Low Contrast Vision|"The number of letters read at a near of 40 centimeters under 10% low contrast. Measured by objective assessment and reported per lens. Rated on a visual chart (La Galinet- number of letters read).
Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):
V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Measured at V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 4 missing values; Air Optix Aqua Multifocal N=70, 4 missing values; Purevision Multifocal N=68, 4 missing values)||number of letters read||Standard Deviation|Mean
678840|NCT01591499|Secondary|Visual Performance - Quality of Distance Vision|"Patients' subjective rating for quality of distance vision by patient diary and reported per lens. (driving, looking at a landscape, etc. 0-100, 0=totally blurred, 100=perfectly clear).
Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):
V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Measured at 17-24 days V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 4 missing values; Air Optix Aqua Multifocal N=70, 3 missing values; Purevision Multifocal N=68, 2 missing values)||units on a scale||Standard Deviation|Mean
678841|NCT01591499|Secondary|Visual Performance - Quality of Intermediate Vision|"Patients' subjective rating for quality of intermediate vision by patient diary and reported per lens. (distance equivalent to an arm's length. 0-100, 0=totally blurred, 100=perfectly clear).
Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):
V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Measured at V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 3 missing values; Air Optix Aqua Multifocal N=70, 3 missing values; Purevision Multifocal N=68, 3 missing values)||units on a scale||Standard Deviation|Mean
678842|NCT01591499|Secondary|Visual Performance - Quality of Near Vision|"Patients' subjective rating for quality of near vision by patient diary and reported per lens. (40cm away: reading a newspaper, looking at your watch etc. 0-100, 0=totally blurred, 100=perfectly clear).
Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):
V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Measured at V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 3 missing values; Air Optix Aqua Multifocal N=70, 3 missing values; Purevision Multifocal N=68, 2 missing values)||units on a scale||Standard Deviation|Mean
678843|NCT01591499|Secondary|Visual Performance - Distance Visual Acuity|"Description: The participant’s distance binocular visual acuity (at 5 meters) using the La Galinet method. (Decimal scale, Excellent=between 5 and 20 tenths at 5 metres and between 1 and 20 tenths at 40 cm)
Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):
V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Measure at V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 5 missing values; Air Optix Aqua Multifocal N=70, 6 missing values; Purevision Multifocal N=68, 6 missing values)||decimal units on a scale||Standard Deviation|Mean
678971|NCT01589978|Secondary|Rate of Cardiac Death or Myocardial Infarction Events Related to the PROMUS Element Stent|See individual descriptions of events.|≤24 hours, 30 days, 180 days, annually through 5 years|||percentage of patients|||Number
678844|NCT01591499|Primary|Visual Performance - Comparison of Initial Refraction to Multifocal Lenses|"The percentage of participants who obtained binocular distance and near visual acuities (VA) at least as good as their initial refraction assessment. Measured by Initial Refraction. Distance binocular VA (at 5 meters) using the Snellen chart decimal scale and near binocular VA (at 40 cm) using the Parinaud chart (smallest to largest letters, Score P1.5, P2, P4, P5).
Change over time measured at V1 (initial refraction) and at V3 (lens pair one evaluation) and V5 (lens pair two evaluation):
V1 = initial refraction at baseline, V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Change over time measured at V1, V3 and V5|"Percentage of patients who obtained distance and near binocular visual acuities at least as good as their initial refraction visual acuities.
(Participant Flow: Biofinity Multifocal N=138, 14 missing values; Air Optix Aqua Multifocal N=70, 12 missing values; Purevision Multifocal N=68, 13 missing values)"||percentage of participants|||Number
678845|NCT01591499|Secondary|Visual Performance - Near Visual Acuity|"Description: The participant’s near binocular visual acuity (at 40 cm) using the Parinaud chart (smallest to largest letters, Score P1.5, P2, P4, P5) and reported per lens.
Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):
V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Measured at V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 4 missing values; Air Optix Aqua Multifocal N=70, 8 missing values; Purevision Multifocal N=68, 8 missing values)||participants|||Number
678846|NCT01591460|Secondary|Percentage of Participants Using Concomitant Medications During Treatment and Follow-Up|Use of concomitant prescription or nonprescription medications during the 48-week treatment period and/or within 24 weeks of follow-up was documented. The percentage of participants using concomitant medications was calculated as [number of participants reporting concomitant use divided by the number of participants analyzed] multiplied by 100. Medication classes reported by >10% of participants included analgesics, nonsteroidal anti-inflammatory drugs (NSAIDs), antihistamines, corticosteroids, proton pump inhibitors, vitamins and minerals, and beta-adrenoceptor blocking agents as reported here.|Up to 72 weeks (from Baseline until 24 weeks after EOT)|Safety Population.||percentage of participants|||Number
678847|NCT01591460|Secondary|Percentage of Participants With a Concomitant Disease Prior to or During the Study|The prevalence of concomitant disease at any time from Screening through the end of follow-up was documented. The percentage of participants with a concomitant disease was calculated as [number of participants reporting or diagnosed with concomitant disease divided by the number of participants analyzed] multiplied by 100. Diseases documented for ≥5% of participants included hypertension, diabetes mellitus, hypothyroidism, and vitamin D deficiency as reported here.|Up to 76 weeks (from Screening until 24 weeks after EOT)|Safety Population.||percentage of participants|||Number
678848|NCT01591460|Secondary|Percentage of Participants Using Concomitant Hematopoietic Stimulants During Treatment and Follow-Up|Use of concomitant hematopoietic stimulants (such as epoetin) during the 48-week treatment period and/or within 24 weeks of follow-up was documented. The percentage of participants using concomitant hematopoietic stimulants was calculated as [number of participants reporting concomitant use divided by the number of participants analyzed] multiplied by 100.|Up to 72 weeks (from Baseline until 24 weeks after EOT)|Safety Population.||percentage of participants|||Number
678849|NCT01591460|Secondary|Time to Safety-Related Dose Modification|Dose modifications for each study drug included any dose reduction, treatment interruption, or premature withdrawal. Median time to safety-related dose modification (eg, modification due to adverse event or laboratory abnormality) of any study drug was estimated using Kaplan-Meier and expressed in weeks.|Up to 48 weeks (from Baseline until EOT)|Safety Population.||weeks||95% Confidence Interval|Median
678850|NCT01591460|Secondary|Number of Participants With a Safety-Related Dose Modification|Dose modifications for each study drug included any dose reduction, treatment interruption, or premature withdrawal. The percentage of participants with a safety-related dose modification (eg, modification due to adverse event or laboratory abnormality) of any study drug was calculated as [number of participants with dose modification divided by the number of participants analyzed] multiplied by 100.|Up to 48 weeks (from Baseline until EOT)|Safety Population.||participants|||Number
678851|NCT01591460|Secondary|Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir|The frequency of missed treatments was examined using the number of administrations received as a percentage of target administrations for each study drug. The maximum number of possible administrations was considered in terms of once-weekly injections with PEG-IFN and in terms of treatment days with RBV and boceprevir. The percentage of target administrations each participant received was separated into ranges of <60%, 60 to <80%, 80 to <95%, and ≥95% for each study drug. The percentage of participants who received each range of target administrations was calculated as [number of participants in each range divided by the number of participants analyzed] multiplied by 100.|Up to 48 weeks (from Baseline until EOT)|Safety Population; only participants providing evaluable data were included in the analysis. Arms were not mutually exclusive.||percentage of participants|||Number
678852|NCT01591460|Secondary|Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason|Dose modifications for each study drug included any dose reduction, treatment interruption, or premature withdrawal. Adverse event (AE)-related reasons were documented, as well as reasons related to insufficient efficacy ('Poor efficacy') or other safety-related reasons ('Safety/other'). The percentage of participants with a dose modification documented for each reason was calculated as [number of participants with dose modification divided by the number of participants analyzed] multiplied by 100.|Up to 48 weeks (from Baseline until EOT)|Safety Population; n = number of participants who received the respective study medication. Arms were not mutually exclusive.||percentage of participants|||Number
678853|NCT01591460|Secondary|Duration of Treatment With PEG-IFN, RBV, and Boceprevir|The duration of treatment with each study drug was determined as the time from treatment start until the last dose of PEG-IFN, RBV, or boceprevir. Median duration of treatment was determined using the actual duration of treatment among individual participants and expressed in weeks.|Up to 48 weeks (from Baseline until EOT)|Safety Population: All participants who received at least one dose of study medication and had at least one post-baseline safety assessment; n = number of participants who received the respective study medication. Arms were not mutually exclusive.||weeks||Full Range|Median
678972|NCT01589978|Secondary|Cardiac Death or Myocardial Infarction (MI) Rate|See individual descriptions of events.|≤24 hours, 30 days, 180 days, annually through 5 years|||percentage of patients|||Number
678854|NCT01591460|Secondary|Percentage of Participants With Treatment Discontinued Based Upon Elevated (Week 12) or Detectable (Week 24) HCV RNA|Treatment was to be discontinued for participants who met prespecified criteria, termed the futility rule, after 12 or 24 weeks of treatment. Participants were discontinued from treatment for one of the following reasons: HCV RNA viral load ≥100 IU/mL (Week 12) or a detectable HCV RNA viral load (Week 24). HCV RNA viral load was measured using the Roche COBAS TaqMan 2.0 HCV Test, with a lower LOD of 10 to 15 IU/mL. The percentage of participants with treatment discontinued for each reason was calculated as [number of participants meeting one of the above criteria divided by the number of participants analyzed] multiplied by 100.|At 12 and 24 weeks|All-Treated Population. Arms were not mutually exclusive.||percentage of participants|||Number
678855|NCT01591460|Secondary|Percentage of Participants With Virological Rebound Following On-Treatment Decline in HCV RNA|Virological rebound was defined as an HCV RNA viral load >1000 IU/mL and a ≥1-log increase from nadir following a decline in HCV RNA from Baseline at any time during treatment (ie, on-treatment decline). Participants who ultimately achieved an EOT response were not considered for virological rebound. The percentage of participants with virological rebound was calculated as [number of participants meeting the above criteria divided by the number of participants analyzed] multiplied by 100.|Up to 48 weeks (at Baseline; Weeks 2, 4, 6, 8, 12, 16, 24, 28, and 36; and EOT)|All-Treated Population; only participants with a previous on-treatment decline in HCV RNA were included in the analysis. Arms were not mutually exclusive.||percentage of participants||95% Confidence Interval|Number
678856|NCT01591460|Secondary|Percentage of Participants With Virological Breakthrough Following On-Treatment Response|Virological breakthrough was defined as an HCV RNA viral load greater than (>) 1000 IU/mL following a previously undetectable level at any time during treatment (ie, virological response). Participants who ultimately achieved an EOT response were not considered for virological breakthrough. The percentage of participants with virological breakthrough was calculated as [number of participants meeting the above criteria divided by the number of participants analyzed] multiplied by 100.|Up to 48 weeks (at Baseline; Weeks 2, 4, 6, 8, 12, 16, 24, 28, and 36; and EOT)|All-Treated Population; only participants with a previous on-treatment virological response were included in the analysis. Arms were not mutually exclusive.||percentage of participants||95% Confidence Interval|Number
678857|NCT01591460|Secondary|Percentage of Participants With Virological Relapse Following EOT Response|Virological relapse was defined as a detectable post-treatment HCV RNA viral load following a previously undetectable EOT level (ie, virological response). The percentage of participants with virological relapse was calculated as [number of participants meeting the above criteria divided by the number of participants analyzed] multiplied by 100.|Up to 72 weeks (at 12 and 24 weeks after EOT)|All-Treated Population; only participants with a previous EOT virological response were included in the analysis. Arms were not mutually exclusive.||percentage of participants||95% Confidence Interval|Number
678858|NCT01591460|Secondary|Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA|HCV RNA levels were obtained routinely during and after treatment. Reductions in HCV RNA viral load by 1-log, 2-log, or 3-log increments were determined relative to Baseline HCV RNA. Each increment represents a reduction greater than or equal to (≥) the specified log value, including results for which HCV RNA was below the limit of quantification (25 IU/mL). The percentage of participants with each log reduction in HCV RNA was calculated as [number of participants with log reduction divided by the number of participants analyzed] multiplied by 100.|At Weeks 2, 4, 6, 8, 12, 16, 24, and 28|All-Treated Population. Arms were not mutually exclusive.||percentage of participants||95% Confidence Interval|Number
678859|NCT01591460|Secondary|Percentage of Participants With Virological Response|HCV RNA levels were obtained routinely during and after treatment. The percentage of participants with undetectable HCV RNA viral load (ie, virological response) was calculated as [number of participants with undetectable HCV RNA at each timepoint divided by the number of participants analyzed] multiplied by 100.|At Weeks 2, 4, 6, 8, 12, 16, 24, 28, and 36; and EOT (up to 48 weeks)|All-Treated Population. Arms were not mutually exclusive.||percentage of participants||95% Confidence Interval|Number
678860|NCT01591460|Secondary|HCV RNA Levels|HCV RNA levels were obtained routinely during and after treatment. Mean HCV RNA levels were calculated by averaging the HCV RNA levels among all participants analyzed at each collection timepoint and expressed in log10 IU/mL.|At Baseline; Weeks 2, 4, 6, 8, 12, 16, 24, 28, and 36; EOT; and 12 and 24 weeks after EOT (up to 72 weeks)|All-Treated Population; number (n) = number of participants who provided evaluable data at the respective visit. Arms were not mutually exclusive.||log10 IU/mL||Standard Deviation|Mean
678861|NCT01591460|Secondary|Percentage of Participants With SVR at 24 Weeks After EOT|SVR at 24 weeks after EOT was defined as an undetectable HCV RNA viral load obtained 24 weeks following completion of treatment. HCV RNA viral load was measured using the Roche COBAS TaqMan 2.0 HCV Test, with a lower LOD of 10 to 15 IU/mL. The percentage of participants with SVR was calculated as [number of participants with undetectable HCV RNA at 24 weeks after EOT divided by the number of participants analyzed] multiplied by 100.|At 24 weeks after EOT (up to 72 weeks)|All-Treated Population. Arms were not mutually exclusive.||percentage of participants||95% Confidence Interval|Number
678862|NCT01591460|Primary|Percentage of Participants With Sustained Virological Response (SVR) at 12 Weeks After End of Treatment (EOT)|SVR at 12 weeks after EOT was defined as an undetectable HCV RNA viral load obtained 12 weeks following completion of treatment. HCV RNA viral load was measured using the Roche COBAS TaqMan 2.0 HCV Test, with a lower limit of detection (LOD) of 10 to 15 international units per milliliter (IU/mL). The percentage of participants with SVR was calculated as [number of participants with undetectable HCV RNA at 12 weeks after EOT divided by the number of participants analyzed] multiplied by 100.|At 12 weeks after EOT (up to 60 weeks)|All-Treated Population. Arms were not mutually exclusive.||percentage of participants||95% Confidence Interval|Number
678863|NCT01591408|Primary|Improved Symptom Ratings|"Will test whether subjects receiving real EEG biofeedback report decreased anxiety and irritability relative to subjects receiving sham biofeedback. The scale for each rating was a 0-10, with 0 meaning not at all and 10 being extremely anxious/irritable."|4 weeks|Subjects were active duty military with PTSD diagnosis currently in residential treatment facility||Rating on scale||Standard Deviation|Mean
678973|NCT01589978|Secondary|Rate of Target Vessel Revascularization (TVR) Events Related to the PROMUS Element Stent|Target vessel revascularization is defined as any attempted or successfully completed percutaneous or surgical revascularization of a target vessel.|≤24 hours, 30 days, 180 days, annually through 5 years|||percentage of patients|||Number
678864|NCT01591382|Secondary|Number of Participants With Treatment Related Adverse Events (AEs)|Participants were asked to complete a “Side Effects Checklist” to assess for any unwanted side effects (AEs) of drugs that were administered. The determination of whether or not an AE was treatment related was at the discretion of the Investigator.|Participants were followed for the duration of hospital stay, an average of approximately 3 days.|All randomized participants who completed the study and also completed the Side Effects Checklist.||participants|||Number
678865|NCT01591382|Secondary|24-Hour Postoperative Opioid Use|Opioid use is defined as the total milligrams of hydromorphone plus other home or oral opioid used per 24 hours, converted to oral morphine equivalents.|For 24 hours following surgery|All randomized participants who completed the study.||oral morphine mg equivalents||Standard Deviation|Mean
678866|NCT01591382|Secondary|Least Postoperative Pain Score|Postoperative pain scores were collected once per day during morning rounds for the preceding 24 hours. Participant were asked to provide pain scores for “worst,” “average,” and “least” pain using the 11-point Numerical Rating Scale (NRS), where 0 represents the absence of pain and 10 is worst possible pain. The average least postoperative pain score for each treatment arm is reported.|Participants were followed for the duration of hospital stay, an average of approximately 3 days.|All randomized participants who completed the study.||units on a scale||Standard Deviation|Mean
678867|NCT01591382|Secondary|Worst Postoperative Pain Score|Postoperative pain scores were collected once per day during morning rounds for the preceding 24 hours. Participant were asked to provide pain scores for “worst,” “average,” and “least” pain using the 11-point Numerical Rating Scale (NRS), where 0 represents the absence of pain and 10 is worst possible pain. The average worst postoperative pain score for each treatment arm is reported.|Participants were followed for the duration of hospital stay, an average of approximately 3 days.|All randomized participants who completed the study.||units on a scale||Standard Deviation|Mean
678868|NCT01591382|Primary|Average Postoperative Pain Score|Postoperative pain scores were collected once per day during morning rounds for the preceding 24 hours. Participant were asked to provide pain scores for “worst,” “average,” and “least” pain using the 11-point Numerical Rating Scale (NRS), where 0 represents the absence of pain and 10 is worst possible pain. The average postoperative pain score for each treatment arm is reported.|Participants were followed for the duration of hospital stay, an average of approximately 3 days.|All randomized participants who completed the study.||units on a scale||Standard Deviation|Mean
678869|NCT01591317|Secondary|Percent Inhibition of Verify Now (VN)-P2Y12 Reaction Units (PRU)|PRU device reported VerifyNow percent inhibition is reported by Accumetrics VerifyNow™ P2Y12 (VN-P2Y12) assay, a point-of-care device that measures platelet aggregation with single-use, disposable cartridges|Predose up to 24 hours post dose on Day 12|All randomized participants||Percent inhibition of PRU||Standard Deviation|Mean
678870|NCT01591317|Primary|Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of Prasugrel's Active Metabolite R-138727 During Maintenance Dose||Day 11 predose to 24 hours post dose|All randomized participants||hours||Full Range|Median
678871|NCT01591317|Primary|Pharmacokinetics (PK): Maximum Concentration (Cmax) for Prasugrel's Active Metabolite R-138727 During Maintenance Dose||Day 11 predose to 24 hours post dose|All randomized participants||ng/mL||Geometric Coefficient of Variation|Geometric Mean
678872|NCT01591317|Primary|Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of Prasugrel's Active Metabolite R-138727 During Maintenance Dose|AUC from time zero to the last quantifiable plasma concentration (tlast)|Day 11 predose to 24 hours post dose|All randomized participants||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
678873|NCT01591317|Secondary|Pharmacodynamics: Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-mediated Platelet Aggregation|ADP-induced PRU represents the rate and extent of ADP-stimulated platelet aggregation and serves as a biomarker of clinical efficacy, with lower values indicating greater P2Y12 platelet inhibition|Predose up to 24 hours post dose on Day 12|All randomized participants||PRU||Standard Deviation|Mean
678874|NCT01591317|Primary|Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of Prasugrel's Active Metabolite R-138727 During Loading Dose||Day 1 predose up to 24 hours post dose|All randomized participants||hours||Full Range|Median
678875|NCT01591317|Primary|Pharmacokinetics (PK): Maximum Concentration (Cmax) for Prasugrel's Active Metabolite R-138727 During Loading Dose||Day 1 predose up to 24 hours post dose|All randomized participants||nanogram/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
678876|NCT01591317|Primary|Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of Prasugrel's Active Metabolite R-138727 During Loading Dose|AUC from time zero to the last quantifiable plasma concentration (tlast)|Day 1 predose up to 24 hours post dose|All randomized participants||nanogram times hour/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
678877|NCT01591044|Primary|Change in FEV1|Change from baseline in pre-BD FEV1 (% predicted) at Week 8.|Baseline and Week 8|All efficacy endpoints were analyzed based on the intent to treat population consisting of all randomized patients.||percentage of change||Standard Deviation|Mean
678878|NCT01591018|Secondary|Number of Participants With Clinical Manifested Brain Infarction|to demonstrate an effect of sonolysis on the reduction of risk of clinically stroke due to the activation of endogenous fibrinolytic system during cardiac surgery|30 days after intervention|All enrolled participants were analyzed||participants|||Number
678879|NCT01591018|Secondary|Cognitive Decline|"To demonstrate an effect of sonolysis on the reduction of cognitive decline after cardiac surgery measured by ACE-R.
Adenbook´s cognitive examination - revised (ACE-R) can aquire value 0 to 100. Higher value represents better cognitive functions."|30 days after intervention|"50 out of 60 participants completed all cognitive tests in cardiac surgery with sonolysis group.
50 out of 60 participants completed all cognitive tests in cardiac surgery without sonolysis group."||units on a scale||Inter-Quartile Range|Median
678880|NCT01591018|Primary|Number od Participants With New Brain Infarction in the Monitored MCA Territory Detected Using MRI|to demonstrate a twenty-percent risk reduction of number and volume of brain infarctions and brain infarctions > 0.5 cm3 in the monitored MCA territory in sonolysis group detected using MRI examination 24 hours after cardiac surgery in 5% level of statistical significance|24 hours after intervention|||participants|||Number
678881|NCT01591005|Other Pre-specified|Number of Participants With Complications|Any complication during carotid endarterectomy and carotid stenting, sonolysis or 30 days after intervention in all subgroups.|24 hours and 30 days after intervention|||participants|||Number
678882|NCT01591005|Secondary|Number of Participants With Clinical Vascular Event or Death|"The risk of the occurrence of death, any stroke, or myocardial infarction within 30 days (myocardial infarction was defined as a post-interventional cardiac troponin T level increase >2-fold the upper limit of normal in addition to either chest pain or symptoms consistent with ischemia or electrocardiographic evidence of ischemia) after carotid endarterectomy and carotid stenting using periprocedural sonolysis.
Substudy: The risk of the occurrence of death, any stroke, or myocardial infarction within 30 days (myocardial infarction was defined as a post-interventional cardiac troponin T level increase >2-fold the upper limit of normal in addition to either chest pain or symptoms consistent with ischemia or electrocardiographic evidence of ischemia) between carotid endarterectomy and carotid stenting groups."|30 days after intervention|||participants|||Number
678883|NCT01591005|Secondary|Number of Participatns With New Ipsilateral Brain Infarctions Detected Using MRI in Endarterectomy and Stenting Groups|"The number of patients with the ipsilateral brain infarctions detected using MRI examination 24 hours after intervention between endarterectomy and stenting using periprocedural sonolysis.
Substudy: The number of patients with the ipsilateral brain infarctions detected using MRI examination 24 hours after intervention between carotid endarterectomy and carotid stenting groups."|24 hours after intervention|||participants|||Number
678884|NCT01591005|Secondary|Number of Participants With Clinical Manifested Brain Infarction|"The risk of stroke or transient ischemic attack (at 24 hours and 30 days) due to the activation of endogenous fibrinolytic system during carotid endarterectomy and carotid stenting using periprocedural sonolysis.
Substudy: The risk of stroke or transient ischemic attack (at 24 hours and 30 days) due to the activation of endogenous fibrinolytic system between carotid endarterectomy and carotid stenting groups."|24 hours and 30 days after intervention|||participants|||Number
678885|NCT01591005|Secondary|Cognitive Decline|"The changes in cognitive functions after carotid endarterectomy and carotid stenting measured by Mini-Mental State Examination using periprocedural sonolysis.
Substudy: The changes in cognitive functions after intervention measured by Mini-Mental State Examination between carotid endarterectomy and carotid stenting groups.
Range of scores possible for the Mini-Mental State Examination: 0 - 30 points. Higher values in this range are considered to be a better outcome."|24 hours after intervention|only patients with performed Mini Mental State examination||Scores on a scale||Inter-Quartile Range|Median
678886|NCT01591005|Secondary|Participants With a New Brain Infarctions Detected Using Magnetic Resonance in Endarterectomy and Stenting Groups|"The number of participants with a new brain infarctions >0.5 cm3 detected using magnetic resonance examination 24 hours after intervention between endarterectomy and stenting using periprocedural sonolysis.
Substudy: The number of participants with a new brain infarctions >0.5 cm3 detected using magnetic resonance examination 24 hours after intervention between carotid endarterectomy and carotid stenting groups."|24 hours after intervention|||participants|||Number
678887|NCT01591005|Primary|Participants With a New Brain Infarction Detected Using Magnetic Resonance|"The number of participants with a new brain infarctions in sonolysis group detected using magnetic resonance examination 24 hours after carotid endarterectomy or carotid stenting.
Substudy: The number of participants with a new brain infarctions on brain diffusion-weighted magnetic resonance imaging performed 24 hours after intervention in carotid endarterectomy and carotid stenting groups."|24 hours after intervention|||participants|||Number
678888|NCT01590979|Primary|Incidence of New Onset Atrial Fibrillation Rate in Post-Operative Cardiac Surgery Patients||3 weeks after surgery|Fifty-four patients were randomized with a mean follow-up of 25 months and none were lost to follow-up. The study was terminated due to slow rate of accrual resulting in a sample size of 27 ranolazine and 27 placebo.||Participants|||Count of Participants
678889|NCT01590888|Secondary|Change From Baseline in Cognitive Test Battery - TMT Part B|"Trail Making Test Part B was assessed by the number of seconds to complete the test (from 0 to 240 seconds).
The Trails Making Test Part B actual change from baseline at Week 26 was analysed."|Baseline to 26 weeks|Intent to Treat||seconds||Standard Deviation|Mean
678890|NCT01590888|Secondary|Change From Baseline in Brain Function (MRI)|Measure of the structural brain volume as assessed by the left caudate volume.|Baseline to 26 weeks|ITT population. MRI was performed at one site only, resulting in a subset of participants available for analysis.||mm^3||Standard Deviation|Mean
678891|NCT01590888|Secondary|Change From Baseline in Urine Biomarkers|Biomarkers assessed primarily with 8-hydroxy-2'-deoxyguanosine, normalised to creatinine concentrations, as a change from baseline.|Baseline to 26 weeks|ITT population||ng/mL||Standard Deviation|Mean
678892|NCT01590888|Secondary|Change From Baseline in Blood Biomarkers - Selenium|Biomarkers assessed primarily with plasma selenium as a change from baseline.|Baseline to 26 weeks|ITT population||ug/L||Standard Deviation|Mean
678893|NCT01590888|Secondary|Change From Baseline in Blood Biomarkers|Biomarkers assessed primarily with soluble huntingtin protein, normalised to lysate protein concentrations, as a change from baseline.|Baseline to 26 weeks|ITT population||mg/mL||Standard Deviation|Mean
678894|NCT01590888|Secondary|Change From Baseline in Brain Function (MRI)|Measure of whole brain iron concentrations.|Baseline to 26 weeks|ITT population. MRI was performed at one site only, resulting in a subset of participants available for analysis.||mm^3||Standard Deviation|Mean
678895|NCT01590888|Secondary|Change From Baseline in Blood Biomarkers|Biomarkers assessed primarily with mutant huntingtin protein, normalised to lysate protein concentrations, as a change from baseline.|Baseline to 26 weeks|ITT population||ratio||Standard Deviation|Mean
678896|NCT01590888|Secondary|Change From Baseline in Investigator Global Assessments by Efficacy Index|Global function was assessed by the Investigator using the clinical global impression (CGI) scale which included assessing the severity of illness and global improvement and calculating the efficacy index for each participant. The efficacy index aims to relate therapeutic effects to reported side effects as assessed by the Investigator (range from 0 [marked improvement and no side effects] to 4 [unchanged or worse] and side effects outweigh therapeutic effects) and is calculated for each participant by dividing the therapeutic effect score by the side effects score. An improvement is reflected by CGI scale Efficacy Index values >1.|Baseline to 26 weeks|Intent to Treat||ratio||Standard Deviation|Mean
678974|NCT01589978|Secondary|Target Vessel Revascularization (TVR) Rate|Target vessel revascularization is defined as any attempted or successfully completed percutaneous or surgical revascularization of a target vessel.|≤24 hours, 30 days, 180 days, annually through 5 years|||percentage of patients|||Number
678897|NCT01590888|Secondary|Change From Baseline in Behaviour|Total Behavioural score from the Unified Huntington Disease Rating Scale. The behavioural assessment measures the frequency and severity of symptoms related to affect, thought content and coping styles. The total behaviour score is the sum of all responses, with scale range of 0 to 8. Higher scores on the behaviour assessments indicate more severe disturbance than lower scores.|Baseline to 26 weeks|Intent to Treat population analysed||units on a scale||Standard Deviation|Mean
678898|NCT01590888|Secondary|Change From Baseline in Functional Abilities|"Total Functional Capacity (TFC) assessment was based on an individual's ability to perform common daily tasks. TFC score range was 0 to 13.
Higher scores on the function scales indicate better functioning than lower scores."|Baseline to 26 weeks|Intent to Treat Population analysed||units on a scale||Standard Deviation|Mean
678899|NCT01590888|Secondary|Change From Baseline in Motor Function|Total motor score calculated from the Unified Huntington Disease Rating Scale - Motor Function. The motor section of the UHDRS assesses motor features of HD with standardized ratings of oculomotor function, dysarthria, chorea, dystonia, gait, and postural stability. The total motor impairment scores is the sum of all the individual motor ratings, with higher scores indicating more severe motor impairment than lower scores. A maximum score of 60 is possible (range 0-60).|Baseline to 26 weeks|Intent to Treat population analysed, and defined as all participants who received at least one dose of study and underwent at least one post baseline efficacy assessment.||units on a scale||Standard Deviation|Mean
678900|NCT01590888|Secondary|Change From Baseline in Cognitive Test Battery - Composite z Scores|Cognition composite z-scores were calculated for each participant. The composite scores were defined as the mean of the individual z-scores for the various cognition assessments. The Main Composite z-score was calculated for Category Fluency Test, Trail Making Test Part B, Map Search, Symbol Digit Modalities Test and Stroop Word Reading Test. The Exploratory Composite z-score was calculated for Category Fluency Test, Trail Making Test Part B, Map Search, Symbol Digit Modalities Test, Stroop Word Reading Test and Speeded Tapping test. The Executive Function Composite z-score was calculated from Category Fluency Test and Trail Making Test Part B. There is no unit of measure for the z score as it is the pure number calculated from the SD from the mean. A higher z score indicates an improvement.|Baseline to 26 weeks|Intent to Treat||z score||Standard Deviation|Mean
678901|NCT01590888|Primary|Safety and Tolerability of PBT2 in Patients With HD|As measured by the total number of participants in each dose group who reported at least one adverse events during the study,|Baseline to 26 weeks|Safety population as defined as all participants who received at least one dose of study drug.||participants|||Number
678902|NCT01590875|Secondary|Adverse Effects Atrial Fibrillation Ablation|At 1 month, 3 month, 6 month and 12 months post ablation routine clinic visits, will perform chart review to evaluate for adverse effects of procedure and or adenosine administration.|Assess at follow-up visits 1,3 6,12 months post ablation|Due to lack of funding only acute adenosine study was completed. Analysis over one year to look at adverse effects atrial fibrillation ablation was not completed, completion of study limited by lack of funding.|||||
678903|NCT01590875|Secondary|AF Recurrence|At 1 month, 3 month, 6 month and 12 months post ablation routine clinic visits, will perform chart review to evaluate for adverse effects of procedure and or adenosine administration and AF recurrence.|Assess at follow-up visits 1,3,6, 12 months post ablation|Due to lack of funding study was terminated and we were unable to follow up clinical outcome of AF recurrence after the acute drug study.|||||
678904|NCT01590875|Primary|Pulmonary Vein Reconnection|In treatment group, 30 minutes after all veins confirmed to be isolated with lasso catheter, 12 mg IV adenosine will be given to treatment group subjects, will monitor with lasso catheter for pulmonary vein reconnection for 5 minutes, if no reconnection, a second dose adenosine will be given and will monitor for additional 5 minutes for pulmonary vein reconnection. Criteria for pulmonary vein reconnection will be recurrence of local pulmonary vein electrical recordings noted on lasso catheter located within the vein.|Pulmonary vein reconnection will be measured 5 minutes post second dose of adenosine, or on average 15 minutes after initial electrical isolation of the pulmonary vein.|||Participants|||Count of Participants
678905|NCT01590875|Primary|Pulmonary Vein Reconnection|In treatment group, 30 minutes after all veins confirmed to be isolated with lasso catheter, 12 mg IV adenosine will be given to treatment group subjects, will monitor with lasso catheter for pulmonary vein reconnection for 5 minutes.|5 minutes post infusion first dose adenosine|||Participants|||Count of Participants
678906|NCT01590810|Primary|Change From Baseline in TWA0-24hrs pDBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel D)|pDBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pDBP value by that pDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|Per-Protocol population. The same 2 participants received placebo throughout all treatment periods of Panel D. Data for all administrations of placebo in these participants are included (i.e., for placebo, analysis includes 8 observations from 2 participants)||mm Hg||Standard Error|Least Squares Mean
678907|NCT01590810|Primary|Change From Baseline in TWA0-24hrs pDBP in Male Participants With Mild to Moderate Hypertension Administered Single Doses of MK-8150 and Placebo (Panel C)|pDBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pDBP value by that pDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|Per-Protocol population||mm Hg||Standard Error|Least Squares Mean
678969|NCT01589978|Secondary|Rate of Target Vessel Failure (TVF) Related to the PROMUS Element Stent|"Target vessel failure (TVF) is defined as any revascularization of the target vessel, myocardial infarction (MI) related to the target vessel, or death related to the target vessel.
For the purposes of this protocol, if it cannot be determined with certainty whether MI or death was related to the target vessel it will be considered TVF."|≤24 hours, 30 days, 180 days, annually through 5 years|||percentage of patients|||Number
678908|NCT01590810|Primary|Change From Baseline in TWA0-24hrs pDBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel B)|pDBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pDBP value by that pDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|Per-Protocol population. 2 participants received placebo in period of initial administration of MK-8150 120 mg dose and again received placebo during the period of repeat administration of that dose. Data for both administrations of placebo in these participants are included (i.e., for placebo, analysis includes 10 observations from 8 participants)||mm Hg||Standard Error|Least Squares Mean
678909|NCT01590810|Primary|Change From Baseline in TWA0-24hrs pDBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel A)|pDBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pDBP value by that pDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|Per-Protocol population. 2 participants received placebo in period of fasted administration of MK-8150 24 mg dose and again received placebo during the period of fed administration of that dose. Data for both administrations of placebo in these participants are included (i.e., for placebo, analysis includes 10 observations from 8 participants)||mm Hg||Standard Error|Least Squares Mean
678910|NCT01590810|Primary|Change From Baseline in TWA0-24hrs pSBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel D)|pSBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pSBP value by that pSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|Per-Protocol population. The same 2 participants received placebo throughout all treatment periods of Panel D. Data for all administrations of placebo in these participants are included (i.e., for placebo, analysis includes 8 observations from 2 participants)||mm Hg||Standard Error|Least Squares Mean
678911|NCT01590810|Primary|Change From Baseline in TWA0-24hrs pSBP in Male Participants With Mild to Moderate Hypertension Administered Single Doses of MK-8150 and Placebo (Panel C)|pSBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pSBP value by that pSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|Per-Protocol population||mm Hg||Standard Error|Least Squares Mean
678912|NCT01590810|Primary|Change From Baseline in TWA0-24hrs pSBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel B)|pSBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pSBP value by that pSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|Per-Protocol population. 2 participants received placebo in period of initial administration of MK-8150 120 mg dose and again received placebo during the period of repeat administration of that dose. Data for both administrations of placebo in these participants are included (i.e., for placebo, analysis includes 10 observations from 8 participants)||mm Hg||Standard Error|Least Squares Mean
678913|NCT01590810|Primary|Change From Baseline in TWA0-24hrs pSBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel A)|pSBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pSBP value by that pSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|Per-Protocol population. 2 participants received placebo in period of fasted administration of MK-8150 24 mg dose and again received placebo during the period of fed administration of that dose. Data for both administrations of placebo in these participants are included (i.e., for placebo, analysis includes 10 observations from 8 participants)||mm Hg||Standard Error|Least Squares Mean
678932|NCT01590797|Primary|Number of Participants Discontinuing Study Medication Due to an AE|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to Week 24|The APaT population consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.||Participants|||Number
679004|NCT01589510|Secondary|Percentage of Patients Who Discontinue Lumigan® 0.01% Prior to 14 Weeks of Treatment|Patients who discontinued Lumigan® 0.01% prior to 14 weeks was assessed as Yes or No.|14 Weeks|All patients||Percentage of Patients|||Number
678914|NCT01590810|Primary|Change From Baseline in TWA0-24hrs cDBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel D)|cDBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cDBP value by that cDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose|Per-Protocol population. The same 2 participants received placebo throughout all treatment periods of Panel D. Data for all administrations of placebo in these participants are included (i.e., for placebo, analysis includes 8 observations from 2 participants)||mm Hg||Standard Error|Least Squares Mean
678915|NCT01590810|Primary|Change From Baseline in TWA0-24hrs cDBP in Male Participants With Mild to Moderate Hypertension Administered Single Doses of MK-8150 and Placebo (Panel C)|cDBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cDBP value by that cDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose|Per-Protocol population||mm Hg||Standard Error|Least Squares Mean
678916|NCT01590810|Primary|Change From Baseline in TWA0-24hrs cDBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel B)|cDBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cDBP value by that cDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose|Per-Protocol population. 2 participants received placebo in period of initial administration of MK-8150 120 mg dose and again received placebo during the period of repeat administration of that dose. Data for both administrations of placebo in these participants are included (i.e., for placebo, analysis includes 10 observations from 8 participants)||mm Hg||Standard Error|Least Squares Mean
678917|NCT01590810|Primary|Change From Baseline in TWA0-24hrs cDBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel A)|cDBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cDBP value by that cDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose|Per-Protocol population. 2 participants received placebo in period of fasted administration of MK-8150 24 mg dose and again received placebo during the period of fed administration of that dose. Data for both administrations of placebo in these participants are included (i.e., for placebo, analysis includes 10 observations from 8 participants)||mm Hg||Standard Error|Least Squares Mean
678918|NCT01590810|Primary|Change From Baseline in TWA0-12hrs HR in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel D)|HR was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all HR values obtained over the 12-hour observation period, multiply the length of time that the participant spent at each HR value by that HR value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified HR value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post dose|Per-Protocol population. The same 2 participants received placebo throughout all treatment periods of Panel D. Data for all administrations of placebo in these participants are included (i.e., for placebo, analysis includes 8 observations from 2 participants)||beats per minute||Standard Error|Least Squares Mean
678919|NCT01590810|Primary|Change From Baseline in TWA0-12hrs HR in Male Participants With Mild to Moderate Hypertension Administered Single Doses of MK-8150 and Placebo (Panel C)|HR was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all HR values obtained over the 12-hour observation period, multiply the length of time that the participant spent at each HR value by that HR value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified HR value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post dose|Per-Protocol population||beats per minute||Standard Error|Least Squares Mean
678933|NCT01590797|Primary|Number of Participants With One or More Adverse Events|An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to Week 26|The All Patients as Treated (APaT) population consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.||Participants|||Number
679147|NCT01587079|Secondary|Change From Baseline in Mean Morning Post-dose Daily Peak Flow Readings on Day 7|Change from baseline in mean morning post-dose daily peak flow readings on|Day 7|MITT||L/min||95% Confidence Interval|Least Squares Mean
678920|NCT01590810|Primary|Change From Baseline in TWA0-12hrs HR in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel B)|HR was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all HR values obtained over the 12-hour observation period, multiply the length of time that the participant spent at each HR value by that HR value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified HR value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post dose|Per-Protocol population. 2 participants received placebo in period of initial administration of MK-8150 120 mg dose and again received placebo during the period of repeat administration of that dose. Data for both administrations of placebo in these participants are included (i.e., for placebo, analysis includes 10 observations from 8 participants)||beats per minute||Standard Error|Least Squares Mean
678921|NCT01590810|Primary|Change From Baseline in Time-weighted Average Across 12 Hours (TWA0-12hrs) HR in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel A)|HR was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all HR values obtained over the 12-hour observation period, multiply the length of time that the participant spent at each HR value by that HR value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified HR value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post dose|Per-Protocol population. 2 participants received placebo in period of fasted administration of MK-8150 24 mg dose and again received placebo during the period of fed administration of that dose. Data for both administrations of placebo in these participants are included (i.e., for placebo, analysis includes 10 observations from 8 participants)||beats per minute||Standard Error|Least Squares Mean
678922|NCT01590810|Primary|Change From Baseline in TWA0-24hrs AIx in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel D)|AIx was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Augmentation index is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. Time-weighted average was obtained as follows: For all AIx values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each AIx value by that AIx value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified AIx value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. AIx was adjusted for HR.|Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose|Per-Protocol population. The same 2 participants received placebo throughout all treatment periods of Panel D. Data for all administrations of placebo in these participants are included (i.e., for placebo, analysis includes 8 observations from 2 participants)||percentage of central pulse pressure||Standard Error|Least Squares Mean
678923|NCT01590810|Primary|Change From Baseline in TWA0-24hrs AIx in Male Participants With Mild to Moderate Hypertension Administered Single Doses of MK-8150 and Placebo (Panel C)|AIx was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Augmentation index is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. Time-weighted average was obtained as follows: For all AIx values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each AIx value by that AIx value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified AIx value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. AIx was adjusted for HR.|Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose|Per-Protocol population||percentage of central pulse pressure||Standard Error|Least Squares Mean
678924|NCT01590810|Primary|Change From Baseline in TWA0-24hrs AIx in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel B)|AIx was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Augmentation index is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. Time-weighted average was obtained as follows: For all AIx values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each AIx value by that AIx value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified AIx value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. AIx was adjusted for HR.|Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose|Per-Protocol population. 2 participants received placebo in period of initial administration of MK-8150 120 mg dose and again received placebo during the period of repeat administration of that dose. Data for both administrations of placebo in these participants are included (i.e., for placebo, analysis includes 10 observations from 8 participants)||percentage of central pulse pressure||Standard Error|Least Squares Mean
678934|NCT01590797|Secondary|Change From Baseline in 2-Hour Post Meal Glucose Levels at Week 24 in Participants Receiving Insulin Alone or in Combination With Metformin||Baseline and Week 24|The FAS consisted of all randomized participants receiving insulin alone or in combination with metformin, took at least one dose of study treatment, had at least one observation for the analysis endpoint subsequent to the first dose of study treatment, and had baseline data for the analysis endpoint.||mg/dL||95% Confidence Interval|Least Squares Mean
678935|NCT01590797|Secondary|Change From Baseline in HbA1C Levels at Week 24 in Participants Receiving Insulin in Combination With Metformin||Baseline and Week 24|The FAS consisted of all randomized participants receiving insulin in combination with metformin, took at least one dose of study treatment, had at least one observation for the analysis endpoint subsequent to the first dose of study treatment, and had baseline data for the analysis endpoint.||A1C %||95% Confidence Interval|Least Squares Mean
678925|NCT01590810|Primary|Change From Baseline in TWA0-24hrs AIx in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel A)|AIx was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Augmentation index is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. Time-weighted average was obtained as follows: For all AIx values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each AIx value by that AIx value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified AIx value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. AIx was adjusted for HR.|Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose; except Period 1: Pre-dose and 2, 4, 12 and 24 hours post dose|Per-Protocol population. 2 participants received placebo in period of fasted administration of MK-8150 24 mg dose and again received placebo during the period of fed administration of that dose. Data for both administrations of placebo in these participants are included (i.e., for placebo, analysis includes 10 observations from 8 participants)||percentage of central pulse pressure||Standard Error|Least Squares Mean
678926|NCT01590810|Primary|Change From Baseline in TWA0-24hrs cSBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel D)|cSBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cSBP value by that cSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose|Per-Protocol population. The same 2 participants received placebo throughout all treatment periods of Panel D. Data for all administrations of placebo in these participants are included (i.e., for placebo, analysis includes 8 observations from 2 participants)||mm Hg||Standard Error|Least Squares Mean
678927|NCT01590810|Primary|Change From Baseline in TWA0-24hrs cSBP in Male Participants With Mild to Moderate Hypertension Administered Single Doses of MK-8150 and Placebo (Panel C)|cSBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cSBP value by that cSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose|Per-Protocol population||mm Hg||Standard Error|Least Squares Mean
678928|NCT01590810|Primary|Change From Baseline in TWA0-24hrs cSBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel B)|cSBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cSBP value by that cSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose|Per-Protocol population. 2 participants received placebo in period of initial administration of MK-8150 120 mg dose and again received placebo during the period of repeat administration of that dose. Data for both administrations of placebo in these participants are included (i.e., for placebo, analysis includes 10 observations from 8 participants)||mm Hg||Standard Error|Least Squares Mean
678929|NCT01590810|Primary|Change From Baseline in Time-weighted Average Across 24 Hours (TWA0-24hrs) cSBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel A)|cSBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cSBP value by that cSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose|Per-Protocol population. 2 participants received placebo in period of fasted administration of MK-8150 24 mg dose and again received placebo during the period of fed administration of that dose. Data for both administrations of placebo in these participants are included (i.e., for placebo, analysis includes 10 observations from 8 participants)||mm Hg||Standard Error|Least Squares Mean
678930|NCT01590810|Primary|Number of Participants Who Discontinued Study Due to an AE|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE.|Up to 14 days after the last dose (Up to approximately 42 days)|All participants who received a dose of study drug||participants|||Number
678931|NCT01590810|Primary|Number of Participants With an Adverse Event (AE)|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE.|Up to 14 days after the last dose (Up to approximately 42 days)|All participants who received a dose of study drug||participants|||Number
678936|NCT01590797|Primary|Change From Baseline in Hemoglobin A1C (HbA1C) Levels at Week 24 in Participants Receiving Insulin Alone or in Combination With Metformin||Baseline and Week 24|The Full Analysis Set (FAS) consisted of all randomized participants receiving insulin alone or in combination with metformin, took at least one dose of study treatment, had at least one observation for the analysis endpoint subsequent to the first dose of study treatment, and had baseline data for the analysis endpoint.||A1C %||95% Confidence Interval|Least Squares Mean
678937|NCT01590771|Primary|Number of Participants Who Discontinued Study Drug Due to an Adverse Event|An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of pre-existing conditions.|Up to 24 weeks|All participants as treated population defined as all randomized participants who received at least one dose of study medication. Participants are included in the treatment group corresponding to the study treatment actually received.||Participants|||Number
678938|NCT01590771|Primary|Number of Participants Who Experienced an Adverse Event|An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of pre-existing conditions.|Up to 26 weeks|All participants as treated population defined as all randomized participants who received at least one dose of study medication. Participants are included in the treatment group corresponding to the study treatment actually received.||Participants|||Number
678939|NCT01590771|Secondary|Change From Baseline in FPG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone|This change from baseline reflects the FPG level at Week 24 minus the FPG level at Week 0.|Baseline and Week 24|Full analysis set (not on metformin) consists of all participants not on metformin who received at least one dose of study drug, have a baseline measurement, and have at least one post-randomization measurement.||mg/dL||95% Confidence Interval|Least Squares Mean
678940|NCT01590771|Secondary|Change From Baseline in FPG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea in Combination With Metformin|This change from baseline reflects the FPG level at Week 24 minus the FPG level at Week 0.|Baseline and Week 24|Full analysis set (on metformin) consists of all participants on metformin who received at least one dose of study drug, have a baseline measurement, and have at least one post-randomization measurement.||mg/dL||95% Confidence Interval|Least Squares Mean
678941|NCT01590771|Secondary|Change From Baseline in 2-hr PMG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone|This change from baseline reflects the 2-hr PMG level at Week 24 minus the 2-hr PMG level at Week 0.|Baseline and Week 24|Full analysis set (not on metformin) consists of all participants not on metformin who received at least one dose of study drug, have a baseline measurement, and have at least one post-randomization measurement.||mg/dL||95% Confidence Interval|Least Squares Mean
678942|NCT01590771|Secondary|Change From Baseline in 2-hr PMG Levels at Week 24 in Participants Receiving Sitagliptin and a Sulfonylurea in Combination With Metformin|This change from baseline reflects the 2-hr PMG level at Week 24 minus the 2-hr PMG level at Week 0.|Baseline and Week 24|Full analysis set (on metformin) consists of all participants on metformin who received at least one dose of study drug, have a baseline measurement, and have at least one post-randomization measurement.||mg/dL||95% Confidence Interval|Least Squares Mean
678943|NCT01590771|Secondary|Change From Baseline in A1C Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone|A1C was measured as a percent. This change from baseline reflects the A1C percent at Week 24 minus the A1C percent at Week 0.|Baseline and Week 24|Full analysis set (not on metformin) consists of all participants not on metformin who received at least one dose of study drug, have a baseline measurement, and have at least one post-randomization measurement.||Percent of glycosylated hemoglobin (A1C)||95% Confidence Interval|Least Squares Mean
678944|NCT01590771|Secondary|Change From Baseline in A1C Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea in Combination With Metformin|A1C was measured as a percent. This change from baseline reflects the A1C percent at Week 24 minus the A1C percent at Week 0.|Baseline and Week 24|Full analysis set (on metformin) consists of all participants on metformin who received at least one dose of study drug, have a baseline measurement, and have at least one post-randomization measurement.||Percent of glycosylated hemoglobin (A1C)||95% Confidence Interval|Least Squares Mean
678945|NCT01590771|Secondary|Change From Baseline in FPG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone or in Combination With Metformin|This change from baseline reflects the FPG level at Week 24 minus the FPG level at Week 0.|Baseline and Week 24|Full analysis set consists of all participants who received at least one dose of study drug, have a baseline measurement, and have at least one post-randomization measurement.||mg/dL||95% Confidence Interval|Least Squares Mean
678946|NCT01590771|Secondary|Change From Baseline in 2-hr PMG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone or in Combination With Metformin|This change from baseline reflects the 2-hr PMG level at Week 24 minus the 2-hr PMG level at Week 0.|Baseline and Week 24|Full analysis set consists of all participants who received at least one dose of study drug, have a baseline measurement, and have at least one post-randomization measurement.||mg/dL||95% Confidence Interval|Least Squares Mean
678947|NCT01590771|Primary|Change From Baseline in A1C Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone or in Combination With Metformin|A1C was measured as a percent. This change from baseline reflects the A1C percent at Week 24 minus the A1C percent at Week 0.|Baseline and Week 24|Full analysis set consists of all participants who received at least one dose of study drug, have a baseline measurement, and have at least one post-randomization measurement.||Percent of glycosylated hemoglobin (A1C)||95% Confidence Interval|Least Squares Mean
678948|NCT01590758|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAE)|The numbers of participants with TEAEs, including those with Serious TEAEs, are reported|28 days|Safety||Participants|||Count of Participants
678949|NCT01590758|Secondary|Number of Participants With Microbiological Success|The numbers of participants with Microbiological Response, defined as eradication of all initial pathogens, are reported.|28 days|Intent-To-Treat Microbiological (positive for baseline pathogens)||Participants|||Count of Participants
678950|NCT01590758|Primary|Number of Participants With Clinical Response|The numbers of participants with Clinical Response, defined as resolution of infection, are reported.|28 days|Intent-To-Treat||Participants|||Count of Participants
678954|NCT01590550|Secondary|Heparin Use Rate|The heparin use rate will be assessed as the percentage of hemodialysis treatments that required additional use of heparin to maintain circuit patency. This will be assessed from the time that the patient is enrolled in the study until the time hemodialysis treatments with Citrasate® are discontinued based on clinical indications, upto a maximum period of 6 months|Patients will be followed until inpatient hemodialysis sessions with Citrasate® are discontinued|||percentage of hemodialysis treatments|||Number
678955|NCT01590550|Secondary|Saline Flush Rate|Saline flush rate will be assesed as the percentage of hemodialysis treatments that require one or more saline flushes to maintain circuit patency from the time that the patient is enrolled in the study until the time hemodialysis treatments with Citrasate® are discontinued based on clinical indications, upto a maximum period of 6 months|Patients will be followed until HD Citrate dialysate is discontinued, average 3 weeks|||percentage of hemodialysis treatments|||Number
678956|NCT01590550|Primary|Dialyzer Clotting Rate|Dialyzer clotting rate will be assessed as the percent of hemodialysis treatments that developed a clot in the dialyzer from the time that the patient is enrolled in the study until the time hemodialysis treatments with Citrasate® are discontinued.|Followed until HD with Citrate dialysate is discontinued, average 3 weeks|18 patients and 119 HD treatments||percentage of total treatments|||Number
678957|NCT01590264|Secondary|Change in Tinnitus Handicap Inventory|Participant will complete the Tinnitus Handicap Inventory (THI)at the end of 2 weeks of treatment. Difference of the THI post treatmement minus baseline THI was calculated. Scale ranges in scores from 0 to 100 with 0 = no bother and 100 being the most bothered.|Baseline, 2 weeks|Pilot study convenience sample||units on a scale||Full Range|Median
678958|NCT01590264|Primary|Adverse Events|Subject will be queried for Adverse Events daily for 2 weeks of treatment. This is foremost a feasibility study, so measure of Adverse Events and relation to treatment is primary outcome.|Daily for 2 weeks.|Pilot study based on convenience sample.||participants|||Number
678959|NCT01590238|Primary|Hair Density Change After Three Treatments|Hair density index at calibrated distance from glabella in a 2 cm x 2 cm midline square at 6 month follow up visit as a percentage of initial (pre-treatment) hair density index, measured using a proprietary hair densitometer.|6 months after initial visit|||percentage of pre-treatment hair density||Standard Deviation|Mean
678960|NCT01590212|Primary|Depression Measured on EPDS|"Depression scores as measured on the EPDS post-birth (approximately 8-12 weeks postnatal)
Edinburgh Postnatal Depression Scale (EPDS): is a standardised questionnaire which generates a single score. Normal score=0-9, Borderline=10-12, Probable depression=13-30."|Post-birth (8-12 weeks postnatal)|||scores on a scale||Full Range|Mean
678961|NCT01590212|Primary|Anxiety, Depression and Irritability Measured on Adult Wellbeing Scale|"Anxiety, depression and irritability measured on the Adult Wellbeing Scale post-birth (approximately 8-12 weeks postnatal)
The Adult Wellbeing scale (AWS): a validated questionnaire which generates scores in four domains - depression, anxiety, outward-directed irritability and inward-directed irritability. The sub-scales have different cut-off scores that indicate a possible problem in that area: Anxiety (normal=0-5, borderline=6-8, problem 9-15), Depression (normal=0-3, borderline=4-6, problem 7-15), Outward directed irritability (normal=0-4, borderline=5-7, problem 8-12), Inward directed irritability (normal=0-3, borderline=4-6, problem 7-12),"|Post-birth (8-12 weeks postnatal)|||scores on a scale||Full Range|Mean
678962|NCT01590212|Primary|Depression Measured on EPDS|"Depression as measured on the EPDS at 9-12 weeks after baseline
Edinburgh Postnatal Depression Scale (EPDS): is a standardised questionnaire which generates a single score. Normal score=0-9, Borderline=10-12, Probable depression=13-30."|Post-intervention (approximately 9 -12 weeks after baseline)|||scores on a scale||Full Range|Mean
678963|NCT01590212|Primary|Anxiety, Depression and Irritability Measured on Adult Wellbeing Scale|"Anxiety, depression and irritability measured on Adult Wellbeing Scale at 9-12 weeks after baseline.
The Adult Wellbeing scale (AWS): a validated questionnaire which generates scores in four domains - depression, anxiety, outward-directed irritability and inward-directed irritability. The sub-scales have different cut-off scores that indicate a possible problem in that area: Anxiety (normal=0-5, borderline=6-8, problem 9-15), Depression (normal=0-3, borderline=4-6, problem 7-15), Outward directed irritability (normal=0-4, borderline=5-7, problem 8-12), Inward directed irritability (normal=0-3, borderline=4-6, problem 7-12),"|Post intervention (approximately 9-12 weeks after baseline)|||Scores on a scale||Full Range|Mean
678964|NCT01589978|Secondary|ARC ST Rate in PLATINUM-like Population.|Using the Academic Research Consortium (ARC) definition, the (definite/probable) stent thrombosis (ST) rate in the PLATINUM-like* population will be analyzed. Statistical testing will be used to determine if the annual increase after the first year in ST rates observed in PLATINUM-like patients meets the performance goal of 1.0% (expected rate of 0.4% + a delta of 0.6%).|Annually through 5 years|Note: PLATINUM-like population for the Primary Endpoint at 12 months includes PROMUS Element patients from the PLATINUM trials (WH and SV) (N=862), PLATINUM-like patients from PE-Prove (N=269), and PLATINUM-like patients from PROMUS Element Plus US Post-Approval Study (N=776) (as stated as a subgroup in the Participant Flow Module.||percentage of participants|||Number
678965|NCT01589978|Secondary|Target Vessel Failure (TVF) Rate in PLATINUM-like Medically Treated Diabetic Patients|Any revascularization of the target vessel, myocardial infarction related to the target vessel, or death related to the target vessel. See individual components for descriptions. Statistical testing will determine if the rate meets the performance goal (12.6%)|12 Months|||percentage of patients|||Number
678966|NCT01589978|Secondary|All Death or Myocardial Infarction Rate|See description of individual events.|≤24 hours, 30 days, 180 days, annually through 5 years|||percentage of patients|||Number
678967|NCT01589978|Secondary|Non-cardiac Death Rate|"Non-cardiac death is defined as death not due to cardiac causes.
Cardiac death is death due to any of the following: acute myocardial infarction; cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident through hospital discharge or cerebrovascular accident suspected of being related to the procedure; death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery; any death in which a cardiac cause cannot be excluded."|≤24 hours, 30 days, 180 days, annually through 5 years|||percentage of patients|||Number
678968|NCT01589978|Secondary|All Death Rate|All death includes cardiac death and non-cardiac death.|≤24 hours, 30 days, 180 days, annually through 5 years|||percentage of patients|||Number
678975|NCT01589978|Secondary|Rate of Cardiac Death Events Related to the PROMUS Element Stent|Cardiac death is defined as death due to any of the following: acute myocardial infarction; cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident through hospital discharge or cerebrovascular accident suspected of being related to the procedure; death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery; any death in which a cardiac cause cannot be excluded|≤24 hours, 30 days, 180 days, annually through 5 years|||percentage of patients|||Number
678976|NCT01589978|Secondary|Cardiac Death Rate|Cardiac death is defined as death due to any of the following: acute myocardial infarction; cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident through hospital discharge or cerebrovascular accident suspected of being related to the procedure; death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery; any death in which a cardiac cause cannot be excluded|≤24 hours, 30 days, 180 days, annually through 5 years|||percentage of patients|||Number
678977|NCT01589978|Secondary|Rate of Myocardial Infarction (MI) Events Related to the PROMUS Element Stent|New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase myoglobin band(CK-MB) or troponin >upper limit of normal(ULN); if no new Q-waves total CK levels >3×ULN (peri-percutaneous coronary intervention [PCI]) or >2×ULN (spontaneous) with elevated CK-MB or troponin >3×ULN (peri-PCI) or >2×ULN (spontaneous) plus ≥one of the following: ECG changes indicating new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5×ULN|≤24 hours, 30 days, 180 days, annually through 5 years|||percentage of patients|||Number
678978|NCT01589978|Secondary|Myocardial Infarction (MI) Rate|New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase myoglobin band(CK-MB) or troponin >upper limit of normal(ULN); if no new Q-waves total CK levels >3×ULN (peri-percutaneous coronary intervention [PCI]) or >2×ULN (spontaneous) with elevated CK-MB or troponin >3×ULN (peri-PCI) or >2×ULN (spontaneous) plus ≥one of the following: ECG changes indicating new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5×ULN|≤24 hours, 30 days, 180 days, annually through 5 years|||percentage of patients|||Number
678979|NCT01589978|Secondary|Rate of Major Adverse Cardiac Events Related to the PROMUS Element Stent|Composite of cardiac death, myocardial infarction, and target vessel revascularization related to the PROMUS Element stent|≤24 hours, 30 days, 180 days, annually through 5 years|||percentage of patients|||Number
678980|NCT01589978|Secondary|Major Adverse Cardiac Event Rate (MACE)|Composite of cardiac death, myocardial infarction, and target vessel revascularization|≤24 hours, 30 days, 180 days, annually through 5 years|||percentage of patients|||Number
678981|NCT01589978|Secondary|Rate of Longitudinal Stent Deformation|Compression/elongation of a stent along its long axis resulting from interaction with an ancillary device (e.g., guide catheter) which catches the stent end or an internal stent strut; can occur with advancement or withdrawal of ancillary device. Under fluoroscopy, longitudinal compression usually results in increased strut density and elongation in decreased strut density ('pseudo-fracture'); both can occur in the same stent.|Index Procedure|||stents|||Number
678982|NCT01589978|Secondary|Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition in All Patients|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days)|≤24 hours, 30 days, 180 days, annually through 5 years|||percentage of patients|||Number
678983|NCT01589978|Secondary|Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition in PLATINUM-like Patients|ARC definite/probable ST rate in PLATINUM-like patients (no acute myocardial infarction, graft stenting, chronic total occlusion, in-stent restenosis, failed brachytherapy, bifurcation, ostial lesion, severe tortuosity, moderate/severe calcification, 3-vessel stenting, cardiogenic shock, left main disease, or acute/chronic renal dysfunction; lesion length ≤28 mm with reference vessel diameter ≥2.25 mm and <2.5 mm, or lesion length ≤24 mm with diameter ≥2.5 mm and ≤4.25 mm); statistical testing will assess if the annual ST rate increase after the first year meets the performance goal (1.0%)|12 months|PROMUS Element PLATINUM-Like patients (a subgroup of the overall population as described in the Participant Flow Module), N=776.||percentage of patients|||Number
678984|NCT01589978|Primary|Cardiac Death or Myocardial Infarction Rate in PLATINUM-like Patients|Cardiac death or myocardial infarction rate at 12 months post implantation in PLATINUM-like patients (no acute myocardial infarction, graft stenting, chronic total occlusion, in-stent restenosis, failed brachytherapy, bifurcation, ostial lesion, severe tortuosity, moderate/severe calcification, 3-vessel stenting, cardiogenic shock, left main disease, or acute/chronic renal dysfunction; lesion length ≤28 mm with reference vessel diameter ≥2.25 mm and <2.5 mm, or lesion length ≤24 mm with diameter ≥2.5 mm and ≤4.25 mm); statistical testing will assess if rate meets the performance goal (3.2%)|12 months|Note: PLATINUM-like population for the Primary Endpoint at 12 months includes PROMUS Element patients from the PLATINUM trials (WH and SV) (N=862), PLATINUM-like patients from PE-Prove (N=269), and PLATINUM-like patients from PROMUS Element Plus US Post-Approval Study (N=776) (as stated as a subgroup in the Participant Flow Module.||percentage of patients|||Number
678985|NCT01589822|Secondary|Incidence of Stricture||up to Day 90|||participants|||Number
678986|NCT01589822|Secondary|Incidence of GI Leak||90 days|The primary endpoint was absence of leak (success) within 40 days. Any data missing was considered failures. 3 EVICEL and 2 SoC subjects had missing data. These subjects were considered failures for the primary endpoint. The secondary endpoint was incidence of leak within 90 days post operatively. Missing data was not assumed to be leaks.||participants|||Number
678987|NCT01589822|Secondary|Incidence of Adverse Events||up to Day 90|||number of adverse events|||Number
678988|NCT01589822|Primary|Absence of Gastrointestinal (GI) Leak||40 days|||participants|||Number
678989|NCT01589653|Secondary|Change in Patient Reported Outcomes: Treatment-Related Impact Measures for Diabetes (TRIM-D)-Treatment Burden|Mean change from baseline in Treatment Related Impact Measure - Diabetes (TRIM-D) scores. The score measured treatment satisfaction which included a subscale score -treatment burden. The scores were transformed to a 0−100 scale with higher scores indicating a better health state.|Week 0, week 20|Full analysis set (FAS) included all randomised subjects.||scores on a scale||Standard Deviation|Mean
678990|NCT01589653|Secondary|Change in Patient Reported Outcomes: Treatment-Related Impact Measures for Diabetes (TRIM-D)|Mean change from baseline in Treatment Related Impact Measure - Diabetes (TRIM-D) scores. The score measured treatment satisfaction which included an overall score as well the subscale scores (daily life, diabetes management, compliance and psychological health). The scores were transformed to a 0−100 scale with higher scores indicating a better health state.|Week 0, week 20|Full analysis set (FAS) included all randomised subjects.||scores on a scale||Standard Deviation|Mean
678991|NCT01589653|Secondary|Number of Hypoglycaemic Episodes During the Trial From Baseline|The number of hypoglycaemic episodes (a blood glucose level of approximately 2.8 mmol/L [50 mg/dL] or plasma glucose level 3.1 mmol/L [56 mg/dL]) during the trial.|Week 20|Full analysis set (FAS) included all randomised subjects. Missing data were imputed using last observation carried forward (LOCF). 154 subjects contributed to the analysis.||episodes|||Number
678992|NCT01589653|Secondary|Change in Fasting Plasma Glucose (FPG) (Laboratory Values) From Baseline|Change in FPG (laboratory values) from baseline to the end of the treatment period|Week 0, week 20|Full analysis set (FAS) included all randomised subjects. Missing data were imputed using last observation carried forward (LOCF). A total of 150 subjects contributed to the analysis.||mg/dL||Standard Deviation|Mean
678993|NCT01589653|Primary|Change in HbA1c From Baseline|Change in HbA1c (%) from baseline to the end of the treatment period.|Week 0, week 20|Full analysis set (FAS) included all randomised subjects.||percentage change in HbA1c||Standard Error|Least Squares Mean
678994|NCT01589601|Secondary|Utilization and Cost Measured by Hospital Readmissions|We evaluated the total burden of all-cause, cardiovascular and Heart Failure-specific readmissions with the palliative care intervention compared to usual care.|Baseline (2 weeks post hospital discharge), 6 months|||Number of readmissions|||Number
678995|NCT01589601|Secondary|Utilization and Cost Measured by the Aggregate Cost of Care|"We will use administrative data from Duke Health System to estimate costs of care to determine the cost effectiveness of palliative care versus normal care. At all follow-up points in the study (2 weeks, 6 weeks, 3 months, 6 months, and every 6 months thereafter), patients will be asked if they received care outside of the Duke Health System and to estimate the number of physician visits and/or days in the hospital. The cost of such care will be estimated using the Medical Expenditure Panel Survey and included in the aggregate cost of care from randomization until completion of the study.
Due to administrative delays, constraints and time to access the cost data, the study team is still working through the data aggregation for full utilization comparison as well as cost comparison."|time of randomization until end of follow-up, approximately 3.5 years||07/2017||||
678996|NCT01589601|Secondary|Change in FACIT-Sp|Spiritual well-being will be assessed using the Functional Assessment of Chronic Illness Therapy Spiritual Well-Being Scale (FACIT-Sp) at 2 weeks, 3 months, and 6 months. The FACIT-Sp is a 12 item scale which assesses the role of faith in illness and meaning, peace, and purpose in life. The range of FACIT-Sp 12 score is 0-48, with higher values representing an increased spirituality across the range of religious traditions.|Baseline (2 weeks post hospital discharge), 3 months, 6 months|Participants that completed the baseline, 3 month, and 6 month FACIT-Sp.||units on a scale||Standard Deviation|Mean
678997|NCT01589601|Secondary|After-Death Bereaved Family Member Interview - Hospice Version|A structured interview with the caregiver of those subjects that die during the study will be conducted 6 weeks following the study subject's death using the After-Death Bereaved Family Member Interview - Hospice Version. The interview provides an assessment of patient-focused, family-centered care and assesses overall quality of care received. An overall rating is derived from the ratings questions. The scoring is calculated using a pre-formatted Microsoft Excel spreadsheet for data entry and analysis. For scoring, the 5 rating questions were summed and the final scale varied between 0 (indicating worst possible care) to 50 (best possible care).|6 weeks after patient's death|Overall rating scale 6 weeks after patient's death.||units on a scale||Standard Deviation|Mean
678998|NCT01589601|Secondary|Change in Hospital Anxiety and Depression Scale (HADS) - Depression and Anxiety|"Depression and anxiety will be assessed in all patients using the self-administered Hospital Anxiety and Depression Scale (HADS) at 2 weeks, 3 months, and 6 months.
Range of HADS total score is 0-42. It is divided into depression and anxiety. Each is 0-21. A score of 11 or higher indicates the possible presence of the mood disorder (clinical caseness) with a score of 8 to 10 being suggestive of the presence of the respective state. The two subscales, anxiety and depression, have been found to be independent measures. In its current form the HADS in this study is divided into 3 ranges: normal (0-7), borderline (8-10), abnormal (11-21). Movement between categories would constitute a clinically significant change in the health status."|Baseline (2 weeks post hospital discharge), 3 months, 6 months|Participants that completed the baseline, 3 month, and 6 month HADS.||units on a scale||Standard Deviation|Mean
678999|NCT01589601|Primary|Change in Functional Assessment of Chronic Illness Therapy - Palliative Care Scale (FACIT-Pal)|"The primary endpoint is health-related quality of life as measured by the FACIT-Pal.
The FACIT-Pal is a 46-item measure of self-reported quality of life (27 general quality of life; 19 palliative care) that assesses quality of life in several domains. The range of FACIT-Pal total score is 0-184, a higher score is better."|Baseline, 6 months|Participants who completed the baseline and 6 month FACIT-Pal.||units on a scale||Standard Deviation|Mean
679000|NCT01589601|Primary|Change in Kansas City Cardiomyopathy Questionnaire (KCCQ)|"The primary endpoint is health-related quality of life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ).
The KCCQ is a 23-item, disease-specific questionnaire scored from 0-100 with high scores representing better health status."|Baseline, 6 months|Participants that completed the baseline and 6 month KCCQ||units on a scale||Standard Deviation|Mean
679001|NCT01589510|Primary|IOP at Week 14|IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Week 14.|Week 14|All patients with data for this outcome measure||Millimeters of Mercury||Standard Deviation|Mean
679081|NCT01588158|Secondary|Pain Scale|11-point ordinal pain scale to assess the amount of pain. The scale range is from 0-10, where 0 is no pain at all and 10 is the worst pain ever had.|At enrollment prior to surgery|||units on a scale||Standard Deviation|Mean
679006|NCT01589510|Secondary|Patient Assessment of Tolerability on a 4-Point Scale|Patient assessment of tolerability was assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented.|Week 14|All patients with data for this outcome measure||Patients|||Number
679007|NCT01589510|Secondary|Physician Evaluation of IOP Lowering in the Study Eye(s)|IOP is a measurement of the fluid pressure inside the eye. Physicians evaluated IOP compared to the target IOP for each patient's study eye(s). The numbers of eyes in each category are presented.|Week 14|All patients with data for this outcome measure||Eyes|Participants||Number
679008|NCT01589510|Primary|Intraocular Pressure (IOP) at Baseline|IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Baseline.|Baseline|All patients with data for this outcome measure||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
679009|NCT01589497|Secondary|AUC, CL/F, Cmax, and C24 for Rifampicin, Isoniazid, Pyrazinamide, and Ethambutol at Day 1 and 14 and for Moxifloxacin at Day 14|pharmacokinetic parameters, AUC, CL/F, Cmax, and C24 will be examined for rifampicin, isoniazid, pyrazinamide, and ethambutol at day 1 and 14 and for moxifloxacin at day 14. The lab has started testing the samples, and the results should be available by January 2018.|Day 1 and Day 14||01/2018||||
679010|NCT01589497|Secondary|Correlation Between Time to Positivity (TTP) and log10 Transformed Colony-forming Unit (CFU) Counts Per mL|Pearson correlation coefficient was used to examine the correlation between TTP and log10 CFU among all qualified samples obtained on study|Pre-entry, Day 0, Day 1, Day 2, Day 3, Day 5, Day 7, Day 9, Day 11 and Day 14|Participants with qualified sputum samples who had results available at least one time point specified in the time-frame||correlation coefficient|||Number
679011|NCT01589497|Secondary|Log10 Transformed Colony-forming Unit (CFU) Count Per mL From Sputum Samples at Baseline and Day 14|The log10 CFU count per mL from sputum samples processed by standard method or decontaminated method.|Pre-entry, Day 0 and Day 14|Participants with qualified sputum samples who had results available at least one time point specified in the time-frame||log10 CFU/ mL||Inter-Quartile Range|Median
679012|NCT01589497|Secondary|Daily Change in Time to Positivity (TTP) From Day 2 to Day 14|"The daily change in TTP was calculated as follows:
EBA2-14(TTP) = (TTP at day 2 - TTP at day 14)/12."|Day 2 and Day 14|Participants with qualified sputum samples who had results available at all time points specified in the time-frame||hours||Inter-Quartile Range|Median
679013|NCT01589497|Secondary|Daily Change in Time to Positivity (TTP) From Baseline (Study Treatment Initiation) to Day 2|"The daily change in TTP was calculated as follows:
EBA0-2(TTP) = (baseline TTP (mean of TTP at pre-entry and day 0) - TTP at day 2)/2."|Pre-entry, Day 0 and Day 2|Participants with qualified sputum samples who had results available at all time points specified in the time-frame||hours||Inter-Quartile Range|Median
679014|NCT01589497|Secondary|Daily Change in log10 Colony-forming Unit (CFU) Counts Per mL Sputum From Day 2 to Day 14|"The daily change in log10 CFU/mL sputum was calculated as follows:
EBA2-14(CFU) = (log10 CFU/mL at day 2 - log10 CFU/mL at day 14)/12.
For a CFU/mL count of 0, the log10 CFU/mL was set to 0."|Day 2 and day 14|Participants with qualified sputum samples who had results available at all time points specified in the time-frame||log10 CFU/ mL||Inter-Quartile Range|Median
679015|NCT01589497|Secondary|Daily Change in log10 Transformed Colony-forming Unit (CFU) Counts Per mL Sputum From Baseline (Study Treatment Initiation) to Day 2|"The daily change in log10 CFU/mL sputum was calculated as follows:
EBA0-2(CFU) = (baseline log10 CFU/mL sputum (mean of log10 CFU/mL at pre-entry and day 0) - log10 CFU/mL at day 2)/2.
For a CFU/mL count of 0, the log10 CFU/mL was set to 0."|Pre-entry, Day 0 and Day 2|Participants with qualified sputum samples who had results available at all time points specified in the time-frame||log10 CFU/ mL||Inter-Quartile Range|Median
679016|NCT01589497|Secondary|Daily Change in Time to Positivity (TTP) From Baseline (Study Treatment Initiation) to Day 14|"The daily change in TTP was calculated as follows:
EBA0-14(TTP) = [baseline TTP (mean of TTP at pre-entry and day 0) – TTP at day 14]/14."|Pre-entry, Day 0 and Day 14|Participants with qualified sputum samples who had results available at all time points specified in the time-frame||hours||Inter-Quartile Range|Median
679017|NCT01589497|Primary|Daily Decrease in log10 Transformed Colony-forming Unit (CFU) Counts Per ml Sputum From Baseline (Study Treatment Initiation) to Day 14|"The daily decrease was calculated as follows:
EBA0-14(CFU)= [baseline log10 CFU/mL sputum (mean of log10 CFU/mL at pre-entry and day 0) – log10 CFU/mL at day 14]/14. For a CFU/ml count of 0, the log10 CFU/mL was set to 0.
No formal statistical testing was conducted to compare the arms. Please refer to the explanation in the Protocol Section."|Pre-entry, Day 0 and Day 14|Participants with qualified sputum samples who had results available at all time points specified in the time-frame||log10 CFU/ mL||Inter-Quartile Range|Median
679018|NCT01589484|Secondary|SWL Complications|Secondary endpoint will be SWL complications (i.e. pain, hematuria, urinary tract infection, Steinstrasse)|12 weeks after SWL|||participants|||Number
679019|NCT01589484|Primary|Stone Clearance|After 12 weeks, all patients will be submitted to a new NCCT scan to evaluate stone fragmentation and stone clearance.|12 weeks after SWL|Fragmentation||participants|||Number
679020|NCT01589445|Primary|Comparison of Changes in Fasting Serum Insulin (FSI)With Pioglitazone and Metformin|Response rate was defined by ≥10% decrease of FSG or/and ≥1% decrease of HbA1c from the baseline values after 3 months treatment.48 responded to pioglitazone and 32 responded to metformin.|3 months for each drug|After completion of both of the treatments, it is found in the 3rd month some patients didn't response according to the response rate and during result analysis the responded numbers (48 and 32)were considered only. That's why the number of participant in both the trials didn't match with number of participants analyzed.||μU/ml||Standard Deviation|Mean
679021|NCT01589445|Primary|Comparison of Changes in HOMA Percent B and HOMA Percent S With Pioglitazone and Metformin|"Response rate was defined by ≥10% decrease of FSG or/and ≥1% decrease of HbA1c from the baseline values after 3 months treatment.48 responded to pioglitazone and 32 responded to metformin.
Analysis 1: Homeostatic Model Assessment of Beta cell function(HOMA percent B) Analysis 2: Homeostatic Model Assessment of Insulin Sensitivity (Homa percent S)"|3 months for each drug|After completion of both of the treatments, it is found in the 3rd month some patients didn't response according to the response rate and during result analysis the responded numbers (48 and 32)were considered only. That's why the number of participant in both the trials didn't match with number of participants analyzed.||percentage||Standard Deviation|Mean
679148|NCT01587079|Secondary|Change From Baseline in Mean Morning Pre-dose Daily Peak Flow Readings on Day 7|Change from baseline in mean morning pre-dose daily peak flow readings|Day 7|MITT||L/min||95% Confidence Interval|Least Squares Mean
679022|NCT01589445|Primary|Comparison of Changes in Insulin Levels (HOMA IR,QUICKI) With Pioglitazone and Metformin|"Response rate was defined by ≥10% decrease of FSG or/and ≥1% decrease of HbA1c from the baseline values after 3 months treatment.48 responded to pioglitazone and 32 responded to metformin.
Analysis 1: Homeostasis Model Assessment Insulin Resistance(HOMA IR) Analysis 2: Quantitative Insulin sensitivity Check Index(QUICKI)"|3 months for each drug|After completion of both of the treatments, it is found in the 3rd month some patients didn't response according to the response rate and during result analysis the responded numbers (48 and 32)were considered only. That's why the number of participant in both the trials didn't match with number of participants analyzed.||Score on a scale ( SI unit)||Standard Deviation|Mean
679023|NCT01589445|Primary|Comparison of Changes in Glycosylated Hemoglobin (HbA1c)With Pioglitazone and Metformin|Response rate was defined by ≥10% decrease of FSG or/and ≥1% decrease of HbA1c from the baseline values after 3 months treatment.48 responded to pioglitazone and 32 responded to metformin.|3 months for each drug|After completion of both of the treatments, it is found in the 3rd month some patients didn't response according to the response rate and during result analysis the responded numbers (48 and 32)were considered only. That's why the number of participant in both the trials didn't match with number of participants analyzed.||percentage||Standard Deviation|Mean
679024|NCT01589445|Primary|Comparison of Changes in Fasting Serum Glucose (FSG)With Pioglitazone and Metformin|Response rate was defined by ≥10% decrease of FSG or/and ≥1% decrease of HbA1c from the baseline values after 3 months treatment.48 responded to pioglitazone and 32 responded to metformin.|3 months for each drug|After completion of both of the treatments, it is found in the 3rd month some patients didn't response according to the response rate and during result analysis the responded numbers (48 and 32)were considered only. That's why the number of participant in both the trials didn't match with number of participants analyzed.||mmol/l||Standard Deviation|Mean
679025|NCT01589445|Secondary|Comparison of Changes in Lipid Profiles With Pioglitazone and Metformin|"Response rate was defined by ≥10% decrease of FSG or/and ≥1% decrease of HbA1c from the baseline values after 3 months treatment.48 responded to pioglitazone and 32 responded to metformin.
Analysis 1:Total Cholesterol(TC) Analysis 2:Triglyceride(TG) Analysis 3:High Density Lipoprotein(HDL) Analysis 4:Low Density Lipoprotein(LDL)"|3 months for each drug|After completion of both of the treatments, it is found in the 3rd month some patients didn't response according to the response rate and during result analysis the responded numbers (48 and 32)were considered only. That's why the number of participant in both the trials didn't match with number of participants analyzed.||mg/dl||Standard Deviation|Mean
679026|NCT01589237|Secondary|Changes From Baseline in Apolipoprotein B-100 Levels up to 52 Weeks|Fasting blood samples were collected by direct venipuncture or an indwelling cannula to evaluate the drug effect on lipoprotein biomarkers such as Apolipoprotein B-100. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)*100.|Baseline, Week 12, 24 and 52|Full analysis set (FAS) – All subjects in the extension study who were in FAS in either study LCQ908A2212 or LCQ908B2302. At each time point post-baseline, only patients with a value at both baseline and the post-dose time point are included.||percentage change||Geometric Coefficient of Variation|Geometric Mean
679027|NCT01589237|Secondary|Changes From Baseline in Apolipoprotein B-48 Levels up to 52 Weeks|Fasting blood samples were collected by direct venipuncture or an indwelling cannula to evaluate the drug effect on lipoprotein biomarkers such as Apolipoprotein B-48. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)*100.|Baseline, Week 12, 24 and 52|Full analysis set (FAS) – All subjects in the extension study who were in FAS in either study LCQ908A2212 or LCQ908B2302. At each time point post-baseline, only patients with a value at both baseline and the post-dose time point are included.||percentage change||Geometric Coefficient of Variation|Geometric Mean
679028|NCT01589237|Secondary|Changes From Baseline in Apolipoprotein A1 Levels up to 52 Weeks|Fasting blood samples were collected by direct venipuncture or an indwelling cannula to evaluate the drug effect on lipoprotein biomarkers such as Apolipoprotein A1. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)*100.|Baseline, Week 12, 24 and 52|Full analysis set (FAS) – All subjects in the extension study who were in FAS in either study LCQ908A2212 or LCQ908B2302. At each time point post-baseline, only patients with a value at both baseline and the post-dose time point are included.||percentage change||Geometric Coefficient of Variation|Geometric Mean
679029|NCT01589237|Secondary|Changes From Baseline in Free Fatty Acid Levels up to 52 Weeks|Blood samples were collected for a fasting lipid panel, including free fatty acid level. Lipid measurements were collected after a 12 hour (overnight) fast. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)*100.|Baseline, Week 12, 24 and 52|Full analysis set (FAS) – All subjects in the extension study who were in FAS in either study LCQ908A2212 or LCQ908B2302. At each time point post-baseline, only patients with a value at both baseline and the post-dose time point are included.||percentage change||Geometric Coefficient of Variation|Geometric Mean
679082|NCT01588158|Secondary|Expectation of Pain Relief|An 11-point ordinal scale to assess the expectation of how well the pain medication will work after surgery. The scale range is from 0-10, where 0 is not effective at all and 10 is completely effective.|1 day|||units on a scale||Standard Deviation|Mean
679030|NCT01589237|Secondary|Changes From Baseline in Glycerol Levels up to 52 Weeks|Blood samples were collected for a fasting lipid panel, including glycerol level. Lipid measurements were collected after a 12 hour (overnight) fast. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)*100.|Baseline, Week 12, 24 and 52|Full analysis set (FAS) – All subjects in the extension study who were in FAS in either study LCQ908A2212 or LCQ908B2302. At each time point post-baseline, only patients with a value at both baseline and the post-dose time point are included.||percentage change||Geometric Coefficient of Variation|Geometric Mean
679031|NCT01589237|Secondary|Changes From Baseline in HDL and Non HDL Cholesterol Levels up to 52 Weeks|Blood samples were collected for a fasting lipid panel, including HDL and non HDL cholesterol level. Lipid measurements were collected after a 12 hour (overnight) fast. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)*100.|Baseline, Week 12, 24 and 52|Full analysis set (FAS) – All subjects in the extension study who were in FAS in either study LCQ908A2212 or LCQ908B2302. At each time point post-baseline, only patients with a value at both baseline and the post-dose time point are included.||percentage change||Geometric Coefficient of Variation|Geometric Mean
679032|NCT01589237|Secondary|Changes From Baseline in Cholesterol Levels up to 52 Weeks|Blood samples were collected for a fasting lipid panel, including cholesterol level. Lipid measurements were collected after a 12 hour (overnight) fast. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)*100.|Baseline, Week 12, 24 and 52|Full analysis set (FAS) – All subjects in the extension study who were in FAS in either study LCQ908A2212 or LCQ908B2302. At each time point post-baseline, only patients with a value at both baseline and the post-dose time point are included.||percentage change||Geometric Coefficient of Variation|Geometric Mean
679033|NCT01589237|Secondary|Changes From Baseline in Triglyceride Levels up to 52 Weeks|Blood samples were collected for a fasting lipid panel, including total triglycerides. Lipid measurements were collected after a 12 hour (overnight) fast. The maintenance of effect was assessed on triglyceride levels during continued therapy with LCQ908 for up to 52 weeks. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)*100.|Baseline, Week 12, 24 and 52|Full analysis set (FAS) – All subjects in the extension study who were in FAS in either study LCQ908A2212 or LCQ908B2302. At each time point post-baseline, only patients with a value at both baseline and the post-dose time point are included.||percentage change||Geometric Coefficient of Variation|Geometric Mean
679034|NCT01589237|Primary|Number of Patients With Any Adverse Events, Serious Adverse Events and Death||52 weeks|Safety set (SAF) - All subjects who received at least one dose of study drug and had at least one post-baseline safety assessment in this extension study.||Participants|||Number
679035|NCT01588951|Primary|Relapse Free Survival|Percentage of participants alive and without relapsed disease at two years.|2 years|||percentage of participants|||Number
679036|NCT01588561|Secondary|Final Nicotine Levels|Final nicotine level in each participant|30 minutes post-infusion|One participant had incomplete serum nicotine results and was not included.||ng/ml||Standard Deviation|Mean
679037|NCT01588561|Secondary|Number of Brain Regions With a Change in Brain Activity Relative to Saline When Analyzed With Smoking History Controlling for Nicotine|PhMRI analysis of the differential response of nicotine compared to the saline condition when analyzed with smoking history (pack years) controlling for nicotine. The main dependent variable in this study, Blood Oxygen Level Dependent (BOLD) measures of brain activity (via fMRI) data does not exist in a vacuum—it is always relative to another measure of brain activity, typically collected at rest or after a placebo injection. So we collected the data after the IV placebo injection alone and the IV nicotine injection alone, but then need applied mathematical CONTRASTS to the data. This procedure results in the brain activity maps.|40 minutes after infusion|The data from three subjects were not included in the imaging results, one due to incomplete serum nicotine results, one due to a misalignment of the head in the scanner, which resulted in incomplete brain coverage, and one subject had a combination of excessive motion and abnormal anatomy.||brain regions|||Number
679038|NCT01588561|Secondary|Number of Brain Regions With a Change in Brain Activity Relative to Saline When Analyzed With the Nicotine Time Course Controlling for Smoking History|"PhMRI analysis of the differential response of nicotine compared to the saline condition when analyzed with the nicotine time course controlling for smoking history (pack years).
The main dependent variable in this study, Blood Oxygen Level Dependent (BOLD) measures of brain activity (via fMRI) data does not exist in a vacuum—it is always relative to another measure of brain activity, typically collected at rest or after a placebo injection. So we collected the data after the IV placebo injection alone and the IV nicotine injection alone, but then need applied mathematical CONTRASTS to the data. This procedure results in the brain activity maps."|40 minutes after infusion|The data from three subjects were not included in the imaging results, one due to incomplete serum nicotine results, one due to a misalignment of the head in the scanner, which resulted in incomplete brain coverage, and one subject had a combination of excessive motion and abnormal anatomy.||brain regions|||Number
679083|NCT01588158|Secondary|Pain Patients Expect After Surgery|an 11-point ordinal scale to assess the amount of pain the patients expect after surgery. The scale range is from 0-10, where 0 is no pain expected and 10 is the worst pain expected|1 day|||units on a scale||Standard Deviation|Mean
679039|NCT01588561|Primary|Number of Brain Regions With a Change in Brain Activity Relative to Saline|"PhMRI analysis of the differential response of nicotine compared to the saline condition when analyzed with the nicotine time course.
The main dependent variable in this study, Blood Oxygen Level Dependent (BOLD) measures of brain activity (via fMRI) data does not exist in a vacuum—it is always relative to another measure of brain activity, typically collected at rest or after a placebo injection. So we collected the data after the IV placebo injection alone and the IV nicotine injection alone, but then need applied mathematical CONTRASTS to the data. This procedure results in the brain activity maps."|40 minutes after infusion|The data from three subjects were not included in the imaging results, one due to incomplete serum nicotine results, one due to a misalignment of the head in the scanner, which resulted in incomplete brain coverage, and one subject had a combination of excessive motion and abnormal anatomy.||brain regions|||Number
679040|NCT01588561|Primary|Peak Nicotine Levels|Peak nicotine level in each participant|0, 2, 4, 6, 8, 10, 12, 14, 16, 20, 30 minutes post-infusion|Peak nicotine levels were only measured during the nicotine study intervention. One participant had incomplete serum nicotine results and was not included.||ng/ml||Standard Deviation|Mean
679041|NCT01588548|Primary|Best Objective Response Based on RECIST Criteria (Evaluable for Response Analysis Set for RECIST Criteria)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions (TL)s since baseline and any pathological lymph nodes selected as TLs must have a reduction in short axis to <10 mm; Partial Response (PR), at least a 30% decrease in the sum of diameters of TLs; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Progressive Disease (PD), at least a 20% increase in the sum of diameters of TLs and an absolute increase of at least 5 mm; Not Evaluable (NE), this is only relevant if any of the TLs were not assessed or not evaluable or had a lesion intervention at this visit, also note that if the sum of diameters meets the progressive disease criteria, progressive disease overrides not evaluable as a TL response. Best objective response is the best response a patient experiences over the randomised treatment period.|Measurements occur at screening (<=28 days before start of study treatment), every 6 weeks (+/-1 week) up to 12 weeks and then every 12 weeks (+/-1 week) until discontinuation of study treatment or withdrawal of consent, starting from Day 1 of Cycle 1|All patients who were evaluable for Response analysis set for RECIST criteria||Participants|||Number
679042|NCT01588496|Primary|Part B: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12|LDL-C was quantified using the ultracentrifugation method.|Baseline and Week 12|Part B full analysis set (all enrolled participants who received at least 1 dose of investigational product)||percent change||Standard Error|Least Squares Mean
679043|NCT01588496|Secondary|Part B: Percent Change From Baseline in Lipoprotein (a) at the Mean of Weeks 6 and 12||Baseline and Weeks 6 and 12|Part B full analysis set||percent change||Standard Error|Least Squares Mean
679044|NCT01588496|Secondary|Part B: Percent Change From Baseline in Lipoprotein (a) at Week 12||Baseline and Week 12|Part B full anlaysis set||percent change||Standard Error|Least Squares Mean
679045|NCT01588496|Secondary|Part B: Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 6 and 12||Baseline and Weeks 6 and 12|Part B full analysis set||percent change||Standard Error|Least Squares Mean
679046|NCT01588496|Secondary|Part B: Percent Change From Baseline in Apolipoprotein B at Week 12||Baseline and Week 12|Part B full analysis set||percent change||Standard Error|Least Squares Mean
679047|NCT01588496|Secondary|Part B: Percent Change From Baseline in LDL-C at the Mean of Weeks 6 and 12|LDL-C was quantified using the ultracentrifugation method.|Baseline and Weeks 6 and 12|Part B full analysis set||percent change||Standard Error|Least Squares Mean
679048|NCT01588496|Secondary|Part A: Change From Baseline in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) at Week 12||Baseline and Week 12|Part A full analysis set||ng/mL||Standard Error|Mean
679049|NCT01588496|Secondary|Part A: Percentage of Participants With 15% or Greater Reduction in LDL-C From Baseline at Week 12|LDL-C was quantified using the ultracentrifugation method.|Baseline and Week 12|Part A full analysis set||percentage of participants|||Number
679050|NCT01588496|Secondary|Part A: Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12||Baseline and Week 12|Part A full analysis set||percent change||Standard Error|Mean
679051|NCT01588496|Secondary|Part A: Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12||Baseline and Week 12|Part A full analysis set||percent change||Standard Error|Mean
679052|NCT01588496|Secondary|Part A: Percent Change From Baseline in Apolipoprotein B at Week 12||Baseline and Week 12|Part A full analysis set||percent change||Standard Error|Mean
679053|NCT01588496|Secondary|Part A: Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12||Baseline and Week 12|Part A full analysis set||percent change||Standard Error|Mean
679054|NCT01588496|Secondary|Part A: Change From Baseline in LDL-C at Week 12|LDL-C was quantified using the ultracentrifugation method.|Baseline and Week 12|Part A full analysis set||mg/dL||Standard Error|Mean
679055|NCT01588496|Primary|Part A: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12|LDL-C was quantified using the ultracentrifugation method.|Baseline and Week 12|Part A full analysis set (all enrolled participants who received at least 1 dose of evolocumab)||percent change||Standard Error|Mean
679056|NCT01588444|Primary|Histologic Percentage of Vital Bone Formation|Histologic percentage of vital bone formation in bone cores|18-20 weeks after grafting|||percentage of vital bone||Inter-Quartile Range|Median
679057|NCT01588418|Secondary|Effect of Exenatide on the Liver and Adipose Tissue Glucose Uptake|we evaluated the acute effects of exenatide on hepatic (Hep-IR) and adipose (Adipo-IR) insulin resistance and glucose uptake.|60 minutes after exenatide or placebo injection||07/2017||||
679058|NCT01588418|Primary|Effect of Exenatide on Brain (Total Gray Matter) Glucose Metabolism|To study the acute effect of exenatide on brain glucose metabolism after the glucose load. Brain glucose uptake will be determined from serial FDG PET-imaging, by using graphical methods to quantify both global and regional results. The results obtained after Exenatide injection will be compared with the ones obtained after injection of placebo in the same subject.|120 minutes after exenatide or placebo injection|We studied, in the same subject, the acute effect of injection of exenatide vs placebo on brain glucose metabolism (CMRglu) after the glucose load. We used FDG PET-imaging to quantify global and regional results.||μmol/(ml*min)||Standard Error|Mean
679059|NCT01588405|Secondary|Change From Baseline to Week 24 in Hemodynamics Parameters: Pulmonary Vascular Resistance (PVR) (mmHg*Min/L)|pulmonary vascular resistance (PVR) is the resistance the right ventricle must overcome to pump blood into the pulmonary arteries. The change in PVR values from Baseline to Week 24 at peak exercise were measured by Swan-Ganz right heart catheterization.|Baseline and week 24|One subject completed the Week 24 visit but was unable to undergo all assessments. As such, the evaluable data at Week 24 was summarized mainly using an N of 30 subjects.||mmHg*min/L||Standard Deviation|Mean
679060|NCT01588405|Secondary|Change From Baseline to Week 24 in Hemodynamics Parameters: Pulmonary Vascular Resistance Index (PVRI) (mmHg*Min*m^2/L)|Pulmonary Vascular Resistance Index (PVRI) is calculated using Mean Pulmonary Arterial Pressure(PAPm), Pulmonary Capillary Wedge Pressure (PCWP) and Cardiac Index (CI ), to provide information about right ventricular overload. The PVRI values and their respective changes from Baseline to Week 24 at peak exercise was measured by Swan-Ganz right heart catheterization.|Baseline and week 24|One subject completed the Week 24 visit but was unable to undergo all assessments. As such, the evaluable data at Week 24 was summarized mainly using an N of 30 subjects.||mmHg*min*m^2/L||Standard Deviation|Mean
679061|NCT01588405|Secondary|Change From Baseline to Week 24 in Hemodynamics Parameters: Cardiac Index (CI) (L/Min/m^2)|Cardiac Index (CI) relates the cardiac output (CO) from left ventricle to body surface area (BSA), thus relating heart performance to the size of the individual. The CI values and their respective changes from Baseline to Week 24 at peak exercise was measured by Swan-Ganz right heart catheterization.|Baseline and week 24|Both the Thermodilution (n=6) and Fick (n=29) methods were used to determine CO and in some cases both methods were utilized; however, only the Fick method was used for (CI) for the purpose of this analysis and included only 29 subjects.||L/min/m^2||Standard Deviation|Mean
679062|NCT01588405|Secondary|Change From Baseline to Week 24 in Hemodynamics Parameters: Cardiac Output (CO) (L/Min)|Cardiac Output (CO) is the volume of blood ejected by the heart per minute, as measured by right heart catheterization. The value and change from Baseline to Week 24 at peak exercise was measured by Swan-Ganz right heart catheterization.|Baseline and week 24|One subject completed the Week 24 visit but was unable to undergo all assessments. As such, the evaluable data at Week 24 was summarized mainly using an N of 30 subjects.||L/min||Standard Deviation|Mean
679063|NCT01588405|Secondary|Change From Baseline to Week 24 in Hemodynamics Parameters: Arterial Oxygen Saturation (SaO2) (%) and Mixed Venous Oxygen Saturation (SvO2) (%)|SaO2 measured by Arterial Blood Draw and Blood Gas Analyzer and SvO2 measured via Pulmonary Artery Catheter, are both Hemodynamics Parameters collected during right heart catheterization. Mixed venous oxygen saturation (SvO2) can help to determine whether the cardiac output and oxygen delivery is high enough to meet a patient's needs|Baseline and Week 24|One subject completed the Week 24 visit but was unable to undergo all assessments. As such, the evaluable data at Week 24 was summarized mainly using an N of 30 subjects.||Percent of Oxygen saturation||Standard Deviation|Mean
679064|NCT01588405|Secondary|Change From Baseline to Week 24 in Hemodynamics Parameters: Mean Pulmonary Artery Pressure (PAPm), Mean Right Atrial Pressure (RAPm) and Mean Pulmonary Capillary Wedge Pressure (PCWPm)|Pulmonary hypertension (PH) is an increase in pressure in the pulmonary vasculature defined as a mean pulmonary artery pressure (PAPm) greater than 25 mmHg at rest or greater than 30 mmHg with exercise, as measured by right heart catheterization. Right Atrial Pressure (RAP) is the pressure of blood in the right atrium of the heart. Pulmonary Capillary Wedge Pressure (PCWP) is used to calculated pulmonary vascular resistance and can help guide therapeutic efficacy. The PAPm, RAPm and PCWPm values and their respective changes from Baseline to Week 24 at peak exercise were measured by Swan-Ganz right heart catheterization.|Baseline and week 24|One subject completed the Week 24 visit but was unable to undergo these assessments. As such, the evaluable data at Week 24 was summarized using an N of 30 subjects, which is why the number of participants analyzed is inconsistent with the participant flow module.||mmHg||Standard Deviation|Mean
679065|NCT01588405|Secondary|Change From Baseline to Week 24 in Pharmacokinetics Parameters: Area Under the Plasma Concentration Curve (AUC) [h(ng/mL)]|Treprostinil pharmacokinetics (PK) were evaluated on two occasions during this study, once while the subject was still receiving Remodulin and again at Week 24 when the subject was receiving a stable dose of oral treprostinil. Blood samples were scheduled to be drawn from each subject initially at time 0 and the following subsequent times: 2, 4, 5, 6, 8, 10 and 12 hours after time of study drug administration (time 0) for a total of eight samples.|Baseline and Week 24|The number of participants analyzed is inconsistent with participant flow because it includes data from an early termination patient. A pharmacokinetics sample collected at early termination was included in the analysis.||[h(ng/mL)]||Full Range|Median
679066|NCT01588405|Secondary|Change From Baseline to Week 24 in Pharmacokinetics Parameter: Peak Time to Reach Peak Plasma Concentration [Tmax (h)]|Treprostinil pharmacokinetics (PK) were evaluated on two occasions during this study, once while the subject was still receiving Remodulin and again at Week 24 when the subject was receiving a stable dose of oral treprostinil. Blood samples were scheduled to be drawn from each subject initially at time 0 and the following subsequent times: 2, 4, 5, 6, 8, 10 and 12 hours after time of study drug administration (time 0) for a total of eight samples.|Baseline and Week 24|Dosing frequency was modified for BID to TID during the study, reported separately for patients on BID vs TID dosing at week 24. The number of participants analyzed is inconsistent with participant flow because it includes data from an early termination patient. A pharmacokinetics sample collected at early termination was included in the analysis.||[Tmax (h)]||Full Range|Mean
679067|NCT01588405|Secondary|Change From Baseline to Week 24 in Pharmacokinetic Parameters: Peak Plasma Concentration (Cmax), Average Plasma Concentration (Cavg), and Trough Plasma Concentration (Cmin)|Treprostinil pharmacokinetics (PK) were evaluated on two occasions during this study, once while the subject was still receiving Remodulin and again at Week 24 when the subject was receiving a stable dose of oral treprostinil. Blood samples were scheduled to be drawn from each subject initially at time 0 and the following subsequent times: 2, 4, 5, 6, 8, 10 and 12 hours after time of study drug administration (time 0) for a total of eight samples.|Baseline and Week 24|Dosing frequency was modified for BID to TID during the study, reported separately for patients on BID vs TID dosing at week 24. The number of participants analyzed is inconsistent with participant flow because it includes data from an early termination patient. A pharmacokinetics sample collected at early termination was included in the analysis.||(ng/mL)||Full Range|Median
679084|NCT01588158|Secondary|PHQ-9|Patient Health Questionnaire-9 to assess symptoms of depression. The scale range is from 0-27, where 0 is no symptoms of depression and 27 is severe depression.|1 day|||units on a scale||Standard Deviation|Mean
679068|NCT01588405|Secondary|Change in Dyspnea-fatigue Index From Baseline to Week 24|The dyspnea-fatigue index has three components, each rated on a scale of 0 to 4, for the magnitude of the task that evokes dyspnea or fatigue, the magnitude of the pace (or effort) with which the task is performed and the associated functional impairment in general activities. The ratings for each component were added to form an aggregate score, which could range from 0, for the worst condition, to 12, for the best.|Baseline and Week 24|||units on a scale||Full Range|Median
679069|NCT01588405|Secondary|Change in World Health Organization (WHO) Functional Classification From Baseline to Week 24|Class I: No limitation of physical activity. Class II: Slight limitation of physical activity. Class III: Marked limitation of physical activity. Class IV: Inability to carry out any physical activity without symptoms.|Baseline and Week 24|The World Health Organization (WHO) Functional Classification was only conducted at baseline for one subject, because the subject discontinued the study prior to the collection of this assessment at the next visit. One subject had this assessment prior to study discontinuation.||participants|||Number
679070|NCT01588405|Secondary|Change in Quality of Life (QoL) Assessment: Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) From Baseline to Week 24|The CAMPHOR is a health related quality of life instrument validated for pulmonary hypertension that assesses impairment (symptoms), disability (activities) and quality of life. The questionnaire is divided into three sections; Symptoms (Scores 0-25; high scores indicate more symptoms), Activity (Score 0-30; low score indicates good functioning) and Quality of Life (0-25; high scores indicate poor QoL). The sum of these scores equates to the Total score (0-80). In the CAMPHOR scores, lower scores indicate improvements.|Baseline and week 24|||units on a scale||Full Range|Median
679071|NCT01588405|Secondary|Change in Borg Dyspnea Score (Following 6MWT) From Baseline to Week 24|The Borg dyspnea score is a 10-point scale rating the maximum level of dyspnea (difficulty in breathing) experienced during the six-minute walk test (6MWT). The Borg dyspnea score was assessed immediately following the 6MWT. Scores ranged from 0 (for no shortness of breath) to 10 (for the greatest shortness of breath ever experienced).|Baseline and week 24|One subject completed the Week 24 visit but was unable to undergo all assessments. As such, the evaluable data at Week 24 was summarized mainly using an N of 30 subjects.||units on a scale||Full Range|Median
679072|NCT01588405|Secondary|Change From Baseline in Six-minute Walk Distance at Week 24|The purpose of the 6MWT is to evaluate exercise capacity associated with carrying out activities of daily living. Patients were instructed to walk down a corridor at a comfortable speed as far as they could manage for six minutes, resting whenever they needed. Distance <500 meters suggests considerable exercise limitation; Distance 500-800 meters suggests moderate limitation; Distance >800 meters (with no rests) suggests mild or no limitation.|Baseline and week 24|One subject completed the Week 24 visit but was unable to undergo all assessments. As such, the evaluable data at Week 24 was summarized mainly using an N of 30 subjects.||meters||Full Range|Median
679073|NCT01588405|Primary|Number of Participants That Were Succesfully Transitioned From Parenteral Remodulin to UT-15C.|Successful transition was based on the number of participants that completely transitioned to oral treprostinil by the week 4 study visit and clinically maintained on oral treprostinil treatment through Week 24.|Up to 24 weeks|||participants|||Number
679074|NCT01588353|Secondary|Time to First Achieve and Maintain Clinical Success After the Last Injection|"The Secondary Outcome Measure for participants who were enrolled at Step1 through Step2 and treated with AK160 is the time to first achieve and maintain clinical success after the last injection where clinical success was defined as reduction in the contracture of the first treated joint to 5° or less. The injection was allowed up to 3 times."|First evaluation visit on which clinical success is achieved and maintained through the Day 30 evaluation of each injections, assessed up to 3 months|The secondary efficacy analysis population was the full analysis set (FAS) comprising subjects treated with study drug in Steps 1 and 2.||Days||Inter-Quartile Range|Median
679075|NCT01588353|Secondary|Change From Baseline Range of Motion After the Last Injection|The Secondary Outcome Measure for participants who were enrolled at Step1 through Step2 and treated with AK160 is the change from baseline range of motion in primary joints after the last injection. The injection was allowed up to 3 times.|30 days after last treatment|The secondary efficacy analysis population was the full analysis set (FAS) comprising subjects treated with study drug in Steps 1 and 2.||Degrees||Standard Deviation|Mean
679076|NCT01588353|Secondary|Percent Reduction From Baseline Contracture After the Last Injection|The Secondary Outcome Measure for participants who were enrolled at Step1 through Step2 and treated with AK160 is the mean percent decrease from baseline degree of contracture in primary joints after the last injection. The injection was allowed up to 3 times.|30 days after last treatment|The secondary efficacy analysis population was the full analysis set (FAS) comprising subjects treated with study drug in Steps 1 and 2.||% of change from baseline||Standard Deviation|Mean
679077|NCT01588353|Secondary|Clinical Improvement After the Last Injection|"The Secondary Outcome Measure for participants who were enrolled at Step1 through Step2 and treated with AK160 is the percentage of 77 participants that were clinically improved where clinically improved was defined as reduction in the contracture of the first treated joint by 50% or more from the baseline. The injection was allowed up to 3 times."|30 days after the last injection|The secondary efficacy analysis population was the full analysis set (FAS) comprising subjects treated with study drug in Steps 1 and 2.||% Participants||95% Confidence Interval|Number
679078|NCT01588353|Primary|"The Percentage of Participants That Were Successfully Treated With a Successful Reduction in Contracture to 5°or Less"|"The Primary Outcome Measure for participants who were enrolled at Step1 through Step2 and treated with AK160 is the percentage of 77 participants that were successfully treated where successfully treated was defined as reduction in the contracture of the first treated joint to 5° or less. The injection was allowed up to 3 times."|30 days after the last injection|The primary efficacy analysis population was the full analysis set (FAS) comprising subjects treated with study drug in Steps 1 and 2.||% Participants|||Number
679079|NCT01588158|Secondary|Pain Scale|11-point ordinal pain scale to assess the amount of pain. The scale range is from 0-10, where 0 is no pain at all and 10 is the worst pain ever had.|At the follow-up 2 weeks after the surgery with suture removal|||units on a scale||Standard Deviation|Mean
679080|NCT01588158|Secondary|QuickDASH|The short form of the Disabilities of Arm Shoulder and Hand to assess upper extremity disability. The scale range is from 0-100, where 0 is no difficulty performing tasks and 100 is the most difficulty or unable to complete any tasks.|At the follow-up 2 weeks after the surgery with suture removal|||units on a scale||Standard Deviation|Mean
679086|NCT01588158|Secondary|QuickDASH|The short form of the Disabilities of Arm Shoulder and Hand to assess upper extremity disability. The scale range is from 0-100, where 0 is no difficulty performing tasks and 100 is the most difficulty or unable to complete any tasks.|At enrollment prior to surgery|Due to early termination of the study, the participants were not analyzed so we do not have data to enter in the outcome measure data table.||units on a scale||Standard Deviation|Mean
679087|NCT01588158|Primary|Satisfaction With Pain Relief|an 11-point ordinal scale to ask for the satisfaction of the patients with pain relief. The scale range is from 0-10, where 0 is complete dissatisfaction with pain relief and 10 is complete satisfaction.|at the follow-up, 2 weeks after the operation with suture removal|||units on a scale||Standard Deviation|Mean
679088|NCT01588106|Primary|Reduction in HbA1c||Baseline, after 9 months|All participants from whom HbA1c measurements were recorded at baseline and after 9 months.||% (unit of HbA1c)||Standard Deviation|Mean
679089|NCT01587989|Secondary|Participant Satisfaction With Treatment as Assessed by Treatment Satisfaction Questionnaire for Medication (TSQM) Score|TSQM scores were obtained by scoring participants’ responses to a 14-item questionnaire. TSQM evaluated 4 aspects of treatment satisfaction: effectiveness, side effects, convenience, and global satisfaction from a range of 0 to 100 percent (%), with 100% being the best possible result.|Week 24|ITT population||score on a scale||Standard Deviation|Mean
679090|NCT01587989|Secondary|Change From Week 12 (Randomization) to Week 24 in Visual Analog Scales (VAS) Scores|VAS scores were obtained by scoring participants’ disease activity as assessed on a 0-100 millimeter (mm) horizontal visual scale. The left-hand extreme of the line = 0 mm (no disease activity = symptom-free and no arthritis symptoms), and the right-hand extreme of the line = 100 mm (maximum disease activity). A negative change from randomization indicated improvement.|Weeks 12 and 24|ITT population||score on a scale||Standard Deviation|Mean
679091|NCT01587989|Secondary|Change From Week 12 (Randomization) to Week 24 in Short Form-36 Health Survey (SF-36) Score|SF-36 scores were obtained by scoring participants' responses to a 36-item questionnaire. SF-36 evaluated 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health from a range of 1 (better) to 5 (worst). The score for each section was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). These 8 aspects were summarized as physical and mental component scores. A negative change from randomization indicated improvement.|Weeks 12 and 24|ITT population||score on a scale||Standard Deviation|Mean
679092|NCT01587989|Secondary|Change From Week 12 (Randomization) to Week 24 in Health Assessment Questionnaire – Disability Index (HAQ-DI) Score|HAQ-DI scores were obtained by scoring participants’ responses to a 20-item questionnaire. HAQ-DQ evaluated 8 domains of health: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities from a range of 0 (without any difficulty) to 3 (unable to do). The sum of scores was divided by the number of domains for a total score of 0 (best) to 3 (worst). A negative change from randomization indicated improvement.|Weeks 12 and 24|ITT population||score on a scale||Standard Deviation|Mean
679093|NCT01587989|Secondary|Percentage of Participants With Rheumatoid Arthritis Disease Activity Index-5 (RADAI-5) Remission at Week 24|The RADAI-5 is a combined index for measuring disease activity in RA. RADAI-5 is comprised of the following 5 questions: how active was your arthritis the last 6 months? (0 = completely inactive to 10 = extremely active); how active is your arthritis today with respect to joint tenderness and swelling? (0 = completely inactive to 10 = extremely active); how severe is your arthritis pain today? (0 = no pain to 10 = unbearable pain); how would you describe your general health today? (0 = very good to 10 = very bad); and did you experience joint (hand) stiffness on awakening yesterday morning? If yes, how long did this stiffness last? (0 = no stiffness to 10 = stiffness the whole day). RADAI was calculated according to the following formula: [question (Q) 1 + Q2 + Q3 + Q4 + Q5]/5. RADAI-5 from 0-1.4 = remission.|Week 24|ITT population||percentage of participants|||Number
679094|NCT01587989|Secondary|Percentage of Participants With Simplified Disease Activity Index (SDAI) Remission at Week 24|The SDAI is a combined index for measuring disease activity in RA. SDAI is the sum of TJC and SJC, both scored 0-28 (higher scores indicate higher disease activity), PGA and EGA of disease activity, both scored 0 to 10 cm as assessed by VAS, and C-reactive protein level (CRP) in milligrams per deciliter (mg/dL) where normal < 1 mg/dL. CDAI was calculated according to the following formula: SDAI = TJC + SJC + PGA + EGA + CRP. SDAI < 3.3 = remission.|Week 24|ITT population||percentage of participants|||Number
679095|NCT01587989|Secondary|vPercentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Week 24|The CDAI is a combined index for measuring disease activity in RA. CDAI is the sum of TJC and SJC, both scored 0-28 (higher scores indicate higher disease activity), as well as patient global assessment (PGA) and evaluator global assessment (EGA) of disease activity, both scored 0 to 10 centimeter (cm) as assessed by VAS. CDAI was calculated according to the following formula: CDAI = SJC + TJC + PGA + EGA. CDAI < 2.8 = remission.|Week 24|ITT population||percentage of participants|||Number
679096|NCT01587989|Secondary|Percentage of Participants With DAS28 Remission at Week 24|The DAS28 is a combined index for measuring disease activity in RA. The index includes SJC and TJC, both scored 0-28 (higher scores indicate higher disease activity, as well as APR determined as ESR, and GH, both scored 1-100 (higher scores indicate higher disease activity). DAS28 was calculated according to the following formula: DAS28 = 0.56 * √ of TJC + 0.28 * √ of SJC + 0.70 * ln ESR mm/hr + 0.014 * GH in mm VAS. DAS28 < 2.6 = remission.|Week 24|ITT population||percentage of participants|||Number
679097|NCT01587989|Primary|Change From Week 12 (Randomization) to Week 24 in DAS28|The DAS28 is a combined index for measuring disease activity in rheumatoid arthritis (RA). The index includes swollen joint counts (SJC) and tender joint counts (TJC), both scored 0-28 (higher scores indicate higher disease activity), as well as acute phase response (APR) determined as erythrocyte sedimentation rate (ESR), and general health (GH), both scored 1-100 (higher scores indicate higher disease activity). DAS28 was calculated according to the following formula: DAS28 equals (=) [0.56 multiplied by (*) the square root (√) of TJC] plus (+) [0.28 * √ of SJC] + (0.70 * the natural logarithm (ln) ESR in millimeters per hour (mm/h)] + [0.014 * GH in mm visual analogue assessment (VAS)]. A negative change from randomization indicated improvement.|Weeks 12 and 24|ITT population||score on a scale||Standard Deviation|Mean
679149|NCT01587079|Secondary|Change From Baseline at Evening 12-hour Post-dose Trough FEV1 on Day 7|Change from baseline at evening 12-hour post-dose trough FEV1|Day 7|MITT||Millliters||95% Confidence Interval|Least Squares Mean
679098|NCT01587963|Primary|Efficacy of High Dose Vitamin C Therapy in Shock Patients|Given the grim prognosis of septic and hypovolemic shock, we aim to study the efficacy on an alternative treatment modality by implementing high dose vitamin C therapy in our patient population. Through previous investigations, especially research in the burn patient population, we expect that high dose vitamin C therapy will be beneficial to patients with hypovolemic or septic shock.|30 days|Study terminated prior to data collection completion. No data analysis performed.|||||
679099|NCT01587950|Primary|Adjusted Mean Change From Baseline in Evaporative Sensitivity Pain Response of Hypersensitive Tooth on a VAS, 20 Minute Post Application of 5% KNO3 Solution, 2.5% KNO3 Solution and Sterile Water|Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score at 20 minutes post treatment.|Baseline, 20 minutes post administration of treatment|ITT population: All randomized subjects with at least one post baseline assessment of efficacy were included in analysis. Missing data was not imputed. Due to missing values, there were differences in number of participant analyzed per treatment group.||Units on a scale||95% Confidence Interval|Mean
679100|NCT01587950|Primary|Adjusted Mean Change From Baseline in Evaporative Sensitivity Pain Response of Hypersensitive Tooth on a VAS, 10 Minutes Post Application of 5% KNO3 Solution, 2.5% KNO3 Solution and Sterile Water|Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score at 10 minutes post treatment.|Baseline, 10 minutes post administration of treatment|ITT population: All randomized subjects with at least one post baseline assessment of efficacy were included in analysis. Missing data was not imputed. Due to missing values, there were differences in number of participant analyzed per treatment group.||Units on a scale||95% Confidence Interval|Mean
679101|NCT01587950|Primary|Adjusted Mean Change From Baseline in Evaporative Sensitivity Pain Response of Hypersensitive Tooth on a Visual Analogue Scale (VAS) Immediately Post Application of 5% KNO3 Solution, 2.5% KNO3 Solution and Sterile Water|Response to a constant jet of air applied to a hypersensitive tooth was evaluated using a 100 millimeter (mm) VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score immediately post treatment.|Baseline, immediately post administration of treatment|Intent to treat (ITT) population: All randomized subjects with at least one post baseline assessment of efficacy were included in analysis. Missing data was not imputed. Due to drop outs, there was difference in number of participant analyzed.||Units on a scale||95% Confidence Interval|Mean
679102|NCT01587924|Secondary|Number of Participants With Electrocardiogram (ECG) Findings Over Period|Participants were analyzed for any abnormality in ECG and was categorized as abnormal clinically significant and abnormal and clinically insignificant. The parameters that were analyzed for ECG were atrial fibrillation, Atrial premature complex, Bigeminy, First degree AV block (PR interval > 200 msec), Incomplete right bundle branch block, Junctional rhythm, Junctional tachycardia (heart rate >100 beats/min), Left anterior hemi block (synonymous to left anterior fascicular block), Left atrial abnormality, Left axis deviation (QRS axis more negative than -30 degrees), Left bundle branch block, Left ventricular hypertrophy, Myocardial infarction, anterior, Myocardial infarction, inferior, Non-specific ST-T changes, Normal sinus rhythm, Poor R wave progression, Right atrial abnormality, Right QRS axis deviation, bundle block, ventricular hypertrophy, ST depression or abnormality, AV block, arrhythmia, short PR interval, bradycardia, tachycardia, and T-wave abnormality.|Up to 6 weeks|Safety population. Only the participants available at the time of assessment were analyzed.||Participants|||Count of Participants
679103|NCT01587924|Secondary|Number of Participants With Abnormal Vital Signs of PCI|Participants were analyzed for any abnormality in vital signs of diastolic blood pressure (DBP), systolic blood pressure (SBP), and heart rate (HR); whether any of the these values were of PCI.|Up to 6 weeks|Safety population. Only the participants available at the time of assessment were analyzed.||Participants|||Count of Participants
679104|NCT01587924|Secondary|Number of Participants With Abnormal Hematology and Clinical Chemistry Parameters of Potential Clinical Concern (PCI)|Participants were analyzed up to 6 weeks for hematological and clinical chemistry parameters of potential clinical concern (PCC) whether they had any higher (H) or lower (L) values than the reference range (RR) post screening. Normal alkaline phosphatase (ALP) was 0-46 U/L, AST 0-42 U/L, ALP 20-125 U/L, total bilirubin 0-1.3 mg/dL, troponin 0-0.1ng/mL, hemoglobin 12 - 16 g/dL, platelets 140-450 G/L, creatine phosphokinase 29-168 U/L, creatinine 0.57 - 1.25 mg/dL, Potassium 3.6-5.0 mmol/L, hematocrit 38-45%; however, no participants with abnormal hematology and clinical chemistry parameters were recorded.|Up to 6 weeks (including follow-up)|Safety population included all participants who received at least one dose of study drug.||Participants|||Count of Participants
679105|NCT01587924|Secondary|Mean Plasma Concentration of GSK1278863 and GSK1278863 Metabolites Over 4 Weeks|Each of the plasma concentration-time plot contained one plot on the untransformed scale (i.e. a linear plot) and one plot on the log transformed scale (i.e. log-linear plot). Plasma concentrations were analyzed for the study drug (GSK1278863), and its metabolites namely GSK2391220 (M2), GSK2531403 (M3), GSK2487818A (M4), GSK2506102A (M5), GSK2531398 (M6), and GSK2531401A (M13). Pharmacokinetic analysis was done on Weeks (W) 2 and 4 at a fixed timely interval of 5 hours (h) on W2 and every hour on W4. Only the data for last visit for W2 and last visit of W4 has been presented.|Up to 4 weeks|Pharmacokinetic (PK) population included all the participants who received at least one dose of the study drug and from whom at least one sample was withdrawn for PK analysis. Only those participants available at the specified time points were analyzed.||Nanograms per milliliter (ng/mL)||Standard Deviation|Mean
679106|NCT01587924|Secondary|Number of Participants Discontinuing the Study Treatment Due to AEs|Discontinuation of the study drug could be due to safety-related reasons AE. The AEs responsible included anemia, gastrointestinal hemorrhage, and nausea.|Up to 4 weeks|Safety population||Participants|||Count of Participants
679150|NCT01587079|Secondary|Peak Change From Baseline IC on Day 7|Peak change from baseline IC|Day 7|MITT||Millliters||95% Confidence Interval|Least Squares Mean
679151|NCT01587079|Secondary|Change From Baseline in Morning Pre-dose Trough IC on Day 7|Change from baseline in morning pre-dose trough IC|Day 7|MITT||Millliters||95% Confidence Interval|Least Squares Mean
679107|NCT01587924|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is an unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain time period after the study has ended. This change may or may not be caused by the intervention being studied. An SAE is an adverse event that results in death, is life-threatening, requires inpatient hospitalization or extends a current hospital stay, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect. Medical events that do not result in death, are not life-threatening, or do not require hospitalization may be considered serious adverse events if they put the participant in danger or require medical or surgical intervention to prevent one of the results listed above. Only on-treatment data has been presented.|Up to 4 weeks|Safety population.||Participants|||Count of Participants
679108|NCT01587924|Secondary|Number of Participants Reaching Hemoglobin Stopping Criteria|Participants were analyzed whether they had any increase or decrease from the Baseline hemoglobin (BL Hb). Hemoglobin increase based stopping criteria included analysis of Increase or decrease of more than or equal to (>=) 2 g/dL from the Baseline (pre-dose on Day 1) was recorded and also the participants with hemoglobin >=13 g/dL were recorded.|Up to 4 weeks|ITT population. Only those participants available at the time of assessment were analyzed.||Participants|||Count of Participants
679109|NCT01587924|Secondary|Change From Baseline (Pre-dose on Day 1) for Reticulocytes Over 4 Weeks|Evaluation of change from Baseline for red blood cells was a PD parameter. Change from Baseline is the value at indicated time point minus the Baseline value. Baseline value was recorded pre-dose on Day 1.|Baseline (pre-dose on Day 1) and up to 4 weeks|ITT population. Only those participants available at the specified time points were analyzed.||Percentage change||Standard Deviation|Mean
679110|NCT01587924|Secondary|Change From Baseline (Pre-dose on Day 1) for Red Blood Cells Over 4 Weeks|Change from Baseline in red blood cells (RBCs) was a pharmacodynamic (PD) biomarker. Change from Baseline is the value at indicated time point minus the Baseline value. Baseline was recorded pre-dose on Day 1. Change from Baseline (pre-dose on Day 1) in red blood cells was calculated over 4 weeks.|Baseline (pre-dose on Day 1) and up to 4 weeks|ITT population. Only those participants available at the specified time points were analyzed.||10^12 cells per Liter (Giga cells per L)||Standard Deviation|Mean
679111|NCT01587924|Secondary|Change From Baseline (Pre-dose on Day 1) in Total Iron Binding Capacity Over 4 Weeks|Evaluation of change from Baseline in total iron binding capacity was performed over 4 weeks. Baseline was recorded pre-dose on Day 1. Change from Baseline is the value at indicated time point minus the Baseline value. Adjusted means are presented as LS means.|Baseline (pre-dose on Day 1) and Week 4|ITT population. Only those participants available at the specified time points were analyzed.||Micromoles per Liter||Standard Error|Least Squares Mean
679112|NCT01587924|Secondary|Change From Baseline (Pre-dose on Day 1) for Total Iron Over 4 Weeks|Evaluation of change from Baseline for total iron was performed over 4 weeks. Change from Baseline is the value at indicated time point minus the Baseline value. Baseline was recorded pre-dose on Day 1. Adjusted mean was presented as LS mean.|Baseline (pre-dose on Day 1) and at Week 4|ITT population. Only those participants available at the specified time points were analyzed.||Micromoles per Liter||Standard Error|Least Squares Mean
679113|NCT01587924|Secondary|Change From Baseline (Pre-dose on Day 1) for Transferrin Saturation Over 4 Weeks|Evaluation of change from baseline for transferrin saturation was performed up to 4 weeks. Change from Baseline is the value at indicated time point minus the Baseline value. Baseline value was recorded pre-dose on Day 1. Model adjusted mean values are presented as LS mean values.|Baseline (pre-dose on Day 1) and Week 4|ITT population. Only those participants available at the specified time points were analyzed..||Ratio||Standard Error|Least Squares Mean
679114|NCT01587924|Secondary|Evaluation of Change From Baseline (Pre-dose on Day 1) for Transferrin Over 4 Weeks|Evaluation of change from Baseline for ferritin was performed over 4 weeks. Change from Baseline is the value at indicated time point minus the Baseline value. Model adjusted mean has been presented as LS mean.|Baseline (pre-dose on Day 1) and Week 4|ITT population. Only those participants available at the specified time points were analyzed.||Grams per liter||Standard Error|Least Squares Mean
679115|NCT01587924|Secondary|Evaluation of Change From Baseline (Pre-dose on Day 1) in Ferritin Over 4 Weeks|Change from Baseline (pre-dose on Day 1) in ferritin over 4 weeks was analyzed. Change from Baseline is the value at indicated time point minus the Baseline value. Model adjusted mean has been presented as LS mean.|Baseline (pre-dose on Day 1) and Week 4|ITT population. Only those participants available at the specified time points were analyzed.||Micrograms per liter||Standard Error|Least Squares Mean
679116|NCT01587924|Secondary|Number of Days Spent Within Hgb Range ( ±0.5 g/dL and ±1 g/dL ) From Baseline Hgb|Time spent with Hgb within range (where range was defined as +-0.5 g/dL and +-1 g/dL from baseline Hgb ) was analyzed. Baseline value of Hgb was recorded pre-dose on Day 1.|Baseline (pre-dose on Day 1) and up to 4 weeks|ITT population. Only those participants available at the specified time points were analyzed.||Days||Inter-Quartile Range|Median
679117|NCT01587924|Secondary|Residual Standard Deviation in Hgb (From the Linear Regression)|Residual standard deviation was derived by linear regression. Hgb of participants was recorded over 4 weeks|Up to 4 weeks|ITT population. Only those participants available at the specified time points were analyzed.||g/L||Standard Deviation|Mean
679118|NCT01587924|Secondary|Evaluation of Change From Baseline (Pre-dose on Day 1) for Hematocrit Over 4 Weeks|Evaluation of change from Baseline for hematocrit over 4 weeks was performed. Change from Baseline is the value at indicated time point minus the Baseline value.|Baseline (pre-dose on Day 1) and up to 4 weeks|ITT population. Only those participants available at the specified time points were analyzed.||Percentage||Standard Deviation|Mean
679119|NCT01587924|Secondary|Evaluation of Change From Baseline (Pre-dose on Day 1) for Peak Vascular Endothelial Growth Factor (VEGF) Over 4 Weeks|Evaluation of change from Baseline for peak VEGF was analyzed up to 4 weeks. Baseline assessment was performed pre-dose on Day 1. Change from Baseline is the value at indicated time point minus the Baseline value. Absolute mean change and peak change from Baseline in peak VGEF were also calculated; however, only model adjusted peak change in peak VGEF from Baseline has been presented as LS means.|Baseline (pre-dose on Day 1) and up to 4 weeks|ITT population. Only those participants available at the specified time points were analyzed.||Nanograms per liter (ng/L)||Standard Error|Least Squares Mean
679152|NCT01587079|Secondary|Peak Change From Baseline in FEV1 on Day 7|Peak change from baseline in FEV1 Day 7|Day 7|MITT||Millliters||95% Confidence Interval|Least Squares Mean
679120|NCT01587924|Secondary|Change From Baseline for Erythropoeitin (EPO) Over Period|Evaluation of change from Baseline (pre-dose on Day 1) for EPO was analyzed over 4 weeks. Change from Baseline is the value at indicated time point minus the Baseline value. Baseline was the pre-dose Day 1 value. Adjusted means are presented as LS means.|Baseline (pre-dose on Day 1) and up to 4 weeks|ITT population. Only those participants available at the specified time points were analyzed.||Units per liter (U/L)||Standard Error|Least Squares Mean
679121|NCT01587924|Secondary|Evaluation of Change From Baseline (Pre-dose on Day 1) in High Sensitivity C-Reactive Protein (hsCRP) Over 4 Weeks|Evaluation of change from Baseline for hsCRP was analyzed over 4 weeks. Change from Baseline is the value at indicated time point minus the Baseline value. Baseline was the last pre-dose value. Peak change from Baseline also was calculated; however adjusted mean change from Baseline has been presented here as LS means.|Baseline (pre-dose on Day 1) and up to 4 weeks|ITT population. Only those participants available at the specified time points were analyzed.||Milligrams per liter (mg/L)||Standard Error|Least Squares Mean
679122|NCT01587924|Secondary|Evaluation of Change From Baseline in Hepcidin Over Period|Evaluation of change from baseline for hepcidin was performed over 4 weeks. Change from Baseline is the value at indicated time point minus the Baseline value. Baseline was the last pre-dose value. Adjusted mean change from Baseline is presented as Least square (LS) mean.|Baseline (pre-dose on Day 1) and up to 4 weeks|ITT population. Only those participants available at the specified time points were analyzed.||Micrograms per liter (mcg/L)||Standard Error|Least Squares Mean
679123|NCT01587924|Secondary|Hgb Variability Over 4 Weeks|Within participant standard deviation for Hgb acts as a measure of Hgb variability. Hgb of participants was recorded over 4 weeks.|Up to 4 weeks|ITT population. Only those participants available at the specified time points were analyzed.||g/dL||Standard Deviation|Mean
679124|NCT01587924|Primary|Modeled Hgb Change From Baseline (Pre-dose on Day 1) at 4 Weeks of Treatment|Modeled Hgb change from Baseline over 4 weeks of treatment. Change from Baseline is the actual value of Hgb at Week 4 minus the Baseline value. For modeled change at Week 4 participants required a Baseline and two or more non missing post-baseline values. Baseline is the average of Week -2, -1 and Day 1 values. The model included fixed effects for Baseline Hgb, treatment, and treatment by day interaction. Covariate analysis for modeled Hgb change was performed. Random effects were fitted in the intercept and the slope over time.|Baseline (pre-dose on Day 1) and up to week 4|ITT population. Only those participants available at the specified time points were analyzed.||Grams per deciliter (g/dL)||Standard Deviation|Mean
679125|NCT01587885|Secondary|Percentage of Participants Affected By Heartburn Symptoms: End of Treatment Quality of Life Questionnaire|End of Treatment Quality of Life was based on a questionnaire regarding quality-of-life issues associated with heartburn, completed by participants at the end of treatment period 1 and the end of treatment period 2.|End of treatment period 1 and end of treatment period 2|Participants in the mITT population, consisting of all randomized participants who received study drug and who provided efficacy data for at least one of the study drugs for the variable and time point analyzed.||percentage of partcipants|||Number
679126|NCT01587885|Secondary|Number of Participants Preferring Each Treatment Overall: Final Subjective Questionnaire|Participants completed a Final Subjective Questionnaire for Treatment Preference. Question 3 asked participants to compare the 2 treatments for their overall preference.|At end of study (approx. Study Day 40)|Participants in the ITT population, consisting of all participants who were randomized, took study medication at the beginning of treatment period 1, and provided data.||participants|||Number
679127|NCT01587885|Secondary|Number of Participants Preferring Each Treatment for Heartburn Relief: Final Subjective Questionnaire|Participants completed a Final Subjective Questionnaire for Treatment Preference. Question 2 asked participants to compare the 2 treatments for Heartburn Relief.|At end of study (approx. Study Day 40)|Participants in the ITT population, consisting of all participants who were randomized, took study medication at the beginning of treatment period 1, and provided data.||participants|||Number
679128|NCT01587885|Secondary|Number of Participants Preferring Each Treatment for Heartburn Control: Final Subjective Questionnaire|Participants completed a Final Subjective Questionnaire for Treatment Preference. Question 1 asked participants to compare the 2 treatments for Heartburn Control.|At end of study (approx. Study Day 40)|Participants in the Intent-to-Treat (ITT) population, consisting of all participants who were randomized, took study medication at the beginning of treatment period 1, and provided data.||participants|||Number
679129|NCT01587885|Secondary|Percentage of Participants Experiencing Onset and Demonstrating Duration of Heartburn Relief Over Time|"Onset of heartburn relief was defined as a reduction of at least one grade from baseline in the severity of heartburn following start of treatment. Severity of heartburn was evaluated by the participant using the 4-point Likert Scale, which rated heartburn severity as follows:
Absent (0): Heartburn is not present.
Mild (1): Heartburn did not last long or was easily tolerated.
Moderate (2): Heartburn caused discomfort and interrupted usual activities.
Severe (3): Heartburn caused great interference with usual activities and may have been incapacitating."|Start of treatment until onset of heartburn relief, up to 72 hours|"Participants in the mITT population, consisting of all randomized participants who received study drug and who provided efficacy data for at least one of the study drugs for the variable and time point analyzed.
One participant completed the study but the participant's data was corrupted and therefore not included."||percentage of participants|||Number
679130|NCT01587885|Primary|Time-to-onset of Heartburn Relief|"Time-to-onset of heartburn relief was defined as earliest time following start of treatment that participant experienced a reduction of at least one grade from baseline in the severity of heartburn. Severity of heartburn was evaluated by the participant using the 4-point Likert Scale, which rated heartburn severity as follows:
Absent (0): Heartburn is not present.
Mild (1): Heartburn did not last long or was easily tolerated.
Moderate (2): Heartburn caused discomfort and interrupted usual activities.
Severe (3): Heartburn caused great interference with usual activities and may have been incapacitating."|Start of treatment until onset of heartburn relief, up to 24 hours|"Participants in the modified Intent-to-Treat (mITT) population, consisting of all randomized participants who received study drug and who provided efficacy data for at least one of the study drugs for the variable and time point analyzed.
One participant completed the study but the participant's data was corrupted and therefore not included."||Minutes||Inter-Quartile Range|Median
679153|NCT01587079|Secondary|Change From Baseline in Morning Pre-dose Trough FEV1 on Day 7|Change from baseline in morning pre-dose trough FEV1|Day 7|MITT||Milliliters||95% Confidence Interval|Least Squares Mean
679131|NCT01587651|Secondary|Percentage of Subjects With High On-treatment Platelet Reactivity|"Percentage of subjects with High on-treatment Platelet Reactivity (HPR) defined as a) >= 208 PRU and b) >= 230 PRU by the VerifyNow P2Y12 assay and c) >50% PRI by the VASP assay, 2, 4, 24, and 48 hours and 7 days after first randomized study treatment.
A poor response of the platelets to drug, called High Residual Platelet Reactivity (HRPR), has been incriminated to account for a recurrence of ischemic events"|2, 4, 24, 48 hours, 7 days after first randomized dose|Primary population||percentage of subjects|||Number
679132|NCT01587651|Secondary|PRU Percent Inhibition (Calculated)|"Analysis of Mean Calculated Percent Inhibition by time point
Calculated percent inhibition at time point t is defined as: 100 × (baseline PRU – PRUt)/baseline PRU where baseline PRU is the VerifyNow PRU value at pre-run-in baseline and PRUt is the VerifyNow PRU value at time t."|2, 4, 24, 48 hours, 7 days after first randomized dose|Primary population||Percent Inhibition||Standard Error|Least Squares Mean
679133|NCT01587651|Secondary|PRU Percent Inhibition (Device-reported)|"PRU VerifyNow P2Y12 assay device-reported percent inhibition 2, 4, 24, and 48 hours, and 7 days after first randomized study treatment
VerifyNow P2Y12 assay, developed by Accumetrics, Inc. (San Diego, CA, USA), has been approved by the FDA to assess clopidogrel response using whole blood in a point-of-care testing fashion. The percent inhibition reported by VerifyNow device represents the percentage inhibition relative to maximal P2Y12-independent platelet aggregation achieved with the same sample in the presence of the iso-thrombin receptor activating peptide."|2, 4, 24, 48 hours, 7 days after first randomized dose|Primary population||percent inhibition||Standard Error|Least Squares Mean
679134|NCT01587651|Secondary|Platelet Reactivity Index|"Platelet Reactivity Index (PRI) by the Vasodilator-Stimulated Phosphoprotein(VASP) assay 2, 4, 24, 48 hours and 7 days after first randomized study treatment.
The VASP assay is an indirect, but relatively specific measure of inhibition of P2Y12-induced platelet activation. The assay quantifies the level of phosphorylation of the intracellular protein VASP, which undergoes phosphorylation when platelet P2Y12 receptors are blocked. The level of VASP phosphorylation, expressed as the PRI, represents the percentage inhibition relative to an assay baseline/maximal P2Y12-independent platelet aggregation."|2, 4, 24, 48 hours, 7 days after first randomized dose|Primary Population||percentage PRI||Standard Error|Least Squares Mean
679135|NCT01587651|Secondary|P2Y12 Reaction Units|P2Y12 Reaction Units (PRU) measured by VerifyNow P2Y12 assay measured at 2, 4, 24, 48 hours after first randomized study treatment|2, 4, 24, 48 hours after first randomized dose|Primary Population||PRU||Standard Error|Least Squares Mean
679136|NCT01587651|Primary|P2Y12 Reaction Units|P2Y12 Reaction Units (PRU) measured by VerifyNow P2Y12 assay VerifyNow P2Y12 assay, developed by Accumetrics, Inc. (San Diego, CA, USA), has been approved by the FDA to assess clopidogrel response using whole blood in a point-of-care testing fashion. Platelet aggregation with this system is defined by PRU, with a higher PRU indicative of greater platelet aggregation, and a lower PRU indicative of inhibition.|7 days after first randomized dose|Primary Population includes all subjects who received at least 1 dose of randomized study drug and have valid PRU data at both randomization visit pre-dosing and end-of-treatment visit. A subject is considered to have valid PRU data for primary PD analyses if he/she does not have certain protocol deviations listed in Statistical Analysis Plan.||PRU (P2Y12 Reaction Units)||Standard Error|Least Squares Mean
679137|NCT01587118|Secondary|Change From Baseline in Brief Psychiatric Rating Scale (BPRS)|BPRS is the clinician rating of psychiatric symptoms; higher score indicates higher severity; 18-items scored 1-7; highest score 126. Overall JE and Gorham DR. The Brief Psychiatric Rating Scale (BPRS): recent developments in ascertainment and scaling. Psychopharmacol Bulletin 1993; 24:97-99.|Baseline, week 4, 8, 12|Open label treatment, all participants included.Overall change in values from baseline to week 12, including weeks 4 and 8, using a simple one-way analysis of variance; because the sample size was small, p-values for the paired t-test and one-way results were recalculated using the signed rank test and Kruskal Wallis procedure, respectively||units on a scale||Standard Deviation|Mean
679138|NCT01587118|Primary|Change From Baseline in Clinical Administered PTSD Scale (CAPS) Total|CAPS is the clinician rating of posttraumatic stress disorder (PTSD) symptoms; higher scores indicate higher severity of PTSD; 17-item score range 0 to 136. Blake DD, Weathers FW, Nagy LM, et al. The development of a Clinician-Administered PTSD Scale. J Trauma Stress 1995; 8:75-90.|baseline, week 4, 8, and 12|Open label treatment, all participants included.Overall change in values from baseline to week 12, including weeks 4 and 8, using a simple one-way analysis of variance; because the sample size was small, p-values for the paired t-test and one-way results were recalculated using the signed rank test and Kruskal Wallis procedure, respectively||units on a scale||Standard Deviation|Mean
679139|NCT01587105|Secondary|Physician Satisfaction|Primary care provider (PCP)'s satisfaction with the care coordination program was measured on a scale of 0-100, where the higher number indicates more satisfaction. This variable was collected at baseline and 12-months but was dropped from the 18 month follow-up as previous analysis suggested it was not relevant to the stated objective.|Baseline, 12 Months, 18 months|||units on a scale||Standard Deviation|Mean
679140|NCT01587105|Primary|Hospital Days Per Child|Number of days each participant stayed in the hospital; assessed from hospital administrative discharge data|Baseline, 12-Month, 18-Month|||days||95% Confidence Interval|Mean
679141|NCT01587105|Primary|Inpatient Admissions Per Child||Baseline, 12 month, 18 month|||admissions per child||95% Confidence Interval|Mean
679142|NCT01587105|Primary|ED Visits Per Child||Baseline, 12-month, 18-month|||ED visits||95% Confidence Interval|Mean
679143|NCT01587105|Primary|Health Care Quality Ranking|For Healthcare Quality Rating, the construct is Parent Satisfaction. Parents were asked to rate the quality of the health care their child received. Overall range is 0-100. Higher values equal a better outcome or more satisfaction. Sub scales are not combined. The scale is considered continuous.|Baseline, 12-months, 18-months|||units on a scale||95% Confidence Interval|Mean
679144|NCT01587105|Primary|Cost of Care|The investigators will examine whether the children in the CCM group experience decreased annual costs of care.|Baseline, 12 month, 18 month|||US Dollars||95% Confidence Interval|Mean
679145|NCT01587079|Secondary|Change From Baseline in Mean Evening Post-dose Daily Peak Flow Readings on Day 7|Change from baseline in mean evening post-dose daily peak flow readings (12 Hours post-dose for Spiriva)|Day 7|MITT||L/min||95% Confidence Interval|Least Squares Mean
679146|NCT01587079|Secondary|Change From Baseline in Mean Evening Pre-dose Daily Peak Flow Readings on Day 7|Change from baseline in mean evening pre-dose daily peak flow readings (BID treatments only)|Day 7|MITT||L/min||95% Confidence Interval|Least Squares Mean
679160|NCT01587014|Secondary|Determine Research Subject's Baseline Temperature.|Using intermittent temperature data obtained with Prima-Temp temperature patch and wireless transmission to a receiver box and PC, researchers will compare research subject's baseline temperature with temperatures taken in the ICU in the normal course of care.|0-14 days|||data unavailable|||Number
679161|NCT01587014|Primary|Total Number of Adverse Events Experienced by Participants Between Day 0 and Day 14 After Receiving the Prima-Temp Temparature Patch|The nursing staff will complete a thermometer skin site assessment daily. If the patch is removed or dislodged prior to study day 7 and 14 data points for any reason other than temporary transfer from the floor for a medical study, the nursing staff will be asked to complete an additional comfort skin site assessment. The area evaluated by the nurse will include skin in contact with both the Covidien/Kendall Lifetrace® belt and the thermometer patch.|0-14 days|||Adverse event|||Number
679162|NCT01587001|Secondary|Bronchoalveolar Lavage (BAL) Cell Glutathione (GSH) Levels|We measured changes at baseline and at 8 weeks in BAL whole cell total GSH levels and cellular 8-OHdG before and after treatment with NAC/placebo.|8 weeks of anti-oxidant therapy|||nmol/mg protein||Standard Deviation|Mean
679163|NCT01587001|Primary|Bronchoalveolar Lavage (BAL) and Peripheral Blood Mononuclear Cells (PBMC) TNF-α Levels|Baseline peripheral blood mononuclear cells and bronchoalveolar lavage (BAL) lymphocyte percentages and lipopolysaccharide (LPS) stimulated tumor necrosis factor-α levels (pg/ml)|8 weeks of anti-oxidant therapy|||pg/ml||Standard Deviation|Mean
679164|NCT01586975|Primary|PFA1|"Platelet Function Analysis (PFA) lab results: PFA was performed using the PFA 100 device (Dade-Behring), which uses a higher sheer stress flow cytometry paradigm to measure the time in seconds to closing of an aperture. Normal is defined as <172 seconds."|3-6 months (Collected once between regulalary scheduled follow-up visit between 3-6 months)|||seconds||Standard Error|Mean
679165|NCT01586962|Secondary|Safety and Tolerability of the Syrup|Number of participants with adverse events.|1 hour|||Participants|||Number
679166|NCT01586962|Secondary|Subject Acceptability of the Syrup|"How do you like the warming sensation you have experienced for this product?
Possible responses are :
Like extremely Like very much Like moderately Like slightly Neither like nor dislike Dislike slightly Dislike moderately Dislike very much Dislike extremely"|1 hour|||Participants|||Number
679167|NCT01586962|Primary|Warming Sensation Caused by the Excipient IFF Flavor 316 282, in a Syrup Containing Paracetamol 500 mg + Pseudoephedrine 30 mg Per 30 ml Syrup|Intensity of warming sensation felt by subjects between predose to 1 minute postdose where 0 = no warming sensation and 100 = strongest possible warming sensation|1 minute|||mm||Standard Deviation|Mean
679168|NCT01586897|Primary|Medication Safety Monitoring - ACE/ARB, Thiazide|Percentage of laboratory tests (potassium for thiazides, renal/potassium for ACE/ARBs that have been measured within 4-weeks following prescription. Treatment guidelines for prescription of ACE/ARBs recommend renal/potassium testing and potassium testing for prescription of thiazides. We chose 4-weeks following the prescription to represent successful safety monitoring.|Within 4 weeks following prescription|Patients prescribed ACE/ARB, thiazide||percentage of tests within 4 weeks|||Number
679169|NCT01586897|Primary|Medication Safety Monitoring - Metformin|Percentage of renal function laboratory tests that have been measured within 4-weeks following prescription. Treatment guidelines for prescription of metformin recommend renal function testing. We chose 4- weeks following the prescription to represent successful safety monitoring.|Within 4 weeks following prescription|Patients prescribed metformin||percentage of tests within 4 weeks|||Number
679170|NCT01586897|Primary|Medication Safety Monitoring - Statins|Percentage of laboratory tests (liver function tests after a new statin prescription or a change in statin dose) that have been measured within 4 weeks following prescription. Treatment guidelines for prescription of statins recommend follow-up liver function testing. We chose 4-weeks following the prescription to represent successful safety monitoring.|Within 4 weeks following prescription|Patients prescribed statins||percentage of tests within 4 weeks|||Number
679171|NCT01586897|Primary|Primary Effectiveness Outcome - A1c|Percentage of follow-up time (from initial prescription to final laboratory result available during the 18-month study period) that a patient is at or below risk factor goal for HbA1c(HbA1c ≤ 7.0%).|1 year|Patients prescribed oral medications for diabetes control during the study period||percentage of time spent at goal||Standard Deviation|Mean
679172|NCT01586897|Primary|Primary Effectiveness Outcome - LDL|Percentage of follow-up time (from initial prescription to final laboratory result available during the 18-month study period) that a patient is at or below risk factor goal for LDL(LDL-cholesterol ≤ 130 mg/dL for patients without cardiovascular risk and ≤ 100 mg/dl for patients with cardiovascular risk).|1 year|Patients prescribed statins during the study period||percentage of time spent at goal||Standard Deviation|Mean
679173|NCT01586819|Primary|Change From Pre- to Post-treatment Scores of Chemical Peel if Botox A is Added as Pre-treatment|The primary objective of this study is to determine if there is a significant difference between the change from pre- to post-treatment scores on the facial wrinkle severity scale between the chemical peel control group and the chemical peel plus Botox A treatment group. The primary dependent variable is the four-point Facial Wrinkle Severity Scale (FWSS): Grade 0 = no wrinkles; Grade 1 = mild wrinkles; Grade 2 = moderate wrinkles; and Grade 3 = severe wrinkles.|Baseline and 12 weeks|Twenty-six female subjects ages 30 to 75 years old were enrolled in this study.||Units on a wrinkle severity scale||Inter-Quartile Range|Median
679174|NCT01586819|Primary|Posttreament Results of Chemical Peel if Botox A is Added as Pre-treatment|The primary objective of this study is to determine if pre-treating the orbicularis oculi muscles with botulinum toxin A improves the results of medium depth chemical peels when treating lateral canthal rhytides. The primary dependent variable is the four-point Facial Wrinkle Severity Scale (FWSS): Grade 0 = no wrinkles; Grade 1 = mild wrinkles; Grade 2 = moderate wrinkles; and Grade 3 = severe wrinkles.|Baseline and 12 weeks|Twenty-six female subjects ages 30 to 75 years old were enrolled in this study.||Units on a wrinkle severity scale||Inter-Quartile Range|Median
679175|NCT01586806|Secondary|Opioid-Related Side Effects (Drowsiness)|Data collector will administer the Opioid-Related Distress Scale (OR-SDS) to determine if patients experience any opioid-related side effects (i.e. drowsiness). The OR-SDS score is on a scale of 0 to 4, with a higher number representing more severe symptoms.|Up to 2 days following surgery|||units on a scale||Inter-Quartile Range|Median
679176|NCT01586806|Secondary|Postoperative Morphine Consumption|Data collector will record how many opioids (i.e. Percocet, Vicodin) the patient has used since discharge.|Up to 2 days following surgery|||milligrams||Inter-Quartile Range|Median
679178|NCT01586806|Secondary|NRS (Numerical Rating Scale) Pain Scores|Patients will be asked to rate, on a scale of 0-10, their pain while at rest. 0 indicates no pain, and 10 indicates the worst pain imaginable.|Postoperative day 1|||units on a scale||Inter-Quartile Range|Median
679179|NCT01586806|Primary|Patient-perceived Duration of Analgesia|After discharge, patients will be called and given instructions to help determine length of time of analgesia in the saphenous nerve distribution.|Up to 2 days following surgery|||hours||95% Confidence Interval|Median
679180|NCT01586364|Primary|Change From Baseline in Testosterone Levels at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed.||ng/dL||Standard Deviation|Mean
679181|NCT01586364|Primary|Change From Baseline in SHBG Levels at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed.||nmol/L||Standard Deviation|Mean
679182|NCT01586364|Primary|Change From Baseline in FSH and LH Levels at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed.||IU/L||Standard Deviation|Mean
679183|NCT01586364|Primary|Change From Baseline in E2 Levels at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed.||pg/mL||Standard Deviation|Mean
679184|NCT01586364|Primary|Change From Baseline in Testosterone Levels at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed.||ng/dL||Standard Deviation|Mean
679185|NCT01586364|Primary|Change From Baseline in Sex Hormone Binding Globulin (SHBG) Levels at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed.||nmol/L||Standard Deviation|Mean
679186|NCT01586364|Primary|Change From Baseline in Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) Levels at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed.||IU/L||Standard Deviation|Mean
679187|NCT01586364|Primary|Change From Baseline in Estradiol (E2) Levels at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed.||pg/mL||Standard Deviation|Mean
679188|NCT01586364|Primary|Change From Baseline in Specific Gravity of Urine at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 195 out of 301 subjects were analyzed.||units||Standard Deviation|Mean
679189|NCT01586364|Primary|Change From Baseline in pH of Urine at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 195 out of 301 subjects were analyzed.||pH||Standard Deviation|Mean
679190|NCT01586364|Primary|Change From Baseline in Specific Gravity of Urine at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 239 out of 301 subjects were analyzed.||units||Standard Deviation|Mean
679191|NCT01586364|Primary|Change From Baseline in pH of Urine at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 239 out of 301 subjects were analyzed.||pH||Standard Deviation|Mean
679192|NCT01586364|Primary|Change From Baseline in Bilirubin, Creatinine, Glucose, Uric Acid and BUN Levels at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 197 out of 301 subjects were analyzed.||mg/dL||Standard Deviation|Mean
679193|NCT01586364|Primary|Change From Baseline in ALT, AST and CK Levels at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 197 out of 301 subjects were analyzed.||U/L||Standard Deviation|Mean
679194|NCT01586364|Primary|Change From Baseline in Albumin and Total Protein Levels at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 197 out of 301 subjects were analyzed.||g/dL||Standard Deviation|Mean
679195|NCT01586364|Primary|Change From Baseline in Bilirubin, Creatinine, Glucose, Uric Acid and Blood Urea Nitrogen (BUN) Levels at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed.||mg/dL||Standard Deviation|Mean
679196|NCT01586364|Primary|Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase (CK) Levels at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed.||U/L||Standard Deviation|Mean
679197|NCT01586364|Primary|Change From Baseline in Albumin and Total Protein Levels at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed.||g/dL||Standard Deviation|Mean
679198|NCT01586364|Primary|Change From Baseline in MCV and MPV at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed.||fL||Standard Deviation|Mean
679199|NCT01586364|Primary|Change From Baseline in Hematocrit and RBC Distribution Width at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed.||percent change||Standard Deviation|Mean
679200|NCT01586364|Primary|Change From Baseline in Hemoglobin Levels at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed.||g/dL||Standard Deviation|Mean
679201|NCT01586364|Primary|Change From Baseline in Erythrocyte Levels at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed.||(x10(12)/L)||Standard Deviation|Mean
679202|NCT01586364|Primary|Change From Baseline in Leukocyte, Lymphocyte, Monocyte and Platelet Count Levels at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed.||(x10(9)/L)||Standard Deviation|Mean
679203|NCT01586364|Primary|Change From Baseline in Mean Corpuscular Volume (MCV) and Mean Platelet Volume (MPV) at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 240 out of 301 subjects were analyzed.||fL||Standard Deviation|Mean
679204|NCT01586364|Primary|Change From Baseline in Hematocrit and Red Blood Cell (RBC) Distribution Width at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 240 out of 301 subjects were analyzed.||percent change||Standard Deviation|Mean
679205|NCT01586364|Primary|Change From Baseline in Hemoglobin Levels at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 240 out of 301 subjects were analyzed.||g/dL||Standard Deviation|Mean
679206|NCT01586364|Primary|Change From Baseline in Erythrocyte Levels at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 240 out of 301 subjects were analyzed.||(x10(12)/L)||Standard Deviation|Mean
679207|NCT01586364|Primary|Change From Baseline in Leukocyte, Lymphocyte, Monocyte and Platelet Count Levels at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 240 out of 301 subjects were analyzed.||(x10(9)/L)||Standard Deviation|Mean
679208|NCT01586364|Primary|Change From Baseline in Fibrinogen (Plasma) Levels at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 194 out of 301 subjects were analyzed.||mg/dL||Standard Deviation|Mean
679209|NCT01586364|Primary|Change From Baseline in Activated Partial Thromboplastin Time (Plasma) at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 194 out of 301 subjects were analyzed.||s||Standard Deviation|Mean
679210|NCT01586364|Primary|Change From Baseline in Coagulation Parameters (Antithrombin Antigen, Protein C Antigen, Protein S Antigen) at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 194 out of 301 subjects were analyzed.||percent change||Standard Deviation|Mean
679211|NCT01586364|Primary|Change From Baseline in Fibrinogen (Plasma) Levels at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 242 out of 301 subjects were analyzed.||mg/dL||Standard Deviation|Mean
679212|NCT01586364|Primary|Change From Baseline in Activated Partial Thromboplastin Time (Plasma) at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 242 out of 301 subjects were analyzed.||s||Standard Deviation|Mean
679213|NCT01586364|Primary|Change From Baseline in Coagulation Parameters (Antithrombin Antigen, Protein C Antigen, Protein S Antigen) at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 242 out of 301 subjects were analyzed.||percent change||Standard Deviation|Mean
679214|NCT01586364|Primary|Assessment of Breast Palpation at Visit 3|Breast palpation was used to assess breast abnormalities.|Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 199 out of 301 subjects were analyzed.||Participants|||Number
679215|NCT01586364|Primary|Assessment of Breast Palpation at Visit 2|Breast palpation was used to assess breast abnormalities.|Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed.||Participants|||Number
679216|NCT01586364|Primary|Assessment of Cervical Pap Smear Samples (if Cervix is Intact)|Cervical Pap smear samples are used to evaluate: atypical squamous cells of undetermined significance (ASC-US), squamous intraepithelial lesions (SILs), intraepithelial lesions or malignancy, and reactive endocervical cells and/or metaplastic cells.|Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 16 out of 301 subjects were analyzed.||Participants|||Number
679217|NCT01586364|Primary|Change From Baseline in Visual Evaluation of Vagina at Visit 3|Each of the categories in the table was assessed on a 4-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe)|Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 198 out of 301 subjects were analyzed.||units on a scale||Standard Deviation|Mean
679218|NCT01586364|Primary|Change From Baseline in Visual Evaluation of Vagina at Visit 2|Each of the categories in the table was assessed on a 4-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe)|Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed.||units on a scale||Standard Deviation|Mean
679219|NCT01586364|Primary|Change From Baseline in BMI at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 199 out of 301 subjects were analyzed.||kg/m^2||Standard Deviation|Mean
679220|NCT01586364|Primary|Change From Baseline in Weight at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 199 out of 301 subjects were analyzed.||kg||Standard Deviation|Mean
679221|NCT01586364|Primary|Change From Baseline in Pulse Rate at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 199 out of 301 subjects were analyzed.||bpm||Standard Deviation|Mean
679222|NCT01586364|Primary|Change From Baseline in Blood Pressure at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 199 out of 301 subjects were analyzed.||mmHg||Standard Deviation|Mean
679223|NCT01586364|Primary|Change From Baseline in Body Mass Index (BMI) at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 244 out of 301 subjects were analyzed.||kg/m^2||Standard Deviation|Mean
679224|NCT01586364|Primary|Change From Baseline in Weight at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 244 out of 301 subjects were analyzed.||kg||Standard Deviation|Mean
679225|NCT01586364|Primary|Change From Baseline in Pulse Rate at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 244 out of 301 subjects were analyzed.||bpm||Standard Deviation|Mean
679226|NCT01586364|Primary|Change From Baseline in Blood Pressure at Visit 2|Systolic blood pressure (SBP), diastolic blood pressure (DBP)|Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 244 out of 301 subjects were analyzed.||mmHg||Standard Deviation|Mean
679227|NCT01586364|Primary|Change From Baseline in Serum Lipid Levels at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, 195 out of 301 subjects were analyzed.||percent change||Standard Deviation|Mean
679228|NCT01586364|Primary|Change From Baseline in Serum Lipid Levels at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, 241 out of 301 subjects were analyzed.||percent change||Standard Deviation|Mean
679229|NCT01586364|Primary|Incidence of Adverse Events (AEs)||Week 13 (Phone Contact) to Week 56 (Visit 4)|||Participants|||Number
679230|NCT01586338|Secondary|Percentage of Participants With Change in Concomitant Medication of Osteoarthritis Therapy at Week 26|Participants were asked about their perception regarding any additional Osteoarthritis medications or treatments or any changes in regimen or dosages compared to their baseline (Day 1) state. Any change in the therapy (less use of other therapies, more use of other therapies and no change in use of other therapies) during the study was reported.|Baseline up to Week 26|FAS population.||percentage participants|||Number
679231|NCT01586338|Secondary|Clinical Observer Global Assessment (COGA) Score|COGA (assessment of target knee osteoarthritis condition) was measured using the 5 point Likert scale (0=very well, 1=well, 2=fair, 3=poor, 4=very poor) by the physician to rate participant’s osteoarthritis condition. Percentage of participants with different categories of COGA score at baseline,Week 8, 12 and 26 are reported.|Baseline, Week 8, 12 and 26 (missing data imputed by LOCF)|FAS population.||percentage of participants|||Number
679232|NCT01586338|Secondary|Patient Global Assessment (PTGA) Score|PTGA (self-assessment of target knee osteoarthritis condition) was measured using the 5 point Likert scale (0=very well, 1=well, 2=fair, 3=poor, 4=very poor) by participants to rate the osteoarthritis condition. Percentage of participants with different categories of PTGA score at baseline, Week 8, 12 and 26 are reported.|Baseline, Week 8, 12 and 26 (missing data imputed by LOCF)|FAS population.||percentage of participants|||Number
679233|NCT01586338|Secondary|Change From Baseline in WOMAC A, B and C Score at Weeks 8, 12 and 26|WOMAC is health status measure questionnaire of twenty-four questions comprising 3 subscales (pain, stiffness and physical function). Each question was measured on a scale of 0-100 mm where lower score represents lower pain (better condition) and higher score represents higher pain. WOMAC A (measure of pain during walking on a flat surface) was sum of first five items with total score ranging from 0-500 mm, Lower score represents lower pain and higher score represents higher pain. WOMAC B (Stiffness) is the sum of the sixth and seventh item, it is in the range of 0-200 mm. WOMAC C (function) is the sum of the eighth to twenty-forth item, the score is in the range of 0-1700 mm.|Baseline, Week 8, 12 and 26 (missing data imputed by LOCF)|FAS population.||mm||Standard Deviation|Mean
679234|NCT01586338|Secondary|Change From Baseline in WOMAC A1 Subscore (Walking Pain) at Week 8 and 12|WOMAC is health status measure questionnaire of twenty-four questions comprising 3 subscales (pain, stiffness and physical function). WOMAC A1 (walking pain) was measured on a scale of 0-100 mm, where lower score represents lower pain and higher score represents higher pain.|Baseline, Week 8 and Week 12 (missing data imputed by LOCF)|FAS population.||mm||Standard Deviation|Mean
679235|NCT01586338|Primary|Overview of Adverse Events (AE)|"An AE could be any unfavorable and unintended symptom, sign, disease or condition, or test abnormality whether or not considered related to the investigational product. A serious adverse event (SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs (TEAE): AEs that developed/worsened during the ‘on treatment period’ (from first dose of study drug until the end of study period). Category AE included participant with both serious and non-serious AE."|Up to Week 26|Safety Set included all participants who received at least one injection of Synvisc.||percentage of participants|||Number
679236|NCT01586338|Primary|Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 Subscore (Walking Pain) at Week 26|WOMAC is health status measure questionnaire of twenty-four questions comprising 3 subscales (pain, stiffness and physical function). WOMAC A1 (walking pain) was measured on a scale of 0-100 mm, where lower score represents lower pain and higher score represents higher pain.|Baseline, Week 26 (missing data imputed by Last Observation Carried Forward [LOCF])|Full Analysis Set (FAS) included all participants who received at least one injection of Synvisc®. 5 participants were excluded from total enrolled (3 participant due to informed consent filled by family, and 2 participant due to no efficacy data after treatment).||mm||Standard Deviation|Mean
679237|NCT01586312|Secondary|Evolution of Cartilage Degeneration by T2 Relaxation Measurements in MRI (Cartigram)|"Magnetic Resonance imaging measurements of T2 relaxation (Cartigram) performed at 0, 6 and 12 months to quantify articular cartilage degeneration. The values (in milliseconds) are T1/2 for decay of the T2 MRI signals. Normal values are below 50 ms; values above 50 ms correspond to inflamed cartilage.
Mean (SD) are expressed as the number of values (of a total of 88 measurements) that are between 50 and 90 ms. A value =<4.4 is considered normal (can be attained by chance). Values above 4.4 are considered pathological. The worst possible is 88."|up to one year|The efficacy endpoint analysis will be based on all patients who have not committed major protocol violations, and have at least one assessment of efficacy of the end graft. 3 patients of the allogenic MSC treatment group were excluded from this analysis because of incomplete measurements.||number of values (range 0-88)||Standard Deviation|Mean
679249|NCT01585987|Secondary|Percentage of Participants With Immune-Related Best Overall Response (irBOR)|IrBOR rate was defined as the number of participants whose Immune-related Best Overall Response (irBOR) criteria was Immune-related Complete Response (irCR) or Immune-related Partial Response (irPR), divided by the total number of participants. The immune-related sum of products of diameters (irSPD) incorporates - in addition to the index lesions - measurable new lesions that may have developed on-study, providing an assessment that includes both index and new lesions. irCR=Complete disappearance of all tumor lesions (both index and non-index lesions with no new measurable/unmeasurable lesions). irPR=A 50% or greater decrease, relative to baseline of the irSPD, (based on irSPD of all index lesions and any measurable new lesions).|Randomization up to 91 irPFS events (Approximately 19 months)|All participants randomized to a treatment group were summarized.||percentage of participants|||Number
679238|NCT01586312|Secondary|Pain and Disability Evolution (WOMAC, Visual Analogue Scale, Lequesne Index and SF-12 Scores)|"Clinical review, questionaires for pain, disability and quality of life at 0, 3, 6 and 12 months.
WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index): Questionnaire to quantify the pain, stiffness and physical function in patients with osteoarthritis of the knee or hip.
SF-12 (Short Form 12, an abbreviated form of SF36) is a questionnaire for the detection of changes in quality of life.
The visual analogue scale (VAS) is a psychometric response scale which can be used for subjective measurements of knee pain.
LEQUESNE algofunctional index: is a composite measure of pain and disability, with specific self-report questionnaires for knee (osteoarthritis).
All the scale ranges ranges (minimum and maximum scores) are between 0 and 100%.
Values are given in differences from baseline (usually negative values). More negative values show more improvement on both scales."|up to one year|||units on a scale||Standard Deviation|Mean
679239|NCT01586312|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Adverse events reported. Clinical review and questionaires for pain, disability and quality of life at 0, 3, 6 and 12 months|Up to one year|"Efficacy evaluable patients (EEP): A patient has been considered evaluable whenever it has undergone the specified interventions (injection of hyaluronic acid or allogeneic MSC).
and
Safety population (SP): The population that includes all evaluable patients who have undergone one of the two study treatments."||participants|||Number
679240|NCT01586195|Secondary|Number of Participants With an Adverse Event (AE)|An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution.|Up to 42 months|Safety population defined as all enrolled participants who received any amount of vemurafenib on study.||participants|||Number
679241|NCT01586195|Secondary|Percentage of Participants With 12-Month Survival||Baseline to Month 12|ITT population defined as all enrolled participants who received any amount of study drug.||percentage of participants||95% Confidence Interval|Number
679242|NCT01586195|Secondary|Percentage of Participants With 6-Month Survival||Baseline to Month 6|ITT population defined as all enrolled participants who received any amount of study drug.||percentage of participants||95% Confidence Interval|Number
679243|NCT01586195|Secondary|Overall Survival (OS)|OS was defined as the time from the date of first treatment to the date of death due to any cause. OS was summarized using Kaplan-Meier method.|Date of first treatment to date of death due to any cause (up to 42 months)|ITT population defined as all enrolled participants who received any amount of study drug.||months||95% Confidence Interval|Median
679244|NCT01586195|Secondary|Progression-free Survival (PFS)|PFS was assessed by the investigators according to RECIST v1.1 and defined as the time interval between the date of the first treatment dose and the date of disease progression or death due to any cause, whichever occurred first. PD was defined as a 20% increase in the sum of the longest diameter of target lesions or the appearance of new lesions and increase of at least 5 mm in the sum of diameters of target lesions. PFS was summarized using Kaplan-Meier method.|From start of treatment up to first documentation of disease progression or death (up to 42 months)|ITT population defined as all enrolled participants who received any amount of study drug.||months||Full Range|Median
679245|NCT01586195|Secondary|Duration of Response|In participants with a confirmed CR or PR, duration of response was defined as the time interval between the date of the earliest qualifying response and the date of progressive disease (PD) or death due to any cause. CR was defined as complete disappearance of all target lesions and non-target disease. PR was defined as a >/=30% decrease under baseline of the sum of diameters of all target lesions. PD was defined as a 20% increase in the sum of the longest diameter of target lesions or the appearance of new lesions and increase of at least 5 mm in the sum of diameters of target lesions. Duration of response was summarized using Kaplan-Meier method.|From date of earliest qualifying response up to date of disease progression or death (up to 42 months)|ITT population defined as all enrolled participants who received any amount of study drug. Participants with a confirmed CR or PR were analyzed.||months||Full Range|Median
679246|NCT01586195|Secondary|Time to BORR|In participants with a confirmed CR or PR, time to BORR was defined as the interval between the date of first treatment and the date of first documentation of confirmed CR or PR (whichever occurred first). BORR was assessed by the investigators according to RECIST v1.1. CR was defined as complete disappearance of all target lesions and non-target disease. PR was defined as a >/=30% decrease under baseline of the sum of diameters of all target lesions. Participants without confirmed CR or PR were censored at the date of last tumor assessment. The time to response was summarized using univariate statistics.|From start of treatment up to first documentation of confirmed CR or PR (up to 42 months)|ITT population defined as all enrolled participants who received any amount of study drug. Participants with a confirmed CR or PR were analyzed.||months||Full Range|Median
679247|NCT01586195|Primary|Best Objective Response Rate (BORR)|BORR was assessed by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. BORR was defined as the number of participants whose best overall response was a complete response (CR) or partial response (PR). CR was defined as complete disappearance of all target lesions and non-target disease. PR was defined as a >/=30% decrease under baseline of the sum of diameters of all target lesions. BORR was summarized along with the associated exact 95% confidence interval (CI) using the method of Clopper–Pearson.|Up to 42 months|ITT population defined as all enrolled participants who received any amount of study drug.||percentage of participants||95% Confidence Interval|Number
679248|NCT01586026|Primary|The Rate of Adverse Events in Group A (1-28 Day Flushing Interval) Versus Extended Accession Intervals in Group B (29-56 Day Flushing Interval), and Group C (57+ Days).|Subjects’ maintenance flush intervals were collected by calculating the number of days since a previous flush. A total of 1,035 maintenance flush intervals were recorded at all sites. The numbers of flushing intervals available for analysis are 1,035 representing 49,696 patient days were recorded in 171 subjects.|100 days|||adverse events|||Number
679250|NCT01585987|Secondary|Overall Survival (OS) at Study Completion|OS was defined as the time from the date of randomization until the date of death. For those participants who have not died, OS was censored on the last date the participant was known to be alive.|Randomization up to end of study, April 2015 (Approximately 28 months)|All participants randomized to a treatment group and who received at least one dose of active drug were summarized.||Months||95% Confidence Interval|Median
685593|NCT01499810|Secondary|Change in Mean 24-h Systolic BP||from baseline to 12 months|Number of participants assessed at 12 months minus 1 participant with unsatisfactory ambulatory blood pressure monitoring (ABPM) record||mmHg||Standard Deviation|Mean
679251|NCT01585987|Secondary|Overall Survival (OS) at Primary Endpoint|OS was defined as the time from the date of randomization until the date of death. For those participants who have not died, OS was censored on the last date the participant was known to be alive.|Randomization up to 91 irPFS events (Approximately 19 months)|All participants randomized to a treatment group and who received at least one dose of active drug were summarized.||Months||95% Confidence Interval|Median
679252|NCT01585987|Secondary|Progression Free Survival (PFS) Per Modified World Health Organization (mWHO) Criteria|PFS per mWHO was defined as the time between the randomization date and the time of disease progression per mWHO criteria or death, whichever occurred first and was measured in months. mWHO criteria: New lesions always mean progression; Changes in non-measurable lesions contribute in the definitions of Complete Response (CR), Partial Response (PR), Stable Disease (SD) and Progressive Disease (PD).|Randomization up to 91 irPFS events (Approximately 19 months )|All participants randomized to a treatment group were summarized.||Months||95% Confidence Interval|Median
679253|NCT01585987|Primary|Immune-related Progression Free Survival (irPFS) as Per Assessment of a Blinded Independent Review Committee (IRC) According to Immune Related Response Criteria (irRC) Guidelines|irPFS is defined as the time between the randomization date and the time of disease progression per irRC or death, whichever occurs first. irRC criteria=Measurable new lesions: incorporated into the tumor burden (eg, added to the index lesions); do not define progression unless the total measurable tumor burden increases by the required amount (25%). New non-measurable lesions: not considered progression if the total measurable tumor burden is stable or shrinking. irPFS was measured in months.|Randomization up to 91 irPFS events (Approximately 19 months )|All participants who were randomized were summarized.||Months||95% Confidence Interval|Median
679254|NCT01585961|Secondary|Change in Atrial Fibrillation Effect on Quality of Life (AFEQT) Total Score|Change is calculated as 12 month overall AFEQT score minus score at screening. An overall AFEQT score ranges from 0 to 100. A score of 0 corresponds to complete disability (or responding “extremely” limited, difficult or bothersome to all questions answered), while a score of 100 corresponds to no disability (or responding “not at all” limited, difficult or bothersome to all questions answered). Therefore a positive change in score corresponds to improvement in AF symptoms.|Screening to 12 Month Visit|Subset of Safety Population with non-missing AFEQT data at 12 months.||units on a scale||Standard Deviation|Mean
679255|NCT01585961|Secondary|Number of Patients With Outpatient Emergency Visits Related to Atrial Fibrillation||12 Month Visit|Population with Utilization Data||participants|||Number
679256|NCT01585961|Secondary|Number of Patients With Inpatient Hospital Visit(s) Related to Atrial Fibrillation||12 Month Visit|Population with Utilization Data||participants|||Number
679257|NCT01585961|Secondary|Number of Subjects With Lost Work Days, Related to AF, at 12 Month Visit||12 Month Visit|Subset of Safety Population with non-missing endpoint data.||participants|||Number
679258|NCT01585961|Secondary|Post-procedure AF Symptoms|Symptoms attributed to paroxysmal atrial fibrillation reported at 12 month visit|12 Month Visit|Subset of Safety Population with non-missing endpoint data.||participants|||Number
679259|NCT01585961|Secondary|Number of Patients With Repeat Ablations||1 year|Safety Population||participants|||Number
679260|NCT01585961|Secondary|Fluid Volume Delivered Via Ablation Catheter||Day 0 (procedure)|Subset of Safety Population with non-missing endpoint data.||mL||Standard Deviation|Mean
679261|NCT01585961|Secondary|Total Radiofrequency (RF) Time|Total RF time is defined as the total time that RF energy is delivered during the procedure.|Day 0 (procedure)|Subset of Safety Population with non-missing endpoint data.||minutes||Standard Deviation|Mean
679262|NCT01585961|Secondary|Mean Number of Radiofrequency (RF) Applications|RF applications is defined as the number of times RF energy is delivered during the procedure.|Day 0 (procedure)|Subset of Safety Population with non-missing endpoint data.||number of applications||Standard Deviation|Mean
679263|NCT01585961|Primary|Acute Procedural Success|Confirmation of entrance and/or exit block across all targeted pulmonary veins.|Day 0 (procedure)|Safety population||participants|||Number
679264|NCT01585961|Primary|Total Procedure Time||Day 0 (procedure)|Subset of Safety Population with non-missing endpoint data.||minutes||Standard Deviation|Mean
679265|NCT01585961|Primary|Total Fluoroscopy Time|The fluoroscopy time will be measured for each phase (access, mapping, ablation, and validation) of the procedure and summed to derive the total time.|Day 0 (procedure)|Subset of Safety Population with non-missing endpoint data.||minutes||Standard Deviation|Mean
679266|NCT01585779|Secondary|Change in New York Heart Association (NYHA) Classification .|Assess the effect of TV repair with the study ring on the tricuspid valve functional status by analysis of the New York Heart Association (NYHA) classification from pre-implant through 12 months post-implant.|Preimplant through 12 months|||participants|||Number
679267|NCT01585779|Secondary|Change in New York Heart Association (NYHA) Classification|Assess the effect of TV repair with the study ring on the tricuspid valve functional status by analysis of the New York Heart Association (NYHA) classification from pre-implant through 12 months post-implant.|Preimplant through 6 months|||participants|||Number
679268|NCT01585779|Secondary|Change in New York Heart Association (NYHA) Classification|Assess the effect of TV repair with the study ring on the tricuspid valve functional status by analysis of the New York Heart Association (NYHA) classification from pre-implant through 12 months post-implant.|Preimplant through Discharge|||participants|||Number
679269|NCT01585779|Secondary|Demographic Data|Characterize the patient population for which an annuloplasty ring is chosen to repair TV insufficiency and assess the effect of TV repair with the study ring on the tricuspid valve functional status|Baseline|||participants|||Number
679270|NCT01585779|Secondary|Change in the RV Fractional Area|The secondary objective is the evaluation of effect of TV repair with the study ring on RV fractional area. Change in the RV fractional area preimplant through 12 months post-implant.|Preimplant through 12 Months|||percent||Inter-Quartile Range|Median
679271|NCT01585779|Secondary|Change in the RV Fractional Area|The secondary objective is the evaluation of effect of TV repair with the study ring on RV fractional area. Change in the RV fractional area preimplant through 12 months post-implant.|Preimplant through 6 Months|||percent||Inter-Quartile Range|Median
679272|NCT01585779|Secondary|Change in the RV Fractional Area|The secondary objective is the evaluation of effect of TV repair with the study ring on RV fractional area. Change in the RV fractional area preimplant through 12 months post-implant.|Preimplant through Discharge|||percent||Inter-Quartile Range|Median
679273|NCT01585779|Secondary|Change in the Tricuspid Annular (Basal) Diameter|The secondary objective is the evaluation of effect of TV repair with the study ring on Tricuspid annular (basal) diameter. Change in the tricuspid annular (basal) diameter from preimplant through 12 months post-implant|Preimplant through 12 Months|||mm||Inter-Quartile Range|Median
679274|NCT01585779|Secondary|Change in the Tricuspid Annular (Basal) Diameter|The secondary objective is the evaluation of effect of TV repair with the study ring on Tricuspid annular (basal) diameter. Change in the tricuspid annular (basal) diameter from preimplant through 12 months post-implant|Preimplant through 6 Months|||mm||Inter-Quartile Range|Median
679275|NCT01585779|Secondary|Change in the Tricuspid Annular (Basal) Diameter|The secondary objective is the evaluation of effect of TV repair with the study ring on Tricuspid annular (basal) diameter. Change in the tricuspid annular (basal) diameter from preimplant through 12 months post-implant|Preimplant through Discharge|||mm||Inter-Quartile Range|Median
679276|NCT01585779|Secondary|Change in the Right Ventricle (RV) Diastolic Area|The secondary objective is the evaluation of effect of TV repair with the study ring on Right ventricle (RV) diastolic area at end diastole. Change in the Right ventricle (RV) diastolic area from preimplant through 12 months post-implant|Preimplant through 12 Months|||mm^2||Inter-Quartile Range|Median
679277|NCT01585779|Secondary|Change in the Right Ventricle (RV) Diastolic Area|The secondary objective is the evaluation of effect of TV repair with the study ring on Right ventricle (RV) diastolic area at end diastole. Change in the Right ventricle (RV) diastolic area from preimplant through 12 months post-implant.|Preimplant through 6 Months|||mm^2||Inter-Quartile Range|Median
679278|NCT01585779|Secondary|Change in the Right Ventricle (RV) Diastolic Area|The secondary objective is the evaluation of effect of TV repair with the study ring on Right ventricle (RV) diastolic area at end diastole. Change in the Right ventricle (RV) diastolic area from preimplant through 12 months post-implant.|Preimplant through Discharge|||mm^2||Inter-Quartile Range|Median
679279|NCT01585779|Primary|Change in the Degree of TV Leaflet Tethering Height|The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the TV leaflet tethering height. Change in the degree of TV leaflet tethering height from pre-implant through 12 months post-implant|Preimplant through 12 Months|||mm||Inter-Quartile Range|Median
679280|NCT01585779|Primary|Change in the Degree of TV Leaflet Tethering Height|The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the TV leaflet tethering height. Change in the degree of TV leaflet tethering height from pre-implant through 12 months post-implant.|Preimplant through 6 Months|||mm||Inter-Quartile Range|Median
679281|NCT01585779|Primary|Change in the Degree of TV Leaflet Tethering Height|The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the TV leaflet tethering height. Change in the degree of TV leaflet tethering height from pre-implant through 12 months post-implant.|Preimplant through Discharge|||mm||Inter-Quartile Range|Median
679282|NCT01585779|Primary|Change in the Degree of TV Leaflet Coaptation Length|The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the TV leaflet coaptation length. Change in the degree of TV leaflet coaptation length from preimplant through 12 months postimplant.|Preimplant through 12 Months|||mm||Inter-Quartile Range|Median
679283|NCT01585779|Primary|Change in the Degree of TV Leaflet Coaptation Length|The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the TV leaflet coaptation length. Change in the degree of TV leaflet coaptation length from preimplant through 12 months postimplant.|Preimplant through 6 Months|||mm||Inter-Quartile Range|Median
679284|NCT01585779|Primary|Change in the Degree of TV Leaflet Coaptation Length|The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the TV leaflet coaptation length. Change in the degree of TV leaflet coaptation length from preimplant through 12 months postimplant.|Preimplant through Discharge|||mm||Inter-Quartile Range|Median
679285|NCT01585779|Primary|The Mean Gradient Across the Tricuspid Valve|The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the mean gradient across the tricuspid valve. The mean gradient across the tricuspid valve measured at discharge, 6 months, and 12 months post-implant|12 months|||mmHg||Inter-Quartile Range|Median
679286|NCT01585779|Primary|The Mean Gradient Across the Tricuspid Valve|The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the mean gradient across the tricuspid valve. The mean gradient across the tricuspid valve measured at discharge, 6 months, and 12 months post-implant|6 months|||mmHg||Inter-Quartile Range|Median
679287|NCT01585779|Primary|The Mean Gradient Across the Tricuspid Valve|The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the mean gradient across the tricuspid valve. The mean gradient across the tricuspid valve measured at discharge, 6 months, and 12 months post-implant|Discharge|||mmHg||Inter-Quartile Range|Median
679288|NCT01585779|Primary|Change in the Degree of Tricuspid Regurgitation|"The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment.
Degree of TV regurgitation - Change in the degree of tricuspid regurgitation from preimplant through 12 months postimplant."|Preimplant through 12 Months|||participants|||Number
679289|NCT01585779|Primary|Change in the Degree of Tricuspid Regurgitation|"The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment.
Degree of TV regurgitation - Change in the degree of tricuspid regurgitation from preimplant through 12 months postimplant."|Preimplant through 6 Months|||participants|||Number
679290|NCT01585779|Primary|Change in the Degree of Tricuspid Regurgitation|"The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment.
Degree of TV regurgitation - Change in the degree of tricuspid regurgitation from preimplant through 12 months postimplant."|Preimplant through Discharge|||participants|||Number
685594|NCT01499810|Secondary|Change in Office Diastolic BP||from baseline to 12 months|||mmHg||Standard Deviation|Mean
679291|NCT01585597|Secondary|Modified Rankin Scale 0-2|"Modified Rankin Score 0=no symptoms
no significant disability
slight disability needs help
moderate disability
moderate serve disability
severe disability 0-2 = good outcome 3-5= poor outcome"|90 days post hospitalization|||participants Modified Rankin Scal 0-2|||Number
679292|NCT01585597|Primary|Number of Participants With Reperfusion Injury \ Hemorrhagic Transformation|Asymptomatic and symptomatic Hemorrhages defined as homogenous density occupying >30% of the infarct zone with mass effect|24 Hours|||participants|||Number
679293|NCT01585584|Primary|Sustained Virologic Response (SVR) at 24 Weeks Post Treatment|Sustained Virologic Response (SVR) is evaluated 24 weeks after end of treatment and defined as undetectable plasma HCV-RNA at follow up week 24. HCV RNA is measured using Cobas TaqMan.Of the 6 subjects who completed the treatment, 3 obtained SVR at 24 weeks post treatment.|24 weeks after treatment|Patients who completed full course of treatment||participants|||Number
679294|NCT01585558|Primary|Change From Baseline in BMI||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.||kg/m^2||Standard Deviation|Mean
679295|NCT01585558|Primary|Change From Baseline in Weight||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.||kg||Standard Deviation|Mean
679296|NCT01585558|Primary|Change From Baseline in Pulse Rate||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.||bpm||Standard Deviation|Mean
679297|NCT01585558|Primary|Change From Baseline in DBP||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.||mmHg||Standard Deviation|Mean
679298|NCT01585558|Primary|Change From Baseline in SBP||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.||mmHg||Standard Deviation|Mean
679299|NCT01585558|Primary|Change From Baseline in BMI||Baseline to Week 26|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 66 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.||kg/m^2||Standard Deviation|Mean
679300|NCT01585558|Primary|Change From Baseline in Weight||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 66 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.||kg||Standard Deviation|Mean
679301|NCT01585558|Primary|Change From Baseline in Pulse Rate||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 66 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.||bpm||Standard Deviation|Mean
679302|NCT01585558|Primary|Change From Baseline in Diastolic Blood Pressure (DBP)||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 66 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.||mmHg||Standard Deviation|Mean
679303|NCT01585558|Primary|Change From Baseline in Systolic Blood Pressure (SBP)||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 66 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.||mmHg||Standard Deviation|Mean
679304|NCT01585558|Primary|Change From Baseline in Specific Gravity of Urine||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 57 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.||units||Standard Deviation|Mean
679305|NCT01585558|Primary|Change From Baseline in pH of Urine||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 57 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.||pH||Standard Deviation|Mean
679306|NCT01585558|Primary|Change From Baseline in Specific Gravtiy of Urine||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 64 subjects in the ospemifene 30 mg group, 64 out of 69 subjects in the ospemifene 60 mg group, and 41 out of 49 subjects in the placebo group were analyzed.||units||Standard Deviation|Mean
679307|NCT01585558|Primary|Change From Baseline in pH of Urine||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 64 subjects in the ospemifene 30 mg group, 64 out of 69 subjects in the ospemifene 60 mg group, and 41 out of 49 subjects in the placebo group were analyzed.||pH||Standard Deviation|Mean
679308|NCT01585558|Primary|Change From Baseline in Hematocrit Levels||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.||percent change||Standard Deviation|Mean
679309|NCT01585558|Primary|Change From Baseline in Hemoglobin Levels||Baseine to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.||g/dL||Standard Deviation|Mean
679348|NCT01585558|Primary|Mean Percent Change From Baseline in Serum Lipids||Baseline to Week 26 (Visit 5)|||percent change||Standard Deviation|Mean
679310|NCT01585558|Primary|Change From Baseline in Erythrocyte (RBC) Levels||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.||(x10(12)/L)||Standard Deviation|Mean
679311|NCT01585558|Primary|Assessment of Hematology Tests|Change from baseline|Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.||(x10(9)/L)||Standard Deviation|Mean
679312|NCT01585558|Primary|Change From Baseline in Hematocrit Levels||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 51 out of 62 subjects in the ospemifene 30 mg group, 61 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.||percent change||Standard Deviation|Mean
679313|NCT01585558|Primary|Change From Baseline in Hemogobin Levels||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 51 out of 62 subjects in the ospemifene 30 mg group, 61 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.||g/dL||Standard Deviation|Mean
679314|NCT01585558|Primary|Change From Baseline in Erythrocyte (RBC) Levels||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 51 out of 62 subjects in the ospemifene 30 mg group, 61 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.||(x10(12)/L)||Standard Deviation|Mean
679315|NCT01585558|Primary|Assessment of Hematology Tests|Change from baseline|Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 51 out of 62 subjects in the ospemifene 30 mg group, 61 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.||(x10(9)/L)||Standard Deviation|Mean
679316|NCT01585558|Primary|Assessment of Breast Palpation|Breast palpation was done by the investigator to assess abnormalities in the breast.|Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.||Participants|||Number
679317|NCT01585558|Primary|Assessment of Breast Palpation|Breast palpation was done by the investigator to assess abnormalities in the breast.|Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 65 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.||Participants|||Number
679318|NCT01585558|Primary|Change From Baseline in Thromboplastin Time||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.||s||Standard Deviation|Mean
679319|NCT01585558|Primary|Change From Baseline in Protein S Ag (Free), P Levels||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.||percent change||Standard Deviation|Mean
679320|NCT01585558|Primary|Change From Baseline in Protein C Ag, P Levels||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.||percent change||Standard Deviation|Mean
679321|NCT01585558|Primary|Change From Baseline in Fibrinogen Levels||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.||mg/dL||Standard Deviation|Mean
679322|NCT01585558|Primary|Change From Baseline in Antithrombin Antigen, P Levels||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.||percent change||Standard Deviation|Mean
679323|NCT01585558|Primary|Change From Baseline in Thromboplastin Time||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.||s||Standard Deviation|Mean
679324|NCT01585558|Primary|Change From Baseline in Protein S Ag (Free), P Levels||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.||percent change||Standard Deviation|Mean
679325|NCT01585558|Primary|Change From Baseline in Protein C Ag, P Levels||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.||percent change||Standard Deviation|Mean
679326|NCT01585558|Primary|Change From Baseline in Fibrinogen Levels||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.||mg/dL||Standard Deviation|Mean
679327|NCT01585558|Primary|Change From Baseline in Antithrombin Antigen, P Levels||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.||percent change||Standard Deviation|Mean
679328|NCT01585558|Primary|Change From Baseline in Testosterone (Free) Levels||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.||ng/dL||Standard Deviation|Mean
679329|NCT01585558|Primary|Change From Baseline in Testosterone (Total) Levels||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.||ng/dL||Standard Deviation|Mean
679330|NCT01585558|Primary|Assessment of Mammography|Mammography was done for the detection of characteristic masses and microcalcifications in the breast.|Week 52 (Visit 6)|||Participants|||Number
679331|NCT01585558|Primary|Change From Baseline in SHBG Levels||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.||nmol/L||Standard Deviation|Mean
679332|NCT01585558|Primary|Change From Baseline in FSH Levels||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.||IU/L||Standard Deviation|Mean
679333|NCT01585558|Primary|Change From Baseline in LH Levels||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.||IU/L||Standard Deviation|Mean
679334|NCT01585558|Primary|Change From Baseline in E2 Levels||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.||pg/mL||Standard Deviation|Mean
679335|NCT01585558|Primary|Change From Baseline in Testosterone (Free) Levels||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.||ng/dL||Standard Deviation|Mean
679336|NCT01585558|Primary|Change From Baseline in Testosterone (Total) Levels||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.||ng/dL||Standard Deviation|Mean
679337|NCT01585558|Primary|Change From Baseline in Sex Hormone Binding Globulin (SHBG) Levels||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.||nmol/L||Standard Deviation|Mean
679338|NCT01585558|Primary|Change From Baseline in Follicle Stimulating Hormone (FSH) Levels||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.||IU/L||Standard Deviation|Mean
679339|NCT01585558|Primary|Change From Baseline in Luteinizing Hormone (LH) Levels||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.||IU/L||Standard Deviation|Mean
679340|NCT01585558|Primary|Change From Baseline in Estradiol (E2) Levels||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.||pg/mL||Standard Deviation|Mean
679341|NCT01585558|Primary|Change From Baseline in Visual Evaluation of the Vagina|Petechiae, pallor, friability, dryness in the mucosa, and redness in the mucosa were assessed on a 4-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe).|Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.||Units on a scale||Standard Deviation|Mean
679342|NCT01585558|Primary|Change From Baseline in Visual Evaluation of the Vagina|Petechiae, pallor, friability, dryness in the mucosa, and redness in the mucosa were assessed on a 4-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe).|Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 65 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.||Units on a scale||Standard Deviation|Mean
679343|NCT01585558|Primary|Assessment of Endometrial Safety With a TVU|Mean change in endometrial thickness from baseline|Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 46 out of 62 subjects in the ospemifene 30 mg group, 52 out of 69 subjects in the ospemifene 60 mg group, and 30 out of 49 subjects in the placebo group were analyzed.||mm||Standard Deviation|Mean
679344|NCT01585558|Primary|Assessment of Endometrial Safety With a Transvaginal Ultrasound (TVU)|Mean change in endometrial thickness from baseline|Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 50 out of 62 subjects in the ospemifene 30 mg group, 60 out of 69 subjects in the ospemifene 60 mg group, and 37 out of 49 subjects in the placebo group were analyzed.||mm||Standard Deviation|Mean
679345|NCT01585558|Primary|Mean Change in Blood Chemistry Parameters||Baseline to Week 52 (Visit 6)|||U/L||Standard Deviation|Mean
679346|NCT01585558|Primary|Mean Change in Blood Chemistry Parameters||Baseline to Week 26 (Visit 5)|||U/L||Standard Deviation|Mean
679347|NCT01585558|Primary|Mean Percent Change From Baseline in Serum Lipids||Baseline to Week 52 (Visit 6)|||percent change||Standard Deviation|Mean
679349|NCT01585558|Primary|Assessment of Endometrial Biopsy|Assessments were based on Blaustein’s classification.|Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 46 out of 62 subjects in the ospemifene 30 mg group, 55 out of 69 subjects in the ospemifene 60 mg group, and 32 out of 49 subjects in the placebo group were analyzed.||Participants|||Number
679350|NCT01585558|Primary|Assessment of Cervical Pap Smear Samples|Cervical Pap smear samples were used to evaluate: atypical squamous cells of undetermined significance (ASC-US), squamous intraepithelial lesions (SILs), intraepithelial lesions or malignancy, and reactive endocervical cells and/or metaplastic cells.|Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 34 out of 49 subjects in the placebo group were analyzed.||Participants|||Number
679351|NCT01585558|Primary|Incidence of Adverse Events (AEs)||Week 20 (Phone Contact) to Week 56 (Visit 7)|||Participants|||Number
679352|NCT01585441|Secondary|Number of Participants Presenting No Change in Fluid Leakage at the Safety Visit Compared to Baseline|Changes in leakage as observed on fluorescein angiography (FA)|Final Study Visit|||participants|||Number
679353|NCT01585441|Secondary|Number of Participants Presenting No Change in Fluid Leakage at Month 3 Compared to Baseline|Changes in leakage as observed on fluorescein angiography (FA)|Month 3|||participants|||Number
679354|NCT01585441|Secondary|Number of Participants Presenting No Change in Size of Existing Plaque(s) on Indocyanine Green (ICG) Angiography at the Safety Visit Compared to Baseline||Final Study Visit|One placebo participant was not evaluated at the final safety visit, as the participant completed the study at the Month 3 visit.||participants|||Number
679355|NCT01585441|Secondary|Number of Participants Presenting No Change in Size of Existing Plaque(s) on Indocyanine Green (ICG) Angiography at Month 3 Compared to Baseline||Month 3|||participants|||Number
679356|NCT01585441|Secondary|Number of Participants Presenting No Change in Autofluorescence Patterns at the Safety Visit Compared to Baseline|Autofluorescence patterns as observed on Fundus Autofluorescence (FAF) imaging|Final Study Visit|One placebo participant was not evaluated at the final safety visit, as the participant completed the study at the Month 3 visit.||participants|||Number
679357|NCT01585441|Secondary|Number of Participants Presenting No Change in Autofluorescence Patterns at Month 3 Compared to Baseline|Autofluorescence patterns as observed on Fundus Autofluorescence (FAF) imaging|Month 3|||participants|||Number
679358|NCT01585441|Secondary|Change in Urinary Levels of Cortisol at the Safety Visit Compared to Baseline|The mean change is reported in micrograms (μg).|Final Study Visit|One finasteride participant's cortisol lab value could not be calculated due to Cortisol, Urine <1.5 ng/mL.||μg||Standard Deviation|Mean
679359|NCT01585441|Secondary|Change in Urinary Levels of Cortisol at Month 3 Compared to Baseline|The mean change is reported in micrograms (μg).|Month 3|||μg||Standard Deviation|Mean
679360|NCT01585441|Secondary|Change in Serum Testosterone Concentration at the Safety Visit Compared to Baseline|The mean change is reported in nanograms of testosterone per decaliter of serum.|Final Study Visit|||ng/dL|Participants|Standard Deviation|Mean
679361|NCT01585441|Secondary|Change in Serum Testosterone Concentration at Month 3 Compared to Baseline|The mean change is reported in nanograms of testosterone per decaliter of serum.|Month 3|||ng/dL||Standard Deviation|Mean
679362|NCT01585441|Secondary|Change in Serum Dihydrotestosterone (DHT) Concentration at the Safety Visit Compared to Baseline|The mean change is reported in picograms of DHT per milliliter of serum.|Final Study Visit|||pg/mL||Standard Deviation|Mean
679363|NCT01585441|Secondary|Change in Serum Dihydrotestosterone (DHT) Concentration at Month 3 Compared to Baseline|The mean change is reported in picograms of DHT per milliliter of serum.|Month 3|||pg/mL||Standard Deviation|Mean
679364|NCT01585441|Secondary|Change in Central Retinal Thickness in the Study Eye at the Safety Visit Compared to Baseline|Central retinal thickness was assessed by spectral-domain optical coherence tomography (SD-OCT).|Final Study Visit|||μm|Participants|Standard Deviation|Mean
679365|NCT01585441|Secondary|Change in Central Retinal Thickness in the Study Eye at Month 3 Compared to Baseline|Central retinal thickness was assessed by spectral-domain optical coherence tomography (SD-OCT).|Month 3|||μm|Participants|Standard Deviation|Mean
679366|NCT01585441|Secondary|Changes in Mean Macular Sensitivity in the Study Eye at the Safety Visit Compared to Baseline|Microperimetry was used to assess macular sensitivity.|Final Study Visit|||decibels|Participants|Standard Deviation|Mean
679367|NCT01585441|Secondary|Changes in Mean Macular Sensitivity in the Study Eye at Month 3 Compared to Baseline|Microperimetry was used to assess macular sensitivity.|Month 3|||decibels|Participants|Standard Deviation|Mean
679368|NCT01585441|Secondary|Percent Change in Subretinal Fluid Volume in the Study Eye at Month 3 Compared to Baseline|Subretinal fluid volume will be determined by manually moving the segmentation lines of the optical coherence tomography (OCT) image using the “Edit Segmentation” function of the Cirrus™ HD-OCT software. The segmentation lines will be edited to outline the inner and outer borders of the subretinal fluid pocket. This will be done manually for all the individual B-scans of each OCT image, after which the software algorithm automatically calculates the subretinal fluid volume.|Month 3|||percent change|Participants|Standard Deviation|Mean
679369|NCT01585441|Secondary|Changes in Best-corrected Visual Acuity (BCVA) in the Study Eye at the Safety Visit Compared to Baseline|"Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.
A positive change value indicates improvement of the outcome. A negative change value indicates worsening of the outcome."|Final Study Visit|||ETDRS letters|Participants|Standard Deviation|Mean
679370|NCT01585441|Secondary|Changes in Best-corrected Visual Acuity (BCVA) in the Study Eye at Month 3 Compared to Baseline|"Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.
A positive change value indicates improvement of the outcome. A negative change value indicates worsening of the outcome."|Month 3|||ETDRS letters|Participants|Standard Deviation|Mean
679371|NCT01585441|Secondary|Number of Participants Who Withdrew From the Study||Duration of the study, up to 1.5 years|||participants|||Number
679372|NCT01585441|Secondary|Number of Participants With Adverse Reactions Related to the Investigational Product|The outcome measure refers only to events that were classified as related to the investigational product.|Duration of the study, up to 1.5 years|||participants|||Number
679373|NCT01585441|Primary|Proportion of Participants With a Reduction in Subretinal Fluid Volume ≥ 50% at 3 Months Compared to Baseline|This is the primary outcome measure for publication of study results. Subretinal fluid volume will be determined by manually moving the segmentation lines of the optical coherence tomography (OCT) image using the “Edit Segmentation” function of the Cirrus™ HD-OCT software. The segmentation lines will be edited to outline the inner and outer borders of the subretinal fluid pocket. This will be done manually for all the individual B-scans of each OCT image, after which the software algorithm automatically calculates the subretinal fluid volume.|Month 3|||participants|Participants||Number
679374|NCT01585441|Primary|Proportion of Participants With an Improvement in Best-corrected Visual Acuity (BCVA) ≥ 15 Letters at 3 Months Compared to Baseline.|This is the regulatory filing primary outcome measure. Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Month 3|||participants|Participants||Number
679375|NCT01585428|Secondary|Cytokine Release by Bulk Peripheral Blood Lymphocytes (PBL) (+/- Peptide Stimulation)|Cytokine release by bulk peripheral blood lymphocytes (PBL) (+/- peptide stimulation) will be assessed by an ex vivo immunological assay. Differences of 2 to 3 fold in this assay is indicative of true biologic differences.|Prior to and 4-6 weeks after the treatment||06/2017||||
679376|NCT01585428|Secondary|Forkhead Box p3 (Foxp53) Levels|Foxp53 levels will be analyzed by semi-quantitative reverse transcription polymerase chain reaction to evaluate messenger ribonucleic acid (mRNA) on peripheral blood lymphocytes (PBL) samples.|Prior to cell infusion and at follow up time point||06/2017||||
679377|NCT01585428|Secondary|T Cell Function|Lymphocytes will be obtained by apheresis and tested to quantify T cells reactive with targets fluorescence activated cell sorting (FACS) analysis using tetramer staining. Difference of 2 to 3 fold in these assays are indicative of true biologic differences.|Prior to and 4-6 weeks after the treatment.||06/2017||||
679378|NCT01585428|Secondary|Number of Patients With Serious and Non-serious Adverse Events|Here is the number of serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0). A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. A non-serious adverse event is any untoward medical occurrence.|51 months and 18 days|||Participants|||Count of Participants
679379|NCT01585428|Primary|Number of Participants With an Objective Clinical Response|Patients must have a partial response (PR) or complete response (CR) at least 4 months after cell infusion to count towards clinical response. Clinical response is assessed by the Response Criteria in Solid Tumors (RECIST) v1.0. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Complete response is disappearance of all target lesions. Progression is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum LD.|4 months after cell infusion|||Participants|||Count of Participants
679380|NCT01585324|Secondary|Number of Participants With Thrombocytopenia Among Participants With or Without SVR||Week 12|ITT population included all enrolled participants who received at least 1 dose of study drug.||participants|||Number
679381|NCT01585324|Secondary|Number of Participants With Neutropenia Among Participants With or Without SVR||Week 12|ITT population included all enrolled participants who received at least 1 dose of study drug.||participants|||Number
679382|NCT01585324|Secondary|Number of Participants With Reduction in Ribavirin Dose Due to Drop in Hemoglobin Among Participants With or Without SVR||Week 12|ITT population included all enrolled participants who received at least 1 dose of study drug.||participants|||Number
679383|NCT01585324|Secondary|Lowest Hemoglobin Level During Treatment Among Participants With or Without SVR|The mean minimum hemoglobin value achieved during the treatment was assessed in the group of participants who achieved SVR and in the group of participants without SVR.|Week 12|ITT population included all enrolled participants who received at least 1 dose of study drug.||g/L||Standard Deviation|Mean
679384|NCT01585324|Secondary|Number of Participants With Decrease in Hemoglobin|The drop in hemoglobin level at Week 12 compared to level at baseline was assessed and categorized in pre-defined categories (up to 20, 20-40, greater than [>] 40 g/L) for the group of participants who achieved SVR and in the group of participants without SVR.|Week 12|ITT population included all enrolled participants who received at least 1 dose of study drug.||participants|||Number
679385|NCT01585324|Primary|Change From Baseline in Hemoglobin Level at Week 12 of Treatment Among Participants With or Without SVR|Change in hemoglobin level from a baseline level was assessed in the group of participants who achieved SVR and in the group of participants without SVR.|Baseline and Week 12|ITT population included all enrolled participants who received at least 1 dose of study drug.||grams per liter (g/L)||Standard Deviation|Mean
679386|NCT01585324|Primary|Percentage of Participants With Sustained Virological Response (SVR) 24 Weeks After End of Treatment|SVR was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.|24 weeks after the end of treatment (72 weeks)|ITT population included all enrolled participants who received at least 1 dose of study drug.||percentage of participants||95% Confidence Interval|Number
679387|NCT01585272|Secondary|Percentage of Patients Successfully Titrated to Rivastigmine Patch 10 cm^2|The percentage of patients successfully titrated to rivastigmine patch 10 cm2|Baseline through week 52|Safety population: All enrolled subjects who received 3 mg b.i.d Exelon capsule for more than 4 weeks and used at least one dose of Exelon patch therapy.||Percentage of participants|||Number
679738|NCT01579565|Secondary|Pupil Diameter Less Than 6 mm Anytime During Surgery|The number of subjects with pupil diameter less than 6 mm at any time during surgery summarized by treatment arm.|Intraoperative|Subjects with interpretable video images obtained during ILR procedure.||participants|||Number
679388|NCT01585272|Secondary|The Discontinuation Rate Due to the Treatment Switching From Oral Capsule to Rivastigmine Patch Treatment|The discontinuation rate due to the treatment switching from oral capsule to patch treatment. For patients who discontinue earlier due to intolerance of patch treatment, the proportion will be analyzed. Both the discontinuation rate of 5 cm2 and 10 cm^2 patch therapy will be presented.|Baseline through week 52|Of the patients treated, N=121, number of patients analyzied were those who received 5cm patch (n=114) and those who received 10cm patch (n=96)||Participants|||Number
679389|NCT01585272|Secondary|Change From Baseline in Alzheimer Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)|The changes in Alzheimer Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) of patients with Alzheimer’s disease treated with Exelon 5 cm^2 Patch at Week 28 and Exelon 10 cm^2 Patch at Week 52 versus baseline, the treatment-switching day at Week 4. ADAS-Cog has been used as the major cognitive measure of anti-dementia drugs. The total score range is 0 to 70 points, with higher scores indicating greater cognitive impairment. The assessments will be conducted at Visit, 2, 8, 11 and 17 (Week 4 (baseline), 16, 28 and 52).|Baseline, week 16, 28 and 52|ITT population: All enrolled subjects who received 3 mg b.i.d Exelon capsule orally for 4 weeks and at least one dose of Exelon patch therapy.||Score||Standard Deviation|Mean
679390|NCT01585272|Secondary|Change From Baseline in Mini-Mental Status Examination (MMSE)|The changes in Mini-Mental Status Examination (MMSE) of patients with Alzheimer’s disease treated with Exelon 5 cm^2 Patch at Week 28 and Exelon 10 cm2 Patch at Week 52 versus baseline, the treatment-switching day at Week 4. MMSE is a multi-item instrument that examines orientation, registration, attention, calculation, recall, visuospatial ability and language. The total score can range from 0 to 30, with a higher score indicating better function. A positive change score indicates improvement from baseline. The assessments will be conducted at Visit 1, 2, 8, 11 and 17 (screening, Week 4 (baseline), 16, 28 and 52).|Baselin, week 16, 28 and 52|ITT population: All enrolled subjects who received 3 mg b.i.d Exelon capsule orally for 4 weeks and at least one dose of Exelon patch therapy||Score||Standard Deviation|Mean
679391|NCT01585272|Primary|Number of Patients With Adverse Events, Serious Adverse Events, and Death|The overall rate of adverse events reported from initiation through the first 28-week treatment period|Baseline through week 28|Safety population: All enrolled subjects who received 3 mg b.i.d Exelon capsule for more than 4 weeks and used at least one dose of Exelon patch therapy.||Participants|||Number
679392|NCT01585246|Primary|Number of Participants With Dose Limiting Toxicities to Determine the Maximum Tolerated Dose|Dose limiting toxicities was defined as the Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or higher for gastrointestinal symptoms (nausea, gastritis, anorexia). The maximum tolerated dose (MTD) was established among 320mg, 640mg,or 960mg, at which less than 10% of men report less than a grade 2 of gastrointestinal symptoms.|Baseline to Week 12|Number of participants reporting adverse events at grade 2 or higher, according to the TITE-CRM algorithm||participants|||Number
679393|NCT01585246|Primary|Efficacy|Evaluate preliminary efficacy of Saw Palmetto at the MTD as compared to the placebo group with respect to Health-Related Quality of life (HRQOL) including physical functioning and symptoms. The outcomes were measured using 1) the International Prostate Symptoms Score (IPSS) and 2) the total and subscales of the Functional Assessment of Cancer Therapy-Prostate (FACT-P). The IPSS which ranges from 0-35. A lower score indicates better symptoms. The FACT-P has the following subscores and ranges: emotional well-being (0-24), functional well-being (0-28), physical well-being (0-28), social well-being (0-28), and prostate-specific concerns (0-48). The FACT-P total is comprised of the sum of the subscales and ranges from 0-156. For the FACT-P, a higher score indicates better quality of life. Each values was created as an average over time from a linear mixed effects model that adjusted for baseline values.|HRQOL: Baseline, week 12, 14, & 22. IPSS: Baseline, week 3-12, 14, & 22.|||units on a scale||Standard Deviation|Least Squares Mean
679394|NCT01585246|Primary|Feasibility|Assess a Saw Palmetto supplementation protocol for feasibility by evaluation if at least 70% of eligible men consent, and if at least 70% of men enrolled at each dose complete the study.|Baseline to Week 12 for each phase.|Number of men who started||Participants|||Count of Participants
679395|NCT01585038|Secondary|Oxidative Stress Markers|Change in F2-isoprostane levels|Change from baseline to 4 weeks|||pg/mL||Standard Deviation|Mean
679396|NCT01585038|Secondary|Endothelial Activation Markers|Change in soluble vascular cell adhesion molecule-1 levels|Change from baseline to 4 weeks|||pg/mL||Standard Deviation|Mean
679397|NCT01585038|Secondary|Inflammatory Markers|Change in high sensitivity C-reactive protein levels|Change from baseline to 4 weeks|||mg/L||Standard Deviation|Mean
679398|NCT01585038|Primary|Change in Flow-mediated Dilation of the Brachial Artery|This is a measure of in vivo endothelial function|Change from baseline to 4 weeks|||absolute percentage change||Standard Deviation|Mean
679399|NCT01584843|Secondary|Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP|The severity of duction limitation was calculated for participants with paralytic strabismus. For each evaluable participant, assessment was done by taking a frontal photo of the condition of the affected eye to determine the maximum movement toward the direction to which duction was limited while the non-affected eye was masked with eye-patch. The evaluation was performed in the same eye (left or right) throughout the study period. Based on the photos, the severity of the duction limitation was assessed on a 6-point scale, with scores ranging from 0=no duction limitation to -5=cannot rotate eye to midline. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. All participants with paralytic strabismus did not receive a second injection so there were no participants to analyse for this outcome measure.|Baseline and Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP (up to Study Week 52)|FAS2 Population|||||
679415|NCT01584843|Primary|Change From Baseline in Strabismus Angle Prism Dioptre (PD) in the Primary Position at Week 4 of the FTP in Observed Cases (OC)|The strabismus angle in the primary position was measured using the alternative prism cover test (APCT). The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 meters [m]) and the near-view strabismus angle (measured at a distance of 33 centimeters [cm]). Every participant’s evaluation was performed in the same affected eye (left or right) throughout the study period. Change from Baseline was calculated as the value at Week 4 minus the value at Baseline.|Baseline and Week 4 of the FTP|Full Analysis Set (FAS1) Population: all participants who were randomized and had at least one post-Baseline efficacy assessment. Values were summarized for OC of the FTP without imputation of missing values. Only those participants available at the specified time points were analyzed.||prism dioptre||Standard Deviation|Mean
679400|NCT01584843|Secondary|Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP|The severity of duction limitation was calculated for participants with paralytic strabismus. For each evaluable participant, assessment was done by taking a frontal photo of the condition of the affected eye to determine the maximum movement toward the direction to which duction was limited while the non-affected eye was masked with eye-patch. The evaluation was performed in the same eye (left or right) throughout the study period. Based on the photos, the severity of the duction limitation was assessed on a 6-point scale, with scores ranging from 0=no duction limitation to -5=cannot rotate eye to midline. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 after the final injection of the FTP (up to a maximum of 52 weeks of the FTP)|FAS1 Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS1 Population.||Scores on a scale||Standard Deviation|Mean
679401|NCT01584843|Secondary|Change From Baseline in the Severity of Duction Limitation at Weeks 1 and 4 of the FTP|The severity of duction limitation was calculated for participants with paralytic strabismus. For each evaluable participant, assessment was done by taking a frontal photo of the condition of the affected eye to determine the maximum movement toward the direction to which duction was limited while the non-affected eye was masked with eye-patch. The evaluation was performed in the same eye (left or right) throughout the study period. Based on the photos, the severity of the duction limitation was assessed on a 6-point scale, with scores ranging from 0=no duction limitation to -5=cannot rotate eye to midline. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Weeks 1 and 4 of the FTP|FAS1 Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS1 Population.||Scores on a scale||Standard Deviation|Mean
679402|NCT01584843|Secondary|Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP|The severity of duction limitation was calculated for participants with paralytic strabismus. For each evaluable participant, assessment was done by taking a frontal photo of the condition of the affected eye to determine the maximum movement toward the direction to which duction was limited while the non-affected eye was masked with eye-patch. The evaluation was performed in the same eye (left or right) throughout the study period. Based on the photos, the severity of the duction limitation was assessed on a 6-point scale, with scores ranging from 0=no duction limitation to -5=cannot rotate eye to midline. All participants with paralytic strabismus did not receive a second injection so there were no participants to analyse for this outcome measure.|Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP (up to Study Week 52)|FAS2 Population|||||
679403|NCT01584843|Secondary|Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP|The severity of duction limitation was calculated for participants with paralytic strabismus. For each evaluable participant, assessment was done by taking a frontal photo of the condition of the affected eye to determine the maximum movement toward the direction to which duction is limited while the non-affected eye was masked with eye-patch. The evaluation was performed in the same eye (left or right) throughout the study period. Based on the photos, the severity of the duction limitation was assessed on a 6-point scale, with scores ranging from 0=no duction limitation to -5=cannot rotate eye to midline.|Weeks 1, 4, 8, 12, 16, 20, and 24 after the final injection of the FTP (up to a maximum of 52 weeks of the FTP)|FAS1 Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS1 Population.||Scores on a scale||Standard Deviation|Mean
679404|NCT01584843|Secondary|Severity of Duction Limitation at Weeks 1 and 4 of the FTP|The severity of duction limitation was calculated for participants with paralytic strabismus. For each evaluable participant, assessment was done by taking a frontal photo of the condition of the affected eye to determine the maximum movement toward the direction to which duction is limited while the non-affected eye was masked with eye-patch. The evaluation was performed in the same eye (left or right) throughout the study period. Based on the photos, the severity of the duction limitation was assessed on a 6-point scale, with scores ranging from 0=no duction limitation to -5=cannot rotate eye to midline.|Week 1 and Week 4 of the FTP|FAS1 Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS1 Population.||Scores on a scale||Standard Deviation|Mean
679405|NCT01584843|Secondary|Duration of Effect|Duration of effect is defined as the number of days after the final injection of the FTP (after randomization in the non-treatment groups) until the date of the first recording of a value smaller than 50% in percent correction compared to the maximum change in the strabismus angle in the primary position. The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Percent correction compared to the maximum change in the strabismus angle was calculated as: (absolute angle [strabismus angle at Baseline minus the strabismus angle after injection]/absolute angle [strabismus angle at Baseline minus the strabismus angle at maximum change]) multiplied by 100.|Up to Week 48 after the final injection of the FTP (up to Study Week 52)|FAS1 Population||Days||95% Confidence Interval|Median
679406|NCT01584843|Secondary|Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP|The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Every participant’s evaluation was performed in the same affected eye (left or right) throughout the study period. Percent change from Baseline in the strabismus angle was calculated as: (absolute angle [strabismus angle at Baseline minus the strabismus angle after the final injection] divided by the absolute strabismus angle at Baseline) multiplied by 100.|Baseline and Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP (up to Study Week 52)|FAS2 Population||Percent change in prism dioptre||Standard Deviation|Mean
679407|NCT01584843|Secondary|Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP|The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Every participant’s evaluation was performed in the same affected eye (left or right) throughout the study period. The values were summarized for observed cases for percent change from Baseline in the strabismus angle in the primary position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 (before reinjection of the second treatment period if applicable) after the final injection of the FTP (after randomization in non-treatment groups; up to a maximum of 52 weeks of the FTP). Percent change from Baseline in the strabismus angle was calculated as: (absolute angle [strabismus angle at Baseline minus the strabismus angle after the final injection] divided by the absolute strabismus angle at Baseline) multiplied by|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 of the FTP|FAS1 Population||Percent change in prism dioptre||Standard Deviation|Mean
679408|NCT01584843|Secondary|Percent Change From Baseline in the Strabismus Angle in the Primary Position at Week 1 and Week 4 in Observed Cases (OC) of the FTP|The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Every participant’s evaluation was performed in the same affected eye (left or right) throughout the study period. The values were summarized for observed cases for the percent change from Baseline in the strabismus angle in the primary position at Week 1and Week 4 after the initial injection in the FTP. Percent change from Baseline in the strabismus angle was calculated as: absolute angle ([strabismus angle at Baseline minus strabismus angle after the final injection] divided by the absolute strabismus angle at Baseline) multiplied by 100.|Baseline and Weeks 1 and 4 of the FTP|FAS1 Population||Percent change in prism dioptre||Standard Deviation|Mean
679409|NCT01584843|Secondary|Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP|The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Every participant’s evaluation was performed in the same affected eye (left or right) throughout the study period.|Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP (up to Study Week 52)|FAS2 population.||prism dioptre||Standard Deviation|Mean
679410|NCT01584843|Secondary|Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP|The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Every participant’s evaluation was performed in the same affected eye (left or right) throughout the study period. The absolute values of the strabismus angle in the primary position were summarized for observed cases at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 (before reinjection of the second treatment period if applicable) after the final injection of the FTP (after randomization in the non-treatment groups).|Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 after the final injection of the FTP|FAS1 Population||prism dioptre||Standard Deviation|Mean
679411|NCT01584843|Secondary|Absolute Strabismus Angle in the Primary Position at Weeks 1 and 4 of the FTP|The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Every participant’s evaluation was performed in the same affected eye (left or right) throughout the study period. The absolute values of the strabismus angle in the primary position at Week 1 and Week 4 of the FTP were summarized for observed cases without imputation of missing values.|Weeks 1 and 4 of the FTP|FAS1 Population||prism dioptre||Standard Deviation|Mean
679412|NCT01584843|Secondary|Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the Second Treatment Period (STP)|The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Every participant’s evaluation was performed in the same affected eye (left or right) throughout the study period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP (up to Study Week 52)|FAS2 Population: all participants who were included in the FAS1 Population, received reinjection of the investigational product, and had at least one efficacy assessment after the reinjection||prism dioptre||Standard Deviation|Mean
679413|NCT01584843|Secondary|Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP|The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Every participant’s evaluation was performed in the same affected eye (left or right) throughout the study period. The values were summarized for the observed cases for the change in the strabismus angle in the primary position from Baseline at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 (before reinjection of the second treatment period if applicable) after the final injection of the FTP (after randomization in the non-treatment groups). Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 after the final injection of the FTP|FAS1 Population||prism dioptre||Standard Deviation|Mean
679414|NCT01584843|Secondary|Change From Baseline in the Strabismus Angle Prism Dioptre (PD) in the Primary Position at Week 1 After the Initial Injection of the FTP in Observed Cases (OC)|The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Every participant’s evaluation was performed in the same affected eye (left or right) throughout the study period. Change from Baseline was calculated as the value at Week 1minus the value at Baseline.|Baseline and Week 1 of the FTP|FAS1 Population||prism dioptre||Standard Deviation|Mean
679416|NCT01584648|Secondary|Plasma Concentrations of Dabrafenib and Its Metabolites|Blood samples were collected for PK analysis in all participants. Three blood samples were collected at Week 8: pre-dose, 1-3 hours post dose, and 4-6 hours post dose. One pre-dose blood sample was obtained at Weeks 16 and 24. Plasma concentrations of dabrafenib (GSK2118436) and its metabolites (GSK2285403, GSK2298683, and GSK2167542) were determined using the currently approved analytical methodology.|Week 8: pre-dose, 1-3 hours and 4-6 hours post dose; Week 16 pre-dose and Week 24 pre-dose|PK Population.||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
679417|NCT01584648|Secondary|Plasma Concentrations of Trametinib|Blood samples were collected for Pharmacokinetic (PK) analysis in all participants. Three blood samples were collected at Week 8: pre-dose, 1-3 hours post dose, and 4-6 hours post dose. One pre-dose blood sample was obtained at Weeks 16 and 24.|Week 8: pre-dose, 1-3 hours and 4-6 hours post dose; Week 16 pre-dose and Week 24 pre-dose|Pharmacokinetic (PK) Population: all participants included in the safety population for whom a PK sample was obtained and analyzed. Only participants with data available at the specified time points were analyzed.||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
679418|NCT01584648|Secondary|Number of Participants With Incidence of Squamous Cell Carcinoma|Participants were evaluated for the event of squamous cell carcinoma including Keratoacanthoma.|From Baseline up to end of study (average of 9 study months)|Safety Population||Number of events|||Number
679419|NCT01584648|Secondary|Number of Participants With Worst-case On-therapy Change From Baseline in Left Ventricular Ejection Fraction (LVEF) as Assessed by Echocardiogram|Absolute change from Baseline in LVEF were summarized at each scheduled assessment time and in the worst-case post Baseline. Only the post Baseline assessments that used the same method (ECHO or Multi Gated Acquisition Scan [MUGA]) as the Baseline assessments were used to derive the change from Baseline. The change from Baseline was categorized as any increase; no change; and any decrease and as 0-10 decrease, 10 - 19 decrease, >= 20 decrease, >=10 decrease and >= lower limit of normal (LLN), >=10 decrease and <LLN, >10 decrease and <LLN, >= 20 decrease and >= LLN, >= 20 decrease and <LLN. Only those participants with LVEF values for worst-case on-therapy are presented.|From Baseline up to Week 60|Safety Population. Only those participants available at the specified time points were analyzed.||Participants|||Number
679420|NCT01584648|Secondary|Number of Participants With a Worse-case On-therapy Change From Baseline in the Bazett's QTc to Grade 2 or Grade 3|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. Bazett's QTc is categorized as: Grade 0 (<450 milliseconds [msec]), Grade 1 (450-480 msec), Grade 2 (481-500 msec), and Grade 3 (>=501 msec). An increase is defined as an increase in the CTCAE grade relative to the Baseline grade. Participants with missing Baseline values were assumed to have a Baseline value of grade 0. Only those participants with Bazett's QTc values for worst-case on-therapy are presented.|From Baseline up to Week 60|Safety Population. Only those participants available at the specified time points were analyzed.||Participants|||Number
679421|NCT01584648|Secondary|Number of Participants With a Worst-case On-therapy Change From Baseline in Temperature|Change from Baseline in temperature is categorized as a decrease to <=35 degrees celsius (C), change to normal or no change as 35-38 degrees C, and increase to >=38 degrees C. Participants with a missing Baseline value are assumed to have a normal Baseline value. Participants were counted twice if the participant temperature value decreased to <=35 degrees C and increased to >=38 degrees C post-Baseline. Only those participants with temperature values for worst-case on-therapy are presented.|From Baseline up to Week 64|Safety Population. Only those participants available at the specified time points were analyzed.||Participants|||Number
679422|NCT01584648|Secondary|Number of Participants With a Worst-case On-therapy Change From Baseline in Systolic and Diastolic Blood Pressure to Grade 2 or Grade 3|Change from Baseline in systolic blood pressure (SBP) is categorized as: Grade 0 (<120 millimeters of mercury [mmHg]), Grade 1 (120-139 mmHg), Grade 2 (140-159 mmHg), and Grade 3 (>=160 mmHg). Change from Baseline in diastolic blood pressure (DBP) is categorized as: Grade 0 (<80 mmHg), Grade 1 (80-89 mmHg), Grade 2 (90-99 mmHg), and Grade 3 (>=100 mmHg). An increase is defined as an increase in the CTCAE grade relative to the Baseline grade. Participants with missing Baseline values were assumed to have a Baseline value of grade 0. Only those participants with blood pressure values for worst-case on-therapy are presented.|From Baseline up to Week 64|Safety Population. Only those participants available at the specified time points were analyzed.||Participants|||Number
679423|NCT01584648|Secondary|Number of Participants With a Worst-case On-therapy Change From Baseline in Heart Rate|Change from Baseline in heart rate is categorized as decrease to <60 beats per minute (bpm), change to normal or no change, and increase to >100 bpm. Participants with a missing Baseline value are assumed to have a normal Baseline value. Participants were counted twice if the participant heart rate value decreased to <60 bpm and increased to >100 bpm post-Baseline. Only those participants with heart rate values for worst-case on-therapy are presented.|From Baseline up to Week 64|Safety Population. Only those participants available at the specified time points were analyzed.||Participants|||Number
679424|NCT01584648|Secondary|Number of Participants With a Worst-case On-therapy Change From Baseline With Respect to the Normal Range for the Indicated Clinical Chemistry Parameters|Clinical chemistry tests where the toxicity grade is not defined by NCI-CTCAE includes chloride, creatinine clearence, lactate dehydrogenase, urea, protein and carbon dioxide. Change from Baseline is categorized as decrease to low, change to normal or no change, increase to high in reference to the normal range. Only those participants with laboratory values for worst-case on-therapy are presented. For the worst-case on-therapy, participants were counted twice if the participant lab value decreased to low and increased to high during the on-therapy period.|From Baseline up to Week 64|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Safety Population.||Participants|||Number
679465|NCT01583543|Secondary|Number of Participants Experiencing a Grade 3 or 4 Clinically Significant and Related Adverse Event|Adverse events were graded according to CTCAE v.4 (Common Terminology Criteria for Adverse Events). Events are graded on a scale of 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = fatal. Only events that are clinically significant and which the treating investigator considers to be related to administration of olaparib are counted for this outcome measure.|2 years|||Participants|||Count of Participants
679466|NCT01583543|Secondary|Overall Survival|Number of patients survived for 2 years after enrolling onto this study.|Two years|||Participants|||Count of Participants
679425|NCT01584648|Secondary|Number of Participants With a Worst-case On-therapy Change From Baseline With Respect to the Normal Range for the Indicated Hematology Parameters|Hematology tests where the toxicity grade is not defined by NCI-CTCAE includes basophils, eosinophils and monocytes. Change from Baseline is categorized as a decrease to low, change to normal or no change, increase to high in reference to the normal range. Only those participants with laboratory values for worst-case on-therapy are presented. For the worst-case on-therapy, participants were counted twice if the participant lab value decreased to low and increased to high during the on-therapy period.|From Baseline up to Week 64|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Safety Population.||Participants|||Number
679426|NCT01584648|Secondary|Number of Participants With a Worst-case On-therapy Grade Change From Baseline to Grade 3 and 4 for the Indicated Hematology Parameters|Hematology data were summarized according to NCI-CTCAE grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3, Severe, or disabling; Grade 4, Life-threatening; Grade 5, Death related to AE. Data are presented for only those parameters for which an increase to Grade 3 or Grade 4 occurred. Hematology tests where the toxicity grade is defined by NCI-CTCAE includes hemoglobin, lymphocytes, neutrophils, platelets and leukocytes. Participants with missing Baseline grades were assumed to have a Baseline grade of 0. Only those participants with laboratory values for worst-case on-therapy are presented. Worst-case on-therapy included both scheduled and unscheduled visits.|From Baseline up to Week 64|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Safety Population.||Participants|||Number
679427|NCT01584648|Secondary|Number of Participants With a Worst-case On-therapy Grade Change From Baseline to Grade 3 and 4 for the Indicated Clinical Chemistry Parameters|Clinical chemistry data were summarized according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3, Severe or disabling; Grade 4, Life-threatening; Grade 5, Death related to AE. Data are presented for only those parameters for which an increase to Grade 3 or Grade 4 occurred. Clinical chemistry tests where the toxicity grade is defined by NCI-CTCAE includes albumin, alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, calcium, glucose, potassium, sodium, creatinine and phosphate. Participants with missing Baseline grades were assumed to have a Baseline grade of 0. Only those participants with laboratory values for worst-case on-therapy are presented. Worst-case on-therapy included both scheduled and unscheduled visits.|From Baseline up to Week 64|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Safety Population.||Participants|||Number
679428|NCT01584648|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a par., temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Protocol specific SAEs included: ALT≥3XULN and total bilirubin ≥2XULN (35% direct) or ALT ≥3XULN and INR >1.5 (if INR is measured); any new malignancy with a histology different from the primary tumor; left ventricular ejection fraction that met stopping criteria; central serous retinopathy or retinal vein occlusion; pyrexia accompanied by ≥grade 3 hypotension, or hypotension that is clinically significant as judged by the investigator, dehydration requiring IV fluids, or severe rigor/chills. Refer to the general AE/SAE module for a list of AEs and SAEs.|From the time the first dose of study treatment administered until 30 days after discontinuation of study treatment (average of 9 study months)|Safety Population: all randomized participants who received at least one dose of study medication and were based on the actual treatment received if this differed from that to which the participant was randomized.||Participants|||Number
679429|NCT01584648|Secondary|Duration of Response for Participants With a Confirmed Response (Complete Response or Partial Response)|Duration of response is defined as the time (in months) from the first documented complete response (CR: the disappearance of all target lesions and any pathological lymph nodes must have a short axis of <10 mm and the disappearance of all non-target lesions) or partial response (PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters or the persistence of 1 or more non-target lesions or lymph nodes identified as a site of disease at Baseline with a short axis of ≥10mm) until disease progression (PD). PD is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5mm or the appearance of one or more new lesions, or the worsening of non target lesions significant enough to require study treatment discontinuation. PD was based on the radiological evidence by investigator.|From the time of the first documented response (CR or PR) until disease progression (average of 9 study months)|ITT population. Only those participants with a confirmed CR or PR were analyzed (with or without measurabe disease at Baseline).||Months||95% Confidence Interval|Median
679430|NCT01584648|Secondary|Number of Participants With a Confirmed Response (Complete Response or Partial Response)|A participant was defined as a responder if he/she sustained a complete response (CR: the disappearance of all target lesions and any pathological lymph nodes must have a short axis of <10 mm and the disappearance of all non-target lesions) or partial response (PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters or the persistence of 1 or more non-target lesions or lymph nodes identified as a site of disease at Baseline with a short axis of ≥10mm).|From randomization until the first documented complete response or partial response (average of 9 study months)|ITT Population. Only participants with measurable disease at Baseline per RECIST were analyzed.||Participants|||Number
679431|NCT01584648|Secondary|Overall Survival (OS)|OS is defined as the interval of time (in months) between the date of randomization and the date of death due to any cause. For participants who did not die, time of death was censored at the date of last contact.|From randomization until death due to any cause (average of 9 study months)|ITT Population||Months||95% Confidence Interval|Median
679432|NCT01584648|Primary|Progression-Free Survival (PFS) as Assessed by the Investigator|Progression-free survival (PFS) is defined as the time (in months) from the date of randomization to the first documented occurrence of PD or death. Investigator PFS was summarized per response evaluation criteria in solid tumors (RECIST, version 1.1) which is a set of published criteria defining when cancer patients improve (respond), stay the same (stable) or worsen (progress). PD is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5mm or the appearance of one or more new lesions, or the worsening of non target lesions significant enough to require study treatment discontinuation. For participants who had not progressed or died at the time of the analysis, censoring was performed at the last adequate disease assessment.|From randomization until the earliest date of disease progression (PD) or death due to any cause (average of 9 study months)|Intent-to-Treat (ITT) Population: all randomized participants regardless of whether or not they received the study treatment. Any participant who received a treatment randomization number was considered to have been randomized.||Months||95% Confidence Interval|Median
679433|NCT01584544|Primary|Number of Participants Experienced Dose Limited Toxicity|Dose related toxicity is defined as follows:1. luecopenia > grade 2; granular cell decrease > grade 2; anemia > grade 1; platelet > grade 1;SGPT/SGOT elevation > grade 1; ALP > grade 1; GGT > grade 1; Tbil > grade 1;renal function damag > grade 2;Non-gradular cell decreased fever > grade 1;nausea/vomiting > grade 1; fatigue > grade 2; weight loss > grade 2;gastritis > grade 2; dairrea > grade 2; abdominal pain > grade 2; upper gastrointestinal bleeding > grade 1;other toxic reaction > grade 2;KPS < 50 during the treatment|up to 7 weeks from start of the treatment|||participants|||Number
679434|NCT01584518|Primary|Length of Stay|The subjects will be evaluated preoperatively and followed post-operatively until discharge from the hospital. Length of stay|From date of admission until date of discharge, assessed up to 1 month|||days||Standard Deviation|Mean
679435|NCT01584479|Secondary|Change in Evaluation for Dental Caries and Oral Cancer Within the Risk Categories||10 and 15 years||||||
679436|NCT01584479|Secondary|Change in Relationship of Risk Category & Tooth Loss Rate With Systemic Disease History on Questionnaire.||10 and 15 years||||||
679437|NCT01584479|Secondary|Change in Periodontal Surgery Claims||10 and 15 years||||||
679438|NCT01584479|Secondary|Change in Total Periodontal Claims During the Monitoring Period||10 and 15 years||||||
679439|NCT01584479|Secondary|Change in Total Dental Claims During Monitoring Period||10 and 15 years||||||
679440|NCT01584479|Primary|Percentage of Participants With Tooth Loss Over 16 Year Period|Tooth loss rate over 16 years was calculated as the cumulative percentage of participants with tooth loss over 16 years.|16 years|||percentage of participants|||Number
679441|NCT01584388|Secondary|Time to Complete Remission|Treatment phase up to 52 weeks (365 days)|Days|||Days||Standard Deviation|Mean
679442|NCT01584388|Secondary|Time to Relapse|Treatment phase up to 52 weeks (365 days)|Days|||Days||Standard Deviation|Mean
679443|NCT01584388|Secondary|Time to Disease Response|Treatment phase up to 52 weeks (365 days)|Mean days +/- standard deviation|||Days||Standard Deviation|Mean
679444|NCT01584388|Secondary|Complete Remission (Any Timepoint), Exclusive of Serum IgG4|IgG4-RD RI = 0 (exclusive of serum IgG4) at any point in the trial|12 months|||Participants|||Count of Participants
679445|NCT01584388|Secondary|Complete Remission at Any Timepoint|IgG4-RD RI = 0 at any point in the trial|12 months|||Participants|||Count of Participants
679446|NCT01584388|Secondary|Complete Remission IgG-RD RI (Exclusive of Serum IgG4) of 0 at 6 Months.|IgG-RD RI (exclusive of serum IgG4) of 0 at 6 months.|6 months|||Participants|||Count of Participants
679447|NCT01584388|Secondary|Complete Remission|IgG4-RD RI (including serum IgG4) of 0 at six months|6 months|||Participants|||Count of Participants
679448|NCT01584388|Secondary|Sustained Disease Response|Decline of the IgG4-RD RI by at least two points and maintained for 12 months.|12 months|||Participants|||Count of Participants
679449|NCT01584388|Secondary|Disease Response at 6 Months|Decline of IgG4-RD Responder Index by at least two points for at least 6 months|6 months|||Participants|||Count of Participants
679450|NCT01584388|Secondary|Retreatment With Rituximab for Disease Relapse|Number of subjects that relapsed during the course of the trial|12 months|||Participants|||Count of Participants
679451|NCT01584388|Primary|No Disease Flares During Rituximab Treatment Phase|"Disease flare measured by responder Index score:
At each assessment, the physician enters a 0-4 score after the organ/site listed with:
0 = Normal or resolved
= Improved but still present
= Persistent (still active; unchanged from previous visit)
= New or recurrent disease activity while patient is off treatment
= Worsened or new disease despite treatment Definitions Organ/Site score: The overall level of IgG4-RD activity within a specific organ system Symptomatic: Is the disease manifestation in a particular organ system symptomatic? (Y = yes; N = no) Urgent disease: Disease that requires treatment immediately to prevent serious organ dysfunction (Y = yes; N = no) (Presence of urgent disease within an organ leads to DOUBLING of that organ system score) Damage: Organ dysfunction that has occurred as a result of IgG4-RD and is considered permanent (Y = yes; N = no)"|Month 6|number of subjects without disease flares during baseline to 6 month of treatment||Participants|||Count of Participants
679452|NCT01584388|Primary|Cumulative Glucocorticoid Use at Baseline and 6 Months|Cumulative glucocorticoid therapy between baseline and 6 months.|6 months|cumulative glucocorticoid use at 6 and compare them to baseline using paired T tests.||mg||Full Range|Mean
679453|NCT01584388|Primary|IgG4-RD RI Score at Baseline and Six Months After Rituxan Treatment|"The IgG4-RD RI is then calculated by adding the individual organ scores.At each assessment, the physician enters a 0-4 score after the organ/site listed with:
0 = Normal or resolved
= Improved but still present
= Persistent (still active; unchanged from previous visit)
= New or recurrent disease activity while patient is off treatment
= Worsened or new disease despite treatment Definitions Organ/Site score: The overall level of IgG4-RD activity within a specific organ system Symptomatic: Is the disease manifestation in a particular organ system symptomatic? (Y = yes; N = no) Urgent disease: Disease that requires treatment immediately to prevent serious organ dysfunction (Y = yes; N = no) (Presence of urgent disease within an organ leads to DOUBLING of that organ system score) Damage: Organ dysfunction that has occurred as a result of IgG4-RD and is considered permanent (Y = yes; N = no)
The Responder Index ranges from 0-60."|6 months|||units on a scale||Standard Deviation|Mean
679467|NCT01583543|Secondary|Progression-Free Survival|Number of patients with progression free survival after two years from starting the trial.|Two years|||Participants|||Count of Participants
679454|NCT01584232|Secondary|Percentage of Participants With Hypoglycemic Episodes|The percentage of participants with hypoglycemic episodes was calculated by dividing the number of participants with at least one hypoglycemic episode over the 26-week treatment period by the total number of participants analyzed, multiplied by 100%. All classifications of hypoglycemia (documented symptomatic, asymptomatic, severe, nocturnal, non-nocturnal, probable symptomatic, relative, and unspecified) were included, except for episodes of relative hypoglycemia that were not severe. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or insulin glargine. Only pre-rescue data was used.||percentage of participants|||Number
679455|NCT01584232|Secondary|Change From Baseline in Body Weight at 26 Weeks|Least squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, visit, treatment-by-visit, oral antihyperglycemic medication regimen (sulfonylureas only, biguanides only, or both), and baseline body mass index (BMI) group (<25 or >=25 kilograms per meter squared [kg/m^2]) as fixed effects, baseline body weight as a covariate, and participant as a random effect.|Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265 or insulin glargine with evaluable body weight data. Only pre-rescue measurements were used.||kilograms (kg)||Standard Error|Least Squares Mean
679456|NCT01584232|Secondary|Change From Baseline in 8-Point Self-Monitored Blood Glucose (SMBG) at 26 Weeks|Participants were to test and record SMBG concentrations in their study diaries before each meal (breakfast, lunch, and dinner), approximately 2 hours after the start of each meal, at bedtime, and before breakfast the next morning (second pre-morning meal). Least squares (LS) means were calculated using analysis of covariance (ANCOVA) model with treatment, oral antihyperglycemic medication regimen (sulfonylureas only, biguanides only, or both), and baseline body mass index (BMI) group (<25 or >=25 kilograms per meter squared [kg/m^2]) as fixed effects and baseline SMBG as a covariate.|Baseline, Up to 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265 or insulin glargine with evaluable SMBG data. Only pre-rescue measurements were used. Missing endpoints were imputed with the last observation carried forward (LOCF), using only postbaseline data.||milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
679457|NCT01584232|Secondary|Change From Baseline in Fasting Blood Glucose (FBG) at 26 Weeks|Least squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, visit, treatment-by-visit, oral antihyperglycemic medication regimen (sulfonylureas only, biguanides only, or both), and baseline body mass index (BMI) group (<25 or >=25 kilograms per meter squared [kg/m^2]) as fixed effects, baseline FBG as a covariate, and participant as a random effect.|Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265 or insulin glargine with evaluable fasting blood glucose data. Only pre-rescue measurements were used.||milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
679458|NCT01584232|Secondary|Percentage of Participants Who Achieved Glycosylated Hemoglobin (HbA1c) <=6.5% or <7% at 26 Weeks|The percentage of participants achieving HbA1c level less than 7.0% and less than or equal to 6.5% was analyzed with a longitudinal logistic regression model with treatment, visit, treatment-by-visit, oral antihyperglycemic medication regimen (sulfonylureas only, biguanides only, or both), and baseline body mass index (BMI) group (<25 or >=25 kilograms per meter squared [kg/m^2]) as fixed effects, baseline HbA1c as a covariate, and participant as a random effect.|Up to 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265 or insulin glargine with evaluable HbA1c data. Only pre-rescue measurements were used. Missing endpoints were imputed with the last observation carried forward (LOCF), using only postbaseline data.||percentage of participants|||Number
679459|NCT01584232|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 26 Weeks|Least squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, visit, treatment-by-visit, oral antihyperglycemic medication regimen (sulfonylureas only, biguanides only, or both), and baseline body mass index (BMI) group (<25 or >=25 kilograms per meter squared [kg/m^2]) as fixed effects, baseline HbA1c as a covariate, and participant as a random effect.|Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265 or insulin glargine with evaluable HbA1c data. Only pre-rescue measurements were used.||percentage of HbA1c||Standard Error|Least Squares Mean
679460|NCT01583894|Primary|Multi-site Pain Index|"Multiple Site Pain Index (MSPI) was developed by collating multiple pain descriptors into a single index. Pain descriptors used for developing this index were percent body area in pain, number of painful areas, span of painful areas, and Regional Pain Ratings (RPRs) which includes data on pain severity and pain continuity for 47 body regions.
MSPI score ranged from 0 to 1; 0 representing no pain and 1 representing extreme continuous pain over entire body, except the head and face regions."|single-visit|MSPI was calculated using multiple pain descriptors which were obtained from pain drawings. 810 of the 813 patients that completed the study provided complete pain drawing data, and so MSPI could be calculated only in 810 patients.||units on a scale||Standard Deviation|Mean
679461|NCT01583647|Primary|Plasma Cmax of Nicotinuric Acid (NUA)||Predose on Day 1 up to 48 hours postdose|The study was terminated during Panel A and the decision was made to not analyze the blood and urine pharmacokinetic samples collected during Panel A; Panel B was not conducted.|||||
679462|NCT01583647|Primary|Total Urinary Excretion of Niacin and Niacin Metabolites||Predose on Day 1 up to 72 hours postdose|The study was terminated during Panel A and the decision was made to not analyze the blood and urine pharmacokinetic samples collected during Panel A; Panel B was not conducted.|||||
679463|NCT01583647|Primary|Plasma Maximum Concentration (Cmax) of Laropiprant||Predose on Day 1 up to 48 hours postdose|The study was terminated during Panel A and the decision was made to not analyze the blood and urine pharmacokinetic samples collected during Panel A; Panel B was not conducted.|||||
679464|NCT01583647|Primary|Plasma Area Under the Concentration Curve From 0 to Infinity (AUC0-∞) of Laropiprant||Predose Day 1 up to 24 hours postdose|The study was terminated during Panel A and the decision was made to not analyze the blood and urine pharmacokinetic samples collected during Panel A; Panel B was not conducted.|||||
679468|NCT01583543|Primary|Objective Response Rate of Olaparib|"Number of participants with objective response rate as defined as PR+CR as determined by RECIST vs. 1.1.
Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|2 years|||Participants|||Count of Participants
679469|NCT01583530|Secondary|Number of Participants Who Experienced Adverse Events|Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).|Up to Day 119|Analyses were performed on the as-treated population, defined as the set of all participants who received at least 1 partial or full dose of treatment with the assignment to treatment group that was based on the actual treatment administered to the participants.||participants|||Number
679470|NCT01583530|Secondary|Absolute Bioavailability of Weekly (x 4) SC Injections of Belimumab|Bioavailability (F) is a measurement of the rate and extent to which a drug reaches the systemic circulation. The bioavailability following weekly (x 4) SC injections of belimumab was calculated by comparing the bioavailability of belimumab administered IV to the bioavailability of belimumab administered via 4 weekly SC injections.|Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 22, 23, 24, 25, 26, 27, 28, 31, 35, 42, 49, 63, 77, 91, and 119|The pharmacokinetic parameter analysis set included all participants who had received 4 weekly doses of belimumab and had serum concentration data available through 7 weeks from first dose. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||percentage bioavailability||90% Confidence Interval|Mean
679471|NCT01583530|Secondary|Terminal Elimination Half-life (t1/2,Term) Following Weekly (x 4) SC Injections of Belimumab|Terminal elimination half-life is the time measured for the serum drug concentration of belimumab to decrease by one half.|Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 22, 23, 24, 25, 26, 27, 28, 31, 35, 42, 49, 63, 77, 91, and 119|The pharmacokinetic parameter analysis set included all participants who had received 4 weekly doses of belimumab and had serum concentration data available through 7 weeks from first dose. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||days||Standard Deviation|Mean
679472|NCT01583530|Secondary|Area Under the Serum Drug Concentration-time Curve From Time 0 to Infinite Time (AUC0-∞) Following Weekly (x 4) SC Injections of Belimumab|AUC (0-∞) = Area under the serum drug concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-last) plus C (last)/λz. C (last) is the last measurable concentration. λz was determined by linear regression (r2 ≥ 0.8) with uniform weighting of all data in the terminal linear portion of the log-transformed drug concentration-time profile.|Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 22, 23, 24, 25, 26, 27, 28, 31, 35, 42, 49, 63, 77, 91, and 119|The pharmacokinetic parameter analysis set included all participants who had received 4 weekly doses of belimumab and had serum concentration data available through 7 weeks from first dose. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||µg∙day/mL||Geometric Coefficient of Variation|Geometric Mean
679473|NCT01583530|Secondary|Maximum Serum Drug Concentration (Cmax) Following Weekly (x 4) SC Injections of Belimumab||Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 22, 23, 24, 25, 26, 27, 28, 31, 35, 42, 49, 63, 77, 91, and 119|The pharmacokinetic parameter analysis set included all participants who had received 4 weekly doses of belimumab and had serum concentration data available through 7 weeks from first dose. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
679474|NCT01583530|Primary|Absolute Bioavailability of a Single Dose of Belimumab Given as IV or SC|Bioavailability (F) is a measurement of the rate and extent to which a drug reaches the systemic circulation. The bioavailability of belimumab administered by IV is compared to the bioavailability of belimumab administered via single-SC injection.|Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70|The pharmacokinetic parameter analysis set included all participants who had received at least 1 dose of belimumab and had serum concentration data available through the Day 28 visit. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||percentage bioavailability||90% Confidence Interval|Mean
679475|NCT01583530|Primary|Terminal Elimination Half-life (t1/2,Term) Following a Single Dose of Belimumab Given as IV or SC|Terminal elimination half-life is the time measured for the serum drug concentration of belimumab to decrease by one half.|Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70|The pharmacokinetic parameter analysis set included all participants who had received at least 1 dose of belimumab and had serum concentration data available through the Day 28 visit. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||days||Standard Deviation|Mean
679476|NCT01583530|Primary|Area Under the Serum Drug Concentration-time Curve From Time 0 to Infinite Time (AUC0-∞) Following a Single Dose of Belimumab Given as IV or SC|AUC (0-∞) = Area under the serum drug concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-last) plus C (last)/λz. C (last) is the last measurable concentration. λz was determined by linear regression (r2 ≥ 0.8) with uniform weighting of all data in the terminal linear portion of the log-transformed drug concentration-time profile.|Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70|The pharmacokinetic parameter analysis set included all participants who had received at least 1 dose of belimumab and had serum concentration data available through the Day 28 visit. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||µg∙day/mL||Geometric Coefficient of Variation|Geometric Mean
679477|NCT01583530|Primary|Maximum Serum Drug Concentration (Cmax) Following a Single Dose of Belimumab Given as IV or SC||Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70|The pharmacokinetic parameter analysis set included all participants who had received at least 1 dose of belimumab and had serum concentration data available through the Day 28 visit. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
679478|NCT01583530|Secondary|Time to Reach Maximum Serum Drug Concentration (Tmax) Following Weekly (x 4) SC Injections of Belimumab||Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 22, 23, 24, 25, 26, 27, 28, 31, 35, 42, 49, 63, 77, 91, and 119|The pharmacokinetic parameter analysis set included all participants who had received 4 weekly doses of belimumab and had serum concentration data available through 7 weeks from first dose. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||days||Standard Deviation|Mean
680722|NCT01566162|Primary|Safety - Treatment-emergent Adverse Events (TEAEs), TEAEs Leading to Discontinuation, and Serious AEs (SAEs)|Number of subjects with treatment-emergent adverse events (TEAEs), TEAEs leading to discontinuation, and serious AEs (SAEs)|12 weeks|||participants|||Number
679479|NCT01583530|Primary|Time to Reach Maximum Serum Drug Concentration (Tmax) Following a Single Dose of Belimumab Given as Intravenous Infusion (IV) or Subcutaneous Injection (SC)||Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70|The pharmacokinetic parameter analysis set included all participants who had received at least 1 dose of belimumab and had serum concentration data available through the Day 28 visit. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||days||Full Range|Median
679480|NCT01583452|Secondary|Time to Tolerate Feedings (Oral Intake)|The time between the end of surgery to the moment in which the patient can tolerate the intake of fluids or any type of food.|End of surgery to oral intake tolerance (from 1 to 3 days)|Patients who underwent open or laparoscopic appendectomy and received chewing gum plus standard pharmacologic care, or just pharmacologic care (control group), as a measure to prevent post-operative ileus.||hours||Standard Deviation|Mean
679481|NCT01583452|Secondary|Time to First Bowel Movement|The time between the end of surgery and the moment in which the patient presents first bowel movement.|End of surgery to first bowel motion (from 1 to 7 days)|Patients who underwent open or laparoscopic appendectomy and received chewing gum plus standard pharmacologic care, or just pharmacologic care (control group), as a measure to prevent post-operative ileus.||hours||Standard Deviation|Mean
679482|NCT01583452|Secondary|Time to First Flatus|The time between the end of surgery and the moment in which the patient passes first flatus|End of surgery to first flatus (from 1 to 3 days)|Patients who underwent open or laparoscopic appendectomy and received chewing gum plus standard pharmacologic care, or just pharmacologic care (control group), as a measure to prevent post-operative ileus.||hours||Standard Deviation|Mean
679483|NCT01583452|Primary|Post-Operative Hospital Stay|The time between the end of surgery and hospital discharge, measured in hours|End of surgery to hospital discharge (from 4 to 7 days)|Patients who underwent open or laparoscopic appendectomy and received chewing gum plus standard pharmacologic care, or just pharmacologic care (control group), as a measure to prevent post-operative ileus.||hours||Standard Deviation|Mean
679484|NCT01583374|Secondary|Number of Treatment Emergent Adverse Events (TEAEs) During the Placebo Controlled Period|A TEAE is an adverse event with a start date on or after the date of the first dose of investigational product (IP) and no later than 28 days after the last dose of IP for participants who discontinued early. An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant’s health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a pre existing condition) should be considered an AE. A serious AE is any which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect; constitutes an important medical event.|During placebo-controlled period; up to week 24|Safety population includes all participants who were randomized and received at least one dose of IP. Includes data through Week 16 for placebo-treated and apremilast 20 mg BID treated participants who escaped early and data up to Week 24 for all other participants.||participants|||Number
679485|NCT01583374|Secondary|Change From Baseline in the Radiographic Score Using the Modified Stoke Ankylosing Spondylitis Spine Score (m-SASSS) at Week 260|The modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) is a scoring method used by experts to determine the amount or degree of ankylosing spondylitis disease that is in the spine based on x-ray radiographs of the spine.|Baseline and Week 260||12/2019||||
679486|NCT01583374|Secondary|Change From Baseline in the Radiographic Score Using the Modified Stoke Ankylosing Spondylitis Spine Score (m-SASSS) at Week 104|The modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) is a scoring method used by experts to determine the amount or degree of ankylosing spondylitis disease that is in the spine based on x-ray radiographs of the spine.|Baseline and Week 104||12/2019||||
679487|NCT01583374|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Metrology Index-Linear (BASMI-Linear) at Week 24|The BASMI-Linear was designed to assess axial status (ie, cervical, dorsal and lumbar spine, hips, and pelvic soft tissue) and to define clinically significant changes in spinal movement. Five dimensions of movement (lateral lumbar flexion, tragus to wall, forward lumbar flexion, maximal intermalleolar distance, and cervical rotation) are measured and normalized on 0 to 10 unit NRS. The average of these scores is the total BASMI score, with a higher value indicating more severe limitation in spinal mobility|Baseline and Week 24||12/2019||||
679488|NCT01583374|Secondary|Change From Baseline in the Physical Component Summary Score (PCS) of Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) at Week 24|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement|Baseline and Week 24||12/2019||||
679489|NCT01583374|Secondary|Change From Baseline in the Ankylosing Spondylitis Quality of Life (ASQoL) at Week 24|The ASQoL is a validated disease specific patient reported outcomes instrument to assess the impact of ankylosing spondylitis (AS) on the quality of life of individuals with emphasis on the ability of the person to fulfill his or her needs. It consists of 18 items requesting a yes (score=1) or no (score=0) response to questions related to the impact of pain on sleep, mood, motivation, ability to cope, activities of daily living, independence, relationships, and social life. The summary score ranges 0–18 with higher scores indicating worse quality of life|Baseline and Week 24||12/2019||||
679510|NCT01582880|Primary|Changes in Corneal Thickness at 2 Millimeter|The average carrier graft thickness over the first year of postoperative follow-up. The corneal thickness was measured at each visit using AS-OCT imaging 2 mm away from the KPro stem at 3, 6, 9, and 12 o'clock. The individual corneal thickness measurements (3, 6, 9, and 12 o'clock) where then averaged. The average corneal thickness measurements for week 4, 6, 26, 32 and 52 are reported below.|measured at week 4, 6, 26, 32, 52|52 year old white male patient||micrometer|||Number
679490|NCT01583374|Secondary|Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society 20 (ASAS 20) at Week 24, Compared Between Apremilast 20 mg and Placebo|"ASAS 20 is defined as achieving an improvement from baseline of ≥ 20% and ≥ 1 unit in at least 3 of 4 ASAS domains on a scale of 0 to 10 units and no worsening from baseline of ≥ 20% and ≥ 1 unit in the remaining ASAS domain on a scale of 0 to 10 units. The 4 ASAS domains are:
Patient Global Assessment of Disease (0 - 10 unit Numerical Rating Scale [NRS]); participant marks a box with an X on a 0 - 10 unit NRS; the left-hand box of 0 = not active and the right-hand box = very active
Total Back Pain (0 to 10 unit NRS); participant marks a box with an X on a 0 - 10 unit NRS; the left-hand box of 0 = “no pain” and the right-hand box = “most severe pain”
Function (Bath AS Functional Index [BASFI] NRS 0 - 10 unit); participant provides a self-administered survey of 10 questions assessing for degree of mobility and functional ability
Inflammation domain is determined by the mean of 2 Bath AS Disease Activity Index NRS Questions #5 and #6 for morning stiffness) (0 - 10 unit)"|Baseline and Week 24||12/2019||||
679491|NCT01583374|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24|The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is a composite score based on a participant self-administered survey of six questions using a 0 to 10 unit numerical rating scale (NRS) that assesses the participants' five major symptoms of AS: 1) fatigue; 2) spinal pain; 3)peripheral joint pain/swelling; 4) areas of localized tenderness; 5a) morning stiffness severity upon wakening; 5b) morning stiffness duration upon wakening. The participant will be asked to mark the box with an X on a 0 to 10 unit NRS for each of the 6 questions. To give each of the five symptoms equal weighting, the mean of the two scores relating to morning stiffness is taken. The resulting 0 to 50 score is divided by 5 to give a final 0 to 10 BASDAI score. A BASDAI score of 4 or greater is considered to be indicative of active AS disease.|Baseline and Week 24||12/2019||||
679492|NCT01583374|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 24|The Bath Ankylosing Spondylitis Functional Index (BASFI) is a composite score based on a participant self-administered survey of ten questions using a 0 to 10 unit numerical rating scale (NRS) that assesses a participants' degree of mobility and functional ability. The questionnaire consists of eight questions regarding function in AS and the two last questions reflecting the participants' ability to cope with everyday life. The participant will be asked to mark the box with an X on a 0 to 10 unit NRS for each of the 10 questions, on which the left-hand box of 0 represents “easy,” and the right-hand box represents “impossible.” The resulting 0 to 100 score is divided by 10 to give a final 0 to 10 BASFI score. A higher BASFI score correlates to reduced functional ability.|Baseline and Week 24||12/2019||||
679493|NCT01583374|Primary|Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society 20 (ASAS 20) for the Comparison Between Apremilast 30 mg BID and Placebo at 16 Week of Treatment|"ASAS 20 is defined as achieving an improvement from baseline of ≥ 20% and ≥ 1 unit in at least 3 of 4 ASAS domains on a scale of 0 to 10 units and no worsening from baseline of ≥ 20% and ≥ 1 unit in the remaining ASAS domain on a scale of 0 to 10 units. The 4 ASAS domains are:
Patient Global Assessment of Disease (0 - 10 unit Numerical Rating Scale [NRS]); participant marks a box with an X on a 0 - 10 unit NRS; the left-hand box of 0 = not active and the right-hand box = very active
Total Back Pain (0 to 10 unit NRS); participant marks a box with an X on a 0 - 10 unit NRS; the left-hand box of 0 = “no pain” and the right-hand box = “most severe pain”
Function (Bath AS Functional Index [BASFI] NRS 0 - 10 unit); participant provides a self-administered survey of 10 questions assessing for degree of mobility and functional ability
Inflammation domain is determined by the mean of 2 Bath AS Disease Activity Index NRS Questions #5 and #6 for morning stiffness) (0 - 10 unit)"|Baseline and Week 16|The mITT population who were randomized to apremilast (APR) 30 mg BID or placebo and received at least one dose of investigational product. The APR 20mg dose was an exploratory endpoint.||percentage of participants|||Number
679494|NCT01583218|Secondary|mITT: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, or VTE-related Death, Through Visit 3|mITT: Percentage of participants experiencing either symptomatic DVT, non-fatal PE, or VTE related death adjudicated by a blinded independent CEC between randomization and on or before Visit 3 or Day 42 if patient did not have a Visit 3. Visit 3 is between day 35-42 after randomization (day 1).|mITT: Between randomization and Day 42 (max)|The mITT population which consisted of all participants who had taken at least one dose of study drug and who had follow-up assessment data on one or more primary or secondary efficacy components.||Percentage of Participants||95% Confidence Interval|Number
679495|NCT01583218|Secondary|mITT Cohort 2: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, or VTE-related Death, Through Visit 3|mITT Cohort 2: Percentage of participants experiencing either symptomatic DVT, non-fatal PE, or VTE related death adjudicated by a blinded independent CEC between randomization and on or before Visit 3 or Day 42 if patient did not have a Visit 3. Visit 3 is between day 35-42 after randomization (day 1).|mITT Cohort 2: Between randomization and Day 42 (max)|"Cohort 2 (encompasses both participants over 75 and participants with baseline D-dimer ≥ 2 x ULN as determined by the local lab) of the mITT population which consisted of all participants who had taken at least one dose of study drug and who had follow-up assessment data on one or more primary or secondary efficacy components."||Percentage of Participants||95% Confidence Interval|Number
679496|NCT01583218|Secondary|mITT Cohort 1: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, or VTE-related Death, Through Visit 3|mITT Cohort 1: Percentage of participants experiencing either symptomatic DVT, non-fatal PE, or VTE related death adjudicated by a blinded independent CEC between randomization and on or before Visit 3 or Day 42 if patient did not have a Visit 3. Visit 3 is between day 35-42 after randomization (day 1).|mITT Cohort 1: Between randomization and Day 42 (max)|Cohort 1 (participants with baseline D-dimer ≥ 2 x ULN as determined by the local lab) of the mITT population which consisted of all participants who had taken at least one dose of study drug and who had follow-up assessment data on one or more primary or secondary efficacy components.||Percentage of Participants||95% Confidence Interval|Number
679497|NCT01583218|Primary|Percentage of Participants Experiencing Major Bleeding Through Seven Days After Discontinuation of All Study Medication|Percentage of participants experiencing at least one major bleeding adjudicated by a blinded independent CEC between randomization (day 1) and up to seven days after discontinuation of all study medication.|Between randomization and Day 49 (max)|Safety population which consisted of all participants who had taken at least one dose of study drug.||Percentage of Participants||95% Confidence Interval|Number
679498|NCT01583218|Primary|mITT: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, VTE-related Death, or Asymptomatic Proximal DVT, Through Visit 3|mITT: Percentage of participants experiencing either symptomatic DVT, non-fatal PE, VTE related death adjudicated by a blinded independent CEC between randomization and on or before Visit 3 or Day 42 if patient did not have a Visit 3, or a blinded ultrasound core laboratory measuring of asymptomatic proximal DVT between randomization and Day 47. Visit 3 is between day 35-42 after randomization (day 1).|mITT: Between randomization and Day 47 (max)|The mITT population which consisted of all participants who had taken at least one dose of study drug and who had follow-up assessment data on one or more primary or secondary efficacy components.||Percentage of Participants||95% Confidence Interval|Number
679499|NCT01583218|Primary|mITT Cohort 2: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, VTE-related Death, or Asymptomatic Proximal DVT, Through Visit 3|mITT Cohort 2: Percentage of participants experiencing either symptomatic DVT, non-fatal PE, VTE related death adjudicated by a blinded independent CEC between randomization and on or before Visit 3 or Day 42 if patient did not have a Visit 3, or a blinded ultrasound core laboratory measuring of asymptomatic proximal DVT between randomization and Day 47. Visit 3 is between day 35-42 after randomization (day 1).|mITT Cohort 2: Between randomization and Day 47 (max)|"Cohort 2 (encompasses both participants over 75 and participants with baseline D-dimer ≥ 2 x ULN as determined by the local lab) of the mITT population which consisted of all participants who had taken at least one dose of study drug and who had follow-up assessment data on one or more primary or secondary efficacy components."||Percentage of Participants||95% Confidence Interval|Number
679500|NCT01583218|Primary|Modified Intent-to-Treat (mITT) Cohort 1: Percentage of Participants Experiencing the Composite Event of Symptomatic Deep Vein Thrombosis (DVT), Non-fatal Pulmonary Emboli (PE), VTE-related Death, or Asymptomatic Proximal DVT, Through Visit 3|mITT Cohort 1: Percentage of participants experiencing either symptomatic DVT, non-fatal PE, venous thromboembolism (VTE) related death adjudicated by a blinded independent Clinical Events Committee (CEC) between randomization and on or before Visit 3 or Day 42 if patient did not have a Visit 3, or a blinded ultrasound core laboratory measuring of asymptomatic proximal DVT between randomization and Day 47. Visit 3 is between day 35-42 after randomization (day 1).|mITT Cohort 1: Between randomization and Day 47 (max)|Cohort 1 (participants with baseline D-dimer ≥ 2 x upper limit normal (ULN) as determined by the local lab) of the mITT population which consisted of all participants who had taken at least one dose of study drug and who had follow-up assessment data on one or more primary or secondary efficacy components.||Percentage of Participants||95% Confidence Interval|Number
679501|NCT01583101|Primary|The Number of Prompts That Were Responded to|The main outcome of interest is whether or not a prompt was answered (discussed/not discussed).|1 year|||Participants|||Count of Participants
679502|NCT01582971|Primary|Use of Unscheduled Health Service|Measured by Conventional Health Service and Productivity Costs to assess the number of unscheduled times the patient visits an emergency room, urgent care center, and hospitalization.|Week 11|Participant outcome data collected at week 11||unscheduled visits||Standard Deviation|Mean
679503|NCT01582971|Primary|Quality of Life Index (QLI)|The QLI assesses perceived quality of life including health and functioning domain, psychological/spiritual domain, social and economic domain, and family domain. The QLI consists of two sections: one measures respondent's satisfaction with the various domain of life and the other measures the importance of those domains. The satisfaction scores are centered and weighed by the importance scores to obtain the QLI composite score that ranges from 0 to 30 with higher scores representing better outcomes.|Week 5 and week 11|Participant outcome data collected at week 5 and week 11||units on a scale||Standard Error|Least Squares Mean
679504|NCT01582971|Primary|Patient Reported Outcomes Measurement Information System (PROMIS) V 1.0|"PROMIS-Physical functioning subscale contains four items. Score for each item ranging from 1 to 5, yielding a total score ranges from 4 to 20. Raw score is converted to a T-score using PROMIS scoring rules. The T-scores have mean 50 and standard deviation 10 for the general population.
PROMIS-Satisfaction with participation in social roles subscale contains four items. Score for each item ranges from 0 to 4, yielding a total score ranges from 0 to 16. Raw score is converted to a T-score using PROMIS scoring rules. The T-scores have mean 50 and standard deviation 10 for the general population.
Higher scores representing better outcomes in each subscale."|Week 5 and week 11|Participant outcome data collected at week 5 and week 11||units on a scale||Standard Error|Least Squares Mean
679505|NCT01582971|Primary|The M.D. Anderson Symptom Inventory (MDASI)|"The M.D. Anderson Symptom Inventory (MDASI) evaluates severity of 13 symptoms experienced by cancer patients (i.e., pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, difficulty remembering, decreased appetite, drowsiness, dry mouth, sadness, vomiting, numbness/tingling), and the interference of these symptoms with daily life. Summed symptom severity and interference scores were derived from this instrument.
Higher score representing worse outcome."|Week 5 and week 11|Patient outcome data collected at week 5 and week 11||units on a scale||Standard Error|Least Squares Mean
679506|NCT01582945|Primary|Response to Ketamine as Measured by Hamilton Depression Rating Scale -28 Items (HAMD28)|Patients will be assessed with HAMD-28 weekly for the first 8 weeks, then every two weeks for another 8 weeks. Participants were considered as responders if there was a ⩾50% improvement on the HAM-D28.|Weekly for total duration of 4 months|The subjects received a total of 6 infusions, twice a week for three weeks.||participants who met response criteria|||Number
679507|NCT01582880|Secondary|Systemic Safety|Incidence and severity of systemic adverse events during the study (clinical laboratory, adverse events spontaneously reported).|measured at day 1, and week 1, 4, 8, 12, 16, 24, 36, 52|52 year old white male||Incidences|||Number
679508|NCT01582880|Secondary|Ocular Safety|Incidence and severity of ocular adverse events during the study (ophthalmic examination, adverse events spontaneously reported)|measured at day 1, and week 1, 4, 8, 12, 16, 24, 36, 52|52 year old white male||Incidences|||Number
679509|NCT01582880|Secondary|Number of Occurrences of Vitritis (Sterile or Infectious) Ulcers|Number of occurrence of vitritis (sterile or infectious) ulcers. Incidences of ulcers were collected by way of slit lamp photography from time of surgery to final visit.|post op week 52|52 year old white male||occurrences|||Number
679611|NCT01581307|Secondary|Overall Response Rate (ORR)|The overall response: ORR = complete response (CR) + partial response (PR). Rate will be summarized using both point estimates and exact confidence intervals based on the binomial distribution by groups.|Up to 29 months|All participants evaluable at time of analysis||Participants|||Count of Participants
679511|NCT01582880|Primary|Changes in Corneal Thickness at 1 Millimeter|The average carrier graft thickness over the first year of postoperative follow-up. The corneal thickness was measured at each visit using AS-OCT imaging 1 mm away from the KPro stem at 3, 6, 9, and 12 o'clock. The individual corneal thickness measurements (3, 6, 9, and 12 o'clock) where then averaged. The average corneal thickness measurements for week 4, 6, 26, 32 and 52 are reported below.|measured at week 4, 6, 26, 32, 52|52 year old white male patient||micrometer|||Number
679512|NCT01582854|Secondary|Percentage of Participants With a Diagnosis of Dementia|Diagnosis of dementia will be evaluated after 6 and 12 months classified according to International Statistical Classification of Diseases and related Health Problems 10th Revision (ICD-10) [Classification of Mental and Behavioural Disorders, Diagnostic Criteria for Research].|Month 6 and 12|Participants from the Intent-to-treat population, all enrolled participants who received at least one dose of study drug, with data available for analyses at the given time-point.||percentage of participants|||Number
679513|NCT01582854|Secondary|Beck Depression Inventory, Version II (BDI-II) at Months 3, 6 and 12|"The BDI-II is a 21-question multiple-choice self-report inventory for measuring the severity of depression. is composed of items relating to symptoms of depression such as hopelessness and irritability, cognitions such as guilt or feelings of being punished, as well as physical symptoms such as fatigue, weight loss, and lack of interest in sex. Each answer is scored on a scale 0 (best) to 3 (worst). Total scores range from 0 to 63 with higher scores indicating more severe depression.
BDI II scale:
0-13 minimal depression
14-19 mild depression
20-28 moderate depression
29-63 severe depression"|Months 3, 6 and 12|Participants from the Intent-to-treat population, all enrolled participants who received at least one dose of study drug, with data available for analyses at the given time-point.||score on a scale||Standard Deviation|Mean
679514|NCT01582854|Secondary|EuroQol EQ-5D (EQ-5D) General Health at Months 6 and 12|The EuroQoL included a visual analogue scale where the subject marks how they feel at that moment on a scale from 0 (the worst health that can be imagined) to 100 (the best health that can be imagined).|Months 6 and 12|Participants from the Intent-to-treat population, all enrolled participants who received at least one dose of study drug, with data available for analyses at the given time-point.||score on a scale||Standard Deviation|Mean
679515|NCT01582854|Secondary|EuroQol EQ-5D (EQ-5D) at Month 12|EQ-5D is a standardized measure of health status consisting of 5 dimensions: mobility, self -care, usual activities, pain/discomfort and anxiety/depression. The participant rates their level of function in each area using a 5 point scale where 1=no problems (best) to 5=extreme problems (worst). The percentage of participants in each category is reported.|Month 12|Participants from the Intent-to-treat population, all enrolled participants who received at least one dose of study drug, with data available for analyses at the given time-point.||percentage of participants|||Number
679516|NCT01582854|Secondary|EuroQol EQ-5D (EQ-5D) at Month 6|EQ-5D is a standardized measure of health status consisting of 5 dimensions: mobility, self -care, usual activities, pain/discomfort and anxiety/depression. The participant rates their level of function in each area using a 5 point scale where 1=no problems (best) to 5=extreme problems (worst). The percentage of participants in each category is reported.|Month 6|Participants from the Intent-to-treat population, all enrolled participants who received at least one dose of study drug, with data available for analyses at the given time-point.||percentage of participants|||Number
679517|NCT01582854|Secondary|Barthel Index at Months 3 and 6|The Barthel Index consists of 10 items that measure a person's daily functioning, specifically the activities of daily living and mobility. The items include: feeding, transfers (bed to chair and back), grooming, toilet use, bathing, mobility (walking on level surface), going up and down stairs, dressing, continence of bowels and bladder. Each performance item is rated, with a given number of points assigned to each level or ranking. Individual scores are summed for a total possible scores ranging from 0 (worst) to 100 (best) with higher scores indicating more independent daily living.|Months 3 and 6|Participants from the Intent-to-treat population, all enrolled participants who received at least one dose of study drug, with data available for analyses at the given time-point.||score on a scale||Full Range|Median
679518|NCT01582854|Secondary|Change From Baseline in National Institutes of Health Stroke Scale (NIHSS) at End of Infusion Period, Months 3, 6 and 12|The NIHSS is a tool to objectively quantify the impairment caused by a stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 (normal) to 4 (some level of impairment). The individual scores from each item are summed in order to calculate total possible NIHSS score from 0 (best) to 42 (worst). A negative change from Baseline indicates improvement. ANCOVA model was used for analyses that included treatment and pooled centre as factors and Baseline NIHSS score as a covariate.|Baseline and End of Infusion and Months 3, 6 and 12|Participants from the Intent-to-treat population, all enrolled participants who received at least one dose of study drug, with data available for analyses at the given time-point.||score on a scale||Standard Error|Least Squares Mean
679519|NCT01582854|Secondary|Percentage of Participants With a Diagnosis of Dementia|Diagnosis of dementia will be evaluated after 6 and 12 months classified according to International Statistical Classification of Diseases and related Health Problems 10th Revision (ICD-10) [Classification of Mental and Behavioural Disorders, Diagnostic Criteria for Research]. The proportion of participants with dementia was compared between treatments using a Fisher’s exact test.|Month 6|Participants from the Intent-to-treat population, all enrolled participants who received at least one dose of study drug, with data available for analyses at the given time-point.||percentage of participants|||Number
679520|NCT01582854|Secondary|Percentage of ADAS-cog+ Responders at Time Points 3, 6 and 12 Months|Responder was defined as an improvement of 4 or more from baseline on the ADAS-cog+ scale using observed data. The proportion of responders was compared between treatments using a chi-square test.|Baseline and Months 3, 6 and 12|Participants from the Intent-to-treat population, all enrolled participants who received at least one dose of study drug, with data available for analyses at the given time-point.||percentage of responders|||Number
679534|NCT01582490|Secondary|Pain Intensity Assessment at the Time of Hospital Discharge|Subject-reported pain assessment at the time of hospital discharge (assessed an average of 3.11 hours after surgery for the Instillation group and 3.20 hours after surgery for the Infiltration group) on a scale from 0 to 10 where 0 = no pain and 10 = worst possible pain.|At the time of hospital discharge|There were 8 subjects in the Infiltration - EXPAREL efficacy analysis set and 9 subjects in the Instillation - EXPAREL efficacy analysis set.||units on a scale||Standard Deviation|Mean
679521|NCT01582854|Secondary|Change From Baseline in Montreal Cognitive Assessment Scale (MoCA) at End of Infusion Period, Months 3, 6 and 12|"The MoCA is a rapid screening test to assess mild cognitive impairment. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. Time to administer the MoCA is approximately 10 minutes. The total possible score is 0 to 30 points; a score of 26 or above is considered normal. A positive change from Baseline (BL) indicates improvement.
ANCOVA model was used for analyses that included treatment and pooled centres as factors, plus years of education and baseline MoCA score as covariates."|Baseline, End of Infusion and Months 3, 6 and 12|Participants from the Intent-to-treat population, all enrolled participants who received at least one dose of study drug, with data available for analyses at the given time-point.||score on a scale||Standard Error|Least Squares Mean
679522|NCT01582854|Secondary|Change From Baseline in ADAS-cog+ at Month 3 and Month 12|"The ADAS-cog measures cognitive performance by combining the ratings of 11 items. The cognitive domains mainly addressed by ADAS-cog are: memory (short term), language, ability to orientate (reflects memory), construction/planning of simple designs and performance. The extended version of the ADAS-cog (ADAS-cog+) includes 3 additional items: a 2-number cancellation task to test for attention, a delayed recall task to test for memory consolidation and a maze test for executive performance. Each item is scored and then the item scores are totaled. Total scores range from 0 (best) to 90 (worst). Higher scores indicate greater cognitive impairment. A negative change from Baseline indicates improvement.
ANCOVA model was used for analyses that included treatment, pooled centre, and their interaction as factors and Baseline ADAS-cog+ score as a covariate."|Baseline and Months 3 and 12|Intent-to-treat population, all enrolled participants who received at least one dose of study drug, with data available for analysis. Missing individual item scores (where only some item scores missing) imputed with worst possible score.||score on a scale||Standard Error|Least Squares Mean
679523|NCT01582854|Primary|Change From Baseline in Alzheimer's Disease Assessment Scale + Cognitive Subscale Extended Version (ADAS-cog+) at Month 6|"The ADAS-cog measures cognitive performance by combining the ratings of 11 items. The cognitive domains mainly addressed by ADAS-cog are: memory (short term), language, ability to orientate (reflects memory), construction/planning of simple designs and performance. The extended version of the ADAS-cog (ADAS-cog+) includes 3 additional items: a 2-number cancellation task to test for attention, a delayed recall task to test for memory consolidation and a maze test for executive performance. Each item is scored and then the item scores are totaled. Total scores range from 0 (best) to 90 (worst). Higher scores indicate greater cognitive impairment. A negative change from Baseline indicates improvement.
Analysis of Covariance (ANCOVA) model was used for analyses that included treatment, pooled centre, and their interaction as factors and Baseline ADAS-cog+ score as a covariate."|Baseline and Month 6|Intent-to-treat population, all enrolled participants who received at least one dose of study drug, with data available for analysis. Missing individual item scores (where only some item scores missing) imputed with worst possible score and missing total scores (where all item scores missing) imputed by last observation carried forward.||score on a scale||Standard Error|Least Squares Mean
679524|NCT01582789|Primary|Comfortable Wearing Time - Second Intervention|Comfortable Wearing Time. (Participant response in number of hours) Obtained at 2 weeks wear for second intervention at week two visit.|2 Weeks|one drop out at first 2 week follow up||hours||Standard Deviation|Mean
679525|NCT01582789|Primary|Comfortable Wearing Time - First Intervention|Comfortable Wearing Time. (Participant response in number of hours) Obtained at 2 weeks wear for first intervention at week two visit.|2 Weeks|one drop out at first 2 week follow up||hours||Standard Deviation|Mean
679526|NCT01582789|Primary|Comfort - Second Intervention|Participant response of comfort for first intervention of study lenses assessed at 2 weeks. Comfort at insertion, comfort at end of day, comfort at 2 weeks, and overall comfort were rated on subjective response scale. (Scale 0-10, 0=uncomfortable/cannot tolerate, 10=very comfortable/cannot be felt).|2 Weeks|1 subject withdrew from study.||units on a scale||Standard Deviation|Mean
679527|NCT01582789|Primary|Comfort - First Intervention|Participant response of comfort for first intervention of study lenses assessed at 2 weeks. Comfort at insertion, comfort at end of day, comfort at 2 weeks, and overall comfort were rated on subjective response scale. (Scale 0-10, 0=uncomfortable/cannot tolerate, 10=very comfortable/cannot be felt).|2 Weeks|one drop out at first 2 week follow up||units on a scale||Standard Deviation|Mean
679528|NCT01582789|Primary|Comfort - Second Intervention|Comfort - on insertion and overall assessed at baseline for first intervention on a scale 0-10. 0=uncomfortable/cannot tolerate, 10=very comfortable/cannot be felt,|Baseline|one drop out at first 2 week follow up||units on a scale||Standard Deviation|Mean
679529|NCT01582789|Primary|Comfort - First Intervention|Comfort - on insertion and overall assessed at baseline for first intervention on a scale 0-10. 0=uncomfortable/cannot tolerate, 10=very comfortable/cannot be felt,|Baseline|one drop out at first 2 week follow up||units on a scale||Standard Deviation|Mean
679530|NCT01582490|Secondary|Overall Rating of Subject Satisfaction With Postsurgical Pain Control at Day 10|"Subject-reported satisfaction with postsurgical pain control in the categories of extremely dissatisfied, dissatisfied, neither satisfied nor dissatisfied, satisfied, and extremely satisfied."|Day 10 after surgery|There were 8 subjects in the Infiltration - EXPAREL efficacy analysis set and 9 subjects in the Instillation - EXPAREL efficacy analysis set.||participants|||Number
679531|NCT01582490|Secondary|Overall Rating of Subject Satisfaction With Postsurgical Pain Control at Hospital Discharge|"Subject-reported satisfaction with postsurgical pain control in the categories of extremely dissatisfied, dissatisfied, neither satisfied nor dissatisfied, satisfied, and extremely satisfied."|At the time of hospital discharge|There were 8 subjects in the Infiltration - EXPAREL efficacy analysis set and 9 subjects in the Instillation - EXPAREL efficacy analysis set.||participants|||Number
679532|NCT01582490|Secondary|Incidence of Opioid-Related Adverse Events|The incidence of adverse events that were assessed as opioid-related|Through 10 Days Post Surgery|There were 8 subjects in the Infiltration - EXPAREL efficacy analysis set and 9 subjects in the Instillation - EXPAREL efficacy analysis set.||participants|||Number
679533|NCT01582490|Secondary|Time to Hospital Discharge Being Written|The time (hours) to the hospital discharge being written for subjects in each group,|At the time of hospital discharge|There were 8 subjects in the Infiltration - EXPAREL efficacy analysis set and 9 subjects in the Instillation - EXPAREL efficacy analysis set.||hours||Standard Deviation|Mean
679535|NCT01582490|Secondary|Pain Intensity Assessment Upon Waking in the PACU|Subject-reported pain assessment upon waking in the PACU on a scale of 0 to 10 where 0 = no pain and 10 = worst possible pain.|Upon waking in the PACO post surgery|There were 9 subjects in the Infiltration - EXPAREL efficacy analysis set and 8 subjects in the Instillation - EXPAREL efficacy analysis set.||units on a scale||Standard Deviation|Mean
679536|NCT01582490|Secondary|Total Postsurgical Opioid Consumption in the Surgical Center|Total amount of opioids (morphine-equivalent mg) administered postsurgically in each group.|10 days|There were 8 subjects in the Infiltration - EXPAREL efficacy analysis set and 9 subjects in the Instillation - EXPAREL efficacy analysis set.||mg||Standard Deviation|Mean
679537|NCT01582490|Primary|Duration of Analgesia|The primary outcome measure is the duration of analgesia, measured by the time (hours) from the end surgery to the subject's first postsurgical opioid administration.|10 days|Of the 8 subjects in the Infiltration - EXPAREL group (efficacy analysis set), 5 were censored, leaving 3 subjects who were administered an opioid. Of the 9 subjects in the Instillation - EXPAREL group (efficacy analysis set), 7 were censored, leaving 2 subjects who were administered an opioid.||hours|||Number
679538|NCT01582477|Secondary|Overall Rating of Subject Satisfaction With Postsurgical Pain Control|Mean of subject satisfaction offered on a 5-point Likert scale (1 = extremely dissatisfied, 2 = dissatisfied, 3 = neither satisfied nor dissatisfied, 4 = satisfied, 5 = extremely satisfied)|24 hours, 72 hours, and day 10|72 hour reported subject satisfaction at||units on a scale||Standard Deviation|Mean
679539|NCT01582477|Secondary|Incidence of Prespecified Opioid-related Adverse Events|Number of subjects|Until hospital discharge order was written, anticipated at 24 hours.|||Number of subjects|||Number
679540|NCT01582477|Secondary|Total Postsurgical Oxycodone/Acetaminophen Consumption From Hospital Discharge Through Hour 96.|Number of pills|48, 72, 96 hours, and 10 days|96 hour measurement given||Number of tablets||Standard Deviation|Mean
679541|NCT01582477|Secondary|Physician/Healthcare Professional Assessed Postsurgical Pain|11-point NRS (0-10, 0=no pain, 10=worst possible pain)|1, 2, 6, 12, 24 hours after TAP|24 hour NRS is reported||units on a scale||Standard Deviation|Mean
679542|NCT01582477|Secondary|Subject Reported Postsurgical Pain|11-point numeric rating scale (NRS) (0-10, where 0=no pain, 10=worst possible pain)|1, 2, 6, 12, 24, 48, 72, 96 hours and 10 days after TAP|Data shown are from the 72-hour time point||units on a scale||Standard Deviation|Mean
679543|NCT01582477|Primary|The Duration of Abdominal Analgesia From Infiltration Into the TAP||First postsurgical administration of an opioid|Per protocol||hours||Inter-Quartile Range|Median
679544|NCT01582308|Secondary|Pharmacokinetic Analysis: Time to the Peak Plasma Drug Concentration (Tmax)|Measurement of the time to the peak plasma drug concentration following the Day 5 morning dose.|Predose (0 hours) and 0.5, 1, 2, 4, 8, 12, 13 (vildagliptin 50 mg BID only), 14 (vildagliptin 50 mg BID only), 16, 20, 24, 36, 48 and 96 hours after the morning dose on Day 5|All participants who had at least at least one measurement.||hr||Full Range|Median
679545|NCT01582308|Secondary|Pharmacokinetic Analysis: Peak Plasma Drug Concentration (Cmax)|Measurement of the peak plasma drug concentration following the Day 5 morning dose.|Predose (0 hours) and 0.5, 1, 2, 4, 8, 12, 13 (vildagliptin 50 mg BID only), 14 (vildagliptin 50 mg BID only), 16, 20, 24, 36, 48 and 96 hours after the morning dose on Day 5|All participants who had at least at least one measurement.||nM||Geometric Coefficient of Variation|Geometric Mean
679546|NCT01582308|Secondary|Pharmacokinetic Analysis: Area Under the Curve 0-12 Hours (AUC 0-12hr) for Vildagliptin 50 mg BID|AUC 0-12hr is the area under the plasma drug concentration-time curve calculated for the 12 hour interval after the Day 5 morning dose for the vildagliptin 50 mg BID dose only.|Predose (0 hours) and 0.5, 1, 2, 4, 8 and 12 hours after the morning dose on Day 5|All participants who had at least at least one measurement. This outcome measure is for the vildagliptin 50 mg BID dose only; therefore, results are only presented for vildagliptin 50 mg BID dose.||nM*hr||Geometric Coefficient of Variation|Geometric Mean
679547|NCT01582308|Secondary|Pharmacokinetic Analysis: Area Under the Curve 0-24 Hours (AUC 0-24hr)|AUC 0-24hr is the area under the plasma drug concentration-time curve calculated for the 24 hour interval after the Day 5 morning dose.|Predose (0 Hours) and 0.5, 1, 2, 4, 8, 12, 13 (vildagliptin 50 mg BID only), 14 (vildagliptin 50 mg BID only), 16, 20 and 24 hours after the morning dose on Day 5|All participants who had at least at least one measurement.||nM*hr||Geometric Coefficient of Variation|Geometric Mean
679548|NCT01582308|Primary|Percent Inhibition of Dipeptidyl Peptidase IV (DPP-4) Activity at Trough|Percent inhibition of DPP-4 activity at 24 hours after the Day 5 morning dose (i.e., at trough) was determined by analysis of blood samples collected from the study participants.|24 hours following the final morning dose on Day 5|All participants who had at least at least one measurement.||Percent inhibition||95% Confidence Interval|Least Squares Mean
679549|NCT01582282|Primary|Triglyceride Change From Baseline|Change is defined as Post-Baseline minus Baseline|12 weeks|Analysis of Covariance of Cholesterol Measures Intent-to-Treat||mg/dL||Standard Error|Mean
679550|NCT01582282|Primary|Total Cholesterol Change From Baseline|Change is defined as Post-Baseline minus Baseline|12 weeks|Analysis of Covariance of Cholesterol Measures Intent-to-Treat||mg/dL||Standard Error|Mean
679551|NCT01582282|Primary|Change From Baseline in Fasting LDL Cholesterol|Change is defined as Post-Baseline minus Baseline|12 weeks|The LDL cholesterol values for two subjects at week 12 were unreportable.||mg/dL||Standard Error|Mean
679552|NCT01582282|Primary|Change From Baseline in Fasting HDL Cholesterol|Change is defined as Post-Baseline minus Baseline|12 weeks|Analysis of Covariance of Cholesterol Measures Intent-to-Treat||mg/dL||Standard Error|Mean
679553|NCT01582282|Primary|Change From Baseline in Fasting HbA1c|Change is defined as Post-Baseline minus Baseline|12 weeks|||percentage of total hemoglobin||Standard Error|Mean
679554|NCT01582282|Primary|Change From Baseline in Fasting Glucose|Change from Baseline is defined as the Post-Baseline value subtracted from the Baseline value|12 weeks|Intent-to-Treat||mg/dL||Standard Error|Mean
679555|NCT01582243|Secondary|The Percentage of Patients Achieving the Two Glycemic Goals After 12- and 24-week Treatment|Patients reaching glycemic goal of HbA1c ≤ 6.5% and ≤ 7.0% at week 12 and 24 will be calculated respectively.|week 12, week 24|Intent to Treat (ITT) population: all enrolled patients who took at least one tablet of vildagliptin plus metformin 50/500 mg, and had Baseline and at least one post treatment evaluation for efficacy measurement||percentage of participants|||Number
686352|NCT01490866|Secondary|Time To Progression (TTP)|Defined as the time after a disease is diagnosed (or treated) until worsening of the disease.|every 8 weeks, assessed approximately up to 24 months|||months||95% Confidence Interval|Median
679556|NCT01582243|Secondary|Mean Change From Baseline in Mean Amplitude of Glycemic Excursions (MAGE) Detected by Continuous Glucose Monitoring System (CGMS) After 24-week|Mean amplitude of glycemic excursions (MAGE), which was used to quantify major swings of glycaemia and assess intra-day glycemic variability, was measured by inserting continuous glucose monitoring system (CGMS) in patients for 72 consecutive hours before Day 1 (Visit 2) and Week 24 (Visit 5). In order to unify the different initial time and time of completion in each patient, only the data recorded from Day 2 00:00 to Day 3 23:59 with total 48 hours were analyzed.|Baseline, week 24|Intent to Treat (ITT) population: all enrolled patients who took at least one tablet of vildagliptin plus metformin 50/500 mg, and had Baseline and at least one post treatment evaluation for efficacy measurement||mg/dL||Standard Deviation|Mean
679557|NCT01582243|Secondary|Mean Change From Baseline in Postprandial Plasma Glucose(PPG) at Week 12 and 24|PPG analysis will be performed on a blood sample obtained by study personnel.|Baseline, week, week 24|Intent to Treat (ITT) population: all enrolled patients who took at least one tablet of vildagliptin plus metformin 50/500 mg, and had Baseline and at least one post treatment evaluation for efficacy measurement||mg/dL||Standard Deviation|Mean
679558|NCT01582243|Secondary|Mean Change From Baseline in Fasting Plasma Glucose(FPG) at Week 12 and 24|FPG analysis will be performed on a blood sample obtained by study personnel.|Baseline, week 12, week 24|Intent to Treat (ITT) population: all enrolled patients who took at least one tablet of vildagliptin plus metformin 50/500 mg, and had Baseline and at least one post treatment evaluation for efficacy measurement||mg/dL||Standard Deviation|Mean
679559|NCT01582243|Secondary|Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12|HbA1c analysis will be performed on a blood sample obtained by study personnel.|Baseline, week 12|Intent to Treat (ITT) population: all enrolled patients who took at least one tablet of vildagliptin plus metformin 50/500 mg, and had Baseline and at least one post treatment evaluation for efficacy measurement||percentage||Standard Deviation|Mean
679560|NCT01582243|Primary|Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|HbA1c analysis will be performed on a blood sample obtained by study personnel.|Baseline, Week 24|Intent to Treat (ITT) population: all enrolled patients who took at least one tablet of vildagliptin plus metformin 50/500 mg, and had Baseline and at least one post treatment evaluation for efficacy measurement||percentage||Standard Deviation|Mean
679561|NCT01582178|Primary|Cecal Intubation Time|= time between introduction of the colonoscope into the anus and reaching the cecum.|1-30|||minute||Standard Deviation|Mean
679562|NCT01582178|Secondary|Patient Comfort During Insertion Phase of the Colonoscopy||3 months||||||
679563|NCT01582178|Primary|Cecal Intubation Time||3 months||||||
679564|NCT01582139|Secondary|Time in Range|Percent time spent within target (70-180 mg/dL) range.|26 hours (x2 admissions)|Twelve subjects completed the study. The first two subjects were excluded from the analysis because of protocol violations during the exercise session (the intensity chosen was very high: rating of perceived exertion of 9 out of 10 instead of rating of perceived exertion of 9 out of 20). Results from the 10 remaining subjects are presented below.||percentage of time spent in range||Standard Error|Mean
679565|NCT01582139|Secondary|Average Glucose Drop|Average glucose drops at specific time points after the onset of exercise; defined as the difference between plasma glucose at onset of exercise and the glucose values reached at 40 and 60 min post onset of exercise.|26 hours (2x admissions)|The first two subjects were excluded from the analysis because of protocol violations during the exercise session (the intensity chosen was very high: rating of perceived exertion of 9 out of 10 instead of rating of perceived exertion of 9 out of 20). Results from the 10 remaining subjects are presented.||mg/dL||Standard Deviation|Mean
679566|NCT01582139|Secondary|Low Blood Glucose Index|"A measure of the risk of hypoglycemia. It quantifies the frequency and the extent of low BG readings.
A LBGI < 2.5 is associated with a low-risk of hypoglycemia, LBGI 2.5-5 is associated with a moderate risk of hypoglycemia, and LBGI > 5 is associated with a high-risk of hypoglycemia."|26 hours (x2 admissions)|Twelve subjects completed the study. The first two subjects were excluded from the analysis because of protocol violations during the exercise session (the intensity chosen was very high: rating of perceived exertion of 9 out of 10 instead of rating of perceived exertion of 9 out of 20). Results from the 10 remaining subjects are presented below.||index score||Standard Error|Mean
679567|NCT01582139|Primary|Hypoglycemic Events|Plasma glucose based number of hypoglycemic events, defined as consecutive plasma readings below 70mg/dl to measure the capacity of the system to protect patients against the risk of hypoglycemia. Two events separated by only one Yellow Springs Instrument (YSI) value over 70 are considered to form a single event.|26 hours (x2 admissions)|Twelve subjects completed the study. The first two subjects were excluded from the analysis because of protocol violations during the exercise session (the intensity chosen was very high: rating of perceived exertion of 9 out of 10 instead of rating of perceived exertion of 9 out of 20). Results from the 10 remaining subjects are presented below.||hypoglycemic events|||Number
679568|NCT01582100|Primary|Incidence of Nausea in Patients With GERD|number of events of nausea with or without vomiting in patients with GERD in 4 weeks|4 weeks||||||
679569|NCT01582009|Secondary|6-month Overall Survival Rate|6-month overall survival rate|The time from registration up to 3 years|All treated and eligible patients. Assessed using Kaplan Meier and Proportional Hazards.||percentage of participants||95% Confidence Interval|Number
679570|NCT01582009|Secondary|Median Progression Free Survival|Median progression free survival. Assessed using Kaplan Meier and Proportional Hazards.|The time from registration up to 3 years|All treated and eligible patients||months||95% Confidence Interval|Median
679571|NCT01582009|Secondary|Number of Participants With an Adverse Event.|Number of participants with an adverse event. Please refer to the adverse event reporting for more detail.|The time from registration up to 3 years|All treated and eligible patients||Participants|||Count of Participants
679572|NCT01582009|Primary|Number of Participants With Clinical Response|Number of participants with clinical response. Response will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors ver 1.0 Committee [JNCI 92(3):205-216, 2000]. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST ver. 1.0 criteria.|The time from registration up to 3 years|All treated and eligible patients||Participants|||Count of Participants
679606|NCT01581437|Secondary|Number of Participants With Successful Use of 64 Pole Basket Catheter at Non-University of California San Diego Electrophysiology Labs|To determine if the 64 pole basket catheter will be successfully used to gather information on Atrial Fibrillation drivers.|30 min|||participants|||Number
679573|NCT01582009|Primary|Progression-free Survival (PFS)|6 month PFS survival rate. Calculated as the total number of failures (deaths or progression) divided by the total follow-up or exposure time of patients on study. Assessed using Kaplan Meier and Proportional Hazards.|The time from registration to documentation of disease progression up to 3 years|All treated and eligible patients||percentage of participants||95% Confidence Interval|Number
679574|NCT01581931|Primary|Maximum Concentration (Cmax) of Metformin|Cmax represents the maximum concentration of metformin in plasma. Note, the geometric mean is actually an adjusted geometric mean.|0:20, 0:40, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 24, 34, 48, 72 hours|Treated set - all subjects taking at least 1 dose of trial medication||ng/mL||Geometric Coefficient of Variation|Geometric Mean
679575|NCT01581931|Primary|Area Under Curve From 0 to tz Hours (AUC0-tz) of Metformin|AUC0-tz represents the area under the concentration curve of metformin in plasma from 0 to the time of the last quantifiable plasma contentration of the analyte. Note, the geometric mean is actually an adjusted geometric mean.|0:20, 0:40, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 24, 34, 48, 72 hours|Treated set - all subjects taking at least 1 dose of trial medication||ng·h/mL||Geometric Coefficient of Variation|Geometric Mean
679576|NCT01581931|Secondary|Terminal Half-life t1/2 of Metformin|The terminal half-life of metformin in plasma is denoted by t1/2.|0:20, 0:40, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 24, 34, 48, 72 hours|Treated set - all subjects taking at least 1 dose of trial medication||Hours||Geometric Coefficient of Variation|Geometric Mean
679577|NCT01581931|Secondary|Time to Maximum Concentration (Tmax) of Metformin|Time from dosing to the maximum concentration of metformin in plasma.|0:20, 0:40, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 24, 34, 48, 72 hours|Treated set - all subjects taking at least 1 dose of trial medication||Hours||Full Range|Median
679578|NCT01581931|Secondary|Area Under Curve From 0 to Infinity Hours (AUC0-infty) of Metformin|AUC0-infty represents the area under the concentration curve of metformin in plasma from time 0 extrapolated to infinity. Note, the geometric mean is actually an adjusted geometric mean.|0:20, 0:40, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 24, 34, 48, 72 hours|Treated set - all subjects taking at least 1 dose of trial medication||ng·h/mL||Geometric Coefficient of Variation|Geometric Mean
679579|NCT01581684|Primary|Clinically Relevant Abnormalities for Physical Examinations, Vital Signs, ECG, Laboratory Tests|Clinically relevant abnormalities for physical examinations, vital signs (blood pressure, pulse rate, oral body temperature, orthostasis test), 12-lead electrocardiogram (ECG) and clinical laboratory tests. Clinically relevant abnormalities are reported by the investigator as adverse events (AEs).|From drug administration until end of trial examination, up to 13 days|Treated set||participants|||Number
679580|NCT01581684|Primary|Number of Participants With Drug Related AEs|Number of participants with drug related adverse events (AEs)|From drug administration until end of trial examination, up to 13 days|Treated set which included all subjects who were administered trial medication and were documented to have taken the dose of investigational treatment||participants|||Number
679581|NCT01581684|Secondary|Amount of Analyte Eliminated in Urine From 0h to 4h (Ae0-4)|Amount of analyte (BI 411034) eliminated in urine from the time point 0h to time point 4h.|2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration|PK analysis set||nmol||Geometric Coefficient of Variation|Geometric Mean
679582|NCT01581684|Secondary|Area Under the Curve From 0 Extrapolated to Infinity (AUC0-infinity)|Area under the concentration-time curve of the analyte (BI 411034) in plasma over the time interval from 0 extrapolated to infinity|2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration|PK analysis set||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
679583|NCT01581684|Secondary|Time to Maximum Measured Concentration (Tmax)|Time from dosing to maximum measured concentration|2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration|PK analysis set||h||Full Range|Median
679584|NCT01581684|Secondary|Maximum Measured Concentration (Cmax )|Maximum measured concentration of the analyte (BI 411034) in plasma|2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration|PK analysis set which included all subjects who were administered trial medication and were documented to have taken the dose of investigational treatment and who provided at least one observation for at least one pharmacokinetic (PK) endpoint without important protocol violations relevant to the evaluation of PK||nmol/L||Geometric Coefficient of Variation|Geometric Mean
679585|NCT01581658|Primary|Maximum Concentration|Maximum concentration of the analyte in plasma|Predose and 20 minutes (min), 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 24h, 36h 48h, 72h and 96h after drug administration|Treated patients||nmol/L||Geometric Coefficient of Variation|Geometric Mean
679586|NCT01581658|Primary|Area Under the Concentration Time Curve of the Analyte in Plasma|Area under the concentration time curve of the analyte in plasma over the time interval from 0 to infinity|Predose and 20 minutes (min), 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 24h, 36h 48h, 72h and 96h after drug administration|Treated patients||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
679587|NCT01581658|Primary|Change From Baseline in Total Urinary Glucose Excretion (UGE)|change from baseline in total urinary glucose excretion (UGE) to 24 hours|baseline and 24 hours|Treated patients who had complete urine sample (baseline and 24 hours) for analyses.||mg||95% Confidence Interval|Least Squares Mean
679588|NCT01581619|Secondary|Breast Cosmesis|"Breast Cosmesis was assessed using a cosmetic scoring system. The data shown represent the latest assessment for each participant at the time of analysis. Cosmetic changes were assessed using the following the following criteria.
Excellent: Little or no observable change
Good: Minimal but identifiable changes
Fair: Significant results of radiotherapy noted
Poor: Severe normal tissue sequelae"|End of treatment, 4-9 weeks post treatment, every six months for first 5 years, then annually for 5 years|The one participant that withdrew consent before outcomes were met was excluded from the analysis.||Participants|||Count of Participants
679589|NCT01581619|Secondary|Distant Control Rates|The number of participants that achieved distant control. Distant control is defined as a lack of distant metastasis following the completion of treatment. Distant metastasis refers to the development of disease at distant body sites like the lung, liver, bone, or brain.|2 years|The one participant that withdrew consent before the outcome was met was excluded from the analysis||Participants|||Count of Participants
679590|NCT01581619|Secondary|Local Control Rates|The local control rates (analyzed separately for patients with DCIS and invasive cancer). Local control is defined as lack of recurrence in the treated breast and ipsilateral axillary, supraclavicular and internal mammary lymph nodes. Recurrence is defined as the regrowth of tumor cells left following initial therapy and/or the development of new primary tumors unrelated to the original one. DCIS stands for 'Ductal Carcinoma In Situ'.|2 years|The one participant that withdrew consent before the outcome was met was excluded from the analysis||Participants|||Count of Participants
679591|NCT01581619|Primary|Safety of External-beam PBI Utilizing 40Gy in Ten Daily Fractions Over Two Weeks|"The safety of external-beam PBI in selected stages 0 and I female breast cancer patients utilizing 40 Gy in ten daily fractions over two weeks. The study will be deemed too toxic if >10% of enrolled patients have at least one of the following outcomes within 24 months of completion of PBI.
Grade 3 or 4 skin/subcutaneous or pulmonary toxicity.
The development of clinical fat necrosis.
The development of rib fracture on the ipsilateral treated side, detected either clinically and/or radiographically.
The data is shown as the number of participants that experienced each of the specific toxicities."|2 years|Analysis does not include the one participant who withdrew consent before outcome was met.||participants|||Number
679592|NCT01581541|Secondary|Clearance|Clearance was calculated from drug dose and AUC(0-∞).|Before the start of infusion, 30 minutes after the start of infusion, 5 minutes before completion of infusion, and at 1.5, 2, 3, 4, 7, 10, and 24 hours after the start of infusion on day 1 during cycle 1.|||L/h/kg||Standard Deviation|Mean
679593|NCT01581541|Secondary|Urinary Excretion (%)|Elimination of the drug was investigated by analysis of an aliquot of the total urine collected in 24 h.|Every void post-treatment on day 1 of cycle 1|||percent of dose recovered||Standard Deviation|Mean
679594|NCT01581541|Secondary|Area Under the Concentration-Time Curve From Time 0 to Infinity [AUC(0-∞)]|Area Under the Concentration-Time Curve From Time 0 to Infinity was estimated by trapezoidal rule calculations|Before the start of infusion, 30 minutes after the start of infusion, 5 minutes before completion of infusion, and at 1.5, 2, 3, 4, 7, 10, and 24 hours after the start of infusion on day 1 during cycle 1.|||µM*min||Standard Deviation|Mean
679595|NCT01581541|Secondary|Area Under the Concentration-Time Curve From Time 0 to 24 Hours [AUC(0-24)]|Area Under the Concentration-Time Curve From Time 0 to 24 Hours was estimated by trapezoidal rule calculations|Before the start of infusion, 30 minutes after the start of infusion, 5 minutes before completion of infusion, and at 1.5, 2, 3, 4, 7, 10, and 24 hours after the start of infusion on day 1 during cycle 1.|||µM*min||Standard Deviation|Mean
679596|NCT01581541|Secondary|Terminal Half-life (T1/2)|The terminal half-life (t1/2) was derived from the plasma concentration vs. time data.|Before the start of infusion, 30 minutes after the start of infusion, 5 minutes before completion of infusion, and at 1.5, 2, 3, 4, 7, 10, and 24 hours after the start of infusion on day 1 during cycle 1.|||hours||Standard Deviation|Mean
679597|NCT01581541|Secondary|Maximum Observed Plasma Concentration (Cmax)|The maximum concentration (Cmax) was determined by visual inspection of the concentration versus time data.|Before the start of infusion, 30 minutes after the start of infusion, 5 minutes before completion of infusion, and at 1.5, 2, 3, 4, 7, 10, and 24 hours after the start of infusion on day 1 during cycle 1.|||µM||Standard Deviation|Mean
679598|NCT01581541|Secondary|Number of Days on Treatment||up to 126 days|All participants who continued further treatment and did not start an alternative treatment were considered evaluable for response.||days||Full Range|Median
679599|NCT01581541|Secondary|Number of Participants According to Best Response Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1)|Number of Participants According to Best Response Per Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by computed tomography (CT): Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (POD); POD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions.|Baseline and every 6 weeks up to 18 weeks|All participants who continued further treatment and did not start an alternative treatment were considered evaluable for response.||Participants|||Count of Participants
679600|NCT01581541|Primary|Maximum Tolerated Dose (MTD) of PU-H71|The MTD is the dose level at which no more than 1 of 6 patients experience DLT during the first cycle of treatment, and the dose below that at which at least 2 (of ≤ 6) patients have DLT as a result of the drug.|Cycle 1 (21 days)|||mg/m^2|||Number
679601|NCT01581541|Primary|Number of Participants With Adverse Events Possibly, Probably, or Definitely Related to Study Drug|Severity of adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Grade 1 Mild adverse event (AE), Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, and Grade 5 Death related to AE.|3 years and two months and 11 days|||Participants|||Count of Participants
679602|NCT01581541|Primary|Number of Participants With Cycle 1 Dose-limiting Toxicities (DLTs)|A DLT was defined as an adverse event that occurred during cycle 1, was thought to be related to study drug administration, and met one of the following criteria: grade ≥ 3 non-hematologic toxicities (except diarrhea, nausea, vomiting without maximal supportive therapy; alopecia), grade 4 hematologic toxicities (except lymphopenia), and grade 2 ocular toxicity that did not resolve to ≤ grade 1 within 2 weeks. Occurrence of a DLT resulted in a dose reduction following resolution to grade ≤ 2. No more than 2 dose reductions were allowed per patient on study.|Cycle 1 (21 days)|||Participants|||Count of Participants
679603|NCT01581437|Secondary|Percentage of All Patients Who Underwent Ablation of Rotor/Focal Sources of Atrial Fibrillation|percentage of all patients who had ablation perfornmed|1 year|all patients participating undergo mapping using the 64 pole basket catheter||percentage of all patients undergoing ab|||Number
679604|NCT01581437|Secondary|Single-procedure Freedom From Atrial Fibrillation|percentage of patients without prior ablation|one year|percentage of patients who underwent mapping with 64 pole basket catheter||percentage of patients with no prior abl|||Number
679605|NCT01581437|Secondary|Mean Time to Recurrence of Atrial Fibrillation|mean time to recurrence of atrial fibrillation|1 year|patients participating undergo mapping using the 64 pole basket catheter||days||Full Range|Mean
679607|NCT01581437|Primary|Average Number of Rotors/Focal Drivers in Diverse Locations||30 minutes|||rotor/focal drivers||Standard Deviation|Mean
679612|NCT01581307|Secondary|Rate of Progression Free Survival (PFS)|PFS defined as the time from study enrollment to progression in the liver by modified Response Evaluation Criteria in Solid Tumors (RECIST) or death, whichever occurs first will be analyzed and summarized with the survival probabilities over time using Kaplan-Meier method. Confidence intervals for the median PFS rates at different time points will be constructed when appropriate.|Up to 29 months|All participants evaluable at time of analysis||Participants|||Count of Participants
679613|NCT01581307|Primary|Median Overall Survival (OS)|OS, defined as the time from study enrollment to death from any cause, will be analyzed and summarized with the survival probabilities over time using Kaplan-Meier method. Confidence intervals for the median OS rates at different time points will be constructed when appropriate.|Up to 29 months|All participants evaluable at time of analysis||months||95% Confidence Interval|Median
679614|NCT01581281|Secondary|Occurrence of Treatment Emergent Serious Adverse Events|To determine if amitriptyline or topiramate differ from placebo on the occurrence of treatment emergent serious adverse events.|24 weeks of the trial|||serious adverse events|||Number
679615|NCT01581281|Secondary|Tolerability, as Indicated by the Number (Percentage) of Participants That Completed the 24-week Treatment Phase|To assess tolerability, the percentage of subjects who complete the entire 24-week treatment period will be estimated in each of the three groups.|24 weeks|Tolerability was assessed for all participants included in the primary analysis. Of those randomized, 33 were not included in the primary analysis due to early trial closure.||Participants|||Count of Participants
679616|NCT01581281|Secondary|Change in Number of Headache Days|"This outcomes measure examines whether the rate of absolute number of headache days, per 28 day period, differs between treatment groups over time. This was assessed longitudinally based on the actual number of headache days from the 28 days prior to randomization to the last 28 days of this 24 week trial. The change in absolute headache days was compared between:
Amitriptyline vs. placebo
Topiramate vs. placebo
Amitriptyline vs. Topiramate"|4 week baseline period and last 4 weeks of the 24-week trial|The analysis population included all participants who had observed end-point data: 101 in the topiramate group, 59 in the placebo group, and104 in the amitriptyline group.||days||Standard Deviation|Mean
679617|NCT01581281|Secondary|Change in Absolute Headache Disability Score on PedMIDAS|"The PedMIDAS scale which evaluated the impact of headaches in school, home, play, and social activities, is comprised of six items that pertain to days missed in various activities over the past 90 days. Questions were answered by the youth in consultation with their parents and reviewed by study staff. The PedMIDAS scale was administered at baseline (covering the three months prior to enrollment) and at the 24-week endpoint visit (the end of the maintenance period, covering three months of enrollment). A total PedMIDAS score (sum of items 1-6) was used in this trial. Scores range from 0-240; with a score of 0-10 indicating no disability, 11-30 mild disability, 31-50 moderate disability, and more than 50 severe disability in daily activities. The main outcome measure for this comparison will be the difference in the baseline and endpoint (24 week) PedMIDAS total scores for:
Amitriptyline vs. Placebo
Topiramate vs. Placebo
Amitriptyline vs Topiramate"|baseline and 24 week endpoint|||units on a scale||Standard Deviation|Mean
679618|NCT01581281|Primary|Number (Percentage) of Participants Reporting a ≥ 50% Reduction in Headache Days|"The primary endpoint was a ≥ 50% reduction in headache frequency from the 28 days (4 weeks) baseline period prior to randomization to the last 28 days (4 weeks) of the trial. Headache frequency was defined as the number of days with headache for a given four week 28 day (4 week) period. A headache day was defined as any day during which any headache occurs within a 24 hour period, starting and ending at midnight.
For each participant, the primary endpoint involved a determination of whether a 50% or greater reduction in headache frequency was observed during the last 4 weeks of active treatment as compared with the headache frequency during the 4-week baseline period. Results were compared across the three treatment groups."|4 week baseline period and last 4 weeks of the 24-week trial|The primary endpoint involved a determination of whether a 50% or greater reduction in headache frequency was observed during the last 4 weeks of active treatment as compared with the headache frequency during the 4-week baseline period between the participants receiving amitriptyline and participants receiving placebo.||Participants|||Count of Participants
679619|NCT01581021|Secondary|Mobilization and Pain Survey|Using a numeric rating scale (0 = no pain and 10 = unbearable pain), patients were asked to estimate their experienced pain while at rest and when mobile by specifying a number on the scale.|24 months post-operative|||units on a scale||Standard Deviation|Mean
679620|NCT01581021|Primary|Scoliosis Research Society-30 Survey|Participants were administered a validated survey for evaluating patient quality of life and satisfaction with treatment. Total SRS-30 scores (max = 150) and the domains: function (max = 35), pain (max = 30), self-image (max = 45), mental health (max = 25), and satisfaction with management (max = 15) were analyzed on a scale from 1 (worst) to 5 (best). The mean was obtained by dividing maximum possible score by the number of questions answered.|24 months post-operative|||units on a scale||Standard Deviation|Mean
679621|NCT01581021|Primary|Rotation|The degree to which the spinal column is rotated from its normal position will be assessed.|24 months post-operative|||degree||Standard Deviation|Mean
679622|NCT01581021|Primary|Main Thoracic Cobb|X-rays measures the degree of curve in the thoracic spine.|24 months post-operative|||Degree||Standard Deviation|Mean
679623|NCT01581008|Secondary|Adherence to the Study Protocol (CASA Arm Only)|"We will calculate percentage adherence to pre-specified tasks on the intervention protocol, such as:
how often is depression addressed with a treatment plan?
how often are care team recommendations placed as orders in the medical record?
how often are orders completed?"|3 months|"A variety of process information was analyzed. Please see Bekelman DB et al, Feasibility and acceptability of a collaborative care intervention to improve symptoms and quality of life in chronic heart failure: mixed methods pilot trial Journal of Palliative Medicine 2014, PMID 14329424 for details."||%in arm severe target symptoms addressed|||Number
679624|NCT01581008|Secondary|Participation Rates|We will use a CONSORT diagram to display participant flow, and determine how many of those who were approached enrolled in the trial.|7 months|The total population approached was 72 people. 31 consented to be randomized for a participate rate of 43%. Of these, one was a screen failure, and 17 and 13 were randomized to arm 1 and arm 2 respectively.||participants|||Number
679625|NCT01581008|Secondary|Preliminary Estimate of Intervention Effect (Summative Evaluation)|Pre-post-measurement of outcomes using KCCQ, ESAS, PHQ-9, GAD-7, adoption of orders by PCPs, Spiritual well-being|3 months||||||
679626|NCT01581008|Primary|Cohort Retention|Cohort retention will be determined by examining the proportion of patients who complete the final study visit (at 3-month follow-up) over the total number of patients enrolled in the study (including deceased and lost-to-follow-up). Our goal is an 80% retention rate for this pilot study.|3 months|||participants|||Number
679627|NCT01580995|Primary|Change in HCV RNA Viral Load|Measure change in HCV RNA viral load in treatment group as compared with placebo|Baseline, 12 weeks|patients who completed 12 weeks of follow up||log(IU/mL)||Standard Deviation|Mean
679628|NCT01580904|Secondary|LDL Cholesterol|average LDL cholesterol over 24 weeks|Up to 24 weeks|||mg/dL||Standard Deviation|Mean
679629|NCT01580904|Secondary|Total Cholesterol|average total cholesterol over 24 weeks|Up to 24 weeks|||mg/dL||Standard Deviation|Mean
679630|NCT01580904|Primary|Fasting Glycemia|average fasting glycemia over 24 weeks|Up to 24 weeks|||mg/dL||Standard Deviation|Mean
679631|NCT01580904|Primary|Glycated Hemoglobin|average glycated hemoglobin over 24 weeks|Up to 24 weeks|Data are glycated hemoglobin means of all patients per group.||percent (%)||Standard Deviation|Mean
679632|NCT01580618|Secondary|Duration of Hospital Stay From the Time of Initiation of Infusion Therapy for the Loculated Effusion|This measures the number of hospital days for each participant after they were started on their infusion therapy.|30 days|||days||Standard Deviation|Mean
679633|NCT01580618|Secondary|Percentage of Patients Able to Undergo Pleurodesis to Prevent Recurrent Pleural Effusion.||30 days|||percentage of participants|||Number
679634|NCT01580618|Secondary|Percentage of Patients Who Fail Initial Therapy (TNK or Saline) Who at the Request of the Hospital-based Doctor Are Then Switched to the Other Arm/Group AND Who Then Achieve Satisfactory Drainage (Saline or TNK) Therapy.|Only one patient who was on normal saline arm/group was switched (by request of the referring hospital-based doctor) to TNKase, but did not have complete clearing of their effusion. No patient in the TNKase arm/group was switched to normal saline. Therefore, we have removed the TNKase arm/group from this portion of the analysis since there are no participants in this group to analyze this outcome measure.|3-5 days|||percentage of participants|||Number
679635|NCT01580618|Primary|Percentage of Patients With Hemorrhagic Complications Associated With Catheter Drainage|This is the percentage of patients in each arm of the study (Normal saline or TNKase) who suffered a hemorrhagic complication directly associated with instillation of normal saline or TNKase|3-5 days|||percentage of participants|||Number
679636|NCT01580618|Primary|Percentage of Patients Achieving Complete or Near Complete Drainage of Loculated Pleural Effusion as Determined From Chest Radiography After Three Days or Five Days of Intrapleural Therapy.||3-5 days|||percentage of participants|||Number
679637|NCT01580592|Secondary|Number of Participants With Abnormal Physical Examinations, Laboratory Assessments, Vital Signs, and Adverse Events|This includes physical examination, routine safety laboratory assessments, vital signs and adverse event reporting|day 70|||participants|||Number
679638|NCT01580592|Primary|Change in Critical Temperature Thresholds (CTT) From Baseline to Day 70 After Treatment With Omalizumab Compared to Placebo|The primary efficacy outcome was the change in trigger thresholds from baseline to week ten using TempTest® to assess critical temperature thresholds in °C.|day 70|female and male||degree celcius||Standard Deviation|Mean
679639|NCT01580488|Secondary|Change in Skin Thickness From Baseline to Day 22|Change in skin thickness – echo-poor band measured by ultrasound from baseline to end of treatment|Baseline to Day 22|||millimeters||Standard Deviation|Mean
679640|NCT01580488|Secondary|Change in Lesion Thickness From Baseline to Day 22|Change in total skin thickness measured by ultrasound from baseline to end of treatment|Baseline to Day 22|||millimeters||Standard Deviation|Mean
679641|NCT01580488|Secondary|Change in Scaling From Baseline to Day 22|Investigator’s rating of the clinical appearance of scaling . Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to Day 22|||units on a scale||Standard Deviation|Mean
679642|NCT01580488|Secondary|Change in Infiltration From Baseline to Day 22|Investigator’s rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to Day 22|||units on a scale||Standard Deviation|Mean
679643|NCT01580488|Secondary|Change in Erythema From Baseline to Day 22|Investigator’s rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to Day 22|||units on a scale||Standard Deviation|Mean
679644|NCT01580488|Primary|Change in the Total Clinical Score From Baseline to Day 22|Investigator’s rating of the clinical appearance of a psoriatic lesion. Maximum score is 9 (most severe); minimum score is 0 (least severe). The single items erythema, scaling, and infiltration (maximum score 3 each) are summed to obtain the Total Clinical Score. Total Clinical Score range from 0 (all symptoms absent) to 9 (all symptoms severe)|Baseline to Day 22|||units on a scale||Standard Deviation|Mean
679645|NCT01580423|Primary|Unpleasantness of Breathlessness|"Time-weighted averages of unpleasantness of breathlessness.
Subject rating of unpleasantness of breathlessness was obtained at 1 minute intervals during RLB on a 100 mm Visual Analog Scale anchored at the bottom by No Unpleasantness and at the top by Greatest Unpleasantness."|At 1 minute intervals during Resistive Load Breathing at Period 1 (Day 3 or 4) and Period 2 (Day 5, 6 or 7)|||units on a scale||Standard Deviation|Mean
679646|NCT01580423|Secondary|Intensity of Pain|"Time-weighted averages for intensity of pain.
Subject rating of intensity of pain on a 100 mm Visual Analog Scale anchored at the bottom by No Intensity and at the top by Greatest Intensity was obtained during immersion of the subject's non-dominant hand in cold water."|Every 15 seconds during immersion of hand in cold water for up to 5 minutes at Period 1 (Day 3 or 4) and Period 2 (Day 5, 6 or 7)|||units on a scale||Standard Deviation|Mean
679647|NCT01580423|Primary|Intensity of Breathlessness|"Time-weighted averages of intensity of breathlessness.
Subject rating of intensity of breathlessness was obtained at 1 minute intervals during RLB on a 100 mm Visual Analog Scale anchored at the bottom by No Intensity and at the top by Greatest Intensity."|At 1 minute intervals during Resistive Load Breathing at Period 1 (Day 3 or 4) and Period 2 (Day 5, 6 or 7)|||units on a scale||Standard Deviation|Mean
679648|NCT01580306|Secondary|Number of Participants With Drug Related Adverse Events|number of participants with investigator-defined drug related adverse events.|drug administration until end-of-study examination (7 to 14 days after drug administration)|treated set||participants|||Number
686482|NCT01489956|Primary|T Cell Stimulation Index (SI) as Measured by 3H-thymidine Incorporation After in Vitro KLH Stimulation of PBMC (Part A)|No data available for analyses.|Day 16|Data were not collected and therefore no analyses could be performed.|||||
679649|NCT01580306|Secondary|Clinical Relevant Abnormalities for Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG|Clinical relevant abnormalities for Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.|from drug administration up to 2 weeks|treated set||participants|||Number
679650|NCT01580306|Primary|Cmax|maximum concentration of Faldaprevir in plasma. In this endpoint, the data of Cmax show inter-individual variabilities.|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00,16:00, 24:00, 36:00, 48:00, 72:00, 96:00, 120:00, 144:00h after administration|PK set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
679651|NCT01580306|Primary|AUC0-∞|"area under the concentration time curve of Faldaprevir in plasma over the time interval from 0 to infinity.
In this endpoint, the data of AUC0-∞ show inter-individual variabilities."|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00,16:00, 24:00, 36:00, 48:00, 72:00, 96:00, 120:00, 144:00 hours (h) after administration|Pharmacokinetic (PK) set: This subject set included all subjects in the treated set who provided at least 1 observation for at least 1 primary PK endpoint without important protocol violations relevant to the evaluation of PK, and who did not vomit at or before 2 times median tmax of unmetabolised faldaprevir.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
679652|NCT01580098|Secondary|Number of Hospitalisations|The number of inpatient stays comparing intervention and control group was conducted.|12 months|||number of inpatient stays||Standard Deviation|Mean
679653|NCT01580098|Secondary|Presence of Diabetic Complications||12 months|No data about the presence of diabetic complications could be analysed at the end of the study, no data was collected for this secondary outcome.|||||
679654|NCT01580098|Secondary|Medication Changes|Insulin, Change? -> Yes/No|12 months|No data about medical changes could be analysed at the end of the study, no data were collected.|||||
679655|NCT01580098|Secondary|Body Weight||12 months|baseline demographic characteristics; No patients of the Nurse-Monitoring Group finished the study, as a consequence no Body weight after 12 months were delivered, so a calculation and evaluation for this group could not be conducted.||kilograms||Standard Deviation|Mean
679656|NCT01580098|Secondary|Blood Lipids||12 months|Not all Participants delivered reliable data; Measurements at the beginning of the trial and after 12 months; No patients of the Nurse-Monitoring Group finished the study, as a consequence no blood lipids after 12 months were delivered, so a calculation and evaluation for this group could not be conducted.||mg/dL||Standard Deviation|Mean
679657|NCT01580098|Secondary|Blood Pressure||12 months|Not all Participants delivered data, reliable data was used. No patients of the Nurse-Monitoring Group finished the study, as a consequence no blood pressure after 12 months were delivered, so a calculation and evaluation for this group could not be conducted.||mmHg||Standard Deviation|Mean
679658|NCT01580098|Primary|HbA1c|HbA1c was taken at the beginning of the study and after 12 months.|12 months|No patients of the Nurse-Monitoring Group finished the study, as a consequence no HbA1c after 12 months were delivered, so a calculation and evaluation for this group could not be conducted.||HbA1c [%]||Standard Deviation|Mean
679659|NCT01580098|Primary|Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire|"The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status.
Mearurement at the beginning and after 12 months, Scales from 0 to 100, higher values represent a better outcome; Data are mean scores (SD); differences between groups after 12 month were compared by using Mann-Whitney-U-tests."|12 months|No patients of the Nurse-Monitoring Group finished the study, as a consequence no SF36 after 12 months were delivered, so a calculation and evaluation for this group could not be conducted.||units on a scale (General health score)||Standard Deviation|Mean
679660|NCT01580072|Secondary|BODE Index (Carinthia)||12 months||||||
679661|NCT01580072|Secondary|St. George's Respiratory Questionnaire SGRQ (Carinthia)|"The SGRQ is a 50-item questionnaire developed to measure health status (quality of life) in patients with diseases of airways obstruction.
Scores are calculated for three domains:
Symptoms, Activity and Impacts as well as a total score. Psychometric testing has demonstrated its repeatability, reliability and validity. Sensitivity has been demonstrated in clinical trials.
A minimum change in score of 4 units was established as clinically relevant after patient and clinician testing. The SGRQ has been used in a range of disease groups including asthma, chronic obstructive pulmonary disease (COPD) and bronchiectasis, and in a range of settings such as randomised controlled therapy trials and population surveys.Due to missing data not all questoinnaires could be taken into consideration. Normal distribution is not given for SGRQ scales; Scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best pos"|12 months|||units on a scale||Standard Deviation|Mean
679662|NCT01580072|Secondary|COPD Assessment Test CAT (Carinthia)|No data available|12 months||||||
679663|NCT01580072|Secondary|All Cause Mortality|deceased patients in respect to participating patients, by obituary column|12 months||||||
679664|NCT01580072|Secondary|Number of Consultations of Emergency Doctor||12 months|||consultations ED||Standard Deviation|Mean
679665|NCT01580072|Secondary|Number of Specialist Visits||12 months|||visits specialists||Standard Deviation|Mean
679666|NCT01580072|Secondary|Number of Primary Care Visits|Not all data were available, so only participants with consistent data were taken into comparison, this lead to a lower number of patients in this outcome measurement.|12 months|||visits GP||Standard Deviation|Mean
679667|NCT01580072|Secondary|Number of Bed Days for Hospitalised Patients||12 months|||bed days||Standard Deviation|Mean
679668|NCT01580072|Primary|Number of Inpatient Stays||12 months|||inpatient stays||Standard Deviation|Mean
679669|NCT01580072|Primary|Health Related Quality of Life as Measured by the Short-Form 36 Version 2 Questionnaire; The Short Form (36) Health Survey is a 36-item, Patient-reported Survey of Patient Health. The SF-36 is a Measure of Health Status.|Baseline analyses and analyses after 12 months were conducted. Normal distribution is not given for SF-36 scales, means and Standard Deviation are reported. A high score defines a more favorable health state, items are scored on a 0 to 100 range. Scale scores represent the average for all items in the scale that the respondent answered.|12 months|||units on a scale||Standard Deviation|Mean
679735|NCT01579565|Secondary|Ocular Pain VAS Score on Day 1|VAS pain scores (where 0 = no pain and 100 = worst possible pain) after the day of surgery summarized by treatment arm and time point.|One day postoperatively|Subjects with score at time point.||units on a scale||Standard Deviation|Mean
679670|NCT01580020|Secondary|Time to the First Retreatment of Both Treatment Arms|Time to the first retreatment|6 months|The Safety Set consisted of all patients from the safety sets of the respective core study who had received at least one application of study treatment and had at least one safety assessment during the extension study. Patients were analyzed according to treatment received.||Days||95% Confidence Interval|Median
679671|NCT01580020|Secondary|Change in Euro Quality of Life Questionnaire (EQ-5D) VAS Summary Scores|"The Euro Quality of Life Questionnaire (EQ-5D) standardized instrument was utilized to measure health outcomes related to mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Participants self-rate their health on a visual, vertical analogue scale from 0 to 100 where the endpoints are labeled Best imaginable health state (100) and worst imaginable health state (0)."|Baseline, month 12|Full Analysis Sets (FAS) consisted of all patients from the FAS of the respective core study who had received at least one application of study treatment and had at least one post- baseline assessment for BCVA during the extension study. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned.||Score on a scale||Standard Deviation|Mean
679672|NCT01580020|Secondary|Change in SF-36 Summary Scores|The SF-36 measures the impact of disease on overall quality of life and consists of eight subscales (physical function, pain, general and mental health, vitality, social function, physical and emotional health) which can be aggregated to derive a physical-component summary score and a mental-component summary score. Scores for each subscale range from 0 to 10, and the composite scores range from 0 to 100, with higher scores indicating better health. A positive change from Baseline score indicates improvement in quality of life.|Baseline, month 12|Full Analysis Sets (FAS) consisted of all patients from the FAS of the respective core study who had received at least one application of study treatment and had at least one post- baseline assessment for BCVA during the extension study. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned.||Score on a scale||Standard Deviation|Mean
679673|NCT01580020|Secondary|Change in Mean Visual Function Questionnaire (VFQ-25)|The VFQ-25 composite and subscale scores range from 0 to 100, a higher score indicating better functioning. The 12 subscales in the VFQ-25 are general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. The scores on the subscales were added together for a total score, which ranged from 0 to 100. A higher score indicated improvement in quality of life due to vision function.|Baseline, 12 months|Full Analysis Sets (FAS) consisted of all patients from the FAS of the respective core study who had received at least one application of study treatment and had at least one post- baseline assessment for BCVA during the extension study. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned.||Scores on a scale||Standard Deviation|Mean
679674|NCT01580020|Secondary|Change of Foveal Center Point Thickness (FCPT) From Baseline to Month 12|FCPT (foveal center point thickness) was assessed by central reading center to ensure error- corrected measurements of retinal thickness and volumes,|Baseline, Month 12|Full Analysis Sets (FAS) consisted of all patients from the FAS of the respective core study who had received at least one application of study treatment and had at least one post- baseline assessment for BCVA during the extension study. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned.||um||Standard Deviation|Mean
679675|NCT01580020|Secondary|Change in Central Subfield Thickness (CSRT) From Baseline to Month 12|High Resolution OCT was performed at every study visit by Spectral Domain OCT (if not available Time Domain OCT was acceptable) and the images were transferred to a digital video disc. These assessments were performed by trained and adequately qualified experts at the sites and prior to any study drug administration. CSFT is the average retinal thickness of the circular area with 1 mm diameter around the foveal center.|Baseline , Month 12|Full Analysis Sets (FAS) consisted of all patients from the FAS of the respective core study who had received at least one application of study treatment and had at least one post- baseline assessment for BCVA during the extension study. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned.||um||Standard Deviation|Mean
679676|NCT01580020|Secondary|Percentage of Patients Gaining / Losing ≥ 15 / 10 / 5 Letters at Month 12 Compared to Baseline|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who were gaining/losing ≥15, 10 or 5 more letters of visual acuity at month 12 as compared with baseline|12 month|Full Analysis Sets (FAS) consisted of all patients from the FAS of the respective core study who had received at least one application of study treatment and had at least one post- baseline assessment for BCVA during the extension study. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned||Percentage of participants|||Number
679677|NCT01580020|Secondary|Raw Mean Best Corrected Visual Acuity (BCVA) by Treatment Group|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. The range of BCVA (EDTRS) is 0 to 100 letters. A positive change from baseline of BCVA indicates improvement|Baseline, 6 months and 12 months|FAS consisted of all patients from the FAS of the respective core study who had received at least one application of study treatment and had at least one post- baseline assessment for BCVA during the extension study. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned.||Letters read correctly||Standard Deviation|Mean
679678|NCT01580020|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|The number of participants who experienced Adverse events, serious AE and death|6 months|The Safety Set consisted of all patients from the safety sets of the respective core study who had received at least one application of study treatment and had at least one safety assessment during the extension study. Patients were analyzed according to treatment received.||Participants|||Number
679679|NCT01579916|Secondary|Percentage of Participants Who Used Antipyretic or Analgesic Agents Within 14 Days Post Vaccination|Percentage of participants who used an antipyretic or analgesic agent between Days 1 and 15. Investigational product administration occurred on Day 1.|Study Days 1 - 15|All participants who received a single dose of investigational product (trivalent influenza virus vaccine = 241; placebo = 60).||Percentage of Participants|||Number
679680|NCT01579916|Secondary|Percentage of Participants Who Used Antipyretic or Analgesic Agents Within 7 Days Post Vaccination|Percentage of participants who used an antipyretic or analgesic agent between Days 1 and 8. Investigational product administration occurred on Day 1.|Study Days 1 - 8|All participants who received a single dose of investigational product (trivalent influenza virus vaccine = 241; placebo = 60).||Percentage of Participants|||Number
679681|NCT01579916|Secondary|Percentage of Participants Reporting Any New Onset Chronic Diseases (NOCDs) Within 180 Days Post Vaccination|An NOCD was a newly diagnosed medical condition of a chronic, ongoing nature and assessed by the investigator as medically significant. Such events were assessed between Day 1 and Day 181. Investigational product was administered on Day 1.|Study Days 1 - 181|All participants who received a single dose of investigational product (trivalent influenza virus vaccine = 241; placebo = 60).||Percentage of participants|||Number
679682|NCT01579916|Secondary|Percentage of Participants Reporting Any New Onset Chronic Diseases (NOCDs) Within 28 Days Post Vaccination|An NOCD was a newly diagnosed medical condition of a chronic, ongoing nature and assessed by the investigator as medically significant. Such events were assessed between Day 1 and Day 29. Investigational product was administered on Day 1.|Study Days 1 - 29|All participants who received a single dose of investigational product (trivalent influenza virus vaccine = 241; placebo = 60).||Percentage of participants|||Number
679683|NCT01579916|Secondary|Percentage of Participants Reporting Any Serious Adverse Event (SAE) Within 180 Days Post Vaccination|Percentage of participants reporting at least one SAE between Days 1 and 181. Investigational product was administered on Day 1.|Study Days 1 - 181|All participants who received a single dose of investigational product (trivalent influenza virus vaccine = 241; placebo = 60).||Percentage of participants|||Number
679684|NCT01579916|Secondary|Percentage of Participants Reporting Any Serious Adverse Event (SAE) Within 28 Days Post Vaccination|Percentage of participants reporting at least one SAE between Days 1 and 29. Investigational product was administered on Day 1.|Study Days 1 - 29|All participants who received a single dose of investigational product (trivalent influenza virus vaccine = 241; placebo = 60).||Percentage of participants|||Number
679685|NCT01579916|Secondary|Percentage of Participants Reporting Any Adverse Event (AE) Within 14 Days Post Vaccination|Percentage of participants reporting at least one AE between Days 1 and 15. Investigational product was administered on Day 1.|Study Days 1 - 15|All participants who received a single dose of investigational product (trivalent influenza virus vaccine = 241; placebo = 60).||Percentage of participants|||Number
679686|NCT01579916|Secondary|Percentage of Participants Reporting Other Solicited Symptoms Within 14 Days Post Vaccination|Solicited symptoms were events that were considered likely to occur post dosing. Solicited symptoms for this study are listed below.|Study Days 1 - 15|All participants who received a single dose of investigational product (trivalent influenza virus vaccine = 241; placebo = 60).||Percentage of participants|||Number
679687|NCT01579916|Secondary|Percentage of Participants Reporting Any Adverse Event (AE) Within 7 Days Post Vaccination|Percentage of participants reporting at least one AE between Days 1 and 8. Investigational product was administered on Day 1.|Study Days 1 - 8|All participants who received a single dose of investigational product (trivalent influenza virus vaccine = 241; placebo = 60).||Percentage of participants|||Number
679688|NCT01579916|Secondary|Percentage of Participants Reporting Other Solicited Symptoms Within 7 Days Post Vaccination|Solicited symptoms were events that were considered likely to occur post dosing. Solicited symptoms for this study are listed below.|Study Days 1- 8|All participants who received a single dose of investigational product (trivalent influenza virus vaccine = 241; placebo = 60)||Percentage of Participants|||Number
679689|NCT01579916|Primary|Percentage of Participants Reporting Fever Within 7 Days Post Vaccination|A comparison of the rate of fever, defined as oral temperature greater than or equal to 101 degrees Fahrenheit, reported during the 7 days post administration of investigational product between the trivalent influenza virus vaccine and placebo groups.|Study Days 1 - 8|All participants who received a single dose of investigational product (trivalent influenza vaccine = 241; placebo = 60).||Percentage of Participants|||Number
679690|NCT01578850|Secondary|Change in CRP and ESR at Each Visit During Period 2|The DAS assessment is a derived measurement with differential weight given to each component. The DAS28-ESR and DAS28-CRP was calculated at every visit within the clinical database in period 1. The components of the DAS28 ESR score assessment are: Tender/ Painful Joint Count (28), Swollen Joint Count (28); ESR, Subject General Health VAS assessment. The components of the DAS28 CRP score assessment were: Tender/Painful Joint Count (28); Swollen Joint Count (28), hsCRP, and the Subject General Health VAS assessment. This efficacy measurement was made at every study visit.|Baseline, Weeks 24, 28, 36, 44 and 52|The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.||units on a scale||Standard Deviation|Mean
679691|NCT01578850|Secondary|Change in CRP and ESR at Each Visit During Period 1|The DAS assessment is a derived measurement with differential weight given to each component. The DAS28-ESR and DAS28-CRP was calculated at every visit within the clinical database in period 1. The components of the DAS28 ESR score assessment are: Tender/ Painful Joint Count (28), Swollen Joint Count (28); ESR, Subject General Health VAS assessment. The components of the DAS28 CRP score assessment were: Tender/Painful Joint Count (28); Swollen Joint Count (28), hsCRP, and the Subject General Health VAS assessment. This efficacy measurement was made at every study visit.|Baseline, Weeks 4, 8, 16 and 24|The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).||units on a scale||Standard Deviation|Mean
679692|NCT01578850|Secondary|Change in the Subject General Health VAS and Pain VAS at Each Visit During Period 2|Participants were asked to answer the question “In general how would you rate your health over the last 2-3 weeks?” by marking a vertical line at the appropriate position through the 100 mm VAS. The length on the line was measured from the left (in mm). For Pain VAS, participants assessed the severity of their arthritis pain during the last 2 to 3 days using a 100 mm VAS by marking a vertical line at the appropriate position on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.|Baseline, Weeks 24, 28, 36, 44 and 52|The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.||units on a scale||Standard Deviation|Mean
679693|NCT01578850|Secondary|Change in the Subject General Health Visual Analog Scale (VAS) and Pain VAS at Each Visit During Period 1|Participants were asked to answer the question “In general how would you rate your health over the last 2 3 weeks?” by marking a vertical line at the appropriate position through the 100 mm VAS. The length on the line was measured from the left (in mm). For Pain VAS, participants assessed the severity of their arthritis pain during the last 2 to 3 days using a 100 mm VAS by marking a vertical line at the appropriate position on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.|Baseline, Weeks 4, 8, 16 and 24|The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).||units on a scale||Standard Deviation|Mean
679694|NCT01578850|Secondary|Change in Morning Stiffness (Measured in Minutes) at Each Visit During Period 2|Morning stiffness was defined as stiffness in and around the joints, lasting at least 1 hour before maximal improvement. Participants assessed their overall disease activity over the last 2 to 3 days using a scale between 0 (no disease activity) and 10 (extreme disease activity), which corresponded to the magnitude of their pain) and marked one number with an ‘X’.|Baseline, Weeks 24, 28, 36, 44 and 52|The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.||minutes||Standard Deviation|Mean
679695|NCT01578850|Secondary|Change in Morning Stiffness (Measured in Minutes) at Each Visit During Period 1|Morning stiffness was defined as stiffness in and around the joints, lasting at least 1 hour before maximal improvement. Participants assessed their overall disease activity over the last 2 to 3 days using a scale between 0 (no disease activity) and 10 (extreme disease activity), which corresponded to the magnitude of their pain) and marked one number with an ‘X’.|Baseline, Weeks 4, 8, 16 and 24|The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).||minutes||Standard Deviation|Mean
679696|NCT01578850|Secondary|Change in the Subject Global Assessment of Arthritis in Period 2|Subjects assessed their overall disease activity over the last 2 to 3 days using a scale between 0 (no disease activity) and 10 (extreme disease activity), which corresponded to the magnitude of their pain) and marked one number with an ‘X’.|Baseline, Weeks 24, 28, 36, 44 and 52|The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.||units on a scale||Standard Deviation|Mean
679697|NCT01578850|Secondary|Change in the Subject Global Assessment of Arthritis in Period 1|Subjects assessed their overall disease activity over the last 2 to 3 days using a scale between 0 (no disease activity) and 10 (extreme disease activity), which corresponded to the magnitude of their pain) and marked one number with an ‘X’.|Baseline, Weeks 4, 8, 16 and 24|The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).||units on a scale||Standard Deviation|Mean
679698|NCT01578850|Secondary|Change in the Physician Global Assessment of Arthritis at Each Visit During Period 2|The investigator estimated the subject’s overall disease activity over the last 2 to 3 days (independent of the Subject Global Assessment of arthritis) using a scale between 0 (no disease activity) and 10 (extreme disease activity) and marking one number with an ‘X’.|Baseline, Weeks 24, 28, 36, 44 and 52|The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.||units on a scale||Standard Deviation|Mean
679699|NCT01578850|Secondary|Change in the Physician Global Assessment of Arthritis at Each Visit During Period 1|The investigator estimated the subject’s overall disease activity over the last 2 to 3 days (independent of the Subject Global Assessment of arthritis) using a scale between 0 (no disease activity) and 10 (extreme disease activity) and marking one number with an ‘X’.|Baseline, Weeks 4, 8, 16 and 24|The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).||units on a scale||Standard Deviation|Mean
679700|NCT01578850|Secondary|Change in the Tender and Swollen Joint Counts at Each Visit During Period 2 (Using 28 Joint Count as Well as 66/68 Joint Counts).|A total of 66 swollen and 68 tender joints were assessed for tenderness/pain and swelling by the same qualified personnel (when possible) at each visit. For ACR responses, a 66/68 joint count was used. For DAS28-ESR, Simplified Disease Activity Index (SDAI), and Clinical Disease Activity Index (CDAI) calculations, the 28 joint count was used, which included: shoulders, elbows, wrists, metacarpophalangeal (MCP) joints, proximal interphalangeal (PIP) joints, and knees.|Baseline, Weeks 24, 28, 36, 44 and 52|The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.||units on a scale||Standard Deviation|Mean
679701|NCT01578850|Secondary|Change in the Tender and Swollen Joint Counts at Each Visit During Period 1 (Using 28 Joint Count as Well as 66/68 Joint Counts).|A total of 66 swollen and 68 tender joints were assessed for tenderness/pain and swelling by the same qualified personnel (when possible) at each visit. For ACR responses, a 66/68 joint count was used. For DAS28-ESR, Simplified Disease Activity Index (SDAI), and Clinical Disease Activity Index (CDAI) calculations, the 28 joint count was used, which included: shoulders, elbows, wrists, metacarpophalangeal (MCP) joints, proximal interphalangeal (PIP) joints, and knees.|Baseline, Weeks 4, 8, 16 and 24|The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).||Units on a scale||Standard Deviation|Mean
679736|NCT01579565|Secondary|Ocular Pain-Free (VAS Equal to 0) at All Time Points During 12 Hours Postoperatively|The number of subjects who report ocular pain-free status (VAS equal to 0) at all time points during 12 hours postoperatively summarized by treatment arm. Subjects with missing VAS scores during the 12 hours postoperatively were considered as not being pain-free.|12 hours postoperatively|Subjects with scores at time points.||participants|||Number
679737|NCT01579565|Secondary|Moderate-to-Severe Pain (VAS Greater Than or Equal to 40) at Any Time Point During 12 Hours Postoperatively|The number of subjects with moderate -to-severe pain (VAS greater than or equal to 40) at any time point during 12 hours postoperatively summarized by treatment arm.|12 hours postoperatively|Subjects with VAS scores at time points.||participants|||Number
679702|NCT01578850|Secondary|Percentage of Participants Achieving ACR20, ACR50, ACR70 and ACR90 (by 66/68 Joint Counts) During Period 2 at Each Visit.|A 66 swollen and 68 tender joint count was used for calculating ACR responses. The ACR’s definition for calculating improvement in RA (ACR20) was calculated as a 20% improvement in tender and swollen joint counts and 20% improvement in 3 of the 5 remaining ACR core set measures: subject and physician global assessments of arthritis, pain, disability, and an acute phase reactant. Similarly, ACR50, ACR70 and ACR90 were calculated with the respective percent improvement. This efficacy measurement was made at every study visit.|Baseline, Weeks 24, 28, 36, 44 and 52|The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.||Percentage of participants|||Number
679703|NCT01578850|Secondary|Percentage of Participants Achieving American College of Rheumatology (ACR) ACR20, ACR50, ACR70 and ACR90 (by 66/68 Joint Counts) During Period 1 at Each Visit.|A 66 swollen and 68 tender joint count was used for calculating ACR responses. The ACR’s definition for calculating improvement in RA (ACR20) was calculated as a 20% improvement in tender and swollen joint counts and 20% improvement in 3 of the 5 remaining ACR core set measures: subject and physician global assessments of arthritis, pain, disability, and an acute phase reactant. Similarly, ACR50, ACR70 and ACR90 were calculated with the respective percent improvement. This efficacy measurement was made at every study visit.|Baseline, Weeks 4, 8, 16 and 24|The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).||percentage of participants|||Number
679704|NCT01578850|Secondary|Change of CDAI and SDAI at Each Visit During Period 2|"SDAI and CDAI are defined as:
1) SDAI = DAS28 prorated Swollen Joint Count (0-28) + DAS28 prorated Tender Joint Count (0-28) + Physician Global Assessment of arthritis (0-10) + Subject Global Assessment of arthritis (0-10) + hs CRP (in mg/dL) in Period 2. 2) CDAI = DAS28 prorated Swollen Joint Count (0-28) + DAS28 prorated Tender Joint Count (0 28) + Physician Global Assessment of arthritis (0-10) + Subject Global Assessment of arthritis (0-10) in Period 2."|Baseline, Weeks 24, 28, 36, 44 and 52|The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.||units on a scale||Standard Deviation|Mean
679705|NCT01578850|Secondary|Change of CDAI and SDAI at Each Visit During Period 1.|"SDAI and CDAI are defined as:
1) SDAI = DAS28 prorated Swollen Joint Count (0-28) + DAS28 prorated Tender Joint Count (0-28) + Physician Global Assessment of arthritis (0-10) + Subject Global Assessment of arthritis (0-10) + hs CRP (in mg/dL) in Period 1. 2) CDAI = DAS28 prorated Swollen Joint Count (0-28) + DAS28 prorated Tender Joint Count (0 28) + Physician Global Assessment of arthritis (0-10) + Subject Global Assessment of arthritis (0-10) in Period 1."|Baseline, Weeks 4, 8, 16 and 24|The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).||units on a scale||Standard Deviation|Mean
679706|NCT01578850|Secondary|Percentage of Participants Achieving LDA or Remission Based on CDAI and SDAI at Each Visit During Period 2.|"SDAI and CDAI are defined as:
1) SDAI = DAS28 prorated Swollen Joint Count (0-28) + DAS28 prorated Tender Joint Count (0-28) + Physician Global Assessment of arthritis (0-10) + Subject Global Assessment of arthritis (0-10) + hs CRP (in mg/dL) in Period 2. 2) CDAI = DAS28 prorated Swollen Joint Count (0-28) + DAS28 prorated Tender Joint Count (0 28) + Physician Global Assessment of arthritis (0-10) + Subject Global Assessment of arthritis (0-10) in Period 2."|Baseline, Weeks 24, 28, 36, 44 and 52|The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization||Percentage of participants|||Number
679707|NCT01578850|Secondary|Percentage of Participants Achieving LDA or Remission Based on Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) at Each Visit During Period 1.|"SDAI and CDAI are defined as:
1) SDAI = DAS28 prorated Swollen Joint Count (0-28) + DAS28 prorated Tender Joint Count (0-28) + Physician Global Assessment of arthritis (0-10) + Subject Global Assessment of arthritis (0-10) + hs CRP (in mg/dL) in Period 1. 2) CDAI = DAS28 prorated Swollen Joint Count (0-28) + DAS28 prorated Tender Joint Count (0 28) + Physician Global Assessment of arthritis (0-10) + Subject Global Assessment of arthritis (0-10) in Period 1."|Baseline, Weeks 4, 8, 16 and 24|The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).||Percentage of participants|||Number
679708|NCT01578850|Secondary|Percentage of Participants Achieving EULAR Good and or Moderate Responses (by Both DAS28-ESR and DAS28-CRP Scores) at Each Visit During Period 2.|EULAR response is based on DAS28-ESR scores. The following good and moderate response is defined based on DAS28-ESR at endpoint (DAS28-ESR improvement at from Baseline in parenthesis): ≤3.2 units (>1.2 units) is good response; ≤3.2 units (0.6-1.2 units) are moderate response; ≤3.2 units (≤0.6 units) are no response.|Baseline, Weeks 24, 28, 36, 44 and 52|The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.||Percentage of participants|||Number
679709|NCT01578850|Secondary|Percentage of Participants Achieving European League Against Rheumatism (EULAR) Good and or Moderate Responses (by Both DAS28-ESR and DAS28-CRP Scores) at Each Visit During Period 1.|EULAR response is based on DAS28-ESR scores. The following good and moderate response is defined based on DAS28-ESR at endpoint (DAS28-ESR improvement at from Baseline in parenthesis): ≤3.2 units (>1.2 units) is good response; ≤3.2 units (0.6-1.2 units) are moderate response; ≤3.2 units (≤0.6 units) are no response.|Baseline, Weeks 4, 8, 16 and 24|The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).||Percentage of participants|||Number
679710|NCT01578850|Secondary|Percentage of Participants Who Had a Recurrence of Disease Symptoms During Period 2, Based on the Protocol Criteria|Flare is defined as the criteria of loss of LDA plus ≥0.6 unit worsening in DAS28-ESR score during period 2.|Baseline and Week 52|The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.||Percentage of participants|||Number
679711|NCT01578850|Secondary|Change From Baseline in DAS28-CRP and DAS28-ESR in Period 2|The DAS assessment is a derived measurement with differential weight given to each component. The DAS28-ESR and DAS28-CRP was calculated at every visit within the clinical database in period 2. The components of the DAS28 ESR score assessment are: Tender/ Painful Joint Count (28), Swollen Joint Count (28); ESR, Subject General Health VAS assessment. The components of the DAS28 CRP score assessment were: Tender/Painful Joint Count (28); Swollen Joint Count (28), hsCRP, and the Subject General Health VAS assessment. This efficacy measurement was made at every study visit.|Baseline, Weeks 24, 28, 36, 44 and 52|The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.||units on a scale||Standard Deviation|Mean
679712|NCT01578850|Secondary|Change From Baseline in DAS28-CRP and DAS28-ESR in Period 1|The DAS assessment is a derived measurement with differential weight given to each component. The DAS28-ESR and DAS28-CRP was calculated at every visit within the clinical database in period 1. The components of the DAS28 ESR score assessment are: Tender/ Painful Joint Count (28), Swollen Joint Count (28); ESR, Subject General Health VAS assessment. The components of the DAS28 CRP score assessment were: Tender/Painful Joint Count (28); Swollen Joint Count (28), hsCRP, and the Subject General Health VAS assessment. This efficacy measurement was made at every study visit.|Baseline, Weeks 4, 8, 16 and 24|The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).||units on a scale||Standard Deviation|Mean
679713|NCT01578850|Secondary|Percentage of Participants Achieving Remission (DAS28-ESR and DAS28-CRP) at Each Visit During Period 2|Proportion of participants who achieved LDA (DAS28-ESR and DAS28-CRP at each visit during period 2 is presented below.|Baseline, Weeks 24, 28, 36, 44 and 52|The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.||Percentage of participants|||Number
679714|NCT01578850|Secondary|Percentage of Participants Achieving Remission (DAS28-ESR and DAS28-CRP) at Each Visit During Period 1|Proportion of participants who achieved remission (DAS28-ESR and DAS28-CRP at each visit during period 1 is presented below.|Baseline, Weeks 4, 8, 16 and 24|The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).||Percentage of participants|||Number
679715|NCT01578850|Secondary|Percentage of Participants Achieving LDA (DAS28-ESR and DAS28-CRP) at Each Visit During Period 2|Proportion of participants who achieved LDA (DAS28-ESR and DAS28-CRP at each visit during period 2 is presented below.|Baseline, Weeks 24, 28, 36, 44 and 52|The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.||Percentage of participants|||Number
679716|NCT01578850|Secondary|Percentage of Participants Achieving LDA (DAS28-ESR and DAS28-C-reactive Protein [CRP]) at Each Visit During Period 1|Proportion of participants who achieved LDA (DAS28-ESR and DAS28-CRP at each visit during period 1 is presented below.|Baseline, Weeks 4, 8, 16 and 24|The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).||Percentage of participants|||Number
679717|NCT01578850|Secondary|Percentage of Participants Who Remained in Remission at Week 52 (DAS28-ESR)|Proportion of participants who remained in Remission (DAS28-ESR <2.6) at Week 52.|Baseline and Week 52|The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.||Percentage of participants|||Number
679718|NCT01578850|Primary|Percentage of Participants Who Remained in Low Disease Activity (LDA) (Disease Activity Score in 28 Joints-erythrocyte Sedimentation Rate [DAS28-ESR] <3.2) at Week 52.|Proportion of participants who remained in LDA DAS28-ESR <3.2 at Week 52 is presented below.|Baseline and Week 52|The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.||percentage of participants|||Number
679719|NCT01579747|Secondary|Number of Redirections|Number of needle redirections defined as needle withdrawal followed by advancement as an intentional movement.|6 months|||passes||Inter-Quartile Range|Median
679720|NCT01579747|Primary|Procedural Time|Time taken to complete a sciatic nerve block via the lateral popliteal approach using ultrasound vs nerve stimulation technique|less than 30 minutes|||seconds||Standard Deviation|Mean
679721|NCT01579669|Secondary|Change in Patient Healthcare Self-Efficacy|Autistic participants completed a 21-item healthcare self-efficacy scale before and 1 month after use of the toolkit. The scale was created de novo for this study, based on our prior qualitative work. Items addressed aspects related to healthcare navigation (e.g. “How confident are you that you can make an appointment with your healthcare provider when needed?”), successful interactions with providers, (e.g. “How confident are you that you can describe your symptoms or healthcare concerns to your provider?”), and self-management (e.g. “How confident are you that you can take medications the way you are supposed to take them?”). Response options used a 4-point Likert scale with anchors of “0 - Not at all confident” to “3 - Totally confident”. We scored self-efficacy by adding responses from the 21 items, resulting in a possible range of 0 to 63, with higher scores corresponding to higher self-efficacy. Cronbach's alpha was 0.92.|Before and 1 month after use of toolkit|Participants completing pre- and post-intervention survey themselves (not via a supporter), who had complete data on the self-efficacy scales on both surveys.||units on a scale||Standard Error|Mean
679722|NCT01579669|Secondary|Change in Patient's Perceived Barriers to Healthcare|Autistic participants were presented with a list of 16 barriers to healthcare and asked which ones keep them from obtaining good care. We compared the total number of barriers endorsed by participants in the pre- and post-intervention surveys. The proxy version of the survey included a few modified items to differentiate between barriers faced by the autistic individuals and those faced by the supporter. Due to differences in the wording, we could not combine results from those who participated directly with those who participated by proxy. Only data from autistic adults who participated directly is shown.|Before and 1 month after use of toolkit|Participants completing the pre and post-test themselves (not via a supporter).||number of barriers||Standard Error|Mean
679723|NCT01579669|Secondary|Change in Patient Satisfaction With Healthcare|Patients completed an 8-item instrument assessing satisfaction with their primary healthcare experiences. The scale was previously adapted from the 2007 Health Information National Trends Survey (HINTS). In the pre-intervention survey autistic participants were asked to think about their last visit with their primary care provider. We did not assess patient-provider communication for those who were participating via a proxy as we did not feel that a proxy could adequately rate how satisfied the patient was with communication. Only autistic participants who said they had seen their PCP since using the healthcare toolkit were re-asked these items in the post-intervention survey. Responses used a 5-point Likert scale with anchors of “1 – Strongly Disagree” to “5 – Strongly Agree”. We analyzed items by summing the responses into a composite score (range 8-40; higher scores indicate higher satisfaction). Cronbach's alpha = 0.92.|before and 1 month after use of toolkit|Autistic adults who participated directly (not via a proxy) and who saw their provider in the 1 month between when they participated in the baseline assessment and they completed the post-intervention survey.||units on a scale||Standard Error|Mean
679724|NCT01579669|Secondary|Patient Use of Toolkit Components|We collected data on whether or not participants completed the Autism Healthcare Accommodations Tool (AHAT) survey and whether or not they allowed the research team to send a copy of the report to their primary care provider.|1 month after use of toolkit|||percentage of participants|||Number
679725|NCT01579669|Secondary|Provider Satisfaction|Providers participated in a brief survey to assess satisfaction with the toolkit. Items addressed overall satisfaction and if they would or would not use the tools with other patients.|1-2 months after patient uses toolkit|Participants' primary care providers. Primary care providers were included in the study to assess their impression of the toolkit, but all other outcomes (e.g. change in barriers, self-efficacy, or satisfaction with healthcare) only apply to the autistic participants, not their primary care providers.||percentage of PCPs|||Number
679726|NCT01579669|Primary|Patient Satisfaction|Autistic participants completed an online survey about their satisfaction with the tool, including if they feel the tool is useful, how they think the tool will affect their healthcare, if and how they plan to use it with providers, and if they would recommend it to others.|1 month after use of toolkit|||percentage of participants|||Number
679727|NCT01579578|Secondary|The Objective Response Rate (ORR) Was Analysed for Investigating the Efficacy of AZD8931 Plus Paclitaxel With Paclitaxel Alone|The number of subjects with at least one visit response of CR or PR. (Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive disease (PD), A ≥ 20% increase in the sum of diameters of target lesions and an absolute increase of ≥ 5mm; Stable disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Not Evaluable (NE), All target lesion measurements are missing or >1/3 target lesion measurements are missing and sum of diameters of non-missing target lesions does not qualify for PD; Not applicable (NA), No target lesions are recorded at baseline)|Baseline and 8 weeks, accessed up to data cut off on 4 December 2012|Full analysis set||Participants|||Number
679728|NCT01579578|Secondary|Progression-free Survival (PFS) Were Analysed for Comparing Relative Efficacy of AZD8931 Plus Paclitaxel With Paclitaxel Alone|Time from the date of randomization until the date of objective disease progression (as per RECIST1.1) or the date of death (by any cause in absence of progression).|Baseline and every 8 weeks, accessed up to data cut off on 4 December 2012|||months|Participants|Inter-Quartile Range|Median
679729|NCT01579578|Primary|Change in Tumour Size at 8 Weeks Were Analyzed for Comparing Relative Efficacy of AZD8931 Plus Paclitaxel With Paclitaxel Alone||Baseline and 8 weeks, accessed up to data cut off on 4 December 2012|Full Analysis Set||percentage change|Participants|Standard Error|Least Squares Mean
679730|NCT01579565|Secondary|Systemic Pharmacokinetics (PK) of OMS302|Systemic pharmacokinetics (PK) of phenylephrine (PE) and ketorolac (KE) were performed in a subset of subjects. Descriptive summary statistics for area-under-the-serum-concentration-time curve (AUC), maximum concentration (Cmax), time to Cmax (Tmax), and terminal phase half-life (t1/2) were to be generated if measured plasma concentrations were adequate for analysis. Descriptive statistics for pharmacokinetics were not performed as detected concentrations were low and insufficient for analysis.|24 hours|Subset of subjects randomized to OMS302 treatment.||participants|||Number
679731|NCT01579565|Secondary|Postoperative Best Corrected Visual Acuity (BVCA) on Day 1|Best Corrected Visual Acuity (BCVA) summarized by the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity log score. The reason for missing scores (e.g., subject could not read enough letters to obtain a score or refraction was not completed) was also summarized. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis.|One day postoperatively|Subjects with score at time point.||Log score||Standard Deviation|Mean
679732|NCT01579565|Secondary|Postoperative Ocular Inflammation - Mean Summed Ocular Inflammation Score (SOIS) on Day 1|"Postoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject’s anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.
Grading was as follows:
Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.
Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous"|One day postoperatively|Subjects with scores at time point.||units on a scale||Standard Deviation|Mean
679733|NCT01579565|Secondary|Ocular Symptoms Using Numerical Rating System (NRS) – Photophobia 1 Day Post-Surgery|Photophobia outcomes based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point.|One day postoperatively|Subjects with scores at time point.||participants|||Number
679734|NCT01579565|Secondary|Ocular Symptoms Using Numerical Rating System (NRS) – Photophobia 6 Hours Post-Surgery|Photophobia outcomes based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point.|Six hours postoperatively|Subjects with scores at time point.||participants|||Number
679739|NCT01579565|Secondary|Pupil Diameter Greater Than or Equal to 6 mm at Completion of Cortical Clean up|The number of subjects with pupil diameter of at least 6 mm at the completion of cortical clean up summarized by treatment arm. The last pupil diameter was used if not available at completion of cortical clean up.|at time of cortical clean-up (i.e., end of surgical procedure)|Subjects with interpretable video images obtained during ILR procedure.||participants|||Number
679740|NCT01579565|Primary|Mean Area Under the Curve Analysis of Ocular Pain VAS Score Within 12 Hours Postoperatively|The co-primary analysis of the ocular pain VAS (where 0 = no pain and 100 = worst possible pain) based on the mean area under the curve (AUC). The AUC of the ocular pain VAS during 12 hours postoperatively was calculated by the trapezoidal rule in which the hour 11 was used to represent the time-point 10-12 hour. The mean AUC was defined as the AUC divided by the number of hours with ocular pain VAS results during the first 12 hours postoperatively.|12 hours postoperatively|Subjects with scores at time points.||units on a scale||Standard Deviation|Mean
679741|NCT01579565|Primary|Mean Area Under the Curve Analysis of Change-from-Baseline in Pupil Diameter (mm) During Surgery|The co-primary analysis of the change in pupil diameter based on the mean area under the curve (AUC) pupil diameter change from baseline. First, the AUC of the pupil diameter from surgical baseline to wound closure was calculated using the trapezoidal rule. Second, the mean AUC was obtained by dividing the AUC by the total time of surgery. Third, the mean AUC of change from baseline was calculated by subtracting the baseline pupil diameter from the mean AUC.|From surgery baseline (pre-incision) through surgery end (time of cortical clean-up/wound closure)|Subjects with interpretable video images obtained during intraocular lens replacement (ILR) procedure.||mm||Standard Deviation|Mean
679742|NCT01579474|Secondary|Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO|This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline|12 weeks after the EOT (up to Week 36 or 60)|FAS (All patients who were randomized and received at least 1 dose of the trial medication)||participants|||Number
679743|NCT01579474|Secondary|Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES|This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline|12 weeks after the EOT (up to Week 36 or 60)|FAS (All patients who were randomized and received at least 1 dose of the trial medication)||participants|||Number
679744|NCT01579474|Secondary|Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO|This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline|EOT (up to Week 24 or 48)|FAS (All patients who were randomized and received at least 1 dose of the trial medication)||participants|||Number
679745|NCT01579474|Secondary|Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES|This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline|EOT (up to Week 24 or 48)|FAS (All patients who were randomized and received at least 1 dose of the trial medication)||participants|||Number
679746|NCT01579474|Secondary|Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO|This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline|12 weeks after the EOT (up to Week 36 or 60)|FAS (All patients who were randomized and received at least 1 dose of the trial medication)||participants|||Number
679747|NCT01579474|Secondary|Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES|This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline|12 weeks after the EOT (up to Week 36 or 60)|FAS (All patients who were randomized and received at least 1 dose of the trial medication)||participants|||Number
679748|NCT01579474|Secondary|Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO|This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline|EOT (up to Week 24 or 48)|FAS (All patients who were randomized and received at least 1 dose of the trial medication)||participants|||Number
679749|NCT01579474|Secondary|Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES|This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline|EOT (up to Week 24 or 48)|FAS (All patients who were randomized and received at least 1 dose of the trial medication)||participants|||Number
679750|NCT01579474|Secondary|Early Treatment Success (ETS), Defined as Plasma HCV RNA <25 IU/mL at Week 4 and HCV RNA Undetectable at Week 8|Plasma HCV RNA level <25 IU/mL (detected or undetected) at Week 4 and HCV RNA <25 IU/mL (undetected) at Week 8|up to 8 weeks|FAS (All patients who were randomized and received at least 1 dose of the trial medication)||percentage of participants|||Number
679751|NCT01579474|Secondary|Sustained Virological Response (SVR24), Defined as Plasma HCV RNA Undetectable at 24 Weeks After End of Treatment (EOT)|Plasma HCV RNA level <25 IU/mL (undetected) 24 weeks after the originally planned treatment duration|EOT (up to Week 24 or 48) and 24 weeks after the EOT (up to Week 48 or 72)|FAS (All patients who were randomized and received at least 1 dose of the trial medication)||percentage of participants||95% Confidence Interval|Number
679752|NCT01579474|Secondary|Sustained Virological Response (SVR12), Defined as Plasma HCV RNA Undetectable at 12 Weeks After End of Treatment (EOT)|Plasma hepatitis C virus (HCV) ribonucleic acid (RNA) level <25 IU/mL (undetected) 12 weeks after the originally planned treatment duration|EOT (up to Week 24 or 48) and 12 weeks after the EOT (up to Week 36 or 60)|FAS (All patients who were randomized and received at least 1 dose of the trial medication)||percentage of participants||95% Confidence Interval|Number
679753|NCT01579474|Primary|Number of Patients With Investigator Defined Drug-related Adverse Events|Drug-related AEs were defined as those whose causal relationship with any one of the investigational products was considered by the investigator.|Up to 52 weeks|Safety analyses were based on the safety analysis set (SAF) that included all patients who took the trial medication and were documented to have taken at least 1 dose of the trial medication.||participants|||Number
679754|NCT01579305|Primary|Month 3 Overall Lip Fullness Scale Responder Rate Based on Independent Central Reviewer’s Assessment|The primary effectiveness variable is the responder rate (percentage of subjects who show ≥ 1-point improvement on the 5-point Lip Fullness Scale (Minimal, Mild, Moderate, Marked, Very Marked) compared to baseline assessment, as determined by Independent Central Reviewer evaluation of 3D photographic images).|3 months|Per-protocol population (all subjects who are randomized, received at least 1 study treatment, and have no protocol deviations that affect the primary effectiveness endpoint)||Percentage of subjects||95% Confidence Interval|Number
679755|NCT01579084|Primary|Percentage of Responders With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject’s Self Assessment (SSA) at Day 5|The percentage of responders was determined by facial sides with at least a 2-grade decrease from Baseline (Improvement) in the CEA score and at least a 2-grade decrease from Baseline (Improvement) in the SSA score at Day 5. The investigator evaluated the severity of the participant's erythema (redness of the skin) as measured by the CEA using a 5-point scale where 0=clear skin with no signs of erythema; 1=almost clear of erythema, slight redness; 2=mild erythema, definite redness; 3=moderate erythema, marked redness and 4=severe erythema, fiery redness. The participant assessed the severity of their erythema as measured by the SSA using a 5-point scale where 0=clear of unwanted redness; 1=nearly clear of unwanted redness; 2=somewhat more redness than I prefer; 3=more redness than I prefer and 4=completely unacceptable redness.|Baseline, Day 5-hour 6|Modified Intent-to-treat population consisted of all randomized patients who received study medication and who had measurements at Baseline and at least 1 post-baseline measurement for both CEA and SSA.||Percentage of responders|Participants||Number
679756|NCT01579084|Secondary|Percentage of Responders With at Least a 2-Grade Decrease From Baseline on SSA|The percentage of responders was determined by facial sides with at least a 2-grade decrease from Baseline (Improvement) in the SSA score at Day 1 and Day 5. The participant assessed the severity of their erythema as measured by the SSA using a 5-point scale where 0=clear of unwanted redness; 1=nearly clear of unwanted redness; 2=somewhat more redness than I prefer; 3=more redness than I prefer and 4=completely unacceptable redness.|Baseline, Day1-hour 6, Day 5-hour 6|Modified Intent-to-treat population consisted of all randomized patients who received study medication and who had measurements at Baseline and at least 1 post-baseline measurement for both CEA and SSA.||Percentage of responders|Participants||Number
679757|NCT01579084|Secondary|Percentage of Responders With at Least a 2-Grade Decrease From Baseline on CEA|The percentage of responders was determined by facial sides with at least a 2-grade decrease from Baseline (Improvement) in the CEA score at Day 1 and Day 5. The investigator evaluated the severity of the participant's erythema (redness of the skin) as measured by the CEA using a 5-point scale where 0=clear skin with no signs of erythema; 1=almost clear of erythema, slight redness; 2=mild erythema, definite redness; 3=moderate erythema, marked redness and 4=severe erythema, fiery redness.|Baseline, Day 1-hour 6, Day 5-hour 6|Modified Intent-to-treat population consisted of all randomized patients who received study medication and who had measurements at Baseline and at least 1 post-baseline measurement for both CEA and SSA.||Percentage of responders|Participants||Number
679758|NCT01579084|Primary|Percentage of Responders With at Least a 2-Grade Decrease From Baseline in Both Clinician Erythema Assessment (CEA) and Subject’s Self Assessment (SSA) at Day 1|The percentage of responders was determined by facial sides with at least a 2-grade decrease from Baseline (Improvement) in the CEA score and at least a 2-grade decrease from Baseline (Improvement) in the SSA score at Day 1. The investigator evaluated the severity of the participant's erythema (redness of the skin) as measured by the CEA using a 5-point scale where 0=clear skin with no signs of erythema; 1=almost clear of erythema, slight redness; 2=mild erythema, definite redness; 3=moderate erythema, marked redness and 4=severe erythema, fiery redness. The participant assessed the severity of their erythema as measured by the SSA using a 5-point scale where 0=clear of unwanted redness; 1=nearly clear of unwanted redness; 2=somewhat more redness than I prefer; 3=more redness than I prefer and 4=completely unacceptable redness.|Baseline, Day 1-hour 6|Modified Intent-to-treat population consisted of all randomized patients who received study medication and who had measurements at Baseline and at least 1 post-baseline measurement for both CEA and SSA.||Percentage of responders|Participants||Number
679759|NCT01579045|Secondary|Monocular Visual Acuity in Recumbent Position|Visual Acuity measured in LogMAR units. High contrast visual acuity (VA) was measured in both eyes using a 3m LogMAR test chart at 2.5m testing distance (subsequently converted).|up to 60 minutes in recumbent position|Analysis is on those who were enrolled, randomized, and whom completed the study.||units on a scale (LogMAR)||95% Confidence Interval|Least Squares Mean
679760|NCT01579045|Primary|Lens Orientation in Recumbent Position|rotation from zero position also described as absolute value of the rotation.|up to 60 minutes in recumbent position|Subjects analyzed were those enrolled, randomized, and whom completed the study.||degrees||95% Confidence Interval|Least Squares Mean
679761|NCT01579006|Primary|Percentage of Participants on TCZ Treatment at 5-6 Months After Treatment Initiation||5-6 months|FAS population||percentage of participants||95% Confidence Interval|Number
679762|NCT01579006|Secondary|Change From Baseline in Morning Stiffness as Assessed Using VAS at Month 6|Morning stiffness was defined by the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was as limber as he/she would be during a day involving typical activities. Morning stiffness was assessed on a 100 mm VAS, where 0= none and 100= very severe.|Baseline, 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.||mm||Standard Deviation|Mean
679773|NCT01579006|Secondary|Percentage of Participants Who Achieved 20% Improvement in ACR (ACR20) Response at Month 6|ACR response was calculated based on total joint count evaluation (28 or 66/68 joint count) and other clinical and laboratory assessments. A positive ACR20 response required at least a 20% improvement (reduction) compared to baseline in swollen joint count (66 joints) and tender joint count (68 joints) and at least 3 of the following 5 assessments: participant’s global assessment of pain, PGH, PhGH (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale), participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity), Acute phase reactant (CRP or ESR). A reduction in the level of and acute phase reactants was considered an improvement.|6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.||percentage of participants|||Number
679763|NCT01579006|Secondary|Change From Administration 1 in Functional Assessment of Chronic Illness Therapy (FACIT)- Fatigue Questionnaire at Month 6|The FACIT Measurement System was a collection of health-related quality of life questionnaires targeted to the management of chronic illness and included questions on Physical Well-Being, Social/Family Well-Being, Emotional Well-Being and Functional Well-Being. The FACIT Fatigue Scale was a 13-item tool that measured an individual’s level of fatigue during their usual daily activities over the past week. The level of fatigue was measured on a five-point Likert scale (4 = not at all fatigued to 0 = very much fatigued). The total score of FACIT ranged from 0 to 160. An increase of 4 points in the FACIT-Fatigue score was considered clinically meaningful. Change from Administration 1 was reported for individual administration schedules. TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations.|Administration 1 (Baseline), 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure and “n”= participants who were evaluable for each category.||Score on a scale||Standard Deviation|Mean
679764|NCT01579006|Secondary|Change From Baseline in Participant's Assessment of RA-Related Pain at Month 6|Severity of pain was evaluated by a VAS. Participants marked on a 100 mm horizontal VAS the severity of pain that they had experienced because of their RA, ranging from 0 (no pain) to 100 (unbearable pain). A decrease of 10 points was considered clinically meaningful.|Baseline, 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.||mm||Standard Deviation|Mean
679765|NCT01579006|Secondary|Change From Baseline in Participant's Assessment of Fatigue Using VAS at Month 6|Fatigue was evaluated by a VAS. Participants marked on a 100 mm horizontal VAS the level of fatigue that they have experienced, ranging from 0 (no fatigue) to 100 (extreme fatigue).|Baseline, 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.||mm||Standard Deviation|Mean
679766|NCT01579006|Secondary|Change From Baseline in HAQ-DI at Month 6|The HAQ-DI was a participant self-reported questionnaire for assessing the extent of a participant’s functional ability. It consisted of 20 questions in 8 categories (dressing and grooming, rising, eating, walking, reach, grip, hygiene, and carrying out daily activities). Each question had 4 response options, ranging from “no difficulty” to “unable to do”, corresponding to scores from 0 to 3. The HAQ-DI scale was an average of all the scores and ranged from 0 to 3, where higher scores represented higher disease activity. A score of <0.5 represented clinical remission. A participant achieved a clinically meaningful improvement in HAQ-DI if they had a reduction from baseline of >=0.22.|Baseline, 6 months|ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.||Score on a scale||Standard Deviation|Mean
679767|NCT01579006|Secondary|Change From Baseline in PGH of Disease Activity at Month 6|"The PGH of disease activity was assessed using a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equaled 0 mm, and was described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equaled 100 mm, as maximum disease activity (maximum arthritis disease activity). A negative change from baseline indicated improvement."|Baseline, 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.||mm||Standard Deviation|Mean
679768|NCT01579006|Secondary|Change From Baseline in PhGH at Month 6|"The PhGH was assessed using a 0 to 100 mm horizontal VAS by the physician. The left-hand extreme of the line equaled 0 mm, and was described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equaled 100 mm, as maximum disease activity (maximum arthritis disease activity). A negative change from baseline indicated improvement."|Baseline, 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.||mm||Standard Deviation|Mean
679769|NCT01579006|Secondary|Change From Baseline in ESR at Month 6|ESR was a laboratory test that provided a non-specific measure of inflammation. The test assessed the rate at which red blood cells fell in a test tube. ESR was measured in mm/hr. A reduction in the level was considered an improvement.|Baseline, 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.||mm/hr||Standard Deviation|Mean
679770|NCT01579006|Secondary|Change From Baseline in CRP at Month 6|The test for CRP was a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. The serum concentration of CRP was measured in mg/dL. A reduction in the level was considered an improvement.|Baseline, 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.||mg/dL||Standard Deviation|Mean
679771|NCT01579006|Secondary|Percentage of Participants Who Achieved 70% Improvement in ACR (ACR70) Response at Month 6|ACR response was calculated based on total joint count evaluation (28 or 66/68 joint count) and other clinical and laboratory assessments. A positive ACR70 response required at least a 70% improvement (reduction) compared to baseline in swollen joint count (66 joints) and tender joint count (68 joints) and at least 3 of the following 5 assessments: (participant’s global assessment of pain, PGH, PhGH (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale), participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity), and acute phase reactant (CRP or ESR). A reduction in the level of acute phase reactants was considered an improvement.|6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.||percentage of participants|||Number
679772|NCT01579006|Secondary|Percentage of Participants Who Achieved 50% Improvement in ACR (ACR50) Response at Month 6|ACR response was calculated based on total joint count evaluation (28 or 66/68 joint count) and other clinical and laboratory assessments. A positive ACR50 response required at least a 50% improvement (reduction) compared to baseline in swollen joint count (66 joints) and tender joint count (68 joints) and at least 3 of the following 5 assessments: (participant’s global assessment of pain, PGH, PhGH (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale), participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity), and acute phase reactant (CRP or ESR). A reduction in the level of acute phase reactants was considered an improvement.|6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.||percentage of participants|||Number
679774|NCT01579006|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Month 6|The CDAI was a combined index for measuring disease activity in RA and used to evaluate disease activity in the absence of laboratory testing of CRP and ESR. It was the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PGH and PhGH (assessed on 0-100 mm); VAS (0 = no disease activity and 100 = worst disease activity). CDAI total score = 0-76. A CDAI score of <=2.8 represented clinical remission, a score of <=10.0 represented low disease activity, a score of <=22.0 represented moderate disease activity and a score of >22.0 represented high (or severe) disease.|Baseline, 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.||Score on a scale||Standard Deviation|Mean
679775|NCT01579006|Secondary|Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Month 6|The SDAI was a combined index for measuring disease activity in RA which reflected the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PGH and physician's global assessment (PhGH) of disease activity, assessed on 0-100 mm VAS where 0 = no disease activity and 100 = worst disease activity, and C-reactive protein (CRP) (milligrams per deciliter [mg/dL]). SDAI total score = 0-86. A SDAI score of <=3.3 represented clinical remission, a score of <=11.0 represents low disease activity, a score of <=26.0 represented moderate disease activity and a score of >26.0 represented high (or severe) disease.|Baseline, 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.||Score on a scale||Standard Deviation|Mean
679776|NCT01579006|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Response at Month 6|Clinical response assessed as per EULAR categorical DAS28 response criteria was defined as clinically meaningful improvement at a particular time point. EULAR response was based on change from baseline (CFB) in the DAS28 score and also on the actual DAS28 score at the time point so was more reflective of the current status of the participant. The DAS28 score was a measure of the participant's disease activity, based on the TJC (28 joints), SJC (28 joints), PGH (mm), and ESR (mm/hr). DAS28 total scores ranged from 0 to approximately 10. Scores <2.6 = best disease control and scores >5.1 = worse disease control. A negative CFB indicated clinically meaningful improvement. EULAR Good response: DAS28 <=3.2 and a CFB <-1.2. EULAR Moderate response: DAS28 >3.2 to ≤ 5.1 or a CFB < -0.6 to ≥ -1.2. EULAR No response: DAS28 ≤3.2 or CFB >=-0.6, DAS28 >3.2 to <=5.1 or CFB >=-0.6 and DAS28 >5.1 or CFB >=-0.6.|6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.||percentage of participants||95% Confidence Interval|Number
679777|NCT01579006|Secondary|Change From Baseline in Disease Activity Score Based on 28 Joints (DAS28) at Month 6|DAS28 was calculated from SJC and TJC using an assessment of 28 joints, the erythrocyte sedimentation rate (ESR) (milliliter per hour [mm/hr]), and Patient’s Global Assessment (PGH) of disease activity (measured on a 0 to 100 mm Visual Analogue Scale [VAS] where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using the following formula: DAS28 = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*PGH of disease activity. Total score range: 0-10, with a higher score indicated more disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission.|Baseline, 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.||Score on a scale||Standard Deviation|Mean
679778|NCT01579006|Secondary|Change From Baseline in Swollen Joint Count (SJC) (66 Joints) at Month 6|The number of swollen joints was recorded on the joint assessment form, with no swelling = 0, and swelling =1, for 66 joints, giving a total possible SJC score of 0 to 66.|Baseline, 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.||Swollen Joint Count||Standard Deviation|Mean
679779|NCT01579006|Secondary|Change From Baseline in Tender Joint Count (TJC) (68 Joints) at Month 6|The number of tender joints was recorded on the joint assessment form, with no tenderness = 0, and tenderness = 1, for 68 joints, giving a total possible TJC score of 0 to 68.|Baseline, 6 months|FAS population. Here, number of participants analyzed = participants with valid data to calculate TJC at the end of study (6 months).||Tender Joint Count||Standard Deviation|Mean
679780|NCT01579006|Secondary|Percentage of Participants on TCZ Monotherapy|TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations. Only those participants who had TCZ as monotherapy were reported.|Up to 6 months|FAS population. Here, “n”= participants who were evaluable for each category.||percentage of participants||95% Confidence Interval|Number
679781|NCT01579006|Secondary|Percentage of Participants Who Adhered to the Dosing Regimen Recommended by Physician|A participant's adherence was calculated based on the adverse event or laboratory abnormality experienced by the participants who required dose modifications as per local TCZ label or protocol.|6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.||percentage of participants||95% Confidence Interval|Number
679782|NCT01579006|Secondary|Time to Restoration of Initial Dosing Regimen||6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.||days||Standard Deviation|Mean
679783|NCT01579006|Secondary|Percentage of Participants Who Discontinued From TCZ for Safety Versus Efficacy|The safety variable measured the number of participants who discontinued TCZ due to adverse reactions to TCZ, and the efficacy variable measured the participants who discontinued from TCZ due to lack of efficacy according to criteria of the treating physician.|6 months|FAS population.||percentage of participants||95% Confidence Interval|Number
679784|NCT01579006|Secondary|Mean Dosing Interval of Treatment at 6 Months|TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations. The mean dosing interval between different TCZ administrations (Adm) by participants within 6 months observational period was presented.|6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure and “n”= participants who were evaluable for each category.||days||Standard Deviation|Mean
679785|NCT01579006|Secondary|Mean Number of Dose Modifications at 6 Months|TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations.|6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.||dose modification||Standard Deviation|Mean
679786|NCT01579006|Secondary|Mean Dose at 6 Months|TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations.|6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure and “n”= participants who were evaluable for each category.||milligrams per kilogram (mg/kg)||Standard Deviation|Mean
679787|NCT01579006|Secondary|Percentage of Participants With Reasons for Dose Modification|TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations. Only those participants who had dose modifications were reported.|6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.||percentage of participants||95% Confidence Interval|Number
679788|NCT01579006|Secondary|Percentage of Participants With Dose Modifications|TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations.|6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure and “n”= participants who were evaluable for each category.||percentage of participants||95% Confidence Interval|Number
679789|NCT01579006|Secondary|Percentage of Participants With Reasons for Termination of Previous Biologic RA Treatments|Lack of efficacy was determined by physician discretion. Previous biologic RA treatment included adalimumab, infliximab, golimumab, etanercept, certolizumab, and other (any other previous biologic RA treatment).|Up to 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure and “n”= participants who were evaluable for each category.||percentage of participants|||Number
679790|NCT01579006|Secondary|Duration of Previous Biologic RA Treatments|Previous biologic RA treatment included adalimumab, infliximab, golimumab, etanercept, certolizumab, and other (any other previous biologic RA treatment).|Up to 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure and “n”= participants who were evaluable for each category.||years||Standard Deviation|Mean
679791|NCT01579006|Secondary|Percentage of Participants With Type of Previous Biologic RA Treatments|Previous biologic RA treatment included adalimumab, infliximab, golimumab, etanercept, certolizumab, and other (any other previous biologic RA treatment). Same participants may be counted in more than one previous biologic RA treatment category.|Up to 6 months|FAS population.||percentage of participants|||Number
679792|NCT01579006|Secondary|Percentage of Participants Who Received Biological RA Treatment Prior to Start of Study|"Biological RA treatment exposure was evaluated for all participants. Prior biological RA treatment included participants who were treated with biological RA treatment 8 weeks before being included in the study. Percentage of participants who did not receive any biological RA treatment and percentage of participants who received one or more biologic RA treatments were reported."|Prior to study start (8 weeks)|FAS population.||percentage of participants|||Number
679793|NCT01579006|Secondary|Percentage of Participants With Reason for DMARD Withdrawal|Objective intolerance was determined by medical observation; subjective intolerance was determined by the participant; lack of efficacy was determined by physician discretion.|Up to 6 months|FAS population.||percentage of participants||95% Confidence Interval|Number
679794|NCT01579006|Secondary|Percentage of Participants Who Received DMARDs Prior to Start of Study and Concomitantly With TCZ During the Study|"DMARDs exposure was evaluated for all participants. Prior DMARDs treatment included participants, who were treated with DMARDs 8 weeks and according to physician's discretion before being included in the study. DMARDs treatment at baseline included participants who were receiving DMARDs when they were included in the study and continued with this concomitant medication in addition to TCZ. Only those participants who received DMARDs prior to start of study and at Baseline up to 6 months were reported."|Prior to study start (8 weeks) and Baseline up to 6 months|FAS population.||percentage of participants|||Number
679795|NCT01579006|Secondary|Percentage of Participants With Systemic Manifestations of RA at Baseline|Systemic manifestations included fibromyalgia, osteoporosis, sjogren’s syndrome, anemia, rheumatoid nodules, pulmonary fibrosis, vasculitis, peripheral neuropathy or mononeuropathy, scleritis, episcleritis, hypertension, hyperlipidemia, low high-density lipoproteins, diabetes type 1 and type 2, metabolic syndrome, carotid artery disease, transient ischemic attacks, embolic stroke, atherothrombotic stroke, atrial fibrillation, heart failure New York Heart Association (NYHA) Class l/ll, coronary heart disease(angina pectoris/myocardial), aortic aneurism, peripheral arterial occlusive disease, percutaneous coronary interventions, coronary artery bypass, carotid endarterectomy and peripheral arterial bypass.|Baseline|FAS population.||percentage of participants|||Number
679796|NCT01579006|Primary|Percentage of Participants on TCZ Treatment at 6 Months After Treatment Initiation||6 months|FAS population||percentage of participants||95% Confidence Interval|Number
679797|NCT01578993|Primary|Rate of PICC Line Occlusions|The incidence, severity and management of PICC line occlusions were recorded for each of the enrolled subjects.|Insertion to Removal / maximum 3 months|||percentage of enrolled subjects|||Number
679798|NCT01578980|Secondary|Frequency of Unplanned System Resets or Restarts|"Frequency of unplanned system resets or restarts
Secondary endpoints include the estimation of the failure rates of system components, frequency analysis of lost or inaccurate CGM records, and percent time of active CTR. The failure/missing data records will be compared to failure/missing data records from our past in-clinic studies."|42 hours|The three pilot subjects (one for each country) were not included in the analysis.||events per 24 hours|||Number
679799|NCT01578980|Primary|Percent Time of Active CTR|The main endpoint will be the percent time with all expected data from CGM, pump and patient manual inputs that should be available on Artificial Pancreas platform and monitoring stations. To be considered as successful, this percent time will have to reach more than 80% of total time of investigation for the entire arm.|42 hours|The three pilot subjects (one for each country) were not included in the analysis.||percentage of time of active CTR|||Number
679800|NCT01578785|Secondary|Percent Change From Baseline to Month 12 (End of Placebo Controlled Period) in Brain Volume|Brain atrophy was defined by the percent brain volume change from baseline to Month 12|Day 1 up to Month 12|Intent to treat population was planned. However analysis was not performed due to early termination of the study.|||||
679801|NCT01578785|Secondary|The Cumulative Number of Gadolinium-enhancing Lesions on T1-weighted Images Measured at Months 6 and 12 (End of Placebo Controlled Period)|Inflammatory disease activity was assessed by magnetic resonance imaging (MRI) measurement of the number of gadolinium-enhanced T1 lesions.|Day 1 up to Month 12|Intent to treat population was planned. However analysis was not performed due to early termination of the study.|||||
679802|NCT01578785|Secondary|The Cumulative Number of New or Enlarging T2 Lesions Measured at Months 6 and 12 (End of Placebo Controlled Period)|Inflammatory disease activity was assessed by magnetic resonance imaging (MRI) measurement of the number of new or newly enlarged T2 lesions.|Day 1 up to Month 12|Intent to treat population was planned. However analysis was not performed due to early termination of the study.|||||
679803|NCT01578785|Primary|The Annualized Relapse Rate During the Placebo Controlled Period|The total number of confirmed relapses during the placebo-controlled phase is divided by the sum of the number of days on study in the placebo-controlled phase and then multiplied by the number of days in the year to calculate the annualized relapse rate.|Day 1 up to Month 12|Intent to treat population was planned. However analysis was not performed due to early termination of the study.|||||
679804|NCT01578772|Primary|6-week Change in Maximum Relative Flow Mediated Dilatation (FMD) of the Brachial Artery With Telmisartan Therapy|Flow-mediated dilatation (FMD) testing of the brachial artery was performed for all participants on Telmisartan treatment at baseline and 6 weeks.|6 weeks (after baseline)|||percentage of maximum relative FMD||Inter-Quartile Range|Median
679805|NCT01578772|Primary|6-week Change in Diameter and Flow Mediated Dilatation (FMD) of the Brachial Artery With Telmisartan Therapy|Flow-mediated dilatation (FMD) testing of the brachial artery was performed for all participants on Telmisartan treatment at baseline and 6 weeks.|6 weeks (after baseline)|||mm||Inter-Quartile Range|Median
679806|NCT01578707|Secondary|Hematological Improvements||2 years||||||
679807|NCT01578707|Secondary|OS (Overall Survival)||OS analysis was conducted at the time of the interim PFS analysis, which was about 18 months after the first subject was enrolled.|||months||95% Confidence Interval|Median
679808|NCT01578707|Primary|PFS (Progression Free Survival)|"The primary objective of this study was to evaluate the efficacy of ibrutinib compared to ofatumumab based on independent review committee (IRC) assessment of progression-free survival (PFS).
Progressive disease according to 2008 IWCLL guidelines was defined as:
Group A
Lymphadenopathy, increase ≥50%
Hepatomegaly, increase ≥50%
Splenomegaly, increase ≥50%
Blood lymphocytes, increase ≥ 50% over baseline
Group B
Platelets counts, decrease of ≥ 50% from baseline secondary to CLL
Hemoglobin, decrease of > 2 g/dL from baseline secondary to CLL"|Analysis was conducted after observing approximately 117 PFS events, which occurred about 18 months after the first subject was enrolled.|||months||95% Confidence Interval|Median
679809|NCT01578330|Secondary|Mean Patient-reported Health-related Quality-of-life With Fingolimod (Short Form Health Survey: SF-36).|The SF-36v2 is a validated health-related quality of life instrument used in numerous disease states, including MS. It is a self-administered survey that measures 8 domains of health including: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems and general mental health. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). If half or more questions within a domain were answered, then a score was calculated for that domain. Otherwise, the patient score for that domain was set to missing. If the patient was missing any 1 of the 8 scale scores, then the physical and mental component scores were set to missing. An algorithm was used to create a score from 0 to 100 for each domain score and component score. A positive change from baseline indicates improvement.|Month 12|Per Protocol Population: included all patients who had evaluable data for the primary variable from first to last visit||score on scale||Standard Deviation|Mean
679810|NCT01578330|Secondary|Mean Patient-reported Health-related Quality-of-life With Fingolimod (Short Form Health Survey: SF-36).|The SF-36v2 is a validated health-related quality of life instrument used in numerous disease states, including MS. It is a self-administered survey that measures 8 domains of health including: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems and general mental health. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). If half or more questions within a domain were answered, then a score was calculated for that domain. Otherwise, the patient score for that domain was set to missing. If the patient was missing any 1 of the 8 scale scores, then the physical and mental component scores were set to missing. An algorithm was used to create a score from 0 to 100 for each domain score and component score. A positive change from baseline indicates improvement.|Month 6|Per Protocol Population: included all patients who had evaluable data for the primary variable from first to last visit||score on scale||Standard Deviation|Mean
679811|NCT01578330|Secondary|Mean Patient-reported Health-related Quality-of-life With Fingolimod (Short Form Health Survey: SF-36).|The SF-36v2 is a validated health-related quality of life instrument used in numerous disease states, including MS. It is a self-administered survey that measures 8 domains of health including: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems and general mental health. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). If half or more questions within a domain were answered, then a score was calculated for that domain. Otherwise, the patient score for that domain was set to missing. If the patient was missing any 1 of the 8 scale scores, then the physical and mental component scores were set to missing. An algorithm was used to create a score from 0 to 100 for each domain score and component score. A positive change from baseline indicates improvement.|Month 1|Per Protocol Population: included all patients who had evaluable data for the primary variable from first to last visit||score on scale||Standard Deviation|Mean
679824|NCT01578031|Primary|Change From Baseline in Mean Arterial Blood Pressure|Change in mean 24-hour ambulatory blood pressure from baseline following 4-months of PAP treatment|4 months|||mm Hg||Inter-Quartile Range|Mean
679825|NCT01577966|Primary|Percent Decrease in Central Nervous System Bioavailability of Sulfasalazine|To determine the ability of sulfasalazine to alter glioma glutamate levels. These levels will be measured by Magnetic Resonance Spectroscopy (MRS). The percent change is noted per subject. The measure is a % decrease of glioma glutamate levels|up to 2 years post baseline|||percentage of change|||Number
679812|NCT01578330|Primary|Mean Patient-Reported Treatment Satisfaction Questionnaire for Medication Scores (TSQM-9)|The Treatment Satisfaction Questionnaire for Medication (TSQM-9) is a psychometric measure of a patient's satisfaction with medication. It consists of 3 subscales: effectiveness, convenience and global satisfaction. The scores were computed by adding items for each domain, i.e. 1 to 3 for effectiveness, 4 - 6 for convenience and 7 to 9 for global satisfaction. The lowest possible score (1 for each item and 3 for all 3 subscales) was subtracted from the composite score and divided by the greatest possible score range. The greatest range was (7-1) X 3 items = 18 for the effectiveness and convenience, and (5-1) x 3 items = 12 for global satisfaction. This provided a transformed score between 0 and 1 that was then multiplied by 100. A positive change from baseline indicates improvement.|Baseline and month 12|Per Protocol Population: included all patients who had evaluable data for the primary variable from first to last visit||Scores on a scale||Standard Deviation|Mean
679813|NCT01578239|Other Pre-specified|Exploratory Objectives|"To explore the correlation of toxicity outcomes and administered radioactivity corrected for body weight and body surface area;
To explore the correlation of clinical efficacy outcomes with the levels of the biomarkers Chromogranin-A (CgA) in the serum and 5-Hydroxyindoleacetic acid (5-HIAA) in the urine;
To evaluate dosimetry, pharmacokinetics (PK) and ECG in a subset of 20 patients;
To explore the correlation of clinical efficacy outcomes with OctreoScan® tumour uptake score;
To explore the correlation of clinical outcomes with serum levels of Alkaline Phosphatase (AP):
To evaluate the Duration of Response (DoR) in the two study arms;
To evaluate the Time to Second Progression (PFS2) in the two study arms"|Study Treatment Phase||||||
679814|NCT01578239|Secondary|Long-term Safety and Efficacy Assessment|"Any progressive patient ceases treatment/assessment and proceeds to long-term follow-up assessment.
Any non-progressive patients continues treatment/assessments until the PFS Primary End-Point, then:
Patients who have 76week or more treatment/assessment stop treatment but continue the long-term follow-up assessments for 5 years overall from the date of randomization of the last randomized.
Remaining randomized patients continue in the fixed 76-week treatment/assessment phase unless progression occurs, then proceed to the long-term follow-up assessment phase for 5 years overall from the date of randomization of the last randomized patient.
During the long-term follow-up assessment phase, toxicities suspected in relation with the study drug (including haematology, biochemistry, urine analyses), anti-tumour treatment administered after progression/discontinuation, disease status based on local CT/MRI assessment, and OS data will be collected every 6 months."|Every 6 months for a period of up to 5 years after the end of the study||||||
679815|NCT01578239|Secondary|Safety Assessments (Adverse Events, Laboratory Parameters, Cancer Related Symptoms, Physical Examination, Vital Signs, Karnofsky Performance Status, ECG)|"The following parameters will be monitored:
Changes from Baseline in Hematology (WBC, platelets, haemoglobin, MCV), Blood chemistry (BUN, serum creatinine and creatinine clearance, uric acid, albumin, total bilirubin, AP, aspartate aminotransferase [AST/ASAT], alanine aminotransferase [ALT/ALAT], gamma-glutamyl transferase [γ-GT], [Na], [K], lactic dehydrogenase [LDH], glycosylated hemoglobin/hemoglobin A1c [glycoHb], free thyroxine [fT4]) and Urinalysis (RBC/hpf, WBC/hpf, casts/lpf, protein, 5-HIAA),
Cancer related symptoms,
Physical Examination, including heart rate, blood pressure and weight,
Karnofsky Performance Status,
ECG intervals.
All AEs and SAEs reported (spontaneously or not) by the patient will be collected during the study."|Treatment emergent adverse events collected from date of first enrollment (10 Jul 2012) to 30 June 2016 are reported.||||||
679816|NCT01578239|Primary|Progression Free Survival (PFS)|"Primary efficacy endpoint is PFS as measured by objective tumour response, centrally assessed according to RECIST Criteria.
CT/MRI tumour assessment in both arms will be performed every 12±1 weeks from the first treatment date."|after 74 centrally confirmed cases disease progression or death|Full analysis data set||months||95% Confidence Interval|Median
679817|NCT01578187|Primary|Percentage of Participants Performing Critical/Non-critical Errors|"Study staff will record the number of errors according to the following:
Critical error: an error that may cause a serious adverse event or an adverse event from a single occurrence
Non critical error: An error that, if repeated without correction/intervention, may cause an adverse event."|1-2 hours|Subjects who were not self-excluders in the label comprehension phase and consented to continue to the usability phase (product use).||percentage of participants with errors|||Number
679818|NCT01578187|Primary|Percent of Participants Correctly Determining Eligibility for Use of the Device (Responders)|"Label comprehension will be based on responses to a questionnaire. Questions will be based on a tiered system by level of importance in responding correctly according to the following:
Questions regarding safe use of the system.
Questions regarding correct use of the system(not related to safety).
In order to demonstrate how well the label instruction, as a whole, was understood by all subjects, the proportion of subjects who correctly understood the label as a whole was calculated by classifying each subject as either a “responder or non-responder” based on the following criteria regarding all questions:
A subject was considered a responder if he/she correctly answered 11/12 questions related to safety AND 5/6 low category questions not related to safety.
The study was considered a success if the response rate (i.e., the proportion of subjects correctly understanding the label based on the responder criteria) was at least 90%."|1 hour|Sample size was discussed with the FDA during a pre-IDE teleconference||percentage of participants|||Number
679819|NCT01578044|Primary|Gaps Days Between Prescription Refills for Dabigatran, Rivaroxaban, and Apixaban|The investigators will calculate the # of gap days between refills for dabigatran/rivaroxaban/apixaban for each3 and 6 months of the pilot intervention. This will be based on pharmacy refill data and calculated using the date dabigatran/rivaroxaban/apixaban was dispensed and the # of days supplied for that prescription. We will add the # of gap days for each 3 and 6 months of the pilot for each patient, and compare the total # of gaps days between intervention and usual care patients. The gap days between refills is a validated measure of adherence and identifies patients with sub-optimal adherence.A negative gap day value indicates that participants received the refill prior to completion of the previous prescription.|3 and 6 months|||days|||Number
679820|NCT01578031|Secondary|Change From Baseline in Oxidative Stress|Overnight urinary excretion of 8-isoprostane.|4 months||||||
679821|NCT01578031|Secondary|Change From Baseline in Circulating Inflammatory Biomarkers|Circulating IL-6, CRP, and other circulating inflammatory biomarkers.|4 months||||||
679822|NCT01578031|Secondary|Change From Baseline in Sympathetic Nervous System Activity|24-hour urine collection for catecholamine levels.|4 months||||||
679823|NCT01578031|Secondary|Change From Baseline in Psychomotor Vigilance Task|Reaction time test.|4 months||||||
679826|NCT01577758|Primary|AUC0-21 Days: Area Under the Curve Day 0 to Day 21 for MMAE|Area under the plasma drug concentration versus time curve from time 0 to Day 21. AUC0-21 is reported for the 1.8 mg/kg dose (the MTD), where there is adequate data to provide robust parameter information reliably.|Cycle 1: Day 1 pre-dose to 21 Days post-dose|Participants from the PK-evaluable Population, all participants with sufficient dosing and reliable PK data to estimate PK parameter AUC0-21 days.||day*ng/mL||Full Range|Geometric Mean
679827|NCT01577758|Primary|AUC0-21 Days: Area Under the Curve Day 0 to Day 21 for MLN0246|Area under the drug concentration versus time curve from time 0 to Day 21. AUC0-21 is reported for the 1.8 mg/kg dose (the MTD), where there is adequate data to provide robust parameter information reliably.|Cycle 1: Day 1 pre-dose to 21 Days post-dose|Participants from the PK-evaluable Population, all participants with sufficient dosing and reliable PK data to estimate PK parameters.||day*μg/mL||Full Range|Geometric Mean
679828|NCT01577758|Primary|Cmax: Maximum Observed Plasma Concentration for Monomethyl Auristatin E (MMAE)|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. Cmax is reported for the 1.8 mg/kg dose, which is the MTD, where there is adequate data to provide robust parameter information reliably.|Cycle 1: Day 1 pre-dose to Day 21 post-dose|Participants from the Pharmacokinetic (PK)-evaluable Population, all participants with sufficient dosing and reliable PK data to estimate PK parameters.||ng/mL||Full Range|Geometric Mean
679829|NCT01577758|Primary|Cmax: Maximum Observed Serum Concentration for MLN0264|Maximum observed serum concentration (Cmax) is the peak serum concentration of a drug after administration, obtained directly from the serum concentration-time curve. Cmax is reported for the 1.8 mg/kg dose, which is the MTD, where there is adequate data to provide robust parameter information reliably.|Cycle 1: Day 1 pre-dose to Day 21 post-dose|Participants from the Pharmacokinetic (PK)-evaluable Population, all participants with sufficient dosing and reliable PK data to estimate PK parameters.||μg/mL||Full Range|Geometric Mean
679830|NCT01577758|Secondary|Number of Participants With Antitherapeutic Antibodies (ATA)|Blood was collected and sent to a laboratory to determine the immunogenicity, whether binding antibodies to MLN0264 were present (ATA development).|Day 1 of every 21 days cycle and at End of study (EOS) approximately 9 months|||participants|||Number
679831|NCT01577758|Secondary|Best Overall Response|"The percentage of participants in each best overall response category, was determined using the Modified Response Evaluation Criteria in Solid Tumors (RECIST).
Complete Response: Disappearance of all target lesions and all non-target lesions and normalization of tumor marker level.
Partial Response: At least a 30% decrease in the sum of the Longest Diameter (LD) of target lesions, taking as reference the baseline sum LD.
Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the start or the appearance of one or more new lesions. Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Stable Disease: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD. Persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits."|At the completion of every second cycle up to 12 cycles (approximately 9 months). Each cycle is a 21 days cycle|Response Evaluable Population is defined as patients with measureable disease who receive any amount of MLN0264 and have at least 1 post-Baseline response assessment.||percentage of participants|||Number
679832|NCT01577758|Primary|Maximum Tolerated Dose (MTD) of MLN0264|MTD of MLN0264 was determined. Decisions regarding dose escalation were made based on any DLT that occurred during the first cycle of treatment.|Every 3 weeks until MTD is established, approximately 9 months|DLT evaluable Population: participants enrolled in the Dose Escalation phase of the study who either experienced a DLT during Cycle 1 or received a scheduled Cycle 1 dose and completed all study procedures in Cycle 1 without DLT.||mg/kg|||Number
679833|NCT01577758|Primary|Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events|"An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug.
A Serious Adverse Event (SAE) was any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug."|From the time informed consent is signed through 30 days after the last dose of study drug, approximately 9 months|Safety Analysis Set included all participants who received at least one dose of study drug.||participants|||Number
679834|NCT01577758|Primary|Number of Participants With Dose-Limiting Toxicities (DLTs)|"DLT was defined as any of the following Adverse Events (AEs) that occur and are considered by the investigator to be related to therapy.
Grade 4 neutropenia (Absolute Neutrophil Count < 500 cells/mm^3).
Grade 3 or greater neutropenia with fever and/or infection.
Grade 4 thrombocytopenia (platelets < 25,000/mm^3).
Grade 3 or greater thrombocytopenia with clinically meaningful bleeding at any time.
Grade 3 or greater nausea and/or emesis that occurs despite of prophylaxis.
Grade 3 or greater diarrhea that occurs despite supportive care.
Any other Grade 3 or greater non-hematological toxicity other than Grade 3 fatigue or Grade 3 Alopecia.
Inability to start the next cycle of therapy due to treatment delay of more than 2 weeks because of lack of recovery.
Other MLN0264-related non-hematologic toxicities Grade 2 or greater requiring discontinuation of therapy."|From the time informed consent is signed through 30 days after the last dose of study drug, approximately 9 months|DLT evaluable Population: participants enrolled in the Dose Escalation phase of the study who either experienced a DLT during Cycle 1 or received a scheduled Cycle 1 dose and completed all study procedures in Cycle 1 without DLT.||participants|||Number
679835|NCT01577745|Secondary|Overall Survival|Overall survival defined as the time from the first dose of MEDI0639 until death due to any cause. OS (months) = (Date of death or censoring – Date of the first dose of MEDI0639 + 1) / (365.25/12).|From study entry through the end of the study. Maximum time frame across participants was 4 years.|All participants who received at least one dose of MEDI0639.||Months||95% Confidence Interval|Median
679836|NCT01577745|Secondary|Progression-free Survival (PFS)|Progression-free survival (PFS) is defined as the time from the first dose of MEDI0639 until the first documentation of disease progression or death due to any cause, whichever occurs first. PFS (months) = (Date of PD/death or censoring – Date of the first dose of MEDI0639 + 1) / (365.25/12).|From study entry through the end of the study. Maximum time frame across participants was 4 years.|All participants who received at least one dose of MEDI0639.||Months||95% Confidence Interval|Median
679837|NCT01577745|Secondary|Duration of Response (DR)|DR defined as time from start of first documented objective response [confirmed Complete Response (CR) or confirmed Partial Response (PR)] to first documented disease progression or death due to any cause, whichever occurs first. DR calculated as (months) = (Date of PD/death or censoring – Date of first disease response + 1)/ (365.25/12).|From study entry through the end of the study. Maximum time frame across participants was 4 years.|All participants who received at least one dose of MEDI0639. All participants with an objective response were included.||Months||95% Confidence Interval|Median
679838|NCT01577745|Secondary|Time to Response|Time to response (TTR) defined as the time from the first dose of MEDI0639 until the first documentation of a subsequently confirmed objective response. Only participants who have achieved objective response (confirmed CR or confirmed PR) was evaluated for TTR. TTR (months) = (Date of first disease response – Date of the first dose of MEDI0639 + 1) / (365.25/12).|From study entry through the end of the study. Maximum time frame across participants was 4 years.|All participants who received at least one dose of MEDI0639. All participants with an objective response were included.||Months||95% Confidence Interval|Median
679839|NCT01577745|Secondary|Percentage of Participants With Disease Control|Disease control rate (DCR) defined as the percentage of participants with a BOR of confirmed CR, confirmed PR or SD.|From study entry through the end of the study. Maximum time frame across participants was 4 years.|All participants who received at least one dose of MEDI0639.||Percentage of Participants||95% Confidence Interval|Number
679840|NCT01577745|Secondary|Percentage of Participants With Objective Response|Objective response rate (ORR) defined as the percentage of participants with a BOR of confirmed CR or confirmed PR.|From study entry through the end of the study. Maximum time frame across participants was 4 years.|All participants who received at least one dose of MEDI0639. All participants with an objective response were included.||Percentage of Participants||95% Confidence Interval|Number
679841|NCT01577745|Secondary|Percentage of Participants With Best Overall Response|Percentage (%) of participants who were responders with BOR documented as confirmed CR, PR, stable disease (SD), progressive disease (PD) and non-evaluable (NE). CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 mm. PR: At least a 30 % decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.|From study entry through the end of the study. Maximum time frame across participants was 4 years.|All participants who received at least one dose of MEDI0639.||Percentage of Participants|||Number
679842|NCT01577745|Secondary|Number of Participants Positive With Antidrug Antibodies (ADA) for MEDI0639|Blood samples were measured for the presence of ADA for MEDI0639 using a validated bridging immunoassay. Only the number of participants positive for anti-MEDI-575 antibodies at any visit were presented.|On Day 1 of Cycles 1, 2, 3, and every other cycle thereafter, end of treatment, 30 days, and 3 and 6 months after the last dose of MEDI0639. Maximum time frame across participants was 14 months.|All participants who received any treatment with MEDI0639.||Participants|||Number
679843|NCT01577745|Secondary|Half-life (t1/2) After Cycle 1 Treatment Administration of MEDI0639|The pharmacokinetics (PK) parameter was estimated using the noncompartmental analysis methods, based on the individual serum concentration-time data. The concentration-time curve is the result of blood sampling at specified time points and its measured concentration of MEDI0639.|Days 1 (prior to start of infusion and 30 mins, 2, and 6 hours post end of infusion), 2, 5 , 8, and 15 of Cycle 1|All the participants who received dose of MEDI0639 in Cycle 1 and for whom PK blood samples were collected and evaluated.||Days||Standard Deviation|Mean
679844|NCT01577745|Secondary|Clearance (CL) After Cycle 1 Treatment Administration of MEDI0639|The pharmacokinetics (PK) parameter was estimated using the noncompartmental analysis methods, based on the individual serum concentration-time data. The concentration-time curve is the result of blood sampling at specified time points and its measured concentration of MEDI0639. Clearance was estimated as dose divided by the area under serum concentration-time curve from time zero to infinity.|Days 1 (prior to start of infusion and 30 mins, 2, and 6 hours post end of infusion), 2, 5 , 8, and 15 of Cycle 1|All the participants who received dose of MEDI0639 in Cycle 1 and for whom PK blood samples were collected and evaluated.||Liter per day (L/d)||Standard Deviation|Mean
679845|NCT01577745|Secondary|Maximum Observed Concentration (Cmax) After Cycle 1 Treatment Administration of MEDI0639|The pharmacokinetics (PK) parameter was estimated using the noncompartmental analysis methods, based on the individual serum concentration-time data. The concentration-time curve is the result of blood sampling at specified time points and its measured concentration of MEDI0639.|Days 1 (prior to start of infusion and 30 mins, 2, and 6 hours post end of infusion), 2, 5 , 8, and 15 of Cycle 1|All the participants who received dose of MEDI0639 in Cycle 1 and for whom PK blood samples were collected and evaluated.||microgram per milliliter (mcg/mL)||Standard Deviation|Mean
679846|NCT01577745|Secondary|Area Under the Concentration‑Time Curve From Time 0 to Infinity (AUCinf) After Cycle 1 Treatment Administration of MEDI0639|The pharmacokinetics (PK) parameter was estimated using the noncompartmental analysis methods, based on the individual serum concentration-time data. The concentration-time curve is the result of blood sampling at specified time points and its measured concentration of MEDI0639.|Days 1 (prior to start of infusion and 30 mins, 2, and 6 hours post end of infusion), 2, 5 , 8, and 15 of Cycle 1|All the participants who received dose of MEDI0639 in Cycle 1 and for whom Pharmacokinetic (PK) blood samples were collected and evaluated.||microgram*day per milliliter (mcg*d/mL)||Standard Deviation|Mean
679847|NCT01577745|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Echocardiogram Evaluations|Echocardiogram parameters included left ventricular ejection fraction (LVEF) and pulmonary arterial pressure (PAP). The TEAEs related to echocardiogram evaluations in participants were reported.|From the first dose of MEDI0639 until 90 days after last dose of MEDI0639. Maximum time frame across participants was 11 months.|All participants who received at least one dose of MEDI0639.||Participants|||Number
679848|NCT01577745|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Electrocardiogram (ECG) Evaluations|ECG parameters included QT interval and corrected QT (QTc) interval. Electrocardiogram (ECG) parameters were assessed at baseline as well as throughout the study. All 12-lead ECGs performed during the study were obtained in triplicate. The TEAEs related to ECG evaluations in participants were reported.|From the first dose of MEDI0639 until 90 days after last dose of MEDI0639. Maximum time frame across participants was 11 months.|All participants who received at least one dose of MEDI0639.||Participants|||Number
679849|NCT01577745|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Vital Signs and Physical Examination|Vital signs (temperature, blood pressure, pulse rate, and respiratory rate) were performed at baseline and throughout the study. The TEAEs related to vital signs in participants were reported.|From the first dose of MEDI0639 until 90 days after last dose of MEDI0639. Maximum time frame across participants was 11 months.|All participants who received at least one dose of MEDI0639.||Participants|||Number
679850|NCT01577745|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Laboratory Parameters|Laboratory evaluations of blood and urine samples were performed, including hematology (white blood cell [WBC] count with differential, red blood cell [RBC] count, hematocrit, hemoglobin, platelet count, mean corpuscular volume [MCV], and mean corpuscular hemoglobin concentration [MCHC]); serum chemistry (calcium, chloride, magnesium, potassium, sodium, bicarbonate, aspartate transaminase [AST], alanine transaminase [ALT], alkaline phosphatase, total bilirubin, liver function test, gamma glutamyl transferase [GGT], lactate dehydrogenase, uric acid, creatinine, blood urea nitrogen [BUN], glucose, albumin, total protein, triglycerides, cholesterol, and troponin); and routine urinalysis. The TEAEs related to laboratory evaluations in participants were reported.|From the first dose of MEDI0639 until 90 days after last dose of MEDI0639. Maximum time frame across participants was 11 months.|All participants who received at least one dose of MEDI0639.||Participants|||Number
679851|NCT01577745|Primary|Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)|A serious AE (SAE) is any AE that results in death (refers to an event, which risk of death at the time of the event; it does not refer to an event that may have led to death), is immediately life threatening, require (or prolong) inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event that may jeopardize the participant or may require medical intervention to prevent one of the outcomes listed above. Treatment-emergent SAEs defined as SAEs present at baseline that worsened in intensity after administration of study drug or SAEs absent at baseline that emerged after administration of study drug. The SAEs were summarized using MedDRA version 18.1.|From the first dose of MEDI0639 until the end of participation in the study. Maximum time frame across participants was 4 years.|All participants who received at least one dose of MEDI0639.||Participants|||Number
679852|NCT01577745|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs)|An adverse event (AE) is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the study drug. Treatment-emergent AEs (TEAEs) were events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug, for the period extending to 90 days after the last dose of study drug. The AEs were summarized using Medical Dictionary for Regulatory Activities (MedDRA) version 18.1.|From the first dose of MEDI0639 until 90 days after the last dose of MEDI0639. Maximum time frame across participants was 11 months.|All participants who received at least one dose of MEDI0639.||participants|||Number
679853|NCT01577745|Primary|Maximum Tolerated Dose (MTD) of MEDI0639|The MTD evaluation was based on the dose-limiting toxicity (DLT) evaluable population. DLT is defined as any Grade 3 or higher treatment-related toxicity that occurred during the DLT evaluation period (defined as the time from the first dose of MEDI0639 to 21 days after the first dose), except for National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 hypertension that could be controlled within 96 hours; Grade 3 symptomatic hypertension of greater than (>) 180 millimetre of mercury (mm Hg) systolic or >120 mm Hg diastolic or asymptomatic hypertension of >200 mm Hg systolic or >120 mm Hg diastolic was considered a DLT.|From the first dose of MEDI0639 to 21 days after the first dose|All participants enrolled in the dose-escalation phase who received at least 1 full cycle of MEDI0639 and completed safety follow-up through the DLT evaluation period or experienced any DLT.||milligram (mg)|||Number
679854|NCT01577732|Primary|Number of Subjects Reporting Any Serious Adverse Events (SAEs).|SAEs assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Any SAE = any SAE regardless of assessment of relationship to study vaccination.|During the entire study period (Days 0-30).|Analyses were performed on the Total Vaccinated cohort, which included all the subjects with documented administration of the study vaccine.||Subjects|||Number
679855|NCT01577732|Primary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).|An unsolicited AE was any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an AE regardless of intensity grade or relationship to study vaccination.|Within the 31-day (Days 0-30) follow up period after vaccination.|Analyses were performed on the Total Vaccinated cohort, which included all the subjects with documented administration of the study vaccine.||Subjects|||Number
679869|NCT01577628|Secondary|Influence of the Presence of Mutation in the Filaggrin Gene on the Proportion of Infants Who Develop a Food Allergy|Influence of the presence of mutation in the filaggrin gene on the proportion of infants who develop a food allergy at two years for infants randomized to Lipikar Balm AP as compared to infants randomized to the no intervention control group|2 years|Subjects were not randomized to either treatment prior to study termination and therefore no data was collected for this Outcome Measure|||||
679856|NCT01577732|Primary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed were Drowsiness, Irritability/Fussiness, Loss of Appetite and Fever, defined as axillary temperature higher than (>) 37.5 degrees Celsius (°C). Any = occurrence of a general symptom regardless of intensity grade or relationship to study vaccination.|Within the 4-day (Days 0-3) follow up period after vaccination.|Analyses were performed on the Total Vaccinated cohort, which included all the subjects with documented administration of the study vaccine.||Subjects|||Number
679857|NCT01577732|Primary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.|Within the 4-day (Days 0-3) follow up period after vaccination.|Analyses were performed on the Total Vaccinated cohort, which included all the subjects with documented administration of the study vaccine.||Subjects|||Number
679858|NCT01577706|Primary|Right Temporal: Percent Change in GABA Levels After an Acute Drug Challenge|"The primary goal of this study is to assess the efficacy of an advanced spectroscopic imaging protocol in detecting changes in the levels of brain GABA in response to an acute drug challenge.
GABA levels are expressed as a ratio to total creatinine: GABA/Cr percent change = 100*(later timepoint - earlier timepoint) / earlier timepoint"|from 45 minutes post-dose to 102 minutes post-dose in 19-minute intervals (4 time points at t1: 45, t2: 64, t3: 83, t4: 102 minutes post-dose)|One participant is missing GABA level at t4 while on Dextroamphetamine. Another participant is missing GABA levels both at t2 and t4 while on Dextroamphetamine. Another participant is missing GABA levels at both t2 and t4 while on Alprazolam.||percent change||Inter-Quartile Range|Median
679859|NCT01577706|Primary|Right Basal-Ganglia: Percent Change in GABA Levels After an Acute Drug Challenge|"The primary goal of this study is to assess the efficacy of an advanced spectroscopic imaging protocol in detecting changes in the levels of brain GABA in response to an acute drug challenge.
GABA levels are expressed as a ratio to total creatinine: GABA/Cr percent change = 100*(later timepoint - earlier timepoint) / earlier timepoint"|from 45 minutes post-dose to 102 minutes post-dose in 19-minute intervals (4 time points at t1: 45, t2: 64, t3: 83, t4: 102 minutes post-dose)|One participant is missing GABA level at t4 while on Dextroamphetamine.||percent change||Inter-Quartile Range|Median
679860|NCT01577706|Primary|Right Thalamus: Percent Change in GABA Levels After an Acute Drug Challenge|"The primary goal of this study is to assess the efficacy of an advanced spectroscopic imaging protocol in detecting changes in the levels of brain GABA in response to an acute drug challenge.
GABA levels are expressed as a ratio to total creatinine: GABA/Cr percent change = 100*(later timepoint - earlier timepoint) / earlier timepoint"|from 45 minutes post-dose to 102 minutes post-dose in 19-minute intervals (4 time points at t1: 45, t2: 64, t3: 83, t4: 102 minutes post-dose)|One participant ismissing GABA level at t4 while on Dextroamphetamine||percent change||Inter-Quartile Range|Median
679861|NCT01577706|Primary|Parieto-Occipital: Percent Change in GABA Levels After an Acute Drug Challenge|"The primary goal of this study is to assess the efficacy of an advanced spectroscopic imaging protocol in detecting changes in the levels of brain GABA in response to an acute drug challenge.
GABA levels are expressed as a ratio to total creatinine: GABA/Cr percent change = 100*(later timepoint - earlier timepoint) / earlier timepoint"|from 45 minutes post-dose to 102 minutes post-dose in 19-minute intervals (4 time points at t1: 45, t2: 64, t3: 83, t4: 102 minutes post-dose)|||percent change||Inter-Quartile Range|Median
679862|NCT01577706|Primary|Left Temporal: Percent Change in GABA Levels After an Acute Drug Challenge|"The primary goal of this study is to assess the efficacy of an advanced spectroscopic imaging protocol in detecting changes in the levels of brain GABA in response to an acute drug challenge.
GABA levels are expressed as a ratio to total creatinine: GABA/Cr percent change = 100*(later timepoint - earlier timepoint) / earlier timepoint"|from 45 minutes post-dose to 102 minutes post-dose in 19-minute intervals (4 time points at t1: 45, t2: 64, t3: 83, t4: 102 minutes post-dose)|One participant is missing GABA level at t4 while on Placebo, and one participant is missing GABA level at t2 while on Alprazolam.||percent change||Inter-Quartile Range|Median
679863|NCT01577706|Primary|Left Basal-Ganglia: Percent Change in GABA Levels After an Acute Drug Challenge|"The primary goal of this study is to assess the efficacy of an advanced spectroscopic imaging protocol in detecting changes in the levels of brain GABA in response to an acute drug challenge.
GABA levels are expressed as a ratio to total creatinine: GABA/Cr percent change = 100*(later timepoint - earlier timepoint) / earlier timepoint"|from 45 minutes post-dose to 102 minutes post-dose in 19-minute intervals (4 time points at t1: 45, t2: 64, t3: 83, t4: 102 minutes post-dose)|||percent change||Inter-Quartile Range|Median
679864|NCT01577706|Primary|Left Thalamus: Percent Change in GABA Levels After an Acute Drug Challenge|"The primary goal of this study is to assess the efficacy of an advanced spectroscopic imaging protocol in detecting changes in the levels of brain GABA in response to an acute drug challenge.
GABA levels are expressed as a ratio to total creatinine: GABA/Cr percent change = 100*(later timepoint - earlier timepoint) / earlier timepoint"|from 45 minutes post-dose to 102 minutes post-dose in 19-minute intervals (4 time points at t1: 45, t2: 64, t3: 83, t4: 102 minutes post-dose)|||percent change||Inter-Quartile Range|Median
679865|NCT01577628|Secondary|Time of Onset of Atopic Dermatitis|Time of onset of atopic dermatitis in infants randomized to Lipikar Balm AP as compared to infants randomized to the no intervention control group|2 years|Subjects were not randomized to either treatment prior to study termination and therefore no data was collected for this Outcome Measure|||||
679866|NCT01577628|Secondary|Adverse Events (AEs) Collection|Adverse events (Skin AEs, asthma, food allergies, allergic rhinitis and any AE related to Lipikar Syndet, Lipikar Balm AP (group 1) or any other moisturizer application (group 2) will be collected.|2 years|Subjects were not randomized to either treatment prior to study termination and therefore no data was collected for this Outcome Measure|||||
679867|NCT01577628|Secondary|Time of Onset of Food Allergy in Infants|Time of onset of food allergy in infants randomized to Lipikar Balm AP as compared to infants randomized to the no intervention control group|2 years|Subjects were not randomized to either treatment prior to study termination and therefore no data was collected for this Outcome Measure|||||
679868|NCT01577628|Secondary|Time of Onset of Asthma in Infants|Time of onset of asthma in infants randomized to Lipikar Balm AP as compared to infants randomized to the no intervention control group|2 years|Subjects were not randomized to either treatment prior to study termination and therefore no data was collected for this Outcome Measure|||||
679953|NCT01576159|Primary|Changes in Serum COMP Accumulation, Triggered by Acute Exercise, After 12 Weeks of Different Regular Exercises||Baseline and 12 weeks|||U/l||Standard Deviation|Mean
679870|NCT01577628|Secondary|Influence of the Presence of Mutation in the Filaggrin Gene on the Proportion of Infants Who Develop Asthma|Influence of the presence of mutation in the filaggrin gene on the proportion of infants who develop asthma at two years for infants randomized to Lipikar Balm AP as compared to infants randomized to the no intervention control group|2 years|Subjects were not randomized to either treatment prior to study termination and therefore no data was collected for this Outcome Measure|||||
679871|NCT01577628|Secondary|Influence of the Presence of Mutation in the Filaggrin Gene on the Proportion of Infants Who Develop Atopic Dermatitis|Influence of the presence of mutation in the filaggrin gene on the proportion of infants who develop atopic dermatitis at two years for infants randomized to Lipikar Balm AP as compared to infants randomized to the no intervention control group|2 years|Subjects were not randomized to either treatment prior to study termination and therefore no data was collected for this Outcome Measure|||||
679872|NCT01577628|Secondary|Proportion of Infants Who Develop a Food Allergy|Proportion of infants who develop a food allergy at two years for infants randomized to Lipikar Balm AP as compared to infants randomized to the no intervention control group|2 years|Subjects were not randomized to either treatment prior to study termination and therefore no data was collected for this Outcome Measure|||||
679873|NCT01577628|Secondary|Proportion of Infants Who Develop Asthma|Proportion of infants who develop asthma at two years for infants randomized to Lipikar Balm AP as compared to infants randomized to the no intervention control group|2 years|Subjects were not randomized to either treatment prior to study termination and therefore no data was collected for this Outcome Measure|||||
679874|NCT01577628|Primary|Proportion of Infants Who Develop Atopic Dermatitis|Proportion of infants who develop atopic dermatitis at two years for infants randomized to Lipikar Balm AP as compared to infants randomized to the no intervention control group|2 years|Subjects were not randomized to either treatment prior to study termination and therefore no data was collected for this Outcome Measure|||||
679875|NCT01577381|Secondary|Change From Baseline in Amyloid Beta (A-Beta) 1-42 Plasma Concentration at End of Study (Day 449)|Concentration of amino acid peptide, known as A-Beta 1-42, in plasma.|Baseline, Day 449|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).|||||
679876|NCT01577381|Secondary|Change From Baseline in Amyloid Beta (A-Beta) 1-40 Plasma Concentration at End of Study (Day 449)|Concentration of amino acid peptide, known as A-Beta 1-40, in plasma.|Baseline, Day 449|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).|||||
679877|NCT01577381|Secondary|Change From Baseline in Total Amyloid Beta (A-Beta) 1-x Plasma Concentration at End of Study (Day 449)|Concentration of total amino acid peptide, known as A-Beta 1-x, in plasma.|Baseline, Day 449|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).|||||
679878|NCT01577381|Secondary|Plasma Population PK Parameters|Population PK parameters were to be evaluated for Cmax, AUCt, Cmin, CLss, and Rac for AUCt between the first and last (11th) doses.|Days 1, 28, 57, 85, 169, 253, 281, 309, 337 and 449|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).|||||
679879|NCT01577381|Secondary|Accumulation Ratio (Rac) for AUCt||Days 1, 28,57, 85, 169, 253, 281, 309, 337, and 449|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).|||||
679880|NCT01577381|Secondary|Clearance at Steady State (CLss)|Steady state total body clearance equals infusion rate (zero order) divided by steady state plasma concentration of study drug (R0/Css)|Days 1, 28,57, 85, 169, 253, 281, 309, 337, and 449|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).|||||
679881|NCT01577381|Secondary|Area Under the Concentration-Time Curve From Time Zero Until Last Sampling Time (AUCt)||Days 1, 28,57, 85, 169, 253, 281, 309, 337, and 449|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).|||||
679882|NCT01577381|Secondary|Minimum Observed Plasma Trough Concentration (Cmin)||Days 1, 28,57, 85, 169, 253, 281, 309, 337, and 449|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).|||||
679883|NCT01577381|Secondary|Maximum Observed Plasma Concentration (Cmax)||Days 1, 28,57, 85, 169, 253, 281, 309, 337, and 449|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).|||||
679884|NCT01577381|Secondary|Number of Participants With Treatment-Related TEAEs|An AE was an untoward medical occurrence in a participant who received study drug without regard to causal relationship. An investigator's relationship assessment is the determination of whether there exists a reasonable possibility that the investigational product caused or contributed to an AE.|Days 28, 57, 85, 113, 141 and 169|The safety analysis set included all participants who received at least one dose of study product.||Participants|||Number
679885|NCT01577381|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) According to Seriousness|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Seriousness of an AE was assessed under the criteria of serious adverse event (SAE). An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Days 28, 57, 85, 113, 141 and 169|The safety analysis set included all participants who received at least 1 dose of study drug.||Participants|||Number
679886|NCT01577381|Secondary|Number of Participants With Positive Anti-Drug Antibody (ADA)|The number of participants with positive ADA was to be summarized for each treatment arm.|Day 57 and Day 169|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).|||||
679887|NCT01577381|Secondary|Number of Participants With Clinically Significant Treatment-Emergent Electrocardiogram (ECG) Findings|Clinically significant ECG findings include: corrected QT (QTc) > 450 msec, QTc >500 msec, change in QTc between 30 and 60 msec, change in QTc greater than or equal to 60 msec.|Days 28, 57, 85, 113 and 169|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).|||||
679888|NCT01577381|Secondary|Number of Participants With Abnormal Change From Baseline in Vital Signs|Vital sign assessments include: supine systolic and diastolic blood pressure, pulse rate and body temperature.|Screening, Days 28, 57, 85, 113, 141, and 169|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).|||||
679889|NCT01577381|Secondary|Number of Participants With Treatment-Emergent Laboratory Abnormalities|Laboratory assessments include: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen, creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid albumin, total protein); coagulation assessments.|Day 85 and Day 169|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).|||||
679890|NCT01577381|Secondary|Change From Placebo in Critical Print Size Reading at 9, 12, 15 Months and End of Study|The critical print size is the smallest print size at which participants can read with their maximum reading speed.|Baseline, Month 9, Month 12, Month 15, and End of Study|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).|||||
679891|NCT01577381|Secondary|Change From Baseline in Critical Print Size Reading at 9, 12, 15 Months and End of Study|The critical print size is the smallest print size at which participants can read with their maximum reading speed.|Baseline, Month 9, Month 12, Month 15, and End of Study|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).|||||
679892|NCT01577381|Secondary|Percentage Change From Baseline in Reading Acuity at 9, 12, 15 Months and End of Study|Reading Acuity was measured using the Radner reading charts and expressed in terms of logRAD.|Baseline, Month 9, Month 12, Month 15, and End of Study|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).|||||
679893|NCT01577381|Secondary|Change From Placebo in Reading Acuity at 9, 12, 15 Months and End of Study|Reading Acuity was measured using the Radner reading charts and expressed in terms of logRAD.|Baseline, Month 9, Month 12, Month 15, and End of Study|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).|||||
679894|NCT01577381|Secondary|Change From Baseline in Reading Acuity at 9, 12, 15 Months and End of Study|Reading Acuity was measured using the Radner reading charts and expressed in terms of logRAD (logrithmic Reading Acuity Determination).|Baseline, Month 9, Month 12, Month 15, and End of Study|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).|||||
679895|NCT01577381|Secondary|Percentage Change From Baseline in Reading Speed at 9, 12, 15 Months and End of Study|Reading speed in the study eye was assessed using modified Bailey-Lovie word charts. Participants read the chart for 2 minutes and the number of words read correctly per minute was totaled. An increase in the number of words read correctly indicated an improvement and a decrease in the number of words read correctly indicated a worsening.|Baseline, Month 9, Month 12, Month 15, and End of Study|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).|||||
679896|NCT01577381|Secondary|Change From Placebo in Reading Speed at 9, 12, 15 Months and End of Study|Reading speed in the study eye was assessed using modified Bailey-Lovie word charts. Participants read the chart for 2 minutes and the number of words read correctly per minute was totaled. An increase in the number of words read correctly indicated an improvement and a decrease in the number of words read correctly indicated a worsening.|Baseline, Month 9, Month 12, Month 15, and End of Study|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).|||||
679897|NCT01577381|Secondary|Change From Baseline in Reading Speed at 9, 12, 15 Months and End of Study|Reading speed in the study eye was assessed using modified Bailey-Lovie word charts. Participants read the chart for 2 minutes and the number of words read correctly per minute was totaled. An increase in the number of words read correctly indicated an improvement and a decrease in the number of words read correctly indicated a worsening.|Baseline, Month 9, Month 12, Month 15, and End of Study|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).|||||
679898|NCT01577381|Secondary|Percentage Change From Baseline in Contrast Sensitivity at 9, 12, 15 Months and End of Study|Contrast sensitivity was measured using the Pelli-Robson chart at 1 meter. Subjects were tested for contrast sensitivity using +0.50 addition over the protocol refraction providing the best-corrected distance VA. Contrast sensitivity was recorded as the log of the faintest triplet for which 2 of the 3 letters were read correctly.|Baseline, Month 9, Month 12, Month 15, and End of Study|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).|||||
679899|NCT01577381|Secondary|Change From Baseline in Contrast Sensitivity at 9, 12, 15 Months and End of Study|Contrast sensitivity was measured using the Pelli-Robson chart at 1 meter. Participants were tested for contrast sensitivity using +0.50 addition over the protocol refraction providing the best-corrected distance VA. Contrast sensitivity was recorded as the log of the faintest triplet for which 2 of the 3 letters were read correctly.|Baseline, Month 9, Month 12, Month 15, and End of Study|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).|||||
679900|NCT01577381|Secondary|Percentage Change From Baseline in LL-BCVA Correct Number of Lines at 9, 12, 15 Months and End of Study|LL-BCVA is the measure of visual acuity under low light conditions.|Baseline, Month 9, Month 12, Month 15, and End of Study|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).|||||
679901|NCT01577381|Secondary|Percentage Change From Baseline in LL-BCVA Correct Number of Letters at 9, 12, 15 Months and End of Study|LL-BCVA is the measure of visual acuity under low light conditions.|Baseline, Month 9, Month 12, Month 15, and End of Study|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).|||||
679902|NCT01577381|Secondary|Mean Low Luminance Best Corrected Visual Acuity (LL-BCVA) at 9, 12, 15 Months and End of Study|LL-BCVA is the measure of visual acuity under low light conditions.|Baseline, Month 9, Month 12, Month 15, and End of Study|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).|||||
679903|NCT01577381|Secondary|Percentage Change From Baseline in BCVA Correct Number of Lines at Months 9, 12, 15 Months and End of Study|BCVA is measured using an eye chart and is reported as the number of lines read correctly in the study eye. The lower the number of lines read correctly on the eye chart, the worse the vision (or visual acuity).|Baseline, Month 9, Month 12, Month 15, and End of Study|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).|||||
679904|NCT01577381|Secondary|Percentage Change From Baseline in BCVA Correct Number of Letters at 9, 12, 15 Months and End of Study|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity).|Baseline, Month 9, Month 12, Month 15, and End of Study|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).|||||
679905|NCT01577381|Secondary|Mean Best Corrected Visual Acuity (BCVA) at 9, 12, 15 Months and End of Study|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity).|Baseline, Month 9, Month 12, Month 15, and End of Study|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).|||||
679906|NCT01577381|Primary|Mean Reduction (in Study Eye) in Rate of Growth of GA at Day 449 (End of Study)|GA is the advanced form of dry AMD. The reduction in GA area in the study eye was based on FAF at end of study (Day 449).|Baseline and Day 449|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).|||||
679907|NCT01577381|Primary|Mean Reduction (in Study Eye) in Rate of Growth of Geographic Atrophy (GA) at Day 309|GA is the advanced form of dry age-related macular degeneration (AMD). The reduction in GA area of the study eye was based on Fundus Autofluorescence (FAF) at 30 days post last dose administration (Day 309).|Baseline and Day 309|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).|||||
679908|NCT01577329|Primary|Changes in Respiratory Rate|Breathing patterns will be measured at baseline using inductive plethysmography at baseline and at week eight. During that eight week time period the treatment group will have been exposed to a once a week mindfulness meditation class and the control group will have been exposed to health care as usual.|baseline and at week eight|||Breaths per minute||Standard Deviation|Mean
679909|NCT01577186|Other Pre-specified|Change From Baseline in Total Personal and Social Performance (PSP) Score at Week 12|The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty).|Baseline, Week 12|ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here, 'n' signifies those participants who were evaluable for this outcome measure at specified time point.||units on a scale||Standard Deviation|Mean
679910|NCT01577186|Other Pre-specified|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 12|The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent) to 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity.|Baseline, Week 12|ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here, 'n' signifies those participants who were evaluable for this outcome measure at specified time point.||units on a scale||Standard Deviation|Mean
679911|NCT01577186|Primary|Percentage of Participants Achieving Improvement in Personal and Social Performance (PSP) Score by at Least One Category on PSP Scale|The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty). Percentage of participants achieving improvement in PSP score by at least one category was reported.|End of study (Up to Week 12)|ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment.||percentage of participants||95% Confidence Interval|Number
679912|NCT01577186|Secondary|Social Functioning Scale (SFS) Score|The SFS is a 36-item scale designed to assess social functioning in schizophrenia. It assesses abilities and performance in seven areas: social engagement, interpersonal communication, activities of daily living, recreation, social activities, competence at independent living, and occupation/employment. Total score ranges from 1 to 100 where higher score indicates a more favorable health state.|End of study (Up to Week 12)|ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
679913|NCT01577186|Primary|Percentage of Participants Achieving Symptomatic Remission by Means of Positive and Negative Syndrome Scale (PANSS)|The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self). The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent), 2 (minimal), 3 (mild), 4 (moderate), 5 (moderately severe), 6 (severe) and 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity. Symptomatic remission was defined as achieving intensity level of mild or moderate on PANSS scale by all 8 items as the determinants for symptomatic remission: delusions, unusual thought content, hallucinatory behavior, conceptual disorganization, mannerisms/posturing, blunted affect, social withdrawal, lack of spontaneity.|End of study (Up to Week 12)|Intent-to-treat (ITT) population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment.||percentage of participants||95% Confidence Interval|Number
679914|NCT01577160|Secondary|Change From Baseline in Drug Attitude Inventory (DAI-10) Score at Week 12|The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. It is the binary scale assessing the participant's subjective response (SR). A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive SR; a negative sum of scores indicates a negative SR (non-compliant). The final score is the grand total of the positive and negative points. Total score ranges from (-) 10 to (+) 10, higher score indicates positive SR (compliant) and lower score indicates negative SR (non-compliant).|Baseline, Week 12|ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here, 'n' signifies those participants who were evaluable for this outcome measure at specified time point.||units on a scale||Standard Deviation|Mean
679915|NCT01577160|Secondary|Change From Baseline in Personal and Social Performance (PSP) Score at Week 12|The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty).|Baseline, Week 12|ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here, 'n' signifies those participants who were evaluable for this outcome measure at specified time point.||units on a scale||Standard Deviation|Mean
679916|NCT01577160|Secondary|Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score|The CGI-I is a 7-point scale that requires the clinician to assess how much the participant’s illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.|Week 12|ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here 'N' (Number of Participants Analyzed) signifies those participants evaluable for this measure.||participants|||Number
679917|NCT01577160|Secondary|Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 12|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher scores indicate worsening."|Baseline, Week 12|ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here, 'n' signifies those participants who were evaluable for this outcome measure at specified time point.||units on a scale||Standard Deviation|Mean
679918|NCT01577160|Primary|Percentage of Responders as Per Clinical Global Impression - Improvement (CGI-I) Scale|The CGI-I is a 7-point scale that requires the clinician to assess how much the participant’s illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. Responders were defined as participants evaluated as “1: very much improved” or “2: much improved” on the CGI-I scale at Week 12.|Week 12|Intent-to-treat (ITT) population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here 'N' (Number of Participants Analyzed) signifies those participants evaluable for this measure.||percentage of participants||95% Confidence Interval|Number
679919|NCT01577108|Primary|Number of GBS-Positive Pregnant Women Who Became GBS-Negative at Childbirth|To exam the GBS colonization in both vagina and rectum when childbirth. The purpose of this study is to examine whether oral taking Lactobacillus-containing probiotics can reduce the GBS colonization rate of vagina and rectum in pregnant women who present with GBS-positive.|2 weeks after taking probiotic|The GBS colonization results changed from positive to negative in 21 women in the probiotic group (42.9%) and in nine women in the placebo group (18.0%) during this period.||Participants|||Count of Participants
679920|NCT01576952|Primary|Ocular Inflammation|"Anterior chamber cell grade 0 at Day 15 measured on a 0 to 4 scale where 0 is 0 cells; 1 is 1-10 cells; 2 is 11-20 cells; 3 is 21-50 cells; 4 is > 50 cells, and no rescue medications."|15 days|Modified Intent-to-Treat (ITT) Population using Last Observation Carried Forward (LOCF) method.||participants|||Number
679921|NCT01576939|Secondary|How Does Increase in Pain Scores Affect Quality of Life Questionnaire While Adjusting for the Measured Lateral Tongue Mucosal Dose?|"The quality of life questionnaire was the HNC adaptation of the Oral Mucositis Daily Questionnaire (OMDQ). It is designed to assess the severity and impact of the oral mucositis by evaluating mouth and throat soreness and the degree to which the mouth and throat soreness interferes with activities of daily life such as eating, swallowing, drinking, talking and sleeping.
This outcome measures pain in the mouth only.
This outcome is not a combination of several sub-scales. This outcome was the response to a single question: On a scale from 0 to 10, what number best describes the MOUTH PAIN that you experienced in the past 24 hours?
Mouth pain scale was measured as a single scale from 0 (no pain) to 10 (worst pain imaginable)."|3 years|Only 29 out of the 30 subjects filled out the pain surveys||units on pain scale||95% Confidence Interval|Mean
679922|NCT01576939|Secondary|How Does Increase in Soreness Scores Affect Quality of Life Questionnaire While Adjusting for the Measured Lateral Tongue Mucosal Dose|"The quality of life questionnaire was the HNC adaptation of the Oral Mucositis Daily Questionnaire (OMWQ). It is designed to assess the severity and impact of the oral mucositis by evaluating mouth and throat soreness and the degree to which the mouth and throat soreness interferes with activities of daily life such as eating, swallowing, drinking, talking and sleeping.
This outcome measures soreness in both the mouth and throat.
This outcome is not a combination of several sub-scales. This outcome was the response to the single question: On a scale from 0 to 10, how would you rate your OVERALL MOUTH AND THROAT SORENESS during the past 24 hours?
Mouth and throat soreness was measured as a single scale from 0 (no soreness) to 10 (worst soreness possible)."|3 years|||units on soreness scale||95% Confidence Interval|Mean
679923|NCT01576939|Secondary|Relationship Between the Measured Lateral Tongue Mucosal Dose and the Amount of Narcotic Use|The narcotics use was a patient reported measurement that was documented in the medical note in the patient chart. Patient self reported measurements are generally known to be unreliable.|3 years|||mg||95% Confidence Interval|Mean
679924|NCT01576939|Primary|Duration of Grade 2 or Higher Oral Mucositis After First Oral Mucositis Was Observed.|"The duration of grade 2 or higher oral mucositis was measured as the time from the first time oral mucositis was observed by a clinician at the weekly checkup until the oral mucositis was resolved.
The data was analyzed in a mixed effects model to account for the within subject correlation, since each patient contributed two measurements to the data set. The model was limited to those subjects who had experienced mucositis and then the outcome was the duration of grade 2 or higher mucositis. This allowed us to model the data in a mixed effects model with the continuous outcome of duration of grade 2 or higher mucositis."|3 years|For each subject, both left and right sides were included as two measurements from the same individual.||Days||95% Confidence Interval|Mean
679925|NCT01576939|Primary|Time Until the Maximum Oral Mucositis Measured From the Start of Radiation Treatment.|"The time to onset of oral mucositis was measured from the start of radiation treatment until oral mucositis was visual observed by a clinician during the weekly checkup for the first time. Analysis done by Kaplan-Meier.
Adverse events were graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version (V) 4.0. Medical doctor performed evaluation and grading of clinical and functional mucositis for the measured site weekly during the radiation treatment course and biweekly after completion of radiation until oral mucositis was < grade 2. A pain medication assessment was done for each mucositis time point. Patients completed the Oral Mucositis Weekly Questionnaire-Head and Neck cancer (OMWQ-HN) during and after treatment until oral mucositis is < grade 2."|3 years|The entire cohort was analyzed||Days||95% Confidence Interval|Median
679926|NCT01576809|Secondary|Safety and Tolerability of the Syrup|Number of participants with adverse events.|1 hour|||participants|||Number
679927|NCT01576809|Secondary|Subject Acceptability of the Syrup|"In response to the question How did you like the warming sensation you have experienced for this product?, the number of patients answering Like extremely or Like very much or Like moderately or Like slightly
Possible responses are :
Like extremely Like very much Like moderately Like slightly Neither like nor dislike Dislike slightly Dislike moderately Dislike very much Dislike extremely"|1 hour|||participants|||Number
679928|NCT01576809|Primary|Warming Sensation Caused by the Excipient IFF Flavor 316 282, in a Syrup Containing Paracetamol 500 mg + Phenylephrine 10mg + Guaifenesin 200 mg Per 30 ml Syrup|Intensity of warming sensation felt by subjects between predose to 1 minute postdose where 0= no warming sensation and 100= strongest possible warming sensation|1 minutes|||mm||Standard Deviation|Mean
679929|NCT01576718|Other Pre-specified|Change From Baseline In Weekly Average Of Daily Trough (Predose And Pre-Rescue Bronchodilator) Evening Peak Expiratory Flow (PEF) Over The 12-Week Treatment Period (Including the Flovent Diskus Treatment Arm)|"Peak expiratory flow was determined in the AM and in the PM, before administration of study or rescue medications using a handheld electronic peak flow meter. The highest value of triplicate measurements obtained was recorded by the subject’s diary device.
PM PEF baseline was defined as the average of recorded (nonmissing) PM PEF assessments over the 7 days directly preceding first study drug intake.
The p-values for the treatment comparisons to Flovent Diskus are from an MMRM model that included data for all treatments: change from baseline = baseline PEF + sex + age + treatment + visit + treatment*visit with an unstructured covariance matrix assumed."|Baseline (Days -6 to Day 1 pre-dose), Weeks 1, 2, 3, 4, 6, 8, 10 and 12|Full analysis set, including participants who contributed at least once to the analysis. Based on blinded data review, data from one site are excluded due to good clinical practice (GCP) concerns.||liters/minute||Standard Error|Least Squares Mean
679930|NCT01576718|Other Pre-specified|Change From Baseline In Weekly Average Of Daily Trough (Predose And Pre-Rescue Bronchodilator) Morning Peak Expiratory Flow (PEF) Over The 12-Week Treatment Period (Including the Flovent Diskus Treatment Arm)|"Peak expiratory flow was determined in the AM and in the PM, before administration of study or rescue medications using a handheld electronic peak flow meter. The highest value of triplicate measurements obtained was recorded by the subject’s diary device.
On mornings for which a treatment visit was scheduled (TV1 through TV9), the PEF was measured and recorded at the investigational site visit.
Baseline trough AM PEF was defined as the average of recorded (nonmissing) trough AM PEF assessments over the 7 days directly preceding first study drug intake.
The p-values for the treatment comparisons to Flovent Diskus are from an MMRM model that included data for all treatments: change from baseline = baseline PEF + sex + age + treatment + visit + treatment*visit with an unstructured covariance matrix assumed."|Baseline (Days -6 to Day 1 pre-dose), Weeks 1, 2, 3, 4, 6, 8, 10 and 12|Full analysis set, including participants who contributed at least once to the analysis. Based on blinded data review, data from one site are excluded due to good clinical practice (GCP) concerns.||liters/minute||Standard Error|Least Squares Mean
679931|NCT01576718|Other Pre-specified|Change From Baseline In Trough (Morning Predose And Pre-Rescue Bronchodilator) Forced Expiratory Volume In 1 Second (FEV1) Over The 12-Week Treatment Period (Including the Flovent Diskus Treatment Arm)|"Peak expiratory flow was determined in the AM and in the PM, before administration of study or rescue medications using a handheld electronic peak flow meter. The highest value of triplicate measurements obtained was recorded by the subject’s diary device.
On mornings for which a treatment visit was scheduled (TV1 through TV9), the PEF was measured and recorded at the investigational site visit.
Baseline trough AM PEF was defined as the average of recorded (nonmissing) trough AM PEF assessments over the 7 days directly preceding first study drug intake.
The p-values for the treatment comparisons to Flovent Diskus are from an MMRM model which includes data from all treatments: change from baseline = baseline PEF + sex + age + treatment + visit + treatment*visit with an unstructured covariance matrix assumed."|Baseline (Day 1 pre-dose), Weeks 1, 2, 3, 4, 6, 8, 10 and 12|Full analysis set, including participants who contributed at least once to the analysis. Based on blinded data review, data from one site are excluded due to good clinical practice (GCP) concerns.||liters||Standard Error|Least Squares Mean
679932|NCT01576718|Secondary|24-Hour Urinary Cortisol Excretion at Baseline, Week 12 and Endpoint|24-hour urinary cortisol excretion was determined from 24-hour pooled-urine samples; urine was refrigerated until return to the investigational site after each 24-hour collection period. Urine was collected within 7 days of Day 1 and within 7 days of Week 12. Urine cortisol sample collection was not required at endpoint visit for subjects who terminated early from the study.|Baseline (Day 1), Week 12, Endpoint|Urine cortisol analysis set||nmol/day||Standard Deviation|Mean
679933|NCT01576718|Secondary|Patients With Positive Swab Test Results for Oral Candidiasis|"Oropharyngeal examinations for visual evidence of oral candidiasis were conducted at each visit. Any visual evidence of oral candidiasis during the oropharyngeal exam was evaluated by obtaining and analyzing a swab of the suspect area.
This outcomes indicates how many patients had positive swab test results. The total number of patients who had oropharyngeal exams at each timepoint are specified in the timepoint field. Appropriate therapy was to be initiated immediately at the discretion of the investigator and was not to be delayed for culture confirmation. Subjects with a culture-positive infection could continue participation in the study on appropriate anti-infective therapy, provided this therapy was not prohibited by the protocol."|Screening (Days -21 to -14), Randomization (Day 1), Weeks 1, 2, 3, 4, 6, 8, 10, 12|Safety analysis set||participants|||Number
679934|NCT01576718|Secondary|Patients With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period|An adverse event was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relationship of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 to Week 12|Safety analysis set||participants|||Number
679935|NCT01576718|Secondary|Time Of Maximum Observed Plasma Concentration (Tmax)||Day 1 predose (within 10 minutes of treatment administration), and 5, 10, 15, 30, and 45 minutes, 1 hour, 1 hour 15 minutes, 1 hour 30 minutes, and 2, 4, 8, and 12 hours postdose|Pharmacokinetic analysis set. Two participants in the Fp MDPI 100 mcg treatment arm did not have AUC data. PK tests not run on participants in the Placebo MDPI arm.||hours||Standard Deviation|Mean
679936|NCT01576718|Secondary|Maximum Observed Plasma Concentration (Cmax)||Day 1 predose (within 10 minutes of treatment administration), and 5, 10, 15, 30, and 45 minutes, 1 hour, 1 hour 15 minutes, 1 hour 30 minutes, and 2, 4, 8, and 12 hours postdose|Pharmacokinetic analysis set. Two participants in the Fp MDPI 100 mcg treatment arm did not have AUC data. PK tests not run on participants in the Placebo MDPI arm.||pg/mL||Standard Deviation|Mean
679937|NCT01576718|Secondary|Area Under The Plasma Concentration-Time Curve From Time Zero To The Time Of The Last Measurable Concentration (AUC0-t)||Day 1 predose (within 10 minutes of treatment administration), and 5, 10, 15, 30, and 45 minutes, 1 hour, 1 hour 15 minutes, 1 hour 30 minutes, and 2, 4, 8, and 12 hours postdose|Pharmacokinetic analysis set. Two participants in the Fp MDPI 100 mcg treatment arm did not have AUC data. PK tests not run on participants in the Placebo MDPI arm.||pg*hr/mL||Standard Deviation|Mean
679938|NCT01576718|Secondary|Change From Baseline In The Percentage Of Rescue-Free 24-Hour Periods|"The change from baseline in the percentage of rescue-free 24-hour periods was analyzed with a marginal (also called population averaged) logistic model, with the response being the proportion of rescue-free 24-hour periods. The model included 2 time points of measurement for each subject: the baseline (the last 7 days before the treatment period) and the treatment period. The model contained covariates for sex, age, and treatment. Rescue-free days were as indicated in patient diaries.
Data values are estimated means."|Baseline (Day -6 to Day 1 predose), Treatment (Day 1 to Week 12)|Full analysis set including participants who contributed at least once to the analysis.||percentage of total 24 hour periods||Standard Error|Mean
679939|NCT01576718|Secondary|The Kaplan-Meier Estimate Of The Probability Of Remaining In The Study At Week 12|"The analysis of probability of remaining in the study at Week 12 used the time to patient withdrawal for worsening asthma. Worsening asthma was defined as:
clinic visit FEV1 below the FEV1 stability limit value calculated on Day 1.
any 7-day run-in or treatment window (using information from the patient diary) during which the subject experienced:
3 or more days in which the highest PEF has fallen below the PEF stability limit calculated on Day 1
3 or more days in which ≥12 inhalations/day of albuterol/salbutamol was used
2 or more days in which the subject experienced a nighttime asthma symptom score of >2
clinical asthma exacerbation, defined as worsening asthma requiring any treatment other than study drug or rescue albuterol/salbutamol including the use of systemic corticosteroids and/or ER visit or hospitalization.
Patients who had withdrawn due to reasons other than worsening asthma were right-censored at the date of last assessment."|Day 1 to Week 12|Full analysis set||probability||95% Confidence Interval|Number
679940|NCT01576718|Secondary|Change From Baseline In Weekly Average Of Daily Trough (Predose And Pre-Rescue Bronchodilator) Evening Peak Expiratory Flow (PEF) Over The 12-Week Treatment Period|"Peak expiratory flow was determined in the AM and in the PM, before administration of study or rescue medications using a handheld electronic peak flow meter. The highest value of triplicate measurements obtained was recorded by the subject’s diary device.
PM PEF baseline was defined as the average of recorded (nonmissing) PM PEF assessments over the 7 days directly preceding first study drug intake.
The p-values for the treatment comparisons to placebo are from an MMRM model excluding FLOVENT DISKUS data: change from baseline = baseline PEF + sex + age + treatment + visit + treatment*visit with an unstructured covariance matrix assumed."|Baseline (Days -6 to Day 1 pre-dose), Weeks 1, 2, 3, 4, 6, 8, 10 and 12|Full analysis set, including participants who contributed at least once to the analysis. Based on blinded data review, data from one site are excluded due to good clinical practice (GCP) concerns. Flovent Diskus data was used for confirmatory and exploratory endpoints; evening PEF data for Flovent Diskus is reported in outcome #14.||liters/minute||Standard Error|Least Squares Mean
679954|NCT01576146|Secondary|Percent Change From Baseline in Serum Phosphorus|"Baseline was defined as the average of 3 predialysis results obtained within 3 weeks before the first dose of study drug in the parent study (20120331).
The week numbering for this study continued from the parent study 20120331; the first measurement for all parameters in the extension study started at week 13."|Baseline and Weeks 13, 26 and 52|The full analysis set (all participants who received at least 1 dose during the extension study) with data collected on or before the last non-missing dose of etelcalcetide (defined as on-treatment approach).||percent change||Standard Error|Mean
679941|NCT01576718|Secondary|Change From Baseline In Weekly Average Of Daily Trough (Predose And Pre-Rescue Bronchodilator) Morning Peak Expiratory Flow (PEF) Over The 12-Week Treatment Period|"Peak expiratory flow was determined in the AM and in the PM, before administration of study or rescue medications using a handheld electronic peak flow meter. The highest value of triplicate measurements obtained was recorded by the subject’s diary device.
On mornings for which a treatment visit was scheduled (TV1 through TV9), the PEF was measured and recorded at the investigational site visit.
Baseline trough AM PEF was defined as the average of recorded (non-missing) trough AM PEF assessments over the 7 days directly preceding first study drug intake.
The p-values for the treatment comparisons to placebo are from an MMRM model excluding FLOVENT DISKUS data: change from baseline = baseline PEF + sex + age + treatment + visit + treatment*visit with an unstructured covariance matrix assumed."|Baseline (Days -6 to Day 1 pre-dose), Weeks 1, 2, 3, 4, 6, 8, 10 and 12|Full analysis set, including participants who contributed at least once to the analysis. Based on blinded data review, data from one site are excluded due to good clinical practice (GCP) concerns. Flovent Diskus data was used for confirmatory and exploratory endpoints; morning PEF data for Flovent Diskus is reported in outcome #13.||liters/minute||Standard Error|Least Squares Mean
679942|NCT01576718|Primary|Change From Baseline In Trough (Morning Predose And Pre-Rescue Bronchodilator) Forced Expiratory Volume In 1 Second (FEV1) Over The 12-Week Treatment Period|"Trough FEV1 was measured electronically by spirometry at morning (AM) investigational site visits, before administration of the AM dose of study drug, and before albuterol/salbutamol administration. The highest FEV1 value from 3 acceptable and 2 reproducible maneuvers was used. All FEV1 data were submitted to a central reading center for evaluation.
The p-values for the treatment comparisons to placebo are from an MMRM model excluding FLOVENT DISKUS data: change from baseline = baseline FEV1 + sex + age + treatment + visit + treatment*visit with an unstructured covariance matrix assumed."|Baseline (Day 1 pre-dose), Weeks 1, 2, 3, 4, 6, 8, 10 and 12|Full analysis set, including participants who contributed at least once to the analysis. Based on blinded data review, data from one site are excluded due to good clinical practice (GCP) concerns. Flovent Diskus data was used for confirmatory and exploratory endpoints; FEV1 data for Flovent Diskus is reported in outcome #12.||liters||Standard Error|Least Squares Mean
679943|NCT01576471|Primary|Evaluate the Effects of TSO on the Induction of Response in Crohn's Disease, as Measured Primarily by Crohn's Disease Activity Index (CDAI)|CDAI >= 100 point reduction from baseline|12 weeks|all patients randomized and treated with at least 1 dose of study medication||Participants|||Count of Participants
679944|NCT01576367|Secondary|Number of Vaccination Cases With Protective Antibody Levels Following Immunization With Inactivated Vaccines|Participants who received any inactivated vaccines during the study were assessed for their ability to attain protective antibody levels against the vaccine (antigen) post immunization. Participants vaccinations were not assessed for a response if the antibody titre was already sufficient at pre-dose and maintained during the study.|pre-vaccine dose, Day 28 post-vaccine|"Extension Full analysis set (FAS) consisted of all patients who received at least one dose of study drug in the extension study. Out of 20 unique patient-vaccination cases, 17 cases were assessable for a vaccination response whereas for the remaining 3 cases no pre-dose antibody titer was available,"||vaccination cases|Participants||Number
679945|NCT01576367|Secondary|Frequency Counts of Physician’s Global Assessment of Autoinflammatory Disease and Skin Disease|Participants were assessed based by physician on Physician's Global Assessment measured on a 5­-point scale for auto inflammatory disease activity as: 0 = None/absent; 1 = Minimal; 2 = Mild; 3 = Moderate; 4 = Severe|minimum of 6 months and maximum of 24 months|Extension Full analysis set (FAS) consisted of all patients who received at least one dose of study drug in the extension study||Percentage of participants|||Number
679946|NCT01576367|Secondary|Change From Baseline (Core Study Baseline) in C­-Reactive Protein (CRP) and Serum Amyloid A (SAA) Concentrations|CRP and SAA were used as serologic inflammatory markers. The target level concentrations for CRP and SAA was ≤15 mg/L and ≤10 mg/L, respectively. Negative change in concentration of inflammatory markers indicated improvement.|Week 0, 80, 104, 128 and 152, last assessment|Extension Full analysis set (FAS) consisted of all patients who received at least one dose of study drug in the extension study||(mg/L)||Standard Deviation|Mean
679947|NCT01576367|Secondary|Immunogenicity of Canakinumab (ACZ885). Number of Participants With Anti-canakinumab Antibodies|Immunogenicity assessment included determination of anti-canakinumab (ACZ885) antibodies in serum samples using BIAcore system, with detection based on surface plasmon resonance technique.|minimum of 6 months and maximum of 24 months|Extension Safety set consisted of all patients from the core study who received at least one dose of study drug in the extension study and had at least one post-treatment safety assessment. Of note, the statement that a patient had no AE also constituted a safety assessment.||Participants|||Number
679948|NCT01576367|Primary|The Percentage of Participants Without Disease Relapse as Determined by the Physician's Global Assessment of Autoinflammatory Disease Activity, Assessment of Skin Disease and Serological Inflammation Markers.|Disease relapse following complete response is defined as inflammation markers: C-Reactive Protein (CRP) and/or Serum Amyloid A (SAA) result > 30 mg/L AND Physician's Global Assessment of Autoinflammatory Disease Activity > minimal or Physician's Global Assessment >= minimal AND Skin Disease Assessment > minimal. Physician's Global Assessment of Autoinflammatory Disease Activity and Skin Disease Assessment (urticarial skin rash) are completed by the investigator using a 5 point rating scale: absent, minimal, mild, moderate and severe.|Week /80, 104, 128, and 152 (A minimum of 6 months and maximum of 24 months)|Extension Full analysis set (FAS) consisted of all patients who received at least one dose of study drug in the extension study||Percentage of participants|||Number
679949|NCT01576341|Secondary|Hemoglobin Level and Change From Baseline Period at Visit 16 (End of Study)|Actual values of hemoglobin levels at end of study visit and change from Baseline Period (Week -4 to Week -1)|52 weeks|Per-protocol population (all patients that received at least one dose of study drug) with non-missing Hemoglobin value at Visit 16 (end of study).||g/dL||Standard Deviation|Mean
679950|NCT01576341|Primary|Anti-Erythropoietin (EPO) Antibodies|The incidence of antibody formation against epoetin in Radio-immuno-precipitation (RIP) assay|52 weeks|Safety population: The safety population consists of all patients that received at least one dose of study drug||percentage of participants||95% Confidence Interval|Number
679951|NCT01576159|Secondary|Physiological (Maximum Oxygen Consumption) Changes of Participants||Baseline and 12 weeks|||ml/kg/min||Standard Deviation|Mean
679952|NCT01576159|Secondary|Physical (Body Mass Index) Changes of Participants||Baseline and 12 weeks|||kg/m^2||Standard Deviation|Mean
679955|NCT01576146|Secondary|Percent Change From Baseline in Serum Corrected Calcium|"Baseline was defined as the average of 3 predialysis results obtained within 3 weeks before the first dose of study drug in the parent study (20120331).
The week numbering for this study continued from the parent study 20120331; the first measurement for all parameters in the extension study started at week 13."|Baseline and Weeks 13, 26 and 52|The full analysis set (all participants who received at least 1 dose during the extension study) with data collected on or before the last non-missing dose of etelcalcetide (defined as on-treatment approach).||percent change||Standard Error|Mean
679956|NCT01576146|Secondary|Percent Change From Baseline in Parathyroid Hormone|"Baseline was defined as the average of 3 predialysis results obtained within 3 weeks before the first dose of etelcalcetide in the parent study (20120331).
The week numbering for this study continued from the parent study 20120331 hence the first measurement for all parameters in the extension study started at week 13."|Baseline (of the parent study 20120331) and Weeks 13, 26 and 52|The full analysis set (all participants who received at least 1 dose during the extension study) with data collected on or before the last non-missing dose of etelcalcetide (defined as on-treatment approach).||percent change||Standard Error|Mean
679957|NCT01576146|Primary|Number of Participants With Adverse Events||From the first dose of study drug in the parent study (20120331) through 30 days after the last dose in the extension study; actual median duration of treatment was 439 days.|Participants who received at least one dose of etelcalcetide in the extension study||participants|||Number
679958|NCT01576120|Primary|• Evaluate the Effectiveness of the PillCam COLON 2 Bowel Prep Regimen in Crohn's Disease Patients|"effectiveness of the PillCam COLON 2 bowel prep regimen in Crohn's Disease patients will be evaluated by the folloiwng: • Bowel preparation cleansing level assessment
The duration of the procedure in this study is 1 day of colon preparation and
1 day of Capsule Endoscopy (CE) procedure. 5-9 days after the CE procedure a follow up call to the subjects will be conducted."|The end points and outcomes measures will be evaluated within 4 months from end of enrollment|||percentage of adequate cleansing||95% Confidence Interval|Number
679963|NCT01576042|Secondary|Number of Participants Received Treatment Assigned|Records participants who received study randomized treatment during the study|6 months|||participants|||Number
679964|NCT01576042|Secondary|Time to First Recurrent ICD Therapy for VT|Days from the date of the first study treatment to the date of first ICD recurrent therapy for VT.|Baseline, 6 months|||Days||Standard Deviation|Mean
679965|NCT01576042|Secondary|Number of Participants Switched to Other Arm|Records participants who received study treatment as randomized and later switched to other treatment arm during the study|6 months|||participants|||Number
679966|NCT01576042|Secondary|Number of Participants Remained on Randomized Treatment Assignment|Records participants who only received study treatment as randomized during the entire study|6 month|||participants|||Number
679967|NCT01576042|Secondary|Cardiovascular Hospitalizations|Records participants hospitalized for VT during the study|Baseline, 6 months|||participants|||Number
679968|NCT01576042|Secondary|Number of Participants Had at Least One of the Efficacy Outcome Measurement|Records participants who had at least one of the efficacy outcome measurement (including death, hospitalization due to VT)|6 Months|||participants|||Number
679969|NCT01576042|Secondary|Number of Participants Completed Month 6 Follow-Up|Records participants who completed Month 6 Follow-Up Visit|6 Months|||participants|||Number
679970|NCT01576042|Primary|Number of Participants Completed Month 3 Follow-Up|Records participants who completed Month 3 Follow-Up Visit|3 months|||participants|||Number
679971|NCT01575912|Primary|Visual Analog Scale Evaluation for the Pre-fixed Pressure Test|"pain tests will be realized during the first week of hospitalization for the persons hospitalized for major depression, and during the period of hospitalization (after stabilization) for the persons presenting schizophrenia.
The controls are tested within one month of the study information. total range : 0 - 10. The intensity of pain increases with the value of VAS. 10 corresponds to an unbearable pain."|one month|analysis per arm group||units on a scale||Standard Deviation|Mean
679972|NCT01575899|Secondary|Eradication Rate of Participants Living in Rural Area.|Subgroup analysis on eradication rate (percentage of participants with a negative result of C13 or CLO test at least four weeks after treatment) according to resident area of participants, especially who are living in rural area.|4 weeks after complete use of drug for treatment|Subgroup analysis (intent-to-treat) on eradication rate of participants who are living in rural area of Taiwan.||percentage of eradicated participants|||Number
679973|NCT01575899|Other Pre-specified|Re-eradication Rate|Re-eradication successful rate (percentage of participants with a negative result of C13 or CLO test at least four weeks after the 2nd treatment) with 7-day levofloxacin, amoxicillin/clavulanate and rabeprazole for patients still with Hp infection previously treated with regimen without levofloxacin and Augmentin.|4 weeks after complete use of drug for treatment|This intent-to treat analysis is without control group, including patients still with Hp infection previously treated with regimen without levofloxacin and Augmentin.||percentage of successful re-eradication|||Number
680094|NCT01573260|Secondary|The Krupp Fatigue Severity Scale|The fatigue severity scale measures impact of fatigue with a 9-item questionnaire, with a 7-point Likert scale for each question It has been validated, and has been used in PD studies. Total score is ranging from 0 (best possible outcome) to 63 (worst possible fatigue).|26 weeks|||score||Standard Deviation|Mean
679974|NCT01575899|Primary|Eradication Rate (Participants Naive to Anti-H. Pylori Treatment)|A negative post-treatment 13C-urea breath test or CLO test result at more than 4 weeks after complete use of drug for treatment.|4 weeks after complete use of drug for treatment|Intent to treat analysis of eradication (negative result of follow up method) measured 4 weeks after complete the treatment, for participants never received anti-H. pylori treatment before.||percentage of eradicated participants|||Number
679975|NCT01575769|Secondary|Absolute C-Reactive Protein Levels||Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, End of follow up (up to 101 weeks)|Safety population. Here, 'n' signifies the number of participants with available data for specified category.||milligrams per Liter||Standard Deviation|Mean
679976|NCT01575769|Secondary|Change From Baseline in CHAQ-DI (Walking) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up|The CHAQ-DI, as a measure of functional ability, consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Walking component was measured on 0-3 scale (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do).|Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)|Safety population. Here, 'n' signifies the number of participants with available data for specified category.||units on a scale||Standard Deviation|Mean
679977|NCT01575769|Secondary|Change From Baseline in CHAQ-DI (Reach) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up|The CHAQ-DI, as a measure of functional ability, consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Reach component was measured on 0-3 scale (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do).|Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)|Safety population. Here, 'n' signifies the number of participants with available data for specified category.||units on a scale||Standard Deviation|Mean
679978|NCT01575769|Secondary|Change From Baseline in CHAQ-DI (Hygiene) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up|The CHAQ-DI, as a measure of functional ability, consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Hygiene component was measured on 0-3 scale (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do).|Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)|Safety population. Here, 'n' signifies the number of participants with available data for specified category.||units on a scale||Standard Deviation|Mean
679979|NCT01575769|Secondary|Change From Baseline in CHAQ-DI (Grip) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up|The CHAQ-DI, as a measure of functional ability, consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Grip component was measured on 0-3 scale (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do).|Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)|Safety population. Here, 'n' signifies the number of participants with available data for specified category.||units on a scale||Standard Deviation|Mean
679980|NCT01575769|Secondary|Change From Baseline in CHAQ-DI (Eating) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up|The CHAQ-DI, as a measure of functional ability, consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Eating component was measured on 0-3 scale (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do).|Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)|Safety population. Here, 'n' signifies the number of participants with available data for specified category.||units on a scale||Standard Deviation|Mean
679981|NCT01575769|Secondary|Change From Baseline in CHAQ-DI (Dressing and Grooming) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up|The CHAQ-DI, as a measure of functional ability, consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Dressing and Grooming component was measured on 0-3 scale (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do).|Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)|Safety population. Here, 'n' signifies the number of participants with available data for specified category.||units on a scale||Standard Deviation|Mean
679982|NCT01575769|Secondary|Change From Baseline in CHAQ-DI (Arising) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up|The CHAQ-DI, as a measure of functional ability, consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Arising component was measured on 0-3 scale (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do).|Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)|Safety population. Here, 'n' signifies the number of participants with available data for specified category.||units on a scale||Standard Deviation|Mean
679983|NCT01575769|Secondary|Change From Baseline in CHAQ-DI (Activitiy) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up|The CHAQ-DI, as a measure of functional ability, consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Activity component was measured on 0-3 scale (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do).|Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)|Safety population. Here, 'n' signifies the number of participants with available data for specified category.||units on a scale||Standard Deviation|Mean
679984|NCT01575769|Secondary|Percentage of Participants With Minimally Important Improvement in the CHAQ-DI Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up|The CHAQ-DI, as a measure of functional ability, consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. There are 4 possible responses to each question (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do). A domain score is the highest score in that domain. To calculate the overall score, the participant must have a domain score in at least 6 of the 8 domains. The CHAQ-DI score is the sum of the domain scores divided by the number of domains that have a non-missing score and ranges from 0 (best) to 3 (worst). A higher score indicates less ability. A minimally important improvement was defined as at least a 0.13 improvement in CHAQ-DI score from baseline.|Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)|Safety population||percentage of participants||95% Confidence Interval|Number
680613|NCT01566630|Primary|Pharmacokinetics of RLX030: Terminal Elimination Half-life (T1/2)- Part 1|Blood concentrations of RLX-030 was assayed to determine this PK parameter.|Baseline, 2, 6, 24,48,72, 76, 80 and 90 hours after initiation of infusion during part 1|No formal analysis was performed as the study was terminated after three patients were enrolled and dosed|||||
679985|NCT01575769|Secondary|Change From Baseline in Childhood Health Assessment – Disability Index (CHAQ-DI) at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up|The CHAQ-DI, as a measure of functional ability, consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. There are 4 possible responses to each question (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do). A domain score is the highest score in that domain. To calculate the overall score, the participant must have a domain score in at least 6 of the 8 domains. The CHAQ-DI score is the sum of the domain scores divided by the number of domains that have a non-missing score and ranges from 0 (best) to 3 (worst). A higher score indicates less ability.|Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)|Safety population. Here, 'n' signifies the number of participants with available data for specified category.||units on a scale||Standard Deviation|Mean
679986|NCT01575769|Secondary|Change From Baseline in ESR at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up||Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)|Safety population. Here, 'n' signifies the number of participants with available data for specified category.||millimeters per hour (mm/hour)||Standard Deviation|Mean
679987|NCT01575769|Secondary|Change From Baseline in PtGA of Overall Well-Being at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up|The participant or parent/guardian, as appropriate, provides a rating of the participant's well-being on a 0 to 100 mm horizontal scale. The extreme left end of the line represents ‘very well’ (ie, symptom-free and no arthritis disease activity) and the extreme right end represents ‘very poor’ (ie, maximum arthritis disease activity). A higher score indicates poorer well-being. A negative change score indicates improvement.|Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)|Safety population. Here, 'n' signifies the number of participants with available data for specified category.||mm||Standard Deviation|Mean
679988|NCT01575769|Secondary|Change From Baseline in PGA of Disease Activity at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up|The physician provides a rating of the participant's arthritis disease activity on a 0 to 100 mm horizontal scale. The extreme left end of the line represents ‘arthritis inactive’ (ie, symptom-free and no arthritis symptoms) and the extreme right end represents ‘arthritis very active’. A higher score indicates more disease activity. A negative change score indicates improvement.|Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)|Safety population. Here, 'n' signifies the number of participants with available data for specified category.||mm||Standard Deviation|Mean
679989|NCT01575769|Secondary|Change From Baseline in Number of Joints With Limitation of Movement at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up|The maximum number of joints with limitation of movement is 67 and these were defined as those with 'limitation of motion'.|Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)|Safety population. Here, 'n' signifies the number of participants with available data for specified category.||Joints||Standard Deviation|Mean
679990|NCT01575769|Secondary|Change From Baseline in Joints With Active Arthritis at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up|Joint with active arthritis was defined as a joint with swelling not due to deformity or joints with limitation of motion and with pain, tenderness or both.|Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)|Safety population. Here, 'n' signifies the number of participants with available data for specified category.||Joints||Standard Deviation|Mean
679991|NCT01575769|Secondary|Percentage of Participants With Clinical Remission at Week 12, 24 and End of Follow up|Clinical remission: inactive disease for minimum of 6 continuous months while on medication (Level 1); off oral corticosteroid medications but still on tocilizumab (Level 2); off both methotrexate and oral corticosteroids but still on tocilizumab (Level 3); or off all anti-arthritis medications-oral corticosteroids, methotrexate, non-steroidal anti-inflammatory drugs but still on tocilizumab (Level 4). Inactive disease: No joints with active arthritis (joints with swelling not due to deformity or joints with limitation of motion and with pain, tenderness or both); No fever, rash, serositis, splenomegaly, hepatomegaly (by physical exam) or generalized lymphadenopathy attributable to sJIA; Normal ESR (<20 mm/hour); PGA of disease activity indicated no disease activity (score ≤10 mm on a 100 mm VAS where 0 [inactive arthritis] and 100 [very active arthritis]). Overall percentage of participants with clinical remission (any level) are reported.|Baseline, Week 12, 24, End of Follow up (up to 101 weeks)|Safety population||percentage of participants||95% Confidence Interval|Number
679992|NCT01575769|Secondary|Percentage of Participants With Inactive Disease at Week 12, 24 and End of Follow up|"Criteria for Inactive Disease:
1) No joints with active arthritis (joints with swelling not due to deformity or joints with limitation of motion and with pain, tenderness or both), 2) No fever, rash, serositis, splenomegaly, hepatomegaly (by physical exam) or generalized lymphadenopathy attributable to systemic juvenile idiopathic arthritis (sJIA), 3) Normal ESR (less than [<] 20 millimeters per hour [mm/hour]), and 4) PGA of disease activity using VAS indicated no disease activity (where no disease activity is considered to be a score less than or equal to [≤]10 mm on a 100 mm VAS where left end of line 0 [inactive arthritis] to right end of line 100 [very active arthritis])."|Baseline, Week 12, 24, End of Follow up (up to 101 weeks)|Safety population||percentage of participants||95% Confidence Interval|Number
679993|NCT01575769|Secondary|Percentage of Participants With JIA ACR 90 Response at Weeks 12, 24 and End of Follow up|JIA ACR90 response was defined as 3 of any 6 core outcome variables improved by at least 90% of the baseline assessments, with no more than 1 of the remaining variables worsened by more than 30%. Six core variables were: PGA of disease activity using VAS from left end of line 0 (inactive arthritis) to right end of line 100 (very active arthritis); PtGA of overall well-being using a VAS from left end of line 0 (very well) to right end of line 100 (very poor); Number of joints with active arthritis (joints with swelling not due to deformity or joints with limitation of motion and with pain, tenderness or both); Number of joints with limitation of movement; Health Assessment Questionnaire: 20 questions in 8 areas (dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities) answered on a scale of 0=without difficulty to 3=unable to do; and ESR.|Baseline, Week 12, 24, End of Follow up (up to 101 weeks)|Safety population||percentage of participants||95% Confidence Interval|Number
680095|NCT01573260|Secondary|Apathy Evaluation Scale (AES)|This is a 14-item patient-rated scale which measures cognitive, emotional, and behavioural symptoms of apathy. All items are rated on a 0 to 3 Likert Scale. The original 18-item scale has been shortened by four items, and wording simplified and it was reported to have excellent psychometric properties in PD (internal consistency reliability = 0.76, test-retest 1 week r = 0.90). Total score is ranging from 0 (best possible outcome) to 42 (worst possible symptoms).|26 weeks|||score||Standard Deviation|Mean
679994|NCT01575769|Secondary|Percentage of Participants With JIA ACR 70 Response at Weeks 12, 24 and End of Follow up|JIA ACR70 response was defined as 3 of any 6 core outcome variables improved by at least 70% of the baseline assessments, with no more than 1 of the remaining variables worsened by more than 30%. Six core variables were: PGA of disease activity using VAS from left end of line 0 (inactive arthritis) to right end of line 100 (very active arthritis); PtGA of overall well-being using a VAS from left end of line 0 (very well) to right end of line 100 (very poor); Number of joints with active arthritis (joints with swelling not due to deformity or joints with limitation of motion and with pain, tenderness or both); Number of joints with limitation of movement; Health Assessment Questionnaire: 20 questions in 8 areas (dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities) answered on a scale of 0=without difficulty to 3=unable to do; and ESR|Baseline, Week 12, 24, End of Follow up (up to 101 weeks)|Safety population||percentage of participants||95% Confidence Interval|Number
679995|NCT01575769|Secondary|Percentage of Participants With JIA ACR 50 Response at Weeks 12, 24 and End of Follow up|JIA ACR50 response was defined as 3 of any 6 core outcome variables improved by at least 50% of the baseline assessments, with no more than 1 of the remaining variables worsened by more than 30%. Six core variables were: PGA of disease activity using VAS from left end of line 0 (inactive arthritis) to right end of line 100 (very active arthritis); PtGA of overall well-being using a VAS from left end of line 0 (very well) to right end of line 100 (very poor); Number of joints with active arthritis (joints with swelling not due to deformity or joints with limitation of motion and with pain, tenderness or both); Number of joints with limitation of movement; Health Assessment Questionnaire: 20 questions in 8 areas (dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities) answered on a scale of 0=without difficulty to 3=unable to do; and ESR.|Baseline, Week 12, 24, End of Follow up (up to 101 weeks)|Safety population||percentage of participants||95% Confidence Interval|Number
679996|NCT01575769|Secondary|Percentage of Participants With JIA ACR 30 Response at Weeks 12, 24 and End of Follow Up|JIA ACR30 response was defined as 3 of any 6 core outcome variables improved by at least 30% of the baseline assessments, with no more than 1 of the remaining variables worsened by more than 30%. Six core variables were: Physician global assessment (PGA) of disease activity using Visual Analog Scale (VAS) from left end of line 0 (inactive arthritis) to right end of line 100 (very active arthritis); Patient/parent global assessment (PtGA) of overall well-being using a VAS from left end of line 0 (very well) to right end of line 100 (very poor); Number of joints with active arthritis (joints with swelling not due to deformity or joints with limitation of motion and with pain, tenderness or both); Number of joints with limitation of movement; Health Assessment Questionnaire: 20 questions in 8 areas (dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities) answered on a scale of 0=without difficulty to 3=unable to do; and Erythrocyte Sedimentation Rate (ESR).|Baseline, Week 12, 24, End of Follow up (up to 101 weeks)|Safety population||percentage of participants||95% Confidence Interval|Number
679997|NCT01575769|Primary|Percentage of Participants With Adverse Events (AEs)|AE: unfavorable and unintended sign, symptom, or disease associated with use of treatment, regardless of treatment relation. Pre-existing conditions that worsened and laboratory or clinical tests that resulted in change in treatment or discontinuation from treatment were reported as AEs. Serious AE: resulted in death, life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was congenital anomaly/birth defect or was medically significant. Severe AE: AE that caused inability to work or perform normal daily activity. AEs of special interest: Serious infections (including opportunistic infections), Myocardial infarction/Acute coronary syndrome, Gastrointestinal perforations and related AE, Malignant neoplasms, Anaphylaxis event, Demyelination-related events, Stroke, Spontaneous or serious bleeding, Serious/medically significant hepatic events. Any AE included serious and non-serious AE.|Baseline to 12 weeks after last actual study medication (up to 101 weeks)|Safety population||percentage of participants|||Number
679998|NCT01575756|Secondary|Clearance|Fibrinogen activity was determined via a validated Clauss assay (fibrinogen activity) and fibrinogen-specific enzyme-linked immunosorbent assay (ie, fibrinogen antigen) using paired antibodies for fibrinogen antigen. All determinations were performed on frozen plasma samples in a central laboratory. The Clauss assay was modified and validated to achieve a limit of quantification of 0.2 g/L. The pharmacokinetic analysis was assessed individually using a non-compartmental model. Plasma levels were measured at Baseline, 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment.|Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment|Pharmacokinetic (PK)-per protocol dataset: All randomised participants who received ≥ 90% of the treatment (T) doses, had any post-T data, did not receive any fibrinogen (F) containing blood products between T and 14 days post-T in both study periods; had sufficient PK data for analysis; had a ≥ 50 mg/dL increase in plasma F within 4 hours post-T.||mL/h/kg||Standard Deviation|Mean
679999|NCT01575756|Secondary|Terminal Half-life (t½)|Fibrinogen activity was determined via a validated Clauss assay (fibrinogen activity) and fibrinogen-specific enzyme-linked immunosorbent assay (ie, fibrinogen antigen) using paired antibodies for fibrinogen antigen. All determinations were performed on frozen plasma samples in a central laboratory. The Clauss assay was modified and validated to achieve a limit of quantification of 0.2 g/L. The pharmacokinetic analysis was assessed individually using a non-compartmental model. Plasma levels were measured at Baseline, 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment.|Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment|Pharmacokinetic (PK)-per protocol dataset: All randomised participants who received ≥ 90% of the treatment (T) doses, had any post-T data, did not receive any fibrinogen (F) containing blood products between T and 14 days post-T in both study periods; had sufficient PK data for analysis; had a ≥ 50 mg/dL increase in plasma F within 4 hours post-T.||h||Standard Deviation|Mean
680000|NCT01575756|Secondary|Incremental in Vivo Recovery|Incremental in vivo recovery was calculated as the maximum increase in plasma fibrinogen (fibrinogen activity assay data) within 4 hours post-treatment as compared with pre-treatment (expressed as an absolute mg/dL concentration in plasma), divided by the exact dose of Octafibrin or Haemocomplettan® P or RiaSTAPTM (expressed as mg/kg dosed).|Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment|Pharmacokinetic (PK)-per protocol dataset: All randomised participants who received ≥ 90% of the treatment (T) doses, had any post-T data, did not receive any fibrinogen (F) containing blood products between T and 14 days post-T in both study periods; had sufficient PK data for analysis; had a ≥ 50 mg/dL increase in plasma F within 4 hours post-T.||mg/dL/(mg/kg)||Standard Deviation|Mean
680001|NCT01575756|Secondary|Fibrinogen Activity Normalized Area Under the Curve Unstandardized|fibrinogen-specific enzyme-linked immunosorbent assay (ie, fibrinogen antigen) using paired antibodies for fibrinogen antigen. All determinations were performed on frozen plasma samples in a central laboratory. The Clauss assay was modified and validated to achieve a limit of quantification of 0.2 g/L. The pharmacokinetic analysis was assessed individually using a non-compartmental model. Plasma levels were measured at Baseline, 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment.|Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment|Pharmacokinetic (PK)-per protocol dataset: All randomised participants who received ≥ 90% of the treatment (T) doses, had any post-T data, did not receive any fibrinogen (F) containing blood products between T and 14 days post-T in both study periods; had sufficient PK data for analysis; had a ≥ 50 mg/dL increase in plasma F within 4 hours post-T.||h•kg•g/L/mg||Standard Deviation|Mean
680002|NCT01575756|Primary|Comparison of Maximum Clot Firmness Between Octafibrin and Haemocomplettan P/RiaSTAP at 1 hr Post Infusion|Thromboelastography (TEG) using rotational thromboelastometry (ROTEM®) was used to measure maximum clot firmness. Rotational thromboelastometry is a method for the continuous measurement of clot formation. Maximum clot firmness is a functional parameter that depends on the activation of coagulation, the platelet and fibrinogen content of the blood sample, and the polymerisation and cross-linking of the fibrin network. In order to obtain comparable results from all study centres, maximum clot firmness data were assessed from frozen citrated plasma samples in a central laboratory. As these samples did not contain platelets that would be found in the whole blood assay, only the fibrinogen content defined the maximum clot firmness.|Baseline to 1 hour post-treatment|Full analysis set: All randomised participants who received at least 1 infusion of study medication (Octafibrin and/or any part of an infusion of Haemocomplettan® P or RiaSTAPTM) and for whom any post-treatment data were available.||mm||95% Confidence Interval|Mean
680003|NCT01575756|Primary|Fibrinogen Activity Normalized Area Under the Curve Standardized|Fibrinogen activity was determined via a validated Clauss assay (fibrinogen activity) and fibrinogen-specific enzyme-linked immunosorbent assay (ie, fibrinogen antigen) using paired antibodies for fibrinogen antigen. All determinations were performed on frozen plasma samples in a central laboratory. The Clauss assay was modified and validated to achieve a limit of quantification of 0.2 g/L. The pharmacokinetic analysis was assessed individually using a non-compartmental model. Plasma levels were measured at Baseline, 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment. The normalized area under the curve was standardized to a dose of 70 mg/kg.|Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment|Pharmacokinetic (PK)-per protocol dataset: All randomised participants who received ≥ 90% of the treatment (T) doses, had any post-T data, did not receive any fibrinogen (F) containing blood products between T and 14 days post-T in both study periods; had sufficient PK data for analysis; had a ≥ 50 mg/dL increase in plasma F within 4 hours post-T.||g•h/L||Standard Deviation|Mean
680004|NCT01575561|Secondary|Change From Baseline to Week 12 (LOCF) in the SDS Total Score|The SDS is a composite of three self-rated items designed to measure the extent to which three major sectors in the patient’s life are impaired by depressive symptoms. The SDS total score is calculated as the sum of the 3 items. The SDS total score ranges from 0 to 30. Higher scores are associated with greater severity of global functional impairments. If a subject has not worked/studied at all during the past week for reasons unrelated to the disorder, the SDS total score will be set to missing.|baseline, week 12 (LOCF)|only 297 of the 377 subjects had the SDS total score at week 12 (LOCF)||units on a scale||Standard Deviation|Mean
680005|NCT01575561|Secondary|Change From Baseline to Week 12 (LOCF) in the CGI-BP-S Depression Scale|The CGI-BP-S depression score is a single value, clinician-rated assessment of depression illness severity and range from 1=normal, not at all ill to 7=Among the most extremely ill patients. A higher score is associated with greater illness severity.|baseline, week 12 (LOCF)|only 375 of the 377 subjects had the CGI-BP-S depression assessment at Week 12 (LOCF)||units on a scale||Standard Deviation|Mean
680006|NCT01575561|Secondary|Change From Baseline to Week 12 (LOCF) in the CGI-BP-S Mania Score|The CGI-BP-S mania score is a single value, clinician-rated assessment of mania illness severity and ranges from 1=Normal, not at all ill to 7= Among the most extremely ill patients. A higher score is associated with greater illness severity|baseline, week 12 (LOCF)|Only 375 of the 377 subjects had the CGI-BP-S mania assessment at week 12 (LOCF)||units on a scale||Standard Deviation|Mean
680007|NCT01575561|Secondary|Change From Baseline to Week 12 (LOCF) in the CGI-BP-S Overall Score- Severity of Illness as Assessed by the Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S)|Severity of illness as assessed by the Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) -The CGI-BP-S overall score is a single value, clinician-rated assessment of overall bipolar illness severity and ranges from 1= ‘Normal, not at all ill’ to 7= ‘Among the most extremely ill patients’. A higher score is associated with greater illness severity.|baseline, week 12 (LOCF)|only 375 of the 377 subjects had the CGI-BP-S overall assessment at week 12 (LOCF)||units on a scale||Standard Deviation|Mean
680008|NCT01575561|Secondary|Change From Baseline to Week 12 (LOCF) in the MADRS Total Score- Depression as Assessed by Montgomery-Asberg Depression Rating Scale (MADRS)|Depression as assessed by Montgomery-Asberg Depression Rating Scale (MADRS) -The MADRS consists of 10 items, each rated on a Likert scale, from 0=”Normal” to 6=”Most Severe”. The MADRS total score is calculated as the sum of the 10 items. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity of depression.|baseline ,Week 12 (LOCF)|Only 375 of the 377 subjects had the MADRS assessment at week 12 (LOCF)||units on a scale||Standard Deviation|Mean
680009|NCT01575561|Secondary|Change From Baseline to Week 12 (LOCF) in the YMRS Total Score -Mania as Assessed by Young Mania Rating Scale (YMRS)|Movement disorders as assessed by Young Mania Rating Scale (YMRS) The YMRS is an 11-item instrument used to assess the severity of mania in subjects with a diagnosis of bipolar disorder. Ratings are based on patient self-reporting, combined with clinician observation (accorded greater score). The YMRS total score is calculated as the sum of the 11 items. The YMRS total score ranges from 0 to 60. Higher scores are associated with greater severity of mania.|Baseline, 12 weeks (LOCF)|only 375 of the 377 subjects had the YMRD assessment at week 12 (LOCF)||units on a scale||Standard Deviation|Mean
680010|NCT01575561|Secondary|Change From Baseline to Week 12 (LOCF) in the Positive and Negative Syndrome Scale Positive Subscale (PANSS P) Score|The PANSS-P is a subset of items in the PANSS, an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure contains seven questions to assess delusions, conceptual disorganization, hallucinations behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS-P subscale score is the sum of the 7 items and ranges from 7 through 49. A higher score is associated with greater illness severity.|baseline, 12 weeks (LOCF)|only 359 of the 377 subjects had the PANSS-P assessment at week 12 (LOCF)||units on a scale||Standard Deviation|Mean
680011|NCT01575561|Secondary|Change From Baseline to Week 12 (LOCF) in the Quick Inventory of Depressive Symptomatology - Self Report (QIDS SR16) Total Score|The QIDS-SR16 is a 16-item self-report measure of depressive symptomatology which uses a computerized assessment interface for administration. The scoring system for the QIDS-SR16 converts responses to 16 separate items into nine DSM-IV symptom criterion domains. The nine domains comprise: depressed mood (Item 5); concentration/decision making (Item 10); self outlook (Item 11); suicidal ideation (Item 12); decreased interest (Item 13); decreased energy (Item 14); sleep disturbance (initial, middle, and late insomnia or hypersomnia) (highest score of Items 1 to 4); appetite/weight disturbance (highest score of Items 6 to 9); and psychomotor disturbance (highest score of Items 15 and 16). The QIDS-SR16 total score is calculated as the sum of the 9 domain scores. The QIDS-SR16 total score ranges from 0 to 27 with a high score indicating more severe symptoms.|baseline, 12 weeks (LOCF)|only 351 of the 377 subjects had the QIDS-SR16 assessment at week 12 (LOCF)||units on a scale||Standard Deviation|Mean
680012|NCT01575561|Primary|Treatment-emergent Adverse Events and Treatment-emergent Adverse Events Leading to Discontinuation and Serious Adverse Events|Number of subjects with treatment emergent AEs, SAEs, and TEAEs leading to discontinuation|12 weeks|||participants|||Number
680013|NCT01575522|Secondary|To Evaluate the Incidence of c-Met Positive Circulating Tumor Cells.||Baseline|||participants|||Number
680014|NCT01575522|Secondary|To Evaluate Phospho c-Met Expression in Archival Tumor Tissue.|MET amplification was defined as a MET/CEP7 ratio ≥ 2. Samples having a MET/CEP7 ratio from 1.5 and up to 2 were defined as having relative MET gain. Samples with a MET/CEP7 ratio of 1 but with more than two copies of each probe were defined as having polysomy of chromosome 7.|Baseline|||participants|||Number
680015|NCT01575522|Secondary|To Evaluate c-Met Expression in Archival Tumor Tissue.|Assessment of ploidy status was done by visual screening of all tumor area; cells with maximum number of signals were recorded. MET amplification was defined as a MET/CEP7 ratio ≥ 2. Samples having a MET/CEP7 ratio from 1.5 and up to 2 were defined as having relative MET gain. Samples with a MET/CEP7 ratio of 1 but with more than two copies of each probe were defined as having polysomy of chromosome 7.|Baseline|||participants|||Number
680016|NCT01575522|Secondary|Overall Response Using RECIST v1.1|The 95% confidence intervals should be provided. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by Conventional CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >/=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 1 year|||percentage of participants||95% Confidence Interval|Number
680017|NCT01575522|Primary|PFS Status|Analyzed using the Kaplan-Meier method. 95% confidence intervals (CI) will be determined. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Time from start of treatment to time of progression or death, assessed up to 6 months|||months||95% Confidence Interval|Median
680018|NCT01575197|Secondary|SAE Assessment|Serious adverse events (SAEs) occurring at anytime during the study will be measured as observed by study staff and/or reported by parent at any time. SAEs will be subcategorized according to treatment group as those deemed related to vaccination or not by an independent study monitor.|Throughout study period; Group 1: from enrollment through approximately 8 weeks of study participation, Groups 2 & 3: from enrollment through approximately 12 weeks of study participation||||||
680019|NCT01575197|Secondary|Vaccine-type Rotavirus Shedding in Stool|Vaccine-type rotavirus shedding in the stool at 4 (±1 day) and 7 days (±1 day) following each Rotarix vaccination will be identified using EIA for rotavirus antigens and compared to baseline levels obtained just prior to each study vaccination. If shedding in stool is detected at either time point (per manufacturer’s specifications) following each Rotarix vaccination, this will be considered evidence of vaccine take.|Days 4 and 7 post each study vaccination||||||
680020|NCT01575197|Secondary|Baseline Immunoglobulin G (IgG) Levels: Impact on IgA Seroconversion Post-vaccination|The number and percentage of participants demonstrating IgA seroconversion post-vaccination as defined above in infants seronegative for anti-rotavirus IgA pre- vaccination using the EIA assay) by EIA pre- and post-vaccination will be compared between participants in each group who had low as compared to high rotavirus immunoglobulin G (IgG) antibody levels pre-vaccination (i.e., at 6 weeks in Groups 1 and 3 and at 10 weeks in Group 2) as measured by Enzyme linked immunosorbent assay (ELISA). Low and high IgG categories will be determined based on the IgG antibody level distribution.|Baseline, 4-weeks post-vaccination (All Groups) and 8 weeks post-vaccination (6 & 10 week Group)||||||
680021|NCT01575197|Secondary|IgA GMTs: 6 & 10 Week vs. 10 & 14 Week Vaccination Schedule|IgA GMTs measured by EIA will be compared post-vaccination between participants receiving Rotarix at 6 and 10 weeks of age and those receiving Rotarix at 10 and 14 weeks of age. For participants in Group 1, where post-vaccination response was measured at both 14 and 18 weeks of age, the highest response between these two visits was used as the final response for comparison.|4-weeks post-vaccination (All Groups) and 8 weeks post-vaccination (6 & 10 week Group)|Per-protocol analysis population--participants who (1) meet inclusion/exclusion criteria; (2) seronegative pre- vaccination; (3) concomitant administration of HRV and OPV according to Group schedule, (4) study visits in window periods (vaccination visits 4 weeks + 2 weeks), and (5) valid serology results.||titers||95% Confidence Interval|Geometric Mean
680297|NCT01571362|Secondary|Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Average Pain|BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; higher scores indicate greater pain.|Weeks 2, 4, 8, and 12|ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for average pain at the specified timepoint.||Units on a Scale||Standard Error|Least Squares Mean
680022|NCT01575197|Secondary|IgA Geometric Mean Titers (GMTs): 6 & 10 Week vs. 6, 10, & 14 Week Vaccination Schedules|IgA GMTs measured by EIA will be compared post-vaccination between participants receiving Rotarix at 6 and 10 weeks of age and those receiving Rotarix at 6, 10, and 14 weeks of age. For participants in Group 1, where post-vaccination response was measured at both 14 and 18 weeks of age, the highest response between these two visits was used as the final response for comparison.|4-weeks post-vaccination (All Groups) and 8 weeks post-vaccination (6 & 10 week Group)|Per-protocol analysis population--participants who (1) meet inclusion/exclusion criteria; (2) seronegative pre- vaccination; (3) concomitant administration of HRV and OPV according to Group schedule, (4) study visits in window periods (vaccination visits 4 weeks + 2 weeks), and (5) valid serology results.||titers||95% Confidence Interval|Geometric Mean
680023|NCT01575197|Secondary|IgA Seroconversion: 6 & 10 Week vs. 10 & 14 Week Vaccination Schedules|Anti-rotavirus IgA seroconversion will be defined as the detection of anti-rotavirus IgA antibodies at a concentration ≥20 U/mL post-vaccination in infants seronegative for anti-rotavirus IgA pre- vaccination as measured by EIA.|4-weeks post-vaccination (All Groups) and 8 weeks post-vaccination (6 & 10 week Group)|Per-protocol analysis population--participants who (1) meet inclusion/exclusion criteria; (2) seronegative pre- vaccination; (3) concomitant administration of HRV and OPV according to Group schedule, (4) study visits in window periods (vaccination visits 4 weeks + 2 weeks), and (5) valid serology results.||percentage of participants||95% Confidence Interval|Number
680024|NCT01575197|Primary|Immunoglobulin A (IgA) Seroconversion: 6 & 10 Week vs. 6, 10, & 14 Week Vaccination Schedules|Anti-rotavirus IgA seroconversion will be defined as the detection of anti-rotavirus IgA antibodies at a concentration ≥20 U/mL post-vaccination in infants seronegative for anti-rotavirus IgA pre-vaccination as measured by Enzyme Immunoassay (EIA).|4-weeks post-vaccination (All Groups) and 8 weeks post-vaccination (6 & 10 week Group)|Per-protocol analysis population--participants who (1) meet inclusion/exclusion criteria; (2) seronegative pre- vaccination; (3) concomitant administration of HRV and oral polio vaccine (OPV) according to Group schedule, (4) study visits in window periods (vaccination visits 4 weeks + 2 weeks), and (5) valid serology results.||percentage of participants||95% Confidence Interval|Number
680025|NCT01575080|Secondary|Number of Subject Responses That 'Agree' or 'Strongly Agree' With Questionnaire Statements|Subjects will complete short questionnaires to provide feedback on the labeling materials and system ease of use. Subjects may respond 'Strongly Agree' 'Agree' 'Neutral' 'Disagree' 'Strongly Disagree'.|1 hour|||participants|||Number
680026|NCT01575080|Secondary|Number of Self-Test Alternative Site (Forearm) Blood Glucose Results Within +/- 15mg/dL (<100mg/dL) or Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method|Untrained subjects with diabetes self-test Alternative Site (AST) Forearm blood using the Blood Glucose Monitoring System (BGMS). BGMS AST forearm results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma BG results are used to calculate the number of AST forearm BGMS results within +/- 15mg/dL (<100mg/dL YSI capillary plasma) or +/- 15% (>=100mg/dL YSI capillary plasma).|1 hour|102 untrained subjects tested one test strip lot using the Contour TS BG Monitoring System. One subject was unable to obtain sufficient sample volume to test. Another subject's meter displayed||Number of BG Test Results|Participants||Number
680027|NCT01575080|Secondary|Number of Self-Test Alternative Site (Palm) Blood Glucose Results Within +/- 15mg/dL (<100mg/dL) or Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method|Untrained subjects with diabetes self-test Alternative Site (AST) Palm blood using the Blood Glucose Monitoring System (BGMS). BGMS AST palm results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma BG results are used to calculate the number of AST palm BGMS results within +/- 15mg/dL (<100mg/dL YSI capillary plasma) or +/- 15% (>=100mg/dL YSI capillary plasma).|1 hour|102 untrained subjects tested one test strip lot on the Contour TS Blood Glucose Monitoring System||Number of BG Test Results|Participants||Number
680028|NCT01575080|Primary|Number of Self-Test Fingerstick Blood Glucose Results Within +/- 15mg/dL (<100mg/dL) or Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method|Untrained subjects with diabetes self-test fingerstick blood using the Blood Glucose Monitoring System (BGMS). BGMS results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results are used to calculate the number of BGMS results within +/- 15mg/dL (<100mg/dL YSI capillary plasma) or +/- 15% (>=100mg/dL YSI capillary plasma).|1 hour|102 untrained subjects tested one test strip lot on the Contour TS Blood Glucose Monitoring System.||Number of BG Test Results|Participants||Number
680029|NCT01575054|Secondary|Change From Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Score of Optional Muscles Using a 6-Point Scale|The MAS-B is a 6-point scale used to evaluate spasticity based on grading the resistance encountered in the optional muscles by passively moving the muscles through their range of motion. Optional muscles treated include: Rectus Femoris, Flexor Digitorum Longus, Flexor Hallucis Longus, and Extensor Hallucis. The scores range from 0 (no increase in muscle tone) to 4 (affected part(s) rigid in flexion or extension). Scores are converted to a 0 to 5 grade. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.|Baseline, Week 6|Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received||Scores on a Scale||Standard Deviation|Least Squares Mean
680030|NCT01575054|Secondary|Change From Baseline in Average Pain Score While Walking on the 11-Point Pain Scale|The patient is asked to select a number that best describes his/her pain while walking on an 11-point scale from 0 = “no pain” to 10 = “pain as bad as can be imagined”. Patients are instructed to recall their average pain in the study limb during the 48-hour period prior to the visit. Patients with a baseline pain score >0 are included in the analyses.|Baseline, Week 6|Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received||Scores on a Scale||Standard Deviation|Least Squares Mean
680031|NCT01575054|Secondary|Goal Attainment Scores on the 6-Point Physician-Assessed Goal Attainment Scale (GAS)|The physician-assessed GAS is an individualized, goal-oriented 6-point scale used to track functional improvement toward active and passive goals. GAS scoring ranged from −3 to 2 (−3 = worse than start; 0 = expected goal/attained the defined therapeutic goal; 2 = much more than expected/improvements clearly exceeded the defined therapeutic goal). Active and Passive Goal scores are presented.|Week 8|Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received||Scores on a Scale||Standard Deviation|Least Squares Mean
680032|NCT01575054|Secondary|Clinical Global Impression (CGI) of Overall Change by Physician Using a 9-Point Scale|The CGI is a 9-point scale evaluating change from baseline status by the Physician. Scores range from +4 (very marked improvement) to -4 (very marked worsening). The average of the weeks 4 and 6 CGI by Physician score is used as a secondary end point. Higher scores indicate a greater improvement from baseline.|Baseline, 6 weeks|Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received||Scores on a Scale||Standard Deviation|Least Squares Mean
680033|NCT01575054|Primary|Change From Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Score of Ankle Plantar Flexors Using a 6-Point Scale|The MAS-B is a 6-point scale used to evaluate spasticity based on grading the resistance encountered in the ankle flexors by passively moving the ankle plantar flexor muscles through their range of motion. The score ranges from 0 (no increase in muscle tone) to 4 (affected part(s) rigid in flexion or extension). Scores are converted to a 0 to 5 grade. The average of the weeks 4 and 6 MAS-B ankle change from baseline is the primary end point. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.|Baseline, 6 Weeks|Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received||Scores on a Scale||Standard Deviation|Least Squares Mean
680034|NCT01575028|Primary|Post-operative Pain Relief|Prospectively compare post-operative pain relief in pediatric patients undergoing laparoscopic appendectomy who have received either a transversus abdominis plane (TAP) block or local anesthetic infiltration by the surgeon for analgesia.|12 hours post-operatively|Due to changes in surgical technique & protocols by the general surgeons, we were only able to recruit 3 study subjects and the study was terminated. No analysis was performed.|||||
680035|NCT01574703|Secondary|Incidence of MACE+ Assessed Until End of Study NCT01574703.|This is an adjudicated endpoint. MACE+ is defined as any MACE or a new onset or worsening PVD requiring intervention, a need for coronary revascularization, or hospitalization for unstable angina.|Baseline until end of study (end of study is defined as last visit in study NCT01574703 [up to Week 52], or in study NCT01456936 [up to 24 Weeks] for those participants not enrolled into study NCT01574703).|The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.||percentage of participants|||Number
680036|NCT01574703|Secondary|Incidence of MACE Assessed Until End of Study NCT01574703.|This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated until end of study.|Baseline until end of study (end of study is defined as last visit in study NCT01574703 [up to Week 52], or in study NCT01456936 [up to 24 Weeks] for those participants not enrolled into study NCT01574703).|The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.||percentage of participants|||Number
680037|NCT01574703|Secondary|Incidence of MACE+ Assessed up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936.|This is an adjudicated endpoint. MACE + is defined as any MACE or a new onset or worsening PVD requiring intervention, a need for coronary revascularization, or hospitalization for unstable angina.|Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks) plus 30 days follow-up.|The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.||percentage of participants|||Number
680038|NCT01574703|Secondary|Incidence of MACE Assessed up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936.|This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated during the treatment phase (up to date of last dose of study drug) plus 30 days follow-up.|Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks) plus 30 days follow-up.|The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.||percentage of participants|||Number
680039|NCT01574703|Secondary|Incidence of MACE + Assessed During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936.|This is an adjudicated endpoint. MACE + is defined as any MACE or a new onset or worsening peripheral vascular disease (PVD) requiring intervention, a need for coronary revascularization, or hospitalization for unstable angina.|Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks).|The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.||percentage of participants|||Number
680040|NCT01574703|Secondary|Incidence of MACE Assessed During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936.|This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated during the treatment phase (up to date of last dose of study drug).|Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks).|The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.||percentage of participants|||Number
680041|NCT01574703|Secondary|Time to MACE Until the End of Study NCT01574703.|This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated until end of study. The measure type mentioned in the outcome data table is Hazard Ratio.|Baseline until end of study (end of study is defined as last visit in study NCT01574703 [up to Week 52], or in study NCT01456936 [up to 24 Weeks] for those participants not enrolled into study NCT01574703).|The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.||Unitless||95% Confidence Interval|Number
680042|NCT01574703|Secondary|Time to MACE up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936.|This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated during the treatment phase (up to date of last dose of study drug) plus 30 days follow-up. The measure type mentioned in the outcome data table is Hazard Ratio.|Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks) plus 30 days.|The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.||Unitless||95% Confidence Interval|Number
681089|NCT01562314|Secondary|Clinical Efficacy Blood Sample Measurements - Tumour Necrosis Factor (TNF)|Change in serum cytokine TNF-alpha from Baseline to Final Visit|Baseline to end of treatment (10 week treatment period)|ITT analysis set||pg/mL||Standard Deviation|Mean
680043|NCT01574703|Primary|Time to Occurrence of Major Adverse Cardiovascular Event (MACE) During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936.|This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated during the treatment phase (up to date of last dose of study drug). The measure type mentioned in the outcome data table is Hazard Ratio relative to Placebo.|Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks).|The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.||Unitless||95% Confidence Interval|Number
680044|NCT01574651|Secondary|"Symptoms Score Reported by the Patients Using Part I Symptoms of SGRO-C"|Part I of the SGRQ-C covers “symptoms” and is concerned with respiratory symptoms, their frequency and severity. Each questionnaire response has a unique empirically derived “weight”. A score was calculated from these weights. The lowest possible value is zero and the highest 100. A higher value corresponds to greater impairment of health status.|Baseline, Week 26|Full analysis set (FAS): all randomized patients who received at least one dose of randomized study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned to. The FAS was used for all efficacy variables unless otherwise stated||Score on a scale||Standard Deviation|Mean
680045|NCT01574651|Secondary|FEV1 30 Min After the Morning Dose at Baseline and Week 26|FEV1 30min is the forced expiratory volume in one second measured 30 min after the morning dose.|Baseline, Week 26|Full analysis set (FAS): all randomized patients who received at least one dose of randomized study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned to. The FAS was used for all efficacy variables unless otherwise stated||Liters||Standard Deviation|Mean
680046|NCT01574651|Secondary|Trough FEV1 at Baseline and Week 26|Trough FEV1 is the mean value of FEV1 (forced expiratory volume in one second) measured at 23:15h and 23:45h after the morning doses. The baseline value was measured at day 1 prior to the first dose.|Baseline, Week 26|Full analysis set (FAS): all randomized patients who received at least one dose of randomized study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned to. The FAS was used for all efficacy variables unless otherwise stated||Liters||Standard Deviation|Mean
680047|NCT01574651|Secondary|Time- Event Analysis, Number of Participants With at Least One COPD Exacerbation (Moderate or Severe) During the Treatment Period|The number of participants with at least one moderate or severe COPD exacerbation. COPD exacerbations are considered to be moderate if treatment with systemic corticosteroids and/or antibiotics was required. COPD exacerbations are considered to be severe if hospitalizations were required.|Week 26|Full analysis set (FAS): all randomized patients who received at least one dose of randomized study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned to. The FAS was used for all efficacy variables unless otherwise stated||Participants|||Number
680048|NCT01574651|Secondary|Percent of Participants With at Least One Exacerbation Requiring Hospitalization|The percent of patients with at least one severe exacerbation within the 26 weeks that required hospitalization. COPD exacerbations were considered to be severe if hospitalization were required.|Week 26|Full analysis set (FAS): all randomized patients who received at least one dose of randomized study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned to. The FAS was used for all efficacy variables unless otherwise stated||Percent of participants|||Number
680049|NCT01574651|Secondary|Percent of Participants With at Least One Exacerbation Requiring Systemic Corticosteroids and/or Antibiotics Over 26 Weeks|The percent of participants with at least one moderate exacerbation within the 26 weeks that required systemic corticosteroids and/or antibiotics during the treatment|Week 26|Full analysis set (FAS): all randomized patients who received at least one dose of randomized study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned to. The FAS was used for all efficacy variables unless otherwise stated||Percent of participants|||Number
680050|NCT01574651|Secondary|Transition Dyspnea Index (TDI) Focal Score After 26 Weeks of Treatment.|Baseline Dyspnea Index (BDI)/Transition Dyspnea Index (TDI) focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort and captures changes from baseline. BDI was measured at day 1 prior to the first dose with domain scores ranging from 0=very severe to 4=no impairment and a total score ranging from 0 to 12(best). TDI captures changes from baseline. Each domain is scored from -3=major deterioration to 3=major improvement to give an overall TDI focal score of -9 to 9. Higher numbers indicate a better score. missing values were replaced by the latest observed value (LOCF)|Week 26|Full analysis set (FAS): all randomized patients who received at least one dose of randomized study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned to. The FAS was used for all efficacy variables unless otherwise stated||Units on a scale||Standard Deviation|Mean
680051|NCT01574651|Secondary|St. George’s Respiratory Questionnaire (SGRQ-C) Total Score After 26 Weeks of Treatment (Superiority Analysis).|SGRQ is a health related quality of life questionnaire consisting of 40 items in three areas: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). The total score is 0 to 100 with a higher score indicating poorer health status. For patients who completed the study but with missing SGRQ-C during treatment, the missing SGRQ-C were replaced by the last observation carried forward (LOCF). Symptom scores were expected to improve over treatment, therefore the replacement of missing values with earlier measurements did not result in overoptimistic imputation and this procedure could be regarded as conservative. Superiority of QVA 110/50 μg to tiotropium 18 μg q.d. plus formoterol 12 μg b.i.d. in terms of health related quality of life as assessed by St George’s Respiratory Questionnaire (SGRQ-C) after 26 weeks of treatment|Baseline, week 26|Full analysis set (FAS): all randomized patients who received at least one dose of randomized study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned to. The FAS was used for all efficacy variables unless otherwise stated||Score on a scale||Standard Deviation|Mean
680096|NCT01573260|Secondary|The Beck Depression Inventory (BDI)|"The BDI is a self-administered scale of 21 items (scored 0-3) which assesses depression symptoms. The Beck Inventory is one of the most commonly-used scales for depression in PD, and a recent consensus panel of the Movement Disorders Society concluded it was a scale of first choice for assessing depression in PD. Total score for the BDI is the sum of 21 items, ranging from 0 (best possible outcome) to 63 (worst possible symptoms)"|26 weeks|||score||Standard Deviation|Mean
680052|NCT01574651|Primary|St. George’s Respiratory Questionnaire (SGRQ-C) Total Score After 26 Weeks of Treatment (Non-inferiority Analysis).|SGRQ is a health related quality of life questionnaire consisting of 40 items in three areas: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). The total score is 0 to 100 with a higher score indicating poorer health status. For patients who completed the study but with missing SGRQ-C during treatment, the missing SGRQ-C were replaced by the last observation carried forward (LOCF). Symptom scores were expected to improve over treatment, therefore the replacement of missing values with earlier measurements did not result in overoptimistic imputation and this procedure could be regarded as conservative.|Baseline, week 26|Full analysis set (FAS): all randomized patients who received at least one dose of randomized study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned to. The FAS was used for all efficacy variables unless otherwise stated.||Score on a scale||Standard Deviation|Mean
680053|NCT01574612|Primary|Reporting of Adverse Events|treatment period is for 5 days and follow up visits at 7days and 21 days after first dose|day 1 to day 21|||participants|||Number
680054|NCT01574326|Secondary|Change From Baseline (Week 0) to Week 28/Early Termination in Serum Phosphorus|Full analysis set for dose titration period (FAS-DTP) participants were analyzed according to their randomized treatment. The change in serum phosphorus (mg/dL) from baseline to Week 28/Early Termination was calculated.|Baseline, Week 28/Early Termination|FAS-DTP population included all treated participants with a baseline phosphorus value and at least 1 post-baseline phosphorus assessment after Week 2. Five participants (3 in sevelamer carbonate group and 2 in the placebo group) were excluded from the FAS-DTP due to no baseline phosphorus value or no phosphorus assessment after Week 2.||mg/dL||Standard Deviation|Mean
680055|NCT01574326|Primary|Treatment – Emergent Adverse Events (AEs)|A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect. AEs from the time of signing the informed consent through the end of the study for all participants. SAEs occurring during the 15 days following study completion or early termination were also to be collected.|Up to 32 weeks (up to 4 weeks washout period, 2 weeks FDP and 26 weeks DTP)|Analysis was performed on safety set, which included all enrolled participants who received at least 1 dose of study drug. Participants were analyzed according to actual received treatment.||participants|||Number
680056|NCT01574326|Primary|Change From Baseline (Week 0) to Week 2 in Serum Phosphorus|Full analysis set for fixed dose period (FAS-FDP) participants were analyzed according to their randomized treatment. The change in serum phosphorus (mg/dL) from baseline to week 2 was calculated.|Baseline, Week 2|FAS-FDP population included all treated participants with a baseline phosphorus value and at least 1 post-baseline assessment after the first dose of study drug and on or before Week 2. Three participants (1 in sevelamer carbonate group and 2 in placebo group) were excluded from FAS-FDP due to no baseline phosphorus value at week 2.||mg/dL||Standard Deviation|Mean
680057|NCT01574248|Secondary|Systolic Blood Pressure|Average of blood pressure measurements from zero to forty-eight hours provided.|T0 to T48 hours|||mmHg||Standard Deviation|Mean
680058|NCT01574248|Secondary|Number of Participants Given Epinephrine||T0 to T48 hours|||Participants|||Count of Participants
680059|NCT01574248|Secondary|Number of Participants Given Histamine Receptor Type 1 (H1) and Type 2 (H2) Blockers||T0 to T48 hours|||Participants|||Count of Participants
680060|NCT01574248|Secondary|Number of Participants Given Steroids||T0 to T48 hours|||Participants|||Count of Participants
680061|NCT01574248|Secondary|Number of Participants With Requirement for Intubation||T0 to T48 hours|||Participants|||Count of Participants
680062|NCT01574248|Secondary|Number of Participants With Admission to Intensive Care Unit||T0 to T48 hours|||Participants|||Count of Participants
680063|NCT01574248|Primary|Time to Resolution of Angioedema|Time interval between initiation of treatment and when there is no symptom, by visual analog scale <1 cm. Data provided are for worst symptom.|48 hours|||hours||95% Confidence Interval|Median
680064|NCT01574183|Secondary|Marijuana Craving and Withdrawal|The Marijuana Craving Questionnaire (MCQ) is intended to measure marijuana craving in adults. It measures symptoms on four subscales: expectancy, purposefulness, emotionality, and compulsivity. The scale rates individual items from 1 (least craving) – 7 (most craving) with a composite scoring range of 12-84 and possible subscale scoring range of 3-21. It was administered weekly to all participants. Reported here is the mean MCQ purposefulness subscale score across 8 weeks.|8 weeks|||units on a scale||95% Confidence Interval|Mean
680065|NCT01574183|Secondary|Weekly Cannabis Use Sessions|Self-report of weekly cannabis use sessions was measured using the Time Line Followback, a calendar-based instrument designed to assess substance consumption.|8 weeks|||weekly cannabis sessions||95% Confidence Interval|Mean
680066|NCT01574183|Primary|Percent Marijuana-negative Urine Drug Screens (UDS)|Participants submitted a urine sample weekly. Percentage of marijuana negative urine samples were calculated per group.|8 weeks|||percentage of UDS|Participants||Number
680067|NCT01574105|Secondary|Transfusion Events|Transfusion events to recorded will be the number of patients receiving units of red blood cells, units of platelets, units of plasma and units of cryoprecipitate.|Data collection begins with patient arrival in the operating room and ends with discharge from the ICU (normally less than 24hrs)|||Participants|||Number
680068|NCT01574105|Primary|Chest Tube Losses|Chest tube losses will be measured in millilitres upon arrival in the Intensive Care unit (ICU) after six hours in the ICU and total chest tube losses during the ICU stay. Chest tube losses are the amount of blood collected in a graduated chest tube collection reservoir from chest tubes placed in the patient's chest wound at the end of surgery.|Chest tube losses are recorded from departure from operating room to chest tube removal in the ICU (normally less than 24 hrs)|||millilters||Standard Deviation|Mean
680161|NCT01572740|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 36|Estimated mean change from baseline in FPG after 36 Weeks of treatment.|Week 0, Week 36|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial products. Missing data were imputed using last observation carried forward (LOCF). 1 subject in the placebo group did not contribute to the statistical analysis at Week 36 as subject was withdrawn from the trial before sampling for any efficacy data.||mmol/L||Standard Error|Mean
680069|NCT01574079|Secondary|Stroke Rehabilitation Assessment of Movement|The Stroke Rehabilitation Assessment of Movement (STREAM)is designed to measure mobility and motor ability after stroke. There are three subscales with 10 items each assessing the upper extremity, lower extremity, and basic mobility. Only the lower extremity and basic mobility items were used in this study. The lower extremity scores ranged from 0 - 18 with higher scores indicating a higher level of motor control. The basic mobility scores ranged from 0 - 30 with high numbers indicating a higher level of functional mobility.|measured at admission and discharge with estimated length of stay 14 days|||outcome score||Standard Deviation|Mean
680070|NCT01574079|Secondary|Timed Up and Go|The Timed Up and Go (TUG) is used to assess balance and gait, and to estimate fall risks in patients with deficits. The participant rises from a seated position in a chair, walks 3 meters, turns around, returns to the chair, and sits down. The test is measured in seconds, with a lower number indicating a higher level of independence and the least risk for falls.|Measured at admission and discharge with estimated length of stay 14 days|||seconds||Standard Deviation|Mean
680071|NCT01574079|Primary|Functional Independence Measure - Locomotor Score|The Functional Independence Measure (FIM)assesses level of disability and measures progress toward independence with rehabilitational intervention. The tool consists of 18 items. Only the the locomotor score was used to assess gait ability in this study. The locomotor score ranges from 1 - 7 with a higher score indicating a higher level of functional independence.|measured at admission and discharge from rehab estimated length of stay 14 days|Thirty-three participants enrolled in the study with 3 dropping out before completion. Two of these were due to medical issues, and one was discharged unexpectedly||outcome score||Standard Deviation|Mean
680072|NCT01573910|Primary|Microbiological Success Rate|Microbiological specimen(s) from the affected eye(s) were collected according to a protocol-defined process. Microbiological success rate is presented as the percentage of participants for which the pre-therapy pathogens at Visit 1 (Day 1) were eradicated at Day 9 TOC/Exit Visit.|Day 9|This analysis population includes all patients who received study medication, had no major protocol deviations, had bacteria present at Day 1 visit, and had baseline and TOC/exit data or early exit data.||percentage of participants|||Number
680073|NCT01573910|Primary|Clinical Cure Rate|Ocular signs of bacterial conjunctivitis (bulbar conjunctival injection and conjunctival discharge/exudates) were rated by the investigator on a 4-point scale, with 0=normal/absent; 1=mild; 2=moderate, and 3=severe. Clinical cure rate is presented as the percentage of participants for which the sum of the numerical scores for the 2 cardinal ocular signs of bacterial conjunctivitis was 0 at Day 9 TOC/Exit Visit.|Day 9|This analysis population includes all patients who received study medication, had no major protocol deviations, had bacteria present at Day 1 visit, and had baseline and TOC/exit data or early exit data.||percentage of participants|||Number
680074|NCT01573767|Secondary|Change From Baseline in the Percentage of Symptom-free 24-hour Periods During the 4-week Treatment Period|Asthma symptoms were recorded in a daily eDairy by the participants every day in the morning and evening before taking any rescue or study medication and before the PEF measurement. A 24-hour (hr) period in which a participant’s responses to both the morning and evening assessments indicated no symptoms was considered to be symptom free. The Baseline symptom-free value is defined as the value at Visit 3 (randomization). Change from Baseline was calculated as the averaged value during the 4-week Treatment Period minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment group.|Baseline; Week 1 up to Week 4|ITT Population. Only those participants available at the specified time points were analyzed.||Percentage of symptom-free 24-hr periods||Standard Error|Least Squares Mean
680075|NCT01573767|Secondary|Change From Baseline in AM PEF Over the Last 7 Days of the Treatment Period (Week 4)|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline is calculated as the value of the averaged daily AM PEF over the 4-week Treatment Period (at Week 4) minus the Baseline value. The Baseline value is defined as the value at Visit 3 (randomization). The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment group.|Baseline; Week 4|ITT Population. Only those participants available at the specified time points were analyzed.||L/min||Standard Error|Least Squares Mean
680076|NCT01573767|Secondary|Change From Baseline in Evening (PM) PEF Over the Last 7 Days of the Treatment Period (Week 4)|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline is calculated as the value over the last 7 days of the Treatment Period minus the Baseline value. The Baseline value is defined as the value at Visit 3 (randomization). The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment group. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement at scheduled clinic visits was used to impute the missing measurements.|Baseline; Week 4|ITT Population. Only those participants available at the specified time points were analyzed.||L/min||Standard Error|Least Squares Mean
680077|NCT01573767|Secondary|Change From Baseline in Daily Morning (AM) PEF Averaged Over the 4-week Treatment Period|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline was calculated as the value of the averaged daily AM PEF over the 4-week Treatment Period (at Week 4) minus the Baseline value. The Baseline value is defined as the value at Visit 3 (randomization). The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment group.|Baseline; Week 1 up to Week 4|ITT Population. Only those participants available at the specified time points were analyzed.||L/min||Standard Error|Least Squares Mean
680162|NCT01572740|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 16|Estimated mean change from baseline in FPG after 16 Weeks of treatment.|Week 0, Week 16|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial products. Missing data were imputed using last observation carried forward (LOCF). 1 subject in the placebo group did not contribute to the statistical analysis at Week 16 as subject was withdrawn from the trial before sampling for any efficacy data.||mmol/L||Standard Error|Mean
680078|NCT01573767|Secondary|Change From Baseline in the Percentage of Rescue-free 24-hour Periods During the 4-week Treatment Period|The number of inhalations of rescue albuterol/salbutamol inhalation aerosol (medication used to relieve symptoms immediately) used during the day and night) was recorded by the participants in a daily diary. A 24-hour period in which a participant’s responses to both the morning and evening assessments indicated no use of rescue medication was considered as rescue free. Participants who were rescue free for 24-hour periods during the 4-week Treatment Period were assessed. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline is calculated as the average value during the 4-week Treatment Period minus the value at Baseline. The Baseline value is defined as the value at Visit 3 (randomization). Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|Baseline; Week 1 up to Week 4|ITT population. Only those participants available at the specified time points were analyzed.||Percentage of rescue-free 24-hr periods||Standard Error|Least Squares Mean
680079|NCT01573767|Secondary|Change From Baseline in Evening Clinic Visit Trough (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 4-week Treatment Period in Children Who Could Perform the Maneuver|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is defined as a pre-dose FEV1 measurement taken at a clinic visit while still on treatment. Change from Baseline in trough FEV1 at the end of the 4-week Treatment Period was defined using the pre-dose FEV1 measurement taken at the Week 4 clinic visit. Change from Baseline was calculated as the Week 4 trough FEV1 value minus the Baseline value. The Baseline FEV1 value is defined as the value at Visit 3 (randomization). The analysis was performed using an ANCOVA model with covariates of Baseline trough FEV1, region, sex, age, and treatment. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement at scheduled clinic visits was used to impute the missing measurements.|Baseline; Week 4|ITT Population. Only those participants available at the specified time points were analyzed.||Liters||Standard Error|Least Squares Mean
680080|NCT01573767|Primary|Change From Baseline in Daily Pre-dose Evening (PM) Peak Expiratory Flow (PEF) From Participant Electronic Daily Diary Averaged Over the 4-week Treatment Period|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use each morning. The best of three measurements was recorded. Change from Baseline was calculated as the value of the averaged daily PM PEF over the 4-week Treatment Period minus the Baseline value. The Baseline PEF value is defined as the average of the last 7 days of the Run-in Phase. The analysis was performed using an analysis of covariance (ANCOVA) model with covariates of Baseline, region, sex, age, and treatment. Only those participants contributing data per the daily eDiary were analyzed.|Baseline; Week 1 up to Week 4|ITT Population: participants randomized to treatment who received >=1 dose of study medication||Liters per minute (L/min)||Standard Error|Least Squares Mean
680081|NCT01573624|Secondary|Mean Change From Baseline in Rescue Albuterol/Salbutamol Use of Each Treatment Period.|Short-Acting Beta2-Agonists albuterol/salbutamol was provided to participants as rescue medication, to use in morning and evening. Participants recorded number of puffs of salbutamol MDI used in last 24 hours (sum of night time and day time puffs) daily for relief of symptoms in eDiary. Mean change from baseline was calculated where, baseline was defined as measurement from (Week 0), includes Day 1 and six days immediately preceding Day 1 (for night time puffs) and seven days (for day time puffs) for each treatment period. Change from baseline values for each participant in each treatment period were differences between on-treatment week (last 7 days of each treatment period) values and the baseline week. Analysis was done using a mixed model, including treatment, period, period baseline rescue albuterol use, and mean baseline rescue albuterol use as fixed effects and participant as random effect. A post hoc analysis was performed to confirm nullification of carry over effect of UMEC.|Baseline (Week 0) and last 7 days of each treatment period|ITT Population. Only those participants with data available at the indicated time points were analyzed.||Number of puffs||Standard Error|Least Squares Mean
680082|NCT01573624|Secondary|Mean Change From Baseline in Daily Evening (Pre-dose and Pre-rescue Bronchodilator) PEF of Each Treatment Period|PEF is a measure of lung function and measures how fast a person can breathe out. Evening PEF was measured pre-dose and pre-rescue bronchodilator use with an electronic Peak Flow Meter. Participants were issued an electronic diary (eDiary) for daily use throughout the study and instructed on how to complete it. Best of 3 attempts were recorded in eDiary. Mean change from baseline was calculated where, baseline was defined as the measurement from (Week 0), includes Day 1 and seven days immediately preceding Day 1 for each treatment period. The change from baseline values for each participant in each treatment period were differences between on-treatment week (last 7 days of each treatment period) values and baseline week. Analysis was done using a mixed model, including treatment, period, period baseline evening PEF and mean baseline evening PEF as fixed effects and participant as a random effect. A post hoc analysis was performed to confirm nullification of carry over effect of UMEC.|Baseline (Week 0) and last 7 days of each treatment period|ITT Population. Only those participants with data available at the indicated time points were analyzed.||L/min||Standard Error|Least Squares Mean
680083|NCT01573624|Secondary|Mean Change From Baseline in Daily Morning (Pre-dose and Pre-rescue Bronchodilator) Peak Expiratory Flow (PEF) of Each Treatment Period|PEF is a measure of lung function and measures how fast a person can breathe out. Morning PEF was measured pre-dose and pre- rescue bronchodilator use with an electronic Peak Flow Meter. Participants were issued an electronic diary (eDiary) for daily use throughout the study and instructed on how to complete it. Best of 3 attempts were recorded in eDiary. Mean change from baseline was calculated where, baseline was defined as the measurement from (Week 0), includes Day 1 and six days immediately preceding Day 1 for each treatment period. The change from baseline values for each participant in each treatment period were differences between on-treatment week (last 7 days of each treatment period) values and baseline week. Analysis was done using a mixed model, including treatment, period, period baseline morning PEF and mean baseline morning PEF as fixed effects and participant as a random effect. A post hoc analysis was performed to confirm nullification of carry over effect of UMEC.|Baseline (Week 0) and last 7 days of each treatment period|ITT Population. Only those participants with data available at the indicated time points were analyzed.||Litres per min (L/min)||Standard Error|Least Squares Mean
680084|NCT01573624|Primary|Mean Change From Baseline in Trough FEV1 on Day 15 of Each of the 3 Treatment Periods|FEV1 is a lung function measure defined as the maximal amount of air that can be forcefully exhaled in one second. The highest FEV1 from the 3 acceptable spirometric efforts were recorded between 5.00 AM and 11.00 AM after withholding albuterol (salbutamol) at all visits for at least 4 hours. Baseline was defined as the pre- dose FEV1 value obtained on Day 1 and trough was defined as the FEV1 value obtained 24 hours after morning dosing on Day 14 of each treatment period. The change from baseline value for each participant in each treatment period was the difference between the observed on-treatment value obtained 24 hours after morning dosing on Day 14 and the baseline value for that period. Analysis was done using a mixed model, including treatment, period, period baseline FEV1, and mean baseline FEV1 as fixed effects and participant as a random effect. A post hoc analysis was performed to confirm nullification of carry over effect of UMEC.|Baseline (Day 1) and Day 15 of each treatment period|ITT Population. Only those participants with data available at the indicated time points were analyzed.||Litres (L)||Standard Error|Least Squares Mean
680085|NCT01573624|Primary|Percentage of Chance That FF 100 mcg Alone Corrected Change From Baseline FEV1 Response Would Exceed a Target Response by Dose of UMEC Combined With FF 100 mcg|FEV1 is a lung function measure defined as the maximal amount of air that can be forcefully exhaled in one second. Highest FEV1 from the 3 acceptable spirometric efforts were recorded between 5.00 AM and 11.00 AM after withholding albuterol (salbutamol) at all visits for at least 4 hours. Baseline was defined as the pre- dose FEV1 value obtained on Day 1 and trough was defined as FEV1 value obtained 24 hours after morning dosing on Day 14 of each treatment period. Change from baseline value for each participant in each treatment period was the difference between the observed on-treatment value obtained 24 hours after morning dosing on Day 14 and the baseline value for that period. Data is presented as percentage chance that FF 100 mcg alone corrected change from baseline trough FEV1 response would exceed a target response of 50 mL, 75 mL, 100 mL and 150 mL by doses of UMEC combined with FF 100 mcg.|Baseline (Day 1) and Day 15 of each treatment period|ITT Population. Only those participants with data available at the indicated time points were analyzed.||Percentage chance|||Number
680086|NCT01573624|Primary|Model Predicted Change From Baseline Trough Force Expiratory Volume in 1 Second (FEV1)|FEV1 is a lung function measure defined as the maximal amount of air that can be forcefully exhaled in one second. Highest FEV1 from the 3 acceptable spirometric efforts were recorded between 5.00 ante meridiem (AM) and 11.00 AM after withholding albuterol (salbutamol) at all visits for at least 4 hours. Baseline was defined as the pre- dose FEV1 value obtained on Day 1 and trough was defined as FEV1 value obtained 24 hours after morning dosing on Day 14 of each treatment period. Change from baseline value for each participant in each treatment period was the difference between the observed on-treatment value obtained 24 hours after morning dosing on Day 14 and the baseline value for that period. Slope-intercept on log dose model was used to predict trough FEV1 change from baseline for each of the FF+UMEC doses adjusted by FF 100 mcg alone. Mean value for the expected response and associated 95% confidence interval (CI) in change from baseline trough FEV1 is presented.|Baseline (Day 1) and Day 15 of each treatment period|The primary endpoint was analyzed using Intent -to -Treat (ITT) Population defined as all participants randomized to treatment and who received at least one dose of study medication. Only those participants with data available at the indicated time points were analyzed.||Litres (L)||95% Confidence Interval|Mean
680087|NCT01573325|Secondary|Percentage of Subjects With Depressive Scores Who Had a Poor HRQoL|Identify clinical characteristics such as environmental factors, patient biology, liver-disease related symptoms, functional status, general health perception, characteristics of the individual associated with perceived HRQoL in patients with low MELD scores (≤15) pre-transplant. What characteristics were found to be predictive of poor HRQoL. Tools utilized each assessed the specific variables including patient biology, liver disease symptoms, functional status, general health perception, and characteristics of the individual.|2-3 months|Entire study population was analyzed||percentage of participants|||Number
680088|NCT01573325|Primary|Perceived HRQoL Score. Overall Qualty of Life Index Tool Was Utilized.|Describe perceived HRQoL in patients with low MELD scores (≤15) pre-liver transplant patient population. Overall Qualty of Life Index tool was utilized. The subscales were not utilized. The unit of measurement was scores on a scale. QLI tool has a range of 0-30 for total possible score. With the higher the score the higher the HRQoL.|2-3 months|Entire study population was analyzed||scores on a scale||Standard Deviation|Mean
680089|NCT01573260|Secondary|Adverse Events|Adverse events will be queried week 12 through a semi structured interview querying increase in falls, fatigue, pain, cramps or pain, in addition to open-ended questions regarding other potential adverse events. Events will be rated by the patient and investigator as mild, moderate, or serious. All serious adverse events will be reported to the research ethics board|12 weeks|||percentage of participants|||Number
680090|NCT01573260|Secondary|Exit Questionnaire|An exit questionnaire ranking level of enjoyment and overall satisfaction with their dance/exercise program, scored from 1 (strongly agree) to 5 (strongly disagree), with open questions about willingness continuing practicing tango.|12 weeks|||units on a scale||Standard Deviation|Mean
680091|NCT01573260|Secondary|Clinical Global Impression of Change|"Completed by both the examiner and the patient, the scale is a single question Since you have enrolled in the study, how has your Parkinson's disease changed?. It will be scored as very much improved (6), much improved (5), minimally improved (4), no change (3), minimally worse (2), much worse (1), or very much worse(0)."|26 weeks|||units on a scale||Standard Deviation|Mean
680092|NCT01573260|Secondary|Adherence to Treatment|Compliance with dance therapy will be conducted by reconfirming the regular assistance to the dance sessions at week 12, to compare how many sessions were attended by the participants. The dance instructors will keep the track of dance classes’ assistance.|12 weeks|||participants|||Number
680093|NCT01573260|Secondary|The Parkinson's Disease Questionnaire is a Quality of Life(PDQ-39)|The PDQ-39 is a quality of life index for PD. It consists of a 39-item questionnaire that asks about the impact of PD on a person's motor function, gait, mood, cognition, and activities of daily living. Patients are asked to indicate the frequency of each event by selecting one of 5 options: never/occasionally/sometimes/often/always or cannot do at all. Total score is ranging from 0 (best possible outcome) to 156 (worst possible quality of life).|26 weeks|||score||Standard Deviation|Mean
680744|NCT01565889|Primary|Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)|The percentage of participants discontinuing any study drug due to an adverse event was summarized.|Up to 12 weeks|Safety Analysis Set: participants who received at least 1 dose of study drug(s)||percentage of participants|||Number
680097|NCT01573260|Secondary|The Montreal Cognitive Assessment|"This tool was designed to screen for mild cognitive impairment. This includes visuospatial tests (clock drawing, trail making, cube copying), confrontation naming, attention (digit span, backwards digit span, A test, sentence repetition), tests of verbal fluency, abstraction, short term memory, and orientation. Recently, it has been used widely in PD, and demonstrates excellent sensitivity for subtle cognitive deficits. Alternate versions (7.1 to 7.3, with a randomly-distributed order) will be administered to prevent training effects. Total score for the MoCA is the sum of eight subscales, ranging from 0 (worst possible outcome) to 30 (best possible symptoms)"|26 weeks|||score||Standard Deviation|Mean
680098|NCT01573260|Secondary|The Purdue Pegboard|The Purdue Pegboard, a test of dexterity and speed in the hands will be assessed over 1 minute. We calculate the number of pins correctly placed on the board in a minute.|26 weeks|||correct pins per 60 sec||Standard Deviation|Mean
680099|NCT01573260|Secondary|Freezing of Gait Questionnare (FOG_Q)|Freezing of gait will be assessed using the Freezing of Gait Questionnare (FOG_Q), a 6-item tool measuring walking and freezing episodes. Higher scores indicate greater difficulty with walking and freezing. Six items each scored from 0 to 6 were summed to obtain the total score, ranging from 0 (best possible outcome) to 36 (worst possible outcome).|26 weeks|||units on a scale||Standard Deviation|Mean
680100|NCT01573260|Secondary|Number of Participants With a Fall in the Past 3 Months Using the Falls Questionnaire From the Canadian Longitudinal Study of Aging|Falls will be assessed using an adapted version of the falls questionnaire from the Canadian Longitudinal Study of Aging focusing on the past 3 months. This questionnaire includes 2 questions to assess if the participants felt during the past year and then it assess if this fall happened within the last 3 months. If a participant answered 'yes' to both questions, then the participant screened positive for this outcome. In the results section, we reported the number of participant who answered 'Yes' to both questions.|26 weeks|||participants|||Number
680101|NCT01573260|Secondary|MiniBESTest|Balance will be assessed using a 14-item tool measuring performance of dynamic balance tasks. This test has high interrater and test-retest reliability in PD (intraclass correlation coefficient ≥ .92 and intraclass correlation coefficient ≥.88 respectively). Total score for MiniBESTest is the sum of foursubscales, ranging from 0 (worst possible balance) to 28 (best possible balance). Lower scores indicate greater deficits in balance. Two items have right and left assessment in which the lower score is used within the total score (directions specify which to use). For research, we used of both left and right data, thus calculating data based on 32 (vs 28) points.|26 weeks|||units on a scale||Standard Deviation|Mean
680102|NCT01573260|Primary|Severity of PD (Unified Parkinson Disease Rating Scale - UPDRS, 2008 Version)|This is the standard scale used for grading severity of PD. It starts with a patient self-administered questionnaire covering activities of daily living, motor symptoms, and non-motor domains. It also includes a systematic rated clinical interview assessing cognitive and psychiatric symptoms and motor complications of disease. A Hoehn and Yahr scale (5-point overall disease severity index) is included. Finally, there is a formal examination component (Part III) (performed in the medication 'on' state for this study). Total score for Unified Parkinson Disease Rating Scale is the sum of six subscales, ranging from 0 (best possible outcome) to 60 (worst possible symptoms)|26 weeks|||units on a scale||Standard Deviation|Mean
680103|NCT01573000|Secondary|Time to Human Anti-Murine Antibodies (HAMA) Positivity From the First Dosimetric Dose|Tositumomab is a murine (mouse) antibody (immunoglobulin) of the IgG2a subclass. Participants in this study were evaluated to determine whether they developed an immune response to study treatment as evident by human anti-mouse antibodies (HAMA) after administration of tositumomab and iodine I 131 tositumomab. A positive HAMA value indicates that the participant developed human anti-mouse antibodies above the HAMA assay threshold, and a negative HAMA value indicates either the absence or below threshold level of human anti-mouse antibodies.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. Participants who converted from being negative for HAMA at Baseline to being positive for HAMA following treatment were evaluated.||days||Standard Deviation|Mean
680104|NCT01573000|Secondary|Duration of the Indicated Grade 3 or Grade 4 Hematologic Toxicities|Adverse events were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No adverse event or within normal limits; 1 = Mild adverse event; 2 = Moderate adverse event; 3 = Severe and undesirable adverse event; 4 = Life-threatening or disabling adverse event; 5 = Death related to adverse event.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|"ITT-Exposed Population. All participants with Grade 3 or Grade 4 hematologic toxicities were analyzed. The n in the category titles reflects the number of participants with the indicated Grade 3 or Grade 4 hematologic toxicity."||days||Full Range|Median
680105|NCT01573000|Secondary|Number of Participants With the Indicated Grade 3 or Grade 4 Hematologic Toxicities|Adverse events were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No adverse event or within normal limits; 1 = Mild adverse event; 2 = Moderate adverse event; 3 = Severe and undesirable adverse event; 4 = Life-threatening or disabling adverse event; 5 = Death related to adverse event.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population||participants|||Number
680106|NCT01573000|Secondary|Nadir Values for the Hematologic Parameters Platelets and WBC Count|Nadir is defined as the lowest laboratory value recorded following the administration of study medication. Platelets and WBCs are types of blood cells.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population||cells/microliter||Full Range|Median
680107|NCT01573000|Secondary|Nadir Values for Hemoglobin, a Hematologic Parameter|Nadir is defined as the lowest laboratory value recorded following the administration of study medication. Hemoglobin is the iron-containing oxygen-transport metalloprotein in the red blood cells.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population||Grams/dL||Full Range|Median
680174|NCT01572675|Secondary|Number of Participants Who Experienced at Least One Adverse Event|An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.|Up to 12 months|The safety population consisting of all participants who enrolled in the study||Participants|||Number
680108|NCT01573000|Primary|Number of Participants With Confirmed Partial Response (PR) Before and After Crossover From Unlabeled TST to TST and Iodine I 131 TST as Assessed by the Investigator|Participants receiving Unlabeled TST with progressive disease were assessed separately before and after receiving the crossover treatment of I 131 TST confirmed PR. Confirmed PR is defined as a >=50 percent reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions, with no new lesions.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. All participants receiving Unlabeled TST who received the crossover treatment were analyzed.||participants|||Number
680109|NCT01573000|Secondary|Nadir Values for ANC, a Hematologic Parameter|Nadir is defined as the lowest laboratory value recorded following the administration of study medication. ANC is a measure of the number of neutrophil granulocytes present in the blood. Neutrophils are a type of white blood cell that fights against infection.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. All participants with hematological toxicity were evaluated.||Cells/millimeters cubed (mm^3)||Full Range|Median
680110|NCT01573000|Secondary|Time to Nadir and Time to Recovery to Baseline in Hematologic Laboratory Evaluations|Nadir is defined as the lowest laboratory value recorded following the administration of the study medication. Time to recovery to baseline in hematologic laboratory evaluations is the time required for recovery from nadir values to baseline values. Hematologic laboratory evaluations included ANC, hemoglobin (Hb), platelets (Plt), and WBC count.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. All participants with hematological toxicity were evaluated. The numbers analyzed in the category titles reflect the number of participants with the event of interest plus the number of participants who were censored. A censored value indicates that the participant did not have the event of interest.||days||Full Range|Median
680111|NCT01573000|Secondary|Number of Participants With the Indicated Fatal SAEs Related to Study Drug|An SAE is any event occurring at any dose that results in any of the following: death, a life-threatening adverse drug experience (ADE; at immediate risk of death from the experience as it occurred), inpatient hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, or a congenital anomaly/birth defect. Medical events that may not result in death, be life-threatening, or require hospitalization may be considered to be a serious ADEs when based upon appropriate medical judgment. Relatedness was based on the investigator's medical judgement.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. All participants who experienced any fatal SAE were analyzed.||participants|||Number
680112|NCT01573000|Secondary|Number of Participants With the Indicated Serious Adverse Events (SAE) Related to Study Drug|An SAE is any event occurring at any dose that results in any of the following: death, a life-threatening adverse drug experience (ADE; at immediate risk of death from the experience as it occurred), inpatient hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, or a congenital anomaly/birth defect. Medical events that may not result in death, be life-threatening, or require hospitalization may be considered to be a serious ADEs when based upon appropriate medical judgment. Relatedness was based on the investigator's medical judgement.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. All participants who experienced any SAE were analyzed.||participants|||Number
680113|NCT01573000|Secondary|Number of Participants With a Time to Death From the Last Dose of Study Drug Less Than or Equal to 30 Days or More Than 30 Days|"Time to death from the last dose of study drug is the time from the last dose of study drug administered to the date of death. Deaths due to progressive disease or to another reason (Other) were not captured as serious adverse events (SAEs) and are thus not included in the SAE module."|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. All participants who died by the completion of LTFU were analyzed.||participants|||Number
680114|NCT01573000|Secondary|Number of Participants With the Indicated Primary Cause of Death|"Participants were categorized according to their primary cause of death. Deaths due to progressive disease or to another reason (Other) were not captured as serious adverse events (SAEs) and are thus not included in the SAE module."|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. All participants who died by the completion of LTFU were analyzed.||participants|||Number
680115|NCT01573000|Secondary|Number of Participants With the Indicated Grade 3 or Grade 4 Drug-related AEs Experienced by 3 or More Participants|AEs were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No adverse event or within normal limits; 1 = Mild adverse event; 2 = Moderate adverse event; 3 = Severe and undesirable adverse event; 4 = Life-threatening or disabling adverse event; 5 = Death related to adverse event.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. All participants with any Grade 3 or Grade 4 drug-related AEs experienced by 3 or more participants were analyzed.||participants|||Number
680116|NCT01573000|Secondary|Number of Participants With the Indicated Grade 3 or Grade 4 AEs Experienced by 3 or More Participants|AEs were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No adverse event or within normal limits; 1 = Mild adverse event; 2 = Moderate adverse event; 3 = Severe and undesirable adverse event; 4 = Life-threatening or disabling adverse event; 5 = Death related to adverse event.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. All participants with any Grade 3 or Grade 4 AEs experienced by 3 or more participants were analyzed.||participants|||Number
680117|NCT01573000|Secondary|Number of Participants With an Infection for Which Anti-infectives Were Administered|Anti-infectives are capable of acting against infection, by inhibiting the spread of an infectious agent or by killing the infectious agent outright. Anti-infective is a general term that encompasses antibacterials, antibiotics, antifungals, antiprotozoans, and antivirals.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. Only those participants who had an infection during the study and during the follow-up period were analyzed.||participants|||Number
680118|NCT01573000|Secondary|Number of Participants With the Indicated Type of Infection|An infection is the colonization of a host organism by a parasite species. Infecting parasites seek to use the host's resources to reproduce, often resulting in disease. Specimen samples of the body fluid are cultured for testing whether the infectious organism is present and grown in the culture media to assess the growth pattern of the organisms present in the specimen. The culture results could be positive or negative. The positive culture results indicate that the tested participant has the infection under investigation, in which case therapeutic treatment with anti-infective is required.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population||participants|||Number
680119|NCT01573000|Secondary|Number of Participants With the Indicated Drug-Related (DR) Adverse Events (AEs) Experienced by 3 or More Participants|"An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Causality of AEs was determined by the investigators as none, remote, possible, probable, or highly probable. AEs considered by the investigator as being at least remotely related to the study treatment were considered to be DR AEs. White blood cell (WBC) count and absolute neutrophil count (ANC) were measured as cells per millimeters cubed (mm^3); hemoglobin was measured in grams per deciliter (g/dL)."|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. All participants with any drug-related adverse events were analyzed.||participants|||Number
680120|NCT01573000|Secondary|Overall Survival|Overall survival is defined as the time from the treatment start date to the date of death by any cause.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. Only those participants who died during the study and during the follow-up period were analyzed.||months||95% Confidence Interval|Median
680121|NCT01573000|Secondary|MIRROR Panel Assessed Progression-free Survival|Time from the date of enrollment (the date of randomization) to the first documented progression or death.|The MIRROR panel reviewed responses of participants from 17 July 1998 to 17 January 2001|ITT-Exposed Population. Only those participants evaluable for confirmed response were analyzed.||months||95% Confidence Interval|Median
680122|NCT01573000|Secondary|MIRROR Panel Assessed Time to Response (Time From the Date of Enrollment to the First Documented Response (PR, CR, CCR)|Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Par. with confirmed response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).|The MIRROR panel reviewed responses of participants from 17 July 1998 to 17 January 2001|ITT-Exposed Population. Only those participants evaluable for confirmed response were analyzed.||days||95% Confidence Interval|Median
680123|NCT01573000|Secondary|Time to Progression of Disease or Death in Participants Before and After Crossover From Unlabeled TST to TST and Iodine I 131 TST as Assessed by the Investigator|Progression-free survival or time to progression is defined as the time from the dosimetric dose to the first documented occurrence of disease progression or death.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. All participants receiving Unlabeled TST who received the crossover treatment and those who progressed/died were analyzed. Participants who experienced progression or died (n=18, 17) and participants who were censored (n=1, 2) were analyzed. A censored value indicates that the participant did not have the event of interest.||months||95% Confidence Interval|Median
680124|NCT01573000|Secondary|Time to Progression of Disease or Death as Assessed by the Investigator|Progression-free survival or time to progression is defined as the time from the dosimetric dose to the first documented occurrence of disease progression or death.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. Participants who experienced progression or died (n=36, 33) and participants who were censored (n=6, 3) were analyzed. A censored value indicates that the participant did not have the event of interest.||months||95% Confidence Interval|Median
680125|NCT01573000|Secondary|MIRROR Panel Assessments of Duration of Confirmed Response (Time From the First Documented Response to the First Documented Progression)|Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Par. with confirmed response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).|The MIRROR panel reviewed responses of participants from 17 July 1998 to 17 January 2001|ITT-Exposed Population. Only those participants evaluable for confirmed response were analyzed.||months||95% Confidence Interval|Median
680126|NCT01573000|Secondary|MIRROR Panel Assessments of Duration of Complete Response (Time From the First Documented Response to the First Documented Progression)|Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Par. with confirmed response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).|The MIRROR panel reviewed responses of participants from 17 July 1998 to 17 January 2001|Intent-to-Treat (ITT) Exposed Population: all participants who were enrolled into the study and received at least one dose of study drug. Only those participants evaluable for confirmed response were analyzed.||months||95% Confidence Interval|Median
680187|NCT01572675|Primary|Type of Arcoxia® and Celebrex® Use|The type of Arcoxia® or Celebrex® use during the study was classified as continuous (without interruption >7 days) or intermittent (with interruption >7 days) by the Investigating Physician at time of treatment discontinuation.|Up to 12 months|All participants who discontinued treatment during follow-up under protocol; participants who were lost to follow-up were excluded from this analysis.||Participants|||Number
680127|NCT01573000|Secondary|Duration of Response for All Confirmed Responders, Confirmed Complete Responders, and Confirmed Partial Responders|For all participants with CR, CCR, or PR, duration of response was defined as the time from first documented response to first documented progression. All confirmed responders included participants with CR, CCR, and PR, whereas confirmed complete responders included participants with CR and CCR.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. Only those participants evaluable for CR, CCR, or PR were analyzed.||months||95% Confidence Interval|Median
680128|NCT01573000|Secondary|Number of Participants (Par.) With a Confirmed Response (CR, CCR, or PR) as Assessed by the MIRROR Panel|Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Par. with confirmed response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).|The MIRROR panel reviewed responses of participants from 17 July 1998 to 17 January 2001|ITT-Exposed Population. Only those participants evaluable for confirmed response were analyzed.||participants|||Number
680129|NCT01573000|Primary|Number of Participants With Confirmed Partial Response (PR) as Assessed by the Investigator|Confirmed PR is defined as a >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions, with no new lesions.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. Only those participants evaluable for confirmed response were analyzed.||participants|||Number
680130|NCT01573000|Primary|Number of Participants With Confirmed Complete Response Plus Clinical Complete Response (CR + CCR) Before and After Crossover From Unlabeled TST to TST and Iodine I 131 TST as Assessed by the Investigator|Participants receiving Unlabeled TST with progressive disease were assessed separately before and after receiving the crossover treatment of I 131 TST for CR + CCR.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. All participants receiving Unlabeled TST who received the crossover treatment were analyzed.||participants|||Number
680131|NCT01573000|Primary|Number of Participants With Confirmed Complete Response Plus Clinical Complete Response (CR + CCR) as Assessed by the Investigator|CCR is defined as the complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present. Generally, an unchanging lesion =<2 cm in diameter by radiographic evaluation or =<1 cm in diameter by physical examination can be considered scar tissue. The extent of disease must be unchanged or decreased upon follow-up evaluations. If the extent of disease was unchanged or if further decreases occurred for 6 months or longer, the participant was reclassified as having a CR.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. Only those participants evaluable for confirmed response were analyzed.||participants|||Number
680132|NCT01573000|Primary|Number of Participants With Confirmed Clinical Complete Response (CCR) Before and After Crossover From Unlabeled TST to TST and Iodine I 131 TST as Assessed by the Investigator|Participants receiving Unlabeled TST with progressive disease were assessed separately before and after receiving the crossover treatment of I 131 TST for CCR. CCR is defined as the complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present. Generally, an unchanging lesion =<2 cm in diameter by radiographic evaluation or =<1 cm in diameter by physical examination can be considered scar tissue.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. All participants receiving Unlabeled TST who received the crossover treatment were analyzed.||participants|||Number
680133|NCT01573000|Primary|Number of Participants With Confirmed Clinical Complete Response (CCR) as Assessed by the Investigator|CCR is defined as the complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present. Generally, an unchanging lesion =<2 cm in diameter by radiographic evaluation or =<1 cm in diameter by physical examination can be considered scar tissue.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. Only those participants evaluable for confirmed response were analyzed.||participants|||Number
680134|NCT01573000|Primary|Number of Participants With Confirmed Complete Response (CR) Before and After Crossover From Unlabeled TST to TST and Iodine I 131 TST as Assessed by the Investigator|Participants receiving Unlabeled TST with progressive disease were assessed separately before and after receiving the crossover treatment of I 131 TST for CR. CR is defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. All participants receiving Unlabeled TST who received the crossover treatment were analyzed.||participants|||Number
680135|NCT01573000|Primary|Number of Participants (Par.) With a Confirmed Complete Response as Assessed by the Masked Independent Randomized Radiology and Oncology Review (MIRROR) Panel|Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Par. with confirmed response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).|The MIRROR panel reviewed responses of participants from 17 July 1998 to 17 January 2001|ITT-Exposed Population. Only those participants evaluable for confirmed response were analyzed.||participants|||Number
680136|NCT01573000|Primary|Number of Participants With Confirmed Complete Response (CR) as Assessed by the Investigator|CR is defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. Only those participants evaluable for confirmed response were analyzed.||participants|||Number
681090|NCT01562314|Secondary|Clinical Efficacy Blood Sample Measurements - IL-6|Change in serum cytokine, IL-6 from Baseline to Final Visit|Baseline to end of treatment (10 week treatment period)|ITT analysis set||ng/L||Standard Deviation|Mean
680137|NCT01573000|Primary|Number of Participants With Confirmed Response Before and After Crossover From Unlabeled TST to TST and Iodine I 131 TST as Assessed by the Investigator|Participants receiving Unlabeled TST with progressive disease (defined as a >=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measureable lesions or the appearance of any new lesion. Individual lesions must be >2 centimeters [cm] in diameter by radiographic evaluation or >1 cm in diameter by physical examination.) were assessed separately before and after receiving the crossover treatment of I 131 TST for confirmed response, which included participants with CR, CCR, and PR.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. All participants receiving Unlabeled TST who received the crossover treatment were analyzed.||participants|||Number
680138|NCT01573000|Primary|Number of Participants (Par.) With Confirmed Response as Assessed by the Investigator|Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Par. with confirmed response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|Intent-to-Treat (ITT) Exposed Population: all participants who were enrolled into the study and received at least one dose of study drug. Only those participants evaluable for confirmed response were analyzed.||participants|||Number
680139|NCT01572948|Secondary|Induced Sputum Neutrophil Count||3 months after baseline|||percentage of sputum neutrophils||Standard Error|Mean
680140|NCT01572948|Secondary|Induced Sputum Neutrophil Count||baseline|||percentage of sputum neutrophils||Standard Error|Mean
680141|NCT01572948|Primary|Mean Induced Sputum Proline-glycine-proline (PGP) Levels at 3 Months After Randomization||3 months after baseline|||ng/ml||Standard Deviation|Mean
680142|NCT01572948|Primary|Mean Induced Sputum Proline-glycine-proline (PGP) Levels at 1 Month After Randomization.||1 month after baseline|||ng/ml||Standard Deviation|Mean
680143|NCT01572948|Secondary|Induced Sputum Neutrophil Count||1 month|||percentage of sputum neutrophils||Standard Error|Mean
680144|NCT01572948|Primary|Induced Sputum Proline-glycine-proline (PGP) Levels at Baseline||baseline|||ng/ml||Standard Deviation|Mean
680145|NCT01572792|Secondary|Percentage of Patients to Experience Potentially Clinically Significant Post-baseline Vital Signs (Pulse Rate, Systolic or Diastolic Blood Pressure or Weight)|"Potentially clinically significant change:
Systolic BP ≥180 mmHg and increase ≥20 mmHg from baseline or ≤90 mmHg and decrease ≥20 mmHg from baseline Diastolic BP ≥105 mmHg and increase ≥15 mmHg from baseline or ≤50 mmHg and decrease ≥15 mmHg from baseline Pulse rate ≥110 bpm and increase ≥15% from baseline or ≤50 bpm and decrease ≥15% from baseline Weight increase or decrease ≥7% from baseline
The last assessment made before the first dose of investigational product in the lead-in study was used as the baseline for all safety analyses in the extension study"|Baseline of lead-in study to end of treatment (up to Week 52)|The Extension Safety Population defined as all patients from the lead-in study (LAC-MD-31) who signed informed consent at Visit 1 of this extension study (last visit of the lead-in study) and who took at least 1 dose of double-blind investigational product in this extension study||Percentage of participants|||Number
680146|NCT01572792|Other Pre-specified|Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Total Score|St George's Respiratory Questionnaire (SGRQ) measures COPD-specific health outcomes and consists of 3 dimension scores (symptom, activity and impact). SGRQ total score is the sum of these scores and ranges from 0 (best health status) to 100 (worst health status).|Baseline of lead-in study to Week 52 of treatment|The Combined intent to treat (ITT) Population defined as all patients randomized to a treatment group who took at least 1 dose of double-blind investigational product in the lead-in study (LAC-MD-31) and who had a baseline assessment and at least 1 post-baseline assessment of forced expiratory volume in 1 second (FEV1) in LAC-MD-31||Scores on a scale||Standard Error|Least Squares Mean
680147|NCT01572792|Other Pre-specified|Transition Dyspnea Index (TDI) Focal Score at End of Study|"The TDI measures the change from baseline in severity of breathlessness in symptomatic patients. The TDI contains a rating for 3 categories (functional impairment, magnitude of task, magnitude of effort). TDI scale ranges from -3 (major deterioration) to +3 (major improvement) including a 0 score to indicate no change. The 3 categories are added to obtain a focal score ranging from -9 (including 0) to +9."|Baseline of lead-in study to Week 52 of treatment|The Combined intent to treat (ITT) Population defined as all patients randomized to a treatment group who took at least 1 dose of double-blind investigational product in the lead-in study (LAC-MD-31) and who had a baseline assessment and at least 1 post-baseline assessment of forced expiratory volume in 1 second (FEV1) in LAC-MD-31||Scores on a scale||Standard Error|Least Squares Mean
680148|NCT01572792|Other Pre-specified|Change From Baseline in Morning Predose (Trough) Forced Expiratory Volume in One Second (FEV1)||Baseline of lead-in study to Week 52 of treatment|The Combined intent to treat (ITT) Population defined as all patients randomized to a treatment group who took at least 1 dose of double-blind investigational product in the lead-in study (LAC-MD-31) and who had a baseline assessment and at least 1 post-baseline assessment of forced expiratory volume in 1 second (FEV1) in LAC-MD-31||Liters||Standard Error|Least Squares Mean
680149|NCT01572792|Other Pre-specified|Change From Baseline in 1-hour Morning Post-dose Forced Expiratory Volume in One Second (FEV1)||Baseline of lead-in study to Week 52 of treatment|The Combined intent to treat (ITT) Population defined as all patients randomized to a treatment group who took at least 1 dose of double-blind investigational product in the lead-in study (LAC-MD-31) and who had a baseline assessment and at least 1 post-baseline assessment of forced expiratory volume in 1 second (FEV1) in LAC-MD-31||Liters||Standard Error|Least Squares Mean
680150|NCT01572792|Secondary|Percentage of Patients to Experience a Potentially Significant Post-baseline 12-lead ECG Value||Baseline of lead-in study to end of treatment (up to Week 52)|The Extension Safety Population defined as all patients from the lead-in study (LAC-MD-31) who signed informed consent at Visit 1 of this extension study (last visit of the lead-in study) and who took at least 1 dose of double-blind investigational product in this extension study||Percentage of participants|||Number
680151|NCT01572792|Secondary|Percentage of Patients to Experience Potentially Clinically Significant Post-baseline Clinical Laboratory Values for Hematology, Chemistry or Urinalysis|"Potentially clinically significant change:
>1.15 × upper limit of normal (ULN) for absolute cell count of basophils, eosinophils or monocytes, blood alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, total bilirubin, blood urea nitrogen, total cholesterol, creatine kinase, creatinine, gamma glutamyl transferase, lactate dehydrogenase, triglycerides or uric acid <0.85 x lower limit of normal (LLN) or > 1.15 ULN for hematocrit ratio, haemoglobin, lymphocytes or neutrophils absolute cell count, platelet count (thrombocytes), red or white blood cell count, calcium, fasting glucose, phosphorus, total protein, or urinary pH <0.95 x LLN or >1.05 x ULN for chloride, potassium, sodium Urinary glucose ≥0.015, blood or ketones or protein ≥1 or specific gravity >1.1 × ULN
The last assessment made before the first dose of investigational product in the lead-in study was used as the baseline for all safety analyses in the extension study"|Baseline of lead-in study to end of treatment (up to Week 52)|The Extension Safety Population defined as all patients from the lead-in study (LAC-MD-31) who signed informed consent at Visit 1 of this extension study (last visit of the lead-in study) and who took at least 1 dose of double-blind investigational product in this extension study||Percentage of participants|||Number
680152|NCT01572792|Primary|Percentage of Patients to Experience Any Treatment-emergent Adverse Event|For each safety parameter, the last assessment made before the first dose of investigational product in the lead-in study (LAC MD-31) was used as the baseline for all analyses of that safety parameter in this extension study|Baseline of lead-in study to follow-up call 14±3 days after last dose of investigational product (up to Week 52)|The Extension Safety Population defined as all patients from the lead-in study (LAC-MD-31) who signed informed consent at Visit 1 of this extension study (last visit of the lead-in study) and who took at least 1 dose of double-blind investigational product in this extension study||Percentage of participants|||Number
680153|NCT01572740|Secondary|Number of Confirmed Hypoglycaemic Episodes|"A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and until the last day on randomised treatment. Confirmed hypoglycaemic episode was defined as hypoglycaemic episodes categorised to severe and/or minor hypoglycaemic episodes.
Confirmed hypoglycaemia: subject unable to treat himself/herself and/or have a recorded PG < 3.1 mmol/L (56 mg/dL). Minor: PG < 3.1 mmol/L (56 mg/dL)."|Week 0 to week 36 (inclusive)|Safety analysis set includes all subjects who received at least one dose of the trial products.||Episodes/100 years of patient exposure|||Number
680154|NCT01572740|Secondary|Number of Adverse Events (AEs)|An AE was defined as treatment emergent if the onset date was on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment.|Week 0 to Week 36 (inclusive)|Safety analysis set includes all subjects who received at least one dose of the trial products.||Events/100 years of patient exposure|||Number
680155|NCT01572740|Secondary|Change in Body Weight From Baseline to Week 36|Estimated mean change in body weight after 36 Weeks of treatment|Week 0, Week 36|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial products. Missing data were imputed using last observation carried forward (LOCF). 1 subject in the placebo group did not contribute to the statistical analysis at Week 36 as subject was withdrawn from the trial before sampling for any efficacy data.||kg||Standard Error|Mean
680156|NCT01572740|Secondary|Change in Body Weight From Baseline to Week 16|Estimated mean change in body weight after 16 Weeks of treatment|Week 0, Week 16|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial products. Missing data were imputed using last observation carried forward (LOCF). 1 subject in the placebo group did not contribute to the statistical analysis at Week 16 as subject was withdrawn from the trial before sampling for any efficacy data.||kg||Standard Error|Mean
680157|NCT01572740|Secondary|Change in Mean Prandial PG Increment of 7-Point Profile From Baseline to Week 36|Estimated mean change from baseline in mean prandial PG increment of 7-point profile (7-points were before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner and at bedtime) after 36 Weeks of treatment.|Week 0, Week 36|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial products. Missing data were imputed using last observation carried forward (LOCF). 13 subjects did not contribute to the statistical analysis at Week 36 due to missing data.||mmol/L||Standard Error|Mean
680158|NCT01572740|Secondary|Change in Mean Prandial PG Increment of 7-Point Profile From Baseline to Week 16|Estimated mean change from baseline in mean prandial PG increment of 7-point profile (7-points were before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner and at bedtime) after 16 Weeks of treatment.|Week 0, Week 16|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial products. Missing data were imputed using last observation carried forward (LOCF). 9 subjects did not contribute to the statistical analysis at Week 16 due to missing data.||mmol/L||Standard Error|Mean
680159|NCT01572740|Secondary|Change in Mean Plasma Glucose (PG) of 7-Point Profile From Baseline to Week 36|Estimated mean change from baseline in mean PG of 7-point profile (7-points were before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner and at bedtime) after 36 Weeks of treatment.|Week 0, Week 36|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial products. Missing data were imputed using last observation carried forward (LOCF). 8 subjects did not contribute to the statistical analysis at Week 36 due to missing data.||mmol/L||Standard Error|Mean
680160|NCT01572740|Secondary|Change in Mean Plasma Glucose (PG) of 7-Point Profile From Baseline to Week 16|Estimated mean change from baseline in mean PG of 7-point profile (7-points were before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner and at bedtime) after 16 Weeks of treatment.|Week 0, Week 16|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial products. Missing data were imputed using last observation carried forward (LOCF). 9 subjects did not contribute to the statistical analysis at Week 16 due to missing data.||mmol/L||Standard Error|Mean
680209|NCT01571453|Secondary|MADRS Response at Week 8 (Response Defined as a ≥50% Decrease in the MADRS Total Score From Baseline)||Week 8|The full-analysis set (FAS) comprises all patients in the APTS who had a valid baseline assessment and at least one valid post-baseline assessment of the MADRS total score.||percentage of patients|||Number
680163|NCT01572740|Secondary|Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 36|Estimated mean change from baseline in HbA1c after 36 Weeks of treatment|Week 0, Week 36|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial products. Missing data were imputed using last observation carried forward (LOCF). 1 subject in the placebo group did not contribute to the statistical analysis at Week 36 as subject was withdrawn from the trial before sampling for any efficacy data.||percentage of glycosylated haemoglobin||Standard Error|Mean
680164|NCT01572740|Primary|Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 16|Estimated mean change from baseline in HbA1c after 16 Weeks of treatment.|Week 0, Week 16|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial products. Missing data were imputed using last observation carried forward (LOCF). 1 subject in the placebo group did not contribute to the statistical analysis at Week 16 as subject was withdrawn from the trial before sampling for any efficacy data.||percentage of glycosylated haemoglobin||Standard Error|Mean
680165|NCT01572727|Secondary|Time to Definitive Deterioration of ECOG Performance Status (Phase Lll)|Time to definitive deterioration of the ECOG performance status from baseline|every 4 weeks|PFS, ORR and CBR were analyzed and reported at the interim analysis. Given the study met the futility analysis per protocol, the time to definitive deterioration of ECOG performance status was removed as a secondary endpoint in the final analysis and consequently not analyzed.|||||
680166|NCT01572727|Secondary|Plasma Concentration-time Profiles of BKM120 - Pharmacokinetics (PK) (Phase Lll)|Summary statistics for PK: plasma concentration-time profiles of BKM120 and appropriate individual PK parameters based on population PK model , if deemed appropriate; each cycle = 28 days|Cycle 1 day 1, 15, 16, 22 and Cycle 2 day 1.|PFS, ORR and CBR were analyzed and reported at the interim analysis. Given the study met the futility analysis per protocol, the plasma concentration-time profiles was removed as a secondary endpoint in the final analysis and consequently not analyzed.|||||
680167|NCT01572727|Secondary|Clinical Benefit Rate (CBR) (Phase ll)|CBR was defined as the percentage of patients with an overall response of CR or PR or SD or non-CR/non-PD lasting more than 24 weeks based on local Investigator’s assessment according to RECIST v1.1.|every 8 weeks after randomization Up to 3 months after end of Treatment|FAS per Expert Report: All pts randomized to study treatment. Per ITT principle, pts were analyzed according to treatment & strata. FAS was primary population for analysis of efficacy endpoints at interim. 338 pts were randomized (between 16-Aug-2012 & 07-Jun-2014) in 1:1 ratio to buparlisib + paclitaxel arm N=168 or placebo + paclitaxel arm N=170.||Percentage of participants||95% Confidence Interval|Number
680168|NCT01572727|Secondary|Time to Response (Phase Lll)|time from date of randomization until first documented response (CR or PR, which has to be confirmed subsequently).|every 8 weeks after randomization Up to 3 months after end of Treatment|PFS, ORR and CBR were analyzed and reported at the interim analysis. Given the study met the futility analysis per protocol, time to response was removed as a secondary endpoint in the final analysis and consequently not analyzed.|||||
680169|NCT01572727|Secondary|Duration of Response (Phase Lll)|time from the date of the first documented response (CR or PR, which had to be confirmed subsequently) to the date of the first radiologically documented disease progression or death due to disease|every 8 weeks after randomization Up to 3 months after end of Treatment|PFS, ORR and CBR were analyzed and reported at the interim analysis. Given the study met the futility analysis per protocol, the duration of response was removed as a secondary endpoint in the final analysis and consequently not analyzed.|||||
680170|NCT01572727|Secondary|Overall Response Rate (Phase ll)|Percentage of patients with best overall response of complete response (CR) or partial response (PR) based on local investigator's assessment according to RECIST v1.1. According to this criteria, CR = at least two determinations of CR at least 4 weeks apart before progression; PR = at least two determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|every 8 weeks after randomization Up to 3 months after end of Treatment|FAS per Expert Report: All pts randomized to study treatment. Per ITT principle, pts were analyzed according to treatment & strata. FAS was primary population for analysis of efficacy endpoints at interim. 338 pts were randomized (between 16-Aug-2012 & 07-Jun-2014) in 1:1 ratio to buparlisib + paclitaxel arm N=168 or placebo + paclitaxel arm N=170.||Percentage of participants||95% Confidence Interval|Number
680171|NCT01572727|Secondary|Overall Survival by Kaplan-Meier Estimate (Phase ll)|Overall survival (OS) was defined as the time from date of randomization to date of death due to any cause. If a patient was not known to have died by the date of analysis cut-off, OS was censored at the date of last contact.|every 3 months until death, lost to follow-up, or withdrawal of consent to survival follow-up, up to 10 months after futility was analyzed|Full analysis set (FAS) comprises all patients who were randomized to study treatment.||Months||95% Confidence Interval|Median
680172|NCT01572727|Primary|Progression-free Survival (PFS)Assessed by Local Investigator’s Assessment (Phase ll)|PFS was defined as the time from the date of randomization to the date of the event, defined as the first radiologically documented disease progression or death due to any cause. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Every 8 weeks from randomization until disease progression up to 10 months after futility was analyzed|FAS per Expert Report: All pts randomized to study treatment. Per ITT principle, pts were analyzed according to treatment & strata. FAS was primary population for analysis of efficacy endpoints at interim. 338 pts were randomized (between 16-Aug-2012 & 07-Jun-2014) in 1:1 ratio to buparlisib + paclitaxel arm N=168 or placebo + paclitaxel arm N=170.||Months||95% Confidence Interval|Median
680173|NCT01572675|Secondary|Number of Participants Who Discontinued Study Drug Due to an Adverse Event|Discontinuation/withdrawal of study treatment due to an adverse event was performed at the discretion of the investigator or the Sponsor for safety concerns. An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.|Up to 12 months|The safety population consisting of all participants who enrolled in the study||Participants|||Number
680175|NCT01572675|Secondary|Number of Participants With Contraindications for Use of Arcoxia®|Participants noted with contraindications for use of Arcoxia® according to the MA during initiation of treatment are described. CHF = congestive heart failure. HA = hepatic impairment. IBD = inflammatory bowel disease. IHD = ischemic heart disease. PAD = peripheral artery disease.|At study entry|The safety population consisting of all participants who enrolled in the study with data of sufficient quality for analysis of the endpoint (contraindications)||Participants|||Number
680176|NCT01572675|Secondary|Number of Participants Switching to Another Treatment With the Same Reason for Prescription|Participants who switched to another NSAID or other therapy for the same reason for prescription upon discontinuation of treatment with Arcoxia® or Celebrex® were determined.|Up to 12 months|All participants who discontinued treatment during follow-up under protocol; participants who were lost to follow-up were excluded from this analysis.||Participants|||Number
680177|NCT01572675|Secondary|Number of Participants Treated With Other Agents Prior to Initiation of Arcoxia® and Celebrex®|Other prescribed agents for the same study indication within 3 months preceding the decision to initiate treatment with selective COX-2 inhibitors (Arcoxia® or Celebrex®) were determined using the participant's medical record. NSAIDS = Non-steroidal inflammatory agents.|Up to 3 months prior to study entry|The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (other prior agents)||Participants|||Number
680178|NCT01572675|Secondary|Medications Co-Prescribed Over the Course of Follow-up With Arcoxia® and Celebrex®|Concomitant medications prescribed during the course of follow-up to participants treated with Arcoxia® and Celebrex® were extracted from participants' medical records. NSAIDS = Non-steroidal anti-inflammatory agents.|Up to 12 months|All participants in compliance with study inclusion criteria with at least one follow-up visit (with an available prescription file) other than the end-of-study visit were used for analysis of the endpoint||Participants|||Number
680179|NCT01572675|Secondary|Medications Co-Prescribed at Study Entry in Participants Treated With Arcoxia® and Celebrex®|Concomitant medications prescribed to participants treated with Arcoxia® and Celebrex® were collected via the physician prescription note at time of participant's study entry. NSAIDS = Non-steroidal anti-inflammatory agents.|At study entry|The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (co-prescriptions at entry)||Participants|||Number
680180|NCT01572675|Secondary|Significant Past Treatments Prior to Initiating Treatment With Arcoxia® or Celebrex®|'Significant' treatments that preceded the use of selective COX-2 inhibitors (Arcoxia® or Celebrex®) were identified using a closed-ended (yes/ no/ do not know) questionnaire. Significant is defined as associated with a chronic disease or having a potential link with participant's current use of a selective COX-2 inhibitors (Arcoxia® or Celebrex®). ARBs = Angiotensin 2 receptor blockers. ACEIs = Angiotensin-converting enzyme inhibitors. SSRIs = Selective serotonin reuptake Inhibitors. PAIs = Platelet aggregation inhibitors.|At study entry|The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (past treatments)||Participants|||Number
680181|NCT01572675|Secondary|Co-morbidities in Participants Treated With Arcoxia® and Celebrex®|Associated co-morbidities at study entry (baseline) in participants treated with Arcoxia® or Celebrex® were recorded by the Investigating Physician. CHF/IHD/PAD = Congestive heart failure/Ischemic heart disease/Peripheral artery disease|At study entry|The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (co-morbidities)||Participants|||Number
680182|NCT01572675|Secondary|Medical History of Participants Treated With Arcoxia® and Celebrex®|Relevant medical history of participants treated with Arcoxia® or Celebrex® was recorded by the Investigating Physician.|At study entry|The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (medical history)||Participants|||Number
680183|NCT01572675|Secondary|Blood Pressure at Study Entry in Participants Treated With Arcoxia® and Celebrex®|Participants' BP (SBP/DBP) was assessed at study entry by the Investigating Physician. Definition of controlled BP: SBP <140 mmHg and DBP <90 mmHg. Definition of uncontrolled BP: SBP ≥140 mmHg and/or DBP ≥90 mmHg.|At study entry (baseline)|The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (BP)||Participants|||Number
680184|NCT01572675|Secondary|Mean Systolic and Diastolic Blood Pressure (BP) at Study Entry in Participants Treated With Arcoxia® and Celebrex®|Mean systolic blood pressure (SBP) and diastolic blood pressure (DBP) were assessed at study entry by the Investigating Physician. Definition of controlled BP: SBP <140 mmHg and DBP <90 mmHg. Definition of uncontrolled BP: SBP ≥140 mmHg and/or DBP ≥90 mmHg.|At study entry (baseline)|The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (SBP and DBP)||mmHG||Standard Deviation|Mean
680185|NCT01572675|Secondary|Mean Body Mass Index (BMI) at Study Entry in Participants Treated With Arcoxia® and Celebrex®|Participants' BMI was assessed at study entry by the Investigating Physician. BMI is calculated as the participant's weight in kilograms (kg) divided by height in meters squared. BMI under 18.5 is commonly considered underweight; within the range (18.5 to 25) as normal weight; within the range (25 to 30) as overweight; and over 30 as obese.|At study entry (baseline)|The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (BMI)||kg/m^2||Standard Deviation|Mean
680186|NCT01572675|Primary|Type of Arcoxia® and Celebrex® Use According to Duration of Treatment|Use of selective cyclooxygenase-2 (COX-2) inhibitors (Arcoxia® and Celebrex®) as assessed by the Investigating Physician at time of treatment discontinuation was correlated to the overall duration of treatment experienced by the participant (i.e., intermittent or continuous selective COX-2 inhibitor use vs. total participant time on treatment). Type of use was classified as continuous (without interruption >7 days) or intermittent (with interruption >7 days). Four successive treatment intervals were assessed in this endpoint: 1) Up to thirty days of treatment 2) From one to three months of treatment 3) From three months to one year of treatment and 4) More than one year of treatment.|Up to 12 months|All participants who discontinued treatment during follow-up under protocol; participants who were lost to follow-up were excluded from this analysis.||Participants|||Number
680188|NCT01572675|Primary|Reasons for Discontinuation of Treatment With Arcoxia® and Celebrex®|The individual reasons for discontinuation of treatment with Arcoxia® or Celebrex® were identified over the course of study through either physician selection from a pre-determined list or verbatim entry by the physician with subsequent re-codification by Sponsor.|Up to 12 months|All participants who discontinued treatment during follow-up under protocol; participants who were lost to follow-up were excluded from this analysis.||Participants|||Number
680189|NCT01572675|Primary|Maximum Dosage Prescribed During Treatment With Arcoxia® and Celebrex®|Mean maximum dosage prescribed during follow-up in participants treated with Arcoxia® or Celebrex®. Dosage is expressed as total daily dose.|Up to 12 months|All participants who discontinued treatment during follow-up or were still on treatment after one year of follow-up under protocol; participants who were lost to follow-up were excluded from this analysis.||mg/day||Standard Deviation|Mean
680190|NCT01572675|Primary|Total Duration of Treatment With Arcoxia® and Celebrex®|The total duration of treatment (DoT) with Arcoxia® or Celebrex® was determined for populations that achieved end-of study and end-of-protocol or that were categorized as lost to follow-up. Participants enumerated as end-of-study had their treatment discontinued during the protocol-specified one year of follow-up. Participants enumerated as end-of-protocol were ongoing treatment at end of the protocol-specified one year of follow-up. Participants categorized as lost to follow-up had no follow-up visit where a determination of discontinuation from treatment could be made.|Up to 12 months|The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (duration of prescription)||Days||Standard Deviation|Mean
680191|NCT01572675|Primary|Duration of Prescription for Arcoxia® and Celebrex® at Enrollment|The mean duration of prescription at enrollment for participants treated with Arcoxia® and Celebrex® was determined using the participant's record.|Up to 3 months prior to study entry|The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (duration of prescription)||Days||Standard Deviation|Mean
680192|NCT01572675|Primary|Number of Participants Requiring Dose Modification of Arcoxia® and Celebrex®|Participants requiring modifications to their Arcoxia® or Celebrex® dose regimens during their on study treatment course were identified. Dose modifications were defined as an increase, decrease followed by increase, decrease, or increase followed by decrease in the participant's daily dose; all categorizations were exclusive. If the maximum dose at discontinuation of treatment was greater than that at initiation, the participant was considered as having had an increase in dose during treatment. Alternatively, if data obtained from a participant's prescription records showed a successive lowering of dosage, the participant was considered as having had a decrease in dose during treatment. Dosages at baseline were included in the dose modification determination for treatment renewal participants.|Up to 12 months|All participants who discontinued treatment during follow-up or were still on treatment after one year of follow-up under protocol; participants who were lost to follow-up were excluded from this analysis.||Participants|||Number
680193|NCT01572675|Primary|Mean Dosage of Arcoxia® and Celebrex® During Treatment|The mean dosage of Arcoxia® and Celebrex® during treatment was determined. For participants who stopped treatment after their initial study visit, the maximum dose recorded at their final study visit was considered when calculating their mean dosage during treatment.|Up to 12 months|All participants who discontinued treatment during follow-up or were still on treatment after one year of follow-up under protocol; participants who were lost to follow-up were excluded from this analysis.||mg/day||Standard Deviation|Mean
680194|NCT01572675|Primary|Dosage of Arcoxia® and Celebrex® at Initiation|Dosage at initiation of treatment with Arcoxia® or Celebrex® was identified. MA compliant dosage at initiation corresponds to a (starting) dose of 30 mg daily for Arcoxia® or a (starting) dose of 200 mg daily for Celebrex®. The dose for initiation was calculated by multiplying the number of doses per day with the dose level (total daily dose) as noted in the prescription record.|At study entry|The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (dosage at initiation)||Participants|||Number
680195|NCT01572675|Primary|Indications for Which Arcoxia® and Celebrex® Were Prescribed|The reasons (indications) for prescribing of Arcoxia® or Celebrex® were collected in open-field forms by the Investigator; category assignment (i.e, re-codification) of verbatim entries was conducted by a group of medical experts under the guidance approved by the MA. This endpoint gives the number of participants treated per indication.|At study entry|The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (indication)||Participants|||Number
680196|NCT01572675|Primary|Reasons for Misuse of Arcoxia® and Celebrex®|Proper use of study medication is defined as administration of medication in terms of indication and dosage according to MA. Proper use of Arcoxia® is defined as administration of a starting dose of 30 mg daily, not to exceed 60 mg daily during follow-up, for the treatment of symptoms of osteoarthritis. Proper use of Celebrex® is defined as administration of a starting dose of 200 mg daily, not to exceed 400 mg daily during follow-up, for easing symptoms in the treatment of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. Data to assess proper use were collected through use of a medical questionnaire and patient form. Data pertaining to indication was collected by open-field to allow physicians to precisely indicate the reason for prescription. Recorded indications were then analyzed by two medical experts (an independent expert and a member of the Scientific Community) to assess proper use or misuse.|Up to 12 months|The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (misuse)||Participants|||Number
680210|NCT01571453|Secondary|Change in HAM-A Total Score From Baseline to Week 8|Hamilton Anxiety Rating Scale (HAM-A) is a 14-item rating scale designed to assess the global anxiety. Each symptom is rated from 0 (absent) to 4 (maximum severity). The total score of the 14 items ranges from 0 to 56. Higher score indicates greater anxiety, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Baseline and Week 8|The full-analysis set (FAS) comprises all patients in the APTS who had a valid baseline assessment and at least one valid post-baseline assessment of the MADRS total score.||units on a scale||Standard Error|Mean
680197|NCT01572675|Primary|Number of Participants Demonstrating Proper Use of Arcoxia® and Celebrex®|Proper use of study medication is defined as administration of medication in terms of indication and dosage according to Market Authorization (MA). Proper use of Arcoxia® is defined as administration of a starting dose of 30 mg daily, not to exceed 60 mg daily during follow-up, for the treatment of symptoms of osteoarthritis. Proper use of Celebrex® is defined as administration of a starting dose of 200 mg daily, not to exceed 400 mg daily during follow-up, for easing symptoms in the treatment of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. Data to assess proper use were collected through use of a medical questionnaire and patient form. Data pertaining to indication was collected by open-field to allow physicians to precisely indicate the reason for prescription. Recorded indications were then analyzed by two medical experts (an independent expert and a member of the Scientific Community) to assess proper use or misuse.|Up to 12 months|All participants with complete data relative to correct use of the coxib and at least 1 data point relative to misuse of the coxib.||Participants|||Number
680200|NCT01572207|Secondary|Changes From Baseline in Quality of Life|The Multiple Sclerosis Impact Scale will be administered. The total score is a sum of individual question scores, ranging from 29 (best possible outcome) to 145 (worst possible outcome). Therefore, the lower the number, the better the outcome.|Each patient will be given the assessment at 3 points during the study, at baseline, interim test (an average of 12 weeks from baseline) and at posttest (an average of 24 weeks from baseline).|||scores on a scale||Full Range|Mean
680201|NCT01572207|Secondary|Changes From Baseline in Physical Fitness|The physical assessment will include measuring the 6-minute walk test. The units reported are in meters for distance traveled by each participant during the six minutes. For this scale, the higher number is the better score as it is a direct measure of distance traveled.|Each patient will be given the assessment at 3 points during the study, at baseline, interim test (an average of 12 weeks from baseline) and at posttest (an average of 24 weeks from baseline).|||meters||Full Range|Mean
680202|NCT01572207|Primary|Changes From Baseline in Physical Activity Behavior|"Physical activity behavior will be measured with the Godin Leisure-Time Exercise Questionnaire. The Godin Leisure-Time Exercise Questionnaire calculates total weekly leisure activity by summing the products of separate intensities. Weekly leisure activity score = (9 x time/week) + (5 x times/week) + (3 x times/week) for strenuous, moderate and light activities, respectively. The scale is summed to equal the Total Units Mean.
With this scale, higher numbers are considered to be the better outcome as it indicates more physical activity."|Each subject will be given the questionnaire at 3 points during the study, at baseline, interim test (an average of 12 weeks from baseline) and at posttest (an average of 24 weeks from baseline).|||scores on a scale||Full Range|Mean
680203|NCT01571557|Secondary|Mean Change From Baseline in Central Retinal Thickness|Retinal thickness is assessed by optical coherence tomography (OCT) in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative mean change from baseline indicates an improvement and a positive mean change from baseline indicates a worsening.|Baseline, Week 24|All enrolled patients with complete data at this time point||micrometers (μm)||Standard Deviation|Mean
680204|NCT01571557|Secondary|Percentage of Patients With an Increase of ≥3 Lines From Baseline BCVA in the Study Eye|BCVA is measured in the study eye following each injection of OZURDEX® using the Snellen eye chart. BCVA measurements expressed in Snellen fractions are converted to logMAR units and the approximate ETDRS letter score is based on the formula: approximate ETDRS letters=85+50 x log10 (Snellen fraction). The converted scores are “approximate ETDRS letters” to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. One line on the EDTRS equals 5 ETDRS points. The lower the number of letters read correctly on the eye chart (lower number on the decimal scale) the worse the vision (or visual acuity). An increase of 3 letters or more indicates an improvement in BCVA.|Baseline, 48 Weeks|All enrolled patients||Percentage of Patients|||Number
680205|NCT01571557|Secondary|Percentage of Patients With an Increase of ≥2 Lines From Baseline BCVA in the Study Eye|BCVA is measured in the study eye following each injection of OZURDEX® using the Snellen eye chart. BCVA measurements expressed in Snellen fractions are converted to logMAR units and the approximate ETDRS letter score is based on the formula: approximate ETDRS letters=85+50 x log10 (Snellen fraction). The converted scores are “approximate ETDRS letters” to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. One line on the EDTRS equals 5 ETDRS points. The lower the number of letters read correctly on the eye chart (lower number on the decimal scale) the worse the vision (or visual acuity). An increase of 2 letters or more indicates an improvement in BCVA.|Baseline, 48 Weeks|All enrolled patients||Percentage of Patients|||Number
680206|NCT01571557|Primary|Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA is measured in the study eye following each injection of OZURDEX® using the Snellen eye chart. BCVA measurements expressed in Snellen fractions are converted to logMAR units and the approximate Early Treatment Diabetic Retinopathy Study (ETDRS) letter score is based on the formula: approximate ETDRS letters=85+50 x log10 (Snellen fraction). The converted scores are “approximate ETDRS letters” to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. One line on the EDTRS equals 5 ETDRS points. The lower the number of letters read correctly on the eye chart (lower number on the decimal scale) the worse the vision (or visual acuity). The higher the number of letters read correctly (higher number on the decimal scale), the better the vision (or visual acuity). A positive number change from baseline in the number of letters read means vision has improved and a negative number change from baseline means vision has worsened.|Baseline, Week 12|All enrolled patients with complete data at this time point||Approximate EDTRS Letters||Standard Deviation|Mean
680207|NCT01571453|Secondary|Number of Adverse Events||Baseline to Week 12||||||
680208|NCT01571453|Secondary|Remission at Week 8 (Remission Defined as a MADRS Total Score ≤10)||Week 8|The full-analysis set (FAS) comprises all patients in the APTS who had a valid baseline assessment and at least one valid post-baseline assessment of the MADRS total score.||percentage of patients|||Number
680745|NCT01565889|Other Pre-specified|Part B: On-treatment HIV RNA|Data for this outcome measure were collected for participants in Part B only.|Up to 8 weeks|Part B Safety Analysis Set: participants enrolled in Part B and received at least one dose of study drug(s).||copies/mL||Standard Deviation|Mean
680211|NCT01571453|Secondary|CGI-I Score at Week 8|The Clinical Global Impression - Global Improvement (CGI-I) provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). In all cases, the assessment should be made independent of whether the rater believes the improvement is drug-related or not. Higher score = more affected.|Week 8|The full-analysis set (FAS) comprises all patients in the APTS who had a valid baseline assessment and at least one valid post-baseline assessment of the MADRS total score.||units on a scale||Standard Error|Mean
680212|NCT01571453|Secondary|Change in CGI-S Score From Baseline to Week 8|Clinical Global Impression Scale - Severity of Illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients). Higher score indicates that the subject is more ill, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Baseline and Week 8|The full-analysis set (FAS) comprises all patients in the APTS who had a valid baseline assessment and at least one valid post-baseline assessment of the MADRS total score.||units on a scale||Standard Error|Mean
680213|NCT01571453|Primary|Change From Baseline in MADRS Total Score at Week 8|Montgomery and Asberg Depression Rating Scale (MADRS) is a ten-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at two-point intervals. The total score of the ten items ranges from 0 to 60. The higher the score, the more severe, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Baseline and Week 8|The full-analysis set (FAS) comprises all patients in the APTS who had a valid baseline assessment and at least one valid post-baseline assessment of the MADRS total score.||units on a scale||Standard Error|Mean
680214|NCT01571362|Secondary|Naltrexone and 6-β-naltrexol Observed Steady-State Plasma Concentration During the Double Blind Treatment Period|Observed steady-state plasma concentration (Cobs) of naltrexone and 6-β-naltrexol|Blood samples were taken within +/-4 hours of the morning dose of study drug at Randomization Baseline, Weeks 4, 8, and 12|Double-Blind Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.||pg/mL||Standard Deviation|Mean
680215|NCT01571362|Secondary|Oxycodone and Noroxycodone Observed Steady-State Plasma Concentration During the Double-Blind Treatment Period|Observed steady-state plasma concentration (Cobs) of oxycodone and noroxycodone|Blood samples were taken within +/-4 hours of the morning dose of study drug at Randomization Baseline, Weeks 4, 8, and 12|Double-Blind Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.||ng/mL||Standard Deviation|Mean
680216|NCT01571362|Secondary|Naltrexone and 6-β-naltrexol Observed Steady-State Plasma Concentration During the Titration Period|Cobs of naltrexone and 6-β-naltrexol|Blood samples were taken within +/-4 hours of the morning dose of ALO-02 at Week 6/Early Termination, Randomization Baseline|Titration Period Safety Population; participants assessed at Week 6 had not been randomized to the Double-Blind Period; participants assessed at Randomization Baseline had been randomized to the Double-Blind Period.||pg/mL||Standard Deviation|Mean
680217|NCT01571362|Secondary|Oxycodone and Noroxycodone Observed Steady-State Plasma Concentration During the Titration Period|Observed steady-state plasma concentration (Cobs) of oxycodone and noroxycodone.|Blood samples were taken within +/-4 hours of the morning dose of ALO-02 at Week 6/Early Termination, Randomization Baseline|Titration Period Safety Population; participants assessed at Week 6 had not been randomized to the Double-Blind Period; participants assessed at Randomization Baseline had been randomized to the Double-Blind Period.||ng/mL||Standard Deviation|Mean
680218|NCT01571362|Secondary|Median Oxycodone Duration of Treatment During the Double-Blind Treatment Period||Double-Blind Period|Double-Blind Safety Population||days||Inter-Quartile Range|Median
680219|NCT01571362|Secondary|Median Oxycodone Average Daily Dose During the Double-Blind Treatment Period||Double-Blind Period|Double-Blind Safety Population||mg||Inter-Quartile Range|Median
680220|NCT01571362|Secondary|Mean Oxycodone Duration of Treatment During the Double-Blind Treatment Period||Double-Blind Period|Double-Blind Safety Population||days||Standard Deviation|Mean
680221|NCT01571362|Secondary|Mean Oxycodone Average Daily Dose During the Double-Blind Treatment Period||Double-Blind Period|Double-Blind Safety Population||mg||Standard Deviation|Mean
680222|NCT01571362|Secondary|Median Oxycodone Duration of Titration During the Open-Label Titration Period||Open-Label Period|Titration Period Safety Population||days||Inter-Quartile Range|Median
680223|NCT01571362|Secondary|Median Oxycodone Average Daily Dose During the Open-Label Titration Period||Open-Label Period|Titration Period Safety Population||mg||Inter-Quartile Range|Median
680224|NCT01571362|Secondary|Mean Oxycodone Duration of Titration During the Open-Label Titration Period||Open-Label Period|Titration Period Safety Population||days||Standard Deviation|Mean
680225|NCT01571362|Secondary|Mean Oxycodone Average Daily Dose During the Open-Label Titration Period||Open-Label Period|Titration Period Safety Population||mg||Standard Deviation|Mean
680226|NCT01571362|Secondary|Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights in Hospital for Chronic Low Back Pain|Question 3b: nights stayed in the hospital|Screening, Weeks 4, 8, and 12|ITT Population; imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint.||Number of nights||Standard Deviation|Mean
680227|NCT01571362|Secondary|Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatment for Chronic Low Back Pain|Question 2: money (dollars) spent out-of-pocket on physical treatments in the past 4 weeks to manage chronic low back pain|Screening, Weeks 4, 8, and 12|ITT Population; imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint.||Dollars||Standard Deviation|Mean
680228|NCT01571362|Secondary|Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Number of Office Visits Related or Medication Used for Chronic Low Back Pain|Question 1: number of office visits directly related to chronic low back pain or any medication used for chronic low back pain|Screening, Weeks 4, 8, and 12|ITT Population; imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint.||Number of visits||Standard Deviation|Mean
680229|NCT01571362|Secondary|Percentage of Participants With Shift From Screening Period to the End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire|Question 3a = In the past 4 weeks, have you been hospitalized due to chronic low back pain or any medication used for chronic low back pain?|Screening, Weeks 4, 8, and 12|ITT Population; the denominator for the percentage calculation is the number of participants who had both Screening value and Post Screening value for each treatment and visit. Imputation using the LOCF method.||Percentage of participants|||Number
680230|NCT01571362|Secondary|Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights Spent in Hospital|Question 3b: nights stayed in the hospital|Randomization Baseline, Weeks 4, 8, and 12|ITT Population; imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint.||Number of nights||Standard Deviation|Mean
680231|NCT01571362|Secondary|Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatments|Question 2: money (dollars) spent out-of-pocket on physical treatments in the past 4 weeks to manage chronic low back pain.|Randomization Baseline, Weeks 4, 8, and 12|ITT Population, imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint.||Dollars||Standard Deviation|Mean
680232|NCT01571362|Secondary|Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Number of Office Visits Related to or Medications Used for Chronic Low Back Pain|Question 1: number of office visits directly related to chronic low back pain or any medication used for chronic low back pain|Randomization Baseline, Weeks 4, 8, and 12|ITT Population; imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint.||Number of visits||Standard Deviation|Mean
680233|NCT01571362|Secondary|Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire|Question 3a = In the past 4 weeks, have you been hospitalized due to chronic low back pain or any medication used for chronic low back pain?|Randomization Baseline, Weeks 4, 8, and 12 (or Early Termination)|ITT Population; the denominator for the percentage calculation is the number of participants who had both Randomization Baseline value and Post Randomization value for each treatment and visit. Imputation using the LOCF method.||Percentage of participants|||Number
680234|NCT01571362|Secondary|Change From Screening to End of Open-Label Titration Period in HRU Questionnaire: Nights Stayed in Hospital|Question 3b: nights stayed in the hospital, if answer to Q3a was yes.|Screening, Week 6 (or Early Termination)|Titration Period Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.||Number of days||Standard Deviation|Mean
680235|NCT01571362|Secondary|Change From Screening to End of Open-Label Titration Period in HRU Questionnaire: Money Spent on Physical Treatments in Past 4 Weeks|Question 2: Money (dollars) spent out-of-pocket on physical treatments in the past 4 weeks to manage chronic low back pain|Screening, Week 6 (or Early Termination)|Titration Period Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.||Dollars||Standard Deviation|Mean
680236|NCT01571362|Secondary|Change From Screening to End of Open-Label Titration Period in HRU Questionnaire: Number of Office Visits Directly Related or Any Medication Used for Chronic Low Back Pain|Question 1: number of office visits directly related to chronic low back pain or any medication used for chronic low back pain.|Screening, Week 6 (or Early Termination)|Titration Period Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.||Number of visits||Standard Deviation|Mean
680237|NCT01571362|Secondary|Change From Screening to Randomization Baseline in HRU Questionnaire: Nights Stayed in Hospital|Question 3b: nights stayed in the hospital, if answer to Q3a was yes.|Screening, Randomization Baseline|ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint.||Number of days||Standard Deviation|Mean
680238|NCT01571362|Secondary|Change From Screening to Randomization Baseline in HRU Questionnaire: Money Spent on Physical Treatments in Past 4 Weeks|Question 2: Money (dollars) spent out-of-pocket on physical treatments in the past 4 weeks to manage chronic low back pain|Screening, Randomization Baseline|ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint.||Dollars||Standard Deviation|Mean
680239|NCT01571362|Secondary|Change From Screening to Randomization Baseline in HRU Questionnaire: Number of Office Visits Directly Related or Any Medication Used for Chronic Low Back Pain|Question 1: number of office visits directly related to chronic low back pain or any medication used for chronic low back pain.|Screening, Randomization Baseline|ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint.||Number of visits||Standard Deviation|Mean
680240|NCT01571362|Secondary|Percentage of Participants With Shift From Screening Period to Randomization Baseline in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire|Question 3a = In the past 4 weeks, have you been hospitalized due to chronic low back pain or any medication used for chronic low back pain?|Screening, Randomization Baseline|ITT Population; the denominator for the percentage calculation is the number of participants who had both Screening value and Randomization Baseline value.||Percentage of participants|||Number
680241|NCT01571362|Secondary|Percentage of Participants With Shift From Screening Period to End of Open-Label Titration Period in Hospitalization Because of Low Back Pain as Assessed Using the Healthcare Resource Use (HRU) Questionnaire|Question 3a = In the past 4 weeks, have you been hospitalized due to chronic low back pain or any medication used for chronic low back pain?|Screening, Week 6 (or Early Termination)|Titration Period Safety Population; the denominator for the percentage calculation is the number of participants who had both Screening value and End of Open-Label value.||Percentage of participants|||Number
680256|NCT01571362|Secondary|Change From Screening Period to Randomization Baseline in Participant Assessment of Overall Health State Using the EQ-5D VAS|The EQ-5D consists of a standard vertical 20cm visual analogue scale (EQ VAS), for recording a participant's rating for their current health related quality of life state; the scale went from 0 (worst imaginable health state) to 100 (best imaginable health state). Participants were asked to draw a line on the scale to indicate how good or bad your own health is today, in your opinion.|Screening, Randomization Baseline|ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint.||Score on a scale||Standard Deviation|Mean
680242|NCT01571362|Secondary|Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Activity Impairment Due to Low Back Pain|"A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment.
% activity impairment - a measure of the degree to which health problem has affected ability to do regular activities other than work at a job (question 6). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity."|Screening, Weeks 4, 8, and 12|ITT Population; imputation by the LOCF method was used for Week 12 (or Final Visit) only; Weeks 4 and 8 were based on observed cases. n=number of participants analyzed for the given parameter at the specified timepoint.||Percentage||Standard Error|Least Squares Mean
680243|NCT01571362|Secondary|Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Overall Work Impairment Due to Low Back Pain|"A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment.
% overall work impairment - a measure of overall work productivity loss due to health problem (absenteeism+presenteeism). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity."|Screening, Weeks 4, 8, and 12|ITT Population; imputation by the LOCF method was used for Week 12 (or Final Visit) only; Weeks 4 and 8 were based on observed cases. n=number of participants analyzed for the given parameter at the specified timepoint.||Percentage||Standard Error|Least Squares Mean
680244|NCT01571362|Secondary|Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Impairment Due to Low Back Pain|"A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment.
% impairment while working - a measure of presenteeism, the degree to which health problem impacted work (question 5). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity."|Screening, Weeks 4, 8, and 12|ITT Population; imputation by the LOCF method was used for Week 12 (or Final Visit) only; Weeks 4 and 8 were based on observed cases. n=number of participants analyzed for the given parameter at the specified timepoint.||Percentage||Standard Error|Least Squares Mean
680245|NCT01571362|Secondary|Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Work Time Missed Due to Low Back Pain|"A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment.
% work time missed - a measure of absenteeism, calculated as work time missed due to health problem (question 2) as a proportion of hours actually worked (question 4). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity."|Screening, Weeks 4, 8, and 12|ITT Population; imputation by the LOCF method was used for Week 12 (or Final Visit) only; Weeks 4 and 8 were based on observed cases. n=number of participants analyzed for the given parameter at the specified timepoint.||Percentage||Standard Error|Least Squares Mean
680246|NCT01571362|Secondary|Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Activity Impairment Due to Low Back Pain|"A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment.
% activity impairment - a measure of the degree to which health problem has affected ability to do regular activities other than work at a job (question 6). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity."|Randomization Baseline, Weeks 4, 8, and 12|ITT Population; imputation by the LOCF method was used for Week 12 (or Final Visit) only; Weeks 4 and 8 were based on observed cases. n=number of participants analyzed for the given parameter at the specified timepoint.||Percentage||Standard Error|Least Squares Mean
680247|NCT01571362|Secondary|Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Overall Work Impairment Due to Low Back Pain|"A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment.
% overall work impairment - a measure of overall work productivity loss due to health problem (absenteeism+presenteeism).
Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity."|Randomization Baseline, Weeks 4, 8, and 12|ITT Population; imputation by the LOCF method was used for Week 12 (or Final Visit) only; Weeks 4 and 8 were based on observed cases. n=number of participants analyzed for the given parameter at the specified timepoint.||Percentage||Standard Error|Least Squares Mean
680248|NCT01571362|Secondary|Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Impairment Due to Low Back Pain|"A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment.
% impairment while working - a measure of presenteeism, the degree to which health problem impacted work (question 5).
Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity."|Randomization Baseline, Weeks 4, 8, and 12|ITT Population; imputation by the LOCF method was used for Week 12 (or Final Visit) only; Weeks 4 and 8 were based on observed cases. n=number of participants analyzed for the given parameter at the specified timepoint.||Percentage||Standard Error|Least Squares Mean
680294|NCT01571362|Secondary|Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Interference Index|Pain Interference Index is the mean of the scores for the 7 items of the BPI-sf; range is 0=Does not interfere to 10=Completely interferes.|Weeks 2, 4, 8, and 12|ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for pain interference index at the specified timepoint.||Units on a Scale||Standard Error|Least Squares Mean
680249|NCT01571362|Secondary|Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Work Time Missed Due to Low Back Pain|"A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment.
% work time missed - a measure of absenteeism, calculated as work time missed due to health problem (question 2) as a proportion of hours actually worked (question 4).
Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity."|Randomization Baseline, Weeks 4, 8, and 12|ITT Population; imputation by the LOCF method was used for Week 12 (or Final Visit) only; Weeks 4 and 8 were based on observed cases. n=number of participants analyzed for the given parameter at the specified timepoint.||Percentage||Standard Error|Least Squares Mean
680250|NCT01571362|Secondary|Change From Screening Period to Randomization Baseline in WPAI:SHP: Percent Work Time Missed, Percent Impairment, Percent Overall Work Impairment, Percent Activity Impairment Due to Low Back Pain|"A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment.
work time missed - a measure of absenteeism, calculated as work time missed due to health problem (question 2) as a proportion of hours actually worked (question 4).
impairment while working - a measure of presenteeism, the degree to which health problem impacted work (question 5).
overall work impairment - a measure of overall work productivity loss due to health problem (absenteeism+presenteeism).
activity impairment - a measure of the degree to which health problem has affected ability to do regular activities other than work at a job (question 6).
Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity."|Screening, Randomization Baseline|ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint.||Percentage||Standard Deviation|Mean
680251|NCT01571362|Secondary|Change From Screening Period to End of Open-Label in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP): % Work Time Missed, % Impairment, % Overall Work Impairment, % Activity Impairment Due to Low Back Pain|"A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment /absenteeism+presenteeism); and activity impairment.
work time missed - a measure of absenteeism, calculated as work time missed due to health problem (question 2) as a proportion of hours actually worked (question 4).
impairment while working - a measure of presenteeism, the degree to which health problem impacted work (question 5).
overall work impairment - a measure of overall work productivity loss due to health problem (absenteeism+presenteeism).
activity impairment - a measure of the degree to which health problem has affected ability to do regular activities other than work at a job (question 6). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity."|Screening, Week 6 (or Early Termination)|Titration Period Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.||Percentage||Standard Deviation|Mean
680252|NCT01571362|Secondary|Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using EQ-5D VAS|The EQ-5D consists of a standard vertical 20cm visual analogue scale (EQ VAS), for recording a participant's rating for their current health related quality of life state; the scale went from 0 (worst imaginable health state) to 100 (best imaginable health state). Participants were asked to draw a line on the scale to indicate how good or bad your own health is today, in your opinion.|Screening, Week 12|ITT Population; imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint.||Score on a scale||Standard Error|Least Squares Mean
680253|NCT01571362|Secondary|Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using EQ-5D Summary Index|Self-completion standardized instrument for use as a measure of health-related quality of life in terms of a single index value or utility score that consisted of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which was rated on a 3-point response scale (no problems/some or moderate problems/extreme problems), and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health.|Screening, Week 12|ITT Population; imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint.||Score on a scale||Standard Error|Least Squares Mean
680254|NCT01571362|Secondary|Change From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using the EQ-5D VAS|The EQ-5D consists of a standard vertical 20cm visual analogue scale (EQ VAS), for recording a participant's rating for their current health related quality of life state; the scale went from 0 (worst imaginable health state) to 100 (best imaginable health state). Participants were asked to draw a line on the scale to indicate how good or bad your own health is today, in your opinion.|Randomization Baseline, Week 12|ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint.||Score on a scale||Standard Error|Least Squares Mean
680255|NCT01571362|Secondary|Change From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using EQ-5D Summary Index|Self-completion standardized instrument for use as a measure of health-related quality of life in terms of a single index value or utility score that consisted of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which was rated on a 3-point response scale (no problems/some or moderate problems/extreme problems), and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health|Randomization Baseline, Week 12|ITT Population; imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint.||Score on a scale||Standard Error|Least Squares Mean
680295|NCT01571362|Secondary|Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Severity Index|Pain Severity Index is the mean of the 4 pain scores (worst, least, average, and right now) on the BPI-sf; range is 0=No pain to 10=Pain as bad as you can imagine; a higher score indicates greater pain severity.|Weeks 2, 4, 8, and 12|ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for pain severity index at the specified timepoint.||Units on a Scale||Standard Error|Least Squares Mean
680257|NCT01571362|Secondary|Change From Screening Period to Randomization Baseline in Participant Assessment of Overall Health State Using the EQ-5D Summary Index|Self-completion standardized instrument for use as a measure of health-related quality of life in terms of a single index value or utility score that consisted of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which was rated on a 3-point response scale (no problems/some or moderate problems/extreme problems), and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health|Screening, Randomization Baseline|ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint.||Score on a scale||Standard Deviation|Mean
680258|NCT01571362|Secondary|Change From Screening Period to the End of Open-Label Titration Period in Participant Assessment of Overall Health State Using the EQ-5D VAS|The EQ-5D consists of a standard vertical 20cm visual analogue scale (EQ VAS), for recording a participant's rating for their current health related quality of life state; the scale went from 0 (worst imaginable health state) to 100 (best imaginable health state). Participants were asked to draw a line on the scale to indicate how good or bad your own health is today, in your opinion.|Screening, Week 6 (or Early Termination)|Titration Period Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.||Score on a scale||Standard Deviation|Mean
680259|NCT01571362|Secondary|Change From Screening Period to the End of Open-Label Titration Period in Participant Assessment of Overall Health State Using the EuroQol 5-Dimensions (EQ-5D) Summary Index|The EQ 5D Health Questionnaire is a self completion standardized instrument for use as a measure of health-related quality of life in terms of a single index value or utility score that consisted of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which was rated on a 3-point response scale (no problems/some or moderate problems/extreme problems), and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health.|Screening, Week 6 (or Early Termination)|Titration Period Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.||Score on a scale||Standard Deviation|Mean
680260|NCT01571362|Secondary|Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey|SF-36v2 Health Survey is a self-administered questionnaire consisting of 36 questions, measuring 8 health aspects; physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception. These domains also combine to form two component summary scores evaluating mental health and physical health. The minimum score is 0 and the maximum score is 100. A higher score indicate a better health state.|Screening, Week 12|ITT Population; imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint.||Score on a scale||Standard Error|Least Squares Mean
680261|NCT01571362|Secondary|Change From Randomization Baseline to the End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey|SF-36v2 Health Survey is a self-administered questionnaire consisting of 36 questions, measuring 8 health aspects; physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception. These domains also combine to form two component summary scores evaluating mental health and physical health. The minimum score is 0 and the maximum score is 100. A higher score indicate a better health state.|Randomization Baseline, Week 12|ITT Population; imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint.||Score on a scale||Standard Error|Least Squares Mean
680262|NCT01571362|Secondary|Change From Screening Period to Randomization Baseline in SF-36v2 Health Survey Score|SF-36v2 Health Survey is a self-administered questionnaire consisting of 36 questions, measuring 8 health aspects; physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception. These domains also combine to form two component summary scores evaluating mental health and physical health. The minimum score is 0 and the maximum score is 100. A higher score indicate a better health state.|Screening, Randomization Baseline|ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint.||Score on a scale||Standard Deviation|Mean
680263|NCT01571362|Secondary|Change From Screening Period to the End of Open-Label Titration Period in Short Form-36v2 (SF-36v2) Health Survey Score|SF-36v2 Health Survey is a self-administered questionnaire consisting of 36 questions, measuring 8 health aspects; physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception. These domains also combine to form two component summary scores evaluating mental health and physical health. The minimum score is 0 and the maximum score is 100. A higher scores indicates a better health state.|Screening, Week 6 (or Early Termination)|Titration Period Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.||Score on a scale||Standard Deviation|Mean
680264|NCT01571362|Secondary|Percentage of Participants Who Reported Being Satisfied/Very Satisfied With Treatment on the Satisfaction With Treatment Questionnaire During the Double-Blind Treatment Period|Participants used an electronic tablet at the center to rate their overall treatment satisfaction with study drug during study participation using a 5-point categorical scale (1 = very dissatisfied, 2 = dissatisfied, 3 = neither satisfied nor dissatisfied, 4 = satisfied, 5 = very satisfied).|Week 12 or Early Termination|ITT Population; percentage was based on the number of participants with non-missing response to treatment. n=number of participants analyzed for the given parameter at the specified timepoint.||Percentage of participants|||Number
680265|NCT01571362|Secondary|Satisfaction With Treatment at Randomization Baseline|Satisfaction with treatment is a single-item self-rated instrument that measures the participant's overall satisfaction with the study drug during study participation on a 5-point likert scale ranging from 1 = Very dissatisfied to 5 = Very satisfied.|Randomization Baseline|ITT Population; percentage was based on the number of participants with non-missing response to treatment. n=number of participants analyzed for the given parameter at the specified timepoint.||Percentage of participants|||Number
680266|NCT01571362|Secondary|Satisfaction With Treatment at the End of Open-Label Titration Period for All Participants|Satisfaction with treatment is a single-item self-rated instrument that measures the participant's overall satisfaction with the study drug during study participation on a 5-point likert scale ranging from 1 = Very dissatisfied to 5 = Very satisfied.|End of Open-Label Titration Period (Week 4, 5, or 6 or Early Termination)|Titration Period Safety Population; percentage was based on the number of participants with non-missing response to treatment. n=number of participants analyzed for the given parameter at the specified timepoint.||Percentage of participants|||Number
680267|NCT01571362|Secondary|Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor|Represents the score at Randomization Baseline / score at Week 8 in PGA of low back pain, a global evaluation that utilizes a 5-point Likert scale with a score of: 1 = very good, asymptomatic and no limitation of normal activities; 2 = good, mild symptoms, and no limitation of normal activities; 3 = fair, moderate symptoms and limitation to some normal activities; 4 = poor, severe symptoms and inability to carry out most normal activities; and a score of 5 = very poor; very severe symptoms, which were intolerable and inability to carry out all normal activities.|Randomization Baseline, Week 8|ITT Population; percentage was based on the number of participants who had non-missing values at Randomization Baseline and Week 8 for each treatment.||Percentage of participants|||Number
680268|NCT01571362|Secondary|Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor|Represents the score at Randomization Baseline / score at Week 4 in PGA of low back pain, a global evaluation that utilizes a 5-point Likert scale with a score of: 1 = very good, asymptomatic and no limitation of normal activities; 2 = good, mild symptoms, and no limitation of normal activities; 3 = fair, moderate symptoms and limitation to some normal activities; 4 = poor, severe symptoms and inability to carry out most normal activities; and a score of 5 = very poor; very severe symptoms, which were intolerable and inability to carry out all normal activities.|Randomization Baseline, Week 4|ITT Population; percentage was based on the number of participants who had non-missing values at Randomization Baseline and Week 4 for each treatment.||Percentage of participants|||Number
680269|NCT01571362|Secondary|Percentage of Participants With Shift From Screening to the End of the Open-Label Titration Period in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor|Represents the score at Screening / score at to end of the titration period in PGA of low back pain, a global evaluation that utilizes a 5-point Likert scale with a score of: 1 = very good, asymptomatic and no limitation of normal activities; 2 = good, mild symptoms, and no limitation of normal activities; 3 = fair, moderate symptoms and limitation to some normal activities; 4 = poor, severe symptoms and inability to carry out most normal activities; and a score of 5 = very poor; very severe symptoms, which were intolerable and inability to carry out all normal activities.|Screening, Randomization Baseline, or Early Termination|Titration Period Safety Population; percentage was based on the number of participants who had non-missing values at Randomization Baseline and Screening.||Percentage of participants|||Number
680270|NCT01571362|Secondary|Percentage of Participants With Shift From Screening to Randomization Baseline in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor|Represents the score at Screening / score at Randomization Baseline in PGA of low back pain, a global evaluation that utilizes a 5-point Likert scale with a score of: 1 = very good, asymptomatic and no limitation of normal activities; 2 = good, mild symptoms, and no limitation of normal activities; 3 = fair, moderate symptoms and limitation to some normal activities; 4 = poor, severe symptoms and inability to carry out most normal activities; and a score of 5 = very poor; very severe symptoms, which were intolerable and inability to carry out all normal activities.|Screening, Randomization Baseline|ITT Population; percentage was based on the number of participants who had non-missing values at Randomization Baseline and Screening.||Percentage of participants|||Number
680271|NCT01571362|Secondary|Change From Randomization Baseline to the End of Double-Blind Weeks 2, 4, and 8 in RMDQ Total Score|RMDQ is a 24-item questionnaire designed to measure self-rated disability due to back pain the same day the questionnaire is completed. An individual participant’s score could have ranged from 0 (no disability) to 24 (severe disability), with a lower score indicating better function.|Randomization Baseline, Weeks 2, 4, and 8|ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint.||Units on a scale||Standard Error|Least Squares Mean
680272|NCT01571362|Secondary|Change From Screening Period to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in RMDQ Total Score|RMDQ is a 24-item questionnaire designed to measure self-rated disability due to back pain the same day the questionnaire is completed. An individual participant’s score could have ranged from 0 (no disability) to 24 (severe disability), with a lower score indicating better function.|Screening, Weeks 2, 4, 8, and 12|ITT Population; imputation using the LOCF method for Week 12 only; Weeks 2, 4, 8 included observed cases. n=number of participants analyzed for the given parameter at the specified timepoint.||Units on a scale||Standard Error|Least Squares Mean
680273|NCT01571362|Secondary|Change From Screening Period to Randomization Baseline in RMDQ Total Score|RMDQ is a 24-item questionnaire designed to measure self-rated disability due to back pain the same day the questionnaire is completed. An individual participant’s score could have ranged from 0 (no disability) to 24 (severe disability), with a lower score indicating better function.|Screening, Randomization Baseline|ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint.||Units on a scale||Standard Deviation|Mean
680274|NCT01571362|Secondary|Change From Screening Period to End of Open-Label Titration Period in Roland-Morris Disability Questionnaire (RMDQ) Total Score for All Participants|RMDQ is a 24-item questionnaire designed to measure self-rated disability due to back pain the same day the questionnaire is completed. An individual participant’s score could have ranged from 0 (no disability) to 24 (severe disability), with a lower score indicating better function; higher scores indicating greater disability.|Screening, Week 6 (or Early Termination)|Titration Period Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.||Units on a scale||Standard Deviation|Mean
680746|NCT01565889|Other Pre-specified|Part B: On-treatment HCV RNA|Data for this outcome measure were collected for participants in Part B only.|Up to 8 weeks|Part B Full Analysis Set||log10 IU/mL||Standard Deviation|Mean
680275|NCT01571362|Secondary|SOWS Total Score During the Post-Treatment Period|The SOWS was completed daily by the participant during any of the 2-week tapers from study drug, as well as at each study visit, using an eDiary device, and contains 16 symptoms of opiate withdrawal rated by the participant (Scale of 0 to 4: 0 = not at all, 1 = a little, 2= moderately, 3= quite a bit, 4 = extremely). The sum of the scores on each item was the total SOWS score; the minimum possible SOWS score was 0, the maximum 64. Higher scores indicate a worse outcome.|Follow-Up Weeks 1 and 2|Double-Blind Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.||Units on a scale||Standard Deviation|Mean
680276|NCT01571362|Secondary|SOWS Total Score During the Double-Blind Treatment Period|The SOWS was completed daily by the participant during any of the 2-week tapers from study drug, as well as at each study visit, using an eDiary device, and contains 16 symptoms of opiate withdrawal rated by the participant (Scale of 0 to 4: 0 = not at all, 1 = a little, 2= moderately, 3= quite a bit, 4 = extremely). The sum of the scores on each item was the total SOWS score; the minimum possible SOWS score was 0, the maximum 64. Higher scores indicate a worse outcome.|Randomization Baseline, Weeks 1, 2, 4, 8, and 12|Double-Blind Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.||Units on a scale||Standard Deviation|Mean
680277|NCT01571362|Secondary|Subjective Opiate Withdrawal Scale (SOWS) During the Open-Label Titration Period|The SOWS was completed daily by the participant during any of the 2-week tapers from study drug, as well as at each study visit, using an eDiary device, and contains 16 symptoms of opiate withdrawal rated by the participant (Scale of 0 to 4: 0 = not at all, 1 = a little, 2= moderately, 3= quite a bit, 4 = extremely). The sum of the scores on each item was the total SOWS score; the minimum possible SOWS score was 0, the maximum 64. Higher scores indicate a worse outcome.|Screening, Weeks 1, 2, 3, 4, 5, and 6|Titration Period Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.||Units on a scale||Standard Deviation|Mean
680278|NCT01571362|Secondary|Percentage of Participants With Opiate Withdrawal During Post-Treatment by COWS Category|The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant’s signs or symptoms. The minimum total COWS score is 0, the maximum is 48. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal. The scores are assessed as follows: 5-12 = mild; 13-24 = moderate; 25-36 = moderately severe; more than 36 = severe withdrawal.|Follow-Up Weeks 1 and 2|Double-Blind Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.||Percentage of participants|||Number
680279|NCT01571362|Secondary|Percentage of Participants With Opiate Withdrawal During the Double-Blind Treatment Period by COWS Category|The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant’s signs or symptoms. The minimum total COWS score is 0, the maximum is 48. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal. The scores are assessed as follows: 5-12 = mild; 13-24 = moderate; 25-36 = moderately severe; more than 36 = severe withdrawal.|Randomization Baseline, Weeks 1, 2, 4, 8, 12 (or Early Termination)|Double-Blind Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.||Percentage of participants|||Number
680280|NCT01571362|Secondary|Percentage of Participants With Opiate Withdrawal During the Open-Label Titration Period by COWS Category|The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant’s signs or symptoms. The minimum total COWS score is 0, the maximum is 48. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal. The scores are assessed as follows: 5-12 = mild; 13-24 = moderate; 25-36 = moderately severe; more than 36 = severe withdrawal.|Screening, Weeks 1, 2, 3, 4, 5, 6 (or Early Termination)|Titration Period Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.||Percentage of participants|||Number
680281|NCT01571362|Secondary|COWS Total Score During the Post-Treatment Period|The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant’s signs or symptoms. The minimum total COWS score is 0, the maximum is 48. Higher scores indicate a worse outcome. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal.|Follow-Up (FU) Weeks 1 and 2|Double-Blind Safety Population. Only participants with values at both Randomization Baseline and each respective visit were included in the change from Randomization Baseline analysis; n=number of participants analyzed for the given parameter at the specified timepoint.||Units on a scale||Standard Deviation|Mean
680282|NCT01571362|Secondary|COWS Total Score During the Double-Blind Treatment Period|The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant’s signs or symptoms. The minimum total COWS score is 0, the maximum is 48. Higher scores indicate a worse outcome. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal.|Randomization Baseline, Weeks 1, 2, 4, 8, and 12|Double-Blind Safety Population. Only participants with values at both Randomization Baseline and each respective visit were included in the change from Randomization Baseline analysis; n=number of participants analyzed for the given parameter at the specified timepoint.||Units on a scale||Standard Deviation|Mean
680283|NCT01571362|Secondary|Clinical Opiate Withdrawal Scale (COWS) Total Score During the Open-Label Titration Period|The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant’s signs or symptoms. The minimum total COWS score is 0, the maximum is 48. Higher scores indicate a worse outcome. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal.|Screening, Weeks 1, 2, 3, 4, 5, and 6|Titration Period Safety Population. Only participants with values at both Screening and each respective visit were included in the change from screening analysis; n=number of participants analyzed for the given parameter at the specified timepoint.||Units on a scale||Standard Deviation|Mean
680296|NCT01571362|Secondary|Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Right Now|BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; higher scores indicate greater pain.|Weeks 2, 4, 8, and 12|ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for pain right now at the specified timepoint.||Units on a Scale||Standard Error|Least Squares Mean
680284|NCT01571362|Secondary|Median Time to Treatment Discontinuation for Investigator-Reported Lack of Efficacy During the Double-Blind Treatment Period|If there was no event for a participant, time to the event was considered censored at Day 84 or before Day 84 at time of treatment discontinuation for another reason. The survival duration begins on the date of first dose in the Double-Blind period and is calculated as the [date of event or discontinuation - date of first dose in Double-Blind Period +1].|Week 1 up to Week 12|ITT Population; an event was defined as a participant with treatment discontinuation for investigator-reported lack of efficacy.||days||95% Confidence Interval|Median
680285|NCT01571362|Secondary|Percentage of Participants Discontinuing Treatment for Investigator-Reported Lack of Efficacy|If there was no event for a participant, time to the event was considered censored at Day 84 or before Day 84 at time of treatment discontinuation for another reason.|Week 1 up to Week 12|ITT Population; an event was defined as a participant with treatment discontinuation for investigator-reported lack of efficacy.||Percentage of participants|||Number
680286|NCT01571362|Secondary|Median Time to 20%, 30%, 40%, or 50% Loss of Analgesic Response From Baseline During the Double-Blind Treatment Period|The percentage of lost analgesic response was defined as: (rolling seven day mean pain score during Double-Blind Period - Randomization Baseline pain intensity score) divided by Randomization Baseline pain intensity score times 100. If there was no event for a participant, time to the event was considered censored at Day 84 or before Day 84 at the time of the last diary pain score. The survival duration began on the date of first dose of study drug in the Double-Blind Period and was calculated as the [date of event or last diary pain score - date of first dose in Double-Blind Treatment +1].|Randomization Baseline, up to Week 12|ITT Population; an event was defined as a participant with 20%, 30%, 40%, or 50% loss of analgesic response from Randomization Baseline.||days||95% Confidence Interval|Median
680287|NCT01571362|Secondary|Percentage of Participants With a 20%, 30%, 40%, or 50% Loss of Analgesic Response From Randomization Baseline During the Double-Blind Treatment Period|The percentage of lost analgesic response is defined as: (rolling 7-day mean pain score during Double-Blind Period - Randomization Baseline pain intensity score) divided by Randomization Baseline pain intensity score times 100. If there was no event for a participant, time to the event was considered censored at Day 84 or before Day 84 at the time of the last diary pain score. The survival duration began on the date of first dose of study drug in the Double-Blind Period and was calculated as the [date of event or last diary pain score - date of first dose in Double-Blind Treatment +1].|Randomization Baseline, up to Week 12|ITT Population; an event was defined as a participant with 20%, 30%, 40%, or 50% loss of analgesic response from Randomization Baseline.||Percentage of participants|||Number
680288|NCT01571362|Secondary|Median Time to 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to Randomization Baseline|The percentage of analgesic response is defined as: (rolling 7-day mean pain score during Titration Period - Screening Period pain intensity score) divided by Screening Period pain intensity score times 100. If there was no event for a participant, time to the event was considered censored at Day 42 of the Titration Period or before Day 42 of the Titration Period at the time of the last diary pain score. The survival duration begins on the date of first dose of study drug in the Titration Period and is calculated as the [date of event or last diary pain score - date of first dose in Titration Period +1].|Screening, Randomization Baseline (up to 6 weeks)|ITT Population; an event was defined as a participant with 20%, 30%, 40% or 50% analgesic response from Screening.||days||95% Confidence Interval|Median
680289|NCT01571362|Secondary|Percentage of Participants With a 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to Randomization Baseline|The percentage of analgesic response is defined as: (rolling 7-day mean pain score during Titration Period - Screening Period pain intensity score) divided by Screening Period pain intensity score times 100.|Screening, Randomization Baseline (up to 6 weeks)|ITT Population; an event was defined as a participant with 20%, 30%, 40%, or 50% analgesic response from Screening.||Percentage of participants|||Number
680290|NCT01571362|Secondary|Median Time to 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to End of Open-Label Treatment|The percentage of analgesic response is defined as: (rolling 7-day mean pain score during Titration Period minus (-) Screening Period pain intensity score) divided by Screening Period pain intensity score times 100. An event was defined as a participant with 20, 30, 40, or 50% analgesic response from Screening. If there was no event for a participant, time to the event was considered censored at Day 42 of the Titration Period or before Day 42 of the Titration Period at the time of the last diary pain score. The survival duration begins on the date of first dose of study drug in the Titration Period and is calculated as the [date of event or last diary pain score - date of first dose in Titration Period +1].|Screening, Week 4, 5, or 6|Titration Period Safety Population; an event was defined as a participant with 20%, 30%, 40%, or 50% analgesic response from Screening.||days||95% Confidence Interval|Median
680291|NCT01571362|Secondary|Percentage of Participants With a 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to End of Open-Label Treatment|The percentage of analgesic response is defined as: (rolling 7-day mean pain score during Titration Period - Screening Period pain intensity score) divided by Screening Period pain intensity score times100.|Screening, Week 4, 5 or 6|Titration Period Safety Population; an event was defined as a participant with 20%, 30%, 40%, or 50% analgesic response from Screening.||Percentage of participants|||Number
680292|NCT01571362|Secondary|Average Daily Use of Rescue Acetaminophen (Milligrams Per Day [mg/Day]) During the Double-Blind Treatment Period|The amount of acetaminophen administered for each treatment during the Double-Blind Treatment Period. Average daily use calculated as: total dose of rescue medication during Double-Blind Period divided by the number of days in Double-Blind Period.|Daily from Day 1 of the Double-Blind Period through Week 12|ITT Population||Average mg/day||Standard Error|Least Squares Mean
680293|NCT01571362|Secondary|Area Under the Curve (AUC) of eDiary NRS-Pain Scores From Randomization Baseline to Final 2 Weeks of the Double-Blind Treatment Period (Weeks 11 and 12)|NRS-Pain scores based on an 11-point numerical rating scale from 0 (no pain) to 10 (worst possible pain). AUC was calculated using daily change from Baseline scores from Baseline until the last dose date in the Double-Blind Treatment Period. AUC was calculated for each participant using the linear trapezoidal method. Higher scores indicate greater pain.|Randomization Baseline, Weeks 11 and 12|ITT Population; linear interpolation was used for internal missing values, with addition of 0 to the AUC for missing values from early discontinuation.||Change in units on a scale*days||Standard Error|Least Squares Mean
680298|NCT01571362|Secondary|Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Least Pain|BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain.|Weeks 2, 4, 8, and 12|ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for least pain at the specified timepoint.||Units on a Scale||Standard Error|Least Squares Mean
680299|NCT01571362|Secondary|Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Worst Pain|BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain.|Weeks 2, 4, 8 and 12|ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for worst pain at the specified timepoint.||Units on a Scale||Standard Error|Least Squares Mean
680300|NCT01571362|Secondary|Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Interference Index|Pain Interference Index is the mean of the scores for the 7 items of the BPI-sf; range is 0=Does not interfere to 10=Completely interferes.|Weeks 2, 4, 8, and 12|ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for pain interference index at the specified timepoint.||Units on a Scale||Standard Error|Least Squares Mean
680301|NCT01571362|Secondary|Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Severity Index|Pain Severity Index is the mean of the 4 pain scores (worst, least, average, and right now) on the BPI-sf; range is 0=No pain to 10=Pain as bad as you can imagine; a higher score indicates greater pain severity.|Weeks 2, 4, 8, and 12|ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for pain severity index at the specified timepoint.||Units on a Scale||Standard Error|Least Squares Mean
680302|NCT01571362|Secondary|Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Right Now|BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain.|Weeks 2, 4, 8, and 12|ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for pain right now at the specified timepoint.||Units on a Scale||Standard Error|Least Squares Mean
680303|NCT01571362|Secondary|Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Average Pain|BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain.|Weeks 2, 4, 8, and 12|ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for average pain at the specified timepoint.||Units on a Scale||Standard Error|Least Squares Mean
680304|NCT01571362|Secondary|Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Least Pain|BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain.|Weeks 2, 4, 8, and 12|ITT Population - imputed values at early termination. Imputation by LOCF; n=number of participants assessed for least pain at the specified timepoint.||Units on a Scale||Standard Error|Least Squares Mean
680305|NCT01571362|Secondary|Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Worst Pain|BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain.|Weeks 2, 4, 8, and 12|ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for worst pain at the specified timepoint.||Units on a Scale||Standard Error|Least Squares Mean
680306|NCT01571362|Secondary|Change From Screening Period to Randomization Baseline in BPI-sf: Worst Pain, Least Pain, Average Pain, Pain Right Now, Pain Severity Index, Pain Interference Index|BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain. Pain Severity Index is the mean of the 4 pain scores (worst, least, average, and right now) on the BPI-sf; range is 0=No pain to 10=Pain as bad as you can imagine; A higher score indicates greater pain severity. Pain Interference Index is the mean of the scores for the 7 items of the BPI-sf; range is 0=Does not interfere to 10=Completely interferes.|Screening, Randomization Baseline|ITT Population - observed cases; n=number of participants assessed for the given parameter at the specified timepoint.||units on scale||Standard Deviation|Mean
680307|NCT01571362|Secondary|Change From Screening Period to End of Open-Label Treatment in Brief Pain Inventory - Short Form (BPI-sf): Worst Pain, Least Pain, Average Pain, Pain Right Now, Pain Severity Index, Pain Interference Index|BPI-sf is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions. BPI-sf includes 4 questions that assess pain intensity (worst, least, average, right now) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain. Pain Severity Index is the mean of the 4 pain scores (worst, least, average, and right now) on the BPI-sf; range is 0=No pain to 10=Pain as bad as you can imagine; A higher score indicates greater pain severity. Pain Interference Index is the mean of the scores for the 7 items of the BPI-sf; range is 0=Does not interfere to 10=Completely interferes.|Screening, Week 4, 5, or 6|Titration Period Safety Population: defined as all participants who received any amount of ALO-02 capsules during the Open-Label Conversion and Titration Period; imputation using the LOCF method. n=number of participants contributing to the mean for the specified parameter.||Units on a Scale||Standard Deviation|Mean
680308|NCT01571362|Secondary|Percentage of Participants With Improvement in Weekly Average eDiary NRS-Pain Scores From Screening to Final 2 Weeks of the Double-Blind Treatment Period (Average of Weeks 11 and 12) by Cumulative Percent Reduction ≥50%|Weekly average Diary NRS-pain scores are derived from the daily pain NRS and calculated as the mean of the last 7 days. Scores range from 0 = no pain to 10 = worst possible pain. Higher scores indicate greater pain.|Weeks 11 and 12|ITT Population||percentage of participants|||Number
680309|NCT01571362|Secondary|Percentage of Participants With Improvement in Weekly Average eDiary NRS-Pain Scores From Screening to Final 2 Weeks of the Double-Blind Treatment Period (Average of Weeks 11 and 12) by Cumulative Percent Reduction ≥40%|Weekly average Diary NRS-pain scores are derived from the daily pain NRS and calculated as the mean of the last 7 days. Scores range from 0 = no pain to 10 = worst possible pain. Higher scores indicate greater pain.|Weeks 11 and 12|ITT Population||percentage of participants|||Number
680310|NCT01571362|Secondary|Percentage of Participants With Improvement in Weekly Average eDiary NRS-Pain Scores From Screening to Final 2 Weeks of the Double-Blind Treatment Period (Average of Weeks 11 and 12) by Cumulative Percent Reduction ≥30%|Weekly average Diary NRS-pain scores are derived from the daily pain NRS and calculated as the mean of the last 7 days. Scores range from 0 = no pain to 10 = worst possible pain. Higher scores indicate greater pain.|Weeks 11 and 12|ITT Population||percentage of participants|||Number
680311|NCT01571362|Secondary|Percentage of Participants With Improvement in Weekly Average eDiary NRS-Pain Scores From Screening to Final 2 Weeks of the Double-Blind Treatment Period (Average of Weeks 11 and 12) by Cumulative Percent Reduction of Greater or Equal to (≥) 20%|Weekly average Diary NRS-pain scores are derived from the daily pain NRS and calculated as the mean of the last 7 days. Scores range from 0 equals (=) no pain to 10 = worst possible pain. Higher scores indicate greater pain.|Weeks 11 and 12|ITT Population||percentage of participants|||Number
680312|NCT01571362|Secondary|Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit).|Measure represents the score at Randomization Baseline / score at Week 12 (or Early Termination) in PGA, a global evaluation that utilizes a 5-point Likert scale with a score of 1 being the best (Very Good) and a score of 5 being the worst (Very Poor).|Randomization Baseline, Week 12|ITT Population; percentage based on the number of participants who had non-missing values at Randomization Baseline and Week 12/early termination for each treatment. Imputation using LOCF method.||Percentage of participants|||Number
680313|NCT01571362|Secondary|Change in Roland-Morris Disability Questionnaire (RMDQ) Total Score From Randomization Baseline to the End of Double-Blind Week 12 (or Final Visit).|The RMDQ is a 24-item questionnaire designed to measure self-rated disability due to back pain. An individual participant’s score can vary from 0 (no disability) to 24 (severe disability), with a lower score indicating better function; higher score indicating greater disability.|Week 12|ITT Population; imputation using last observation carried forward (LOCF) method.||Units on a Scale||Standard Error|Least Squares Mean
680314|NCT01571362|Primary|Change in Weekly Average Electronic Diary (eDiary) Numeric Rating Scale -Pain (NRS-Pain) Score From Randomization Baseline to Final 2 Weeks (Average of Weeks 11 and 12)|Weekly average diary NRS-Pain scores were derived from the daily NRS-pain scale and calculated as the mean of the last 7 days. NRS-Pain scores based on an 11-point numerical rating scale from 0 (no pain) to 10 (worst possible pain). Higher scores indicate greater pain.|Weeks 11 and 12|Intent-to-Treat (ITT) Population: all participants who were randomized into the Double-Blind Treatment Period and received at least 1 dose of study drug after randomization; the averaged value for each participant from the 100 imputed datasets were used. Hybrid multiple and single imputation were applied, depending on reason for discontinuation.||Units on a Scale||Standard Error|Least Squares Mean
680315|NCT01571232|Secondary|The Change in Mean Central Amplitude on Multi-focal ERG From Baseline.|To assess the change in mean central amplitude on multi-focal ERG from baseline to 6 months for each treatment arm.|6 months|||nV/deg2||Standard Error|Mean
680316|NCT01571232|Secondary|The Change in Mean Macular Sensitivity on Microperimetry From Baseline|To assess the change in macular sensitivity on microperimetry from baseline to 6 months for each treatment arm.|6 months||||||
680317|NCT01571232|Secondary|The Change in Macular Leakage on Fluorescein Angiography From Baseline|To qualitatively assess the change in macular leakage on fluorescein angiography from baseline to 6 months for each treatment arm.|6 months||||||
680318|NCT01571232|Primary|The Change in Central Foveal Thickness (Microns on High Resolution OCT).|The measure the change in central foveal thickness for each treatment group from baseline to 6 months.|6 months|||microns||Standard Error|Mean
680319|NCT01571232|Primary|The Change in Visual Acuity (Number of ETDRS Letters).|The measure the change in ETDRS letters for each treatment group from baseline to 6 months.|6 months|||ETDRS letters||Standard Error|Mean
680320|NCT01570751|Secondary|Number of Adverse Events (AEs)|Number of treatment emergent adverse events (TEAEs) from week 0 to week 16 of the randomised treatment periods. A TEAE was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. TEAEs were attributed to the treatment given in the period in which the event occurred.|From baseline to the end of each 16 week treatment period.|The safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or its comparator.||events|||Number
680321|NCT01570751|Secondary|Change in FPG From the End of Treatment Period A Until After 4 Weeks of Treatment in Treatment Period B|Values of FPG in mmol/L from the end of treatment period A until after 4 weeks of treatment in treatment period B.|Week 16, week 20|The FAS included all randomised subjects and missing data was imputed using LOCF. For 19 subjects the FPG values were missing.||mmol/L||Standard Deviation|Mean
680322|NCT01570751|Secondary|Change From Baseline in Central Laboratory Measured Fasting Plasma Glucose (FPG) at the End of Each 16 Week Treatment Period|Values of FPG in mmol/L from baseline to each 16 weeks of treatment periods.|Week 0, week 16, week 32|The FAS included all randomised subjects and missing data was imputed using LOCF. For 17 subjects in IDeg treatment A and 16 subjects in IGlar treatment B, FPG values were missing at the period of baseline and did not contribute to the analysis.||mmol/L||Standard Deviation|Mean
680323|NCT01570751|Secondary|Change in PRO Scores From the End of Treatment Period A Until After 4 Weeks of Treatment in Treatment Period B|SF-36 and TRIM-DD total scores were measured at the end of treatment A (week 16) and 4 weeks into treatment B (week 20). Responses were measured on a scale of 0 to 100, where higher scores indicated a better quality of life and higher insulin device satisfaction on the SF-36 and TRIM-DD questionnaires, respectively.|Week 16, week 20|The FAS included all randomised subjects. For 10 subjects, the PRO scores were missing.||scores on a scale||Standard Deviation|Mean
680335|NCT01570686|Secondary|Change From Baseline (Visit 3) to End of Study (Week 8) in Mean 24 Hour Ambulatory Diastolic Blood Pressure (maDBP)|24 hour ambulatory blood pressure measurement (ABPM) were taken twice, at baseline and at the end of 8 weeks. An Ambulatory Blood Pressure Monitoring device (ABPM) was attached to the non-dominant arm. The mean change of 24 hours maDBP from baseline to week 8 was estimated using an Analysis of Covariance (ANCOVA) model by using treatment, region as factors, and baseline as covariate.|Baseline, week 8|Full Analysis Set (FAS): consisted of all randomized patients. Mis-randomized patients were excluded from the FAS. Patients with ABPM measurements at both baseline and week 8 were included in this analysis.||mmHg||Standard Error|Least Squares Mean
680324|NCT01570751|Secondary|Change in Patient Reported Outcome (PRO) Scores From Baseline to the End of Each 16 Week Treatment Period|Changes in subjects quality of life and insulin device satisfaction were evaluated using the following PROs: the Short-Form 36 Health Survey version 2 (SF-36) and the Treatment Related Impact Measure–Diabetes Device (TRIM-DD). PRO total scores were measured from baseline to the end of each 16-week treatment period. Responses were measured on a scale of 0 to 100, where higher scores indicated a better quality of life and higher insulin device satisfaction on the SF-36 and TRIM-DD questionnaires, respectively.|Week 0, week 16 of each treatment period.|The FAS included all randomised subjects and missing data was imputed using LOCF. For 8 subjects in each treatment group the values were missing at the period of baseline and did not contribute to the analysis.||scores on a scale||Standard Deviation|Mean
680325|NCT01570751|Primary|Change From Baseline (Visit 18) in Glycosylated Haemoglobin (HbA1c) at the End of Each 16 Week Treatment Period|Values for change in HbA1c after each 16 weeks of treatment periods A and B.|Week 0, week 16 of each treatment period.|The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF). For 7 subjects in IDeg treatment A and 7 subjects in IGlar treatment B, HbA1c values were missing at the period of baseline and did not contribute to the analysis.||percentage of glycosylated haemoglobin||Standard Deviation|Mean
680326|NCT01570686|Secondary|Number of Patients With Adverse Events, Serious Adverse Events and Death||8 weeks|Safety Set (SAF): consisted of all patients who received at least one dose of randomized study medication.||Patients|||Number
680327|NCT01570686|Secondary|Change From Baseline to Week 8 in Plasma Renin Concentration (PRC)|Biomarkers related to hypertension-related pathophysiology were evaluated in this study, such as plasma renin concentration (PRC). Blood samples were taken at Visit 3 (baseline) and Visit 6 (week 8). The difference between baseline and week 8 was calculated.|Baseline, Week 8|Full Analysis Set (FAS): consisted of all randomized patients. Mis-randomized patients were excluded from the FAS. Patients with both baseline and week 8 measurement for PRC are included in this analysis.||ng/L||Standard Deviation|Mean
680328|NCT01570686|Secondary|Change From Baseline to Week 8 in Plasma Renin Activity (PRA)|Biomarkers related to hypertension-related pathophysiology were evaluated in this study, such as plasma renin activity (PRA) . Blood samples were taken at Visit 3 (baseline) and Visit 6 (week 8).The difference between baseline and week 8 was calculated.|Baseline, Week 8|Full Analysis Set (FAS): consisted of all randomized patients. Mis-randomized patients were excluded from the FAS. Patients with both baseline and week 8 measurement for PRA are included in this analysis.||ng/mL/hr||Standard Deviation|Mean
680329|NCT01570686|Secondary|Pharmacokinetic of Aliskiren: Time to Reach the Maximum Concentration (Tmax) After Drug Administration in Fasted vs. Fed|Blood samples were collected at Week 4 and Week 8 in a subset of patients (approximately 15% of each treatment group) for PK analysis.|Week 4 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose) and week 8 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose)|Pharmacokinetics set included all patients who had evaluable aliskiren concentration data with no protocol deviations that presumably affect PK results were included in the pharmacokinetic evaluations.||Hour||Standard Deviation|Mean
680330|NCT01570686|Secondary|Pharmacokinetic of Aliskiren: The Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau) in Fasted vs. Fed|Blood samples were collected at Week 4 and Week 8 in a subset of patients (approximately 15% of each treatment group) for PK analysis.|Week 4 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose) and week 8 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose)|Pharmacokinetics set included all patients who had evaluable aliskiren concentration data with no protocol deviations that presumably affect PK results were included in the pharmacokinetic evaluations.||ng*h/mL||Standard Deviation|Mean
680331|NCT01570686|Secondary|Pharmacokinetic (PK) of Aliskiren: The Observed Maximum Plasma Concentration (Cmax) Following Drug Administration in Fasted vs. Fed|Blood samples were collected at Week 4 and Week 8 in a subset of patients (approximately 15% of each treatment group) for PK analysis.|Week 4 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose) and week 8 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose)|Pharmacokinetics set included all patients who had evaluable aliskiren concentration data with no protocol deviations that presumably affect PK results were included in the pharmacokinetic evaluations||ng/mL||Standard Deviation|Mean
680332|NCT01570686|Secondary|Percentage of Patients Achieving a Successful Response in Systolic Blood Pressure Reduction|Successful response in systolic blood pressure reduction at end of 8-week treatment was defined as msSBP <140 mmHg or a reduction in msSBP ≥ 20 mmHg from baseline.|Baseline, Week 8|Full Analysis Set (FAS): consisted of all randomized patients. Mis-randomized patients were excluded from the FAS. Patients with mean sitting SBP measurement at baseline and over 8 weeks were included in this analysis.||Percentage of patients|||Number
680333|NCT01570686|Secondary|Change From Baseline (Visit 3) to End of Study (8 Weeks) in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)|Sitting blood pressure (BP) was measured at trough (approximately 24 hours ± 3 hours post dose) and recorded at all study visits. At the first study visit, the BP was checked in both arms and the arm with higher systolic BP (SBP) was used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for five minutes, systolic and diastolic blood pressures (msSBP and msDBP) were measured four times using a standard mercury sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 2 minute intervals and the mean of all four sitting blood pressure measurements was used as the average sitting office blood pressure for that visit. The analysis of covariance (ANCOVA) model used treatment, region as factors, and baseline as covariate.|Baseline, Week 8|Full Analysis Set (FAS): consisted of all randomized patients. Mis-randomized patients were excluded from the FAS. Patients with official mean sitting blood pressure measurements both at baseline and week 8 were icluded in this analysis.||mmHg||Standard Error|Least Squares Mean
680334|NCT01570686|Secondary|Percentage of Patients Achieving Blood Pressure Control|Patients achieving blood pressure control were patients who, at week 8, had a mean sitting systolic blood pressure (msSBP)/ mean sitting diastolic blood pressure (msDBP) < 140/90 mmHg|8 weeks|Full Analysis Set (FAS): consisted of all randomized patients. Mis-randomized patients were excluded from the FAS. Patients with mean sitting blood pressure measurement over 8 weeks were included in this analysis.||Percentage of patients|||Number
680336|NCT01570686|Primary|Change From Baseline (Visit 3) to End of Study (Week 8) in Mean 24 Hour Ambulatory Systolic Blood Pressure (maSBP)|24 hour ambulatory blood pressure measurement (ABPM) were taken twice, at baseline and at the end of 8 weeks. An Ambulatory Blood Pressure Monitoring device (ABPM) was attached to the non-dominant arm. The mean change of 24 hours maSBP from baseline to week 8 was estimated using an Analysis of Covariance (ANCOVA) model by using treatment, region as factors, and baseline as covariate.|Baseline, week 8|Full Analysis Set (FAS): consisted of all randomized patients. Mis-randomized patients were excluded from the FAS. Patients with ABPM measurements at both baseline and week 8 were included in this analysis.||mmHg||Standard Error|Least Squares Mean
680337|NCT01570634|Secondary|Side-effects and Complications|Compare side-effects and complications|42 days|The study was terminated early due to slow enrollment. One of the two patients enrolled took less than 50% of the prescribed study drug.|||||
680338|NCT01570634|Secondary|Absence of Relapse|Compare sustained clinical response|42 days|The study was terminated early due to slow enrollment. One of the two patients enrolled took less than 50% of the prescribed study drug.|||||
680339|NCT01570634|Secondary|Resolution of Abdominal Pain|Compare time to resolution of abdominal pain|14 days|The study was terminated early due to slow enrollment. One of the two patients enrolled took less than 50% of the prescribed study drug.|||||
680340|NCT01570634|Secondary|Stools Per Day|Compare the number of liquid stools per day during treatment period|14 days|The study was terminated early due to slow enrollment. One of the two patients enrolled took less than 50% of the prescribed study drug.|||||
680341|NCT01570634|Primary|Resolution of Diarrhea|To evaluate the safety and efficacy of CASAD added to the standard-of-care for the therapy of Clostridium difficile infection (C. difficile).|42 days|The study was terminated early due to slow enrollment. Of the 2 patients enrolled, one took less than 50% of the prescribed study drug. The results are not evaluable.|||||
680342|NCT01570309|Primary|Inflammation|Median within subject change in IL-12 levels between baseline and week 12 in active and placebo groups|Baseline to week 12|||pg/ml||Inter-Quartile Range|Median
680343|NCT01570309|Primary|Inflammation|Median within subject change in cxcl-10 .levels between baseline and week 12 in active and placebo groups|Baseline to 12 weeks|||pg/ml||Inter-Quartile Range|Median
680344|NCT01570309|Primary|Inflammation|Median within subject change in interferon-gamma levels between baseline and week 12 in active and placebo groups|Baseline to 12 weeks|||pg/ml||Inter-Quartile Range|Median
680345|NCT01570309|Primary|Inflammation -|Median within subject change in hs-CRP levels between baseline and week 12 in active and placebo groups|Baseline and 12 weeks|||mg/dl||Inter-Quartile Range|Median
680346|NCT01570309|Primary|Endothelial Function|Endothelial function was measured using peripheral arterial tonometry expressed as the reactive hyperemia index. The index is derived from the ratio of the post-to-pre occlusion peripheral arterial tonometry signal amplitude of the tested arm, divided by the post –to-pre occlusion ratio of the control arm. Median within subject change in endothelial function as measured by reactive hyperemia peripheral arterial tonometry index in each group is presented.|Baseline and 12 weeks|Assuming a standard deviation of 0.6 in the change in RH-PAT score from baseline to 12 weeks, we estimated that the study would need a sample size of 45 patients per treatment group to have 80% power at a two tailed alpha=0.05 level to detect a minimum difference in change in RH-PAT score of 0.36 between treatment groups.||reactive hypermia index||Inter-Quartile Range|Median
680347|NCT01570244|Primary|C24,ss of Levonorgestrel|measured concentration of the analyte at the end of dosing interval under steady state conditions of levonorgestrel|on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 h after drug administration|PK set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
680348|NCT01570244|Primary|Cmax,ss of Levonorgestrel|maximum measured concentration over the uniform dosing interval under steady state conditions of levonorgestrel|on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 h after drug administration|PK set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
680349|NCT01570244|Primary|AUCτ,ss of Levonorgestrel|Area under the curve over the dosing interval τ under steady state conditions of levonorgestrel|on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 h after drug administration|PK set||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
680350|NCT01570244|Secondary|Number of Participants With Drug Related Adverse Events|number of participants with investigator-defined drug related adverse events|from drug administration up to 14 days|treated set||participants|||Number
680351|NCT01570244|Secondary|Clinical Relevant Abnormalities for Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG.|Clinical relevant abnormalities for Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.|from drug administration up to 14 days|Treated set: This subject set included all 16 subjects who were administered trial medication and were documented to have taken at least 1 dose of investigational treatment.||participants|||Number
680352|NCT01570244|Primary|C24,ss of Ethinylestradiol|measured concentration of the analyte at the end of dosing interval under steady state conditions of ethinylestradiol|on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 h after drug administration|PK set||pg/mL||Geometric Coefficient of Variation|Geometric Mean
680353|NCT01570244|Primary|Cmax,ss of Ethinylestradiol|maximum measured concentration over the uniform dosing interval under steady state conditions of ethinylestradiol|on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 h after drug administration|PK set||pg/mL||Geometric Coefficient of Variation|Geometric Mean
680354|NCT01570244|Primary|AUCt,ss of Ethinylestradiol|Area under the curve over the dosing interval t under steady state conditions of ethinylestradiol|on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 hours (h) after drug administration|Pharmacokinetic (PK) set: all subjects in the treated set who provided at least 1 observation for at least 1 primary pharmacokinetic endpoint, who did not have important protocol violations relevant to the evaluation of PK endpoints, and who did not have vomiting until 2·median tmax,ss of ethinylestradiol or levonorgestrel on Day 13 or on Day 8.||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
680364|NCT01569841|Secondary|Number of Treatment Emergent Confirmed Hypoglycaemic Episodes|A hypoglycaemic episode was defined as treatment emergent if the onset of the episode occurred after the first administration of investigational medicinal product (IMP), and no later than 7 days after the last day on trial product. Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia or minor hypoglycaemic episodes. Severe hypoglycaemic episodes: requiring assistance to administer carbohydrate, glucagon or other resuscitative actions. Minor hypoglycaemic episodes: able to treat her/himself and plasma glucose below 3.1 mmol/L.|Hypoglycemic episodes reported within each 6 week treatment period.|The SAS included all subjects who received at least one dose of the investigational product or its comparator.||events|||Number
680365|NCT01569841|Secondary|Number of Treatment Emergent Adverse Events (AEs)|Number of treatment emergent adverse events (TEAEs). An AE was defined as treatment emergent if the onset date was on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. Severity was assessed by investigator.|Within each week 6 treatment period|The safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or its comparator.||events|||Number
680366|NCT01569841|Secondary|Glycosylated Haemoglobin (HbA1c)|HbA1c after 6 weeks of treatment in each treatment period.|At the end of each 6 week treatment period.|The FAS included all randomised subjects. One subject from the IGlar to IDeg treatment sequence withdrew from the trial during treatment period A while taking IGlar.||percentage of glycosylated haemoglobin||Standard Deviation|Mean
680367|NCT01569841|Secondary|Fasting Plasma Glucose (FPG)|FPG after 6 weeks of treatment in each treatment period.|At the end of each 6 week treatment period.|The FAS included all randomised subjects. One subject from the IGlar to IDeg treatment sequence withdrew from the trial during treatment period A while taking IGlar.||mmol/L||Standard Deviation|Mean
680368|NCT01569841|Secondary|Mean Interstitial Glucose (IG) Based on 14 Days of CGM|The observed mean of IG profile was obtained as the average value of area under the IG profile divided by the actual assessment time interval during the last 2 weeks of the 6-week treatment period.|CGM monitoring occurred during the last 2 weeks of the 6-week treatment period.|The FAS included all randomised subjects. One subject from the IGlar to IDeg treatment sequence withdrew from the trial during treatment period A while taking IGlar.||mmol/L||Standard Deviation|Mean
680369|NCT01569841|Primary|Average Time Within Glycaemic Target Range (Above 70 mg/dL and Below 130 mg/dL)|Time within the glycaemic target range [> 70 mg/dL (3.9 mmol/L) and < 130 mg/dL (7.2 mmol/L)] measured by Continuous Glucose Monitoring (CGM) in the last four hours of each dosing interval during the last 2 weeks of the 6-week treatment period.|CGM occured during the last 2 weeks of the 6 weeks treatment period.|The FAS included all randomised subjects. One subject from the IGlar to IDeg treatment sequence withdrew from the trial during treatment period A while taking IGlar.||hours||Standard Deviation|Mean
680370|NCT01569828|Primary|CLr After Multiple Dose Administration (Day 5)|Summary statistics for plasma PK parameters following 5 days QD dose of 400mg LCZ696|5 days|Pharmacokinetic analysis set||(ml/hr)||Standard Deviation|Mean
680371|NCT01569828|Primary|CL/F After Multiple Dose Administration (Day 5)|Summary statistics for plasma PK parameters following 5 days QD dose of 400mg LCZ696|5 days|Pharmacokinetic analysis set||(ml/hr)||Standard Deviation|Mean
680372|NCT01569828|Primary|T1/2 After Multiple Dose Administration (Day 5)|Summary statistics for plasma PK parameters following 5 days QD dose of 400mg LCZ696|5 days|Pharmacokinetic analysis set||(hr)||Standard Deviation|Mean
680373|NCT01569828|Primary|AUC 0-24h After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)||1 and 5 days|Pharmacokinetic analysis set||(hr*ng/mL)||Standard Deviation|Mean
680374|NCT01569828|Primary|(Cmax) After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)||1 and 5 days|Pharmacokinetic analysis set||ng/mL||Standard Deviation|Mean
680375|NCT01569828|Secondary|24 hr Sodium Urinary Excretion in Subjects With Severe Renal Impairment and Their Matched Healthy Volunteers||5 days|||mmol/day||Standard Deviation|Mean
680376|NCT01569828|Primary|Time to Reach Maximum Peak Plasma Concentration (Tmax) After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)||1 and 5 days|Pharmacokinetic analysis set||hour||Full Range|Median
680377|NCT01569815|Secondary|Change in Mean 24-hours Sodium Clearance From Baseline to Day 7|Sodium clearance will be measured in urine from baseline until Day 7|From baseline to Day 7|FAS||mmol/day||Standard Deviation|Mean
680378|NCT01569815|Primary|Amount of Drug Excreted Into the Urine From Time Zero to 24-hours Post-dose (Ae0-24) After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)|Blood samples will be collected for the determination of plasma concentrations of VAL489 (valsartan), AHU377( Sacubitril) and LBQ657 (a human metabolite of sacubitril)|Day 1 and Day 5|||ug||Standard Deviation|Mean
680379|NCT01569815|Primary|Renal Clearance From Plasma (CLr) After Multiple Dose Administration (Day 5)|Blood samples will be collected for the determination of plasma concentrations of VAL489 (valsartan), AHU377( Sacubitril) and LBQ657 (a human metabolite of sacubitril)|Day 5|FAS||mL/hr||Standard Deviation|Mean
680380|NCT01569815|Primary|Accumulation Ratio (Racc) After Multiple Dose Administration (Day 5)|Blood samples will be collected for the determination of plasma concentrations of VAL489 (valsartan), AHU377( Sacubitril) and LBQ657 (a human metabolite of sacubitril)|Day 5|FAS||Ratio (AUC0-24, day 5)/(AUC0-24, day 1)||Standard Deviation|Mean
680381|NCT01569815|Primary|Systemic Clearance From Plasma Following Extravascular Administration (CL/F) After Multiple Dose Administration (Day 5)|Blood samples will be collected for the determination of plasma concentrations of VAL489 (valsartan), AHU377( Sacubitril) and LBQ657 (a human metabolite of sacubitril)|Day 5|||mL/hr||Standard Deviation|Mean
680382|NCT01569815|Primary|Elimination Half-life (t1/2) After Multiple Dose (Day 5) Administration|Blood samples will be collected for the determination of plasma concentrations of VAL489 (valsartan), AHU377( Sacubitril) and LBQ657 (a human metabolite of sacubitril)|Day 5|FAS||hr||Standard Deviation|Mean
680383|NCT01569815|Primary|Area Under the Concentration-time Curve (AUC0-24) From Time Zero to 24- Hour Post-dose (Day 1), and After Multiple Dose Administration (Day 5)|Blood samples will be collected for the determination of plasma concentrations of VAL489 (valsartan), AHU377( Sacubitril) and LBQ657 (a human metabolite of sacubitril)|Day 1 and day 5|FAS||ng*hr/mL||Standard Deviation|Mean
680384|NCT01569815|Primary|Maximum Peak Plasma Concentration (Cmax) Observed After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)|Blood samples will be collected for the determination of plasma concentrations of VAL489 (valsartan), AHU377( Sacubitril) and LBQ657 (a human metabolite of sacubitril)|Day 1, day 5|||ng/mL||Standard Deviation|Mean
680385|NCT01569815|Primary|Time to Reach Maximum Peak Plasma Concentration (Tmax) After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)|Blood samples will be collected for the determination of plasma concentrations of VAL489 (valsartan), AHU377( Sacubitril) and LBQ657 (a human metabolite of sacubitril)|Day 1 and day 5|||hr||Full Range|Median
680386|NCT01569763|Post-Hoc|Subjects With Amenorrhea at 12 Months|Amenorrhea at 12 Months- Number of Subjects experiencing no menstrual bleeding|12 Months|Randomized subjects||participants|||Number
680387|NCT01569763|Secondary|Procedure Time|Procedure time is defined as the time from device insertion to time of device removal.|< 1 hour|Subjects completing treatment||Minutes||Standard Deviation|Mean
680388|NCT01569763|Primary|Reduction of Menstrual Bleeding to Normal or Below Normal at 12 Months|Clinical success was defined as a reduction in menstrual bleeding volume to ≤ 80 ml as measured by the alkaline hematin method (AH). Clinical success was not achieved if: (1) at one year post-treatment menstrual blood loss is greater than 80ml, as measured by AH; (2) an acute failure occurred (e.g., aborted procedure, etc.); or (3) the subject required additional therapy to control menorrhagia.|12 months|All Randomized subjects in whom treatment was attempted||participants|||Number
680389|NCT01569568|Secondary|Neuropsychological Assessment|Testing consisted of the Wechsler Abbreviated Scale of Intelligence (WASI), Comprehensive Trail Making Test (CTMT) (range 17-87), and the Behavioral Rating Inventory of Executive Function (BRIEF) (range GEC: 70-210; BRI:39-82 ; MI:41-92). The WASI includes three measures of intelligence; including, performance IQ (sum of block design and matrices sub scales; range: 40-160), verbal IQ (sum of vocabulary and similarities sub scales; range 40-160), and total IQ (sum of all four subscales; range: 80-320). The CTMT measures simple attention and executive function, it consists of five dot to dots that increase with complexity and difficulty. Higher values indicate better outcomes for all scales.|Baseline|||units on a scale||Standard Deviation|Mean
680390|NCT01569568|Primary|Fractional Anisotropy Assessed Using DTI|Fractional Anisotropy (FA) is a measure of the diffusion asymmetry within a voxel as defined by its eigenvalues. In our study, FA is being used as a measure of white matter integrity, because FA is very sensitive to small microstructural changes.Fractional anisotropy (FA) is a scalar value between zero and one (0-1) that describe anisotropy of a diffusion process. A value of zero means that diffusion is isotropic, i.e. it is unrestricted (or equally restricted) in all directions. A value of one means that diffusion occurs only along one axis and is fully restricted along all other directions.|Baseline|||units on a scale||Standard Deviation|Mean
680391|NCT01569568|Primary|Functional Connectivity of Assessed by Resting-state fMRI|Investigation of differences in functional connectivity of OTCD patients compared to healthy controls, particularly in the default-mode network (DMN) and the set-maintenance network (SMN). Participants underwent a resting-state scan using 3T fMRI. Combining independent component analysis (ICA) and region-of-interest (ROI) analyses, identified the nodes that comprised each network in each group, and assessed internodal connectivity. For each subject, this analysis generated a correlation value, which reflected the strength of functional connectivity between each ROI pair.The correlation r-values were normalized using Fisher’s r-to-Z-transform, generating z-scores. The DMN was composed of 1) anterior cingulate/medial prefrontal cortex (ACC/mPFC), 2) posterior cingulate cortex (PCC), and 3) bilateral inferior parietal lobule (IPL). The SMN was composed of 1)ACC, 2) bilateral superior frontal gyrus (SFG), and 3) bilateral anterior insula/frontal operculum (aI/fO).|Baseline|Resting state data was not acquired for several of our participants (7 controls and 4 patients). Furthermore, 3 OTCD patients were excluded from the analyses due to excessive head motion.||z-scores||Standard Deviation|Mean
680392|NCT01569568|Primary|Concentration of Glutamine and Myoinositol|"Concentration based on area under curve on 1H Magnetic Resonance Spectroscopy(MRS) and quantitated by LCModel (a method that allows automatic quantitation of spectroscopy data). A metabolite's tissue concentration is related to the integrated amplitude, the area under the curve of the MRS signal, it produces. While MRS signals are usually acquired in the time domain as free induction decays or echoes, they are usually viewed and analyzed in the frequency domain. The frequency domain representation is derived from the acquired time domain data by the Fourier Transform. The protocol we use selects 257 averages. The machine summates the data at each time point to generate one value for the area under the curve. Therefore, we don't have the measurement at each time point.
Furthermore, we measured voxels in two different brain areas containing different kinds of brain matter: one voxel was located in posterior cingulate gray matter (PCGM) and the other in parietal white matter (PWM)."|Baseline|Two OTCD patients and one healthy control were excluded due to excessive head motion.||mM||Standard Deviation|Mean
680393|NCT01569529|Primary|Program Enrollment|Rates of enrollment will be calculated as the proportion of visitors who enroll in treatment (e.g., number of enrollments/number of click-throughs from banner ads).|1-month intervals over 7 months|||proportion of click-throughs who enroll|Click-through from advertisements||Number
680394|NCT01569464|Secondary|Change From Baseline in SF-36 Physical Component Summary Score|"The SF-36 is a 36 item generic human research quality of life instrument that uses a recall period of 4 weeks. Items are grouped into 8 domains as follows: Physical Functioning (10 items), Role Physical (4 items), Bodily Pain (2 items), General Health (5 items), Vitality (4 items), Social Functioning (2 items), Role Emotional (3 items), Mental Health (5 items), and a further unscaled single item (question 2) for perceived stability or change in health (Health Transition) during the last year. The norm-based scores (based on the US general population) were used for analysis. For the PCS, the lowest and highest possible scores are 1 and 81 (rounded).
The SF–36 domains (subscores) are scored so that a higher score indicates a better health state."|Baseline to End of Maintenance Period (7 weeks)|"Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).
Out of the 150 patients in the FAS, 150 were included in this analysis.
The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables."||units on a scale||Standard Error|Least Squares Mean
680395|NCT01569464|Secondary|Change From Baseline in SF-36 Mental Component Summary Score|"The SF-36 is a 36 item generic human research quality of life instrument that uses a recall period of 4 weeks. Items are grouped into 8 domains as follows: Physical Functioning (10 items), Role Physical (4 items), Bodily Pain (2 items), General Health (5 items), Vitality (4 items), Social Functioning (2 items), Role Emotional (3 items), Mental Health (5 items), and a further unscaled single item (question 2) for perceived stability or change in health (Health Transition) during the last year. The norm-based scores (based on the US general population) were used for analysis. For the MCS, the lowest and highest possible scores are -9 and 82 (rounded).
The SF–36 domains (subscores) are scored so that a higher score indicates a better health state."|Baseline to End of Maintenance Period (approximately 7 weeks)|"Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).
Out of the 150 patients in the FAS, 150 were included in this analysis.
The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables."||units on a scale||Standard Error|Least Squares Mean
680396|NCT01569464|Secondary|Change In Total Score From Baseline To The End of Maintenance Period On Profile Of Mood States Questionnaire (POMS)|"The Profile of Mood States questionnaire (POMS) total score will be calculated as the sum of the scores for the following 5 scale scores (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Fatigue-Inertia, and Confusion-Bewilderment) and then subtracting the Vigor-Activity score. All factors have to be available for the total score to be calculated; otherwise the total score will be set to missing. The range for the POMS is 0 - 200 with a high score being negative and a low score being positive.
For the POMS questionnaire total score, descriptive statistics will be presented on both the observed and the change from Baseline to the end of the Maintenance Period values for the Full Analysis Set (FAS)."|Baseline to End of Maintenance Period (approximately 7 weeks)|"Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).
Out of the 150 patients in the FAS, 150 were included in this analysis.
The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables."||units on a scale||Standard Error|Least Squares Mean
680397|NCT01569464|Secondary|Change From Baseline To The End of Maintenance Period In Sleep Quantity Domain Score Of The Medical Outcomes Study (MOS) Sleep Scale - Revised (Sleep Scale-R)|"The Medical Outcomes Study (MOS) Sleep Scale–Revised (MOS Sleep–R) is a self-administered questionnaire measuring several important aspects of sleep that have been validated in both general and patient populations.
The MOS Sleep–R consists of 12-items. Responses for 10 of the 12 items are on a 5-point frequency scale with options ranging from “all of the time” to “none of the time”. The other two items ask about the length of time to fall asleep and the average number of hours slept per night. The sleep problems index I allows for the summary of sleep problems using an abbreviated six-item index, whereas the sleep problems index II uses nine of the 12 items of the scale to compute an overall sleep problem summary. A higher score on each scale in summary index represents a lack of sleep problems (better sleep quality). All scores are transformed linearly to range from 0 to 100, with the exception of the sleep quantity subscale, which is scored in hours."|Baseline to End of Maintenance Period (approximately 7 weeks)|"Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).
Out of the 150 patients in the FAS, 150 were included in this analysis.
The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables."||units on a scale||Standard Error|Least Squares Mean
680398|NCT01569464|Secondary|Change From Baseline To The End of Maintenance Period In Sleep Adequacy Domain Score Of The Medical Outcomes Study (MOS) Sleep Scale - Revised (MOS Sleep-R)|"The Medical Outcomes Study (MOS) Sleep Scale–Revised (MOS Sleep–R) is a self-administered questionnaire measuring several important aspects of sleep that have been validated in both general and patient populations.
The MOS Sleep–R consists of 12-items. Responses for 10 of the 12 items are on a 5-point frequency scale with options ranging from “all of the time” to “none of the time”. The other two items ask about the length of time to fall asleep and the average number of hours slept per night. The sleep problems index I allows for the summary of sleep problems using an abbreviated six-item index, whereas the sleep problems index II uses nine of the 12 items of the scale to compute an overall sleep problem summary. A higher score on each scale in summary index represents a lack of sleep problems (better sleep quality). All scores are transformed linearly to range from 0 to 100, with the exception of the sleep quantity subscale, which is scored in hours."|Baseline to End of Maintenance Period (approximately 7 weeks)|"Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).
Out of the 150 patients in the FAS, 150 were included in this analysis.
The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables."||units on a scale||Standard Error|Least Squares Mean
680399|NCT01569464|Secondary|Change From Baseline To The End of Maintenance Period In Sleep Disturbance Domain Score Of The Medical Outcomes Study (MOS) Sleep Scale - Revised (MOS Sleep-R)|"The Medical Outcomes Study (MOS) Sleep Scale–Revised (MOS Sleep–R) is a self-administered questionnaire measuring several important aspects of sleep that have been validated in both general and patient populations.
The MOS Sleep–R consists of 12-items. Responses for 10 of the 12 items are on a 5-point frequency scale with options ranging from “all of the time” to “none of the time”. The other two items ask about the length of time to fall asleep and the average number of hours slept per night. The sleep problems index I allows for the summary of sleep problems using an abbreviated six-item index, whereas the sleep problems index II uses nine of the 12 items of the scale to compute an overall sleep problem summary. A higher score on each scale in summary index represents a lack of sleep problems (better sleep quality). All scores are transformed linearly to range from 0 to 100, with the exception of the sleep quantity subscale, which is scored in hours."|Baseline to End of Maintenance Period (approximately 7 weeks)|"Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).
Out of the 150 patients in the FAS, 150 were included in this analysis.
The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables."||units on a scale||Standard Error|Least Squares Mean
680416|NCT01569152|Secondary|Change From Baseline in Hemoglobin at Week 12|Hemoglobin is the iron-containing oxygen-transport metalloprotein in red blood cells. Change from Baseline is hemoglobin at Week 12 minus hemoglobin at Baseline. This outcome measure applied to Base Study participants only.|Baseline and Week 12|Randomized participants in Base Study Phase IIa who received at least one dose of study drug and had non-missing Baseline and Week 12 hemoglobin values||gm/dL||Standard Deviation|Mean
681091|NCT01562314|Secondary|Clinical Efficacy Blood Sample Measurements - Interleukin (IL)-2|Change in serum cytokine IL-2 from Baseline to Final Visit|Baseline to end of treatment (10 week treatment period)|ITT analysis set||ng/L||Standard Deviation|Mean
680400|NCT01569464|Secondary|Change From Baseline To The End Of Maintenance Period In Daytime Somnolence Domain Score Of The Medical Outcomes Study (MOS) Sleep Scale - Revised (MOS Sleep–R)|"The Medical Outcomes Study (MOS) Sleep Scale–Revised (MOS Sleep–R) is a self-administered questionnaire measuring several important aspects of sleep that have been validated in both general and patient populations.
The MOS Sleep–R consists of 12-items. Responses for 10 of the 12 items are on a 5-point frequency scale with options ranging from “all of the time” to “none of the time”. The other two items ask about the length of time to fall asleep and the average number of hours slept per night. The sleep problems index I allows for the summary of sleep problems using an abbreviated six-item index, whereas the sleep problems index II uses nine of the 12 items of the scale to compute an overall sleep problem summary. A higher score on each scale in summary index represents a lack of sleep problems (better sleep quality). All scores are transformed linearly to range from 0 to 100, with the exception of the sleep quantity subscale, which is scored in hours."|Baseline to End of Maintenance Period (approximately 7 weeks)|"Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).
Out of the 150 patients in the FAS, 150 were included in this analysis.
The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables."||units on a scale||Standard Error|Least Squares Mean
680401|NCT01569464|Secondary|Change In Item Score From Baseline To The End Of The Maintenance Period In Daytime Tiredness (Item 6 of Restless Legs Syndrome 6 Rating Scales [RLS-6])|The RLS-6 is an 11-point scale. This 11-point scale was provided with ranges between (0 = not at all) to (10 = very severe).|Baseline to End of Maintenance Period (approximately 7 weeks)|"Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).
Out of the 150 patients in the FAS, 150 were included in this analysis.
The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables."||units on a scale||Standard Error|Least Squares Mean
680402|NCT01569464|Secondary|Change In Item Score From Baseline To The End Of The Maintenance Period In Severity of Restless Legs Syndrome (RLS) At Daytime In Activity (Item 5 of Restless Legs Syndrome 6 Rating Scales [RLS-6])|The RLS-6 is an 11-point scale. This 11-point scale was provided with ranges between (0 = none) to (10 = very severe).|Baseline to End of Maintenance Period (approximately 7 weeks)|"Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).
Out of the 150 patients in the FAS, 150 were included in this analysis.
The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables."||units on a scale||Standard Error|Least Squares Mean
680403|NCT01569464|Secondary|Change In Item Score From Baseline To The End Of The Maintenance Period In Severity Of Restless Legs Syndrome (RLS) At Daytime At Rest (Item 4 of Restless Legs Syndrome 6 Rating Scales [RLS-6])|The RLS-6 is an 11-point scale. This 11-point scale was provided with ranges between (0 = none) to (10 = very severe).|Baseline to End of Maintenance Period (approximately 7 weeks)|"Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).
Out of the 150 patients in the FAS, 150 were included in this analysis.
The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables."||units on a scale||Standard Error|Least Squares Mean
680404|NCT01569464|Secondary|Change In Item Score From Baseline To The End Of The Maintenance Period In Severity Of Restless Legs Syndrome (RLS) During The Night (Item 3 of Restless Legs Syndrome 6 Rating Scales [RLS-6])|The RLS-6 is an 11-point scale. This 11-point scale was provided with ranges between (0 = none) to (10 = very severe).|Baseline to End of Maintenance Period (approximately 7 weeks)|"Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).
Out of the 150 patients in the FAS, 150 were included in this analysis.
The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables."||units on a scale||Standard Error|Least Squares Mean
680405|NCT01569464|Secondary|Change In Item Score From Baseline To The End Of The Maintenance Period In Severity Of Restless Legs Syndrome (RLS) At Bedtime (Item 2 of Restless Legs Syndrome 6 Rating Scales [RLS-6])|The RLS-6 is an 11-point scale. This 11-point scale was provided with ranges between (0 = none) to (10 = very severe).|Baseline to End of Maintenance Period (approximately 7 weeks)|"Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).
Out of the 150 patients in the FAS, 150 were included in this analysis.
The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables."||units on a scale||Standard Error|Least Squares Mean
680406|NCT01569464|Secondary|Change In Item Score From Baseline To The End Of The Maintenance Period In Satisfaction With Sleep (Item 1 of Restless Legs Syndrome 6 Rating Scales [RLS-6])|The RLS-6 is an 11-point scale. This 11-point scale was provided with ranges between (0 = completely satisfied) to (10 = completely dissatisfied).|Baseline to End of Maintenance Period (approximately 7 weeks)|"Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).
Out of the 150 patients in the FAS, 150 were included in this analysis.
The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables."||units on a scale||Standard Error|Least Squares Mean
680407|NCT01569464|Secondary|Change In Average Of Means Of Periodic Limb Movement During Wakefulness Index (PLMWI) Change In Average Of Means Of Periodic Limb Movement During Wakefulness Index (PLMWI) For The Combination Of Multiple Suggested Immobilization Test (m-SIT)|"During each single Suggested Immobilization Test (SIT) PLMWI was measured using a validated actigraphy device. Simultaneous actigraphy of the legs was performed by an actigraphy device, which was attached to the ankle prior to the start of the SIT. The PLMWI was recorded while the subject was awake.
Scores ranged from 0 (no symptoms) to 10 (very severe symptoms) and were assessed every 10 minutes within each SIT."|Baseline to End of Maintenance Period (approximately 7 weeks)|"Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).
Out of the 150 patients in the FAS, 149 were included in this analysis.
The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables."||units on a scale||Standard Error|Least Squares Mean
680417|NCT01569152|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 12|The ESR is the rate at which red blood cells sediment in a period of one hour, and is a non-specific measure of inflammation. Change from Baseline is ESR at Week 12 minus ESR at Baseline. This outcome measure applied to Base Study participants only.|Baseline and Week 12|Randomized participants in Base Study Phase IIa who received at least one dose of study drug and had at least one post-baseline ESR assessment||mm/hr||95% Confidence Interval|Least Squares Mean
681092|NCT01562314|Secondary|Clinical Efficacy Blood Sample Measurements - C Reactive Protein (CRP)|Change in serum CRP from Baseline to Final Visit|Baseline to end of treatment (10 weeks treatment period)|ITT analysis set||mg/L||Standard Deviation|Mean
680408|NCT01569464|Primary|Change In Average Of Means Of Multiple Suggested Immobilization Test Discomfort Scale (m-SIT-DS) Values Of Each Individual Suggested Immobilization Test (SIT) For The Combination Of Multiple Suggested Immobilization Test (m SIT)|"The Multiple Suggested Immobilization Test Discomfort Scale (m-SIT-DS) was used for assessment of the sensory components of Restless Legs Syndrome (RLS) symptoms in order to provide a subjective score of the severity of RLS symptoms during each Suggested Immobilization Test (SIT).
Scores ranged from 0 (no symptoms) to 10 (very severe symptoms) and were assessed every 10 minutes within each SIT."|Baseline to End of Maintenance Period (approximately 7 weeks)|"Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).
Out of the 150 patients in the FAS, 150 were included in this analysis.
The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables."||units on a scale||Standard Error|Least Squares Mean
680409|NCT01569464|Primary|Change From Baseline To The End Of The Maintenance Period in International Restless Legs Scale (IRLS) Sum Score|"The International Restless Legs Scale (IRLS) was intended to evaluate, in a standardized way, the subjective intensity of major symptoms of Restless Legs Syndrome (RLS) and, in 2 items (9 and 10), the impact of the disease on subjects functioning in daytime activities by use of a 5-point scale for each of a total of 10 items.
In all items, the scores ranged from 0 (not present) to 4 (severe). A sum score across all 10 items was calculated for analysis, which varied between 0 (no RLS symptoms present at all) to 40 (maximum severity in all symptoms)."|Baseline to End of Maintenance Period (approximately 7 weeks)|"Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).
Out of the 150 patients in the FAS, 150 were included in this analysis.
The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables."||units on a scale||Standard Error|Least Squares Mean
680410|NCT01569438|Secondary|Genitourinary Pain Index (GUPI)|The GUPI is an instrument that is used to assess the degree of symptoms in women with genitourinary pain complaints. The sum of the items yields three subscales and a total score. The subscales are pain (0-23), urinary (0-10), and quality of life (0-12). The sum of the subscales is the total score (0-45). Higher scores indicate more severe symptoms.|Baseline and 4 Weeks|Titration Completers Population - defined as subjects who received at least 1 dose of drug, had at least 1 post-baseline efficacy measure, who titrated the dose in Week 1 of the treatment phase, and who completed the 4-week treatment phase||units on a scale||Standard Deviation|Mean
680411|NCT01569438|Secondary|O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI)|The ICSI contains 4 items that measured how problematic symptoms were for subjects with bladder pain syndrome. Each question in the ICPI was on a scale of 0-4, where each answer was given a specific rating. The sum of the item scores indicated more problematic symptoms. The index score ranged from 0-16 where higher scores indicated more problematic symptoms.|Baseline and 4 Weeks|Titration Completers Population - defined as subjects who received at least 1 dose of drug, had at least 1 post-baseline efficacy measure, who titrated the dose in Week 1 of the treatment phase, and who completed the 4-week treatment phase||units on a scale||Standard Deviation|Mean
680412|NCT01569438|Secondary|Painful Bladder/Interstitial Cystitis Symptom Diary (PBIC-SD)|The PBIC-SD was an 8-item subject self-report measure for assessing the severity of bladder pain syndrome. All items were graded on a scale from 0 (good condition) to 4 (poor condition) for a total score between 0 and 32.|Baseline and 4 Weeks|Titration Completers Population - defined as subjects who received at least 1 dose of drug, had at least 1 post-baseline efficacy measure, who titrated the dose in Week 1 of the treatment phase, and who completed the 4-week treatment phase||units on a scale||Standard Deviation|Mean
680413|NCT01569438|Primary|The Primary Efficacy Endpoint of This Study is Change in the 'Average Pain' NPRS Score.|Subjects were instructed to select a number on a scale that best described the severity of bladder pain during the past 24 hours. The scale was between 0 and 10 where 0 was no pain and 10 was the worst pain possible. The scale was completed by telephone (an interactive voice response system[IVRS]) every evening at bedtime.|Baseline and 4 Weeks|Titration Completers Population - defined as subjects who received at least 1 dose of drug, had at least 1 post-baseline efficacy measure, who titrated the dose in Week 1 of the treatment phase, and who completed the 4-week treatment phase||units on a scale||Standard Deviation|Mean
680414|NCT01569152|Secondary|Percentage of Participants With an ACR20 Response Over Time|ACR responses are numerical measurements of improvement in multiple disease assessment criteria. An ACR20 response is defined as a ≥20% improvement in 1) swollen joint count (66 joints) and tender joint count (68 joints) (0 = Absent; 1 = Present) and 2) ≥20% improvement in 3 of the following 5 assessments: a) a participant’s overall assessment of pain on a visual analog scale (VAS, no pain =0 to extreme pain =100); b) Patient’s Global Assessment of Disease Activity VAS (doing very well =0 to doing very poor =100); c) Investigator’s Global Assessment of Disease Activity VAS (doing very well =0 to doing very poor =100 ; d) participant’s assessment of function across 8 functional areas as measured by Health Assessment Questionnaire (HAQ), total scores ranging from no difficulty =0 to inability to perform tasks =24; and e) serum C-Reactive Protein (decrease indicates improvement). This outcome measure applied to Base Study participants only.|Week 1, Week 2, Week 4, Week 6, Week 18 and Week 24|Randomized participants in Base Study Phase IIa who received at least one dose of study drug and had at least one post-baseline ACR20 measurement||Percentage of participants|||Number
680415|NCT01569152|Secondary|Percentage of Participants Achieving an ACR50 Response at Week 12|ACR responses are numerical measurements of improvement in multiple disease assessment criteria. An ACR50 response is defined as a ≥50% improvement in 1) swollen joint count (66 joints) and tender joint count (68 joints) (0 = Absent; 1 = Present) and 2) ≥50% improvement in 3 of the following 5 assessments: a) a participant’s overall assessment of pain on a visual analog scale (VAS, no pain =0 to extreme pain =100); b) Patient’s Global Assessment of Disease Activity VAS (doing very well =0 to doing very poor =100); c) Investigator’s Global Assessment of Disease Activity VAS (doing very well =0 to doing very poor =100 ; d) participant’s assessment of function across 8 functional areas as measured by Health Assessment Questionnaire (HAQ), total scores ranging from no difficulty =0 to inability to perform tasks =24; and e) serum C-Reactive Protein (decrease indicates improvement). This outcome measure applied to Base Study participants only.|Week 12|Randomized participants in Base Study Phase IIa who received at least one dose of study drug and had at least one post-baseline ACR50 assessment||Percentage of participants|||Number
681626|NCT01553318|Secondary|Fibromyalgia Impact Questionnaire|Change in global symptom severity [scale range from -100 to +100] = the more negative the value is, the greater the improvement in overall symptom severity|baseline and week 10|Indeed, fibromyalgia impact questionnaire is a secondary outcome.||units on a scale||Standard Deviation|Mean
680418|NCT01569152|Secondary|Change From Baseline in Serum C-Reactive Protein (CRP) at Week 12|C-Reactive Protein is an inflammatory marker with a normal reference range of less than 0.9 mg/dL. Change from Baseline in CRP at Week 12 (Week 12 concentration minus Baseline concentration). This outcome measure applied to Base Study participants only.|Baseline and Week 12|Randomized participants in Base Study Phase IIa who received at least one dose of study drug and had at least one post-baseline serum CRP assessment||mg/dL||95% Confidence Interval|Least Squares Mean
680419|NCT01569152|Secondary|Change From Baseline in the Health Assessment Questionnaire Disability (HAQ Disability Index) at Week 12|The functional status of the participant was assessed using the Disability Index of the HAQ on a Likert scale. This 20-question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area. The overall score for the Disability Index is the mean of the 8 functional area scores and also ranges from 0 to 3, with a lower score indicating less disability. A negative change from Baseline indicates improvement. This outcome measure applied to Base Study participants only.|Baseline and Week 12|Randomized participants in Base Study Phase IIa who received at least one dose of study drug and had at least one post-baseline HAQ Disability Index assessment||Units on a scale||95% Confidence Interval|Least Squares Mean
680420|NCT01569152|Secondary|Change From Baseline in the Patient's Global Assessment of Pain (PGAP) at Week 12|A participant’s overall assessment of pain was assessed from the amount of pain due to arthritis experienced during the past 48 hours on a VAS where 0 mm = “no pain” and 100 mm = “extreme pain”. A negative change from Baseline indicates improvement. This outcome measure applied to Base Study participants only.|Baseline and Week 12|Randomized participants in Base Study Phase IIa who received at least one dose of study drug and had at least one post-baseline PGAP assessment||Units on a scale||95% Confidence Interval|Least Squares Mean
680421|NCT01569152|Secondary|Change From Baseline in the Investigator's Global Assessment of Disease Status/Activity (IGADSA) at Week 12|The Investigator's Global Assessment of Disease Status/Activity (IGADSA) is measured with scores ranging from 0 to 100 mm (VAS, 0 mm = doing very well to 100 mm = doing very poor). A negative change from Baseline indicates improvement. This outcome measure applied to Base Study participants only.|Baseline and Week 12|Randomized participants in Base Study Phase IIa who received at least one dose of study drug and had at least one post-baseline IGADSA assessment||Units on a scale||95% Confidence Interval|Least Squares Mean
680422|NCT01569152|Secondary|Change From Baseline in the Patient's Global Assessment of Disease Status/Activity (PGADSA) at Week 12|A participant’s overall assessment of pain was assessed from the amount of pain due to arthritis experienced during the past 48 hours on a VAS, where 0 mm = doing very well to 100 mm = doing very poor. A negative change from Baseline indicates improvement. This outcome measure applied to Base Study participants only.|Baseline and Week 12|Randomized participants in Base Study Phase IIa who received at least one dose of study drug and had at least one post-baseline PGADSA assessment||Units on a scale||95% Confidence Interval|Least Squares Mean
680423|NCT01569152|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at Week 12|The FACIT-F is a questionnaire that assesses self-reported tiredness, weakness, and difficulty conducting usual activities due to fatigue. FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). The higher the participant's response to the questions the greater the participant's fatigue. This outcome measure applied to Base Study participants only.|Baseline and Week 12|Due to the early termination of the study, analysis for this outcome measure was not performed according to the protocol because complete data were not available.|||||
680424|NCT01569152|Secondary|Change From Baseline in the Short Form Health Survey (SF-36) at Week 12|The SF-36 is a health-related quality of life instrument that consists of 8 multi-item scales: limitations in physical functioning due to health problems, limitations in usual role activities due to physical health problems, bodily pain, general mental health (psychological distress and well-being), limitations in usual role activities due to personal or emotional problems, limitations in social functioning due to physical or mental health problems, vitality (energy and fatigue), and general health perception. Each scale is directly transformed into a 0 to 100 scale on the assumption that each question carries equal weight. The lower the score the greater the disability i.e., a score of 0 corresponds to maximum disability and a score of 100 corresponds to no disability. This outcome measure applied to Base Study participants only.|Baseline and Week 12|Due to the early termination of the study, analysis for this outcome measure was not performed according to the protocol because complete data were not available.|||||
680425|NCT01569152|Secondary|Change From Baseline in the Simplified Disease Activity Index (SDAI) at Week 12|SDAI is the simple linear sum of the following parameters: tender joint count (TJC) and swollen joint count (SJC) based on a 28-joint assessment, Patient's Global Assessment of Disease Activity [PGA, VAS 0 to 10 cm], Investigator's Global Assessment of Disease Activity (MDGA, VAS 0 to 10 cm) and CRP levels (mg/dL). SDAI =TJC + SJC + PGA + MDGA + CRP. Overall scores can range from 0.0 to 86.0. A higher score indicated greater disease severity. This outcome measure applied to Base Study participants only.|Baseline and Week 12|Randomized participants in Base Study Phase IIa who received at least one dose of study drug and had at least one post-baseline SDAI assessment||Units on a scale||95% Confidence Interval|Least Squares Mean
680426|NCT01569152|Secondary|Change From Baseline in Swollen Joint Count at Week 12|Swollen joint count included 66 joints (same joints as for tender joint count except this excluded evaluation of hips) that were assessed for the presence of swelling. Soft tissue swelling was considered to be present if there was palpable or visible evidence of capsular distention considered to be due to either synovial thickening and/or a joint effusion. Bony swelling, nodule formation, and joint deformity were excluded from consideration. A swollen joint was scored as 0 = Absent; 1 = Present for each joint. The overall swollen joint count ranged from 0 to 66. A higher score indicated greater disease severity. This outcome measure applied to Base Study participants only.|Baseline and Week 12|Randomized participants in Base Study Phase IIa who received at least one dose of study drug and had at least one post-baseline swollen joint count||Swollen joints||95% Confidence Interval|Least Squares Mean
680427|NCT01569152|Secondary|Change From Baseline in Tender Joint Count at Week 12|Tender Joint Count was examined on 68 joints of the fingers, elbows, hips, knees, ankles, and toes distal for pain in response to pressure or passive motion at the study time points. Joint pain was scored as 0 = Absent; 1 = Present for each joint. The overall Tender Joint Count ranged from 0 to 68. A higher score indicated greater disease severity. This outcome measure applied to Base Study participants only.|Baseline and Week 12|Randomized participants in Base Study Phase IIa who received at least one dose of study drug and had at least one post-baseline tender joint count||Tender joints||95% Confidence Interval|Least Squares Mean
680428|NCT01569152|Secondary|DAS28-CRP Area Under the Curve (AUC)|DAS28-CRP AUC was to be calculated from the DAS28-CRP score versus time curve, which provided an assessment of changes in disease activity over time. The DAS28-CRP AUC was to be calculated using the trapezoidal rule as the DAS28-CRP multiplied by the duration of the assessment period (in weeks) and was to be expressed as %-weeks. A higher calculated AUC value indicates higher disease activity (worse). This outcome measure applied to Base Study participants only.|Up to 12 weeks|Due to the early termination of the study, analysis for this outcome measure was not performed according to the protocol because complete data were not available.|||||
680429|NCT01569152|Secondary|DAS28-ESR Area Under the Curve (AUC)|DAS28-ESR AUC was to be calculated from the DAS28-ESR score versus time curve, which provided an assessment of changes in disease activity over time. The DAS28-ESR AUC was to be calculated using the trapezoidal rule as the DAS28-ESR multiplied by the duration of the assessment period (in weeks) and was to be expressed as %-weeks. A higher calculated AUC value indicates higher disease activity (worse). This outcome measure applied to Base Study participants only.|Up to 12 weeks|Due to the early termination of the study, analysis for this outcome measure was not performed according to the protocol because complete data were not available.|||||
680430|NCT01569152|Secondary|Percentage of Participants Achieving DAS28-CRP Remission at Week 12|The DAS28-CRP is a continuous parameter derived from the formula: 0.56 × the square root of the tender joint count (0-28) + 0.28 × the square root of the swelling joint count (0-28) + 0.36 × the C reactive protein value (in mg/L +1) + 0.014 × Patient’s Global Assessment of Disease Activity VAS of 0-100 mm + 0.96. The DAS28-CRP is a scale ranging from 0 to 10 with higher values indicating greater RA disease activity. DAS28-CRP remission is defined as a value <2.6 at the visit. This outcome measure applied to Base Study participants only.|Week 12|Randomized participants in Base Study Phase IIa who received at least one dose of study drug and had at least one post-baseline DAS28-CRP measurement||Percentage of participants|||Number
680431|NCT01569152|Secondary|Percentage of Participants Achieving DAS28-ESR Remission at Week 12|The DAS28-ESR is a continuous parameter based upon a statistically-derived index combining tender joints (28 joints, TEN28), swollen joints (28 joints, SW28), ESR, and Patient's Global Assessment of Disease Activity VAS (GH). It is defined as follows: DAS28-ESR = 0.56 × SQRT(TEN28) + 0.28 × SQRT(SW28) + 0.70 × ln (ESR) + 0.014 × GH. SQRT = square root. The DAS28-ESR is a scale ranging from 0 to 10 with higher values indicating greater RA disease activity. DAS28-ESR remission is defined as a value <2.6 at the visit. This outcome measure applied to Base Study participants only.|Week 12|Randomized participants in Base Study Phase IIa who received at least one dose of study drug and had at least one post-baseline DAS28-ESR measurement||Percentage of participants|||Number
680432|NCT01569152|Secondary|Percentage of Participants Achieving a DAS28-CRP Response at Week 12|The DAS28-CRP is a continuous parameter based upon a statistically-derived index combining tender joints (28 joints, TEN28), swollen joints (28 joints, SW28), CRP, and Patient's Global Assessment of Disease Activity VAS (GH). It is defined as follows: DAS28-CRP = 0.56 × SQRT(TEN28) + 0.28 × SQRT(SW28) + 0.36 × ln (CRP+1) + 0.014 × GH + 0.96. The DAS28-CRP is a scale ranging from 0 to 10 with higher values indicating greater RA disease activity. Depending upon the DAS28-CRP value for a given visit, change in DAS28-CRP is categorized as follows: No Response (reduction from Baseline ≤0.6), No response or Moderate Response (reduction >0.6 - 1.2), and Moderate or Good Response (reduction >1.2). The percentage of participants with a Moderate or Good change in DAS28-CRP was reported. This outcome measure applied to Base Study participants only.|Week 12|Randomized participants in Base Study Phase IIa who received at least one dose of study drug and had at least one post-baseline DAS28-CRP measurement||Percentage of participants|||Number
680433|NCT01569152|Secondary|Percentage of Participants Achieving a DAS28-ESR Response at Week 12|The DAS28-ESR is a continuous parameter based upon a statistically-derived index combining tender joints (28 joints, TEN28), swollen joints (28 joints, SW28), ESR, and Patient's Global Assessment of Disease Activity VAS (GH). It is defined as follows: DAS28-ESR = 0.56 × SQRT(TEN28) + 0.28 × SQRT(SW28) + 0.70 × ln (ESR) + 0.014 × GH. SQRT = square root. The DAS28-ESR is a scale ranging from 0 to 10 with higher values indicating greater RA disease activity. Depending upon the DAS28-ESR value for a given visit, change in DAS28-ESR is categorized as follows: No Response (reduction from Baseline ≤0.6), No response or Moderate Response (reduction >0.6 - 1.2), and Moderate or Good Response (reduction >1.2). The percentage of participants with a Moderate or Good change in DAS28-ESR was reported. This outcome measure applied to Base Study participants only.|Week 12|Randomized participants in Base Study Phase IIa who received at least one dose of study drug and had at least one post-baseline DAS28-ESR measurement||Percentage of participants|||Number
680434|NCT01569152|Secondary|Percentage of Participants Achieving an ACR-N Response at Week 12|The ACR-N response is the minimum of the following: 1) the percent decrease from Baseline in tender joint counts (68 joints, 0 = absent, 1 = present); 2) the percent decrease from Baseline in swollen joint counts (66 joints, 0 = absent, 1 = present); and 3) the median percent decrease from Baseline for the following: a) Patient’s Global Assessment of Pain (VAS, 0 mm = “no pain” and 100 mm = “extreme pain”); b) Patient’s Global Assessment of Disease Activity (VAS, 0 mm = doing very well to 100 mm = doing very poor); c) Investigator’s Global Assessment of Disease Activity (VAS, 0 mm = doing very well to 100 mm = doing very poor); d. physical function as measured by the HAQ (Likert scale, 0 to 3 with a lower score indicating less disability); and e) CRP. This outcome measure applied to Base Study participants only.|Week 12|Due to the early termination of the study, analysis for this outcome measure was not performed according to the protocol because complete data were not available.|||||
680503|NCT01568424|Primary|Survival|"In patients who recover and do not go on to transplantation or a long-term device: Survival to 30 days post-support or to hospital discharge (whichever is longer).
In patients who do not recover and are bridged to transplant or a long-term system: Survival to induction of anesthesia for implantation of a long-term device or heart transplant."|30 days post device removal|||percentage of survival at 30 days|||Number
680435|NCT01569152|Secondary|Percentage of Participants Achieving Hybrid ACR Response at Week 12|Hybrid ACR Response evaluates the improvement in active RA by combining elements of the ACR20/50/70 with a categorical score of the mean change in the core set measures (tender joint count, swollen joint count, Patient's Global Assessment of Disease Activity, Investigator's Global Assessment of Disease Activity, disability index of the HAQ, and CRP). The mean percentage improvement from Baseline in the core set measures was computed and used with the participant's ACR20, ACR50, and ACR70 status to determine the hybrid ACR response in a lookup table. The range of values was -100 to 100, with a positive change indicating improvement. This outcome measure applied to Base Study participants only.|Week 12|Due to the early termination of the study, analysis for this outcome measure was not performed according to the protocol because complete data were not available.|||||
680436|NCT01569152|Secondary|Percentage of Participants Achieving an ACR70 Response at Week 12|ACR responses are numerical measurements of improvement in multiple disease assessment criteria. An ACR70 response is defined as a ≥70% improvement in 1) swollen joint count (66 joints) and tender joint count (68 joints) (0 = Absent; 1 = Present) and 2) ≥70% improvement in 3 of the following 5 assessments: a) a participant’s overall assessment of pain on a visual analog scale (VAS, no pain =0 to extreme pain =100); b) Patient’s Global Assessment of Disease Activity VAS (doing very well =0 to doing very poor =100); c) Investigator’s Global Assessment of Disease Activity VAS (doing very well =0 to doing very poor =100 ; d) participant’s assessment of function across 8 functional areas as measured by Health Assessment Questionnaire (HAQ), total scores ranging from no difficulty =0 to inability to perform tasks =24; and e) serum C-Reactive Protein (decrease indicates improvement). This outcome measure applied to Base Study participants only.|Week 12|Randomized participants in Base Study Phase IIa who received at least one dose of study drug and had at least one post-baseline ACR70 measurement||Percentage of participants|||Number
680437|NCT01569152|Secondary|Change From Baseline in DAS28 as Measured by C-Reactive Protein (CRP) at Week 12|The DAS28-CRP is a continuous parameter based upon a statistically-derived index combining tender joints (28 joints, TEN28), swollen joints (28 joints, SW28), CRP (an inflammatory marker), and Patient's Global Assessment of Disease Activity VAS (GH). It is defined as follows: DAS28-CRP = 0.56 × SQRT(TEN28) + 0.28 × SQRT(SW28) + 0.36 × ln (CRP+1) + 0.014 × GH + 0.96. The DAS28-CRP is a scale ranging from 0 to 10 with higher values indicating greater RA disease activity. This outcome measure applied to Base Study participants only.|Baseline and Week 12|Randomized participants in Base Study Phase IIa who received at least one dose of study drug and had both Baseline and Week 12 DAS28-CRP measurements||Units on a scale||95% Confidence Interval|Least Squares Mean
680438|NCT01569152|Secondary|Change From Baseline in Disease Activity Score (DAS28) as Measured by Erythrocyte Sedimentation Rate (ESR) at Week 12|The DAS28-ESR is a continuous parameter based upon a statistically-derived index combining tender joints (28 joints, TEN28), swollen joints (28 joints, SW28), ESR (an inflammatory marker), and Patient's Global Assessment of Disease Activity VAS (GH). It is defined as follows: DAS28-ESR = 0.56 × SQRT(TEN28) + 0.28 × SQRT(SW28) + 0.70 × ln (ESR) + 0.014 × GH. SQRT = square root. The DAS28-ESR is a scale ranging from 0 to 10 with higher values indicating greater rheumatoid arthritis (RA) disease activity. This outcome measure applied to Base Study participants only.|Baseline and Week 12|Randomized participants in Base Study Phase IIa who received at least one dose of study drug and had both Baseline and Week 12 DAS28-ESR measurements||Units on a scale||95% Confidence Interval|Least Squares Mean
680439|NCT01569152|Primary|Percentage of Participants Achieving an American College of Rheumatology (ACR) 20 Response at Week 12|ACR responses are numerical measurements of improvement in multiple disease assessment criteria. An ACR20 response is defined as a ≥20% improvement in 1) swollen joint count (66 joints) and tender joint count (68 joints) (0 = Absent; 1 = Present) and 2) ≥20% improvement in 3 of the following 5 assessments: a) a participant’s overall assessment of pain on a visual analog scale (VAS, no pain =0 to extreme pain =100); b) Patient’s Global Assessment of Disease Activity VAS (doing very well =0 to doing very poor =100); c) Investigator’s Global Assessment of Disease Activity VAS (doing very well =0 to doing very poor =100 ; d) participant’s assessment of function across 8 functional areas as measured by Health Assessment Questionnaire (HAQ), total scores ranging from no difficulty =0 to inability to perform tasks =24; and e) serum C-Reactive Protein (decrease indicates improvement). This outcome measure applied to Base Study participants only.|Week 12|Randomized participants in Base Study Phase IIa who received at least one dose of study drug and had at least one post-baseline ACR20 measurement (last observation carried forward)||Percentage of participants|||Number
680440|NCT01569126|Secondary|Change From Baseline in Bazett's and Fridericia's Corrected QT (QTcB and QTcF) Intervals|The number of participants with a maximum increase from baseline in 12-lead electrocardiogram (ECG) QTcB and QTcF intervals >30 milliseconds (ms) and >60 ms for the single-dose (SD) and multiple-dose (MD) periods is reported.|Baseline, up to Day 43 (SD period) and Baseline, up to Day 70 (MD period)|Randomized participants, in Cohorts 1, 2, and 3, who received at least 1 dose of study drug and had at least 1 postdose safety assessment.||participants|||Number
680441|NCT01569126|Secondary|Pharmacokinetics: Area Under the Concentration-Time Curve for Dosing Interval (Tau) at Steady State [AUC(Tau,Steady State)] of Multiple Doses (MD) of LY110140|Study drug was administered as LY110140 (fluoxetine hydrochloride) and its active portion, fluoxetine, was metabolized to norfluoxetine in the body. The AUC(tau,steady state) of plasma total fluoxetine and norfluoxetine during the MD period is reported.|Predose up to Day 28|Randomized participants, in Cohorts 4 and 5, who received at least 1 dose of study drug (excluding placebo) and had evaluable pharmacokinetic data.||nanograms*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
680442|NCT01569126|Secondary|Pharmacokinetics: Area Under the Concentration-Time Curve From Zero to 24 Hours [AUC(0-24)] of Multiple Doses (MD) of LY110140|Study drug was administered as LY110140 (fluoxetine hydrochloride) and its active portion, fluoxetine, was metabolized to norfluoxetine in the body. The AUC(0-24) of plasma total fluoxetine and norfluoxetine on Day 1 of the MD period is reported.|Day 1|Randomized participants, in Cohorts 4 and 5, who received at least 1 dose of study drug (excluding placebo) and had evaluable pharmacokinetic data.||nanograms*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
680557|NCT01567852|Primary|Recovery Time|Recovery was assessed using 5 criteria (blood pressure, voluntary movement, oxygen requirement, consciousness, respiratory effort). Each criteria was scored from 0-2, with a full score of 10. The patient is scored at baseline, and is deemed recovered when all criteria has reached baseline score again.|1 hour|Please see description from outcome 1||minutes||Standard Deviation|Mean
680443|NCT01569126|Secondary|Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of Multiple Doses (MD) of LY110140|Study drug was administered as LY110140 (fluoxetine hydrochloride) and its active portion, fluoxetine, was metabolized to norfluoxetine in the body. The Cmax of plasma total fluoxetine and norfluoxetine on Day 1 and Day 28 of the MD period is reported.|Days 1 and 28|Randomized participants, in Cohorts 4 and 5, who received at least 1 dose of study drug (excluding placebo) and had evaluable pharmacokinetic data.||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
680444|NCT01569126|Secondary|Pharmacokinetics: Area Under the Concentration-Time Curve From Zero to Infinity [AUC(0-infinity)] of Single Dose (SD) of LY110140|Study drug was administered as LY110140 (fluoxetine hydrochloride) and its active portion, fluoxetine, was metabolized to norfluoxetine in the body. The AUC(0-infinity) of plasma total fluoxetine and norfluoxetine during the SD period is reported.|Predose up to Day 43|Randomized participants, in Cohorts 1, 2, and 3, who received at least 1 dose of study drug and had evaluable pharmacokinetic data.||nanograms*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
680445|NCT01569126|Secondary|Pharmacokinetics: Area Under the Concentration-Time Curve From Zero to Last Time Point [AUC(0-tlast)] of Single Dose (SD) of LY110140|Study drug was administered as LY110140 (fluoxetine hydrochloride) and its active portion, fluoxetine, was metabolized to norfluoxetine in the body. The AUC(0-tlast) of plasma total fluoxetine and norfluoxetine during the SD period is reported.|Predose up to Day 43|Randomized participants, in Cohorts 1, 2, and 3, who received at least 1 dose of study drug and had evaluable pharmacokinetic data.||nanograms*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
680446|NCT01569126|Secondary|Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of Single Dose (SD) of LY110140|Study drug was administered as LY110140 (fluoxetine hydrochloride) and its active portion, fluoxetine, was metabolized to norfluoxetine in the body. The Cmax of plasma total fluoxetine and norfluoxetine during the SD period is reported.|Predose up to Day 43|Randomized participants, in Cohorts 1, 2, and 3, who received at least 1 dose of study drug and had evaluable pharmacokinetic data.||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
680447|NCT01569126|Primary|Number of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious AEs During the Multiple-Dose (MD) Period|A drug-related AE was an AE that occurred postdose or was present predose and became more severe postdose and was considered to be related to study treatment. A summary of AEs, regardless of causality, is located in the Reported Adverse Events module.|Baseline up to Day 70|Randomized participants, in Cohorts 4 and 5, who received at least 1 dose of study drug or placebo and had at least 1 postdose safety assessment.||participants|||Number
680448|NCT01569126|Primary|Number of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious AEs During the Single-Dose (SD) Period|A drug-related AE was an AE that occurred postdose or was present predose and became more severe postdose and was considered to be related to study treatment. A summary of AEs, regardless of causality, is located in the Reported Adverse Events module.|Baseline up to Day 43|Randomized participants, in Cohorts 1, 2, and 3, who received at least 1 dose of study drug and had at least 1 postdose safety assessment.||participants|||Number
680449|NCT01569087|Secondary|Incidence of Febrile Neutropenia||21 days|Modified intention-to-treat population (analysis included patients who received at least 1 injection of study drug. Patients who had missed blood sampling on visit 5 [expected time of nadir] were excluded from analysis)||participants|||Number
680450|NCT01569087|Secondary|Duration of Neutropenia From Nadir to ANC < 2,0 x 10^9 Cells/L on the First Cycle of Chemotherapy||21 days|Modified intention-to-treat population (analysis included patients who received at least 1 injection of study drug. Patients who had missed blood sampling on visit 5 [expected time of nadir] were excluded from analysis)||days||Standard Deviation|Mean
680451|NCT01569087|Secondary|Low Level (Nadir) ANC x 10^9/L||21 days|Modified intention-to-treat population (analysis included patients who received at least 1 injection of study drug. Patients who had missed blood sampling on visit 5 [expected time of nadir] were excluded from analysis)||cells x 10^9/L||Inter-Quartile Range|Median
680452|NCT01569087|Secondary|The Duration of Any Grade Neutropenia||21 days|Modified intention-to-treat population (analysis included patients who received at least 1 injection of study drug. Patients who had missed blood sampling on visit 5 [expected time of nadir] were excluded from analysis)||days||Standard Deviation|Mean
680453|NCT01569087|Secondary|Mean Duration of CTCAE Grade 4 Neutropenia||21 days|Modified intention-to-treat population (analysis included patients who received at least 1 injection of study drug. Patients who had missed blood sampling on visit 5 [expected time of nadir] were excluded from analysis)||days||Standard Deviation|Mean
680454|NCT01569087|Primary|CTCAE Grade 3/4 Neutropenia Incidence||21 days|Modified intention-to-treat population (analysis included patients who received at least 1 injection of study drug. Patients who had missed blood sampling on visit 5 [expected time of nadir] were excluded from analysis)||participants|||Number
680455|NCT01569074|Secondary|SF-36 - Comparison of the Change in MCS From Baseline Between Fostamatinib and Placebo at Week 12|SF-36 = 36-item Short Form Health Survey, as a measure of health related quality of life. Scores for 8 sub-domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Function, Role-Emotional and Mental Health) are derived and normalised to a scale of 0 to 100. The physical and mental component scores (PCS and MCS) are derived by multiplying each of these 8 scores by a constant, summing them and standardising against a population with mean of 50, standard deviation of 10. A higher score represents better quality of life. Mean changes from baseline are presented as increases from baseline (defined as post-baseline minus baseline); larger changes indicate a better clinical condition. Mean refers to change in scores at Week 12. ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once a day.|Baseline and 12 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Units on a scale||Standard Deviation|Mean
680573|NCT01567163|Secondary|Pharmacokinetics: Area Under the Concentration Versus Time Curve of Ramucirumab From Time Zero to Infinity [AUC(0-∞)] in the Presence of Docetaxel||Cycle 2: 1 hour prior to ramucirumab infusion, 0, 1, 2, 2.5, 3, 4, 6, 8, 25, 49, 73, 169, 265 and 337 hours post ramucirumab infusion|All enrolled participants who received ramucirumab and had sufficient concentration data to calculate ramucirumab AUC(0-∞) in Cycle 2.||micrograms*hour/milliliter (mcg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
680456|NCT01569074|Secondary|SF-36 - Comparison of the Change in PCS From Baseline Between Fostamatinib and Placebo at Week 12|SF-36 = 36-item Short Form Health Survey, as a measure of health related quality of life. Scores for 8 sub-domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Function, Role-Emotional and Mental Health) are derived and normalised to a scale of 0 to 100. The physical and mental component scores (PCS and MCS) are derived by multiplying each of these 8 scores by a constant, summing them and standardising against a population with mean of 50, standard deviation of 10. A higher score represents better quality of life. Mean changes from baseline are presented as increases from baseline (defined as post-baseline minus baseline); larger changes indicate a better clinical condition. Mean refers to change in scores at Week 12. ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once a day.|Baseline and 12 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Units on a scale||Standard Deviation|Mean
680457|NCT01569074|Secondary|Proportion of Patients With HAQ-DI Response at Week 12, Comparison Between Fostamatinib and Placebo|HAQ-DI: Health Assessment Questionnaire – Disability Index, a measure of physical function. The HAQ-DI score is calculated by summing scores from 8 sub-categories (ie, scores for patient ability in dressing and grooming, rising, eating, walking, hygiene, reach, grip and common daily activities) and dividing by the number of categories completed. The HAQ-DI score takes values between 0 and 3, with higher score indicating greater disability. HAQ-DI response is a reduction from baseline in HAQ-DI greater than or equal to the minimally important difference (0.22). BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, OR = odds ratio, PO = orally, QD = once a day.|12 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Percentage of responders|||Number
680458|NCT01569074|Secondary|Proportion of Patients With DAS28-CRP EULAR Response at Week 12, Comparison Between Fostamatinib and Placebo|Change from baseline in DAS28-CRP at Week 12 was derived and categorised using the European League Against Rheumatism (EULAR) response criteria. BID = twice a day, DMARD = disease-modifying anti-rheumatic drug, OR = odds ratio, PO = orally, QD = once a day.|12 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Percentage of responders|||Number
680459|NCT01569074|Secondary|Proportion of Patients Achieving DAS28-CRP<=3.2 at Week 12, Comparison Between Fostamatinib and Placebo|DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patient’s own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. DAS28-CRP score of <=3.2 indicates low disease activity. BID = twice daily, CRP = C-reactive protein, , DMARD = disease modifying anti-rheumatic drug, OR = odds ratio, PO = orally, QD = once daily.|12 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Percentage of responders|||Number
680460|NCT01569074|Secondary|ACRn - Comparison Between Fostamatinib and Placebo at Week 12|ACRn: American College of Rheumatology index of RA improvement, based on smallest percentage improvement in the count of swollen joints (out of 28 joints), count of tender joints (out of 28 joints), or in blood test measures of inflammation (such as C-Reactive Protein) or the physician or patient’s own assessments of disease activity, pain and physical function. Scores are reported as a percentage improvement on a scale of -100 to +100, with larger values representing a better clinical outcome. Mean refers to change at Week 12. BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once a day.|Baseline and 12 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Percentage improvement from baseline||Standard Deviation|Mean
680461|NCT01569074|Secondary|Proportion of Patients Achieving ACR70 at Week 12, Comparison Between Fostamatinib and Placebo|ACR70: American College of Rheumatology 70% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as C-Reactive Protein) and the physician and patient’s own assessments of disease activity, pain and physical function. BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once a day.|12 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Percentage of responders|||Number
680462|NCT01569074|Secondary|Proportion of Patients Achieving ACR50 at Week 12, Comparison Between Fostamatinib and Placebo|ACR50: American College of Rheumatology 50% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as C-Reactive Protein) and the physician and patient’s own assessments of disease activity, pain and physical function, BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once a day.|12 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Percentage of responders|||Number
680463|NCT01569074|Secondary|Proportion of Patients Achieving ACR20 at Week 1, Comparison Between Fostamatinib and Placebo|ACR20: American College of Rheumatology 20% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as C-Reactive Protein) and the physician and patient’s own assessments of disease activity, pain and physical function. BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, PO = orally.|1 week|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle. The fostamatinib 100 mg BID combined group contains 31 patients from Dosing Group A and 33 patients from Dosing Group B.||Percentage of responders|||Number
680599|NCT01566838|Primary|Number of Participants With and Without 30-Day Pain Medication Usage|The primary outcome will measure narcotics usage from post-operative day 1 through post-operative day 30.|Postoperative day 1 through postoperative day 30|30-day pain medication usage||participants|||Number
686483|NCT01489956|Primary|T Cell Stimulation Index (SI) as Measured by 3H-thymidine Incorporation After in Vitro KLH Stimulation of PBMC (Part A)|No data available for analyses|Day 9|Data were not collected and therefore no analyses could be performed.|||||
680464|NCT01569074|Primary|Proportion of Patients Achieving ACR20 at Week 12, Comparison Between Fostamatinib and Placebo|ACR20: American College of Rheumatology 20% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as C-Reactive Protein) and the physician and patient’s own assessments of disease activity, pain and physical function. BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once a day.|12 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Percentage of responders|||Number
680465|NCT01568905|Secondary|Comparison of Number of Cigarettes Smoked|Subjects were given a daily diary to collect the number of study and/or conventional cigarettes they have smoked each day. Cigarettes smoked (both usual brand and experimental) in a given week were summed over the first 7 reported days. If the number of cigarettes smoked was missing for 1 day, the average of the other days in that week was used in its place and reported as total number of cigarettes per week.|1 week|||cigarettes per week||Standard Deviation|Mean
680466|NCT01568905|Secondary|Change From Baseline of Perceived Health Risk Scale Response to Test Cigarettes|Questionnaire: Perceived Health Risk Scale asks subjects to rate their perception of health risks for lung cancer for the study product to which they have been randomly assigned. This is a 100 mm visual analog scale; 0=very low risk of disease, 100=very high risk of disease.|Baseline (Day 1) Compared to Second Visit (Week 1)|||units on a scale||Standard Error|Mean
680467|NCT01568905|Secondary|Responses on Modified Cigarette Evaluation Scale|Modified Cigarette Evaluation Scale [CES] is a 100 mm visual analog scale (0=not at all or very little nicotine; 100=extremely or high in nicotine) of 20 questions assessing different dimensions of responses to usual brand cigarettes (e.g., psychological reward, satisfaction and aversiveness) and includes additional 5 point likert-type questions (definitely agree to definitely disagree) on perceptions of satisfaction and willingness to use the product. Results satisfaction subscale.|Baseline usual brand cigarettes (Day 1) compared to when using study cigarettes (Week 1)|||units on a scale||Standard Error|Mean
680468|NCT01568905|Primary|Change in UrineTotal Nicotine Equivalent (TNE) Between Baseline and Week 1|Two urine TNE levels are taken, one at baseline and one at week 1, to assess TNE levels for nicotine exposure. TNE is the sum of nicotine, cotinine, trans 3'-hydroxycotinine and their respective glucuronide conjugates. Values reported in nmols/ml.|Second Visit (Week 1) minus Baseline (Day 1)|||nmols/ml||Standard Error|Mean
680469|NCT01568892|Secondary|Number of Participants With the Indicated Fold Increase in Fold Change (FC) in the 50% Inhibitory Concentration Relative to Wild-type Virus for DTG (i.e. PDVF FC/Baseline FC Ratio) at the Time of PDVF, as a Measure of Phenotypic Resistance|For participants meeting one of the criteria for PDVF, plasma samples collected at the time point of virologic failure were tested to evaluate any potential genotypic and/or phenotypic evolution of resistance. The FC in IC50 (50% inhibitory concentration) for DTG relative to wild-type virus was determined for virus isolated at Baseline and at the time of PDVF. The number of participants with the indicated change (ratio) in the two values at the time of PDVF is presented. PDVF was defined as (A) Virologic Non-response: a decrease in plasma HIV-1 RNA of <1 log10 copies/mL by Day 28, with subsequent confirmation, unless plasma HIV-1 RNA is <400 copies/mL; confirmed plasma HIV-1 RNA levels >=400 copies/mL on or after Week 24 or (B) Virologic Rebound: confirmed rebound in plasma HIV-1 RNA levels to >=400 copies/mL after prior confirmed suppression to <400 copies/mL; confirmed plasma HIV-1 RNA levels >1 log10 copies/mL above the nadir value, where nadir is >=400 copies/mL.|From the first dose of study medication until early withdrawal or through the Day 8 analysis data cut-off date (average of 96 study days)|PDVF Genotypic/Phenotypic Population: all participants in the ITT-E population with protocol-defined virologic failure. Only participants with Baseline integrase mutations with PDVF who had paired Baseline and time of PDVF samples were considered for analysis.||participants|||Number
680470|NCT01568892|Secondary|Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Defined Virologic Failure (PDVF), as a Measure of Genotypic Resistance|For participants meeting one of the criteria for PDVF, plasma samples collected at the time point of virologic failure were tested to evaluate any potential genotypic and/or phenotypic evolution of resistance. PDVF was defined as (A) Virologic Non-response: a decrease in plasma HIV-1 RNA of <1 log10 copies/mL by Day 28, with subsequent confirmation, unless plasma HIV-1 RNA is <400 copies/mL; confirmed plasma HIV-1 RNA levels >=400 copies/mL on or after Week 24 or (B) Virologic Rebound: confirmed rebound in plasma HIV-1 RNA levels to >=400 copies/mL after prior confirmed suppression to <400 copies/mL; confirmed plasma HIV-1 RNA levels >1 log10 copies/mL above the nadir value, where nadir is >=400 copies/mL.Treatment-emergent IN mutations are those detected at the time of PDVF but not at Baseline.|From the first dose of study medication until early withdrawal or through the Day 8 analysis data cut-off date (average of 96 study days)|PDVF Genotypic/Phenotypic Population: all participants in the ITT-E population with protocol-defined virologic failure. Only participants with Baseline integrase mutations with PDVF who had paired Baseline and time of PDVF samples were considered for analysis.||participants|||Number
680471|NCT01568892|Secondary|Plasma DTG Pre-dose Concentration (C0) at Day 8, Day 28, and Week 24; and Average DTG C0 (C0 Avg) at Week 24|Blood samples for the determination of plasma DTG pre-dose concentration were collected pre-dose on Day 8, Day 28, and Week 24. For Day 8 PK, only samples collected from participants randomized to the active DTG arm were analyzed. C0 Avg was calculated at Week 24 as the mean of the concentration at Day 8, Day 28, and Week 24|Day 8, Day 28, and Week 24|PK Parameter Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Parameter Population.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
680472|NCT01568892|Secondary|Cmax of DTG|The maximal concentration (Cmax) of DTG was assessed using a population PK modeling approach. Blood samples for the determination of plasma DTG concentration were collected at the following time points: pre-dose and 1-3 hours (hrs) post-dose on Day 8; pre-dose and within a post-dose window (1-3 hours or 4-12 hours) on Day 28 and Week 24. For Day 8 PK, only samples collected from participants randomized to the active DTG arm were analyzed. Results from these PK parameters will be reported separately.|Day 8, Day 28, and Week 24||12/2014||||
681914|NCT01547806|Primary|Average Number of Cluster of Differentiation 34 (CD34) Cells Collected (Per kg Recipient Body Weight (BW))|Progenitor cells by apheresis was determined by flow cytometry.|Through Day 2 of collection|||Number of CD34 cells per kg/BW (x 10EE6)||Standard Deviation|Mean
680473|NCT01568892|Secondary|AUC(0-tau) of DTG|The area under the time concentration curve over the dosing interval (AUC[0-tau]) of DTG was assessed using a population pharmacokinetic (PK) modeling approach. Blood samples for the determination of plasma DTG concentration were collected at the following time points: pre-dose and 1-3 hours (hrs) post-dose on Day 8; pre-dose and within a post-dose window (1-3 hours or 4-12 hours) on Day 28 and Week 24. For Day 8 PK, only samples collected from participants randomized to the active DTG arm were analyzed. Results from these PK parameters will be reported separately.|Day 8, Day 28, and Week 24||12/2014||||
680474|NCT01568892|Secondary|Number of Participants With the Maximum Post-Baseline-emergent Hematology Toxicities of the Indicated Grade|Participants with post-Baseline-emergent hematology toxicities were analyzed. Hematology toxicities were graded for severity according to the Division of AIDS (DAIDS) toxicity scales as: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), or Grade 4 (potentially life threatening).|From the first dose of study medication until early withdrawal or through the Day 8 analysis data cut-off date (average of 14 study weeks)|Safety Population||participants|||Number
680475|NCT01568892|Secondary|Number of Participants With the Maximum Post-Baseline-emergent Clinical Chemistry Toxicities of the Indicated Grade|Participants with post-Baseline-emergent clinical chemistry toxicities were analyzed. Clinical chemistry toxicities were graded for severity according to the Division of AIDS (DAIDS) toxicity scales as: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), or Grade 4 (potentially life threatening).|From the first dose of study medication until early withdrawal or through the Day 8 analysis data cut-off date (average of 14 study weeks)|Safety Population||participants|||Number
680476|NCT01568892|Secondary|Number of Participants With Any Adverse Event (Serious and Non-serious) of the Indicated Grade|An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity; or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in other situations. Adverse events were graded for severity according to the Division of AIDS (DAIDS) toxicity scales as: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), or Grade 4 (potentially life threatening).|From the first dose of study medication until early withdrawal or through the Day 8 analysis data cut-off date (average of 14 study weeks)|Safety Population: all randomized participants who received at least one dose of study medication||participants|||Number
680477|NCT01568892|Secondary|Number of Participants With the Indicated Type of HIV-1 Disease Progression (Acquired Immunodeficiency Syndrome [AIDS] or Death [DT])|The number of participants with HIV-1 disease progression (AIDS or death) was assessed per the Centers for Disease Control and Prevention (CDC) 1993 revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescents and adults. The CDC classifies HIV infection as Category A (participants with asymptomatic HIV infection, acute HIV infection with accompanying illness, or persistent generalized lymphadenopathy), Category B (participants with symptomatic non-AIDS condition, i.e., conditions that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or conditions are considered by physicians to have a clinical course or to require management that is complicated by HIV infection), and Category C (includes AIDS indicator conditions as defined by diagnostic or presumptive measures).|From the day of the first dose of study drug until early withdrawal or the Day 8 analysis cut-off date (average of 14 study weeks)|ITT-E Population||participants|||Number
680478|NCT01568892|Secondary|Median Change From Baseline in Cluster of Differentiation 8+ (CD8+) Cell Counts at Day 28|Blood samples were collected for lymphocyte subset assessment by flow cytometry at Baseline and Day 28. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.|Baseline and Day 28|ITT-E Population. The Observed Case dataset, in which only the data that are available at a particular time point are used, with no imputation for missing values, was used for analysis. Only those participants available at the specified time points were analyzed.||Cells per cubic millimeter||Inter-Quartile Range|Median
680479|NCT01568892|Secondary|Absolute Values in Cluster of Differentiation 8+ (CD8+) Cell Counts at Baseline and Day 28|Blood samples were collected for lymphocyte subset assessment by flow cytometry at Baseline and Day 28.|Baseline and Day 28|ITT-E Population. The Observed Case dataset, in which only the data that are available at a particular time point are used, with no imputation for missing values, was used for analysis. Only those participants available at the specified time points were analyzed.||Cells per cubic millimeter||Inter-Quartile Range|Median
680480|NCT01568892|Secondary|Median Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts Over Time|Blood samples were collected for lymphocyte subset assessment by flow cytometry at Baseline, Day 8, Day 28, and Week 8. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.|Baseline, Day 8, Day 28, and Week 8|ITT-E Population. The Observed Case dataset, in which only the data that are available at a particular time point are used, with no imputation for missing values, was used for analysis. Only those participants available at the specified time points were analyzed.||Cells per cubic millimeters||Inter-Quartile Range|Median
680481|NCT01568892|Secondary|Absolute Values in Cluster of Differentiation 4+ (CD4+) Cell Counts Over Time|Blood samples were collected for lymphocyte subset assessment by flow cytometry at Baseline, Day 8, Day 28, and Week 8.|Baseline, Day 8, Day 28, and Week 8|ITT-E Population. The Observed Case dataset, in which only the data that are available at a particular time point are used, with no imputation for missing values, was used for analysis. Only those participants available at the specified time points were analyzed.||Cells per cubic millimeters||Inter-Quartile Range|Median
680504|NCT01568112|Secondary|Duration of Acute GI Episodes During Weeks 5 to 8 (Combined), Based on MAGISS|Duration is calculated as follows: [(GI side effect) end date/time - (GI side effect) start date/time]/3600. For GI side effects with no end date, the end date is imputed using the last diary date/time. For subjects with more than 1 GI episode during a visit interval, the average duration for the study visit interval is used. The average duration is calculated as the total duration of the GI side effect / the total number of GI side effects.|Week 5 to Week 8|Participants in the safety population who have at least 1 diary entry of the relevant questionnaire data during the visit interval; n=number of participants with the given GI episode during the visit interval.||hours||Standard Deviation|Mean
686530|NCT01489189|Secondary|Number of Eyes With Vitreous Hemorrhage||2-years|||Eyes|Eyes||Number
680482|NCT01568892|Secondary|Number of Participants With Plasma HIV-1 RNA <400 c/mL Over Time|Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1), Day 8, Day 28, and Week 8, using the Food and Drug Administration's Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (VOI [due to missing data/discontinuation of investigational product prior to the visit window]) as nonresponders, as well as participants who switched their concomitant antiretroviral (ART) prior to the VOI as follows: background ART substitutions not permitted per protocol; background ART substitutions permitted per protocol, however the decision to switch was not documented as being before or at the first on-treatment visit after switching to optimized background regimen (i.e., Week 4) where HIV-1 RNA was assessed. Otherwise, virologic success/failure was to be determined by the last available HIV-1 RNA assessment while the participant was on treatment within the VOI analysis window.|Baseline, Day 8, Day 28, and Week 8|ITT-E Population. The Observed Case dataset, in which only the data that are available at a particular time point are used, with no imputation for missing values, was used for analysis. Only those participants available at the specified time points were analyzed.||participants|||Number
680483|NCT01568892|Secondary|Number of Participants With Plasma HIV-1 RNA <50 c/mL Over Time|Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1), Day 8, Day 28, and Week 8, using the Food and Drug Administration's Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (VOI [due to missing data/discontinuation of investigational product prior to the visit window]) as nonresponders, as well as participants who switched their concomitant antiretroviral (ART) prior to the VOI as follows: background ART substitutions not permitted per protocol; background ART substitutions permitted per protocol, however the decision to switch was not documented as being before or at the first on-treatment visit after switching to optimized background regimen (i.e., Week 4) where HIV-1 RNA was assessed. Otherwise, virologic success/failure was to be determined by the last available HIV-1 RNA assessment while the participant was on treatment within the VOI analysis window.|Baseline, Day 8, Day 28, and Week 8|ITT-E Population. The Observed Case dataset, in which only the data that are available at a particular time point are used, with no imputation for missing values, was used for analysis. Only those participants available at the specified time points were analyzed.||participants|||Number
680484|NCT01568892|Secondary|Mean Change From Baseline in Plasma HIV-1 RNA Over Time|Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1), Day 8, Day 28, Week 8, Week 12, Week 16, and Week 24. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. Too few participants reached post-Week 8 study visits, hence only data through Week 8 are presented.|Baseline, Day 8, Day 28, and Week 8|ITT-E Population. The Observed Case dataset, in which only the data that are available at a particular time point are used, with no imputation for missing values, was used for analysis. Only those participants available at the specified time points were analyzed.||Log10 c/mL||Standard Deviation|Mean
680485|NCT01568892|Secondary|Absolute Values in Plasma HIV-1 RNA Over Time|Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1), Day 8, Day 28, Week 8, Week 12, Week 16, and Week 24. Too few participants reached post-Week 8 study visits, hence only data through Week 8 are presented.|Baseline, Day 8, Day 28, and Week 8|ITT-E Population. The Observed Case dataset, in which only the data that are available at a particular time point are used, with no imputation for missing values, was used for analysis. Only those participants available at the specified time points were analyzed.||Log10 c/mL||Standard Deviation|Mean
680486|NCT01568892|Primary|Mean Change From Baseline in Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) at Day 8|Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1) and Day 8. Change from Baseline was calculated as the value at Day 8 minus the value at Baseline (Day 1). The analysis was performed using statistical modeling correcting for Baseline plasma HIV-1 RNA, Baseline Dolutegravir (DTG) fold change (FC), the overall susceptibility score (OSS) of the failing regimen, and the interaction between DTG FC and treatment. Means and differences were calculated using the average Baseline DTG FC of the entire Intent-to-Treat Exposed (ITT-E) Population. The last observation carried forward with discontinuation equals Baseline (LOCFDB) dataset was used for the analysis. For the LOCFDB dataset, missing values were carried forward from the previous, non-missing, available on-treatment assessment, except formissing values due to premature withdrawal or Day 8 missing values, which had the Baseline value imputed.|Baseline and Day 8|ITT-E Population: all randomized participants who received at least one dose of study medication. One participant receiving DTG 50 mg BID was excluded from analysis because they had no Baseline DTG FC value.||Log 10 copies per milliliter (c/mL)||Standard Error|Least Squares Mean
680487|NCT01568866|Secondary|Change From Baseline in Pulmonary Artery Systolic Pressure (PASP)|Pulmonary artery pressure was measured using transthoracic echocardiogram.|Baseline and Weeks 12, 24 and 36 and at end of treatment (median duration of treatment was 27 weeks in the bortezomib group and 40 weeks in the carfilzomib treatment group).|"Cardiopulmonary Safety Evaluable subgroup with available PASP data at baseline; n indicates participants whose results were available at both the baseline and the specified post-baseline visit."||mmHg||Standard Deviation|Mean
680488|NCT01568866|Secondary|Change From Baseline in Right Ventricular Fractional Area Change (FAC)|Right ventricular function was assessed by measuring fractional area change (FAC) on echocardiogram.|Baseline and Weeks 12, 24 and 36 and at end of treatment (median duration of treatment was 27 weeks in the bortezomib group and 40 weeks in the carfilzomib treatment group).|"Cardiopulmonary Safety Evaluable subgroup with available FAC data at baseline; n indicates participants whose results were available at both the baseline and the specified post-baseline visit."||percent fractional area change||Standard Deviation|Mean
680489|NCT01568866|Secondary|Percentage of Participants With a Significant Reduction in Left Ventricular Ejection Fraction (LVEF)|"A significant reduction in LVEF was defined as a ≥ 10% decrease (absolute change) from baseline in participants whose baseline LVEF is ≤ 55%.
For participants with LVEF > 55% at baseline, a significant change was defined as a decrease in LVEF to < 45%."|Baseline and 24 weeks|Cardiopulmonary Safety Evaluable subgroup (all randomized participants who enrolled in the cardiopulmonary substudy with evaluable baseline echocardiogram scans per the central laboratory) and with both baseline and at least one post-baseline LVEF measurement within 24 weeks.||percentage of participants|||Number
680552|NCT01567943|Secondary|Community Outcomes|(jail bookings, ER visits, mental health and substance abuse service utilization)|entire study period, and three month prior and after study involvement||||||
680553|NCT01567943|Secondary|Other Drug Use as Measured by Urinalysis||through 7 months of study||||||
680490|NCT01568866|Secondary|Percentage of Participants With ≥ Grade 2 Peripheral Neuropathy|"Neuropathy events were defined as Grade 2 or higher peripheral neuropathy as specified by peripheral neuropathy Standardised Medical Dictionary for Regulatory Activities (MedDRA) Query, narrow (scope) (SMQN) terms.
Peripheral neuropathy was assessed by neurologic exam and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03:
Grade 1: Asymptomatic; Grade 2: Moderate symptoms, limiting instrumental activities of daily living (ADL) Grade 3: Severe symptoms; limiting self-care ADL; Grade 4: Life-threatening consequences, urgent intervention indicated; Grade 5: Death."|From the first dose of study drug up to 30 days after the last dose of study drug as of the data cut-off date of 10 November 2014; median duration of treatment was 27 weeks in the bortezomib group and 40 weeks in the carfilzomib treatment group.|Safety population (all participants who received at least 1 dose of study treatment)||percentage of participants||95% Confidence Interval|Number
680491|NCT01568866|Secondary|Duration of Response|Duration of response (DOR) was calculated for participants who achieved an sCR, CR, VGPR, or PR. Duration of response is defined as the time from first evidence of PR or better to confirmation of disease progression or death due to any cause. Median duration of response was estimated using the Kaplan-Meier method. Participants with no baseline disease assessments, starting a new anticancer therapy before documentation of disease progression or death, death or disease progression immediately after more than 1 consecutively missed disease assessment visit, or alive without documentation of disease progression before the data cut-off date were censored.|From randomization until the data cut-off date of 10 November 2014; median follow-up time for DOR was 9.4 and 10.4 months for each treatment group respectively.|Intent-to-treat population with an overall response||months||95% Confidence Interval|Median
680492|NCT01568866|Secondary|Overall Response|"Disease response was evaluated according to the IMWG-URC by the IRC. Overall response was defined as the percentage of participants with a best overall response of partial response (PR), very good PR (VGPR), complete response (CR) or stringent CR (sCR).
sCR: As for CR, normal serum free light chain (SFLC) ratio and no clonal cells in bone marrow (BM).
CR: No immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and < 5% plasma cells in BM biopsy; VGPR: Serum and urine M-protein detectable by immunofixation but not electrophoresis or ≥ 90% reduction in serum M-protein with urine M-protein <100 mg/24 hours. A ≥ 50% reduction in the size of soft tissue plasmacytomas if present at baseline.
PR: ≥ 50% reduction of serum M-protein and reduction in urine M-protein by ≥ 90% or to < 200 mg/24 hours. A ≥ 50% reduction in the size of soft tissue plasmacytomas if present at baseline."|Disease response was assessed every 28 days until end of treatment or the data cut-off date of 10 November 2014; median duration of treatment was 27 weeks in the bortezomib group and 40 weeks in the carfilzomib treatment group.|Intent-to-treat population||percentage of participants||95% Confidence Interval|Number
680493|NCT01568866|Secondary|Overall Survival|"Overall survival (OS) is defined as the time from randomization to the date of death (whatever the cause). Participants who were alive or lost to follow-up as of the data analysis cut-off date were censored at the patient’s date of last contact (last known to be alive).
Median overall survival was estimated using the Kaplan-Meier method."|From randomization until the data cut-off date of 10 November 2014; median follow-up time for OS was 11.9 and 12.5 months for each treatment group respectively.|Intent-to-treat population||months||95% Confidence Interval|Median
680494|NCT01568866|Primary|Progression Free Survival|"Progression-free survival (PFS) was defined as the time from randomization to the earlier of disease progression or death due to any cause. Participants were evaluated for disease response and progression according to the International Myeloma Working Group-Uniform Response Criteria (IMWG-URC) as assessed by an Independent Review Committee (IRC).
Median PFS was estimated using the Kaplan-Meier method. Participants with no baseline disease assessments, starting a new anticancer therapy before documentation of disease progression or death, death or disease progression immediately after more than 1 consecutively missed disease assessment visit, or alive without documentation of disease progression before the data cut-off date were censored."|From randomization until the data cut-off date of 10 November 2014; median follow-up time for PFS was 11.1.and 11.9 months in the bortezomib and carfilzomib arms respectively|Intent-to-Treat Population||months||95% Confidence Interval|Median
680495|NCT01568827|Primary|Serum IL-6|Area Under the time-concentration Curve (AUC) of IL-6|acute (0-12 hours) after inflammation-causing challenge meal|||(pg*hr)/mL||95% Confidence Interval|Mean
680496|NCT01568593|Primary|Global Ocular Staining (With Oxford Scale - Ranges :0-15)|Change from baseline in the worse eye on Day 35 (decrease of Oxford score = better outcome)|Baseline and 35 days|Per Protocol Population||scores on a scale||Standard Deviation|Mean
680497|NCT01568424|Secondary|Total Bilirubin|Total bilirubin is a measure of hepatic function|Baseline, Day 1, Day 2, Day 3, Week 1, Prior to Explant, 1 day after RVAD removal, 2 days after RVAD removal, 30 days after RVAD removal|Patients with continuous RVAD support||mg/dl||Full Range|Median
680498|NCT01568424|Secondary|Creatinine|Creatinine is a measure of renal function|Baseline, Day 1, Day 2, Day 3, Week 1, Prior to Explant, 1 day after RVAD removal, 2 days after RVAD removal, 30 days after RVAD removal|Patients with continuous RVAD support||mg/dl||Full Range|Median
680499|NCT01568424|Secondary|Blood Urea Nitrogen (BUN)|BUN is a measure of renal function|Baseline, Day 1, Day 2, Day 3, Week 1, Prior to Explant, 1 day after RVAD removal, 2 days after RVAD removal, 30 days after RVAD removal|Patients with continuous RVAD support||mg/dl||Full Range|Median
680500|NCT01568424|Secondary|Cardiac Index (CI)|Cardiac output (L/min) divided by the body surface area (m2)|Baseline, Day 1, Day 2, Day 3, Week 1, Prior to Explant, 1 day after RVAD removal, 2 days after RVAD removal.|Patients with continuous RVAD support||L/min/m2||Full Range|Median
680501|NCT01568424|Secondary|Mean Arterial Pressure (MAP)|MAP is the mean value for the blood pressure in the arterial circulation. During RVAD support, this value provides information regarding the adequacy of cardiac output from the left ventricle.|Baseline, Day 1, Day 2, Day 3, Week 1, Prior to Explant, 1 day after RVAD removal, 2 days after RVAD removal.|Patients with continuous RVAD support.||mmHg||Full Range|Median
680502|NCT01568424|Secondary|Central Venous Pressure (CVP)|CVP is a measure of right heart filling pressure, or the preload to the right ventricle. During RVAD support, the CVP decreases as blood is drawn into the pump and then ejected into the pulmonary artery.|Baseline, Day 1, Day 2, Day 3, Week 1, Prior to Explant, 1 day after RVAD removal, 2 days after RVAD removal|Patients with continuous RVAD support.||mmHg||Full Range|Median
680554|NCT01567943|Secondary|Self Report Drug Use||through 7 months of study||||||
680505|NCT01568112|Secondary|Duration of Acute GI Episodes During Weeks 1 to 4 (Combined), Based on MAGISS|Duration is calculated as follows: [(GI side effect) end date/time - (GI side effect) start date/time]/3600. For GI side effects with no end date, the end date is imputed using the last diary date/time. For subjects with more than 1 GI episode during a visit interval, the average duration for the study visit interval is used. The average duration is calculated as the total duration of the GI side effect / the total number of GI side effects.|Week 1 to Week 4|Participants in the safety population who have at least 1 diary entry of the relevant questionnaire data during the visit interval; n=number of participants with the given GI episode during the visit interval.||hours||Standard Deviation|Mean
680506|NCT01568112|Secondary|Duration of Acute GI Episodes During the Overall Treatment Period, Based on MAGISS|Duration is calculated as follows: [(GI side effect) end date/time - (GI side effect) start date/time]/3600. For GI side effects with no end date, the end date is imputed using the last diary date/time. For subjects with more than 1 GI episode during a visit interval, the average duration for the study visit interval is used. The average duration is calculated as the total duration of the GI side effect / the total number of GI side effects.|Day 1 to Week 8|Participants in the safety population who have at least 1 diary entry of the relevant questionnaire data during the visit interval; n=number of participants with the given GI episode during the visit interval.||hours||Standard Deviation|Mean
680507|NCT01568112|Secondary|Duration of Flushing Events During the Weeks 5 to 8 (Combined), Based on MFSS|For participants with more than 1 flushing episode during a visit interval, the average duration for the visit interval was used. The average duration is calculated as: the total duration of all flushing episodes / the total number of flushing episodes.|Week 5 to Week 8|Participants with a flushing event.||minutes||Standard Deviation|Mean
680508|NCT01568112|Secondary|Duration of Flushing Events During the Weeks 1 to 4 (Combined), Based on MFSS|For participants with more than 1 flushing episode during a visit interval, the average duration for the visit interval was used. The average duration is calculated as: the total duration of all flushing episodes / the total number of flushing episodes.|Week 1 to Week 4|Participants with a flushing event.||minutes||Standard Deviation|Mean
680509|NCT01568112|Secondary|Duration of Flushing Events During the Overall Treatment Period, Based on MFSS|For participants with more than 1 flushing episode during a visit interval, the average duration for the visit interval was used. The average duration is calculated as: the total duration of all flushing episodes / the total number of flushing episodes.|Day 1 to Week 8|Participants with a flushing event.||minutes||Standard Deviation|Mean
680510|NCT01568112|Secondary|Number of Participants With Shifts From Baseline in Electrocardiogram (ECG) Results|Shift to 'abnormal, not adverse event' includes unknown or normal to 'abnormal, not adverse event.' Shift to 'abnormal, adverse event' includes unknown or normal to 'abnormal, adverse event.'|Day 1 to Week 8|Safety population: participants who received at least 1 dose of study treatment (BG00012/BG00012 placebo); n=number of participants whose baseline value was not abnormal and who had at least 1 post-baseline value.||participants|||Number
680511|NCT01568112|Secondary|Number of Participants With Abnormalities in Vital Signs|↑=increase; ↓=decrease; BL=baseline; bpm=beats per minute; SBP=systolic blood pressure; DBP=diastolic blood pressure; b/m=breaths per minute|Day 1 to Week 8|Safety population: participants who received at least 1 dose of study treatment (BG00012/BG00012 placebo); n=number of participants who had a baseline value and had at least 1 post-baseline value.||participants|||Number
680512|NCT01568112|Secondary|Clinical Laboratory Shifts From Baseline in Reported Values: Urinalysis|Number of participants with clinical laboratory shifts from baseline in urinalysis values.Shift to low includes normal to low, high to low, and unknown to low. Shift to high includes normal to high, low to high, and unknown to high. Shift to positive includes negative to positive and unknown to positive. RBC=red blood cells, WBC=white blood cells.|Day 1 to Week 8|Safety population: participants who received at least 1 dose of study treatment (BG00012/BG00012 placebo); n=number of participants whose baseline value was not low (or high or positive) and who had at least 1 post-baseline value.||participants|||Number
680513|NCT01568112|Secondary|Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry|Number of participants with clinical laboratory shifts from baseline in blood chemistry values. Shift to low includes normal to low, high to low, and unknown to low. Shift to high includes normal to high, low to high, and unknown to high. ALP=alkaline phosphatase, ALT=alanine aminotransferase, AST=aspartate aminotransferase, GGT=gamma-glutamyl transferase, LDH=lactate dehydrogenase, BUN=blood urea nitrogen.|Day 1 to Week 8|Safety population: participants who received at least 1 dose of study treatment (BG00012/BG00012 placebo); n=number of participants whose baseline value was not low (or high) and who had at least 1 post-baseline value.||participants|||Number
680514|NCT01568112|Secondary|Clinical Laboratory Shifts From Baseline in Reported Values: Hematology|Number of participants with clinical laboratory shifts from baseline in hematology values. Shift to low includes normal to low, high to low, and unknown to low. Shift to high includes normal to high, low to high, and unknown to high. abs=absolute|Day 1 to Week 8|Safety population: participants who received at least 1 dose of study treatment (BG00012/BG00012 placebo); n=number of participants whose baseline value was not low (or high) and who had at least 1 post-baseline value.||participants|||Number
680515|NCT01568112|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious AEs (SAEs)|AE: any untoward medical occurrence that does not necessarily have a causal relationship with treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the subject at immediate risk of death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigator, may jeopardize the subject or may require intervention to prevent one of the other outcomes. An AE was considered treatment-emergent if it occurred after the start of study treatment or was present prior to the start of study treatment but subsequently worsened.|Day 1 up to end of Safety Follow-up (9 weeks)|Safety population: participants who received at least 1 dose of study treatment (BG00012/BG00012 placebo).||participants|||Number
680555|NCT01567943|Secondary|Change in Intensive Outpatient Substance Abuse Treatment Attendance||During 16 weeks of treatment|||percentage of addiction tx attended||Standard Deviation|Mean
681915|NCT01547806|Primary|Percentage of Patients Requiring 2 Days to Achieve at Least 2 x 10^6 Cluster of Differentiation 34 (CD34) Cells Per Kg Recipient Body Weight|Progenitor cells by apheresis was determined by flow cytometry.|Through Day 2 of collection|||percentage of patients|||Number
680516|NCT01568112|Primary|Percentage of Participants Reporting GI Events During Weeks 5 to 8 (Combined), as Assessed by the Modified Overall Gastrointestinal Symptom Scale (MOGISS)|The MOGISS is a questionnaire about overall side effects related to the gastrointestinal system (including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, and flatulence) during the 24 hours prior to each AM dose. Participants were to answer the questions at the same time each day, before the morning drug administration.|Week 5 to Week 8|Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.||percentage of participants|||Number
680517|NCT01568112|Primary|Percentage of Participants Reporting GI Events During Weeks 1 to 4 (Combined), as Assessed by the Modified Overall Gastrointestinal Symptom Scale (MOGISS)|The MOGISS is a questionnaire about overall side effects related to the gastrointestinal system (including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, and flatulence) during the 24 hours prior to each AM dose. Participants were to answer the questions at the same time each day, before the morning drug administration.|Week 1 to Week 4|Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.||percentage of participants|||Number
680518|NCT01568112|Primary|Percentage of Participants Reporting GI Events During the Overall Treatment Period, as Assessed by the Modified Overall Gastrointestinal Symptom Scale (MOGISS)|The MOGISS is a questionnaire about overall side effects related to the gastrointestinal system (including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, and flatulence) during the 24 hours prior to each AM dose. Participants were to answer the questions at the same time each day, before the morning drug administration.|Day 1 to Week 8|Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.||percentage of participants|||Number
680519|NCT01568112|Primary|Worst Severity Scores of Acute GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS|Severity of GI-related events using the MAGISS to measure GI symptoms (nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, flatulence), based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms.|Week 5 to Week 8|Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.||units on a scale||Standard Deviation|Mean
680520|NCT01568112|Primary|Worst Severity Scores of Acute GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS|Severity of GI-related events using the MAGISS to measure GI symptoms (nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, flatulence), based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms.|Day 1 to Week 4|Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.||units on a scale||Standard Deviation|Mean
680521|NCT01568112|Primary|Percentage of Participants Reporting GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS|The MAGISS is a participant-reported questionnaire about side effects of the gastrointestinal system following drug administration, and is based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms. A participant was considered having overall GI side effect if he/she had a score of >=1 for at least one of the GI side effects including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating and flatulence.|Week 5 to Week 8|Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.||percentage of participants|||Number
680522|NCT01568112|Primary|Percentage of Participants Reporting GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS|The MAGISS is a participant-reported questionnaire about side effects of the gastrointestinal system following drug administration, and is based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms. A participant was considered having overall GI side effect if he/she had a score of >=1 for at least one of the GI side effects including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating and flatulence.|Day 1 to Week 4|Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.||percentage of participants|||Number
680523|NCT01568112|Primary|Percentage of Participants Reporting Gastrointestinal (GI) Events During the Overall Treatment Period, as Assessed by the Modified Acute Gastrointestinal Scale (MAGISS)|The MAGISS is a participant-reported questionnaire about side effects of the gastrointestinal system following drug administration, and is based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms. A participant was considered having overall GI side effect if he/she had a score of >=1 for at least one of the GI side effects including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating and flatulence.|Day 1 to Week 8|Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.||percentage of participants|||Number
680524|NCT01568112|Primary|Percentage of Participants Reporting Overall Flushing Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MGFSS|Participant-reported flushing events during Weeks 5 to 8 of treatment (combined), recorded on the hand-held participant reporting device (eDiary) as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). Day 1 data are not included in the analysis because MGFSS question refers to last 24 hours flushing score.|Week 5 to Week 8|Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.||percentage of participants|||Number
680556|NCT01567943|Primary|Alcohol Use as Assessed by Ethyl Glucuronide Detection in Urine|Mean EtG value (in ng/mL). 150ng/mL or above = EtG-positive, 149ng/mL or below = EtG-negative. EtG = ethyl glucuronide, alcohol biomarker detectable in urine.|Over 16 weeks of treatment (repeated measure)|||EtG Value (nanograms per milileter)||Standard Error|Mean
680525|NCT01568112|Primary|Percentage of Participants Reporting Overall Flushing Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MGFSS|Participant-reported flushing events during Weeks 1 to 4 of treatment (combined), recorded on the hand-held participant reporting device (eDiary) as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). Day 1 data are not included in the analysis because MGFSS question refers to events reported in the 24 hours after the first dose on Day 1.|Day 2 to Week 4|Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.||percentage of participants|||Number
680526|NCT01568112|Primary|Percentage of Participants Reporting Overall Flushing Events During the Overall Treatment Period, as Assessed by the Modified Global Flushing Severity Scale (MGFSS)|Participant-reported flushing events during the overall treatment period, recorded on the hand-held participant reporting device (eDiary) as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). Day 1 data are not included in the analysis because MGFSS question refers to events reported in the 24 hours after the first dose on Day 1.|Day 2 to Week 8|Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.||percentage of participants|||Number
680527|NCT01568112|Primary|Worst Severity Scores of Overall Flushing During Weeks 5 to 8 of Treatment (Combined), as Assessed by MFSS|Worst severity of participant-reported flushing events during Weeks 1-4 of treatment combined, recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin.This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).|Week 5 to Week 8|Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.||units on a scale||Standard Deviation|Mean
680528|NCT01568112|Primary|Worst Severity Scores of Overall Flushing During Weeks 1 to 4 of Treatment (Combined), as Assessed by MFSS|Worst severity of participant-reported flushing events during Weeks 1-4 of treatment combined, recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).|Day 1 to Week 4|Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.||units on a scale||Standard Deviation|Mean
680529|NCT01568112|Primary|Percentage of Participants Reporting Overall Flushing Events During Weeks 5 to 8 (Combined), as Assessed by MFSS|Participant-reported flushing side effect events during Weeks 1 to 4 recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).|Week 5 to Week 8|Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.||percentage of participants|||Number
680530|NCT01568112|Primary|Percentage of Participants Reporting Overall Flushing Events During Weeks 1 to 4 (Combined), as Assessed by MFSS|Participant-reported flushing side effect events during Weeks 1 to 4 recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).|Week 1 to Week 4|Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.||percentage of participants|||Number
680531|NCT01568112|Primary|Percentage of Participants Reporting Overall Flushing Events During the Overall Treatment Period, as Assessed by the Modified Flushing Severity Scale (MFSS)|Participant-reported flushing side effect events during the treatment period recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).|Day 1 to Week 8|Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.||percentage of participants|||Number
680532|NCT01568073|Secondary|Non-motor Symptoms Scale (NMSS)|"The Non-motor Symptoms Scale (NMSS) consists of 30 questions, covering 9 dimensions, whereby each item is scored for severity and frequency: Severity None 0 Mild (symptoms present but causes little distress) 1 Moderate (some distress or disturbance to subject) 2 Severe (major source of distress or disturbance to subject) 3
Frequency Rarely (<1/wk) 1 Often (1/wk) 2 Frequent (several times per week) 3 Very Frequent (daily or all the time) 4
The product of frequency and severity is calculated for each item and each dimension score is defined as the sum of the frequency*severity of the respective items. If frequency or severity of a single item is missing, the domain score will not be calculated. The NMSS total score is defined as the sum of all domain scores.
The NMSS total score is calculated by adding all domain scores (0–360), and lower scores mean less disability."|14 to 15 weeks|||units on a scale||Standard Deviation|Mean
680533|NCT01568073|Secondary|Parkinson's Disease Sleep Scale (PDSS)|"The Parkinson’s disease Sleep Scale (PDSS) is a specific scale for the assessment of sleep disturbances in subjects with PD. The PDSS score is calculated as the sum of all single items. If one or two items are missing, they will be imputed with the mean of the non-missing items. If three or more items are missing, no imputation will be done and the score will be set to missing.
Subscale has 0-10 ratings, where 0 = severe and 10 = normal
The PDSS total score is a sum score of all 15 questions and ranges from 0 to 150, with lower scores meaning more disability."|14 to 15 weeks|||units on a scale||Standard Deviation|Mean
680534|NCT01568073|Secondary|Total UPDRS SCORE (I, II (ON), and III)|"Total UPDRS (Part I, II (ON) and III)
UPDRS I evaluation of mentation, behavior, and mood
UPDRS II self-evaluation of the activities of daily life (ADLs) including speech, swallowing, handwriting, dressing, hygiene, falling, salivating, turning in bed, walking, and cutting food
UPDRS III clinician-scored monitored motor evaluation The UPDRS I, II and III scores and subscores are calculated as the sum of all individual items. If one or two items in a scale are missing, they will be imputed with the mean of the non-missing items of that scale.
Subscale has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe
The final cumulative score will range from 0 (no disability) to 199 (total disability)."|14 to 15 weeks|||units on a scale||Standard Deviation|Mean
680535|NCT01568073|Primary|Efficacy of 3 BIA 9-1067 (5 mg, 25 mg, and 50 mg) Compared With 200 mg of Entacapone or Placebo,|The primary efficacy variable will be the change from baseline in absolute OFF-time at the end of the DB period, This results refers when administered with the existing treatment of L-DOPA plus a DDCI, in patients with PD and end-of-dose motor fluctuations|14 to 15 weeks|||minutes||Standard Error|Mean
680536|NCT01568047|Primary|Tmax - Time to Observed Maximum Concentration|"Baseline period - to be switched respectively to standard-release levodopa/carbidopa 100/25 mg (Sinemet®) or levodopa/benserazide 100/25 mg (Madopar®/Restex®) and to adjust the number of daily doses.
Test Period - After the baseline period during the 21 to 28 days"|28 days|||ng/mL||Full Range|Median
680537|NCT01568047|Secondary|AUC0-6 - Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to to 6 h Postdose (AUC [0-6])|"Baseline period - to be switched respectively to standard-release levodopa/carbidopa 100/25 mg (Sinemet®) or levodopa/benserazide 100/25 mg (Madopar®/Restex®) and to adjust the number of daily doses.
Test Period - After the baseline period during the 21 to 28 days"|28 days|||ng.h/mL||Standard Deviation|Mean
680538|NCT01568047|Primary|Cmax - Observed Maximum Concentration|"Baseline period - to be switched respectively to standard-release levodopa/carbidopa 100/25 mg (Sinemet®) or levodopa/benserazide 100/25 mg (Madopar®/Restex®) and to adjust the number of daily doses.
Test Period - After the baseline period during the 21 to 28 days"|28 days|||ng/mL||Standard Deviation|Mean
680539|NCT01568034|Primary|Tmax = Time to Cmax Day 3|tmax = time to Cmax (values are median)|Day 3|||hours||Full Range|Median
680540|NCT01568034|Secondary|AUC0-6 - Area Under the Plasma Concentration-time Curve From Time 0 to 6 Hours Post-dose (Day 3)|AUC0-6 - area under the plasma concentration-time curve from time 0 to 6 hours post-dose (ng.h/mL)|Day 3|||ng.h/mL||Standard Deviation|Mean
680541|NCT01568034|Primary|Cmax - Maximum Plasma Concentration Day 3|Cmax - Maximum plasma concentration (ng/mL)|Day 3|||ng/ml||Standard Deviation|Mean
680542|NCT01568021|Secondary|Change From Baseline in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT)|Central Retinal Thickness was measured in the study eye using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina to assess retinal thickness. A negative change indicated an improvement.|Baseline, Weeks 12, 24 and 48|All participants with complete data at the given time-point.||microns||Standard Deviation|Mean
680543|NCT01568021|Secondary|Change From Baseline in Best Corrected Visual Acuity (BCVA) Score|BCVA was measured in the study eye using an eye chart and was reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number improvement in the number of letters read means that the vision improved.|Baseline, Weeks 12, 24 and 48|All participants with complete data at the given time-point.||letters||Standard Deviation|Mean
680544|NCT01568021|Primary|Time to First Re-treatment|Time to first re-treatment was defined as the time in days between the first administration of Ozurdex® and the following administration of Ozurdex® (re-treatment) in the study eye.|1 Year|All Participants with complete data.||days||95% Confidence Interval|Median
680545|NCT01568008|Primary|Intraocular Pressure (IOP) at Week 12|IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left eye and the right eye at Week 12. The lower the IOP values the greater the improvement.|Week 12|All patients with complete data available for IOP.||mm Hg||Standard Deviation|Mean
680546|NCT01568008|Primary|Intraocular Pressure (IOP) at Baseline|IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eye at Baseline.|Baseline|All patients with complete data available for IOP.||mm Hg||Standard Deviation|Mean
680547|NCT01568008|Secondary|Number of Patients Continuing Treatment After 12 Weeks|The number of patients continuing treatment after 12 weeks was determined by the physician answering yes to the question: Is the patient continuing on Lumigan® 0.01% treatment?|12 weeks|All patients with data available for this outcome measure.||Participants|||Number
680548|NCT01568008|Secondary|Physician Reported Reasons for Treatment Discontinuation|The number of patients who discontinued from treatment by category is reported. More than one reason may apply to each patient.|12 weeks|All patients with data available for this outcome measure.||Participants|||Number
680549|NCT01568008|Secondary|Physician Assessment of Treatment Tolerability Using a 4-Point Scale|The Physician evaluated the patient's tolerability of treatment using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed in each of the categories is reported.|12 weeks|All patients with data available for this outcome measure.||Participants|||Number
680550|NCT01568008|Secondary|Patient Assessment of Treatment Tolerability Using a 4-Point Scale|Patients evaluated their tolerability of treatment using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed in each of the categories is reported.|12 weeks|All patients with data available for this outcome measure.||Participants|||Number
680551|NCT01567943|Secondary|Psychiatric Symptomology|Brief Symptom Inventory; Positive and Negative Symptom Scale|throughout 7 months of study||||||
680558|NCT01567852|Primary|Re-orientation Time|Patients will be scored based on 5 questions (name, age, year, day of week, location). Each patient will be scored prior to induction as to how many questions they score correctly. Patient is deemed re-oriented when they score the same as baseline after the treatment.|1 hour|Since this was a crossover study, all patients received both drugs, except for 2 patients who dropped out after receiving the first drug. For one of these patients the drug was ketamine, for the other the drug was methohexital. Number of total trials analyzed was 69, with 35 Ketamine trials and 34 Methohexital trials||minutes||Standard Deviation|Mean
680559|NCT01567839|Primary|Successful Pulpal Anesthesia.|Two consecutive 80/80 readings (no patient response) during 60 minutes of testing with an electric pulp tester.|60 minutes|||participants|||Number
680560|NCT01567826|Secondary|Blood Chemistry - HsCRP|Correlation of yellow plaque index with changes in levels of blood HsCRP as compared from baseline to 6-8 weeks after intervention|at baseline and at 6-8 weeks after intervention|||mg/l||Inter-Quartile Range|Median
680561|NCT01567826|Secondary|Major Adverse Cardiac Events (MACE)|MACE defined as a combined clinical endpoint of death, MI (Q wave or non Q-wave with CK-MB >3 times above the upper normal limit (48 U/L), urgent revascularization or stroke at 30 days and 1 year. Details reported in adverse events section.|at 6-8 weeks after intervention|||participants|||Number
680562|NCT01567826|Secondary|Post PCI Cardiac Enzymes|Correlation of yellow plaque index with post procedure CK-MB, Troponin-I release.|at 6-8 weeks after intervention|||ng/mL||Standard Deviation|Mean
680563|NCT01567826|Secondary|Diameter Stenosis|Percentage stenosis of vessel diameter in the analysis segment of nontarget lesions as measured by angiography that remained >70%, after successful PCI of the target lesion.|Baseline and 6-8 weeks post intervention|||percentage of lesions|||Number
680564|NCT01567826|Secondary|Fractional Flow Reserve (FFR) Value|Change in FFR as related to change in yellow plaque index as compared from baseline to 6-8 weeks after intervention. Fractional flow reserve (FFR), defined as the ratio of maximum flow in the presence of a stenosis to normal maximum flow, is a lesion-specific index of stenosis severity that can be calculated by simultaneous measurement of mean arterial, distal coronary, and central venous pressure.|at baseline and at 6-8 weeks after intervention|||ratio||Standard Deviation|Mean
680565|NCT01567826|Secondary|Intravascular Ultrasound (IVUS) Parameters|"Change in atheroma volume and lumen CSA on IVUS as related to change in yellow plaque index as compared from baseline to 6-8 weeks after intervention.
Data not analyzed. Data not available."|at baseline and at 6-8 weeks after intervention|||mm^2||Standard Deviation|Mean
680566|NCT01567826|Primary|Change in LCBI, Lesion|Change in LCBI at 6-8 weeks after intervention as compared to baseline|at baseline and at 6-8 weeks post intervention|Data were not available in 17 patients because of loss to follow-up (n = 5), incorrect image formatting that could not be recovered at the time of core laboratory analysis (n = 5), NIRS console/catheter malfunction at the time of index PCI (n = 3), and loss of disc integrity or corruption before core laboratory analysis (n = 4).||ratio||95% Confidence Interval|Median
680567|NCT01567826|Primary|Change in LCBI4mm Max|Change in LCBI4mm max at 6-8 weeks after intervention as compared to baseline. LCBI4mm max = change in lipid-core burden index at the 4-mm maximal segment.|at baseline and at 6-8 weeks after intervention|Data were not available in 17 patients because of loss to follow-up (n = 5), incorrect image formatting that could not be recovered at the time of core laboratory analysis (n = 5), NIRS console/catheter malfunction at the time of index PCI (n = 3), and loss of disc integrity or corruption before core laboratory analysis (n = 4).||ratio||95% Confidence Interval|Median
680568|NCT01567826|Primary|LCBI4mm Max|LCBI4mm max = change in lipid-core burden index at the 4-mm maximal segment. Spectroscopic information obtained from raw spectra was transformed into a probability of lipid core that was mapped to a red-to-yellow color scale, with the low probability of lipid shown as red and the high probability of lipid shown as yellow. Yellow pixels within the analyzed segment were divided by all viable pixels to generate the lipid-core burden index (LCBI). The maximal value of LCBI for each nonculprit obstructive lesion was recorded and used for comparison.|at baseline and at 6-8 weeks after intervention|Data were not available in 17 patients because of loss to follow-up (n = 5), incorrect image formatting that could not be recovered at the time of core laboratory analysis (n = 5), NIRS console/catheter malfunction at the time of index PCI (n = 3), and loss of disc integrity or corruption before core laboratory analysis (n = 4).||ratio||Inter-Quartile Range|Median
680569|NCT01567826|Primary|Lipiscan - Lipid Core Burden Index (LCBI)|The regression of yellow plaque content from the atherosclerotic lipid pool after statin therapy by utilizing NIR spectroscopy as compared from baseline to 6-8 weeks after intervention. Spectroscopic information obtained from raw spectra was transformed into a probability of lipid core that was mapped to a red-to-yellow color scale, with the low probability of lipid shown as red and the high probability of lipid shown as yellow. Analyses were performed offline using the Matlab-based software, as previously published. Yellow pixels within the analyzed segment were divided by all viable pixels to generate the lipid-core burden index (LCBI). The maximal value of LCBI for each nonculprit obstructive lesion was recorded and used for comparison.|at baseline and at 6-8 weeks after intervention|Data were not available in 17 patients because of loss to follow-up (n = 5), incorrect image formatting that could not be recovered at the time of core laboratory analysis (n = 5), NIRS console/catheter malfunction at the time of index PCI (n = 3), and loss of disc integrity or corruption before core laboratory analysis (n = 4).||ratio||Inter-Quartile Range|Median
680570|NCT01567371|Secondary|Difference in Stroke Volume Variability From Baseline to Post ANH.|The difference in stroke volume variability during a period of phlebotomy and graded blood loss, measured before phlebotomy or acute normovolemic hemodilution (ANH) and immediately after.|1 Day|||% variability||Standard Deviation|Mean
680571|NCT01567371|Primary|Difference in Pulse Pressure Variability From Baseline to Post-ANH|The difference in pulse pressure variability during a period of phlebotomy and graded blood loss, measured before phlebotomy or acute normovolemic hemodilution (ANH) and immediately after.|1 Day|||% variability||Standard Deviation|Mean
680572|NCT01567163|Secondary|Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of Ramucirumab in the Presence of Docetaxel||Cycle 2: 1 hour prior to ramucirumab infusion, 0, 1, 2, 2.5, 3, 4, 6, 8, 25, 49, 73, 169, 265 and 337 hours post ramucirumab infusion|All enrolled participants who received ramucirumab and had sufficient concentration data to calculate ramucirumab Cmax in Cycle 2.||micrograms/milliliter (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
680574|NCT01567163|Secondary|Number of Participants With Treatment-Emergent Anti-Ramucirumab Antibodies|Participants with treatment-emergent anti-ramucirumab antibodies were participants with a 4-fold increase (2 dilution increase) in immunogenicity titer over baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20).|Cycle 1, Day 1 through Cycle 2, Day 1 and 30 days after last dose of study drug|All participants who completed Cycle 1, Day 1 and Cycle 2, Day 1 treatment who had immunogenicity samples collected at the specified time points.||participants|||Number
680575|NCT01567163|Primary|Pharmacokinetics: Dose-Normalized Maximum Observed Drug Concentration (Cmax) of Docetaxel in Cycle 2||Cycle 2: 0, 1, 1.5, 2, 3, 5, 7, 24, 48 and 72 hours post docetaxel infusion|All participants who completed Cycle 1, Day 1 and Cycle 2, Day 1 treatment and had sufficient concentration data to calculate docetaxel Cmax in Cycle 2.||nanograms/milliliter/milligram||Geometric Coefficient of Variation|Geometric Mean
680576|NCT01567163|Primary|Pharmacokinetics: Dose-Normalized Maximum Observed Drug Concentration (Cmax) of Docetaxel in Cycle 1||Cycle 1: 0, 1, 1.5, 2, 3, 5, 7, 24, 48, and 72 hours post docetaxel infusion|All participants who completed Cycle 1, Day 1 and Cycle 2, Day 1 treatment and had sufficient concentration data to calculate docetaxel Cmax in Cycle 1.||nanograms/milliliter/milligram||Geometric Coefficient of Variation|Geometric Mean
680577|NCT01567163|Primary|Pharmacokinetics: Dose-Normalized Area Under the Concentration Versus Time Curve of Docetaxel From Time Zero to Infinity [AUC(0-∞)] Following a Single Dose in Cycle 2||Cycle 2: 0, 1, 1.5, 2, 3, 5, 7, 24, 48 and 72 hours post docetaxel infusion|All participants who completed Cycle 1, Day 1 and Cycle 2, Day 1 treatment and had sufficient concentration data to calculate docetaxel AUC(0-∞) in Cycle 2.||nanograms*hour/milliliter/milligram||Geometric Coefficient of Variation|Geometric Mean
680578|NCT01567163|Primary|Pharmacokinetics: Dose-Normalized Area Under the Concentration Versus Time Curve of Docetaxel From Time Zero to Infinity [AUC(0-∞)] Following a Single Dose in Cycle 1||Cycle 1: 0, 1, 1.5, 2, 3, 5, 7, 24, 48 and 72 hours post docetaxel infusion|All participants who completed Cycle 1, Day 1 and Cycle 2, Day 1 treatment and had sufficient concentration data to calculate docetaxel AUC(0-∞) in Cycle 1.||nanograms*hour/milliliter/milligram||Geometric Coefficient of Variation|Geometric Mean
680579|NCT01567150|Secondary|Wound Healing|change in wound area mean was calculated for each subject Mean and sd were calculated for each group|12 weeks|average across 12 week time frame||square cm||Standard Deviation|Mean
680580|NCT01567150|Primary|Matrix Metalloproteinase Level in Wound Fluid|"Wound fluid will be collected and analyzed at baseline and approximately every 7 days.
Mean was calculated for each subject. Means and standard deviation were calculated for the treatment and control groups."|8 weeks|Overall mean across 8 week timeframe||mcg/ml||Standard Deviation|Mean
680581|NCT01567020|Secondary|Number of Participants With Decreased Amplitudes or Increased Latencies in Electrophysiological Tests of Central Auditory Function|"Tests to be administered:
Auditory Brainstem Response Long Latency Response"|six months||||||
680582|NCT01567020|Secondary|Functional Hearing Ability in Multitalker Environments||six months||||||
680583|NCT01567020|Secondary|Comprehensive Audiological Examination||six months||||||
680584|NCT01567020|Secondary|Number of Participants With Abnormal Ratings of Self-reported Ability to Process Auditory Information in Various Settings|"Questionnaires to be administered:
Hearing Health Inventory Speech, Spatial, and Qualities of Hearing"|six months||||||
680585|NCT01567020|Primary|Number of Blast-exposed Veterans With Abnormal Abilities in One or More Behavioral Tests of Central Auditory Processing|"Tests to be administered:
Dichotic Digits Test: Percentage of digits reported correctly from 0 (worst performance) to 100 (best performance) Gaps in Noise Test: Approximate threshold in milliseconds from 2 (best) to 20 (worst) Staggered Spondaic Words Test: Total number of errors from 0 (best) to 40 (worst) Masking Level Differences Test: Difference in threshold between diotic and dichotic stimuli in decibels from 0 (worst) to 24 (best) Frequency Pattern Test: Percentage of sequences reported correctly from 0 (worst performance) to 100 (best performance) Adaptive Tests of Temporal Resolution: Not reported due to software error in stimulus presentation"|six months|Note that some of the participants finished all of the primary outcome measures but withdrew without finishing all of the secondary tests. They are thus listed as having withdrawn but are still included here for completeness.||units on a scale||Standard Deviation|Mean
680586|NCT01566981|Secondary|Change of the Following Parameter : HbA1C||baseline and six months||||||
680587|NCT01566981|Secondary|Change of Blood Lipid Level ( Low Density Cholesterol)||baseline and six months||||||
680588|NCT01566981|Secondary|Change of Patients' Functional Health Status Via WONCA-COOP Questionnaire.||baseline and one year||11/2013||||
680589|NCT01566981|Secondary|Quality of Patients' Life Via WONCA-COOP Questionnaire.||baseline and one year||||||
680590|NCT01566981|Secondary|Change of Blood Lipid Level ( Low Density Cholesterol)||baseline and one year||||||
680591|NCT01566981|Secondary|Patients' Functional Health Status Via WONCA-COOP Questionnaire.|WONCA COOP questionnaire measure seven core aspects of functional status, therefore this instrument consists of 7 five-point ordinal sub-scales. Each scale ranging from 1 (‘no limitation at all’) to 5 (‘severely limited’); for ‘change in health’ score 1 means ‘much better’ and score 5‘much worse’. Sub-scales are averaged to compute a total score.|one year|||units on a scale||Standard Deviation|Mean
680592|NCT01566981|Secondary|Body Mass Index at 1 Year||one year|||Kg/m2||Standard Deviation|Mean
680593|NCT01566981|Primary|Change From Baseline in HbA1C at 1 Year.||1 year|||percentage of glycated haemoglobin||Standard Deviation|Mean
680594|NCT01566838|Secondary|Resumed Physical Activity|Did the patient resume physical activity.|30 days|Resuming of physical activity||participants|||Number
680595|NCT01566838|Secondary|Return to Work|Returned to work in 30 days?|30 days|30 day return to work||participants|||Number
680596|NCT01566838|Secondary|30-day Incidence of Parasthesia|30-day incidence of paresthesia (tingling or pricking sensation, usually caused by pressure or nerve damage)|30 days|30-day incidence of paresthesia||participants|||Number
680597|NCT01566838|Secondary|Length of Stay|Hospital length of stay for this operation will be recorded and analyzed for each arm of the study.|Participants will be followed for the duration of hospital stay, an expected average of 5 days|In-hospital length of stay (days)||days||Inter-Quartile Range|Median
680598|NCT01566838|Secondary|7-day Paresthesia|Participants experiencing parasthesia (a tingling or pricking sensation usually caused by pressure or damage to nerves) through postoperative day 7|Postoperative day 1 through day 7|7-day paresthesia||participants|||Number
680600|NCT01566721|Secondary|Percentage of Participants by Item Response to SID Satisfaction Questionnaire|"The SID satisfaction questionnaire was administered twice during the study and asked participants to respond to five statements using a Likert scale from Strongly Disagree to Strongly Agree. Questionnaire items were as follows: I felt comfortable injecting the study drug by myself (Comfortable), The SID was convenient and easy to use (Easy to Use), I am confident giving myself an injection in the thigh with the SID (Confident), Taking all things into account I find self-administration using the SID satisfactory (Satisfactory), If given the opportunity I would choose to continue self-injecting the study drug using the SID in the future (Continue). Participants could only select one response per questionnaire item. There was no calculation of any score, but rather, descriptive summaries were generated by item response. The percentage of participants was reported by the response given for each item on the SID satisfaction questionnaire."|Cycle 4 (cycle length 3 weeks) and last safety follow-up (LSFU) (approximately 1 year)|Safety Population. Only participants who performed self-administration were included. The number of participants who responded to the questionnaire item at each assessment (n) is shown in the table.||percentage of participants|||Number
680601|NCT01566721|Secondary|Overall Survival (OS)|OS is defined as the time from first dose of SC Herceptin to death from any cause.|From Baseline to time of event (up to approximately 8 years)||2020||||
680602|NCT01566721|Secondary|Percentage of Participants Who Died by Data Cutoff of 10 March 2015|The percentage of participants who died from any cause was reported.|From Baseline to time of event (maximum follow-up approximately 3 years as of data cutoff of 10 March 2015)|ITT Population||percentage of participants|||Number
680603|NCT01566721|Secondary|Disease-Free Survival (DFS)|DFS is defined as the time from first dose of SC Herceptin to the first event of local, regional or distant recurrence, contralateral invasive breast cancer (including ipsilateral ductal carcinoma in situ) or death due to any cause.|From Baseline to time of event (up to approximately 8 years)||2020||||
680604|NCT01566721|Primary|Percentage of Participants Who Received Concomitant Non-Cancer Therapy|Concomitant non-cancer treatment included any pharmacologic interventions administered during the study other than chemotherapy, radiotherapy, or hormone therapy. The percentage of participants who received any concomitant non-cancer therapies was reported.|From Baseline to data cutoff of 10 March 2015 (up to approximately 3 years)|Safety Population||percentage of participants|||Number
680605|NCT01566721|Primary|Percentage of Participants Who Received Concomitant Cancer Therapy|Concomitant cancer treatment included chemotherapy, radiotherapy, and hormone therapy administered during the study. The percentage of participants who received any of these concomitant therapies was reported.|From Baseline to data cutoff of 10 March 2015 (up to approximately 3 years)|Safety Population||percentage of participants|||Number
680606|NCT01566721|Primary|Percentage of Participants by Total Number of Herceptin Cycles Received|Participants were planned to receive a total of 18 cycles of SC Herceptin. The percentage of participants was reported by the total number of cycles actually received. Because the data are presented non-cumulatively, this table reflects participant distribution by the highest number of cycles received.|From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)|Safety Population. The endpoint also included an analysis of a subgroup of participants from Cohort B who received doses of self-administered SC Herceptin via SID.||percentage of participants|||Number
680607|NCT01566721|Primary|Number of Herceptin Cycles Received|Participants were planned to receive a total of 18 cycles of SC Herceptin. The median number of cycles actually received was reported.|From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)|Safety Population. The endpoint also included an analysis of a subgroup of participants from Cohort B who received doses of self-administered SC Herceptin via SID.||cycles||Full Range|Median
680608|NCT01566721|Primary|Percentage of Participants With Treatment Interruption Due to an AE|Participants were planned to receive a total of 18 cycles of SC Herceptin. An AE was defined as any untoward medical occurrence in a participant administered SC Herceptin. Examples included unfavorable/unintended signs and symptoms, new or exacerbated disease, recurrence of intermittent condition, deterioration in laboratory value or other clinical test, or adverse procedure-related events. The percentage of participants with SC Herceptin treatment interrupted to assess or treat AEs was reported.|From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)|Safety Population||percentage of participants|||Number
680609|NCT01566721|Primary|Percentage of Participants With a Grade 3 or Higher AE During the Treatment Period|Participants were planned to receive a total of 18 cycles of SC Herceptin. An AE was defined as any untoward medical occurrence in a participant administered SC Herceptin. Examples included unfavorable/unintended signs and symptoms, new or exacerbated disease, recurrence of intermittent condition, deterioration in laboratory value or other clinical test, or adverse procedure-related events. AEs were graded according to National Cancer Institute Common Terminology Criteria Version 4.0. Grade 3 AEs were those considered severe or medically significant but not immediately life-threatening. Grade 4 AEs were those considered life-threatening and/or for which urgent intervention was indicated. Grade 5 AEs were those resulting in death. The percentage of participants with a Grade 3 or higher (i.e., Grade 3 to 5) AE during the treatment period was reported.|From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)|Safety Population||percentage of participants||95% Confidence Interval|Number
680610|NCT01566721|Primary|Percentage of Participants With At Least 1 Adverse Event (AE) During the Treatment Period|Participants were planned to receive a total of 18 cycles of SC Herceptin. An AE was defined as any untoward medical occurrence in a participant administered SC Herceptin. Examples included unfavorable/unintended signs and symptoms, new or exacerbated disease, recurrence of intermittent condition, deterioration in laboratory value or other clinical test, or adverse procedure-related events. The percentage of participants with at least 1 AE during the treatment period (regardless of severity or seriousness) was reported.|From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)|Safety Population: All enrolled participants who received at least one dose of study medication according to assigned treatment.||percentage of participants|||Number
680611|NCT01566630|Secondary|Mean Number of Days Before Delivery||From randomization until delivery (maximum of 3 weeks)|No formal analysis was performed as the study was terminated after three patients were enrolled and dosed|||||
680612|NCT01566630|Primary|Pharmacokinetics of RLX030: Mean Residence Time (MRT)|Blood concentrations of RLX-030 was assayed to determine this PK parameter.|Baseline, 2, 6, 24,48,72, 76, 80 and 90 hours after initiation of infusion during part 1|No formal analysis was performed as the study was terminated after three patients were enrolled and dosed|||||
680614|NCT01566630|Primary|Pharmacokinetics of RLX030: Blood Concentration at 24 Hour (C 0-24h) After Administration- Part 1|Blood concentrations of RLX-030 was assayed to determine this PK parameter.|Baseline, 2, 6, 24,48,72, 76, 80 and 90 hours after initiation of infusion during part 1|No formal analysis was performed as the study was terminated after three patients were enrolled and dosed|||||
680615|NCT01566630|Primary|Pharmacokinetics of RLX030: Area Under the Blood Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast)-Part 1|Blood concentrations of RLX-030 was assayed to determine this PK parameter.|Baseline, 2, 6, 24,48,72, 76, 80 and 90 hours after initiation of infusion during part 1|No formal analysis was performed as the study was terminated after three patients were enrolled and dosed|||||
680616|NCT01566630|Primary|Pharmacokinetics of RLX030: Area Under the Blood Concentration-time Curve From Time Zero to Infinity (AUCinf)-Part 1|Blood concentrations of RLX-030 was assayed to determine this PK parameter.|Baseline, 2, 6, 24,48,72, 76, 80 and 90 hours after initiation of infusion during part 1|No formal analysis was performed as the study was terminated after three patients were enrolled and dosed|||||
680617|NCT01566630|Primary|Number of Patients With Abnormalities in Fetal Cardiotocography and Biophysical Profile||Randomization to delivery (maximum of 3 weeks)|No formal analysis was performed as the study was terminated after three patients were enrolled and dosed|||||
680618|NCT01566630|Primary|Number of Patients With Abnormalities in Birth Weight, Gestational Age, Appearance, Pulse, Grimace, Activity, Respiration (APGAR) Score, Umbilical Cord Gases, and Days in Neonatal Intensive Care Unit (NICU)||up to 4 - 6 weeks post partum (maximum of 8 weeks )|No formal analysis was performed as the study was terminated after three patients were enrolled and dosed|||||
680619|NCT01566630|Primary|Number of Patients With Absence of Anti-serelaxin Antibodies||From Randomization until 4-6 weeks post partum (maximum of 8 weeks)|No formal analysis was performed as the study was terminated after three patients were enrolled and dosed|||||
680620|NCT01566630|Primary|Rate of Spontaneous Delivery and/or Mode of Delivery||From randomization to delivery (maximum of 3 weeks)|No formal analysis was performed as the study was terminated after three patients were enrolled and dosed|||||
680621|NCT01566630|Primary|Improvement in Renal Function Assessed by Increase in Creatinine Clearance||From randomization until 4-6 weeks post partum (maximum 8 weeks)|No formal analysis was performed as the study was terminated after three patients were enrolled and dosed|||||
680622|NCT01566630|Primary|Change in Fetal Heart Rate (Part 1)|Heart rate of fetus was monitored continuously throughout 72 hour treatment period using a cardiotocograph.|During treatment period of a maximum 72 hours infusion prior to delivery and up to delivery in part 1 (maximum of 3 weeks)|No formal analysis was performed as the study was terminated after three patients were enrolled and dosed|||||
680623|NCT01566630|Primary|Decrease in Utero-placental Blood Flow (Part 1)|Blood flow to the fetus was monitored using via a Doppler.|During treatment period of a maximum 72 hours infusion prior to delivery and up to delivery in part 1 (maximum of 3 weeks)|No formal analysis was performed as the study was terminated after three patients were enrolled and dosed|||||
680624|NCT01566630|Primary|Change From Baseline on Maternal Proteinuria (Part 1)|Pre-eclampsia was monitored by checking levels of protein in urine and by urinary protein/creatinine ratio (UPCR)|From baseline to during treatment period of a maximum 72 hours infusion prior to delivery until 4-6 weeks post partum in part 1 (maximum of 8 weeks)|No formal analysis was performed as the study was terminated after three patients were enrolled and dosed|||||
680625|NCT01566630|Primary|Change From Baseline in Mean Maternal Arterial Pressure (Part 1)|Maternal safety assessment to monitor pre-eclampsia by checking mean arterial pressure during 72 hour treatment period as well as post-dose.|From baseline to during treatment period of a maximum 72 hours infusion prior to delivery until 4-6 weeks post partum in part 1 (maximum of 8 weeks)|No formal analysis was performed as the study was terminated after three patients were enrolled and dosed|||||
680626|NCT01566630|Primary|Change From Baseline in Maternal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Part 1of the Study (Part 1)|Maternal safety assessment to monitor pre-eclampsia by checking blood pressure during 72 hour treatment period as well as post-dose.|From baseline to during treatment period of a maximum 72 hours infusion prior to delivery until 4-6 weeks post partum in part 1 (maximum of 8 weeks)|No formal analysis was performed as the study was terminated after three patients were enrolled and dosed|||||
680627|NCT01566630|Primary|Number of Patients With Adverse Events, Serious Adverse and Death During Part 1 of the Study|Safety and tolerability was assessed by adverse events/serious adverse event and death monitoring.|Prior to delivery until 4-6 weeks post partum (maximum of 8 weeks)|No formal analysis was performed as the study was terminated after three patients were enrolled and dosed.||Participants|||Number
680628|NCT01566604|Secondary|The Total Score of the St George's Respiratory Questionnaire (SGRQ)|SGRQ is a health related quality of life questionnaire consisting of 51 items in three components: symptoms, activity and impacts. The lowest possible score is zero and the highest possible score is 100. Higher scores correspond to greater impairment in quality of life. The health-related quality of life was measured using SGRQ. It was completed by the participant at the investigators site.|Week 12, week 26|The number of participants considered for the analysis was from the full analysis set (randomized participants who received at least one dose of study medication). However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. week 12 or week 26.||Score||Standard Error|Least Squares Mean
680629|NCT01566604|Secondary|Number of Moderate and Severe COPD Exacerbations|COPD exacerbations were recorded in the patient diary and other source documents. The rate of COPD exacerbations during the 26 week treatment period was analyzed using a generalized linear model assuming a negative binomial distribution.|26 weeks|Full Analysis Set: The full analysis set included all randomized patients who received at least one dose of study medication.||Number of exacerbations||Standard Deviation|Mean
680630|NCT01566604|Secondary|Time to First Moderate or Severe COPD Exacerbation|A COPD exacerbation was defined as a worsening of the following two or more major symptoms for at least 2 consecutive days:1) dyspnea; 2) sputum volume; 3) sputum purulence; or defined as a worsening of any 1 major symptom together with an increase in any 1 of the following minor symptoms for at least 2 consecutive days: 1) sore throat; 2) colds (nasal discharge and/or nasal congestion); 3) fever without other cause; 4) cough; 5) wheeze. COPD exacerbations were recorded in the patient diary and other source documents.|26 weeks|Full Analysis Set: The full analysis set included all randomized patients who received at least one dose of study medication.||Days||Full Range|Median
680631|NCT01566604|Secondary|Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptoms (Cough, Wheezing, Shortness of Breath, Sputum Volume, Sputum Color and Night Time Awakenings)|In an electronic diary, the participant responded to 6 questions twice daily to report on the degree of symptoms over the past 12 hours of the morning and evening. The questions covered the participant’s degree of overall symptoms, and degrees of individual symptoms of coughing, wheezing, amount of sputum, color of sputum and breathlessness. Each question scored from 0 to 3 where 0 represented no symptom present and 3 represented the worst degree of that symptom. A negative change in symptom score indicates improvement.|Baseline, 26 weeks|The number of participants considered for the analysis was from the full analysis set (randomized participants who received at least one dose of study medication). However, for a given symptom category, analyzed participants had both baseline and week 26 values.||score||Standard Error|Least Squares Mean
680632|NCT01566604|Secondary|Standardized FEV1 Area Under the Curve (AUC(5 Min-4 h)) Post-dose|The standardized (with respect to time) AUC for FEV1 was calculated between 5 min and 4h post morning dose at day 1, week 12 and week 26. The AUC (5 min-4 h) for FEV1 at each visit was analyzed using the same MIXED model as specified for the primary analysis.|Day 1, week 12, week 26|The number of participants considered for the analysis was from a Serial Spirometry subgroup of the full analysis set where N = 134 and 58, respectively. However, analyzed participants had values at both baseline and the corresponding time frame, i.e. day 1, week 12 or week 26.||Liters||Standard Error|Least Squares Mean
680633|NCT01566604|Secondary|Peak FEV1|Peak FEV1 was defined as the maximum FEV1 0-4 h post-dose. Peak Fev1 was measured at 45min and 15min pre-dose and up to 4h post dose at day 1, week 12 and week 26, using central spirometry according to ATS/ERS standardization. It was analyzed using the same MIXED model as specified for the primary analysis.|Day 1, week 12, week 26|The number of participants considered for the analysis was from a Serial Spirometry subgroup of the full analysis set where N = 134 and 58, respectively. However, analyzed participants had values at both baseline and the corresponding time frame, i.e. day 1, week 12 or week 26.||Liters||Standard Error|Least Squares Mean
680634|NCT01566604|Secondary|FEV1 and Forced Vital Capacity (FVC)|FEV1 and FVC were measured using central spirometry according to ATS/ERS standardization. Both were analyzed using the same MIXED model as specified for the primary analysis.|Day 1 at 5, 15, 30 minutes (min) and 1 hour (h) post dose; days 2, 86, 184 at 23 (h) 15 min and 23 h 45 min post dose; days 29, 85, 183 at -45 and -15 min pre-dose and 5, 15, and 30 min post dose|The number of participants considered for the analysis was from the full analysis set (randomized participants who received at least one dose of study medication). However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, e.g. day 1, 5 min; day 1, 15 min, etc..||Liters||Standard Error|Least Squares Mean
680635|NCT01566604|Secondary|24h Trough FEV1|Trough FEV1 was defined as the mean of the post-dose 23 h 15 min and the 23 h 45 min FEV1 values. This was measured using central spirometry according to ATS/ERS standardization. This was analyzed using the same MIXED model as specified for the primary analysis.|Day 1, Week 26|The number of participants considered for the analysis was from the full analysis set (randomized participants who received at least one dose of study medication). However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. day 1 or week 26.||Liters||Standard Error|Least Squares Mean
680636|NCT01566604|Secondary|Change From Baseline in Daily Rescue Medication Use (Number of Puffs)|The participant recorded the rescue medication taken in an electronic diary between visits and in the spirometry device during study visits. Daytime and nighttime rescue medication use (number of puffs) over 26 weeks was analyzed.|Baseline, 26 weeks|Full Analysis Set: The full analysis set included all randomized participants who received at least one dose of study medication.||Number of puffs||Standard Error|Least Squares Mean
680637|NCT01566604|Secondary|Transition Dyspnea Index (TDI) Score|Dyspnea was measured at baseline using the Baseline Dyspnea Index (BDI) and during the treatment period using the TDI, which captures changes from baseline. The BDI and TDI each have three domains: functional impairment, magnitude of task and magnitude of effort, and each domain scored from -3 (major deterioration) to +3 (major improvement), giving an overall score of -9 to +9. A negative score indicates deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement from baseline.|Baseline, week 12, week 26|The number of participants considered for the analysis was from the full analysis set (randomized participants who received at least one dose of study medication). However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. week 12 or week 26.||score||Standard Error|Least Squares Mean
680638|NCT01566604|Primary|Trough Forced Expiratory Volume in One Second (FEV1)|Baseline FEV1 was defined as the average of the -45 min and -15 min FEV1 values taken on day 1 prior to the first dose of study medication. Trough FEV1 was defined as the mean of the post-dose 23 h 15 min and the 23 h 45 min FEV1 values. FEV1 was measured using central spirometry according to ATS/ERS standardization. Trough FEV1 was analyzed using a MIXED model for the full analysis set population. The model contained treatment as a fixed effect with the baseline FEV1 measurement, FEV1 prior to inhalation of short acting bronchodilator, FEV1 45 min post inhalation of short acting bronchodilator and baseline inhaled corticosteroids (ICS) use as covariates.|12 weeks|The number of participants considered for the analysis was from the full analysis set (randomized participants who received at least one dose of study medication). However, participants analyzed had both baseline and week 12 values.||Liters||Standard Error|Least Squares Mean
680639|NCT01566539|Other Pre-specified|Healthy Volunteers Groups: Mean Testosterone Plasma Level|Peripherals levels of testosterone will be assessed via assay of plasma collected.|Visit 1 (Up to 3 Hours)|Analysis was completed in the first batch of data collection from Healthy Volunteers - Intranasal Vasopressin (AVP), Healthy Volunteers - Intranasal Oxytocin (OT), and Healthy Volunteers - Intranasal Placebo groups per protocol. Due to the lack of funds, no subsequent analysis has been done on the samples collected.||ng/dl||Standard Deviation|Mean
680640|NCT01566539|Other Pre-specified|Healthy Volunteers Groups: Mean Oxytocin (OT) Plasma Level|Peripheral levels of OT will be assessed via assay of plasma collected.|Visit 1 (Up to 3 Hours)|Analysis was completed in the Healthy Volunteers - Intranasal Vasopressin (AVP), Healthy Volunteers - Intranasal Oxytocin (OT), and Healthy Volunteers - Intranasal Placebo groups per protocol. Subjects with unreliable or missing data were excluded from the analysis.||pg/ml||Standard Error|Mean
680641|NCT01566539|Other Pre-specified|Healthy Volunteers Groups: Mean Vasopressin (AVP) Plasma Level|Peripheral levels of AVP will be assessed via assay of plasma collected.|Visit 1 (Up to 3 Hours)|Analysis was completed in the Healthy Volunteers - Intranasal Vasopressin (AVP), Healthy Volunteers - Intranasal Oxytocin (OT), and Healthy Volunteers - Intranasal Placebo groups per protocol. Subjects with unreliable or missing data were excluded from the analysis.||pg/ml||Standard Error|Mean
680642|NCT01566539|Secondary|Empathy Task Groups: Mean Percent Signal Change in Early Visual Cortex in Response to Animation in Men|The effect of the drug treatment will be assessed by determining differences in brain activation between OT and PL group when participants are viewing animations.|Visit 1 (40-75 Minutes Post-Intervention), Visit 2 (Up to 1 Month)|Data was collected per protocol in the OT and placebo empathy task groups.||percent signal change||Standard Deviation|Mean
680643|NCT01566539|Secondary|Empathy Task Groups: Mean Percent Signal Change in Early Visual Cortex in Response to Animation in Women|The effect of the drug treatment will be assessed by determining differences in brain activation between OT and PL group when participants are viewing animations.|Visit 1 (40-75 Minutes Post-Intervention), Visit 2 (Up to 1 Month)|Data was collected per protocol in the OT and placebo empathy task groups.||percent signal change||Standard Deviation|Mean
680644|NCT01566539|Secondary|Faces Task Groups: Mean Attractiveness Rating of Faces in Women|Attractiveness is rated by a study specific seven point scale where -3 indicates least attractive and +3 indicates most attractive. Participants will rate same-sex and other-sex faces. The effect of the drug treatment will be assessed by determining differences in attractiveness ratings between AVP and PL group when participants are viewing same-sex faces, and when participants are viewing other-sex faces.|Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 7 Days)|Data was collected per protocol in the AVP and placebo faces groups.||units on a scale||Standard Deviation|Mean
680645|NCT01566539|Secondary|Faces Task Groups: Mean Attractiveness Rating of Faces in Men|Attractiveness is rated by a study specific seven point scale where -3 indicates least attractive and +3 indicates most attractive. Participants will rate same-sex and other-sex faces. The effect of the drug treatment will be assessed by determining differences in attractiveness ratings between AVP and PL group when participants are viewing same-sex faces, and when participants are viewing other-sex faces.|Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 7 Days)|Data was collected per protocol in the AVP and placebo faces groups.||units on a scale||Standard Deviation|Mean
680646|NCT01566539|Secondary|Faces Task Group: Mean Approachability Rating of Faces in Women|Approachability is rated by a study specific seven point scale where -3 indicates threatening and unapproachable and +3 indicates friendly and approachable. Participants will rate same-sex and other-sex faces. The effect of the drug treatment will be assessed by determining differences in approachability ratings between AVP and PL group when participants are viewing same-sex faces, and when participants are viewing other-sex faces.|Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 7 Days)|Data was collected per protocol in the AVP and placebo faces groups.||units on a scale||Standard Deviation|Mean
680647|NCT01566539|Secondary|Faces Task Groups: Mean Approachability Rating of Faces in Men|Approachability is rated by a study specific seven point scale where -3 indicates threatening and unapproachable and +3 indicates friendly and approachable. Participants will rate same-sex and other-sex faces. The effect of the drug treatment will be assessed by determining differences in approachability ratings between AVP and PL group when participants are viewing same-sex faces, and when participants are viewing other-sex faces.|Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 7 Days)|Data was collected per protocol in the AVP and placebo faces groups.||units on a scale||Standard Deviation|Mean
680648|NCT01566539|Secondary|Faces Task Groups: Mean Percent Signal Change in Nucleus Accumbens to Faces in Women|The effect of the drug treatment will be assessed by determining differences in brain activation between AVP and PL group when participants are viewing same-sex faces, and when participants are viewing other-sex faces.|Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 7 Days)|Analysis was completed for the Faces Task - Vasopressin (AVP) and Faces Task - Placebo groups per protocol. Subjects with missing data were excluded from the analysis.||percent signal change||Standard Deviation|Mean
680649|NCT01566539|Secondary|Faces Task Groups: Mean Percent Signal Change in Nucleus Accumbens to Faces in Men|The effect of the drug treatment will be assessed by determining differences in brain activation between AVP and PL group when participants are viewing same-sex faces, and when participants are viewing other-sex faces.|Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 7 Days)|Analysis was completed for the Faces Task - Vasopressin (AVP) and Faces Task - Placebo groups per protocol. Subjects with missing data were excluded from the analysis.||percent signal change||Standard Deviation|Mean
680650|NCT01566539|Secondary|Within Subject Group: Mean Difference in Number of Cooperate Choices Made by Female During the Prisoners Dilemma Game|"The effect of the drug treatments will be assessed by determining the number of cooperative choices made during the prisoner's dilemma game. Participants may make two choices that are considered cooperative. The higher the total number, the more cooperative choices made."|Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 2 Weeks)|Analysis was completed for the Within Subject Group per protocol. Subjects with missing data were excluded from the analysis.||number of choices||Standard Deviation|Mean
680651|NCT01566539|Secondary|Within Subject Group: Mean Difference in Number of Cooperate Choices Made by Male During the Prisoners Dilemma Game|"The effect of the drug treatments will be assessed by determining the number of cooperative choices made during the prisoner's dilemma game. Participants may make two choices that are considered cooperative. The higher the total number, the more cooperative choices made."|Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 2 Weeks)|Analysis was completed for the Within Subject Group per protocol. Subjects with missing data were excluded from the analysis. The difference between OT and PL visits is reported here (OT-PL).||number of choices||Standard Deviation|Mean
680652|NCT01566539|Secondary|Healthy Volunteer Groups: Total Number of Cooperate Choices Made by Women During the Prisoners Dilemma Game|"The effect of the drug treatments will be assessed by determining the number of cooperative choices made during the prisoner's dilemma game. Participants may make two choices that are considered cooperative. The higher the total number, the more cooperative choices made."|Visit 1 (40-100 Minutes Post-Intervention)|Analysis was completed for the Healthy Volunteers - Intranasal Vasopressin (AVP), Healthy Volunteers - Intranasal Oxytocin (OT), and Healthy Volunteers - Intranasal Placebo groups per protocol. Subjects with missing data were excluded from the analysis.||number of choices||Standard Error|Mean
680653|NCT01566539|Secondary|Healthy Volunteer Groups: Total Number of Cooperate Choices Made by Men During the Prisoners Dilemma Game|"The effect of the drug treatments will be assessed by determining the number of cooperative choices made during the prisoner's dilemma game. Participants may make two choices that are considered cooperative. The higher the total number, the more cooperative choices made."|Visit 1 (40-100 Minutes Post-Intervention)|Analysis was completed for the Healthy Volunteers - Intranasal Vasopressin (AVP), Healthy Volunteers - Intranasal Oxytocin (OT), and Healthy Volunteers - Intranasal Placebo groups per protocol. Subjects with missing data were excluded from the analysis.||number of choices||Standard Error|Mean
680654|NCT01566539|Primary|Within Subject Group: Mean Percent Signal Change in Left Caudate Nucleus in Men and Women|The effect of the drug will be assessed by determining changes in brain activation between the visit where the participant received drug and the visit where the participant received PL in the right caudate during reciprocated cooperation in Prisoner Dilemma game while undergoing an fMRI scan.|Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 2 Weeks)|Analysis was completed for the within subject group per protocol. Subjects with excessive motion during scanning were excluded from the analysis.||percent signal change||Standard Deviation|Mean
680655|NCT01566539|Primary|Healthy Volunteers-AVP, Placebo: Mean Percent Signal Change in Left Insula in Women|The effect of the drug treatment will be assessed by determining differences in brain activation between AVP and placebo groups in the left insula during reciprocated cooperation in Prisoner Dilemma game while undergoing an fMRI scan.|Visit 1 (40-100 Minutes Post-Intervention)|Analysis was completed in the Healthy Volunteers - Intranasal Vasopressin (AVP) and Healthy Volunteers - Intranasal Placebo groups per protocol. Subjects with excessive motion, missing data, abnormal brain anatomy or partial data collection were excluded from the analysis.||percent signal change||Standard Error|Mean
680656|NCT01566539|Primary|Healthy Volunteers-AVP, Placebo: Mean Percent Signal Change in Left Insula in Men|The effect of the drug treatment will be assessed by determining differences in brain activation between AVP and placebo groups in the left insula region during reciprocated cooperation in Prisoner Dilemma game while undergoing an fMRI scan.|Visit 1 (40-100 Minutes Post-Intervention)|Analysis was completed in the Healthy Volunteers - Intranasal Vasopressin (AVP) and Healthy Volunteers - Intranasal Placebo groups per protocol. Subjects with excessive motion, missing data, abnormal brain anatomy or partial data collection were excluded from the analysis.||percent signal change||Standard Error|Mean
680657|NCT01566539|Primary|Healthy Volunteers-OT, Placebo: Mean Percent Signal Change in Right Caudate Nucleus in Women|The effect of the drug treatment will be assessed by determining differences in brain activation between OT and placebo groups in the right caudate nucleus region during reciprocated cooperation in Prisoner Dilemma game while undergoing an fMRI scan.|Visit 1 (40-100 Minutes Post-Intervention)|Analysis was completed in the Healthy Volunteers - Intranasal Oxytocin (OT) and Healthy Volunteers - Intranasal Placebo groups per protocol. Subjects with excessive motion, missing data, abnormal brain anatomy or partial data collection were excluded from the analysis.||percent signal change||Standard Error|Mean
680658|NCT01566539|Primary|Healthy Volunteers-OT, Placebo: Mean Percent Signal Change in Right Caudate Nucleus in Men|The effect of the drug treatment will be assessed by determining differences in brain activation between OT and placebo groups in the right caudate nucleus region during reciprocated cooperation in Prisoner Dilemma game while undergoing an fMRI scan.|Visit 1 (40-100 Minutes Post-Intervention)|Analysis was completed in the Healthy Volunteers - Intranasal Oxytocin (OT) and Healthy Volunteers - Intranasal Placebo groups per protocol. Subjects with excessive motion, missing data, abnormal brain anatomy or partial data collection were excluded from the analysis.||percent signal change||Standard Error|Mean
680659|NCT01566526|Secondary|Time to Improvement of 3 Lines or More in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA following the first injection of OZURDEX® is measured in the study eye using a special eye chart and is reported as the number of lines (5 letters per line) read correctly. An increase of 3 lines or more indicates an improvement.|Baseline, Up to 12 Months|All enrolled patients with data for this data point who had an improvement of ≥ 3 lines in BCVA.||Days||Full Range|Median
680660|NCT01566526|Secondary|Time to Improvement of 2 Lines or More in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA following the first injection of OZURDEX® is measured in the study eye using a special eye chart and is reported as the number of lines (5 letters per line) read correctly. An increase of 2 lines or more indicates an improvement.|Baseline, Up to 12 Months|All enrolled patients with data for this data point who had an improvement of ≥ 2 lines in BCVA.||Days||Full Range|Median
680661|NCT01566526|Secondary|Change From Baseline in Central Retinal Thickness in the Study Eye by Optical Coherence Tomography (OCT) 7 to 12 Weeks Following Last Injection|OCT is measured in the study eye following each injection of OZURDEX®. OCT is a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina to assess retinal thickness. A negative change indicates an improvement. Data are reported for the 7-12 week period following the last injection.|Baseline, 7 to 12 weeks following the last injection|All enrolled patients with data for this data point.||Micrometers (µm)||Standard Deviation|Mean
680662|NCT01566526|Secondary|Percentage of Patients With an Increase of 3 Lines or More in BCVA From Baseline in the Study Eye|BCVA following the first injection of OZURDEX® is measured in the study eye using a special eye chart and is reported as the number of lines (5 letters per line) read correctly. An increase of 3 lines or more indicates an improvement.|Baseline, Up to 12 Months|All enrolled patients with data for this data point.||Percent of Participants|||Number
680663|NCT01566526|Secondary|Percentage of Patients With an Increase of 2 Lines or More in BCVA From Baseline in the Study Eye|BCVA following the first injection of OZURDEX® is measured in the study eye using a special eye chart and is reported as the number of lines (5 letters per line) read correctly. An increase of 2 lines or more indicates an improvement.|Baseline, Up to 12 Months|All enrolled patients with data for this data point.||Percent of Participants|||Number
680682|NCT01566461|Secondary|Time to First Clinically Driven Target Lesion Revascularization (CD-TLR)|Clinically-driven target lesion revascularization (CD-TLR) is defined as any re-intervention within the target lesion due to symptoms or drop of ankle brachial index (ABI) of ≥20% or >0.15 when compared to post procedure baseline.|12 month|Includes all subjects who experienced a CD-TLR.||Days||Standard Deviation|Mean
680683|NCT01566461|Secondary|Target Lesion Revascularization (TLR)||12 month|Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.||Percentage of participants|||Number
680664|NCT01566526|Secondary|Change From Baseline in Best Corrected Visual Acuity (BCVA) 7 to 12 Weeks Following Last Injection in the Study Eye|BCVA is measured in the study eye following each injection of OZURDEX® using a special eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number improvement in the number of letters read means that the vision has improved. Data are reported for the 7-12 week period following the last injection.|Baseline, 7 to 12 weeks following the last injection|All enrolled patients with data for this data point.||Letters||Standard Deviation|Mean
680665|NCT01566526|Primary|Time to OZURDEX® Re-Injection in the Study Eye|The time interval is measured from the first OZURDEX® injection to the second OZURDEX® injection in the study eye.|Up to 12 Months|All enrolled patients.||Days||Standard Deviation|Mean
680666|NCT01566500|Secondary|Score of Psychosocial Predictors of Adherence|The Fisher IMB (Information-Seeking, Motivation and Behavior) adherence questionnaire will measure what psychosocial factors that act as predictive of medication adherence. The items pertaining to barriers to medication adherence were assessed the same day as enrollment and have a twelve month recall period.|Enrollment||||||
680667|NCT01566500|Secondary|Score on Barriers to Medication Adherence|The Chesney Adherence Questionnaire will be used to measure side effects, drug use and other barriers to medication adherence. The items pertaining to barriers to medication adherence were assessed the same day as enrollment and have a four-week recall period.|Enrollment||||||
680668|NCT01566500|Primary|Raw Count of Number of Days of Medication Nonadherence|"The primary outcome of this study is medication adherence as measured by self report with a 4 day recall adherence questionnaire (Chesney, Ickovics, Chambers, et al., 2000).
The total number of Nonadherence days were counted, then divided by the total number of days for all participants."|Enrollment|Adults with self-reported epilepsy.||% of nonadherence days|||Number
680669|NCT01566461|Secondary|Days of Hospitalization Due to the Index Lesion|Days of hospitalization from procedure through 12 month.|12 month|Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.||Days||Standard Deviation|Mean
680670|NCT01566461|Secondary|Clinical Success|Clinical success is defined as procedural success without procedural complications (death, major target limb amputation, thrombosis of the target lesion, or Target vessel revascularization (TVR)) prior to discharge.|Day 1|Intention-to-Treat (n=331)||Percentage of participants|||Number
680671|NCT01566461|Secondary|Procedural Success|Procedural success is defined as residual stenosis of ≤50% (non-stented subjects) or ≤30% (stented subjects) by core lab assessment.|Day 1|Intention-to-Treat (n=331)||Percentage of participants|||Number
680672|NCT01566461|Secondary|Device Success|Device success is defined as successful delivery, balloon inflation and deflation and retrieval of the intact study device without burst below rated burst pressure (RBP).|Day 1|Total number of devices used in the ITT population (n=331).||Percentage of devices|Devices||Number
680673|NCT01566461|Secondary|Walking Capacity Assessment by Walking Impairment Questionnaire (WIQ)|"Walking capacity assessment by WIQ at 1 year compared to baseline. WIQ is a quality of life questionnaire that was specifically designed to assess the degree of impairment experienced by patients with claudication.
Clinical outcomes were assessed by patients responses to question 1A. Question 1A is specific for calf or buttocks claudication and is used to create a summary score for analysis. Question 1A is expressed on a scale of 0% (unable to perform because of severe claudication) to 100% (no impairment)."|12 month|Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.||Units on a scale||Standard Deviation|Mean
680674|NCT01566461|Secondary|Change in Walking Distance as Assessed by Six Minute Walk Test (6MWT)|Change from baseline in walking distance by Six Minute Walk Test (6MWT) at 12 month.|From baseline to 12 month|Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe. Data not collected in IN.PACT SFA I phase.||Meters||Standard Deviation|Mean
680675|NCT01566461|Secondary|Quality of Life Assessment by EuroQol Group 5-Dimension Self-Report Questionnaire (EQ5D)|"Quality of life assessment by EQ5D at 1 year compared to baseline. EQ5D is a standardised measure of health status and economic appraisal. The EQ5D consists of the EQ5D descriptive system which comprises the following variables for the 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: (1) no problems, (2) some problems, (3) extreme problems. A complex algorithm that took individual dimensions and generated an overall score was used.
EQ5D health state is used in the algorithm to calculate an overall score where - 0.109 = 'worst possible outcome' and 1.000 = 'best possible outcome'."|12 month|Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.||Units on a scale||Standard Deviation|Mean
680676|NCT01566461|Secondary|Duplex-defined Binary Restenosis (Peak Systolic Velocity Ratio (PSVR) >3.4)||12 month|Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.||Percentage of participants|||Number
680677|NCT01566461|Secondary|Duplex-defined Binary Restenosis (Peak Systolic Velocity Ratio (PSVR) >2.4)||12 month|Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.||Percentage of participants|||Number
680678|NCT01566461|Secondary|Secondary Sustained Clinical Improvement|Freedom from target amputation and increase in Rutherford class.|12 month|Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.||Percentage of particpants|||Number
680679|NCT01566461|Secondary|Primary Sustained Clinical Improvement|Freedom from target limb amputation, target vessel revascularization (TVR), and increase in Rutherford class.|12 month|Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.||Percentage of participants|||Number
680680|NCT01566461|Secondary|Thrombosis at the Target Lesion||12 month|Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.||Percentage of participants|||Number
680681|NCT01566461|Secondary|Major Target Limb Amputation||12 month|Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.||Percentage of participants|||Number
680684|NCT01566461|Secondary|Target Vessel Revascularization (TVR)||12 month|Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.||Percentage of participants|||Number
680686|NCT01566461|Secondary|Major Adverse Event (MAE) Composite|Major Adverse Event (MAE) composite is defined as all cause death, clinically-driven target vessel revascularization, major target limb amputation, thrombosis at the target lesion site.|12 month|Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.||Percentage of participants|||Number
680687|NCT01566461|Primary|Primary Safety Composite|Primary safety composite is defined as freedom from death through 30 days or target limb major amputation or clinically-driven target vessel revascularization (CD-TVR) within 12 months post index procedure.|12 month|Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.||Percentage of particpants|||Number
680688|NCT01566461|Primary|Primary Patency|Primary patency is defined as freedom from clinically-driven target lesion revascularisation (CD-TLR) or restenosis as determined by duplex ultrasound (DUS) Peak Systolic Velocity Ratio (PSVR) ≤2.4.|12 month|Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.||Percentage of participants|||Number
680689|NCT01566435|Secondary|Progression-free Survival (PFS)|-Progression: at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|2 years|||percentage of participants|||Number
680690|NCT01566435|Secondary|Disease-free Survival (DFS) Rate||2 years|||percentage of participants|||Number
680691|NCT01566435|Secondary|Changes in Ki-67 Expression by Immunohistochemistry (IHC) in Primary Tumor Tissue|Ki-67 expression will be assessed at this institution by IHC stains performed on clinically available tumor specimens (paraffin blocks). The specimens will be collected retrospectively from prior biopsies (pre treatment and following 2 cycles of ACF) that will have consisted of a minimum of two needle cores (16-18 gauge) or two small incisional/excisional pieces of tumor. These will have been placed in 2% buffered formalin and transported to the surgical pathology processing lab.|6 weeks (2 cycles of therapy)||10/2023||||
680692|NCT01566435|Secondary|Complete Response (CR) or Partial Response (PR) at Regional (Neck) Nodes as Measured by Clinical Exam||6 weeks (2 cycles of therapy)|2 participants were not evaluable for this outcome measure.||participants|||Number
680693|NCT01566435|Secondary|Quality of Life (QOL)|"Assessed using questionnaires administered at 6 time points starting at baseline.
4 page questionnaire will assess physical, social, emotional, and functional well-being through questions designed specifically for patients with head and neck cancer.
An additional 4 question QOL survey will assess symptoms of peripheral neuropathy."|Through one year after completion of treatment||10/2023||||
680694|NCT01566435|Secondary|Changes in Secreted Protein Acidic and Rich in Cysteine (SPARC) Expression by Immunohistochemistry (IHC) in Primary Tumor Tissue|SPARC and Ki-67 expression will be assessed at this institution by IHC stains performed on clinically available tumor specimens (paraffin blocks). The specimens will be collected retrospectively from prior biopsies (pre treatment and following 2 cycles of ACF) that will have consisted of a minimum of two needle cores (16-18 gauge) or two small incisional/excisional pieces of tumor. These will have been placed in 2% buffered formalin and transported to the surgical pathology processing lab.|6 weeks (2 cycles of therapy)||10/2023||||
680695|NCT01566435|Secondary|Adverse Events as Measured by Number of Participants That Experienced Each Common Adverse Event During ACF Induction Therapy|Assessed by NCI-CTCAE version 3|From start of treatment through 30 days after end of treatment|||participants|||Number
680696|NCT01566435|Secondary|Overall Survival Rate|-Overall survival rate is the percentage of participants who are alive at 2 years.|2 years|||percentage of participants|||Number
680697|NCT01566435|Secondary|Metabolic Tumor Responses as Measured by FDG-PET/CT|"Complete metabolic response (CMR): Complete resolution of all metabolically active target and non-target lesions, and no interval development of new lesions
Partial metabolic response (PMR): 20% or greater decrease in max SUV from baseline, no metabolic progression of non-target lesions and no new lesions and/or decrease in total number of non-target lesions, no new lesions
Stable metabolic disease (SMD) - does not qualify for CMR, PMR, or PMD
Progressive metabolic disease (PMD): development of one or more metabolically active lesions or 20% or greater increased in max SUV from baseline, new metabolically active lesions"|6 weeks (2 cycles of therapy)|29 participants out of 30 participants were evaluable for this outcome measure.||participants|||Number
680698|NCT01566435|Secondary|Number of Participants Per Anatomic Tumor Response by CT Scan|"Response assessed using RECIST criteria version 1.0
Complete response: disappearance of all target lesions
Partial response: at least 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter
Non-complete response/non-progression: persistence of one or more non-target lesion and/or maintenance of tumor marker level above the upper limits of normal.
Progression: at least a 20% increase in the sum of the LD of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions."|6 weeks (2 cycles of therapy)|||participants|||Number
680699|NCT01566435|Secondary|Percentage of Participants With Partial Response (PR) at Primary Tumor Site|"Response will be assessed by laryngoscopy.
PR: at least 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter"|6 weeks (2 cycles of therapy)|||percentage of participants|||Number
680700|NCT01566435|Primary|Percentage of Participants With Complete Response (CR) by Clinical Exam at Primary Tumor Site|"Response will be assessed by laryngoscopy.
CR: disappearance of all lesions"|6 weeks (2 cycles of therapy)|||percentage of participants|||Number
680701|NCT01566409|Secondary|Usage of Laxative||½ year||||||
680702|NCT01566409|Primary|Treatment Recovery|Recovery is defined as the child having no symptoms of constipation according to the Rome III criteria.|½ year|||participants|||Number
680703|NCT01566370|Secondary|Change in Number of Drinks Per Week by Time|Comparison between medication and placebo groups on the change in number of drinks per week via interaction with time (from baseline to endpoint) using repeated measures|14 weeks (baseline to endpoint)|None of the subjects completed the study or made it to the 12 week endpoint.|||||
680704|NCT01566370|Secondary|Change in Number of Heavy Drinking Days Per Week by Time|A comparison between medication and placebo on the measure of number heavy drinking days per week over the course of the study (baseline to endpoint) via interaction with time using repeated measures|14 weeks (baseline to endpoint)|None of the subjects completed the study or made it to the 12 week endpoint.|||||
680705|NCT01566370|Secondary|Percentage of Total Drinking Days|The percentage of total drinking days compared between groups (zonisamide and placebo) during the time spent on the target dose of the medication (i.e., not including the titration or taper periods), which includes week 11, 12, 13, and 14.|4 weeks|None of the subjects completed the study or made it to the 12 week endpoint.|||||
680706|NCT01566370|Secondary|Change in Beck Depression Inventory (BDI) Scores|Comparison between groups on change in BDI scores over the 14 weeks of the study, measured weekly, using repeated measures|14 weeks|None of the subjects completed the study or made it to the 12 week endpoint.|||||
680707|NCT01566370|Secondary|Change in Gamma Glutamyl Transferase (GGT)|Difference between groups on change in levels of GGT over time, measured at baseline, week 5, week 9, week 13, and endpoint, using repeated measures|14 weeks|None of the subjects completed the study or made it to the 12 week endpoint.|||||
680708|NCT01566370|Secondary|Change in Alcohol Urge Questionnaire Score|This is the change in AUQ scores (urge to drink) measured weekly compared between groups using repeated measures|from baseline to endpoint, 14 weeks|None of the subjects completed the study or made it to the 12 week endpoint.|||||
680709|NCT01566370|Secondary|Percentage of Abstinent Days|The difference in total percentage of abstinent compared between groups (zonisamide and placebo) during the time spent on the target dose of the medication (i.e., not including the titration or taper periods), which includes week 11, 12, 13, and 14.|over four weeks, from week 11 through 14|None of the subjects completed the study or made it to the 12 week endpoint.|||||
680710|NCT01566370|Primary|Change in Clinician Assisted Rating Scale for Mania (CARS-M) Scores|Comparison between groups on change in scores on the CARS-M over 14 weeks from baseline to endpoint, measured weekly and analyzed with repeated measures|14 weeks|None of the subjects completed the study or made it to the 12 week endpoint.|||||
680711|NCT01566370|Primary|Change on Hamilton Depression Rating Scale|Change from baseline to endpoint in Hamilton scores compared between medication and placebo, using repeated measures|14 weeks|None of the subjects completed the study or made it to the 12 week endpoint.|||||
680712|NCT01566370|Primary|Percentage of Total Heavy Drinking Days|The percentage of total heavy drinking days compared between groups (zonisamide and placebo) during the time spent on the target dose of the medication (i.e., not including the titration or taper periods), totaled between the time-points of weeks 11 and 14 (4 weeks time frame).|from week 11 through 14 (over 4 weeks)|None of the subjects completed the study or made it to the 12 week endpoint.|||||
680713|NCT01566331|Primary|Partecipant With Perineal Laceration|The following types of lacerations were recorded during delivery: cervical laceration; mild perineal lacerations (defined as 1-2 lacerations); severe perineal lacerations (defined as 3-4 lacerations)|after delivery|intervention in normal pregnancies at term during labor and delivery||participants|||Number
680714|NCT01566162|Secondary|Intent to Attend Assessment|The ITA assessment will be administered by a research staff member. The response is recorded on a 10-point scale, with 0 = “Not at all” and 9 = “Extremely”. The ITA allowed the site to capture data regarding dropout risk. The following question was completed at the baseline visit: “How likely is it that you will complete the study?”|12 weeks|Only 1825 subjects answered the questionnaire.||units on a scale||Standard Deviation|Mean
680715|NCT01566162|Secondary|Smoking Questionnaire|Smoking questionnaire - average number of cigarettes per day at week 12 (LOCF).|12 weeks|Only 36 subjects who were smokers had the smoker questionnaire assessments.||number of cigarettes smoked daily||Standard Deviation|Mean
680716|NCT01566162|Secondary|Brief Adherence Rating Scale (BARS)|The Brief Adherence Rating Scale (BARS) is a clinician-administered adherence assessment instrument that consists of four items including three questions and a visual analog rating scale (VAS) to assess the percentage (0 100%) of doses taken by the subject in the previous month.|12 weeks|||percentage of monthly doses taken||Standard Deviation|Mean
680717|NCT01566162|Secondary|Modified Specific Levels of Functioning (SLOF) Total Score.|The modified SLOF scale is designed to measure directly observable behavioral functioning and daily living skills of patients with chronic mental illness. The modified SLOF consists of 24 items, each item is rated on a 5-point scale and mapped to 0 to 4. The total score will be the sum of all 24 items and ranges from 0 to 96. A higher score indicates worse condition.|12 weeks|Only 174 subjects had SLOF assessments at week 12 LOCF.||units on a scale||Standard Deviation|Mean
680718|NCT01566162|Secondary|Short Form-12 Health Survey (SF-12)|The SF-12v2 is a self-administered, multipurpose short-form (SF) generic measure of health status. It was developed to be a shorter, yet valid, alternative to the SF-36 for use in large surveys of general and specific populations as well as in large longitudinal studies of health outcomes. The 12 items in the SF-12v2 are a subset of those in the SF-36; SF-12v2 includes one or two items from each of the eight health concepts with higher scores indicative of higher functioning and better health. The Physical Component Score is a composite of the Physical Functioning, Role Functioning, Bodily Pain and General Health scales. Physical Composite Scores (PCS) is computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.|Baseline to week 12 LOCF endpoint|Only 182 subjects had post-baseline SF-12.v2 assessments.||units on a scale||Standard Deviation|Mean
680719|NCT01566162|Secondary|Change From Baseline in Montgomery -Asberg Depression Rating Scale Total Score|The MADRS consists of 10 items, each rated on a Likert scale, from 0=”Normal” to 6=”Most Severe”. The MADRS total score is calculated as the sum of the 10 items. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity.|Baseline to week 12 LOCF endpoint|Only 182 subjects had post-baseline MADRS assessments.||units on a scale||Standard Deviation|Mean
680720|NCT01566162|Primary|Efficacy - Change From Baseline in Clinical Global Impression-Severity of Illness (CGI-S) Score.|The CGI-S score is a single value, clinician-rated assessment of illness severity and ranges from 1= ‘Normal, not at all ill’ to 7= ‘Among the most extremely ill patients’. A higher score is associated with greater illness severity.|Baseline to week 12 LOCF endpoint|||units on a scale||Standard Deviation|Mean
680721|NCT01566162|Primary|Efficacy - Change in Positive and Negative Syndrome Scale (PANSS) Total Score|The PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity.|Baseline to week 12 LOCF endpoint|||units on a scale||Standard Deviation|Mean
680723|NCT01566149|Secondary|Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 12|Baseline was defined as the highest FEV1 value of three assessments prior to first dose of study drug. If two (or all three) spirometry efforts had identical FEV1, the FEV1 from the effort with the highest Forced Vital Capacity (FVC) was to be recorded. Week 12 FEV1 was assessed as the morning FEV1 at the end of the dosing interval (trough FEV1). For participants who discontinued prior to Week 12, the FEV1 measurement from the discontinuation visit was to be be carried forward to Week 12 if (and only if) the participant's study medication compliance rate prior to discontinuation was at least 85%.|Baseline and Week 12|The FAS population consisted of all participants assigned treatment who received at lease one dose of study medication and had at least one efficacy measurement post-dose.||liters||Standard Deviation|Mean
680724|NCT01566149|Primary|Number of Participants Who Discontinued From the Study Due to an AE|An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.|Up to Week 12|The FAS population consisted of all participants assigned treatment who received at lease one dose of study medication.||participants|||Number
680725|NCT01566149|Primary|Number of Participants With At Least One Serious AE|"A serious AE was defined as any untoward medical occurrence or effect that at
any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is a congenital anomaly or birth defect; and/or cancer."|Up to Week 14|The FAS population consisted of all participants assigned treatment who received at lease one dose of study medication.||participants|||Number
680726|NCT01566149|Primary|Number of Participants With At Least One Drug-Related AE|A drug-related AE was defined as any AE for which there is reasonable possibility of drug relationship as assessed by the Investigator.|Up to Week 14|The FAS population consisted of all participants assigned treatment who received at lease one dose of study medication.||participants|||Number
680727|NCT01566149|Primary|Number of Participants With At Least One Adverse Event (AE)|An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.|Up to Week 14|The Full Analysis Set (FAS) population consisted of all participants assigned treatment who received at lease one dose of study medication.||participants|||Number
680728|NCT01566084|Secondary|BH4 Bioavailability|Change in FMD following acute oral tetrahydrobiopterin (BH4) is measured at the end of 5 weeks of sodium condition (low and normal intake) as an index of BH4 bioavailability.|Immediately following acute administration of BH4 on Weeks 5 and 10|BH4 could not be administered to 3 participants due to canceled visits.||percentage dilation||Standard Deviation|Mean
680729|NCT01566084|Secondary|Vascular Oxidative Stress|Change in FMD following acute infusion of ascorbic acid (a dose known to scavenge superoxide) is measured at the end of 5 weeks of sodium condition (low and normal intake) as an index of vascular oxidative.|Immediately following acute infusion of ascorbic acid on Weeks 5 and 10|Ascorbic acid is missing in one participant due to a failed i.v.||percentage dilation||Standard Deviation|Mean
680730|NCT01566084|Primary|Improved Flow Mediated Dilation|FMD is analyzed at weeks 5 and 10 or after each condition in this cross-over study design. Subjects are randomly assigned to a low salt or normal salt condition for the first set of 5 weeks and then crossed over to the other condition for the second set of 5 weeks.|Week 5 (after first condition of low salt or normal salt), Week 10 (after second condition, opposite to first)|All subjects are analyzed under each condition because of the cross-over design.||percentage dilation||Standard Deviation|Mean
680731|NCT01565993|Secondary|Difficult to Place the Clip|The hemoclips which were incorrectly placed, mainly because the pedicles were very thick and/or short.|During endoscopic procedure was performed (between 2007 and 2010: period over which the study was conducted)||||||
680732|NCT01565993|Primary|The Number of Polyps With Complications After Polypectomy (The Total Complication Rate)|"In order to test the ability of prophylactic hemoclipping to prevent post-polypectomy bleeding, the investigators were required to register all the adverse events that occurred. These adverse events were called complications, despite their severity and clinical significance"|Between four and six weeks after the polypectomy, the patients were contacted by phone in order to confirm the absence of delayed bleeding|Based on an anticipated decrease of at least 12% in the rate of adverse bleeding events between the group A and the group B, there was an alpha error of 0.05 and a statistical power of 80% with a patient inclusion rate of 1:1. The number of polyps required is 146 per group. Using the Fleiss correction, the final number is 164 per group.||polyps|Participants||Number
680733|NCT01565980|Other Pre-specified|Baseline Values for All Measures.|Description of all measures are described elsewhere. Provided are the means and standard deviations for baseline comparisons.|Baseline.|||units on a scale||Standard Deviation|Mean
680734|NCT01565980|Other Pre-specified|Pittsburgh Sleep Symptom Questionnaire-Insomnia (PSSQ_I)|The PSSQ_I has 13 self rated questions. The first 5 items, used to determine sleep quality (presence; frequency of insomnia problems) are rated [0 = never to 5 = always, 5-7 days per week; (range 0-25)] and items 6 to 13 are aimed at identifying the degree of interference experienced from sleep impairment (rated 0=not at all to 4=extremely on Likert scale; range 0 - 32).|Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.|||units on a scale||Standard Error|Least Squares Mean
680735|NCT01565980|Other Pre-specified|Worry (Cancer-related and General)|"Both cancer-related and general worry were measured with 3 item scales. Cancer-related worry had three statements asking about level of worry related to diagnosis, treatment, and worry interference using a 1 = not at all to 5 = most or all the time scale, range 3-15. Items are summed. General worry used an abbreviated brief Penn State Worry questionnaire with 3 statements that measure how typical that statements are in describing the person. Uses a 3 item scale with 1 = not at all typical to 5 = very typical. the range is 3-15. Items are summed."|Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.|||units on a scale||Standard Error|Least Squares Mean
680747|NCT01565889|Secondary|Part B: Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse|"Viral breakthrough was defined as having confirmed detectable HCV RNA levels (HCV RNA > LLOQ) on treatment after having previously had undetectable HCV RNA levels (HCV RNA < LLOQ) while on treatment.
Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) at end of treatment, but did not achieve an SVR.
Data for this outcome measure were collected for participants in Part B only."|Posttreatment Weeks 4 and 24|Part B Full Analysis Set||percentage of participants|||Number
680736|NCT01565980|Other Pre-specified|Cancer Dyspnea Scale|"The cancer dyspnea scale (CDS) has 12 Likert scale items ( 1 = Not at all, 5 = Very much) that ask questions about breathlessness or difficulty in breathing during the past few days. The CDS has an overall score (range 0-42) and 3 subscales that measure the amount of effort with breathing, anxiety associated with breathing, and discomfort associated with breathing.
The 3 subscales are calculated by: 1) effort (items 4+6+8+10+12) – 5 [range 0 (no dyspnea effort)-20 (worst dyspnea effort)]; 2) anxiety (items 5+7+9+11) – 4 [range 0 (no dyspnea anxiety) - 16 (worst dyspnea anxiety)]; 3) discomfort [15 – (items 1+2+3) {range 0 (no dyspnea discomfort) - 12 (worst dyspnea discomfort)}]. The total dyspnea score is derived by adding the total subscale scores. The subscale score subtractions are to make adjustments for 0 as a state of absence of dyspnea (thus total dyspnea summary scores range from 0 to 42)."|Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.|||units on a scale||Standard Error|Least Squares Mean
680737|NCT01565980|Other Pre-specified|Center for Epidemiologic Studies Depression (CES-D)|The score is the sum of the 20 questions. Each item has a range of 1 - 4 for frequency of a behavior or mental state in the past week ; 1 - Rarely or none of the time (less than 1 day); 2 = Some or a little of the time (1-2 days); 3 = Occasionally or a moderate amount of time (3-4 days); 4 = Most or all of the time (5-7 days). Possible range is 0-60. There are 4 reverse-scored items (questions 4, 8, 12, and 16). A score of 16 points or more is considered depressed.|Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.|||units on a scale||Standard Error|Least Squares Mean
680738|NCT01565980|Primary|SF-36|Health-related Quality of Life (HRQOL) Indices (Physical/Emotional Function, Role Function, Pain, General Health, Vitality, Mental/Physical Health)HRQOL(SF-36) calculated using Quality Metric, Inc. an algorithm producing normal scores (1-100 range). With normed scoring, general population has mean=50, SD=10. For the minimum and maximum values in each of the scale ranges provided, higher values represent a better outcome.|Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.|Adjusted means of outcomes and standards error provided for T2 & 3, folllowed by summary of linear mixed effects models for the outcomes for group comparisons.||units on a scale||Standard Error|Least Squares Mean
680739|NCT01565980|Primary|M.D. Anderson Symptom Inventory (MDASI)|"Symptom Severity and interference were measured with the M.D. Anderson Symptom Inventory (MDASI) . The MDASI is a multisymptom patient-reported outcome measure. The MDASI has 13 core items include symptoms found to have the highest frequency and/or severity in patients with various cancers and treatment types (pain, fatigue, nausea, vomiting, disturbed sleep, distress, shortness of breath, memory difficulties, lack of appetite, drowsiness, dry mouth, sadness,numbness and tingling. Patients rate the severity of each symptom “at its worst” using 0–10 numerical rating scales with 0 = “not present” and 10 = “as bad as you can imagine.” The measure includes 5 symptom interference items which ask how much all symptoms, interfere with domains (walking, work, general activity, mood, relations with others, enjoyment of life) also rated on a 0-10 scale (0 = did not interfere; 10 = interfered completely). The 13 severity (range 0 - 130) and 5 interference items (range 0 - 50) are summed."|Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.|Adjusted means of outcomes and their standard errors are reported for times 2 and 3. The summary of linear mixed effects for group comparisons are then presented.||units on a scale||Standard Error|Least Squares Mean
680740|NCT01565902|Secondary|Number of Patients With Adverse Events, Serious Adverse Events and Death Adverse Events (Frequency of Adverse Events, Serious Adverse Events, and Notable Laboratory Abnormalities) of of BAF312 After a Single Dose of BAF312|Physical examination, vital signs, body temperature, standard safety laboratory evaluations (hematology, clinical chemistry, coagulation, Hepatitis B and C and HIV serology, α-fetoprotein [in hepatically impaired subjects only], pregnancy test, alcohol and drug screen), standard 12-lead electrocardiogram , cardiac monitoring, 24-h Holter ECG, suicidality assessment (C-SSRS), (serious) adverse event monitoring.|Day -1 to 22|The safety analysis set consists of all subjects that received study drug and with no protocol deviations with relevant impact on safety.||Participants|||Number
680741|NCT01565902|Primary|Pharmacokinetic Parameters of BAF312 and Selected Metabolites: Observed Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax)|The pharmacokinetics of BAF312 were studied in plasma up to 504 hours post-dose at the following time points: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, 216, 312, 408 and 504 hours post dose|pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, 216, 312, 408 and 504 hours post dose|The PK analysis set consists of all completed subjects with quantifiable pharmacokinetic (PK) measurements. To reduce the number of healthy subjects exposed to BAF312, study allowed matching of subjects with hepatic impairment to healthy subjects. A healthy subject served as matching partner for up to 3 subjects with hepatic impairment||(ng/mL)||Standard Deviation|Mean
680742|NCT01565902|Primary|Pharmacokinetic Parameters of BAF312 and Selected Metabolites: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast)|The pharmacokinetics of BAF312 were studied in plasma up to 504 hours post-dose at the following time points: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, 216, 312, 408 and 504 hours post dose.|pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, 216, 312, 408 and 504 hours post dose.|The PK analysis set consists of all completed subjects with quantifiable pharmacokinetic (PK) measurements. To reduce the number of healthy subjects exposed to BAF312, study allowed matching of subjects with hepatic impairment to healthy subjects. A healthy subject served as matching partner for up to 3 subjects with hepatic impairment||h*ng/mL||Standard Deviation|Mean
680743|NCT01565902|Primary|Pharmacokinetic Parameters of BAF312 and Selected Metabolites: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf)|The pharmacokinetics of BAF312 were studied in plasma up to 504 hours post-dose at the following time points: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, 216, 312, 408 and 504 hours post dose.|pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, 216, 312, 408 and 504 hours post dose.|The PK analysis set consists of all completed subjects with quantifiable pharmacokinetic (PK) measurements. To reduce the number of healthy subjects exposed to BAF312, study allowed matching of subjects with hepatic impairment to healthy subjects. A healthy subject served as matching partner for up to 3 subjects with hepatic impairment||h*ng/mL||Standard Deviation|Mean
682155|NCT01544309|Primary|Percent Change in Non-high-density Lipoprotein Cholesterol (HDL-C) Level||Baseline, and 12 months after administration|Participants in full analysis set (FAS) except the ones who had no HDL-C data at 12 months.||Percent change||Standard Deviation|Mean
680748|NCT01565889|Secondary|Part B: Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|"SVR4 and SVR24 was defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.
Data for this outcome measure were collected for participants in Part B only."|Posttreatment Weeks 4 and 24|Part B Full Analysis Set||percentage of participants|||Number
680749|NCT01565889|Primary|Part B: Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)|"SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.
Data for this outcome measure were collected for participants in Part B only."|Posttreatment Week 12|Part B Full Analysis Set: participants enrolled into Part B of the study and dosed with at least 1 dose of study drug(s)||percentage of participants|||Number
680750|NCT01565889|Primary|Part A: Plasma Pharmacokinetics of SOF, EFV, TFV, and FTC: Cmax at Day 7|"Cmax: maximum observed concentration of drug in plasma.
Data for this outcome measure were collected for participants in Part A only."|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 hours postdose|Participants in the PK Analysis Set with available data were included.||ng/mL||Standard Deviation|Mean
680751|NCT01565889|Primary|Part A: Plasma Pharmacokinetics of SOF, EFV, Tenofovir (TFV), and FTC: AUCtau at Day 7|"AUCtau: concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval).
Data for this outcome measure were collected for participants in Part A only."|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 hours postdose|"Pharmacokinetics (PK) Analysis Set: participants with evaluable PK profiles who enrolled into Part A of the study and received study drug.
Participants in the PK Analysis Set with available data were included."||h*ng/mL||Standard Deviation|Mean
680752|NCT01565850|Secondary|Change From Baseline in CD4+ Cell Count at Week 48||Baseline; Week 48|Participants in the Full Analysis Set with Week 48 data were analyzed.||cells/µL||Standard Deviation|Mean
680753|NCT01565850|Secondary|Change From Baseline in CD4+ Cell Count at Week 24||Baseline; Week 24|Participants in the Full Analysis Set with Week 24 data were analyzed.||cells/µL||Standard Deviation|Mean
680754|NCT01565850|Secondary|Change From Baseline in HIV-1 RNA at Week 48||Baseline; Week 48|Participants in the Full Analysis Set with Week 48 data were analyzed.||log10 copies/mL||Standard Deviation|Mean
680755|NCT01565850|Secondary|Change From Baseline in HIV-1 RNA at Week 24||Baseline; Week 24|Participants in the Full Analysis Set with Week 24 data were analyzed.||log10 copies/mL||Standard Deviation|Mean
680756|NCT01565850|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48|The snapshot algorithm was used which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Full Analysis Set||percentage of participants|||Number
680757|NCT01565850|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24|The snapshot algorithm was used which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 24|Full Analysis Set: participant who were randomized;enrolled and received at least one dose of study drug||percentage of participants|||Number
680758|NCT01565707|Secondary|Change From Baseline in Post Void Residual (PVR) Volume|Post Void Residual (PVR) Volume was assessed by ultrasonography or bladder scan.|Baseline and Week 12|The study analysis population for this endpoint consisted of the SAF.||mL||Standard Deviation|Least Squares Mean
680759|NCT01565707|Secondary|Number of Participants With Adverse Events (AEs)|A treatment emergent adverse event (TEAE) was defined as an AE that occurred after the first dose of study drug and within 7 days after last dose of study medication.|From the first dose of study drug until 7 days after last dose of study medication (13 weeks).|The study analysis for this endpoint consisted of the Safety Analysis Set (SAF), the SAF consisted of all patients who received at least 1 dose of double-blind study medication and for whom any safety data were reported after first dose of study drug.||participants|||Number
680760|NCT01565707|Secondary|Apparent Volume of Distribution (Vz/F) of Solifenacin|Pharmacokinetic sampling was performed at steady state at the end of treatment.|Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake).|The study analysis population for this endpoint consisted of the PKAS.||L||Standard Deviation|Mean
680761|NCT01565707|Secondary|Apparent Total Body Clearance (CL/F) of Solifenacin|Pharmacokinetic sampling was performed at steady state at the end of treatment.|Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake).|The study analysis population for this endpoint consisted of the PKAS.||L/h||Standard Deviation|Mean
680762|NCT01565707|Secondary|Apparent Terminal Elimination Half-Life (T1/2) of Solifenacin|Pharmacokinetic sampling was performed at steady state at the end of treatment.|Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake).|The study analysis population for this endpoint consisted of the PKAS.||hours||Standard Deviation|Mean
680763|NCT01565707|Secondary|Area Under the Plasma Concentration - Time to Curve (AUC) for a Dose Interval (AUCtau) of Solifenacin|Pharmacokinetic sampling was performed at steady state at the end of treatment.|Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake).|The study analysis population for this endpoint consisted of the PKAS.||ng*h/mL||Standard Deviation|Mean
680764|NCT01565707|Secondary|Plasma Concentration Before Drug Administration (Ctrough) of Solifenacin|Pharmacokinetic sampling was performed at steady state at the end of treatment. Ctrough could not be calculated for 2 children and 1 adolescent in the PKAS.|Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake).|The study analysis population for this endpoint consisted of the PKAS.||ng/mL||Standard Deviation|Mean
680765|NCT01565707|Secondary|Time to Attain Maximum Concentration (Tmax) of Solifenacin|Pharmacokinetic sampling was performed at steady state at the end of treatment. Tmax could not be calculated for 2 children and 1 adolescent in the PKAS.|Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake).|The study analysis population for this endpoint consisted of the PKAS.||hours||Standard Deviation|Mean
680766|NCT01565707|Secondary|Maximum Concentration (Cmax) of Solifenacin|Pharmacokinetic sampling was performed at steady state at the end of treatment. Cmax could not be calculated for 2 children and 1 adolescent in the Pharmacokinetic Analysis Set (PKAS).|Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake).|The study analysis population for this endpoint consisted of the PKAS. The PKAS consisted of the subset of the Safety Analysis Set (SAF) for which plasma concentration data were available to facilitate derivation of at least 1 pharmacokinetic parameter and for whom the time of last dose prior to sampling was known.||ng/mL||Standard Deviation|Mean
680767|NCT01565707|Secondary|Change From Baseline to End of Treatment in Mean Number of Grade 3 or 4 Urgency Episodes Per 24 Hours in Adolescents|Adolescent participants were asked to record the degree of urgency associated with each micturition and incontinence episode according to the Patient Perception of Intensity of Urgency Scale (PPIUS) scale (0 - no urgency, 1 - mild urgency, 2 - moderate urgency, 3 - severe urgency, 4 - urge incontinence). The mean number of grade 3 or 4 urgency episodes was determined using using diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit.|Baseline and Week 12|The study analysis population for this endpoint consisted of the FAS including participants for whom data were available (adolescents only). Missing values at EoT were imputed using the last observation carried forward (LOCF) method.||urgency episodes||Standard Error|Least Squares Mean
680768|NCT01565707|Secondary|Change From Baseline to End of Treatment in Mean Number of Nighttime Micturitions Per 24 Hours|The mean number of micturitions was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. A micturition is any voluntary urination, excluding episodes of incontinence. Nighttime is defined as the time between going to bed and waking up the following morning.|Baseline and Week 12|The study analysis population for this endpoint consisted of the FAS population. Missing values at EoT were imputed using the LOCF method.||nighttime micturitions||Standard Error|Least Squares Mean
680769|NCT01565707|Secondary|Change From Baseline to End of Treatment in Mean Number of Daytime Micturitions Per 24 Hours|The mean number of micturitions was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. A micturition is any voluntary urination, excluding episodes of incontinence. Daytime is defined as the time between waking up in the morning and going to bed later the same day.|Baseline and week 12|The study analysis population for this endpoint consisted of the FAS population. Missing values at EoT were imputed using the LOCF method.||daytime micturitions||Standard Error|Least Squares Mean
680770|NCT01565707|Secondary|Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours|The mean number of micturitions was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. A micturition is any voluntary urination, excluding episodes of incontinence.|Baseline and Week 12|The study analysis population for this endpoint consisted of the FAS population. Missing values at EoT were imputed using the LOCF method.||micturitions||Standard Error|Least Squares Mean
680771|NCT01565707|Secondary|Change From Baseline to End of Treatment in Mean Number of Dry (Incontinence-Free) Nighttimes Per 7 Days|The mean number of dry nights was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. An incontinence episode is defined as an episode with any involuntary loss of urine.|Baseline and Week 12|The study analysis population for this endpoint consisted of the FAS population. Missing values at EoT were imputed using the LOCF method.||Dry Nights||Standard Error|Least Squares Mean
680772|NCT01565707|Secondary|Change From Baseline to End of Treatment in Mean Number of Dry (Incontinence-Free) Days Per 7 Days|The mean number of dry days was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. An incontinence episode is defined as an episode with any involuntary loss of urine.|Baseline and Week 12|The study analysis population for this endpoint consisted of the FAS population. Missing values at EoT were imputed using the LOCF method.||Dry Days||Standard Error|Least Squares Mean
680773|NCT01565707|Secondary|Change From Baseline to End of Treatment in Mean Number of Nighttime Incontinence Episodes Per 24 Hours|The mean number of incontinence episodes was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. An incontinence episode is defined as an episode with any involuntary loss of urine. Nighttime is defined as the time between going to bed and waking up the following morning.|Baseline and Week 12|The study analysis population for this endpoint consisted of the FAS population. Missing values at EoT were imputed using the LOCF method.||nighttime incontinence episodes||Standard Error|Least Squares Mean
680774|NCT01565707|Secondary|Change From Baseline to End of Treatment in Mean Number of Daytime Incontinence Episodes Per 24 Hours|The mean number of incontinence episodes was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. An incontinence episode is defined as an episode with any involuntary loss of urine. Daytime is defined as the time between waking up in the morning and going to bed later the same day.|Baseline and Week 12|Full analysis set including patients for whom data were available. Missing values at EoT were imputed using the last observation carried forward (LOCF) method.||daytime incontinence episodes||Standard Error|Least Squares Mean
680775|NCT01565707|Secondary|Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours|An incontinence episode is defined as an episode with any involuntary loss of urine. The mean number of incontinence episodes was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit.|Baseline and Week 12|The study analysis population for this endpoint consisted of the FAS population. Missing values at EoT were imputed using the LOCF method.||incontinence episodes||Standard Error|Least Squares Mean
680790|NCT01565538|Secondary|Best Tumor Response|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|From the date of randomization, assessed every 6 weeks, until at least 12 months after randomization.|||participants|||Number
681627|NCT01553318|Secondary|Change From Baseline in Evoked Pain Score at Week 10|Change in evoked pain score from baseline to week 10 (scale range -20 to +20): interpretation= the more negative the value is, the larger the reduction in sensitivity to pressure pain stimuli|baseline and week 10|||units on a scale||Standard Deviation|Mean
680776|NCT01565707|Secondary|Change From Baseline to End of Treatment in Daytime Maximum Volume Voided (DMaxVV) Per Micturition|The mean daytime maximum volume voided (DMaxVV) was determined using the participant diary data recorded during two measuring days (i.e., those days when the participant recorded the volume of each micturition) in the 7 days prior to the Baseline and end of treatment visits. The daytime maximum volume voided (DMaxVV) is the largest (non-zero) volume recorded over both of the 2 measuring days in the diary. The first morning void is excluded from the calculation. Daytime is defined as the time between waking up in the morning and going to bed later the same day. A micturition is any voluntary urination, excluding episodes of incontinence.|Baseline and Week 12|The study analysis population for this endpoint consisted of the FAS population. Missing values at EoT were imputed using the LOCF method.||mL||Standard Error|Least Squares Mean
680777|NCT01565707|Primary|Change From Baseline to End of Treatment (EoT) in Mean Volume Voided (MVV) Per Micturition|The mean voided volume was calculated from the participant diary data recorded during two measuring days (i.e., those days when the participant recorded the volume of each micturition) in the 7 days prior to the baseline and end of treatment visits. The MVV is equal to the mean of the non-zero volumes recorded over the 2 measuring days. A micturition is any voluntary urination, excluding episodes of incontinence.|Baseline and Week 12|Full Analysis Set (FAS) consists of all randomized patients that took at least one dose of double-blind study medication after randomization and provided both valid baseline and post-baseline values for the primary efficacy endpoint. Missing values at EoT were imputed using the last observation carried forward (LOCF) method.||mL||Standard Error|Least Squares Mean
680778|NCT01565616|Post-Hoc|PROMIS-57 Scores Health Related Quality of Life|"Health related quality of life was measured with the 57 item Patient-Reported Outcomes Measurement Information System (PROMIS-57). The PROMIS-57 includes 8 domains of health. The domains of Anxiety, Depression, Fatigue, Pain Interference, Physical Function, Satisfaction with Social Role, and Sleep Disturbances each include 8 items. Respondents indicate the degree to which statements about specific health issues are problematic on a scale of 1 to 5 and responses are converted to a t-score metric. A score of 50 is the mean score for the general population in the United States, with a standard deviation of 10. Scores above 50 indicate the topic of the domain is being experienced more than average while scores below 50 mean that it is less than average.
The domain of Pain Intensity is measured with a single item asking participants to rate their average pain on a scale from 0 (no pain) to 10 (worst imaginable pain). The raw mean score is used."|Baseline, 1 year after transplant|This outcome measure compared quality of life scores one year post-HCT to baseline in the 17 participants who completed the surveys.||units on a scale||Standard Deviation|Mean
680779|NCT01565616|Secondary|Transplant Related Outcomes|Common transplant related complications were monitored as a secondary outcome measure of this study. These transplant related complications include hepatic veno-occlusive disease (VOD), idiopathic pneumonia syndrome (IPS), central nervous system (CNS) toxicity complications of posterior reversible encephalopathy syndrome (PRES), hemorrhage, and seizures, cytomegalovirus (CMV) infection, adenovirus infection, Epstein-Barr virus (EBV) infection, post-transplant lymphoproliferative disease (PTLD), and invasive fungal infection.|1 year after transplant|||Participants|||Count of Participants
680780|NCT01565616|Secondary|Time to Neutrophil and Platelet Engraftment|Time to neutrophil engraftment is defined as the first of 3 measurements on different days when the patient has an absolute neutrophil count of at least 500/µL after conditioning. Time to Platelet engraftment is defined as the first day of a minimum of 3 measurements on different days that the patient has achieved a platelet count > 50,000/µL, without receiving a platelet transfusion in the previous 7 days.|1 year after transplant|||Days||Full Range|Median
680781|NCT01565616|Secondary|Overall Survival|Overall survival is defined as survival with or without sickle cell disease after hematopoietic cell transplantation (HCT).|1 year after transplant|||Participants|||Count of Participants
680782|NCT01565616|Secondary|Chronic Graft Versus Host Disease (GVHD)|Chronic GVHD was graded according to the National Institutes of Health (NIH) consensus criteria Diagnosis and scoring the severity of chronic GVHD is determined by evaluating symptoms of the skin, nails, hair, mouth, eyes, genitalia, gastrointestinal tract, liver, lungs, muscles, fascia and joints, immune function as well as other symptoms such as ascites and neuropathy. Chronic GVHD is graded as mild, moderate or severe based on the number of organ sites impacted and the severity of symptoms.|1 year after transplant|||Participants|||Count of Participants
680783|NCT01565616|Secondary|Acute Graft Versus Host Disease (GVHD)|Acute GVHD was graded according to the Center for International Blood and Marrow Transplant Research (CIBMTR) consensus criteria. Clinical manifestations of acute GVHD include skin, liver, and gastrointestinal symptoms. Grading of acute GVHD is determined by size of maculopapular rash, bilirubin and stool output.|1 year after transplant|||Participants|||Count of Participants
680784|NCT01565616|Secondary|Graft Failure|Primary graft failure occurs when a transplant recipient does not achieve donor chimerism following a bone marrow transplant. Secondary graft failure occurs when graft fails after donor chimerism had initially occurred.|1 year after transplant|||Participants|||Count of Participants
680785|NCT01565616|Primary|Event -Free Survival Rate|Event-free survival is defined as stable donor erythropoiesis with no new clinical evidence of sickle cell disease. Primary or late graft rejection, disease recurrence, and death are considered events for this endpoint.|1 year after transplant|||Participants|||Count of Participants
680786|NCT01565564|Secondary|The Rate of Pregnancy-induced Hypertension.|Pregnancy-induced hypertension includes gestational hypertension and preeclampsia/eclampsia.|From enrolment at 24-28 gestational weeks till after delivery, an average of 12 weeks.|||participants|||Number
680787|NCT01565564|Primary|The Rate of Macrosomia.|Macrosomia is defined as birthweight ≥ 4000 gram.|At the time of birth.|||participants|||Number
680788|NCT01565551|Primary|Glasgow Outcome Scale Extended (GOSE)|The GOSE provides and overall measure of disability based on information on cognition, independence, employability, and social/community participation collected via structured interview. Individuals are described by one of the eight outcome categories: Dead (1); Vegetative State (2); Lower Severe Disability (3); Upper Severe Disability (4); Lower Moderate Disability (5); Upper Moderate Disability (6); Lower Good Recovery (7) and Upper Good Recovery (8). Good Recovery is defined as a score of 7-8, Moderate Disability is defined by a score of 5-6 and Severe Disability is defined by a score of 3-4.|6 Months Post-Injury|||Glasgow Outcome Scale Extended (GOSE)||Inter-Quartile Range|Median
680789|NCT01565538|Secondary|Overall Survival||From date of randomization until the date of death from any cause, assessed until at least 12 months after randomization.|||months||95% Confidence Interval|Median
680791|NCT01565538|Primary|Progression-Free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|From the date of randomization to the date of tumour progression or death from any cause, assessed until at least 12 months after randomization.|||months||95% Confidence Interval|Median
680792|NCT01565382|Secondary|Overall Inter-reader Agreement - Fleiss' Kappa|Seven readers blinded to all clinical information using the binary read methodology (amyloid positive/negative). Fleiss' kappa was calculated across all inter-reader comparisons.|50-60 min after injection|Seven private practice nuclear medicine physicians with no prior training in reading florbetapir-PET scans each rated 40 florbetapir-PET scans (7 readers x 40 scans = 280 scan reads)as either amyloid positive or negative.||Fleiss' kappa|Participants||Number
680793|NCT01565382|Primary|Inter-reader Agreement - Median Kappa Statistic|Seven readers blinded to all clinical information using the binary read methodology (amyloid positive/negative). Simple kappa statistics were calculated for each reader versus the other 6 readers. Primary outcome measure was the median kappa of each reader versus the other 6 readers.|50-60 min after injection|Seven private practice nuclear medicine physicians with no prior training in reading florbetapir-PET scans each rated 40 florbetapir-PET scans (7 readers x 40 scans = 280 scan reads)as either amyloid positive or negative.||median kappa|Participants||Number
680794|NCT01565369|Secondary|Inter-reader Agreement|Percentage of individual scan reads that agreed or disagreed with the majority read across nine readers|50-60 min after injection|315 scans = 35 subjects x 9 readers||percentage of scans|Participants||Number
680795|NCT01565369|Primary|Specificity of Florbetapir PET Scans to Detect Moderate to Frequent Amyloid Plaque|Nine readers blinded to all clinical information using the binary read methodology (amyloid positive/negative). Specificity will be calculated as the percent of true negatives (as determined by the reference standard, no or sparse amyloid plaque at autopsy) that are correctly identified as amyloid negative by the PET scan read. Reported as the median specificity of the nine readers.|50-60 min after injection|16 of the 35 subjects had none or sparse plaques at autopsy||percentage of true negatives||Full Range|Median
680796|NCT01565369|Primary|Sensitivity of Florbetapir PET Scans to Detect Moderate to Frequent Amyloid Plaque|Nine readers blinded to all clinical information using the binary read methodology (amyloid positive/negative). Sensitivity will be calculated as the percent of true positives (as determined by the reference standard, moderate or frequent amyloid plaque at autopsy) that are correctly identified as amyloid positive by the PET scan read. Reported as the median sensitivity of the nine readers.|50-60 min after injection|19 of the 35 subjects had moderate or frequent plaques at autopsy||percentage of true positives||Full Range|Median
680797|NCT01565356|Secondary|Agreement of Interpretation Between 30-40 and 50-60 Min Reads - Semi-quantitative Evaluation|Three independent readers blinded to subject identification, subject diagnosis, subject demographics and PET scan time points post-injection read each scan and reported the results using a 5-point scale (0=no amyloid; 4=high levels of amyloid deposition). Results are reported as a weighted kappa statistic.|Scans acquired 30-40 min and 50-60 min post-injection|||weighted kappa||95% Confidence Interval|Number
680798|NCT01565356|Primary|Percent Agreement of Interpretation Between 30-40 and 50-60 Min Reads - Qualitative Evaluation|Three independent readers blinded to subject identification, subject diagnosis, subject demographics and PET scan time points post-injection read each scan and reported as amyloid positive or amyloid negative. Results show the percentage of agreement between the majority read of 30-40 min scan and the majority read of the 50-60 min scan.|Scans acquired 30-40 min and 50-60 min after injection|||percentage of agreement|||Number
680799|NCT01565343|Primary|Mean Cortical to Cerebellum SUVR|Standardized Uptake Value ratio (SUVR) is the ratio of tracer uptake in predefined cortical regions, relative to uptake in the whole cerebellum.|50-70 min after injection|Due to poor subject positioning that resulted in an incomplete brain image on the retest image day, accurate quantitative analysis for one healthy control was not possible, and the subject was excluded from the SUVR-based analyses.||SUVR||Standard Deviation|Mean
680800|NCT01565330|Secondary|Mean Cortical to Cerebellum SUVR|Standardized Uptake Value ratio (SUVR) is the ratio of tracer uptake in predefined cortical regions, relative to uptake in the whole cerebellum.|0-90 min after injection|||SUVR||Standard Deviation|Mean
680801|NCT01565330|Primary|Florbetapir-PET Scan Quality|Visual evaluation of image quality by nuclear medicine specialist blinded to dose and clinical information; reported on a 5-point scale (5=excellent and 1=poor).|0-90 min after injection|One subject in the 370 MBq (10 mCi) AD Group did not complete all imaging time periods||florbetapir scans|||Number
680802|NCT01565291|Secondary|Precuneus to Cerebellum SUVR|Ratio of uptake in the precuneus to uptake in the cerebellum.|50-60 min after injection|4 subjects in AD group and 1 subject in the healthy elderly group were excluded due to poor placement and/or excessive movement in the scanner during the 200-minute procedure.||SUVR||Standard Deviation|Mean
680803|NCT01565291|Primary|Mean Cortical to Cerebellum SUVR|Standardized Uptake Value ratio (SUVR) is the ratio of tracer uptake in predefined cortical regions, relative to uptake in the cerebellum gray matter. Total scan length was 200 min.|50-60 min after injection|4 subjects in AD group and 1 subject in the healthy elderly group were excluded due to poor placement and/or excessive movement in the scanner during the 200-minute procedure.||SUVR||Standard Deviation|Mean
680804|NCT01565148|Secondary|Peak Plasma Concentration (Cmax)of iCo-007 After Multiple Injections|cmax|Baseline to month 12|The study was terminated prior to month 12. No data was collected and 0 participants were analyzed at month 12|||||
680805|NCT01565148|Secondary|Duration of iCo-007 Treatment Effect|treatment effect as measured by VA and OCY thickness|Baseline to month 12|The study was terminated prior to month 12. No data was collected and 0 participants were analyzed at month 12|||||
680806|NCT01565148|Secondary|Change in Retinal Thickness Measured|measured by OCT|Baseline to month 12|The study was terminated prior to month 12. No data was collected and 0 participants were analyzed at month 12|||||
680807|NCT01565148|Secondary|Change in Retinal Thickness Measured by OCT From Baseline to Month 8|Group 1|Baseline to month 8|Some participants opted out of the month 8 OCT.||microns||Standard Deviation|Mean
680808|NCT01565148|Secondary|Change in VA From Baseline to Month 12|The primary efficacy variable is the change in visual acuity (mean change in number of letters) from baseline to month 12|Baseline to month 12|The study was terminated prior to month 12. No data was collected and 0 participants were analyzed at month 12|||||
680809|NCT01565148|Secondary|Number of Participants in a Given Study Arm Experiencing the Same Drug-related Serious Adverse Event as a Measure of Safety and Tolerability|Safety of repeated iCo-007 intravitreal injections in treatment of subjects with Diabetic Macular Edema (DME) as monotherapy and in combination with ranibizumab or laser photocoagulation. Serious consideration will be given if 2 or more patients in a particular treatment arm experience the same drug-related serious adverse event;|Baseline to month 8|||Participants|||Count of Participants
680810|NCT01565148|Primary|Change in VA From Baseline to Month 8|The primary efficacy variable is the change in visual acuity (mean change in number of letters) from baseline to month 8|Baseline to month 8|The results are from the participants which completed the primary end point and for which the data is available.||Letters||Standard Deviation|Mean
680811|NCT01565083|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Breast (FACT-B) Questionnaire Score|FACT-B questionnaire is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures ranges from 0=‘Not at all’ to 4=‘Very much’. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, thereafter every 3 cycles from Cycle 3 to Cycle 45 (each cycle = 21 days)|ITT population. Here, 'Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.||units on a scale||Standard Deviation|Mean
680812|NCT01565083|Secondary|Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Questionnaire Visual Analogue Scale (VAS) Score|EQ-5D VAS: participant rated questionnaire to assess health-related quality of life (QoL) in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, thereafter every 3 cycles from Cycle 3 to Cycle 45 (each cycle = 21 days)|ITT population. Here, 'Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.||units on a scale||Standard Deviation|Mean
680813|NCT01565083|Secondary|Overall Survival (OS)|OS was defined as the time from first intake of any study medication to the date of death, regardless of the cause of death. Participants who were known to be alive at the time of the analysis were censored at the date of the last follow-up assessment. Participants without follow-up assessment were censored at the day of last study treatment, and participants with no post-baseline information were censored at the date of first study treatment plus 1 day. Participants who died due to any cause were considered as having an event. The median OS was estimated using Kaplan-Meier method. The 95% CI was computed using log-log transformation.|Baseline until death (up to approximately 3.5 years)|ITT population||months||95% Confidence Interval|Median
680814|NCT01565083|Secondary|Percentage of Participants Who Died From Any Cause|Percentage of participants who died due to any cause was reported.|Baseline until death (up to approximately 3.5 years)|ITT population||percentage of participants|||Number
680815|NCT01565083|Secondary|Time to Progression (TTP) as Assessed by Investigator According to RECIST v 1.1|TTP was defined as the time from first intake of any study medication until the first radio-graphically documented PD as assessed by investigator according to RECIST v1.1. Participants who did not have a radio-graphically documented PD and had died due to reason other than PD were censored on the last available tumor assessment prior to the death date. Participants with no baseline or no tumor assessment after the baseline visit were censored on the date of first study treatment. PD was defined as >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. Participants who had radio-graphically documented PD as assessed by investigator according to RECIST v1.1 were considered as having an event. The median TTP was estimated using Kaplan-Meier method. The 95% CI was computed using log-log transformation.|Baseline, every 3 cycles up to 36 months, and every 6 cycles thereafter if progression free after 36 months, 28 days after end of treatment, every 3 months thereafter (maximum up to approximately 3.5 years)|ITT population||months||95% Confidence Interval|Median
680816|NCT01565083|Secondary|Percentage of Participants With Disease Progression as Assessed by Investigator According to RECIST v1.1|PD was defined as >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. Percentage of participants with radio-graphically documented PD as assessed by investigator according to RECIST v1.1 was reported.|Baseline, every 3 cycles up to 36 months, and every 6 cycles thereafter if progression free after 36 months, 28 days after end of treatment, every 3 months thereafter (maximum up to approximately 3.5 years)|ITT population||percentage of participants|||Number
680817|NCT01565083|Secondary|Progression-free Survival (PFS) as Assessed by Investigator According to RECIST v 1.1|PFS was defined as the time from first intake of any study medication until the first radio-graphically documented PD as assessed by investigator according to RECIST v1.1 or death due to any cause, whichever occurred first. Participants with no PFS events were censored at the time of the last evaluable tumor assessment. Participants with no baseline or no tumor assessment after the baseline visit were censored on the date of first study treatment. PD: >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. Participants who had radio-graphically documented PD as assessed by investigator according to RECIST v1.1 or died due to any cause were considered as having an event. The median PFS was estimated using Kaplan-Meier method. The 95% CI was computed using log-log transformation.|Baseline, every 3 cycles up to 36 months, and every 6 cycles thereafter if progression free after 36 months, 28 days after end of treatment, every 3 months thereafter (maximum up to approximately 3.5 years)|ITT population||months||95% Confidence Interval|Median
680847|NCT01564732|Secondary|Quantitative Change in Hypertension|Systolic and Diastolic Blood Pressure will be measured over the scheduled visits and the change in preoperative and postoperative blood pressure will be determined. We will also assess the need for medications to treat hypertension before and after surgery.|36 months|Data not collected.|||||
680848|NCT01564732|Secondary|Quality of Life||36 months|data not collected|||||
680849|NCT01564732|Primary|Weight Loss||36 months|Data not collected.|||||
680818|NCT01565083|Secondary|Percentage of Participants With Disease Progression as Assessed by Investigator According to RECIST v1.1 or Death From Any Cause|PD was defined as >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. Percentage of participants with radio-graphically documented PD as assessed by investigator according to RECIST v1.1 or death due to any cause was reported.|Baseline, every 3 cycles up to 36 months, and every 6 cycles thereafter if progression free after 36 months, 28 days after end of treatment, every 3 months thereafter (maximum up to approximately 3.5 years)|ITT population||percentage of participants|||Number
680819|NCT01565083|Secondary|Duration of Response (DOR) as Assessed by Investigator According to RECIST v 1.1|DOR, in participants with a BOR of CR or PR, was defined as the period from the date of initial PR or CR until the date of PD or death from any cause. Participants with no documented PD or death after CR or PR were censored at the last date at which they were known to have had the CR or PR, respectively (regardless of the response at intermediate assessments). CR: the disappearance of all TLs and SA reduction to <10 mm for nodal TLs/ non-TLs. PR: >/=30% decrease in SD of TLs, taking as reference the baseline SD. Confirmation of response at 2 consecutive tumor assessments >/=4 weeks apart was required. PD: >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. The 95% CI was computed using log-log transformation.|Baseline, every 3 cycles up to 36 months, and every 6 cycles thereafter if progression free after 36 months, 28 days after end of treatment, every 3 months thereafter (maximum up to approximately 3.5 years)|ITT population. Only participants with a BOR of CR or PR and with measurable disease at baseline were included in the analysis.||months||95% Confidence Interval|Median
680820|NCT01565083|Secondary|Time to Response as Assessed by Investigator According to RECIST v 1.1|For participants with a BOR of CR or PR, time to response = (Date of first confirmed CR/PR - Date of first study treatment) + 1. For participants without a CR or PR, time to response = (Date of adequate last tumor assessment - Date of first study treatment) + 1. For participant with no tumor assessment (or if all assessments were progressive disease [PD]) the censoring day was set to date of first study treatment +1. CR: the disappearance of all TLs and SA reduction to <10 mm for nodal TLs/ non-TLs. PR: >/=30% decrease in SD of TLs, taking as reference the baseline SD. Confirmation of response at 2 consecutive tumor assessments >/=4 weeks apart was required. PD: >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. The 95% CI was computed using log-log transformation.|Baseline, every 3 cycles up to 36 months, and every 6 cycles thereafter if progression free after 36 months, 28 days after end of treatment, every 3 months thereafter (maximum up to approximately 3.5 years)|ITT population. Only participants with measurable disease at baseline were included in the analysis.||months||95% Confidence Interval|Median
680821|NCT01565083|Primary|Percentage of Participants With Best Overall Response (BOR) as Assessed by Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)|Tumor response was assessed by investigator according to RECIST v1.1. BOR was defined as percentage of participants with a confirmed complete response (CR) or partial response (PR). All measurable lesions up to a maximum of 2 lesions per organ and 5 lesions in total or pathological nodes (with short axis [SA] of at least (>/=) 15 millimeter [mm]) were identified as target lesions (TLs) and measured and recorded at baseline. A sum of diameters (longest for non-nodal lesions, SA for nodal lesions) for all TLs was calculated and reported as baseline sum of diameters (SD). All other lesions (or sites of disease) were identified as non-TLs. CR: disappearance of all TLs and SA reduction to less than (<) 10 mm for nodal TLs/ non-TLs. PR: >/=30 percent (%) decrease in SD of TLs, taking as reference baseline SD. Confirmation of response at 2 consecutive tumor assessments >/=4 weeks apart was required. The 95% confidence interval (CI) was computed using Clopper-Pearson approach.|Baseline, every 3 cycles up to 36 months, and every 6 cycles thereafter if progression free after 36 months, 28 days after end of treatment, every 3 months thereafter (maximum up to approximately 3.5 years)|ITT population. Only participants with measurable disease at baseline were included in the analysis.||percentage of participants||95% Confidence Interval|Number
680822|NCT01564953|Secondary|Quality of Life|Quality of life measured by Chronic Obstructive Pulmonary Disease Assesment Test. Minimum score was 0 (no symptoms) and maximum score was 40 (many symptoms).|One year|||units on a scale||Full Range|Mean
680823|NCT01564953|Secondary|Serum Calcium|Serum ionized calcium, in mmol/L|One year|||mmol/L||Standard Deviation|Mean
680824|NCT01564953|Secondary|Serum Magnesium|Serum magnesium in plasma, in mmol/L|One year|||mmol/L||Standard Deviation|Mean
680825|NCT01564953|Secondary|Lung Function Test|Forced expiratory ventilation in 1 second, in percent of predicted|one year|||percentage of predicted||Full Range|Mean
680826|NCT01564953|Primary|Serum Vitamin D|vitamin D measured by p-25-hydroxy-vitamin D2 + D3, in mmol/L|one year|||mmol/L||Standard Deviation|Mean
680827|NCT01564862|Secondary|Change From Baseline to Week 8 in the Clinical Global Impressions-Severity (CGI-S) Score|"The CGI-S assesses the clinician's impression of the subject's current state of mental illness and consists of one question for the investigator: Considering your total clinical experience with this particular population, how mentally ill is the patient at this time? which is rated on a seven-point scale (1=normal, not ill at all; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill). A MMRM model with baseline*week, center, week, treatment and week*treatment as factors was used for analyses."|Baseline, Week 1, Week 4 and Week 8|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug and had at least 1 valid post-baseline value for assessment of primary efficacy,with data available for analysis. Repeated Measures Analysis.||score on a scale||Standard Error|Least Squares Mean
680828|NCT01564862|Secondary|Percentage of Participants in MADRS Remission at Week 8|MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension) rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression) with a total possible score range from 0 to 60. Higher scores indicate greater severity of symptoms. MADRS Remission was defined as a MADRS total score ≤10.|Week 8|Full Analysis Set included all randomized participants who received at least one dose of study drug and had at least 1 valid post-baseline value for assessment of primary efficacy. Last Observation Carried Forward.||percentage of participants|||Number
680829|NCT01564862|Secondary|Percentage of Participants With MADRS Response at Week 8|MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension) rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression) with a total possible score range from 0 to 60. Higher scores indicate greater severity of symptoms. MADRS Response was defined as a ≥50% decrease in MADRS Total Score from Baseline.|Baseline and Week 8|Full Analysis Set included all randomized participants who received at least one dose of study drug and had at least 1 valid post-baseline value for assessment of primary efficacy. Last Observation Carried Forward.||percentage of participants|||Number
680830|NCT01564862|Secondary|Change From Baseline to Week 8 in the MADRS Total Score|MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension) rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression) with a total possible score range from 0 to 60. Higher scores indicate greater severity of symptoms. A negative change from Baseline indicates improvement.|Baseline, Week 1, Week 4 and Week 8|Full Analysis Set included all randomized participants who received at least one dose of study drug and had at least 1 valid post-baseline value for assessment of primary efficacy. Last Observation Carried Forward.||score on a scale||Standard Deviation|Mean
680831|NCT01564862|Secondary|Proportion of Cognitive Dysfunction Improvement Due to Improvement of Depression|Improvement of Cognitive Dysfunction is determined using the change from Baseline to Week 8 in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score and the Digital Symbol Substitution Test (DSST) total number of correct symbols. The MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension) rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression). The DSST assesses relative contributions of speed, memory, executive function and visual scanning. The proportion of direct effect from treatment = DSST difference / (DSST difference + coefficient*MADRS difference).|Baseline and Week 8|Full Analysis Set included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid post-baseline value for assessment.||proportion of direct effect|||Number
680832|NCT01564862|Secondary|Change From Baseline to Week 8 in the One-Back Task|The One-Back test measures the cognitive domain of attention and working memory through yes or no responses to 30 trials. The task requires participants to report when a stimulus item presented serially is the same as an item one step back from the item at hand for a total correct responses 0 to 100. It usually takes 2-3 minutes to be administered. Higher scores equal better performance. An increase in score over the course of the study indicates improved attention/working memory. An ANCOVA model was used with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Week 8|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analysis.||Log 10 milliseconds||Standard Error|Least Squares Mean
680833|NCT01564862|Secondary|Change From Baseline to Week 8 in the Identification Task (IT)|The IT measured choice reaction time: the participant pressed a “yes” button whenever an onscreen playing card turned face up and was red, or a “no” button if the card was not red. The IT took on average 2 minutes to complete. Lower scores equal better performance. A decrease in score over the course of the study indicates improved visual attention/vigilance. An ANCOVA model was used with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Week 8|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analysis.||Log10 milliseconds||Standard Error|Least Squares Mean
680834|NCT01564862|Secondary|Change From Baseline to Week 8 in the Detection Task (DT)|"The DT is a computerized test that measures simple reaction time and psychomotor speed. The task requires participants to respond by pressing a yes button as soon as an onscreen playing card is turned over and is red, and by pressing a no button if the card is not red. It takes 2 minutes to be administered. There is no minimum or maximum scores since it is a time-based assessment. Lower score equals better performance. A decrease in score over the course of the study indicates improved speed of processing and psychomotor function. An ANCOVA model was used with treatment and center as fixed factors and the Baseline value as a covariate."|Baseline and Week 8|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analysis.||Log10 milliseconds||Standard Error|Least Squares Mean
680835|NCT01564862|Secondary|Change From Baseline to Week 8 in the Groton Maze Learning Test (GMLT)|"The GMLT measures executive functioning and spatial problem solving. Participants learn a hidden pathway through a maze of 10 x 10 grid of tiles on a computer touch screen using step-by-step guess, with trial and error feedback after each step. Once the pathway is learned, participants repeat the same pathway four more times. It usually takes 5-6 minutes to administer this test. Lower score equals better performance. A decrease in score over the course of the study indicates improved executive function.
An ANCOVA model was used with treatment and center as fixed factors and the Baseline value as a covariate."|Baseline and Week 8|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analysis.||Errors||Standard Error|Least Squares Mean
680836|NCT01564862|Secondary|Change in Time From Baseline to Week 8 in the Stroop Test|The STROOP test assesses the ability to inhibit a prepotent response to reading words while performing a task that requires attention control. It comprises of 2 sheets with 50 words each, up to 50 correct responses for each of the congruent and incongruent Stroop tests. Participants have 4 minutes to name the ink color of each word. Lower time to complete the test indicates better performance. Higher number of correct responses indicates better responses. A decrease in the time to complete the tests and an increase in the number of correct responses both indicate improvement over the course of the study. An ANCOVA model was used with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Week 8|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analysis.||seconds||Standard Deviation|Mean
686531|NCT01489189|Secondary|Development of Central DME With Vision Impairment by 2-years||2-years|Excludes that did not have central DME with vision impairment (20/32 or worse) at baseline.||eyes|Eyes||Number
680837|NCT01564862|Secondary|Change From Baseline to Week 8 in the Trail Making Test B (TMT-B)|The TMT is a two-part cognitive test. TMT-B assesses executive functioning and consists of 25 circles distributed over a sheet of paper. Participants have 4 minutes to connect the circles as quickly as possible, without lifting the pen or pencil from the paper. Tester informs participant immediately whenever they make an error and allows for corrections by participants. Lower score for TMT-B represents better executive function. A decrease in score over the study represents an improvement in executive function. An ANCOVA model was used with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Week 8|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analysis.||seconds||Standard Error|Least Squares Mean
680838|NCT01564862|Secondary|Change From Baseline to Week 8 in the Trail Making Test (TMT-A)|The TMT is a two-part cognitive test. TMT-A assesses cognitive processing speed and consists of 25 circles distributed over a sheet of paper. Participants have 4 minutes to connect the circles as quickly as possible, without lifting the pen or pencil from the paper. Tester informs participant immediately whenever they make an error and allows for corrections by participants. Lower scores represent better speed of processing. A decrease in score over the study represents an improvement in speed in processing. An ANCOVA model was used with treatment and center as fixed factors and the baseline value as a covariate.|Baseline and Week 8|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analysis.||seconds||Standard Error|Least Squares Mean
680839|NCT01564862|Secondary|Clinical Global Impressions-Improvement (CGI-I) Score at Week 8|"The CGI-I assesses the clinician's impression of the subject's state of mental illness improvement and consists of one question for the investigator: Compared to his condition at the start of the study, how much has this patient changed? which is rated on a seven-point scale (1=very much improved; 2=much improved; 3=minimally improved; 4=no change relative to baseline; 5=minimally worse; 6= much worse; 7=very much worse). Higher scores indicate greater worsening of illness. Values closest to 1 for this outcome measure indicate the greatest improvement of symptoms. A MMRM model was used with baseline*week, center, week, treatment and week*treatment as factors in the analysis."|Baseline, Week 8|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analysis.||score on a scale||Standard Error|Least Squares Mean
680840|NCT01564862|Secondary|Change From Baseline to Week 8 in the Perceived Deficits Questionnaire (PDQ) Attention/Concentration and Planning/Organization Subscore|PDQ is a patient-rated scale designed to subjectively assess cognitive dysfunction, comprising four 5-item subscales: Attention/Concentration, Retrospective Memory, Prospective Memory, and Planning/Organization for a total possible score of 0 to 40. The subscale Attention/Concentration is the sum of items 1, 5, 9, 13, and 17 with a range of 0-20; while the subscale Planning/Organization is the sum of items 4, 8, 12, 16, and 20 with the score range of 0 to 20. The scores of the subscales Attention/Concentration and Planning/Organization were summed. Higher scores reflect greater participant-perceived cognitive dysfunction in the domains identified. A decrease in score represents an improvement in subjective cognitive function in the domains identified. A Mixed Model Repeated Measures (MMRM) model was used with baseline*week, center, week, treatment and week*treatment as factors in the analysis.|Baseline and Week 8|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug and had at least 1 valid post-baseline value for assessment of primary efficacy,with data available for analysis.||score on a scale||Standard Error|Least Squares Mean
680841|NCT01564862|Primary|Change From Baseline to Week 8 in the Digit Symbol Substitution Test (DSST)|The DSST assesses relative contributions of speed, memory, executive function and visual scanning. Participants are required to copy symbols that are paired with simple geometric shapes or numbers within a specific time for a total possible score of 0 to 133. Higher scores-correct number of symbols reflects greater objective cognitive functioning. An increase in score represents an improvement in an integrated measure of cognitive function. An Analysis of Covariance (ANCOVA) model was used with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Week 8|Full Analysis Set included all randomized participants who received at least one dose of study drug and had at least 1 valid post-baseline value for assessment of primary efficacy. Participants with scores of > 70 at Baseline were excluded.||Correct symbols||Standard Error|Least Squares Mean
680842|NCT01564758|Secondary|Number of Participants With Clinical Response|Clinical response assessed by Investigator at EOT visit as Cure: complete resolution of signs or symptoms of infection and no need to start another antibiotic. Improvement: incomplete resolution of signs or symptoms of infection but no need to start another antibiotic. Failure: death, or need to start another antibiotic. For participants previously assessed as failures, the outcome was failure at subsequent time points.|EOT (Day 10 up to 28)|Efficacy was evaluated for the safety analysis set which included all the participants who received at least 1 dose of study medication||participants|||Number
680843|NCT01564758|Primary|Number of Participants With Adverse Events (AEs)|Any untoward medical occurrence in a participant who received study treatment was considered an AE without regard to possibility of causal relationship.|Baseline up to End of Treatment (EOT) (Day 10 up to 28)|Safety analysis set included all the participants who received at least 1 dose of study medication.||participants|||Number
680844|NCT01564732|Secondary|Quantitative Change in Hypertriglyceridemia|Triglyceride levels will be measured annually for 3 years and the change in preoperative and postoperative levels will be determined. We will also assess the need for medications to treat hypertriglyceridemia before and after surgery.|36 months|Data not collected.|||||
680845|NCT01564732|Secondary|Quantitative Change in Hyperlipidemia|Lipid levels will be measured annually for 3 years and the change in preoperative and postoperative levels will be determined. We will also assess the need for medications to treat hyperlipidemia before and after surgery.|36 months|Data not collected.|||||
680846|NCT01564732|Secondary|Quantitative Change in Diabetes|Blood Sugar will be measured over the scheduled visits and the change in preoperative and postoperative glucose levels will be determined. We will also assess the need for medications to treat diabetes before and after surgery.|36 months|Data not collected|||||
680850|NCT01564706|Primary|Whole Body Radiation Dosimetry|Radiation dose values (millisieverts/megabecquerel [mSv/MBq]) for regions of the whole body. Target organs included the adrenals, brain, breasts, gall bladder wall, lower large intestine wall, small intestine wall, stomach wall, upper large intestine wall, heart wall, kidneys, liver, lungs, muscle, ovaries, pancreas, osteogenic cells, skin, spleen, testes, thymus, thyroid, urinary bladder wall, uterus, and total body.|0-380 min after injection|||mSv/MBq||Standard Deviation|Mean
680851|NCT01564693|Primary|ACTIVATION/NON ACTIVATION OF SPECIFIC BRAIN AREAS, EVALUATED BY FUNCTIONAL MAGNETIC RESONANCE|We observed different BOLD signal in the region of the hypothalamus between the 3 groups. The BOLD signal and the activation/no activation areas were statistically analyzed by a specific statistical method (i.e., parametric mapping).|TIME 0 (BASELINE)|||BOLD||Standard Deviation|Mean
680852|NCT01564537|Secondary|Association Between Response or Resistance to Ixazomib Treatment and Proteasome and Nuclear Factor–kB (NF-kB)-Related Genes||At the time of screening; Day 1 of each cycle; at EOT; every 4 weeks until disease progression and thereafter every 12 weeks until death or study termination||12/2020||||
680853|NCT01564537|Secondary|Pharmacokinetic Parameters (Including Cmax, AUC and Tmax) of Ixazomib||Days 1 & 14 of Cycles 1 & 2. Day 1 of Cycles 3 to 10||12/2020||||
680854|NCT01564537|Secondary|PFS in High-Risk Participants|Progression Free Survival (PFS) is defined as the time from the date of randomization to the date of first documentation of disease progression or death due to any cause, whichever occurs first. Response was assessed by independent review committee (IRC) using IMWG response criteria. High-risk participants are defined as participants carrying cytogenic abnormalities: del(17), translocation t(4;14), or t(14;16) as reported by the central laboratory combined with those cases that lacked a central laboratory result but with known del (17), t(4;14), or t(14;16) by local laboratory. Cytogenetic abnormalities of del(13) and +1q are no longer considered to be high-risk abnormalities and are not included in the analysis.|From date of randomization until disease progression or death up to data cut-off: 30 October 2014 (approximate median follow-up 15 months)|Participants from the ITT population, all randomized participants, with cytogenic abnormalities.||months||95% Confidence Interval|Median
680855|NCT01564537|Secondary|OS in High-Risk Participants|Overall survival (OS) is defined as the time from the date of randomization to the date of death. High-risk participants are defined as participants carrying cytogenic abnormalities: del(17), translocation t(4;14), or t(14;16) as reported by the central laboratory combined with those cases that lacked a central laboratory result but with known del (17), t(4;14), or t(14;16) by local laboratory. Cytogenetic abnormalities of del(13) and +1q are no longer considered to be high-risk abnormalities and are not included in the analysis. Participants without documentation of death at the time of the analysis were censored at the date when they were last known to be alive.|At the time of screening; Day 1 of each cycle; every 4 weeks until disease progression and thereafter every 12 weeks until death or study termination||12/2020||||
680856|NCT01564537|Secondary|Change From Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY-20)|The EORTC-QLQ-MY-20 is a patient-completed, 20-question quality of life questionnaire that has 4 independent subscales, 2 functional subscales (body image, future perspective), and 2 symptoms scales (disease symptoms and side-effects of treatment). The participant answers questions about their health during the past week using a 4-point scale where 1=Not at All to 4=Very Much. A negative change from Baseline indicates improvement.|Baseline and Every 2 Cycles beginning with Cycle 2 during treatment period, End of Treatment (EOT), and every 4 Weeks in follow-up||12/2020||||
680857|NCT01564537|Secondary|Change From Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) Questionnaire (EORTC-QLQ-C30)|The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer participants. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).The EORTC-QLQ-C30 Global Health Status/QOL Scale is scored between 0 and 100, where higher scores indicate better Global Health Status/QOL. Negative changes from baseline indicate deterioration in QOL or functioning and positive changes indicate improvement.|Baseline and Every 2 Cycles beginning with Cycle 2 during treatment period, End of Treatment (EOT), and every 4 Weeks in follow-up||12/2020||||
680858|NCT01564537|Secondary|Percentage of Participants Achieving Pain Response|Pain response was defined as 30% reduction from Baseline in Brief Pain Inventory-Short Form (BPI-SF) worst pain score over the last 24 hours without an increase in analgesic (oral morphine equivalents) use at 2 consecutive evaluations. The BPI-SF contains 15 items designed to capture the pain severity (“worst,” “least,” “average,” and “now” [current pain]), pain location, medication to relieve the pain, and the interference of pain with various daily activities including general activity, mood, walking activity, normal work, relations with other people, sleep, and enjoyment of life. The pain severity items are rated on a 0 to 10 scale where: 0=no pain and 10=pain as bad as you can imagine and averaged for a total score of 0 (best) to 10 (Worst).|At screening; Day 1 of each cycle; and thereafter every 4 weeks until disease progression||12/2020||||
680859|NCT01564537|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Eastern Cooperative Oncology Group (ECOG) performance score, laboratory values, vital sign measurements and reported adverse events (AEs) were collected and assessed to evaluate the safety of therapy throughout the study. An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event.|From the date of signing of the informed consent form through 30 days after the last dose of study drug up to data cut-off: 30 October 2014 (approximate median follow-up 15 months)|Safety population included all randomized participants who received at least 1 dose of ixazomib.||participants|||Number
680860|NCT01564537|Secondary|Time to Progression (TTP) as Assessed by the IRC|TTP was measured as the time in months from the first dose of study treatment to the date of the first documented progressive disease (PD) as assessed by the IRC using IMWG criteria.|Day 1 of each cycle (every 4 weeks) until disease progression up to data cut-off: 30 October 2014 (approximate median follow-up 15 months)|ITT population included all randomized participants||months||95% Confidence Interval|Median
680861|NCT01564537|Secondary|Duration of Response (DOR)|DOR was measured as the time in months from the date of first documentation of a confirmed response of PR or better (CR [including sCR] + PR+ VGPR) to the date of the first documented disease progression (PD) among participants who responded to the treatment. Response was assessed by the investigator using International Myeloma Working Group (IMWG) Criteria.|Day 1 of each cycle (every 4 weeks) until disease progression up to data cut-off: 30 October 2014 (approximate median follow-up 15 months)|Response-Evaluable population included all participants who received at least 1 dose of study drug, had measurable disease at baseline, and at least 1 post-baseline response assessment, all responders.||months||95% Confidence Interval|Median
680862|NCT01564537|Secondary|Percentage of Participants With Complete Response (CR) and Very Good Partial Response (VGPR) as Assessed by the IRC|Response was assessed by the IRC using International Myeloma Working Group (IMWG) Criteria. CR is defined as negative immunofixation on the serum and urine and; disappearance of any soft tissue plasmacytomas and; < 5% plasma cells in bone marrow. VGPR is defined as Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level < 100 mg per 24 hours.|Day 1 of each cycle (every 4 weeks) until disease progression up to data cut-off: 30 October 2014 (approximate median follow-up 15 months)|ITT population included all randomized participants.||percentage of participants|||Number
680863|NCT01564537|Secondary|Overall Response Rate (ORR) as Assessed by the IRC|ORR was defined as the percentage of participants with Complete Response (CR) including stringent complete response (sCR), very good partial response (VGPR) and Partial Response (PR) assessed by the IRC using IMWG criteria.|Day 1 of each cycle (every 4 weeks) until disease progression up to data cut-off: 30 October 2014 (approximate median follow-up 15 months)|ITT population included all randomized participants.||percentage of participants|||Number
680864|NCT01564537|Secondary|Overall Survival in High-Risk Participants Carrying Deletion 17 [Del(17)]|Overall survival is defined as the time from the date of randomization to the date of death. The high-risk participants whose myeloma carried del(17) subgroup was defined as the cases reported as positive for del(17) by the central laboratory combined with those cases that lacked a central laboratory result but with known del (17) by local laboratory. Participants without documentation of death at the time of the analysis were censored at the date when they were last known to be alive.|At the time of screening; Day 1 of each cycle (every 4 weeks) until disease progression and thereafter every 12 weeks until death or study termination||12/2020||||
680865|NCT01564537|Secondary|Overall Survival (OS)|Overall survival is defined as the time from the date of randomization to the date of death. Participants without documentation of death at the time of the analysis were censored at the date when they were last known to be alive.|Date of randomization until death up to data cut-off: 30 October 2014 (approximate median follow-up 15 months)|ITT population was defined as all randomized participants.||months||95% Confidence Interval|Median
680866|NCT01564537|Primary|Progression Free Survival (PFS) as Assessed by the Independent Review Committee (IRC)|Progression Free Survival (PFS) is defined as the time from the date of randomization to the date of first documentation of disease progression (PD) or death due to any cause, whichever occurs first. Response including PD was assessed by independent review committee (IRC) using the International Myeloma Working Group (IMWG) response criteria. PD requires 1 of the following: Increase of ≥ 25% from nadir in: Serum M-component (absolute increase ≥ 0.5 g/dl); Urine M-component (absolute increase ≥ 200 mg/24 hours); In patients without measurable serum and urine M-protein levels the difference between involved and uninvolved free light chain (FLC) levels (absolute increase > 10 mg/dl); Development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium > 11.5 mg/dl) attributed solely to plasma cell proliferative disease. Status evaluated every 4 weeks until disease progression (PD) was confirmed.|From date of randomization until disease progression or death up to data cut-off: 30 October 2014 (approximate median follow-up 15 months)|Intent-to-Treat (ITT) population was defined as all randomized participants.||months||95% Confidence Interval|Median
680867|NCT01564459|Primary|Percentage of Participants Who Were Discontinued Form the Study Due to an AE|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the drug. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an AE. Adverse Events that were reported as the cause for discontinuation of the study drug were recorded.|up to 7 days for run-in; up to 14 days for active treatment period)|All participants who received at least 1 dose of study drug. One participant who was randomly assigned to placebo for double-blind treatment period actually received MK-6096 10 mg. AEs are reported by treatment received and not by randomly assigned treatment arm.||Percentage of Participants|||Number
680868|NCT01564459|Primary|Percentage of Participants Who Experienced 1 or More Adverse Events (AE)|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the drug. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an AE.|up to 42 days (up to 14 days for run-in; up to 28 days for active treatment period)|All participants who received at least 1 dose of study drug. One participant who was randomly assigned to placebo for double-blind treatment period actually received MK-6096 10 mg. AEs are reported by treatment received and not by randomly assigned treatment arm.||Percentage of Participants|||Number
680881|NCT01564394|Primary|Attendance Rates in Study (Feasibility Outcome)|The class attendance rates were the number of classes attended by participants divided by the total number of classes offered. Range of attendance rate is 0 to 1. Prostate cancer survivors were the population targeted in this intervention, therefore, the retention and attendance rates only include prostate cancer survivors (i.e., family members were not included in these calculations).|13-weeks|||Proportion of classes|||Number
680869|NCT01564459|Secondary|Change in Pain Intensity Scores - All Responders|Participants rated their pain twice daily using a 0 to 10 scale with 0=no pain and 10=worst pain you can imagine. The participant’s average evening pain intensity scores over the last 3 days of screening period and of run-in period were defined as the run-in baseline score and treatment baseline score, respectively. A responder was defined as a participant who had a ≥20% decrease in treatment baseline score relative to run-in baseline score. The final value was the participant’s average evening pain intensity score over the last 3 days of treatment period. The change in the final average evening pain intensity score from treatment baseline was summarized for the responders.|End of Single-Blind Period (Baseline) and end of Double-Blind Period|All randomized participants (continued into double-blind treatment period) who met criteria as a responder.||Score on a scale||95% Confidence Interval|Least Squares Mean
680870|NCT01564459|Secondary|Change in Pain Intensity Scores - Primary Responders|Participants rated their pain twice daily using a 0 to 10 scale with 0=no pain and 10=worst pain you can imagine. The participant’s average evening pain intensity scores over the last 3 days of screening period and of run-in period were defined as the run-in baseline score and treatment baseline score, respectively. A primary responder was defined as a participant who had a ≥30% decrease in treatment baseline score relative to run-in baseline score. The final value was the participant’s average evening pain intensity score over the last 3 days of treatment period. The change in the final average evening pain intensity score from treatment baseline was summarized for the primary responders.|End of Single-Blind Period (Baseline) and end of Double-Blind Period|All randomized participants (continued into double-blind treatment period) who met criteria as a primary responder.||Score on a Scale||95% Confidence Interval|Least Squares Mean
680871|NCT01564459|Secondary|TTEF - All Responders|Participants rated their pain twice daily using a 0 to 10 scale with 0=no pain and 10=worst pain you can imagine. The participant’s average evening pain intensity scores over the last 3 days of screening period and of run-in period were defined as the run-in baseline score and treatment baseline score, respectively. A responder was defined as a participant who had a ≥20% decrease in treatment baseline score relative to run-in baseline score. Efficacy failure was defined as an occurrence of 3 consecutive days, or 4 days in a row with only one day missing and the other 3 days with a daily evening pain intensity score ≥4 and an increase of ≥20% in daily evening pain intensity score relative to treatment baseline score. The time to efficacy failure for responders was summarized.|Day 1 of double-blind treatment phase to the first documented efficacy failure (up to 28 days)|All randomized participants (continued into double-blind treatment period) who met criteria as a responder.||Days||95% Confidence Interval|Median
680872|NCT01564459|Primary|Time to Efficacy Failure (TTEF) - Primary Responders|Participants rated their pain twice daily using a 0 to 10 scale with 0=no pain and 10=worst pain you can imagine. The participant’s average evening pain intensity scores over the last 3 days of screening period and of run-in period were defined as the run-in baseline score and treatment baseline score, respectively. A primary responder was defined as a participant who had a ≥30% decrease in treatment baseline score relative to run-in baseline score. Efficacy failure was defined as an occurrence of 3 consecutive days, or 4 days in a row with only one day missing and the other 3 days with a daily evening pain intensity score ≥4 and an increase of ≥30% in daily evening pain intensity score relative to treatment baseline score. The time to efficacy failure for primary responders was summarized.|Day 1 of double-blind treatment phase to the first documented efficacy failure (up to 28 days)|All randomized participants (continued into double-blind treatment period) who met criteria as a primary responder.||Days||95% Confidence Interval|Median
680873|NCT01564407|Secondary|Quality of Life Measurement - Satisfaction With Appearance Scale (SWAP)|SWAP is a psychological test for personality diagnosis. there are 9 questions evaluated by a score of 7 (most descriptive to the patient) to 0 (not descriptive or irrelevant) for a total scoring range of 0-63.|12 weeks|||units on a scale||Standard Deviation|Mean
680874|NCT01564407|Secondary|Disability Index-Disability of Arm, Shoulder and Hand|The six subjects suffering from upper extremity and cervical scar contractures were evaluated with the Disability of Arm, Shoulder and Hand (DASH) questionnaire. The DASH questionnaire evaluates symptoms and functional status. A lowest score of 0 indicates normal skin and highest score of 100 represents the greatest possible morbidity.|12 weeks|||scores on a scale||Standard Deviation|Mean
680875|NCT01564407|Secondary|Patient and Observer Scar Assessment Scale (POSAS)|POSAS aims to measure scar quality, it is a comprehensive scale designed for the evaluation of all types of scars by professionals and patients. It contains two scales with six items, scored numerically from 0-10, where 0 is normal skin and 10 is the worst scar imaginable. the total scoring range is from 0-120.|12 weeks|||scores on a scale||Standard Deviation|Mean
680876|NCT01564407|Secondary|Vancouver Scar Scale|Vancouver scar scale will be evaluated for each cohort. The Vancouver scar scale is the most frequently cited assessment of scar severity used in clinical studies. Pigmentation, vascularity, pliability, and scar height are graded producing a composite score. A score of 0 represents normal skin with higher grades representing greater deformity with a maximum possible rating of 14.|12 weeks|||scores on a scale||Standard Deviation|Mean
680877|NCT01564407|Secondary|Percentage of Subjects Worse Hypertrophic Scars|The secondary objectives of this study are to evaluate improvement in symptoms of hypertrophic scars.|Endpoints assessed at Day 84.|||percentage of paricipants|||Number
680878|NCT01564407|Primary|Number of Participants With Serious Adverse Events Reported|The evaluation of tolerability of ICX-RHY-013 in the treatment of stable, restrictive hypertrophic scars through regular assessment of adverse events.|12 weeks|||participants|||Number
680879|NCT01564407|Primary|Number of Participants With Adverse Events|The evaluation of safety of ICX-RHY-013 in the treatment of stable, restrictive hypertrophic scars through assessment of adverse events. The primary objective of the safety (no injection) cohort is to evaluate initial safety of multiple doses through assessment of adverse events. The primary objective of remaining cohorts is to evaluate the ongoing safety of ICX-RHY-013 in post-burn hypertrophic scars that are not planned for excision through assessment of adverse events.|Days 0, 7, 14, 28, 56, 84|||participants|||Number
680880|NCT01564394|Primary|FACIT-Fatigue Change From Baseline to 13-weeks.|Our primary outcome of change in fatigue was assessed with the Functional Assessment Chronic Illness Therapy (FACIT)-Fatigue scale. This 13-item scale assesses levels of fatigue during daily activities over the past seven days. Higher scores indicate less fatigue (score range = 0 - 52). Positive change scores indicate improved fatigue.|Baseline to 13-weeks|Data is presented for Qigong participants (n=16) and family members (n=8 ) and for Stretching participants (n=13) and family members (n=7) .||Units on scale||Inter-Quartile Range|Median
680882|NCT01564394|Primary|Retention Rate in Study (Feasibility Outcome)|The retention rate was the proportion of participants who remained enrolled in the study and completed post-intervention measures. Range of retention rate is 0 to 1. Prostate cancer survivors were the population targeted in this intervention, therefore, the retention and attendance rates only include prostate cancer survivors (i.e., family members were not included in these calculations).|13-weeks|||proportion of participants|||Number
680883|NCT01564394|Secondary|Brief Symptom Inventory (BSI)-18 Change From Baseline to 13-weeks|The BSI-18 assesses global distress and three subscales (anxiety, depression, & somatization). Scores are converted to T-scores based on US population norms. Negative change scores indicate improvement in distress. We report data separately for prostate cancer survivors and family members. Based on the population norm a T-score of 63 or above indicates heightened global distress.|Baseline to 13-weeks|Data is presented for Qigong participants (n=16) and family members (n=8 ) and for Stretching participants (n=13) and family members (n=7) .||T-Score||Inter-Quartile Range|Median
680884|NCT01563978|Secondary|DAS28-CRP Improvement|ANCOVA=analysis of covariance, BID=twice daily, DAS28-CRP=Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (C-reactive protein [CRP]) and the patient’s own assessment, FAS=full analysis set, IP=investigational product. Scores can take any positive value with a lower value indicative of a better clinical condition. Mean changes from baseline in DAS28-CRP score are shown at each visit and are presented as decreases from baseline (defined as baseline minus post-baseline) with larger changes indicating a better clinical condition.|4 weeks|The FAS includes those randomised patients who received at least 1 dose of IP. Patients were analysed by randomised treatment in accordance with the intention to treat principle. The analysis population for each endpoint includes those patients from the FAS who were still on IP at 4 weeks and had a valid measurement for this type of assessment.||Units on a scale||Standard Deviation|Mean
680885|NCT01563978|Secondary|Mean Change From Completion/Discontinuation to Follow-up in Clinical Measurement of SBP and DBP|BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.|Day 29 to Day 36|The FAS includes those randomised patients who received at least 1 dose of IP. Patients were analysed by randomised treatment in accordance with the intention to treat principle. The analysis population for each endpoint includes patients from the FAS still on IP at Day 36 and with a valid measurement for this type of blood pressure assessment.||mmHg||Standard Deviation|Mean
680886|NCT01563978|Secondary|Mean Change From Baseline in Evening Post-dose Home SBP and DBP|ANCOVA=analysis of covariance, BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.|4 weeks|The FAS includes those randomised patients who received at least 1 dose of IP. Patients were analysed by randomised treatment in accordance with the intention to treat principle.The analysis population for each endpoint includes patients from the FAS still on IP at 4 weeks and with a valid measurement for this type of blood pressure assessment.||mmHg||Standard Deviation|Mean
680887|NCT01563978|Secondary|Mean Change From Baseline in Morning Pre-dose Home SBP and DBP|ANCOVA=analysis of covariance, BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.|4 weeks|The FAS includes those randomised patients who received at least 1 dose of IP. Patients were analysed by randomised treatment in accordance with the intention to treat principle.The analysis population for each endpoint includes patients from the FAS still on IP at 4 weeks and with a valid measurement for this type of blood pressure assessment.||mmHg||Standard Deviation|Mean
680888|NCT01563978|Secondary|Mean Change From Baseline in Clinic SBP and DBP|Blood pressure was measured in the clinic using an automated blood pressure machine (oscillometric method). Three separate measurements were taken 2 to 5 minutes apart and the mean of the 2nd and 3rd measurements calculated. ANCOVA=analysis of covariance, BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.|4 weeks|The FAS includes those randomised patients who received at least 1 dose of IP. Patients were analysed by randomised treatment in accordance with the intention to treat principle.The analysis population for each endpoint includes patients from the FAS still on IP at 4 weeks and with a valid measurement for this type of blood pressure assessment.||mmHg||Standard Deviation|Mean
680889|NCT01563978|Secondary|Change From Baseline in Mean Sleeping SBP and DBP by Ambulatory Blood Pressure Monitoring|ANCOVA=analysis of covariance, BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.|4 weeks|The FAS includes those randomised patients who received at least 1 dose of IP. Patients were analysed by randomised treatment in accordance with the intention to treat principle.The analysis population for each endpoint includes patients from the FAS still on IP at 4 weeks and with a valid measurement for this type of blood pressure assessment.||mmHg||Standard Deviation|Mean
680890|NCT01563978|Secondary|Change From Baseline in Mean Awake SBP and DBP by Ambulatory Blood Pressure Monitoring|ANCOVA=analysis of covariance, BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.|4 weeks|The FAS includes those randomised patients who received at least 1 dose of IP. Patients were analysed by randomised treatment in accordance with the intention to treat principle.The analysis population for each endpoint includes patients from the FAS still on IP at 4 weeks and with a valid measurement for this type of blood pressure assessment.||mmHg||Standard Deviation|Mean
680891|NCT01563978|Secondary|Change From Baseline in Mean Daytime and Night-time SBP and DBP by Ambulatory Blood Pressure Monitoring|ANCOVA=analysis of covariance, BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.|4 weeks|The FAS includes those randomised patients who received at least 1 dose of IP. Patients were analysed by randomised treatment in accordance with the intention to treat principle.The analysis population for each endpoint includes patients from the FAS still on IP at 4 weeks and with a valid measurement for this type of blood pressure assessment.||mmHg||Standard Deviation|Mean
680892|NCT01563978|Secondary|Change From Baseline in 24-hour Mean Ambulatory DBP|ANCOVA=analysis of covariance, BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product.|4 weeks|The FAS includes those randomised patients who received at least 1 dose of IP. Patients were analysed by randomised treatment in accordance with the intention to treat principle.The analysis population for each endpoint includes patients from the FAS still on IP at 4 weeks and had a valid measurement for this type of blood pressure assessment.||mmHg||Standard Deviation|Mean
680893|NCT01563978|Primary|Change From Baseline in 24-hour Mean Ambulatory SBP|ANCOVA=analysis of covariance, BID=twice daily, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.|4 weeks|The FAS includes those randomised patients who received at least 1 dose of IP. Patients were analysed by randomised treatment in accordance with the intention to treat principle.The analysis population for each endpoint includes patients from the FAS still on IP at 4 weeks and with a valid measurement for this type of blood pressure assessment.||mmHg||Standard Deviation|Mean
680894|NCT01563536|Other Pre-specified|Resistance-Associated Variants and Phenotypic Resistance|Baseline (pre-dose on Day 1) samples were analyzed for resistance-associated amino acid (AA) variants using population sequencing. Phenotypic resistance to ABT-267 at Baseline was assessed by calculating the fold difference in the the half maximal effective concentration (EC50) compared with the EC50 for the appropriate reference replicon (1a-H77 or 1b-Con1). Day 3 samples were analyzed using population sequencing and were compared with the baseline and appropriate prototypic reference sequences to assess AA changes. Phenotypic resistance at Day 3 was assessed by calculating the fold difference in the EC50 compared with the EC50 for the corresponding Baseline sample. The number of participants with variants at resistance-associated AA positions and phenotypic resistance at Baseline and Day 3 are presented.|Day 1 Pre-dose (Baseline) and Day 3 Pre-dose|All participants who received at least one dose of study drug (ITT population) and had evaluable data were analyzed for baseline resistance-associated amino acid variants; the development of viral resistance was analyzed in all participants who received at least 1 dose of ABT-267 whose samples had sufficient viral titer to allow analysis.||participants|||Number
680895|NCT01563536|Primary|Mean Maximal Decrease From Baseline in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) During ABT-267 Monotherapy|The baseline value was the last measurement before the first dose of ABT-267 monotherapy (Day 1). The maximal decrease during monotherapy was the change from baseline to the lowest log10 IU/mL HCV RNA level any time from the first dose of ABT-267 on Day 1 to the last log10 HCV RNA level before the first dose of ABT-267 combination therapy (Study Day 3).|Pre-dose on Days 1, 2, and 3|All participants who received at least one dose of study drug (ITT population).||log10 IU/mL||Standard Error|Least Squares Mean
680896|NCT01563536|Secondary|Mean Change in Viral Load From Baseline to Pre-dose on Day 2 and Day 3 of ABT-267 Monotherapy|The relationship between ABT-267 dose, ABT-267 concentration, and response was analyzed as the change in viral load (measured as log10 IU/mL) from baseline (pre-dose on Day 1) to pre-dose on Days 2 and 3. Plasma concentrations of ABT-267 pre-dose on Days 2 and 3 are presented above in 4. Primary Outcome: Plasma Concentration of ABT-267 Pre-dose (Ctrough) on Day 2 and Day 3.|Predose on Days 1, 2, and 3|All participants who received at least one dose of study drug (ITT population).||log10 IU/mL||Standard Deviation|Mean
680897|NCT01563536|Secondary|Percentage of Participants With Extended Rapid Virologic Response|The percentage of participants with virologic response (plasma HCV RNA less than the lower limit of quantitation [< LLOQ]) at Weeks 4 through 12 of combination therapy.|Weeks 4 to 12|All participants who received at least one dose of study drug (ITT population); participants with missing data were counted as non-responders.||percentage of participants|||Number
680898|NCT01563536|Secondary|Percentage of Participants With End-of-Treatment Response|The percentage of participants with virologic response (plasma HCV RNA less than the lower limit of quantitation [< LLOQ]) at the end of combination therapy (12 weeks).|12 weeks|All participants who received at least one dose of study drug (ITT population); participants with missing data were counted as non-responders.||percentage of participants|||Number
680899|NCT01563536|Secondary|Percentage of Participants With Rapid Virologic Response|The percentage of participants with virologic response (plasma HCV RNA less than the lower limit of quantitation [< LLOQ]) after 4 weeks of combination therapy.|4 weeks|All participants who received at least one dose of study drug (ITT population); participants with missing data were counted as non-responders.||percentage of participants|||Number
680900|NCT01563536|Secondary|Percentage of Participants With Sustained Virologic Response 12 Weeks and 24 Weeks After Combination Therapy|The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 and 24 weeks after the last dose of combination study drug. The LLOQ for the assay was 25 IU/mL.|12 and 24 weeks after last dose of combination study drug|All participants who received at least one dose of study drug (ITT population); participants with missing data were counted as non-responders.||percentage of participants|||Number
680901|NCT01563536|Primary|Number of Participants With Adverse Events (AEs)|"An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment.
The investigator assessed the relationship of each AE to the use of direct-acting antiviral agents (DAAs), and rated the severity of each event as either: Mild: The AE was transient and easily tolerated by the participant; Moderate: The AE caused the participant discomfort and interrupted usual activities; Severe: The AE caused considerable interference with the participant's usual activities and could have been incapacitating or life-threatening.
A serious adverse event was any event that resulted in death, was life-threatening, resulted in hospitalization or prolongation of hospitalization, resulted in a congenital anomaly or persistent or significant disability or was any other important medical event requiring medical or surgical intervention."|All AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks).|All participants who received at least one dose of study drug (safety population).||participants|||Number
680902|NCT01563536|Primary|Plasma Concentration of ABT-267 Pre-dose (Ctrough) on Day 2 and Day 3|Blood samples were collected pre-dose on Day 2 (prior to second dose of ABT-267 monotherapy) and pre-dose on Day 3 (prior to first dose of combination therapy). The samples were analyzed for ABT-267 using validated analytical methods. Pre-dose plasma concentrations on Day 2 and Day 3 (Ctrough, measured in ng/mL) are reported.|Day 2 (pre-dose) and Day 3 (pre-dose)|All participants who received at least one dose of study drug (ITT population).||ng/mL||Standard Deviation|Mean
680915|NCT01563185|Secondary|Single Dose Pharmacokinetic Characteristics of DUEXIS in JIA Patients: Maximum Observed Concentration (Cmax)|Cmax was estimated for ibuprofen and famotidine. The PK parameters for ibuprofen and famotidine represent average Cmax values following a single oral dose of DUEXIS. Samples were collected pre-dose and at 0.5, 1, 2, 4, and 8 to 10 hours following study drug administration.|Pre-dose, and 0.5, 1, 2, 4, 8 hours post-dose|The initial 9 patients met the PK objective of the study (4 were in the single dose pharmacokinietic group, however, 1 of the patients was not evaluable, and all 9 were in the multiple dose pharmacokinetic group).||ug/mL||Standard Deviation|Mean
680903|NCT01563536|Primary|Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours (AUC[24]) of ABT-267 Following Monotherapy on Day 1|Blood samples were collected pre-dose (time 0) and at 2, 4, and 6 hours post-dose on Day 1 and pre-dose on Day 2 (ABT-267 monotherapy). The samples were analyzed for ABT-267 using validated analytical methods. Area under the plasma concentration-time curve from time 0 to 24 hours (AUC[24]; measured in ng multiplied by hour/mL) was estimated using noncompartmental analyses.|Day 1 (pre-dose [time 0] and at 2, 4, and 6 hours post-dose) and Day 2 (pre-dose)|All participants who received at least one dose of study drug (ITT population).||ng*hr/mL||Standard Deviation|Mean
680904|NCT01563536|Primary|Time of Maximum Plasma Concentration (Tmax) of ABT-267 Following Monotherapy on Day 1|Blood samples were collected pre-dose (time 0) and at 2, 4, and 6 hours post-dose on Day 1 and pre-dose on Day 2 (ABT-267 monotherapy). The samples were analyzed for ABT-267 using validated analytical methods. Time of maximum plasma concentration (Tmax; measured in hours) was estimated using noncompartmental analyses.|Day 1 (pre-dose [time 0] and at 2, 4, and 6 hours post-dose) and Day 2 (pre-dose)|All participants who received at least one dose of study drug (ITT population).||hours||Standard Deviation|Mean
680905|NCT01563536|Primary|Maximum Plasma Concentration (Cmax) of ABT-267 Following Monotherapy on Day 1|Blood samples were collected pre-dose (time 0) and at 2, 4, and 6 hours post-dose on Day 1 and pre-dose on Day 2 (ABT-267 monotherapy). The samples were analyzed for ABT-267 using validated analytical methods. Maximum plasma concentration (Cmax; measured in ng/mL) was estimated using noncompartmental analyses.|Day 1 (pre-dose [time 0] and at 2, 4, and 6 hours post-dose) and Day 2 (pre-dose)|All participants who received at least one dose of study drug (intent-to-treat [ITT] population).||ng/mL||Standard Deviation|Mean
680906|NCT01563406|Secondary|Median Number of Microbial Colony Forming Units Per Hub Interior|This will be a quantitative outcome. It will be reported as the median number of microbial colony forming units isolated per hub interior. The median number of microbial colony forming units isolated per hub interior will be compared for the four study arms.|15 months|||colony forming units (CFU) per hub|Participants|Inter-Quartile Range|Median
680907|NCT01563406|Secondary|Number of Contaminated Central Venous Catheter Tips|"This will be a qualitative measure for central venous catheter tip contamination. The results will be reported as yes or no."|10 months|Unable to collect a sufficient number of catheter tips to analyze. Therefore, this outcome was dropped early in the study.|||||
680908|NCT01563406|Primary|Number of Central Venous Catheter Hubs With Internal Contamination|"This will be a qualitative outcome. It will be reported as yes or no for central venous catheter hub internal contamination. The number of hubs with internal contamination will be compared for the four study arms."|15 months|140 participants were recruited through 149 separate medical intensive care unit (MICU) admissions. Each MICU admission is treated as a separate enrollment.||contaminated hubs|Participants||Number
680909|NCT01563198|Secondary|Change in No-Show Rates of Patients From the Average of the Baseline Year to the Average of One Year Post Training|The sites will be followed for an average of one year after training in Comfort Talk and no-show rates will be compared to the baseline values of non-completion among all scheduled patients which were also collected over 1 year.|Baseline average of one year plus post training average one year = 2 years|Participants were from MRI 3 sites whose teams were trained in Comfort Talk®. In this analysis all patients who were scheduled for scans during the baseline year and the year after training were included.||Percentage of participants|||Number
680910|NCT01563198|Primary|Change in Non-completion Rate of MRI Scans From the Average of the Baseline Year to the Average of One Year Post Training (Showing-Up Patients Only)|The change in non-completion rate of MRI scans, obtained for the year prior to Comfort Talk® training at baseline, to the average one year post training was assessed|Baseline average of one year plus post training average one year = 2 years|Participants were from 3 MRI sites whose teams were trained in Comfort Talk®. In this analysis only patients who showed up at the MRI sites at baseline year and the year after training were included (all participants minus no-shows).||Percentage of showing-up participants|||Number
680911|NCT01563198|Primary|Change in Non-completion Rate of MRI Scans From the Average of the Baseline Year to the Average of One Year Post Training (All Scheduled Patients)|The sites will be followed for an average of one year after training in Comfort Talk and non-completion rates will be compared to the baseline values of non-completion among all scheduled patients.|Baseline average of one year plus post training average one year = 2 years|Participants were from MRI 3 sites whose teams were trained in Comfort Talk®. In this analysis all patients who were scheduled for scans during the baseline year and the year after training were included||Percentage of participants|||Number
680912|NCT01563185|Secondary|Multiple Dose Pharmacokinetic Characteristics of DUEXIS in JIA Patients: Volume Distribution (V/F)|V/F were estimated in ibuprofen and famotidine.|Pre-dose and 0.5, 1, 2, 4, and 8 hours post-dose in the single dose group; sparse samples at random times in the multiple dose group|||L/70 kg||Standard Deviation|Mean
680913|NCT01563185|Secondary|Multiple Dose Pharmacokinetic Characteristics of DUEXIS in JIA Patients: Individual Oral Clearance (CL/F)|CL/F was estimated in ibuprofen and famotidine.|Pre-dose and 0.5, 1, 2, 4, and 8 hours post-dose in the single dose group; sparse samples at random times in the multiple dose group|The initial 9 patients met the PK objective of the study (4 were in the single dose pharmacokinietic group, however, 1 of the patients was not evaluable and all 9 were in the multiple dose pharmacokinetic group).||L/h/70 kg||Standard Deviation|Mean
680914|NCT01563185|Secondary|Single Dose Pharmacokinetic Characteristics of DUEXIS in JIA Patients: Area Under the Concentration-time Curve From the Time of Dosing to the Last Measurable Concentration (AUC(0-t))|AUC(0-t) was estimated for ibuprofen and famotidine. The PK parameters for ibuprofen and famotidine represent average AUC values following a single oral dose of DUEXIS. Samples were collected pre-dose and at 0.5, 1, 2, 4, and 8 to 10 hours following study drug administration.|Pre-dose, and 0.5, 1, 2, 4, 8 hours post-dose|The initial 9 patients met the PK objective of the study (4 were in the single dose pharmacokinietic group, however, 1 patient was not evaluable, and all 9 were in the multiple dose pharmacokinetic group).||ug*h/mL||Standard Deviation|Mean
681093|NCT01562314|Primary|Percentage of Participants Achieving Remission, Quantified as a Mayo Score of 2 or Less (With no Sub-score >1).|The Mayo score is an assessment of ulcerative colitis activity, with higher scores indicating more severe disease. The Mayo total score (range 0-12 points) is made up of four sub-scores (stool frequency, rectal bleeding, endoscopy findings and the physicians assessment of illness severity); each carrying equal numerical weight (0-3 points).|Baseline to end of treatment (10 weeks treatment period)|Intention to treat (ITT) analysis set||percentage of participants|||Number
680916|NCT01563185|Secondary|Single Dose Pharmacokinetic Characteristics of DUEXIS in JIA Patients: Time of Maximum Observed Concentration (Tmax)|Tmax was estimated for ibuprofen and famotidine.The PK parameters for ibuprofen and famotidine represent average Tmax values following a single oral dose of DUEXIS. Samples were collected pre-dose and at 0.5, 1, 2, 4, and 8 to 10 hours following study drug administration.|Pre-dose, 0.5, 1, 2, 4, 8 hours post-dose|The initial 9 patients met the PK objective of the study (4 were in the single dose pharmacokinietic group, however, 1 of the patients was not evaluable, and all 9 were in the multiple dose pharmacokinetic group).||hours||Standard Deviation|Mean
680917|NCT01563185|Secondary|American College of Rheumatology (ACR) Pediatric Core Measures: Serum C Reactive Protein (CRP) Concentration|The following ACR pediatric Core Measure of JIA activity and the parent's assessment of discomfort were quantitatively assessed at baseline and each study visit: CRP Concentration. This ACR value represents the average change in Serum C Reactive Protein (CRP) Concentration from the baseline visit to the week 24/ET visit. The normal range referenced was 0 mg/L - 4.99 mg/L.|Baseline to Endpoint (Endpoint is the last post-baseline value obtained, as two subjects did not complete the study up until week 24).|||mg/L||Standard Error|Mean
680918|NCT01563185|Secondary|ACR Pediatric Components by Time Point: Number of Joints With Active Arthritis and the Number of Joints With Limited Range of Motion Number of Joints With Active Arthritis|"The following 2 ACR pediatric Core Measures of JIA activity and the parent's assessment of discomfort were quantitatively assessed at baseline and each study visit: number of joints with active arthritis and the number of joints with limited range of motion. These ACR values represent the average change in number of joints with active arthritis and the number of joints with limited range of motion from the baseline visit to the week 24/ET visit.
The joints that were assessed include the right and left temporomandibular, sternoclavicular, arcomiclavicular, shoulder, elbow, wrist, MCP - 1. MCP - 2, MCP - 3, MCP - 4, MCP - 5, PIP - 1, PIP - 2, PIP - 3, PIP - 4, PIP - 5, DIP - 1, DIP - 2, DIP - 3, DIP - 4, and DIP - 5."|Baseline to Endpoint (Endpoint is the last post-baseline value obtained, as two subjects did not complete the study up until week 24).|||Number of joints||Standard Error|Mean
680919|NCT01563185|Secondary|American College of Rheumatology (ACR) Pediatric Core Measures: CHAQ - Disability Index|The following ACR pediatric Core Measure of JIA activity and the parent's assessment of discomfort were quantitatively assessed at baseline and each study visit: CHAQ - Disability Index. This ACR measurement represents the average change in the Childhood Health Assessment Questionnaire (CHAQ) - Disability Index from the baseline visit to the week 24/ET visit. The CHAQ disability index is measured on a scale of 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, 3 = unable to do).|Baseline to Endpoint (Endpoint is the last post-baseline value obtained, as two subjects did not complete the study up until week 24).|||units on a scale||Standard Error|Mean
680920|NCT01563185|Secondary|American College of Rheumatology (ACR) Pediatric Core Measures: Physician's Global Assessment of Disease Activity and Parent's Assessment of Overall Well-being|The following 2 ACR pediatric Core Measures of JIA activity and the parent's assessment of discomfort were quantitatively assessed at baseline and each study visit: the physician's global assessment of disease activity and the parent's global assessment of overall well-being. These ACR values represent the average change in the physician's global assessment of disease activity and the parent's global assessment of overall well-being from the baseline visit to the week 24/ET visit. The ACR pediatric core measure: Physician's global assessment of disease activity and parent's assessment of overall well being was measured on a scale of 0-100 mm (0 = very good, 100=very poor).|Baseline to Endpoint (Endpoint is the last post-baseline value obtained, as two subjects did not complete the study up until week 24).|||units on a scale||Standard Error|Mean
680921|NCT01563185|Secondary|Childhood Health Questionnaire Parent Form 50 (CHQ-PF50) Scores|"To assess patient quality of life while on study medication, the CHQ was administered to the patients' parent or guardian on Day 0 and at the Week 24/ET visit. The raw scale scores were transformed into scores on a 0 to 100 scale, 100 indicating best health and 0 indicating worst health. The algorithm is:
Transformed Score = ((Actual Raw Score - Lowest Possible Raw Score)/(Possible Raw Score Range)) x100. The actual raw score is the mean of the item responses in a scale (sum of item responses/number of completed items). The possible raw score range is the highest possible raw score minus the lowest possible raw score. The outcome measure data table shows the average change in the CHQ concepts from Baseline to the week 24 visit. The average change in the CHQ concepts is on a -100 to 100 scale, -100 representing a negative change in health and 100 indicating a positive change in health."|Baseline to Endpoint (Endpoint is the last post-baseline value obtained, as two subjects did not complete the study up until week 24).|||units on a scale||Standard Deviation|Mean
680922|NCT01563185|Primary|Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs)|Safety assessments included AE monitoring, concomitant medication review, physical examinations (including vital signs and weight), and clinical laboratory assessments, including pregnancy testing for female patients. The outcome measure data table below describes the TEAEs experienced by patients.|Day 0 through Week 26/ET (adverse event data was collected at every visit, including telephone visits)|||participants|||Number
680923|NCT01563172|Secondary|Enamel Fluoride Uptake (EFU) After Brushing for 2 Minutes With 1.5g of Experimental Dentifrice vs. Brushing for 2 Minutes With 1.5g of Control Dentifrice.|EFU was measured by using micro-drill analysis of the enamel specimens carried out after 14 days of intra-oral exposure for each of the toothpaste treatments. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores.|At Day 14|PP population included all randomized participants who had no major protocol deviations that were felt by the investigator to have affected the assessment of efficacy for all treatments.||μg×F/cm2||Standard Error|Least Squares Mean
680924|NCT01563172|Secondary|Enamel Fluoride Uptake (EFU) After Brushing for 45 Seconds With 0.5g of Experimental Dentifrice vs. Brushing for 45 Seconds With 1.5g of Experimental Dentifrice.|EFU was measured by using micro-drill analysis of the enamel specimens carried out after 14 days of intra-oral exposure for each of the toothpaste treatments. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores.|At Day 14|PP population included all randomized participants who had no major protocol deviations that were felt by the investigator to have affected the assessment of efficacy for all treatments.||μg×F/cm2||Standard Error|Least Squares Mean
683275|NCT01529827|Secondary|Progression Free Survival (PFS) at One Year|Assessed using Kaplan Meier and Proportional Hazards|day of transplant until progression up to 5 years|All treated and eligible patients||percentage of participants||95% Confidence Interval|Number
680925|NCT01563172|Secondary|Enamel Fluoride Uptake (EFU) After Brushing for 2 Minutes With 0.5g of Experimental Dentifrice vs. Brushing for 2 Minutes With 1.5g of Experimental Dentifrice.|EFU was measured by using micro-drill analysis of the enamel specimens carried out after 14 days of intra-oral exposure for each of the toothpaste treatments. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores.|At Day 14|PP population included all randomized participants who had no major protocol deviations that were felt by the investigator to have affected the assessment of efficacy for all treatments.||μg×F/cm2||Standard Error|Least Squares Mean
680926|NCT01563172|Secondary|Enamel Fluoride Uptake (EFU) After Brushing for 2 Minutes vs. Brushing for 45 Seconds With 0.5g of Experimental Dentifrice.|EFU was measured by using micro-drill analysis of the enamel specimens carried out after 14 days of intra-oral exposure for each of the toothpaste treatments. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores.|At Day 14|PP population included all randomized participants who had no major protocol deviations that were felt by the investigator to have affected the assessment of efficacy for all treatments.||μg×F/cm2||Standard Error|Least Squares Mean
680927|NCT01563172|Secondary|Enamel Fluoride Uptake (EFU) After Brushing for 2 Minutes vs. Brushing for 45 Seconds With 1.5g of Experimental Dentifrice.|EFU was measured by using micro-drill analysis of the enamel specimens carried out after 14 days of intra-oral exposure for each of the toothpaste treatments. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores.|At Day 14|PP population included all randomized participants who had no major protocol deviations that were felt by the investigator to have affected the assessment of efficacy for all treatments.||micrograms (μg)×F/centimeters(cm)2||Standard Error|Least Squares Mean
680928|NCT01563172|Secondary|Percent Surface Micro-hardness (% SMH) Recovery, of Brushing for 2 Minutes With 1.5g of Experimental Dentifrice vs. Brushing for 2 Minutes With 1.5g of an Control Dentifrice.|SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH recovery was performed in-vitro and determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents re-hardening of enamel surface. % SMH recovery was calculated from indentation length (μm) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization (D1), indentation length (μm) after intra-oral exposure (R): [D1-R/D1-B] ×100.|At Baseline and at Day 14|PP population included all randomized participants who had no major protocol deviations that were felt by the investigator to have affected the assessment of efficacy for all treatments.||% SMH||Standard Error|Least Squares Mean
680929|NCT01563172|Secondary|Percentage Surface Micro-hardness Recovery (% SMH), of Brushing for 45 Seconds With 0.5g of Experimental Dentifrice vs. Brushing for 45 Seconds With 1.5g of Experimental Dentifrice.|SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH recovery was performed in-vitro and determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents re-hardening of enamel surface. % SMH recovery was calculated from indentation length (μm) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization (D1), indentation length (μm) after intra-oral exposure (R): [D1-R/D1-B] ×100.|At Baseline and at Day 14|PP population included all randomized participants who had no major protocol deviations that were felt by the investigator to have affected the assessment of efficacy for all treatments.||% SMH||Standard Error|Least Squares Mean
680930|NCT01563172|Secondary|Percentage Surface Micro Hardness (% SMH) Recovery, of Brushing for 2 Minutes With 0.5g of Experimental Dentifrice vs. Brushing for 2 Minutes With 1.5g of Experimental Dentifrice.|SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH recovery was performed in-vitro and determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents re-hardening of enamel surface. % SMH recovery was calculated from indentation length (μm) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization (D1), indentation length (μm) after intra-oral exposure (R): [D1-R/D1-B] ×100.|At Baseline and at Day 14|PP population included all randomized participants who had no major protocol deviations that were felt by the investigator to have affected the assessment of efficacy for all treatments.||% SMH||Standard Error|Least Squares Mean
680931|NCT01563172|Secondary|Percentage Surface Micro Hardness (% SMH) Recovery , of Brushing for 2 Minutes vs. Brushing for 45 Seconds With 0.5g of Experimental Dentifrice.|SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH recovery was performed in-vitro and determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents re-hardening of enamel surface. % SMH recovery was calculated from indentation length (μm) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization (D1), indentation length (μm) after intra-oral exposure (R): [D1-R/D1-B] ×100.|At Baseline and at Day 14|PP population included all randomized participants who had no major protocol deviations that were felt by the investigator to have affected the assessment of efficacy for all treatments.||% SMH||Standard Error|Least Squares Mean
680932|NCT01563172|Primary|Percentage Surface Micro Hardness Recovery (% SMH), of Brushing for 2 Minutes Versus (vs.) Brushing for 45 Seconds With 1.5g of Experimental Dentifrice.|SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH recovery was performed in-vitro and determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents re-hardening of enamel surface. % SMH recovery was calculated from indentation length (micrometer [μm]) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization (D1), indentation length (μm) after intra-oral exposure (R): [D1-R/D1-B] ×100.|At Baseline and at Day 14|Per Protocol (PP) population: Included all randomized participants who had no major protocol deviations that were felt by the investigator to have affected the assessment of efficacy for all treatments.||% SMH||Standard Error|Least Squares Mean
680933|NCT01563081|Secondary|Cmax and Cmin of Levocetirizine in Plasma|Cmax is defined as the peak plasma concentration of a drug after administration. Cmin is defined as the lowest (trough) concentration that a drug reaches before the next dose is administered. For both age cohorts, blood samples were collected 1.5-2.5 hours after the last drug administration for assessment of Cmax at either Week 1 or 2/EW. For participants in the >=6 months and <12 months cohort, blood samples were collected 22.5-25.5 hours after the last drug administration for Cmin at a different visit from Cmax sampling. For participants in the >=12 months and <24 months cohort, blood samples were collected 10.5-13.5 hours after the final drug administration for Cmin at a different visit from Cmax sampling. For all participants, if Cmin sampling occurred at Week 1, then Cmax sampling occurred at Week 2/EW, and vice versa.|Weeks 1 and 2/Early Withdrawal|Pharmacokinetic Concentration Population: all participants who underwent blood sampling, who provided data at the time of the last dose and the time of blood sampling, and who provided valid drug concentrations||nanograms per milliliter||Full Range|Median
680934|NCT01563081|Secondary|Number of Participants Categorized With the Indicated Pruritis Severity on the First Day of Treatment and at Weeks 1 and 2/Early Withdrawal|The investigator comprehensively assessed the pariticipant’s severity of pruritus on the first day of treatment (FDOT), at Week 1, and at Week 2 (or at the discontinuation day in the case of early withdrawal [EW] from the clinical trial) by using the following scale: 4, severe; 3, moderate; 2, mild; 1, slight; 0, none.|First day of treatment; Weeks 1 and 2/Early Withdrawal|FAS. Only those participants with pruritis associated with skin diseases at Baseline were assessed for pruritis severity.||participants|||Number
680935|NCT01563081|Secondary|Number of Participants With the Indicated Change From the First Day of Treatment in Nasal Symptoms and Pruritis Associated With Skin Diseases at Weeks 1 and 2/Early Withdrawal, as Assessed by the Investigator or Sub-investigator|The investigator or sub-investigator comprehensively assessed the participants' improvement in nasal symptoms (allergic rhinitis [AR]) and pruritus associated with skin diseases (PAWSD) at Weeks 1 and 2 (or at the discontinuation day in the case of early withdrawal [EW] from the clinical trial) compared to the first day of treatment by using the following scale: 1, markedly improved; 2, moderately improved; 3, slightly improved; 4, no change; 5, worsened.|First day of treatment; Weeks 1 and 2/Early Withdrawal|"FAS. Only those participants with AR and PAWSD at Baseline were assessed for improvement in the conditions at Weeks 1 and 2/Early Withdrawal. The ns in the category titles reflect the number of participants in the Full Analysis Set (FAS) who had AR and PAWSD at Baseline."||participants|||Number
680936|NCT01563081|Secondary|Number of Participants With the Indicated Change From the First Day of Treatment in Allergic Rhinitis and Pruritis Associated With Skin Diseases at Weeks 1 and 2/EW, as Assessed by the Investigator/Sub-investigator Based on Legal Representative Impression|"The investigator or sub-investigator made an overall assessment of nasal symptoms (allergic rhinitis [AR]) and pruritus associated with skin diseases (PAWSD) at Weeks 1 and 2 (or at the discontinuation day in the case of early withdrawal [EW] from the clinical trial) by asking the participants' legal representatives to provide feedback using the following scale: 1, significantly improved; 2, moderately improved; 3, mildly improved; 4, no change; 5, mildly worse; 6, moderately worse; 7, significantly worse. Only those participants with AR and PAWSD at Baseline were assessed for improvement in the conditions at Weeks 1 and 2. The ns in the category titles reflect the number of participants in the Full Analysis Set (FAS) who had AR and PAWSD at Baseline."|First day of treatment; Weeks 1 and 2/Early Withdrawal|Full Analysis Set (FAS): all participants, excluding those with any major good clinical practice deviation, those who did not meet the primary criteria for enrollment, those who received no dose of study medication, and those with no data after supply of the investigational product||participants|||Number
680937|NCT01563081|Primary|Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events (AEs)|A non-serious AE is defined as any untoward medical occurrence in a participant/clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse, or misuse. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is a possible drug-induced liver injury. For a list of all SAEs/non-serious AEs occurring at a frequency of >=5%, please see the SAE/non-serious AE module of this record.|up to Week 2/Early Withdrawal (EW)|Safety Population : all participants who participated in this study and who received at least one dose of medication||participants|||Number
680938|NCT01563055|Secondary|AUC (0-6)/D, AUC(0-24)/D, AUC (0-inf)/D and AUC (0-tau)/D of Phenyl Acetic Acid Mustard|Dose adjusted AUC for the indicated time points were assessed at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||hr*ng/mL/mg||95% Confidence Interval|Geometric Mean
680939|NCT01563055|Secondary|AUC (0-6)/D, AUC(0-24)/D, AUC (0-inf)/D, and AUC (0-tau)/D of Chlorambucil|Dose adjusted AUC for the indicated time points were assessed at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||hr*ng/mL/mg||95% Confidence Interval|Geometric Mean
681032|NCT01562548|Secondary|Mean Change From Baseline of Both AM and PM NRS Muscle Stiffness Assessment Scores|The score was measured as 'assessment at baseline' minus 'assessment after treatment' over 7 day period (mean of all AM and PM changes from baseline). Measurements were based on an 11 categorical Numerical Rating Scale (NRS) with a range from 0 - no stiffness to 10 - unbearable stiffness.|7 Days|Efficacy analysis were conducted on the intention-to-treat (ITT) population, defined as all subjects who receive at least one dose of study medication and who had at least one post-baseline efficacy assessment.||Score on a scale||Standard Deviation|Mean
680940|NCT01563055|Secondary|Cmax/D for Phenyl Acetic Acid Mustard|Cmax/D is defined as the maximum plasma concentration (Cmax) per unit dose. It was assessed at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||ng/mL/mg||95% Confidence Interval|Geometric Mean
680941|NCT01563055|Secondary|Dose Normalized Cmax (Cmax/D) for Chlorambucil|Cmax/D is defined as the maximum plasma concentration (Cmax) per unit dose. It was assessed at Cycle 1-Day 1, Cycle 1-Day 4 and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||ng/mL/mg||95% Confidence Interval|Geometric Mean
680942|NCT01563055|Secondary|AUC (0-t) of Phenyl Acetic Acid Mustard|AUC (0-t) represents the area under the concentration curve of phenyl acetic acid mustard in serum from 0 to time t hours. AUC (0-t) was assessed at 6 hours and 24 hours.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||hr*ng/mL||95% Confidence Interval|Geometric Mean
680943|NCT01563055|Secondary|AUC (0-t) of Chlorambucil|AUC (0-t) represents the area under the concentration curve of chlorambucil in serum from 0 to time t hours. AUC (0-t) was assessed at 6 hours and 24 hours.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||hr*ng/mL||95% Confidence Interval|Geometric Mean
680944|NCT01563055|Secondary|AUC (0-t) of Ofatumumab|AUC (0-t) represents the area under the concentration curve of ofatumumab in plasma from 0 to time t hours. AUC (0-t) was assessed at 168 hours and 672 hours post-dose.|Cycle 1-Day 1 and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||hr*µg/mL||95% Confidence Interval|Geometric Mean
680945|NCT01563055|Secondary|%AUC_extrap of Phenyl Acetic Acid Mustard|%AUC_extrap is defined as the area under the plasma concentration-time curve extrapolated from time t to infinity as a percentage of total AUC. It was assessed at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||percentage of AUC after extrapolation||95% Confidence Interval|Geometric Mean
680946|NCT01563055|Secondary|%AUC_extrap of Chlorambucil|%AUC_extrap is defined as the area under the plasma concentration-time curve extrapolated from time t to infinity as a percentage of total AUC. It was assessed at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||percentage of AUC after extrapolation||95% Confidence Interval|Geometric Mean
680947|NCT01563055|Secondary|%AUC_extrap of Ofatumumab|%AUC_extrap is defined as the area under the plasma concentration-time curve extrapolated from time t to infinity as a percentage of total AUC. Samples were collected at Cycle 1-Day 1 (pre-dose, end of infusion, 10 min, 1 hr, 2 hr, 24 hr, 72 hr, 120 hr).|Cycle 1-Day 1|PK Population||percentage of AUC after extrapolation||95% Confidence Interval|Geometric Mean
680948|NCT01563055|Secondary|Apparent Volume of Distribution During Terminal Phase (Vz/F) of Chlorambucil|Vz/F of chlorambucil is defined as the apparent volume of distribution during terminal phase after non-intravenous (oral) administration of chlorambucil. It was assessed at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||L/m^2||95% Confidence Interval|Geometric Mean
680949|NCT01563055|Secondary|Apparent Total Clearance of the Drug From Plasma (CL/F) for Chlorambucil|CL/F is defined as the apparent total clearance of the drug from plasma after oral administration of chlorambucil. It was assessed at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||L/hr/m^2||95% Confidence Interval|Geometric Mean
680950|NCT01563055|Secondary|Volume of Distribution (Vz) of Ofatumumab|Vz for ofatumumab was calculated as a ratio of the amount of ofatumumab in the body during the terminal phase to the plasma concentration during the terminal phase. Samples were collected at Cycle 1-Day 1 (pre-dose, end of infusion, 10 min, 1hr, 2 hr, 24 hr, 72 hr, 120 hr).|Cycle 1-Day 1|PK Population||mL||95% Confidence Interval|Geometric Mean
680951|NCT01563055|Secondary|Mean Residence Time Inf (MRTinf) of Phenyl Acetic Acid Mustard|MRTinf is the average amount of time that phenyl acetic acid mustard spends in the body. Blood samples were collected at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||hours||95% Confidence Interval|Geometric Mean
680952|NCT01563055|Secondary|Mean Residence Time Inf (MRTinf) of Chlorambucil|MRTinf is the average amount of time that chlorambucil spends in the body. Blood samples were collected at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||hours||95% Confidence Interval|Geometric Mean
680953|NCT01563055|Secondary|Mean Residence Time to Infinity (MRTinf) of Ofatumumab|MRTinf is the average amount of time that ofatumumab spends in the body. Samples were collected at Cycle 1-Day 1 (pre-dose, end of infusion, 10 min, 1hr, 2 hr, 24 hr, 72 hr, 120 hr).|Cycle 1-Day 1|PK Population||hours||95% Confidence Interval|Geometric Mean
680954|NCT01563055|Secondary|Time to Maximum Concentration (Tmax) of Phenyl Acetic Acid Mustard|Tmax is the time required for reaching maximum concentration of drug (Cmax). Blood samples were collected at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||hours||Full Range|Median
680955|NCT01563055|Secondary|Time to Maximum Concentration (Tmax) of Chlorambucil|Tmax is the time required for reaching maximum concentration of drug (Cmax). Blood samples were collected at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||hours||Full Range|Median
680956|NCT01563055|Secondary|Time to Maximum Concentration (Tmax) of Ofatumumab|Tmax is the time required for reaching maximum concentration of drug (Cmax). Samples were collected at Cycle 1-Day 1 (pre-dose, end of infusion, 10 min, 1hr, 2 hr, 24 hr, 72 hr, 120 hr) and Cycle 3-Day 57 (pre-dose, end of infusion, 10 min, 1 hr, 2 hr, 24 hr, 72 hr, 120 hr, 168 hr).|Cycle 1-Day 1 and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||hours||Full Range|Median
680957|NCT01563055|Secondary|Plasma Half-life (t1/2) of Phenyl Acetic Acid Mustard|t1/2 is the time required for the plasma/serum concentration of phenylacetic acid mustard to decrease by half. Blood samples for serum concentration of phenylacetic acid mustard was collected at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population||hours||95% Confidence Interval|Geometric Mean
680958|NCT01563055|Secondary|Plasma Half-life (t1/2) of Chlorambucil|t1/2 is the time required for the serum concentration of chlorambucil to decrease by half. Blood samples for serum concentration of chlorambucil was collected at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||hours||95% Confidence Interval|Geometric Mean
680959|NCT01563055|Secondary|Plasma Half-life (t1/2) of Ofatumumab|t1/2 is the time required for the plasma concentration of ofatumumab to decrease by half. Samples were collected at Cycle 1-Day 1 (pre-dose, end of infusion, 10 min, 1hr, 2 hr, 24 hr, 72 hr, 120 hr) and Cycle 3-Day 57 (pre-dose, end of infusion, 10 min, 1 hr, 2 hr, 24 hr, 72 hr, 120 hr, 168 hr).|Cycle 1-Day 1 and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||hours||95% Confidence Interval|Geometric Mean
680960|NCT01563055|Secondary|Volume of Distribution at Steady State (Vss) of Ofatumumab|Volume of distribution at steady state (Vss) is defined as the distribution of a drug between plasma and the rest of the body at steady state. Samples were collected at Cycle 1-Day1 (pre-dose, end of infusion, 10 min, 1hr, 2 hr, 24 hr, 72 hr, 120 hr).|Cycle 1-Day 1|PK Population||mL||95% Confidence Interval|Geometric Mean
680961|NCT01563055|Secondary|AUC(0-infinity) for Phenyl Acetic Acid Mustard|The total AUC or AUC(0-infinity) is the area under the curve from time 0 extrapolated to infinite time. It was assesed at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||Hr*ng/mL||95% Confidence Interval|Geometric Mean
683312|NCT01529385|Primary|Microcirculation for Dorsum of Foot|microcirculation as measured by skin perfusion pressure|change from baseline after 4 weeks of sock usage|||mmHg||95% Confidence Interval|Mean
680962|NCT01563055|Secondary|AUC(0-infinity) for Chlorambucil|The total AUC or AUC0-infinity is the area under the curve from time 0 extrapolated to infinite time. It was assesed at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||Hr*ng/mL||95% Confidence Interval|Geometric Mean
680963|NCT01563055|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC[0-infinity]) for Ofatumumab|The total AUC or AUC0-infinity is the area under the curve from time 0 extrapolated to infinite time. It was assesed on Cycle 1-Day 1. The samples were collected at Cycle 1-Day1 (pre-dose, end of infusion, 10 min, 1hr, 2 hr, 24 hr, 72 hr, 120 hr).|Cycle 1-Day 1|PK Population||Hr*ug/mL||95% Confidence Interval|Geometric Mean
680964|NCT01563055|Secondary|AUC(0-tau) of Phenyl Acetic Acid Mustard|Area under the concentration time curve over the dosing interval (AUC[0-tau]) is a measure of drug exposure over time. AUC(0-tau) is defined as the area under the drug plasma/serum concentration-time curve from dosing to time tau, where tau is the length of the dosing interval of the drug. It was assesed at 1st (Cycle 1-Day 1), 4th (Cycle 1-Day 4), and 15th (Cycle 3-Day 57) chlorambucil administration. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||Hr*ng/mL||95% Confidence Interval|Geometric Mean
680965|NCT01563055|Secondary|AUC(0-tau) of Chlorambucil|Area under the concentration time curve over the dosing interval (AUC[0-tau]) is a measure of drug exposure over time. AUC(0-tau) is defined as the area under the drug plasma/serum concentration-time curve from dosing to time tau, where tau is the length of the dosing interval of the drug. It was assesed at 1st (Cycle 1-Day 1), 4th (Cycle 1-Day 4), and 15th (Cycle 3-Day 57) chlorambucil administration. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||Hr*ng/mL||95% Confidence Interval|Geometric Mean
680966|NCT01563055|Secondary|Area Under the Drug Plasma Concentration-time Curve From Dosing to Time Tau (AUC[0-tau]) of Ofatumumab|Area under the concentration time curve over the dosing interval (AUC[0-tau]) is a measure of drug exposure over time. AUC(0-tau) is defined as the area under the drug plasma/serum concentration-time curve from dosing to time tau, where tau is the length of the dosing interval of the drug. For ofatumumab it was assesed at Cycle 1-Day 1 and Cycle 3-Day 57. Samples were collected at Cycle 1-Day 1 (pre-dose, end of infusion, 10 min, 1 hr, 2 hr, 24 hr, 72 hr, 120 hr) and Cycle 3-Day 57 (pre-dose, end of infusion, 10 min, 1 hr, 2 hr, 24 hr, 72 hr, 120 hr, 168 hr).|Cycle 1-Day 1 and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||Hours*nanogram/milliliter (hr*ng/mL||95% Confidence Interval|Geometric Mean
680967|NCT01563055|Secondary|Total Plasma Clearance (CL) of Ofatumumab|Plasma clearance is defined as the plasma volume which is totally cleared of drug per unit of time. Blood samples were collected at Cycle 1-Day1 (pre-dose, end of infusion, 10 min, 1hr, 2 hr, 24 hr, 72 hr, 120 hr).|Cycle 1-Day 1|PK Population||Milliliters/hour (mL/hr)||95% Confidence Interval|Geometric Mean
680968|NCT01563055|Secondary|Cmin of Phenyl Acetic Acid Mustard|Cmin of chlorambucil metabolite phenyl acetic acid mustard was assesed at Cycle 1-Day 4 and Cycle 3-Day 57. Blood samples were collected at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 4 and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||ng/mL||95% Confidence Interval|Geometric Mean
680969|NCT01563055|Secondary|Cmin of Chlorambucil|Cmin of chlorambucil was assesed at Cycle 1-Day 4 and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 4 and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||ng/mL||95% Confidence Interval|Mean
680970|NCT01563055|Secondary|Minimum Plasma Concentration (Cmin) of Ofatumumab|Minimum plasma drug concentration of ofatumumab was determined at Cycle 1-Day 8, Cycle 2-Day 29, Cycle 3-Day 57, Cycle 4-Day 85, Cycle 5-Day 113, and Cycle 6-Day 141. Samples were collected at Cycle 1-Day 1 (pre-dose, end of infusion, 10 min, 1hr, 2 hr, 24 hr, 72 hr, 120 hr), Cycle 2-Day 29 (pre-dose), Cycle 3-Day 57 (pre-dose, end of infusion, 10 min, 1 hr, 2 hr, 24 hr, 72 hr, 120 hr, 168 hr), Cycle 4-Day 85 (pre-dose, 30 min post end of infusion), Cycle 5-Day 113 (pre-dose and end of infusion) and Cycle 6-Day 141 (pre-dose and end of infusion).|Cycle 1-Day 8, Cycle 2-Day 29, Cycle 3-Day 57, Cycle 4-Day 85, Cycle 5-Day 113, and Cycle 6-Day 141|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||Micrograms/milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
681057|NCT01562327|Secondary|Percentage of Participants With Systemic Manifestations of RA at Baseline|Systemic manifestations of RA included anemia, fatigue, conventional risk factors for cardiovascular disease, C-Reactive Protein (CRP) above upper limit of normal, rheumatoid nodules, rheumatoid vasculitis and interstitial lung disease. Participants were included if they experienced at least one of the conditions.|Baseline|FAS was defined as all participants who received at least one dose of Tocilizumab.||percentage of participants|||Number
680971|NCT01563055|Secondary|Cmax of Serum Phenyl Acetic Acid Mustard|Cmax of chlorambucil metabolite phenyl acetic acid mustard was assesed at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||ng/mL||95% Confidence Interval|Geometric Mean
680972|NCT01563055|Secondary|Cmax of Serum Chlorambucil|Cmax of serum chlorambucil was assesed at Cycle 1-Day 1, Cycle 1-Day 4 and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||ng/mL||95% Confidence Interval|Geometric Mean
680973|NCT01563055|Secondary|Maximum (Peak) Plasma Concentration (Cmax) of Ofatumumab|Maximum (peak) plasma drug concentration of ofatumumab was determined at Cycle 1-Day 1 and Cycle 3-Day 57. Samples were collected at Cycle 1-Day 1 (pre-dose, end of infusion, 10 min, 1hr, 2 hr, 24 hr, 72 hr, 120 hr), and Cycle 3-Day 57 (pre-dose, end of infusion, 10 min, 1 hr, 2 hr, 24 hr, 72 hr, 120 hr, 168 hr).|Cycle 1-Day 1 and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||Micrograms/milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
680974|NCT01563055|Secondary|Complement (CH50) at Cycle 1-Day 1 and Cycle 4-Day 85|The CH50 is the serum complement to lyse 50% of sensitized red blood cells; it is a marker of complement activation. A high CH50 level suggests evidence for complement activation, whereas a low CH50 level suggests lack of complement activation. Peripheral blood samples were collected for analysis at Cycle 1-Day 1 and Cycle 4-Day 85.|Cycle 1-Day 1 and Cycle 4-Day 85|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects pPopulation.||Kilo units per liter (KU/L)||Standard Deviation|Mean
680975|NCT01563055|Secondary|Beta-2 Microglobulin at Cycle 1-Day 1|Beta-2-microglobulin is a protein present on the surface of most cells. Higher levels indicate a poor prognosis of CLL. Beta-2 microglobulin was measured at Cycle 1-Day 1.|Cycle 1-Day 1|All Subjects Population||Nanomoles per liter (NMOL/L)||Standard Deviation|Mean
680976|NCT01563055|Secondary|Change From Baseline in CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points|CD5+CD19+ cells were counted in peripheral blood by flow cytometry. Baseline CD5+CD19+ and CD5-CD19+ cell count value is the last pre-dose assessment values performed on Cycle 1-Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. B-cell monitoring (CD5+CD19+ and CD5-CD19+) was performed at Cycle 1 (Day 1, Day 15) and Cycle 2 (Day 29, Day 43), on Day 1 of Cycle 3, 4, 5, 6, 9 and 12 (Day 57, Day 85, Day 113, Day 141, Day 225, Day 309), 28 days after the first day of the last treatment cycle (FU 1-PDFU 1) for all participants depending on the number of cycles administered, and 84 and 168 days after the day of FU 1-PDFU 1 for participants in CR, PR, and SD.|Baseline, C1-D15, C2-D29, C2-D43, C3-D57, C4-D85, C5-D113, C6-D141, C7-D169, C8-D197, C9-D225, FU 1-PDFU 1 (28 days post Day 1 of Last Cycle), FU 85-PDFU 85 (84 days after FU-1), and FU 169-PDFU 169 (168 days after FU-1)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects population.||Cells per microliter||Standard Deviation|Mean
680977|NCT01563055|Secondary|Number of Participants Who Were Positive or Negative for Minimal Residual Disease (MRD), as Assessed by IRC With CT|MRD refers to small number of leukemic cells that remain in the participant's body during treatment or after treatment in participants who achieved a confirmed complete remission. MRD assessment in bone marrow aspiration sample was perfrmed by flow cytometry (cluster of differentiation [CD]5, CD19, CD20, CD23). The absence of MRD was defined as less than one CLL cell per 10,000 leukocytes. The number of participants who were positive and negative for MRD are presented.|FU 85-PDFU 85 (84 days after FU-1)|All Subjects Population. Only those participants who were positive and negative for MRD were analyzed.||Participants|||Number
680978|NCT01563055|Secondary|Mean Change From Baseline in the Immunoglobulins (Ig) Antibodies IgA, IgG, and IgM at the Indicated Time Points|Immunoglobulins, or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Low levels indicate immuno-suppression. IgA, IgG, and IgM were measured in the blood samples of the participants. Baseline IgA, IgG, and IgM values are the last pre-dose assessment values performed on Cycle 1-Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Immunoglobulins were measured at Cycle 1-Day 1, FU 1-PDFU 1, and FU 169-PDFU 169 for participants in CR, PR, and stable disease (SD).|Baseline (Cycle 1-Day 1), FU 1-PDFU 1 (28 days post Day 1 of Last Cycle), and FU 169-PDFU 169 (168 days after FU-1)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects population.||Grams per liter||Standard Deviation|Mean
680979|NCT01563055|Secondary|Number of Participants With the Indicated Results for Human Anti-human Antibody (HAHA) at the Indicated Time Points|HAHA are indicators of immunogenicity induced by ofatumumab. Blood samples were taken from participants at Screening, Cycle 4-Day 85, FU 1-PDFU 1, and FU 169-PDFU 169. The presence of HAHA in human serum was determined using a validated electrochemiluminescent assay in a multi-tier assay format. The results are presented as participants with HAHA results as positive, negative or confirmation required.|Screening, Cycle 4-Day 85, FU 1-PDFU 1 (28 days post Day 1 of Last Cycle), and FU 169-PDFU 169 (168 days after FU-1)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Participants|||Number
680980|NCT01563055|Secondary|Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events|"Adverse events were graded according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) grade, version 4.03 (1=mild; 2=moderate; 3=severe; 4=life-threatening/disabling; 5=death). AEs not in the list of CTCAE were graded at discretion of the investigator. Myelosuppression is defined as the decrease in the ability of the bone marrow to produce blood cells. Participants with Grade (G)3 or G4 adverse event of infection and myelosuppression (anemia, neutropenia, and thrombocytopenia) are presented. Also presented are number of participants with autoimmune hemolytic anemia (AIHA). AIHA is a disease where the body's immune system fails to recognize red blood cells as self and begins destroying these red blood cells."|From start of treatment until follow-up for survival (up to Week 62.3)|All Subjects Population||Participants|||Number
680981|NCT01563055|Secondary|Number of Participants With AEs of Maximum Severity|Adverse events were graded according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) grade, version 4.03 (1=mild; 2=moderate; 3=severe; 4=life-threatening/disabling; 5=death). AEs not in the list of CTCAE were graded at discretion of the investigator.|From start of treatment until follow-up for survival (up to Week 62.3)|All Subjects Population||Participants|||Number
680982|NCT01563055|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed.|From start of treatment until follow-up for survival (up to Week 62.3)|All Subjects Population||Participants|||Number
680983|NCT01563055|Secondary|Number of Participants With Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)|ECOG PS is a scale to assess disease progression, extent to which disease affects the daily living abilities and determines appropriate treatment and prognosis. It is scored on a scale of 0 to 5 as, 0 (fully active), 1 (restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature), 2 (ambulatory and capable of all self cares but unable to carry out any work activities, up and about > 50% of waking hours), 3 (capable of only limited self cares, confined to bed or chair > 50% of waking hours), 4 (completely disabled, cannot carry on any self cares, totally confined to bed or chair), 5 (death). Improvement is defined as decrease from Baseline by at least one step on the ECOG performance status scale (yes/no). Baseline was the last pre-dose assessment performed on Cycle 1-Day 1(C1-D1). When C1-D1 was missing, the last assessment performed prior to pre-dose C1-D1 was used. It was performed on Day 1 of each cycle and follow-up (FU).|Baseline, C2-D29, C3-D57, C4-D85, C5-D113, C6-D141, C7-D169, C8-D197, C9 -D225, FU 1-PDFU 1 (28 days post Day 1 of Last Cycle), FU 85-PDFU 85 (84 days after FU-1), and FU 169-PDFU 169 (168 days after FU-1)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects population.||Participants|||Number
680984|NCT01563055|Secondary|Number of Participants With no B-symptoms (Constitutional Symptoms) and With at Least One B-symptom (Constitutional Symptoms) at the Indicated Time Points|The number of participants with no B-symptoms (no night sweat [without signs of infection], no unexplained, unintentional weight loss >= 10% within the previous 6 months, no recurrent, unexplained fever of greater than 38 degrees celcius for 2 weeks and no extreme fatigue) and the number of participants with at least one of the B-symptoms are summarized by assessment time. The presence of the B-symptoms was assessed at Baseline, Day 1 of each treatment cycle and follow-up (FU). Baseline was the last pre-dose assessment performed at Cycle (C) 1-Day (D) 1.|Baseline, C2-D29, C3-D57, C4-D85, C5-D113, C6-D141, C7-D169, C8-D197, C9 -D225, FU 1-PDFU 1 (28 days post Day 1 of Last Cycle), FU 85-PDFU 85 (84 days after FU-1), and FU 169-PDFU 169 (168 days after FU-1)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Participants|||Number
680985|NCT01563055|Secondary|Time to Next Chronic Lymphocytic Leukemia (CLL) Therapy|Time to next CLL therapy is defined as the time from start of treatment until the first administration of the next CLL treatment other than chlorambucil administrations scheduled in this study. Time to next CLL therapy was restricted to the subgroup of the population who receive a next CLL therapy after experiencing disease progression.|From start of treatment until the first administration of the next CLL therapy (up to Week 62.3)|All Subjects Population. Only those participants who received next CLL therapy were evaluated.||Weeks||95% Confidence Interval|Median
680986|NCT01563055|Secondary|Duration of Response, as Assessed by the IRC|Duration of response is defined as the time from the first documented evidence of CR, CRi, nPR or PR until the first documented sign of PD or death in participants with CR, CRi, nPR or PR. For participants who did not progress or die, duration of response was censored on the date of last assessment.|From initial response (CR/CRi/nPR/PR) until disease progression or death (up to Week 62.3)|All Subjects Population. Only those participants classified as responders (CR, CRi, PR, nPR) were evaluated.||Weeks||95% Confidence Interval|Median
680987|NCT01563055|Secondary|Time to Response, as Assessed by the IRC|Time to response is defined as the time from start of treatment until the first response (CR/CRi/nPR/PR). Response was determined according to the IWCLL updated NCI-WG guidelines, 2008. This analysis only included participants who had a response while in the study, there was no censoring.|From start of treatment until the first response (CR/CRi/nPR/PR) (up to Week 62.3)|All Subjects Population. Only those participants classified as responders (CR, CRi, PR, nPR) were evaluated.||Weeks||95% Confidence Interval|Median
680988|NCT01563055|Secondary|Overall Survival|Overall survival is defined as time from start of treatment until death due to any cause. For participants who did not die, time to death was censored at the time of the last date of contact.|From start of treatment until death (up to Week 62.3|All Subjects Population||Weeks||95% Confidence Interval|Median
683313|NCT01529385|Primary|Microcirculation for Lateral Calf|microcirculation as measured by skin perfusion pressure|change from baseline after 4 weeks of sock usage|||mmHg||95% Confidence Interval|Mean
680989|NCT01563055|Secondary|Progression-free Survival (PFS), as Assessed by the IRC and the Investigator|Progression free survival is defined as the time from start of treatment until disease progression (PD) or death due to any cause. PD was determined by the IRC or investigator according to the definitions of response in the IWCLL updated NCI-WG guidelines, 2008. According to the guidelines, PD is characterized by at least one of the following: lymphadenopathy (appearance of any new lesion such as enlarged lymph nodes (>1.5 centimeter [cm]), spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site); an increase by 50% or more in the previously noted enlargement of the liver or spleen; an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 per microliter B-lymphocytes; transformation to a more aggressive histology; or occurrence of cytopenia attributable to chronic lymphocytic leukemia. PFS was censored at the last visit with adequate assessment for participants who were alive and had not progressed.|From start of treatment until disease progression or death (up to Week 62.3)|All Subjects Population. Only participants who progressed or died were analyzed.||Weeks||95% Confidence Interval|Median
680990|NCT01563055|Secondary|Number of Participants With CR, as Assessed by the IRC, IRC With CT, and the Investigator|Response was determined according to the IWCLL updated NCI-WG guidelines, 2008. According to the guidelines, CR (all the criteria at least 2 months after last treatment): peripheral blood lymphocytes below < 4,000/μL, no Ly > 1.5 cm/ hepatomegaly/ splenomegaly/ constitutional symptoms; Neu >1500 /µL, PL >100,000/µL, Hb >11 g/dL, BM sample must be normocellular for age, <30% lymphocytes, no LN. PR: >=50% decrease in peripheral blood lymphocytes, Ly, size of liver and spleen; and blood count showing at least one of the following results: Neu>1500/μL, PL >100,000/µL or 50% improvement over BL, Hb >11 g/dL or 50% improvement over BL. No increase in LN and no new LN.|From start of treatment until disease progression or death (up to Week 62.3)|All Subjects Population||Participants|||Number
680991|NCT01563055|Primary|Number of Participants With Overall Response, as Assessed by the Independent Review Committee (IRC) With CT, IRC and Investigator|Response evaluated as per International Workshop for Chronic Lymphocytic Leukemia (IWCLL) National Cancer Institute-sponsored Working Group (NCI-WG) Guidelines, 2008. Overall response rate (ORR) is defined as percentage of par. achieving complete remission (CR), nodular partial remission (nPR), CR-incomplete (CRi) or PR. CR (>=2 months after last treatment): lymphocytes (LC) <4000 per microliter (μL), no lymphadenopathy (Ly)>1.5 cm/hepatomegaly/splenomegaly/constitutional symptoms; neutrophils (N)>1500/µL, platelets (PL)>100,000/µL, hemoglobin (Hb)>11 grams/deciliter (g/dL), bone marrow (BM) sample must be normocellular for age,<30% LC, no lymphoid nodule (LN). PR:>=50% decrease in LC, Ly, size of liver and spleen; and at least one of these: N>1500/μL, PL>100,000/µL or 50% improvement over Baseline (BL), Hb>11 g/dL or 50% improvement over BL. nPR: persistent nodules BM. CRi: CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to CLL but related to drug toxicity.|From start of treatment until disease progression or death (up to Week 62.3)|All Subjects Population||Participants|||Number
680992|NCT01563055|Primary|Number of Participants Who Developed Toxicity Requiring Discontinuation From Study Treatment During Cycle 1|Tolerability of ofatumumab in combination with chlorambucil was evaluated based on the number of participants who developed toxicity requiring discontinuation from study treatment during Cycle 1. The treatment was considered tolerable when 0 of 3 participants, or <=2 of 6 participants developed toxicity which required discontinuation of study treatment during Cycle 1. The toxicity requiring discontinuation was determined based on the pre-defined withdrawal criteria.|From start of treatment through Cycle 1 (Week 4)|All Subjects Population: all participants who received at least one dose of investigational product.||Participants|||Number
680993|NCT01563029|Secondary|Number of Withdrawals Due to Lack of Efficacy Throughout the 12-week Treatment Period|The number of participants whose primary reason for withdrawal from the study was due to lack of efficacy is presented together with p-values for the treatment comparisons.|Up to Week 12|ITT Population||Participants|||Number
680994|NCT01563029|Secondary|Change From Baseline in the Percentage of Symptom-free 24-hour Periods During the 12-week Treatment Period|Asthma symptoms were recorded in a daily eDairy by the participants every day in the morning and evening before taking any rescue or study medication and before the PEF measurement. A 24-hour (hr) period in which a participant’s responses to both the morning and evening assessments indicated no symptoms was considered to be symptom free. The Baseline symptom-free value is defined as the percentage of symptom free 24-hr periods in the last 7 days of the run-in period. Change from Baseline was calculated as the averaged value during the 12-week Treatment Period minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, actual pre-screening ICS use, age, and treatment group.|Baseline; Week 1 up to Week 12|ITT Population. Only participants available at the specified time points were analyzed.||Percentage of symptom-free 24-hr periods||Standard Error|Least Squares Mean
680995|NCT01563029|Secondary|Change From Baseline in AM PEF Over the Last 7 Days of the Treatment Period (Week 12)|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline in AM PEF was calculated as the value over the last 7 days of the Treatment Period minus the Baseline value. The Baseline PEF value is defined as the average of the last 7 days of the Run-in Period. Statistical analysis was performed using ANCOVA model with covariates of Baseline, pre-screening ICS use, region, sex, age, and treatment. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurements.|Baseline; Week 12|ITT Population. Only participants available at the specified time points were analyzed.||L/min||Standard Error|Least Squares Mean
680996|NCT01563029|Secondary|Change From Baseline in PM PEF Over the Last 7 Days of the Treatment Period (Week 12)|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline in PM PEF was calculated as the value over the last 7 days of the Treatment Period minus the Baseline value. The Baseline PEF value is defined as the average of the last 7 days of the Run-in Period. Statistical analysis was performed using ANCOVA model with covariates of Baseline, actual pre-screening ICS use, region, sex, age, and treatment. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurements.|Baseline; Week 12|ITT Population. Only participants available at the specified time points were analyzed.||L/min||Standard Error|Least Squares Mean
680997|NCT01563029|Secondary|Change From Baseline in Daily Evening (PM) PEF Averaged Over the 12-week Treatment Period|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline was calculated as the value of the averaged daily PM PEF over the 12-week Treatment Period (at Week 12) minus the Baseline value. The Baseline PEF value is defined as the average of the last 7 days of the Run-in Period. Statistical analysis was performed using ANCOVA model with covariates of Baseline, actual pre-screening ICS use, region, sex, age, and treatment. Particpants analyzed included those who have PEF data for at least 2 non-missing days in the Baseline week prior to randomisation and at least 2 non-missing days after randomisation.|Baseline; Week 1 up to Week 12|ITT Population. Only participants available at the specified time points were analyzed.||liters per minute (L/min)||Standard Error|Least Squares Mean
680998|NCT01563029|Secondary|Change From Baseline in the Percentage of Rescue-free 24-hour Periods During the 12-week Treatment Period|The number of inhalations of rescue albuterol/salbutamol aerosol (medication used to relieve symptoms immediately) used during the day and night) was recorded by the participants in a daily diary. A 24-hour (hr) period in which a participant’s responses to both the morning and evening assessments indicated no use of rescue medication was considered as rescue free. The Baseline rescue-free value was defined as the percentage of rescue-free 24-hr periods from the last 7 days of the Run-in Period. Change from Baseline was calculated as the average value during the 12-week Treatment Period minus the value at Baseline. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, actual pre-screening ICS use, age, and treatment.|Baseline; Week 1 up to Week 12|ITT Population. Only participants available at the specified time points were analyzed.||Percentage of rescue-free 24-hr periods||Standard Error|Least Squares Mean
680999|NCT01563029|Secondary|Change From Baseline in Evening Clinic Visit Trough (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 12-week Treatment Period in Children Who Could Perform the Maneuver|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is defined as a pre-dose FEV1 measurement taken at a clinic visit while still on treatment. Change from Baseline was calculated as the Week 12 trough FEV1 value minus the Baseline value. The Baseline FEV1 value is defined as the value at Visit 3 (randomization). The analysis was performed using an ANCOVA model with covariates of Baseline trough FEV1, region, actual pre-screening ICS use, sex, age, and treatment. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement at scheduled clinic visits was used to impute the missing measurements. Only those participants available at the specified time points were analyzed.|Baseline, Week 12|ITT Population. Only participants available at the specified time points were analyzed.||Liters||Standard Error|Least Squares Mean
681000|NCT01563029|Primary|Change From Baseline in Daily Pre-dose Morning (AM) Peak Expiratory Flow (PEF) From Participant Electronic Daily Diary Averaged Over the 12-week Treatment Period|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. The best of three measurements was recorded. Change from Baseline was calculated as the value of the averaged daily AM PEF over the 12-week Treatment Period minus the Baseline value. The Baseline PEF value is defined as the average of the last 7 days of the Run-in Period. Statistical analysis was performed using an analysis of covariance (ANCOVA) model with covariates of Baseline AM PEF, actual pre-screening inhaled corticosteroid (ICS) use, region, sex, age, and treatment. Particpants analyzed included those who have PEF data for at least 2 non-missing days in the Baseline week prior to randomisation and at least 2 non-missing days after randomisation.|Baseline; Week 1 up to Week 12|ITT Population: participants randomized to treatment who received at least 1 dose of study medication. Only participants available at the specified time points were analyzed.||Liters per minute (L/min)||Standard Deviation|Least Squares Mean
681001|NCT01563003|Secondary|Clinical Global Impression - Severity Scale|Scale range - 0 (minimum) to 6 (maximum). Higher scores represent worse anxiety symptom severity.|After an average of 16 weeks (Post-treatment)|||units on a scale||Standard Deviation|Mean
681002|NCT01563003|Secondary|Anxiety Disorders Interview Schedule Clinical Severity Rating|Scale range - 0 (minimum) to 8 (maximum). Higher scores represent worse anxiety symptom severity.|After an average of 16 weeks (Post-treatment)|||units on a scale||Standard Deviation|Mean
681003|NCT01563003|Primary|Pediatric Anxiety Rating Scale|Scale range - 0 (minimum) to 25 (maximum). Higher scores represent worse anxiety symptom severity.|After an average of 16 weeks (Post-treatment)|||units on a scale||Standard Deviation|Mean
681004|NCT01562886|Secondary|Number of Subjects With HIV Viral Load Above 50 Copies Per mL|Plasma viral load will be measured at all study visits to assess if viral load is above the lower limit of detection (50 copies mL)|Day 3,14, 28, 60, 80-100|||participants|||Number
681005|NCT01562886|Primary|CSF:Plasma Ratio of Rilpivirine Levels|The levels of rilpivirine will be measured in the cerebral spinal fluid and plasma after 60 days of exposure|Day 60|||ratio expressed as a percentage||95% Confidence Interval|Geometric Mean
681006|NCT01562873|Secondary|Progression-Free Survival|Progression-free survival based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) or death. Per RECIST 1.1 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or equivocal progression of non-target lesions.|Disease was evaluated radiologically every 8 weeks on treatment through 12 cycles and in long-term follow-up every 4 months for up to 2 years. Median follow-up in this study cohort was 4.5 months (range 0.6-21.9).|The analysis dataset is comprised all enrolled patients.||months||95% Confidence Interval|Median
681007|NCT01562873|Secondary|Overall Survival|Overall survival is defined as the time from study entry to death or date last known alive and estimated using Kaplan-Meier (KM) methods.|In long-term follow-up, patients were followed for survival every 4 months for up to 2 years. Median follow-up in this study cohort was 4.5 months (range 0.6-21.9).|The analysis dataset is comprised all enrolled patients.||months||95% Confidence Interval|Median
681008|NCT01562873|Secondary|Clinical Benefit Rate|Clinical benefit rate (CBR) was defined as achieving complete response (CR), partial response (PR), or stable disease (SD) for 24 weeks or longer based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PD is at least a 20% increase in sum LD of target lesions (smallest sum LD reference), new lesions, and/or unequivocal progression of existing non-target lesions. Stable disease (SD) is defined as any condition not meeting the above criteria. SD needed to be a minimum 24 weeks in duration.|Disease was evaluated radiologically at baseline and every 8 weeks on treatment; Treatment continued until disease progression or unacceptable toxicity up to 12 cycles. Treatment duration was a median of 2 cycles range (1-5).|The analysis dataset is comprised all enrolled patients.||proportion of patients||90% Confidence Interval|Number
681009|NCT01562873|Primary|Objective Response Rate|The objective response rate (ORR) was defined as achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.|Disease was evaluated radiologically at baseline and every 8 weeks on treatment; Treatment continued until disease progression or unacceptable toxicity up to 12 cycles. Treatment duration was a median of 2 cycles range (1-5).|The analysis dataset is comprised all enrolled patients.||proportion of patients||90% Confidence Interval|Number
681010|NCT01562756|Primary|Feasibility of Conducting a Full-scale Randomized Control Trial to Evaluate Patient Response to Spinal Manipulation: Study Duration.|Feasibility was measured by the study duration from study launch to collection of final study outcomes. This pilot study allowed for testing of equipment, finalizing the data collection protocol, and training study personnel before conducting the full-scale trial.|Approximately 4-6 weeks including initial eligibility screening, baseline visits, and 2 weeks of treatment visits|||months|months||Number
681011|NCT01562756|Primary|Feasibility of Conducting a Full-scale Randomized Control Trial to Evaluate Patient Response to Spinal Manipulation: Number of Participants Who Were Recruited, Consented, Enrolled, and Completed the Study|Feasibility was measured by the numbers of participants: recruited, consented, enrolled, and retained. This pilot study allowed for testing of equipment, finalizing the data collection protocol, and training study personnel before conducting the full-scale trial.|Approximately 4-6 weeks including initial eligibility screening, baseline visits, and 2 weeks of treatment visits|||participants|||Number
681012|NCT01562743|Secondary|Change of Short-Form 36-Item Health Survey (SF-36) From Baseline to Each Visit|SF-36 is a scale for assessing health status in clinical practice and research. The scores of 36 questions are summarized into 7 sub-scales. In each sub-scale which range is 0-100, a higher score indicates a better health status. Thus a increase in the scores means improvement.|Baseline, Up to 53 weeks|FAS, LOCF||Scores on a scale||Standard Deviation|Mean
681013|NCT01562743|Primary|Change of the Pittsburgh Sleep Quality Index (PSQI) From Baseline to Each Visit|PSQI is a scale for assessing severity of sleep disorders. The score ranges from 0 to 21. 0 indicates “no difficulty” and 21 indicates “severe difficulty”. A decrease in the scores means improvement.|Baseline, Up to 53 weeks|FAS, LOCF||Scores on a scale||Standard Deviation|Mean
681014|NCT01562743|Secondary|Change of Augmentation Severity Rating Scale (ASRS) Sum Score From Baseline to Each Visit|"ASRS is a scale for assessing severity of augmentation. ASRS consists of 3 items (one item containing 4 sub-items). The sum of the score of each question serves as the scale score (each question score: 0-3, sum score 0-24).
A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, Up to 52 weeks|FAS, LOCF||Scores on a scale||Standard Deviation|Mean
681015|NCT01562743|Secondary|Efficacy Rate in IRLS Sum Score|Efficacy rate (percentage of subjects with 50% decrease) (LOCF) in IRLS sum score.|Baseline, Up to 53 weeks|FAS, LOCF||Percentage of participants||95% Confidence Interval|Number
681016|NCT01562743|Secondary|Change of IRLS Sum Score From the Baseline to Each Visit|"IRLS is a scale for assessing severity of restless legs syndrome symptoms. IRLS consists of ten questions. Each question is scored from 4 for the first (top) answer (usually ‘very severe’) to 0 for the last answer (usually none).
The sum of the score of each question serves as the scale score. The scale scoring criteria are: Mild (score 1-10); Moderate (score 11-20); Severe (score 21-30); Very severe (score 31-40). A decrease in the scores means improvement."|Baseline, Up to 53 weeks|Full analysis set (FAS), last observation carried forward (LOCF)||Scores on a scale||Standard Deviation|Mean
681017|NCT01562743|Primary|Augmentation|"Augmentation is the main complication during long-term dopaminergic treatment of restless legs syndrome (RLS) and reflects an overall increase in RLS severity.
Augmentation is clinically significant when at least one of the following occurs:
Change in daily activities and/or behavior (e.g., the patient stops riding in cars in the afternoon) due to augmentation;
Negative impact on the patient’s quality of life (sleep, mood, etc.) due to augmentation;
Need to change the treatment dose or the patienｔ needs to take the dose earlier in the day (e.g., dividing the dose);
Adjustments in concomitant medication are made to compensate for augmented RLS symptoms (e.g., an increased intake of analgesics or hypnotics to cover an increase in symptom intensity);
Any other aspect as judged by the evaluator (should be specified)."|Up to 53 weeks|SS||participants|||Number
681018|NCT01562743|Primary|The Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters|"The safety of the long-term SPM 962 treatment was examined based on the incidence and severity of adverse events, vital signs, and laboratory parameters.
AEs of special interest (1-3) are defined as below:
sudden onset of sleep
obsessive-compulsive disorder or impulse-control disorder
hallucination, delusion"|Up to 54 weeks|Safety set (SS)||participants|||Number
681019|NCT01562678|Primary|Change Between Highly Desirable vs. Less Desirable Food Cues in the Effect Size of Cortical Activation During Food Visualization|Effect size (region of interest z-scores, derived from z-maps of the brain) shown below is the difference in parietal cortex activation to highly desirable (high fat or high calorie, e.g. cakes, pies, fries) versus less desirable (low fat or low calorie, e.g. vegetables, fruits) food cues for each treatment condition (liraglutide or placebo) at the end of the treatment period.|18 days of Liraglutide or placebo treatment|Participants with incomplete MRI scans were excluded from the analysis.||z-scores of activation in cortex||Standard Error|Mean
681020|NCT01562613|Secondary|Change in Framingham Stroke Risk Profile Scores of the Participating Patients|"The Framingham Stroke Risk Profile assesses the Probability of Stroke Within 10 Years separately for a) Women Aged 55-84 Years and Free of Previous Stroke AND b) for Men Aged 55-85 Years and Free of Previous Stroke.
First the Framingham Stroke Risk Profile Score is calculated as the sum of points obtained from each of the following factors: age, treated or untreated SBP, presence of diabetes, cigarette smoking, cardiovascular disease, atrial fibrillation, hypertension, and left ventricular hypertrophy according to the gender-specific tables provided by D’Agostino et al (Stroke 1994: 40-43). Subsequently the total score obtained yields the 10-year probability of stroke from gender-specific tables provided in D’Agostino et al.
The score can range from 0-38 (according to the scales of D’ Agostino et al) with higher scores yielding increased 10-year probability of stroke."|Baseline up to 6 months|"Excluded from Framingham calculation were patients with either
a history of cerebrovascular accident
any of the parameters missing for the calculation of the Framingham
age <54 years or > 84 years for females & <54 or > 85 years for males"||score on a scale||Full Range|Median
681021|NCT01562613|Primary|The Absolute Change in Systolic Blood Pressure From Baseline|The absolute change in systolic Blood Pressure from baseline|Baseline up to 6 months|||mmHg||Standard Deviation|Mean
681022|NCT01562613|Primary|The Percentage of Hypertensive Patients Who Achieve Regulated BP Levels According to the ESC/ESH Guidelines, After They Have Been Treated With Eprosartan for 6 Months Under Standard Daily Medical Practice Conditions.|"The percentage of hypertensive patients who achieve regulated BP levels according to the ESC/ESH (European Society of Cardiology/European Society of Hypertension) Guidelines, after they have been treated with eprosartan for 6 months under standard daily medical practice conditions.
Rate of responders (%) who reach the ESH/ESC Guidelines BP levels of <140 mmHg/90 mmHg [systolic BP (SBP)/diastolic BP (DBP)] for the general population of hypertensive patients OR of <130 mmHg/80 mmHg in case of diabetics and high or very high risk patients such as those with associated clinical conditions [stroke, myocardial infarction, coronary artery disease (CAD)]"|Baseline up to 6 months|||Percentage of participants||95% Confidence Interval|Number
681023|NCT01562548|Secondary|Global Assessment of Headache Intensity (GAHI)|Categorized after treatment as: ‘decreased’, ‘increased’ or ‘stayed the same’.|7 Days|Efficacy analysis were conducted on the intention-to-treat (ITT) population, defined as all subjects who received at least one dose of study medication and who had at least one post-baseline efficacy assessment.||participants|||Number
681024|NCT01562548|Secondary|Global Assessment of Headache Frequency (GAHF)|Categorized after treatment as: ‘decreased’, ‘increased’ or ‘stayed the same’.|7 Days|Efficacy analysis were conducted on the intention-to-treat (ITT) population, defined as all subjects who received at least one dose of study medication and who had at least one post-baseline efficacy assessment.||participants|||Number
681025|NCT01562548|Secondary|Global Assessment of Sleep Disturbance (GASD)|Categorized after treatment as: ‘decreased’, ‘increased’ or 'stayed the same’.|7 Days|Efficacy analysis were conducted on the intention-to-treat (ITT) population, defined as all subjects who received at least one dose of study medication and who had at least one post-baseline efficacy assessment.||participants|||Number
681026|NCT01562548|Secondary|Global Assessment of Treatment Helpfulness (GATH)|Measured as an overall qualitative score on a 5 point categorical scale: 0-poor, 1-fair, 2-good, 3-very good and 4-excellent.|4 Days, 7 Days|Efficacy analysis were conducted on the intention-to-treat (ITT) population, defined as all subjects who received at least one dose of study medication and who had at least one post-baseline efficacy assessment.||Score on a scale||Standard Deviation|Mean
681027|NCT01562548|Secondary|Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores|Vernon-Mior upper back/neck/shoulder components were assessed before the treatment and at Days 4 and 7. Each component (pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation) was assessed based on a 6-point categorical scale (1 to 6), with 1 being the most positive and 6 being the worst.|Before treatment, 4 Days, 7 Days|Efficacy analysis were conducted on the intention-to-treat (ITT) population, defined as all subjects who received at least one dose of study medication and who had at least one post-baseline efficacy assessment.||Score on a scale||Standard Deviation|Mean
681028|NCT01562548|Secondary|Muscle Relaxation Scores|The score was measured as mean of both AM and PM assessment scores at Days 4 and 7. Measurements were based on a 5 categorical scale: 0 - no relaxation, 1- a little relaxation, 2 - fair relaxation, 3 - good relaxation, 4 - complete muscle relaxation.|4 Days, 7 Days|Efficacy analysis were conducted on the intention-to-treat (ITT) population, defined as all subjects who received at least one dose of study medication and who had at least one post-baseline efficacy assessment.||Score on a scale||Standard Deviation|Mean
681029|NCT01562548|Secondary|Mean Change From Baseline of Both AM and PM NRS Discomfort Assessment Scores|The score was measured as 'assessment at baseline' minus 'assessment after treatment' over 7 day period (mean of all AM and PM changes from baseline). Measurements were based on an 11 categorical Numerical Rating Scale (NRS) with a range from 0 - no discomfort to 10 - unbearable discomfort.|7 Days|Efficacy analysis were conducted on the intention-to-treat (ITT) population, defined as all subjects who received at least one dose of study medication and who had at least one post-baseline efficacy assessment.||Score on a scale||Standard Deviation|Mean
681030|NCT01562548|Secondary|Mean Change From Baseline of Both AM and PM NRS Pain Assessment Scores|The score was measured as 'assessment at baseline' minus 'assessment after treatment' over 7 day period (mean of all AM and PM changes from baseline). Measurements were based on an 11 categorical Numerical Rating Scale (NRS) with a range from 0 - no pain to 10 - unbearable pain.|7 Days|Efficacy analysis were conducted on the intention-to-treat (ITT) population, defined as all subjects who received at least one dose of study medication and who had at least one post-baseline efficacy assessment.||Score on a scale||Standard Deviation|Mean
681031|NCT01562548|Secondary|Mean Change From Baseline of Both AM and PM NRS Tension Assessment Scores|The score was measured as 'assessment at baseline' minus 'assessment after treatment' over 7 day period (mean of all AM and PM changes from baseline). Measurements were based on an 11 categorical Numerical Rating Scale (NRS) with a range from 0 - no tension to 10 - unbearable tension.|7 Days|Efficacy analysis were conducted on the intention-to-treat (ITT) population, defined as all subjects who received at least one dose of study medication and who had at least one post-baseline efficacy assessment.||Score on a scale||Standard Deviation|Mean
683314|NCT01529385|Primary|Microcirculation for Medial Calf|microcirculation as measured by skin perfusion pressure|change from baseline after 4 weeks of sock usage|||mmHg||95% Confidence Interval|Mean
681033|NCT01562548|Primary|Mean Change From Baseline of Both AM and PM Spasm Assessment Scores|The score was measured as 'assessment at baseline' minus 'assessment after treatment' over 7 day period (mean of all AM and PM changes from baseline). Measurements were based on an 11 categorical Numerical Rating Scale (NRS) with a range from 0 - no spasm to 10 - unbearable spasm.|7 Days|Efficacy analysis was conducted on the intention-to-treat (ITT) population, defined as all subjects who received at least one dose of study medication and who had at least one post-baseline efficacy assessment. Subjects were analyzed according to the treatment to which they were randomized.||Score on a Scale||Standard Deviation|Mean
681034|NCT01562327|Secondary|Percentage of Participants With an Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with the study drug.|approximately 3 years|Safety population was defined as all participants who received at least one dose of Tocilizumab.||percentage of participants|||Number
681035|NCT01562327|Secondary|Change From Baseline in Patient's Severity of Morning Stiffness at Month 3 and Month 6|Morning stiffness was defined by the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was as limber as he/she would be during a day involving typical activities. Morning stiffness was assessed on a 100 mm VAS, where 0= none and 100= very severe.|Baseline, Month 3, Month 6|FAS was defined as all participants who received at least one dose of Tocilizumab. Here, 'n' represents the number of participants with a measurement at the specified time point.||units on a scale||Full Range|Median
681036|NCT01562327|Secondary|Change From Baseline in Patient's Global Assessment of Pain at Month 3 and Month 6|The Patient Global Assessment of pain provides an overall assessment of the severity of pain that the participant is experiencing using a visual analogue score, where 0 indicates no pain and 100 indicates unbearable pain. A decrease in the score indicates improvement.|Baseline, Month 3, Month 6|FAS was defined as all participants who received at least one dose of Tocilizumab. Here, 'n' represents the number of participants with a measurement at the specified time point.||units on a scale||Full Range|Median
681037|NCT01562327|Secondary|Change From Baseline in Patient's Global Assessment of Fatigue at Month 3 and Month 6|The Patient Global Assessment of fatigue provides an overall assessment of the level of fatigue that the participant is experiencing using a visual analogue score, where 0 indicates no fatigue and 100 indicates extreme fatigue. A decrease in the score indicates improvement.|Baseline, Month 3, Month 6|FAS was defined as all participants who received at least one dose of Tocilizumab. Here, 'n' represents the number of participants with a measurement at the specified time point.||units on a scale||Full Range|Median
681038|NCT01562327|Secondary|Percentage of Participants With Clinical Remission in Health Assessment Questionnaire Disability Index (HAQ-DI)|The HAQ-DI was a participant self-reported questionnaire for assessing the extent of a participant’s functional ability. It consisted of 20 questions in 8 categories (dressing and grooming, rising, eating, walking, reach, grip, hygiene, and carrying out daily activities). Each question had 4 response options, ranging from 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. The HAQ-DI scale was an average of all the scores and ranged from 0 to 3, where higher scores represented higher disease activity.|Baseline, Month 3, Month 6|FAS was defined as all participants who received at least one dose of Tocilizumab. Here, 'n' represents the number of participants with a measure at the specified time point.||percentage of participants|||Number
681039|NCT01562327|Secondary|Change From Baseline in Patient's Global Assessment of Disease Activity at Month 3 and Month 6|The Patient Global Assessment of disease activity provides an overall assessment of how RA affects the participant using a visual analogue score, where 0 indicates they are managing very well and 100 indicates they are managing very poorly. A decrease in the score indicates improvement.|Baseline, Month 3, Month 6|FAS was defined as all participants who received at least one dose of Tocilizumab. Here, 'n' represents the number of participants with a measurement at the specified time point.||units on a scale||Full Range|Median
681040|NCT01562327|Secondary|Change From Baseline in Physician Global Assessment of Disease Activity at Month 3 and Month 6|"The physician's global assessment of disease activity was assessed using a 0 to 100 mm horizontal VAS by the physician. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). A negative change from Baseline indicated improvement."|Baseline, Month 3, Month 6|FAS was defined as all participants who received at least one dose of Tocilizumab. Here, 'n' represents the number of participants with a measurement at the specified time point.||units on a scale||Full Range|Median
681041|NCT01562327|Secondary|Percentage of Participants With American College of Rheumatology (ACR) Response at Month 3 and Month 6|ACR response was calculated based on total joint count evaluation (28 or 66/68 joint count) and other clinical and laboratory assessments. A positive ACR20 response required at least a 20% improvement (reduction) compared to baseline in swollen joint count (66 joints) and tender joint count (68 joints) and at least 3 of the following 5 assessments: patient's global assessment of pain, PGH, PhGH (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale), participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity), Acute phase reactant (CRP or ESR). A reduction in the level of and acute phase reactants was considered an improvement. ACR50, ACR70, ACR90 require a 50%, 70%, 90% improvement from baseline respectively.|Month 3, Month 6|FAS was defined as all participants who received at least one dose of Tocilizumab. Number of participants analyzed signifies the participants who were evaluable for this outcome measure. Here, 'n' represents the number of participants with a measure at the specified time point.||percentage of participants|||Number
681058|NCT01562327|Primary|Percentage of Participants on Tocilizumab Treatment at 6 Months After Treatment Initiation||6 months after treatment initiation|The Full Analysis Set (FAS) was defined as all participants who received at least one dose of Tocilizumab.||percentage of participants||95% Confidence Interval|Number
681094|NCT01562275|Secondary|Progression-Free Survival (PFS) Time for Participants With Measurable Disease According to RECIST v1.1|PFS is defined as the time from study treatment initiation to the first occurrence of disease progression, as determined by investigator review of tumor assessments using RECIST 1.1, or death from any cause during the study (i.e., within 30 days after the last dose of study treatment).|Screening, Days 21-28 of Cycle 2, Day 25 (± 3 days) of Cycle 4 and every 8 weeks thereafter till study completion (Up to 33 months)|This outcome measure was not analyzed as per changes in planned analysis due to very few participants with measurable response.|||||
681042|NCT01562327|Secondary|European League Against Rheumatism (EULAR) Response|Clinical response assessed as per EULAR categorical DAS28 response criteria was defined as clinically meaningful improvement at a particular time point. EULAR response was based on change from baseline (CFB) in the DAS28 score and also on the actual DAS28 score at the time point so was more reflective of the current status of the participant. The DAS28 score was a measure of the participant’s disease activity, based on the TJC (28 joints), SJC (28 joints), PGH, and ESR. DAS28 total scores ranged from 0 to approximately 10. Scores <2.6 = best disease control and scores >5.1 = worse disease control. A negative CFB indicated clinically meaningful improvement. EULAR Good response: DAS28 <=3.2 and a CFB <-1.2. EULAR Moderate response: DAS28 >3.2 to ≤ 5.1 or a CFB < -0.6 to ≥ -1.2. EULAR No response: DAS28 ≤3.2 or CFB greater than or equal to (>=) -0.6, DAS28 >3.2 to <=5.1 or CFB>=-0.6 and DAS28 >5.1 or CFB >=-0.6.|Month 3, Month 6|Data was not collected, hence not reported.|||||
681043|NCT01562327|Secondary|Simplified Disease Activity (SDAI) Response Classification|The SDAI was a combined index for measuring disease activity in RA which reflected the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PGH and PhGH, assessed on 0-100 mm VAS where 0 = no disease activity and 100 = worst disease activity, and C-reactive protein (CRP). SDAI total score = 0-86. A SDAI score </= 3.3 represented clinical remission, a score of between 3.4 and 11.0 represented low disease activity, a score between 11 and 26.0 represented moderate disease activity and a score > 26.0 represented high (or severe) disease.|Month 3, Month 6|Data was not collected, hence not reported.|||||
681044|NCT01562327|Secondary|Clinical Disease Activity Index (CDAI) Response Classification at Month 3 and Month 6|CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PGH and physician global assessment of disease activity (PhGH) assessed on 0-10 cm VAS; 0 = no disease activity and 10 = worst disease activity. CDAI total score = 0-76. CDAI <= 2.8 indicates clinical remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high (or severe) disease activity.|Month 3, Month 6|FAS was defined as all participants who received at least one dose of Tocilizumab. Number of participants analyzed signifies the participants who were evaluable for this outcome measure.||participants|||Number
681045|NCT01562327|Secondary|Disease Activity Score-28 (DAS 28) Response Classification at Month 3 and Moth 6|DAS28 was calculated from SJC and TJC using 28 joints count, erythrocyte sedimentation rate (ESR) (millimeter per hour [mm/hr]), and patient global assessment of disease activity (PGH) (measured on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0=no disease activity and 100=worst disease activity). DAS28 is a measurement of RA activity on a 0 to 10 scale: a score greater than (>) 5.1 indicates high disease activity; a score between 3.2 and 5.1 indicates moderate disease activity; a score of less than 3.2 indicates low disease activity; a score of less than (<) 2.6 is considered remission.|Month 3, Month 6|FAS was defined as all participants who received at least one dose of Tocilizumab. Number of participants analyzed signifies the participants who were evaluable for this outcome measure. Here, 'n' represents the number of participants with a measure at the specified time point.||participants|||Number
681046|NCT01562327|Secondary|Change From Baseline in Swollen Joint Count (SJC) at Month 3 and Month 6|The number of swollen joints was recorded on the joint assessment form, no swelling = 0, swelling =1, for 28 joints and were classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 28. A decrease in score indicates improvement.|Baseline, Month 3, Month 6|FAS was defined as all participants who received at least one dose of Tocilizumab. Here, 'n' represents the number of participants with a measure at the specified time point.||units on a scale||Full Range|Median
681047|NCT01562327|Secondary|Change From Baseline in Tender Joint Count (TJC) at Month 3 and Month 6|The number of tender joints was recorded on the joint assessment form, no tenderness = 0, tenderness = 1, for 28 joints and joints were classified as tender/not tender giving a total possible tender joint count score of 0 to 28. A decrease in score indicated improvement.|Baseline, Month 3, Month 6|FAS was defined as all participants who received at least one dose of Tocilizumab. Here, 'n' represents the number of participants with a measure at the specified time point.||units on a scale||Full Range|Median
681048|NCT01562327|Secondary|Percentage of Participants on Tocilizumab as Monotherapy or Combination Therapy|Percentage of participants on Tocilizumab as monotherapy or combination therapy (with DMARDs) were reported at start of treatment and at 6 months from the start of treatment.|Baseline, Month 6|FAS was defined as all participants who received at least one dose of Tocilizumab.||percentage of participants|||Number
681049|NCT01562327|Secondary|Percentage of Participants Who Discontinued From Tocilizumab for Safety Versus Efficacy||Approximately 3 years|FAS was defined as all participants who received at least one dose of Tocilizumab.||percentage of participants|||Number
681050|NCT01562327|Secondary|Reasons for Dose Modifications||approximately 3 years|FAS was defined as all participants who received at least one dose of Tocilizumab.||participants|||Number
681051|NCT01562327|Secondary|Reason for Biologic Agent Withdrawal at Baseline||Baseline|FAS defined as all participants who received at least one dose of Tocilizumab. Number of participants analyzed signifies the participants who were evaluable for this outcome measure.||participants|||Number
681052|NCT01562327|Secondary|Percentage of Participants Who Previously Received Biologic Agents||Baseline|FAS was defined as all participants who received at least one dose of Tocilizumab.||percentage of participants|||Number
681053|NCT01562327|Secondary|Number of Participants Who Stopped Biologic Agents Prior to Start of Tocilizumab||Baseline|FAS was defined as all participants who received at least one dose of Tocilizumab.||participants|||Number
681054|NCT01562327|Secondary|Reason for DMARDs Withdrawal at Baseline||Baseline|FAS defined as all participants who received at least one dose of Tocilizumab. Number of participants analyzed signifies the participants who were evaluable for this outcome measure.||participants|||Number
681055|NCT01562327|Secondary|Percentage of Participants Who Previously Received DMARDs||Baseline|FAS was defined as all participants who received at least one dose of Tocilizumab.||percentage of participants|||Number
681056|NCT01562327|Secondary|Number of Participants Who Stopped Disease-Modifying Antirheumatic Drugs (DMARDs) Prior to Start of Tocilizumab||Baseline|FAS was defined as all participants who received at least one dose of Tocilizumab.||participants|||Number
681074|NCT01562314|Secondary|Plasma Endocannabinoid Levels - Oleoylethanolamide (OEA)|Change from baseline in the endocannabinoid OEA|Baseline to end of treatment (10 weeks treatment period)|ITT analysis set||nmol/L||Standard Deviation|Mean
681059|NCT01562314|Post-Hoc|Mayo Partial Score - PP Analysis Set|"Change in Mayo partial score from Baseline to Final Visit.
The Mayo score is an assessment of ulcerative colitis activity, with higher scores indicating more severe disease. The Mayo total score (range 0-12 points) is made up of four sub-scores (stool frequency, rectal bleeding, endoscopy findings and the physicians assessment of illness severity); each carrying equal numerical weight (0-3 points).
The Mayo partial score does not include the endoscopy findings sub-score, and is calculated by summing the remaining three sub-scores (stool frequency, rectal bleeding and PGAS) to give a value ranging from 0-9 points. As with the Mayo total score, higher Mayo partial scores indicate more severe disease."|Baseline to end of treatment (10 weeks treatment period)|PP Analysis Set||Points on a scale||Standard Deviation|Mean
681060|NCT01562314|Secondary|Clinical Body Weight Assessment|Change in body weight from Baseline to Final Visit|Baseline to end of treatment (10 weeks treatment period)|ITT analysis set||Kg||Standard Deviation|Mean
681061|NCT01562314|Primary|Percentage of Participants Achieving Remission Quantified as a Mayo Score of 2 or Less (With no Sub-score >1) - PP Analysis Set|The Mayo score is an assessment of ulcerative colitis activity, with higher scores indicating more severe disease. The Mayo total score (range 0-12 points) is made up of four sub-scores (stool frequency, rectal bleeding, endoscopy findings and the physicians assessment of illness severity); each carrying equal numerical weight (0-3 points).|Baseline to end of treatment (10 weeks treatment period)|Per protocol (PP) analysis set||percentage of participants|||Number
681062|NCT01562314|Post-Hoc|Mayo Score: Responder Analysis - PP Analysis|"Proportion of participants responding between Baseline and Final Visit.
The Mayo score is an assessment of ulcerative colitis activity, with higher scores indicating more severe disease. The Mayo total score (range 0-12 points) is made up of four sub-scores (stool frequency, rectal bleeding, endoscopy findings and the physicians assessment of illness severity); each carrying equal numerical weight (0-3 points).
A responder was defined as a participant with a decrease in their Mayo total score of ≥3 points, compared to baseline, with a reduction of at least 1 point in endoscopy findings sub-score."|Baseline to end of treatment (10 weeks treatment period)|PP analysis set||% of participants|||Number
681063|NCT01562314|Post-Hoc|Mayo Total Score - PP Analysis|"Change in Mayo total score from Baseline to Final Visit.
The Mayo score is an assessment of ulcerative colitis activity, with higher scores indicating more severe disease. The Mayo total score (range 0-12 points) is made up of four sub-scores (stool frequency, rectal bleeding, endoscopy findings and the physicians assessment of illness severity); each carrying equal numerical weight (0-3 points)."|Baseline to end of treatment (10 weeks treatment period)|PP analysis set||Points on a scale||Standard Deviation|Mean
681064|NCT01562314|Post-Hoc|Ulcerative Colitis Symptom Measures - Pain - PP Analysis|"Change in Pain from Baseline to end of treatment.
Pain scores using a 0-10 numerical rate scale (0 = no pain; 10 = pain as bad as you can imagine) were recorded in daily diaries, by participants, during the baseline and treatment periods. For analysis the baseline value is defined as the mean pain score of the last seven available days of the baseline period; the end of treatment value is defined as the mean pain score of last seven days of the treatment period."|Baseline to end of treatment (10 weeks treatment period)|PP analysis set||Points on a scale||Standard Deviation|Mean
681065|NCT01562314|Post-Hoc|Clinical Efficacy Stool Sample Measurements - PP Analysis|Change in faecal inflammatory marker calprotectin from Baseline to Final Visit|Baseline to end of treatment (10 weeks treatment period)|PP analysis set||ug/g||Standard Deviation|Mean
681066|NCT01562314|Post-Hoc|Clinical Efficacy Blood Sample Measurements - TNF - PP Analysis|Change in serum cytokine TNF-alpha from Baseline to Final Visit|Baseline to end of treatment (10 weeks treatment period)|PP analysis set||pg/mL||Standard Deviation|Mean
681067|NCT01562314|Post-Hoc|Clinical Efficacy Blood Sample Measurements - IL-6 - PP Analysis|Change in serum cytokine IL-6 from Baseline to Final Visit.|Baseline to end of treatment (10 weeks treatment period)|PP analysis set||ng/L||Standard Deviation|Mean
681068|NCT01562314|Post-Hoc|Clinical Efficacy Blood Sample Measurements - IL-2 - PP Analysis|Change in serum cytokine IL-2 from Baseline to Final Visit|Baseline to end of treatment (10 weeks treatment period)|PP analysis set||ng/L||Standard Deviation|Mean
681069|NCT01562314|Post-Hoc|Clinical Efficacy Blood Sample Measurements - CRP - PP Analysis|Change in serum CRP from Baseline to Final Visit|Baseline to end of treatment (10 weeks treatment period)|PP analysis set||mg/L||Standard Deviation|Mean
681070|NCT01562314|Secondary|Mayo Score: Responder Analysis|"Proportion of participants responding between Baseline and Final Visit
The Mayo score is an assessment of ulcerative colitis activity, with higher scores indicating more severe disease. The Mayo total score (range 0-12 points) is made up of four sub-scores (stool frequency, rectal bleeding, endoscopy findings and the physicians assessment of illness severity); each carrying equal numerical weight (0-3 points).
A responder was defined as a participant with a decrease in their Mayo total score of ≥3 points, compared to baseline, with a reduction of at least 1 point in endoscopy findings sub-score."|Baseline to end of treatment (10 weeks treatment period)|ITT analysis set||% of participants|||Number
681071|NCT01562314|Secondary|Mayo Partial Score|"Change in Mayo partial score from Baseline to Final Visit.
The Mayo score is an assessment of ulcerative colitis activity, with higher scores indicating more severe disease. The Mayo total score (range 0-12 points) is made up of four sub-scores (stool frequency, rectal bleeding, endoscopy findings and the physicians assessment of illness severity); each carrying equal numerical weight (0-3 points).
The Mayo partial score does not include the endoscopy findings sub-score, and is calculated by summing the remaining three sub-scores (stool frequency, rectal bleeding and PGAS) to give a value ranging from 0-9 points. As with the Mayo total score, higher Mayo partial scores indicate more severe disease."|Baseline to end of treatment (10 weeks treatment period)|ITT Analysis Set||Points on a scale||Standard Deviation|Mean
681072|NCT01562314|Secondary|Mayo Total Score|"Change in Total Mayo score from Baseline to Final Visit.
The Mayo score is an assessment of ulcerative colitis activity, with higher scores indicating more severe disease. The Mayo total score (range 0-12 points) is made up of four sub-scores (stool frequency, rectal bleeding, endoscopy findings and the physicians assessment of illness severity); each carrying equal numerical weight (0-3 points)."|Baseline to end of treatment (10 weeks treatment period)|ITT analysis set||Points on a scale||Standard Deviation|Mean
681073|NCT01562314|Secondary|Plasma Endocannabinoid Levels - PEA|Change from baseline in the endocannabinoid PEA|Baseline to end of treatment (10 weeks treatment period)|ITT analysis set||nmol/L||Standard Deviation|Mean
681077|NCT01562314|Secondary|Ulcerative Colitis Symptom Measures - Rectal Bleeding - PP Analysis|"Change in rectal bleeding from Baseline to end of treatment.
Rectal bleeding scores using a 0-4 numerical rate scale (0 = No blood seen; 1 = Streaks of blood with stool less than half the time; 2 = Obvious blood with stool most of the time or more; 3 = Blood alone passes) were recorded in daily diaries, by participants, during the baseline and treatment periods. For analysis the baseline value is defined as the mean rectal bleeding score of the last seven available days of the baseline period; the end of treatment value is defined as the mean rectal bleeding score of last seven days of the treatment period."|Baseline to end of treatment (10 weeks treatment period)|PP analysis set||Points on a scale||Standard Deviation|Mean
681078|NCT01562314|Secondary|Ulcerative Colitis Symptom Measures - Rectal Bleeding|"Change in rectal bleeding from Baseline to end of treatment.
Rectal bleeding scores using a 0-4 numerical rate scale (0 = No blood seen; 1 = Streaks of blood with stool less than half the time; 2 = Obvious blood with stool most of the time or more; 3 = Blood alone passes) were recorded in daily diaries, by participants, during the baseline and treatment periods. For analysis the baseline value is defined as the mean rectal bleeding score of the last seven available days of the baseline period; the end of treatment value is defined as the mean rectal bleeding score of last seven days of the treatment period."|Baseline to end of treatment (10 weeks treatment period)|ITT analysis set||Points on a scale||Standard Deviation|Mean
681079|NCT01562314|Secondary|Ulcerative Colitis Symptom Measures - Stool Frequency - PP Analysis|"Change in stool frequency from Baseline to end of treatment.
Stool frequency scores using a 0-4 numerical rate scale (0 = Normal number of stools; 1 = 1-2 stools more than normal; 2 = 3-4 stools more than normal; 3 = 5 or more stools more than normal) were recorded in daily diaries, by participants, during the baseline and treatment periods. For analysis the baseline value is defined as the mean stool frequency score of the last seven available days of the baseline period; the end of treatment value is defined as the mean stool frequency score of last seven days of the treatment period."|Baseline to end of treatment (10 weeks treatment period)|PP analysis set||Points on a scale||Standard Deviation|Mean
681080|NCT01562314|Secondary|Ulcerative Colitis Symptom Measures - Stool Frequency|"Change in stool frequency from Baseline to end of treatment.
Stool frequency scores using a 0-4 numerical rate scale (0 = Normal number of stools; 1 = 1-2 stools more than normal; 2 = 3-4 stools more than normal; 3 = 5 or more stools more than normal) were recorded in daily diaries, by participants, during the baseline and treatment periods. For analysis the baseline value is defined as the mean stool frequency score of the last seven available days of the baseline period; the end of treatment value is defined as the mean stool frequency score of last seven days of the treatment period."|Baseline to end of treatment (10 weeks treatment period)|ITT analysis set||Points on a scale||Standard Deviation|Mean
681081|NCT01562314|Secondary|Ulcerative Colitis Symptom Measures - Pain|"Change in Pain from Baseline to end of treatment.
Pain scores using a 0-10 numerical rate scale (0 = no pain; 10 = pain as bad as you can imagine) were recorded in daily diaries, by participants, during the baseline and treatment periods. For analysis the baseline value is defined as the mean pain score of the last seven available days of the baseline period; the end of treatment value is defined as the mean pain score of last seven days of the treatment period."|Baseline to end of treatment (10 weeks treatment period)|ITT analysis set||Points on a scale||Standard Deviation|Mean
681082|NCT01562314|Secondary|Clinical Assessments - PGAS - PP Analysis|"Change in PGAS from Baseline to Final Visit.
The PGAS required the physician to assess participants' disease severity on a four point scale (0=normal, 1=mild disease, 2=moderate disease, 3=severe disease)."|Baseline to end of treatment (10 weeks treatment period)|PP analysis set||Points on a scale||Standard Deviation|Mean
681083|NCT01562314|Secondary|Clinical Assessments - Physician's Global Assessment of Illness Severity (PGAS)|"Change in PGAS from Baseline to Final Visit.
The PGAS required the physician to assess participants’ disease severity on a four point scale (0=normal, 1=mild disease, 2=moderate disease, 3=severe disease)."|Baseline to end of treatment (10 weeks treatment period)|ITT analysis set||Points on a scale||Standard Deviation|Mean
681084|NCT01562314|Secondary|Clinical Assessments - SGIC - PP Analysis|"SGIC - percentage of participants showing improvement at Final Visit.
Participants were asked to assess the status of their ulcerative colitis since study entry using a seven-point scale (very much improved; much improved; minimally improved; no change; minimally worse; much worse; very much worse)."|Baseline to end of treatment (10 weeks treatment period)|PP analysis set||% of participants|||Number
681085|NCT01562314|Secondary|Clinical Assessments - Subject Global Impression of Change (SGIC)|"SGIC - percentage of participants reporting improvement at Final Visit.
Participants were asked to assess the status of their ulcerative colitis since study entry using a seven-point scale (very much improved; much improved; minimally improved; no change; minimally worse; much worse; very much worse)."|Baseline to end of treatment (10 weeks treatment period)|ITT analysis set||% of participants|||Number
681086|NCT01562314|Secondary|Clinical Assessments - IBDQ - PP Analysis|"Change in IBDQ total score from Baseline to Final Visit.
The IBDQ is a validated and reliable tool to measure health-related quality of life in adult patients with inflammatory bowel disease. Each of the 32 questions falls into one of four domains (bowel symptoms, systemic symptoms, emotional status and social functioning). All questions were scored out of seven, with higher scores attributed to increasingly favourable responses; accordingly, any increase in score signified an improvement in condition. Individual question scores were summed to give the IBDQ total score (range: 32-224 points)."|Baseline to end of treatment (10 weeks treatment period)|PP analysis set||Points on a scale||Standard Deviation|Mean
681087|NCT01562314|Secondary|Clinical Assessments - Inflammatory Bowel Disease Questionnaire (IBDQ)|"Change in IBDQ total score from Baseline to Final Visit.
The IBDQ is a validated and reliable tool to measure health-related quality of life in adult patients with inflammatory bowel disease. Each of the 32 questions falls into one of four domains (bowel symptoms, systemic symptoms, emotional status and social functioning). All questions were scored out of seven, with higher scores attributed to increasingly favourable responses; accordingly, any increase in score signified an improvement in condition. Individual question scores were summed to give the IBDQ total score (range: 32-224 points)."|Baseline to end of treatment (10 weeks treatment period)|ITT analysis set||Points on a scale||Standard Error|Mean
681088|NCT01562314|Secondary|Clinical Efficacy Stool Sample Measurements|Change in faecal inflammatory marker calprotectin from Baseline to Final Visit|Baseline to end of treatment (10 weeks treatment period)|ITT analysis set||ug/g||Standard Deviation|Mean
681095|NCT01562275|Secondary|Duration of Objective Response for Participants With Measurable Disease According to RECIST v1.1|Duration of response, defined as the time from first occurrence of a documented objective response until the time of disease progression, as determined by investigator review of tumor assessments using RECIST 1.1, or death from any cause during the study (i.e., within 30 days after the last dose of study treatment).|Screening, Days 21-28 of Cycle 2, Day 25 (± 3 days) of Cycle 4 and every 8 weeks thereafter till study completion (Up to 33 months)|This outcome measure was not analyzed as per changes in planned analysis due to very few participants with measurable response.|||||
681096|NCT01562275|Secondary|Number of Participants With Objective Response of Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)|RECIST v1.1 (for measurable disease), CR: disappearance of all target lesions, reduction in short axis <10 millimeters in pathological lymph nodes (target and non-target lesions); PR: at least a 30 percent (%) decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Responses were confirmed by repeat assessments ≥4 weeks after initial documentation.|Screening, Days 21-28 of Cycle 2, Day 25 (± 3 days) of Cycle 4 and every 8 weeks thereafter till study completion (Up to 33 months)|Safety analysis population.||participants|||Number
681097|NCT01562275|Secondary|Last Measurable Concentration (Clast) of Ipatasertib and Cobimetinib on Day 1 and Day 15||Predose (0 hour), 1, 2, 4, 6 and 24 hours postdose on Day 1 and Day 15 of Cycle 1|"Pharmacokinetic analysis population. n represents the number of participants who were evaluable for that particular assessment."||ng/mL||Standard Deviation|Mean
681098|NCT01562275|Secondary|Time Taken to Reach Cmax (Tmax) of Ipatasertib and Cobimetinib on Day 1 and Day 15||Predose (0 hour), 1, 2, 4, 6 and 24 hours postdose on Day 1 and Day 15 of Cycle 1|"Pharmacokinetic analysis population. n represents the number of participants who were evaluable for that particular assessment."||hours||Full Range|Median
681099|NCT01562275|Secondary|Maximum Plasma Concentration (Cmax) of Ipatasertib and Cobimetinib on Day 1 and Day 15||Predose (0 hour), 1, 2, 4, 6 and 24 hours postdose on Day 1 and Day 15 of Cycle 1|"Pharmacokinetic analysis population. n represents the number of participants who were evaluable for that particular assessment."||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
681100|NCT01562275|Secondary|Area Under Concentration-Time Curve From Time Zero to Last Measurable Concentration After Dose [AUC0–Last] of Ipatasertib and Cobimetinib on Day 1 and Day 15||Predose (0 hour), 1, 2, 4, 6 and 24 hours postdose on Day 1 and Day 15 of Cycle 1|"Pharmacokinetic analysis population: Included all participants who received study treatment and had at least 1 cobimetinib and ipatasertib plasma concentration available. n represents the number of participants who were evaluable for that particular assessment."||nanograms*hours/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
681101|NCT01562275|Primary|Number of Participants With At Least One AE Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version (V) 4.0|AE was defined in Outcome Measure 3. AEs were graded as per NCI CTCAE V 4.0 as follows: G 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; G 2: minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily living (ADL) (instrumental ADL refers to preparing meals, shopping for groceries or clothes, using the telephone, managing money and others); G 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated, disabling, limiting self care ADL (refers to bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden); G 4: Life-threatening consequences, urgent intervention indicated; G 5: Death related to AE. If a participant had multiple events of different grades, the highest grade that occurred in that participant was counted.|From Baseline up to 30 days after the last dose of study treatment or until initiation of another anticancer treatment whichever occurred first (Up to 33 months)|Safety analysis population.||participants|||Number
681102|NCT01562275|Primary|Maximum Tolerated Doses (MTDs) in Combination of Cobimetinib and Ipatasertib During Dose-Escalation Stage 1|An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. On the basis of AEs that did not meet protocol-defined DLT criteria (defined in Outcome measure 1) but indicated intolerability of a given dose combination, the combination MTDs were determined (as per investigator) during Stage 1 of the study.|Cycle 1 (28 Days)|Safety analysis population participants from dose escalation cohorts.||milligrams|||Number
681103|NCT01562275|Primary|Number of DLTs Categorized as Per the Nature|DLT is defined as 1 of the following toxicities considered by the investigator to be possibly related to study drugs: a) G ≥3 febrile neutropenia, b) G ≥4 neutropenia (ANC <500/μL) lasting >5 days , c) G ≥4 thrombocytopenia lasting >2 days, d) G ≥4 anemia, e) G ≥3 elevation of total bilirubin or hepatic transaminase or ALP lasting >3 days, f) Hepatic transaminases >3 × ULN and an increase in total bilirubin >2 × ULN without any findings of cholestasis and in the absence of other contributory factors, g) G ≥2 visual changes that do not resolve to baseline within 14 days, h) 1 episode of fasting G 4 hyperglycemia or 3 episodes of fasting, i) G 3 hyperglycemia on separate days within 7 days, j) G ≥4 fasting hypercholesterolemia or triglyceridemia for ≥2 weeks, k) G ≥3 nausea, vomiting, or diarrhea despite maximal supportive medications lasting for ≥3 days. Hematologic, Hepatic and non-hematologic and non-hepatic DLT categories were to be reported.|Cycle 1 (28 Days)|Data for this outcome measure was not analyzed as no participant experienced DLT.|||||
681104|NCT01562275|Primary|Number of Participants With Dose Limiting Toxicities (DLTs)|DLT is defined as 1 of the following toxicities considered by the investigator to be possibly related to study drugs: a) Grade (G) ≥3 febrile neutropenia, b) G ≥4 neutropenia (absolute neutrophil count [ANC] <500/ microliter [μL]) lasting >5 days , c) G ≥4 thrombocytopenia lasting >2 days, d) G ≥4 anemia, e) G ≥3 elevation of total bilirubin or hepatic transaminase or alkaline phosphatase (ALP) lasting >3 days, f) Hepatic transaminases >3 × Upper Limit of Normal (ULN) and an increase in total bilirubin >2 × ULN without any findings of cholestasis and in the absence of other contributory factors, g) G ≥2 visual changes that do not resolve to baseline within 14 days, h) 1 episode of fasting G 4 hyperglycemia or 3 episodes of fasting, i) G 3 hyperglycemia on separate days within 7 days, j) G ≥4 fasting hypercholesterolemia or triglyceridemia for ≥2 weeks, k) G ≥3 nausea, vomiting, or diarrhea despite maximal supportive medications lasting for ≥3 days.|Cycle 1 (28 Days)|Safety analysis set included all participants who received at least 1 dose of study treatment. This outcome was analyzed in safety analysis population participants in dose escalation cohorts.||participants|||Number
681105|NCT01562132|Secondary|Cryptococcal Meningitis-free Survival at 24 Weeks|"Clinical meningitis AND at least one of the following: cryptococcal antigen in the cerebrospinal fluid (CSF), cryptococcal organisms on India Ink stain, or fungal culture of CSF.
Clinical meningitis will be defined as:
fever>39.0°C, AND
severe headache, AND
At least one of the following:
meningismus,
photophobia,
new onset seizure,
focal neurological deficit localizable to the central nervous system
papilledema
confusion, delirium, or decreased level of consciousness."|24 weeks||||||
681106|NCT01562132|Secondary|Number of Individuals With Treatment Related Serious Adverse Events||24 weeks||||||
681107|NCT01562132|Secondary|Number of Individuals With Treatment Related Adverse Events||24 weeks||||||
681108|NCT01562132|Secondary|Proportion of Individuals Requiring Dose Reduction||24 weeks||||||
681109|NCT01562132|Secondary|Proportion of Individuals Requiring Treatment Discontinuation||4 weeks||||||
681110|NCT01562132|Secondary|Achieve Targeted Recruitment, Retention and Adherence Rates||24 weeks||||||
681111|NCT01562132|Secondary|Number of Individuals Who Develop Immune Reconstitution Inflammatory Syndrome Due to Cryptococcus|"Individuals who develop clinical meningitis without evidence of fungal, bacterial, or parasitic (e.g. malaria) organisms in the cerebrospinal fluid. Clinical meningitis will be defined as:
fever>39.0°C, AND
severe headache, AND
At least one of the following:
meningismus,
photophobia,
new onset seizure,
focal neurological deficit localizable to the central nervous system
papilledema
confusion, delirium, or decreased level of consciousness."|24 weeks||||||
681112|NCT01562132|Secondary|Number of Individuals Who Develop Cryptococcal Meningitis|"Clinical meningitis AND at least one of the following: cryptococcal antigen in the cerebrospinal fluid (CSF), cryptococcal organisms on India Ink stain, or fungal culture of CSF.
Clinical meningitis will be defined as:
fever>39.0°C, AND
severe headache, AND
At least one of the following:
meningismus,
photophobia,
new onset seizure,
focal neurological deficit localizable to the central nervous system
papilledema
confusion, delirium, or decreased level of consciousness."|24 weeks||||||
681113|NCT01562132|Secondary|Survival at 24 Weeks||24 weeks||||||
681114|NCT01562132|Secondary|Survival at 2 Weeks||2 weeks||||||
681115|NCT01562132|Primary|Survival at 12 Weeks||12 weeks|||participants|||Number
681116|NCT01561898|Primary|Incidence of Adverse Events|The incidence of adverse events was measured by the percentage of patients who presented one or more adverse events.|48 weeks|Intent-to-treat (ITT) population||percentage of patients|||Number
681117|NCT01561898|Secondary|Change From Baseline in Clinical Global Impression - Severity (CGI-S)|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a patient. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill patients."|Baseline, Week 48|Intent-to-treat (ITT) population||scores on a scale||Standard Deviation|Mean
681118|NCT01561898|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS)|PANSS is a medical scale that assesses various symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill).|Baseline, Week 48|Intent-to-treat (ITT) population||scores on a scale||Standard Deviation|Mean
681119|NCT01561716|Primary|Energy Expenditure|Energy expenditure is measured using continuous, computerized open-circuit indirect calorimetry (oxygen consumption and carbon dioxide production) and converted to metabolic equivalents (METs).|30 min continuous monitoring at rest and during each physical activity|||METs||Standard Deviation|Mean
681120|NCT01561703|Primary|Healthcare Utilization|Questionnaire designed to evaluate healthcare utilization following surgery. Unit of measure will be the number of participants utilizing each category of healthcare.|6 wks post-operative appointment|||participants|||Number
681121|NCT01561560|Primary|End-of-day Comfort|"End-of-day comfort was interpreted and reported by the participant on a questionnaire as a single, retrospective measurement of two weeks of wear. Participants were asked, Please rate the study lenses you have been wearing the in the following area: End-of-day comfort and recorded their response on a continuous 1-10 Likert scale (1=poor and 10=excellent)."|Week 2|This reporting group includes all participants who finished the study, minus any major protocol deviations as determined by masked review.||Units on a scale||Standard Deviation|Mean
681122|NCT01561469|Secondary|Number of Antibiotic Free Days||Up to 28 days after diagnosis of VAP|Data was not analyzed for this outcome because other reported measures (that is, duration of antimicrobial treatment, duration of mechanical ventilation, duration of ICU stay, duration of hospital stay) were considered to represent a more strict and useful reflection of resource utilization.|||||
681123|NCT01561469|Secondary|Duration of Antimicrobial Treatment||Up to 28 days after diagnosis of VAP|Analysis population included all participants who met the eligibility criteria for this study.||days||Standard Deviation|Mean
681124|NCT01561469|Secondary|Duration of Mechanical Ventilation|Duration of mechanical ventilation was assessed as number of days from VAP diagnosis to extubation or to discharge if not extubated.|Up to 28 days after diagnosis of VAP|Analysis population included all participants who met the eligibility criteria for this study.||days||Inter-Quartile Range|Median
681125|NCT01561469|Secondary|Duration of Intensive Care Unit (ICU) Stay|Duration of ICU stay was assessed as number of days from VAP diagnosis to discharge from the ICU.|Up to 28 days after diagnosis of VAP|Analysis population included all participants who met the eligibility criteria for this study.||days||Inter-Quartile Range|Median
681126|NCT01561469|Secondary|Duration of Hospital Stay|Duration of hospital stay was assessed as number of days from VAP diagnosis to discharge from the hospital.|Up to 28 days after diagnosis of VAP|Analysis population included all participants who met the eligibility criteria for this study.||days||Inter-Quartile Range|Median
681127|NCT01561469|Secondary|Number of Participants With Microbiological Outcome|Microbiological outcome was defined as superinfections (infections diagnosed within 72 hours of the diagnosis of HAP and until day 28) and colonization (positive cultures with a multi-drug resistant organism).|28 days after diagnosis of VAP|Analysis population included all participants who met the eligibility criteria for this study.||participants|||Number
681128|NCT01561469|Primary|Percentage of Participants With Clinical Success|Clinical success was assessed as number of participants cured or improved. Cure = complete resolution of signs and symptoms of pneumonia; Improvement = partial resolution of signs and symptoms of pneumonia.|14 days after diagnosis with VAP or hospital discharge, whichever occurred first|Analysis population included all participants who met the eligibility criteria for this study.||percentage of participants|||Number
681129|NCT01561313|Secondary|Number of Participants With Adverse Events (AEs)|An AE was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment.|Adverse events were collected from the time of study drug administration until 70 days following discontinuation of study drug. Serious Adverse Events were collected from the time the participant signed the informed consent.|||participants|||Number
681130|NCT01561313|Secondary|Percentage of Participants With no Pruritus in the Draize Scale|Pruritus (itching) was assessed.|10 minutes and 30 minutes after injection|||Percentage of Participants|||Number
681131|NCT01561313|Secondary|Percentage of Participants With no Edema in the Draize Scale|Edema (swelling) was assessed.|10 minutes and 30 minutes after injection|||Percentage of Participants|||Number
681132|NCT01561313|Secondary|Percentage of Participants With no Erythema in the Draize Scale|Erythema (redness) was assessed.|10 minutes and 30 minutes after injection|||Percentage of Participants|||Number
681133|NCT01561313|Secondary|Percentage of Participants With no Hemorrhage/Petechiae in the Draize Scale|Hemorrhage/petechiae (bleeding/spots of bleeding underneath the skin) was assessed.|10 minutes and 30 minutes after injection|||Percentage of Participants|||Number
681134|NCT01561313|Secondary|Mean Injection Site Pain on a Visual Analogue Scale (VAS)|The secondary response variable is participant's pain of injection on a visual analogue scale (VAS) of 0 to 10 (cm) recorded 15 minutes after the injection, with 0 representing no pain and 10 representing the worst possible pain.|15 minutes post injection|||cm||Standard Deviation|Mean
681135|NCT01561313|Primary|Mean Injection Site Pain on a Visual Analogue Scale (VAS)|The primary response variable is participant's immediate pain of injection on a visual analogue scale (VAS) of 0 to 10 (cm), with 0 representing no pain and 10 representing the worst possible pain.|Immediately after injection|||cm||Standard Deviation|Mean
681136|NCT01561300|Secondary|Chronic Effect of Tea vs Control|"Change in flow mediated dilation (FMD) due to tea consumption when compared to control.
FMD measurement included the following steps:
1 minute base scan to measure the baseline diameter of artery (baseline)
5 minutes of forearm occlusion at 300±30 mmHg, just below the elbow 2-5 cm from antecubital crease
4 minutes FMD scan, which started immediately after release of the occlusion (reactive hyperaemia stage) FMD was calculated as maximal percentage change in diameter of the artery above the baseline value after the release of the occlusion"|From baseline at day 1 to baseline on day 8|Per protocol based on the full data set excluding one subject who did produce relevant data (AE) and three subjects who were removed during blind review (operator comments, hypertension and increase in body weight). Single data points were removed for 6 subjects (all single data points) based on operator comments.||Percentage change in flow mediated dilat||95% Confidence Interval|Least Squares Mean
681137|NCT01561300|Secondary|Acute Effect of Tea vs Control|"Change in flow mediated dilation due to tea consumption when compared to control.
FMD measurement included the following steps:
1 minute base scan to measure the baseline diameter of artery (baseline)
5 minutes of forearm occlusion at 300±30 mmHg, just below the elbow 2-5 cm from antecubital crease
4 minutes FMD scan, which started immediately after release of the occlusion (reactive hyperaemia stage) FMD was calculated as maximal percentage change in diameter of the artery above the baseline value after the release of the occlusion"|From baseline on day 1 to 2 hours post consumption on day 1|Per protocol based on the full data set excluding one subject who did produce relevant data (AE) and three subjects who were removed during blind review (operator comments, hypertension and increase in body weight). Single data points were removed for 6 subjects (all single data points) based on operator comments.||percent change in flow mediated dilation||95% Confidence Interval|Least Squares Mean
681138|NCT01561300|Primary|'Acute-upon-chronic Effect' of Tea vs Control|"Change in flow mediated dilation (FMD) due to tea consumption when compared to control.
FMD measurement included the following steps:
1 minute base scan to measure the baseline diameter of artery (baseline)
5 minutes of forearm occlusion at 300±30 mmHg, just below the elbow 2-5 cm from antecubital crease
4 minutes FMD scan, which started immediately after release of the occlusion (reactive hyperaemia stage) FMD was calculated as maximal percentage change in diameter of the artery above the baseline value after the release of the occlusion"|Baseline day 1 to 2 hours post consumption on day 8.|Per protocol based on the full data set excluding one subject who did produce relevant data (AE) and three subjects who were removed during blind review (operator comments, hypertension and increase in body weight). Single data points were removed for 6 subjects (all single data points) based on operator comments.||percentage of change in diameter||95% Confidence Interval|Least Squares Mean
681139|NCT01561079|Primary|Fetal Movement - Fetal Heart Rate Coupling|The integration between fetal movements and heart rate (FM-FHR coupling) was quantified as the proportion of time individual movements were associated with a change in FHR, using previously developed criteria. FM-FHR coupling reflects coactivation of the sympathetic and parasympathetic components of the autonomic nervous system.|24, 28, 32, 36 weeks of gestation|||percentage of time FM assoc w FHR change||Standard Deviation|Mean
681140|NCT01561079|Primary|Fetal Movement|Fetal movement (number x duration of fetal movements) during the 60 minute recordings at times of trough and peak maternal buprenorphine levels|24, 28, 32, 36 weeks of gestation|||seconds||Standard Deviation|Mean
681141|NCT01561079|Primary|Accelerations of Fetal Heart Rate|Number of accelerations of fetal heart rate exhibited during the 60 minute recordings|24, 28, 32 36 weeks of gestation|||accelerations||95% Confidence Interval|Mean
681142|NCT01561079|Primary|Fetal Heart Rate Variability|Fetal heart rate variability at 24, 28, 32 and 36 weeks of gestation at times of trough and peak maternal buprenorphine levels|24, 28, 32 and 36 weeks of gestation|Per protocol||msec||Standard Deviation|Mean
681143|NCT01561079|Primary|Fetal Heart Rate|Fetal heart rate in beats per minute at time of trough and peak maternal buprenorphine levels|24, 28, 32 and 36 weeks of gestation|Participants active in the protocol at 24, 28, 32 and 36 weeks, respectively||beats per minute||Standard Deviation|Mean
681154|NCT01560975|Primary|Relationship Between IOP Fluctuation Pattern With or Without CPAP Therapy in Patients With Moderate to Severe OSAS With or Without POAG|"24-hour IOP fluctuation pattern recorded using Triggerfish in patients with moderate to severe OSAS.
using CPAP in patients with or without POAG
not using CPAP in patients with or without POAG"|24 hours|||mVEq/h||Standard Deviation|Mean
681793|NCT01550952|Primary|Anterior Deltoid Strength|Anterior deltoid strength as measured by a dynamometer. Percentage change in measure as compared to post-surgery (with post-surgery measure at 0%).|2 days postoperatively|One participant declined assessment due to soreness in the shoulder muscle.||percent||Inter-Quartile Range|Median
681144|NCT01560988|Secondary|Measure of EPA in Cell Pellets|Secondary outcome measures include changes in concentrations of omega 3 fatty acids in cell pellets, indicating incorporation of botanical oil metabolites in cell membrane lipids.. This was calculated by the difference between the amount present at the start of each arm and at the end of each arm (i.e., two values were obtained in each arm and used to calculate the difference, and the differences were compared as a delta-delta).|Assessed at 2, 8, 14, and 20 weeks|We analyzed all samples available, including from subjects who did not complete the entire protocol (i.e., 40 subjects crossed over and completed both arms, but 44 completed the corn oil and 44 completed the borage and echium arm, and the overlap was incomplete). Thus, the number of subjects differs from the total number of subjects per arm||ng||Standard Deviation|Mean
681145|NCT01560988|Secondary|Asthma Control|Changes in asthma control will be assessed via the Asthma Control Questionnaire (ACQ) at each visit. The ACQ is a 6-point questionnaire that reflects the degree of asthma activity. Each point is assigned a scale of 0-5, with 5 being the worst. Thus, the range is from 0 (no asthma symptoms) to 30 (severe asthma symptoms). For each arm, we generate two values (week 2 vs. week 8 and week 14 vs.week 20). These values are then averaged for each arm to obtain the final single value. A negative number implies improved symptoms.|Assessed at 2, 8, 14, and 20 weeks|We analyzed all samples available, including from subjects who did not complete the entire protocol (i.e., 40 subjects crossed over and completed both arms, but 44 completed the corn oil and 44 completed the borage and echium arm, and the overlap was incomplete). Thus, the number of subjects differs from the total number of subjects per arm||Change in ACQ points||Standard Deviation|Mean
681146|NCT01560988|Secondary|Genotyping at LTC4 Synthase Locus|All individuals will be genotyped at the LTC4S locus. At the end of the study, the investigators will use the information to determine whether the individuals with at least one copy of the C variant of LTC4S display higher levels of lung function while on borage/echium than on placebo and whether their levels of LTC4S protein and mRNA expression in CD14+ monocytes and peripheral blood eosinophils are higher than in individuals with two A alleles.|two weeks||10/2017||||
681147|NCT01560988|Secondary|Plasma Level of Gamma Linolenic Acid (GLA)|Changes in plasma level of gamma linolenic acid (GLA), a major constituent of Borage oil, as a measure of compliance. This was calculated by the difference between the amount produced at the start of each arm and at the end of each arm (i.e., two values were obtained in each arm and used to calculate the difference, and the differences were compared as a delta-delta).|Measurements obtained at 2, 8, 14, and 20 weeks|We analyzed all samples available, including from subjects who did not complete the entire protocol (i.e., 40 subjects crossed over and completed both arms, but 44 completed the corn oil and 44 completed the borage and echium arm, and the overlap was incomplete). Thus, the number of subjects differs from the total number of subjects per arm||ng||Standard Deviation|Mean
681148|NCT01560988|Secondary|Lung Function|Changes in lung function (forced expiratory volume in 1 second) will be assessed via spirometry at each visit. This was calculated by the difference between the FEV1 at weeks 2 and 8 versus weeks 14 and 20. The differences were compared as a delta-delta. A negative number for this parameter means that the FEV1 was lower at the end of the arm than at the beginning, while a positive number means that the FEV1 was higher at the end.|Assessed at 2, 8, 14, and 20 weeks|We analyzed all samples available, including from subjects who did not complete the entire protocol (i.e., 40 subjects crossed over and completed both arms, but 44 completed the corn oil and 44 completed the borage and echium arm, and the overlap was incomplete). Thus, the number of subjects differs from the total number of subjects per arm||Percent change||Standard Deviation|Mean
681149|NCT01560988|Secondary|Measure of DHA in Cell Pellets|Secondary outcome measures include changes in concentrations of omega 3 fatty acids in cell pellets, indicating incorporation of botanical oil metabolites in cell membrane lipids.. This was calculated by the difference between the amount present at the start of each arm and at the end of each arm (i.e., two values were obtained in each arm and used to calculate the difference, and the differences were compared as a delta-delta).|Assessed at 2, 8, 14, and 20 weeks|We analyzed all samples available, including from subjects who did not complete the entire protocol (i.e., 40 subjects crossed over and completed both arms, but 44 completed the corn oil and 44 completed the borage and echium arm, and the overlap was incomplete). Thus, the number of subjects differs from the total number of subjects per arm||ng||Standard Deviation|Mean
681150|NCT01560988|Primary|Change in LTB4 Production|Primary outcome measures will be changes in the generation of LTB4 production by granulocytes. This was calculated by the difference between the amount produced at the start of each arm and at the end of each arm (i.e., two values were obtained in each arm and used to calculate the difference, and the differences were compared as a delta-delta). A negative number implies that the level of LTB4 produced by granulocytes at the end of the arm was less than the amount produced at the start of the arm, while a positive number means that more was generated at the end than at the beginning.|At 2, 8, 14, and 20 weeks|We analyzed all samples available, including from subjects who did not complete the entire protocol (i.e., 40 subjects crossed over and completed both arms, but 44 completed the corn oil and 44 completed the borage and echium arm, and the overlap was incomplete). Thus, the number of subjects differs from the total number of subjects per arm||ng||Standard Deviation|Mean
681151|NCT01560988|Primary|Cellular Changes That Occur With Borage and Echium Seed Oil Supplementation|Primary outcome measures will be changes in the generation of LTC4 production by granulocytes. This was calculated by the difference between the amount produced at the start of each arm and at the end of each arm (i.e., two values were obtained in each arm and used to calculate the difference, and the differences were compared as a delta-delta).|Assessed at 2, 8, 14, and 20 weeks|We analyzed all samples available, including from subjects who did not complete the entire protocol (i.e., 40 subjects crossed over and completed both arms, but 44 completed the corn oil and 44 completed the borage and echium arm, and the overlap was incomplete). Thus, the number of subjects differs from the total number of subjects per arm.||ng||Standard Deviation|Mean
681152|NCT01560975|Secondary|Effect After CPAP Removal on the IOP Pattern|IOP pattern immediately after CPAP removal upon waking in patients with or without POAG|30 min|||mvEq||Standard Deviation|Mean
681153|NCT01560975|Secondary|Relationship Between the 24-hour IOP Fluctuation Patterns and Physiologic Parameters|"Heart rate and ocular pulsation rate during sleep:
using CPAP in patients with or without POAG
not using CPAP in patients with or without POAG"|24-hours|||Correlation||Standard Deviation|Mean
681155|NCT01560819|Primary|Clinical Response|Clinical response (i.e. improvement in Pediatric Ulcerative Colitis Activity Index (PUCAI) score by greater than or equal to 15 points from baseline) at 4 weeks following GMT treatment|4 weeks following GMT Treatment|One participant showed intolerance to the treatment (immediate leaking of enema) and was not included in post-treatment disease activity evaluation.||Participants|||Number
681156|NCT01560507|Secondary|Quit Success Genotype Score|Study was terminated early due to difficulties with enrollment. No outcome measures were assessed.”|After 6 month Follow-Up|Study was terminated early due to difficulties with enrollment. No outcome measures were assessed.|||||
681157|NCT01560507|Primary|Cost-effectiveness of the Adaptive Treatment Approach to Smoking Cessation|Study was terminated early due to difficulties with enrollment. No outcome measures were assessed.|End of study drug treatment period (11-12 weeks)||||||
681158|NCT01560429|Primary|Anesthetic Consumption (mg)|amount of anesthetic consumed was calculated for each group over time.|4,8,12, 24 and 48 hours postoperatively|||mg||Standard Error|Mean
681159|NCT01560429|Secondary|Worst Pain While Coughing|Worst pain on a numerical rating scale(0-10 worst) at 24 and 48 hours following thoracotomy|48 hours postoperatively||||||
681160|NCT01560429|Secondary|Worst Pain Scores|worst pain scores on numerical rating scale (0-10, where 10 is the worst) at 24 & 48 hours following surgery|48 hours postoperatively||||||
681161|NCT01560429|Primary|Local Anesthetic Consumption|Amount of anesthetic consumed (either through epidural catheter or as rescue bolus at 48 hours following thoracotomy administered either through CEA or PCEA.|48 hours postoperatively|||ug||Standard Error|Mean
681162|NCT01560403|Primary|Summary of Treatment-emergent Adverse Events|As the primary intent of this study was to collect additional safety data, this outcomes measure will provide a summary of the treatment emergent adverse events. Based on the start date of each subject in this study and the study end date, not all subjects reached 12 months.|12 months|Safety Population||participants|||Number
681163|NCT01560260|Secondary|Time to Progression|Evaluated using cumulative incidence.|Up to 2 years||||||
681164|NCT01560260|Secondary|Response Duration|Analyzed using Kaplan-Meier curves for the all treated and per protocol populations.|Up to 37 weeks||||||
681165|NCT01560260|Secondary|PFS|Analyzed using Kaplan-Meier curves for the all treated and per protocol populations.|Time from date of enrollment to time of progression or death due to any cause, assessed up to 37 weeks||||||
681166|NCT01560260|Secondary|OS|Analyzed using Kaplan-Meier curves for the all treated and per protocol populations.|Up to 37 weeks||||||
681167|NCT01560260|Secondary|Failure-free Survival|Analyzed using Kaplan-Meier curves for the all treated and per protocol populations.|Up to 37 weeks||||||
681168|NCT01560260|Secondary|Clinical Benefit Rate Defined as SD >= 9 Months, PR or CR||Up to 2 years||||||
681169|NCT01560260|Primary|Response Rate (CR or PR) Using Response Evaluation Criteria in Solid Tumors Guideline Version 1.1||At 6 months|Thirteen patients were still receiving linsitinib at 6 months.||participants|||Number
681170|NCT01560234|Secondary|Statistical Assessment of CXCL10 Ratio-to-baseline- Sputum|Summarize the statistical assessment comparing active CXCL10 ratio to baseline to placebo at each dose level, sampling time, and matrix|Baseline, 24 Hours.|Pharmacodynamic Population Set||ratio||95% Confidence Interval|Least Squares Mean
681171|NCT01560234|Primary|Summary for Lymphocytes Laboratory Results||Baseline, Day 1, Day 2, Day 3, and Follow up (up to Day 13)|Safety Analysis Set||cells*10^9/L||Standard Deviation|Mean
681172|NCT01560234|Secondary|Statistical Assessment of CXCL10 Ratio-to-baseline - Plasma|Smmarize the statistical assessment comparing active CXCL10 ratio to baseline to placebo at each dose level, sampling time, and matrix|Baseline, 48 Hours|Pharmacodynamic Population Set||ratio||95% Confidence Interval|Least Squares Mean
681173|NCT01560234|Secondary|Statistical Assessment of CXCL10 Ratio-to-baseline - Plasma|Smmarizes the statistical assessment comparing active CXCL10 ratio to baseline to placebo at each dose level, sampling time, and matrix|Baseline, 24 Hours.|Pharmacodynamic Population Set||ratio||95% Confidence Interval|Least Squares Mean
681174|NCT01560234|Secondary|Summary (Geometric Mean and GCV%) of Pharmacokinetic Parameters of Total AZ12432045 - Cmax (Nmol/L)||On Day 1 at 0min, 2min, 5min, 10min, 20min, 30min, 45min, 60min, 90min, 2h, 4h, 6h, 8h, 12h, 24h and 48h|Pharmacokinetic Population||nmol/L||Geometric Coefficient of Variation|Geometric Mean
681175|NCT01560234|Secondary|Summary (Geometric Mean and GCV%) of Pharmacokinetic Parameters of Total AZ12432045 - AUC(0-t) (Nmol*h/L)||On Day 1 at 0min, 2min, 5min, 10min, 20min, 30min, 45min, 60min, 90min, 2h, 4h, 6h, 8h, 12h, 24h and 48h|Pharmacokinetic Population||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
681176|NCT01560234|Secondary|Summary (Geometric Mean and GCV%) of Pharmacokinetic Parameters of Total AZ12432045 - AUC (Nmol*h/L)||On Day 1 at 0min, 2min, 5min, 10min, 20min, 30min, 45min, 60min, 90min, 2h, 4h, 6h, 8h, 12h, 24h and 48h|Pharmacokinetic Population||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
681177|NCT01560234|Primary|Adverse Events|Summary of number of subjects who had at least one adverse event|Screening up to Day 13|Safety Analysis Set||participants|||Number
681178|NCT01560143|Primary|Single-dose Serum AUC of Tigecycline Between Time 0 and 96 Hours|The AUC is the area under the concentration time curve in serum measured in the unit of concentration in milligram of tigeycline per liter of plasma multiplied by the time interval in hours (hour*mg/L)|4 days (96 hours)|||hour*mg/L||Standard Deviation|Mean
681179|NCT01559935|Secondary|Stem Cells Collection|At the end of the Car Phase, all participants underwent stem cell collection.|At the end of the Car Phase, prior to the start of the BiRD Phase, on average after 162 days.|58 participants reached the end of the Car Phase. From those 58 participants, 52 were collected, 5 participants declined stem cell collection and 1 participant's results were not evaluable.||Number of stem cells collected per Kg||Standard Deviation|Mean
681180|NCT01559935|Secondary|Progression Free Survival|Progression was defined using the IMWG criteria.|From start of study drug until first incidence of progression, up to 1222 days.|21 participants had an incidence of progression.||months||Full Range|Median
681181|NCT01559935|Secondary|MRD Negativity Following CarBiRD Regimen|"Minimal Residual Disease (MRD) was assessed for all participants as soon as they achieved CR/sCR, regardless of what phase they were on.
MRD negativity is defined as the complete absence of plasma cells on bone marrow biopsy.
MRD positivity is defined as the presence of residual plasma cells (<5%) on bone marrow biopsy.
The IMWG criteria were used to determine CR and sCR."|From start of study up to Revlimid Maintenance Cycle 4.|28 participants achieved CR or sCR.||Participants|||Count of Participants
681182|NCT01559935|Secondary|Event Free Survival|an event is defined by coming off protocol for any reason, including progression of disease, lack of disease response, regimen intolerability, withdrawal of consent or death.|From date of study enrollment until the date of removal of study due to progression of disease, toxicity or withdrawal of consent, up to 1222 days.|44 participants analyzed out of the 72 participants initially enrolled in the study. 28 participants are active and therefore have not experienced any events leading to removal from study.||Days||Full Range|Median
681183|NCT01559935|Primary|Response to Car-BiRD Treatment.|"The best response for all patients who had at least one dose of drug was measured.
Response categories:
Stringent Complete Response (sCR), Complete Remission(CR), Very Good Partial Remission(VGPR), Partial Remission (PR), Progressive Disease (PD), Stable Disease (SD).
The response is evaluated based on the IMWG criteria."|From baseline to best response, up to 116 weeks.|||Participants|||Count of Participants
681184|NCT01559922|Primary|ASRS Responder Rate at 6 Months|"Subject considered to be a responder if at least 50% of treated scars demonstrate an ASRS improvement of ≥ 2-point (Blinded Evaluator assessment)."|6 months post-treatment|Full Analysis Population included only subjects that passed screening||percentage of participants||95% Confidence Interval|Number
681185|NCT01559857|Secondary|Change in HDRS-21: From Baseline to 12 Weeks|The HDRS-21 was administered at baseline and at the end of 12 weeks, and the mean difference between the two time points was calculated. The HDRS-21 is scored on a scale from 0 to 21, where 0 is the lowest level of depression severity and 21 is the highest level of depression severity.|12 weeks|||units on a scale||Standard Deviation|Mean
681186|NCT01559857|Secondary|Fasting Insulin Measurements at Baseline|The fasting plasma insulin measurements taken at baseline are shown in the data table below.|Baseline|||uIU/mL||Standard Deviation|Mean
681187|NCT01559857|Primary|Hamilton Depression Rating Scale at Baseline|The HDRS-21 was used to screen for unremitted depression. The HDRS-21 is scored on a scale from 0 to 21, where 0 is the lowest level of depression severity and 21 is the highest level of depression severity. Unremitted depression is characterized by a score of ≥7. The HDRS-21 scores at baseline are shown in the data table below.|Baseline|||units on a scale||Standard Deviation|Mean
681188|NCT01559844|Primary|Number of Participants Who Died|"Treatment-emergent deaths were those that occurred while taking study drug or to the minimum of 1) date of transplantation, 2) retreatment 1st dose date, or 3) last dose date + 30 days.
Only those participants who underwent liver transplantation were analyzed for death post-transplantation."|Up to 48 weeks following transplant|Safety Analysis Set||participants|||Number
681189|NCT01559844|Secondary|Proportion of Participants With Virologic Failure Prior to Transplant|"Virologic failure (VF) in the pretransplant phase was defined by:
Breakthrough (HCV RNA ≥ 25 IU/ml after having previously had HCV RNA < 25 IU/ml, while on treatment)
Rebound (breakthrough or > 1 log10 IU/ml increase in HCV RNA from nadir while on treatment)
Non-response (HCV RNA ≥ 25 IU/ml through 8 weeks of treatment)
Pre-transplant relapse (HCV RNA ≥ 25 IU/ml during the Pre-Transplant off-treatment follow-up period after having achieved HCV RNA < 25 IU/ml at last observed HCV RNA on treatment)"|Up to 48 weeks prior to transplant|On-treatment VF: Full Analysis Set. Posttreatment/Pretransplant VF - 24 Weeks or 48 Weeks: Participants who completed 24 or 48 weeks of treatment and had an observed or imputed Week 4 posttreatment follow-up HCV RNA value relapsed during posttreatment follow-up were analyzed.||percentage of participants|||Number
681190|NCT01559844|Secondary|HCV RNA and Change From Baseline in HCV RNA Through Week 8||Up to 8 weeks prior to transplant|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
681191|NCT01559844|Secondary|Percentage of Participants With HCV RNA < LLOQ (ie, 25 mL/IU) During Treatment Through Week 48||Up to 48 weeks prior to transplant|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants|||Number
681192|NCT01559844|Secondary|Percentage of Participants With Posttransplant Virologic Response (pTVR) Through Posttransplant Week 48|pTVR was defined as HCV RNA < the lower limit of quantification (LLOQ, ie, 25 mL/IU) at the relevant time point after transplant.|Up to 48 weeks following transplant|Participants in the Full Analysis Set who underwent liver transplantation and who had ≥ 12 weeks treatment and HCV RNA < LLOQ at last measurement prior to transplant were analyzed.||percentage of participants|||Number
681193|NCT01559844|Primary|Percentage of Participants With Graft Loss Following Transplant||Up to 48 weeks following transplant|Participants in the Safety Analysis Set who underwent liver transplantation were analyzed.||percentage of participants|||Number
681194|NCT01559844|Primary|Percentage of Participants Experiencing Any Adverse Event Leading to Permanent Discontinuation of Sofosbuvir Prior to Receiving Transplant||Up to 48 weeks prior to transplant|Safety Analysis Set||percentage of participants|||Number
681195|NCT01559844|Primary|Percentage of Participants With Posttransplant Virologic Response (pTVR) at Posttransplant Week 12|pTVR was defined as HCV RNA < the lower limit of quantification (LLOQ, ie, 25 mL/IU) at Week 12 after transplant.|Posttransplant Week 12|Participants in the Full Analysis Set (enrolled and received at least 1 dose of study drug) who underwent liver transplantation, and who had HCV RNA < LLOQ at last measurement prior to transplant were analyzed.||percentage of participants|||Number
681196|NCT01559675|Secondary|Postoperative Pain|Assessed daily by visual analog pain score (0 to 10; no pain to severe)|Postoperative day 1 - 7||||||
681197|NCT01559675|Secondary|Hemodynamic Instability|Hemodynamic instability defined by heart rate >100 bpm, <60 bpm, Systolic blood pressure <90 mm Hg|From time of surgical incision to Postoperative day 7||||||
681198|NCT01559675|Secondary|Length of Postoperative Hospitalization (Days)||Duration of hospital stay (expected average of 5 days)||||||
681199|NCT01559675|Secondary|Minor and Major Medical and Surgical Complications||Through Postoperative day 30||||||
681200|NCT01559675|Secondary|Postoperative Fatigue|Measured daily, score 0 (no fatigue) to 10 (very fatigued)|Postoperative day 1 - 7||||||
681201|NCT01559675|Secondary|Postoperative Nausea|Measured daily Postoperative day 1 - 7 on a scale from 0 (no nausea) to 10 (nausea as bad as can be)|Postoperative day 1 - 7||||||
681202|NCT01559675|Secondary|Hemodynamic Instability||Through the end of hospitalization or 7 days postoperatively||||||
681203|NCT01559675|Primary|Orthostatic Hypotension||Postoperative Day 1|||participants|||Number
682598|NCT01539525|Primary|Days Per Month of Primary Substance Use|Participants completed a timeline followback at each assessment, reporting days of primary substance use. Outcomes reported are raw means and standard deviations.|7 non-overlapping monthly intervals from baseline to month 6|||days per month||Standard Deviation|Mean
681204|NCT01559649|Secondary|Reliability of Nurse Interpretation of Each Screening Items and the Valid Combination of Items|Determine if stroke-ward staff nurses can make reliable inter-rater judgments of swallowing (e.g. cough after swallow, wet voice after swallow) and nonswallowing features (e.g. decreased volitional cough, dysarthria) historically used by SLPs to make judgments of aspiration.|3 years|||kappa||95% Confidence Interval|Number
681205|NCT01559649|Secondary|Average Accuracy Rate for Nurse Administration for All Screening Procedures|Determine if current stroke-ward staff nurses can accurately administer screening items.|3 years|||percentage of accuracy||Full Range|Mean
681206|NCT01559649|Primary|Negative Predictive Value of Screening Items|Identify the combination of screenings items that provide the highest level of negative predictive value in the identification of aspiration risk as measured by a videofluoroscopic swallow study (VFSS) in individuals admitted with suspected stroke.|3 years|Nurses were not assessed for this outcome measure||percentage of agreement||95% Confidence Interval|Number
681207|NCT01559649|Primary|Specificity of Screening Items|Identify the combination of screenings items that provide the highest level of specificity in the identification of aspiration risk as measured by a videofluoroscopic swallow study (VFSS) in individuals admitted with suspected stroke.|3 years|Nurses were not assessed for this outcome measure||percentage of agreement||95% Confidence Interval|Number
681208|NCT01559649|Primary|Sensitivity of Screening Items|Identify the combination of screenings items that provide the highest level of sensitivity in the identification of aspiration risk as measured by a videofluoroscopic swallow study (VFSS) in individuals admitted with suspected stroke.|3 years|Nurses were not assessed for this outcome measure||percentage of agreement||95% Confidence Interval|Number
681209|NCT01559506|Primary|CFU Density|Colony-forming unit density at incision site (CFU/m3)|Surgical case CFU density will be determined at up to 1 month from completion of surgical cases|||CFU/m^3||95% Confidence Interval|Mean
681210|NCT01559454|Secondary|Treatment Retention|Number of participants that completed the study protocol|6 months|||participants|||Number
681211|NCT01559454|Secondary|Depression|"Depression will be assessed using the Beck Depression Inventory, a 63 point scale with 0 being none and 63 being severe."|at 6 months|||units on a BDI scale||Standard Deviation|Mean
681212|NCT01559454|Secondary|Functioning|"Functioning will be assessed using the Visual Analogue Scale (VAS) with 0 being no limits and 100 being bedridden."|at 6 months|||units on a VAS scale||Standard Deviation|Mean
681213|NCT01559454|Secondary|Cravings|Cravings will be assessed using the Visual Analogue Scale (VAS) with 0 being no cravings and 100 being worse possible cravings|at 6 months|||units on a VAS scale||Standard Deviation|Mean
681214|NCT01559454|Secondary|Illicit Drug Use|Illicit opioid use will be measured by self-report and confirmed with urine toxicology.|6 months|19 participants were enrolled in the study, and 10 were available at the 6-month follow-up||participants|||Number
681215|NCT01559454|Primary|Analgesia|Pain severity will be measured using the Visual Analogue Scale (VAS) which has a range of 0-100 with 0 being no pain and 100 being worse possible pain.|6 months|19 participants were enrolled in the study, and 10 were available for the 6-month follow-up.||units on a VAS scale||Standard Deviation|Mean
681216|NCT01559311|Primary|LVESV|Left ventricular end-systolic volume (LVESV) for assessment of LV remodeling|12 months|From Feb 2013 to Dec 2014, only 98 subjects out of 177 target enrolments were recruited into the study.||ml||Standard Deviation|Mean
681217|NCT01559311|Primary|LVEF|Left Ventricular Ejection Fraction (LVEF) for assessment of Left ventricular (LV) systolic function|12 months|From Feb 2013 to Dec 2014, only 98 subjects out of 177 target enrolments were recruited into the study.||% LVEF||Standard Deviation|Mean
681218|NCT01559116|Secondary|Peak (0-3h) FVC Response [L] After 6 Weeks Treatment.|"Peak (0-3h) Forced Vital Capacity (FVC) responses after 6 weeks treatment.
Peak was defined as the maximum value measured within the first 3 h post dosing and response was defined as the change from patient baseline.
Mean is actually the Adjusted mean.
The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within−patient variation and Kenward−Roger approximation of denominator degrees of freedom."|day 1 and week 6|Full Analysis Set (FAS)||Litres (L)||Standard Error|Mean
681219|NCT01559116|Secondary|Trough FVC Response [L] After 6 Weeks Treatment.|"Trough Forced Vital Capacity (FVC) response after 6 weeks treatment period.
The trough was defined as the mean of the 23 h and 23 h50 min measurements and response was defined as the change from patient baseline.
Mean is actually the Adjusted mean.
The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within−patient variation and Kenward−Roger approximation of denominator degrees of freedom."|day1 and week 6|Full Analysis Set (FAS).||Litres (L)||Standard Error|Mean
681220|NCT01559116|Secondary|FVC AUC12-24h Response [L] After 6 Weeks Treatment.|"Area under the Forced Vital Capacity (FVC) after 6 weeks treatment period-time curve from 12 to 24 h post-dose using the trapezoidal rule, divided by the duration (12 h) to report in litres.
Mean is actually the Adjusted mean.
The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within−patient variation and Kenward−Roger approximation of denominator degrees of freedom."|day 1 and week 6|Full Analysis Set (FAS).||Litres (L)||Standard Error|Mean
681221|NCT01559116|Secondary|FVC AUC0-12h Response [L] After 6 Weeks Treatment.|"Area under the Forced Vital Capacity (FVC) after 6 weeks treatment period-time curve from 0 to 12 h post-dose using the trapezoidal rule, divided by the duration (12 h) to report in litres.
Mean is actually the Adjusted mean.
The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within−patient variation and Kenward−Roger approximation of denominator degrees of freedom."|day 1 and week 6|Full Analysis Set (FAS)||Litres (L)||Standard Error|Mean
681273|NCT01558297|Primary|Body Weight in Pounds.|Body weight lost in pounds measured 3 months after first treatment session.|3 months after treatment start (Baseline)|Intent-to-treat data are presented, with the last observation carried forward, and outliers beyond 3 standard deviations replaced with highest recorded value within the 3 standard deviation range.||pounds||Standard Deviation|Mean
681222|NCT01559116|Secondary|FVC AUC0-24h Response [L] After 6 Weeks Treatment.|"Area under the Forced Vital Capacity (FVC) after 6 weeks treatment period-time curve from 0 to 24 h post-dose using the trapezoidal rule, divided by the duration (24 h) to report in litres.
Mean is actually the Adjusted mean.
The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within−patient variation and Kenward−Roger approximation of denominator degrees of freedom."|day 1 and week 6|Full Analysis Set (FAS).||Litres(L)||Standard Error|Mean
681223|NCT01559116|Secondary|Peak(0-3h) FEV1 Response [L] After 6 Weeks Treatment.|"Peak (0-3h) Forced Expiratory Volume in 1 second (FEV1) response.
The peak was defined as the maximum value measured within the first 3 h post dosing and response was defined as the change from patient baseline.
Mean is actually the Adjusted mean.
The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within−patient variation and Kenward−Roger approximation of denominator degrees of freedom."|day 1 and week 6|Full Analysis Set (FAS).||Litres (L)||Standard Error|Mean
681224|NCT01559116|Secondary|Trough FEV1 Response [L] After 6 Weeks Treatment.|"Trough Forced Expiratory Volume in 1 second (FEV1) response after 6 weeks treatment period.
The trough was defined as the mean of the 23 h and 23 h50 min measurements and Response was defined as the change from patient baseline.
Mean is actually the Adjusted mean.
The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within−patient variation and Kenward−Roger approximation of denominator degrees of freedom."|day 1 and week 6|Full Analysis Set (FAS)||Litres||Standard Error|Mean
681225|NCT01559116|Secondary|FEV1 AUC12-24h Response [L] After 6 Weeks Treatment.|"Area under the Forced Expiratory Volume in 1 second (FEV1) after 6 weeks treatement-time curve from 12 to 24 h post-dose using the trapezoidal rule, divided by the duration (12 h) to report in litres.
Mean is actually the Adjusted mean.
The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within−patient variation and Kenward−Roger approximation of denominator degrees of freedom."|day 1 and week 6|Full Analysis Set (FAS).||Litres (L)||Standard Error|Mean
681226|NCT01559116|Secondary|FEV1 AUC0-12h Response [L] After 6 Weeks Treatment.|"Area under the Forced Expiratory Volume in 1 second (FEV1) after 6 weeks treatement-time curve from 0 to 12 h post-dose, using the trapezoidal rule, divided by the duration (12h) to report in litres.
Mean is actually the Adjusted mean.
The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within−patient variation and Kenward−Roger approximation of denominator degrees of freedom."|day 1 and week 6|Full Analysis Set (FAS).||Litres (L)||Standard Error|Mean
681227|NCT01559116|Primary|Forced Expiratory Volume in 1 Second (FEV1) AUC0-24h Response [L] After 6 Weeks Treatment.|"Area under the Forced Expiratory Volume in 1 second (FEV1) after 6 weeks treatement-time curve from 0 to 24 h post-dose, using the trapezoidal rule, divided by the duration (24 h) to report in litres.
Mean is actually the Adjusted mean.
The adjusted mean and standard error (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within−patient variation and Kenward−Roger approximation of denominator degrees of freedom."|day 1 and week 6|Full Analysis Set (FAS): This patient set included patients in the Treated Set (TS) who had any period baseline and any evaluable post-dose data for the primary efficacy endpoint at any Week 6 visits.||Litres (L)||Standard Error|Mean
681228|NCT01559064|Primary|Subject Experience Measured by Patient Satisfaction Questionnaire|Subject satisfaction with treatment, based on a 5-point scale: (1) Delighted, (2) Happy, (3) Neutral, (4) Unhappy, (5) Very Unhappy|3 weeks|||Units on a scale||Standard Deviation|Mean
681229|NCT01559012|Secondary|Diastolic Blood Pressure|Diastolic BP was recorded every day during clonidine (5 days) and placebo (5 days) cycle|10 days|||mmHg||95% Confidence Interval|Mean
681230|NCT01559012|Secondary|Systolic Blood Pressure|Systolic BP was measured every day during the clonidine treatment (5 days) and placebo (5 days)|10 days|||mmHg||95% Confidence Interval|Mean
681231|NCT01559012|Secondary|Newborn Outcome Measure: APGAR Score.|"The APGAR score is the most common indicator of neonatal status immediately after delivery.
The test is done by a doctor, midwife, or nurse. The health care provider will examine the baby's:
Breathing effort Heart rate Muscle tone Reflexes Skin color Each category is scored with 0, 1, or 2, depending on the observed condition. The APGAR rating is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth."|at 1 minute and at 5 minutes after delivery|APGAR score of newborns at 1 minute and at 5 minutes||units on a scale||Full Range|Mean
681232|NCT01559012|Secondary|Pregnancy Outcome Measures: Birth Weight.|Birth weight adjusted for gestational age at delivery is a measure of pregnancy outcome after treatment of HG.|at delivery|no determination of sample size Recording for safety issue||grams||Full Range|Mean
681233|NCT01559012|Secondary|Number of Patients Choosing Active Treatment for Off-label, Compassionate Use.|the patients were asked to choose between two transdermal systems (active drug versus placebo) as the most effective|at 10 days since start of treatment|no determination of sample size||participants|||Number
681234|NCT01559012|Secondary|Number of Days Off i.v. Therapy, the TD System (Clonidine/Placebo) Being Applied Only|if the symptoms improve the patient and her doctors may decide to stop parenteral drugs continuing the TD system therapy.|participants are followed for the whole duration of hospital stay (10 days) comparing the first period of 5 days with the second period of 5 days|||Proportion of person-days||95% Confidence Interval|Mean
681274|NCT01558297|Primary|Body Weight in Pounds.|Body weight lost in pounds measured 1.5 months after first treatment session.|1.5 months after treatment start (Baseline)|Intent-to-treat data are presented, with the last observation carried forward, and outliers beyond 3 standard deviations replaced with highest recorded value within the 3 standard deviation range.||pounds||Standard Deviation|Mean
681235|NCT01559012|Secondary|Daily Doses of Standard Antiemetic Drugs Required in the Two Different Periods.|"The patients were randomly treated with and without TD clonidine (5mg patch) for 2 consecutive periods of 5 days , other antiemetic drugs (promethazine, prochlorperazine, metoclopramide, ondansetron) and anti reflux drugs (ranitidine, omeprazole) being administered on a scheduled or as-needed basis.
All patients received intravenous hydration and supplementation with thiamine, during both periods. The use of steroids was allowed as a rescue medication in case of further worsening of symptoms."|participants are followed for the whole duration of hospital stay (10 days) comparing the first period of 5 days with the second period of 5 days|||daily doses of antiemetics||95% Confidence Interval|Mean
681236|NCT01559012|Secondary|Morning Urine Ketonuria|Morning urine ketonuria is a simple direct marker of starving associated to nausea and vomiting|participants are followed for the whole duration of hospital stay (10 days) comparing the first period of 5 days with the second period of 5 days|||Proportion of person-days||95% Confidence Interval|Mean
681237|NCT01559012|Primary|VAS Score for Assessment of Severity in Hyperemesis Gravidarum|VAS is a Visual Analogic Scale formulated in 5 items. Every item has a score from 0 (best) to 10 (worst). The sum range swings from 0 (best ) to 50 (worst). Participants are followed for the whole duration of hospital stay (10 days) asking them to score their symptoms daily.|Mean values of first period of five days are compared with mean values of second period of five days. Change is reported as baseline value - value at day 5 or at day 10.|||units on a scale||95% Confidence Interval|Mean
681238|NCT01559012|Primary|PUQE Score for Assessment of Severity in Hyperemesis Gravidarum|"PUQE in an acronym for Pregnancy Unique Quantification of Emesis, a validated clinical score for assessment of severity of emesis in pregnancy.
It is composed of three items; every item has a score from 1 (best) to 5 (worst).
The sum range varies from 3 (best) to 15 (worst). Participants are followed for the whole duration of hospital stay (10 days) asking them to score their symptoms daily."|Mean values of first period of five days are compared with mean values of second period of five days. Change is reported as baseline value - value at day 5 or at day 10.|A sample size calculation for crossover studies using a model available on line (MGH Mallinckrodt General Clinical Research Center - Harvard Medical School) showed that a total of 12 patients were needed in order to detect a difference of 2 points of PUQE score between the two groups at P < 0.01 and a beta > 0.90.||units on a scale||95% Confidence Interval|Mean
681239|NCT01558791|Primary|Illness Perception - Duration of Symptoms|Participants rate on a Likert Scale from 0-10 how long they think their current symptoms will continue with 0 being a very short time and 10 being forever.|One day- Participants complete a questionnaire within 1 day of TBI screening. There is no follow up assessment.|All veterans screened who accepted questionnaire||units on a scale||Standard Deviation|Mean
681240|NCT01558791|Primary|Illness Perception - Current Symptoms|Participants rate on a Likert Scale from 0-10 how much their current symptoms affect their life, with 0 being no affect, and 10 being severe.|One day- Participants complete a questionnaire within 1 day of TBI screening. There is no follow up assessment.|All veterans who accepted questionnaire||units on a scale||Standard Deviation|Mean
681241|NCT01558791|Secondary|Feasibility Questionnaire|A brief feasibility questionnaire will be used to evaluate provider feedback regarding administering the educational handout as part of the TBI clinical reminder.|One month- Providers complete a questionnaire within 1 month after data collection ends for the site.||||||
681242|NCT01558791|Primary|mTBI Questionnaire|The primary outcome is knowledge gained about mTBI and illness perception. This is evaluated by number correct out of 10 true or false questions.|One day- Participants complete a questionnaire within 1 day of TBI screening. There is no follow up assessment.|All veterans screened who accepted the questionnaire.||correct answers out of 10||Standard Deviation|Mean
681243|NCT01558739|Secondary|Percentage of Participants With Transfusion Dependency Status|Transfusion dependency status from baseline through the end of study was assessed. New onset of transfusion dependency was defined as the use of 2 or more units of red blood cell products during the 8 weeks prior to a study visit. New onset of transfusion independency was defined as the use of 0 or 1 unit of red blood cell products during the 8 weeks prior to a study visit.|baseline (BL), end of treatment (up to 28 days post last treatment) (EOT)|Full analysis set (FAS): The FAS included all participants who received at least one administration of study drug and had at least one post-baseline efficacy assessment.||Percentage of participants|||Number
681244|NCT01558739|Secondary|Number of General Practitioner (GP), Specialists' and Urgent Care Visits|MRU was assessed according to the number of GP, specialists', and urgent care visits.|baseline to week 12, week 12 to, week 24, week 24 to week 36, week 36 to week 48|Only participants from the full analysis set (FAS), who had evaluable measurements at each timeframe, e.g. from baseline to week 12, were included in the analysis for that timeframe. The FAS included all participants who received at least one administration of study drug and had at least one post-baseline efficacy assessment.||number of visits||Full Range|Median
681245|NCT01558739|Secondary|Number of Accident & Emergency Visits From Baseline|MRU was assessed according to the number of accidents and emergency room visits.|baseline to week 12, week 12 to week 24, week 24 to week 36, week 36 to week 48|Only participants from the full analysis set (FAS), who had evaluable measurements at each timeframe, e.g. from baseline to week 12, were included in the analysis for that timeframe. The FAS included all participants who received at least one administration of study drug and had at least one post-baseline efficacy assessment.||Number of visits||Full Range|Median
681246|NCT01558739|Secondary|Duration of Hospitalizations|MRU was assessed according to the mean duration of hospitalization visits.|week 48|Participants from the full analysis set, who were hospitalized between baseline and week 48, were included in the analysis.||days||Standard Deviation|Mean
681247|NCT01558739|Secondary|Number of Hospitalizations|Medical resource utilization (MRU) was assessed according to the number of hospitalizations.|week 12, week 24, week 26, week 48|Only participants from the full analysis set (FAS), who had evaluable measurements at the post-baseline week time point, were included in the analysis for that time point. The FAS included all participants who received at least one administration of study drug and had at least one post-baseline efficacy assessment.||number of hospitalizations||Standard Deviation|Mean
681319|NCT01557894|Secondary|Beck Depression Inventory-II (BDI-II)|"Beck Depression Inventory-II (BDI-II) is a 21-item self-report inventory widely used to assess DSM-IV depressive symptoms. Each item consists of four statements, scored 0–3, indicating increasing symptom severity.
Thus, for BDI-II the range of scores is 0-63, with higher scores reflecting higher levels of depression."|pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37)|||units on a scale||Standard Deviation|Mean
681248|NCT01558739|Secondary|Change From Baseline in EQ5D Preference Index (5 Level EuroQol Questionnaire Determining Quality of Life) From Baseline|The EQ-5D is a standardized instrument used for measuring health outcomes in a wide range of health conditions and treatment. It consists of a descriptive system and a visual analogue scale (EQ-VAS). The descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The EQ-VAS records the participant's self-rated health on a vertical, VAS where the endpoints are labeled 'best imaginable health state' and 'worst imaginable health state'. The EQ-5D health state was converted to a single summary index by applying a formula that attaches a weight to each of the levels in each dimension. The final EQ5D preference index scores range from 0 to 1 with higher scores indicating better health.|Baseline, week 4, week 12, week 24, week 48|Only participants from the full analysis set (FAS), who had evaluable measurements at both baseline and the post-baseline week time point, was included in the analysis for that time point. The FAS included all participants who received at least one administration of study drug and had at least one post-baseline efficacy assessment.||unit on a scale||Standard Deviation|Mean
681249|NCT01558739|Secondary|Change From Baseline in Myelofibrosis Symptoms Assessment Form (MF-SAF)|The MF-SAF consists of seven questions about key symptoms and impact of MF. Questions are scored on a scale of 0–10, with higher scores indicating more severe symptoms and greater inactivity. Questions 1–6, which together comprise a Total Symptom Score (TSS), investigate the following symptoms: night sweats, pruritus/itching, abdominal discomfort, pain under the ribs, early satiety and bone/muscle pain. Question 7 asks patients to report levels of inactivity. The TSS reflects the sum of the scores of these symptoms excluding inactivity, with the maximum possible score being 60 (most severe symptom experienced).|Baseline, week 4, week 12, week 24, week 48|Only participants from the full analysis set (FAS), who had evaluable measurements at both baseline and the post-baseline week time point, was included in the analysis for that time point. The FAS included all participants who received at least one administration of study drug and had at least one post-baseline efficacy assessment.||score on a scale||Standard Deviation|Mean
681250|NCT01558739|Secondary|Percentage of Participants With Best Overall Response|Response to treatment and disease progression was assessed by physical examination, specifically assessing changes in spleen size by palpation. Disease response and progression was evaluated using the International Working Group for myelofibrosis Research and Treatment Response Criteria.|week 48|Full Analysis Set (FAS): The FAS included all participants who received at least one administration of study drug and had at least one post-baseline efficacy assessment.||Percentage of participants|||Number
681251|NCT01558739|Primary|Percentage of Participants With Treatment Success|Treatment success was defined as a 50% or greater reduction in palpable spleen length versus baseline at 48 weeks and/or a 50% or greater improvement in total symptom score (derived from the MF symptom assessment form (MFSAF) questionnaire) versus baseline at the week 48 time point. The MFSAF assesses the following symptoms (all scored from absent (0) to worst imaginable (10)): general fatigue, abdominal pain (and discomfort), inactivity (ability to move and walk around), cough, night sweats, itching (pruritus), bone pain (diffuse not joint pain or arthritis), fever, change in appetite/unintentional weight loss (or gain) in past 6 months, overall quality of life (QoL).|48 Weeks|Full analysis set (FAS): The FAS included all participants who received at least one administration of study drug and had at least one post-baseline efficacy assessment.||Percentage of participants|||Number
681252|NCT01558700|Secondary|Change in Pain Magnitude|The Western Ontario and McMaster Osteoarthritis Index (WOMAC) score change was assess by subtracting WOMAC score after treatment (week 16) to the baseline WOMAC score. WOMAC score has a range from 0 up to 96, higher score meaning worse condition. The outcome is the decrease in WOMAC scores, meaning that the higher is the decrease, the most improvement in the condition.|16 weeks compared to baseline|||Scores on a scale||Standard Deviation|Mean
681253|NCT01558700|Primary|Change in Brain Gray Matter Volume|The change in gray matter volume is evaluated by subtracting the volume after the treatment (week 16) to the volume before treatment (baseline)|16 weeks compared to baseline|||percentage of change||Standard Deviation|Mean
681254|NCT01558674|Secondary|Apparent Terminal Half-life (t1/2) of MK-7145 (Part 2)|Blood samples taken at predose, 0.5, 1, 2, 5, 8, 12, 14 and 24 hours postdose on Days 1 and 14 of Period 2 and Day 14 of Periods 3 and 4 to determine the t1/2.|up to 24 hours post morning dose on Days 1 and 14 of Period 2 and Day 14 of Periods 3 and 4|No participants were enrolled in Part 2 of the study.|||||
681255|NCT01558674|Secondary|Time to Cmax (Tmax) of MK-7145(Part 2)|Blood samples taken at predose, 0.5, 1, 2, 5, 8, 12, 14 and 24 hours postdose on Days 1 and 14 of Period 2 and Day 14 of Periods 3 and 4 to determine the Tmax.|up to 24 hours post morning dose on Days 1 and 14 of Period 2 and Day 14 of Periods 3 and 4|No participants were enrolled in Part 2 of the study.|||||
681256|NCT01558674|Secondary|Trough Plasma Concentration (Ctrough) of MK-7145 (Part 2)|Blood samples taken at predose, 0.5, 1, 2, 5, 8, 12, 14 and 24 hours postdose on Days 1 and 14 of Period 2 and Day 14 of Periods 3 and 4 to determine the Ctrough.|up to 24 hours post morning dose on Days 1 and 14 of Period 2 and Day 14 of Periods 3 and 4|No participants were enrolled in Part 2 of the study.|||||
681257|NCT01558674|Secondary|Maximum Plasma Concentration (Cmax) of MK-7145 (Part 2)|Blood samples taken at predose, 0.5, 1, 2, 5, 8, 12, 14 and 24 hours postdose on Days 1 and 14 of Period 2 and Day 14 of Periods 2-4 to determine the Cmax.|up to 24 hours post morning dose on up to 24 hours post morning dose on Days 1 and 14 of Period 2 and Day 14 of Periods 3 and 4|No participants were enrolled in Part 2 of the study.|||||
681258|NCT01558674|Secondary|Area Under the Concentration-time Curve From Time Zero to 24 Hours After Dosing (AUC0-24hr) of MK-7145 (Part 2)|Blood samples taken at predose, 0.5, 1, 2, 5, 8, 12, 14 and 24 hours postdose on Days 1 and 14 of Period 2 and Day 14 of Periods 3-4 to determine the AUC0-24hr|up to 24 hours post morning dose on Days 1 and 14 of Period 2 and Day 14 of Periods 3 and 4|No participants were enrolled in Part 2 of the study.|||||
681259|NCT01558674|Secondary|Serum Creatinine Measured at 24 Hours Post Last Morning Dose of Each Period (Part 2)|Blood samples were collected at 24 hours post last morning dose of each period to determine serum creatinine levels|Day 15 for Periods 1, 2, and 3; Day 29 for Period 4|No participants were enrolled in Part 2 of the study.|||||
681628|NCT01553318|Primary|Change From Baseline in Weekly Average Pain Score on the Visual Analog Scale at Week 10|Change in weekly average pain score from baseline to week 10 (range from -10 to +10): interpretation= the more negative the value is, the larger reduction in pain severity at week 10 is|baseline and week 10|||units on a scale||Standard Deviation|Mean
681260|NCT01558674|Secondary|Apparent Terminal Half-life (t1/2) of MK-7145 (Part 1)|Blood samples for pharmacokinetic analysis were collected on Treatment Day 1 through Treatment Day 5 at the following time points: Predose, 3, 5, 6, 8, 10, 12, 14, 18, 24, 96, 101, 104, 106, 108, 110 and 120 hours (relative to Treatment Day 1 dosing). The t1/2 was calculated.|Treatment Day 1 and Treatment Day 5|All participants who received at least 1 dose of MK-7145 and who complied with the protocol sufficiently and had data available for endpoint. t1/2 could not be estimated due to insufficient terminal phase sample. Part 1: Period 3 was not conducted.||hours||95% Confidence Interval|Median
681261|NCT01558674|Secondary|Time to Cmax (Tmax) of MK-7145(Treatment Days 1 and 5: Part 1)|Blood samples for pharmacokinetic analysis were collected on Treatment Day 1 through Treatment Day 5 at the following time points: Predose, 3, 5, 6, 8, 10, 12, 14, 18, 24, 96 , 101, 104, 106, 108, 110 and 120 hours (relative to Treatment Day 1 dosing). The time to Cmax (Tmax) calculated for Treatment Days 1 and 5|Treatment Day 1 and Treatment Day 5|All participants who received at least 1 dose of MK-7145 who complied with the protocol sufficiently and had data available for endpoint. Part 1: Period 3 was not conducted.||hours||Full Range|Median
681262|NCT01558674|Secondary|Trough Plasma Concentration (Ctrough) of MK-7145 (Treatment Days 1 and 5: Part 1)|Blood samples for pharmacokinetic analysis were collected on Treatment Day 1 through Treatment Day 5 at the following time points: Predose, 3, 5, 6, 8, 10, 12, 14, 18, 24 , 96 , 101, 104, 106, 108, 110 and 120 hours (relative to Treatment Day 1 dosing). The Ctrough for was calculated for Treatment Days 1 and 5|Treatment Day 1 and Treatment Day 5|All participants who received at least 1 dose of MK-7145, who complied with the protocol sufficiently and had data available for endpoint. Ctrough for MK-7145 8 mg arm could not be estimated due to insufficient terminal phase sample. Part 1: Period 3 was not conducted.||nM||Geometric Coefficient of Variation|Geometric Mean
681263|NCT01558674|Secondary|Maximum Plasma Concentration (Cmax) of MK-7145 (Treatment Days 1 and 5: Part 1)|Blood samples for pharmacokinetic analysis were collected on Treatment Day 1 through Treatment Day 5 at the following time points: Predose, 3, 5, 6, 8, 10, 12, 14, 18, 24, 96, 101, 104, 106, 108, 110 and 120 hours (relative to Treatment Day 1 dosing). The Cmax was calculated for Treatment Days 1 and 5.|Treatment Day 1 and Treatment Day 5|All participants who received at least 1 dose of MK-7145, who complied with the protocol sufficiently and had data available for endpoint. Part 1: Period 3 was not conducted||nM||Geometric Coefficient of Variation|Geometric Mean
681264|NCT01558674|Secondary|Area Under the Concentration-time Curve From Time Zero to 24 Hours After Dosing (AUC0-24hr) of MK-7145 (Treatment Days 1 and 5: Part 1)|Blood samples for pharmacokinetic analysis were collected on Day 4 (Treatment Day 1) through Day 8 (Treatment Day 5) at the following time points: Predose, 3, 5, 6, 8, 10, 12, 14, 18, 24 , 96, 101, 104, 106, 108, 110 and 120 hours (relative to Day 4 dosing). The AUC0-24 was calculated for Days 1 and 5|up to 24 hours post-dose on Treatment Day 1 and Treatment Day 5|All participants who received at least 1 dose of MK-7145, who complied with the protocol sufficiently and had data available for endpoint. Part 1: Period 3 was not conducted||nM*hr||Geometric Coefficient of Variation|Geometric Mean
681265|NCT01558674|Secondary|Fold Change From Baseline for Serum Creatinine at 24-hours Post Treatment Day 5 Morning Dose (Part 1)|Blood was collected predose on Treatment Day 1 and at 24 hours post morning dose on Treatment Day 5 to determine serum creatinine levels. Creatinine levels were log transformed and then fold change from baseline was calculated.|Baseline (predose Treatment Day 1) and 24 hours post morning dose on Treatment Day 5 of each treatment period (Part I)|All participants who received at least 1 dose of study drug , who complied with the protocol sufficiently and had data available for endpoint. Part 1: Period 3 was not conducted.||mg/dL||95% Confidence Interval|Geometric Mean
681266|NCT01558674|Primary|N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) Values at 24 Hours Post Last Morning Dose of Each Period (Part 2)|B-type natriuretic peptide (BNP) is a substance secreted from the ventricles or lower chambers of the heart in response to changes in pressure that occur when heart failure develops and worsens. The level of BNP in the blood increases when heart failure symptoms worsen, and decreases when the heart failure condition is stable. The BNP level in a person with heart failure is higher than in a person with normal heart function. Levels of BNP levels were assessed 24 hours post last morning dose of study drug for each treatment period.|Day 15 for Periods 1, 2, and 3; Day 29 for Period 4|Part 2 of the study was not conducted. No participants were enrolled.|||||
681267|NCT01558674|Primary|Change From Baseline in First 24hr Urinary Sodium (UNa) (Part 1)|Urine was collected at Treatment Day -1 and Treatment Day 1 at 0-2, 2-4, 4-6, 6-8, 8-12, 12-24 hour. The 24-hour cumulative natriuresis will be estimated by the amount of sodium excreted into urine over 24 hour period postdose, where amount of sodium is the product of sodium concentration and the volume of urine. The change from baseline in UNa from baseline (Treatment Day -1) and 24 hours post-dose on Treatment Day 1 were calculated.|Baseline (Day -1) and 0-24 hours postdose on Treatment Day 1 of each treatment period|All participants who received at least 1 dose of study drug and who complied with the protocol sufficiently. One participant did not participate for several time intervals on Period 2: Day 8 due to being unwell, and data from this day of this participant were excluded from the analysis. Part 1: Period 3 was not conducted.||mEq||95% Confidence Interval|Least Squares Mean
681268|NCT01558596|Primary|Troponin I Elevation Above the Upper Reference Limit (URL)|Troponin I is a biomarker of myocardial necrosis that may indicate myocardial damage or injury that occurs during the perioperative period|Within 3 days of the vascular operation|||participants|||Number
681269|NCT01558492|Secondary|Change in Survival Status||6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months and 48 months.|This study was terminated early due to poor accrual. There were no publications as a result. Data were not collected.|||||
681270|NCT01558492|Primary|Change in Tumor Size|Assessed by CT or MRI scan and/or bone scan.|Baseline, week 12, week 24 and end of study.|This study was terminated early due to poor accrual. There were no publications as a result. Data were not collected.|||||
681271|NCT01558492|Primary|Change in Prostate-specific Antigen (PSA) Level||Baseline, week 4, week 8, week 12, week 16, week 20, week 24 and end of study.|This study was terminated early due to poor accrual. There were no publications as a result. Data were not collected.|||||
681272|NCT01558297|Primary|Body Weight in Pounds.|Body weight lost in pounds measured 6 months after first treatment session (3 month follow-up after active treatment ends).|6 months after treatment start (Baseline)|Intent-to-treat data are presented, with the last observation carried forward, and outliers beyond 3 standard deviations replaced with highest recorded value within the 3 standard deviation range.||pounds||Standard Deviation|Mean
681275|NCT01558271|Secondary|Change From Baseline in Electrocardiogram Parameters at 26 Weeks and 52 Weeks|Fridericia Corrected QT (QTcF) Interval and PR Interval are summarized. The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTcF = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. PR is the interval between the P wave and the QRS complex. LS means were calculated using ANCOVA model with treatment as a fixed effect and the baseline ECG parameter as the covariate.|Baseline, 26 weeks, 52 weeks|Participants who were randomized and received at least one dose of study medication with evaluable ECG data. Only pre-rescue measurements were used. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||milliseconds (msec)||Standard Error|Least Squares Mean
681276|NCT01558271|Secondary|Number of Participants Requiring Additional Intervention Due to Hyperglycemia at 26 Weeks and 52 Weeks|Additional intervention was defined as any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation. The number of participants requiring additional intervention due to hyperglycemia is summarized cumulatively at 26 and 52 weeks.|Baseline through 26 weeks and Baseline through 52 weeks|Participants who received at least one dose of study medication.||participants|||Number
681277|NCT01558271|Secondary|Number of Participants With Treatment-Emergent LY2189265 Anti-Drug Antibodies (ADAs) at 26 Weeks and 52 Weeks|A participant was considered to have treatment-emergent LY2189265 ADAs if the participant had at least 1 titer that was treatment-emergent relative to baseline, defined as a 4-fold or greater increase in titer from the baseline measurement.|Baseline through 26 weeks and Baseline through 52 weeks|Participants who received at least one dose of study medication and had LY2189265 evaluable ADA data.||participants|||Number
681278|NCT01558271|Secondary|Change From Baseline in Serum Calcitonin at 26 Weeks and 52 Weeks||Baseline, 26 weeks, 52 weeks|Participants who were randomized and received at least one dose of study medication with evaluable serum calcitonin data. Only pre-rescue measurements were used. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||picograms/milliliter||Inter-Quartile Range|Median
681279|NCT01558271|Secondary|Change From Baseline in Pancreatic Enzymes at 26 Weeks and 52 Weeks|Pancreatic enzyme (lipase and total amylase) concentrations were measured.|Baseline, 26 weeks, 52 weeks|Participants who were randomized and received at least one dose of study medication with evaluable pancreatic enzyme data. Only pre-rescue measurements were used. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||units/liter||Inter-Quartile Range|Median
681280|NCT01558271|Secondary|Number of Participants With Adjudicated Pancreatitis at 26 Weeks and 52 Weeks|Events of pancreatitis (including suspected pancreatitis and severe or serious abdominal pain) were adjudicated by a committee of expert physicians external to the Sponsor. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 weeks and Baseline through 52 weeks|Participants who received at least one dose of study medication.||participants|||Number
681281|NCT01558271|Secondary|Change From Baseline in Blood Pressure at 26 Weeks and 52 Weeks|Sitting systolic blood pressure (SBP) and sitting diastolic blood pressure (DBP) were measured. LS means were calculated using ANCOVA model with treatment, prestudy therapy (OAM yes/no), and baseline BMI group (<25 or >=25 kg/m^2) as fixed effects and baseline blood pressure as a covariate.|Baseline, 26 weeks, 52 weeks|Participants who were randomized and received at least one dose of study medication with evaluable blood pressure data. Only pre-rescue measurements were used. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||milliliters of mercury (mmHG)||Standard Error|Least Squares Mean
681282|NCT01558271|Secondary|Change From Baseline in Pulse Rate at 26 Weeks and 52 Weeks|Sitting pulse rate was measured. LS means were calculated using ANCOVA model with treatment, prestudy therapy (OAM yes/no), and baseline BMI group (<25 or >=25 kg/m^2) as fixed effects and baseline pulse rate as a covariate.|Baseline, 26 weeks, 52 weeks|Participants who were randomized and received at least one dose of study medication with evaluable pulse rate data. Only pre-rescue measurements were used. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||beats per minute (bpm)||Standard Error|Least Squares Mean
681283|NCT01558271|Secondary|Number of Participants With Adjudicated Cardiovascular Events at 26 Weeks and 52 Weeks|Deaths and nonfatal cardiovascular adverse events were adjudicated by a committee of physicians with cardiology expertise external to the Sponsor. The nonfatal cardiovascular events subjected to adjudication included myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions (such as coronary artery bypass graft or percutaneous coronary intervention), and cerebrovascular events including cerebrovascular accident (stroke) and transient ischemic attack. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 weeks and Baseline through 52 weeks|Participants who received at least one dose of study medication.||participants|||Number
681284|NCT01558271|Secondary|30-Day Rate of Hypoglycemic Episodes|The 30-day total hypoglycemia rate over 26 weeks and 52 weeks of treatment is summarized. All classifications of hypoglycemia (documented symptomatic, asymptomatic, severe, nocturnal, non-nocturnal, probable symptomatic, relative, and unspecified) were included, except for episodes of relative hypoglycemia that were not severe. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 weeks and Baseline through 52 weeks|Participants who received at least one dose of study medication. One participant in the Liraglutide reporting group received study drug but discontinued from the study on the same day and, therefore, was not included in the analysis.||events per participant per 30 days||Standard Deviation|Mean
681320|NCT01557894|Primary|Social Phobia Inventory (SPIN)|"The Social Phobia Inventory (SPIN) is a brief (i.e., 17-item) self-report instrument measuring fear in social situations, avoidance of performance/social events, and physiological discomfort in social situations. Each item is rated on a 4-point scale.
Thus, for SPIN the range of scores is 0-68, with higher scores reflecting higher levels of social anxiety symptomatology"|pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37)|||units on a scale||Standard Deviation|Mean
681285|NCT01558271|Secondary|Percentage of Participants With Hypoglycemic Episodes|The percentage of participants with hypoglycemic episodes was calculated by dividing the number of participants with at least one hypoglycemic episode over the 26-week or 52-week treatment period by the total number of participants analyzed, multiplied by 100%. All classifications of hypoglycemia (documented symptomatic, asymptomatic, severe, nocturnal, non-nocturnal, probable symptomatic, relative, and unspecified) were included, except for episodes of relative hypoglycemia that were not severe. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 weeks and Baseline through 52 weeks|Participants who received at least one dose of study medication.||percentage of participants|||Number
681286|NCT01558271|Secondary|Change From Baseline in Beta-cell Function Using Updated Homeostasis Model Assessment (HOMA 2) at 26 Weeks and 52 Weeks|HOMA 2 quantifies insulin resistance and beta-cell function. HOMA2-B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state beta-cell function (%B) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. Change in beta-cell function was assessed based on change from baseline of HOMA2-%B using fasting insulin (FI) and fasting C-peptide (FCP). LS means were calculated using ANCOVA model with treatment, prestudy therapy (OAM yes/no), and baseline BMI group (<25 or >=25 kg/m^2) as fixed effects and baseline HOMA2-%B as a covariate.|Baseline, 26 weeks, 52 weeks|Participants who were randomized and received at least one dose of study medication with evaluable HOMA2-%B data. Only pre-rescue measurements were used. Missing endpoints were imputed with the LOCF method, using only postbaseline data.||percentage of HOMA2||Standard Error|Least Squares Mean
681287|NCT01558271|Secondary|Change From Baseline in Insulin Sensitivity Using Updated Homeostasis Model Assessment (HOMA 2) at 26 Weeks and 52 Weeks|HOMA 2 quantifies insulin resistance and beta-cell function. HOMA2-S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. Change in insulin sensitivity was assessed based on change from baseline of HOMA2-%S using fasting insulin (FI) and fasting C-peptide (FCP). LS means were calculated using ANCOVA model with treatment, prestudy therapy (OAM yes/no), and baseline BMI group (<25 or >=25 kg/m^2) as fixed effects and baseline HOMA2-%S as a covariate.|Baseline, 26 weeks, 52 weeks|Participants who were randomized and received at least one dose of study medication with evaluable HOMA2-%S data. Only pre-rescue measurements were used. Missing endpoints were imputed with the LOCF method, using only postbaseline data.||percentage of HOMA2||Standard Error|Least Squares Mean
681288|NCT01558271|Secondary|Change From Baseline in Body Weight at 26 Weeks and 52 Weeks|LS means were calculated using MMRM analysis with treatment, visit, treatment-by-visit, prestudy therapy (OAM yes/no), baseline BMI group (<25 or >=25 kg/m^2) as fixed effects, baseline body weight as a covariate, and participant as a random effect.|Baseline, 26 weeks, 52 weeks|Participants who received at least one dose of study medication with evaluable body weight data. Only pre-rescue measurements were used.||kilograms (kg)||Standard Error|Least Squares Mean
681289|NCT01558271|Secondary|Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) at 26 Weeks and 52 Weeks|Participants were to test and record SMBG concentrations in their study diaries before each meal (breakfast, lunch, and dinner), approximately 2 hours after the start of each meal, and at bedtime. LS means were calculated using analysis of covariance (ANCOVA) model with treatment, prestudy therapy (OAM yes/no), and baseline BMI group (<25 or >=25 kg/m^2) as fixed effects and baseline SMBG as a covariate.|Baseline, 26 weeks, 52 weeks|Participants who received at least one dose of study medication with evaluable SMBG data. Only pre-rescue measurements were used. Missing endpoints were imputed with the LOCF method, using only postbaseline data.||milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
681290|NCT01558271|Secondary|Change From Baseline in Fasting Blood Glucose (FBG) at 26 Weeks and 52 Weeks|LS means were calculated using MMRM analysis with treatment, visit, treatment-by-visit, prestudy therapy (OAM yes/no), baseline BMI group (<25 or >=25 kg/m^2) as fixed effects, baseline FBG as a covariate, and participant as a random effect.|Baseline, 26 weeks, 52 weeks|Participants who were randomized and received at least one dose of study medication with evaluable FBG data. Only pre-rescue measurements were used.||milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
681291|NCT01558271|Secondary|Percentage of Participants Who Achieved HbA1c <=6.5% or <7%|The percentage of participants achieving HbA1c level less than 7.0% and less than or equal to 6.5% at Week 26 and Week 52 was analyzed with a Cochran-Mantel-Haenszel test stratified by prestudy therapy (OAM yes/no) and baseline BMI group (<25 or >=25 kg/m^2).|Up to 26 and 52 weeks|Participants who were randomized and received at least one dose of study medication with evaluable HbA1c data. Only pre-rescue measurements were used. Missing endpoints were imputed with the last observation carried forward (LOCF), using only postbaseline data.||percentage of participants|||Number
681292|NCT01558271|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 52 Weeks|LS means were calculated using MMRM analysis with treatment, visit, treatment-by-visit, prestudy therapy (OAM yes/no), baseline BMI group (<25 or >=25 kg/m^2) as fixed effects, baseline HbA1c as a covariate, and participant as a random effect.|Baseline, 52 weeks|Participants who received at least one dose of study medication with evaluable HbA1c data. Only pre-rescue measurements were used.||percentage of HbA1c||Standard Error|Least Squares Mean
681293|NCT01558271|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 26 Weeks|Least squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, visit, treatment-by-visit, prestudy therapy (oral antihyperglycemic medication [OAM] yes/no), baseline body mass index (BMI) group (<25 or >=25 kilograms per meter squared [kg/m^2]) as fixed effects, baseline HbA1c as a covariate, and participant as a random effect.|Baseline, 26 weeks|Participants who received at least one dose of study medication with evaluable HbA1c data. Only pre-rescue measurements were used.||percentage of HbA1c||Standard Error|Least Squares Mean
681294|NCT01558128|Primary|Subject Rhythm|Measuring change from baseline cardiac rhythm.|Participants will be followed for the duration of their hospital stay post surgery with an expected average of 7 to 10 days and again at surgical follow up appointment up to 6 weeks.|Converted to normal sinus rhythm||Participants|||Count of Participants
681427|NCT01556906|Secondary|Absolute Change From Baseline in Ratio of Vitamin E to Total Lipids|Absolute Change From Baseline in ratio of vitamin E to total lipids|Baseline and 16 weeks of treatment|All patients treated||ratio||Standard Deviation|Mean
681295|NCT01558089|Secondary|Predictor of Good EULAR Response Versus Moderate/No Response at Visit 4 (Month 6) - DAS28 (LOCF)|In a first step a univariate logistic regression model was fit for the following baseline variables: DAS28 (n=48), Physician’s Global Assessment of Disease Activity (VAS) (n=47), Patient’s Global Assessment of Disease Activity (VAS) (n=47), CRP (n=46), Patient Pain (VAS) (n=47), HAQ-DI (n=47), EQ-5D (n=47). Only those variables that were significant at a 10% level were then included in the second step: a multivariate analysis with stepwise regression (entry level=10%, stay level=5%). The final model presented in the Basic Results table displays those covariates which were significant at the 2-sided 5% level (baseline value for DAS28; n=48). Note that DAS28 is not a categorical variable; therefore no stratified results for this variable are presented.|Baseline and Visit 4 (Month 6)|The analysis was based on the FAS population. The FAS comprised participants who received at least 1 dose of Methotrexate + Etanercept, and completed at least 1 assessment following first dose.||Odds Ratio (per unit increase)||95% Confidence Interval|Number
681296|NCT01558089|Secondary|Change From Baseline in HAQ-DI at Visit 4 (Month 6)|The Health Assessment Questionnaire-Disability Index (HAQ-DI) is composed of 20 items. It is a participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score ranges from 0-3: 0=least difficulty and 3=extreme difficulty.|Baseline and Visit 4 (Month 6)|The analysis was based on the FAS population. The FAS comprised participants who received at least 1 dose of Methotrexate + Etanercept, and completed at least 1 assessment following first dose.||units on scale||Standard Deviation|Mean
681297|NCT01558089|Secondary|Change From Baseline in EQ-5D Health Index at Visit 4 (Month 6)|The European Quality of Life–5 Dimensions (EQ-5D) was measured on a 5 item scale. The scores for the 5 items (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) ranged from 1 (no problem) to 3 (extreme problems). For EQ-5D, participants rate questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each of the 5 dimensions is divided into 3 levels of perceived problems: Level 1=no problem; level 2=some problem; level 3=extreme problem. A unique health state is defined by combining 1 level from each dimension. A total of 243 possible health states are defined in this way. Each state is referred to in terms of a 5 digit code. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline and Visit 4 (Month 6)|The analysis was based on the FAS population. The FAS comprised participants who received at least 1 dose of Methotrexate + Etanercept, and completed at least 1 assessment following first dose.||units on scale||Standard Deviation|Mean
681298|NCT01558089|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Visit 4 (Month 6)||Baseline and Visit 4 (Month 6)|The analysis was based on the FAS population. The FAS comprised participants who received at least 1 dose of Methotrexate + Etanercept, and completed at least 1 assessment following first dose.||mm/hour||Standard Deviation|Mean
681299|NCT01558089|Secondary|Change From Baseline in Patient’s Assessment of General Health (VAS) at Visit 4 (Month 6)|The patients used a 100 mm Visual Analogue Scale (VAS) to score their general health during the last week. The scale ranged from 0 (no pain) to 100 mm (severe pain)|Baseline and Visit 4 (Month 6)|The analysis was based on the FAS population. The FAS comprised participants who received at least 1 dose of Methotrexate + Etanercept, and completed at least 1 assessment following first dose.||mm||Standard Deviation|Mean
681300|NCT01558089|Secondary|Change From Baseline in Swollen Joint Count at Visit 4 (Month 6)|In order to calculate the DAS28 the number of swollen joints and tender joints were assessed using the 28 Joint Count (TJC28 and SJC28). A joint was counted as tender/swollen if the tender/swelling code was ‘Present’. Swollen and tender 28 joint counts will be performed at visit 1 (baseline), visit 2, visit 3 and visit 4 or early withdrawal.|Baseline and Visit 4 (Month 6)|The analysis was based on the FAS population. The FAS comprised participants who received at least 1 dose of Methotrexate + Etanercept, and completed at least 1 assessment following first dose.||Joints||Standard Deviation|Mean
681301|NCT01558089|Secondary|Change From Baseline in Tender Joint Count at Visit 4 (Month 6)|In order to calculate the DAS28 the number of swollen joints and tender joints were assessed using the 28 Joint Count (TJC28 and SJC28). A joint was counted as tender/swollen if the tender/swelling code was ‘Present’. Swollen and tender 28 joint counts will be performed at visit 1 (baseline), visit 2, visit 3 and visit 4 or early withdrawal.|Baseline and Visit 4 (Month 6)|The analysis was based on the Full Analysis Set (FAS) population. The FAS comprised participants who received at least 1 dose of Methotrexate + Etanercept, and completed at least 1 assessment following first dose.||Joints||Standard Deviation|Mean
681302|NCT01558089|Primary|Primary: Participants With EULAR (Good)|Good European League Against Rheumatism (EULAR) response at 6 months based on DAS28 EULAR response criteria defined as Good response = DAS28 change >1.2 with DAS28 ≤3.2; Moderate response = DAS28 change >0.6 with DAS28 >3.2-5.1; Non-response = DAS28 change ≤0.6 and absolute DAS28 >5.1|Visit 4 (Month 6)|Last observation carried forward (LOCF) was applied where data were available. Participants where a EULAR response value could not be calculated, were omitted from the analysis. Only 48 Participants had available EULAR response data at 6 months.||participants|||Number
681303|NCT01557959|Secondary|Median Survival Among Subgroups of Patients According to Molecular Profiles Including Tumor Characteristics and Genetic Polymorphisms From Peripheral Blood||2 years||||||
681304|NCT01557959|Secondary|Median Survival Among Subgroups of Patients According to Molecular Profiles Including Tumor Characteristics and Genetic Polymorphisms From Peripheral Blood||1 year||||||
681305|NCT01557959|Secondary|Response Rate Among Subgroups of Patients According to Molecular Profiles Including Tumor Characteristics and Genetic Polymorphisms From Peripheral Blood||2 years||||||
681306|NCT01557959|Secondary|Response Rate Among Subgroups of Patients According to Molecular Profiles Including Tumor Characteristics and Genetic Polymorphisms From Peripheral Blood||1 year||||||
681428|NCT01556906|Secondary|Absolute Change From Baseline in Vitamin D|Absolute Change From Baseline in Vitamin D|Baseline and 16 weeks of treatment|All patients treated||nmol/L||Standard Deviation|Mean
681429|NCT01556906|Secondary|Absolute Change From Baseline in Vitamin E|Absolute change from Baseline in vitamin E|Baseline and 16 weeks of treatment|All patients treated||umol/L||Standard Deviation|Mean
681307|NCT01557959|Primary|Time to Progression|Determined using RECIST. Estimated using the Kaplan-Meier method. Log-rank tests will be used to test for differences and Cox proportional hazards regression modeling will be used to adjust for patient demographics and characteristics such as smoking status at baseline (actively/non-actively smoking). Progression is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|2 years|||months||95% Confidence Interval|Median
681308|NCT01557946|Secondary|Mean Difference From Baseline to Day 7 in Glutamine/Glutamate (Gln/Glu) Ratio Within Depressed Group|Estimated mean difference (day 7 minus baseline) in the glutamine/glutamate (Gln/Glu) ratio in the rostral anterior cingulate cortex as measured by proton magnetic resonance spectroscopy from baseline to day 7 of citalopram treatment within the depressed group. The change in metabolites from baseline to each time point was assessed by random regression analysis, adjusting for age and sex, using generalized estimating equations to account for the correlation of observations within individuals.|Change from baseline to day 7|One participant's day 7 scan was corrupted during data transfer and could not be recovered. Results are only presented for participants with depression as healthy control participants were only scanned once.||arbitrary units||Standard Error|Mean
681309|NCT01557946|Primary|Mean Difference From Baseline to Day 3 in Glutamine/Glutamate (Gln/Glu) Ratio Within Depressed Group|Estimated mean difference (day 3 minus baseline) in the glutamine/glutamate (Gln/Glu) ratio in the rostral anterior cingulate cortex as measured by proton magnetic resonance spectroscopy from baseline to day 3 of citalopram treatment within the depressed group. The change in metabolites from baseline to each time point was assessed by random regression analysis, adjusting for age and sex, using generalized estimating equations to account for the correlation of observations within individuals.|Change from Baseline to Day 3|One participant lacked a day 3 scan; one participant's day 3 scan was corrupted during data transfer and could not be recovered; and one participant's day 3 scan data was judged to be unusable due to poor spectral quality. Results are only presented for participants with depression as healthy control participants were only scanned once.||arbitrary units||Standard Error|Mean
681310|NCT01557920|Post-Hoc|Frequency of Spontaneous Swallows During Anesthesia vs Wakefulness|The number of swallows were counted during wakefulness and anesthesia. The frequency of swallowing was calculated per hour|swallows were measured during steady state conditions (mean±SEM, 2.6±0.6h)|224 swallows in 11 out of 12 subjects were analyzed (1 excluded due to faulty recording of swallows). If the pathological swallow incidence between sevoflurane and propofol anesthesia had a p-value >0.05, subsequent analyses were conducted to evaluate depth of anesthesia related differences rather than compound specific ones.||number of swallows/hr||Standard Deviation|Mean
681311|NCT01557920|Secondary|Duty Cycle|(T(ins)/T(total))*100|Will be measured before and during anesthesia until emergence from anesthesia, an expected average of 6 hours|In one subject we could not record high quality biologically plausible recordings of Duty cycle.||percentage of Ttotal||Standard Deviation|Mean
681312|NCT01557920|Secondary|Minute Ventilation (Tidal Volume and Respiratory Rate)|Measured by spirometry. Subjects wear a full-face mask. Reported in L/min|Will be measured before and during anesthesia until emergence from anesthesia, an expected average of 6 hours|In one subject we could not record high quality biologically plausible recordings of minute ventilation.||L/min||Standard Deviation|Mean
681313|NCT01557920|Secondary|Genioglossus Muscle Electromyogram|will be measured during steady state anesthesia as well as during carbon dioxide reversal, and during recovery from anesthesia.|participants will be followed for the duration of anesthesia until full recovery, an expected average of 9 hours|The number of participants in this group are only 9 since the genioglossus EMG signals were poor in 2 participants and these were excluded from the analysis.||percentage of maximum recorded activity||Standard Error|Mean
681314|NCT01557920|Secondary|Airway Diameter|Using acoustic pharyngometry, we intend to measure the cross-sectional area of the airway at several points during recovery from anesthesia.|participants will be followed for the duration of anesthesia until full recovery, an expected average of 9 hours|No data were obtained.|||||
681315|NCT01557920|Primary|Proportion of Pathological Swallows|A pathological swallow was defined as a swallow that was followed by inspiratory flow. A physiological swallow was defined as a swallow that was followed by expiratory flow. The number of pathological and physiological swallows were measured during wakefulness and anesthesia. The pathological swallows are presented as percentage of path. swallows calculated as path.sw/[path.sw+phys.sw]*100 (%).|swallows were measured during steady state conditions (mean±SEM, 2.6±0.6h)|224 swallows in 11 out of 12 subjects were analyzed (1 excluded due to faulty recording of swallows).||percentage of pathological swallows|||Number
681316|NCT01557920|Primary|Upper Airway Closing Pressure|Upper airway closing pressure will be measured during steady state anesthesia as well as during carbon dioxide reversal.|participants will be followed for the duration of anesthesia, an expected average of 6 hours|Ten out of 12 subjects were analyzed. In two subjects we could not record high quality biologically plausible recordings of upper airway closing pressure. Data from multiple measurements per participant were combined to calculate an average upper airway closing pressure per subject.||cm H20||Standard Deviation|Mean
681317|NCT01557894|Secondary|Anxiety Sensitivity Index (ASI)|The Anxiety Sensitivity Index (ASI) is a 16-item questionnaire that measures the beliefs about the social and somatic consequences of anxiety symptoms. The total ASI score ranges from 0 to 64, with higher scores corresponding to greater anxiety sensitivity.|pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37)|||units on a scale||Standard Deviation|Mean
681318|NCT01557894|Secondary|Attitude and Belief Scale-II (ABS-II)|"The Attitude and Belief Scale-II (ABS-II) measures rational and irrational thinking as described by Albert Ellis. The scale was designed to capture four cognitive processes (i.e., demandingness, awfulizing, low frustration tolerance, and self-downing/global evaluation) in three content areas (i.e., achievement, approval, and comfort). We selected the 72-item ABS-II because preliminary psychometrics are available for the Romanian population.
The total ABS-II score range from 0 to 360, with higher scores corresponding to greater irrationality."|pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37)|||units on a scale||Standard Deviation|Mean
681430|NCT01556906|Secondary|Absolute Change From Baseline in Vitamin A|Absolute change from Baseline in vitamin A|Baseline and 16 weeks of treatment|All patients treated||µmol/L||Standard Deviation|Mean
681321|NCT01557894|Primary|Leibowitz Social Anxiety Scale - Self Report (LSAS-SR)|"The Leibowitz Social Anxiety Scale - Self Report (LSAS-SR) measures social anxiety.
LSAS-SR presents 24 commonly anxiety-provoking situations, and asks participants to rate their fear and avoidance for each situation.
In order to obtain the total LSAS-SR score the Anxiety and Avoidance subscales scores are added together.
The LSAS-SR total score ranges from 0-144, with higher scores corresponding to greater social anxiety"|pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37)|||units on a scale||Standard Deviation|Mean
681322|NCT01557868|Secondary|Visual Analogue Scale (VAS) at 6 Months|The VAS is a patient-reported assessment of knee pain. Patients mark on a line (0-100mm) their current level of knee pain while moving where 0 represent no pain and 100 represents maximum pain. We report changes in VAS pain rating between baseline and 6 month follow-up. Therefore scores can theoretically range from -100 (moving from maximum pain to no pain) to 100 (moving from no pain to maximum pain). Negative change scores represent decreases in perceived pain or improvement.|Assessments were at baseline to 6 month follow-up|The discrepancy between the number of subjects included in this analysis (140) and the number of subjects reported completing the study (141) is due to a missing values for one subject for this variable.||units on a scale||Standard Deviation|Mean
681323|NCT01557868|Primary|Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Scale|"The KOOS is 42-item patient-report questionnaire that assesses symptoms and problems associated with knee injury and osteoarthritis. It yields scores for five scales including Pain, Other Symptoms, Function in Daily Living, Function in Sport/Recreation, and Knee-Related Quality of Life. We used only the Pain scale which has a range of 0 to 100 where 100 represents the best score, i.e., no pain. We reported differences in baseline Pain scale score from Pain scale score at 6 months so these scores could theoretically range from -100 (moving from no pain to maximum pain) to 100 (moving from maximum pain to no pain). Positive change scores represent improvement from baseline."|Baseline and at 6 month follow-up|||units on a scale||Standard Deviation|Mean
681324|NCT01557842|Primary|Cardiac-related Death|Subjects with cardiac-related death|2 years follow up|All enrolled subjects||percentage of participants|||Number
681325|NCT01557842|Primary|Percentage of Subjects Who Had Hospitalization for Ventricular Tachycardia (VT) Related Causes/Events|The hospital admission date must occur after completing the 1-month follow-up visit for the event to be considered an effectiveness failure.|From one month to 2 years follow up|All enrolled subjects||percentage of participants|||Number
681326|NCT01557699|Secondary|Geometric Mean Titre (GMT) by PRNT on Day -7, 28 and 84|Geometric Mean Titre by Plaque Reduction Neutralization Test were assessed on Day -7, 28 and 84 at CDC, Atlanta. Titers are expressed as IU/ml.|Day -7, Day 28 and Day 84|Per Protocol (PP) Population was for the Immunogenicity analysis & included subjects who received a dose of the study vaccine and met all inclusion/ exclusion criteria and complied with study procedures as defined in the study protocol, did not show any major protocol violation and gave baseline (Day -7) and Day 28 immunogenicity blood samples.||IU/ml||95% Confidence Interval|Geometric Mean
681327|NCT01557699|Secondary|Geometric Mean Concentration (GMC) for Anti-Measles IgG Antibodies|Geometric Mean Concentration (GMC) for anti-Measles IgG antibodies were measured on Day -7, Day 28 and Day 84 by ELISA using Trinity ELISA Kits for Measles.|Day -7, Day 28 and Day 84|Per Protocol (PP) Population was for the Immunogenicity analysis & included subjects who received a dose of the study vaccine and met all inclusion/ exclusion criteria and complied with study procedures as defined in the study protocol, did not show any major protocol violation and gave baseline (Day -7) and Day 28 immunogenicity blood samples.||IU/ml||95% Confidence Interval|Geometric Mean
681328|NCT01557699|Secondary|The Proportion of Subjects in Each Group With Seroconversion for PRNT|The proportion of subjects in each group who show a seroconversion for PRNT on Day 28 and Day 84 was assessed.|Day 28 and Day 84|Per Protocol (PP) Population was for the Immunogenicity analysis & included subjects who received a dose of the study vaccine and met all inclusion/ exclusion criteria and complied with study procedures as defined in the study protocol, did not show any major protocol violation and gave baseline (Day -7) and Day 28 immunogenicity blood samples.||percentage of participants|||Number
681329|NCT01557699|Secondary|The Proportion of Subjects in Each Group With Seroconversion for Serum Anti-Measles IgG|The proportion of subjects in each group who show a seroconversion for serum anti-Measles IgG on Day 28 and Day 84 was assessed.|Day 28 and Day 84|Per Protocol Population was used for the Immunogenicity analysis which included subjects who received a dose of the study vaccine and met all inclusion/ exclusion criteria and complied with study procedures as defined in the study protocol, did not show any major protocol violation and gave baseline (Day -7) and Day 28 blood samples.||percentage of participants|||Number
681330|NCT01557699|Secondary|The Proportion of Subjects in Each Group With Seroprotective Plaque-reduction Neutralization Test (PRNT) Titre|The proportion of subjects in each group with seroprotective plaque-reduction neutralization test (PRNT) titre on Day -7, Day 28 and Day 84 was assessed.|Day -7, Day 28 and Day 84|Per Protocol (PP) Population was used for the Immunogenicity analysis which included subjects who received a dose of the study vaccine and met all inclusion/ exclusion criteria and complied with study procedures as defined in the study protocol, did not show any major protocol violation and gave baseline (Day -7) and Day 28 blood samples.||percentage of participants|||Number
681331|NCT01557699|Secondary|The Proportion of Subjects in Each Group With Seropositive Anti-Measles IgG Antibodies|The proportion of subjects in each group with seropositive anti-Measles IgG antibodies on Day -7, Day 28 and Day 84 was assessed.|Day -7, Day 28 and Day 84|Per Protocol (PP) Population was for the Immunogenicity analysis & included subjects who received a dose of the study vaccine and met all inclusion/ exclusion criteria and complied with study procedures as defined in the study protocol, did not show any major protocol violation and gave baseline (Day -7) and Day 28 immunogenicity blood samples.||percentage of participants|||Number
681332|NCT01557699|Primary|Incidence of Serious Adverse Events (SAEs) and New Onset Chronic Medical Conditions|Incidence of serious adverse events (SAEs) and new onset chronic medical conditions throughout the entire study period of 180 days in each group was assessed.|Day 180|Intention-To-Treat (ITT) Population was used for safety and immunogenicity analysis. ITT population included subjects who had blood drawn to confirm a measles protective titer at Day -7 and met all inclusion/ exclusion criteria and did not receive a vaccine forbidden in the study protocol within the previous 30 days.||participants|||Number
681333|NCT01557699|Primary|Incidence of Unsolicited Adverse Events Within 84 Days|Incidence of unsolicited adverse events for a period of 84 days in each group was assessed.|Day 84|Intention-To-Treat (ITT) Population was used for safety analysis.||participants|||Number
681334|NCT01557699|Primary|Incidence of Solicited Reactions|Incidence of solicited local and systemic reactions within 14 days of vaccine administration in each group was assessed.|Day 14|Intention-To-Treat (ITT) Population included all subjects who received at least one dose of study vaccine and had at least one post-baseline assessment, regardless of whether they adhered to the study eligibility criteria or whether their study medication administration and study procedure visits are within the protocol-specified windows.||participants|||Number
681335|NCT01557595|Secondary|Wake Up and Bedtime Diaries|At the screen visit, participants will receive 7 sets of Wake Up and Bedtime Diaries and be instructed to complete them twice daily. At the baseline visit, the completed diaries will be retrieved, and participants will be given 14 sets of Wake Up and Bedtime Diaries. Participants will also be given the polarized glasses to wear from sundown until bedtime for 2 weeks. Diaries will be filled out daily for 2 weeks. All forms will be collected with the glasses after the 2 weeks, at the termination visit.|Change from baseline in diaries at 2 weeks||||||
681336|NCT01557595|Primary|Change in Pittsburgh Sleep Quality Index (PSQI) at 2 Weeks After Baseline|The PSQI is a validated self-rating instrument assessing aspects of sleep quality.Minimum score 0 (better); maximum score 21 (worse) < or = 5 associated with good sleep quality; > 5 associated with poor sleep quality. (calculated subtracting baseline scores from score at 2 weeks) A positive mean score would reflect an improvement. The PSQI is considered appropriate in identifying “new-onset” insomnia in the clinical setting.|2 weeks post baseline|||units on a scale||Full Range|Mean
681337|NCT01557582|Secondary|Intra-Observer Variability|Intra-Observer Variation: Directional Difference within Observer (Reading 2-Reading 1)|VMS occured on day 1 and required 15 minutes and MRI occurred on day 1 and required 1 hour.|||Percent difference||Standard Deviation|Mean
681338|NCT01557582|Secondary|Inter-Observer Variability|A VMS/echo inter-observer analysis of VMS between-Observer Variation for N=75 Studies.|VMS occured on day 1 and required 15 minutes and MRI occurred on day 1 and required 1 hour.|All evaluable subjects.||Percent difference||Standard Deviation|Mean
681339|NCT01557582|Primary|Observed Mean (Std Err) for % Difference Between VMS and MRI.|% Difference was measured for right ventricular EDV, ESV and EF.|VMS occured on day 1 and required 15 minutes and MRI occurred on day 1 and required 1 hour.|Only evaluable participants were analyzed||Percent difference||Standard Error|Mean
681340|NCT01557569|Primary|Time Till Relapse|The number of days until a participant has a relapse, which will be measured by qualitative urine drug screens. To ensure a large enough sample, those who drop out prior to completing the residential stay will be included in this analysis (with minus days until relapse)|57 days|Only 4 of 13 finished the 2-week residential stay. Since subjects who drop out are deemed relapsed, all subjects receiving >/=1 dose of study med were included in the analyses. Those who dropped out before completing the residential stay were considered relapsed by the second day and the date of discharge was subtracted from this relapse date.||Days to Relapse||Full Range|Median
681341|NCT01557504|Primary|Number of Participants Who Discontinued Study Drug Due to an AE|An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.|Up to 9 days|All participants as treated defined as all participants who received at least one dose of study drug.||Participants|||Number
681342|NCT01557504|Primary|Number of Participants Who Experienced an Abnormal Vital Sign Value|Vital sign measurements included blood pressure, heart rate, respiratory rate, and oral temperature.|Up to 23 days (including approximately 10 to 14 days after the last dose of study drug)|All participants as treated defined as all participants who received at least one dose of study drug.||Participants|||Number
681343|NCT01557504|Primary|Number of Participants Who Experienced an Adverse Event (AE)|An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.|Up to 23 days (including approximately 10 to 14 days after the last dose of study drug)|All participants as treated defined as all participants who received at least one dose of study drug.||Participants|||Number
681344|NCT01557504|Primary|Apparent Terminal Half Life (t1/2) of Sitagliptin Following Single Dose Administration of Sitagliptin/Metformin XR|In this study, metformin products were withheld 24 hours prior to sitagliptin/metformin XR administration and were permitted to re-initiate 24 hours post study drug administration. Owing to resumption of therapeutic metformin administration 24 hours after sitagliptin/metformin XR administration for all participants, metformin pharmacokinetic analyses were restricted to Cmax, Tmax and AUC0-24hr. Therefore, metformin arm is not included in this outcome measure.|Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, and 72 hours post-dose|Per protocol population defined as all participants who completed at least one period of treatment and had available data.||Hour||Geometric Coefficient of Variation|Geometric Mean
681345|NCT01557504|Primary|Tmax of Sitagliptin and Metformin Following Single Dose Administration of Sitagliptin/Metformin XR|In this study, metformin products were withheld 24 hours prior to sitagliptin/metformin XR administration and were permitted to re-initiate 24 hours post study drug administration.|Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, and 72 hours post-dose|Per protocol population defined as all participants who completed at least one period of treatment and had available data.||Hour||Full Range|Median
681346|NCT01557504|Primary|Cmax of Metformin Following Single Dose Administration of Sitagliptin/Metformin XR|In this study, metformin products were withheld 24 hours prior to sitagliptin/metformin XR administration and were permitted to re-initiate 24 hours post study drug administration. Due different units of measure for sitagliptin and metformin, sitagliptin data are presented in another outcome measure.|Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, and 72 hours post-dose|Per protocol population defined as all participants who completed at least one period of treatment and had available data.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
681347|NCT01557504|Primary|Cmax of Sitagliptin Following Single Dose Administration of Sitagliptin/Metformin XR|Due different units of measure for sitagliptin and metformin, metformin data are presented in another outcome measure.|Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, and 72 hours post-dose|Per protocol population defined as all participants who completed at least one period of treatment and had available data.||nM||Geometric Coefficient of Variation|Geometric Mean
681348|NCT01557504|Primary|Area Under the Curve 0 to Infinity (AUC 0-∞) of Sitagliptin Following Single Administration of Sitagliptin/Metformin XR|In this study, metformin products were withheld 24 hours prior to sitagliptin/metformin XR administration and were permitted to re-initiate 24 hours post study drug administration. Owing to resumption of therapeutic metformin administration 24 hours after sitagliptin/metformin XR administration for all participants, metformin pharmacokinetic analyses were restricted to Cmax, Tmax and AUC0-24hr. Therefore, metformin arm is not included in this outcome measure.|Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, and 72 hours post-dose|Per protocol population defined as all participants who completed at least one period of treatment and had available data.||nM*hr||Geometric Coefficient of Variation|Geometric Mean
681349|NCT01557504|Primary|AUC 0-24 of Metformin Following Single Administration of Sitagliptin/Metformin XR|In this study, metformin products were withheld 24 hours prior to sitagliptin/metformin XR administration and were permitted to re-initiate 24 hours post study drug administration. Due different units of measure for sitagliptin and metformin, sitagliptin data are presented in another outcome measure.|Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, and 24 hours post-dose|Per protocol population defined as all participants who completed at least one period of treatment and had available data.||nM*hr/mL||Geometric Coefficient of Variation|Geometric Mean
681350|NCT01557504|Primary|AUC 0-24 of Sitagliptin Following Single Administration of Sitagliptin/Metformin XR|Due different units of measure for sitagliptin and metformin, metformin data are presented in another outcome measure.|Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, and 24 hours post-dose|Per protocol population defined as all participants who completed at least one period of treatment and had available data.||nM*hr||Geometric Coefficient of Variation|Geometric Mean
681351|NCT01557504|Primary|Area Under the Curve 0 to Last (AUC 0-last) of Sitagliptin Following Single Administration of Sitagliptin/Metformin XR|In this study, metformin products were withheld 24 hours (hrs) prior to sitagliptin/metformin XR administration and were permitted to re-initiate 24 hrs post study drug administration. Owing to resumption of therapeutic metformin administration 24 hrs after sitagliptin/metformin XR administration for all participants, metformin pharmacokinetic analyses were restricted to maximum plasma concentration (Cmax), time to maximum plasma concentration (Tmax) and area under the curve 0 to 24 hrs (AUC0-24hr). Therefore, metformin arm is not included in this outcome measure.|Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, and 72 hours post-dose|Per protocol population defined as all participants who completed at least one period of treatment and had available data.||nM*hr||Geometric Coefficient of Variation|Geometric Mean
681352|NCT01557504|Primary|Number of Participants Who Successfully Swallowed Study Med on Day 9|The Swallowing Ability Questionnaire was completed on Day 9 after the participant received two matching placebo tablets (excluding marking) following consumption of a low- to moderate-fat meal in pediatric participants aged 10 to 17 years. The questionnaire consisted of five parts: could only swallow study med with help, easy to start swallowing study med, easy to swallow study med, felt like study med got stuck in throat, and had to swallow study med more than once. The number of participants who strongly agreed or agreed in each of the five parts is reported.|Day 9|Per protocol population defined as all participants who completed at least one period of treatment and had available data. On Day 9, all participants received matching placebo, so the two treatment groups were pooled on Day 9.||Participants|||Number
681353|NCT01557504|Primary|Number of Participants Who Successfully Swallowed Study Med on Day 6|The Swallowing Ability Questionnaire was completed on Day 6 after the participant received two matching placebo tablets (excluding marking) following consumption of a low- to moderate-fat meal in pediatric participants aged 10 to 17 years. The questionnaire consisted of five parts: could only swallow study med with help, easy to start swallowing study med, easy to swallow study med, felt like study med got stuck in throat, and had to swallow study med more than once. The number of participants who strongly agreed or agreed in each of the five parts is reported.|Day 6|Per protocol population defined as all participants who completed at least one period of treatment and had available data. On Day 6, all participants received matching placebo, so the two treatment groups were pooled on Day 6.||Participants|||Number
681354|NCT01557504|Primary|Number of Participants Who Successfully Swallowed Study Med on Day 4|The Swallowing Ability Questionnaire was completed on Day 4 after the participant received two matching placebo tablets (excluding marking) following consumption of a low- to moderate-fat meal in pediatric participants aged 10 to 17 years. The questionnaire consisted of five parts: could only swallow study med with help, easy to start swallowing study med, easy to swallow study med, felt like study med got stuck in throat, and had to swallow study med more than once. The number of participants who strongly agreed or agreed in each of the five parts is reported.|Day 4|Per protocol population defined as all participants who completed at least one period of treatment and had available data. On Day 4, all participants received matching placebo, so the two treatment groups were pooled on Day 4.||Participants|||Number
681355|NCT01557504|Primary|Number of Participants Who Successfully Swallowed Study Medication (Med) on Day 2|The Swallowing Ability Questionnaire was completed on Day 2 after the participant received two matching placebo tablets (excluding marking) following consumption of a low- to moderate-fat meal in pediatric participants aged 10 to 17 years. The questionnaire consisted of five parts: could only swallow study med with help, easy to start swallowing study med, easy to swallow study med, felt like study med got stuck in throat, and had to swallow study med more than once. The number of participants who strongly agreed or agreed in each of the five parts is reported.|Day 2|Per protocol population defined as all participants who completed at least one period of treatment and had available data. On Day 2, all participants received matching placebo, so the two treatment groups were pooled on Day 2.||Participants|||Number
681356|NCT01557348|Secondary|Factors Related to Selection of Second Biologic Therapy Following an Insufficient Response or Intolerance to a Single Previous TNFi|The factors included participant characteristics and the reasons that led to the selection of second biologic therapy following an insufficient response or intolerance to a single previous TNFi. The participant characteristics included participant's option for treatment and option for follow-up. The other reasons included RA disease (rheumatoid factor [RF] and cyclic citrullinated peptide [CCP] status), primary failure, and new treatment characteristics (rapidity of action, route of administration, frequency of administration, low infectious risk, and no lymphoma risk). Participants were included in more than one of these factors.|Baseline|Safety analysis population included all enrolled participants with only one previous TNFi whose second biologic therapy and reason for changing biologic therapy was known.||participants|||Number
681357|NCT01557348|Secondary|Number of Participants With Previous Non-biologic Disease-modifying Anti-rheumatic Drugs Therapy|The previous disease-modifying anti-rheumatic drugs therapy included auranofin, aurothioglucose, aurotioprol, azathioprine, chloroquine, ciclosporin, gold, hydroxychloroquine, infliximab, leflunomide, methotrexate, methotrexate sodium, minocycline, penicillamine, sodium aurothiomalate, sodium aurotiosulfate, sulfasalazine, and tiopronin. Number of participants with previous disease-modifying anti-rheumatic drugs therapy was reported.|Day 1 (Study entry visit)|The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis. Participants with available data at specified time points are denoted as ‘n’.||participants|||Number
681358|NCT01557348|Secondary|Number of Participants With Previous TNFi Therapy|The previous TNFi therapy included adalimumab, etanercept, infliximab, and others (certolizumab, and golimumab). Number of participants with previous TNFi therapy history was reported.|Day 1 (Study entry visit)|The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis. Participants with available data at specified time points are denoted as ‘n’.||participants|||Number
681359|NCT01557348|Secondary|Number of Participants With Reasons for Discontinuation of the First TNFi Therapy|The reasons for discontinuation of first TNFi therapy included inefficacy, intolerance and other reasons. The other reasons included complete remission and participants' non-compliance.|Day 1 (Study entry visit)|The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis.||participants|||Number
681360|NCT01557348|Secondary|Number of Participants With Any Adverse Events, Any Serious Adverse Event, Adverse Events Leading to Withdrawal, and Death|An Adverse event is defined as any unfavorable and unintended medical occurrence/sign (including an abnormal laboratory finding), symptom or disease in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A serious adverse event is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is medically significant or requires intervention to prevent one or other of the outcomes listed above.|Up to 12 Months|Safety analysis population included all enrolled participants with only one previous TNFi whose second biologic therapy and reason for changing biologic therapy was known.||participants|||Number
681361|NCT01557348|Secondary|Reasons for Stopping the Second Biologic Therapy and Subsequent Therapy Choice||Up to 12 months|Safety analysis population included all enrolled participants with only one previous TNFi whose second biologic therapy (ie,Treatment Group) and reason for changing biologic therapy was known.||Number of participants|||Number
681362|NCT01557348|Secondary|Percentage of Participants Who Remained on Their Second Biologic Therapy at Months 6 and 12 After Start of Second Biologic Therapy|Percentage of participants who remained on their second biologic therapy at 6 and 12 months after start of second biologic therapy were reported.|Month 6 and Month 12|Safety analysis population included all enrolled participants with only one previous TNFi whose second biologic therapy (i.e,Treatment Group) and reason for changing biologic therapy was known.||Percentage of participants|||Number
681363|NCT01557348|Secondary|Least Squares Mean Change From Baseline in Duration of Morning Stiffness at Months 6 and 12|Duration of morning stiffness is defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes. Participants with available data at the time of assessment were included in the analysis.|Baseline, Month 6, and Month 12|The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at Baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis. Participants with available data at specified time points were analyzed and are denoted as ‘n’.||minutes||Standard Error|Least Squares Mean
681364|NCT01557348|Secondary|Least Squares Mean Change From Baseline in Health Assessment Questionnaire-Disability Index at Months 6 and 12|Health Assessment Questionnaire-Disability Index (HAQ-DI) is participant reported assessment of ability to perform tasks in 8 categories of daily living activities as dress/groom, arise, eat, walk, reach, grip, hygiene, and common activities over past week. Each item was scored on a 4-point scale from 0 to 3, where 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. Overall score was computed as the sum of domain scores divided by the number of domains answered. Total possible score range was 0-3, where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Month 6, and Month 12|The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at Baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis. Participants with available data at specified time points were analyzed and are denoted as ‘n’.||scores on a scale||Standard Error|Least Squares Mean
681365|NCT01557348|Secondary|Least Squares Mean Change From Baseline in Participant’s VAS Pain Score at Months 6 and 12|Participants were asked to assess their pain intensity (severity of pain) on a 100-millimeter (mm) VAS with the left edge (0 mm) defined as “no pain” and the right edge (100 mm) defined as “severest pain”. Higher scores indicate worsening of disease.|Baseline, Month 6, and Month 12|The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at Baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis. Participants with available data at specified time points were analyzed and are denoted as ‘n’.||mm||Standard Error|Least Squares Mean
681366|NCT01557348|Secondary|Least Squares Mean Change From Baseline in Patient Global Assessment of Disease at Months 6 and 12|Patient Global Assessment of Disease was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity and 100 mm = highest possible disease activity. Higher scores indicate worsening of disease.|Baseline, Month 6, and Month 12|The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at Baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis. Participants with available data at specified time points were analyzed and are denoted as ‘n’.||mm||Standard Error|Least Squares Mean
681367|NCT01557348|Secondary|Least Squares Mean Change From Baseline in Physician Global Assessment of Disease at Months 6 and 12|Physician global assessment of disease was measured on a 0 to 100 millimeter (mm) visual analog scale (VAS), with 0 mm = no disease activity and 100 mm = highest possible disease activity. Higher scores indicate worsening of disease.|Baseline, Month 6, and Month 12|The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at Baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis. Participants with available data at specified time points were analyzed and are denoted as ‘n’.||mm||Standard Error|Least Squares Mean
681368|NCT01557348|Secondary|Least Squares Mean Change From Baseline in ESR at Months 6 and 12|The ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells sediment in a period of one hour. Normal range is 0-30 mm/hr. A reduction in the level of ESR is considered as an improvement in disease activity.|Baseline, Month 6, and Month 12|The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at Baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis. Participants with available data at specified time points were analyzed and are denoted as ‘n’.||mm/hr||Standard Error|Least Squares Mean
681369|NCT01557348|Secondary|Least Squares Mean Change From Baseline in C-reactive Protein at Months 6 and 12|C-reactive protein (CRP) is an inflammation marker. Normal range is from 0-10 milligram/Liter. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement in disease activity.|Baseline, Month 6, and Month 12|The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at Baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis. Participants with available data at specified time points were analyzed and are denoted as ‘n’.||milligram/Liter||Standard Error|Least Squares Mean
681370|NCT01557348|Secondary|Least Squares Mean Change From Baseline in SJC at Months 6 and 12|The SJC is the most specific clinical method to quantify abnormalities in participants with RA. A total of 28 joints were assessed for swelling. Decrease in the score indicated improvement in disease activity.|Baseline, Month 6, and Month 12|The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at Baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis. Participants with available data at specified time points were analyzed and are denoted as ‘n’.||swollen joints||Standard Error|Least Squares Mean
681371|NCT01557348|Secondary|Least Squares Mean Change From Baseline in TJC at Months 6 and 12|The TJC is the most specific clinical method to quantify abnormalities in participants with rheumatoid arthritis (RA). A total of 28 joints were assessed for tenderness. Decrease in score indicated an improvement in disease activity.|Baseline, Month 6, and Month 12|The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at Baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis. Participants with available data at specified time points were analyzed and are denoted as ‘n’.||tender joints||Standard Error|Least Squares Mean
681372|NCT01557348|Secondary|Least Squares Mean Change From Baseline in Disease Activity Score (3 Variables)-Erythrocyte Sedimentation Rate at Month12|The DAS28-3 (ESR) is a measure of disease activity in rheumatoid arthritis. It is calculated from the number of swollen joint count (SJC) and tender joint count (TJC) using the 28 joints count, and ESR (millimeters per hour [mm/hr]). Total score ranges from 0 to 9.4, where higher score indicated more disease activity. Decrease in score indicated improvement in disease activity.|Baseline (Day of change in biologic therapy [<=Day 1]) and Month 12|The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at Baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis.||scores on a scale||Standard Error|Least Squares Mean
681373|NCT01557348|Primary|Least Squares Mean Change From Baseline in Disease Activity Score (3 Variables)-Erythrocyte Sedimentation Rate at Month 6|The DAS28-3 (ESR) is a measure of disease activity in rheumatoid arthritis. It is calculated from the number of swollen joint count (SJC) and tender joint count (TJC) using the 28 joints count, and ESR (millimeters per hour [mm/hr]). Total score ranges from 0 to 9.4, where higher score indicated more disease activity. Decrease in score indicated improvement in disease activity.|Baseline (Day of change in biologic therapy [<=Day 1]) and Month 6|The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at Baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis.||scores on a scale||Standard Error|Least Squares Mean
681374|NCT01557322|Other Pre-specified|Change From Baseline in Euro Quality of Life - 5 Dimensions (EQ-5D) at Month 6|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Month 6|Data not analyzed due to low number of participants available for this measure in BSRBR used for analysis.|||||
681375|NCT01557322|Other Pre-specified|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Month 6|The 36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical component score (PCS) and mental component score (MCS). Total of 3 variables were analyzed (2 composite subscales and vitality score). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline, Month 6|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants evaluable at each time-point for each treatment arm, respectively.||units on a scale||Standard Error|Mean
681431|NCT01556906|Secondary|Absolute Change From Baseline in Carbon Monoxide Lung Diffusing Capacity (DLCO)(a Pulmonary Function Test)|Absolute change from Baseline in DLCO|Baseline and 16 weeks of treatment|All patients treated||mL CO/min/mm Hg||Standard Deviation|Mean
681376|NCT01557322|Other Pre-specified|Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Month 6|Health Assessment Questionnaire-Disability Index (HAQ-DI): participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0 = no difficulty; 1 = some difficulty; 2 = much difficulty; 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0 to 3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Month 6|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||units on a scale||Standard Error|Mean
681377|NCT01557322|Other Pre-specified|Change From Baseline in Disease Activity Score Based on 28-joints Count (DAS28) at Month 6|DAS28 calculated from the SJC and PJC using the 28 joints count, acute phase reactants (ESR, millimeters per hour or CRP, milligram per liter) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <2.6: remission, DAS28 <=3.2: low disease activity, DAS28 >3.2 to <=5.1: moderate disease activity, DAS28 >5.1: progression.|Baseline, Month 6|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||units on a scale||Standard Error|Mean
681378|NCT01557322|Other Pre-specified|Number of Participants Who Died or Hospitalized Due to Adverse Events|Number of participants who died or hospitalized due to AEs is reported by each follow-up time point up to Month 60.|Month 6, 12, 18, 24, 30, 36, 48, 60|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants evaluable for specified category for each treatment arm, respectively.||participants|||Number
681379|NCT01557322|Other Pre-specified|Number of Participants With Malignancy|Malignancy included lymphoproliferative tumors, Hodgkins lymphoma, myeloma, leukaemia, non-melanoma skin cancer, and solid tumor. Number of participants with each of these malignancies is reported by each follow-up time point up to Month 60.|Month 6, 12, 18, 24, 30, 36, 48, 60|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants evaluable for specified category for each treatment arm, respectively.||participants|||Number
681380|NCT01557322|Other Pre-specified|Number of Participants With Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Number of participants with AEs is reported by each follow-up time point up to Month 60.|Month 6, 12, 18, 24, 30, 36, 48, 60|Analysis population included all enrolled participants with moderate RA at baseline.||participants|||Number
681381|NCT01557322|Primary|Direct and Indirect Cost of Rheumatoid Arthritis (RA) Treatment|Direct costs included: outpatient costs, physician visits, outpatient surgery, emergency room visits, visits to healthcare professionals other than physicians, medications, diagnostic and/or therapeutic procedures, medical devices, inpatient costs, admission to acute-care nonsurgical departments, admission to acute-care surgical departments, admission to extended-care facilities, and other direct costs (travel expenses, home care, home remodeling, medical devices, non-physician healthcare professionals, alternative medicine practitioner, participant time). Indirect cost (related to lost productivity through morbidity and death) included: lost productivity in employed participants (disability, sick-leaves), lost opportunities (lost productivity in family members caring for the patient, disability requiring changes to everyday activities), and lost wages.|Baseline|Results not reported as this outcome was not evaluated due to lack of availability of information on the outcome in BSRBR used for analysis.|||||
681382|NCT01557322|Primary|Number of Rheumatoid Arthritis (RA) Related Visits|Number of RA-related visits to doctor/healthcare professional in previous 3 months was to be reported.|Baseline|Results not reported as this outcome was not evaluated due to lack of availability of information on the outcome in BSRBR used for analysis.|||||
681383|NCT01557322|Primary|Number of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 60|ACR70 response: >=70% improvement in TJC or SJC and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Month 60|Result not reported as no participants were evaluable at this time-point.|||||
681384|NCT01557322|Primary|Number of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 60|ACR50 response: >= 50% improvement in TJC or SJC and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Month 60|Result not reported as no participants were evaluable at this time-point.|||||
681385|NCT01557322|Primary|Number of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 60|ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joints count (TJC); >= 20% improvement in swollen joints count (SJC); and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Month 60|Result not reported as no participants were evaluable at this time-point.|||||
681386|NCT01557322|Primary|Change From Baseline in Pain Visual Analog Scale (VAS) Score at Month 60|The pain VAS is a horizontal line; 100 millimeter (mm) in length, self-administered by the participant to rate pain from 0 mm (no pain) to 100 mm (worst possible pain).Change = mean scores at observation minus mean scores at baseline.|Baseline, Month 60|Data not analyzed due to low number of participants available for this measure in BSRBR used for analysis.|||||
681387|NCT01557322|Primary|Time to Therapeutic Goal|Therapeutic goal achievement was based on physician’s discretion.|Baseline up to Month 60|Data not analyzed due to low number of participants available for this measure in BSRBR used for analysis.|||||
681388|NCT01557322|Primary|Time to Disease Worsening|Disease worsening (severe RA diagnosis) was defined as DAS28 score >5.1.|Baseline up to Month 60|Data not analyzed due to low number of participants available for this measure in BSRBR used for analysis.|||||
681389|NCT01557322|Primary|Change From Baseline in Euro Quality of Life - 5 Dimensions (EQ-5D) at Month 60|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Month 60|Data not analyzed due to low number of participants available for this measure in BSRBR used for analysis.|||||
681390|NCT01557322|Primary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Month 60|The 36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical component score (PCS) and mental component score (MCS). Total of 3 variables were analyzed (2 composite subscales and vitality score). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline, Month 60|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants evaluable at each time-point for each treatment arm, respectively.||units on a scale||Standard Error|Mean
681391|NCT01557322|Primary|Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Month 60|Health Assessment Questionnaire-Disability Index (HAQ-DI): participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0 = no difficulty; 1 = some difficulty; 2 = much difficulty; 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0 to 3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Month 60|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants evaluable at each time-point for each treatment arm, respectively.||units on a scale||Standard Error|Mean
681392|NCT01557322|Primary|Number of Participants With Previous and Current Disease Modifying Anti-Rheumatic Drugs (DMARDs)|Number of participants who previously received DMARDs or were currently on DMARDs at baseline is reported.|Baseline|Analysis population included all enrolled participants with moderate RA at baseline.||participants|||Number
681393|NCT01557322|Primary|Time Since Recalled Symptom Onset|RA symptoms include joint pain, stiffness, and swelling.|Baseline|Results not reported as this outcome was not evaluated due to lack availability of information on the outcome in BSRBR used for analysis.|||||
681394|NCT01557322|Primary|Time Since First Rheumatologist Visit||Baseline|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||years||Standard Error|Mean
681395|NCT01557322|Primary|Duration of Disease (Rheumatoid Arthritis)||Baseline|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||years||Standard Error|Mean
681396|NCT01557322|Primary|Change From Baseline in Patient’s Global Assessment (PtGA) of Disease Activity at Month 60|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly."|Baseline, Month 60|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants evaluable at each time-point for each treatment arm, respectively.||mm||Standard Error|Mean
681397|NCT01557322|Primary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 60|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeter/hour (mm/hr). A higher rate is consistent with inflammation.|Baseline, Month 60|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants evaluable at each time-point for each treatment arm, respectively.||mm/hour||Standard Error|Mean
681398|NCT01557322|Primary|Change From Baseline in C-Reactive Protein (CRP) Level at Month 60|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultra-sensitive assay. Normal range of CRP is <10 milligram/liter (mg/L). A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Month 60|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants evaluable at each time-point for each treatment arm, respectively.||mg/L||Standard Error|Mean
681399|NCT01557322|Primary|Change From Baseline in Swollen Joints Count (SJC) at Month 60|Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1. A negative value in change from baseline indicates an improvement.|Baseline, Month 60|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants evaluable at each time-point for each treatment arm, respectively.||swollen joints||Standard Error|Mean
681400|NCT01557322|Primary|Change From Baseline in Tender Joints Count (TJC) at Month 60|Number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1. A negative value in change from baseline indicates an improvement.|Baseline, Month 60|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants evaluable at each time-point for each treatment arm, respectively.||tender joints||Standard Error|Mean
681401|NCT01557322|Primary|Change From Baseline in Disease Activity Score Based on 28-joints Count (DAS28) at Month 60|DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, acute phase reactants (erythrocyte sedimentation rate [ESR, millimeters per hour] or C-reactive protein [CRP, milligram per liter]) and patient's global assessment (PtGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <2.6: remission, DAS28 <=3.2: low disease activity, DAS28 >3.2 to <=5.1: moderate disease activity, DAS28 >5.1: progression.|Baseline, Month 60|Analysis population included all enrolled participants with moderate RA at baseline. Here “n” signifies participants evaluable at each time-point for each treatment arm, respectively.||units on a scale||Standard Error|Mean
681402|NCT01557322|Primary|Blood Pressure (BP)|BP is the pressure of the blood within the arteries. It is produced primarily by the contraction of the heart muscle. BP measurement is recorded by 2 numbers: systolic BP (SBP, BP when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle) and diastolic BP (DBP, BP when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles).|Baseline|"Analysis population included all enrolled participants with moderate RA at baseline. Here N (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants evaluable for specified category for each treatment arm, respectively."||millimeter of mercury (mmHg)||Standard Error|Mean
681403|NCT01557322|Primary|Body Mass Index (BMI)|BMI was calculated by weight divided by height squared and measured as kilogram per square meter (kg/m^2).|Baseline|"Analysis population included all enrolled participants with moderate RA at baseline. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||kg/m^2||Standard Error|Mean
681404|NCT01557322|Primary|Number of Participants With Comorbidities|Comorbidities included: hypertension, moderate or severe heart failure, angina, stroke, epilepsy, asthma, chronic bronchitis/emphysema, peptic ulcer, tuberculosis, pre-existing or recent onset of central nervous system demyelinating disorders, chronic infectious disease such as chronic renal infection, chronic chest infection with bronchiectasis or sinusitis, active tuberculosis, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic or cerebral disease, malignancy or history of malignancy, hyperthyroidism, depression and/or anxiety, recent substance abuse (drug or alcohol), human immunodeficiency virus (HIV) infection or active hepatitis B/C infection (including associated chronic active hepatitis). Participants suffering from any of the comorbidity are reported.|Baseline|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants evaluable for specified category for each treatment arm, respectively.||participants|||Number
681405|NCT01557322|Primary|Number of Participants With Chest X-Ray Prior to New Therapy||Baseline|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||participants|||Number
681406|NCT01557322|Primary|Number of Participants With Prior Joint Replacement or Surgery|Participants who had prior total knee replacement, total hip replacement, total shoulder replacement, total elbow replacement, wrist/hand/ankle/foot surgery, and neck surgery are reported.|Baseline|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||participants|||Number
681407|NCT01557322|Primary|Number of Participants With Systemic Features|Systemic features included sicca syndrome, serosal involvement (pleurisy/pericarditis), eye involvement, systemic vasculitis, nailfold vasculitis, pulmonary fibrosis, and others (other than those specified).|Baseline|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants evaluable for specified category for each treatment arm, respectively.||participants|||Number
681408|NCT01557322|Primary|Number of Participants With American College of Rheumatology (ACR) Criteria|ACR criteria: 1) Morning stiffness: in and around joints, lasting at least (>=) 1 hour; 2) Arthritis/deformity of >=3 joint areas: presence of soft tissue swelling or fluid (not bony overgrowth alone), 14 possible areas are right/left proximal interphalangeal (PIP), metacarpophalangeal (MCP), wrist, elbow, knee, ankle, metatarsophalangeal (MTP) joints; 3) Arthritis of hand joints: >=1 area swollen in wrist, MCP, PIP joint; 4) Symmetric arthritis: simultaneous involvement of same joint areas (as defined in 2) on both sides of body; 5): Rheumatoid nodules: subcutaneous nodules over bony prominences or extensor surfaces or in juxtaarticular regions; 6): Rheumatoid factor (RF): abnormal amounts of RF by any method for which result has been positive in <5% of normal control participants; 7) Radiographic changes: typical of RA on posteroanterior hand and wrist radiographs, which must include erosions/unequivocal bony decalcification localized in or most marked adjacent to involved joints.|Baseline|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||participants|||Number
681409|NCT01557283|Other Pre-specified|Number of Participants Who Received Intermittent Treatment|Number of participants who received etanercept treatment in cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation was reported.|Baseline up to end of study (90 weeks)|Per protocol (PP) population included participants who completed at least 1 treatment cycle, for whom study conclusion was duly filled in, and who had not deviated from protocol. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.||participants|||Number
681410|NCT01557283|Other Pre-specified|Number of Participants Who Received Continuous Treatment|Number of participants who were treated continuously with etanercept without any treatment discontinuation as per dermatologist’s discretion was reported.|Baseline up to end of study (90 weeks)|Per protocol (PP) population included participants who completed at least 1 treatment cycle, for whom study conclusion was duly filled in, and who had not deviated from protocol. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.||participants|||Number
681411|NCT01557283|Secondary|Number of Participants With Reasons for Treatmant Discontinuation|Number of participants who discontinued etanercept before completing the study was reported.|Baseline up to end of study (90 weeks)|Per protocol (PP) population included participants who completed at least 1 treatment cycle, for whom study conclusion was duly filled in, and who had not deviated from protocol.||participants|||Number
681412|NCT01557283|Secondary|Percentage of Body Surface Area (BSA) Affected by Psoriasis|Percentage of body surface area affected by psoriasis was estimated using the palm method: one of the participant’s palm to proximal interphalangeal and thumb = 1 percent (%) of total BSA. Regions of the body were assigned specific number of palms with percentage [Head and neck = 10% (10 palms), upper extremities = 20% (20 palms), Trunk (axillae and groin) = 30% (30 palms), lower extremities (buttocks) = 40% (40 palms)]. The total BSA affected was the summation of individual regions affected.|Start and end of cycle 1, 2, 3|Per protocol (PP) population included participants who completed at least 1 treatment cycle, for whom study conclusion was duly filled in, and who had not deviated from protocol. 'N' (number of participants analyzed) signifies participants evaluable for this measure; ‘n’ signifies participants evaluable for this measure at specified time points.||percentage of BSA||Standard Deviation|Mean
681413|NCT01557283|Secondary|Psoriasis Area and Severity Index (PASI) Score|Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, and legs. For each section, percent (%) area of skin involved was estimated: 0 = 0%, 1 = less than (<) 10%, 2 = 10 to <30%, 3 = 30 to <50%, 4 = 50 to <70%, 5= 70 to <90%, 6 = 90 to 100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0 = none to 4 = maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease.|Start and end of cycle 1, 2, 3|Per protocol (PP) population included participants who completed at least 1 treatment cycle, for whom study conclusion was duly filled in, and who had not deviated from protocol. 'N' (number of participants analyzed) signifies participants evaluable for this measure; ‘n’ signifies participants evaluable for this measure at specified time points.||units on a scale||Standard Deviation|Mean
681414|NCT01557283|Secondary|Number of Weeks of Off-Treatment|Total duration of time in weeks for which participants discontinued etanercept treatment was reported.|Baseline up to end of study (90 weeks)|Per protocol (PP) population included participants who completed at least 1 treatment cycle, for whom study conclusion was duly filled in, and who had not deviated from protocol. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.||weeks||Standard Deviation|Mean
681415|NCT01557283|Primary|Number of Weeks of Etanercept Treatment|Average duration of time in weeks for treatment with etanercept was reported.|Baseline up to end of study (90 weeks)|Per protocol (PP) population included participants who completed at least 1 treatment cycle, for whom study conclusion was duly filled in, and who had not deviated from protocol.||weeks||Standard Deviation|Mean
681420|NCT01556997|Secondary|Change From Baseline to End of Treatment in the Mean Seated Trough Cuff Systolic Blood Pressure (SBP).||Day 0 to Day 42|The Analysis Population for the Secondary Outcome (Change from baseline to end of treatment in the mean seated trough cuff systolic blood pressure (SBP)) consists of the Intent-to-treat population for the study||mmHg||Standard Deviation|Mean
681421|NCT01556997|Primary|Change From Baseline to End of Treatment in the Mean Seated Trough Cuff Diastolic Blood Pressure (DBP).||Day 0 to Day 42|The Analysis Population for the Primary Outcome (Change from baseline to end of treatment in the mean seated trough cuff diastolic blood pressure (DBP)) consists of the Intent-to-treat population for the study||mmHg||Standard Deviation|Mean
681422|NCT01556932|Primary|The Change in Numeric Rating Scale in Self-reported Nausea From Baseline Minus 60 Minutes of Treatment.|The outcome measure for change was calculated from value at baseline minus value at 60 minutes. Subjects were asked to rate their nausea on a 0 (no nausea) to 10 (worst possible nausea) scale. Subjects who were eligible were randomly assigned to two sequences: one sequence used ABH gel first and then placebo; and the other sequence used placebo first and then ABH gel. We assumed that there was no carry-over effect from the first treatment to the second. A paired t-test was used to compare if ABH gel is not better than the placebo gel. A repeated measure analysis was used to compare the two treatment sequences. This endpoint was chosen as the drug gel because it is typically used as a “prn” (as needed) gel in actual practice, when relief is needed in short order.|60 minutes after application|25 participants were consented, two subjects declined treatment, one expired subject. Two subjects refused to continue after first treatment and did not complete the second treatment. Only 20 patients were analyzed because of missing data not done by those two subjects on the second treatment.||units on a scale||Standard Deviation|Mean
681423|NCT01556906|Secondary|Absolute Change From Baseline in Linoleic Acid (LA)|Absolute Change From Baseline in LA|Baseline and 16 weeks of treatment|All patients treated||mg/mL||Standard Deviation|Mean
681424|NCT01556906|Secondary|Absolute Change From Baseline in Docosahexaenoic Acid (DHA)|Absolute Change From Baseline in DHA|Baseline and 16 weeks of treatment|All patients treated||mg/mL||Standard Deviation|Mean
681425|NCT01556906|Secondary|Absolute Change From Baseline in Eicosapentaenoic Acid (EPA)|Absolute Change From Baseline in EPA|Baseline and 16 weeks of treatment|All patients treated||mg/mL||Standard Deviation|Mean
681426|NCT01556906|Secondary|Absolute Change From Baseline in Alpha Linoleic Acid (ALA)|Absolute Change From Baseline in ALA|Baseline and 16 weeks of treatment|All patients treated||mg/mL||Standard Deviation|Mean
681438|NCT01556763|Secondary|P300 Peak Amplitude|P300 auditory evoked potential response (amplitude in microvolts) using orienting paradigm. Measured by EEG and calculated as the peak amplitude over 250-500 msec following stimulus onset (rare stimulus minus frequent stimulus). Plotted on a scale of -0.4 to 1.2 microvolts. Normalization is suggested by a more positive value.|Days -1 to 20|Subjects providing valid and measurable P300 responses.||microvolts||Standard Error|Mean
681439|NCT01556763|Secondary|MMN Summed Amplitude|Mismatch negativity (MMN) auditory evoked potential response (amplitude in microvolts) using orienting paradigm. Measured by EEG and calculated as the voltage difference over 100-200 msec following stimulus onset (rare stimulus minus frequent stimulus). Plotted on a scale of -1.2 to 0.2 microvolts. Normalization is suggested by a more negative value.|Days -1 to 20|Subjects providing valid and measurable MMN responses.||microvolts||Standard Error|Mean
681440|NCT01556763|Secondary|P50 Amplitude Difference|P50 auditory evoked potential response (amplitude measured in microvolts) using sensory gating paradigm. Measured by EEG as amplitude difference (conditioning stimulus minus test stimulus). Plotted on a scale of -0.2 to 0.8 microvolts. Normalization is suggested by a higher value.|Days -1 to 20|Subjects providing valid and measurable P50 responses.||microvolts||Standard Error|Mean
681441|NCT01556763|Secondary|N100 Gating Ratio|N100 auditory evoked potential response (amplitude measured in microvolts) using the sensory gating paradigm. Measured by electroencephalography (EEG) as the amplitude ratio of test stimulus to conditioning stimulus. Plotted on a unitless scale of 0 to 2. Normalization is suggested by a lower value.|Days -1 to 20|Subjects providing valid and measurable N100 responses.||ratio||Standard Error|Mean
681442|NCT01556763|Primary|EVP-6124 Half-life (T[1/2]), Patients on Paliperidone/Risperidone|Blood samples for PK analyses were taken before dosing with EVP-6124 on Days 1 and 21.|Days 1 and 21|Patients receiving paliperidone/risperidone for whom blood samples were available for analysis.||hr||Standard Deviation|Mean
681443|NCT01556763|Primary|EVP-6124 Area Under the Curve (AUC[0-24 h]), Patients on Paliperidone/Risperidone|Blood samples for PK analyses were taken before dosing with EVP-6124 on Days 1 and 21.|Days 1 and 21|All patients receiving paliperidone/risperidone.||pg*hr/ml||Standard Deviation|Mean
681444|NCT01556763|Primary|EVP-6124 Time to Maximum Concentration (Tmax), Patients on Paliperidone/Risperidone|Blood samples for PK analyses were taken before dosing with EVP-6124 on Days 1 and 21.|Days 1 and 21|All patients receiving paliperidone/risperidone.||hr||Full Range|Median
681445|NCT01556763|Primary|EVP-6124 Maximum Plasma Concentration (Cmax), Patients on Paliperidone/Risperidone|Blood samples for PK analyses were taken before dosing with EVP-6124 on Days 1 and 21.|Days 1 and 21|All patients receiving paliperidone/risperidone.||pg/mL||Standard Deviation|Mean
681446|NCT01556763|Primary|EVP-6124 Half-life (T[1/2]), Patients on Aripiprazole|Blood samples for PK analyses were taken before dosing with EVP-6124 on Days 1 and 21.|Days 1 and 21|Patients receiving aripiprazole for whom blood samples were available for analysis.||hr||Standard Deviation|Mean
681447|NCT01556763|Primary|EVP-6124 Area Under the Curve (AUC[0-24 h]), Patients on Aripiprazole|Blood samples for PK analyses were taken before dosing with EVP-6124 on Days 1 and 21.|Days 1 and 21|All patients receiving aripiprazole.||pg*hr/mL||Standard Deviation|Mean
681448|NCT01556763|Primary|EVP-6124 Time to Maximum Concentration (Tmax), Patients on Aripiprazole|Blood samples for PK analyses were taken before dosing with EVP-6124 on Days 1 and 21.|Days 1 and 21|All patients receiving aripiprazole.||hr||Full Range|Median
681449|NCT01556763|Primary|EVP-6124 Maximum Plasma Concentration (Cmax), Patients on Aripiprazole|Blood samples for pharmacokinetic (PK) analyses were taken before dosing with EVP-6124 on Days 1 and 21.|Days 1 and 21|All patients receiving aripiprazole.||pg/mL||Standard Deviation|Mean
681450|NCT01556763|Primary|Number of Participants With Serious and Non-serious Adverse Events Spontaneously Reported by Subject and/or Observed by Investigator.|Safety and tolerability was measured by number of reported adverse events (serious and non-serious) and repeated clinical evaluation of physical examinations, vital signs, 12-lead electrocardiogram (ECG), 24-hour continuous cardiac monitoring, and laboratory tests (hematology/blood chemistry/urinalysis).|Screening (Day -5 for continuous cardiac monitoring) to Day 22|All randomized patients who ingested at least one dose of study drug or placebo.||participants|||Number
681451|NCT01556724|Secondary|Decreased Infusion Rates|Number of patient requiring decreased infusion rates due to increased motor blockade|Subjects will be followed postoperatively until postoperative day 2 (i.e. the discontinuation of the lumbar plexus catheters)||||||
681452|NCT01556724|Secondary|Increased Infusion Rates|Number of patients requiring increased infusion rates to better optimize pain control|Subjects will be followed postoperatively until postoperative day 2 (i.e. the discontinuation of the lumbar plexus catheters)||||||
681453|NCT01556724|Secondary|NRS Pain Score|Pain scores (VAS; at rest and with physical therapy; 0-10) at 24 hours postoperative|24 hours postoperatively||||||
681454|NCT01556724|Secondary|Patient Satisfaction With Pain Control|Patient satisfaction with pain control at 24 hours (0-10 scale)|24 hours postoperatively||||||
681455|NCT01556724|Primary|Opiate Consumption Postoperatively|Postoperative opiate consumption at 24 hours|24 hours postoperatively|||mg||95% Confidence Interval|Mean
681456|NCT01556633|Secondary|Number of Participants With Abnormal Shifts in Vital Signs|"Vital signs included pulse rate, systolic blood pressure (SBP), diastolic blood pressure (DBP), and body temperature.
Vital sign with abnormal shifts from normal at baseline to high or low at post-baseline time points were recorded. Blood pressure was recorded in millimeter of mercury (mmHg), and temperature in degrees Celsius. Low blood pressure defined as <=70 mmHg (SBP) and <=40 mmHg (DBP); high blood pressure defined as >=140 mmHg (SBP) and >=90 mmHg (DBP); low temperature defined as <=36.5 degrees Celsius and high temperature defined as >=37.5 degrees Celsius."|Days 1 (post-dose), 2, 3, 4, 5, 6, 7, 8; and Follow-up visit (Days 15 to 22)|Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.||participants|||Number
681457|NCT01556633|Secondary|Number of Participants With Change From Baseline in Marked Abnormality in Electrocardiogram (ECG) Parameters at Follow-up Visit|ECG parameter included QT interval, QTcB interval and QTcF interval (all intervals are measured in millisecond [msec]). Marked abnormality in ECG is predefined for QT, QTcB, and QTcF interval as <=30, >30-60, and >60 msec increase from baseline.|From Baseline (Day -1) to Follow-up visit (Days 15 to 22)|Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.||participants|||Number
681458|NCT01556633|Secondary|Number of Participants With Marked Abnormality in Laboratory Measurements|"Laboratory analysis included: hematology (hemoglobin, hematocrit, reticulocyte, red blood cell, platelet and white blood cell count, mean corpuscular volume, mean corpuscular hemoglobin), prothrombin and activated partial thromboplastin time, biochemistry (sodium, potassium, bicarbonate, phosphate, chloride, calcium, urea, serum creatinine, bilirubin, cholesterol, alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase [ALT], gamma-glutamyl transferase, protein, albumin, amylase, creatinine, lipase), random glucose, and urinalysis.
Laboratory test result values falling outside of the marked abnormality range that also represent a defined change from baseline were considered as marked laboratory abnormalities. A marked reference range for sodium is 130-150 millimole (mmol)/L, chloride is 95-115 mmol/L, phosphate is 0.75-1.60 mmol/L, calcium is 2-2.90 mmol/L, glucose is 2.8-11.10 mmol/L, bicarbonate is 18-28 mmol/L, and ALT is 0-110 Unit/L."|Approximately 7 weeks|Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.||participants|||Number
681459|NCT01556633|Primary|Renal Clearance (CLR) of Oseltamivir and Oseltamivir Carboxylate|CLR is calculated as the cumulative amount of drug excreted into urine from 0 to time t hours (Ae0-tlast) / area under the concentration-time curve from time zero through the last quantifiable concentration time (AUC0-t).|Pre-dose; 0.5, 1.33, 2, 2.5, 3, 4, 5, 6.67, 8, 10, 12, 14, 16, 20, 24, 28, 32, 48, 72, 96, 120, 144, and 168 hrs post-dose for blood; pre-dose and 0-24, 24-48, 48-72, 72-96, 96-120, 120-144, and 144-168 hrs post-dose for urine.|"PK population was used for this outcome measure. Only 9 participants were included, who did not significantly violate the inclusion/exclusion criteria, deviate significantly from protocol or with unavailable or incomplete data which influence PK analysis. Numbers of participants analyzed for the indicated drug/metabolite were denoted by n."||L/h||Geometric Coefficient of Variation|Geometric Mean
681460|NCT01556633|Primary|Tmax and T1/2 of Oseltamivir and Oseltamivir Carboxylate|"The Time of observed maximum plasma concentration (Tmax) is defined as actual sampling time to reach maximum observed analyte concentration.
The Elimination Half-Life Period (T1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. Oseltamivir carboxylate is a clinically active metabolite of oseltamivir."|Pre-dose; 0.5, 1.33, 2, 2.5, 3, 4, 5, 6.67, 8, 10, 12, 14, 16, 20, 24, 28, 32, 48, 72, 96, 120, 144, and 168 hrs post-dose|"PK population was used for this outcome measure. Only 9 participants were included, who did not significantly violate the inclusion/exclusion criteria, deviate significantly from protocol or with unavailable or incomplete data which influence PK analysis. Numbers of participants analyzed for the indicated drug/metabolite were denoted by n."||h||Full Range|Median
681461|NCT01556633|Primary|C120h, C168h and Clast of Oseltamivir and Oseltamivir Carboxylate for 75 mg Dose|"C120h is defined as the plasma concentration at 120 hours post-dose. C168h is defined as the plasma concentration at 168 hours post-dose. Clast is defined as the plasma concentration corresponding to the time of the last measureable (positive) plasma concentration.
Oseltamivir carboxylate is a clinically active metabolite of oseltamivir."|Pre-dose; 0.5, 1.33, 2, 2.5, 3, 4, 5, 6.67, 8, 10, 12, 14, 16, 20, 24, 28, 32, 48, 72, 96, 120, 144, and 168 hrs post-dose|PK population was used for this outcome measure. Only 9 participants were included, who did not significantly violate the inclusion/exclusion criteria, deviate significantly from protocol or with unavailable or incomplete data which influence PK analysis.||ng/mL||Standard Deviation|Mean
681462|NCT01556633|Primary|Cmax of Oseltamivir and Oseltamivir Carboxylate|The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration. Oseltamivir carboxylate is a clinically active metabolite of oseltamivir.|Pre-dose; 0.5, 1.33, 2, 2.5, 3, 4, 5, 6.67, 8, 10, 12, 14, 16, 20, 24, 28, 32, 48, 72, 96, 120, 144, and 168 hrs post-dose|"PK population was used for this outcome measure. Only 9 participants were included, who did not significantly violate the inclusion/exclusion criteria, deviate significantly from protocol or with unavailable or incomplete data which influence PK analysis. Numbers of participants analyzed for the indicated drug/metabolite were denoted by n."||ng/mL||Geometric Coefficient of Variation|Geometric Mean
681463|NCT01556633|Primary|AUCinf of Oseltamivir and Oseltamivir Carboxylate for 30 mg Dose|AUCinf is defined as the area under the plasma concentration-time curve from time zero extrapolated to infinity. Oseltamivir carboxylate is a clinically active metabolite of oseltamivir.|Pre-dose; 0.5, 1.33, 2, 2.5, 3, 4, 5, 6.67, 8, 10, 12, 14, 16, 20, 24, 28, 32, 48, 72, 96, 120, 144, and 168 hrs post-dose|"PK population was used for this outcome measure. Only 9 participants were included, who did not significantly violate the inclusion/exclusion criteria, deviate significantly from protocol or with unavailable or incomplete data which influence PK analysis. Numbers of participants analyzed for the indicated drug/metabolite were denoted by n."||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
681464|NCT01556633|Primary|AUC120, AUC168 and AUCinf of Oseltamivir and Oseltamivir Carboxylate for 75 mg Dose|AUC120 is defined as the area under the plasma concentration-time curve from time zero through 120 hours post-dose, AUC168 is defined as the area under the plasma concentration-time curve from time zero through 168 hours post-dose, and AUCinf is defined as the area under the plasma concentration-time curve from time zero extrapolated to infinity. Oseltamivir carboxylate is a clinically active metabolite of oseltamivir.|Pre-dose; 0.5, 1.33, 2, 2.5, 3, 4, 5, 6.67, 8, 10, 12, 14, 16, 20, 24, 28, 32, 48, 72, 96, 120, 144, and 168 hrs post-dose|"PK population was used for this outcome measure. Only 9 participants were included, who did not significantly violate the inclusion/exclusion criteria, deviate significantly from protocol or with unavailable or incomplete data which influence PK analysis. Numbers of participants analyzed for the indicated drug/metabolite were denoted by n."||nanogram (ng)*h/ milliliter (mL)||Geometric Coefficient of Variation|Geometric Mean
681465|NCT01556633|Secondary|Number of Participants With Any Adverse Event (AEs) and Any Serious Adverse Events (SAEs)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with the intervention. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.|Approximately 7 weeks|Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.||participants|||Number
681629|NCT01553292|Secondary|Needs for Intubation During the Procedure|The needed for interruption or stop of ECALMIST to give PPV (positive pressure ventilation or mechanical ventilation though intubation by ETT (endotracheal intubation)|10 minutes|The number of preterm infants that needed intubation by ETT (endotracheal intubation) during ECALMIST||Number of participants|||Number
681466|NCT01556633|Primary|Total Dialysate Clearance for Automated Peritoneal Dialysis (CLDAPD) of Oseltamivir and Oseltamivir Carboxylate for 75 mg Dose|"CLDAPD is the total dialysate clearance for automated peritoneal dialysis, attributable to both continuous cycler-assisted peritoneal dialysis (CCPD) and continuous ambulatory peritoneal dialysis (CAPD), which was calculated with the recovery method over the dense blood sampling collection interval from 0 to 48 hours post-dose.
CLDAPD = the amount excreted into dialysate from 0 to 48 hours (Aed[0-48])/ plasma area under the concentration-time curve from time zero through 48 hours (AUC[0-48])
CLDCCPD = mean of CLDCCPD from the 2 CCPD sessions, calculated as CLDCCPD = (Aed[0-8]/AUC[0-8] + Aed[24-32]/AUC[24-32]) / 2
CLDCAPD = mean of CLDCAPD from the 3 CAPD sessions, calculated as CLDCAPD = (Aed[8-16]/AUC[8-16] + Aed[16-24]/AUC[16-24] + Aed[32-48]/AUC[32-48]) / 3"|CCPD: pre-dose (0)-2.67, 2.67-5.33, 5.33-8; CAPD: 8-16, 16-24; CCPD: 24-26.67, 26.67-29.33, 29.33-32; CAPD: 32-40, 40-48 hrs post-dose for urine; CCPD and CAPD:0.5, 1.33, 2, 2.5, 3, 4, 5, 6.67, 8, 10, 12, 14, 16, 20, 24, 28, 32, 48 hrs post-dose for blood|Pharmacokinetic (PK) population: Only 9 participants were included for this analysis as they did not significantly violate the inclusion or exclusion criteria, deviate significantly from the protocol or if data was unavailable or incomplete which influence the PK analysis were excluded from the PK analysis population.||Litre (L)/hour (h)||Geometric Coefficient of Variation|Geometric Mean
681467|NCT01556594|Secondary|Mean Peak Plasma Concentration (Cmax) of Glucose|mean plasma glucose level after treatment with test article|Samples were obtained at 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administration|All subjects treated were analyzed||mmol/L||Standard Error|Mean
681468|NCT01556594|Primary|Participants With at Least One Adverse Event|Safety and tolerability will be evaluated through the assessment of adverse events, physical examination, laboratory tests, vital signs and ECG.|Safety evaluations were recorded from dosing up until 3 hours after dosing with test medication|All patients who were treated were included in the analysis||participants with at least one AE|||Number
681469|NCT01556594|Primary|Percentage of Responders|A responder will be defined as a subject who achieved normal blood glucose ( ≥3.8 mmol/L) within 30 minutes after treatment.|Within 30 minutes of treatment with test article|All subjects were included in the analysis||percentage of patients treated|||Number
681470|NCT01556451|Primary|Percentage of Participants Discontinued Due to Clinical Adverse Experiences||Up to 42 days postvaccination|Safety population which included all vaccinated participants who had any safety follow-up||Percentage of Participants|||Number
681471|NCT01556451|Primary|Percentage of Participants With Clinical Adverse Experiences|An adverse experience was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse experience.|Up to 42 days postvaccination|Safety population which included all vaccinated participants who had any safety follow-up||Percentage of Participants|||Number
681472|NCT01556451|Primary|Geometric Mean Titer (GMT) of VZV Antibody|Blood samples collected prevaccination on Day 1 and Week 4 postvaccination were analyzed using a gpELISA to detect Immunoglobulin G antibody to VZV|Day 1 (Baseline) and 4 weeks postvaccination|The population analyzed included all participants who received Zoster Vaccine Live and were not excluded at the request of the Institutional Review Board and did not have major deviations from the protocol procedures||gpELISA units/mL||95% Confidence Interval|Geometric Mean
681473|NCT01556451|Primary|Geometric Mean Fold Rise (GMFR) From Day 1 in Varicella Zoster Virus (VZV) Antibody|Blood samples collected prevaccination on Day 1 and Week 4 postvaccination were analyzed using a glycoprotein enzyme-linked immunosorbent assay (gpELISA) to detect Immunoglobulin G antibody to VZV. The GMFR reports the geometric mean of the ratio of individual participant VZV antibody titers at Week 4 postvaccination / Day 1 (Baseline).|Day 1 (Baseline) and Week 4 postvaccination|The population analyzed included all participants who received Zoster Vaccine Live and were not excluded at the request of the Institutional Review Board and did not have major deviations from the protocol procedures||Ratio||95% Confidence Interval|Geometric Mean
681474|NCT01556204|Secondary|Pain|Pain as estimated by endometriosis, Endometriosis Health Profile-30 (EHP-30). Score ranges from 0-100. Lower score denotes improvement. Pain: As score decreases, pain decreases. No subscales.|Baseline, 6-weeks, 6-months|||units on a scale||Standard Deviation|Mean
681475|NCT01556204|Primary|Operative Time|Operative time is defined as skin incision to skin closure.|1st 24 hours|||minutes||Standard Deviation|Mean
681476|NCT01556165|Secondary|Levodopa Administration Within 26 Weeks|It was stated in the statistical analysis plan (SAP) that if >10% of FAS patients were considered to have taken levodopa during the treatment period, the endpoint, levodopa administration within 26 Weeks was to be analysed. However, since only one patient (in the placebo group) had levodopa administered during the treatment period, this endpoint was not analysed, as had been defined a priori in the SAP.|Baseline to Week 26||||||
681477|NCT01556165|Secondary|Time to Onset of Levodopa Therapy|It was stated in the statistical analysis plan (SAP) that if >10% of FAS patients were considered to have taken levodopa during the treatment period, the endpoint, time to onset of levodopa treatment was to be analysed. However, since only one patient (in the placebo group) had levodopa administered during the treatment period, this endpoint was not analysed, as had been defined a priori in the SAP.|Baseline to Week 26||||||
681478|NCT01556165|Secondary|Change From Baseline to Week 26 in Subscale Scores of the UPDRS (Part III)|The Unified Parkinson's Disease Rating Scale (UPDRS) Part III evaluates motor function, it comprises 14 parts and the score ranges from 0 (normal) to 108 (severe impairement and disability)|Baseline to Week 26|The full-analysis set (FAS) comprised all patients in the APTS who had a valid baseline assessment and at least one valid post-baseline assessment of the primary efficacy variable.||units on a scale||Standard Error|Mean
681479|NCT01556165|Secondary|Change From Baseline to Week 26 in Subscale Scores of the UPDRS (Part II)|The Unified Parkinson's Disease Rating Scale (UPDRS) Part II evaluates activities of daily living, it comprises 13 parts and the score ranges from 0 (normal) to 52 (severe impairement and disability)|Baseline to Week 26|The full-analysis set (FAS) comprised all patients in the APTS who had a valid baseline assessment and at least one valid post-baseline assessment of the primary efficacy variable.||units on a scale||Standard Error|Mean
682599|NCT01539512|Secondary|Complete Response Rate|Complete response rate was defined as the percentage of participants who achieved a complete response.|Up to 17 months|ITT Analysis Set: randomized participants with treatment group designated according to initial randomization.||percentage of participants|||Number
681480|NCT01556165|Secondary|Change From Baseline to Week 26 in Subscale Scores of the UPDRS (Part I)|The Unified Parkinson's Disease Rating Scale (UPDRS) Part I evaluates mentation, behaviour and mood symptoms, it comprises 4 parts and the score ranges from 0 (normal) to 16 (severe impairement)|Baseline to Week 26|The full-analysis set (FAS) comprised all patients in the APTS who had a valid baseline assessment and at least one valid post-baseline assessment of the primary efficacy variable.||units on a scale||Standard Error|Mean
681481|NCT01556165|Primary|Change From Baseline to Week 26 in UPDRS Total Score|The Unified Parkinson's Disease Rating Scale (UPDRS) is a 42-item rating scale designed to assess Parkinson’s disease-related disability and impairment. The scale comprises four parts: Part I evaluates mentation, behaviour, and mood symptoms; Part II evaluates activities of daily living (ADL); Part III evaluates motor function; and Part IV evaluates complications of dopaminergic therapy. The total score is the sum of the subscale scores for Parts I to III and ranges from 0 (no disability) to 176 (total dependence).|Baseline to Week 26|The full-analysis set (FAS) comprised all patients in the APTS who had a valid baseline assessment and at least one valid post-baseline assessment of the primary efficacy variable.||units on a scale||Standard Error|Mean
681482|NCT01556061|Secondary|Second Laryngoscopy|A second laryngoscopy will be performed in patients with the video laryngoscope from the other group. Patients will be intubated after second laryngoscopy with with this same video laryngoscope.|30 seconds|||seconds||Inter-Quartile Range|Median
681483|NCT01556061|Secondary|First Laryngoscopy|Patients underwent laryngoscopy first with their assigned randomized laryngoscope. Time measured was from the time from the moment the anesthesiologist had the laryngoscope in hand to time to optimal visualization of vocal cords.|30 seconds|||seconds||Inter-Quartile Range|Median
681484|NCT01556061|Primary|Time for Intubation|Time taken for successful placement of endotracheal tube after a successful laryngoscopy. Typically a successful laryngoscopy will range from few seconds to no more than 90 seconds. A successful intubation will not range more than 90 seconds.|90 seconds|The unit of measure of time in seconds from D-MAC larynogoscopy to intubation in the (C-MAC Laryngoscopy First, Then DMAC Video Laryngoscopy) group and from C-MAC laryngoscopy to intubation in the (D-MAC Laryngoscopy First, Then C-MAC Video Laryngoscopy) group.||seconds||Inter-Quartile Range|Median
681485|NCT01555983|Primary|Number of Participants Achieving a Reduction in Pain Intensity of 30% or More|Number of participants achieving a reduction of pain intensity of 30% or more, a level believed to be clinically important, was estimated for each treatment dose.|hourly pain assessments for 8 hours|||participants|||Number
681486|NCT01555931|Secondary|LNG-IUS Expulsion or Removal|Expulsion or indicated removal of the originally placed LNG-IUS at any point during the study|up to 6 months|||participants|||Number
681487|NCT01555931|Primary|Breastfeeding|Reported any breastfeeding at the final 6 month visit|6 months|||participants|||Number
681488|NCT01555567|Secondary|Central Activation Ratio|CAR = maximal voluntary isometric contractions force / maximal voluntary isometric contractions force + stimulated force|Time of return to activity (~6 months following surgery)|||ratio||Standard Deviation|Mean
681489|NCT01555567|Primary|Quadriceps Strength||Time of return to activity (~6 months following surgery)|||Nm/kg||Standard Deviation|Mean
681490|NCT01555463|Secondary|Change From Baseline in Index Value at End of Treatment|The EuroQol Group Questionnaire–5 Dimensions–5 Levels (EQ-5D-5L) is a standardized instrument for use as a measure of health outcome. Applicable to a wide range of health conditions and treatments, it provides a simple descriptive profile and a single index value for health status. It is used to assess the level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension is evaluated using 5 levels: “no problems” (level 1), “slight problems” (level 2), “moderate problems” (level 3), “severe problems” (level 4), and “extreme problems” (level 5). A scoring formula developed by EuroQol Group calculates a single index value from the results from all 5 domains along a continuum of 0 (death) to 1 (full health). The median (range) change, defined as the index value at end of treatment minus the index value at baseline, is presented.|Baseline and end of treatment, up to 12 weeks|All subjects who were randomized, were dispensed any study medication and had a non-missing observation at end of treatment.||Scores on a scale||Full Range|Median
681491|NCT01555463|Secondary|Change From Baseline in EuroQol Group Questionnaire-Visual Analogue Scale (EQ-VAS) at End of Treatment|"The EuroQol Group Questionnaire-Visual Analogue Scale (EQ-VAS) is a standardized instrument for use as a measure of health outcome. The EQ-VAS asks for a judgment of the overall health status assessed by the participant her/himself. The 20-cm visual analog scale (VAS) has endpoints labeled best imaginable health state and worst imaginable health state that are anchored at 100 and 0, respectively. Respondents are asked to indicate how they rate their own health by drawing a line from an anchor box to that point on the EQ-VAS, which best represents their own health on that day; higher scores indicate a better health state. The median (range) of the change, defined as EQ-VAS at end of treatment minus EQ-VAS at baseline, is presented."|Baseline and end of treatment, up to 12 weeks|All subjects who were randomized, were dispensed any study medication and had a non-missing observation at end of treatment.||Scores on a scale||Full Range|Median
681492|NCT01555463|Secondary|Number of Participants With Change From Baseline in Dermatology Life Quality Index (DLQI) Questionnaire at End of Treatment - Overall Score|The Dermatology Life Quality Index (DLQI) is a questionnaire consisting of a set of 10 questions that evaluate the degree to which the participant’s skin has affected certain behaviors and quality of life over the past week. Possible responses to each question are: “very much” (question 7: “yes”) (score=3), “a lot” (score=2), “a little” (score=1), or “not at all”/”not relevant” (score=0). The DLQI overall score is the sum of the results from all 10 questions, with possible scores ranging from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. The number of participants with score changes (end of treatment – baseline) in DLQI overall score from baseline to end of treatment <=-5 and >-5 are presented.|Baseline and end of treatment, up to 12 weeks|All subjects who were randomized, were dispensed any study medication and had a non-missing observation at end of treatment.||Participants|||Number
681630|NCT01553292|Secondary|Oxygen Requirements After the Procedure|Oxygen requirement is expressed as proportion out of one (decimal) which is equal to percentage of 100. The measurment can be any where between 0.21 to 1 and this equal to percentage of 21-100%.|4 hours|The mean of oxygen level (proportion) of all participant after ECALMIST||Proportion of oxygen saturation||Standard Deviation|Mean
681493|NCT01555463|Secondary|Change From Baseline in Rosacea Quality of Life (RosaQoL) Questionnaire at End of Treatment - Overall Quality of Life Score|The Rosacea Quality of Life (RosaQoL) is a questionnaire to evaluate the effect of rosacea on a participant’s quality of life. Each of the 21 items in this questionnaire asks about the frequency with which a particular aspect of living with rosacea affects the participant: possible responses for each item are “never” (score=1), “rarely” (score=2), “sometimes” (score=3), “often” (score=4), or “all the time” (score=5). The overall score is the sum of the results from all 21 questions, with possible scores ranging from 21 (best) to 105 (worst); the higher the score, the more quality of life is impaired. The mean (standard deviation) of the change, defined as end of treatment overall score minus baseline overall score, is presented.|Baseline and end of treatment, up to 12 weeks|All subjects who were randomized, were dispensed any study medication and had a non-missing observation at end of treatment.||Scores on a scale||Standard Deviation|Mean
681494|NCT01555463|Secondary|Participants' Opinion on Practicability of Product Use in Facial Areas Next to the Hairline at End of Treatment|At the end of treatment, participants provided their opinion on the practicability of the use of the investigational product in facial areas next to the hairline as very good, good, satisfactory, poor, or no opinion. The number of participants in each category of this assessment is presented.|At end of treatment, up to 12 weeks|All subjects who were randomized, were dispensed any study medication and had a non-missing observation at end of treatment.||Participants|||Number
681495|NCT01555463|Secondary|Participants' Opinion on Cosmetic Acceptability at End of Treatment|At the end of treatment, participants provided their opinion on cosmetic acceptability of the investigational product as very good, good, satisfactory, poor, or no opinion. The number of participants in each category of this assessment is presented.|At end of treatment, up to 12 weeks|All subjects who were randomized, were dispensed any study medication and had a non-missing observation at end of treatment.||Participants|||Number
681496|NCT01555463|Secondary|Participants' Global Assessment of Tolerability at End of Treatment|At the end of treatment, participants provided their opinion on local tolerability of the investigational product as excellent, good, acceptable despite minor irritation, less acceptable due to continuous irritation, non-acceptable, or no opinion. The number of participants in each category of this assessment is presented.|At end of treatment, up to 12 weeks|All subjects who were randomized, were dispensed any study medication and had a non-missing observation at end of treatment.||Participants|||Number
681497|NCT01555463|Secondary|Participants' Global Assessment of Treatment Response at End of Treatment|At the end of treatment, participants assessed the change of papulopustular rosacea from baseline (how it looked, felt, appeared to others) as excellent improvement, good improvement, fair improvement, no improvement, or worse. The number of participants in each category of this assessment is presented.|At end of treatment, up to 12 weeks|All subjects who were randomized, were dispensed any study medication and had a non-missing observation at end of treatment.||Participants|||Number
681498|NCT01555463|Secondary|Percentage of Participants With Facial Skin Color Rating at End of Treatment (LOCF)|Facial skin color (as compared with skin outside the treatment area) was rated as: normal; barely visible skin lightening; mild skin lightening; moderate skin lightening; severe skin lightening. The percentage of participants in each category of facial skin color at the end of study is presented.|At end of treatment (LOCF), up to 12 weeks|All subjects who were randomized and who were dispensed any study medication. For subjects with missing end of treatment observation the last non-missing observation was carried forward, including baseline.||Percentage of participants|||Number
681499|NCT01555463|Secondary|Grouped Changes From Baseline in Telangiectasia Intensity Score at End of Treatment (LOCF)|Telangiectasia was rated as: no; mild; moderate; or severe. At the end of study, a participant was considered to have an ‘improved’ telangiectasia rating if the telangiectasia rating was lower compared to the baseline rating, ‘no change’ if the rating was identical, and ‘worsened’ if the rating was higher. The percentage of participants in each category is presented.|Baseline and end of treatment (LOCF), up to 12 weeks|All subjects who were randomized and who were dispensed any study medication. For subjects with missing end of treatment observation the last non-missing observation was carried forward, including baseline.||Percentage of participants|||Number
681500|NCT01555463|Secondary|Percentage of Participants With Erythema Intensity Score at End of Treatment (LOCF)|The percentage of participants in each rating category of erythema (clear or almost clear; mild; moderate; severe) at the end of treatment is provided.|At end of treatment (LOCF), up to 12 weeks|All subjects who were randomized and who were dispensed any study medication. For subjects with missing end of treatment observation the last non-missing observation was carried forward, including baseline.||Percentage of participants|||Number
681501|NCT01555463|Secondary|Nominal Value of Inflammatory Lesion Count at End of Treatment (LOCF)|The mean (standard deviation) lesion count at the end of treatment is provided.|At end of treatment (LOCF), up to 12 weeks|All subjects who were randomized and who were dispensed any study medication. For subjects with missing end of treatment observation the last non-missing observation was carried forward, including baseline.||Inflammatory lesions||Standard Deviation|Mean
681502|NCT01555463|Secondary|Percentage of Participants With Investigator’s Global Assessment (IGA) Scores at End of Treatment (LOCF)|The IGA consists of 5 scores: 1) Clear: no papules and/or pustules; no erythema; 2) Minimal: rare papules and/or pustules; faint up to but not including mild erythema; 3) Mild: few papules and/or pustules; mild erythema; 4) Moderate: pronounced number of papules and/or pustules (but less than numerous papules and/or pustules); moderate erythema; 5) Severe: numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions; moderate to severe erythema. The percentage of participants with each score at the end of treatment is provided.|At end of treatment (LOCF), up to 12 weeks|All subjects who were randomized and who were dispensed any study medication. For subjects with missing end of treatment observation the last non-missing observation was carried forward, including baseline.||Percentage of participants|||Number
681524|NCT01555138|Secondary|Mean Daily Number of Puffs of Rescue Medication Used Over 26 Weeks of Treatment|The mean daily number of puffs of rescue medication taken by the patient will be derived. If the number of puffs is missing for part of the day (either morning or evening) then a half day will be used in the denominator. Rescue medication data recorded during the 14 day run-in period will be used to calculate the baseline. The mean change from baseline in the daily number of puffs of rescue medication will be analyzed using the same mixed model as specified for the primary analysis, with the baseline FEV1 replaced with the baseline daily rescue use.|12 and 26 weeks|||number of puffs||Standard Deviation|Mean
681503|NCT01555463|Secondary|Grouped Changes From Baseline in Erythema Intensity Score at End of Treatment (LOCF)|Erythema was rated as: clear or almost clear; mild; moderate; or severe. For the assessment of the grouped change in erythema ratings, the baseline examination was used to group into ‘improved’, ‘no change’, or ‘worsened’. A participant was considered to have an ‘improved’ erythema rating if the erythema rating was lower compared to the baseline rating, ‘no change’ if the rating was identical, and ‘worsened’ if the rating was higher. The percentage of participants in each of these categories is presented.|Baseline and end of treatment (LOCF), up to 12 weeks|All subjects who were randomized and who were dispensed any study medication. For subjects with missing end of treatment observation the last non-missing observation was carried forward, including baseline.||Percentage of participants|||Number
681504|NCT01555463|Secondary|Percentage of Participants With Investigator’s Global Assessment (IGA) Based Therapeutic Response at End of Treatment (LOCF)|Participants achieving a clear, minimal, or mild IGA at the end of treatment were considered as ‘responder’. Participants with an IGA of moderate or severe at the end of treatment were considered as ‘non-responder’. Participants who prematurely withdraw from study treatment because of lack of efficacy were coded as ‘non-responders’. The percentage of responders is presented.|At end of treatment (LOCF), up to 12 weeks|All subjects who were randomized and who were dispensed any study medication. For subjects with missing end of treatment observation the last non-missing observation was carried forward, including baseline.||Percentage of participants|||Number
681505|NCT01555463|Secondary|Percent Change From Baseline in Inflammatory Lesion Count at End of Treatment (LOCF)|The mean (standard deviation) percentage change in inflammatory lesion count from baseline to end of study is provided.|Baseline and end of treatment (LOCF), up to 12 weeks|All subjects who were randomized and who were dispensed any study medication. For subjects with missing end of treatment observation the last non-missing observation was carried forward, including baseline.||Percent change of inflammatory lesions||Standard Deviation|Mean
681506|NCT01555463|Primary|Nominal Change From Baseline in Inflammatory Lesion (IL) Count at End of Treatment (LOCF)|The mean (standard deviation) change from baseline in the inflammatory lesion count at the end of treatment is provided.|Baseline and end of treatment (LOCF), up to 12 weeks|All subjects who were randomized and who were dispensed any study medication. For subjects with missing end of treatment observation the last non-missing observation was carried forward, including baseline.||Inflammatory lesions||Standard Deviation|Mean
681507|NCT01555463|Primary|Percentage of Participants With Investigator’s Global Assessment (IGA) Based Therapeutic Success at End of Treatment (LOCF: Last Observation Carried Forward)|Static evaluation of overall severity of papulopustular rosacea at a given time: 1) Clear: no papules and/or pustules; no erythema; 2) Minimal: rare papules and/or pustules; faint up to but not including mild erythema; 3) Mild: few papules and/or pustules; mild erythema; 4) Moderate: pronounced number of papules and/or pustules (but less than numerous papules and/or pustules); moderate erythema; 5) Severe: numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions; moderate to severe erythema. Therapeutic success is defined as an IGA score of clear or minimal.|At end of treatment (LOCF), up to 12 weeks|All subjects who were randomized and who were dispensed any study medication. For subjects with missing end of treatment observation the last non-missing observation was carried forward, including baseline.||Percentage of participants|||Number
681508|NCT01555164|Secondary|Change From Baseline in 2-hour Postprandial Serum Glucose at Week 24|"The average (mean) change from baseline in 2-hour postprandial serum glucose at Week 24 was analyzed.
Mixed Meal Tolerance Test (MMTT) Full Analysis Set: randomized participants who received at least one dose of study treatment with a baseline and at least one postbaseline measurement of serum glucose at T=120 minutes during the MMTT, administered under fasting conditions, excluding participants with major eligibility protocol violations; analyzed based on the randomized treatment regardless of actual treatment received."|Baseline; Week 24|Participants in the MMTT Full Analysis Set with available data were analyzed.||mg/dL||Standard Deviation|Mean
681509|NCT01555164|Secondary|Change From Baseline in Fasting Serum Glucose at Week 24|The average (mean) change from baseline in fasting serum glucose at Week 24 was analyzed.|Baseline; Week 24|Participants in the Full Analysis Set with available data were analyzed.||mg/dL||Standard Deviation|Mean
681510|NCT01555164|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|The average (mean) change from baseline in HbA1c at Week 24 was analyzed.|Baseline; Week 24|Participants in the Full Analysis Set (randomized participants who received ≥ 1 dose of study treatment with a baseline and at least one postbaseline measurement of HbA1c, excluding participants with major eligibility violations, and analyzed based on randomized treatment, regardless of actual treatment received) with available data were analyzed.||percent of HbA1c in blood||Standard Deviation|Mean
681511|NCT01555151|Secondary|Plasma Cortisol Concentrations|Blood samples were taken from each subject participating in the study post dose at day 1 and week 4. Cortisol concentrations were evaluated. Results are presented as nmol/L|Baseline, days 1 and 28|The safety set includes all subjects who received at least one dose of study drug.||nmol/L||Standard Deviation|Mean
681512|NCT01555151|Secondary|Fractional Exhaled Nitric Oxide (FeNO)|FeNO is widely accepted as a non-invasive marker for airway inflammation such as asthma and conducted according to published guideline. FeNO was measured on days 15 and 29 after treatment.|Days 15 and 29|The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.||ppm||Standard Error|Mean
681513|NCT01555151|Secondary|Percentage of Days With no Rescue Medication Use Over 4 Weeks of Treatment|"Mixed model used: percentage of days with no rescue medication use = treatment + age + gender + baseline percentage of days with no rescue use + level of asthma control + region + center (region) + error. Center is included as a random effect nested within region.
A day with no rescue use is defined from diary data as any day where the subject does not use any puffs of rescue medication.
The total number of days with no rescue use over the 4 week treatment period is divided by the total number of evaluable days in order to derive the percentage of days with no rescue use."|4 weeks|The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.||percentage days||Standard Error|Least Squares Mean
681525|NCT01555138|Secondary|Number of COPD Exacerbations Per Patient Over 26 Weeks: Treatment Comparisons (Without Imputation; Full Analysis Set)|The number of exacerbations during the 26 week treatment period will be analyzed using a generalized linear model assuming a negative binomial distribution.|26 weeks|||participants|||Number
681514|NCT01555151|Secondary|Change From Baseline in Mean Daily Number of Puffs of Rescue Medication Over 4 Weeks of Treatment|Rescue medication data recorded during the 14 day run-in period is used to calculate the baseline. - Total number of puffs of rescue medication per day over the full 4 weeks is calculated and divided by the total number of days with non-missing rescue medication data to derive the mean daily number of puffs of rescue medication taken for the subject. - MIXED model: Change = treatment + gender + baseline mean daily number of puffs + age + level of asthma control + region + center (region) + error. Center is included as a random effect nested within region.|Baseline and 4 weeks|The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.||number of puffs||Standard Error|Least Squares Mean
681515|NCT01555151|Secondary|Change From Baseline in Asthma Control Questionnaire (ACQ-5) by Visit|Asthma symptoms were evaluated by the Asthma Control Questionnaire (ACQ). The ACQ-5 has five questions of the asthma symptoms to be answered by the patient. The overall score is the average of the 5 questions; a minimum overall score of 0 = good control of asthma whereas a maximum overall score of 6 = poor control of asthma. A negative change in score indicates improvement in symptoms. MIXED model: Change from baseline in ACQ-5 = treatment + gender + baseline ACQ-5 score + age + level of asthma control + region + center (region) + error. Center is included as a random effect nested within region. - Baseline ACQ-5 is defined as the questionnaire completed on Day 1 (randomization).|Baseline, days 8,15,22 and 29|The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.||Units on a scale||Standard Error|Least Squares Mean
681516|NCT01555151|Secondary|Change From Baseline in Mean Morning and Evening Peak Expiratory Flow Rate (PEFR) Over 4 Weeks of Treatment|Peak expiratory flow rate (PEFR) was measured via electronice Peak flow meter by patient at home. Mixed model used: change from baseline in the mean evening PEFR = treatment + age + gender + baseline evening PEFR + level of asthma control + region + center (region)+ error. Center is included as a random effect nested within region.|Baseline and week 4|The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.||Liters per min||Standard Error|Least Squares Mean
681517|NCT01555151|Secondary|Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points|Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) was measured via spirometry conducted according to internationally accepted standards. Data within 6 hr of rescue medication use is excluded from this analysis.|Days 1, 8, 15, 22, 28 and 29 at all time points|The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.||Percent||Standard Error|Least Squares Mean
681518|NCT01555151|Secondary|Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points|The Forced Expiratory Flow (FEF) 25%-75% measurement describes the amount of air expelled from the lungs during the middle half (25% - 75%) of the forced vital capacity test and is measured using spirometry.|Days 1, 8, 15, 22, 28 and 29 at all time points|The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.||Liters per second||Standard Error|Least Squares Mean
681519|NCT01555151|Secondary|Forced Vital Capacity (FVC) at All Time Points|Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Data within 6 hr of rescue medication use is excluded from this analysis. Mixed model: FVC = treatment + gender+ baseline FVC + age + level of asthma control + region + center (region) + error. Center is included as a random effect nested within region.|Days 1, 8, 15, 22, 28 and 29 at all time points|The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.||Liters||Standard Error|Least Squares Mean
681520|NCT01555151|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) After Days 8, 15 and 22 of Treatment|Forced Expiratory Volume in 1 second (FEV1) was measured via spirometry conducted according to internationally accepted standards. Measurements were taken on days 8, 15 and 22 after treatment. Data within 6 hr of rescue medication use is excluded from this analysis.|Days 8, 15 and 22|The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.||Liters||Standard Error|Least Squares Mean
681521|NCT01555151|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1)|Forced Expiratory Volume in 1 second (FEV1) was measured via spirometry conducted according to internationally accepted standards. Measurements were taken on day 29 after treatment.|Day 29|The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.||Liters||Standard Error|Least Squares Mean
681522|NCT01555138|Secondary|St Georges Respiratory Questionnaire for COPD|A Total and three component scores are calculated: Symptoms; Activity; Impacts. Each component of the questionnaire is scored separately:The score for each component is calculated separately by dividing the summed weights by the maximum possible weight for that component and expressing the result as a percentage: Score = 100 x Summed weights from all positive items in that component divided by Sum of weights for all items in that component The Total score is calculated in similar way: Score = 100 x Summed weights from all positive items in the questionnaire divided by Sum of weights for all items in the questionnaire Sum of maximum possible weights for each component and Total: Symptoms 566.2 Activity 982.9 Impacts 1652.8 Total (sum of maximum for all three components) 3201.9 The proportion of patients who achieve a clinically important improvement of at least 4 units in the total SGRQ will be analyzed. The higher the score the more symptoms of disease are present.|12 and 26 weeks|Full Analysis set||scores on a scale||Standard Error|Least Squares Mean
681523|NCT01555138|Secondary|Rescue Medication Use Over 26 Weeks: Percentage of 'Days With no Rescue Use'|A ‘day with no rescue use’ is defined from diary data as any day where the patient has taken no puffs of rescue medication. The percentage of ‘days with no rescue use’ will be derived and analyzed as for the percentage of ‘nights with no nighttime awakenings’.|26 weeks|Full Analysis Set||% of Days||Standard Error|Least Squares Mean
681526|NCT01555138|Secondary|TDI Focal Score at Week 12 and Week 26: Treatment Comparisons|The Transition Dyspnea Index (TDI) total score after 12 and 26 weeks of treatment will be analyzed using the same mixed model as specified for the primary analysis with the Baseline Dyspnea Index (BDI) total score as the baseline.Total score ranging - 9 to + 9. The lower the score, the more deterioration in severity of dyspnea. One additional option in each category, which does not contribute to the score, allows for circumstances in which impairment is due to reasons other than dyspnea.|12 and 26 weeks|||Units on a scale||Standard Error|Least Squares Mean
681527|NCT01555138|Secondary|Analysis of AUC (5 Min – 4 h) for FEV1 (L) at Week 12 and Week 26: Treatment Comparison|The standardized (with respect to the length of time) AUC for FEV1 will be calculated between 5 min and 4 h post morning dose as the sum of trapezoids divided by the length of time at Day 84 (Visit 6) and Day 182 (Visit 10). Scheduled (not actual) time points are to be used. FEV1 measurements taken within 6 h of rescue use will be set to missing before the standardized AUC is calculated.|12 and 26 weeks|Full analysis set||Liters||Standard Error|Least Squares Mean
681528|NCT01555138|Secondary|FVC Over 26 Weeks of Treatment|FVC at each time point, for each visit, will be analyzed using the same mixed model as specified for the primary analysis. Least squares means will be displayed by treatment group.|12 and 26 weeks|Full analysis set||Liters||Standard Error|Least Squares Mean
681529|NCT01555138|Secondary|FEV1 (L) at Individual Time Points After 26 Weeks Treatment: Treatment Comparisons|FEV1 at each time point, for each visit, will be analyzed using the same mixed model as specified for the primary analysis. Least squares means will be displayed by treatment group .|26 weeks|Full analysis set||Liters||Standard Error|Least Squares Mean
681530|NCT01555138|Secondary|FEV1 (L) at Individual Time Points After 12 Weeks Treatment: Treatment Comparisons|FEV1 at each time point, for each visit, will be analyzed using the same mixed model as specified for the primary analysis. Least squares means will be displayed by treatment group.|12 weeks|Full analysis set||Liters||Standard Error|Least Squares Mean
681531|NCT01555138|Secondary|Trough FEV1 (L) at Week 26 (Imputed With LOCF): Treatment Comparisons|Trough FEV1 is defined as the average of the 23 h 10 min and the 23 h 45 min values taken in the clinic at Visit 11.|26 weeks|Full analysis set||Liters||Standard Error|Least Squares Mean
681532|NCT01555138|Primary|Trough Forced Expiratory Volume in One Second (FEV1) at 12 Weeks (Imputed With LOCF): Treatment Comparisons|Spirometry conducted to internationally accepted standards. Trough FEV1 defined as the mean of the FEV1 measurements at 23 h 10 min and 23 h 45 min post the Day 84 morning dose. The primary variable (imputed with last observation carried forward) will be analysed using a mixed model for the Per Protocol Set (PPS). The model will contain treatment as a fixed effect with the baseline FEV1 measurement, FEV1 prior to inhalation and FEV1 10-15 min post inhalation of salbutamol (components of reversibility at Visit 1) as covariates.|12 weeks|full analysis set||Liters||Standard Error|Least Squares Mean
681533|NCT01555073|Secondary|Quality of Life|To register the quality of life of patients receiving the four study arms following uterine artery embolisation during immediate and long term time periods.|Expected average of 12 weeks|Early termination due to lost of follow-up for primary outcome at 3 months|||||
681534|NCT01555073|Primary|Post Operative Pain Control|To evaluate the post operative pain control of the four groups in immediate postoperative period and months following uterine artery embolisation procedure.|Expected average of 12 weeks|Early termination due to lost of follow-up for primary outcome at 3 months|||||
681535|NCT01554982|Other Pre-specified|IV Iron Use|Percent of subjects with No IV iron intake from first dose of study drug to Week 48|48 weeks|||percentage of participants|||Number
681536|NCT01554982|Other Pre-specified|Hemoglobin- Week 48||48 weeks|||g/dL||Standard Deviation|Mean
681537|NCT01554982|Other Pre-specified|Hemoglobin- Baseline||Baseline|||g/dL||Standard Deviation|Mean
681538|NCT01554982|Other Pre-specified|TSAT- Week 48||48 weeks|||percentage of saturation||Standard Deviation|Mean
681539|NCT01554982|Other Pre-specified|Transferrin Saturation (TSAT) - Baseline||Baseline|||percentage of saturation||Standard Deviation|Mean
681540|NCT01554982|Other Pre-specified|Ferritin- Week 48||48 weeks|||ng/mL||Standard Deviation|Mean
681541|NCT01554982|Other Pre-specified|Ferritin- Baseline||Baseline|||ng/mL||Standard Deviation|Mean
681542|NCT01554982|Other Pre-specified|Serum Phosphorus- Week 48||48 weeks|||mg/dL||Standard Deviation|Mean
681543|NCT01554982|Other Pre-specified|Serum Phosphorus- Baseline||Baseline|||mg/dL||Standard Deviation|Mean
681544|NCT01554982|Primary|Safety Parameters|Safety was assessed by recording and monitoring adverse events (AEs), serious adverse events (SAEs), and sequential laboratory data. Rates of AEs were summarized by system organ class, preferred term, severity, and suspected relationship to KRX-0502 (ferric citrate).|48 Weeks|Safety Population; Treatment Emergent Adverse Events (TEAEs), not including SAEs, reported include only those occurring at a frequency >5%||participants|||Number
681545|NCT01554904|Secondary|Apnea-Hypopnea Index (AHI)|The number of apneas and hypopneas per hour of monitoring|baseline and after 6 weeks of facial muscle training|Participants completing 6 weeks of training and second sleep study||events per hour||Standard Deviation|Mean
681546|NCT01554904|Primary|Snore Index|The snore index is the number of snores per hour of monitoring. The pre-treatment and post-treatment (6 weeks) values will be compared. A snore is a vibratory noise usually noted during inspiration and associated with vibration of the uvula and palate. The snore sensor in this study is the nasal pressure cannula connected to a sensitive pressure transducer. Snoring is detected as a fine (high frequency) oscillation superimposed on the nasal pressure waveform. The device [Sleep Scout (ClevMed, Cleveland Ohio)] has an automated scoring detection algorithm to identify breaths with snoring. Each breath with vibration is counted as a snore. As the algorithm is automated and the same snore threshold was used for both baseline and 6 week sleep studies, this prevents technologist bias in detecting snores (breaths with vibration).|baseline and after 6 weeks of facial muscle training|Subjects completing 6 weeks of training and Home Sleep Test # 2||snores per hour of monitoring||Standard Deviation|Mean
681547|NCT01554891|Primary|Sensitivity and Specificity of the SAFE-TBI|Sensitivity = True Positives/(True Positive + False Negatives) Specificity = True Negatives/(True Negative + False Positives) Cutoff 2 = At least moderate evidence of TBI vs. no or weak evidence of TBI|6-months after medical evacuation|Data were only collected for cohort 3.||percentage|||Number
681548|NCT01554891|Primary|Concordance Rate of Current VA Screening Instruments and the SAFE-TBI.|Concordance rate of current VA TBI screening instruments and the SAFE-TBI in 100 OEF/OIF/OND veterans who have screened positive for TBI (Cohort 2) Cohort 2: The primary endpoint for this sub-study is the distribution of SAFE-TBI outcome (percent assigned to each evidence category of the SAFE-TBI) in a group of veterans who have screened positive on the VA TBI screen. (Speciﬁc Aim 2).|baseline|Analyses done for Cohort 2 only.||percentage of participants||95% Confidence Interval|Number
683612|NCT01525550|Secondary|Oral Clearance (CL/F) of Sunitinib and Its Metabolite SU012662|Clearance is a quantitative measure of the rate at which a drug substance is removed from the body.|Pre dose on Day 15 of Cycle 1, Day 1 of Cycle 2, 3 and 5 (each cycle 28 days)||||||
681549|NCT01554891|Primary|Test-retest Reliability SAFE-TBI|Reliability of SAFE-TBI, as determined by test-retest and inter-rater reliability, in a sample of 100 veterans recently returned from deployment (Cohort 1) Cohort 1: The primary endpoints for this sub-study (cohort) are the degree of agreement for SAFE-TBI outcome (no evidence of TBI vs. at least, weak evidence of TBI) across the two assessment time points (initial vs. 4 to 6 weeks) as well as the two rater types TRC vs. TBIC. (Speciﬁc Aim 1).|Up to 6 weeks|Analyses done on Cohort 1, and a subset of Cohort 2 and 3 who got repeat interview.||kappa (reliability)||95% Confidence Interval|Number
681550|NCT01554579|Secondary|SF-36|The SF-36 (acute version 2) was a 36 question survey administered at Baseline and at the end of study or early termination (Week 4). The questionnaire contained numerous domain scores to evaluate physical function, mental function, general health, bodily pain, social functioning and vitality. The question of interest for the analysis was question #1 regarding walking pain. Scores range from 0 - 100. A lower score means decreased pain while walking and a higher score means increased pain while walking.|4 Weeks|Per protocol population defined as subjects who received at least 1 dose of drug, had at least 1 post-baseline efficacy measure, complied with protocol and did not have major protocol deviations. Compliance with the protocol defined as having (in the last week of the study) a weekly average NPRS score w/ at least 50% non-missing dairy NPRS scores.||units on a scale||Standard Deviation|Mean
681551|NCT01554579|Secondary|WOMAC Scores|This is the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). This is a questionnaire that asks subjects to evaluate their pain, stiffness, and physical activities affecting their knee over the past 48 hours. Subjects evaluate their pain, stiffness and physical activities by selecting a number between 0 and 10 where 0 is no pain/no stiffness/no difficulty doing physical activities and 10 is extreme pain/extreme stiffness/extreme difficulty doing physical activities. The questionnaire was administered at Screening, Baseline and at the end of Week 4 by telephone (an interactive voice response system [IVRS]) before bedtime. The scores for each category are totaled (range is 0-100). A lower total score means less pain and a higher total score means greater pain.|4 Weeks|Per protocol population defined as subjects who received at least 1 dose of drug, had at least 1 post-baseline efficacy measure, complied with protocol and did not have major protocol deviations. Compliance with the protocol defined as having (in the last week of the study) a weekly average NPRS score w/ at least 50% non-missing dairy NPRS scores.||units on a scale||Standard Deviation|Mean
681552|NCT01554579|Primary|The Primary Efficacy Endpoint of This Study is the Weekly Average Daily NPRS (Average Pain)|Subjects were instructed to select a number on a scale that best described their knee arthritis pain during the past 24 hours. The scale was between 0 and 10 where 0 was no pain and 10 was the worst possible pain. The scale was completed by telephone (an interactive voice response system [IVRS]) every evening before bedtime.|2 Weeks|Per protocol population defined as subjects who received at least 1 dose of drug, had at least 1 post-baseline efficacy measure, complied with protocol and did not have major protocol deviations. Compliance with the protocol defined as having (in the last week of the study) a weekly average NPRS score w/ at least 50% non-missing dairy NPRS scores.||units on a scale||Full Range|Mean
681553|NCT01554241|Secondary|Free 25-OH Vitamin D3|circulating free 25-OH vitamin D3 concentration|16 weeks|||pg/mL||Standard Deviation|Mean
681554|NCT01554241|Primary|Total 25-OH Vitamin D3 Level|circulating total 25-OH vitamin D concentration|16 weeks|||ng/mL||Standard Deviation|Mean
681555|NCT01554176|Primary|Number of Participants Who Discontinued Study Drug Due to an AE During Run-out Phase|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) or a preexisting condition which is temporally associated with study drug administration, is also an AE. Participants who discontinued study drug treatment due to an AE during the 2-week run-out phase are counted once in this summary.|From first run-out dose (following Week 6 visit) up to Week 8 (2 weeks)|All Participants as Treated (APaT): Population includes participants who took ≥1 dose of study drug.||Participants|||Number
681556|NCT01554176|Primary|Number of Participants With an AE During Run-out Phase|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with study drug administration, is also an AE. Participants with one or more AEs during the 2-week run-out phase and/or during the 2-week follow up after the last dose of study drug, are counted once in this summary.|From first run-out dose (following Week 6 visit) up to 14 days after last dose of study drug (approximately 4 weeks)|All Participants as Treated (APaT): Population includes participants who took ≥1 dose of study drug.||Participants|||Number
681557|NCT01554176|Primary|Number of Participants Who Discontinued Study Drug Due to an AE During Treatment Phase|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with study drug administration, is also an AE. Participants who discontinued study drug treatment due to an AE during the treatment phase (up to study Week 6) are counted once in this summary.|Up to Week 6|All Participants as Treated (APaT): Population includes participants who took ≥1 dose of study drug.||Participants|||Number
681558|NCT01554176|Primary|Number of Participants With an Adverse Event (AE) During Treatment Phase|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with study drug administration, is also an AE. Participants with one or more AEs during the treatment phase (up to study Week 6) are counted once in this summary.|Up to Week 6|All Participants as Treated (APaT): Population includes participants who took ≥1 dose of study drug.||Participants|||Number
681631|NCT01553292|Secondary|Oxygen Saturation Before the Procedure|Oxygen saturation is measured by pulse oximetry and express as proportion out of one which equal to percentage of 100. The number can be any where between 0.21 to 1 which is equal to percentage of 21 to 100.|1 hour|The mean of saturation of all participants before ECALMIST||Proportion of oxygen saturation||Standard Deviation|Mean
681559|NCT01554176|Secondary|Percentage of Participants With HAM-D17 Remission (HAM-D17 Total Score ≤7) at Week 6|The HAM-D, an instrument for evaluating severity of symptoms of depression, was completed by the participant. The instrument used in this study was the 17-item version (HAM-D17). Each item is rated on either a 3-point scale (0 to 2) or a 5-point scale (0 to 4), with higher scores indicating greater symptom severity. Total score ranged from 0 to 54. The following symptoms were rated on a 5-point scale (0-4): depressed mood, low self-esteem (guilt), suicidal thoughts, work and interests, psychomotor retardation, psychomotor agitation, anxiety (psychic), anxiety (somatic), and hypochondriasis (somatization). The following symptoms were rated on a 3-point scale (0-2): insomnia (initial), insomnia (middle), insomnia (late), gastrointestinal symptoms (appetite), somatic symptoms (general), sexual disturbances, insight, and weight loss. A participant with HAM-D17 total score ≤7 at Week 6 of the Treatment Phase was defined to have achieved HAM-D17 remission.|Week 6|Full Analysis Set (FAS) - population included participants who took ≥1 dose of study drug and had a baseline and Week 6 HAM-D17 score.||percentage of participants|||Number
681560|NCT01554176|Secondary|Change From Baseline to Week 6 in the Hamilton Depression Rating Scale, 17-item Version (HAM-D17) Bech Subscale Score|The HAM-D, an instrument for evaluating severity of symptoms of depression, was completed by the participant. The instrument used in this study was the 17-item version (HAM-D17). The Bech subscale of the HAM-D17 is composed of 6 identified items out of the 17 items rated. Each item is rated on either a 3-point scale (0 to 2) or a 5-point scale (0 to 4). Total score ranged from 0 to 22, with a higher score indicating greater symptom severity. The following symptoms were rated on a 5-point scale (0-4): depressed mood, low self-esteem (guilt), work and interests, psychomotor retardation, and anxiety (psychic). The following symptom was rated on a 3-point scale (0-2): somatic symptoms (general). The reported measure is the change from baseline to Week 6 of the Treatment Phase; improvement in symptoms is represented by negative values.|Baseline and Week 6|Full Analysis Set (FAS) - population included participants who took ≥1 dose of study drug and had a baseline and Week 6 HAM-D17 Beck Subscale score.||score on a scale||Standard Deviation|Mean
681561|NCT01554176|Secondary|Change From Baseline to Week 6 in MADRS Total Score Excluding the Sleep Item|"The MADRS is a 10-item clinician-rated instrument for evaluating severity of symptoms of depression. Each item is rated on a scale from 0 to 6, with higher scores indicating greater symptom severity. The total score ranged from 0 to 54, with higher scores corresponding to greater symptom severity. This measure considered 9 of the 10 MADRS items: apparent sadness, reported sadness, inner tension, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. It excluded reduced sleep. The reported measure is the mean change from baseline to Week 6 of the Treatment Phase; improvement in symptoms is represented by negative values."|Baseline and Week 6|Full Analysis Set (FAS) - population included participants who took ≥1 dose of study drug and had a baseline and Week 6 MADRS score.||score on a scale||Standard Deviation|Mean
681562|NCT01554176|Primary|Change From Baseline to Week 6 in Montgomery Asberg Depression Rating Scale (MADRS) Total Score|The MADRS is a 10-item clinician-rated instrument for evaluating severity of symptoms of depression. Each item is rated on a scale from 0 to 6, with total scores ranging from 0 to 60; higher scores correspond to greater symptom severity. The reported measure is the mean change from baseline to Week 6 of the Treatment Phase; improvement in symptoms is represented by negative values.|Baseline and Week 6|Full Analysis Set (FAS) - population included participants who took ≥1 dose of study drug and had a baseline and Week 6 value.||score on a scale||Standard Deviation|Mean
681563|NCT01554163|Secondary|Time-Weighted Mean Response on the Investigator Global Assessment of Response to Therapy|Study investigators were asked to rate the global assessment of participant response to therapy on a Likert scale from 0 to 4, with 0 = excellent, 1 = good, 2 = fair, 3 = poor, 4 = none. The calculation of the time-weighted average was done by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.|Week 6, Week 12|The population consisted of all participants that received one dose of study medication and had a value at Week 6 and Week 12 for the Investigator Global Assessment of Response to Therapy.||Score on a Scale||Standard Error|Least Squares Mean
681564|NCT01554163|Secondary|Time-Weighted Mean Change From Baseline in the WOMAC Stiffness Subscale|The WOMAC osteoarthritis scale consists of 24 items in 3 subscales: pain, stiffness, and physical function. The stiffness subscale rates stiffness after first waking and later in the day using a visual analog scale (VAS) from 0-100mm where 0 is the best possible level of stiffness and 100 is the highest level of stiffness. The stiffness subscale is calculated as the average of the responses to the 2 questions related to stiffness. The calculation of the time-weighted average was done by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.|Baseline, Week 2, Week 6, Week 12|The population consisted of all paricipants that received one dose of study medication and had a baseline value for the WOMAC stiffness subscale, and had at least one post-randomization observation.||Score on a Scale||Standard Error|Least Squares Mean
681565|NCT01554163|Secondary|Time-Weighted Mean Change From Baseline in the Investigator Global Assessment of Disease Status|Study investigators were asked to rate the global assessment of participant disease status on a Likert scale from 0 to 4, with 0 = very well, 1 = good, 2 = fair, 3 = poor and 4 = very poor. The calculation of the time-weighted average was done by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.|Baseline, Week 2, Week 6, Week 12|The population consisted of all participants that received one dose of study medication and had a baseline value for the Investigator Global Assessment of Disease Status, and had at least one post-randomization observation.||Score on a Scale||Standard Error|Least Squares Mean
681566|NCT01554163|Secondary|Time-Weighted Mean Response in the Participant Global Assessment of Response to Therapy|Participants were asked to rate their global assessment of response to therapy on a Likert scale from 0 to 4, with 0 = excellent, 1 = good, 2 = fair, 3 = poor, 4 = none. The calculation of the time-weighted average was done by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.|Week 2, Week 6, Week 12|The population consisted of all participants that received one dose of study medication and had a Week 2, Week 6, and Week 12 value for the Participant Global Assessment of Response to Therapy.||Score on a Scale||Standard Error|Least Squares Mean
681567|NCT01554163|Secondary|Time-Weighted Mean Change From Baseline in the Participant Global Assessment of Disease Status|The Participant Global Assessmet of Disease was a one item questionnaire that asked participants to answer the following question, “Considering all the ways your arthritis affects you, mark (X) on the scale for how well you are doing.” The questionnaire employed a 0-100 mm visual analog scale (VAS) to record participant responses, with 0 representing the best possible assessment and 100 representing the worst possible assessment. The calculation of the time-weighted average was done by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.|Baseline, Week 2, Week 6, Week 12|The population consisted of all participants that received one dose of study medication and had a baseline value for the Participant Global Assessment of Disease Status, and had at least one post-randomization observation.||Score on a Scale||Standard Error|Least Squares Mean
681568|NCT01554163|Secondary|Time-Weighted Mean Change From Baseline in the WOMAC Physical Function Subscale|The WOMAC osteoarthritis scale consists of 24 items in 3 subscales: pain, stiffness, and physical function. The physical function subscale rates participant pain during stair use, rising from sitting, standing, bending, walking, getting in/out of a car, shopping, putting on/taking off socks, rising from bed, lying in bed, getting in/out of the bath, sitting, getting on/off the toilet, heavy household duties, and light household duties using a visual analog scale (VAS) from 0-100mm where 0 is the best possible level of functioning and 100 is the highest level of functioning. The physical function subscale was calculated as the average of the responses to the 17 questions related to functional status. The calculation of the time-weighted average was done by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.|Baseline, Week 2, Week 6, Week 12|The population consisted of all participants that received one dose of study medication and had a baseline value for the WOMAC physical function subscale, and had at least one post-randomization observation.||Score on a Scale||Standard Error|Least Squares Mean
681569|NCT01554163|Primary|Time-Weighted Mean Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale|The WOMAC osteoarthritis scale consists of 24 items in 3 subscales: pain, stiffness, and physical function. The pain subscale rates participant pain during walking, using stairs, in bed, sitting or lying, and standing using a visual analog scale (VAS) from 0-100mm where 0 is the best possible level of pain and 100 is the highest level of pain. The pain subscale is calculated as the average of the responses to the 5 questions related to pain. The calculation of the time-weighted average was done by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.|Baseline, Week 2, Week 6, Week 12|The population consisted of all participants that received one dose of study medication and had a baseline value for the WOMAC pain subscale, and had at least one post-randomization observation.||Score on a Scale||Standard Error|Least Squares Mean
681570|NCT01553851|Secondary|Percent of Participants With Metabolic Changes in OCSCC Using FDG-PET/CT Imaging.|Intratumarol metabolic changes were evaluated by changes in in SUVmax in the primary tumor; quantitative analysis SUVmax with the primary tumor site was determined within a volume of interest around the tumor using a Siemens eSoft workstation.|Baseline and Day 14|Seven patients did not meet protocol-defined tumor size criteria (n=3), withdrew from study (n=3) or declined post GSK1120212 FDG-PET/CT(n=1)||percentage of participants|||Number
681571|NCT01553851|Secondary|Percent Change in Tumor Size Area||Baseline and Day 15|Quantitative changes in tumor size based on clinical examination of area of tumor at baseline and after GSK1120212 based on two dimensional measurements.||percent change in tumor size area||Full Range|Median
681572|NCT01553851|Secondary|Safety of GSK1120212|Number of adverse events were monitored for 30 day following last dose of GSK1120212|1st 4-6 week follow-up visit|||Adverse events|||Number
681573|NCT01553851|Secondary|Percent Change in Maximum Standard Uptake Value in Oral Cavity Saqumous Cell Carcinoma (OCSCC) Using F18-Fluorodeoxyglucose-Positron Emission Tomography/Computed Tomography (FDG-PET/CT).||Baseline and Day 14|Seven patients did not meet protocol-defined tumor size criteria (n=3), withdrew from study (n=3) or declined post GSK1120212 FDG-PET/CT(n=1)||percentage change in SUVmax||Full Range|Median
681574|NCT01553851|Secondary|Flow Cytometric Analysis of the Peripheral Blood and Tumor.|"Peripheral blood - baseline and Day 14
Tumor - baseline and Day 15"|Baseline, Day 14, and Day 15|There was an insufficient amount of tissue to collected. The data was not collected and the outcome measure was not analyzed.|||||
681575|NCT01553851|Secondary|Percentage of Participants With Clinical Response Induced by GSK1120212, as Determined by Change in Tumor Size.|Clinical Response was evaluted by quantitative changes in tumor size based on clinical examination of area of tumor at baseline and after GSK1120212 based on two dimensional measurements.|Baseline and Day 15|||percentage of participants|||Number
681576|NCT01553851|Secondary|Tumor Specific Findings for Pathologic Changes Including Proliferation (Ki-67 Staining), Tumor Vasculature Staining (Microvessel Density), ERK1/2 Mediated Changes in p27 (Kip1) & Flow Cytometric Analysis of the Peripheral Blood & Tumor.||Baseline and Day 15|There was an insufficient amount of tissue to collected. The data was not collected and the outcome measure was not analyzed.|||||
681577|NCT01553851|Primary|Number of Participants With Changes in TumorCell Surface CD44 Expression After Treatment With GSK1120212.|Pre-post measure of CD44 expression using IHC.|Baseline and Day 15|||Participants|||Number
681578|NCT01553851|Primary|Number of Participants With Changes in Putative Tumor Initiating Cell Populations as Defined by Cell Surface CD44 and Intracellular Phospho-ERK1/2 Staining After Treatment With GSK1120212.|Pre-post measure of p-EKP expression was measured by change in staining intensity and quartile distribution.|Baseline and Day 15|Only15 of the 17 participants had sufficient pre- and post-treatment biopsies with sufficient tumor content to be evaluated for this biomarker assessment.||participants|||Number
681632|NCT01553292|Secondary|CPAP Pressure Before the Proceudre|Continuous positive airway pressure (CPAP) pressure is measured in centimeter of water as recorded from CPAP machine (continuous positive airway pressure)|1 hour|The mean of CPAP pressure that is measured by centimeter of water of all the participant before ECALMIST||Centimeter of water||Standard Deviation|Mean
684441|NCT01516879|Primary|Percent Change From Baseline in LDL-C at Week 52|Cholesterol was measured by means of ultracentrifugation.|Baseline and Week 52|Full Analysis Set (all randomized subjects who received at least 1 dose of study drug).||percent change||Standard Error|Least Squares Mean
681579|NCT01552772|Secondary|CGI-I Scale Score in LOCF Data.|The efficacy of trial medication were rated for each participant using the Clinical Global Impression Improvement (CGI-I) scale. The study physician must rate the participant's total improvement whether or not it is due entirely to drug treatment. All responses were compared to the participant's condition a baseline. Response choices include: 0 = not assessed; 1 =very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 =minimally worse; 6 = much worse; and 7 = very much worse.|Week 1, 2 and 4|The efficacy analyses dataset consisted of enrolled participants who have at least one efficacy measurement. The LOCF method was used to impute missing data at visits after Baseline for the efficacy analysis and for the safety EPS assessment scales.||Units on a scale||Standard Deviation|Mean
681580|NCT01552772|Secondary|Clinical Global Impression Improvement (CGI-I) Scale Score in OC Data.|The efficacy of trial medication were rated for each participant using the CGI-I scale. The study physician must rate the participant's total improvement whether or not it is due entirely to drug treatment. All responses were compared to the participant's condition a baseline. Response choices include: 0 = not assessed; 1 =very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 =minimally worse; 6 = much worse; and 7 = very much worse.|Week 1, 2, 4 and Last visit (Day 28).|The efficacy analyses dataset consisted of enrolled participants who had at least one efficacy measurement. The OC dataset are participants who were evaluated at that visit on the efficacy variable under analysis (i.e. participants who had missing data due to drop out or other reasons were not included in the OC dataset).||Units on a scale||Standard Deviation|Mean
681581|NCT01552772|Secondary|Change From Baseline in CGI-S Score in LOCF Data.|The severity of illness for each participant was rated using the CGI-S scale. To assess CGI-S, the rater or investigator answered the following question: “Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?” Response choices included: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.|Baseline, Week 1, 2 and 4.|The efficacy analyses dataset consisted of enrolled participants who have at least one efficacy measurement. The LOCF method was used to impute missing data at visits after Baseline for the efficacy analysis and for the safety EPS assessment scales.||Units on a scale||Standard Deviation|Mean
681582|NCT01552772|Secondary|Change From Baseline in Clinical Global Impression Severity (CGI-S) Score in OC Data.|The severity of illness for each participant was rated using the CGI-S scale. To assess CGI-S, the study physician answered the following question: “Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?” Response choices included: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.|Baseline, Week 1, 2, 4 and Last visit (Day 28).|The efficacy analyses dataset consisted of enrolled participants who had at least one efficacy measurement. The OC dataset are participants who were evaluated at that visit on the efficacy variable under analysis (i.e. participants who had missing data due to drop out or other reasons were not included in the OC dataset).||Units on a scale||Standard Deviation|Mean
681583|NCT01552772|Secondary|Change From Baseline in PANSS Negative Sub-scale Score for LOCF Data.|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline, Week 1, 2 and 4|The efficacy analyses dataset consisted of enrolled participants who have at least one efficacy measurement. The LOCF method was used to impute missing data at visits after Baseline for the efficacy analysis and for the safety EPS assessment scales.||Units on a scale||Standard Deviation|Mean
681584|NCT01552772|Secondary|Change From Baseline in PANSS Negative Sub-scale Score for OC Data.|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline, Week 1, 2, 4 and Last visit (Day 28).|The efficacy analyses dataset consisted of enrolled participants who had at least one efficacy measurement. The OC dataset are participants who were evaluated at that visit on the efficacy variable under analysis (i.e. participants who had missing data due to drop out or other reasons were not included in the OC dataset).||Units on a scale||Standard Deviation|Mean
681585|NCT01552772|Secondary|Change From Baseline in PANSS Positive Sub-scale Score for LOCF Data.|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS positive subscale score was the sum of the rating scores for the 7 positive scale items from the PANSS panel. The 7 positive symptom constructs are delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline, Week 1, 2 and 4|The efficacy analyses dataset consisted of enrolled participants who have at least one efficacy measurement. The LOCF method was used to impute missing data at visits after Baseline for the efficacy analysis and for the safety EPS assessment scales.||Units on a scale||Standard Deviation|Mean
681597|NCT01552681|Secondary|Percent of Participants With Adverse Events of Grade 3 or Higher|Grades are based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 4.0 over the duration of the study. Participants who experienced at least one grade 3 or higher adverse event (AE) are counted only once. The adverse events are treatment-emergent, which means that the AE occurred after taking the first dose of study drug.|From the time of administration of the first dose of study drug until the participant completed study participation, an average of 48 weeks.|The Safety population included all randomized subjects who received at least one dose of either baminercept or placebo.||Percent of participants|||Number
681586|NCT01552772|Secondary|Change From Baseline in PANSS Positive Sub-scale Score for OC Data.|The Positive and Negative Syndrome Scale (PANSS) consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS positive subscale score was the sum of the rating scores for the 7 positive scale items from the PANSS panel. The 7 positive symptom constructs are delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline, Week 1, 2, 4 and Last visit (Day 28).|The efficacy analyses dataset consisted of enrolled participants who had at least one efficacy measurement. The OC dataset are participants who were evaluated at that visit on the efficacy variable under analysis (i.e. participants who had missing data due to drop out or other reasons were not included in the OC dataset).||Units on a scale||Standard Deviation|Mean
681587|NCT01552772|Secondary|Change From Baseline in Total Score of PANSS for Last Observation Carried Forward (LOCF) Data.|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline, Week 1, 2 and 4|The efficacy analyses dataset consisted of enrolled participants who have at least one efficacy measurement. The LOCF method was used to impute missing data at visits after Baseline for the efficacy analysis and for the safety extrapyramidal symptoms (EPS) assessment scales.||Units on a scale||Standard Deviation|Mean
681588|NCT01552772|Secondary|Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) for Observed Cases (OC) Data.|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline, Week 1, 2, 4 and Last visit (Day 28).|The efficacy analyses dataset consisted of enrolled participants who had at least one efficacy measurement. The OC dataset are participants who were evaluated at that visit on the efficacy variable under analysis (i.e. participants who had missing data due to drop out or other reasons were not included in the OC dataset).||Units on a scale||Standard Deviation|Mean
681589|NCT01552772|Primary|Number of Participants With Adverse Events (AE).|An AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a participant while enrolled in the trial, whether or not it was considered drug related by the study physician. A serious adverse event (SAE) was any untoward medical occurrence that resulted in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. TEAE stands for treatment emergent adverse events.|From the time the informed consent (ICF) was signed until follow-up at 30 days after the last trial visit (Day 28).|The safety analyses dataset consisted of data from all enrolled participants who received one dose of trial medication, regardless of any protocol deviation. All observed data for these participants were included.||Participants|||Number
681590|NCT01552694|Primary|Inflammatory Biomarker 3: Serum D-dimer Concentration|There are 3 levels of the primary outcome measure, hsCRP, IL-6, and D-dimer|2 months|||µg FEU/mL||Standard Deviation|Mean
681591|NCT01552694|Primary|Inflammatory Biomarker 2: Plasma IL-6 Concentration|There are 3 levels of the primary outcome measure; hsCRP, IL-6, and D-dimer concentrations measured at baseline and week 8|2 months|||pg/mL||Standard Deviation|Mean
681592|NCT01552694|Secondary|Blood Endothelial Progenitor Cells|Monocytes are isolated from 20 mL blood. CD34+/VEGFR2+ and CD133+/CD34+/VEGFR2+ monocytes are counted (flow cytometry) and represent markers for endothelial progenitor cell number.|2 months||||||
681593|NCT01552694|Secondary|Adipose Inflammation|Adipose tissue from obese, insulin resistant subjects is characterized by increased macrophage infiltration and overexpression of inflammatory cytokines/chemokines. In obese humans, the presence of CD68+ macrophages in direct contact with mature adipocytes has been noted in histologic sections of adipose tissue, and these appear as a macrophage “crown” around individual adipocytes. In adipocyte sections, we will use positive immunohistochemical staining for CD68 to quantify the density of macrophages and the frequency of “crown’ like structures.|2 months||||||
681594|NCT01552694|Primary|Inflammatory Biomarker 1: Plasma hsCRP Concentration|Fasting serum and plasma samples obtained at baseline and week 8 are batched for ELISA analysis (end of sudy) of hsCRP, IL-6 and D-dimer concentrations.|2 months|||mg/L||Standard Deviation|Mean
681595|NCT01552681|Secondary|Percent of Participants With Injection Site Reaction or Any Grade 2 or Higher Adverse Event Within 24 Hours of Injection|Grades are based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 4.0 over the duration of the study. Participants who experienced at least one injection site reaction or Grade 2 or higher adverse event within 24 hours of injection are counted only once. The adverse events are treatment-emergent, which means that the AE occurred after taking the first dose of study drug.|From the time of administration of the first dose of study drug until the participant completed study participation, an average of 48 weeks.|The Safety population included all randomized subjects who received at least one dose of either baminercept or placebo.||Percent of participants|||Number
681596|NCT01552681|Secondary|Percent of Participants With Grade 3 or Higher Infection Adverse Event|Grades are based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 4.0 over the duration of the study. Participants who experienced at least one grade 3 or higher infection adverse event (AE) are counted only once. The adverse events are treatment-emergent, which means that the AE occurred after taking the first dose of study drug.|From the time of administration of the first dose of study drug until the participant completed study participation, an average of 48 weeks.|The Safety population included all randomized subjects who received at least one dose of either baminercept or placebo.||Percent of participants|||Number
681623|NCT01553539|Primary|Number of Participants Who Experienced Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0|See the adverse event tables for specifics.|Approximately 1 year|||Participants experiencing adverse events|||Number
681598|NCT01552681|Secondary|Change From Baseline in the Short Form 36 (SF-36) Physical and Mental Health Component Summary Scores (PCS and MCS) at Week 48|The SF-36 questionnaire completed by the subject measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Summary measures were standardized to have a mean of 50 and a standard deviation of 10 in the 1998 general US population. Change from baseline is computed as the value at Week 48 minus the baseline value. A positive value in change from Baseline indicates an improvement and a negative value indicates worsening.|Week 48|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had SF-36 data at Baseline and Week 48. Data were not available for five participants who received baminercept and one participant who received placebo.||units on a scale||Standard Deviation|Mean
681599|NCT01552681|Secondary|Change From Baseline in the Short Form 36 (SF-36) Physical and Mental Health Component Summary Scores (PCS and MCS) at Week 24|The SF-36 questionnaire completed by the subject measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Summary measures were standardized to have a mean of 50 and a standard deviation of 10 in the 1998 general US population. Change from baseline is computed as the value at Week 24 minus the baseline value. A positive value in change from Baseline indicates an improvement and a negative value indicates worsening.|Week 24|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had SF-36 data at Baseline and Week 24. Data were not available for four participants who received baminercept and two participants who received placebo.||units on a scale||Standard Deviation|Mean
681600|NCT01552681|Secondary|Change From Baseline in Tear Secretion as Measured by Lissamine Green Staining at Week 48|Lissamine green stain was dropped into the participant's eyes and then an ophthalmologist used a slit lamp to examine the eye surface. Six areas of the eye surface were evaluated and scored from 0 to 3, with 0 being no tear film damage to 3, extensive tear film damage. The scores of all six areas in both eyes were totaled to obtain an overall score between 0 and 18. A higher score indicates insufficient tear flow and excessive dryness. Change from baseline was computed as the value at Week 48 minus the baseline value. A negative value in change from Baseline indicates an improvement and a positive value indicates worsening.|Week 48|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had Lissamine Green Staining data at Baseline and Week 48. Data were not available for eight participants who received baminercept and one participant who received placebo.||units on a scale||Standard Deviation|Mean
681601|NCT01552681|Secondary|Change From Baseline in Tear Secretion as Measured by Lissamine Green Staining at Week 24|Lissamine green stain was dropped into the participant's eyes and then an ophthalmologist used a slit lamp to examine the eye surface. Six areas of the eye surface were evaluated and scored from 0 to 3, with 0 being no tear film damage to 3, extensive tear film damage. The scores of all six areas in both eyes were totaled to obtain an overall score between 0 and 18. A higher score indicates insufficient tear flow and excessive dryness. Change from baseline was computed as the value at Week 24 minus the baseline value. A negative value in change from Baseline indicates an improvement and a positive value indicates worsening.|Week 24|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had Lissamine Green Staining data at Baseline and Week 24. Data were not available for six participants who received baminercept and three participants who received placebo.||units on a scale||Standard Deviation|Mean
681602|NCT01552681|Secondary|Change From Baseline in Tear Secretion as Measured by Schirmer's I Test at Week 48|A paper strip was placed within each lower eyelid and the participant's eyes were closed for 5 minutes. The wet paper was removed after 5 minutes and the length of wetting was recorded to the nearest 0.5 mm. Change from baseline was computed as the value at Week 48 minus the baseline value. A positive value in change from Baseline indicates an improvement and a negative value indicates worsening.|Week 48|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had Schirmer's I test data at Baseline and Week 48. Data were not available for eight participants who received baminercept and one participant who received placebo.||mm/5 min||Standard Deviation|Mean
681603|NCT01552681|Secondary|Change From Baseline in Tear Secretion as Measured by Schirmer's I Test at Week 24|A paper strip was placed within each lower eyelid and the participant's eyes were closed for 5 minutes. The wet paper was removed after 5 minutes and the length of wetting was recorded to the nearest 0.5 mm. Change from baseline was computed as the value at Week 24 minus the baseline value. A positive value in change from Baseline indicates an improvement and a negative value indicates worsening.|Week 24|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had Schirmer's I test data at Baseline and Week 24. Data were not available for six participants who received baminercept and three participants who received placebo.||mm/5 min||Standard Deviation|Mean
681604|NCT01552681|Secondary|Change From Baseline in Patient and Physician Global Assessments of Disease Activity at Week 48|A participant's overall rating of Disease Activity and a physician's rating of the participant's disease activity. A vertical mark made on a 100 mm line rated 0 (no symptoms) to 100 (severe symptoms) determines the score. Change from baseline was computed as the value at Week 48 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening.|Week 48|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had Patient and Physician Global assessments of Disease Activity at Baseline and Week 48. Data were not available for six participants||mm||Standard Deviation|Mean
681677|NCT01552876|Secondary|Phase I: Number of Blinks Until Settled|Number of blinks for the right eye was counted until lens settling using headcam video.|Baseline to 5 minutes during Phase I|Subjects analyzed are those who were enrolled, randomized, and completed the study.||Blinks||Standard Error|Least Squares Mean
681605|NCT01552681|Secondary|Change From Baseline in Patient and Physician Global Assessments of Disease Activity at Week 24|A participant's overall rating of Disease Activity and a physician's rating of the participant's disease activity. A vertical mark made on a 100 mm line rated 0 (no symptoms) to 100 (severe symptoms) determines the score. Change from baseline was computed as the value at Week 24 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening.|Week 24|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had Patient and Physician Global assessments of Disease Activity at Baseline and Week 24. Data were not available for six participants||mm||Standard Deviation|Mean
681606|NCT01552681|Secondary|Change From Baseline in Patient Self-Assessment of Fatigue, Overall Dryness, and Joint Pain at Week 48|Three Visual Analog Scale (VAS) scores for patient self-assessment of symptoms of overall dryness, fatigue, and joint pain. On a 100-mm horizontal line the participant places a vertical mark to indicate responses to 3 questions. The range is 0 to 100, with 100 as the highest perceived tiredness, dryness, or joint pain. Change from baseline was computed as the value at Week 48 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening.|Week 48|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had VAS scores at Baseline and Week 48. Data were not available for five participants who received baminercept and one participant who received placebo.||mm||Standard Deviation|Mean
681607|NCT01552681|Secondary|Change From Baseline in Patient Self-Assessment of Fatigue, Overall Dryness, and Joint Pain at Week 24|Three Visual Analog Scale (VAS) scores for patient self-assessment of symptoms of overall dryness, fatigue, and joint pain. On a 100-mm horizontal line the participant places a vertical mark to indicate responses to 3 questions. The range is 0 to 100, with 100 as the highest perceived tiredness, dryness, or joint pain. Change from baseline was computed as the value at Week 24 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening.|Week 24|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had VAS scores at Baseline and Week 24. Data were not available for four participants who received baminercept and two participants who received placebo.||mm||Standard Deviation|Mean
681608|NCT01552681|Secondary|Change From Baseline in Visual Analog Scale (VAS) Scores for Sjogren's Syndrome Symptom Survey at Week 48|On a 100-mm horizontal line the participant places a vertical mark to indicate responses to 14 questions about salivary and ophthalmic function. The range is 0 to 100, with 100 as the highest perceived difficulty, dryness, discomfort, swelling, thirst, dryness, severity, or sensitivity. Change from baseline was computed as the value at Week 48 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening.|Week 48|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had VAS scores at Baseline and Week 48. Data were not available for five participants who received baminercept and one participant who received placebo.||mm||Standard Deviation|Mean
681609|NCT01552681|Secondary|Change From Baseline in Visual Analog Scale (VAS) Scores for Sjogren's Syndrome Symptom Survey at Week 24|On a 100-mm horizontal line the participant places a vertical mark to indicate responses to 14 questions about salivary and ophthalmic function. The range is 0 to 100, with 100 as the highest perceived difficulty, dryness, discomfort, swelling, thirst, dryness, severity, or sensitivity. Change from baseline was computed as the value at Week 24 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening.|Week 24|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had VAS results at Baseline and Week 24. Data were not available for four participants who received baminercept and two participants who received placebo.||mm||Standard Deviation|Mean
681610|NCT01552681|Secondary|Percent of Subjects Classified as Responders According to the Patient Self-Assessment of Fatigue, Overall Dryness, and Joint Pain at Week 48|Response is defined by 30% or more improvement (decrease) from baseline to week 48 in at least two of the three Visual Analog Scale (VAS) scores for patient self-assessment of symptoms of overall dryness, fatigue, and joint pain. On a 100-mm horizontal line the participant places a vertical mark to indicate a response. The range is 0 to 100, with 100 as the highest perceived overall fatigue, overall dryness, or joint pain.|Week 48|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had VAS results at Baseline and Week 48. Data were not available for five participants who received baminercept and one participant who received placebo.||Percent of participants|||Number
681611|NCT01552681|Secondary|Percent of Subjects Classified as Responders According to the Patient Self-Assessment of Fatigue, Overall Dryness, and Joint Pain at Week 24|Response is defined by 30% or more improvement (decrease) from baseline to week 24 in at least two of the three Visual Analog Scale (VAS) scores for patient self-assessment of symptoms of overall dryness, fatigue, and joint pain. On a 100-mm horizontal line the participant places a vertical mark to indicate a response. The range is 0 to 100, with 100 as the highest perceived overall fatigue, overall dryness, or joint pain.|Week 24|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had VAS results at Baseline and Week 24. Data were not available for four participants who received baminercept and one participant who received placebo.||Percent of participants|||Number
681624|NCT01553539|Primary|Antitumor Activity as Assessed by Number of Patients Showing an Objective Tumor Response|'Activity' will be operationalized using objective tumor response, which will be estimated as the proportion of partial and complete responders (according to Response Evaluation Criteria in Solid Tumors [RECIST] criteria) among all evaluable patients. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Approximately 1 year|||participants|||Number
681625|NCT01553318|Secondary|Change From Baseline in the Blood Levels of IL-8, MCP-1 and Eotaxin at Week 10|Change in peripheral blood levels of IL-8, MCP-1 and Eotaxin from baseline to week 10|baseline and week10|We do not have data on the chemokines because of the problems we had with the assays. Indeed, IL-8, MCP-1 and Eotaxin were all secondary outcomes.|||||
681612|NCT01552681|Secondary|Change From Baseline in European League Against Rheumatism (EULAR) Sjogren’s Syndrome Disease Activity Index (ESSDAI) at Week 24|The ESSDAI is a clinical index that measures Sjogren’s syndrome disease activity. A physician scores the disease activity level of twelve organ-specific domains in 3 or 4 levels according to their severity. For example, for no disease activity the domain score equals 0 and for high disease activity the domain score equals 3 or 4. Each domain is assigned a weight between 1 and 6, and the domain score is multiplied by the domain weight. The sum of the weighted domain scores is the overall score, which can range from 0 to 123. A higher score indicates more disease activity. Change from baseline was computed as the value at Week 24 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening.|Baseline to Week 24|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had an ESSDAI score at Baseline and Week 24. Data were not available for five participants who received baminercept and two participants who received placebo.||units on a scale||Standard Deviation|Mean
681613|NCT01552681|Secondary|Change From Screening in Unstimulated Whole Salivary Flow at Week 48|The participant spit into a preweighed 50-cm centrifuge tube for 15 minutes. The sample was weighed to determine the volume (1 g = 1 mL) of saliva. The volume of saliva (mL) was divided by the duration of the test (minutes) to calculate the unstimulated salivary flow rate (mL/min). Cholinergic stimulants such as pilocarpine or cevimeline were discontinued for 48 hours prior to the assessment and nothing was taken by mouth for 60 minutes or longer before or during saliva collection. Change from screening was computed as the value at Week 48 minus the screening value. A positive value in change from screening indicates an improvement and a negative value indicates worsening.|Screening to Week 48|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had unstimulated salivary flow results at Screening and Week 48. Data were not available for six participants who received baminercept and one participant who received placebo.||mL/min||Standard Deviation|Mean
681614|NCT01552681|Secondary|Change From Screening in Unstimulated Whole Salivary Flow at Week 24|The participant spit into a preweighed 50-cm centrifuge tube for 15 minutes. The sample was weighed to determine the volume (1 g = 1 mL) of saliva. The volume of saliva (mL) was divided by the duration of the test (minutes) to calculate the unstimulated salivary flow rate (mL/min). Cholinergic stimulants such as pilocarpine or cevimeline were discontinued for 48 hours prior to the assessment and nothing was taken by mouth for 60 minutes or longer before or during saliva collection. Change from screening was computed as the value at Week 24 minus the screening value. A positive value in change from screening indicates an improvement and a negative value indicates worsening.|Screening to Week 24|The Modified Intent-to-Treat with available data population included all randomized subjects who received >=1 dose of either baminercept or placebo and who had an unstimulated salivary flow assessment at screening and week 24. Data were not available for N=7 subjects (e.g., N=5 in baminercept and N=2 in placebo group).||mL/min||Standard Deviation|Mean
681615|NCT01552681|Secondary|Change From Screening in Stimulated Whole Salivary Flow at Week 48|After an unstimulated salivary flow assessment the participant was administered a single 5-mg dose of pilocarpine to stimulate saliva production. One hour after the administration of pilocarpine the participant spit into a preweighed 50-cm centrifuge tube for 15 minutes. The sample was weighed to determine the volume (1 g = 1 mL) of saliva. The volume of saliva (mL) was divided by the duration of the test (minutes) to calculate the stimulated salivary flow rate (mL/min). Change from screening was computed as the value at Week 48 minus the screening value. A positive value in change from screening indicates an improvement and a negative value indicates worsening.|Screening to Week 48|The Modified Intent-to-Treat with available data population included all randomized subjects who received >=1 dose of either baminercept or placebo and who had stimulated salivary flow results at screening and Week 48. Wk 48 stimulated salivary flow results were not available for N=7 subjects (e.g., N=6 in baminercept and N=1 in placebo group).||mL/min||Standard Deviation|Mean
681616|NCT01552681|Primary|Change From Screening in Stimulated Whole Salivary Flow at Week 24|After an unstimulated salivary flow assessment the participant was administered a single 5-mg dose of pilocarpine to stimulate saliva production. One hour after the administration of pilocarpine the participant spit into a preweighed 50-cm centrifuge tube for 15 minutes. The sample was weighed to determine the volume (1 g = 1 mL) of saliva. The volume of saliva (mL) was divided by the duration of the test (minutes) to calculate the stimulated salivary flow rate (mL/min). Change from screening was computed as the value at Week 24 minus the screening value. A positive value in change from screening indicates an improvement and a negative value indicates worsening.|Screening to Week 24|The Modified Intent-to-Treat population included all randomized subjects who received at least one dose of either baminercept or placebo with screening and post-screening stimulated salivary flow results. Participants missing Week 24 assessment were imputed from last post-screening assessment. Salivary flow results unavailable for one subject.||mL/min||Standard Deviation|Mean
681617|NCT01553708|Secondary|Clinical Safety of Epidermal Growth Factor With Silver Sulfadiazine Cream for Treatment of Partial Thickness Burn Wound.|"Pain and itching assessment is evaluated by patients themselves in every time of wound observations using Visual Analog Scale.
% Wound contraction.
Time and type of analgesic or itching medication after treatment.
Laboratory measurement such as CBC, blood glucose, electrolyte, hepatic and renal functions will be analyzed to find any changes or any systemic effect after treatment.
Adverse reaction such as swelling, edema and redness at wound site."|On 28th day after admission||||||
681618|NCT01553708|Primary|Time of Healing by Monitoring Duration (Days) at the Beginning of Treatment and the Day of Completely Epithelialization (Complete Epithelialization Means no Open Wound Exists as Confirmed by Two Surgeons).|Time (days)for complete epithelialization (no open wound exists as determined by 2 surgeons) is the duration between the day of admission and the wound completely close without fluid leakage and are able to expose to environment without pain.|On 28th day after admission|||Days||Standard Deviation|Mean
681619|NCT01553539|Secondary|Plasma Levels of Angiogenic Peptides Including PIGF||Day 22||||||
681620|NCT01553539|Secondary|Plasma Levels of Angiogenic Peptides Including Placental Growth Factor (PlGF)||Day 1||||||
681621|NCT01553539|Secondary|Overall Survival||Approximately 5 years||||||
681622|NCT01553539|Secondary|Time to Disease Progression||Approximately 5 years||||||
684442|NCT01516749|Secondary|Change in C-reactive Protein|Change assessed from baseline to end of treatment phase.|Baseline, 8 weeks|Patients who completed 8 weeks of therapy||mg/L||95% Confidence Interval|Mean
681633|NCT01553292|Secondary|Index After the Procedure|"The index is an arbitrary number calculated by equation that is author defined which is(FiO2 * CPAP/ Sat)*100.
FiO2: Fraction of inspired oxygen CPAP: continuous positive airway pressure Sat: saturation The equation is similar to the Oxygen index (OI) equation with replacement of Mean airway pressure (MAP) by continuous positive airway pressure (CPAP. It comprehensive view about the 3 parameters (FiO2, CPAP and Sat) during the procedure."|4 hours|The mean of ECALMIST index of all the participants after ECALMIST||Score||Standard Deviation|Mean
681634|NCT01553292|Secondary|Oxygen Saturation After the Procedure|Oxygen saturation is measured by pulse oximetry. It is express as proportion out of 1 (decimal) that is equal to percentage of 100. The number can be any where between 0.21 to 1 which is equal to percentage of 21 to 100.|4 hours|The mean of oxygen saturation after ECALMIST for all the participants||Proportion of oxygen saturation||Standard Deviation|Mean
681635|NCT01553292|Secondary|Oxygen Requirement Before the Procedure|Oxygen requirement or FiO2 (Fraction of inspired oxygen) is expressed as proportion out of one (decimal) or percentage of 100. The number can be any where between 0.21 to 1 which is equal to percentage of 21 to 100.|1 hour|The mean of oxygen requirement of all the participants before ECALMIST||Proportion of oxygen requirement||Standard Deviation|Mean
681636|NCT01553292|Secondary|CPAP Pressure After the Procedure|Continuous positive airway pressure (CPAP) is measured in centimeter of water|4 hours|The mean of CPAP pressure express as centimeter of water of all participants after completion of ECALMIST||Centimeter of water||Standard Deviation|Mean
681637|NCT01553292|Secondary|Index Before the Procedure|"The index is an arbitrary number calculated by equation that is author defined which is(FiO2 * CPAP/ Sat)*100.
FiO2: Fraction of inspired oxygen CPAP: continuous positive airway pressure Sat: saturation The equation is similar to the Oxygen index (OI) equation with replacement of Mean airway pressure (MAP) by continuous positive airway pressure (CPAP. It comprehensive view about the 3 parameters (FiO2, CPAP and Sat) during the procedure."|1 hour|The mean of index of all participants before ECALMIST||Score||Standard Deviation|Mean
681638|NCT01553292|Primary|Incidence of Early Ventilation Hours|The need for mechanical ventilation due to various reasons like sepsis, Apnea (pause of respiration for more than 20 seconds) or Respiratory dysfunction evidenced by abnormal blood gas or desaturation or increase work of breathing|72 hours|The number of preterm infants that need intubation by ETT within 72 hours of life(early ventilation). This is includes all infants intubated whether during or after the ECALMIST procedure in the 1st 3 days of life (after delivery)||Number of participants|||Number
681639|NCT01553292|Secondary|Failure to Catheterized the Trachea by the Vascular Catheter|Failure define as inability to pass the vascular catheter to the trachea after 2 trials within 20 seconds time frame for each trial.|20 seconds|Number of infatns that failed to pass the angiocath to the trachea after 2 trials, 20 seconds each trial.||Number of participants|||Number
681640|NCT01553292|Secondary|Saturation During the Procedure|Level of oxygen which is measured by oxygen pulse Oximetry. It is express as proportion out of one which is equal to percentage of 100. The number can be anywhere between 0.21 to 1 which is equal to percentage of 21 to 100.|10 minutes|The mean of oxygen saturation of all participants during ECALMIST(measured by minutes which is variable according participant tolerance of the ECALMIST procedure)||Proportion of oxygen saturation||Standard Deviation|Mean
681641|NCT01553292|Secondary|Incidence of Bradycardia During Procedure|Bradycardia is persistent heart rate below 100 beat per minute for more than 20 seconds during the procedure as seen by the monitor or Heart rate below 60 beat per minute for any time if chest compression is needed or if associated with desaturation or apnea.|Range of 10 minutes|The mean of heart beat per minute of all participants during ECALMIST(measured by minutes which is variable according participant tolerance of the ECALMIST procedure)||Number of participants|||Number
681642|NCT01553240|Secondary|Vineland Maladaptive Behavior Scale||during screening|P.I. has left the institution and NYSPI has no access to the data. Results will not be analyzed or presented.|||||
681643|NCT01553240|Primary|Repetitive Behavior Scale-revised||during screening|P.I. has left the institution and NYSPI has no access to the data. Results will not be analyzed or presented.|||||
681644|NCT01552954|Secondary|Systolic and Diastolic Blood Pressure Change Between Weeks 8 and 16|Change in Systolic and Diastolic Blood Pressure from Week 8 to Week 16 in the Intensive Education Group compared to the Conventional Education Group|week 8 and week 16|||mm Hg||Standard Deviation|Mean
681645|NCT01552954|Secondary|Na Excretion Change in 24 Hour-urine Collection Between Weeks 8 and 16|Change of sodium excretion rate in 24 hour-urine collection by intensive education for low salt diet at week 16|week 8 and week 16|||mEq/day||Standard Deviation|Mean
681646|NCT01552954|Secondary|∆Hemoglobin (0 Week - 16 Weeks)|The change of hemoglobin after prescription of Olmesartan|0 week, 16 weeks|||g/dL||Standard Deviation|Mean
681647|NCT01552954|Primary|∆Albuminuria by 24-hour Urine Protein Excretion|"Change in albuminuria as a 24-hour urine protein excretion by intensive education of low salt diet during taking olmesartan
*In outcome measure data table, the 24-hour urine collection at 16th week was omitted in 3 out of 245 patients (1 for intensive education group and 2 for conventional education group). Values of each study week were “mean” of all participants on specific study week, but “∆albuminuria (week 8 - week 16)” value was “mean” of ∆ values of “8 weeks-16 weeks” in each individuals. Therefore, values of 3 patients were excluded in “mean of ∆albuminuria (week 8 - week 16)”. That's why simple subtraction (week 8 - week 16) of values are not matched with the data."|changes from week 8 at week 16 (week 8 - week 16)|||mg/day||Standard Deviation|Mean
681648|NCT01552928|Primary|Mean Difference Changes From Baseline Versus Placebo in QT Intervals From Time-Matched Analysis by Largest Time Point|"The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value.
The largest time point refers to the estimated largest mean difference between each treatment and placebo among all time points. Values for different treatments can come from different time points."|Over 12 hours post-dose|Full Analysis Set (FAS) consists of subjects in the Safety Analysis Set who had at least 1 electrocardiogram (ECG). Safety Analysis Set consists of subjects who received at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||msec||90% Confidence Interval|Least Squares Mean
681678|NCT01552876|Secondary|Phase I: Time to Lens Settling|With random insertion and natural blinking, the slit lamp video was used to measure the time of lens settling.|5 minutes after lens insertion during Phase I|Subjects analyzed were those who were enrolled, randomized, and completed the study.||minutes||95% Confidence Interval|Least Squares Mean
681649|NCT01552928|Primary|Mean Difference Changes From Baseline Versus Placebo in QTcB Intervals From Time-Matched Analysis by Largest Time Point|"QT interval corrected for heart rate using Bazett's method (QTcB) at the subject-specific time of maximum plasma concentration. The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value.
The largest time point refers to the estimated largest mean difference between each treatment and placebo among all time points. Values for different treatments can come from different time points."|Over 12 hours post-dose|Full Analysis Set (FAS) consists of subjects in the Safety Analysis Set who had at least 1 electrocardiogram (ECG). Safety Analysis Set consists of subjects who received at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||msec||90% Confidence Interval|Least Squares Mean
681650|NCT01552928|Primary|Mean Difference Changes From Baseline Versus Placebo in QTcF Intervals From Time-Matched Analysis by Largest Time Point|"QT interval corrected for heart rate using Fridericia's method (QTcF) at the subject-specific time of maximum plasma concentration. The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value.
The largest time point refers to the estimated largest mean difference between each treatment and placebo among all time points. Values for different treatments can come from different time points."|Over 12 hours post-dose|Full Analysis Set (FAS) consists of subjects in the Safety Analysis Set who had at least 1 electrocardiogram (ECG). Safety Analysis Set consists of subjects who received at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||msec||90% Confidence Interval|Least Squares Mean
681651|NCT01552928|Primary|Mean Difference Changes From Baseline Versus Placebo in Heart Rate From Time-Matched Analysis by Largest Time Point|The largest time point refers to the estimated largest mean difference between each treatment and placebo among all time points. Values for different treatments can come from different time points.|Over 12 hours post-dose|Full Analysis Set (FAS) consists of subjects in the Safety Analysis Set who had at least 1 electrocardiogram (ECG). Safety Analysis Set consists of subjects who received at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||beats per minute||90% Confidence Interval|Least Squares Mean
681652|NCT01552928|Primary|Mean Difference Changes From Baseline Versus Placebo in QTcNi Intervals From Time-Matched Analysis by Largest Time Point|"QT interval corrected for heart rate using the subject-specific method (QTcNi) at the subject-specific time of maximum plasma concentration. The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value.
The largest time point refers to the estimated largest mean difference between each treatment and placebo among all time points. Values for different treatments can come from different time points."|Over 12 hours post-dose|Full Analysis Set (FAS) consists of subjects in the Safety Analysis Set who had at least 1 electrocardiogram (ECG). Safety Analysis Set consists of subjects who received at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||msec||90% Confidence Interval|Least Squares Mean
681653|NCT01552928|Secondary|Maximum Plasma Concentration (Cmax) of Metabolite of 2.5 mg Anagrelide (BCH24426) in Males and Females||Over 12 hours post-dose|Pharmacokinetic Analysis Set consists of all subjects in the Safety Analysis Set who had evaluable concentration-time profiles for anagrelide, BCH24426, or moxifloxacin.||ng/ml||Standard Deviation|Geometric Mean
681654|NCT01552928|Secondary|Maximum Plasma Concentration (Cmax) of Metabolite of 0.5 mg Anagrelide (BCH24426) in Males and Females||Over 12 hours post-dose|Pharmacokinetic Analysis Set consists of all subjects in the Safety Analysis Set who had evaluable concentration-time profiles for anagrelide, BCH24426, or moxifloxacin.||ng/ml||Standard Deviation|Geometric Mean
681655|NCT01552928|Secondary|Maximum Plasma Concentration (Cmax) of 2.5 mg Anagrelide in Males and Females||Over 12 hours post-dose|Pharmacokinetic Analysis Set consists of all subjects in the Safety Analysis Set who had evaluable concentration-time profiles for anagrelide, BCH24426, or moxifloxacin.||ng/ml||Standard Deviation|Geometric Mean
681656|NCT01552928|Secondary|Maximum Plasma Concentration (Cmax) of 0.5 mg Anagrelide in Males and Females||Over 12 hours post-dose|Pharmacokinetic Analysis Set consists of all subjects in the Safety Analysis Set who had evaluable concentration-time profiles for anagrelide, BCH24426, or moxifloxacin.||ng/ml||Standard Deviation|Geometric Mean
681657|NCT01552928|Secondary|Mean Difference Changes From Baseline Versus Placebo in QT Intervals at Subject-Specific Tmax|The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value.|Over 12 hours post-dose|Full Analysis Set (FAS) consists of subjects in the Safety Analysis Set who had at least 1 electrocardiogram (ECG). Safety Analysis Set consists of subjects who received at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||msec||90% Confidence Interval|Least Squares Mean
681658|NCT01552928|Secondary|Mean Difference Changes From Baseline Versus Placebo in QTcB Intervals at Subject-Specific Tmax|QT interval corrected for heart rate using Bazett's method (QTcB) at the subject-specific time of maximum plasma concentration. The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value.|Over 12 hours post-dose|Full Analysis Set (FAS) consists of subjects in the Safety Analysis Set who had at least 1 electrocardiogram (ECG). Safety Analysis Set consists of subjects who received at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||msec||90% Confidence Interval|Least Squares Mean
681659|NCT01552928|Secondary|Mean Difference Changes From Baseline Versus Placebo in QTcF Intervals at Subject-Specific Tmax|QT interval corrected for heart rate using Fridericia's method (QTcF) at the subject-specific time of maximum plasma concentration. The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value.|Over 12 hours post-dose|Full Analysis Set (FAS) consists of subjects in the Safety Analysis Set who had at least 1 electrocardiogram (ECG). Safety Analysis Set consists of subjects who received at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||msec||90% Confidence Interval|Least Squares Mean
681660|NCT01552928|Secondary|Mean Difference Changes From Baseline Versus Placebo in Heart Rate at Subject-Specific Tmax||Over 12 hours post-dose|Full Analysis Set (FAS) consists of subjects in the Safety Analysis Set who had at least 1 electrocardiogram (ECG). Safety Analysis Set consists of subjects who received at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||beats per minute||90% Confidence Interval|Least Squares Mean
681661|NCT01552928|Secondary|Mean Difference Changes From Baseline Versus Placebo in QTcNi Intervals at Subject-Specific Time of Maximum Plasma Concentration (Tmax)|QT interval corrected for heart rate using the subject-specific method (QTcNi) at the subject-specific time of maximum plasma concentration. The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value.|Over 12 hours post-dose|Full Analysis Set (FAS) consists of subjects in the Safety Analysis Set who had at least 1 electrocardiogram (ECG). Safety Analysis Set consists of subjects who received at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||msec||90% Confidence Interval|Least Squares Mean
681662|NCT01552915|Secondary|Change From Baseline in Pulse Rate at up to 8 Weeks - Last on Treatment Assessment||Baseline and up to 8 weeks|Safety Set: All randomized subjects who took at least 1 dose of investigational product.||bpm||Standard Deviation|Mean
681663|NCT01552915|Secondary|Change From Baseline in Diastolic Blood Pressure at up to 8 Weeks - Last on Treatment Assessment||Baseline and up to 8 weeks|Safety Set: All randomized subjects who took at least 1 dose of investigational product.||mmHg||Standard Deviation|Mean
681664|NCT01552915|Secondary|Change From Baseline in Systolic Blood Pressure at up to 8 Weeks - Last on Treatment Assessment||Baseline and up to 8 Weeks|Safety Set: All randomized subjects who took at least 1 dose of investigational product.||mmHg||Standard Deviation|Mean
681665|NCT01552915|Secondary|Percentage of Participants With Improvement on Clinical Global Impression - Global Improvement (CGI-I) at Week 8 - Last Observation Carried Forward (LOCF)|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|Week 8|Full Analysis Set: All subjects who took at least 1 dose of investigational product and who had at least 1 post-baseline primary efficacy assessment.||percentage of participants|||Number
681666|NCT01552915|Primary|Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale, Fourth Edition (ADHD-RS-IV) Total Score at Week 8|The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. Higher score indicates more severe symptoms.|Baseline and week 8|Full Analysis Set: All subjects who took at least 1 dose of investigational product and who had at least 1 post-baseline primary efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
681667|NCT01552902|Other Pre-specified|Change From Baseline in Pulse Rate at Week 6||Baseline, Week 6|Safety set. Not all Safety set participants were evaluable for this outcome measure.||Beats per minute||Standard Deviation|Mean
681668|NCT01552902|Other Pre-specified|Change From Baseline in Blood Pressure at Week 6||Baseline, Week 6|Safety set. Not all Safety set participants were evaluable for this outcome measure.||millimeter of mercury (mmHg)||Standard Deviation|Mean
681669|NCT01552902|Other Pre-specified|Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs|An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered as a pharmaceutical product that did not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were events between first dose of double-blind investigational product and up to 3 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to 3 days after last dose (last dose at Week 6)|Safety set.||participants|||Number
681670|NCT01552902|Secondary|Percentage of Participants With an Improvement on Clinical Global Impression - Global Improvement (CGI-I) at Week 6|The Clinical Global Impressions Scale permits a global evaluation of the participant's severity of illness and improvement over time. The scale included a severity of illness item and a global improvement item. The investigator performed the CGI-I to rate the improvement of a participant's ADHD symptoms based on a 7-point scale (1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; or 7=very much worse.). Percentage of participants with an improved measurement (response of very much improved and much improved) is reported.|Week 6|FAS.||percentage of participants|||Number
681671|NCT01552902|Primary|Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale, Fourth Edition (ADHD-RS-IV) Total Score at Week 6|The ADHD-RS-IV was developed to measure the behaviors of children with ADHD and is commonly used in clinical studies of ADHD. The ADHD-RS-IV consisted of 18 items designed to reflect current symptomatology of ADHD based on Diagnostic and Statistical Manual of Mental Disorders, 4th Edition-Text Revision (DSM-IV-TR) criteria. Each item was scored on a 4-point scale ranging from 0 (reflecting no symptoms) to 3 (reflecting severe symptoms) with total scores ranging from 0-54, Higher score = more severe symptoms.|Baseline, Week 6|Full Analysis Set (FAS) was defined as all participants in the Safety set who had at least 1 post-baseline measurement of the ADHD-RS-IV. Not all FAS participants were evaluable for this outcome measure.||units on a scale||Standard Error|Least Squares Mean
681672|NCT01552889|Secondary|PROMIS Physical Functioning Scale 10a Short Form|This is a 10 item questionnaire that assesses the respondent's ability to perform common physical activities as rated on a 1-5 scale. The total score is converted to a T score which expresses where the individual ranks relative to the reference group.|12 months|||units on a scale||Standard Deviation|Mean
681673|NCT01552889|Secondary|Treatment Satisfaction Scale.|This one item scale asks patients to rate their satisfaction with their depression treatment on a one (very dissatisfied) to 5 (very satisfied) scale.|12 months|||units on a scale||Standard Deviation|Mean
681674|NCT01552889|Primary|Beck Depression Inventory 2|Self report depression symptom inventory. Scale ranges from 0-63. The higher the score the more depression symptoms. A score of 12 or greater is considered to indicate a clinically significant depression.|12 months|||units on a scale||Standard Deviation|Mean
681675|NCT01552876|Other Pre-specified|Phase II: Absolute Rotation|Absolute rotation of the lens (degrees) at 1-minute post-fit on both eyes. Filcon II 3 lens was only used for comparison in phase II of the study per study protocol.|1-minute during Phase II|Analysis was on those subjects who were enrolled, randomized, and completed the study.||Degrees|Participants|Standard Deviation|Mean
681676|NCT01552876|Primary|Phase I: Absolute Lens Rotation|Lens orientation position as assessed on a scale of 0-180 on both eyes.|3 min after lens insertion during Phase I|Analysis was on those subjects who were enrolled, randomized, and completed the study.||Degrees|Participants|95% Confidence Interval|Least Squares Mean
681679|NCT01552876|Primary|Phase I: Absolute Lens Rotation|At 1-min after lens insertion, lens orientation position was assessed on a scale of 0-180 degree on both eyes.|At 1-min after lens insertion during Phase I|Subjects included in the analysis were those who were enrolled, randomized, and completed the study.||Degrees|Participants|95% Confidence Interval|Least Squares Mean
681680|NCT01552603|Secondary|Mean Deviation From Target Blood Glucose|Mean difference of venous blood glucose from glucose target. Daytime venous blood glucose values (7am-11pm) subtracted from daytime target of 115 mg/dl. Nighttime venous blood glucose values (11pm-7am) subtracted from nighttime target of 140 mg/dl. This is a metric of how successful the closed loop algorithm was at controlling glucose.|all 28 hour studies|||mg/dl||Standard Deviation|Mean
681681|NCT01552603|Primary|Mean Percent of Time in Target Blood Glucose Range|Mean percent of time venous blood glucose was sampled between 70-180 mg/dl|all 28 hour studies|||percentage of time||Standard Deviation|Mean
681682|NCT01552343|Secondary|Summary of Participants With Treatment-Emergent Adverse Events (TEAEs)|A TEAE was any adverse event occurring after start of treatment and within the time of residual drug effect, i.e. within one day of the last dose of desmopressin.|Day 1 up to 1 month|Safety analysis set||participants|||Number
681683|NCT01552343|Secondary|Minimum Post-Treatment Serum Sodium Levels|Serum sodium levels were monitored since hyponatremia is a potential serious adverse event associated with daily doses of desmopressin. A participant was to be withdrawn from the trial if the serum sodium level was <=125 mmol/L at any time.|Day 1 up to 1 month|Safety analysis set||participants|||Number
681684|NCT01552343|Secondary|Change From Baseline to Month 1 on Nocturia Impact (NI) Total Score|The NI Diary is a 12-item instrument consisting of 11 core items and an overall impact question (Q12). Responses are scored from 0 (no impact) to 4 (highest impact); the NI total score is the sum of the 11 core items scores (range of 0-44) which is then transformed to a 0-100 scale (high score indicates high impact). The NI total score was analyzable only if all 11 items (Q1-Q11) had non-missing responses. Otherwise, it was defined as missing. Missing values were not imputed. The average over the 3-day diary period prior to baseline (Day 1) and Month 1 was used for the overall impact score. Negative change from baseline scores indicate a decrease in impact caused by nocturia.|Baseline (Day -2 to Day 1), Treatment (Day 28-30)|Full analysis set. The study is a psychometric evaluation of a new PRO tool and is not designed to show treatment difference between active and placebo.||units on a scale||Standard Deviation|Mean
681685|NCT01552343|Secondary|Construct Validity For the Nocturia Impact (NI) Total Scores and Overall Impact Question (Q12) for Participants With High/Low Number of Nocturnal Voids|"The known group validity was assessed by comparing participants who experienced ≥3 nocturnal voids to those who experienced <3 nocturnal voids, using the average over 3 days for the Screening and Baseline diaries. Results are reported for the NI Total Scores and the Overall Impact Question (Q12).
The NI Diary is a 12-item instrument consisting of 11 core items and an overall impact question (Q12). The NI total score is defined as the sum of the 11 core items scores.
The overall impact question (Q12) and the NI total score were transformed using Fisher's z transformation, i.e. the scores were based on a standardized scale from 0 (lowest impact) to 100 (highest impact)."|Screening (Day -20), Baseline (Day 1)|Full analysis set. Study results are reported as per the pre-planned statistical analysis plan on combined treatment groups. The study is a psychometric evaluation of a new PRO tool and is not designed to show treatment difference between active and placebo.||units on a scale||Standard Deviation|Mean
681686|NCT01552343|Secondary|Internal Consistency of the Nocturia Impact (NI) Total Score for Each Day NI Diaries Were Completed Assessed as Cronbach's Alpha Values|"Cronbach’s alpha (CA) is a measure of the internal consistency of the Nocturia Impact (NI) Total scores. Higher scores indicate a more reliable (precise) instrument. A value of 0.70 set as the benchmark for declaring the scale as internally consistent.
Cronbach's alpha was assessed for each of the three consecutive days NI diaries were completed during screening (Day -20 to Day -18), baseline (Day -2 to Day 1) and Month 1 (Day 28 to Day 30)."|Screening (Day -20 to Day -18), Baseline (Day -2 to Day 1) and Treatment (Day 28 to Day 30)|Full analysis set. Study results are reported as per the pre-planned statistical analysis plan on combined treatment groups. The study is a psychometric evaluation of a new PRO tool and is not designed to show treatment difference between active and placebo.||ratio of variance||95% Confidence Interval|Number
681687|NCT01552343|Primary|Cohen's D Effect Size in Responsiveness in the Nocturia Impact (NI) Total Scores and Overall Impact Question as Measured From Baseline (Day 1) to Month 1|"The responsiveness of the NI Diary was measured with Cohen’s D effect size. The effect size was calculated for active treatment versus placebo, based on change from Baseline to Month 1. The effect size was evaluated as “small,” “medium,” or “large” if D was <=0.35, >0.35 - 0.65, or >0.65, respectively.
Mean values are the Cohen's D effect size. Standard deviation is the pooled standard deviation."|Day 1 (Baseline), Month 1|Full analysis set. Study results are reported as per the pre-planned statistical analysis plan on combined treatment groups. The study is a psychometric evaluation of a new PRO tool and is not designed to show treatment difference between active and placebo.||units on a scale||Standard Deviation|Mean
681688|NCT01552343|Primary|Difference in Mean Change From Baseline to Month 1 in Nocturia Impact (NI) Total Scores and Overall Impact Question for Responders and Non-Responders|"This outcome is a measure of sensitivity of the NI Diary to change in nocturia.
The NI Diary is a 12-item instrument consisting of 11 core items and an overall impact question (Q12). The NI total score is defined as the sum of the 11 core items scores.
The overall impact question (Q12) and the NI total score were transformed using Fisher's z transformation, i.e. the scores were based on a standardized scale from 0 (lowest impact) to 100 (highest impact).
The difference in mean change in NI total score for subjects who experienced a reduction from baseline of <33% in nocturnal voids at the Month 1 visit (non-responders) versus those with a reduction in nocturnal voids from Baseline of ≥33% (responders) was estimated."|Day 1 (Baseline), Month 1|Full analysis set. Study results are reported as per the pre-planned statistical analysis plan on combined treatment groups. The study is a psychometric evaluation of a new PRO tool and is not designed to show treatment difference between active and placebo.||units on a scale||Standard Deviation|Mean
681711|NCT01551888|Secondary|Area Under the Formoterol Plasma Concentration Versus Time Curve (AUC) Over Dosing Interval Following a Single Dose|The standard deviation of the measure is expressed as the coefficient of variation (%)|Day 1: 0, 5, 15 and 30 min and 1, 1.5, 2, 3, 4, 6, 8, and 12 hours (5 min before PM dose) and 5 and 15 min post PM dose|The pharmacokinetic (PK) analysis population included all patients who completed the study and had evaluable PK parameters||pg*hr/mL||Standard Deviation|Mean
681689|NCT01552343|Primary|The Pearson Correlation Coefficient Between Change From Baseline to Month 1 in Number of Nocturnal Voids and Change From Baseline to Month 1 in Nocturia Impact (NI) Diary Total Score|"This outcome is a measure of sensitivity of the NI Diary to change in nocturia.
The NI Diary is a 12-item instrument consisting of 11 core items and an overall impact question (Q12). Responses are scored from 0 (no impact) to 4 (highest impact); a lowering of score equals a decrease in impact caused by nocturia. The NI total score is the sum of the 11 core items scores. The NI total score was analyzable only if all 11 items (Q1-Q11) had non-missing responses. Otherwise, it was defined as missing. Missing values were not imputed. The average over the 3-day diary period prior to baseline (Day 1) and Month 1 was used for the overall impact score.
The correlation was estimated using Fisher’s z transformation, i.e. the NI total score was based on a standardized scale from 0 (lowest impact) to 100 (highest impact).
Corresponding adjusted partial correlation coefficients were based on adjustments for mean number of Baseline voids, Baseline NI total score, age, and gender."|Day 1 (Baseline), Month 1|Full analysis set. Study results are reported as per the pre-planned statistical analysis plan on combined treatment groups. The study is a psychometric evaluation of a new PRO tool and is not designed to show treatment difference between active and placebo.||correlation coefficient||95% Confidence Interval|Number
681690|NCT01552057|Primary|Change From Baseline up to 14-Week Endpoint in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (ANCOVA)|BPI 24-hour average pain severity is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. Severity scores ranged from 0 (no pain) to 10 (severe pain). LS mean was calculated using an analysis of covariance (ANCOVA) approach including administration groups as fixed effects, and BPI average pain severity at baseline and the presence or absence of major depressive disorder as covariates.|Baseline, up to 14 weeks|Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity); Last Observation Carried Forward (LOCF) values were used.||units on a scale||Standard Error|Least Squares Mean
681691|NCT01552057|Primary|Change From Baseline to 10 Weeks in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM)|BPI 24-hour average pain severity is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. Severity scores ranged from 0 (no pain) to 10 (severe pain). LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and BPI average pain severity at baseline and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.|Baseline, 10 weeks|Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).||units on a scale||Standard Error|Least Squares Mean
681692|NCT01552057|Primary|Change From Baseline to 6 Weeks in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM)|BPI 24-hour average pain severity is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. Severity scores ranged from 0 (no pain) to 10 (severe pain). LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and BPI average pain severity at baseline and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.|Baseline, 6 weeks|Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).||units on a scale||Standard Error|Least Squares Mean
681693|NCT01552057|Primary|Change From Baseline to 4 Weeks in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM)|BPI 24-hour average pain severity is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. Severity scores ranged from 0 (no pain) to 10 (severe pain). LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and BPI average pain severity at baseline and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.|Baseline, 4 weeks|Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).||units on a scale||Standard Error|Least Squares Mean
681694|NCT01552057|Primary|Change From Baseline to 2 Weeks in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM)|BPI 24-hour average pain severity is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. Severity scores ranged from 0 (no pain) to 10 (severe pain). LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and BPI average pain severity at baseline and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.|Baseline, 2 weeks|Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).||units on a scale||Standard Error|Least Squares Mean
681695|NCT01552057|Secondary|Change From Baseline to 14-Week Endpoint in Brief Pain Inventory-Severity (BPI-S) and Brief Pain Inventory-Interference (BPI-I) Scores on the BPI-Modified Short Form|BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function, respectively. Severity scores ranged from 0 (no pain) to 10 (severe pain) for each question assessing worst pain, least pain, and pain right now. Interference scores ranged from 0 (does not interfere) to 10 (completely interferes) for each question assessing interference of pain in past 24 hours with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference was the average of non-missing scores of individual interference items. LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and baseline as well as the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.|Baseline, 14 weeks|Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).||units on a scale||Standard Error|Least Squares Mean
686659|NCT01487577|Secondary|Pharmacokinetic Analysis of MMF AUC to Evaluate MMF Dose Relationships to Drug Exposure.|Pharmacokinetic analysis includes, but is not limited to, area under the plasma concentration versus time curve (AUC).|100 days|||mcg*hr/mL||Full Range|Median
681696|NCT01552057|Secondary|Change From Baseline to 14-Week Endpoint in Average Pain and Worst Pain Severity Score Within 24-Hours in Participant Diary|Each morning participants rated their average pain and worst pain within the past 24 hours on separate 11-point Likert scales with scores ranging from 0 (no pain) through 10 (worst possible pain). These scores were then averaged for the week and compared to baseline. LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and baseline as well as the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.|Baseline, 14 weeks|Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).||units on a scale||Standard Error|Least Squares Mean
681697|NCT01552057|Secondary|Change From Baseline to 14-Week Endpoint in Widespread Pain Index (WPI) and Symptom Severity (SS) in American College of Rheumatology (ACR) Fibromyalgia Diagnostic Criteria 2010|WPI: Participant-reported areas (out of 19 points on the body) in which the participant had pain in the past week. WPI scores ranged from 0 (no areas) to 19 (all areas). SS: The sum of severity scores for fatigue, waking unrefreshed, and cognitive symptoms [each rated from 0 (no problem) to 3 (severe; life-disturbing problems)] plus the severity of somatic symptoms in general [rated from 0 (no symptoms) to 3 (a great deal of symptoms)]. The total SS score ranged from 0 and 12. LS mean was calculated using an MMRM approach including administration groups, observation points, interaction between the administration groups and the observation points as fixed effects, and baseline as well as the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.|Baseline, 14 weeks|Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).||units on a scale||Standard Error|Least Squares Mean
681698|NCT01552057|Secondary|Change From Baseline to 14-Week Endpoint in Beck Depression Inventory-II (BDI-II)|The BDI-II is a 21-item self-administered questionnaire designed to assess the characteristics of depression. Each item was scored on a 4-point scale ranging from 0 (not present) to 3 (present in the extreme) and was summed to give a total BDI-II score. A total BDI-II score of 0 through 13 was considered minimal, 14 through 19 was mild, 20 through 28 was moderate, and 29 through 63 was severe depression symptoms. LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups and as fixed effects, and baseline as well as the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.|Baseline, 14 weeks|Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).||units on a scale||Standard Error|Least Squares Mean
681699|NCT01552057|Secondary|Change From Baseline to 14-Week Endpoint in 36-Item Short-Form (SF-36) Health Survey Domain Scores|The SF-36 Health Survey is a generic, health-related survey assessing the participant’s quality of life on 8 domains: physical functioning, daily functioning (physical), bodily pain, general health, vitality, social functioning, daily functioning (emotional), and mental health. Each domain was scored by summing individual items pertaining to that domain and transforming scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. LS mean was calculated using an ANCOVA approach including administration groups as fixed effects, and baseline as well as the presence or absence of complication by major depressive disorder as covariates.|Baseline, up to 14 weeks|Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity); LOCF values were used.||units on a scale||Standard Error|Least Squares Mean
681700|NCT01552057|Secondary|Change From Baseline to 14-Week Endpoint in Fibromyalgia Impact Questionnaire (FIQ)|FIQ is a 20-item, self-administered questionnaire using Likert-type scales to measure participant (pt) outcomes over the past week. Items 1 through 11 measured physical functioning on 4-point scales. Items 12 and 13 measured the number of days a pt felt well and days a pt was unable to work due to fibromyalgia symptoms. Items 14 through 20 were 11-point scales on which a pt rated work difficulty, pain, fatigue, morning tiredness, stiffness, anxiety, and depression. If a pt did not do all the tasks listed, those items were deleted from scoring. Algorithms were used to determine total FIQ scores which ranged from 0 to 100; higher scores indicated a more negative impact. LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between administration groups as fixed effects, and baseline as well as the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.|Baseline, 14 weeks|Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).||units on a scale||Standard Error|Least Squares Mean
681701|NCT01552057|Secondary|Clinical Global Impression of Improvement (CGI-I) at Endpoint|CGI-I measures the clinician's perception of participant improvement at the time of assessment (compared with the start of treatment). Scores ranged from 1 (very much better) to 7 (very much worse). LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.|14 weeks|Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).||units on a scale||Standard Error|Least Squares Mean
681702|NCT01552057|Secondary|Patients Global Impression of Improvement (PGI-I) at Endpoint|PGI-I measures the participant's perception of improvement at the time of assessment compared with the start of treatment. Scores ranged from 1 (very much better) to 7 (very much worse). LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.|14 weeks|Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).||units on a scale||Standard Error|Least Squares Mean
681767|NCT01551056|Secondary|Ciliary Redness at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Ciliary Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ciliary redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT) with observed data only.||units on a scale||Standard Deviation|Mean
681703|NCT01552057|Primary|Change From Baseline to 14-Week Endpoint in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM)|BPI 24-hour average pain severity is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. Severity scores ranged from 0 (no pain) to 10 (severe pain). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and BPI average pain severity at baseline and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.|Baseline, 14 weeks|Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).||units on a scale||Standard Error|Least Squares Mean
681704|NCT01551979|Secondary|Change From Baseline on the Calgary Depression Scale for Schizophrenia|The Calgary Depression Scale for Schizophrenia is a 9-item scale that assesses depressive symptoms in patients with schizophrenia. Each item is rated separately and ratings range from 0 to 3. Higher values represent more severe depressive symptoms: 0 indicates an absent symptom and 3 indicates a severe symptom. The overall Calgary Depression Scale score is computed by summing each item. The total Calgary Depression Scale score ranges from 0 to 27, with higher values representing more severe depression in patients with schizophrenia. Change from baseline on the Calgary Depression Scale can range from -27 to +27, with negative values representing an improvement in depressive symptoms and positive values representing worsening depressive symptom severity. Depression was assessed at baseline, after 5 days of treatment, 1 week post treatment, and 3 weeks post treatment.|Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment|Participant drop out||units on a scale||Standard Deviation|Mean
681705|NCT01551979|Primary|Clinical Global Impression (CGI) Global Improvement|Treatment response was evaluated with the Clinical Global Impressions (CGI) Scale, which is comprised of two companion one-item measures that use 7-point scales to evaluate severity of psychopathology and improvement from the initiation of treatment; each component is rated separately and the CGI does not yield a global score. The CGI Global Improvement is a 7-point subscale in which a clinician assesses how much a patient’s illness has changed compared to baseline. Ratings range from 1 to 7, with 1 indicating very much improved and 7 indicating very much worse. Change from baseline on the CGI Global Improvement subscale can range from -6 to +6, with negative values representing an improvement in psychopathology and positive values representing worsening psychopathology. Global Improvement was assessed after 5 days of treatment, 1 week post treatment, and 3 weeks post treatment.|Last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment|Participant drop out||units on a scale||Standard Deviation|Mean
681706|NCT01551979|Primary|Change From Baseline on the Clinical Global Impression (CGI) Severity of Illness|Treatment response was evaluated with the Clinical Global Impressions (CGI) Scale, which is comprised of two companion one-item measures that use 7-point scales to evaluate severity of psychopathology and improvement from the initiation of treatment; each component is rated separately and the CGI does not yield a global score. The CGI Severity of Illness is a 7-point subscale in which a clinician rates the severity of the patient’s illness at the time of assessment. Ratings range from 1 to 7 and higher values represent more severe psychopathology: 1 indicates a normal and not at all ill patient and 7 indicates among the most extremely ill patients. Change from baseline on the CGI Severity of Illness subscale can range from -6 to +6, with negative values representing an improvement in psychopathology and positive values representing worsening psychopathology. Severity of Illness was assessed at baseline, after 5 days of treatment, 1 week post treatment, and 3 weeks post treatment.|Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment|Participant drop out||units on a scale||Standard Deviation|Mean
681707|NCT01551979|Primary|Change From Baseline on the Positive and Negative Syndrome Scale (PANSS) General Subcale|Therapeutic efficacy was evaluated with the Positive and Negative Syndrome Scale (PANSS) General Subscale, a 16 item subscale measuring the presence/absence and severity of general psychopathology of schizophrenia. The minimum score is 16 and the maximum score is 112, with higher values representing greater psychopathology severity. Change from baseline on the PANSS General Subscale can range from -96 to +96; negative values represent an improvement in symptom severity, and positive values represent worsening symptom severity. Therapeutic efficacy was assessed at baseline, after 5 days of treatment, 1 week post treatment, and 3 weeks post treatment.|Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment|Participant drop out||units on a scale||Standard Deviation|Mean
681708|NCT01551979|Primary|Change From Baseline on the Positive and Negative Syndrome Scale (PANSS) Negative Subscale|Therapeutic efficacy was evaluated with the Positive and Negative Syndrome Scale (PANSS) Negative Subscale, a 7 item subscale measuring the presence/absence and severity of negative symptoms of schizophrenia. The minimum score is 7 and the maximum score is 49, with higher values representing greater symptom severity. Change from baseline on the PANSS Negative Subscale can range from -42 to +42; negative values represent an improvement in symptom severity, and positive values represent worsening symptom severity. Therapeutic efficacy was assessed at baseline, after 5 days of treatment, 1 week post treatment, and 3 weeks post treatment.|Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment|Participant drop out||units on a scale||Standard Deviation|Mean
681709|NCT01551979|Primary|Change From Baseline on the Positive and Negative Syndrome Scale (PANSS) Positive Subcale|Therapeutic efficacy was evaluated with the Positive and Negative Syndrome Scale (PANSS) Positive Subscale, a 7 item subscale measuring the presence/absence and severity of positive symptoms of schizophrenia. The minimum score is 7 and the maximum score is 49, with higher values representing greater symptom severity. Change from baseline on the PANSS Positive Subscale can range from -42 to +42; negative values represent an improvement in symptom severity, and positive values represent worsening symptom severity. Therapeutic efficacy was assessed at baseline, after 5 days of treatment, 1 week post treatment, and 3 weeks post treatment.|Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment|Participant drop out||units on a scale||Standard Deviation|Mean
681710|NCT01551888|Primary|Maximum Formoterol Plasma Drug Concentration (Cmax) Following a Single Dose|The standard deviation of the measure is expressed as the coefficient of variation (%)|Day 1: 0, 5, 15 and 30 min and 1, 1.5, 2, 3, 4, 6, 8, and 12 hours (5 min before PM dose) and 5 and 15 min post PM dose|The pharmacokinetic (PK) analysis population included all patients who completed the study and had evaluable PK parameters||pg/mL||Standard Deviation|Mean
681712|NCT01551888|Primary|Maximum Formoterol Plasma Drug Concentration (Cmax) at Steady State|The standard deviation of the measure is expressed as the coefficient of variation (%)|Day 1: 0, 5, 15 and 30 min and 1, 1.5, 2, 3, 4, 6, 8, and 12 hours (5 min before PM dose) and 5 and 15 min post PM dose; Days 2-4: 0, 5 and 15 min post dose; Day 5: 0, 5, 15 and 30 min and 1, 1.5, 2, 3, 4, 6, 8, and 12 hours (post AM dose)|The pharmacokinetic (PK) analysis population included all patients who completed the study and had evaluable PK parameters||pg/mL||Standard Deviation|Mean
681713|NCT01551888|Primary|Area Under the Formoterol Plasma Concentration Versus Time Curve (AUC) Over Dosing Interval at Steady State|The standard deviation of the measure is expressed as the coefficient of variation (%)|Day 1: 0, 5, 15 and 30 min and 1, 1.5, 2, 3, 4, 6, 8, and 12 hours (5 min before PM dose) and 5 and 15 min post PM dose; Days 2-4: 0, 5 and 15 min post dose; Day 5: 0, 5, 15 and 30 min and 1, 1.5, 2, 3, 4, 6, 8, and 12 hours (post AM dose)|The pharmacokinetic (PK) analysis population included all patients who completed the study and had evaluable PK parameters||pg*hr/mL||Standard Deviation|Mean
681714|NCT01551758|Secondary|Number of Participants With Serious Adverse Drug Reactions|A serious adverse drug reactions (SADR) is any untoward medical occurrence suspected to be medicinal product-related that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.|Upto 12 months|ITT Population||Participants|||Number
681715|NCT01551758|Secondary|Number of Participants With Serious Adverse Events|SAEs assessed included medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a significant medical event in the investigator's judgment, or is an event of possible drug-induced liver injury with hyperbilirubinaemia. SAEs were includes if the onset date was on or after the treatment start date and on or before the treatment stop date. However, the window for an SAE of pneumonia was longer and included 28 days post study treatment stop date.|Up to 56 weeks|ITT Population||Participants|||Number
681716|NCT01551758|Secondary|Number of Participants With Non-serious Adverse Drug Reactions (ADR)|The number of participants with non-serious ADRs was assessed for up to 54 weeks. An ADR is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, for which there is a reasonable possibility that the untoward occurrence is causally related to the medicinal product. A non-serious ADR included one of the following: exacerbation of chronic or intermittent pre-existing condition; signs, symptoms, or the clinical sequelae of a suspected interaction; signs, symptoms, or new conditions detected or diagnosed after study treatment administration.|Up to 54 weeks|ITT Population||Participants|||Number
681717|NCT01551758|Secondary|Number of Participants With Fatal Serious Adverse Events of Pneumonia|All SAEs included in the AE subgroup of special interest of “pneumonia” were considered as an SAE of pneumonias. A fatal SAE was defined as a SAE with outcome of fatal for study participant. The number of participants with fatal SAEs of pneumonia was assessed over 14 months.|Upto 58 weeks|ITT Population||Participants|||Number
681718|NCT01551758|Secondary|Time to First Severe Exacerbations Occurring in a Year|"The date of an event for severe exacerbation was defined as the exacerbation onset date. Participants who completed the study without a severe exacerbation were censored. The analysis method was a Cox proportional hazards model adjusted for randomized treatment.
The probability of first severe exacerbation was measured from the date of randomisation (i.e., treatment initiation) to the onset date of first severe exacerbation, as recorded on eCRF, or date of treatment termination (Visit 6 or early withdrawal visit) for participants who completed the study without any severe exacerbations (censored). At Day 364, all participants who have not experienced a severe exacerbation are considered censored, regardless of whether their on-treatment phase continues beyond day 364, including those who withdrew early. Number of participants with event is presented."|Up to 364 days|ITT Population||Participants|||Number
681719|NCT01551758|Secondary|Time to First Moderate/Severe Exacerbations on Initial Therapy Occurring in a Year|The date of an event for moderate / severe COPD exacerbation was defined as the exacerbation onset date. The analysis method was a Cox proportional hazards model adjusted for randomized treatment. The probability of first moderate / severe exacerbation on initial therapy was measured from the date of randomisation (i.e., exposure start date) to the onset date of first moderate or severe COPD exacerbation, or to the date of discontinuation of initial therapy (analysis was censored at date of discontinuation of initial therapy) for participants who completed the study without any moderate or severe exacerbations on initial therapy. Number of participants with event is presented.|Up to 364 days|ITT Population||Participants|||Number
681720|NCT01551758|Secondary|Time to First Moderate/Severe Exacerbations Occurring in a Year|The date of an event for moderate / severe COPD exacerbation was defined as the exacerbation onset date. The analysis method was a Cox proportional hazards model adjusted for randomized treatment. The probability of a first moderate / severe exacerbation was measured from the date of randomisation (i.e., treatment initiation) to the onset date of first moderate or severe COPD exacerbation, as recorded on eCRF, or date of treatment termination (Visit 6 or early withdrawal visit) for participants who completed the study without any moderate or severe exacerbations (censored). Participants who completed the study without a moderate or severe COPD exacerbation and analyses of time to first moderate/severe exacerbation were censored at Day 364. Number of participants with event is presented.|Up to 364 days|ITT Population||Participants|||Number
681721|NCT01551758|Secondary|Time to the Addition of a Further COPD Controller Medication Occurring in a Year|The date of an event for addition of a further COPD controller medication was defined as the exposure start date of the first modified treatment medication that included a new COPD maintenance therapy of a new class of drug (to the initial therapy) during the study treatment period, as collected on the investigational product page of the eCRF. Participants who did not add any COPD controller medication during the study were censored at the end of the treatment period (Day 364). This was equivalent to stepping up, defined as the addition of at least one new class of drug. The probability of an event was measured from the date of randomisation (i.e., treatment initiation) to the date of a change event. The analysis method was a Cox proportional hazards model adjusted for randomized treatment. Number of participants with event is presented.|Up to 364 days|ITT Population||Participants|||Number
686660|NCT01487577|Secondary|Number of Participants in Overall Survival.||1 year|||participants|||Number
686661|NCT01487577|Secondary|Number of Participants Who Experienced Nonrelapse Mortality.||1 year|||participants|||Number
681722|NCT01551758|Secondary|Time to an Event of Discontinuation of Initial Therapy Occurring in a Year|Initial therapy was defined as the treatment that the subject was randomised to at randomisation. Discontinuation of initial therapy was defined as any modification of initial therapy. These included stepping up, stepping down or switching to another class/class combination, or withdrawal from the study. Switching within the same drug class did not count unless participant switched from FF/VI to a different ICS/LABA. The analysis method was a Cox proportional hazards model adjusted for randomized treatment. The probability of discontinuation of initial therapy was measured from the date of randomisation (i.e., exposure start date) to the date of discontinuation of initial therapy to which the participant was randomized, or date of treatment termination (Visit 6 or early withdrawal visit) for participants who completed the study without discontinuing the initial therapy (censored). Number of participants with event is presented.|Up to 364 days|ITT Population||Participants|||Number
681723|NCT01551758|Secondary|Number of All Primary Care Contacts Expressed Using Least Square Mean|A primary care contact was defined as contact with a either a nurse, general practitioner, or other healthcare professional. The analysis method was General Linear Model assuming an underlying negative binomial distribution with a log-link function and logarithm of time on treatment as an offset variable and adjusted for randomised treatment, baseline COPD maintenance therapy per randomisation stratification, number of moderate/severe COPD exacerbations in the previous year to randomisation and smoking status at baseline.|Up to 54 weeks|ITT Population.||Contacts per participant per year||95% Confidence Interval|Least Squares Mean
681724|NCT01551758|Secondary|Number of All Secondary Care Contacts Expressed Using Least Square Mean|A secondary care contact was defined as an inpatient admission or a specialist outpatient visit or an A&E contact. A participant with an A&E contact and subsequent inpatient admission was considered to have had two healthcare contacts. In the situation where inpatient admissions were recorded at two hospitals on the same day, this was counted as a single secondary care contact. The analysis method was General Linear Model assuming an underlying negative binomial distribution with a log-link function and logarithm of time on treatment as an offset variable and adjusted for randomised treatment, baseline COPD maintenance therapy per randomization stratification, number of moderate/severe COPD exacerbations in the previous year to randomization and smoking status at baseline.|Up to 54 weeks|ITT Population.||Contacts per participant per year||95% Confidence Interval|Least Squares Mean
681725|NCT01551758|Secondary|Number of COPD-related Primary Care Contacts Expressed Using Least Square Mean|A COPD-related primary care contact was defined as a primary care contact on a given calendar date with either a nurse, general physician (GP) or other healthcare professional that were considered as COPD-related, if the most prominent signs and symptoms the participant was presenting were as a direct result of the participant's COPD, as per Readcodes recorded in the patients electronic health record (EHR). The analysis method was General Linear Model assuming an underlying negative binomial distribution with a log-link function and logarithm of time on treatment as an offset variable and adjusted for randomised treatment, baseline COPD maintenance therapy per randomisation stratification, number of moderate/severe COPD exacerbations in the previous year to randomisation and smoking status at baseline.|Up to 54 weeks|ITT Population.||Contacts per participant per year||95% Confidence Interval|Least Squares Mean
681726|NCT01551758|Secondary|Number of COPD-related Secondary Care Contacts Expressed as Least Square Mean|A COPD-related secondary care contact was defined as an inpatient admission or a specialist outpatient visit or an accident & emergency (A&E) contact. A participant with an A&E contact and subsequent inpatient admission was considered to have had two healthcare contacts. Inpatient admissions recorded at two hospitals on the same day, this was counted as a single (inpatient admission) secondary care contact. COPD-related contacts were identified using predefined lists of ICD-10 codes, specialty descriptions and diagnosis codes recorded in the patients electronic health record (EHR). GLM assuming the negative binomial distribution with log-link function and logarithm of time on treatment as an offset variable and adjusted for randomised treatment, baseline COPD maintenance therapy per randomisation stratification, number of moderate/severe COPD exacerbations in the previous year to randomisation and smoking status at baseline.|Up to 54 weeks|ITT Population.||Contacts per participant per year||95% Confidence Interval|Least Squares Mean
681727|NCT01551758|Secondary|Time to the First Serious Adverse Event of Pneumonia Occuring in a Year|The analysis method was a Cox proportional hazards model adjusted for randomized treatment. Analyses included those on-treatment SAEs of pneumonia that had an onset over the first 364 days of exposure, as defined. Participants who did not have an SAE of pneumonia during the first 364 days of the treatment period (start date of exposure to end date of exposure + 28 days were considered censored. Number of participants with event is presented.|Up to 52 weeks|ITT Population||Participants|||Number
681728|NCT01551758|Secondary|Mean Number of Serious Adverse Events of Pneumonia During the Study|The mean number of SAE of pneumonia over the treatment period (from first date of exposure to last date of exposure + 28 days was calculated. Analysis was performed using a negative binomial regression model with covariates of randomised treatment and with logarithm of time on treatment as an offset variable.|Up to 58 weeks|ITT Population.||Mean Number of SAE||95% Confidence Interval|Least Squares Mean
681729|NCT01551758|Secondary|Number of Participants With Serious Adverse Events (SAEs) of Pneumonia During the Study|Incidence of SAE of pneumonia was defined for each randomized treatment group as the proportion (number) of participants in that group who experienced at least one SAE of pneumonia in the Pneumonia Adverse Event of Special Interest subgroup during the treatment period (from start date of exposure to stop date of exposure + 28 days). Non-inferiority is demonstrated if the upper limit of the two-sided 95% confidence interval for the incidence ratio is less than 2. Serious Adverse Events of pneumonia are defined by the Pneumonia Special Interest Group, which for SAEs of pneumonia collected for these subjects includes the following preferred terms: Pneumonia, Pneumonia aspiration, Aspergillus infection, Empyema, Pneumonia streptococcal, Pneumonitis, Pulmonary tuberculosis.|Up to 58 weeks|The Intent-to-Treat (ITT) Population: Defined as all participants who were randomised and received at least one prescription of study medication||Participants|||Number
681768|NCT01551056|Secondary|Ciliary Redness at Duration of Action (16 Hours + 1 Hour Post-dose)|A treatment efficacy CAC was performed 16 hours + 1 hour after drop instillation. Ciliary Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ciliary redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT) with observed data only.||units on a scale||Standard Deviation|Mean
686662|NCT01487577|Secondary|Number of Participants Who Experienced Relapse.||1 year|||participants|||Number
681730|NCT01551758|Primary|Mean Annual Rate of Moderate or Severe COPD Exacerbations|Mean annual rate of moderate or severe COPD exacerbations during treatment were assessed. Moderate exacerbation: participant received exacerbation-related prescription of oral corticosteroids and/ or antibiotic (with/without National Health Service [NHS] contact) not requiring hospitalisation. Severe exacerbation: an exacerbation-related hospitalisation. Analysis method was Generalised Linear Model (GLM) assuming the negative binomial distribution with a log-link function and logarithm of time on treatment as an offset variable, adjusted for randomized treatment, baseline COPD maintenance therapy per randomisation stratification, number of moderate/severe COPD exacerbations in previous year and smoking status at baseline. Intent to treat (ITT) population: all randomised participants who received a prescription of study medication. Primary Efficacy Analysis Population: all ITT participants who had at least one moderate/severe exacerbation in the year prior to randomization|Up to 54 weeks|Primary Efficacy Analysis Population.||Exacerbations per participant per year||95% Confidence Interval|Least Squares Mean
681731|NCT01551693|Secondary|Overall Survival|Overall survival is defined as the time from study entry to death or date last known alive and estimated using Kaplan-Meier (KM) methods.|Patients were followed every 4 weeks for survival until death, lost to follow-up or study closure (approximately 6 months after the last patient ended treatment). In this study cohort, patients were followed up to 13 weeks.|Overall survival was not estimated given the limited sample size.|||||
681732|NCT01551693|Secondary|Best Overall Response|Best overall response (BOR) on treatment was based on RECIST 1.0 criteria. For target lesions, complete response (CR) is complete disappearance of all target lesions and partial response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. CR or PR confirmation required within 4 weeks. Progressive disease (PD) is at least a 20% increase in the sum LD of target lesions from smallest sum LD as reference or the appearance of one or more new lesions. Stable disease (SD) is neither meeting PR or PD. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions. CR is disappearance of all non-target lesions.|Disease was evaluated radiologically at baseline and every 8 weeks on treatment. Median (range) treatment duration was 1 cycle/4 weeks (1-2 cycles; 4-8 weeks).|||participants|||Number
681733|NCT01551693|Primary|6-month Progression-Free Survival Rate|6-month progression-free survival rate was defined as the proportion of patients absent death or progression based on Response Evaluation Criteria In Solid Tumors Criteria (RECIST) before 6 months. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.|Disease was evaluated radiologically at baseline and every 8 weeks on treatment; Treatment continued until evidence of disease progression or unacceptable toxicity. Relevant for this endpoint was disease status at 6 months.|||proportion of participants|||Number
681734|NCT01551355|Secondary|Body Mass Index - BMI|The body mass index (BMI), or Quetelet index, is a measure of relative weight based on an individual's mass and height = Kg/m²|baseline|||Kg/m²||Standard Deviation|Mean
681735|NCT01551355|Secondary|KAH Score for Teachers|"Change in Weighted knowledge, attitude, habit (KAH) score (70/20/10) among teachers after 5 months of intervention as compared to prior to intervention.
Because we hypothesized that the mean change in knowledge scores associated with this short intervention period would be larger than the mean changes in scores due to attitudes and habits, we a priori gave differential weights (70, 20, and 10, respectively) to the scores to compose a standardized weighted total score (WTS).
We developed questionnaires to measure knowledge, attitudes, and habits on healthy eating and living an active lifestyle in children, parents, and teachers.
Scale range: 0-100 Knowledge scale range: 0-100 Attitude scale range: 0-100 Habit scale range: 0-100 WTS (weighted total score) scale range: 0-100 Higher values represent a better outcome"|at baseline and at 6 months|Change in weighted total score controlling for Cluster Effect, Sex, Age, Children’s Weight, and Teacher’s Educational Level after 5-Month Intervention. Data available only for 37 teachers in healthy habits arm and 35 teachers in usual curriculum arm.||units on a scale||95% Confidence Interval|Mean
681736|NCT01551355|Secondary|KAH Score for Parents|"Change in Weighted knowledge, attitude, habit (KAH) score (70/20/10) among parents after 5 months of intervention as compared to prior to intervention.
Because we hypothesized that the mean change in knowledge scores associated with this short intervention period would be larger than the mean changes in scores due to attitudes and habits, we a priori gave differential weights (70, 20, and 10, respectively) to the scores to compose a standardized weighted total score (WTS).
Questionnaires were developedheae to measure knowledge, attitudes, and habits on healthy eating and living an active lifestyle in children, parents, and teachers.
Scale range: 0-100 Knowledge scale range: 0-100 Attitude scale range: 0-100 Habit scale range: 0-100 WTS (weighted total score) scale range: 0-100 Higher values represent a better outcome"|at baseline and at 6 months|Change in weighted total score controlling for Cluster Effect, Sex, Age, Children’s Weight, and Teacher’s Educational Level after 5-Month Intervention. Data available only for 402 parents in healthy habits arm and 360 parents in usual curriculum arm.||units on a scale||95% Confidence Interval|Mean
681737|NCT01551355|Primary|Change in KAH Score for Children|"Change in weighted knowledge, attitude, habit (KAH) (70/20/10) score among children after 5 months of intervention as compared to prior to intervention.
The study hypothesized that the mean change in knowledge scores associated with this short intervention period would be larger than the mean changes in scores due to attitudes and habits, differential weights (70, 20, and 10, respectively) were given to the scores a priori to compose a standardized weighted total score (WTS).
The developed questionnaires measured knowledge, attitudes, and habits on healthy eating and living an active lifestyle in children, parents, and teachers.
Scale range: 0-100 Knowledge scale range: 0-100 Attitude scale range: 0-100 Habit scale range: 0-100 WTS (weighted total score) scale range: 0-100
Higher values represent a better outcome"|at baseline and at 6 months|"The analysis was done with children that answered al questions in 3 topics: knowledge, attitudes and habits.
Change Score in Weighted total score controlling for Cluster Effect, Sex, Age, Children’s Weight, and Teacher’s Educational Level after 5-Month Intervention."||units on a scale||95% Confidence Interval|Mean
681792|NCT01550952|Primary|Hand Grip Strength|Hand grip strength as measured by a dynamometer. Percentage change in measure as compared to post-surgery (with post-surgery measure at 0%).|2 days postoperatively|One participant declined assessment due to soreness in the shoulder muscle.||percent||Inter-Quartile Range|Median
681738|NCT01551303|Primary|Affective Ratings in Affective Learning Task|"We will measure the effect of the drug on affective learning, using the Affective Learning Task. Participants viewed 30 neutral faces, each paired with one sentence describing a negative positive, or neutral behavior, counterbalanced across participants. During the test phase, participants will rate the faces as negative, neutral, or positive. These ratings were averaged. Responses were coded as: negative = -1, neutral = 0, positive =1, so the averaged scores have a possible range between -1 and 1. Since this is not a treatment study for a disease, there is so better or worse outcome."|30 minutes after drug administration|||units on a scale||Standard Error|Mean
681739|NCT01551199|Primary|Clinician Administered PTSD Scale (CAPS)|The CAPS is a clinician-administered interview assessing 17 symptoms of PTSD (based on DSM-IV criteria). Frequency of symptoms are rated on a scale from 0 (never/none) to 4 (daily/almost every day). Intensity of symptoms are rated using a scale of 0 (none) to 4 (extreme). Total severity score is derived by summing the frequency and intensity scores. A recommended cut-off of 45 is used to determine the presence of full PTSD. Higher scores suggest greater symptom severity.|3-month follow-up (approximately week 26)|||units on a scale||Standard Deviation|Mean
681740|NCT01551199|Secondary|Anxiety Disorders Interview Schedule- DSM-IV (ADIS-IV)|The ADIS-IV is a semi-structured diagnostic interview for anxiety disorders (based on DSM-IV criteria). DSM-IV criteria for panic disorder include recurrent unexpected panic attacks and (1) persistant concern or worry about additional panic attacks or their consequences or (2) significant change in behavior related to panic attacks.|3 Months|||percentage of participants|||Number
681741|NCT01551199|Primary|Clinician Administered PTSD Scale (CAPS)|The CAPS is a clinician-administered interview assessing 17 symptoms of PTSD (based on DSM-IV criteria). Frequency of symptoms are rated on a scale from 0 (never/none) to 4 (daily/almost every day). Intensity of symptoms are rated using a scale of 0 (none) to 4 (extreme). Total severity score is derived by summing the frequency and intensity scores. A recommended cut-off of 45 is used to determine the presence of full PTSD. Higher scores suggest greater symptom severity.|1-week post-treatment (approximately week 14)|||units on a scale||Standard Deviation|Mean
681742|NCT01551173|Secondary|Proportion of Patients Achieving Their LDL-C Treatment Goals at Week 4, Week 8, Week 12, and Endpoint|LDL-C treatment goal is defined as patients at moderate CV risk with LDL-C levels < 3.37 mmol/L (130 mg/dL) or patients at high CV-risk with LDL-C levels < 2.59 mmol/L (100 mg/dL). The proportion of patients in each treatment group achieving their LDL-C goal during the double-blind period will be compared at Week 4, Week 8, Week 12 and Endpoint using a logistic regression model with treatment and center as factors and baseline LDL-C as a covariate. Odds ratio estimates derived from the logistic regression model and 95%CI will be used to quantify the treatment effect.|Baseline, week 4, week 8, week 12, Endpoint|FAS: all randomized patients who received at least one dose of double-blind study medication and one post-randomization efficacy parameter measurement. The intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization. Endpoint: final available post-baseline assessment to last scheduled visit||Percent of participants|||Number
681743|NCT01551173|Secondary|Change From Baseline at Week 4, Week 8, Week 12, and Endpoint for Lipid Variables Low Density Lipoprotein Cholesterol (LDL-C) , Total Cholesterol (TC), High Density Lipoprotein Cholesterol (HDL-C) , Non HDL-C, Triglycerides (TG)|After the patient has been sitting for at least 5 minutes, a 12 hour fasting blood sample will be withdrawn. An analogous ANCOVA model to that used in the analysis of the primary variable will be used to compare the change in LDL-C, TC, HDL-C, non HDL-C and TG from baseline between treatment groups at Week 4, Week 8, and Week 12|Baseline, week 4, week 8, week 12, Endpoint|FAS: all randomized patients who received at least one dose of double-blind study medication and one post-randomization efficacy parameter measurement. The intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization. Endpoint: final available post-baseline assessment to last scheduled visit||mmol/L||Standard Error|Mean
681744|NCT01551173|Primary|Mean Percent Change in LDL-C From Baseline at Study Endpoint, Week 12 (LOCF)|After the patient has been sitting for at least 5 minutes, a 12 hour fasting blood sample will be withdrawn at baseline and endpoint. An analysis of covariance (ANCOVA) with treatment, center, and indication category as factors and baseline LDL-C as a covariate will be used to analyze percent change from baseline in LDL-C.|Baseline, week 12|FAS: all randomized patients who received at least one dose of double-blind study medication and one post-randomization efficacy parameter measurement. The intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization. Endpoint: final available post-baseline assessment to last scheduled visit||Percent change||Standard Error|Mean
681745|NCT01551095|Secondary|Number of Participants With Retrograde Migration of PEGJ Feeding Tube Within 3 Weeks of Placement|An Abdominal X-ray was obtained 3 weeks after the procedure to check whether or not there was any PEGJ feeding tube migration.|From date of PEGJ placement up to 3 weeks|||participants|||Number
681746|NCT01551095|Primary|Safety: Number of Participants With Adverse Events|One week after the procedure patients were called by one of the study investigators and were asked whether or not they had Abdominal pain, Nausea or Vomiting after the procedure.|From date of PEGJ placement up to 3 weeks|||participants|||Number
681747|NCT01551082|Primary|Outpatient Chest Tube Management Following Thoracic Resection Improves Patient Length of Stay and Satisfaction Without Compromising Outcomes|Outcome measures for this study were to correlate outpatient chest tube management with patient satisfaction. Also to correlate decreased length of stay without compromising any patient outcomes.|2 years|Study was terminated and no data were collected for the outcome|||||
681748|NCT01551056|Secondary|Tolerability of Study Medication at Visit 3A|Tolerability was assessed upon instillation of study medication, at 1 minute and 2 minutes post study medication instillation. Drop comfort was assessed using a 0-to 10 scale where 0=very comfortable and 10=very uncomfortable.|upon instillation, 1 minute and 2 minutes post instillation|Intent to Treat (ITT)||units on a scale||Standard Deviation|Mean
681749|NCT01551056|Secondary|Composite Nasal Symptom Score at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. For Nasal Composite Score the Total Composite Score ranges from 0 to 16, higher scores represent greater severity. Patients needed to have at least one of the nasal symptoms present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) each symptom was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Composite score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT) with observed data only.||%participants with at least 1 nasal symp|||Number
681750|NCT01551056|Secondary|Composite Nasal Symptom Score at Duration of Action (16 Hours + 1 Hour Post-dose)|A treatment efficacy CAC was performed 16 hours + 1 hour after drop instillation. For Nasal Composite Score the Total Composite Score ranges from 0 to 16, higher scores represent greater severity. Patients needed to have at least one of the nasal symptoms present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) each symptom was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Composite score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT) with observed data only.||%participants with at least 1 nasal symp|||Number
681751|NCT01551056|Secondary|Nasal Congestion at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Nasal Congestion was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Congestion score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT) with observed data only.||units on a scale||Standard Deviation|Mean
681752|NCT01551056|Secondary|Nasal Congestion at Duration of Action (16 Hours + 1 Hour Post-dose)|A treatment efficacy CAC was performed 16 hours + 1 hour after drop instillation. Nasal Congestion was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Congestion score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT) with observed data only.||units on a scale||Standard Deviation|Mean
681753|NCT01551056|Secondary|Ear or Palate Pruritis at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Ear or Palate Pruritus was assessed by the patient on a single 0-4 scale (0=none to 4=severe). Ear or Palate Pruritus score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT) with observed data only.||units on a scale||Standard Deviation|Mean
681754|NCT01551056|Secondary|Ear or Palate Pruritis at Duration of Action (16 Hours + 1 Hour Post-dose)|A treatment efficacy CAC was performed 16 hours + 1 hour after drop instillation. Ear or Palate Pruritus was assessed by the patient on a single 0-4 scale (0=none to 4=severe). Ear or Palate Pruritus score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT) with observed data only.||units on a scale||Standard Deviation|Mean
681755|NCT01551056|Secondary|Nasal Pruritis at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Nasal Pruritus was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Pruritus score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT) with observed data only.||units on a scale||Standard Deviation|Mean
681756|NCT01551056|Secondary|Nasal Pruritis at Duration of Action (16 Hours + 1 Hour Post-dose)|A treatment efficacy CAC was performed 16 hours + 1 hour after drop instillation. Nasal Pruritus was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Pruritus score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT) with observed data only.||units on a scale||Standard Deviation|Mean
681757|NCT01551056|Secondary|Rhinorrhea at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Rhinorrhea was assessed by the patient on a 0-4 scale (0=none to 4=severe). Rhinorrhea score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT) with observed data only.||units on a scale||Standard Deviation|Mean
681758|NCT01551056|Secondary|Rhinorrhea at Duration of Action (16 Hours +1 Hour Post-dose)|A treatment efficacy CAC was performed 16 hours + 1 hour after drop instillation. Rhinorrhea was assessed by the patient on a 0-4 scale (0=none to 4=severe). Rhinorrhea score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT) with observed data only.||units on a scale||Standard Deviation|Mean
681759|NCT01551056|Secondary|Tearing at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Tearing was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of tearing score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT) with observed data only.||units on a scale||Standard Deviation|Mean
681760|NCT01551056|Secondary|Tearing at Duration of Action (16 Hours + 1 Hour Post-dose)|A treatment efficacy CAC was performed 16 hours + 1 hour after drop instillation. Tearing was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of tearing score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT) with observed data only.||units on a scale||Standard Deviation|Mean
681761|NCT01551056|Secondary|Eyelid Swelling at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Eyelid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of eyelid swelling score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT) with observed data only.||units on a scale||Standard Deviation|Mean
681762|NCT01551056|Secondary|Eyelid Swelling at Duration of Action (16 Hours + 1 Hour Post-dose)|A treatment efficacy CAC was performed 16 hours + 1 hour after drop instillation. Eyelid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of eyelid swelling score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT) with observed data only.||units on a scale||Standard Deviation|Mean
681763|NCT01551056|Secondary|Chemosis at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Chemosis was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of chemosis score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT) with observed data only.||units on a scale||Standard Deviation|Mean
681764|NCT01551056|Secondary|Chemosis at Duration of Action (16 Hours + 1 Hour Post-dose)|A treatment efficacy CAC was performed 16 hours + 1 hour after drop instillation. Chemosis was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of chemosis score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT) with observed data only.||units on a scale||Standard Deviation|Mean
681765|NCT01551056|Secondary|Episcleral Redness at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Episcleral Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of episcleral redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT) with observed data only.||units on a scale||Standard Deviation|Mean
681766|NCT01551056|Secondary|Episcleral Redness at Duration of Action (16 Hours + 1 Hour Post-dose)|A treatment efficacy CAC was performed 16 hours + 1 hour after drop instillation. Episcleral Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of episcleral redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT) with observed data only.||units on a scale||Standard Deviation|Mean
681769|NCT01551056|Primary|Conjunctival Redness at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)||units on a scale||Standard Deviation|Mean
681770|NCT01551056|Primary|Conjunctival Redness at Duration of Action (16 Hours + 1 Hour Post-dose)|A treatment efficacy CAC was performed 16 hours + 1 hour after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)||units on a scale||Standard Deviation|Mean
681771|NCT01551056|Primary|Ocular Itching at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.|3, 5, 7 minutes post-CAC|Intent to Treat (ITT)||units on a scale||Standard Deviation|Mean
681772|NCT01551056|Primary|Ocular Itching at Duration of Action (16 Hours + 1 Hour Post-dose)|A treatment efficacy Conjunctival Allergen Challenge (CAC) was performed 16 hours + 1 hour after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.|3, 5, 7 minutes post-CAC|Intent to Treat (ITT)||units on a scale||Standard Deviation|Mean
681773|NCT01550965|Secondary|Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Percentage of Activity Impairment|WPAI-SHP is a questionnaire used to assess the effect of the participant's health problems on their ability to work and perform regular activities. The scores on the WPAI questionnaire are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Change in WPAI-SHP was calculated by deducting the final score from the baseline score. A higher score indicates an increased impairment. A positive value of change indicates an increased impairment of work productivity and the limitation of activities of daily life, while a negative value indicates an improvement. N = participants with evaluable baseline and post-baseline data.|Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26|All participants in the ITT population with evaluable data.||percentage of activity impairment||Standard Deviation|Mean
681774|NCT01550965|Secondary|Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Overall Work Impairment Percentage|WPAI-SHP is a questionnaire used to assess the effect of the participant’s health problems on their ability to work and perform regular activities. The scores on the WPAI questionnaire are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Change in WPAI-SHP was calculated by deducting the final score from the baseline score. A higher score indicates an increased impairment. A positive value of change indicates an increased impairment of work productivity and the limitation of activities of daily life, while a negative value indicates an improvement. The overall work impairment data was applicable to employed participants only. N = participants with evaluable baseline and post-baseline data.|Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26|All participants in the ITT population with evaluable data.||percentage of overall work impairment||Standard Deviation|Mean
681775|NCT01550965|Secondary|Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Percentage of Impairment While Working|WPAI-SHP is a questionnaire used to assess the effect of the participant's health problems on their ability to work and perform regular activities. The scores on the WPAI questionnaire are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Change in WPAI-SHP was calculated by deducting the final score from the baseline score. A higher score indicates an increased impairment. A positive value of change indicates an increased impairment of work productivity and the limitation of activities of daily life, while a negative value indicates an improvement. The percentage of impairment while working data was applicable to employed participants only. N = participants with evaluable baseline and post-baseline data.|Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26|All participants in the ITT population with evaluable data.||percentage of impairment while working||Standard Deviation|Mean
681776|NCT01550965|Secondary|Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Percentage of Work Time Missed|WPAI-SHP is a questionnaire used to assess the effect of the participant's health problems on their ability to work and perform regular activities. A higher score indicates an increased impairment. A positive value of change indicates an increased impairment of work productivity and the limitation of activities of daily life, while a negative value indicates an improvement. The percentage of work time missed data was applicable to employed participants only. N = participants with evaluable baseline and post-baseline data.|Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26|All participants in the ITT population with evaluable data.||percentage of work time missed||Standard Deviation|Mean
681777|NCT01550965|Secondary|Mean Change From Baseline in European Quality of Life – 5 Dimensions – 5 Level (EQ-5D-5L) Total Score|EQ-5D-5L Total Score provides a descriptive profile of health status. It comprises of 5 dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) to describe the subject's current health state. Each dimension comprises 5 levels with corresponding numeric scores ranging from 1 (no problems) through 5 (extreme problems). A unique EQ-5D-5L health state was defined by combining the numeric level scores for each of the 5 dimensions and the total score ranges from -0.594 to 1, with higher scores representing a better health state. An increase in the EQ-5D-5L total score indicates improvement. N = participants with evaluable baseline and post-baseline data.|Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26|All participants in the ITT population with evaluable data.||units on a scale||Standard Deviation|Mean
681778|NCT01550965|Secondary|Mean Change From Baseline in Total Simple Clinical Colitis Activity Index (SCCAI)|The SCCAI measures disease activity as assessed by the investigator and includes the following 6 items: bowel frequency (day), bowel frequency (night), urgency of defecation, blood in stool, general well-being and extra colonic features. The score ranges from 0 (best) to 19 points (worst).|Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26|All participants in the ITT population with evaluable data.||units on a scale||Standard Deviation|Mean
681779|NCT01550965|Secondary|Mean Change From Baseline in Physician's Global Assessment (PGA)|The Physician’s Global Assessment was used to measure the participant’s disease activity. The physician considered the participant’s reported information such as number of stools, rectal bleeding, abdominal discomfort, and functional assessment during the previous day prior to the visit, and other observations such as physical findings, and the participant’s performance status at the time of the visit. Based on the above information the investigator made an overall assessment of participant’s current severity of UC using the ordinal scale from 0 (normal) to 3 (severe disease).|Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26|All participants in the ITT population with evaluable data.||units on a scale||Standard Deviation|Mean
681780|NCT01550965|Secondary|Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ): Total Score Over Time|The SIBDQ is a disease-specific health-related quality of life (HRQoL) questionnaire, used to detect changes in inflammatory bowel disease (IBD) participants by measuring physical, social and emotional status. The SIBDQ consists of 10 questions, each question is scored on a scale from 1 (poor QoL) to 7 (good QoL). A higher score indicates a better health-related quality of life. Total scores range from 10 (poor QoL) to 70 (good QoL). N = participants with evaluable baseline and post-baseline data.|Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26|All participants in the ITT population with evaluable data.||units on a scale||Standard Deviation|Mean
681781|NCT01550965|Secondary|Percentage of Participants With Absence of Blood in Stool|Participants with absence of blood in stool were reported.|Week 26|All participants in the ITT population with evaluable data.||percentage of participants|||Number
681782|NCT01550965|Secondary|Mean Change From the 6 Months Prior to Treatment With Adalimumab to the 6 Months After Beginning Treatment With Adalimumab in UC-related Outpatient Utilization, Including Emergency Department Visits, Unscheduled Consultation, Exam Procedures|UC-related outpatient utilization was determined from the health care utilization information. Outpatient utilization was the number of procedures/surgeries performed during outpatient visits. Participants without any outpatient utilization were excluded.|6 months prior to treatment start (Week 0 [baseline]) and 6 months after treatment start (total 12 months)|All participants in the ITT population with evaluable data.||Procedures/ Surgeries||Standard Deviation|Mean
681783|NCT01550965|Secondary|Mean Change From Baseline in Participant's Satisfaction Using Treatment Satisfaction Questionnaire for Medication (TSQM)|TSQM is a questionnaire to be completed by the participants to determine their satisfaction of the medications for ulcerative colitis including the study drug. The TSQM is a 14-item subject-rated scale that evaluates the effectiveness, side effects, convenience, and global satisfaction of the medication over the past 2-3 weeks. Each of the 14 questions are scored from 1 (worst) to 7 points (best); and each of the domains are scored from 0 (less satisfaction) to 100 (better satisfaction). N = participants with evaluable baseline and post-baseline data.|Week 0 (baseline) and Week 26|All participants in the ITT population with evaluable data.||units on a scale||Standard Deviation|Mean
681784|NCT01550965|Secondary|Mean Change From the 6 Months Prior to Treatment With Adalimumab to the 6 Months After Beginning Treatment With Adalimumab in UC-related and All-cause Hospitalization|Hospitalization was defined as number of bed days in hospital as determined from the health care utilization information.|6 months prior to treatment start (Week 0 [baseline]) and 6 months after treatment start (total 12 months)|All participants in the ITT population with evaluable data.||Days||Standard Deviation|Mean
681785|NCT01550965|Secondary|Mean Change From the 6 Months Prior to Treatment With Adalimumab to the 6 Months After Beginning Treatment With Adalimumab in UC-related Direct and Indirect Health Care Costs|UC-related direct and indirect health care costs included, but were not limited to: surgical procedures, hospitalizations, bed days in hospital, unscheduled physician consultations, emergency room visits, unscheduled examination appointments, radiology appointments, endoscopy appointments, medications and indirect costs based on WPAI.|6 months prior to treatment start (Week 0 [baseline]) and 6 months after treatment start (total 12 months)|All participants in the ITT population with evaluable data.||Pound Sterling (GBP)||Standard Deviation|Mean
681786|NCT01550965|Secondary|Mean Change From the 6 Months Prior to Treatment With Adalimumab to the 6 Months After Beginning Treatment With Adalimumab in Total All-cause Direct Health Care Costs (Excluding Adalimumab Costs)|Medical care costs included, but were not limited to: surgical procedures, hospitalizations, bed days in hospital, unscheduled physician consultations, emergency room visits, unscheduled examination appointments, radiology appointments, endoscopy appointments and medications.|6 months prior to treatment start (Week 0 [baseline]) and 6 months after treatment start (total 12 months)|All participants in the ITT population with evaluable data.||Pound Sterling (GBP)||Standard Deviation|Mean
681787|NCT01550965|Primary|Mean Change From the 6 Months Prior to Treatment With Adalimumab to the 6 Months After Beginning Treatment With Adalimumab in Costs of UC-related Medical Care Excluding Adalimumab Costs|Medical care costs included, but were not limited to: surgical procedures, hospitalizations, bed days in hospital, unscheduled physician consultations, emergency room visits, unscheduled examination appointments, radiology appointments, endoscopy appointments and medications.|6 months prior to treatment start (Week 0 [baseline]) and 6 months after treatment start (total 12 months)|All participants in the ITT population with evaluable data.||Pound Sterling (GBP)||Standard Deviation|Mean
681788|NCT01550965|Primary|Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ): Total Score|The SIBDQ is a disease-specific health-related quality of life (HRQOL) questionnaire, able to detect and define meaningful clinical changes in inflammatory bowel disease (IBD) participants by measuring physical, social and emotional status. The SIBDQ consists of 10 questions; each question is scored on a scale from 1 (poor QOL) to 7 (optimum QOL). A higher score indicates a better health-related quality of life. Total scores range from 10 (poor QoL) to 70 (good QoL).|Week 0 (baseline) and Week 26|All participants in the ITT population with evaluable data.||units on a scale||Standard Deviation|Mean
681789|NCT01550952|Secondary|Total Oral Opioid Intake in 48hrs|Opioid Usage|0-48hrs|||mg||Standard Deviation|Mean
681790|NCT01550952|Secondary|Numeric Rating Scale (NRS) Pain Scores With Movement|NRS pain scores (0-10; 0 = no pain, 10 = worst pain possible) assessed.|2 days postoperatively|||units on a scale||Inter-Quartile Range|Median
681791|NCT01550952|Secondary|Number of Participants With Reduced Sensation in a Dermatome|Pin-prick sensation assessed.|2 days postoperatively|Dermatomes could not be assessed for one patient due to sedation||participants|||Number
686663|NCT01487577|Secondary|Number of Participants With Neutrophil and Platelet Engraftment.|Neutrophil and platelet engraftment definitions as defined by the CIBMTR Data Management Manual.|100 days|||participants|||Number
681794|NCT01550809|Secondary|The Area Under the Curve (AUC) of Plasma Glucose (PG) Above the Threshold of 140 mg/dl (AUC-PG>140).|"The AUC-PG>140 during the 5-hour period following the meal test represents the hyperglycemic risk related to the modality of prandial insulin administration.
Plasma glucose (PG) for calculation of AUC-PG>140 was measured every 15 minutes following the insulin administration and during the whole 5-hour postprandial period (300 minutes)."|The whole experiment, i.e. the 5-hour postprandial period|||mg*h/dl||Standard Deviation|Mean
681795|NCT01550809|Primary|The Area Under the Curve (AUC) of the Glucose Infusion Rate (GIR) During the 5-hour Postprandial Period (AUC-GIR0-5h).|"The amount of glucose infused during the 5-hour postprandial period (AUC-GIR0-5h) is a measure of the hypoglycemic exposure associated with the modality of prandial insulin administration. Indeed, glucose will be infused only when patients are under a predefined blood glucose values (80 mg/dl) with a descending trend.
Glucose infusion rate (GIR) for calculation of AUC-GIR was measured every minute following the insulin administration and during the whole 5-hour postprandial period (300 minutes)."|The whole experiment, i.e. 5 hours.|||mg/kg||Standard Deviation|Mean
681796|NCT01550809|Primary|The Area Under the Curve (AUC) of Plasma Glucose (PG) Concentrations During the 5-hour Postprandial Period (AUC-PG0-5 h).|"AUC-PG0-5 h (5-hour postprandial glucose following the mixed meal test) is a measure of the overall glucose-lowering efficacy of the insulin bolus. The lower the AUC-PG0-5 h without hypoglycemia, the greater the effectiveness of the prandial insulin administration to control the meal related glucose excursion.
Plasma glucose (PG) for calculation of AUC-PG was measured every 15 minutes following the insulin administration and during the whole 5-hour postprandial period (300 minutes)."|The whole experiment, i.e. 5 hours|This was a proof-of-concept study. However, as an estimation of N, a two-sided t-test achieved 84% power to infer that the mean difference was not 0 when the total sample size of a 2x2 crossover design was 12, the actual mean difference in the AUC-PG0-5 h was 100mg*dl-1*h, the square root of the within mean square error was 75.0 and alpha was 0.05.||mg*h/dl||Standard Deviation|Mean
681797|NCT01550744|Secondary|The Percentage of Participants With a PASI 75 Response Over Time|The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 to 72. A PASI 75 response is defined as greater than or equal to (>=) 75 percent (%) improvement in PASI score from baseline.|Week 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112|The Analysis population was “subjects randomized at Week 28 data set”. 'n' signifies number of participants who were evaluable at each specific timepoint, for each arm, respectively.||percentage of participants|||Number
681798|NCT01550744|Secondary|The Number of Visits for Which Participants Achieved a Psoriasis Area and Severity Index (PASI) 75 Response|The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 to 72. A PASI 75 response is defined as greater than or equal to (>=) 75 percent (%) improvement in PASI score from baseline.|Up to 24 weeks (Week 88 up to Week 112 [total 7 visits])|The “subjects randomized at Week 28 data set” was defined as the population of enrolled participants who were randomized to either Group 1 or Group 2 at Week 28.||number of visits||Standard Deviation|Mean
681799|NCT01550744|Secondary|The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time|Clinical responses for week (wk) 28 sPGA responders randomized to every 12 weeks (q12wk) fixed-interval dosing (Group 1) vs. patient-tailored fixed-interval dosing (Group 2) were assessed using the static PGA (sPGA) measure. Investigators graded psoriasis lesions for induration (0=no plaque elevation to 5=severe plaque elevation), erythema (0=no evidence of erythema to 5=dusky to deep red coloration), and scaling (0=no evidence of scaling to 5=severe scaling). The sum of the 3 scales is divided by 3 and rounded to obtain a final sPGA score, defined as 0=cleared (except for residual discoloration), 1=minimal, 2=mild, 3=moderate, 4=marked or 5=severe.|Week 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112|The Analysis population was “subjects randomized at Week 28 data set”. 'n' signifies number of participants who were evaluable at each specific timepoint, for each arm, respectively.||percentage of participants|||Number
681800|NCT01550744|Primary|The Number of Visits at Which Participants Achieved a Static Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1)|Clinical responses for week (wk)28 sPGA responders randomized to every 12 weeks (q12wk) fixed-interval dosing (Group 1) vs. patient-tailored fixed-interval dosing (Group 2) were assessed using the static PGA (sPGA) measure. Investigators graded psoriasis lesions for induration (0=no plaque elevation to 5=severe plaque elevation), erythema (0=no evidence of erythema to 5=dusky to deep red coloration), and scaling (0=no evidence of scaling to 5=severe scaling). The sum of the 3 scales is divided by 3 and rounded to obtain a final sPGA score, defined as 0=cleared (except for residual discoloration), 1=minimal, 2=mild, 3=moderate, 4=marked or 5=severe.|Up to 24 weeks (Week 88 up to Week 112 [total 7 visits])|The “subjects randomized at Week 28 data set” was defined as the population of enrolled participants who were randomized to either Group 1 or Group 2 at Week 28.||number of visits||95% Confidence Interval|Mean
681801|NCT01550705|Secondary|Participants With Increased Sun Sensitivity|Study participants were asked to report after 3 months if they had experienced an increase in subjective measures of sun sensitivity during the trial. Reported outcome is the number of study participants who reported increased sun sensitivity|Baseline and 3 Months|||participants|||Number
681802|NCT01550705|Primary|Change in Plasma Protoporphyrin IX Level|Plasma Protoporphyrin IX will be measured at baseline and at 3 months|Baseline and 3 Months|||µg/dL||Standard Deviation|Mean
681803|NCT01550549|Post-Hoc|Individual Reader Results (Autopsy Within 1 Year of Scan)|Reader results (number of false negatives and number of false positives) for blinded independent readers. There were a total of 28 positive and 18 negative scans based on histopathology at autopsy.|Baseline scan|||florbetapir scans|||Number
681804|NCT01550549|Post-Hoc|Individual Reader Results (All Scans With Autopsy)|Reader results (number of false negatives and number of false positives) for blinded independent readers. There were a total of 39 positive and 20 negative scans based on histopathology at autopsy.|Baseline scan|||florbetapir scans|||Number
681805|NCT01550549|Other Pre-specified|Median Sensitivity and Specificity vs. CERAD Diagnosis|Median sensitivity and specificity for 5 independent readers to detect moderate to frequent amyloid plaques (per CERAD criteria).|Baseline scan|||percentage of true positives/negatives||Full Range|Median
681806|NCT01550549|Post-Hoc|Inter-reader Reliability|Measure of agreement among multiple readers using binary read method (Fleiss' kappa). Where available, histopathology analysis at autopsy was the truth standard (TS).|Scan acquired 50-60 min post-injection|59 from study A07(NCT00857415)/A16(NCT01447719) and 92 from study A05(NCT00702143)||kappa statistic||95% Confidence Interval|Number
681807|NCT01550549|Secondary|Specificity of Florbetapir-PET to Detect no or Sparse Beta-amyloid Neuritic Plaques (Probable/Definite Alzheimer's Disease)|Calculated as the percent of true negatives which are correctly identified|at autopsy, within 2 years of scan|||percentage of negative cases IDed||95% Confidence Interval|Number
681808|NCT01550549|Secondary|Sensitivity of Florbetapir-PET to Detect Moderate to Frequent Beta-amyloid Neuritic Plaques (Probable/Definite Alzheimer's Disease)|Calculated as the percent of true positives which are correctly identified|at autopsy, within 2 years of scan|||percentage of positive cases IDed||95% Confidence Interval|Number
681809|NCT01550549|Primary|Inter-rater Reliability|Measure of agreement among five readers using a binary read method (amyloid positive/negative) calculated using Fleiss' kappa. All scans were read in a blinded fashion without access to clinical information.|Scan acquired 50-60 min post-injection|59 autopsy subjects (study A07[NCT00857415]/A16[NCT01447719]) + 20 healthy controls + 20 mild cognitive impairment + 20 AD (from study A05[NCT00702143])||kappa statistic||95% Confidence Interval|Number
681810|NCT01550302|Secondary|Number of Patients With Post-operative Side Effects Such as Post-operative Nausea and Vomiting (PONV), Pruritus, Sedation, Respiratory Depression and Hypotension||24 and 48 hours after the surgery|Hypotension data not collected||Participants|||Count of Participants
681811|NCT01550302|Secondary|Number of Participants Requiring Post-operative Ibuprofen as a Rescue Medication||48 hours after the surgery|||number of participants|||Number
681812|NCT01550302|Secondary|Numeric Response Scale Pain Scores Around Chest Tube Insertion Site at Rest and During Coughing|Data collected on an interval scale ranging from 0 (no pain) to 10 (highest or most pain). Reported data shows an average of scores across participants|6, 12, 18, 24 and 48 hours after the surgery|Data not collected for 6, 12, and 18 hours at rest or with movement/cough||units on a scale||Standard Deviation|Mean
681813|NCT01550302|Secondary|Numeric Response Scale Pain Scores at Incision Site at Rest and During Coughing|Data collected on an interval scale ranging from 0 (no pain) to 10 (highest or most pain). Reported data shows an average of scores across participants|6, 12, 18, 24 and 48 hours after the surgery|Data not collected for 6, 12, and 18 hours at rest or moving/with cough||units on a scale||Standard Deviation|Mean
681814|NCT01550302|Secondary|Numeric Response Scale Pain Scores Around Ipsilateral Shoulder at Rest and During Movement|Data collected on an interval scale ranging from 0 (no pain) to 10 (highest or most pain). Reported data shows an average of scores across participants|6, 12, 18, 24 and 48 hours after the surgery|Data not collected for 6, 12, and 18 hours at rest or with movement/coughing||units on a scale||Standard Deviation|Mean
681815|NCT01550302|Secondary|Post-operative Opioid Consumption Expressed in Morphine Equivalents||24 hours after the surgery|||mg||Standard Deviation|Mean
681816|NCT01550302|Primary|Incidence of Post-thoracotomy/Scopy Ipsilateral Shoulder Pain||24 hours after lung surgery|||Participants|||Count of Participants
681817|NCT01550289|Secondary|Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo|Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) immune participants at baseline are defined as those participants with ≥10 (1/dil) for at least one serotype with the parental dengue virus strain or for Japanese encephalitis (JE) virus.|Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)|Geometric mean titers ratios were assessed in the Full Analysis Set with available data for each time point.||Titer ratio||95% Confidence Interval|Geometric Mean
681818|NCT01550289|Secondary|Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo|Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) non immune participants at baseline are defined as those participants with <10 (1/dil) for all serotypes with parental dengue virus strains and for Japanese encephalitis (JE) virus.|Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)|Geometric mean titers were assessed in the Full Analysis Set with available data for each time point.||Titers (1/dilutions)||95% Confidence Interval|Geometric Mean
681819|NCT01550289|Secondary|Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo|Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) immune participants at baseline are defined as those participants with ≥10 (1/dil) for at least one serotype with the parental dengue virus strain or for Japanese encephalitis (JE) virus.|Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)|Geometric mean titers ratios were assessed in the Full Analysis Set with available data for each time point.||Titer ratio||95% Confidence Interval|Geometric Mean
681820|NCT01550289|Secondary|Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo|Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) immune participants at baseline are defined as those participants with ≥10 (1/dil) for at least one serotype with the parental dengue virus strain or for Japanese encephalitis (JE) virus.|Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)|Geometric mean titers were assessed in the Full Analysis Set with available data for each time point.||Titers (1/dilutions)||95% Confidence Interval|Geometric Mean
681821|NCT01550289|Secondary|Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo|Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) non immune participants at baseline are defined as those participants with <10 (1/dil) for all serotypes with parental dengue virus strains and for Japanese encephalitis (JE) virus.|Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)|Dengue neutralizing antibody titers were assessed in the Full Analysis Set with available data for each time point.||Percentage of participants|||Number
681822|NCT01550289|Secondary|Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo|Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) immune participants at baseline are defined as those participants with ≥10 (1/dil) for at least one serotype with the parental dengue virus strain or for Japanese encephalitis (JE) virus.|Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)|Dengue neutralizing antibody titers were assessed in the Full Analysis Set with available data for each time point.||Percentage of participants|||Number
681823|NCT01550289|Secondary|Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo|Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) non-immune participants at baseline are defined as those participants with <10 (1/dil) for all serotypes with parental dengue virus strains and for Japanese encephalitis (JE) virus.|Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)|Dengue neutralizing antibody titers were assessed in the Full Analysis Set with available data for each time point.||Percentage of participants|||Number
681824|NCT01550289|Secondary|Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo|Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) immune participants at baseline are defined as those participants with ≥10 (1/dil) for at least one serotype with the parental dengue virus strain or for Japanese encephalitis (JE) virus.|Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)|Dengue neutralizing antibody titers were assessed in the Full Analysis Set with available data for each time point.||Percentage of participants|||Number
681825|NCT01550289|Primary|Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo|Solicited injection-site: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Asthenia. Grade 3 Solicited Injection site reactions: Pain Significant; prevents daily activities; Erythema and Swelling >100 mm. Grade 3 Solicited systemic reactions: Fever ≥39.0˚C; Headache, Malaise, Myalgia, and Asthenia Significant; prevents daily activities.|Day 0 up to Day 14 post each injection|Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set with available data for each time point.||Percentage of participants|||Number
681826|NCT01550289|Primary|Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo|Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT).|Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)|Geometric mean titer ratios were assessed in the Full Analysis Set with available data for each time point.||Titer ratio||95% Confidence Interval|Geometric Mean
681827|NCT01550289|Primary|Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo|Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT).|Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)|Geometric mean titers were assessed in the Full Analysis Set with available data for each time point.||Titers (1/dilutions)||95% Confidence Interval|Geometric Mean
681828|NCT01550289|Primary|Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Virus Serotypes Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo|Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT).|Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)|Dengue neutralizing antibody titers were assessed in the Full Analysis Set with available data for each time point.||Percentage of participants|||Number
681829|NCT01550289|Primary|Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Virus Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo|Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT).|Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)|Dengue neutralizing antibody titers were assessed in the Full Analysis Set with available data for each time point.||Percentage of participants|||Number
681830|NCT01549977|Secondary|Percentage of Participants Stopping ETT Due to Angina at Week 12|The percentage of participants who had to stop exercise treatment testing (ETT) due to experiencing angina symptoms at Week 12.|Week 12|This analysis was not performed since only one participant completed the study prior to study termination.|||||
681831|NCT01549977|Secondary|Change From Baseline in Maximum ST-segment Depression During ETT at Week 12|The change between the maximum ST-segment depression during ETT at Week 12 relative to Baseline. ST-segment is measured by electrocardiography (ECG) and represents the interval between ventricular depolarization and repolarization.|Baseline and Week 12|This analysis was not performed since only one participant completed the study prior to study termination.|||||
681832|NCT01549977|Secondary|Change From Baseline in Time to Onset of ≥1 mm ST-segment Depression During ETT at Week 12|The change between the time to onset of ≥1 mm ST-segment depression during exercise treadmill test (ETT) at Week 12 relative to Baseline. ST-segment is measured by electrocardiography (ECG) and represents the interval between ventricular depolarization and repolarization.|Baseline and Week 12|This analysis was not performed since only one participant completed the study prior to study termination.|||||
681833|NCT01549977|Secondary|Change From Baseline in Time to Onset of Angina During ETT at Week 12|The change between the time to onset of angina during the exercise treadmill test (ETT) at Week 12 relative to Baseline.|Baseline and Week 12|This analysis was not performed since only one participant completed the study prior to study termination.|||||
681834|NCT01549977|Primary|Change From Baseline in Exercise Treadmill Testing (ETT) Duration at Week 12|The change between the duration of ETT at Week 12 relative to Baseline. ETTs were conducted using the modified Bruce Protocol. Participants exercised on a treadmill, starting at 1.7 mph and 0% incline. The intensity of exercise (speed and/or incline) was increased at 3 minute intervals.|Baseline and Week 12|This analysis was not performed since only one participant completed the study prior to study termination.|||||
681835|NCT01549964|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|The change between FPG collected at week 24 relative to Baseline. A MMRM model was used for analysis with treatment, country, schedule, visit and visit by treatment interaction as fixed factors and with Baseline value and Baseline value by visit interaction as covariates with an unstructured covariance structure.|Baseline and Week 24|Full Analysis Set included all randomized participants who received at least 1 dose of study drug analyzed according to the treatment group to which they were randomized. A participant was included in the analyses when there was both a Baseline and at least 1 Post-baseline value at Week 24.||mg/dL||Standard Error|Least Squares Mean
681836|NCT01549964|Secondary|Incidence of HbA1c <7%|Incidence (percentage) of participants with glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) less than 7% at Week 24.|24 Weeks|Full Analysis Set included all randomized participants who received at least 1 dose of study drug analyzed according to the treatment group to which they were randomized||percentage of participants|||Number
681837|NCT01549964|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 24 relative to Baseline. A Mixed Model Repeated Measures (MMRM) model was used for analysis with treatment, country, schedule, visit and visit by treatment interaction as fixed factors and with Baseline value and Baseline value by visit interaction as covariates with an unstructured covariance structure.|Baseline and Week 24|Full Analysis Set included all randomized participants who received at least 1 dose of study drug analyzed according to the treatment group to which they were randomized. A participant was included in the analyses when there was both a Baseline and at least 1 Post-baseline value at Week 24.||Percent||Standard Error|Least Squares Mean
681838|NCT01549951|Secondary|Number of Participants Reporting Clinically Significant Abnormalities in ECG|The number of participants who reported clinically significant abnormalities in ECG were measured throughout study. ECGs were performed after the participant had been supine for at least 10 minutes.|Baseline up to 30 days after last dose of study drug (Day 86)|Safety analysis set was defined as all participants who received at least 1 dose of any study drug.||participants|||Number
681839|NCT01549951|Secondary|Number of Participants Reporting Clinically Significant Abnormalities in Physical Findings|Physical examination consists of examinations of the following body systems: (1) eyes; (2) ears, nose, throat; (3) cardiovascular system; (4) respiratory system; (5) gastrointestinal system; (6) dermatologic system; (7) extremities; (8) musculoskeletal system; (9) nervous system; (10) lymph nodes; and (11) physical examinations other than body systems described in (1) to (10).|Baseline up to 30 days after last dose of study drug (Day 86)|Safety analysis set was defined as all participants who received at least 1 dose of any study drug.||participants|||Number
681840|NCT01549951|Secondary|Number of Participants Reporting Clinically Significant Abnormalities in Vital Signs|The number of participants with any clinically significant abnormalities in vital signs collected throughout study. Vital signs included body temperature (oral), sitting blood pressure (after the participant has rested for at least 5 minutes), and pulse (bpm).|Baseline up to 30 days after last dose of study drug (Day 86)|Safety analysis set was defined as all participants who received at least 1 dose of any study drug.||participants|||Number
681841|NCT01549951|Secondary|Number of Participants Reporting Clinically Significant Abnormalities in Laboratory Values|The number of participants with any clinically significant abnormalities in safety laboratory values collected throughout study.|Baseline up to 30 days after last dose of study drug (Day 86)|Safety analysis set was defined as all participants who received at least 1 dose of any study drug.||participants|||Number
681842|NCT01549951|Secondary|Number of Participants Reporting One or More Treatment-emergent Adverse Events|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|Baseline up to 30 days after last dose of study drug (Day 86)|Safety analysis set was defined as all participants who received at least 1 dose of any study drug.||participants|||Number
681843|NCT01549951|Secondary|Cmax: Maximum Observed Plasma Concentration for Orteronel and M-I Metabolite|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. Average results at each time point were analyzed and a maximum across all post-dosing time points was used. Baseline is defined as the average of the triplicate 12-lead ECG measurements taken at the specified time prior to dosing.|Cycle 1 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose; Cycle 2 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose|PK population was defined as all participants who had sufficient dosing data and plasma concentration-time data to permit calculations of PK parameters.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
681844|NCT01549951|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Orteronel and M-I Metabolite|Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax. Average results at each time point were analyzed and a maximum across all post-dosing time points was used. Baseline is defined as the average of the triplicate 12-lead ECG measurements taken at the specified time prior to dosing.|Cycle 1 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose; Cycle 2 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose|PK population was defined as all participants who had sufficient dosing data and plasma concentration-time data to permit calculations of PK parameters.||hours||Full Range|Median
681853|NCT01549873|Secondary|Amplitude of the SSEPs|SSEPs (somatosensory evoked potentials) are most commonly elicited by bipolar transcutaneous electrical stimulation applied on the skin over the trajectory of peripheral nerves of the upper limb (e.g., the median nerve) or lower limb (e.g., the posterior tibial nerve), and then recorded from the scalp. The amplitude is the voltage of the electrical stimulation recorded.|day of surgery|||microvolt||Standard Deviation|Mean
681854|NCT01549873|Primary|Amplitude Required to Elicit the MEP|Compare the data obtained from neuromonitoring including the amplitude required to elicit the MEP from patients receiving general anesthesia with an inhalational anesthetic agent to those receiving total intravenous anesthesia (TIVA).|at time of surgery|||milliamperes||Standard Deviation|Mean
681845|NCT01549951|Secondary|AUC(0-6): Area Under the Plasma Concentration-Time Curve From Time 0 to 6 Hours Postdose for Orteronel and M-I Metabolite|AUC(0-6) is measure of area under the curve over the dosing interval (tau) (AUC(0-tau]), where tau is the length of the dosing interval - 6 hours in this study). Average results at each time point were analyzed and a maximum across all post-dosing time points was used. Baseline is defined as the average of the triplicate 12-lead ECG measurements taken at the specified time prior to dosing.|Cycle 1 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose; Cycle 2 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose|Pharmacokinetic (PK) population was defined as all participants who had sufficient dosing data and plasma concentration-time data to permit calculations of PK parameters.||nanogram hours per milliliter (ng*hr/mL)||Standard Deviation|Mean
681846|NCT01549951|Secondary|Correlation Between the QTcF Change From Baseline and Plasma Concentrations of Orteronel|Coefficient of correlation was measured using linear mixed effects model for the association between two variables; change from baseline versus the plasma concentration. Participant’s effects on the intercept and plasma concentration slope were included in the model as random effects terms. Plasma concentrations were re scaled for model convergence. Average results at each time point were analyzed and a maximum across all post-dosing time points was used. Baseline is defined as the average of the triplicate 12-lead ECG measurements taken at the specified time prior to dosing.|Cycle 1 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose; Cycle 2 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose|ECG analysis population was defined as all participants with at least 1 available baseline and at least 1 on-treatment ECG who received at least 1 dose of any study drug.||correlation coefficient||Standard Error|Least Squares Mean
681847|NCT01549951|Secondary|Number of Participants Reporting Change From Baseline in ECG Morphology|Participants with incidence of ECG morphology abnormalities were observed. Types of abnormalities included appearance of abnormal U waves, T waves inversion, elevation of ST segment, depression of ST segment, second or third degree heart block, right or left bundle branch block, atrial fibrillation/flutter, and myocardial infarction. New morphological changes were observed in abnormal U waves, depression of ST segment, and T waves inversion. Here, 'new' refers to change not present at baseline, ie, at any evaluation predose, and only seen postbaseline. Results of change in ECG morphology analyzed from 12-lead ECGs at each time point were averaged for analysis and a maximum across all post-dosing time points was used. Baseline is defined as the average of the triplicate 12-lead ECG measurements taken at the specified time prior to dosing.|Cycle 1 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose; Cycle 2 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose|ECG analysis population was defined as all participants with at least 1 available baseline and at least 1 on-treatment ECG who received at least 1 dose of any study drug.||participant|||Number
681848|NCT01549951|Secondary|Changes From Baseline in Heart Rate|Triplicate 12-lead Electrocardiogram (ECG) measurements were performed and average was calculated. Supine heart rate was measured as beats per minute (bpm). Results of change in heart rate analyzed from 12-lead ECGs performed at each time point were averaged for analysis and a maximum across all post-dosing time points was used. Baseline is defined as the average of the triplicate 12-lead ECG measurements taken at the specified time prior to dosing.|Cycle 1 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose; Cycle 2 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose|ECG analysis population was defined as all participants with at least 1 available baseline and at least 1 on-treatment ECG who received at least 1 dose of any study drug.||bpm||Standard Deviation|Mean
681849|NCT01549951|Secondary|Maximum Change From Baseline in QTc Based on the Bazett Correction (QTcB) Method, PR, QRS and Uncorrected QT Interval|Triplicate 12-lead ECG measurements (each recording separated by approximately 1 minutes) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Bazette’s formula (QTcB = QT divided by square root of RR). Results of change in QTcB, PR, QRS and uncorrected QT analyzed from 12-lead ECGs performed at each time point were averaged for analysis and a maximum across all post-dosing time points was used. Baseline is defined as the average of the triplicate 12-lead ECG measurements taken at the specified time prior to dosing.|Cycle 1 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose; Cycle 2 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose|ECG analysis population was defined as all participants with at least 1 available baseline and at least 1 on-treatment ECG who received at least 1 dose of any study drug.||msec||Standard Deviation|Mean
681850|NCT01549951|Primary|Maximum Change From Baseline in QTc Interval Based on the Fridericia Correction (QTcF) Method|Triplicate 12-lead electrocardiogram (ECG) measurements (each recording separated by approximately 1 minute) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia’s formula (QTcF = QT divided by cube root of RR). Results of change in QTcF analyzed from 12-lead ECGs performed at each time point were averaged for analysis and a maximum across all post-dosing time points was used. Baseline is defined as the average of the triplicate 12-lead ECG measurements taken at the specified time prior to dosing.|Cycle 1 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose; Cycle 2 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose|ECG analysis population was defined as all participants with at least 1 available baseline and at least 1 on-treatment ECG who received at least 1 dose of any study drug.||millisecond (msec)||Standard Deviation|Mean
681851|NCT01549925|Primary|Surgical Time|To evaluate whether the use of the LIGASURE surgical device during omentectomy and/or recto-sigmoid resection for women with ovarian cancer will reduce the surgical time compared to standard surgical resection using clamps and surgical ligatures|at time of surgery, up to 10 minutes|||SECONDS||95% Confidence Interval|Mean
681852|NCT01549873|Secondary|Latency of the SSEP’s|SSEPs (somatosensory evoked potentials) are most commonly elicited by bipolar transcutaneous electrical stimulation applied on the skin over the trajectory of peripheral nerves of the upper limb (e.g., the median nerve) or lower limb (e.g., the posterior tibial nerve), and then recorded from the scalp. Latency is the time interval between the stimulation and response.|day of surgery|||milliseconds||Standard Deviation|Mean
681855|NCT01549860|Secondary|Change in Pain VAS Scores|"Compare VAS Pain Scores between arms at baseline and 4 weeks post randomization
Subjects indicate their pain level by drawing a mark on a 10 cm line on a visual analog scale (VAS) at randomization and 4 week post treatment visit. The left end of the line indicates no pain and the right end of line indicates worst pain imaginable. VAS score is determined by using a ruler placed at 0 (left end of scale) and measuring the distance from zero to the patient's mark . The objective is to compare the change in VAS values in MIST+SC to SC alone.
H0: The average change in pain level is not different between MIST and SC HA: The average change in pain level is different between MIST and SC H0: µMIST = µSC vs HA: µMIST ≠ µSC,
Statistical Analysis. A repeated measures ANCOVA will be used to test for differences in change in VAS with an indicator variable to indicate treatment, any demographic variables which were significant in the baseline comparisons."|Baseline, 2 weeks and 4 weeks post randomization|Eligible Subjects Randomized||VAS pain level measured in centimeters||Full Range|Median
681856|NCT01549860|Secondary|Heal Rates|Compare rate of wound closure between study arms for 12 weeks post randomization. Descriptive statistics as not a powered endpoint.|12 weeks post randomization|Eligible subjects randomized||participants|||Number
681857|NCT01549860|Primary|Wound Area Mean Percent Reduction|"Compare between the treatment groups percent wound area reduction at four weeks of study treatment.
H0: µMIST+SC -- µSC = 0 HA: µMIST+SC -- µSC ≠ 0 Where µ = percent reduction in wound size."|4 weeks post baseline visit (randomization visit)|eligible subjects that were randomized||percentage of mean area reduction||Standard Deviation|Mean
681858|NCT01549613|Secondary|Digital and Infrared Imaging|Change in lesion area and temperature|Time frame begins on admission to RDTC for cellulitis and measurements will be taken every 2hour times 2 and every 4 hours until discharge from the RDTC.||||||
681859|NCT01549613|Primary|Satisfaction of Discharge Criteria|RDTC cellulitis protocol discharge criteria|Time point at which outcome measure is assessed 30 days from the date of admission.|||participants|||Number
681860|NCT01549405|Primary|Total Consumption of Tramadol Will be Measured for the First 24 Hours||Postoperative 24th hour|||mg||Standard Deviation|Mean
681861|NCT01549405|Secondary|Postoperative Pain Will be Evaluated.|The pain score (VAS)(visual analog scale) will be evaluated for the first 24 hours.(“0” no pain, to “10”, the maximum pain )Pain score less then 4 is acceptable.|24 hours|||units on a scale||Inter-Quartile Range|Median
681862|NCT01549405|Primary|Postoperative Analgesic (Tramadol) Consumption|Total consumption of tramadol will be measured for the first 24 hours.|Postoperative 24th hour||||||
681863|NCT01549392|Primary|3 Month Response|participants who had reduction of tumor size from avastin at 3 months|at 3 months after initial DECT and MR spectroscopy|||participants who had tumor reduction|||Number
681864|NCT01549340|Secondary|Duration of SCIT or SLIT Treatment for Participants With AR and Asthma or AR Alone|The mean duration in years of SCIT or SLIT treatment for all participants with AR and asthma and for all participants with AR only was calculated. Duration of SCIT or SLIT treatment was based on dates when allergy extract prescriptions were refilled.|Up to 5 years|The analysis population consisted of those participants with AR and asthma or AR alone who were advised by their physician to receive AIT to treat their AR and who initiated AIT.||years||Standard Deviation|Mean
681865|NCT01549340|Secondary|Percentage of Participants With a Co-morbidity of Asthma Who Initiated SCIT or SLIT|The percentage of participants who had AR and asthma and initiated SCIT or SLIT was calculated.|Up to 5 years|The analysis population consisted of those participants with AR and asthma who were advised by their physician to receive AIT to treat their AR and who initiated SCIT or SLIT.||percentage of participants|||Number
681866|NCT01549340|Primary|Reason for Discontinuation of SCIT or SLIT More Than 6 Months Before Completion of the Recommended Course|The reason for discontinuation of SCIT or SLIT treatment more than 6 months before completion of the recommended course of therapy was recorded. The percentage of participants whose records were reveiwed and who discontinued SCIT or SLIT due to different reasons was calculated.|Up to 5 years|The analysis population consisted of those participants with AR who were advised by their physician to receive AIT to treat their AR, who initiated and subsequently discontinued AIT, and had their charts reviewed for the reason for discontinuation.||percentage of participants|||Number
681867|NCT01549340|Primary|Duration of Treatment With SCIT or SLIT|The mean duration in years of SCIT or SLIT treatment for all participants with AR who initiated SCIT or SLIT was calculated. Duration of SCIT or SLIT was based on dates when allergy extract prescriptions were refilled.|Up to 5 years|The analysis population consisted of those participants with AR who were advised by their physician to receive AIT to treat their AR and who initiated AIT.||years||Standard Deviation|Mean
681868|NCT01549340|Primary|Percentage of Participants Who Initiated SCIT or SLIT and Completed 5 Years of Treatment|The percentage of participants who initiated SCIT or SLIT and completed 5 years of treatment was calculated. Duration of SCIT or SLIT was based on dates when allergy extract prescriptions were refilled. If extract refills continued past the recommended time for therapy (e.g. 5 years from the start of therapy), the participant was deemed successful in completing the recommended course. If the extract refills stopped prior to the end of the recommended time for therapy, but the last refill occurred within 6 months of the recommended time for therapy, this participant was deemed successful in completing the recommended course.|At 5 years|The analysis population consisted of those participants with AR who were advised by their physician to receive AIT to treat their AR and who initiated AIT.||percentage of participants|||Number
681869|NCT01549340|Primary|Percentage of Participants Advised to Start AIT Who Elected Subcutaneous Immunotherapy (SCIT) Shots or Sublingual Immunotherapy (SLIT) Drops|The percentage of participants who were advised by their physician to start AIT and elected to initiate AIT was calculated. AIT initiation was broken down by type of AIT initiated (SCIT or SLIT).|Up to 5 years|The analysis population consisted of those participants with AR who were advised by their physician to receive AIT to treat their AR.||percentage of participants|||Number
681870|NCT01549275|Secondary|Correlation Between the Growth Speeds of Cultured Cells and Worsening of AJCC TNM Stages or HCC Related Death 6 Months After Plating of Cells|104 Patients with complete follow-up data were further divided into receiving (1) curative treatment of HCC including operative resection and local ablation therapy, (2) palliative transcatheter arterial chemoembolization (TACE), and (3) supportive treatment.|6 months after plating of cells|Correlation between the growth speeds of cultured cells and worsening of AJCC TNM stages or HCC related death 6 months after plating of cells||participants|||Number
681871|NCT01549275|Primary|Correlation Between the Growth Speeds of the Cultured Cells and the AJCC TNM Stage (7th Eds) at Entering of the Study.|Patients were divided into AJCC TNM staging < = IIIA and > = IIIB two groups. The incidences of patients with rapidly proliferative cultured cells in these two groups were compared. Rapidly proliferative group was defined as (1) growth area of cultured cells at the 28th day of primary culture exceeded two times of the growth area measured at the 14th day, or (2) growth area of cultured cells at the 28th day reached > 70% growth area of the flask. Based on the results from special stain, patients in rapidly proliferative group were further divided into patients with rapid proliferation of HCC cells alone, rapid proliferation of HCC cells with concomitant cancer-associated fibroblasts (CAFs) (HCC + CAFs) and CAFs alone.|28 days after plating of cells|Comparison the incidence of patients with rapidly proliferative cultured cells between two groups||participants|||Number
681872|NCT01549223|Secondary|Side Effects (Hypotension, Flushing, Nausea and Emesis) Associated With Uterotonic Drug Use|Number of subjects experiencing hypotension, flushing, nausea, and emesis reported after administration of uterotonic agents.|Up to 15 min from time of infant delivery|All side effects: hypotension, flushing, nausea and emesis||Participants|||Count of Participants
681873|NCT01549223|Primary|1. Amount of Oxytocin to Obtain Satisfactory Uterine Tone.|Will measure total amount of oxytocin to achieve satisfactory uterine tone, as determined by the operating obstetrician.|Up to 15 min from time of infant delivery|||IU||Standard Deviation|Mean
681874|NCT01549041|Secondary|Change in Brief Psychiatric Rating Scale (BPRS) Total Score|The BPRS will be completed by the Principle Investigator at baseline and at day 14. The BPRS has 18 items each rated 1-7 with 1 representing the lowest severity of symptoms and 7 representing the highest severity; thus the lowest and highest possible total scores are 18 and 126|From baseline to day 14|||units on a scale||Standard Error|Mean
681875|NCT01549041|Primary|Patient Acceptance|A Patient Acceptance Likert Scale (1= Very Acceptable to 7 = Completely Unacceptable, i.e., individual refuses further doses) will be administered to the patient by the Research Nurse on day 14 of treatment.|At day 14|||units on a scale||Standard Error|Mean
681876|NCT01549002|Secondary|Score on Likert Scale for Patient Satisfaction|Patient satisfaction will be measured on a Likert scale just prior to Emergency Department discharge. If the patient is 8 years of age and older, both the patient and the parent or guardian will complete a satisfaction survey. If the patients is younger than 8 years, their parent or guardian will complete the satisfaction survey.|10 minutes after procedure completion||||||
681877|NCT01549002|Secondary|Score on the Faces Pain Scale Revised (FPS-R)|The Faces Pain Scale Revised (FPS-R) has been validated in patients 4 - 16 years of age undergoing painful procedures and will be used to assess patients' self reported pain. Patients will complete the FPS-R at four times during their medical encounter: (1) before analgesia administration, (2) ten minutes after analgesia administration but before beginning I&D, (3) immediately post I&D procedure (to ascertain the pain perceived during procedure), and (4) ten minutes after procedure completion.|Up to 10 minutes after procedure completion||||||
681878|NCT01549002|Primary|Score on the Observational Scale of Behavioral Distress Revised (OSBD-R)|Our primary outcome is the Observational Scale of Behavioral Distress - Revised (OSBD-R) to assess observed intra-procedural pain. The total OSBD-R score is a summation of the OSBD-R score of each individual phase. The score in each phase can range from 0 to 23.5. There were four phases in our study, so the range of scores for the total OSBD-R was 0 to 94, with a higher score indicating a greater degree of pain and distress. The scores documented here are the total OSBD-R scores.|Up to 10 minutes after the procedure completion|||units on a scale||Standard Deviation|Mean
681879|NCT01548885|Secondary|MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Low Glucose Range (<70mg/dL)|"Using fresh and glycolyzed samples with Blood Glucose(BG) below 70 mg/dL, the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI laboratory reference values were compared. MARD is calculated from the sum of all |(BG meter)-(BG reference)| / (BG Reference) assessments, divided by the number of assessments, then multiplied by 100(%). Each evaluable sample was tested on all five BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD value indicates smaller difference between meter value and the reference value . Higher MARD value indicates larger difference between meter value and the reference value."|10 hours|Same number (190) of BG results was possible for each BGMS. Subjects provided 1,2,or 3 capillary samples, of which 190 samples were less than 70 mg/dL.||percentage|Participants|95% Confidence Interval|Mean
681880|NCT01548885|Primary|MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Overall Tested Glucose Range|"Using the overall Blood Glucose(BG) range (24 to 386mg/dL), the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI laboratory reference values were compared. MARD is calculated from the sum of all |(BG meter)-(BG reference)| / (BG Reference) assessments, divided by the number of assessments, then multiplied by 100(%). Each evaluable sample was tested on all five BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD value indicates smaller difference between meter value and the reference value . Higher MARD value indicates larger difference between meter value and the reference value."|10 hours|Same number 388(393-3-2)BG results possible for each BGMS.Subjects provided 1,2,or 3 capillary samples-total 393 samples. 3 glycolyzed samples were not analyzed - glycolysis exceeded the protocol-defined time. All meter data for 2 glycolyzed samples were not evaluable (not analyzed)- their YSI results were less than the meter operating ranges.||percentage|Participants|95% Confidence Interval|Mean
681881|NCT01548833|Primary|Pre-Lens Non-Invasive Tear Break-Up Time (PL-NITBUT)|The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The time required for a dry spot to appear on the corneal surface after blinking is referred to as the tear film break-up time. Circular images were projected onto the corneal surface using a CA-1000 topographer, and the tear film reflection was observed on a 30-inch flat panel monitor. PL-NITBUT was recorded at the first sign of image distortion. Three measurements were taken and averaged together. A higher number represents a longer tear film break up time.|Day 7, 16 hours after lens insertion|||seconds||Standard Deviation|Mean
681882|NCT01548742|Other Pre-specified|Clinically Significant Improvement in Clinician Administered PTSD Scale (CAPS)|% of participants with clinically significant improvement in interviewer-rated PTSD symptom severity defined as a reduction of 10 points or more on the CAPS.|Weeks 9 and 17|Intent to treat analysis||percentage clinical responders||95% Confidence Interval|Number
681883|NCT01548742|Secondary|Depression Symptom Severity on the Patient Health Questionnaire-9 (PHQ-9) at Baseline, After Treatment, and at 2-Month Follow-up|The PHQ-9 is a valid and reliable measure of depression symptom severity. Score range from 0-27; higher scores indicate more severe symptoms. The minimal clinically important difference for self-reported PTSD symptom severity is a reduction of 5 or more points on the PHQ-9.|Baseline, Weeks 9 and 17|Intent to treat population (all participants randomized to treatment).||units on a scale||95% Confidence Interval|Mean
681884|NCT01548742|Secondary|PTSD Symptom Severity on the Clinician Administered PTSD Scale (CAPS) at Baseline, After Treatment, and at 2-Month Follow-up|The CAPS is a valid and reliable measure of PTSD symptom severity. Score range from 0-136; higher scores indicate more severe symptoms. The minimal clinically important difference for self-reported PTSD symptom severity is a reduction of 10 or more points on the CAPS.|Baseline, Weeks 9 and 17|Intent to treat population (all participants randomized to treatment).||units on a scale||95% Confidence Interval|Mean
681885|NCT01548742|Other Pre-specified|Clinically Significant Improvement in Self-reported PTSD Symptoms as Measured by the PCL|% of participants with clinically significant improvement in self-reported PTSD symptoms defined as a reduction of 10 points or more on the PCL.|Weeks 9 and 17|Intent to treat analysis||percentage clinical responders||95% Confidence Interval|Number
681886|NCT01548742|Primary|PTSD Symptoms on the PTSD Checklist (PCL) at Baseline, During Treatment, After Treatment and at 2-Month Follow-up|The PCL is a valid and reliable measure of PTSD symptoms. Score range from 17-85; higher scores indicate more severe symptoms. The minimal clinically important difference for self-reported PTSD symptom severity is a reduction of 10 or more points on the PCL.|Baseline, Weeks 3, 6, 9 and 17|Intent to treat population (all participants randomized to treatment).||units on a scale||95% Confidence Interval|Mean
681887|NCT01548638|Secondary|Side Effects of Galantamine|"Side effects of galantamine were assessed at the following in-person sessions: Baseline session, Days 7, 14, 21, and 28 (brief monitoring visits), Day 35 (Day before Target Quit Day), and Days 37, 39, and 43 (during the 7-day quit attempt). A 37-item checklist of side effects based on the product insert (e.g., Nausea, Vomiting, Diarrhea, Loss of appetite, Stomach pain, Constipation, Gastroesophageal Reflux Problems (Heartburn)) was administered to participants at all study visits after the Intake. An open-ended side effects question was also be included.
Items were measured on a scale from 0 (None) to 3 (Severe).
The side effect summary score (total side effects averaged from the 37 item checklist) at each visit is reported below. Each score ranges from 0 (None) to 3 (Severe)."|Days 7, 14, 21, 28, 35, 37, 39, and 43; Baseline session|||units on a scale||Standard Deviation|Mean
681888|NCT01548638|Secondary|Subjective Symptoms - Smoking Behavior, Urges, Mood, Nicotine Withdrawal|The subjective symptoms listed above will be assessed at the following in-person sessions: Baseline session, Days 7, 14, 21, and 28 (brief monitoring visits), Day 35 (Day before Target Quit Day), and Days 37, 39, and 43 (during the 7-day quit attempt).|Days 7, 14, 21, 28, 35, and 43; Baseline session||||||
681889|NCT01548638|Secondary|Cognitive Performance: Working Memory Accuracy|"Participants will complete neurocognitive test designed to test working memory and attention and are similar to computer games, in that participants will push a button in response to the pictures they see. Working memory was measured using a computerized N-back task. During the N-back, participants are instructed to remember the location of a stimulus, a grey circle that is approximately 5 cm in diameter, as it appears randomly in 8 possible locations around the perimeter of a computer screen. Stimulus duration is 200 ms, followed by an interstimulus interval (ISI) of 2800 ms. The N-back task includes 4 conditions of varying difficulty levels: the 0-back, 1-back, 2-back, and 3-back.
Number of correct responses (true positives) is described below.
The maximum number of correct responses is 60."|At Baseline (Day 0), Day 35 (Day before Target Quit Day), and Day 43|||correct responses||Standard Deviation|Mean
681890|NCT01548638|Secondary|Cognitive Performance: Working Memory Reaction Time|"Participants will complete neurocognitive test designed to test working memory and attention and are similar to computer games, in that participants will push a button in response to the pictures they see. Working memory was measured using a computerized N-back task. During the N-back, participants are instructed to remember the location of a stimulus, a grey circle that is approximately 5 cm in diameter, as it appears randomly in 8 possible locations around the perimeter of a computer screen. Stimulus duration is 200 ms, followed by an interstimulus interval (ISI) of 2800 ms. The N-back task includes 4 conditions of varying difficulty levels: the 0-back, 1-back, 2-back, and 3-back.
Median reaction time to correct responses is described below.
Typical responses range from 250 ms to 1500 ms."|At Baseline (Day 0), Day 35 (Day before Target Quit Day), and Day 43|||ms||Standard Deviation|Mean
681891|NCT01548638|Primary|Number of Days of Abstinence During a 7-day Quit Attempt|Participants will undergo a 6-week study medication period. Day 36 will be the beginning of a 7-day practice quit attempt, during which number of days of abstinence will be assessed.|Days 36-43; following a 5-week dose run-up|||days||Full Range|Mean
681892|NCT01548573|Secondary|Overall Survival|To determine the median overall survival based on an intent-to-treat analysis, which should exceed 10 years, based on the projected 10-year survival of Total Therapy III, keeping in mind that participants are included in this protocol with up to 12 months of prior therapy.|10 years|"Enrollment halted prematurely. Study met stopping rules (3 or more of the first 20 participants died due to treatment-related toxicity).
Data for outcome measure 4 were not collected."|||||
681893|NCT01548573|Secondary|Number of Grade 3 Non-hematologic and Grade 4 Hematologic Serious Adverse Events Associated With the Addition of Bortezomib, Thalidomide, and Dexamethasone Into Autologous Transplant Regimens.|To determine whether bortezomib, thalidomide and dexamethasone with transplant 1 and velcade/gemcitabine with transplant 2 can be safely incorporated into well-tested pre-transplant regimens of high-dose melphalan and carmustine/melphalan in doses equivalent to the BEAM(BCNU, etoposide, arabinoside, melphalan)regimen. Treatment-related toxicities will be compared to those reported in the literature using similar intensive approaches.|2 years|"Enrollment halted prematurely. Study met stopping rules (3 or more of the first 20 participants died due to treatment-related toxicity).
Data for outcome measure 3 were not collected."|||||
681894|NCT01548573|Primary|Identification of Drug Resistant Genes|To determine whether repeated bone marrow samples analyzed for gene expression profiling (GEP) can identify genes related to drug resistance in myeloma. The drug resistant genes or the gene products might then be targeted specifically to eradicate myeloma cells surviving tandem transplantation.|5 years|"Enrollment halted prematurely. Study met stopping rules (3 or more of the first 20 participants died due to treatment-related toxicity).
Data for outcome measure 2 were not collected."|||||
681895|NCT01548573|Primary|Event-Free Survival (EFS)|To determine whether, in comparison to Total Therapy II, the median Event-Free Survival (EFS) can be increased from 4.8 years to 7.2 years, which represents an increase in median EFS of approximately 50%, based on an intent-to-treat analysis.|8 years|"Enrollment halted prematurely. Study met stopping rules (3 or more of the first 20 participants died due to treatment-related toxicity).
Data for outcome measure 1 were not collected."|||||
681896|NCT01548417|Secondary|Drinking|Number of standard drinks per week using the Timeline Followback Interview. Total number of alcoholic drinks consumed per week with a minimum value of 0 and a maximum value of 70.|2 weeks|Three randomized subjects who met exclusionary criteria were not included in the regression analysis for drinking: two subjects were excluded for unreliable reporting and one subject was excluded for being treatment seeking.||alcoholic drinks per week||Standard Error|Mean
681897|NCT01548417|Primary|Craving to Drink|Visual Analog Scale (VAS) scores of craving severity in response to in vivo alcohol cues. Higher scores indicate greater craving severity with a minimum score of 0 and a maximum score of 80.|1 week|1 participant who completed the study had missing VAS scores.||units on a scale||Standard Error|Mean
681898|NCT01548287|Secondary|Change From Baseline in Sleep Efficiency After 4 Weeks of Treatment, Based on Actigraphy Recording.|Change from baseline in sleep efficiency after 4 weeks of treatment, based on participants with valid baseline and week 4 actigraphy data|Baseline and Week 4.|Subset of Primary Analysis Population with valid actigraphy data||% (efficiency=% of time asleep)||90% Confidence Interval|Least Squares Mean
681899|NCT01548287|Secondary|Change From Baseline in Latency of Persistent Sleep After 4 Weeks of Treatment, Based on Actigraphy Recording.|Change from baseline in latency of persistent sleep after 4 weeks of treatment, based on participants with valid baseline and week 4 actigraphy data|Baseline and Week 4.|Subset of Primary Analysis Set with valid actigraphy data||Minutes||90% Confidence Interval|Least Squares Mean
681900|NCT01548287|Secondary|Change From Baseline in Night Total Sleep Time After 4 Weeks of Treatment, Based on Actigraphy Recording.|Change from baseline in night total sleep time after 4 weeks of treatment: assessed if valid baseline and week 4 actigraphy data|Baseline and Week 4.|Subset of Primary Analysis Set with valid actigraphy data||Minutes||90% Confidence Interval|Least Squares Mean
681901|NCT01548287|Secondary|Change From Baseline in Latency to Persistent Sleep After 4 Weeks of Treatment, Based on PSG Measurements.||Baseline and Week 4.|Primary analysis set||Rank transformed duration (minutes)||90% Confidence Interval|Least Squares Mean
681902|NCT01548287|Secondary|Change From Baseline in Sleep Efficiency After 4 Weeks of Treatment, Based on PSG Measurements.||Baseline and Week 4.|Primary analysis set||% change||90% Confidence Interval|Least Squares Mean
681903|NCT01548287|Primary|Change From Baseline in Total Sleep Time (TST) After 4 Weeks of Treatment, Based on PSG Measurement.|Total sleep time (TST) is defined as the total time in minutes, that subjects were determined to be in a sleep state by polysomnography (PSG) measurement.|Baseline and Week 4.|Primary analysis set||Minutes||90% Confidence Interval|Least Squares Mean
681904|NCT01547806|Secondary|Impact of Plerixafor in the Degree of Tumor Cell Contamination in the Final Product|Flow cytometry to detect tumor contamination.|Day 1 of apheresis|Because no data from any participant was sufficiently collected to assess tumor cell contamination, we were not able to determine the effect of plerixafor on this parameter.|||||
681905|NCT01547806|Secondary|Degree of Tumor Cell Contamination in the Final Product|Flow cytometry to detect tumor contamination.|Day 1 of apheresis|No data from any participant was sufficiently collected to assess tumor cell contamination.|||||
681906|NCT01547806|Secondary|Percentage of Patients That Achieved ≥ 2 x 10^6 But Less Than 5 x 10^6 Cluster of Differentiation 34 (CD34) Cells/kg (Day One Collection)|Percentage of patents achieving collecting the minimum but not optimal CD34 cell number.|Day one of collection|||percentage of patients|||Number
681907|NCT01547806|Secondary|Percentage of Patients That Achieved or Did Not Achieve 5 x 10^6 Cluster of Differentiation 34 (CD34) Cells/kg|Here is the percentage of patients that achieved or did not achieve 5 x 10^6 CD34 cells/kg in a single apheresis.|Through Day 2 of collection|||percentage of patients|||Number
681908|NCT01547806|Secondary|Percentage of Patients That Required Plerixafor + Granulocyte-colony Stimulating Factor (G-CSF) And Only G-CSF (no Plerixafor)|Percentage of patients that required Plerixafor injection in addition to G-CSF mobilization or none at all|One week of mobilization therapy|||percentage of patients|||Number
681909|NCT01547806|Secondary|Number of Participants With Serious and Non-Serious Adverse Events|Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|27 months and 27 days|||Participants|||Count of Participants
681910|NCT01547806|Primary|Number of Hematopoietic Progenitor Cell (HPC) Apheresis Products Collected and Cryopreserved for Subsequent Use in Autologous Hematopoietic Cell Transplantation (AHCT) in Subjects With Plasma Cell Myeloma (PCM)|The cryopreserved stem cells are stored under Good Manufacturing Practice (GMP) conditions in the National Institutes of Health (NIH) Department of Transfusion Medicine until a referring physician requests the products for standard clinical care.|Indefinitely until a referring physician requests the product for standard clinical care or until product(s) is no longer needed and disposed of|||products|||Number
681911|NCT01547806|Primary|25th and 75th Percentile Values of Cluster of Differentiation 34 (CD34) Cells Collected|Progenitor cells by apheresis was determined by flow cytometry.|Through Day 2 of collection|||Number of CD34 cells per kg/BW (x 10EE6)|||Number
681912|NCT01547806|Primary|Range of Cluster of Differentiation 34 (CD34) Cells Collected|Progenitor cells by apheresis was determined by flow cytometry.|Through Day 2 of collection|||Number of CD34 cells per kg/BW (x 10EE6)||Full Range|Median
681913|NCT01547806|Primary|Median and Standard Deviation of Cluster of Differentiation 34 (CD34) Cells Collected (Per Kg Recipient Body Weight) (BW)|Progenitor cells by apheresis was determined by flow cytometry.|Through Day 2 of collection|||Number of CD34 cells per kg/BW (x 10EE6)||Standard Deviation|Median
681916|NCT01547806|Primary|Percentage of Patients Achieving at Least 2 x 10^6 Cluster of Differentiation 34 (CD34) Cells Per Kg Recipient Body Weight on Day 1 of Apheresis|Progenitor cells by apheresis was determined by flow cytometry. The stated goal was a minimum dose of 2x10EE^6/kg following apheresis.|Day 1 of apheresis|||percentage of patients|||Number
681917|NCT01547728|Primary|Percentage of Patients Whose Activated Clotting Time (ACT) is Prolonged Beyond 480 Seconds With Recombinant Human Antithrombin Concentrate (rhAT) Administration|Restored antithrombin level is defined as an activated clotting time > 480 seconds 3 minutes after the initial dose of 500 units of rhAT is administered. The percentage of patients who meet this criterion will be summarized using a point estimate and a 95% confidence interval.|3 minutes after the initial dose of rhAT, Day 1 of the study|The study was terminated because there were too many barriers to enroll participants.|||||
681918|NCT01547715|Secondary|Number of Subjects With Unsolicited Adverse Events|The safety of one dose of MenACWY –CRM was assessed in terms of the number of subjects reporting unsolicited adverse events. All AEs were recorded from day 1 to day 7; SAE, medically attended AEs and AEs Leading to premature withdrawal were recorded throughout the entire study period.|Day 1 through day 29|The analysis was performed on the safety analysis dataset.||participants|||Number
681919|NCT01547715|Secondary|Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination|The safety of one dose of MenACWY – CRM was assessed in terms of the number of subjects reporting solicited local and systemic reactions.|From day 1 to Day 7 post vaccination|The analysis was performed on the safety analysis set.||Participants|||Number
681920|NCT01547715|Secondary|Number of Subjects Who Reported Any Solicited Local and Systemic Reactions Post Vaccination|The safety of one dose of MenACWY – CRM was assessed in terms of the number of subjects reporting any solicited local and systemic reactions.|From day 1 to Day 7 post vaccination|The analysis was performed on the safety analysis set, ie, all subjects in the exposed population who provided any post-baseline safety data.||Participants|||Number
681921|NCT01547715|Secondary|hSBA GMTs Directed Against N.Meningitidis Serogroup Y at Day 29|To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup Y at day 29.|Day 29 (ie, 1 month post vaccination)|Analysis was done on the FAS.||Titer||95% Confidence Interval|Geometric Mean
681922|NCT01547715|Secondary|hSBA GMTs Directed Against N.Meningitidis Serogroup Y at Day 1|To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup Y at day 1.|Day 1|Analysis was done on the FAS.||Titer||95% Confidence Interval|Geometric Mean
681923|NCT01547715|Secondary|hSBA GMTs Directed Against N.Meningitidis Serogroup W at Day 29|To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup W at day 29.|Day 29 (ie, 1 month post vaccination)|Analysis was done on the FAS.||Titer||95% Confidence Interval|Geometric Mean
681924|NCT01547715|Secondary|hSBA GMTs Directed Against N.Meningitidis Serogroup W at Day 1|To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup W at day 1.|Day 1|Analysis was done on the FAS.||Titer||95% Confidence Interval|Geometric Mean
681925|NCT01547715|Secondary|hSBA GMTs Directed Against N.Meningitidis Serogroups C at Day 29|To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup C at day 29.|Day 29 (ie, 1 month post vaccination)|Analysis was done on the FAS.||Titer||95% Confidence Interval|Geometric Mean
681926|NCT01547715|Secondary|hSBA GMTs Directed Against N.Meningitidis Serogroups C at Day 1|To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup C at day 1.|Day 1|Analysis was done on the FAS.||Titer||95% Confidence Interval|Geometric Mean
681927|NCT01547715|Secondary|hSBA GMTs Directed Against N.Meningitidis Serogroup A at Day 29|To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup A at day 29.|Day 29 ( ie, 1 month post vaccination)|Analysis was done on the FAS.||Titer||95% Confidence Interval|Geometric Mean
681928|NCT01547715|Secondary|hSBA Geometric Mean Titers (GMTs) Directed Against N.Meningitidis Serogroup A at Day 1|To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup A at day 1.|Day 1|Analysis was done on the FAS.||Titer||95% Confidence Interval|Geometric Mean
681929|NCT01547715|Secondary|Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup Y at Day 29|To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup Y at day 29.|Day 29 (ie, 1 month post vaccination)|Analysis was done on the FAS.||Percentages of subjects||95% Confidence Interval|Number
681930|NCT01547715|Secondary|Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup Y at Day 1|To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup Y at day 1.|Day 1|Analysis was done on the FAS.||Percentages of subjects||95% Confidence Interval|Number
681931|NCT01547715|Secondary|Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup W at Day 29.|To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup W.|Day 29|Analysis was done on the FAS.||Percentage||95% Confidence Interval|Number
681932|NCT01547715|Secondary|Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup W at Day 1.|To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup W at day 1.|Day 1|Analysis was done on the FAS.||Percentages of subjects||95% Confidence Interval|Number
681933|NCT01547715|Secondary|Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup C at Day 29.|To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup C at day 29.|Day 29 (ie, 1 month post vaccination)|Analysis was done on the FAS.||Percentages of subjects||95% Confidence Interval|Number
681934|NCT01547715|Secondary|Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup C at Day 1.|To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup C at day 1.|Day 1|Analysis was done on the FAS.||Percentages of subjects||95% Confidence Interval|Number
681935|NCT01547715|Secondary|Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup A at Day 29.|To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup A at day 29.|Day 29 (ie, 1 month post vaccination)|Analysis was done on the FAS.||Percentages of subjects||95% Confidence Interval|Number
681936|NCT01547715|Secondary|Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup A at Day 1.|To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup A at day 1.|Day 1|Analysis was done on the FAS||Percentage of subjects||95% Confidence Interval|Number
681937|NCT01547715|Primary|Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup Y.|The immunogenicity of a single injection of MenACWY-CRM vaccine is assessed in terms of percentage of subjects with hSBA seroresponse directed against N.meningitidis serogroup Y.|Day 29 (1 month post vaccination)|Analysis was done on the FAS.||Percentages of subjects||95% Confidence Interval|Number
681938|NCT01547715|Primary|Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup W.|The immunogenicity of a single injection of MenACWY-CRM vaccine is assessed in terms of percentage of subjects with hSBA seroresponse directed against N.meningitidis serogroup W.|Day 29 (1 month post vaccination)|Analysis was done on the FAS.||Percentages of subjects||95% Confidence Interval|Number
681939|NCT01547715|Primary|Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup C|The immunogenicity of a single injection of MenACWY-CRM vaccine is assessed in terms of percentage of subjects with hSBA seroresponse directed against N.meningitidis serogroup C.|Day 29 (1 month post vaccination)|Analysis was done on the FAS.||Percentages of subjects||95% Confidence Interval|Number
681940|NCT01547715|Primary|Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup A.|The immunogenicity of a single injection of MenACWY-CRM vaccine is assessed in terms of percentage of subjects with hSBA seroresponse directed against N.meningitidis serogroup A.|Day 29 (1 month post vaccination)|Analysis was done on the Full Analysis Set (FAS), ie, all subjects in the exposed population who provided at least one evaluable serum sample whose assay result is available for at least one serogroup.||Percentages of subjects||95% Confidence Interval|Number
681941|NCT01547598|Secondary|Change From Baseline in Mean IOP at Week 6|IOP is a measurement of the fluid pressure inside the eye. IOP of the study eye (worse eye) was measured at 8 AM, 12 Noon and 4 PM at Week 6. For each eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements. A negative change from Baseline indicated improvement.|Baseline, Week 6|Participants from the Full Analysis Set IOP population, all randomized participants who received at least one dose of study treatment and met study inclusion criteria, with IOP data available for analysis at the given time-point.||mmHg||Standard Deviation|Mean
681942|NCT01547598|Secondary|Percentage of Participants With Mean Diurnal IOP Less Than 18 mmHg|IOP is a measure of the fluid pressure in the eye. The mean diurnal IOP was the average of the IOP values of the study eye (worse eye) at Week 12 measured at 8 AM, 12 Noon and 4 PM. For each eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements.|Week 12|Participants from the mITT population, all randomized participants who received at least one dose of study treatment and met inclusion criteria, with data available for analysis.||percentage of participants|||Number
681943|NCT01547598|Secondary|Percentage of Participants With ≥15% Reduction in Mean Diurnal IOP From Baseline|IOP is a measurement of the fluid pressure in the eye. The mean diurnal IOP was the average of the IOP values of the study eye (worse eye) measured at 8 AM, 12 Noon and 4 PM. For each eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements.|Baseline, Week 12|Participants from the mITT population, all randomized participants who received at least one dose of study treatment and met inclusion criteria, with data available for analysis.||percentage of participants|||Number
681944|NCT01547598|Secondary|Change From Baseline in Mean IOP at Week 12|IOP is a measurement of the fluid pressure inside the eye. IOP of the study eye (worse eye) was measured at 8 AM, 12 Noon and 4 PM at Week 12. For each eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements. A negative change from Baseline indicated improvement.|Baseline, Week 12|Participants from the Full Analysis Set IOP population, all randomized participants who received at least one dose of study treatment and met study inclusion criteria, with IOP data available for analysis at the given time-point.||mmHg||Standard Deviation|Mean
681945|NCT01547598|Primary|Mean Diurnal Intraocular Pressure (IOP)|IOP is a measurement of the fluid pressure inside the eye. The mean diurnal IOP was the average of the IOP values of the study eye (worse eye) at Week 12 measured at 8 AM, 12 Noon and 4 PM. For each study eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements.|Week 12|Participants from the modified Intent-to-treat (mITT) population, all randomized participants who received at least one dose of study treatment and met inclusion criteria, with data available for analysis.||mmHg||Standard Deviation|Mean
681992|NCT01546922|Secondary|Change in Quality of Life After 10 Weeks of Treatment With a Low Dose of Hydrocortisone Compared to 10 Weeks of Treatment With a High Dose of Hydrocortisone.|Quality of life questionnaires have to be filled in by the participant at his/her home place and have to be returned by post.|After completion of treatment period 1 (that is after 10 weeks from baseline) and after treatment period 2 (that is after 20 weeks from baseline).||||||
681977|NCT01547286|Secondary|Coefficient of Variation Squared of Perfusion|Coefficient of variation squared of the perfusion in the imaged lung. This measures the overall heterogeneity of perfusion in the imaged lung.|7 hours after allergen administration||||||
681978|NCT01547286|Secondary|Coefficient of Variation Squared of Perfusion|Coefficient of variation squared of the perfusion in the imaged lung. This measures the overall heterogeneity of perfusion in the imaged lung.|3 hours after allergen administration||||||
681979|NCT01547286|Primary|Percentage Change in the Ratio of Mean-normalized Perfusion Within Ventilation Defective Regions Relative to Outside|Blood flow relative to the mean blood flow of the lung (mean normalized perfusion) inside areas that have reduced ventilation (Vdefs) relative to outside the Vdefs. Or, another way of writing this is: (Blood flow inside Vdefs/mean blood flow of the lung)/(Blood flow outside Vdefs/mean blood flow of the lung).|7 hours after allergen administration|||percentage||Standard Deviation|Mean
681980|NCT01547286|Primary|Percentage Change in the Ratio of Mean-normalized Perfusion Within Ventilation Defective Regions Relative to Outside|Blood flow relative to the mean blood flow of the lung (mean normalized perfusion) inside areas that have reduced ventilation (Vdefs) relative to outside the Vdefs. Or, another way of writing this is: (Blood flow inside Vdefs/mean blood flow of the lung)/(Blood flow outside Vdefs/mean blood flow of the lung).|3 hours after allergen administration|||percentage||Standard Deviation|Mean
681981|NCT01547247|Secondary|Success Rate of Minimal Sedation Colonoscopy|A successful minimal sedation colonoscopy was defined as reaching the cecum without switching to another insertion method and without additional sedation beyond the initial 2 mg of midazolam.|3 months|||percentage of all subjects in arm|||Number
681982|NCT01547247|Secondary|Patient Comfort During Insertion Phase of the Colonoscopy||3 months||||||
681983|NCT01547247|Primary|Cecal Intubation Time|The primary endpoint (cecal intubation time) was defined as a time between introduction of the colonoscope into the anus and reaching the cecum.|3 months|Statistical power was calculated for the primary endpoint. A sample size of 93 subjects per arm was calculated using two-tailed alfa 0.05, beta 0.2, assuming that difference 20 % in intubation times would have been clinically relevant.||minutes||95% Confidence Interval|Number
681984|NCT01547130|Secondary|Total Preparation Time|Patients in both groups were provided with a questionnaire to record the total time required from start of assigned prep to completion of the prep.|Upto 24 weeks|Patients in both groups were provided with a questionnaire to record the total time required from start of assigned prep to completion of the prep.||hours||Full Range|Mean
681985|NCT01547130|Secondary|Patient-reported Adverse Events.|Patients from both groups reported adverse events in a symptom questionnaire.|Upto 24 weeks|Patients from both groups reported adverse events in a symptom questionnaire.||participants|||Number
681986|NCT01547130|Secondary|Subjective Grading by Patients on Willingness to Repeat the Large Bowel Preparation.|"Subjects rated the SCC as Willingness to repeat the same prep in future"|Upto 24 weeks|Patients completed a questionnaire where they rated willingness to repeat the preps on a 1-5 Likert scale.||participants|||Number
681987|NCT01547130|Secondary|Palatability of Bowel Prep|"Patients completed a symptom questionnaire where they rated solution palatability of their assigned prep on a 1-5 Likert scale. A rating of more than 3 was considered as Palatable."|Upto 24 weeks|All subjects enrolled and completed the bowel preparation. .||participants|||Number
681988|NCT01547130|Primary|Efficacy of Large Bowel Cleansing as Assessed by the Physician Performing the Colonoscopy|The primary endpoint was the “success” rate of the preparations. Preparation efficacy was evaluated by a single, blinded endoscopist (V.A.), who performed all of the colonoscopies. The evaluation involved the rating of six anatomical segments of the colon (rectum, sigmoid, descending colon, transverse colon, ascending colon and cecum) on the 5 point Arya Bowel Prep Scale (ABPS). Aggregating the segmental scores resulted in overall scores. Grade A was defined as a total overall score of 19–24, grade B as a score of 13–18, grade C as a score of 7–12, and grade D as a score of 0–6. Grade A or B preparation was considered “successes”, while grade C or D was considered “failures.” To assess the reliability of ABPS, we trained 4 gastroenterologists and 3 fellows.|Within 48 hours of bowel preparation|The non-inferiority margin was set at -15%. This means the intervention will be considered non-inferior if the difference in success rates is less than 15%. The study was designed to have 90% power to establish non-inferiority when the two treatment groups are equivalent using a one-tailed test at the 5% significance level.||Score||Standard Deviation|Mean
681989|NCT01546922|Secondary|Change in Perceived Common Somatic Complaints After 10 Weeks of Treatment With a Low Dose of Hydrocortisone Compared to 10 Weeks of Treatment With a High Dose of Hydrocortisone.|The patients report common somatic complaints by filling in structured daily diaries.|during treatment period 1 (that is from week 1 to week 10 from baseline) and during treatment period 2 (that is from week 11 to week 20 from baseline).||||||
681990|NCT01546922|Secondary|Change in Somatosensation After 10 Weeks of Treatment With a Low Dose of Hydrocortisone Compared to 10 Weeks of Treatment With a High Dose of Hydrocortisone.|Measures of somatosensation: the mechanical detection threshold, the mechanical pain threshold, mechanical pain sensitivity, dynamic mechanical allodynia, wind up ratio and the pressure pain threshold.|After completion of treatment period 1 (that is after 10 weeks from baseline) and after treatment period 2 (that is after 20 weeks from baseline).||||||
681991|NCT01546922|Secondary|Change in Metabolic Profile After 10 Weeks of Treatment With a Low Dose of Hydrocortisone Compared to 10 Weeks of Treatment With a High Dose of Hydrocortisone.|Cardiovascular and metabolic risk factors, (pituitary) hormones and bone markers.|After completion of treatment period 1 (that is after 10 weeks from baseline) and after treatment period 2 (that is after 20 weeks from baseline).||||||
681993|NCT01546922|Primary|Change in Cognition After 10 Weeks of Treatment With a Low Dose of Hydrocortisone Compared to 10 Weeks of Treatment With a High Dose of Hydrocortisone.|"Cognitive domains to be tested: memory, executive functioning, attention and social cognition.
The psychological tests consist of oral and written questions or computer tasks.
Data is given as Z-scores based on normative data. Higher Z-scores represent a better performance."|After completion of treatment period 1 (that is after 10 weeks from baseline) and after treatment period 2 (that is after 20 weeks from baseline).|The participants completing both study periods were analyzed||Z-scores based on normative data.||Standard Deviation|Mean
681994|NCT01546883|Primary|Percentage of Fibrosis|We will measure the change in percentage of fibrosis over a one-year period when drug is taken. We will calculate the results as percentage of fibrosis measured using MRI at 12 months minus the percentage of fibrosis measured using MRI at baseline to clarify if there is a decrease in fibrosis in the one year period.|MRI at baseline and MRI at 12 months post-enrollment|Data were not collected for the analysis population and therefore could not be summarized to include in this report.|||||
681995|NCT01546688|Secondary|Percentage of Responders During Last 28 Days of Maintenance Period|Seizure frequency was assessed by a seizure diary, maintained daily from Baseline, in which the subject recorded the occurrence of any seizure. A responder is a subject who had at least a 50 percent or greater reduction in the seizure frequency of all seizures during the last 28 days of the Maintenance Period compared to the Baseline Period seizure frequency. Due to the exploratory nature of the objective for efficacy and the truncated study size, analysis of efficacy was based on observed cases, without imputation for missing data. As a result, there are some variations in sample sizes for efficacy at different visits, depending on if particular efficacy variables were missing for particular visits.|Baseline and Month 4|Intent-to-Treat Population. Percentages are based on the number of subjects present in the Maintenance Phase.||Percentage of Participants|||Number
681996|NCT01546688|Secondary|Percent Change in Seizure Frequency From Baseline to the Last 28 Days of the Maintenance Period|Seizure frequency was assessed by a seizure diary, maintained daily from Baseline, in which the subject recorded the occurrence of any seizure.|Baseline and Month 4|Intent-to-Treat Population.||Percent Change||Full Range|Median
681997|NCT01546688|Primary|Change From Baseline in Bond and Lader Visual Analogue Scale (VAS) Mood Sub-Scores for Sedation by Visit During Titration and Maintenance Period|The Bond-Lader mood rating scale measured sedation, with scores ranging from 0 to 100. A high score reflects a high level of sedation.|Baseline, Week 4, Week 8, Week 12, Week 16|Intent-to-Treat Population||Scores on a Scale||Standard Deviation|Mean
681998|NCT01546688|Primary|Change From Baseline in CVST of the FePsy Test (Mean Reaction Time) by Visit During Titration and Maintenance Period|The Computer Visual Search Task (CVST) of the Ferrum Psyche (FePsy)measured cognition. A decrease from Baseline (negative change value) signifies an improvement in the mean reaction time of CVST.|Baseline, Week 4, Week 8, Week 12, Week 16|Intent-to-Treat Population: All randomized subjects who received at least one dose of study medication.||Seconds||Standard Deviation|Mean
681999|NCT01546675|Secondary|Prosthetic Evaluation Questionnaire (PEQ) - Residual Limb Health Subscale|The 6-item residual limb health scale includes items about the bothersome of sweating, smell, swelling, ingrown hairs, rashes and blisters. All items were scored using a 1 to 7 Likert scale average with lower scores indicated worse ratings and higher scores indicated better ratings. The scores for each item were added and the total score was the average of scores for all items, thus scores could range from 1 to 7.|After 4 weeks of home use (2 weeks for each socket style)|||units on a scale|||Number
682000|NCT01546675|Primary|Degrees of Shoulder Displacement Within the Prosthetic Socket|A shoulder shrug task was achieved by pulling up on a strap attached to the load cell, which was mounted on the vertical face of the concrete pedestal. Skeletal and socket kinematics were calculated using the markerless auto-registration algorithm and X-Ray Reconstruction of Moving Morphology (XROMM)|After 4 weeks of home use (2 weeks for each socket style)|||degrees|||Number
682001|NCT01546675|Primary|Degrees of Shoulder Internal Rotation Within the Prosthetic Socket|Isometric internal rotation was performed with the prosthetic elbow flexed to 90 degrees and shoulder in neutral position. Skeletal and socket kinematics were calculated using the markerless auto-registration algorithm and X-Ray Reconstruction of Moving Morphology (XROMM)|After 4 weeks of home use (2 weeks for each socket style)|||degrees|||Number
682002|NCT01546675|Secondary|Prosthetic Evaluation Questionnaire (PEQ) - Utility Subscale|The 8-item utility subscale includes items related to prosthetic socket utility including: comfort, fit, ease of donning and doffing and feel on the residual limb. All items were scored using a 1 to 7 Likert scale average with lower scores indicated worse ratings and higher scores indicated better ratings. The scores for each item were added and the total score was the average of scores for all items, thus scores could range from 1 to 7.|after 2 weeks of home use of each socket type|||units on a scale|||Number
682003|NCT01546675|Secondary|Trinity Amputations and Prosthetics Experience Satisfaction Scale (TAPES)|This 10 item scale includes items related to satisfaction with aspects of the prosthesis. It includes questions about extent of satisfaction regarding functional characteristics of the artificial limb: reliability, comfort, fit, and overall satisfaction, contentment with cosmetic characteristics of the device. Each item is rated on a 5 point scale from very dissatisfied to very satisfied. Scores are summed and the average of the 10 items are calculated. Higher scores indicate greater satisfaction. Scores range from 1-5.|After 4 weeks of home use (2 weeks for each socket style)|||units on a scale|||Number
682004|NCT01546675|Primary|Degrees of Shoulder Abduction Within the Prosthetic Socket|Shoulder abduction was performed to the subject’s maximum elevation. Skeletal and socket kinematics were calculated using the markerless auto-registration algorithm and X-Ray Reconstruction of Moving Morphology (XROMM)|After 4 weeks of home use (2 weeks for each socket style)|One male and one female with traumatic amputation at the transhumeral level.||degrees|||Number
682005|NCT01546649|Secondary|QT Interval Measured by 12-lead Electrocardiogram (ECG)|12-lead electrocardiography measurement was performed in supine position after 5 minutes at rest. Each measurement was recorded continuously for 10 seconds at the recording speed of 25 millimeter/second (mm/second).|Baseline, Hour 1, 3, 6 on Day 1, Day 29, 85, 169 and 337|Safety evaluation was conducted in the safety analysis set (SAS). Here ‘N’ represents evaluable baseline and post-baseline assessment population.||millisecond (msec)||Standard Deviation|Mean
682006|NCT01546649|Secondary|Serum Unchanged TAP-144 Level|This measure indicates the unchanged TAP-144 level in serum.|Baseline, Hour 1, 3, 6 on Day 1, Day 2, 3, 4, 8, 15, 22, 29, 57, 85, 113, 141, 169, 176, 183, 197, 225, 253, 281, 309 and 337|FAS included all randomized participants who had received at least a single dose of study treatment. Here ‘N’ represents evaluable baseline and post-baseline assessment population.||nanogram per deciliter (ng/dL)||Standard Deviation|Mean
682007|NCT01546649|Secondary|Distant Disease Free Survival (DDFS) Rate at Week 96|DDFS is defined as time from randomization to earliest day of onset the events, distant recurrence, secondary cancer [including breast cancer in the contralateral breast] and death. DDFS at week 96 was defined as the percentage calculated with Kaplan-Meier method, of participants did not experience any events at week 96 since the randomization.|Week 96|FAS included all randomized participants who had received at least a single dose of study treatment.||percentage of participants|||Number
682008|NCT01546649|Secondary|Disease Free Survival (DFS) Rate at Week 96|DFS is defined as time from randomization to earliest day of onset the events, recurrence [including recurrence in the ipsilateral breast], secondary cancer [including breast cancer in the contralateral breast] and death. DFS at Week 96 was defined as the percentage, calculated with Kaplan-Meier method, of participants did not experience any events at Week 96 since the randomization.|Week 96|FAS included all randomized participants who had received at least a single dose of study treatment.||percentage of participants|||Number
682009|NCT01546649|Secondary|Concentration of Follicle Stimulating Hormone (FSH)|This measure indicates serum FSH concentration at baseline and post-baseline time points.|Baseline, Hour 1, 3, 6 on Day 1, Day 2, 3, 4, 8, 15, 22, 29, 57, 85, 113, 141, 169, 176, 183, 197, 225, 253, 281, 309, 337, 421, 505, 589 and 673|FAS included all randomized participants who had received at least a single dose of study treatment. Here ‘N’ represents evaluable baseline and post-baseline assessment population.||mIU/mL||Full Range|Median
682010|NCT01546649|Secondary|Concentration of Serum Luteinizing Hormone (LH)|This measure indicates serum LH concentration at baseline and post-baseline time points. It was measured in milli-international units per milliliter (mIU/mL).|Baseline, Hour 1, 3, 6 on Day 1, Day 2, 3, 4, 8, 15, 22, 29, 57, 85, 113, 141, 169, 176, 183, 197, 225, 253, 281, 309, 337, 421, 505, 589 and 673|FAS included all randomized participants who had received at least a single dose of study treatment. Here ‘N’ represents evaluable baseline and post-baseline assessment population.||mIU/mL||Full Range|Median
682011|NCT01546649|Secondary|Concentration of Serum E2|The measure indicates serum E2 concentration at baseline and post-baseline time points.|Baseline, Hour (hr) 1, 3, 6 on Day 1, Day 2, 3, 4, 8, 15, 22, 29, 57, 85, 113, 141, 169, 176, 183, 197, 225, 253, 281, 309, 337, 421, 505, 589 and 673|FAS included all randomized participants who had received at least a single dose of study treatment. Here ‘N’ represents evaluable baseline and post-baseline assessment population.||pg/mL||Full Range|Median
682012|NCT01546649|Primary|Percentage of Participants With Suppressive Effect of Serum Estradiol (E2) to Menopausal Level (=<30 pg/mL) From Week 4 Through Week 48|Comparison of both the treatment groups was done by assessing the suppressive effect on serum E2 concentration maintained at menopausal level (=<30pg/mL). Suppression rate was calculated as proportion of participants maintained at menopausal level.|Week 4 up to Week 48|Full analysis set (FAS) included all randomized participants who had received at least a single dose of study treatment.||percentage of participants||95% Confidence Interval|Number
682013|NCT01546636|Secondary|Postanesthesia Care Unit Length of Stay (Total Time)||Approximately 5 hours|||minutes||Full Range|Median
682014|NCT01546636|Secondary|Number of Patients Experiencing Nausea and Vomiting|Assessed by recovery nurses|Postanesthesia care unit-first 2 hours|||participants|||Number
682015|NCT01546636|Primary|Incidence of Cerebral Desaturation Events|Cerebral desaturation events were measured with near-infrared spectroscopy|Intraoperative-first 2 hours|||number of events|||Number
682016|NCT01546623|Secondary|12-lead ECG||At 1 hour, week 24, and week 48 after administration|Safety evaluation was conducted in the safety analysis set (SAS), which includes all 160 patients who received the study drug [TAP-144-SR (&M) group: 81 patients, TAP-144-SR (3M) group: 79 patients||msec||Standard Deviation|Mean
682017|NCT01546623|Secondary|Serum Unchanged TAP-144 Level||From baseline to Week 48|Full analysis set participants (all randomized participants who received at least 1 dose of open-label study drug) with both Baseline and a post-baseline value; last observation carried forward was used.||ng/dL||Standard Deviation|Mean
682018|NCT01546623|Secondary|Bone Lesion Response|Partially revised assessment based on the “criteria for therapeutic effect” from the General Rule for Clinical and Pathological Studies on Prostate Canter, 4th edition. Response is measured using bone scintigraphy. Increase in new (2 or more) bone lesion is considered as progression|At Week 48|Full analysis set participants (all randomized participants who received at least 1 dose of open-label study drug) with both Baseline and a post-baseline value; last observation carried forward was used.||Percentage of participants|||Number
682019|NCT01546623|Secondary|Soft Tissue Response|Assessment in accordance with the “criteria for therapeutic effect” from the General Rule for Clinical Pathological Studies on Prostate Cancer, 4th edition. Soft tissue response was evaluated in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|At week 48|Full analysis set participants (all randomized participants who received at least 1 dose of open-label study drug) with both Baseline and a post-baseline value; last observation carried forward was used.||Percentage of participants|||Number
682020|NCT01546623|Secondary|Percentage of Participants With Progression by PSA (FAS)|Evaluation according to the “Criteria for therapeutic effect” from the General Rule for Clinical Pathological Studies on Prostate Cancer, 4th edition (determination of therapeutic effect by PSA)|From baseline to Week 48|Full analysis set participants (all randomized participants who received at least 1 dose of open-label study drug) with both Baseline and a post-baseline value; last observation carried forward was used.||percentage of participants|Participants||Number
682021|NCT01546623|Secondary|The Maximum Rate of Change in PSA Suppression (FAS)|Evaluation according to the “Criteria for therapeutic effect” from the General Rule for Clinical Pathological Studies on Prostate Cancer, 4th edition (determination of therapeutic effect by PSA)|From baseline to Week 48|Full analysis set participants (all randomized participants who received at least 1 dose of open-label study drug) with both Baseline and a post-baseline value; last observation carried forward was used.||percent change||Full Range|Median
682022|NCT01546623|Secondary|Time Course of Change Rate in Serum PSA (FAS)|Evaluation according to the “Criteria for therapeutic effect” from the General Rule for Clinical Pathological Studies on Prostate Cancer, 4th edition (determination of therapeutic effect by prostate-specific antigen [PSA])|From baseline to Week 48|Full analysis set participants (all randomized participants who received at least 1 dose of open-label study drug) with both Baseline and a post-baseline value; last observation carried forward was used.||percent change||Full Range|Median
682023|NCT01546623|Secondary|Time Course of Changes in Serum Follicle-stimulating Hormone (FSH)||From baseline to Week 48|Full analysis set participants (all randomized participants who received at least 1 dose of open-label study drug) with both Baseline and a post-baseline value; last observation carried forward was used.||mIU/mL||Full Range|Median
682024|NCT01546623|Secondary|Time Course of Changes in Serum Luteinizing Hormone (LH)||From baseline to Week 48|Full analysis set participants (all randomized participants who received at least 1 dose of open-label study drug) with both Baseline and a post-baseline value; last observation carried forward was used.||mIU/mL|Participants|Full Range|Median
682025|NCT01546623|Secondary|Time Course of Changes in Serum Testosterone||From baseline to Week 48|Full analysis set participants (all randomized participants who received at least 1 dose of open-label study drug) with both Baseline and a post-baseline value; last observation carried forward was used.||ng/dL||Full Range|Median
682026|NCT01546623|Primary|The Rate of Suppression of Serum Testosterone to Castrate Level|Comparison of the proportion of patients maintained at castration level (≤100 ng/dL)|From the start of study drug administration through Week 48|Full analysis set participants (all randomized participants who received at least 1 dose of study drug) was used.||Participants|||Number
682027|NCT01545388|Primary|Number of Participants Who Discontinued Study Drug Due to an Adverse Event||Up to 24 weeks|All participants as treated defined as all randomized participants who received at least one dose of study treatment.||Participants|||Number
682028|NCT01545388|Primary|Percentage of Participants Who Experienced at Least One Adverse Event||Up to 26 weeks|All participants as treated defined as all randomized participants who received at least one dose of study treatment.||Percentage of participants|||Number
682029|NCT01545388|Secondary|Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG)|Based on a cLDA model with terms for treatment, other prior AHA therapy status other than sitagliptin (yes/no), study drug regimen (just before meal/after meal), sitagliptin dosage (50 mg/100 mg), time and the interaction of time by treatment, time by other prior AHA therapy status, time by study drug regimen, time by sitagliptin dosage and study drug regimen by sitagliptin dosage, with a constraint that the mean baseline is the same for all treatment groups.|Baseline and Week 24|Per-protocol population defined as all randomized participants who had at least one measurement (baseline or post-randomization), with participants and/or selected data excluded due to protocol violations.||mg/dL||95% Confidence Interval|Least Squares Mean
682030|NCT01545388|Primary|Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c)|Based on a constrained longitudinal data analysis (cLDA) model with terms for treatment, other prior antihyperglycemic agent (AHA) therapy status other than sitagliptin (yes/no), study drug regimen (just before meal/after meal), sitagliptin dosage (50 mg/100 mg), time and the interaction of time by treatment, time by other prior AHA therapy status, time by study drug regimen, time by sitagliptin dosage and study drug regimen by sitagliptin dosage, with a constraint that the mean baseline is the same for all treatment groups.|Baseline and Week 24|Per-protocol population defined as all randomized participants who had at least one measurement (baseline or post-randomization), with participants and/or selected data excluded due to protocol violations.||Percent of glycosylated hemoglobin||95% Confidence Interval|Least Squares Mean
682031|NCT01545375|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs)|An SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization, as per the medical or scientific judgement of the physician. Any = Occurrence of an SAE, regardless of relationship to vaccination.|From Day 0 to Month 22|Analysis was performed on the Total vaccinated cohort which included all subjects who had received at least one vaccination dose.||Participants|||Count of Participants
682032|NCT01545375|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs) After Booster Vaccination - Immuno/Reacto Sub-cohort|An unsolicited AE was defined as any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination. The Immuno /reacto sub-cohort was composed of 200 vaccinated subjects from each study group.|Within the 31-day (Days 0-30) period post booster vaccination|Analysis was performed on Immuno/reacto sub-cohort which included around 200 subjects from the total vaccinated cohort, for whom the booster vaccination dose was documented.||Participants|||Count of Participants
682042|NCT01545375|Secondary|Concentrations of Antibodies Against Polyribosyl Ribitol Phosphate (Anti-PRP) – Immuno/Reacto Sub-cohort|Seroprotection rate = Anti-PRP antibody concentrations ≥ 0.15 µg/mL. Results at time point post booster (Month 22) were not analized at the time of posting; They will be added as soon as they are available.|One month post-dose 3 [PIII(Month 5)], prior to booster dose [PIII(Month 10)] and one month post-booster dose [Post-booster(Month 11).|Analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects from the Immuno/reacto sub-cohort (composed of 200 subjects from each study group) for whom data concerning immunogenicity outcome measures were available.||µg/mL||95% Confidence Interval|Geometric Mean
682033|NCT01545375|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs) After Primary Vaccination - Immuno/Reacto Sub-cohort|An unsolicited AE was defined as any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination. The Immuno/reacto sub-cohort was composed of 200 vaccinated subjects from each study group.|Within the 31-day (Days 0-30) period post primary vaccination, across doses|Analysis was performed on Immuno/reacto sub-cohort which included around 200 subjects from the total vaccinated cohort, for whom at least one vaccination dose was documented.||Participants|||Count of Participants
682034|NCT01545375|Secondary|Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, After Booster Vaccination – Immuno/Reacto Sub-cohort|Assessed solicited general symptoms were Drowsiness, Irritability/Fussiness (Irr./Fuss.), Loss of appetite (Loss Appet.) and Fever (axillary route - temperature equal or higher than [≥] 38.0 degrees Celsius [°C]),. Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irr./Fuss. = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = (axillary) temperature higher than (>) 40.0°C. Related = Occurrence of the specified symptom assessed by the investigator as causally related to vaccination. The Immuno /reacto sub-cohort was composed of 200 vaccinated subjects from each study group.|Within the 4-day (Days 0-3) post-booster vaccination period|Analysis was performed on Immuno/reacto sub-cohort which included around 200 subjects from the total vaccinated cohort, for whom the booster vaccination dose was documented.||Participants|||Count of Participants
682035|NCT01545375|Secondary|Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, After Primary Vaccination – Immuno/Reacto Sub-cohort|Assessed solicited general symptoms were Drowsiness, Irritability/Fussiness (Irr./Fuss.), Loss of appetite (Loss Appet.) and Fever (axillary route - temperature equal or higher than [≥] 38.0 degrees Celsius [°C]),. Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irr./Fuss. = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = (axillary) temperature higher than (>) 40.0°C. Related = Occurrence of the specified symptom assessed by the investigator as causally related to vaccination. The Immuno /reacto sub-cohort was composed of 200 vaccinated subjects from each study group.|Within the 4-day (Days 0-3) post-primary vaccination period following each dose|Analysis was performed on Immuno/reacto sub-cohort which included around 200 subjects from the total vaccinated cohort, for whom at least one vaccination dose was documented.||Participants|||Count of Participants
682036|NCT01545375|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Booster Vaccination - Immuno/Reacto Sub-cohort|Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm). The Immuno /reacto sub-cohort was composed of 200 vaccinated subjects from each study group.|Within the 4-day (Days 0-3) post-booster vaccination period|Analysis was performed on Immuno/reacto sub-cohort which included around 200 subjects from the total vaccinated cohort, for whom the booster vaccination dose was documented.||Participants|||Count of Participants
682037|NCT01545375|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Primary Vaccination - Immuno/Reacto Sub-cohort|Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm). The Immuno /reacto sub-cohort was composed of 200 vaccinated subjects from each study group.|Within the 4-day (Days 0-3) post-primary vaccination period following each dose|Analysis was performed on Immuno/reacto sub-cohort which included around 200 subjects from the total vaccinated cohort, for whom at least one vaccination dose was documented.||Participants|||Count of Participants
682038|NCT01545375|Secondary|Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 6C|Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 6C (OPA-6C). The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8.|One month post-dose 3 [PIII(Month 5)] and one month post-booster dose [Post-booster(Month 11)]||12/2018||||
682039|NCT01545375|Secondary|Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes|Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (OPA-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8.|One month post-dose 3 [PIII(Month 5)] and one month post-booster dose [Post-booster(Month 11)]||12/2018||||
682040|NCT01545375|Secondary|Antibody Concentrations Against Vaccine Serotypes 6C|No analysis was performed on antibody concentrations against vaccine serotype 6C as no specific qualified/validated assay was available.|One month post-dose 3 [PIII(Month 5)], prior to booster dose [PIII(Month 10)] and one month post-booster dose [Post-booster(Month 11)]|The analysis was to be performed on the ATP cohort for immunogenicity. But no analysis was performed for antibody concentrations against vaccine serotype 6C as no specific qualified/validated assay was available.|||||
682041|NCT01545375|Secondary|Antibody Concentrations Against Vaccine Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F|Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL.|One month post-dose 3 [PIII(Month 5)], prior to booster dose [PIII(Month 10)] and one month post-booster dose [Post-booster(Month 11)]||12/2018||||
682043|NCT01545375|Secondary|Concentrations of Antibodies Inhibiting Pneumococcal Pneumolysin Toxoid (Ply) Haemolysis Activity, or Hem-Ply Antibodies|Inhibition of Ply hemolysis activity was not evaluated due to assay stability issues.|One month post-dose 3 [PIII(Month 5)], prior to booster dose [PIII(Month 10)] and one and twelve months post-booster dose [Post-booster(Month 11) and Post-booster(Month 22)], respectively|The analysis was to be performed on the according to protocol cohort for immunogenicity. But inhibition of Ply hemolysis activity was not evaluated due to assay stability issues.|||||
682044|NCT01545375|Secondary|Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (Ply) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins – Immuno/Reacto Sub-cohort|"Anti-Ply and anti-PhtD antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA) immunoassay and expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL).
Cut-off of the assay were concentrations equal to (=) 12 EL.U/mL for anti-Ply antibodies and = 17 EL.U/mL for anti-PhtD antibodies."|One month post-dose 3 [PIII(Month 5)], prior to booster dose [PIII(Month 10)] and one and twelve months post-booster dose [Post-booster(Month 11) and Post-booster(Month 22)], respectively|Analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects from the Immuno/reacto sub-cohort (composed of 200 subjects from each study group) for whom data concerning immunogenicity outcome measures were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
682045|NCT01545375|Secondary|Number of Subjects With S. Pneumoniae (Any and Serotype Specific) in the Nasopharynx – Carriage Sub-cohort|Positive cultures of S. pneumoniae (any and serotype specific) identified in the nasopharynx were analyzed.|At 6-12 weeks of age (Month 5), 12-15 months of age (Month 10),18-22 months of age (Month 16) and 24-27 months of age (Month 22)|Analysis was performed on the Total vaccinated cohort for carriage which included around 400 subjects not included in the immuno/reacto sub-cohort, who had received at least one vaccination dose and for whom data concerning carriage outcome measures were available.||Participants|||Count of Participants
682046|NCT01545375|Secondary|Time to Occurrence of Any Medically Attended Healthcare-provider-diagnosed ALRI With Fever Documented at the Visit or History of Fever Within 3 Days Preceding a Given Episode.|"Time to occurrence of any episode of AOM is expressed in terms of rate: Person-year rate = number of episodes (n)/ sum of follow-up expressed in years (T[year)]).
A healthcare-provider-diagnosed ALRI with fever case was defined as, but not limited to, chest infection, bronchiolitis, pneumonia, bronchopneumonia, pleural effusion or empyema diagnosed by a treating physician or equivalent licensed medical professional with fever documented at the time of visit or history of fever within 3 days preceding a given episode and with or without other clinical symptoms documented in the routine medical record."|Any time from 2 weeks after the administration of dose 3 up to Month 22|Analysis was performed on the modified ATP cohort for efficacy which included all evaluable subjects for whom data concerning efficacy outcome measures were available (efficacy cohort) and for whom non-compliance with the vaccination intervals during primary vaccination was the only elimination criterion from the efficacy cohort.||Episodes per person-year|||Number
682047|NCT01545375|Secondary|Time to Occurrence of Medically Attended ALRI With Fever Documented at the Visit or History of Fever Within 3 Days Preceding a Given Episode|"Time to occurrence of any episode of AOM is expressed in terms of rate: Person-year rate = number of episodes (n)/ sum of follow-up expressed in years (T[year)]).
ALRI was defined by the presence of tachypnea (respiratory rate >50 amongst children 2 to 12 months of age, and respiratory rate >40 in children over 1 year of age) and at least two of the following signs and symptoms: cough; fever documented at visit or reported within preceding 3 days (Fever is defined as temperature ≥100.4°F (38.0°C) regardless of the route of measurement); increased work of breathing: grunting, nasal flaring, and intercostal and/or subcostal retractions; auscultatory abnormalities: wheezing, crackles, rhonchi, decreased breath sounds."|Any time from 2 weeks after the administration of dose 3 up to Month 22|Analysis was performed on the modified ATP cohort for efficacy which included all evaluable subjects for whom data concerning efficacy outcome measures were available (efficacy cohort) and for whom non-compliance with the vaccination intervals during primary vaccination was the only elimination criterion from the efficacy cohort.||Episodes per person-year|||Number
682048|NCT01545375|Secondary|Time to Occurrence of Medically Attended Acute Lower Respiratory Tract Infection (ALRI)|"Time to occurrence of any episode of AOM is expressed in terms of rate: Person-year rate = number of episodes (n)/ sum of follow-up expressed in years (T[year)]).
ALRI was defined by the presence of tachypnea (respiratory rate >50 amongst children 2 to 12 months of age, and respiratory rate >40 in children over 1 year of age) and at least two of the following signs and symptoms: cough; fever documented at visit or reported within preceding 3 days (Fever was defined as temperature ≥100.4°F (38.0°C) regardless of the route of measurement); increased work of breathing: grunting, nasal flaring, and intercostal and/or subcostal retractions; auscultatory abnormalities: wheezing, crackles, rhonchi, decreased breath sounds."|Any time from 2 weeks after the administration of dose 3 up to Month 22|Analysis was performed on the modified ATP cohort for efficacy which included all evaluable subjects for whom data concerning efficacy outcome measures were available (efficacy cohort) and for whom non-compliance with the vaccination intervals during primary vaccination was the only elimination criterion from the efficacy cohort.||Episodes per person-year|||Number
682049|NCT01545375|Secondary|Number of Subjects With Any Acute Otitis Media (AOM) With Temporally Related Carriage|AOM with temporally related carriage was defined as AOM with nasopharyngeal swab taken within 3 days before or after an AOM episode.|From the administration of dose 1 up to Month 22|Analysis was performed on the Total vaccinated cohort which included all subjects who had received at least one vaccination dose.||Participants|||Count of Participants
682050|NCT01545375|Secondary|Time to Occurrence of Any Draining Pneumococcal Acute Otitis Media (AOM)|"Time to occurrence of any episode of AOM is expressed in terms of rate: Person-year rate = number of episodes (n)/sum of follow-up expressed in years (T[year)]).
Draining AOM was defined as AOM with otorrhea or with spontaneously perforated tympanic membrane. In this case, middle ear fluid (MEF) was to be swabbed with no tympanocentesis needed and tested for the presence of S. pneumoniae and other pathogens as part of the routine clinical practice. Draining pneumococcal AOM were defined as draining AOM cases with S. pneumoniae identified in MEF."|Any time from 2 weeks after the administration of dose 3 up to Month 22|Analysis was performed on the modified ATP for efficacy which included all evaluable subjects for whom data concerning efficacy outcome measures were available (efficacy cohort) and for whom non-compliance with the vaccination intervals during primary vaccination was the only elimination criterion from the efficacy cohort.||Episodes per person-year|||Number
682051|NCT01545375|Secondary|Time to Occurrence of Any Draining Acute Otitis Media (AOM)|"Time to occurrence of any episode of AOM is expressed in terms of rate: Person-year rate = number of episodes (n)/sum of follow-up expressed in years (T[year)]).
Draining AOM was defined as AOM with otorrhea or with spontaneously perforated tympanic membrane. In this case, middle ear fluid (MEF) was to be swabbed with no tympanocentesis needed and tested for the presence of S. pneumoniae and other pathogens as part of the routine clinical practice. Draining pneumococcal AOM were defined as draining AOM cases with S. pneumoniae identified in MEF."|Any time from 2 weeks after the administration of dose 3 up to Month 22|Analysis was performed on the modified ATP for efficacy which included all evaluable subjects for whom data concerning efficacy outcome measures were available (efficacy cohort) and for whom non-compliance with the vaccination intervals during primary vaccination was the only elimination criterion from the efficacy cohort.||Episodes per person-year|||Number
682052|NCT01545375|Secondary|Number of Subjects With Any Recurrent Healthcare Provider Diagnosed Acute Otitis Media (AOM)|Recurrent AOM was defined as at least 3 AOM episodes diagnosed by a physician or equivalent licensed medical professional and occurring within 6 months or at least 4 episodes within one year, regardless of the etiology.|From the administration of dose 1 up to Month 22|Analysis was performed on the Total vaccinated cohort which included all subjects who had received at least one vaccination dose.||Participants|||Count of Participants
682053|NCT01545375|Secondary|Time to Occurrence of Any Clinical Acute Otitis Media (AOM) Diagnosed and Verified Against Modified American Academic of Pediatrics (AAP) Criteria|"Time to occurrence of any episode of AOM is expressed in terms of rate: Person-year rate = number of episodes (n)/sum of follow-up expressed in years (T[year)]).
Definition of clinical AOM diagnosed and verified against modified AAP criteria required a history of acute disease (i.e. AAP criterion 1) together with abnormal tympanic membrane (i.e. one of the AAP criteria 2 or 3a), as per the judgment of a treating physician or equivalent licensed medical professional:
1. A history of acute (recent, usually abrupt) onset of signs and symptoms of middle-ear inflammation and middle-ear effusion (MEE).AND 2. The presence of MEE that is indicated by any of the following: a) Bulging of tympanic membrane, b) Limited or absent mobility of tympanic membrane, c) Air-fluid level behind tympanic membrane, d) Otorrhea OR 3. Signs or symptoms of middle-ear inflammation as indicated by: a) Distinct erythema of tympanic membrane."|Any time from 2 weeks after the administration of dose 3 up to Month 22|Analysis was performed on the modified ATP cohort for efficacy which included all evaluable subjects for whom data concerning efficacy outcome measures were available (efficacy cohort) and for whom non-compliance with the vaccination intervals during primary vaccination was the only elimination criterion from the efficacy cohort.||Episodes per person-year|||Number
682054|NCT01545375|Secondary|Time to Occurrence of Any Episodes of AOM Diagnosed by Healthcare-provider|"Time to occurrence of any episode of AOM is expressed in terms of rate: Person-year rate = number of episodes (n)/sum of follow-up expressed in years (T[year)]).
A healthcare-provider-diagnosed clinical AOM case was defined as an AOM event diagnosed by a treating physician or equivalent licensed medical professional with or without clinical symptoms documented in the routine medical record."|Any time from 2 weeks after the administration of dose 3 up to Month 22|Analysis was performed on the modified ATP cohort for efficacy which included all evaluable subjects for whom data concerning efficacy outcome measures were available (efficacy cohort) and for whom non-compliance with the vaccination intervals during primary vaccination was the only elimination criterion from the efficacy cohort.||Episodes per person-year|||Number
682055|NCT01545375|Primary|Time to Occurrence of Any Acute Otitis Media (AOM) Diagnosed and Verified Against American Academic of Pediatrics (AAP) Criteria|"Time to occurrence of any episode of AOM is expressed in terms of rate: Person-year rate = number of episodes (n)/sum of follow-up expressed in years (T[year)]).
Definition of clinical AOM diagnosed and verified against AAP criteria required meeting three criteria based on the guidelines from the AAP [AAP, 2004], as per the judgment of a treating physician or equivalent licensed medical professional:
A history of acute (recent, usually abrupt) onset of signs and symptoms of middle-ear inflammation and middle-ear effusion (MEE).AND The presence of MEE indicated by any of the following: a) Bulging of tympanic membrane; b) Limited or absent mobility of tympanic membrane; c) Air-fluid level behind tympanic membrane; d) Otorrhea AND Signs or symptoms of middle-ear inflammation as indicated by either: a) Distinct erythema of tympanic membrane or b) Distinct otalgia (discomfort clearly referable to the ear[s] that resulted in interference with or precluded normal activity or sleep)."|Any time from 2 weeks after the administration of dose 3 up to Month 22|Analysis was performed on the modified according to protocol cohort for efficacy which included all evaluable subjects for whom data concerning efficacy outcome measures were available (efficacy cohort) and for whom non-compliance with the vaccination intervals during primary vaccination was the only elimination criterion from the efficacy cohort.||Episodes per person-year|||Number
682056|NCT01546519|Secondary|Apparent Non-renal Clearance (CLNR/F) of Vismodegib|Apparent Non-Renal Clearance (CLNR) describes the removal of vismodegib by organs other than the kidneys. This was a pre-specified PK parameter. However, due to minimal fluctuation of vismodegib concentrations at steady state, this parameter could not be determined.|Up to 8 days|PK population was the anticipated population for analysis. However, this outcome measure was not analyzed due to the minimal fluctuation of vismodegib concentrations at steady state.|||||
682057|NCT01546519|Secondary|Apparent Clearance (CL/F) of Vismodegib|CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided AUC (0-inf), expressed in liter/hour (L/hr). This was a pre-specified PK parameter. However, due to minimal fluctuation of vismodegib concentrations at steady state, this parameter could not be determined.|Up to 8 days|PK population was the anticipated population for analysis. However, this outcome measure was not analyzed due to the minimal fluctuation of vismodegib concentrations at steady state.|||||
682058|NCT01546519|Secondary|Minimum Plasma Concentration (Cmin) of Vismodegib|Cmin is defined as the minimum observed plasma concentration of Vismodegib. This was a pre-specified PK parameter. However, due to minimal fluctuation of Vismodegib concentrations at steady state, this parameter could not be determined.|Up to 8 days|PK population was the anticipated population for analysis. However, this outcome measure was not analyzed due to the minimal fluctuation of vismodegib concentrations at steady state.|||||
682302|NCT01543581|Secondary|Complete Response Rate|A secondary variable is the complete response rate, defined as the proportion of patients with no histological evidence of basal cell carcinoma on the post treatment MMS excision of the target tumor area. For this analysis, the placebo data will be pooled together to calculate the complete response rate for the placebo group.|12 to 14 weeks|||participants|||Number
682059|NCT01546519|Secondary|Time to Maximum Plasma Concentration (Tmax) of Vismodegib|Tmax is the time to reach maximum plasma concentration of vismodegib. This was a pre-specified PK parameter. However, due to minimal fluctuation of Vismodegib concentrations at steady state, this parameter could not be determined.|Up to 8 days|PK population was the anticipated population for analysis. However, this outcome measure was not analyzed due to the minimal fluctuation of vismodegib concentrations at steady state.|||||
682060|NCT01546519|Secondary|Amount of Vismodegib Excreted Into Urine in 24 Hours (Ae0-24hr)|The amount of total vismodegib excreted in urine over a 24-hr total interval (Ae0-24hr) was estimated.|24 hr total interval on Day 8|Pharmacokinetic (PK) Population: A participant was considered evaluable for the PK analyses if he or she had a full profile of vismodegib samples. Participants available at particular time point for assessment were included in the analysis.||milligrams/24 hour||Standard Deviation|Mean
682061|NCT01546519|Secondary|Renal Clearance of Vismodegib|Renal clearance (CLR) is defined as the apparent total clearance of the drug from plasma after oral administration.|0, 0.5, 1, 2, 4, 8 and 24 hours postdose on Day 8|Pharmacokinetic (PK) Population: A participant was considered evaluable for the PK analyses if he or she had a full profile of vismodegib samples. Participants available at particular time point for assessment were included in the analysis.||Liter/hour||Standard Deviation|Mean
682062|NCT01546519|Secondary|The Percentage of Dose of Vismodegib in 24-hour Total Urine|The percentage of dose vismodegib excreted in urine over a 24-hr total interval was estimated|24 hr total interval on Day 8|Pharmacokinetic (PK) Population: A participant was considered evaluable for the PK analyses if he or she had a full profile of vismodegib samples. Participants available at particular time point for assessment were included in the analysis.||% Dose Excreted in 24 hr||Standard Deviation|Mean
682063|NCT01546519|Primary|The Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUC[0-24hours]) Following Multiple Doses of Vismodegib|The steady state pharmacokinetic profile following oral administration of multiple doses of vismodegib included determining the area under the curve over the dosing interval (AUC[0-24 hours]). The AUC[0-24 hrs]) was determined by standard non-compartmental analysis using WinNonlin. Blood samples were collected at pre-dose and at 0.5, 1, 2, 4, 8 and 24 hours post-dose on Day 8 to estimate AUC(0-24 hrs).|Day 1, 2, 4 and 0, 0.5, 1, 2, 4, 8 and 24 hours postdose on Day 8|Pharmacokinetic (PK) Population: A participant was considered evaluable for the PK analyses if he or she had a full profile of vismodegib samples||Micromolar*hour||Standard Deviation|Mean
682064|NCT01546519|Primary|Maximum Observed Plasma Concentration and Concentration at Steady-state Following Multiple Doses of Vismodegib|Maximum observed plasma Concentration (Cmax) & Concentration at steady-state (Css) following multiple doses of vismodegib (150 mg QD) were analyzed. At steady state the amount of drug administered (in a given time period) is equal to the amount of drug eliminated. Blood samples for assessing Cmax and Css for analysis were collected following multiple oral doses of vismodegib at pre-dose and at 0.5, 1, 2, 4, 8 and 24 hours post-dose on Day 8. From the plasma concentration-time curve, the PK parameter Cmax and Css were determined by standard non-compartmental analysis using WinNonlin|Day 1,2,4 and 0, 0.5, 1, 2, 4, 8 and 24 hours post dose on Day 8|Pharmacokinetic (PK) Population: A participant was considered evaluable for the PK analyses if he or she had a full profile of vismodegib samples||micromolar||Standard Deviation|Mean
682065|NCT01546454|Primary|Total to HDL Cholesterol Ratio||Entire Study|||Total to HDL Cholesterol Ratio||95% Confidence Interval|Mean
682066|NCT01546402|Secondary|Change in the Visual Acuity|Change in the visual acuity as measured by the Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity scale (number of letters at 6 months - number of letters at baseline) The number of letters read on the ETDRS scale will be measured, with 0 being the worst and 35 being the best|Difference in number of letters read (6 months minus baseline)|||Number of letters on ETDRS scale||Standard Deviation|Mean
682067|NCT01546402|Primary|Change in the Central Macular Thickness|The primary outcome is the change in the central macular thickness, either an increase or decrease, as measured by optical coherence tomography as compared to the preoperative thickness.|Baseline and 6 MONTHS|||Microns||Standard Deviation|Mean
682068|NCT01546285|Primary|Difference Between the B40 Monitor and Reference Device DINAMAP PRO1000 on NIBP Measurements|The primary endpoints are the difference in systolic, diastolic and mean blood pressure values between the B40 Monitor and PRO1000. The mean of the difference should be no more than 5mmHg and the standard deviation of the difference should be no more than 8mmHg per the AAMI SP-10 standard.|End of each blood pressure reading|66 subjects were enrolled. 64 subjects contributed data to the study. Subject 058 had a lateral difference of the reference diastolic blood pressure more than 10mmHg, and NIBP data was excluded from final analysis as specified in AAMI SP-10 standard. And Subject 046 had circulation issues and no data was collected.||mmHg||Standard Deviation|Mean
682069|NCT01546207|Secondary|Signal-Average ECG|Relationship between change in pre/post saECG and success of the step-wise ablation strategy|baseline and post-op day one after procedure||||||
682070|NCT01546207|Secondary|Procedural Safety|2) Procedural safety as defined by the number of complication within 1week associated with the procedure.|1 week post-op||||||
682071|NCT01546207|Secondary|ICD Interrogation|Chronic success will be defined as no recurrence of sustained VT or VT resulting in ICD therapies (ATP and/or ICD shocks) at 6 months follow-up as compared to baseline.|baseline and 6 months follow-up||||||
682072|NCT01546207|Primary|Catheter Ablation|The procedural efficacy as defined as acute success of a standardized step-wise approach for substrate-based catheter ablation of recurrent ventricular tachycardia in patients with coronary artery disease and prior ventricular tachycardia or appropriate therapy. Acute success will be defined as the ability to render VT non-inducible with a standardized complete stimulation protocol. catheter ablation - a medical procedure used to treat some types of arrhythmia|at time of catheter ablation procedure (intraoperative)||||||
682073|NCT01546194|Primary|Overall Patient Satisfaction With the Same-day Consent Process-total Number of Questions Answered With a Score of 0 to 10 (on a 11-point Scale From 0=Strongly Disagree to 10=Strongly Agree).|Subjects will reply using a 11-point scale from 0=strongly disagree to 10=strongly agree.|First postoperative day|||units on a scale||Full Range|Median
682074|NCT01546155|Primary|PET/MRI Brain Activation|"Simultaneously collect fMRI-PET data in humans to investigate the change between bold signal evoked by pressure pain and bold signal evoked by non-painful pressure.
The PET analyses generates one value per 120 minutes. This value is compared to the other 120 minute scan PET value in order to reflect the change."|day one|||percentage BOLD signal change||Standard Deviation|Mean
682075|NCT01546142|Secondary|Change From Baseline in Patient-Reported Submental Fat Impact Scale (PR-SMFIS)|The PR-SMFIS assesses the impact of submental fat on self-perception of 6 emotional and visual characteristics related to the appearance of submental fullness (unhappy, bothered, self-conscious, embarrassed, look older, and look overweight) as evaluated by the participant. Each item is rated on an 11-point numeric scale from 0 to 10. Scores for the 6 items were averaged to generate a PR-SMFIS total scale score ranging from 0 to 10 where 0 is a positive outcome and 10 is a negative outcome. A negative change from Baseline indicates improvement.|Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)|Intent-to-treat population; missing values were imputed using a multiple imputation process.||units on a scale||Standard Deviation|Mean
682076|NCT01546142|Secondary|Percentage of Participants With a Magnetic Resonance Imaging (MRI) Response|An MRI responder is a participant who exhibited at least a 10% reduction in submental fat volume as measured by MRI from Baseline to 12 weeks after last treatment. Magnetic resonance imaging was evaluated in a subset of participants at selected centers.|Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)|The ITT-MRI population consisted of all randomized participants who participated in the MRI cohort and had evaluable Baseline MRI data. A multiple imputation process was used.||percentage of participants|||Number
682077|NCT01546142|Primary|Percentage of Participants Who Achieved a Composite 2-grade Response|"A composite 2-grade response is defined as at least a 2-grade improvement from Baseline on both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) 12 weeks after the last treatment.
The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.
The PR-SMFRS is based on the participant's response to the question How much fat do you have under your chin right now? answered on a 5-point ordinal scale (0-4) with 0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat."|Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)|Intent-to-treat population; missing values were imputed using a multiple imputation process.||percentage of participants|||Number
682078|NCT01546142|Primary|Percentage of Participants Who Achieved a Composite 1-grade Response|"A composite 1-grade response is defined as at least a 1-grade improvement from Baseline on both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) 12 weeks after the last treatment.
The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.
The PR-SMFRS is based on the participant's response to the question How much fat do you have under your chin right now? answered on a 5-point ordinal scale (0-4) with 0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat."|Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)|Intent-to-treat (ITT) population; missing values were imputed using a multiple imputation process.||percentage of participants|||Number
682079|NCT01545843|Secondary|Change in Neuropsychological Functioning|Change in multiple domains of neuropsychological functioning (e.g., memory, attention, executive functioning)|Baseline, 2 weeks, 8 weeks||||||
682080|NCT01545843|Secondary|Change in EEG Sleep Measures|Measurement of EEG activity during sleep using polysomnography|Baseline, 2 weeks, 8 weeks||||||
682081|NCT01545843|Secondary|Pittsburgh Sleep Quality Index|Self-report measure of sleep quality|Posttreatment (8 weeks)||||||
682082|NCT01545843|Secondary|Quick Inventory of Depressive Symptoms (QIDS)|Patient-reported depression symptom severity at post-treatment, total score. Total scores range from 0 to 27. Higher scores represent more severe depression.|Post-treatment (8 weeks)|||units on a scale||Standard Deviation|Mean
682083|NCT01545843|Primary|Hamilton Rating Scale for Depression-17 Item Minus Sleep Items|Total score on a clinician-rated measure of depressive symptoms, minus 3 sleep items Total score range: 0-46. Higher scores represent more severe depression.|Post-treatment (8 weeks)|||units on a scale||Standard Deviation|Mean
682084|NCT01545765|Primary|Duration of Anesthesia(Minutes)|Onset and end of anesthesia are evaluated by Pinprick tests. Duration of anesthesia is calculated as: difference between onset and end of anesthesia (minutes).|From T0 (product removal) up to T8 hours after product removal|A standard sample size for this type of study is 30 subjects. The analyses are performed on the safety population (APT), corresponding to the enrolled and randomized population, after exclusion of subjects who never applied the treatments with certainty. Missing data were to be treated as missing for all analyses.||Minutes||Full Range|Median
682085|NCT01545765|Secondary|Adverse Events|Incidence of adverse events was to be reported during the study period|During the study|A standard sample size for this type of study is 30 subjects. The analyses are performed on the safety population (APT), corresponding to the enrolled and randomized population, after exclusion of subjects who never applied the treatments with certainty. Missing data were to be treated as missing for all analyses.||participants|||Number
682086|NCT01545700|Primary|Serum Blood Glucose Concentrations|Serum blood glucose concentrations|Patient were followed for the duration of hospitalization, for an average of 6 days|per protocol||mg/dl||Standard Deviation|Mean
682087|NCT01545700|Secondary|Pain Scores|VAS pain scoes at rest 0=no pain, 100=worst pain imaginable|Patients were followed for the duration of hospitalization, for an average of 6 days|||0-100 VAS scale scores on a scale||Standard Deviation|Mean
682088|NCT01545518|Primary|Immune Abnormalities|neuronal nuclear, cytoplasmic, and cell surface autoantibodies|Screening visit|No analysis occurred and study was terminated early due to subject numbers not eligible for the 2nd phase of the study.|||||
682089|NCT01545336|Secondary|Six Minute Walk Distance||Baseline, 3 months|||% change from baseline||Inter-Quartile Range|Median
682090|NCT01545336|Primary|Tricuspid Annular Plane Systolic Excursion (TAPSE)||Baseline, 3 months|||% change from baseline||Inter-Quartile Range|Median
682091|NCT01545336|Primary|Plasma Estradiol (E2) Level||Baseline, 3 months|||% change from baseline||Inter-Quartile Range|Median
682092|NCT01545232|Secondary|Amount of Blood Products Given From Hemostasis to 24 Hours After ED Admission||24 hours after ED admission|Unit of measure for outcome measures below is median number of blood product units that given in each group (1:1:1 or 1:1:2) from time initial hemostasis was complete (PROPPR randomized study products stopped) up to 24 hours following ED admission. Number of participants is based on those who survived up to 24 hours, not participants randomized.||units of blood products||Inter-Quartile Range|Median
682093|NCT01545232|Secondary|ICU Free Days||first 30 days after ED admission|Number of ICU free days for each group.||days||Inter-Quartile Range|Median
682094|NCT01545232|Secondary|Ventilator Free Days||first 30 days after ED admission|Number of ventilator free days for each group.||days||Inter-Quartile Range|Median
682095|NCT01545232|Secondary|Initial Hospital Discharge Status||Hospital discharge or 30 days, whichever comes first|Disposition of subject at time of hospital discharge||participants|||Number
682096|NCT01545232|Secondary|Incidence of Transfusion Related Serious Adverse Events||ED admission to hospital discharge or 30 days, whichever comes first|Incidence of transfusion related serious adverse events-Reportable to FDA||participants|||Number
682097|NCT01545232|Secondary|Incidence of Primary Surgical Procedure||ED admission to hospital discharge or 30 days, whichever comes first|Incidence of primary surgical procedure||participants|||Number
682098|NCT01545232|Secondary|Functional Status at Time of Hospital Discharge|The Glasgow Outcome Extended Score (GOSE) is a tool used to measure recovery following brain injury and assists with prediction of long-term rehabilitation. The 8 scoring categories are death, vegetative state, lower severe disability, upper severe disability, lower moderate disability, upper moderate disability, lower good recovery and upper good recovery. A higher GOSE score correlates with better outcome.|Hospital discharge or 30 days, whichever comes first|Glasgow Outcome Extended Score (GOSE) Score on discharged patients who had a head injury (Abbreviated Injury Score (AIS) > 1) ranging from 1 to 8. The AIS is a coding scale to classify the injury severity. A score is created for each body region, type of anatomic structure (i.e. whole area, vessels,organs), and severity(minor to maximum).||units on the GOSE scale||Inter-Quartile Range|Median
682099|NCT01545232|Secondary|Amount of Randomized Blood Products Given to Hemostasis||24 hours from randomization|||units of blood products||Inter-Quartile Range|Median
682100|NCT01545232|Secondary|Time to Hemostasis|Time to hemostasis refers to the time that the subject achieved hemorrhage control (anatomic hemostasis and resuscitation complete)following emergency department (ED) arrival.|ED admission to hospital discharge or 30 days, whichever comes first|Time to anatomic hemostasis||minutes||Inter-Quartile Range|Median
682101|NCT01545232|Secondary|Hospital Free Days||first 30 days after ED admission|Number of hospital free days for each group.||days||Inter-Quartile Range|Median
682102|NCT01545232|Primary|Coagulation and Inflammatory Phenotypes at Emergency Department Admission and Over Time.||72 hours||||||
682103|NCT01545232|Primary|30-day Mortality||First 30 days after ED admission|Number of subjects enrolled into each group.||participants|||Number
682104|NCT01545232|Primary|24-hour Mortality||First 24 hours after ED admission|Number of subjects who were randomized to each group||participants|||Number
682105|NCT01545193|Secondary|PACU Length of Stay|The time required to meet discharge criteria and achieve actual discharge will be noted.|Early postoperative period, up to 24 hours|||minutes||Inter-Quartile Range|Median
682106|NCT01545193|Secondary|Respiratory Events Potentially Related to Residual Neuromuscular Blockade|Pulse oximetry will be used to continuously monitor arterial oxygen saturations (Sp02) during patient transport and in the PACU. Data reported are the number of patients developing hypoxemia (oxygen saturation < 94% on pulse oximetry) in the PACU|Early postoperative period, up to 24 hours|||participants|||Number
682107|NCT01545193|Secondary|Signs and Symptoms of Residual Neuromuscular Blockade|A standardized examination form will be used to determine the presence or absence of muscle weakness in a variety of muscle groups. The examination will be performed on arrival to the PACU and again 15 minutes after admission. Reported data is the total number of symptoms (0-16) at PACU admission|Early postoperative period, up to 24 hours|||symptoms||Inter-Quartile Range|Median
682108|NCT01545193|Primary|Incidence of Residual Neuromuscular Blockade|The TOF-Watch SX will be used to determine the incidence of residual neuromuscular blockade. The TOF-Watch SX consists of a nerve stimulator and a sensor to quantify the TOF ratio. Two consecutive responses to train-of-four (TOF) stimulation will be obtained, and the average of the two values recorded. If the measurements differ by greater than 10%, additional TOF ratios can be obtained (up to a total of 4 TOF values), and the closest two ratios averaged. The number of patients with TOF ratios < 0.9 in each group will be compared.|Early postoperative period, up to 24 hours|||participants|||Number
682109|NCT01544998|Primary|Change in Natriuresis (Urinary Sodium Excretion) at 60 Minutes for Preclinical Diastolic Dysfunction (PDD) Reporting Group|Value at 60 minutes minus value at baseline.|Baseline, 60 minutes after saline load|This was a within PDD reporting group comparison; between PSD and PDD groups were not compared.||mEq/min||Standard Deviation|Mean
682110|NCT01544998|Secondary|Change in Urinary Cyclic Guanosine Monophosphate (cGMP) at 60 Minutes||Baseline, 60 minutes after saline load||05/2017||||
682111|NCT01544998|Secondary|Change in Glomerular Filtration Rate (GFR) at 60 Minutes||Baseline, 60 minutes after saline load||05/2017||||
682112|NCT01544998|Primary|Change in Natriuresis (Urinary Sodium Excretion) at 60 Minutes for Preclinical Systolic Dysfunction (PSD) Reporting Group|Value at 60 minutes minus value at baseline.|Baseline, 60 minutes after saline load|This was a within PSD reporting group comparison; between PSD and PDD groups were not compared.||mEq/min||Standard Deviation|Mean
682113|NCT01544920|Secondary|Percentage of Participants Who Had Undetectable HCV RNA at Week 4 Achieving SVR24|SVR24 rates were determined for only participants that had undetectable HCV RNA at Week 4 of treatment (Arm 1a and Arm 2a). HCV RNA viral load was determined using the Roche COBAS® AmpliPrep/COBAS® TaqMan HCV Test v1.0, which has a lower limit of quantification of 43 IU/mL.|Up to Week 48|The Full Analysis Set (FAS) consisted of all participants who completed the 4-week peg-IFN + RBV lead-in, who were randomized at Week 4, and also had undetectable HCV RNA at Week 4.||Percentage of participants|||Number
682114|NCT01544920|Primary|Percentage of Participants With Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) 24 Weeks After Completing Study Treatment (SVR24)|SVR24 rates were determined for all participants in Arm 1 and Arm 2. HCV RNA viral load was determined using the Roche COBAS® AmpliPrep/COBAS® TaqMan HCV Test v1.0, which has a lower limit of quantification of 43 IU/mL.|Up to Week 74|The Full Analysis Set (FAS) consisted of all participants who completed the 4-week peg-IFN + RBV lead-in and who were randomized at Week 4.||Percentage of participants|||Number
682115|NCT01544582|Secondary|Incidence of Anemia, Grade 3/4 Neutropenia, Grade 3/4 Thrombocytopenia, and Serious Skin Rash|The incidence (events per 1000 participant-days) of the protocol-defined HOIs (anemia, grade 3/4 neutropenia, grade 3/4 thrombocytopenia, and serious skin rash) was calculated over the 48-week period following the start of CHC treatment exposure. All protocol-defined HOIs were taken into account (serious and non-serious HOIs). For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment groups were not mutually exclusive). The incidence per 1000 participant-days of anemia, grade 3/4 neutropenia, grade 3/4 thrombocytopenia, and serious skin rash were reported by CHC treatment group of exposure with 95% confidence intervals.|Up to 48 weeks of treatment|Participants in Analysis Population (CHC genotype-1 participants meeting eligibility criteria and treated with boceprevir+PR, telaprevir+PR, or PR alone) with available data who did not already experience HOI during 3 months preceding CHC treatment regimen. Participants categorized by treatment group of exposure further described in Arm Description||events per 1000 participant-days||95% Confidence Interval|Number
682116|NCT01544582|Primary|Percentage of Serious Rash Episodes Managed by Each Clinical Intervention Out of All Managed Episodes|"Clinical interventions used to manage episodes of serious rash in participants could include topical corticosteroid (TC), intravenous (IV) and/or oral (PO) corticosteroids (IV/PO CS), emollients/moisturizers (E/M), antihistamines (AH), other treatment (OT), and CHC treatment regimen modifications including drug dose reduction (DDR), drug discontinuation (DD), and drug interruption (DI). For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment groups were not mutually exclusive).
For each CHC treatment exposure group, the percentage of serious rash episodes managed by a particular intervention are reported out of the total number of managed serious rash episodes with data available for that intervention (i.e. serious rash episodes with missing data for an intervention were excluded)."|Up to 48 weeks of a treatment regimen|Participants in the Analysis Population (all CHC genotype-1 participants included on study meeting eligibility criteria and treated with boceprevir plus PR, telaprevir plus PR, or PR alone) who experienced at least one episode of serious rash. Participants categorized by treatment group of exposure (further described in Arm Description).||percentage of episodes|Participants||Number
682117|NCT01544582|Primary|Percentage of Serious Rash Episodes Managed by at Least One Clinical Intervention|Serious rash was considered a HOI for this study and included rash > 50% of body surface area, rash associated with significant systemic symptoms, or rash resulting in hospitalization or urgent care visit. Clinical interventions used to manage episodes of serious rash in participants could include topical corticosteroid use, intravenous (IV) and/or oral corticosteroids, emollients/moisturizers, antihistamines, other treatment, and CHC treatment regimen modifications (drug dose reduction, drug discontinuation, and drug interruption). For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment groups were not mutually exclusive). The percentage of serious rash episodes that were managed by at least one intervention is reported for each CHC treatment exposure group with 95% confidence intervals.|Up to 48 weeks of a treatment regimen|Participants in the Analysis Population (all CHC genotype-1 participants included on study meeting eligibility criteria and treated with boceprevir plus PR, telaprevir plus PR, or PR alone) who experienced at least one episode of serious rash. Participants categorized by treatment group of exposure (further described in Arm Description).||percentage of episodes|Participants|95% Confidence Interval|Number
682118|NCT01544582|Primary|Percentage of Grade 3/4 Thrombocytopenia Episodes Managed by Each Clinical Intervention Out of All Managed Episodes|"Clinical interventions used to manage episodes of grade 3/4 thrombocytopenia in participants could include thrombopoietin (TPO), platelet transfusion (PT), other treatment (OT) , and CHC treatment regimen modifications including drug dose reduction (DDR), drug discontinuation (DD), and drug interruption (DI). For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment groups were not mutually exclusive).
For each CHC treatment exposure group, the percentage of grade 3/4 thrombocytopenia episodes managed by a particular intervention are reported out of the total number of managed grade 3/4 thrombocytopenia episodes with data available for that intervention (i.e. grade 3/4 thrombocytopenia episodes with missing data for an intervention were excluded)."|Up to 48 weeks of a treatment regimen|Participants in Analysis Population (all CHC genotype-1 participants included on study meeting eligibility criteria and treated with boceprevir plus PR, telaprevir plus PR, or PR alone) who experienced at least one episode of grade 3/4 thrombocytopenia. Participants categorized by treatment group of exposure (further described in Arm Description).||percentage of episodes|Participants||Number
682119|NCT01544582|Primary|Percentage of Grade 3/4 Thrombocytopenia Episodes Managed by at Least One Clinical Intervention|Grade 3/4 thrombocytopenia (Grade 3: platelet count 25 - <50 × 10^9/L, Grade 4: <25 × 10^9/L) was considered a HOI for this study. Clinical interventions used to manage episodes of grade 3/4 thrombocytopenia in participants could include thrombopoietin, platelet transfusion, other treatment, and CHC treatment regimen modifications (drug dose reduction, drug discontinuation, and drug interruption). For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment groups were not mutually exclusive). The percentage of grade 3/4 thrombocytopenia episodes that were managed by at least one intervention is reported for each CHC treatment exposure group with 95% confidence intervals.|Up to 48 weeks of a treatment regimen|Participants in Analysis Population (all CHC genotype-1 participants included on study meeting eligibility criteria and treated with boceprevir plus PR, telaprevir plus PR, or PR alone) who experienced at least one episode of grade 3/4 thrombocytopenia. Participants categorized by treatment group of exposure (further described in Arm Description).||percentage of episodes|Participants|95% Confidence Interval|Number
682120|NCT01544582|Primary|Percentage of Grade 3/4 Neutropenia Episodes Managed by Each Clinical Intervention Out of All Managed Episodes|"Clinical interventions used to manage episodes of grade 3/4 neutropenia in participants could include Granulocyte colony-stimulating factor (G-CSF) use, other treatment (OT), and CHC treatment regimen modifications including drug dose reduction (DDR), drug discontinuation (DD), and drug interruption (DI). More than one treatment modification could have been performed. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment groups were not mutually exclusive).
For each CHC treatment exposure group, the percentage of grade 3/4 neutropenia episodes managed by a particular intervention are reported out of the total number of managed grade 3/4 neutropenia episodes with data available for that intervention (i.e. grade 3/4 neutropenia episodes with missing data for an intervention were excluded)."|Up to 48 weeks of a treatment regimen|Participants in the Analysis Population (all CHC genotype-1 participants included on study meeting eligibility criteria and treated with boceprevir plus PR, telaprevir plus PR, or PR alone) who experienced at least one episode of grade 3/4 neutropenia. Participants categorized by treatment group of exposure (further described in Arm Description).||percentage of episodes|Participants||Number
682121|NCT01544582|Primary|Percentage of Grade 3/4 Neutropenia Episodes Managed by at Least One Clinical Intervention|Grade 3/4 neutropenia (Grade 3: neutrophil count 0.5 - <0.75 × 10^9/L, Grade 4: <0.5 × 10^9/L) was considered a HOI for this study. Clinical interventions used to manage episodes of grade 3/4 neutropenia in participants could include Granulocyte colony-stimulating factor (G-CSF) use and CHC treatment regimen modifications (drug dose reduction, drug discontinuation, and drug interruption). For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment groups were not mutually exclusive). The percentage of grade 3/4 neutropenia episodes that were managed by at least one intervention is reported for each CHC treatment exposure group with 95% confidence intervals.|Up to 48 weeks of a treatment regimen|Participants in the Analysis Population (all CHC genotype-1 participants included on study meeting eligibility criteria and treated with boceprevir plus PR, telaprevir plus PR, or PR alone) who experienced at least one episode of grade 3/4 neutropenia. Participants categorized by treatment group of exposure (further described in Arm Description).||percentage of episodes|Participants|95% Confidence Interval|Number
682122|NCT01544582|Primary|Percentage of Anemia Episodes Managed by Each Clinical Intervention Out of All Managed Anemia Episodes|"Clinical interventions used to manage episodes of anemia in participants could include erythropoiesis stimulating agent (ESA), blood transfusion (BT), other treatment (OT), and CHC treatment regimen modifications including drug dose reduction (DDR), drug discontinuation (DD), and drug interruption (DI). Interventions could be used in combination (e.g. ESA plus blood transfusion) and more than one treatment modification could have been performed. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment groups were not mutually exclusive).
For each CHC treatment exposure group, the percentage of anemia episodes managed by a particular intervention are reported out of the total number of managed anemia episodes with data available for that intervention (i.e. anemia episodes with missing data for an intervention were excluded)."|Up to 48 weeks of a treatment regimen|Participants in the Analysis Population (all CHC genotype-1 participants included on study meeting eligibility criteria and treated with boceprevir plus PR, telaprevir plus PR, or PR alone) who experienced at least one episode of anemia. Participants categorized by treatment group of exposure (further described in Arm Description).||percentage of episodes|Participants||Number
682123|NCT01544582|Primary|Percentage of Anemia Episodes Managed by at Least One Clinical Intervention|Anemia (hemoglobin <10 g/dL) was considered a Health Outcome of Interest (HOI) for this study. Clinical interventions used to manage episodes of anemia in participants could include erythropoiesis stimulating agent (ESA), blood transfusion, drug dose reduction, other treatment, and CHC treatment regimen modifications (drug dose reduction, drug discontinuation, and drug interruption). For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment groups were not mutually exclusive). The percentage of anemia episodes that were managed by at least one intervention is reported for each CHC treatment exposure group with 95% confidence intervals.|Up to 48 weeks of a treatment regimen|Participants in the Analysis Population (all CHC genotype-1 participants included on study meeting eligibility criteria and treated with boceprevir plus PR, telaprevir plus PR, or PR alone) who experienced at least one episode of anemia. Participants categorized by treatment group of exposure (further described in Arm Description).||percentage of episodes|Participants|95% Confidence Interval|Number
682124|NCT01544582|Primary|Baseline Disease Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Baseline Grade for Child-Pugh Score|The Child-Pugh Score is used to determine the prognosis of chronic liver disease, in particular cirrhosis. It is classified into Classes A (best prognosis) to C (worst prognosis). Child-Pugh scores assessed within 3 months before CHC treatment regimen initiation were recorded from the eCRF, and the number of participants who were Grade A, Grade B, Grade C, not assessed, or unknown whether assessed were reported.|Before initiation of CHC treatment (Week 0 baseline)|Participants in the Analysis Population (all CHC genotype-1 participants included in study meeting eligibility criteria and receiving boceprevir plus peginterferon and ribavirin (PR), telaprevir plus PR, or PR alone) with available demographic data (Child Pugh score).||participants|||Number
682125|NCT01544582|Primary|Baseline Disease Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Baseline Viral Load|Participant baseline HCV viral load was recorded from the eCRF and categorized as either “Low” (<800,000 IU/mL or <2,000,000 RNA copies/mL) or “High” (≥800,000 IU/mL or ≥2,000,000 RNA copies/mL).|Before initiation of CHC treatment (Week 0 baseline)|Participants in the Analysis Population (all CHC genotype-1 participants included in study meeting eligibility criteria and receiving boceprevir plus peginterferon and ribavirin (PR), telaprevir plus PR, or PR alone) with available demographic data (viral load).||participants|||Number
682460|NCT01541826|Secondary|Intercellular Adhesion Molecule 1|Fasting plasma intercellular adhesion molecule 1 after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 6 weeks, 12 weeks|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.||ng/mL||Standard Error|Mean
682126|NCT01544582|Primary|Baseline Disease Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Baseline Hepatitis C Virus (HCV) Genotype|Baseline HCV genotype was recorded from the eCRF and the number of participants who were 1a genotype, 1b genotype, or unknown/other was reported.|Before initiation of CHC treatment (Week 0 baseline)|Participants in the Analysis Population (all CHC genotype-1 participants included in study meeting eligibility criteria and receiving boceprevir plus peginterferon and ribavirin (PR), telaprevir plus PR, or PR alone) with available demographic data (HCV genotype).||participants|||Number
682127|NCT01544582|Primary|Baseline Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Body Mass Index (BMI)|Baseline mean body mass index (SD) in Kg/m^2 was recorded from the eCRF.|Before initiation of CHC treatment (Week 0 baseline)|Participants in the Analysis Population (all CHC genotype-1 participants included in study meeting eligibility criteria and receiving boceprevir plus peginterferon and ribavirin (PR), telaprevir plus PR, or PR alone) with available demographic data (BMI).||Kg/m^2||Standard Deviation|Mean
682128|NCT01544582|Primary|Baseline Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Height|Baseline mean height (SD) in centimeters (cm) was recorded from the eCRF.|Before initiation of CHC treatment (Week 0 baseline)|Participants in the Analysis Population (all CHC genotype-1 participants included in study meeting eligibility criteria and receiving boceprevir plus peginterferon and ribavirin (PR), telaprevir plus PR, or PR alone) with available demographic data (height).||centimeters||Standard Deviation|Mean
682129|NCT01544582|Primary|Baseline Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Weight|Baseline mean weight (standard deviation [SD]) in kilograms (Kg) was recorded from the eCRF.|Before initiation of CHC treatment (Week 0 baseline)|Participants in the Analysis Population (all CHC genotype-1 participants included in study meeting eligibility criteria and receiving boceprevir plus peginterferon and ribavirin (PR), telaprevir plus PR, or PR alone) with available demographic data (weight).||kilograms (Kg)||Standard Deviation|Mean
682130|NCT01544582|Primary|Percentage of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone (Drug Utilization Pattern)|The percentage of CHC participants initiating boceprevir plus PR treatment, telaprevir plus PR treatment, or PR treatment alone was determined from a Drug Utilization questionnaire that was administered to physicians using an electronic Case Report Form (eCRF) to collect site level information and reported with 95% confidence intervals.|Up to 37 months|Analysis Population: All CHC genotype-1 participants included in study meeting eligibility criteria and receiving boceprevir plus peginterferon and ribavirin (PR), telaprevir plus PR, or PR alone.||percentage of participants||95% Confidence Interval|Number
682131|NCT01544478|Primary|Combined Incidence of Cervical Intraepithelial Neoplasia (CIN) 2/3 or Worse Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18|The endpoint included pathology panel consensus diagnosis of CIN 2 or 3, adenocarcinoma in situ, invasive squamous cervical carcinoma, or invasive adenocarcinoma of the cervix, and HPV type 6, 11, 16, or 18 detected in an adjacent section from the same tissue block. The point estimates and exact 95% confidence intervals for incidence rate were based on the Poisson distribution.|Up to Month 48|The population analyzed included participants who received the full vaccination series, had at least 1 visit after Month 7, had no general protocol violations, and were seronegative at Baseline and polymerase chain reaction-negative from Baseline through Month 7 for the relevant HPV type.||Cases per 100 person-years at risk|Person-years at risk|95% Confidence Interval|Number
682132|NCT01544361|Secondary|Number of Participants With Anti-Drug Antibodies (ADAs) for MEDI7814||Day 1, 29, 57, 85, and 106|Analyses of immunogenicity was not performed as the clinical development of MEDI7814 had been discontinued because the indication was no longer being pursued.|||||
682133|NCT01544361|Secondary|Pharmacokinetic (PK) Parameters of MEDI7814|Individual MEDI7814 plasma concentration data and descriptive statistics of the PK parameters were to be tabulated by treatment group. Non-compartmental PK data analysis were to be performed for MEDI7814-treated participants to estimate PK parameters if data allowed.|Predose, end of infusion, 2, 6, 12 hours post-end of infusion on Day 1; Day 2, 3, 5, 8, 15, 22, 29, 43, 57, 85, and 106|Analyses of PK was not performed as the clinical development of MEDI7814 had been discontinued because the indication was no longer being pursued.|||||
682134|NCT01544361|Primary|Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study drug and up to Day 106 that were absent before treatment or that worsened relative to pretreatment state. AEs included SAEs as well as non-serious AEs which occurred during the trial.|Day 1 to Day 106|Safety population included all randomized participants who received MEDI7814 and had safety data available.||Participants|||Number
682135|NCT01544348|Secondary|Free Immunoglobulin E (IgE) Serum Concentration||Day -28 (Screening), -1, 1 (pre-dose), 2, 3, 5, 8, 15, 22, 29, 43, 57, and 85 for all groups; 2 hours post-dose on Day 1 for MEDI4212 300 mg Intravenous group only|Safety population included all participants who received any amount of investigational product and had safety data available. 'n' signifies those participants who evaluable for this outcome measure at specified time point for each group, respectively.||ng/mL||Standard Deviation|Mean
682136|NCT01544348|Secondary|Number of Participants Exhibiting Anti-Drug Antibodies for MEDI4212 at Any Visit|Anti-drug antibodies for MEDI4212 were analyzed for participants who received placebo or MEDI4212 as per planned analysis.|Days 1 (pre-dose), 15, 43, and 85|Immunogenicity population included all participants who received any investigational product and had at least one valid immunogenicity test result.||participants|||Number
682153|NCT01544309|Secondary|Occurrence of Deterioration of Diabetic Treatment Status|“Deterioration of diabetic treatment status” is defined as addition of new drug, increase in dosage, drug changes (therapy intensification), and deterioration in HbA1c of > 0.5%.|Baseline, 12 months after administration|Full analysis set - All participants who received at least 1 dose of open-label study drug except the ones who had no HbA1c or non-HDL-C data or a protocol deviation of the administration of study drugs.||Participants|||Number
682137|NCT01544348|Secondary|Observed Serum Concentration|Serum concentration of omalizumab and MEDI4212 were measured for participants who received omalizumab and MEDI4212, respectively.|Pre-dose and post-dose on Day 1; Day 2, 3, 5, 8, 15, 22, 29, 43, 57 and 85|Pharmacokinetic (PK) population included all participants who received any investigational product and had a sufficient number of serum concentration measurements for computing PK parameters. Here 'n' signifies participants evaluable for this outcome measure at specified time point, for each group respectively||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
682138|NCT01544348|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study drug and up to Day 85 that were absent before treatment or that worsened relative to pre-treatment state.|Day 1 to 85|Safety population included all participants who received any amount of investigational product and had safety data available.||participants|||Number
682139|NCT01544309|Secondary|Change From Baseline in 1,5-AG Level|An inverse relationship exists between mean change in 1,5-AG level and the mean rate of change when the degree of standard deviation is large, wherein the mean change is negative although the mean rate of change is positive or vice versa|Baseline, 3, 6, 12 months after administration and the end of study treatment（or at the occurrence of deterioration of diabetic treatment status）|||μg/mL||Standard Deviation|Mean
682140|NCT01544309|Secondary|Rate of Patients Who Have Reached the Target LDL-C Level Specified in Japan Atherosclerosis Society Guidelines (JASGL) 2007|Percentage of participants achieving the target LDL-C levels <100 mg/dL for participants with history of coronary artery diseases (CAD) and <120 mg/dL for participants without history of CAD are presented.|3 months after administration, the end of starting dose and the end of study treatment|Full analysis set except participants who have reached the target LDL-C level specified at the treatment start||Percentage of participants||95% Confidence Interval|Number
682141|NCT01544309|Secondary|Percent Changes in Lipids and Inflammatory Marker (Hs-CRP) and Their Correlation|Correlation between percent changes in lipids (LDL-C, HDL-C, non-HDL-C, TG, non-HDL-C/HDL-C ratio, LDL-C/HDL-C ratio, TC and FFA) and inflammatory marker (hs-CRP)|Baseline, 3, 6, 12 months after administration, the end of starting dose and the end of study treatment||||||
682142|NCT01544309|Secondary|Percent Change in Non-HDL-C Level||Baseline, 3 and 6 months after administration, the end of starting dose and the end of study treatment|Participants in FAS except the ones who had no non-HDL-C level data at 12 months.||Percent change||Standard Deviation|Mean
682143|NCT01544309|Secondary|Percent Changes in Lipids (LDL-C, HDL-C, TC, TG, Non-HDL-C/HDL-C Ratio, and FFA)||Baseline, 3, 6, 12 months after administration, the end of starting dose and the end of study treatment|Participants in FAS except the ones who had no lipids level data at 12 months.||Percent change||Standard Deviation|Mean
682144|NCT01544309|Secondary|Frequency of Serious Adverse Events (SAE)||Up to 12 months|||Number of patients with SAE|||Number
682145|NCT01544309|Secondary|Frequency of Cardiovascular Events (Coronary Artery Disease, Heart Failure, Cerebrovascular Disease, Peripheral Artery Disease and Aortic Disease)||From the start of the treatment to the end of study treatment|||Number of patients with any events|||Number
682146|NCT01544309|Secondary|Change From Baseline in Insulin Level|An inverse relationship exists between mean change in insulin level and the mean rate of change when the degree of standard deviation is large, wherein the mean change is negative although the mean rate of change is positive or vice versa|Baseline, 3, 6, 12 months after administration and the end of study treatment （or at the occurrence of deterioration of diabetic treatment status）|Full analysis set - All participants who received at least 1 dose of open-label study drug.||μU/mL||Standard Deviation|Mean
682147|NCT01544309|Secondary|Percent Change in Insulin Level|An inverse relationship exists between mean change in insulin level and the mean rate of change when the degree of standard deviation is large, wherein the mean change is negative although the mean rate of change is positive or vice versa.|Baseline, 3, 6, 12 months after administration and the end of study treatment （or at the occurrence of deterioration of diabetic treatment status）|Full analysis set - All participants who received at least 1 dose of open-label study drug||Percent change||Standard Deviation|Mean
682148|NCT01544309|Secondary|Change in Blood Glucose Level (Fasting)||Baseline, 3, 6, 12 months after administration and the end of study treatment（or at the occurrence of deterioration of diabetic treatment status）|||mg/dL||Standard Deviation|Mean
682149|NCT01544309|Secondary|Percent Change in Blood Glucose Level (Fasting)||Baseline, 3, 6, 12 months after administration and the end of study treatment（or at the occurrence of deterioration of diabetic treatment status）|Participants in FAS except the ones who had no blood glucose level data at 12 months.||Percent change||Standard Deviation|Mean
682150|NCT01544309|Secondary|Change in HbA1c Level||Baseline, 3, 6 months after administration and the end of study treatment （or at the occurrence of deterioration of diabetic treatment status）|Full analysis set - All participants who received at least 1 dose of open-label study drug.||Amount of change (%)||Standard Deviation|Mean
682151|NCT01544309|Secondary|Percent Change in 1,5-AG Level|An inverse relationship exists between mean change in 1,5-AG level and the mean rate of change when the degree of standard deviation is large, wherein the mean change is negative although the mean rate of change is positive or vice versa|Baseline, 3, 6, 12 months after administration and the end of study treatment（or at the occurrence of deterioration of diabetic treatment status）|Participants in FAS except the ones who had no 1,5-AG data at 12 months.||Percent change||Standard Deviation|Mean
682152|NCT01544309|Secondary|Number of Participants Stratified by Time to the Occurrence of Deterioration of Diabetic Treatment Status|“Deterioration of diabetic treatment status” is defined as addition of new drug, increase in dosage, drug changes (therapy intensification), and deterioration in HbA1c of > 0.5%.|Baseline, 3, 6, 12 months after administration|Full analysis set - All participants who received at least 1 dose of open-label study drug except the ones who had no HbA1c or non-HDL-C data or a protocol deviation of the administration of study drugs.||participants|||Number
682154|NCT01544309|Primary|Change in HbA1c Level||Baseline, 12 months after administration|Participants in FAS except the ones who had no HbA1c data at 12 months.||Amount of change (%)||Standard Deviation|Mean
682168|NCT01544166|Other Pre-specified|Number of Subjects With Drug Related Serious and Non- Serious Adverse Events|An Adverse Event (AE) was any untoward medical occurrence in a subject who received study drug. A Serious AE (SAE) was an AE resulting in death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, congenital anomaly, or deemed significant for any other reason. The drug-relatedness of AEs was determined by the Investigator based on his/her clinical decision based on all available information, and was based on the question whether there was a “reasonable causal relationship” to the study treatment.|From baseline to approximately 7 days after injection|SAF included all subjects who received any amount of gadobutrol.||subjects|||Number
682169|NCT01544166|Secondary|Estimated Glomerular Filtration Rate (eGFR) Prior to Gadobutrol Injection|eGFR was calculated based on the Schwartz formula with blood sampling for serum creatinine (Scr) not exceeding 14 days prior to gadobutrol injection. Otherwise, the eGFR was obtained from the original Schwartz formula: eGFR = k * height / Scr where k = 0.45 in term newborn infants < 1 year of age, and k = 0.55 in children up to 13 years of age. If Scr was measured by an enzymatic creatinine method that had been calibrated to be traceable to Isotope dilution mass spectroscopy (IDMS), the updated Schwartz formula was used: eGFR = 0.413*height/Scr.|Before gadobutrol injection|"SAF included all subjects who received any amount of gadobutrol. Here n included subjects who were evaluable at specified age group."||milliliter/minute/1.73 square||Standard Deviation|Mean
682170|NCT01544166|Secondary|Number of Subjects With Clinically Significant Abnormal Laboratory Values|Change in post-injection test values, such as resulting in a change in subject management or which were not the result of laboratory error and were considered clinically significant by the investigator was reported.|Baseline (not exceeding 24 hours before Gadobutrol injection) up to 24 hours post injection|Safety Analysis Set (SAF) included all subjects who received any amount of gadobutrol.||subjects|||Number
682171|NCT01544166|Secondary|Number of Subjects With Change in Management From Unenhanced to Combined MRI by Body Region|"The subject management was indicated based on the unenhanced images alone. The analysis value for change in subject management was recorded as yes/no. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images."|Images were taken pre-injection and post-injection (within about 15 minutes)|FAS included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.||subjects|||Number
682172|NCT01544166|Secondary|Number of Subjects With Change in Management From Unenhanced to Combined MRI|"The subject management was indicated based on the unenhanced images alone. The analysis value for change in subject management was recorded as yes/no. Evaluation was done on pre-injection and combined (pre- and post-injection) images."|Images were taken pre-injection and post-injection (within about 15 minutes)|FAS included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.||subjects|||Number
682173|NCT01544166|Secondary|Number of Subjects With Change in Diagnosis From Combined MRI to Final Diagnosis by Body Region|"The analysis value for change in diagnosis was recorded as yes/no. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images."|Images were taken pre-injection and post-injection (within about 15 minutes)|FAS included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.||subjects|||Number
682174|NCT01544166|Secondary|Number of Subjects With Change in Diagnosis From Combined MRI to Final Diagnosis|"The analysis value for change in diagnosis was recorded as yes/no. Evaluation was done on pre- injection and combined (pre- and post-injection) images."|Images were taken pre-injection and post-injection (within about 15 minutes)|FAS included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.||subjects|||Number
682175|NCT01544166|Secondary|Number of Subjects With Change in Diagnosis From Unenhanced MRI to Final Diagnosis by Body Region|"The analysis value for change in diagnosis was recorded as yes/no. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images."|Images were taken pre-injection and post-injection (within about 15 minutes)|FAS included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.||subjects|||Number
682176|NCT01544166|Secondary|Number of Subjects With Change in Diagnosis From Unenhanced MRI to Final Diagnosis|"The analysis value for change in diagnosis was recorded as yes/no. Evaluation was done on pre- injection and combined (pre- and post-injection) images."|Images were taken pre-injection and post-injection (within about 15 minutes)|FAS included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.||subjects|||Number
682177|NCT01544166|Secondary|Number of Subjects With Change in Diagnosis From Unenhanced to Combined MRI by Body Region|"The analysis value for change in diagnosis was recorded as yes/no. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images."|Images were taken pre-injection and post-injection (within about 15 minutes)|FAS included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.||subjects|||Number
682178|NCT01544166|Secondary|Number of Subjects With Change in Diagnosis From Unenhanced to Combined MRI|"The analysis value for change in diagnosis was recorded as yes/no. Evaluation was done on pre- injection and combined (pre- and post-injection) images."|Images were taken pre-injection and post-injection (within about 15 minutes)|FAS included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.||subjects|||Number
682179|NCT01544166|Secondary|Number of Subjects With Final Diagnosis by Body Region|The final diagnosis of the subjects was based on all clinical information available and was provided separately within 4 weeks after MRI. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images. Only subjects with final diagnosis were reported.|Up to 4 weeks post-injection|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.||subjects|||Number
682180|NCT01544166|Secondary|Number of Subjects With Final Diagnosis|The final diagnosis of the subjects was based on all clinical information available and was provided separately within 4 weeks after MRI. Evaluation was done on pre-injection and combined (pre- and post- injection) images.|Up to 4 weeks post-injection|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.||subjects|||Number
682181|NCT01544166|Secondary|Number of Subjects With Confidence in Diagnosis by Body Region|Diagnostic confidence based on the unenhanced MRI image sets and thereafter on the combined MRI image sets were assessed on a 3-point scale, as 3 = Very confident, 2 = Confident, and 1 = Not confident. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images.|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.||subjects|||Number
682182|NCT01544166|Secondary|Number of Subjects With Confidence in Diagnosis|Diagnostic confidence based on the unenhanced MRI image sets and thereafter on the combined MRI image sets were assessed on a 3-point scale, as 1 = Not confident, 2 = Confident and 3 = Very confident. Evaluation was done on pre-injection and combined (pre- and post-injection) images.|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.||subjects|||Number
682461|NCT01541826|Secondary|C-reactive Protein|Fasting plasma C-reactive protein after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 6 weeks, 12 weeks|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.||pg/mL||Standard Error|Mean
682183|NCT01544166|Secondary|Number of Subjects With Additional Diagnostic Gain by Body Region|Additional diagnostic gain by the contrast-enhanced image set was assessed on a 3-point scale: scale 1 = Initial diagnosis unchanged, scale 2 = Initial diagnosis changed - improved, i.e. more specific, and scale 3 = Initial diagnosis changed -new diagnosis. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images.|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.||subjects|||Number
682184|NCT01544166|Secondary|Number of Subjects With Additional Diagnostic Gain|Additional diagnostic gain by the contrast-enhanced image set was assessed on a 3-point scale: scale 1 = Initial diagnosis unchanged, scale 2 = Initial diagnosis changed - improved, i.e. more specific, and scale 3 = Initial diagnosis changed -new diagnosis. Evaluation was done on combined (pre- and post- injection) images.|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.||subjects|||Number
682185|NCT01544166|Secondary|Number of Subjects With Diagnoses by Body Region|The following diagnoses were reported for both the unenhanced MRI and the combined MRI image sets: Other diagnoses, No lesions/normal, Congenital disease/syndrome, Malignant lesion, Inflammation, Structural malformation, Benign lesion, and Vascular malformation. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images.|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.||subjects|||Number
682186|NCT01544166|Secondary|Number of Subjects With Diagnoses|The following diagnoses were reported for both the unenhanced MRI and the combined MRI image sets: Other diagnoses, No lesions/normal, Congenital disease/syndrome, Malignant lesion, Inflammation, Structural malformation, Benign lesion, and Vascular malformation. Evaluation was done on pre- injection and combined (pre- and post-injection) images.|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.||subjects|||Number
682187|NCT01544166|Secondary|Number of Subjects by Visualization of Lesion-Internal Morphology or Homogeneity of Vessel Enhancement by Body Region|The degree of visualization of internal morphology and structure was recorded on a 3-point scale: 1 = Poor, the structure and internal morphology of the lesion or vessel is poorly visible; 2 = Moderate, the structure and internal morphology of the lesion or vessel is visible but sufficient information cannot be obtained; 3 = Good, the structure and internal morphology of the lesion or vessel is sufficiently visible for diagnostic purposes. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images.|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.||subjects|||Number
682188|NCT01544166|Secondary|Number of Subjects by Visualization of Lesion-Internal Morphology or Homogeneity of Vessel Enhancement|The degree of visualization of internal morphology and structure was recorded on a 3-point scale: 1= Poor, the structure and internal morphology of the lesion or vessel is poorly visible; 2 = Moderate, the structure and internal morphology of the lesion or vessel is visible but sufficient information cannot be obtained; 3 = Good, the structure and internal morphology of the lesion or vessel is sufficiently visible for diagnostic purposes.Evaluation was done on pre-injection and combined (pre- and post-injection) images.|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.||subjects|||Number
682189|NCT01544166|Secondary|Number of Subjects With Border Delineation of Lesion of Vessel by Body Region|The border delineation for each lesion or vessel was recorded on a 4-point scale: 1 = None, no or unclear delineation of the boundary between the lesion or vessel and the surrounding tissue; 2 = Moderate, some aspects of border delineation covered; 3 = Good, almost clear delineation, but not complete on relevant slices; 4 = Excellent, clear and complete delineation.The results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images.|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.||subjects|||Number
682190|NCT01544166|Secondary|Number of Subjects With Border Delineation of Lesion of Vessel|The border delineation for each lesion or vessel was recorded on a 4-point scale: 1 = None, no or unclear delineation of the boundary between the lesion or vessel and the surrounding tissue; 2 = Moderate, some aspects of border delineation covered; 3 = Good, almost clear delineation, but not complete on relevant slices; 4 = Excellent, clear and complete delineation.Evaluation was done on pre-injection and combined (pre- and post-injection) images.|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.||subjects|||Number
682191|NCT01544166|Secondary|Contrast Enhancement in Lesion or Vessel by Body Region|The contrast-enhancement for each lesion or vessel was recorded on a 4-point scale: 1 = None, lesion or vessel is not enhanced; 2 = Moderate, lesion or vessel is weakly enhanced; 3 = Good, lesion or vessel is clearly enhanced; 4 = Excellent, lesion or vessel is clearly and brightly enhanced. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images.|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.||subjects|||Number
682192|NCT01544166|Secondary|Contrast Enhancement in Lesion or Vessel|The contrast-enhancement for each lesion or vessel was recorded on a 4-point scale: 1 = None, lesion or vessel is not enhanced; 2 = Moderate, lesion or vessel is weakly enhanced; 3 = Good, lesion or vessel is clearly enhanced; 4 = Excellent, lesion or vessel is clearly and brightly enhanced. Evaluation was done on pre-injection and combined (pre- and post-injection) images.|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.||subjects|||Number
682193|NCT01544166|Secondary|Number of Subjects With Number of Lesions Detected by Body Region|"Presence of pathology included presence of lesions and was recorded as yes/no. If yes the number of subjects with specified lists of lesions and body region was reported. Evaluation was done on pre- injection and combined (pre- and post-injection) images. Data of subjects with missing number of lesions or at least one lesion in unenhanced and combined MRI sets were reported."|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation. 44 subjects in the FAS were analyzed. The number of subjects with presence of pathology was 33.||subjects|||Number
682194|NCT01544166|Secondary|Number of Subjects With Number of Lesions Detected|"Presence of pathology included presence of lesions and was recorded as yes/no. If yes the number of subjects with specified lists of lesions and body region was reported. Evaluation was done on pre- injection and combined (pre- and post-injection) images."|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation. 44 subjects in the FAS were analyzed. The number of subjects with presence of pathology was 33.||subjects|||Number
682195|NCT01544166|Secondary|Number of Subjects With Presence of Pathology by Body Region|"Presence of pathology was assessed for unenhanced and combined MRI sets and recorded as yes/no. The number of lesions identified for each MRI set was recorded. Results per body region were reported."|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.||subjects|||Number
682196|NCT01544166|Secondary|Number of Subjects With Presence of Pathology|"Presence of pathology was assessed for unenhanced and combined MRI sets and recorded as yes/no. The number of lesions identified for each MRI set was recorded."|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.||subjects|||Number
682197|NCT01544166|Secondary|Number of Subjects by Overall Contrast Quality by Body Region|A qualitative assessment of the overall contrast using the following pre-defined 5-point scale: 1= None (for example, in case of a non-enhancing vessel), 2= Poor, 3= Moderate, 4= Good, 5= Excellent, was done in the postcontrast MRI only, which is evaluated together with the unenhanced, this is why it is called combined. Data for combined MRI set was reported.|Images were taken post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.||subjects|||Number
682198|NCT01544166|Secondary|Number of Subjects by Overall Contrast Quality|A qualitative assessment of the overall contrast using the following pre-defined 5-point scale: 1= None (for example, in case of a non-enhancing vessel), 2= Poor, 3= Moderate, 4= Good, 5= Excellent, was done. This parameter was assessed in the postcontrast MRI only, which is evaluated together with the unenhanced, this is why it is called combined. Data for combined MRI set was reported.|Images were taken post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.||subjects|||Number
682199|NCT01544166|Secondary|Number of Subjects With Technical Adequacy for Diagnosis by Body Region|The technical adequacy of the the unenhanced image set and the combined unenhanced and enhanced image set was assessed based 4-point scale and body region. Four-point scale: 1=Region visualized with artifacts compromising quality and interpretability of images, 2=Only partial evaluation of images possible, region not covered adequately anatomically, 3=Region visualized with artifacts, partially compromising image quality but evaluation and diagnosis still possible, 4=Region clearly visualized, excellent quality. Evaluation was done on pre-injection and combined images.|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.||subjects|||Number
682200|NCT01544166|Secondary|Number of Subjects With Technical Adequacy for Diagnosis|The technical adequacy of the unenhanced image set and the combined unenhanced and enhanced image set was assessed based on the following 4 point scale: 1=Region visualized with artifacts compromising quality and interpretability of images, 2=Only partial evaluation of images possible, region not covered adequately anatomically, 3=Region visualized with artifacts, partially compromising image quality but evaluation and diagnosis still possible, 4=Region clearly visualized, excellent quality. Evaluation was done on pre-injection and combined (pre- and post-injection) images.|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.||subjects|||Number
682201|NCT01544166|Secondary|Number of Subjects With Anatomical Area Evaluated|Subjects were referred for MRI of any body region. The primary anatomical area to be evaluated by MRI was assessed. Anatomical Area was recorded prior to gadobutrol injection for the unenhanced MRI procedure and after gadobutrol injection for the gadobutrol-enhanced MRI procedure. Evaluation was done on pre-injection and combined (pre- and post-injection) images.|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.||subjects|||Number
682202|NCT01544166|Primary|Simulation of Plasma Concentration of Gadobutrol at 30 Minutes Post-Injection (C30)|Simulation is the use of the model to predict data other than observed data, in this case early Gadobutrol plasma concentration after intravenous injection. Plasma concentration serves as a surrogate for efficacy (signal and contrast enhancement) in MRI. C30 was simulated for virtual pediatric subjects with homogenous distribution over age. Simulated median (5th and 95th percentile in parenthesis) gadolinium plasma concentrations for a dose of 0.1 mmol/kg body weight were presented.|30 minutes post-injection|PPS included those subjects who received the appropriate dose of gadobutrol based on the dose specification of 0.1 mmol/kg BW plus/minus 10% and had quantifiable gadolinium plasma concentrations in at least 1 valid PK sample. C30 was simulated for 2400 virtual paediatric participants.||micromole/L||Full Range|Median
682511|NCT01540981|Secondary|Change in Mean Wound Area|Measured from randomization to last visit (14 days or at discharge from hospital)|14 days|||square centimeters||Standard Deviation|Mean
682203|NCT01544166|Primary|Simulation of Plasma Concentration of Gadobutrol at 20 Minutes Post-Injection (C20)|Simulation is the use of the model to predict data other than observed data, in this case early Gadobutrol plasma concentration after intravenous injection. Plasma concentration serves as a surrogate for efficacy (signal and contrast enhancement) in MRI. C20 was simulated for virtual pediatric subjects with homogenous distribution over age. Simulated median (5th and 95th percentile in parenthesis) gadolinium plasma concentrations for a dose of 0.1 mmol/kg body weight were presented.|20 minutes post-injection|PPS included those subjects who received the appropriate dose of gadobutrol based on the dose specification of 0.1 mmol/kg BW plus/minus 10% and had quantifiable gadolinium plasma concentrations in at least 1 valid PK sample. Here number of subjects analysed= 43. C20 was simulated for 2400 virtual paediatric participants.||micromole/L||Full Range|Median
682204|NCT01544166|Primary|Terminal Elimination Half-Life (t1/2) of Gadobutrol From Plasma: Individual|Half-life refers to the elimination of the drug, that is, the time it takes for the blood plasma concentration to reach half the concentration. Terminal elimination half-life of gadobutrol from plasma is expressed in hours and is derived from the terminal slope of the concentration versus time curve.|Blood samples were collected at 3 timepoints between 15 minutes and 8 hours post administration of gadobutrol|PPS included those subjects who received the appropriate dose of gadobutrol based on the dose specification of 0.1 mmol/kg BW plus/minus 10% and had quantifiable gadolinium plasma concentrations in at least 1 valid PK sample.||hours||Full Range|Median
682205|NCT01544166|Primary|Mean Residence Time (MRT) of Gadobutrol in Plasma: Individual|MRT is the average time that the molecules introduced into the body stay in the body. MRT of Gadobutrol is expressed in hours.|Blood samples were collected at 3 timepoints between 15 minutes and 8 hours post administration of gadobutrol|PPS included those subjects who received the appropriate dose of gadobutrol based on the dose specification of 0.1 mmol/kg BW plus/minus 10% and had quantifiable gadolinium plasma concentrations in at least 1 valid PK sample.||hours||Full Range|Median
682206|NCT01544166|Primary|Body Weight-Normalized Apparent Volume of Distribution at Steady State (Vss) of Gadobutrol in Plasma: Individual|Vss is an estimate of drug distribution independent of the elimination process and is proportional to the amount of drug in the body versus the drug plasma concentration at steady-state.|Blood samples were collected at 3 timepoints between 15 minutes and 8 hours post administration of gadobutrol|PPS included those subjects who received the appropriate dose of gadobutrol based on the dose specification of 0.1 mmol/kg BW plus/minus 10% and had quantifiable gadolinium plasma concentrations in at least 1 valid PK sample.||L/kg||Full Range|Median
682207|NCT01544166|Primary|Body Weight-Normalized Total Body Clearance (CL) of Gadobutrol From Plasma: Individual|Clearance is the volume of the fluid presented to the eliminating organ that is effectively completely cleared of drug per unit time and depends on the rate of elimination. CL of gadobutrol normalized for body weight, was reported in Liter per hour per kilogram (L/(h*kg).|Blood samples were collected at 3 timepoints between 15 minutes and 8 hours post administration of gadobutrol|PPS included those subjects who received the appropriate dose of gadobutrol based on the dose specification of 0.1 mmol/kg BW plus/minus 10% and had quantifiable gadolinium plasma concentrations in at least 1 valid PK sample.||L/(h*kg)||Full Range|Median
682208|NCT01544166|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to Infinity of Gadobutrol: Individual|AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. AUC from time 0 (start of injection) to infinity was reported in micromole*hour per liter (micromole*h/L).|Blood samples were collected at 3 timepoints between 15 minutes and 8 hours post administration of gadobutrol|Per-protocol set (PPS) included those subjects who received the appropriate dose of gadobutrol based on the dose specification of 0.1 mmol/kg BW plus/minus 10% and had quantifiable gadolinium plasma concentrations in at least 1 valid PK sample.||micromole*h/L||Full Range|Median
682209|NCT01544153|Secondary|Self-reported 30-day Point Prevalence Abstinence|"In the past 30 days, have you smoked any cigarettes at all, even a puff? Number of participants responding No, 30day point prevalence abstinence"|3 months post-randomization|Intent to treat||Participants|||Count of Participants
682210|NCT01544153|Primary|Self-reported 30-day Point Prevalence Abstinence|"In the past 30 days, have you smoked any cigarettes at all, even a puff? Number of participants responding No, 30day point prevalence abstinence."|9 months post-randomization|Intent to treat||Participants|||Count of Participants
682211|NCT01544114|Secondary|PK of Naproxen: Trough Plasma Concentrations|Trough concentration was defined as lowest plasma concentration from pre-dose to 3 hours post-dose, for each individual participant.|Month 1 and Month 3: pre-dose, and up to 3 hours post-dose|PK Analysis Set: all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK blood sample result and no protocol deviations that would have an impact on any PK assessment; participants were categorized according to the treatment medication they actually took.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
682212|NCT01544114|Secondary|PK of Esomeprazole: Oral Volume of Distribution (V/F)||pre-dose, and up to 3 hours post-dose|PK Analysis Set: all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK blood sample result and no protocol deviations that would have an impact on any PK assessment; participants were categorized according to the treatment medication they actually took.||L||Geometric Coefficient of Variation|Geometric Mean
682213|NCT01544114|Secondary|PK of Esomeprazole: Absorption Rate Constant (Ka)||pre-dose, and up to 3 hours post-dose|PK Analysis Set: all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK blood sample result and no protocol deviations that would have an impact on any PK assessment; participants were categorized according to the treatment medication they actually took.||h^-1||Geometric Coefficient of Variation|Geometric Mean
682214|NCT01544114|Secondary|PK of Esomeprazole: Oral Plasma Clearance (CL/F)||pre-dose, and up to 3 hours post-dose|PK Analysis Set: all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK blood sample result and no protocol deviations that would have an impact on any PK assessment; participants were categorized according to the treatment medication they actually took.||L/h||Geometric Coefficient of Variation|Geometric Mean
682260|NCT01543958|Secondary|Change in IL-6|Changes in levels of systemic inflammation marker IL-6 from week 8 to week 16|week 8 and week 16|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 34 subjects with valid data at both week 8 and week 16 were included in this secondary analysis.||pg/mL||Inter-Quartile Range|Median
682215|NCT01544114|Secondary|Pharmacokinetics (PK) of Esomeprazole: Area Under the Concentration-Time Curve From the Time of Dosing to the Last Measurable Concentration (AUC[0-t])||pre-dose, and up to 3 hours post-dose|PK Analysis Set: all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK blood sample result and no protocol deviations that would have an impact on any PK assessment; participants were categorized according to the treatment medication they actually took.||hr*µmol/L||Geometric Coefficient of Variation|Geometric Mean
682216|NCT01544114|Primary|Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation (DC) of Study Drug|An AE is defined as the development of an undesirable medical condition or the deterioration of a preexisting medical condition, whether or not considered causally related to treatment. An SAE is defined as an AE occurring during any study phase (ie, run-in, treatment, washout, follow-up), that fulfils one or more of the following criteria: results in death; is immediately life-threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is a congenital abnormality or birth defect; is an important medical event that may jeopardize the participant or may require medical intervention to prevent one of the outcomes listed above. AEs were considered treatment-emergent if they occurred after the first dose of study drug. Events were categorized as mild, moderate, and severe; participants were represented only with the maximum reported intensity.|SAEs were collected from signing of informed consent through Month 6 (or end of treatment) plus 14 days. AEs were collected from administration of VIMOVO through Month 6 (or end of treatment) plus 14 days.|Safety analysis set: all participants who received at least 1 dose of study drug; participants were categorized according to the treatment medication they actually took.||participants|||Number
682217|NCT01544062|Secondary|48 Hour Dizziness|Opioid related adverse effects were recorded using a numeric scale (0 = no adverse effects, 1 = mild adverse effects not requiring treatment, 2 = moderate adverse effects requiring treatment and 3 = severe adverse effects refractory to treatment). Presence of dizziness was defined as numeric scale response 1 (mild adverse effects not requiring treatment), 2 (moderate adverse effects requiring treatment) or 3 (severe adverse effects refractory to treatment).|48 hours after arriving in ICU|Missing data on 7 study subjects in normal saline group and 4 study subjects in IV acetaminophen group.||participants|||Number
682218|NCT01544062|Secondary|24 Hour Dizziness|Opioid related adverse effects were recorded using a numeric scale (0 = no adverse effects, 1 = mild adverse effects not requiring treatment, 2 = moderate adverse effects requiring treatment and 3 = severe adverse effects refractory to treatment). Presence of dizziness was defined as numeric scale response 1 (mild adverse effects not requiring treatment), 2 (moderate adverse effects requiring treatment) or 3 (severe adverse effects refractory to treatment).|24 hours after arriving in ICU|Missing data on 3 study subjects in normal saline group.||participants|||Number
682219|NCT01544062|Secondary|48 Hour Respiratory Depression|Opioid related adverse effects were recorded using a numeric scale (0 = no adverse effects, 1 = mild adverse effects not requiring treatment, 2 = moderate adverse effects requiring treatment and 3 = severe adverse effects refractory to treatment). Presence of respiratory depression was defined as numeric scale response 1 (mild adverse effects not requiring treatment), 2 (moderate adverse effects requiring treatment) or 3 (severe adverse effects refractory to treatment).|48 hours after arriving in ICU|Missing data on 6 study subjects in normal saline group and 3 study subjects in IV acetaminophen group.||participants|||Number
682220|NCT01544062|Secondary|24 Hour Respiratory Depression|Opioid related adverse effects were recorded using a numeric scale (0 = no adverse effects, 1 = mild adverse effects not requiring treatment, 2 = moderate adverse effects requiring treatment and 3 = severe adverse effects refractory to treatment). Presence of respiratory depression was defined as numeric scale response 1 (mild adverse effects not requiring treatment), 2 (moderate adverse effects requiring treatment) or 3 (severe adverse effects refractory to treatment).|24 hours after arriving in ICU|Missing data on 3 study subjects in normal saline group.||participants|||Number
682221|NCT01544062|Secondary|48 Hour Sedation|Opioid related adverse effects were recorded using a numeric scale (0 = no adverse effects, 1 = mild adverse effects not requiring treatment, 2 = moderate adverse effects requiring treatment and 3 = severe adverse effects refractory to treatment). Presence of sedation was defined as numeric scale response 1 (mild adverse effects not requiring treatment), 2 (moderate adverse effects requiring treatment) or 3 (severe adverse effects refractory to treatment).|48 hours after arriving in ICU|Missing data on 6 study subjects in normal saline group and 3 study subjects in IV acetaminophen group.||participants|||Number
682222|NCT01544062|Secondary|24 Hour Sedation|Opioid related adverse effects were recorded using a numeric scale (0 = no adverse effects, 1 = mild adverse effects not requiring treatment, 2 = moderate adverse effects requiring treatment and 3 = severe adverse effects refractory to treatment). Presence of sedation was defined as numeric scale response 1 (mild adverse effects not requiring treatment), 2 (moderate adverse effects requiring treatment) or 3 (severe adverse effects refractory to treatment).|24 hours after arriving in ICU|Missing data on 3 study subjects in normal saline group.||participants|||Number
682223|NCT01544062|Secondary|48 Hour Pruritus|Opioid related adverse effects were recorded using a numeric scale (0 = no adverse effects, 1 = mild adverse effects not requiring treatment, 2 = moderate adverse effects requiring treatment and 3 = severe adverse effects refractory to treatment). Presence of pruritus was defined as numeric scale response 1 (mild adverse effects not requiring treatment), 2 (moderate adverse effects requiring treatment) or 3 (severe adverse effects refractory to treatment).|48 hours after arriving in ICU|Missing data on 8 study subjects in normal saline group and 6 study subjects in IV acetaminophen group.||participants|||Number
682224|NCT01544062|Secondary|24 Hour Pruritus|Opioid related adverse effects were recorded using a numeric scale (0 = no adverse effects, 1 = mild adverse effects not requiring treatment, 2 = moderate adverse effects requiring treatment and 3 = severe adverse effects refractory to treatment). Presence of pruritus was defined as numeric scale response 1 (mild adverse effects not requiring treatment), 2 (moderate adverse effects requiring treatment) or 3 (severe adverse effects refractory to treatment).|24 hours after arriving in ICU|Missing data on 3 study subjects in normal saline group.||participants|||Number
682299|NCT01543607|Secondary|Effectiveness: Change From Baseline in Bile Duct Diameter.|Effectiveness will be determined by change in stricture diameter (increase or decrease) after RFA procedure. This will be measure as percentage change in improvement of the stricture.|2 years|||percentage of improvement:|||Number
682225|NCT01544062|Secondary|48 Hour Nausea|Opioid related adverse effects were recorded using a numeric scale (0 = no adverse effects, 1 = mild adverse effects not requiring treatment, 2 = moderate adverse effects requiring treatment and 3 = severe adverse effects refractory to treatment). Presence of nausea was defined as numeric scale response 2 (moderate adverse effects requiring treatment) or 3 (severe adverse effects refractory to treatment).|48 hours after arriving in ICU|||participants|||Number
682226|NCT01544062|Secondary|24 Hour Nausea|Opioid related adverse effects were recorded using a numeric scale (0 = no adverse effects, 1 = mild adverse effects not requiring treatment, 2 = moderate adverse effects requiring treatment and 3 = severe adverse effects refractory to treatment). Presence of nausea was defined as numeric scale response 2 (moderate adverse effects requiring treatment) or 3 (severe adverse effects refractory to treatment).|24 hours after arriving in ICU|||participants|||Number
682227|NCT01544062|Secondary|48 Hour Patient Satisfaction|"The extent to which subjects overall pain experience met their expectations question responses were converted to the Likert scale with the following values: not at all (1), a little (2), a fair amount (3), very much (4) and extremely well (5)."|48 hours after arriving in ICU|Questionnaire not completed by 12 study subjects in normal saline group and 10 study subjects in IV acetaminophen group.||units on a scale||Standard Deviation|Mean
682228|NCT01544062|Secondary|Length of ICU Stay|The length of ICU stay will be determined based on the “ICU Discharge Criteria” checklist that will be completed by nursing staff every 4 hours until ICU discharge.|From the time of arrival in ICU until ICU discharge|||hours||Standard Deviation|Mean
682229|NCT01544062|Secondary|Length of Mechanical Ventilation|The length of mechanical ventilation will be determined based on the “Extubation Criteria” checklist that will be completed by nursing staff every 2 hours until extubation.|From the time of arrival in ICU until extubation|||minutes||Standard Deviation|Mean
682230|NCT01544062|Secondary|48 Hour Wound Hyperalgesia|Wound hyperalgesia will be determined by testing the right side of the chest along five horizontal lines vertically separated by 2 cm at right angles to the incision using 180 gram von Frey filament (# 6.45).|48 hours after arriving in ICU|Missing data on 2 study subjects in normal saline group.||cm||Standard Deviation|Mean
682231|NCT01544062|Secondary|24 Hour Wound Hyperalgesia|Wound hyperalgesia will be determined by testing the right side of the chest along five horizontal lines vertically separated by 2 cm at right angles to the incision using 180 gram von Frey filament (# 6.45).|24 hours after arriving in ICU|Missing data on 3 study subjects in normal saline group.||cm||Standard Deviation|Mean
682232|NCT01544062|Secondary|48 Hour Postoperative Pain Scores With Movement|Pain scores at rest will be recorded on Numeric Rating Scale by nursing staff. The Numeric Rating Scale ranges from 0 to 10 (0 - no pain, 1-2-3 - mild pain, 4-5-6 - moderate pain, 7-8-9 - severe pain, 10 - worst pain imaginable).|48 hours after arriving in ICU|Missing data on 2 study subjects in normal saline group.||units on a scale||Standard Deviation|Mean
682233|NCT01544062|Secondary|24 Hour Postoperative Pain Scores With Movement|Pain scores at rest will be recorded on Numeric Rating Scale by nursing staff. The Numeric Rating Scale ranges from 0 to 10 (0 - no pain, 1-2-3 - mild pain, 4-5-6 - moderate pain, 7-8-9 - severe pain, 10 - worst pain imaginable).|24 hours after arriving in ICU|Missing data on 3 study subjects in normal saline group.||units on a scale||Standard Deviation|Mean
682234|NCT01544062|Secondary|48 Hour Postoperative Pain Scores at Rest|Pain scores at rest will be recorded on Numeric Rating Scale by nursing staff. The Numeric Rating Scale ranges from 0 to 10 (0 - no pain, 1-2-3 - mild pain, 4-5-6 - moderate pain, 7-8-9 - severe pain, 10 - worst pain imaginable).|48 hours after arriving in ICU|Missing data on 2 study subjects in normal saline group.||units on a scale||Standard Deviation|Mean
682235|NCT01544062|Secondary|24 Hour Postoperative Pain Scores at Rest|Pain scores at rest will be recorded on Numeric Rating Scale by nursing staff. The Numeric Rating Scale ranges from 0 to 10 (0 - no pain, 1-2-3 - mild pain, 4-5-6 - moderate pain, 7-8-9 - severe pain, 10 - worst pain imaginable).|24 hours after arriving in ICU|Missing data for 3 study subjects in normal saline group.||units on a scale||Standard Deviation|Mean
682236|NCT01544062|Secondary|48 Hour Postoperative Opioid Consumption|48 hour postoperative opioid consumption will be obtained from the electronic medication administration record and expressed in morphine equivalents.|48 hours after arriving in ICU|Missing data for 1 study subject in normal saline group.||mg||Standard Deviation|Mean
682237|NCT01544062|Primary|24 Hour Postoperative Opioid Consumption|The 24 hour postoperative opioid consumption will be obtained from the electronic medication administration record and expressed in morphine equivalents.|24 hours after arriving in ICU|Missing data for 1 study subject in normal saline group.||mg||Standard Deviation|Mean
682238|NCT01544023|Secondary|Complication Rate|Secondary study outcome was the prevalence of complications.|2 years|||percentage of participants|||Number
682239|NCT01544023|Primary|Participants Who Received TiLOOP Mesh Reconstruction|Primary study endpoint was the identification of patient- and surgical factors predictive of adverse outcome and to develop recommendations for patients eligible for implant based breast reconstruction (IBBR) using TCPM.|1 month|||Patients with TiLOOP mesh reconstruction|||Number
682240|NCT01543958|Secondary|Primary Adverse Events|Number of subjects experiencing primary adverse events, defined as all reported Grade ≥ 2 signs and symptoms, Grade ≥ 2 laboratory abnormalities and other serious adverse events (SAEs)|baseline and week 16|All 40 subjects enrolled in A5296 were included in this analysis.||participants|||Number
682241|NCT01543958|Secondary|Change in Fasting Glucose|Change in fasting glucose from week 8 to week 16|week 8 and week 16|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 34 subjects with valid data at both week 8 and week 16 were included in this secondary analysis.||mg/dL||Inter-Quartile Range|Median
682242|NCT01543958|Secondary|Change in Fasting Glucose|Change in fasting glucose from baseline to week 8, where baseline value is the average of pre-entry and entry|baseline and week 8|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects had valid data at both baseline and week 8 and were included in this secondary analysis.||mg/dL||Inter-Quartile Range|Median
682243|NCT01543958|Secondary|Change in Non-HDL Cholesterol|Change in non-HDL cholesterol from week 8 to week 16|week 8 and week 16|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 33 subjects with valid data at both week 8 and week 16 were included in this secondary analysis.||mg/dL||Inter-Quartile Range|Median
682244|NCT01543958|Secondary|Change in Non-HDL Cholesterol|Change in non-HDL cholesterol from baseline to week 8, where baseline value is the average of pre-entry and entry|baseline and week 8|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 35 subjects with valid data at both baseline and week 8 were included in this secondary analysis.||mg/dL||Inter-Quartile Range|Median
682245|NCT01543958|Secondary|Change in HDL Cholesterol|Change in fasting HDL cholesterol from week 8 to week 16|from week 8 to week 16|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 33 subjects with valid data at both week 8 and week 16 were included in this secondary analysis.||mg/dL||Inter-Quartile Range|Median
682246|NCT01543958|Secondary|Change in HDL Cholesterol|Change in fasting HDL cholesterol from baseline to week 8, where baseline value is the average of pre-entry and entry|baseline and week 8|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 35 subjects with valid data at both baseline and week 8 were included in this secondary analysis.||mg/dL||Inter-Quartile Range|Median
682247|NCT01543958|Secondary|Change in LDL Cholesterol|Change in fasting LDL cholesterol from week 8 to week 16|week 8 and week 16|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 32 subjects with valid data at both week 8 and week 16 were included in this secondary analysis.||mg/dL||Inter-Quartile Range|Median
682248|NCT01543958|Secondary|Change in LDL Cholesterol|Change in fasting LDL cholesterol from baseline to week 8, where baseline value is the average of pre-entry and entry|baseline and week 8|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 34 subjects with valid data at both baseline and week 8 were included in this secondary analysis.||mg/dL||Inter-Quartile Range|Median
682249|NCT01543958|Secondary|Change in Total Cholesterol|Change in total cholesterol from week 8 to week 16|week 8 and week 16|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 33 subjects with valid data at both week 8 and week 16 were included in this secondary analysis.||mg/dL||Inter-Quartile Range|Median
682250|NCT01543958|Secondary|Change in Total Cholesterol|Change in total cholesterol from baseline to week 8, where baseline value is the average of pre-entry and entry|baseline and week 8|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 35 subjects with valid data at both baseline and week 8 were included in this secondary analysis.||mg/dL||Inter-Quartile Range|Median
682251|NCT01543958|Secondary|Change in Tissue Factor|Change in levels of coagulation biomarker tissue factor from week 8 to week 16|week 8 and week 16|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 34 subjects with valid data at both week 8 and week 16 were included in this secondary analysis.||pg/mL||Inter-Quartile Range|Median
682252|NCT01543958|Secondary|Change in Tissue Factor|Change in levels of coagulation biomarker tissue factor from baseline to week 8, where baseline value is the average of pre-entry and entry|baseline and week 8|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects had valid data at both baseline and week 8 were included in this secondary analysis.||pg/mL||Inter-Quartile Range|Median
682253|NCT01543958|Secondary|Change in Tissue Factor|Change in levels of coagulation biomarker tissue factor from baseline to week 4, where baseline value is the average of pre-entry and entry|baseline and week 4|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects with valid data at both baseline and week 4 were included in this secondary analysis.||pg/mL||Inter-Quartile Range|Median
682254|NCT01543958|Secondary|Change in D-dimer|Change in levels of coagulation biomarker d-dimer from week 8 to week 16|week 8 and week 16|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 34 subjects with valid data at both week 8 and week 16 were included in this secondary analysis.||ng/mL||Inter-Quartile Range|Median
682255|NCT01543958|Secondary|Change in D-dimer|Change in levels of coagulation biomarker d-dimer from baseline to week 8, where baseline value is the average of pre-entry and entry|baseline and week 8|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects with valid data at both baseline and week 8 were included in this secondary analysis.||ng/mL||Inter-Quartile Range|Median
682256|NCT01543958|Secondary|Change in D-dimer|Change in levels of coagulation biomarker d-dimer from baseline to week 4, where baseline value is the average of pre-entry and entry|baseline and week 4|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects with valid data at both baseline and week 4 were included in this secondary analysis.||ng/mL||Inter-Quartile Range|Median
682257|NCT01543958|Secondary|Change in CRP|Changes in levels of systemic inflammation marker CRP from week 8 to week 16, where baseline is the average of pre-entry and entry|week 8 and week 16|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 34 subjects with valid data at both week 8 and week 16 were included in this secondary analysis.||ng/mL||Inter-Quartile Range|Median
682258|NCT01543958|Secondary|Change in CRP|Changes in levels of systemic inflammation marker CRP from baseline to week 8, where baseline is the average of pre-entry and entry|Baseline and Week 8|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects with valid data at both baseline and week 8 were included in this secondary analysis.||ng/mL||Inter-Quartile Range|Median
682259|NCT01543958|Secondary|Change in C-reactive Protein (CRP)|Changes in levels of systemic inflammation marker CRP from baseline to week 4, where baseline is the average of pre-entry and entry|baseline and week 4|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects with valid data at both baseline and week 4 were included in this secondary analysis.||ng/mL||Inter-Quartile Range|Median
682261|NCT01543958|Secondary|Change in IL-6|Changes in levels of systemic inflammation marker IL-6 from baseline to week 8, where baseline is the average of pre-entry and entry|baseline and week 8|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects with valid data at both baseline and week 8 were included in this secondary analysis.||pg/mL||Inter-Quartile Range|Median
682262|NCT01543958|Secondary|Change in IL-6|Changes in levels of systemic inflammation marker IL-6 from baseline to week 4, where baseline is the average of pre-entry and entry|baseline and week 4|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All subjects had valid data at both baseline and week 4 and were included in this secondary analysis.||pg/mL||Inter-Quartile Range|Median
682263|NCT01543958|Secondary|Change in CD4+ T-cell Counts|Change in CD4+ T-cell counts from week 8 to week 16|week 8 and week 16|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 34 subjects with valid data at both week 8 and week 16 were included in this secondary analysis.||cells/mm^3||Inter-Quartile Range|Median
682264|NCT01543958|Secondary|Change in CD4+ T-cell Counts|Change in CD4+ T-cell counts from baseline to week 8, where baseline is the average of pre-entry and entry|baseline and week 8|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 36 subjects with valid data at both baseline and week 8 were included in this secondary analysis.||cells/mm^3||Inter-Quartile Range|Median
682265|NCT01543958|Secondary|Change in CD4+ T-cell Counts|Change in CD4+ T-cell counts from baseline to week 4, where baseline is the average of pre-entry and entry|baseline and week 4|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 35 subjects with valid data at both baseline and week 4 were included in this secondary analysis.||cells/mm^3||Inter-Quartile Range|Median
682266|NCT01543958|Secondary|Change in log10 HIV RNA Levels|Change in log10 HIV RNA levels from week 8 to week 16|week 8 and week 16|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 34 subjects with valid data at both week 8 and week 16 were included in this secondary analysis.||log10(copies/mL)||Inter-Quartile Range|Median
682267|NCT01543958|Secondary|Change in log10 HIV RNA Levels|Change in log10 HIV RNA levels from baseline to week 8, where baseline value is the average of pre-entry and entry|baseline and week 8|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects had valid data at both baseline and week 8 and were included in this secondary analysis.||log10(copies/mL)||Inter-Quartile Range|Median
682268|NCT01543958|Secondary|Change in log10 HIV RNA Levels|Change in log10 HIV RNA levels from baseline to week 4, where baseline value is the average of pre-entry and entry|baseline and week 4|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects had valid data at both baseline and week 4 and were included in this secondary analysis.||log10(copies/mL)||Inter-Quartile Range|Median
682269|NCT01543958|Secondary|Change in Blood Phosphate Levels|Change in blood phosphate levels from week 8 to week 16|from week 8 to week 16|Among 40 subjects enrolled in A5296, 34 subjects with valid data at both week 8 and week 16 were included in this secondary analysis.||mg/dL||Inter-Quartile Range|Median
682270|NCT01543958|Secondary|Change in Blood Phosphate Levels|Change in blood phosphate levels from baseline to week 8|Baseline to Week 8|Among 40 subjects enrolled in A5296, 37 subjects with valid data at both baseline and week 8 were included in this secondary analysis.||mg/dL||Inter-Quartile Range|Median
682271|NCT01543958|Secondary|Change in Blood Phosphate Levels|Change in blood phosphate levels from baseline to week 4, where baseline value is the average of pre-entry and entry|from baseline to week 4|Among 40 subjects enrolled in A5296, 39 subjects with valid data at both baseline and week 4 were included in this secondary analysis.||mg/dL||Inter-Quartile Range|Median
682272|NCT01543958|Secondary|Change in Proportion of Cycling CD4+|Change from week 8 to week 16 in cycling CD4+ , defined as the %Ki67+|week 8 and week 16|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 29 subjects with valid data at both week 8 and week 16 were included in this secondary analysis.||percentage||Inter-Quartile Range|Median
682273|NCT01543958|Secondary|Change in Proportion of Cycling CD4+|Change from baseline to week 8 in cycling CD4+ , defined as the %Ki67+, where baseline value is the average of pre-entry and entry|baseline and week 8|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 32 subjects with valid data at both baseline and week 8 were included in this secondary analysis.||percentage||Inter-Quartile Range|Median
682274|NCT01543958|Secondary|Change in Proportion of Cycling CD4+|Change from baseline to week 4 in cycling CD4+ , defined as the %Ki67+, where baseline value is the average of pre-entry and entry|baseline and week 4|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects had valid data at both baseline and week 4 and were included in this secondary analysis.||percentage||Inter-Quartile Range|Median
682275|NCT01543958|Secondary|Change in Proportion of Cycling CD8+|Change from week 8 to week 16 in cycling CD8+ , defined as the %Ki67+|from week 8 to week 16|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 29 subjects with valid data at both week 8 and week 16 were included in this secondary analysis.||percentage||Inter-Quartile Range|Median
682276|NCT01543958|Secondary|Change in Proportion of Cycling CD8+|Change from baseline to week 8 in cycling CD8+ , defined as the %Ki67+, where baseline value is the average of pre-entry and entry|baseline and week 8|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 32 subjects with valid data at baseline and week 8 were included in this secondary analysis.||percentage||Inter-Quartile Range|Median
682594|NCT01539538|Primary|Patient Global Satisfaction|Proportion of patients responding good or excellent at 48-hour global assessment of method of pain control|48 hours|||% patients reporting good or excellent||95% Confidence Interval|Number
682277|NCT01543958|Secondary|Change in Proportion of Cycling CD8+|Change from baseline to week 4 in cycling CD8+ , defined as the %Ki67+, where baseline value is the average of pre-entry and entry|baseline and week 4|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects have valid data at baseline and week 4 and were included in this secondary analysis.||percentage||Inter-Quartile Range|Median
682278|NCT01543958|Secondary|Change in CD8+ T-cell Activation|Change in CD8+ T-cell activation defined as the %CD38+/HLA-DR+ from week 8 to week 16|week 8 and week 16|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 30 subjects with valid data at week 8 and week 16 were included in this secondary analysis.||percentage||Inter-Quartile Range|Median
682279|NCT01543958|Secondary|Change in CD8+ T-cell Activation|Change in CD8+ T-cell activation defined as the %CD38+/HLA-DR+ from baseline to week 8, where baseline is the average of pre-entry and entry|Baseline and Week 8|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 33 subjects with valid data at baseline and week 8 were included in this secondary analysis.||percentage||Inter-Quartile Range|Median
682280|NCT01543958|Secondary|Change in CD8+ T-cell Activation|Change from baseline to week 4 in CD8+ T-cell activation, defined as the %CD38+/HLA-DR+, where baseline value is the average of pre-entry and entry|baseline and week 4|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 35 subjects with valid data at baseline and week 4 were included in this secondary analysis.||percentage||Inter-Quartile Range|Median
682281|NCT01543958|Secondary|Change in CD4+ T-cell Activation|Change from week 8 to week 16 in CD4+ T-cell activation, defined as the %CD38+/HLA-DR+|week 8 and week 16|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 30 subjects with valid data at week 8 and week 16 were included in this secondary analysis.||percentage||Inter-Quartile Range|Median
682282|NCT01543958|Secondary|Change in CD4+ T-cell Activation|Change from baseline to week 4 in CD4+ T-cell activation, defined as the %CD38+/HLA-DR+, where baseline value is the average of pre-entry and entry|baseline and week 4|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 35 subjects with valid data at baseline and week 4 were included in this secondary analysis.||percentage||Inter-Quartile Range|Median
682283|NCT01543958|Secondary|Change in CD4+ T-cell Activation|Change from baseline to week 8 in CD4+ T-cell activation, defined as the %CD38+/HLA-DR+, where baseline value is the average of pre-entry and entry|baseline and week 8|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 33 subjects with valid data at baseline and week 8 were included in this secondary analysis.||percentage||Inter-Quartile Range|Median
682284|NCT01543958|Secondary|Change in sCD14|Change in sCD14 from week 8 to week 16|week 8 and week 16|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 34 subjects had valid data at both week 8 and week 16 and were included in this secondary analysis.||ug/mL||Inter-Quartile Range|Median
682285|NCT01543958|Secondary|Change in sCD14|Change in sCD14 from baseline to week 4, where baseline value is the average of pre-entry and entry|baseline and week 4|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects have valid data at baseline and week 4 and were included in this secondary analysis.||ug/mL||Inter-Quartile Range|Median
682286|NCT01543958|Secondary|Change in Endotoxin|Change in endotoxin from week 8 to week 16|week 8 and week 16|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 33 subjects with valid endpoint at both week 8 and week 16 were included in this secondary analysis.||pg/mL||Inter-Quartile Range|Median
682287|NCT01543958|Secondary|Change in Endotoxin|Change in endotoxin from baseline to week 4, where baseline value is the average of pre-entry and entry|baseline and week 4|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects had valid data at both baseline and week 4 and were included in this secondary analysis.||pg/mL||Inter-Quartile Range|Median
682288|NCT01543958|Primary|Change in Soluble CD14 (sCD14)|Change in soluble CD14 (sCD14) from baseline to week 8, where baseline value is the average of pre-entry and entry|baseline and week 8|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects had valid data at both baseline and week 8 and were included in primary analysis.||ug/mL||Inter-Quartile Range|Median
682289|NCT01543958|Primary|Change in Endotoxin|Change in LPS from baseline to week 8, where baseline value is the average of pre-entry and entry values.|baseline and Week 8|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects had valid data at both baseline and week 8 and were included in primary analysis.||pg/mL||Inter-Quartile Range|Median
682290|NCT01543828|Primary|Time (in Minutes) to Patient's Perception of Onset of Effect|"Defined as the first time point that the patient responds yes to the following self-administered question:
I feel that the drug is working in improving my breathing?"|5, 7.5, 10, 15, 20, 30, 40, 50, and 60 minutes post dose for treatment 1 and treatment 2|Full Analysis Set included all participants who received one dose of study drug.||Minutes||Standard Deviation|Mean
682300|NCT01543607|Secondary|Feasibility: Ease of the Radiofrequency Ablation Catheter Placement|Determine the feasibility of radiofrequency ablation catheter placement across malignant strictures with using a subjective scale, 0 is being impossible to place the catheter and 10 is being very easy to place the catheter.|2 years|||units on a scale|||Number
682301|NCT01543607|Primary|Safety: Number of Bile Leak After RFA Procedure|Determination of safety will be measured by the presence of a bile leak( bile leak will be defined by contrast cholangiography)|2 years|||bile leak|||Number
682600|NCT01539512|Secondary|Overall Survival|Overall survival was defined as the interval from randomization to death from any cause.|Up to 17 months|ITT Analysis Set: randomized participants with treatment group designated according to initial randomization.||months||95% Confidence Interval|Median
682291|NCT01543685|Secondary|TOTPAR-48. Total Pain Relief (TOTPAR) Over 0 to 48 Hours|"Pain relief was assessed using a 5-point categorical scale at all assessment time points after time 0. Subjects were asked “How much relief have you had since your starting pain?” with response choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4.
The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. In this way individual scores covering a longer time period were given more weight. The minimum theoretical score is 0 units, which represent no relief from pain (score of 0 on categorical scale) at all time points after time 0. The maximum theoretical score is 192 units, which represents complete relief from pain (score of 4 on a categorical scale) at all time points after time 0."|0 - 48 hours|Intent to Treat Population||units on a scale*hour||Standard Deviation|Mean
682292|NCT01543685|Secondary|TOTPAR-24. Total Pain Relief (TOTPAR) Over 0 to 24 Hours|"Pain relief was assessed using a 5-point categorical scale at all assessment time points after time 0. Subjects were asked “How much relief have you had since your starting pain?” with response choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4.
The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. In this way individual scores covering a longer time period were given more weight. The minimum theoretical score is 0 units, which represent no relief from pain (score of 0 on categorical scale) at all time points after time 0. The maximum theoretical score is 96 units, which represents complete relief from pain (score of 4 on a categorical scale) at all time points after time 0."|0 - 24 hours|Intent to Treat Population||units on a scale*hour||Standard Deviation|Mean
682293|NCT01543685|Secondary|TOTPAR-8. Total Pain Relief (TOTPAR) Over 0 to 8 Hours|"Pain relief was assessed using a 5-point categorical scale at all assessment time points after time 0. Subjects were asked “How much relief have you had since your starting pain?” with response choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4.
The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. In this way individual scores covering a longer time period were given more weight. The minimum theoretical score is 0 units, which represent no relief from pain (score of 0 on categorical scale) at all time points after time 0. The maximum theoretical score is 32 units, which represents complete relief from pain (score of 4 on a categorical scale) at all time points after time 0."|0 - 8 hours|Intent to Treat Population||units on a scale*hour||Standard Deviation|Mean
682294|NCT01543685|Secondary|Total Pain Relief (TOTPAR) Over 0 to 4 Hours (TOTPAR-4).|"Pain relief was assessed using a 5-point categorical scale at all assessment time points after time 0. Subjects were asked “How much relief have you had since your starting pain?” with response choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4.
The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. In this way individual scores covering a longer time period were given more weight. The minimum theoretical score is 0 units, which represent no relief from pain (score of 0 on categorical scale) at all time points after time 0. The maximum theoretical score is 16 units, which represents complete relief from pain (score of 4 on a categorical scale) at all time points after time 0."|0 - 4 hours|Intent to Treat Population||units on a scale*hour||Standard Deviation|Mean
682295|NCT01543685|Secondary|VASSPID-24. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 24 Hours After Trial Entry|"The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing No Pain and 100 mm representing Worst Possible Pain.
The VAS summed pain intensity difference (VASSPID) is calculated as a time-weighted sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment."|0 - 24 hours|Intent to Treat Population||mm*hour||Standard Deviation|Mean
682296|NCT01543685|Secondary|VASSPID-8. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 8 Hours After Trial Entry.|"The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing No Pain and 100 mm representing Worst Possible Pain.
The VAS summed pain intensity difference (VASSPID) is calculated as the sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment."|0 - 8 hours|Intent to Treat Population||mm*hour||Standard Deviation|Mean
682297|NCT01543685|Secondary|VASSPID-4. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 4 Hours After Trial Entry.|"The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing No Pain and 100 mm representing Worst Possible Pain.
The VAS summed pain intensity difference (VASSPID) is calculated as the sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment."|0 - 4 hours|Intent to Treat Population||mm*hour||Standard Deviation|Mean
682298|NCT01543685|Primary|The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale From 0 to 48 Hours After Trial Entry (VASSPID-48)|"The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing No Pain and 100 mm representing Worst Possible Pain.
The VAS summed pain intensity difference (VASSPID) is calculated as the sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment."|0 - 48 hours|Intent to Treat Population||mm*hour||Standard Deviation|Mean
682303|NCT01543581|Primary|Mohs Micrographic Surgery (MMS)|The final wound size taken immediately after the completion of Mohs surgery (i.e., upon reaching tumor-free tissue margins) was determined using pre treatment lesion outlined plus one additional concentric 2mm margin removed to establish an objective consistent measure for wound size. The diameter of the final wound size was measured in mm.|The Mohs surgical excision of the target tumor was performed within two weeks, after the last day of treatment.|||mm|||Number
682304|NCT01543568|Secondary|Mean Number of 0.2 mg Aflibercept Injections Administered||at 6 months|||injections||Full Range|Mean
682305|NCT01543568|Secondary|Quantitative Change in Area (μ) From Baseline in Choroidal Neovascular Lesion Characteristics/Size as Measured by FA/Fundus Photos||6 Months|Given lack of visual benefit upon switching to aflibercept (Eylea), such analyses were not performed.|||||
682306|NCT01543568|Secondary|Mean Change in Visual Acuity (BCVA)|Change in Early Treatment of Diabetic Retinopathy Study Best Corrected Visual Acuity (ETDRS-BCVA) from baseline to month 6. BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|6 Months|||ETDRS BCVA letters||Full Range|Mean
682307|NCT01543568|Secondary|The Percentage of Patients Who Lose > 15 Letters Visual Acuity||6 Months|||Percentage of patients|||Number
682308|NCT01543568|Secondary|Average Time to Resolution of Intraretinal Cysts and Sub Retinal Fluid on OCT||6 months|||months||Full Range|Mean
682309|NCT01543568|Secondary|Mean Change in OCT Central Foveal Thickness||6 Months|||micrometers||Full Range|Mean
682310|NCT01543568|Primary|The Number of Patients With no Fluid on OCT||6 months|||participants|||Number
682311|NCT01543503|Secondary|Change From Baseline in Patient Global Assessment of Disease Activity|"The patient's global assessment of disease activity is assessed on a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). A negative change from Baseline indicated improvement."|Baseline, Week 24, Week 52|The effectiveness analysis population was used for analysis. n = the number of participants available for assessment at a given time point||scores on a scale||95% Confidence Interval|Least Squares Mean
682312|NCT01543503|Secondary|Shift From Baseline in Morning Stiffness|Shift tables presenting the number of participants in each bivariate category Week (W) 0 versus Week 24 and Week 52, with regards to morning stiffness at the different time points, was presented for each treatment arm. For participants who experienced joint stiffness while waking up in the morning, duration of morning stiffness was categorized as follows: Less than 30 minutes (min), Between 30 and 60 minutes, Between 60 and 120 minutes, Between 120 to 240 minutes, More than 240 minutes and the whole day. Baseline = BL|Baseline, Week 24, Week 52|The effectiveness analysis population was used for analysis.||participants|||Number
682313|NCT01543503|Secondary|Mean Change From Baseline in Visual Analogue Scale Pain Score|VAS is a 100 mm scale. Intensity of pain range: 0 mm=no pain to 100 mm=worst possible pain. Change from baseline =scores at observation minus score at baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Baseline, Week 24, Week 52|The effectiveness analysis population was used for analysis. n = the number of participants available for assessment at a given time point.||units on a scale||95% Confidence Interval|Least Squares Mean
682314|NCT01543503|Secondary|Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue Score|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. The sum of all responses resulted in the FACIT-F score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the participant's health status.|Baseline, Week 24, Week 52|The effectiveness analysis population was used for analysis. n = the number of participants available for assessment at a given time point.||scores on a scale||95% Confidence Interval|Least Squares Mean
682315|NCT01543503|Secondary|Mean Change From Baseline in Health Assessment Questionnaire Disability Index Score|The Health Assessment Questionnaire-Disability Index (HAQ-DI) is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and activities of daily living). Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area). HAQ-DI total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation.|Baseline, Week 24, Week 52|The effectiveness analysis population was used for analysis. n = the number of participants available for assessment at a given time point.||Scores on a scale||95% Confidence Interval|Least Squares Mean
682316|NCT01543503|Secondary|Number of Participants With Serious and Non-serious Adverse Events of Special Interest, Including Infections, During the Study|Adverse events of special interest (AESI) for this study included: infections (including opportunistic infections), myocardial infarction/acute coronary syndrome, gastrointestinal perforation and related events, malignancies, anaphylaxis / hypersensitivity reactions, demyelinating disorders, stroke, bleeding events and hepatic events. Based on seriousness criteria, they were categorized as serious and non-serious adverse events of special interest.|Up to Week 52|The safety population was used for analysis.||participants|||Number
682317|NCT01543503|Secondary|Number of Participants With Adverse Events, Serious Adverse Events and Non-serious Adverse Events|An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.|Up to Week 52|The safety population was used for analysis.||participants|||Number
682318|NCT01543503|Secondary|Number of Participants of Infusion Reactions or Injection Site Reactions During the Study Following the Start of the First Biologic Therapy|An infusion reaction was defined as an adverse event (AE) occurring during and within 24 hours after the infusion, which may include hypersensitivity reactions or anaphylactic reactions. Injection site reactions were included in the summaries for infusion reactions.|Up to Week 52|The safety population was used for analysis.||participants|||Number
682319|NCT01543503|Secondary|Cumulative Number of Participants Who Discontinued Biologic Therapy at the End of Each Study Period|The total number of participants who discontinued biologic therapy at the end of each study period (Week 0 - 24, Week 24 - 52, Week 52 - 57 and Week 57 - end of treatment) is presented. Participants who did not have a biologic therapy discontinuation or discontinued before having one, were considered as ‘censored’ at the date study termination.|Up to end of treatment|The safety population was used for analysis.||participants|||Number
682320|NCT01543503|Secondary|Reasons for Treatment Discontinuation|The reasons for discontinuation of tocilizumab or TNF inhibitor is presented.|Up to Week 52|The safety population was used for analysis.||participants|||Number
682321|NCT01543503|Secondary|Proportion of Participants Who Terminated Biologic Treatment|The proportion of participants who discontinued biologic treatment was compared between tocilizumab-treated and TNF inhibitor-treated participants.|Up to Week 52|The safety population was used for analysis.||Percentage of participants|||Number
682322|NCT01543503|Secondary|Loss of Efficacy or Development of Intolerance to Biologic Therapy|Events that are clearly consistent with the expected pattern of progression of the underlying disease may contribute to lack of efficacy. Lack of efficacy was one of the reasons for termination of biology therapy. The number of participants showing lack of efficacy to biologic therapy is presented.|Up to Week 52|The safety population included all recruited participants who received at least one dose of a TNF inhibitor or tocilizumab during the study.||participants|||Number
682323|NCT01543503|Secondary|Mean Change From Baseline in Physician Global Assessment Score|The Physician’s Global Assessment of disease activity was assessed using a 0 to 100 millimeter (mm) horizontal VAS. The left-hand extreme of the line equals 0 mm, and is described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as “maximum disease activity” (maximum arthritis disease activity). Change from baseline = scores at observation minus score at baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Baseline, Week 24, Week 52|The effectiveness analysis population was used for analysis. n = the number of participants available for assessment at a given time point.||scores on a scale||95% Confidence Interval|Least Squares Mean
682324|NCT01543503|Secondary|Mean Change From Baseline in Clinical Disease Activity Index and Simplified Disease Activity Index Score|Clinical Disease Activity Index (CDAI) was calculated as the sum of the following parameters: SJC + TJC + VAS Patient Global Assessment of Disease Activity + VAS Physician Global Assessment of Disease Activity. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity'. CDAI scores ranged from 0 to 76, with higher scores indicating increased disease activity. Simplified Disease Activity Index (SDAI) was calculated as the sum of the following parameters: SJC +TJC + Patient Global Assessment of Disease Activity + Physician Global Assessment of Disease Activity + CRP. SDAI scores ranged from 0 to 86, with higher scores also indicating increased disease activity.|Baseline, Week 24, Week 52|The effectiveness analysis population was used for analysis. n = the number of participants available for assessment at a given time point.||units on a scale||95% Confidence Interval|Least Squares Mean
682325|NCT01543503|Secondary|Mean Change From Baseline in Tender Joint Count|A tender joint count (TJC) is the most specific clinical method to quantify abnormalities in participants with RA. It is associated with the level of pain. Twenty-eight joints were assessed for tenderness. Joints were classified as tender (1)/not tender (0) giving a total possible TJC score of 0 to 28.|Baseline, Week 24, Week 52|The effectiveness analysis population was used for analysis. n = the number of participants available for assessment at a given time point.||Number of tender joints||95% Confidence Interval|Least Squares Mean
682326|NCT01543503|Secondary|Mean Change From Baseline in Swollen Joint Count|A swollen joint count (SJC) is the most specific clinical method to quantify abnormalities in participants with RA. It reflects the amount of inflamed synovial tissue. Twenty-eight joints were assessed for swelling. Joints were classified as swollen (1)/ not swollen (0) giving a total possible SJC score of 0 to 28.|Baseline, Week 24, Week 52|The effectiveness analysis population was used for analysis. n = the number of participants available for assessment at a given time point.||Number of swollen joints||95% Confidence Interval|Least Squares Mean
682327|NCT01543503|Secondary|Mean Change From Baseline in C-reactive Protein|Blood samples were collected for C-reactive protein (CRP). CRP is an inflammation marker. High levels of this protein indicate inflammation in diseases such as RA.|Baseline, Week 24, Week 52|The effectiveness analysis population was used for analysis. n = the number of participants available for assessment at a given time point||mg/L||95% Confidence Interval|Least Squares Mean
682328|NCT01543503|Secondary|Mean Change From Baseline in Erythrocyte Sedimentation Rate|Blood samples were collected for ESR, which is an acute phase reactant and a measure of inflammation. BL = baseline.|Baseline, Week 24, Week 52|The effectiveness analysis population was used for analysis. n = the number of participants available for assessment at a given time point.||mm/hr||95% Confidence Interval|Least Squares Mean
682329|NCT01543503|Secondary|Mean Change From Baseline in Disease Activity Score Based on 28 Joint Count Erythrocyte Sedimentation Rate at Week 52|Disease activity score based on 28 joint counts (DAS28) is a composite measure of disease severity and it incorporates four specific measures of disease: swollen joint count (SJC) of 28 joints, tender joint count (TJC) of 28 joints, Patient’s Global Assessment of Disease Activity by visual analogue scale (VAS), and acute-phase inflammatory marker (ESR in mm/h, or CRP in mg/L). For the purposes of this study, ESR was used whenever possible to calculate the DAS28 (DAS28-ESR). Higher the scores, greater is the disease activity. A DAS28 score of </= 3.2 = low disease activity, a DAS28 score of >3.2 to 5.1 = moderate to high disease activity.|Baseline and Week 52|The effectiveness analysis population was used for analysis. Data of participants available at the time of the assessment were included in the analysis.||units on a scale||95% Confidence Interval|Least Squares Mean
682330|NCT01543503|Primary|Mean Change From Baseline in Calculated Disease Activity Score Based on 28 Joint Count Erythrocyte Sedimentation Rate at Week 24|Disease activity score based on 28 joint counts (DAS28) is a composite measure of disease severity and it incorporates four specific measures of disease: swollen joint count (SJC) of 28 joints, tender joint count (TJC) of 28 joints, Patient’s Global Assessment of Disease Activity by visual analogue scale (VAS), and acute-phase inflammatory marker [erythrocyte sedimentation rate (ESR) in millimeter/hour (mm/h), or C-reactive protein (CRP) in milligram/liter (mg/L)]. For the purposes of this study, ESR was used whenever possible to calculate the DAS28 (DAS28-ESR). Higher the scores, greater is the disease activity. A DAS28 score of less than or equal to (</=) 3.2 = low disease activity, a DAS28 score of >3.2 to 5.1 = moderate to high disease activity.|Baseline and Week 24|Participants belonging to the safety population who had first biologic administration within 60 days after the last Rheumatoid Arthritis (RA) disease activity assessment were included in the effectiveness analysis population. Data of participants available at the time of the assessment were included in the analysis.||Units on a scale||95% Confidence Interval|Least Squares Mean
682331|NCT01543204|Secondary|Number of Participants With Adverse Events|A treatment-related adverse event is defined as an event that is deemed by the investigator to be related to investigational product.|From first dose of study drug until 30 days after the last dose (up to 28 weeks)|Primary analysis set||participants|||Number
682332|NCT01543204|Secondary|Change From Baseline in Patient Assessment of Flaking|The severity of the participants pain was individually assessed by the participant. Participants were asked to circle a number between 0 and 10 to describe their flaking, with 0 indicating “no flaking at all” and 10 indicating “worst flaking imaginable.” Change from baseline was calculated as Baseline Value - Post-baseline Value, hence a positive change indicates improvement.|Baseline and Week 12 and 24|Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used. n indicates the number of participants included in the analysis at each time point.||units on a scale||Standard Deviation|Mean
682333|NCT01543204|Secondary|Change From Baseline in Patient Assessment of Pain|The severity of the participants pain was individually assessed by the participant. Participants were asked to circle a number between 0 and 10 to describe how much their psoriasis hurts today, with 0 indicating “does not hurt at all” and 10 indicating “worst hurt imaginable.” Change from baseline was calculated as Baseline Value - Post-baseline Value, hence a positive change indicates improvement.|Baseline and Week 12 and 24|Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used. n indicates the number of participants included in the analysis at each time point.||units on a scale||Standard Deviation|Mean
682334|NCT01543204|Secondary|Change From Baseline in Patient Assessment of Itch|The severity of the participants itch was individually assessed by the participant. Participants were asked to circle a number between 0 and 10 to describe their itch, with 0 indicating “no itch at all” and 10 indicating “worst itch imaginable.” Change from baseline was calculated as Baseline Value - Post-baseline Value, hence a positive change indicates improvement.|Baseline and Week 12 and 24|Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used. n indicates the number of participants included in the analysis at each time point.||units on a scale||Standard Deviation|Mean
682335|NCT01543204|Secondary|Change From Baseline in Work Productivity and Activity Impairment (WPAI)|The impact of disease severity on the participant’s ability to participate in work and other activities was evaluated using the WPAI. WPAI consists of six questions to assess whether the participant was currently employed (Q1); how many hours from work were missed due to problems associated with psoriasis (Q2) or any other reason (Q3); hours actually worked (Q4); degree that psoriasis affected productivity while working (Q5); and degree that psoriasis affected regular activities (Q6) over the past 7 days. Four separate overall scores were calculated, including absenteeism (work time missed due to health), presenteeism (impairment at work due to health), work productivity loss (overall work impairment due to health), and activity impairment due to health. Each score ranges from 0 to 100 with higher scores indicating greater impairment and less productivity. Change from baseline was calculated as Baseline Value - Post-baseline Value, hence a positive change indicates improvement.|Baseline and Weeks 12 and 24|Primary analysis set participants with at least 1 post-baseline value and who were employed (for the first 3 scores); LOCF imputation was used. n indicates the number of participants included in the analysis at each time point.||units on a scale||Standard Deviation|Mean
682336|NCT01543204|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score|The dermatology life quality index (DLQI) is a skin disease-specific instrument to evaluate health-related quality of life. The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answered 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is from 0 (best possible score) to 30 (worst possible score). Change from baseline was calculated as Baseline Value – Post-baseline Value, hence a positive change indicates improvement.|Baseline and Weeks 12 and 24|Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used. n indicates the number of participants included in the analysis at each time point.||units on a scale||Standard Deviation|Mean
682337|NCT01543204|Secondary|Patient Satisfaction With Treatment at Week 24|Participants indicated their level of satisfaction with the medication’s control of psoriasis on a scale from “very dissatisfied” to “very satisfied”.|Week 24|Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.||percentage of participants||95% Confidence Interval|Number
682338|NCT01543204|Secondary|Patient Satisfaction With Treatment at Week 12|Participants indicated their level of satisfaction with the medication’s control of psoriasis on a scale from “very dissatisfied” to “very satisfied”.|Week 12|Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.||percentage of participants||95% Confidence Interval|Number
682364|NCT01543074|Primary|Cmax of Sulforaphane and Its Metabolites in Blood|"The levels of Sulforaphane and its metabolites (combined) in blood was measured using Liquid Chromatrography-Mass Spectrometry (LC-MS) methods. Cmax (mean +/- SD) values are shown in the Outcome Measure Data Table."|Before breakfast (0 hours) and 1, 3 and 6 hours after breakfast & pills on Days 1 & 7, and before breakfast on Days 8, 9 and 14.|||micromoles/L||Standard Deviation|Mean
682339|NCT01543204|Secondary|Percent Change From Baseline in the Percentage of BSA Involved With Psoriasis by Anti-adalimumab Antibody Status|A measurement of psoriasis involvement, given as the physician’s assessment of the percentage of the participant’s total body surface area (BSA) involved with psoriasis. The percent of BSA affected was estimated by assuming that the participant’s palm, excluding the fingers and thumb, represented roughly 1% of the body’s surface. Percent change from baseline was calculated as (Baseline Value – Post-baseline Value) / Baseline Value * 100, hence a positive value indicates improvement.|Baseline and weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with available data||percent change||Standard Deviation|Mean
682340|NCT01543204|Secondary|Percent Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis|A measurement of psoriasis involvement, given as the physician’s assessment of the percentage of the participant’s total body surface area (BSA) involved with psoriasis. The percent of BSA affected was estimated by assuming that the participant’s palm, excluding the fingers and thumb, represented roughly 1% of the body’s surface. Percent change from baseline was calculated as (Baseline Value – Post-baseline Value) / Baseline Value * 100, hence a positive value indicates improvement.|Baseline and Weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.||percent change||Standard Deviation|Mean
682341|NCT01543204|Secondary|Percent Change From Baseline in PASI by Anti-adalimumab Antibody Status|The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis. Percent change from baseline was calculated as (Baseline Value – Post-baseline Value) / Baseline Value * 100, hence a positive value indicates improvement.|Baseline and weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with available data||percent change||Standard Deviation|Mean
682342|NCT01543204|Secondary|Percent Change From Baseline in Psoriasis Area and Severity Index (PASI)|The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis. Percent change from baseline was calculated as (Baseline Value – Post-baseline Value) / Baseline Value * 100, hence a positive value indicates improvement.|Baseline and Weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.||percent change||Standard Deviation|Mean
682343|NCT01543204|Secondary|Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline by Anti-adalimumab Antibody Status|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). The percentage of participants with an improvement from baseline of ≥ 2 grades is reported.|Baseline and weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with available data||percentage of participants||95% Confidence Interval|Number
682344|NCT01543204|Secondary|Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). The percentage of participants with an improvement from baseline of ≥ 2 grades is reported.|Baseline and Weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.||percentage of participants||95% Confidence Interval|Number
682345|NCT01543204|Secondary|Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline by Anti-adalimumab Antibody Status|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). The percentage of participants with an improvement from baseline of ≥ 1 grade is reported.|Baseline and weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with available data||percentage of participants||95% Confidence Interval|Number
682346|NCT01543204|Secondary|Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). The percentage of participants with an improvement from baseline of ≥ 1 grade is reported.|Baseline and Weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.||percentage of participants||95% Confidence Interval|Number
682347|NCT01543204|Secondary|Percentage of Participants With a PASI 90 Response by Anti-adalimumab Antibody Status at Each Visit|A PASI 90 response is a 90% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis.|Baseline and weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with available data||percentage of participants||95% Confidence Interval|Number
682348|NCT01543204|Secondary|Percentage of Participants With a PASI 90 Response at Each Visit|A PASI 90 response is a 90% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis.|Baseline and Weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.||percentage of participants||95% Confidence Interval|Number
682349|NCT01543204|Secondary|Percentage of Participants With a PASI 75 Response by Anti-adalimumab Antibody Status at Each Visit|A PASI 75 response is a 75% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis.|Baseline and weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with available data||percentage of participants||95% Confidence Interval|Number
682350|NCT01543204|Secondary|Percentage of Participants With a PASI 75 Response at Each Visit|A PASI 75 response is a 75% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis.|Baseline and Weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.||percentage of participants||95% Confidence Interval|Number
682351|NCT01543204|Secondary|Percentage of Participants With a PASI 50 Response by Anti-adalimumab Antibody Status at Each Visit|A PASI 50 response is a 50% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis.|Baseline and weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with available data||percentage of participants||95% Confidence Interval|Number
682352|NCT01543204|Secondary|Percentage of Participants With a PASI 50 Response at Each Visit|A PASI 50 response is a 50% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis.|Baseline and Weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.||percentage of participants||95% Confidence Interval|Number
682353|NCT01543204|Secondary|Static Physician Global Assessment (sPGA) by Anti-adalimumab Antibody Status at Each Visit|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema).|Weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with available data||units on a scale||Standard Deviation|Mean
682354|NCT01543204|Secondary|Static Physician Global Assessment (sPGA) at Each Visit|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema).|Weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.||units on a scale||Standard Deviation|Mean
682355|NCT01543204|Secondary|Percentage of Participants With an sPGA Score of 0, 1 or 2 by Anti-adalimumab Antibody Status at Each Visit|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). The percentage of participants with a score of 0 (clear), 1 (almost clear) or 2 (mild) is reported.|Weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with available data||percentage of participants||95% Confidence Interval|Number
682356|NCT01543204|Secondary|Percentage of Participants With an sPGA Score of 0, 1 or 2 at Each Visit|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). The percentage of participants with a score of 0 (clear), 1 (almost clear) or 2 (mild) is reported.|Weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.||percentage of participants||95% Confidence Interval|Number
682357|NCT01543204|Secondary|Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at All Other Visits by Anti-adalimumab Antibody Status|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).|Weeks 4, 8, 16, 20 and 24|Primary analysis set participants with available data||percentage of participants||95% Confidence Interval|Number
682358|NCT01543204|Secondary|Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at All Other Visits|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).|Weeks 4, 8, 16, 20 and 24|Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.||percentage of participants||95% Confidence Interval|Number
682359|NCT01543204|Primary|Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 12 by Anti-adalimumab Antibody Status|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).|Week 12|The primary analysis set with available data||percentage of participants||95% Confidence Interval|Number
682360|NCT01543204|Primary|Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 12|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).|Week 12|The primary analysis set (all participants who received at least one dose of investigational product during the study) with at least 1 post-baseline value. Participants with missing post-baseline data were imputed using the last observation carried forward (LOCF) method.||percentage of participants||95% Confidence Interval|Number
682361|NCT01543178|Primary|Repeat Treatment Responders|Subjects who respond to repeat treatment in both IBS-related abdominal pain and stool consistency. The proportion of patients who responded to repeat treatment during the first double-blind repeat treatment phase is presented. Response is defined as improvement from baseline in abdominal pain AND reduction from baseline in diarrhea.|4-week treatment-free follow-up in double-blind repeat treatment phase.|Intent-to-treat population, defined as patients who received ≥ 1 dose of study drug in the double-blind period.||percentage of patients|||Number
682362|NCT01543074|Primary|Tmax of Sulforaphane and Its Metabolites in Blood|"The levels of Sulforaphane and its metabolites (combined) in blood was measured using Liquid Chromatrography-Mass Spectrometry (LC-MS) methods. The time to achieve highest plasma concentration (Tmax) is shown in the Outcome Measure Data Table."|Before breakfast (0 hours) and 1, 3 and 6 hours after breakfast & pills on Days 1 & 7, and before breakfast on Days 8, 9 and 14.|||hours||Standard Deviation|Mean
682363|NCT01543074|Secondary|Histone Acetylation|Change in histone acetylation|21 days||||||
682365|NCT01542957|Secondary|Change From Baseline in Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) at the End of Therapy, 3 and12 Month Follow-up|To assess subjective well-being, symptoms or problems, life functioning, and risk. The Total score is reported, which is the sum of the ratings of all items divided by the number of items (34). The score and ranges from 0 to 4, with higher scores indicating more severity of psychological distress.|End of therapy, 3 and 12 month follow-up|The overall number of participants analyzed are those who completed the treatment but not all of them completed follow-up assessments at 3 and 12-month after the end of the therapy. In each row the number of those participants who completed the assessment are specified||units on a scale||Standard Deviation|Mean
682366|NCT01542957|Secondary|Change From Baseline in Hamilton-Depression Rating Scale-17 Items|This clinician-administered measure was only applied to 78 patients at pre- and posttreatment. It measures severity of depressive symptoms. The Total score is reported, which is the sum of the ratings of all items and ranges from 0 to 54, with higher scores indicating more severity of depressive symptoms.|End of therapy and 12-month follow-up|The overall number of participants analyzed are those who completed the treatment but not all of them completed follow-up assessments at 3 and 12-month after the end of the therapy. In each row the number of those participants who completed the assessment are specified.||units on a scale||Standard Deviation|Mean
682367|NCT01542957|Primary|Change From Baseline in Beck Depression Inventory-Second Edition (BDI-II) at the End of Therapy, 3 and 12-month Follow-up|To assess change in severity of depressive symptoms. The Total score is reported, which is the sum of the ratings of all items and ranges from 0 to 63, with higher scores indicating more severity of depressive symptoms.|End of therapy (16 weeks), 3 and 12-month follow-up|The overall number of participants analyzed are those who completed the treatment but not all of them completed follow-up assessments at 3 and 12-month after the end of the therapy. In each row the number of those participants who completed the assessment are specified||units on a scale||Standard Deviation|Mean
682368|NCT01542788|Secondary|Percentage of Participants Experiencing Viral Relapse|Viral relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement|End of treatment to post-treatment Week 24|Participants in the Full Analysis Set who had an end-of-treatment response (HCV RNA < LLOQ as the last observed on-treatment value) were analyzed.||percentage of participants|||Number
682369|NCT01542788|Secondary|Percentage of Participants Experiencing Viral Breakthrough|Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment, confirmed with 2 consecutive values (second confirmation value could be posttreatment), or last available on-treatment measurement with no subsequent follow-up values|Baseline to Week 12|Full Analysis Set||percentage of participants|||Number
682370|NCT01542788|Secondary|Percentage of Participants Achieving SVR24|SVR24 was defined as HCV RNA < LLOQ 24 weeks after cessation of therapy|Post-treatment Week 24|Full Analysis Set||percentage of participants|||Number
682371|NCT01542788|Secondary|Percentage of Participants Achieving SVR4|SVR4 was defined as HCV RNA < LLOQ 4 weeks after cessation of therapy|Post-treatment Week 4|Full Analysis Set||percentage of participants|||Number
682372|NCT01542788|Primary|Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug|The number of subjects experiencing adverse events leading to permanent discontinuation of study drug was summarized. Adverse events may or may not have been related to study treatment.|Baseline to Week 12|Safety Analysis Set: participants were randomized and received at least 1 dose of study drug||participants|||Number
682373|NCT01542788|Primary|Percentage of Participants Achieving SVR12|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ, ie, < 25 IU/mL) 12 weeks after cessation of therapy|Post-treatment Week 12|Full Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized into the study and received at least 1 dose of study drug||percentage of participants|||Number
682374|NCT01542684|Primary|Overall Response Rate (ORR)|ORR is percentage total participants with overall response (Complete Response (CR) or Partial Response (PR)) within two treatment cycles. Response based on modified International Working Group (IWG) criteria: Complete response - Bone marrow: 5% myeloblasts with normal maturation of all cell lines, Persistent dysplasia noted, Peripheral blood Hgb 11 g/dL, Platelets 100x109/L, Neutrophils 1.0x109/L, Blasts 0%. Partial response: All CR criteria if abnormal before treatment except: Bone marrow blasts decreased by 50% over pretreatment but still > 5% , Cellularity and morphology not relevant; Stable disease - Failure to achieve at least PR, but no evidence of progression for > 8 weeks; No Response or Failure - Death during treatment or disease progression characterized by worsening of cytopenias, increase in percentage of bone marrow blasts, or progression to a more advanced MDS French-American-British (FAB) classification subtype than pretreatme|Baseline up to 2 treatment cycles (8 weeks)|||percentage of participants|||Number
682375|NCT01542645|Secondary|Marker of Myocardial Injury (Troponin I)|In a cohort of patients undergoing only coronary artery bypass graft surgery (n=75), serum troponins will be measured postoperatively to determine whether methadone has a potential cardioprotective effect.|12 hours after surgery|||nanograms per millimeter||Full Range|Median
682376|NCT01542645|Secondary|Chronic Postoperative Pain Scores||1,3,6, and 12 months after surgery||||||
682377|NCT01542645|Secondary|Postoperative Pain Scores|Pain was assessed on a 11-point verbal analogue scale with 0=no pain, 10=worst pain imaginable|2 hours after cardiac surgery|||units on a scale||Full Range|Median
682378|NCT01542645|Primary|Total Opioid Consumption in the Postoperative Period|Total intravenous morphine used first three days (72 hours after ICU admission)|First 3 days after surgery|||milligrams||Full Range|Median
682379|NCT01542632|Primary|Rate of Seroconversion to Each of Four Dengue Serotypes|Rate of seroconversion was defined as the percentage of participants with Plaque Reduction Neutralization Test titer resulting in 50 % reduction in Plagues (PRNT50) titer ≥ 10 for participants seronegative at Baseline or a greater than four-fold increase in PRNT50 for participants seropositive at Baseline.|Up to 30 days after the last immunization (Up to Day 120)|Participants from the Full Analysis Set, all enrolled participants, with data available at the given time-point.||percentage of participants|||Number
682380|NCT01542632|Secondary|Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes||Days 30, 90 and 120 after 1st vaccination|Participants from the Full Analysis, all enrolled participants, with data available for analysis at the given time-point.||titer||Standard Deviation|Geometric Mean
682381|NCT01542632|Primary|Number of Participants With at Least 1 Adverse Events Related to TDV Following Either Vaccine Dose|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. Some AEs are automatically considered related because of temporal relationship to vaccination.|For 30 days after each dose (Up to Day 120)|Safety Population included all enrolled participants who received at least one dose of study drug.||participants|||Number
682382|NCT01542632|Primary|Number of Participants With at Least 1 Adverse Event Following Either Vaccine Dose|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug.|For 30 days after each dose (Up to Day 120)|Safety Population included all enrolled participants who received at least one dose of study drug.||participants|||Number
682383|NCT01542632|Secondary|Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations|Serotype-Specific TDV Viral RNA was assessed for the four dengue serotypes: Dengue-1, Dengue-2, Dengue-3 and Dengue-4 . Only those serotypes and time-points where at least 1 participant had Serotype-Specific TDV Viral RNA Detected is reported.|various timepoints up to 30 days after each dose (Up to Day 120)|Full Analysis Set included all enrolled participants.||percentage of participants|||Number
682384|NCT01542632|Primary|Number of Participants With Injection Site Reactions Following Either Vaccine Dose Worst Severity Reported|Erythema and Edema Were Graded Per The FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Where Grade 0=none to Grade 4=Severe. Pain and Itching were graded using Common Terminology Criteria for Adverse Events (CTCAE) 4.03 where Grade 0=no pain or itching to Grade 4= Life-threatening/severe. Only those score categories for which there was at least 1 participant are reported.|Day 0 to Day 104|Safety population included all enrolled participants who received at least one dose of study drug.||participants|||Number
682387|NCT01542528|Secondary|Overall Improvement|Clinical Global Improvement Scale (CGI-I) - responders vs. non-responders. CGI is a seven point scale with the following anchor point: 1=Very Much Improved, 2=Much Improved, 3=Improved, 4=No change, 5=Minimally worse, 6=Much worse, 7=Very much worse. Participants with a score of 1, 2, or 3 at Endpoint were considered Responders; all others were considered non-responders.|15 weeks for a total of 60 IBBS sessions vs. treatment as usual (TAU)|The analysis population are those with matched cases at 15 weeks.||Percentage of participants|||Number
682388|NCT01542528|Primary|Improvement in ADHD Severity From Baseline to End of Intervention|ADHD severity was measured by the Swanson, Nolan, and Pelham Rating Scale (SNAP)-IV-ADHD consists of 18 items that closely parallel in wording the diagnostic symptoms for ADHD as they appear in the DSM-IV. The range of scores are from 0 to 54. Higher scores indicate greater ADHD severity . The blinded assessors (Clinicians) used clinical judgement to provide an overall rating, based on all available information from the parents, teachers, and the assessors' own direct interactions with the child on the day of the assessment.|End of intervention is at a maximum of 15 weeks from baseline.|The analysis population are those with matched cases at 15 weeks.||units on a scale||Standard Deviation|Mean
682389|NCT01542502|Other Pre-specified|Ventilatory Efficiency (VE/VCO2 [Carbon Dioxide] Slope)|Interval change from baseline in ventilatory efficiency (VE/VCO2 slope) upon completion of 2 weeks treatment.|14 days||||||
682390|NCT01542502|Other Pre-specified|Inflammatory Biomarkers|Interval change from baseline in high-sensitivity C-reactive protein upon completion of 2 weeks treatment.|28 days||||||
682391|NCT01542502|Other Pre-specified|Adverse Events|Additional endpoints will include assessment of adverse events and hospitalizations during 4-week duration of study.|28 days||||||
682392|NCT01542502|Other Pre-specified|Heart Failure Symptoms (DASI)|Interval change from baseline in Heart Failure (HF) symptoms as measured by Duke Activity Status Index (DASI) upon completion of 2 weeks treatment.|28 days||||||
682393|NCT01542502|Other Pre-specified|Correlation Between Endpoints|Correlation between interval change in peak VO2 and high sensitivity C-reactive protein|28 days||||||
682394|NCT01542502|Secondary|Exercise Time|Interval change from baseline in duration of exercise during a standardized cardiopulmonary exercise test upon completion of 2 weeks treatment|14 days|||minutes||Inter-Quartile Range|Median
682395|NCT01542502|Primary|Peak Oxygen Consumption (Peak VO2)|The primary endpoint is the change in peak oxygen consumption among stable heart failure patients (n = 12) following 14-days treatment with daily doses of Anakinra 100 mg (SC, subcutaneous).|14 days|||ml*kg^-1*min^-1||Inter-Quartile Range|Median
682396|NCT01542372|Secondary|Change in the SF-12 at 12 Weeks in Step II|A measure of severity of self-perceived functioning. Total score ranges from 0 to 100, with a higher score indicating better self-perceived functioning. Change scores were calculated.|Baseline and 12 weeks|||units on a scale||Standard Deviation|Mean
682397|NCT01542372|Secondary|Change in the Cambodian Culturally Sensitive Complaint Profile at 12 Weeks in Step II|A measure of somatic symptoms and cultural syndromes commonly found among distressed Cambodian refugees. Each item is rated on a 0-4 Likert-type scale, with a higher score indicating worse psychopathology. Mean scale scores were used, giving a minimum of 0 and a maximum of 4. Change scores were calculated.|Baseline and 12 weeks|||units on a scale||Standard Deviation|Mean
682398|NCT01542372|Secondary|Change in the SCL Anger Severity at 12 Weeks in Step II|A measure of anger severity, which is the SCL Anger Scale. Each item is rated on a 0-4 Likert-type scale, with a higher score indicating worse psychopathology. Mean scale scores were used, giving a minimum of 0 and a maximum of 4. Change scores were calculated.|Baseline and 12 weeks|||units on a scale||Standard Deviation|Mean
682439|NCT01541865|Secondary|Sudden Cardiac Death at Time of Procedure||Duration of the procedure (average of 65 minutes)|||participants|||Number
682440|NCT01541865|Secondary|Myocardial Infarction at Time of Procedure||Duration of the procedure (average of 65 minutes)|||participants|||Number
682399|NCT01542372|Secondary|Change in the HSCL Depression Scale at 12 Weeks in Step II|A measure of depression severity, which is the HSCL Depression Scale. Each item is rated on a 1-4 Likert-type scale, with a higher score indicating worse psychopathology. Mean scale scores were used, giving a minimum of 1 and a maximum of 4. Change scores were calculated.|Baseline and 12 weeks|||units on a scale||Standard Deviation|Mean
682400|NCT01542372|Secondary|Change in the HSCL Anxiety Scale at 12 Weeks in Step II|A measure of anxiety severity, which is the HSCL Anxiety Scale. Each item is rated on a 1-4 Likert-type scale, with a higher score indicating worse psychopathology. Mean scale scores were used, giving a minimum of 1 and a maximum of 4. Change scores were calculated.|Baseline and 12 weeks|||units on a scale||Standard Deviation|Mean
682401|NCT01542372|Primary|Change in the PTSD Checklist (PCL) at 12 Weeks in Step II|A measure of PTSD severity, which is the PTSD Checklist. Total score range is 17 to 85, with a higher score indicating greater psychopathology. Change scores were calculated.|Baseline and 12 weeks|Patients with PTSD checklist scores of 30 or above were eligible for Step II, which was medication augmentation or CBT augmentation.||units on a scale||Standard Deviation|Mean
682402|NCT01542307|Other Pre-specified|Post-gas Therapy Medication Use|The percentage of migraine attacks requiring the use of one or more anti-migraine medications after the period of gas inhalation, was selected as a secondary outcome measure.|60 minutes|||percentage of attacks|Migraine attacks||Number
682403|NCT01542307|Secondary|Final Nausea Score 0-1 on the Visual Analog Scale (VAS)|"The percentage of migraine attacks with the final (60 minute) VAS nausea score 0-1 was selected as a secondary outcome measure.
The VAS scale has a range from 0-10 with higher scores indicating greater severity of symptoms."|60 minutes|||percentage of attacks|Migraine attacks||Number
682404|NCT01542307|Secondary|Final Visual Symptom Score 0-1 on the Visual Analog Scale (VAS)|"The percentage of migraine attacks with the final (60 minute) VAS visual symptom score 0-1 was selected as a secondary outcome measure.
The VAS scale has a range from 0-10 with higher scores indicating greater severity of symptoms."|60 minutes|||percentage of attacks|Migraine attacks||Number
682405|NCT01542307|Secondary|Final Pain Score 0-1 or Score Improved 3 or More Points on the Visual Analogue Scale (VAS)|"The percentage of migraine attacks with the final (60 minute) VAS pain score either 0-1, or a 3-point improvement from baseline, was selected as a secondary outcome measure.
The VAS scale has a range from 0-10 with higher scores indicating greater severity of symptoms."|60 minutes|||percentage of attacks|Migraine attacks||Number
682406|NCT01542307|Secondary|Final Pain Severity Score 0–1 on the Visual Analogue Scale (VAS)|"The percentage of migraine attacks with the final (60 minute) VAS pain score 0-1 was selected as a secondary outcome measure.
The VAS scale has a range from 0-10 with higher scores indicating greater severity of symptoms."|60 minutes|||percentage of attacks|Migraine attacks||Number
682407|NCT01542307|Secondary|Change in Pain Score From 0-60 Minutes on the Visual Analogue Scale (VAS)|"The mean change in VAS pain scores from 0 minutes to 60 minutes was selected as a secondary outcome measure.
The VAS scale has a range from 0-10 with higher scores indicating greater severity of symptoms."|Baseline (0 minutes) to 60 minutes|||units on a scale|Migraine attacks|Standard Deviation|Mean
682408|NCT01542307|Secondary|Change in Pain Score From 0-15 Minutes on the Visual Analogue Scale (VAS)|"The mean change in VAS pain scores from 0 minutes to 15 minutes was selected as a secondary outcome measure.
The VAS scale has a range from 0-10 with higher scores indicating greater severity of symptoms."|Baseline (0 minutes) to 15 minutes|||units on a scale|Migraine attacks|Standard Deviation|Mean
682409|NCT01542307|Primary|Change in Pain Scores From 0-30 Minutes on a Visual Analog Scale (VAS)|"The mean change in VAS pain scores from 0 minutes to 30 minutes was selected as the primary outcome measure.
The VAS scale has a range from 0-10 with higher scores indicating greater severity of symptoms."|From baseline (0 minutes) to 30 mins|Number of migraine attacks treated with Oxygen or Medical Air||units on a scale|Migraine attacks|Standard Deviation|Mean
682410|NCT01542255|Secondary|Clinical Response Rate|To be assigned a status of partial response or complete response, changes in tumor measurements must be confirmed by repeat assessments that should be performed no less than 4 weeks after the criteria for response are first met. In the case of stable disease, follow-up measurements must have met the stable disease criteria at least once after study entry at a minimum interval (in general, not less than 6-8 weeks) that is defined in the study protocol|Tumor evaluation will be performed every 8 weeks from day1 of cycle 1 (+ 1 week) while on therapy, clinical response will be assessed no less than 4 weeks after response criteria met.||||||
682411|NCT01542255|Primary|Progression Free Survival|Tumor evaluation will be performed every 8 weeks from day 1 of cycle 1 (+/- 1 week) while on therapy assessed by RECIST 1.0 criteria.|From date of registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months|||weeks||Full Range|Median
682412|NCT01542125|Primary|Pain|"A horizontal 100 mm anchored Visual Analogue Scale (0 = no pain, 100 = worst possible pain) was used by the adult caregiver and the orthopedic technician to document the pain associated with Perc Pin removal for participant children.
The Oucher Scale was used to assess pain intensity in participant children and included two separate scales. 6 photographs were assigned scores of 0, 20, 40, 60, 80, and 100 (in increasing increments of pain), such that these would be the scores averaged for participants unable to count by number. Children able to count to 100 by ones or tens and who could identify the larger of 2 numbers used the second scale; a vertical numeric one (0–100) that was printed next to the faces."|Before the application of Liposomal Lidocaine and immediately after Pin Perc removal, approximately 30 minutes|||units on a scale||Standard Deviation|Mean
682413|NCT01542034|Secondary|Change From Baseline in Patient-Reported Submental Fat Impact Scale (PR-SMFIS)|The PR-SMFIS assesses the impact of submental fat on self-perception of 6 emotional and visual characteristics related to the appearance of submental fullness (unhappy, bothered, self-conscious, embarrassed, look older, and look overweight) as evaluated by the participant. Each item is rated on an 11-point numeric scale from 0 to 10. Scores for the 6 items were averaged to generate a PR-SMFIS total scale score ranging from 0 to 10 where 0 is a positive outcome and 10 is a negative outcome. A negative change from Baseline indicates improvement.|Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)|Intent-to-treat population; missing values were imputed using a multiple imputation process.||units on a scale||Standard Deviation|Mean
682441|NCT01541865|Secondary|Cerebrovascular Accident (CVA) at Time of Procedure||Duration of the procedure (average of 65 minutes)|||participants|||Number
682414|NCT01542034|Secondary|Percentage of Participants With a Magnetic Resonance Imaging (MRI) Response|An MRI responder is a participant who exhibited at least a 10% reduction in submental fat volume as measured by MRI from Baseline to 12 weeks after last treatment. Magnetic resonance imaging was evaluated in a subset of participants at selected centers.|Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)|The ITT-MRI population consisted of all randomized participants who participated in the MRI cohort and had evaluable Baseline MRI data. A multiple imputation process was used.||percentage of participants|||Number
682415|NCT01542034|Primary|Percentage of Participants Who Achieved a Composite 2-grade Response|"A composite 2-grade response is defined as at least a 2-grade improvement from Baseline on both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) 12 weeks after the last treatment.
The CR-SMFRS score is based on the investigator’s clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0–4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.
The PR-SMFRS is based on the participant's response to the question How much fat do you have under your chin right now? answered on a 5-point ordinal scale (0–4) with 0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat."|Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)|Intent-to-treat population; missing values were imputed using a multiple imputation process.||percentage of participants|||Number
682416|NCT01542034|Primary|Percentage of Participants Who Achieved a Composite 1-grade Response|"A composite 1-grade response is defined as at least a 1-grade improvement from Baseline on both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) 12 weeks after the last treatment.
The CR-SMFRS score is based on the investigator’s clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0–4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.
The PR-SMFRS is based on the participant's response to the question How much fat do you have under your chin right now? answered on a 5-point ordinal scale (0–4) with 0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat."|Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)|Intent-to-treat (ITT) population; missing values were imputed using a multiple imputation process.||percentage of participants|||Number
682417|NCT01541969|Secondary|Tinnitus Handicap Questionnaire (THQ)|Change in the global score on a 27 item, multi-attribute questionnaire measure of the functional impact of tinnitus (0-100 scale). Change was computed as 'visit 2' - 'visit 10' and so a positive change score indicates a reduction of tinnitus symptoms.|Baseline (visit 2) and 36 weeks (visit 10)|We have analyzed both complete case and multiple imputed data for the mean change in global THQ score from baseline (visit 2) to 36 weeks (visit 10). Here we report complete case data.||units on a scale||Standard Deviation|Mean
682418|NCT01541969|Secondary|Percent Change From Baseline in Normalized Oscillatory Power in the Delta Brainwave Pattern as Measured by Electroencephalography (EEG)|"Non-invasive recording to measure rhythmic patterns of spontaneous brain activity at rest. An a priori hypothesis targeted normalized delta rhythm. Band powers were calculated as percent change in delta brainwave pattern relative to change in total (1-90 Hz) EEG band. Comparison made between 'visit 2' and 'visit 6'.
We used a Neuroscan system (SynAmps2 model 8050, Compumedics Neuroscan, Charlotte, NC, USA) and custom cap with 66 equidistant scalp electrodes (Easycap, GmbH, Germany). A central frontal electrode was used as ground and a nose-tip electrode as reference. Electrode impedances were maintained at 5 kΩ prior to recordings. Recording was done with an offline filter of 0.5 to 200 Hz pass-band and 1 kHz sampling rate. Recording was over a continuous 10-minute period. Participants were seated in a quiet, darkened soundproof booth and were instructed to relax, keep eyes open and fix gaze on a marker point."|Baseline (visit 2) and 12 weeks (visit 6)|The EEG assessment was offered only to the first 50 participants enrolled at the Nottingham site. We have analyzed only complete case data for the mean change in delta band power from baseline (visit 2) to 12 weeks (visit 6).||Percent change||Standard Deviation|Mean
682419|NCT01541969|Secondary|World Health Organization Quality of Life Questionnaire (WHOQOL-BREF)|The WHOQOL-BREF is a 26-item, multi-attribute questionnaire measure of health related quality of life. Outcome was measured as a change on Question 1: 'How would you rate your quality of life (over the past 4 weeks)?' There are 5 response options (Very poor=1; Poor=2; Neither poor nor good=3; Good=4; Very good=5). Change was computed as 'visit 2' - 'visit 6' and so a positive change score indicates a reduction in self-perceived quality of life.|Baseline (visit 2) and 12 weeks (visit 6)|We have analyzed both complete case and multiple imputed data for the mean change in Q1 score from baseline (visit 2) to 12 weeks (visit 6). Here we report complete case data.||units on a scale||Standard Deviation|Mean
682420|NCT01541969|Secondary|Tinnitus Functional Index (TFI)|Change in the global score on a 25 item, multi-attribute questionnaire measure of the functional impact of tinnitus (0-100 scale). Change was computed as 'visit 2' - 'visit 6' and so a positive change score indicates a reduction of tinnitus symptoms.|Baseline (visit 2) and 12 weeks (visit 6)|We have analyzed both complete case and multiple imputed data for the mean change in global TFI score from baseline (visit 2) to 12 weeks (visit 6). Here we report complete case data.||units on a scale||Standard Deviation|Mean
682421|NCT01541969|Secondary|Tinnitus Handicap Inventory (THI)|Change in the global score on a 25 item, multi-attribute questionnaire measure of the functional impact of tinnitus (0-100 scale). Change was computed as 'visit 2' - 'visit 6' and so a positive change score indicates a reduction of tinnitus symptoms.|Baseline (visit 2) and 12 weeks (visit 6)|We have analyzed both complete case and multiple imputed data for the mean change in global THI score from baseline (visit 2) to 12 weeks (visit 6). Here we report complete case data.||units on a scale||Standard Deviation|Mean
682422|NCT01541969|Primary|Tinnitus Handicap Questionnaire (THQ)|Change in the global score on a 27 item, multi-attribute questionnaire measure of the functional impact of tinnitus (0-100 scale). Change was computed as 'visit 2' - 'visit 6' and so a positive change score indicates a reduction of tinnitus symptoms.|Baseline (visit 2) and 12 weeks (visit 6)|We have analyzed both complete case and multiple imputed data for the mean change in global THQ score from baseline (visit 2) to 12 weeks (visit 6). Here we report complete case data.||units on a scale||Standard Deviation|Mean
682442|NCT01541865|Secondary|Renal Artery Infarction or Embolus||Duration of the procedure (average of 65 minutes)|||participants|||Number
682423|NCT01541930|Secondary|Pain (Visual Analogue Scale)|The pain linked to the fungating tumour over the last 24 hours was evaluated by the patient. The pain was graded using a 100 mm linear visual analogical scale (graded from 0 mm = no pain to 100 mm = severe pain).|on Days 0 (baseline), 7, and 14|All patients who received the treatment at least once (Safety population) were included in all efficacy and safety analyses.||mm||Standard Deviation|Mean
682424|NCT01541930|Secondary|Appearance (Volume and Nature of Discharge at Cutaneous Ulcer)|Appearance score was evaluated by the Study Investigator using the following scale; 0: None (No discharge, e.g. frequency of dressing change: once daily), 1: Mild (Dressing need to be Changed twice daily), 2: Moderate (Dressing need to be Changed 3 times daily), 3: Marked (Dressing need to be Changed >3 times daily / Bloody).|on Days 0 (baseline), 7, and 14|All patients who received the treatment at least once (Safety population) were included in all efficacy and safety analyses.||participants|||Number
682425|NCT01541930|Secondary|Smell Score by Patient|Tumour smell score was evaluated by the Patient using the following scale; 0: No smell, 1: Smell present but not offensive, 2: Mildly offensive smell,3: Moderately offensive smell, 4: Extremely offensive smell|on Days 0 (baseline), 7, and 14|All patients who received the treatment at least once (Safety population) were included in all efficacy and safety analyses.||participants|||Number
682426|NCT01541930|Secondary|Smell Score by Nurse|Tumour smell score was evaluated by the Nurse using the following scale; 0: No smell, 1: Smell present but not offensive, 2: Mildly offensive smell,3: Moderately offensive smell, 4: Extremely offensive smell|on Days 0 (baseline), 7, and 14|All patients who received the treatment at least once (Safety population) were included in all efficacy and safety analyses.||participants|||Number
682427|NCT01541930|Secondary|Smell Score by Investigator|Tumour smell score was evaluated by the Study Investigator using the following scale; 0: No smell, 1: Smell present but not offensive, 2: Mildly offensive smell, 3: Moderately offensive smell, 4: Extremely offensive smell|on Days 0 (baseline), 7, and 14|All patients who received the treatment at least once (Safety population) were included in all efficacy and safety analyses.||participants|||Number
682428|NCT01541930|Primary|The Success Rate|The success rate, where success for a patient is defined as a smell score of 0 or 1 (0: No smell, 1: Smell present but not offensive) as assessed by the Study Investigator|at Day 14 (end of treatment)|All patients who received the treatment at least once (Safety population) were included in all efficacy and safety analyses. Only observed cases were part of the analyses. If the primary endpoint was missing, an additional analysis of this endpoint was performed using the last observation carried forward (LOCF) to impute the missing data.||percentage of participants||90% Confidence Interval|Number
682429|NCT01541917|Secondary|Change in Approach Coping|"Scores on the Approach Coping sub-scale of the Pain Coping Questionnaire were used to measure approach coping, which is a type of coping considered to be adaptive and helpful for pain. Responses to items on this subscale are on a 5-point scale (never use to very often use) and are averaged together for the subscale score, such that scores range from a worst possible value of 1 to a best possible value of 5."|Pre-intervention, post-intervention, 6-month follow-up, 12-month follow-up|||units on a scale||Standard Deviation|Mean
682430|NCT01541917|Secondary|Change in Children’s Arthritis Self-Efficacy (CASE) Scores|"Confidence in managing arthritis was measured by patient self-report using an electronic version of the Children's Arthritis Self-Efficacy (CASE) scale. Responses on a 5-point scale (not at all sure to very sure) are averaged together to form a total score, with 0 being the worst possible value and 5 being the best possible value."|Pre-intervention, post-intervention, 6-month follow-up, 12-month follow-up|||units on a scale||Standard Deviation|Mean
682431|NCT01541917|Secondary|Change in Disease Activity|Disease activity was assessed by the treating physician based on a complete joint count (count of the number of joints that are swollen, painful, tender, or restriction in motion). The lowest (best) value is 0, and the highest (worst) possible value is 300.|Pre-intervention, post-intervention, 6-month follow-up, 12-month follow-up|||joints||Standard Deviation|Mean
682432|NCT01541917|Secondary|Change in Medical Issues, Exercise, Pain and Social Support Questionnaire (MEPS) Education Score|Knowledge about Juvenile Idiopathic Arthritis was measured by patient self-report using an electronic version of the Medical Issues, Exercise, Pain and Social support (MEPS) Questionnaire. Responses on this scale are measured on a 0-10 numeric rating scale and averaged together to form a summary score, with 0 being the worst possible score and 10 being the best possible score.|Pre-intervention, post-intervention, 6-month follow-up, 12-month follow-up|||units on a scale||Standard Deviation|Mean
682433|NCT01541917|Primary|Change in PedsQL Rheumatology Health-Related Quality of Life Total Score|Health-related quality of life was measured by patient self-report using an electronic version of the PedsQL Rheumatology Module. Responses on this scale are transformed into a 0-100 scale, with 0 being the worst value for health-related quality of life and 100 being the best possible value for health-related quality of life.|Pre-intervention, post-intervention, 6-month follow-up, 12-month follow-up|||units on a scale||Standard Deviation|Mean
682434|NCT01541917|Primary|Change in Pain Intensity|"Pain intensity was assessed by patient-self report using an electronic numeric rating scale ranging from 0-10, with 0 being the lowest value (no pain) and 10 being the highest value (very much pain)."|Baseline, post-treatment, 6-month follow-up, 12-month follow-up|All randomized patients were analyzed regardless of whether or not they completed treatment (intent to treat analyses).||Units on a scale||Standard Deviation|Mean
682435|NCT01541865|Secondary|Reduction in Estimated Glomerular Filtration Rate (eGFR) >25%||2 Years|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 25 participants were not evaluable.||participants|||Number
682436|NCT01541865|Secondary|Hypertensive Emergency Necessitating Hospital Admission (Unrelated to Medication and/or Non-compliance)||2 Years|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 22 participants were not evaluable.||participants|||Number
682437|NCT01541865|Secondary|Chronic Symptomatic Orthostatic Hypotension||2 Years|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 22 participants were not evaluable.||participants|||Number
682438|NCT01541865|Secondary|Angiographically-documented Renal Stenosis Requiring an Intervention||2 Years|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 22 participants were not evaluable.||participants|||Number
682444|NCT01541865|Primary|Change in Systolic and Diastolic Blood Pressure at Six (6) Months as Measured by 24-hour Ambulatory Blood Pressure|Change in systolic and diastolic blood pressure at six (6) months as measured by 24-hour ambulatory blood pressure monitoring (ABPM) following therapeutic renal denervation compared to baseline using a validated ABPM device.|Baseline and 6 months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 76 participants were not evaluable at either the baseline or 6 month assessment.||mm Hg||Standard Deviation|Mean
682445|NCT01541865|Secondary|Absence of Flow Limiting Stenosis in the Renal Artery|Absence of flow limiting stenosis in the renal artery at six (6) months follow up time point as measured by renal duplex ultrasound|6 months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 3 participants were not evaluable.||participants w/o flow limiting stenosis|||Number
682446|NCT01541865|Primary|Change in Systolic and Diastolic Blood Pressure at Six (6) Months as Measured by Office-based Blood Pressure Assessment|Change in systolic and diastolic blood pressure at six (6) months as measured by office-based blood pressure assessment following therapeutic renal denervation compared to baseline. Office blood pressure will be measured using a validated electronic device according to a standardized procedure. .|Baseline and 6 months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 3 participants were not evaluable.||mm Hg||Standard Deviation|Mean
682447|NCT01541826|Secondary|Energy-adjusted Vitamin A Intake|Energy-adjusted vitamin A intake from 3-day dietary recalls at baseline and 12 weeks. Values reported as the average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 12 weeks|"Survey data were not available for two participants in the Color-matched rice powder pill group. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose."||retinol equivalent mcg/day||Standard Error|Mean
682448|NCT01541826|Secondary|Intake of Dietary Antioxidant Capacity|Energy-adjusted intake of dietary antioxidant capacity determined by 3-day dietary recalls at baseline and 12 weeks. Values reported as average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 12 weeks|"Survey data were not available for two participants in the Color-matched rice powder pill group. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose."||Vitamin C equivalents||Standard Error|Mean
682449|NCT01541826|Secondary|Polyphenol Intake|Energy-adjusted polyphenol intake assessed by 3-day dietary recalls at baseline and 12 weeks, values determined by average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 12 weeks|"Survey data were not available for two participants in the Color-matched rice powder pill group. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose."||mg/day||Standard Error|Mean
682450|NCT01541826|Secondary|Energy-adjusted Micronutrient Intake|Energy-adjusted micronutrient intake from 3-day dietary recalls at baseline and 12 weeks. Values reported as the average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 12 weeks|"Survey data were not available for two participants in the Color-matched rice powder pill group. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose."||mg/day||Standard Error|Mean
682451|NCT01541826|Secondary|Energy Intake|Energy intake reported from 3-day dietary recalls at baseline and 12 weeks, determined by the average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 12 weeks|"Survey data were not available for two participants in the Color-matched rice powder pill group. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose."||kcal/d||Standard Error|Mean
682452|NCT01541826|Secondary|Energy-adjusted Nutrient Intake: Carbohydrate, Protein, Fat, Fiber|Energy-adjusted intake based on 3-day dietary recalls, determined by the average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 12 weeks|"Survey data were not available for two participants in the Color-matched rice powder pill group. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose."||g/day||Standard Error|Mean
682453|NCT01541826|Secondary|Urinary Polyphenol Excretion|Overnight urinary polyphenol excretion after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|12 weeks|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.||mg/mg creatinine||Inter-Quartile Range|Median
682454|NCT01541826|Secondary|Superoxide Dismutase Activity|Fasting plasma superoxide dismutase after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 6 weeks, 12 weeks|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.||units/mL||Standard Error|Mean
682455|NCT01541826|Secondary|Glutathione Peroxidase Activity|Fasting plasma glutathione peroxidase activity after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 6 weeks, 12 weeks|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.||nmol/min/mL||Standard Error|Mean
682456|NCT01541826|Secondary|Catalase Activity|Catalase activity after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 6 weeks, 12 weeks|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.||nmol/min/mL||Standard Error|Mean
682457|NCT01541826|Secondary|Total Antioxidant Capacity|Fasting plasma total antioxidant capacity after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 6 weeks, 12 weeks|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.||micrograms vitamin C equivalents/mL||Standard Error|Mean
682458|NCT01541826|Secondary|P-selectin|Fasting plasma P-selectin after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 6 weeks, 12 weeks|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.||ng/mL||Standard Error|Mean
682459|NCT01541826|Secondary|Soluble Vascular Cell Adhesion Molecule 1|Fasting plasma soluble vascular cell adhesion molecule 1 after chronic consumption. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 6 weeks, 12 weeks|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.||ng/mL||Standard Deviation|Mean
682462|NCT01541826|Secondary|Tumor Necrosis Factor-alpha|Fasting plasma Tumor necrosis factor-alpha after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 6 weeks, 12 weeks|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.||pg/mL||Standard Error|Mean
682463|NCT01541826|Secondary|Monocyte Chemoattractant Protein-1|Fasting plasma monocyte chemoattractant protein-1 after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 6 weeks, 12 weeks|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.||pg/mL||Standard Error|Mean
682464|NCT01541826|Secondary|Interleukin-6|Fasting plasma interleukin-6 after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 6 weeks, 12 weeks|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.||pg/mL||Standard Error|Mean
682465|NCT01541826|Secondary|Interleukin-1 Beta|Fasting plasma interleukin-1 beta after chronic consumption. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 6 weeks, 12 weeks|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.||pg/mL||Standard Error|Mean
682466|NCT01541826|Secondary|Adiponectin|Fasting plasma adiponectin after chronic consumption. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 6 weeks, 12 weeks|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.||micrograms/mL||Standard Error|Mean
682467|NCT01541826|Secondary|Urinary Excretion of Polyphenols|Urinary excretion of polyphenols, from 0 to 24 h after consumption of extract, area under the curve (AUC) in Chokeberry Extract Capsule (acute) arm only.|0 to 24 h after consumption of extract|Not determined in chronic arms (Color-matched Rice Powder Pill or Chokeberry Extract Capsule) as this analysis required additional collection time-points that were not utilized in the other arms.||mg x h/mg creatinine||Standard Error|Mean
682468|NCT01541826|Secondary|Plasma Area Under the Curve of Chokeberry Polyphenols and Their Metabolites.|Plasma area under the curve of chokeberry polyphenols and their metabolites. Measurement (time 0) began at study baseline. Not determined in chronic arms (Color-matched Rice Powder Pill or Chokeberry Extract Capsule).|0, 0.5, 1, 2, 4, 6, 9, 12, and 24 hours following dose|Not determined in chronic arms (Color-matched Rice Powder Pill or Chokeberry Extract Capsule) as this analysis required additional collection time-points that were not utilized in the other arms.||micrograms x h/mL||Standard Error|Mean
682469|NCT01541826|Secondary|LDL Receptor (LDLR) Protein|Monocyte LDL receptor protein by Western blot, normalized to β-actin after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 12 weeks|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.||relative expression (LDLR/β-actin)||Standard Error|Mean
682470|NCT01541826|Secondary|LDL Receptor (LDLR)|Monocyte LDL receptor mRNA normalized to glyceraldehyde-3-phosphate dehydrogenase after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Change from baseline at 12 weeks|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.||relative expression (LDLR/GAPDH)||Standard Error|Mean
682471|NCT01541826|Secondary|3-hydroxy-3-methyl-glutaryl Coenzyme A Reductase (HMGR)|Monocyte messenger ribonucleic acid (mRNA) expression normalized to glyceraldehyde-3-phosphate dehydrogenase (GAPDH) after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 12 wk|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.||relative expression (HMGR/GAPDH)||Standard Error|Mean
682472|NCT01541826|Secondary|Urinary F2-isoprostanes|Change in resting urinary F2-isoprostanes after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline and 12 weeks following intervention|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.||ng/mmol creatinine||Standard Error|Mean
682473|NCT01541826|Secondary|Resting Diastolic Blood Pressure|Change in resting diastolic blood pressure after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 6 weeks, and 12 weeks following intervention|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.||mmHg||Standard Error|Mean
682474|NCT01541826|Secondary|Resting Systolic Blood Pressure|Change in resting systolic blood pressure after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 6 weeks, and 12 weeks following intervention|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.||mmHg||Standard Error|Mean
682475|NCT01541826|Secondary|Triglycerides|Change in fasting plasma triglycerides from baseline after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|6 and 12 weeks after supplementation|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.||mg/dL||Standard Error|Mean
682476|NCT01541826|Secondary|HDL-cholesterol|Change in fasting plasma cholesterol from baseline after chronic supplemenation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|6 and 12 weeks after supplementation|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.||mg/dL||Standard Error|Mean
682477|NCT01541826|Secondary|Total Cholesterol|Change in fasting total cholesterol from baseline after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|6 and 12 weeks after supplementation|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.||mg/dL||Standard Error|Mean
682478|NCT01541826|Primary|LDL Cholesterol|Change in LDL cholesterol from baseline after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 6 weeks, 12 weeks of intervention|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.||mg/dL||Standard Error|Mean
682479|NCT01541735|Primary|Total Insulin Secretion|The hyperglycemic-hyperinsulinemic clamp technique is performed to assess the total insulin secretion|Change from baseline of total insulin secretion at 45 day (plus or minus 3 days)|||µU/ml||Standard Deviation|Mean
682480|NCT01541735|Primary|Second Phase of Insulin Secretion|Change from baseline in first phase insulin secretion at 45 day. (plus or minus 3 days)|Baseline and 45 day|||µU/ml||Standard Deviation|Mean
682481|NCT01541735|Secondary|Glycated Hemoglobin A1C||Change from Baseline in glycated hemoglobin A1C at 45 day.|||percentage||Standard Deviation|Mean
682482|NCT01541735|Primary|First Phase of Insulin Secretion|The hyperglycemic-hyperinsulinemic clamp technique is perform to assess the phases of insulin secretion: first, late and total insulin secretion.|Change from Baseline at 45 days. (plus or minus 3 days)|The analysis was determined per protocol and sample size was calculated whit the formula for clinical trial||µU/ml||Standard Deviation|Mean
682483|NCT01541644|Primary|To Determine the Response Rate (Via FACT/GOG-Ntx Scores) Effectiveness and Safety of Acupuncture in Alleviating Neuropathic Symptoms When Treating Patients With Moderate to Severe Bortezomib-induced Peripheral Neuropathy (BIPN)|The Neuropathic Pain Scale (NPS) uses self-report visual analogue scales (VAS) to quantify on a scale of 0-10 (with total NPS score of 1-100), global pain intensity and unpleasantness and 8 other descriptive qualities of neuropathic pain. Response defined as average change of Clinical Total Neuropathy Score (TNSc) greater than or equal to 10% over 10 weeks compared to baseline. Effect defined as as average change of Functional Assessment of Cancer Therapy-Neurotoxicity/ Gynecologic Oncology Group (FACT/GOG-Ntx)over 10 weeks as compared to baseline. Safety will be assessed by recording side effects from acupuncture treatment. Please note TNSc results deemed invalid as original validation of TNSc was performed by 2 neuromuscular trained physicians & the TNSc in our trial was performed by a research nurse. The reliability & validity of research nurse's TNSc not established pre-trial. For the scale range, the higher the score the worse the symptoms and function. No subscales were used.|Baseline and 10 weeks|||units on a scale (1 - 100)||Standard Deviation|Mean
682484|NCT01541553|Secondary|Partial Clearance of AKs at Week 11|Partial clearance of AKs at Week 11, defined as 75% or greater reduction from baseline in the number of clinically visible AKs in the selected treatment area at Week 11|Week 11|||participants|||Number
682485|NCT01541553|Secondary|Percentage Change From Baseline in Number of AKs at Week 11|Percentage change from baseline in number of AKs at Week 11|Baseline to week 11|||percentage of change||Standard Deviation|Mean
682486|NCT01541553|Primary|Complete Clearance of AKs at Week 11|To determine the 11-week rate of complete clearance of AKs (defined as no clinically visible AKs) in the selected treatment area using sequential cryotherapy and field treatment with PEP005 Gel compared to cryotherapy alone.|11 weeks|||participants|||Number
682487|NCT01541397|Secondary|Plasma Phenylalanine Levels|Plasma phenylalanine levels will be monitored to determine effectiveness of Kuvan therapy.|weekly for 6 weeks, then at least every three months up to 1 year|Zero participants were analyzed because the study was ended early (due to an insufficient number of enrolled participants).|||||
682488|NCT01541397|Secondary|Diet Analysis|Subjects will provide a 3 day diet record for every plasma amino acid evaluation. Diets will be analyzed to determine phenylalanine, protein, calories, fat, vitamins and minerals.|every 3 months up to 1 year|Zero participants were analyzed because the study was ended early (due to an insufficient number of enrolled participants).|||||
682489|NCT01541397|Secondary|Plasma Amino Acid Profile|Evaluation of levels of plasma amino acids.|every three months up to 1 year|Zero participants were analyzed because the study was ended early (due to an insufficient number of enrolled participants).|||||
682490|NCT01541397|Primary|Bone Mineral Density|A DXA scan will be conducted one year after Kuvan therapy is initiated.|1 year after initiation of Kuvan therapy|Zero participants were analyzed because the study was ended early (due to an insufficient number of enrolled participants).|||||
682491|NCT01541384|Primary|Immunosuppression (Tacrolimus) Adherence|"The primary outcome will be the percentage of tacrolimus doses taken as directed during the final 90 days of this 180 day trial as measured by the GlowCap. This includes a 14 day wash-in period for device acclimatization."|90 days|||percentage of correct tacrolimus doses||Standard Deviation|Mean
682492|NCT01541371|Secondary|Change From Baseline in Sleep and Daytime Drowsiness Evaluation Score at Week 12|The self-administered sleep VAS scale (0-100 milimeter [mm]) rates quality of sleep (QoS) and daytime drowsiness (DD). Participants indicate mark on the scale to represent how well they have slept in the previous 7 days, score ranges from 0 mm (very badly) to 100 mm (very well); and how often they have felt drowsy within the previous 7 days, from 0 mm (not at all) to 100 mm (all the time).|Baseline and Week 12|"FAS included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy measurement. Here N (Number of Participants Analyzed): number of participants who were evaluable for this measure. ‘n’: number of participants who were evaluable at given time point for each arm group, respectively."||mm||Standard Deviation|Mean
682493|NCT01541371|Secondary|Number of Participants With Satisfaction With the Study Treatment|Participants assessed their satisfaction with paliperidone ER on a 5-point scale: 1 (very good), 2 (good), 3 (moderate), 4 (poor) and 5 (very poor).|Baseline and Week 12|"FAS included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy measurement. Here N (Number of Participants Analyzed): number of participants who were evaluable for this measure. ‘n’: number of participants who were evaluable at given time point for each arm group, respectively."||Participants|||Number
682494|NCT01541371|Secondary|Change From Baseline in Total Personal and Social Performance (PSP) Score at Week 12|PSP assesses the degree of a participant’s dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Based on the four domains there will be one total score. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; =<30, functioning so poorly as to require intensive supervision.|Baseline and Week 12|FAS included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy measurement. Here ‘n’: number of participants who were evaluable at given time point for each arm group, respectively.||Units on a scale||Standard Deviation|Mean
682495|NCT01541371|Secondary|Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 12|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to normal, not at all ill and a rating of 7 is equivalent to among the most extremely ill participants. Higher change scores indicate worsening."|Baseline and Week 12|"FAS included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy measurement. Here N (Number of Participants Analyzed): number of participants who were evaluable for this measure. ‘n’: number of participants who were evaluable at given time point for each arm group, respectively."||units on a scale||Standard Deviation|Mean
682496|NCT01541371|Secondary|Percentage of Participants With Response to Positive and Negative Syndrome Scale (PANSS) Total Score|PANSS is a medical scale that assesses various symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill). Percentage of participants with at least 20 percent improvement of PANSS total score was measured.|Week 12|FAS included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy measurement.||Percentage of participants||95% Confidence Interval|Number
682497|NCT01541371|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Week 12|The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). Positive symptoms subscale consists of 8 items with total score range of 8-56; negative symptoms subscale and disorganized thoughts subscale, each consists of 7 items with total score range of 7-49, uncontrolled hostility/excitement subscale and anxiety/depression subscale, each consists of 4 items with total score range of 4-28. Higher change score indicates greater severity.|Baseline and Week 12|FAS included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy measurement.||Units on a scale||Standard Deviation|Mean
682498|NCT01541371|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Subscale Scores at Week 12|PANSS is a medical scale that assesses various symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill). Positive syndrome subscale ranges from 7 to 49, higher change scores indicate worsening. Negative syndrome subscale ranges from 7 to 49, higher change scores indicate worsening. General Psychopathology subscale ranges from 16 to112, higher change scores indicate worsening.|Baseline and Week 12|FAS included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy measurement.||Units on a scale||Standard Deviation|Mean
682499|NCT01541371|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 12|PANSS is a medical scale that assesses various symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions [a false belief held in the face of strong differing evidence, especially as a symptom of psychiatric disorder] and hallucinations [imagining things], and withdrawal into the self). The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill).|Baseline and Week 12|Full analysis set (FAS) included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy measurement.||unit on a scale||Standard Deviation|Mean
682500|NCT01541358|Secondary|Sensitivity of F-18 NaF PET/CT to Detect Bone Lesions in Patients With Suspected Skeletal Malignancy|"Sensitivity is the ability of a test to correctly identify those with the disease (true positive rate). This study determined how many lesions were detected by F18 NaF PET/CT compared to the known results. The calculation for sensitivity is TP / (TP+FN), where:
TP = true positive (the lesion was accurately detected on both F18 NaF and comparison study) FN = false negative (the lesion was not detected on the PET/CT but was detected on the comparison study)
The result is expressed as the percentage of confirmed lesions across all participants that were also detected by F18 NaF PET/CT."|an estimated average of 2 hours|Both participants were included in the analysis.||percentage of sensitivity|||Number
682501|NCT01541358|Secondary|Specificity of F-18 NaF PET/CT to Detect Bone Lesions in Patients With Suspected Skeletal Malignancy|"Specificity is the ability of a test to correctly determine the absence of disease (true negative). This study determined how accurately F18 NaF PET/CT performed at detecting the absence of disease.
The calculation for specificity is TN / (TN + FP), where:
TN = the participant was a true negative (the lesion was not detected on F18 NaF PET/CT and the patient does not have the disease) FP = the participant was a false positive (the lesion was falsely detected on the F18 NaF PET/CT and the patient does not have the disease) The result is expressed as a percentage."|an estimated average of 2 hours|Both participants were included in the analysis.||percentage of specificity|||Number
682502|NCT01541358|Primary|Total Number of Lesions Identified by F-18 NaF PET/CT in Patients With Suspected Skeletal Malignancy|F-18 NaF is a positron emission tomography (PET) bone imaging agent that targets changes in the bone. The fluoride ions are taken up in areas of the bone that have increased bone remodeling (bone repair) and increased blood flow, which is indicative of diseases such as cancer.|an estimated average of 2 hours|Includes all study participants.||lesions detected by F18 NaF|||Number
682503|NCT01541254|Secondary|Unplanned Embolization Coiling Within 6 Months|If the target lesion(aneurysm)treated needed further embolization within 6 months of initial treatment(detected during follow up or unscheduled visit ),data will be recorded and analyzed.|Day 1-6 months||||||
682504|NCT01541254|Secondary|Device and Procedure Related Serious Adverse Events|All Serious Adverse events will be reported per protocol|Day 1-6months(± 4 months)||||||
682505|NCT01541254|Secondary|Stent Migration at 6 Months|Angiographic images will be comparing post procedure sent position to 6 months|6 months||||||
682506|NCT01541254|Secondary|Significant Stenosis(>50%) of the Treated Artery at 6 Months|Parent Artery will be measured baseline and compared at 6 months post procedure per review by the Independent Core Lab.|6 months||||||
682507|NCT01541254|Secondary|Successful Delivery of the LVIS™ Device Measures by Technical Success|Technical success being defined as: access to the lesion, successful deployment of the LVIS™ device.|24 hours||||||
682508|NCT01541254|Secondary|Parent Artery Patency Measured Angiographically at 6 Months|To be assessed by Independent Core Lab.|6 months||||||
682509|NCT01541254|Primary|Safety Measures as Any Major Stroke or Death Within 30 Days, or Major Ipsi-lateral Stroke or Neurological Death Within 6 Months|A major stroke is defined as a new neurological event that persists for >24 hours and results in a ≥ 4 point increase in the National Institutes of Health Stroke Scale (NIHSS) score compared to baseline or compared to any subsequent lower score.|30 days-6 months|||patients|||Number
682510|NCT01541254|Primary|Probable Benefit Measures as Successful Aneurysm Treatment With the LVIS™ Device, as Measured by Aneurysm Angiographic Occlusion of ≥ 90% at 6 Months (± 4 Weeks)|Imaging from each subject to be reviewed by an independent core lab who will be comparing with baseline and post procedure images.|6 months ± 4 weeks|||percent occlusion of aneurysm||Standard Deviation|Mean
682512|NCT01540981|Primary|Effectiveness|"To compare between the treatment groups the effect of the assigned study treatment on the rate of progression of DTI to advanced stage pressure ulcer (Stage III or greater, continued DTI, or a pressure ulcer that is unable to be staged due to necrotic tissue).
Stage I - Intact skin with non-blanchable redness of a localized area Stage II - Partial thickness loss of dermis Stage III - Full thickness loss, subcutaneous fat may be visible Stage IV - Full thickness tissue loss with exposed bone, tendon or muscle Unstageable - Full thickness tissue loss in which the base of the ulcer is covered by slough or eschar Continues deep tissue injury - purple or maroon localize area of discolored intact skin that may be mushy or boggy"|14 days|||participants|||Number
682513|NCT01540851|Secondary|Range of Motion|Percentage of participants able to bend knee at least 120 degrees|6 months after TKA|Percentage of participants who self-reported on their 6 month questionnaire that they were able to bend their index knee to greater than 120 degrees||percentage of participants|||Number
682514|NCT01540851|Secondary|Satisfaction|Percentage of patients in each study arm who reported being very satisfied with the results of TKA|Measured at 6 months post TKA|The proportion of participants who reported being very satisfied with the results of TKA was assessed using a 5-item Likert scale on the 6 month follow-up questionnaire||percentage of participants|||Number
682515|NCT01540851|Primary|Change in WOMAC Physical Function|The change in functional status will be measured using the WOMAC Physical Function scale at Baseline and 6 months|Change in functional status from baseline to 6 months|The WOMAC Physical Function scale is scaled from 0 to 100, with 100 worst. Change in function was calculated as the WOMAC Physical Function score at 6 months minus the WOMAC Physical Function score at baseline||units on a scale||95% Confidence Interval|Mean
682516|NCT01540825|Primary|Assessment of Tolerability by the Investigator|Assessment of tolerability by the investigator assessed according to the categories good, satisfactory, not satisfactory, bad and not assessable.|End of study visit, up to day 10|Treated set||Percentage of participants|||Number
682517|NCT01540825|Primary|Percentage of Participants With Drug-related Adverse Events|Percentage of participants with drug-related adverse events|From administration of study drug until end-of-study visit, up to 10 days|Treated set||Percentage of participants|||Number
682518|NCT01540825|Secondary|t1/2|Terminal half-life of the analyte in plasma (t1/2)|Before drug administration and 15minutes (min), 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 34h, 48h and 72h (for doses >=50mg only) after drug administration|PK set||Hours||Geometric Coefficient of Variation|Geometric Mean
682519|NCT01540825|Secondary|AUC0-infinity|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity)|Before drug administration and 15minutes (min), 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 34h, 48h and 72h (for doses >=50mg only) after drug administration|PK set||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
682520|NCT01540825|Secondary|AUC0-tz|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz)|Before drug administration and 15minutes (min), 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 34h, 48h and 72h (for doses >=50mg only) after drug administration|PK set||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
682521|NCT01540825|Secondary|Tmax|Time from dosing to maximum measured concentration of the analyte in plasma (Tmax)|Before drug administration and 15minutes (min), 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 34h, 48h and 72h (for doses >=50mg only) after drug administration|PK set||Hours||Full Range|Median
682522|NCT01540825|Secondary|Cmax|"Maximum measured concentration of the analyte in plasma (Cmax).
The analysis population was the pharmacokinetic (PK) set which included all subjects randomised and treated with study medication who provided at least 1 evaluable observation for a PK endpoint of Area Under the Concentration-time Curve from 0 to infinity (AUC0-inf), Area Under the Concentration-time Curve from 0 to the last quantifiable data point (AUC0-tz) and Cmax and who had no important protocol violations relevant to the evaluation of PK."|Before drug administration and 15minutes (min), 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 34h, 48h and 72h (for doses >=50mg only) after drug administration|PK set||nmol/L||Geometric Coefficient of Variation|Geometric Mean
682523|NCT01540825|Primary|Clinically Relevant Abnormalities for Clinical Laboratory Evaluation, Vital Signs, Lung Function, Carbon Monoxide Diffusing Capacity of the Lung, ECG, Physical Examination, Orthostasis Test, Oxygen Saturation or Haemoccult Test|Clinically relevant abnormalities for clinical laboratory evaluation, vital signs, lung function, carbon monoxide Diffusing Capacity Of the Lung (DLCO), Electrocardiogram (ECG), physical examination, orthostasis test, oxygen saturation or haemoccult test|From administration of study drug until end-of-study visit, up to 10 days|Treated set||Percentage of participants|||Number
682524|NCT01540773|Secondary|Insulin-like Growth Factor 1|Measure IGF-1 eight hours following the administration of the capsules containing the proprietary amino acid derivative blend or placebos.|8 hours following adminstration|||min*ng/mL||95% Confidence Interval|Mean
682525|NCT01540773|Primary|Area Under the Curve of Growth Hormone Over Baseline|Measure human growth hormone at times 0-120 minutes on two occasions about one week apart. On one occasion, the proprietary amino acid derivative blend will be given orally at time 0 in capsule form, and on the other occasion the capsules will contain no amino acids.|0-120 minutes, at Baseline and post dose, week 1 and week 3|||min*ng/mL||95% Confidence Interval|Mean
682526|NCT01540773|Primary|Percent Change of Growth Hormone Over Baseline|Measure human growth hormone at times 0-120 minutes on two occasions about one week apart. On one occasion, the proprietary amino acid derivative blend will be given orally at time 0 in capsule form, and on the other occasion the capsules will contain no amino acids.|0-120 minutes, at Baseline and post dose, week 1 and week 3|||percentage of change||Standard Deviation|Mean
682527|NCT01540487|Secondary|AUC0-tz for Linagliptin||1 hour (h) prior to drug administration, 20 minutes (min), 40 min, 1 h, 1 h 30 min, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 34 h, 48 h and 72 h thereafter.|Treated Set||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
682528|NCT01540487|Secondary|AUC(0-infinity) for Metformin|AUC0-infinity is based on predicted last concentration values.|1 hour (h) prior to drug administration, 20 minutes (min), 40 min, 1 h, 1 h 30 min, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 34 h, 48 h and 72 h thereafter.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
682529|NCT01540487|Secondary|Area Under the Concentration Time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity) for Linagliptin|AUC0-infinity is based on predicted last concentration values.|1 hour (h) prior to drug administration, 20 minutes (min), 40 min, 1 h, 1 h 30 min, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 34 h, 48 h and 72 h thereafter.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
682530|NCT01540487|Primary|Maximum Measured Concentration (Cmax) of Metformin||1 hour (h) prior to drug administration, 20 minutes (min), 40 min, 1 h, 1 h 30 min, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 34 h, 48 h and 72 h thereafter.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
682531|NCT01540487|Primary|Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval 0 to the Last Quantifiable Concentration (AUC0-tz)||1 hour (h) prior to drug administration, 20 minutes (min), 40 min, 1 h, 1 h 30 min, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 34 h, 48 h and 72 h thereafter.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
682532|NCT01540487|Primary|Maximum Measured Concentration (Cmax) of Linagliptin.||1 hour (h) prior to drug administration, 20 minutes (min), 40 min, 1 h, 1 h 30 min, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 34 h, 48 h and 72 h thereafter.|Treated Set.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
682533|NCT01540487|Primary|Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval 0 to 72 Hours (AUC0-72)||1 hour (h) prior to drug administration, 20 minutes (min), 40 min, 1 h, 1 h 30 min, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 34 h, 48 h and 72 h thereafter.|Treated Set.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
682534|NCT01540370|Primary|Inter- Examiner Agreement in Angle Width by Goniometric Lens|Inter-rater agreement (among 6 raters) of Large Step angle width (range: 0.5 to 5.5 with 0.5 unit intervals) was evaluated using weighted kappa (Fleiss-Cohen) statistics. The angle is the area between the iris and cornea of the eye. Each examiner performed a pair of angle-width measurements by goniometric lens predilation (ie, 2 measurements per examiner). The degree of agreement within raters was interpreted according to Landis and Koch, where: <0:poor, 0.00-0.20:slight, 0.21-0.40:fair, 0.41-0.60:moderate, 0.61-0.80:substantial, and 0.81-1.00:almost perfect.|Day 1|Modified Intent to Treat: enrolled patients with unobstructed and measurable inferior angles by goniometric reading and anterior segment optical coherence tomography (OCT)||Kappa statistics|||Number
682535|NCT01540370|Primary|Intra- Examiner Agreement in Angle Width by Goniometric Lens|Intra-rater agreement (for each of the 6 raters) of Large Step angle width (range: 0.5 to 5.5 with 0.5 unit intervals) was evaluated using weighted kappa (Fleiss-Cohen) statistics. The angle is the area between the iris and cornea of the eye. Each examiner performed a pair of angle-width measurements by goniometric lens predilation (ie, 2 measurements per examiner). The degree of agreement within raters was interpreted according to Landis and Koch, where: <0:poor, 0.00-0.20:slight, 0.21-0.40:fair, 0.41-0.60:moderate, 0.61-0.80:substantial, and 0.81-1.00:almost perfect.|Day 1|Modified Intent to Treat: enrolled patients with unobstructed and measurable inferior angles by goniometric reading and anterior segment optical coherence tomography (OCT)||Kappa statistics|||Number
682536|NCT01540266|Secondary|Estimates of the Current Status||5 minutes||||||
682537|NCT01540266|Secondary|Estimates of the Quality of the Communication||5 minutes||||||
682538|NCT01540266|Primary|Number of Items Recalled From the Communication in the Video|The students in the structured condition and the students in the non-structured condition were independently shown a video in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form. The key memory measure of interest was immediate recall performance expressed as the number of items recalled from the overall 28 items in the two videos. Participants’ recall protocols were evaluated by two independent raters, one of whom rated all protocols and the other, only a subset of them. Analyses of the agreement between the two raters resulted in a Cohen’s kappa of 0.74, indicating substantial interrater reliability according to Landis and Koch (35). In case of disagreement between the two raters, consensus was reached through joint analysis and discussion of the protocols.|5 minutes|||number of items recalled||Standard Deviation|Mean
682539|NCT01540162|Secondary|The Number (Rate) of Patients With Acute Respiratory Infections|ARI: Acute Rhinitis, Acute Rhinopharyngitis, Acute Bronchitis, Acute Bronchiolitis and Pneumonia|first 12 month of life|||participants|||Number
682540|NCT01540162|Secondary|The Number (Rate) of Patients With Acute Respiratory Infections|ARI: Acute Rhinitis, Acute Rhinopharyngitis, Acute Bronchitis, Acute Bronchiolitis and Pneumonia|first 6 month of life|||participants|||Number
682541|NCT01540162|Primary|The Number (Rate) of Patients With Acute Respiratory Infections|ARI: Acute Rhinitis, Acute Rhinopharyngitis, Acute Bronchitis, Acute Bronchiolitis and Pneumonia|first 28 days of life|||participants|||Number
682542|NCT01540045|Primary|Dysgeusia (BITTER Dilutions Dichotomized)|We divide dilutions in two groups and dichotomized the patients into high and low sensibility to umami, bitter and sweet tastes|pre - post chemotherapy (6 weeks)|||participants|||Number
682543|NCT01540045|Primary|Dysgeusia (SWEET Dilutions Dichotomized)|We divide dilutions in two groups and dichotomized the patients into high and low sensibility to sweet taste.|pre - post chemotherapy (6 weeks)|we dichotomized the patients into high or low sensibility to umami, bitter and sweet tastes pre-postchemotherapy||participants|||Number
682544|NCT01540045|Primary|Dysgeusia (UMAMI Dilutions Dichotomized)|We divide dilutions in two groups and dichotomized the patients into high and low sensibility to umami taste. (perception)|pre - post chemotherapy (6 weeks)|||participants|||Number
682545|NCT01540045|Primary|Dysgeusia (BITTER Recognition)|"Describe the recognition threshold (RT) of bitter taste with 5 dilutions with different concentrations.
The patients were instructed to taste each 5 ml dilution in ascending order and to rinse the dilution around the entire oral cavity. After each rinse, the patients were asked whether the sample they took tasted different from water to identify their PT, which was assigned to the lowest concentration at which the subject perceived a difference in taste from water. If so, then the patients were asked to identify the taste to define their RT, which was assigned to the lowest concentration at which the subject identified the taste."|Change from Baseline in threshold of perception at 6 weeks|||μmol/ml||Full Range|Median
682595|NCT01539525|Secondary|Mean Cost for Each Intervention|The data table includes the mean cost for implementation of each intervention from the societal perspective. The costs do not include the research costs|6 months|This outcome was restricted to participants who had a time stamp for their intervention (n=11 were missing) and had all 6 months of follow-up data.||dollars|participants|Standard Deviation|Mean
682546|NCT01540045|Primary|Dysgeusia (BITTER Perception)|"Describe the perception threshold (PT) of bitter taste with 5 dilutions with different concentrations.
The patients were instructed to taste each 5 ml dilution in ascending order and to rinse the dilution around the entire oral cavity. After each rinse, the patients were asked whether the sample they took tasted different from water to identify their PT, which was assigned to the lowest concentration at which the subject perceived a difference in taste from water. If so, then the patients were asked to identify the taste to define their RT, which was assigned to the lowest concentration at which the subject identified the taste."|Change from Baseline in threshold of perception at 6 weeks|||μmol/ml||Full Range|Mean
682547|NCT01540045|Primary|Dysgeusia (SWEET Recognition)|"Describe the recognition threshold (RT) of sweet taste with 5 dilutions with different concentrations.
The patients were instructed to taste each 5 ml dilution in ascending order and to rinse the dilution around the entire oral cavity. After each rinse, the patients were asked whether the sample they took tasted different from water to identify their PT, which was assigned to the lowest concentration at which the subject perceived a difference in taste from water. If so, then the patients were asked to identify the taste to define their RT, which was assigned to the lowest concentration at which the subject identified the taste."|Change from Baseline in threshold of perception at 6 weeks|||μmol/ml||Full Range|Median
682548|NCT01540045|Primary|Dysgeusia (SWEET Perception)|"Describe the threshold perception (PT) of sweet taste with 5 dilutions with different concentrations.
The patients were instructed to taste each 5 ml dilution in ascending order and to rinse the dilution around the entire oral cavity. After each rinse, the patients were asked whether the sample they took tasted different from water to identify their PT, which was assigned to the lowest concentration at which the subject perceived a difference in taste from water. If so, then the patients were asked to identify the taste to define their RT, which was assigned to the lowest concentration at which the subject identified the taste."|Change from Baseline in threshold of perception at 6 weeks|For the paired analysis of taste acuity we used Wilcoxon for difference between baseline and 6 weeks later.||μmol/ml||Full Range|Median
682549|NCT01540045|Secondary|Global Status of Quality of Life (C-30,LC13 EORTC)|"differences in global status of QoL scale (C-30,LC13 EORTC) between those with more or less sensibility to recognize the umami taste.
score of scale 0-100, a higher score represents better overall state."|time between baseline and before 2 cycles of chemotherapy, an average of 6 weeks|||units on a scale||Inter-Quartile Range|Median
682550|NCT01540045|Secondary|Peripheral Neuropathy (QLQ-C30 Version 3, EORTC)|comparison of peripheral neuropathy patients who increased or decreased their sensibility to the PT of umami taste The HRQL evaluation was assessed using the validated Mexican-Spanish version of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaires specific for cancer and for LC (EORTC-QLQ-C30 and QLQ-LC13). Scores for the multi-item functional or symptom scales and the single items scales were calculated using a linear transformation of raw scores to produce a range from 0 to 100, as described by EORTC. A score of 100 represents the best score for the global health status and functional scales of QoL or 0 in the symptom rating.|participants were followed for the duration of 2 cycles of chemotherapy, an average of 6 weeks|||Units on a scale||Full Range|Median
682551|NCT01540045|Secondary|Change From Baseline in Albumin After 2 Cycles of Chemotherapy|comparison of patients who increased or decreased their sensibility to the PT of umami taste|participants were evaluated baseline and after 2 cycles of chemotherapy, an average of 6 weeks|||g/dL||Standard Deviation|Mean
682552|NCT01540045|Secondary|Quality o f Life|The HRQL evaluation was assessed using the validated Mexican-Spanish version of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaires specific for cancer and for LC (EORTC-QLQ-C30 and QLQ-LC13). [18, 19] Scores for the multi-item functional or symptom scales and the single items scales were calculated using a linear transformation of raw scores to produce a range from 0 to 100, as described by EORTC. A score of 100 represents the best score for the global health status and functional scales of QoL or 0 in the symptom rating.|participants were evaluated baseline and after 2 cycles of chemotherapy, an average of 6 weeks|||Scores on a scale||Full Range|Median
682553|NCT01540045|Primary|Dysgeusia (UMAMI Recognition)|"Describe the threshold recognition (RT) of umami with 5 dilutions with different concentrations.
The patients were instructed to taste each 5 ml dilution in ascending order and to rinse the dilution around the entire oral cavity. After each rinse, the patients were asked whether the sample they took tasted different from water to identify their PT, which was assigned to the lowest concentration at which the subject perceived a difference in taste from water. If so, then the patients were asked to identify the taste to define their RT, which was assigned to the lowest concentration at which the subject identified the taste."|Change from Baseline in threshold of perception at 6 weeks|For the paired analysis of taste acuity we used Wilcoxon for difference between baseline and 6 weeks later.||μmol/ml||Full Range|Median
682554|NCT01540045|Secondary|IRON Consumption|IRON consumption was estimated by questionnaire SNUT difference between ≥ Sweet perception thresholds vs < Sweet perception thresholds after chemotherapy|participants were evaluated baseline and after 2 cycles of chemotherapy, an average of 6 weeks|||mg||Standard Deviation|Mean
682555|NCT01540045|Secondary|PROTEIN AND FAT Consumption|energy and nutrimental consumption was estimated by questionnaire SNUT difference between ≥ Sweet perception thresholds vs < Sweet perception thresholds after chemotherapy|participants were evaluated baseline and after 2 cycles of chemotherapy, an average of 6 weeks|||gr||Standard Deviation|Mean
682556|NCT01540045|Secondary|Subjective Global Assessment|validated questionnaire to identify patients with malnutrition or risk of malnutrition Subjective global assessment (PG-SGA) was used to assess and classify patients as having severe or moderate malnourishment (B or C) or as being well nourished (A).|descriptive values before chemotherapy|||participants|||Number
682557|NCT01540045|Secondary|Body Mass Index|Body mass index, using the formula kg/m^2|Change from Baseline in threshold of perception and recognition at 6 weeks|||kg/m^2||Standard Deviation|Mean
682558|NCT01540045|Secondary|BODY COMPOSITION|fat mass and lean body mass pre-post chemotherapy|Change from Baseline in perception and recognition thresholds at 6 weeks|||kg||Standard Deviation|Mean
682596|NCT01539525|Secondary|Rates of STDs|rates of incident std's per patient's medical records|baseline to 6 months|||participants|||Number
682597|NCT01539525|Primary|Treatment Utilization|Treatment utilization assessed via participant self-report at each follow-up interview, and with the exception of self-help groups, verified with providers. We also reviewed the medical record for use of medication indicative of treatment (e.g., nicotine replacement therapy).|baseline to 6 months|||participants|||Number
682559|NCT01540045|Primary|Dysgeusia (UMAMI Perception)|"Describe the threshold of perception and recognition (PT and RT, respectively) umami) with 5 dilutions with different concentrations.
The patients were instructed to taste each 5 ml dilution in ascending order and to rinse the dilution around the entire oral cavity. After each rinse, the patients were asked whether the sample they took tasted different from water to identify their PT, which was assigned to the lowest concentration at which the subject perceived a difference in taste from water. If so, then the patients were asked to identify the taste to define their RT, which was assigned to the lowest concentration at which the subject identified the taste."|Change from Baseline in threshold of perception at 6 weeks|||μmol/ml||Full Range|Median
682560|NCT01539980|Secondary|Liver Enzyme (AST)|Large, open wound may absorb some materials from wound dressing. If those materials are toxic, liver enzyme (a major organ for elimination of any toxicities) will be increased.|Within 14 days after operation|||u/L||Standard Deviation|Mean
682561|NCT01539980|Secondary|Proinflammatory Cytokines (IL)|The proinflammatory cytokines from wound exudate will be measured for predicting the inflammatory level. ELISA kit is used.|Within 14 days after operation|||pg/mL||Standard Deviation|Mean
682562|NCT01539980|Secondary|Pain Levels of Wounds|Pain may occur on operation wounds. Visual analog scale is used by patients themselves for monitoring the pain level with 0 = no pain, 10 = worst possible pain.|Within 14 days after operation|||units on a scale||Standard Deviation|Mean
682563|NCT01539980|Secondary|Clinical Safety of Wound Dressing Containing Silk Sericin for Split-thickness Skin Graft Donor Site Treatment|Number of patients with infected wound|Within 14 days after operation|||Number of patients with infected wound|||Number
682564|NCT01539980|Primary|Clinical Efficacy of Wound Dressing Containing Silk Sericin for Split-thickness Skin Graft Donor Site Treatment|Time for complete epithalization is duration between finishing surgical procedure and the dressing spontaneously peeling off from donor sites without causing pain. The wounds completely close and without fluid leakage and are able to exposed to the environment without pain. This duration should not exceed than 14 days.|Within 14 days after operation|||Days||Standard Deviation|Mean
682565|NCT01539811|Secondary|Length of Antibiotics|Length of antibiotic|6 weeks||||||
682566|NCT01539811|Secondary|Hospital Stay|Length of hospital stay, total cost of hospital stay|2 weeks||||||
682567|NCT01539811|Secondary|Clearance of Infection|Clearance of infection (as determined by negative culture, normal complete blood count (CBC), erythrocyte sedimentation rate (ESR), and C-Reactive protein (CRP)|6 weeks||||||
682568|NCT01539811|Secondary|Reinfection/Reintervention|Reinfection or Reintervention to the operative site|3 months||||||
682569|NCT01539811|Primary|Wound Healing|Wound healing at 3 months (75% epithelialization) from the time of the final definitive operation.|3 months||||||
682573|NCT01539642|Primary|Time-weighted Summed Pain Intensity Difference (SPID) Over the 48-hour Study Period (SPID-48).|"SPID-48 is the sum of the pain intensity difference (PID) over the 48 hour time period. A pain intensity score of 0 (no pain) to 10 (worse possible pain) is obtained before starting the study and throughout the 48 time period. The pain score at each assessment time is subtracted from the baseline pain score to provide the total sum score or SPID-48. A higher SPID-48 is better and indicates a reduction in pain intensity compared to the baseline score. The range of SPID48 scores were -232 to 326.
Time-weighted SPID48 = ∑ [T(i) – T(i-1)] x PID(i), where T(0) = Time 0 (baseline), T(i) is the scheduled or unscheduled assessment time, and PID(i) is the PID score at time i for i=0 to 48 hours.
Note: Active group n=114 and placebo group n=58, instead of active n=115 and placebo n=57, due to one active patient receiving placebo inadvertently."|48 hours|||Units on a scale||Standard Error|Least Squares Mean
682574|NCT01539590|Secondary|Symptoms and Clinical Signs of CHF|Symptoms and clinical signs of CHF measured by NYHA classification|6 months||||||
682575|NCT01539590|Secondary|Change in Body Weight||6 months||||||
682576|NCT01539590|Secondary|Change From Baseline eCrCl||6 months||||||
682577|NCT01539590|Secondary|Development of Ventricular Fibrillation or Other Life-threatening Arrhythmia||6 months||||||
682578|NCT01539590|Secondary|All-cause Mortality||6 months||||||
682579|NCT01539590|Secondary|Frequency of MACCE||6 months||||||
682580|NCT01539590|Secondary|Frequency of AE, SAEs||6 months||||||
682581|NCT01539590|Secondary|Incidence of Complete ST Segment Resolution 60 ± 30 Minutes After Last Angiogram||6 months||||||
682582|NCT01539590|Secondary|Number of Hospitalizations for CHF Through 6 Months||6 months||||||
682583|NCT01539590|Secondary|Frequency of New Onset CHF Through 6 Months||6 months||||||
682584|NCT01539590|Secondary|Frequency of MACE||6 months||||||
682585|NCT01539590|Secondary|Change in Regional Myocardial Radial, Circumferential and Longitudinal Strain||1 and 6 months||||||
682586|NCT01539590|Secondary|Change Between Initial Semi-quantitative Regional Wall Motion Score (17 Segment Model) by Echocardiography||1 and 6 months||||||
682587|NCT01539590|Secondary|LVEDVI, LVESVI and LVEF After MI Assessed by 2D and 3D Echocardiography||6 months||||||
682588|NCT01539590|Secondary|Change in LVEDVI, LVESVI and LV Ejection Fraction (EF) After MI Assessed by Cine MR (SSFP Imaging)||6 months||||||
682589|NCT01539590|Secondary|Change in Symptoms and Clinical Signs of CHF||6 months||||||
682590|NCT01539590|Secondary|Change in BNP Levels||6 months||||||
682591|NCT01539590|Secondary|Change in CK-MB and Troponin||6 months||||||
682592|NCT01539590|Primary|Evaluation of the Degree of Late Ventricular Remodeling|Evaluation of the degree of late ventricular remodeling between the BB3 and placebo treatment groups at 6 months, as measured by increase in LV end-diastolic volume index (LVEDVI) from initial MR image (day 5±1) to late MR image (6 months).|6 months||||||
682593|NCT01539590|Primary|Evaluation of Reduction in Infarct Size|Evaluation of reduction in infarct size by MRI between the BB3 and placebo treatment groups at 6 months based on index of myocardial salvage|6 month|Five subjects were enrolled into the study; 3 subjects were randomized to BB3 and 2 subjects to placebo. Of the 3 subjects randomized to BB3, 1 completed study treatment; all three subjects discontinued the study prematurely. The two subjects randomized to placebo completed study treatment and neither discontinued the study prematurely.|||||
682601|NCT01539512|Secondary|Lymph Node Response Rate|Lymph node response rate was defined as the percentage of participants who achieved a ≥ 50% decrease from baseline in the SPD of index lymph nodes.|Up to 17 months|ITT Analysis Set: randomized participants with treatment group designated according to initial randomization||percentage of participants||95% Confidence Interval|Number
682602|NCT01539512|Secondary|Overall Response Rate|"Overall response rate was defined as the percentage of participants who achieved a best overall response of complete response or partial response.
Complete response was defined as no lymphadenopathy, hepatomegaly, splenomegaly; normal complete blood count; confirmed by bone marrow aspirate & biopsy.
Partial response was defined as >1 of the following criteria: a 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver size, spleen size; plus ≥ 1 of the following: ≥ 1500/μL absolute neutrophil count, > 100000/μL platelets, > 11.0 g/dL hemoglobin or 50% improvement for either of these parameters without transfusions or growth factors."|Up to 17 months|ITT Analysis Set: randomized participants with treatment group designated according to initial randomization.||percentage of participants||95% Confidence Interval|Number
682603|NCT01539512|Primary|Progression-Free Survival|Progression-free survival was defined as the interval from randomization to the earlier of the first documentation of definitive disease progression or death from any cause. Definitive disease progression was CLL progression based on standard criteria (other than lymphocytosis alone) as defined by the 2008 update of the International Workshop on CLL guidelines, ie, appearance of any new lesion; increase by ≥ 50% in the sum of the products of the perpendicular diameters of measured lymph nodes (SPD); new or ≥ 50% enlargement of liver or spleen; transformation to a more aggressive histology (eg, Richter's or prolymphocytic transformation); reduction in the number of blood cells (cytopenia) attributable to CLL.|Up to 17 months|Intent-to-Treat (ITT) Analysis Set: randomized participants with treatment group designated according to initial randomization.||months||95% Confidence Interval|Median
682604|NCT01539317|Secondary|Improvement of Quality of Sexual Life - Visit 3|To determine whether women's quality of sexual life is improved by use of this local therapy to prevent pain with intercourse. Measured by average scores on the Sexual Function Questionnaire. There are 8 domains measured in the Sexual Function Questionnaire each asking for a score for the prior 30 days: Desire (score range 5-31; ≥23 considered normal function), Arousal-sensation (score range 4-20; ≥14 considered normal function), Arousal-lubrication (score ranges 2-10; ≥8 considered normal function), Arousal-cognitive (score range 2-10; ≥8 considered normal function), Orgasm (score range 1-15; ≥12 considered normal function), Pain (2-15; ≥12 considered normal function), Enjoyment (score range 6-30; ≥23 considered normal function) and Partner (score range 2-10; ≥8 considered normal function).|Visit 3 (End of Study)|Averaged scores of Sexual Function Questionnaire at Visit 1 scoring from the prior 30 days.||Units on a scale||Inter-Quartile Range|Mean
682605|NCT01539317|Secondary|Improvement of Quality of Sexual Life - Visit 2|To determine whether women's quality of sexual life is improved by use of this local therapy to prevent pain with intercourse. Measured by averaged scores on the Sexual Function Questionnaire. There are 8 domains measured in the Sexual Function Questionnaire each asking for a score for the prior 30 days: Desire (score range 5-31; ≥23 considered normal function), Arousal-sensation (score range 4-20; ≥14 considered normal function), Arousal-lubrication (score ranges 2-10; ≥8 considered normal function), Arousal-cognitive (score range 2-10; ≥8 considered normal function), Orgasm (score range 1-15; ≥12 considered normal function), Pain (2-15; ≥12 considered normal function), Enjoyment (score range 6-30; ≥23 considered normal function) and Partner (score range 2-10; ≥8 considered normal function).|Visit 2 (Week 4)|Averaged scores of Sexual Function Questionnaire at Visit 2 scoring from the prior 30 days.||Units on a scale||Inter-Quartile Range|Mean
682606|NCT01539317|Primary|Location of Pain in Postmenopausal Dyspareunia|"To determine the specific site of vulvovaginal tenderness in menopausal breast cancer survivors who have entry dyspareunia. Examine the vulvar vestibule with a swab test to determine locations and severity of touch tenderness. Eight sites were evaluated around the vaginal opening and there location was in reference to a clock face. Measured using the Numerical Rating Scale, a scale which measures pain from 0 to 10 with 0=no pain and 10=the worst pain you have ever felt."|Enrollment visit|||units on a scale from 0 to 10||Inter-Quartile Range|Median
682607|NCT01539317|Secondary|Improvement of Quality of Sexual Life - Visit 1|To determine whether women's quality of sexual life is improved by use of this local therapy to prevent pain with intercourse. Measured by average scores on the Sexual Function Questionnaire. There are 8 domains measured in the Sexual Function Questionnaire each asking for a score for the prior 30 days: Desire (score range 5-31; ≥23 considered normal function), Arousal-sensation (score range 4-20; ≥14 considered normal function), Arousal-lubrication (score ranges 2-10; ≥8 considered normal function), Arousal-cognitive (score range 2-10; ≥8 considered normal function), Orgasm (score range 1-15; ≥12 considered normal function), Pain (2-15; ≥12 considered normal function), Enjoyment (score range 6-30; ≥23 considered normal function) and Partner (score range 2-10; ≥8 considered normal function).|Visit 1 (Enrollment)|Averaged scores of Sexual Function Questionnaire Visit 1 each time scoring from the prior 30 days.||units on a scale||Inter-Quartile Range|Mean
682608|NCT01539317|Primary|Prevention of Entry Dyspareunia With Non-hormonal Therapy|"Mean intercourse pain reported by subjects using the Numerical Rating Scale pain ratings (range 0-10, 0 being no pain and 10 being worst possible pain). Testing was during weeks 0-4 (Phase II) (with blinded randomization for placebo vs active intervention medication) and testing was during weeks 5-12 (Phase III) (with open-label active medication for 8 weeks after completing the blinded 4 weeks). Subjects agreed to try penetration twice per week and score their pain using the Numerical Rating Scale pain ratings.The scores were averaged during each phase."|During Phase II (0-4 weeks) and during Phase III (5-12 weeks)|||Units on a scale||Inter-Quartile Range|Mean
682609|NCT01539135|Secondary|Number of Participants With Unanticipated Intensive Care Unit Admission|Incidence of unscheduled Intensive Care Unit admission after surgery and length of ICU stay if applicable.|Time from discharge from PACU to discharge from hospital up to 72 hours|||participants|||Number
682610|NCT01539135|Secondary|Number of Participants With Postoperative Pneumonia|Diagnosis of postoperative pneumonia during the 30 day follow up period after surgery|Up to 30 days after surgery|||participants|||Number
682611|NCT01539135|Secondary|Length of Hospital Stay|Time of readiness for discharge from PACU, defined as when an Aldrete score of greater than or equal to 8 is given, to the time at which discharge (from the hospital) orders are written. The inpatient period may extend up to 72 hours.|Time from discharge from PACU to discharge from hospital up to 72 hours|||hours||Standard Deviation|Mean
682612|NCT01539135|Primary|Number of Participants With Dye Leakage|Blue dye will be instilled above the endotracheal tube cuff immediately after intubation where it will remain for the duration of the surgery. The presence of dye leakage past the endotracheal tube cuff will be determined via analysis of bronchoscopic images taken at the end of the surgical procedure when surgical closure has begun.|Duration of surgical procedure - from 2 to 12 hours|||participants|||Number
682613|NCT01539083|Secondary|Consolidation Phase: Change From Baseline in FACT/GOG-NTX Total Score at the End of the Consolidation Phase|Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTX) consists of 10 items and evaluates symptoms and concerns associated specifically with chemotherapy-induced neuropathy. 1 FACT/GOG-NTX total score has a range of 0 to 108 with a higher score indicating better quality of life.|Baseline, Month 12|All treated randomized analysis set was defined as participants in the all enrolled set (participants with non-missing informed consent date,not screen failures) received at least 1 dose of any study drug and randomized to receive consolidation treatment. Here, 'N'(number of participants analyzed) participants who were evaluable for this endpoint.||units on a scale||Standard Deviation|Mean
682614|NCT01539083|Secondary|Consolidation Phase: Change From Baseline in AQOL-6D Scores at the End of the Consolidation Phase|The assessment of quality of life-6D (AQoL-6D) is a multi-attribute health-related quality of life instrument (QoL). It comprises dimension scores for independent living, relationships, mental health, coping, pain, senses, and utility score for AQol-6D. Each scale ranges between 1 (best QoL) and -0.04 (worst possible QoL).|Baseline, Month 12|All treated randomized analysis set was defined as participants in the all enrolled set (participants with non-missing informed consent date,not screen failures) received at least 1 dose of any study drug and randomized to receive consolidation treatment. Here, 'N'(number of participants analyzed) participants who were evaluable for this endpoint.||units on a scale||Standard Deviation|Mean
682615|NCT01539083|Secondary|Consolidation Phase: Overall Survival (OS)|OS was defined as the time between randomization and death. Death of a participant regardless of the cause was considered as an event.|Up to 3 years|All randomized analysis set was defined as participants in the all enrolled set (all participants with a non-missing informed consent date and were not screen failures) who were randomized to receive consolidation treatment.||months||95% Confidence Interval|Median
682616|NCT01539083|Secondary|Consolidation Phase: Disease-free Survival (DFS)|DFS, defined as the duration from the start of CR to the time of relapse from CR. DFS applied only to participants in CR. CR as per IMWG criteria is negative immunofixation on serum and urine and disappearance of soft tissue plasmacytomas and <5 percent plasma cells in bone marrow. Relapse from CR: reappearance of serum or urine M-protein by immunofixation or electrophoresis; development of >= 5 percent plasma cells in the bone marrow; appearance of any other sign of progression (ie, new plasmacytoma, lytic bone lesion, or hypercalcaemia).|Up to 3 years|Response-evaluable-randomized analysis set defined as all participants in the response-evaluable-induction set (who received at least 1 dose of study medication;had measurable disease at baseline) who were randomized to receive consolidation treatment. Here, ‘N’ (number of participants analyzed) signifies the participants who had complete response.||months||95% Confidence Interval|Median
682617|NCT01539083|Secondary|Consolidation Phase: Progression Free Survival (PFS)|PFS, calculated as the time between randomization to disease progression or death (regardless of cause), whichever occurred first. Progressive disease as per IMWG criteria: increase of >= 25 percent from lowest response level in Serum M-component and/or (the absolute increase must be >=0.5 gram per deciliter [g/dL]) Urine M-component and/or (the absolute increase must be >=200 mg/24 hour. Only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain levels. The absolute increase must be >10 mg/dL. Bone marrow plasma cell percentage: the absolute percent must be >=10 percent. Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas. Development of hypercalcemia (corrected serum calcium >11.5 mg/dL or 2.65 millimole per liter (mmol/L) that can be attributed solely to the plasma cell proliferative disorder.|Baseline until progressive disease (up to 3 years)|All response-evaluable-randomized analysis set was defined as all participants in the response-evaluable-induction set (all participants who received at least 1 dose of study medication in the induction phase and had measurable disease at baseline) who were randomized to receive consolidation treatment.||months||95% Confidence Interval|Median
682618|NCT01539083|Secondary|Consolidation Phase: Percentage of Participants With Stringent Complete Response (sCR) at Months 3, 6, 9 and 12|sCR as per IMWG criteria is CR plus normal free light chain (FLC) ratio and absence of clonal cells in bone marrow. CR is negative immunofixation on serum and urine and disappearance of soft tissue plasmacytomas and <5 percent plasma cells in bone marrow.|Months 3, 6, 9 and 12|All response-evaluable-randomized analysis set was defined as all participants in the response-evaluable-induction set (all participants who received at least 1 dose of study medication in the induction phase and had measurable disease at baseline) who were randomized to receive consolidation treatment.||percentage of participants|||Number
682619|NCT01539083|Secondary|Consolidation Phase: Percentage of Participants With Complete Response (CR) at Months 3, 6, 9 and 12|CR as per IMWG criteria is negative immunofixation on serum and urine and disappearance of soft tissue plasmacytomas and <5 percent plasma cells in bone marrow.|Months 3, 6, 9 and 12|All response-evaluable-randomized analysis set was defined as all participants in the response-evaluable-induction set (all participants who received at least 1 dose of study medication in the induction phase and had measurable disease at baseline) who were randomized to receive consolidation treatment.||percentage of participants|||Number
682620|NCT01539083|Primary|Consolidation Phase: Percentage of Participants With Complete Response (CR) and Very Good Partial Response (VGPR) at Month 12|CR as per IMWG criteria is defined as negative immunofixation on the serum and urine and disappearance of soft tissue plasmacytomas and less than (<) 5 percent plasma cells in bone marrow. VGPR as per IMWG criteria is defined as serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90 percent or greater reduction in serum M-protein plus urine M-protein level <100 milligram (mg) per 24 hours.|Month 12|All response-evaluable-randomized analysis set was defined as all participants in the response-evaluable-induction set (all participants who received at least 1 dose of study medication in the induction phase and had measurable disease at baseline) who were randomized to receive consolidation treatment.||percentage of participants|||Number
682621|NCT01539070|Primary|Change in Score z of Body Mass Index From Baseline to 3 Months by Intervention Assignment|In order to calculate children’s BMI and age and sex specific BMI z-scores at baseline and 3 month follow-up, study staff assessed child’s height in meters and weight in kilograms. BMI was calculated as weight in kilograms divided by the square of height in meters.|0, 3 month|||z score||Standard Error|Mean
682622|NCT01539070|Secondary|Number of Families That Completed 3 Month Follow-up in Intervention Group and Usual Care Group|We assessed the compliance with the study through attendiance appointments for assessing diet and physical activity.|3 months|||participants|||Number
682623|NCT01539070|Primary|Change in Children´s Time of Physical Activity From Baseline to 3 Months by Intervention Assignment|Staff assisted parents in reporting the average time the participating child spent in pre-specified active and sedentary activities during the week and on weekends. For each of the pre-specified activities parents reported time spent in open-ended response format. From these responses we derived total hours/week of physical activity composed of active play (e.g. running, jumping, walking, playing ball, playing in the park, biking, swimming, dancing), as well as total hours/week of screen time, composed of television, DVD/video, and video and computer games.|0, 3 months|In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 and to 6 months between the intervention and usual care groups.||hours/week||Standard Deviation|Mean
682624|NCT01539070|Primary|Change in Children´s Consumption of Foods From Baseline to 3 Months by Intervention Assignment|We asked parents about the average number of servings in the week or month the child consumed each food. We constructed grouped diet variables corresponding to food categories : sweet snacks (sugar-sweetened dairy, sugary cereal, cookies, sweet bread, cake, packaged pastries ], caramel pops, candies and chocolates); fast food (hamburgers, pizza, hot dogs, quesadillas, fried tacos, French fries); savory snacks (packaged snack foods, corn or potato chips); fruit (orange, mango, papaya, watermelon, grapes, apple, banana); vegetables (chard, broccoli, jitomate [tomato], nopales [cactus], chayote [squash], spinach, lettuce, zucchini, carrot); sugar-sweetened beverages (soda, flavored milk, homemade [agua fresca] and packaged fruit drinks); and added sugar in beverages (teaspoons sugar or sweet flavoring added to milk, coffee, tea, or fruit juice).|0, 3 months|Intent-to-treat analyses with multiple imputation to account for missing data. Were included in the analysis of children between 0 and 3 BMI z score, age between 24 and 59 months and parents signed letter of consent to participate in the study||servings/week||Standard Error|Mean
682625|NCT01538862|Secondary|Overall Improved Symptomatology|Overall clinical improvement in symptomatology and/or findings, as assessed by either the patient or parent. This would include decrease in the number and size of blister and erosions, decreased pain, improved comfort of the patient.|28 days|||Participants|||Count of Participants
682626|NCT01538862|Secondary|Surface Area of Nonhealing Erosions|Change in surface area of one or two nonhealing erosions|7 days|Time frame was originally entered as 30 days. This was not consistent with the protocol which listed a 7 day time frame for this Outcome||percentage change||Standard Deviation|Mean
682627|NCT01538862|Primary|Percent Change of Active Blisters and in Total Blister/Erosion Counts|Percent change of active blisters and in total blister/erosion counts from baseline to 7 days|7 days|Time frame was originally entered as 30 days. This was not consistent with the protocol which listed a 7 day time frame for this Outcome||percent change||Standard Deviation|Mean
682628|NCT01538472|Primary|3-Year Overall Survival|Number of participants alive 3 years following treatment. Evaluations done every 3 months for 1 year and then every 6 months to check on the status of the disease.|3 years|||percentage of participants|||Number
682629|NCT01538472|Primary|Overall Survival Median|Overall survival reported as number of days participants alive following treatment up to 5 years with annual follow up till disease progression. Evaluations done every 3 months for 1 year and then every 6 months for 5 years to check on the status of the disease, with long-term follow up as needed.|Participant followed from baseline treatment to 5 years, with study total period 8 years (study duration)|||days||Full Range|Median
682630|NCT01537900|Secondary|Plasma t½ of GZR|t1/2 is a measure of time for the maximum plasma concentration of GZR to decrease by 50%.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose on Day 7|Plasma PK data were not collected due to liver PK results being deemed physiologically impossible.|||||
682631|NCT01537900|Secondary|Time to Maximum Plasma Concentration (Tmax) of GZR|Tmax is a measure of time to reach maximum post-dose plasma drug concentration.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose on Day 7|Plasma PK data were not collected due to liver PK results being deemed physiologically impossible.|||||
682632|NCT01537900|Secondary|Lowest Plasma Concentration (Ctrough) of GZR|Ctrough is a measure of drug concentration 24 hours post-dose.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose on Day 7|Plasma PK data were not collected due to liver PK results being deemed physiologically impossible.|||||
682633|NCT01537900|Secondary|Maximum Plasma Concentration (Cmax) of GZR|Cmax is a measure of the maximum plasma concentration post-dose.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose on Day 7|Plasma PK data were not collected due to liver PK results being deemed physiologically impossible.|||||
682634|NCT01537900|Secondary|Plasma AUC[0-24 hr] of GZR|AUC0-24hr is a measure of the mean concentration of drug in plasma after dosing to 24 hours post-dose.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose on Day 7|Plasma PK data were not collected due to liver PK results being deemed physiologically impossible.|||||
682635|NCT01537900|Primary|Apparent Terminal Hepatic Half-life (t[H]½ ) of GZR|t(H)1/2 is a measure of the time required for the maximum post-dose liver concentration of GZR to decrease by 50%.|4, 8, 24, and 72 hours post-dose on Day 7|Apparent t(h)1/2 could not be estimated due to insufficient data in the terminal phase.|||||
682636|NCT01537900|Primary|Hepatic Concentration of GZR (C[H]Xhr)|C(H)Xhr of GZR was expressed as liver concentration (μmol GZR/L liver) using the concentration of the extracted liver sample (mass of the liver biopsy/0.2 mL solvent), and assuming that liver has the specific gravity of water (1 g/mL). The arithmetic mean C(H)Xhr concentration is based on the means of 4 FNA passes per participant in all 4 participants.|4, 8, 24, and 72 hours post-dose on Day 7|The PPP includes all participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of treatment.||µM||Standard Deviation|Mean
682637|NCT01537900|Primary|Estimated Area Under the Liver Concentration-time Curve for 24 Hours Post-dose (AUC[H]0-24hr) of Grazoprevir|Each participant was assigned to undergo Fine Needle Aspiration (FNA) to obtain liver tissue at different time points. Specifically, one participant underwent FNA at 4 hr post-dose only, another participant underwent FNA at 8 hr post-dose only, and a third participant underwent FNA at 24 hr post-dose only. (The fourth participant underwent FNA at 72 hr post-dose and therefore was not included in the calculation of AUC0-24hr.) Therefore, in calculating AUC0-24hr, there were only 3 data points: 1 data point at 4 hr post-dose, 1 data point at 8 hr post-dose, and 1 data point at 24 hr post-dose. The model assumed that drug concentration was at steady-state, and that the concentration at 24 hr post-dose was equal to the concentration at 0 hr post-dose.|4, 8, and 24 hours post-dose on Day 7|The per protocol population (PPP) includes all participants (4, 8, and 24 hr time points) who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of treatment. As each data point was obtained from unique participants, there is no measure of variability.||µM*hr|||Number
682638|NCT01537835|Secondary|Assess for Methicillin Resistent Staphylococcus Aureus, Vancomycin Resistant Enterococci, and Gram-negative Bacterial Contamination on Healthcare Worker Uniform With Antimicrobial Properties Compared to Standard Healthcare Worker Uniform.|Number of healthcare workers with methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant enterococci (VRE), and resistant gram-negative bacteria on the three scrub types, all obtained after the eight-hour workday.|8 hours|Healthcare workers randomized to one of three types of uniform||participants|||Number
682639|NCT01537835|Primary|Total Bacterial Contamination of Healthcare Worker Uniform With Antimicrobial Properties Compared to Standard Healthcare Worker Uniform After an 8-hour Workday.|Total bacterial colony count of samples obtained from the breast or lower front pocket, the sleeve cuff of the dominant hand and the pant leg at the mid-thigh of the dominant leg on all scrubs after an eight-hour workday.|8 hours|healthcare workers randomized to one of three types of uniform.||colony formation units||Inter-Quartile Range|Median
682640|NCT01537783|Primary|Recurrence of Cutaneous Abscess|A patient's description that they have had another abscess since their index emergency department visit.|6 months|||Participants|||Count of Participants
682641|NCT01537666|Secondary|Lung Pharmacokinetics - Minimum Sputum Concentration (Cmin)|"Sputum samples were obtained from the patients with cystic fibrosis to evaluate lung pharmacokinetics of vancomycin after a single dose administration of AeroVanc.
Cmin is the minimum observed concentration of a drug."|1, 8 and 24 hours post-dose|All CF patients who received a 32 mg dose of AeroVanc followed at least one week later by an 80 mg dose of AeroVanc (N=5). One patient withdrew after receiving a 32 mg dose and was replaced with a patient who only received an 80 mg dose.||µg/ml||Standard Deviation|Mean
682642|NCT01537666|Secondary|Lung Pharmacokinetics - Maximum Sputum Concentration (Cmax)|"Sputum samples were obtained from the patients with cystic fibrosis to evaluate lung pharmacokinetics of vancomycin after a single dose administration of AeroVanc.
Cmax is the maximum observed concentration of a drug."|1, 8 and 24 hours post-dose|All CF patients who received a 32 mg dose of AeroVanc followed at least one week later by an 80 mg dose of AeroVanc (N=5). One patient withdrew after receiving a 32 mg dose and was replaced with a patient who only received an 80 mg dose.||µg/ml||Standard Deviation|Mean
682643|NCT01537666|Secondary|Plasma Pharmacokinetics - Area Under the Plasma Concentration-time Curve From Time 0 to Infinite Time (AUCinf)|"Blood samples were obtained from the healthy volunteers to evaluate systemic pharmacokinetics of vancomycin after a single dose administration of AeroVanc or a single dose of IV vancomycin.
AUCinf is a way of estimating the total amount of drug exposure over an infinite time period."|Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose|All healthy volunteers (N=18) who received a single 16, 32, or 80 mg inhaled dose of AeroVanc. Subset (N=6 comprised of 2 patients from each of the AeroVanc groups) who received a single 250 mg IV dose of vancomycin.||h*ng/ml||Standard Deviation|Mean
682644|NCT01537666|Secondary|Plasma Pharmacokinetics - Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUCt)|"Blood samples were obtained from the healthy volunteers to evaluate systemic pharmacokinetics of vancomycin after a single dose administration of AeroVanc or a single dose of IV vancomycin.
AUCt is a way of expressing the total amount of drug exposure over a specified time period."|Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose|All healthy volunteers (N=18) who received a single 16, 32, or 80 mg inhaled dose of AeroVanc. Subset (N=6 comprised of 2 patients from each of the AeroVanc groups) who received a single 250 mg IV dose of vancomycin.||h*ng/ml||Standard Deviation|Mean
682645|NCT01537666|Secondary|Plasma Pharmacokinetics - Maximum Plasma Concentration (Cmax)|"Blood samples were obtained from the healthy volunteers to evaluate systemic pharmacokinetics of vancomycin after a single dose administration of AeroVanc or a single dose of IV vancomycin.
Cmax is the maximum observed concentration of a drug."|Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose|All healthy volunteers (N=18) who received a single 16, 32, or 80 mg inhaled dose of AeroVanc. Subset (N=6 comprised of 2 patients from each of the AeroVanc groups) who received a single 250 mg IV dose of vancomycin.||ng/ml||Standard Deviation|Mean
682646|NCT01537666|Secondary|Plasma Pharmacokinetics - Time to Reach the Maximum Plasma Concentration (Tmax)|"Blood samples were obtained from the healthy volunteers to evaluate systemic pharmacokinetics of vancomycin after a single dose administration of AeroVanc or a single dose of IV vancomycin.
Tmax is the time it takes to reach the maximum plasma concentration of a drug."|Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose|All healthy volunteers (N=18) who received a single 16, 32, or 80 mg inhaled dose of AeroVanc. Subset (N=6 comprised of 2 patients from each of the AeroVanc groups) who received a single 250 mg IV dose of vancomycin.||Hours||Standard Deviation|Mean
682647|NCT01537666|Secondary|Plasma Pharmacokinetics - Elimination Half Life (t½)|"Blood samples were obtained from the healthy volunteers to evaluate systemic pharmacokinetics of vancomycin after a single dose administration of AeroVanc or a single dose of IV vancomycin.
Half-life is the time it takes for the concentration of drug to decline by 50%."|Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose|All healthy volunteers (N=18) who received a single 16, 32, or 80 mg inhaled dose of AeroVanc. Subset (N=6 comprised of 2 patients from each of the AeroVanc groups) who received a single 250 mg IV dose of vancomycin.||Hours||Standard Deviation|Mean
682679|NCT01537068|Primary|Hamilton Rating Scale for Depression (HDRS24)|HDRS-24 total score, standardly used rating scale for depression. Score 0-7 no depression; Score 8-16 mild depression; Score 17-23 moderate depression; Score 24 and up severe depression. Range= 0 to 75, higher score=worse depression|Week 12|||units on a scale||Standard Deviation|Mean
682648|NCT01537666|Primary|Safety and Tolerability - Number of Participants With Treatment Emergent Adverse Events (TEAEs = Adverse Events That Started During or After the First Dose of Study Drug)|Each participant was monitored regularly for Adverse Events (AEs) throughout the study. The Investigator or designee enquired about AEs by asking participants non-leading questions such as: “How do you feel?” or “Have you had any (other) medical problems since your last visit/assessment?” Additionally, several safety procedures (physical examinations, vital signs, safety laboratory tests, 12-lead ECGs, and spirometry) were conducted on participants at regular intervals. All AEs reported spontaneously by participants or in response to questioning or observation by the Investigator, including those related to safety procedures, were recorded. For each AE, the Investigator recorded the following assessments: seriousness, severity (Mild, Moderate, or Severe), and relationship to study drug (Not Related, Remote, Possible, Probable, or Highly Probable). AEs were considered drug-related if given a relationship of Possible, Probable, or Highly Probable.|Healthy volunteers = 2 weeks; CF Patients = 1 week|All 18 healthy volunteers who received single doses of AeroVanc, 6 of which also received a single dose of IV vancomycin. All 7 Cystic Fibrosis patients who received at least one single dose of AeroVanc.||participants|||Number
682649|NCT01537549|Secondary|Cerebral Oxidative Stress Markers|changes of cerebral lactate and glutathione levels as determined by magnetic resonance spectroscopy|at baseline and at week 5|per Protocol||Ratio||Standard Deviation|Mean
682650|NCT01537549|Primary|Adverse Events|Incidence and severity of adverse events|at 25 weeks|ITT||Number of Adverse Events|||Number
682651|NCT01537432|Secondary|Percentage of Participants Achieving Skin Histological Disease Reversal at Week 52|"Histological sections of lesional and nonlesional skin biopsies at Week 52 were examined. For each visit, each patient’s lesional skin biopsy was scored for the degree of histological improvement compared to that patient’s baseline disease on a five point scale; -
1 (worse) to +3 (excellent). Histological disease reversal or “excellent improvement” (histological disease reversal score = 3) was declared at the endpoint when all of the following four criteria were met."|Week 52|PharmacoDynamic PD -All patients with at least one evaluable post-treatment PD measurement and no protocol deviations with relevant impact on PD data.||percentage of participants|||Number
682652|NCT01537432|Primary|Percentage of Participants Achieving Skin Histology Response After Secukinumab Treatment From Baseline to Week 12|"Histological sections of lesional and nonlesional skin biopsies at baseline and at Week 12 were examined. For each visit, each patient’s lesional skin biopsy was scored for the degree of histological improvement compared to that patient’s baseline disease on a five point scale; -
1 (worse) to +3 (excellent). Histological disease reversal or “excellent improvement” (histological disease reversal score = 3) was declared at the endpoint when all of the following four criteria were met."|Baseline, Week 12|PharmacoDynamic PD -All patients with at least one evaluable post-treatment PD measurement and no protocol deviations with relevant impact on PD data.||percentage of participants|||Number
682653|NCT01537367|Primary|The Percentage of Kept Divided by Scheduled Primary Care Visits, Excluding Cancelled (Second Measure).|Primary care visits are scheduled appointments for HIV-positive patients to see a physician, nurse practitioner, or physician assistant (a provider who can prescribe medication) at the HIV clinic.|12 months after enrollment|Intention to Treat (ITT)||Percentage of Pt kept visits/#scheduled|||Number
682654|NCT01537367|Secondary|Mean Counts Per Person (Rates) of Kept Visits.|The rate of kept clinic visits per person over 12 months.|12 months after enrollment|||# kept visits/person/12 months||Standard Error|Mean
682655|NCT01537367|Primary|The Percentage of Patients Attending a Primary Care Visit in Each of 3 Four-month Periods (First Measure)|Kept visits for each patient were assessed in 4-month periods over the 12 months of the intervention. This is a binary measure, requiring attendance at least once in each of the three 4-month periods.|12 months after enrollment|Intention to Treat (ITT)||percent in care each 4 month period|||Number
682656|NCT01537315|Primary|Change From Baseline in Inflammatory Marker, Hs-C Reactive Protein, at 6 Months|Hs-CRP will be measured at baseline (before study drug) and at end of study (6 months). This marker is measured by ELISA assay from serum.|Baseline and 6 months|||ng/ml||Standard Deviation|Mean
682657|NCT01537302|Secondary|Contrast/Flush Volumes|Evaluation of the contrast/flush volumes.|Day 0||||||
682658|NCT01537302|Secondary|Use of Assist Devices|Evaluation of the use of assist devices.|Day 0||||||
682659|NCT01537302|Secondary|Crossing Times|Evaluation of crossing times.|Day 0||||||
682660|NCT01537302|Secondary|Fluoroscopic Times|Evaluation of fluoroscopic times.|Day 0||||||
682661|NCT01537302|Secondary|Procedural Times|Evaluation of procedural times.|Day 0||||||
682662|NCT01537302|Secondary|Device Performance|Device performance as assessed by Investigator’s input by evaluating both performance of the device and quality of the OCT image as it relates to the ability to identify layered and non-layered structures and the ability of the directional marker bands to aid in orientation of the catheter while advancing through the CTO.|Day 0||||||
682663|NCT01537302|Secondary|Technical Success|Successful delivery, crossing and retrieval of the investigational device without the use of an assist device.|Day 0|201 Enrolled||participants|||Number
682664|NCT01537302|Secondary|Procedural Success|Successful delivery, crossing and retrieval of the investigational device in the absence of in-hospital MAEs, clinically significant perforations, clinically significant embolizations or Grade C or greater dissections.|Day 0|201 Enrolled||participants|||Number
682665|NCT01537302|Primary|Primary Efficacy Endpoint|Successful femoropopliteal CTO crossing using the Ocelot System as identified by guidewire placement in the distal true lumen confirmed by angiography.|Day 0|201 Enrolled||participants|||Number
682666|NCT01537302|Primary|Primary Safety Endpoint|No evidence of in-hospital MAEs, 30 day MAEs, clinically significant perforations, clinically significant embolizations or Grade C or greater dissections after Ocelot System CTO crossing confirmed by angiography.|Day 30|201 Enrolled, 2 Not Completed, 199 Analyzed||participants|||Number
682680|NCT01537068|Primary|Hamilton Rating Scale for Depression (HDRS24)|HDRS-24 total score, standardly used rating scale for depression. Score 0-7 no depression; Score 8-16 mild depression; Score 17-23 moderate depression; Score 24 and up severe depression. Range= 0 to 75, higher score=worse depression|Baseline|||units on a scale||Standard Deviation|Mean
684077|NCT01519960|Secondary|Percentage of Participants With Loss of HBeAg at EOT in Group C|The percentage of participants with loss of HBeAg at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|Safety Population.||percentage of participants||95% Confidence Interval|Number
682667|NCT01537198|Primary|Number of Subjects With Adverse Events (AEs), Serious AEs (SAEs), and Adverse Drug Reactions (ADRs)|An AE was defined as any untoward medical occurrence that did not necessarily have a causal relationship with treatment. An SAE was an event that resulted in death, was life-threatening, required or prolonged hospitalization, resulted in congenital anomaly or persistent or significant disability, important medical event requiring medical or surgical intervention to prevent serious outcome, or a spontaneous or elective abortion. AEs considered to be related to Synagis were classified as ADRs. The causality of ADRs were assessed by the investigator as 'Probable,' 'Possible' and 'others (unknown). 'Unexpected' AEs are those that are unlabeled.|From the time of informed consent until 30 days after the final administration of Synagis, an expected average of 6 months from the start of Synagis|||participants|||Number
682668|NCT01537185|Secondary|Immunogenicity Determined by the Number of Subjects With >4x Increase in Anti IgG|• Determination of a humoral immune response to whole cell antigen as determined by ELISA of sera collected on Day 0, 28, 56, and 84.|28, 56 and 84 days following initial vaccination|only subjects with both baseline and day 84 samples were included in the analysis.||participants|||Number
682669|NCT01537185|Primary|Unsolicited Adverse Event Reports|"Safety and Tolerability assessed by cohort and product received measured by:
•Number of unsolicited AEs within four weeks after each vaccination"|within 1 week (0-7 days) following each vaccinations|||participants|||Number
682670|NCT01537133|Primary|Microbial Community Evenness|Pielou’s evenness index is a scaled measure of biodiversity and is equal to the observed Shannon diversity index divided by the maximum possible Shannon diversity index, which would occur if all of the species in the sample were equally abundant. Evenness = D/log(S), where D is the Shannon Diversity index and log(S) is the maximum diversity of the sample.|baseline and after 6 weeks of treatment|Only baseline samples were collected from atopic non-asthmatics and healthy controls. Data was not available for all participants due to insufficient amplification in some samples.||Pielou’s evenness index||Inter-Quartile Range|Median
682671|NCT01537133|Primary|Microbial Community Diversity|The Shannon diversity index is a type of entropy measure and is a function of the distribution of the total number of organisms across all of the species. If S is the total number of species in the sample and p_i is the number of organisms in the i-th species divided by the total number of organisms, then Diversity = −Σ p_i log(p_i).|baseline and after 6 weeks of treatment|Only baseline samples were collected from atopic non-asthmatics and healthy controls. Data was not available for all participants due to insufficient amplification in some samples.||Shannon Diversity Index||Inter-Quartile Range|Median
682672|NCT01537133|Primary|Microbial Community Richness|Richness is the total number of different bacterial taxa detected in the sample.|baseline and after 6 weeks of treatment|Only baseline samples were collected from atopic non-asthmatics and healthy controls. Data was not available for all participants due to insufficient amplification in some samples.||number of bacterial taxa||Inter-Quartile Range|Median
682673|NCT01537120|Secondary|HbA1C At 12 Weeks|Blood samples were taken after 2 weeks of placebo treatment, and again after 12 weeks of vildagliptin treatment to measure the percentage of glycated hemoglobin, HbA1C. Units are therefore presented as HbA1c (%).|At 2 weeks after Placebo treatment and again at 12 weeks after Vildagliptin treatment|Per-Protocol Population: all participants who complied with the assigned medication during each period of study.||HbA1c (%)||Standard Deviation|Mean
682674|NCT01537120|Secondary|Hemoglobin A1C (HbA1C) At 2 Weeks|Blood samples were taken after 2 weeks of placebo treatment, and again after 2 weeks of vildagliptin treatment to measure the percentage of glycated hemoglobin, HbA1C. Units are therefore presented as HbA1c (%).|At 2 weeks after Placebo treatment and again at 2 weeks after Vildagliptin treatment|Per-Protocol Population: all participants who complied with the assigned medication during each period of study.||HbA1c (%)||Standard Deviation|Mean
682675|NCT01537120|Primary|24 Hour Weighted Mean Glucose (WMG) At 2 Weeks|The 24 hour WMG was measured after 2 weeks of placebo treatment, and again after 2 weeks of vildagliptin treatment. Glucose was measured over a 24 hour period by having participants wear two continuous glucose monitors (CGM), which produced an average glucose value approximately every 5 minutes. Using these values, the concentration of glucose was calculated from Area Under the Curve 0-24 hours (AUC 0-24hr), and was expressed as 24 hour WMG.|At 2 weeks after Placebo treatment and again at 2 weeks after Vildagliptin treatment|Per-Protocol Population: all participants who complied with the assigned medication during each period of study.||mg/dL||Geometric Coefficient of Variation|Geometric Mean
682676|NCT01537081|Primary|Summary Scores on the SUM8 Daily Cough and Phlegm Diary Card On the Morning of Day 5|Participants completed diary cards twice a day that asked questions about their cough and phlegm status. The Daily Cough and Phlegm Diary Card consisted of eleven questions, eight core questions plus three questions that were answered dependent upon the response to core questions. The SUM8 consisted of the sum of the answers to the eight core questions. Each question was answered on a scale of 0-4, with 4 representing the greatest severity of symptoms. The SUM8 thus had a scale range of 0-32 with 0 representing best possible symptoms, and 32 representing greatest severity of symptoms.|Day 5|Modified Intent-to-Treat(i.e., all randomized and treated subjects who had a baseline and at least 1 post-baseline set of assessments). Only participants who completed Daily Cough and Phlegm Diary Cards on the morning of Day 5 are included.||units on a scale||Standard Deviation|Mean
682677|NCT01537081|Primary|Summary Scores on the SUM8 Daily Cough and Phlegm Diary Card On the Morning of Day 4|Participants completed diary cards twice a day that asked questions about their cough and phlegm status. The Daily Cough and Phlegm Diary Card consisted of eleven questions, eight core questions plus three questions that were answered dependent upon the response to core questions. The SUM8 consisted of the sum of the answers to the eight core questions. Each question was answered on a scale of 0-4, with 4 representing the greatest severity of symptoms. The SUM8 thus had a scale range of 0-32 with 0 representing best possible symptoms, and 32 representing greatest severity of symptoms.|Day 4|Modified Intent-To-Treat (i.e., all randomized and treated subjects who had a baseline and at least 1 post-baseline set of assessments). Only participants who completed Daily Cough and Phlegm Diary Cards on the morning of Day 4 are included.||units on a scale||Standard Deviation|Mean
682678|NCT01537068|Secondary|Response Rate|Assessment of overall improvement: based on HDRS and Clinical Global Improvement Scale Response Rate is defined as 50% improvement of Hamd24 summary scores from baseline.|12 weeks|||Participants|||Count of Participants
682681|NCT01537042|Secondary|Change From Baseline in the Short-Form-36 (SF-36) Item Questionnaire Physical Component Summary (PCS) to the End of the Maintenance Period|"The SF-36 is a 36 item generic human research quality of life instrument that uses a recall period of 4 weeks. Items are grouped into 8 domains as follows: Physical Functioning (10 items), Role Physical (4 items), Bodily Pain (2 items), General Health (5 items), Vitality (4 items), Social Functioning (2 items), Role Emotional (3 items), Mental Health (5 items), and a further unscaled single item (question 2) for perceived stability or change in health (Health Transition) during the last year. The norm-based scores (based on the US general population) were used for analysis. For the PCS, the lowest and highest possible scores are 1 and 81 (rounded).
The SF-36 domains (subscores) are scored so that a higher score indicates a better health state."|From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period|Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period.||units on a scale||Standard Deviation|Mean
682682|NCT01537042|Secondary|Change From Baseline in the Short-Form-36 (SF-36) Item Questionnaire Mental Component Summary (MCS) to the End of the Maintenance Period|"The SF-36 is a 36 item generic human research quality of life instrument that uses a recall period of 4 weeks. Items are grouped into 8 domains as follows: Physical Functioning (10 items), Role Physical (4 items), Bodily Pain (2 items), General Health (5 items), Vitality (4 items), Social Functioning (2 items), Role Emotional (3 items), Mental Health (5 items), and a further unscaled single item (question 2) for perceived stability or change in health (Health Transition) during the last year. The norm based scores (based on the US general population) were used for analysis. For the MCS, the lowest and highest possible scores are -9 and 82 (rounded).
The SF-36 domains (subscores) are scored so that a higher score indicates a better health state."|From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period|Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period.||units on a scale||Standard Deviation|Mean
682683|NCT01537042|Secondary|Change From Baseline in the Restless Legs-Quality of Life (RLS-QoL) Total Score to the End of the Maintenance Period|"The RLS-QoL is a disease-specific questionnaire to evaluate quality of life. It consists of 12 items. A total score will be calculated from all of the 12 items. The overall sum score can be from 0 (highest QoL) to 60 (lowest QoL).
A negative value in Change from Baseline indicates an improvement from Baseline."|From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period|Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period.||scores on a scale||Standard Deviation|Mean
682684|NCT01537042|Secondary|Change From Baseline in Sleep Efficiency to the End of the Maintenance Period|"Sleep stages and time spent in each sleep stage are determined from Electroencephalogram (EEG) readings. Sleep stage data will be used to calculate sleep efficiency. Sleep efficiency will be presented as percentages. Sleep efficiency is the percentage of time in bed spent asleep.
A postive value in Change from Baseline indicates an improvement from Baseline."|From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period|Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period.||sleep time/ total time in bed||Standard Deviation|Mean
682685|NCT01537042|Secondary|Change From Baseline in the Periodic Limb Movement During Sleep Arousal Index (PLMSAI) to the End of the Maintenance Period|"The Periodic Limb Movement during Sleep Arousal Index (PLMSAI) reflects the influence of the PLM on subject's sleep. Arousal is defined as sudden change in the Electroencephalogram (EEG) activity and the index illustrates to what degree the PLMs contribute to arousal from sleep.
A negative value in Change from Baseline indicates an improvement from Baseline."|From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period|Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period.||movement per hour||Standard Deviation|Mean
682686|NCT01537042|Secondary|Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 6 to the End of the Maintenance Period|"The RLS-6 consists of six scales of which four scales are designed to assess severity of RLS and two scales cover sleep and daytime tiredness.
Scale 6 measures the severity of daytime tiredness/ sleepiness on an 11-point scale that ranges between 0 (not at all) to 10 (very severe). The ratings are given by the subjects.
A negative value in Change from Baseline indicates an improvement from Baseline."|From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period|Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period.||units on a scale||Standard Deviation|Mean
682687|NCT01537042|Secondary|Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 5 to the End of the Maintenance Period|"The RLS-6 consists of six scales of which four scales are designed to assess severity of RLS and two scales cover sleep and daytime tiredness.
Scale 5 measures the severity of RLS symptoms during the last seven days engaged in activities on an 11-point scale that ranges between 0 (none) to 10 (very severe). The ratings are given by the subjects.
A negative value in Change from Baseline indicates an improvement from Baseline."|From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period|Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period.||units on a scale||Standard Deviation|Mean
682688|NCT01537042|Secondary|Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 4 to the End of the Maintenance Period|"The RLS-6 consists of six scales of which four scales are designed to assess severity of RLS and two scales cover sleep and daytime tiredness.
Scale 4 measures the severity of RLS symptoms during the last seven days at rest on an 11-point scale that ranges between 0 (none) to 10 (very severe). The ratings are given by the subjects.
A negative value in Change from Baseline indicates an improvement from Baseline."|From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period|Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period.||units on a scale||Standard Deviation|Mean
682689|NCT01537042|Secondary|Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 3 to the End of the Maintenance Period|"The RLS-6 consists of six scales of which four scales are designed to assess severity of RLS and two scales cover sleep and daytime tiredness.
Scale 3 measures the severity of RLS symptoms during the last seven nights on an 11-point scale that ranges between 0 (none) to 10 (very severe). The ratings are given by the subjects.
A negative value in Change from Baseline indicates an improvement from Baseline."|From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period|Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period.||units on a scale||Standard Deviation|Mean
682690|NCT01537042|Secondary|Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 2 to the End of the Maintenance Period|"The RLS-6 consists of six scales of which four scales are designed to assess severity of RLS and two scales cover sleep and daytime tiredness.
Scale 2 measures the severity of RLS symptoms during the last 7 nights in the situation of falling asleep. This is measured on an 11-point scale that ranges between 0 (none) to 10 (very severe). The ratings are given by the subjects.
A negative value in Change from Baseline indicates an improvement from Baseline."|From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period|Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period.||units on a scale||Standard Deviation|Mean
682691|NCT01537042|Secondary|Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 1 to the End of the Maintenance Period|"The RLS-6 consists of six scales of which four scales are designed to assess severity of RLS and two scales cover sleep and daytime tiredness.
Scale 1 measures satisfaction with sleep during the last seven nights on an 11-point scale that ranges between 0 (completely satisfied) to 10 (completely dissatisfied). The ratings are given by the subjects.
A negative value in Change from Baseline indicates an improvement from Baseline."|From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period|Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period.||units on a scale||Standard Deviation|Mean
682692|NCT01537042|Secondary|Change From Baseline in Clinical Global Impressions (CGI) Item 1 Score|The CGI Item 1 score measures the severity of illness on a scale that ranges from 0 (Not assessed) to 7 (Among the most extremely ill).|Visit 2 (Baseline); Visit 6 (End of Maintence Period)|Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period.||participants|||Number
682693|NCT01537042|Secondary|Change From Baseline in the International Restless Legs Syndrome Study Group Rating Scale (IRLS) Sum Score to the End of the Maintenance Period|"The IRLS is a subject based scale that consists of 10 items to evaluate the severity of major RLS symptoms and the impact of the disease on subjects' functioning in daytime activities. Each of the 10 items is measured on a scale that ranges from 0 (not present) to 4 (severe). A sum score between 0 (no RLS symptoms present at all) and 40 (maximum severity in all symptoms) across all 10 items will be calculated.
A negative value in Change from Baseline indicates an improvement from Baseline in IRLS."|From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period|Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period.||units on a scale||Standard Deviation|Mean
682694|NCT01537042|Secondary|Change From Baseline in the Periodic Limb Movements Index (PLMI) to the End of the Maintenance Period|The PLMI is defined as Periodic Limb Movements (PLMs)/ total time in bed in hours. PLMs are measured by Polysomnography (PSG). A negative value in change from Baseline indicates an improvement from Baseline to the end of the Maintenance Period.|From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period|Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period.||movement/ hour||Standard Deviation|Mean
682695|NCT01537042|Primary|Ratio From Baseline to the End of the 2-week Maintenance Period in Periodic Limb Movement Index (PLMI)|"The PLMI is defined as Periodic Limb Movements (PLMs)/ total time in bed in hours. PLMs are measured by Polysomnography (PSG).
The reduction of the PLMI is reflected in terms of the ratio from Baseline to the end of the Maintenance Period and was calculated as [PLMI at end of Maintenance Period (MP)] / [PLMI at Baseline].
A PLMI Ratio <1 indicates an improvement from Baseline to the end of the 2-week MP."|From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period|Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period.||ratio||95% Confidence Interval|Least Squares Mean
682696|NCT01536951|Primary|Number of Participants With 1 or More Drug-Related Adverse Events (AEs) or Any Serious AEs (SAEs)|The number of participants with treatment-emergent adverse events (TEAEs) or treatment-emergent SAEs considered by the investigator to be related to study drug is reported. A summary of SAEs and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.|Baseline through study completion and 30-day follow-up|Enrolled participants who had at least 1 dose of study drug (LY3009104, moxifloxacin, or placebo) during the study.||Participants|||Count of Participants
682697|NCT01536951|Primary|Pharmacokinetics: Area Under the Concentration Curve From Time 0 to Infinity [AUC(0-inf)] of LY3009104||Parts A and B, Periods 1 through 3: Predose and 0.5 hours (h), 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 12 h, 24 h, 36 h, 48 h after administration of study drug|Randomized participants who received at least 1 dose of LY3009104 and had a predose and at least 1 postdose blood draw for AUC assessment.||hours*nanomoles per liter (h*nmol/L)||Geometric Coefficient of Variation|Geometric Mean
682698|NCT01536951|Primary|Pharmacokinetics: Maximum Concentration (Cmax) of LY3009104||Parts A and B, Periods 1 through 3: Predose and 0.5 hours (h), 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 12 h, 24 h, 36 h, 48 h after administration of study drug|Randomized participants who received at least 1 dose of LY3009104.||nanomoles per liter (nmol/L)||Geometric Coefficient of Variation|Geometric Mean
682699|NCT01536951|Primary|Change From Baseline Through 24 Hours Postdose in Population-Corrected QT (QTcP) Interval|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and is calculated from electrocardiogram (ECG) data. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between 2 R waves. Using the population-corrected formula: QTcP = QT/RR^beta, where beta is the population correction factor computed from a log-linear model (ln) QT = alpha+beta*ln RR fitted to all Day -1 and Day 1 predose QT and RR measurements in all periods for all participants. Baseline is the average of data collected for 2 hours before dosing on Day 1 of each period [-2 hours (h), -1.5 h, -1 h, -0.5 h, and 0 h]. The QTcP interval was not assessed during Part A of the study, as specified in the protocol. The QTcP interval at 1 h, 2 h, and 4 h postdose for moxifloxacin was compared to placebo to establish assay sensitivity.|Part B, Periods 1 through 3: Baseline, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 12 h, and 24 h postdose|Participants enrolled in Part B of the study who had at least 1 dose of study drug (LY3009104, moxifloxacin, or placebo).||milliseconds (msec)||Standard Deviation|Mean
682700|NCT01536938|Primary|Subjects With ‘Controlled Disease’ (‘Clear’/‘Almost Clear’ for Subjects w. at Least Moderate Disease at Baseline, ‘Clear’ for Subjects With Mild Disease at Baseline) According to the Investigator’s Global Assessment (IGA) on the Trunk and Limbs at Week 4.|Assessment of disease severity (Plaque thickening, Scaling and Erythema) using a 5-point scale (Clear, Almost clear, Mild, Moderate, Severe), based on the condition of the disease at the time of evaluation.|4 weeks|||participants|||Number
682701|NCT01536886|Primary|Subjects With ‘Controlled Disease’ (‘Clear’/‘Almost Clear’ for Subjects w. at Least Moderate Disease at Baseline, ‘Clear’ for Subjects With Mild Disease at Baseline) According to the Investigator’s Global Assessment (IGA) on the Trunk and Limbs at Week 4.|Assessment of disease severity (Plaque thickening, Scaling and Erythema) using a 5-point scale (Clear, Almost clear, Mild, Moderate, Severe), based on the condition of the disease at the time of evaluation.|4 weeks|||participants|||Number
682702|NCT01536860|Primary|Glycemic Response Measured as the Positive Incremental Area Under the Time-concentration Curve(iAUC) Calculated From Individual Glucose Measurements Upon Consumption of Control and Experimental Test Food Products|The individual glucose measurements were collected at baseline (prior to consumption of each test food product and 15, 30, 45, 60, 90 and 120 minutes following the initiation of consumption of each test food product. The positive incremental area under the time-concentration curve (iAUC) was then calculated for the entire 120 minutes after consumption of each test food product. The results show the differential treatment-related effect on the time-concentration curve (iAUC) for the entire 120 minutes post consumption of each test food product.|0-120 minutes|||mmol*min/L||Standard Error|Mean
682703|NCT01536704|Secondary|Elimination Rate Constant for Plasma Nicotine: K (el)|Kel was calculated with the help of plasma time concentration values.|Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours|Analysis was done per intention to treat (ITT) population.||1/hr||Full Range|Median
682704|NCT01536704|Secondary|Apparent Elimination Half-life of Nicotine T(1/2)|T(1/2) was calculated using plasma time-concentration values.|Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours|Analysis was done per intention to treat (ITT) population.||hr||Full Range|Median
682705|NCT01536704|Secondary|Time to Reach Maximum Plasma Nicotine Concentration (Tmax)|Tmax was time at which Cmax of nicotine was reached.|Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours|Analysis was done per intention to treat (ITT) population.||hr||Full Range|Median
682706|NCT01536704|Secondary|AUC [0-infinity (Inf)]|AUC (0-inf) was evaluated using the trapezoid rule.|Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours|Analysis was done per intention to treat (ITT) population.||ng.hr/mL||Standard Deviation|Mean
682707|NCT01536704|Primary|Maximum Observed Plasma Concentration [Cmaximum (Max)]|Cmax was depicted from plasma concentration of nicotine.|Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours|Analysis was done per intention to treat (ITT) population.||ng/mL||Standard Deviation|Mean
682708|NCT01536704|Primary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to Time t [AUC(0-t)]|AUC(0-t) was evaluated using the trapezoid rule.|Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours|Analysis was done per intention to treat (ITT) population.||nanogram (ng).hour (hr)/millilitre (mL)||Standard Deviation|Mean
682709|NCT01536587|Secondary|Arterial Stiffness at Baseline (Week 0) and at Week 4|Arterial stiffness occurs as a consequence of age and arteriosclerosis. Carotid-femoral pulse wave velocity (PWV), a measure of arterial stiffness, is determined from the time taken for the arterial pulse to propagate from the carotid to the femoral artery. PWV was evaluated in terms of meters per second (m/s). PWV after salmeterol inhalation at Baseline (Week 0, [Visit 1, before any inhalation]) and at Week 4 (Visit 2, after inhalation of salmeterol) was assessed.|Baseline and Week 4|ITT Population. Only those participants available at the specified time points were assessed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||m/s||Standard Deviation|Mean
682710|NCT01536587|Secondary|Number of Participants With Diastolic Dysfunction on Echocardiography at Baseline (Week 0) and at Week 4|Diastolic dysfunction refers to the decline in performance of one (usually the left ventricle) or both (left and right) ventricles during diastole. The number of participants with diastolic dysfunction on echocardiography was evaluated at Baseline (Week 0, [Visit 1, before any inhalation]) and at Week 4 (Visit 2, after salmeterol inhalation).|Baseline and Week 4|ITT Population. Only those participants available at the indicated time points were assessed.||participants|||Number
682753|NCT01536561|Secondary|Time to Nadir for the Indicated Hematologic Laboratory Parameters|Nadir is defined as the lowest laboratory value recorded following the administration of the study medication.|Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.|ITT Exposed Population. Only those participants for which nadir could be calculated were analyzed. Some participants did not have post-baseline data available.||days||Full Range|Median
682711|NCT01536587|Secondary|Lung Function (Forced Vital Capacity [FVC], Functional Residual Capacity [FRC; Body and Helium], Total Lung Capacity [TLC], and Residual Volume [RV]) at Baseline (Week 0) and at Week 4|FVC is defined as the volume of air that can be forcibly blown out from the lungs after a full inspiration. FRC is defined as the volume of air present in the lungs, specifically the parenchyma tissues, at the end of a passive expiration. TLC is defined as the maximum volume to which the lungs can be expanded with the greatest possible inspiratory effort; it is equal to VC plus the RV and is approximately 5800 milliliters. RV is defined as the amount of gas remaining in the lungs at the end of a maximal exhalation. All parameters describing lung function are expressed in terms of liters (L). Lung function (FVC, FRC [body and helium], TLC, and RV) was evaluated at Baseline (Week 0, [Visit 1, before any inhalation]) and at Week 4 (Visit 2, after salmeterol inhalation).|Baseline and Week 4|ITT Population. Only those participants available at the indicated time points were assessed.||L||Standard Deviation|Mean
682712|NCT01536587|Secondary|Change From Baseline in Transcutaneous Carbon Dioxide (tCO2) at 2 Hours (Week 0) and at Week 4|Transcutaneous carbon dioxide monitoring is a noninvasive way of continuously measuring the tension of these gases in the skin. This methodology provides a continuous noninvasive estimation of the arterial CO2 value. Change in tCO2 after salmeterol inhalation is expressed in terms of millimeters of mercury (mmHg). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|Safety Population. Only those participants available at the indicated time points were assessed.||mmHg||Standard Deviation|Mean
682713|NCT01536587|Secondary|Change From Baseline in Oxygen Saturation Measured Via Pulse Oxymetry (SpO2) at 2 Hours (Week 0) and at Week 4|Oxygen saturation measures the capacity of blood to transport oxygen to other parts of the body. Oxygen binds to hemoglobin in red blood cells when moving through the lungs. A pulse oximeter uses two frequencies of light (red and infrared) to determine the percentage of hemoglobin in the blood that is saturated with oxygen. The percentage is called blood oxygen saturation, or SpO2. Change in SpO2 after salmeterol inhalation is expressed in terms of percent. Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|Safety Population: all participants included in the study who received at least one dose of study medication. Only those participants available at the indicated time points were assessed.||percent||Standard Deviation|Mean
682714|NCT01536587|Secondary|Change From Baseline in Catecholamines (Brain Natriuretic Peptide [BNP]) at 2 Hours (Week 0) and at Week 4|Catecholamines are important neurotransmitters in the central nervous system and play a crucial role in the autonomic regulation of many homeostatic functions. Change in catecholamines (BNP) after salmeterol inhalation is expressed in terms of picograms per milliliter (pg/mL). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT Population. Only those participants available at the indicated time points were assessed.||pg/mL||Standard Deviation|Mean
682715|NCT01536587|Secondary|Change From Baseline in Catecholamines (Plasma Epinephrine) at 2 Hours (Week 0) and at Week 4|Catecholamines are important neurotransmitters in the central nervous system and play a crucial role in the autonomic regulation of many homeostatic functions. Change in catecholamines (plasma epinephrine) after salmeterol inhalation is expressed in terms of nanograms per milliliter (ng/mL). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT Population. Only those participants available at the specified time points were assessed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||ng/mL||Standard Deviation|Mean
682716|NCT01536587|Secondary|Change From Baseline in Catecholamines (Plasma Norepinephrine) at 2 Hours (Week 0) and at Week 4|Catecholamines are important neurotransmitters in the central nervous system and play a crucial role in the autonomic regulation of many homeostatic functions. Change in catecholamines (plasma norepinephrine) after salmeterol inhalation is expressed in terms of nanogramms per liter (ng/L). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT Population. Only those participants available at the specified time points were assessed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||ng/L||Standard Deviation|Mean
682717|NCT01536587|Secondary|Change From Baseline in Respiratory Minute Volume at 2 Hours (Week 0) and at Week 4|Respiratory minute volume is defined as the volume of gas inhaled (inhaled minute volume) or exhaled (exhaled minute volume) from a person's lungs per minute. Change in respiratory minute volume after salmeterol inhalation is expressed in terms of milliliters per minute (mL/min). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT Population. Only those participants available at the specified time points were assessed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||mL/min||Standard Deviation|Mean
682751|NCT01536561|Secondary|Nadir Values for the Hematologic Parameters ANC, Platelets, and WBC Count|Nadir is defined as the lowest laboratory value recorded following the administration of study medication. ANC is a measure of the number of neutrophil granulocytes present in the blood. Neutrophils are a type of WBC that fights against infection. Platelets and WBCs are types of blood cells.|Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.|ITT Exposed Population. Only those participants for which nadir could be calculated were analyzed. Some participants did not have post-baseline data available.||1000 cells/millimeters cubed (mm^3)||Full Range|Median
682718|NCT01536587|Secondary|Change From Baseline in Tidal Volume at 2 Hours (Week 0) and at Week 4|Tidal volume is defined as the lung volume representing the normal volume of air displaced between normal inspiration and expiration when extra effort is not applied (normal value is approximately 500 milliliters or 7 milliliters per kilogram of body weight). Change in tidal volume after salmeterol inhalation is expressed in terms of milliliters (mL). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT Population. Only those participants available at the specified time points were assessed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||mL||Standard Deviation|Mean
682719|NCT01536587|Secondary|Change From Baseline in Respiratory Rate at 2 Hours (Week 0) and at Week 4|Respiratory rate is defined as the number of breaths taken within a set amount of time (typically within 60 seconds). Change in respiratory rate after salmeterol inhalation is expressed in terms of respiratory rate (breaths) per minute (min). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT Population. Only those participants available at the indicated time points were assessed.||breaths per minute||Standard Deviation|Mean
682720|NCT01536587|Secondary|Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at 2 Hours (Week 0) and at Week 4|Systolic and diastolic BP was manually measured. Change in BP after salmeterol inhalation is expressed in terms of millimeters of mercury (mmHg). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT Population. Only those participants available at the indicated time points were assessed.||mmHg||Standard Deviation|Mean
682721|NCT01536587|Secondary|Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at 2 Hours (Week 0) and at Week 4 (ITT-MSNA Population)|Pulmonary function was measured by FEV1, defined as the volume of air that which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change in FEV1 after salmeterol inhalation is expressed in terms of liters (L). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT-MSNA Population. Only those participants available at the indicated time points were assessed.||L||Standard Deviation|Mean
682722|NCT01536587|Secondary|Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at 2 Hours (Week 0) and at Week 4 (ITT Population)|Pulmonary function was measured by FEV1, defined as the volume of air that which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change in FEV1 after salmeterol inhalation is expressed in terms of liters (L). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT Population. Only those participants available at the indicated time points were assessed.||L||Standard Deviation|Mean
682723|NCT01536587|Secondary|Change From Baseline in Spontaneous Baroreflex Sensitivity (BRS) at 2 Hours (Week 0) and at Week 4 (ITT-MSNA Population)|BRS is an important characteristic of baroreflex control and is often noninvasively assessed by relating heart rate (HR) fluctuations to blood pressure (BP) fluctuations. Change in BRS after salmeterol inhalation is expressed in terms of milliseconds per millimeters of mercury (ms/mmHg). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0 before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT-MSNA Population. Only those participants available at the indicated time points were assessed.||ms/mmHg||Standard Deviation|Mean
682724|NCT01536587|Secondary|Change From Baseline in Spontaneous Baroreflex Sensitivity (BRS) at 2 Hours (Week 0) and at Week 4 (ITT Population)|BRS is an important characteristic of baroreflex control and is often noninvasively assessed by relating heart rate (HR) fluctuations to blood pressure (BP) fluctuations. Change in BRS after salmeterol inhalation is expressed in terms of milliseconds per millimeters of mercury (ms/mmHg). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0 before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT Population. Only those participants available at the specified time points were assessed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||ms/mmHg||Standard Deviation|Mean
682725|NCT01536587|Secondary|Change From Baseline in Heart Rate Variability (HRV): Heart Rate at 2 Hours (Week 0) and at Week 4 (ITT-MSNA Population)|Heart rate refers to the speed of the heartbeat, specifically the number of heartbeats per unit of time. Change in HRV (heart rate) after salmeterol inhalation is expressed in terms of the heart rate (beats) per minute (heart rate/min). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0 before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT-MSNA Population||beats per minute (bpm)||Standard Deviation|Mean
682726|NCT01536587|Secondary|Change From Baseline in Heart Rate Variability (HRV): Heart Rate at 2 Hours (Week 0) and at Week 4 (ITT Population)|Heart rate refers to the speed of the heartbeat, specifically the number of heartbeats per unit of time. Change in HRV (heart rate) after salmeterol inhalation is expressed in terms of the heart rate (beats) per minute (heart rate/min). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0 before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT Population. Only those participants available at the indicated time points were assessed.||beats per minute (bpm)||Standard Deviation|Mean
682910|NCT01536067|Primary|Overall Response Rate (CR + PR + MR) of Ofatumumab in Combination With Bortezomib|Assessed using the Consensus Panel recommendations from the Third International Workshop on Waldenstrom Macroglobulinemia.|Every 28 days|Due to the study's early termination and low accrual, data were not collected for this assessment.|||||
682727|NCT01536587|Secondary|Change From Baseline in Heart Rate Variability (HRV): Normalized High Frequency Power (HF) at 2 Hours (Week 0) and at Week 4 (ITT-MSNA Population)|HRV refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. HRV frequencies can be analyzed with frequency domain methods: the HF component of the HRV spectrum reflects parasympathetic activity. Change in HRV (normalized HF) after salmeterol inhalation is expressed in terms of normalized units that represent the relative value of HF power component in proportion to the total power minus the very LF (VLF) component (HF/(Total Power–VLF)*100). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT-MSNA Population||percent change||Standard Deviation|Mean
682728|NCT01536587|Secondary|Change From Baseline in Heart Rate Variability (HRV): Normalized High Frequency (HF) Power at 2 Hours (Week 0) and at Week 4 (ITT Population)|HRV refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. HRV frequencies can be analyzed with frequency domain methods: the HF component of the HRV spectrum reflects parasympathetic activity. Change in HRV (normalized HF) after salmeterol inhalation is expressed in terms of normalized units that represent the relative value of HF power component in proportion to the total power minus the very LF (VLF) component (HF/(Total Power–VLF)*100). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT Population. Only those participants available at the indicated time points were assessed.||percent change||Standard Deviation|Mean
682729|NCT01536587|Secondary|Change From Baseline in Heart Rate Variability (HRV): Normalized Low Frequency (LF) Power at 2 Hours (Week 0) and at Week 4 (ITT-MSNA Population)|HRV refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. HRV frequencies can be analyzed with frequency domain methods: The LF component of the HRV spectrum reflects sympathetic activity. Change in HRV (normalized LF) after salmeterol inhalation is expressed in terms of normalized units that represent the relative value of LF power component in proportion to the total power minus the very LF (VLF) component (LF/(Total Power–VLF)*100). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT-MSNA Population||percent change||Standard Deviation|Mean
682730|NCT01536587|Secondary|Change From Baseline in Heart Rate Variability (HRV): Normalized Low Frequency (LF) Power at 2 Hours (Week 0) and at Week 4 (ITT Population)|HRV refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. HRV frequencies can be analyzed with frequency domain methods: the LF component of the HRV spectrum reflects sympathetic activity. Change in HRV (normalized LF) after salmeterol inhalation is expressed in terms of normalized units that represent the relative value of LF power component in proportion to the total power minus the very LF (VLF) component (LF/(Total Power–VLF)*100). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT Population. Only those participants available at the indicated time points were assessed.||percent change||Standard Deviation|Mean
682731|NCT01536587|Secondary|Change From Baseline in Heart Rate Variability (HRV): Absolute High Frequency (HF) Power at 2 Hours (Week 0) and at Week 4 (ITT-MSNA Population)|HRV refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. HRV frequencies can be analyzed with frequency domain methods: the HF component of the HRV spectrum reflects parasympathetic activity. Change in HRV (absolute HF) after salmeterol inhalation is expressed in terms of milliseconds squared (ms^2). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT-MSNA Population||ms^2||Standard Deviation|Mean
682732|NCT01536587|Secondary|Change From Baseline in Heart Rate Variability (HRV): Absolute High Frequency (HF) Power at 2 Hours (Week 0) and at Week 4 (ITT Population)|HRV refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. HRV frequencies can be analyzed with frequency domain methods: the HF component of the HRV spectrum reflects parasympathetic activity. Change in HRV (absolute HF) after salmeterol inhalation is expressed in terms of milliseconds squared (ms^2). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT Population. Only those participants available at the indicated time points were assessed.||ms^2||Standard Deviation|Mean
682733|NCT01536587|Secondary|Change From Baseline in Heart Rate Variability (HRV): Absolute Low Frequency (LF) Power at 2 Hours (Week 0) and at Week 4 (ITT-MSNA Population)|HRV refers to the complex beat-to-beat (N-N) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. HRV frequencies can be analyzed with frequency domain methods: The LF component of the HRV spectrum reflects sympathetic activity. Change in HRV (absolute LF) after salmeterol inhalation is expressed in terms of milliseconds squared (ms2). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation), respectively.|Baseline, 2 hours (Week 0), and Week 4|ITT-MSNA Population||ms^2||Standard Deviation|Mean
682805|NCT01536405|Primary|Geometric Mean Titer (GMT) of VZV Antibodies|Sera were tested for VZV IgG antibody levels by gpELISA|Six weeks after vaccination 1|The per protocol population included participants who received >=1 dose of study vaccine, were seronegative at baseline and had postvaccination VZV serology results||ELISA units/mL||95% Confidence Interval|Geometric Mean
682734|NCT01536587|Secondary|Change From Baseline in Heart Rate Variability (HRV): Absolute Low Frequency (LF) Power at 2 Hours (Week 0) and at Week 4 (ITT Population)|HRV refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. HRV frequencies can be analyzed with frequency domain methods: the LF component of the HRV spectrum reflects sympathetic activity. Change in HRV (absolute LF) after salmeterol inhalation is expressed in terms of milliseconds squared (ms^2). Change from Baseline were calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT Population. Only those participants available at the indicated time points were assessed.||ms^2||Standard Deviation|Mean
682735|NCT01536587|Secondary|Change From Baseline in Heart Rate Variability (HRV): Square Root of the Mean Squared Difference of Successive NNs (RMSSD) at 2 Hours (Week 0) and at Week 4 (ITT-MSNA Population)|HRV refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. Compared with SDNN, RMSSD is a short-term variation of heart rate. Change in HRV (RMSSD) after salmeterol inhalation is expressed in terms of milliseconds (ms). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT-MSNA Population||ms||Standard Deviation|Mean
682736|NCT01536587|Secondary|Change From Baseline in Heart Rate Variability (HRV): Square Root of the Mean Squared Difference of Successive NNs (RMSSD) at 2 Hours (Week 0) and at Week 4 (ITT Population)|HRV refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. Compared with SDNN, RMSSD is a short-term variation of heart rate. Change in HRV (RMSSD) after salmeterol inhalation is expressed in terms of milliseconds (ms). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT Population. Only those participants available at the indicated time points were assessed.||ms||Standard Deviation|Mean
682737|NCT01536587|Secondary|Change From Baseline in Heart Rate Variability (HRV): Standard Deviation of NN Intervals (SDNN) at 2 Hours (Week 0) and at Week 4 (ITT-MSNA Population)|HRV refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. SDNN reflects all the cyclic components responsible for variability in the period of recording; therefore, it represents total variability. Change in HRV (SDNN) after salmeterol inhalation is expressed in terms of milliseconds (ms). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT-MSNA Population||ms||Standard Deviation|Mean
682738|NCT01536587|Secondary|Change From Baseline in Heart Rate Variability (HRV): Standard Deviation of NN Intervals (SDNN) at 2 Hours (Week 0) and at Week 4 (ITT Population)|Heart rate variability (HRV) refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. SDNN reflects all the cyclic components responsible for variability in the period of recording; therefore, it represents total variability. Change in HRV (SDNN) after salmeterol inhalation is expressed in terms of milliseconds (ms). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT Population. Only those participants available at the indicated time points were assessed.||ms||Standard Deviation|Mean
682739|NCT01536587|Secondary|Change From Baseline in MSNA (Evaluated by Microneurography as Bursts/Minute) at Week 4|Human MSNA is composed of vasoconstrictor impulses grouped in pulse synchronous bursts that usually occur in sequences, preferentially during transient reductions of blood pressure. Sympathetic activity was measured using microneurographic recordings of efferent in the peroneal nerve. MSNA reflects sympathetic discharge to the vascular bed of the skeletal muscle. Change in MSNA is expressed in terms of bursts per minute (bursts/minute). Change from Baseline was calculated as the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline and Week 4|ITT-MSNA Population. Only those participants available at the indicated time points were assessed.||Bursts/minute||Standard Deviation|Mean
682740|NCT01536587|Secondary|Change From Baseline in MSNA (Evaluated by Microneurography as Bursts/Minute) at 2 Hours (Week 0)|Human MSNA is composed of vasoconstrictor impulses grouped in pulse synchronous bursts that usually occur in sequences, preferentially during transient reductions of blood pressure. Sympathetic activity was measured using microneurographic recordings of efferent in the peroneal nerve. MSNA reflects sympathetic discharge to the vascular bed of the skeletal muscle. The change in MSNA (bursts per minute [bursts/minute]) was calculated as the difference in MSNA change from Baseline to after the inhalation of salmeterol (2 hours, Week 0, Visit 1) minus the MSNA change from Baseline to after the inhalation of placebo (1 hour, Week 0, Visit 1).|Baseline and 2 hours (Week 0)|ITT-MSNA Population||Bursts/minute||Standard Deviation|Mean
682741|NCT01536587|Secondary|Change From Baseline in MSNA (Evaluated by Microneurography as Bursts/100 Heart Beats) at Week 4|Human MSNA is composed of vasoconstrictor impulses grouped in pulse synchronous bursts that usually occur in sequences, preferentially during transient reductions of blood pressure. Sympathetic activity was measured using microneurographic recordings of efferent in the peroneal nerve. MSNA reflects sympathetic discharge to the vascular bed of the skeletal muscle. Change in MSNA is expressed in terms of bursts per 100 heart beats (bursts/100 heart beats). Change from Baseline was calculated as the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline and Week 4|ITT-MSNA Population. Only those participants available at the indicated time points were assessed.||Bursts/100 heart beats||Standard Deviation|Mean
682806|NCT01536405|Primary|Percentage of Participants With Rubella Virus Antibody Levels >=10 International Units/mL (IU/mL)|Sera were tested for rubella virus IgG antibody levels by an ELISA|Six weeks after vaccination 1|The per protocol population included participants who received >=1 dose of study vaccine, were seronegative at baseline and had postvaccination rubella serology results||Percentage of participants||95% Confidence Interval|Number
682742|NCT01536587|Primary|Change in Muscle Sympathetic Nerve Activity (MSNA) at 2 Hours (Week 0)|Human MSNA is composed of vasoconstrictor impulses grouped in pulse synchronous bursts that usually occur in sequences, preferentially during transient reductions of blood pressure. Sympathetic activity was measured using microneurographic recordings of efferent in the peroneal nerve. MSNA reflects sympathetic discharge to the vascular bed of the skeletal muscle. The change in MSNA (bursts per 100 heart beats [bursts/100 heart beats]) was calculated as the difference in MSNA change from Baseline to after the inhalation of salmeterol (2 hours, Week 0, Visit 1) minus the MSNA change from Baseline to after the inhalation of placebo (1 hour, Week 0, Visit 1).|Baseline and 2 hours (Week 0)|ITT-MSNA Population: all participants who received at least one dose of study medication and who had a valid data registration period of the primary endpoint.||Bursts/100 heart beats||Standard Deviation|Mean
682743|NCT01536574|Secondary|Mean Change From Baseline in the Gambling Symptom Assessment Scale (G-SAS) Score at Week 24|The G-SAS is a reliable and valid self-reported measure of gambling symptoms. It is comprised of twelve questions aimed at evaluating gambling symptoms; each item is scored on a 5-point scale from 0 (no symptoms) to 4 (extreme symptoms). The total score ranges from 0 to 48, where 0=least severe and 48=most severe. Change from Baseline is calculated as the value at Week 24 minus the Baseline value.|Baseline and Week 24|Safety Population. Only those participants contributing data at the indicated time points were analyzed. Data were collected using the LOCF method.||Scores on a scale||Standard Deviation|Mean
682744|NCT01536574|Secondary|Mean Gambling Symptom Assessment Scale (G-SAS) Score at Week 24|The G-SAS is a reliable and valid self-reported measure of gambling symptoms. It is comprised of twelve questions aimed at evaluating gambling symptoms; each item is scored on a 5-point scale from 0 (no symptoms) to 4 (extreme symptoms). The total score ranges from 0 to 48, where 0=least severe and 48=most severe.|Week 24|Safety Population. Only those participants contributing data at the indicated time points were analyzed. Data were collected using the last observation carried forward (LOCF) method: the last available on-therapy observation for a participant was used to estimate missing data points.||Scores on a scale||Standard Deviation|Mean
682745|NCT01536574|Primary|Number of Participants With the Indicated Adverse Events Related to Investigational Product During the Follow-up Phase|An adverse event is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The Investigator determined if an AE/SAE was related to investigational product. In addition to the data recorded at the follow-up visit, SAEs occurring up to and including 2 days after the last dose of down-titration medication are included in the Follow-up Phase.|4- to 14-day Follow-up Phase, beginning after the date of the last dose of down-titration medication (up to and during Study Weeks 26 and 27)|Safety Population||Participants|||Number
682746|NCT01536574|Primary|Number of Participants With the Indicated Adverse Events During the Follow-up Phase|An adverse event is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. In addition to the data recorded at the follow-up visit, SAEs occurring up to and including 2 days after the last dose of down-titration medication are included in the Follow-up Phase.|4- to 14-day Follow-up Phase, beginning after the date of the last dose of down-titration medication (up to and during Study Weeks 26 and 27)|Safety Population||Participants|||Number
682747|NCT01536574|Primary|Number of Participants With an Adverse Event During the Follow-up Phase|AE=any untoward medical occurrence (UMO), temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. SAE=any UMO that, at any dose, results in death, is life threatening, requires hospitalization/prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomoly/birth defect. The Investigator determined if an AE/SAE was related to investigational product. Medical/scientific judgment was used to determine whether SAE reporting was appropriate in situations in which an event may not have met the SAE definition.|4- to 14-day Follow-up Phase, beginning after the date of the last dose of down-titration medication (up to and during Study Weeks 26 and 27)|Safety Population||Participants|||Number
682748|NCT01536574|Primary|Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase|An adverse event is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The Investigator determined if an AE/SAE was related to investigational product. The On-Treatment Phase is comprised of the Open-label Treatment Phase and the Down-titration Phase.|From the start of treatment (Baseline) up to Week 25|Safety Population||Participants|||Number
682749|NCT01536574|Primary|Number of Participants With the Indicated Types of Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-Treatment Phase (Comprised of the Open-label Treatment Phase and the Down-titration Phase)|AE=any untoward medical occurrence (UMO), temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. SAE=any UMO that, at any dose, results in death, is life threatening, requires hospitalization/prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomoly/birth defect. The Investigator determined if an AE/SAE was related to investigational product. Medical/scientific judgment was used to determine whether SAE reporting was appropriate in situations in which an event may not have met the SAE definition.|From the start of treatment (Baseline) up to Week 25|Safety Population: all participants who received at least one dose of study drug||Participants|||Number
682750|NCT01536561|Secondary|Nadir Values for Hemoglobin, a Hematologic Parameter|Nadir is defined as the lowest laboratory value recorded following the administration of study medication. Hemoglobin is the iron-containing oxygen-transport metalloprotein in the red blood cells.|Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.|ITT Exposed Population||G/dL||Full Range|Median
682752|NCT01536561|Secondary|Time to Recovery to Baseline for the Indicated Hematologic Laboratory Parameters|Time to recovery to baseline is the time required for recovery from nadir values to baseline values.|Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.|ITT Exposed Population. Only those participants for which nadir could be calculated were analyzed. Some participants did not have post-baseline data available.||days||95% Confidence Interval|Median
682754|NCT01536561|Secondary|Number of Participants With the Indicated Type of Infection|An infection is the colonization of a host organism by a parasite species. Infecting parasites seek to use the host's resources to reproduce, often resulting in disease. Specimen samples of the body fluid are cultured for testing whether the infectious organism is present and grown in the culture media to assess the growth pattern of the organisms present in the specimen. The culture results could be positive or negative. The positive culture results indicate that the tested participant has the infection under investigation, in which case therapeutic treatment with anti-infective is required.|Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.|ITT Exposed Population||participants|||Number
682755|NCT01536561|Secondary|Time to HAMA Positivity From the First Dosimetric Dose (Time From Baseline [Dosimetric Dose] to the First Reported Presence of HAMA)|Tositumomab is a murine (mouse) antibody (immunoglobulin) of the IgG2a subclass. Participants in this study were evaluated to determine whether they developed an immune response to study treatment, as evident by human anti-mouse antibodies (HAMA) after administration of tositumomab and iodine I 131 tositumomab. A positive HAMA value indicates that the participant developed human anti-mouse antibodies above the HAMA assay threshold, and a negative HAMA value indicates either the absence or a below threshold level of human anti-mouse antibodies.|Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.|ITT Exposed Population. Participants who converted to HAMA positivity were analyzed.||days||Full Range|Median
682756|NCT01536561|Secondary|Number of Participants Who Developed Human Anti-mouse Antibodies (HAMA Postivitiy) After Receiving Tositumomab|Tositumomab is a murine (mouse) antibody (immunoglobulin) of the IgG2a subclass. Participants in this study were evaluated to determine whether they developed an immune response to study treatment, as evident by human anti-mouse antibodies (HAMA) after administration of tositumomab and iodine I 131 tositumomab. A positive HAMA value indicates that the participant developed human anti-mouse antibodies above the HAMA assay threshold, and a negative HAMA value indicates either the absence or a below threshold level of human anti-mouse antibodies.|Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.|ITT Exposed Population. Only those participants evaluable for HAMA were analyzed.||participants|||Number
682757|NCT01536561|Secondary|Volume of Distribution at Steady State (Vss) of I 131 TST for the Indicated Antibody Predose Levels|Vss is defined as the volume of distribution of the drug at steady state.|Blood samples were collected at the end of the infusion (Study Day 0) and at 0.5, 1, 2, 4, 12, 24, 36, 48, 72, 96, and 120 hours following the end of the infusion|ITT Exposed Population. The sample size (“n”) in the category titles is the number of infusions (dosing occasions) with parameter results.||liters|infusions|Standard Deviation|Mean
682758|NCT01536561|Secondary|Maximum Blood Concentration (Cmax) of I 131 TST for the Indicated Antibody Predose Levels|Cmax is defined as the maximum observed concentration of the drug in blood.|Blood samples were collected at the end of the infusion (Study Day 0) and at 0.5, 1, 2, 4, 12, 24, 36, 48, 72, 96, and 120 hours following the end of the infusion|ITT Exposed Population. The sample size (“n”) in the category titles is the number of infusions (dosing occasions) with parameter results.||% Injected Dose per milliliter (%ID/mL)|infusions|Standard Deviation|Mean
682759|NCT01536561|Secondary|Area Under the Concentration Time Curve (AUC) of I 131 TST for the Indicated Antibody Predose Levels|Area under the concentration-time curve from the end of the infusion extrapolated to infinite time. AUC measures how much drug is in the system over time after infusion. ID, injected dose.|Blood samples were collected at the end of the infusion (Study Day 0) and at 0.5, 1, 2, 4, 12, 24, 36, 48, 72, 96, and 120 hours following the end of the infusion.|ITT Exposed Population. The sample size (“n”) in the category titles is the number of infusions (dosing occasions) with parameter results.||%ID * hours per milliliter (%ID.hr/mL)|infusions|Standard Deviation|Mean
682760|NCT01536561|Secondary|Clearance (CL) of I 131 TST for the Indicated Antibody Predose Levels|Clearance is defined as the volume of blood from which drug is removed per unit time and is a measure of the rate at which drug is removed from the body after the dose.|Blood samples were collected at the end of the infusion (Study Day 0) and at 0.5, 1, 2, 4, 12, 24, 36, 48, 72, 96, and 120 hours following the end of the infusion.|ITT Exposed Population. The sample size (“n”) in the category titles is the number of infusions (dosing occasions) with parameter results.||Milliliters per hour (mL/hr)|infusions|Standard Deviation|Mean
682761|NCT01536561|Secondary|Half-life: Initial Half-life (t1/2 Alpha) and Terminal Half-life (t1/2 Beta) of I 131 TST for the Antibody Predose Levels of 0 mg, 95 mg, and 475 mg|t1/2 alpha is the estimated initial or alpha phase half-life in a two-compartmental pharmacokinetic model . t1/2 beta is the estimated terminal or beta phase half-life in a two-compartmental pharmacokinetic model; also denoted as t1/2. Half-life measures how long it takes for the concentration of drug in the blood to decrease by half.|Blood samples were collected at the end of the infusion (Study Day 0) and at 0.5, 1, 2, 4, 12, 24, 36, 48, 72, 96, and 120 hours following the end of the infusion.|ITT Exposed Population. The sample size (“n”) in the category titles is the number of infusions (dosing occasions) with parameter results.||hours (hr)|infusions|Standard Deviation|Mean
682762|NCT01536561|Secondary|Overall Survival|Overall survival is defined as the time from the treatment start date to the date of death from any cause.|Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.|ITT Exposed Population. Only those participants who died during the study and during the follow-up period were analyzed.||months||95% Confidence Interval|Median
682763|NCT01536561|Secondary|Time to Progression of Disease or Death|Time to progression or progression-free survival is defined as the time from the dosimetric dose to the first documented occurrence of disease progression or death.|Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.|ITT Exposed Population. Only those participants who experienced progression were evaluated.||months||95% Confidence Interval|Median
682764|NCT01536561|Secondary|Duration of Response for All Unconfirmed Responders (CR, CCR, or PR) as Assessed by the Investigator|Duration of response is defined as the time from the first documented response until disease progression.|Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.|ITT Exposed Population. Only those participants with unconfirmed response (CR, CCR, or PR) and those who experienced progressive disease were analyzed.||months||95% Confidence Interval|Median
682765|NCT01536561|Secondary|Number of Participants (Par.) With Confirmed Response as Assessed by the Investigator|Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Par. with confirmed response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).|Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.|ITT Exposed Population. Only those participants evaluable for confirmed response were analyzed.||participants|||Number
682766|NCT01536561|Secondary|Number of Participants (Par.) With the Indicated Response as Assessed by the Investigator|Par. with response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).|Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.|ITT Exposed Population. Only those participants evaluable for response were analyzed.||participants|||Number
682767|NCT01536561|Secondary|Tumor/Organ Dosimetry at the Indicated Predoses of 475 mg, 95 mg, and 0 mg (Initial Treatment)|The effect of unlabeled TST pre-treatment on targeting of radioactive TST was evaluated. Serial whole body sodium iodide scintillation probe counts were obtained from participants approximately 1 hour after the administration of the dosimetric dose (DD) and then daily for at least 5 days. Initially, participants received either two or three DDs, each of which was preceded by a pre-dose of unlabeled tositumomab (0, 95, or 475 mg) to determine the dose of unlabeled tositumomab that optimized the radiation dose to tumor. The tumor radiation absorbed dose was determined using gamma camera images.|Serial anterior and posterior gamma whole body scans were obtained 1 hour after the administration of the dosimetric dose (on Day 0), and then daily for at least 5 days until Day 7|"ITT Exposed Population. Participants who received unlabelled doses of 0 mg, 95 mg, or 475 mg were analyzed. Of the 59 participants analyzed, 23 received 2 or 3 dosimetric doses (DD); tumor/organ dosimetry was calculated for all 86 DD. The n in the category title reflects the number of DD, which will differ for each target organ."||cGy/75 cGy TBD|dosimetric doses|Standard Deviation|Mean
682768|NCT01536561|Primary|Tumor/Organ Dosimetry of TST/I 131 TST for All Predoses (Initial Treatment)|Serial whole body sodium iodide scintillation probe counts were obtained from participants approximately 1 hour after the administration of the dosimetric dose and then daily for at least 5 days. Gamma camera images of participants were used to calculate the amount of radiation that accumulated in the target tumor and normal organs (tumor/organ dosimetry). Spleen volume may vary based on disease status, and volume correction allows for a comparison of spleen dose across participants.|Serial anterior and posterior gamma whole body scans were obtained 1 hour after the administration of the dosimetric dose (on Day 0), and then daily for at least 5 days until Day 7|"ITT Exposed Population. Of the 59 participants analyzed, 23 received 2 or 3 dosimetric doses (DD); tumor/organ dosimetry was calculated for all 86 DD. The n in the category title reflects the number of DD, which will differ for each target organ depending on whether adequate gamma camera images were available for analysis after each of the 86 DD."||cGy/75 cGy TBD|dosimetric doses|Standard Deviation|Mean
682769|NCT01536561|Primary|Maximum Tolerated Dose (MTD) of TST/I 131 TST Evaluated in the Study|Participants who had prior bone marrow transplantation (BMT) initiated TD at 65 cGy TBD, whereas those who had no prior BMT initiated TD at 25 cGy TBD. The MTD was defined as the highest dose level at which 0/3 or 1/6 par. experienced DLT: any Grade 4 hematologic toxicity (National Cancer Institute criteria) lasting >7 days, any Grade 3 hematologic toxicity lasting >2 weeks, or any Grade 3/4 nonhematologic toxicity. Not Applicable (NA) indicates that no par. were re-dosed.|Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.|ITT Exposed Population||Total body radiation dose in cGy|||Number
682770|NCT01536561|Primary|Number of Participants During Retreatment Exposed to the Indicated Dose Levels of the TD, Re-dose, and Total Dose (TD + Re-dose)|Retreatment was administered to participants either at the initial TD of TST/I 131 TST or at a reduced dose if a >=Grade 2 toxicity had occurred after initial treatment, until the MTD was achieved. The MTD was defined as the highest dose level at which 0/3 or 1/6 participants experienced DLT: any Grade 4 hematologic toxicity (National Cancer Institute criteria) lasting >7 days, any Grade 3 hematologic toxicity lasting >2 weeks, or any Grade 3/4 nonhematologic toxicity. Not Applicable (NA) indicates that no participants were re-dosed.|Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.|ITT Exposed Population||participants|||Number
682807|NCT01536405|Primary|Percentage of Participants With Mumps Virus Antibody Levels >=10 Units/mL|Sera were tested for mumps virus IgG antibody levels by an enzyme-linked immunosorbent assay (ELISA)|Six weeks after vaccination 1|The per protocol population included participants who received >=1 dose of study vaccine, were seronegative at baseline and had postvaccination mumps virus serology results||Percentage of participants||95% Confidence Interval|Number
683321|NCT01529385|Primary|Cutaneous Water Content|Cutaneous water content was measured non-invasively by tissue dielectric constant (MoistureMeter) at a single location: 2 inches distal and 2 inches lateral to the fibular head.|change from baseline after 4 weeks of sock usage|||percentage change in dielectric constant||95% Confidence Interval|Mean
682771|NCT01536561|Primary|Number of Participants (Par.) During Initial Treatment Exposed to the Indicated Dose Levels of the Therapeutic Dose (TD), Re-dose, and Total Dose (TD + Re-dose)|Par. (groups of 3-6) received the TD at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (par. who had bone marrow transplantation), increasing by 10 cGy increments at each dose level, until the maximum tolerated dose (MTD) was achieved. The MTD was defined as the highest dose level at which 0/3 or 1/6 par. experienced dose-limiting toxicity (DLT): any Grade 4 hematologic toxicity (National Cancer Institute criteria) lasting >7 days, any Grade 3 hematologic toxicity lasting >2 weeks, or any Grade 3/4 nonhematologic toxicity. Not Applicable (NA) indicates that no par. were re-dosed.|Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.|Intent-to-Treat (ITT) Exposed Population: all participants who were enrolled into the study and received at least one dose of study drug.||participants|||Number
682772|NCT01536496|Secondary|Number of Participants With Multiple Organ Failure (MOF) During This Hospitalization.|Multiple Organ Failure (MOF) score (Denver method) was calculated for the participants. This score rates the dysfunction of four organ systems (pulmonary, renal, hepatic, and cardiac), which are evaluated daily throughout the patient's intensive care unit stay and graded on a scale from 0 to 3, with the total score ranging from 0-12. Higher values on the score represent worse outcome. Participants with score above 3 were considered to have MOF.|Up to 30 days post-injury.|||participants|||Number
682773|NCT01536496|Secondary|Length of Stay (Days) in the Surgical Intensive Care Unit (SICU) Reported as ICU-free Days and Number of Days on the Ventialator Reported as Ventilator Free Days.||28 days.|||days||Inter-Quartile Range|Median
682774|NCT01536496|Secondary|Composition and Quantity of Blood Products Transfused at 24 Hours Post-injury|Amount of blood product (red blood cells, plasma, cryoprecipitate and platelets) in units.|24 hours post-injury|||units||Inter-Quartile Range|Median
682775|NCT01536496|Secondary|Change in r-TEG LY30 Test Results.||Within first 6 hours post-injury, 12 and 24 hours post-injury.|||percent of clot lysis at 30 min.||Inter-Quartile Range|Median
682776|NCT01536496|Secondary|Change in r-TEG Maximal Amplitude (MA) Test Results.||Within first 6 hours post-injury, 12 and 24 hours post-injury.|||mm||Inter-Quartile Range|Median
682777|NCT01536496|Secondary|Change in r-TEG Angle Test Results.||Within first 6 hours post-injury, 12 and 24 hours post-injury.|||degrees||Inter-Quartile Range|Median
682778|NCT01536496|Secondary|Change in r-TEG ACT (Activated Clotting Time) Test Results.||Within first 6 hours post-injury, 12 and 24 hours post-injury.|||seconds||Inter-Quartile Range|Median
682779|NCT01536496|Secondary|Change in D-dimer Test Results.||Within first 6 hours post-injury, 12 and 24 hours post-injury.|||ug/mL||Inter-Quartile Range|Median
682780|NCT01536496|Secondary|Change in Platelet Count Test Results.||Within first 6 hours post-injury, 12 and 24 hours post-injury.|||k/uL||Inter-Quartile Range|Median
682781|NCT01536496|Secondary|Change in Fibrinogen Test Results.||Within first 6 hours post-injury, 12 and 24 hours post-injury.|||mg/dL||Inter-Quartile Range|Median
682782|NCT01536496|Secondary|Change in INR Test Results.|A high International Normalized Ratio (INR) indicates a higher risk of bleeding, while a low INR suggests a higher risk of developing a clot.|Within first 6 hours post-injury, 12 and 24 hours post-injury.|||units on a scale||Inter-Quartile Range|Median
682783|NCT01536496|Secondary|Time to Death From Injury in Hours.||From time of injury to 28th day of hospitalization.|||hours||Inter-Quartile Range|Median
682784|NCT01536496|Secondary|Deaths Related to Coagulopathic Bleeding Based Upon Clinical Impressions of the Treating Surgeons and Review of Operative Records and Outcome (Hours Since Injury).||Up to 28 days post-injury.|||deaths|||Number
682785|NCT01536496|Secondary|Deaths Specified as Early Mortality (<6 Hours Post-injury) and Delayed Mortality (6-24 Hours Post-injury).||Within 24 hours post-injury.|||deaths|||Number
682786|NCT01536496|Primary|28 Day In-hospital Mortality||28 days in hospital|||participants|||Number
682787|NCT01536418|Secondary|Pharmacogenetic Analyses|Sample for the pharmacogenetic analyses was collected during any one of the Treatment Phase visit (Week 2, 4, 6, or 8 ). The pharmacogenetic analyses was planned to perform to investigate the relationship between the genetic markers with the safety and efficacy response to GSK1605786A. These pharmacogenetic analyses was not conducted following the early termination of the study. The study was terminated prematurely due to absence of favorable benefit-to-risk profile of GSK1605786A, and thus data was not collected for this outcome measure.|Post randomization any time during early two weeks|ITT population.|||||
682788|NCT01536418|Secondary|Pharmacokinetics (PK) of GSK1605786A|The PK analyses was planned to perform to characterize the PK of the study drug GSK1605786A, in the participant population. PK is defined as the concentration of drug in a participant’s blood at certain time points after the drug was taken by mouth. PK sampling was to be conducted at week 2, 4, 6 ,8, 10 and week 12 (pre-dose, post-dose 0.5 hour (hr) to 2 hr, 3 to 6 hr, and 6 to 28 hr post-dose. The study was terminated prematurely due to absence of favorable benefit-to-risk profile of GSK1605786A, and thus the data for this outcome measure was not collected.|Baseline (Screening) and Week 12|The PK population consisted of the participants having received investigational product (i.e., participants in the Safety population) and for whom a sample was obtained and analyzed.|||||
682789|NCT01536418|Secondary|Change From Baseline in Faecal Calprotectin at Week 12|Stool samples were planned to be collected for the measurement faecal calprotectin level at Baseline (Screening) and Week 12. Baseline is defined as the measurement at Screening (Day -21 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline. The study was terminated prematurely due to absence of favorable benefit-to-risk profile of GSK1605786A, and thus data for this outcome measure was not collected.|Baseline (Screening) and Week 12|ITT Population.|||||
682790|NCT01536418|Secondary|Change From Baseline in C-reactive Protein Concentration at Weeks 4, 8, and 12|Blood samples were planned to be collected for the measurement of C-reactive protein at Baseline (Screening) and at Weeks 4, 8, and 12. Baseline is defined as the measurement at Screening (Day -21 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time points (Week 4, week 8 and week 12) minus the value at Baseline respectively. The study was terminated prematurely due to absence of favorable benefit-to-risk profile of GSK1605786A, and thus data for this outcome measure was not collected.|Baseline (Screening) and Weeks 4, 8, and Week 12|ITT Population.|||||
682791|NCT01536418|Secondary|Percentage of Participants With a Clinical Response at Week 8 and at Both Week 8 and Week 12|Clinical response, defined as decrease in Crohn’s disease activity index (CDAI) score, from Baseline value of >=100 points. Baseline defined as Week 0. CDAI is scoring system measuring disease severity with scores of >=220 to <=450 describing moderately-to-severely active population(higher score indicated severe disease). Contains 8 questions related to disease symptoms; soft tools in 7 days (weightage (Wt)as 2; abdominal pain over 7 days Wt= 5; general well being Wt= 7;Crohn’s disease symptoms Wt=20; antidiarrhoeal medication used Wt=30; abdominal mass Wt=10; Anemia Wt=10; standard weight with Wt=1.Total CDAI score algorithmically derived from participants-reported above Crohn’s disease symptoms and investigator recorded assessments, calculated by Interactive Voice Response System. Missing efficacy data, imputed using “no effect” imputation where missing was no response or no change in response (were non-responders). If baseline CDAI, < 100,participant was considered non-responder.|Both Week 8 and Week 12|ITT population||Percentage of participants|||Number
682792|NCT01536418|Secondary|Percentage of Participants Achieving Clinical Remission at Week 8, Week 12 and at Both Week 8 and Week 12|Clinical remission is defined as a CDAI score of <150 points. CDAI is scoring system measuring disease severity with scores of >=220 to <=450 describing moderately-to-severely active population(higher score indicated severe disease). Contains 8 questions related to disease symptoms; soft tools in 7 days (weightage (Wt)as 2; abdominal pain over 7 days Wt= 5; general well being Wt= 7;Crohn’s disease symptoms Wt=20; antidiarrhoeal medication used Wt=30; abdominal mass Wt=10; Anemia Wt=10; standard weight with Wt=1.Total CDAI score algorithmically derived from participants-reported above Crohn’s disease symptoms and investigator recorded assessments, calculated by Interactive Voice Response System. Missing efficacy data, imputed using “no effect” imputation where missing was no response or no change in response (were non-responders). If the Baseline value was <150, the participant was not considered to have achieved remission.|Week 8 and Week 12|ITT population||Percentage of participants|||Number
682793|NCT01536418|Primary|Percentage of Participants Achieving Clinical Response at Week 12|Clinical response, defined as decrease in Crohn’s disease activity index (CDAI) score, from Baseline value of >=100 points. Baseline defined as Week 0. CDAI is scoring system measuring disease severity with scores of >=220 to <=450 describing moderately-to-severely active population(higher score indicated severe disease). Contains 8 questions related to disease symptoms; soft tools in 7 days (weightage (Wt)as 2; abdominal pain over 7 days Wt= 5; general well being Wt= 7;Crohn’s disease symptoms Wt=20; antidiarrhoeal medication used Wt=30; abdominal mass Wt=10; Anemia Wt=10; standard weight with Wt=1.Total CDAI score algorithmically derived from participants-reported above Crohn’s disease symptoms and investigator recorded assessments, calculated by Interactive Voice Response System. Missing efficacy data, imputed using “no effect” imputation where missing was no response or no change in response (were non-responders). If baseline CDAI, < 100,participant was considered non-responder.|At Week 12|The Intent-to-Treat (ITT) population comprised of all participants who have satisfied the eligibility criteria and were assigned with study medication.||Percentage of participants|||Number
682794|NCT01536405|Secondary|Percentage of Participants With an Injection-site Adverse Event|An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Injection-site AEs reported were solicited with a Vaccine Report Card.|Up to 5 days after each vaccination|The population analyzed included participants who received >=1 study vaccination and had follow-up safety data||Percentage of participants|||Number
682795|NCT01536405|Secondary|Percentage of Participants With Varicella-like Rash||Up to 42 days after each vaccination|The population analyzed included participants who received >=1 study vaccination and had follow-up safety data||Percentage of participants|||Number
682796|NCT01536405|Secondary|Percentage of Participants With Rubella-like Rash||Up to 42 days after each vaccination|The population analyzed included participants who received >=1 study vaccination and had follow-up safety data||Percentage of participants|||Number
682797|NCT01536405|Secondary|Percentage of Participants With Measles-like Rash||Up to 42 days after each vaccination|The population analyzed included participants who received >=1 study vaccination and had follow-up safety data||Percentage of participants|||Number
682798|NCT01536405|Secondary|Percentage of Participants With Mumps-like Symptoms||Up to 42 days after each vaccination|The population analyzed included participants who received >=1 study vaccination and had follow-up safety data||Percentage of participants|||Number
682799|NCT01536405|Secondary|Percentage of Participants With Zoster-like Rash||Up to 42 days after each vaccination|The population analyzed included participants who received >=1 study vaccination and had follow-up safety data||Percentage of participants|||Number
682800|NCT01536405|Secondary|Percentage of Participants With Fever (>=102.2°F [39.0°C] or Oral Equivalent)||Up to 42 days after each vaccination|The population analyzed included participants who received >=1 study vaccination and had follow-up safety data||Percentage of participants|||Number
682801|NCT01536405|Primary|Percentage of Participants With Fever (>=102.2°F [39.0°C] or Oral Equivalent)||Up to 5 days after vaccination 1|The population analyzed included participants who received >=1 study vaccination and had follow-up safety data||Percentage of participants|||Number
682802|NCT01536405|Primary|Geometric Mean Titer (GMT) of Rubella Virus Antibodies|Sera were tested for rubella virus IgG antibody levels by ELISA|Six weeks after vaccination 1|The per protocol population included participants who received >=1 dose of study vaccine, were seronegative at baseline and had postvaccination rubella virus serology results||IU/mL||95% Confidence Interval|Geometric Mean
682803|NCT01536405|Primary|Geometric Mean Titer (GMT) of Mumps Virus Antibodies|Sera were tested for mumps virus IgG antibody levels by ELISA|Six weeks after vaccination 1|The per protocol population included participants who received >=1 dose of study vaccine, were seronegative at baseline and had postvaccination mumps virus serology results||Mumps Ab units/mL||95% Confidence Interval|Geometric Mean
682804|NCT01536405|Primary|Geometric Mean Titer (GMT) of Measles Virus Antibodies|Sera were tested for measles virus IgG antibody levels by ELISA|Six weeks after vaccination 1|The per protocol population included participants who received >=1 dose of study vaccine, were seronegative at baseline and had postvaccination measles virus serology results||mIU/mL||95% Confidence Interval|Geometric Mean
682808|NCT01536405|Primary|Percentage of Participants With Measles Virus Antibody Levels >=255 mIU/mL|Sera were tested for measles virus IgG antibody levels by an ELISA|Six weeks after vaccination 1|The per protocol population included participants who received >=1 dose of study vaccine, were seronegative at baseline and had postvaccination measles virus serology results||Percentage of participants||95% Confidence Interval|Number
682809|NCT01536405|Primary|Percentage of Participants With Varicella Zoster Virus (VZV) Antibody Levels >=5 gpELISA Units/mL|Sera were tested for VZV Immunoglobulin (IgG) antibody levels by a glycoprotein enzyme-linked immunosorbent assay (gpELISA)|Six weeks after vaccination 1|The per protocol population included participants who received >=1 dose of study vaccine, were seronegative at baseline and had postvaccination VZV serology results||Percentage of participants||95% Confidence Interval|Number
682810|NCT01536379|Secondary|Mean Prednisolone Use at Week 24|Adjusted mean difference (treatment-placebo) for Prednisolone use and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction at Week 24. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments Only those participants available at indicated timepoints were analyzed (represented by n=X, X in the category titles).|Week 24|mITT Population||mg/day||Standard Error|Least Squares Mean
682811|NCT01536379|Secondary|Mean eGFR at Week 24 and Week 52|The estimated glomerular filtration rate (eGFR) were calculated by the abbreviated Modification of Diet in Renal Disease (MDRD) equation. Adjusted mean difference(treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction at Week 24 and Week 52. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the indicated time points were analyzed (represented by n= X, X in the category titles).|Week 24 and Week 52|mITT Population||mL/minute/1.73 square meter (m^2)||Standard Error|Least Squares Mean
682812|NCT01536379|Secondary|Mean Serum Creatinine at Week 24 and Week 52|Adjusted mean difference for serum creatinine values (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction, at Week 24 and Week 52. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Week 24 and Week 52|mITT Population||micromole/L||Standard Error|Least Squares Mean
682813|NCT01536379|Secondary|Proportion of Participants With Episodes of Acute Rejection at Week 24 and Week 52|The endpoint diagnosis was made by a proven biopsy result. Number of rejections only counted once per participant. The proportion of participants with episodes of acute rejection was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Week 24 and Week 52|mITT Population. Participants analyzed had at least one biopsy.||Proportion of participants|||Number
682814|NCT01536379|Secondary|Mean Activated: Regulatory T Cell Ratio at Week 24 and Week 52|Activated: regulatory T cell ratio is Activated T cell CD4+CD25hi CD45RA IL 7Rhi (absolute number)/ Regulatory T cell CD4+CD25hi CD45RA IL 7Rlo (absolute number). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Week 24 and Week 52|mITT Population||Ratio||Standard Error|Least Squares Mean
682815|NCT01536379|Secondary|Regulatory T Cell (%CD4) at Week 24 and Week 52|Regulatory T cell (%CD4) = CD4+ CD25hi IL-7Rlo (% of CD4+). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Week 24 and Week 52|mITT Population||Percentage of Regulatory T cell||Standard Error|Least Squares Mean
682816|NCT01536379|Secondary|Regulatory T Cell Count at Week 24 and Week 52|Regulatory T cell count is CD4+ CD25hi IL-7Rlo (Conc-cells/mL). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Week 24 and Week 52|mITT Population||cells/mL||Standard Error|Least Squares Mean
682817|NCT01536379|Secondary|Activated T Cell Percentage at Week 24 and Week 52|Activated T cell percentage (Codarri)= CD4+ CD25hi CD45RA- IL 7Rhi (% of CD4+). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Week 24 and Week 52|mITT Population||Percentage of activated T cell||Standard Error|Least Squares Mean
682839|NCT01536379|Primary|Change From Baseline in Body Temperature From Baseline at Week 24 and Week 52|Change from Baseline in body temperature was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value at Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 24 and Week 52|mITT Population||Degree Centigrade||Standard Deviation|Mean
682818|NCT01536379|Secondary|Activated T Cell Count at Week 24 and Week 52|A T cell is a type of lymphocyte that plays a central role in cell-mediated immunity. Activated T cell count Codarri is CD4+ CD25hi CD45RA- IL 7Rhi (Conc-cells/mL). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Week 24 and Week 52|mITT Population||cells/mL||Standard Error|Least Squares Mean
682819|NCT01536379|Secondary|Transitional B Cells Percentage at Week 24 and Week 52|Transitional B cell percentage (Newell) is CD19+CD24b+CD38b+IgD+ (%CD19+). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Week 24 and Week 52|mITT Population||Percentage of transitional B cells||Standard Error|Least Squares Mean
682820|NCT01536379|Secondary|Transitional B Cells Count at Week 24 and Week 52|Transitional B cell count (Newell) is CD19+CD24b+CD38b+IgD+ (Conc-cells/mL). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Week 24 and Week 52|mITT Population||cells/mL||Standard Error|Least Squares Mean
682821|NCT01536379|Secondary|Activated Memory B Cells Percentage at Week 24 and Week 52|Activated memory B cell-CD95% percentage is CD19+CD27+CD95+ (%CD19/CD27). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Week 24 and Week 52|mITT Population||Percentage of activated memory B cells||Standard Error|Least Squares Mean
682822|NCT01536379|Secondary|Activated Memory B Cells Count at Week 24 and Week 52|Activated memory B cell-CD95% count is CD19+CD27+CD95 conc-cells/mL. Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Week 24 and Week 52|mITT Population||cells/mL||Standard Error|Least Squares Mean
682823|NCT01536379|Secondary|Median Percent Change From Baseline in Memory B Cell Count at Week 24 and Week 52|Memory B cells are B cell sub-type that are formed within germinal centres following primary infection and are important in generating an accelerated and more robust antibody-mediated immune response in the case of re-infection. Memory B cell count included CD20+CD27+ cells/mm^3. Baseline value used in the analysis was of Day 0 (Day of transplant). Endpoint was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Percent change from Baseline in Memory B cell count was calculated as the value at Week 24 and Week 52 minus the value at Baseline multiplied by 100. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Median Difference and 95% confidence interval of difference obtained using the Hodges-Lehmann method.|Baseline, Week 24 and Week 52|mITT Population||Percent change||Full Range|Median
682824|NCT01536379|Primary|Change From Baseline in Immunoglobulin A (IgA), Immunoglobulin G (IgG) and Immunoglobulin M (IgM) at Week 24 and Week 52|Change from Baseline in immunoglobulins IgA, IgG and IgM was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 24 and Week 52|mITT Population||G/L||Standard Deviation|Mean
682825|NCT01536379|Primary|Change From Baseline in Clinical Chemistry Parameter- Glomerular Filtration Rate (GFR) at Week 24 and Week 52|Change from Baseline in GFR was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 24 and Week 52|mITT Population||milliliter (mL)/Minute (min)||Standard Deviation|Mean
682826|NCT01536379|Primary|Change From Baseline in Clinical Chemistry Parameter- Ca, CO2/Bicar, Gl, K, Na, PhI, U/BUN at Week 24 and Week 52|Clinical chemistry parameters included calcium (Ca), carbon dioxide content/bicarbonate (CO2/Bicar), glucose (Gl), potassium (K), sodium (Na), phosphorus inorganic (PhI), urea/blood urine nitrogen (U/BUN). Endpoint was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 24 and Week 52|mITT Population||Millimole (MMOL)/L||Standard Deviation|Mean
682840|NCT01536379|Primary|Change From Baseline in Heart Rate From Baseline at Week 24 and Week 52|Change from Baseline in heart rate was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value at Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 24 and Week 52|mITT Population||Beats per minute (BPM)||Standard Deviation|Mean
682827|NCT01536379|Primary|Change From Baseline in Clinical Chemistry Parameter- Direct Bilirubin, Total Bilirubin and Creatinine at Week 24 and Week 52|Clinical chemistry parameters included direct bilirubin (DB), total bilirubin (TB) and creatinine (C). Endpoint was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 24 and Week 52|mITT Population||Micromole per Liter (umol/L)||Standard Deviation|Mean
682828|NCT01536379|Primary|Change From Baseline in Clinical Chemistry Parameter- ALP, ALT, AST at Week 24 and Week 52|Clinical chemistry parameter included alkaline phosphatase (ALP), alanine amino Transferase (ALT) and aspartate amino transferase (AST). Endpoint was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 24 and Week 52|mITT Population||International Unit (IU)/L||Standard Deviation|Mean
682829|NCT01536379|Primary|Change From Baseline in Clinical Chemistry Parameter- Albumin at Week 24 and Week 52|Change from Baseline in albumin was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 24 and Week 52|mITT Population||G/L||Standard Deviation|Mean
682830|NCT01536379|Primary|Change From Baseline in Haematology Parameter- Red Blood Cell (RBC) at Week 24 and Week 52|Change from Baseline in RBC was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 24 and Week 52|mITT Population||Tera (TI)/L||Standard Deviation|Mean
682831|NCT01536379|Primary|Change From Baseline in Haematology Parameter- Mean Corposcular Volume (MCV) at Week 24 and Week 52|Change from Baseline in MCV was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 24 and Week 52|mITT Population||Femtoliter (FL)||Standard Deviation|Mean
682832|NCT01536379|Primary|Change From Baseline in Haematology Parameter- Mean Corposcular Hemoglobin (MCH) at Week 24 and Week 52|Change from Baseline in MCH was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 24 and Week 52|mITT Population||Picogram (pg)||Standard Deviation|Mean
682833|NCT01536379|Primary|Change From Baseline in the Hematology Parameter- Hematocrit at Week 24 and Week 52|Endpoint was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 24 and Week 52|mITT Population||Percentage of blood||Standard Deviation|Mean
682834|NCT01536379|Primary|Change From Baseline in the Haematology Parameter- Hemoglobin at Week 24 and Week 52|Change from Baseline in hemoglobin was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 24 and Week 52|mITT Population||Grams per Liter (G/L)||Standard Deviation|Mean
682835|NCT01536379|Primary|Change From Baseline in the Indicated Hematology Parameters at Week 24 and Week 52|Hematology parameters included: basophils (B), eosinophils (E), lymphocytes (L), monocytes (M), total neutrophils (N), platelet count (PC) and white blood cells (WBC). Change from Baseline in haematology parameter was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 24 and Week 52|mITT Population||Gills/Liter (GI/L)||Standard Deviation|Mean
682836|NCT01536379|Primary|Number of Participants Outside the Normal Range (NR) for Body Temperature at Week 24 and Week 52|Number of participants outside the normal range (NR) for body temperature was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Number of participants outside the normal range are summarized by less than (<) normal range and greater than (>) normal range categories at Week 24 and Week 52. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Week 24 and Week 52|mITT Population||Participants|||Number
682837|NCT01536379|Primary|Number of Participants Outside the Normal Range (NR) for Heart Rate at Week 24 and Week 52|Number of participants outside the normal range (NR) for heart rate was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Number of participants outside the normal range are summarized by less than (<) normal range and greater than (>) normal range categories at Week 24 and Week 52. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Week 24 and Week 52|mITT Population||Participants|||Number
682838|NCT01536379|Primary|Number of Participants Outside the Normal Range (NR) for SBP and DBP at Week 24 and Week 52|Number of participants outside the normal range (NR) for SBP and DBP was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Number of participants outside the normal range are summarized by less than (<) normal range and greater than (>) normal range categories at Week 24 and Week 52. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Week 24 and Week 52|mITT Population||Participants|||Number
682841|NCT01536379|Primary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 24 and Week 52|Change from Baseline in SBP and DBP were assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value at Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 24 and Week 52|mITT Population||millimeter of mercury (mmHg)||Standard Deviation|Mean
682842|NCT01536379|Primary|Number of Incidence of All Infections and Serious Infections|All infections included: 1. Opportunistic infections per-clinical assessment, 2. Herpes Zoster, a. Recurrent, b. Disseminated, 3. Sepsis. Opportunistic infections were identified using list of preferred terms as per Medical Dictionary for Regulatory Activities (MedDRA) version 18.1. Any events falling under these preferred terms were adjudicated to determine if criteria was met for an opportunistic infection.|Up to 1 year|mITT Population||Infections|||Number
682843|NCT01536379|Primary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)|Number of participants with AEs, SAEs and AESI are summarized. The On-treatment (OT) phase started on the day and time of receiving the start of the first infusion and ended on the last dose date plus 28 days. The Post-treatment (PT) phase started 29 days after day of last dose up to 1 year. An AE is any untoward medical occurrence, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that at any dose results in, death, is life threatening, Requires hospitalization or prolongation of existing hospitalization, Results in disability/incapacity, Is a congenital anomaly/birth defect or event that but may jeopardize the subject or may require medical or surgical intervention to prevent one of the other outcomes listed. AESI included malignant neoplasms, infusion/anaphylaxis/hypersensitivity reactions, all infections, depression/suicide/self-injury, deaths.|Up to 1 year|mITT Population||Participants|||Number
682844|NCT01536379|Primary|Change From Baseline in naïve B Cells From Baseline to Week 24|Naive B cell is cell that is not exposed to antigen. Naïve B cell count is CD20+CD27 concentration of cells (conc-cell)/cubic millimeter (cumm). Change from Baseline in naïve B cells was calculated as the value at Week 24 minus the value at Baseline. MITT Population consisted of all participants randomized to treatment, who have had taken at least one dose of study. Participants analyzed included those who had data at Week 24 for naïve B cells count (MITT Population). Baseline value used in the analysis was of Day 0 (Day of transplant). Adjusted mean differences (treatment-placebo) and 95% confidence intervals for differences were obtained from mixed-models repeated-measures (MMRM) model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments.|Baseline and Week 24|Modified Intent to treat (MITT) Population||cells/mm^3||Standard Error|Least Squares Mean
682845|NCT01536366|Secondary|AUC0-∞ - Area Under the Plasma Concentration-time Curve From Time 0 to Infinity||pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose.|||ng.h/mL||Standard Deviation|Mean
682846|NCT01536366|Secondary|AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to Last Observed Concentration||pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose.|||ng.h/mL||Standard Deviation|Mean
682847|NCT01536366|Secondary|Tmax - Time of Occurrence of Cmax||pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose.|||hours||Full Range|Median
682848|NCT01536366|Primary|Cmax - Maximum Observed Plasma Concentration||pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose.|||ng/mL||Standard Deviation|Mean
682849|NCT01536262|Secondary|Trough FEV1 Response|"Trough Forced Expiratory Volume in 1 second Response. The trough was defined as the mean of the 1 h pre-dose and 10 min pre-dose measurements after 52 weeks. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.
Note: The Mean presented is the unadjusted mean."|Baseline and 1 h, 10 min pre-dose after 52 weeks|Full analysis set (FAS)||L||Standard Error|Mean
682850|NCT01536262|Secondary|FEV1 AUC0-3h Response|"Forced Expiratory Volume in 1 second Area Under Curve (AUC0-3h) response. FEV1 AUC0-3h was calculated using the trapezoidal rule, divided by the duration (3 h) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.
Note: The Mean presented is the unadjusted mean."|Baseline and 1 h, 10 min pre-dose and 30 min, 1 h, 2 h, 3 h post-dose after 52 weeks|Full analysis set (FAS): This patient set included all randomised patients who received at least 1 dose of treatment and had both non-missing baseline and at least 1 non-missing post-baseline efficacy measurement. Assignment to FAS was done after implementation of any data handling rules which set measurements to missing.||L||Standard Error|Mean
682851|NCT01536262|Primary|Number (%) of Patients With Drug-related AEs|Number (%) of patients with drug-related Adverse Events (AEs).|From first drug administration until 21 days after the last administration, upto 392 days|Treated set: This patient set included all patients who received at least 1 dose of treatment.||percentage of participants|||Number
682854|NCT01536184|Secondary|The Strengths and Difficulties Questionnaire SDQ|The Emotional Symptoms (SDQ-ES), Conduct Problems (SDQ-CP), Hyperactivity (SDQ-HA), Peer Problems (SDQ-PP), and Prosocial (SDQ-PS) Scales each range from 0-10 Higher values in (ES, CP, HA, and PP) indicate a greater degree of abnormal behavior; low values indicate more normative behavior. For the PS scale, higher values indicate greater strengths in prosocial behaviour and lower values indicate more difficulties with prosocial behavior. A Total Difficulties Score ranges from 0 to 40 with higher scores reflecting higher levels of behavioral difficulty. The Total Impact Supplement Score (Total IS) ranges from 0 to 10 with higher values indicating greater behavioral difficulty and social impairment.|Administered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup)|Please see category specific n values below.||units on a scale||Full Range|Mean
682855|NCT01536184|Secondary|The Depression Anxiety Stress Scale (DASS)|"A self-report measure of depression, anxiety, and stress. The scales of the DASS show high internal consistency and produce meaningful discriminations in different settings, and are appropriate for measuring the emotional states of caregivers over time.
The score for each item ranges from 0 to 3, where 0 indicates did not apply to me at all and 3 indicates applied to me very much, or most of the time. The individual items are combined using a scoring template into measures of Depression (D), Anxiety (A), and Stress (S). Depression is scored out of 28 where 0-9 is normal and 10-28 reflect mild, moderate, and severe degrees of depression. Anxiety is scored out of 20 where 0-7 is normal and 8-20 reflect mild, moderate, and severe degrees of anxiety. Stress is scored out of 34 where 0-14 is normal and 15-34 reflect mild, moderate, and severe degrees of stress."|Administered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup)|Receives COS Intervention Pretest= 8; Post-test=6; Follow-up=5 Control Group Pretest=4; Post-test=2; Follow-up=2||units on a scale||Full Range|Mean
682856|NCT01536184|Secondary|The Parenting Stress Index (PSI)|"A parent-report questionnaire of parental stress reflecting parent-child interaction style and difficult child behaviour. There are two main domain scores, a Child Domain Score and Parent Domain Score from which a Total Stress Score is calculated.
Child and Parent Domain raw scores combine to form a Total Stress raw score. Higher scores for each item indicate a higher degree of negative attributes in the given scale while lower scores indicate lower relationship stress and a greater sense of enjoyment in the relationship.
Items include:
Defensive Responding (DR) Score range 7-35 Parental Distress (PD) Score range 12-60 Parent-Child Dysfunctional Interaction (PCDI) Score range 12-60 Difficult Child (DC) Score range 12-60 PSI Total Stress Score range 36-180"|Administered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup)|||units on a scale||Full Range|Mean
682857|NCT01536184|Secondary|The Parenting Scale (TPS)|"A self-report measure of dysfunctional parenting practices including laxness, over-reactivity, and verbosity. The scale has good internal consistency and test-restest reliability and scores are consistent with other measures of dysfunctional discipline and child misbehaviour.
Each subscale score, ranges from 1 to 7; for each subscale (Laxness, Overreactivity, Verbosity) lower values indicate a lower degree of self-perceived ineffective parenting behaviors and higher values indicate a greater degree of self perceived ineffective parenting behaviours. The total score is calculated from a combination of each subscale and also ranges from 1 to 7, reflecting the degree of ineffective parenting behaviours across all categories with lower values indicate a lower degree of self-perceived ineffective parenting behaviors and higher values indicate a greater degree of self perceived ineffective parenting behaviours."|Administered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup)|Number of Participants Analyzed Receives COS Intervention Pretest= 8; Post-test=6; Follow-up=5 Control Group Pretest=4; Post-test=2; Follow-up=2||units on a scale||Full Range|Mean
682858|NCT01536184|Primary|Attachment Classification|Attachment classified using Ainsworth's Strange Situation protocol: Secure, Anxious-Insecure, Anxious-Avoidant, Avoidant, Disorganized.|Administered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup)|Number of participants analyzed Receives COS Intervention Pretest= 8; Post-test=3; Follow-up=4 Control Group Pretest=4; Post-test=1; Follow-up=1||participants|||Number
682859|NCT01536171|Primary|Metabolic Rate During Barefoot and Shod Running|"This study will measure the metabolic rate when a person runs on the treadmill with shoes (shod) and without shoes.
Each person will run for 20 minutes on the treadmill on two different days, one with and one day without shoes."|Study consists of two visits, approximately 2 hours for each visit|||kilojoules per minute||Standard Deviation|Mean
682860|NCT01536171|Secondary|Peak Impact Forces During Barefoot and Shod Running|"This study will be measuring the peak impact forces that a runner produces when running on the treadmill with shoes (shod) and without shoes.
Each person will run for 20 minutes on the treadmill on two different days, one with and one day without shoes."|Study consists of two visits, approximately 2 hours for each visit|||Newtons||Standard Deviation|Mean
682861|NCT01536145|Secondary|Time to Disease Progression|Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever came first. Tumor progression was determined from oncologic assessment data (where data met the criteria for progressive disease [PD])|Baseline up to end of treatment|A substantial number of participants were not followed-up prior to disease progression, therefore time to disease progression was not estimated.|||||
682862|NCT01536145|Secondary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR based on assessment of confirmed complete remission (CR) or confirmed partial remission (PR) according to Southwest Oncology Group (SWOG) criteria. CR were those with absence of bone marrow or blood findings of multiple myeloma. PR were those with a 50-74% reduction in the quantitative immunoglobulin, and if present, a 50-89% reduction in the urine M-component (Bence-Jones protein).|Baseline, Day 1 at predose/cycle, end of study (30-60 days post last dose)|All participants who completed a minimum of 1 cycle of treatment were evaluable for response. Participants who developed early progressive disease (regardless of the duration of study treatment) prior to response evaluation were also evaluable for response.||percentage of participants|||Number
682907|NCT01536067|Secondary|Frequency of Very Good Partial Response (VGPR)||Every 28 days|Due to the study's early termination and low accrual, data were not collected for this assessment.|||||
682863|NCT01536145|Secondary|Human Anti-human Antibody (HAHA) Response to CP-751,871||30 minutes predose in Cycle 1 and subsequent cycles, end of study visit (Days 30 and 60) for dose levels below 0.8 mg/kg; 30 minutes predose in Cycle 1 and last scheduled follow-up visit for dose levels greater than or equal to 0.8 mg/kg|All treated participants with HAHA samples collected at time points when circulating CP-751,871 concentrations were below the lower limit of quantification.|||||Number
682864|NCT01536145|Secondary|Pharmacodynamic-based Dose|The dose associated with PK exposure that was associated with 80% of the maximal effect based on down-regulation of insulin-like growth factor 1 receptor (IGF-1R) expression|Cycle 1 (Week 4 or Week 8)|Data from analysis of the PK/pharmacodynamic relationship could not permit a reliable estimate of the pharmacodynamic-based dose.|||||
682865|NCT01536145|Secondary|Multiple Dose Minimum Observed Plasma Trough Concentration (Cmin) for CP-751,871||0 hour (predose) in Cycles 2 up to 16|Multiple dose Cmin data were listed for individual subjects, however were not summarized by descriptive statistics.|||||
682866|NCT01536145|Secondary|Multiple Dose Cinf for CP-751,871||1 hour postdose in Cycles 2 up to 16|Multiple dose Cinf data were listed for individual subjects, however were not summarized by descriptive statistics.|||||
682867|NCT01536145|Secondary|Single Dose Systemic Clearance (CL) for CP-751,871||Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504 and 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose|All participants treated who had at least 1 of the PK parameters of primary interest.||milliliter/day/kilogram (mL/day/kg)||Standard Deviation|Mean
682868|NCT01536145|Secondary|Single Dose Volume of Distribution at Steady State (Vss) for CP-751,871||Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504 and 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose|All participants treated who had at least 1 of the PK parameters of primary interest.||mL/kg||Standard Deviation|Mean
682869|NCT01536145|Secondary|Single Dose Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] for CP-751,871||Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504 and 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose|All participants treated who had at least 1 of the PK parameters of primary interest.||mg•hr/L||Standard Deviation|Mean
682870|NCT01536145|Secondary|Single Dose Plasma Decay Half-life (t1/2) for CP-751,871||Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504 and 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose|All participants treated who had at least 1 of the PK parameters of primary interest.||days||Standard Deviation|Mean
682871|NCT01536145|Secondary|Single Dose Volume of Distribution (Vz) for CP-751,871||Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504 and 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose|All participants treated who had at least 1 of the PK parameters of primary interest.||milliliter/kilogram (mL/kg )||Standard Deviation|Mean
682872|NCT01536145|Secondary|Single Dose Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for CP-751,871||Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504, 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose|All participants treated who had at least 1 of the pharmacokinetic (PK) parameters of primary interest.||milligram•hour/liter (mg•hr/L)||Standard Deviation|Mean
682873|NCT01536145|Secondary|Single Dose End-of-infusion Concentration (Cinf) for CP-751,871||1 hour postdose in Cycle 1|All participants treated who had at least 1 concentration.||milligram/liter (mg/L)||Standard Deviation|Mean
682874|NCT01536145|Primary|Maximum Tolerated Dose (MTD)|The highest dose level at which not more than 1 dose-limiting toxicity (DLT) was observed during Cycle 1 in 6 participants|Baseline up to Cycle 1 (Week 4 or Week 8)|All participants who received at least 1 dose of study drug CP-751,871.||mg/kg|||Number
682875|NCT01536119|Secondary|Paternal Infant Feeding Attitude|Paternal infant feeding attitude will be assessed using the Iowa Infant Feeding Attitude Scale. This scale consist of 17 items with a five point response range (1-5). The total scores range from 17-85. Negative items were reverse scored. Lower scores indicate a preference for formula feeding, while higher scores indicating a preference for breastfeeding.|6 weeks postpartum|Analysis population included only fathers who completed the scale at 6 weeks postpartum||units on a scale||Standard Deviation|Mean
682876|NCT01536119|Secondary|Paternal Breastfeeding Self-Efficacy|"Breastfeeding Self-Efficacy Scale- Short Form will be adapted and used to assess fathers' confidence with assisting their partner with breastfeeding.
This instrument has 14 items, with responses ranging from 1-5. The total scores range from 14-70 with higher scores indicating higher breastfeeding self-efficacy."|6 weeks postpartum|Analysis population included fathers completed the scale and who had infants breastfeeding at 6 weeks postpartum (fathers of infants fed expressed breastmilk were not included).||units on a scale||Standard Deviation|Mean
682877|NCT01536119|Secondary|Breastfeeding Support|Breastfeeding support is defined as the appraisal, emotional, informational and instrumental support the mother receives from her partner. This component of coparenting will be measured using the Postpartum Partner Support Scale (PPSS), which is a 24-item self-report instrument. The items are rated on a 4 point scale to produce a summative score ranging from 25-100. Two negative items are reversed scored and the higher scores indicate higher levels of postpartum-specific partner support.|12 weeks|Analysis population included only mothers who completed the scale at 12 weeks postpartum||units on a scale||Standard Deviation|Mean
682878|NCT01536119|Secondary|Breastfeeding Support|Breastfeeding support is defined as the appraisal, emotional, informational and instrumental support the mother receives from her partner. This component of coparenting will be measured using the Postpartum Partner Support Scale (PPSS), which is a 24-item self-report instrument. The items are rated on a 4 point scale to produce a summative score ranging from 25-100. Two negative items are reversed scored and the higher scores indicate higher levels of postpartum-specific partner support.|6 weeks|Analysis population included only mothers who completed the scale at 6 weeks postpartum.||units on a scale||Standard Deviation|Mean
682879|NCT01536119|Secondary|Coparenting Relationship|Coparenting is the degree to which parents work together to achieve parenting goals. This will be measured using Feinberg, Brown and Kan (2010) Coparenting Relationship Scale (CRS). There are 35 items in total in this tool. There is a 7 point response scale ranging from 0 to 6. Total scores range from 0 - 210. Negative items are reversed. Higher scores indicated positive coparenting.|12 weeks postpartum|Analysis population included only mothers who completed the scale at 12 weeks postpartum.||units on a scale||Standard Deviation|Mean
682908|NCT01536067|Secondary|Frequency of Near (n)CR||Every 28 days|Due to the study's early termination and low accrual, data were not collected for this assessment.|||||
682880|NCT01536119|Secondary|Coparenting Relationship|Coparenting is the degree to which parents work together to achieve parenting goals. This will be measured using Feinberg, Brown and Kan (2010) Coparenting Relationship Scale (CRS) Brief Form. There are 14 items in total in this tool. There is a 7 point response scale ranging from 0 - 6. The total score ranges from 0 - 84. Negative items are reversed and the higher scores indicate positive coparenting.|6 weeks|Analysis population included only mothers who completed the questionnaire at 6 weeks postpartum.||units on a scale||Standard Deviation|Mean
682881|NCT01536119|Secondary|Any Breastfeeding|Any breastfeeding was measured by asking the mother what she had fed her infant in the last 24 hours and what she usually feeds her baby. Any breastfeeding indicated the mother was breastfeeding or providing her infant with expressed breastmilk and this included combined feeding with formula. If the mother responded she was only formula feeding this indicated the infant she was not doing any breastfeeding or being fed any breast milk.|12 weeks|Analysis population included only mothers||participants|||Number
682882|NCT01536119|Secondary|Any Breastfeeding|Any breastfeeding was measured by asking the mother what she had fed her infant in the last 24 hours and what she usually feeds her baby. Any breastfeeding indicated the mother was breastfeeding or providing her infant with expressed breastmilk and this included combined feeding with formula. If the mother responded she was only formula feeding this indicated the infant she was not doing any breastfeeding or being fed any breast milk.|6 weeks|Analysis population included only mothers||participants|||Number
682883|NCT01536119|Secondary|Exclusive Breastfeeding|Exclusive breastfeeding will be determined by asking the mother what she has fed her baby in the last 24 hrs and what she usually feeds her baby. This is consistent with the World Health Organizations definition of exclusive breastfeeding and full breastfeeding described by Labbok and Krasovec (1990). This is defined as no food or liquid other than breast milk given to the infant; however, undiluted drops or syrups consisting of vitamins, minerals supplements or medicines are included (Breastfeeding Committee for Canada, 2006; WHO, 2010).|6 weeks|Analysis population included only mothers||percentage of participants|||Number
682884|NCT01536119|Primary|Exclusive Breastfeeding Rate at 12 Weeks Postpartum|Exclusive breastfeeding will be determined by asking the mother what she has fed her baby in the last 24 hrs and what she usually feeds her baby. This is consistent with the World Health Organizations definition of exclusive breastfeeding and full breastfeeding described by Labbok and Krasovec (1990). This is defined as no food or liquid other than breast milk given to the infant; however, undiluted drops or syrups consisting of vitamins, minerals supplements or medicines are included (Breastfeeding Committee for Canada, 2006; WHO, 2010).|12 weeks postpartum|Analysis population included only mothers||percentage of participants|||Number
682885|NCT01536093|Secondary|Development of Adverse Effects|"category of adverse effects
general - fever or hypothermia, rash
respiratory & cardiovascular - apnea, tachypnea, desaturation, hypotension, bradycardia, tachycardia
gastrointestinal - abdominal distension, bilious gastric remain, vomiting, bloody stool, necrotizing enterocolitis
renal - oliguria (urine output < 1.0cc/kg/day)
laboratory - hypo-/hyper-natremia, acidosis, hypercarbia"|from the start date of oropharyngeal administration of colostrum or sterile water to 1 week of age||||||
682886|NCT01536093|Secondary|In-hospital Death||up to 4 months of age||||||
682887|NCT01536093|Secondary|Development of Intraventricular Hemorrhage ≥ Grade 3||up to 4 months of age||||||
682888|NCT01536093|Secondary|Development of Bronchopulmonary Dysplasia ≥ Moderate||up to 4 months of age||||||
682889|NCT01536093|Secondary|Episodes of Pneumonia|numbers of documented pneumonia events those accompanied with increased tracheal secretion, increased ventilatory setting and treated with antibiotics|from date of randomization up to 4 months of age||||||
682890|NCT01536093|Secondary|Episodes of Necrotizing Enterocolitis ≥ Bell's Stage 2||from date of randomization up to 4 months of age||||||
682891|NCT01536093|Secondary|Episodes of Culture Positive Sepsis|numbers of documented sepsis events defined as isolation of the microorganism from ≥ 1 blood culture + ≥ 1 clinical symptoms or sign (fever, hypothermia, apnea, bradycardia, hypo-/hyperglycemia)|from date of randomization up to 4 months of age||||||
682892|NCT01536093|Secondary|Total Hospital Admission Duration|days from admission to discharge from NICU|up to 4 months of age||||||
682893|NCT01536093|Secondary|Time to Reach Full Feeding|day of life when the baby reaches full enteral feeding, defined as a volume above 120~130mL/kg/day|up to 2 months of age||||||
682894|NCT01536093|Secondary|Concentration of Salivary Lactoferrin, Lysozyme, Alpha-lactalbumin and Cytokines||2 weeks of age||||||
682895|NCT01536093|Secondary|Concentration of Salivary Lactoferrin, Lysozyme, Alpha-lactalbumin and Cytokines||1 week of age||||||
682896|NCT01536093|Secondary|Concentration of Urinary IL-1 Beta||2 weeks of age|||ug per g creatinine||Standard Deviation|Mean
682897|NCT01536093|Secondary|Concentration of Urinary Lactoferrin||1 week of age|||ug per g creatinine||Standard Deviation|Mean
682898|NCT01536093|Secondary|Salivary IL-8 Concentration at 2 Weeks of Age||2 weeks of age|||ng/mL||Standard Deviation|Mean
682899|NCT01536093|Secondary|Salivary TGF-beta 1 Concentration at 2 Week of Age||2 week of age|||ug/mL||Standard Deviation|Mean
682900|NCT01536093|Secondary|Urinary Secretary IgA Concentration at 1 Week of Age||1 week of age|||ng per g creatinine||Standard Deviation|Mean
682901|NCT01536093|Primary|Urinary Secretary IgA Concentration at 2 Weeks of Age||2 weeks of age|||ng per g creatinine||Standard Deviation|Mean
682902|NCT01536067|Secondary|Frequency and Severity of Toxicity as Graded According to the Cancer Therapeutic Evaluation Program (CTEP) Common Toxicity Criteria (CTC) Version 4.0|Maximum grade per participant of any AE.|Every 30 days for 2 months|All treated and eligible patients||participants|||Number
682903|NCT01536067|Secondary|Duration of Response||From the observation of a response to the time of disease progression, assessed up to 12 months|Due to the study's early termination and low accrual, data were not collected for this assessment.|||||
682904|NCT01536067|Secondary|Progression-free Survival||From start of treatment to disease progression or death (regardless of the cause of death), whichever comes first, assessed up to 12 months|Due to the study's early termination and low accrual, data were not collected for this assessment.|||||
682905|NCT01536067|Secondary|Time to Progression||From start of treatment to disease progression, assessed up to 12 months|Due to the study's early termination and low accrual, data were not collected for this assessment.|||||
682906|NCT01536067|Secondary|Frequency of PR||Every 28 days|Due to the study's early termination and low accrual, data were not collected for this assessment.|||||
682911|NCT01536015|Secondary|Change in Score on Parkinson’s Disease Questionnaire (PDQ8) From Baseline to the End of 7-week Maintenance Period|The Parkinson’s Disease Questionnaire (PDQ-8) is a self-administered 8-item questionnaire that assesses issues associated with Parkinson's disease. Each single item of the 8-item questionnaire ranges from 0 (never) to 4 (always).|Baseline to 10 weeks|This study was terminated early because of low enrollment. Due to the early termination no analysis tables of efficacy data were done and no descriptive summaries of efficacy data were produced.|||||
682912|NCT01536015|Secondary|Change in Score on Fatigue Severity Scale (FSS) From Baseline to the End of 7-week Maintenance Period|"The Fatigue Severity Scale is a 9-item scale measuring the impact of fatigue on everyday functioning (e.g. fatigue interferes with my work, each single item of the scale ranging from 1 (disagree) to 7 (agree)."|Baseline to 10 weeks|This study was terminated early because of low enrollment. Due to the early termination no analysis tables of efficacy data were done and no descriptive summaries of efficacy data were produced.|||||
682913|NCT01536015|Secondary|Change in Score on Gastrointestinal Neurodegenerative Scale (GIND) From Baseline to the End of the of the 7-week Maintenance Period|Gastrointestinal Neurodegenerative Scale (GIND) is an 18-item scale measuring gastrointestinal dysfunction with each single item of the scale ranging from 0 (never or not at all) to 5 (very severe).|Baseline to 10 weeks|This study was terminated early because of low enrollment. Due to the early termination no analysis tables of efficacy data were done and no descriptive summaries of efficacy data were produced.|||||
682914|NCT01536015|Secondary|"Change in Predictability of Off Time (Using MDS UPDRS Part IV Item 4.5) From Baseline to End of the 7-week Maintenance Period"|The Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS UPDRS) Part IV is a 6-item scale with each single item of the scale ranging from 0 (normal) to 4 (severe).|Baseline to 10 weeks|This study was terminated early because of low enrollment. Due to the early termination no analysis tables of efficacy data were done and no descriptive summaries of efficacy data were produced.|||||
682915|NCT01536015|Secondary|"Change in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS UPDRS) Part III (Motor Examination) in the on State From Baseline to the End of the 7-week Maintenance Period"|The Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS UPDRS) Part III is an 18-item scale with each single item of the scale ranging from 0 (normal) to 4 (severe).|Baseline to 10 weeks|This study was terminated early because of low enrollment. Due to the early termination no analysis tables of efficacy data were done and no descriptive summaries of efficacy data were produced.|||||
682916|NCT01536015|Primary|"Change in Rotigotine Versus Placebo in the Absolute Time Spent Off From Baseline to the End of the 7-week Maintenance Period"|"Mean number of hours marked off during a 24-hour period."|Baseline to 10 weeks|This study was terminated early because of low enrollment. Due to the early termination no analysis tables of efficacy data were done and no descriptive summaries of efficacy data were produced.|||||
682917|NCT01535976|Primary|Intraoperative Hypoventilation|Subjects receiving intraoperative ketamine in addition to propofol will demonstrate less hypoventilation during the surgical procedure.|8 hours|The median percentage of the sedation time with TCO2 > 50 mmHg||% time||95% Confidence Interval|Median
682918|NCT01535807|Secondary|Post Operative Atrial Fibrillation|Post operative rhythm during hospital stay. Rhythm on discharge. Rhythm at cardiac surgery visit. Rhythm within 30 days of surgery.|Within 30 days||||||
682919|NCT01535807|Primary|Inflammatory Biomarkers|"The identification of global low molecular weight (LMW) serum proteomic changes associated with CorMatrix ECM treated patients.
Identification of porcine specific LMW and phosphoproteomic serum protein changes associated with CorMatrix ECM treated patients."|Blood and Pericardial Fluid Baseline draw. Pericardial Fluid Post-Op Draw. Blood Post-Op draw Day 1 and Day 3.|||participants|||Number
682920|NCT01535729|Secondary|Median Overall Survival: Best Response to Prior Chemotherapy|Overall Survival was defined as the time from the date of first medication to the date of death from any cause. If death was not observed during the study, survival time was censored at the last day of observation (latest at the end of study after one year). Overall Survival was analyzed by means of Kaplan-Meier Methods.|From Baseline then every 3 months from Month 3 until death (Maximum follow-up to Month 40)|Data for best response to prior chemotherapy could not be collected, as it was not recorded in the CRF, hence, the analysis could not be performed.|||||
682921|NCT01535729|Secondary|Median Overall Survival: Smoking Status|Overall Survival was defined as the time from the date of first medication to the date of death from any cause. If death was not observed during the study, survival time was censored at the last day of observation (latest at the end of study after one year). Overall Survival was analyzed by means of Kaplan-Meier Methods. Median survival based on the factor of smoking status (smoker, non-smoker and ex-smoker) were reported.|From Baseline then every 3 months from Month 3 until death (Maximum follow-up to Month 40)|SAF||months||95% Confidence Interval|Median
682922|NCT01535729|Secondary|Median Overall Survival: Gender|Overall Survival was defined as the time from the date of first medication to the date of death from any cause. If death was not observed during the study, survival time was censored at the last day of observation (latest at the end of study after one year). Overall Survival was analyzed by means of Kaplan-Meier Methods. Median survival based on the factor of gender (male and female) were reported.|From Baseline then every 3 months from Month 3 until death (Maximum follow-up to Month 40)|SAF||months||95% Confidence Interval|Median
682923|NCT01535729|Secondary|Median Overall Survival: Overall|Overall Survival was defined as the time from the date of first medication to the date of death from any cause. If death was not observed during the study, survival time was censored at the last day of observation (latest at the end of study after one year). Overall Survival was analyzed by means of Kaplan-Meier Methods.|From Baseline then every 3 months from Month 3 until death (Maximum follow-up to Month 40)|SAF||months||95% Confidence Interval|Median
682936|NCT01535729|Secondary|Percentage of Participants With Fatigue Based on Severity During the Course of Time|Severity was categorized as Grades 1, 2, 3, 4 and 5. Grade 1= mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2= moderate; minimal, local or non-invasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL). Grade 3= severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4= life-threatening consequences; urgent intervention indicated. Grade 5= death related to adverse event. Only participants that were included in any of the specified categories were reported.|Months 3, 6, 9, 12|SAF||percentage of participants|||Number
682924|NCT01535729|Secondary|Median Progression Free Survival: Best Response to Prior Chemotherapy|Progression-free survival time was defined as the time from the date of first medication to the date of disease progression or death from any cause. If neither progression nor death was observed during the study, PFS time was censored at the last day of observation. PD was at least a 20% increase in the sum of diameters of TLs, taking as a reference the smallest sum on study (this included the BL sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm.|From Baseline then every 3 months from Month 3 until disease progression (Maximum follow-up to Month 40)|Data for best response to prior chemotherapy could not be collected, as it was not recorded in the Case Report Form (CRF), hence, the analysis could not be performed.|||||
682925|NCT01535729|Secondary|Median Progression Free Survival: Smoking Status|Progression-free survival time was defined as the time from the date of first medication to the date of disease progression or death from any cause. If neither progression nor death was observed during the study, PFS time was censored at the last day of observation. PD was at least a 20% increase in the sum of diameters of TLs, taking as a reference the smallest sum on study (this included the BL sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. Median progression-free survival based on the factor of smoking status (smoker, non-smoker and ex-smoker) were reported.|From Baseline then every 3 months from Month 3 until disease progression (Maximum follow-up to Month 40)|SAF||months||95% Confidence Interval|Median
682926|NCT01535729|Secondary|Median Progression Free Survival: Gender|Progression-free survival time was defined as the time from the date of first medication to the date of disease progression or death from any cause. If neither progression nor death was observed during the study, PFS time was censored at the last day of observation. PD was at least a 20% increase in the sum of diameters of TLs, taking as a reference the smallest sum on study (this included the BL sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. Median progression-free survival based on the factor of gender (male and female) were reported.|From Baseline then every 3 months from Month 3 until disease progression (Maximum follow-up to Month 40)|SAF||months||95% Confidence Interval|Median
682927|NCT01535729|Secondary|Median Progression Free Survival: Age|Progression-free survival time was defined as the time from the date of first medication to the date of disease progression or death from any cause. If neither progression nor death was observed during the study, PFS time was censored at the last day of observation. PD was at least a 20% increase in the sum of diameters of TLs, taking as a reference the smallest sum on study (this included the BL sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. Median progression-free survival based on the factor of age (65-69, 70-74, 75-79, ≥80 years) were reported.|From Baseline then every 3 months from Month 3 until disease progression (Maximum follow-up to Month 40)|SAF||months||95% Confidence Interval|Median
682928|NCT01535729|Secondary|Median Progression Free Survival: Overall|Progression-free survival time was defined as the time from the date of first medication to the date of disease progression or death from any cause. If neither progression no death was observed during the study, PFS time was censored at the last day of observation. PD was at least a 20% increase in the sum of diameters of TLs, taking as a reference the smallest sum on study (this included the BL sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm.|From Baseline then every 3 months from Month 3 until disease progression (Maximum follow-up to Month 40)|SAF||months||95% Confidence Interval|Median
682929|NCT01535729|Secondary|Percentage of Participants With Remission of CR and PR|Remission was defined as participants with CR or PR. CR: disappearance of all TLs and non-TLs, with any pathological lymph nodes (whether target or non-target) having a reduction in short axis to less than 10 mm. PR: at least a 30% decrease in the sum of diameters of TLs, taking as reference the BL sum diameters.|Months 3, 6, 9, 12|SAF||percentage of participants|||Number
682930|NCT01535729|Secondary|Time to Start of Erlotinib Therapy After End of First Line Therapy||Baseline|SAF with number of participants evaluable for this outcome measure.||months||Full Range|Median
682931|NCT01535729|Secondary|Percentage of Participants With Complete Response (CR), Partial Response (PR) and Stable Disease (SD)|Response rate was observed during the treatment period according to Response Evaluation Criteria in Solid Tumors (RECIST). It consisted of CR, PR, SD and progressive disease (PD). Participants with CR, PR and SD were reported. CR: disappearance of all target lesions (TLs) and non-TLs, with any pathological lymph nodes (whether target or non-target) having a reduction in short axis to less than 10 millimeters (mm). PR: at least a 30 percent (%) decrease in the sum of diameters of TLs, taking as reference the baseline (BL) sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least 20% increase in the sum of diameters of TLs, taking as a reference the smallest sum on study (this included the BL sum if that was the smallest on study). In addition to the relative increase of 20%, the sum also demonstrated an absolute increase of at least 5 mm.|Months 3, 6, 9, 12|SAF||percentage of participants|||Number
682932|NCT01535729|Secondary|Percentage of Participants With Dyspnea by Severity|Severity of dyspnea was categorized as mild, moderate, severe, life-threatening and unknown. Only participants that were included in any of the specified categories in the course of time were reported. Participants with no dyspnea were not included.|Baseline, Months 3, 6, 9, 12|SAF||percentage of participants|||Number
682933|NCT01535729|Secondary|Percentage of Participants With Cough by Severity|Severity of cough was categorized as mild, moderate, severe and unknown. Only participants that were included in any of the specified categories in the course of time were reported. Participants with no cough were not included.|Baseline, Months 3, 6, 9, 12|SAF||percentage of participants|||Number
682934|NCT01535729|Secondary|Percentage of Participants With Dose Withdrawals by Reason|Reasons for dose withdrawals included progression, participants' wish, intolerance, others and not known. Only participants that were included in any of the specified categories were reported.|Months 3, 6, 9, 12|SAF||percentage of participants|||Number
682935|NCT01535729|Secondary|Percentage of Participants With Dose Modifications by Reason|Dose modification included increase or decreased in the dose of the drug and interrupted dose. Reasons for dose modification included progression, participants' wish, intolerance and others. Only participants that were included in any of the specified categories were reported.|Months 3, 6, 9, 12|SAF||percentage of participants|||Number
682937|NCT01535729|Secondary|Percentage of Participants With Diarrhea Based on Severity During the Course of Time|Severity was categorized as Grades 1, 2, 3, 4 and 5. Grade 1= mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2= moderate; minimal, local or non-invasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL). Grade 3= severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4= life-threatening consequences; urgent intervention indicated. Grade 5= death related to adverse event. Only participants that were included in any of the specified categories were reported.|Months 3, 6, 9, 12|SAF||percentage of participants|||Number
682938|NCT01535729|Secondary|Percentage of Participants With Rash Based on Severity During the Course of Time|Severity was categorized as Grades 1, 2, 3, 4 and 5. Grade 1= mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2= moderate; minimal, local or non-invasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL). Grade 3= severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4= life-threatening consequences; urgent intervention indicated. Grade 5= death related to adverse event. Only participants that were included in any of the specified categories were reported.|Months 3, 6, 9, 12|SAF||percentage of participants|||Number
682939|NCT01535729|Secondary|Percentage of Participants With Diarrhea||Months 3, 6, 9, 12|SAF||percentage of participants|||Number
682940|NCT01535729|Secondary|Percentage of Participants With Rash||Months 3, 6, 9, 12|SAF||percentage of participants|||Number
682941|NCT01535729|Secondary|Percentage of Participants With Fatigue||Months 3, 6, 9, 12|SAF||percentage of participants|||Number
682942|NCT01535729|Secondary|Median Overall Survival: Age|Overall Survival was defined as the time from the date of first medication to the date of death from any cause. If death was not observed during the study, survival time was censored at the last day of observation (latest at the end of study after one year). Overall Survival was analyzed by means of Kaplan-Meier Methods. Median survival based on the factor of age (65-69, 70-74, 75-79, ≥80 years) were reported.|From Baseline then every 3 months from Month 3 until death (Maximum follow-up to Month 40)|SAF||months||95% Confidence Interval|Median
682943|NCT01535729|Primary|Percentage of Participants Who Were Alive 1 Year After Start of Treatment|Overall survival was defined as the time from the date of first medication to the date of death from any cause. If death was not observed during the study, survival time was censored at the last day of observation (latest at the end of study after one year). Overall percentage of participants who were alive 1 year after study treatment and those based on the factor of age (65-69, 70-74, 75-79, ≥ 80 years) were reported.|Year 1|SAF||percentage of participants||95% Confidence Interval|Number
682944|NCT01535664|Primary|Composite Score Overall Balance After Withdrawal and Reinitiation of Dalfampridine-ER 10mg|"The co-primary efficacy variable was overall balance. This novel composite score was created from standardized individual NeuroCom test results (Z-scores).
Overall balance is a weighted average of Sensory Organization Test (SOT) fixed surface eyes open, fixed surface eyes closed, walls moving eyes open, surface moving eyes open, surface moving eyes closed, surface and walls moving eyes open; Limits of Stability Test (LOS) measuring reaction time, movement velocity, endpoint excursion, maximum excursion and directional control; and Adaptation Test (ADT) measuring the averaged, raw sway and center of force during rotational disturbances. ZBAL (Z-Score Balance)= (ZSOT*0.5) + (ZADT*0.2) + (ZLOS*0.3)
Overall balance was calculated by transforming ZBAL into a percentile using the standard normal distribution. This rescales the Z-score to a scale from 0 to 100. A higher score is indicative of better performance."|11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11)|Full Analysis Population (FAP)||units on a scale||Standard Deviation|Mean
682945|NCT01535664|Secondary|Change on the Timed 25 Foot Walk Test (T25FW) After Withdrawal and Reinitiation of Dalfampridine-ER 10mg|"The T25FW test is a measure of ambulatory function that provides quantitative data and is used widely in the MS population
A higher walking speed is indicative of better performance"|11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11)|Full Analysis Population||Feet per second (ft/s)||Standard Deviation|Mean
682946|NCT01535664|Secondary|Change on the Two Minute Walk Test (2MWT) After Withdrawal and Reinitiation of Dalfampridine-ER 10mg|"Subjects will walk without assistance for 2 minutes and the distance will be measured and timed by the use of a stop watch.
A larger walking distance is indicative of better performance."|11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11)|Full Analysis Population||Meters||Standard Deviation|Mean
682947|NCT01535664|Secondary|Change on the Berg's Balance Scale (BBS) After Withdrawal and Reinitiation of Dalfampridine-ER 10mg|The BBS is a 14-item scale that evaluates subjects ability to sit, stand, reach, maintain single-leg stance, and turn. The scoring is rated from 0 (cannot perform task) to 4 (normal performance of task) for each of 14 items. The maximum possible score is 56 and the lowest 0. A higher total score is indicative of better performance.|11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11)|Full Analysis Population||units on a scale||Standard Deviation|Mean
682948|NCT01535664|Primary|Composite Score Overall Gait After Withdrawal and Reinitiation of Dalfampridine-ER 10mg|"The co-primary efficacy variable was overall gait. This novel composite score was created from standardized individual NeuroCom test results (Z-scores).
ZGAIT (Z-Score Gait) is the average of Walk Across (WA) measuring step width, step length, speed; Tandem Walk (TW) measuring step width, speed and end sway, and Step/Quick turn (SQT) measuring turn time and turn sway).
Overall gait was calculated by transforming ZGAIT into a percentile using the standard normal distribution. This rescales the Z-score to a scale from 0 to 100. A higher score is indicative of better performance."|11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11)|Full Analysis Population (FAP)||units on a scale||Standard Deviation|Mean
682949|NCT01535638|Primary|Cmax|Maximum measured concentration of Deleobuvir in plasma. The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.|1:00 h before drug administration and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 48:00 h after drug administration|The pharmacokinetic set (PKS).||nmol/L||Geometric Coefficient of Variation|Geometric Mean
682950|NCT01535638|Primary|AUC0-∞|"Area under the concentration-time curve of Deleobuvir in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).
The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1:00 (h) hour before drug administration and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 48:00 h after drug administration|The pharmacokinetic set (PKS) included all subjects in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK and no vomiting must have occurred at or before two times the median tmax.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
682951|NCT01535599|Secondary|Median Time to Cessation of Ear Pain as Reported by the Patient or Parent/Legal Guardian Via the Telephone Diary|Cessation of ear pain was defined as occurring on the first time point that ear pain was absent (morning or evening) and did not return in any subsequent diary entries. Day 1 was the starting point for this time-to-event analysis. For this analysis, all patients who did not complete the study and ear pain never ceased had their ear pain considered as being present throughout the planned duration of the study.|Time to event, up to Day 11|This analysis population includes the pathogen positive participants of the intent-to-treat (ITT) analysis set, ie, all participants who received study medication and were pathogen positive in the study ear at baseline. Patients who did not report ear pain at any diary entry during first 7 days of the study were excluded from the analysis.||days||Standard Error|Median
682952|NCT01535599|Secondary|Proportion of Patients With Microbiological Successes at the Day 11 (TOC) Visit|Microbiological success was considered attained if all pretherapy bacteria were absent from the exit otic specimen. The presence of fungi and/or yeast was not considered in the determination of microbiological success. In this analysis, the microbiological success value at Day 11 (TOC) was considered a failure for all pathogen positive patients who did not complete the study (for any reason). Proportion of patients is reported as a percentage.|Day 11|This analysis population includes the pathogen positive participants of the intent-to-treat (ITT) analysis set, ie, all participants who received study medication and were pathogen positive in the study ear at baseline.||percentage of participants|||Number
682953|NCT01535599|Primary|Proportion of Patients With Clinical Cures at the Day 11 (TOC) Visit|An otoscopic exam was conducted by the physician. Clinical cure was considered attained if the sum of the numerical scores of the 3 signs and symptoms of AOE (tenderness, erythema, and edema) was 0 at Day 11. In this analysis, the clinical cure outcome at Day 11 (TOC) was considered a failure for all pathogen positive patients who did not complete the study (for any reason). Proportion of patients is reported as a percentage.|Day 11|This analysis population includes the pathogen positive participants of the intent-to-treat (ITT) analysis set, ie, all participants who received study medication and were pathogen positive in the study ear at baseline.||percentage of participants|||Number
682954|NCT01535560|Secondary|Median Time (in Days) to Cessation of Ear Pain as Reported by the Patient or Parent/Legal Guadian Via the Telephone Diary|Cessation of ear pain was defined as occurring the first time point that ear pain was absent (morning or evening) and did not reoccur in any subsequent diary entries.|Time to event (Day 1 to Day 11)|This reporting group includes the pathogen positive patients of the intent-to-treat (ITT) analysis set, ie. all patients who received study drug and were pathogen positive in the study ear at baseline, minus missing responses.||Days||Standard Error|Median
682955|NCT01535560|Secondary|Proportion of Patients With Microbiological Successes at the Day 11 (TOC) Visit|Microbiological success was considered attained if all pre-therapy bacteria were absent from the exit otic specimen. The presence of fungi and/or yeast was not considered in the determination of microbiological success. Proportion of patients is reported as a percentage of participants.|Day 11|This reporting group includes the pathogen positive patients of the intent-to-treat (ITT) analysis set, ie. all patients who received study drug and were pathogen positive in the study ear at baseline.||Percentage of participants|||Number
682956|NCT01535560|Primary|Proportion of Patients With Clinical Cures at the Day 11 (TOC) Visit|An otoscopic exam was conducted by the physician. Clinical cure was considered attained if the sum of the numerical scores of the 3 signs and symptoms of AOE (tenderness, erythema, and edema) was 0 at Day 11. Proportion of patients is reported as percentage of participants.|Day 11|This reporting group includes the pathogen positive patients of the intent-to-treat (ITT) analysis set, ie. all patients who received study drug and were pathogen positive in the study ear at baseline.||Percentage of participants|||Number
682957|NCT01535365|Secondary|Request for Rescue Analgesia|Number of participants requesting a rescue analgesic be given|30 minutes|||Participants|||Number
682958|NCT01535365|Primary|Pain Score After Treatment|Pain measured with validated 100 mm VAS with 0 representing no pain and 100 representing most severe pain imaginable|30 minutes|this sample size gives 80% power to detect a size effect of one SD||mm||95% Confidence Interval|Mean
682959|NCT01535326|Other Pre-specified|Post-procedure Discomforts and 30 Day Complication Rate|telephone follow up for post-procedure discomforts and 30 day complication rate|one month||||||
682960|NCT01535326|Secondary|Number of Participants With at Least One Adenoma|the number of participants with at least one adenoma in each of the study groups.|9 to 12 months|||participants|||Number
682961|NCT01535326|Secondary|Patient Satisfaction Score|satisfaction score obtained after colonoscopy 0 = no satisfied; 10 = most satisfied|9 to 12 months|||units on a scale||Full Range|Median
682962|NCT01535326|Secondary|Patient Pain Score|The maximal pain score during insertion phase of colonoscopy was assessed with 0 to 10 scale VAS score (0: no pain; 10: maximal pain)|9 to 12 months|||units on a scale||Full Range|Median
682963|NCT01535326|Primary|Proportion of Patients Without Pain|proportion of patients without insertion pain during colonoscopy|up to 12 months|||participants|||Number
682973|NCT01535235|Primary|Change in HIV RNA (Copies/Million Rectal Cells)|Change in HIV RNA measured in GALT (gut-associated lymphoid tissue) from baseline|22 weeks|Three participants in the placebo group did not have sufficient cells for analysis for one of the time points.||copies/million rectal cells||Inter-Quartile Range|Median
682974|NCT01535222|Primary|Incidence of Serious Adverse Events|Number of patients experiencing Serious Adverse Events|7 days (day of surgery to day 7)|||participants|||Number
682975|NCT01535222|Primary|Incidence of Adverse Events|Number of patients experiencing Adverse Events|7 days (day of surgery to day 7)|||participants|||Number
682964|NCT01535261|Secondary|Mean Change in Patient-reported Outcomes in NEI-VFQ-25 Composite and Subscale Scores at Month 12 and Month 24 Compared to Baseline|The survey consists of 25 items representing 11 vision related constructs (general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision) plus a single-item general health rating question. The score of each individual question ranges from 0 (worst) to 100 which indicates the best possible response. The composite score and score of each of each construct also range from 0 to 100 as they are calculated as total scores divided by the number of questions. The higher the values of total scores represent better outcome. Scores per visit and of the change descriptively by visit.|Month 12 and Month 24|The Full analysis set (FAS) with use of Last Observation Carried Forward (LOCF) consisted of all patients who received at least 1 administration of study treatment and had at least 1 post-baseline assessment for BCVA in the study eye. The number of patients shown was with a value for both baseline and the post-baseline visit.||Score on a scale||Standard Deviation|Mean
682965|NCT01535261|Secondary|Mean Change in Central Reading Center (CRC)-Assessed Central Subfield Thickness (CSFT) From Month 12 and Month 24 Compared to Baseline|Retinal thickness was measured using Optical Coherence Tomography (OCT). The images were reviewed by a central reading center to ensure a standardized evaluation|Baseline, Month 12 and Month 24|The Full analysis set (FAS) with use of Last Observation Carried Forward (LOCF) consisted of all patients who received at least 1 administration of study treatment and had at least 1 post-baseline assessment for BCVA in the study eye. No data were excluded from the FAS analyses because of protocol deviations.||Microns||Standard Deviation|Mean
682966|NCT01535261|Secondary|Number of Patients With a BCVA Value of ≥ 73 Letters (Approximate 20/40 Snellen Chart Equivalent) at Month 12 and Month 24|Best Corrected Visual Acuity (BCVA) was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart at baseline and month 12 while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. BCVA above 73 letters at month 12 and month 24 indicates a positive outcome.|Month 12 and Month 24|The Full analysis set (FAS) with use of Last Observation Carried Forward (LOCF) consisted of all patients who received at least 1 administration of study treatment and had at least 1 post-baseline assessment for BCVA in the study eye. No data were excluded from the FAS analyses because of protocol deviations.||Letters|||Number
682967|NCT01535261|Secondary|Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 and Month 24 in the Study Eye|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An increased score indicates improvement in acuity. This outcome assessed the number of participants who had improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 letters of visual acuity at month 12 as compared with baseline|Month 12 and Month 24|The Full analysis set (FAS) with use of Last Observation Carried Forward (LOCF) consisted of all patients who received at least 1 administration of study treatment and had at least 1 post-baseline assessment for BCVA in the study eye. No data were excluded from the FAS analyses because of protocol deviations.||Letters|||Number
682968|NCT01535261|Secondary|Mean Average Change in BCVA From First Treatment Interruption (Due to BCVA Stabilization) to Month 12 and Month 24|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. Stability in visual acuity after treatment interruption indicates longer duration of the drug efficacy|Month 12 and Month 24|Full analysis set with use of LOCF consisted of all patients who received at least 1 administration of study treatment and had at least 1 post-baseline assessment for BCVA in the study eye. The number of patients shown was with a value at treatment interruption and an average for the post treatment interruption visits.||Letters||Standard Deviation|Mean
682969|NCT01535261|Secondary|Mean Average Change in Best Corrected Visual Acuity (BCVA From Baseline Month 12 and Month 24|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. Mean Average Change: for each patient, first average change is calculated as the average of the changes from baseline to Month 1 over Month 12 (or Month 24). Then, mean average change is calculated as the average of average changes across all patients.|Baseline and Month 1 to 12 or Month 24|The Full analysis set (FAS) with use of Last Observation Carried Forward (LOCF) consisted of all patients who received at least 1 administration of study treatment and had at least 1 post-baseline assessment for BCVA in the study eye. One patient was excluded from the FAS for not having ≥ 1 post-baseline study eye VA assessment.||letters||Standard Deviation|Mean
682970|NCT01535261|Secondary|Mean Change in Best Corrected Visual Acuity (BCVA) at Month 24 Compared to Baseline|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. A positive average change from baseline of BCVA indicates improvement|Baseline to Month 24|The Full analysis set (FAS) with use of Last Observation Carried Forward (LOCF) consisted of all patients who received at least 1 administration of study treatment and had at least 1 post-baseline assessment for BCVA in the study eye. One patient was excluded from the FAS for not having ≥ 1 post-baseline study eye VA assessment.||Letters||Standard Deviation|Mean
682971|NCT01535261|Primary|Mean Change in Best Corrected Visual Acuity (BCVA) at Month 12 Compared to Baseline|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. A positive average change from baseline of BCVA indicates improvement|Baseline to month 12|The Full analysis set (FAS) with use of Last Observation Carried Forward (LOCF) consisted of all patients who received at least 1 administration of study treatment and had at least 1 post-baseline assessment for BCVA in the study eye. One patient was excluded from the FAS for not having ≥ 1 post-baseline study eye VA assessment.||Letters||Standard Deviation|Mean
682972|NCT01535235|Secondary|Change in HIV DNA (Copies/Million Rectal Cells)|Change in HIV DNA measured in GALT (gut-associated lymphoid tissue) from baseline|22 weeks|Three participants in the placebo group did not have sufficient cells for analysis for one of the time points.||copies/million rectal cells||Inter-Quartile Range|Median
682976|NCT01535118|Secondary|Percentage of Participants Who Received Allergy Shots and Had a Co-morbid Condition of Asthma|Participants were asked about co-morbid health conditions. The percentage of participants who had received allergy shots to treat ARC and had asthma was calculated.|Within 12 months prior to survey|The analysis population consisted of all participants who responded to the survey and received allergy shots.||percentage of participants|||Number
682977|NCT01535118|Primary|Percentage of Participants Who Received Allergy Shots and Required Supplemental Prescription Allergy Medication|Participants who received subcutaneous immunotherapy (allergy shots) were asked about prescription and over-the-counter medication use. The percentage of participants who received allergy shots to treat ARC, had not taken over-the-counter allergy medication and required supplemental prescription allergy medication for ARC was calculated.|Within 12 months prior to survey|The analysis population consisted of all participants who responded to the survey, received immunotherapy (allergy shots) and had not taken over-the-counter allergy medication.||percentage of participants|||Number
682978|NCT01535118|Primary|Percentage of Participants Who Received Immunotherapy to Treat ARC|Participants who had ever received immunotherapy for ARC were asked about the type of immunotherapy - subcutaneous or sublingual - received. The percentage of participants who received immunotherapy to treat ARC was calculated.|Within 12 months prior to survey|The analysis population consisted of all participants who responded to the survey.||percentage of participants|||Number
682979|NCT01535118|Primary|Percentage of Participants Who Used Medication to Treat ARC in the Past 12 Months|Participants were asked about prescription and over-the-counter medication use for ARC. The percentages of participants who used prescription and/or over-the-counter medication to treat ARC in the past 12 months were calculated.|Within 12 months prior to survey|The analysis population consisted of all participants who responded to the survey.||percentage of participants|||Number
682980|NCT01535118|Primary|Percentage of Participants Who Experienced Work or School Absence Due to ARC in the Past 12 Months|Participants were asked about the impact of ARC on loss of work and school time. The percentage of participants who experienced work or school absence due to ARC in the prior 12 months was calculated.|Within 12 months prior to survey|The analysis population consisted of all participants who responded to the survey.||percentage of participants|||Number
682981|NCT01535118|Primary|Percentage of Participants Who Experienced Daily Symptoms Due to Allergic Rhinoconjunctivitis (ARC)|Participants were asked about the frequency and severity of ARC symptoms when allergies were at their worst. The percentages of participants who experienced different symptoms of ARC on a daily basis when allergies were at their worst were calculated.|Within 12 months prior to survey|The analysis population consisted of all participants who responded to the survey.||percentage of participants|||Number
682982|NCT01535040|Secondary|Smoking Withdrawal|The Wisconsin Smoking Withdrawal Scale is a 28 item questionnaire that assesses nicotine withdrawal. It consists of seven subscales, each consisting of 3-5 questions all answered on a 0-4 scale. Subscale scores are the mean of the items comprising the scale. Some items are reverse scored. Higher scores indicate greater withdrawal symptoms. Subscales were scored if more than half the items were answered. A total score was calculated as the mean of the individual subscales (if more than half the subscales had scores).|12 weeks|Participants who provided data at any time||units on a scale||Standard Error|Least Squares Mean
682983|NCT01535040|Secondary|Nicotine Dependence|The Fagerstrom tolerance scale consists of 8 questions, each of which is scored on a 0 to 1 or 0 to 2 scale. The total score ranges from 0 to 11, with higher scores representing greater dependence.|12 weeks|Participants who reported any data||units on a scale||Standard Error|Least Squares Mean
682984|NCT01535040|Primary|Adherence|Adherence is the percentage of prescribed pills taken while on therapy.|12 weeks|Participants who returned pill diaries.||percentage of prescribed pills||Full Range|Mean
682985|NCT01535040|Primary|Retention|Retention is defined as the percentage of participants who complete the 12 week visit|12 weeks|All randomized participants||percentage of participants||95% Confidence Interval|Number
682995|NCT01534962|Secondary|Number of Patients in Sinus Rhythm 48 Hours After Cardioversion With Documented AF Recurrence|Documented AF recurrences in those patients who did not experience early relapses (within 48 hours after cardioversion)|16 weeks (112 days)|Modified Intention-to-Treat Population (N=217) excluding 21 patients with AF relapse within 48 hours post cardioversion||participants|||Number
682996|NCT01534962|Secondary|Time From Randomization to First Documented AF Recurrence in Patients With Sinus Rhythm 48 Hours After Cardioversion|Excluding patients with early relapses (within 48 hours) while the study drug, started after cardioversion, had not yet reached steady-state.|16 weeks (112 days)|Modified Intention-to-Treat Population (N=217) excluding 21 patients with AF relapse within 48 hours post cardioversion||Days||95% Confidence Interval|Median
682997|NCT01534962|Secondary|Number of Patients With Documented and Confirmed AF Recurrences||16 weeks (112 days)|Intention-to-Treat||participants|||Number
682998|NCT01534962|Secondary|Time From Randomization to First Documented and Confirmed AF Recurrence|A confirmed AF recurrence was defined as a documented AF recurrence which was confirmed by a consecutive ECG performed at least 1 hour after first AF documentation.|16 weeks (112 days)|Intention-to-Treat (N=238)||Days||95% Confidence Interval|Median
682999|NCT01534962|Secondary|Number of Patients With Documented AF Recurrences||16 weeks (112 days)|Intention-to-Treat (N=238)||participants|||Number
683000|NCT01534962|Primary|Time From Randomization to First Documented AF Recurrence.|"Time to first AF recurrence reported by patient-reported TT-ECG or 12-Lead ECG at the study site, whichever occurred first.
Patients discontinuing the study without AF were censored at the time of the last available ECG."|16 weeks (112 days)|Intention-to-treat-approach that analyzed all randomised patients who took at least one dose of study medication (N=238, i.e. excluding 3 randomized patients).||Days||95% Confidence Interval|Median
683001|NCT01534910|Secondary|Coronary Calcium|Agatston score is a semi-automated tool to calculate a score based on the extent of coronary artery calcification detected by an unenhanced low-dose CT scan. The calculation is based on the weighted density score given to the highest attenuation value (HU) multiplied by area of the calcification speck. The grading of coronary artery disease (based on total calcium score) is as follows: no evidence of CAD: 0 calcium score, minimal: 1-10, mild: 11-100, moderate: 101-400, and severe: >400|1 year|patients undergoing two calcium scores||agatston units||95% Confidence Interval|Mean
683002|NCT01534910|Primary|CT Angiography Plaque|"we will measure low attenuation plaque at baseline (in volume) and then again at 1 year. we will assess if there is a reduction in low attenuation plaque volume (percent change from baseline), defined as [followup-baseline]/baseline x100%.
Baseline was time zero, followup CT scan was 1 year."|baseline to 1 year|||percent change of low attenuation plaque||Standard Deviation|Mean
683003|NCT01534897|Secondary|Clinical Benefit as Measured by Change in Thyroglobulin Level|To evaluate clinical benefit as measured by change in serum tumor marker, thyroglobulin. Rising thyroglobulin is generally indicative of tumor growth.|3 months after radioiodine therapy|||Participants|||Count of Participants
683004|NCT01534897|Secondary|Number of Participants Who Complete the Study With Minimal Delays and no Dose Reductions|To determine the feasibility of: (a) administering GSK2118436 for 28 days in patients with BRAF V600E-mutant PTC, prior to whole body iodine scanning (all patients); and (b) administering GSK2118436 for an additional 14 days, prior to administering treatment doses of radioactive iodine (patients whose tumors demonstrate significant iodine uptake after 28 days of treatment).|2 years|||Participants|||Count of Participants
683005|NCT01534897|Secondary|Clinical Benefit as Measured by Change in Tumor Size|To evaluate clinical benefit as measured by objective response rate per modified RECIST 1.1, which assesses changes in size of measurable tumors. (per RECIST, a partial response (PR) = at least 30% decrease in size of tumor; progressive disease (PD) = at least 20% increase in size of tumor; stable disease (SD) = neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD).|2 years|||Participants|||Count of Participants
683006|NCT01534897|Secondary|Safety Analysis as Number of Participants With Adverse Events|To evaluate the safety and tolerability, as determined by adverse event and serious adverse event reporting, of GSK2118436 in combination with whole body iodine scans (all patients) and treatment doses of radioactive iodine (patients whose tumors demonstrate significant iodine uptake).|2 years|All patients completed dabrafenib without dose modification.||Participants|||Count of Participants
683007|NCT01534897|Primary|Increased Radioiodine Uptake|Number of patients with radioiodine-refractory metastatic BRAF V600E-mutant PTC who have increased radioiodine uptake in their disease sites while on dabrafenib. Radioiodine uptake is assessed by whole body scan and areas of interest are identified by nuclear medicine physicians.|25 days after start of Dabrafenib (GSK2118436)|||Participants|||Count of Participants
683008|NCT01534689|Secondary|Change in Percent (%) of mm Clear Nail|Millimeter (mm) of clear nail from the base of the lunula was measured from digital photographs of the toenail using a computer program. Change in mm of clear nail bed was calculated as the difference in mm of clear nail bed from baseline measurement to the measurement at 3 months post-procedure administration. The percent (%) of increase in clear nail from baseline was calculated from there.|12 weeks|||percentage of change in mm clear nail||Standard Deviation|Mean
683009|NCT01534689|Secondary|Change in Millimeter (mm) of Clear Nail Bed|Millimeter (mm) of clear nail from the base of the toenail lunula was determined from digital photographs of the toenail using a computer program. Change in mm of clear nail bed was calculated as the difference in mm of clear nail bed from baseline measurement to the measurement at 3 months post-procedure administration. An increase in mm of clear nail between the two measurement points indicates that the toenail onychomycosis has improved and is positive for study success. A decrease in mm of clear nail between the two measurement points indicates that the toenail onychomycosis has worsened and is negative for study success.|12 weeks|||millilmeters||Standard Deviation|Mean
683010|NCT01534689|Primary|Proportion of Toenails Attaining 25 Percent (%) or More Increase in Clear Nail|"Millimeter (mm) of clear nail from the base of the lunula was measured from digital photographs of the toenail using a computer program. Change in mm of clear nail bed was calculated as the difference in mm of clear nail bed from baseline measurement to the measurement at 3 months post-procedure administration. The percent (%) of increase in clear nail from baseline was calculated from there. An increase in mm or percent of clear nail between the two measurement points indicates the toenail onychomycosis has improved and is positive for study success. A decrease in mm or percent of clear nail between the two measurement points indicates the toenail onychomycosis has worsened and is negative for study success.
Individual toenail success criteria was defined as 25 percent (%) or more increase in clear nail growth at 3 months post-procedure relative to baseline. Overall study success criteria was defined as 60% or more of treated toenails meeting the individual success criteria."|12 weeks|||percentage of toenails|||Number
683011|NCT01534676|Primary|Non-transferrin-bound Iron Level||2 hours after transfusion|Enrolled participants (recipients) were never randomized or received transfusion on study because study closed due to poor enrollment. No data was collected or analyzed.|||||
683012|NCT01534637|Secondary|Impact of Aprepitant/5HT-3 Antagonist Therapy on the Patient Quality of Life as Measured by the Number of Patients Taking Anti Nausea Drugs||Week 5|||participants|||Number
683013|NCT01534637|Secondary|Impact of Aprepitant/5HT-3 Antagonist Therapy on the Patient Quality of Life as Measured by the Number of Patients Using Anti Nausea Drugs||Week 1|||participants|||Number
683014|NCT01534637|Primary|Number of Patients With Gastrointestinal Toxicities (Grade 3 and 4 Nausea and Vomiting) Associated With Delivering Fluorouracil/Gemcitabine Hydrochloride-based Chemotherapy With Upper Abdominal Radiation|Toxicity will be determined using the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC) version 3.0 for Toxicity and Adverse Event Reporting. Descriptive statistics (means, standard deviations, frequencies, etc.) will be presented for pretreatment patient characteristics. The rate of grade 3 and 4 nausea will be compared to the cut points during interim and final analyses.|Over 10 weeks|||participants|||Number
683015|NCT01534533|Secondary|Dietary Intake of Vitamin C,Vitamin E, Lutein Plus Zeaxanthin and Lycopene During the Study Periods|Dietary intake of Vitamin C,Vitamin E, Lutein plus zeaxanthin and Lycopene was assessed at baseline and after 12months by using 3 consecutive 24-hour recalls.|at baseline and 12 months||12/3333||||
683016|NCT01534533|Secondary|Dietary Intake of Energy During the Study Periods|Dietary intake was assessed at baseline and after 12months by using 3 consecutive 24-hour recalls.|at baseline and 12 months||12/3333||||
683017|NCT01534533|Secondary|Changes of Right Common Carotid Arterial Stiffness Parameter β(R-β) at Baseline and After 12 Months|Arterial stiffness was measured by using a high-resolution B-mode carotid ultrasound with echo-tracking system (Aloka prosound α-10, Aloka Co. Ltd., Tokyo, Japan).|at baseline and after 12 months||12/3333||||
683018|NCT01534533|Primary|Table 1 Study Specific Characteristic of Serum Carotenoids|serum major carotenoids, including lutein, zeaxanthin, beta-carotene, and lycopene concentration were measured by hyper-pressure liquid chromatography (HPLC)|at baseline|We conducted a per protocol analysis of all the subjects who completed the study.||μg/ml||Standard Deviation|Mean
683019|NCT01534533|Primary|Table 1 Study Specific Characteristic of Blood Pressure (BP)|systolic BP and diastolic BP in four groups was measure twice between 15minutes|at baseline|We conducted a per protocol analysis of all the subjects who completed the study.||mm Hg||Standard Deviation|Mean
683020|NCT01534533|Primary|Table 1 Study Specific Characteristic of Body Mass Index (BMI)|the mean and standard deviation of BMI in four groups was calculated|at baseline|We conducted a per protocol analysis of all the subjects who completed the study.||Kg/m^2||Standard Deviation|Mean
683021|NCT01534533|Primary|Table 1 Study Specific Characteristic of Age|the mean and standard deviation of age was calculated in four groups|at baseline|We conducted a per protocol analysis of all the subjects who completed the study.||years||Standard Deviation|Mean
683022|NCT01534533|Primary|Table 1 Study Specific Characteristic Part One|The percentage of female, race, hypertenion history, diabetes history, and hyperlipemia history was calculated.|at baseline|We conducted a per protocol analysis of all the subjects who completed the study.||Percentage of Participants|||Number
683023|NCT01534520|Secondary|Need for Pain Medication up to 7 Days|Number of women taking pain medication for at least one day following IUD insertion|7 days post-insertion|||participants|||Number
683024|NCT01534520|Secondary|Percentage of IUDs Considered by Physicians Easy to Insert|"The physician who conducted the study visit and IUD insertion was asked about the difficulty/ease in placing the IUD immediately following the procedure and the percentage of IUD insertions considered to be easy was calculated for each study group."|Directly after IUD insertion|Participants in each group self-administered the study gel as per instruction followed by insertion of the IUD by the physician 5 to 15 minutes later.||percentage of insertions declared easy||95% Confidence Interval|Number
683025|NCT01534520|Secondary|To Evaluate Patient Experience of Self-inserting the Intravaginal Study Gel Prior to IUD|"Number of participants who rated self-application of study gel as some what easy or very easy on Likert scale"|After inserting the gel but prior to IUD insertion|||participants who found gel easy to use|||Number
683026|NCT01534520|Primary|Change in Pain From Baseline to IUD Insertion|To assess change in pain from baseline to IUD insertion measured on a visual analog scale (VAS) from 0 mm (no pain) to 100 mm (worst pain in patient’s life). This pain assessment was prior to (baseline) and at the time of IUD insertion following vaginal self-administration of study gel (either 2% lidocaine gel or placebo gel).|change in pain score from baseline (before IUD insertion) to time of IUD insertion|||change in visual analog scale score||Inter-Quartile Range|Median
683027|NCT01534351|Primary|Number of Participants Who Discontinued Treatment Due to an Adverse Event|An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product.|Up to 52 weeks|All Participants as Treated (APaT) - population consists of all randomized participants who received at least one dose of study treatment. As only one participant was randomized in the study, no analyses were performed.||Participants|||Number
683028|NCT01534351|Primary|Number of Participants Who Experienced an Adverse Event|An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product.|Up to 54 weeks|||Participants|||Number
683029|NCT01534351|Primary|Percent Change From Baseline in Prostate Volume|Prostate volume was assessed by trans-rectal ultrasound (TRUS).|Baseline and Month 12|Full Analysis Set (FAS) - population consists of all randomized participants who received at least one dose of study treatment, at least one post-randomization observation for the analysis endpoint, and baseline data for those analyses that require baseline data. As only one participant was randomized in the study, no analyses were performed.|||||
683030|NCT01534351|Primary|Change From Baseline in International Prostate Symptom Score (IPSS)|The IPSS is a self-administered questionnaire used to measure the severity of lower urinary tract symptoms among men suspected of having symptomatic Benign Prostatic Hyperplasia (BPH). The IPSS consists of 8 questions (7 urinary symptom questions + 1 quality of life question). The 7 symptom questions inquire about frequency, nocturia, weak urinary stream, hesitancy, intermittence, incomplete emptying and urgency. Each of the 7 questions has an ordered categorical response frame scored from 0 (not at all) to 5 (almost all the time). The total score is the sum of the 7 items and therefore has a range of 0 to 35. Higher scores indicate higher symptom severity. The quality of life question is a single global question rated on a scale of 0 (delighted) to 6 (terrible) asking the participant to rate how they feel about their current urinary symptom status. The IPSS-QoL question is not used in the calculation of the total symptom score.|Baseline and Month 12|Full Analysis Set (FAS) - population consists of all randomized participants who received at least one dose of study treatment, at least one post-randomization observation for the analysis endpoint, and baseline data for those analyses that require baseline data. As only one participant was randomized in the study, no analyses were performed.|||||
683031|NCT01534208|Primary|Change From Baseline in FSH|Change from baseline in FSH at end of treatment (26 weeks)|6 months|||U/L||Standard Deviation|Mean
683032|NCT01534208|Primary|Change From Baseline in BMI|Mean change from baseline in BMI at end of treatment (26 weeks)|6 months|ITT||kg/m2||Standard Deviation|Mean
683033|NCT01534208|Primary|Mean Change From Baseline FPG|Mean changes in Fasting Plasma Glucose from baseline to end of treatment (26 weeks)|6 months|||mg/dL||Standard Deviation|Mean
683034|NCT01534208|Primary|Absolute Values of Morning Testosterone|Absolute values of morning testosterone at end of treatment (26 weeks)|6 months|ITT||ng/dL||Standard Deviation|Mean
683035|NCT01534208|Primary|Change From Baseline in LH|Mean change from baseline in LH at end of treatment (26 weeks)|6 months|ITT||mIu/mL||Standard Deviation|Mean
683036|NCT01534208|Primary|Change From Baseline in Total Morning Testosterone at 26 Weeks|Changes in values from baseline of total morning testosterone levels at Week 26|6 months|Intent to Treat population||ng/dL||Standard Deviation|Mean
683037|NCT01534182|Secondary|Change in Patient-reported Health-related Quality-of-life Using the Short Form Health Survey v2 Acute (SF-36 v2 Acute)|The SF-36 is a health-related quality of life instrument used in numerous disease states, including MS (Brazier et al 1992). It is a self-administered survey that measures 8 domains of health including: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems and general mental health. Two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Each domain was scored by adding the individual items from the domain and transforming the resulting scores into a 0 to 100 scale with higher scores indicating better health status or functioning.|Baseline, 6 months|Participants from the full analysis set were considered for this analysis. However, for a given time frame, participants analyzed had both baseline and 6 month asssessment values.||scores on scale||Standard Deviation|Mean
683038|NCT01534182|Secondary|Change in Patient-reported Depression|The Beck Depression Inventory (BDI-I) scale was used to measure this outcome. The scale consists of 21 items to assess the intensity of depression in clinical and normal patients. Each item is a list of four statements arranged in increasing severity about a particular symptom of depression. Each item was scored from 0 - 3. If more than one score was provided for an item, the maximum score was considered the item score. The total score was calculated as the sum of all individual items and then compared to a key to determine the depression's severity. The standard key ranges were: 0 - 9 indicated minimal depression; 10 - 18 indicated mild depression; 19 - 29 indicated moderate depression and 30 - 63 indicated severe depression. Higher total scores indicate more severe depressive symptoms.|Baseline, 6 months|FAS: The LOCF method was applied.||scores on a scale||Standard Deviation|Mean
683039|NCT01534182|Secondary|Changes in Patient-reported Effectiveness, Side Effects and Convenience|TSQM v 1.4 domains for effectiveness, side effects and convenience were used to evaluate this outcome. The effectiveness domain for items 1 - 3 was scored as: 1 (extremely dissatisfied) to 7 (extremely satisfied). For the side effects domain, item 4 scored as 0(no) or 1(yes); item 5 scored as 1 (extremely bothersome) to 5 (not at all bothersome); and items 6 - 8 scored as 1 (a great deal) to 5 (not at all). For the convenience domain, items 9 and 10 scored as 1(extremely difficult) to 7 (extremely easy), and item 11 scored as 1 (extremely inconvenient) to 7 (extremely convenient). For each domain, scale scores were computed by adding the items loading on each domain. The lowest possible score was subtracted from the composite score and divided by the greatest possible score range. This provided a transformed score between 0 and 1 that was then multiplied by 100. The final transformed score ranges from 0 to 100, with higher scores indicating better treatment satisfaction.|Baseline, 6 months|FAS: The LOCF method was applied.||scores on a scale||Standard Deviation|Mean
683040|NCT01534182|Secondary|Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Death|Participants were monitored for adverse events, serious adverse events and death throughout the study.|6 months|Safety Set: This set included all randomized participants who received at least one dose of study medication.||Participants|||Number
683041|NCT01534182|Primary|Change in Patient-reported Treatment Satisfaction|The Treatment Satisfaction Questionnaire for Medication (TSQM) contains 14 items assessing the following 4 domains: effectiveness (items 1 - 3), side effects (items 4 - 8), convenience (items 9 - 11) and global satisfaction (items 12 - 14). The primary outcome was measured on the global satisfaction domain. Item 12 scored as 1 (not at all confident) to 5 (extremely confident); item 13 scored as 1 (not at all certain) to 5 (extremely certain); and item 14 scored as 1 (extremely dissatisfied) to 7 (extremely satisfied). Responses to items were summed and transformed: specifically, TSQM v 1.4 domain scale scores were computed by adding the items loading on each domain. The lowest possible score was subtracted from the composite score and divided by the greatest possible score range. This provided a transformed score between 0 and 1 that was then multiplied by 100. The final transformed score ranges from 0 to 100, with higher scores indicating better treatment satisfaction.|Baseline, 6 months|Full Analysis Set (FAS): This set included all randomized participants who had taken at least one dose of study medication and had at least one post-baseline assessment of the TSQM. The last observation carried forward (LOCF) method was applied.||scores on a scale||Standard Deviation|Mean
683042|NCT01534143|Secondary|Recovery of T-cell, B Cell and NK Cell Phenotypes||Days 30, 60, 90, and at 6 months after transplant||||||
683043|NCT01534143|Secondary|Progression Free Survival||From the day of transplant to progression, death, or last contact, assessed up to 2 years||||||
683044|NCT01534143|Secondary|Overall Survival||Up to 2 years post transplant||||||
683045|NCT01534143|Secondary|Incidence of Opportunistic Infections Including CMV, HSV, and EBV Reactivation||Weekly to day 100||||||
683046|NCT01534143|Secondary|Incidence and Severity of Chronic GVHD||Up to 2 years post transplant||||||
683047|NCT01534143|Secondary|Incidence of SOS||Up to 2 years post transplant||||||
683048|NCT01534143|Secondary|Incidence of TTP||Up to 2 years post transplant||||||
683049|NCT01534143|Secondary|Incidence of Transplant Related Mortality and Morbidity||Up to 2 years post transplant||||||
683050|NCT01534143|Secondary|Incidence of Myeloma Progression||Time to the first observation of disease progression/relapse post transplant, assessed up to 2 years post transplant||||||
683051|NCT01534143|Primary|Grade III and IV Non Hematologic Toxicities|Based on NCI CTCAE version 4.|First 6 months post transplant||||||
683052|NCT01534143|Primary|Treatment Related Mortality Defined as Death in Continuous or Complete Remission|Based on National Cancer Institute (NCI) CTCAE version 4.|From the date of transplant to the date of death, assessed up to 6 months post transplant||||||
683053|NCT01534143|Primary|Time to Platelet Absolute Neutrophil Recovery (Engraftment)|Estimated using Kaplan-Meier method.|First 6 months post-transplant||||||
683054|NCT01534143|Primary|Incidence and Severity of Acute GVHD Using Fludarabine Phosphate / Busulfan / Bortezomib Preparative Regimen and Triple Immune Suppression With Tacrolimus, Sirolimus and Anti-thymocyte Globulin|Graded using the Glucksberg scale. Proportions and confidence intervals will be estimated. Estimated using binary proportion estimates as well as competing risk method.|First 6 months post-transplant|Data was not collected, because funding was unavailable to continue study.|||||
683055|NCT01534078|Secondary|Grade III or IV Adverse Events|A summary of the grade 3 or 4 adverse events experienced by participants as determined by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The data is shown as the number of participants that experienced at least one grade 3 or 4 adverse event for each of the specified toxicities.|2 years|||participants|||Number
683056|NCT01534078|Secondary|Overall Response Rate|"The number of participants achieving a Partial Response (PR) or Complete Response (CR) at the end of therapy as measured via PET/CT response. Response is evaluated using the Revised International Working Group Criteria.
CR: Disappearance of all evidence of disease
PR: Regression of measurable disease and no new sites"|End of Therapy (median duration of four months)|Two participants were not evaluated for response due to a death and a withdrawal.||Participants|||Count of Participants
683057|NCT01534078|Secondary|Overall Response Rate After One Cycle of Brentuximab|"The number of participants achieving a Partial Response (PR) or Complete Response (CR) after one cycle of Brentuximab monotherapy as measured via PET/CT response. Response is evaluated using the Revised International Working Group Criteria.
CR: Disappearance of all evidence of disease
PR: Regression of measurable disease and no new sites"|28 days|||Participants|||Count of Participants
683058|NCT01534078|Primary|Complete Response Rate|Complete response rate at the end of therapy as measured by Positron emission tomography–computed tomography (PET/CT). Response is evaluated using Revised International Working Group Criteria. Complete response is defined as disappearance of all evidence of disease.|End of Therapy (median duration of four months)|Two participants were not evaluated for response due to a death and a withdrawal.||Participants|||Count of Participants
683059|NCT01533974|Primary|Number of Participants Who Stopped Smoking by 12 Month Post Treatment|30 day point prevalence abstinence at 12 months. Missing = smoking and self report.|12 months|||participants|||Number
683060|NCT01533935|Secondary|FEV1 (1 Hour Post-dose)|"Forced Expiratory Volume in 1 Second (FEV1) (one hour post-dose).
The presented means are adjusted means from MMRM model."|6 weeks|All patients in FAS with available FEV1 data at baseline and week 6 are included in the analysis.||Litres||Standard Error|Mean
683061|NCT01533935|Secondary|Slope of the Intensity of Breathing Discomfort (Borg Scale) During Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Wcap|"Slope of the intensity of breathing discomfort (Borg Scale) during CWRCE to symptom limitation at 75% Wcap. The intensity of breathing discomfort was rated using the modified Borg scale with ratings from 0 (nothing at all) to 10 (maximal).
Slope is defined as : (intensity of breathing discomfort at the end of exercise minus intensity of breathing discomfort at rest) / endurance time.
A decrease in slope indicates improvement.
The presented means are adjusted means from MMRM model."|6 weeks|FAS||units on a scale / s||Standard Error|Mean
683062|NCT01533935|Primary|Endurance Time During Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Wcap|"Endurance time during constant work rate cycle ergometry (CWRCE) to symptom limitation at 75% Wcap
Wcap was defined as the maximum work rate achieved for at least 30 seconds during the incremental cycle ergometry performed at Visit 1.
The presented means are adjusted mean from the MMRM model."|6 weeks|FAS||seconds||Standard Error|Geometric Mean
683080|NCT01533428|Secondary|Number of Participants Who Used Rescue Pain Medication Days 1 Through 5|Summarized number of participants who used Rescue Pain Medications for Pain|Days 1 - 5|Safety Analysis Set (SAF)||participants|||Number
683063|NCT01533935|Primary|Inspiratory Capacity at Rest Before Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Work Capacity|"Inspiratory capacity (IC) at rest before constant work rate cycle ergometry to symptom limitation at 75% maximal work capacity (Wcap).
Wcap was defined as the maximum work rate achieved for at least 30 seconds during the incremental cycle ergometry performed at Visit 1.
The presented means are adjusted means from the MMRM (Mixed Effects Model Repeated Measures) model."|6 weeks|Full Analysis Set (FAS) : This patient set included all patients in the TS who had the study baseline and at least 1 evaluable post-dose measurement for 1 of the primary endpoints. Assignment to the FAS was done after implementation of any data handling rules,which set measurements to missing.||Litres||Standard Error|Mean
683064|NCT01533922|Secondary|Forced Expiratory Volume in 1 Second (One Hour Post-dose)|"Forced Expiratory Volume in 1 Second (FEV1) (one hour post-dose)
The presented means are adjusted means from MMRM model."|6 weeks|FAS||Litres||Standard Error|Mean
683065|NCT01533922|Secondary|Slope of the Intensity of Breathing Discomfort During Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Work Capacity|"Slope of the intensity of breathing discomfort during Constant Work Rate Cycle Ergometry (CWRCE) to symptom limitation at 75% Work capacity (Wcap). The intensity of breathing discomfort was rated using the modified Borg scale with ratings from 0 (nothing at all) to 10 (maximal).
Slope of breathing discomfort is defined as: (intensity of breathing discomfort at the end of exercise minus intensity of breathing discomfort at rest) / endurance time.
A decrease in slope indicates improvement.
The presented means are adjusted means from MMRM model."|6 weeks|FAS||units on a scale / second||Standard Error|Mean
683066|NCT01533922|Primary|Endurance Time During Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Wcap|"Endurance time during constant work rate cycle ergometry (CWRCE) to symptom limitation at 75% work capacity (Wcap).
Wcap was defined as the maximum work rate achieved for at least 30 seconds during the incremental cycle ergometry performed at Visit 1.
The presented means are adjusted mean from the MMRM model."|6 weeks|FAS||seconds||Standard Error|Geometric Mean
683067|NCT01533922|Primary|Inspiratory Capacity at Rest Before Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Wcap|"Inspiratory capacity (IC) at rest before constant work rate cycle ergometry to symptom limitation at 75% maximal work capacity (Wcap).
Wcap was defined as the maximum work rate achieved for at least 30 seconds during the incremental cycle ergometry performed at Visit 1.
The presented means are adjusted means from the MMRM (Mixed Effects Model Repeated Measures) model."|6 weeks|Full Analysis Set (FAS) : This patient set included all patients in the TS who had the study baseline and at least 1 evaluable post-dose measurement for 1 of the primary endpoints. Assignment to the FAS was done after implementation of any data handling rules,which set measurements to missing.||Litres||Standard Error|Mean
683068|NCT01533753|Secondary|Assess Changes in Quality of Life Using the Hot Flash Related Daily Interference Scale (HFRDIS)|Assess percent change in quality of life from baseline to cycle 6, as measured by the Hot Flash Related Daily Interference Scale (HFRDIS) total score, between gabapentin and venlafaxine in men with prostate cancer treated for hot flashes related to androgen deprivation therapy.|over the 6 month treatment period|Zero participants analyzed due to early termination of study|||||
683069|NCT01533753|Secondary|Assess Changes in the Hot Flash Scores for the Two Arms|Assess percentage changes in the hot flash score from baseline to cycle 6 between gabapentin and venlafaxine in men with prostate cancer treated with for hot flashes related to androgen deprivation therapy|6 month treatment period|Zero participants analyzed due to early termination of study|||||
683070|NCT01533753|Secondary|Compare Toxicity Rates Between the Gabapentin and Venlafaxine Treatment Groups|Toxicity rates will be compared between the two groups|over a 6 month treatment period|Zero participants analyzed due to early termination of study|||||
683071|NCT01533753|Primary|Changes in Quality of Life|We will measure the absolute change in the Functional Assessment of Cancer Therapy-Prostate (FACT-P) total score, between gabapentin and venlafaxine in men with prostate cancer treated for hot flashes related to androgen deprivation therapy|observed over a 6 month treatment period|Zero participants analyzed due to early termination of study.|||||
683072|NCT01533597|Secondary|Change of Qmax|maximal urinary flow rate (Qmax) assessed by uroflowmetry|at week 24 relative to baseline|||mL/sec||95% Confidence Interval|Mean
683073|NCT01533597|Secondary|Change of PVR|Change from baseline in Post-Void Residual (PVR) volume|at week 24 relative to baseline|||mL||95% Confidence Interval|Mean
683074|NCT01533597|Secondary|Change in Score of IPSS|Total Score of IPSS(International Prostate Symptom Score) is the sum of 7 questions, ranging from 0 (best possible outcome) to 35 (worst possible outcome). The 7 symptom questions include feeling of incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining and nocturia, each referring to during the last month, and each involving assignment of a score from 0 to 5 for a total of maximum 35 points.|at week 24 relative to baseline|||units on a scale||95% Confidence Interval|Mean
683075|NCT01533597|Secondary|Change in Total Score of OABSS|Total Score of OABSS(Overactive Bladder Symptom Score) is the sum of 4 questions, ranging from 0 (best possible outcome) to 15 (worst possible outcome)|at week 24 relative to baseline|||units on a scale||95% Confidence Interval|Mean
683076|NCT01533597|Secondary|Numeric Change of Urgency Episodes Per 24 Hours||at week 24 relative to baseline|||episodes||95% Confidence Interval|Mean
683077|NCT01533597|Primary|Change in Mean Number of Micturition Episodes Per 24 Hours||at week 24 relative to baseline|||episodes||95% Confidence Interval|Mean
683078|NCT01533493|Primary|Percent Change in Global Executive Composite T-Score on the Behavior Rating Inventory of Executive Function-Adult (BRIEF-A)|"This is a 75-item checklist with a large normative sample, internal consistency, test-retest reliability, inter-rater reliability, and external and concurrent validity, divided into nine empirically and theoretically derived and T-scored subscales: Inhibit, Shift, Emotional Control, Self-Monitor, Initiate, Working Memory, Plan/Organize, Task Monitor, and Organization of Materials. Example item: I make careless errors when completing tasks. Items are rated 1 Never, 2 Sometimes, or 3 Often. The Global Executive Composite (GEC) Score is calculated by totaling all items on the scale. GEC T-scores range from 34-108, with higher scores indicating more difficulties with executive function."|baseline, 12 weeks|||percentage change from baseline score||Standard Deviation|Mean
683079|NCT01533428|Secondary|Safety Assessed Through Adverse Events (AE) and Serious Adverse Events (SAE), Vital Signs, and Laboratory Analyses From Baseline to Week 12|Number of patients assessed for Safety through Adverse Events (AE) and Serious Adverse Events (SAE), vital signs, and laboratory analyses from baseline to week 12|Baseline to Week 12|Safety Analysis Set (SAF)||participants|||Number
683081|NCT01533428|Secondary|"Change From Pre-application inPain Now Score"|"Change from pre-application inPain Now score was measured on a scale from 0-10 where 0 equates to No Pain and 10 to Pain as bad as you can imagine. Participants were asked to provide pain ratings relative only to the area of pain undergoing treatment."|Pre-application and 15 minutes and 60 minutes after patch removal|Safety Analysis Set (SAF)||units on a scale||Standard Deviation|Mean
683082|NCT01533428|Secondary|Tolerability of Patch Application Assessed by Dermal Assessment on Day 1, 15 Minutes and 60 Minutes After Patch Removal.|Tolerability of patch application was assessed by dermal assessment (0 to 7 point severity score on Dermal Assessment Scale). Data reported is based on the number of participants in the combined category with a score ≥ 4 (Definite edema or higher), 15 and 60 minutes after patch removal.|Day 1, 15 minutes and 60 minutes after patch removal|Safety Analysis Set (SAF)||participants|||Number
683083|NCT01533428|Secondary|Percent Change in Average Sleep Interference Score From Baseline to Between Weeks 2-8 and Weeks 2-12|"Percent change in average sleep interference was measured by Question 9F of the Brief Pain Inventory-Diabetic Neuropathy (BPI DN) and was used to assess pain and sleep interference index. Daily sleep interference rating scale consists of an 11-point numerical scale with which the patient describes how pain related to diabetes has interfered with their sleep during the past 24 hours. On a scale 0 identifies “pain does not interfere with sleep” and 10 identifies “pain completely interferes with sleep. Average sleep interference score is assessed from baseline to Weeks 2-8 and Weeks 2-12."|Baseline, Weeks 2-8 and Weeks 2-12|Intention to Treat (ITT); Baseline Last Observation Carried Forward (BLOCF) imputation was used.||percentage of change||Standard Deviation|Mean
683084|NCT01533428|Secondary|Treatment Satisfaction Assessment Based on Self-Assessment of Treatment (SAT II) Questionnaire at Baseline, Weeks 8 and 12|"Treatment satisfaction assessment based on Self-Assessment Treatment (SAT II) questionnaire and the question Over the past 7 days, how much has the study treatment improved your pain level?"|Baseline, Weeks 8 and 12|Intention to Treat (ITT); Baseline Last Observation Carried Forward (BLOCF) imputation was used.||participants|||Number
683085|NCT01533428|Secondary|Change in Hospital Anxiety and Depression Scale (HADS) Depression Scale From Baseline to Weeks 2, 8 and 12.|The Hospital Anxiety and Depression Scale (HADS) is a self-report scale developed for the assessment of anxiety and depression, it contains 14 items rated on a 4-point Likert-type scale. There are 2 subscales,one assessing depression and the other anxiety. The 7-item depression and anxiety subscales yield scores of 0 to 21 that are interpreted with the following cut-off points: 0 to 7, normal; 8 to 10, mild mood disturbance; 11 to 14, moderate mood disturbance; and 15 to 21, severe mood disturbance.|Baseline to Weeks 2, 8 and 12|Intention to Treat (ITT); Baseline and Last Observation Carried Forward (BLOCF) imputation was used.||units on a scale||Standard Deviation|Mean
683086|NCT01533428|Secondary|Change in Hospital Anxiety and Depression Scale (HADS) Anxiety Scale From Baseline to Weeks 2, 8 and 12|The Hospital Anxiety and Depression Scale (HADS) is a self-report scale developed for the assessment of anxiety and depression, that contain 14 items rated on a 4-point Likert-type scale. There are 2 subscales,one assessing depression and the other anxiety. The 7-item depression and anxiety subscales yield scores of 0 to 21 that are interpreted with the following cut-off points: 0 to 7, normal; 8 to 10, mild mood disturbance; 11 to 14, moderate mood disturbance; and 15 to 21, severe mood disturbance.|Baseline to Weeks 2, 8 and 12|Intention to Treat (ITT); Baseline and Last Observation Carried Forward (BLOCF) imputation was used.||units on a scale||Standard Deviation|Mean
683087|NCT01533428|Secondary|Change From Baseline in the European Quality Of Life (QOL) Questionnaire in 5 Dimensions (EQ-5D) With Visual Analog Scale (VAS) to Weeks 2, 8 and 12|Change from Baseline in the European Quality Of Life (QOL) questionnaire in 5 dimensions (EQ-5D) with Visual Analog Scale (VAS) to Weeks 2, 8 and 12. EQ-5D self-reported questionnaire is used to measure health-related quality of life by measuring 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D questionnaire includes a visual analog scale (VAS) which records participants self-rated health status on a graduated (0–100) scale with higher scores indicating higher Health-Related Quality of Life (HRQoL).|Baseline to Weeks 2, 8 and 12|Intention to Treat (ITT); Baseline and Last Observation Carried Forward (BLOCF) imputation was used.||units on a scale||Standard Deviation|Mean
683088|NCT01533428|Secondary|Overall Participant Status Assessed Using Patient Global Impression of Change (PGIC) Self-assessment Questionnaire in Week 12|Overall participant status assessed using Patient Global Impression of Change (PGIC) self-assessment questionnaire which was used by participants to report on 7 categories listed as follows; Very Much Improved, Much Improved, Minimally Improved, No Change, Minimally Worse, Much Worse and Very Much Worse in Week 12|Baseline to Week 12|Intention to Treat (ITT); Baseline Last Observation Carried Forward (BLOCF) imputation was used.||participants|||Number
683089|NCT01533428|Secondary|Overall Participant Status Assessed Using Patient Global Impression of Change (PGIC) Self-assessment Questionnaire in Week 8|Overall participant status assessed using Patient Global Impression of Change (PGIC) self-assessment questionnaire which was used by participants to report on 7 categories listed as follows; Very Much Improved, Much Improved, Minimally Improved, No Change, Minimally Worse, Much Worse and Very Much Worse in Week 8|Baseline to Week 8|Intention to Treat (ITT); Baseline Last Observation Carried Forward (BLOCF) imputation was used.||participants|||Number
683090|NCT01533428|Secondary|Overall Participant Status Assessed Using Patient Global Impression of Change (PGIC) Self-assessment Questionnaire in Week 2|Overall participant status assessed using Patient Global Impression of Change (PGIC) self-assessment questionnaire which was used by participants to report on 7 categories listed as follows; Very Much Improved, Much Improved, Minimally Improved, No Change, Minimally Worse, Much Worse and Very Much Worse in Week 2|Baseline to Week 2|Intention to Treat (ITT); Baseline Last Observation Carried Forward (BLOCF) imputation was used.||participants|||Number
683091|NCT01533428|Secondary|Percentage of Participants With 50% Reduction in Average Daily Pain Score.|Percentage of participants achieving 50% decrease in the average daily pain score in Weeks 2 and 8 and Weeks 2 and 12 measured using Question 5 of the Brief Pain Inventory-Diabetic Neuropathy (BPI-DN). Participants assessed their pain on a numeric rating scale from 0 (no pain) to 10 (pain as bad as you can imagine).|Baseline, Weeks 2-8 and Weeks 2-12|Intention to Treat (ITT ); Baseline last observation carried forward(BLOCF) imputation was used.||percentage of participants|||Number
683322|NCT01529268|Secondary|Reduction in MRI-determined Hepatic Fat Fraction|Change from baseline in MRI Proton Density Fat Fraction (PDFF) (%).|52 weeks|The smaller number of observations is because MRI was an optional procedure. This is the number with MRI exams at both baseline and 52 weeks.||percentage of PDFF||Standard Deviation|Mean
683092|NCT01533428|Secondary|Percentage of Participants With 30% Reduction in Average Daily Pain Score.|Percentage of participants achieving 30% decrease in the average daily pain score in Weeks 2 and 8 and Weeks 2 and 12 measured using Question 5 of the Brief Pain Inventory-Diabetic Neuropathy (BPI-DN). Participants assessed their pain on a numeric rating scale from 0 (no pain) to 10 (pain as bad as you can imagine).|Baseline, Weeks 2-8 and Weeks 2-12|Intention to Treat (ITT ); Baseline last observation carried forward(BLOCF) imputation was used.||percentage of participants|||Number
683093|NCT01533428|Secondary|Weekly Average of Average Daily Pain at Baseline and Every Week After Baseline|Weekly average of average daily pain score at Baseline and Weeks 2,4,8 and 12 measured using Question 5 of the Brief Pain Inventory-Diabetic Neuropathy (BPI-DN). Participants assessed their pain due to diabetes in the last 24 hours on a numeric rating scale from 0 (no pain) to 10 (pain as bad as you can imagine).|Baseline and Weeks 2, 4, 8 and 12|Intention to Treat (ITT); Baseline Last Observation Carried Forward (BLOCF) imputation was used.||units on a scale||Standard Deviation|Mean
683094|NCT01533428|Secondary|Weekly Percent Change From Baseline in Average Daily Pain Score|Weekly Percent Change from baseline in average daily pain score from baseline to Week 12 measured using Question 5 of the Brief Pain Inventory-Diabetic Neuropathy (BPI-DN). Participants assessed their pain due to diabetes in the last 24 hours on a numeric rating scale from 0 (no pain) to 10 (pain as bad as you can imagine).|Baseline to Weeks 2, 3, 4, 5, 6, 7, 8, 9,10, 11 and 12|Intention to Treat (ITT ); Baseline last observation carried forward (BLOCF) imputation was used.||percentage change||Standard Deviation|Mean
683095|NCT01533428|Secondary|Percent Change in the Average Daily Pain Score From Baseline to Between Weeks 2 and 12|Percent Change in the Average Daily Pain Score from baseline to between Weeks 2 and 12 measured using Question 5 of the Brief Pain Inventory-Diabetic Neuropathy (BPI-DN). Participants assessed their pain due to diabetes in the last 24 hours on a numeric rating scale from 0 (no pain) to 10 (pain as bad as you can imagine).|Baseline to between Weeks 2 and 12|Intention to Treat (ITT); Baseline Last Observation Carried Forward (BLOCF) imputation was used.||percentage change||Standard Deviation|Mean
683096|NCT01533428|Primary|Percent Change in the Average Daily Pain Score From Baseline to Between Weeks 2 and 8|Percent change in the average daily pain score from baseline to between Weeks 2 and 8, measured using Question 5 of the Brief Pain Inventory-Diabetic Neuropathy (BPI-DN). Participants assessed their pain due to diabetes in the last 24 hours on a numeric rating scale from 0 (no pain) to 10 (pain as bad as you can imagine).|Baseline to between Weeks 2 to 8|Intention to Treat (ITT); Baseline Last Observation Carried Forward (BLOCF) imputation was used.||percentage change||Standard Deviation|Mean
683097|NCT01533259|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 24 and 48|The FDA-defined Snapshot algorithm was used, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time.|Weeks 24 and 48|Full Analysis Set||percentage of participants||95% Confidence Interval|Number
683098|NCT01533259|Secondary|Percentage of Participants With Adverse Events (AEs) and Graded Laboratory Abnormalities|This outcome measure assessed the safety and tolerability profile of Stribild. Treatment-emergent adverse events (AEs) and graded laboratory abnormalities occurring from baseline up to 30 days following the last dose of study drug were summarized.|Up to 48 weeks plus 30 days|Safety Analysis Set||percentage of participants|||Number
683099|NCT01533259|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 12|The FDA-defined Snapshot algorithm was used, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time.|Week 12|Full Analysis Set: participants who received at least one dose of study drug and had no major protocol violations of study drug resistance at baseline.||percentage of participants||95% Confidence Interval|Number
683100|NCT01533246|Secondary|Progression Free Survival|Progression Free survival (PFS) time was measured as the time from the date of on study up to the date of occurrence of the first event defining a disease progression or death due to any cause, whichever occurred first.|assessed up to 2 years|Patients that received treatment||Months||Full Range|Median
683101|NCT01533246|Secondary|Overall Survival Based on the RECIST v1.1|The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started).|Up to 2 years|Patients that received treatment||Months||Full Range|Median
683102|NCT01533246|Secondary|Time to PSA Progression (TTPP) Analyzed Using the PCWG2 Definition|TTPP will be measured from protocol registration to appearance of PSA progression as defined by the criteria of the PSA Working Group response criteria. The end point for progression will be calculated at the time a 25% increase in PSA has been achieved.|assessed up to 12 weeks|Patients that received treatment.||months||95% Confidence Interval|Median
683103|NCT01533246|Secondary|Number of Patients With Bidimensional Measurable Disease RECIST-based Response|RECIST response categories: Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.|Up to 2 years|Patients with soft tissue disease only||participants|||Number
683104|NCT01533246|Secondary|Incidence of Toxicities Based on CTCAE Version 4.0 Criteria|Number of patients with at least possibly related to treatment toxicities grade 3 or higher based on Common Terminology Criteria for Adverse Events.|Up to 2 years|Patients that received treatment||participants|||Number
683105|NCT01533246|Primary|PSA Response Analyzed Using the PCWG2 Definition|Number of patients with a PSA Response will be evaluated according to the recommendations from National Cancer Institute Prostate-Cancer Working Group 2 (PCWG2) criteria. PSA decline of at least 50% from baseline confirmed by a second measurement at least 4 weeks later.|12 weeks|Patients that received treatment||participants|||Number
683106|NCT01533181|Other Pre-specified|Changes in Biomarker Expression|To be assessed by the Wilcoxon rank sum test.|Baseline to up to day 1 of course 3||||||
683107|NCT01533181|Secondary|Overall Survival (OS)|OS: Time from study enrollment to death from any cause. OS summarized similarly to PFS utilizing the K-M method.|Up to 2 years|All participants who received treatment||months||95% Confidence Interval|Median
683108|NCT01533181|Secondary|Incidence of Serious Adverse Events (SAEs) Possibly/Probably Definitely Related to Study Drugs|Participants with Grade 3 and 4 toxicities, possibly/probably/definitely related to study drugs. Number of Participants is per Event Category. Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.|1 year, 6 months|All participants who received treatment||participants|||Number
683109|NCT01533181|Secondary|Disease Control Rate (DCR)|DCR: Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) + Progressive Disease (PD). DCR summarized using both point estimates and exact confidence intervals based on the binomial distribution by arm.|Up to 2 years|All evaluable participants at time of analysis||participants|||Number
683110|NCT01533181|Primary|Median Progression Free Survival (PFS)|PFS: Time from randomization to time of disease progression or death. PFS summarized with the Kaplan-Meier (K-M) method by two arms (experimental versus control). Confidence intervals for the median PFS and PFS rates at different time points to be constructed when appropriate.|Up to 6 months|All participants who received treatment||months||95% Confidence Interval|Median
683111|NCT01533116|Primary|AUEC0-24 - Area Under the Effect-time Curve (AUEC) to 24 h Post-dose|AUEC0-24 - Area under the effect-time curve (AUEC) to 24 h post-dose.|pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid levodopa pharmacokinetic data. In this study, 48 subjects completed the entire study and 49 had valid levodopa data (one subject had valid levodopa data until Day 21)||pmol/mg Hb/h.h||Standard Deviation|Mean
683112|NCT01533116|Primary|tEmax - Time of Occurrence of Maximum Observed Effect on S-COMT Activity|tEmax - time of occurrence of maximum observed effect on S-COMT activity COMT - Catechol-O-Methyltransferase|pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid levodopa pharmacokinetic data. In this study, 48 subjects completed the entire study and 49 had valid levodopa data (one subject had valid levodopa data until Day 21)||hours||Standard Deviation|Mean
683113|NCT01533116|Primary|AUC0-t - Area Under the Plasma Concentration-time Curve to Last Measurable Time Point|AUC0-t - area under the plasma concentration-time curve from time 0 to last observed concentration 3-OMD - 3-O-methyl-dopa - metabolite of L-DOPA (levodopa) AUC0-t (Levodopa) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa® AUC0-t (3-OMD) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa® AUC0-t (BIA 9-1067) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa®|pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid levodopa pharmacokinetic data. In this study, 48 subjects completed the entire study and 49 had valid levodopa data (one subject had valid levodopa data until Day 21)||ng.h/mL||Standard Deviation|Mean
683114|NCT01533116|Primary|Tmax - Time to Maximum Plasma Concentration|Tmax - time to maximum plasma concentration Tmax (Levodopa) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa® Tmax (3-OMD) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa® Tmax (BIA 9-1067) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa®|pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid levodopa pharmacokinetic data. In this study, 48 subjects completed the entire study and 49 had valid levodopa data (one subject had valid levodopa data until Day 21)||hours||Full Range|Median
683115|NCT01533116|Primary|Cmax - Maximum Plasma Concentration|Cmax - maximum plasma concentration Cmax (Levodopa) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa® Cmax (3-OMD) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa® Cmax (BIA 9-1067) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa®|pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid levodopa pharmacokinetic data. In this study, 48 subjects completed the entire study and 49 had valid levodopa data (one subject had valid levodopa data until Day 21)||ng/mL||Standard Deviation|Mean
683116|NCT01533077|Primary|AUC0-∞ - Area Under the Plasma Concentration-time Curve Extrapolated to Infinity (BIA 9-1067)|Mean pharmacokinetic parameters of BIA 9-1067|Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose.|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods. In this study, 18 subjects completed 2 treatment periods, 17 subjects completed 3 treatment periods and 16 subjects completed all 4 treatment periods.||ng.h/mL||Standard Deviation|Mean
683117|NCT01533077|Primary|AUC0-t - Area Under the Plasma Concentration-time Curve to Last Measurable Time Point (BIA 9-1067)|Mean pharmacokinetic parameters of BIA 9-1067|Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose.|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods. In this study, 18 subjects completed 2 treatment periods, 17 subjects completed 3 treatment periods and 16 subjects completed all 4 treatment periods.||ng.h/mL||Standard Deviation|Mean
683118|NCT01533077|Primary|Tmax - Time to Occurrence of Cmax (BIA 9-1067)|Pharmacokinetic parameters of BIA 9-1067. For tmax = time to Cmax values are presented as median with range values.|Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose.|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods. In this study, 18 subjects completed 2 treatment periods, 17 subjects completed 3 treatment periods and 16 subjects completed all 4 treatment periods.||hours||Full Range|Median
683119|NCT01533077|Primary|Cmax - Maximum Observed Plasma Concentration (BIA 9-1067)|Mean pharmacokinetic parameters of BIA 9-1067|Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose.|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods. In this study, 18 subjects completed 2 treatment periods, 17 subjects completed 3 treatment periods and 16 subjects completed all 4 treatment periods.||ng/mL||Standard Deviation|Mean
683155|NCT01532869|Secondary|Mean Serum Concentrations of Interleukin (IL)-6 by Visit|Observed data was presented for this outcome measure.|Baseline, Weeks 1, 2, 3, 8, 16, 24, and 48|Safety population. Here, number of participants analyzed included only those participants who were evaluable for this outcome measure and “n” included those who were evaluable for the specific item at specified time point in specified time frame.||picograms per milliliters (pg/mL)||Standard Deviation|Mean
683120|NCT01533077|Primary|AUC0-∞ - Area Under the Plasma Concentration-time Curve Extrapolated to Infinity (Carbidopa)|Pharmacokinetic parameters of carbidopa. For tmax = time to Cmax values are presented as median with range values.|Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods. In this study, 18 subjects completed 2 treatment periods, 17 subjects completed 3 treatment periods and 16 subjects completed all 4 treatment periods.||ng.h/mL||Standard Deviation|Mean
683121|NCT01533077|Primary|AUC0-t - Area Under the Plasma Concentration-time Curve to Last Measurable Time Point (Carbidopa)|Mean pharmacokinetic parameters of carbidopa|Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose.|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods. In this study, 18 subjects completed 2 treatment periods, 17 subjects completed 3 treatment periods and 16 subjects completed all 4 treatment periods.||ng.h/mL||Standard Deviation|Mean
683122|NCT01533077|Primary|Tmax - Time to Occurrence of Cmax (Carbidopa)|Pharmacokinetic parameters of carbidopa. For tmax = time to Cmax values are presented as median with range values.|Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose.|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods. In this study, 18 subjects completed 2 treatment periods, 17 subjects completed 3 treatment periods and 16 subjects completed all 4 treatment periods.||hours||Full Range|Median
683123|NCT01533077|Primary|Cmax - Maximum Observed Plasma Concentration (Carbidopa)|Mean pharmacokinetic parameters of carbidopa|Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose.|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods. In this study, 18 subjects completed 2 treatment periods, 17 subjects completed 3 treatment periods and 16 subjects completed all 4 treatment periods.||ng/mL||Standard Deviation|Mean
683124|NCT01533077|Primary|AUC0-∞ - Area Under the Plasma Concentration-time Curve Extrapolated to Infinity (3-OMD)|Mean pharmacokinetic parameters of 3-O-methyl-levodopa (3-OMD)|Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose.|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods. In this study, 18 subjects completed 2 treatment periods, 17 subjects completed 3 treatment periods and 16 subjects completed all 4 treatment periods.||ng.h/mL||Standard Deviation|Mean
683125|NCT01533077|Primary|AUC0-t - Area Under the Plasma Concentration-time Curve to Last Measurable Time Point (3-OMD)|Mean pharmacokinetic parameters of 3-O-methyl-levodopa (3-OMD)|Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose.|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods. In this study, 18 subjects completed 2 treatment periods, 17 subjects completed 3 treatment periods and 16 subjects completed all 4 treatment periods.||ng.h/mL||Standard Deviation|Mean
683126|NCT01533077|Primary|Tmax - Time to Occurrence of Cmax (3-OMD)|Pharmacokinetic parameters of 3-O-methyl-levodopa (3-OMD). For tmax = time to Cmax values are presented as median with range values.|Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods. In this study, 18 subjects completed 2 treatment periods, 17 subjects completed 3 treatment periods and 16 subjects completed all 4 treatment periods.||hours||Full Range|Median
683127|NCT01533077|Primary|Cmax - Maximum Observed Plasma Concentration (3-OMD)|Mean pharmacokinetic parameters of 3-O-methyl-levodopa (3-OMD)|Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods. In this study, 18 subjects completed 2 treatment periods, 17 subjects completed 3 treatment periods and 16 subjects completed all 4 treatment periods.||ng/mL||Standard Deviation|Mean
683128|NCT01533077|Primary|AUC0-∞ - Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (L-DOPA)|Mean pharmacokinetic parameters of L-beta-3,4-dihydroxyphenylalanine (levodopa) (L-DOPA)|pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose.|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods. In this study, 18 subjects completed 2 treatment periods, 17 subjects completed 3 treatment periods and 16 subjects completed all 4 treatment periods.||ng.h/mL||Standard Deviation|Mean
683129|NCT01533077|Primary|AUC0-t - Area Under the Plasma Concentration-time Curve to Last Measurable Time Point (L-DOPA)|Mean pharmacokinetic parameters of L-beta-3,4-dihydroxyphenylalanine (levodopa) (L-DOPA)|pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose.|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods. In this study, 18 subjects completed 2 treatment periods, 17 subjects completed 3 treatment periods and 16 subjects completed all 4 treatment periods.||ng.h/mL||Standard Deviation|Mean
683130|NCT01533077|Primary|Tmax - Time of Occurrence of Cmax Maximum Observed Plasma Concentration (L-DOPA)|Pharmacokinetic parameters of L-beta-3,4-dihydroxyphenylalanine (levodopa) (L-DOPA). For tmax = time to Cmax values are presented as median with range values.|pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose.|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods. In this study, 18 subjects completed 2 treatment periods, 17 subjects completed 3 treatment periods and 16 subjects completed all 4 treatment periods.||hours||Full Range|Median
683131|NCT01533077|Primary|Cmax - Maximum Observed Plasma Concentration (L-DOPA)|Mean pharmacokinetic parameters of L-beta-3,4-dihydroxyphenylalanine (levodopa) (L-DOPA)|pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose.|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods. In this study, 18 subjects completed 2 treatment periods, 17 subjects completed 3 treatment periods and 16 subjects completed all 4 treatment periods.||ng/mL||Standard Deviation|Mean
683183|NCT01532570|Secondary|Concentration of Inflammatory Biomarker (CRP) of Vascular BD|The time of final evaluation : Final time point for the 5 mg/kg patients, final time point during administration of 5 mg/kg for the 10 mg/kg patients, final time point during administration of 5 mg/kg for patients who discontinued the study.|Week 0, 2, 6, 10, then every 4 weeks after Week 14 to Week 54|||mg/dL||Inter-Quartile Range|Median
683132|NCT01533038|Primary|Responder Analysis: A Subject is a Responder at the 12 Month Follow-up Time Point if All 6 Thresholds of the BPH-6 Endpoint Are Met|"LUTS: ≥ 30% reduction in IPSS compared to baseline
Recovery Experience: Return to pre-operative activity levels by 1 month
Erectile function: Less than 6-point reduction in SHIM compared to baseline.
Ejaculatory function: Response on MSHQ-EjD that indicates emission of semen. This excludes the response Could not ejaculate
Continence: ISI score of 4 points or less at all follow-up time points
Safety: No procedure-related adverse event greater than Grade I on the Clavien-Dindo classification system modified for TURP at any time during procedure or follow up."|Month 12|||% Responders of Participants|||Number
683133|NCT01532999|Secondary|PTSD Remission|Total CAPS score of less than or equal to 45 at week 9 (single observation point)|Week 9|All participants who were randomized and attended at least one intervention session.||percentage of participants|||Number
683134|NCT01532999|Secondary|PTSD Response|Greater than or equal to 30% improvement on PTSD CAPS scale|Baseline to week 9|All participants who were randomized and attended at least one intervention session.||percentage of participants|||Number
683135|NCT01532999|Secondary|Change From Baseline in CAPS D Subscale|Clinician Administered PTSD Scale (CAPS) D subscale measures the hyperarousal cluster (i.e. D criterion) of PTSD symptoms and includes the items 13 - 17 of the CAPS, which is a clinician-administered assessment of posttraumatic stress disorder (PTSD) symptoms. Frequency and intensity scores for each item is summed for a range of 0 to 40 (higher score = more severe PTSD).|Baseline to week 9|All participants who were randomized and attended at least one intervention session.||units on a scale||Standard Deviation|Mean
683136|NCT01532999|Secondary|Change From Baseline in CAPS C Subscale|Clinician Administered PTSD Scale (CAPS) C subscale measures the avoidance and emotional numbing cluster (i.e. C criterion) of PTSD symptoms and includes the items 6 - 12 items of the CAPS, which is a clinician-administered assessment of posttraumatic stress disorder (PTSD) symptoms. Frequency and intensity scores for each item is summed for a range of 0 to 56 (higher score = more severe PTSD).|Baseline to week 9|All participants who were randomized and attended at least one intervention session.||units on a scale||Standard Deviation|Mean
683137|NCT01532999|Secondary|Change From Baseline in CAPS B Subscale|Clinician Administered PTSD Scale (CAPS) B subscale measures the re-experiencing cluster (i.e. B criterion) of PTSD symptoms and includes the first 5 items of the CAPS, which is a clinician-administered assessment of posttraumatic stress disorder (PTSD) symptoms. Frequency and intensity scores for each item is summed for a range of 0 to 40 (higher score = more severe PTSD).|Baseline to week 9|All participants who were randomized and attended at least one intervention session.||units on a scale||Standard Deviation|Mean
683138|NCT01532999|Secondary|Change From Baseline in Patient Health Questionnaire (PHQ-9)|Patient Health Questionnaire (PHQ-9) is a brief 9-item measure of depressive symptoms that has established reliability and validity in community and clinical populations. All items are summed for total score ranging from 0 to 27 (higher score = more severe depression).|Baseline to week 9|All participants who were randomized and attended at least one intervention session.||units on a scale||Standard Deviation|Mean
683139|NCT01532999|Secondary|Change From Baseline in Five Facet Mindfulness Questionnaire (FFMQ)|"Five Facet Mindfulness Questionnaire (FFMQ) is used to evaluate the effects of MBSR vs. PCGT on mindfulness (S1). The FFMQ is a 39-item self-report instrument that assesses the general tendency to be mindful in daily life through 5 facets: observing, describing, acting with awareness, non-judging of inner experience, non-reactivity to inner experience. Increases in FFMQ mediate improvements in well being in observational studies of MBSR. Each item is rated 1 to 5 (never or very rarely true to very often or always true). Some of the items are reverse scored (R). Scoring Information: Observe items:1, 6, 11, 15, 20, 26, 31, 36; Describe items: 2, 7, 12R, 16R, 22R, 27, 32, 37; Act with Awareness items: 5R, 8R, 13R, 18R, 23R, 28R, 34R, 38R; Nonjudge items: 3R, 10R, 14R, 17R, 25R, 30R, 35R, 39R; Nonreact items: 4, 9, 19, 21, 24, 29, 33. Total all subscales for score (higher score = greater degree of mindfulness). Score range 39-195 with higher=more mindfulness."|Baseline to week 9|All participants who were randomized and attended at least one intervention session.||units on a scale||Standard Deviation|Mean
683140|NCT01532999|Secondary|Change From Baseline in PTSD Checklist (PCL)|"PTSD Checklist (PCL) is a 17-item self-report scale intended to measure PTSD symptom severity. The PCL has demonstrated excellent internal consistency (alpha = .94-.97), and test-retest reliability over 2 to 3 days was .96 for Vietnam veterans. Respondents rate each item from 1 (not at all) to 5 (extremely) to indicate the degree to which they have been bothered by that particular symptom over the past month. Thus, total possible scores (items summed) range from 17 to 85 (higher score is more severe). A cut-off score of 50 indicates a probable diagnosis of PTSD."|Baseline to week 9|All participants who were randomized and attended at least one intervention session.||units on a scale||Standard Deviation|Mean
683141|NCT01532999|Primary|Change From Baseline in Clinician Administered PTSD Scale|Clinician Administered PTSD Scale (CAPS) is a 17-item standard rating scale that measures PTSD severity with scores ranging from 0-136 (higher score = more severe). Scores of frequency and intensity are summed for the 17-items to yield the total CAPS score.|Baseline to week 9|All participants who were randomized and attended at least one intervention session.||units on a scale||Standard Deviation|Mean
683142|NCT01532973|Primary|Number of Participants Who Had Study Drug Discontinued Due to an Adverse Event|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. Participants who had study drug discontinued due to an AE were recorded.|Up to 5 days|All participants who received at least 1 dose of study drug. Event summarized by drug taken at time of event and not by panel or genotype||Participants|||Number
683143|NCT01532973|Primary|Number of Participants Experiencing an Adverse Event (AE) - Day 1 to Day 5|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE.|Up to 5 days|All participants who received at least 1 dose of study drug. Events reported by drug taken at time of event and not by panel or genotype||Participants|||Number
683144|NCT01532973|Primary|Mean Maximum Reduction in Log10 HCV Viral Load - HCV GT1a|HCV RNA levels were assessed at baseline (predose Day 1) and 24 hours postdose on Days 1-5. using the Roche TaqMan HCV 2.0 assay and transformed to Log10 values. The lower limits of quantification (LLOQ) and detection (LLD) were 25 and 9.3 IU/mL, respectively. The change in log10 LS mean HCV RNA levels was calculated for each timepoint and the maximum change from baseline was recorded.|Up to 5 days|All participants who complied with the protocol sufficiently to ensure that data would likely exhibit the effects of treatment, according to the underlying scientific model and had available data from at least 1 treatment. Data for placebo were grouped together regardless of genotype or randomly assigned panel.||IU/mL||95% Confidence Interval|Least Squares Mean
683145|NCT01532973|Primary|Mean Maximum Reduction in Log10 HCV Viral Load - HCV GT3|HCV RNA levels were assessed at baseline (predose Day 1) and 24 hours postdose on Days 1-5. using the Roche TaqMan HCV 2.0 assay and transformed to Log10 values. The lower limits of quantification (LLOQ) and detection (LLD) were 25 and 9.3 IU/mL, respectively. The change in log10 LS mean HCV RNA levels was calculated for each timepoint and the maximum change from baseline was recorded.|Up to 5 days|All participants who complied with the protocol sufficiently to ensure that data would likely exhibit the effects of treatment, according to the underlying scientific model and had available data from at least 1 treatment. Data for placebo were grouped together regardless of genotype or randomly assigned panel. Panel H was not conducted.||IU/mL||95% Confidence Interval|Least Squares Mean
683146|NCT01532973|Primary|Mean Maximum Reduction in Log10 HCV Viral Load - HCV GT1|HCV RNA levels were assessed at baseline (predose Day 1) and 24 hours postdose on Days 1-5. using the Roche TaqMan HCV 2.0 assay and transformed to Log10 values. The lower limits of quantification (LLOQ) and detection (LLD) were 25 and 9.3 IU/mL, respectively. The change in log10 LS mean HCV RNA levels was calculated for each timepoint and the maximum change from baseline was recorded.|Up to 5 days|All participants who complied with the protocol sufficiently to ensure that data would likely exhibit the effects of treatment, according to the underlying scientific model and had available data from at least 1 treatment. Data for placebo were grouped together regardless of genotype or randomly assigned panel. Panel D was not conducted.||IU/mL||95% Confidence Interval|Least Squares Mean
683147|NCT01532973|Primary|Mean Reduction From Baseline in Log10 Plasma HCV RNA at Day 5 - HCV GT1a|HCV RNA levels were assessed at baseline (predose on Day 1) and 24 hours postdose on Day 5 using the Roche TaqMan HCV 2.0 assay and transformed to Log10 values. The lower limits of quantification (LLOQ) and detection (LLD) were 25 and 9.3 IU/mL, respectively. Least squares means and confidence intervals obtained from the linear mixed model with log10 HCV RNA reduction as response and a fixed effect for treatment, time and treatment by time interaction.|Baseline (Predose on Day 1) and 24-hour post-dose on Day 5|All participants who complied with the protocol sufficiently to ensure that data would likely exhibit the effects of treatment, according to the underlying scientific model and had available data from at least 1 treatment. Data for placebo were grouped together regardless of genotype or randomly assigned panel.||IU/mL||95% Confidence Interval|Least Squares Mean
683148|NCT01532973|Primary|Mean Reduction From Baseline in Log10 Plasma HCV RNA at Day 5 - HCV GT3|HCV RNA levels were assessed at baseline (predose on Day 1) and 24 hours postdose on Day 5 using the Roche TaqMan HCV 2.0 assay and transformed to Log10 values. The lower limits of quantification (LLOQ) and detection (LLD) were 25 and 9.3 IU/mL, respectively. Least squares means and confidence intervals obtained from the linear mixed model with log10 HCV RNA reduction as response and a fixed effect for treatment, time and treatment by time interaction|Baseline (Predose on Day 1) and 24-hour post-dose on Day 5|All participants who complied with the protocol sufficiently to ensure that data would likely exhibit the effects of treatment, according to the underlying scientific model and had available data from at least 1 treatment. Data for placebo were grouped together regardless of genotype or randomly assigned panel. Panel H was not conducted.||IU/mL||95% Confidence Interval|Least Squares Mean
683149|NCT01532973|Primary|Mean Reduction From Baseline in Log10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Day 5 - HCV GT1|HCV RNA levels were assessed at baseline (predose on Day 1) and 24 hours postdose on Day 5 using the Roche TaqMan HCV 2.0 assay and transformed to Log10 values. The lower limits of quantification (LLOQ) and detection (LLD) were 25 and 9.3 IU/mL, respectively. Least squares means and confidence intervals obtained from the linear mixed model with log10 HCV RNA reduction as response and a fixed effect for treatment, time and treatment by time interaction.|Baseline (Predose on Day 1) and 24-hour post-dose on Day 5|All participants who complied with the protocol sufficiently to ensure that data would likely exhibit the effects of treatment, according to the underlying scientific model and had available data from at least 1 treatment. Data for placebo were grouped together regardless of genotype or randomly assigned panel. Panel D was not conducted.||IU/mL||95% Confidence Interval|Least Squares Mean
683150|NCT01532934|Secondary|New Criminal Charge|New criminal charge vs. no new criminal charge at follow-up as indicated by county database.|one year|||participants|||Number
683151|NCT01532934|Secondary|Shortened Inventory of Problems With Alcohol and Drugs (SIP-AD)|A measure of consequences of drug and alcohol use across several domains (e.g., social, work, health), SIP-AD scores range from 0-45, with higher scores indicating higher levels of substance use consequences.|six months|||units on a scale||Standard Deviation|Mean
683152|NCT01532934|Primary|Percent Days Abstinent Per Month From Drug Use|Using timeline followback data, frequency of substance use was assessed for months three through six and presented as average percent days abstinent per month.|three to six months post baseline|105 adults (68 men and 37 women) were recruited in an urban pretrial jail diversion program. 78 (74.3%) were retained through six months. Of these, 73 were out of controlled environments (e.g., jail, inpatient treatment) for long enough to have their substance use data analyzed.||percentage of days abstinent||Standard Deviation|Mean
683153|NCT01532869|Secondary|Percentage of Participants With Anti-Tocilizumab Antibody||Baseline, and post-baseline (up to Week 48)|Safety population. Here, number of participants analyzed included only those participants who were evaluable for this outcome measure.||percentage of participants|||Number
683154|NCT01532869|Secondary|Mean Serum Concentrations of Soluble IL-6 Receptor (R) by Visit|Observed data was presented for this outcome measure.|Baseline, Weeks 1, 2, 3, 8, 16, 24, and 48|Safety population. Here, number of participants analyzed included only those participants who were evaluable for this outcome measure and “n” included those who were evaluable for the specific item at specified time point in specified time frame.||pg/mL||Standard Deviation|Mean
683156|NCT01532869|Secondary|Area Under the Concentration-Time Curve (AUC) From Time 0 to 168 Hour (AUC0-168)|AUC was a measure of the serum concentration of the drug over time which was measured in micrograms times (*) hour per milliliters (µg*hr/mL). It is used to characterize drug absorption.|Pre-dose, 24, 48, 72, 96, 120 or 144, and 168 hours post dose for Baseline and Week 16|Pharmacokinetic (PK) population included all participants who received at least one TCZ injection and had at least one PK sample with detectable results. Here, “n” = participants evaluable for the specific item at specified time point in specified time frame.||µg*hr/mL||Standard Deviation|Mean
683157|NCT01532869|Secondary|Change From Baseline in Tender Joint Count 28 (TJC28)|Joint tenderness was evaluated as per assessment of 28 joints. Joints on both sides of the body, including shoulders, elbows, wrists, 10 metacarpal phalangeal (MCP) joints, 10 proximal interphalangeal joint (PIP) joints, and both knees, were assessed. Joints were classified as not tender = 0 or tender = 1. Observed data was presented for this outcome measure.|Baseline, Weeks 3, 8, 16, 24, 32, 40, and 48|ITT population. Here, “n” = participants evaluable for the specific item at specified time point in specified time frame.||joint count||Standard Deviation|Mean
683158|NCT01532869|Secondary|Percentage of Participants Who Maintained or Improved in mRSS From Week 24 to Week 48|Skin thickness was assessed by the mRSS. The mRSS was rated with scores ranging from 0 (normal) to 3 (severe skin thickening) across 17 different sites. The total score was the sum of the individual skin scores in the 17 body areas (e.g., face, hands, fingers; proximal area of the arms, distal area of the arms, thorax, abdomen; proximal area of the legs, and distal area of the legs, feet), giving a range of 0–51 units and had been validated for participants with systemic sclerosis (SSc). A negative change from baseline showed improvement. Percentage of participants with an improvement in mRSS at Week 24 (change from baseline <0) that maintained or further improved at Week 48 were reported as “Yes” and “No” with Yes = improvers at week 24 that had a change from baseline in mRSS at Week 48 <= change from baseline at Week 24.|Week 48|ITT population. Here number of participants analyzed included those with mRSS change from baseline <0 at Week 24 and with non-missing change from baseline in mRSS at Week 48.||percentage of participants|||Number
683159|NCT01532869|Secondary|Change From Baseline in mRSS at Week 48|Skin thickness was assessed by the mRSS. The mRSS was rated with scores ranging from 0 (normal) to 3 (severe skin thickening) across 17 different sites. The total score was the sum of the individual skin scores in the 17 body areas (e.g., face, hands, fingers; proximal area of the arms, distal area of the arms, thorax, abdomen; proximal area of the legs, and distal area of the legs, feet), giving a range of 0–51 units and had been validated for participants with systemic sclerosis (SSc). A negative change from baseline showed improvement.|Baseline, Week 48|ITT population. Here, number of participants analyzed included only those participants who were evaluable for this outcome measure at specified time point up to 48 weeks.||unit on a scale||95% Confidence Interval|Least Squares Mean
683160|NCT01532869|Secondary|Change From Baseline in 5-D Itch Scale at Week 24 and Week 48|The 5-D Itch Scale contained five domains of duration, degree, direction, disability, and distribution. The endpoint of the scale was pruritus. Each domain was scored on a 5-point scale, the scores of each of the five domains were achieved separately and then summed together to obtain a total 5-D score. 5-D scores ranged between 5 (no pruritus) and 25 (most severe pruritus).|Baseline, Weeks 24 and 48|ITT population. Here, number of participants analyzed included only those participants who were evaluable for this outcome measure and “n” included those who were evaluable for the specific item at specified time point in specified time frame.||units on a scale||95% Confidence Interval|Least Squares Mean
683161|NCT01532869|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy−Fatigue (FACIT-Fatigue) Score at Week 24 and Week 48|This FACIT-Fatigue Scale was a 13-item measure with participants scoring each item on a 5-point scale (0 to 4) up to 52 points. The endpoint measured was fatigue. On this scale, a numerical increase indicated an improvement in the participant’s condition.|Baseline, Weeks 24 and 48|ITT population. Here, number of participants analyzed included only those participants who were evaluable for this outcome measure and “n” included those who were evaluable for the specific item at specified time point in specified time frame.||units on a scale||95% Confidence Interval|Least Squares Mean
683162|NCT01532869|Secondary|Change From Baseline in Patient’s Global Assessment at Week 24 and Week 48|The Patient’s Global Assessment was a patient's reported outcome that represented the participant’s overall assessment of his or her current SSc on a 100 mm horizontal VAS scale (0 mm to 100 mm), with higher scores indicating worsening disease.|Baseline, Weeks 24 and 48|ITT population. Here, number of participants analyzed included only those participants who were evaluable for this outcome measure and “n” included those who were evaluable for the specific item at specified time point in specified time frame.||mm||95% Confidence Interval|Least Squares Mean
683163|NCT01532869|Secondary|Change From Baseline in Clinician’s Global Assessment at Week 24 and Week 48|The Clinician’s Global Assessment evaluated the overall impact of SSc on the participant as assessed by the physician on a VAS with scores ranging from 0 to 100 mm, with higher scores indicating worse disease in terms of severity, damage, or overall disease, but there was no standardization for the scale.|Baseline, Weeks 24 and 48|ITT population. Here, number of participants analyzed included only those participants who were evaluable for this outcome measure and “n” included those who were evaluable for the specific item at specified time point in specified time frame.||mm||95% Confidence Interval|Least Squares Mean
683164|NCT01532869|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24 and Week 48|The HAQ-DI scale consisted of 20 questions referring to eight component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. The total score indicated the participant’s self-assessed level of disability. There are four possible responses for each component: 0 = without any difficulty; 1 = with some difficulty; 2 = with much difficulty; 3 = unable to do. The HAQ-DI was the sum of the domain scores, divided by the number of domains that have a score (i.e. the average score), with total range of 0 to 3, higher scores showing larger functional limitation.|Baseline, Weeks 24 and 48|ITT population. Here, number of participants analyzed included only those participants who were evaluable for this outcome measure and “n” included those who were evaluable for the specific item at specified time point in specified time frame.||units on a scale||95% Confidence Interval|Least Squares Mean
683165|NCT01532869|Secondary|Change From Baseline in Physical Function Assessed by Scleroderma Health Assessment Questionnaire Disability Index (SHAQ-DI)|SHAQ-DI assessed five scleroderma-specific visual analogue scale (VAS) items to explore the impact of participant’s disease. These items were developed to measure the effect of scleroderma on five elements of disease that could have a great impact on a participant’s daily activities. Each VAS item was rated separately (0−100 millimeters [mm]), with higher scores indicating more severe disease. The five items were: 1) intestinal disease, 2) breathing problem, 3) Raynaud syndrome, 4) finger ulcers, and 5) overall disease.|Baseline, Weeks 24 and 48|ITT population. Here, number of participants analyzed included only those participants who were evaluable for this outcome measure and “n” included those who were evaluable for the specific item at specified time point in specified timeframe.||mm||95% Confidence Interval|Least Squares Mean
683166|NCT01532869|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Week 8 after last dose that were absent before treatment or that worsened relative to pretreatment state.|Week 48|Safety population.||percentage of participants|||Number
683167|NCT01532869|Primary|Change From Baseline in Modified Rodnan Skin Score (mRSS) at Week 24|Skin thickness was assessed by the mRSS. The mRSS was rated with scores ranging from 0 (normal) to 3 (severe skin thickening) across 17 different sites. The total score was the sum of the individual skin scores in the 17 body areas (e.g., face, hands, fingers; proximal area of the arms, distal area of the arms, thorax, abdomen; proximal area of the legs, and distal area of the legs, feet), giving a range of 0–51 units and had been validated for participants with systemic sclerosis (SSc). A negative change from baseline showed improvement.|Baseline, Week 24|Intent-to-treat (ITT) population included all participants randomized who had received any study drug at the time of the Week 24 cutoff date (14 January 2014). Here, number of participants analyzed included only those participants who were evaluable for this outcome measure at any time point up to Week 24.||unit on a scale||95% Confidence Interval|Least Squares Mean
683168|NCT01532635|Secondary|Assessment for Tumor Escape Mechanisms|To test for loss of one or both HLA haplotypes in patients who relapse post-transplant and examine the relapse in the context of the characteristics of the 2 donors|1 year post transplant||||||
683169|NCT01532635|Secondary|Tolerance of DLI|Assessment of the tolerance of the period of fever, diarrhea, and rash after the introduction of second donor and qualitatively compare it to prior patient groups or concurrent patient groups|2-6 days prior to transplant||||||
683170|NCT01532635|Secondary|Non-relapse Morbidity and Mortality|Assessment of regimen related toxicity, GVHD incidence and severity, and overall survival.|1 year||||||
683171|NCT01532635|Secondary|Immune Reconstitution|Assess T and B cell Reconstitution|1 year||||||
683172|NCT01532635|Secondary|Engraftment|To assess the consistency and pace of engraftment of both donors.|1 year||||||
683173|NCT01532635|Secondary|Relapse Rates|To assess if establishment of a dominant donor versus persistent chimerism of both donors is associated with a lower relapse rate.|1 year||||||
683174|NCT01532635|Secondary|Assessment of Dominance|If dominance is observed, to compare the 2 donors with regard to degree of HLA mismatch, KIR types, CD 34+ cell doses, infusion order, donor age, and donor alloreactivity points in an effort to identify potential biologic factors that predict for dominance. To determine if trends toward dominance occur in T cell, NK cell, or other cellular subsets prior to emerging in the graft as a whole.|1 year||||||
683175|NCT01532635|Secondary|Chimerism Assessment|To assess chimerism to ascertain whether one donor is emerging as dominant at regular intervals beginning at the time of engraftment.|1 year||||||
683176|NCT01532635|Primary|One Year Relapse-Free Survival|"To assess one year relapse-free survival (RFS) in patients undergoing HSCT (hematopoietic stem cell transplantation) using the TJU 2 step-approach with two donors.
Survival will be estimated by the Kaplan-Meier method. All estimates of rates will be presented with corresponding confidence intervals. For 1 year RFS rates, the method of Atkinson and Brown will be used to allow for the two-stage design; otherwise the method of Conover."|1 year||||||
683177|NCT01532570|Secondary|Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients|"The investigator assessed the clinical symptoms associated with vascular-BD at each time point of the evaluation in compared to Week 0, in accordance with the categories as No symptom, Improved, Unchanged or Worsened."|Week 2, 6, 10, then every 4 weeks after Week 14 to Week 54|||participants|||Number
683178|NCT01532570|Secondary|Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients|"The investigator assessed the clinical symptoms associated with neuro-BD at each time point of the evaluation in compared to Week 0, in accordance with the categories as No symptom, Improved, Unchanged or Worsened."|Week 2, 6, 10, then every 4 weeks after Week 14 to Week 54|||participants|||Number
683179|NCT01532570|Secondary|The Number of Improved Intestinal BD Patients From Baseline|"The investigator assessed clinical symptoms associated with intestinal BD in one week before the day of evaluation as  No symptom, Very slightly poor, Slightly poor, Poor or Extremely poor.
We calculated improved patients in comparison with those for Week 0."|Week 0, 2, 6, 10, then every 4 weeks after Week 14 to Week 54|||participants|||Number
683180|NCT01532570|Secondary|Interleukin-6 (IL-6) Concentration in CSF for Neuro-BD||Week 0, Week 14, Week 30, Week 54|||pg/mL|||Number
683181|NCT01532570|Secondary|Cell Counts in Cerebrospinal Fluid (CSF) for Acute Neuro-BD|The time of final evaluation : Final time point for the 5 mg/kg patients, final time point during administration of 5 mg/kg for the 10 mg/kg patients, final time point during administration of 5 mg/kg for patients who discontinued the study.|Week 0, Week 14, Week 30, Week 54|||cells/mL|||Number
683182|NCT01532570|Secondary|Level of Inflammatory Biomarker (Erythrocyte Sedimentation Rate) of Vascular BD|The time of final evaluation : Final time point for the 5 mg/kg patients, final time point during administration of 5 mg/kg for the 10 mg/kg patients, final time point during administration of 5 mg/kg for patients who discontinued the study.|Week 0, 2, 6, 10, then every 4 weeks after Week 14 to Week 54|||mm/hr||Inter-Quartile Range|Median
683184|NCT01532570|Secondary|Concentration of Inflammatory Biomarker (C-reactive Protein (CRP)) of Intestinal BD|The time of final evaluation : Final time point for the 5 mg/kg patients, final time point during administration of 5 mg/kg for the 10 mg/kg patients, final time point during administration of 5 mg/kg for patients who discontinued the study.|Week 0, 2, 6, 10, then every 4 weeks after Week 14 to Week 54|||mg/dL||Inter-Quartile Range|Median
683185|NCT01532570|Secondary|Imaging Findings: CT, PET/CT for Vascular-BD|"Changes in CT or PET/CT findings were scored at day of evaluation, in accordance with the following categories, Improves, Unchanged or Worsened by comparison with those at Week 0."|Week 14, Week 30, Week 54|||participants|||Number
683186|NCT01532570|Secondary|Imaging Findings: Brainstem MRI for Chronic Neuro-BD|"Changes in brainstem MRI findings were scored at day of evaluation, in accordance with the following categories, Unchanged or Reduced in the brainstem area compared to Week 0."|Week 14, Week 30, Week 54|||participants|||Number
683187|NCT01532570|Secondary|Imaging Findings: Brain Magnetic Resonance Imaging (MRI) for Acute Neuro-BD|"Changes in brain MRI findings were scored at day of evaluation, in accordance with the following categories, No high-intensity areas, Reduction or No changes/increase in the size of high-intensity areas compared to Week 0."|Week 14, Week 30, Week 54|||participants|||Number
683188|NCT01532570|Secondary|Imaging Findings:Endoscopic Examination for Intestinal BD|"The investigator assessed the length of the major axis of the principal intestinal ulcer at day of evaluation and scored in accordance with the following categories, Healed/scarred, Reduced to =< 25%, Reduced to > 25% to =< 50% or Reduced to > 50%/no change/increased in the principal intestinal ulcer compared to size at Week 0."|Week 14, Week 30, Week 54|||participants|||Number
683189|NCT01532570|Secondary|Patient General Visual Analogue Scale (VAS) for the Clinical Symptoms Associated With Each BD|"The VAS evaluation measured using the General VAS evaluation From and the range is from 0 to 100 mm. The best condition per one week before evaluation visit for the clinical symptoms associated with each BD is defined as 0 and the worst condition is defined as 100.
The time of final evaluation : Final time point for the 5 mg/kg patients, final time point during administration of 5 mg/kg for the 10 mg/kg patients, final time point during administration of 5 mg/kg for patients who discontinued the study."|Week 0, 2, 6, 10, then every 4 weeks after Week 14 to Week 54|||units on a scale||Standard Deviation|Mean
683190|NCT01532570|Secondary|Percentage of Participants With Complete Response at Week 14 and 54|"We defined the patient who met the following criteria as the complete responders.
The criteria of complete responders are that clinical symptoms associated with each BD have disappeared and morphological characteristics (ex. ulcers area, CT or PET/CT findings etc) at the lesion site and inflammatory markers (ex. cerebrospinal fluid and serum inflammatory markers) are improved compared to Week 0."|Week 14, Week 54|||percentage of Complete Responders|||Number
683191|NCT01532570|Primary|Percentage of Participants With Complete Response at Week 30|"We defined the patient who met the following criteria as the complete responders.
The criteria of complete responders are that clinical symptoms associated with each BD have disappeared and morphological characteristics (ex. ulcers area, Computed tomography (CT) or Positron emission tomography/Computed tomography (PET/CT) findings etc) at the lesion site and inflammatory markers (ex. cerebrospinal fluid and serum inflammatory markers) are improved compared to Week 0."|Week 30|||percentage of Complete Responders|||Number
683192|NCT01532453|Secondary|Number of Patients With New Actinic Keratoses, Squamous Cell Carcinomas or Basal Cell Carcinomas||2 Years|"The Full analysis set (FAS) comprised 220 patients: 146 in the MD 3511356 group and 74 in the standard care group.
For patient 10018 (MD-3511356 group) the age of first organ transplant was not computable due to missing date."||percentage of patients|||Number
683193|NCT01532453|Primary|Number of New Clinically Diagnosed Actinic Keratoses or Squamous Cell Carcinomas||2 Years|241 patients were randomized: 160 to the MD 3511356 group and 81 to the standard care group. All 241 randomized patients received at least one dose of trial device and therefore were all included in the safety population. The Full analysis set (FAS) comprised 220 patients: 146 in the MD 3511356 group and 74 in the standard care group.||new actinic keratoses or scc||Standard Deviation|Mean
683194|NCT01532414|Primary|Subjects With 50% or Greater Decrease in Sperm Concentration Comparison of Proportion of Subjects With 50% or Greater Decrease in Sperm|"Proportion of subjects with a 50% or greater decrease in sperm concentration from baseline after 12 weeks of treatment in Androxal treated subjects to placebo.
The difference between the proportions (placebo minus Androxal) and corresponding 95% confidence interval was determined and compared to the equivalence limit of -20%. If the lower limit of the 95% confidence interval was greater than -20%, then Androxal would be concluded to be non-inferior to placebo in causing a 50% reduction in sperm concentrations."|3 months|ITT.||percentage of participants|||Number
683195|NCT01532414|Primary|Proportion (Percentage) of Androxal Treated Subjects With Testosterone in the Normal Range|"Proportion of pooled Androxal subjects with average serum concentration (Cavg) for T in the normal range (300 – 1040 ng/dL) after 12 weeks of treatment. Cavg will be calculated as the numerical average of 24-hour serial testosterone assessments at 0, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours after dosing.
If the lower limit of the 95% confidence interval for the Androxal treatment group at Week 12 is at least 67%, then the co-primary endpoint based on the Cavg for testosterone has been achieved.
FDA specified primary endpoint did not include comparison to placebo, thus the proportion of placebo subjects with average serum concentration (Cavg) for T in the normal range (300 – 1040 ng/dL) after 12 weeks of treatment was not calculated."|3 months|ITT population.||Percentage of Subjects|Participants|95% Confidence Interval|Number
683196|NCT01532362|Secondary|Effect of Apricoxib on Levels of CD4+CD25+ T Regulatory Cells in Peripheral Blood.Also,Biomarkers of Apoptosis Resistance,Angiogenesis,Invasion and Immunity Will be Tested in the Lab to Check How Effective Apricoxib is in Inhibiting These Proteins.|Peripheral blood from patients with NSCLC has been reported to have an increase in the percentages of CD4+CD25+ T reg cells.In contrast <10% of the PBLs of normal donors have this phenotype. As such, CD4+CD25+ cells will be assessed in addition to FOXP3 levels in PBL. In addition, exploration of COX-2 dependent biomarkers of apoptosis resistance, angiogenesis, invasion, and immunity will be studied. COX-2, FOXP3, IL-10, IL-12, MDC, CXCR4 and survivin will be analyzed in plasma.|7 days||||||
683315|NCT01529385|Secondary|Physical Activity Level|Physical activity monitors will be used to assess physical activity patters of participants for 48 hours prior to initiating sock usage and for 48 hours after the participants have worn the socks for four weeks.|baseline and after four weeks of wearing the socks|physical activity measurements were only made for a sub-sample of the study's complete sample||steps||Standard Deviation|Mean
683197|NCT01532362|Primary|Compare Level of CD4+CD25high T Lymphocyte Regulatory Cells in Peripheral Blood Lymphocytes and Tumor Infiltrating Lymphocytes From Surgical Resection Specimens of Subjects With Early Stage NSCLC Who Have Received Apricoxib to Those Who Have Not|As part of the trial, forty eligible subjects will be randomly assigned to receive Apricoxib 400 mg orally once daily or no drug intervention for a 7 day period (Days 0-6) prior to surgical resection of the lung tumor but between the two surgeries. Peripheral blood and urine will be obtained on Days 0 and 7 from both groups (prior to surgical incision). Bronchoalveolar lavage (BAL) and lymph node tissue will be obtained on Days 0 and 7. TIL will be obtained from surgical resection specimens of the primary lung tumor only on Day 7|7 days|No analysis occurred|||||
683198|NCT01532349|Primary|Change in Serum Hepcidin With Vitamin D Intervention for Children With Chronic Kidney Disease|The null hypothesis to be tested is that Vitamin D supplementation will not be associated with a decrease in serum hepcidin over the study period. Statistical analysis will be performed as intention-to-treat.|change from baseline to up to three months|||ng/ml||Inter-Quartile Range|Median
683199|NCT01532141|Secondary|AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to Last Observed Concentration||pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose|||ng.h/mL||Standard Deviation|Mean
683200|NCT01532141|Secondary|Time of Occurrence of Cmax (Tmax)|6-mL blood samples for the determination of plasma concentrations of BIA 9-1067 and/or rasagiline will be drawn by direct venipuncture or via an intravenous catheter into potassium ethylenediaminetetraacetic acid(EDTA)Vacutainers|pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose|||hours||Full Range|Median
683201|NCT01532141|Primary|Cmax - Maximum Observed Plasma Drug Concentration||pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose|||ng/mL||Standard Deviation|Mean
683202|NCT01532128|Secondary|AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to Last Observed Concentration||pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose|||ng.h/mL||Standard Deviation|Mean
683203|NCT01532128|Secondary|Tmax - Time of Occurrence of Cmax||pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose|||hours||Full Range|Median
683204|NCT01532128|Primary|Cmax - Maximum Observed Plasma Concentration||pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose|||ng/mL||Standard Deviation|Mean
683205|NCT01531998|Secondary|Number of Participants With Response|Overall response defined as number of participants with International Myeloma Working Group Uniform Response Criteria: Complete Response (CR): Negative immunofixation serum & urine, Disappearance soft tissue plasmacytomas & =/<5% plasma cells in bone marrow; Stringent Complete Remission: CR + Normal Normal free light chain (FLC) ratio & Absence clonal cells in bone marrow by Immunohistochemistry/ immunofluorescence; Very Good Partial Response (VGPR): Serum & urine M-protein detectable by immunofixation but not on electrophoresis or 90%> reduction in serum M-protein +urine M-protein level <100mg per 24 hour; Partial Remission (PR): =/>50% reduction serum M-protein & reduction in 24-hour urinaryMprotein by >90% or to < 200mg per 24 hour, =/>50% reduction of serum M-protein & reduction in 24-hour urinary Mprotein by >90%/or <200mg, and if present at baseline, a >50% reduction in size of soft tissue plasmacytomas; Stable Disease: Not CR, VGPR, PR Or Progressive disease|Evaluated after eight cycles of 21 days.|||participants|||Number
683206|NCT01531998|Primary|Maximum Tolerated Dose (MTD) of Siltuximab|Maximum tolerated dose (MTD) defined as follows: At first dose level, if greater than 1 out of 3 patients or greater than 1 out of 6 patients experience dose limiting toxicity (DLT), the dose level exceeds the maximum tolerated dose (MTD). Dose limiting toxicity (DLT) defined as toxicities graded in severity according to the guidelines outlined in the NCI-Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.|21 days|||mg/kg|||Number
683207|NCT01531725|Secondary|Major Adverse Cardiac Events (MACE)|MACE is defined as a composite of death, myocardial infarction, target lesion revascularization and coronary artery bypass grafting.|at 180 days post procedure|Patients with follow up available either 180 or 360 days post procedure.||participants|||Number
683208|NCT01531725|Primary|Target Vessel Failure (TVF)|Target vessel failure is defined as composite of revascularization, recurrent myocardial infarction, or cardiac death.|at 180 days post procedure|Patients with follow up data available either 180 or 360 days post procedure.||participants|||Number
683209|NCT01531387|Secondary|Quality of Life|Standard Quality of Life measure will be taken during specific time points, as well as one newly-developed Sickle Cell Disease Quality of Life measure.|30 months|No participants reached 30 months of treatment prior to study termination; therefore, the secondary outcome measures were not analyzed.|||||
683210|NCT01531387|Secondary|Cumulative Incidence of Non-Neurological Events|The cumulative incidence of non-neurological sickle cell-related events, including vaso-occlusion and splenic sequestration, will be estimated over the treatment period for both standard and alternative arms.|30 months|No participants reached 30 months of treatment prior to study termination; therefore, the secondary outcome measures were not analyzed.|||||
683211|NCT01531387|Secondary|Cumulative Incidence of Neurological Events|The cumulative incidence of neurological events as a secondary endpoint, which include both stroke and non-stroke neurological events, will be determined over the treatment period for both standard and alternative arms.|30 months|No participants reached 30 months of treatment prior to study termination; therefore, the secondary outcome measures were not analyzed.|||||
683212|NCT01531387|Secondary|Serial TCD Velocities|This secondary outcome measure will be the highest TAMV obtained in specific arteries. Serial TCD velocities are measured throughout the SCATE trial and will be compared to the baseline value.|30 months|No participants reached 30 months of treatment prior to study termination; therefore, the secondary outcome measures were not analyzed.|||||
683213|NCT01531387|Primary|Conversion to Abnormal Maximum TAMV|The primary endpoint of the SCATE trial is the cumulative incidence of conversion to abnormal maximum TAMV (time-averaged mean velocity) measured by transcranial doppler (TCD) ultrasonography. Subjects must have conditional velocities at baseline, defined as 170 - 199 cm/sec, which indicate moderate stroke risk. Abnormal velocities are defined as ≥ 200 cm/sec, which indicate high stroke risk. The number of conversions from conditional velocities to abnormal velocities in each treatment arm will be compared as the primary outcome.|30 months|No participants reached 30 months of treatment prior to study termination; therefore, the primary outcome measure was not analyzed.|||||
683316|NCT01529385|Primary|Foot Edema|The circumference of the foot was measured by a tape measure.|change from baseline after 4 weeks of sock usage|||cm||95% Confidence Interval|Mean
683317|NCT01529385|Primary|Ankle Brachial Index|ratio of systolic blood pressure of ankle relative to systolic blood pressure of arm|change from baseline after 4 weeks of sock usage|||unit-less ratio data||95% Confidence Interval|Mean
683234|NCT01531335|Secondary|Insulin Requirements|This is an indirect measure of glycemic control, and is reported as a daily average.|Daily until day 21 or discharge from ICU|||International Unit of insulin||Standard Deviation|Mean
683235|NCT01531335|Primary|SOFA (Sequential Organ Failure Assessment) Score|SOFA score evaluates six systems: respiratory, cardiovascular, coagulation, Central Nervous System, liver and renal. Each system gets a score from 0 (normal) to 4 (abnormal) and the sum of each score defines the final SOFA score, which 24 is the maximum score (high risk of morality) and 0 is the minimum score (low risk of mortality).|48 hours since nutritional regime starts|||units on a scale||Standard Deviation|Mean
683236|NCT01531205|Secondary|Incidence of Detecting Circulating Tumor Cells (CTC)|To determine the feasibility of detecting circulating tumor cells in this patient population. CTC results per patient in milliliters.|One Year|All participants||CTC/mL|||Number
683237|NCT01531205|Secondary|Incidence of Perioperative and Postoperative Morbidity|Number of events. To access the perioperative and postoperative morbidity with salvage surgery after neoadjuvant hormonal ablation and Cabazitaxel.|One Year|Participants who proceeded to surgery||events|||Number
683238|NCT01531205|Secondary|Incidence of Complete Response (CR)|Percentage of participants with CR post surgery. To evaluate the pathological complete response rate to androgen ablation plus Cabazitaxel in patients with locally recurrent prostate cancer following radiation therapy. Pathological Complete Response (pCR): Participants with no residual cancer in the local resection specimen and pelvic lymph nodes will be considered pCR.|One Year|Participants who proceeded to surgery||percentage of participants|||Number
683239|NCT01531205|Secondary|Incidence of PSA Progression Free Survival (PFS)|Percentage of participants with stable (has not increased) or undetectable PSA post surgery. To assess Prostate-specific antigen(PSA)-progression free survival and prostate cancer specific survival for patients treated by chemohormonal therapy followed by salvage surgery for biopsy proven androgen-dependent high-risk locally recurrent prostate cancer following radiation therapy.|Four Months|Participants who proceeded to surgery||percentage of participants|||Number
683240|NCT01531205|Primary|Surgical Margin Negative Rate (SM Rate)|Post surgery percentage of participants with negative surgical margin. To determine the surgical margin negative rate in patients who have undergone chemohormonal therapy followed by surgery for biopsy proven androgen-dependent high risk locally recurrent prostate cancer following primary radiation therapy. Margin: The edge or border of the tissue removed in cancer surgery. The margin is described as negative or clean when the pathologist finds no cancer cells at the edge of the tissue, suggesting that all of the cancer has been removed. The margin is described as positive or involved when the pathologist finds cancer cells at the edge of the tissue, suggesting that all of the cancer has not been removed.|One Year|Participants who proceeded to surgery||percentage of participants|||Number
683241|NCT01530997|Secondary|The Rosenbek Penetration Aspiration Scale|"The Rosenbek Penetration Aspiration Scale will be used to quantify dysphagia. It is an 8-point, equal-appearing interval scale to describe penetration and aspiration events. The measure was used for thin substances, pureed substances, and solid substances.
1. Material does not enter airway 2. Material enters the airway, remains above the vocal folds, and is ejected from the airway. 3. Material enters the airway, remains above the vocal folds, and is not ejected from the airway. 4. Material enters the airway, contacts the vocal folds, and is ejected from the airway. 5. Material enters the airway, contacts the vocal folds, and is not ejected from the airway. 6.Material enters the airway, passes below the vocal folds, and is ejected into the larynx or out of the airway. 7. Material enters the airway, passes below the vocal folds, and is not ejected from the trachea despite effort. 8. Material enters the airway, passes below the vocal folds, and no effort is made to eject."|Prior to CRT and 4-8 weeks after completion of CRT|||units on a scale||Standard Deviation|Mean
683242|NCT01530997|Secondary|The Eating Assessment Tool (EAT-10) Composite Score|The EAT-10 is a 10 item, validated self-administered instrument for documenting dysphagia severity. This questionnaire uses symptom-specific scores to assess dysphasia with solids, liquids, and pills as well as the impact of dysphagia on mental, social, and physical health. Higher raw scores represent worse QoL. All items have a 0-4 scale where 0 represents no problem and 4 represents severe problem. Total score can range from 0 to 40.|Prior to CRT, 4-8 weeks after CRT, follow-up visits for 2 years after CRT|||units on a scale||95% Confidence Interval|Mean
683258|NCT01530464|Primary|Maximum Plasma Concentration (Cmax) of Theophylline (Aminophylline) and Ambrisentan When Administered Alone or in Combination|Aminophylline Alone (Single Dose of 500mg Aminophylline) Aminophylline in Presence of Ambrisentan (Combined Single Dose of 500mg Aminophylline and 5mg Ambrisentan) Ambrisentan Alone (Single Dose of 5mg Ambrisentan) Ambrisentan in Presence of Aminophylline (Combined Single Dose of 500mg Aminophylline and 5mg Ambrisentan)|24h after dosing|||ng/ml||Standard Deviation|Median
683243|NCT01530997|Secondary|European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL|The EORTC QLQ-C30 is a cancer-specific instrument with 30 questions which incorporates 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social); 9 symptom scales (fatigue, pain, nausea and vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties); and a global health and quality-of-life scale. Most questions used 4 point scale (1 'Not at all' to 4 'Very much'); 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). The scores of these scales were averaged from the scores of the component items, transformed and analyzed on a 0 - 100 scale. A higher score=better level of functioning or greater degree of symptoms.|Prior to CRT, 4-8 weeks after CRT, follow-up visits for 2 years after CRT|||units on a scale||95% Confidence Interval|Mean
683244|NCT01530997|Secondary|European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35|"The head & neck cancer module of the EORTC QLQ comprises 35 questions assessing symptoms and side effects of treatment, social function and body image/sexuality.
The head & neck cancer module incorporates seven multi-item scales that assess pain, swallowing, senses (taste and smell), speech, social eating, social contact and sexuality. There are also eleven single items. Most questions used 4 point scale (1 'Not at all' to 4 'Very much'); several single item questions (Pain killers, nutritional supplements, feeding tube, weight loss, and weight gain) were just coded as no=1, yes=2. The scores of these scales were averaged from the scores of the component items, transformed and analyzed on a 0 - 100 scale. For all items and scales, high scores indicate more problems (i.e. there are no function scales in which high scores would mean better functioning)."|Prior to CRT, 4-8 weeks after CRT, follow-up visits for 2 years after CRT|||units on a scale||95% Confidence Interval|Mean
683245|NCT01530997|Secondary|Overall Survival Rate|The percentage of participants who are still alive from the start of treatment.|Median follow-up was 36 months with a range of 5-53 months.|||percentage of participants|||Number
683246|NCT01530997|Secondary|Distant Metastases Free Survival|Distant metastases free survival is the percentage of subjects in a study who have survived without cancer spread.|the median follow-up was 36 months with a range of|||percentage of participants|||Number
683247|NCT01530997|Secondary|Cause-Specific Survival|Cause-specific survival is the percentage of participants who have not died from low-risk low-risk OPSCC.|The median follow-up was 36 months with a range of 5-53 months|||percentage of participants|||Number
683248|NCT01530997|Secondary|Regional Control|Regional control is the percentage of participants who displayed control of cancer in sites that represent the first stages of spread from the local origin.|Median follow-up was 36 months with a range of 5-53 months|||percentage of participants|||Number
683249|NCT01530997|Secondary|Two-Year Local Control|Local control is the arrest of cancer growth at the site of origin.|Median follow-up was 36 months with a range of 5-53 months|||percentage of participants|||Number
683250|NCT01530997|Primary|Pathologic Complete Response Rate After De-escalated CRT in HPV-positive and/or p16 Positive Oropharyngeal Squamous Cell Carcinoma (OPSCC).|Pathologic Complete Response Rate is defined as no evidence of residual viable cancer in the evaluated pathological specimens.|6 to 14 weeks after the last patient is enrolled, or approximately 24 to 32 months after study being opened|Following the completion of chemoradiation therapy (CRT), 1 patient refused the planned surgical evaluation and 43 patients were evaluated.||Participants|||Count of Participants
683251|NCT01530880|Secondary|Bleeding Incidence|Incidence of bleeding (defined by a priori criteria)|Up to 14 days|PI left before data could be analyzed and data collection was incomplete.|||||
683252|NCT01530880|Secondary|Difference in Cost Between Ibuprofen and Acetaminophen|Cost analysis of aggressive fever control (AFC) between patients randomized to either intravenous ibuprofen infusion or standard of care (oral acetaminophen).|Up to 14 days|PI left before data could be analyzed and data collection was incomplete.|||||
683253|NCT01530880|Secondary|Mean Difference in Inflammatory Markers|Mean difference in markers of inflammation between IV ibuprofen and standard of care groups|Up to 14 days|PI left before data could be analyzed and data collection was incomplete.|||||
683254|NCT01530880|Primary|Prevalence of Fever Burden|Reduction in fever burden (degrees C x hours) with intravenous ibuprofen infusion as compared to oral acetaminophen over duration of treatment. Fever burden is calculated hourly by subtracting each patient's recorded temperature (from either a bladder or esophageal temperature probe) from 37 degrees C.|Up to14 days|PI left before data could be analyzed and data collection was incomplete.|||||
683255|NCT01530477|Primary|Short Term Precision Comparison Across Three DXA Devices|"BMD precision will be reported across three DXA devices in major skeletal and body composition sites. The short-term precision was calculated as RMS-SD (root mean square standard deviation) over the mean for each cohort. The skeletal cohort will not have short-term precision value for body composition indexes due to the different region of measurement. The same will apply to the body composition cohort. As the result, the Skeletal & Body Composition cohort identified in participant flow and overall study summary will not have an analysis provided."|Less than 6 months|||Percentage of variance|||Number
683256|NCT01530464|Primary|Area Under the Curve Post Dosing (AUC_0-infinity) of Theophylline (Aminophylline) and Ambrisentan When Administered Alone or in Combination|"Aminophylline Alone (Single Dose of 500mg Aminophylline) Aminophylline in Presence of Ambrisentan (Combined Single Dose of 500mg Aminophylline and 5mg Ambrisentan) Ambrisentan Alone (Single Dose of 5mg Ambrisentan) Ambrisentan in Presence of Aminophylline (Combined Single Dose of 500mg Aminophylline and 5mg Ambrisentan)
Blood sample collections for plasma Ambrisentan and Theophylline determinations at 0-hour (pre-dose), and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post dose"|24h after dosing|||h*ng/ml||Standard Deviation|Median
683257|NCT01530464|Primary|Area Under the Curve Within 24 Hours Post Dosing (AUC_0-24 Hours) of Theophylline (Aminophylline) and Ambrisentan When Administered Alone or in Combination|"Aminophylline Alone (Single Dose of 500mg Aminophylline) Aminophylline in Presence of Ambrisentan (Combined Single Dose of 500mg Aminophylline and 5mg Ambrisentan) Ambrisentan Alone (Single Dose of 5mg Ambrisentan) Ambrisentan in Presence of Aminophylline (Combined Single Dose of 500mg Aminophylline and 5mg Ambrisentan)
Blood sample collections for plasma Ambrisentan and Theophylline determinations at 0-hour (pre-dose), and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post dose"|24h after dosing|||h*ng/ml||Standard Deviation|Median
683274|NCT01529827|Secondary|Median Time to Neutrophil Engraftment|Median time to recovery of absolute neutrophil count >=500/uL for 3 consecutive days. Summarized using standard descriptive statistics along with corresponding 95% confidence intervals.|Day 100|All treated and eligible patients||days||Full Range|Median
683259|NCT01530464|Primary|Time Until Maximum Plasma Concentration (Tmax) of Theophylline (Aminophylline) and Ambrisentan When Administered Alone or in Combination|"Aminophylline Alone (Single Dose of 500mg Aminophylline) Aminophylline in Presence of Ambrisentan (Combined Single Dose of 500mg Aminophylline and 5mg Ambrisentan) Ambrisentan Alone (Single Dose of 5mg Ambrisentan) Ambrisentan in Presence of Aminophylline (Combined Single Dose of 500mg Aminophylline and 5mg Ambrisentan)
Blood sample collections for plasma Ambrisentan and Theophylline determinations at 0-hour (pre-dose), and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post dose"|24h after dosing|||hours||Standard Deviation|Median
683260|NCT01530464|Primary|Plasma Halflife of Theophylline (Aminophylline) and Ambrisentan When Administered Alone or in Combination|"Aminophylline Alone (Single Dose of 500mg Aminophylline) Aminophylline in Presence of Ambrisentan (Combined Single Dose of 500mg Aminophylline and 5mg Ambrisentan) Ambrisentan Alone (Single Dose of 5mg Ambrisentan) Ambrisentan in Presence of Aminophylline (Combined Single Dose of 500mg Aminophylline and 5mg Ambrisentan)
Blood sample collections for plasma Ambrisentan and Theophylline determinations at 0-hour (pre-dose), and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post dose"|24 hours after dosing|||hours||Standard Deviation|Median
683261|NCT01530464|Primary|Mean Number of Adverse Events Following Each Dose|"Dosing schedule:
Aminophylline Alone (Single Dose of 500mg Aminophylline) Ambrisentan Alone (Single Dose of 5mg Ambrisentan) Ambrisentan and Aminophylline (Combined Single Dose of 500mg Aminophylline and 5mg Ambrisentan)"|48 h following each dose|||Mean number of adverse events||Standard Deviation|Mean
683262|NCT01530399|Primary|Chest Tube Drainage at 12 Hours After Surgery||12 hours post CABG|||mL||Inter-Quartile Range|Median
683263|NCT01530334|Secondary|Time to Worsening of Disease Related Symptoms|Time to worsening of disease related symptoms (LCS) Time to worsening of disease-related symptoms based on FACT-L LCS was defined as the interval from the date of enrollment to the first visit response of ‘worsened’ without a subsequent response of ‘improved’ or ‘no change’ within 21 days (or to the last assessment), death due to any cause, or early discontinuation from the study. Time to worsening was censored at the last non-missing assessment visit if the worsening was not observed.|every 6 weeks after the Start of Study Treatment until the worsening of desease related symptoms or time of data cut off (6 months after the last patient has started study treatment)|Analysis performed on EFS & FAS population||days|Participants|95% Confidence Interval|Median
683264|NCT01530334|Secondary|Treatment Duration With Gefitinib|Treatment duration was calculated from the date of the first to the date of the last intake.|every 6 weeks after the Start of Study Treatment until discontinuation of drug or time of data cut off (6 months after the last patient has started study treatment)|Analysis performed on EFS & FAS population||days|Participants|95% Confidence Interval|Median
683265|NCT01530334|Secondary|Overall Survival (OS)|OS was calculated as the time from the first dose until the day of death from any cause. Any patient not known to have died at the time of data analysis was censored at the time of the last follow-up date.|every 6 weeks after the Start of Study Treatment until death or time of data cut off (6 months after the last patient has started study treatment)|Analysis conducted both in FAS and EFS population||days|Participants|95% Confidence Interval|Median
683266|NCT01530334|Secondary|Progression Free Survival|Progression free Survival was calculated as the time from the first dose of gefitinib study treatment until the date of (i) progression or (ii) death from any cause in the absence of progression.|every 6 weeks after the Start of Study Treatment until objective disease progression or time of data cut off (6 months after the last patient has started study treatment)|PFS was analysed on FAS and EFS population||Days|Participants|95% Confidence Interval|Median
683267|NCT01530334|Primary|Clinical Benefit Rate|"Clinical benefit rate is the sum of patients with a best visit response of Complete Response, Partial Response or Stable Desease Objective Response Rate is the sum of Complete response (CR) and Partial Response (PR) response.
Evaluated by recist criteria v 1.1., for target lesions and assesed by CT or MRI: Complete Response (CR), Disapperance of all target lesions; Partial Response (PR),>=30% decrease in the sum of longest diamteter of target lesions, Stable Desease (SD) defined as no progression for>= 6 weeks. Objective response rate (RR)=CR+PR"|every 6 weeks after the Start of Study Treatment until objective disease progression or time of data cut off (6 months after the last patient has started study treatment)|CBR was analyzed both on FAS and EFS population||Patients|Participants||Number
683268|NCT01530334|Primary|Objective Response Rate|"Objective Response Rate is the sum of Complete response (CR) and Partial Response (PR) response.
Evaluated by recist criteria v 1.1., for target lesions and assesed by CT or MRI: Complete Response (CR), Disapperance of all target lesions; Partial Response (PR),>=30% decrease in the sum of longest diamteter of target lesions; Objective response rate (RR)=CR+PR"|every 6 weeks after the Start of Study Treatment until objective disease progression or time of data cut off (6 months after the last patient has started study treatment)|Analysis performed both in the FAS population (i.e. all enrolled patients into the study) and in EFS population (i.e. all screened patients who entered and received at least one dose of study agent)||Patients|Participants||Number
683269|NCT01530243|Other Pre-specified|Pain|The visual analogue scale (VAS) was used to evaluate the pain at the time of voiding. This VAS scoring ranges from 0 to 10. The higher values represent worse outcomes, having more pain.|Expected 2 weeks later|||units on a scale||Standard Deviation|Mean
683270|NCT01530243|Secondary|Quality of Life|The Quality of life of patients was evaluated using single question in IPSS questionnaire in which each of patients received scoring from 0 to 6. The higher values represent the worse quality of life.|Expected 2 weeks later|||units on a scale||Standard Deviation|Mean
683271|NCT01530243|Primary|Lower Urinary Tract Symptoms (LUTS)|LUTS was evaluated using the International Prostate Symptom Score (IPSS) questionnaire perioperatively. The IPSS constitutes of seven questions assigned score from 0 to 5 to evaluate the severity of LUTS in patients. Total scoring of IPSS ranges from 0 to 35, asymptomatic to very symptomatic. The more the score on scale is, the worse the outcome is.Therefore, the higher values represent worse outcomes.|Expected average of 2 weeks|The more the score on scale is, the worse the outcome is.Therefore, the higher values represent worse outcomes.||units on a scale||Standard Deviation|Mean
683272|NCT01530087|Secondary|Security|wear time leakage barrier erosion|30 days|Study was stopped ; no data are available|||||
683273|NCT01530087|Primary|Peristomal Skin Condition|mean irritation score using a categorical scale with range of 1(normal) to 5(eroded or heaemorrhagic dermatitis)|1 - 30 days|Study was stopped due to inability to inability to enroll. No data are available for any outcome measures.|||||
683276|NCT01529827|Secondary|Clinical Response|"Patients will be followed according to response criteria as referenced in BMT SOP Standards of Therapy last updated 2008. Clinical Response = CR + PR.
Complete Response Requires all of the following:
Serum and urine negative for monoclonal proteins by immunofixation
Normal free light chain ratio
Plasma cells in marrow < 5%
Partial Response (PR) Requires any of the following:
- ≥ 50% reduction in current serum monoclonal protein levels > 0.5 g/dL or urine light chain levels > 100 mg/day with a visible peak or free light chain levels > 10mg/dL
Progressive Disease (PD) Requires any of the following:
If progressing from CR, any detectable monoclonal protein or abnormal free light chain ratio (light chain must double)
If progressive from PR or SD, ≥ 50% increase in the serum M protein to > 0.5 g/dL,or ≥ 50% increase in urine M protein to > 200mg/day with visible peak present.
Free light chain increase of ≥ 50% to"|In the first 100 days from day 0 of transplant|All treated and eligible patients||percentage of participants||95% Confidence Interval|Number
683277|NCT01529827|Primary|Transplant Related Mortality (TRM)|Day 100 transplant related mortality (TRM). An exact 95% confidence interval will be provided.|In the first 100 days from day 0 of transplant|All treated and eligible patients||percentage of participants||95% Confidence Interval|Number
683278|NCT01529645|Primary|Percentages of Subjects With Diphtheria and Tetanus Antitoxin Units >= 0.1/mL After Vaccination|The percentages of subjects demonstrating diphtheria and tetanus antitoxin units >= 0.1/mL following vaccination with different antigenic formulations of TdaP booster vaccine, is compared to the response to commercially available comparator.|Day 1 (baseline) and Day 30 post vaccination|Analysis was done on the per-protocol population.||percentages of subjects||95% Confidence Interval|Number
683279|NCT01529645|Primary|GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies for T5D4aP1, T5D4aP2 and T5D4aP4 Booster Groups Against Pertussis Antigens|The GMRs of post-vaccination versus pre-vaccination GMCs of antibodies against pertussis antigens (PT, FHA and PRN) for TdaP booster groups and for licensed comparator are reported.|Day 30 post vaccination/baseline (Day 1)|Analysis was done on the per-protocol population.||Ratio||95% Confidence Interval|Geometric Mean
683280|NCT01529645|Primary|GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Booster Groups Against Pertussis Antigens|The GMRs of post-vaccination versus pre-vaccination GMCs of antibodies against pertussis antigens (PT, FHA and PRN) for TdaP booster groups and for licensed comparator are reported.|Day 30 post vaccination/baseline (Day 1)|Analysis was done on the per-protocol population.||Ratio||95% Confidence Interval|Geometric Mean
683281|NCT01529645|Primary|Geometric Mean Ratios (GMRs) of Post Vaccination Versus Pre Vaccination GMCs of Antibodies in aP1, aP2, aP4 Booster Groups Against Pertussis Antigens|The GMRs of post-vaccination versus pre-vaccination GMCs of antibodies against pertussis antigens (PT, FHA and PRN) for different antigenic formulations of aP booster vaccines and for licensed comparator are reported.|Day 30 post vaccination/baseline (Day 1)|Analysis was done on the per-protocol population.||Ratio||95% Confidence Interval|Geometric Mean
683282|NCT01529645|Secondary|GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies Against Diphtheria and Tetanus Antigens|The GMRs of post vaccination versus pre vaccination GMCs of antibodies against diphtheria and tetanus antigens for different formulations of TdaP booster and commercially available comparator versus GMCs at baseline are reported.|Day 30 post vaccination/Day 1|Analysis was done on the per-protocol population.||Ratio||95% Confidence Interval|Geometric Mean
683283|NCT01529645|Secondary|GMCs of Antibodies Against Diphtheria and Tetanus Antigens Following Vaccination|The GMCs of antibodies against diphtheria and tetanus antigens following vaccination with different formulations of TdaP booster are compared with the response to the commercially available comparator.|Day 1 (baseline) and Day 30 post vaccination|Analysis was done on the per-protocol population.||IU/mL||95% Confidence Interval|Geometric Mean
683284|NCT01529645|Secondary|Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination.|Comparison of antibody responses against pertussis antigens (PT, FHA and PRN), following vaccination with different antigenic formulations of aP and TdaP booster vaccines and licensed comparator, are reported in terms of the percentages of subjects demonstrating 2- and 4-fold increase in GMCs from baseline.|Day 30 post vaccination|Analysis was done on the per-protocol population.||percentage of subjects||95% Confidence Interval|Number
683285|NCT01529645|Primary|GMCs of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens Following Vaccination|The GMCs of antibodies as measured by enzyme-linked immunosorbent assay (ELISA) in TdaP booster groups, against pertussis antigens (PT, FHA and PRN), following vaccination with different antigenic formulations of TdaP booster versus the response to the commercially available comparator are reported.|Day 1 (baseline) and Day 30 post vaccination|Analysis was done on the per-protocol population.||µg/mL||95% Confidence Interval|Geometric Mean
683286|NCT01529645|Primary|GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens Following Booster Vaccination|The GMCs of antibodies as measured by enzyme-linked immunosorbent assay (ELISA) in TdaP Booster Groups against pertussis antigens (PT, FHA and PRN), following vaccination with different antigenic formulations of TdaP booster versus the response to the commercially available comparator are reported.|Day 1 (baseline) and Day 30 post vaccination|Analysis was done on the per-protocol population.||µg/mL||95% Confidence Interval|Geometric Mean
683287|NCT01529645|Primary|Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens Following Booster Vaccination|The GMCs of antibodies as measured by enzyme-linked immunosorbent assay (ELISA) on aP booster groups, against pertussis antigens pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN), following vaccination with different antigenic formulations of aP versus the response to the commercially available comparator are reported.|Day 1 (baseline) and Day 30 post vaccination|Analysis was done on the per-protocol population, ie, all subjects who correctly received the vaccine, and provided evaluable serum samples at the relevant time points and had no major protocol violation as defined prior to unblinding.||µg/mL||95% Confidence Interval|Geometric Mean
683288|NCT01529645|Primary|The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine|The safety profiles of different antigenic formulations of the aP and TdaP booster vaccines were assessed in terms of the number of subjects reporting any unsolicited adverse events (AEs) between day 1 to day 30 , serious adverse events (SAEs) and AEs leading to premature withdrawal between day 1 to day 365, after vaccination.|From day 1 to day 365|Analysis was done on the safety set.||participants|||Number
683289|NCT01529645|Primary|The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine|The safety profiles of different antigenic formulations of the aP and TdaP booster vaccines were assessed and compared to that of licensed comparator in terms of the number of subjects reporting solicited local and systemic adverse events and other adverse events after vaccination.|Day 1 through 7 after vaccination|Analysis was done on the safety set, ie, all subjects who received the study vaccination and provided post vaccination safety data.||participants|||Number
683290|NCT01529632|Secondary|Change From Baseline in Percentage of Days With 'no Daytime Symptoms' Over 28 Days of Treatment|The mean total symptom scores and mean individual symptom scores for the patient were calculated for the whole study period. The mean change from baseline in the total scores and in the individual scores were summarized by treatment and were analyzed for the percentage of 'nights with no nighttime awakenings'. The symptom variables for the whole active treatment period was analyzed using the similar MIXED model as for the primary endpoint, with the baseline FEV1 term being replaced by the respective baseline symptom variables.|28 days|The Modified per protocol set (PPS) was defined post-DBL and included all patients with available data and without any major protocol deviations or criteria or GCP finding causing exclusion. Patients were analyzed according to the treatment to which they were randomized.||percentage of days||Standard Deviation|Mean
683291|NCT01529632|Secondary|Change From Baseline in the Mean Daily, (Daytime and Nighttime Combined) Number of Puffs of Rescue Medication Used Over 28 Days of Treatment|The number of puffs of rescue medication taken in the previous 12 hours was recorded in the Patient Diary in the morning and evening. The total number of puffs of rescue medication per day over the whole active treatment period was calculated and divided by the total number of days with non-missing rescue data to derive the mean daily number of puffs of rescue medication taken for the patient. If the number of puffs was missing for part of the day (either morning or evening) then a half day was used in the denominator.|Baseline and 28 days|"The Per Protocol Set includes the Full analysis Set patients with available data and without any major protocol deviations or criteria causing exclusion.
Patients were analyzed according to the treatment to which they were randomized."||puffs||Standard Deviation|Mean
683292|NCT01529632|Secondary|Time Course of Forced Expiratory Volume in One Second (FEV1) (Pre-dose to 4 Hours Post Dose) on Day 28|Time course of Forced Expiratory Volume in 1 second (FEV1) was measured at -45 min, -15 min predose, 5 min, 30 min, 1 hr, 2hr, 3hr and 4 hr post-dose on Day 28. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.|-45 min, -15 min predose, 5 min, 30 min, 1 hr, 2hr, 3hr and 4 hr post-dose on Day 28|The Per Protocol Set includes the Full analysis Set patients with available data and without any major protocol deviations or criteria causing exclusion. Patients were analyzed according to the treatment to which they were randomized.||Liters||Standard Error|Least Squares Mean
683293|NCT01529632|Secondary|Peak Forced Expiratory Volume in 1 Second (FEV1) on Days 1 and 28 Post-dose|Spirometry was conducted according to internationally accepted standards. Peak FEV1 is the maximum FEV1 recorded in the period between 5 minutes and 4 hours post dose. Analysis of Covariance was carried out with a mixed model that used (period) baseline, defined as the value of FEV1 measured prior to the first study drug intake in the period, as a covariate.|5 min - 4 hr at Days 1 and 28|"The Per Protocol Set includes the Full analysis Set patients with available data and without any major protocol deviations or criteria causing exclusion.
Patients were analyzed according to the treatment to which they were randomized."||Liters||Standard Error|Least Squares Mean
683294|NCT01529632|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) 0-4 Hours at Day 28|Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) 0-4h at Day 28 was measured via spirometry conducted according to internationally accepted standards. Measurements were made at 0, 5, 15, and 30 minutes; and 1, 2, 3 and 4 hours post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time. Mixed model used: AUC FEV1 = treatment + baseline FEV1 + FEV1 reversibility components + baseline smoking status + baseline ICS use + country + center (country) + error. Center was included as a random effect nested within country.|0, 5, 15, and 30 minutes; and 1, 2, 3 and 4 hours post-dose at Day 28|"The Per Protocol Set includes the Full analysis Set patients with available data and without any major protocol deviations or criteria causing exclusion.
Patients were analyzed according to the treatment to which they were randomized."||Liters||Standard Error|Least Squares Mean
683295|NCT01529632|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) 0-4 Hours at Day 1|Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) 0-4h at Day 1 was measured via spirometry conducted according to internationally accepted standards. Measurements were made at 0, 5, 15, and 30 minutes; and 1, 2, 3 and 4 hours post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time. Mixed model used: AUC FEV1 = treatment + baseline FEV1 + FEV1 reversibility components + baseline smoking status + baseline ICS use + country + center (country) + error. Center was included as a random effect nested within country.|0, 5, 15, and 30 minutes; and 1, 2, 3 and 4 hours post-dose at Day 1|"The Per Protocol Set includes the Full analysis Set patients with available data and without any major protocol deviations or criteria causing exclusion.
Patients were analyzed according to the treatment to which they were randomized."||Liters||Standard Error|Least Squares Mean
683296|NCT01529632|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) After 28 Days of Blinded Treatment|Spirometry was conducted according to internationally accepted standards. Trough FEV1 is defined as the average of the 23 hour 15 minute and 23 hour 45 minute post-dose FEV1 readings measured at day 29, after 28 days of treatment. Mixed model: Trough FEV1 = treatment + baseline FEV1 + FEV1 reversibility components + baseline smoking status + baseline ICS use + country + center (country) + error. Center was included as a random effect nested within country.|Day 29|"The Per Protocol Set includes the Full analysis Set patients with available data and without any major protocol deviations or criteria causing exclusion.
Patients were analyzed according to the treatment to which they were randomized."||Liters||Standard Error|Least Squares Mean
683318|NCT01529385|Primary|Toe Brachial Index|ratio of systolic blood pressure of toe relative to systolic blood pressure of arm|change from baseline after 4 weeks of sock usage|||unit-less ratio data||95% Confidence Interval|Mean
683319|NCT01529385|Primary|Ankle Edema|The circumference of ankle was measured by a tape measure.|change from baseline after 4 weeks of sock usage|||cm||95% Confidence Interval|Mean
683320|NCT01529385|Primary|Calf Edema|The circumference of calf was measured by a tape measure.|change from baseline after 4 weeks of sock usage|||cm||95% Confidence Interval|Mean
683297|NCT01529515|Secondary|Change in Personal and Social Performance (PSP) Scale From Baseline to Endpoint in the Double-Blind Phase|The PSP scale measures personal and social functioning in the domains of: a) Socially useful activities, b) Personal and social relationships, c) Self-care, and d) Disturbing and aggressive behavior. The results of the assessment were converted to a numerical score which ranges from 1 to 100. A score lying between 71 and 100 indicates a mild degree of dysfunction; scores between 31 and 70 indicate varying degrees of difficulty, and a participant with a score of <=30 had functioning so poor that he or she required intensive supervision.|Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60)|"Intent-to-treat (ITT) double blind (DB) population included all participants who were randomly assigned to treatment during DB Phase and received at least 1 dose of DB study agent. Missing data was imputed using LOCF method. Here N (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure."||Units on a Scale||Standard Deviation|Mean
683298|NCT01529515|Secondary|Change in Clinical Global Impression Severity (CGI-S) Scale From Baseline to Endpoint in the Double-Blind Phase|The CGI-S rating scale is used to rate the severity of a participant's overall clinical condition on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe).|Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60)|"Intent-to-treat (ITT) double blind (DB) population included all participants who were randomly assigned to treatment during DB Phase and received at least 1 dose of DB study agent. Missing data was imputed using LOCF method. Here N (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure."||Units on a Scale||Standard Deviation|Mean
683299|NCT01529515|Secondary|Change in Positive and Negative Syndrome Scale (PANSS) (Total Score) From Baseline to Endpoint in the Double-Blind Phase|The PANSS provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items). Each item is rated 1 (absent) to 7 (extreme). The total score ranging from 30 to 210. Higher scores indicate more severe neuropsychiatric symptoms of schizophrenia.|Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60)|"Intent-to-treat (ITT) double blind (DB) population included all participants who were randomly assigned to treatment during DB Phase and received at least 1 dose of DB study agent. Missing data was imputed using LOCF method. Here N (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure."||Units on a Scale||Standard Deviation|Mean
683300|NCT01529515|Primary|Time to Relapse During the Double-Blind Phase|Time to relapse defined as the time between participant randomization into the double blind Phase and the first documentation of a relapse event. Median time to relapse was estimated by the Kaplan-Meier method.|Approximately Week 60|The intent-to-treat (ITT) double blind (DB) population included all participants who were randomly assigned to treatment during the Double-blind Phase and received at least one dose of Double-blind study agent.||Days||95% Confidence Interval|Median
683301|NCT01529502|Other Pre-specified|Endothelial Function|To assess Endothelial function by RHI at baseline, 10 minutes after blood transfusion, 1 hour after blood transfusion, 2 hours after blood transfusion and 4 hours after blood transfusion.|Before and after blood transfusion||||||
683302|NCT01529502|Other Pre-specified|Changes in Gene Expression|To assess concentration of changes in gene expression at baseline, 10 minutes after blood transfusion, 1 hour after blood transfusion, 2 hours after blood transfusion and 4 hours after blood transfusion.|Before and after blood transfusion||||||
683303|NCT01529502|Other Pre-specified|Activation of Inflammatory Lipid Mediators|To assess concentration of plasma activation of inflammatory lipid mediators at baseline, 10 minutes after blood transfusion, 1 hour after blood transfusion, 2 hours after blood transfusion and 4 hours after blood transfusion.|Before and after blood transfusion||||||
683304|NCT01529502|Other Pre-specified|Activation of Platelets|To assess concentration of plasma activation of platelets at baseline, 10 minutes after blood transfusion, 1 hour after blood transfusion, 2 hours after blood transfusion and 4 hours after blood transfusion.|Before and after blood transfusion||||||
683305|NCT01529502|Other Pre-specified|Concentration of Cytokines|To assess concentration of plasma cytokines at baseline, 10 minutes after blood transfusion, 1 hour after blood transfusion, 2 hours after blood transfusion and 4 hours after blood transfusion.|Before and after blood transfusion||||||
683306|NCT01529502|Other Pre-specified|Nitric Oxide Metabolites|To assess concentration of plasma Nitric oxide metabolites at baseline, 10 minutes after blood transfusion, 1 hour after blood transfusion, 2 hours after blood transfusion and 4 hours after blood transfusion.|Before and after blood transfusion||||||
683307|NCT01529502|Other Pre-specified|Hemolysis|To assess concentration of plasma Hemoglobin at baseline, 10 minutes after blood transfusion, 1 hour after blood transfusion, 2 hours after blood transfusion and 4 hours after blood transfusion.|before and after blood transfusion||||||
683308|NCT01529502|Secondary|Endothelial Function: Reactive Hyperemia Index|Reactive Hyperemia Index (RHI) measures Endothelial function and is assessed by digital pulse amplitude tonometry and it is a sensitive indicator of endothelial function. RHI is a calculated as a ratio between tested versus contralateral finger dilatation, thus there is no unit measure.|Post-transfusion|||LnRHI||Standard Error|Mean
683309|NCT01529502|Primary|Systolic Pulmonary Artery Pressure|Pulmonary vasoconstriction was measured by estimation of Systolic Pulmonary Artery Pressure in millimeter of mercury (mmHg) by trans-thoracic echocardiography|Post-transfusion|"In the fresh blood only 9 volunteers estimation of Systolic Pulmonary Artery Pressure was successfully studied by trans-thoracic echocardiography. In the old blood only 11 volunteers and In the old blood + Inhaled Nitric Oxide only 12 volunteers estimation of Systolic Pulmonary Artery Pressure was successfully evaluated."||mmHg||Standard Error|Mean
683310|NCT01529450|Secondary|Molecular Markers Associated With Clinical Response|Following consent, historical biopsy samples were analyzed for molecular markers associated with clinical response. Tumors were analyzed and present of Smooth mutation (SMO [genetic changes which influence Ki 67 and Gli levels]). was determined. The number of participants with and without SMO were reported by clinical outcome (SD = stable disease; PD = progressive disease).|Assessed on day 1|Participants with tissue available for screening were analyzed.||participants|||Number
683311|NCT01529450|Primary|Progression Free Survival (PFS) of All Participants||End of treatment or at time of disease progression (up to 58 weeks)|Progression is defined using RECIST version 1.0 as a 20% increase in the sum of the longest diameter of target lesions, or a measureable increase in a non-target lesion or the appearance of new lesion.||weeks||95% Confidence Interval|Median
683323|NCT01529268|Secondary|Change in Pediatric Quality of Life Inventory (PedsQL) Score|Pediatric Quality of Life Inventory (PedsQL) version 4.0 is completed by both the child and parent/caregiver, and is composed of 23 items comprising 4 dimensions: Physical Functioning, Emotional Functioning, Social Functioning, and School Functioning. Scores are transformed on a scale from 0 to 100, with higher scores indicating better health-related quality of life. Physical Health Summary Score =Physical Functioning Scale Score. Psychosocial Health Summary Score = Sum of items over the number of items answered in the Emotional, Social, and School Functioning Scales.|52 weeks|||units on a scale||Standard Deviation|Mean
683324|NCT01529268|Secondary|Change in Diastolic Blood Pressure||52 weeks|||mmHg||Standard Deviation|Mean
683325|NCT01529268|Secondary|Change in Systolic Blood Pressure||52 weeks|||mmHg||Standard Deviation|Mean
683326|NCT01529268|Secondary|Change in HOMA-IR|(Glucose (mmol/L) x insulin (pmol/L))/22.5|52 weeks|||(10E-15 mol^2)/L^2||Standard Deviation|Mean
683327|NCT01529268|Secondary|Change in Fasting Insulin||52 weeks|||μU/mL||Standard Deviation|Mean
683328|NCT01529268|Secondary|Change in Fasting Serum Glucose||52 weeks|||mg/dL||Standard Deviation|Mean
683329|NCT01529268|Secondary|Change in Waist Circumference||52 weeks|||cm||Standard Deviation|Mean
683330|NCT01529268|Secondary|Change in Body-mass Index Z-score||52 weeks|||SD||Standard Deviation|Mean
683331|NCT01529268|Secondary|Change in Body-mass Index||52 weeks|||kg/m^2||Standard Deviation|Mean
683332|NCT01529268|Secondary|Change in Weight (kg)||52 weeks|Smaller number of patients analyzed due to missing 52-week weight measurement.||kg||Standard Deviation|Mean
683333|NCT01529268|Secondary|Change in Serum Aminotransferase and Gamma-glutamyl Transpeptidase||52 weeks|The smaller number of participants analyzed is due to missing 52-week laboratory data.||U/L||Standard Deviation|Mean
683334|NCT01529268|Secondary|Resolution of NASH|Patients with a change from a histological diagnosis of definite NASH or indeterminate for NASH to not NASH at end of treatment|52 weeks|Analysis was limited to patients with a diagnosis of definite NASH at baseline.||participants|||Number
683335|NCT01529268|Secondary|Fibrosis: Change in Stage|Change from baseline in fibrosis stage. The amount of fibrosis is based on central pathologist grading of liver biopsies: 0=none; 1a=mild, zone 3 perisinusoidal, 1b=moderate, zone 3, perisinusoidal, 1c=portal/periportal only, 2=zone 3 and periportal, any combination, 3=bridging, 4=cirrhosis. Fibrosis stages 1a, 1b, 1c recoded as 1, so the possible range of values for fibrosis stage was 0-4. Change in fibrosis stage has a possible range of -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome (no improvement).|52 weeks|The smaller number of participants analyzed is due to missing 52-week biopsies (complete case analysis).||units on a scale||Standard Deviation|Mean
683336|NCT01529268|Secondary|Fibrosis: Patients With Improvement|Improvement in fibrosis stage defined as any decrease in fibrosis stage comparing 52-week biopsy to baseline.|52 weeks|Analysis based on intention to treat; patients with missing 52-week biopsy were imputed as lack of improvement.||participants|||Number
683337|NCT01529268|Secondary|Portal Inflammation: Change in Score|Change from baseline in portal inflammation score. The amount of portal inflammation is based on central pathologist grading of liver biopsies: 0=none; 1=mild, 2=more than mild. Change in portal inflammation score has a possible range of -2 to +2, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome (no improvement).|52 weeks|The smaller number of participants analyzed is due to missing 52-week biopsies (complete case analysis).||units on a scale||Standard Deviation|Mean
683338|NCT01529268|Secondary|Portal Inflammation: Patients With Improvement|Improvement in portal inflammation defined as any decrease in portal inflammation score comparing 52-week biopsy to baseline.|52 weeks|Analysis based on intention to treat; patients with missing 52-week biopsy were imputed as lack of improvement.||participants|||Number
683339|NCT01529268|Secondary|Hepatocellular Ballooning: Change in Score|Change from baseline in hepatocellular ballooning score. The amount of hepatocellular ballooning is based on central pathologist grading of liver biopsies: 0=none; 1=few ballooned hepatocytes, 2=many ballooned hepatocytes. Change in hepatocellular ballooning score has a possible range of -2 to +2, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome (no improvement).|52 weeks|The smaller number of participants analyzed is due to missing 52-week biopsies (complete case analysis).||units on a scale||Standard Deviation|Mean
683340|NCT01529268|Secondary|Hepatocellular Ballooning: Patients With Improvement|Improvement in hepatocellular ballooning defined as any decrease in hepatocellular ballooning score comparing 52-week biopsy to baseline.|52 weeks|Analysis based on intention to treat; patients with missing 52-week biopsy were imputed as lack of improvement.||participants|||Number
683341|NCT01529268|Secondary|Lobular Inflammation: Change in Score|Change from baseline in lobular inflammation score. The amount of lobular inflammation is based on central pathologist grading of liver biopsies, and combines mononuclear, fat granulomas, and polymorphonuclear (pmn) foci: 0=none; 1=<2 under 20x magnification, 2=2-4 under 20x magnification, 3=>4 under 20x magnification. Change in lobular inflammation score has a possible range of -3 to +3, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome (no improvement).|52 weeks|The smaller number of participants analyzed is due to missing 52-week biopsies (complete case analysis).||units on a scale||Standard Deviation|Mean
683342|NCT01529268|Secondary|Lobular Inflammation: Patients With Improvement|Improvement in lobular inflammation defined as any decrease in lobular inflammation grade comparing 52-week biopsy to baseline.|52 weeks|Analysis based on intention to treat; patients with missing 52-week biopsy were imputed as lack of improvement.||participants|||Number
683343|NCT01529268|Secondary|Steatosis: Change in Score|Change from baseline in steatosis score. Steatosis score is based on central pathologist grading of liver biopsies: 0=<5% steatosis; 1=5-33% steatosis, 2=34-66% steatosis, 3=>66% steatosis. Change in steatosis score has a possible range of -3 to +3, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome (no improvement).|52 weeks|The smaller number of participants analyzed is due to missing 52-week biopsies (complete case analysis).||units on a scale||Standard Deviation|Mean
683344|NCT01529268|Secondary|Steatosis: Patients With Improvement|Improvement in steatosis defined as any decrease in steatosis grade comparing 52-week biopsy to baseline.|52 weeks|Analysis based on intention to treat; patients with missing 52-week biopsy were imputed as lack of improvement.||participants|||Number
683345|NCT01529268|Secondary|Change in Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS)|Change from baseline in the NAFLD Activity Score (NAS), which is a composite score equal to the sum of the steatosis grade (0-3), lobular inflammation grade (0-3), and hepatocellular ballooning grade (0-2), from centralized pathologist scoring of liver biopsies. The overall scale of the NAS is 0-8, with higher scores indicating more severe disease. The outcome measure, change from baseline in NAFLD Activity Score (NAS), has a possible range from -8 to +8, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome. Components of the NAS are scored as follows: Steatosis grade 0=<5% steatosis, 1=5-33% steatosis, 2=34-66% steatosis, 3=>66% steatosis. Lobular inflammation grade=amount of lobular inflammation (combines mononuclear, fat granulomas, and polymorphonuclear (pmn) foci): 0=0, 1=<2 under 20x magnification, 2=2-4 under 20x magnification, 3=>4 under 20x magnification. Hepatocellular ballooning 0=none, 1=mild, 2=more than mild.|52 weeks|The smaller number of participants analyzed is due to missing 52-week biopsies (complete case analysis).||units on a scale||Standard Deviation|Mean
683346|NCT01529268|Primary|Improvement in Nonalcoholic Fatty Liver Disease (NAFLD)|Centrally scored and masked assessment of histologic improvement in Nonalcholic Fatty Liver Disease (NAFLD) between the baseline liver biopsy and follow-up biopsy after 52 weeks of treatment, where improvement is defined as: (1) decrease in the NAFLD Activity Score (NAS) of 2 or more and (2) no worsening of fibrosis.|52 weeks|Analysis based on intention to treat; patients with missing 52-week biopsy were imputed as lack of improvement.||participants|||Number
683347|NCT01529203|Secondary|Related Adverse Event|Number of subjects reporting related adverse events|Month 6|||participants|||Number
683348|NCT01529203|Secondary|Global Aesthetic Improvement From Baseline|"The scale responses are: -1 indicating worse, 0 indicating no change, 1 indicating improved, 2 indicating much improved and 3 indicating very much improved."|Week 3|||percentage of total subjects|||Number
683349|NCT01529203|Primary|Subject Satisfaction for the Full Face|based on the subject's satisfaction questionnaire|Month 6|only the 56 subjects who had provided answers in the subject's satisfaction questionnaire were included in the analysis||percentage of total subjects|||Number
683350|NCT01529112|Secondary|Pharmacokinetic (PK) Profile of Lenvatinib in Subjects With Non Small Cell Lung Cancer (NSCLC)|Blood samples were collected for lenvatinib PK analysis. Lenvatinib concentrations from sparse PK sampling were measured. The data is presented as mean nanograms per milliliter +/- Standard deviation of lenvatinib serum concentration.|Cycle 1/Day 1 (between 0.5 and 4 hours postdose and 6 and 10 hours postdose), Cycle 1/Day 15 (predose, between 0.5 and 4 hours postdose, and 6 and 10 hours postdose), and Day 1 of Cycles 2 though 4 (predose and between 2 and 12 hours postdose)|The analysis was performed using the pharmacokinetic (PK) analysis set defined as all subjects who received at least one dose of study drug and had evaluable PK data.||nanograms per milliliter||Standard Deviation|Mean
683351|NCT01529112|Secondary|The Percentage of Participants With The European Organization for Research and Treatment of Cancer (EORTC) Module QLQ-LC13 (Lung Cancer 13) Symptom Scores Achieving Clinically Significant Deterioration on QOL|The EORTC module QLQ-LC13 symptom score was a self-reporting cancer-specific questionnaire composed of 13 questions incorporated into 1 multi-item scale designed to evaluate dyspnea and a series of single items assessing different types of pain, as well as, cough, hemoptysis, dysphagia, sore mouth, alopecia, and peripheral neuropathy. For each domain and item, a linear transformation was applied to standardize the raw score to a range from 0 to 100, with 100 representing the best possible function/QOL, and highest burden of symptoms for symptom domains and single items. The data is presented as percentage of participants with EORTC module QLQ-C13 symptom score achieving clinically significant deterioration on QOL. Participants were considered as deteriorated for a given symptom if the change in score from Baseline was 10 points or higher at any time point after Baseline. The data presented is based on the data cut-off date of 21 January 2014 while the study is still ongoing.|Baseline (Day 1 of Cycle 1 (prior to treatment in Cycle 1)), every 4 weeks during treatment, and 4 weeks after completing treatment or up to approximately 2 years (data cut-off date of 21 January 2014)|The analysis was performed using the Intent-to-Treat Population, defined as all randomized subjects.||Percentage of participants|||Number
683352|NCT01529112|Secondary|The Percentage of Participants With The European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Symptom Scores Achieving Clinically Significant Deterioration on Quality of Life (QOL)|The EORTC QLQ-C30 symptom score, a cancer specific self-reporting questionnaire was composed of 9-symptom scales assessing fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties. All of the multi-item scales and single-item measures ranged in score from 0 to 100. For each domain and item, a linear transformation was applied to standardize the raw score to a range from 0 to 100, with a higher scale score representing a higher response level/ high level of symptomatology / problems. The data is presented as percentage of participants with EORTC QLQ-C30 symptom score achieving clinically significant deterioration on QOL. Participants were considered as deteriorated for a given symptom if the change in score from Baseline was 10 points or higher at any time point after Baseline. The data presented is based on the data cut-off date of 21 January 2014 while the study is still ongoing.|Baseline (Day 1 of Cycle 1 (prior to treatment in Cycle 1)), every 4 weeks during treatment, and 4 weeks after completing treatment or up to approximately 2 years (data cut-off date of 21 January 2014)|The analysis was performed using the Intent-to-Treat Population, defined as all randomized subjects.||Percentage of participants|||Number
683353|NCT01529112|Secondary|Disease Control Rate (DCR)|The percentage of participants with CR, PR, or stable disease (SD) for greater than or equal to 12 weeks. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable disease was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on the study. The data presented is based on the data cut-off date of 21 January 2014 while the study is still ongoing.|From date of randomization (Day 1) until disease progression or death, development of unacceptable toxicity, withdrawal of consent, withdrawal by Investigator, or up to approximately 2 years (data cut-off date of 21 January 2014)|The analysis was performed using the Intent-to-Treat Population, defined as all randomized subjects.||Percentage of Participants||95% Confidence Interval|Number
683354|NCT01529112|Secondary|Response Duration (RD)|Response duration, defined as the time from the date of the first assessment demonstrating a CR or PR to the date of the first assessment demonstrating progressive disease or death, whichever occurred first. This is an investigator assessed outcome, measured using RECIST 1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Response duration was summarized by including only subjects with events. The data presented is based on the data cut-off date of 21 January 2014 while the study is still ongoing.|From date of randomization (Day 1) until disease progression or death, development of unacceptable toxicity, withdrawal of consent, withdrawal by Investigator, or up to approximately 2 years (data cut-off date of 21 January 2014)|The analysis was performed using subjects with events.||Weeks||95% Confidence Interval|Median
683355|NCT01529112|Primary|Overall Survival (OS)|OS was defined as the time from the date of randomization until the date of death from any cause.|From date of randomization (Day 1) until occurrence of 90 deaths in the study (cut off date 26 November 2013), approximately 22 months|The analysis was performed using the Intent-to-Treat Population, defined as all randomized subjects.||weeks||95% Confidence Interval|Median
683356|NCT01529112|Secondary|Overall Response Rate (ORR)|ORR, defined as the percentage of participants who had best overall response (BOR) of complete response (CR) or partial response (PR) as determined by investigator using RECIST 1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR = CR + PR. The data presented is based on the data cut-off date of 21 January 2014 while the study is still ongoing.|From date of randomization (Day 1) until disease progression or death, development of unacceptable toxicity, withdrawal of consent, withdrawal by Investigator, or up to approximately 2 years (data cut-off date of 21 January 2014)|The analysis was performed using the Intent-to-Treat Population, defined as all randomized subjects.||Percentage of Participants||95% Confidence Interval|Number
683357|NCT01529112|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time from the date of the randomization until the date of first documented disease progression according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 or date of death from any cause (whichever occurred first), assessed based on investigator's assessment. Disease progression per RECIST v1.1 was defined as at least a 20% relative increase and 5 mm absolute increase in the sum of diameters of target lesions (taking as reference the smallest sum on study), recorded since the treatment started or the appearance of 1 or more new lesions. The data presented is based on the data cut-off date of 21 January 2014 while the study is still ongoing.|From date of randomization (Day 1) until date of first documentation of disease progression or death from any cause (whichever occurred first) or up to approximately 2 years (data cut-off date of 21 January 2014)|The analysis was performed using the Intent-to-Treat Population, defined as all randomized subjects.||weeks||95% Confidence Interval|Median
683358|NCT01529112|Secondary|1-year Survival Rate|Event-free survival rate was calculated using Kaplan Meier estimations. The percentage of participants with event free survival up to 1 year and the corresponding 95% confidence interval were estimated for each treatment group. The data presented is based on the data cut-off date of 26 November 2013 while the study is still ongoing.|From date of randomization (Day 1) up to 1 year|The analysis was performed using the Intent-to-Treat Population, defined as all randomized subjects.||Percentage of Participants||95% Confidence Interval|Number
683359|NCT01529112|Secondary|6-Month Survival Rate|Event-free survival rate was calculated using Kaplan Meier estimations. The percentage of participants with event free survival up to 6 months and the corresponding 95% confidence interval were estimated for each treatment group. The data presented is based on the data cut-off date of 26 November 2013 while the study is still ongoing.|From date of randomization (Day 1) up to 6 months|The analysis was performed using the Intent-to-Treat Population, defined as all randomized subjects.||Percentage of Participants||95% Confidence Interval|Number
683360|NCT01529112|Secondary|Number of Participants With Treatment Emergent Non-serious Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs)|An AE was defined as any untoward medical occurrence in a clinical investigation participant administered with an investigational product. A SAE was defined as any untoward medical occurrence that at any dose; resulted in death, was life-threatening (i.e., the subject was at a risk of death at the time of the event; this did not include an event that hypothetically might have caused death if it had been more severe), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, or was a congenital abnormality/birth defect. In this study, treatment emergent adverse events (TEAEs) (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.|For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)|Safety was analyzed in Safety Analysis Set defined as all subjects enrolled and randomized to treatment in study, except for those who (i) dropped out prior to receiving any study drug, or (ii) were without any safety assessment following the first dose of study drug.||Participants|||Number
683361|NCT01528969|Secondary|The Changes in the Counts of the 14 Other Bacterial Species|The bacterial species were measured from stimulated saliva at the beginning and after the intervention|5 weeks||||||
683362|NCT01528969|Primary|MS Counts of Stimulated Saliva|The MS counts were measured at the beginning and in the end of the 5 weeks intervention|5 weeks|||MS counts log CFU/ml||Standard Deviation|Mean
683363|NCT01528891|Primary|Diastolic Blood Pressure (DBP)|"mmHg
Three subjects with missing data points for DBP were necessarily eliminated from repeated measures analysis."|Diastolic blood pressure (DBP) was measured immediately prior to study drug injection (baseline) and every minute thereafter for 5 minutes. DBP was also measured upon the patient's arrival to the Post-Anesthesia Care Unit (PACU).|Diastolic blood pressure values were compared between groups at each time point and within groups over time.||mmHg||Standard Deviation|Mean
683441|NCT01528332|Secondary|Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) at Visit 5|The RMDQ is a 24 list of yes/no questions about the effects of back pain on the participants daily activities. Each positive answer is a point; maximum total score = 24.|Baseline (days -7 to +1) to Treatment 5 (day +14)||||||
683364|NCT01528891|Primary|Systolic Blood Pressure (SBP)|"mmHg
Two subjects with missing data points for SBP were necessarily eliminated from repeated measures analysis."|Systolic blood pressure (SBP) was measured immediately prior to study drug injection (baseline) and every minute thereafter for 5 minutes. SBP was also measured upon the patient's arrival to the Post-Anesthesia Care Unit (PACU).|Systolic blood pressure values were compared between groups at each time point and within groups over time.||mmHg||Standard Deviation|Mean
683365|NCT01528891|Secondary|Incidence of Emergence Agitation (EA)|Using a Pediatric Anesthesia Emergence Delirium (PAED) score, emergence agitation scores will be recorded. The PAED score consists of 5 different criteria which are assessed from 0 to 4 once the patient has woken up. These criteria are then totaled; the total may range from 0 to 20, where 0 represents no emergence agitation and 20 represents maximal agitation. For this study, patients with a maximum PAED score of >10 and >12 were considered to be agitated.|The highest PAED score for each patient within the first 30 minutes after waking up was recorded.|There were 2 patients in the Dexmedetomidine group and 9 patients in the placebo group who were excluded from analysis of emergence agitation. These patients were excluded because they received medications that were not a part of the anesthetic protocol and could affect their PAED score.||percentage of patients with EA|||Number
683366|NCT01528891|Primary|Heart Rate (HR)|beats per minute (bpm)|Heart rate was measured immediately prior to study drug injection (baseline) and every minute thereafter for 5 minutes. Heart rate was also measured upon the patient's arrival to the Post-Anesthesia Care Unit (PACU).|Heart rate values were compared between groups at each time point and within groups over time.||bpm||Standard Deviation|Mean
683367|NCT01528735|Secondary|Predose Measured Concentration of RBV|Predose measured concentration of ribavirin (RBV) in plasma before the morning dose of the Nth day (Cpre,N) and at steady state (Cpre,ss).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h and 11h 50min after drug administration on days 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
683368|NCT01528735|Secondary|Mean Residence Time (MRTpo,ss) of RBV|"Mean residence time of ribavirin (RBV) in the body after oral administration at steady state (MRTpo,ss).
This endpoint was not analysed as the parameter was not calculable for all patients in both treatment groups."|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h and 11h 50min after drug administration on day 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||||
683369|NCT01528735|Secondary|Cmax Accumulation Ratio (RA,Cmax,57) of RBV|Accumulation ratio of ribavirin (RBV) in plasma after the administration of the 57th day over a uniform dosing interval tau, expressed as a ratio of Cmax after the morning dose of the 57th day and after the first dose (RA,Cmax,57).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h and 11h 50min after drug administration on days 1 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data. Analysis includes patients with available data for this parameter.||Ratio||Geometric Coefficient of Variation|Geometric Mean
683370|NCT01528735|Secondary|AUC Accumulation Ratio of RBV|Accumulation ratio of ribavirin (RBV) in plasma after the administration of the 57th day over a uniform dosing interval tau, expressed as a ratio of AUC after the morning dose of the 57th day and after the first dose (RA,AUC,57).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h and 11h 50min after drug administration on days 1 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data. Analysis includes patients with available data for this parameter.||Ratio||Geometric Coefficient of Variation|Geometric Mean
683371|NCT01528735|Secondary|Predose Measured Concentration of CD 6168-AG|Predose measured concentration of CD 6168-AG (a metabolite of Deleobuvir) in plasma before the morning dose of the Nth day (Cpre,N) and at steady state (Cpre,ss). AG=acylglucuronide.|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
683372|NCT01528735|Secondary|Mean Residence Time (MRTpo,ss) of CD 6168-AG|"Mean residence time of CD 6168-AG (a metabolite of Deleobuvir) in the body after oral administration at steady state (MRTpo,ss). AG=acylglucuronide.
This endpoint was not analysed as the parameter was not calculable for all patients in both treatment groups."|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on day 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||||
683373|NCT01528735|Secondary|AUC Accumulation Ratio of CD 6168-AG|Accumulation ratio of CD 6168-AG (a metabolite of Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of AUC after the morning dose of the Nth day and after the first dose (RA,AUC,N), and ratio of the AUC,ss of CD 6168-AG versus AUC,ss of Deleobuvir (RA,AUC,Met,ss). AG=acylglucuronide.|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||Ratio||Geometric Coefficient of Variation|Geometric Mean
683384|NCT01528735|Secondary|Apparent Clearance (CL/F,ss) of Faldaprevir|Apparent clearance of Faldaprevir (BI 201335 ZW) in plasma following extravascular administration on the 57th day (CL/F,ss).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on day 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data. Analysis includes patients with available data for this parameter.||mL/min||Geometric Coefficient of Variation|Geometric Mean
683374|NCT01528735|Secondary|Cmax Accumulation Ratio of CD 6168-AG|Accumulation ratio of CD 6168-AG (a metabolite of Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of Cmax after the morning dose of the Nth day and after the first dose (RA,Cmax,N), and ratio of the Cmax,ss of CD 6168-AG versus Cmax,ss of Deleobuvir (RA,Cmax,Met,ss). AG=acylglucuronide.|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||Ratio||Geometric Coefficient of Variation|Geometric Mean
683375|NCT01528735|Secondary|Predose Measured Concentration of CD 6168|Predose measured concentration of CD 6168 (a metabolite of Deleobuvir) in plasma before the morning dose of the Nth day (Cpre,N) and at steady state (Cpre,ss).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
683376|NCT01528735|Secondary|Mean Residence Time (MRTpo,ss) of CD 6168|"Mean residence time of CD 6168 (a metabolite of Deleobuvir) in the body after oral administration at steady state (MRTpo,ss).
This endpoint was not analysed as the parameter was not calculable for all patients in both treatment groups."|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on day 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||||
683377|NCT01528735|Secondary|AUC Accumulation Ratio of CD 6168|Accumulation ratio of CD 6168 (a metabolite of Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of AUC after the morning dose of the Nth day and after the first dose (RA,AUC,N), and ratio of the AUC,ss of CD 6168 versus AUC,ss of Deleobuvir (RA,AUC,Met,ss).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||Ratio||Geometric Coefficient of Variation|Geometric Mean
683378|NCT01528735|Secondary|Cmax Accumulation Ratio of CD 6168|Accumulation ratio of CD 6168 (a metabolite of Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of Cmax after the morning dose of the Nth day and after the first dose (RA,Cmax,N), and ratio of the Cmax,ss of CD 6168 versus Cmax,ss of Deleobuvir (RA,Cmax,Met,ss).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||Ratio||Geometric Coefficient of Variation|Geometric Mean
683379|NCT01528735|Secondary|Predose Measured Concentration of BI 208333|Predose measured concentration of BI 208333 (a metabolite of Deleobuvir) in plasma before the morning dose of the Nth day (Cpre,N) and at steady state (Cpre,ss).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
683380|NCT01528735|Secondary|Mean Residence Time (MRTpo,ss) of BI 208333|"Mean residence time of BI 208333 (a metabolite of Deleobuvir) in the body after oral administration at steady state (MRTpo,ss).
This endpoint was not analysed as the parameter was not calculable for all patients in both treatment groups."|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on day 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||||
683381|NCT01528735|Secondary|AUC Accumulation Ratio of BI 208333|Accumulation ratio of BI 208333 (a metabolite of Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of AUC after the morning dose of the Nth day and after the first dose (RA,AUC,N), and ratio of the AUC,ss of BI 208333 versus AUC,ss of Deleobuvir (RA,AUC,Met,ss).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||Ratio||Geometric Coefficient of Variation|Geometric Mean
683382|NCT01528735|Secondary|Cmax Accumulation Ratio of BI 208333|Accumulation ratio of BI 208333 (a metabolite of Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of Cmax after the morning dose of the Nth day and after the first dose (RA,Cmax,N), and ratio of the Cmax,ss of BI 208333 versus Cmax,ss of Deleobuvir (RA,Cmax,Met,ss).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||Ratio||Geometric Coefficient of Variation|Geometric Mean
683383|NCT01528735|Secondary|Predose Measured Concentration of Faldaprevir|Predose measured concentration of Faldaprevir (BI 201335 ZW) in plasma before the morning dose of the Nth day (Cpre,N) and at steady state (Cpre,ss).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
683435|NCT01528332|Secondary|Vital Sign Parameters|Vital signs (blood pressure and pulse)will be assessed at each visit and changes from baseline compared between the treatment groups|Baseline (days -7 to -1) to Follow up (up to day +42)||||||
683385|NCT01528735|Secondary|Mean Residence Time (MRTpo,ss) of Faldaprevir|"Mean residence time of Faldaprevir (BI 201335 ZW) in the body after oral administration at steady state (MRTpo,ss).
This endpoint was not analysed as the parameter was not calculable for all patients in both treatment groups."|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on day 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||||
683386|NCT01528735|Secondary|AUC Accumulation Ratio of Faldaprevir|Accumulation ratio of Faldaprevir (BI 201335 ZW) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of AUC after the morning dose of the Nth day and after the first dose (RA,AUC,N).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||Ratio||Geometric Coefficient of Variation|Geometric Mean
683387|NCT01528735|Secondary|Cmax Accumulation Ratio (RA,Cmax,N) of Faldaprevir|Accumulation ratio of Faldaprevir (BI 201335 ZW) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of Cmax after the morning dose of the Nth day and after the first dose (RA,Cmax,N).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||Ratio||Geometric Coefficient of Variation|Geometric Mean
683388|NCT01528735|Secondary|Predose Measured Concentration of Deleobuvir|Predose measured concentration of BI 207127 (Deleobuvir) in plasma before the morning dose of the Nth day (Cpre,N) and at steady state (Cpre,ss).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 11 and 57|Pharmacokinetic (PK) analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
683389|NCT01528735|Secondary|Apparent Clearance (CL/F,ss) of Deleobuvir|Apparent clearance of BI 207127 (Deleobuvir) in plasma following extravascular administration on the 57th day (CL/F,ss).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on day 57|Pharmacokinetic (PK) analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data. Analysis includes patients with available data for this parameter.||Litres per hour||Geometric Coefficient of Variation|Geometric Mean
683390|NCT01528735|Secondary|Mean Residence Time (MRTpo,ss) of Deleobuvir|Mean residence time of BI 207127 (Deleobuvir) in the body after oral administration at steady state (MRTpo,ss).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on day 57|Pharmacokinetic (PK) analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data. Analysis includes patients with available data for this parameter.||hours||Geometric Coefficient of Variation|Geometric Mean
683391|NCT01528735|Secondary|AUC Accumulation Ratio of Deleobuvir|Accumulation ratio of BI 207127 (Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of AUC after the morning dose of the Nth day and after the first dose (RA,AUC,N), and ratio of the AUC,ss of Deleobuvir versus itself (RA,AUC,Met,ss).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|Pharmacokinetic (PK) analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||Ratio||Geometric Coefficient of Variation|Geometric Mean
683392|NCT01528735|Secondary|Cmax Accumulation Ratio (RA,Cmax,N) of Deleobuvir|Accumulation ratio of BI 207127 (Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of Cmax after the morning dose of the Nth day and after the first dose (RA,Cmax,N), and ratio of the Cmax,ss of Deleobuvir versus itself (RA,Cmax,Met,ss).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|Pharmacokinetic (PK) analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||Ratio||Geometric Coefficient of Variation|Geometric Mean
683393|NCT01528735|Secondary|Area Under the Curve (AUC) of RBV|Area under the concentration time curve (AUC) of ribavirin (RBV) in plasma after the morning dose on the Nth day (AUCτ,N) and at steady state (AUCτ,ss), over a uniform dosing interval τ.|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h and 11h 50min after drug administration on days 1 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
683394|NCT01528735|Secondary|Time From Last Dosing to the Maximum Concentration (Tmax) of RBV|Time from last dosing to the maximum concentration of ribavirin (RBV) in plasma after the morning dose of Nth day (Tmax,N).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h and 11h 50min after drug administration on days 1 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||hours||Full Range|Median
683395|NCT01528735|Secondary|Maximum Measured Concentration (Cmax) of RBV|Maximum measured concentration of ribavirin (RBV) in plasma following the morning dose of Nth day (Cmax,N).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h and 11h 50min after drug administration on days 1 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
683396|NCT01528735|Secondary|Area Under the Curve (AUC) of CD 6168-AG|Area under the concentration time curve (AUC) of the analyte in plasma after the morning dose on the Nth day (AUCτ,N) and at steady state (AUCτ,ss), over a uniform dosing interval τ. AG=acylglucuronide.|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
683397|NCT01528735|Secondary|Time From Last Dosing to the Maximum Concentration (Tmax) of CD 6168-AG|Time from last dosing to the maximum concentration of CD 6168-AG (a metabolite of Deleobuvir) in plasma after the morning dose of Nth day (Tmax,N). AG=acylglucuronide.|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||hours||Full Range|Median
683398|NCT01528735|Secondary|Maximum Measured Concentration (Cmax) of CD 6168-AG|Maximum measured concentration of CD 6168-AG (a metabolite of Deleobuvir) in plasma following the morning dose of Nth day (Cmax,N). AG=acylglucuronide.|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
683399|NCT01528735|Secondary|Area Under the Curve (AUC) of CD 6168|Area under the concentration time curve (AUC) of the analyte in plasma after the morning dose on the Nth day (AUCτ,N) and at steady state (AUCτ,ss), over a uniform dosing interval τ.|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
683400|NCT01528735|Secondary|Time From Last Dosing to the Maximum Concentration (Tmax) of CD 6168|Time from last dosing to the maximum concentration of CD 6168 (a metabolite of Deleobuvir) in plasma after the morning dose of Nth day (Tmax,N).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||hours||Full Range|Median
683401|NCT01528735|Secondary|Maximum Measured Concentration (Cmax) of CD 6168|Maximum measured concentration of CD 6168 (a metabolite of Deleobuvir) in plasma following the morning dose of Nth day (Cmax,N).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
683402|NCT01528735|Secondary|Area Under the Curve (AUC) of BI 208333|Area under the concentration time curve (AUC) of the analyte in plasma after the morning dose on the Nth day (AUCτ,N) and at steady state (AUCτ,ss), over a uniform dosing interval τ.|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
683403|NCT01528735|Secondary|Time From Last Dosing to the Maximum Concentration (Tmax) of BI 208333|Time from last dosing to the maximum concentration of BI 208333 (a metabolite of Deleobuvir) in plasma after the morning dose of Nth day (Tmax,N).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||hours||Full Range|Median
683404|NCT01528735|Secondary|Maximum Measured Concentration (Cmax) of BI 208333|Maximum measured concentration of BI 208333 (a metabolite of Deleobuvir) in plasma following the morning dose of Nth day (Cmax,N).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
683405|NCT01528735|Secondary|Area Under the Curve (AUC) of Faldaprevir|Area under the concentration time curve (AUC) of the analyte in plasma after the morning dose on the Nth day (AUCτ,N) and at steady state (AUCτ,ss), over a uniform dosing interval τ.|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
683406|NCT01528735|Secondary|Time From Last Dosing to the Maximum Concentration (Tmax) of Faldaprevir|Time from last dosing to the maximum concentration of Faldaprevir (BI 201335 ZW) in plasma after the morning dose of Nth day (Tmax,N).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||hours||Full Range|Median
683436|NCT01528332|Secondary|Frequency, Severity, Nature and Duration of Adverse Events During the Whole Duration of the Study|Adverse events will be assessed using descriptive statistical methods and compared between treatment arms.|Baseline (days -7 to -1) to Follow up (up to day +42)||||||
683437|NCT01528332|Secondary|Change From Treatment in RMDQ at Follow up||Treatment (days +1 to +14) to Follow up (up to day +42)||||||
683407|NCT01528735|Secondary|Maximum Measured Concentration (Cmax) of Faldaprevir|Maximum measured concentration of Faldaprevir (BI 201335 ZW) in plasma following the morning dose of Nth day (Cmax,N).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
683408|NCT01528735|Secondary|Area Under the Curve (AUC) of Deleobuvir|Area under the concentration time curve (AUC) of the analyte in plasma after the morning dose on the Nth day (AUCτ,N) and at steady state (AUCτ,ss), over a uniform dosing interval τ.|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
683409|NCT01528735|Secondary|Time From Last Dosing to the Maximum Concentration (Tmax) of Deleobuvir|Time from last dosing to the maximum concentration of Deleobuvir (BI 207127) in plasma after the morning dose of Nth day (Tmax,N).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||hours||Full Range|Median
683410|NCT01528735|Secondary|Maximum Measured Concentration (Cmax) of Deleobuvir|Maximum measured concentration of BI 207127 (Deleobuvir) in plasma following the morning dose of Nth day (Cmax,N).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|Pharmacokinetic (PK) analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
683411|NCT01528735|Secondary|Percentage of Participants With Virological Response at Week 8|Percentage of participants with plasma HCV RNA (hepatitis C virus ribonucleic acid ) level <25 IU/mL (undetected or detected) at week 8.|8 weeks|Full analysis set which included all patients with at least 1 on-treatment value of HCV RNA viral load||percentage of participants|||Number
683412|NCT01528735|Secondary|Percentage of Participants With Virological Response at Week 4|Percentage of participants with plasma HCV RNA (hepatitis C virus (HCV) ribonucleic acid (RNA)) level <25 IU/mL (undetected or detected) at week 4.|4 weeks|Full analysis set which included all patients with at least 1 on-treatment value of HCV RNA viral load||percentage of participants|||Number
683413|NCT01528735|Primary|Number of Patients With Drug-related Adverse Events|Number of patients with investigator defined drug-related Adverse Events|From first dose of study medication until 30 days after last dose of study medication, up to 199 days|Treated Set which included all patients who were dispensed study medication and were documented to have taken at least one dose of study medication.||participants|||Number
683414|NCT01528696|Secondary|Patient Report of Pain Severity and Control|Self Reported pain, on a scale from 1 to 10, where 1 is little pain and 10 is extreme pain|6 weeks|For logistical reasons, we were unable to gather outcome data either by the intended survey or by chart review. When it became clear that we would be unable to complete the study, recruitment was terminated and further attempts at data gathering were stopped. Therefore no outcome data could be analyzed.|||||
683415|NCT01528696|Secondary|Febrile Morbidity|Febrile morbidity would be measured by number of participants who experienced fever as a sign of infection at 2 days, and overall within 6 weeks of delivery.|2 days, 6 weeks|For logistical reasons, we were unable to gather outcome data either by the intended survey or by chart review. When it became clear that we would be unable to complete the study, recruitment was terminated and further attempts at data gathering were stopped. Therefore no outcome data could be analyzed.|||||
683416|NCT01528696|Primary|Number of Patients Who Experience One or More Wound Complications|A composite of cellulitis, wound dehiscence, seroma, hematoma, abscess, and fascial dehiscence from wound evaluation at any point within six weeks, as pulled from the medical record or based on patient report.|6 weeks|For logistical reasons, we were unable to gather outcome data either by the intended survey or by chart review. When it became clear that we would be unable to complete the study, recruitment was terminated and further attempts at data gathering were stopped. Therefore no outcome data could be analyzed.|||||
683417|NCT01528605|Secondary|Changes of Food Pattern From Baseline by Food Frequency Questionnaire During the Intervention||at baseline, 24, 48 weeks and 2 years||12/2015||||
683418|NCT01528605|Secondary|Changes From Baseline in Microperimetry (MP) During the Intervention|Microperimetry (MP) was measured by the MP1 Microperimeter|at baseline, 24, 48 weeks and 2 years during the intervention||12/2015||||
683419|NCT01528605|Secondary|Changes From Baseline in Multifocal Electroretinogram (mfERG) at 48 Weeks||at baseline and 48 weeks during the intervention||12/2015||||
683420|NCT01528605|Secondary|Changes of Flash Recovery Time (FRT) Measured by MDD-2 Macular Adaptometer|Flash recovery time (FRT) was measured by MDD-2 macular adaptometer at baseline, 24, 48 and 96 weeks|at baseline, 24, 48 weeks and 2 years during the intervention||12/2015||||
683421|NCT01528605|Secondary|Changes of Contrast Sensitivity (CSF) Measured by CSV-100 During the Intervention||at baseline, 24, 48 weeks and 2 years during the intervention||12/2015||||
683422|NCT01528605|Secondary|Changes of Best-spectacle Corrected Visual Acuity (BSCVA) During the Intervention|best-spectacle corrected visual acuity (BSCVA) measured by ETDRS chart at baseline and 24 weeks, 48 weeks, 2 years during the intervention. Four participants was excluded during the analysis since they did not finish the intervention. Three did not finish the follow up, while one died from breast cancer.|at baseline and 24 weeks, 48 weeks, 2 years during the intervention|||letters||Standard Deviation|Mean
683423|NCT01528605|Secondary|Changes of Serum Xanthophylls Concentrations During the Intervention|Changes of serum xanthophylls concentrations measured by high performance liquid chromatograph (HPLC)at baseline and 4, 12, 24 and 48 weeks during the first 48 weeks of intervention.Four participants was excluded during the analysis since they did not finish the intervention. Three did not finish the follow up, while one died from breast cancer.|at baseline and 4, 12, 24 and 48 weeks during the intervention|||μmol/L||Standard Deviation|Mean
683424|NCT01528605|Primary|Changes of Macular Pigment Optical Density (MPOD) During 48 Weeks and 2 Years|"Macular pigment is found in the center of the retina known as the macula and is made up of the carotenoids lutein and zeaxanthin. This pigment serves to protect the macula from harmful blue light. The MPOD ranges from 0 to 1, with higher scores corresponding with greater density (protection). The autofluorescence picture of subject's macular was analyzed for MPOD values.
4 participants was excluded during the analysis since they did not finish the intervention. Three did not finish the follow up, while one died from breast cancer."|at baseline and 24 weeks, 48 weeks, 2 years during the intervention|||density units||Standard Deviation|Mean
683427|NCT01528345|Secondary|Time to Worsening of ECOG Performance Status|Eastern Cooperative Oncology Group (ECOG) Performance Status (scales and criteria used by doctors and researchers to assess how a patient's disease is progressing and assess how the disease affects the daily living abilities of the patient.)|Screening, Every 4 weeks during treatment period, and every 8 weeks during follow-up (approximately 9-12 months)|This outcome measure was not analyzed as the study was terminated before time to worsening ECOG performance could be analyzed.|||||
683428|NCT01528345|Secondary|Number of Participants With Adverse Events as a Measure of Safety|"The type, frequency and severity of adverse events, laboratory values, and Electrocardiograms (ECGs) experienced by patients will be assessed according to Common Terminology Criteria for Adverse Events.
The study enrollment was terminated early due to challenges in enrolling patients with FGF amplified status. See safety section for safety details."|Screening, Week 2, Week 4 and approximately every 4 weeks during treatment period (approximately 34 months)|Safety Set: Consisted of all patients who received at least one dose of any compound of the study treatment (dovitinib +fulvestrant or placebo+fulvestrant). Patients were analyzed according to the actual study treatment received. Actual treatment received was defined as the treatment the patient received at the first day of study medication.||Participants|||Number
683429|NCT01528345|Secondary|Overall Survival (OS) Using Kaplan- Meier Method|OS was defined as the time from the date of randomization to the date of death from any cause. If a patient is not known to have died at the date of analysis cut-off, the OS will be censored at the last date of contact.|From date of randomization to date of death from any cause whichever comes first, assessed up to 34 months|Full Analysis Set (FAS): Consisted of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment and stratum to which they were assigned at randomization.||Months||95% Confidence Interval|Median
683430|NCT01528345|Secondary|Duration of Response (DOR)|DOR was defined as time from the date of the first documented response (CR or PR) to the date of the first documented or death due to disease. If a patient does not have a progression event, DOR will be censored on the date of the last adequate tumor assessment.|From date of first documented efficacy response (CR or PR) to time of documented progression (PD) whichever comes first, assessed up to 24 months|This outcome measure was not analyzed as the study was terminated before duration of response could be analyzed.|||||
683431|NCT01528345|Secondary|Overall Response Rate (ORR)|ORR was defined as the percentage of patients with a best overall response of Complete Response (CR) or Partial Response (PR) as per RECIST v1.1. Responses include: Complete Response: Disappearance of all non-nodal target lesions; Partial Response: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters; Progressive Disease: At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline; Stable Disease: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD; Unknown (UNK) Progression has not been documented and one or more target lesions have not been assessed or have been assessed using a different method than baseline.|Every 8 weeks assessed up to 34 months|Full Analysis Set (FAS): Consisted of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment and stratum to which they were assigned at randomization.||Percentage of participants||95% Confidence Interval|Number
683432|NCT01528345|Primary|Progression Free Survival (PFS) Based on Local Investigator Assessment|PFS was defined as the time from the date of randomization to the date of the first radiologically documented disease progression or death due to any cause and was assessed based on RECIST v1.1. Responses include: Complete Response: Disappearance of all non-nodal target lesions; Partial Response: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters; Progressive Disease: At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline; Stable Disease: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD; Unknown (UNK) Progression has not been documented and one or more target lesions have not been assessed or have been assessed using a different method than baseline.|Every 8 weeks assessed up to 34 months|Full Analysis Set (FAS): Consisted of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment and stratum to which they wereassigned at randomization.||Months||95% Confidence Interval|Median
683433|NCT01528332|Secondary|Average Visual Analog Scale Pain Relief Over 5 Treatments|The average pain relief scored on a 10.0 cm VAS pain relief scale (endpoints 0 = no pain, 10 = no relief|5 treatments (days +1 to +14)||||||
683434|NCT01528332|Secondary|Changes From Baseline in Skin Condition|Skin condition (erythema and hyperpigmentation as measured with the MX-18) and appearance (recorded with Polaroid photos) will be assessed once each at baseline and follow up, and before and after each treatment. The changes from baseline will be analysed using descriptive statistics and the two treatment arms compared.|Baseline (days -7 to -1) to Follow up (up to day +42)||||||
683438|NCT01528332|Secondary|Change From Baseline in RMDQ at Follow up||Baseline (days -7 to +1) to Follow-up (up to day +42)||||||
683442|NCT01528332|Primary|Change From Baseline (Mean of Three Measurements at Screening, Prior to Treatment Visit 1 and Treatment Visit 1 Pretreatment) in the Average Visual Analog Scale (VAS) Pain Intensity Over the 5 Treatment Days|Pain intensity scored on a 10.0 cm VAS with the endpoints 0 = no pain; 10 = worst pain imaginable|Baseline (Visit 1/day -7, at home and Visit 2/day +1), Treatment (Visits 2-6 post treatment/days +1 to +14)|||cm||Standard Error|Mean
683443|NCT01528319|Secondary|Adverse Event Evaluation|To evaluate all undesirable events which occurred between the time of obtainment of consent and 24 weeks after surgery|Between the time of obtainment of consent and 24 weeks after surgery|||participants|||Number
683444|NCT01528319|Secondary|Number of Participants With Abnormal Changes in One or More Laboratory Tests|To evaluate changes over time in each laboratory test item from before surgery to 12 and 24 weeks after surgery regarding the presence or absence of abnormal changes, causal relationship with this product and causes for development|12 weeks and 24 weeks after surgery|||participants|||Number
683445|NCT01528319|Secondary|Clinical Function Evaluation|"To evaluate the JSS-SIS score and Rowe score at 24 weeks after surgery
JSS-SIS Score (subscales are summed, higher values represent a better outcome):
Pain (0 to 20)
Function (0 to 20)
Range of Motion (0 to 20)
Evaluation of X-ray findings (0 to 10)
Stability (0 to 30)
Rowe Score (subscales are summed, higher values represent a better outcome):
Stability (0 to 50)
Motion (0 to 20)
Function (0 to 30)"|24 weeks|||units on a scale||Standard Deviation|Mean
683446|NCT01528319|Secondary|Procedure Success|The rate of successful cases when procedure success was defined as “The anchors can be inserted into the burr holes without breakage and the glenohumeral ligament labral complex can be sutured without tear of the sutures”|12 weeks|||participants|||Number
683447|NCT01528319|Primary|Clinical Function Evaluation|"To evaluate the Japan Shoulder Society Shoulder Instability Score (JSS-SIS) and Rowe Score at 12 weeks after surgery
JSS-SIS Score (subscales are summed, higher values represent a better outcome):
Pain (0 to 20)
Function (0 to 20)
Range of Motion (0 to 20)
Evaluation of X-ray findings (0 to 10)
Stability (0 to 30)
Rowe Score (subscales are summed, higher values represent a better outcome):
Stability (0 to 50)
Motion (0 to 20)
Function (0 to 30)"|12 weeks|||units on a scale||Standard Deviation|Mean
683448|NCT01528319|Primary|Surgery Success|The rate of successful cases when surgery success is defined as “Procedure success is confirmed, the anchors are confirmed to be in the burr holes by the MRI examination, the glenohumeral ligament labral complex is maintained at the anterior edge of the glenoid cavity at 12 weeks after surgery, and there is no need of retreatment”|12 weeks after surgery|||participants|||Number
683449|NCT01528293|Secondary|Degree of Take|Degree of split thickness skin graft taken or bioengineered alternative tissue induced wound shrinkage after 6 weeks of ActiV.A.C. System + Compression therapy versus Compression therapy alone in patients with chronic venous ulcerations.|6 Weeks|Enrollment was insufficient to support statistical analyses. Three subjects were screened and only one completed the study.|||||
683450|NCT01528293|Secondary|Quality of Life|Quality of life between ActiV.A.C. System + Compression therapy versus Compression therapy alone in patients with chronic venous ulcerations.|9 weeks|Enrollment was insufficient to support statistical analyses. Three subjects were screened and only one completed the study.|||||
683451|NCT01528293|Secondary|Compare the Time to Wound Bed Preparation, Quality of Life, Degree of Split Thickness Skin Graft/Bio-engineered Alternative Tissue Take|-Compare the time to wound bed preparation between the ActiV.A.C. System + Compression therapy versus Compression therapy alone in patients with chronic venous ulcerations.|9 weeks|Enrollment was insufficient to support statistical analyses. Three subjects were screened and only one completed the study.|||||
683452|NCT01528293|Primary|Compare Wound Healing|Wound healing between the ActiV.A.C. System + Compression therapy versus Compression therapy alone in patients with chronic venous ulcerations.|6 weeks|Enrollment was insufficient to support statistical analyses. Three subjects were screened and only one completed the study.|||||
683453|NCT01528215|Primary|Marginal Bone Level|Marginal bone level will be determined from radiographs and expressed as the distance from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant. Marginal bone level expressed in millimeters at the 12 months follow-up visit will be compared to values obtained at delivery of permanent restoration i.e. loading (baseline). Positive value denotes gain of bone. Negative value denotes loss of bone.|12 months after implant loading|||Millimeter|Implants|Standard Deviation|Mean
683454|NCT01528150|Primary|Freedom From RA and RV Lead-related Complications|Safety of the Accent MRI™ system with the Tendril MRI™ lead will be evaluated in terms of freedom from Right Atrial (RA) and Right Ventricular (RV) lead-related complications for the acute (implant to 2 month visit) and chronic (2 month visit through the 12 month visit) timeframes.|up to 12 months post-implant|A total of 464 patients were implanted. 463 patients (99.78%) were implanted with Accent MRI™ systems with the Tendril MRI™ leads while the remaining 1 patient (0.22%) was implanted with a device that was not an Accent MRI™ system. This patient was excluded from all primary endpoint analyses.||percentage of participants||97.5% Confidence Interval|Number
683455|NCT01527942|Secondary|Response Rate - of 3=Excellent at Hour 24 Using 4-point Global Satisfaction With Regards to Overall Pain Management Rating Scale 0=Poor to 3= Excellent.|The 4-point patient global satisfaction of pain management scale is self-reported and scores range from 0=poor to 3=excellent. Response rate of 3=excellent at 24 hours after baseline.|24 hours after baseline|Study was terminated - data were determined to be unusable by IRB due to consent issues.|||||
683456|NCT01527942|Secondary|Change in Pain Intensity on the 10-point Pain Intensity Scale Between Baseline and 24 Hours|The 10-point Pain Intensity Scale is self-reported and scores range from 0=no pain to10=worst possible. Change = (24 hour score - baseline)|baseline and 24 hours|Study was terminated - data were determined to be unusable by IRB due to consent issues.|||||
683457|NCT01527942|Primary|Change in Pain Relief Score on the 5-point Pain Relief Score Between Baseline and 24 Hours|The 5-point Pain Relief Score is self-reported and scores range from 0=none, 1=little, 2=some, 3=a lot, 4=complete. Change = (24 hour score - baseline)|baseline and 24 hours|Study was terminated - data were determined to be unusable by IRB due to consent issues.|||||
683458|NCT01527513|Secondary|Change From Baseline in Seizure Frequency During the One-year Open-Label (OL)|Overall Change from Baseline in Seizure Frequency per week for the One-Year Open-Label Period|Weeks 1 to ≥ 41 weeks|Modified Efficacy Intent-to-Treat (ITT) population– all randomized patients who received at least one dose of study treatment after randomization and had at least one post-baseline seizure frequency assessment.||Seizure per week||Standard Error|Mean
683459|NCT01527513|Secondary|Change From Baseline in Standardized Seizure Frequency - Part I||Baseline; Titration Period (4 Weeks: V2-V3-V4)|Modified Efficacy ITT population – all randomized patients who received at least one dose of study treatment after randomization and had at least one post-baseline seizure frequency assessment.||Seizures per week||Standard Deviation|Mean
683460|NCT01527513|Primary|Change From Baseline in Power of Attention Score to the End of the Double Blind (DB) Period|Power of Attention was defined as the sum of the reaction time measures from the attentional tasks (simple [dominant hand only] reaction time, choice reaction time and digit vigilance speed) in order to assess information processing speed and attention/psychomotor speed.Change from baseline to the end of the double-blind period in Power of Attention will be compared between the treatment groups using an ANCOVA. Non-inferiority of ESL vs Placebo will be assessed by comparing the 95% CI’s upper bound of the difference of Least Squares Mean (LSmeans) between treatment groups (ESL-placebo) with 121 ms. If the upper bound is greater than 121 ms then the null hypothesis that the change from baseline in the Power of Attention score in ESL group is at least 121 ms inferior than the placebo group will be rejected. Single Values were calculated the average of post treatment visits (visits 5 and 7or EDV) minus average of baseline visits (visits 1 and 2)|Visit 1 (-4 weeks for training), Visit 2 (Day 1), Visit 5 (6 weeks), Visit 7 (12 weeks) or at early discontinuation visit (EDV)|The primary analysis was based on the Cognitive Per-protocol (PP) population – all patients in the Modified Cognitive Intent-to-Treat (ITT) population who completed the 8-week maintenance period and were not Important Protocol Deviations (IPDs) with respect to the primary cognitive endpoint.||Milli seconds (ms)||Standard Error|Mean
683461|NCT01527487|Secondary|Disease-Free Survival (DFS) at 2 Years|Defined as the percent probability that participants had not experienced disease recurrence or died from any cause at 2 years post-surgery, analyzed by Kaplan-Meier methodology.|24 months|Includes all patients that completed surgery.||percent probability of survival||95% Confidence Interval|Number
683462|NCT01527487|Secondary|Clinical Response Rate (cRR) of ErC as Neoadjuvant Therapy|Defined as the number of patients with a best response of clinical complete or partial response (cCR or cPR) divided by the number of patients qualified for tumor response analysis per Response Evaluation Criteria in Solid Tumors Criteria (RECIST) v1.1 for target lesions and assessed by MRI or CT. Complete Response (CR) defined as disappearance of all target lesions; Partial Response (PR) defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD;|43 months|All patients evaluated/evaluable per RECIST v1.1||percentage of participants|||Number
683463|NCT01527487|Secondary|The Number of Adverse Events as a Measure of Safety and Tolerability.|Treatment-Related Adverse Events occurring in >= 15% of treated patients|43 months|||participants|||Number
683464|NCT01527487|Primary|Pathologic Complete Response (pCR) Rate in Patients Treated With ErC for 6 Cycles Prior to Surgery|One cycle = 21 days. Pathologic CR is defined as the absence of invasive tumor in the breast and lymph node tissue removed at the time of definitive surgery as judged by the local pathologist.|18 weeks|Patients who completed 6 cycles and proceeded to surgery.||percentage of surgical patients|||Number
683465|NCT01527370|Primary|Number of Participants With Serious Adverse Events|"A serious adverse event is one that results in death, is life-threatening, results in a persistent or significant disability, results in or prolongs hospitalization, results in a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an other important medical event based on medical judgment."|Up to 42 days postvaccination|This endpoint was analyzed in all participants who were vaccinated and had any safety follow up data.||Participants|||Number
683466|NCT01527370|Primary|Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers at 6 Weeks Postvaccination|GMFR was analyzed as the geometric mean of the ratio of VZV antibody titer (gpELISA units/mL) at postvaccination week 6 over VZV antibody titer (gpELISA units/mL) at prevaccination day 1.|Prevaccination up to 6 weeks postvaccination|This endpoint was analyzed in the per-protocol population which included all participants who were vaccinated and had no major deviations from the protocol procedure. At the week 6 postvaccination timepoint, a total of 7 participants were excluded from the per-protocol immunogenicity analyses.||Ratio||95% Confidence Interval|Geometric Mean
683467|NCT01527370|Primary|The Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody at 6 Weeks Postvaccination|Antibody titers were measured by VZV-specific glycoprotein enzyme-linked immunosorbent assay (gpELISA).|Prevaccination up to 6 weeks postvaccination|This endpoint was analyzed in the per-protocol population which included all participants who were vaccinated and had no major deviations from the protocol procedure. At the week 6 postvaccination timepoint, a total of 7 participants were excluded from the per-protocol immunogenicity analyses.||gpELISA units/mL||95% Confidence Interval|Geometric Mean
683468|NCT01527162|Secondary|Assessment of Life Habits for Children (LIFE-H)|Participation in habits of daily life will be by parental report of the Life Habits questionnaire(Life-H for children) by the weighted total score on a scale of 0 to 9, with a higher score representing more participation in habits of daily life.|previous 7 day reference|||units on a scale||Standard Deviation|Mean
683469|NCT01527162|Secondary|Physical Activity Scale for Kids - Performance Version (ASKp)|Physical activity will be by parental report of Physical Activities Scale for Kids performance version (ASKp) survey- total score. Scale ranges from 0 to 100 with higher scores representing more physical activity. A score of 100 on this criterion referenced evalutive measure is consistent with physical activity like that of a typically developing 5 year old.|previous 7 day reference|||units on a scale||Standard Deviation|Mean
683470|NCT01527162|Primary|Walking Activity Levels|Daily walking activity will be measured with the StepWatch accelerometer documenting average strides/day.|average of 5 days of second week of intervention|||average total strides/day||Standard Deviation|Mean
683483|NCT01527006|Secondary|Palatability Questionnaire Assessment - Based on Its Taste, Smell, and How it Felt in the Mouth, How Easy or Difficult Was it for You / Your Child to Take This Medicine Every Day [Core Study]|The Palatability Questionnaire was answered directly by participants in Cohort ( ≥ 7 to ≤ 12 years) and indirectly by participants in Cohort ( ≥ 2 to ≤ 7 years) via their parents/caregivers. Participants selected their response from one of the five options (very easy, easy, neither easy or difficult, difficult and very difficult).|Week 5 or at the time of early discontinuation|The Safety Analysis Set, defined as participants who received study drug treatment and had at least 1 postdose safety assessment.||Participants|||Number
683471|NCT01527006|Secondary|The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase]|The Clinical Global Impression (CGI) evaluated perceived seizure frequency and severity, the occurrence of AEs, and overall functional status of the participant. The investigator performed the Clinical Global Impression of Severity for all participants at Baseline (Week 0). The evaluation used a 7-point scale where 1=normal, not at all ill and 7=extremely ill. The investigator performed the Clinical Global Impression of Change for all participants at planned visit and at EOT (the duration after the day of first study drug dose up to 7 days after the Extension Phase drug dose, inclusive). The evaluation used a 7-point scale where 1=very much improved and 7=very much worse. This tool was used to assess the participant's status over the 4-week period prior to the planned/EOT visits compared to Baseline (Week 0).|Week 0 (Baseline), Week 11, Week 28, Week 52 or EOT|The Full Analysis Set included all subjects who took at least 1 dose of perampanel during the Extension Phase, and had any seizure frequency data during the 2-week Pretreatment Phase plus the 4 weeks prior to Pretreatment Phase (Visit 1) of the Core Study and had any seizure frequency data during the Extension Phase.||Participants|||Number
683472|NCT01527006|Secondary|Seizure-free Rate During the Overall Treatment Duration [Extension Phase]|Seizure-free rate, defined as the percentage of participants who were seizure-free during the Maintenance Period. The percentage of participants who were seizure free was assessed from Week 1 of perampanel treatment through successive 13-week intervals for overall seizures, overall partial seizures, overall generalized seizures, and unclassified seizures with baseline as Pretreatment Phase (Visit 1) of 2 weeks plus 4 weeks Prior to Pretreatment Phase. The data is presented as the percentage of participants.|Baseline [2 weeks Pretreatment Phase (Visit 1) plus 4 weeks Prior to Pretreatment Phase], Weeks 1-13, Weeks 14-26, Weeks 27-39, and Weeks 40-52|The Full Analysis Set included all subjects who took at least 1 dose of perampanel during the Extension Phase, and had any seizure frequency data during the 2-week Pretreatment Phase plus the 4 weeks prior to Pretreatment Phase (Visit 1) of the Core Study and had any seizure frequency data during the Extension Phase.||Percentage of participants|||Number
683473|NCT01527006|Secondary|50 % Responder Rate During the Overall Treatment Duration by 13-week Intervals [Extension Phase]|Responder rate was defined as the proportion of participants with a 50% decrease in 28-day seizure frequency during the overall treatment duration. The percentage of responders was assessed from Week 1 of perampanel treatment through successive 13-week intervals for overall seizures, overall partial seizures, overall generalized seizures, and unclassified seizures with baseline as Pretreatment Phase (Visit 1) of 2 weeks plus 4 weeks Prior to Pretreatment Phase. The data is presented as percentage of responders.|Baseline [2 weeks Pretreatment Phase (Visit 1) plus 4 weeks Prior to Pretreatment Phase], Weeks 1-13, Weeks 14-26, Weeks 27-39, and Weeks 40-52|The Full Analysis Set included all subjects who took at least 1 dose of perampanel during the Extension Phase, and had any seizure frequency data during the 2-week Pretreatment Phase plus the 4 weeks prior to Pretreatment Phase (Visit 1) of the Core Study and had any seizure frequency data during the Extension Phase.||Percentage of responders|||Number
683474|NCT01527006|Secondary|Percentage Change From Baseline in Seizure Frequency Per 28 Days During the Overall Treatment Duration by 13-week Intervals [Extension Phase]|Seizure frequency was derived from information (seizure count and type) recorded in participant diary. The seizure frequency per 28 days was calculated the number of seizures over the time interval multiplied by 28 and divided by the number of days in the interval. The percent change in 28-day seizure frequency from baseline was assessed for overall seizures, overall partial seizures, overall generalized seizures, and unclassified seizures. The data is presented as mean percent change +/- standard deviation.|Baseline [2 weeks Pretreatment Phase (Visit 1) plus 4 weeks Prior to Pretreatment Phase], Weeks 1-13, Weeks 14-26, Weeks 27-39, and Weeks 40-52|The Full Analysis Set included all subjects who took at least 1 dose of perampanel during the Extension Phase, and had any seizure frequency data during the 2-week Pretreatment Phase plus the 4 weeks prior to Pretreatment Phase (Visit 1) of the Core Study and had any seizure frequency data during the Extension Phase.||Percent change||Full Range|Median
683475|NCT01527006|Other Pre-specified|The Effect of the Most Common Concomitant AEDs on Population PK Parameters: Tmax|This outcome was not assessed in the study.|11 weeks|This outcome was not assessed in the study.|||||
683476|NCT01527006|Other Pre-specified|The Effect of the Most Common Concomitant AEDs on Population PK Parameters: Cmax|This outcome was not assessed in the study.|11 weeks|This outcome was not assessed in the study.|||||
683477|NCT01527006|Other Pre-specified|The Effect of the Most Common Concomitant AEDs on Population PK Parameters: AUC|This outcome was not assessed in the study.|11 weeks|This outcome was not assessed in the study.|||||
683478|NCT01527006|Other Pre-specified|The Effect of Demographics on Population PK Parameters: Tmax|This outcome was not assessed in the study.|11 weeks|This outcome was not assessed in the study.|||||
683479|NCT01527006|Other Pre-specified|The Effect of Demographics on Population PK Parameters: Cmax|This outcome was not assessed in the study.|11 weeks|This outcome was not assessed in the study.|||||
683480|NCT01527006|Other Pre-specified|The Effect of Demographics on Population PK Parameters: AUC|This outcome was not assessed in the study.|11 weeks|This outcome was not assessed in the study.|||||
683481|NCT01527006|Secondary|Palatability Questionnaire Assessment - Would You/Your Child Have Preferred This Medicine to Have Been Flavored, e.g. Fruity [Core Study]|The Palatability Questionnaire was answered directly by participants in Cohort ( ≥ 7 to ≤ 12 years) and indirectly by participants in Cohort ( ≥ 2 to ≤ 7 years) via their parents/caregivers. Participants selected their response from one of the three options (yes, no and don't mind).|Week 5 or at the time of early discontinuation|The Safety Analysis Set, defined as participants who received study drug treatment and had at least 1 postdose safety assessment.||Participants|||Number
683482|NCT01527006|Primary|Steady-state Average Concentration (C av,ss) of Perampanel [Core Study]|C av,ss was calculated as 'Dose (mg)/Dosing Interval (24 h)/(CL/F [L/h]) x 1000'. C av,ss during a dosing interval was dose-normalized to 0.12 mg/kg in participants aged ≥ 2 to less than 12 years (intended to correspond to 8 mg/70 kg in adults/adolescents). Blood samples were collected at day 8, Day 36, Day 64 , and Day 78. C av,ss values were calculated for each visit and averaged to derive the total C av,ss value per arm. Data was analysed for 2 categories: CYP3A4/5 inducers (carbamazepine, oxcarbazepine and phenytoin) and non-inducers. Data is presented as mean Liter per hour +/- standard deviation.|From Day 8 up to Day 78|The PK analysis set, defined as participants with at least 1 pharmacokinetic assessment of perampanel with a documented dosing history.||ng/mL||Standard Deviation|Mean
683484|NCT01527006|Secondary|Palatability Questionnaire Assessment - How Does This Medicine Smell [Core Study]|The Palatability Questionnaire was answered directly by participants in Cohort ( ≥ 7 to ≤ 12 years) and indirectly by participants in Cohort ( ≥ 2 to ≤ 7 years) via their parents/caregivers. Participants selected their response from one of the five options (very good, good, not good-not bad, bad, very bad).|Week 5 or at the time of early discontinuation|The Safety Analysis Set, defined as participants who received study drug treatment and had at least 1 postdose safety assessment.||Participants|||Number
683485|NCT01527006|Secondary|Palatability Questionnaire Assessment - How Does This Medicine Taste [Core Study]|The Palatability Questionnaire was answered directly by participants in Cohort ( ≥ 7 to ≤ 12 years) and indirectly by participants in Cohort ( ≥ 2 to ≤ 7 years) via their parents/caregivers. Participants selected their response from one of the five options (very good, good, not good-not bad, bad, very bad).|Week 5 or at the time of early discontinuation|The Safety Analysis Set, defined as participants who received study drug treatment and had at least 1 postdose safety assessment.||Participants|||Number
683486|NCT01527006|Secondary|Number of Participants With Treatment Emergent Non-Serious Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Perampanel|An AE was defined as any untoward medical occurrence in a participant administered with the study drug. A SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening (ie, the participant was at immediate risk of death from the AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was as a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug up to 30 days after the final dose of study drug) were assessed. The details of the adverse events are presented in the safety section of the results.|For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase|The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.||Participants|||Number
683487|NCT01527006|Secondary|The Clinical Global Impression of Change at the End of Treatment (EOT) [Core Study]|The Clinical Global Impression (CGI) evaluated perceived seizure frequency and severity, the occurrence of AEs, and overall functional status of the participant. The investigator performed the Clinical Global Impression of Severity for all participants at Baseline (Week 0). The evaluation used a 7-point scale where 1=normal, not at all ill and 7=extremely ill. The investigator performed the Clinical Global Impression of Change for all participants at the EOT (the duration after the day of first study drug dose up to 7 days after the last Core Phase drug dose, inclusive). The evaluation used a 7-point scale where 1=very much improved and 7=very much worse. This tool was used to assess the participant's status over the 4-week period prior to its completion compared to Baseline (Week 0).|Week 0 (Baseline), Week 11 or EOT|The Full Analysis Set, defined as participants who received study drug, had any seizure frequency data during the 2-week Pretreatment Phase plus the 4 weeks prior to the Pretreatment Phase (Visit 1), and during the Treatment Phase of the Core Study.||Participants|||Number
683488|NCT01527006|Secondary|Seizure-free Rate During the Maintenance Period [Core Study]|Seizure-free rate, defined as the percentage of participants who were seizure-free during the Maintenance Period. SG = Secondary Generalization.|Week 9 to Week 11|The full analysis set, defined as participants who received study drug, had any seizure frequency data during the 2-week Pretreatment Phase plus the 4 weeks prior to the Pretreatment Phase (Visit 1), and during the Treatment Phase of the Core Study.||Percentage of participants|||Number
683489|NCT01527006|Secondary|50% Responder Rate During the Maintenance Period-LOCF [Core Study]|Responder rate was defined as the proportion of participants with a 50% decrease in 28-day seizure frequency during the Maintenance Period compared to Baseline [2 weeks Pretreatment Phase (Visit 1) plus 4 Weeks Prior to Pretreatment Phase] for overall seizures, overall partial seizures, overall generalized seizures, and unclassified seizures. The data is presented as percent responders. LOCF = Last Observation Carried Forward.|Baseline [2 weeks Pretreatment Phase (Visit 1) plus 4 weeks Prior to Pretreatment Phase], Week 9 to 11|The full analysis set, defined as participants who received study drug, had any seizure frequency data during the 2-week Pretreatment Phase plus the 4 weeks prior to the Pretreatment Phase (Visit 1), and during the Treatment Phase of the Core Study.||Percent responders|||Number
683490|NCT01527006|Primary|Apparent Clearance (CL/F) of Perampanel [Core Study]|CL/F was defined as the volume of plasma cleared of the drug per unit time. Blood samples were collected at day 8, Day 36, Day 64 , and Day 78. The CL/F values were calculated for each visit and averaged to derive the total CL/F value per arm. Data was analyzed for 2 categories: CYP3A4/5 inducers (carbamazepine, oxcarbazepine and phenytoin) and non-inducers. Data is presented as mean Liter per hour +/-standard deviation.|From Day 8 up to Day 78|The pharmacokinetic (PK) analysis set, defined as participants with at least 1 pharmacokinetic assessment of perampanel with a documented dosing history.||Liter per hour||Standard Deviation|Mean
683491|NCT01527006|Secondary|Percent Change From Baseline in Seizure Frequency Per 28 Days in Treatment Phase [Core Study]|Seizure frequency was derived from information (seizure count and type) recorded in participant diary. The seizure frequency per 28 days was calculated the number of seizures over the time interval multiplied by 28 and divided by the number of days in the interval. The percent change in 28-day seizure frequency from baseline was assessed for overall seizures, overall partial seizures, overall generalized seizures, and unclassified seizures. The data is presented as mean percent change +/- standard deviation.|Baseline [2 weeks Pretreatment Phase (Visit 1) plus 4 weeks Prior to Pretreatment Phase], Week 0 to Week 15|The full analysis set, defined as participants who received study drug, had any seizure frequency data during the 2-week Pretreatment Phase plus the 4 weeks prior to the Pretreatment Phase (Visit 1), and during the Treatment Phase of the Core Study.||Percent change||Full Range|Median
683492|NCT01526902|Secondary|Subjective Vision Assessments: High Contrast Near Visual Quality|Subjects instructed to rate Vision quality at distance, intermediate and near vision (OU) using a 0-100 numerical scale where 0 = poor and 100 = excellent.|After 1 hour of lens wear|Per Protocol||units on a scale||Standard Deviation|Mean
683493|NCT01526902|Primary|Objective Vision Assessments: High Contrast Near Visual Acuity|Tested with charts set at near point (40cm)distant to the subject with both eyes together in normal lighting conditions. The unit of measure is logMAR units (logarithm of the minimum angle of resolution) A logMAR acuity of 0.0 equates to 20/20 Snellen acuity. Positive logMAR values indicate poorer vision and negative values denote better visual acuity than baseline 20/20 value.|After 1 hour of lens wear|Per Protocol||logMAR units||Standard Deviation|Mean
683494|NCT01526902|Primary|Objective Vision Assessments: High Contrast Intermediate Visual Acuity|Tested with charts at intermediate distance (100cm)distant to the subject with both eyes together in normal lighting conditions. The unit of measure is logMAR units (logarithm of the minimum angle of resolution) A logMAR acuity of 0.0 equates to 20/20 Snellen acuity. Positive logMAR values indicate poorer vision and negative values denote better visual acuity than baseline 20/20 value.|After 1 hour of lens wear|Per Protocol||logMAR units||Standard Deviation|Mean
683495|NCT01526902|Secondary|Subjective Vision Assessments: High Contrast Intermediate Visual Quality|Subjects instructed to rate Vision quality at distance, intermediate and near vision (OU) using a 0-100 numerical scale where 0 = poor and 100 = excellent.|After 1 hour of lens wear|Per Protocol||units on a scale||Standard Deviation|Mean
683496|NCT01526902|Secondary|Subjective Overall Vision: High Contrast Distance Visual Quality|Subjects instructed to rate Vision quality at distance, intermediate and near vision (OU) using a 0-100 numerical scale where 0 = poor and 100 = excellent.|After 1 hour of lens wear|Per Protocol||units on a scale||Standard Deviation|Mean
683497|NCT01526902|Primary|Objective Vision Assessments: High Contrast Distance Visual Acuity|Tested with charts distant to the subject with both eyes together in normal lighting conditions. The unit of measure is logMAR units (logarithm of the minimum angle of resolution) A logMAR acuity of 0.0 equates to 20/20 Snellen acuity. Positive logMAR values indicate poorer vision and negative values denote better visual acuity than baseline 20/20 value.|After 1 hour of lens wear|Per Protocol||logMAR units||Standard Deviation|Mean
683498|NCT01526785|Secondary|Change From Baseline in Forced Vital Capacity (FVC) at Week 52- At Sitting Position|Percent predicted FVC values are reported. FVC is the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in litres. Predicted forced vital capacity is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FVC = (observed value)/(predicted value) * 100%.|Baseline, Week 52|Full analysis population. Number of participants analysed = participants with baseline and Week 52 FVC data.||percent predicted FVC||Standard Deviation|Mean
683499|NCT01526785|Secondary|Change From Baseline in Forced Vital Capacity (FVC) at Week 52- At Supine Position|Percent predicted FVC values are reported. FVC is the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in litres. Predicted forced vital capacity is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FVC = (observed value)/(predicted value) * 100%.|Baseline, Week 52|Full analysis population. Number of participants analysed = participants with baseline and Week 52 FVC data.||percent predicted FVC||Standard Deviation|Mean
683500|NCT01526785|Secondary|Change From Baseline on Gross Motor Function Measure-88 (GMFM-88) at Week 52|GMFM-88 (88-item measure to detect gross motor function) consists of 5 components, each measured on a 4-point Likert scale.The score for each dimension was expressed as a percentage of the maximum score for that dimension.Total score ranges from 0% to 100%, where higher scores indicate better motor functions.|Baseline, Week 52|Full analysis population. Number of participants analysed = participants with baseline and Week 52 GMFM-88 data.||percentage of total score||Standard Deviation|Mean
683501|NCT01526785|Secondary|Change From Baseline on Left Ventricular Mass Z-Score (LVM-Z) at Week 52|Z-Scores indicate the number of standard deviations (SD) from the mean in a normal distribution. A negative change from baseline indicates an increase in LVM-Z score. The normal range is -2 to 2 and greater than 2 may indicate left ventricular hypertrophy.|Baseline, Week 52|Full analysis population. Number of participants analyzed = participants with available data at Week 52 for this outcome.||Z score||Standard Deviation|Mean
683502|NCT01526785|Secondary|Invasive Ventilator-Free Survival Rate at Week 52|Percentage of participants, who were invasive ventilator-free at week 52, are reported. Invasive ventilation was defined as mechanical ventilatory support applied with the use of an endotracheal tube or tracheostomy. Invasive ventilator-free survival rate was calculated by Kaplan-Meier estimate.|Week 52|Full analysis population. Number of participants analyzed = participants with available data at Week 52 for this outcome.||percentage of participants||95% Confidence Interval|Number
683503|NCT01526785|Secondary|Survival Rate at Week 52|Percentage of participants who were alive at Week 52, were reported. Survival rate was calculated by Kaplan-Meier estimate.|Week 52|Full analysis population.||percentage of participants||95% Confidence Interval|Number
683504|NCT01526785|Primary|Percentage of Participants Who Were Clinically Stable or Improved at Week 52|Clinical stability was defined as absence of death due to disease progression or new dependency on invasive ventilation and; decline in cardiac status, motor function, and pulmonary function from baseline.|Week 52|Full analysis population. Number of participants analyzed = participants with available data at Week 52 for this outcome.||percentage of participants||95% Confidence Interval|Number
683505|NCT01526733|Secondary|Duration of Insulin Action (AUMC[0-360]/AUC[0-360])|Duration of insulin action was calculated by dividing the area under the first moment curve (AUMC[0-360]) by the area under the concentration versus time curve (AUC[0-360]). Blood samples were collected 10 minutes predose and at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|10 minutes predose up to 360 minutes postdose on Days 1 and 4|Participants who completed both phases of the study and with evaluable AUMC(0-360)/AUC(0-360) data.||ratio||Standard Deviation|Mean
683506|NCT01526733|Secondary|Area Under the Glucose Concentration Curve (AUC[0-360])|Area under the glucose concentration curve from 0 to 360 minutes (AUC[0-360]) is presented. Blood samples were collected 30 and 10 minutes prior to insulin bolus and at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|30 minutes predose up to 360 minutes postdose Days 1 and 4|Participants who completed both phases of the study and with evaluable AUC(0-360) data.||picomoles*minutes/liter||Standard Deviation|Mean
683507|NCT01526733|Secondary|Time to 50% Total Glucose Infused (50%Gtot)|Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|0 up to 360 minutes postdose on Days 1 and 4|Participants who completed both phases of the study and with evaluable 50%Gtot data.||minutes||Standard Deviation|Mean
683508|NCT01526733|Secondary|Time to 50% Maximum Glucose Infusion Rate (tGIR50%Max)|Early and late tGIR50%max are presented. Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|0 up to 360 minutes postdose on Days 1 and 4|Participants who completed both phases of the study and with evaluable early and late tGIR50%max data.||minutes||Standard Deviation|Mean
683509|NCT01526733|Secondary|Time to First Occurrence of Maximum Glucose Infusion Rate (tGIRmax)|Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|0 up to 360 minutes postdose on Days 1 and 4|Participants who completed both phases of the study and with evaluable tGIRmax data.||minutes||Standard Deviation|Mean
683510|NCT01526733|Secondary|Maximum Glucose Infusion Rate (GIRmax)|Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|0 up to 360 minutes postdose on Days 1 and 4|Participants who completed both phases of the study and with evaluable GIRmax data.||milligrams/kilogram/minute||Standard Deviation|Mean
683511|NCT01526733|Primary|Early Insulin Exposure (%AUC[0-60])|Early insulin exposure, defined as the percentage of total insulin exposure (area under the insulin concentration curve [AUC{0 360}]) that occurs within the first hour following bolus dose of insulin during the 2 euglycemic clamps is presented. Blood samples were collected 10 minutes predose and at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|10 minutes predose up to 60 minutes postdose on Days 1 and 4|Participants who completed both phases of the study and with evaluable %AUC(0-60) data.||percentage of AUC(0-60)||Standard Deviation|Mean
683512|NCT01526629|Primary|Remote Follow-up as an Alternative to Onsite Visit|Evaluate the percentage of patients who had a successful remote follow up, as an alternative to onsite visit for patients implanted with a fully automatic ICD|13 months|||Participants|||Count of Participants
683513|NCT01526551|Primary|Number of Students Who Completed HPV Vaccination as a Result of the School-based Program|Number of students who returned a parental consent form and ultimately completed the full HPV vaccination series as a result of the school-based program|August 2012 -- June 2013|||participants|||Number
683514|NCT01526551|Primary|Number of Students Who Initiated the HPV Vaccine Series as a Result of the School-based Program|Number of students who returned a parental consent form and ultimately initiated the HPV vaccine series as a result of the school-based program|August 2012-June 2013|||participants|||Number
683515|NCT01526538|Secondary|Learning Task by Itami and Uno||At the baseline laboratory visit|||% correct||Standard Error|Mean
683516|NCT01526538|Primary|Medication Side-effects|self-report of medication side effects (Units of Measure is the count of specific reported effects)|1 month post-treatment.|||Adverse event reports|||Number
683517|NCT01526538|Primary|Urinalysis Benzoylecgonine (Cocaine Metabolite)(ng/ml)|The primary outcome for this study will be post-treatment continuous abstinence, as assessed by urinalysis results|1 month post-treatment|||ng/ml||Standard Deviation|Mean
683518|NCT01526343|Primary|Freedom From Atrial Tachyarrhythmias (ATAs)||ILR monitoring at 12 months|Participants with available data at 1 year and who were compliant with use of each device.||Participants|||Number
683519|NCT01526343|Primary|Number of ATA (Atrial Tachyarrhythmias) Episodes and Burden, Determined at Defined Postoperative Intervals||ILR monitoring obtained at 3, 6 and 12 months|||ATA episodes|||Number
683520|NCT01526213|Primary|Primary Pharmacokinetic Measure: Area Under the Curve (AUC)||0-72 hours|||micromolar*hr||Full Range|Geometric Mean
683521|NCT01526148|Secondary|Lithium vs. Quetiapine Effects on General Cardiovascular Disease Risk as Measured by Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)|Change in homeostatic model assessment for insulin resistance (HOMA-IR) from screening to end of study. Insulin resistance is a condition in which cells fail to respond to the normal actions of the hormone in the body. The HOMA-IR is calculated using a subject's fasting plasma insulin and glucose levels. The higher the score, the higher the level of insulin resistance.|Screening and Week 16|||IR Score||Standard Deviation|Mean
683522|NCT01526148|Primary|Time to Study Discontinuation|The time, as measured in number of days, for discontinuation due to all causes will be measured and used as the primary outcome measure|Week 16|||days||95% Confidence Interval|Mean
683523|NCT01525927|Secondary|Identify Additional Toxicity of Treatment|To identify additional toxicity of treatment|During therapy and up to 5 years following completion of treatment||||||
683524|NCT01525927|Secondary|Assessment of Quality of Life Outcomes|Serial evaluation of functional quality-of-life, including M. D. Anderson Dysphagia Inventory (MDADI) and Oropharyngeal swallowing efficiency (OPSE) measures of swallowing function, as well as formal sialometric measurement of parotid function.|Baseline, during therapy and up to two years following completion of radiation phase||||||
683525|NCT01525927|Secondary|Assess Distant Disease Control at 2 Years.|3.5 To assess distant disease control at 2 years.|At two years following completion of radiation phase||||||
683526|NCT01525927|Secondary|Assess Locoregional Disease Control at 2 Years|To assess locoregional disease control at 2 years|At two years following completion of radiation phase||||||
683527|NCT01525927|Secondary|Assess Overall Survival at 2 Years.|To assess overall survival at 2 years.|At two years following completion of radiation phase||||||
683528|NCT01525927|Secondary|Progression-free Survival at 2 Years|assess Progression-free survival at 2 years.|At two years following completion of radiation phase||||||
683529|NCT01525927|Secondary|To Define Objective Tumor Response Rates to Induction Chemotherapy and to Subsequent Radiation-based Treatment.|To define objective tumor response rates to induction chemotherapy and to subsequent radiation-based treatment, per RESIST version 1.1 criteria.|Three months following completion of radiation therapy phase.||||||
683530|NCT01525927|Primary|Response (CR+PR) Status at 3 Months Post-therapy|"The 3-month response rate will be estimated using standard methods for estimating proportions and their 95% one-sided confidence intervals (CIs). Comparison to the historical control data will be carried out using a chi-square test for comparing proportions (or a Fisher exact test if an expected cell frequency in the 2x2 table is less than 5).
Zero (0) participants analyzed"|3 months following completion of radiation phase|No study intervention or data collected.|||||
683531|NCT01525849|Secondary|Recovery Time|Mean time (days) after procedure for participants to return to normal activities|6-months|All treated participants with 6-month follow-up.||days||Standard Deviation|Mean
683535|NCT01525849|Primary|Sinus Symptom Improvement|Change from baseline in overall 20-item Sino-Nasal Outcome Test (SNOT-20) score. The SNOT-20 is a validated patient reported survey of 20 items related to sinonasal symptoms and severity assessed over the previous 2 weeks. Each item is scored from 0 (no problem) to 5 (problem as bad as it can be). The individual item scores are averaged to provide and overall score that ranges from 0 (best) to 5 (worst).|Baseline and 1-year|All treated participants with matched pair SNOT-20 data at baseline and 1-year.||units on a scale||Standard Deviation|Mean
683536|NCT01525745|Secondary|Survival|Progrsesion Free and Overall Survival|2 years|data not collected, therefore no analysis done|||||
683537|NCT01525745|Secondary|Long Term Effects of Image-guided Radiosurgery/SBRT|Long term effects of image-guided radiosurgery/SBRT on the vertevral bone and spinal cord|2 years|data not collected, therefore no analysis done|||||
683538|NCT01525745|Secondary|Quality of Life|Evaluate potential benefit of image-guided radiosurgery/SBRT on change in and overall quality of life as measured by FACT-G, BPI and EQ-5D|2 years|data not collected, therefore no analysis done|||||
683539|NCT01525745|Secondary|Duration of Pain Response|Determine if image-guided radiosurgery/SBRT improves duration of pain as compared to conventional external beam radiotherapy|2 years|data not collected, therefore no analysis done|||||
683540|NCT01525745|Primary|Pain Control as Measured by NPRS|Determine if image-guided radiosurgery/SBRT improves pain control as measured by NPRS as compared to conventional external beam radiotherapy|2 years|study was terminated by the local IRB due to slow accrual. 1 participant withdrew consent and 1 participant did not complete the assigned arm treatment per protocol and then removed from study. left with 4 participants and data were not collected for any participants therefore no analysis has been done.|||||
683541|NCT01525667|Secondary|Change From Day 0 to Week 26 in the Visual Analog Scale (VAS) Pain Score.|Visual Analog Scale (VAS) Pain Score ranges from 0 mm (no pain) to 100 mm (worse possible pain)|Day 0 to Week 26|||mm||Standard Error|Least Squares Mean
683542|NCT01525667|Secondary|Change From Day 0 to Week 26 in the Ratio of Injured to Contralateral Pelvic Shift .|Change from Visit 2 (Day 0) to Week 26 in the Ratio of Injured to Contralateral Pelvic Shift as Measured by Gait Analysis|Day 0 to Week 26|||Ratio||Standard Error|Least Squares Mean
683543|NCT01525667|Secondary|Change From Day 1 to Week 12 in Mean Fiber Diameter.|Change from Visit 3 (Day 1) to Week 12 in Mean Fiber Diameter as Measured by Muscle Biopsy.|Day 1 to Week 12|||microns||Standard Error|Least Squares Mean
683544|NCT01525667|Secondary|Change From Day 0 to Week 26 in Muscle Volume.|Change from Visit 2 (Day 0) to Week 26 in Muscle Volume as Measured by MRI.|Day 0 to Week 26|||mm3||Standard Error|Least Squares Mean
683545|NCT01525667|Primary|Change From Day 0 to Week 26 in the Maximal Voluntary Isometric Contraction (MVIC) Moment of the Injured Side to Assess Gluteus Medius Strength.|Change from Visit 2 (Day 0) to Week 26 in the maximal voluntary isometric contraction (MVIC) moment of the injured side as measured by isometric dynamometry to assess Gluteus Medius force strength.|Day 0 to Week 26|||Newtons||Standard Error|Least Squares Mean
683546|NCT01525641|Secondary|Onset or Offset of Wearing-off Phenomenon in Patients With Concomitant L-DOPA|Number of patients with onset or offset of wearing-off phenomena in patients with concomitant levodopa (L-DOPA). Wearing-off is when Parkinson's symptoms begin to reappear or become noticeably worse before it is time to take the next scheduled dose of medication.|Week 52|Patients in safety set and with concomitant L-DOPA||participants|||Number
683547|NCT01525641|Secondary|Onset or Offset of On and Off Phenomenon in Patients With Concomitant L-DOPA|"Number of patients with onset or offset of on-off phenomenon in patients with concomitant levodopa (L-DOPA). On-off phenomenon is the unpredictable shift from mobility - on - to a sudden inability to move - off."|Week 52|Patients in safety set and with concomitant L-DOPA.||participants|||Number
683548|NCT01525641|Secondary|Change From Baseline in the Modified Hoehn & Yahr to Last Observation|Change from baseline at the last observation in the modified Hoehn and Yahr stage. Stages of the Parkinson's disease will be assessed on an 8-degree scale between stage 0 (no sign of the disease) and 5 (wheelchair bound or bedridden unless aided) in steps of 0, 1, 1.5, 2, 2.5, 3, 4 and 5. A reduction in the score over time represents an improvement.|Baseline and week 52|Efficacy set||Units on a scale||Standard Deviation|Mean
683549|NCT01525641|Secondary|Change From Baseline in Total Score of the UPDRS Part III to Last Observation|"Change from baseline at the last observation in the Unified Parkinson’s Disease Rating Scale (UPDRS) Part III total score.
UPDRS Part III (motor examination) measures the extent of physical impairment displayed by the patient. This evaluation consists of 14 separate components of patient’s physical status.
The UPDRS part III score is the sum of the 14 individual components. The UPDRS Part III total score ranges from 0 to 108.A reduction in UPDRS part III score over time corresponds to an improvement in motor activities.
The following are the 14 separate components:1. Speech 2. Facial expression 3. Tremor at rest 4. Action or postural tremor of hands 5. Rigidity 6. Finger taps 7. Hand movements 8. Rapid alternating movements of hands 9. Leg agility 10. Arising from chair 11. Posture 12. Gait 13. Postural stability 14. Body bradykinesia and hypokinesia."|Baseline and week 52|Efficacy set||units on a scale||Standard Deviation|Mean
683550|NCT01525641|Secondary|Clinical Global Impression of Effect|Clinical global impression (CGI) of effect at the last observation, on a rating scale from very much improved to no effect.|Week 52|Efficacy set: included all patients in the “safety set” except those who had no available efficacy data and/or who did not suffer from Parkinsons Disease||participants|||Number
683551|NCT01525641|Primary|Percentage of Adverse Drug Reactions|Percentage of subjects with adverse drug reactions|From baseline up to week 52|Safety set||percentage of participants|||Number
683552|NCT01525628|Secondary|Number of Participants With Sustained Virological Response (SVR12)|Sustained virologic response (SVR12): Plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level <25 IU/mL(international units per millilitre) undetectable at 12 weeks after the end of treatment. SVR12 was analyzed in a descriptive manner using frequency of participants who achieved SVR12.|12 weeks post treatment|Treated set (TRT): This subject set includes all patients who were dispensed trial medication and were documented to have taken at least one dose of trial drug.||Participants|||Number
683588|NCT01525615|Secondary|Adjusted Mean Inspiratory Capacity at Pre-exercise After 6 Weeks|Secondary endpoint was pre-exercise inspiratory capacity (IC) during constant work rate cycle ergometry to symptom limitation at 75% maximal work capacity (Wcap) after 6 weeks of treatment.|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline and at least one post-baseline measurement before or at Week 12 for the primary endpoint.||liters||Standard Error|Least Squares Mean
683553|NCT01525628|Primary|AUC 0-12hr of Raltegravir|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 12 hours.|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9 and 17|PKS. Due to Boehringer Ingelheim’s decision not to pursue the development of this substance, the extent of the statistical analysis was limited to selected endpoints. No further analysis is planned for the endpoints which were not related to patient efficacy or safety.|||||
683554|NCT01525628|Primary|C12hr of Raltegravir|Concentration of an analyte in plasma at 12 hours.|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9 and 17|PKS. Due to Boehringer Ingelheim’s decision not to pursue the development of this substance, the extent of the statistical analysis was limited to selected endpoints. No further analysis is planned for the endpoints which were not related to patient efficacy or safety.|||||
683555|NCT01525628|Primary|Cmax of Raltegravir|Maximum concentration of an analyte in plasma.|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9 and 17|PKS. Due to Boehringer Ingelheim’s decision not to pursue the development of this substance, the extent of the statistical analysis was limited to selected endpoints. No further analysis is planned for the endpoints which were not related to patient efficacy or safety.|||||
683556|NCT01525628|Primary|AUC 0-24hr of Tenofovir|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 hours.|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9 and 17|PKS. Due to Boehringer Ingelheim’s decision not to pursue the development of this substance, the extent of the statistical analysis was limited to selected endpoints. No further analysis is planned for the endpoints which were not related to patient efficacy or safety.|||||
683557|NCT01525628|Primary|C24hr of Tenofovir|Concentration of an analyte in plasma at 24 hours.|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9 and 17|PKS. Due to Boehringer Ingelheim’s decision not to pursue the development of this substance, the extent of the statistical analysis was limited to selected endpoints. No further analysis is planned for the endpoints which were not related to patient efficacy or safety.|||||
683558|NCT01525628|Primary|Cmax of Tenofovir|Maximum concentration of an analyte in plasma.|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9 and 17|PKS. Due to Boehringer Ingelheim’s decision not to pursue the development of this substance, the extent of the statistical analysis was limited to selected endpoints. No further analysis is planned for the endpoints which were not related to patient efficacy or safety.|||||
683559|NCT01525628|Primary|AUC 0-infinity of 1-OH-Midazolam (1-hydroxy-midazolam)|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity.|5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.|PKS. This endpoint was not planned to be analysed for groups C, D and E||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
683560|NCT01525628|Primary|Cmax of 1-OH-Midazolam (1-hydroxy-midazolam)|Maximum concentration of an analyte in plasma|5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.|PKS. This endpoint was not planned to be analysed for groups C, D and E||nmol/L||Geometric Coefficient of Variation|Geometric Mean
683561|NCT01525628|Primary|AUC 0-infinity of Midazolam|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity.|5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.|PKS. This endpoint was not planned to be analysed for groups C, D and E||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
683562|NCT01525628|Primary|Cmax of Midazolam|Maximum concentration of an analyte in plasma|5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.|PKS. This endpoint was not planned to be analysed for groups C, D and E||nmol/L||Geometric Coefficient of Variation|Geometric Mean
683563|NCT01525628|Primary|AUC 0-infinity of Tolbutamide|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity.|5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.|PKS. This endpoint was not planned to be analysed for groups C, D and E||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
683564|NCT01525628|Primary|Cmax of Tolbutamide|Maximum concentration of an analyte in plasma|5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.|PKS. This endpoint was not planned to be analysed for groups C, D and E||nmol/L||Geometric Coefficient of Variation|Geometric Mean
683565|NCT01525628|Primary|AUC 0-infinity of Caffeine|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity.|5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.|PKS. This endpoint was not planned to be analysed for groups C, D and E||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
683566|NCT01525628|Primary|Cmax of Caffeine|Maximum concentration of an analyte in plasma|5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.|PKS. This endpoint was not planned to be analysed for groups C, D and E||ng/mL||Geometric Coefficient of Variation|Geometric Mean
683567|NCT01525628|Primary|AUC 0-6hr of Deleobuvir Metabolite CD 6168 ag (Acylglucuronide)|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 6 hours|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.|The pharmacokinetic set (PKS): included all patients in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK. This endpoint was not planned to be analysed for groups C, D and E.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
683568|NCT01525628|Primary|C6hr of Deleobuvir Metabolite CD 6168 ag (Acylglucuronide)|Concentration of an analyte in plasma at 6 hours|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.|The pharmacokinetic set (PKS): included all patients in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK. This endpoint was not planned to be analysed for groups C, D and E.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
683569|NCT01525628|Primary|Cmax of Deleobuvir Metabolite CD 6168 ag (Acylglucuronide)|Maximum concentration of an analyte in plasma|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.|The pharmacokinetic set (PKS): included all patients in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK. This endpoint was not planned to be analysed for groups C, D and E.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
683570|NCT01525628|Primary|AUC 0-6hr of Deleobuvir Reduction Metabolite CD 6168|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 6 hours|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.|The pharmacokinetic set (PKS): included all patients in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK. This endpoint was not planned to be analysed for groups C, D and E.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
683571|NCT01525628|Primary|C6hr of Deleobuvir Reduction Metabolite CD 6168|Concentration of an analyte in plasma at 6 hours|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.|The pharmacokinetic set (PKS): included all patients in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK. This endpoint was not planned to be analysed for groups C, D and E.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
683572|NCT01525628|Primary|Cmax of Deleobuvir Reduction Metabolite CD 6168|Maximum concentration of an analyte in plasma|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.|The pharmacokinetic set (PKS): included all patients in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK. This endpoint was not planned to be analysed for groups C, D and E.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
683573|NCT01525628|Primary|AUC 0-6hr of Deleobuvir Metabolite Acyl-glucuronide (BI 208333)|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 6 hours|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.|The pharmacokinetic set (PKS): included all patients in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK. This endpoint was not planned to be analysed for groups C, D and E.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
683574|NCT01525628|Primary|C6hr of Deleobuvir Metabolite Acyl-glucuronide (BI 208333)|Concentration of an analyte in plasma at 6 hours|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.|The pharmacokinetic set (PKS): included all patients in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK. This endpoint was not planned to be analysed for groups C, D and E.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
683575|NCT01525628|Primary|Cmax of Deleobuvir Metabolite Acyl-glucuronide (BI 208333)|Maximum concentration of an analyte in plasma|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.|The pharmacokinetic set (PKS): included all patients in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK. This endpoint was not planned to be analysed for groups C, D and E.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
683576|NCT01525628|Primary|AUC 0-6hr of Deleobuvir (BI 207127)|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 6 hours|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.|The pharmacokinetic set (PKS): included all patients in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK. This endpoint was not planned to be analysed for groups C, D and E.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
683577|NCT01525628|Primary|C6hr of Deleobuvir (BI 207127)|Concentration of an analyte in plasma at 6 hours|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.|The pharmacokinetic set (PKS): included all patients in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK. This endpoint was not planned to be analysed for groups C, D and E.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
683578|NCT01525628|Primary|Cmax of Deleobuvir (BI 207127)|Maximum concentration of an analyte in plasma|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.|The pharmacokinetic set (PKS): included all patients in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK. This endpoint was not planned to be analysed for groups C, D and E.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
683579|NCT01525628|Primary|Area Under the Concentration-time Curve (AUC) of Faldaprevir (BI 201335) From 0 to 24 Hours|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 hours|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.|The pharmacokinetic set (PKS): included all patients in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK. This endpoint was not planned to be analysed for groups C, D and E.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
683580|NCT01525628|Primary|C24hr of Faldaprevir (BI 201335)|Concentration of an analyte in plasma at 24 hours|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.|The pharmacokinetic set (PKS): included all patients in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK. This endpoint was not planned to be analysed for groups C, D and E.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
683581|NCT01525628|Primary|Cmax of Faldaprevir (BI 201335)|Maximum concentration of an analyte in plasma|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.|The pharmacokinetic set (PKS): included all patients in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK. This endpoint was not planned to be analysed for groups C, D and E.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
683582|NCT01525615|Secondary|Adjusted Mean 1-hour, Post-dose Forced Expiratory Volume in One Second (FEV1) After 12 Weeks|Secondary endpoint was adjusted mean 1-hour, post-dose Forced Expiratory Volume in one second (FEV1) observed after 12 weeks of treatment|12 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline and at least one post-baseline measurement before or at Week 12 for the primary endpoint.||liters||Standard Error|Least Squares Mean
683583|NCT01525615|Secondary|Adjusted Mean 1-hour, Post-dose Forced Expiratory Volume in One Second (FEV1) After 6 Weeks|Secondary endpoint was adjusted mean 1-hour, post-dose Forced Expiratory Volume in one second (FEV1) observed after 6 weeks of treatment|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline and at least one post-baseline measurement before or at Week 12 for the primary endpoint.||liters||Standard Error|Least Squares Mean
683584|NCT01525615|Secondary|Adjusted Mean 1-hour, Post-dose Forced Expiratory Volume in One Second (FEV1) on Day 1|Secondary endpoint was adjusted mean 1-hour, post-dose Forced Expiratory Volume in one second (FEV1) observed on day 1|1 day|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline and at least one post-baseline measurement before or at Week 12 for the primary endpoint.||liters||Standard Error|Least Squares Mean
683585|NCT01525615|Secondary|Adjusted Mean Slope of the Intensity of Breathing Discomfort After Week 12|"Secondary endpoint was the slope of the intensity of breathing discomfort during constant work rate cycle ergometry to symptom limitation at 75% of maximal work capacity after 12 weeks of treatment.
The intensity of breathing discomfort was rated on the Borg Scale with categories from 0 (nothing at all) to 10 (maximal). The slope of the intensity of breathing discomfort was defined as the Borg scale value of breathing discomfort at the end of exercise minus the Borg scale value of breathing discomfort at pre-exercise divided by the endurance time. A decrease in slope indicates favorable results."|12 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline and at least one post-baseline measurement before or at Week 12 for the primary endpoint.||units / seconds||Standard Error|Least Squares Mean
683586|NCT01525615|Secondary|Adjusted Mean Slope of the Intensity of Breathing Discomfort After Week 6|"Secondary endpoint was the slope of the intensity of breathing discomfort during constant work rate cycle ergometry to symptom limitation at 75% of maximal work capacity after 6 weeks of treatment.
The intensity of breathing discomfort was rated on the Borg Scale with categories from 0 (nothing at all) to 10 (maximal). The slope of the intensity of breathing discomfort was defined as the Borg scale value of breathing discomfort at the end of exercise minus the Borg scale value of breathing discomfort at pre-exercise divided by the endurance time. A decrease in slope indicates favorable results."|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline and at least one post-baseline measurement before or at Week 12 for the primary endpoint.||units / seconds||Standard Error|Least Squares Mean
683587|NCT01525615|Secondary|Adjusted Mean Slope of the Intensity of Breathing Discomfort on Day 1|"Secondary endpoint was the slope of the intensity of breathing discomfort during constant work rate cycle ergometry to symptom limitation at 75% of maximal work capacity after 1 day of treatment.
The intensity of breathing discomfort was rated on the Borg Scale with categories from 0 (nothing at all) to 10 (maximal). The slope of the intensity of breathing discomfort was defined as the Borg scale value of breathing discomfort at the end of exercise minus the Borg scale value of breathing discomfort at pre-exercise divided by the endurance time. A decrease in slope indicates slowing down in decline in breathing, i.e., favorable results."|1 day|Visit 4 Set. All randomized patients dispensed medication, were documented to have taken any dose of study medication, and had evaluable measurements of endurance time at Baseline (Visit 3) and at Visit 4 (Day 1) during CWRCE. Patients were assigned to the Visit 4 set after implementation of data handling rules that set measurements to missing.||units / seconds||Standard Error|Least Squares Mean
683599|NCT01525563|Secondary|Amount of Menstrual Bleeding From Baseline to End of Treatment|Assessment of average number of pads changed per day at baseline and at the end of treatment (EOT).|6 months|The amount of menstrual bleeding (based on no. of pads used per day) was analyzed for all subjects completing EOT and change was noted from baseline to EOT||pads/day||Standard Deviation|Mean
683589|NCT01525615|Secondary|Adjusted Mean Inspiratory Capacity at Pre-exercise After 1 Day|Secondary endpoint was pre-exercise inspiratory capacity (IC) during constant work rate cycle ergometry to symptom limitation at 75% maximal work capacity (Wcap) on Day 1.|1 day|Visit 4 Set. All randomized patients dispensed medication, were documented to have taken any dose of study medication, and had evaluable measurements of endurance time at Baseline (Visit 3) and at Visit 4 (Day 1) during CWRCE. Patients were assigned to the Visit 4 set after implementation of data handling rules that set measurements to missing.||liters||Standard Error|Least Squares Mean
683590|NCT01525615|Secondary|Adjusted Mean Endurance Time During Constant Work Rate Cycle Ergometry (CWRCE) After 6 Weeks Treatment|Secondary endpoint was endurance time during constant work rate cycle ergometry to symptom limitation at 75% of maximal work capacity after 6 weeks of treatment.The endurance time in seconds was transformed using log10 scale to correct skewness in endurance time on original scale and then the MMRM model was fitted to the log10-transformed data and the least square means and SEs were obtained. To present the results in a way easier for interpretation, the least square mean from the MMRM fitted to the log10-transformed data were transformed back taking 10 to the power of the least square estimate for the log10 of geometric mean and the corresponding SE was transformed using delta method to get the corresponding SEs of the geometric mean.|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline and at least one post-baseline measurement before or at Week 12 for the primary endpoint.||seconds||Standard Error|Least Squares Mean
683591|NCT01525615|Secondary|Adjusted Mean Endurance Time During Constant Work Rate Cycle Ergometry (CWRCE) on Day 1|Secondary endpoint was endurance time during constant work rate cycle ergometry to symptom limitation at 75% of maximal work capacity on Day 1. Analysis of covariance model on log10 transformation data. Adjusted means are back transformed to report in original units. Standard errors (SEs) are calculated using the delta method.|1 day|Visit 4 Set. All randomized patients dispensed medication, were documented to have taken any dose of study medication, and had evaluable measurements of endurance time at Baseline (Visit 3) and at Visit 4 (Day 1) during CWRCE. Patients were assigned to the Visit 4 set after implementation of data handling rules that set measurements to missing.||seconds||Standard Error|Least Squares Mean
683592|NCT01525615|Secondary|Adjusted Mean Inspiratory Capacity at Pre-exercise After 12 Weeks|Secondary endpoint was pre-exercise inspiratory capacity (IC) before constant work rate cycle ergometry to symptom limitation at 75% maximal work capacity (Wcap) after 12 weeks of treatment.|12 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline and at least one post-baseline measurement before or at Week 12 for the primary endpoint.||liters||Standard Error|Least Squares Mean
683593|NCT01525615|Secondary|Adjusted Mean Endurance Time During Endurance Shuttle Walk Test (ESWT) After 12 Weeks|Key secondary endpoint was endurance time during endurance shuttle walk test to symptom limitation at 85% of predicted maximum oxygen consumption (VO2) peak after 12 weeks of treatment. The endurance time in seconds was transformed using log10 scale to correct skewness in endurance time on original scale and then the MMRM model was fitted to the log10-transformed data and the least square means and SEs were obtained. To present the results in a way easier for interpretation, the least square mean from the MMRM fitted to the log10-transformed data were transformed back taking 10 to the power of the least square estimate for the log10 of geometric mean and the corresponding SE was transformed using delta method to get the corresponding SEs of the geometric mean.|12 weeks|Endurance shuttle walk test (ESWT) substudy set - This patient set included all patients in the Treated Set who had given informed consent for participating in the ESWT substudy and had a baseline and at least one post-baseline measurement during ESWT before or at Week 12 for the key secondary endpoint.||seconds||Standard Error|Least Squares Mean
683594|NCT01525615|Primary|Adjusted Mean Endurance Time During Constant Work Rate Cycle Ergometry (CWRCE) After 12 Weeks|Primary endpoint was endurance time during constant work rate cycle ergometry to symptom limitation at 75% of maximal work capacity after 12 weeks of treatment. The endurance time in seconds was transformed using log10 scale to correct skewness in endurance time on original scale and then the MMRM model was fitted to the log10-transformed data and the least square means and SEs were obtained. To present the results in a way easier for interpretation, the least square mean from the MMRM fitted to the log10-transformed data were transformed back taking 10 to the power of the least square estimate for the log10 of geometric mean and the corresponding SE was transformed using delta method to get the corresponding SEs of the geometric mean.|12 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline and at least one post-baseline measurement before or at Week 12 for the primary endpoint.||seconds||Standard Error|Least Squares Mean
683595|NCT01525563|Secondary|Overall Clinical Response|Overall response (on a 7 point Clinical Global Impression of Severity scale, where 1 = Normal, not at all ill, 2 = Borderline ill, 3 = Mildly ill, 4 = Moderately ill, 5 = Markedly ill, 6 = Severely ill, 7 = Most extremely ill) at the EOT by assessing percentages of patients in each category at the EOT.|6 months|Overall response (on a 7 point Clinical Global Impression of Severity scale, where 1 = Normal, not at all ill, 2 = Borderline ill, 3 = Mildly ill, 4 = Moderately ill, 5 = Markedly ill, 6 = Severely ill, 7 = Most extremely ill) at the EOT by assessing percentages of patients in each category at the EOT.||participants|||Number
683596|NCT01525563|Secondary|Evolution of Duration of Menstrual Bleeding From Baseline to End of Treatment|To observe the evolution of duration of menstrual bleeding from baseline to end of treatment by assessing mean duration of menstrual bleeding (in days) at baseline and at the end of treatment.|6 months|To observe the evolution of duration of menstrual bleeding from baseline (all enrolled) to end of treatment by assessing mean duration of menstrual bleeding (in days) at baseline and at the end of treatment (EOT).||Days||Standard Deviation|Mean
683597|NCT01525563|Secondary|Overall Patient Satisfaction|The overall patient satisfaction was recorded on a 5 point Clinical Global Impression of Severity scale, where 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat satisfied, 4 = satisfied, 5 = very satisfied).|6 months|Overall at the EOT, of 910 patients population the overall satisfaction was assessed||participants|||Number
683598|NCT01525563|Secondary|Evolution of Pain During Menstruation From Baseline to End of Treatment|The scores for pain during menstruation were recorded on 11-point Likert scale on baseline and end of treatment where 0 means no pain, and 10 means worst pain.|6 months|The scores for pain during menstruation were recorded on 11-point Likert scale on baseline for all enrolled subjects and end of treatment where 0 means no pain, and 10 means worst pain.||participants|||Number
683600|NCT01525563|Secondary|Change in Cycle Duration (in Days) From Baseline to End of Treatment (EOT)|The evolution of cycle duration from baseline to EOT was assessed by mean cycle duration (in days) at baseline, separately in polymenorrhea and oligomenorrhea groups, and at the EOT. The patients were included in polymenorrhea group in case the cycle duration at baseline was less than 21 days and in oligomenorrhea group in case the cycle duration at baseline was greater than 35 days.|6 months|All patients were assessed for overall reduction in cycle duration (910).||Days||Standard Deviation|Mean
683601|NCT01525563|Primary|Percentage of Patients Reporting a Regular Cycle|Regular cycle is defined as cycle duration between 21 to 35 days, inclusive at the end of treatment period.|6 months|Intent-to-Treat Population||percentage of participants||95% Confidence Interval|Number
683602|NCT01525550|Secondary|Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)|ECOG-PS performance status is used to assess how the disease affects the daily living abilities of the participant. It was measured on 6-point scale ranging from 0-5, where 0= fully active/able to carry on all pre-disease activities without restriction; 1= restricted in physically strenuous activity but ambulatory/able to carry out light or sedentary work; 2= ambulatory for more than 50 percent of waking hours and capable of all self-care but unable to carry out any work activities; 3= capable of limited self-care, confined to bed or chair >50 percent of waking hours; 4= completely disabled, not capable of any self-care, totally confined to bed or chair; 5= dead. A higher score indicated greater functional impairment. Only those ECOG-PS categories, in which at least one participant had data at any indicated time point were reported in this outcome measure. Not reported (NR) category included participants with unavailable ECOG performance status.|Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, End of treatment (up to maximum duration of 1226 days)|Safety analysis set included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.||participants|||Number
683603|NCT01525550|Secondary|Number of Participants With Change From Baseline in Body Weight|Participants with increase of >=5 percent and decrease of >=5 percent from baseline in body weight were reported in this outcome measure.|Baseline up to 1226 days|Safety analysis set included all participants who received at least 1 dose of study medication.||participants|||Number
683604|NCT01525550|Secondary|Number of Participants With Change From Baseline in Physical Examinations Findings|Physical examination included an examination of the general appearance, skin, heart, head, eyes, ears, nose, throat, breasts, abdomen, musculoskeletal, neck, extremities, thyroid and others.|Baseline up to 1226 days|Safety analysis set included all participants who received at least 1 dose of study medication.||participants|||Number
683605|NCT01525550|Secondary|Number of Participants With Increase From Baseline in Corrected QT Interval (QTc)||Baseline up to 1226 days|Safety analysis set included all participants who received at least 1 dose of study medication.||participants|||Number
683606|NCT01525550|Secondary|Number of Participants With Change From Baseline in Vital Signs Abnormalities|Following parameters were analyzed for examination of vital signs: systolic and diastolic blood pressure, body temperature and heart rate.|Baseline up to 1226 days|Safety analysis set included all participants who received at least 1 dose of study medication.||participants|||Number
683607|NCT01525550|Secondary|Number of Participants With Clinically Significant Laboratory Abnormalities|Following parameters were analyzed for laboratory examination: hematology (hemoglobin, red blood cell count, platelet count, white blood cell count, total neutrophils, basophils, lymphocytes); liver function (aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, albumin, total protein); renal function (blood urea nitrogen, creatinine); electrolytes (sodium, potassium, chloride, calcium, magnesium, phosphate); urinalysis (urine protein), miscellaneous (pregnancy test, Chromogranin A). Clinically significant laboratory abnormalities were identified by the Investigator.|Baseline up to 1226 days|Safety analysis set included all participants who received at least 1 dose of study medication.||participants|||Number
683608|NCT01525550|Secondary|Number of Participants With Adverse Events (AEs) According to Severity|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed according to severity grading based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events [CTCAE] Version 3.0. Grade 1 =mild; Grade 2 =moderate; within normal limits, Grade 3 =severe or medically significant but not immediately life-threatening; Grade 4 =life-threatening or disabling; urgent intervention indicated; Grade 5 =death.|Baseline up to 1226 days|"Safety analysis set included all participants who received at least 1 dose of study medication. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure."||participants|||Number
683609|NCT01525550|Secondary|Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)|Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 1226 days that were absent before treatment or that worsened relative to pre-treatment state. Relatedness to study drug was assessed by the investigator.|Baseline up to 1226 days|Safety analysis set included all participants who received at least 1 dose of study medication.||participants|||Number
683610|NCT01525550|Secondary|Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 1226 days that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs.|Baseline up to 1226 days|Safety analysis set included all participants who received at least 1 dose of study medication.||participants|||Number
683611|NCT01525550|Secondary|Half Maximal Effective Concentration (EC50) of Sunitinib|Concentration of sunitinib in plasma at which 50 percent of the maximum effect was observed.|Pre dose on Day 15 of Cycle 1, Day 1 of Cycle 2, 3 and 5 (each cycle 28 days)||||||
683613|NCT01525550|Secondary|Area Under the Curve (AUC24) of Sunitinib and Its Metabolite SU012662|Area under the plasma concentration-time profile from time zero (pre-dose) to 24 hours post-dose. SU012662 is the metabolite of sunitininb.|Pre-dose (0 hour) and at multiple time points (up to 24 hours) post dose on Day 15 of Cycle 1, Day 1 of Cycle 2, 3 and 5 (each cycle 28 days)||||||
683614|NCT01525550|Secondary|Dose-Corrected Trough Plasma Concentration of Sunitinib and Its Metabolite SU012662|Dose-corrected plasma trough concentration is calculated as: trough plasma concentration*(intended dose divided by actual dose). Intended dose was defined as the starting dose in the study and actual dose was defined as the last dose which the participant had received. SU012662 is the metabolite of sunitininb.|Pre dose on Day 15 of Cycle 1, Day 1 of Cycle 2, 3 and 5|PK population included all participants who received at least 1 dose of study medication, had baseline and at least 1 post-baseline value for each parameters. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.||ng/mL||Standard Deviation|Mean
683615|NCT01525550|Secondary|Plasma Concentration (Ctrough) of Sunitinib and Its Metabolite SU012662|Ctrough is the minimum observed plasma concentration of drug. SU012662 is the metabolite of sunitinib.|Pre-dose on Day 15 of Cycle 1, Day 1 of Cycle 2, 3 and 5|Pharmacokinetic (PK) population included all participants who received at least 1 dose of study medication, had baseline and at least 1 post-baseline value for each parameters. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
683616|NCT01525550|Secondary|Plasma Concentration of Soluble Protein Biomarker (sKIT)||Pre-dose on Day 1 and 15 of Cycle 1, Day 1 of Cycle 2, 3 and every 2 cycles thereafter (Cycle 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, 37, 39, 41, 43), End of Treatment (up to 1226 days)|sKIT analysis set included all enrolled participants who received at least 1 dose of study drug and had at least 1 biomarker parameter from the corresponding assay sample with both a baseline and post-treatment assessment. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.||picogram per milliliter (pcg/mL)||Standard Deviation|Mean
683617|NCT01525550|Secondary|Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)|EORTC QLQ-GI-NET 21 was a 21-item questionnaire. These 21 questions assesses endocrine symptoms, gastrointestinal (G.I.) symptoms, treatment related symptoms, social functioning, disease related worries, muscle/bone pain, sexual function, information/communication function and body image. Each item was answered on a 4-point scale: 1 =not at all, 2 =a little, 3 =quite a bit, 4 =very much; where higher scores indicated more severe symptoms/problems. Scores averaged, transformed to 0-100 scale; higher score=more severe symptoms.|Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, End of treatment (up to maximum duration of 1226 days)|FAS included all participants who were enrolled into the study regardless of whether participants received study drug or not. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.||units on a scale||Standard Deviation|Mean
683618|NCT01525550|Secondary|Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)|EORTC QLQ-C30 is a cancer-specific instrument with 30 questions to assess the participant quality of life. First 28 questions used for evaluating 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, nausea and vomiting, pain) and other single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulties). Each question was assessed on 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much); high score represented high level of symptomatology/problem. Last 2 questions used for evaluating global health status (GHS)/quality of life. Each question was assessed on 7-point scale (1=very poor to 7=excellent). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning.|Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, End of treatment (up to maximum duration of 1226 days)|FAS included all participants who were enrolled into the study regardless of whether participants received study drug or not. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.||units on a scale||Standard Deviation|Mean
683619|NCT01525550|Secondary|Percentage of Participants With Chromogranin A (CgA) Response|CgA response in participants was defined as having confirmed CgA CR or CgA PR, relative to the population with an elevated baseline CgA value in the blood. CgA CR was defined as decrease from a high baseline value of CgA in the blood to one that fell within the normal range. CgA PR was defined as a decrease of greater than or equal to 50 percent from a high baseline value of CgA. Normal baseline value of CgA in blood was 39.0 ng/mL. Confirmed responses were those that persisted for at least 4 weeks after initial documentation of response. Blood levels of CgA were assessed and percentage of participants with CgA response were reported.|Baseline until CgA response or death due to any cause (up to 1226 days)|FAS included all participants who were enrolled into the study regardless of whether participants received study drug or not.||percentage of participants||95% Confidence Interval|Number
683620|NCT01525550|Secondary|Time to Tumor Response (TTR): Independent Radiological Review (IRR) Assessment|IRR assessed TTR was defined as the time (in months) from date of enrollment in study until first documentation of objective tumor response (CR or PR) that was subsequently confirmed. TTR was calculated as (first response date minus the date of enrollment plus 1) divided by 30.4. According to Choi criteria, CR was defined as disappearance of all target and non-target lesions and no new lesions. PR was defined as a decrease of >=10 percent in tumor size or a decrease in tumor density (HU) of 15 percent or more on CT with no new lesions and no obvious progression of non-measurable disease.|Baseline until first documented objective tumor response (up to 1226 days)|FAS included all participants who were enrolled into the study regardless of whether participants received study drug or not.||months||Full Range|Median
683646|NCT01525238|Secondary|Number of Participants With Vital Sign Abnormalities, Electrocardiogram (ECG) Abnormalities, or Physical Examination Abnormalities Following Study Drug Administration.|Participants were followed from dosing on Day 1 until study discharge on Day 3. The number of participants with investigator-assessed clinically-important abnormalities in vital sign measurements, ECGs or physical examinations was reported.|Day 1 to Day 3|All treated participants||participants|||Number
683621|NCT01525550|Secondary|Duration of Response (DOR): Independent Radiological Review (IRR) Assessment|IRR assessed DOR was defined as the time (in months) from the date of first documented objective tumor response (CR or PR) that was subsequently confirmed to the first documented objective tumor progression or death due to any cause, whichever occurred first. According to Choi criteria, CR was defined as disappearance of all target and non-target lesions and no new lesions. PR was defined as a decrease of >=10 percent in tumor size or a decrease in tumor density (HU) of 15 percent or more on CT with no new lesions and no obvious progression of non-measurable disease.|Baseline until disease progression or death due to any cause (up to 1226 days)|FAS included all participants who were enrolled into the study regardless of whether participants received study drug or not.||months||95% Confidence Interval|Median
683622|NCT01525550|Secondary|Percentage of Participants With Objective Response (OR): Independent Radiological Review (IRR) Assessment|IRR assessed OR in participants was defined as having a CR or PR according to Choi criteria and sustained for at least 4 weeks. According to Choi criteria, CR was defined as disappearance of all target and non-target lesions and no new lesions. PR was defined as a decrease of >=10 percent in tumor size or a decrease in tumor density (HU) of 15 percent or more on Computed tomography (CT) with no new lesions and no obvious progression of non-measurable disease. Percentage of participants with objective response were reported in this outcome measure.|Baseline until disease progression or death due to any cause (up to 1226 days)|FAS included all participants who were enrolled into the study regardless of whether participants received study drug or not.||percentage of participants||95% Confidence Interval|Number
683623|NCT01525550|Secondary|Time to Tumor Response (TTR): Investigator Assessment|Investigator assessed TTR was defined as the time (in months) from date of enrollment in study until date of first documentation of objective tumor response (CR or PR) that was subsequently confirmed. TTR was calculated as (first response date minus the date of enrollment plus 1) divided by 30.4. As per RECIST 1.0, CR was defined as disappearance of all target and non-target lesions and PR was defined as >=30 percent decrease in the sum of the LD of the target lesions taking as a reference the baseline sum LD.|Baseline until first documented objective tumor response (up to 1226 days)|FAS included all participants who were enrolled into the study regardless of whether participants received study drug or not.||months||Full Range|Median
683624|NCT01525550|Secondary|Duration of Response (DOR): Investigator Assessment|Investigator assessed DOR was defined as the time (in months) from the date of first documented objective tumor response (CR or PR), that was subsequently confirmed, to the first documented objective tumor progression or death due to any cause, whichever occurred first. According to RECIST 1.0, CR was defined as disappearance of all target and non-target lesions. PR was defined as >=30 percent decrease in the sum of the LD of the target lesions taking as a reference the baseline sum LD. Progression as per RECIST version 1.0 was defined as >=20 percent increase in sum of LD of target lesions taking as a reference the smallest sum of the LD recorded since the treatment started, or the appearance of one or more new lesions and/or unequivocal progression of existing non target-lesions.|Baseline until disease progression or death due to any cause (up to 1226 days)|FAS included all participants who were enrolled into the study regardless of whether participants received study drug or not.||months||95% Confidence Interval|Median
683625|NCT01525550|Secondary|Percentage of Participants With Objective Response (OR): Investigator Assessment|Investigator assessed OR in participants was defined as having a complete response (CR) or partial response (PR) according to RECIST 1.0 and sustained for at least 4 weeks. CR was defined as disappearance of all target and non-target lesions. PR was defined as >=30 percent decrease in the sum of the LD of the target lesions taking as a reference the baseline sum LD. Percentage of participants with investigator assessed OR were reported.|Baseline until disease progression or death due to any cause (up to 1226 days)|FAS included all participants who were enrolled into the study regardless of whether participants received study drug or not.||percentage of participants||95% Confidence Interval|Number
683626|NCT01525550|Secondary|Overall Survival (OS)|OS was defined as the time (in months) from date of enrollment in study to the date of death due to any cause. If death was not observed, the participant was censored at the earliest of the last date the participant was known to be alive or the study cut-off date. The analysis was performed by Kaplan-Meier method.|Baseline until death or study cut-off (up to 5 years)|FAS included all participants who were enrolled into the study regardless of whether participants received study drug or not.||months||95% Confidence Interval|Median
683627|NCT01525550|Secondary|Time to Tumor Progression (TTP): Investigator Assessment|Investigator assessed TTP was defined as the time (in months) from the date of enrollment in study until the date of first documentation of objective tumor progression. TTP calculated as (first event date minus date of enrollment plus 1)/30.4. Progression as per RECIST 1.0 was defined as >=20 percent increase in sum of LD of target lesions taking as a reference the smallest sum of the LD recorded since the treatment started, or the appearance of one or more new lesions and/or unequivocal progression of existing non target-lesions. The analysis was performed by Kaplan-Meier method.|Baseline until first documented tumor progression (up to 1226 days)|FAS included all participants who were enrolled into the study regardless of whether participants received study drug or not.||months||95% Confidence Interval|Median
683628|NCT01525550|Secondary|Progression-Free Survival (PFS): Independent Radiological Review (IRR) Assessment|IRR assessed PFS was defined as the time (in months) from the date of enrollment in study until the date of first documented objective tumor progression or death (due to any cause), whichever occurs first in the absence of progression. PFS calculated as (first event date minus date of enrollment plus 1)/30.4. If progression or death was not observed, the participant was censored at the date of the participant’s last progression-free tumor assessment prior to the study cut-off date. Progression as per RECIST 1.0 criteria was defined as: >=20 percent increase in sum of LD of target lesions taking as a reference the smallest sum of the LD recorded since the treatment started, or the appearance of one or more new lesions and/or unequivocal progression of existing non target-lesions. The analysis was performed by Kaplan-Meier method.|Baseline until disease progression or death due to any cause (up to 1226 days)|FAS included all participants who were enrolled into the study regardless of whether participants received study drug or not.||months||95% Confidence Interval|Median
683647|NCT01525238|Secondary|Mean Total Amount of Glucose Excreted in Urine Over 24 Hours|The total amount of glucose excreted in urine was measured for 24 hours following administration of Dapagliflozin. Means are reported in grams.|Time of dose to 24 hours post-dose, Day 1 to Day 2|All treated participants with evaluable PD profiles||grams||Standard Deviation|Mean
683629|NCT01525550|Primary|Progression-Free Survival (PFS): Investigator Assessment|Investigator assessed PFS was defined as the time (in months) from the date of enrollment in study to the date of first documented objective tumor progression or death (due to any cause), whichever occurs first in the absence of progression. PFS calculated as (first event date minus date of enrollment plus 1)/30.4. If progression or death was not observed, the participant was censored at the date of the participant’s last progression-free tumor assessment prior to the study cut-off date. Progression as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 criteria was defined as: greater than or equal to (>=) 20 percent increase in sum of longest diameter (LD) of target lesions taking as a reference the smallest sum of the LD recorded since the treatment started, or the appearance of one or more new lesions and/or unequivocal progression of existing non target-lesions. The analysis was performed by Kaplan-Meier method.|Baseline until disease progression or death due to any cause (up to 1226 days)|FAS included all participants who were enrolled into the study regardless of whether participants received study drug or not.||months||95% Confidence Interval|Median
683630|NCT01525420|Secondary|7-day and 24-hour Point Prevalence Quit Rates|7-day and 24-hour point prevalence quit rates|6-month||||||
683631|NCT01525420|Primary|Number of Participants Who Stopped Smoking by 6 Month Post Treatment|30-Day point prevalence abstinence at 6 months post treatment|6 months|||participants|||Number
683632|NCT01525407|Secondary|Recurrent or Progressive Malignancy|Cumulative incidence rate of recurrent or progressive malignancy with death as a competing risk, assessed at 3 years in the patients/recipients.|Up to 3 years|||probability||95% Confidence Interval|Number
683633|NCT01525407|Secondary|Proportion of Patients Requiring Secondary Systemic Immunosuppressive Therapy||First 100 days after transplant|||Participants|||Count of Participants
683634|NCT01525407|Secondary|Proportion of Donors Who Have to Discontinue Atorvastatin Because of Toxicity||Until completion of stem cell collection (on average 14 days)|||Participants|||Count of Participants
683635|NCT01525407|Secondary|Overall Survival|Determined and presented as Kaplan-Meier estimates, assessed at 1 year in the patients/recipients.|1 year after transplant|||survival probability||95% Confidence Interval|Number
683636|NCT01525407|Secondary|Non-relapse Mortality|Cumulative incidence rate of non-relapse mortalities, assessed at one year in the patients/recipients.|At 1 year after HCT|||probability||95% Confidence Interval|Number
683637|NCT01525407|Secondary|Non-relapse Mortality|Cumulative incidence rate of non-relapse mortalities, assessed at day 100 in the patients/recipients.|At day 100|||probability||95% Confidence Interval|Number
683638|NCT01525407|Secondary|Grades II-IV Acute GVHD|Cumulative incidence rate of grades II-IV acute GVHD with death as a competing risk, assessed at 100 days in the patients/recipients.|First 100 days after transplant|||probability||95% Confidence Interval|Number
683639|NCT01525407|Secondary|Disease-free Survival|Evaluated as Kaplan-Meier estimate in the patients/recipients.|1 year after transplant|||disease free survival probability||95% Confidence Interval|Number
683640|NCT01525407|Secondary|Chronic Extensive GVHD|Cumulative incidence rate of chronic extensive GVHD with death as a competing risk, assessed at 2 years in the patients/recipients.|2 years post transplant|||probability||95% Confidence Interval|Number
683641|NCT01525407|Primary|Grade 3-4 Acute GVHD|Cumulative incidence rate of grade 3-4 acute GVHD with death as a completing risk, assessed at day 100 in the patients/recipients.|First 100 days after transplant|||probability||95% Confidence Interval|Number
683642|NCT01525238|Secondary|Number of Participants With Marked Urinalysis Abnormalities|LLN=Lower Limit of Normal, ULN=Upper Limit of Normal, Pre-Rx=Value before first dose. Lab values that met the following criteria were marked as abnormalities: Blood, urine (Qualitative): >=2 (If Pre-Rx >= 1, >=2*Pre-Rx). Glucose, urine (Qualitative): >=1, (If Pre-Rx >=1, >=2*Pre-Rx). Protein, urine (Qualitative): >=2 (If Pre-Rx >=1, >=2*Pre-Rx). Red Blood Cells (RBC), urine (RBC per High Power Field (hpf)): >=2 (If Pre-Rx>=2, >=4). White Blood Cells (WBC), urine (hpf): >=2 (If Pre-Rx>=2, >=4).|Day 1 (Pre-dose) to Day 3|All treated participants with evaluable lab results||participants|||Number
683643|NCT01525238|Secondary|Number of Participants With Marked Abnormalities in Other Chemistry Testing|LLN=Lower Limit of Normal, ULN=Upper Limit of Normal, Pre-Rx=Value before first dose. Lab values that met the following criteria were marked as abnormalities: Glucose, fasting serum (mmol/L): <0.8*LLN, >1.3*ULN (if Pre-Rx<LLN: <0.8*Pre-Rx, >ULN. If Pre-Rx>ULN: >2.0*Pre-Rx, <LLN). Protein (grams per deciliter: g/L): <0.9*LLN, >1.1*ULN (if Pre-Rx<LLN: <0.9*Pre-Rx, >ULN. If Pre-Rx>ULN: >1.1*Pre-Rx, <LLN). Albumin (g/L): <0.9*LLN (if Pre-Rx<LLN: <0.9*Pre-Rx). Uric Acid (mmol/L): >1.2*ULN (if Pre-Rx>ULN: >1.25*Pre-Rx). Lactate Dehydrogenase (U/L): >1.25*ULN (if Pre-Rx>ULN: >1.5*Pre-Rx)|Day 1 (Pre-dose) to Day 3|All treated participants||participants|||Number
683644|NCT01525238|Secondary|Number of Participants With Marked Serum Chemistry Abnormalities|LLN=Lower Limit of Normal, ULN=Upper Limit of Normal, Pre-Rx=Value before first dose. Lab values that met the following criteria were marked as abnormalities: Alkaline Phosphatase (units per liter: U/L), Aspartate Aminotransferase (U/L), Alanine Aminotransferase (U/L): >1.25*ULN (if Pre-Rx>ULN, use >1.25*Pre-Rx). Bilirubin (milligrams per deciliter: mg/dL): >1.1*ULN (if Pre-Rx>ULN, use >1.25*Pre-Rx). Blood Urea Nitrogen (mg/dL): >1.1*ULN (if Pre-Rx>ULN, use >1.2*Pre-Rx). Creatinine (micromoles per Liter (umol/L)): >1.5*ULN if Pre-Rx missing or <= ULN, >1.33*Pre-Rx if PreRx > ULN. Sodium (mmol/L): >1.05*ULN, 1.05*Pre-Rx if Pre-Rx>ULN: <0.95*Pre-Rx, >ULN. If Pre-Rx>ULN: >1.05*Pre-Rx, <LLN). Potassium(mmol/L), Chloride (mmol/L), Calcium(mmol/L): <0.9*LLN, >1.1*ULN (if Pre-Rx<LLN: <0.9*Pre-Rx, >ULN. If Pre-Rx>ULN: >1.1*Pre-Rx, <LLN). Phosphorus (mg/dL): <0.85*LLN, >1.25*ULN (if Pre-Rx<LLN, <0.85*Pre-Rx, >ULN. if Pre-Rx>ULN: >1.25*Pre-Rx, <LLN).|Day 1 (Pre-dose) to Day 3|All treated participants||participants|||Number
683645|NCT01525238|Secondary|Number of Participants With Marked Hematology Laboratory Abnormalities|LLN=Lower Limit of Normal, ULN=Upper Limit of Normal, Pre-Rx=Value before first dose (Day -1). Lab values that met the following criteria were marked as abnormalities: Hemoglobin (grams per deciliter:g/dL): <0.85*Pre-Rx. Hematocrit (%): <0.85*Pre-Rx. Platelet Count (x10^9 cells per liter:c/L): <0.85*LLN or >1.5*ULN (if Pre-Rx<LLN, use <0.85*Pre-Rx). Leukocytes (x10^3 cells per microliter: c/uL): <0.9*LLN, >1.2*ULN (if Pre-Rx<LLN, use <0.85*Pre-Rx or >ULN, if Pre- Rx>ULN, use >1.15*Pre-Rx or <LLN). Neutrophils (Absolute) (x10^3 c/uL): <=1.5. Lymphocytes (Absolute) (x10^3 c/uL): <0.75 or >7.5. Monocytes (Absolute) (x10^3 c/uL): >2.000. Basophils (x10^3 c/uL): >0.4. Eosinophils (Absolute) (x10^3 c/uL): >0.75. Blasts (Absolute) (x10^9 c/L) > 0.|Day 1 (Pre-dose) to Day 3|All treated participants||participants|||Number
683648|NCT01525238|Secondary|Mean Change in Fasting Plasma Glucose From Baseline Until Day 2|Plasma glucose concentrations were evaluated in all treated subjects at Day 1 pre-dose and at Day 2 after fasting for 8 hours. Mean change from baseline to Day 2 is reported in milligrams per deciliter (mg/dL).|Day 1 (Pre-dose) to Day 2|All treated participants with evaluable PD profiles||mg/dL||Standard Deviation|Mean
683649|NCT01525238|Secondary|Mean Fasting Plasma Glucose Concentrations at Pre-dose on Day 1 and on Day 2 After an 8-hr Fasting|Plasma glucose concentrations were evaluated in all treated subjects at Day 1 pre-dose and at Day 2 after fasting for 8 hours. Means are reported in milligrams per deciliter (mg/dL).|Day 1 (Pre-dose) to Day 2|All treated participants with evaluable pharmacodynamic (PD) profiles||mg/dL||Standard Deviation|Mean
683650|NCT01525238|Secondary|Mean Plasma Half-life (T-HALF) of Dapagliflozin 3-O-Glucuronide|Plasma half-life (T-Half) for Dapagliflozin was derived from plasma concentration versus time data. Means are reported in hours.|11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose|All treated participants with evaluable PK profiles||hours||Standard Deviation|Mean
683651|NCT01525238|Secondary|Geometric Mean of Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] of Dapagliflozin 3-O-Glucuronide|Area under the concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)) was measured by plasma concentration of Dapagliflozin 3-O-Glucuronide over time. The geometric means are reported in nanogram hours per milliliter (ng*h/mL).|11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose|All treated participants with evaluable PK profiles||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
683652|NCT01525238|Secondary|Geometric Mean of Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of Dapagliflozin 3-O-Glucuronide|Area under the plasma concentration-time curve from time zero extrapolated to infinite time was derived from concentration versus time data. Geometric means are reported in nanogram hours per milliliter (ng*hr/mL).|11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose|All treated participants with evaluable PK profiles||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
683653|NCT01525238|Secondary|Median Time of Maximum Observed Plasma Concentration (Tmax) of Dapagliflozin 3-O-Glucuronide|Time of maximum observed plasma concentration (Tmax) for Dapagliflozin 3-O-Glucuronide was derived from plasma concentrations versus time data. Medians were reported in hours (h).|11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose|All treated participants with evaluable PK profiles||hours||Full Range|Median
683654|NCT01525238|Secondary|Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Dapagliflozin 3-O-Glucuronide|Maximum observed plasma concentration (Cmax) was measured by plasma concentration of Dapagliflozin 3-O-Glucuronide over time. The geometric means are reported in nanograms per milliliter (ng/mL).|11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose|All treated participants with evaluable PK profiles||ng/mL||Geometric Coefficient of Variation|Geometric Mean
683655|NCT01525238|Primary|Geometric Mean of Apparent Volume of Distribution at Terminal Phase After Extravascular Administration (Vz/F) of Dapagliflozin|Geometric mean of apparent volume of distribution at terminal phase after extravascular administration of Dapagliflozin was derived from plasma concentration versus time data. Geometric means are reported in Liters (L)|11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose|All treated participants with evaluable PK profiles||Liters||Geometric Coefficient of Variation|Geometric Mean
683656|NCT01525238|Primary|Geometric Mean of Apparent Clearance After Extravascular Administration (CL/F) of Dapagliflozin|Apparent clearance after extravascular administration (CL/F) of Dapagliflozin was derived from plasma concentrations versus time data. Geometric means are reported in milliliters per minute (mL/min).|11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose|All treated participants with evaluable PK profiles||mL/min||Geometric Coefficient of Variation|Geometric Mean
683657|NCT01525238|Primary|Mean Plasma Half-life (T-HALF) of Dapagliflozin|Plasma half-life (T-Half) for Dapagliflozin was derived from plasma concentrations versus time data. Means are reported in hours.|11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose|All treated participants with evaluable PK profiles||hours||Standard Deviation|Mean
683658|NCT01525238|Primary|Geometric Mean of Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] of Dapagliflozin|Area under the concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)) was measured by plasma concentration of Dapagliflozin over time. The geometric means are reported in nanogram hours per milliliter (ng*h/mL).|11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose|All treated participants with evaluable PK profiles||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
683659|NCT01525238|Primary|Geometric Mean of Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of Dapagliflozin|Area under the plasma concentration-time curve from time zero extrapolated to infinite time was derived from concentration versus time data. Geometric means are reported in nanogram hours per milliliter (ng*hr/mL).|11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose|All treated participants with evaluable PK profiles||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
683660|NCT01525238|Primary|Median Time of Maximum Observed Plasma Concentration (Tmax) of Dapagliflozin|Time of maximum observed plasma concentration (Tmax) for Dapagliflozin was derived from plasma concentrations versus time data. Medians were reported in hours (h).|11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose|All treated participants with evaluable PK profiles.||hours||Full Range|Median
683661|NCT01525238|Primary|Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Dapagliflozin|Maximum observed plasma concentration (Cmax) was measured by plasma concentration of Dapagliflozin over time. The geometric means are reported in nanograms per milliliter (ng/mL).|11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose|All treated participants with evaluable pharmacokinetic (PK) profiles||ng/mL||Geometric Coefficient of Variation|Geometric Mean
683764|NCT01523366|Secondary|AR-C124910XX (an Active Metabolite of Ticagrelor) Plasma Concentrations After the Loading and Maintenance Doses|The SD is a statistic using the log-transformed data and is not the geometric SD.|Predose, 0.5, 2, 8 hours from loading dose; 0, 2, 8 and 12 hours from last dose|PK Analysis Set||ng/mL||Standard Deviation|Geometric Mean
683662|NCT01525225|Secondary|Number of Participants With Marked Chemistry or Hematology Laboratory Abnormalities|Lower limit of normal (LLN); upper limit of normal (ULN); treatment (RX); pre-treatment (Pre-Rx); units per liter (U/L); millimoles per liter (mmol/L). Alkaline phosphatase U/L:>1.25*Pre-RX if Pre-RX >ULN or >1.25*ULN if Pre-RX <=ULN; aspartate aminotransferase U/L: >1.25*Pre-RX if Pre-RX>ULN or 1.25*ULN if Pre-RX<=ULN;alanine aminotransferase U/L: >1.25*Pre-RX if Pre-RX>ULN or 1.25*ULN if Pre-RX<=ULN;blood urea nitrogen mmol/L: >1.1*ULN if Pre-RX <=ULN or >1.2*Pre-RX if Pre-RX >ULN; total bilirubin µmol/L: >1.1*ULN if Pre-RX <=ULN or >1.25*Pre-RX if Pre-RX >ULN; creatine phosphokinase U/L: >1.5*Pre-RX if Pre-RX>ULN or >1.5*ULN if Pre-RX <= ULN. Grams per liter (g/L); cells per liter (c/L). Hemoglobin (g/L): <0.85* pre-RX; hematocrit (%): <0.85*pre-RX;erythrocytes (*10^12 c/L): <0.85*pre-RX; platelet count (*10^9 c/L): <0.85*LLN if pre-RX>=LLN, or if Pre-Tx <LLN; leukocytes (*10^9 c/L): <0.85*LLN if pre-RX <LLN,or <0.9*LLN if LLN<=Pre-RX<=ULN.|Day 1 to Day 8|Participants who received at least one dose of study drug.||participants|||Number
683663|NCT01525225|Primary|Number of Participants With Adverse Events (AEs) , Serious Adverse Events (SAEs), AEs Leading to Discontinuation, Death|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug.|Day 1 up to Day 8, plus 30 days|All participants who received at least one dose of study drug.||participants|||Number
683664|NCT01525173|Primary|Change From Baseline in Mean Diurnal Intraocular Pressure (IOP)|IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the study eye, defined as the worse eye at Baseline. The mean diurnal IOP is the average of all the IOP measurements in the study eye taken at 8 AM, 10 AM and 4 PM at Baseline and at Week 12. A negative change from Baseline indicated improvement.|Baseline, Week 12|Per protocol population included all qualified participants who completed three months of treatment.||mm Hg||Standard Deviation|Mean
683665|NCT01524913|Secondary|Jaw Function Limitation Scale (JFLS) Score|"The Jaw Function Limitation Scale (JFLS) is an 8 item survey where respondents indicate the presence or absence of problems with chewing, drinking, eating hard food, eating soft food, smiling or laughing, yawning, swallowing, and talking. Responses of no are scored as 0 and responses of yes are scored as 1. The total score categorizes jaw limitation as: none (0), mild (1-3), moderate (4-6), and severe (7-8)."|Month 3|The population at this time point consists of study participants who received the intervention they were randomized to, were not lost to follow-up before the Month 3 visit, and completed assessments at the Month 3 visit (one participant did not provide JFLS data at the Month 3 time point).||Participants|||Count of Participants
683666|NCT01524913|Secondary|Jaw Function Limitation Scale (JFLS) Score|"The Jaw Function Limitation Scale (JFLS) is an 8 item survey where respondents indicate the presence or absence of problems with chewing, drinking, eating hard food, eating soft food, smiling or laughing, yawning, swallowing, and talking. Responses of no are scored as 0 and responses of yes are scored as 1. The total score categorizes jaw limitation as: none (0), mild (1-3), moderate (4-6), and severe (7-8)."|Month 1|The population at this time point consists of study participants who received the intervention they were randomized to and were not lost to follow-up before the Month 1 visit.||Participants|||Count of Participants
683667|NCT01524913|Secondary|Change in Maximum Incisal Opening (MIO) Between Baseline, Month 1, and Month 3|Range of motion was assessed at Baseline (preoperatively) and again at Months 1 and 3 using a millimeter ruler for maximum incisal opening. MIO was measurements were taken for maximum opening without and with pain.|Baseline (preoperation), Month 1, Month 3|The population for MIO analysis consists of participants having a measurement at each specified time point. The decline in the number of participants over time is due to participants who were lost to follow-up as the study progressed and one participant who attended the Month 3 visit but did not provide data for the MIO assessment.||millimeters||Standard Deviation|Mean
683668|NCT01524913|Primary|Change in Pain Between Baseline and Month 1 Scores|The change in pain level was assessed using a single-item visual analogue pain scale at Baseline (preoperatively) and at Month 1. Participants indicate their level on pain on a scale of 0 (no pain) to 10 (worst pain imaginable). The right and left side of each participant's jaw was evaluated separately. The change in pain score was obtained by subtracting the Month 1 score from the Baseline score and a negative value indicates a reduction in pain level.|Baseline (preoperation), Month 1|The population at this time point consists of study participants who received their assigned intervention and were not lost to follow up by the Month 1 assessment.||units on a scale||Standard Deviation|Mean
683669|NCT01524900|Primary|Number of Patients Reporting Hepatic Events|Number of patients reporting hepatic events either as adverse event (AE) or as laboratory abnormality of Grade 1 to Grade 4 in aspartate aminotransferase (AST), alanine transaminase (ALT), Gamma-Glutamyl-Transferase (Gamma-GT) and bilirubin.|up to 72 weeks|||participants|||Number
683670|NCT01524900|Primary|Number of Patients Reporting Rash of Any Severity|Number of patients reporting rash of any severity as adverse event|up to 72 weeks|Patients TS||participants|||Number
683671|NCT01524900|Secondary|Number of Patients Reporting Once Daily Nevirapine Intake More Convenient Than Twice Daily Formulation|The number of patients reporting that they find the once daily nevirapine intake more / very much more convenient than the twice daily formulation.|24 weeks|Patients from FAS||participants|||Number
683672|NCT01524900|Secondary|Change in Morisky Medication Adherence Scale Score From Baseline to 24 Weeks|The Morisky Medication Adherence scale (MMAS-8 scale) is a recognized indicator of medication adherence, consisting of 8 questions with a sum score ranging between 0 and 8 points. The higher score indicates higher adherence to the prescribed therapy recommendation. It has been agreed that the score of 8 could be categorized as having high adherence, score between 6 and 7 as medium adherence and scores of 5 and less as low adherence. The change is presented as the score after 24 weeks minus the score at baseline. Therefore, a positive change score reflects an improvement in the adherence.|baseline and week 24|Patients from FAS with documented MMAS-8 score at baseline and after 24 weeks.||units on a scale||Standard Deviation|Mean
683673|NCT01524900|Secondary|Change in CD4+ Cell Count From Baseline to Week 24|The change in the Cluster of differentiation 4 (CD4+) cell count from baseline after 24 weeks was calculated by subtracting the baseline value from the value after 24 weeks. Therefore, a positive change represents an increase in CD4+ cell count.|baseline and week 24|Patients from FAS with documented CD4+ at baseline and after 24 weeks.||cells/mm^3||Standard Deviation|Mean
683674|NCT01524900|Secondary|Number of Patients With Virologic Response at Week 24 (Viral Load <50 Copies/mL)|Virologic response is defined as confirmed Human Immunodeficiency Virus (HIV) viral load of < 50 copies/mL (at two consecutive measurements after baseline) up to week 24 and without subsequent rebound or change of anti-retroviral (ARV) therapy up to week 24. A rebound is defined as two consecutive measurements of viral load (VL) ≥ 50 copies/mL, at least two weeks apart, after two consecutive measurements of VL< 50 copies/mL. A change of ARV therapy is defined as a permanent discontinuation of nevirapine extended release, addition of new ARV drugs, or alteration in background therapy. A change in the background therapy due to toxicity or intolerance is not considered as treatment failure. If no follow-up viral load was available the virologic response is Missing.|24 weeks|Patients from the Full analysis set (FAS): This patient set includes all patients in the treated set who have analysable data in at least one efficacy endpoint.||participants|||Number
683675|NCT01524900|Primary|Number of Patients Reporting Non-serious Adverse Events, Serious Adverse Events, and Non-serious and Serious Adverse Events Leading to Treatment Discontinuation|The primary endpoint is to evaluate the safety of a highly active antiretroviral therapy (HAART) that includes nevirapine extended release in routine clinical practice which is to assess the number of patients reporting non-serious adverse events (nSAEs), the number of patients with serious adverse events (SAE), the number of patients with non-serious adverse events leading to treatment discontinuation, and the number of patients with serious adverse events leading to discontinuation.|up to 72 weeks|Patients from TS.||participants|||Number
683676|NCT01524887|Secondary|Number of Infusions Discontinued, Slowed, or Interrupted Due to an AE||Throughout infusions, approximately 2-5 hours|The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product.||infusions|Participants||Number
683677|NCT01524887|Secondary|Number of Infusions Causally Associated With AEs and/or SAEs||Throughout the study period: 18 Months|The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product.||infusions|Participants||Number
683678|NCT01524887|Secondary|Number of Infusions Associated With AEs and/or SAEs Occurring During or Within 7 Days of Completion of an Infusion||During or within 7 days of completion of an infusion|||infusions|Participants||Number
683679|NCT01524887|Secondary|Number of Infusions Temporally Associated With AEs and/or SAEs|A temporal association was defined as an AE and/or SAE occurring during or within 72 hours of completion of an infusion, regardless of causality.|During or within 72 hours of completion of an infusion|The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product.||infusions|Participants||Number
683680|NCT01524887|Secondary|Number of Participants Experiencing Any AEs and/or SAEs||Throughout the study period: 18 Months|The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product.||participants|||Number
683681|NCT01524887|Secondary|Number of Participants Experiencing Study Product-related Adverse Events (AEs) and/or Serious Adverse Events (SAEs)||Throughout the study period: 18 Months|The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product.||participants|||Number
683682|NCT01524887|Secondary|Change From Baseline to Month 18 in Impact of Alzheimer´s Disease on Caregiver Questionnaire (IADCQ)|The IADCQ is a 12-item validated questionnaire that has been developed to measure the emotional, physical, and social impact of care giving on AD caregivers. Higher scores on the IADCQ are associated with a higher impact. IADCQ total score range: 0 (no impact) - 48 (greatest impact). Each item can be scored either 0 (Not at all), 1 (A little), 2 (Somewhat), 3 (A lot), or 4 (Extremely). As this is a 12-item scale, the minimum possible score is 0 and the maximum possible score is 4x12 = 48.|Baseline to 9 Months (actual time frame)|Because this study was terminated early, 9-month analyses were conducted in the subset of participants that completed at least 9 months of treatment.||Scores on a scale||Standard Deviation|Mean
683683|NCT01524887|Secondary|Change From Baseline to Month 18 in Logsdon Quality of Life in Alzheimer´s Disease (QOL-AD)|The QOL AD is a validated, 13-item instrument developed specifically for individuals with dementia. The assessment rates the participant´s quality of life for physical, emotional, interpersonal, and environmental domains. The QOL-AD total score ranged 13-52, with lower scores associated with a lower quality of life.|Baseline to 9 Months (actual time frame)|Because this study was terminated early, 9-month analyses were conducted in the subset of participants that completed at least 9 months of treatment.||Scores on a scale||Standard Deviation|Mean
683684|NCT01524887|Secondary|Change From Baseline to Month 18 in Volumetric Magnetic Resonance Imaging (MRI) Parameters: Rate of Whole Brain Atrophy and Ventricular Enlargement||Baseline to 9 Months (actual time frame)|Because this study was terminated early, 9-month analyses were conducted in the subset of participants that completed at least 9 months of treatment.||mm^3||Standard Deviation|Mean
683685|NCT01524887|Secondary|Change From Baseline to Month 18 in Neuropsychiatric Inventory (NPI)|The NPI is a validated instrument used to assess behavioral psychopathology in AD; it evaluates the frequency and severity of 10 neuropsychiatric features including delusions, hallucinations, dysphoria, anxiety, agitation/aggression, euphoria, disinhibition, irritability/lability, apathy, aberrant motor activity, sleep and night-time behavior change, and appetite and eating change. The NPI total score ranged 0-144, with higher scores indicating greater impairment.|Baseline to 9 Months (actual time frame)|Because this study was terminated early, 9-month analyses were conducted in the subset of participants that completed at least 9 months of treatment.||Scores on a scale||Standard Deviation|Mean
683686|NCT01524887|Secondary|ADCS-Clinical Global Impression of Change (CGIC) at 18 Months|The ADCS-CGIC is a validated categorical measure of change in a participant’s global clinical status between baseline and follow-up visits, based on interview of the participant and the caregiver by a skilled and experienced clinician who was blinded to treatment assignment. The ADCS-CGIC score is based on a 7-point Likert scale, ranging from 1 (marked improvement) to 7 (marked worsening).|Baseline to 9 Months (actual time frame)|Because this study was terminated early, 9-month analyses were conducted in the subset of participants that completed at least 9 months of treatment.||Scores on a scale||95% Confidence Interval|Least Squares Mean
683763|NCT01523392|Primary|Inhibition of the P2Y12 Receptor as Measured by Platelet Reaction Unit (PRU) From VerifyNow™ (a Platelet Function Test Developed by Accumetrics) at 2 Hours After Loading Dose||At 2 hours after the loading dose|Pharmacodynamic (PD) Analysis Set (N=32) - included all participants for whom PD data was available with no major protocol deviations thought to significantly affect the PD of ticagrelor or clopidogrel||PRU||95% Confidence Interval|Least Squares Mean
683687|NCT01524887|Primary|Change From Baseline to Month 18 in Alzheimer´s Disease Cooperative Study (ADCS)-Activities of Daily Living (ADL) Inventory|"The ADCS-ADL scale is a validated tool to assess instrumental and basic activities of daily living based on a 23 item structured interview of the caregiver or qualified study partner.
Scores on the ADCS-ADL range from 0-78 with lower scores indicating greater impairment; hence decreases from baseline reflect potential functional deterioration."|Baseline to 9 Months (actual time frame)|Because this study was terminated early, 9-month analyses were conducted in the subset of participants that completed at least 9 months of treatment.||Scores on a scale||Standard Deviation|Mean
683688|NCT01524887|Primary|Change From Baseline to Month 18 in Cognitive Subscale of the Alzheimer´s Disease Assessment Scale (ADAS-Cog)|"The ADAS-Cog is a validated psychometric instrument that evaluates memory (word recall, word recognition), attention, reasoning (following commands), language (naming, comprehension), orientation, ideational praxis (placing letter in envelope) and constructional praxis (copying geometric designs). This test was administered by experienced raters certified by Alzheimer’s Disease Cooperative Study (ADCS) at each site.
Scores on the ADAS-Cog range from 0-70 with higher scores indicating greater impairment; hence increases from baseline reflect potential cognitive deterioration."|Baseline to 9 Months (actual time frame)|Because this study was terminated early, 9-month analyses were conducted in the subset of participants that completed at least 9 months of treatment.||Scores on a scale||Standard Deviation|Mean
683689|NCT01524796|Secondary|Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication)|Pharmacological treatments included tricyclic antidepressants (TCA), gabapentin, non-steroidal anti-inflammatory drugs (NSAIDs), weak opioids, strong opioids, serotonin-norepinephrine reuptake inhibitors (SNRIs), lidocaine or capsaicin patch (L/C) and other (parcetamol containing drugs, xylocain gel or kinin). Participants may have used more than one pharmacological pain treatments and may be presented in more than 1 category.|After Baseline, Month 1, 2, 3 visit|Analysis population included all participants on pregabalin (Lyrica) at three months follow-up. Here “n” signifies pharmacological treatments received at the specified time point.||Participants|Participants||Number
683690|NCT01524796|Secondary|Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit|Pharmacological treatments included tricyclic antidepressants (TCA), gabapentin, non-steroidal anti-inflammatory drugs (NSAIDs), weak opioids, strong opioids, serotonin-norepinephrine reuptake inhibitors (SNRIs), lidocaine or capsaicin patch (L/C) and other (parcetamol containing drugs, xylocain gel or kinin). Participants may have used more than one pharmacological pain treatments and may be presented in more than 1 category.|Before Baseline, Month 1, 2, 3 Visit|Analysis population included all participants on pregabalin (Lyrica) at three months follow-up. Here “n” signifies pharmacological treatments received at the specified time point.||Participants|Participants||Number
683691|NCT01524796|Secondary|Pregabalin Dose|"Here, n signifies Number of participants for Baseline and Month 3 telephone interview whereas n signifies number of observations for Month 1, 2 and 3 because a participant could have had multiple visits during Month 1, 2 and 3 as this was a non-interventional study with no scheduled study visits, except Baseline visit and the Month 3 telephone interview."|After Baseline Visit; Prior to Month 1, 2, 3, Month 3 Telephonic Interview; After Month 1, 2, 3, Month 3 Telephonic Interview|Analysis population included all participants on pregabalin (Lyrica) at three months follow-up. For Baseline and Month 3 telephonic interview, “n” signifies those participants who were evaluable for this outcome. For Month 1 to Month 3, “n” signifies number of observations.||Milligram (mg) per day||Standard Deviation|Mean
683692|NCT01524796|Secondary|Work Productivity and Activity Impairment (WPAI) Questionnaire|"WPAI questionnaire assess work productivity and impairment. It is a patient-rated, six-item questionnaire regarding current employment, hours missed and actually worked, and degree to which a specified health problem affected work productivity and regular activities over the past seven days. Subscale scores include Percent work time missed due to pain (PWP), Percent overall work impairment (PWI), Percent work productivity impairment due to pain (PWPI), Percent overall activity impairment (PAI). Each subscale score is expressed as an impairment percentage (0-100) where higher numbers indicate greater impairment and less productivity. Here, n signifies Number of participants for Baseline whereas n signifies number of observations for Month 1, 2 and 3 because a participant could have had multiple visits during Month 1, 2 and 3 as this was a non-interventional study with no scheduled study visits, except Baseline visit and the Month 3 telephone interview."|Baseline, Month 1, 2, 3|Safety analysis set included those participants who received at least 1 dose of the drug under study. Here number of participants analyzed “N” signifies those participants who were evaluable for this measure. For Baseline, “n”=those participants who were evaluable for this outcome. For Month 1 to Month 3, “n”=number of observations.||Units on a scale||Standard Deviation|Mean
683693|NCT01524796|Secondary|Health-related Quality of Life Scale Score|"Health-related Quality of Life was measured using Euro Quality of Life-5 dimensions (EQ-5D) scale. EQ-5D is a standardized generic instrument to assess health-related quality of life on 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). The scale rates current participant’s health state on a scale from 0 (worst imaginable health state) to 1 (best imaginable health state); higher scores indicate a better health state. Here, n signifies Number of participants for Baseline whereas n signifies number of observations for Month 1, 2 and 3 because a participant could have had multiple visits during Month 1, 2 and 3 as this was a non-interventional study with no scheduled study visits, except Baseline visit and the Month 3 telephone interview."|Baseline, Month 1, 2, 3|Safety analysis set included those participants who received at least 1 dose of the drug under study. Here number of participants analyzed “N” signifies those participants who were evaluable for this measure. For Baseline, “n”=those participants who were evaluable for this outcome. For Month 1 to Month 3, “n”=number of observations.||Units on a scale||Standard Deviation|Mean
683694|NCT01524796|Secondary|Number of Participants With Categorical Scores On Patient Global Impression of Change (PGI-C)|PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Number of participants in each category are reported.|Month 3 telephonic interview|Analysis population included all participants on pregabalin (Lyrica) at three months follow-up.||Participants|||Number
683695|NCT01524796|Secondary|Sleep Interference Scale Score|"Sleep Interference was assessed on an 11-point Sleep Numeric Rating Scale (NRS-11) where a score of 0 indicated pain did not interfere with sleep and a score of 10 indicated “pain completely interfered with sleep. Here, n signifies Number of participants for Baseline and Month 3 telephone interview whereas n signifies number of observations for Month 1, 2 and 3 because a participant could have had multiple visits during Month 1, 2 and 3 as this was a non-interventional study with no scheduled study visits, except Baseline visit and the Month 3 telephone interview."|Baseline, Month 1, 2, 3, Month 3 telephonic interview|Analysis population included all participants on pregabalin (Lyrica) at three months follow-up. For Baseline and Month 3 telephonic interview, “n” signifies those participants who were evaluable for this outcome. For Month 1 to Month 3, “n” signifies number of observations.||Units on a scale||Standard Deviation|Mean
683696|NCT01524796|Primary|Change From Baseline In Least Pain Level At Month 3 Telephonic Interview|"Pain was assessed on an 11-point NRS where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Baseline, Month 3 Telephonic Interview|Analysis population included all participants on pregabalin (Lyrica) at three months follow-up.||Units on a scale||Standard Deviation|Mean
683697|NCT01524796|Primary|Change From Baseline In Worst Pain Level At Month 3 Telephonic Interview|"Pain was assessed on an 11-point NRS where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Baseline, Month 3 Telephonic Interview|Analysis population included all participants on pregabalin (Lyrica) at three months follow-up.||Units on a scale||Standard Deviation|Mean
683698|NCT01524796|Primary|Change From Baseline In Average Pain Level At Month 3 Telephonic Interview|"Pain was assessed on an 11-point numeric rating scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Baseline, Month 3 Telephonic Interview|Analysis population included all participants on pregabalin (Lyrica) at three months follow-up.||Units on a scale||Standard Deviation|Mean
683699|NCT01524783|Secondary|Pharmacokinetics (PK)|A single blood sample to determine the exposure of everolimus at the steady-state pre-dose concentration (Cmin).|Visit 3 (Cycle 2, Study Day 29)||||||
683700|NCT01524783|Secondary|Time to Definitive Deterioration in WHO Performance Status Change During the Study|The estimated average duration is at least 5-8.5 months until disease progression. WHO Performance Status is a scale rated from 0 (normal) to 5 (dead) by a healthcare professional to assess the overall status of a patient. Deterioration is defined as an increase of at least one category compared to baseline.|Every visit up from randomization to 5 years||||||
683701|NCT01524783|Secondary|Change in Chromogranin A (CgA) and Neuron Specific Enolase (NSE) Levels During the Study|The estimated average treatment duration is at least 5-8.5 months until disease progression. CgA and NSE are potential biomarkers for tumor response. Change from baseline will be noted and correlated with tumor response.|Every visit from baseline up to 5 years||||||
683702|NCT01524783|Secondary|Disease Control Rate (DCR)|The estimated average treatment duration is at least 5-8.5 months until disease progression. DCR will be assessed per modified RECIST 1.0. DCR is the proportion of patients with best overall response of CR, PR or stable disease (SD).|5 years||||||
683703|NCT01524783|Secondary|Objective Response Rate (ORR)|ORR will be assessed per modified RECIST 1.0. ORR is the proportion of patients with a best overall response of complete response (CR) or partial response (PR).|Every Visit from randomization up to 5 years||||||
683704|NCT01524783|Secondary|FACT-G Total Score Over the Duration of the Study|FACT-G is a self-assessed health-related quality of life questionnaire. The questionnaire is comprised of 27 questions, scored 0 to 4, examining physical, social/family, emotional, and functional well-being. Deterioration is defined as a decrease by at least 7 points compared to baseline.|Every Visit from randomization up to 5 years||||||
683705|NCT01524783|Secondary|Overall Safety Evaluation of Everolimus Versus Placebo|The assessment of safety will be based mainly on the frequency and type of treatment emergent adverse events and on the number of laboratory values that fall outside of pre-determined ranges. Other safety data (e.g. vital signs) will be considered as appropriate. Safety events will be graded using the CTCAE V4.03 (Common Terminology Criteria for Adverse Events).|Every visit from randomization up to 5 years||||||
683706|NCT01524783|Secondary|Overall Survival (OS) Using Kaplan-Meier|OS is defined as the time from the date of randomization to date of death due to any cause.|Every visit from randomization up to 18 months|The full analysis set (FAS) consists of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment arm and stratification factors they were assigned to at randomization.||Percentage of participants||95% Confidence Interval|Number
683707|NCT01524783|Primary|Progression Free Survival (PFS) Based on Central Radiology Assessment Per Kaplan-Meier|PFS is defined as the time from randomization to the date of the first documented tumor progression as per modified RECIST 1.0 or death from any cause, whichever comes first. Progression is assessed by cat scan (CT) and/or magnetic resonance imaging (MRI).|From date of randomization to progression or death up to 18 months|The full analysis set (FAS) consists of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment arm and stratification factors they were assigned to at randomization.||Percentage of participants||95% Confidence Interval|Number
683708|NCT01524770|Secondary|Pharmacokinetics: Time to Maximum Concentration (Tmax) for Dulaglutide||Predose to 336 hours postdose|Participants who received at least 1 dose of dulaglutide with evaluable concentration-time data.||hours||Full Range|Median
683709|NCT01524770|Primary|Pharmacokinetics: Maximum Concentration (Cmax) for Dulaglutide||Predose to 336 hours postdose|Participants who received at least 1 dose of dulaglutide and have evaluable dulaglutide concentration data.||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
683710|NCT01524770|Primary|Pharmacokinetics: Area Under the Concentration Curve (AUC[0-336]) for Dulaglutide||Predose to 336 hours postdose|Participants who received at least 1 dose of dulaglutide and have evaluable dulaglutide concentration data.||nanograms times hours per milliliters||Geometric Coefficient of Variation|Geometric Mean
683711|NCT01524627|Primary|Cigarettes Per Day|Cigarettes per day at Baseline versus 8 weeks of treatment, placebo-controlled|last week of treatment (1-8 weeks)|Population was the number of randomized subjects who participated in any treatment length. One subject per group was not included in this analysis as one withdrew a few days after their first scan and the other was lost to follow up after their first scan.||cigarettes per day||Standard Error|Mean
683712|NCT01524302|Primary|Serum Cidal Activity as Tested Against Staphylococcus Aureus Isolates and Reported as Ex-vivo Effect (Log Inhibition of Growth)|"Serum cidal activity of serum collected at 2 hour (levofloxacin) and 12 hour (ceftaroline) time points from the patients was tested against methyicillin-sensitive staphylococcus aureus isolates and the ex-vivo effect reported as log inhibition (logrithmic measurement of the decrease in microbiological growth).
These staphylococcus aureus isolates had a range of minimum inhibitory concentrations (MIC) to Levofloxacin, 0.5, 1.0, 2.0, and 4.0 and the MIC's to Ceftaroline were 0.125, 0.19, 0.094, 0.094, respectively."|2 hour (levofloxacin) and 12 hour (ceftaroline) after receiving the drug|||Log inhibition|||Number
683713|NCT01524302|Secondary|Mean (SD) Doripenem Pharmacokinetic (PK) Area Under Serum Curve (mg*h/L) Parameter in Community-Acquired Bacterial Pneumonia Patients.|To determine the serum pharmacokinetic Area Under Serum Curve parameter of ceftaroline and levofloxacin in community-acquired bacterial pneumonia patients. We obtained blood at 2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion and measured these levels (mg/L)by LC/MS/MS assay.|2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion|||mg*hr/L||Standard Deviation|Mean
683714|NCT01524302|Secondary|Mean (SD) Ceftaroline and Levofloxacin Pharmacokinetic (PK) Half Life Parameter in Community-Acquired Bacterial Pneumonia Patients|To determine the serum pharmacokinetic half life parameter of ceftaroline and levofloxacin in community-acquired bacterial pneumonia patients. We obtained blood at 2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion and measured these levels (mg/L)by LC/MS/MS assay.|2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion|||hours||Standard Deviation|Mean
683715|NCT01524302|Secondary|Mean (SD) Doripenem Pharmacokinetic (PK) Clearance of Drug Parameter in Community-Acquired Bacterial Pneumonia Patients|To determine the serum pharmacokinetic clearance of drug parameter of ceftaroline and levofloxacin in community-acquired bacterial pneumonia patients. We obtained blood at 2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion and measured these levels (mg/L)by LC/MS/MS assay.|2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion|||liters per hour||Standard Deviation|Mean
683716|NCT01524302|Secondary|Mean (SD) Ceftaroline and Levofloxacin Pharmacokinetic Volume of Distribution Parameter in Community-Acquired Bacterial Pneumonia Patients|To determine the serum pharmacokinetic volume of distribution of ceftaroline and levofloxacin in community-acquired bacterial pneumonia patients. We obtained blood at 2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion and measured these levels (mg/L)by LC/MS/MS assay.|2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion|||Liters||Standard Deviation|Mean
683717|NCT01524198|Secondary|Change in Asthma Score From Baseline as Compared to the Score at Disposition|A negative change of asthma score from baseline measurement to measurement at disposition, which could be at 2, 3, or 4 hours time points would indicate a decrese in asthma severity. The asthma score ranged between 5 and 15 points as in the protocol, where 5 is the mildest and 15 is the most severe.|2, 3, or 4 hours from baseline|||units on asthma score||Standard Deviation|Mean
683718|NCT01524198|Primary|Patients Hospitalization Rate|The number of patients hospitalized over the study period (17 months).|17 months|||participants|||Number
683719|NCT01523964|Primary|Number of Subjects With an Adverse Event.|Adverse events will be assessed during the time the subject is enrolled in the trial.|1 day|||participants|||Number
683720|NCT01523899|Secondary|Clinical Outcome at One or Three Months|Recurrence of abscess within a three month time period|3 months|||Participants|||Count of Participants
683721|NCT01523899|Secondary|Participant Clinical Improvement Post-treatment at One Week|clinical improvement (decreasing erythema, pain, swelling, drainage, and presence or absence of fever) will be documented at 2-7 day phone follow up and 1 and 3 months|2 to 7 days|||Participants|||Count of Participants
683722|NCT01523899|Primary|Number of Participants With Antibiotic Usage at the Time of the ED Visit|Number of Participants with Antibiotic Usage at the time of the ED visit (narrow spectrum, broad spectrum, or none) will be recorded at the time of the ED visit|Baseline|||Participants|||Count of Participants
683723|NCT01523886|Secondary|Anti-emetics|Use of anti-emetics during the first 24 hours after surgery|During the first 24 hours after surgery||||||
683724|NCT01523886|Secondary|Nausea and Vomiting|The incidence of nausea and vomiting during the first 24 hours after surgery|The first 24 hours after surgery||||||
683725|NCT01523886|Secondary|Consumption of Analgesics|Consumption of analgesics during the first 24 hours after surgery|The first 24 hours after surgery||||||
683726|NCT01523886|Secondary|Duration of Anesthesia|Duration of anesthesia|From induction of anesthesia to patient ready to leave the operating theatre||||||
683727|NCT01523886|Secondary|Duration of Surgery|Duration of surgery|From surgical incision to last suture has been placed.||||||
683728|NCT01523886|Secondary|Surgical Procedures at Low Pneumoperitoneum|Number of procedures which can be done with pneumoperitoneum 8 mmHg|From surgical incision to last suture has been placed, an expected average of 30 minutes.||||||
683729|NCT01523886|Secondary|Normal Functional Level|Numer of days before re-establing normal functional level|from the day of surgery to re-establishing normal functional level - an expected average of 7 days.||||||
683730|NCT01523886|Secondary|Pain|Pain (shoulder, incision, deeop abdominal and general) at arrival to the postanesthesia care department, 2 hours and 1 day after surgery.|At arrival to the postanesthesia care department, 2 hours and 1 day after surgery||||||
683731|NCT01523886|Secondary|Pain|Pain (shoulder, incision, deep abdominal and general) as the area under the curve from preoperatively to 7 days after surgery.|Preoperatively to 7 days after surgery||||||
683732|NCT01523886|Secondary|Surgical Space Conditions|The surgical space conditions during dissection of the gallbladder (4-stage scale and VAS 0-100).|During dissection of the gallbladder||||||
683733|NCT01523886|Secondary|Surgical Space Conditions|The average surgical space conditions (VAS 0-100 and 4-stage scale) during the procedure.|From surgical incision to last suture has been placed, an expected average of 30 minutes.||||||
683734|NCT01523886|Secondary|Surgical Space Conditions|The surgical space conditions (VAS 0-100) assessed at the time during surgery, when they were poorest|From surgical incision to last suture has been placed, an expected average of 30 minutes.||||||
683735|NCT01523886|Primary|The Percentage of Patients With Optimal Surgical Space Conditions ( 1 at a 4-step Scale) Assessed at the Time During Surgery, When View Was Less|The surgical space conditions (4-stage scale) assessed at the time during surgery, when view was less. The laparoscopies were performed by experienced surgeons, whom were asked to evaluate surgical space conditions with a 4-point scale : Grade 1 (“optimal”) = “optimal” surgical space conditions; Grade 2 (good) = non-optimal conditions, but an intervention was not considered; Grade 3 (acceptable) = an intervention was considered in order to improve surgical space; Grade 4 (poor) = inadequate conditions and an intervention was necessary in order to ensure acceptable surgical space.|From surgical incision to last suture has been placed, an expected average of 30 minutes|||percentage of patients|||Number
683736|NCT01523873|Secondary|Diagnostic Quality|"Diagnostic quality was assessed by the radiologist by answering the question could you come to a diagnostic ? (answer : yes or no)."|Up to 1 hour (as the duration of usual follow-up post Dotarem administration was from less than 30 min to 1 hour)|Data were missing for 308 patients.||participants|||Number
683737|NCT01523873|Secondary|Image Quality|Image quality was assessed by the radiologist using a scale with five classes: very poor, poor, fair, good and very good.|Up to 1 hour (as the duration of usual follow-up post Dotarem administration was from less than 30 min to 1 hour)|Data were missing for 164 patients.||participants|||Number
683738|NCT01523873|Secondary|Nephrogenic Systemic Fibrosis Incidence|For any patient identified with moderate to severe impaired renal function at the time of inclusion, a specific safety follow-up was performed in order to detect any suspicion of Nephrogenic Systemic Fibrosis.|Follow-up of at least 3 months after magnetic resonance examination|Patients of the Safety Population with moderate to severe impaired renal function.||participants|||Number
683739|NCT01523873|Primary|Frequency of Adverse Events|Adverse Events were notified and described.|During the time of usual follow-up post Dotarem administration (from less than 30 min to 1 hour after magnetic resonance examination).|||Adverse Events|||Number
683740|NCT01523756|Primary|Leakage Under the Base Plate Using a 24-point Scale|Leakage under the baseplate was measured with a 24 point scale where 0 points represents no leakage (best possible out come) and 24 points represents leakage on the whole plate (worst possible outcome)|Each product will be tested 2 weeks|||units on a scale|Participants|Standard Deviation|Mean
683741|NCT01523743|Primary|Quality of Life (0-100 Point)|Difference in intermittent self-catheterisation quality of life measure, comparing compact versus standard urinary intermittent catheters The range of the scale is 0-100 where a high score indicating a high level of Quality of Life.|6 weeks|The primary analysis was based on the ITT population which included 118 subjects. 7 subjects were excluded from the ITT population. They were excluded because they discontniued the investigation and only baseline data was collected from them. Furthermore, not all subjects in the ITT population answered the QoL questionaire for both products.||units on a scale||Standard Deviation|Mean
683742|NCT01523613|Secondary|Restored Tooth Performance|"Cut-off: Restored tooth failure (tooth in need of repair or management) as determined by Tooth integrity (enamel/tooth fracture), Sensitivity and Vitality assessment within both arms.
Clinically successful is defined as: No need for repair or management due to sensitivity or loss of tooth integrity or vitality."|2 years|"21 Subjects with 2 paired restorations (21 R, 21 F).
48 Subjects with a single restoration (23 R, 25 F)."||Restored tooth|Restored tooth||Count of Units
683743|NCT01523613|Secondary|Caries Incidence Associated With Restoration|"- Caries free restorations is defined as: free of caries associated with restoration."|2 years|"21 Subjects with 2 paired restorations (21 R, 21 F).
48 Subjects with a single restoration (23 R, 25 F).
In Total: 69 subjects, 90 restorations."||Restoration|Restoration||Count of Units
683744|NCT01523613|Primary|Survival Rate|"Cut-off: Restoration failure as determined by (need for) replacement due to fracture and retention losses within both arms.
Clinically successful is defined as: no need for replacement due to fracture or retention losses."|2 years|"21 Subjects with 2 paired restorations (21 R, 21 F).
48 Subjects with a single restoration (23 R, 25 F).
Recall total: 69 subjects, 90 restorations.
No retention losses: all restorations (both R and F) in-situ and bonded; no exposed dentin."||Restorations|Restorations||Count of Units
683745|NCT01523587|Secondary|Change in Score Over Time in Coughing,Dyspnoea and Pain|"Health related quality of life (HRQoL) was measured with the following multi dimensional questionnaires: the EORTC QLQ-C30. The questionnaires were assessed at the first visit of each treatment course. For each of the summary scales and items measuring cough, dyspnoea and pain, the two treatment arms were compared in terms of change in score over time, adjusted for baseline score and race.
Questionnaires have items relating to Cough, Dyspnoea and Pain. Overall Scores are transformed to a standardised scale of 0 to 100 with the larger value indicating a worse outcome. A change of (+/-) 10 points is considered to be relevant.
The change in cough, dyspnea and pain will be assessed using a mixed effects growth curve model with the average profile over time for each endpoint described by a piecewise linear model (presented as post baseline in data table)."|First treatment administration up to 28 days after last intake of study medication|Randomised set i.e. all patients who were randomised regardless of whether they received investigational treatment.||units on a scale||Standard Error|Mean
683746|NCT01523587|Secondary|Summary of Time to Deterioration in Coughing, Dyspnoea and Pain.|Health-related quality of life (HRQoL) was measured with the following multi-dimensional questionnaires: the EORTC QLQ-C30. The questionnaires were assessed at the first visit of each treatment course. For each of the summary scales and items measuring cough, dyspnoea and pain, the two treatment arms were compared in terms of: Time to deterioration.|First treatment administration up to 28 days after the last intake of study medication.|Randomised set i.e. all patients who were randomised, regardless of whether they received investigational treatment.||months||95% Confidence Interval|Median
683747|NCT01523587|Secondary|Status Change in Cough, Dyspnoea and Pain Related Items Over Time in Health Related Quality of Life Questionnaire|"Health-related quality of life (HRQoL) was measured with the following multi-dimensional questionnaires: the EORTC QLQ-C30 questionnaire and its lung cancer specific supplementary module EORTC QLQ-LC13 and the EQ-5D health status self-assessment questionnaire. The questionnaires were assessed at the first visit of each treatment course, at EOT and follow up prior to clinical assessment. The results displayed show improvement in the relevant criteria.
For each of the summary scales and items measuring cough, dyspnoea and pain, the two treatment arms were compared in terms of: The proportion of patients that were improved: Change in cough; dyspnoea and pain scores over time."|First treatment administration up to 28 days after the last intake of study medication.|Randomised Set i.e. all patients who were randomised, regardless of whether they received investigational treatment.||participants|||Number
683748|NCT01523587|Secondary|Tumour Shrinkage|"Maximum percentage decrease from baseline in the sum of target lesion diameters following independent review.
The change in the size (i.e. the sum of diameters (SOD)) of target lesions from baseline was derived. Tumour shrinkage for each patient was measured (based on Independent Radiologic Review (IRR)) as the minimum SOD of target lesions after randomisation.
A negative percentage indicates decrease from baseline; positive numbers indicate an increase of tumour size. The mean maximum decrease from baseline of +5 and +9.4 reflect an average increase in tumour size."|First treatment administration until cut off date of 7th October 2013 (up to 78 weeks).|Patients from the randomised set with tumour assessments are considered for the analysis of this endpoint.||percentage of decrease||Standard Deviation|Mean
683749|NCT01523587|Secondary|Disease Control According to RECIST 1.1|Disease control (defined as CR, PR or Stable Disease (SD)) according to RECIST 1.1.|First treatment administration until cut off date of 7th October 2013 (up to 78 weeks).|Randomised Set i.e. all patients who were randomised, regardless of whether they received investigational treatment.||participants|||Number
683750|NCT01523587|Secondary|Objective Response According to RECIST 1.1|Objective response as defined by RECIST 1.1 as either complete response (CR) or partial response (PR).|First treatment administration until cut off date of 7th October 2013 (up to 78 weeks).|Randomised Set i.e. all patients who were randomised, regardless of whether they received investigational treatment.||participants|||Number
683751|NCT01523587|Secondary|Overall Survival|"The primary analysis of Overall Survival (OS) will be conducted after 632 deaths have occured.
Overall Survival is defined as the time from randomisation to death."|From randomisation until 632 deaths||08/2017||||
683752|NCT01523587|Primary|Progression-free Survival, Based on Central Independent Review as Determined by RECIST 1.1|The primary endpoint of this study was Progression Free Survival (PFS), as determined by central independent review according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. PFS was defined as the time from randomisation to disease progression (or death if the patient died before progression).|First treatment administration up until cut off date of 7th October 2013 (up to 78 weeks).|Randomised Set i.e. all patients who were randomised, regardless of whether they received investigational treatment.||Months||95% Confidence Interval|Median
683753|NCT01523457|Secondary|Correlate Time to Progression, Objective Response, and Overall Survival With Early Changes in Glucose Metabolism Using FDG-positron Emission Tomography (PET) Scanning|The time to progression, objective response rate, and overall survival will be correlated with early changes in glucose metabolism using FDG-positron emission tomography (PET) scanning in patients with metastatic disease and locally advanced disease.|24 weeks|This outcome was included in the 2012 protocol registration and actually describes a series of analyses that were not fully conducted, and will not be. The outcome measures described in the outcome description are presented as separated outcome measures elsewhere in this results record.|||||
683754|NCT01523457|Secondary|Rate of Resection in Patients With Locally Advanced Disease|The rate of surgical resection in the cohort of patients with locally advanced disease will be determined.|24 weeks|Only LAPC patients were considered in the analysis. 13 patients in the LAPC group had surgical resection. The definition of locally unresectable and borderline were clarified in the protocol.||participants|||Number
683755|NCT01523457|Secondary|Toxicity|Toxicities will be assessed according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0. Rates of grade 3 and 4 toxicities will be compared to historical controls. MPC and LAPC are combined because they were given the exact same medication. The study aimed to compare this dosage with historical dosage, so this comparison is the most appropriate.|24 weeks|One of the total 75 patients did not receive treatment and was excluded from toxicity analysis. Treatment-related grade 3 and 4 adverse events observed in our study and in the historical control group treated with standard FOLFIRINOX.||participants|||Number
683756|NCT01523457|Secondary|Overall Survival|Overall survival will be determined in patients with metastatic disease and in patients with locally advanced disease.|24 weeks|Two of 31 patients with LAPC were excluded from efficacy analysis because they did not complete four cycles to reach the first efficacy assessment (one due to cholecystitis with abscess and one due to cerebrovascular accident).||percentage of participants|||Number
683757|NCT01523457|Secondary|Objective Response Rate|Response will be assessed by Response Evaluation Criteria in Solid Tumors (RECIST 1.1 by independent radiology review) at 8 week intervals in patients with metastatic disease and in patients with locally advanced disease.|24 weeks|Two of 31 patients with LAPC were excluded from efficacy analysis because they did not complete four cycles to reach the first efficacy assessment (one due to cholecystitis with abscess and one due to cerebrovascular accident).||percentage of participants|||Number
683758|NCT01523457|Primary|Progression Free Survival|The primary objective of this study is to determine the progression free survival in patients with metastatic pancreatic cancer and in patients with locally advanced unresectable non-metastatic pancreatic cancer treated with a dose-attenuated modification of FOLFIRINOX. Tumour response was determined according to RECIST 1.1 by independent radiology review.|24 weeks|Two of 31 patients with LAPC were excluded from efficacy analysis because they did not complete four cycles to reach the first efficacy assessment (one due to cholecystitis with abscess and one due to cerebrovascular accident).||percentage of participants|||Number
683759|NCT01523392|Secondary|AR-C124910XX (an Active Metabolite of Ticagrelor) Plasma Concentrations After the Loading and Maintenance Doses|The standard deviation (SD) is the geometric SD|Predose, 0.5 hour, 2 hours, 8 hours from loading dose and 0, 2 hours, 8 hours and 12 hours from last dose|Pharmacokinetic (PK) Analysis Set - included all patients for whom at least one valid PK reading was available||ng/mL||Standard Deviation|Geometric Mean
683760|NCT01523392|Secondary|Ticagrelor Plasma Concentrations After the Loading and Maintenance Doses|The standard deviation (SD) is the geometric SD|Predose, 0.5 hour, 2 hours, 8 hours from loading dose; 0, 2 hours, 8 hours and 12 hours from last dose|Pharmacokinetic (PK) Analysis Set - included all patients for whom at least one valid PK reading was available||ng/mL||Standard Deviation|Geometric Mean
683761|NCT01523392|Secondary|Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 2 Hours and 8 Hours on Day 7 After Multiple Doses and at End of Dosing Interval on Day 8||At 2 hours and 8 hours on Day 7 after multiple doses and at end of dosing interval on Day 8|PD Analysis Set||PRU||95% Confidence Interval|Least Squares Mean
683762|NCT01523392|Secondary|Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 0.5 Hour and 8 Hours After Loading Dose||At 0.5 hour and 8 hours after the loading dose|PD Analysis Set||PRU||95% Confidence Interval|Least Squares Mean
683765|NCT01523366|Secondary|Ticagrelor Plasma Concentrations After the Loading and Maintenance Doses|The standard deviation (SD) is a statistic using the log-transformed data and is not the geometric SD.|Predose, 0.5, 2, 8 hours from loading dose; 0, 2, 8 and 12 hours from last dose|Pharmacokinetic (PK) Analysis Set, defined as all participants for whom at least one valid PK reading was available||ng/mL||Standard Deviation|Geometric Mean
683766|NCT01523366|Secondary|Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 2 and 8 Hours on Day 7 After Multiple Doses and at End of Dosing Interval on Day 8|The end of dosing interval was approximately 12 hours after the last evening dose of ticagrelor and approximately 24 hours after the last morning dose of clopidogrel. Participants with low (<150) baseline PRU values (indicating an incomplete washout from anti-platelet therapy) were excluded during the period corresponding to the low baseline value|At 2 hours and 8 hours on Day 7 after multiple doses, and at the end of dosing interval on Day 8|PD Analysis Set||PRU||95% Confidence Interval|Least Squares Mean
683767|NCT01523366|Secondary|Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 0.5 and 8 Hours After Loading Dose|Participants with low (<150) baseline PRU values (indicating an incomplete washout from anti-platelet therapy) were excluded during the period corresponding to the low baseline value|At 0.5 and 8 hours after the loading dose|PD Analysis Set||PRU||95% Confidence Interval|Least Squares Mean
683768|NCT01523366|Primary|Inhibition of the P2Y12 Receptor as Measured by P2Y12 Reactions Units (PRU) From VerifyNow™ (a Platelet Function Test Developed by Accumetrics) at 2 Hours After Loading Dose|Participants with low (<150) baseline PRU values (indicating an incomplete washout from anti-platelet therapy) were excluded during the period corresponding to the low baseline value|At 2 hours after the loading dose|Pharmacodynamic (PD) Analysis Set||PRU||95% Confidence Interval|Least Squares Mean
683769|NCT01523301|Secondary|Change From Baseline to the End of Maintenance Period in the Score of Snaith-Hamilton Pleasure Scale (SHAPS)|The SHAPS is a self-report instrument developed for the assessment of hedonic capacity. The sum of the 14 items scores ranges from 0 to 14. A higher score represents more anhedonic symptoms.|From Baseline (Week 0) to end of Maintenance Period (up to Week 15)|Efficacy Evaluable Set (EES) consisted of all subjects from the Full Analysis Set (FAS) with a baseline total HAM-D score of 12 or larger.||units on a scale||95% Confidence Interval|Least Squares Mean
683770|NCT01523301|Secondary|Change From Baseline to the End of Maintenance Period in the Score of Apathy Scale (AS)|The AS is an abbreviated version of the Apathy Scale (AS). The AS consists of 14 items phrased as questions that are to be answered on a four-point Likert scale. It was developed specifically for patients with Parkinson Disease (PD). For questions 1-8, the scoring system is the following: not at all = 3 points; slightly = 2 points; some =1 point, a lot = 0 point. For questions 9-14: the scoring system is the following: not at all = 0 points; slightly = 1 point; some = 2 points; a lot = 3 points. Adding all scores provides the final score with a range from 0 to 42.|From Baseline (Week 0) to end of Maintenance Period (up to Week 15)|Efficacy Evaluable Set (EES) consisted of all subjects from the Full Analysis Set (FAS) with a baseline total HAM-D score of 12 or larger.||units on a scale||95% Confidence Interval|Least Squares Mean
683771|NCT01523301|Secondary|Change From Baseline to the End of Maintenance Period in the Combined Score of Unified Parkinson’s Disease Rating Scale (UPDRS) Part II (ADL) Plus Part III (Motor Subscale)|The combined score of UPDRS part II and UPDRS part III is the sum of the individual scores and threfore ranges from 0 (normal) to 160 (severe).|From Baseline (Week 0) to end of Maintenance Period (up to Week 15)|Efficacy Evaluable Set (EES) consisted of all subjects from the Full Analysis Set (FAS) with a baseline total HAM-D score of 12 or larger.||units on a scale||95% Confidence Interval|Least Squares Mean
683772|NCT01523301|Secondary|Change From Baseline to the End of Maintenance Period in the Score of Unified Parkinson’s Disease Rating Scale (UPDRS) Part III (Motor Subscale)|Improvement of motor symptoms is measured by the change from Baseline in UPDRS Part III motor score. The UPDRS Part III is an accepted and validated scale for the assessment of motor function in Parkinson’s disease. Each of the elements in the UPDRS Part III is measured on a scale of 0 to 4, where 0 is normal and 4 represents severe abnormalities. The total score of UPDRS part III ranges from 0 (normal) to 108 (severe abnormalities).|From Baseline (Week 0) to end of Maintenance Period (up to Week 15)|Efficacy Evaluable Set (EES) consisted of all subjects from the Full Analysis Set (FAS) with a baseline total HAM-D score of 12 or larger.||units on a scale||95% Confidence Interval|Least Squares Mean
683773|NCT01523301|Secondary|Change From Baseline to the End of Maintenance Period in the Score of Unified Parkinson’s Disease Rating Scale (UPDRS) Part II (Activities of Daily Living-ADL Subscale)|The UPDRS Part II is a tool to measure Activities in Daily Living – it includes speech, salivation, swallowing, handwriting, cutting food and handling utensils, dressing, hygiene, turning in bed and adjusting clothes, falling (unrelated to freezing), freezing when walking, walking, tremor, and sensory complaints related to Parkinsonism. Each of the 13 questions is measured on a scale from 0 (normal) to 4 (severe). The total score of UPDRS part II ranges from 0 (normal) to 52 (severe).|From Baseline (Week 0) to end of Maintenance Period (up to Week 15)|Efficacy Evaluable Set (EES) consisted of all subjects from the Full Analysis Set (FAS) with a baseline total HAM-D score of 12 or larger.||units on a scale||95% Confidence Interval|Least Squares Mean
683774|NCT01523301|Secondary|Change From Baseline to the End of Maintenance Period in the Score of Beck Depression Inventory (BDI-II)|The Beck Depression Inventory II (BDI-II) is a self-report instrument to measure Depression symptoms and severity. There are 21 items in the BDI-II. Scores of 0-13 are considered minimal depression; 14-19 indicates mild depression; 20-28 indicates moderate depression; and 29-63 indicates severe depression.|From Baseline (Week 0) to end of Maintenance Period (up to Week 15)|Efficacy Evaluable Set (EES) consisted of all subjects from the Full Analysis Set (FAS) with a baseline total HAM-D score of 12 or larger.||units on a scale||95% Confidence Interval|Least Squares Mean
683775|NCT01523301|Primary|Change From Baseline to the End of Maintenance Period in the Score of the Hamilton Depression Scale (HAM-D)|The HAM-D consists of 17 items. Nine of the items are scored on a 5-point scale, ranging from 0 to 4. The remaining 8 items are scored on a 3-point scale, from 0 to 2. Therefore, the total score ranges between 0 to 52, with a cutoff score of 15/16 diagnosing major depressive disorder.|From Baseline (Week 0) to end of Maintenance Period (up to Week 15)|Efficacy Evaluable Set (EES) consisted of all subjects from the Full Analysis Set (FAS) with a baseline total HAM-D score of 12 or larger.||units on a scale||95% Confidence Interval|Least Squares Mean
683776|NCT01522976|Primary|Overall Survival (Phase III)|"OS is calculated for all patients from the date of initial registration to date of death due to any cause. The follow-up for patients last known to be alive is censored at the date of last contact. Stratified Cox regression models will be used to compare OS of the combination arm selected in the Phase II portion of the trial to OS of the single-agent azacitidine arm.
This trial did not move forward to the Phase III portion, so results for this Phase III primary outcome cannot be reported. Overall survival is reported for the Phase II cohort as a secondary outcome."|Up to 5 years||||||
683777|NCT01522976|Secondary|Toxicity Rate|Adverse events that are possibly, probably or definitely related to study drug are reported.|Up to 5 years|Analysis includes only eligible patients who also received treatment.||Participants|||Number
683778|NCT01522976|Secondary|Pre-study Cytogenetic Abnormalities|Cytogenetic risk group is used to identify cytogenetic abnormalities.|Up to 5 years|Analysis includes eligible patients only.||participants|||Number
683779|NCT01522976|Secondary|Overall Survival|OS is calculated for all patients from the date of initial registration to date of death due to any cause. The follow- up for patients last known to be alive is censored at the date of last contact. OS will be estimated for each of the three arms using the Kaplan-Meier method.|Up to 5 years|Analysis includes eligible patients only.||Days||95% Confidence Interval|Median
683780|NCT01522976|Secondary|Relapse-free Survival|RFS is calculated for patients who have achieved a response. RFS will be measured from the date of response to the date of first documentation of relapse from response (as defined in the primary objective), or death due to any cause. The follow-up for patients last known to be alive and without report of relapse is censored at the date of last contact. RFS will be estimated for each of the three arms using the Kaplan-Meier method.|Up to 5 years|Analysis includes eligible patients who had a response.||Days||95% Confidence Interval|Median
683781|NCT01522976|Primary|Response Rate (Phase II)|A response is any of complete hematological remission, partial remission, or hematologic improvement.|Up to 5 years|Analysis includes eligible patients only.||percentage of patients having a response||95% Confidence Interval|Number
683782|NCT01522963|Primary|Nicotine Withdrawal Symptoms|The difference between lozenge use at the designated time-point prior to the stress task and lozenge use in withdrawal symptom response as measured by the Minnesota Nicotine Withdrawal Scale (MNWS) that occurs when smokers are exposed to a stressful task. The possible range of scores for the MNWS is between 0 and 28 with higher scores indicated greater withdrawal symptom severity.|5 to 35 minutes|||units on a scale||95% Confidence Interval|Least Squares Mean
683783|NCT01522963|Primary|Craving|The difference between lozenge use at the designated time-point prior to the stress task and lozenge use after the stress task in craving response (measured by factor 1 of the Questionnaire on Smoking Urges) that occurs when smokers are exposed to a stressful task. The possible range of scores was between 5 and 35 with higher scores indicated greater smoking urges.|Baseline, 6 months|||units on a scale||95% Confidence Interval|Least Squares Mean
683784|NCT01522937|Secondary|The Number of Patients That Experience Grade 4+ Gastrointestinal Bleeding|Grade 4 toxicities are life threatening toxicities that require urgent attention.|1 Year|||patients|||Number
683785|NCT01522937|Secondary|The Number of Patients Who Experience Grade 4+ Hepatotoxicity|Grade 4 toxicities are life threatening toxicities that require urgent attention.|1 Year|||patients|||Number
683786|NCT01522937|Secondary|The Percentage of Patients Alive at 1 Year||1 Year|||percentage of patients||95% Confidence Interval|Number
683787|NCT01522937|Secondary|The Percentage of Patients Alive Without Progression at 1 Year|Progression is defined as a greater than or equal to 20% growth of a lesion from the smallest lesion measurement|1 Year|||percentage of patients||95% Confidence Interval|Number
683788|NCT01522937|Primary|The Percentage of Patients With Local Control at 1 Year Post Treatment|For this study, local control is defined as the lack of progressive local disease following CR (Complete Response) or PR (Partial Response), or lack of progressive local disease in patients with non-evaluable disease, who have no progressive elevation in serum tumor markers.|1 Year|||percentage of patients||95% Confidence Interval|Number
683789|NCT01522924|Primary|Change From Baseline in Tobacco Cessation Knowledge Score|The tobacco cessation knowledge variable was computed by adding the participants' total number of correct answers of the ten knowledge questions. The rating scale was: 0 = incorrect and 1 = correct. A higher value represents participants' higher level of tobacco cessation treatment knowledge (Range: 0-10). The difference in the tobacco cessation knowledge from Questionnaire 1 to Questionnaire 2 was computed by subtracting the total number of participants' correct answers at Questionnaire 1 from the total number of participants' correct answers at Questionnaire 2.|Questionnaire 1 (pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)|||units on a scale||Standard Deviation|Mean
683790|NCT01522924|Primary|Change From Baseline in Intentions Score|Participants' intentions to provide tobacco cessation treatment were computed by adding values from thirteen questions to assess dental students' intent to counsel patients to quit tobacco use. The rating scale was: 0 = never, 1 = rarely, 2 = sometimes, 3 = almost always, 4 = always (every visit). A higher value represents participants' stronger intentions to provide tobacco cessation treatment (Range: 0-52). The difference in participants' intentions to provide tobacco cessation treatment from Questionnaire 1 to Questionnaire 2 was computed by subtracting the total value of participants' intentions at Questionnaire 1 from the total value of participants' intentions at Questionnaire 2.|Questionnaire 1 (baseline/pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)|||units on a scale||Standard Deviation|Mean
683791|NCT01522924|Primary|Change From Baseline in Self-efficacy Score|Self-efficacy represents an individual's confidence in his/her ability to perform a behavior. The self-efficacy variable was computed by adding the values of ten questions to assess the participants' self-efficacy to counsel patients to quit tobacco use. The rating scale was: 0 = not at all confident, 1 = not very confident, 2 = moderately confident, 3 = very confident, and 4 = extremely confident. A higher value represents participants' higher level of confidence in providing tobacco cessation treatment (Range: 0-40). The difference in participants' self-efficacy from Questionnaire 1 to Questionnaire 2 was computed by subtracting the total value of self-efficacy at Questionnaire 1 from the total value at Questionnaire 2.|Questionaire 1 (baseline/pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)|||units on a scale||Standard Deviation|Mean
683792|NCT01522924|Primary|Change From Baseline in Perceived Skills Score|The perceived skills variable was computed by adding the values of seven questions that assessed the participants' perceived level of tobacco cessation treatment skills from poor to excellent. The rating scale was: 0 = poor, 1 = fair, 2 = good, 3 = very good, and 4 = excellent. A higher value represents a higher level of tobacco cessation treatment skills perceived by participants (Range: 0-28). The difference in the participants' perceived skills from Questionnaire 1 to Questionnaire 2 was computed by subtracting the total value of perceived skills at Questionnaire 1 from the total value of perceived skills at Questionnaire 2.|Questionnaire 1(baseline/pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)|||units on a scale||Standard Deviation|Mean
683793|NCT01522924|Primary|Change From Baseline in Subjective Norms Score|Subjective norms are beliefs that people who influence your actions approve or disapprove of the behavior. The subjective norms variable was computed by adding the values of six questions to assess the participants' level of perceived social pressures to counsel patients in quitting tobacco use. Questions wer rated on a seven-point Likert scale; higher point values indicate a perceived social norm more supportive of counseling patients in quitting tobacco use(Range: 0-36). The difference in the subjective norms score from Questionnaire 1 to Questionnaire 2 was computed by subtracting the total number of participants' subjective norms at Questionnaire 1 from the total number of participants' subjective norms at Questionnaire 2.|Questionnaire 1 ( baseline/pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)|The number of participants for analysis was determined by the completing the questionnaire after the lecture or after the counseling practice sessions using standardized patients.||units on a scale||Standard Deviation|Mean
683794|NCT01522924|Primary|Change From Baseline in Perceived Barriers Score|The perceived barriers variable was computed by adding the total number of barriers reported by participants. Participants were asked to select all factors that may limit their ability to counsel tobacco users during every visit. The rating scale for reporting barriers was: 0 = no and 1 = yes. A higher value represents a higher number of barriers to providing tobacco cessation treatment reported by participants(Range: 0-11). The difference in perceived barriers from Questionnaire 1 to Questionnaire 2 was computed by subtracting the total number of perceived barriers at Questionnaire 1 from the total number of perceived barriers at Questionnaire 2.|Questionnaire 1(baseline/pre-lecture) to Questionnaire 2(post-lecture or post-lecture and counseling /debriefing sessions)|The number of participants for analysis was determined by completing the second questionnaire after the lecture or after the counseling practice sessions using standardized patients.||units on a scale||Standard Deviation|Mean
683795|NCT01522924|Primary|Change From Baseline in Attitude Score|"The attitude variable was computed by adding the values from two questionnaire items to assess the level agreement with statements: 1.) It is important for members of the profession to discuss tobacco use with patients and 2.) A brief intervention (3 minutes) for tobacco cessation with my patients would be effective. The rating scale was: 0 = strongly disagree, 1 = moderately disagree, 2 = somewhat disagree, 3 = neither disagree or agree, 4 = somewhat agree, 5 = moderately agree, and 6 = strongly agree. A higher value represents participants' more positive attitude toward providing tobacco cessation treatment (Range:0-8). The difference in the attitude from Questionnaire 1 to Questionnaire 2 was computed by subtracting the total value of the variable at Questionnaire 1 from the total value at Questionnaire 2."|Questionnaire 1 (baseline/pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)|The control group (lecture only) completed the second questionnaire after the lecture and the intervention group (counseling practice sessions) completed the second questionnaire after the counseling practice sessions and the debriefing session.||units on a scale||Standard Deviation|Mean
683796|NCT01522703|Primary|Exhaled Nitric Oxide Concentrations|exhaled nitric oxide concentrations|at 3 days|||ppb||Inter-Quartile Range|Median
683797|NCT01522456|Post-Hoc|Fitzpatrick Skin Type Overall Tolerability Preference Survey Results|Overall Tolerability Preference Survey Results at Day 22 (Safety Population) Grouped by Fitzpatrick Skin Type (FST). Data collected from available subjects on day 22. Fitzpatrick skin type is a numerical classification scale for the color of skin from Type 1 to Type VI. Skin type 1 = always burns and never tans (light, pale skin) and skin type VI = never burns, tans very easily, and is deeply pigmented (black, very dark brown to black skin). One subject did not participate in the User Preference Survey; as a result, 1 subject was not included in the FST I - III group results below.|Day 22|||participants|||Number
683798|NCT01522456|Post-Hoc|Fitzpatrick Skin Type User Preference Survey at Day 22|User Preference Survey at Day 22 (Safety Population) Grouped by Fitzpatrick Skin Type. Fitzpatrick skin type (FST) is a numerical classification scale for the color of skin from Type 1 to Type VI. Skin type 1 = always burns and never tans (light, pale skin) and skin type VI = never burns, tans very easily, and is deeply pigmented (black, very dark brown to black skin). Two subjects did not participate in the User Preference Survey; as a result, 2 subjects were not included in the FST I - III group results below.|Day 22|||participants|||Number
683799|NCT01522456|Post-Hoc|Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Stinging/Burning)|Worst Postbaseline Tolerability Assessment Grouped by Fitzpatrick Skin Type for Stinging/Burning. Fitzpatrick skin type is a numerical classification scale for the color of skin from Type 1 to Type VI. Skin type 1 = always burns and never tans (light, pale skin) and skin type VI = never burns, tans very easily, and is deeply pigmented (black, very dark brown to black skin).|Day 1 - Day 22|Safety Population||participants|||Number
683800|NCT01522456|Post-Hoc|Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Dryness)|Worst Postbaseline Tolerability Assessment Grouped by Fitzpatrick Skin Type for Dryness. Fitzpatrick skin type is a numerical classification scale for the color of skin from Type 1 to Type VI. Skin type 1 = always burns and never tans (light, pale skin) and skin type VI = never burns, tans very easily, and is deeply pigmented (black, very dark brown to black skin).|Day 1 - Day 22|Safety Population||participants|||Number
683801|NCT01522456|Post-Hoc|Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Scaling)|Worst Postbaseline Tolerability Assessment Grouped by Fitzpatrick Skin Type for Scaling. Fitzpatrick skin type is a numerical classification scale for the color of skin from Type 1 to Type VI. Skin type 1 = always burns and never tans (light, pale skin) and skin type VI = never burns, tans very easily, and is deeply pigmented (black, very dark brown to black skin).|Day 1 - Day 22|Safety Population||participants|||Number
683802|NCT01522456|Post-Hoc|Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Erythema)|Worst Postbaseline Tolerability Assessment Grouped by Fitzpatrick Skin Type for Erythema. Fitzpatrick skin type is a numerical classification scale for the color of skin from Type 1 to Type VI. Skin type 1 = always burns and never tans (light, pale skin) and skin type VI = never burns, tans very easily, and is deeply pigmented (black, very dark brown to black skin).|Day 1 - Day 22|Safety Population||participants|||Number
683803|NCT01522456|Other Pre-specified|Overall Tolerability Preference Survey|Overall tolerability preference survey taken by the subjects. Data collected from available subjects on day 22.|Day 22|Safety population||participants|||Number
683804|NCT01522456|Secondary|Cumulative Tolerability (Combined)|Cumulative tolerability assessments for erythema, scaling, dryness, and stinging/burning. Cumulative tolerability is defined as the sum of the tolerability scores for erythema, scaling, dryness, or stinging/burning. Tolerability was assessed on a 4-point categorical scale(0=none, 1=mild, 2=moderate, 3=severe) for all subjects at each visit.|Day 1 - Day 22|Safety population||scores on a scale|||Number
683805|NCT01522456|Secondary|Cumulative Tolerability (Stinging/Burning)|Cumulative tolerability assessments for stinging/burning. Cumulative tolerability is defined as the sum of the tolerability scores stinging/burning. Tolerability was assessed on a 4-point categorical scale(0=none, 1=mild, 2=moderate, 3=severe) for all subjects at each visit.|Day 1 - Day 22|Safety population||scores on a scale|||Number
683806|NCT01522456|Secondary|Cumulative Tolerability (Dryness)|Cumulative tolerability assessments for dryness. Cumulative tolerability is defined as the sum of the tolerability scores for dryness. Tolerability was assessed on a 4-point categorical scale(0=none, 1=mild, 2=moderate, 3=severe) for all subjects at each visit.|Day 1 - Day 22|Safety population||scores on a scale|||Number
683807|NCT01522456|Secondary|Cumulative Tolerability (Scaling)|Cumulative tolerability assessments for scaling. Cumulative tolerability is defined as the sum of the tolerability scores for scaling. Tolerability was assessed on a 4-point categorical scale(0=none, 1=mild, 2=moderate, 3=severe) for all subjects at each visit.|Day 1 - Day 22|Safety population||scores on a scale|||Number
683808|NCT01522456|Secondary|Cumulative Tolerability (Erythema)|Cumulative tolerability assessments for erythema. Cumulative tolerability is defined as the sum of the tolerability scores for erythema. Tolerability was assessed on a 4-point categorical scale(0=none, 1=mild, 2=moderate, 3=severe) for all subjects at each visit.|Day 1 - Day 22|Safety population||scores on a scale|||Number
683809|NCT01522456|Secondary|Tolerability at Day 22 (Stinging/Burning)|Tolerability assessments at day 22 for stinging/burning|Day 22|Safety population||participants|||Number
683810|NCT01522456|Primary|Worst Postbaseline Tolerability (Stinging/Burning)|Worst postbaseline tolerability assessments for stinging/burning|Day 1 - Day 22|Safety population||participants|||Number
683811|NCT01522456|Secondary|Tolerability at Day 22 (Scaling)|Tolerability assessments at day 22 for scaling|Day 22|Safety population||participants|||Number
683812|NCT01522456|Primary|Worst Postbaseline Tolerability (Dryness)|Worst postbaseline tolerability assessments for dryness.|Day 1 - Day 22|Safety population||participants|||Number
683813|NCT01522456|Primary|Worst Postbaseline Tolerability (Scaling)|Worst postbaseline assessment for scaling.|Day 1 - Day 22|Safety population||participants|||Number
683814|NCT01522456|Other Pre-specified|User Preference Survey (Subjects)|"Response from subjects when asked: Which side of the face feels less irritated? Data collected from available participants on each assessment day."|Day 5, day 12, day 19, and day 22|Safety population||participants|||Number
683815|NCT01522456|Other Pre-specified|User Preference Survey (Investigator)|"Response from investigator when asked: Which side of the face appears to be less irritated? Data collected from available participants."|Day 5, day 12, day 19, and day 22|Safety population||participants|||Number
683816|NCT01522456|Secondary|Tolerability at Day 22 (Dryness)|Tolerability assessments at day 22 for dryness|Day 22|Safety population||participants|||Number
683817|NCT01522456|Secondary|Tolerability at Day 22 (Erythema)|Tolerability assessments at day 22 for erythema|Day 22|Safety population||participants|||Number
683818|NCT01522456|Primary|Worst Postbaseline Tolerability (Erythema)|Worst postbaseline tolerability assessment for erythema.|Day 1 - Day 22|Safety population||participants|||Number
683819|NCT01522339|Secondary|MRI Image Quality|The following measures will be individually evaluated and compared to similar images previously acquired on an adult scanner: Overall Study Quality, Motion, Spatial Resolution, Signal to Noise, and Contrast.|Post MRI Scan for Each Infant|Number of NICU MRI Images with Equal or Better Quality than Adult Scanner Images||Images|||Number
683820|NCT01522339|Primary|Number of Participants With Adverse Events as Measured by Vital Signs, Change in Temperature, and Physical Exam|Heart rate and oxygen saturation will be measured every 15+/- 5 minutes. The infants' temperatures will be taken immediately before the MRI and again immediately after the MRI. A physical exam will be performed both immediately before and immediately after the MRI to assess for any physical changes.|Day 1|||Adverse Events|||Number
683821|NCT01522235|Secondary|Orthostatic Hypotension Symptom Assessment Questionnaire|"To determine the change in orthostatic Hypotension symptom (measured by the orthostatic hypotension symptom assessment questionnaire) measured at baseline and 6 weeks in individuals receiving IVIG. This is a 60 point orthostatic hypotenstion symptom assessment questionnaire. The minimum score possible is 0 and maximum is 60.
Higher values represent worse outcome. We are reporting the total score."|Baseline, 6 weeks|||units||Standard Deviation|Mean
683822|NCT01522235|Secondary|EuroQol [EQ-5D] Questionnaire.|"To determine the change in quality of life (measured by the EuroQol [EQ-5D]) measured at baseline and 6 weeks in individuals receiving IVIg. We have reported the subscale (EQ-VAS). The minimum score is 0 and maximum score is 100. (0) corresponds to  the worst health you can imagine, and the highest rate (100) corresponds to the best health you can imagine."|Baseline, 6 weeks|||units||Standard Deviation|Mean
683823|NCT01522235|Secondary|Composite Autonomic Severity Score (CASS) Questionnaire.|"To determine the change in autonomic symptoms (measured by the composite autonomic severity score [CASS]) measured at baseline and 6 weeks in individuals receiving IVIg.
Is a 10-point composite autonomic scoring scale of autonomic function. This scale allots 4 points for adrenergic and 3 points each for sudomotor and cardiovagal failure. Subjects with a score of 3 or less on have a mild autonomic failure, 4-6 have moderate autonomic failure and those with scores of 7 to 10 have severe failure. The minimum score possible is 3 and maximum is 10."|Baseline, 6 weeks|||units||Standard Deviation|Mean
683824|NCT01522235|Secondary|Composite Autonomic Symptom Score [COMPASS] Questionnaire|To determine the change in autonomic symptoms (measured by the composite autonomic symptom score [COMPASS] questionnaire) measured at baseline and 6 weeks. Minimum and maximum score possible: 0-100. We have reported the Total score. Higher values represent worse outcome.|Baseline, 6 weeks|||units||Standard Deviation|Mean
683825|NCT01522235|Secondary|Change in Systolic Blood Pressure During 60° Tilt (ΔSBP)|To compare the change in systolic blood pressure during 60 degree head up tilt table test after 6 and 12 weeks of IVIG (the within-patient difference in ΔSBP at 12 and 6 weeks among treated patients).|6 weeks and 12 weeks|||mmHg||Standard Deviation|Mean
683826|NCT01522235|Primary|Change in Systolic Blood Pressure During 60° Tilt (ΔSBP)|The primary outcome, the change in systolic blood pressure during 60 degree tilt (ΔSBP), will be assessed in all study participants at baseline and at 6 weeks.|Baseline and 6 weeks|||mmHg||Standard Deviation|Mean
683827|NCT01522131|Secondary|Clinical Evidence of Regeneration of Class 2 Furcation Defects Based on Changes in Vertical Pocket Depth Measurement(in mm)|Patients with periodontitis lose bone and clinical attachment over a period of time in vertical direction also. In both control and test a UNC probe marked in mm was used to quantify this loss or gain of clinical attachment in a vertical direction from the cemento-enamel junction to the most apical extent of the bone at the furcation entrance at baseline and after 6months after the procedure. These measurements were done intrasurgery and before opening of the flaps,again both at initial visit and 6 months after the procedure was done.This measurement will be measured in mm in postive numbers and then will be compared to measurements ( in mm) at intial and baseline. Increase and decrease of vertical probing depth will be noted by a positive number.|At Baseline and 6 months|||mm||Standard Deviation|Mean
683828|NCT01522131|Primary|Change in Clinical Attachment( Gain or Loss) Measured by Horizontal Clinical Attachment Loss(in mm) From Baseline to 6 Months.|Patients with periodontitis lose bone and clinical attachment over a period of time. In both control and test a Nabers probe( curved probe) marked in mm was used to quantify this loss or gain of clinical attachment in a horizontal direction from the cemento-enamel junction to the the most apical extent of the bone at the furcation entrance at baseline and after 6months after the procedure. These measurements were done intrasurgery and before opening of the flaps,again both at initial visit and 6 months after the procedure was done. This measurement will be measured in mm in postive numbers and then will be compared to measurements ( in mm) at intial and baseline. If there is a loss in attachment it will be denoted by negative number. If theres a gain in attachment it will be denoted by a positive number after the comparison.|At Baseline and 6 months|||mm||Standard Deviation|Mean
683829|NCT01521923|Secondary|Percentage of Subjects Achieving Low Disease Activity (LDA) at Week 104 in RA0055 Period 2|"LDA is defined as achieving a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) <= 3.2.
DAS28 values range from 2.0 to 10.0 with a higher value indicating a higher disease activity."|Week 104 in RA0055 Period 2|"FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses
1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2"||percentage of subjects|||Number
683830|NCT01521923|Secondary|Interference With Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2|The Arthritis interference in the last month with household productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference).|Week 104 in RA0055 Period 2|"FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses
1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2"||units on a scale||Standard Deviation|Mean
683831|NCT01521923|Secondary|Number of Days Missed of Family/Social/Leisure Activities (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2|Number of days missed of family/social/leisure activities in the last month.|Week 104 in RA0055 Period 2|"FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses
1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2"||days||Standard Deviation|Mean
683832|NCT01521923|Secondary|Number of Days With Hired Outside Help (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2|Number of days with hired outside help days in the last month.|Week 104 in RA0055 Period 2|"FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses
1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2"||days||Standard Deviation|Mean
683833|NCT01521923|Secondary|Number of Days With Reduced Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2|Number of days with reduced household work productivity in the last month.|Week 104 in RA0055 Period 2|"FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses
1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2"||days||Standard Deviation|Mean
683834|NCT01521923|Secondary|Number of Days With no Household Work (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2|Number of days with no household work in the last month.|Week 104 in RA0055 Period 2|"FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses
1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2."||days||Standard Deviation|Mean
683896|NCT01521871|Primary|Wound Healing by Numerical Scales for Blisters Postoperative Day 4.|The evaluation is performed by the use of a previously set numerical scale for blisters (0: none - 3: abundant). Both arms/groups are evaluated day 2 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.|At postop. day 4 (4 days after kidney donation)|||units on a scale||Standard Deviation|Mean
683835|NCT01521923|Secondary|Interference With Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2|"The Arthritis interference in the last month with work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference) for employed subjects.
Only the employed subjects were analyzed."|Week 104 in RA0055 Period 2|"FAS2 with LOCF. FAS2 did not include subjects who had received PBO + MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses
1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2"||units on a scale||Standard Deviation|Mean
683836|NCT01521923|Secondary|Number of Work Days With Reduced Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2|"Number of work days with reduced productivity in the last month for employed subjects.
Only the employed subjects were analyzed."|Week 104 in RA0055 Period 2|"FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses
1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2"||days||Standard Deviation|Mean
683837|NCT01521923|Secondary|Number of Work Days Missed (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2|Number of work days missed in the last month for employed subjects.|Week 104 in RA0055 Period 2|"FAS2 with LOCF. FAS2 did not include subjects who had received PBO + MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses
1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2"||days||Standard Deviation|Mean
683838|NCT01521923|Secondary|Change From Baseline in Previous Study RA0055 Period 1 in the Bristol Rheumatoid Arthritis Fatigue- Multidimensional Questionnaire (BRAF-MDQ) Total Score to Week 104 in RA0055 Period 2|BRAF-MDQ total score ranges from 0 to 70 (with higher scores indicating worse fatigue), whereas the score for each dimension is different due to the varied number of questions (0 –22 for physical, 0- 21 for living, 0- 15 for cognition, and 0- 12 for emotion). A negative value in BRAF-MDQ change from Baseline indicates an improvement from Baseline.|From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2|"FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses
1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2"||units on a scale||Standard Deviation|Mean
683839|NCT01521923|Secondary|Time to Flare From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2|"Time to flare, defined as an increase of DAS28[ESR] >= 0.6 above Week 52 DAS28[ESR] level, having a DAS28[ESR] >= 3.2 and judged by the Investigator as due to RA and all three criteria confirmed at an additional visit two weeks thereafter, from Week 52 onwards.
Data not available as > 75% of the participants failed to meet flare criteria."|Week 104 in RA0055 Period 2|"FAS2 did not include subjects who had received PBO + MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses.
1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2"||days||Geometric Coefficient of Variation|Geometric Mean
683840|NCT01521923|Secondary|Percentage of Subjects With Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) <= 3.2 at Week 104 in RA0055 Period 2|DAS28[ESR] is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x PtGADA, where 28 joints are examined and a lower score indicates less disease activity.|Week 104 in RA0055 Period 2|"FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses
1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2"||percentage of subjects|||Number
683841|NCT01521923|Secondary|Percentage of Subjects With a Health Assessment Questionnaire- Disability Index (HAQ-DI) ≤ 0.5 at Week 104 in RA0055 Period 2|"Normative physical function is defined as HAQ-DI score <= 0.5. The domains of the HAQ-DI are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities.
The total score ranges from 0 to 3 with lower scores meaning lower disability."|Week 104 in RA0055 Period 2|"FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses
1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2"||percentage of subjects|||Number
683842|NCT01521923|Secondary|Change From Week 52 in Previous Study RA0055 Period 1 in Simplified Disease Activity Index (SDAI) to Week 104 in RA0055 Period 2|"SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm), Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in mm) and C-Reactive Protein (CRP in mg/L). 28 joints are examined where a lower score indicates less disease activity.
The SDAI score ranges from 0 to 86, with a negative value in SDAI change from Baseline indicating an improvement from Baseline."|From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2|"FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses
1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2"||units on a scale||Standard Deviation|Mean
683897|NCT01521871|Primary|Wound Healing by Numerical Scales for Blisters Postoperative Day 2.|The evaluation is performed by the use of a previously set numerical scale for blisters (0: none - 3: abundant). Both arms/groups are evaluated day 2 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.|At postop. day 2 (2 days after kidney donation)|||units on a scale||Standard Deviation|Mean
683843|NCT01521923|Secondary|Change From Baseline in Previous Study RA0055 Period 1 in Simplified Disease Activity Index (SDAI) to Week 104 in RA0055 Period 2|"SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm), Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in mm) and C-Reactive Protein (CRP in mg/L). 28 joints are examined where a lower score indicates less disease activity.
The SDAI score ranges from 0 to 86, with a negative value in SDAI change from Baseline indicating an improvement from Baseline."|From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2|"FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses
1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2"||units on a scale||Standard Deviation|Mean
683844|NCT01521923|Secondary|Change From Week 52 in Previous Study RA0055 Period 1 in Clinical Disease Activity Index (CDAI) to Week 104 in RA0055 Period 2|CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm), and Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in mm). 28 joints are examined. CDAI ranges from 0-76 with lower scores indicating less disease activity and higher scores indicating higher disease activity.A negative value in CDAI change from Baseline indicates an improvement from Baseline.|From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2|"FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses
1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2"||units on a scale||Standard Deviation|Mean
683845|NCT01521923|Secondary|Change From Baseline in Previous Study RA0055 Period 1 in Clinical Disease Activity Index (CDAI) to Week 104 in RA0055 Period 2|"CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm), and Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in mm). 28 joints are examined. CDAI ranges from 0-76 with lower scores indicating less disease activity and higher scores indicating higher disease activity.
A negative value in CDAI change from Baseline indicates an improvement from Baseline."|From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2|"FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses
1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2"||units on a scale||Standard Deviation|Mean
683846|NCT01521923|Secondary|Change From Week 52 in Previous Study RA0055 Period 1 in Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) to Week 104 in RA0055 Period 2|"DAS28[ESR] is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x PtGADA, where 28 joints are examined and a lower score indicates less disease activity. DAS28[ESR] ranges from 0-10 with higher values representing higher disease activity.
A negative value in DAS28[ESR] change from Baseline indicates an improvement from Baseline."|From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2|"FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses
1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2"||units on a scale||Standard Deviation|Mean
683847|NCT01521923|Secondary|Change From Baseline in Previous Study RA0055 Period 1 in Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) to Week 104 in RA0055 Period 2|"DAS28[ESR] is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x PtGADA, where 28 joints are examined and a lower score indicates less disease activity. DAS28[ESR] ranges from 0-10 with higher values representing higher disease activity.
A negative value in DAS28[ESR] change from Baseline indicates an improvement from Baseline."|From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2|"FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses
1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2"||units on a scale||Standard Deviation|Mean
683848|NCT01521923|Secondary|Percentage of Subjects Achieving a Good or Moderate European League Against Rheumatism (EULAR) Response at Week 104 in RA0055 Period 2|"Good response is defined as:
DAS28[ESR] <= 3.2 and decrease from Baseline by >1.2;
moderate response is defined as achievement of one of the following:
DAS28[ESR] <= 3.2 and decrease from Baseline > 0.6 and ≤ 1.2
DAS28[ESR] > 3.2 and ≤ 5.1 and decrease from Baseline > 0.6
DAS28[ESR] > 5.1 and decrease from Baseline >1.2.
LOCF= Last Observation Carried Forward"|From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2|"FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses
1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2"||percentage of subjects|||Number
683849|NCT01521923|Secondary|Percentage of Subjects Meeting the 2011 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) Remission Criteria Simplified for Clinical Practice at Week 104 in RA0055 Period 2|"The 2011 ACR/EULAR remission criteria simplified for clinical practice is defined as:
Tender Joint Count (TJC) <= 1, Swollen Joint Count (SJC) <= 1 and Patient's Global Assessment of Disease Activity (PtGADA) <= 10 mm."|Week 104 in RA0055 Period 2|"FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses
1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2"||percentage of subjects|||Number
683850|NCT01521923|Secondary|Percentage of Subjects With Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28[ESR]) < 2.6 at Week 104 in RA0055 Period 2|DAS28[ESR] is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x PtGADA, where 28 joints are examined and a lower score indicates less disease activity.|Week 104 in RA0055 Period 2|"FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses
1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2"||percentage of subjects|||Number
683851|NCT01521923|Secondary|Percentage of Subjects With Simplified Disease Activity Index (SDAI) <= 3.3 at Week 104 in RA0055 Period 2|"SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm), Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in mm) and C-Reactive Protein (CRP in mg/L). 28 joints are examined where a lower score indicates less disease activity.
The SDAI score ranges from 0 to 86, with a negative value in SDAI change from Baseline indicating an improvement from Baseline."|Week 104 in RA0055 Period 2|"FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses
1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2"||percentage of subjects|||Number
683852|NCT01521923|Secondary|Percentage of Subjects With Clinical Disease Activity Index (CDAI) <= 2.8 at Week 104 in RA0055 Period 2|CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm), and Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in mm). 28 joints are examined where a lower score indicates less disease activity.|Week 104 in RA0055 Period 2|"FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses
1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2"||percentage of subjects|||Number
683853|NCT01521923|Secondary|Percentage of Subjects Meeting the 2011 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) Remission Criteria at Week 104 in RA0055 Period 2|"The ACR/EULAR 2011 remission criteria is defined as:
Tender Joint Count (TJC) <= 1, Swollen Joint Count (SJC) <= 1, C-Reactive Protein (CRP) <= 1 mg/dl and Patient's Global Assessment of Disease Activity (PtGADA) <= 10 mm."|Week 104 in RA0055 Period 2|"FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses
1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2"||percentage of subjects|||Number
683854|NCT01521923|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 104 in RA0055 Period 2|The assessments are based on a 70 % or greater improvement from Baseline in previous study RA0055 Period 1 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).|From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2|"FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses
1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2"||percentage of subjects|||Number
683855|NCT01521923|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 104 in RA0055 Period 2|The assessments are based on a 50 % or greater improvement from Baseline in previous study RA0055 Period 1 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).|From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2|"FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses
1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2"||percentage of subjects|||Number
683856|NCT01521923|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 104 in RA0055 Period 2|The assessments are based on a 20 % or greater improvement from Baseline in previous study RA0055 Period 1 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).|From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2|"FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses
1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2"||percentage of subjects|||Number
684060|NCT01519960|Secondary|Percentage of Participants With >15% Drop in Weight Percentile for Age in Group C|The percentage of participants with >15% drop in weight percentile for age from Baseline to each visit was reported.|Weeks 30, 36; FU Weeks 4, 12, 24 (up to 72 weeks overall)|Safety Population.||percentage of participants|||Number
683857|NCT01521923|Secondary|Change From Week 52 in Previous Study RA0055 Period 1 in the Joint Narrowing Score to Week 104 in RA0055 Period 2|Joint space narrowing (JSN) was assessed in 15 locations per hand and 6 locations per foot. Joint space narrowing for each location was scored from 0 to 4, with 0 indicating no narrowing. The minimum possible score for JSN in all 30 hand joints was 0, the maximum possible score for JSN in all 30 hand joints was 120. The minimum possible score for JSN in all 12 feet joints was 0, the maximum possible score for JSN in all 12 feet joints was 48. Thus, the minimum possible total JSN score for hands and feet was 0, the the maximum possible total JSN score for Hands and feet was 168. Higher values represent greater damage.|From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2|"The Radiographic Set Period 2 (RAD2) consisted of those subjects in the FAS2 who had provided valid radiographs at Baseline, at Week 52, and at Week 104 or the Withdrawal Visit.
RAD2 did not include subjects who had received PBO + MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses."||units on a scale||Full Range|Median
683858|NCT01521923|Secondary|Change From Baseline in Previous Study RA0055 Period 1 in the Joint Narrowing Score to Week 104 in RA0055 Period 2|Joint space narrowing (JSN) was assessed in 15 locations per hand and 6 locations per foot. Joint space narrowing for each location was scored from 0 to 4, with 0 indicating no narrowing. The minimum possible score for JSN in all 30 hand joints was 0, the maximum possible score for JSN in all 30 hand joints was 120. The minimum possible score for JSN in all 12 feet joints was 0, the maximum possible score for JSN in all 12 feet joints was 48. Thus, the minimum possible total JSN score for hands and feet was 0, the the maximum possible total JSN score for Hands and feet was 168. Higher values represent greater damage.|From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2|"The Radiographic Set Period 2 (RAD2) consisted of those subjects in the FAS2 who had provided valid radiographs at Baseline, at Week 52, and at Week 104 or the Withdrawal Visit.
RAD2 did not include subjects who had received PBO + MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses."||units on a scale||Full Range|Median
683859|NCT01521923|Secondary|Change From Week 52 in Previous Study RA0055 Period 1 in the Joint Erosion Score to Week 104 in RA0055 Period 2|"Erosions were assessed in 16 locations per hand and 6 joints per foot. Erosions for each hand location were scored from 0 to 5, with 0 indicating no erosion. Scores 1 to 5 may have included combinations of discrete erosion(s) and/or large erosions. Erosions for each foot joint were scored from 0 to 10, with 0 indicating no erosions.
The minimum possible total erosion score for all 32-hand joints was 0, the maximum possible erosion score for all 32-hand joints was 160. The minimum possible total erosion score for all 12-feet joints was 0, the maximum possible erosion score for all 12 feet joints was 120. Thus, the minimum possible total erosion score for hands and feet was 0, the maximum possible total erosion score for hands and feet was 280. Higher values represent greater damage."|From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2|"The Radiographic Set Period 2 (RAD2) consisted of those subjects in the FAS2 who had provided valid radiographs at Baseline, at Week 52, and at Week 104 or the Withdrawal Visit.
RAD2 did not include subjects who had received PBO + MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses."||units on a scale||Full Range|Median
683860|NCT01521923|Secondary|Change From Baseline in Previous Study RA0055 Period 1 in the Joint Erosion Score to Week 104 in RA0055 Period 2|"Erosions were assessed in 16 locations per hand and 6 joints per foot. Erosions for each hand location were scored from 0 to 5, with 0 indicating no erosion. Scores 1 to 5 may have included combinations of discrete erosion(s) and/or large erosions. Erosions for each foot joint were scored from 0 to 10, with 0 indicating no erosions.
The minimum possible total erosion score for all 32-hand joints was 0, the maximum possible erosion score for all 32-hand joints was 160. The minimum possible total erosion score for all 12-feet joints was 0, the maximum possible erosion score for all 12 feet joints was 120. Thus, the minimum possible total erosion score for hands and feet was 0, the maximum possible total erosion score for hands and feet was 280. Higher values represent greater damage."|From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2|"The Radiographic Set Period 2 (RAD2) consisted of those subjects in the FAS2 who had provided valid radiographs at Baseline, at Week 52, and at Week 104 or the Withdrawal Visit.
RAD2 did not include subjects who had received PBO + MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses."||units on a scale||Full Range|Median
683861|NCT01521923|Secondary|Percentage of Subjects With Radiographic Non-progression From Week 52 in Previous Study RA0055 Period 1 to Week 104 in RA0055 Period 2|"Radiographic nonprogression is defined as change in modified Total Sharp Score (mTSS) <= 0.5.
Van der Heijde modified Total Sharp Score (mTSS) is a methodology to assess the degree of joint damage by quantifying the extent of bone erosions and joint space narrowing for 44 and 42 joints, respectively. The mTSS ranges from 0 to 448, with higher scores representing greater damage."|From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2|"The Radiographic Set Period 2 (RAD2) consisted of those subjects in the FAS2 who had provided valid radiographs at Baseline, at Week 52, and at Week 104 or the Withdrawal Visit.
RAD2 did not include subjects who had received PBO + MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses."||percentage of subjects|||Number
683862|NCT01521923|Secondary|Percentage of Subjects With Radiographic Non-progression From Baseline in Previous Study RA0055 Period 1 to Week 104 in RA0055 Period 2|"Radiographic nonprogression is defined as change in modified Total Sharp Score (mTSS) <= 0.5.
Van der Heijde modified Total Sharp Score (mTSS) is a methodology to assess the degree of joint damage by quantifying the extent of bone erosions and joint space narrowing for 44 and 42 joints, respectively. The mTSS ranges from 0 to 448, with higher scores representing greater damage."|From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2|"The Radiographic Set Period 2 (RAD2) consisted of those subjects in the FAS2 who had provided valid radiographs at Baseline, at Week 52, and at Week 104 or the Withdrawal Visit.
RAD2 did not include subjects who had received PBO + MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses."||percentage of subjects|||Number
683898|NCT01521871|Primary|Wound Healing by Numerical Scales for Oedema at Discharge From Hospital.|The evaluation is performed by the use of a previously set numerical scale for oedema (0-1; 0: no elevation - 1: oedema causing > 2 mm elevation). Both arms/groups are evaluated day 2 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.|At departure from Surgical Dep. to the patients home, usually at postop. day 4, 5, 6 or 7|||units on a scale||Standard Deviation|Mean
683863|NCT01521923|Secondary|Change From Week 52 in Previous Study RA0055 Period 1 in Modified Total Sharp Score (mTSS) to Week 104 in RA0055 Period 2|Van der Heijde modified Total Sharp Score (mTSS) is a methodology to assess the degree of joint damage by quantifying the extent of bone erosions and joint space narrowing for 44 and 42 joints, respectively. The mTSS ranges from 0 to 448, with higher scores representing greater damage.|From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2|"The Radiographic Set Period 2 (RAD2) consisted of those subjects in the FAS2 who had provided valid radiographs at Baseline, at Week 52, and at Week 104 or the Withdrawal Visit.
RAD2 did not include subjects who had received PBO + MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses."||units on a scale||Full Range|Median
683864|NCT01521923|Secondary|Change From Baseline in Previous Study RA0055 Period 1 in Modified Total Sharp Score (mTSS) to Week 104 in RA0055 Period 2|Van der Heijde modified Total Sharp Score (mTSS) is a methodology to assess the degree of joint damage by quantifying the extent of bone erosions and joint space narrowing for 44 and 42 joints, respectively. The mTSS ranges from 0 to 448, with higher scores representing greater damage.|From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2|"The Radiographic Set Period 2 (RAD2) consisted of those subjects in the FAS2 who had provided valid radiographs at Baseline, at Week 52, and at Week 104 or the Withdrawal Visit.
RAD2 did not include subjects who had received PBO + MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses."||units on a scale||Full Range|Median
683865|NCT01521923|Secondary|Percentage of Subjects With Disease Activity Score 28 [ESR] (DAS28 [ESR]) < 2.6 at Week 52 in Previous Study RA0055 Period 1 Who Maintain a DAS28 [ESR] < 2.6 From Week 52 in RA0055 Period 1 Through Week 104 in RA0055 Period 2 Without Flaring|DAS28[ESR] is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x PtGADA, where 28 joints are examined and a lower score indicates less disease activity.|From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2|Full Analysis Set Period 2 (FAS2) with Non-Responder Imputation (NRI). FAS2 did not include subjects who had received PBO + MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses.||percentage of subjects|||Number
683866|NCT01521923|Primary|Percentage of Subjects With Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) <= 3.2 at Week 104 in RA0055 Period 2 Without Flaring|This Outcome Measure includes all subjects that have a DAS28 [ESR] <= 3.2 from the start of RA0055 Period 2 (Week 52 of RA0055 Period 1) to Week 104 in RA0055 Period 2 without flaring.|Week 104 in RA0055 Period 2|"FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses
1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2"||percentage of subjects|||Number
683867|NCT01521897|Other Pre-specified|Number of Participants by Pattern of Concomitant Vaccination Sites|Number of participants was counted by each pattern of concomitant vaccination sites at each vaccination time (first to fourth). Vaccination sites of each concomitant vaccines and that of Prevenar™ (7-valent) (PVN7) were defined as follows: upper arm, UA; upper buttock, UB; femour, F; and oral route, O; R, right; L, left; same, same side of the vaccination site of PVN7; and other, other side of the vaccination site of PVN7. PVN7 was vaccinated at upper arm if not stated otherwise. The 1st to 4th represents the first to fourth vaccination of PVN7, respectively.|28 days|The analysis population comprised of participants who had received Prevenar™ (7-valent) at least once and provided the safety data and who did not meet the exclusion criteria for the safety analysis.||participants|||Number
683868|NCT01521897|Other Pre-specified|Number of Participants by Pattern of Concomitant Vaccines|Number of participants was counted by each pattern of concomitant vaccination at each vaccination time (first to fourth). The concomitant vaccines (CVs) used were; vaccines against Haemophilus influenzae type b (Hib), diphtheria and tetanus toxoids and pertussis (DPT), measles and rubella (MR), influenza (Flu), bacille Calmette-Guérin (BCG), vesicular stomatitis Indiana virus (VSV), Mumps, Hepatitis B (HB); and oral polio vaccine (OPV) and inactivated polio vaccine (IPV).|28 days|The analysis population comprised of participants who had received Prevenar™ (7-valent) at least once and provided the safety data and who did not meet the exclusion criteria for the safety analysis.||participants|||Number
683869|NCT01521897|Other Pre-specified|Number of Participants by Vaccination Sites at Each Vaccination Time|Number of participants was counted by vaccination sites at each vaccination time (first to fourth).|28 days|The analysis population comprised of participants who had received Prevenar™ (7-valent) at least once and provided the safety data and who did not meet the exclusion criteria for the safety analysis.||Participants|||Number
683870|NCT01521897|Other Pre-specified|Number of Participants by Month of Age at Each Vaccination Time|Number of participants was counted by month of age at each vaccination time (first to fourth).|28 days|The analysis population comprised of participants who had received Prevenar™ (7-valent) at least once and provided the safety data and who did not meet the exclusion criteria for the safety analysis.||Participants|||Number
683871|NCT01521897|Secondary|Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination|Number of participants with pyrexia (MedDRA/J version 16.0 preferred terms) at each vaccination time (first to fourth) was counted by each pattern of concomitant vaccination. The concomitant vaccines (CVs) used in this survey were; vaccines against Haemophilus influenzae type b (Hib), diphtheria and tetanus toxoids and pertussis (DPT), measles and rubella (MR), influenza (Flu), bacille Calmette-Guérin (BCG), vesicular stomatitis Indiana virus (VSV), Mumps, Hepatitis B (HB); and oral polio vaccine (OPV) and inactivated polio vaccine (IPV).|28 days|The safety analysis population comprised of participants who had received Prevenar™ (7-valent) at least once and provided the safety data and who did not meet the exclusion criteria for the safety analysis.||participants|||Number
683899|NCT01521871|Primary|Wound Healing by Numerical Scales for Oedema Postoperative Day 4.|The evaluation is performed by the use of a previously set numerical scale for oedema (0-1; 0: no elevation - 1: oedema causing > 2 mm elevation). Both arms/groups are evaluated day 2 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.|Postop. day 4|||units on a scale||Standard Deviation|Mean
683872|NCT01521897|Secondary|Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination|Number of participants with pyrexia (MedDRA/J version 16.0 preferred terms) of over 39C° at each vaccination time (first to fourth) was counted by each pattern of concomitant vaccination. The concomitant vaccines (CVs) used in this survey were; vaccines against Haemophilus influenzae type b (Hib), diphtheria and tetanus toxoids and pertussis (DPT), measles and rubella (MR), influenza (Flu), bacille Calmette-Guérin (BCG), vesicular stomatitis Indiana virus (VSV), Mumps, Hepatitis B (HB); and oral polio vaccine (OPV) and inactivated polio vaccine (IPV).|28 days|The safety analysis population comprised of participants who had received Prevenar™ (7-valent) at least once and provided the safety data and who did not meet the exclusion criteria for the safety analysis.||Participants|||Number
683873|NCT01521897|Secondary|Number of Participants With Injection Site Reactions|Injection site reactions (erythema, induration, tenderness, and warmth) were defined by preferred terms of MedDRA/J version 16.0 as follows: erythema for “injection site erythema”; induration for “injection site erythema” and “injection site swelling”; tenderness for ”injection site pain”; and warmth for “injection site warmth”.|28 days|The safety analysis population comprised of participants who had received Prevenar™ (7-valent) at least once and provided the safety data and who did not meet the exclusion criteria for the safety analysis.||Participants|||Number
683874|NCT01521897|Secondary|Number of Participants With Serious Adverse Events|A serious adverse event was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|28 days|The safety analysis population comprised of participants who had received Prevenar™ (7-valent) at least once and provided the safety data and who did not meet the exclusion criteria for the safety analysis.||participants|||Number
683875|NCT01521897|Primary|Number of Participants With Adverse Reactions|An adverse reaction was any untoward medical occurrence which was considered to be related to Prevenar™ (7-valent) in a participant who received Prevenar™ (7-valent). Relatedness to Prevenar™ (7-valent) was assessed by the sponsor (Pfizer Japan Inc.).|28 days|The safety analysis population comprised of participants who had received Prevenar™ (7-valent) at least once and provided the safety data and who did not meet the exclusion criteria for the safety analysis.||participants|||Number
683876|NCT01521884|Other Pre-specified|Spearman Correlation Coefficient Between Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (DAS 28-CRP) and Visual Analog Scale (VAS) Fatigue Score|Spearman correlation coefficient between DAS28-CRP and VAS score (DAS28-CRP vs VAS score) was calculated. DAS28-CRP was calculated from the number of SJC and TJC count using 28 joint count and CRP (mg/L). Total score range: 0-10, higher score= more disease activity. DAS28 (CRP): <3.2= low DA, >3.2 to 5.1 = moderate to high DA and <2.6 = remission and VAS= Participants recorded their fatigue score on a range of 0 to 10, where higher score indicated higher intensity of fatigue.|Baseline, Month 6, 12, 18, 24|ITT population included participants for whom the primary endpoint or 1 of the secondary endpoints could be determined at baseline. Here “n” = participants who were evaluable for this measure for specified component score.||correlation coefficient|||Number
683877|NCT01521884|Other Pre-specified|Spearman Correlation Coefficient Between Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation (DAS 28-ESR) and Visual Analog Scale (VAS) Fatigue Score|Spearman correlation coefficient between DAS28-ESR and VAS fatigue (DAS28-ESR vs VAS score) was calculated. DAS28-ESR calculated from the number of SJC and TJC using the 28 joints count, ESR (mm/hour) and participant's assessment of disease activity VAS (scores ranging 0 [very well] to 100 mm [extremely bad]). Total score range: 0-10, higher score= more disease activity. DAS28-ESR <= 3.2 = low DA, DAS28 > 3.2 to 5.1 = moderate to high DA and VAS fatigue = Participants recorded their fatigue score on a range of 0 to 10, where higher score indicated higher intensity of fatigue.|Baseline, Month 6, 12, 18, 24|ITT population included participants for whom the primary endpoint or 1 of the secondary endpoints could be determined at baseline. Here “n” = participants who were evaluable for this measure for specified component score.||correlation coefficient|||Number
683878|NCT01521884|Other Pre-specified|Pearson Correlation Coefficient Between Arthritis Impact Measurement Scale- Version 2 (AIMS2) Main Components and Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (DAS 28-CRP)|Pearson correlation coefficient between AIMS2 component score and DAS28-CRP score (AIMS2 component score vs DAS28-CRP) was calculated. AIMS2: 78-item questionnaire assessing 12 scales. Each item was scored as 0 (or 1, best situation) to 4 (worst situation). Sub-total score of each of the 12 scales normalized to a maximum of 10. Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain); total score range from 0 to 10, higher scores indicates worse situation DAS28-CRP was calculated from the number of SJC and TJC count using 28 joint count and CRP (mg/L). Total score range: 0-10, higher score= more disease activity. DAS28 (CRP): <3.2= low DA, >3.2 to 5.1 = moderate to high DA and <2.6 = remission.|Baseline, Month 6, 12, 18, 24|ITT population included participants for whom the primary endpoint or 1 of the secondary endpoints could be determined at baseline. Here “n” = participants who were evaluable for this measure for specified component score. The results for social interaction and role components of AIMS2 were not analyzed due to change in planned analysis.||correlation coefficient|||Number
683886|NCT01521884|Primary|Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 18|AIMS2 is a disease-specific measure of physical, social, and emotional well-being. It is a 78-item questionnaire assessing 12 scales: moving capacities, walking and dexterity, hand and fingers movements, arm movements, self-care, household activities, social activities, support of family and friends, joint pain, work, nervous tension and psychological condition (anxiety and depression). Each item was scored as 0 (or 1, best situation) to 4 (worst situation). Sub-total score of each of the 12 scales normalized to a maximum of 10. Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain) with total score range from 0 to 10 for all component scores, where higher scores indicated worse situation.|Month 18|ITT population included participants for whom the primary endpoint or 1 of the secondary endpoints could be determined at baseline. Here “n” = participants who were evaluable for this measure for specified component score. The results for social interaction and role components of AIMS2 were not analyzed due to change in planned analysis.||units on a scale||Standard Deviation|Mean
683879|NCT01521884|Other Pre-specified|Pearson Correlation Coefficient Between Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Components and Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation (DAS 28-ESR)|Pearson correlation coefficient between AIMS2 component score and DAS28-ESR score (AIMS2 component score vs DAS28-ESR) was calculated. AIMS2: 78-item questionnaire assessing 12 scales. Each item was scored as 0 (or 1, best situation) to 4 (worst situation). Sub-total score of each of the 12 scales normalized to a maximum of 10. Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain); total score range from 0 to 10, higher scores indicates worse situation and DAS28-ESR calculated from the number of SJC and TJC using the 28 joints count, ESR (mm/hour) and participant's assessment of disease activity VAS (scores ranging 0 [very well] to 100 mm [extremely bad]). Total score range: 0-10, higher score= more disease activity. DAS28-ESR <= 3.2 = low DA, DAS28 > 3.2 to 5.1 = moderate to high DA.|Baseline, Month 6,1 2, 18, 24|ITT population, Here “n” = participants evaluable for this measure for specified component score and “N” (number of participants analyzed) = participants who were evaluable for this measure. The results for social interaction and role components of AIMS2 were not analyzed due to change in planned analysis.||correlation coefficient|||Number
683880|NCT01521884|Other Pre-specified|Spearman Correlation Coefficient Between Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Components and Visual Analog Scale (VAS) Fatigue Score|Spearman correlation coefficient between AIMS2 component score and VAS fatigue score (AIMS2 component score versus [vs] VAS fatigue) was calculated. AIMS2 : 78-item questionnaire assessing 12 scales. Each item was scored as 0 (or 1, best situation) to 4 (worst situation). Sub-total score of each of the 12 scales normalized to a maximum of 10. Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain); total score range from 0 to 10, higher scores indicates worse situation and VAS score: Participants recorded their fatigue score on a range of 0 to 10, where higher score indicated higher intensity of fatigue.|Baseline, Month 6, 12, 18, 24|ITT population included participants for whom the primary endpoint or 1 of the secondary endpoints could be determined at baseline. Here “n” = participants who were evaluable for this measure for specified component score. The results for social interaction and role components of AIMS2 were not analyzed due to change in planned analysis.||correlation coefficient|||Number
683881|NCT01521884|Secondary|Health Assessment Questionnaire (HAQ) Total Score|HAQ: 20-item participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, reach, grip, hygiene and common activities. Each item scored on 4-point scale, 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as sum of item scores. HAQ total score was 0 to 60 (as used in Belgium), where greater score indicated greater difficulty.|Baseline, Month 6, 12, 18, 24|ITT population included participants for whom the primary endpoint or 1 of the secondary endpoints could be determined at baseline. Here “n” = participants who were evaluable for this measure for specified component score.||units on a scale||Standard Deviation|Mean
683882|NCT01521884|Secondary|Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (DAS 28-CRP)|DAS28-CRP was calculated from the number of swollen joints ( SJC) and tender joints (TJC) count using 28 joint count and CRP (milligram per liter [mg/L]). Total score range: 0-10, higher score= more disease activity. DAS28 (CRP) : <3.2= low disease activity, >3.2 to 5.1 = moderate to high disease activity and less than (<)2.6 = remission.|Baseline, Month 6, 12, 18, 24|ITT population included participants for whom the primary endpoint or 1 of the secondary endpoints could be determined at baseline. Here “n” = participants who were evaluable for this measure for specified component score.||units on a scale||Standard Deviation|Mean
683883|NCT01521884|Secondary|Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (DAS 28-ESR)|DAS28-ESR was calculated from the number of swollen joints (SJC) and tender joints (TJC ) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeter per hour [mm/hour]) and participant's assessment of disease activity visual analog scale (scores ranging 0 [very well] to 100 mm [extremely bad]). Total score range: 0-10, higher score=more disease activity (DA). DAS28-ESR less than equal to (<=) 3.2 = low disease activity, DAS28 greater than (>) 3.2 to 5.1 = moderate to high DA|Baseline, Month 6, 12, 18, 24|ITT population included participants for whom the primary endpoint or 1 of the secondary endpoints could be determined at baseline. Here “n” = participants who were evaluable for this measure for specified component score.||units on a scale||Standard Deviation|Mean
683884|NCT01521884|Secondary|Visual Analog Scale (VAS) Fatigue Score|Participants recorded their fatigue score on a range of 0 to 10, where higher score indicated higher intensity of fatigue.|Baseline, Month 6, 12, 18, 24|ITT population included participants for whom the primary endpoint or 1 of the secondary endpoints could be determined at baseline. Here “n” = participants who were evaluable for this measure for specified component score.||units on a scale||Standard Deviation|Mean
683885|NCT01521884|Primary|Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 24|AIMS2 is a disease-specific measure of physical, social, and emotional well-being. It is a 78-item questionnaire assessing 12 scales: moving capacities, walking and dexterity, hand and fingers movements, arm movements, self-care, household activities, social activities, support of family and friends, joint pain, work, nervous tension and psychological condition (anxiety and depression). Each item was scored as 0 (or 1, best situation) to 4 (worst situation). Sub-total score of each of the 12 scales normalized to a maximum of 10. Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain) with total score range from 0 to 10 for all component scores, where higher scores indicated worse situation.|Month 24|ITT population included participants for whom the primary endpoint or 1 of the secondary endpoints could be determined at baseline. Here “n” = participants who were evaluable for this measure for specified component score. The results for social interaction and role components of AIMS2 were not analyzed due to change in planned analysis.||units on a scale||Standard Deviation|Mean
684061|NCT01519960|Secondary|Percentage of Participants With >15% Drop in Height Percentile for Age in Group C|The percentage of participants with >15% drop in height percentile for age from Baseline to each visit was reported.|Weeks 12, 24, 48; FU Week 24 (up to 72 weeks overall)|Safety Population.||percentage of participants|||Number
683887|NCT01521884|Primary|Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 12|AIMS2 is a disease-specific measure of physical, social, and emotional well-being. It is a 78-item questionnaire assessing 12 scales: moving capacities, walking and dexterity, hand and fingers movements, arm movements, self-care, household activities, social activities, support of family and friends, joint pain, work, nervous tension and psychological condition (anxiety and depression). Each item was scored as 0 (or 1, best situation) to 4 (worst situation). Sub-total score of each of the 12 scales normalized to a maximum of 10. Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain) with total score range from 0 to 10 for all component scores, where higher scores indicated worse situation.|Month 12|ITT population included participants for whom the primary endpoint or 1 of the secondary endpoints could be determined at baseline. Here “N” (number of participants analyzed) = participants who were evaluable for this measure. The results for social interaction and role components of AIMS2 were not analyzed due to change in planned analysis.||units on a scale||Standard Deviation|Mean
683888|NCT01521884|Primary|Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 6|AIMS2 is a disease-specific measure of physical, social, and emotional well-being. It is a 78-item questionnaire assessing 12 scales: moving capacities, walking and dexterity, hand and fingers movements, arm movements, self-care, household activities, social activities, support of family and friends, joint pain, work, nervous tension and psychological condition (anxiety and depression). Each item was scored as 0 (or 1, best situation) to 4 (worst situation). Sub-total score of each of the 12 scales normalized to a maximum of 10. Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain) with total score range from 0 to 10 for all component scores, where higher scores indicated worse situation.|Month 6|ITT population included participants for whom the primary endpoint or 1 of the secondary endpoints could be determined at baseline. Here “n” = participants who were evaluable for this measure for specified component score. The results for social interaction and role components of AIMS2 were not analyzed due to change in planned analysis.||units on a scale||Standard Deviation|Mean
683889|NCT01521884|Primary|Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Baseline|AIMS2 is a disease-specific measure of physical, social, and emotional well-being. It is a 78-item questionnaire assessing 12 scales: moving capacities, walking and dexterity, hand and fingers movements, arm movements, self-care, household activities, social activities, support of family and friends, joint pain, work, nervous tension and psychological condition (anxiety and depression). Each item was scored as 0 (or 1, best situation) to 4 (worst situation). Sub-total score of each of the 12 scales normalized to a maximum of 10. Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain) with total score range from 0 to 10 for all component scores, where higher scores indicated worse situation.|Baseline|ITT population included participants for whom the primary endpoint or 1 of the secondary endpoints could be determined at baseline. Here “n” = participants who were evaluable for this measure for specified component score. The results for social interaction and role components of AIMS2 were not analyzed due to change in planned analysis.||units on a scale||Standard Deviation|Mean
683890|NCT01521871|Primary|Patients´Self Satisfaction.|"The patients` self-satisfaction was evaluated by means of a questionnaire rating the following 3 domains on a numerical (1-5) scale:
Total satisfaction regarding wound healing/wound care. 1 (satisfied) to 5 (dissatisfied)
Satisfaction regarding wound discomfort; pain, itching, paresthesia, pressure etc. 1 (almost no discomfort) to 5 (lot of discomfort)
Satisfaction regarding wound care; suppleness, practicability versus mobilization, showering etc. 1 (almost no practical challenges) to 5 (lot of practical challenges)
Patients' Self Satisfaction score was the sum of three domains, ranges from 3 (completely satisfied) to 15 (completely dissatisfied).
These data were collected at the day of discharge, with guidance from two interviewers."|These data were collected at the day of discharge from hospital (postoperative day 4-8).|||units on a scale||Standard Deviation|Mean
683891|NCT01521871|Primary|TIme Consumption|The specific time required for skin closure (tissue adhesive versus suture) was recorded, counted from initial application of adhesive/intracutaneous suture until final dressing.|The specific time required for skin closure (tissue adhesive versus suture) was recorded, counted from initial application of adhesive/intracutaneous suture until final dressing.|||minutes||Standard Deviation|Mean
683892|NCT01521871|Primary|Wound Healing by Numerical Scales for Gaps at Discharge From Hospital.|The evaluation is performed by the use of a previously set numerical scale for gaps (0: no gap - 3: need for resuture/strips). Both arms/groups are evaluated day 2 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.|At departure from Surgical Dep. to the patients home, usually at postop. day 4, 5, 6 or 7|||units on a scale||Standard Deviation|Mean
683893|NCT01521871|Primary|Wound Healing by Numerical Scales for Gaps Postoperative Day 4.|The evaluation is performed by the use of a previously set numerical scale for gaps (0: no gap - 3: need for resuture/strips). Both arms/groups are evaluated day 2 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.|Postop. day 4|||units on a scale||Standard Deviation|Mean
683894|NCT01521871|Primary|Wound Healing by Numerical Scales for Gaps Postoperative Day 2.|The evaluation is performed by the use of a previously set numerical scale for gaps (0: no gap - 3: need for resuture/strips). Both arms/groups are evaluated day 2 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.|Postop. day 2|||units on a scale||Standard Deviation|Mean
683895|NCT01521871|Primary|Wound Healing by Numerical Scales for Blisters at Discharge From Hospital.|The evaluation is performed by the use of a previously set numerical scale for blisters (0: none - 3: abundant). Both arms/groups are evaluated day 2 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.|At departure from Surgical Dep. to the patients home, usually at postop. day 4, 5, 6 or 7|||units on a scale||Standard Deviation|Mean
683900|NCT01521871|Primary|Wound Healing by Numerical Scales for Oedema Postoperative Day 2.|The evaluation is performed by the use of a previously set numerical scale for oedema (0-1; 0: no elevation - 1: oedema causing > 2 mm elevation). Both arms/groups are evaluated day 2 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.|Postop. day 2|||units on a scale||Standard Deviation|Mean
683901|NCT01521871|Primary|Wound Healing by Numerical Scales for Secretion at Discharge From Hospital.|The evaluation is performed by the use of a previously set numerical scale for secretion ((0-3; 0: totally dry - 3: continuous secretion). Both arms/groups are evaluated day 4 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.|At departure from Surgical Dep. to the patients home, usually at postop. day 4, 5, 6 or 7|||units on a scale||Standard Deviation|Mean
683902|NCT01521871|Primary|Wound Healing by Numerical Scales for Secretion Postoperative Day 4.|The evaluation is performed by the use of a previously set numerical scale for secretion ((0-3; 0: totally dry - 3: continuous secretion). Both arms/groups are evaluated day 4 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.|Postop. day 4|||units on a scale||Standard Deviation|Mean
683903|NCT01521871|Primary|Wound Healing by Numerical Scales for Secretion Postoperative Day 2.|The evaluation is performed by the use of a previously set numerical scale for secretion ((0-3; 0: totally dry - 3: continuous secretion). Both arms/groups are evaluated day 2 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.|Postop. day 2|||units on a scale||Standard Deviation|Mean
683904|NCT01521871|Primary|Wound Healing by Numerical Scales for Rubor at Discharge From Hospital.|The evaluation is performed by the use of a previously set numerical scale for rubor (0–3; 0: pale, 3: typically infectious). Both arms/groups are evaluated day 4 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.|At departure from Surgical Dep. to the patients home, usually at postop. day 4, 5, 6 or 7|||units on a scale||Standard Deviation|Mean
683905|NCT01521871|Primary|Wound Healing by Numerical Scales for Rubor Postoperative Day 4.|The evaluation is performed by the use of a previously set numerical scale for rubor (0–3; 0: pale, 3: typically infectious). Both arms/groups are evaluated day 4 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.|At postop. day 4 (4 days after kidney donation)|||units on a scale||Standard Deviation|Mean
683906|NCT01521871|Primary|Wound Healing by Numerical Scales for Rubor Postoperative Day 2.|The evaluation is performed by the use of a previously set numerical scale for rubor (0–3; 0: pale, 3: typically infectious). Both arms/groups are evaluated day 2 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.|At postoperative day 2 (2 days after kidney donation)|||units on a scale||Standard Deviation|Mean
683907|NCT01521845|Secondary|MACE(Major Adverse Cardiac Effect) Defined as Need for Target Revascularization, Myocardial Infarction and Death||30 days|||participants|||Number
683908|NCT01521845|Primary|Inflammation Marker (CRP)|difference between study and control group in 8 and 24 hrs after percutaneous coronary intervention|8 and 24 hrs after percutaneous coronary intervention|||mg/l||Inter-Quartile Range|Median
683909|NCT01521845|Primary|Cardiac Necrosis Biomarkers (CKMB, Troponin I)|difference between study and control group in 8 and 24 hrs after percutaneous coronary intervention|8 and 24 hrs after percutaneous coronary intervention|||ng/ml||Inter-Quartile Range|Median
683910|NCT01521780|Secondary|Expression Levels of Low Density Lipoprotein Receptor (LDL-R) in Resected HCC and Adjacent Liver From Whole Tissue Sections.|Resected tumors and adjacent tissues were fixed in FFPE blocks, which were used to prepare multiple serial slide sections. The sections were to be analyzed for LDL-R protein by automated image analysis.|Visit 3, approximately 7 days after screening Visit 1.|Due to early termination of the study, the low number of samples were not assayed and efficacy analyses were not performed.|||||
683911|NCT01521780|Secondary|Expression Levels of Beta-catenin Protein From CNB Equivalents of Liver Adjacent to HCC.|Tissues adjacent to resected tumors were fixed in FFPE blocks, which were used to prepare multiple serial slide sections. The sections were to be analyzed for beta-catenin protein by automated image analysis.|Visit 3, approximately 7 days after screening Visit 1.|Due to early termination of the study, the low number of samples were not assayed and efficacy analyses were not performed.|||||
683912|NCT01521780|Secondary|Expression Levels of Beta-catenin mRNA From CNB Equivalents of Liver Adjacent to HCC.|Tissues adjacent to resected tumors were fixed in FFPE blocks, which were used to prepare multiple serial slide sections. The sections were to be analyzed for beta-catenin mRNA by qRT-PCR.|Visit 3, approximately 7 days after screening Visit 1.|Due to early termination of the study, the low number of samples were not assayed and efficacy analyses were not performed.|||||
683913|NCT01521780|Secondary|Median Apparent Diffusion Coefficient (Median ADC) of Tumors From Repeated MRI Measurements of HCC.|Two volumetric MRI and diffusion weighted (DW) MRI scans were performed without contrast on each participant. The two scans were separated by 10 to 15 minutes, and each scan was read by a separate reader to derive a Median ADC for each tumor. The mean of the Median ADCs is presented based on tumours as observation units.|Visit 2, approximately 7 days after screening Visit 1.|Eleven participants underwent MRI and DW MRI scans and only eight of their tumors were deemed measurable by both readers for analysis. Participants in both the Imaging and Imaging/Pathology treatment groups were combined for this analysis, whereas participants in the Pathology only treatment group were not analyzed for this outcome measure.||um^2/s|Participants|Standard Deviation|Mean
683958|NCT01520922|Secondary|Number of Participants With an Adverse Event of Any Infusion Reactions (IR) or Serious Infusion Reactions (SIR)|An Infusion reaction is defined as events occurring after the beginning of an infusion of ofatumumab or within 24 hours following the end of an infusion of bendamustine.|From the first dose of study medication to 60 days after the last dose of study medication (up to 24 hours after last dose of study treatment)|Safety Population: All subjects who receive at least one dose of study medication.||Participants|||Number
683914|NCT01521780|Secondary|Tumor Volumes From Repeated MRI Measurements of HCC.|Two volumetric MRI and diffusion weighted (DW) MRI scans were performed without contrast on each participant. The two scans were separated by 10 to 15 minutes, and each scan was read by a separate reader to determine the volume of each tumor. The mean of log tumor volume is presented, based on tumors as observation units.|Visit 2, approximately 7 days after screening Visit 1.|Eleven participants underwent MRI and DW MRI scans and only ten of their tumors were deemed measurable by both readers for analysis. Participants in both the Imaging and Imaging/Pathology treatment groups were combined for this analysis, whereas participants in the Pathology only treatment group were not analyzed for this outcome measure.||log cm^3|Participants|Standard Deviation|Mean
683915|NCT01521780|Primary|Expression Levels of Beta-catenin Protein From Core Needle Biopsy (CNB) Equivalents of Resected HCC.|Resected tumors were fixed in FFPE blocks, which were used to prepare multiple serial slide sections. The sections were to be analyzed for beta-catenin protein by automated image analysis.|Visit 3, approximately 7 days after screening Visit 1.|Due to early termination of the study, the low number of samples were not assayed and efficacy analyses were not performed.|||||
683916|NCT01521780|Primary|Expression Levels of Beta-catenin mRNA From Core Needle Biopsy (CNB) Equivalents of Resected HCC.|Resected tumors were fixed with formalin in paraffin embedded (FFPE) blocks, which were used to prepare multiple serial slide sections. The sections were to be analyzed for beta-catenin messenger RNA (mRNA) by quantitative reverse transcription polymerase chain reaction (qRT-PCR).|Visit 3, approximately 7 days after screening Visit 1.|Due to early termination of the study, the low number of samples were not assayed and efficacy analyses were not performed.|||||
683917|NCT01521559|Secondary|Change From Baseline in the National Eye Institute Visual Function Questionnaire - 25 (NEI VFQ-25) Questionnaire Total Score at Week 24 - LOCF|The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales that are all scored from 0-100. Near activities are defined as reading ordinary print in newspapers, performing work or hobbies requiring near vision, or finding something on a crowded shelf.|Baseline to week 24|FAS||scores on a scale||Standard Deviation|Mean
683918|NCT01521559|Secondary|Change From Baseline in Central Retinal Thickness (CRT) at Week 24 - LOCF|CRT was evaluated at every visit from baseline through week 24 using spectral domain Optical Coherence Tomography (OCT).|Baseline to week 24|FAS||microns||Standard Deviation|Mean
683919|NCT01521559|Secondary|Change From Baseline to Week 24 in BCVA Score - LOCF|Best corrected visual acuity (BCVA) was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at every visit from baseline through week 24 - Last observation carried forward (LOCF) method was used to impute missing data.|Baseline to Week 24|FAS||letters correctly read||Standard Deviation|Mean
683920|NCT01521559|Primary|Participants Who Gained at Least 15 Letters in Best Corrected Visual Acuity (BCVA) at Week 24 - LOCF|Best corrected visual acuity (BCVA) was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at every visit from baseline through week 24. Last observation carried forward (LOCF) method was used to impute missing data.|Baseline to week 24|FAS||participants|||Number
683921|NCT01521546|Primary|12-month Change in Myocardial Strain|a sensitive measurement of heart function using cardiac MRI, change was 12 months minus baseline.|baseline and 12 months|||percent change in heart dimension||Inter-Quartile Range|Median
683922|NCT01521507|Secondary|Stage 2 Mean Total OSDI Score at 12 Months|Dry eye symptoms assessed using the OSDI questionnaire were sensitivity to light, grittiness, pain or soreness, blurred vision and poor vision. The questionnaire evaluated the frequency problems with the eyes limited performance in reading, driving at night, working with a computer or bank machine, and watching television. Also, the frequency that eyes felt uncomfortable was assessed in windy conditions, areas with low humidity, and air-conditioned areas. Frequency scale was 0 (none of the time), 1 (some of the time), 2 (half of the time), 3 (most of the time), and 4 (all of the time). The total OSDI score was calculated as the sum of frequency scores for all symptoms multiplied by 25 and divided by the number of questions answered with a range from 0 to 100. A lower total OSDI score represents less disability from dry eye symptoms. The total OSDI score at 12 Months was compared across subgroups, as defined below.|12 Months|Intent to Treat (All participants who received at least a partial LipiFlow treatment or Crossover LipiFlow treatment and had data available at 12 Months). The Two LipiFlow treatments subgroup was not analyzed because the sample size (n<5) was too small for meaningful analysis.||units on a scale||95% Confidence Interval|Mean
683923|NCT01521507|Secondary|Stage 1 Mean Change in Total OSDI Score From Baseline to 3 Months|Dry eye symptoms assessed using the OSDI questionnaire were sensitivity to light, grittiness, pain or soreness, blurred vision and poor vision. The questionnaire evaluated the frequency problems with the eyes limited performance in reading, driving at night, working with a computer or bank machine, and watching television. Also, the frequency that eyes felt uncomfortable was assessed in windy conditions, areas with low humidity, and air-conditioned areas. The frequency scale was 0 (none of the time), 1 (some of the time), 2 (half of the time), 3 (most of the time), and 4 (all of the time). The total OSDI score was calculated as the sum of frequency scores for all symptoms multiplied by 25 and divided by the number of questions answered with a range from 0 to 100. A lower total OSDI score represents less disability from dry eye symptoms. To be eligible for the study, the Baseline total OSDI score must have been 13 points or higher in each eye. Change=3 Months score-Baseline score.|Baseline, 3 Months|Intent to Treat Population (All participants who were randomized and received at least partial device treatment or used warm compress at least once and had data available at 3 Months).||units on a scale||95% Confidence Interval|Mean
683924|NCT01521507|Primary|Stage 2 Mean Total Meibomian Gland Score at 12 Months|To assess the meibomian glands, the secretion characteristics from 15 gland orifices along the lower eyelid were evaluated under a slit lamp biomicrosope using a handheld instrument, Meibomian Gland Evaluator, to apply gentle standardized pressure to the eyelid margin. Expressed secretion characteristics were graded on a scale of 3 (clear liquid secretion), 2 (cloudy liquid secretion), 1 (inspissated/toothpaste consistency), and 0 (no secretion). Total meibomian gland score was calculated based on the sum of the secretion grades for all 15 glands over a range from 0 to 45 with a higher score reflecting less meibomian gland dysfunction. The total meibomian gland score at 12 Months was compared across subgroups, as defined below.|12 Months|Intent to Treat Population (All participants who received at least partial LipiFlow or Crossover LipiFlow treatment and had data available at 12 Months). Two LipiFlow treatments subgroup was not analyzed because sample size was too small (n<5) for meaningful analysis.||units on a scale||95% Confidence Interval|Mean
683925|NCT01521507|Primary|Stage 1 Mean Change in Total Meibomian Gland Score From Baseline to 3 Months|To assess the meibomian glands, the secretion characteristics from 15 gland orifices along the lower eyelid were evaluated under a slit lamp biomicrosope using a handheld instrument, Meibomian Gland Evaluator, to apply gentle standardized pressure to the eyelid margin. Expressed secretion characteristics were graded on a scale of 3 (clear liquid secretion), 2 (cloudy liquid secretion), 1 (inspissated/toothpaste consistency), and 0 (no secretion). Total meibomian gland score was calculated based on the sum of the secretion grades for all 15 glands over a range from 0 to 45 with a higher score reflecting less meibomian gland dysfunction. To be eligible for the study, the Baseline total meibomian gland score must have been 12 or less in each eye. Change = 3 Month score - Baseline Score.|Baseline and 3 Months|Intent to Treat Population (All Participants who were randomized and received at least partial LipiFlow treatment or used warm compress therapy at least once and had data available at 3 Months).||units on a scale||95% Confidence Interval|Mean
683926|NCT01521364|Secondary|Area Under the Time Concentration Curve (AUC0-12h) of Linezolid in Saliva.|The data will be used to clinically validate the analysis linezolid in saliva as surrogate marker for linezolid in plasma.|At week 3 (after co-administration of 250mg clarithromycin)||||||
683927|NCT01521364|Secondary|Pharmacokinetic Parameters, e.g. Tmax, T1/2, Cmax, Cmin, Cl, of Anti-TB Drugs That Are Co-administered as Part of the Continued Standard Care.||At week 1 (baseline), week 3 (250mg clarithromycin) and week 5 (500mg clarithromycin)||||||
683928|NCT01521364|Secondary|Number of Patients With Adverse Events (AEs)|To assess short-term safety and tolerability when combining linezolid (LIN) with clarithromycin (CLA) by monitoring AEs, i.e. gastro-intestinal effects, hyperlactatemia, haematological abnormalities and neuropathy.|Up to week 6|No serious adverse events||participants|||Number
683929|NCT01521364|Secondary|Linezolid (LIN) and Clarithromycin (CLA) Pharmacokinetic Parameters, e.g. Tmax, Cmax, Cmin, T1/2, Cl.||At week 1 (baseline), week 3 (250mg clarithromycin), and week 5 (500mg clarithromycin) and week 6 (baseline).||||||
683930|NCT01521364|Primary|Area Under the Time Concentration Curve (AUC0-12h) of Linezolid in Plasma After Addition of 0mg, 250mg, or 500mg Clarithromycin (CLA).|"The AUCs of linezolid will be measured at 3 time points after addition of 3 different clarithromycin dosages.
Samples were obtained before doseing and 1h, 2h, 3h, 4h, 8h, and 12h after administration of linezolid (and claritromycin depending on the period)."|At week 1 (baseline), week 3 (250mg clarithromycin), and week 5(500mg clarithromycin).|||mg*h/L||Inter-Quartile Range|Median
683931|NCT01521260|Secondary|Complications and Adverse Events||baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)||||||
683932|NCT01521260|Secondary|Implant Failure|defined as implant mobility of previously clinically osseointegrated implants and removal of non-mobile implants because of progressive marginal bone loss or infection|baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)||||||
683933|NCT01521260|Secondary|Marginal Soft Tissue Recession||baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)||||||
683934|NCT01521260|Secondary|Presence of Calculus||baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)||||||
683935|NCT01521260|Secondary|Presence of Plaque||baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)||||||
683936|NCT01521260|Secondary|Radiographic Marginal Bone Level on Standardized Intraoral Radiographs||baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)||||||
683937|NCT01521260|Secondary|Microbiological Composition of the Peri-implant Sulcus||baseline (T0), 3 and 12 months after intervention (T3, T12)||||||
683938|NCT01521260|Secondary|Suppuration on Probing||baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)||||||
683939|NCT01521260|Secondary|Probing Pocket Depth||baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)||||||
683940|NCT01521260|Secondary|Bleeding on Probing||baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)||||||
683941|NCT01521260|Primary|Change in Total Bacterial Load on the Exposed Implant Surface|Total bacterial load as obtained by sweeping a microbrush across the implant surface after flap deflection. Samples are obtained immediately after flap deflection and granulation tissue removal AND after the decontamination procedure (mechanical debridement, rinsing of the implant surface using the placebo or chlorhexidine solution, saline rinsing) but before flap closure. The log-transformed mean change in bacterial load is calculated (difference between the two time points --> difference in sample BEFORE decontamination and AFTER decontamination procedure).|During the surgical procedure: 1. immediately after flap deflection and granulation tissue removal AND 2. after the decontamination procedure but before flap closure.|||log (colony forming units/ml)|Participants|Standard Deviation|Log Mean
683942|NCT01521143|Secondary|Part B - Progression-free Survival|Progression-free survival was defined as the number of days from Baseline and the documented disease progression as defined by response evaluation criteria in solid tumors (RECIST) or death, whichever occurred earlier. Disease progression was defined as any measurable new lesion(s) that were accurately measured in at least 1 dimension. Any new lesion(s) with a minimum size of 20 mm were deemed as unequivocal (ie, clear or definite) progression. Any new lesion(s) with a minimum size of 15 mm but smaller than 20 mm were considered equivocal progression and had to be confirmed by a follow-up radiological procedure.|Baseline to the end of the study (up to 3 years, 2 months)|Intent-to-treat population: All participants who were randomized to a treatment group. The data for this Outcome Measure were not analyzed since the study was terminated early.|||||
683943|NCT01521143|Secondary|Part B - Time to Next Treatment|Time to next treatment was defined as the number of days from Baseline to the date when the next treatment for epithelial ovarian cancer was started.|Baseline to the end of the study (up to 3 years, 2 months)|Intent-to-treat population: All participants who were randomized to a treatment group. The data for this Outcome Measure were not analyzed since the study was terminated early.|||||
683944|NCT01521143|Secondary|Part B - Overall Survival|Overall survival was defined as the number of days from Baseline to the date of death from any cause.|Baseline to the end of the study (up to 3 years, 2 months)|Intent-to-treat population: All participants who were randomized to a treatment group. The data for this Outcome Measure were not analyzed since the study was terminated early.|||||
684076|NCT01519960|Secondary|Percentage of Participants With HBsAg Seroconversion at EOT in Group C|HBsAg seroconversion was defined as loss of HBsAg and the presence of anti-HBs. The percentage of participants with HBsAg seroconversion at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|Safety Population.||percentage of participants||95% Confidence Interval|Number
683945|NCT01521143|Secondary|Part A - Progression-free Survival|Progression-free survival was defined as the number of days from Baseline and the documented disease progression as defined by response evaluation criteria in solid tumors (RECIST) or death, whichever occurred earlier. Disease progression was defined as any measurable new lesion(s) that were accurately measured in at least 1 dimension. Any new lesion(s) with a minimum size of 20 mm were deemed as unequivocal (ie, clear or definite) progression. Any new lesion(s) with a minimum size of 15 mm but smaller than 20 mm were considered equivocal progression and had to be confirmed by a follow-up radiological procedure.|Baseline to the end of the study (up to 3 years, 2 months)|Intent-to-treat population: All participants who were randomized to a treatment group. The data for this Outcome Measure were not analyzed since the study was terminated early.|||||
683946|NCT01521143|Secondary|Part A - Time to Next Treatment|Time to next treatment was defined as the number of days from Baseline to the date when the next treatment for epithelial ovarian cancer was started.|Baseline to the end of the study (up to 3 years, 2 months)|Intent-to-treat population: All participants who were randomized to a treatment group. The data for this Outcome Measure were not analyzed since the study was terminated early.|||||
683947|NCT01521143|Primary|Part A - Overall Survival|Overall survival was defined as the number of days from Baseline to the date of death from any cause.|Baseline to the end of the study (up to 3 years, 2 months)|Intent-to-treat population: All participants who were randomized to a treatment group. The data for this Outcome Measure were not analyzed since the study was terminated early.|||||
683948|NCT01521026|Secondary|Hopkins Verbal Learning Test Percent Retained|"Verbal list learning task with three learning trials and a delay trial. Percent retained refers to the percentage of items recalled at the delay trial, compared to the third learning trial.
Score ranges from 0-100. Higher scores represent better performance."|3 months|||units on a scale||Standard Deviation|Mean
683949|NCT01521026|Primary|UCSD Performance-based Skills Assessment Total Score (Measures Functional Capacity)|Performance-based measure of functional capacity in five domains: Communication, Finance, Recreation Planning, Transportation, and Household Chores Scale ranges from 0-100. Subscales are summed to yield the total score. Higher scores represent better performance.|3 months|||units on a scale||Standard Deviation|Mean
683950|NCT01520987|Primary|Tmax of BIA 9-1067 - Time Taken to Reach Maximum Observed Plasma Concentration of BIA 9-1067 (Day 10)|"Tmax of BIA 9-1067 - Time Taken to Reach Maximum Observed Plasma Concentration of BIA 9-1067 following Last (Day 10) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects.
Blood samples collected for PK analysis at the following timepoints: Day 10 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, and 144 hours post-dose"|Day 10|||hours||Full Range|Median
683951|NCT01520987|Primary|Tmax of BIA 9-1067 - Time Taken to Reach Maximum Observed Plasma Concentration of BIA 9-1067 (Day 1)|"Tmax of BIA 9-1067 - time taken to reach maximum observed plasma concentration following single (Day 1) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects.
Blood samples collected for PK analysis at the following timepoints: on Day 1 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post-dose"|Day 1|||hours||Full Range|Median
683952|NCT01520987|Primary|AUC0-∞ - Area Under the Concentration of BIA 9-1067-time Curve (AUC) From Time Zero to Infinity (Day 10)|"AUC0-∞ - Area Under the Concentration of BIA 9-1067-time Curve (AUC) From Time Zero to Infinity following Last (Day 10) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects.
Blood samples collected for PK analysis at the following timepoints: Day 10 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, and 144 hours post-dose"|Day 10|||ng.h/mL||Standard Deviation|Mean
683953|NCT01520987|Primary|AUC0-∞ - Area Under the Concentration of BIA 9-1067-time Curve (AUC) From Time Zero to Infinity (Day 1)|AUC0-∞ - area under the concentration of BIA 9-1067-time curve (AUC) from time zero to infinity following single (Day 1) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects Blood samples collected for PK analysis at the following timepoints: on Day 1 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post-dose|Day 1|||ng.h/mL||Standard Deviation|Mean
683954|NCT01520987|Primary|AUC0-t - Area Under the Concentration-time Curve (AUC) From Time Zero to Last Time Point With Concentrations Above the Lower Limit of Quantitation of BIA 9-1067 (Day 10)|"AUC0-t - Area Under the Concentration-time Curve (AUC) From Time Zero to Last Time Point With Concentrations Above the Lower Limit of Quantitation of BIA 9-1067 following Last (Day 10) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects.
Blood samples collected for PK analysis at the following timepoints: Day 10 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, and 144 hours post-dose"|Day 10|||ng.h/mL||Standard Deviation|Mean
683955|NCT01520987|Primary|AUC0-t - Area Under the Concentration-time Curve (AUC) From Time Zero to Last Time Point With Concentrations Above the Lower Limit of Quantitation of BIA 9-1067 (Day 1)|"AUC0-t - area under the concentration-time curve (AUC) from time zero to last time point with concentrations above the lower limit of quantitation of BIA 9-1067 following single (Day 1) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects.
Blood samples collected for PK analysis at the following timepoints: on Day 1 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post-dose."|Day 1|||ng.h/mL||Standard Deviation|Mean
683956|NCT01520987|Primary|Cmax of BIA 9-1067 - Maximum Observed Plasma Concentration of BIA 9-1067 (Day 10)|"Cmax - maximum observed plasma concentration following Last (Day 10) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects.
Blood samples collected for PK analysis at the following timepoints: Day 10 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, and 144 hours post-dose"|Day 10|||ng/mL||Standard Deviation|Mean
683957|NCT01520987|Primary|Cmax of BIA 9-1067 - Maximum Observed Plasma Concentration of BIA 9-1067 (Day 1)|Cmax - maximum observed plasma concentration following single (Day 1) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects Blood samples collected for PK analysis at the following timepoints: on Day 1 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post-dose.|Day 1|||ng/mL||Standard Deviation|Mean
683959|NCT01520922|Secondary|Number of Participants With Zeta-chain-associated Protein Kinase (ZAP) 70 Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment|ZAP-70 is a protein normally expressed near the surface membrane of T cells and natural killer cells. ZAP-70 in B cells is used as a prognostic marker in identifying different forms of CLL. Participants with ZAP-70 testing results intermediate (Int), positive (Pos) and negative (Neg) at Baseline and who had a clinical response after last dose of study treatment are provided. Clinical responses included complete remission (CR), complete response with incomplete bone marrow recovery (CRi), nodular partial remission (nPR), partial remission (PR), disease progression (PD), and stable disease (SD). The participants with a PR, CRi, PR or nPR are called responders and the participants with SD and PD are called non-responders.|From the start of study treatment until earliest date of disease progression or death (up to 3 months following last dose of study treatment)|ATS Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).||Participants|||Number
683960|NCT01520922|Secondary|Number of Participants With the Indicated Immunoglobulin Heavy Chain Variable Region (IgVH) Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment|Participants with IgVH mutation results as mutated and unmutated status and clinical response after last dose of study treatment were provided. Clinical responses included complete remission (CR), complete response with incomplete bone marrow recovery (CRi), nodular partial remission (nPR), partial remission (PR), disease progression (PD), and stable disease (SD). The participants with a PR, CRi, PR or nPR are called responders and the participants with SD and PD are called non-responders.|From the start of study treatment until earliest date of disease progression or death (up to up to 3 months following last dose of study treatment)|ATS Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).||Participants|||Number
683961|NCT01520922|Secondary|Number of Participants With the Indicated Beta 2 Microglobulin (B2M) at Baseline Who Also Had a Clinical Response After the Last Dose of Study Treatment|Participants with B2M concentration of <=4000 µg/L and >4000 µg/L at Baseline and who had clinical response after the last dose of study treatment were provided. Clinical responses included complete remission (CR), complete response with incomplete bone marrow Recovery (CRi), nodular partial remission (nPR), and partial remission (PR), disease progression (PD), and stable disease (SD). The participants with a PR, CRi, PR or nPR are called responders and the participants with SD and PD are called non-responders.|From the start of study treatment until earliest date of disease progression or death (up to up to 3 months following last dose of study treatment)|ATS Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).||Participants|||Number
683962|NCT01520922|Secondary|Number of Participants With the Indicated Cytogenetics Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment|Cytogenetics refers to the study of numerical and structural chromosomal abnormalities. Cytogenetics (analyzed by fluorescent in situ hybridization [FISH]) of 17p deletion, 11q deletion, 17p or 11q deletions, 6q- or +12q or 13q- deletions, and no aberration at Baseline were summarized by clinical responses after the last dose of study treatment. Clinical responses included complete remission (CR), nodular partial remission (nPR), complete response with incomplete bone marrow Recovery (CRi), partial remission (PR), disease progression (PD), and stable disease (SD). The participants with a PR, CRi, PR or nPR are called responders and the participants with SD and PD are called non-responders.|From the start of study treatment until earliest date of disease progression or death (up to up to 3 months following last dose of study treatment)|ATS Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).||Participants|||Number
683963|NCT01520922|Secondary|Number of Participants With the Indicated Reduction in Organomegaly (Spleen and Liver)|Organomegaly is the abnormal enlargement of organs. Physical examination of the liver (L) and spleen (S) were done at Screening (SCR), C3D1, C6D1, 12-Month F/U, 24-Month F/U and 36-Month F/U. The result of the physical examination of the liver (L) and spleen (S) was presented as normal (NOR), enlarged (EL) and not assessed (NOA).|Screening (Scr), Cycle 3 Day 1 (C3D1), Cycle 6 Day 1 (C6D1), 12, 24 and 36 -Month Follow-Up (F/U)|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).||Participants|||Number
683964|NCT01520922|Secondary|Maximum Decrease in Sum of the Product of the Diameter (SPD) From Baseline in Participants With Lymphadenopathy at Baseline|Lymph nodes were evaluated by physical examination which involved recording the diameter in two planes (sum of the product of the diameter [SPD]) of the largest palpable node in each of the following sites: cervical, axillary, supraclavicular, inguinal and femoral. Lymphadenopathy is defined as lymph nodes with the largest diameter greater than 1.5 centimeters. The maximum reduction in SPD from Baseline at C2D1, C3D1, C4D1, C5D1, C6D1, 3-Month F/U, 6-Month F/U and 9-Month F/U are provided.|Baseline, Cycle 2 Day 1 (C2D1), Cycle 3 Day 1 (C3D1), Cycle 4 Day 1 (C4D1), Cycle 5 Day 1 (C5D1), Cycle 6 Day 1 (C6D1), 3-Month Follow-Up (F/U), 6-Month F/U and 9-Month F/U|ATS Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).||cm^2 (centimeters squared)||Standard Deviation|Mean
683965|NCT01520922|Secondary|Number of Participants With Confirmed Positive Response for Human Anti-human Antibodies (HAHA) at the Indicated Time Points|The presence of HAHA in human serum was determined using a validated electrochemiluminescent assay in a multi-tier assay format. All samples were first assessed in a screening (SCR) assay, and the potential positive (Pos) samples were further tested in the confirmation (CNF) assays. Confirmed positives were reported as HAHA positive and titer was determined for each positive sample. The drug tolerance of the HAHA assay is 200 microgram/milliliter (µg/mL); thus, samples that tested negative in the assay and had ofatumumab concentrations no more than 200 µg/mL were considered as conclusive negative (C Neg) results.|Cycle 1 Day 1 (C1D1), Cycle 6 Day 1 (C6D1), 6-Month Follow-up (F/U), and any post-dose time point|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).||Participants|||Number
684018|NCT01520909|Primary|Number of Participants Achieving a Platelet Count >=50 Giga Cells Per Liter (Gi/L) for at Least 6 Out of 8 Weeks, Between Weeks 5 and 12 of Part 1|Participants who achieved a platelet count >=50 Gi/L for at least 6 out of 8 weeks, between Weeks 5 and 12 of Part 1, were reported.|From Week 5 up to Week 12 of Part 1|Intent-to-Treat (ITT) Population: all randomized participants. The ITT Population was the primary population used for assessing efficacy.||Participants|||Number
683966|NCT01520922|Secondary|Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)|The ECOG performance status scales and criteria are used by doctors and researchers to assess how a participant's disease is progressing, assess how the disease affects the daily living abilities of the participant, and determine appropriate treatment and prognosis. Grade 0, fully active, able to carry on all pre-disease performance without restriction. Grade 1, restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. Grade 2, ambulatory and capable of all selfcare, but unable to carry out any work activities; up and about more than 50% of waking hours. Grade 3, capable of only limited selfcare; confined to bed or chair more than 50% of waking hours. Grade 4, completely disabled; cannot carry on any selfcare; totally confined to bed or chair. Grade 5, dead.|Baseline (BL), Cycle 3 Day 1 (C3D1), Cycle 6 Day 1 (C6D1), 12, 24 and 36 month follow up (F/U)|Safety Population. All subjects who receive at least one dose of study medication.. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).||Participants|||Number
683967|NCT01520922|Secondary|Number of Participants With the Indicated Constitutional or B-symptoms|Participants with the indicated constitutional or B-symptoms (night sweats, weight loss, fever or extreme fatigue) were presented for different time points.|Screening (SCR), Cycle 3 Day 1 (C3D1), Cycle 6 Day 1 (C6D1), 12, 24 and 36 Month Follow-up (F/U)|Safety Population: All subjects who receive at least one dose of study medication. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).||Participants|||Number
683968|NCT01520922|Secondary|Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Event of Infection|Participants with the indicated Grade 3 or Grade 4 adverse event of infection are presented. AEs were graded according to the NCI CTCAE grade, version 4.0 (1, mild; 2, moderate; 3, severe; 4, life-threatening/disabling; 5, death).|From first dose of study medication to 60 days after the last dose of study medication (if the event is considered as an AE), or up to 3 years after the last dose of study treatment or until the time of the next anti-CLL therapy, if considered a SAE|Safety Population: All subjects who receive at least one dose of study medication.||Participants|||Number
683969|NCT01520922|Secondary|Number of Participants With the Indicated Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, and Thrombocytopenia), as Assessed by the Investigator|Participants with a Grade 3 or Grade 4 myelosuppression (anemia, neutropenia, and thrombocytopenia) are presented. Myelosuppression is defined as the decrease in the ability of the bone marrow to produce blood cells. AEs were graded according to NCI common terminology criteria for adverse events (CTCAE) grade, version 4.0 (1, mild; 2, moderate; 3, severe; 4, life-threatening/disabling; 5, death).|From the first dose of study medication to 60 days after the last dose of study medication|Safety Population||Participants|||Number
683970|NCT01520922|Secondary|Number of Participants With Autoimmune Hemolytic Anaemia (AIHA) Disease|"AIHA is a disease where the body's immune system fails to recognize red blood cells as self and begins destroying these red blood cells. The number of participants diagnosed with AIHA are presented."|From first dose of study medication to 60 days after the last dose of study medication (if the event is considered as an AE), or up to 3 years after the last dose of study treatment or until the time of the next anti-CLL therapy, if considered a SAE|Safety Population All subjects who receive at least one dose of study medication.||Participants|||Number
683971|NCT01520922|Secondary|Number of Participants Who Received no Transfusion or at Least One Transfusion During the Study|Participants who received no transfusion and at least one transfusion during the study are presented. Participants who took any blood products are counted in this table.|From start of treatment until earliest date of disease progression or death (up to 3 years after the last dose of study treatment)|Safety Population: All subjects who receive at least one dose of study medication.||Participants|||Number
683972|NCT01520922|Secondary|Number of Participants Who Were Negative or Positive for Minimal Residual Disease (MRD) and Achieved a Bone Marrow Biopsy Confirmed Complete Response (CR) up to 36-Month Follow-up|MRD refers to small number of leukemic cells that remain in the participant during treatment or after treatment at the time the participant achieved a confirmed CR. MRD analysis was performed for the partcipants who were suspected of achieving a primary endpoint CR. Analysis of CD5+ CD19+ was performed on the bone marrow aspirate sample obtained no sooner than 2 months following the last dose of study treatment. MRD results were reported as negative or positive. The absence of MRD (negative MRD) is defined as less than one CLL cell per 10000 leukocytes.|3 month follow up to the 36 Month Follow-up (in 3 month interval)|ATS Population. Number of subjects who had CR with bone marrow confirmation are included. Only those participants with data available at the specified time points were analyzed.||Participants|||Number
683973|NCT01520922|Secondary|Change From Baseline in Cluster of Differentiation (CD) CD5-CD19+ Cell Counts up to 36 Months|CD5-CD19+ cells were counted by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus. Baseline CD5- CD19+ cell count value is the last pre-dose assessment values performed on cycle 1 Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline, 3-Month Follow-up to 36-Month Follow-up (in 3 months interval)|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).||Cell per microliter||Standard Deviation|Mean
683974|NCT01520922|Secondary|Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ Cell Counts up to 36 Months|CD5+ CD19+ cells were counted by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus. Baseline CD5+ CD19+ cell count value is the last pre-dose assessment values performed on cycle 1 Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline, 3-Month Follow-up to 36-Month Follow-up (in 3 months interval)|ATS Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).||Cell per microliter||Standard Deviation|Mean
684019|NCT01520727|Secondary|Time to Cmax (Tmax)||pre-dose then post-dose. Hour 0.25, 0.5, 0,75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 , 60 and 72 hours post dose|||hours||Full Range|Median
684020|NCT01520727|Secondary|Cmax - BIA 9-1067|Cmax - maximum plasma concentration|pre-dose then post-dose. Hour 0.25, 0.5, 0,75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 , 60 and 72 hours post dose|||ng/mL||Standard Deviation|Mean
684021|NCT01520727|Primary|Adverse Events (AEs)|Safety was evaluated from the number of reported adverse events (AEs)|7 weeks|||Number of Adverse Events|||Number
683975|NCT01520922|Secondary|Change From Baseline in the Immunoglobulin (Ig) Antibodies to End of Study Treatment|Immunoglobulins, or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Low levels indicate immuno-suppression. IgA, IgG, and IgM were measured in the blood samples of the participants. Baseline IgA, IgG, and IgM values are the last pre-dose assessment values performed on cycle 1 Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and end of study treatment (up to 30 months)|Safety Population. Only those participants who were available at the indicated time points were analyzed.||Gram per liter||Standard Deviation|Mean
683976|NCT01520922|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.|From first dose of study medication to 60 days after the last dose of study medication (if the event is considered as an AE), or up to 3 years after the last dose of study treatment or until the time of the next anti-CLL therapy, if considered a SAE|Safety Population: all participants who received at least one dose of any study treatment (ofatumumab or bendamustine).||Participants|||Number
683977|NCT01520922|Secondary|Time to Next Therapy|Time to next therapy is defined as the time from the date of the first administration of study treatment until the start of the next anti-CLL therapy.|From the start of study treatment until the start of the next anti-CLL therapy (up to 3 years after the last dose of study treatment)|ATS Population. Only participants that took anti-CLL therapy were evaluated.||Months||95% Confidence Interval|Median
683978|NCT01520922|Secondary|Investigator-Assessed Kaplan-Meier Estimates of Time to Progression|Time to progression is defined as the time from the date of the first administration of study treatment to disease progression (PD). PD requires at least one of the following: new lesion or increase by >=50% from Baseline in lymphocytes (LC) with at least 5000 B-lymphocytes per microliter (5.0 x 10^9/L), lymphadenopathy (Ly), size of liver and spleen, platelets (PL) >= 50% decrease from Baseline, or to <100,000/uL secondary to CLL, hemoglobin (Hb) decrease of >2 g/dL from Baseline or to <10 g/dL secondary to CLL, CLL- transformation, cytopenia after treatment. Response was determined according to the IWCLL updated NCI-WG guidelines 2008.|From the start of study treatment to disease progression (up to 3 years after the last dose of study treatment)|All treated subjects (ATS). This analysis includes patients who had progression.||Months||95% Confidence Interval|Median
683979|NCT01520922|Secondary|Investigator-assessed Kaplan-meier Estimates of Overall Survival|OS is defined as the interval of time between the date of the first administration of study treatment and the date of death due to any cause. For participants who did not die, time of death was censored at the date of last contact.|From the start of study treatment to the date of death due to any cause (up to 3 years after the last dose of study treatment)|All treated subjects. N= Death||Months||95% Confidence Interval|Median
683980|NCT01520922|Secondary|Investigator-assessed of Kaplan-meier Estimates of Progression-free Survival (PFS)|PFS is defined as the interval of time between the date of the first administration of study treatment and the earlier of the date of disease progression (PD) and the date of death due to any cause. PD requires at least one of the following:new lesion or increase by >=50% from BL in LC, Ly, size of liver and spleen, PL >= 50% decrease from BL, or to <100,000/uL secondary to CLL, Hb decrease of >2 g/dL from BL or to <10 g/dL secondary to CLL, CLL- transformation. Response was determined according to the IWCLL updated NCI-WG guidelines 2008. Participants who have neither progressed or died at the time of analysis were censored at the date of the last adequate assessment. If there was more than 1 scheduled visit missed, PFS is censored at the last adequate assessment of response. An adequate assessment is defined as an assessment where the investigator determined a response of CR, CRi, nPR, PR, or stable disease (SD).|From the start of study treatment until earliest date of disease progression or death (up to 3 years after the last dose of study treatment)|All Treated Subjects’ (ATS) population. N= Progression or Death||Months||95% Confidence Interval|Median
683981|NCT01520922|Secondary|Investigator-assessed Kaplan-meier Estimates of Duration of Response|The duration of response is defined as the time from the initial response (CR, CRi, nPR, or PR) to the first documented sign of disease progression (PD) or death due to any cause. PD requires at least one of the following: new lesion or increase by >=50% from Baseline in lymphocytes (LC) with at least 5000B-lymphocytes per microliter (5.0 x 10^9/L), lymphadenopathy (Ly), size of liver and spleen, platelets (PL) >= 50% decrease from Baseline, or to <100,000/uL secondary to CLL, hemoglobin (Hb) decrease of >2 g/dL from Baseline or to <10 g/dL secondary to CLL, CLL- transformation, cytopenia after treatment. Response was determined according to the IWCLL updated NCI-WG guidelines 2008.|From time of initial response (CR, CRi, nPR, or PR) to disease progression or death, whichever came first (up to 3 years after the last doseof study treatment)|ATS Population. Only participants with an initial response (CR, CRi, nPR, or PR) with PD or death were assessed for duration of response.||Months||95% Confidence Interval|Median
683982|NCT01520922|Secondary|Investigator-assessed Kaplan-meier Estimates of Time to Response|Time to response is defined as time from date of the first administration of study treatment to the first response (CR, CRi, nPR, or PR). Response was determined according to the IWCLL updated NCI-WG guidelines 2008. CR: all of the following criteria at least 2 months after last treatment: no lymphadenopathy (Ly)/ hepatomegaly/ splenomegaly/ constitutional symptoms; neutrophils >1500 per microliter (µL), platelets (PL) >100,000/µL, hemoglobin (Hb) >11.0 grams/deciliter (g/dL), lymphocytes (LC) <4000/µL, bone marrow (BM) sample must be normocellular for age, <30% LC, no lymphoid nodule. CRi: CR criteria, persistent anemia/ thrombocytopenia/ neutropenia unrelated to CLL but related to drug toxicity. nPR: persistent nodules BM. PR: >=50% decrease in LC, Ly, size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline (BL), Hb >11.0 g/dL or 50% improvement over BL, LC <4000/µL.|From the start of study treatment to the first response (CR, CRi, nPR, or PR) (up to 3 Month Follow-up (F/U) visit)|ATS Population. Only participants who had a response (CR, CRi, nPR, or PR) were evaluated.||Months||95% Confidence Interval|Median
684022|NCT01520714|Primary|Evidence of Change in Threshold of >1 Volt With Posture Changes||6 months|Early termination leading to small numbers of subjects; Non-efficacy of treatment leading to no data summary and analysis.|||||
683983|NCT01520922|Secondary|Number of Participants With Complete Response (CR) With and Without a CT Scan Assessment After the Last Dose of Study Treatment, as Assessed by the Investigator|Response was determined according to the IWCLL updated NCI-WG guidelines 2008. CR requires all of the following criteria at least 2 months after the last treatment: no lymphadenopathy (Ly)/ hepatomegaly/ splenomegaly/ constitutional symptoms; neutrophils >1500/µL, platelets (PL) >100,000/µL, hemoglobin (Hb) >11.0 g/dL, lymphocytes (LC) <4000/µL, bone marrow (BM) sample must be normocellular for age, <30% LC, no lymphoid nodule.|From the start of study treatment until 3 months after the last dose of study treatment|ATS Population||Participants|||Number
683984|NCT01520922|Secondary|Number of Participants With Overall Response (OR) With Computed Tomography (CT) Scan (CT Scan) Assessment, as Assessed by the Investigator|OR is defined as the number of participants achieving an objective response (complete response [CR], CR with incomplete bone marrow recovery [CRi], partial response [PR], and nodular PR [nPR]), after 3 cycles, after 6 cycles, and after the last dose of ofatumumab and bendamustine treatment. CR (all the criteria at least 2 months after last treatment): no lymphadenopathy (Ly)/ hepatomegaly/ splenomegaly/ constitutional symptoms; neutrophils >1500 per microliter (µL), platelets (PL) >100,000/µL, hemoglobin (Hb) >11 grams/deciliter (g/dL), lymphocytes (LC) <4000/µL, bone marrow (BM) sample must be normocellular for age, <30% LC, no lymphoid nodule. CRi: CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to CLL but related to drug toxicity. PR: >=50% decrease in LC, Ly, size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline (BL), Hb >11 g/dL or 50% improvement over BL, LC <4000/µL. nPR: persistent nodules BM.|From the start of study treatment until 3 months after the last dose of study treatment|ATS Population. OR was measured using the International Workshop for CLL (IWCLL) updated National Cancer Institute-sponsored Working Group (NCI-WG) guidelines 2008.||Participants|||Number
683985|NCT01520922|Primary|Number of Participants With Overall Response (OR), as Assessed by the Investigator|OR is defined as the number of participants achieving an objective response (complete response [CR], CR with incomplete bone marrow recovery [CRi], partial response [PR], and nodular PR [nPR]), after 3 cycles, after 6 cycles, and after the last dose of ofatumumab and bendamustine treatment. CR (all the criteria at least 2 months after last treatment): no lymphadenopathy (Ly)/ hepatomegaly/ splenomegaly/ constitutional symptoms; neutrophils >1500 per microliter (µL), platelets (PL) >100,000/µL, hemoglobin (Hb) >11 grams/deciliter (g/dL), lymphocytes (LC) <4000/µL, bone marrow (BM) sample must be normocellular for age, <30% LC, no lymphoid nodule. CRi: CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to CLL but related to drug toxicity. PR: >=50% decrease in LC, Ly, size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline (BL), Hb >11 g/dL or 50% improvement over BL, LC <4000/µL. nPR: persistent nodules BM.|From the start of study treatment until 3 months after the last dose of study treatment|As-treated subjects (ATS) Population: all participants who received at least one dose of both study drugs (ofatumumab and bendamustine). OR was measured using the International Workshop for CLL (IWCLL) updated National Cancer Institute-sponsored Working Group (NCI-WG) guidelines 2008. The 95% exact binomial confidence interval is for CR+CRi+nPR+PR.||Participants|||Number
683986|NCT01520909|Secondary|Population PK Model Point Estimate for Eltrombopag for Absorption Rate-constant (Ka)|Single PK samples were collected at each visit during Part 1 Weeks 2, 4, 6, 8, 10, 12 and at each weekly or monthly visit during Part 2 Weeks 1-12 (Study Weeks 13-37). The concentration data were pooled across visits to identify population PK and variability parameter estimates and covariate effects. Ka is defined as the absorption rate constant. This parameter is dose independent, and the population estimate Ka is reported.|Part 1 Weeks 2, 4, 6, 8, 10, 12, and Part 2 Weeks 1-12 (Study Weeks 13 - 37)|PK Population. Only those participants who provided pharmacokinetic samples were analyzed||1/h|||Number
683987|NCT01520909|Secondary|PK Assessments for Eltrombopag for Apparent Central Volume (Vc/F) and Apparent Peripheral Volume (Vp/F)|Single PK samples were collected at each visit during Part 1 Weeks 2, 4, 6, 8, 10, 12 and at each weekly or monthly visit during Part 2 Weeks 1-12 (Study Weeks 13-37). The concentration data were pooled across visits to identify population PK and variability parameter estimates and covariate effects. Vc/F is defined as the volume of the central (e.g. plasma) compartment and Vp/F is defined as the volume of the peripheral compartment. These parameters are dose independent. From the final model, a single value of each PK parameter was estimated for each subject, and geometric mean (95% CI) values are presented for each cohort.|Part 1 Weeks 2, 4, 6, 8, 10, 12, and Part 2 Weeks 1-12 (Study Weeks 13 - 37)|PK Population. Only those participants who provided pharmacokinetic samples were analyzed||Liters (L)||95% Confidence Interval|Geometric Mean
683988|NCT01520909|Secondary|Pharmacokinetic (PK) Assessments for Eltrombopag for Apparent Oral Clearance (CL/F) and Apparent Intercompartmental Clearance (Q/F)|Single PK samples were collected at each visit during Part 1 Weeks 2, 4, 6, 8, 10, 12 and at each weekly or monthly visit during Part 2 Weeks 1-12 (Study Weeks 13-37). The concentration data were pooled across visits to identify population PK and variability parameter estimates and covariate effects. CL/F is defined as the apparent oral clearance from plasma and Q/F is defined as apparent intercompartmental clearance. These parameters are dose independent. From the final model, a single value of each PK parameter was estimated for each subject, and geometric mean (95% CI) values are presented for each cohort.|Part 1 Weeks 2, 4, 6, 8, 10, 12, and Part 2 Weeks 1-12 (Study Weeks 13 - 37)|PK Population. Only those participants who provided pharmacokinetic samples were analyzed||Liters per hour (L/hr)||95% Confidence Interval|Geometric Mean
683989|NCT01520909|Secondary|Pharmacokinetic (PK) Assessments for Eltrombopag for Cmax|Single PK samples were collected at each visit during Part 1 Weeks 2, 4, 6, 8, 10, 12 and at each weekly or monthly visit during Part 2 Weeks 1-12 (Study Weeks 13-37). The concentration data were pooled across visits to identify population PK and variability parameter estimates and covariate effects. Cmax is defined as the maximum observed concentration. The Cmax for a 50mg dose was estimated for each cohort. From the final model, a single value of each PK parameter was estimated for each subject, and geometric mean (95% CI) values are presented for each cohort for a 50mg dose.|Part 1 Weeks 2, 4, 6, 8, 10, 12, and Part 2 Weeks 1-12 (Study Weeks 13 - 37)|PK Population. Only those participants who provided pharmacokinetic samples were analyzed||micrograms per milliliter (ug/mL)||95% Confidence Interval|Geometric Mean
684023|NCT01520558|Secondary|Efficacy|Determine relapse free survival (RFS) and overall survival (OS) following infusion with CNDO-109-Activated Allogeneic Natural Killer Cells.|from the date of documented CR until the first documented progression date or until day 360 post dose whichever is sooner||||||
683990|NCT01520909|Secondary|Pharmacokinetic (PK) Assessments for Eltrombopag for AUC (0-t)|Single PK samples were collected at each visit during Part 1 Weeks 2, 4, 6, 8, 10, 12 and at each weekly or monthly visit during Part 2 Weeks 1-12 (Study Weeks 13-37). The concentration data were pooled across visits to identify population PK and variability parameter estimates and covariate effects. AUC(0-t) is defined as the area under the concentration-time curve over the dosing interval. The AUC(0-t) for a 50mg dose was estimated for each cohort. From the final model, a single value of each PK parameter was estimated for each subject, and geometric mean (95% CI) values are presented for each cohort for a 50mg dose.|Part 1 Weeks 2, 4, 6, 8, 10, 12, and Part 2 Weeks 1-12 (Study Weeks 13 - 37)|PK Population. Only those participants who provided pharmacokinetic samples were analyzed||micrograms*hour per milliliter (ug.h/mL)||95% Confidence Interval|Geometric Mean
683991|NCT01520909|Secondary|Number of Participants With Worsening Visual Acuity Due to Cataracts at Follow-Up Week 24|"The visual acuity assessment was performed by an ophthalmologist or an optometrist under the guidance of an ophthalmologist. Visual acuity is defined as acuteness or clearness of vision. The number of participants with worsening visual acuity due to cataracts at Follow-up Week 24 are presented. Change due to cataracts is categorized as Yes or No."|Baseline and Follow-Up Week 24 (Week 61)|Safety Population. Only those participants who had worsening visual acuity at Week 61 were analyzed.||Participants|||Number
683992|NCT01520909|Secondary|Number of Participants With Worsening Visual Acuity Due to Cataracts at Week 24 of Part 2|"The visual acuity assessment was performed by an ophthalmologist or an optometrist under the guidance of an ophthalmologist. Visual acuity is defined as acuteness or clearness of vision. The number of participants with worsening visual acuity due to cataracts at Week 24 of Part 2 are presented. Change due to cataracts is categorized as Yes or No."|Baseline and Week 24 of Part 2|Safety Population. Only those participants who had worsening visual acuity at Week 24 were analyzed.||Participants|||Number
683993|NCT01520909|Secondary|Number of Participants With Worsening Visual Acuity Due to Cataracts at Week 12 of Part 1|"The visual acuity assessment was performed by an ophthalmologist or an optometrist under the guidance of an ophthalmologist. Visual acuity is defined as acuteness or clearness of vision. The number of participants with worsening visual acuity due to cataracts at Week 12 of Part 1 are presented. Change due to cataracts is categorized as Yes or No."|Baseline and Week 12 of Part 1|Safety Population. Only those participants who had a result of ‘worsening’ in assessment of change of visual acuity at this timepoint were analyzed.||Participants|||Number
683994|NCT01520909|Secondary|Number of Participants With a Change in Visual Acuity Since Baseline at Follow-Up Week 24|The visual acuity assessment was performed by an ophthalmologist or an optometrist under the guidance of an ophthalmologist. Visual acuity is defined as acuteness or clearness of vision. Change in visual acuity results are presented as No Change, NCS, Improvement, and Worsening since Baseline. The Baseline value was obtained at the Screening Visit.|Baseline and Follow-Up Week 24 (Study Week 61)|Safety Population. Only those participants who entered into Part 2 (Open-label eltrombopag-only phase) were analyzed.||Participants|||Number
683995|NCT01520909|Secondary|Number of Participants With a Change in Visual Acuity Since Baseline at Week 24 of Part 2|The visual acuity assessment was performed by an ophthalmologist or an optometrist under the guidance of an ophthalmologist. Visual acuity is defined as acuteness or clearness of vision. Change in visual acuity results are presented as No Change, NCS, Improvement, and Worsening since Baseline. The Baseline value was obtained at the Screening Visit.|Baseline and Week 24 of Part 2|Safety Population. Only those participants who entered into Part 2 (Open-label eltrombopag-only phase) were analyzed.||Participants|||Number
683996|NCT01520909|Secondary|Number of Participants With a Change in Visual Acuity Since Baseline at Week 12 of Part 1|The visual acuity assessment was performed by an ophthalmologist or an optometrist under the guidance of an ophthalmologist. Visual acuity is defined as acuteness or clearness of vision. Change in visual acuity results are presented as No (no change from Baseline), Not Clinically Significant (NCS), Improvement, and Worsening since Baseline. The Baseline value was obtained at the Screening Visit.|Baseline and Week 12 of Part 1|Safety Population||Participants|||Number
683997|NCT01520909|Secondary|Number of Participants With Vital Sign Data Falling Outside the Reference Ranges (RR) at the Indicated Visit During Part 2|Vital sign measurements were taken before any blood draw and included systolic blood pressure (SBP), diastolic blood pressure (DBP), and heart rate(HR). The number of participants are reported with vital sign data falling outside the standard RR as reference range high(RRH) and reference range low(RRL) from SCR up to Week 24 of Part 2 and from Follow-up Week 1 to Week 4. RR for Blood Pressure(mmHg) are read as: Lower Limit of Normal, Normal Range, Upper Limit of Normal. For Ages 1 to 5 years (yrs) ranges are SBP <85, 85 to 115, >115; DBP <45, 45 to70, >70. Ages 6 to 11 yrs: SBP <85, 85 to 120, >120; DBP <50, 50 to 75, >75. Ages 12 to 17 yrs: SBP <95, 95 to 135, >135; DBP <55, 55 to 85, >85. RR for HR (bpm) are ages 1 to < 3 yrs: <90, 90 to 140, >140; ages 3 to < 5 yrs: <75, 75 to 130, >130, ages 5 to < 8yrs: <65, 65 to 115, >115; ages 8 to < 12yrs: <55, 55 to 110, >110; and ages 12 to 18 yrs: <55, 55 to 110, >110.|From Week 1 up to Week 24 of Part 2 and Follow-up Week 1 to Week 4 (up to Week 41)|Safety Population. Only those participants who entered into Part 2 (Open-label eltrombopag-only phase) were analyzed. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).||Participants|||Number
683998|NCT01520909|Secondary|Number of Participants With Vital Sign Data Falling Outside the Reference Ranges (RR) at the Indicated Visit During Part 1|Vital sign measurements were taken before any blood draws and included systolic blood pressure(SBP), diastolic blood pressure(DBP), and heart rate(HR). The number of participants are reported with vital sign data falling outside the standard reference ranges RR as reference range high(RRH) and reference range low(RRL). The Baseline(BL) value is defined as the value taken at Day 1 or if missing, the latest non-missing SCR value. RR for Blood Pressure (mmHg) are read as: Lower Limit of Normal, Normal Range, Upper Limit of Normal. For Ages 1 to 5 years (yrs) ranges are SBP <85, 85 to 115, >115; DBP <45, 45 to70, >70. Ages 6 to 11 yrs: SBP <85, 85 to 120, >120;, DBP <50, 50 to 75, >75. Ages 12 to 17 yrs: SBP <95, 95 to 135, >135; DBP <55, 55 to 85, >85. RR for HR(bpm) are ages 1 to < 3 yrs: <90, 90 to 140, >140; ages 3 to < 5 yrs: <75, 75 to 130, >130, ages 5 to < 8yrs: <65, 65 to 115, >115; ages 8 to < 12yrs: <55, 55 to 110, >110; and ages 12 to 18 yrs: <55, 55 to 110, >110.|From Screening (SCR) up to Week 13 of Part 1|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles).||Participants|||Number
683999|NCT01520909|Secondary|Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During Part 2|Hematology parameters were summarized according to the NCI CTCAE, version 4.0: G0, none, G1, mild; G2, moderate; G3, severe; G4, life-threatening or disabling. Hematology parameters included: leukocytes, neutrophils, hemoglobin (increased), hemoglobin (anemia), lymphocytes (increased), and lymphocytes (decreased). For participants randomized to Placebo in Part 1, the BL value for Part 2 is defined as the value taken at Week 13 of Part 1. For participants randomized to Eltrombopag in Part 1, the BL value is defined as the value taken on Day 1 or, if missing, the latest non-missing Screening value. For participants who do not have both a Screening and Day 1 value, the Screening or Day 1 value will be used as BL. The maximum post-BL toxicity grade includes any scheduled or unscheduled post-BL assessment.|From Baseline up to Week 24 of Part 2 and Follow-up Weeks 1 to 4 (up to Study Week 41)|Safety Population. Only those participants who entered into Part 2 (Open-label eltrombopag-only phase) were analyzed.||Participants|||Number
684000|NCT01520909|Secondary|Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During Part 1|Hematology parameters were summarized according to the NCI CTCAE, version 4.0: G0, none; G1, mild; G2, moderate; G3, severe; G4, life-threatening or disabling. Hematology parameters included: leukocytes, neutrophils, hemoglobin (increased), hemoglobin (anemia), lymphocytes (increased), and lymphocytes (decreased). The Baseline value is defined as the value taken at Day 1 or, if missing, the latest non-missing Screening value. The maximum post-Baseline toxicity grade includes any scheduled or unscheduled post-Baseline assessment during Part 1.|From Baseline up to Week 13 of Part 1|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles).||Participants|||Number
684001|NCT01520909|Secondary|Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During Part 2|Clinical chemistry parameters were summarized according to the NCI CTCAE, version 4.0: G0, none; G1, mild; G2, moderate; G3, severe; G4, life-threatening or disabling. Clinical chemistry parameters included: AST, ALP, total bilirubin, albumin, ALT, and creatinine. For participants randomized to Placebo in Part 1, the BL value for Part 2 is defined as the value taken at Week 13 of Part 1. For serum creatinine, the value taken at Week 13 of Part 1 will be used as BL. For participants randomized to Eltrombopag in Part 1, the BL value is defined as the value taken on Day 1 or, if missing, the latest non-missing Screening value. For serum creatinine, due to the variations in creatinine, the average of the Screening and the Day 1 values will be used as BL. For participants who do not have both a Screening and Day 1 value, the Screening or Day 1 value will be used as BL. The maximum post-BL toxicity grade includes any scheduled or unscheduled post-BL assessment.|From Baseline (BL) of Part 2 through Follow-up|Safety Population. Only those participants who entered into Part 2 (Open-label eltrombopag-only phase) were analyzed.||Participants|||Number
684002|NCT01520909|Secondary|Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During Part 1|Clinical chemistry parameters were summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0: Grade 0 (G0), none; Grade 1 (G1), mild; Grade 2 (G2), moderate; Grade 3 (G3), severe; Grade 4 (G4), life-threatening or disabling. Clinical chemistry parameters included: aspartate amino transferase (AST), alkaline phosphatase (ALP), total bilirubin, albumin, alanine amino transferase (ALT), prothrombin international normalized ratio (PT INR), activated partial thromboplastin time (APTT), and creatinine. The Baseline value is defined as the value taken at Day 1 or, if missing, the latest non-missing Screening value. For serum creatinine, due to the variations in creatinine, the average of the Screening and the Day 1 values will be used as Baseline. The maximum post-Baseline toxicity grade includes any scheduled or unscheduled post-Baseline assessment during Part 1.|From Baseline up to Week 13 of Part 1|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles).||Participants|||Number
684003|NCT01520909|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During Part 2|An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death, is life threatening; requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect. Medical or scientific judgment should be exercised in other situations.|From Day 1 of Part 2 up to Week 24 of Part 2 + 1 day|Safety Population||Participants|||Number
684004|NCT01520909|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During Part 1|An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect. Medical or scientific judgment should be exercised in other situations.|From Day 1 of Treatment up to Week 13 of Part 1+ 1 day|Safety Population: all participants who received at least one dose of the investigational product||Participants|||Number
684005|NCT01520909|Secondary|Number of Participants With Any Bleeding and Significant Bleeding as Assessed Using the WHO Bleeding Scale During Part 2|The WHO Bleeding Scale is a measure of bleeding severity with the following grades: Grade 0 = no bleeding, Grade 1 = petechiae, Grade 2 = mild blood loss, Grade 3 = gross bleeding and Grade 4 = debilitating blood loss. The WHO Grades were dichotomized into the following categories: no bleeding = Grade 0; any bleeding = Grade 1 to 4; no clinically significant bleeding = Grade 0 to 1; clinically significant bleeding = Grade 2 to 4.|From Baseline of Part 2 through Follow-up|ITT Population. Only those participants who entered into Part 2 open-label Eltrombopag only phase were analyzed. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).||Participants|||Number
684006|NCT01520909|Secondary|Number of Participants Who Required a Protocol-defined Rescue Treatment During Part 2|Rescue treatment was defined as either a new immune (idiopathic) thrombocytopenic purpura (ITP) medication, an increase in the dose of a concomitant ITP medication from Baseline, a platelet transfusion, or a splenectomy.|From Baseline up to Week 24 of Part 2|ITT Population. Only those participants who entered into Part 2 (Open-label eltrombopag-only phase) were analyzed.||Participants|||Number
684007|NCT01520909|Secondary|Number of Participants Who Reduced or Discontinued Baseline Concomitant ITP Medications During Part 2 Without Requiring Subsequent Rescue Therapy|Participants who discontinued or had a sustained reduction of a baseline immune (idiopathic) thrombocytopenic purpura (ITP) medication during the 24 weeks of Part 2 (Open-Label Period) and without requiring subsequent rescue therapy. For participants randomized to placebo in Part 1, Baseline is defined as Week 13 of Part 1. For participants randomized to eltrombopag in Part 1, Baseline is defined as Day 1 of Part 1. A sustained reduction was defined as a reduction for 4 weeks or more.|From Baseline up to Week 24 of Part 2|ITT Population. Only those participants who entered into Part 2 (Open-label eltrombopag-only phase) and taking an ITP medication at Baseline were analyzed.||Participants|||Number
684008|NCT01520909|Secondary|Maximum Duration for Which a Participant Continuously Maintained a Platelet Count of >=50 Gi/L During Part 2|The maximum duration for which a participant continuously maintained a platelet count of >=50 Gi/L was calculated and summarized for the 24 weeks of eltrombopag dosing (Part 2). Participants with non-weekly assessments were assumed to have maintained a positive response for each week between two assessments that had positive responses. If the participant achieved a positive response at an assessment and then achieved a negative response at the next assessment, then it was assumed that the participant had achieved a positive response for one day.|From Baseline up to Week 24 of Part 2|ITT Population. Only those participants who entered into Part 2 (Open-label eltrombopag-only phase) were analyzed.||Weeks||Standard Deviation|Mean
684009|NCT01520909|Secondary|Number of Weeks in Which Participants Achieved a Platelet Count >=50 Gi/L, Between Weeks 4 and 24 of Part 2|Platelet response was analyzed after Week 4 for the eltrombopag-only period to allow participants who had been randomized to placebo in the Randomized Period time to escalate to their optimal dose of eltrombopag. Participants with non-weekly assessments were assumed to have maintained a positive response for each week between two assessments that had positive responses. If the participant achieved a positive response at an assessment and then achieved a negative response at the next assessment, then it was assumed that the participant had achieved a positive response for one day.|From Week 4 up to Week 24 of Part 2|ITT Population. Only those participants who entered into Part 2 (Open-label eltrombopag-only phase) were analyzed.||Weeks||Standard Deviation|Mean
684010|NCT01520909|Secondary|Number of Participants Who Achieved a Platelet Count >=50 Gi/L at Any Time During Part 2|Participants who achieved a platelet count >=50 Gi/L at any time during Part 2 (up to Week 24) were reported.|From Baseline up to Week 24 of Part 2|ITT Population. Only those participants who entered into Part 2 (Open-label eltrombopag-only phase) were analyzed.||Participants|||Number
684011|NCT01520909|Secondary|Number of Participants With Any Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 1|The WHO Bleeding Scale is a measure of bleeding severity with the following grades: Grade 0=no bleeding; Grade 1=petechiae; Grade 2=mild blood loss; Grade 3=gross bleeding; Grade 4=debilitating blood loss. The WHO grades were dichotomized into the following categories: no bleeding=Grade 0; any bleeding=Grades 1 to 4; no clinically significant bleeding=Grades 0 to 1; clinically significant bleeding=Grades 2 to 4. Baseline was defined as the Day 1 assessment or the latest possible screening assessment.|From Baseline through Follow-up of Part 1|ITT Population. Only those participants that did not enroll in Part 2 were analyzed during the follow-up visits. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles).||Participants|||Number
684012|NCT01520909|Secondary|Number of Participants Who Required a Protocol-defined Rescue Treatment During Part 1|Rescue treatment is defined as either a new immune (idiopathic) thrombocytopenic purpura (ITP) medication, an increase in the dose of a concomitant ITP medication from Baseline, a platelet transfusion, or a splenectomy.|From Baseline up to Week 12 of Part 1|ITT Population||Participants|||Number
684013|NCT01520909|Secondary|Maximum Duration for Which a Participant Continuously Maintained a Platelet Count of >=50 Gi/L During the First 12 Weeks of Part 1|The maximum duration for which a participant continuously maintained a platelet count >=50 Gi/L was calculated and summarized for the first 12 weeks of Part 1. Participants with non-weekly assessments were assumed to have maintained a positive response for each week between two assessments that had positive responses. If a participant achieved a positive response at an assessment and then achieved a negative response at the next assessment, then it was assumed that the participant had achieved a positive response for one day.|From Baseline up to Week 12 of Part 1|ITT Population||Weeks||Standard Deviation|Mean
684014|NCT01520909|Secondary|Weighted Mean Platelet Count|"The weighted mean platelet count is defined as the area under the platelet-time curve divided by the duration of the study (12 weeks). Weighted mean platelet counts from baseline to week 12 of the randomized period was compared between placebo and eltrombopag using an analysis of covariance model (ANCOVA) adjusting for baseline platelet count and age cohort. For each subject the area between two adjacent visits with platelet counts was calculated. The area was calculated for all pairs of adjacent visits starting at Day 1 of randomized period and then the total sum of all the areas was divided by the total duration of time during the randomized period. For each subject, this method calculates an ‘average’ platelet count and it allows the possibility that subjects may have had different number of assessments during different times relative to baseline."|Baseline and Week 12 of Part 1|ITT Population. Only those participants with a value at Baseline and post-Baseline were analyzed.||Gi/L||Standard Deviation|Mean
684015|NCT01520909|Secondary|Number of Participants Achieving a Platelet Count >=50 Gi/L at Any Time During the First 6 Weeks of Part 1|Participants who achieved a platelet count >=50 Gi/L at any time during the first 6 weeks of Part 1 were reported.|From Baseline up to Week 6 of Part 1|ITT Population||Participants|||Number
684016|NCT01520909|Secondary|Number of Participants Achieving a Platelet Count >=50 Gi/L at Any Time During the First 12 Weeks of Part 1|Participants who achieved a platelet count >=50 Gi/L at any time during the first 12 weeks of Part 1 were reported.|From Baseline up to Week 12 of Part 1|ITT Population||Participants|||Number
684017|NCT01520909|Secondary|Percentage of Responders|Percentage of participants who responded (defined as platelet count >= 50 Gi/L in absence of rescue) at least once up to week 12 of Part 1 (Odds of achieving a platelet count >=50 Gi/L during the first 12 weeks of Part 1)|From Week 1 up to Week 12 of Part 1|ITT Population||Percentage of participants|||Number
684024|NCT01520558|Secondary|Additional Safety Profile Beyond MTD|Characterize the safety profile of CNDO-109-Activated Allogeneic Natural Killer Cells infusion after preparative therapy by measurement of adverse events, safety labs, vital signs, bone marrow biopsy/aspiration and physical examination.|up to 360 days post dose||||||
684025|NCT01520558|Primary|Define MTD|The primary objective is to define the maximum tolerated dose (MTD), or the maximum tested dose where multiple dose-limiting toxicities (DLTs) are not observed, of CNDO-109-Activated Allogeneic Natural Killer Cells infused after preparative chemotherapy, administered to patients with acute myeloid leukemia (AML) who are in their first complete remission (CR1) at the time of enrollment and are considered to be at high risk for recurrence. The MTD outcome measure is presented as number of participants with DLTs.|up to 30 days post dose|||Participants|||Count of Participants
684026|NCT01520532|Secondary|Acute Efficacy, as Determined by Complete Pulmonary Vein Isolation (PVI) Per Subject.|The number of subjects with pulmonary vein isolation (PVI) at the end of ablation procedure. This will characterize if use of best practices during PVAC ablation negatively affects acute efficacy.|Day 1 (End of Procedure)|All subjects who underwent ablation and post-procedure MRI.||participants|||Number
684027|NCT01520532|Secondary|Acute Safety Events|Assess the number of procedure or device-related serious adverse events when applying best practices with PVAC.|30 days|All subjects who underwent an ablation and post-procedure MRI||events|||Number
684028|NCT01520532|Primary|New Asymptomatic Cerebral Embolic Lesions, Visualized as 'Bright Spots' on Post-ablation MRI.|An acute embolic lesion is defined as a focal hyper-intense area detected on the diffusion-weighted (DW) sequence, corresponding to a hyper-intense signal intensity in the fluid-attenuated inversion recovery (FLAIR) sequence, and also confirmed by apparent diffusion coefficient (ADC) mapping to rule out a shine-through artifact.|Within 1-3 days post ablation|All subject who underwent an ablation and post-procedure MRI.||participants|||Number
684029|NCT01520506|Secondary|Renal Denervation Procedure Effectiveness|Procedural Effectiveness, defined as rate of Office Systolic Blood Pressure (SBP) reduction > 10 mmHg at 6 months compared to baseline|From baseline to 6 months|||percentage of participants|||Number
684030|NCT01520506|Secondary|Chronic Procedural Safety|Chronic Procedural Safety, defined as the overall rate of Serious Adverse Events and Adverse Device Effects at 6 months|6 months|||percentage of participants|||Number
684031|NCT01520506|Primary|Acute Procedural Safety|"Acute Procedural Safety, defined as the overall rate of Serious Adverse Events (SAE's) and adverse device effects at discharge:
SAE's related to groin and vascular access complications, and
SAE's related to renal artery injury."|One Week|||percentage of participants|||Number
684032|NCT01520454|Secondary|Phosphorylation of STAT3 Pathways Downstream of Leptin After Lipid Administration|"Intracellular signaling mechanisms downstream of leptin (particularly the STAT3 pathway) in response to lipid administration as represented by phosphorylation (pSTAT3).
The analysis unfortunately can not be performed due to technical reasons."|Baseline to 6 hours||||||
684033|NCT01520454|Secondary|Change in Circulating Adiponectin Levels|The Adiponectin AUC was calculated from baseline to six hours|Baseline to 6 hours|Areas Under the Curve are presented||ng*min/ml||Standard Deviation|Mean
684034|NCT01520454|Secondary|Change in Circulating Leptin Levels|The Leptin AUC was calculated from baseline to six hours|Baseline to 6 hours|Areas Under the Curve are presented||ng*min/ml||Standard Deviation|Mean
684035|NCT01520454|Secondary|Change in Circulating Insulin Levels|The Insulin AUC was calculated from baseline to six hours|Baseline to 6 hours|Areas Under the Curve are presented||mU*min/ml||Standard Deviation|Mean
684036|NCT01520454|Secondary|Change in Circulating Glucose Levels|The Glucose AUC was calculated from baseline to six hours|Baseline to 6 hours|Areas Under the Curve are presented||mg*min/dl||Standard Deviation|Mean
684037|NCT01520454|Primary|Change in Circulating Peptide Tyrosine Tyrosine (PYY) Levels|The PYY AUC was calculated from baseline to six hours|Baseline to 6 hours|Areas under the curve are presented||pg*min/ml||Standard Deviation|Mean
684038|NCT01520454|Primary|Change in Circulating Ghrelin Levels|The Ghrelin AUC was calculated from baseline to six hours|Baseline to 6 hours|Areas under the curve are presented||pg*min/ml||Standard Deviation|Mean
684039|NCT01520454|Primary|Change in Circulating Gastric Inhibitory Polypeptide (GIP) Levels|The GIP AUC fwas calculated from baseline to six hours|Baseline to 6 hours|Areas under the curve are presented||pM*min/ml||Standard Deviation|Mean
684040|NCT01520454|Primary|Change in Circulating Glucagon-like Peptide-1 (GLP-1) Levels|The GLP-1 area under the curve (AUC) was calculated from baseline to six hours|Baseline to 6 hours|Areas under the curve are presented||pM*min||Standard Deviation|Mean
684041|NCT01520402|Primary|Median Cumulative Warfarin Dose Requirement by Genotype Category (CYP2C9 and VKORC1 -1639 G>A Combination)|Subjects were also grouped into four categories based on CYP2C9 and VKORC1 genotype profile: Group 1 (CYP2C9 wild-type and VKORC1 wild-type), Group 2 (CYP2C9 wild-type and VKORC1 variant), Group 3 (CYP2C9 variant and VKORC1 wild-type), and Group 4 (CYP2C9 variant and VKORC1 variant). Median cumulative warfarin dose requirement was determined for each genotype category.|2-30 days|Of the 35 subjects enrolled, 30 were included in the study as above.||milligrams||Inter-Quartile Range|Median
684042|NCT01520402|Secondary|Explained Variation in Combined Therapeutic Warfarin Dose Models|The proportion of variance (R^2) explained by each predictor was calculated using multivariate regression analysis and adjusted for age, gender and reported race, with outcome values logarithmically transformed. The study was powered to detect R^2 > 20%, and significance was accepted at p<0.05.|average of 2 - 30 days|Of the 35 subjects enrolled, 30 completed the study as described above.||proportion of variance|||Number
684043|NCT01520402|Secondary|Median Cumulative Warfarin Dose Requirements by CYP4F2 Genotype Status|To assess the effect of CYP4F2 genotype variants on the anticoagulant response to warfarin.|average of 2 - 30 days|Of 35 subjects were enrolled, 30 were included as listed above.||milligrams||Inter-Quartile Range|Median
684044|NCT01520402|Primary|Median Cumulative Therapeutic Warfarin Dose (Milligrams)Requirements by Genotype|To assess the effect of genotype variants (CYP2C9 and VKORC1 -1639 G>A) on the anticoagulant response to warfarin, the primary outcome was the cumulative dose required to achieve an INR value in the usual clinical therapeutic range (>2.0) for two consecutive days.|average of 2 - 13 days|Of the 35 subjects enrolled, 30 were included in the study as listed above.||milligrams||Inter-Quartile Range|Median
684045|NCT01519960|Secondary|Change From Baseline in Quantitative HBsAg Level in Group C|The change in quantitative HBsAg from Baseline to each visit was averaged among all participants and expressed in log10 IU/mL.|Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)|Safety Population.||log10 IU/mL||Standard Deviation|Mean
684046|NCT01519960|Secondary|Quantitative HBsAg Level in Group C|Quantitative HBsAg at each visit was averaged among all participants and expressed in log10 IU/mL.|Baseline; Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)|Safety Population.||log10 IU/mL||Standard Deviation|Mean
684047|NCT01519960|Secondary|Change From Baseline in Quantitative HBeAg Level in Group C|The change in quantitative HBeAg from Baseline to each visit was averaged among all participants and expressed in log10 PEIU/mL.|Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)|"Safety Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table."||log10 PEIU/mL||Standard Deviation|Mean
684048|NCT01519960|Secondary|Quantitative HBeAg Level in Group C|Quantitative HBeAg at each visit was averaged among all participants and expressed in log10 PEIU/mL.|Baseline; Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)|Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.||log10 PEIU/mL||Standard Deviation|Mean
684049|NCT01519960|Secondary|Change From Baseline in Quantitative Serum ALT Level in Group C|The change in quantitative ALT from Baseline to each visit was averaged among all participants and expressed as a factor of the laboratory-specific ULN (for example, 1 × ULN, 2 × ULN, 3 × ULN).|Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)|Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.||factor of ULN||Standard Deviation|Mean
684050|NCT01519960|Secondary|Change From Baseline in Quantitative HBsAg Level in Groups A and B|The change in quantitative HBsAg from Baseline to each visit was averaged among all participants and expressed in log10 IU/mL.|Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table."||log10 IU/mL||Standard Deviation|Mean
684051|NCT01519960|Secondary|Quantitative HBsAg Level in Groups A and B|Quantitative HBsAg at each visit was averaged among all participants and expressed in log10 IU/mL.|Baseline; Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)|ITT Population. All participants were included in the endpoint analysis. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.||log10 IU/mL||Standard Deviation|Mean
684052|NCT01519960|Secondary|Change From Baseline in Quantitative HBeAg Level in Groups A and B|The change in quantitative HBeAg from Baseline to each visit was averaged among all participants and expressed in log10 PEIU/mL.|Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table."||log10 PEIU/mL||Standard Deviation|Mean
684053|NCT01519960|Secondary|Quantitative HBeAg Level in Groups A and B|Quantitative HBeAg at each visit was averaged among all participants and expressed in log10 Paul Ehrlich Institute units per milliliter (PEIU/mL).|Baseline; Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)|ITT Population. All participants were included in the endpoint analysis. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.||log10 PEIU/mL||Standard Deviation|Mean
684054|NCT01519960|Secondary|Change From Baseline in Quantitative Serum ALT Level in Groups A and B|The change in quantitative ALT from Baseline to each visit was averaged among all participants and expressed as a factor of the laboratory-specific ULN (for example, 1 × ULN, 2 × ULN, 3 × ULN).|Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)|ITT Population. All participants were included in the endpoint analysis. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.||factor of ULN||Standard Deviation|Mean
684055|NCT01519960|Secondary|Percentage of Participants With HBeAg Seroconversion at 24 Weeks After EOT in Group C|HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. The percentage of participants with HBeAg seroconversion at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|Safety Population.||percentage of participants||95% Confidence Interval|Number
684056|NCT01519960|Secondary|Change From Baseline in Weight for Age Z-Score in Group C|The difference between the population mean and raw scores was calculated as the weight for age z-score. Mean absolute values at Baseline were reported. The change from Baseline to each visit was averaged among all participants and expressed in units of standard deviations.|Baseline; Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)|Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.||standard deviations||Standard Deviation|Mean
684057|NCT01519960|Secondary|Change From Baseline in Height for Age Z-Score in Group C|The difference between the population mean and raw scores was calculated as the height for age z-score. Mean absolute values at Baseline were reported. The change from Baseline to each visit was averaged among all participants and expressed in units of standard deviations.|Baseline; Weeks 12, 24, 36, 48; FU Weeks 12, 24 (up to 72 weeks overall)|Safety Population.||standard deviations||Standard Deviation|Mean
684058|NCT01519960|Secondary|Change From Baseline in Weight for Age Z-Score in Groups A and B|The difference between the population mean and raw scores was calculated as the weight for age z-score. Mean absolute values at Baseline were reported. The change from Baseline to each visit was averaged among all participants and expressed in units of standard deviations.|Baseline; Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)|"Safety Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table."||standard deviations||Standard Deviation|Mean
684059|NCT01519960|Secondary|Change From Baseline in Height for Age Z-Score in Groups A and B|The difference between the population mean and raw scores was calculated as the height for age z-score. Mean absolute values at Baseline were reported. The change from Baseline to each visit was averaged among all participants and expressed in units of standard deviations.|Baseline; Weeks 12, 24, 36, 48; FU Weeks 12, 24 (up to 72 weeks overall)|"Safety Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table."||standard deviations||Standard Deviation|Mean
684062|NCT01519960|Secondary|Percentage of Participants With >15% Drop in Weight Percentile for Age in Groups A and B|The percentage of participants with >15% drop in weight percentile for age from Baseline to each visit was reported.|Weeks 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)|"Safety Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table."||percentage of participants|||Number
684063|NCT01519960|Secondary|Percentage of Participants With >15% Drop in Height Percentile for Age in Groups A and B|The percentage of participants with >15% drop in height percentile for age from Baseline to each visit was reported.|Weeks 12, 24, 36, 48; FU Weeks 12, 24 (up to 72 weeks overall)|"Safety Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table."||percentage of participants|||Number
684064|NCT01519960|Secondary|Estimated Area Under the Concentration-Time Curve (AUC) by BSA Category|AUC was estimated using population pharmacokinetic (PK) modeling. The AUC at steady-state was averaged among participants who received PEG-IFN and reported by BSA category. Categories of BSA-based dosing used in the analysis were as follows: 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg. The estimated AUC was expressed in hours by nanograms per milliliter (h*ng/mL).|Pre-dose (0 hours) at Baseline and Weeks 4, 8, 12, 24; post-dose (24-48, 72-96, 168 hours) during Weeks 1, 24 (up to 24 weeks overall)|"PK Substudy Population: All participants who consented to participate in the PK substudy. The Number of Participants Analyzed reflects the total combined number of participants who provided evaluable data across all BSA categories. The number of participants who provided evaluable data within each BSA category (n) is shown in the table."||h*ng/mL||Full Range|Mean
684065|NCT01519960|Secondary|Change From Baseline in Liver Stiffness Measure (LSM) in Groups A, B, C|Liver elastography was performed to assess elasticity and extent of hepatic fibrosis. The change in LSM from Baseline to each visit was averaged among all participants in expressed in kilopascals (kPa). Positive changes in LSM values corresponded to an increase in stiffness and hepatic fibrosis.|Baseline; Week 48; FU Week 24 (up to 72 weeks overall)|"Liver Substudy Population: All participants who consented to participate in the liver elasticity substudy. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table."||kPa||Standard Deviation|Mean
684066|NCT01519960|Secondary|Change From Baseline in Quantitative HBV DNA Level in Group C|The change in quantitative HBV DNA from Baseline to each visit was averaged among all participants and expressed in log10 IU/mL.|Weeks 12, 24, 36, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)|Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.||log10 IU/mL||Standard Deviation|Mean
684067|NCT01519960|Secondary|Quantitative HBV DNA Level in Group C|Quantitative HBV DNA at each visit was averaged among all participants and expressed in log10 IU/mL.|Baseline; Weeks 12, 24, 36, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)|Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.||log10 IU/mL||Standard Deviation|Mean
684068|NCT01519960|Secondary|Quantitative Serum ALT Level in Group C|Quantitative ALT at each visit was averaged among all participants and expressed as a factor of the laboratory-specific ULN (for example, 1 × ULN, 2 × ULN, 3 × ULN).|Baseline; Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)|Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.||factor of ULN||Standard Deviation|Mean
684069|NCT01519960|Secondary|Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at EOT in Group C|HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <2,000 IU/mL at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|Safety Population.||percentage of participants||95% Confidence Interval|Number
684070|NCT01519960|Secondary|Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at EOT in Group C|HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <20,000 IU/mL at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|Safety Population.||percentage of participants||95% Confidence Interval|Number
684071|NCT01519960|Secondary|Percentage of Participants With HBV DNA Undetectable at EOT in Group C|HBV DNA was quantified using PCR by Roche Taqman. Undetectable HBV DNA was defined as HBV DNA <29 IU/mL. The percentage of participants with HBV DNA undetectable at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|Safety Population.||percentage of participants||95% Confidence Interval|Number
684072|NCT01519960|Secondary|Percentage of Participants With HBV DNA <2,000 IU/mL at EOT in Group C|HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA <2,000 IU/mL at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|Safety Population.||percentage of participants||95% Confidence Interval|Number
684073|NCT01519960|Secondary|Percentage of Participants With HBV DNA <20,000 IU/mL at EOT in Group C|HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA <20,000 IU/mL at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|Safety Population.||percentage of participants||95% Confidence Interval|Number
684074|NCT01519960|Secondary|Percentage of Participants With Normal ALT at EOT in Group C|Normal ALT was defined as ALT ≤ ULN, where each ULN was given by the laboratory at which the sample was analyzed. The percentage of participants with normal ALT at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|Safety Population.||percentage of participants||95% Confidence Interval|Number
684075|NCT01519960|Secondary|Percentage of Participants With Loss of HBsAg at EOT in Group C|The percentage of participants with loss of HBsAg at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|Safety Population.||percentage of participants||95% Confidence Interval|Number
684078|NCT01519960|Secondary|Percentage of Participants With HBeAg Seroconversion at EOT in Group C|HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. The percentage of participants with HBeAg seroconversion at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|Safety Population.||percentage of participants||95% Confidence Interval|Number
684079|NCT01519960|Secondary|Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at 24 Weeks After EOT in Group C|HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <2,000 IU/mL at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|Safety Population.||percentage of participants||95% Confidence Interval|Number
684080|NCT01519960|Secondary|Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at 24 Weeks After EOT in Group C|HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <20,000 IU/mL at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|Safety Population.||percentage of participants||95% Confidence Interval|Number
684081|NCT01519960|Secondary|Percentage of Participants With HBV DNA Undetectable at 24 Weeks After EOT in Group C|HBV DNA was quantified using PCR by Roche Taqman. Undetectable HBV DNA was defined as HBV DNA <29 IU/mL. The percentage of participants with HBV DNA undetectable at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|Safety Population.||percentage of participants||95% Confidence Interval|Number
684082|NCT01519960|Secondary|Percentage of Participants With HBV DNA <2,000 IU/mL at 24 Weeks After EOT in Group C|HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA <2,000 IU/mL at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|Safety Population.||percentage of participants||95% Confidence Interval|Number
684083|NCT01519960|Secondary|Percentage of Participants With HBV DNA <20,000 IU/mL at 24 Weeks After EOT in Group C|HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA <20,000 IU/mL at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|Safety Population.||percentage of participants||95% Confidence Interval|Number
684084|NCT01519960|Secondary|Percentage of Participants With Normal ALT at 24 Weeks After EOT in Group C|Normal ALT was defined as ALT ≤ ULN, where each ULN was given by the laboratory at which the sample was analyzed. The percentage of participants with normal ALT at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|Safety Population.||percentage of participants||95% Confidence Interval|Number
684085|NCT01519960|Secondary|Percentage of Participants With Loss of HBsAg at 24 Weeks After EOT in Group C|The percentage of participants with loss of HBsAg at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|Safety Population.||percentage of participants||95% Confidence Interval|Number
684086|NCT01519960|Secondary|Percentage of Participants With HBsAg Seroconversion at 24 Weeks After EOT in Group C|HBsAg seroconversion was defined as loss of HBsAg and the presence of anti-HBs. The percentage of participants with HBsAg seroconversion at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|Safety Population.||percentage of participants||95% Confidence Interval|Number
684087|NCT01519960|Secondary|Percentage of Participants With Loss of HBeAg at 24 Weeks After EOT in Group C|The percentage of participants with loss of HBeAg at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|Safety Population: All participants who received at least one dose of study drug (if assigned) and had at least one post-baseline safety assessment.||percentage of participants||95% Confidence Interval|Number
684088|NCT01519960|Secondary|Change From Baseline in Quantitative HBV DNA Level in Groups A and B|The change in quantitative HBV DNA from Baseline to each visit was averaged among all participants and expressed in log10 IU/mL.|Weeks 12, 24, 36, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)|ITT Population. All participants were included in the endpoint analysis. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.||log10 IU/mL||Standard Deviation|Mean
684089|NCT01519960|Secondary|Quantitative HBV DNA Level in Groups A and B|Quantitative HBV DNA at each visit was averaged among all participants and expressed in log10 IU/mL.|Baseline; Weeks 12, 24, 36, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)|ITT Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.||log10 IU/mL||Standard Deviation|Mean
684090|NCT01519960|Secondary|Quantitative Serum ALT Level in Groups A and B|Quantitative ALT at each visit was averaged among all participants and expressed as a factor of the laboratory-specific ULN (for example, 1 × ULN, 2 × ULN, 3 × ULN).|Baseline; Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)|ITT Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.||factor of ULN||Standard Deviation|Mean
684091|NCT01519960|Secondary|Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at EOT/POP in Groups A and B|HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <2,000 IU/mL at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|ITT Population.||percentage of participants||95% Confidence Interval|Number
684092|NCT01519960|Secondary|Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at EOT/POP in Groups A and B|HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <20,000 IU/mL at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|ITT Population.||percentage of participants||95% Confidence Interval|Number
684353|NCT01517984|Secondary|Allograft Survival Rate|Allograft survival is defined as participants who did not need to be re-transplanted or placed on dialysis due to the failure of their allograft transplantation during the course of this study.|6 to 18 months post-randomization|Intent-to-treat||participants|||Number
684093|NCT01519960|Secondary|Percentage of Participants With HBV DNA Undetectable at EOT/POP in Groups A and B|HBV DNA was quantified using PCR by Roche Taqman. Undetectable HBV DNA was defined as HBV DNA <29 IU/mL. The percentage of participants with HBV DNA undetectable at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|ITT Population.||percentage of participants||95% Confidence Interval|Number
684094|NCT01519960|Secondary|Percentage of Participants With HBV DNA <2,000 IU/mL at EOT/POP in Groups A and B|HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA <2,000 IU/mL at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|ITT Population.||percentage of participants||95% Confidence Interval|Number
684095|NCT01519960|Secondary|Percentage of Participants With HBV DNA <20,000 IU/mL at EOT/POP in Groups A and B|HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA <20,000 IU/mL at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|ITT Population.||percentage of participants||95% Confidence Interval|Number
684096|NCT01519960|Secondary|Percentage of Participants With Normal ALT at EOT/POP in Groups A and B|Normal ALT was defined as ALT ≤ ULN, where each ULN was given by the laboratory at which the sample was analyzed. The percentage of participants with normal ALT at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|ITT Population.||percentage of participants||95% Confidence Interval|Number
684097|NCT01519960|Secondary|Percentage of Participants With Loss of HBsAg at EOT/POP in Groups A and B|The percentage of participants with loss of HBsAg at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|ITT Population.||percentage of participants||95% Confidence Interval|Number
684098|NCT01519960|Secondary|Percentage of Participants With HBsAg Seroconversion at EOT/POP in Groups A and B|HBsAg seroconversion was defined as loss of HBsAg and the presence of anti-HBs. The percentage of participants with HBsAg seroconversion at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|ITT Population.||percentage of participants||95% Confidence Interval|Number
684099|NCT01519960|Secondary|Percentage of Participants With Loss of HBeAg at EOT/POP in Groups A and B|The percentage of participants with loss of HBeAg at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|ITT Population.||percentage of participants||95% Confidence Interval|Number
684100|NCT01519960|Secondary|Percentage of Participants With HBeAg Seroconversion at EOT/POP in Groups A and B|HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. The percentage of participants with HBeAg seroconversion at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|ITT Population.||percentage of participants||95% Confidence Interval|Number
684101|NCT01519960|Secondary|Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at 24 Weeks After EOT/POP in Groups A and B|HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <2,000 IU/mL at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|ITT Population.||percentage of participants||95% Confidence Interval|Number
684102|NCT01519960|Secondary|Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at 24 Weeks After EOT/POP in Groups A and B|HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <20,000 IU/mL at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|ITT Population.||percentage of participants||95% Confidence Interval|Number
684103|NCT01519960|Secondary|Percentage of Participants With HBV DNA Undetectable at 24 Weeks After EOT/POP in Groups A and B|HBV DNA was quantified using PCR by Roche Taqman. Undetectable HBV DNA was defined as HBV DNA <29 IU/mL. The percentage of participants with HBV DNA undetectable at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|ITT Population.||percentage of participants||95% Confidence Interval|Number
684104|NCT01519960|Secondary|Percentage of Participants With HBV DNA <2,000 IU/mL at 24 Weeks After EOT/POP in Groups A and B|HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA <2,000 IU/mL at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|ITT Population.||percentage of participants||95% Confidence Interval|Number
684105|NCT01519960|Secondary|Percentage of Participants With HBV Deoxyribonucleic Acid (DNA) <20,000 International Units Per Milliliter (IU/mL) at 24 Weeks After EOT/POP in Groups A and B|HBV DNA was quantified using polymerase chain reaction (PCR) by Roche Taqman. The percentage of participants with HBV DNA <20,000 IU/mL at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|ITT Population.||percentage of participants||95% Confidence Interval|Number
684106|NCT01519960|Secondary|Percentage of Participants With Normal ALT at 24 Weeks After EOT/POP in Groups A and B|Normal ALT was defined as ALT less than or equal to (≤) ULN, where each ULN was given by the laboratory at which the sample was analyzed. The percentage of participants with normal ALT at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|ITT Population.||percentage of participants||95% Confidence Interval|Number
684107|NCT01519960|Secondary|Percentage of Participants With Loss of HBsAg at 24 Weeks After EOT/POP in Groups A and B|The percentage of participants with loss of HBsAg at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|ITT Population.||percentage of participants||95% Confidence Interval|Number
684108|NCT01519960|Secondary|Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion at 24 Weeks After EOT/POP in Groups A and B|HBsAg seroconversion was defined as loss of HBsAg and the presence of hepatitis B surface antibody (anti-HBs). The percentage of participants with HBsAg seroconversion at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|ITT Population.||percentage of participants||95% Confidence Interval|Number
684109|NCT01519960|Secondary|Percentage of Participants With Loss of HBeAg at 24 Weeks After EOT/POP in Groups A and B|The percentage of participants with loss of HBeAg at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|ITT Population.||percentage of participants||95% Confidence Interval|Number
684110|NCT01519960|Primary|Percentage of Participants With HBeAg Seroconversion at 24 Weeks After End of Treatment (EOT)/POP in Groups A and B|HBeAg seroconversion was defined as loss of HBeAg and the presence of hepatitis B envelope antibody (anti-HBe). The percentage of participants with HBeAg seroconversion at 24 weeks after EOT/POP was reported. The 95 percent (%) confidence interval (CI) was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|Intent-to-Treat (ITT) Population: All randomized participants regardless of treatment received.||percentage of participants||95% Confidence Interval|Number
684111|NCT01519934|Secondary|Patient Satisfaction|Percentage of subjects reporting satisfaction as measured using a Patient Satisfaction Questionnaire.|180 days post-treatment|||percentage of participants|||Number
684112|NCT01519934|Secondary|Subject Perception of Age|"Percentage of subjects rated as looking younger as measured using a Subject Perception of Age questionnaire."|Baseline to 180 days post-treatment|||percentage of participants|||Number
684113|NCT01519934|Secondary|Overall Aesthetic Improvement|"Overall aesthetic improvement was assessed based on a Global Aesthetic Improvement Scale (GAIS) scores; PGAIS completed by a clinician assessor, SGAIS completed by the study subject. The GAIS is 5-point scale (1-5) describing an overall assessment as follows:
= Very Much Improved
= Much Improved
= Improved
= No Change
= Worse"|Baseline to 180 days post-treatment|||percentage of participants|||Number
684114|NCT01519934|Primary|Improvement in Overall Lifting and Tightening of the Skin|Determined by a masked, qualitative assessment of photographs at 180 days post treatment compared to pre-treatment baseline photographs. A panel of three blinded assessors reviewed pre-treatment and post-treatment photos. Each blinded assessor was provided an identical set of pre-treatment and Day 180 post-treatment photos to assess. The pre/post treatment photos were consistent in lighting, subject positioning and focus. The visit interval of each photo, i.e. pre and post treatment, was NOT marked. Each blinded assessor conducted their assessment independently with no input from another blinded assessor, comparing each set of photos. Each assessor indicated those subjects assessed as improved.|Baseline to 180 days post-treatment|||percentage of participants|||Number
684115|NCT01519921|Secondary|Number of Participants With Any Adverse Events and Any Serious Adverse Events|An adverse event (AE) was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A Serious Adverse Events (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Participants with any AEs and any SAEs have been presented.|Up to Week 72|Safety population included participants who received at least one dose of study medication and who had at least one post-baseline safety assessment.||Participants|||Number
684116|NCT01519921|Secondary|Percentage of Participants With Hepatitis B Surface Antigen Seroconversion At Week 48 and Week 72|A responder was a participant with loss of HBsAg and presence of anti-HBs at EOT and EOF period.|Week 48 and Week 72|The ITT population included all participants who received at least one dose of study drug.||Percentage of participants||95% Confidence Interval|Number
684117|NCT01519921|Secondary|Percentage of Participants With Loss of Hepatitis B Surface Antigen At Week 48 and Week 72|A responder was a participant who were analysed with loss of Hepatitis B Surface Antigen (HBsAg) at EOT and EOF period.|Week 48 and Week 72|The ITT population included all participants who received at least one dose of study drug.||Percentage of participants||95% Confidence Interval|Number
684118|NCT01519921|Secondary|Percentage of Participants With Hepatitis B Virus e Antigen Seroconversion|A responder was a participant with loss of HBeAg and presence of anti-HBe at EOT and EOF period.|Week 48 and Week 72|The ITT population included all participants who received at least one dose of study drug.||Percentage of participants||95% Confidence Interval|Number
684119|NCT01519921|Secondary|Percentage of Participants With a Combined Response At Week 48 and Week 72|A responder with Combined Response was a participant with HBV-DNA<100,000 copies/mL, HBeAg seroconversion (i.e. loss of HBeAg and presence of anti-HBe) and ALT normalization at EOT and EOF period.|Week 48 and Week 72|The ITT population included all participants who received at least one dose of study drug.||Percentage of participants||95% Confidence Interval|Number
684120|NCT01519921|Secondary|Percentage of Participants With Hepatitis B Virus DNA Below the Limit of Detection At Week 48 and Week 72|Participants with HBV-DNA below the limit of detection i.e. <174 copies/mL at EOT and EOF period were responders.|Week 48 and Week 72|The ITT population included all participants who received at least one dose of study drug.||Percentage of participants||95% Confidence Interval|Number
684121|NCT01519921|Secondary|Percentage of Participants With ALT Normalization At Week 48 and Week 72|Participants with ALT less than the upper limit of normal (ULN) at end of treatment (EOT) and EOF period were responders.|Week 48 and Week 72|The ITT population included all participants who received at least one dose of study drug.||percentage of participants||95% Confidence Interval|Number
684122|NCT01519921|Primary|Percentage of Participants With Hepatitis B Virus e Antigen Loss At Week 72|Participants with loss of hepatitis B virus e antigen (HBeAg) at the EOF period (24 weeks after the end of treatment) were classified as responders.|Week 72|The ITT population included all participants who received at least one dose of study drug.||Percentage of participants||95% Confidence Interval|Number
684123|NCT01519921|Primary|Percentage of Participants With Hepatitis B Virus DNA <100,000 Copies/mL At Week 72|Participants who had Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) levels below 100,000 copies per milliliter (mL) at the end of follow-up (EOF) period (24 weeks after the end of treatment) were classified as responders.|Week 72|Intent-to-treat (ITT) population included all participants who received at least one dose of study drug.||percentage of participants||95% Confidence Interval|Number
684124|NCT01519882|Secondary|Change From Baseline in the Total Number of Turnings in Bed to Week 4 of the Maintenance Period|"Polysomnography (PSG) was performed for the 2 consecutive nights prior to Day 1 and the 2 consecutive nights prior Week 4 of the Maintenance Period.
Readings from the first night of the PSG will not be used for analysis as this is considered an adaptation night.
The subject was not allowed to sleep during the daytime on the day of a PSG reading. The PSG was recorded for a minimum of 6 h and a maximum of 8 h.
The number of turnings in bed was determined via a postural sensor placed on the subject’s chest."|From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)|||Number of turnings in bed|||Number
684125|NCT01519882|Secondary|Change From Baseline in the Total Wake Time After Sleep Onset (WASO) to Week 4 of the Maintenance Period|"Polysomnography (PSG) was performed for the 2 consecutive nights prior to Day 1 and the 2 consecutive nights prior Week 4 of the Maintenance Period.
Readings from the first night of the PSG will not be used for analysis as this is considered an adaptation night.
The subject was not allowed to sleep during the daytime on the day of a PSG reading. The PSG was recorded for a minimum of 6 h and a maximum of 8 h.
Sleep stages and time spent in each sleep stage were determined from EEG readings. WASO was calculated by:
(Time in bed (Period between lights off and lights on))-(Sleep time)."|From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)|||minutes||Standard Deviation|Mean
684126|NCT01519882|Secondary|Change From Baseline in the Nocturnal Akinesia, Dystonia and Cramps Score (NADCS) to Week 4 of the Maintenance Period|The NADCS assesses nocturnal akinesia, dystonia, and cramps using an ordinal severity scale. While a score of 0 = normal and 4 = maximal severity, subjects can also rate their symptoms with values of 0.5, 1.5, 2.5, and 3.5. The nocturnal akinesia score was used to evaluate motor performance while the dystonia and cramps score was used to evaluate pain. A negative value in Change from Baseline indicates an improvement.|From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)|||units on a scale||Standard Deviation|Mean
684127|NCT01519882|Secondary|Change From Baseline in the Nocturnal Akinesia, Dystonia, and Cramps Score (NADCS) to Day 1 of the Maintenance Period|The NADCS assesses nocturnal akinesia, dystonia, and cramps using an ordinal severity scale. While a score of 0 = normal and 4 = maximal severity, subjects can also rate their symptoms with values of 0.5, 1.5, 2.5, and 3.5. The nocturnal akinesia score was used to evaluate motor performance while the dystonia and cramps score was used to evaluate pain. A negative value in Change from Baseline indicates an improvement.|From Baseline to Day 1 of the Maintenance Period (up to 7 weeks post-baseline)|||units on a scale||Standard Deviation|Mean
684128|NCT01519882|Secondary|Change From Baseline in the Sleep Period Time in Non-Rapid Eye Movement (Non-REM) Sleep to Week 4 of the Maintenance Period|"Polysomnography (PSG) was performed for the 2 consecutive nights prior to Day 1 and the 2 consecutive nights prior Week 4 of the Maintenance Period.
Readings from the first night of the PSG will not be used for analysis as this is considered an adaptation night.
The subject was not allowed to sleep during the daytime on the day of a PSG reading. The PSG was recorded for a minimum of 6 h and a maximum of 8 h.
The sleep period time in stage 3 non-REM was derived from the hypnogram, based on Electroencephalogram (EEG), Electro-myogram (EMG), Electro-oculogram (EOG) and Electrocardiogram (ECG). Change from Baseline is calculated by:
(Stage 3 non-REM time (in minutes) at Baseline)- (Stage 3 non-REM time (in minutes) at Week 4 of the MP)."|From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)|||minutes||Standard Deviation|Mean
684129|NCT01519882|Secondary|Change From Baseline in the Epworth Sleepiness Score (ESS) to Week 4 of the Maintenance Period|"The ESS measures the subject’s general level of daytime sleepiness. The 8 items of this scale assess the probability of falling asleep in a variety of situations. Each item is scored by the subject using the following categories:
0 = would never doze, 1 = slight chance of dozing, 2 = moderate chance of dozing, and 4 = high chance of dozing.
The ESS score ranges from 0 to 32, with higher values indicating a higher level of daytime sleepiness. A negative value in Change from Baseline indicates a decrease in daytime sleepiness."|From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)|||units on a scale||Standard Deviation|Mean
684130|NCT01519882|Secondary|Change From Baseline in the Epworth Sleepiness Score (ESS) to Day 1 of the Maintenance Period|"The ESS measures the subject’s general level of daytime sleepiness. The 8 items of this scale assess the probability of falling asleep in a variety of situations. Each item is scored by the subject using the following categories:
0 = would never doze, 1 = slight chance of dozing, 2 = moderate chance of dozing, and 4 = high chance of dozing.
The ESS score ranges from 0 to 32, with higher values indicating a higher level of daytime sleepiness. A negative value in Change from Baseline indicates a decrease in daytime sleepiness."|From Baseline to Day 1 of the Maintenance Period (up to 7 weeks post-baseline)|||units on a scale||Standard Deviation|Mean
684131|NCT01519882|Secondary|Change From Baseline in the Parkinson's Disease Sleep Scale Score Version 2 (PDSS2) to Week 4 of the Maintenance Period|"The PDSS2 is a scale to assess sleep and nocturnal disability in Parkinson’s Disease during the previous 7 days, and is designed for self-completion by the subject. The updated version (PDSS2) contains 15 questions to be answered using a 5-point Likert scale, where 0 = never, 1 = occasionally, 2 = sometimes, 3 = often, and 4 = very often.
Thus, PDSS2 score ranges from 0-60, with higher scores indicating worse sleep and higher nocturnal disability. A negative value in Change from Baseline indicates improved sleep and less nocturnal disability."|From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)|||units on a scale||Standard Deviation|Mean
684132|NCT01519882|Secondary|Change From Baseline in the Parkinson’s Disease Sleep Scale Score Version 2 (PDSS2) to Day 1 of the Maintenance Period|"The PDSS is a scale to assess sleep and nocturnal disability in Parkinson’s Disease during the previous 7 days, and is designed for self-completion by the subject. The updated version (PDSS2) contains 15 questions to be answered using a 5-point Likert scale, where 0 = never, 1 = occasionally, 2 = sometimes, 3 = often, and 4 = very often.
Thus, PDSS2 score ranges from 0-60, with higher scores indicating worse sleep and higher nocturnal disability. A negative value in Change from Baseline indicates improved sleep and less nocturnal disability."|From Baseline to Day 1 of the Maintenance Period (up to 7 weeks post-baseline)|||units on a scale||Standard Deviation|Mean
684133|NCT01519882|Primary|Percentage Change From Baseline in Sleep Efficiency Index (SEI) to Week 4 of the Maintenance Period|"The Sleep Efficiency Index in percent is the ratio of total sleep time (based on Polysomnography recordings) to time in bed (period between lights off and lights on)."|From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)|||percentage change||Standard Deviation|Mean
684134|NCT01519817|Secondary|Changes in Soluble Cluster of Differentiation 40L (sCD40L)|Blood samples were collected and changes in serum levels of soluble sCD27 were assessed by enzyme-linked immunosorbent assay (ELISA). Significance of changes in soluble sCD40L was determined by p value (Wilcoxon test) and the median and interquartile range of data.|Pre (Baseline) and Day 85 after 6 vaccinations|Due to insufficient samples at some time points in some patients, all participants were not analyzed in dose levels 2, 3 and 4; thus a statistical analysis was not performed.||ng/ml||Inter-Quartile Range|Median
684135|NCT01519817|Secondary|Median Ratio of Soluble Cluster of Differentiation 27:40L (sCD27:sCD40L)|Blood samples were collected and changes in serum levels of the ratio of soluble sCD27:sCD40L was assessed by enzyme-linked immunosorbent assay (ELISA). Significance of changes in soluble sCD27:sCD40L was determined by p value (Wilcoxon test) and the median and interquartile range of data.|Pre (Baseline) and Day 85 after 6 vaccinations|Due to insufficient samples at some time points in some patients, all participants were not analyzed in dose levels 2, 3 and 4; thus a statistical analysis was not performed.||Ratio||Inter-Quartile Range|Median
684136|NCT01519817|Secondary|Changes in Soluble Cluster of Differentiation 27 (sCD27)|Blood samples were collected and changes in serum levels of soluble sCD27 were assessed by enzyme-linked immunosorbent assay (ELISA). Significance of changes in soluble sCD27 was determined by p value (Wilcoxon test) and the median and interquartile range of data.|Pre (Baseline) and Day 85 after 6 vaccinations|Due to insufficient samples at some time points in some patients, all participants were not analyzed in dose levels 2, 3 and 4; thus a statistical analysis was not performed.||U/ml||Inter-Quartile Range|Median
684137|NCT01519817|Secondary|Changes in Serum Levels of Cytokines|Blood samples were collected and changes in serum levels of cytokines interferon gamma (IFNg), Interleukin 10 (IL-10), Interleukin 12 (IL-12)p70, Interleukin 1b (IL-1b), Interleukin 2 (IL-2), Interleukin 6 (IL-6), Interleukin 8 (IL-8), and tumor necrosis factor (TNF) were assessed by the multiplexed mesoscale assay. Significance of changes in serum levels of cytokines was determined by p value (Wilcoxon test) and the median and interquartile range of data.|Pre (Baseline) and Day 85 after 6 vaccinations|Due to insufficient samples at some time points in some patients, all participants were not analyzed in dose levels 2, 3 and 4; thus a statistical analysis was not performed.||pg/ml||Inter-Quartile Range|Median
684138|NCT01519817|Secondary|Changes in Immune Cell Subsets in Peripheral Blood Mononuclear Cells (PBMC)|Blood samples will be collected via apheresis and analyzed by multicolor flow cytometry in PBMCs for cluster of differentiation 4 (CD4), cluster of differentiation 8 (CD8), Natural Killer (NK), Natural Killer T (NKT), conventional dendritic cell (cDC), plasmacytoid dendritic cell (pDC), myeloid-derived suppressor cell (MDSC), Tregs, CD4 central memory (CD4 CM), CD4 effector memory (CD4 EM), CD4 terminal effector memory (CD4 EMRA), CD4 naïve, CD8 CM, CD8 EM, CD8 EMRA, and CD8 naïve cells. Significance of changes in immune cells was determined by p value (Wilcoxon test) and the median and interquartile range of data.|Pre (Baseline) and Day 85 after 6 vaccinations|Due to insufficient samples at some time points in some patients, all participants were not analyzed in dose levels 2, 3 and 4; thus a statistical analysis was not performed.||percentage of PBMC||Inter-Quartile Range|Median
684139|NCT01519817|Secondary|Number of Participants With a Clinical Benefit Assessed by the Response Evaluation Criteria in Solid Tumors (RECIST)|Clinical benefit is defined as partial response (PR) or stable disease (SD) and was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Partial response is ≥30% decrease in the sum of greatest diameters/no new lesions. Progressive disease is ≥20% increase in the sum of greatest diameters/new lesions. Stable disease does not meet criteria for complete response (disappearance of all lesions; no new lesions), partial response, or progressive disease.|3 and 5 months restaging|One participant was not evaluable and came off study due to infection prior to restaging. Two participants were not evaluable due to withdrawal from the study or lack of measurable disease. Three patients with stable disease at 3 months elected to pursue alternate treatment and did not have 5 month restaging.||Participants|||Count of Participants
684140|NCT01519817|Primary|Count of Participants With Adverse Events of Escalating Doses of Yeast Brachyury ( GI- 6301) Vaccine|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. A non-serious adverse event is any untoward medical occurrence.|4 years and 25 days|||Participants|||Count of Participants
684141|NCT01519817|Primary|Number of Participants With Brachyury-Specific T-cell Responses|A fluorescense activated cell sorting (FACS)-based assay for cluster of differentiation 4 (CD4) or cluster of differentiation 8 (CD8) T-cells expressing the cytokines interferon (IFN) gamma, interleukin 2 (IL2), and tumor necrosis factor (TNF) alpha, and/or cluster of differentiation 107a (CD107a) (a marker for lytic potential) was used to determine the numbers of participants showing development or enhancement of the level of brachyury-specific T-cells after vaccination.|Baseline (pre-vaccination) and approximately day 84 (after 6 vaccinations)|Sufficient peripheral blood mononuclear cells (PBMCs) were available before and after vaccination from 31 of 34 patients to analyze brachyury-specific CD4 and CD8 T-cell responses.||Participants|||Count of Participants
684142|NCT01519791|Secondary|Percentage of Subjects Achieving Low Disease Activity (LDA) at Week 52|LDA is defined as achieving a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) ≤ 3.2.|Week 52|Full Analysis Set Period 1 (FAS1) with Non-Responder Imputation (NRI). FAS1 consisted of all subjects with valid Baseline and valid post-Baseline efficacy measurement within Period 1 for DAS28(ESR). For NRI, a subject having missing data for the time point assessed was conservatively counted as a nonremitter or nonresponder.||percentage of subjects|||Number
684143|NCT01519791|Secondary|Interference With Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52|The Arthritis interference in the last month with household work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference).|Week 52|Full Analysis Set Period 1 (FAS1) with Last Observation Carried Forward (LOCF). The FAS1 consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement within Period 1 for the primary efficacy assessment of DAS28(ESR). Missing WPS-RA values were imputed using LOCF.||units on a scale||Standard Deviation|Mean
684144|NCT01519791|Secondary|Number of Days Missed of Family/Social/Leisure Activities (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52|Number of days missed of family/social/leisure activities in the last month.|Week 52|Full Analysis Set Period 1 (FAS1) with Last Observation Carried Forward (LOCF). The FAS1 consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement within Period 1 for the primary efficacy assessment of DAS28(ESR). Missing WPS-RA values were imputed using LOCF.||days||Standard Deviation|Mean
684145|NCT01519791|Secondary|Number of Days With Hired Outside Help (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52|Number of days with hired outside help in the last month.|Week 52|Full Analysis Set Period 1 (FAS1) with Last Observation Carried Forward (LOCF). The FAS1 consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement within Period 1 for the primary efficacy assessment of DAS28(ESR). Missing WPS-RA values were imputed using LOCF.||days||Standard Deviation|Mean
684146|NCT01519791|Secondary|Number of Days With Reduced Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52|Number of days with reduced household work productivity in the last month.|Week 52|Full Analysis Set Period 1 (FAS1) with Last Observation Carried Forward (LOCF). The FAS1 consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement within Period 1 for the primary efficacy assessment of DAS28(ESR). Missing WPS-RA values were imputed using LOCF.||days||Standard Deviation|Mean
684147|NCT01519791|Secondary|Number of Days With no Household Work (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52|Number of days with no household work in the last month.|Week 52|Full Analysis Set Period 1 (FAS1) with Last Observation Carried Forward (LOCF). The FAS1 consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement within Period 1 for the primary efficacy assessment of DAS28(ESR). Missing WPS-RA values were imputed using LOCF.||days||Standard Deviation|Mean
684148|NCT01519791|Secondary|Interference With Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52|The Arthritis interference in the last month with work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference) for employed subjects.|Week 52|Full Analysis Set Period 1 (FAS1) with Last Observation Carried Forward (LOCF). The FAS1 consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement within Period 1 for the primary efficacy assessment of DAS28(ESR). Missing WPS-RA values were imputed using LOCF.||units on a scale||Standard Deviation|Mean
684149|NCT01519791|Secondary|Number of Work Days With Reduced Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52|Number of work days with reduced productivity in the last month for employed subjects.|Week 52|Full Analysis Set Period 1 (FAS1) with Last Observation Carried Forward (LOCF). The FAS1 consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement within Period 1 for the primary efficacy assessment of DAS28(ESR). Missing WPS-RA values were imputed using LOCF.||days||Standard Deviation|Mean
684150|NCT01519791|Secondary|Number of Work Days Missed (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52|Number of work days missed in the last month for employed subjects.|Week 52|Full Analysis Set Period 1 (FAS1) with Last Observation Carried Forward (LOCF). The FAS1 consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement within Period 1 for the primary efficacy assessment of DAS28(ESR). Missing WPS-RA values were imputed using LOCF.||days||Standard Deviation|Mean
684151|NCT01519791|Secondary|Change From Baseline in the Bristol Rheumatoid Arthritis Fatigue- Multidimensional Questionnaire (BRAF-MDQ) Total Score to Week 52|"BRAF-MDQ total score ranges from 0 to 70 (with higher scores indicating worse fatigue).
A negative value in BRAF-MDQ change from Baseline indicates an improvement from Baseline."|From Baseline (Week 0) to Week 52|Full Analysis Set Period 1 (FAS1) with Last Observation Carried Forward (LOCF). The FAS1 consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement within Period 1 for the primary efficacy assessment of DAS28(ESR). Missing BRAF-MDQ values were imputed using LOCF.||units on a scale||Standard Error|Least Squares Mean
684152|NCT01519791|Secondary|Change From Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) to Week 52|"The domains of the HAQ-DI are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities.
The total score ranges from 0 (no difficulty) to 3 (unable to do) with lower scores meaning lower disability.
A negative value in HAQ-DI change from Baseline indicates an improvement from Baseline."|From Baseline (Week 0) to Week 52|Full Analysis Set Period 1 (FAS1) with Last Observation Carried Forward (LOCF). The FAS1 consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement within Period 1 for the primary efficacy assessment of DAS28(ESR). Missing HAQ-DI values were imputed using LOCF.||units on a scale||Standard Error|Least Squares Mean
684153|NCT01519791|Secondary|Percentage of Subjects With a Health Assessment Questionnaire- Disability Index (HAQ-DI) ≤ 0.5 at Week 52|"Normative physical function is defined as HAQ-DI score ≤ 0.5. The domains of the HAQ-DI are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities.
The total score ranges from 0 to 3 with lower scores meaning lower disability."|Week 52|Full Analysis Set Period 1 (FAS1) with Non-Responder Imputation (NRI). FAS1 consisted of all subjects with valid Baseline and valid post-Baseline efficacy measurement within Period 1 for DAS28(ESR). For NRI, a subject having missing data for the time point assessed was conservatively counted as a nonremitter or nonresponder.||percentage of subjects|||Number
684154|NCT01519791|Secondary|Change From Baseline in Simplified Disease Activity Index (SDAI) to Week 52|"SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm), Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in mm) and C-Reactive Protein (CRP in mg/L). 28 joints are examined where a lower score indicates less disease activity.
The SDAI score ranges from 0 to 86, with a negative value in SDAI change from Baseline indicating an improvement from Baseline."|From Baseline (Week 0) to Week 52|Full Analysis Set Period 1 (FAS1) with Last Observation Carried Forward (LOCF). The FAS1 consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement within Period 1 for the primary efficacy assessment of DAS28(ESR). Missing SDAI values were imputed using LOCF.||units on a scale||Standard Error|Least Squares Mean
684155|NCT01519791|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) to Week 52|"CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm), and Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in mm). 28 joints are examined where a lower score indicates less disease activity.
The CDAI score ranges from 0 to 76, with a negative value in CDAI change from Baseline indicating an improvement from Baseline."|From Baseline (Week 0) to Week 52|Full Analysis Set Period 1 (FAS1) with Last Observation Carried Forward (LOCF). The FAS1 consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement within Period 1 for the primary efficacy assessment of DAS28(ESR). Missing CDAI values were imputed using LOCF.||units on a scale||Standard Error|Least Squares Mean
684156|NCT01519791|Secondary|Change From Baseline in Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) to Week 52|"DAS28[ESR] is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula:
0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x PtGADA, where 28 joints are examined and a lower score indicates less disease activity. A negative value in DAS28[ESR] change from Baseline indicates an improvement from Baseline."|From Baseline (Week 0) to Week 52|Full Analysis Set Period 1 (FAS1) with Last Observation Carried Forward (LOCF). The FAS1 consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement within Period 1 for the primary efficacy assessment of DAS28(ESR). Missing DAS28(ESR) values were imputed using LOCF.||units on a scale||Standard Error|Least Squares Mean
684157|NCT01519791|Secondary|Percentage of Subjects Achieving a Good or Moderate European League Against Rheumatism (EULAR) Response at Week 52|"Good response is defined as:
DAS28[ESR] ≤ 3.2 and decrease from Baseline by > 1.2;
moderate response is defined as achievement of one of the following:
DAS28[ESR] ≤ 3.2 and decrease from Baseline > 0.6 and ≤ 1.2
DAS28[ESR] > 3.2 and ≤ 5.1 and decrease from Baseline > 0.6
DAS28[ESR] > 5.1 and decrease from Baseline >1.2."|From Baseline (Week 0) to Week 52|Full Analysis Set Period 1 (FAS1). The FAS1 consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement within Period 1 for the primary efficacy assessment of DAS28(ESR).||percentage of subjects|||Number
684158|NCT01519791|Secondary|Percentage of Subjects Meeting the 2011 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) Remission Criteria Simplified for Clinical Practice at Week 52|"The 2011 ACR/EULAR remission criteria simplified for clinical practice is defined as:
Tender Joint Count (TJC) ≤ 1, Swollen Joint Count (SJC) ≤ 1 and Patient's Global Assessment of Disease Activity (PtGADA) ≤ 1."|Week 52|Full Analysis Set Period 1 (FAS1) with Non-Responder Imputation (NRI). FAS1 consisted of all subjects with valid Baseline and valid post-Baseline efficacy measurement within Period 1 for DAS28(ESR). For NRI, a subject having missing data for the time point assessed was conservatively counted as a nonremitter or nonresponder.||percentage of subjects|||Number
684159|NCT01519791|Secondary|Percentage of Subjects With Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) < 2.6 at Week 52|"DAS28[ESR] is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula:
0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x PtGADA, where 28 joints are examined and a lower score indicates less disease activity."|Week 52|Full Analysis Set Period 1 (FAS1) with Non-Responder Imputation (NRI). FAS1 consisted of all subjects with valid Baseline and valid post-Baseline efficacy measurement within Period 1 for DAS28(ESR). For NRI, a subject having missing data for the time point assessed was conservatively counted as a nonremitter or nonresponder.||percentage of subjects|||Number
684160|NCT01519791|Secondary|Percentage of Subjects With Simplified Disease Activity Index (SDAI) ≤ 3.3 at Week 52|SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm), Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in mm) and C-Reactive Protein (CRP in mg/L). 28 joints are examined where a lower score indicates less disease activity.|Week 52|Full Analysis Set Period 1 (FAS1) with Non-Responder Imputation (NRI). FAS1 consisted of all subjects with valid Baseline and valid post-Baseline efficacy measurement within Period 1 for DAS28(ESR). For NRI, a subject having missing data for the time point assessed was conservatively counted as a nonremitter or nonresponder.||percentage of subjects|||Number
684161|NCT01519791|Secondary|Percentage of Subjects With Clinical Disease Activity Index (CDAI) ≤ 2.8 at Week 52|CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm), and Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in mm). 28 joints are examined where a lower score indicates less disease activity.|Week 52|Full Analysis Set Period 1 (FAS1) with Non-Responder Imputation (NRI). FAS1 consisted of all subjects with valid Baseline and valid post-Baseline efficacy measurement within Period 1 for DAS28(ESR). For NRI, a subject having missing data for the time point assessed was conservatively counted as a nonremitter or nonresponder.||percentage of subjects|||Number
684162|NCT01519791|Secondary|Percentage of Subjects Meeting the 2011 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) Remission Criteria at Week 52|"The ACR/EULAR 2011 remission criteria is defined as:
Tender Joint Count (TJC) ≤ 1, Swollen Joint Count (SJC) ≤ 1, C-reactive protein (CRP) ≤ 1 mg/dl and Patient's Global Assessment of Disease Activity (PtGADA) ≤ 1."|Week 52|Full Analysis Set Period 1 (FAS1) with Non-Responder Imputation (NRI). FAS1 consisted of all subjects with valid Baseline and valid post-Baseline efficacy measurement within Period 1 for DAS28(ESR). For NRI, a subject having missing data for the time point assessed was conservatively counted as a nonremitter or nonresponder.||percentage of subjects|||Number
684163|NCT01519791|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 52|The assessments are based on a 70 % or greater improvement from Baseline in the number of tender joints, a 70 %, or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).|From Baseline (Week 0) to Week 52|Full Analysis Set Period 1 (FAS1) with Non-Responder Imputation (NRI). FAS1 consisted of all subjects with valid Baseline and valid post-Baseline efficacy measurement within Period 1 for DAS28(ESR). For NRI, a subject having missing data for the time point assessed was conservatively counted as a nonremitter or nonresponder.||percentage of subjects|||Number
684195|NCT01519713|Secondary|Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean of Individual Titer Ratio Following Vaccination With One Dose of Menactra® Vaccine|Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined by using a serum bovine assay using a baby rabbit complement (SBA-BR).|28 Days post-vaccination|Geometric mean titer ratios of antibodies against meningococcal serogroups A, C, Y and W-135 antigens were determined in all enrolled and vaccinated participants, per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
684164|NCT01519791|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 52|The assessments are based on a 50 % or greater improvement from Baseline in the number of tender joints, a 50 %, or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).|From Baseline (Week 0) to Week 52|Full Analysis Set Period 1 (FAS1) with Non-Responder Imputation (NRI). FAS1 consisted of all subjects with valid Baseline and valid post-Baseline efficacy measurement within Period 1 for DAS28(ESR). For NRI, a subject having missing data for the time point assessed was conservatively counted as a nonremitter or nonresponder.||percentage of subjects|||Number
684165|NCT01519791|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 52|The assessments are based on a 20 % or greater improvement from Baseline in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).|From Baseline (Week 0) to Week 52|Full Analysis Set Period 1 (FAS1) with Non-Responder Imputation (NRI). FAS1 consisted of all subjects with valid Baseline and valid post-Baseline efficacy measurement within Period 1 for DAS28(ESR). For NRI, a subject having missing data for the time point assessed was conservatively counted as a nonremitter or nonresponder.||percentage of subjects|||Number
684166|NCT01519791|Secondary|Change From Baseline in the Joint Narrowing Score to Week 52|Joint space narrowing (JSN) was assessed in 15 locations per hand and 6 locations per foot. Joint space narrowing for each location was scored from 0 to 4, with 0 indicating no narrowing. The maximum possible score for JSN in all 30 hand joints was 120. The maximum possible score for JSN in all 12 feet joints was 48. Thus, the maximum possible total JSN score for Hands and feet was 168.|From Baseline (Week 0) to Week 52|The Radiographic Set Period 1 (RAD1) consisted of those subjects in the FAS1 who had provided valid radiographs (ie, radiographs resulting in a nonmissing mTSS score) at Baseline and at Week 52 or the Withdrawal Visit.||units on a scale||Standard Deviation|Mean
684167|NCT01519791|Secondary|Change From Baseline in the Joint Erosion Score to Week 52|"Erosions were assessed in 16 locations per hand and 6 joints per foot. Erosions for each hand location were scored from 0 to 5, with 0 indicating no erosion. Scores 1 to 5 may have included combinations of discrete erosion(s) and/or large erosions. Erosions for each foot joint were scored from 0 to 10, with 0 indicating no erosions.
The maximum possible erosion score for all 32-hand joints was 160. The maximum possible erosion score for all 12 feet joints was 120. Thus, the maximum possible total erosion score for hands and feet was 280."|From Baseline (Week 0) to Week 52|The Radiographic Set Period 1 (RAD1) consisted of those subjects in the FAS1 who had provided valid radiographs (ie, radiographs resulting in a nonmissing mTSS score) at Baseline and at Week 52 or the Withdrawal Visit.||units on a scale||Standard Deviation|Mean
684168|NCT01519791|Secondary|Percentage of Subjects With Radiographic Non-progression From Baseline to Week 52|Radiographic non-progression is defined as change in mTSS ≤ 0.5.|From Baseline (Week 0) to Week 52|The Radiographic Set Period 1 (RAD1) consisted of those subjects in the FAS1 who had provided valid radiographs (ie, radiographs resulting in a nonmissing mTSS score) at Baseline and at Week 52 or the Withdrawal Visit.||percentage of subjects|||Number
684169|NCT01519791|Secondary|Change From Baseline in Modified Total Sharp Score (mTSS) to Week 52|Van der Heijde modified Total Sharp Score (mTSS) is a methodology to assess the degree of joint damage by quantifying the extent of bone erosions and joint space narrowing for 44 and 42 joints, respectively. The mTSS ranges from 0 to 448, with higher scores representing greater damage.|From Baseline (Week 0) to Week 52|The Radiographic Set Period 1 (RAD1) consisted of those subjects in the FAS1 who had provided valid radiographs (ie, radiographs resulting in a nonmissing mTSS score) at Baseline and at Week 52 or the Withdrawal Visit.||units on a scale||Standard Deviation|Mean
684170|NCT01519791|Secondary|Percentage of Subjects in Sustained Low Disease Activity (LDA) at Week 52|Sustained LDA is defined as a Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28[ESR]) ≤ 3.2 at both Weeks 40 and 52.|Week 52|Full Analysis Set Period 1 (FAS1) with Non-Responder Imputation (NRI). FAS1 consisted of all subjects with valid Baseline and valid post-Baseline efficacy measurement within Period 1 for DAS28(ESR). For NRI, a subject having missing data for the time point assessed was conservatively counted as a nonremitter or nonresponder.||percentage of subjects|||Number
684171|NCT01519791|Primary|Percentage of Subjects in Sustained Remission at Week 52|"Sustained remission is defined as a Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28[ESR]) < 2.6 at both Weeks 40 and 52.
DAS28[ESR] is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula:
0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x PtGADA, where 28 joints are examined and a lower score indicates less disease activity."|Week 52|Full Analysis Set Period 1 (FAS1) with Non-Responder Imputation (NRI). FAS1 consisted of all subjects with valid Baseline and valid post-Baseline efficacy measurement within Period 1 for DAS28(ESR). For NRI, a subject having missing data for the time point assessed was conservatively counted as a nonremitter or nonresponder.||percentage of subjects|||Number
684172|NCT01519778|Primary|Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)|Safety will be assessed through summaries of the incidence of AEs and SAEs as well as through summaries of vital signs, physical examinations, ECG findings, and laboratory assessments (hematology, serum chemistry, and urinalysis).|24-31 days|Patients receiving any amount of study drug||participants|||Number
684173|NCT01519765|Secondary|Patient Preference|All patients were given a patient satisfaction survey after delivery. They were asked to select their preference for misoprostol intervention type: buccal, vaginal, or either.|Until 72 hours after delivery|All participants were given the survey however incomplete collection was obtained.||participants|||Number
684443|NCT01516749|Secondary|Change in Dermatology Quality of Life Index (DLQI)|Patient self-administered questionnaire measuring the extent to which disease affects quality of life, range 0-30, with higher score reflecting a larger negative effect of disease on quality of life|Baseline, 8 weeks|Patients who completed 8 weeks of therapy||units on a scale||95% Confidence Interval|Mean
684174|NCT01519765|Secondary|Patient Satisfaction With Buccal Versus Vaginal Misoprostol Administration.|"All patients were given a patient satisfaction survey. Patients were asked to use a Likert scale to rate their experience on the following:
Likert sub-scale: 1 to 5
1=Not at all/ Never to 5= Very Much/ Always
Nausea and vomiting 1=better outcome 5=worse outcome
effectiveness of misoprostol 1=worse outcome 5=better outcome
concerns of misoprostol 1=better outcome 5=worse outcome
overall labor experience 1=worse outcome 5=better outcome Patients will be followed for the duration of their labor(usually up to 72hrs). The satisfaction survey will be conducted after delivery but will evaluate side effects that they recollect in labor."|Until 72 hours after delivery|Patient surveys were requested from all participants however incomplete patient survey collection was obtained.||units on a scale||Full Range|Median
684175|NCT01519765|Secondary|APGARS|"Median (APGAR) score at 5 minutes after delivery. APGAR: Appearance, Pulse, Grimace, Activity, Respiration Apgar scale is determine by evaluating a newborn on 5 categories on a scale from 0 to 2, then summing up the five values.
Score range is 0 to 10. Score above 7 are generally normal. Score below 3 may indicated poor status."|5 minutes after delivery|||score||Full Range|Median
684176|NCT01519765|Secondary|Chorioamnionitis|Percentage of participants affected with chorioamnionitis|Until 48 hours after delivery|||percentage of participants||95% Confidence Interval|Number
684177|NCT01519765|Secondary|Meconium|Percentage of participants who developed meconium was computed. Presence of meconium was evaluated by the delivering physician. P-value was computed using Fisher exact test.|Until delivery|||percentage of participants||95% Confidence Interval|Number
684178|NCT01519765|Secondary|Neonatal Intensive Care Unit (NICU) Admission|"Percentage of participants whose baby was admitted to NICU was computed from time to delivery to time of hospital discharge.
P-value was computed using Fisher Exact test."|Until discharge from hospital|||percentage of participants||95% Confidence Interval|Number
684179|NCT01519765|Secondary|Tachysystole|Fetal heart tracing was reviewed until 4 hours after last misoprostol dose. Percentage of participant with tachysystole were computed. Tachysystole was defined as more than five uterine contractions in 10 minutes. P value was computed using Fisher exact test|Until 4 hours after last misoprostol dose|||percentage of participants||95% Confidence Interval|Number
684180|NCT01519765|Secondary|Tachysystole With Abnormal FHT|"Feta heart tracing was reviewed for every participant until 4 hours from last misoprostol dose.
Percentage of participants who presented with tachysystole and abnormal fetal heart tracing was computed.
Abnormal fetal heart tracing was defined as category 2 and above. Tachysystole was defined as more than 5 uterine contractions within 10 minutes. P values were computed by Fisher exact test."|Until 4 hours after last misoprostol dose|||percentage of participants||95% Confidence Interval|Number
684181|NCT01519765|Secondary|Abnormal Fetal Heart Tracing (FHT)|"Feta heart tracing was reviewed for every participant until 4 hours from last misoprostol dose.
Percentage of participants who presented with abnormal fetal heart tracing was computed.
Abnormal fetal heart tracing was defined as category 2 and 3 fetal heart tracing according to standard criteria.
Abnormal fetal heart tracing included any of the following tachycardia, bradycardia without absent variability, minimal variability, absent variability with or without recurrent decelerations, marked variability, prolonged deceleration and recurrent late deceleration, sinusoidal pattern.
P values were computed by Fisher exact test."|Until 4 hours of last misoprostol dose|||percentage of participants||95% Confidence Interval|Number
684182|NCT01519765|Secondary|Artificial Rupture of Membranes (AROM)|Percentage of participants that required AROM|Until delivery|||percentage of participants||95% Confidence Interval|Number
684183|NCT01519765|Secondary|Foley Bulb|Percentage of participants that required foley bulb use.|Until delivery|||percentage of participants||95% Confidence Interval|Number
684184|NCT01519765|Secondary|Pitocin|Percentage of patients that used pitocin during labor. P-values were computed using Fisher exact test.|Until delivery|||percentage of participants||95% Confidence Interval|Number
684185|NCT01519765|Secondary|Failed Induction of Labor|"Percentage of participants who were determined as a failed induction of labor. Failed induction was defined as no cervical change despite 24 hours of pitocin or 12 hours of pitocin after rupture of membranes.
P value was computed by Fisher exact test."|Until delivery|||percentage of participants||95% Confidence Interval|Number
684186|NCT01519765|Secondary|Arrest of Dilation|"Percentage of participants who presented with arrest of dilation. Arrest of dilation was determined by the delivering physician.
P-value was computed using Fisher exact test."|Until delivery|||percentage of participants||95% Confidence Interval|Number
684187|NCT01519765|Secondary|Number of Misoprostol Doses|Number of misoprostol 25 mcg doses used during induction of labor.|Until delivery|||doses||Full Range|Median
684188|NCT01519765|Secondary|Cesarean Delivery Rate|Percentage of participants who underwent a cesarean delivery was computed. P-value was computed using Fisher's exact test.|Until delivery|||percentage of participants||95% Confidence Interval|Number
684189|NCT01519765|Secondary|Rates of Vaginal Delivery|Percentage of participants who delivered vaginally|Until delivery|||percentage of participants||95% Confidence Interval|Number
684190|NCT01519765|Secondary|Time to Active Labor|Time from induction to active labor. Active labor defined as 4 cm and above. P-value computed by Kruskal-Wallis test.|Until active labor|||hours||Full Range|Median
684191|NCT01519765|Secondary|Time to Delivery|Time from induction to delivery. All participants were included.|Until delivery|||hours||Full Range|Median
684192|NCT01519765|Secondary|Time to Vaginal Delivery|Time from start of induction to vaginal delivery was computed in participants who achieved vaginal delivery.|Start of induction until vaginal delivery|Participants who achieved vaginal delivery were included in the analysis||hours||Full Range|Median
684193|NCT01519765|Primary|Vaginal Delivery Within 24 Hours of Labor Induction|Percentage of participants able to achieve vaginal delivery within 24 hours of labor induction.|Within 24 hours of labor induction|||percentage of participants||95% Confidence Interval|Number
684194|NCT01519713|Secondary|Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Following Vaccination With One Dose of Menactra® Vaccine|"Solicited injection site reactions: Pain, Erythema and Swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.
Grade 3 solicited reactions were defined as: Pain incapacitating (children) and prevents daily activities (adolescents and adults). Fever ≥ 39.0°C; Headache, Malaise and Myalgia, significant, prevents daily activities."|Day 0 up to Day 28 post-vaccination|Solicited injection site and systemic reactions were assessed in all enrolled and vaccinated participants, Intent-to-treat population.||Participants|||Number
684196|NCT01519713|Secondary|Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean Titers Following Vaccination With One Dose of Menactra® Vaccine|Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined by using a serum bovine assay using a baby rabbit complement (SBA-BR).|Days 0 and 28 post-vaccination|Geometric mean titers of antibodies against meningococcal serogroups A, C, Y and W-135 antigens were determined in all enrolled and vaccinated participants, per-protocol population||Titers||95% Confidence Interval|Geometric Mean
684197|NCT01519713|Secondary|Number of Participants With a 4-Fold Rise in Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers on Day 28 From Day 0 Following Vaccination With One Dose of Menactra® Vaccine.|Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined by using a serum bovine assay using a baby rabbit complement (SBA-BR).|28 Days post-vaccination|Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined in all enrolled and vaccinated participants, per-protocol population.||Participants|||Number
684198|NCT01519713|Secondary|Number of Participants With Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers of >=1:8 Following Vaccination With One Dose of Menactra® Vaccine|Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined by using a serum bovine assay using a baby rabbit complement (SBA-BR).|28 Days post-vaccination|Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined in all enrolled and vaccinated participants, per-protocol population.||Participants|||Number
684199|NCT01519713|Primary|Number of Participants With Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers of >=1:128 Following Vaccination With One Dose of Menactra® Vaccine|Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined by using a serum bovine assay using a baby rabbit complement (SBA-BR). Sero protection was defined as SBA-BR titer of ≥ 1:128.|28 Days post-vaccination|Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined in all enrolled and vaccinated participants, per-protocol population.||Participants|||Number
684200|NCT01519700|Secondary|Incidence of Hospitalizations Due to Febrile Neutropenia|Incidence of hospitalizations due to Febrile Neutropenia|21 Weeks/ 6 cycles|SAF-I (alternating safety) set: patients who received at least one dose of study medication after Cycle 1.||participants|||Number
684201|NCT01519700|Secondary|Frequency of Infections|Frequency of infections by cycle and across all cycles|21 Weeks/ 6 cycles|SAF-I (alternating safety) set: patients who received at least one dose of study medication after Cycle 1. Comparison made for alternating versus non-alternating treatment groups.||participants|||Number
684202|NCT01519700|Secondary|Time to Absolute Neutrophil Count Recovery|Time to Absolute Neutrophil Count recovery, defined as the time in days from Absolute Neutrophil Count nadir until the patient's Absolute Neutrophil Count increases to more or equal to 2*10^9 cells/L after the nadir in cycle 1|Cycle 1/ 21 days|FAS (full analysis) set: all patients who received at least one dose of study medication, analyzed according to randomization allocation. In the EP2006 + EP2006 & Neupogen group, one patient’s time to Absolute Neutrophil Count recovery could not be measured as the nadir was the last measured timepoint.||Days||Full Range|Median
684203|NCT01519700|Secondary|Depth of Absolute Neutrophil Count Nadir|Depth of Absolute Neutrophil Count Nadir, defined as the patient's lowest Absolute Neutrophil Count in cycle 1|Cycle 1/ 21 days|FAS (full analysis) set: all patients who received at least one dose of study medication, analyzed according to randomization allocation||10^9 cells/L||Standard Deviation|Mean
684204|NCT01519700|Secondary|Number of Days of Fever|Number of days of fever by cycle. Fever is defined as oral temperature greater than or equal to 38.3°C.|21 weeks/ 6 cycles|PP-I (alternating Per-Protocol) set: randomized patients who completed all six chemotherapy cycles without major protocol violations.||participants|||Number
684205|NCT01519700|Secondary|Incidence of Febrile Neutropenia|Incidence of febrile neutropenia by duraton within each cycle and across all cycles. Febrile neutropenia is defined as oral temperature greater than or equal 38.3°C while having an Absolute Neutrophil Count < 0.5*10^9 cells/L (both measured on the same day)|21 weeks/ 6 cycles|SAF-I (alternating safety) set: patients who received at least one dose of study medication after Cycle 1.||participants|||Number
684206|NCT01519700|Primary|Mean Duration of Grade 4 Neutropenia During Cycle 1 of Chemotherapy|Mean duration of severe neutropenia, defined as the mean number of consecutive days with Grade 4 neutropenia (ANC less than 0.5*10^9 cells/L)|21 days (Cycle 1 of chemotherapy treatment)|PP population||Days||Standard Deviation|Mean
684207|NCT01519674|Secondary|Change From Baseline in Patient Reported Outcome by Use of the Treatment Related Impact Measure - Diabetes.|Estimated mean change from baseline in Treatment Related Impact Measure - Diabetes (TRIM-D) 'total score' to end of trial. The score measured treatment satisfaction. The scores were transformed to a 0−100 scale with higher scores indicating greater satisfaction.|Week 0 to Week 24|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 545 subjects contributed to the statistical analysis at Week 24.||scores||Standard Error|Least Squares Mean
684208|NCT01519674|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes (Nocturnal and Day-time) Classified Both According to the American Diabetes Association (ADA) Definition and to an Additional Definition for Minor Episodes.|Number of treatment emergent hypoglycaemic episodes. Treatment emergent hypoglycaemic episode: if the onset of the episode was on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment. Nocturnal: Time of onset between 00:01 and 05:59 a.m. (both included). Additional minor hypoglycaemic episode: symptomatic or asymptomatic hypoglycaemia with blood glucose (BG) values < 2.8 mmol/L (50 mg/dL) or plasma glucose (PG) < 3.1 mmol/L (56 mg/dL), and which was handled by the subject him/herself.|Week 0 to Week 24|Safety analysis set included all subjects receiving at least one dose of the investigational product.||episodes|||Number
684209|NCT01519674|Secondary|Adverse Events (AEs)|Rate of AEs per 100 years of patient exposure. An adverse event was defined as treatment emergent if the event had onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.|Week 0 to Week 24|Safety analysis set included all subjects receiving at least one dose of the investigational product.||Events/100 years of patient exposure|||Number
684210|NCT01519674|Secondary|Prandial Plasma Glucose (PPG) Overall Mean Increment.|Estimated overall mean post prandial increment after 24 weeks of treatment.|After 24 weeks of treatment|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 557 subjects contributed to the statistical analysis at Week 24.||mmol/L||Standard Error|Least Squares Mean
684211|NCT01519674|Secondary|Prandial Plasma Glucose (PPG) Increments at Dinner.|Estimated mean post prandial increments at dinner after 24 weeks of treatment.|After 24 weeks of treatment|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 550 subjects contributed to the statistical analysis at Week 24.||mmol/L||Standard Error|Least Squares Mean
684212|NCT01519674|Secondary|Prandial Plasma Glucose (PPG) Increments at Lunch.|Estimated mean post prandial increments at lunch after 24 weeks of treatment.|After 24 weeks of treatment|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 548 subjects contributed to the statistical analysis at Week 24.||mmol/L||Standard Error|Least Squares Mean
684213|NCT01519674|Secondary|Prandial Plasma Glucose (PPG) Increments at Breakfast|Estimated mean post prandial increments at breakfast after 24 weeks of treatment.|After 24 weeks of treatment|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 555 subjects contributed to the statistical analysis at Week 24.||mmol/L||Standard Error|Least Squares Mean
684214|NCT01519674|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|Estimated mean change from baseline in fasting plasma glucose (FPG)|Week 0 to Week 24|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 556 subjects contributed to the statistical analysis at Week 24.||mmol/L||Standard Error|Least Squares Mean
684215|NCT01519674|Secondary|Responder for HbA1c, Proportion of Subjects Achieving Pre-defined HbA1c Targets (HbA1c ≤ 6.5%)|Proportion of subjects achieving HbA1c equal to or below 6.5% after 24 weeks of treatment.|After 24 weeks of treatment|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 559 subjects contributed to the statistical analysis at Week 24.||percentage (%) of subjects|||Number
684216|NCT01519674|Secondary|Responder for HbA1c, Proportion of Subjects Achieving Pre-defined HbA1c Targets (HbA1c < 7.0%)|Proportion of subjects achieving HbA1c below 7.0% after 24 weeks of treatment|After 24 weeks of treatment|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 559 subjects contributed to the statistical analysis at Week 24.||percentage (%) of subjects|||Number
684217|NCT01519674|Primary|Change From Baseline in HbA1c (Glycosylated Haemoglobin)|Estimated mean change from baseline in HbA1c after 24 weeks of treatment.|Week 0 to Week 24|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 559 subjects contributed to the statistical analysis at Week 24.||percentage of glycosylated haemoglobin||Standard Error|Least Squares Mean
684218|NCT01519661|Secondary|Time to Use of New Anti-pseudomonal Antibiotic|Time to first use of new anti-pseudomonal antibiotic was analyzed.|Day 337|Safety set The safety set included all participants who received at least one dose of study drug.||Days||95% Confidence Interval|Median
684219|NCT01519661|Secondary|Number of Days of New Anti-pseudomonal Antibiotic Use|The total number of days of new anti-pseudomonal antibiotic use was analyzed.|Day 337|Safety set: The safety set included all participants who received at least one dose of study drug.||Days||Standard Deviation|Mean
684220|NCT01519661|Secondary|Percentage of Participants Who Used New Anti-pseudomonal Antibiotics||Day 337|Safety set: The safety set included all participants who received at least one dose of study drug.||Percentage of participants|||Number
684221|NCT01519661|Secondary|Time to First Hospitalization Due to Serious Respiratory-related Adverse Events|The day of first hospitalization due to serious respiratory-related adverse events was analyzed.|Day 337|Safety set The safety set included all participants who received at least one dose of study drug.||Days||95% Confidence Interval|Median
684222|NCT01519661|Secondary|Number of Hospitalization Days Due to Serious Respiratory-related Adverse Events|The total number of hospitalization days due to serious respiratory-related adverse events was analyzed.|Day 337|Safety set: The safety set included all participants who received at least one dose of study drug.||Days||Standard Deviation|Mean
684223|NCT01519661|Secondary|Percentage of Participants Hospitalized Due to Serious Respiratory-related Adverse Events||Day 337|Safety set: The safety set included all participants who received at least one dose of study drug.||Percentage of participants|||Number
684224|NCT01519661|Secondary|Tobramycin MIC 50 and MIC 90 Values Over All Isolates for the Sum of All Biotypes (Mucoid, Dry and Small Colony Variant) of Pseudomonas Aeruginosa|Tobramycin MIC 50 and MIC 90 values were defined as the lowest concentration of tobramycin required to inhibit 50% and 90%, respectively, of the P. aeruginosa strains tested.|Baseline, day 29, day 85, day 141, day 197, day 253, day 309, day 337|Participants from the safety set who had data at each time point/cycle were analyzed at each time point. The safety set included all participants who received at least one dose of study drug.||ug/mL|||Number
684225|NCT01519661|Secondary|Change From Baseline in Pseudomonas Aeruginosa Colony Forming Units in Sputum|Sputum was collected in sterile containers and cultured for Pseudomonas aeruginosa (Pa.) (quantitative test) and other typical Cystic Fibrosis respiratory pathogens. The Pa. biotypes measured were mucoid, dry and small colony variant. Results are presented for the sum of all biotypes of Pa, with data transformed using a base 10 logarithm.|Baseline, day 1, day 29, day 85, day 141, day 197, day 253, day 309, day 337|Participants from the safety set who had Pa sputum density values at both baseline and the given time point were included in the analysis. The safety set included all participants who received at least one dose of study drug.||log10 Colony Forming Unit (CFU)||Standard Deviation|Mean
684241|NCT01519466|Secondary|HbA1c|"HbA1c will be tested at baseline (day 1) and then again at end of study (approximately day 74).
The percentage of glycosylated hemoglobin in Diabetes Control and Complications Trial (DCCT) units was standardized to the newer International Federation of Clinical Chemistry (IFCC) units (mmol/mol)."|Day 1 compared with Day 74|One FreeStyle InsuLinx group subject was excluded from the analysis due to a protocol deviation.||Percentage of Glycosylated Haemoglobin||Standard Deviation|Mean
684242|NCT01519466|Primary|Time in Target Blood Glucose Range|Masked continuous glucose monitoring data will be collected for two weeks at the start of the study and 2 weeks at the end of the study. Analysis will assess the difference between the assessment and baseline phase for the intervention group. Target blood glucose range is 3.9 to 10.0mmol/l (70 to 180mg/dL)|Day 1-15 compared with Day 60-74|One FreeStyle InsuLinx group subject was excluded from the analysis due to a protocol deviation.||hours per day||Standard Deviation|Mean
684226|NCT01519661|Secondary|Relative Change From Baseline in FEF Rate Over 25 to 75 Percent of Vital Capacity Predicted|Spirometry was performed at each visit. FEV1, FVC, and FEF25-75 were recored at all visits according to American Thoracic Society (ATS) guidelines. FEV1 = the volume of air expired in 1 second. FEV1 % predicted is a normalized value of FEV1 calculated using the Knudsen equation, based upon participant's age, gender and height. FVC (forced vital capacity) = the maximal volume of air exhaled with maximally forced effort from a position of maximal inspiration. FEF25-75 = forced expiratory flow from 25% to 75% of the FVC. Relative change in FEEF25-75 from baseline to pre-dose day X = ((pre-dose day X FEF25-75 – baseline FEF25-75) / baseline FEF25-75) • 100.|Baseline, day 29, day 85, day 141, day 197, day 253, day 309, day 337. All study visits except baseline and day 337 occurred at the end of a 28-day on-treatment period of a cycle. Day 337 was the end of the final 28-day off treatment period.|Participants from the safety set who had values at both baseline and the given assessment day were included in the analysis for that assessment day. Therefore, the 'n' for each assessment day is different. The safety set included all participants who received at least one dose of study drug.||Percent change||Standard Deviation|Mean
684227|NCT01519661|Secondary|Relative Change From Baseline in FVC Percent Predicted|Spirometry was performed at each visit. FEV1, FVC, and FEF25-75 were recorded at all visits according to American Thoracic Society (ATS) guidelines. FEV1 = the volume of air expired in 1 second. FEV1 % predicted is a normalized value of FEV1 calculated using the Knudsen equation, based upon participant's age, gender and height. FVC (forced vital capacity) = the maximal volume of air exhaled with maximally forced effort from a position of maximal inspiration. FEF25-75 = forced expiratory flow from 25% to 75% of the FVC. Relative change in FVC % predicted from baseline to pre-dose day X = ((pre-dose day X FVC % predicted – baseline FVC % predicted) / baseline FVC % predicted) • 100.|Baseline, day 29, day 85, day 141, day 197, day 253, day 309, day 337. All study visits except baseline and day 337 occurred at the end of a 28-day on-treatment period of a cycle. Day 337 was the end of the final 28-day off treatment period.|Participants from the safety set who had values at both baseline and the given assessment day were included in the analysis for that assessment day. Therefore, the 'n' for each assessment day is different. The safety set included all participants who received at least one dose of study drug.||Percent change||Standard Deviation|Mean
684228|NCT01519661|Secondary|Relative Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Percent Predicted|Spirometry was performed at each visit. FEV1, FVC, and FEF25-75 were recorded at all visits according to American Thoracic Society (ATS) guidelines. FEV1 = the volume of air expired in 1 second. FEV1 % predicted is a normalized value of FEV1 calculated using the Knudsen equation, based upon participant's age, gender and height. FVC (forced vital capacity) = the maximal volume of air exhaled with maximally forced effort from a position of maximal inspiration. FEF25-75 = forced expiratory flow from 25% to 75% of the FVC. Relative change in FEV1 % predicted from baseline to pre-dose day X = ((pre-dose day X FEV1 % predicted – baseline FEV1 % predicted) / baseline FEV1 % predicted) • 100.|Baseline, day 29, day 85, day 141, day 197, day 253, day 309, day 337. All study visits except baseline and day 337 occurred at the end of a 28-day on-treatment period of a cycle. Day 337 was the end of the final 28-day off treatment period.|Participants from the safety set who had FEV1 percent predicted values at both baseline and the post baseline time points were analyzed at each given time point. The safety set included all participants who received at least one dose of study drug.||Percent change||Standard Deviation|Mean
684229|NCT01519661|Primary|Percentage of Participants With Treatment Emergent Adverse Events, Serious Adverse Events (SAEs) and Deaths|Adverse events were deemed treatment-emergent if the onset date/time was on or after the date and time of first study drug. All adverse events were included after this time during both on and off-treatment periods.|337 days|Safety set: The safety set included all participants who received at least one dose of study drug.||Percentage of participants|||Number
684230|NCT01519648|Primary|The Rate of Invasive Fungal Infections|Estimate the rate of IFIs in patients with acute leukemia for the first 6 months of chemotherapy (that usually correspond to four courses of chemotherapy), and hematopoietic stem cells transplantation.|6 month|||participants|||Number
684231|NCT01519518|Secondary|Door-to-first Device Time||28 days||||||
684232|NCT01519518|Secondary|Development of Thrombocytopenia||28 days||||||
684233|NCT01519518|Secondary|All Cause Mortality||1 year||||||
684234|NCT01519518|Secondary|For Illustration, and to Allow Comparison With Existing Trials the Rate of Net Adverse Clinical Events (NACE), Combining the Primary Safety and Efficacy Outcomes||28 days||||||
684235|NCT01519518|Secondary|Stent Thrombosis Rate (ARC Definite or Probable)||28 days|||percentage of total participants|||Number
684236|NCT01519518|Secondary|Minor Bleeding: Type 2 Bleeding According to BARC (Bleeding Academic Research Consortium) Definition||28 days|||percentage of total participants|||Number
684237|NCT01519518|Secondary|CKMB Release Following Index Revascularisation Measured With a Single Estimation 12-18 Hours After the Procedure||28 days||||||
684238|NCT01519518|Primary|Type 3-5 Bleeding According to BARC (Bleeding Academic Research Consortium)Definition||28 days|||percentage of total participants|||Number
684239|NCT01519518|Primary|Major Adverse Cardiac Events (MACE) in Terms of the Incidence of All Cause Mortality, Cerebrovascular Accident, Re-infarction and Additional Unplanned Target Lesion Revascularization||28 days|||percentage of total participants|||Number
684240|NCT01519466|Secondary|Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 60.|"The Diabetes Treatment Satisfaction Questionnaire change (DTSQc) score is used to assess relative change in participant satisfaction from baseline. The questionnaire consists of 8 items, 6 of which (1 and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale (-3 to +3). The scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from -18 (much less satisfied) to +18 (much more satisfied).
There is one question to assess the change in satisfaction with perceived frequency of Hypoglycaemia and one question to assess change satisfaction with perceived frequency of Hyperglycaemia. Each question is rated on a 7-point Likert scale (-3 to +3), -3 (much less satisfied) to +3 (much more satisfied).
The 95% confidence intervals for the FreeStyle InsuLinx group DTSQc scores was calculated using a one-sample t-test."|Day 60 compared to day 1|One FreeStyle InsuLinx group subject was excluded from the analysis due to a protocol deviation.||Units on a scale||Standard Deviation|Mean
684243|NCT01519427|Secondary|Overall Survival|Estimated probable duration of life from on-study date to date of death from any cause, using Kaplan-Meier method with censoring (see Analysis Population Description for additional details).|On-study date to date of death from any cause, up to 2 years|All patients are included in the analysis on intention-to-treat basis. Analysis is by Kaplan-Meier method, where death is an event, with censoring for non-expired patients at greater of off-study date or last known alive date.||days||Full Range|Median
684244|NCT01519427|Secondary|Progression-free Survival (PFS)|Estimated probable duration of life without disease progression, from on-study date to earlier of progression date, or date of death from any cause, using the Kaplan-Meier method with censoring (see Analysis Population Description for additional details). Disease progression is defined by Response Evaluation in Solid Tumors (RECIST) v.1.1: >= 20% increase in sum of the longest diameter of target lesions, unequivocal progression of non-target lesions, or appearance of new lesions|On-study to lesser of date of progression or date of death from any cause, up to 2 years|All patients are included in the analysis on intention-to-treat basis. Analysis is by Kaplan-Meier method, where either death or progression is an event, with censoring for non-progressed, non-expired patients at greater of off-study date or last known date alive.||days||Full Range|Median
684245|NCT01519427|Secondary|Changes in Biomarker Expression|Pre-treatment tumor biopsy tissue and blood and day 7-14 tumor biopsy tissue and blood will be examined by immunohistochemistry for expression and phosphorylation of the proteins pERK, pMEK, pAKT, Ki67, pRpS6, CRAF, cyclin D, PDGFr, pPDGFr. IGFr1, and COT/Tp12 for changes from baseline|Before initiation of treatment and at 7-14 days, up to 2 years|This clinical trial was terminated early. The investigators did not perform any biomarker expression analyses.|||||
684246|NCT01519427|Primary|Objective Response|Number of patients in each response category, per Response Evaluation in Solid Tumors (RECIST) v.1.1: complete response (CR), disappearance of target lesions; partial response (PR) >=30% decrease in sum of longest diameter (LD) of target lesions; progressive disease (PD), >=20% increase in sum of LD of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or PR. Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR>PR>SD>PD.|On-treatment date to date of progressive disease (assessed up to 30 days after end of treatment)|All patients with best overall response data; patients are excluded if best overall response data is missing or if the patient is non-evaluable for best overall response.||participants|||Number
684247|NCT01519323|Secondary|Overall Survival (OS)|Overall survival was defined as the time between the date of first treatment to the date of death, regardless of the cause of death. Participants who were alive at the time of the analysis were censored at the date of their last being known alive. Median overall survival was estimated using Kaplan-Meier method and 95% CI for median was computed using the Brookmeyer and Crowley method.|Randomization date of first subject until death (2 years)|Intent to treat population included all participants enrolled.||days||95% Confidence Interval|Median
684248|NCT01519323|Secondary|Progression-free Survival (PFS)|PFS was defined as the time between the day of first treatment and the first documentation of progressive disease or death. Progression was defined as a 20% increase in the sum of the longest diameter of target lesions, the appearance of new lesions and increase of at least 5 mm in the sum of diameters of target lesions. Participants who were withdrawn from the study without documented progression were to be censored at the date of the last known tumor assessment when the participant was known to be progression free. Median PFS was estimated using Kaplan-Meier method and 95% CI for median was computed using the Brookmeyer and Crowley method.|Randomization date of first subject until disease progression or death or which ever occur first (2 years)|Intent to treat population included all participants enrolled.||days||95% Confidence Interval|Median
684249|NCT01519323|Secondary|Clinical Benefit Rate (CBR)|CBR was defined as the number of participants that achieved a CR, PR or stable disease (SD) (SD for at least 6 weeks) as assessed by investigators according to the RECIST v1.1. CR was defined as complete disappearance of all target lesions and non-target disease. PR was defined as at >=30% decrease under baseline of the sum of diameters of all target lesions. SD was defined as steady state of disease with neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD).|Up to 2 years|Intent to treat population included all participants enrolled.||percentage of participants|||Number
684250|NCT01519323|Secondary|Best Overall Response Rate (BORR)|BORR was assessed by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. BORR was defined as the number of participants who achieved a complete response (CR) or partial response (PR). CR was defined as complete disappearance of all target lesions and non-target disease. PR was defined as a >=30% decrease under baseline of the sum of diameters of all target lesions. BORR was summarized along with the associated exact 95% confidence interval (CI) using the method of Clopper–Pearson.|Up to 2 years|Intent to treat population included all participants enrolled.||percentage of participants||95% Confidence Interval|Number
684251|NCT01519323|Secondary|Number of Participants With an Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a patient administered a pharmaceutical product and which did not necessarily have to have a causal relationship with study treatment.|Up to approximately 2 years 11 months|Safety population included all participants who received at least one dose or a partial dose of study treatment.||participants|||Number
684252|NCT01519323|Secondary|Area Under the Concentration-Time Curve for Vemurafenib||Pre-dose, 2, 4, 8, 12 hours post dose on Cycle 1 Day 1 and Cycle 1 Day 22 (each cycle is of 28 days)|Pharmacokinetic (PK) population included all enrolled participants who received at least one dose or a partial dose of study treatment and provided at least one post-dose blood sample for PK analysis.||hour*nanogram per millitre (h*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
684253|NCT01519323|Primary|Maximum Tolerated Dose (MTD)/Recommended Dose|The MTD was defined as the dose level at which six evaluable participants had been treated and at most one participant experienced a dose limiting toxicity (DLT) and the next highest dose level was too toxic. Dose escalation occurred if 0 out of 3 or at most 1 out of 6 participant experienced DLT while being treated at a dose level; otherwise the dose was declared unsafe and thus above the MTD.|Up to 28 days of treatment|A MTD could not be determined in this study because of the low number of participants enrolled.|||||
684254|NCT01519284|Secondary|AUC0-∞ - Area Under the Plasma Concentration-time Curve (AUC) of Levodopa From Time Zero to Infinity|AUC0-∞ - Area under the plasma concentration-time curve (AUC) of levodopa from time zero to infinity.|8 days|||ng.h/mL||Standard Deviation|Mean
684255|NCT01519284|Secondary|AUC0-t - Area Under the Plasma Concentration-time Curve (AUC) of Levodopa From Time Zero to the Last Sampling Time at Which the Drug Concentration Was at or Above the Lower Limit of Quantification.|AUC0-t - Area under the plasma concentration-time curve (AUC) of levodopa from time zero to the last sampling time following a single oral administration of Sinemet® 100/25 on Day 8, and 5 mg, 15 mg and 30 mg BIA 9-1067 once-daily (QD), 200 mg entacapone thrice-daily (TID), and placebo, for 8 days|8 days|||ng.h/mL||Standard Deviation|Mean
684256|NCT01519284|Secondary|Tmax - Time to Reach Maximum Plasma Concentration of Levodopa|Tmax - Time to Reach maximum plasma concentration of levodopa following a single oral administration of Sinemet® 100/25 on Day 8, and 5 mg, 15 mg and 30 mg BIA 9-1067 once-daily (QD), 200 mg entacapone thrice-daily (TID), and placebo, for 8 days.|8 days|||hours||Full Range|Median
684257|NCT01519284|Primary|Cmax - Maximum Plasma Concentration of Levodopa|Cmax - Maximum plasma concentration of levodopa following a single oral administration of Sinemet® 100/25 on Day 8, and 5 mg, 15 mg and 30 mg BIA 9-1067 once-daily (QD), 200 mg entacapone thrice-daily (TID), and placebo, for 8 days|8 days|||ng/mL||Standard Deviation|Mean
684258|NCT01519271|Secondary|Montreal Cognitive Assessment (MoCA)|The MoCA will be used as the global cognitive screening instrument. It will also be administered in the clinical trial at baseline and the final visits of each phase as a secondary outcome measure of global cognition. Scores on the MoCA range from 0-30 with 26-30 indicating normal global cognition.|The MoCA was administered in the beginning and end of each study phase.|Please note this study utilized the crossover design (i.e. participants were exposed to two phases of treatment, one with placebo and one with Exelon patch). The data are comparing differences in treatment groups.||Score on MoCA||Standard Deviation|Mean
684259|NCT01519271|Primary|Alzheimer's Disease Cooperative Study- Clinical Global Impression Change (ADCS-CGIC)|"The ADCS-CGIC is the most commonly used measure of global change in dementia psychopharmacology studies. This assessment is a measure of change, thus it is not appropriate for baseline administration and only administered at the end of phase visit.
The scale rates total improvement on a 7 point scale:
= Very much improved
= Much improved
= Minimally improved
= No change
= Minimally worse
= Much worse
= Very much worse
A participant scoring a 1 or 2 is considered a responder on the CGI scale."|The ADCS-CGIC will be administered at the end of each study phase.|Please note this study utilized the crossover design (i.e. participants were exposed to two phases of treatment, one with placebo and one with Exelon patch). The data are comparing differences in treatment groups. Over the course of this study 2 participants discontinued study participation.||scores on the CGIC||Standard Deviation|Mean
684260|NCT01519245|Secondary|Volume of Blood Loss After 12 Hours|Volume of chest tube loss at 12 hours (assuming the total volume of loss is blood).|12 hours following admission to the Intensive Care Unit|||mL||Standard Deviation|Mean
684261|NCT01519245|Secondary|Volume of Blood Loss at 6 Hours|Volume of chest tube loss at 6 hours (assuming the total volume of loss is blood).|6 hours following admission to the Intensive Care Unit|||mL||Standard Deviation|Mean
684262|NCT01519245|Primary|Number of Units of Packed Red Blood Cells (PRBC) Transfused Following Coronary Artery Bypass Graft Surgery|Research participants were to receive a blood transfusion in the Intensive Care Unit (ICU) post-operatively if hemoglobin reached a nadir of 80g/L, or at the discretion of the intensivist or cardiac surgeon according to patient clinical status. Transfusion was quantified based on the number of units of PRBC received. (1 unit = 1 bag of blood, as prepared by Canadian Blood Services). Clinical status of research participants was followed throughout their duration in the ICU only. Participation in this study ended upon transfer out of the ICU, to the Cardiology Ward.|From ICU admission to transfer to the Cardiology Ward (placebo group = 24.4 hours; trial group = 24.7 hours)|None of the research participants received PRBC transfusion postoperatively in the ICU.||Unit(s) of PRBC|||Number
684263|NCT01519245|Primary|Total Volume of Blood Loss From Mediastinal Chest Tubes at Time of Removal (Assuming the Total Volume of Loss is Blood).|According to standard practice, research participants were be transferred to the intensive care unit (ICU) for post-operative monitoring. Measurement of chest tube output began immediately on arrival to the ICU. Hourly measurements were recorded. Data collection ended upon chest tube removal, or return to the operating room for exploratory surgery due to massive blood loss. As per ICU protocol, chest tubes were be removed when blood loss was recorded to be less than 200mL after six consecutive hours.|From ICU admission post-operatively to mediastinal chest tube removal (placebo group = 20.6 hours; trial group = 19.8 hours)|A total of 44 consented participants were randomized. Prior to unblinding, 3 of the randomized participants were withdrawn from the study due to discovery of ineligibility criteria (1 EF <50%, 1 weight <75kg, 1 CABG x 7). Therefore, a total 41 patients were included in final analysis.||mL||Standard Deviation|Mean
684264|NCT01519206|Secondary|Subject Satisfaction at 90 Days, 180 Days and 1 Year Post-treatment|Subject satisfaction was determined by scores on a patient satisfaction questionnaire (PSQ) completed at 90 days, 180 days and 1 year post-treatment. Subjects indicated how satisfied they were with their study treatment, i.e., Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Pre-treatment and post-treatment photographs were available for viewing at each follow-up visit interval. Subjects also had a mirror available for real time assessment, comparing their image in the mirror with pre-treatment and post-treatment photos.|Baseline to 90 days, 180 days and 1 year post-treatment|Three (3) subjects were lost-to-follow-up. Two (2) subjects missed the 1 year visit.||Percentage of Participants|||Number
684265|NCT01519206|Secondary|Subjects' Assessment of Pain|Subjects' sensory response to the Ulthera treatment exposures were recorded for each anatomical region treated using a validated Numeric Rating Scale (0-10), with 1 representing no pain and 10 representing the worst pain possible. Subjects rated pain for each transducer, in each treatment region. For statistical analyses, NRS scores were averaged for each transducer depth.|During Ulthera treatment|||Units on a scale||Full Range|Mean
684266|NCT01519206|Secondary|Overall Aesthetic Improvement at 60 Days, 90 Days, 180 Days and 1 Year Post-treatment.|"Improvement was assessed based on Global Aesthetic Improvement Scale (GAIS) scores. The GAIS was completed based on a live assessment of the subject and a photographic assessment comparing post-treatment photos to baseline photos. The PGAIS was completed by a clinician assessor; SGAIS was completed by the study subject. The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:
- Very Much Improved
- Much Improved
- Improved
- No Change
- Worse"|Baseline to 60 days, 90 days, 180 days and 1 year post-treatment|Three (3) subjects were lost-to-follow-up. Two (2) additional subjects missed the 1 year visit.||Percentage of Participants|||Number
684267|NCT01519206|Primary|Improvement in Overall Lifting and Tightening of Skin|Improvement in overall lifting and tightening of skin was completed by three masked assessors, completing a qualitative assessment of pre- and post-treatment photographs. Masked photo pairs of pre/post treatment photos of each treated subject were provided to each assessor. Each photo pair was consistent in lighting, position, focus. The visit interval of each photo was NOT marked. Each assessor's review was completed independently, with no input from others, assessing the photos for improvement. If improvement was seen, the blinded assessor was to choose the post-treatment photo. Categories of assessment included Improved, No Change, or Incorrect post-treatment photo chosen. The majority assessment among the 3 blinded assessors for each subject was reported.|Baseline to 90 days post treatment|Thirty-five (35) subjects were enrolled; 3 were screen failures. Thirty-two (32) subjects received study treatment. Three (3) subjects were lost-to-follow-up.||percentage of participants improved|||Number
684268|NCT01519167|Secondary|Number of Subjects Converted to Alternative Sedation or Anesthetic Therapy Due to Failure of Treatment of Study Drug and Rescue Medication||During the treatment period, up to approximately 24 hours|Efficacy Evaluable Population (Participants who received study drug infusion for at least 30 minutes and had no major protocol deviations)||Participants|||Number
684269|NCT01519167|Secondary|Total Amount of Rescue Analgesia (Fentanyl)|Total amount of rescue analgesia (fentanyl) required from the start of IV sedation to completion of the procedure|During the treatment period, up to approximately 24 hours|Number of subjects who received any amount (mg) of rescue fentanyl for analgesia in efficacy evaluable population.||microgram||Standard Deviation|Mean
684270|NCT01519167|Secondary|Total Amount of Rescue Sedation (Midazolam)|Total amount of rescue sedation (midazolam) required from the start of IV sedation to completion of the procedure|During the treatment period, up to approximately 24 hours|Number of subjects who received any amount (mg) of rescue midazolam for sedation in efficacy evaluable population.||milligram||Standard Deviation|Mean
684271|NCT01519167|Secondary|Frequency of Fentanyl Use for Analgesia|Frequency of rescue analgesia (fentanyl) required from the start of IV sedation to completion of the procedure.|During the treatment period, up to approximately 24 hours|Number of subjects who received any amount (mg) of rescue fentanyl for analgesia in efficacy evaluable population.||Occurrence||Full Range|Median
684272|NCT01519167|Secondary|Frequency of Midazolam Required for Sedation|Frequency of rescue sedation (midazolam) required to maintain a subject within the target sedation range (UMSS score greater than 1 or N-PASS score less than -2).|During the treatment period, up to approximately 24 hours|Number of subjects who received any amount (mg) of rescue midazolam for sedation in efficacy evaluable population.||Occurrence||Full Range|Median
684273|NCT01519167|Secondary|Time to First Dose of Rescue Midazolam From Start of Dexmedetomidine Infusion|Kaplan-Meier estimates of time in minutes to first dose of rescue midazolam from onset of study drug infusion|During the treatment period, up to approximately 24 hours|Efficacy Evaluable Population (Participants who received study drug infusion for at least 30 minutes and had no major protocol deviations)||Hours||95% Confidence Interval|Median
684274|NCT01519167|Secondary|Number of Subjects Who Were Adequately Sedated at Least 80% of Time|Subjects who are adequately sedated (UMSS score of 1 to 3 or NPASS score of -5 to -2) at least 80% of the time sedated with the study drug|During the treatment period, up to approximately 24 hours|Efficacy Evaluable Population (Participants who received study drug infusion for at least 30 minutes and had no major protocol deviations)||participants|||Number
684275|NCT01519167|Secondary|Number of Subjects Who Have Undergone Procedures Without Artificial Ventilation or Intervention||During the treatment period, up to approximately 24 hours|Efficacy Evaluable Population (Participants who received study drug infusion for at least 30 minutes and had no major protocol deviations)||participants|||Number
684276|NCT01519167|Secondary|Number of Subjects Not Receiving Rescue Midazolam|Number of subjects who did not receive any rescue midazolam for sedation during the study drug infusion.|During the treatment period, up to approximately 24 hours|Efficacy Evaluable Population (Participants who received study drug infusion for at least 30 minutes and had no major protocol deviations)||participants|||Number
684277|NCT01519167|Primary|Number of Subjects Who Had Success in Sedation|"Success in sedation was defined by a combined endpoint which was the combination of the following:
Subject had adequate level of sedation (University of Michigan Sedation Scale [UMSS] score between 1 to 3 [minimally sedated to deeply sedated] or Neonatal Pain, Agitation and Sedation Scale [N-PASS] score between -5 to -2 [Light sedation]) at least 80% of the time the subject was given the study drug.
Subject had successfully completed the procedure without a need for rescue sedation (Midazolam).
Subject had undergone the procedure without artificial ventilation or intervention to restore baseline or normal hemodynamic status"|From baseline to end of post-treatment period (approximately 24 hours)|Efficacy Evaluable Population (Participants who received study drug infusion for at least 30 minutes and had no major protocol deviations)||participants|||Number
684278|NCT01519089|Secondary|Change From Baseline in American College of Rheumatology (ACR) Component_ Health Assessment Questionnaire - Disability Index (HAQ-DI)|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0=least difficulty and 3=extreme difficulty.|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.||Units on a scale||Standard Deviation|Mean
684279|NCT01519089|Secondary|Change From Baseline in American College of Rheumatology (ACR) Component_ C-Reactive Protein (CRP)|The blood samples were collected at each visit for analysis of CRP with an assay analyzed by the central laboratory.|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.||mg/dL||Standard Deviation|Mean
684317|NCT01518530|Secondary|Efficacy as Per the NDI-Neck Disability Index|The most important instrument used to measure efficacy of treatment in patients with chronic neck pain will be used. A score of 0-50, where 50 denotes maximal disability due to chronic neck pain will be documented.|6 weeks||||||
684280|NCT01519089|Secondary|Change From Baseline in American College of Rheumatology (ACR) Component_ Physician Global Assessment of Arthritis|The rheumatologist investigator assessed how the subject’s overall arthritis appeared at the time of the visit. This was an evaluation based on the subject’s disease signs, functional capacity and physical examination, and was independent of the PGA of arthritis. The rheumatologist investigator’s response was recorded a 100 mm visual analog scale (VAS), where 0 = very good and 100 = very poor.|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.||Units on a scale||Standard Deviation|Mean
684281|NCT01519089|Secondary|Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Global Assessment of Arthritis|Subjects answered the following question, “Considering the possible effects of the arthritis, how are you feeling today?” The subject’s response was recorded with a 100 mm visual analog scale (VAS), where 0 = very well and 100 = very poorly.|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.||Units on a scale||Standard Deviation|Mean
684282|NCT01519089|Secondary|Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Assessment of Arthritis Pain|Subjects assessed the severity of their arthritis pain with a 100 mm visual analog scale (VAS) by placing a mark on the scale between 0 (no pain) and 100 (the most severe pain), which corresponded to the magnitude of their pain.|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.||Units on a scale||Standard Deviation|Mean
684283|NCT01519089|Secondary|Change From Baseline in American College of Rheumatology (ACR) Component_ Swollen Joint Count|Sixty six (66) joints were assessed for swelling by a rheumatologist investigator to determine the number of joints that were considered swelling. The response to pressure/motion on each joint was assessed with the following scale: Present/Absent/Not Done/Not Applicable (for Artificial or missing joints).|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.||Swollen joints||Standard Deviation|Mean
684284|NCT01519089|Secondary|Change From Baseline in American College of Rheumatology (ACR) Component_ Tender/Painful Joint Count|Sixty eight (68) joints were assessed by a rheumatologist investigator to determine the number of joints that were considered tender or painful. The response to pressure/motion on each joint was assessed with the following scale: Present/Absent/Not Done/Not Applicable (for Artificial or missing joints).|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.||Tender/painful joints||Standard Deviation|Mean
684285|NCT01519089|Secondary|Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response|ACR70 response: greater than or equal to (>=) 70 percent (%) improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.||Percentage of participants|||Number
684286|NCT01519089|Secondary|Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response|ACR50 response: greater than or equal to (>=) 50 percent (%) improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.||Percentage of participants|||Number
684287|NCT01519089|Secondary|Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response|ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Week 2, 4, 8, 12, 20, 28, 40, 52|Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.||Percentage of participants|||Number
684288|NCT01519089|Secondary|Joint Pain Assessment (JPA)|The JPA assesses severity of joint pain. The JPA is a horizontal numeric rating scale. Participants were asked to “select the number that best describes any joint pain that participant may have experienced over the past 24 hours” with response options ranging from “0-no joint pain” to “10-worst possible joint pain.”|Baseline, Week 4, 16, 28, 52|The subjects with a medical history of ongoing psoriatic arthritis (that was defined as the MedDRA preferred term for psoriatic arthropathy regardless of meeting the inclusion criteria for the psoriatic arthritis) in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.||Units on a scale||Standard Deviation|Mean
684318|NCT01518530|Primary|Occiflex Device Safety|A meticulous documentation of any serious adverse effect will be made. Any minor side effects will be recorded with an emphasis on the possible relationship to the treatment. The number of minor and serious adverse effects out of 360 therapeutic sessions will be noted.|6 weeks|||Number of adverse effects|||Number
684289|NCT01519089|Secondary|Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category|The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5-point scale (0=clear [no psoriasis]; 1=almost clear; 2=mild; 3=moderate; 4=severe).|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.||Percentage of participants|||Number
684290|NCT01519089|Secondary|Work Limitation Questionnaire (WLQ)|WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5 items); Physical Demands scale (6 items); Mental-Interpersonal Demands Scale (9 items); Output Demands Scale (5 items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). The WLQ Index score is the weighted sum of the scores from the 4 WLQ scales (total score: 0 [no loss] to 100 [complete loss of work]).|Baseline (BL), Week (W) 4, 16, 28, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.||Units on a scale||Standard Deviation|Mean
684291|NCT01519089|Secondary|Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Component Summary Score|36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects are summarized as physical and mental health summary scores. The score range for the physical and mental health scores is 0-100 (100=highest level of functioning).|Week 16, 28, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.||Units on a scale||Standard Deviation|Mean
684292|NCT01519089|Secondary|Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score|36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects are summarized as physical and mental health summary scores. The score range for the physical and mental health scores is 0-100 (100=highest level of functioning).|Week (W) 16, 28, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.||Units on a scale||Standard Deviation|Mean
684293|NCT01519089|Secondary|Dermatology Life Quality Index (DLQI) Score|The DLQI is a 10 item general dermatology questionnaire that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.||Units on a scale||Standard Deviation|Mean
684294|NCT01519089|Secondary|Itch Severity Item (ISI) Score|"ISI assessed severity of itch (pruritus) due to psoriasis. ISI is a single item, horizontal numeric rating scale. Participants were asked to rate your worst itching due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms No itching (0) and Worst possible itching (10) at the ends for post baseline time points. Baseline ISI is average of scores on 7 days prior to start of study treatment."|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.||Units on a scale||Standard Deviation|Mean
684295|NCT01519089|Secondary|Number of Affected Nails|Nail psoriasis is evaluated by the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Total number psoriasis affected nails (presence of psoriatic manifestations on the nail matrix/nail bed) were assessed and reported.|Baseline, Week 8, 16, 20, 28, 40, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.||nails||Standard Deviation|Mean
684296|NCT01519089|Secondary|Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score|The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis.|Week 8, 16, 20, 28, 40, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.||Units on a scale||Standard Deviation|Mean
684319|NCT01518322|Post-Hoc|Of the 22 Subjects With a High FeNO (>50ppb Age 12 Years and Above; >35ppb Age Less Than 12 Years)During the Original Study Visit, Number of Subjects Subsequently Treated With Asthma Medications or Diagnosed With Asthma.|A medical record review of the 22 subjects with a high FeNO Value (>50ppb age 12 years and above; >35ppb age less than 12 years)during the original study visit was conducted. The number of subjects who were either diagnosed with asthma or treated with asthma medications is presented.|4 to 6 months after the original study visit.|Of the 162 subjects in the per-protocol population, 22 had a high FeNO (>50ppb age 12 years and above; >35ppb age less than 12 years). A retrospective medical record review was conducted and the number of subjects either diagnosed with asthma or treated with asthma medications is presented.||participants|||Number
684297|NCT01519089|Secondary|Percentage of Participants Maintaining Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear'|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). Maintenance of PGA response at Week 52 among participants achieving PGA response at Week 16 is reported.|Week 20, 28, 40, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.||Percentage of participants|||Number
684298|NCT01519089|Secondary|Percentage of Participants Maintaining Psoriasis Area and Severity Index 75 (PASI75) Response After Week 16|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of body surface area (BSA) affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response was defined as at least a 75 percent (%) reduction in PASI relative to Baseline. Maintenance of PASI75 response at Week 52 among participants achieving PASI75 response at Week 16 is reported."|Week 20, 28, 40, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.||Percentage of participants|||Number
684299|NCT01519089|Secondary|Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe).|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.||Percentage of participants|||Number
684300|NCT01519089|Secondary|Percentage of Participants With a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear'|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).|Week 2, 4, 8, 12, 20, 28, 40, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.||Percentage of participants|||Number
684301|NCT01519089|Secondary|Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score|The PASI quantifies the severity of a participant's psoriasis based on both, “lesion severity” and the “percent of body surface area (BSA)” affected. Basic characteristics of psoriatic lesions: erythema, induration, and scaling (PASI components) are scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]) according to a 5-point scale: 0 (no involvement); 1 (slight); 2 (moderate); 3 (marked); 4 (very marked). PASI component score range from 0 to 4, where higher scores indicate greater severity of psoriatic lesions.|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.||Units on a scale||Standard Deviation|Mean
684302|NCT01519089|Secondary|Change From Baseline in Psoriasis Area and Severity Index (PASI) Score|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of body surface area (BSA) affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis."|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.||Units on a scale||Standard Deviation|Mean
684320|NCT01518322|Secondary|Subjects With a History of Cough, Wheeze, and/or Shortness of Breath Prior to the Study|The total number of subjects who reported prior episodes of cough, wheeze, and shortness of breath.|anytime prior to the single study visit|A total of 235 subjects were initially deemed eligible for the study and were identified as the All Subjects Population. Following review of the eligibility criteria and FeNO, 73 subjects were excluded from the Per Protocol Population, predominantly because of their prior asthma and COPD history and missing FeNO values.||participants|||Number
684351|NCT01517984|Secondary|Percentage of Participants With New Donor Specific Antibodies (DSAs)|Donor specific antibodies are antibodies that are directed against antigens expressed on donor organs. These antibodies can result in an immune attack on the transplanted organ, increasing risk of graft loss and/or rejection.|6 to 18 months post-randomization|Intent-to-treat||percentage of participants|||Number
684303|NCT01519089|Secondary|Percentage of Participants With a Psoriasis Area and Severity Index (PASI) Score >= 125 Percent of the Baseline PASI Score|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of body surface area (BSA) affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis."|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.||Percentage of participants|||Number
684304|NCT01519089|Secondary|Time to Achieve a Psoriasis Area and Severity Index 90 (PASI90) Response|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring assessed by the investigator, of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI90 response was defined as at least 90% reduction in PASI relative to Baseline. The median time to event is estimated based on Kaplan-Meier product-limit method. Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%."|Week 16|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.||Week||95% Confidence Interval|Median
684305|NCT01519089|Secondary|Time to Achieve a Psoriasis Area and Severity Index 50 (PASI50) Response|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring assessed by the investigator, of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI50 response was defined as at least 50% reduction in PASI relative to Baseline. The median time to event is estimated based on Kaplan-Meier product-limit method. Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%."|Week 16|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.||Week||95% Confidence Interval|Median
684306|NCT01519089|Secondary|Time to Achieve a Psoriasis Area and Severity Index 75 (PASI75) Response|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response was defined as at least 75% reduction in PASI relative to Baseline. The median time to event is estimated based on Kaplan-Meier product-limit method. Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%."|Week 16|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.||Week||95% Confidence Interval|Median
684307|NCT01519089|Secondary|Time to Achieve a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear'|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). Median time to achieve a PGA response up to week 16 is reported. The median time to event is estimated based on Kaplan-Meier product-limit method. Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%.|Week 16|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.||Week||95% Confidence Interval|Median
684308|NCT01519089|Secondary|Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of body surface area (BSA) affected. PASI is a composite scoring assessed by the investigator, of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI90 response was defined as at least a 90 percent (%) reduction in PASI at the each visit relative to Baseline."|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.||Percentage of participants|||Number
684352|NCT01517984|Secondary|Participant Survival Rate|Number of participants who did not die within the course of this study.|6 to 18 months post-transplantation|Intent-to-treat||participants|||Number
684309|NCT01519089|Secondary|Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI50) Response|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of body surface area (BSA) affected. PASI is a composite scoring assessed by the investigator, of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI50 response was defined as at least a 50 percent (%) reduction in PASI at the each visit relative to Baseline."|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.||Percentage of participants|||Number
684310|NCT01519089|Secondary|Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of body surface area (BSA) affected. PASI is a composite scoring assessed by the investigator, of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response was defined as at least a 75 percent (%) reduction in PASI at the each visit relative to Baseline."|Week 2, 4, 8, 12, 20, 28, 40, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.||Percentage of participants|||Number
684311|NCT01519089|Primary|Number of Participants With Malignancy Events _Week 0 Through Follow-up|For all biopsies of potentially malignant tumors, suspicious lymphadenopathy, or possible extranodal LPD, the study site requested the pathologist to send the original slides used to make the definitive diagnosis, ancillary study reports, and the pathologist’s report to the central laboratory for a blinded review by a central pathologist.|Baseline to Follow-up|Participants treated with at least 1 dose of study drugs.||Participants|||Number
684312|NCT01519089|Primary|Number of Participants With Adjudicated Cardiovacular Events|Adjudicated cardiovascular events were assessed by investigators as independent reviewers based on event documentation including: hospital discharge summaries, operative reports, clinic notes, ECGs, diagnostic enzymes, results of other diagnostic tests, autopsy reports and death certificate information; specific requirements vary with the event requiring adjudication.|Baseline to Follow-up|Participants treated with at least 1 dose of study drugs.||Participants|||Number
684313|NCT01519089|Primary|Proportion of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 16|ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Week 16|Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.||Percentage of participants|||Number
684314|NCT01519089|Primary|Percentage of Participants With a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 16|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).|Week 16|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.||Percentage of participants|||Number
684315|NCT01519089|Primary|Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 16|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of body surface area (BSA) affected. PASI is a composite scoring assessed by the investigator, of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response was defined as at least a 75 percent (%) reduction in PASI at Week 16 relative to Baseline."|Week 16|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.||Percentage of participants|||Number
684316|NCT01518946|Primary|Time to Onset of Syncope/Near Syncope While on Tilt Table|After a 30-minute supine period, the table was tilted from 0-90º within 30 seconds and maintained in that position for 45 minutes or until endpoint. Subjects were monitored for near-syncopal symptoms (subject felt sufficiently dizzy, lightheaded, faint, or felt like they were about to black out and requested the table to be returned to horizontal). Such a report ended the test. Alternatively, if the investigator observed that the subject was about to lose consciousness, that also constituted an endpoint.|1 hour post-dose|The Full Analysis Set was defined as all randomized subjects who received at least 1 dose of randomized investigational product and who had at least 1 measurement of the time to onset of syncopal symptoms/near syncope during tilt-table testing.||seconds||Standard Error|Least Squares Mean
684321|NCT01518322|Primary|Relationship Between FeNO and the Prescription of ICS in Primary Care Practices|The total number of subjects prescribed Inhaled Corticosteroids (ICS) will be tabulated by Fractional Exhaled Nitric Oxide (FeNO). FeNO is split into high, intermediate and low categories and the associated kappa statistics and 95% confidence intervals are presented. FeNO grouping will be calculated per the American Thoracic Society (ATS) standards. For children under age 12 years, <20 ppb is low, ≥20 ppb and ≤35 ppb is intermediate, and >35 ppb is high. For those aged 12 years or older, <25 ppb is low, ≥25 ppb and ≤50 ppb is intermediate, and >50 ppb is high.|Single-visit, one (1) FeNO measurement. One (1) timepoint (Day 1)|A total of 235 subjects were initially deemed eligible for the study and were identified as the All Subjects Population. Following review of the eligibility criteria and FeNO, 73 subjects were excluded from the Per Protocol Population, predominantly because of their prior asthma and COPD history and missing FeNO values.||participants|||Number
684322|NCT01518322|Primary|Relationship Between FeNO and the Diagnosis of Asthma|For the primary analysis, the total number of subjects diagnosed with asthma is tabulated by Fractional Exhaled Nitric Oxide (FeNO). FeNO is split into high, intermediate and low categories and the associated kappa statistics and 95% confidence intervals are presented. FeNO grouping will be calculated per the American Thoracic Society (ATS) standards. For children under age 12 years, <20 ppb is low, ≥20 ppb and ≤35 ppb is intermediate, and >35 ppb is high. For those aged 12 years or older, <25 ppb is low, ≥25 ppb and ≤50 ppb is intermediate, and >50 ppb is high.|Single-visit, one (1) FeNO measurement. One (1) timepoint (Day 1)|A total of 235 subjects were initially deemed eligible for the study and were identified as the All Subjects Population. Following review of the eligibility criteria and FeNO, 73 subjects were excluded from the Per Protocol Population, predominantly because of their prior asthma and COPD history and missing FeNO values.||participants|||Number
684323|NCT01518270|Secondary|Eyelash Darkness as Measured by Digital Image Analysis (DIA)|Photographs were taken of the Eyelashes. Eyelash darkness (intensity) was measured within the spline (a narrow area approximately 5 pixels wide that bisects the area of interest). Eyelash darkness was measured in both eyes and averaged for analysis using a scale where 0=black and 255=white.|Baseline|All participants with values available.||Units on a scale||Full Range|Mean
684324|NCT01518270|Secondary|Eyelash Thickness as Measured by Digital Image Analysis (DIA)|Photographs were taken of the eyelashes. Eyelash thickness/fullness was assessed across both eyes as an average of the 3 preset areas measured in millimeters squared (mm^2).|Baseline|All participants with values available.||Millimeters squared (mm^2)||Full Range|Mean
684325|NCT01518270|Primary|Eyelash Length as Measured by Digital Image Analysis (DIA)|Photographs were taken of the eyelashes. Length was measured in millimeters. Data from both eyes were averaged for each participant for analysis.|Baseline|All participants with values available.||Millimeters (mm)||Full Range|Mean
684326|NCT01518257|Post-Hoc|Change From Baseline in WOMAC Pain Score in the Nociceptive Pain Group|The WOMAC Pain Score included 5 questions about pain where: 0=no pain to 10=extreme pain for a total possible score of 0 (best) to 50 (worst). A negative change from Baseline indicated improvement.|Baseline, Week 8|Participants from the Safety population (all treated participants based on the actual treatment received) in a subgroup of patients with nociceptive pain (pain that is caused by nerves that react to injury or damage) at Baseline.||Score on a scale||Standard Deviation|Mean
684327|NCT01518257|Post-Hoc|Change From Baseline in the Average Daily Worst Pain Intensity Score in the Nociceptive Pain Group|The patient rated their daily worst pain intensity in the study knee using an 11-point scale where: 0=no pain to 10=worst pain possible. The daily scores over the previous 14-day period were averaged. A negative change from Baseline indicated improvement.|Baseline, Weeks 4, 8 and 12|Participants from the Safety population (all treated participants based on the actual treatment received) in a subgroup of patients with nociceptive pain (pain that is caused by nerves that react to injury or damage) at Baseline.||Score on a scale||Standard Deviation|Mean
684328|NCT01518257|Primary|Change From Baseline in the Average Daily Worst Pain Intensity Score at Week 12|The patient rated their daily worst pain intensity in the study knee using an 11-point scale where: 0=no pain to 10=worst pain possible. The daily scores over the previous 14-day period were averaged. A negative change from Baseline indicated improvement.|Baseline, Week 12|Safety population included all treated participants based on the actual treatment received.||Score on a scale||Standard Deviation|Mean
684329|NCT01518257|Primary|Change From Baseline in the Average Daily Worst Pain Intensity Score at Week 8|The patient rated their daily worst pain intensity in the study knee using an 11-point scale where: 0=no pain to 10=worst pain possible. The daily scores over the previous 14-day period were averaged. A negative change from Baseline indicated improvement.|Baseline, Week 8|Safety population included all treated participants based on the actual treatment received.||Score on a scale||Standard Deviation|Mean
684330|NCT01518257|Secondary|Patient Global Impression of Change Score|The participants rated the change in their health status since enrollment using a 7-point scale where: +3=very much improved, +2=much improved, +1=minimally improved, 0=no change, -1=minimally worse, -2=much worse and -3=very much worse. Negative scores indicated worsening and positive scores indicated improvement.|Week 8|Participants from the Safety population (all treated participants based on the actual treatment received) with data available for this outcome measure.||Score on a scale||Standard Deviation|Mean
684331|NCT01518257|Secondary|Change From Baseline in WOMAC Physical Function Score|The WOMAC Physical Function Score included 17 questions about the difficulty of daily activities where: 0=no difficulty to 10=extreme difficulty for a total possible score of 0 (best) to 170 (worst). A negative change from Baseline indicated improvement.|Baseline, Week 8|Safety population included all treated participants based on the actual treatment received.||Score on a scale||Standard Deviation|Mean
684332|NCT01518257|Secondary|Change From Baseline in WOMAC Pain Score|The WOMAC Pain Score included 5 questions about pain where: 0=no pain to 10=extreme pain for a total possible score of 0 (best) to 50 (worst). A negative change from Baseline indicated improvement.|Baseline, Week 8|Safety population included all treated participants based on the actual treatment received.||Score on a scale||Standard Deviation|Mean
684350|NCT01517984|Secondary|Percentage of Participants With Donor-Specific Memory Using Elispot|This endpoint was unable to be analyzed because the study was terminated early after stopping rules were met.|6 to 18 months post-randomization|No analyses were performed due to early study closure.|||||
684333|NCT01518257|Secondary|Change From Baseline in Western Ontario and McMaster Universities Arthritis (WOMAC™) Total Index Score|The WOMAC Total Index Score consisted of 24 components rated on a scale of 0 to 10. The Total Index Score included the WOMAC Pain Score (5 questions about pain where: 0=no pain to 10=extreme pain), the WOMAC Physical Function score (17 questions about the difficulty of daily activities where: 0=no difficulty to 10=extreme difficulty) and the WOMAC Stiffness Score (2 questions about stiffness where: 0=no stiffness to 10=extreme stiffness) for a total possible Index Score of 0 (best) to 240 (worst). A negative change from Baseline indicated improvement.|Baseline, Week 8|Safety population included all treated participants based on the actual treatment received.||Score on a scale||Standard Deviation|Mean
684334|NCT01518257|Primary|Change From Baseline in the Average Daily Worst Pain Intensity Score at Week 4|The patient rated their daily worst pain intensity in the study knee using an 11-point scale where: 0=no pain to 10=worst pain possible. The daily scores over the previous 14-day period were averaged. A negative change from Baseline indicated improvement.|Baseline, Week 4|Safety population included all treated participants based on the actual treatment received.||Score on a scale||Standard Deviation|Mean
684335|NCT01518244|Secondary|Percentage of Subjects Who Reach Target IOP (≤18 mmHg) at Week 8|IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.|Week 8|The analysis population includes all participants who received AZARGA® and with at least 1 on-therapy study visit (V2 or V3).||percentage of participants|||Number
684336|NCT01518244|Primary|Mean Change in Intraocular Pressure (IOP) From Baseline (Prior Therapy) at Week 8|IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.|Baseline, Week 8|The analysis population includes all participants who received AZARGA® and with at least 1 on-therapy study visit (V2 or V3).||milllimeters mercury (mmHg)||Standard Deviation|Mean
684337|NCT01518192|Secondary|Selected Subjective Symptoms in Patients and Control Subjects|Comparison of the number of patients and controls with selected 8 symptoms (fatigue, arthralgias, myalgias, headache, paresthesias, dizziness, irritability, or nausea) within the preceding week, irrespective of whether they were new or increased since erythema migrans.|Examination at 12 months|all participants who followed the protocol||participants|||Number
684338|NCT01518192|Secondary|New or Increased Symptoms Since Erythema Migrans in Patients Controls at 12 Months.|Comparison of the number of patients and controls with new or increased symptoms since erythema migrans at 12 months.|12 months|all participants who followed the protocol||participants|||Number
684339|NCT01518192|Primary|Objective Lyme Disease Manifestations and Post-Lyme Disease Symptoms at 12 Months|Number of patients with objective Lyme disease manifestations and/or post-Lyme disease symptoms in patients treated for solitary erythema migrans at 12 months post inclusion|12 months|all participants who followed the protocol||participants|||Number
684340|NCT01518192|Primary|Objective Lyme Disease Manifestations and Post-Lyme Disease Symptoms at 6months|Number of patients with objective Lyme disease manifestations and/or post-Lyme disease symptoms in patients treated for solitary erythema migrans at 6 months post inclusion|6 months|all participants who followed the protocol||participants|||Number
684341|NCT01518192|Primary|Objective Lyme Disease Manifestations and Post-Lyme Disease Symptoms at 2 Months|Number of patients with objective Lyme disease manifestations and/or post-Lyme disease symptoms in patients treated for solitary erythema migrans at 2 months post inclusion|2 months|all participants who followed the protocol||participants|||Number
684342|NCT01518192|Primary|Adverse Events|Number of patients reporting adverse events|at 14 days|All participants who followed the protocol.||participants|||Number
684343|NCT01518192|Secondary|New or Increased Symptoms Since Erythema Migrans in Patients and Controls at 6 Months.|Comparison of the number patients and controls with new or increased symptoms since erythema migrans at 6 months.|6 months|all participants who followed the protocol||participants|||Number
684344|NCT01518192|Primary|Objective Lyme Disease Manifestations and Post-Lyme Disease Symptoms at 14 Days|Number of patients with objective manifestations of Lyme disease(persistence of erythema migrans or any of the extracutaneous-cardiac, nervous or skeletal-Lyme disease manifestations)and/or with post-Lyme disease symptoms in patients treated for solitary erythema migrans at 14 days post inclusion|at 14 days post inclusion|All participants who followed the protocol were eligible for analysis||participants|||Number
684345|NCT01518153|Secondary|Overall Survival (OS)|Overall Survival is defined as the interval between day of transplant and day of death.|Every 3 months until day of death|Sixteen participants have been treated on study and were evaluable for treatment response. Out of 16, 7 participants met the criteria to receive planned DLI.||days||Full Range|Median
684346|NCT01518153|Primary|Success Rate|Success rate defined as alive, engrafted without grade 3 or 4 GvHD or relapse at day 100 post allogeneic stem cell transplantation followed by donor lymphocyte infusion (DLI).|100 days|Sixteen participants have been treated on study and were evaluable for treatment response. Out of 16, 7 participants met the criteria to receive planned DLI. 9 participants did not meet the criteria to receive randomized planned DLI.||participants|||Number
684347|NCT01517984|Secondary|Measurement of Urinary Parameters Before and After Randomization|This endpoint was unable to be analyzed because the study was terminated early after stopping rules were met.|6 months post-transplantation to 18 months post-randomization|No analyses were performed due to early study closure.|||||
684348|NCT01517984|Secondary|Incremental Change in IF/TA Scores|This endpoint was unable to be analyzed because the study was terminated early after stopping rules were met.|6 to 18 months post-transplant|No analyses were performed due to early study closure.|||||
684349|NCT01517984|Secondary|Percentage of Participants in the Experimental Arm Off Tacrolimus|Participants in the ‘Randomized to Tacrolimus Withdrawal’ group were considered fully withdrawn once they no longer received any doses of tacrolimus. Participants met this endpoint if they did not resume taking tacrolimus as of 18 months post randomization with stable allograft function and without rejection of donor-specific antibodies.|18 months post-randomization|Intent-to-treat||percentage of participants|||Number
684354|NCT01517984|Secondary|Incidence of Acute Rejection|Acute renal allograft rejection is defined as histological reading of borderline or greater determined by the local pathology laboratory. Participants suspected of having a rejection episode on the basis of clinical signs, symptoms, or on the basis of laboratory tests, had a renal ultrasound and underwent a renal transplant biopsy. Any detection of acute cellular rejection or acute humoral rejection resulted in participants in the ‘Randomized to Tacrolimus Withdrawal’ group to be restarted on tacrolimus and followed per the reduced follow-up schedule of events.|6 to 18 months post-randomization|Intent-to-treat||participants|||Number
684355|NCT01517984|Secondary|Estimated GFR Using the Chronic Kidney Disease Epidemiology (CKD-EPI) Equation|Estimated glomerular filtration rate (eGFR) is a test to measure the level of kidney function. In this measure, the effects of tacrolimus withdrawal on long-term kidney function was assessed by comparing absolute 24 month eGFR (18 months post-randomization) and change in eGFR from 6 to 24 months (randomization to 18 months randomization). Lower numbers indicate poorer kidney function|6 months post-transplantation, 24 months post-transplantation|Intent-to-treat||mL/min||Standard Deviation|Mean
684356|NCT01517984|Primary|Percentage of Participants With Incremental IF/A Scores >2 at 24 Months Post-Randomization|The investigators were not able to assess this outcome, the effect of the intervention on interstitial fibrosis/tubular atrophy (IF/TA; on a 2-year graft biopsy) due to the study's premature termination by the Data Safety Monitoring Board (DSMB) because of absence of equipoise on the basis of predetermined stopping rules.|IF/TA scores on protocol biopsies obtained at 24 months post-randomization will be compared to those obtained at the time of implantation for this measurement.|No analyses were performed due to early study closure.|||||
684357|NCT01517893|Secondary|Decrease in Serum Chemokines|Determination of the effects of simvastatin treatment on multiple chemokines in the blood of patients with vitiligo treated with simvastatin versus placebo|Assessed prior to treatment and periodically while on treatment||||||
684358|NCT01517893|Secondary|Correlation Among Various Outcome Measures for Vitiligo|Comparison of all tested outcome measures to identify the level of correlation among them, including VASI, Sentinel Patch, Investigator's Global Assessment Score, and Patient's Global Assessment Score|Assessed at final study visit, 6 months after randomization||||||
684359|NCT01517893|Secondary|Increase in Patient's Global Assessment Score|Increase in Patient's Global Assessment Scores of 30% or more from baseline to last available visit|Assessed at final study visit, 6 months after randomization||||||
684360|NCT01517893|Secondary|Decrease in CXCR3 Expression on CD8+ T Cells|Determination of the effects of simvastatin treatment on CXCR3 expression in melanocyte-specific, autoreactive CD8+ T cells in the blood of patients with vitiligo treated with simvastatin versus placebo|Assessed prior to treatment and periodically while on treatment||||||
684361|NCT01517893|Secondary|Increase in Quality of Life (QoL) Score|Increased quality of life based on end of study questionnaire scores of subjects randomized to treatment with simvastatin versus placebo|Assessed at final study visit, 6 months after randomization||||||
684362|NCT01517893|Secondary|Decrease in Sentinel Patch Area|Decrease in percent depigmentation of sentinel patch lesion from baseline to last available study visit.|Assessed at final study visit, 6 months after randomization||||||
684363|NCT01517893|Secondary|Safety and Tolerability of High-dose Simvastatin Use in Vitiligo Patients.|Monitoring lab values and patient symptoms for evidence of simvastatin toxicity|Assessed at every visit following randomization (monthly for 6 months)||||||
684364|NCT01517893|Secondary|Increase in Investigator's Global Assessment Score|Increase in Investigator Global Assessment Scores of 30% or more from baseline to last available visit|Assessed at final study visit, 6 months after randomization||||||
684365|NCT01517893|Primary|Decrease in VASI Score|Number of participants with 33% decrease in the Vitiligo Area Scoring Index (VASI) from baseline to the last available study visit|Assessed at final study visit, 6 months after randomization|||participants|||Number
684366|NCT01517750|Post-Hoc|Adherence With ENT Surgeries||6 weeks after randomization|||mins||Standard Deviation|Mean
684367|NCT01517750|Post-Hoc|Outcomes in Patients With ENT (Ears, Nose and Throat) Surgeries||6 weeks after randomization|||units on a scale||Standard Deviation|Mean
684368|NCT01517750|Secondary|Nasopharyngeal Complaints|"Nasopharyngeal complaints (NPC) were assessed by a questionnaire. Subjects were asked to evaluate their condition on a scale from 0 (“no complaints”) to 5 (“very strong). The following questions were asked within the questionnaire: Did you observe nasal congestion, nasal dryness, runny nose, dry mouth, and dry throat (0-5 each) during the last week. The maximal achievable sum score was 25."|6 weeks after patient randomization|||units on a scale||Standard Deviation|Mean
684369|NCT01517750|Secondary|Functional Outcome of Sleep Questionnaire (FOSQ)|"FOSQ is a measure of the impact of the disorder on multiple activities with everyday living and how the treatment can improve these activities. There are 30 questions and for each questions you have to pick from a subscale from 0-4; 0 = I don't do this activity for other reasons, 1=Yes extremely, 2=Yes moderately, 3= Yes a little, 4 = No. Scores of each subscale will be summed up and scaled to a maximum achievable value of 20. The sum score was calculated. The value range is 0-100. A higher score means that the treatment has positively improved everyday activities."|6 weeks after patient randomization|||units on a scale||Standard Deviation|Mean
684370|NCT01517750|Secondary|Epworth Sleepiness Score (ESS)|The ESS is a measure of daytime sleepiness and has a total of 24 points. A range from 0-9 is considered normal. A score of more than 9 is considered to have abnormal daytime sleepiness|6 weeks after patient randomization|||units on a scale||Standard Deviation|Mean
684371|NCT01517750|Primary|Therapy Adherence With Treatment Per Night Averaged Over Total Time Period Measured Via Internal Software on the Device and Reported on Using InfoSmart™ Software With and Without Heated Humidification.||6 weeks after patient randomization|||minutes||Standard Deviation|Mean
684372|NCT01517529|Secondary|Number of Participants Who Cleared the Virus|Blood samples will be drawn while the subject is on treatment to measure viral load and HCV-specific immune responses|9 months|||participants|||Number
684373|NCT01517529|Primary|Number of Participants Who Completed Standard Treatment|Blood samples will be drawn while the subject is on treatment to measure viral load and HCV-specific immune responses.|9 months|Measure HCV viral load and HCV-specific immune responses at baseline||participants|||Number
684374|NCT01517412|Secondary|Change in Diabetes Treatment Satisfaction Questionnaire Score (DTSQs) From Baseline to Week 24|DTSQ is a validated measure to assess how satisfied participants with diabetes are with their treatment and how they perceive hyper­ and hypoglycemia. It consists of 8 questions which are answered on a Likert scale from 0 to 6. DTSQ treatment satisfaction score is the sum of question 1, 4, 5, 6, 7 and 8 scores and ranges between 0 and 36, where higher scores indicate more treatment satisfaction. On-treatment period for treatment satisfaction assessment was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug. Missing data was imputed using LOCF. Here, number of participants analyzed = participants with both baseline and Week 24 DTSQ score assessment during on-treatment period.|Baseline, Week 24|mITT population.||Units on a scale||Standard Error|Least Squares Mean
684375|NCT01517412|Secondary|Percentage of Participants Who Reached the Target of HbA1c <7% And Had a 2-hour Postprandial Plasma Glucose (PPG) <140mg/dL After Breakfast or Main Meal At Week 24|On-treatment period for 2-hour PPG assessment was defined as the time from the first dose of study drug up to the day of last dose of study drug. Participants without post-baseline on-treatment values (for HbA1c and 2-hour PPG) that were no more than 30-days apart were counted as non-responders if at least one of the components (HbA1cand/or 2-hour PPG) was available and showed no response. Otherwise, they were counted as missing.|Week 24|mITT population.||Percentage of participants|||Number
684376|NCT01517412|Secondary|Percentage of Participants Who Reached the Target of HbA1c <7% And Had No Body Weight Gain at Week 24 And Did Not Experience Confirmed Symptomatic Hypoglycemia (PG<60 mg/dL [3.3 mmol/L]) During the 24-Week Treatment Period|Participants without post-baseline on-treatment values (for HbA1c and body weight) that were no more than 30 days apart not more than 30-days apart were counted as non-responders if at least one of components (HbA1c and/or body weight) was available and showed no response. Otherwise, they were counted as missing.|Week 24|mITT population.||Percentage of participants|||Number
684377|NCT01517412|Secondary|Percentage of Participants Who Reached the Target of HbA1c <7% And Had No Body Weight Gain at Week 24|Participants without post-baseline on-treatment values for (HbA1c and body weight) that were no more than 30 days apart were counted as non-responders if at least one of the components (HbA1c and/or body weight) was available and showed no response. Otherwise, they were counted as missing.|Week 24|mITT population.||Percentage of participants|||Number
684378|NCT01517412|Secondary|Percentage of Participants Who Reached the Target of HbA1c <7% at Week 24 And Did Not Experience Confirmed Symptomatic Hypoglycemia (Plasma Glucose [PG] <60 mg/dL [3.3 mmol/L]) During 24-Week Treatment Period|Symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemic episode with an accompanying PG<60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate if no PG measurement was available. On-treatment period for symptomatic hypoglycemia assessment was defined as time from first dose of study drug up to 1 day after last dose of study drug. Participants without any post-baseline on-treatment value for HbA1c were counted as non-responders if they experienced at least one symptomatic hypoglycemia. Otherwise, they were counted as missing.|Week 24|mITT population.||Percentage of participants|||Number
684379|NCT01517412|Secondary|Change in Body Weight From Baseline to Week 24|Change in body weight was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug. Here, number of participants analyzed = participants with baseline and at least one post-baseline body weight assessment during on-treatment period.|Baseline, Week 24|mITT population.||kg||Standard Error|Least Squares Mean
684380|NCT01517412|Secondary|Change in FPG From Baseline to Week 24|Change in FPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to 1 day after the last dose of study drug. Here, number of participants analyzed = participants with baseline and at least one post-baseline FPG assessment during on-treatment period.|Baseline, Week 24|mITT population.||mmol/L||Standard Error|Least Squares Mean
684381|NCT01517412|Secondary|Change in Average 7-point SMPG Profiles From Baseline to Week 24|Participants recorded a 7-point plasma glucose profile measured before and 2 hours after each meal and at bedtime two times in a week before baseline, before visit Week 8, before visit Week 12 and before visit week 24. The average value across the profiles performed in the week a visit for the 7-time points was calculated. Change in average 7-point SMPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to the day of last dose of study drug. Here, number of participants analyzed = participants with baseline and at least one post-baseline 7-point SMPG assessment during on-treatment period.|Baseline, Week 24|mITT population.||mmol/L||Standard Error|Least Squares Mean
684382|NCT01517412|Secondary|Percentage of Participants With HbA1c Level <7 % or ≤6.5% at Week 24|Here, number of participants analyzed = participants with baseline and at least one post-baseline HbA1c assessment during on-treatment period.|Week 24|mITT population.||Percentage of participants|||Number
684383|NCT01517412|Primary|Change in HbA1c From Baseline to Week 24|Change in HbA1C was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using last observation carried forward (LOCF). On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. Here, number of participants analyzed = participants with baseline and at least one post-baseline HbA1c assessment during on-treatment period.|Baseline, Week 24|Modified intent-to-treat (mITT) population: all randomized participants who received at least one dose of study drug and had both baseline and at least one post-baseline assessment of any primary or secondary efficacy endpoints, irrespective of compliance with study protocol and procedures.||Percentage of hemoglobin||Standard Error|Least Squares Mean
684394|NCT01517373|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 2, 4, 6 and 8|HbA1c is a form of hemoglobin which is measured primarily to identify the average glycemic control over prolonged periods of time. The normal range for the HbA1c test, was identified as less than 6.5 percent by the study-specific central laboratory used. Change from baseline in percentage of HbA1C was reported.|Baseline (Day 1), Week 2, 4, 6, 8|FAS: All randomized participants who received at least 1 dose of study treatment. Here, ‘N’ signifies participants for whom data was summarized for this measure and ‘n’ signifies participants who were evaluable at given time points for each group. Data for Week 2 had not been reported because as per protocol it was not intended to be collected.||percentage of hemoglobin||Standard Deviation|Mean
684384|NCT01517373|Secondary|Number of Participants With Abnormal Laboratory Values|Hemoglobin,hematocrit,red blood cells(RBC) count:less than [<]0.8*lower limit of normal [LLN],platelets:<0.5*LLN/greater than [>]1.75*upper limit of normal [ULN],white blood cells(WBC):<0.6*LLN or >1.5*ULN,lymphocytes,total neutrophils:<0.8*LLN or >1.2*ULN, basophils,eosinophil,monocytes:>1.2*ULN;aspartate aminotransferase,alanine aminotransferase, alkaline phosphatase:>0.3*ULN,total protein,albumin:<0.8*LLN or >1.2*ULN;total bilirubin,direct bilirubin,indirect bilirubin:>1.5*ULN;triglycerides,cholesterol:>1.3*ULN, HDL:<0.8*LLN, LDL:>1.2*ULN,blood urea nitrogen,creatinine:>1.3*ULN,uric acid:>1.2*ULN;sodium: <0.95*LLN or >1.05*ULN,potassium,chloride,calcium,bicarbonate:<0.9*LLN or >1.1*ULN;creatine kinase:>2.0*ULN;glucose:<0.6*LLN or >1.5*ULN,urine WBC and RBC:>= 20/High Power Field [HPF]),urine epithelial cells (>=1 HPF),urine bacteria >20 high-powered field;qualitative urine glucose,urine blood to Hgb ratio (>=1);urine(protein,nitrite,mucus,leukocyte >=1 in urine dipstick test).|Baseline (Day 1) up to Week 14|Safety analysis set included all randomized participants who received at least 1 dose of study treatment. Here, 'N' (number of participants analyzed) signifies participants for whom data was summarized for this measure||participants|||Number
684385|NCT01517373|Secondary|Change From Baseline in Body Weight at Week 2, 4, 6, 8, 12 and 14||Baseline (Day 1), Week 2, 4, 6, 8, 12, 14 (follow-up)|Safety analysis set included all randomized participants who received at least 1 dose of study treatment. Here, 'N' (number of participants analyzed) signifies participants for whom data was summarized for this measure and 'n' signifies participants evaluable at given time points for each group.||kilogram (kg)||Standard Deviation|Mean
684386|NCT01517373|Secondary|Time to Each Recurrent Hypoglycemic Events (HAE) Episode Per Participant|Median recurrence time was not to be calculated when less than 50% of the participants in a given arm experienced 1 or more HAEs.|Baseline (Day 1) up to Week 14|Data was not collected since this outcome measure was not analyzed due to infrequency of the occurrence of HAEs among the participants.|||||
684387|NCT01517373|Secondary|Number of Hypoglycemic Events (HAE) Episodes Per Participant|A hypoglycemic event was identified by characteristic symptoms or blood glucose levels. Median of 1 and 2 events per participant was reported.|Baseline (Day 1) up to Week 14|Safety analysis set included all randomized participants who received at least 1 dose of study treatment.||events per participant||Full Range|Median
684388|NCT01517373|Secondary|Percentage of Participants With at Least 1 Hypoglycemic Events (HAE) Episode|A hypoglycemic event was identified by characteristic symptoms or blood glucose levels. HAE was defined as 1 of the given definitions: Characteristic symptoms of HAE with no home glucose monitoring performed where clinical picture included prompt resolution with food intake, subcutaneous glucagon, or intravenous glucose; or characteristic symptoms of HAE with home glucose monitoring measurement =< 70 milligram per deciliter (mg/dL) using ACCU-CHEK plasma-referenced home glucometers or =<74 mg/dL using International Federation of Clinical Chemistry (IFCC) referenced ACCU-CHEK or central laboratory glucometers; or any laboratory glucose value, meeting the following criterion with or without accompanying symptoms: =<49 mg/dL using ACCU-CHEK plasma-referenced home glucometers or =<53 mg/dL using IFCC referenced ACCU-CHEK or central laboratory glucometers.|Baseline (Day 1) up to Week 14|Safety analysis set included all randomized participants who received at least 1 dose of study treatment.||percentage of participants|||Number
684389|NCT01517373|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 14 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.|Baseline (Day 1) up to 14 days after last dose of study treatment (up to 101 days)|Safety analysis set included all randomized participants who received at least 1 dose of study treatment.||participants|||Number
684390|NCT01517373|Secondary|Number of Participants With Increase/Decrease From Baseline Vital Signs Data|Participants who met the criteria for increase or decrease in vital signs data were reported. Criteria for increase or decrease from baseline vital signs data: sitting systolic blood pressure (BP) of >=30 millimeter of mercury (mmHg); sitting diastolic BP of >=20 mmHg and pulse rate was based on investigator’s discretion.|Baseline (Day 1) up to Week 14|Safety analysis set included all randomized participants who received at least 1 dose of study treatment. Here, 'N' (number of participants analyzed) signifies participants for whom data was summarized for this measure||participants|||Number
684391|NCT01517373|Secondary|Number of Participants With Increase From Baseline Electrocardiogram (ECG) Data|Participants who met the criteria for increase from baseline in ECG data were reported. Criteria for increase from baseline data: PR interval (percent change of greater than or equal to [>=] 25/50% [if baseline value was >200 then percent change of >25% counts; if baseline value was <=200 then percent change of >50% counts]); QRS complex (percent change of >=50%); QT Fridericia’s correction (QTcF) interval (change of >= 30 to <60 millisecond [msec], and change of >=60 msec).|Baseline (Day 1) up to Week 14|Safety analysis set included all randomized participants who received at least 1 dose of study treatment. N(number of participants analyzed)= participants who were evaluable for this measure.||participants|||Number
684392|NCT01517373|Secondary|Percentage of Participants Achieving Less Than 6.5 Percent and Less Than 7 Percent Glycosylated Hemoglobin (HbA1c) Levels at Week 12|HbA1c is a form of hemoglobin which is measured primarily to identify the average glycemic control over prolonged periods of time. The normal range for the HbA1c test, was identified as less than 6.5 percent by the study-specific central laboratory used and data are presented in categories of less than 6.5 percent and less than 7 percent.|Week 12|FAS included all randomized participants who received at least 1 dose of study treatment. Here, 'N' (number of participants analyzed) signifies participants for whom data was summarized for this measure.||percentage of participants|||Number
684393|NCT01517373|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 2, 4, 6, 8 and 12||Baseline (Day 1), Week 2, 4, 6, 8, 12|FAS included all randomized participants who received at least 1 dose of study treatment. Here, 'N' (number of participants analyzed) signifies participants for whom data was summarized for this measure and 'n' signifies participants evaluable at given time points for each group.||milligram per deciliter (mg/dL)||Standard Deviation|Mean
684395|NCT01517373|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 12|HbA1c is a form of hemoglobin which is measured primarily to identify the average glycemic control over prolonged periods of time. The normal range for the HbA1c test, was identified as less than 6.5 percent by the study-specific central laboratory used. Change from baseline in percentage of HbA1C was reported.|Baseline (Day 1), Week 12|Full analysis set (FAS) included all randomized participants who received at least 1 dose of study treatment. Here, 'N' (number of participants analyzed) signifies participants for whom data was summarized for this measure and 'n' signifies participants evaluable at given time points for each group.||percentage of hemoglobin||Standard Deviation|Mean
684396|NCT01517295|Secondary|Peak Urine Concentration of Hydromorphone|Analyze the urine concentration of hydromorphone|Up to 4 hours|||ng/mL||Standard Deviation|Mean
684397|NCT01517295|Secondary|Correlation of Plasma PK of Hydrocodone|Correlate the plasma pharmacokinetic profile of hydromorphone to their hydrocodone doses.|1 Month|Analysis could not be performed because plasma levels analyzed were too low for the assay chosen.|||||
684398|NCT01517295|Primary|Peak Plasma Concentration of Hydromorphone|Determine the plasma pharmacokinetic profile of hydromorphone in chronic pain subjects taking hydrocodone within a 6 hour time frame. Note: Sensitivity of the lab test used to determine plasma hydromorphone concentrations was not sufficient. Failure to meet the lowest level of detection, all subjects plasma hydromorphone concentrations were recorded as zero at all time points.|Up to 6 hours|||ng/mL||Standard Deviation|Mean
684399|NCT01517282|Secondary|Number of New or Enlarging T2 Lesions|T2-weighted magnetic resonance imaging (MRI) tests were performed at Weeks 8, 12, and 16 to assess the number of new or enlarging T2 brain lesions, a sign of MS activity. MRI images were assessed centrally by Synarc A/S (Hamburg, Germany).|Week 8, week 12, and week 16.|"MRIs were performed in the safety population (all patients who received at least 1 dose of MOR103 or placebo). However, MRIs at Weeks 12 and 16 were not mandatory per protocol. The number of patients evaluated at Weeks 8, 12, and 16 were:
MOR103 0.5 mg/kg: 8,8,8 MOR103 1.0 m/kg: 6,6,6 MOR103 2.0 mg/kg: 7,7,7 Placebo: 6, 4, 5"||Number of new or enlarging T2 lesions|||Number
684400|NCT01517282|Secondary|Number of New T1 Gadolinium-enhancing Lesions|Magnetic resonance imaging (MRI) tests were performed at screening (to confirm subject eligibility) and at Weeks 4, 8, 2, and 16. MRIs at post-screening time points were used to assess the number of new lesions as revealed by gadolinium (Gd) enhancement. Gd-enhanced MRIs reveal new brain lesions reflecting areas of active inflammation. MRI images were assessed centrally by Synarc A/S (Hamburg, Germany).|Week 4, week 8, week 12, and week 16.|"MRIs were performed in the safety population (all patients who received at least 1 dose of MOR103 or placebo). However, MRIs at Weeks 12 and 16 were not mandatory per protocol. The number of patients evaluated at Weeks 4, 8, 12, and 16 were:
MOR103 0.5 mg/kg: 8,8,8,8 MOR103 1.0 m/kg: 6,6,6,6 MOR103 2.0 mg/kg: 8,7,7,7 Placebo: 6, 6, 4, 5"||Number of new T1 Gd-enhancing lesions|||Number
684401|NCT01517282|Secondary|Accumulation Ratio for Area Under the MOR103 Serum Concentration Versus Time Curve (AUC) Over One Dosing Interval: Ratio of Week 10 (Last Dose) AUC to Week 0 (First Dose) AUC|At week 0 (first dose) and week 10 (last dose), serum samples were obtained at pre-dose and at 1, 2, 4, and 336 hours after start of dosing. To calculate the accumulation ratio, the apparent AUC calculated for the last dose was divided by the apparent AUC following the first dose using the described time points for each dosing. Because AUC is a summary outcome, only one value is presented for each dose cohort on each day; values at each PK time point are not applicable.|Week 0 (first dose) and week 10 (last dose)|Pharmocokinetic (PK) analyses were conducted on the PK set, which included all MOR103-treated patients except for 2 patients who discontinued after 2 doses of trial medication (one each in the 1.0 and 2.0 mg/kg groups). Data were missing for one patient in the MOR103 2.0 mg/kg group (n = 7).||ratio of AUC values||Standard Deviation|Mean
684402|NCT01517282|Secondary|Mean Time to Maximum MOR103 Concentration (Tmax) After the First and Last MOR103 Doses|At the week 0 (first dose) and week 10 (last dose) visits, serum samples were obtained at pre-dose and at 1, 2, and 4 hours after the dose. Tmax values for each patient were calculated based on these data, and the mean Tmax values for the dose cohort are presented here. Because Tmax refers to the time to maximum serum concentration, only one value is presented for each dose cohort on each day; values at each PK time point are not applicable.|Week 0 (first dose) and week 10 (last dose)|Pharmocokinetic (PK) analyses were conducted on the PK set, which included all MOR103-treated patients except for 2 patients who discontinued after 2 doses of trial medication (one each in the 1.0 and 2.0 mg/kg groups). PK data for the last dose were missing for one patient in the MOR103 2.0 mg/kg group (n = 7).||hour||Standard Deviation|Mean
684403|NCT01517282|Secondary|Mean Maximum MOR103 Concentration (Cmax) After the First and Last MOR103 Doses|At the week 0 (first dose) and week 10 (last dose) visits, serum samples were obtained at pre-dose and at 1, 2, and 4 hours after the dose. Cmax values for each patient were calculated based on these data, and the mean Cmax values for the dose cohort are presented here. Because Cmax refers to the maximum serum concentration, only one value is presented for each dose cohort on each day; values at each PK time point are not applicable, as they represent the concentration of MOR103, but not the Cmax.|Week 0 (first dose) and week 10 (last dose)|Pharmocokinetic (PK) analyses were conducted on the PK set, which included all MOR103-treated patients except for 2 patients who discontinued after 2 doses of trial medication (one each in the 1.0 and 2.0 mg/kg groups). PK data for the last dose were missing for one patient in the MOR103 2.0 mg/kg group (n = 7).||mg/L||Standard Deviation|Mean
684404|NCT01517282|Secondary|Mean Serum Concentration of MOR103 Over Time|MOR103 serum levels were measured at each visit. At all visits during the dosing period (weeks 0, 2, 6, 8, and 10), serum samples were taken before MOR103 administration (pre-dose) and 1 hour after the dose. In addition, at week 0 (first dose) and week 10 (last dose), additional samples were obtained at 2 hours and 4 hours after MOR103 administration. At visits that followed the dosing period (weeks 12, 14, 16, and 20), a single serum sample was obtained at any time during the visit.|Week 0 (dose 1) to week 20 (end of study)|Pharmacokinetic (PK) analyses were conducted on the PK set, which included all MOR103-treated patients except for 2 patients who discontinued after 2 doses of trial medication (one each in the 1.0 and 2.0 mg/kg groups). PK data were not available for all patients at each time point.||mg/L||Standard Deviation|Mean
684438|NCT01516879|Secondary|Percent Change From Baseline in LDL-C at Week 12|Cholesterol was measured by means of ultracentrifugation.|Baseline and Week 12|Full Analysis set||percent change||Standard Error|Least Squares Mean
684439|NCT01516879|Secondary|Percentage of Participants With an LDL-C Response at Week 52|An LDL-C response is defined as LDL-C level < 70 mg/dL (1.8 mmol/L) at Week 52.|Week 52|Full Analysis Set||percentage of participants||95% Confidence Interval|Number
684405|NCT01517282|Secondary|Percentages of Patients Negative for Anti-MOR103 Antibodies in Serum Samples|To assess the potential immunogenicity of MOR103, a central bioanalytical laboratory (Eurofins Medinet BV, Breda, The Netherlands) tested serum samples obtained at baseline and at 3 post-treatment time points (week 14, week 16, and week 20/end of study) for anti-MOR103 antibodies.|Baseline, week 14, week 16, and week 20/end of study|All subjects who received 1 or more dose of placebo or MOR103 (safety population). Data were missing for 1 patient each in the MOR103 1.0 mg/kg and 2.0 mg/kg groups at week 14 and week 16. Data were also missing for 1 patient in the placebo group at all post-baseline timepoints (week 14, 16, and 20).||percentage of participants|||Number
684406|NCT01517282|Primary|Percentages of Patients With Treatment-emergent Adverse Events (TEAEs) or Treatment-emergent Serious Adverse Events (TESAEs)|The safety of multiple doses of MOR103 in patients with relapsing-remitting or secondary progressive multiple sclerosis (MS) was assessed by evaluation of the incidence of TEAEs and TESAEs. A full listing of adverse events recorded during this trial can be found in the Adverse Events section. AEs were regarded as treatment emergent if they started on or after the first date of study drug administration or if they were present prior to the first date of study drug administration and increased in severity or relationship to study drug during the study. AEs were coded using MedDRA version 16.1|From the first dose (week 0) to study endpoint (week 20)|All subjects who received 1 or more dose of placebo or MOR103 (safety population).||percentage of participants|||Number
684407|NCT01517178|Primary|Degree of Output Under the Base Plate (Leakage).|Degree of output is measured by a 24-point leakage assessment scale (0 indicating no leakage and 24 indicating maximum leakage).|Each test product was assessed for 2 weeks.|||units on a scale|Participants|Standard Deviation|Mean
684408|NCT01517074|Secondary|Step Changes in Scleral Inflammation According to the Standardized Photographic Grading System Developed at National Eye Institute (NEI)||Baseline and Week 52||||||
684409|NCT01517074|Secondary|Number of Participants Who Experience a Substantial Rise in Elevated Intraocular Pressure (IOP)|A substantial rise in intraocular pressure can be defined as ≥10 mmHg change in pressure.|Baseline and Week 52|||participants|||Number
684410|NCT01517074|Secondary|Proportion of Participants With Loss of ≥ 15 Early Treatment Diabetic Retinopathy Study (ETDRS) Letters|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 52||||||
684411|NCT01517074|Secondary|Number of Participants Who Tapered Off One or More Systemic Immunosuppressive Medications or Tapered Off Prednisone (≤10 mg) After Week 16|Four (4) out of 5 participants were on immunosuppressive medications at enrollment.|Week 16 and Week 52|||participants|||Number
684412|NCT01517074|Secondary|Number of Participants Who Experienced Systemic Toxicities||Baseline and Week 52|||participants|||Number
684413|NCT01517074|Secondary|Number of Participants Who Experienced Ocular Toxicities||Baseline and Week 52|||participants|||Number
684414|NCT01517074|Secondary|Mean Number of Days Between the First Injection to the Second Injection|For participants who demonstrate active inflammation (incomplete or no response to initial injection) or experience a flare-up (as defined by a ≥1-step increase in scleral inflammation) after the initial injection|Baseline and Week 52|||Days||Full Range|Mean
684415|NCT01517074|Secondary|Number of Participants Needing a Second Injection|Participants that still demonstrate active inflammation (incomplete or no response to initial injection) or experience a flare-up (as defined by a ≥1-step increase in scleral inflammation) after the initial injection will be eligible for a re-injection in the study eye at or after Week 4 (not to exceed a dose of 1,320 μg per eye within an eight-week period).|Baseline and Week 52|||participants|||Number
684416|NCT01517074|Secondary|Median Change in Visual Acuity Via the Early Treatment Diabetic Retinopathy Study (ETDRS)|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 52||||||
684417|NCT01517074|Secondary|Mean Change in Visual Acuity Via the Early Treatment Diabetic Retinopathy Study (ETDRS)|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 52||||||
684418|NCT01517074|Secondary|Number of Participants Who Experience a Disease Flare as Defined by a ≥ 1-step Increase in Scleral Inflammation|Scleral inflammation was graded following 10% Phenylephrine application with an ordinal scale of 0 (no scleral inflammation with complete blanching of vessels), 0.5+ (minimal/trace inflammation with localized pink appearance of the sclera around minimally dilated deep episcleral vessels), 1+ (mild inflammation with diffuse pink appearance of the sclera around mildly dilated deep episcleral vessels), 2+ (moderate inflammation with purplish pink appearance of the sclera with tortuous and engorged deep episcleral vessels), 3+ (severe inflammation with diffuse significant redness of sclera, the details of superficial and deep episcleral vessels can’t be observed), and 4+ (necrotizing inflammation with diffuse redness of the sclera with scleral thinning and uveal show)|Baseline and Week 52|||participants|||Number
684419|NCT01517074|Primary|Number of Participants Who Experience at Least 2-step Reduction or Reduction to Grade 0 of Scleral Inflammation in the Study Eye According to the National Eye Institute (NEI) Photographic Scleritis Grading System Within 8 Weeks Post-injection.|"The primary efficacy outcome was a 2-step reduction in scleritis grading out of a scale of 0 to 4+ (where 0.5+ is recognized as an ordinal step between 1+ and 0+).
Scleral inflammation was graded following 10% Phenylephrine application with an ordinal scale of 0 (no scleral inflammation with complete blanching of vessels), 0.5+ (minimal/trace inflammation with localized pink appearance of the sclera around minimally dilated deep episcleral vessels), 1+ (mild inflammation with diffuse pink appearance of the sclera around mildly dilated deep episcleral vessels), 2+ (moderate inflammation with purplish pink appearance of the sclera with tortuous and engorged deep episcleral vessels), 3+ (severe inflammation with diffuse significant redness of sclera, the details of superficial and deep episcleral vessels can’t be observed), and 4+ (necrotizing inflammation with diffuse redness of the sclera with scleral thinning and uveal show)."|Baseline and Week 8|||participants|||Number
684420|NCT01516970|Secondary|Percentage of Participants Who Developed Detectable HIV Antibodies|Seroconversion rate of HIV antibodies while receiving HIV PEP evaluated as the percentage of participants who developed detectable HIV antibodies (defined as positive) and percentage of participants who had not developed detectable HIV antibodies (defined as negative). Per protocol (PP) population included all participants in mITT (defined as all participants who were assigned to receive randomized HIV PEP and were not discontinued due to confirmation of the negative HIV infection status of the index person) excluding participants with: No indication for HIV PEP; Initiation of PEP >72 hours after injury; Discontinuation of HIV PEP due to confirmation of HIV negative status of index person and if index person bears resistant virus against HIV PEP components prescribed; incorrect HIV PEP; no intake of medication.|At Month 3|Analysis was performed on PP population. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||percentage of participants|||Number
684421|NCT01516970|Secondary|Worst Sheehan Disability Scale (SDS) Score for the Safety Population|The Sheehan Disability Scale (SDS) assesses functional impairment in 3 inter-related domains: work/school, social and family life, using a rating scale for each item ranging from 0 (not at all) to 10 (extremely).|Month 3|The safety population included all participants who received at least 1 dose of randomized HIV PEP.||units on a scale||Standard Deviation|Mean
684422|NCT01516970|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|An adverse event (AE) is defined to be non-treatment-emergent if the onset date of the AE was clearly before the date of first HIV PEP administration, otherwise it is considered treatment-emergent.|Up to Month 3|The safety population included all participants who received at least 1 dose of randomized HIV PEP.||participants|||Number
684423|NCT01516970|Primary|Number of Participants With Early Discontinuation From Randomized Human Immunodeficiency Virus Postexposure Prophylaxis (HIV PEP)|Number of participants with early discontinuation from randomized HIV PEP for any reason other than confirmation of the negative HIV infection status of the index person in participants receiving HIV PEP for at least 28 days and a maximum of 30 days was assessed. Per protocol (PP) population included all participants in modified intention-to-treat (mITT [defined as all participants who were assigned to receive randomized HIV PEP and were not discontinued due to confirmation of the negative HIV infection status of the index person]) excluding participants with: No indication for HIV PEP; Initiation of PEP >72 hours after injury; Discontinuation of HIV PEP due to confirmation of HIV negative status of index person and if index person bears resistant virus against HIV PEP components prescribed; incorrect HIV PEP; no intake of medication.|Up to 30 days|Analysis was performed on PP population.||participants||95% Confidence Interval|Number
684424|NCT01516892|Secondary|Change From Baseline in Headache Impact Test Questionnaire (HIT-6) Total Score|The HIT-6 measures the impact of headache and treatment on the participant’s functional health and well-being in 6 domains: pain; role functioning (ability to carry out usual activities); social functioning; energy or fatigue; cognition; and emotional distress assessed over the prior 4-week period. The total possible score ranges from 36 (no impact) to 78 (worst impact). A negative change from Baseline indicates an improvement, and a positive change from Baseline indicates a worsening.|Baseline, Week 60, Week 108|Participants from the Analysis Population, all enrolled participants who had at least one efficacy assessment at baseline or a post-baseline visit, with data available for analysis.||score on a scale||Standard Deviation|Mean
684425|NCT01516892|Secondary|Change From Baseline in the Frequency of Headache Days|Mean change from Baseline in frequency (number) of headache days during the 28 day period ending with Week 60. A headache day was defined as a day (00:00 to 23:59) for which the participant reported a headache in the patient diary with 4 or more continuous hours of headache. A negative change from Baseline indicates improvement.|Baseline, Week 60|Analysis Population included all enrolled participants who had at least one efficacy assessment at baseline or a post-baseline visit.||headache days||Standard Deviation|Mean
684426|NCT01516892|Primary|Change From Baseline in the Frequency of Headache Days|Mean change from Baseline in frequency (number) of headache days during the 28 day period ending with Week 108. A headache day was defined as a day (00:00 to 23:59) for which the participant reported a headache in the patient diary with 4 or more continuous hours of headache. A negative change from Baseline indicates improvement.|Baseline, Week 108|Analysis Population included all enrolled participants who had at least one efficacy assessment at baseline or a post-baseline visit.||headache days||Standard Deviation|Mean
684427|NCT01516879|Secondary|Percent Change From Week 12 to Week 52 in LDL-C|Cholesterol was measured by means of ultracentrifugation.|Week 12 and Week 52|The Effect Durability Analysis Set included participants in the FAS who adhered to the scheduled study drug and had nonmissing LDL-C values at Baseline, Week 12 and Week 52.||percent change||Standard Error|Least Squares Mean
684428|NCT01516879|Secondary|Percent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C) at Week 52|Cholesterol was measured by means of ultracentrifugation.|Baseline and Week 52|Full Analysis Set||percent change||Standard Error|Least Squares Mean
684429|NCT01516879|Secondary|Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Week 52||Baseline and Week 52|Full Analysis Set||percent change||Standard Error|Least Squares Mean
684430|NCT01516879|Secondary|Percent Change From Baseline in Triglycerides at Week 52||Baseline and Week 52|Full Analysis Set||percent change||Standard Error|Least Squares Mean
684431|NCT01516879|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 52||Baseline and Week 52|Full Analysis Set||percent change||Standard Error|Least Squares Mean
684432|NCT01516879|Secondary|Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 52||Baseline and Week 52|Full Analysis Set||percent change||Standard Error|Least Squares Mean
684433|NCT01516879|Secondary|Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 52||Baseline and Week 52|Full Analysis Set||percent change||Standard Error|Least Squares Mean
684434|NCT01516879|Secondary|Percent Change From Baseline in Apolipoprotein B at Week 52||Baseline and Week 52|Full analysis set||percent change||Standard Error|Least Squares Mean
684435|NCT01516879|Secondary|Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at Week 52||Baseline and Week 52|Full Analysis Set||percent change||Standard Error|Least Squares Mean
684436|NCT01516879|Secondary|Percent Change From Baseline in Total Cholesterol at Week 52||Baseline and Week 52|Full Analysis Set||percent change||Standard Error|Least Squares Mean
684437|NCT01516879|Secondary|Percent Change From Baseline in Total Cholesterol at Week 12||Baseline and Week 12|Full Analysis Set||percent change||Standard Error|Least Squares Mean
684444|NCT01516749|Secondary|Change in Quality of Life Assessments|"The Physician Global Assessment: The physician assessed disease activity on the visual analog scale ranging from 0mm (absent) to 100mm (worst imaginable).
The Patient Global Assessment; The patients reported overall (global) disease activity of HS. Patients were asked What is the overall activity (pain, discharge, odor, and presence of new lesions) of hidradenitis at this visit? with a scale of 0=no acitivity to 100=maximal activity."|Baseline, 8 weeks|Patients who completed 8 weeks of therapy||units on a scale||95% Confidence Interval|Mean
684445|NCT01516749|Primary|Change in Modified Sartorius Score|"At each study visit, the same physician (dermatologist) examined patients and recorded the following: (i) anatomical regions involved: axilla, groin, gluteal (left ⁄right) or other region, 3 points per region; (ii) numbers and scores of lesions (nodule 1 point, fistula 6 points) for each region; (iii) longest distance between two relevant lesions (or size of single lesion) in each region: < 5 cm, 1 point; 5–10 cm, 3 points; > 10 cm, 9 points; and (iv) whether all lesions are separated by normal skin: yes, 0; no (= Hurley III), 9 points.
Regional scores were summed to a total score, ranging from 5 to indefinite. Smaller numbers are better scores and indicate less lesion involvement. Decreases (negative changes) from baseline indicate improvement in disease severity."|Baseline, 8 weeks|The 5 patients who completed 8 weeks of therapy||units on a scale||95% Confidence Interval|Mean
684446|NCT01516736|Secondary|Mortality Due to Infection|Number of patients with death due to infections|Study course (19 weeks)|FAS set = full analysis set||Participants|||Count of Participants
684447|NCT01516736|Secondary|Frequency of Infections by Cycle and Across All Cycles|The number of patients with infections was recorded for each cycle and across all cycles. Infections were identified by the AE documentation page selecting all events coded with System Organ Class “Infections and Infestations”.|across all cycles (18 weeks)|Patients with more than 1 event during the study (overall) are counted only once. FAS set = full analysis set||Participants|||Count of Participants
684448|NCT01516736|Secondary|Time to ANC Recovery in Days in Cycle 1|Time to absolute neutrophil count (ANC) recovery was defined as the time in days from ANC nadir until the patient’s ANC had increased to ≥ 2 × 10^9 cells/L after the nadir in Cycle 1.|across Cycle 1 (3 weeks)|FAS set = full analysis set||days||Standard Deviation|Mean
684449|NCT01516736|Secondary|Number of Patients With ANC Nadir Per Day in Cycle 1|Numbers of patients with ANC nadir based per day during Cycle 1 are given.|Cycle 1 (3 weeks)|FAS set = full analysis set||Participants|||Count of Participants
684450|NCT01516736|Secondary|Depth of ANC Nadir in Cycle 1|The depth of ANC nadir was defined as the patient’s lowest ANC (10^9 cells/L) in Cycle 1.|Cycle 1 (3 weeks)|FAS set = full analysis set||10^9 cells/L||Standard Deviation|Mean
684451|NCT01516736|Secondary|Number of Patients With at Least One Episode of Fever by Cycle and Across All Cycles|Fever was defined as an oral body temperature of ≥ 38.3°C. Fever episodes were described by maximum oral temperature and the number of patients who had fever at least once.|across al cycles (18 weeks)|Patients with more than 1 event during the study (overall) are counted only once. FAS set = full analysis set||Participants|||Count of Participants
684452|NCT01516736|Secondary|Incidence of Febrile Neutropenia (FN)|FN was defined as oral temperature ≥ 38.3°C while having an absolute neutrophil count (ANC) < 0.5 × 10^9 cells/L. Serious treatment-emergent adverse events (TEAEs) were reconciled with the fever and ANC results recorded in the patient diary and CRF and therefore only the serious TEAEs of FN (“febrile neutropenia”, “neutropenic sepsis”) were taken into account.|across all cycles (18 weeks)|FAS set = full analysis set||Participants|||Count of Participants
684453|NCT01516736|Primary|Mean Duration of Severe Neutropenia (DSN) During Cycle 1 of Chemotherapy|Mean duration of severe neutropenia, defined as number of consecutive days with ANC <0.5 × 10^9/l (grade 4 neutropenia).|21 days (Cycle 1 of chemotherapy treatment)|Missing patients in FAS set due to blind data review meeting decision (no ANC profiles available). FAS set = full analysis set; PP set = per protocol set||days||Standard Deviation|Mean
684454|NCT01516632|Secondary|Continuous Abstinence at 4-weeks Post-quit|Smoking five or fewer cigarettes since quit day at 4 weeks post-quit as verified by a significant other|4 weeks post-quit|||participants|||Number
684455|NCT01516632|Secondary|Point Prevalence|A cigarette, even just a puff, within the last 7 days (yes/no).|4-weeks post-quit|||participants|||Number
684456|NCT01516632|Primary|Continuous Abstinence at 3-months Assessed in Accordance With the NIH Behavior Change Consortium's Recommendations|"Continuous abstinence is defined as 5 or fewer cigarettes smoked since one's quit date. The question was asked based upon West et al., 2005: Have you smoked at all, even just a puff, since [insert quit date]? If yes, the respondent will be probed for how many cigarettes were smoked. Responses will be categorized into one of three options: A) No, not a puff; B) 1-5 cigarettes; C) More than 5 cigarettes.
Self-reported cessation is confirmed by a significant other."|3-months post-quit|||participants|||Number
684457|NCT01516437|Secondary|Number of Subjects With Positive Oropharyngeal Swab - Culture Testing Results||At Day 0|The analysis was performed on the According-to-Protocol cohort at Day 0, which included all evaluable subjects for whom at least one assay results was available for the blood samples collected at Day 0.||Subjects|||Number
684458|NCT01516437|Secondary|Number of Subjects With Positive Nasopharyngeal Swab - Culture Testing Results||At Day 0|The analysis was performed on the According-to-Protocol cohort at Day 0, which included all evaluable subjects for whom at least one assay results was available for the blood samples collected at Day 0.||Subjects|||Number
684459|NCT01516437|Secondary|Number of Subjects With Positive Sputum - Culture Testing Results||At Day 0|The analysis was performed on the According-to-Protocol cohort at Day 0, which included all evaluable subjects for whom at least one assay results was available for the blood samples collected at Day 0.||Subjects|||Number
684460|NCT01516437|Secondary|Frequency of Specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among CD 40 Ligand (CD40L), Interleukin 2 (IL-2), Tumor Necrosis Factor-α (TNF-α), Interferon-γ (IFN-γ), IL-13 and IL-17 Upon in Vitro Stimulation||At Day 0|The analysis was performed on the According-to-Protocol cohort at Day 0, which included all evaluable subjects for whom at least one assay results was available for the blood samples collected at Day 0.||T cells/million cells||Standard Deviation|Mean
684527|NCT01515345|Secondary|Probable Stent Thrombosis|"Probable stent thrombosis is considered to have occurred in case of
any unexplained death within the first 30 days.
any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause, irrespective of the time after the index procedure"|30days|||participants|||Number
684461|NCT01516437|Secondary|Frequency of Specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among CD 40 Ligand (CD40L), Interleukin 2 (IL-2), Tumor Necrosis Factor-α (TNF-α), Interferon-γ (IFN-γ), IL-13 and IL-17 Upon in Vitro Stimulation||At Day 0|The analysis was performed on the According-to-Protocol cohort at Day 0, which included all evaluable subjects for whom at least one assay results was available for the blood samples collected at Day 0.||T cells/million cells||Standard Deviation|Mean
684462|NCT01516437|Primary|Number of Subjects With PD Enzymatic Inhibition Concentration Greater Than or Equal to (≥) 17.8%|Concentrations were expressed as geometric mean concentrations (GMCs)|At Month 6|The analysis was performed on the According-to-Protocol cohort at Month 6, which included all evaluable subjects for whom at least one assay results was available for the blood samples collected at Month 6.||Subjects|||Number
684463|NCT01516437|Primary|Number of Subjects With PD Enzymatic Inhibition Concentration Greater Than or Equal to (≥) 17.8%|Concentrations were expressed as geometric mean concentrations (GMCs)|At Day 0|The analysis was performed on the According-to-Protocol cohort at Day 0, which included all evaluable subjects for whom at least one assay results was available for the blood samples collected at Day 0.||Subjects|||Number
684464|NCT01516437|Primary|Concentrations for Serum Protein-D Enzymatic Inhibition|Concentrations are presented as geometric mean concentrations (GMCs). The reference seropositivity cut-off value was ≥ 17.8%.|At Month 6|The analysis was performed on the According-to-Protocol cohort at Month 6, which included all evaluable subjects for whom at least one assay results was available for the blood samples collected at Month 6.||EU/mL||95% Confidence Interval|Geometric Mean
684465|NCT01516437|Primary|Concentrations for Serum Protein-D Enzymatic Inhibition|Concentrations are presented as geometric mean concentrations (GMCs). The reference seropositivity cut-off value was ≥ 17.8%.|At Day 0|The analysis was performed on the According-to-Protocol cohort at Day 0, which included all evaluable subjects for whom at least one assay results was available for the blood samples collected at Day 0.||EU/mL||95% Confidence Interval|Geometric Mean
684466|NCT01516437|Primary|Anti-pneumolysin Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EU/mL)|At Month 6|The analysis was performed on the According-to-Protocol cohort at Month 6, which included all evaluable subjects for whom at least one assay results was available for the blood samples collected at Month 6.||EU/mL||95% Confidence Interval|Geometric Mean
684467|NCT01516437|Primary|Anti-pneumolysin Antibody Concentrations|The analysis was performed on the According-to-Protocol cohort at Day 0, which included all evaluable subjects for whom at least one assay results was available for the blood samples collected at Day 0.|At Day 0|The analysis was performed on the According-to-Protocol cohort at Day 0, which included all evaluable subjects for whom at least one assay results was available for the blood samples collected at Day 0.||EU/mL||95% Confidence Interval|Geometric Mean
684468|NCT01516437|Primary|Anti-Pneumococcal Histidine Triad D Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EU/mL)|At Month 6|The analysis was performed on the According-to-Protocol cohort at Month 6, which included all evaluable subjects for whom at least one assay results was available for the blood samples collected at Month 6.||EU/mL||95% Confidence Interval|Geometric Mean
684469|NCT01516437|Primary|Anti-Pneumococcal Histidine Triad D Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EU/mL)|At Day 0|The analysis was performed on the According-to-Protocol cohort at Day 0, which included all evaluable subjects for whom at least one assay results was available for the blood samples collected at Day 0.||EU/mL||95% Confidence Interval|Geometric Mean
684470|NCT01516437|Primary|Anti-protein D Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EU/mL)|At Month 6|The analysis was performed on the According-to-Protocol cohort at Month 6, which included all evaluable subjects for whom at least one assay results was available for the blood samples collected at Month 6.||EU/mL||95% Confidence Interval|Geometric Mean
684471|NCT01516437|Primary|Anti-protein D Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per millilitre (EU/mL)|At Day 0|The analysis was performed on the According-to-Protocol cohort at Day 0, which included all evaluable subjects for whom at least one assay results was available for the blood samples collected at Day 0.||EU/mL||95% Confidence Interval|Geometric Mean
684472|NCT01516268|Primary|Narcotic Dosage|The total dosage of morphin consumed by the patients in sufentanil or control group.|over 24 hours after surgery|||mgm,.||Standard Deviation|Mean
684473|NCT01516268|Secondary|Pain||24h||||||
684474|NCT01516268|Primary|Narcotic Dosage||24 h||||||
684475|NCT01516034|Secondary|Tolerability Score|The tolerability of the procedure will be scored by the subject using a Pain Visual Analog Scale on a 0 to 10 scale where 10 represents the highest degree of pain and 0 represents a complete lack of pain.|0, 2, 4, 6, 8, 10 weeks (after every treatment)||||||
684476|NCT01516034|Primary|Tattoo Removal Efficiency|"Extent of Tattoo removal is quantified in 2 methods based on photographs taken at the baseline visit and at the termination visit:
Scoring by independent dermatologist
Measuring pigment clearance using image analysis"|6 months (termination)|The number of participants that completed follow up.|||||
684477|NCT01516008|Secondary|Patient Global Impression of Change (PGI-C) Score at 72 Hours|The PGI-C is a 7-point scale that requires the patients to assess how much their illness has improved or worsened relative to a baseline state at the beginning of the intervention. The response options are: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; and 7=very much worse. Higher scores indicate worsening.|Baseline (Day 1) and 72 hours|Intent-to-treat (ITT) analysis set, which included all randomized participants with at least 1 dose of study medication.||Percentage of participants|||Number
684528|NCT01515345|Primary|Any Bleeding Event|"Bleeding classified by the TIMI hemorrhage classification scheme:
Minor: any clinically overt sign of hemorrhage (including imaging) that is associated with a hemoglobin drop of 3 to < 5 g/dL
Major: (1) if it is intracranial, or (2) clinically significant overt signs of hemorrhage associated with a drop inhemoglobin of > 5 g/dL"|30days|||participants|||Number
684529|NCT01515345|Primary|Definite Stent Thrombosis|"The angiographic or pathological confirmation of stent thrombosis is called definite stent thrombosis"|30 days|||participants|||Number
684478|NCT01516008|Secondary|Sum of Pain Relief and Pain Intensity Differences (SPRID) Over 12, 24, 48, and 72 Hours|Participants rated pain relief rated on 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Pain Intensity (PI) was assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. PRID is the sum of pain relief and PID at the same assessment time. SPRID was calculated as the time-weighted Sum of PRID scores over 12, 24, 48, and 72 hours. Total score ranges from -120 (worst) to 168 (best) for SPRID12, -240 (worst) to 336 (best) for SPRID24, -480 (worst) to 672 (best) for SPRID48, and -720 (worst) to 1008 (best) for SPRID72. A higher value of SPRID indicates greater pain relief.|12, 24, 48, and 72 hours|Intent-to-treat (ITT) analysis set, which included all randomized participants with at least 1 dose of study medication. Last-observation-carried-forward imputation method used for missing values.||Scores on a scale||Standard Deviation|Mean
684479|NCT01516008|Secondary|Total Pain Relief (TOTPAR) Over 12, 24, 48, and 72 Hours|Participants rated pain relief rated on 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum of pain relief scores up to Hour 12, 24, 48, and 72 hours. Total score ranges from 0 (worst) to 48 (best) for TOTPAR12, 0 (worst) to 96 (best) for TOTPAR24, 0 (worst) to 192 (best) for TOTPAR48, and 0 (worst) to 288 (best) for TOTPAR72. A higher value of TOTPAR indicated greater pain relief.|12, 24, 48, and 72 hours|Intent-to-treat (ITT) analysis set, which included all randomized participants with at least 1 dose of study medication. Last-observation-carried-forward imputation method used for missing values||Scores on a scale||Standard Deviation|Mean
684480|NCT01516008|Secondary|Sum of Pain Intensity Differences (SPID) Over 12, 24, and 72 Hours|Pain Intensity (PI) was assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted Sum of PID scores over 12, 24, and 72 hours. Total score ranges from -120 (worst) to 120 (best) for SPID12, -240 (worst) to 240 (best) for SPID24, -720 (worst) to 720 (best) for SPID72. A higher value of SPID indicates greater pain relief.|12, 24, and 72 hours|Intent-to-treat (ITT) analysis set, which included all randomized participants with at least 1 dose of study medication. Last-observation-carried-forward imputation method used for missing values.||Scores on a scale||Standard Deviation|Mean
684481|NCT01516008|Secondary|Response Rate for 50 Percent or Greater Reduction in Pain Intensity at 12, 24, 48, and 72 Hours|Response rate was defined as the percentage of participants with a 50 percent or greater reduction in pain intensity from baseline to 12, 24, 48, and 72 hours. Pain intensity was assessed on a 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Participants with no assessment at the given time point, who used an analgesic medication prior to the time point, or who had worse pain intensity at the time point compared to baseline were assigned a percent reduction of 0 percent.|12, 24, 48, and 72 hours|Intent-to-treat (ITT) analysis set, which included all randomized participants with at least 1 dose of study medication.||Percentage of participants|||Number
684482|NCT01516008|Secondary|Response Rate for 30 Percent or Greater Reduction in Pain Intensity at 12, 24, 48, and 72 Hours|Response rate was defined as the percentage of participants with a 30 percent or greater reduction in pain intensity from baseline to 12, 24, 48, and 72 hours. Pain intensity was assessed on a 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Participants with no assessment at the given time point, who used an analgesic medication prior to the time point, or who had worse pain intensity at the time point compared to baseline were assigned a percent reduction of 0 percent.|12, 24, 48, and 72 hours|Intent-to-treat (ITT) analysis set, which included all randomized participants with at least 1 dose of study medication.||Percentage of participants|||Number
684483|NCT01516008|Secondary|Percent Reduction in Pain Intensity From Baseline at 12, 24, 48, and 72 Hours|Pain intensity was assessed on a 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Participants with no assessment at the given time point, who used an analgesic medication prior to the time point, or who had worse pain intensity at the time point compared to baseline were assigned a percent reduction of 0 percent.|Baseline (Day 1) and 12, 24, 48, and 72 hours|Intent-to-treat (ITT) analysis set, which included all randomized participants with at least 1 dose of study medication.||Percentage Reduction||Inter-Quartile Range|Median
684484|NCT01516008|Secondary|Time to First Rescue Medication Use|Rescue medication was defined as any analgesic medication used for participants discontinued due to lack of efficacy (including those started at time of discontinuation) or analgesic medication used during the double-blind period for completed participants.|Up to 48 hours|Intent-to-treat (ITT) analysis set, which included all randomized participants with at least 1 dose of study medication.||Hours||Inter-Quartile Range|Median
684485|NCT01516008|Primary|Sum of Pain Intensity Differences (SPID) Over 48 Hours|Pain Intensity (PI) was assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted Sum of PID scores over 48 hours. Total score ranges from -480 (worst) to 480 (best) for SPID48. A higher value of SPID indicates greater pain relief.|48 hours|Intent-to-treat (ITT) analysis set, which included all randomized participants with at least 1 dose of study medication. Last-observation-carried-forward imputation method used for missing values.||Scores on a scale||Standard Deviation|Mean
684486|NCT01515956|Secondary|Change From Baseline in Normalized Growth Rate Z-Scores|Changes in growth over time will be assessed using anthropometric measurements and radiographs of lower extremities. Z-scores are the normalized scores derived from the reference population mean and standard deviation (A positive change from baseline indicates that the population has moved closer to the reference population and represents a positive outcome).|Baseline to Week 52|Efficacy analysis set - All enrolled patients with at least 1 post treatment efficacy measurement will be included in efficacy analyses.||z-score||Standard Deviation|Mean
684487|NCT01515956|Secondary|Percent Change From Baseline to Week 52 in Urinary Keratan Sulfate Measures|Percent Change from Baseline to Week 52 for Urinary Keratan Sulfate measures.|Baseline to Week 52|Efficacy Analysis Set - All enrolled patients with at least 1 post treatment efficacy measurement will be included in efficacy analyses.||percentage change||Standard Deviation|Mean
684488|NCT01515956|Primary|To Evaluate Safety and Tolerability of Infusions of BMN 110 at a Dose of 2.0 mg/kg/Week Over a 52-week Period in MPS IVA Subjects Less Than 5 Years of Age at Time of First Study Drug Infusion|Number of Participants Experiencing Adverse Events|52 weeks|Safety Population||Participants|||Count of Participants
684489|NCT01515943|Secondary|Number of Participants Classified as Having Improved in All 3 Outcomes Measures From Baseline to 6 Weeks by Treatment Group|"Improvement in all 3 outcome measures at 6 weeks will be defined as follows:
Convergency Insufficiency Symptom Survey (CISS): Improvement of 9 or more points since baseline
Near point of convergence (NPC) break: 6-week/baseline mean NPC break <0.763
Positive fusional vergence (PFV) blur: 6-week/baseline mean PFV blur >1.419
(Note: All 3 criteria must be met in order to be classified as an improver at the 6-week visit)."|6 weeks after randomization (baseline)|The analysis was limited to participants who completed the 6-week visit within the pre-specified analysis window (4 to <10 weeks). Descriptive statistics were performed to compute the number and proportion of participants by treatment group.||participants|||Number
684490|NCT01515943|Secondary|Number of Participants Classified as Having Met Success Criteria for Both Clinical Measures at 6 Weeks by Treatment Group|"The number of subjects classified as a success based on clinical measures of CI (mean NPC break & mean PFV blur) at the 6-week visit. Clinical success is defined according to whether both criteria (below) are met as follows:
Near point of convergence (NPC) break: 6-week/baseline mean NPC break <0.763 and a 6-week mean NPC break <6 cm
Positive fusional vergence (PFV) blur: 6-week/baseline mean PFV blur >1.419 and a 6-week mean PFV blur >15 pd"|6-weeks after randomization (baseline)|The analysis was limited to participants who completed the 6-week visit within the pre-specified analysis window (4 to <10 weeks). Descriptive statistics were performed to compute the number and proportion of participants by treatment group.||participants|||Number
684491|NCT01515943|Secondary|Number of Participants Classified as Having Met Success Criteria Based on the Mean PFV Blur at 6 Weeks by Treatment Group|The number of subjects who are classified as a success based on the mean PFV blur at the 6-week visit. Success is based on the mean PFV (positive fusional vergence) blur, defined as having a mean PFV blur of >15 pd at 6 weeks and a 6-week to baseline ratio of >1.419 for mean PFV blur.|6 weeks after randomization (baseline)|The analysis was limited to participants who completed the 6-week visit within the pre-specified analysis window (4 to <10 weeks). Descriptive statistics were performed to compute the number and proportion of participants by treatment group.||participants|||Number
684492|NCT01515943|Secondary|Number of Participants Classified as Having Met Success Criteria Based on the Mean NPC Break at 6 Weeks by Treatment Group|The number of subjects who are classified as a success based on the mean NPC break at the 6-week visit. Success is based on the mean NPC (near point of convergence) break is defined as having a mean NPC break of <6 cm at 6 weeks and a 6-week to baseline ratio of <0.763 for mean NPC break.|6 weeks after randomization (baseline)|The analysis was limited to participants who completed the 6-week visit within the pre-specified analysis window (4 to <10 weeks). Descriptive statistics were performed to compute the number and proportion of participants by treatment group.||participants|||Number
684493|NCT01515943|Secondary|Number of Participants Classified as Having Met Success Criteria Based on CI Signs/Symptoms at 6 Weeks by Treatment Group|The number of subjects classified as a success based on signs/symptoms at the 6-week visit. Success is based on the Convergency Insufficiency Symptom Survey (CISS) defined as improvement of 9 or more points from baseline and a 6-week score of <16 points.|6 weeks after randomization (baseline)|The analysis was limited to participants who completed the 6-week visit within the pre-specified analysis window (4 to <10 weeks). Descriptive statistics were performed to compute the number and proportion of participants by treatment group.||participants|||Number
684494|NCT01515943|Secondary|Number of Participants Classified as an Overall Success Based on the 3 Outcomes Measures From Baseline to 6 Weeks by Treatment Group|"To be considered an overall success, each of the following criteria must be met for the 3 outcome measures at 6 weeks:
Convergence Insufficiency Symptom Survey (CISS): 6-week score <16 points and at least 9-point improvement from baseline at 6 weeks
Near point of convergence (NPC) break: 6-week/baseline mean NPC break <0.763 and a mean 6-week NPC break <6 cm
Positive fusional vergence (PFV) blur: 6-week/baseline mean PFV blur >1.419 and a mean 6-week PFV break >15 pd
(Note: All 3 criteria must be met in order to be classified as an overall success at the 6-week visit)."|6 weeks after randomization (baseline)|The analysis was limited to participants who completed the 6-week visit within the pre-specified analysis window (4 to <10 weeks). Descriptive statistics were performed to compute the number and proportion of participants by treatment group.||participants|||Number
684495|NCT01515943|Post-Hoc|Number of Participants Classified as an Overall Success at 12 Weeks in the HB-C Group According to Whether or Not the Computer-based Therapy Program Was Completed at 12 Weeks|"This outcome was limited to participants randomly assigned to the HB-C group.
Completion of the home-based computer therapy program was defined as achieving at least 15 stars on the jump vergence therapy).
Overall success was defined as meeting the following criteria for all 3 outcome measures at 12 weeks:
Convergence Insufficiency Symptom Survey (CISS): 12-week score of <16 points and at least a 9-point improvement from baseline at 12 weeks
Near point of convergence (NPC) break: 12-week/baseline mean NPC break <0.763 and a 12-week mean NPC break <6 cm
Positive fusional vergence (PFV) blur: 12-week/ baseline mean PFV blur > 1.419 and a 12-week mean PFV blur >15 pd"|12 weeks after randomization (baseline)|The analysis was limited to participants who were randomly assigned to the HB-C group who completed the 12-week visit within the pre-specified analysis window (10 to 18 weeks, inclusive).||participants|||Number
684496|NCT01515943|Secondary|Number of Participants Classified as Having Improved in All 3 Outcomes Measures From Baseline to 12 Weeks by Treatment Group|"Improvement in all 3 outcome measures at 12 weeks will be defined as follows:
Convergency Insufficiency Symptom Survey (CISS): Improvement of 9 or more points since baseline
Near point of convergence (NPC) break: 12-week/baseline mean NPC break <0.763
Positive fusional vergence (PFV) blur: 12-week/ baseline mean PFV blur >1.419
(Note: All 3 criteria must be met in order to be classified as an improver at the 12-week primary outcome visit)."|12 weeks after randomization (baseline)|The analysis was limited to participants who completed the 12-week visit within the pre-specified analysis window (10 to 18 weeks, inclusive). Descriptive statistics were performed to compute the number and proportion of participants by treatment group.||participants|||Number
684530|NCT01515306|Secondary|Part B: Immunogenicity of Ramucirumab as Monotherapy - Incidence of Anti-Ramucirumab Antibodies||0 hour on Day 1 of Cycle 1, and 30 days after last dose of study drug||06/2017||||
684531|NCT01515306|Secondary|Part A: Immunogenicity of Ramucirumab in Combination With Paclitaxel - Incidence of Anti-Ramucirumab Antibodies||-1 hour on Day 1 of Cycle 2, and 30 days after last dose of study drug||06/2017||||
684497|NCT01515943|Secondary|Number of Participants Classified as Having Met Success Criteria for Both Clinical Measures at 12 Weeks by Treatment Group|"The number of subjects classified as a success based on clinical measures of CI (mean NPC break & mean PFV blur) at the 12-week visit. Clinical success is defined according to whether both criteria (below) are met as follows:
Near point of convergence (NPC) break: 12-week/baseline mean NPC break <0.763 and a 12-week mean NPC break <6 cm
Positive fusional vergence (PFV) blur: 12-week/baseline mean PFV blur >1.419 and a 12-week mean PFV blur >15 pd"|12-weeks after randomization (baseline)|The analysis was limited to participants who completed the 12-week visit within the pre-specified analysis window (10 to 18 weeks, inclusive). Descriptive statistics were performed to compute the number and proportion of participants by treatment group.||participants|||Number
684498|NCT01515943|Secondary|Number of Participants Classified as Having Met Success Criteria Based on the Mean PFV Blur at 12 Weeks by Treatment Group|The number of subjects who are classified as a success based on the mean PFV blur at the 12-week visit. Success is based on the mean PFV (positive fusional vergence) blur, defined as having a mean PFV blur of >15 pd at 12 weeks and a 12-week to baseline ratio of >1.419 for mean PFV blur.|12 weeks after randomization (baseline)|The analysis was limited to participants who completed the 12-week visit within the pre-specified analysis window (10 to 18 weeks, inclusive). Descriptive statistics were performed to compute the number and proportion of participants by treatment group.||participants|||Number
684499|NCT01515943|Secondary|Number of Participants Classified as Having Met Success Criteria Based on the Mean NPC Break at 12 Weeks by Treatment Group|The number of subjects who are classified as a success based on the mean NPC break at the 12-week visit. Success is based on the mean NPC (near point of convergence) break is defined as having a mean NPC break of <6 cm at 12 weeks and a 12-week to baseline ratio of <0.763 for mean NPC break.|12 weeks after randomization (baseline)|The analysis was limited to participants who completed the 12-week visit within the pre-specified analysis window (10 to 18 weeks, inclusive). Descriptive statistics were performed to compute the number and proportion of participants by treatment group.||participants|||Number
684500|NCT01515943|Secondary|Number of Participants Classified as Having Met Success Criteria Based on CI Signs/Symptoms at 12 Weeks by Treatment Group|The number of subjects classified as a success based on signs/symptoms at the 12-week visit. Success is based on the Convergency Insufficiency Symptom Survey (CISS) defined as improvement of 9 or more points from baseline and a 12-week score of <16 points.|12 weeks after randomization (baseline)|The analysis was limited to participants who completed the 12-week visit within the pre-specified analysis window (10 to 18 weeks, inclusive). Descriptive statistics were performed to compute the number and proportion of participants by treatment group.||participants|||Number
684501|NCT01515943|Primary|Treatment Group Comparison of the Percentage of Participants Classified as an Overall Success at 12 Weeks - HB-C Versus HB-P|"Pairwise treatment group comparison (HB-C versus Placebo) of the percentages of participants meeting success criteria using binomial regression adjusting for baseline covariates of CISS score (<28 points vs ≥ 28 points), mean NPC break (<10 cm vs ≥ 10 cm), and mean PFV blur (≥ 15 PD vs <15 PD) using linear contrasts with Bonferroni adjustment for multiple comparisons.
Overall success was defined as meeting all of the following criteria at 12 weeks:
Convergence Insufficiency Symptom Survey (CISS): 12-week score <16 points and at least 9-point improvement from baseline at 12 weeks
Near point of convergence (NPC) break: 12-week/baseline mean NPC break <0.763 and a mean 12-week NPC break <6 cm
Positive fusional vergence (PFV) blur: 12-week/baseline mean PFV blur >1.419 and a mean 12-week PFV break >15 pd"|12-weeks after randomization (baseline)|The analysis was limited to participants who completed the 12-week visit within the pre-specified analysis window (10 to 18 weeks, inclusive).||Participants|||Count of Participants
684502|NCT01515943|Primary|Treatment Group Comparison of the Percentage of Participants Classified as an Overall Success at 12 Weeks - HB-C Versus HB-PU|"Pairwise treatment group comparison (HB-C versus HB-PU) of the percentages of participants meeting success criteria using binomial regression adjusting for baseline covariates of CISS score (<28 points vs ≥ 28 points), mean NPC break (<10 cm vs ≥ 10 cm), and mean PFV blur (≥ 15 PD vs <15 PD) using linear contrasts with Bonferroni adjustment for multiple comparisons (Type I error rate = 2.5%).
Overall success was defined as meeting all of the following criteria at 12 weeks:
Convergence Insufficiency Symptom Survey (CISS): 12-week score <16 points and at least 9-point improvement from baseline at 12 weeks
Near point of convergence (NPC) break: 12-week/baseline mean NPC break <0.763 and a mean 12-week NPC break <6 cm
Positive fusional vergence (PFV) blur: 12-week/baseline mean PFV blur >1.419 and a mean 12-week PFV break >15 pd"|12 weeks after randomization (baseline)|The analysis was limited to participants who completed the 12-week visit within the pre-specified analysis window (10 to 18 weeks, inclusive).||Participants|||Count of Participants
684503|NCT01515891|Secondary|Area Under the Plasma-concentration Time Curve With Extrapolation to Infinity (AUC0-∞)|Whole blood samples for total radioactivity analysis, plasma samples for total radioactivity analysis, and plasma samples for analysis of BIA 9-1067 and its metabolites|24 hours at the following times: pre-dose and 1, 1.75, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, and 264 hours post-dose|||h⋅ng-eq/mL||Standard Deviation|Mean
684504|NCT01515891|Secondary|Area Under the Plasma-concentration Time Curve Until the Last Quantifiable Sampling Point (AUC0-t)|Whole blood samples for total radioactivity analysis, plasma samples for total radioactivity analysis, and plasma samples for analysis of BIA 9-1067 and its metabolites|24 hours at the following times: pre-dose and 1, 1.75, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, and 264 hours post-dose|||h⋅ng-eq/mL||Standard Deviation|Mean
684505|NCT01515891|Secondary|Time to Reach Maximum Plasma Concentration (Tmax)|Whole blood samples for total radioactivity analysis, plasma samples for total radioactivity analysis, and plasma samples for analysis of BIA 9-1067 and its metabolites|24 hours at the following times: pre-dose and 1, 1.75, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, and 264 hours post-dose|||hours||Standard Deviation|Mean
684506|NCT01515891|Primary|Maximum Plasma Concentration (Cmax)|Whole blood samples for total radioactivity analysis, plasma samples for total radioactivity analysis, and plasma samples for analysis of BIA 9-1067 and its metabolites|24 hours:pre-dose and 1, 1.75, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, and 264 hours post-dose|||ng-eq/mL||Standard Deviation|Mean
684555|NCT01515072|Secondary|Change in Troponins|Change in serum troponin I (ng/mL) from before intervention to terminal value|Subjects will be followed from admission to explantation, an average of 4.5 days|Only donors in whom two troponin I values (one before intervention and another after the initial intervention) were available were included in this analysis||ng/mL||Inter-Quartile Range|Median
684507|NCT01515865|Primary|Percent of Subjects Who Failed to Maintain a Response|"Failure to maintain a response was defined as any randomized subject that met both criterion 1 and criterion 2 below on Day 16:
The Orthostatic Hypotension Symptom Assessment (OHSA) Item 1 score increased by >=4 points compared to baseline. OHSA Item 1 is a dizziness scale that is scored on a range from 0 (no dizziness) to 10 (severe dizziness). A lower score indicates less severe symptoms.
There was an increase in the number of syncopal/near syncopal events or severity of events within 15 minutes of standing compared to those observed at baseline. Syncope was defined as a loss of consciousness, and near syncope was defined as a feeling (e.g., dizziness, lightheadedness, feeling faint, feeling as though one would black out) that, without intervention, would lead to a loss of consciousness."|30 minutes post-dose on Day 16|The Full Analysis Set was defined as all randomized subjects who received at least 1 dose of double-blind investigational product.||percentage of participants|||Number
684508|NCT01515696|Post-Hoc|Necrotizing Enterocolitis|necrotizing enterocolitis stage 2a after Bell|End of study|||participants|||Number
684509|NCT01515696|Secondary|Feeding Tolerance- Full Enteral Feedings|full enteral feeding is defined in days of life from birth until an an infant tolerates an enteral feeding volume of 140ml/kg|days of life from birth until an infant tolerates en enteral feeding volume of 140 ml/kg|per protocol||days||Full Range|Median
684510|NCT01515696|Primary|Time to Complete Meconium Evacuation in Days|Time to complete meconium evacuation in days of life until the complete meconium evacuation from birth up to 40 days of life|days of life until until the complete meconium evacuation from birth up to 40 days of life|per protocol||days of life||Full Range|Median
684511|NCT01515657|Primary|Time to 99% Inhibition of Serum Thromboxane (TxB2)|Aspirin's antiplatelet activity is measured by the capacity of platelets to generate serum thromboxane (a surrogate marker for inhibition of COX-1 by aspirin). Inhibition of serum thromboxane is a key marker of antiplatelet efficacy.|4 days|Pharmacodynamic (PD) Evaluable Population for Time to 99% Inhibition||Hours||Standard Deviation|Mean
684512|NCT01515566|Secondary|Effect of Fentanyl on Walk Distance|Ambulatory patients with breakthrough dyspnea performed a baseline 6 minute walk test (6MWT), and then received either subcutaneous fentanyl or placebo 15 minutes before a second 6MWT. The change in walk distance was documented between the first and second 6MWT.|Baseline 6 minute walk test (6MWT) to second 6MWT, up to 100 minutes for study participation.|||feet||Standard Deviation|Mean
684513|NCT01515566|Primary|Retention Rate|Retention rate is defined as the percentage of subjects able to complete the study.|Baseline to study completion, up to 100 minutes.|||percentage of participants|||Number
684514|NCT01515566|Secondary|Effect of Fentanyl Versus Placebo for Exercise-Induced and Breakthrough Dyspnea|Participants receive either Fentanyl subcutaneous (SQ) 15 minutes before walking test, or Placebo (SQ) 15 minutes before walking test. During the study, trained research staff perform study assessments and monitor participant carefully throughout the study period. Six-minute walk tests were carried out following guidelines from the American Thoracic Society. The intensity of dyspnea at 0, 1, 2, 3, 4, 5 and 6 minute of each walk test were assessed using a validated numeric rating scale (NRS) ranging from 0 (“no shortness of breath”) to 10 (“worst possible shortness of breath”) and every 5 minutes during the rest period.|Baseline to 100 minutes for study participation.|||units on a scale||Standard Deviation|Mean
684515|NCT01515540|Primary|"Pain Intensity on a Visual Analog Scale (VAS) The Scale Had Values From 0-100, Where 0 Represents no Pain and 100 Was the Worst Pain Imaginable."|"the primary hypothesis was that the lidoderm 5% patch was expected to decrease pain intensity post treatment greater than placebo patch.
A lower value on the 0-100 scale is considered to represent less pain. Higher values represent more pain. Greater than 20%-30% decrease in pain is considered clinically meaningful."|2 weeks|based on a literature search.||peak pain intensity||Standard Deviation|Mean
684516|NCT01515488|Secondary|Patient Satisfaction|Custom survey with 4 items capturing satisfaction with Understanding, Ease of Answering Questions, Respect for Privacy, and Overall Feelings. For each item, the lowest possible score was 1 and the highest possible score was 6. For Understanding, the lowest actual score was 2 and the highest actual score was 6. For Ease of Answering Questions, the lowest actual score was 2 and the highest actual score was 6. For Respect for Privacy the lowest actual score was 3 and the highest actual score was 6. For Overall Feelings, the lowest actual score was 3 and the highest actual score was 6. For the (unweighted) average of all 4 items, the lowest possible score was 1 and the highest possible score was 6. The lowest actual score was 3.5 and the highest actual score was 6.0.|Upon completion of triage.|||units on a scale||Standard Deviation|Mean
684517|NCT01515488|Secondary|Accuracy of Medical History|To check for accuracy of medical history information, two RAs approached enrolled parents during the course of their ED visit in the individual patient examination rooms. The RAs conducted a brief face-to-face interview with parents and verified information from the nursing triage summary sheet (for non-kiosk users) and the printout of history sheet from the kiosk users, noting any discrepancies on a Discrepancy Rating Scale. All historical discrepancies were categorized into three groups: major discrepancy, minor discrepancy and no discrepancy.|Upon completion of triage.|||Inaccuracies||Standard Deviation|Mean
684518|NCT01515488|Primary|Triage Time|The time it takes for the patient to be triaged, compared across the kiosk and nurse-initiated triage conditions.|From beginning of triage to completion of triage.|||Seconds||Standard Deviation|Mean
684519|NCT01515423|Secondary|Change From Baseline in Marder Factor Subscale Score at Week 48|5 PANSS Marder factor scores (positive symptoms [range:8 to 56], negative symptoms [range: 7 to 49], disorganized thoughts [range: 7 to 49], uncontrolled hostility/excitement [range: 4 to 28], and anxiety/depression [range: 4 to 28]) were examined to gain insight into the symptoms affected by treatment with the study drug. Negative change from baseline in subscales score for positive symptoms, negative symptoms, disorganized thoughts, uncontrolled hostility/excitement, and anxiety/depression indicates improvement in various symptoms of schizophrenia.|DB Baseline (Week 17) and 48 week or DB Endpoint|mITT analysis set included all participants who were randomly assigned to treatment during Double-blind Phase, received at least 1 dose of study drug and did not have any errors in the delivery of active treatment. Here,N=number of participants analysed is the total participants who were evaluable for this outcome measure.||Units on a scale||Standard Deviation|Mean
684556|NCT01515072|Secondary|Change in Dynamic Compliance|"Change in dynamic compliance of the lung from before intervention to terminal value
Cdyn = Dynamic compliance; Vt = tidal volume; PIP = Peak inspiratory pressure (the maximum pressure during inspiration); PEEP = Positive End Expiratory Pressure:
Cdyn= Vt/PIP - PEEP"|Subjects will be followed from admission to explantation, an average of 4.5 days|||L/cm H20||Inter-Quartile Range|Median
684520|NCT01515423|Secondary|Change From Baseline in Positive and Negative Syndrome Subscales Score at Week 48|The neuropsychiatric symptoms of schizophrenia were assessed by means of the 30-item Positive and Negative Syndrome Scale (PANSS). The PANSS provides a total score (sum of the scores of all 30 items) ranging from 30 to 210, higher scores indicate more severe neuropsychiatric symptoms of schizophrenia. Scores for 3 subscales, that is, for positive subscale (sum of the scores of all 7 items) and negative subscale (sum of the scores of all 7 items) ranges from 7 (absent) to 49 (extreme psychopathology), and for the general psychopathology subscale (sum of the scores of all 16 items) score ranges from 16 (absent) to 112 (extreme psychopathology).|DB Baseline (Week 17) and 48 week or DB Endpoint|mITT analysis set included all participants who were randomly assigned to treatment during Double-blind Phase, received at least 1 dose of study drug and did not have any errors in the delivery of active treatment. Here,N=number of participants analysed is the total participants who were evaluable for this outcome measure.||Units on a scale||Standard Deviation|Mean
684521|NCT01515423|Secondary|Percentage of Participants Who Met the Criteria for Symptomatic Remission Based on Andreasen Criteria|Symptomatic remission criterion was defined as having a simultaneous score of mild or less on all selected PANSS items (P1, P2, P3, N1, N4, N6, G5, and G9). Symptomatic remission was defined for the last 6 months of the Double-blind Phase as meeting the remission criterion during the 6 months prior to the End of study visit during the Double-blind Phase, with one excursion allowed.|Weeks 41 to 65|mITT analysis set included all participants who were randomly assigned to treatment during Double-blind Phase, received at least 1 dose of study drug and did not have any errors in the delivery of active treatment. Here,N=number of participants analysed is the total participants who were evaluable for this outcome measure.||Percentage of Participants|||Number
684522|NCT01515423|Secondary|Change From DB Baseline in Personal and Social Performance (PSP) Total Score at Week 48|The Personal and Social Performance (PSP) scale assesses degree of a participant’s dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. Score ranges from 1 to 100. Participants with a score of 71 to 100 have mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision.|DB Baseline (Week 17) and 48 week or DB Endpoint|mITT analysis set included all participants who were randomly assigned to treatment during Double-blind Phase, received at least 1 dose of study drug and did not have any errors in the delivery of active treatment. Here,N=number of participants analysed is the total participants who were evaluable for this outcome measure.||Units on a scale||Standard Deviation|Mean
684523|NCT01515423|Secondary|Change From DB Baseline in Clinical Global Impression Severity (CGI-S) Scale Score at Week 48|"The Clinical Global Impression Severity (CGI-S) rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher scores indicate worsening."|DB Baseline (Week 17) and 48 week or DB Endpoint|mITT analysis set included all participants who were randomly assigned to treatment during Double-blind Phase, received at least 1 dose of study drug and did not have any errors in the delivery of active treatment. Here,N=number of participants analysed is the total participants who were evaluable for this outcome measure.||Units on a scale||Standard Deviation|Mean
684524|NCT01515423|Secondary|Change From Double-Blind (DB) Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 48|The neuropsychiatric symptoms of schizophrenia were assessed by means of the 30-item Positive and Negative Syndrome Scale (PANSS). The PANSS provides a total score (sum of the scores of all 30 items) ranging from 30 to 210, higher scores indicate more severe neuropsychiatric symptoms of schizophrenia. Scores for 3 subscales, that is, for positive subscale (sum of the scores of all 7 items) and negative subscale (sum of the scores of all 7 items) ranges from 7 (absent) to 49 (extreme psychopathology), and for the general psychopathology subscale (sum of the scores of all 16 items) score ranges from 16 (absent) to 112 (extreme psychopathology).|DB Baseline (Week 17) and 48 week or DB Endpoint|mITT analysis set included all participants who were randomly assigned to treatment during Double-blind Phase, received at least 1 dose of study drug and did not have any errors in the delivery of active treatment. Here,N=number of participants analysed is the total participants who were evaluable for this outcome measure.||Units on a scale||Standard Deviation|Mean
684525|NCT01515423|Primary|Percentage of Participants Without Relapse at Week 48 During the Double-Blind Phase|Relapse defined as: Psychiatric hospitalization;participant had an increase of 25 percent in total PANSS score from randomization for 2 consecutive assessments separated by 3-7 days if score at randomization was greater than (>) 40; had a 10 point increase in total PANSS score from randomization for 2 consecutive assessments separated by 3-7 days if score at randomization was less than or equal to (<=) 40; deliberate self-injury or exhibited violent behavior resulting in suicide, clinically significant injury;suicidal or homicidal ideation and aggressive behavior;For PANSS items-had a score of greater than or equal to (>=) 5 after randomization for 2 consecutive assessments separated by 3-7 days on any of above items if maximum score for these above PANSS items was <=3 at randomization; had a score of >=6 after randomization for 2 consecutive assessments separated by 3-7 days on any of above items if maximum score for these above PANSS items was 4 at randomization.|Up to 48 weeks|Modified intent-to-treat (mITT) analysis set included all participants who were randomly assigned to treatment during Double-blind Phase, received at least 1 dose of study drug and did not have any errors in delivery of active treatment. Here,N=number of participants analysed is the total participants who were evaluable for this outcome measure.||Percentage of Participants|||Number
684526|NCT01515410|Primary|"The Primary Objective of This Study is to Explore the Efficacy and Tolerability of DM-1992 Compared to a Standard CD/LD IR Formulation as Measured by Percent OFF Time."|"OFF indicates wearing off motor fluctuations before the next levodopa dose. Percent OFF time is calculated as the total OFF time divided by the total awake time for each day and multiplied by 100.
Patient diary-every 30min while awake for 3days prior to initial Day1 as baseline & during the last 3days before Day10 for both treatments for dyskinesia state.
Baseline is the average of the 3 days recorded in the patient diary prior to Day 1 of Period 1.
End of Period is the average of the 3 days recorded in the patient diary prior to Day 10 in each period.
Clinician-Assess efficacy at pre-dose, every 30min for Day1 and hourly for Day10 for dyskinesia state & motor fluctuations at clinic visits."|Baseline and 10 days for each of the 2 study periods|Modified Intent-to-treat (ITT) Population||percentage of time||95% Confidence Interval|Least Squares Mean
684532|NCT01515306|Secondary|Part A: Pharmacokinetics - Dose-Normalized Maximum Observed Drug Concentration (Cmax) of Ramucirumab in the Presence of Paclitaxel|Dose-normalized Cmax was calculated from Cmax divided by the dose.|Cycle 2: 0, 1, 2, 2.5, 3, 6, 8, 25, 49, 73, 97, 169, 265 and 337 hours post ramucirumab infusion|All participants who received ramucirumab and paclitaxel and had sufficient concentration data to calculate ramucirumab Cmax in Cycle 2 of Part A.||micrograms/milliliter/milligram||Geometric Coefficient of Variation|Geometric Mean
684533|NCT01515306|Secondary|Part A: Pharmacokinetics - Dose-Normalized Area Under the Concentration Versus Time Curve of Ramucirumab From Time Zero to Infinity [AUC(0-∞)] in the Presence of Paclitaxel|Dose-normalized AUC(0-∞) was calculated from AUC(0-∞) divided by the dose.|Cycle 2: 0, 1, 2, 2.5, 3, 6, 8, 25, 49, 73, 97, 169, 265 and 337 hours post ramucirumab infusion|All participants who received ramucirumab and paclitaxel and had sufficient concentration data to calculate ramucirumab AUC(0-∞) in Cycle 2 of Part A.||micrograms*hour/milliliters/milligram||Geometric Coefficient of Variation|Geometric Mean
684534|NCT01515306|Primary|Part B: Pharmacokinetics - Dose-Normalized Area Under the Concentration Versus Time Curve of Ramucirumab From Time Zero to Infinity [AUC(0-∞)] as Monotherapy|Dose-normalized AUC(0-∞) was calculated from AUC(0-∞) divided by the dose.|Cycle 1: 0,1, 1.5, 2, 5, 7, 24, 48, 72,168, 264, 336, 408, and 504 hours post ramucirumab infusion|All participants who received ramucirumab and had sufficient concentration data to calculate ramucirumab AUC(0-∞) in Cycle 1 of Part B.||micrograms*hour/milliliter/milligram||Geometric Coefficient of Variation|Geometric Mean
684535|NCT01515306|Primary|Part A: Pharmacokinetics - Dose-Normalized Maximum Observed Drug Concentration (Cmax) of Paclitaxel in Cycle 2|Dose-normalized Cmax was calculated from Cmax divided by the dose. Data presented are Geometric Least Squares (Geo LS) means. Geo LS means were adjusted for cycle, participant and random error.|Cycle 2: -1, 0, 1, 1.5, 2, 5, 7, 24, 48, 72, 96, 168, 264 and 336 hours post paclitaxel infusion|All participants in drug-drug interaction (DDI) population (who completed Cycle 1 Day 1 and Cycle 2 Day 1 treatment) and had sufficient concentration data to calculate paclitaxel Cmax in Cycle 2.||nanograms/milliliter/milligram||90% Confidence Interval|Least Squares Mean
684536|NCT01515306|Primary|Part A: Pharmacokinetics - Dose-Normalized Maximum Observed Drug Concentration (Cmax) of Paclitaxel in Cycle 1|Dose-normalized Cmax was calculated from Cmax divided by the dose. Data presented are Geometric Least Squares (Geo LS) means. Geo LS means were adjusted for cycle, participant and random error.|Cycle 1: 0,1, 1.5, 2, 5, 7, 24, 48, 72 and 168 hours post paclitaxel infusion|All participants in drug-drug interaction (DDI) population (who completed Cycle 1 Day 1 and Cycle 2 Day 1 treatment) and had sufficient concentration data to calculate paclitaxel Cmax in Cycle 1.||nanograms/milliliter/milligram||90% Confidence Interval|Least Squares Mean
684537|NCT01515306|Primary|Part A: Pharmacokinetics - Dose-Normalized Area Under the Concentration Versus Time Curve of Paclitaxel From Time Zero to Infinity [AUC(0-∞)] in Cycle 2|Dose-normalized AUC(0-∞) was calculated from AUC(0-∞) divided by the dose. Data presented are Geometric Least Squares (Geo LS) means. Geo LS means were adjusted for cycle, participant and random error.|Cycle 2: -1, 0, 1, 1.5, 2, 5, 7, 24, 48, 72, 96, 168, 264 and 336 hours post paclitaxel infusion|All participants in drug-drug interaction (DDI) population (who completed Cycle 1 Day 1 and Cycle 2 Day 1 treatment) and had sufficient concentration data to calculate paclitaxel AUC(0-∞) in Cycle 2.||nanograms*hour/milliliter/milligram||90% Confidence Interval|Least Squares Mean
684538|NCT01515306|Primary|Part A: Pharmacokinetics - Dose-Normalized Area Under the Concentration Versus Time Curve of Paclitaxel From Time Zero to Infinity [AUC(0-∞)] in Cycle 1|Dose-normalized AUC(0-∞) was calculated from AUC(0-∞) divided by the dose. Data presented are Geometric Least Squares (Geo LS) means. Geo LS means were adjusted for cycle, participant and random error.|Cycle 1: 0, 1, 1.5, 2, 5, 7, 24, 48, 72 and 168 hours post paclitaxel infusion|All participants in drug-drug interaction (DDI) population (who completed Cycle 1 Day 1 and Cycle 2 Day 1 treatment) and had sufficient concentration data to calculate paclitaxel AUC(0-∞) in Cycle 1.||nanograms*hour/milliliter/milligram||90% Confidence Interval|Least Squares Mean
684557|NCT01515072|Secondary|Change in P:F Ratio|Change in ratio of arterial oxygen pressure:fraction inspired oxygen ratio from before intervention to terminal value|Subjects will be followed from admission to explantation, an average of 4.5 days|||ratio||Inter-Quartile Range|Median
684558|NCT01515072|Secondary|Change in Creatinine Clearance|Change in creatinine clearance (mL/min by Cockcroft-Gault method) from before intervention to terminal value|Subjects will be followed from admission to explantation, an average of 4.5 days|Donors in whom two serum creatinine values (one before intervention and another after the initial intervention) are available.||mL/min||Inter-Quartile Range|Median
684547|NCT01515072|Post-Hoc|Recipient Survival|Kaplan-Meier estimates of 6, 12 and 24 months survival of all recipients|Recipient survival was monitored from transplant date until death up to 2 years as in SRTR data file October 2015|All recipients of organs from donors in the RIPNOD trial and in whom recipient records are available in SRTR were included in this analysis||percentage of participants|||Number
684548|NCT01515072|Post-Hoc|Death-Censored Kidney Graft Survival at 6, 12 and 24 Months|kidney graft survival censored for death with functioning graft|Kidney graft survival was monitored from transplant date until retransplantation or death up to 2 years as in SRTR data file October 2015|Included were kidneys transplanted alone or with pancreas. All kidney grafts transplanted from donors in the RIPNOD trial and in whom recipient records are available in SRTR were included in this analysis. Kidney graft loss is defined as loss of functioning graft or retransplantation during the 24 months post-transplant.||percentage of participants|||Number
684549|NCT01515072|Post-Hoc|Graft Survival|Kaplan-Meier estimates of 6, 12 and 24 months survival of all grafts|Graft survival was monitored from transplant date until retransplantation or death up to 2 years as in SRTR data file October 2015|All grafts transplanted from donors in the RIPNOD trial and in whom recipient records are available in SRTR were included in this analysis. Graft loss is defined as retransplantation or death during the 24 months post-transplant.||percentage of all grafts|||Number
684550|NCT01515072|Post-Hoc|Acute Kidney Rejection|Diagnosis of rejection as documented in the recipient records in the Scientific Registry of Transplant Recipients (SRTR).|6 months after kidney transplantation|This outcome was examined in recipients of in SRTR that received kidneys from donors in the RIPNOD trial||participants|||Number
684551|NCT01515072|Secondary|Pulsatile Perfusion Parameters|Perfusate resistance (mm Hg/mL/min) in machine perfused kidneys.|Up to 24 hours of machine perfusion|||Resistance, mm Hg/mL/min||Standard Deviation|Mean
684552|NCT01515072|Secondary|Delayed Graft Function (DGF) of Kidney Recipients.|DGF is defined as the need for dialysis within the first week post transplantation.|7 days post-transplant|Kidney recipients of donors in each arm.||participants|Kidney Recipients||Number
684553|NCT01515072|Secondary|Six Month Hospital Free Survival of All Organ Recipients|Six month hospital-free survival was defined as the number of days recipients survived following the initial discharge after the transplant.|6 months post-transplant|Recipients of all organs from donors enrolled in the two arms||days||Inter-Quartile Range|Median
684554|NCT01515072|Secondary|Pulsatile Perfusion Flow|Perfusate flow (mL/min) in machine perfused kidneys.|Up to 24 hours of machine perfusion|||mL/min||Standard Deviation|Mean
684648|NCT01514149|Primary|Glycosylated Hemoglobin Change From Baseline (CFB) to Week 18||CFB to Week 18|Completed Population||Percent (%)||Standard Deviation|Mean
684559|NCT01515072|Secondary|Change in Serum Lactate|Change in serum lactate levels (mg/dL) from before intervention to the final value|Subjects will be followed from admission to explantation, an average of 4.5 days|Donors in whom at least two serum lactate levels (one before and one after the initial intervention) were available||mg/dL||Inter-Quartile Range|Median
684560|NCT01515072|Secondary|Change in Vasopressor Score|"Changes in the following: Vasopressor usage, serum Lactate, Creatinine clearance, arterial oxygen pressure:fraction of inspired oxygen (P:F) ratios, Lung Compliance, Cardiac biomarkers, ejection fraction (EF) from 2-dimensional Echocardiogram.
Here we will present data for the change in vasopressor use evaluated using a vasopressor score.
A numerical score calculated for number and dose of Vasopressors in use. The score is calculated using the following formula (from Zuppa AF et. al.CRIT CARE MED 2004 Vol. 32 p 2318-2322):
Vasopressor Score= (dopamine dose[y=ug/kg/min x 1]) + (dobutamine dose [ug/kg/min] x 1) + (epinephrine dose [ug/kg/min] x100) + (norepinephrine dose [ug/kg/min] x 100) + (phenylephrine dose [ug/kg/min] x 100).
The range for our study was 0-4900 with higher doses indicating higher vasopressor use in the donor."|Vasopressor score was determined before aortic cross clamp minus the value prior to the first intervention, an average of 19 hours|Donors in whom vasopressor agent and dose were described in the OPO records before intervention and prior to aortic cross clamp.||units on a scale||Inter-Quartile Range|Median
684561|NCT01515072|Secondary|Number of Organs Transplanted Per Donor|Number of organs transplanted from each organ donor|Within 24 hours of organ recovery|Subjects were organ donors enrolled in this multicenter study||Organs transplanted from each donor||Standard Deviation|Mean
684562|NCT01515072|Primary|Number of Organs Recovered Per Donor|Number of organs recovered per organ donor|At time of organ recovery, up to 1 day|Subjects were organ donors enrolled in this multicenter study||organs recovered per donor||Standard Deviation|Mean
684563|NCT01515046|Secondary|Ascorbate Levels|Ascorbate levels will be taken at the bottom of each cycle to assess therapeutic dose window.|Once every 28 days up to 5 years||||||
684564|NCT01515046|Secondary|F2-isoprostane Levels|F2-isoprostane is a marker of systemic oxidative stress.|Once every 28 days for up to 5 years|Due to n=1 and study termination, the data were not analyzed.|||||
684565|NCT01515046|Secondary|Number of Drug-related Adverse Events Per Cycle|Adverse events linked to ascorbate will be categorized and quantified using CTCAE v4 at the bottom of each cycle. Incidence and frequency will be compared to scientific literature|every 28 days up to 5 years|Due to n=1 and study termination, the data were not analyzed.|||||
684566|NCT01515046|Secondary|Progression Free Survival|Time-to-event outcome measure (initial disease progression) measured in days from cycle 1 day 1 to day of first progression as defined by RECIST criteria from NCI.|up to 5 years|||days|||Number
684567|NCT01515046|Primary|Overall Survival|Time to event outcome measure (death), measured in days from cycle 1 day 1.|up to 5 years|||days|||Number
684568|NCT01514864|Secondary|Number of Participants With Laboratory Testing Results That Meet the Criteria for Grade 3 or 4 Abnormality|Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to adverse event. Laboratory values graded by Common Terminology Criteria for Adverse Events, volume 3. Hemoglobin, Grade 3: <8.0 – 6.5 g/dL, <4.9-4.0 mmol/L, <80-65 g/L. Alkaline phosphatase, Grade 3: >5.0-20.0*upper limit of normal (ULN). Total bilirubin, Grade 3: >3.0-10.0*ULN. Calcium, low, Grade 3: <7.0-6.0 mg/dL, <1.75-1.5 mmol/L.|From enrollment of last patient to 24 months or until all patients have died, whichever occurs first|All participants who received study drug.||Participants|||Number
684569|NCT01514864|Secondary|Number of Patients With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs) Leading to Discontinuation, and Drug-related AEs Leading to Discontinuation|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=having certain, probable, possible, or unknown relationship to study drug.|From enrollment of last patient to 24 months or until all patients have died, whichever occurs first|All participants who received at least 1 dose of study drug||Participants|||Number
684570|NCT01514864|Secondary|Progression-free Survival (PFS)|PFS is defined as the time from treatment start date to the earliest evidence of disease progression or death. Patients who die or whose disease does not progress will be censored on the date of their last tumor assessment.|From Day 1 of study treatment to Week 12|All participants who received at least 1 dose of study drug||Months||90% Confidence Interval|Median
684571|NCT01514864|Secondary|Progression-free Survival (PFS) Distribution|PFS distribution is defined as the percentage of patients with no documentation of disease progression at a specified time point. Confidence interval computed using the Brookmeyer and Crowley method|From Day 1 of study treatment to Week 12|All participants who received at least 1 dose of study drug||Percentage of participants||90% Confidence Interval|Median
684572|NCT01514864|Secondary|Overall Survival|Overall survival is defined as the time from treatment start date to the date of death. If a patient does not die, survival will be censored on the last date the patient was known to be alive.|From enrollment of last patient to 24 months or until all patients have died, whichever occurs first|All participants who received treatment||Months||90% Confidence Interval|Median
684573|NCT01514864|Secondary|Duration of Response (DOR)|DOR is defined as the time from the first assessment documentation of partial response (PR) or complete response (CR) until the first assessment documentation of disease progression.|From enrollment of last patient to 24 months or until all patients have died, whichever occurs first|All participants who received at least 1 dose of study drug. Because no patients had a response of CR or PR, DOR could not be calculated.|||||
684649|NCT01514136|Primary|Degree of Leakage|"The degree of leakage under the baseplate was measured on a 24-point scale where 0 point was the best possible outcome with no leakage under the baseplate and 24-point was the worst possible outcome with leakage under the whole plate.
The scale was developed by Coloplast A/S"|One week|||units on a scale|Participants|Standard Deviation|Mean
684574|NCT01514864|Primary|Objective Response Rate (ORR)|ORR is defined as the percentage of patients with best tumor response of either Partial Response (a 30% or greater decrease in the sum of the longest diameter [LD] of all lesions in reference to the baseline sum LD) or Complete Response (disappearance of clinical and radiologic evidence of target lesions), according to Response Evaluation Criteria in Solid Tumors.|From enrollment of last patient to 24 months or until all patients have died, whichever occurs first|All participants who received at least 1 dose of study drug. Because no patients had a response of CR or PR, ORR could not be calculated.|||||
684575|NCT01514786|Primary|Number of Participants Reporting Preferred Screening Type as Reported by Chart Audits|Chart audits were conducted 6 months after the participant's study visit to determine if screening had occurred and if the type of screen was the same as the participant's preferred type of screening.|6 months following intervention a chart audit will be conducted to determine if CRCS was completed.|||participants|||Number
684580|NCT01514734|Primary|Change in Intraocular Pressure (IOP) at 8 Weeks From Baseline (Prior Therapy).|Intraocular pressure was measured by Goldmann applanation tonometry. Data for the worse eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).|8 weeks|||millimeters mercury (mmHg)||Standard Deviation|Mean
684581|NCT01514630|Primary|HAMD Rating Scores|"Eight weeks of oral creatine supplementation will result in improvements in Hamilton Depression Rating Scale (HAMD) in female methamphetamine users. HAMD scoring is based on 17 items. Minimum score is 0 and maximum 52. A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate or severe depression.
0-7 = Normal 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severe Depression
≥ 23 = Very Severe Depression"|Over the course of eight weeks. Depression rating scores will be measured weekly for eight weeks for each subject enrolled.|||Units on a scale||Standard Deviation|Mean
684582|NCT01514513|Secondary|Adverse Events|Number of participants with adverse events|15 days|||participants|||Number
684583|NCT01514513|Primary|The Proportion Within Each Treatment Group of Subjects Who Have no Live Lice|No live lice 15 days following initial treatment|15 days|||participants|||Number
684584|NCT01514461|Secondary|Number of Patients Reported With Any Adverse Event, Serious Adverse Event and Death||52 weeks|Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.||Participants|||Number
684585|NCT01514461|Secondary|Pharmacokinetics of LCQ908- Average Observed Blood Concentration (Cavg)|Average observed blood concentration measured by (AUC0-24)/24.|0, 1, 2, 3, 4, 6, and 24 hours at Week 12|Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.||ng/mL||Standard Deviation|Mean
684586|NCT01514461|Secondary|Pharmacokinetics of LCQ908- Time to Reach Maximum Concentration Following Drug Administration Tmax (Hours)||0, 1, 2, 3, 4, 6, and 24 hours at Week 12|Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.||hours||Full Range|Median
684587|NCT01514461|Secondary|Pharmacokinetics of LCQ908- Area Under the Plasma Concentration Time Curve AUC (0-24hour)|The area under the concentration-time curve from time zero to 24 hours after drug administration was calculated by using linear trapezoidal rule.|0, 1, 2, 3, 4, 6, and 24 hours at Week 12|Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment||ng/mL *hr||Standard Deviation|Mean
684588|NCT01514461|Secondary|Pharmacokinetics of LCQ908 - Trough Concentration (Cmin) and Observed Maximum Blood Concentration (Cmax)|Lowest observed blood concentration (Cmin) and observed maximum blood concentration (Cmax) following drug administration derived from non-compartmental analysis using scheduled sampling time for the whole dataset.|0, 1, 2, 3, 4, 6, and 24 hours at Week 12|Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment||ng/mL||Standard Deviation|Mean
684725|NCT01512979|Secondary|Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 24 Weeks of Treatment)|The proportion of patients who achieved HbA1c lowering by at least 0.5% after 24 weeks of treatment.The model includes treatment, and continuous baseline HbA1c.|Baseline and 24 weeks|Patients from PPCC. Non-completers considered as failures.||participants|||Number
684589|NCT01514461|Secondary|Percent Change From Baseline for Postprandial Triglycerides Following the Standardized Meal Tolerance Test at Week 12|Post prandial peak triglycerides – maximum triglyceride value over 0-24 hours Post prandial triglycerides AUC0-24 – area under the time curve for triglycerides over 0-24 Adjusted geometric means are calculated by back-transforming the adjusted means from the model and expressed as a percentage change from baseline. hours|0-24 hours at Baseline, Week 12|Full analysis set (FAS) consisted of all randomized patients, except for those who were mis-randomized. For each category, the number of randomized patients who have non-missing values are included in this analysis.||Percent change||95% Confidence Interval|Geometric Mean
684590|NCT01514461|Secondary|Percent Change From Baseline in Fasting Triglycerides||Baseline, 24 weeks, 52 weeks|Full analysis set (FAS) consisted of all randomized patients, except for those who were mis-randomized.||Percent change||95% Confidence Interval|Geometric Mean
684591|NCT01514461|Secondary|Percentage of Patients Achieving Fasting Triglycerides (TG) Target Thresholds|Percentage of patients reaching target values of <1000 mg/dL or target values of < 2000 mg/dL for fasting triglycerides is reported. Pecentage calculated as (m/n)*100; where 'm' The number of patients who reach target values for fasting triglyceride, 'n' the number of patients with non-missing fasting triglyceride.|12 weeks, 24 weeks, 52 weeks|Full analysis set (FAS) consisted of all randomized patients, except for those who were mis-randomized.||Percentage of patients|||Number
684592|NCT01514461|Secondary|Percentage of Patients Responding to Investigational Treatment by Achieving Fasting Triglycerides (TG) of at Least 40% From Baseline|Percentage calculated as (m/n)*100 where m = number of patients who respond; n = the number of patients with non-missing fasting triglyceride.|Baseline, 12 weeks, 24 weeks, 52 weeks|Full analysis set (FAS) consisted of all randomized patients, except for those who were mis-randomized.||Percentage of participants|||Number
684593|NCT01514461|Secondary|Percentage of Patients Responding to Investigational Treatment by Achieving Final Fasting Triglycerides < 8.4 mmol/L (750 mg/dL)|Percentage calculated as (m/n)*100 where m = number of patients who respond; n = the number of patients with non-missing fasting triglyceride.|12 weeks, 24 weeks, 52 weeks|Full analysis set (FAS) consisted of all randomized patients, except for those who were mis-randomized.||Percentage of participants|||Number
684594|NCT01514461|Secondary|Percentage of Patients Responding to Investigational Treatment by Achieving Fasting Triglycerides (TG) of at Least 40% From Baseline or Final Fasting TG < 8.4 mmol/L (750 mg/dL)|Percentage calculated as (m/n)*100 where m = number of patients who respond; n = the number of patients with non-missing fasting triglyceride.|Baseline, 12 weeks, 24 weeks, 52 weeks|Full analysis set (FAS) consisted of all randomized patients, except for those who were mis-randomized.||Percentage of participants|||Number
684595|NCT01514461|Primary|Percent Change in Fasting Triglycerides From Baseline to 12 Weeks|Blood samples were collected for a fasting lipid panel, including triglycerides. If the 12-week value was missing, the measurement value at 12 weeks or the last available post-baseline measurement value during the double-blind treatment period was analyzed. Baseline is defined as the average of fasting triglyceride values taken at day -3 and day 1. Adjusted geometric means are calculated by back-transforming the adjusted means from the model and expressing as a percentage change from baseline.|Baseline to 12 weeks|Full analysis set (FAS) consisted of all randomized patients, except for those who were mis-randomized. The number of randomized patients with non-missing fasting triglycerides values at baseline and Week 12 are included in this analysis.||percent change||95% Confidence Interval|Geometric Mean
684596|NCT01514448|Secondary|Duration of Response (DOR) in Patients Treated With Everolimus After Failure of First-line Sunitinib or Pazopanib Therapy up to 48 Months|The duration of overall response (DOR) was defined as the time from the first occurrence of a confirmed Complete Response (CR) or Partial Response (PR) (as per investigator assessment according to RECIST 1.1) until the date of the first documented disease progression or death due to underlying cancer. If a patient did not have an event or received any further anticancer therapy, duration of overall response was censored at the date of last adequate tumor assessment. Duration of response was displayed only for patients whose best overall response was CR or PR. As none of the patients showed any response (CR or PR), DOR could not be calculated|48 months|Duration of response was displayed only for patients whose best overall response was CR or PR. As none of the patients showed any response (CR or PR), DOR could not be calculated|||||
684597|NCT01514448|Secondary|Overall Survival (OS) of Patients Treated With Everolimus After Failure of First-line Sunitinib or Pazopanib Therapy up to 48 Months|Overall survival (OS) was defined as the time from date of start of treatment to date of death due to any cause. If a patient was not known to have died, survival will be censored at the date of last contact.|48 months|Full Analysis Set (FAS) consisted of all patients who received at least one dose of everolimus.||months||80% Confidence Interval|Median
684598|NCT01514448|Secondary|Progression-Free Survival (PFS) as the Time Interval Between First Intake of Everolimus and First Documented Disease Progression or Death Due to Any Cause at 24 Months|Progression-free survival (PFS) is the time from date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient did not have an event, progression-free survival was censored at the date of last adequate tumor assessment|24 months|Full Analysis Set (FAS) consisted of all patients who received at least one dose of everolimus.||months||80% Confidence Interval|Median
684599|NCT01514448|Secondary|Percentage of Patients With Overall Response Rate (ORR) Treated With Everolimus After Failure of First-line Sunitinib or Pazopanib Therapy at Month 6|Overall response rate (ORR) is the Percentage of patients with a best overall response of complete response (CR) or partial response (PR) by month 6. ORR was assessed according to RECIST 1.1 criteria. Partial response (PR) required at least a 30% decrease in the sum of the longest diameters of all target lesions, taking as reference the baseline sum of the longest diameters. Complete response (CR) required a disappearance of all target and non-target lesions.|Month 6|Full Analysis Set (FAS) consisted of all patients who received at least one dose of everolimus.||percentage of participants|||Number
684650|NCT01513902|Secondary|Taste Assessment|Participants were evaluated for taste assessment using a 5 categories questionnaire. Participants were asked to answer one of the following to describe the taste of oral solution of tofacitinib: Dislike very much, dislike a little, not sure, like a little, or like very much. The taste assessment was only performed for participants who received the oral solution. Number of participants within each category are reported.|Day 1, Day 5|The analysis population was defined as all participants who had received at least 1 oral solution formulation of tofacitinib.||participants|||Number
684600|NCT01514448|Primary|Percentage of Progression-free Patients by Month 6|Percentage of progression-free patients by month 6 after starting everolimus treatment. For the purpose of the binomial design of the study, a patient being 'progression-free' will be defined as a patient without disease progression by month 6 whereas a subject with progressive disease by month 6 will not be counted as 'progression-free'. The primary variable was derived from radiologic tumor assessments according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1.) Disease progression was either 1) a 20% increase in the sum of the longest diameter of all target lesions, taking as reference the smallest sum of the longest diameters of all target lesions recorded at or after baseline (minimum absolute increase 5 mm in sum) or 2) the appearance of a new lesion or 3) the unequivocal progression of non-target lesions overall.|Month 6|Full Analysis Set (FAS) consisted of all patients who received at least one dose of everolimus.||Percentage of participants|||Number
684601|NCT01514422|Secondary|Changes in Young Mania Rating Scale (YMRS)|Measured at baseline and week 8. The YMRS is an 11-item questionnaire to measure the severity of manic symptoms. 7 items are scored 0-4 and the other 4 items are scored 0-8, with overall score range from 0 (normal) to 60 (severe mania).|baseline and week 8|||units on a scale||Standard Deviation|Mean
684602|NCT01514422|Secondary|Change in N-acetylaspartate (NAA), as Measured by 1H-MRS Scan|Measured at baseline and week 8|baseline and week 8|||mmol/L||Standard Deviation|Mean
684603|NCT01514422|Primary|Change in Scores on the Montgomery-Asberg Depression Rating Scale (MADRS)|Measured at baseline and week 8. The MADRS-S has 10-items which are based on mood symptoms over the past 7 days. Each items is scored 0 (normal) to 6 (severe depression) with overall score ranges from 0 (normal) to 60 (severe depression).|baseline and week 8|||units on a scale||Full Range|Mean
684604|NCT01514318|Secondary|Harris Hip Score|A tool for the evaluation of how a patient is doing after their hip is replaced. Based on a total of 100 points possible, each question is awarded a certain number of points based on how it is answered. Questions are further grouped into four categories. The first category is pain, the second category is function, third is functional activities and finally the physical exam results are tabulated, and based on your range of motion. The score is reported as 90-100 for excellent results, 80-90 being good, 70-79 fair, 60-69 poor, and below 60 a failed result.|10 year|||units on a scale||Standard Deviation|Mean
684605|NCT01514318|Secondary|Western Ontario McMaster Arthritis Index (WOMAC)|Standardized questionnaire used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip. It assesses the pain, joint stiffness, physical, social & emotional function of a person with osteoarthritis in determining the overall level of disability. The WOMAC measures five items for pain (score range 0–20), two for stiffness (score range 0–8), and 17 for functional limitation (score range 0–68). For each item, the possible range of scores is therefore 0-100. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. Physical functioning questions cover everyday activities such as stair use, standing up from a sitting or lying position, standing, bending, walking, getting in and out of a car, shopping, putting on or taking off socks, lying in bed, getting in or out of a bath, sitting, and heavy and light household duties.|10 year|||units on a scale||Standard Deviation|Mean
684606|NCT01514318|Primary|Survivorship of the Device|The subject meets the inclusion/exclusion criteria of the study and received a Revelation Hip Stem prior to 2002 that has survived intact without any type of surgery to revise or remove parts or the whole prosthesis.|10 year|Subjects who signed the consent form and completed the study paperwork.||participants|||Number
684607|NCT01514292|Primary|CGM Relative Differences to Laboratory Reference|The outcome measure is measured as the relative differences (%) of the CGM glucose value in reference to a laboratory reference, yellow spring instrument( YSI) glucose measurements.|7 days|||Percentage of difference||Standard Deviation|Mean
684608|NCT01514240|Secondary|Change in IBDQ Scores From Baseline to Weeks 10 - Social Function|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.|10 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 10 data were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
684609|NCT01514240|Secondary|Change in IBDQ Scores From Baseline to Weeks 8 - Social Function|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.|8 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 8 data were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
684610|NCT01514240|Secondary|Change in IBDQ Scores From Baseline to Weeks 4 - Social Function|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.|4 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 4 data were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
684611|NCT01514240|Secondary|Change in IBDQ Scores From Baseline to Weeks 2 - Social Function|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.|2 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 2 data were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
684612|NCT01514240|Secondary|Change in IBDQ Scores From Baseline to Weeks 10 - Emotional Function|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.|10 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 10 data were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
684613|NCT01514240|Secondary|Change in IBDQ Scores From Baseline to Weeks 8 - Emotional Function|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.|8 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 8 data were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
684614|NCT01514240|Secondary|Change in IBDQ Scores From Baseline to Weeks 4 - Emotional Function|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.|4 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 4 data were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
684615|NCT01514240|Secondary|Change in IBDQ Scores From Baseline to Weeks 2 - Emotional Function|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.|2 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 2 data were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
684616|NCT01514240|Secondary|Change in IBDQ Scores From Baseline to Weeks 10 - Systemic Symptom|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.|10 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 10 data were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
684617|NCT01514240|Secondary|Change in IBDQ Scores From Baseline to Weeks 8 - Systemic Symptom|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.|8 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 8 data were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
684618|NCT01514240|Secondary|Change in IBDQ Scores From Baseline to Weeks 4 - Systemic Symptom|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.|4 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 4 data were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
684619|NCT01514240|Secondary|Change in IBDQ Scores From Baseline to Weeks 2 - Systemic Symptom|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.|2 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 2 data were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
684620|NCT01514240|Secondary|Change in IBDQ Scores From Baseline to Weeks 10 - Bowel Function|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.|10 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 10 data were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
684621|NCT01514240|Secondary|Change in IBDQ Scores From Baseline to Weeks 8 - Bowel Function|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.|8 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 8 data were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
684622|NCT01514240|Secondary|Change in IBDQ Scores From Baseline to Weeks 4 - Bowel Function|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.|4 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 4 data were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
684623|NCT01514240|Secondary|Change in IBDQ Scores From Baseline to Weeks 2 - Bowel Function|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.|2 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 2 data were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
684624|NCT01514240|Secondary|Change in Total IBDQ Scores From Baseline to Weeks 10|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.|10 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 10 data were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
684625|NCT01514240|Secondary|Change in Total IBDQ Scores From Baseline to Weeks 8|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.|8 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 8 data were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
684626|NCT01514240|Secondary|Change in Total IBDQ Scores From Baseline to Weeks 4|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.|4 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 4 data were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
684627|NCT01514240|Secondary|Change in Total IBDQ Scores From Baseline to Weeks 2|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.|2 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 2 data were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
684628|NCT01514240|Secondary|Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 100 Points) at Weeks 8|Clinical improvement is defined as CDAI score of <=150 or a decrease in CDAI score from baseline of at least 100 points.|8 Week|All randomised patients who take the investigational products at least once and have data in the treatment period.||Participants|||Number
684629|NCT01514240|Secondary|Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 100 Points) at Weeks 4|Clinical improvement is defined as CDAI score of <=150 or a decrease in CDAI score from baseline of at least 100 points.|4 Week|All randomised patients who take the investigational products at least once and have data in the treatment period.||Participants|||Number
684630|NCT01514240|Secondary|Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 100 Points) at Weeks 2|Clinical improvement is defined as CDAI score of <=150 or a decrease in CDAI score from baseline of at least 100 points.|2 Week|All randomised patients who take the investigational products at least once and have data in the treatment period.||Participants|||Number
684631|NCT01514240|Secondary|Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 70 Points) at Weeks 8|Clinical improvement is defined as CDAI score of <=150 or a decrease in CDAI score from baseline of at least 70 points.|8 Week|All randomised patients who take the investigational products at least once and have data in the treatment period.||Participants|||Number
684632|NCT01514240|Secondary|Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 70 Points) at Weeks 4|Clinical improvement is defined as CDAI score of <=150 or a decrease in CDAI score from baseline of at least 70 points.|4 Week|All randomised patients who take the investigational products at least once and have data in the treatment period.||Participants|||Number
684633|NCT01514240|Secondary|Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 70 Points) at Weeks 2|Clinical improvement is defined as CDAI score of <=150 or a decrease in CDAI score from baseline of at least 70 points.|2 Week|All randomised patients who take the investigational products at least once and have data in the treatment period.||Participants|||Number
684634|NCT01514240|Secondary|Cumulative Remission Rate at Week 8|Remission rate is defined as CDAI score of less than or equal to 150. Cumulative remission rate at Week 8 is obtained by Kaplan-Meier (KM) estimates.|8 Week|All randomised patients who take the investigational products at least once and have data in the treatment period||Percentage of participants||90% Confidence Interval|Number
684635|NCT01514240|Secondary|Cumulative Remission Rate at Week 4|Remission rate is defined as CDAI score of less than or equal to 150. Cumulative remission rate at Week 4 is obtained by Kaplan-Meier (KM) estimates.|4 Week|All randomised patients who take the investigational products at least once and have data in the treatment period||Percentage of participants||90% Confidence Interval|Number
684636|NCT01514240|Secondary|Cumulative Remission Rate at Week 2|Remission rate is defined as CDAI score of less than or equal to 150. Cumulative remission rate at Week 2 is obtained by Kaplan-Meier (KM) estimates.|2 Week|All randomised patients who take the investigational products at least once and have data in the treatment period||Percentage of participants||90% Confidence Interval|Number
684651|NCT01513902|Secondary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Day 5: Pre-dose, 0.5, 1, 2, 4, 8 hours post dose|The PK analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest. Here 'N' signifies those participants who were analyzed for this outcome measure.||hours||Standard Deviation|Mean
685077|NCT01507831|Secondary|Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|HDL-C ITT population.||percent change||Standard Error|Least Squares Mean
684637|NCT01514240|Secondary|Change in Observed CDAI Scores From Baseline to Weeks 8|"Crohn’s Disease Activity Index (CDAI) score is calculated based on the data collected in the diary card. The total CDAI score ranges from 0 to approximately 600, a higher scores indicating more severe disease. The target population of total CDAI score 180 to 400 is defined mild to modarate active Crohn’s disease. Total CDAI score 150 less or equal is evaluated as a remission.
Patients are asked to fill the following items in the diary card (from the morning in preceding day to the morning in current day). (1) Number of liquid or very soft stools (2) Abdominal pain rating (none, mild, moderate, severe) (3) General well-being (generally well, slightly under par, poor, very poor, terrible) (4) Body temperature (if a patient feels fever) (5) Intake of loperamide or other opiates for diarrhoea. The data for the calculation of CDAI score in diary card is then transcribed by the investigator(s) into the eCRFs at each clinical visit."|8 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 8 data were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
684638|NCT01514240|Secondary|Change in Observed CDAI Scores From Baseline to Weeks 4|"Crohn’s Disease Activity Index (CDAI) score is calculated based on the data collected in the diary card. The total CDAI score ranges from 0 to approximately 600, a higher scores indicating more severe disease. The target population of total CDAI score 180 to 400 is defined mild to modarate active Crohn’s disease. Total CDAI score 150 less or equal is evaluated as a remission.
Patients are asked to fill the following items in the diary card (from the morning in preceding day to the morning in current day). (1) Number of liquid or very soft stools (2) Abdominal pain rating (none, mild, moderate, severe) (3) General well-being (generally well, slightly under par, poor, very poor, terrible) (4) Body temperature (if a patient feels fever) (5) Intake of loperamide or other opiates for diarrhoea. The data for the calculation of CDAI score in diary card is then transcribed by the investigator(s) into the eCRFs at each clinical visit."|4 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 4 data were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
684639|NCT01514240|Secondary|Change in Observed CDAI Scores From Baseline to Weeks 2|"Crohn’s Disease Activity Index (CDAI) score is calculated based on the data collected in the diary card. The total CDAI score ranges from 0 to approximately 600, a higher scores indicating more severe disease. The target population of total CDAI score 180 to 400 is defined mild to modarate active Crohn’s disease. Total CDAI score 150 less or equal is evaluated as a remission.
Patients are asked to fill the following items in the diary card (from the morning in preceding day to the morning in current day). (1) Number of liquid or very soft stools (2) Abdominal pain rating (none, mild, moderate, severe) (3) General well-being (generally well, slightly under par, poor, very poor, terrible) (4) Body temperature (if a patient feels fever) (5) Intake of loperamide or other opiates for diarrhoea. The data for the calculation of CDAI score in diary card is then transcribed by the investigator(s) into the eCRFs at each clinical visit."|2 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 2 data were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
684640|NCT01514240|Secondary|Remission After 4-week of Treatment|For the secondary efficacy variable “Remission after 4 weeks of treatment”, Crohn’s Disease Activity Index CDAI scores was used to determine the patient’s response. Remission for this study is defined as a CDAI score of ≤150.|4 Week|All randomised patients who take the investigational products at least once and have data in the treatment period||Participants|||Number
684641|NCT01514240|Secondary|Remission After 2-week of Treatment|For the secondary efficacy variable “Remission after 2 weeks of treatment”, Crohn’s Disease Activity Index CDAI scores was used to determine the patient’s response. Remission for this study is defined as a CDAI score of ≤150.|2 Week|All randomised patients who take the investigational products at least once and have data in the treatment period||Participants|||Number
684642|NCT01514240|Primary|Remission After 8-week of Treatment|For the primary efficacy variable “Remission after 8 weeks of treatment”, Crohn’s Disease Activity Index CDAI scores was used to determine the patient’s response. Remission for this study is defined as a CDAI score of ≤150. A patient who drops out without any remission before week 8 was considered as a nonresponder (no remission) for this analysis. A patient who drops out before Week 8, but was in remission at the time of dropout, was considered in remission after dropout in this analysis.|8 Week|All randomised patients who take the investigational products at least once and have data in the treatment period||Participants|||Number
684643|NCT01514162|Secondary|Report the Hemodynamic Performance of the Valve|"Gradient is the pressure difference from one side of the valve to the other side of the valve. For this study pressure is measured in mmHg.
Mean gradient for each patient is the average of the pressure differences from one side of the valve to the other side of the valve.
Mean gradient for each valve size (19mm, 21mm, 23mm, 25mm, 27mm, 29mm)is the average of the mean gradient for each patient with that valve size."|5 years|Aortic valve mean gradient at 5 years for participants analyzed with a visit and completed assessment||mmHg||Standard Deviation|Mean
684644|NCT01514162|Secondary|Characterize Patient NYHA Functional Classification Status|"The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life.
Class I. Patients with cardiac disease but without resulting limitation of physical activity.
Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest.
Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest.
Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest.
The Criteria Committee of the New York Heart Association. Nomenclature and Criteria for Diagnosis of Diseases of the Heart and Great Vessels. 9th ed. Boston, Mass: Little, Brown & Co; 1994:253-256."|5 years|Number of participants analyzed is those subjects with a visit and completed assessment||participants|||Number
684645|NCT01514162|Primary|Late Adverse Event Incidence|"Late patient years are calculated from 31 days post-implant to the date of the last follow-up visits (or contact) or adverse events.
Late Patient year calculation:[(Number of late adverse events/sum of late patient years) x 100]"|5 years|||event/100-patient years|||Number
684646|NCT01514149|Secondary|Time to Hyperglycemia Rescue||18 weeks|Completed Population||days||Standard Deviation|Mean
684647|NCT01514149|Secondary|Fasting Body Weight CFB to Week 18||CFB to Week 18|Completed Population||kg||Standard Deviation|Mean
684652|NCT01513902|Secondary|Apparent Volume of Distribution (Vz/F)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|Day 5: Pre-dose, 0.5, 1, 2, 4, 8 hours post dose|The PK analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest. Here 'N' signifies those participants who were analyzed for this outcome measure.||liter||Geometric Coefficient of Variation|Geometric Mean
684653|NCT01513902|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||Day 5: Pre-dose, 0.5, 1, 2, 4, 8 hours post dose|The PK analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest.||hours||Full Range|Median
684654|NCT01513902|Secondary|Maximum Observed Plasma Concentration (Cmax)||Day 5: Pre-dose, 0.5, 1, 2, 4, 8 hours post dose|The PK analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest.||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
684655|NCT01513902|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)||Day 5: Pre-dose, 0.5, 1, 2, 4, 8 hours post dose|The PK analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest. Here 'N' signifies those participants who were analyzed for this outcome measure.||nanogram*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
684656|NCT01513902|Primary|Number of Participants With Clinically Significant Vital Signs Abnormalities|Criteria for vital signs of potentially clinical concern included supine/sitting pulse rate of <40 beats per minute (bpm) or >120 bpm, standing pulse rate of <40 bpm or >140 bpm, systolic blood pressure of >=30 millimeters of mercury (mmHg) change from baseline and systolic blood pressure <90 mmHg, diastolic blood pressure >=20 mmHg change from baseline and diastolic blood pressure <50 mm Hg.|Baseline up to Day 5|The safety analysis population included all participants who received at least 1 dose of study drug.||participants|||Number
684657|NCT01513902|Primary|Number of Participants With Laboratory Test Abnormalities|Participants with laboratory test abnormalities of potential clinical concern without regard to baseline abnormality were reported. Criteria: Hematology(hemoglobin,hematocrit,red blood cell[RBC] count:<0.8*lower limit of normal [LLN], platelets:<0.5*LLN/greater than [>]1.75*upper limit of normal[ULN], white blood cell [WBC] count:<0.6*LLN></0>1.5*ULN, lymphocytes, total neutrophils:<0.8*LLN or >1.2*ULN, basophils, eosinophil, monocytes:>1.2*ULN); Liver Function (total bilirubin: >1.5*ULN, aspartate aminotransferase,alanine aminotransferase, alkaline phosphatase:>3.0*ULN, total protein, albumin:<0.8*LLN or >1.2*ULN);Renal Function (blood urea nitrogen, creatinine:>1.3*ULN, uric acid:>1.2*ULN); Electrolytes (sodium:<0.95*LLN or >1.05*ULN,potassium,chloride,calcium,bicarbonate:<0.9*LLN or >1.1*ULN);Clinical chemistry (glucose <0.6*LLN or >1.5*ULN, creatine kinase:>3.0*ULN); Urinalysis (Urine WBC and RBC: greater than or equal to [>=] 6/High Power Field [HPF]).|Baseline up to Day 5|The safety analysis population included all participants who received at least 1 dose of study drug.||participants|||Number
684658|NCT01513902|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) All Causalities|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment emergent AEs included both serious and non-serious AEs.|Baseline up to 28 days after the last dose of study drug (Day 5)|The safety analysis population included all participants who received at least 1 dose of study drug.||participants|||Number
684659|NCT01513902|Primary|Apparent Oral Clearance (CL/F)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is also influenced by the fraction of the dose absorbed. Clearance was estimated by non compartmental analysis (NCA) of PK data. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. It was calculated by dividing the given oral dose by AUCtau. AUCtau is the area under the plasma concentration time-curve from time zero to end of dosing interval.|Day 5: Pre-dose, 0.5, 1, 2, 4, 8 hours post dose|The PK analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest. Here 'number of participants analyzed (N)' signifies those participants who were evaluable for this outcome measure.||liter per hour||Geometric Coefficient of Variation|Geometric Mean
684660|NCT01513590|Secondary|Number of Treatment Emergent AEs (Adverse Events)|A Treatment Emergent Adverse Event (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. Severity was assessed by investigator.|Onset on or after the first day of exposure to investigational product and no later than 7 days after exposure to investigational product|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||events|||Number
684661|NCT01513590|Secondary|Responder for HbA1c (Below 7.0%) Without Severe and Minor Treatment Emergent Hypoglycaemic Episodes During the Last 12 Weeks of Treatment Including Only Subjects Exposed for at Least 12 Weeks|Responder for HbA1c (<7.0%) without severe and minor treatment emergent hypoglycaemic episodes during the last 12 weeks of treatment. Severe + minor hypoglycaemic episodes = confirmed hypoglycaemic episodes. Severe hypoglycaemic episodes: requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes: able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 26|The full analysis set (FAS) included all randomised subjects. Missing data were imputed using LOCF. Data for 15 subjects were excluded, as only subjects exposed for at least 12 weeks were included in this measurement.||participants|||Number
684662|NCT01513590|Secondary|Change From Baseline in Body Weight|Change from baseline in body weight after 26 weeks of treatment.|Week 0, week 26|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. Missing data were imputed using last observation carried forward (LOCF).||kg||Standard Deviation|Mean
684722|NCT01512979|Secondary|Change From Baseline in FPG by Visit Over Time|The change from baseline is the FPG over time minus the baseline FPG. Means are adjusted for treatment, continuous baseline HbA1c, continuous baseline FPG in addition to week repeated within patient, week by baseline FPG interaction and week by treatment interaction.|Baseline, 6, 12, 18 and 24 weeks|Patients from PPCC, Observed Cases||mg/dL||Standard Error|Mean
684663|NCT01513590|Secondary|Number of Severe and Minor Treatment Emergent Hypoglycaemic Episodes|The pool of severe and minor hypoglycaemic episodes was referred to as confirmed hypoglycaemic episodes, which is presented here. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Onset on or after the first day of exposure to investigational product and no later than 7 days after last exposure to investigational product|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||episodes|||Number
684664|NCT01513590|Secondary|Number of Treatment Emergent Nocturnal (00:01-05:59 am) Severe or Minor Hypoglycaemic Episodes|The pool of severe and minor hypoglycaemic episodes was referred to as confirmed hypoglycaemic episodes, which is presented here. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 am.|Onset on or after the first day of exposure to investigational product and no later than 7 days after last exposure to investigational product|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||episodes|||Number
684665|NCT01513590|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|Change from baseline in fasting plasma glucose (FPG) after 26 weeks of treatment.|Week 0, week 26|The full analysis set (FAS) included all randomised subjects. Missing data were imputed using LOCF. At baseline 195 subjects each in IDegAsp BID and BIAsp 30 BID treatment group were analysed.||mmol/L||Standard Deviation|Mean
684666|NCT01513590|Primary|Change From Baseline in HbA1c (Glycosylated Haemoglobin)|Change from baseline in HbA1c after 26 weeks of treatment.|Week 0, week 26|The full analysis set (FAS) included all randomised subjects. Missing data were imputed using last observation carried forward (LOCF).||Percent (%) glycosylated haemoglobin||Standard Deviation|Mean
684667|NCT01513473|Secondary|Insulin Antibodies (Insulin Degludec Specific, Insulin Detemir Specific, Insulin Aspart Specific and Antibodies Cross-reacting to Human Insulin)|Antibody measurements : the values presented are week 52 (LOCF). The measurement of insulin antibodies after 26 and 52 weeks of treatment was done to fulfil the requirement of monitoring the long term immunogenicity. The unit of measure is percentage bound/total (%B/T) for these antibodies. The Antibodies cross reacting to Human Insulin is abbreviated as X-reacting AB Hu Insulin below)|After 52 weeks of treatment|Full Analysis Set (FAS) Included all randomised subjects. LOCF values are presented for this endpoint.||%B/T||Standard Deviation|Mean
684668|NCT01513473|Secondary|Steady-state Plasma Concentrations of Insulin Degludec and Insulin Detemir on Three Different Visits (Three Different Weeks) During the First 26 Weeks of Treatment|Steady state plasma concentrations of insulin degludec and insulin detemir on three different visits (three different weeks) during the trial.|Between week 1 and week 26|Full Analysis Set (FAS) Included all randomised subjects. 1 subject was excluded from the analysis in the IDet arm as he was withdrawn before exposure to trial drug.||pmol/L||Standard Deviation|Mean
684669|NCT01513473|Secondary|Number of Episodes With Self Monitored Blood Ketones Above 1.5 mmol (Capillary Blood Ketone Measurement to be Performed if Self-measured Plasma Glucose (SMPG) Exceeds 14.0 mmol/l (250 mg/dL))|Blood ketones > 1.5mmol/L (Capillary blood ketone measurement to be performed if SMPG exceeds 14.0mmol/L (250mg/dL) )after 26 and 52 weeks of treatment|After 26 weeks and 52 weeks of treatment|Full Analysis Set (FAS) Included all randomised subjects||episodes|||Number
684670|NCT01513473|Secondary|Number of Self-measured Hyperglycaemia (Episodes of PG Above 11.1 mmol/L (200 mg/dL))|Episodes of PG >11.1mmol/L (200mg/dL)|After 26 weeks and 52 weeks of treatment|Safety analysis set included all subjects receiving at least one dose of investigational product.||episodes|||Number
684671|NCT01513473|Secondary|Number of Hypoglycaemic Episodes|Number of hypoglycaemic episodes (severe episodes or episodes with plasma glucose (PG) below or equal to 3.9 mmol/L (70 mg/dL) with or without symptoms of hypoglycaemia) during the trial; nocturnal [11 p.m. - 7 a.m./23:00 – 07:00] and over the entire day (24 hours)|After 26 weeks and 52 weeks of treatment|Safety analysis set included all subjects receiving at least one dose of investigational product.||episodes|||Number
684672|NCT01513473|Secondary|Number of Treatment Emergent Adverse Events (TEAEs)|TEAE is defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment.|After 26 weeks and 52 weeks of treatment|Safety analysis set included all subjects receiving at least one dose of investigational product.||events|||Number
684673|NCT01513473|Secondary|Change From Baseline in Fasting Blood Glucose (FPG) at 52 Weeks (Analysed by Central Laboratory)|Change from baseline in FPG after 52 weeks of treatment.|Week 0, week 52|Full Analysis Set (FAS) Included all randomised subjects. LOCF values are presented for this endpoint. 338 subjects were considered, as 12 excluded from PP analysis set, 1 withdrawn, 11 subjects did not have a valid HbA1c measurements after 12 weeks.||mmol/L||Standard Deviation|Mean
684674|NCT01513473|Secondary|Change From Baseline in Fasting Blood Glucose (FPG) at 26 Weeks (Analysed by Central Laboratory)|Change from baseline in FPG after 26 weeks of treatment.|Week 0, week 26|Full Analysis Set (FAS) Included all randomised subjects. LOCF values are presented for this endpoint. 338 subjects were considered, as 12 excluded from PP analysis set, 1 withdrawn, 11 subjects did not have a valid HbA1c measurements after 12 weeks. FPG samples were missing for 9 subjects.||mmol/L||Standard Deviation|Mean
684675|NCT01513473|Secondary|Change From Baseline in HbA1c (%) at 52 Weeks (Analysed by Central Laboratory)|Change from baseline in HbA1c (%) after 52 weeks of treatments.|Week 0, week 52|Full Analysis Set (FAS) Included all randomised subjects. LOCF values are presented for this endpoint.||percentage of glycosylated haemoglobin||Standard Deviation|Mean
684676|NCT01513473|Primary|Change From Baseline in HbA1c (Glycosylated Haemoglobin) (%) at 26 Weeks (Analysed by Central Laboratory)|Change from baseline in HbA1c (%) after 26 weeks of treatment.|Week 0, week 26|Full Analysis Set (FAS) Included all randomised subjects. LOCF values are presented for this endpoint.||percentage of glycosylated haemoglobin||Standard Deviation|Mean
684723|NCT01512979|Secondary|Occurrence of Treat to Target Efficacy Response (HbA1c <7.0%) After 24 Weeks of Treatment|The proportion of patients who achieved HbA1c below 7.0% after 24 weeks of treatment. The model includes treatment, and continuous baseline HbA1c.|Baseline and 24 weeks|Patients from PPCC. Non-completers considered as failures.||participants|||Number
684677|NCT01513460|Secondary|Mean Percentage of Days With Performance of Usual Activities|A ‘day able to perform usual daily activities’ was defined from diary data as any day where the patient was not prevented from performing their usual daily activities due to respiratory symptoms. The percentage of ‘days able to perform usual daily activities’ was derived and analyzed using a similar mixed model as specified for primary analysis as for the percentage of nights with ‘no nighttime awakenings’.|12 weeks|Participants from the full analysis set (FAS), who had outcome measure data with applicable fixed effects/covariates according to the analysis model, were analyzed only. The full analysis set included all randomized participants who received at least one dose of study drug.||Percentage of days||Standard Error|Mean
684678|NCT01513460|Secondary|Mean Percentage of Nights With 'no Nighttime Awakenings'|A night with 'no nighttime awakenings' is defined from diary data as any night where patient did not wake up due to symptoms. Total number of nights with 'no nighttime awakenings' over treatment period was divided by total number of nights where diary recordings have been made in order to derive percentage of 'no nighttime awakenings' which will be summarized by treatment and analyzed using a similar mixed model as specified for primary analysis. Diary data recorded during the 7 day run-in period was used to calculate baseline percentage of nights 'no nighttime awakenings'.|12 weeks|Participants from the full analysis set (FAS), who had outcome measure data with applicable fixed effects/covariates according to the analysis model, were analyzed only. The full analysis set included all randomized participants who received at least one dose of study drug.||Percentage of nights||Standard Error|Mean
684679|NCT01513460|Secondary|Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication Use|The total number of puffs of rescue medication used over the last 12 h recorded in the morning (nighttime use) and in the evening (daytime use) over the full 12 weeks was divided by the total number of days with non-missing rescue data to derive the mean daytime and nighttime number of puffs of rescue medication. Change from baseline in the mean daytime and nighttime number of puffs of rescue medication was analyzed as for the change from baseline in the mean daily number of puffs of rescue medication.|baseline, 12 weeks|Participants from the full analysis set (FAS), who had outcome measure data with applicable fixed effects/covariates according to the analysis model, were analyzed only. The full analysis set included all randomized participants who received at least one dose of study drug.||puffs of rescue medication||Standard Error|Mean
684680|NCT01513460|Secondary|Change From Baseline in Total Score of the St George’s Respiratory Questionnaire for COPD Patients (SGRQ-C) After 12 Weeks of Treatment|SGRQ-C is a health related quality of life questionnaire consisting of 40 items divided into two components: 1) symptoms, 2) activity& impacts. The lowest possible value is zero and the highest is 100. Higher values corresponded to greater impairment in quality of life. An analysis model included terms for treatment, baseline total SGRQ score, FEV1 and baseline smoking status. The model also contained as fixed effects the baseline total SGRQ score, FEV1 prior to inhalation of short acting bronchodilator, FEV1 post inhalation of short acting bronchodilator and stratification factors as covariates. A negative change from baseline indicates improvement.|12 weeks|Full Analysis Set: The full analysis set included all randomized participants who received at least one dose of study drug.||units on a scale||Standard Error|Mean
684681|NCT01513460|Secondary|Change From Baseline in Mean Trough FEV1|Spirometry was conducted according to internationally accepted standards. Trough FEV1 referred to the mean of FEV1 at 23:15h and 23:45h after the morning dose of study drug. The baseline was defined as the average of FEV1 values taken in the clinic 45min and 15min prior to the first dose of randomized treatment at Visit 3. A mixed model was used and contained treatment as a fixed effect with the baseline measurement of trough FEV1, FEV1 prior to inhalation of short acting bronchodilators, and FEV1 post-inhalation of bronchodilators and stratification factors as covariates. A positive change from baseline indicates improvement.|baseline, 4 weeks, 8 weeks, 12 weeks|Full Analysis Set: The full analysis set included all randomized participants who received at least one dose of study drug.||Liters||Standard Error|Mean
684682|NCT01513460|Secondary|Change From Baseline in Mean Trough FEV1 (Flu/Sal Versus NVA237/Tiotropium+Flu/Sal)|Spirometry was conducted according to internationally accepted standards. Trough FEV1 referred to the mean of FEV1 at 23:15h and 23:45h after the morning dose of study drug. The baseline was defined as the average of FEV1 values taken in the clinic 45min and 15min prior to the first dose of randomized treatment at Visit 3. A mixed model was used and contained treatment as a fixed effect with the baseline measurement of trough FEV1, FEV1 prior to inhalation of short acting bronchodilators, and FEV1 post-inhalation of bronchodilators and stratification factors as covariates. A positive change from baseline indicates improvement.|baseline, 4 weeks, 8 weeks, 12 weeks|Full Analysis Set: The full analysis set included all randomized participants who received at least one dose of study drug.||Liters||Standard Error|Mean
684683|NCT01513460|Primary|Change From Baseline in Mean Trough Forced Expiratory Volume in 1 Second (FEV1) (NVA237 Versus Tiotropium)|Spirometry was conducted according to internationally accepted standards. Trough FEV1 referred to the mean of FEV1 at 23:15 hours and 23:45 hours after the morning dose of study drug. The baseline was defined as the average of FEV1 values taken in the clinic 45 min and 15 min prior to the first dose of randomized treatment at Visit 3. A mixed model was used and contained treatment as a fixed effect with the baseline measurement of trough FEV1, FEV1 prior to inhalation of short acting bronchodilators, and FEV1 post-inhalation of bronchodilators and stratification factors as covariates. A positive change from baseline indicates improvement.|baseline, 12 weeks|Participants from the per-protocol set (PPS), who had values at both baseline and week 12, were included in the analysis. The PPS included all randomized participants who had at least one dose of study drug and who were without any major protocol or non-protocol deviations.||liters||Standard Error|Mean
684684|NCT01513447|Secondary|Total Local Anesthetic Consumption|It is anticipated that intracutaneous sterile water injections will decrease the amount of local anesthetic consumption.|24 hours|||milliliters||Standard Deviation|Mean
684685|NCT01513447|Primary|Number of Participants With Breakthrough Back Labor Pain|It is anticipated that intracutaneous sterile water injections will provide additional pain relief as part of a multimodal analgesic regimen in women, especially in women with back labor.|within 24 hours|||participants|||Number
684724|NCT01512979|Secondary|Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 1.0% After 24 Weeks of Treatment)|The proportion of patients who achieved HbA1c lowering by at least 1.0% after 24 weeks of treatment. The model includes treatment, and continuous baseline HbA1c.|Baseline and 24 weeks|Patients from PPCC. Non-completers considered as failures.||participants|||Number
684686|NCT01513330|Primary|Degree of Leakage. Each Baseplate Can Have a Score From 0-24 Points Were 0 is the Best Possible Outcome (No Leakage) and 24 Points is the Worst Possible Outcome (Full Plate Leakage)|Degree of leakage will be measured by a 25-point leakage scale (no leakage or up till 24 points of leakage), developed by Coloplast A/S. The subjects receive Petri dishes with pre-printed leakage scale on. The subject will place the Petri dish above the used baseplate and indicate where on the baseplate output appears. This is done by ticking of each area on the scale indicating the area of leakage.|14 days|||points on a scale|Participants|Standard Deviation|Mean
684687|NCT01513317|Secondary|Median Number of Red Blood Cell (RBC) Transfusions to Treat Anemia of Myelodysplastic Syndrome (MDS) During the 8 Weeks of Treatment Before Unblinding at Week 13||8 weeks|Intent-to-treat population: Included all randomized participants who completed Week 13 unblinding||RBC Transfusions||Full Range|Median
684688|NCT01513317|Secondary|Mean Changes From Baseline in Percentages of Bone Marrow Blast Cells at Week 13||Baseline and Week 13|Intent-to-treat population: Included all randomized participants with evaluable data at Week 13||Percentage of Bone Marrow Blast Cells||Standard Deviation|Mean
684689|NCT01513317|Secondary|Percentage of Participants Who Did Not Require a Red Blood Cell (RBC) Transfusions to Treat Anemia of Myelodysplastic Syndrome (MDS) in the 8 Weeks of Treatment Before Unblinding at Week 13||8 weeks|Intent-to-treat population: Included all randomized participants||Percentage of Participants|||Number
684690|NCT01513317|Secondary|Percentage of Participants Achieving Hemoglobin Improvement (≥1.5 g/dL Increase From Baseline) Unrelated to Red Blood Cell (RBC) Transfusion at Week 13||Week 13|Intent-to-treat population: Included all randomized participants||Percentage of Participants|||Number
684691|NCT01513317|Secondary|Change From Baseline in the Mean Hemoglobin Concentrations at Week 13||Baseline and Week 13|Intent-to-treat population: Included all randomized participants with evaluable data at Week 13||g/dL||Standard Deviation|Mean
684692|NCT01513317|Primary|Percentage of Participants Who Achieved a Reduction in Red Blood Cell (RBC) Transfusions to Treat Anemia of Myelodysplastic Syndrome (MDS)|Reduction in RBC transfusions to treat the anemia of MDS is defined as a ≥50 percentage relative decrease and a ≥2 unit absolute decrease in RBC transfusions in the 8 weeks before the unblinding (scheduled to occur after 12 weeks of treatment) compared with RBC transfusions in the 8 weeks before the date the informed consent form was signed.|Up to Week 13|Intent-to-treat population: Included all randomized participants||Percentage of participants|||Number
684693|NCT01513291|Secondary|Percentage of Participants With at Least a 30% Reduction From Baseline in Monthly Migraine Days|Participants recorded data in the electronic migraine headache diary in the evening approximately one hour before bed and prior to taking study medication during Screening and the Treatment Period. A migraine was defined as a headache with at least one associated symptom of aura, photophobia, phonophobia, nausea, or vomiting. Percentage of participants with at least 30% reduction in the monthly migraine days during Screening (Baseline) versus during the 12-week Treatment Period was analyzed using a generalized linear mixed effects model.|Baseline and average over Treatment Period (Weeks 0-12)|The population analyzed included participants who received at least one dose of double-blind study treatment and had at least one evaluable endpoint measurement, including those with only a baseline measurement. This outcome measure applied only to the Treatment Period and was not analyzed for the Run-out Period.||Percentage of participants||95% Confidence Interval|Number
684694|NCT01513291|Secondary|Percentage of Participants With at Least a 50% Reduction From Baseline in Monthly Migraine Days|Participants recorded data in the electronic migraine headache diary in the evening approximately one hour before bed and prior to taking study medication during Screening and the Treatment Period. A migraine was defined as a headache with at least one associated symptom of aura, photophobia, phonophobia, nausea, or vomiting. Percentage of participants with at least 50% reduction in the monthly migraine days during the 12-week Treatment Period versus during Screening (Baseline) was analyzed using a generalized linear mixed effects model.|Baseline and average over Treatment Period (Weeks 0-12)|The population analyzed included participants who received at least one dose of double-blind study treatment and had at least one evaluable endpoint measurement, including those with only a baseline measurement. This outcome measure applied only to the Treatment Period and was not analyzed for the Run-out Period.||Percentage of participants||95% Confidence Interval|Number
684695|NCT01513291|Secondary|Mean Change From Baseline in Monthly Headache Days|Participants recorded data in the electronic migraine headache diary in the evening approximately one hour before bed and prior to taking study medication during Screening and the Treatment Period. A headache was defined as headache pain of at least 30 minutes duration or for any duration for which headache treatment was administered. Change in the mean monthly headache days during Screening (Baseline) versus during the 12-week Treatment Period was assessed. A negative number indicates a reduction in mean monthly headache days.|Baseline and average over Treatment Period (Weeks 0-12)|The population analyzed included participants who received at least one dose of double-blind study treatment and had at least one evaluable endpoint measurement, including those with only a baseline measurement. This outcome measure applied only to the Treatment Period and was not analyzed for the Run-out Period.||Days/month||Standard Error|Least Squares Mean
684696|NCT01513291|Primary|Percentage of Participants Discontinued From Study Medication Due to an Adverse Event|An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor’s product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor’s product, is also an adverse event. Statistical analysis compared the Treatment Period arms only.|Treatment Period: Weeks 0-12; Run-out Period: Weeks 13-14|The population analyzed included all randomized participants who received at least one dose of double-blind study treatment.||Percentage of participants|||Number
684697|NCT01513291|Primary|Percentage of Participants With One or More Adverse Events|An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor’s product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor’s product, is also an adverse event. Statistical analysis compared the Treatment Period arms only.|Treatment Period: Weeks 0-12; Run-out Period: Weeks 13-14|The population analyzed included all randomized participants who received at least one dose of double-blind study treatment.||Percentage of participants|||Number
684698|NCT01513291|Primary|Mean Change From Baseline in Monthly Migraine Days|Participants recorded data in the electronic migraine headache diary in the evening approximately one hour before bed and prior to taking study medication during Screening and the Treatment Period. A migraine was defined as a headache with at least one associated symptom of aura, photophobia, phonophobia, nausea, or vomiting. Change in the mean monthly migraine days during Screening (Baseline) versus during the 12-week Treatment Period was assessed. A negative number indicates a reduction in mean monthly migraine days.|Baseline and average over Treatment Period (Weeks 0-12)|The population analyzed included participants who received at least one dose of double-blind study treatment and had at least one evaluable endpoint measurement, including those with only a baseline measurement. This outcome measure applied only to the Treatment Period and was not analyzed for the Run-out Period.||Days/month||Standard Error|Least Squares Mean
684699|NCT01513239|Secondary|Percentage of Participants With CDI Recurrence in Those With Compromised Immunity|CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive lab stool test (local or central) for toxigenic C. difficile. Clinical cure is defined as no diarrhea [2 or fewer loose stools per 24 hours] for 2 consecutive days following completion of SOC therapy for the initial CDI episode in participants who received =< 14 day regimen. Compromised immunity is an active hematological malignancy (including leukemia, lymphoma, multiple myeloma), an active malignancy requiring recent cytotoxic chemotherapy, receipt of a prior hematopoietic stem cell transplant, receipt of a prior solid organ transplant, asplenia, or neutropenia/pancytopenia due to other conditions.|12 weeks|Treated participants with compromised immunity||Percentage of participants|||Number
684700|NCT01513239|Secondary|Percentage of Participants With CDI Recurrence in Those 65 Years and Older|CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive lab stool test (local or central) for toxigenic C. difficile. Clinical cure is defined as no diarrhea [2 or fewer loose stools per 24 hours] for 2 consecutive days following completion of SOC therapy for the initial CDI episode in participants who received =< 14 day regimen.|12 weeks|Treated participants 65 years and older.||Percentage of participants|||Number
684701|NCT01513239|Secondary|Percentage of Participants With CDI Recurrence in Those With Clinically Severe CDI|CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive lab stool test (local or central) for toxigenic C. difficile. Clinical cure is defined as no diarrhea [2 or fewer loose stools per 24 hours] for 2 consecutive days following completion of SOC therapy for the initial CDI episode in participants who received =< 14 day regimen. Participants with clinically severe CDI have a Zar Score greater than or equal to 2 points based on the presence of 1 or more of the following: 1) age >60 years old (1 point); 2) body temperature >38.3°C (>100°F) (1 point); 3) albumin level ˂2.5 mg/dl (1 point); 4) peripheral white blood cell count >15,000 cells/mm^3 within 48 hours (1 point); 5) endoscopic evidence of pseudomembranous colitis (2 points); and 6) treatment in Intensive Care Unit (2 points).|12 weeks|Treated participants with clinically severe CDI||Percentage of participants|||Number
684702|NCT01513239|Secondary|Percentage of Participants With CDI Recurrence in Those With an Epidemic Strain|CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive lab stool test (local or central) for toxigenic C. difficile. Clinical cure is defined as no diarrhea [2 or fewer loose stools per 24 hours] for 2 consecutive days following completion of SOC therapy for the initial CDI episode in participants who received =< 14 day regimen. An epidemic strain includes ribotypes 027, 014, 002, 001, 106 or 020.|12 weeks|Treated participants with an epidemic strain||Percentage of participants|||Number
684703|NCT01513239|Secondary|Percentage of Participants With CDI Recurrence in Those With the 027 Ribotype|CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive lab stool test (local or central) for toxigenic C. difficile. Clinical cure is defined as no diarrhea [2 or fewer loose stools per 24 hours] for 2 consecutive days following completion of SOC therapy for the initial CDI episode in participants who received =< 14 day regimen. The 027 ribotype is a more virulent, epidemic strain responsible for several outbreaks of disease associated with an increased risk of severity and mortality.|12 weeks|Treated participants with the 027 ribotype||Percentage of participants|||Number
684704|NCT01513239|Secondary|Percentage of Participants With CDI Recurrence in Those With a History of CDI in the 6 Months Prior to Enrollment|CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive lab stool test (local or central) for toxigenic C. difficile. Clinical cure is defined as no diarrhea [2 or fewer loose stools per 24 hours] for 2 consecutive days following completion of SOC therapy for the initial CDI episode in participants who received =< 14 day regimen.|12 weeks|Treated participants with a history of CDI in the past 6 months.||Percentage of participants|||Number
684705|NCT01513239|Primary|Percentage of Participants With One or More Infusion-specific Adverse Events on the Day of Infusion or the Day After Infusion|An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the medicinal product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the medicinal product, is also an adverse event.|Up to 24 hours|APaT based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm who was treated with MK-3415, but was not treated with MK-6072, was not analyzed.||Percentage of participants|||Number
684706|NCT01513239|Primary|Percentage of Participants Who Discontinued Study Medication Due to an Adverse Event During 4 Weeks Following Infusion Treatment|An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the medicinal product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the medicinal product, is also an adverse event.|Up to 4 weeks|APaT based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm who was treated with MK-3415, but was not treated with MK-6072, was not analyzed.||Percentage of participants|||Number
685309|NCT01505374|Primary|Visual Analogue Scale Pain Score|The primary outcome is the postoperative pain in each leg within the first 24 hours postoperatively. VAS pain scores could range from 0 to 10. Higher values represent a worse outcome.|Up to postoperative day 1|||units on a scale||Standard Deviation|Mean
684707|NCT01513239|Primary|Percentage of Participants With One or More Serious Drug-related Adverse Events During 4 Weeks Following Infusion Treatment|A serious adverse event (SAE) is any AE occurring at any dose or during any use of the medicinal product that results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or other important medical events. A serious drug-related adverse event is determined by the investigator to be related to the drug.|Up to 4 weeks|APaT based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm who was treated with MK-3415, but was not treated with MK-6072, was not analyzed.||Percentage of participants|||Number
684708|NCT01513239|Primary|Percentage of Participants With One or More Drug-related Adverse Events During 4 Weeks Following Infusion Treatment|An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the medicinal product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the medicinal product, is also an adverse event. A drug-related adverse event is determined by the investigator to be related to the drug.|Up to 4 weeks|APaT based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm who was treated with MK-3415, but was not treated with MK-6072, was not analyzed.||Percentage of participants|||Number
684709|NCT01513239|Primary|Percentage of Participants With One or More Adverse Events During 4 Weeks Following Infusion Treatment|An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the medicinal product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the medicinal product, is also an adverse event.|Up to 4 weeks|All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK- 3415A + SOC arm who was treated with MK-3415, but was not treated with MK-6072, was not analyzed.||Percentage of participants|||Number
684710|NCT01513239|Secondary|Percentage of Participants With CDI Recurrence in Those With Clinical Cure of the Initial CDI Episode|CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive lab stool test (local or central) for toxigenic C. difficile. Clinical cure is defined as no diarrhea [2 or fewer loose stools per 24 hours] for 2 consecutive days following completion of SOC therapy for the initial CDI episode in participants who received =< 14 day regimen.|12 weeks|Treated participants who achieved a clinical cure of the initial CDI episode.||Percentage of participants|||Number
684711|NCT01513239|Secondary|Percentage of Participants With Global Cure|Global cure is defined as the clinical cure of the initial CDI episode with no CDI recurrence through Week 12. Clinical cure is defined as no diarrhea [2 or fewer loose stools per 24 hours] for 2 consecutive days following completion of SOC therapy for the initial CDI episode in participants who received =< 14 day regimen.|12 weeks|The FAS population consisting of all randomized participants with participants excluded for the failure to receive infusion of study medication; for lack of a positive local stool test for toxigenic C. difficile; or for failure to receive protocol defined standard of care therapy within a 1 day window of the infusion.||Percentage of participants|||Number
684712|NCT01513239|Primary|Percentage of Participants With CDI Recurrence|CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive lab stool test (local or central) for toxigenic C. difficile after clinical cure of the initial CDI episode. Clinical cure is defined as no diarrhea [2 or fewer loose stools per 24 hours] for 2 consecutive days following completion of SOC therapy for the initial CDI episode in participants who received =< 14 day regimen.|12 weeks|The (Full Analysis Set) FAS population consisting of all randomized participants with participants excluded for the failure to receive infusion of study medication; for lack of a positive local stool test for toxigenic C. difficile; or for failure to receive protocol defined standard of care therapy within a 1 day window of the infusion.||Percentage of participants|||Number
684713|NCT01513148|Secondary|Temperature (Degrees C)|Change in superficial skin temperature (degrees C) from pre-treatment to 0 minute (immediately after treatment), and at 2 min intervals after treatment until 10 minutes post treatment occurs. Calculated difference scores at each time point = Temperature - Temperature at baseline. A positive variance int his calculation can be interpreted as being an increase from baseline or an increase in skin temperature|pre-treatment, 0 min, 2 min, 4 min, 6 min, 8 min and 10 min after treatment|||Degrees Celsius||Standard Deviation|Mean
684714|NCT01513148|Secondary|Negative Peak Latency (Milliseconds)|Change in negative peak latency (ms) from pre-treatment to 0 minute (immediately after treatment), and at 2 min intervals after treatment until 10 minutes post treatment occurs. Calculated difference scores at each time period = negative peak latency NPL - baseline NPL. A positive variance can be interpreted as being increase from baseline or a prolonged or slowed NPL.|pre-treatment, 0 min, 2 min, 4 min, 6 min, 8 min and 10 min after treatment|||ms||Standard Deviation|Mean
684715|NCT01513148|Primary|Nerve Conduction Velocity (Meters Per Second)|Change in nerve conduction velocity (m/s) from pre-treatment to 0 minute (immediately after treatment), and at 2 min intervals after treatment until 10 minutes post treatment occurs. Calculated difference scores at each time point = nerve conduction velocity (NCV) - baseline NCV. A positive variance represented an increase from baseline and is interpreted as being an increase or faster velocity.|pre-treatment, 0 min, 2 min, 4 min, 6 min, 8 min and 10 min after treatment|||m/s||Standard Deviation|Mean
684716|NCT01513122|Secondary|Mean Glucose Changes Over 48 Weeks as Measured by DXA Scan||May 2013|||mmol/L||95% Confidence Interval|Mean
684717|NCT01513122|Secondary|Mean Total Cholesterol Changes Over 48 Weeks as Measured by DXA Scan||May 2013|||mmol/L||95% Confidence Interval|Mean
684718|NCT01513122|Secondary|Mean Triglycerides Changes Over 48 Weeks as Measured by DXA Scan||May 2013|||mmol/L||95% Confidence Interval|Mean
684719|NCT01513122|Secondary|Mean Total Body Fat Changes Over 48 Weeks as Measured by DXA Scan||May 2013|||kg||95% Confidence Interval|Mean
684720|NCT01513122|Primary|Mean Limbs Fat Changes Over 48 Weeks as Measured by DXA Scan||May 2013|||percentage of limb fat change||95% Confidence Interval|Mean
684721|NCT01513122|Primary|Mean Bone Mineral Density Changes Over 48 Weeks as Measured by DXA Scan||May 2013|||percentage of BMD change||95% Confidence Interval|Mean
684726|NCT01512979|Secondary|Change From Baseline in HbA1c by Visit Over Time|HbA1c is measured as a percentage. The change from baseline is the HbA1c over time minus the baseline HbA1c. The model includes treatment, continuous baseline HbA1c in addition to week repeated within patient, week by baseline HbA1c interaction and week by treatment interaction.|Baseline, 6, 12, 18 and 24 weeks|Patients from PPCC (observed cases)||percent||Standard Error|Mean
684727|NCT01512979|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks of Treatment|The change from baseline is the FPG after 24 weeks minus the baseline FPG. Means are adjusted for treatment, continuous baseline HbA1c and continuous baseline fasting plasma glucose.|Baseline and 24 weeks|Patients from PPCC (LOCF)||mg/dL||Standard Error|Mean
684728|NCT01512979|Primary|Change From Baseline in HbA1c After 24 Weeks|HbA1c is measured as a percentage. The change from baseline is the Week 24 HbA1c minus the baseline HbA1c. Means are adjusted for treatment and continuous baseline HbA1c|Baseline and 24 weeks|Per Protocol completers cohort (PPCC): All patients randomised, treated with at least 1 dose of study drug, with a baseline HbA1c value without important protocol violations and who completed 24 weeks of treatment, were not treated with rescue medication and have an HbA1c measurement after 24 weeks of treatment.||percent||Standard Error|Mean
684729|NCT01512849|Primary|Effect of Renal Function on Percent Inhibition of Renal Glucose Reabsorption (RGR) of TA-7284|The percent inhibition of renal glucose reabsorption was calculated from renal glucose reabsorption (eGFR × plasma glucose AUC – urinary glucose excretion) on the preceding day and on the day of administration.|For 24 hours after each administration|||percent of RGR at baseline||95% Confidence Interval|Mean
684730|NCT01512849|Primary|Effect of Renal Function on Urinary Glucose Excretion of TA-7284||For 24 hours after each administration|||g||95% Confidence Interval|Mean
684731|NCT01512849|Primary|Effect of Renal Function on Area Under the Plasma Concentration-time Curve From Zero up to Infinity of TA-7284||For 72 hours after each administration|||ng･h/mL||Standard Deviation|Mean
684732|NCT01512849|Secondary|Clinical Laboratory Tests|Change from baseline in Clinical laboratory tests|For 72 hours after each administration||||||
684733|NCT01512849|Secondary|Vital Signs|Change from baseline in Vital signs (BP, PR and BT)|For 72 hours after each administration||||||
684734|NCT01512849|Secondary|12-lead Electrocardiogram (ECG)|Change from baseline in ECG parameters|For 72 hours after each administration||||||
684735|NCT01512849|Secondary|Adverse Events|Incidence and severity of AEs|Upto approximately 14 days after last administration||||||
684736|NCT01512849|Primary|Effect of Renal Function on Maximum Plasma Concentration of TA-7284||For 72 hours after each administration|||ng / mL||Standard Deviation|Mean
684737|NCT01512745|Secondary|Percentage of Participants With Adverse Events||30 months|||percentage of participants|||Number
684738|NCT01512745|Secondary|Objective Response Rate(ORR)|Objective Response Rate is defined as the proportion of patients with complete response(CR) or partial response(PR)|30 months|||percentage of participants|||Number
684739|NCT01512745|Secondary|Disease Control Rate(DCR)|Disease control is defined as the proportion of patients who had a best response rating of complete response, partial response, or stable disease, and lasted at least 4 weeks.|30 months|||percentage of participants|||Number
684740|NCT01512745|Primary|Overall Survival(OS)|Overall Survival of the Participants|30 months|||month||95% Confidence Interval|Median
684741|NCT01512745|Primary|Progression Free Survival(PFS)|Progression free survival of All the Evaluable Participants.Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of diameters of target lesions, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).|30 months|||month||95% Confidence Interval|Median
684742|NCT01512368|Secondary|Change From Baseline Fasting Glucose Acutely and at Two Weeks|Serum measurement of glucose was done at baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise|Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise|The sample size was calculated using the formula for means for two-tailed comparisons. According to our previous report, we expected a minimal change of 80 ng/l of FGF21 after two weeks of physical activity. Using a SD of 160 ng/l with an alfa of 0.05 and a study power of 80%, a total of 60 subjects were calculated.||mg/dL||Standard Deviation|Mean
684743|NCT01512368|Secondary|Change From Baseline Total Adiponectin Acutely and at Two Weeks|Serum measurement of total adiponectin was done at baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise|Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise|The sample size was calculated using the formula for means for two-tailed comparisons. According to our previous report, we expected a minimal change of 80 ng/l of FGF21 after two weeks of physical activity. Using a SD of 160 ng/l with an alfa of 0.05 and a study power of 80%, a total of 60 subjects were calculated.||ng/mL||Inter-Quartile Range|Median
684744|NCT01512368|Secondary|Change From Baseline Leptin Acutely and at Two Weeks|Serum measurement of leptin was done at baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise|Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise|The sample size was calculated using the formula for means for two-tailed comparisons. According to our previous report, we expected a minimal change of 80 ng/l of FGF21 after two weeks of physical activity. Using a SD of 160 ng/l with an alfa of 0.05 and a study power of 80%, a total of 60 subjects were calculated.||ng/mL||Inter-Quartile Range|Median
684745|NCT01512368|Secondary|Change From Baseline Epinephrine Acutely and at Two Weeks|Serum measurement of epinephrine was done at baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise.|Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise|The sample size was calculated using the formula for means for two-tailed comparisons. According to our previous report (5), we expected a minimal change of 80 ng/l of FGF21 after two weeks of physical activity. Using a SD of 160 ng/l with an alfa of 0.05 and a study power of 80%, a total of 60 subjects were calculated.||pg/mL||Inter-Quartile Range|Median
685109|NCT01507246|Primary|Health Economic Benefits - Total Cost of Hospitalization|Total cost of hospitalization until the time hospital discharge order is written or through Day 30, whichever is sooner.|Wound closure to time hospital discharge order written or Day 30, whichever is sooner.|per protocol||dollars||Standard Deviation|Mean
684746|NCT01512368|Secondary|Change From Baseline Free Fatty Acids (FFAs) Acutely and at Two Weeks|Serum measurement of free fatty acids (FFAs) was done at baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise.|Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise|The sample size was calculated using the formula for means for two-tailed comparisons. According to our previous report, we expected a minimal change of 80 ng/l of FGF21 after two weeks of physical activity. Using a SD of 160 ng/l with an alfa of 0.05 and a study power of 80%, a total of 60 subjects were calculated.||mg/dL||Inter-Quartile Range|Median
684747|NCT01512368|Primary|Change From Baseline Fibroblast Growth Factor 21 (FGF21) Acutely and at Two Weeks|Serum measurement of FGF21 using human ELISA kit was done at baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise.|Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise|The sample size was calculated using the formula for means for two-tailed comparisons. According to our previous report, we expected a minimal change of 80 ng/l of FGF21 after two weeks of physical activity. Using a SD of 160 ng/l with an alfa of 0.05 and a study power of 80%, a total of 60 subjects were calculated. All participants were analyzed.||ng/L||Inter-Quartile Range|Median
684748|NCT01512225|Secondary|Provision of Breast Milk at 6 Weeks Post Term Gestation|Provision of breast milk at 6 weeks post term gestation as primary source of nutrition|6 weeks post term gestation|||Participants|||Count of Participants
684749|NCT01512225|Secondary|Provision of Breast Milk at Term Gestation|provision of breast milk as the primary source of nutrition|term gestation|||Participants|||Count of Participants
684750|NCT01512225|Secondary|Mean Volume Change on the Volume of Milk From Day 15 to Day 28|change on the volume of milk from day 15 to day 28 between the two groups|day 15 and day 28|||millilitres||Full Range|Mean
684751|NCT01512225|Secondary|Mean Volume Change From Day 0 to Day 14|change on the volume of milk from day 0 to day 14 between the two groups|days 0 and 14|||millilitres||Full Range|Mean
684752|NCT01512225|Secondary|Mean Breast Milk Volumes on Day 28|Mean milk volumes between the two groups at 28 days of study intervention|day 0 and 28|||millilitres||Standard Deviation|Mean
684753|NCT01512225|Secondary|Mean Breast Milk Volumes on Day 14|Mean milk volumes between the two groups at 14 days of study intervention|Day 0 and day 14|||millilitres||Standard Deviation|Mean
684754|NCT01512225|Secondary|Increase in Breast Milk Volume on Day 28|Number of mothers who achieved 50% increase in milk volume on day 28|day 0 to day 28|||Participants|||Count of Participants
684755|NCT01512225|Primary|Increase in Breast Milk Production|The primary outcome is the difference in the proportion of women having a 50% increase in breast milk volume at the end of 14 days of treatment with domperidone compared to mothers receiving placebo (mean day 14 volume minus mean day 0 volume at entry).|Day 0 to day 14|||Participants|||Count of Participants
684756|NCT01512160|Secondary|Supine Pulse Rate|Supine pulse rate was measured in the brachial/radial artery for at least 30 seconds.|Screening, Day 0, 1 (pre-dose), 2, 10-14 (Follow-up)|Safety analysis set included all randomized participants who received at least 1 dose of study treatment. n=number of participants evaluable for this measure at specified time point.||beats per minute||Standard Deviation|Mean
684757|NCT01512160|Secondary|12-Lead Electrocardiogram (ECG) Parameter (Heart Rate)|Standard 12-lead ECG was performed after the participant has rested quietly for at least 10 minutes in a supine position. The time interval between consecutive heart beats (RR interval) was used to calculate heart rate.|Screening, Day 1, 2, 10-14 (Follow-up)|Safety analysis set included all randomized participants who received at least 1 dose of study treatment. n=number of participants evaluable for this measure at specified time points for each arm group respectively.||beats per minute||Standard Deviation|Mean
684758|NCT01512160|Secondary|12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)|Standard 12-lead ECG was performed after the participant has rested quietly for at least 10 minutes in a supine position. ECG intervals included PR interval (time between the onset of atrial depolarization and the onset of ventricular depolarization), QRS interval (represented ventricular depolarization) and QT interval (time corresponding to the beginning of depolarization to repolarization of the ventricles) corrected using Fridericia’s formula (QTcF = QT divided by cube root of RR interval).|Screening, Day 1, 2, 10-14 (Follow-up)|Safety analysis set included all randomized participants who received at least 1 dose of study treatment. n=number of participants evaluable for this measure at specified time points for each arm group respectively.||milliseconds||Standard Deviation|Mean
684759|NCT01512160|Secondary|Supine Systolic and Diastolic Blood Pressure (BP)|Supine systolic and diastolic BP was measured after the participant has been rested in the supine position for at least 5 minutes with the participant’s arm supported at the level of the heart, and recorded to the nearest millimeters of mercury (mmHg). The same arm and position and same size BP cuff was used throughout the study.|Screening, Day 0, 1 (pre-dose), 2, 10-14 (Follow-up)|Safety analysis set included all randomized participants who received at least 1 dose of study treatment. n=number of participants evaluable for this measure at specified time point.||mmHg||Standard Deviation|Mean
684760|NCT01512160|Secondary|Number of Participants With Clinically Significant Laboratory Test Abnormality|Hematology (hemoglobin, hematocrit, red blood cell count, platelets, leukocytes, total neutrophils, eosinophils, basophils, lymphocytes, monocytes); liver function (total bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, albumin, total protein); renal function (creatinine, blood urea nitrogen, uric acid, sodium, potassium, chloride, bicarbonate, calcium); urinalysis (urine pH, glucose, ketones, protein, blood, nitrite, leukocyte esterase), and clinical chemistry (glucose) were performed.|Baseline up to Day 10-14 (Follow-up)|Safety analysis set included all randomized participants who received at least 1 dose of study treatment.||participants|||Number
684761|NCT01512160|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Day 10 to 14.|Baseline up to Day 10-14 (Follow-up)|Safety analysis set included all randomized participants who received at least 1 dose of study treatment.||participants|||Number
684762|NCT01512160|Secondary|Area Under the Curve From Time Zero to 24 Hour [AUC (0-24)] of Ibuprofen|AUC (0-24)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose concentration.|0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose|PK analysis set included all randomized and treated participants for whom a PK sample was obtained and analyzed within the treatment period.||mcg*hr/mL||Standard Deviation|Geometric Mean
684763|NCT01512160|Secondary|Area Under the Curve From Time Zero to 6 Hour [AUC (0-6)] of Ibuprofen|AUC (0-6)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 6 hours post-dose concentration.|0 (pre-dose), 1, 2, 4, 6 hours post-dose|PK analysis set included all randomized and treated participants for whom a PK sample was obtained and analyzed within the treatment period.||microgram*hour per milliliter (mcg*h/mL)||Standard Deviation|Geometric Mean
684764|NCT01512160|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Ibuprofen||0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose|PK analysis set included all randomized and treated participants for whom a PK sample was obtained and analyzed within the treatment period.||hours||Full Range|Median
684765|NCT01512160|Secondary|Maximum Observed Plasma Concentration (Cmax) of Ibuprofen||0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose|PK analysis set included all randomized and treated participants for whom a PK sample was obtained and analyzed within the treatment period.||microgram per milliliter (mcg/mL)||Standard Deviation|Geometric Mean
684766|NCT01512160|Secondary|Area Under the Curve From Time Zero to 24 Hour [AUC (0-24)] of PF-04531083|AUC (0-24)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose concentration.|0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose|PK analysis set included all randomized and treated participants for whom a PK sample was obtained and analyzed within the treatment period.||ng*hr/mL||Standard Deviation|Geometric Mean
684767|NCT01512160|Secondary|Area Under the Curve From Time Zero to 6 Hour [AUC (0-6)] of PF-04531083|AUC (0-6)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 6 hours post-dose concentration.|0 (pre-dose), 1, 2, 4, 6 hours post-dose|PK analysis set included all randomized and treated participants for whom a PK sample was obtained and analyzed within the treatment period.||nanogram*hour per milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
684768|NCT01512160|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04531083||0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose|PK analysis set included all randomized and treated participants for whom a PK sample was obtained and analyzed within the treatment period.||hours||Full Range|Median
684769|NCT01512160|Secondary|Maximum Observed Plasma Concentration (Cmax) of PF-04531083||0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose|Pharmacokinetic (PK) analysis set included all randomized and treated participants for whom a PK sample was obtained and analyzed within the treatment period.||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
684770|NCT01512160|Secondary|Participant Satisfaction Questionnaire|Participant's response to 2 questions about “how satisfied or dissatisfied they were with the study medication for PR and overall performance (OP)” was obtained on a 5 point categorical scale, 1=very dissatisfied, 2=somewhat dissatisfied, 3=neither satisfied nor dissatisfied, 4=somewhat satisfied and 5=very satisfied.|6, 24 hours, prior to RM|FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration. Participants analyzed in this outcome for prior to rescue medication included only those participants who took rescue medication.||participants|||Number
684771|NCT01512160|Secondary|Participant Global Evaluation of Study Medication|Participant rated the study medication that they received during the study, at both the 6 hour and 24 hour observations or at time of rescue medication, whichever occurs first, by answering the following question on 6-point categorical scale: how would you rate the study medication you received for pain? 5=excellent, 4=very good, 3=good, 2=fair and 1=poor.|6, 24 hours, prior to RM|FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration. Participants analyzed in this outcome for prior to rescue medication included only those participants who took rescue medication.||participants|||Number
684772|NCT01512160|Secondary|Number of Participants With Rescue Medication|Participants who did not experience adequate pain relief after 90 minutes post-dose of study medication had received 2 tablets of acetaminophen 500 mg as rescue medication.|0 to 24 hours|FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration.||participants|||Number
684773|NCT01512160|Secondary|Time to First Use of Rescue Medication|Time to first use of rescue medication (2 tablets of acetaminophen 500 mg as starting dose) was calculated by subtracting time of first administration of study medication from the rescue medication administration time.|1.5 to 24 hours|FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration.||hours||90% Confidence Interval|Median
684774|NCT01512160|Secondary|Time to Onset of First Meaningful Pain Relief (PR)|Participants evaluated the time to first meaningful relief by stopping a second stopwatch labeled 'meaningful relief' at the moment they first began to experience meaningful relief.|0 to 24 hours|FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration.||hours||90% Confidence Interval|Median
684775|NCT01512160|Secondary|Time to Onset of First Perceptible Pain Relief (PR)|Participants evaluated the time to first perceptible relief by stopping a stopwatch labeled 'first perceptible relief' at the moment they first began to experience any relief.|0 to 24 hours|FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration.||hours||90% Confidence Interval|Median
684800|NCT01511536|Secondary|Phase 2: Pharmacokinetic of Cabazitaxel : Terminal Half-life (t 1/2z)||5 minutes before cabazitaxel infusion; at end of cabazitaxel infusion; 0.25 hours post-cabazitaxel infusion; any time between 1 to 4 hours, between 6 to 24 hours, between 48 to 96 hours post cabazitaxel infusion on Day 1-Cycle 1|Analysis was performed on PK population.||hour||Standard Deviation|Mean
685310|NCT01505114|Primary|Occurrence of Grade 3 or Higher Adverse Events (AEs)|participants had Occurrence of Grade 3 or higher adverse events (AEs)|Through Week 48|||Participants|||Count of Participants
684776|NCT01512160|Secondary|Total Pain Relief (TOTPAR) Score From 0 to 24 Hours|TOTPAR [24] was defined as the area under the pain relief (PR) curve through the 24 hours after dosing. Area under the curve (AUC) was calculated using the trapezoid rule with PR assumed to be 0 at time=0. PR was assessed on a 5-point categorical scale; 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete), at 15, 30, 45, minutes and at different time points during the study up to 24 hours post-dose. Total score range for TOTPAR [24]: 0 (worst) - 96 (best), higher value of TOTPAR indicated greater degree of PR.|0 to 24 hours|FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration. Missing TOTPAR values were imputed using LOCF.||units on a scale*hour||Standard Error|Least Squares Mean
684777|NCT01512160|Secondary|Summed Pain Intensity Difference (SPID) Score at 6 Hours and 24 Hours|Pain intensity was assessed on a categorical scale ranging from 0 (none), 1 (mild), 2 (moderate) and 3 (severe). PID was calculated as pain intensity at baseline minus pain intensity at the respective post-baseline visit. The SPID at 6 and 24 hours was derived by calculating the area under the PID effect curve through the first 6 or 24 hours post-dose respectively. The AUC was calculated using the trapezoid rule. Total score range: -6 (worst) to 18 (best) for SPID 0-6, and -24 (worst) to 72 (best) for SPID 0-24. Higher value of SPID indicated greater degree of pain relief.|0 to 6, 0 to 24 hours|FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration. Missing SPID values were imputed using LOCF.||units on a scale*hour||Standard Error|Least Squares Mean
684778|NCT01512160|Secondary|Time-specific Pain Intensity Difference (PID) Score|Pain intensity was assessed on a categorical scale ranging from 0 (none), 1 (mild), 2 (moderate) and 3 (severe). PID was calculated as pain intensity at baseline minus pain intensity at the respective post-baseline visit.|15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 8, 24 hours, prior to RM|FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration. n=number of participants evaluable for this measure at specified time point.||units on a scale||Standard Deviation|Mean
684779|NCT01512160|Secondary|Time-specific Pain Relief (PR) Score|PR was assessed on a 5-point categorical scale; 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete) at each relevant time points.|0, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 8, 24 hours, prior to rescue medication (RM)|FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration. n=number of participants evaluable for this measure at specified time point.||units on a scale||Standard Deviation|Mean
684780|NCT01512160|Secondary|Number of Participants With Peak Pain Relief (PPR)|PPR was defined as the highest PR score achieved at any time point during the evaluation period, prior to rescue medication. PR was assessed on a 5-point categorical scale; 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete).|0 to 24 hours|FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration.||participants|||Number
684781|NCT01512160|Primary|Total Pain Relief (TOTPAR) Score From 0 to 6 Hours|TOTPAR [6] was defined as the area under the pain relief (PR) curve through the first 6 hours after dosing. Area under the curve (AUC) was calculated using the trapezoid rule with PR was assumed to be 0 at time=0. PR assessed on a 5-point categorical scale; 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete), at 15, 30, 45, minutes and at different time points during the study up to 6 hours post-dose. Total score range for TOTPAR [6]: 0 (worst) - 24 (best), higher value of TOTPAR indicated greater degree of PR.|0 to 6 hours|Full analysis set (FAS) included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration. Missing PR values were imputed using last observation carried forward (LOCF).||units on a scale*hour||Standard Error|Least Squares Mean
684782|NCT01512108|Secondary|Change in FPG From Baseline to Week 52|Estimated mean change from baseline in FPG after 52 Weeks of treatment|Week 0, week 52|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial products and missing data were imputed using last observation carried forward (LOCF). One subject did not contribute to the statistical analysis at Week 52.||mmol/L||Standard Error|Mean
684783|NCT01512108|Secondary|Change in HbA1c From Baseline to Week 52|Estimated mean change in HbA1c from baseline after 52 Weeks of treatment|Week 0, week 52|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial products and missing data were imputed using last observation carried forward (LOCF). One subject did not contribute to the statistical analysis at Week 52.||percentage of glycosylated haemoglobin||Standard Error|Mean
684784|NCT01512108|Secondary|Number of Confirmed Hypoglycaemic Episodes|Confirmed hypoglycaemic episodes consisted of the pool of episodes of severe hypoglycaemia as well as minor hypoglycaemic episodes [An episode with symptoms consistent with hypoglycaemia with confirmation by plasma glucose <3.1 mmol/L (56 mg/dL) or full blood glucose <2.8 mmol/L (50 mg/dL) and which is handled by the subject himself or herself or any asymptomatic PG value <3.1 mmol/L (56 mg/dL) or full blood glucose value <2.8 mmol/L (50 mg/dL)] with a confirmed plasma glucose value of less than 3.1 mmol/L (56 mg/dL).|Week 0 to Week 52|Safety analysis set includes all subjects who received at least one dose of the trial product.||episodes|||Number
684785|NCT01512108|Primary|Incidence of Treatment Emergent Adverse Events (AEs)|Adverse events were defined as events occurring after administration of trial product and no later than 7 days after last day of treatment. Severe AEs: considerable interference with subject's daily activities. Moderate AEs: Marked symptoms, moderate interference with the subject's daily activities. Mild AEs: No or transient symptoms, no interference with the subject's daily activities. Serious AEs: AEs that resulted in any of the following: death, a life-threatening experience, hospitalization/prolongation of existing hospitalization, persistent/significant disability, and congenital anomaly.|Week 0 to Week 52 + 7 days|Safety analysis set included all subjects who received at least one dose of the trial product.||Events/100 years of patient exposure|||Number
684786|NCT01511978|Secondary|Self-assessment of LEMS-related Weakness, W-SAS|The last post-dose self-assessment of LEMS-related weakness from the withdrawal period with categories of much much weaker (-3), much weaker (-2), somewhat weaker (-1), about the same (0), somewhat stronger (1), much stronger (2), and much much stronger (3).|Participants were followed for up to 7 days|||units on a scale||Standard Deviation|Mean
684787|NCT01511978|Primary|Number of Participants With 30% or More Deterioration in Triple Timed Up & Go (3TUG) Test, Compared to Time-matched Baseline|"The 3TUG time obtained 2 hours after the last dose of the withdrawal period (i.e., at time of theoretical “peak drug effect”) was compared to the average time-matched 3TUG tests performed during 2 days of baseline observation prior to randomization.
The study endpoint was a change of more than 30% in the final post-dose 3TUG during the withdrawal period and was based on blinded readings of video recordings of 3TUG tests."|Baseline period (days 0, 1, 2); Randomized treatment period (starting with last dose of day 2, and days 3, 4, 5, and ending with first dose on day 6 when pre-randomization regimen was resumed, or rescue, if indicated sooner)|||Participants|||Count of Participants
684788|NCT01511939|Primary|Change From Baseline to Week 4 in Laboratory Results of Platelet Aggregation|Platelet Aggregation will be evaluated to determine if there is any significant effect of Pennsaid on coagulation parameters.|Baseline to Week 4|"For this analysis, the subject who was taking warfarin and aspirin was included in both the Pennsaid, warfarin group and the Pennsaid, aspirin and/or clopidogrel group, and the subject who was taking dabigatran and aspirin was included in both the Pennsaid, dabigatran group and the Pennsaid, aspirin and/or clopidogrel group."||Seconds||Full Range|Mean
684789|NCT01511939|Primary|Change From Baseline to Week 4 in Laboratory Results of Partial Thromboplastin Time (PTT)|PTT will be evaluated to determine if there is any significant effect of Pennsaid on coagulation parameters.|Baseline to Week 4|"Two subjects who completed the study were taking both an anticoagulant medication and aspirin. For this analysis, the subject who was taking warfarin and aspirin was included only in the Pennsaid, warfarin group, and the subject who was taking dabigatran and aspirin was included only in the Pennsaid, dabigatran group."||Seconds||Full Range|Mean
684790|NCT01511939|Primary|Change From Baseline to Week 4 in Laboratory Results of International Normalized Ratio (INR)|INR will be evaluated to determine if there is any significant effect of Pennsaid on coagulation parameters.|Baseline to Week 4|"Two subjects who completed the study were taking both an anticoagulant medication and aspirin. For this analysis, the subject who was taking warfarin and aspirin was included only in the Pennsaid, warfarin group, and the subject who was taking dabigatran and aspirin was included only in the Pennsaid, dabigatran group."||ratio||Full Range|Mean
684791|NCT01511939|Primary|Change From Baseline to Week 4 in Laboratory Results of Prothrombin Time (PT)|PT will be evaluated to determine if there is any significant effect of Pennsaid on coagulation parameters.|Baseline to week 4|"Two subjects who completed the study were taking both an anticoagulant medication and aspirin. For this analysis, the subject who was taking warfarin and aspirin was included only in the Pennsaid, warfarin group, and the subject who was taking dabigatran and aspirin was included only in the Pennsaid, dabigatran group."||seconds||Full Range|Mean
684792|NCT01511809|Secondary|Efficacy and Safety|"Proportion of pts with confirmed virological and treatment failure at w96. Change in CD4 cell counts.
Occurrence of viral resistance to atazanavir in pts with confirmed virologic failure.
Proportion of pts with adverse events, with ≥grade 2 adverse events or abnormal laboratory tests, proportion of pts with side effects leading to discontinuation.
Body fat redistribution and vertebral and femoral bone mineral density. Adherence changes; changes in HIV-associated neurocognitive disorders. Difference in levels of activated Tcells and pro-inflammatory cytokines between treatment groups."|week 96||||||
684793|NCT01511809|Primary|Proportion of Patients With Treatment Failure (TF)|Proportion of patients with treatment failure defined as having one of the following events: confirmed viral rebound (CVR) or treatment discontinuation for any cause. CVR was established when 2 consecutive viral load values (HIV-1 RNA)>50 copies/mL occurred within 2 weeks during follow-up. In case of CVR, patients treated with atazanavir/ritonavir monotherapy had to re-introduce their previous 2NRTIs (re-intensification) and, if not suppressed (HIV-1 RNA <50 copies /ml) after 12 weeks, discontinued from the study. Re-intensification was considered as treatment failure in the primary analysis conducted according to the intention-to-treat principle (intention-to-treat analysis with re-intensification equal failure, ITT=Failure) while it was not in the secondary analysis (intention-to-treat analysis with re-intensification equal success, ITT=Success).|Up to week 48|||percentage of patients|||Number
684794|NCT01511536|Secondary|Phase 2: Pharmacokinetic of Abiraterone : Concentration Observed Just Before Treatment Administration During Repeated Dosing at Steady State (Ctrough ss)||Pre abiraterone dose on Day 1 of Cycle 1|Analysis was performed on PK population. One participant was excluded from analysis due to aberrant data.||ng/mL||Standard Deviation|Mean
684795|NCT01511536|Secondary|Phase 2: Pharmacokinetic of Abiraterone : Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hours (AUC 0-24)|Area under the plasma concentration-time curve calculated using the trapezoidal method from time zero to 24 hours corresponding to abiraterone acetate dosing interval.|0 hour (before abiraterone administration); 1, 2, 4, 6, 8, 12, 24 hours post abiraterone administration on Day 1-Cycle 1|Analysis was performed on PK population. One participant was excluded from analysis due to aberrant data.||ng*h/mL||Standard Deviation|Mean
684796|NCT01511536|Secondary|Phase 2: Pharmacokinetic of Abiraterone : First Time to Reach Cmax (Tmax)||0 hour (before abiraterone administration); 1, 2, 4, 6, 8, 12, 24 hours post abiraterone administration on Day 1-Cycle 1|Analysis was performed on PK population. One participant was excluded from analysis due to aberrant data.||hour||Full Range|Median
684797|NCT01511536|Secondary|Phase 2: Pharmacokinetic of Abiraterone : Maximum Plasma Concentration Observed (Cmax)||0 hour (before abiraterone administration); 1, 2, 4, 6, 8, 12, 24 hours post abiraterone administration on Day 1-Cycle 1|Analysis was performed on PK population. One participant was excluded from analysis due to aberrant data.||ng/mL||Standard Deviation|Mean
684798|NCT01511536|Secondary|Phase 2: Pharmacokinetic of Cabazitaxel : Volume of Distribution at Steady State (Vss)||5 minutes before cabazitaxel infusion; at end of cabazitaxel infusion; 0.25 hours post-cabazitaxel infusion; any time between 1 to 4 hours, between 6 to 24 hours, between 48 to 96 hours post cabazitaxel infusion on Day 1-Cycle 1|Analysis was performed on PK population.||L/m^2||Standard Deviation|Mean
684799|NCT01511536|Secondary|Phase 2: Pharmacokinetic of Cabazitaxel : Total Plasma Clearance (CL)||5 minutes before cabazitaxel infusion; at end of cabazitaxel infusion; 0.25 hours post-cabazitaxel infusion; any time between 1 to 4 hours, between 6 to 24 hours, between 48 to 96 hours post cabazitaxel infusion on Day 1-Cycle 1|Analysis was performed on PK population.||L/h/m^2||Standard Deviation|Mean
685311|NCT01504997|Secondary|Incidence of Adverse Events||Participants will be followed for the duration of hospital stay, an expected average of 10 days||||||
685312|NCT01504997|Secondary|Completion Rate of Robot Assisted Surgery||During the surgery, an expected average of 5 hours||||||
684801|NCT01511536|Secondary|Phase 2: Pharmacokinetic of Cabazitaxel : Area Under the Plasma Concentration Versus Time Curve (AUC)|Area under the concentration-time curve calculated using the following equation: AUC = Plasma clearance (CL)/dose|5 minutes before cabazitaxel infusion; at end of cabazitaxel infusion; 0.25 hours post-cabazitaxel infusion; any time between 1 to 4 hours, between 6 to 24 hours, between 48 to 96 hours post cabazitaxel infusion on Day 1-Cycle 1|Analysis was performed on PK population.||ng*h/mL||Standard Deviation|Mean
684802|NCT01511536|Secondary|Phase 2: Pharmacokinetic of Cabazitaxel : Maximum Plasma Concentration Observed (Cmax)||5 minutes before cabazitaxel infusion; at end of cabazitaxel infusion; 0.25 hours post-cabazitaxel infusion; any time between 1 to 4 hours, between 6 to 24 hours, between 48 to 96 hours post cabazitaxel infusion on Day 1-Cycle 1|Analysis was performed on pharmacokinetic (PK) population which included all participants who received at least 1 treatment. Pre-dose samples from 3 participants of Phase 2, were above lower limit of quantification (LLOQ) (1.00 ng/mL). Hence, those participants were excluded from analysis.||ng/mL||Standard Deviation|Mean
684803|NCT01511536|Secondary|Phase 2: Overall Survival|Overall survival was defined as the time interval from the date of treatment start to the date of death due to any cause. In absence of confirmation of death, survival time was censored at the earlier of the last date the participant was known to be alive and the study cut-off date. Analysis was performed by Kaplan-Meier method.|From baseline up to death or study cut-off (maximum duration: 603 days)|Analysis was performed on efficacy/activity population.||months||95% Confidence Interval|Median
684804|NCT01511536|Secondary|Phase 2: Percentage of Participants With Objective Response|Objective response was defined as having complete response (CR) or Partial Response (PR) assessed by RECIST 1.1. CR was defined as disappearance of all target, non-target lesions; normalization of tumor marker level and all lymph nodes size was <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters).|Baseline, every 12 weeks there after until disease progression (maximum duration: 603 days)|Efficacy/activity population. Number of participants analyzed=participants with measurable disease at baseline.||percentage of participants||95% Confidence Interval|Number
684805|NCT01511536|Secondary|Phase 2: PSA Progression Free Survival|"Prostate-specific antigen progression-free survival was defined as the time interval between the date of treatment start and the date of either first documented PSA progression or death due to any cause, whichever was earlier. PSA was to be measured at baseline, every 3 weeks, throughout study period, until progression. PSA progression was defined as: -An increase of 25% above the nadir (at least 2 ng/mL), confirmed by a second PSA value at least 3 weeks apart, in participants who have achieved a ≥50% decline of PSA. -An increase in PSA by 25 % above the baseline level (at least 2 ng/mL), confirmed by a second PSA value at least 3 weeks apart, in participants who have not achieved a ≥50% decline of PSA.
Analysis was performed by Kaplan Meire method."|Baseline, every 3 weeks up to PSA progression (maximum duration: 603 days)|Analysis was performed on efficacy/activity population.||months||95% Confidence Interval|Median
684806|NCT01511536|Secondary|Phase 2: Objective Progression Free Survival (PFS)|"Objective PFS was defined as the time interval between the date of enrollment and the first occurrence of any of the events:
1) Radiological tumor progression (assessed using Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1) was defined as at least a 20 percent increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non target-lesions. in case of progressive disease (PD) diagnosed only on non target bone lesions on bone scan, PD was to be considered only in case of appearance of at least 2 new lesions on bone scan confirmed 6 weeks later by another bone scan, and at least the appearance of 2 new additional lesions. 2) Death due to any cause.
Analysis was performed by Kaplan-Meier method."|From baseline until radiological tumor or disease progression or death due to any cause, assessed up to Month 5|Analysis was performed on efficacy/activity population.||months||95% Confidence Interval|Median
684807|NCT01511536|Primary|Phase 2: Percentage of Participants With Prostate Specific Antigen (PSA) Response|Prostate specific antigen (PSA) response was defined as ≥50% decrease from baseline in serum PSA levels, confirmed at least 3 weeks later. Increases of any magnitude during the first 12 weeks were ignored in determining PSA response. PSA was to be measured at baseline, every 3 weeks, throughout study period, until progression. PSA progression was defined as: -An increase of 25% above the nadir (at least 2 ng/mL), confirmed by a second PSA value at least 3 weeks apart, in participants who have achieved a ≥50% decline of PSA. -An increase in PSA by 25 % above the baseline level (at least 2 ng/mL), confirmed by a second PSA value at least 3 weeks apart, in participants who have not achieved a ≥50% decline of PSA.|Baseline, every 3 weeks up to PSA progression (maximum duration: 603 days)|Analysis was performed on efficacy/activity population included all participants who had received at least 2 cycles of the study drug in Phase 2, and had a baseline and at least one post-baseline assessment for the efficacy variable of interest.||percentage of participants||95% Confidence Interval|Number
684808|NCT01511536|Primary|Phase 1: Maximally Tolerated Dose (MTD) of Cabazitaxel in Combination With Abiraterone Acetate|MTD was defined as highest dose level of cabazitaxel in combination with abiraterone acetate at which no more than 1 participant experienced dose limiting toxicities (DLT). DLT was defined as any of the following events related to study treatment: 1) Grade 3 or 4 non-hematological related adverse event with exception of Grade 3 fever without documented infection; Grade 3 nausea, vomiting, or diarrhea in the absence of effective maximal therapy; and Grade 3 hypersensitivity reaction in the absence of required premedication. 2) Hematological toxicity: Febrile neutropenia (fever of unknown origin ≥38.5°C with neutropenia Grade 3 or 4); Neutropenia Grade 4 lasting >7 days; Thrombocytopenia Grade 4 or Grade 3 complicated by hemorrhage. 3) Re-treatment delay of more than 2 weeks due to delayed recovery from a toxicity related to study treatment to baseline or ≤ Grade 1 (except for alopecia). Grades were based on National Cancer Institute CommonTerminology Criteria for Adverse Events v4.03.|Up to Cycle 2 of Phase 1 (up to 42 days)|Analysis was performed on DLT evaluable population defined as all participants who received the first 2 cycles, unless they discontinued the study drug during the first 2 cycles for a DLT.||mg/m^2|||Number
684809|NCT01511445|Secondary|Fusion Status|Dynamic flexion-extension plane film x-rays will be used to assess fusion at all four follow-up periods. The criteria for fusion are rotation motion less than or equal to four degrees and translation less than 1.25 mm. The final fusion judgement will be fusion status at 24 months or the last time point with flexion-extension data available.|3 mo., 6mo., 12 mo., 24 months|Patients with 24 month films||Participants|||Count of Participants
684810|NCT01511445|Primary|Neck Disability Index|The change in the Neck Disability Index compared to the pre-op value for each group will be compared. Neck disability index is a unitless measure from zero (no disability) to 100 (absolute disability). Change is calculated as the pre-op value minus the 24 month value. A negative difference indicates that the patient is more disabled at 24 months.|24 months post-op|Patients who had data from 24 month follow-up visit||units on a scale from 0 to 100||Standard Deviation|Mean
684811|NCT01511315|Secondary|Percentage of Patients Achieving PASI-75 at Weeks 12, 24, and 36|The Psoriasis Area and Severity Index (PASI) incorporates erythema, induration, and scale on a score of 0-4 weighted by percentage of body surface area involvement. PASI scores range from 0 to 72, with higher scores indicating worse disease. The percentage of patients achieving 75% reduction or better from the baseline PASI score in a designated time period has become the gold standard to measure the efficacy of psoriasis treatment options.|Weeks 12, 24, and 36|Only participants who completed the study were included in this analysis (n=32).||percentage of participants|||Number
684812|NCT01511315|Secondary|Percentage of Patients Achieving PGA of Clear or Almost Clear at Weeks 12, 24, and 36|The Physician Global Assessment (PGA) scoring system is used to assess the severity and extent of psoriasis using a score of 0-6 (clear, almost clear, minimal, moderate, severe, to very severe) averaged over all lesions.|Weeks 12, 24, and 36|Only participants who completed the study were included in this analysis (n=32).||percentage of participants|||Number
684813|NCT01511315|Secondary|Change in Dermatology Life Quality Index (DLQI) Over Time (at Weeks 12, 24, and 36) From Baseline|The DLQI is a 10-item self-reported survey, which addresses feelings, daily activities, leisure, work, school, personal relationships, and treatment. Each question item is worth 3 points (total maximum score of 30), with higher score representing greater QoL impairment.|Baseline, 12, 24, and 36 Weeks|Only participants who completed the study were included in this analysis (n=32).||units on a scale||Standard Error|Mean
684814|NCT01511315|Secondary|Change in Psoriasis Quality of Life – 12 Items (PQOL-12) Over Time (at Weeks 12, 24, and 36) From Baseline|The PQOL-12 is a 12-item psoriasis-specific validated PRO based entirely on the patient’s own assessment of their situation. The items were data-derived based on a series of population-based statistical studies and clinical trials conducted over a decade. The KMPI is one of the first tools used in dermatology to incorporate a validated PRO in critical medical decision-making. The scores range from 0-120 with higher scores indicating worse outcomes.|Baseline, 12, 24, and 36 Weeks|Only participants who completed the study were included in this analysis (n=32).||units on a scale||Standard Error|Mean
684815|NCT01511315|Secondary|Change in Work Productivity and Activity Impairment Scale (WPAI-PSO) Over Time at Week 36 From Baseline|The WPAI is a patient-reported quantitative assessment of the amount of absenteeism, presenteeism and daily activity impairment attributable to general health or a specific health problem. The WPAI:PSO was created specifically for administering to patients with psoriasis. WPAI surveys were analyzed based on published algorithms to determine the following: current employment status, absenteeism (percentage of time missed from work due to psoriasis), presenteeism (percentage reduced productivity at work due to psoriasis), total activity impairment (TAI, percentage impairment in activities other than work due to psoriasis), and total work productivity impairment (TWPI, total percentage of work impairment from both absenteeism and presenteeism due to psoriasis). Each WPAI score is expressed as impairment percentages (0-100), with higher scores representing greater impairment (worse outcomes)|Baseline, 36 Weeks|Only participants who completed the study were included in this analysis (n=32).||units on a scale||Standard Deviation|Mean
684816|NCT01511315|Secondary|Change in Psychological General Well-Being Scale (PGWB) Over Time (at Weeks 12 and 24) From Baseline|The PGWB is a self-administered validated psychometric instrument that measures a person’s emotional well-being. It is specifically designed to be suitable for assessing psychological well being in the general medical population as opposed to a psychiatric population. The 22 questions of the PGWB can be further divided into 6 domains: anxiety, depressed mood, positive well being, self-control, general health, and vitality. The PGWB is graded on a Likert scale, which is commonly used in psychometric questionnaires where the answers range from strongly agree to strongly disagree with gradations in between. Total scores range from 0 to 110, with higher scores indicating better psychological well being. This instrument has been validated and used in many countries on large samples of the general population and on various subsets of medical patients.|Baseline, 12 and 24 weeks|Only participants who completed the study were included in this analysis (n=32).||units on a scale||Standard Error|Mean
684817|NCT01511315|Primary|Improvement in Quality of Life Measured by Change in Psychological General Well-Being Scale (PGWB) at Week 36 From Baseline.|The PGWB is a self-administered validated psychometric instrument that measures a person’s emotional well-being. It is specifically designed to be suitable for assessing psychological well being in the general medical population as opposed to a psychiatric population. The 22 questions of the PGWB can be further divided into 6 domains: anxiety, depressed mood, positive well being, self-control, general health, and vitality. The PGWB is graded on a Likert scale, which is commonly used in psychometric questionnaires where the answers range from strongly agree to strongly disagree with gradations in between. Total scores range from 0 to 110, with higher scores indicating better psychological well being. This instrument has been validated and used in many countries on large samples of the general population and on various subsets of medical patients.|Baseline, 36 weeks|Only participants who completed the study were included in this analysis (n=32).||units on a scale||Standard Error|Mean
684818|NCT01511107|Secondary|The Distribution of Children for Whom Diaper Dermatitis Was Reported and Associated With Study Product|Diaper dermatitis is defined as dermatitis in the diaper area calling for prescription of a topical antifungal agent and is limited to events associated with study product.|Day 1 of administration of study product until day 16 for all episodes|The analysis was ITT. The number of participants equals the number of children randomized and eligible.||participants|||Number
684819|NCT01511107|Secondary|The Distribution of Children for Whom Protocol-Defined Diarrhea (PDD) Was Reported and Associated With Study Product|Protocol-defined diarrhea is defined as the occurrence of three or more watery stools in 1 day or two watery stools daily for 2 consecutive days and is limited to events associated with study product.|Day 1 of administration of study product until day 16 for all episodes|The analysis was ITT. The number of participants equals the number of children randomized and eligible.||participants|||Number
685313|NCT01504997|Secondary|Relapse Free Survival||5 years||||||
685314|NCT01504997|Secondary|Overall Survival||5 years||||||
684820|NCT01511107|Secondary|The Mean Acute Otitis Media - Severity of Symptom (AOM-SOS) Scores Days 6 to 14|"The AOM-SOS scale measures seven discrete items: tugging of ears, crying, irritability, difficulty sleeping, diminished activity, diminished appetite, and fever. The parent rated each of these symptoms in comparison with the child's usual state, as none, a little, or a lot, with corresponding scores of 0, 1, and 2, and recorded the ratings in a diary. Each set of ratings was summed to obtain an AOM-SOS score as a measure of symptom burden. Total scores range from 0 to 14, with higher scores indicating greater severity of symptoms. For instances in which the participant was declared a treatment failure, scores are included up to, but not including the day of the failure. Otherwise, scores day 6 to day 14 are included."|From day 6 of administration of study product until day 14 for all episodes|The analysis was ITT. The number of participants equals the number of children with at least one AOM-SOS score from day 6 of administration of study product to day 14. The scores were based on diaries completed at home by the child's parent.||AOM-SOS score||Standard Deviation|Mean
684821|NCT01511107|Secondary|The Mean Number of Days Systemic Antibiotics Were Received During the Entire Respiratory Season|Systemic antibiotics include the study product, Amoxicillin-Clavulanate, dispensed for either 10 or 5 days and various concomitant medications, i.e. Amoxicillin, Amox/Clav, Azithromycin, Cefdinir, Cefpodoxime, Ceftriaxone, Erythromycin, Trimethoprim-Sulfamethoxazole, Omnicef, Augmentin, Azithromycin, Cefazolin, Clarythromycin and Ciprofloxacin.|Day 1 of study entry until day 244. The respiratory season is October 1 - May 31, inclusive.|The analysis was ITT. The number of participants is equal to the number of children randomized & eligible.||days||Standard Deviation|Mean
684822|NCT01511107|Secondary|The Mean Rate, Per Month, of Protocol AOM Recurrences and Relapses Within the Entire Respiratory Season|"An episode of AOM occurring after Day 16 will be considered a recurrence. Subjects seen after day 10 and categorized as clinical success who return for an interim/sick visit before day 17 and are found to have AOM will be categorized as a relapse. For secondary outcome analyses, relapses are combined with recurrences.
The rate, expressed as a monthly rate, is calculated by dividing the total number of recurrences and relapses by the number of months of follow-up."|Day 1 of study entry until day 244. The respiratory season is October 1 - May 31, inclusive.|The analysis was ITT. The participants are randomized & eligible children having follow-up beyond day 16.||recurrences/relapses per months followed||Standard Deviation|Mean
684823|NCT01511107|Secondary|The Mean Rate, Per Month, of Protocol AOM Recurrences and Relapses Within 60 Days of Enrollment|"An episode of AOM occurring after Day 16 will be considered a recurrence. Subjects seen after day 10 and categorized as clinical success who return for an interim/sick visit before day 17 and are found to have AOM will be categorized as a relapse. For secondary outcome analyses, relapses are combined with recurrences.
The rate, expressed as a monthly rate, is calculated by dividing the total number of recurrences and relapses within 60 days of enrollment by the number of months of follow-up within 60 days of enrollment."|Day 1 of study entry until day 60.|The analysis was ITT. The participants are randomized & eligible children having follow-up beyond day 16.||recurrences/relapses per month||Standard Deviation|Mean
684824|NCT01511107|Secondary|The Distribution of Children With AOM Recurrences and Relapses Within the Entire Respiratory Season|An episode of AOM occurring after Day 16 will be considered a recurrence. Subjects seen after day 10 and categorized as clinical success who return for an interim/sick visit before day 17 and are found to have AOM will be categorized as a relapse. For secondary outcome analyses, relapses are combined with recurrences.|Day 1 of study entry until day 244. The respiratory season is October 1 - May 31, inclusive.|The analysis was ITT. The participants are randomized & eligible children completing the study.||participants|||Number
684825|NCT01511107|Secondary|The Distribution of Children With AOM Recurrences and Relapses Within 60 Days of Enrollment|An episode of AOM occurring after Day 16 will be considered a recurrence. Subjects seen after day 10 and categorized as clinical success who return for an interim/sick visit before day 17 and are found to have AOM will be categorized as a relapse. For secondary outcome analyses, relapses are combined with recurrences.|Day 1 of study entry until day 60.|The analysis was ITT. The participants are randomized & eligible children having follow-up greater than or equal to day 60.||participants|||Number
684826|NCT01511107|Secondary|The Distribution of AOM Recurrences for Which the Follow-up Nasopharyngeal (NP) Culture at the Day 12-14 Visit Yields a Nonsusceptible Haemophilus Influenzae (H Flu) Isolate|In the case of H flu, susceptible was defined as beta-lactamase-negative and ampicillin E test MIC ≤1 µg/mL; nonsusceptible was defined as either beta-lactamase-positive or beta-lactamase-negative and ampicillin E test MIC >1 µg/mL.|The day 12-14 visit following a recurrence. The mean day for this visit was 13.6.|The analysis was ITT. The number of participants is equal to the number of children randomized & eligible having a NP culture at the day 12-14 visit following an AOM recurrence.||recurrence|Recurrences||Number
684827|NCT01511107|Secondary|The Distribution of Children for Whom the Follow-up Nasopharyngeal (NP) Culture at the Day 12-14 Visit, Specific to the Index Episode, Yields a Nonsusceptible Haemophilus Influenzae (H Flu) Isolate|In the case of H flu, susceptible was defined as beta-lactamase-negative and ampicillin E test MIC ≤1 µg/mL; nonsusceptible was defined as either beta-lactamase-positive or beta-lactamase-negative and ampicillin E test MIC >1 µg/mL.|The day 12-14 visit specific to the index episode. The mean day for this visit was 13.4.|The analysis was ITT. The number of participants is equal to the number of children randomized & eligible having a NP culture at the day 12-14 visit following the index episode.||participants|||Number
684828|NCT01511107|Secondary|The Distribution of AOM Recurrences for Which the Follow-up Nasopharyngeal (NP) Culture at the Day 12-14 Visit Yields a Nonsusceptible Streptococcus Pneumoniae (S pn) Isolate|In the case of S pn, susceptibility to penicillin was determined as follows: When minimum inhibitory concentration (MIC) was available, susceptible was defined as MIC <0.1 µg/mL, intermediate as MIC 0.1 to 1 µg/mL, and resistant as MIC >1 µg/mL. When MIC was not available, susceptible was defined as showing oxacillin disk zone size >20 mm, intermediate as zone size 9 to 20 mm, and resistant as zone size ≤8 mm.|The day 12-14 visit following a recurrence. The mean day for this visit was 13.6.|The analysis was ITT. The number of participants is equal to the number of children randomized & eligible having a NP culture at the day 12-14 visit following an AOM recurrence.||recurrence|Recurrences||Number
684918|NCT01509638|Secondary|Patient Satisfaction With Postsurgical Analgesia|Responses to one question pertaining to patient satisfaction with postsurgical analgesia|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|Efficacy Analysis Set was 20 patients from Group 1 and 23 from Group 2 (planned surgery, no exclusion criteria, informed consent, Group 2 received EXPAREL)||participants|||Number
684829|NCT01511107|Secondary|The Distribution of Children for Whom the Follow-up Nasopharyngeal (NP) Culture at the Day 12-14 Visit, Specific to the Index Episode, Yields a Nonsusceptible Streptococcus Pneumoniae (S pn) Isolate|In the case of S pn, susceptibility to penicillin was determined as follows: When minimum inhibitory concentration (MIC) was available, susceptible was defined as MIC <0.1 µg/mL, intermediate as MIC 0.1 to 1 µg/mL, and resistant as MIC >1 µg/mL. When MIC was not available, susceptible was defined as showing oxacillin disk zone size >20 mm, intermediate as zone size 9 to 20 mm, and resistant as zone size ≤8 mm.|The day 12-14 visit specific to the index episode. The mean day for this visit was 13.4.|The analysis was ITT. The number of participants is equal to the number of children randomized & eligible having a NP culture at the day 12-14 visit following the index episode.||participants|||Number
684830|NCT01511107|Secondary|The Distribution of 6 Week Follow-up, Non-Illness Visits During the Respiratory Season at Which a Nonsusceptible Pathogen is Recovered|AOM pathogens are defined as Streptococcus pneumoniae (S pn) or Haemophilus Influenzae (H flu). In the case of S pn, susceptibility to penicillin was determined as follows: When minimum inhibitory concentration (MIC) was available, susceptible was defined as MIC <0.1 µg/mL, intermediate as MIC 0.1 to 1 µg/mL, and resistant as MIC >1 µg/mL. When MIC was not available, susceptible was defined as showing oxacillin disk zone size >20 mm, intermediate as zone size 9 to 20 mm, and resistant as zone size ≤8 mm. In the case of H flu, susceptible was defined as beta-lactamase-negative and ampicillin E test MIC ≤1 µg/mL; nonsusceptible was defined as either beta-lactamase-positive or beta-lactamase-negative and ampicillin E test MIC >1 µg/mL.|Day 1 of study entry until day 244. The respiratory season is October 1 - May 31, inclusive.|The analysis was ITT. The participants are randomized & eligible children with at least one follow-up, nonillness visit, with a nasopharyngeal (NP) culture which is either positive (+) for >=1 penicillin nonsusceptible pathogens or positive (+) only for >=1 penicillin susceptible pathogens or pathogen negative (-).||Visit|Visits||Number
684831|NCT01511107|Secondary|The Distribution of Children Whose Nasopharyngeal (NP) Isolates at Enrollment Are Pathogen Negative or Positive Only for at Least One Susceptible Pathogen Who Become Colonized With Nonsusceptible Pathogens at Any Time Over the Course of Follow-up|AOM pathogens are defined as Streptococcus pneumoniae (S pn) or Haemophilus Influenzae (H flu). In the case of S pn, susceptibility to penicillin was determined as follows: When minimum inhibitory concentration (MIC) was available, susceptible was defined as MIC <0.1 µg/mL, intermediate as MIC 0.1 to 1 µg/mL, and resistant as MIC >1 µg/mL. When MIC was not available, susceptible was defined as showing oxacillin disk zone size >20 mm, intermediate as zone size 9 to 20 mm, and resistant as zone size ≤8 mm. In the case of H flu, susceptible was defined as beta-lactamase-negative and ampicillin E test MIC ≤1 µg/mL; nonsusceptible was defined as either beta-lactamase-positive or beta-lactamase-negative and ampicillin E test MIC >1 µg/mL.|Day 1 of study entry until day 365|The analysis was ITT. The participants are randomized & eligible children having both a NP culture at enrollment that is either pathogen negative or positive only for >=1 susceptible pathogen and a NP culture at some time over the course of followup.||participants|||Number
684832|NCT01511107|Secondary|The Distribution of AOM Recurrences With a Nasopharyngeal (NP) Culture at Onset That is Positive for One or More Nonsusceptible Pathogens in Which the Follow-up NP Culture at Day 12-14 Yields a Nonsusceptible Pathogen|AOM pathogens are defined as Streptococcus pneumoniae (S pn) or Haemophilus Influenzae (H flu). In the case of S pn, susceptibility to penicillin was determined as follows: When minimum inhibitory concentration (MIC) was available, susceptible was defined as MIC <0.1 µg/mL, intermediate as MIC 0.1 to 1 µg/mL, and resistant as MIC >1 µg/mL. When MIC was not available, susceptible was defined as showing oxacillin disk zone size >20 mm, intermediate as zone size 9 to 20 mm, and resistant as zone size ≤8 mm. In the case of H flu, susceptible was defined as beta-lactamase-negative and ampicillin E test MIC ≤1 µg/mL; nonsusceptible was defined as either beta-lactamase-positive or beta-lactamase-negative and ampicillin E test MIC >1 µg/mL.|The end-of-treatment visit. The mean day for this visit was 13.4.|The analysis was ITT. The participants are randomized & eligible children having a NP culture at onset that is positive (+) for >=1 nonsusceptible pathogen & a NP culture at the day 12-14 visit which is either + for >=1 penicillin nonsusceptible pathogen OR pathogen negative (-) or + only for >=1 penicillin susceptible pathogen.||recurrence|Recurrences||Number
684833|NCT01511107|Secondary|The Distribution of Children With a Nasopharyngeal (NP) Culture at Enrollment That is Positive for One or More Nonsusceptible Pathogens in Which the Follow-up NP Culture at Day 12-14 Yields a Nonsusceptible Pathogen|AOM pathogens are defined as Streptococcus pneumoniae (S pn) or Haemophilus Influenzae (H flu). In the case of S pn, susceptibility to penicillin was determined as follows: When minimum inhibitory concentration (MIC) was available, susceptible was defined as MIC <0.1 µg/mL, intermediate as MIC 0.1 to 1 µg/mL, and resistant as MIC >1 µg/mL. When MIC was not available, susceptible was defined as showing oxacillin disk zone size >20 mm, intermediate as zone size 9 to 20 mm, and resistant as zone size ≤8 mm. In the case of H flu, susceptible was defined as beta-lactamase-negative and ampicillin E test MIC ≤1 µg/mL; nonsusceptible was defined as either beta-lactamase-positive or beta-lactamase-negative and ampicillin E test MIC >1 µg/mL.|The end-of-treatment visit. The mean day for this visit was 13.6.|The analysis was ITT. The participants are randomized & eligible children having both a NP culture at enrollment that is positive (+) for one or more nonsusceptible pathogens & a NP culture at the day 12-14 visit which is either + for >=1 penicillin nonsusceptible pathogen OR pathogen negative (-) or + only for >=1 penicillin susceptible pathogen.||participants|||Number
684850|NCT01510834|Secondary|Change in PSS From T1 to T3 (The Perceived Stress Scale [PSS] Cohen, Kamarck, & Mermelstein, 1983)|The PSS is the most widely used psychological instrument for measuring the perception of stress. It is a 10-item questionnaire that measures an individual's subjective evaluation the stressfulness of situations in their life in the past month. Items are designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives. The items are of a general nature and relatively free of content specific to any subpopulation. Internal consistency reliability of the PSS has been shown to be moderate (Cronbach alpha coefficient =.78) and that it has good test-re-test reliability. Scores can range from 0-40 as items are scored 1-4 points each. A higher score indicates more stress, so a negative change from baseline (T1)to 3-month follow-up (T3) is a better outcome.|Change in PSS score from baseline (T1) to final 3 mos. follow-up (T3)|All participants completing all 3 time points of the study.||units on a scale||Standard Deviation|Mean
685315|NCT01504997|Primary|The Incidence of Post-operative Intra-abdominal Infectious Complications||Participants will be followed for the duration of hospital stay, an expected average of 10 days|||participants||90% Confidence Interval|Number
684834|NCT01511107|Secondary|The Distribution of AOM Recurrences With a Nasopharyngeal (NP) Culture at Onset That is Positive Only for One or More Susceptible Pathogens in Which the Follow-up NP Culture at Day 12-14 Yields a Nonsusceptible Pathogen|AOM pathogens are defined as Streptococcus pneumoniae (S pn) or Haemophilus Influenzae (H flu). In the case of S pn, susceptibility to penicillin was determined as follows: When minimum inhibitory concentration (MIC) was available, susceptible was defined as MIC <0.1 µg/mL, intermediate as MIC 0.1 to 1 µg/mL, and resistant as MIC >1 µg/mL. When MIC was not available, susceptible was defined as showing oxacillin disk zone size >20 mm, intermediate as zone size 9 to 20 mm, and resistant as zone size ≤8 mm. In the case of H flu, susceptible was defined as beta-lactamase-negative and ampicillin E test MIC ≤1 µg/mL; nonsusceptible was defined as either beta-lactamase-positive or beta-lactamase-negative and ampicillin E test MIC >1 µg/mL.|The day 12-14 visit. The mean day for this visit was 13.9.|The analysis was ITT. The participants are randomized & eligible children having a NP culture at onset that is positive (+) only for one or more susceptible pathogens & a NP culture at the day 12-14 visit which is either + for >=1 penicillin nonsusceptible pathogen OR pathogen negative (-) or + only for >=1 penicillin susceptible pathogen.||recurrence|Recurrences||Number
684835|NCT01511107|Secondary|The Distribution of Children With a Nasopharyngeal (NP) Culture at Enrollment That is Positive Only for One or More Susceptible Pathogens in Which the Follow-up NP Culture at Day 12-14 Yields a Nonsusceptible Pathogen|AOM pathogens are defined as Streptococcus pneumoniae (S pn) or Haemophilus Influenzae (H flu). In the case of S pn, susceptibility to penicillin was determined as follows: When minimum inhibitory concentration (MIC) was available, susceptible was defined as MIC <0.1 µg/mL, intermediate as MIC 0.1 to 1 µg/mL, and resistant as MIC >1 µg/mL. When MIC was not available, susceptible was defined as showing oxacillin disk zone size >20 mm, intermediate as zone size 9 to 20 mm, and resistant as zone size ≤8 mm. In the case of H flu, susceptible was defined as beta-lactamase-negative and ampicillin E test MIC ≤1 µg/mL; nonsusceptible was defined as either beta-lactamase-positive or beta-lactamase-negative and ampicillin E test MIC >1 µg/mL.|The day 12-14 visit. The mean day for this visit was 13.2.|The analysis was ITT. The participants are randomized & eligible children having a NP culture at enrollment that is positive only for >=1 susceptible pathogen & a NP culture at the day 12-14 visit which is either positive (+) for >=1 penicillin nonsusceptible pathogen OR pathogen negative (-) or + only for >=1 penicillin susceptible pathogen.||participants|||Number
684836|NCT01511107|Secondary|The Distribution of AOM Recurrences With a Nasopharyngeal (NP) Culture at Onset That is Negative for AOM Pathogens in Which the Follow-up NP Culture at Day 12-14 Yields a Nonsusceptible Pathogen|AOM pathogens are defined as Streptococcus pneumoniae (S pn) or Haemophilus Influenzae (H flu). In the case of S pn, susceptibility to penicillin was determined as follows: When minimum inhibitory concentration (MIC) was available, susceptible was defined as MIC <0.1 µg/mL, intermediate as MIC 0.1 to 1 µg/mL, and resistant as MIC >1 µg/mL. When MIC was not available, susceptible was defined as showing oxacillin disk zone size >20 mm, intermediate as zone size 9 to 20 mm, and resistant as zone size ≤8 mm. In the case of H flu, susceptible was defined as beta-lactamase-negative and ampicillin E test MIC ≤1 µg/mL; nonsusceptible was defined as either beta-lactamase-positive or beta-lactamase-negative and ampicillin E test MIC >1 µg/mL.|The day 12-14 visit. The mean day for this visit was 13.4.|The analysis was ITT. The participants are randomized & eligible children having a NP culture at onset that is negative for both S pn and H flu and a NP culture at the day 12-14 visit which is either positive (+) for >=1 penicillin nonsusceptible pathogen OR pathogen negative (-) or + only for >=1 penicillin susceptible pathogen.||recurrence|Recurrences||Number
684837|NCT01511107|Secondary|The Distribution of Children With a Nasopharyngeal (NP) Culture at Enrollment That is Negative for AOM Pathogens in Which the Follow-up NP Culture at Day 12-14 Yields a Nonsusceptible Pathogen|AOM pathogens are defined as Streptococcus pneumoniae (S pn) or Haemophilus Influenzae (H flu). In the case of S pn, susceptibility to penicillin was determined as follows: When minimum inhibitory concentration (MIC) was available, susceptible was defined as MIC <0.1 µg/mL, intermediate as MIC 0.1 to 1 µg/mL, and resistant as MIC >1 µg/mL. When MIC was not available, susceptible was defined as showing oxacillin disk zone size >20 mm, intermediate as zone size 9 to 20 mm, and resistant as zone size ≤8 mm. In the case of H flu, susceptible was defined as beta-lactamase-negative and ampicillin E test MIC ≤1 µg/mL; nonsusceptible was defined as either beta-lactamase-positive or beta-lactamase-negative and ampicillin E test MIC >1 µg/mL.|The day 12-14 visit. The mean day for this visit was 13.3.|The analysis was ITT. The participants are randomized & eligible children having a NP culture at enrollment that is negative for both S pn and H flu and a NP culture at the day 12-14 visit which is either positive (+) for >=1 penicillin nonsusceptible pathogen OR pathogen negative (-) or + only for >=1 penicillin susceptible pathogen.||participants|||Number
684838|NCT01511107|Secondary|The Distribution of AOM Recurrences Categorized as Treatment Failure (TF) at or Before the Day 12-14 End-of-Treatment Visit|"Proportion of AOM recurrences resulting in treatment failure at or before the day 12-14 visit.
TF is defined as substantial persistence or worsening of symptoms specifically attributable to AOM, or of otoscopic signs of AOM, after 72 hours from the time of the recurrence, such that additional antimicrobial therapy is deemed advisable. If a parent/legal guardian is unwilling to continue the assigned study product regimen, the participant will be categorized as TF. Should a participant be administered another systemic antibiotic while taking study medication or prior to Day 16, the participant will be considered a TF. Clinical success is defined as complete or substantial resolution of symptoms specifically attributable to AOM for 48 hours and of otoscopic signs of acute inflammation (bulging of the TM or intense erythema), with or without persistence of middle-ear effusion, such that no additional antibiotic therapy is deemed advisable."|From 72 hours after the AOM recurrence was diagnosed until day 21 of the recurrence. The mean day for this visit was 13.3.|The analysis was ITT. The number of participants is equal to the number of children randomized & eligible who had a clinical assessment at or before the day 12-14 visit following an AOM recurrence.||recurrence|Recurrences||Number
684874|NCT01510457|Primary|Pain Visual Analogue Scale|Pain Visual Analogue Scale from 0-100 (0= no pain, and 100= most pain).|Collected at 2 visits over 11 weeks: Visit 1 and Visit 3.|||units on a 100mm pain scale||Standard Deviation|Mean
684875|NCT01510457|Primary|Center for Epidemiological Studies Depression Scale CESD-10 (CES-D 10)|The CES-D 10 is a 10-item questionnaire that has been validated for the assessment of depressive symptomatology. The Depression Scale is a scale with a sum score from 0 - 30, where 0 = no Depression and 30 = the most Depression.|Collected at 2 visits over 11 weeks: Visit 1 and Visit 3.|||units on the depression scale||Standard Deviation|Mean
684839|NCT01511107|Primary|The Distribution of Children Categorized as Treatment Failure (TF) at or Before the Day 12-14 End-of-Treatment Visit Specific to the Index Episode of AOM|"Proportion of children initially diagnosed with AOM who experience treatment failure at or before the day 12-14 visit.
TF is defined as substantial persistence or worsening of symptoms specifically attributable to AOM, or of otoscopic signs of AOM, after 72 hours from the time of randomization, such that additional antimicrobial therapy is deemed advisable. If a parent/legal guardian is unwilling to continue the assigned study product regimen, the participant will be categorized as TF. Should a participant be administered another systemic antibiotic while taking study medication or prior to Day 16, the participant will be considered a TF. Clinical success is defined as complete or substantial resolution of symptoms specifically attributable to AOM for 48 hours and of otoscopic signs of acute inflammation (bulging of the tympanic membrane (TM) or intense erythema), with or without persistence of middle-ear effusion, such that no additional antibiotic therapy is deemed advisable."|From 72 hours after randomization until day 21 of the index episode. The mean day for this visit was 13.2.|The analysis was intent to treat (ITT). The number of participants is equal to the number of children randomized & eligible who had a clinical assessment at or before the day 12-14 visit.||participants|||Number
684840|NCT01511016|Primary|Rate of Net Lipolysis|Rate of net lipolysis was measured in plasma samples by mass spectrometry following stable isotope infusions of labeled glycerol and palmitate|4 months after treatment|Subjects in each group were analyzed and compared after 4 months of treatment||mmol FFA/kg/h||Standard Error|Mean
684841|NCT01511016|Secondary|Insulin Levels After Oral Glucose Challenge.|An oral glucose tolerance test was performed to measure endogenous insulin response. This is not PD/PK in the sense that we are not studying the distribution or clearance of a drug. Rather, we are performing a clinical test of endogenous insulin response to glucose i.e., an endocrine test. Although multiple time points are used in this test, the outcome is a single value, i.e., an area-under-the-curve for insulin.|4 months after treatment.|Number of subjects remaining after 4 months of treatment.||microU/mL||Standard Error|Mean
684842|NCT01511016|Secondary|Glucose Levels After Glucose Challenge|An oral glucose tolerance test was performed. This is not PD/PK in the sense that we are not studying the distribution or clearance of a drug. Rather, we are performing a standard clinical test of glucose tolerance. i.e., a test for diabetes and pre-diabetes. Although multiple time points are used in this test, the outcome is a single value, either a blood glucose level after 2 hours or an area-under-the-curve. In this study we are reporting the area-under-the-curve.|4 months after treatment.|Number of subjects remaining after 4 months of treatment.||mg/dL||Standard Error|Mean
684843|NCT01511016|Secondary|Fasting Plasma Non-HDL-C|Fasting plasma non-HDL-cholesterol was calculated from measured total cholesterol and HDL cholesterol.|4 months after treatment.|Number of subjects in each group remaining after 4 months of treatment.||mg/dL||Standard Error|Mean
684844|NCT01511016|Secondary|Rates of Fatty Acid Oxidation|Rates of fatty acid oxidation were measured in breath samples following stable isotope infusions of 13C-labeled palmitate.|4 months after treatment|Number of subjects in each group remaining at the end of 4 months of treatment.||mmol FFA/kg/h||Standard Error|Mean
684845|NCT01511016|Primary|Rate of Total Lipolysis|Rate of total lipolysis was measured in plasma samples by mass spectrometry following stable isotope infusions of labeled glycerol and palmitate|4 months after treatment|Subjects in each group were analyzed and compared after 4 months of treatment.||mmol FFA/kg/h||Standard Error|Mean
684846|NCT01510912|Other Pre-specified|Mean Short Form-36 Mental Component Summary Scores at Week 52/Early Termination (ET) and Change From Baseline to Week 52/ET|The Short Form-36 is a validated 11-item health survey that assesses subject views about his/her functional health and well-being. The survey consists of 36 questions concerning daily or recent health-related activities and assesses 8 health domains using scaled scores. The mental component score is composed of a subset of the 8 health domains. Each scale is directly transformed into a 0 to 100 scale on the assumption that each question carries equal weight. A score of 0 is equal to maximum disability, and a score of 100 is equivalent to no disability.|Baseline to Week 52/Early Termination|||units on a scale||Standard Deviation|Mean
684847|NCT01510912|Other Pre-specified|Mean Short Form-36 Physical Component Summary Scores at Week 52/Early Termination (ET) and Change From Baseline to Week 52/ET|The Short Form-36 is a validated 11-item health survey that assesses subject views about his/her functional health and well-being. The survey consists of 36 questions concerning daily or recent health-related activities and assesses 8 health domains using scaled scores. The physical component score is composed of a subset of the 8 health domains. Each scale is directly transformed into a 0 to 100 scale on the assumption that each question carries equal weight. A score of 0 is equal to maximum disability, and a score of 100 is equivalent to no disability.|Baseline to Week 52/Early Termination|||units on a scale||Standard Deviation|Mean
684848|NCT01510912|Primary|Safety of Diclofenac 35 mg Capsules as Assessed by the Incidence of Adverse Events From Baseline to Week 52 or Early Termination|The safety of Diclofenac 35 mg capsules was assessed by the number of subjects with treatment-emergent adverse events (TEAEs), severe TEAEs, and serious adverse events.|Baseline to Week 52/Early Termination|||participants|||Number
684849|NCT01510834|Secondary|Change in PHQ-8 From T1-T3 (Patient Health Questionnaire [PHQ-8], Kroenke & Spitzer, 2002; Spitzer, Kroenke, & Williams, 1999)|The PHQ-9 is the self-administered depression module of the Patient Health Questionnaire that assesses common mental disorders. Eight of the 9 items in the scale are included in the Depression Prevention Assessment and is also known as the PHQ-8. Item 9, which assesses suicidality has been omitted in the online version. The PHQ-8 has been shown to have a sensitivity of 81% and specificity of 99% for scores 15 and above in diagnosing major depression, with a positive predictive value of 94%. Scores range from 0 to 24, with 10-14 indicating minor depression, 15-19 moderately severe major depression, and >19 indicating sever major depression. An initial drop of 5 points is considered adequate treatment response for 3 counseling sessions over 4-6 weeks. A higher score indicates more depression, so a reduction in score from baseline (T1) to 3-month follow-up (T3) is a better outcome.|Change in PHQ-8 score from baseline (T1) to final 3 mos. follow-up (T3)|Those participants who completed all 3 time points.||units on a scale||Standard Deviation|Mean
684876|NCT01510457|Primary|Pain Disability Index (PDI)|The PDI is a seven-item, validated instrument that assesses perceived disability in seven key life areas. It provides a total disability score, and is an indirect measure of self efficacy. The Pain Disability Scale is a scale from 0 - 70, where 0 = no Disability and 70 = the most Disability.|Collected at 2 visits over 11 weeks: Visit 1 and Visit 3.|||units on a disability scale||Standard Deviation|Mean
684851|NCT01510834|Secondary|Change in QOLS Score T1 to T3 (Quality of Life Scale [QOLS], Flanagan, 1978, 1982)|"The QOLS contains 16 items that represent five conceptual domains of quality of life. QOLS was developed with more consideration to cultural diversity and individual perspectives than other commonly used measures. It uses a unique 7-item Likert scale that allows responses regarding different aspects of life to range from delightful to terrible. It has been found to be internally consistent with alpha from .82 to .92 and showed high test-retest reliability over 3-weeks (r = 0.78 to r = 0 .84). The QOLS is scored by adding up the score on each item to yield a total score for the instrument. Scores can range from 16 to 112. Previous validation research showed that patients who participated in a treatment program and rated their symptoms as improved by 60% or gained on average 7 to 8 points on the QOLS total score. A higher QOLS score indicates better quality of life, therefore, a positive score change is a better outcome."|Change in QOLS score from baseline (T1) to final 3 mos. follow-up (T3)|Participants completing all 3 study time points.||units on a scale||Standard Deviation|Mean
684852|NCT01510834|Primary|Change in PCL-M Score (PTSD Symptom Checklist-Military [PCL-M], Weathers et al., 1993)|Developed by researchers at the VA National Center for PTSD, PCL is a self-report questionnaire that consists of 17 questions that map directly onto DSM-IV criteria for PTSD. Respondents are asked how often they have been bothered by each symptom in the past month on a 5-point Likert scale (1=not at all to 5=extremely). Previous research has shown internal consistency coefficients were high for the total scale (.97) and for each subscale (.92 - .93). Test-retest reliability over 2-3 days was shown to be .96. Scores can range from 17-85, with a score of 48 typically indicating PTSD in military populations. The National Center for PTSD recommends using 5 points as a minimum threshold for determining whether an individual has responded to treatment and 10 points as a minimum threshold for determining whether the improvement is clinically meaningful. A higher score indicates more PTSD symptoms, therefore, a score reduction from T1 to T3 is a better outcome than an increase.|Change in PCL-M score from baseline (T1) to final 3 mos. follow-up (T3)|57 completing all time points for intervention and assessment.||units on a scale||Standard Deviation|Mean
684853|NCT01510769|Secondary|Quality of Life|Proportion of subjects with an improvement from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) of at least 0.25 at Month 12. The HAQ-DI assesses a patient’s level of functional ability with items scores ranging from 0-3 with 0 being the least disability.|12 Months|Intent-to-Treat Population||Proportion of Subjects|||Number
684854|NCT01510769|Secondary|Complete or Partial Response of at Least One Tophus|Proportion of subjects with a best tophus response on at least 1 target tophus of complete (disappearance of at least 1 target tophus) or partial (≥ 50% decrease in the area of at least 1 target tophus) resolution by Month 12|12 Months|Intent-to-Treat Population||Proportion of Subjects|||Number
684855|NCT01510769|Secondary|Complete Resolution of at Least One Target Tophus|Proportion of subjects who experience complete resolution of at least 1 target tophus by Month 12|12 Months|Intent-to-Treat Population||Proportion of Subjects|||Number
684856|NCT01510769|Primary|Subjects With a Serum Urate (sUA) Level That is < 5.0 mg/dL by Month 6|Proportion of subjects with an sUA level that is < 5.0 mg/dL by Month 6|6 months, analysis after all subjects complete 12 months|Intent-to-Treat Population||Proportion of Subjects|||Number
684857|NCT01510756|Secondary|Safety and Tolerability|Frequency, severity and relatedness of adverse events|3 months|zero participants analyzed due to termination of study|||||
684858|NCT01510756|Secondary|To Determine the iwCLL-WG Defined Overall Response Rate (ORR) - Complete Response (CR) and Partial Responses (PR) to 3 Cycles of Sorafenib Therapy and Following the Completion of All Therapy.|A response assessment must be performed 2 months following completion of therapy to document responses, including a bone marrow if in clinical response (CR) and a computed tomography (or magnetic resonance imaging scan [MRI]) if initial imaging was abnormal or physical examination inconclusive.|Two months following completion of treatment with sorafenib according to iwCLL guidelines.|zero participants analyzed due to termination of study|||||
684859|NCT01510756|Primary|Overall Response Rate|Determination of absolute lymphocyte count (ALC), lymphadenopathy, splenomegaly, and/or marrow leukemia as measured by 4-color flow minimal residual disease (MRD) panel after 3 cycles of study treatment. (Decrease in absolute lymphocyte count by 50%, decrease in lymphadenopathy (sum of lymph node product) by 50%, decrease in splenomegaly by 50%, or decrease in leukemia infiltration of the bone marrow by 50%.)|3 months|Zero participants analyzed due to termination of study|||||
684860|NCT01510717|Primary|Mesopic Contrast Sensitivity With Glare at Day 120-180|Contrast sensitivity was assessed binocularly with the participant's best spectacle correction under mesopic conditions at a distance of 8 feet at spatial frequencies of 1.5, 3, 6, and 12 cpd using the Vector Vision CSV 1000 with a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity.|Day 120-180 from second eye implantation|The analysis population includes all participants with successful IOL implantation that had at least 1 postoperative visit, had no preoperative pathology or macular degeneration, and had no major protocol deviations at any time. Here n=number of participants with data for analysis.||logMAR||Standard Deviation|Mean
684861|NCT01510717|Primary|Mesopic Contrast Sensitivity Without Glare at Day 120-180|Contrast sensitivity was assessed binocularly with the participant's best spectacle correction under mesopic (dim lighting) conditions at a distance of 8 feet at spatial frequencies of 1.5, 3, 6, and 12 cycles per degree (cpd) using the Vector Vision CSV 1000 without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity.|Day 120-180 from second eye implantation|The analysis population includes all participants with successful IOL implantation that had at least 1 postoperative visit, had no preoperative pathology or macular degeneration, and had no major protocol deviations at any time. Here n=number of participants with data for analysis.||logMAR||Standard Deviation|Mean
684877|NCT01510457|Primary|Pain Anxiety Symptoms Scale (PASS)|Anxiety scores were collected at least two data points. The Pain Anxiety Symptoms Scale (PASS) is a scale from 0 - 100, where 0 = no anxiety and 100 = the most anxiety.|Collected at 2 visits over 11 weeks: Visit 1 and Visit 3.|||units on an anxiety scale||Standard Deviation|Mean
685316|NCT01504971|Secondary|Association of Each Endoscopic Finding With Treatment Effect of PPI|Treatment effect of PPI is assessed by changes of symptom score|2 month||||||
684862|NCT01510717|Primary|Photopic Contrast Sensitivity With Glare at Day 120-180|Contrast sensitivity was assessed binocularly with the participant's best spectacle correction under photopic (bright) conditions at a distance of 8 feet at spatial frequencies of 3, 6, 12, and 18 cycles per degree (cpd) using the Vector Vision CSV 1000 with a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity.|Day 120-180 from second eye implantation|The analysis population includes all participants with successful IOL implantation that had at least 1 postoperative visit, had no preoperative pathology or macular degeneration, and had no major protocol deviations at any time. Here n=number of participants with data for analysis.||logMAR||Standard Deviation|Mean
684863|NCT01510717|Secondary|Near Spectacle Independence Using SILVER Patient Reported Outcome (PRO) Questionnaire at Day 120-180|"Near Spectacle Independence was rated using SILVER, a new patient reported outcome questionnaire. The participant was asked, How often do you wear eyeglasses or contact lenses for seeing objects up close?"|Day 120-180 from second eye implantation|This analysis population includes all participants with successful IOL implantation in at least 1 eye with data present.||participants|||Number
684864|NCT01510717|Secondary|Overall Spectacle Independence Using SILVER Patient Reported Outcome (PRO) Questionnaire at Day 120-180|"Overall Spectacle Independence was rated using SILVER (Spectacle Independence Lens Vision Evaluation and Repurchase), a new patient reported outcome questionnaire. The participant was asked, How often do you wear eyeglasses or contact lenses overall?"|Day 120-180 from second eye implantation|This analysis population includes all participants with successful IOL implantation in at least 1 eye with data present.||participants|||Number
684865|NCT01510717|Secondary|Mean Photopic Monocular Distance Corrected Near VA at Standard Distance (40 cm) at Day 120-180|VA was tested monocularly (each eye separately) using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, ETDRS chart set at 40 cm on the nearpoint rod. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the primary eye.|Day 120-180 from second eye implantation|This analysis population includes all participants with successful IOL implantation in the primary eye.||logMAR|Participants|Standard Error|Mean
684866|NCT01510717|Secondary|Mean Photopic Monocular Best Corrected Distance VA (4 m) at Day 120-180|VA was tested monocularly (each eye separately) using the correction obtained from the manifest refraction and 100% contrast, ETDRS charts at a distance of 4 meters. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the primary eye.|Day 120-180 from second eye implantation|This analysis population includes all participants with successful IOL implantation in the primary eye.||logMAR|Participants|Standard Error|Mean
684867|NCT01510717|Primary|Photopic Contrast Sensitivity Without Glare at Day 120-180|Contrast sensitivity (ie, the ability to detect objects by distinguishing them from their background) was assessed binocularly with the participant's best spectacle correction under photopic (bright) conditions at a distance of 8 feet at spatial frequencies of 3, 6, 12, and 18 cycles per degree (cpd) using the Vector Vision CSV 1000 without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity.|Day 120-180 from second eye implantation|The analysis population includes all participants with successful IOL implantation that had at least 1 postoperative visit, had no preoperative pathology or macular degeneration, and had no major protocol deviations at any time. Here n=number of participants with data for analysis.||logMAR||Standard Deviation|Mean
684868|NCT01510717|Primary|Number of Cumulative and Persistent Adverse Events as Defined in IS EN ISO 11979-7:2006, up to Day 120-180|Cumulative and persistent adverse events were collected. This outcome measure was prespecified for the multifocal IOL.|Day 0 first operative eye visit, up to Day 120-180 from second eye implantation|This analysis population includes all participants with attempted IOL implantation in at least one eye (successful or aborted after contact with the eye).||adverse events|Participants||Number
684869|NCT01510717|Primary|Mean Photopic Monocular Distance Corrected VA (53 cm) at Day 120-180|Visual acuity (VA) was tested monocularly (each eye separately) using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart set at 53 centimeters (cm) on the nearpoint rod. VA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the primary eye.|Day 120-180 from second eye implantation|This analysis population includes all participants with successful IOL implantation in the primary eye.||logMAR|Participants|Standard Error|Mean
684870|NCT01510704|Primary|Post-operative Nausea or Vomiting||24 hours|ITT||participants|||Number
684871|NCT01510652|Secondary|Implant Duration|This measure reports the length (in time) of the implantation procedure. The measurement start at skin incision and stop at skin suture (so called skin-to-skin time) The total implant procedure duration time will be compared between the control and the treatment group.|Total duration of the implant procedure reported at the end of the procedure|The number of participants analyzed is the number of patients with implant data duration time available.||min||Standard Deviation|Mean
684872|NCT01510652|Secondary|Percentage of Cardiac Resynchronization Therapy Responders|Percentage of Cardiac Resynchronization Therapy (CRT) responders measured by a decrease of at least 10% of Left Ventricle End-Systolic Volume (LVESV)|Baseline and 6 months|The number of participants analyzed is the number of patients with echo data received for both baseline and 6 months follow up visits (and so comparable)||% of patients that are CRT responders|||Number
684873|NCT01510652|Primary|Lead Performance|"Percentage of patients with freedom from event (intra- and post-operative). Intra-operative events were defined as: need to use more than 1 left ventricular lead, need to change lead implant position, use of any device to actively fixate the lead, unsuccessful implant, due to phrenic nerve stimulation, high pacing threshold or lead instability.
Post-operative events were defined as any left ventricular lead related serious adverse device effect and CRT switched off."|6 months|||% of patients with freedom from event|||Number
685317|NCT01504971|Secondary|Association of Each Endoscopic Finding With pH Monitoring Result||1 month||||||
684878|NCT01510457|Primary|PamSys Actigraph Data|We used a body worn sensor (PAMSys™, Biosensics, LLC, MA)(25-27) embedded in a comfortable t-shirt at the sternal level. Participants wore the PAMSys after the visit for 48 hours. The device provides values related to subjects spontaneous physical activity including percentage of time standing and walking. These variables provide different indexes of participants’ level of activity and activity organization, and were reported by subjects with KOA pain as relevant.|48 hours after visit 3|||percentage of activity (over 48 hours)||Standard Error|Mean
684879|NCT01510457|Secondary|Daily Diary Entries With Pain, Fatigue and Functioning Scores Three Times a Day|Averages of daily diary outcomes were taken over the first and last week of the trial (week 1 and week 11) to compare pre and post treatment. diary was filled out 3 times a day and asked subjects to rate pain at rest, pain when walking, and fatigue on a scale 0-10 (0=none, and 10=the worst)|electronic diary entries with pain, fatigue and functioning scores were completed three times a day during week 1 and week 11|||units on a 0-10 NRS scale||Standard Deviation|Mean
684880|NCT01510457|Primary|McGill Pain Questionnaire – Short Form|The MPQ-SF is a well-validated pain measure that permits separation of the sensory and affective components of pain, which are added together to compute a total score. The scale ranges from 0-45 (0=no pain, 45=the most pain).|Collected at 2 visits over 11 weeks: Visit 1 and Visit 3.|||units on a pain scale||Standard Deviation|Mean
684881|NCT01510379|Secondary|Quantify the Amounts of Phenergan Used Between the Two Groups.||one week|||mg||Standard Deviation|Mean
684882|NCT01510379|Primary|Comparison of Postoperative Nausea and Vomiting Scores Between Groups Treated With a ReletexTM Device and Those Without the Device.|Post-operative Nausea and Vomiting (PONV) Likert scale, 0-10 (0=no PONV, 10=worst PONV).|24 hours|||units on a scale||Standard Deviation|Mean
684883|NCT01510327|Secondary|Definite + Probable Stent Thrombosis Rate Based on Academic Research Consortium (ARC) Definition|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days).|>30 days-1 year|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
684884|NCT01510327|Secondary|Definite + Probable Stent Thrombosis Rate Based on Academic Research Consortium (ARC) Definition|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days).|>24 hours-30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
684885|NCT01510327|Secondary|Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days).|24 hours|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
684886|NCT01510327|Secondary|Target Lesion Revascularization (TLR)|TLR is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
684887|NCT01510327|Secondary|Target Vessel Revascularization (TVR)|TVR is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
684888|NCT01510327|Secondary|Myocardial Infarction (MI) Related to the Target Vessel|New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase (CK) MB or troponin >normal; if no new Q-waves total CK levels >3× normal (peri-percutaneous coronary intervention [PCI]) or >2× normal (spontaneous) with elevated CK-MB or troponin >3× normal (peri-PCI) or >2× normal (spontaneous) plus at least one of the following: ECG changes indicating new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium, or new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5× normal|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
684889|NCT01510327|Secondary|All Death|Number of participants no longer alive|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants who died|||Number
684890|NCT01510327|Secondary|Total Blood Clearance - Everolimus (CL)|Venous blood draw up to 24 hours prior to implantation of the first study stent (predose time point), 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours after completion of implantation of the last study stent.|Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours|Analysis groups have ≥3 subjects. Everolimus concentrations declined rapidly in all subjects; CL could be inaccurately determined for a subset of samples; determined by extrapolation of terminal phase. Concentrations not above detection limit in the terminal phase for enough time points for most subjects to accurately determine CL value.||L/h||Standard Deviation|Mean
684891|NCT01510327|Secondary|Terminal Phase Half-life (t1/2) Everolimus|Venous blood draw up to 24 hours prior to implantation of the first study stent (predose time point), at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours after completion of implantation of the last study stent.|Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours|Analysis groups have ≥3 subjects. Everolimus concentrations declined rapidly in all subjects; half-life could be inaccurately determined for a subset of samples; determined by extrapolation of terminal phase. Concentrations not above detection limit in the terminal phase for enough time points for most subjects to accurately determine half-life.||Hours||Standard Deviation|Mean
684892|NCT01510327|Secondary|Time of Occurrence of Maximum Everolimus Concentration (Tmax)|Venous blood draw up to 24 hours prior to implantation of the first study stent (predose time point) and at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours after completion of implantation of the last study stent|Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours|Analysis groups reported here had 3 or more subjects.||hours||Standard Deviation|Mean
684893|NCT01510327|Secondary|Area Under the Concentration Versus Time Curve (AUC 0-infinity) Everolimus|Venous blood draw up to 24 hours prior to implantation of the first study stent (predose time point), 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours after implantation of the last study stent.|Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours|Analysis groups have ≥3 subjects. Everolimus concentrations declined rapidly in all subjects; AUC0-∞ could be inaccurately determined for a subset of samples. AUC0-∞ determined by extrapolation of terminal phase. Concentrations not above detection limit in the terminal phase for enough time points for most subjects to accurately determine AUC0-∞.||ng*hr/mL||Standard Deviation|Mean
684894|NCT01510327|Secondary|Area Under the Concentration Versus Time Curve (AUC 0-24), Everolimus|Venous blood draw up to 24 hours prior to implantation of the first study stent (predose time point) and at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours after completion of implantation of the last study stent|Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours|The analysis groups reported here had 3 or more subjects.||ng*hr/mL||Standard Deviation|Mean
684895|NCT01510327|Secondary|Area Under the Concentration Versus Time Curve (AUC 0-t) Everolimus|Venous blood draw up to 24 hours prior to implantation of the first study stent (predose time point) and at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours after completion of implantation of the last study stent; t is the last time at which concentration can be quantified|Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours|The analysis groups reported here had 3 or more subjects.||ng*hr/mL||Standard Deviation|Mean
684896|NCT01510327|Primary|Maximum Observed Everolimus Blood Concentration (Cmax)|Venous blood draw up to 24 hours prior to implantation of the first study stent (predose time point) and at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours after completion of implantation of the last study stent|Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours|The analysis groups reported here had 3 or more subjects.||ng/mL||Standard Deviation|Mean
684897|NCT01510158|Secondary|Tophus|Proportion of subjects with ≥ 1 target tophus at Baseline who experience complete resolution of at least 1 target tophus by Month 12|12 Months|||Proportion of Subjects|||Number
684898|NCT01510158|Secondary|Gout Flares|Mean rate of gout flares requiring treatment for the 6-month period from the end of Month 6 to the end of Month 12|12 Months|||Gout Flares||Standard Deviation|Mean
684899|NCT01510158|Primary|Proportion of Subjects With an sUA Level That is < 6.0 mg/dL||6 Months, analysis after all subjects complete 12 months|Intent-to-Treat Population||Proportion of Subjects|||Number
684900|NCT01510145|Secondary|Percentage of Subjects Who Reach Target IOP (≤18 mmHg)|IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.|Week 12|This anaylysis population includes all subjects who instilled at least one drop of study product and who had primary endpoints measures available for at least one on-therapy study visit.||percentage of patients|||Number
684901|NCT01510145|Primary|Change in Intraocular Pressure (IOP) at 12 Weeks From Prior Therapy (Baseline)|IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.|Baseline, Week 12|This analysis population includes all patients who instilled at least one drop of study product and who had primary endpoints measures available for at least one on-therapy study visit.||mmHg||Standard Deviation|Mean
684902|NCT01509807|Secondary|Experienced Any Health Problems or Changed in Health Since Hospital Discharge|Yes, if patient experienced any health problems or changes in health since hospital discharge; no, if patient did not experience health problems or changes since hospital discharge; not reported, if applicable.|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|The Efficacy Analysis Set had 11 participants in Group 1 and 16 participants in Group 2. The Efficacy Analysis Set was defined as those patients who underwent the planned surgery, did not meet any of the intraoperative exclusion criteria, and had provided informed consent. In addition, the Group 2 patients must have received study drug (EXPAREL).||participants|||Number
684903|NCT01509807|Secondary|Contact or Attempt to Contact Surgeon/Doctor to Discuss Recovery After Surgery|Yes, if patient contacted or attempted to contact surgeon/doctor to discuss recovery after surgery; no, if patient did not contact or attempt contact; not reported if applicable.|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|The Efficacy Analysis Set had 11 participants in Group 1 and 16 participants in Group 2. The Efficacy Analysis Set was defined as those patients who underwent the planned surgery, did not meet any of the intraoperative exclusion criteria, and had provided informed consent. In addition, the Group 2 patients must have received study drug (EXPAREL).||participants|||Number
684917|NCT01509638|Secondary|Patient Discharged From Hospital for at Least 3 Days|Yes, if patient discharged from hospital for at least 3 days; no, if patient not discharged from hospital for at least 3 day; not reported, if applicable.|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|Efficacy Analysis Set was 20 patients from Group 1 and 23 from Group 2 (planned surgery, no exclusion criteria, informed consent, Group 2 received EXPAREL)||participants|||Number
685318|NCT01504971|Secondary|Association of Each Endoscopic Finding With Symptom Score|Symptom score is assessed by a self-reported questionnaire|1 month||||||
684904|NCT01509807|Secondary|Make Unplanned VIsit(s) With Any Healthcare Providers|Yes, if patient made an unplanned visit with a healthcare provider; no, if patient did not make an unplanned visit with a healthcare provider; not reported, if applicable|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|The Efficacy Analysis Set had 11 participants in Group 1 and 16 participants in Group 2. The Efficacy Analysis Set was defined as those patients who underwent the planned surgery, did not meet any of the intraoperative exclusion criteria, and had provided informed consent. In addition, the Group 2 patients must have received study drug (EXPAREL).||participants|||Number
684905|NCT01509807|Secondary|Readmission to Hospital Since Discharge|Yes, if patient was readmitted to hospital since discharge; no, if patient was not readmitted to hospital since discharge; not reported, if appropriate.|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|The Efficacy Analysis Set had 11 participants in Group 1 and 16 participants in Group 2. The Efficacy Analysis Set was defined as those patients who underwent the planned surgery, did not meet any of the intraoperative exclusion criteria, and had provided informed consent. In addition, the Group 2 patients must have received study drug (EXPAREL).||participants|||Number
684906|NCT01509807|Secondary|Patient Discharged From the Hospital for at Least 3 Days|Yes, if patient was discharged from the hospital for at least 3 days; no, if patient was not discharged for at least 3 day; not reported if appropriate|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|The Efficacy Analysis Set had 11 participants in Group 1 and 16 participants in Group 2. The Efficacy Analysis Set was defined as those patients who underwent the planned surgery, did not meet any of the intraoperative exclusion criteria, and had provided informed consent. In addition, the Group 2 patients must have received study drug (EXPAREL).||participants|||Number
684907|NCT01509807|Secondary|Patient Satisfaction With Postsurgical Analgesia|Responses to question pertaining to patient satisfaction with postsurgical analgesia described by total percentage indicating satisfied or extremely satisfied.|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|The Efficacy Analysis Set had 11 participants in Group 1 and 16 participants in Group 2. The Efficacy Analysis Set was defined as those patients who underwent the planned surgery, did not meet any of the intraoperative exclusion criteria, and had provided informed consent. In addition, the Group 2 patients must have received study drug (EXPAREL).||percentage of patients|||Number
684908|NCT01509807|Primary|Health Economic Benefit - Length of Stay|Time from completion of wound closure until hospital discharge written or through Day 30, whichever was sooner|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|The Efficacy Analysis Set had 11 participants in Group 1 and 16 participants in Group 2. The Efficacy Analysis Set was defined as those patients who underwent the planned surgery, did not meet any of the intraoperative exclusion criteria, and had provided informed consent. In addition, the Group 2 patients must have received study drug (EXPAREL).||days||Full Range|Median
684909|NCT01509807|Secondary|Incidence of Opioid-related Adverse Events|Incidence of opioid-related adverse events defined as somnolence, respiratory depression, hypoventilation, hypoxia, dry mouth, nausea, vomiting, constipation, sedation, confusion, pruritus, urinary retention, and postoperative ileus.|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|The Efficacy Analysis Set had 11 participants in Group 1 and 16 participants in Group 2. The Efficacy Analysis Set was defined as those patients who underwent the planned surgery, did not meet any of the intraoperative exclusion criteria, and had provided informed consent. In addition, the Group 2 patients must have received study drug (EXPAREL).||events|||Number
684910|NCT01509807|Primary|Health Economic Benefits - Total Cost of Hospitalization|1) Total cost of hospitalization until the time hospital discharge order is written or through Day 30, whichever is sooner.|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|The Efficacy Analysis Set had 11 participants in Group 1 and 16 participants in Group 2. The Efficacy Analysis Set was defined as those patients who underwent the planned surgery, did not meet any of the intraoperative exclusion criteria, and had provided informed consent. In addition, the Group 2 patients must have received study drug (EXPAREL).||dollars||Standard Deviation|Mean
684911|NCT01509807|Primary|Total Opioid Burden|Total opioid consumed (IV and PO) postsurgically until hospital discharge order is written or through Day 30, whichever is sooner.|Wound closure to time the discharge order is written or Day 30, whichever is sooner|The Efficacy Analysis Set had 11 participants in Group 1 and 16 participants in Group 2. The Efficacy Analysis Set was defined as those patients who underwent the planned surgery, did not meet any of the intraoperative exclusion criteria, and had provided informed consent. In addition, the Group 2 patients must have received study drug (EXPAREL).||mg morphine equivalent||Standard Deviation|Mean
684912|NCT01509664|Primary|Gross Weekly Purchasing of Fruits and Vegetables|Gross weekly purchasing of fruits and vegetables from the discounted items list in $|week|||$||Standard Error|Mean
684913|NCT01509638|Secondary|Time to First Opioid Administration|Time in hours to first opioid administration|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|Efficacy Analysis Set was 20 patients from Group 1 and 23 from Group 2 (planned surgery, no exclusion criteria, informed consent, Group 2 received EXPAREL)||hours||Full Range|Median
684914|NCT01509638|Secondary|Experienced Health Problems or Changes in Health Since Hospital Discharge|Yes, if experienced health problems or changes in health; No, if did not experience health problems or changes in health; not reported, if applicable|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|Efficacy Analysis Set was 20 patients from Group 1 and 23 from Group 2 (planned surgery, no exclusion criteria, informed consent, Group 2 received EXPAREL)||participants who answered yes|||Number
684915|NCT01509638|Secondary|Contact or Attempted to Contact Surgeon/Doctor to Discuss Recovery After Surgery|Yes, if contacted or attempted to contact; No, if did not contact and did not attempt to contact; not reported, if applicable.|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|Efficacy Analysis Set was 20 patients from Group 1 and 23 from Group 2 (planned surgery, no exclusion criteria, informed consent, Group 2 received EXPAREL)||participants who answered yes|||Number
684916|NCT01509638|Secondary|Patient Made Unplanned Visit(s) With Any Healthcare Providers|Yes, if patient made unplanned visit(s); No, if patient did not make unplanned visits; not reported, if applicable|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|Efficacy Analysis Set was 20 patients from Group 1 and 23 from Group 2 (planned surgery, no exclusion criteria, informed consent, Group 2 received EXPAREL)||participants who answered yes|||Number
684919|NCT01509638|Secondary|Incidence of Opioid-related Adverse Events|Incidence of opioid-related adverse events defined as somnolence, respiratory depression, hypoventilation, hypoxia, dry mouth, nausea, vomiting, constipation, sedation, confusion, pruritus, urinary retention, and postoperative ileus.|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery). Efficacy Analysis Set was 20 patients from Group 1 and 23 from Group 2 (planned surgery, no exclusion criteria, informed consent, Group 2 received EXPAREL)||number of events||Standard Deviation|Mean
684920|NCT01509638|Primary|Health Economic Benefit|Length of stay (LOS), recorded in hours, defined as the time of completion of the wound closure until the hospital discharge order is written or through Day 30, whichever is sooner.|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery). Efficacy Analysis Set was 20 patients from Group 1 and 23 from Group 2 (planned surgery, no exclusion criteria, informed consent, Group 2 received EXPAREL)||days||Full Range|Median
684921|NCT01509638|Primary|Health Economic Benefits|Total cost of hospitalization until the time the discharge order is written or through Day 30, whichever is sooner.|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery). Efficacy Analysis Set was 20 patients from Group 1 and 23 from Group 2 (planned surgery, no exclusion criteria, informed consent, Group 2 received EXPAREL)||dollars||Standard Deviation|Mean
684922|NCT01509638|Primary|Total Opioid Burden|Total opioid consumed (IV and PO) postsurgically until hospital discharge order is written or through Day 30, whichever is sooner.|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner|22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery). Efficacy Analysis Set was 20 patients from Group 1 and 23 from Group 2 (planned surgery, no exclusion criteria, informed consent, Group 2 received EXPAREL)||mg morphine equivalent||Standard Deviation|Mean
684923|NCT01509625|Secondary|Response to Treatment With Fulvestrant in Terms of PFS in a Subgroup of Patients With Elevated Ki-67 and With Low Ki-67|To assess the response to treatment with fulvestrant (Faslodex®) at the 500 mg/month and LD-500 dose in terms of PFS in a subgroup of patients with elevated ki-67 (greater than or equal to 20%) and with low ki-67 and to compare both groups|22 months|We identified 272 patientes for the study but nine subjects were ineligible due to lack of information, leaving to 263 evaluable patients. There were no information regarding tumor ki67 expresion in 121 patients.||month||95% Confidence Interval|Median
684924|NCT01509625|Secondary|Response to Treatment With Fulvestrant in Terms of PFS in Subgroups of Patients With Her-2 Overexpression and Those Who do Not Over-express Her-2|"To assess the response to treatment with fulvestrant at the 500 mg/month and LD 500 dose in terms of PFS in subgroups of patients with her-2 overexpression (+++ by immunohistochemistry or FISH positive) and those who do not over-express her-2 and to compare both groups.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or TC: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; PD (progressive disease)> = 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion or the appearance of new lesions; Clinical Benefit = CR + PR+ Stable Disease (not progression of the disease for 24 or more weeks)."|22 months|We identified 272 patientes for the study but nine subjects were ineligible due to lack of information, leaving to 263 evaluable patients. There were no information regarding HER2 status in 31 patients.||month||95% Confidence Interval|Median
684925|NCT01509625|Secondary|Response to Treatment With Fulvestrant in Terms of PFS in a Subgroup of Patients After a First-line Hormonal Therapy Prior and in Subgroup of Patients After Two or More Prior Lines of Hormonal Therapy|To assess the response to treatment with fulvestrant (Faslodex®) at the 500 mg/month and LD-500 dose in terms of PFS in a subgroup of patients after a first-line hormonal therapy prior and in subgroup of patients after two or more prior lines of hormonal therapy|22 months|We identified 272 patientes for the study but nine subjects were ineligible due to lack of information, leaving to 263 evaluable patients. There were 5 patients that have not received previous tamoxifen or an aromatases inhibitor, so they are not included in one of these two groups.||month||95% Confidence Interval|Median
684926|NCT01509625|Secondary|Response to Treatment With Fulvestrant in Terms of PFS in a Subgroup of Patients With Visceral Metastases and Without Visceral Metastases|"Response to treatment with fulvestrant at the 500 mg/month and LD 500 dose in terms of PFS in a subgroup of patients with visceral metastases and without visceral metastases.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or TC: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; PD (progressive disease)> = 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion or the appearance of new lesions; Clinical Benefit = CR + PR+ Stable Disease (not progression of the disease for 24 or more weeks)."|22 months|We identified 272 patientes for the study but nine subjects were ineligible due to lack of information, leaving to 263 evaluable patients.||month||95% Confidence Interval|Median
684927|NCT01509625|Secondary|Number of Participants With Adverse Events||22 months|||percentage of patients||95% Confidence Interval|Number
684928|NCT01509625|Secondary|Duration of Clinical Benefit|"Response to treatment with fulvestrant in terms of Duration of the Clinical Benefit.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or TC: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; PD (progressive disease)> = 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion or the appearance of new lesions; Clinical Benefit = CR + PR+ Stable Disease (not progression of the disease for 24 or more weeks)."|22 months|For the study of the duration of the clinical benefit, only the patients that get a clinical benefit could be analyzed (this is the reason becasuse the number of participants analyzed was 140)||month||95% Confidence Interval|Median
684929|NCT01509625|Secondary|Overall Survival|Response to treatment with fulvestrant in terms of Overall Survival|22 months|||month||95% Confidence Interval|Median
684930|NCT01509625|Secondary|Clinical Benefit Rate|Response to treatment with fulvestrant in terms of Clinical Benefit Rate. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or TC: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; PD (progressive disease)> = 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion or the appearance of new lesions; Clinical Benefit = CR + PR+ Stable Disease (not progression of the disease for 24 or more weeks).|22 months|||percentage of patients|||Number
684931|NCT01509625|Primary|Progression Free Survival|"Response to treatment with fulvestrant (Faslodex®) in terms of Progression Free Survival.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% or more increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions."|22 months|||month||95% Confidence Interval|Median
684932|NCT01509586|Primary|Quit Attempts and Abstinence|"% of study participants making a quit attempt or staying abstinent from smoking during the study
Notes:
Floating abstinence: Any 7-day period of non-smoking, ever within study. PPA: point-prevalence abstinence"|From study enrollment through end of one-year follow up|||percentage of participants|||Number
684933|NCT01509105|Secondary|Number of Participants Discontinued Due to Adverse Events|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|Baseline up to 28 days after last dose of study vaccination (13 Months)|Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up.||participants|||Number
684934|NCT01509105|Secondary|Number of Participants With Outcome in Response to Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Outcome of an AE was response to a question answered by those participants who had at least 1 AE: ‘Is the adverse event still present?’ as ‘yes’, ‘unknown’ or ‘no-resolved'.|Baseline up to 28 days after last dose of study vaccination (13 Months)|"Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, N signifies those participants who had at least 1 adverse event."||participants|||Number
684935|NCT01509105|Secondary|Number of Participants With Adverse Events (AEs) by Severity|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An AE was assessed according to severity; mild (not causing any significant problem, dose adjustment not required), moderate (caused problem that does not interfere significantly with usual activities or the clinical status, dose adjustment needed due to adverse event) and severe (caused problem that interferes significantly with usual activities or the clinical status, study drug stopped due to adverse event).|Within 7 days after Vaccination 1, 2, 3 and within 28 days after Vaccination 4|"Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, n signifies those participants who were evaluable at specified time points."||participants|||Number
684936|NCT01509105|Secondary|Duration of Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Duration of AE is the total time from onset of adverse event till the event is resolved in participants who had at least 1 AE.|Baseline up to 28 days after last dose of study vaccination (13 Months)|"Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, N signifies those participants who had at least 1 adverse event."||days||Standard Deviation|Mean
684937|NCT01509105|Primary|Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 28 Days After Vaccination 4|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Within 28 days after Vaccination 4|Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, “N” signifies those participants who were evaluable for this outcome measure.||participants|||Number
684938|NCT01509105|Primary|Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 3|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Within 7 days after Vaccination 3|Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, “N” signifies those participants who were evaluable for this outcome measure.||participants|||Number
684939|NCT01509105|Primary|Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 2|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Within 7 days after Vaccination 2|Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, “N” signifies those participants who were evaluable for this outcome measure.||participants|||Number
684953|NCT01509053|Secondary|Clinical Global Impression of Improvement (CGI-I) Score|"The participant's overall improvement was rated for each participant using the CGI-I scale. The investigator rated the participant's total improvement by answering the following question: Compared to his/her condition at baseline (prior to randomization), how much has the patient changed? using an 8-point scale where 0=not assessed, 1=very much improved to 7=very much worse. Lower scores indicated improvement."|Baseline, Week 24|Due to the low number of enrolled patients and the sponsor's early termination of the study, this endpoint was not evaluated.|||||
684940|NCT01509105|Primary|Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 1|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Within 7 days after Vaccination 1|Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, “N” signifies those participants who were evaluable for this outcome measure.||participants|||Number
684941|NCT01509105|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 28 Days After Vaccination 4|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.|Within 28 days after Vaccination 4|Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, “N” signifies those participants who were evaluable for this outcome measure.||participants|||Number
684942|NCT01509105|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 3|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.|Within 7 days after Vaccination 3|Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, “N” signifies those participants who were evaluable for this outcome measure.||participants|||Number
684943|NCT01509105|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 2|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.|Within 7 days after Vaccination 2|Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, “N” signifies those participants who were evaluable for this outcome measure.||participants|||Number
684944|NCT01509105|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 1|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.|Within 7 days after Vaccination 1|Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, “number of participants analyzed” (N) signifies those participants who were evaluable for this outcome measure.||participants|||Number
684945|NCT01509079|Secondary|Vitamin D Binding Protein Genotype||Baseline||||||
684946|NCT01509079|Secondary|Bone Mineral Density||Change from screen to 6 months||||||
684947|NCT01509079|Secondary|Change in Steady State Concentrations of Serum Anastrazole and Letrozole|Difference in steady state concentrations in plasma from baseline to 6 months|baseline to 6 months|Only study participants with baseline and 6 month blood samples available were analyzed||mg/L||Standard Deviation|Mean
684948|NCT01509079|Secondary|Serum Estradiol Concentrations||baseline and 6 months|only participants whose serum was obtained at both time points are included||pg/ml||Standard Error|Geometric Mean
684949|NCT01509079|Secondary|Average Percent Adherence to Vitamin D Interventio|adherence measured with pill counts for the vitamin D at predesignated study timepoints: baseline (after run-in), 3 months and 6 months|average for all study ppts for: screening to baseline; baseline to 3 months; 3 month to 6 months|||% of adherence for each treatment arm|||Number
684950|NCT01509079|Secondary|Change in PROMIS Physical Functioning Questionnaire|PROMIS measures physical functioning on the short form and higher scores reflect better physical functioning with 10 questions on daily activities of life on a Likert scale ranging from 5 (no problem performing activity) to 1 (cannot do activity). Range on this measure is from 50 (best)-10 (worst).|baseline to 6 months|only data from participants with measures at both time points are included||units on a scale||Standard Deviation|Mean
684951|NCT01509079|Primary|Change in Hand Grip Strength||baseline to 6 months|only data from participants that were collected at both time points is included||pounds||Standard Deviation|Mean
684952|NCT01509079|Primary|Change in Musculoskeletal Symptom Sub-scale on the Breast Cancer Prevention Trial Symptom Scale|The MS subscale is a self-reported measure on a scale of 0 to 4, with lower score indicating less arthralgia/myalgia|baseline to 6 months|Only participants who provided data at both time points are included||units on a scale||Standard Deviation|Mean
684954|NCT01509053|Secondary|Clinical Global Impression of Severity (CGI-S) Score|"The severity of illness for each participant was rated using the CGI-S scale. The investigator answered the following question: Considering your total clinical experience with this particular population, how mentally ill is the patient at this time? using an 8-point scale where 0=not assessed to 7=among the most extremely ill patients."|Baseline, Week 24|Due to the low number of enrolled patients and the sponsor's early termination of the study, this endpoint was not evaluated.|||||
684955|NCT01509053|Secondary|Change From Baseline in PANSS Positive and Negative Subscale Scores|The PANSS Positive Subscale consisted of 7 symptom constructs rated on a 7-point scale where 1=absence of symptoms to 7=extremely severe symptoms. The total score on the Positive Subscale ranged from 7 to 49 with a higher score indicating more severe symptoms. The PANSS Negative Subscale consisted of 7 symptom constructs rated on a 7-point scale where 1=absence of symptoms to 7=extremely severe symptoms. The total score on the Negative Subscale ranged from 7 to 49 with a higher score indicating more severe symptoms. A Negative change from Baseline indicated improvement.|Baseline, Week 24|Due to the low number of enrolled patients and the sponsor's early termination of the study, this endpoint was not evaluated.|||||
684956|NCT01509053|Secondary|Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score|The PANSS consisted of 3 subscales with a total of 30 symptom constructs each rated on a 7-point scale where 1=absence of symptoms to 7=extremely severe symptoms. The Positive Subscale consisted of 7 positive symptom constructs with a possible subscale score of 7 to 49, the Negative Subscale consisted of 7 negative symptom constructs with a possible subscale score of 7 to 49 and the General Psychopathology Subscale consisted of 16 symptom constructs for a possible subscale score of 16 to 112. The PANSS Total Score ranged from 30 (best) to 210 (worst; indicating more severe symptoms). A Negative change from Baseline indicated improvement.|Baseline, Week 24|Due to the low number of enrolled patients and the sponsor's early termination of the study, this endpoint was not evaluated.|||||
684957|NCT01509053|Primary|Comparison of Inpatient Psychiatric Hospitalization Rates|The comparison of inpatient psychiatric hospitalization rates (proportion of patients with ≥1 inpatient psychiatric hospitalizations) between the retrospective period Months 4-6 (Weeks-12 to -24) while on oral standard of care antipsychotic treatment and the prospective period Phase B Months 4-6 (Weeks 12 to 24) after the switch to aripiprazole IM depot.|Retrospective period Months 4-6; Prospective period Months 4-6|Due to the low number of enrolled patient and the sponsor's early termination of the study, the primary efficacy endpoint was not evaluated.|||||
684958|NCT01509040|Secondary|Clinical Safety Outcomes; Number of Participants With Clinical Diagnoses|Clinical diagnoses of cerebral bleeding, stroke, bleeding requiring transfusion or surgical intervention, rearrest, pulmonary edema, rib or sternal fractures, internal thoracic or abdominal injuries as noted in the discharge summary|Discharge|||participants|||Number
684959|NCT01509040|Secondary|Unexpected Adverse Device Events (UADE)|These will be defined as any unexpected adverse effect on health or safety or any unexpected life-threatening problem caused by, or associated with, a device, if that effect or problem was not previously identified in nature, severity, or degree of incidence in this investigation plan or application which will be submitted to the Food and Drug Administration (including a supplementary plan or application), or any other unexpected serious problem associated with a device. The death or neurological impairment of an individual patient will not be considered an adverse event in this study.|48 hours|||participants|||Number
684960|NCT01509040|Secondary|Safety Outcome, Number of Participants With STEMI, Radiographic Pulmonary Edema, or Arrhythmia|"ST-Elevation Myocardial Infarction- ECG criteria and biomarker criteria for acute infarction.
Radiographic Pulmonary Edema- radiographic presence of alveolar or interstitial edema, bilateral pleural effusions, cardiomegaly or venous congestion.
Arrhythmia- other than sinus rhythm observed after randomization. Arrhythmia requiring treatment- rhythm with subsequent use of an antiarrhythmic drug or electrical therapy observed after randomization.
Arrhythmia with cardiovascular instability- any rhythm with cardiovascular instability as determined by the DSMB, observed after randomization."|48 hours|||Participant|||Number
684961|NCT01509040|Secondary|Expected Adverse Event|"Device-Related Hematoma at insertion site, vessel perforation, wound infection, deep venous thrombosis or pulmonary embolism.
Device Failure Mechanical failure Hypertension- SBP>160 mmHg, or DBP >120 mmHg. Hypotension- SBP<60 mmHg. Hypervolemia- CVP > 12 cm. Hypovolemia- CVP < 2 cm. Hypokalemia- serum potassium concentration < 3.5 mmol/L. Alkalosis- serum bicarbonate > 32 mmol/L. Hyperglycemia- serum glucose > 240 mg/dL. Hypophosphatemia- serum phosphate concentration < 0.8 mmol/L. Hypocalcemia- serum ionized calcium < 2.2 mmol/L. Lactic acidosis- serum lactate > 6 mmol/L."|48 hours|||participants|||Number
684962|NCT01509040|Secondary|Time Interval From 911 Call to Patient Death|This will be described for all hospitalized patients as a measure of morbidity after resuscitation.|1 year|||Days||Inter-Quartile Range|Mean
684963|NCT01509040|Secondary|Number of Hospital Days|This will be described for all hospitalized patients as a measure of morbidity after resuscitation.|6 months|||days||Inter-Quartile Range|Mean
684964|NCT01509040|Secondary|Ejection Fraction|This will be assessed by standard transthoracic echocardiographic methods 48 hours after enrollment in control and intervention patients|48 hours|||percentage||Inter-Quartile Range|Mean
684965|NCT01509040|Secondary|Shock|This will be defined as systolic blood pressure < 65 at the end of any four hour period during the initial 48 hours of enrollment in control and intervention patients.|48 hours|||participants|||Number
684966|NCT01509040|Secondary|Use of Pressors and Inotropes|This includes use of dopamine, dobutamine, epinephrine, nesiritide, norepinephrine, or phenylephrine during the first 48 hours from enrollment.|48 hours|||participants|||Number
684967|NCT01509040|Secondary|Total Volume Intravenous Fluid Infused|This will be defined as the volume of fluid (in mL) infused during the first 48 hours from enrollment.|48 hours|||mL||Inter-Quartile Range|Mean
684968|NCT01509040|Secondary|Clearance of Inflammatory Mediators|Venous blood samples will be obtained periodically after randomization, processed, stored, then tested for serum cytokine levels.|48 hours|The outcome was not assessed.|||||
684969|NCT01509040|Secondary|Enrollment|This will be defined as the proportion of eligible patients who are randomized.|12 hours|||participants|||Number
684970|NCT01509040|Primary|Intervention Compliance|Intervention Compliance will be defined as the proportion of intervention patients who are alive and undergo hemofiltration (HF) for at least 80% of 48 hours from randomization.|48 hours|||participants|||Number
684971|NCT01508936|Secondary|Participants With a Positive Anti-Reslizumab Antibody Status During Study|"Counts of participants with a positive anti-drug antibody (ADA) response during treatment is offered for the experimental treatment arm. Blood samples were collected for determination of ADAs before study drug infusion at screening, weeks 8 and 16 or early withdrawal. Serum samples from patients who were treated with reslizumab were analyzed for ADA by Teva (Teva Biopharmaceuticals USA, Rockville, MD) using a validated homogeneous solution-based bridging enzyme-linked immunosorbent assay (ELISA).
Endpoint =week 16 or early withdrawal.
Counts represent the total number of participants at each time point with a positive immunogenicity test, and not 'new' participants with a positive test. An overall status of positive includes participants who had a positive ADA at any time point."|Screening (Week -3), Weeks 8 and 16|Safety analysis set; antibody assessments reported for active treatment arm only.||participants|||Number
684972|NCT01508936|Secondary|Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Electrocardiogram (ECG) Abnormalities|Counts represent the number of participants with potentially clinically significant ECG abnormalities as assessed by the investigator.|Week 16 or endpoint|Safety analysis set||participants|||Number
684973|NCT01508936|Secondary|Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Vital Signs Values|"Data represents participants with potentially clinically significant (PCS) vital sign values during any of the treatment period exams.
Significance criteria
Heart rate - high: >100 and increase of >= 30 beats/minute (bpm)
Sitting systolic blood pressure - high: >160 and increase of >=30 mmHg
Sitting systolic blood pressure - low: <90 and decrease of >=30 mmHg
Sitting diastolic blood pressure - high: >100 and increase of >=12 mmHg
Sitting diastolic blood pressure - low: <50 and decrease of >=12 mmHg
Body temperature - high: >100.5° Fahrenheit or 38.1° Celsius and increase of >2°
Body temperature - low: <96.5° Fahrenheit or <35.8° Celsius"|Week 4 to Week 28|Safety analysis set of participants with assessments||participants|||Number
684974|NCT01508936|Secondary|Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Abnormal Lab Values|"Data represents participants with potentially clinically significant (PCS) abnormal serum chemistry, hematology, and urinalysis values during any of the lab tests conducted during the treatment period.
Significance criteria:
Blood urea nitrogen: >=10.71 mmol/L
Creatinine: >=177 μmol/L
Uric acid: M>=625, F>=506 μmol/L
Aspartate aminotransferase: >=3*upper limit of normal (ULN). Normal range is 10-43 U/L
Alanine aminotransferase: >=3*ULN. Normal range is 10-40 U/L
GGT = gamma-glutamyl transpeptidase: >= 3*ULN. Normal range is 4-49 U/L.
Total bilirubin: >=34.2 μmol/L
Creatinine phosphokinase: >5*ULN. Normal range is 24-207 U/L.
White blood cells: <=3.0 or >20 10^9/L
Hemoglobin: M<=115, F<=95 g/dL
Hematocrit: M<0.37, F<0.32 L/L
Platelets: <=75 10^9/L
Absolute neutrophil count: <=1.0 10^9/L
Urinalysis: blood, glucose, ketones and total protein: >=2 unit increase from baseline"|Week 4 to Week 16|Safety analysis set with assessments||participants|||Number
684975|NCT01508936|Secondary|Participants With Treatment-Emergent Adverse Events|An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an inability to carry out usual activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 to Week 28|The safety analysis set includes all patients who took at least 1 dose of study drug, regardless of whether the patients were randomized.||participants|||Number
684976|NCT01508936|Secondary|Change From Baseline in Asthma Control Questionnaire (ACQ) at Weeks 4, 8, 12 and 16|The ACQ score was measured using the ACQ-7. Six questions are self-assessments; the seventh item is the result of the patient's % predicted FEV1 measurement. Each item has 7 possible answers on a scale of 0 to 6, and the total score is the mean of all responses (the total scale is therefore 0-6). A score of 0 indicates good asthma control; higher scores indicate increasingly poorer asthma control. Negative change from baseline scores indicate improvement in asthma control.|Baseline (Day 1), Weeks 4, 8, 12 and 16|Full analysis set. Number of participants analyzed represents # with ACQ baseline values. Number participants with assessments in the timeframes are listed with the time designation. ACQ were excluded if obtained at visits which were preceded by usage within 7 days of a limited subset of medications that could significantly alter interpretation.||units on a scale||Standard Error|Least Squares Mean
684977|NCT01508936|Secondary|Change From Baseline in Blood Eosinophil Counts at Weeks 4, 8, 12, 16, Follow-up (Week 28) and Endpoint|Blood eosinophil counts were measured using a standard complete blood count with differential blood test at each scheduled visit. Follow-up was performed approximately 12 weeks after the 16 week treatment period. Endpoint is the last post-baseline assessment.|Baseline (Day 1), Weeks 4, 8, 12, 16, Follow-up (Week 28)|Full analysis set. Number of participants analyzed represents # with blood eosinophil count baseline values. Number participants with assessments in the timeframes are listed with the time designation.||10^9/liter||Standard Deviation|Mean
684978|NCT01508936|Secondary|Change From Baseline in Average Daily Use of Short-Acting Beta-Agonist Therapy (SABA) at Weeks 4, 8, 12, and 16|SABA are used for quick relief of asthma symptoms. The number of times SABA therapy was used was assessed using 3 day recall at scheduled visits. Participants were asked to recall whether SABAs were used within 3 days of the scheduled visit and, if so, how many puffs were used. Daily use was the average of those 3 days. Negative change from baseline scores indicate improvement in asthma control.|Baseline (Day -2 to 1), Weeks 4, 8, 12, and 16|Full analysis set. Number of participants analyzed represents # with SABA use baseline values. Number participants with assessments in the timeframes are listed with the time designation.||puffs of SABA/day||Standard Error|Least Squares Mean
684979|NCT01508936|Secondary|Change From Baseline in the Forced Expiratory Flow at 25% to 75% of the Forced Vital Capacity (FEF25%-75%) at Weeks 4, 8, 12, and 16|The FEF25%-75% is the forced expiratory flow at 25% to 75% of the forced vital capacity. FEF25%-75% was measured using forced expiratory air spirometry. Positive change from baseline scores indicate improvement in asthma control.|Baseline (Day 1), Weeks 4, 8, 12, and 16|Full analysis set. Number of participants analyzed represents # with FEF25%-75% baseline values. Number of participants with assessments in the timeframes are listed with the time designation.||liters/second||Standard Error|Least Squares Mean
684980|NCT01508936|Secondary|Change From Baseline in Forced Vital Capacity (FVC) at Weeks 4, 8, 12, and 16|The FVC is the volume of air that can be forcibly blown out after full inspiration, measured in liters. FV was measured using forced expiratory air spirometry. Positive change from baseline scores indicate improvement in asthma control.|Baseline (Day 1), Weeks 4, 8, 12, and 16|Full analysis set. Number of participants analyzed represents # with FVC baseline values (one reslizumab participant was missing a valid baseline FVC.) Number participants with assessments in the timeframes are listed with the time designation.||liters||Standard Error|Least Squares Mean
684981|NCT01508936|Secondary|Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (% Predicted FEV1) at Weeks 4, 8, 12, 16 and Endpoint|The percent predicted FEV1 is the ratio of the volume of air expired in the first second of a forced expiration to the patient’s predicted FEV based on a similar population without asthma. Percent predicted lung function values were transcribed directly from the lung function report to the CRF, without any calculation by Teva. Positive change from baseline scores indicate improvement in asthma control.|Baseline (Day 1), Weeks 4, 8, 12, and 16|Full analysis set. Number of participants analyzed represents # with FEV1 baseline values (one reslizumab participant was missing a valid baseline FEV1.) Number participants with assessments in the timeframes are listed with the time designation.||percentage of predicted FEV1||Standard Deviation|Mean
684982|NCT01508936|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Weeks 4, 8, 12, and 16|FEV1 is a standard measurement of air movement in the lungs of patients with asthma. It is the volume of air expired in the first second of a forced expiration. Improvement in FEV1 is a measure in the reduction of bronchospasm, the reduction of airway inflammation, or both. FEV1 was measured using forced expiratory air spirometry. Positive change from baseline scores indicate improvement in asthma control.|Baseline (Day 1), Weeks 4, 8, 12, and 16|Full analysis set. Number of participants analyzed represents # with FEV1 baseline values (one reslizumab participant was missing a valid baseline FEV1.) Number participants with assessments in the timeframes are listed with the time designation.||liters||Standard Error|Least Squares Mean
684983|NCT01508936|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 16 in FEV1 Subpopulation|"FEV1 is a standard measurement of air movement in the lungs of patients with asthma. It is the volume of air expired in the first second of a forced expiration. Improvement in FEV1 is a measure in the reduction of bronchospasm, the reduction of airway inflammation, or both. FEV1 was measured using forced expiratory air spirometry.
As with the primary outcome, data represent the slope estimate of change from baseline in FEV1 (measured in liters) at Week 16 versus baseline eosinophil count (measured in 10^9/liter) by treatment group. However the FEV1 subpopulation includes participants with more impaired lung function (% predicted FEV1 <85% at baseline)."|Baseline (Day 1), Week 16|The FEV1 sub-population analysis set includes all participants in the FAS with % predicted FEV1 <85% at baseline. Pulmonary function tests were excluded if a limited subset of medications that could significantly confound interpretation were used within 7 days of scheduled visits.||FEV1 liters/ eosinophils 10^9/liter||Standard Error|Mean
684984|NCT01508936|Secondary|Change From Baseline in Asthma Control Questionnaire (ACQ) Over 16 Weeks Using Mixed Model for Repeated Measures|"The ACQ score was measured using the ACQ-7. Six questions are-self assessments; the seventh item is the result of the patient’s % predicted FEV1 measurement. Each item has 7 possible answers on a scale of 0 to 6, and the total score is the mean of all responses (the total scale is therefore 0-6). A score of 0 indicates good asthma control; higher scores indicate increasingly poorer asthma control. Negative change from baseline scores indicate improvement in asthma control.
During study (Weeks 4, 8, 12 and 16) average value was calculated from mixed model repeated measures (MMRM) with treatment, visit, treatment by visit interaction, history of asthma exacerbation in the previous year, height, baseline value, and sex as fixed factors, and patient as a random effect."|Baseline (Day 1), Weeks 4, 8, 12, 16|Full analysis set of participants who contributed at least once to the analysis. ACQ were excluded from the FAS if they were obtained at scheduled visits which were preceded by usage within 7 days of a limited subset of medications that could significantly confound interpretation.||units on a scale||Standard Error|Least Squares Mean
684985|NCT01508936|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Over 16 Weeks Using Mixed Model for Repeated Measures|"FEV1 is a standard measurement of air movement in the lungs of patients with asthma. It is the volume of air expired in the first second of a forced expiration. Improvement in FEV1 is a measure in the reduction of bronchospasm, the reduction of airway inflammation, or both. FEV1 was measured using forced expiratory air spirometry. Positive change from baseline scores indicate improvement in asthma control.
During study (Weeks 4, 8, 12 and 16) average value was calculated using a mixed effects model for repeated measures (MMRM) with treatment (reslizumab or placebo), blood eosinophil count at baseline, and the interaction of treatment and eosinophil count as a random effect."|Baseline (Day 1), Weeks 4, 8, 12, 16|Full analysis set (FAS) includes randomized patients treated with at least 1 dose of study drug, and contributed at least once to the analysis. Pulmonary function tests were excluded if a limited subset of medications that could significantly confound interpretation were used within 7 days of scheduled visits.||liters||Standard Error|Least Squares Mean
684986|NCT01508936|Primary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 16 in Full Analysis Set|"FEV1 is a standard measurement of air movement in the lungs of patients with asthma. It is the volume of air expired in the first second of a forced expiration. Improvement in FEV1 is a measure in the reduction of bronchospasm, the reduction of airway inflammation, or both. FEV1 was measured using forced expiratory air spirometry.
Data represent the slope estimate of change from baseline in FEV1 (measured in liters) at Week 16 versus baseline eosinophil count (measured in 10^9/liter) by treatment group."|Baseline (Day 1), Week 16|Full analysis set (FAS) includes randomized patients treated with at least 1 dose of study drug, and had assessments in the timeframes. Pulmonary function tests were excluded if a limited subset of medications that could significantly confound interpretation were used within 7 days of scheduled visits.||FEV1 liters/ eosinophils 10^9/liter||Standard Error|Mean
684993|NCT01508832|Primary|The Change in the Average Finger Temperature From Baseline to Post-intervention.||30 minutes prior and 240 minutes post intervention.|The correspondingly-treated(lidocaine, bupivacaine) finger of all 12 study participants included in analysis for each arm/group||degrees centigrade||Standard Error|Mean
684994|NCT01508702|Primary|Number of Subjects With an sUA Level That is < 6.0 mg/dL||6 months|ITT Population||Number of Subjects|Participants||Number
684995|NCT01508676|Secondary|Clinical Neuropathic Pain Features- Constant Pain and Hypersensitivity After Treatment|"Subjects rated their constant pain and hypersensitivity using the Visual Analog Scale after a 2 week phase of using pennsaid lotion and after a 2 week phase of using placebo lotion.
The Visual Analog Scale is subject reported on a scale of 0-10 with 0 being no pain, and 10 being the worst pain they can imagine. Results reported are an average of reported VAS scores for the 28 subjects who completed both phase I and phase II of the study."|2 weeks|||Visual Analog Scale||Standard Deviation|Mean
684996|NCT01508676|Secondary|Clinical Neuropathic Pain Features- Burning After Treatment|"Subjects rated their burning pain using the Visual Analog Scale after a 2 week phase of using pennsaid lotion and after a 2 week phase of using placebo lotion.
The Visual Analog Scale is subject reported on a scale of 0-10 with 0 being no pain, and 10 being the worst pain they can imagine. Results reported are an average of reported VAS scores for the 28 subjects who completed both phase I and phase II of the study."|2 weeks|Only subjects||Visual Analog Scale||Standard Deviation|Mean
684997|NCT01508676|Primary|VAS After Treatment|"Subjects rated their pain using the Visual Analog Scale after a 2 week phase of using pennsaid lotion and after a 2 week phase of using placebo lotion.
The Visual Analog Scale is subject reported on a scale of 0-10 with 0 being no pain, and 10 being the worst pain they can imagine. Results reported are an average of reported VAS scores for the 28 subjects who completed both phase I and phase II of the study."|2 weeks.|Only subjects who completed both phases of the crossover study were considered for data analysis.||Visual Analog Scale||Standard Deviation|Mean
684998|NCT01508455|Secondary|Time to Successful Extubation||From the start of study drug infusion to the study completion/withdrawal (Approximately 48 hours)|Subjects who had successful extubation alone (n=5) were included in this analysis.||Hours||95% Confidence Interval|Median
684999|NCT01508455|Secondary|Time Spent With a Total N-PASS Score >3 During DEX Infusion|The N-PASS score >3 indicates adequately sedated and not manifesting signs of pain/agitation.|Predose, loading dose (LD) 5 & 10mins/if LD is 20mins (5, 10, 15 & 20mins); maintenance infusion: 0 min, every 15mins (1st hr); every 30mins (2hrs), then hourly; within 5mins of DEX discontinuation; 5mins pre and post rescue medication|All subjects who received DEX for at least 6 hours formed the Efficacy Evaluable Population.||Hours||Standard Deviation|Mean
685000|NCT01508455|Secondary|Amount of Rescue Medication for Analgesia During DEX Infusion||During the study drug administration (ie., loading dose 10 or 20 minutes and maintenance infusion minimum of 6 hours up to 24 hours) and during the post drug administration (up to 24 hours).|Number of subject who received rescue medication for analgesia during DEX infusion||mcg/kg|||Number
685001|NCT01508455|Secondary|Amount of Rescue Medication (Midazolam) for Sedation During Dexmedetomidine Infusion||During the study drug administration (ie., loading dose 10 or 20 minutes and maintenance infusion minimum of 6 hours up to 24 hours) and during the post drug administration (up to 24 hours).|No participants analyzed for this assessment since none required rescue Midazolam for sedation.|||||
685002|NCT01508455|Secondary|Incidence of Rescue Medication (Fentanyl or Morphine) Use for Analgesia During DEX Infusion||During the study drug administration (ie., loading dose 10 or 20 minutes and maintenance infusion minimum of 6 hours up to 24 hours) and during the post drug administration (up to 24 hours).|All subjects who received DEX for at least 6 hours formed the Efficacy Evaluable Population.||participant|||Number
685003|NCT01508455|Primary|Percent of Subjects Requiring Rescue Midazolam for Sedation||During the study drug administration (ie., loading dose 10 or 20 minutes and maintenance infusion minimum of 6 hours up to 24 hours) and during the post drug administration (up to 24 hours).|All Subjects who received study drug for at least 6 hours||percentage of participants|||Number
685004|NCT01508325|Secondary|Change From Baseline in Mean Ambulatory 24-hour Heart Rate at Week 12|Pulse rate was measured by palpation on radial artery for 1 minute. Two measurements were made at least 1 to 2 minutes apart. Finally mean heart rate was recorded. The first measured heart rate was used as baseline heart rate. The difference between the last 24 hours heart rate at Week 12 and of the baseline heart rate was calculated.|Baseline and Week 12|ITT analysis population included all randomized subjects. ‘n’ signifies number of subjects evaluable for this outcome measure at given timepoints for each group, respectively.||beats/min||Standard Deviation|Mean
685005|NCT01508325|Secondary|Heart Rate Response Rate|Heart rate response was defined as decrease in heart rate from baseline >=10 percent (%). Heart rate response rate was calculated by using the number of subjects with heart rate response divided by total number of subjects and multiplied by 100.|Week 12|ITT analysis population included all randomized subjects. ‘N’ (number of subjects analyzed) signifies number of evaluable subjects for this outcome measure.||percentage of subjects|||Number
685006|NCT01508325|Secondary|Blood Pressure Response Rate|Blood pressure response was defined as DBP less than or equal to (=<) 90 mmHg or >=10 mmHg decrease in DBP from baseline. Blood pressure response rate was calculated as: number of subjects with blood pressure response divided by total number of subjects and multiplied by 100.|Week 12|ITT analysis population included all randomized subjects. ‘N’ (number of subjects analyzed) signifies number of evaluable subjects for this outcome measure.||percentage of subjects|||Number
685007|NCT01508325|Secondary|Change From Baseline in 24-hour Blood Pressure Variability at Week 12|The ABPM determined blood pressure 3 times hourly in the daytime and once hourly in the nighttime. Only monitoring data with valid data >=80% was used for analysis. Each ABPM lasted for at least 24 hours. The first dynamic blood pressure monitoring was used as baseline. The mean change in the blood pressure variability between the 24-hour blood pressure observed at Week 12 and baseline was calculated.|Baseline and Week 12|ITT analysis population included all randomized subjects. ‘n’ signifies number of subjects evaluable for this outcome measure at given timepoints for each group, respectively.||mmHg||Standard Deviation|Mean
685008|NCT01508325|Secondary|Change From Baseline in Mean Ambulatory Night-time Heart Rate at Week 12|Pulse rate was measured by palpation on radial artery for 1 minute. Two measurements were made at least 1 to 2 minutes apart. Finally mean heart rate was recorded. The first measured heart rate was used as baseline heart rate. The difference between the nighttime heart rate at Week 12 treatment and of the baseline heart rate was calculated to measure the change of mean ambulatory nighttime heart rate at the end of the treatment. Nighttime was defined as 10:00 pm to 06:00 am.|Baseline and Week 12|ITT analysis population included all randomized subjects. ‘n’ signifies number of subjects evaluable for this outcome measure at given timepoints for each group, respectively.||beats/min||Standard Deviation|Mean
685009|NCT01508325|Secondary|Change From Baseline in Mean Ambulatory Daytime Heart Rate at Week 12|Pulse rate was measured by palpation on radial artery for 1 minute. Two measurements were made at least 1 to 2 minutes apart. Finally mean heart rate was recorded. The first measured daytime heart rate was used as baseline heart rate. The difference between the daytime heart rate at Week 12 treatment and of the baseline heart rate was calculated to measure the change of mean ambulatory daytime heart rate at the end of the treatment. Daytime in this study was defined as 06:00 am to 10:00 pm.|Baseline and Week 12|ITT analysis population included all randomized subjects. ‘n’ signifies number of subjects evaluable for this outcome measure at given timepoints for each group, respectively.||beats/min||Standard Deviation|Mean
685010|NCT01508325|Secondary|Change From Baseline in Mean Ambulatory Night-time Blood Pressure at Week 12|The ABPM determined blood pressure once hourly in the nighttime. Only monitoring data with valid data >=80% was used for analysis. Each ABPM lasted for at least 24 hours. The first nighttime blood pressure monitoring was used as baseline. The difference between the mean ambulatory nighttime blood pressure observed at Week 12 and baseline was calculated to find out the change of mean ambulatory nighttime blood pressure at the end of the treatment. Nighttime in this study was defined as 10:00 pm to 06:00 am.|Baseline and Week 12|ITT analysis population included all randomized subjects. ‘n’ signifies number of subjects evaluable for this outcome measure at given timepoints for each group, respectively.||mmHg||Standard Deviation|Mean
685011|NCT01508325|Secondary|Change From Baseline in Mean Ambulatory Daytime Blood Pressure at Week 12|The ABPM determined blood pressure 3 times hourly in the daytime. Only monitoring data with valid data >=80% was used for analysis. Each ABPM lasted for at least 24 hours. The first dynamic daytime blood pressure monitoring was used as baseline. The difference between the mean ambulatory daytime blood pressure observed at Week 12 and baseline was calculated to find out the change of mean ambulatory daytime blood pressure at the end of the treatment. Daytime in this study was defined as time between 06:00 am to 10:00 pm.|Baseline and Week 12|ITT analysis population included all randomized subjects. ‘n’ signifies number of subjects evaluable for this outcome measure at given timepoints for each group, respectively.||mmHg||Standard Deviation|Mean
685012|NCT01508325|Secondary|Change From Baseline in Mean Ambulatory 24-hour Blood Pressure at Week 12|The ABPM determined blood pressure 3 times hourly in the daytime and once hourly in the nighttime. Only monitoring data with valid data >=80% was used for analysis. Each ABPM lasted for at least 24 hours. The first dynamic blood pressure monitoring was used as baseline. The difference between the mean ABPM observed in the last 24 hours at Week 12 and baseline was calculated to find out the change of mean ABPM at the end of the treatment.|Baseline and Week 12|ITT analysis population included all randomized subjects. ‘n’ signifies number of subjects evaluable for this outcome measure at given timepoints for each group, respectively.||mmHg||Standard Deviation|Mean
685013|NCT01508325|Secondary|Change From Baseline in Mean Ambulatory Systolic Blood Pressure (SBP) in the Last 4 Hours After 12-week Treatment|The ABPM determined blood pressure 3 times hourly in the daytime and once hourly in the nighttime. Only monitoring data with valid data >=80% was used for analysis. Each ABPM lasted for at least 24 hours. The first dynamic blood pressure monitoring was used as baseline. The difference between the mean ambulatory SBP observed in the last 4 hours after 12-week treatment and baseline was calculated to find out the change of mean ambulatory SBP at the end of the treatment.|Baseline and Week 12|ITT analysis population included all randomized subjects. ‘n’ signifies number of subjects evaluable for this outcome measure at given timepoints for each group, respectively.||mmHg||Standard Deviation|Mean
685110|NCT01507246|Primary|Total Opioid Burden|Total opioid consumed (IV and PO) postsurgically until the hospital discharge order is written or through Day 30, whichever is sooner.|Wound closure to time hospital discharge order written or Day 30, whichever is sooner|Per protocol||mg||Standard Deviation|Mean
685014|NCT01508325|Primary|Change From Baseline in Mean Heart Rate in the Last 4 Hours After 12-week Treatment|Pulse rate was measured by palpation on radial artery for 1 minute. Two measurements were made at least 1 to 2 minutes apart. Finally mean heart rate was recorded. The first measured heart rate was used as baseline heart rate. The difference between the last 4 hours heart rate after 12-week treatment and of the baseline heart rate was calculated to measure the change in mean heart rate at the end of the treatment.|Baseline and Week 12|ITT analysis population included all randomized subjects. ‘n’ signifies number of subjects evaluable for this outcome measure at given timepoints for each group, respectively.||beats/min||Standard Deviation|Mean
685015|NCT01508325|Primary|Change From Baseline in Mean Ambulatory Diastolic Blood Pressure (DBP) in the Last 4 Hours After 12-week Treatment|Ambulatory blood pressure monitoring (ABPM) determined blood pressure 3 times hourly in the daytime and once hourly in the nighttime. Only monitoring data with valid data greater than or equal to (>=) 80 percent (%) was used for analysis. Each ABPM lasted for at least 24 hours. The first dynamic blood pressure monitoring was used as baseline. The difference between the mean ambulatory DBP observed in the last 4 hours after 12-week treatment and baseline was calculated to find out the change of mean ambulatory DBP at the end of the treatment.|Baseline and Week 12|ITT analysis population included all the randomized subjects. ‘n’ signifies number of subjects evaluable for this outcome measure at given timepoints for each group, respectively||mmHg||Standard Deviation|Mean
685016|NCT01508169|Secondary|Manchester Foot and Pain Disability Index(MFPDI)|"The MFPDI is a test used to assess disability related to foot pain in elderly. It consists of 19 statements prefaced by the phrase Because of pain in my feet…, organized under three constructs: functional limitation (10 items), pain intensity (five items), and personal appearance (two items). For each statement, there are three possible answers: none of the time (score = 0), some days (score = 1), and most days/every day (score = 2). The final score is the sum of all the items and ranges from 0 to 38. The higher score, the greater disability."|4 weeks|A pilot study (with 14 subjects wearing insoles and 15 controls) was conducted.To identify differences between groups for the variables (Berg, TUG, pain, disability) with a 80% power and a significance level of 5 % the number of 45 subjects in each group was considered satisfactory.||scores on a scale||Standard Deviation|Mean
685017|NCT01508169|Secondary|Numeric Pain Scale|Subjects were asked to rate the pain in their feet on a scale from 0 to 10 (0: no pain, 10: extremely severe pain)|4 weeks|A pilot study (with 14 subjects wearing insoles and 15 controls) was conducted.To identify differences between groups for the variables (Berg, TUG, pain, disability) with a 80% power and a significance level of 5 % the number of 45 subjects in each group was considered satisfactory.||units on a scale||Standard Deviation|Mean
685018|NCT01508169|Primary|Timed up and Go Test (TUG)|The TUG test is used to assess the dynamic balance of an individual. It measures the amount of time (recorded in seconds) it takes for the individual to rise from a standard arm chair, walk a distance of 3 meters and return to the initial position resting against the back of the chair.|4 weeks|A pilot study (with 14 subjects wearing insoles and 15 controls) was conducted.To identify differences between groups for the variables (Berg, TUG, pain, disability) with a 80% power and a significance level of 5 % the number of 45 subjects in each group was considered satisfactory.||seconds||Standard Deviation|Mean
685019|NCT01508169|Primary|Berg Balance Scale (BBS)|The BBS is a balance assessment test that rates the ability of a subject to maintain balance while performing each of 14 movements required in everyday activities (transferring, standing unsupported, rising from a sitting to a standing position, tandem standing, turning 360° and single-leg standing). Scoring is based on an ordinal 5-point scale from 0 to 4. Total scores ranges from 0 to 56. The smaller value, the worse balance: from 0-20: a whell chair is needed: 20-41: needing walk assistence; 41-56 - independent walking.|4 weeks|A pilot study (with 14 subjects wearing insoles and 15 controls) was conducted.To identify differences between groups for the variables (Berg, TUG, pain, disability) with a 80% power and a significance level of 5 % the number of 45 subjects in each group was considered satisfactory.||scores on a scale||Standard Deviation|Mean
685020|NCT01508130|Secondary|Change From Baseline in Work Loss And Productivity Outcomes (WPAI)|WPAI-AS is a 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to ankylosing spondylitis for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). Each sub-scores was scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity.|Baseline (Day 1 ), Weeks 2, 4, 6, 8, 12, 16, 24, 36, 48, 12 weeks post-treatment|Safety population: It included all enrolled participants who received at least one dose of study treatment (triple therapy) and had at least one post-baseline safety assessment. “n” denotes number of participants who were available at the indicated time points for each arm.||units on a scale||Standard Error|Least Squares Mean
685021|NCT01508130|Secondary|Number of Participants With Any AEs and Serious Adverse Events (SAEs)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.|Up to 12 weeks post-treatment|Safety population: It included all enrolled participants who received at least one dose of study treatment (triple therapy) and had at least one post-baseline safety assessment. All 671 participants received at least one dose of study drug; however, 632 of these participants were included in the safety population.||participants|||Number
685022|NCT01508130|Secondary|Number of Participants With Premature Treatment Discontinuation Due to Adverse Events (AEs)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.|Up to 48 weeks|Safety population: It included all enrolled participants who received at least one dose of study treatment (triple therapy) and had at least one post-baseline safety assessment.||participants|||Number
685319|NCT01504971|Primary|Diagnostic Ability of Each Endoscopic Finding for GERD Symptom.|Patients with GERD symptom receive endoscopic tri-modal imaging within 1 month|1 month|||percentage of participants||95% Confidence Interval|Number
685023|NCT01508130|Secondary|Number of Participants With Safety-related Dose Reductions|The dose reduction was done because of safety-related reasons (AEs) including alanine aminotransferase disorder, anemia, neutropenia, thrombocytopenia, and rash.|Up to 48 weeks|Safety population: It included all enrolled participants who received at least one dose of study treatment (triple therapy) and had at least one post-baseline safety assessment.||participants|||Number
685024|NCT01508130|Secondary|Number of Participants Treated With PegIFN, RBV, and BOC as Per the U.S. Label|As per the U.S. labeling, participants with cirrhosis (C); non-cirrhotic/treatment-naïve (NC/TN); and non-cirrhotic/previous partial responders or relapsers (NC/PPR or R) received first 4 weeks of dual therapy, followed by additional 28 or 36 weeks of PegIFN + RBV + BOC (triple therapy) and/or then completed dual therapy through Week 48 depending on viral response and prior response status.|Up to 48 weeks (included 4 weeks of dual therapy + additional 28/36 weeks of triple therapy and/or additional dual therapy up to Week 48)|The safety population was defined as all enrolled participants who received at least one dose of study treatment (triple therapy) and had at least one post-baseline safety assessment. “n” denotes number of participants who were available at the indicated time points for each arm.||participants|||Number
685025|NCT01508130|Secondary|Number of Participants Treated With PegIFN, RBV, and TEL as Per the U.S. Label|As per the U.S. labeling, participants with treatment-naive, prior relapse (TN-PR) and prior partial or null responder (PP/NR) received PegIFN + RBV + TEL (triple therapy) for 12 weeks; followed additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.|Up to 48 weeks (included 12 weeks of triple therapy + additional 12/36 weeks of dual therapy)|Safety population: It included all enrolled participants who received at least one dose of study treatment (triple therapy) and had at least one post-baseline safety assessment. “n” denotes number of participants who were available at the indicated time points for each arm.||participants|||Number
685026|NCT01508130|Secondary|Compliance of Study Treatment|Compliance was assessed based on the number of participants who received the planned study treatment (PegIFN alfa-2a, PegIFN alfa-2b, ribavirin, telaprevir, and boceprevir) during the treatment period.|Weeks 4, 8, 12, and 24|Safety population: It included all enrolled participants who received at least one dose of study treatment (triple therapy) and had at least one post-baseline safety assessment. “n” denotes number of participants who were available at the indicated time points for each arm.||participants|||Number
685027|NCT01508130|Secondary|Percentage of Dose Reduction, as Measure of Extent of Exposure to Study Medication|Extent of exposure is defined as the duration of the treatment administered during the study. Degree of dose reduction was calculated as actual exposure/target exposure × 100%. Target exposure was defined as the actual received treatment duration multiplied by the initial assigned dose. Actual exposure was defined as cumulative dose during the treatment period.|From the date of the first dose of the study drug up to withdrawal/study completion (up to Study Week 48)|Safety population: It included all enrolled participants who received at least one dose of study treatment (triple therapy) and had at least one post-baseline safety assessment. “n” denotes number of participants who were available at the indicated time points for each arm.||Percentage of dose reduction||Standard Deviation|Mean
685028|NCT01508130|Secondary|Mean Cumulative Dose, as Measure of Extent of Exposure to Study Medication|Extent of exposure is defined as the duration of the treatment administered during the study. The mean cumulative doses of PegIFN alfa-2a, PegIFN alfa-2b, ribavirin, telaprevir, and boceprevir were presented.|From the date of the first dose of the study drug up to withdrawal/study completion (up to Study Week 48)|Safety population: It included all enrolled participants who received at least one dose of study treatment (triple therapy) and had at least one post-baseline safety assessment. “n” denotes number of participants who were available at the indicated time points for each arm.||Micrograms||Standard Deviation|Mean
685029|NCT01508130|Secondary|Treatment Duration, as Measure of Extent of Exposure to Study Medication|Extent of exposure is defined as the duration of the treatment administered during the study. The mean duration of exposure to PegIFN alfa-2a, PegIFN alfa-2b, ribavirin, telaprevir, and boceprevir is calculated as the number of weeks between the start and end of treatment.|From the date of the first dose of the study drug up to withdrawal/study completion (up to Study Week 48)|Safety population: It included all enrolled participants who received at least one dose of study treatment (triple therapy) and had at least one post-baseline safety assessment. “n” denotes number of participants who were available at the indicated time points for each arm.||Weeks||Standard Error|Mean
685030|NCT01508130|Secondary|Time to Premature Treatment Discontinuation Due to Intolerance|The participants discontinued the study treatment due to intolerance of the study treatment. Time to premature treatment discontinuation due to intolerance (weeks) = (date of treatment discontinuation due to lack of intolerance - first treatment administration date + 1)/7. Participants who were ongoing or completed the study treatment (including those who shortened the treatment based on response-guided therapy) were censored at the date of their last dosing.|Up to Week 48|mTRT population: It included all enrolled participants with HCV RNA of 50 IU/mL or more just prior to start CHC therapy, received 1 triple therapy, and treatment documentation was sufficient for assignment to treatment groups.||Weeks||Full Range|Median
685031|NCT01508130|Secondary|Time to Premature Treatment Discontinuation Due to Lack of Efficacy|The participants discontinued the study treatment due to lack of efficacy of study treatment. Time to premature treatment discontinuation due to lack of efficacy (weeks) = (date of treatment discontinuation due to lack of efficacy - first treatment administration date + 1)/7. Participants who were ongoing or completed the study treatment (including those who shortened the treatment based on response-guided therapy) were censored at the date of their last dosing.|Up to Week 48|mTRT population: It included all enrolled participants with HCV RNA of 50 IU/mL or more just prior to start CHC therapy, received 1 triple therapy, and treatment documentation was sufficient for assignment to treatment groups.||Weeks||Full Range|Median
685032|NCT01508130|Secondary|Duration of Viral Undetectability During Treatment for Participants With HCV RNA Undetectable During Treatment by Trial Treatment|The undetectable HCV RNA means HCV RNA values less than 50 IU/mL. This outcome measure was calculated as the duration of participant’s first date of undetectable HCV RNA and the date of the participant’s last dose.|Up to Week 48|mTRT population: It included all enrolled participants with HCV RNA of 50 IU/mL or more just prior to start CHC therapy, received 1 triple therapy, and treatment documentation was sufficient for assignment to treatment groups.||weeks||Full Range|Median
685033|NCT01508130|Secondary|Number of Participants With SVR by Subgroups (Demographic and Baseline Factors)|Participants for VR to prior therapy (PegIFN + RBV) were categorized as: relapse (who completed the previous treatment with HCV RNA undetectable, but relapsed with detectable HCV RNA once treatment was discontinued), breakthrough (HCV RNA undetectable, followed by detectable HCV RNA during on-treatment period), null responder (completed at least 12 weeks of treatment with HCV RNA decrease < 2 log10 at Week 12), partial responder (HCV RNA decrease > 2 log10 by Week 12 of treatment and HCV RNA remained detectable), unknown response (completed previous treatment, but treatment response based on HCV RNA determinations was not available), and prior intolerant (treated previously, but discontinued due to adverse event or participant’s choice prior to completion of therapy). Participants categorized into 3 genotypes (CC, CT and TT) based on single nucleotide polymorphism in the Interleukin 28B (IL28B) gene.|Week 12|mTRT population: It included all enrolled participants with HCV RNA of 50 IU/mL or more just prior to start CHC therapy, received 1 triple therapy, and treatment documentation was sufficient for assignment to treatment groups. “n” denotes number of participants who were available at the indicated time points for each arm.||participants|||Number
685034|NCT01508130|Secondary|Predictors of Sustained Virologic Response by Week|SVR rate defined as the number of participants with undetectable HCV RNA (i.e., HCV RNA less than 50 IU/mL) at 12 weeks or later post-completion of the treatment period. The predictors defined as participants with virological response (HCV RNA < 50 IU/mL at any visit), or with virological response at Week 12 (HCV-RNA < 50 IU/mL or unquantifiable or HCV-RNA >=2 log10 drop from baseline). Positive predictive value is the probability that participants with a positive screening test truly have the disease. Negative predictive value is the probability that participants with a negative screening test truly don't have the disease.|Weeks 2, 4, 6, 8, and 12|mTRT population: It included all enrolled participants with HCV RNA of 50 IU/mL or more just prior to start CHC therapy, received 1 triple therapy, and treatment documentation was sufficient for assignment to treatment groups. “n” denotes number of participants who were available at the indicated time points for each arm.||participants|||Number
685035|NCT01508130|Secondary|Number of Participants Who Achieved Extended VR, Virologic Breakthrough/Rebound, Virologic Relapse, and Who Were Non-responder|The extended VR is defined as initial HCV RNA < 50 IU/mL during Weeks 2 to 24 and remaining HCV RNA < 50 IU/mL at all subsequent assessments; virologic breakthrough/rebound is defined as detectable HCV RNA during the treatment period in participants with prior non-detectable HCV RNA or increase of HCV RNA by >=1 log10 above nadir for direct-acting antiviral (DAA) tripe therapies (PegIFN + RBV + TEL or PegIFN + RBV + BOC); virologic relapse is defined as detectable HCV RNA during the treatment-free follow-up period in participants with HCV RNA < 50 IU/mL at EoT; non-responder is defined as participants who never achieved undetectable HCV-RNA during the 48 weeks of treatment.|Up to Week 48|mTRT population: It included all enrolled participants with HCV RNA of 50 IU/mL or more just prior to start CHC therapy, received 1 triple therapy, and treatment documentation was sufficient for assignment to treatment groups. “n” denotes number of participants who were available at the indicated time points for each arm.||participants|||Number
685036|NCT01508130|Secondary|Number of Participants With VR by Categories of Very Rapid VR (VRVR), Rapid Virological Response (RVR), VR Week 8, Early Virological Response (cEVR), Partial Virological Response (pEVR), and None of the Above|VRVR was defined as HCV RNA < 50 IU/mL at treatment Week 2; RVR as HCV RNA < 50 IU/mL by treatment Week 4, but no HCV RNA < 50 IU/mL at Week 2; Week 8 VR as HCV RNA < 50 IU/mL by study Week 8 but no HCV RNA < 50 IU/mL at Weeks 2 to 4; cEVR as HCV RNA < 50 IU/mL by treatment Week 12 but no HCV RNA < 50 IU/mL at Weeks 2 to 8; and pEVR as at least a 2 log10 decrease in HCV RNA by treatment Week 12 but no HCV RNA < 50 IU/mL at Weeks 2 to 12.|Weeks 2, 4, 8, and 12|mTRT population: It included all enrolled participants with HCV RNA of 50 IU/mL or more just prior to start CHC therapy, received 1 triple therapy, and treatment documentation was sufficient for assignment to treatment groups. “n” denotes number of participants who were available at the indicated time points for each arm.||participants|||Number
685037|NCT01508130|Secondary|Number of Participants With Virologic Response (VR)|VR was defined as undetectable HCV RNA (i.e.,HCV RNA less than 50 IU/mL)|Weeks 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48; and 12 weeks post-completion of treatment period|mTRT population: It included all enrolled participants with HCV RNA of 50 IU/mL or more just prior to start CHC therapy, received 1 triple therapy, and treatment documentation was sufficient for assignment to treatment groups. “n” denotes number of participants who were available at the indicated time points for each arm.||participants|||Number
685038|NCT01508130|Primary|Number of Participants With Sustained Virologic Response (SVR) at 12 Weeks or Later After Completion of the Treatment Period|SVR rate defined as the number of participants with undetectable HCV RNA (i.e., HCV RNA less than 50 IU/mL) at 12 weeks or later post-completion of the treatment period|12 weeks or later post-completion of the treatment period|mTRT population: It included all enrolled participants with HCV RNA of 50 IU/mL or more just prior to start CHC therapy, received 1 triple therapy, and treatment documentation was sufficient for assignment to treatment groups.||participants|||Number
685039|NCT01508130|Primary|Time to Premature Treatment Discontinuation Due to Any Reason|Time to premature treatment discontinuation for any reason (weeks) was calculated as follows: date of treatment discontinuation for any reason – first treatment administration date + 1/7. The estimated survivorship curves were obtained from Kaplan-Meier maximum likelihood estimates for each treatment group. Participants who completed the study treatment (including those who shorten the treatment based on response-guided therapy) were censored on their last dosing date.|Up to the treatment discontinuation or the date of the last dosing for participants who were ongoing or completed the study treatment (including those who shorten the treatment based on response-guided therapy)|modified all-treated (mTRT) population: It included all enrolled participants who had an hepatitis C Virus Ribo Nucleic Acid (HCV RNA) of 50 IU/mL or more just prior to start chronic hepatitis C (CHC) therapy, received 1 triple therapy (PegIFN, RBV, and TEL or BOC), and treatment documentation was sufficient for assignment to treatment groups.||weeks||95% Confidence Interval|Median
685040|NCT01508117|Primary|Overall Survival||average 1 year|||years|||Number
685041|NCT01508052|Primary|Core Body Temperature|Core temperature and arteriovenous shunt in the lower leg was measured using oesophageal temperature and the calf-minus-toe skin-surface temperature gradient.|from baseline record core temperature every 15 minutes up to operative end|||degree C||Standard Deviation|Mean
685042|NCT01508013|Primary|Indoor Tanning Willingness|Scale that measures adolescents willingness to indoor tan in the future. Indoor tanning willingness is measured on a scale that ranges from 1 (definitely not willing; better) to 7 (definitely willing; worse).|12 months|Adolescent females aged 12-18 years old that expressed interest in indoor tanning in the future.||units on a scale||Standard Deviation|Mean
685043|NCT01508013|Primary|Indoor Tanning Intentions|A validated measure of the teenagers intentions to use indoor tanning in the next 12 months. Indoor tanning intentions are measured on a scale that ranges from 1 (definitely do not intend to indoor tan; better) to 7 (definitely do intend to indoor tan; worse).|12 months|Adolescent females aged 12-18 years old who expressed interest in indoor tanning in the next year.||units on a scale||Standard Deviation|Mean
685044|NCT01508013|Primary|Indoor Tanning Behavior|Self-report measure of the number of times the teenager has indoor tanned over 12 month time period. The self-report measure has been validated in previous studies.|12 months|Adolescent females aged 12-18 years old who expressed interest in indoor tanning in the future.||Indoor tanning sessions over past year||Standard Deviation|Mean
685075|NCT01507831|Secondary|Percent Change From Baseline in Apo A1 at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Apo A1 ITT population.||percent change||Standard Error|Least Squares Mean
685076|NCT01507831|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|ITT population.||percent change||Standard Error|Mean
685069|NCT01507831|Post-Hoc|Percentage of Participants Who Experienced Major Adverse CV Events|Major adverse CV events were defined as all adverse CV events except Congestive heart failure (CHF) requiring hospitalization; and ischemia-driven coronary revascularization procedure.|Up to 10 weeks after last study drug administration (maximum of 86 weeks)|Safety population.||percentage of participants|||Number
685070|NCT01507831|Other Pre-specified|Percentage of Participants Who Experienced Cardiovascular (CV) Events|CV events included coronary heart disease (CHD) death; non-fatal myocardial infarction (MI); fatal and non-fatal ischemic stroke; unstable angina requiring hospitalization; congestive heart failure (CHF) requiring hospitalization; ischemia-driven coronary revascularization procedure. Reported events are CV events as confirmed by an independent Clinical Events Committee (CEC) that occurred during the treatment emergent period ( i.e. from first dose up to the last dose of study drug + 70 days).|Up to 10 weeks after last study drug administration (maximum of 86 weeks)|Safety population.||percentage of participants|||Number
685071|NCT01507831|Other Pre-specified|Percent Change From Baseline in Calculated LDL-C at Week 78 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 78 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 78 (i.e. up to 21 days after last injection).|From Baseline to Week 78|mITT population.||percent change||Standard Error|Least Squares Mean
685072|NCT01507831|Other Pre-specified|Percent Change From Baseline in Calculated LDL-C at Week 78 - ITT Analysis|Adjusted LS means and standard errors at Week 78 from MMRM model including all available post-baseline data from Week 4 to Week 78 regardless of status on- or off-treatment.|From Baseline to Week 78|ITT population.||percent change||Standard Error|Least Squares Mean
685073|NCT01507831|Other Pre-specified|Percent Change From Baseline in Calculated LDL-C at Week 52 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 52 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|From Baseline to Week 52|mITT population.||percent change||Standard Error|Least Squares Mean
685074|NCT01507831|Other Pre-specified|Percent Change From Baseline in Calculated LDL-C at Week 52 - ITT Analysis|Adjusted LS means and standard errors at Week 52 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.||percent change||Standard Error|Least Squares Mean
685078|NCT01507831|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|ITT population.||percent change||Standard Error|Mean
685079|NCT01507831|Secondary|Percent Change From Baseline in Apo A1 at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline Apo A1 value on- or off-treatment (Apo A1 ITT population).||percent change||Standard Error|Least Squares Mean
685080|NCT01507831|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|ITT population.||percent change||Standard Error|Mean
685081|NCT01507831|Secondary|Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline HDL-C value on- or off-treatment (HDL-C ITT population).||percent change||Standard Error|Least Squares Mean
685082|NCT01507831|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 were obtained from multiple imputation approach followed by robust regression model for handling of missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment were included in the imputation model.|From Baseline to Week 52|ITT population.||percent change||Standard Error|Mean
685083|NCT01507831|Secondary|Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis|Adjusted percentages at Week 24 from multiple imputation approach model including available post-baseline data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|Up to Week 52|mITT population.||percentage of participants|||Number
685084|NCT01507831|Secondary|Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis|Adjusted percentages at Week 24 were obtained from multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were included in the imputation model.|Up to Week 52|ITT population.||percentage of participants|||Number
685085|NCT01507831|Secondary|Percentage of Very High CV Risk Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - On-Treatment Analysis|Adjusted percentages at Week 24 were from multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|Up to Week 52|mITT population.||percentage of participants|||Number
685086|NCT01507831|Secondary|Percentage of Very High Cardiovascular (CV) Risk Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - ITT Analysis|Very high CV risk: Heterozygous Familial Hypercholesterolemia (heFH) participants with coronary heart disease (CHD) or CHD risk equivalents or non- Familial Hypercholesterolemia (FH). High CV risk: heFH participants without CHD or CHD risk equivalents. CHD risk equivalent: peripheral arterial disease, ischemic stroke, moderate chronic kidney disease (estimated glomerular filtration rate, 30 to <60 ml/minute/1.73 m^2 of body-surface area), or diabetes mellitus plus 2 or more additional risk factors (hypertension; ankle-brachial index of ≤0.90; microalbuminuria, macroalbuminuria, or a urinary dipstick result of >2+ protein; preproliferative or proliferative retinopathy or laser treatment for retinopathy; or family history of premature CHD). Adjusted percentages at Week 24 were obtained from multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were included in imputation model.|Up to Week 52|ITT population.||percentage of participants|||Number
685087|NCT01507831|Secondary|Percent Change From Baseline in Total-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Total-C ITT population.||percent change||Standard Error|Least Squares Mean
685088|NCT01507831|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Non-HDL-C ITT population.||percent change||Standard Error|Least Squares Mean
685089|NCT01507831|Secondary|Percent Change From Baseline in Apo B at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Apo B ITT population.||percent change||Standard Error|Least Squares Mean
685090|NCT01507831|Secondary|Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline Total-C value on- or off-treatment (Total-C ITT population).||percent change||Standard Error|Least Squares Mean
685091|NCT01507831|Secondary|Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|From Baseline to Week 52|Participants of the mITT population with one baseline and at least one post-baseline non-HDL-C value on-treatment (non-HDL-C mITT population).||percent change||Standard Error|Least Squares Mean
685092|NCT01507831|Secondary|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment (non-HDL-C ITT population).||percent change||Standard Error|Least Squares Mean
685093|NCT01507831|Secondary|Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|From Baseline to Week 52|Participants of the mITT population with one baseline and at least one post-baseline Apo-B value on-treatment (Apo B mITT population).||percent change||Standard Error|Least Squares Mean
685094|NCT01507831|Secondary|Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline Apo B value on- or off-treatment (Apo B ITT population).||percent change||Standard Error|Least Squares Mean
685095|NCT01507831|Secondary|Percent Change From Baseline in Measured LDL-C at Week 24 - ITT Analysis|Measured LDL-C values via beta quantification method. Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline measured LDL-C value on- or off-treatment.||percent change||Standard Error|Least Squares Mean
685096|NCT01507831|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - On-treatment Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|From Baseline to Week 52|mITT population.||percent change||Standard Error|Least Squares Mean
685097|NCT01507831|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.||percent change||Standard Error|Least Squares Mean
685098|NCT01507831|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection) (on-treatment analysis).|From Baseline to Week 52|Modified ITT (mITT) population: all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.||percent change||Standard Error|Least Squares Mean
685099|NCT01507831|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis|Adjusted least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on­ or off-treatment were used in the model (ITT analysis).|From Baseline to Week 52|ITT population: all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on­ or off-treatment.||percent change||Standard Error|Least Squares Mean
685100|NCT01507831|Primary|Percentage of Participants Who Experienced Adverse Events (AEs)|Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the ‘treatment-emergent period’ (the time from the first dose of study drug up to the last dose of study drug +70 days).|Up to 10 weeks after last study drug administration (maximum of 86 weeks)|Safety population: all randomized participants who received at least one dose or part of a dose of a study drug (treated).||percentage of participants|||Number
685101|NCT01507662|Primary|Guideline Concordant Osteoporosis Therapy|Guideline concordant was defined as those who prescribed a National Osteoporosis Foundation approved osteoporosis therapy for patients with osteoporosis (T-score of femoral neck, hip, or spine ≤−2.5 or FRAX ≥20 %), or patients with a self-reported history of low impact fracture, or patients with osteopenia (T-score between −1.0 and −2.5 at the femoral neck, hips, or lumbar spine) and a 10-year probability of a major osteoporosis-related fracture ≥20 % OR those who were not prescribed a therapy for patients with no self-reported history of prior DXA and study DXA shows normal BMD and no self-reported history of low impact fracture, or study DXA shows osteopenia (T-score of femoral neck, hip, or spine between −1 and −2.5) and FRAX <20 %) and no self-reported history of low impact fracture, or self-reported prior DXA but no self-reported history of low impact fracture and no self-reported history of osteoporosis.|12 weeks after DXA|||Participants|||Count of Participants
685102|NCT01507493|Secondary|Preoperative Pressure Pain Tolerance (PTO)|The probe of pressure algometer was positioned perpendicularly to the skin surface of the patient, and the investigator applied continuous pressure at approximately the same rate according to the visual LCD display on the algometer. subjects were asked to say “ok” when they started to feel the pain became intolerable during the stimulation. The value from the LCD was recorded as the pressure pain tolerance.|12 hours before the operation|||kg/cm2||Standard Deviation|Mean
685103|NCT01507493|Primary|PCA Press Frequency 48h After Operation.||48 hours after the operation|||presses per day||Standard Deviation|Mean
685104|NCT01507493|Secondary|Preoperative Pressure Pain Threshold (PPT)|The probe of pressure algometer was positioned perpendicularly to the skin surface of the patient, and the investigator applied continuous pressure at approximately the same rate according to the visual LCD display on the algometer. subjects were asked to say “pain” when they started to feel pain during the stimulation. The value from the LCD was recorded as the pressure pain threshold.|12 hours before the operation|||kg/cm2||Standard Deviation|Mean
685105|NCT01507493|Secondary|The Visual Analog Scale 48h After Operation.|The visual analog scale (VAS) is used for pain evaluation at rest during patient-controlled analgesia (PCA) treatment 48h after operation. And the visual analog scale is from 0 to 10 which 0 represent no pain while 10 represent unbearable pain|48 hours after the operation|||units on a scale||Standard Deviation|Mean
685106|NCT01507493|Primary|Opioid Consumption Dose 48h After Operation.||48 hours after the operation|||microgramme||Standard Deviation|Mean
685107|NCT01507246|Primary|Health Economic Benefits - Length of Stay|Length of stay (LOS), recorded in hours and converted to days with one decimal of precision, defined as the time of completion of the wound closure until the hospital discharge order is written or through Day 30, whichever is sooner.|Up to Day 30|All subjects analyzed, no censored events||days||Inter-Quartile Range|Median
685108|NCT01507246|Secondary|Incidence of Predefined Opioid-related Adverse Events|The incidence of predefined opioid-related adverse events|From the time the informed consent is signed to the time hospital discharge order is written or through Day 30 (after surgery), which ever is sooner|Per protocol.||Number of patients|||Number
685111|NCT01507233|Secondary|Incidence of Opioid-related Adverse Events and Patient Satisfaction With Postsurgical Analgesia.|"Incidence of opioid-related adverse events defined as somnolence, respiratory depression, hypoventilation, hypoxia, dry mouth, nausea, vomiting, constipation, sedation, confusion, pruritus, urinary retention, and postoperative ileus.
Responses to one question pertaining to patient satisfaction with postsurgical analgesia and four questions pertaining to postsurgical recovery following hospital discharge."|Wound closure to time hospital discharge order written or Day 30, whichever is sooner.|As no subjects received EXPAREL in this study, statistical analyses were not performed.|||||
685112|NCT01507233|Primary|Health Economic Benefits|"Total cost of hospitalization until the time hospital discharge order is written or through Day 30, whichever is sooner.
Length of stay (LOS), recorded in hours, defined as the time of completion of the wound closure until the hospital discharge order is written or through Day 30, whichever is sooner."|Wound closure to Day 30|As no subjects received EXPAREL in this study, statistical analyses were not performed.|||||
685113|NCT01507233|Primary|Total Opioid Burden|Total opioid consumed (IV and PO) postsurgically until the hospital discharge order is written or through Day 30, whichever is sooner.|Wound closure to time hospital discharge order written or Day 30, whichever is sooner|As no subjects received EXPAREL in this study, statistical analyses were not performed.|||||
685114|NCT01507220|Secondary|Patient Satisfaction With Postsurgical Analgesia|Responses to one question pertaining to patient satisfaction with postsurgical pain management and four questions pertaining to postsurgical recovery following hospital discharge.|From the time the informed consent is signed to the time hospital discharge order is written or through Day 30 (after surgery), whichever is sooner|As no subjects received EXPAREL in this study, statistical analyses were not performed.|||||
685115|NCT01507220|Secondary|Incidence of Opioid-related Adverse Events|Incidence of opioid-related adverse events is defined as somnolence, respiratory depression, hypoventilation, hypoxia, dry mouth, nausea, vomiting, constipation, sedation, confusion, pruritus, urinary retention, and postoperative ileus.|From the time the informed consent is signed to the time hospital discharge order is written or through Day 30 (after surgery), whichever is sooner|As no subjects received EXPAREL in this study, statistical analyses were not performed.||Adverse events|||Number
685116|NCT01507220|Primary|Health Economic Benefit|"Total cost of hospitalization to time hospital discharge order is written or through Day 30, whichever is sooner.
Length of stay (LOS), recorded in hours, defined as the time of completion of the wound closure until the hospital discharge order is written or through Day 30, whichever is sooner."|Wound closure to time hospital discharge order written or Day 30, whichever is sooner.|As no subjects received EXPAREL in this study, statistical analyses were not performed.|||||
685117|NCT01507220|Primary|Total Opioid Burden|Total opioid consumed (IV and PO) postsurgically until the hospital discharge order is written or through Day 30, whichever is sooner.|Wound closure to time hospital discharge order written or Day 30, whichever is sooner|As no subjects received EXPAREL in this study, statistical analyses were not performed.|||||
685118|NCT01507181|Secondary|Patient Rated Inventory of Side Effects (PRISE)|The PRISE assesses the presence of treatment side effects in nine organ/function systems (gastrointestinal, nervous system, heart, eyes/ears, skin, genital/urinary, sleep, sexual functioning, and other). Data reported in in Adverse Events section.|duration of study|||events|||Number
685119|NCT01507181|Secondary|The Clinician-Administered Dissociative States Scale (CADSS)|The CADSS measures dissociation with higher scores indicating more severe symptoms (scale range 0 – 92).|baseline, 40 minutes post infusion and 240 minutes post infusion|||units on a scale||Standard Deviation|Mean
685120|NCT01507181|Secondary|The Brief Psychiatric Rating Scale (BPRS)|The BPRS measures psychomimetic effects with higher scores indicating more severe symptoms (scale range 7 – 49).|baseline, 40 minutes post infusion, and 240 minutes post infusion|||units on a scale||Standard Deviation|Mean
685121|NCT01507181|Secondary|The Young Mania Rating Scale (YMRS)|An 11-item questionnaire, used to assess manic symptoms based on the patient's subjective report of his or her clinical condition. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. The scores from each question are added together to form a total score ranging from 0 to 60, with higher scores indicating a greater severity of symptoms.|baseline, 40 minutes post infusion, 240 minutes post infusion|||units on a scale||Standard Deviation|Mean
685122|NCT01507181|Secondary|Suicidality Item of the MADRS (MADRS-SI)|The MADRS-SI ranges from 0 to 6; a score of 2 corresponds to fleeting, passive SI; a score of 4 indicates that SI is frequent with at least moderate intensity but without specific plans or intention; a score of 6 corresponds to active intention and planning for suicide.|24 hours post infusion|||units on a scale||Standard Deviation|Mean
685123|NCT01507181|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS)|The MADRS is a 10-item instrument used for the evaluation of depressive symptoms in adults and for the assessment of any changes to those symptoms. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.|up to 7 days post infusion|||units on a scale||Standard Deviation|Mean
685124|NCT01507181|Primary|Change in Beck Scale for Suicidal Ideation (BSSI)|Change in BSI score at 48 hours following treatment as compared to baseline. Beck Scale is a 21-item self or clinician administered instrumentation used to measure the current intensity of patients' specific attitudes, behaviors and plans to commit suicide. Score range 0-42, with higher score indicating higher intensity.|baseline and 48 hours post infusion|||units on a scale||Standard Deviation|Mean
685125|NCT01507181|Primary|Change in Beck Scale for Suicidal Ideation (BSSI)|Change in BSI score at 24 hours following treatment as compared to baseline. Beck Scale is a 21-item self or clinician administered instrumentation used to measure the current intensity of patients' specific attitudes, behaviors and plans to commit suicide. Score range 0-42, with higher score indicating higher intensity.|baseline and 24 hours post infusion|||units on a scale||Standard Deviation|Mean
685138|NCT01507090|Primary|Equivalence of the Mercy Method and the 2D and 3D Mercy TAPEs (Concordance Corelation Coefficient)|Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with weight generated by the Mercy method (kg). Outcome measures reported below reflect the intercept of the regression equation comparing method predicted vs. TAPE predicted weight.|study day 1|Final population for data analysis.||unitless||95% Confidence Interval|Number
685126|NCT01507155|Secondary|Efficacy Measured by QIDS-SR16, Q-LES-Q-SF, UKU Side Effects; and SAS at 3 Months|"To determine the efficacy of assay-guided treatment (AGT) in terms of illness severity as measured by change from baseline in self-reported patients scales:
Quick Inventory of Depressive Symptoms (QIDS-SR16) scale; scores range from 0-27, 0 means no depression and 27 means very severe depression
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF) scale; scores range from 0-100 and greater scores correspond with greater satisfaction with quality of life
Undersøgelser (UKU) scale that measures degree of side effects from total scores ranging from 0-100; 0-40 refers to low side effects and 81-100 referring to high side effects rating
the Zung Self-Rated Anxiety (SAS) scale measures anxiety severity using the total scores ranging from 20-80; 20-44 being normal and 75-80 meaning most severe"|3 months|Only 197 patients completed self-assessments at 3 months.||Scores on a scale||Standard Deviation|Mean
685127|NCT01507155|Primary|Change From Baseline in Clinical Global Impressions Improvement (CGI-I) Scale at 3 Months|To determine the efficacy of assay-guided treatment (AGT) in terms of illness severity, as measured by change from baseline using the clinician-administered CGI-I scale, which ranges from scores 1-7 (1=very much improved, 7=very much worse since initiation of treatment).|3 months|||Participants|||Number
685128|NCT01507103|Primary|Change From Baseline in IFN-gamma Secretion of Mononuclear Cells in Response to Carcinoembryonic Antigen (CEA) by ELISpot at Post-baseline|IFN-gamma secretion of mononuclear cells in response to CEA was to be measured by ELISpot. The maximal post-baseline value out of Week 5, Week 11-13 (pre-surgery), and Week 16-18 (follow-up / end-of trial) was evaluated in comparison to Baseline.|Baseline, Week 5, Week 13 (pre-surgery), and Week 18 (end-of trial)|Data were not analyzed as no acceptable ELISpot assay is available|||||
685129|NCT01507103|Secondary|Change From Baseline in Immunological Response in Peripheral Blood at Week 18 (Follow-up / end-of Trial)|Immunological changes in peripheral blood were evaluated based on fluorescence analysis cell sorter phenotypic characterization of T cells (CD3+CD4+ and CD3+CD8+) and of markers of activation and proliferation (CD27, BTLA); and regulatory cells such as CD3+CD4+ (or CD8+) CD45RA+CD25+FoxP3+CD127 T cells. Immunological Response in peripheral blood was measured on a continuous scale.|Baseline and Week 18 (follow-up / end-of trial)|Immunomonitoring analysis set included all subjects for whom at least the baseline ELISpot blood and tumor sample, tumor sample at surgery and pre-surgery ELISpot blood drawing are available and whose tumor biopsy at baseline is MUC1-positive. Within the data table, n=number of subjects analysed for each category.||log2 (percentage of T cells)||Standard Deviation|Mean
685130|NCT01507103|Secondary|Change From Baseline in Peritumoral Immune Response at Week 14 (Post-surgery)|Immunological changes in the tumor microenvironment were evaluated based on IHC expression of CD3+, CD4+, and Ki67+CD3+ T cells; regulatory T cells (FOXP3+) and myeloid-derived suppressor cells (CD33+CD14-); other immune cells such as NK cells (CD3-CD57+), B cells (CD20+), macrophages (CD68+), and dendritic cells (S100+). Peritumoral immune response was calculated as number of lymphoid cells at the margin of the tumor or in the tumor bed (if there is complete pathological response).|Baseline and Week 14 (post-surgery)|The pre-specified statistical threshold for reporting of results of planned analysis for either arm or interaction effect was not met in the analysis population. Hence the data was not assessed for the outcome measure.|||||
685131|NCT01507103|Primary|Change From Baseline in Interferon (IFN)-Gamma Secretion of Mononuclear Cells in Response to MUC1 by Enzyme-linked Immunosorbent Spot (ELISpot) at Post-baseline|IFN-gamma secretion of mononuclear cells in response to MUC1 was to be measured by ELISpot. The maximal post-baseline value out of Week 5, Week 11-13 (pre-surgery), and Week 16-18 (follow-up / end-of trial) was evaluated in comparison to Baseline.|Baseline, Week 5, Week 13 (pre-surgery), and Week 18 (end-of trial)|Data were not analyzed as no acceptable ELISpot assay is available|||||
685132|NCT01507103|Primary|Immunological Response to Treatment in Relation to Microsatellite Instability (MSI) Status: Number of Subjects Per MSI Category|A potential association between MSI status (present or absent) and the primary endpoints (difference from baseline to surgery in CD8+ and CD8+/GrB+ T cell infiltration) was evaluated. Determination of mismatch repair protein (MRP)-expression (hMLH1, hMSH2, hMSH6 and hPMS2) was performed for the detection of the MSI-H-phenotype by IHC and/or on tumor deoxyribonucleic acid (DNA) sample using 5 microsatellite markers (BAT-25, BAT-26, NR-21, NR-24 and MONO-27).|18 weeks|Immunomonitoring analysis set included all subjects for whom at least the baseline ELISpot blood and tumor sample, tumor sample at surgery and pre-surgery ELISpot blood drawing are available and whose tumor biopsy at baseline is MUC1-positive.||subjects|||Number
685133|NCT01507103|Primary|Change From Baseline in Tumor Immune Response Evaluated by Immunohistochemical (IHC) Analysis of Tumor Infiltrating Lymphocytes (TILs) at Week 14 (Post-surgery)|Tumor biopsy samples were collected prior to baseline and after the surgery. The TILs were evaluated in 3 of the most abundant high-power fields (x40) per sample and the mean value considered (after excluding the lowest and the highest value). The tumor immune response was calculated as number of TILs divided by 100 tumor cells.|Baseline and Week 14 (post-surgery)|Immunomonitoring analysis set included all subjects for whom at least the baseline ELISpot blood and tumor sample, tumor sample at surgery and pre-surgery ELISpot blood drawing are available and whose tumor biopsy at baseline is MUC1-positive. Within the data table, n=number of subjects analyzed for each category.||TILs per 100 tumor cells||Standard Deviation|Mean
685134|NCT01507090|Secondary|Predictive Performance of the Mercy Method|Evaluate the weight generated by the Mercy method (kg) with the actual weight (kg)|study day 1|Final population for data analysis.||root mean square error (kg)|||Number
685135|NCT01507090|Secondary|Predictive Performance of the Mercy Method|Evaluate the weight generated by the Mercy method (kg) with the actual weight (kg)|study day 1|Final population for data analysis.||correlation coefficieint|||Number
685136|NCT01507090|Secondary|Predictive Performance of the Mercy Method (Mean Percentage Error)|Evaluate the weight generated by the Mercy method (kg) with the actual weight (kg)|study day 1|Final population for data analysis.||percentage error||Standard Deviation|Mean
685137|NCT01507090|Primary|Equivalence of the Mercy Method and the 2D and 3D Mercy TAPEs (% Within 10%)|Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with weight generated by the Mercy method (kg). Outcome measures reported below reflect the percentage weight estimations using the Mercy TAPEs that are within 10% of the weight estimations using the Mercy Method.|study day 1|Final population for data analysis.||percent of estimations||95% Confidence Interval|Number
685139|NCT01507090|Primary|Equivalence of the Mercy Method and the 2D and 3D Mercy TAPEs (Ratio)|Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with weight generated by the Mercy method (kg). Outcome measures reported below reflect the slope of the regression equation comparing method predicted vs. TAPE predicted weight.|study day 1|Final population for data analysis.||unitless||95% Confidence Interval|Number
685140|NCT01507090|Primary|Predictive Performance of the Mercy TAPE|Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with the actual weight (kg)|study day 1|Final population for data analysis||root mean square error (kg)|||Number
685141|NCT01507090|Primary|Predictive Performance of the Mercy TAPE (Corelation Coefficient)|Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with the actual weight (kg)|study day 1|Final population for data analysis||correlation coefficient|||Number
685142|NCT01507090|Secondary|Predictive Performance of the Mercy Method (Mean Error)|Evaluate the weight generated by the Mercy method (kg) with the actual weight (kg)|study day 1|Final population for data analysis.||kilograms||Standard Deviation|Mean
685143|NCT01507090|Secondary|Predictive Performance of the Mercy Method (Percent of Participants)|Evaluate the weight generated by the Mercy method (kg) with the actual weight (kg). The outcome measure below relfects the percent of participants with weight estimated within within 20% of actual weight.|study day 1|||percent of participants||95% Confidence Interval|Number
685144|NCT01507090|Secondary|Predictive Performance of the Mercy Method (Slope)|Evaluate the weight generated by the Mercy method (kg) with the actual weight (kg)|study day 1|||unitless||95% Confidence Interval|Number
685145|NCT01507090|Secondary|Predictive Performance of the Mercy Method (Intercept)|Evaluate the weight generated by the Mercy method (kg) with the actual weight (kg)|study day 1|||kilograms||95% Confidence Interval|Number
685146|NCT01507090|Secondary|Device Print Batch Variability|"Geometric mean of the ratio (CV) of true to estimated weight calculated by TAPE version. Mercy TAPEs were printed in 2 batches numbers 1 and 2 accordingly."|study day 1|||ratio||Geometric Coefficient of Variation|Geometric Mean
685147|NCT01507090|Primary|Predictive Performance of the Mercy TAPE (Mean Percentage Error)|Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with the actual weight (kg)|study day 1|Final population for data analysis||percentage error||Standard Deviation|Mean
685148|NCT01507090|Primary|Predictive Performance of the Mercy TAPE (Mean Error)|Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with the actual weight (kg)|study day 1|Final population for data analysis||kilograms||Standard Deviation|Mean
685149|NCT01507090|Primary|Predictive Performance of the Mercy TAPE (Intercept)|Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with the actual weight (kg). Outcome measures reported below reflect the intercept of the regression equation comparing observed vs. predicted weight.|study day 1|Final population for data analysis.||kilograms||95% Confidence Interval|Number
685150|NCT01507090|Secondary|Inter-rater Reliability for the 2D and 3D Mercy TAPEs.|Intraclass correlation coefficient|study day 1|All pre-qualified study coordinators||Intraclass correlation coefficient|||Number
685151|NCT01507090|Primary|Predictive Performance of the Mercy TAPE (Slope)|Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with the actual weight (kg). Outcome measures reported below reflect the slope of the regression equation comparing observed vs. predicted weight.|study day 1|Final population for data analysis.||unitless||95% Confidence Interval|Number
685152|NCT01507090|Primary|Predictive Performance of the Mercy TAPE (Percent of Participants Predicted Within 20% of Their Actual Weight)|Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with the actual weight (kg). Outcome measures reported below reflect the percentage of participants whose weight estimations using the Mercy TAPEs are within 20% of their actual weight.|study day 1|Final population for data analysis.||percentage of participants||95% Confidence Interval|Number
685153|NCT01507051|Secondary|Drug Concentration in Plasma at Steady State at Expected Time of Minimum (Trough) Concentration, Normalized by Dose (Ctrough,ss/D) of S-warfarin After the Last Dose of Warfarin|Ctrough,ss/D refers to the drug concentration at steady state at the time when it is expected to reach its minimum (trough) concentration, normalized by dose.|0 h (predose) and 24 h after the last administration of warfarin|PK/PD set||1/Liter||Geometric Coefficient of Variation|Geometric Mean
685154|NCT01507051|Secondary|Drug Concentration in Plasma at Steady State at Expected Time of Minimum (Trough) Concentration (Ctrough,ss) of S-warfarin After the Last Dose of Warfarin|Ctrough,ss refers to the drug concentration at steady state at the time when it is expected to reach its minimum (trough) concentration.|0 h (predose) and 24 h after the last administration of warfarin|PK/PD set||Microg/L||Geometric Coefficient of Variation|Geometric Mean
685155|NCT01507051|Secondary|Drug Concentration in Plasma at Steady State at Expected Time of Minimum (Trough) Concentration, Normalized by Dose (Ctrough,ss/D) of R-warfarin After the Last Dose of Warfarin|Ctrough,ss/D refers to the drug concentration at steady state at the time when it is expected to reach its minimum (trough) concentration, normalized by dose.|0 h (predose) and 24 h after the last administration of warfarin|PK/PD set||1/Liter||Geometric Coefficient of Variation|Geometric Mean
685156|NCT01507051|Secondary|Drug Concentration in Plasma at Steady State at Expected Time of Minimum (Trough) Concentration (Ctrough,ss) of R-warfarin After the Last Dose of Warfarin|Ctrough,ss refers to the drug concentration at steady state at the time when it is expected to reach its minimum (trough) concentration.|0 h (predose) and 24 h after the last administration of warfarin|PK/PD set||Microg/L||Geometric Coefficient of Variation|Geometric Mean
685157|NCT01507051|Secondary|Half Life Associated With Terminal Slope (t1/2) of Rivaroxaban After Last Dose|Half-life refers to the elimination of the drug, i.e. the time it takes for the blood plasma concentration to reach half the concentration in the terminal phase of elimination.|3, 24, 48, and 72 h after the last administration of rivaroxaban|PK/PD set; derived parameter could not be evaluated for all participants.||hours||Geometric Coefficient of Variation|Geometric Mean
685158|NCT01507051|Secondary|Drug Concentration in Plasma at Expected Time of Minimum (Trough) Concentration (Ctrough) of Rivaroxaban After Second to Fourth Dose|Ctrough refers to the time after dosing when the drug concentration is expected to reach its minimum (trough) concentration.|Always 24 h after the second, third, and fourth dose|PK/PD set||Microg/L||Geometric Coefficient of Variation|Geometric Mean
685401|NCT01500772|Secondary|Percentage of Participants With HCV RNA Laboratory Value Below Level of Detection 12 Weeks After the End of Treatment (SVR12-LOD)|Level of detection (LOD) was defined as 10 IU/mL|12 weeks posttreatment|The study was terminated before the outcome measure time point.|||||
685159|NCT01507051|Secondary|Drug Concentration in Plasma at Expected Time of Maximum (Peak) Concentration (Cpeak) of Rivaroxaban After Second to Fourth Dose|Cpeak refers to the time after dosing when the drug concentration is expected to reach its maximum (peak) concentration.|Always 3 h after second, third, and fourth dose|PK/PD set||Microg/L||Geometric Coefficient of Variation|Geometric Mean
685160|NCT01507051|Secondary|Time to Reach Maximum Drug Concentration in Plasma (Tmax) of Rivaroxaban After First Dose|Tmax refers to the time after dosing when a drug attains its highest measurable concentration (Cmax). It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban|PK/PD set||hours||Full Range|Median
685161|NCT01507051|Secondary|Maximum Drug Concentration in Plasma Divided by Dose Per kg Body Weight (Cmax,Norm) of Rivaroxaban After First Dose|Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample; Cmax,norm is defined as Cmax divided by dose (mg) per kg body weight.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban|PK/PD set||Kg/L||Geometric Coefficient of Variation|Geometric Mean
685162|NCT01507051|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hours Divided by Dose Per kg Body Weight [AUC(0-24)Norm] of Rivaroxaban After First Dose|The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample; [AUC(0-24)norm] is defined as AUC divided by dose per kg body weight from zero to 24 hours after first (single) dose.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban|PK/PD set||Kg*h/L||Geometric Coefficient of Variation|Geometric Mean
685163|NCT01507051|Secondary|Half Life Associated With Terminal Slope (t1/2) of S-warfarin After the Last Dose of Warfarin|Half-life refers to the elimination of the drug, i.e. the time it takes for the blood plasma concentration to reach half the concentration in the terminal phase of elimination.|Blood samples taken at 24, 30, 48, 54, 72, 96, and 120 h after the last administration of warfarin|PK/PD set||hours||Geometric Coefficient of Variation|Geometric Mean
685164|NCT01507051|Secondary|Half Life Associated With Terminal Slope (t1/2) of R-warfarin After the Last Dose of Warfarin|Half-life refers to the elimination of the drug, i.e. the time it takes for the blood plasma concentration to reach half the concentration in the terminal phase of elimination.|Blood samples taken at 24, 30, 48, 54, 72, 96, and 120 h after the last administration of warfarin|PK/PD set||hours||Geometric Coefficient of Variation|Geometric Mean
685165|NCT01507051|Secondary|Maximum Drug Concentration in Plasma (Cmax) of Rivaroxaban After First Dose|Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban|PK/PD set||microg/L||Geometric Coefficient of Variation|Geometric Mean
685166|NCT01507051|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hours [AUC(0-24)] of Rivaroxaban After First Dose|The AUC is a measure of systemic drug exposure which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample ([AUC(0-24)] is defined as area under the concentration vs. time curve from zero to 24 hours after first (single) dose).|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban|PK/PD set||microg*h/L||Geometric Coefficient of Variation|Geometric Mean
685167|NCT01507051|Secondary|AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of Factor IIa Activity|Factor II (Thrombin) is a coagulation factor that is required for the coagulation process. AUC(0-tn) of Factor IIa activity was the area under the measurement (Factor IIa activity [measured as percent of actual Factor IIa activity compared to Factor IIa activity in reference plasma] at baseline divided by Factor IIa activity [measured as percent of actual Factor IIa activity compared to Factor IIa activity in reference plasma] at different time-points) versus time curve from time 0 to the last data point.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set; derived parameter could not be evaluated for all participants.||ratio*h||Geometric Coefficient of Variation|Geometric Mean
685168|NCT01507051|Secondary|Emax (Maximum Effect) on Factor IIa Activity|Factor II (Thrombin) is a coagulation factor that is required for the coagulation process. Emax on Factor IIa activity was measured as the ratio of Factor IIa activity (measured as percent of actual Factor IIa activity compared to Factor IIa activity in reference plasma) at baseline divided by minimum Factor IIa activity (measured as percent of actual Factor IIa activity compared to Factor IIa activity in reference plasma).|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set||ratio||Geometric Coefficient of Variation|Geometric Mean
685169|NCT01507051|Secondary|AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of Factor VIIa Activity|Factor VII is a coagulation factor that is required for the coagulation process. AUC(0-tn) of Factor VIIa activity was the area under the measurement (Factor VIIa activity [measured as percent of actual Factor VIIa activity compared to Factor VIIa activity in reference plasma] at baseline divided by Factor VIIa activity [measured as percent of actual Factor VIIa activity compared to Factor VIIa activity in reference plasma] at different time-points) versus time curve from time 0 to the last data point.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set||ratio*h||Geometric Coefficient of Variation|Geometric Mean
685170|NCT01507051|Secondary|Emax (Maximum Effect) on Factor VIIa Activity|Factor VII is a coagulation factor that is required for the coagulation process. Emax on Factor VIIa activity was measured as the ratio of Factor VIIa activity (measured as percent of actual Factor VIIa activity compared to Factor VIIa activity in reference plasma) at baseline divided by minimum Factor VIIa activity (measured as percent of actual Factor VIIa activity compared to Factor VIIa activity in reference plasma).|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set||ratio||Geometric Coefficient of Variation|Geometric Mean
685207|NCT01506947|Primary|Mean Erythropoietin Dose Per Visit|The requirement of erythropoietin (EPO) treatment to maintain serum hemoglobin levels between 10 to 11.5 g/dL during the study was assessed by analysis of the dose of darbepoetin alfa used at baseline and during each month of the study. The mean EPO dosage per injection for each study month is reported.|Baseline and Months 1, 2, 3, 4, 5 and 6|Per-protocol analysis set with EPO dosage available at all visits.||µg||Standard Deviation|Mean
685171|NCT01507051|Secondary|AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of ETP (Endogenous Thrombin Potential) Peak Time|ETP peak time assesses the overall function of the clotting cascade. The peak time assesses the time required to reach the maximal thrombin generation. Increasing values compared to baseline indicate an anticoagulant effect. AUC(0-tn) of ETP peak time was the area under the measurement (ETP peak time [measured in minutes as time to reach the maximum coagulation activity] at different time-points divided by ETP peak time [measured in minutes as time to reach the maximum coagulation activity] at baseline) versus time curve from time 0 to the last data point.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set||ratio*h||Geometric Coefficient of Variation|Geometric Mean
685172|NCT01507051|Secondary|Emax (Maximum Effect) on ETP (Endogenous Thrombin Potential) Peak Time|ETP peak time assesses the overall function of the clotting cascade. The peak time assesses the time required to reach the maximal thrombin generation. Increasing values compared to baseline indicate an anticoagulant effect. Emax on ETP peak time was measured as the ratio of maximum ETP peak time (measured in minutes as time to reach the maximum coagulation activity) divided by ETP peak time (measured in minutes as time to reach the maximum coagulation activity) at baseline.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set||ratio||Geometric Coefficient of Variation|Geometric Mean
685173|NCT01507051|Secondary|AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of ETP (Endogenous Thrombin Potential) Peak|ETP peak assesses the overall function of the clotting cascade. The peak assesses the overall maximal ability to generate thrombin. Decreasing values compared to baseline indicate an anticoagulant effect. AUC(0-tn) of ETP peak was the area under the measurement (ETP peak [measured in nm as maximum coagulation activity] at baseline divided by ETP peak measured [in nm as maximum coagulation activity] at different time-points) versus time curve from time 0 to the last data point.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set||ratio*h||Geometric Coefficient of Variation|Geometric Mean
685174|NCT01507051|Secondary|Emax (Maximum Effect) on ETP (Endogenous Thrombin Potential) Peak|ETP peak assesses the overall function of the clotting cascade. The peak assesses the overall maximal ability to generate thrombin. Decreasing values compared to baseline indicate an anticoagulant effect. Emax on ETP peak was measured as the ratio of ETP peak (measured in nm as maximum coagulation activity) at baseline divided by minimum ETP peak (measured in nm as maximum coagulation activity).|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set||ratio||Geometric Coefficient of Variation|Geometric Mean
685175|NCT01507051|Secondary|AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of ETP (Endogenous Thrombin Potential) Lag Time|ETP lag time assesses the overall function of the clotting cascade. The lag time assesses the time required until thrombin is generated. Increasing values compared to baseline indicate an anticoagulant effect. AUC(0-tn) of ETP lag time was the area under the measurement (ETP lag time [in minutes as measure for the start of coagulation] at different time-points divided by ETP lag time [in minutes as measure for the start of coagulation] at baseline) versus time curve from time 0 to the last data point.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set||ratio*h||Geometric Coefficient of Variation|Geometric Mean
685176|NCT01507051|Secondary|Emax (Maximum Effect) on ETP (Endogenous Thrombin Potential) Lag Time|ETP lag time assesses the overall function of the clotting cascade. The lag time assesses the time required until thrombin is generated. Increasing values compared to baseline indicate an anticoagulant effect. Emax on ETP lag time was measured as the ratio of maximum ETP lag time (in minutes as measure for the start of coagulation) divided by ETP lag time (in minutes as measure for the start of coagulation) at baseline.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set||ratio||Geometric Coefficient of Variation|Geometric Mean
685177|NCT01507051|Secondary|AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of ETP (Endogenous Thrombin Potential) AUC|ETP AUC assesses the overall function of the clotting cascade. The AUC assesses the overall ability to generate thrombin. Decreasing values compared to baseline indicate an anticoagulant effect. AUC(0-tn) of ETP AUC was the area under the measurement (ETP AUC [measured in nm*min as integral of fluorescence measurements] at baseline divided by ETP AUC [measured in nm*min as integral of fluorescence measurements] at different time-points) versus time curve from time 0 to the last data point.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set||ratio*h||Geometric Coefficient of Variation|Geometric Mean
685178|NCT01507051|Secondary|Emax (Maximum Effect) on ETP (Endogenous Thrombin Potential) AUC|ETP AUC assesses the overall function of the clotting cascade. The AUC assesses the overall ability to generate thrombin. Decreasing values compared to baseline indicate an anticoagulant effect. Emax on ETP AUC was measured as the ratio of ETP AUC (measured in nm*min as integral of fluorescence measurements) at baseline divided by minimum ETP AUC (measured in nm*min as integral of fluorescence measurements).|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set||ratio||Geometric Coefficient of Variation|Geometric Mean
685179|NCT01507051|Secondary|AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of PiCT (Prothrombinase-induced Clotting Time)|This coagulation test can be adapted to measure different anticoagulants, including inhibitors of Factor X. Higher values than the baseline indicate anticoagulant effects. AUC(0-tn) of PiCT was the area under the measurement (PiCT [measured in seconds] at different time-points divided by PiCT [measured in seconds] at baseline) versus time curve from time 0 to the last data point.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set; derived parameter could not be evaluated for all participants.||ratio*h||Geometric Coefficient of Variation|Geometric Mean
685180|NCT01507051|Secondary|Emax (Maximum Effect) on PiCT (Prothrombinase-induced Clotting Time)|This coagulation test can be adapted to measure different anticoagulants, including inhibitors of Factor X. Higher values than the baseline indicate anticoagulant effects. Emax on PiCT was measured as the ratio of maximum PiCT (measured in seconds) divided by PiCT (measured in seconds) at baseline.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set; derived parameter could not be evaluated for all participants.||ratio||Geometric Coefficient of Variation|Geometric Mean
685181|NCT01507051|Secondary|AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of HepTest (Coagulation Test)|This coagulation test was developed to monitor heparin and especially low-molecular weight heparins (LMWH). It is sensitive to measure Factor X. Higher values than the baseline indicate anticoagulant effects. AUC(0-tn) of HepTest was the area under the measurement (HepTest [measured in seconds] at different time-points divided by HepTest [measured in seconds] at baseline) versus time curve from time 0 to the last data point.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set; derived parameter could not be evaluated for all participants.||ratio*h||Geometric Coefficient of Variation|Geometric Mean
685182|NCT01507051|Secondary|Emax (Maximum Effect) on HepTest (Coagulation Test)|This coagulation test was developed to monitor heparin and especially low-molecular weight heparins (LMWH). It is sensitive to measure Factor X. Higher values than the baseline indicate anticoagulant effects. Emax on HepTest was measured as the ratio of maximum HepTest (measured in seconds) divided by HepTest (measured in seconds) at baseline.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set; derived parameter could not be evaluated for all participants.||ratio||Geometric Coefficient of Variation|Geometric Mean
685183|NCT01507051|Secondary|AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of aPTT (Activated Partial Thromboplastin Time)|The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V, VIII, IX, X, XI and XII. Higher values than the baseline indicate anticoagulant effects. AUC(0-tn) of aPTT was the area under the measurement (aPTT [measured in seconds] at different time-points divided by aPTT [measured in seconds] at baseline) versus time curve from time 0 to the last data point.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set||ratio*h||Geometric Coefficient of Variation|Geometric Mean
685184|NCT01507051|Secondary|Emax (Maximum Effect) on aPTT (Activated Partial Thromboplastin Time)|The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V, VIII, IX, X, XI and XII. Higher values than the baseline indicate anticoagulant effects. Emax on aPTT was measured as the ratio of maximum aPTT (measured in seconds) divided by aPTT (measured in seconds) at baseline.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set||ratio||Geometric Coefficient of Variation|Geometric Mean
685185|NCT01507051|Secondary|AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of Anti-Factor Xa Activity|This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method. Higher Values than the baseline indicate a more pronounced inhibition. AUC(0-tn) of anti-Factor Xa activity was the area under the measurement (anti-Factor Xa activity [measured in U/L] at different time-points divided by anti-Factor Xa activity [measured in U/L] at baseline) versus time curve from time 0 to the last data point.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set; derived parameter could not be evaluated for all participants.||ratio*h||Geometric Coefficient of Variation|Geometric Mean
685186|NCT01507051|Secondary|Emax (Maximum Effect) on Anti-Factor Xa Activity|This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method. Higher Values than the baseline indicate a more pronounced inhibition. Emax on anti-Factor Xa activity was measured as the ratio of maximum anti-Factor Xa activity (measured in U/L) divided by anti-Factor Xa activity (measured in U/L) at baseline.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set; derived parameter could not be evaluated for all participants.||ratio||Geometric Coefficient of Variation|Geometric Mean
685187|NCT01507051|Secondary|AUC(0-tn) (Area Under the Inverse Measurement Versus Time Curve From Time 0 to the Last Data Point) of Factor Xa Activity|Test to measure the activity of endogenous Factor Xa. AUC(0-tn) of Factor Xa activity was the area under the inverse measurement [100*(Factor Xa activity at baseline (measured as activity per mL) - Factor Xa activity (measured as activity per mL) at different time-points) / Factor Xa activity at baseline (measured as activity per mL)] versus time curve from time 0 to the last data point.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set||Percentage of inhibition*h||Geometric Coefficient of Variation|Geometric Mean
685188|NCT01507051|Secondary|Emax on Factor Xa Activity|Test to measure the activity of endogenous Factor Xa. Emax on Factor Xa activity was calculated as 100*(Factor Xa activity at baseline [measured as activity per mL] - minimum of Factor Xa activity [measured as activity per mL]) / Factor Xa activity at baseline [measured as activity per mL].|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set||Percentage of inhibition||Geometric Coefficient of Variation|Geometric Mean
685189|NCT01507051|Secondary|AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) for PT (Measured as INR=International Normalized Ratio)|Prothrombin time – INR measured in seconds that is calculated as INR which is a correction for PT assay differences and an optimization to measure vitamin K antagonists. Higher values than the baseline indicate anticoagulant effects. AUC(0-tn) of PT (INR) was the area under the measurement (PT measured as INR at different time-points divided by PT measured as INR at baseline) versus time curve from time 0 to the last data point.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set||ratio*h||Geometric Coefficient of Variation|Geometric Mean
685190|NCT01507051|Secondary|Emax on PT (Measured as INR=International Normalized Ratio)|Prothrombin time – INR measured in seconds that is calculated as INR which is a correction for PT assay differences and an optimization to measure vitamin K antagonists. Higher values than the baseline indicate anticoagulant effects. Emax on PT (INR) was measured as the ratio of maximum INR divided by baseline INR.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set||ratio||Geometric Coefficient of Variation|Geometric Mean
685206|NCT01506947|Secondary|Mean Scores of Short Form Health Survey 36 (SF-36) Questionnaire|The Medical Outcome Study Short Form 36-Item Health Survey (SF-36) is a self-administered questionnaire that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains. The domains include physical (physical functioning, role limitations due to physical health (role-physical), general health perceptions and pain) and mental domains (energy/fatigue (vitality), social functioning, emotional well-being (mental health), and role limitations due to emotional problems (role emotional)). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning.|Baseline and Month 6|Per-protocol analysis set||units on a scale||Standard Deviation|Mean
685191|NCT01507051|Secondary|AUCBA(0-tn) (Baseline Adjusted Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of Prothrombin Time (Coagulation Test)|Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds. Higher values than the baseline indicate anticoagulant effects. AUCBA(0-tn) of PT was the area under the measurement (PT [measured in seconds] at different time-points minus PT [measured in seconds] at baseline) versus time curve from time 0 to the last data point.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set||s*h||Geometric Coefficient of Variation|Geometric Mean
685192|NCT01507051|Secondary|AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of Prothrombin Time (Coagulation Test)|Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds. Higher values than the baseline indicate anticoagulant effects. AUC(0-tn) of PT was the area under the measurement (PT [measured in seconds] at different time-points divided by PT [measured in seconds] at baseline) versus time curve from time 0 to the last data point.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set||ratio*h||Geometric Coefficient of Variation|Geometric Mean
685193|NCT01507051|Primary|Emax,BA (Baseline Adjusted Maximum Effect) on Prothrombin Time (Coagulation Test)|Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds. Higher values than the baseline indicate anticoagulant effects. Emax,BA on PT was measured as maximum PT (measured in seconds) minus PT (measured in seconds) at baseline.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set||seconds||Geometric Coefficient of Variation|Geometric Mean
685194|NCT01507051|Primary|Emax (Maximum Effect) on Prothrombin Time (PT) (Coagulation Test)|Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds. Higher values than the baseline indicate anticoagulant effects. Emax on PT was measured as the ratio of maximum PT (measured in seconds) divided by PT (measured in seconds) at baseline.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set||ratio||Geometric Coefficient of Variation|Geometric Mean
685195|NCT01506960|Secondary|Differences in NIRS Parameters Between Deep and Superficial Lipid Assessed by Optical Coherence Tomography (OCT).|Subjects are presenting for their clinically-indicated cardiac catheterization. NIRS/IVUS imaging will be done at the time of catheterization. Plaques were divided depending on depth of lipid by OCT (cut off value 130 um).|Measured at the time of cardiac catheterization|Per protocol||mm (LCP length)|Participants|Standard Deviation|Mean
685196|NCT01506960|Primary|Detection of Lipid Rich Plaque by Near Infrared Spectroscopy (NIRS) Intravascular Ultrasound (IVUS)|Subjects are presenting for their clinically-indicated cardiac catheterization. NIRS/IVUS imaging will be done at the time of catheterization.|Measured one point in time during cardiac catheterization|||% pts with lipid on NIRS and OCT|||Number
685197|NCT01506947|Secondary|Number of Participants With Adverse Events|"Serious adverse events were any adverse events meeting any of the following criteria:
An event that resulted in the death of a participant;
An event that, in the opinion of the investigator, would have resulted in immediate fatality if medical intervention had not been taken (life-threatening);
Resulted in an admission to the hospital for any length of time or prolonged hospital stay;
An anomaly detected at or after birth, or any anomaly that results in fetal loss;
An event that resulted in a condition that substantially interfered with the activities of daily living;
An important medical event that may not be immediately life-threatening or result in death or hospitalization, but based on medical judgment may have jeopardized the participant and may have required medical or surgical intervention to prevent any of the outcomes listed above.
Adverse events were assessed by the investigator for possible relationship to study drug."|From the time of study drug administration until 4 weeks after the discontinuation of the study drug; up to 7 months.|The safety population included all participants who enrolled.||participants|||Number
685198|NCT01506947|Secondary|Mean Fibroblast Growth Factor-23 (FGF-23) Level at Baseline and Month 6||Baseline and Month 6|Per-protocol analysis set with available data at each time point.||kRU/L||Standard Deviation|Mean
685199|NCT01506947|Secondary|Mean High Sensitivity C-reactive Protein (hsCRP) Level at Baseline and Month 6||Baseline and Month 6|Per-protocol analysis set with available data at each time point.||mg/mL||Standard Deviation|Mean
685200|NCT01506947|Secondary|Folic Acid Levels|"Folic acid levels were categorized according to the following laboratory reference ranges:
Low: < 4.6 ng/mL Normal: 4.6 – 18.7 ng/mL High: > 18.7 ng/mL"|Baseline and month 6|Per-protocol analysis set with available data at each time point.||Participants|||Count of Participants
685201|NCT01506947|Secondary|Vitamin B12 Levels|"Vitamin B12 levels were categorized according to the following laboratory reference ranges:
Low: < 200 pg/mL Normal: 200 – 950 pg/mL High: > 950 pg/mL"|Baseline and month 6|Per-protocol analysis set with available data at each time point.||Participants|||Count of Participants
685202|NCT01506947|Secondary|Mean Alkaline Phosphatase Level at Baseline and Month 6||Baseline and Month 6|Per-protocol analysis set with available data at each time point.||U/L||Standard Deviation|Mean
685203|NCT01506947|Secondary|Mean Phosphorus Level at Baseline and Month 6||Baseline and Month 6|Participants who completed the study with available data at each time point.||mg/mL||Standard Deviation|Mean
685204|NCT01506947|Secondary|Mean Calcium Level at Baseline and Month 6||Baseline and Month 6|Per-protocol analysis set with available data at each time point.||mg/mL||Standard Deviation|Mean
685205|NCT01506947|Secondary|Mean Intact Parathyroid Hormone (iPTH) Level at Baseline and Month 6||Baseline and Month 6|Per-protocol analysis set with available data at each time point.||pg/mL||Standard Deviation|Mean
685402|NCT01500772|Secondary|Percentage of Participants Who Achieved SVR 24 Weeks After the End of Treatment (SVR24)|SVR24 was defined as HCV RNA laboratory value < LOQ 24 weeks after the end of treatment.|24 weeks posttreatment|The study was terminated before the outcome measure time point.|||||
685208|NCT01506908|Secondary|Number of Participants With Adverse Events (AEs), Treatment Related AEs, and Serious AEs (SAEs)|AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with study treatment/s. Treatment related AE was defined as any AE considered to be possibly, probably or highly probably related to study medication. SAE was defined as any untoward medical occurrence that at any dose results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization results in disability/ incapacity; is a congenital anomaly/ birth defect.|Baseline to Day 5 post treatment administration|Safety population: All randomized participants who received the study treatments were considered evaluable for safety.||Participants|||Number
685209|NCT01506908|Secondary|Change From Post-cue Baseline in Nicotine Craving Score at 10 Minutes|Participants completed a nicotine craving assessment consisting of following five items: I have a desire for a cigarette right now, if it were possible I would smoke right now, All I want right now is a cigarette, I have an urge for a cigarette, I crave a cigarette right now. All participants indicated their craving intensity on a pre-drawn 100 mm scale ranging from 0 (disagree) to 100 (agree). At the end of the craving assessment period, mean VAS score was measured.|Post-Cue Baseline, 10 minutes post treatment administration|ITT population: All randomized participants who had at least one cravings assessment measurement post dose. The imputation of missing craving score was based on LOCF technique||Score on a scale||95% Confidence Interval|Least Squares Mean
685210|NCT01506908|Secondary|Change From Post-cue Baseline in Nicotine Craving Score at 7 Minutes|Participants completed a nicotine craving assessment consisting of following five items: I have a desire for a cigarette right now, if it were possible I would smoke right now, All I want right now is a cigarette, I have an urge for a cigarette, I crave a cigarette right now. All participants indicated their craving intensity on a pre-drawn 100 mm scale ranging from 0 (disagree) to 100 (agree). At the end of the craving assessment period, mean VAS score was measured.|Post-Cue Baseline, 7 minutes post treatment administration|ITT population: All randomized participants who had at least one cravings assessment measurement post dose. The imputation of missing craving score was based on LOCF technique.||Score on a scale||95% Confidence Interval|Least Squares Mean
685211|NCT01506908|Secondary|Change From Post-cue Baseline in Nicotine Craving Score at 3 Minutes|Participants completed a nicotine craving assessment consisting of following five items: I have a desire for a cigarette right now, if it were possible I would smoke right now, All I want right now is a cigarette, I have an urge for a cigarette, I crave a cigarette right now. All participants indicated their craving intensity on a pre-drawn 100 mm scale ranging from 0 (disagree) to 100 (agree). At the end of the craving assessment period, mean VAS score was measured.|Post-cue Baseline, 3 minutes post treatment administration|ITT population: All randomized participants who had at least one cravings assessment measurement post dose. The imputation of missing craving score was based on LOCF technique.||Score on a scale||95% Confidence Interval|Least Squares Mean
685212|NCT01506908|Secondary|Change From Post-cue Baseline in Nicotine Craving Score at 1 Minute|Participants completed a nicotine craving assessment consisting of following five items: I have a desire for a cigarette right now, if it were possible I would smoke right now, All I want right now is a cigarette, I have an urge for a cigarette, I crave a cigarette right now. All participants indicated their craving intensity on a pre-drawn 100 mm scale ranging from 0 (disagree) to 100 (agree). At the end of the craving assessment period, mean VAS score was measured.|Post-cue baseline, 1 minute post treatment administration|ITT population: All randomized participants who had at least one cravings assessment measurement post dose. The imputation of missing craving score was based on LOCF technique.||Score on a scale||95% Confidence Interval|Least Squares Mean
685213|NCT01506908|Primary|Change From Post-cue Baseline in Nicotine Craving Score at 5 Minutes|Participants completed a nicotine craving assessment consisting of following five items: I have a desire for a cigarette right now, if it were possible I would smoke right now, All I want right now is a cigarette, I have an urge for a cigarette, I crave a cigarette right now. All participants indicated their craving intensity on a pre-drawn 100 mm scale ranging from 0 (disagree) to 100 (agree). At the end of the craving assessment period, mean VAS score was measured.|Post-cue baseline,5 minutes|Intention to Treat (ITT) population: All randomized participants who had at least one cravings assessment measurement post dose. The imputation of missing craving score was based on last observation carried forward (LOCF) technique.||Score on a scale||95% Confidence Interval|Least Squares Mean
685214|NCT01506882|Secondary|Time to Withdrawal in Subjects in the Levetiracetam (LEV) 3000 mg/Day Group|Median time to withdrawal will be estimated from the Kaplan-Meier curve.|During 1-week Stabilization Period, Evaluation, Maintenance and Safety Follow Up Period, assessed up to 1 year|Data for this secondary outcome measure refer to the Full Analysis Set (FAS). FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period.||days||95% Confidence Interval|Median
685215|NCT01506882|Secondary|Time to First Seizure in Subjects in the Levetiracetam (LEV) 3000 mg/Day Group|"Time was measured from first day of last evaluated dose. Seizures during Stabilization were not considered.
The Median time to first seizure will be estimated from the Kaplan-Meier curve."|During Evaluation, Maintenance and Safety Follow Up Period after 1-week Stabilization Period, assessed up to 1 year|Data for this secondary outcome measure refer to the Full Analysis Set (FAS). FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period.||days||95% Confidence Interval|Median
685216|NCT01506882|Secondary|Time to Withdrawal at the Last Evaluated Dose in Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group|Median time to withdrawal will be estimated from the Kaplan-Meier curve.|During 1-week Stabilization Period, Evaluation, Maintenance and Safety Follow Up Period, assessed up to 1 year|Data for this secondary outcome measure refer to the Full Analysis Set (FAS). FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period. This means that subjects in LEV 1000 to 2000 mg/day group had to have at least 1 treatment day in the Evaluation Period on their final evaluated dose.||days||95% Confidence Interval|Median
685233|NCT01506726|Secondary|Change in Cognitive Outcome Measures-Trail Making Test Part B|To quantify the impact of anemia treatment by salsalate on cognitive outcomes based on the Trail Making Test (TMT) Part B as measured by subjects drawing a line from 25 circled numbers to letters in 300 seconds. The change in seconds per completed circle from baseline to month 6.|baseline; 6 months|Two subjects in the active drug oral salsalate group and 3 in the placebo arm group were missing outcome measure.||second per completed circle||Standard Deviation|Mean
685217|NCT01506882|Secondary|Time to First Seizure at the Last Evaluated Dose in Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group|"Time was measured from first day of last evaluated dose. Seizures during Stabilization were not considered.
The Median time to first seizure will be estimated from the Kaplan-Meier curve."|During Evaluation, Maintenance and Safety Follow Up Period after 1-week Stabilization Period, assessed up to 1 year|Data for this secondary outcome measure refer to the Full Analysis Set (FAS). FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period. This means that subjects in LEV 1000 to 2000 mg/day group had to have at least 1 treatment day in the Evaluation Period on their final evaluated dose.||days||95% Confidence Interval|Median
685218|NCT01506882|Secondary|Percentage of Subjects in the Levetiracetam (LEV) 3000 mg/Day Group Who Are Seizure Free for 52 Consecutive Weeks of Treatment During the Evaluation Period and the Maintenance Period|Subjects who complete the 26-weeks Evaluation Period without having a seizure will continue receiving LEV 3000 mg/day during the 26-weeks Maintenance Period unless a seizure occurs.|From entry in the 26-weeks Evaluation Period to the end of the 26-weeks Maintenance Period|Data for this secondary outcome measure refer to the Full Analysis Set (FAS). FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period.||percentage of participants||95% Confidence Interval|Number
685219|NCT01506882|Secondary|Percentage of Subjects in the Levetiracetam (LEV) 3000 mg/Day Group Who Are Seizure Free for 26 Consecutive Weeks of Treatment During the Evaluation Period|"A subject was considered seizure free, if no seizure occurred during the 6 consecutive months (26 weeks) in the Evaluation Period. If one of the following occurred, the subject was not considered seizure free:
A documented seizure during 6 consecutive months of the Evaluation Analysis Period
Subject discontinued the study prematurely during the Evaluation Analysis Period
Missing Seizure Count Case Report Forms (CRFs) prior to completing the Evaluation Analysis Period."|From the end of the 1-week Stabilization Period over the 26-weeks Evaluation Period|Data for this secondary outcome measure refer to the Full Analysis Set (FAS). FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period.||percentage of participants||95% Confidence Interval|Number
685220|NCT01506882|Secondary|Percentage of Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group Who Are Seizure Free for 52 Consecutive Weeks of Treatment During the Evaluation Period and the Maintenance Period|Subjects who complete the 26-weeks Evaluation Period without having a seizure will continue receiving the same dose of LEV as in the Evaluation Period during the 26-weeks Maintenance Period unless a seizure occurs.|From entry in the 26-weeks Evaluation Period to the end of the 26-weeks Maintenance Period|Data for this secondary outcome measure refer to the Full Analysis Set (FAS). FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period. This means that subjects in LEV 1000 to 2000 mg/day group had to have at least 1 treatment day in the Evaluation Period on their final evaluated dose.||percentage of participants||95% Confidence Interval|Number
685221|NCT01506882|Primary|Percentage of Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group Who Are Seizure Free for 26 Consecutive Weeks of Treatment During the Evaluation Period|"A subject was considered seizure free, if no seizure occurred during the 6 consecutive months (26 weeks) in the Evaluation Period. If one of the following occurred, the subject was not considered seizure free:
A documented seizure during 6 consecutive months of the Evaluation Analysis Period
Subject discontinued the study prematurely during the Evaluation Analysis Period
Missing Seizure Count Case Report Forms (CRFs) prior to completing the Evaluation Analysis Period."|From the end of the 1-week Stabilization Period over the 26-weeks Evaluation Period|Data for the primary outcome measure refer to the Full Analysis Set (FAS). FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period. This means that subjects in LEV 1000 to 2000 mg/day group had to have at least 1 treatment day in the Evaluation Period on their final evaluated dose.||percentage of participants||95% Confidence Interval|Number
685222|NCT01506726|Secondary|Assessment of Serum Biomarkers of Erthropoiesis|To assess whether oral salsalate improves serum biomarkers of erythropoiesis by decreasing growth differentiation factor-15 (GDF-15) in UAE subjects. Change in the GDF-15 from prior to study drug to 6 months.|prior to study drug; 6 months|One subject in the active drug oral salsalate arm and two subjects in the placebo arm are missing outcome measures.||pg/ml||Standard Deviation|Mean
685223|NCT01506726|Secondary|Change in Markers of Inflammation|To assess whether oral salsalate reduces C-reactive protein (CRP) in UAE subjects. Change in the CRP from prior to study drug to 6 months.|prior to study drug; 6 months|One subject in the active drug oral salsalate group and two subjects in the placebo arm group were missing outcome measures.||ug/ml||Standard Deviation|Mean
685224|NCT01506726|Secondary|Change in Frailty Component as Determined by the 4 Meter Walk Speed|"To quantify the impact of anemia treatment by salsalate on change in the speed of the 4 meter walk speed. Subjects are asked to walk as fast as they can for 4 meters. Frailty was determined by the subject's speed. (change from frail at baseline to not frail at 6 months). 4 m walking speed is stratified by gender and height. For men, (height of <= 173 cm and a walking speed of <= 0.65 meter/sec) or a (height > 173, <= .76 meter/sec) were classified as frail. For women, (height of <= 159 cm and a walking speed of <=.65 meter/sec) or (height >159 cm <= 0.76 meter/sec) were classified as frail.The outcome is the number of participants who were classified as “frail” at baseline and changed to “not frail” at 6 months."|baseline; 6 months|One subject in the active drug oral salsalate group and 2 in the placebo arm group were missing outcome measure.||participants|||Number
685225|NCT01506726|Secondary|Change in Frailty Component as Determined by Grip Strength|"To quantify the impact of anemia treatment by salsalate on change in the frailty as measured by change in grip strength. Subjects squeeze the grip strength machine 3 times with each hand. For the frailty outcome the maximum grip strength from the dominant hand is used. (change from frail at baseline to not frail at 6 months). Grip strength is stratified by gender and BMI. For men with (BMI <= 24 and a grip strength (GS) <= 29) or (BMI 24.1-28 and grip strength <= 30) or (BMI >28 and a grip strength <= 32) were classified as frail. For women with (BMI <= 23 and a grip strength of <= 17) or (BMI 23.1-26 and a GS <= 17.3) or (BMI 26.1-29 and a GS <= 18) or (BMI > 29 and a GS <= 21) were classified as frail.The outcome is the number of participants who were classified as “frail” at baseline and changed to “not frail” at 6 months."|baseline; 6 months|One subject in the active drug oral salsalate group and 2 in the placebo arm group were missing outcome measure.||participants|||Number
685301|NCT01505387|Secondary|Waist and Hip Circumference (cm)|Changes from baseline to end of study|24 weeks||||||
685226|NCT01506726|Secondary|Change in the Frailty Component as Determined by Self-reported Activity Level|To quantify the impact of anemia treatment by salsalate on change in the frailty as measured by change in self-reported activity level. Frailty for activity level is classified by subjects responses to 6physical activity questions on the short version of the Minnesota Leisure Time Activity Questionnaire , were related to walking for exercise, moderately strenuous outdoor chores, dancing, bowling, and regular exercise. The Women's Health And Aging Study (WHAS) scoring algorithm was used to define frailty for self-reported activity level. The answers to these questions were used to calculate kilocalories (Kcals) per week, using the WHAS algorithm, which is further satisfied by by gender. For men, Kcals < 128 per week is frail. For women, Kcals < 90 per week is frail. This is a categorical measurement of yes or no. The outcome is the number of participants who were classified as “frail” at baseline and changed to “not frail” at 6 months.|baseline; 6 months|One subject in the active drug oral salsalate group and 2 in the placebo arm group were missing outcome measure.||participants|||Number
685227|NCT01506726|Secondary|Change in Self Reported Outcomes Measures as Reported by FACIT-AN Total Score|To quantify the impact of anemia treatment by salsalate on self -reported outcomes measures by subjects answering 47 questions for patients with anemia and or fatigue. This test detects self-report functional changes and QoL. Change from baseline to 6 months. Scores range from 0-188 with higher scores indicating better function.|baseline; 6 months|One subject in the active drug oral salsalate group and 2 in the placebo arm group were missing outcome measure.||scores on a scale||Standard Deviation|Mean
685228|NCT01506726|Secondary|Change in Self Reported Outcomes Measures as Reported by Short Form-36 (SF-36) Physical Component Score (PCS)|To quantify the impact of anemia treatment by salsalate on self-reported outcomes measures by change in SF36 physical component score. The SF-36 form identifies self-report physical function and global measure of quality of life and is a multi-purpose, short-form health survey consisting of 36 questions. The Physical Component Summary (PCS) is a subscale of the SF-36 that correlates with physical health domains of the SF-36 ( Physical Function, Role-Physical, and Bodily Pain). The change is calculated and compared from baseline to 6 months. The SF-36 PCS score is a norm based sore with a mean of 50 and standard deviation of 10 where results above and below 50 are above and below the average, respectively, in the 2009 general US population.|baseline; 6 months|One subject in the active drug oral salsalate group and 2 in the placebo arm group were missing outcome measure.||t score||Standard Deviation|Mean
685229|NCT01506726|Secondary|Change in Cognitive Outcome Measures as Determined by Composite Learning and Memory|To quantify the impact of anemia treatment by salsalate on cognitive outcomes based on Learning and memory was derived using the z-scores of the following three tests: (1) CogState ISL immediate recall score (total score from three learning trials), (2) CogState ISL immediate recall score from the first learning trial, and (3) CogState ISL delayed recall scores. The composite score for a subject at each time point was defined as the mean of the Z-scores for the three tests at the time point. For each subject, the Z-score for each test at time point was derived by subtracting the overall baseline mean of the test from the subject's score at the time point and then dividing by the overall baseline standard deviation of the test. Positive z-scores indicate a better performance compared to the baseline average. The change in the Z-score from baseline to month 6.|baseline; 6 months|One subject in the active drug oral salsalate group and 3 in the placebo arm group were missing outcome measure.||change in Z-Score||Standard Deviation|Mean
685230|NCT01506726|Secondary|Change in Cognitive Outcome Measures as Determined by Composite Complex Attention/Executive Processing|To quantify the impact of anemia treatment by salsalate on cognitive outcomes based on Complex attention/executive processing was derived using the z-scores of the following three tests: (1) TMT Part B seconds per completed circle, (2) time score from the CogState One Back Task, and (3) accuracy score from the CogState One Back Task. The composite score for a subject at each time point was defined as the mean of the Z-scores for the three tests at the time point. For each subject, the Z-score for each test at time point was derived by subtracting the overall baseline mean of the test from the subject's score at the time point (accuracy score) or by subtracting the subject's score at the time point from the overall baseline mean of the test (TMT and time score) and then dividing by the overall baseline standard deviation of the test. Positive z-scores indicate a better performance compared to the baseline average. The change in the Z-score from baseline to month 6.|baseline; 6 months|One subject in the active drug oral salsalate group and 3 in the placebo arm group were missing outcome measure.||change in Z-Score||Standard Deviation|Mean
685231|NCT01506726|Secondary|Change in Cognitive Outcome Measures as Determined by Speed of Processing|To quantify the impact of anemia treatment by salsalate on cognitive outcomes based on speed of processing was derived using the z-scores of the following three tests: (1) TMT Part A seconds per completed circle, (2) simple reaction time from the CogState Detection Task, and (3) choice reaction time from the CogState Identification Task. The composite score for a subject at each time point was defined as the mean of the Z-scores for the three tests at the time point. For each subject, the Z-score for each test at time point was derived by subtracting the subject's score at the time point from the overall baseline mean of the test and then dividing by the overall baseline standard deviation of the test. Positive z-scores indicate a better performance compared to the baseline average.The change in the Z-score from baseline to month 6.|baseline; 6 months|One subject in the active drug oral salsalate group and 3 in the placebo arm group were missing outcome measure.||change in Z-Score||Standard Deviation|Mean
685232|NCT01506726|Secondary|Change in Frailty Component Related to Fatigue/ Exhaustion|"Subjective fatigue/exhaustion: If any of the following three criteria are met, the patient will be classified as frail for fatigue/exhaustion:
“In the past month, on average, have you been feeling unusually tired during the day?” is answered “yes” and indicated as “all of the time” or “most of the time.”
“In the past month, on average, have you felt unusually weak?” is answered “yes” and indicated as “all of the time” or “most of the time.”
Energy level on a scale of 0 (no energy) to 10 (most energy) reported as ≤ 3. If the subject answers YES to any of the above noted 3 questions, then they are classified as FRAIL.
The change in frailty for fatigue/ exhaustion is defined as changing from frail at baseline to not frail at month 6 as reported by the subject."|baseline; 6 months|One subject in the active drug oral salsalate group and 2 in the placebo arm group were missing outcome measure.||participants|||Number
685302|NCT01505387|Primary|Mean Change in Body Weight From Baseline to End of 24 Weeks|Change in body weight at the end of 24 weeks measured in kg using a calibrated scale. (positive values signify weight gain, while negative values signify weight reduction|24 weeks|||kg||Standard Deviation|Mean
685234|NCT01506726|Secondary|Change in Serum Hepcidin Levels|To compare the change in serum hepcidin levels between treatment groups and whether such a change is proportional to the decline in IL-6 levels. Change in the hepcidin from prior to study drug to 6 months. Positive changes represent increases in hepcidin levels and negative changes represent decreases.|prior to study drug; 6 months|One subject in the active drug oral salsalate arm and 3 subjects in the placebo arm are missing outcome measures.||ng/ml||Standard Deviation|Mean
685235|NCT01506726|Secondary|Assessment of Serum Biomarkers of Erthropoiesis|To assess whether oral salsalate improves serum biomarkers of erythropoiesis by increasing erythropoietin (Epo) in UAE subjects. Change in the Epo from prior to study drug to 6 months.|prior to study drug; 6 months|One subject in the active drug oral salsalate arm and two subjects in the placebo arm are missing outcome measures.||mIU/ml||Standard Deviation|Mean
685236|NCT01506726|Secondary|Change in Markers of Inflammation|To assess whether oral salsalate reduces markers of inflammation including IL-6 and Tumor Necrosis Factor Receptor1 (TNF-R1) in UAE subjects. Change in the marker from prior to study drug to 6 months.|prior to study drug; 6 months|One subject in the active drug oral salsalate group and two subjects in the placebo arm group were missing outcome measures.||pg/ml||Standard Deviation|Mean
685237|NCT01506726|Other Pre-specified|Association Between Change in Hemoglobin and Change in Markers of Inflammation.|To examine whether there is an association between change in hemoglobin and changes in markers of inflammation from prior to study drug to 6 months. Inflammatory markers to be measured are iL-6, Tumor Necrosis Factor alpha Receptor1 (TNF-R1), and C-reactive protein (CRP) in anemia subjects.Correlation between change in the inflammatory markers and the change in HB from prior to study drug to 6 months.|prior to study drug; 6 months|One subject from the active drug oral salsalate group and 2 subjects from the placebo arm group are missing outcomes.||correlation coefficient|||Number
685238|NCT01506726|Other Pre-specified|Change in the 6 Minute Walk Test (6MWT) Distance.|To assess the impact of treatment of anemia with oral salsalate will improve 6 minute walk test (6MWT) distance from baseline to 6 months as measured in meters and centimeters.|baseline; 6 months|Two subjects were missing outcome measure in both the active drug and the placebo arm.||meters||Standard Deviation|Mean
685239|NCT01506726|Primary|Change in Hemoglobin Level From Baseline to 6 Month Visit|To test whether the administration of oral salsalate to a subset of elderly subjects with unexplained anemia (UAE) and high interleukin (IL-6) levels will improve hemoglobin level|baseline; 6 months|||g/dL||Standard Deviation|Mean
685240|NCT01506596|Secondary|Overall Survival (OS)|OS was measured from date of consent until time of death from any cause, up to 32 months.|Date of Consent until death, up to 32 months|||months||95% Confidence Interval|Median
685241|NCT01506596|Secondary|Duration of Response|Response is defined as Complete Response (CR) or Partial Response (PR) per RECIST v1.1. Repeat radiologic imaging will be conducted after every 3 cycles of treatment (approximately every 12 weeks) to evaluate disease status per RECIST v1.1. Confirmation of CR or PR is required by repeat scans that should be performed 4 weeks after the criteria for response are first met.|Measure of the amount of time that the criteria for response per RECIST are first met until disease progression|Since so few patients experienced a response, the pre-specified endpoint of duration of response was not analyzed.|||||
685242|NCT01506596|Secondary|Best Overall Response|Best overall response is defined as the best response across all time points. Repeat radiologic imaging was conducted after every 3 cycles of treatment (approximately every 12 weeks). Response was evaluated using RECIST v1.1 guidelines, where complete response (CR) is the disappearance of all target and non-target lesions; partial response (PR) is >=30% decrease in the sum of diameters of target lesions; progressive disease (PD) is >=20% increase in the sum of diameters of target lesions, or a measurable increase in a non-target lesion, or the appearance of >=1 new lesion; stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|Date of consent until end of study treatment, up to 32 months|||percentage of participants|||Number
685243|NCT01506596|Secondary|Progression Free Survival (PFS)|PFS was measured from date of consent until the subject experiences disease progression (assessed approximately every 12 weeks) or death, whichever came first, up to 27 months. Repeat radiologic imaging will be conducted after every 3 cycles of treatment (approximately every 12 weeks) to evaluate disease status per RECIST v1.1. Subjects who discontinue study treatment for reasons other than disease progression will continue to have their disease status reported every 3 months post end of treatment up to 27 months.|Date of Consent until progression or death, up to 27 months|||months||95% Confidence Interval|Median
685244|NCT01506596|Primary|12-week Progression Free Rate|Progression will be as defined per Response Evaluation Criteria In Solid Tumors (RECIST) guidelines version 1.1. Subjects who remain under observation and progression free at 12 weeks will be defined as treatment successes. Subjects who progress per RECIST by 12 weeks or who drop out without evidence of progression prior to 12 weeks will be defined as treatment failures.Progression is defined using Response Evaluation Criteria in Solid Tumors (RECIST v1.1), as a >=20% increase in the sum of diameters of target lesions, or a measurable increase in a non-target lesion, or the appearance of >=1 new lesion.|Assessed after 12 weeks of study treatment|||percentage of participants||95% Confidence Interval|Number
685245|NCT01506362|Secondary|Proportion of Patients With Mucosal Healing After Completion of Study Treatment Defined as Reduction in Endoscopy Subscore of ≥ 1 From Baseline & an Absolute Endoscopy Subscore of ≤ 1 Assessed by Flexible Sigmoidoscopy.||5 weeks following first administration||||||
685246|NCT01506362|Primary|Proportion of Patients Who After Study Completion Achieve Clinical Response Defined by at Least a 3point Decrease & 30% Reduction From Baseline in Mayo Score Plus ≥ 1 Point Decrease in Rectal Bleeding Sub-score or Absolute Rectal Bleeding Subscore of ≤ 1|"Mayo score assesses stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment. It is assessed according to the following parameters:
Stool frequency (subscore 0-3) 0: Normal number of stools for patient
1 to 2 stools per day more than normal
3 to 4 stools more than normal
> or = to 5 stools more than normal
Rectal bleeding (subscore 0-3) 0: No blood seen
Streaks of blood with stool less than half the time
Obvious blood with stool most of the time
Blood alone passes
Endoscopic findings (subscore 0-3) 0: Normal or inactive disease
1 Mild Disease (erythema, decreased vascular pattern, mild friability) 2: Moderate Disease (marked erythema, lack of vascular pattern, friability erosions) 3: Severe Disease (spontaneous bleeding, ulceration)
Physician's Global Assessment (subscore 0-3) 0: Normal
Mild disease
Moderate disease
Severe disease"|From Baseline to day 34 (end of treatment period)|||participants|||Number
685247|NCT01506323|Secondary|Five Facet Mindfulness Questionnaire (FFMQ)|FFMQ a 39-item scale that measures five components of mindfulness: observing; describing; acting with awareness; non-judging of inner experience; and non-reactivity to inner experience. Each subscale contains either 7 or 8 items that are rated on a 1 (never or very rarely true) to 5 (very often or always true) Likert scale. Items are randomly reversed scored and higher scores represent greater levels of mindfulness. Total scores range from 39 to 195.|Baseline to post-treatment (week 8); baseline to 2-months follow-up.|Intent to treat analysis included 89 MRP and 84 PCT participants. Completers at post-treatment included 70 MRP and 72 PCT participants. Completers at 2-months follow up included 65 MRP and 71 PCT participants.||units on a scale||Standard Deviation|Mean
685248|NCT01506323|Secondary|Functional Assessment of Chronic Illness Therapy-Spiritual Wellbeing Scale-Expanded (FACIT-SpEx)|The FACIT-SpEx was developed to assess spiritual components (e.g., harmony, meaning, purpose in life, peacefulness, faith/assurance) of quality of life using 23 items rated on a 5-point Likert scale from 0 (not at all) to 4 (very much). Total scores range from 0 to 92. Higher scores indicating greater spiritual well-being. Validity has been demonstrated by significant Pearson correlations between measures of quality of life, mood, and religious growth. It has demonstrated internal consistency reliability.|Baseline to post-treatment (week 8); baseline to 2-months post-treatment.|Intent to treat analysis included 89 MRP and 84 PCT participants. Completers at post-treatment included 70 MRP and 72 PCT participants. Completers at 2-months follow up included 65 MRP and 71 PCT participants.||units on a scale||Standard Deviation|Mean
685249|NCT01506323|Secondary|Spielberger Trait Anger Inventory-Short Form|Spielberger Trait Anger Inventory-Short Form is a 10-item questionnaire with 4-point Likert scale used to measure anger as a personality trait. Scores range from 10 to 40 with higher scores indicating more trait anger. Concurrent validity has been supported by correlations with measures of hostility, neuroticism, and anxiety. Internal consistency reliability has been reported as good to excellent.|Baseline to post-treatment (week 8); baseline to 2-months post-treatment.|Intent to treat analysis included 89 MRP and 84 PCT participants. Completers at post-treatment included 70 MRP and 72 PCT participants. Completers at 2-months follow up included 65 MRP and 71 PCT participants.||units on a scale||Standard Deviation|Mean
685250|NCT01506323|Primary|PTSD Checklist-Military Version [Diagnostic and Statistical Manual (DSM) IV-TR Version]|PCL-M: PTSD Checklist-Military version (PCL-M) is a 17-item self-report screening instrument for PTSD symptoms related to military trauma. Items are scored on a 1 (not at all bothersome) to 5 (extremely bothersome) Likert scale. Total scores range from 17 to 85. Higher scores indicate greater symptom bothersomeness. A score of > 50 can suggest PTSD Test-retest reliability is high (r = 0.96) and validity is adequate, with a Kappa of 0.64 agreement for PTSD diagnosis compared to the Structured Clinical Interview for DSM-IV.|Baseline to post-treatment (week 8); Baseline to 2-months post-treatment.|Intent to treat analysis included 89 MRP and 84 PCT participants. Completers at post-treatment included 70 MRP and 72 PCT participants. Completers at 2-months follow up included 65 MRP and 71 PCT participants.||units on a scale||Standard Deviation|Mean
685251|NCT01506323|Secondary|Spielberger State Anger Inventory-Short Form|Spielberger State Anger Inventory-Short Form is a 10-item questionnaire with 4-point Likert scale to measure anger as an emotional state. Scores range from 10 to 40 with higher scores indicating more anger. Concurrent validity has been supported by correlations with measures of hostility, neuroticism, and anxiety. Internal consistency reliability has been reported as good to excellent.|Baseline to post-treatment (week 8); baseline to 2-months post-treatment.|Intent to treat analysis included 89 MRP and 84 PCT participants. Completers at post-treatment included 70 MRP and 72 PCT participants. Completers at 2-months follow up included 65 MRP and 71 PCT participants.||units on a scale||Standard Deviation|Mean
685252|NCT01506323|Secondary|Patient Health Questionnaire (PHQ-9) for Depression|PHQ-9 is a 9-item depression screening tool based on the diagnostic criteria for major depressive disorder in the DSM-IV. Each item is rated from a 0 (not at all) to 3 (nearly every day) scale. Items are summed and total scores range from 0 to 27. Higher scores indicate worse depression. A score of 11 or more considered probable depression and 20 or more is considered severe depression. It is well-validated and widely-used in medical settings such as primary care. The PHQ-9 includes the two major symptom domains characteristic of depression: affective and somatic symptoms.|Baseline to post-treatment (week 8); Baseline to 2-months post-treatment.|Intent to treat analysis included 89 MRP and 84 PCT participants. Completers at post-treatment included 70 MRP and 72 PCT participants. Completers at 2-months follow up included 65 MRP and 71 PCT participants.||units on a scale||Standard Deviation|Mean
685253|NCT01506323|Secondary|Insomnia Severity Index (ISI)|ISI is a widely used measure of insomnia with well-established reliability and validity. It consists of seven items, three of which assess severity of insomnia (i.e., degree of difficulty falling asleep, staying asleep, and waking too early). The remaining questions tap satisfaction with sleep pattern, effect of sleep on daytime and social functioning, and concern about current sleep difficulties. Both categorical and continuous measures of sleep difficulties can be assessed. Items are rated on a 0-4 Likert scale with higher scores meaning greater insomnia. Total scores range from 0-28. Original results were interpreted as 0-7 = no clinically significant insomnia, 8-14 = sub-threshold insomnia, 15-21 = moderately severe clinical insomnia and 21-28 = severe clinical insomnia. Later recommendations for a clinical, not community sample, are a cut-off of 11 points.|Baseline to post-treatment (week 8); baseline to 2 months post-treatment.|Intent to treat analysis included 89 MRP and 84 PCT participants. Completers at post-treatment included 70 MRP and 72 PCT participants. Completers at 2-months follow up included 65 MRP and 71 PCT participants.||units on a scale||Standard Deviation|Mean
685254|NCT01506323|Primary|Hyperarousal (Criterion D) on the Clinician Administered PTSD Scale (CAPS)|This subscale measures the frequency and intensity of increased arousal as indicated by two or more of the following: (1) difficulty falling or staying asleep, (2) irritability or outbursts of anger, (3) difficulty concentrating, (4) hypervigilance, and/or (5) exaggerated startle response. Duration of these symptoms is greater than one month and causes clinically significant distress or impairment in social, occupational, or other important areas of of functioning. Scores range from 0 to 40. Higher scores indicate greater severity of symptoms.|Baseline to post-treatment (week 8); baseline to 2 months post-treatment.|Intent to treat analysis included 89 MRP and 84 PCT participants. Completers at post-treatment included 69 MRP and 72 PCT participants. Completers at 2-months follow up included 65 MRP and 71 PCT participants.||units on a scale||Standard Deviation|Mean
685303|NCT01505374|Secondary|Postoperative Complications||Up to postoperative day 2|Analysis of postoperative complications was not performed because sufficient data could not be collected regarding the secondary outcome|||||
685255|NCT01506323|Primary|Avoidance Subscale (Criterion C) on the Clinician Administered PTSD Scale (CAPS)|This subscale measures the frequency and intensity of persistent avoidance of stimuli associated with the trauma and numbing of general responsiveness as indicated by 3 or more of the following: (1) efforts to avoid thoughts, feelings, or conversations associated with the trauma, (2) efforts to avoid activities, places or people that arouse recollections of the trauma, (3) inability to recall an important aspect of the trauma, (4) markedly diminished interest or participation in significant activities, (5) feelings of detachment or estrangement from others, (6) restricted range of affect, and/or (7) sense of a foreshortened future. Duration of these symptoms is greater than one month and causes clinically significant distress or impairment in social, occupational, or other important areas of of functioning. Scores range from 0 to 56 with higher scores indicating greater severity of avoidance.|Baseline to post-treatment (week 8); Baseline to 2 months post-treatment.|Intent to treat analysis included 89 MRP and 84 PCT participants. Completers at post-treatment included 69 MRP and 72 PCT participants. Completers at 2-months follow up included 65 MRP and 71 PCT participants.||units on a scale||Standard Deviation|Mean
685256|NCT01506323|Primary|Re-experiencing Subscale (Criterion B) on the Clinician Administered PTSD Scale (CAPS)|This subscale measures the frequency and intensity of (1) recurrent or intrusive recollections of trauma, (2) recurrent, distressing dreams of the trauma, (3) acting as if the traumatic event were recurring like a flashback, (4) intense psychological distress at exposure to internal or external cues that resemble the trauma; and/or (5) physiological reactivity on exposure to internal or external cues that symbolize or resemble an aspect of the trauma. Duration of these symptoms is greater than one month and symptoms cause clinically significant distress or impairment in social, occupational, or other important areas of of functioning. Scores can range from 0 to 40 and higher scores mean greater severity of re-experiencing.|Baseline to post-treatment (week 8); Baseline to 2 months post-treatment.|Intent to treat analysis included 89 MRP and 84 PCT participants. Completers at post-treatment included 69 MRP and 72 PCT participants. Completers at 2-months follow up included 65 MRP and 71 PCT participants.||units on a scale||Standard Deviation|Mean
685257|NCT01506323|Primary|Clinician-Administered PTSD Scale (CAPS) Diagnostic and Statistical Manual, 4th ed., Text Revision (DSM-IV)|PTSD symptom severity is measured by CAPS to determine PTSD diagnosis. The scale rates 17 items representing the Diagnostic and Statistical Manual IV (DSM-IV) criteria B (re-experiencing), C (avoidance/numbing) and D (hyper-arousal). CAPS has demonstrated high levels of internal consistency, good inter-rater reliability, & excellent convergent validity. The F1/I2 rule will be applied to establish the diagnosis of PTSD aligned with DSM-IV (e.g. one symptom of Criterion B, three of Criterion C, and two of Criterion D. The CAPS also includes an item to assess duration of PTSD symptoms. CAPS total score ranges from 0-136 with higher scores indicating greater symptom severity.|Baseline to post-treatment (week 8); Baseline to 2 months post-treatment.|Intent to treat analysis included 89 MRP and 84 PCT participants. Completers at post-treatment included 69 MRP and 72 PCT participants. Completers at 2-months follow up included 65 MRP and 71 PCT participants.||units on a scale||Standard Deviation|Mean
685258|NCT01506193|Secondary|Antibody Titers Against Measles, Mumps, Rubella and Varicella Viruses|Antibody titers were summarized by geometric mean concentrations (GMCs) with their 95% confidence intervals (CIs) for the following cut-offs: ≥ 150 mIU/mL, ≥ 231 U/mL, ≥ 4 IU/mL and ≥ 25 mIU/mL for anti-measles, anti-mumps, anti-rubella and anti-varicella, respectively.|At Day 42 after vaccination|The analysis was performed on the ATP cohort for immunogenicity post-dose 1 which included all eligible subjects with post-dose 1 serology results available for at least one antigen, who received medication/vaccine and who had no underlying medical condition forbidden in the protocol before the Visit 2 last blood drawn.||Titers||95% Confidence Interval|Geometric Mean
685259|NCT01506193|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Throughout study period (from Day 0 to approximately Month 4)|The analysis was performed on the Total Vaccinated cohort which included all subjects with study vaccine administered.||Subjects|||Number
685260|NCT01506193|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within 43 days (Days 0-42) after each vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with study vaccine administered.||Subjects|||Number
685261|NCT01506193|Secondary|Number of Subjects Reporting Any, Localised and Generalised Rashes|Rash/exanthem was defined as: 1) measles/ rubella rashes (macular or maculo-papular rashes): presence of macules, discolored small patches or spots of the skin, neither elevated nor depressed below the skin’s surface. 2) varicella rash (maculo-papulo-vesicular): simultaneous presence of macules, papules and vesicles raised above the skin’s surface or other types of rash (heat rash, diaper rash etc.). Any rash = no lesions and grade 3 = > 150 lesions.|Within the 43-day (Days 0-42) post-vaccination period|The analysis was performed on the Total Vaccinated cohort which included all subjects with study vaccine administered, on subjects with their symptom sheets for rash completed.||Subjects|||Number
685262|NCT01506193|Secondary|Number of Subjects Reporting Fever Per Half Degree|Any fever = fever ≥ 38.0°C on rectal setting, grade 3 fever = fever > 39.5 °C and related = fever assessed by the investigator as causally related to study vaccination.|During the 43-day (Days 0-42) post-vaccination period|The analysis was performed on the Total Vaccinated cohort which included all subjects with study vaccine administered, on subjects with their symptom sheets completed.||Subjects|||Number
685263|NCT01506193|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were Parotid / salivary gland swelling and suspected signs of meningism / febrile convulsions. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 parotid / salivary gland swelling = swelling with accompanying general symptoms and Related = symptom assessed by the investigator as related to the vaccination.|During the 43-day (Days 0-42) post-vaccination period|The analysis was performed on the Total Vaccinated cohort which included all subjects with study vaccine administered, on subjects with their symptom sheets completed.||Subjects|||Number
685264|NCT01506193|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, irritability/fussiness and loss of appetite. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activity. Related = symptom assessed by the investigator as related to the vaccination.|During the 15-day (Days 0-14) post-vaccination period|The analysis was performed on the Total Vaccinated cohort which included all subjects with study vaccine administered, on subjects with their symptom sheets completed.||Subjects|||Number
685265|NCT01506193|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = Cried when limb is moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site. This outcome measure concerns subjects in Priorix-Tetra + Meningitec Group and Priorix-Tetra Group only. Subjects in Priorix-Tetra Group did not receive Meningitec® vaccine.|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated cohort which included all subjects with study vaccine administered, on subjects with their symptom sheets completed.||Subjects|||Number
685266|NCT01506193|Primary|Number of Seroprotected Subjects for rSBA-MenC Antibodies|Seroprotection was defined as the appearance of rSBA-MenC antibody titer ≥ 1:8.|At 42 days after vaccination|The analysis was performed on all eligible subjects with post-dose 1 serology results available for at least one antigen in this analysis, included in the ATP cohort for immunogenicity post-dose 1, who received medication/vaccine and who had no underlying medical condition forbidden in the protocol before the Visit 2 last blood draw.||Subjects|||Number
685267|NCT01506193|Primary|Number of Seroconverted Subjects for Measles, Mumps, Rubella, and Varicella Virus|Seroconversion was defined as the appearance of antibodies (i.e. concentration/titer ≥ the cut-off value) in the serum of subjects seronegative before vaccination. The cut-off values for serocoversion were 150 mIU/mL, 231 U/mL, 4 IU/mL and 25 mIU/mL for measles, mumps, rubella and varicella, respectively.|At 42 days after vaccination|The analysis was performed on all eligible subjects with post-dose 1 serology results available for at least one antigen in this analysis, included in the ATP cohort for immunogenicity post-dose 1, who received medication/vaccine and who had no underlying medical condition forbidden in the protocol before the Visit 2 last blood draw.||Subjects|||Number
685268|NCT01505881|Secondary|Percentage of Deaths, Venous Thromboembolism (VTE), Myocardial Infarction (MI), Transient Ischaemic Attacks (TIA), Strokes, Systemic Embolism, and Valve Thrombosis.|"Clinical efficacy outcome events presented are:
Death, Venous thromboembolism (VTE), Myocardial Infarction (MI), Transient Ischaemic Attack (TIA), Stroke, Systemic embolism and Valve thrombosis"|From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)|Treated set (TRT): The TRT comprised all patients who were documented to have taken at least 1 dose of study drug||percentage of participants|||Number
685269|NCT01505881|Secondary|Percentage of Patients With Serious AEs|Percentage of patients with Serious Adverse Events (SAE). Prespecified clinical outcome events were not recorded as Adverse Events.|From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)|Treated set (TRT): The TRT comprised all patients who were documented to have taken at least 1 dose of study drug||percentage of participants|||Number
685270|NCT01505881|Secondary|Percentage of Patients With AEs Leading to Discontinuation of Trial Drug|"Percentage of patients with Adverse Events leading to discontinuation of trial drug.
Prespecified clinical outcome events were not recorded as Adverse Events."|From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)|Treated set (TRT): The TRT comprised all patients who were documented to have taken at least 1 dose of study drug||percentage of participants|||Number
685271|NCT01505881|Primary|Percentage of Patients With Any Adverse Event (AE)|Percentage of patients with Adverse Events. Prespecified clinical outcome events were not recorded as Adverse Events.|From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)|Treated set (TRT): The TRT comprised all patients who were documented to have taken at least 1 dose of study drug||percentage of participants|||Number
685272|NCT01505764|Secondary|Safety and Tolerability.|The safety and tolerability of Anamorelin HCl assessed through the number of participants with Adverse Events.|2 years||||||
685273|NCT01505764|Secondary|Body Composition.|Body composition as measured by Total body nitrogen and bioimpedance.|2 years||||||
685274|NCT01505764|Secondary|Functional Performance.|Functional performance using stair-climbing power, 6-minute walk, tests of the major muscle groups and 24 hour physical activity levels|2 years||||||
685275|NCT01505764|Secondary|Resting Energy Expenditure.||2 years||||||
685276|NCT01505764|Secondary|Appetite.|Appetite measured by a visual analogue scale and a food diary.|2 years||||||
685277|NCT01505764|Secondary|Quality of Life.|Quality of life as assessed using the Assessment SpondyloArthritis (ASAS), EuroQol five dimensions questionnaire (EQ-5D) and FACIT-F, Patient Reported Outcome assessments|2 years||||||
685278|NCT01505764|Secondary|Body Weight.||2 years||||||
685279|NCT01505764|Secondary|Muscle Strength as Measured by Grip Strength.||2 years||||||
685280|NCT01505764|Secondary|Body Composition as Measured by Densitometry.||2 years||||||
685281|NCT01505764|Primary|Total Body Potassium.||2 years|10 subjects were consented, 9 received drug or placebo, primary outcome measure is available for 6 subjects, 5 completed the study.||percentage change from baseline||Full Range|Median
685282|NCT01505647|Secondary|Number of Participants With One or More Serious Adverse Experience Day 1 to 182 Postvaccination|"An SAE is defined as any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an other important medical event based on medical judgement"|Day 1 to Day 182 postvaccination|Analysis included all vaccinated participants with safety follow-up data. One participant in the AMP vaccine group was vaccinated but lost to follow-up without safety follow-up.||Participants|||Number
685304|NCT01505374|Secondary|Rating the Success of the Nerve Blocks||Up to postoperative day 2|The success of nerve blocks was not collected or analyzed. Instead, muscle strength was collected (data are presented in another table).|||||
685305|NCT01505374|Secondary|Duration of Motor and Sensory Blockade||Up to postoperative day 2|The duration of motor and sensory blockade was not calculated and analyzed, because accurate data regarding block resolution time could not be acquired from patients.|||||
685283|NCT01505647|Secondary|Number of Participants With One or More Serious Adverse Experience (SAE) Day 1 to 42 Postvaccination|"An SAE is defined as any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an other important medical event based on medical judgement"|Day 1 to Day 42 postvaccination|Analysis included all vaccinated participants with safety follow-up data. One participant in the AMP vaccine group was vaccinated but lost to follow-up without safety follow-up.||Participants|||Number
685284|NCT01505647|Secondary|Number of Participants With One or More Adverse Experiences (AEs)|"An AE is defined as any unfavorable and unintended change in the
structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse experience."|Day 1 to Day 42 postvaccination|Analysis included all vaccinated participants with safety follow-up data. One participant in the AMP vaccine group was vaccinated but lost to follow-up without safety follow-up.||Participants|||Number
685285|NCT01505647|Primary|Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers|VZV antibody titers were determined by gpELISA. The GMFR reports the geometric mean of the ratio of individual participant VZV antibody titers at Week 6 / Day 1 (Baseline).|Day 1 (Baseline) to Week 6 postvaccination|Analysis included all vaccinated participants except those who had protocol deviations that interfered with the assessment of antibody response, developed suspected varicella or herpes zoster rashes before blood sampling, or reported an exposure to varicella or herpes zoster.||Ratio||95% Confidence Interval|Geometric Mean
685286|NCT01505647|Primary|Geometric Mean Titer (GMT) of Varicella-Zoster Virus (VZV) Antibody|VZV antibody titers were determined by glycoprotein enzyme-linked immunosorbent assay (gpELISA)|Day 1 and Week 6 postvaccination|Analysis included all vaccinated participants except those who had protocol deviations that interfered with the assessment of antibody response, developed suspected varicella or herpes zoster rashes before blood sampling, or reported an exposure to varicella or herpes zoster||Units/mL||95% Confidence Interval|Geometric Mean
685287|NCT01505608|Secondary|Median Overall Survival (OS) of Participants|To determine OS and clinical benefit (CR/PR/SD) in this population|3 years|Not evaluated due to early closure. Study data does not exist.|||||
685288|NCT01505608|Secondary|Progression Free Survival (PFS) of Participants Using Days Until Progression|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|3 years|Arm A- 2 subjects randomized to TMZ+I. Arm B- 6 evalubale patients in Phase 1 + 4 evaluable patients in Phase 2- all received TMZ+I+TPI||Days|||Number
685289|NCT01505608|Secondary|Measure Quality of Life of Children Receiving TPI287 Using PedsQL Questionnaires|Evaluate the impact on QOL of children receiving TPI+I+TMZ|3 years|QOL's not collected due to early closure of study. Data not collected or analyzed threfore no data exists.|||||
685290|NCT01505608|Secondary|Pharmacokinetics (PK) of TPI 287 in the Phase I Population of This Trial.|To evaluate the drug levels and pharmacokinetics (PK) of TPI 287 from blood samples at multiple time points within the first 24 hours on study.|1 year|PK's not run due to early closure of study. Data not collected or analyzed threfore no data exists.|||||
685291|NCT01505608|Primary|Overall Response Rate (ORR) of Participants Using RECIST Criteria|"Phase I portion of trial- All patients enrolled to recieve TPI+I+TMZ. These patients will be added to the Phase II patients that were randomized to Arm B- Arm with TPI 287 (recieved same tx as Phase I participatns).
Phase II portion of trial- TPatients enrolled to this portion (different patients than enrolled to Phase 1) were randomized to Arm A: I+TMZ OR Arm B: TPI+I+TMZ Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|3 years|"8 enrolled to Phase 1: two were non-evaluable =6 move to analysis. Another 4 randomized to Arm B with TPI 287 in Phase 2=10 evaluable in TPI 287 analysis.
2 subjects were enrolled in the Phase 2 randomized portion of the trial to Arm A- without TPI 287. This makes 2 evaluable subjects in this analysis population (did not receive TPI 287)."||participants|||Number
685292|NCT01505608|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|"To determine the safety and tolerability of TPI 287 in combination with Irinotecan and Temozolomide (TPI+I+TMZ) in pediatric and young adult patients with primary refractory or recurrent Neuroblastoma.
Phase I patients were all enrolled to receive TPI 287. Phase 2 is where randomization began. Patients were different patients than the Phase 1 patients. Below all patients that received TPI 287 are included in the TPI 287 group. This includes Phase I patients and the Phase 2 patients randomized to TPI 287."|6 months|This group includes the 8 patients enrolled to phase 1 TPI 287 portion of the study plus the 4 additional patients randomized to TPI 287 in the Phase 2 portion = 12 patients total that received TPI 287 on this study.||participants|||Number
685293|NCT01505465|Secondary|Melatonin Effects on Patient Controlled Analgesia and Postoperative Narcotic Usage|A 25% in narcotic usage will be considered clinically important|Up to 3 days|DATA NOT COLLECTED|||||
685294|NCT01505465|Secondary|Melatonin Effects on Daytime Activity|A 20% difference will be considered clinically important.|Up to postoperative day 3|DATA NOT COLLECTED|||||
685295|NCT01505465|Secondary|Melatonin Effects on Delirium During Post-operative Inpatient Stay Based on Clinical Assessment in Patients 65 and Older|A difference of 25% will be considered clinically important.|Up to postoperative day 3|DATA NOT COLLECTED|||||
685296|NCT01505465|Secondary|Perioperative Effects of Melatonin on Post-operative Pain Scores|A difference in 25% in average pain score at each time point be considered clinically significant.|Up to postoperative day 3|DATA NOT COLLECTED|||||
685297|NCT01505465|Primary|Perioperative Sleep Efficiency|Sleep time change from 96 hours before surgery to 72 hours after surgery|96 hours before surgery to 72 hours after surgery|||minutes||Inter-Quartile Range|Mean
685298|NCT01505387|Secondary|Blood Pressure|Measured in mm Hg|24 weeks||||||
685299|NCT01505387|Secondary|Full Blood Count|Erythrocytes, leukocytes, thrombocytes, haematocrit, haemoglobin, Mean corpuscular volume (MCV), Mean corpuscular haemaglobin (MCH)|24 weeks||||||
685300|NCT01505387|Secondary|Body Mass Index (kg/m^2)|Changes from baseline to end of study|24 weeks||||||
685320|NCT01504958|Secondary|Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL)|23 item scale to assess activities of daily living. Scores range from 0 to 78 with a higher score indicating less functional impairment. The scores reported below are the means of the actual scores from the assessments representing the percent change from baseline.|Pre-treatment, 1 month Post-treatment|||percent change||Standard Deviation|Mean
685321|NCT01504958|Secondary|Clinical Global Impression of Change (CGIC)|The CGI is a three-item scale used to assess treatment response in psychiatric patients. The CGI-C subset measures the global improvement or change from baseline. Scores range from 0 to 7, with 0 indicating marked improvement and 7 indicating marked worsening. The scores below represent the percent change of the scores from baseline.|Pre-treatment, 1 month post treatment|||percent change||Standard Deviation|Mean
685322|NCT01504958|Primary|Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)|Assessment to measure the severity of all of the most important symptoms of Alzheimer's disease: loss of memory, language, praxis, and attention. The total scoring range is 0-70, with 0 representing the least impairment and 70 the most severe impairment. The results posted below represent a change in score from baseline. A positive change represents an improvement on the ADAS-Cog (change = 1 month score - baseline score).|Pre treatment; 1 month post treatment|||percentage change||Standard Deviation|Mean
685323|NCT01504867|Secondary|Mean Hospital Length of Stay||approximately 7 days|Intention-to-Treat||days||Standard Deviation|Mean
685324|NCT01504867|Secondary|Number of Subjects Admitted to Intensive Care Unit (ICU)||7 days|Intention-to-Treat||participants|||Number
685325|NCT01504867|Secondary|Mean Number of Days Participants Were Ventilator-Free To Day 28||baseline, Day 28|Intention-to-Treat||days||Standard Deviation|Mean
685326|NCT01504867|Secondary|Number of Subjects With Mechanical Ventilation at Any Time During Hospitalization||approximately 7 days|Intention-to-Treat||participants|||Number
685327|NCT01504867|Secondary|Number of Participants With ARDS or Mortality Within 7 Days||within 7 days|||participants|||Number
685328|NCT01504867|Secondary|Hospital Mortality||28 days|Intention-to-Treat||participants|||Number
685329|NCT01504867|Primary|Number of Participants Who Developed Acute Respiratory Distress Syndrome (ARDS) Within 7 Days|ARDS was defined by Berlin criteria (modified to require invasive mechanical ventilation) within 7 days of hospital admission.|Within seven days from hospital presentation|Intention-to-Treat||participants|||Number
685330|NCT01504854|Secondary|Comparison of the Response to Treatment of Resveratrol Based on ApoE Genotype|CSF Abeta40|Week 52|ITT analyses. Total population and subpopulation of ApoE4 non-carriers.||ng/ml||Standard Deviation|Mean
685331|NCT01504854|Secondary|Change in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)|The ADCS-ADL is an activities of daily living inventory developed by the ADCS to assess functional performance in participants with AD. The ADCS-ADL includes some items from traditional basic ADL tests (e.g., grooming, dressing, walking, bathing, feeding, toileting) as well as instrumental (complex) activities of daily living (e.g., shopping, preparing meals, using household appliances, keeping appointments, reading). This structured questionnaire is administered to the subject's caregiver/study partner. The range of this instrument is 0 to 78 with lower numbers indicating greater impairment.|Week 52|||units on a scale||Standard Deviation|Mean
685332|NCT01504854|Primary|Change From Baseline in Volumetric Magnetic Resonance Imaging (MRI)|MRI will be used to assess the effect of treatment on rate of whole brain volume|Baseline and Week 52|ITT population||cm^3||Standard Deviation|Mean
685333|NCT01504854|Primary|Number of Adverse Events|The safety and tolerability of treatment with resveratrol will be assessed by analysis of adverse events, including symptoms, abnormal findings on physical examinations, standard laboratory tests and PK analysis of resveratrol and its major metabolites. The frequencies of adverse events or laboratory abnormalities between the participants who receive resveratrol and those receiving placebo will be compared.|Baseline, Weeks 6, 13, 19, 26, 32, 39, 45, and 52|ITT population||number of AEs|||Number
685334|NCT01504854|Post-Hoc|Change From Baseline in Cerebrospinal Fluid Amyloid β40 Concentration at 52 Weeks|Mean change from baseline in cerebrospinal fluid amyloid β40 concentration at 52 weeks|Baseline and Week 52|Post-hoc modified intention-to-treat (ITT) re-analysis of primary outcomes at Week 52 adjusting for age and AD duration in the mixed-model repeated measures model||ng/ml||Standard Deviation|Mean
685335|NCT01503749|Secondary|Mean Change in Child-Pugh Score and Model For End-Stage Liver Disease (MELD) Score|The efficacy (mean change in Child-Pugh score and Model For End-Stage Liver Disease score [at weeks 24]) of ultrasound-guided percutaneous portal transplantation of peripheral blood monocyte cell in cirrhotic patients. MELD Score = (0.957 * ln(Serum Cr) + 0.378 * ln(Serum Bilirubin) + 1.120 * ln(INR) + 0.643 ) * 10 (if hemodialysis, value for Creatinine is automatically set to 4.0) (minimum <9: 1.9% mortality; maximum 40 or more: 71.3% mortality). Child-Pugh score = Bilirubin (mg/dl): <2 (1 point),2-3 (2 points), >3 (3 points) + Albumin (g/dl): >3.5 (1 point),3.5-2.8 (2 points), <2.8 (3 points) + PT prolongation (INR): <4 seconds (<1.7) (1 point), 4-6 seconds (1.7-2.3) (2 points),>6 seconds (>2.3) (3 points) + Ascites: Absent (1 point), Slight (2 points), Moderate (3 points) + Encephalopathy: Absent (1 point), Mild (I-II) (2 points), Severe (III-IV) (3 points) ; Class A: 5-6, Class B: 7-9, Class C: 10-15 (minimum 5, maximum 15; higher Child-Pugh score with worse prognosis)|Baseline and Week 24|A total of 9 decompensated cirrhotic patients (5 men and 4 females, age range 45–71 years) grouped by randomization.||score||Standard Deviation|Mean
685336|NCT01503749|Primary|Number of Participants With Severe Adverse Events|No serious adverse event. Minor adverse events (not considered to be related to this study), as follows; Control: 6 events (ascites and pleural tapping, gum bleeding, ascties tapping x3, diarrhea) G-colony stimulating factor group: 6 events (percutaneous vertebroplasty, abdominal pain and nausea, hyperkalemia, ascties tapping, diarrhea, liver transplantation) Infusion of the mobilized peripheral blood mononucleated cells group: 1 event (hepatic encephalopathy)|up to 6 months|Nine patients who fulfilled the inclusion and exclusion criteria.||participants|||Number
685337|NCT01503021|Other Pre-specified|Incidence of Patients Meeting Hy's Law Criteria|The peak alanine aminotransferase and the peak total bilirubin levels were evaluated per patient. Laboratory values for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. Patients with alanine aminotransferase more than three times the upper limit of normal and also total bilirubin more than two times the upper limit of normal are counted.|Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).||participants|||Number
685338|NCT01503021|Other Pre-specified|Transferrin Saturation|The baseline and end of treatment predialysis transferrin saturation were evaluated for the 52-week extension study to confirm clearance of iron derived from soluble ferric pyrophosphate.|Baseline, up to 53 weeks for Extension Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).||percent transferrin saturation||Standard Deviation|Mean
685339|NCT01503021|Other Pre-specified|Serum Iron|The baseline and end of treatment predialysis serum iron levels were evaluated for the 52-week extension study to determine the effect of soluble ferric pyrophosphate on serum iron.|Baseline, up to 53 weeks for Extension Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).||micromoles per liter||Standard Deviation|Mean
685340|NCT01503021|Other Pre-specified|Ferritin|The baseline and end of treatment predialysis ferritin levels were evaluated for the 52-week extension study to determine whether soluble ferric pyrophosphate increases iron stores.|Baseline, up to 53 weeks for Extension Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).||micrograms per liter||Standard Deviation|Mean
685341|NCT01503021|Other Pre-specified|Transferrin Saturation Change From Pre-dialysis to Post-dialysis at Week 5|Transferrin saturation (based on TIBC derived from transferrin levels) was assessed from samples obtained pre-dialysis and post-dialysis at a single hemodialysis during study week 5. Because of the crossover nature of the study, the week 5 values reflect effects of Placebo in the SFP/Placebo arm and effects of SFP in the Placebo/SFP arm.|Pre-dialysis and post-dialysis during study week 5 of the Parent (Crossover) Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).||percent transferrin saturation||Standard Deviation|Mean
685342|NCT01503021|Other Pre-specified|Transferrin Saturation Change From Pre-dialysis to Post-dialysis at Week 2|Transferrin saturation (based on TIBC derived from transferrin levels) was assessed from samples obtained pre-dialysis and post-dialysis at a single hemodialysis during study week 2. Because of the crossover nature of the study, the week 2 values reflect effects of SFP in the SFP/Placebo arm and effects of Placebo in the Placebo/SFP arm.|Pre-dialysis and post-dialysis during study week 2 of the Parent (Crossover) Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).||percent transferrin saturation||Standard Deviation|Mean
685343|NCT01503021|Other Pre-specified|Unsaturated Iron-binding Capacity Change From Pre-dialysis to Post-dialysis at Week 5|Unsaturated iron-binding capacity was assessed from samples obtained pre-dialysis and post-dialysis at a single hemodialysis during study week 5. Because of the crossover nature of the study, the week 5 values reflect effects of Placebo in the SFP/Placebo arm and effects of SFP in the Placebo/SFP arm.|Pre-dialysis and post-dialysis during study week 5 of the Parent (Crossover) Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).||micromoles per liter||Standard Deviation|Mean
685344|NCT01503021|Other Pre-specified|Unsaturated Iron-binding Capacity Change From Pre-dialysis to Post-dialysis at Week 2|Unsaturated iron-binding capacity was assessed from samples obtained pre-dialysis and post-dialysis at a single hemodialysis during study week 2. Because of the crossover nature of the study, the week 2 values reflect effects of SFP in the SFP/Placebo arm and effects of Placebo in the Placebo/SFP arm.|Pre-dialysis and post-dialysis during study week 2 of the Parent (Crossover) Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).||micromoles per liter||Standard Deviation|Mean
685345|NCT01503021|Other Pre-specified|Serum Iron Change From Pre-dialysis to Post-dialysis at Week 5|Serum iron was assessed from samples obtained pre-dialysis and post-dialysis at a single hemodialysis during study week 5. Because of the crossover nature of the study, the week 5 values reflect effects of Placebo in the SFP/Placebo arm and effects of SFP in the Placebo/SFP arm.|Pre-dialysis and post-dialysis during study week 5 of the Parent (Crossover) Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).||micromoles per liter||Standard Deviation|Mean
685346|NCT01503021|Other Pre-specified|Serum Iron Change From Pre-dialysis to Post-dialysis at Week 2|Serum iron was assessed from samples obtained pre-dialysis and post-dialysis at a single hemodialysis during study week 2. Because of the crossover nature of the study, the week 2 values reflect effects of SFP in the SFP/Placebo arm and effects of Placebo in the Placebo/SFP arm.|Pre-dialysis and post-dialysis during study week 2 of the Parent (Crossover) Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).||micromoles per liter||Standard Deviation|Mean
685347|NCT01503021|Secondary|Incidence of Serious Adverse Events|Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. For each adverse event, investigators assessed whether the event met seriousness criteria.|Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).||percentage of participants|||Number
685348|NCT01503021|Secondary|Incidence of Systemic/Serious Infections|Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. Adverse events of systemic/serious infections were defined in the statistical analysis plan for the study to include infections for which the subject was administered at least 3 doses of an IV antibiotic, and infections for which the subject was hospitalized.|Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).||percentage of participants|||Number
685349|NCT01503021|Secondary|Incidence of Other Thrombotic Events|Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. Adverse event terms meeting criteria for other thrombotic events were pre-specified in the statistical analysis plan for the study.|Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).||percentage of participants|||Number
685396|NCT01502033|Primary|Children's Depression Rating Scale-Revised (CDRS-R) Post Treatment 30 or Last Treatment (in Cases of Early Withdrawal)|The Children's Depression Rating Scale-Revised (CDRS-R) is a validated, 17-item, semi-structured clinician rating tool to assess severity of depression with subject and parental input for 14 of the 17 items.|5 days of Treatment 30 or Last Treatment|||units on a scale||Standard Deviation|Mean
685350|NCT01503021|Secondary|Incidence of Hemodialysis Vascular Access Thrombotic Events|Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. Adverse event terms meeting criteria for hemodialysis vascular access thrombotic events were pre-specified in the statistical analysis plan for the study.|Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).||percentage of participants|||Number
685351|NCT01503021|Secondary|Incidence of Composite Cardiovascular Events|Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. Adverse event terms meeting criteria for composite cardiovascular events were pre-specified in the statistical analysis plan for the study.|Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).||percentage of participants|||Number
685352|NCT01503021|Primary|Incidence of Related Suspected Hypersensitivity Reactions|Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. For each adverse event, investigators assessed whether the event met protocol criteria for suspected hypersensitivity reactions.|Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).||percentage of participants|||Number
685353|NCT01503021|Primary|Incidence of Treatment-emergent Adverse Events of Intradialytic Hypotension|Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. For each adverse event, investigators assessed whether the event met the protocol criteria for intradialytic hypotension. Intradialytic hypotension events were only to have been reported as adverse events if they exceeded the individual subject's baseline pattern of intradialytic hypotension.|Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).||percentage of participants|||Number
685354|NCT01503021|Primary|Incidence of Treatment-emergent Adverse Events|Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention.|Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).||percentage of participants|||Number
685355|NCT01502787|Secondary|Blood Pressure During Angiotensin II Infusion||12 weeks after initiation of nebivolol||||||
685356|NCT01502787|Secondary|Blood Pressure During Angiotensin II Infusion||12 weeks after initiation of metoprolol||||||
685357|NCT01502787|Secondary|Blood Pressure During Exercise||12 weeks after initiation of nebivolol||||||
685358|NCT01502787|Secondary|Blood Pressure During Exercise||12 weeks after initiation of metoprolol||||||
685359|NCT01502787|Primary|Sympathetic Nerve Activity (SNA) During Angiotensin II Infusion||12 weeks after initiation of nebivolol||||||
685360|NCT01502787|Primary|Sympathetic Nerve Activity (SNA) During Angiotensin II Infusion||12 weeks after initiation of metoprolol||||||
685361|NCT01502787|Primary|Sympathetic Nerve Activity (SNA) During Exercise||12 weeks after initiation of nebivolol||||||
685362|NCT01502787|Primary|Sympathetic Nerve Activity (SNA) During Exercise||12 weeks after initiation of metoprolol||||||
685363|NCT01502787|Primary|Forearm Blood Flow||12 weeks after each specified medication|||ml/min||Standard Deviation|Mean
685364|NCT01502761|Secondary|Number of Participants With Procedure Related Serious Adverse Event|Periprocedural clinical, radiographic and laboratory data will be collected and analyzed to detect Mg related adverse events. Outcome will be assessed perioperatively and at 24 hours, 30 days (+/- 10 days) and 90 days (+/- 15 days)|intraprocedure, postoperative day 1, 1 month, 3 month|||Participants|||Count of Participants
685365|NCT01502761|Primary|Magnesium Concentration in Region of Cerebral Ischemia|Peripheral Magnesium Levels, meq/L will be obtained through the femoral sheath at the beginning (baseline) and end (post-treatment) of each case. These will be averaged to obtain a femoral Magnesium level. Magnesium levels distal to the occlusion will be measured at the first pass of the clot retrieving device.|Mg level: 1) Peripheral: Baseline and post-treatment (averaged); 2) Distal: after first pass of the clot retriever|Enrollment only occurred in the first arm (lowest dose) of the study as the arms were planned to enroll sequentially. The study was not stopped due to safety concerns||meq/L||Standard Deviation|Mean
685366|NCT01502709|Secondary|Number of Participants With Signs and Symptoms of Temporomandibular Disorder Based on Outcomes of Research Diagnostic Criteria (RDC) Exam|RDC for Temporomandibular disorders (TMD) is a reliable & valid system for diagnosis of TMD, utilizing clinical procedures, diagnostic algorithms, and a dual-axis assessment comprising symptom history and physical exam. Signs and symptoms were evaluated by a trained professional and the history was obtained through use of questionnaires. In all sections and scales the higher the number reported corresponds to the more pain being experienced, therefore, a worse outcome. The clinical exam consists of facial, dental, and cervical evaluations including mandibular range of motion, Temporomandibular disorders Joint sound, and palpation of the orofacial muscles and temporomandibular joints (TMJ). Subjects are classified as TMD if they report pain in or around the temporomandibular joints or muscles of mastication for more than 3 months.|Baseline, Month 3|||Participants|||Number
685367|NCT01502709|Secondary|Mean Percentage of Time Spent in Pain From Days 1-7|The mean of measures taken from days 1-7 was calculated. Composite pain is a measure of mean pain intensity experienced and pain duration. Pain was assessed by using VAS score ranges from 0 millimeter (mm) = no pain to 100 mm = worst possible pain. Duration of pain ranges from 0 to 100% of a day. For example a pain free subject would report O pain intensity for 0% of the day.|Days 1-7|||percentage of day in pain||Standard Deviation|Mean
685368|NCT01502709|Primary|Change From Baseline in Visual Analog Score (VAS) in Days 1-7 Post Treatment|The mean of measures taken from days 1-7 was calculated. Pain was assessed by using VAS score ranges from 0 millimeter (mm) = no pain to 100 mm = worst possible pain. A decrease in score from Baseline represented treatment response.|Daily Self-reports at Baseline and on Days 1 through 7|||millimeters||Standard Deviation|Mean
685369|NCT01502644|Primary|Percent Change in Average Daily Pain Score|Participants rated their average lower back pain over the past 24 hours using an 11-point scale (0=no pain to 10=worst possible pain) and recorded it in an electronic diary. The percent change in pain score from baseline is calculated using weekly averages for up to 20 weeks. Linear mixed modeling (LMM) analysis was used to allow for inclusion in the analysis of the majority of participants with any missing data. For the LMM model, group, group × week, average baseline pain, and opioid use at baseline (yes/no) were entered as fixed effects using an autoregressive covariance structure. Participant, intercept, and week were entered as random effects, using a compound symmetry covariance structure. A positive change from baseline indicates an improvement.|Baseline and Week 20|Modified Intent-to-Treat Population, all participants who completed at least 50% of the opioid treatment period (at least 10 weeks of treatment).||percent change||Standard Deviation|Mean
685370|NCT01502423|Secondary|Number of Participants With Adverse Events (AEs)|An AE was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment.|Adverse events were collected from the time of study drug administration until 70 days following discontinuation of study drug. Serious adverse events were collected from the time that participant signed the informed consent.|||participants|||Number
685371|NCT01502423|Secondary|Percentage of Participants With no Pruritus in the Draize Scale|Pruritus (itching) was assessed.|10 minutes and 30 minutes after injection|||Percentage of Participants|||Number
685372|NCT01502423|Secondary|Percentage of Participants With no Edema in the Draize Scale|Edema (swelling) was assessed.|10 minutes and 30 minutes after injection|||Percentage of Participants|||Number
685373|NCT01502423|Secondary|Percentage of Participants With no Erythema in the Draize Scale|Erythema (redness) was assessed.|10 minutes and 30 minutes after injection|||Percentage of Participants|||Number
685374|NCT01502423|Secondary|Percentage of Participants With no Hemorrhage/Petechiae in the Draize Scale|Hemorrhage/petechiae (bleeding/spots of bleeding underneath the skin) was assessed.|10 minutes and 30 minutes after injection|||Percentage of Participants|||Number
685375|NCT01502423|Secondary|Mean Injection Site Pain on a Visual Analogue Scale (VAS)|The secondary response variable is participant's pain of injection on a visual analogue scale (VAS) of 0 to 10 (cm) recorded 15 minutes after the injection.|15 minutes post injection|||cm||Standard Deviation|Mean
685376|NCT01502423|Primary|Mean Injection Site Pain on a Visual Analogue Scale (VAS)|The primary response variable is participant's immediate pain of injection on a visual analogue scale (VAS) of 0 to 10 (cm), with 0 representing no pain and 10 representing the worst possible pain.|Immediately after injection.|||cm||Standard Deviation|Mean
685377|NCT01502410|Secondary|Presence of BRAF Mutation or RET/PTC Rearrangement|Descriptive statistics including mean, median, standard deviation, and range will be calculated for baseline for patients with PTC, TG and TG antibody, and presence of BRAF mutation or RET/PTC rearrangement.|At baseline||||||
685378|NCT01502410|Secondary|Change in VEGF and VEGFR-2|Descriptive statistics including mean, median, standard deviation, and range will be calculated for baseline and steady state VEGF and VEGFR-2. Changes from baseline to steady state on treatment with sorafenib will be evaluated using non-parametric paired tests if there is evidence of intra-patient correlation as assessed by Spearman's rank correlation.|From baseline to day 15 of course 1||||||
685379|NCT01502410|Secondary|Pharmacokinetic (PK) Parameters of Sorafenib Tosylate|The PK parameters will be summarized with simple summary statistics, including means, medians, ranges, and standard deviations (if numbers and distribution permit).|At baseline, up to 12 hours and on day 15 of course 1, and prior to odd courses||||||
685380|NCT01502410|Secondary|Toxicity as Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0||Up to 5 years||||||
685381|NCT01502410|Secondary|Progression-free Survival According to RECIST Version 1.1|Progression-free interval (PFI) will be calculated as the date of enrollment until the end PFI date, where that date is calculated as the date of disease progression, date of death, date of removal of all tumors by surgery or last patient contact, whichever occurs first.|From date of enrollment to the date of disease progression, date of death, date of removal of all tumor by surgery or last patient contact, whichever occurs first, assessed up to 5 years||||||
685382|NCT01502410|Primary|Objective Response by RECIST Criteria v 1.1|Response rates will be calculated as the number of evaluable patients who are responders. Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): Disappearance of all target lesions, Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD, Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started and Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|6 cycles (168 days)|||participants|||Number
685383|NCT01502371|Secondary|Change From Baseline in Percent Predicted AM FEV1 - MF MDI 50 mcg BID vs. MF DPI 100 mcg QD|FEV1 is the amount of air, measured in liters, forcibly exhaled in 1 second. Pulmonary function tests were to be performed by participants in the morning before dosing. The percent predicted FEV1 equals the participant's observed FEV1 divided by the participant's predicted FEV1 (determined by height and race) and converted to a percentage by multiplying by 100%. The goal of the secondary outcome measure was to compare the change from Baseline in AM FEV1 between the MF MDI 50 mcg BID and MF DPI 100 mcg QD treatment groups. The comparisons between the other MF MDI BID and Placebo treatment groups are presented in a previous outcome measure.|Baseline and Week 12|The FAS population consisted of all participants who received ≥1 study drug dose and had a Baseline or ≥1 post-randomization value for this outcome measure. Only participants who received MF MDI 50 mcg or MF DPI were included in this secondary analysis.||Percentage of Predicted FEV1||95% Confidence Interval|Least Squares Mean
685397|NCT01501162|Secondary|Lipopolysaccharide (LPS) and Pro-inflammatory Cytokines|For the measurements of cytokines, homogenates of serum were processed with Human Tumor necrosis factor-alpha ELISA Kit and Human interleukin 1 beta ELISA Kit . For the measurement of LPS ELISA Kit was used. Assays were performed according to the manufacturer's instructions.|7 days after probiotics|||EU/mL||Standard Deviation|Mean
685398|NCT01501162|Primary|Liver Enzymes(ALT)|Blood analysis was performed using standard methodologies.|7 days after probiotics|||IU/L||Standard Deviation|Mean
685399|NCT01501110|Primary|Serum T3 Levels at 48 Hours||48 hours|||ng/dL||Standard Deviation|Mean
685384|NCT01502371|Secondary|Change From Baseline in Paediatric Asthma Quality of Life Questionnaire With Standardised Activities (PAQLQ(S)) Total Score - MF MDI vs. Placebo|The PAQLQ(S) consists of 23 questions in 3 categories: Symptoms (10 items), Activity Limitations (5 items), and Emotional Function (8 items). Responses are based on a 7-point scale (7=not bothered at all to 1=extremely bothered). PAQLQ(S) Total Scores could range from 23 to 161, with a lower score indicating a lower quality of life. The PAQLQ(S) included only participants in participating countries in which a validated translated questionnaire was available. The goal of the secondary outcome measure was to compare the change from Baseline in PAQLQ(S) between the MF MDI and Placebo treatment groups.|Baseline and Week 12|The FAS population consisted of all participants who received ≥1 study drug dose and had a Baseline or ≥1 post-randomization value for this outcome measure.||Score on a Scale||95% Confidence Interval|Least Squares Mean
685385|NCT01502371|Secondary|Change From Baseline in AM Peak Expiratory Flow (PEF) - MF MDI vs. Placebo|PEF, measured in liters per minute, is the highest flow during exhalation. Participants recorded diary entries for PEF twice daily (in the morning upon rising and in the evening at bedtime). The goal of the secondary outcome measure was to compare the change from Baseline in AM PEF between the MF MDI and Placebo treatment groups.|Baseline and Week 12|The FAS population consisted of all participants who received ≥1 study drug dose and had a Baseline or ≥1 post-randomization value for this outcome measure.||Liters/minute||95% Confidence Interval|Least Squares Mean
685386|NCT01502371|Primary|Change From Baseline in Percent Predicted Morning (AM) Forced Expiratory Volume in 1 Second (FEV1) - MF MDI vs. Placebo|FEV1 is the amount of air, measured in liters, forcibly exhaled in 1 second. Pulmonary function tests were to be performed by participants in the morning before dosing. The percent predicted FEV1 equals the participant's observed FEV1 divided by the participant's predicted FEV1 (determined by height and race) and converted to a percentage by multiplying by 100%. The goal of the primary outcome measure was to compare the change from Baseline in AM FEV1 between the MF MDI and Placebo treatment groups. The comparison between the MF MDI 50 mcg BID vs. MF DPI 100 mcg QD treatment groups is presented in a subsequent outcome measure.|Baseline and Week 12|The Full Analysis Set (FAS) population consisted of all participants who received ≥1 study drug dose and had a Baseline or ≥1 post-randomization value for this outcome measure. Only participants who received MF MDI or Placebo were included in this primary analysis.||Percentage of Predicted FEV1||95% Confidence Interval|Least Squares Mean
685387|NCT01502332|Secondary|Hospital Mortality|Deaths occurred during hospital stay, tested with logistic regression.|From the day of surgery up to Hospital discharge or death, with no maximum censoring.|||percentage of participants|||Number
685388|NCT01502332|Secondary|Incidence of Barotrauma|Confirmed by X-ray. Test with logistic regression|Five days after surgery|||percentage of participants|||Number
685389|NCT01502332|Secondary|Length of Hospital Stay|Days since surgery until Hospital discharge, analyzed through Kaplan-Meyer curves (log-Rank test), where the time to event is the time of discharge from the Hospital. The censoring was performed at 28 days. Patients dying before leaving the Hospital were censored as not discharged from Hospital at day 28.|From the day of surgery up to Hospital discharge, maximum censoring at day 28 after surgery|||days||Inter-Quartile Range|Median
685390|NCT01502332|Secondary|Length of ICU Stay|Days since surgery until ICU discharge, analyzed through Kaplan-Meyer curves (log-Rank test), where the time to event is the time of discharge from the ICU. The censoring was performed at 28 days. Patients dying before leaving the ICU were censored as not discharged from ICU at day 28.|From the day of surgery up to ICU discharge, maximum censoring at day 28 after surgery|||days||Inter-Quartile Range|Median
685391|NCT01502332|Primary|Severity of Pulmonary Complications in the Post-operative Period|"Score of pulmonary complications adapted from previous publications, with 5 degrees, where the higher one means death before hospital discharge, degree (4) means the need of mechanical ventilation for more than 48 hours after surgery or after reintubation, degree (3) means pneumonia or intense noninvasive ventilation need, degree (2) means hypoxemia and abnormal lung findings, degree 1 means simple atelectasis and degree (0) means no complication.
The comparison used this ordinal variable, representing the highest score achieved during the post-operative period. The comparison between arms was made through the Mann-Whitney U test.
Data shown are percentage of participants with pulmonary complications grade ≥ 3."|Participants were followed for the duration of hospital stay.|||percentage of participants|||Number
685392|NCT01502228|Secondary|Maximum Standard Uptake Value (SUV) for Lesion Data|Average values of the magnitude of tumor perfusion before and 14-28 days after initiation of Sunitinib treatment as measured by the maximum standard uptake value for all the lesion data. Standard uptake values were calculated as the ratio of the image derived radioactivity concentration and the whole body concentration of the injected radioactivity tracer. There were 14 patients who had a baseline reading and 12 patients who had a reading after treatment.|Baseline and 14-28 days after initiation of Sunitinib|||SUV||Standard Deviation|Mean
685393|NCT01502228|Primary|Number of Patients Where 62Cu-ETS PET and 15O-water PET Was Obtained|Number of patients who had at least a baseline measurement of 62Cu-ETS PET and 15O-water PET|Baseline|All Patients Enrolled.||Participants|||Count of Participants
685394|NCT01502033|Secondary|The Clinical Global Impression - Improvement (CGI-I)|The Clinical Global Impression - Improvement (CGI-I) is a standardized assessment utilizing a 7-point scale with which the clinician rates improvment of the subject's depressive illness at the time of assessment relative to the clinician's past experience with patients with the same diagnosis. Range of scale is 1-7 (1= very much improved, 7=very much worse) larger number indicates greater severity of symptoms or worse outcome).|Within 5 days of 30 treatments or after last treatment in case of early withdrawal|||units on a scale||Standard Deviation|Mean
685395|NCT01502033|Secondary|Clinical Global Impression - Severity (CGI-S) Post Treatment 30 or Last Treatment (in Cases of Early Withdrawal)|The Clinical Global Impression - Severity (CGI-S) is a standardized assessment utilizing a 7-point scale with which the clinician rates severity of the subject's depressive illness at the time of assessment relative to the clinician's past experience with patients with the same diagnosis. Range of scale is 1-7 (1= normal, not ill at all; 7= among the most ill patients; larger number indicates greater severity of symptoms or worse outcome).|Within 5 days of Treatment 30 or Last Treatment|||units on a scale||Standard Deviation|Mean
685400|NCT01500772|Secondary|Percentage of Participants Who Discontinued Study Drug or Required Dose Reduction or Dose Interruption Due to Treatment-emergent Adverse Events||48 weeks|The study was terminated before the outcome measure time point.|||||
685403|NCT01500772|Primary|Percentage of Participants Who Achieved Sustained Viral Response (SVR) 12 Weeks After End of Treatment (SVR12)|SVR12 was defined as hepatitis C (HCV) ribonucleic acid (RNA) laboratory value below level of quantification (LOQ) (i.e., 25 IU/ml) 12 weeks after the end of treatment.|12 weeks posttreatment|The study was terminated before the outcome measure time point.|||||
685404|NCT01500746|Secondary|Pain With Lavage Treatments|After each lavage treatment, the subjects will complete a visual analogue scale that will determine the level of discomfort that they experienced during the study.|4 days||||||
685405|NCT01500746|Primary|Change in Gene Expression Analysis|A punch biopsy will be taken at the beginning of the study. this will be sent for gene expression analysis. A repeat biopsy at the end of the study will also be sent at the end of the study, and a change in gene expression in analysis will be evaluated.|4 days||||||
685406|NCT01500746|Primary|Change in Bacterial Counts|A punch biopsy of the wound will be taken once the subject is enrolled in the study. A repeat biopsy will be taken after the 8th lavage treatment or the 8th dressing change. These will be sent for bacterial count analysis and the difference in bacterial counts will be evaluated. The lavage fluid from baseline measurements will be filtered and sent for bacterial counts and will be compared to the filtered fluid from the last lavage treatment. In addition, surface swabs will be taken at the beginning and end of the study and will be sent for bacterial counts as well. Bacterial counts from these lavage, biopsy specimen, and swabs will be averaged and analyzed.|Baseline and at 4 days|||cfu/mL||Full Range|Mean
685407|NCT01500720|Secondary|Overall Objective Tumor Response Rate|Overall objective tumor response was defined as the proportion of participants with confirmed RECIST 1.1 achieving a complete response (CR) or partial response (PR). CR was defined as disappearance of all target/non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Percentage of participants with overall objective tumor response is reported.|Randomization to disease progression/occurrence (maximum 7.6 months)|ITT population.||percentage of participants||95% Confidence Interval|Number
685408|NCT01500720|Secondary|Progression Free Rate at Week 12|Progression was defined using Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1) as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study or unequivocal progression of existing non-target lesion. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. Death due to disease progression within 12 weeks without radiological documentation of progressive disease was counted as an event. Percentage of participants who were progression free at week 12 are reported.|Week 12|ITT population.||percentage of participants||95% Confidence Interval|Number
685409|NCT01500720|Secondary|Overall Survival|Overall survival was defined as the time interval from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, survival time was to be censored at the last date the participant was known to be alive. Median time was estimated by Kaplan-Meier curve.|From randomization to date of death (maximum 15 months)|ITT population.||months||95% Confidence Interval|Median
685410|NCT01500720|Primary|Progression Free Survival (PFS)|PFS was defined as the time interval from the date of randomization to the date of occurrence of the first documented tumor progression or death due to any cause, whichever came first. Median PFS was estimated using the Kaplan-Meier method. Progression was defined using Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1) as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study or unequivocal progression of existing non-target lesion. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). The appearance of one or more new lesions is also considered progression.|Randomization to first tumor progression/clinical deterioration or death (maximum 7.6 months)|Intent-to-treat (ITT) population included all randomized participants.||months||95% Confidence Interval|Median
685411|NCT01500694|Secondary|Number of Participants Assessed With Clinical Global Impression Severity of Illness (CGI-S) Scale|The CGI-S evaluate each participant's severity and improvement over time. The severity of a participant’s condition is rated on a 7-point scale ranging from 1 to 7. The scale measures 0 = Not assessed, 1 = Normal, not at all ill, 2 = Borderline mentally ill (BL-MI), 3 = Mildly ill, 4 = Moderately ill, 5 = Markedly ill, 6 = Severely ill, 7 = Among the most extremely ill participant. Final Assessment is the last valid assessment obtained after Baseline (Visit 2/Day 0) whilst on investigational product and before first dose taper medication (Visit 19/ET/Day 714).|Baseline (Day 0) and Final Assessment (last non missing data/up to Day 714)|Full Analysis Set included enrolled participants who took at least 1 dose of SPD503, excluding participants from site 403. Here, n = number of participants analysed for the specific categories for each arm respectively.||participants|||Number
685412|NCT01500694|Secondary|Change From Baseline in Attention-deficit and Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) - Total Score at Final Assessment|ADHD-RS-IV was developed to measure the behaviours of children with ADHD with 18 items. Each item is scored from a range of 0 (reflecting no symptoms) to 3 (reflecting severe symptoms) with total scores ranging from 0-54. The 18 items may be grouped into 2 subscales: hyperactivity/impulsivity (even numbered items 2-18) and inattentiveness (odd numbered items 1-17) with possible score range from 0 (no symptoms) to 27 (most severe symptoms). The ADHD-RS-IV possible total scores range from 0 (no symptoms) to 54 (most severe symptoms). Final Assessment is the last valid assessment obtained after Baseline (Visit 2/Day 0) whilst on investigational product and before first dose taper medication (Visit 19/ET/Day 714).|Baseline (Day 0) and Final Assessment (last non missing data/up to Day 714)|Full Analysis Set included enrolled participants who took at least 1 dose of SPD503, excluding participants from site 403. Here, n = number of participants analysed for the specific categories for each arm respectively.||units on a scale||Standard Error|Mean
685424|NCT01500629|Secondary|Change From Baseline of the Total Score From the Following Nasal Symptoms (TNSSX [Total Nasal Symptom Score Excluding Sneezing]): Itchy Nose, Runny Nose, Nasal Congestion at 15 Minutes After the First Allergen Challenge|TNSSX was derived by taking the sum of the average score of left and right nostrils for itchy nose, runny nose, and nasal congestion. Change from baseline of TNSSX was TNSSX for each post baseline time point minus its baseline. For the change from baseline of TNSSX, the total possible minimum value is 0 (best) and the total possible maximum value is 9 (worst).|within 15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||units on a scale||Standard Error|Mean
685413|NCT01500694|Primary|"Number of Participants With Suicidal Behavior and / or Ideation (Yes Response) on the Columbia Suicide Severity Rating Scale (C-SSRS)"|"C-SSRS is a clinician rated assessment of suicidal behavior and / or intent categorized as: Suicidal behavior=a yes response to any of 5 suicidal behavior questions (preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide); Suicidal ideation=a yes response to any one of 5 suicidal ideation questions which includes wish to be dead, and 4 different categories of active suicidal ideation (thought, thought with method, thought with intent, thought with plan and intent)."|Final Assessment (last non missing data/up to Day 714)|Safety Analysis Set included all enrolled participants who took at least 1 dose of SPD503 with number of participants evaluable for this outcome at specific categories.||participants|||Number
685414|NCT01500694|Primary|Change From Baseline in Electrocardiogram Result (QT Interval) at Final Assessment|Final Assessment is the last valid assessment obtained after Baseline (Visit 2/Day 0) whilst on investigational product and before first dose taper medication (Visit 19/ET/Day 714).|Baseline (Day 0) and Final Assessment (last non missing data/up to Day 714)|Safety Analysis Set included all enrolled participants who took at least 1 dose of SPD503. Here, n = number of participants analysed for the specific categories for each arm respectively.||millisecond (ms)||Standard Deviation|Mean
685415|NCT01500694|Primary|Change From Baseline in Electrocardiogram Result (QRS Interval) at Final Assessment|Final Assessment is the last valid assessment obtained after Baseline (Visit 2/Day 0) whilst on investigational product and before first dose taper medication (Visit 19/ET/Day 714).|Baseline (Day 0) and Final Assessment (last non missing data/up to Day 714)|Safety Analysis Set included all enrolled participants who took at least 1 dose of SPD503. Here, n = number of participants analysed for the specific categories for each arm respectively.||millisecond (ms)||Standard Deviation|Mean
685416|NCT01500694|Primary|Change From Baseline in Mean Weight at Final Assessment|Final Assessment is the last valid assessment obtained after Baseline (Visit 2/Day 0) whilst on investigational product and before first dose taper medication (Visit 19/ET/Day 714).|Baseline (Day 0) and Final Assessment (last non missing data/up to Day 714)|Safety Analysis Set included all enrolled participants who took at least 1 dose of SPD503. Here, n = number of participants analysed for the specific categories for each arm respectively.||kilogram (kg)||Standard Deviation|Mean
685417|NCT01500694|Primary|Change From Baseline in Mean Height at Final Assessment|Final Assessment is the last valid assessment obtained after Baseline (Visit 2/Day 0) whilst on investigational product and before first dose taper medication (Visit 19/ET/Day 714).|Baseline (Day 0) and Final Assessment (last non missing data/up to Day 714)|Safety Analysis Set included all enrolled participants who took at least 1 dose of SPD503. Here, n = number of participants analysed for the specific categories for each arm respectively.||centimeter (cm)||Standard Deviation|Mean
685418|NCT01500694|Primary|Change From Baseline in Mean Supine Pulse at Final Assessment|Pulse was measured at supine and standing position and mean supine pulse was reported here. Final Assessment is the last valid assessment obtained after Baseline (Visit 2/Day 0) whilst on investigational product and before first dose taper medication (Visit 19/ET/Day 714).|Baseline (Day 0) and Final Assessment (last non missing data/up to Day 714)|Safety Analysis Set included all enrolled participants who took at least 1 dose of SPD503. Here, n = number of participants analysed for the specific categories for each arm respectively.||beats per minute (bpm)||Standard Deviation|Mean
685419|NCT01500694|Primary|Change From Baseline in Mean Diastolic Blood Pressure at Final Assessment|Diastolic Blood pressure was measured at supine and standing position and mean supine diastolic blood pressure was reported here. Final Assessment is the last valid assessment obtained after Baseline (Visit 2/Day 0) whilst on investigational product and before first dose taper medication (Visit 19/ET/Day 714).|Baseline (Day 0) and Final Assessment (last non missing data/up to Day 714)|Safety Analysis Set included all enrolled participants who took at least 1 dose of SPD503. Here, n = number of participants analysed for the specific categories for each arm respectively.||millimeter of mercury (mmHg)||Standard Deviation|Mean
685420|NCT01500694|Primary|Change From Baseline in Mean Systolic Blood Pressure at Final Assessment|Systolic Blood pressure was measured at supine and standing position and mean supine systolic blood pressure was reported here. Final Assessment is the last valid assessment obtained after Baseline (Visit 2/Day 0) whilst on investigational product and before first dose taper medication [Visit 19/Early Termination (ET)/Day 714].|Baseline (Day 0) and Final Assessment (last non missing data/up to Day 714)|Safety Analysis Set includes all enrolled participants who took at least 1 dose of SPD503. Here, n = number of participants analysed for the specific categories for each arm respectively.||millimeter of mercury (mmHg)||Standard Deviation|Mean
685421|NCT01500629|Secondary|Change From Baseline of the Total Score From the Following Nasal Symptoms (TNSSX [Total Nasal Symptom Score Excluding Sneezing]): Itchy Nose, Runny Nose, Nasal Congestion at 1 Hour After the Second Allergen Challenge|TNSSX was derived by taking the sum of the average score of left and right nostrils for itchy nose, runny nose, and nasal congestion. Change from baseline of TNSSX was TNSSX for each post baseline time point minus its baseline. For the change from baseline of TNSSX, the total possible minimum value is 0 (best) and the total possible maximum value is 9 (worst).|within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||units on a scale||Standard Error|Mean
685422|NCT01500629|Secondary|Change From Baseline of the Total Score From the Following Nasal Symptoms (TNSSX [Total Nasal Symptom Score Excluding Sneezing]): Itchy Nose, Runny Nose, Nasal Congestion at 15 Minutes After the Second Allergen Challenge|TNSSX was derived by taking the sum of the average score of left and right nostrils for itchy nose, runny nose, and nasal congestion. Change from baseline of TNSSX was TNSSX for each post baseline time point minus its baseline. For the change from baseline of TNSSX, the total possible minimum value is 0 (best) and the total possible maximum value is 9 (worst).|within 15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||units on a scale||Standard Error|Mean
685423|NCT01500629|Secondary|Change From Baseline of the Total Score From the Following Nasal Symptoms (TNSSX [Total Nasal Symptom Score Excluding Sneezing]): Itchy Nose, Runny Nose, Nasal Congestion at 1 Hour After the First Allergen Challenge|TNSSX was derived by taking the sum of the average score of left and right nostrils for itchy nose, runny nose, and nasal congestion. Change from baseline of TNSSX was TNSSX for each post baseline time point minus its baseline. For the change from baseline of TNSSX, the total possible minimum value is 0 (best) and the total possible maximum value is 9 (worst).|within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||units on a scale||Standard Error|Mean
685425|NCT01500629|Secondary|Within Subject Improvement From Placebo in TNSS (Responder) at 1 Hour After the Second Allergen Challenge|A responder was defined as within subject improvement from placebo in TNSS with improvement from placebo based on the change from baseline for TNSS.|within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||participants|||Number
685426|NCT01500629|Secondary|Within Subject Improvement From Placebo in TNSS (Responder) at 15 Minutes After the Second Allergen Challenge|A responder was defined as within subject improvement from placebo in TNSS with improvement from placebo based on the change from baseline for TNSS.|within 15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||participants|||Number
685427|NCT01500629|Secondary|Within Subject Improvement From Placebo in TNSS (Responder) at 1 Hour After the First Allergen Challenge|A responder was defined as within subject improvement from placebo in TNSS with improvement from placebo based on the change from baseline for TNSS.|within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||participants|||Number
685428|NCT01500629|Secondary|Within Subject Improvement From Placebo in TNSS (Responder) at 15 Minutes After the First Allergen Challenge|A responder was defined as within subject improvement from placebo in TNSS with improvement from placebo based on the change from baseline for TNSS.|within 15 minutes|||participants|||Number
685429|NCT01500629|Secondary|Change From Baseline of Non Nasal Symptoms Score (NNSS) at 1 Hour After the Second Allergen Challenge|Subjects evaluated non nasal symptoms of itchy throat, ear, and palate using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of NNSS was calculated by taking the difference of the NNSS score for each post baseline time point minus its baseline. For the NNSS, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||units on a scale||Standard Error|Mean
685430|NCT01500629|Secondary|Change From Baseline of Non Nasal Symptoms Score (NNSS) at 15 Minutes After the Second Allergen Challenge|Subjects evaluated non nasal symptoms of itchy throat, ear, and palate using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of NNSS was calculated by taking the difference of the NNSS score for each post baseline time point minus its baseline. For the NNSS, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|within 15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||units on a scale||Standard Error|Mean
685431|NCT01500629|Secondary|Change From Baseline of Non Nasal Symptoms Score (NNSS) at 1 Hour After the First Allergen Challenge|Subjects evaluated non nasal symptoms of itchy throat, ear, and palate using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of NNSS was calculated by taking the difference of the NNSS score for each post baseline time point minus its baseline. For the NNSS, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||units on a scale||Standard Error|Mean
685432|NCT01500629|Secondary|Change From Baseline of Non Nasal Symptoms Score (NNSS) at 15 Minutes After the First Allergen Challenge|Subjects evaluated non nasal symptoms of itchy throat, ear, and palate using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of NNSS was calculated by taking the difference of the NNSS score for each post baseline time point minus its baseline. For the NNSS, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|within 15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||units on a scale||Standard Error|Mean
685433|NCT01500629|Secondary|Total Ocular Symptoms Score (TOSS) at 1 Hour After the Second Allergen Challenge|Subjects evaluated ocular symptoms of itchy eyes, watery eyes, and redness of eyes using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The TOSS was calculated by taking the sum of each average score (left and right eyes) for itchy eyes, watery eyes, and redness of eyes. For the TOSS, the total possible minimum value is 0 (best) and the total possible maximum value is 9 (worst).|within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||units on a scale||Standard Error|Mean
685434|NCT01500629|Secondary|Total Ocular Symptoms Score (TOSS) at 15 Minutes After the Second Allergen Challenge|Subjects evaluated ocular symptoms of itchy eyes, watery eyes, and redness of eyes using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The TOSS was calculated by taking the sum of each average score (left and right eyes) for itchy eyes, watery eyes, and redness of eyes. For the TOSS, the total possible minimum value is 0 (best) and the total possible maximum value is 9 (worst).|within 15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||units on a scale||Standard Error|Mean
685435|NCT01500629|Secondary|Total Ocular Symptoms Score (TOSS) at 1 Hour After the First Allergen Challenge|Subjects evaluated ocular symptoms of itchy eyes, watery eyes, and redness of eyes using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The TOSS was calculated by taking the sum of each average score (left and right eyes) for itchy eyes, watery eyes, and redness of eyes. For the TOSS, the total possible minimum value is 0 (best) and the total possible maximum value is 9 (worst).|within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||units on a scale||Standard Error|Mean
685436|NCT01500629|Secondary|Total Ocular Symptoms Score (TOSS) at 15 Minutes After the First Allergen Challenge|Subjects evaluated ocular symptoms of itchy eyes, watery eyes, and redness of eyes using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The TOSS was calculated by taking the sum of each average score (left and right eyes) for itchy eyes, watery eyes, and redness of eyes. For the TOSS, the total possible minimum value is 0 (best) and the total possible maximum value is 9 (worst).|within 15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||units on a scale||Standard Error|Mean
685469|NCT01500434|Secondary|Target Lesion Revascularization (TLR)|TLR is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
685437|NCT01500629|Secondary|Change From Baseline of Individual Nasal Symptoms Score (NSS) for Nasal Congestion at 1 Hour After the Second Allergen Challenge|Subjects evaluated the individual nasal symptom of nasal congestion using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for nasal congestion was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for nasal congestion, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||units on a scale||Standard Deviation|Mean
685438|NCT01500629|Secondary|Change From Baseline of Individual Nasal Symptoms Score (NSS) for Nasal Congestion at 15 Minutes After the Second Allergen Challenge|Subjects evaluated the individual nasal symptom of nasal congestion using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for nasal congestion was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for nasal congestion, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|within 15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||units on a scale||Standard Deviation|Mean
685439|NCT01500629|Secondary|Change From Baseline of Individual Nasal Symptoms Score (NSS) for Nasal Congestion at 1 Hour After the First Allergen Challenge|Subjects evaluated the individual nasal symptom of nasal congestion using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for nasal congestion was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for nasal congestion, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||units on a scale||Standard Deviation|Mean
685440|NCT01500629|Secondary|Change From Baseline of Individual Nasal Symptoms Score (NSS) for Nasal Congestion at 15 Minutes After the First Allergen Challenge|Subjects evaluated the individual nasal symptom of nasal congestion using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for nasal congestion was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for nasal congestion, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|within 15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||units on a scale||Standard Deviation|Mean
685441|NCT01500629|Secondary|Change From Baseline of Individual Nasal Symptoms Score (NSS) for Runny Nose at 1 Hour After the Second Allergen Challenge|Subjects evaluated the individual nasal symptom of runny nose using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for runny nose was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for runny nose, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||units on a scale||Standard Deviation|Mean
685442|NCT01500629|Secondary|Change From Baseline of Individual Nasal Symptoms Score (NSS) for Runny Nose at 15 Minutes After the Second Allergen Challenge|Subjects evaluated the individual nasal symptom of runny nose using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for runny nose was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for runny nose, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|within 15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||units on a scale||Standard Deviation|Mean
685443|NCT01500629|Secondary|Change From Baseline of Individual Nasal Symptoms Score (NSS) for Runny Nose at 1 Hour After the First Allergen Challenge|Subjects evaluated the individual nasal symptom of runny nose using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for runny nose was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for runny nose, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||units on a scale||Standard Deviation|Mean
685444|NCT01500629|Secondary|Change From Baseline of Individual Nasal Symptoms Score (NSS) for Runny Nose at 15 Minutes After the First Allergen Challenge|Subjects evaluated the individual nasal symptom of runny nose using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for runny nose was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for runny nose, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|Within 15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||units on a scale||Standard Deviation|Mean
685445|NCT01500629|Secondary|Change From Baseline of Individual Nasal Symptoms Score (NSS) for Itchy Nose at 1 Hour After the Second Allergen Challenge|Subjects evaluated the individual nasal symptom of itchy nose using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for itchy nose was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for itchy nose, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|Within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||units on a scale||Standard Deviation|Mean
685582|NCT01499810|Secondary|Change in Mean Daytime Diastolic BP||from baseline to 12 months|||mmHg||Standard Deviation|Mean
685583|NCT01499810|Secondary|Change in Mean Daytime Systolic BP||from baseline to 12 months|||mmHg||Standard Deviation|Mean
685446|NCT01500629|Secondary|Change From Baseline of Individual Nasal Symptoms Score (NSS) for Itchy Nose at 15 Minutes After the Second Allergen Challenge|Subjects evaluated the individual nasal symptom of itchy nose using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for itchy nose was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for itchy nose, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|Within 15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||units on a scale||Standard Deviation|Mean
685447|NCT01500629|Secondary|Change From Baseline of Individual Nasal Symptoms Score (NSS) for Itchy Nose at 1 Hour After the First Allergen Challenge|Subjects evaluated the individual nasal symptom of itchy nose using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for itchy nose was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for itchy nose, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||units on a scale||Standard Deviation|Mean
685448|NCT01500629|Secondary|Change From Baseline of Individual Nasal Symptoms Score (NSS) for Itchy Nose at 15 Minutes After the First Allergen Challenge|Subjects evaluated the individual nasal symptom of itchy nose using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for itchy nose was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for itchy nose, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|within 15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||units on a scale||Standard Deviation|Mean
685449|NCT01500629|Secondary|Change From Baseline of Individual Nasal Symptoms Score (NSS) for Sneezing at 1 Hour After the Second Allergen Challenge|Subjects evaluated the individual nasal symptom of sneezing using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for sneezing was then calculated by taking the score at the post baseline time point minus its baseline score. For the change from baseline in the individual NSS for sneezing, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||units on a scale||Standard Deviation|Mean
685450|NCT01500629|Secondary|Change From Baseline of Individual Nasal Symptoms Score (NSS) for Sneezing at 15 Minutes After the Second Allergen Challenge|Subjects evaluated the individual nasal symptom of sneezing using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for sneezing was then calculated by taking the score at the post baseline time point minus its baseline score. For the change from baseline in the individual NSS for sneezing, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|Within 15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||units on a scale||Standard Deviation|Mean
685451|NCT01500629|Secondary|Change From Baseline of Individual Nasal Symptoms Score (NSS) for Sneezing at 1 Hour After the First Allergen Challenge|Subjects evaluated the individual nasal symptom of sneezing using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for sneezing was then calculated by taking the score at the post baseline time point minus its baseline score. For the change from baseline in the individual NSS for sneezing, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|Within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||units on a scale||Standard Deviation|Mean
685452|NCT01500629|Secondary|Change From Baseline of Individual Nasal Symptoms Score (NSS) for Sneezing at 15 Minutes After the First Allergen Challenge|Subjects evaluated the individual nasal symptom of sneezing using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for sneezing was then calculated by taking the score at the post baseline time point minus its baseline score. For the change from baseline in the individual NSS for sneezing, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|Within 15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||units on a scale||Standard Deviation|Mean
685453|NCT01500629|Secondary|Change From Baseline in Number of Sneezes at 1 Hour After the Second Allergen Challenge|Change from baseline in number of sneezes|Within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||sneezes||Standard Deviation|Mean
685454|NCT01500629|Secondary|Change From Baseline in Number of Sneezes at 15 Minutes After the Second Allergen Challenge|Change from baseline in number of sneezes|Within 15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||sneezes||Standard Deviation|Mean
685455|NCT01500629|Secondary|Change From Baseline in Number of Sneezes at 1 Hour After the First Allergen Challenge|Change from baseline in number of sneezes|Within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||sneezes||Standard Deviation|Mean
685456|NCT01500629|Secondary|Change From Baseline in Number of Sneezes at 15 Minutes After the First Allergen Challenge|Change from baseline in number of sneezes|Within 15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||sneezes||Standard Deviation|Mean
685457|NCT01500629|Secondary|Change From Baseline in the Total Nasal Symptom Score (TNSS) at 1 Hour After the Second Allergen Challenge|The change from baseline in TNSS of sneezing, itchy nose, runny nose, and nasal congestion at 1 hour after the second allergen challenge. TNSS was the sum of the severity of sneezing and the average score (left and right nostrils) for each of the following: itchy nose, runny nose, and nasal congestion. Severity of sneezing, itchy nose, runny nose, and nasal congestion were evaluated using a 4-point categorical scale where 0 = no symptoms, 1 = mild, 2 = moderate, 3 = severe. For the change from baseline in TNSS, the total possible minimum value is 0 (best) and the total possible maximum value is 12 (worst).|Within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||units on a scale||Standard Error|Mean
685584|NCT01499810|Secondary|Change in Mean Daytime Diastolic BP||from baseline to 6 months|||mmHg||Standard Deviation|Mean
685458|NCT01500629|Secondary|Change From Baseline in the Total Nasal Symptom Score (TNSS) at 15 Minutes After the Second Allergen Challenge|The change from baseline in TNSS of sneezing, itchy nose, runny nose, and nasal congestion at 15 minutes after the second allergen challenge. TNSS was the sum of the severity of sneezing and the average score (left and right nostrils) for each of the following: itchy nose, runny nose, and nasal congestion. Severity of sneezing, itchy nose, runny nose, and nasal congestion were evaluated using a 4-point categorical scale where 0 = no symptoms, 1 = mild, 2 = moderate, 3 = severe. For the change from baseline in TNSS, the total possible minimum value is 0 (best) and the total possible maximum value is 12 (worst).|15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||units on a scale||Standard Deviation|Mean
685459|NCT01500629|Secondary|Change From Baseline in the Total Nasal Symptom Score (TNSS) at 1 Hour After the First Allergen Challenge|The change from baseline in TNSS of sneezing, itchy nose, runny nose, and nasal congestion at 1 hour after the first allergen challenge. TNSS was the sum of the severity of sneezing and the average score (left and right nostrils) for each of the following: itchy nose, runny nose, and nasal congestion. Severity of sneezing, itchy nose, runny nose, and nasal congestion were evaluated using a 4-point categorical scale where 0 = no symptoms, 1 = mild, 2 = moderate, 3 = severe. For the change from baseline in TNSS, the total possible minimum value is 0 (best) and the total possible maximum value is 12 (worst).|1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||units on a scale||Standard Error|Mean
685460|NCT01500629|Primary|Change From Baseline in the Total Nasal Symptom Score (TNSS) at 15 Minutes After the First Allergan Challenge|The change from baseline in TNSS of sneezing, itchy nose, runny nose, and nasal congestion at 15 minutes after the first allergen challenge. TNSS was the sum of the severity of sneezing and the average score (left and right nostrils) for each of the following: itchy nose, runny nose, and nasal congestion. Severity of sneezing, itchy nose, runny nose, and nasal congestion were evaluated using a 4-point categorical scale where 0 = no symptoms, 1 = mild, 2 = moderate, 3 = severe. For the change from baseline in TNSS, the total possible minimum value is 0 (best) and the total possible maximum value is 12 (worst).|15 minutes (±5 minutes)|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||units on a scale||Standard Error|Mean
685461|NCT01500434|Secondary|Clinical Procedural Success|Defined as mean lesion diameter stenosis <30% with visually assessed TIMI 3 flow and without the occurrence of in-hospital MI, TVR, or cardiac death|In hospital (average of 1-2 days post index procedure)|Analysis was intention to treat||percentage of participants|||Number
685462|NCT01500434|Secondary|Acute Technical Success|Defined as successful delivery and deployment of the study stent to the target vessel, without balloon rupture or stent embolization; expressed per stent|Index Procedure|Analysis was intention to treat||percentage of stents|stents||Number
685463|NCT01500434|Secondary|Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days)|31-365 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
685464|NCT01500434|Secondary|Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days)|>24 hours-30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
685465|NCT01500434|Secondary|Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days)|24 hours|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
685466|NCT01500434|Secondary|Target Vessel Revascularization (TVR)|TVR is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
685467|NCT01500434|Secondary|Target Vessel Revascularization (TVR)|TVR is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
685468|NCT01500434|Secondary|Target Vessel Revascularization (TVR)|TVR is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.|30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
685585|NCT01499810|Secondary|Change in Mean Daytime Systolic BP||from baseline to 6 months|||mmHg||Standard Deviation|Mean
685470|NCT01500434|Secondary|Target Lesion Revascularization (TLR)|TLR is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
685471|NCT01500434|Secondary|Target Lesion Revascularization (TLR)|TLR is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.|30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
685472|NCT01500434|Secondary|Myocardial Infarction (MI) Related to the Target Vessel|New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase-myoglobin band (CK-MB) or troponin >normal; if no new Q-waves total CK levels >3×normal (peri-percutaneous coronary intervention[PCI]) or >2×normal (spontaneous) with elevated CK-MB or troponin >3×normal (peri-PCI) or >2×normal (spontaneous) plus at least 1 of the following: ECG changes showing new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium or new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5×normal|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
685473|NCT01500434|Secondary|Myocardial Infarction (MI) Related to the Target Vessel|New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase-myoglobin band (CK-MB) or troponin >normal; if no new Q-waves total CK levels >3×normal (peri-percutaneous coronary intervention[PCI]) or >2×normal (spontaneous) with elevated CK-MB or troponin >3×normal (peri-PCI) or >2×normal (spontaneous) plus at least 1 of the following: ECG changes showing new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium or new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5×normal|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
685474|NCT01500434|Secondary|Myocardial Infarction (MI) Related to the Target Vessel|New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase-myoglobin band (CK-MB) or troponin >normal; if no new Q-waves total CK levels >3×normal (peri-percutaneous coronary intervention[PCI]) or >2×normal (spontaneous) with elevated CK-MB or troponin >3×normal (peri-PCI) or >2×normal (spontaneous) plus at least 1 of the following: ECG changes showing new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium or new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5×normal|30 Days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
685475|NCT01500434|Secondary|Cardiac Death Related to the Target Vessel|Cardiac death is defined as Death due to any of the following: acute MI; cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
685476|NCT01500434|Secondary|Cardiac Death Related to the Target Vessel|Cardiac death is defined as Death due to any of the following: acute MI; cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
685477|NCT01500434|Secondary|Cardiac Death Related to the Target Vessel|Cardiac death is defined as Death due to any of the following: acute MI; cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded|30 Days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
685478|NCT01500434|Secondary|All Cause Death||12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
685479|NCT01500434|Secondary|All Cause Death||6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
685480|NCT01500434|Secondary|All Cause Death||30 Days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
685481|NCT01500434|Secondary|Target Vessel Failure (TVF)|TVF is defined as any ischemia-driven revascularization of the target vessel, myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
685482|NCT01500434|Secondary|Target Vessel Failure (TVF)|TVF is defined as any ischemia-driven revascularization of the target vessel, myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
685483|NCT01500434|Secondary|Target Vessel Failure (TVF)|TVF is defined as any ischemia-driven revascularization of the target vessel, myocardial infarction (MI, Q-wave and non–Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.|30 Days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
685484|NCT01500434|Secondary|Target Lesion Failure (TLF)|TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel.|6 Months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
685485|NCT01500434|Secondary|Target Lesion Failure (TLF)|TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (MI, Q-wave and non–Q-wave) related to the target vessel, or cardiac death related to the target vessel.|30 Days|Analysis was intention to treat; all participants underwent clinical follow-up to provide the information needed for this endpoint.||percentage of participants|||Number
685486|NCT01500434|Primary|Target Lesion Failure (TLF)|Defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (MI, Q-wave and non–Q-wave) related to the target vessel, or cardiac death related to the target vessel.|12 months|The primary analysis set for comparison of the primary endpoint, 12-month TLF, to the predefined performance goal of 21.1% (based on historical TAXUS Express results) is the per-protocol analysis set. All enrolled participants who received a PROMUS Element stent are included in the per-protocol analysis set.||percentage of participants|||Number
685487|NCT01500382|Primary|Number of Participants Who Discontinued Use of Study Drug Due to an AE|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. The number of participants who discontinued study drug due to an AE were reported.|Up to 6 weeks (up to 3 weeks in Period 1 and up to 3 weeks in Period 2)|The AST population, which included all participants who received at least one dose of study drug, was used for the safety evaluation. AEs are reported/grouped by drug taken at the time and not by randomly assigned sequence.||Participants|||Number
685488|NCT01500382|Primary|Number of Participants Who Experienced an Adverse Event (AE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.|Up to 6 weeks (up to 3 weeks in Period 1 and up to 3 weeks in Period 2)|The All Subjects as Treated (AST) population, which included all participants who received at least one dose of study drug, was used for the safety evaluation. AEs are reported/grouped by drug taken at the time and not by randomly assigned sequence.||Participants|||Number
685489|NCT01500382|Secondary|Fold-change From Baseline in Volume of Urine at First Desire to Void Post-dose on Day 7|Filling cystometry procedures were performed pre-dose on Day 1 and post-dose on Day 7 in each treatment period. Individual values in fold-change from baseline and post-dose on Day 7 will be natural log-transformed and evaluated with a linear mixed effects model having period and treatment as fixed effects and participant as a random effect.|Baseline (pre-dose Day 1) and Day 7 (post-dose)|Study was terminated by the Sponsor prior to completion. No planned efficacy summaries or analyses were completed.|||||
685490|NCT01500382|Primary|Fold-change From Baseline in Maximum Cystometric Capacity Post-dose on Day 7|Filling cystometry procedures were performed pre-dose on Day 1 and post-dose on Day 7 in each treatment period. Individual values in fold-change from baseline and post-dose on Day 7 will be natural log-transformed and evaluated with a linear mixed effects model having period and treatment as fixed effects and participant as a random effect.|Baseline (pre-dose Day 1) and Day 7 (post-dose)|Study was terminated by the Sponsor prior to completion. No planned efficacy summaries or analyses were completed.|||||
685491|NCT01500317|Secondary|Ascending Colon Emptying (AC t1/2)|Ascending colon emptying t1/2 will be estimated by power exponential analysis of the proportionate emptying over time of counts from the colon. The primary data for this analysis will be the proportion of decay and depth-corrected counts in the ascending colon on the hourly scans on the first day of transit measurement and the 24 hour data.|Over the first 24 hours after ingestion of the radioisotopically labeled charcoal particles|||hours||Standard Deviation|Mean
685492|NCT01500317|Secondary|Colonic Filling at 6 Hours|Percent of the radio-labeled meal that reached the colon at 6 hours, indirectly reflecting small bowel transit time.|6 hours|||percentage of radio-labeled meal||Standard Deviation|Mean
685493|NCT01500317|Primary|Gastric Emptying Half-time (t1/2) at 24 Hours||24 hours|||minutes||Standard Deviation|Mean
685494|NCT01500317|Secondary|Colonic Geometric Center at 8 and 48 Hours|The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.|8 hours, 48 hours|||units on a scale||Standard Deviation|Mean
685495|NCT01500317|Primary|Colonic Transit, Geometric Center at 24 Hours|The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.|24 hours|||units on a scale||Standard Deviation|Mean
685496|NCT01500278|Secondary|Kaplan-Meier Estimates of Proportion of Subjects Who Discontinued After Response at Week 12|Response at Week 12 means that a subject had either a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) ≤ 3.2 at Week 12 or had a reduction of DAS28 [ESR] ≥ 1.2 from Baseline to Week 12. Kaplan-Meier Estimates of Proportion of Subjects Discontinued are presented per study week (days relative to Week 12 visit).|From Week 12 up to Week 104|Week 12 Responders were defined as those with DAS28(ESR) LDA (defined as DAS28[ESR] ≤3.2) or a DAS28(ESR) CFB reduction of ≥1.2 at Week 12.||proportion of subjects|||Number
685497|NCT01500278|Secondary|Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 104|HAQ-DI was derived based on the mean of individual scores in 8 categories of daily living actives (using 20 questions). Each question was scored 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do), and the total HAQ-DI was scored on the scale of 0-3 as well. Change from Baseline was computed as the value at Week 104 minus the Baseline value. A negative value in Change from Baseline indicates an improvement.|From Baseline to Week 104|The Full Analysis Set (FAS) consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement.||Units on a Scale||Standard Error|Least Squares Mean
685498|NCT01500278|Secondary|Percentage of Subjects With a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) ≤ 3.2 at Week 104, in Subjects Responding at Both Week 6 and Week 12|"DAS28 [ESR] was calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC), Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula: 0.56 x √ (TJC) + 0.28 x √ (SJC) + 0.70 x lognat (ESR) + 0.014 x Patient Global Assessment of Arthritis, where 28 joints were examined and a lower score indicates less disease activity.
The definition of Week 6/12 responders was DAS28[ESR] Low Disease Activity (LDA) (ie ≤ 3.2) or an improvement of ≥ 1.2 in DAS28[ESR] relative to Baseline."|Week 104|Week 12 Responders were defined as those with DAS28(ESR) LDA (defined as DAS28[ESR] ≤3.2) or a DAS28(ESR) CFB reduction of ≥1.2 at Week 12. Only subjects responding at both Week 6 and Week 12 are included in this analysis.||Percentage of subjects|||Number
685499|NCT01500278|Secondary|Percentage of Subjects Who Had a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) ≤ 3.2 at Week 12|DAS28 [ESR] was calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC), Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula: 0.56 x √ (TJC) + 0.28 x √ (SJC) + 0.70 x lognat (ESR) + 0.014 x Patient Global Assessment of Arthritis, where 28 joints were examined and a lower score indicates less disease activity.|Week 12|The Full Analysis Set (FAS) consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement.||Percentage of subjects|||Number
685500|NCT01500278|Secondary|Percentage of Subjects Who Had a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) ≤ 3.2 at Week 6|DAS28 [ESR] was calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC), Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula: 0.56 x √ (TJC) + 0.28 x √ (SJC) + 0.70 x lognat (ESR) + 0.014 x Patient Global Assessment of Arthritis, where 28 joints were examined and a lower score indicates less disease activity.|Week 6|The Full Analysis Set (FAS) consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement.||Percentage of subjects|||Number
685501|NCT01500278|Secondary|Percentage of Subjects Who Met the American College of Rheumatology 20 % (ACR20) Criteria at Week 6|Subjects who met the ACR20 criteria were those subjects with at least 20% improvement from Baseline for Tender Joint Count (TJC), Swollen Joint Count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS).|Week 6|The Full Analysis Set (FAS) consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement.||Percentage of subjects|||Number
685502|NCT01500278|Secondary|Percentage of Week 12 Responders Who Had a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) ≤ 3.2 at Week 104|"DAS28 [ESR] was calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC), Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula: 0.56 x √ (TJC) + 0.28 x √ (SJC) + 0.70 x lognat (ESR) + 0.014 x Patient Global Assessment of Arthritis, where 28 joints were examined and a lower score indicates less disease activity.
The definition of Week 12 responders was DAS28[ESR] Low Disease Activity (LDA) (ie ≤ 3.2) or an improvement of ≥ 1.2 in DAS28[ESR] relative to Baseline."|Week 104|Week 12 Responders were defined as those with DAS28(ESR) LDA (defined as DAS28[ESR] ≤3.2) or a DAS28(ESR) CFB reduction of ≥1.2 at Week 12.||Percentage of subjects|||Number
685503|NCT01500278|Primary|Percentage of Subjects Who Had a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) ≤ 3.2 at Week 104|DAS28 [ESR] was calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC), Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula: 0.56 x √ (TJC) + 0.28 x √ (SJC) + 0.70 x lognat (ESR) + 0.014 x Patient Global Assessment of Arthritis, where 28 joints were examined and a lower score indicates less disease activity.|Week 104|The Full Analysis Set (FAS) consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement.||Percentage of subjects|||Number
685504|NCT01500278|Primary|Percentage of Subjects Who Met the American College of Rheumatology 20 % (ACR20) Criteria at Week 12|Subjects who met the ACR20 criteria were those subjects with at least 20% improvement from Baseline for Tender Joint Count (TJC), Swollen Joint Count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS).|Week 12|The Full Analysis Set (FAS) consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement.||Percentage of subjects|||Number
685505|NCT01500252|Secondary|Number of Revision Surgeries|This measure examined the number of reoperation in the two groups of subjects|10 years|All participants were analyzed.||participants|||Number
685506|NCT01500252|Secondary|Change in WOMAC Osteoarthritis Index Stiffness Score From 5 Years Postoperative to 10 Years Postoperative|"This index assesses stiffness as reported by the patient. The WOMAC stiffness scale has a minimum value of 0 (worst stiffness) to a maximum value of 100 (no stiffness).
The change score was calculated by subtracting the five-year score from the 10 year score."|5 years postoperative to 10 years postoperative|||units on a scale||Standard Deviation|Mean
685586|NCT01499810|Secondary|Change in Echocardiographic Left Ventricular Mass||from baseline to 12 months|Number of participants assessed by EchoCG at 12 months||g||Standard Deviation|Mean
685507|NCT01500252|Secondary|Change in WOMAC Osteoarthritis Index Function Score From 5 Years Postoperative to 10 Years Postoperative|"This index assesses function as reported by the patient. The WOMAC function scale has a minimum value of 0 (worst pain) to a maximum value of 100 (no pain).
The change score was calculated by subtracting the five year score from the 10 year score."|5 years postoperative to 10 years postoperative|||units on a scale||Standard Deviation|Mean
685508|NCT01500252|Secondary|Change in WOMAC Osteoarthritis Index Pain Score From 5 Years Postoperative to 10 Years Postoperative|"This index assesses pain as reported by the patient. The WOMAC Pain scale has a minimum value of 0 (worst pain) to a maximum value of 100 (no pain).
The change score was calculated by subtracting the five year score from the 10 year score."|5 years postoperative to 10 years postoperative|Two subjects, one in the patellar retention group and one in the patellar resurfacing group missed too many responses on the WOMAC questionnaire and was not included in the analysis.||units on a scale||Standard Deviation|Mean
685509|NCT01500252|Primary|Change in WOMAC Osteoarthritis Index Stiffness Score From Preoperative to 5 Years Postoperative|"This is the change in the patients' perceived pain between preoperative and 5 years postoperative.
The WOMAC stiffness scale has a minimum value of 0 (maximal stiffness) to a maximum value of 100 (no stiffness).
The change score was calculated by subtracting the preoperative score from the five year score."|Preoperative to 5 years postoperative|One subject in the patellar retention group missed too many responses on the WOMAC questionnaire and was not included in the analysis.||units on a scale||Standard Deviation|Mean
685510|NCT01500252|Primary|Change in WOMAC Osteoarthritis Index Function Score From Preoperative to 5 Years Postoperative|"This measures the change in patients' reported function from preoperative to 5 years postoperative.
The WOMAC Function scale has a minimum value of 0 (worst function) to a maximum value of 100 (no functional limitations).
The change score was calculated by subtracting the preoperative score from the five year score."|Preoperative to 5 years postoperative|One subject in the patellar retention group missed too many responses on the WOMAC questionnaire and was not included in the analysis.||units on a scale||Standard Deviation|Mean
685511|NCT01500252|Secondary|Change in WOMAC Osteoarthritis Index Stiffness Score From Preoperative to 1 Year Postoperative|"This index assesses stiffness as reported by the patient. The WOMAC stiffness scale has a minimum value of 0 (worst stiffness) to a maximum value of 100 (no stiffness).
The change score was calculated by subtracting the preoperative score from the one year score."|Preoperative to 1 year postoperative|||units on a scale||Standard Deviation|Mean
685512|NCT01500252|Secondary|Change in WOMAC Osteoarthritis Index Function Score From Preoperative to 1-year Postoperative|"This index assesses function as reported by the patient. The WOMAC function scale has a minimum value of 0 (worst function) to a maximum value of 100 (no functional limitations).
The change score was calculated by subtracting the preoperative score from the one year score."|Preoperative to 1 year postoperative|Two subjects, one in the patellar retention group and one in the patellar resurfacing group missed too many responses on the WOMAC questionnaire and was not included in the analysis.||units on a scale||Standard Deviation|Mean
685513|NCT01500252|Secondary|Change in WOMAC Osteoarthritis Index Pain Score From Preoperative to 1 Year Postoperative|"This index assesses pain as reported by the patient. The WOMAC Pain scale has a minimum value of 0 (worst pain) to a maximum value of 100 (no pain).
The change score was calculated by subtracting the preoperative score from the one year score."|Preoperative to 1 year postoperative|Two subjects, one in the patellar retention group and one in the patellar resurfacing group missed too many responses on the WOMAC questionnaire and was not included in the analysis.||units on a scale||Standard Deviation|Mean
685514|NCT01500252|Primary|Change in Western Ontario MacMaster (WOMAC) Osteoarthritis Index Pain Score From Preoperative to 5 Years Postoperative|"This index assesses pain as reported by the patient. The WOMAC Pain scale has a minimum value of 0 (worst pain) to a maximum value of 100 (no pain).
The change score was calculated by subtracting the preoperative score from the five year score."|Preoperative to 5 years postoperative|One subject in the patellar retention group missed too many responses on the WOMAC questionnaire and was not included in the analysis.||units on a scale||Standard Deviation|Mean
685515|NCT01500226|Secondary|Overall Response Rate|To determine the effect of rolapitant on complete response rate in the overall (0 to 120 hours) phase of CINV.|0 to 120 hours|MITT||percentage of participants||95% Confidence Interval|Number
685516|NCT01500226|Secondary|Acute Phase Response|To determine the effect of rolapitant on complete response rates in the acute (0 to 24 hours) phase of CINV.|0 to 24 hours|MITT||percentage of participants||95% Confidence Interval|Number
685517|NCT01500226|Primary|No Emetic Episodes and No Rescue Medication|The primary objective of this study is to determine whether administration of rolapitant with granisetron and dexamethasone improves CINV in the delayed phase (>24 to 120 hours) of CINV compared with administration of placebo with granisetron and dexamethasone in subjects receiving MEC. The primary outcome will be based on complete response (defined as no emesis and no rescue medication) in the delayed phase (>24 to 120 hours).|>24 to 120 hours post chemotherapy|MITT||percentage of particpants||95% Confidence Interval|Number
685518|NCT01500213|Secondary|Overall Response Rate|To determine the effect of rolapitant on complete response rate in the overall (0 to 120 hours) phase of CINV.|0 to 120 hours|MITT||percentage of participants||95% Confidence Interval|Number
685519|NCT01500213|Secondary|Acute Phase Response|To determine the effect of rolapitant on complete response rates in the acute (0 to 24 hours) phase of CINV.|0 to 24 hours|MITT||percentage of participants||95% Confidence Interval|Number
685520|NCT01500213|Primary|No Emetic Episodes and No Rescue Medication|The primary objective of this study is to determine whether administration of rolapitant with granisetron and dexamethasone improves CINV in the delayed phase (>24 to 120 hours) of CINV compared with administration of placebo with granisetron and dexamethasone in subjects receiving HEC. The primary outcome will be based on complete response (defined as no emesis and no rescue medication) in the delayed phase (>24 to 120 hours).|>24 to 120 hours post chemotherapy|MITT||percentage of participants||95% Confidence Interval|Number
685521|NCT01500135|Secondary|Time to Intra-operative Hemostasis Within 10 Minutes at the Evaluation Site After Application of the Randomized Treatment|After application of Investigational Medicinal Product (IMP) light pressure was applied to the IMP with e.g. gauze pads. Hemostasis was assessed at 3, 4, and 5 minutes. If hemostasis was not obtained after 5 minutes a second application of IMP was applied with 3 minutes of light pressure and hemostasis was re-assessed at 8, 9 and 10 minutes.|Within 10 minutes|FAS included all randomized participants. Participants who did not achieve hemostasis by 10 minutes were censored.||minutes||95% Confidence Interval|Median
685522|NCT01500135|Secondary|Percentage of Participants With Intra-operative Hemostasis at the Evaluation Site Within 5 Minutes After Application of the Randomized Treatment|After application of Investigational Medicinal Product (IMP) light pressure was applied to the IMP with e.g. gauze pads. If hemostasis was not obtained at minute 3, pressure was immediately reapplied. Hemostasis was re-assessed at minutes 4 and 5.|Within 5 minutes|FAS included all randomized participants. The endpoint for one participant on TachoSil® was missing; it was assumed that hemostasis was not reached within 5 minutes.||percentage of participants||95% Confidence Interval|Number
685523|NCT01500135|Primary|Percentage of Participants With Intra-operative Hemostasis at the Evaluation Site Within 3 Minutes After Application of the Randomized Treatment|After application of Investigational Medicinal Product (IMP) light pressure was applied to the IMP with e.g. gauze pads. The first assessment of hemostasis was at minute 3: the pressure was carefully relieved, and the area was observed for visual bleeding at the site of the IMP. If no bleeding was visible, hemostasis was obtained and recorded.|Within 3 minutes|Full Analysis Set (FAS) included all randomized participants. The endpoint for one participant on TachoSil® was missing; it was assumed that hemostasis was not reached within 3 minutes.||percentage of participants||95% Confidence Interval|Number
685524|NCT01500109|Secondary|Pain Scores Using the Age-appropriate Pain Scale|The investigators will also be looking for the presence of pruritus, nausea, vomiting and/or sedation|24 hours||||||
685525|NCT01500109|Primary|Opioid (Fentanyl and Morphine) Consumption|The primary outcome measure of the study will be to measure opioid (Fentanyl and Morphine) consumption during the intraoperative period first postoperative 24 hours (measured in morphine equivalents).|intraoperative period and first postoperative 24 hours|||mcg•kg-1||95% Confidence Interval|Mean
685526|NCT01500083|Primary|Number of Adverse Events||Up to 266 days|APTS||number of adverse events|||Number
685527|NCT01500031|Other Pre-specified|OffRoad System Use Length of Time|"From time of positioning balloon catheter introduced in the body until time final OffRoad component removed."|On the day of Procedure|All subjects who signed and dated the written Informed Consent Form and had any part of the OffRoad System introduced into the body were included in the analysis. 1 participant was not evaluable (No data available).||minutes||Standard Deviation|Mean
685528|NCT01500031|Other Pre-specified|Overall Procedure Time|Defined as the time when the treating physician first punctures the skin in order to obtain access to the artery to treat the target lesion until the time the introducer sheath is removed from the body.|On the day of Procedure|All subjects who signed and dated the written Informed Consent Form and had any part of the OffRoad System introduced into the body were included in the analysis.||minutes||Standard Deviation|Mean
685529|NCT01500031|Other Pre-specified|Device-related Dissection, Grade C or Greater|"Type A- Small radiolucent area within the lumen of the vessel disappearing with the passage of the contrast material.
Type B- Appearance of contrast medium parallel to the lumen of the vessel disappearing within a few cardiac cycles.
Type C- Dissection protruding outside the lumen of the vessel persisting after passage of the contrast material.
Type D- Spiral shaped filling defect with or without delayed run-off of the contrast material in the antegrade flow.
Type E- Persistent luminal filling defect with delayed run-off of the contrast material in the distal lumen."|30 days|All subjects who signed and dated the written Informed Consent Form and had any part of the OffRoad System introduced into the body were included in the analysis. 2 participants were not evaluable (No follow-up ≥ 23 days and events-free within 30-day).||percentage of participants|||Number
685530|NCT01500031|Other Pre-specified|Target Lesion Revascularization Due to a Complication|Any surgical or percutaneous intervention to the target lesion(s) after the index procedure.|30 days|All subjects who signed and dated the written Informed Consent Form and had any part of the OffRoad System introduced into the body were included in the analysis. 2 participants were not evaluable (No follow-up ≥ 23 days and events-free within 30-day).||percentage of participants|||Number
685531|NCT01500031|Other Pre-specified|Acute Procedure Success|Acute Procedure Success, defined as device technical success and the absence of in-hospital Major Adverse Events {death, perforation requiring intervention, clinically significant peripheral embolism, and major amputation (amputation of the treated lower limb at the ankle level or above)}|30 days|All subjects who signed and dated the written Informed Consent Form and had any part of the OffRoad System introduced into the body were included in the analysis. 2 participants were not evaluable (No follow-up ≥ 23 days and events-free within 30-day).||percentage of participants|||Number
685532|NCT01500031|Other Pre-specified|All Adverse Events|All adverse events (AEs) reported by the centers.|30 days|All subjects who signed and dated the written Informed Consent Form and had any part of the OffRoad System introduced into the body were included in the analysis. 2 participants were not evaluable (No follow-up ≥ 23 days and events-free within 30-day).||adverse events|||Number
685533|NCT01500031|Other Pre-specified|Device-related Major Amputation at Ankle Level or Above of Treated Lower Limb|"All Major amputations related to the use of the OffRoad Re-entry Catheter System.
Events are based on site reported Adverse Event data."|30 days|All subjects who signed and dated the written Informed Consent Form and had any part of the OffRoad System introduced into the body were included in the analysis. 2 participants were not evaluable (No follow-up ≥ 23 days and events-free within 30-day).||percentage of participants|||Number
685534|NCT01500031|Other Pre-specified|Device-related Clinically Significant Peripheral Embolism|"All clinically significant peripheral embolisms related to the use of the OffRoad Re-entry Catheter System.
Events are based on site reported Adverse Event data."|30 days|All subjects who signed and dated the written Informed Consent Form and had any part of the OffRoad System introduced into the body were included in the analysis. 2 participants were not evaluable (No follow-up ≥ 23 days and events-free within 30-day).||percentage of participants|||Number
685535|NCT01500031|Other Pre-specified|Device-related Perforation Requiring Intervention|"All perforation requiring intervention related to the use of the OffRoad Re-entry Catheter System.
Events are based on site reported Adverse Event data."|30 days|All subjects who signed and dated the written Informed Consent Form and had any part of the OffRoad System introduced into the body were included in the analysis. 2 participants were not evaluable (No follow-up ≥ 23 days and events-free within 30-day).||percentage of participants|||Number
685587|NCT01499810|Secondary|Change in Echocardiographic Left Ventricular Mass||from baseline to 6 months|Number of participants assessed by echocardiography (EchoCG ) at 6 months||g||Standard Deviation|Mean
685536|NCT01500031|Other Pre-specified|Device-related Death|All death related to the use of the OffRoad Re-entry Catheter System. Events are based on site reported Adverse Event data.|30 days|All subjects who signed and dated the written Informed Consent Form and had any part of the OffRoad System introduced into the body were included in the analysis. 2 participants were not evaluable (No follow-up ≥ 23 days and events-free within 30-day).||percentage of participants|||Number
685537|NCT01500031|Primary|Effectiveness (On the Day of Procedure)|Device Technical Success rate, defined as placement of a guidewire in the true lumen distal to a Chronic Total Occlusion (CTO)|Device technical success is determined during the index procedure, from the time of first puncture of the skin in order to obtain access to the artery until the time the introducer sheath is removed from the body|The primary endpoints were analyzed on an intent-to-treat (ITT) basis. All subjects who signed and dated the written Informed Consent Form (ICF) and had any part of the OffRoad System introduced into the body were included in the ITT analysis.||percentage of participants||95% Confidence Interval|Number
685538|NCT01500031|Primary|Composite Rate of Major Adverse Events|"Composite rate of major adverse events (MAEs) related to the OffRoad System at 30 days, including: death, perforation requiring intervention, clinically significant peripheral embolism, and major amputation (amputation of the treated lower limb at the ankle level or above).
Events are based on data adjudicated by a Clinical Event Committee."|30 days|The primary endpoints were analyzed on an intent-to-treat (ITT) basis. All subjects who signed and dated the written Informed Consent Form (ICF) and had any part of the OffRoad System introduced into the body were included in the ITT analysis. 2 participants were not evaluable (No follow-up ≥ 23 days and events-free within 30-day)||percentage of participants|||Number
685539|NCT01499862|Primary|Ambulation Speed|Ambulation speed, in meters per second, as obtained by the Ten (10) Meter Walk Test (10 MWT). The 10 MWT measures the time required to walk 10 meters at the subject's comfortable walking pace.|Baseline (prior to training); at conclusion of 4 week training regimen (1.5 hours/session with 2 to 4 sessions per week); and 1 Month post-training regimen.|Three (3) Subjects all of whom had a plateaued with conventional Bodyweight-Supported Treadmill Training (BWSTT) participated in task-oriented mobility therapy (1.5 hours, 2-4 times per week for 4 weeks) with the Tibion Bionic Leg under the supervision of a physical therapist.||meters per second (m/s)|||Number
685540|NCT01499862|Secondary|Step Length|The length of the patient's average step, in meters, as measured during comfortable walking.|Baseline (prior to training); at conclusion of 4 week training regimen (1.5 hours/session with 2 to 4 sessions per week); and 1 Month post-training regimen.|Three (3) Subjects all of whom had a plateaued with conventional Bodyweight-Supported Treadmill Training (BWSTT) participated in task-oriented mobility therapy (1.5 hours, 2-4 times per week for 4 weeks) with the Tibion Bionic Leg under the supervision of a physical therapist.||Meters|||Number
685541|NCT01499862|Secondary|Five Times Sit to Stand Test (5 x STS)|The time, in seconds, for the patient to rise from a seated to full standing position and return to sitting five times in rapid succession. This evaluation is called the Five Times Sit to Stand Test (5 x STS)|Baseline (prior to training); at conclusion of 4 week training regimen (1.5 hours/session with 2 to 4 sessions per week); and 1 Month post-training regimen.|Three (3) Subjects all of whom had a plateaued with conventional Bodyweight-Supported Treadmill Training (BWSTT) participated in task-oriented mobility therapy (1.5 hours, 2-4 times per week for 4 weeks) with the Tibion Bionic Leg under the supervision of a physical therapist.||Seconds|||Number
685542|NCT01499862|Secondary|Timed Up and Go (TUG) Test|The time, in seconds, for the patient to rise from sitting in a standard arm chair, walk 3 meters, turn around, walk back to the chair, and sit down. This evaluation is called the Timed Up and Go test (TUG). The patient may wear their usual footwear and use any aids (canes, walkers, etc.) they typically employ for comfortable walking.|Baseline (prior to training); at conclusion of 4 week training regimen (1.5 hours/session with 2 to 4 sessions per week); and 1 Month post-training regimen.|Three (3) Subjects all of whom had a plateaued with conventional Bodyweight-Supported Treadmill Training (BWSTT) participated in task-oriented mobility therapy (1.5 hours, 2-4 times per week for 4 weeks) with the Tibion Bionic Leg under the supervision of a physical therapist.||Seconds|||Number
685543|NCT01499862|Secondary|6 Minute Walk Test (6 MWT)|The total distance walked by the patient, in meters, as obtained by the Six (6) Minute Walk Test (6 MWT). The 6 MWT is performed over level ground, using any walking aids (canes, walkers, etc.) the patient requires for comfortable walking.|Baseline (prior to training); at conclusion of 4 week training regimen (1.5 hours/session with 2 to 4 sessions per week); and 1 Month post-training regimen.|Three (3) Subjects all of whom had a plateaued with conventional Bodyweight-Supported Treadmill Training (BWSTT) participated in task-oriented mobility therapy (1.5 hours, 2-4 times per week for 4 weeks) with the Tibion Bionic Leg under the supervision of a physical therapist.||Meters|||Number
685544|NCT01499849|Secondary|Overall Response Rate|To determine the effect of rolapitant on complete response rates in the overall (0 to 120 hours) phase of CINV.|0 to 120 hours|MITT||percentage of participants||95% Confidence Interval|Number
685545|NCT01499849|Secondary|Acute Phase Response|To determine the effect of rolapitant on complete response rates in the acute (0 to 24 hours)phase of CINV|0 to 24 hours|MITT||percentage of participants||95% Confidence Interval|Number
685546|NCT01499849|Primary|No Emetic Episodes and No Rescue Medication|The primary objective of this study is to determine whether administration of rolapitant with granisetron and dexamethasone improves CINV in the delayed phase (>24 to 120 hours) of CINV compared with administration of placebo with granisetron and dexamethasone in subjects receiving HEC. The primary outcome will be based on complete response (defined as no emetic episodes and no rescue medication) in the delayed phase (>24 to 120 hours).|>24 to 120 hours post chemotherapy|MITT||percentage of participants||95% Confidence Interval|Number
685547|NCT01499810|Secondary|Change in Morning Surge of BP||from baseline to 6 months||||||
685548|NCT01499810|Secondary|Change in Morning Surge of BP||from baseline to 12 months||||||
685549|NCT01499810|Secondary|Change in Arterial Stiffness|Change of cardio-ankle vascular index(CAVI) assessed by vascular screening device VaSera VS1000|from baseline to 6 months||||||
685550|NCT01499810|Secondary|Change in Arterial Stiffness|Change of cardio-ankle vascular index(CAVI) assessed by vascular screening device VaSera VS1000 (name of the model)|from baseline to 12 months||||||
685551|NCT01499810|Secondary|Change in Ultrasound Intima Media Thickness of Carotid Artery||from baseline to 12 months||||||
685552|NCT01499810|Secondary|Change in Ultrasound Intima Media Thickness of Carotid Artery||from baseline to 6 months||||||
685553|NCT01499810|Secondary|Change in Resistive Index Measured by Renal Doppler Flowmetry in Right Main Renal Artery|Resistive index calculated as relative difference between assessed by ultrasound Doppler maximal and minimal blood flow velocities, i.e. absolute difference between maximal and minimal blood flow velocities divided by maximal flow velocity|from baseline to 12 months|||difference between ratios||Standard Deviation|Mean
685554|NCT01499810|Secondary|Change in Resistive Index Measured by Renal Doppler Flowmetry in Left Main Renal Artery|Resistive index calculated as relative difference between assessed by ultrasound Doppler maximal and minimal blood flow velocities, i.e. absolute difference between maximal and minimal blood flow velocities divided by maximal flow velocity|from baseline to 12 months|||difference between ratios||Standard Deviation|Mean
685555|NCT01499810|Secondary|Change in Renal Resistive Index Measured by Doppler Flowmetry in Right Main Renal Artery|Resistive index calculated as relative difference between assessed by ultrasound Doppler maximal and minimal blood flow velocities, i.e. absolute difference between maximal and minimal blood flow velocities divided by maximal flow velocity|from baseline to 6 months|||difference between two ratios||Standard Deviation|Mean
685556|NCT01499810|Secondary|Change in Renal Resistive Index Measured by Doppler Flowmetry in Left Main Renal Artery|Resistive index calculated as relative difference between assessed by ultrasound Doppler maximal and minimal blood flow velocities, i.e. absolute difference between maximal and minimal blood flow velocities divided by maximal flow velocity|from baseline to 6 months|||difference between two ratios||Standard Deviation|Mean
685557|NCT01499810|Secondary|Change in Specific Gravity of Urine|Change of specific gravity of morning urine sample|from baseline to 12 months|||no specific units||Standard Deviation|Mean
685558|NCT01499810|Secondary|Change in Specific Gravity of Urine|Change of specific gravity of morning urine sample|from baseline to 6 months|||no specific units||Standard Deviation|Mean
685559|NCT01499810|Secondary|Change in Specific Gravity of Urine|Change of specific gravity of morning urine sample|from baseline to 1 week|||no specific units||Standard Deviation|Mean
685560|NCT01499810|Secondary|Change in Casual Proteinuria|Change of protein concentration in morning urine sample|from baseline to 12 months|||g/l||Standard Deviation|Mean
685561|NCT01499810|Secondary|Change in Casual Proteinuria|Change of protein concentration in morning urine sample|from baseline to 6 months|||g/l||Standard Deviation|Mean
685562|NCT01499810|Secondary|Change in Casual Proteinuria|Change of protein concentration in morning urine sample|from baseline to 1 week|||g/l||Standard Deviation|Mean
685563|NCT01499810|Secondary|Change in Serum Creatinine||from baseline to 12 months|||micromol/l||Standard Deviation|Mean
685564|NCT01499810|Secondary|Change in Serum Creatinine||from baseline to 6 months|||micromol/l||Standard Deviation|Mean
685565|NCT01499810|Secondary|Change in Serum Creatinine||from baseline to 1 week|||micromol/l||Standard Deviation|Mean
685566|NCT01499810|Secondary|Change in Nighttime Diastolic BP Variability|daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring|from baseline to 6 months|||mmHg||Standard Deviation|Mean
685567|NCT01499810|Secondary|Change in Nighttime Systolic BP Variability|daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring|from baseline to 6 months|||mmHg||Standard Deviation|Mean
685568|NCT01499810|Secondary|Change in Daytime Diastolic BP Variability|daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring|from baseline to 6 months|||mmHg||Standard Deviation|Mean
685569|NCT01499810|Secondary|Change in Daytime Systolic BP Variability|daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring|from baseline to 6 months|||mmHg||Standard Deviation|Mean
685570|NCT01499810|Secondary|Change in Nighttime Diastolic BP Variability|daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring|from baseline to 12 months|||mmHg||Standard Deviation|Mean
685571|NCT01499810|Secondary|Change in Nighttime Systolic BP Variability|daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring|from baseline to 12 months|||mmHg||Standard Deviation|Mean
685572|NCT01499810|Secondary|Change in Daytime Diastolic BP Variability|daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring|from baseline to 12 months|||mmHg||Standard Error|Mean
685573|NCT01499810|Secondary|Change in Daytime Systolic BP Variability|daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring (ABPM)|from baseline to 12 months|||mmHg||Standard Error|Mean
685574|NCT01499810|Secondary|Change in Mean Nighttime Diastolic BP Dipping|Mean nighttime BP dipping is a relative difference: absolute difference between mean daytime and mean nighttime BP values divided by mean daytime BP value|from baseline to 12 months|||percentages||Standard Deviation|Mean
685575|NCT01499810|Secondary|Change in Mean Nighttime Systolic BP Dipping|Mean nighttime BP dipping is a relative difference: absolute difference between mean daytime and mean nighttime BP values divided by mean daytime BP value|from baseline to 12 months|||difference between percentages||Standard Deviation|Mean
685576|NCT01499810|Secondary|Change in Mean Nighttime Diastolic BP Dipping|Mean nighttime BP dipping is a relative difference: absolute difference between mean daytime and mean nighttime BP values divided by mean daytime BP value|from baseline to 6 months|||percentages||Standard Deviation|Mean
685577|NCT01499810|Secondary|Change in Mean Nighttime Systolic BP Dipping|Mean nighttime BP dipping is a relative difference: absolute difference between mean daytime and mean nighttime BP values divided by mean daytime BP value|from baseline to 6 months|||percentages||Standard Deviation|Mean
685578|NCT01499810|Secondary|Change in Mean Nighttime Diastolic BP||from baseline to 12 months|||mmHg||Standard Deviation|Mean
685579|NCT01499810|Secondary|Change in Mean Nighttime Systolic BP||from baseline to 12 months|||mmHg||Standard Deviation|Mean
685580|NCT01499810|Secondary|Change in Mean Nighttime Diastolic BP||from baseline to 6 months|||mmHg||Standard Deviation|Mean
685581|NCT01499810|Secondary|Change in Mean Nighttime Systolic BP||from baseline to 6 months|||mmHg||Standard Deviation|Mean
685595|NCT01499810|Primary|Number of Serious Adverse Events|A number of first occurrences (within the study period) of any of the following: death, end-stage renal disease, an embolic event resulting in end-organ damage, major bleeding event, renal artery thrombosis, new renal artery stenosis, other serious cardiovascular complications if their relation to the study treatment is assessed at least as possible.|from baseline to 12 months|||Events|||Number
685596|NCT01499810|Primary|Change in Office Systolic BP||from baseline to 12 months|All patients who completed 12 month assessment according to the protocol.||mmHg||Standard Deviation|Mean
685597|NCT01499667|Secondary|Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) and Death During Fingolimod Treatment|Adverse events were summarized by the number of patients having any adverse event overall.|Baseline to maximum of 16 weeks|The Safety Set included all randomized patients, analyzed according to the washout group most closely corresponding to the day on which they first received fingolimod||participants|||Number
685598|NCT01499667|Secondary|Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) and Death During Washout Period|Adverse events were summarized by the number of patients having any adverse event overall.|Baseline to maximum of 16 weeks|The Safety Set included all randomized patients, analyzed according to the washout group most closely corresponding to the day on which they first received fingolimod||participants|||Number
685599|NCT01499667|Secondary|Cumulative Number of Gadolinium-enhancing T1 Lesions From the Last Natalizumab Infusion|Gadolinium-enhancing lesions will be measured on post-contrast T1-weighted brain MRI scans|8 weeks and 24 weeks|The Full Analysis Set (FAS) included all randomized patients who had at least one recorded dose of natalizumab at the Week 0 visit, analyzed according to the washout group assigned at randomization.||Number of Gd enhanced T1 Lesions||Standard Deviation|Mean
685600|NCT01499667|Secondary|Change From Baseline in Expanded Disability Status Scale (EDSS) by Washout Group|Kurtzke’s Expanded Disability Status Scale (EDSS) measures the changes in neurologic impairment, either chronic (progression over time), or acute (MS relapses). The EDSS steps range from 0 (normal) to 10 (death due to MS). Relapse severity is assessed based on severity of neurologic impairment as evaluated using the EDSS.|Baseline to week 16 and week 32|The Full Analysis Set (FAS) included all randomized patients who had at least one recorded dose of natalizumab at the Week 0 visit, analyzed according to the washout group assigned at randomization.||Units on a scale||Standard Deviation|Mean
685601|NCT01499667|Secondary|Number of Active (New or Newly Enlarging) T2 Lesions During the 24 Weeks After the Last Natalizumab Infusion (Baseline)|Lesions will be measured by MRIs and the number of active (new or newly enlarging) T2 lesions will be calculated for 24 weeks from baseline.|Baseline up to 24 weeks|The Full Analysis Set (FAS) included all randomized patients who had at least one recorded dose of natalizumab at the Week 0 visit, analyzed according to the washout group assigned at randomization||Count of Active T2 Lesions||Standard Deviation|Mean
685602|NCT01499667|Secondary|Number of Active (New or Newly Enlarging) T2 Lesions During the First 8 Weeks of Fingolimod Treatment|Lesions were measured by MRIs and the number of active (new or newly enlarging) T2 lesions was calculated for first 8 weeks of fingolimod treatment.|Number of active T2 lesions during 8 wks of fingolimod treatment|The Full Analysis Set (FAS) included all randomized patients who had at least one recorded dose of natalizumab at the Week 0 visit, analyzed according to the washout group assigned at randomization||Count of Active T2 Lesions||Standard Deviation|Mean
685603|NCT01499667|Secondary|Number of Active (New or Newly Enlarging) T2 Lesions From the Last Natalizumab Infusion (Baseline) up to the Initiation of Fingolimod Treatment|Lesions were measured by MRIs and the number of active (new or newly enlarging) T2 lesions was calculated from baseline to beginning of treatment.|8, 12 and 16 weeks (number of active T2 lesions during the washout period only)|The Full Analysis Set (FAS) included all randomized patients who had at least one recorded dose of natalizumab at the Week 0 visit, analyzed according to the washout group assigned at randomization||Count of active T2 lesions||Standard Deviation|Mean
685604|NCT01499667|Primary|Number of Active (New or Newly Enlarging) T2 Lesions From the Last Natalizumab Infusion (Baseline) Through 8 Weeks of Fingolimod Treatment|Active lesions were measured on brain MRI scans, performed at week 8, compared to the prior scan. The primary variable was analyzed by fitting a negative binomial regression model adjusted for washout group.|Number of active T2 lesions from last natalizumab dose through 8 weeks of fingolimod treatment|The modified Full Analysis Set (mFAS) included all patients in the Full Analysis Set who completed 8 weeks of fingolimod treatment and provided an MRI scan at this time point. The analysis of primary variable was performed on the mFAS.||Count of Active T2 Lesions||Standard Deviation|Mean
685605|NCT01499654|Post-Hoc|Injection and Scan Times|Time in minutes between doses of resting Tc-99m sestamibi doses and image scanning.|Baseline|||minutes||Standard Deviation|Mean
685606|NCT01499654|Post-Hoc|Resting Full-Tracer Dose|Amount of the standard, clinically-accepted, full-dose Tc-99m sestamibi dose administered|Baseline|Entire Cohort||millicurie||Standard Deviation|Mean
685607|NCT01499654|Primary|Segments With Resting Perfusion Defect|Left ventricular myocardium was divided into standardized 17-segments with 6 equiangular segments in the basal region, 6 equiangular segments in the mid region, 4 equiangular segments in the apical regions, and 1 region in the apex (Cerqueira MD, et al., J Nucl Cardiol 2002;9:240-5). Each segment was scored on a scale from 0 to 4 to indicate the severity of the perfusion defect (0=no perfusion defect; 1=mild perfusion defect; 2=moderate perfusion defect; 3=severe perfusion defect; and 4=absent perfusion). The number of segments with a score of 1 or greater were summed to obtain the number of segments with a resting perfusion defect.|Baseline|||segments||Standard Deviation|Mean
685608|NCT01499654|Secondary|Diagnostic Confidence Score|Each reconstructed image was subjectively scored by the expert readers to determine the expert reader's diagnostic confidence in scoring and interpreting the perfusion scores. The Diagnostic Confidence Score of the reconstructed images were graded on a 4-point scale. (1=Poor; 2=Fair; 3=Good; and 4=Excellent).|Baseline|||units on a scale||Standard Deviation|Mean
685609|NCT01499654|Secondary|Image Quality Score|Each reconstructed image was subjectively scored by the expert readers to determine the overall image quality. The Image Quality Score of the reconstructed images were graded on a 4-point scale. (1=Poor; 2=Fair; 3=Good; and 4=Excellent).|Baseline|||units on a scale||Standard Deviation|Mean
685805|NCT01497665|Secondary|Duration of Overall Objective Response||Upon enrollment through end of study period (1 year after last patient is enrolled)|Once the study was terminated, no further data on response was collected and there was insufficient number of participants with data collected for this outcome measure.|||||
685610|NCT01499654|Primary|Sum Rest Score|Left ventricular myocardium was divided into standardized 17-segments with 6 equiangular segments in the basal region, 6 equiangular segments in the mid region, 4 equiangular segments in the apical regions, and 1 region in the apex (Cerqueira MD, et al., J Nucl Cardiol 2002;9:240-5). Each segment was scored on a scale from 0 to 4 to indicate the severity of the perfusion defect (0=no perfusion defect; 1=mild perfusion defect; 2=moderate perfusion defect; 3=severe perfusion defect; and 4=absent perfusion). The scores over 17 segments were summed to report the Sum Rest Score (SRS), ie. the greater the SRS, the larger the perfusion defect.|Baseline|||units on a scale||Standard Deviation|Mean
685611|NCT01499576|Secondary|Number of Participants With Adverse Events|Number of Participants with Adverse Events. Assess kind of side effect and severity. Measured by interview with a physician, just after the procedure and 1weak later.|up to 1week after the acetic acid chromoendoscopy|||participants|||Number
685612|NCT01499576|Secondary|Agreement of Acetic Acid Chromoendoscopic Reading Between the Two Endoscopists|"The findings of chromoendoscopy will be interpretated by two endoscoipists (read as positive or negative finding) independently.
We calculate the Kappa index of agreement for the acetic acid chromoendoscopy."|One month after the completion of the study|||Kappa index of agreement|Participants||Number
685613|NCT01499576|Primary|Percent Agreement Between Acetic Acid Chromoendoscopy and Endoscopic Biopsy|Endoscopist judges the presence and the extent of gastric intestinal metaplasia during acetic acid chromoendoscopy. Endoscopist perform five endoscopic biopsies according to the protocol. The degree of agreement between the chromoendoscopy and the endoscopic biopsy is assessed as %.|3 months after the completion of the study (a pathologist reviewed all the biopsy slide)|||percentage of lesions|Participants||Number
685614|NCT01499498|Secondary|Number of Patients With Adverse Events|The number of repeated adverse events will be used to assess the safety of the drugs in combination|Day 1 - 16|||participants|||Number
685615|NCT01499498|Primary|Boceprevir Maximum Plasma Concentration|administer BOC 800mg and single dose sildenafil 25mg with food. Intensive pharmacokinetic sampling will be taken over a 24 hour period (0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post dose)|Day 16|||ng/mL||95% Confidence Interval|Geometric Mean
685616|NCT01499498|Primary|Sildenafil Maximum Plasma Concentration|administer BOC 800mg and single dose sildenafil 25mg with food. Intensive pharmacokinetic sampling will be taken over a 24 hour period (0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post dose)|Day 16|||ng/mL||95% Confidence Interval|Geometric Mean
685617|NCT01499498|Primary|Boceprevir Alone Maximum Plasma Concentration|Day 10 commence BOC 800mg three times a day with food. On day 15 at steady state, subjects will attend for witnessed dosing and an intensive pharmacokinetic visit over 8 hours (samples drawn 0, 0.5, 1, 2, 3, 4, 6 and 8 hours post dose)|day 10-15|||ng/mL||95% Confidence Interval|Geometric Mean
685618|NCT01499498|Primary|Sildenafil Alone Maximum Plasma Concentration|Single dose sildenafil 25mg will be administered with food. Intensive pharmacokinetic sampling will be taken over a 24 hour period (0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post dose)|Day 1|||ng/mL||95% Confidence Interval|Geometric Mean
685619|NCT01499355|Secondary|Duration of Renal Response in Participants Who Achieve Partial or Complete Renal Response at Any Time During the Study|Number of days between first visit with response to last consecutive visit with partial or complete response. Complete renal response is defined as: (1) uPCR <0.5 mg/mg with ≥ 50% reduction of uPCR from Day 1 (Baseline) (from a 24 hour urine collection); and (2) eGFR within normal range. Partial renal response is defined as: (1) ≥ 50% reduction in uPCR from Day 1 (Baseline; from a 24-hour urine collection) and, (2) with one of the following: (a) uPCR of < 1.0 mg/mg if the Day 1 (Baseline) was ≤ 3.0 mg/mg, or, (b) uPCR < 3.0 mg/mg if the Day 1 (Baseline) ratio was > 3.0 mg/mg; and stabilization of renal function (eGFR + or - 25% of Day 1 [Baseline] or serum creatinine within normal range). Estimated from the Kaplan-Meier Curve.|up to Week 52|The ITT population included all participants who were randomized and received at least 1 dose of study treatment (BIIB023 or placebo).||days||Standard Deviation|Mean
685620|NCT01499355|Secondary|Number of Participants With AEs, SAEs and AEs Leading to Study Discontinuation During the Double-Blind Period|AEs that had an onset on or after dosing of BIIB023 or placebo, or any pre-existing condition that worsened. AE: any untoward medical occurrence that does not necessarily have a causal relationship with this treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect. An SAE may also be any other medically important event that, in the opinion of the Investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed above.|Week 12 to Week 56|The safety population was defined as all subjects who received at least 1 dose of study treatment (including placebo or BIIB023).||participants|||Number
685621|NCT01499355|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Study Discontinuation During the Run-In Period|AEs that had an onset on or after dosing of MMF on run-in Day 1 up to the first double-blind dose, or any pre-existing condition that worsened. AE: any untoward medical occurrence that does not necessarily have a causal relationship with this treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect. An SAE may also be any other medically important event that, in the opinion of the Investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed above.|Day 1 to Week 12|All enrolled participants||participants|||Number
685639|NCT01499290|Primary|Clinical Response at the TOC Visit in the Clinically Evaulable (CE) Analysis Set (Co-primary Outcome for Rest of World [ROW]).|The number of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.|TOC: 28 to 35 days after start of study drug|The CE analysis set included all patients who met the disease definition of cIAI and met the stringent criteria for clinical evaluation described in the protocol regarding dosing, concomitant medication, evaluation, etc.||Participants|||Number
685806|NCT01497665|Secondary|Number of Patients With Adverse Events as a Measure of Safety and Tolerability||Upon enrollment through end of study period (1 year after last patient is enrolled)|||participants|||Number
685622|NCT01499355|Secondary|Percentage of Participants With Active Urinary Sediment at Baseline Who Have Inactive Urinary Sediment at Week 52|Active urinary sediment is defined by 1 of the following (in the absence of a urinary tract infection or menses): > 5 red blood cell/high power field (RBC/HPF) or above the reference range for the laboratory, and > 5 white blood cell/high power field (WBC/HPF) or above the reference range for the laboratory, and presence of cellular casts (RBC or WBC). Inactive urinary sediment is defined as: < 5 RBC/HPF and < 5 WBC/HPF, or within the laboratory reference range, and no cellular casts (no RBC or WBC casts).|Baseline, Week 52|Participants with active urinary sediment at Day 1 in the mITT population (participants in ITT population except for those who withdrew from study due to study early termination. (Includes participants who completed Week 44 infusion and Visits at Week 52/Early Withdrawal and Week 56/End of Study but withdrew due to study early termination.)||percentage of participants||90% Confidence Interval|Number
685623|NCT01499355|Secondary|Percentage of Participants With uPCR > 3.0 mg/mg at Baseline Who Achieve uPCR <1.0 mg/mg at Week 52||Baseline (Day 1), Week 52|Participants with a uPCR > 3.0 mg/mg at Baseline in the mITT population (participants in ITT population except for those who withdrew from study due to study early termination. Includes those who completed Week 44 infusion and Visits at Week 52/Early Withdrawal and Week 56/End of Study but withdrew due to study early termination.)||percentage of participants||90% Confidence Interval|Number
685624|NCT01499355|Secondary|Time to Renal Response (Partial or Complete) in Participants Who Achieve Renal Response at Week 52|Onset of renal response was calculated as weeks elapsed from baseline date to first visit where renal response was achieved. Complete renal response is defined as: (1) uPCR <0.5 mg/mg with ≥ 50% reduction of uPCR from Day 1 (Baseline) (from a 24 hour urine collection); and (2) eGFR within normal range. Partial renal response is defined as: (1) ≥ 50% reduction in uPCR from Day 1 (Baseline; from a 24-hour urine collection) and, (2) with one of the following: (a) uPCR of < 1.0 mg/mg if the Day 1 (Baseline) was ≤ 3.0 mg/mg, or, (b) uPCR < 3.0 mg/mg if the Day 1 (Baseline) ratio was > 3.0 mg/mg; and stabilization of renal function (eGFR + or - 25% of Day 1 [Baseline] or serum creatinine within normal range). Estimated from the Kaplan-Meier Curve.|Baseline to Week 52|Participants in the ITT population who achieved a renal response at Week 52. The ITT population included all participants who were randomized and received at least 1 dose of study treatment (BIIB023 or placebo).||weeks||Full Range|Median
685625|NCT01499355|Secondary|Duration of Renal Response in Participants Who Achieve Complete Renal Response at Week 52|Duration of response was calculated as the days in between the date of Week 52 visit and the date when the participant last became complete renal responder on or before Week 52 visit. Complete renal response: (1) uPCR <0.5 mg/mg with ≥ 50% reduction of uPCR from Day 1 (Baseline) (from a 24 hour urine collection); and (2) eGFR within normal range.|Week 52|Participants in the mITT population (participants in ITT population except for those who withdrew from study due to study early termination. (Includes participants who completed Week 44 infusion and Visits at Week 52/Early Withdrawal and Week 56/End of Study but withdrew due to study early termination.)||Participants|||Count of Participants
685626|NCT01499355|Secondary|Percentage of Participants Who Achieve Complete Renal Response at Week 52|Complete renal response is defined as uPCR < 0.5 mg/mg with ≥ 50% reduction of uPCR from Baseline (from a 24-hour urine collection) and eGFR within normal range.|Week 52|Participants in the mITT population (participants in ITT population except for those who withdrew from study due to study early termination. Includes participants who completed Week 44 infusion and Visits at Week 52/early withdrawal and Week 56/End of Study but withdrew due to study early termination.)||percentage of participants|||Number
685627|NCT01499355|Primary|Percentage of Participants Who Achieve a Complete or Partial Renal Response at Week 52|Complete renal response is defined as: (1) urinary protein:creatinine ratio (uPCR) < 0.5 mg/mg with ≥ 50% reduction of uPCR from Day 1 (Baseline; from a 24 hour urine collection); and (2) estimated glomerular filtration rate (eGFR) within normal range. Partial renal response is defined as: (1) ≥ 50% reduction in uPCR from Day 1 (Baseline; from a 24-hour urine collection) and, (2) with one of the following: (a) uPCR of < 1.0 mg/mg if the Day 1 (Baseline) was ≤ 3.0 mg/mg, or, (b) uPCR < 3.0 mg/mg if the Day 1 (Baseline) ratio was > 3.0 mg/mg; and stabilization of renal function (eGFR + or - 25% of Day 1 [Baseline] or serum creatinine within normal range).|Week 52|Participants in the modified intent-to-treat (mITT) population (participants in ITT population except for those who withdrew from study due to study early termination. Includes participants who completed Week 44 infusion and Visits at Week 52/Early Withdrawal and Week 56/End of Study but withdrew due to study early termination.)||percentage of participants||90% Confidence Interval|Number
685628|NCT01499303|Primary|Objective Response Rate|Patients were assessed using the revised response criteria for malignant lymphoma (Cheson). Patients were assessed for response, with CT and FDG-PET scans at 8 weeks, then every 12 weeks until radiological progression by clinical CT. Complete response (CR) was defined as disappearance of all target and non-target lesions in the liver and spleen and all lymph node masses regressed to normal size. Partial response (PR) was defined as ≥50% reduction in sum of the product of the diameters (SPD) for measured lymph nodes, splenic and liver lesions separately compared to baseline SPD. Objective response rate (CR + PR) analysis, exact binomial test, primary analysis.|Week 8|Full analysis set - all randomised patients||Patients||95% Confidence Interval|Number
685629|NCT01499290|Secondary|Plasma Concentrations for Ceftazidime and Avibactam|Blood samples were taken from all patients on Day 3 for the pharmacokinetic evaluation of ceftazidime and avibactam plasma concentrations|Anytime within 15 minutes prior to or after stopping study drug, anytime between 30 and 90 minutes after stopping study drug, anytime between 300 minutes and 360 minutes after stopping study drug|PK analysis set||(NG/ML)||Full Range|Geometric Mean
685630|NCT01499290|Secondary|Number of Patients Afebrile at Last Observation in the Clinically Evaluable Analysis Set for Patients Who Have Fever at Study Entry|Time to first defervescence was calculated for patients with a fever (>38ºC) at baseline. Defervescence (≤37.8ºC) was defined as the absence of fever based on the highest temperature recorded on each study day.|Test of Cure: 1 to 14 days after start of study drug|Clinically evaluable (CE) with fever, defined as >38ºC at study entry.||Participants|||Number
685663|NCT01499199|Primary|Plasma DTG Unbound Fraction at Week 2 and Week 16|The unbound fraction of DTG in plasma (presented as a percentage of unbound [i.e., free DTG not bound to cellular proteins] DTG plasma concentration over paired plasma total DTG concentration) was calculated at the Week 2 and Week 16 visits.|Week 2 and Week 16|Plasma DTG Concentration Population||Percentage||Full Range|Median
685631|NCT01499290|Secondary|Per-patient Microbiological Response at TOC for Patients Infected With Ceftazidime-resistant Pathogens in mMITT Analysis Set|Microbiological responses other than “indeterminate” were classified as “favorable” or “unfavorable.” Favorable microbiological response assessments included “eradication” and “presumed eradication.” Unfavorable microbiological response assessments included “persistence,” “persistence with increasing minimum inhibitory concentration (MIC),” and “presumed persistence.” Indeterminate microbiologic response assessments included cases where the clinical response was changed to indeterminate due to an SRP assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).|Test of Cure: 28 to 35 days after start of study drug|The mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.||Participants|||Number
685632|NCT01499290|Secondary|Favorable Per-pathogen Microbiological Response for Patients Infected With Ceftazidime-resistant Pathogens in mMITT Analysis Set|The number of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.|TOC: 28 to 35 days after start of study drug|The mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.||Participants|||Number
685633|NCT01499290|Secondary|Clinical Response by Pathogen at TOC for Patients Infected With Ceftazidime-resistant Pathogens in Microbiological Modified Intent to Treat Analysis Set|Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.|Test of Cure: 28 to 35 days after start of study drug|The mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.||Participants|||Number
685634|NCT01499290|Secondary|Per-pathogen Microbiological Response at TOC in the Microbiologically Modified Intent-To-Treat Analysis Set.|The number of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.|TOC: 28 to 35 days after start of study drug.|The mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.||Participants|||Number
685635|NCT01499290|Secondary|Per-patient Microbiological Response in the Microbiologically Modified Intent- To-Treat Analysis Set|Microbiological responses as per the protocoled criteria: responses other than “indeterminate” were classified as “favorable” or “unfavorable.” Favorable microbiological response assessments included “eradication” and “presumed eradication.” Unfavorable microbiological response assessments included “persistence,” “persistence with increasing minimum inhibitory concentration (MIC),” and “presumed persistence.” Indeterminate microbiologic response assessments included cases where the clinical response was changed to indeterminate due to a surgical review panel (SRP) assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).|EOT: within 24 hours after last dose of study drug. TOC: 28 to 35 days after start of study drug. LFU 42 to 49 days after start of study drug|The mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.||Participants|||Number
685636|NCT01499290|Secondary|Clinical Response by Visit in the Primary Population: Microbiologically Modified Intent-to-Treat (mMITT)|Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary. Indeterminate response are where study data were not available for evaluation of efficacy for any reason, including patient lost to follow-up or assessment not undertaken such that a determination of clinical response could not be made, dDeath where cIAI was clearly noncontributory or circumstances that precluded classification as a cure or failure.|EOT: within 24 hours after last dose of study drug. TOC: 28 to 35 days after start of study drug. LFU: 42 to 49 days after start of study drug|The mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.||Participants|||Number
685637|NCT01499290|Secondary|Clinical Cure at TOC in the Extended Microbiologically Evaluable Analysis Set|The number of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.|TOC: 28 to 35 days after start of study drug|Extended ME analysis set defined as all patients included in the CE set with at least 1 Gram negative, aerobic, pathogen in the initial/prestudy culture, regardless of susceptibility.||Participants|||Number
685638|NCT01499290|Secondary|Clinical Cure at TOC in the Microbiologically Evaluable Analysis Set|The number of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.|TOC: 28 to 35 days after start of study drug|ME analysis set defined as all patients included in the CE set with at least 1 Gram negative, aerobic, susceptible pathogen in the initial/prestudy culture.||Participants|||Number
685664|NCT01499199|Primary|Unbound DTG Plasma Concentrations at Week 2 and Week 16|Unbound (free, not bound to cellular proteins) plasma DTG concentrations were calculated at the Week 2 and Week 16 visits.|Week 2 and Week 16|Plasma DTG Concentration Population||Nanograms per milliliter (ng/mL)||Full Range|Median
685640|NCT01499290|Primary|Clinical Response at the TOC Visit in the Modified Intent-To-Treat Analysis Set (Co-primary Outcome for Rest of World [ROW]).|The number of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary. Indeterminate response are where study data were not available for evaluation of efficacy for any reason, including patient lost to follow-up or assessment not undertaken such that a determination of clinical response could not be made, dDeath where cIAI was clearly noncontributory or circumstances that precluded classification as a cure or failure.|TOC: 28 to 35 days after start of study drug|The MITT analysis set included all randomized patients who met the disease definition of cIAI and who received any amount of study drug.||Participants|||Number
685641|NCT01499290|Primary|Clinical Response at the Test of Cure (TOC) Visit in the Microbiologically Modified Intent-To-Treat (mMITT) Analysis Set (Primary Outcome for FDA).|The number of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention is necessary. Indeterminate response are where study data were not available for evaluation of efficacy for any reason, including patient lost to follow-up or assessment not undertaken such that a determination of clinical response could not be made, death where cIAI was clearly noncontributory or circumstances that precluded classification as a cure or failure. Results from two identical protocols D4280C00001 and D4280C00005 combined into a single database with agreement from FDA and EMA.|TOC: 28 to 35 days after start of study drug|The mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.||Participants|||Number
685642|NCT01499277|Secondary|Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME|Per-pathogen microbiological response at TOC by baseline pathogen from site of skin infection in ME analysis set|7 to 20 days after the last dose of study drug|||Participants|||Number
685643|NCT01499277|Secondary|Early Response at 48 to 72 Hours of Treatment in MITT Analysis Set|The observed difference in the early success rates at 48 to 72 hours of treatment (ceftaroline group minus vancomycin plus aztreonam group) in MITT. Early response rate as measured by comparing the participant's signs and symptoms at the 48-72 hour visit to those recorded at study baseline.|48 to 72 hours after first dose of study drug|||Participants|||Number
685644|NCT01499277|Secondary|Clinical Relapse at Late Follow-up (LFU) in CE Patients Who Were Cured at TOC|The observed difference in the clinical relapse rates at LFU (ceftaroline group minus vancomycin plus aztreonam group) in CE. Clinical relapse rate at LFU is measured by comparing a patient's signs and symptoms at late follow-up to those when they were cured at TOC.|21 to 42 days after the last dose of study drug|||Participants|||Number
685645|NCT01499277|Secondary|Clinical Response at EOT in CE Analysis Set|The observed difference in the clinical cure rates at EOT (ceftaroline group minus vancomycin plus aztreonam group) in CE. Clinical cure rate is measured by comparing the participant’s signs and symptoms at EOT visit to those recorded at study baseline.|On day of last dose of study drug (or +1 day)|||Participants|||Number
685646|NCT01499277|Secondary|Clinical Response at End of Treatment (EOT) in MITT Analysis Set|The observed difference in the clinical cure rates at EOT (ceftaroline group minus vancomycin plus aztreonam group) in MITT. Clinical cure rate is measured by comparing the participant’s signs and symptoms at EOT visit to those recorded at study baseline.|On day of last dose of study drug (or + 1 day)|||Participants|||Number
685647|NCT01499277|Secondary|Per-patient Micro Response at TOC in Microbiologically Evaluable (ME) Analysis Set|Difference in microbiological favorable response rate at TOC in ME. Favourable microbiological response rate is measured by comparing TOC microbiological data to baseline microbiological data. In the absence of TOC microbiological data it is presumed from the clinical response.|7 to 20 days after the last dose of study drug|Microbiologically evaluable (ME)||Participant|||Number
685648|NCT01499277|Secondary|Per Patient Microbiological Response at TOC in Microbiologically Modified-intent-to-treat (mMITT) Analysis Set|Difference in microbiological favorable response rate at TOC in mMITT analysis set. Favorable microbiological response rate is measured by comparing TOC microbiological data to baseline microbiological data. In the absence of TOC microbiological data it is presumed from the clinical response.|7 to 20 days after the last dose of study drug|Microbiologically modified-intent-to-treat (mMITT)||Participant|||Number
685649|NCT01499277|Primary|Clinical Response at TOC in Clinically Evaluable (CE) Analysis Set|The observed difference in the clinical cure rates at TOC (ceftaroline group minus vancomycin plus aztreonam group) in CE. Clinical cure rate is measured by comparing the participant’s signs and symptoms at TOC visit to those recorded at study baseline.|7 to 20 days after the last dose of study drug|Clinical evaluable (CE)||Participant|||Number
685650|NCT01499277|Primary|Clinical Response at Test of Cure (TOC) in Modified Intent-to-treat (MITT) Analysis Set|The observed difference in the clinical cure rates at TOC (ceftaroline group minus vancomycin plus aztreonam group) in MITT. Clinical cure rate is measured by comparing the participant's signs and symptoms at TOC visit to those recorded at study baseline.|7 to 20 days after the last dose of study drug|Modified intent-to-treat (MITT)||Participant|||Number
685651|NCT01499199|Secondary|Number of Participants With Treatment-emergent Genotypic and Phenotypic Resistance to DTG and Other Antiretroviral Therapy (ART)|The number of participants with treatment-emergent genotypic and phenotypic resistance to integrase inhibitors (INIs), nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transctiptase inhibitors (NNRTIs), and protease inhibitors (PIs) was assessed.|Baseline through the date the last participant completed Week 96|Protocol Defined Virologic Failure (PDVF) Genotypic Population (Integrase inhibitor [IN] Results at Baseline and PDVF): The PDVF Genotypic and Phenotypic populations consisted of all participants in the ITT-E Population with available on-treatment genotypic and phenotypic resistance data, respectively, at the time of PDVF||participants|||Number
685662|NCT01499199|Primary|DTG Concentrations in CSF at Weeks 2 and Week 16|CSF is a clear, colorless bodily fluid produced in the choroid plexus of the brain. The CFS samples were collected at the Week 2 and Week 16 visits, within 1 hour of plasma PK sampling. DTG concentration in CSF were calculated at the Week 2 and Week 16 visits.|Week 2 and Week 16|CSF DTG Concentration Population: all participants receiving DTG who underwent lumbar puncture during the study and provided evaluable DTG CSF concentration data. One participant was excluded from the analysis at Week 2.||Nanograms per milliliter (ng/mL)||Full Range|Median
685652|NCT01499199|Secondary|The Numbers of Participants (Par.) With Clinical Adverse Events or Laboratory Abnormalities|An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs/SAEs. Any abnormal laboratory test result (hematology, clinical chemistry, or urinalysis) or other safety assessments (e.g., electrocardiograms [ECGs], radiological scans, vital sign measurements), including those that worsen from Baseline, and were felt to be clinically significant in the medical and scientific judgment of the investigator, were recorded as AEs or SAEs. Clinically suspected cases of hypersensitivity to ABC were also SAEs.|Baseline (BL) through the date the last participant completed Week (W) 96 + the follow-up visit (if applicable)|Safety Population: all participants who received at least one dose of study medication. Participants were analyzed according to the actual treatments received. Participants were not excluded from this population as a result of changes to the background regimen.||participants|||Number
685653|NCT01499199|Secondary|Number of Participants With Post-Baseline HIV-1-associated Conditions, Including Recurrences|The number of participants who reported a new or recurrent Centers for Disease Control and Prevention (CDC) Class B or Class C condition was assessed from Baseline though the date the last participant completed Week 96 + the follow-up visit (if applicable). Category (CAT) A: one or more of the following conditions (CON), without any CON listed in Categories B and C: asymptomatic HIV infection, persistent generalized lymphadenopathy, acute (primary) HIV infection with accompanying illness or history of acute HIV infection. CAT B: symptomatic CON that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or that are considered by physicians to have a clinical course or to require management that is complicated by HIV infection; and not included among CON listed in clinical CAT C. CAT C: the clinical CON listed in the AIDS surveillance case definition.|Baseline through the date the last participant completed Week 96 + follow-up visit (if applicable)|ITT-E Population||participants|||Number
685654|NCT01499199|Secondary|Absolute Values and Change From Baseline in Cluster of Differentiation 8+ (CD8+) Cell Counts at Weeks 4, 12, 16, 24, 48, and 96|The absolute value for CD48+ cell count (cells per millimeters cubed [mm^3]) was assessed at Baseline, Week 4, Week 12, Week 16, Week 24, Week 48, and Week 96. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; Weeks 4, 12, 16, 24, 48, and 96|ITT-E Population. Only those participants available at the indicated time point were assessed.||cells/mm^3||Full Range|Median
685655|NCT01499199|Secondary|Absolute Values and Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, and 96|The absolute value for CD4+ cell count (cells per millimeters cubed [mm^3]) was assessed at Baseline, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, and Week 96. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, and 96|ITT-E Population. Only those participants available at the indicated time point were assessed.||cells/mm^3||Full Range|Median
685656|NCT01499199|Secondary|Pearson Correlation Between CSF DTG Concentration and Absolute Values and Change From Baseline (CFB) in CSF HIV-1 RNA at Week 2, Week 16, and Overall|The Pearson Correlation Coefficient is a measure of the correlation between CSF DTG concentrations and absolute values/changes from Baseline in CSF HIV-1 RNA at Week 2 and Week 16. CSF HIV-1 RNA is measured as log10 copies per milliliter (copies/mL).|From Baseline to Week 16|CSF Pharmacodynamic Population. The overall analysis combines Week 2 and Week 16 data; thus, analysis was performed on 22 data points from 11 participants.||Pearson Correlation Coefficient||90% Confidence Interval|Mean
685657|NCT01499199|Secondary|Number of Participants With the Indicated Number of Copies of HIV-1 RNA in Both the CSF and Plasma at Baseline, Week 2, and Week 16|The relationship between HIV-1 RNA suppression in plasma and the CSF was measured as a comparison and as a change in the number of participants in the cross tabulation of <50 copies/mL in plasma, <50 copies/mL in CSF, >=50 copies/mL in plasma, and >=50 copies/mL in CSF at Baseline, Week 2, and Week 16.|Baseline, Week 2, and Week 16|CSF Pharmacodynamic Population. Only those participants available at the indicated time point were assessed.||participants|||Number
685658|NCT01499199|Secondary|Absolute Values and Change From Baseline in CSF HIV-1 RNA Levels at Week 2 and Week 16|The antiviral activity of dolutegravir in CSF over time was measured as absolute values and change from Baseline in HIV-1 RNA levels in CSF at Week 2 and Week 16. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline, Week 2, and Week 16|CSF Pharmacodynamic Population. Only those participants available at the indicated time points were assessed.||log10 c/mL||Full Range|Median
685659|NCT01499199|Secondary|Number of Participants With CSF HIV-1 RNA <50 Copies/Milliliter (c/mL) at Baseline, Week 2, and Week 16|The antiviral activity of dolutegravir in CSF over time was measured as the number of participants with HIV-1 RNA <50 copies/milliliter (c/mL).|Baseline, Week 2, and Week 16|CSF Pharmacodynamic Population: all participants who received DTG and underwent lumbar puncture during the study and provided CSF HIV-1 RNA data. Only those participants available at the indicated time points were assessed.||participants|||Number
685660|NCT01499199|Secondary|Absolute Values and Change From Baseline in Plasma Human Immunodeficiency Virus (HIV-1) Ribonucleic Acid (RNA) Levels at Weeks 2, 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, and 96|The plasma samples were collected at the Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, and Week 96 visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; Weeks 2, 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, and 96|ITT-E Population. Only those participants available at the indicated time point were assessed.||log10 copies/mL||Full Range|Median
685661|NCT01499199|Secondary|Number of Participants With Plasma HIV-1 RNA <50 Copies Per Milliliter (c/mL) at Baseline and Weeks 2, 4, 8, 12, and 16|HIV-1 RNA response in plasma was measured as the number of participants with HIV-1 RNA less than 50 c/mL at Baseline, Week 2, Week 4, Week 8, Week 12, and Week 16.|Baseline; Weeks 2, 4, 8, 12, and 16|Intent -to-Treat Exposed (ITT-E) Population: all participants who received at least one dose of investigational product||participants|||Number
686348|NCT01490931|Primary|Comparison of Pain Intensity Scores at 20 Minutes With the Baseline Pain Intensity Score During the Initial 6-hour Evaluation Period.|Pain intensity scores will be recorded by patient employing a standard 100 mm visual analog scale|20 minutes post dose|||millimeters||Standard Error|Mean
685665|NCT01499199|Primary|Total DTG Plasma Concentrations at Week 2 and Week 16|Total plasma DTG concentrations were calculated at the Week 2 and Week 16 visits.|Week 2 and Week 16|Plasma DTG Concentration Population: all participants receiving DTG who underwent PK sampling during the study and provided evaluable DTG plasma concentration data||Micrograms per milliliter (µg/mL)||Full Range|Median
685666|NCT01499199|Primary|The Ratio of Total and Unbound DTG Concentrations Between Cerebrospinal Fluid (CSF) and Plasma at Week 2 and Week 16|Cerebrospinal fluid (CSF) is a clear, colorless bodily fluid produced in the choroid plexus of the brain. The CFS samples were collected at the Week 2 and Week 16 visits, within 1 hour of plasma pharmacokinetic (PK) sampling. The ratio (presented as a percentage) of CSF DTG concentration over paired plasma total DTG concentration (RCSF_plasma) was calculated at the Week 2 and Week 16 visits.|Week 2 and Week 16|Plasma/CSF DTG Paired Sample Population: participants (par.) with plasma and CSF samples collected post-dose and within 1 hour of each other (one par. withdrew prior to Week 2 and did not contribute to PK assessments). One par. was excluded from the analysis at Week 2 because his/her paired samples were not collected within the specified timeframe.||percentage||Full Range|Median
685667|NCT01499173|Other Pre-specified|Program Satisfaction|Program satisfaction is measured by percentage of participants that completed the program who answered on the post test: very satisfied or extremely satisfied on a questionnaire about the program.|1 week elapsed between a pretest before 1st workshop and post-test at the end of 2nd workshop|||percentage of participants|||Number
685668|NCT01499173|Secondary|Perception of Stroke Attitude Clustered Within Churches Across Multiple Time Points|"Stroke attitude is measured by the odds ratio of participant’s positive perception of calling 911 for stroke. Odds ratios measure the odds of responses, so higher odds ratios suggest greater odds of stroke attitude change in the post-test compared to pre-test. Stroke attitude questioners were: Q1) If I were to see signs of a stroke, calling 911 would be... (range extremely pleasant to very unpleasant); and Q2) If a person has signs of a stroke, calling 911 right away could be... (range very helpful to very harmful). Given that participants within each church are more alike than participants between churches and multiple time points, hierarchical models were used. Specifically, multilevel mixed-effects ordered logistic regression models with a fixed church-level intercept and a random participant level intercept were used to explore change between baseline and immediate post-test and baseline and delayed post-test stroke attitude after accounting for the participants’ church."|1 week between pretest before 1st workshop and post-test at the end of 2nd workshop and 1 month till the delayed post test|||Odds ratio|||Number
685669|NCT01499173|Secondary|Perception of Self-efficacy Clustered Within Churches Across Multiple Time Points|Perception of self-efficacy is measured by the odds ratios of the responses to questions of participant confidence in being able to identify and respond appropriately to a stroke. Odds ratios measure the odds of responses, so higher odds ratios suggest greater odds of positive self-efficacy change in the post-test compared to the pretest. Questions asking about self-efficacy were:1) I would be able to tell if someone is having a stroke and 2) I know what to do if I saw someone having a stroke. Given that participants within each church are more alike than participants between churches and multiple time points hierarchical models were used. Specifically, multilevel mixed-effects ordered logistic regression models with a fixed church-level intercept and a random participant level intercept were used to explore change between baseline and immediate post-test and baseline and delayed posttest self-efficacy after accounting for the participants’ church.|1 week between pretest before 1st workshop and post-test at the end of 2nd workshop and 1 month till the delayed post test|||odds ratio|||Number
685670|NCT01499173|Secondary|Perception of Social Norms Clustered Within Churches Across Multiple Time Points|Perception of social norms is measured by the odds ratio of the responses to questions of participant agreement with others' influence to calling 911 if he/she were to see a stroke. Odds ratios measure the odds of responses, so higher odds ratios suggest greater odds of the positive change in social norms in the post-test compared to the pre-test. Questions: 1) Most people would call 911 if they were to see a stroke. 2) My family would want me to call 911 if I were to see a stroke. Given that participants within each church are more alike than participants between churches and the multiple time points, hierarchical models were used. Specifically, multilevel mixed-effects ordered logistic regression models with a fixed church-level intercept and a random participant level intercept were used to explore change between baseline and immediate post-test and baseline and delayed post-test social norms after accounting for the participants’ church.|1 week between pretest before 1st workshop and post-test at the end of 2nd workshop and 1 month till the delayed post test|||odds ratio|||Number
685671|NCT01499173|Secondary|Mean Change in Stroke Recognition|Stroke recognition was scored on a 0 - 9 point scale where 0 represents no correct answers regarding 9 scenarios and 9 represents perfect stroke recognition.|1 week elapsed between a pretest before 1st workshop and post-test at the end of 2nd workshop|||units on a scale||95% Confidence Interval|Mean
685672|NCT01499173|Secondary|Mean Change in Behavioral Intent to Call 911|The pre-test is conducted one week prior to the post-test. A higher score indicates greater behavioral intent. Behavioral intent is measured on a scale of 0 - 8, where 0 indicates no correct answers in responses to scenarios, and 8 indicates appropriate responses (calling 911 every time it is appropriate) to the scenarios presented.|1 week elapsed between a pretest before 1st workshop and post-test at the end of 2nd workshop|||units on a scale||95% Confidence Interval|Mean
685673|NCT01499173|Primary|Completion|Number of participants who complete the intervention|1 week|descriptive||Participants|||Count of Participants
685674|NCT01499147|Secondary|Number of Participants With Moderate to Severe (Grade 2-4) Acute Graft Versus Host Disease (GVHD).|Acute GVHD grade 2-4 was assessed in patients in the FluBU and FluMel groups up to 100 days after transplant.|Up to 100 days post-transplant (acute GVHD).|||participants|||Number
685675|NCT01499147|Secondary|Time to ANC and Platelet Engraftment|Days|Up to 30 days post-transplant|||time to ANC and platelet engraftment||Full Range|Median
685676|NCT01499147|Secondary|Participants With 100 Day Transplant-related Mortality.|Day 100 transplant-related mortality was measured in both groups.|Up to 100 days post-transplant.|||participants|||Number
685677|NCT01499147|Primary|Number of Participants With Engraftment.|Median time to ANC engraftment and platelet engraftment in both groups as well as the transfusion requirements measured within 30 days after transplant.|Up to 30 days post-transplant|||participants|||Number
685678|NCT01499134|Secondary|Walking Impairment Questionnaire (WIQ) - Change in WIQ Stairs Score|Change in stairs score as captured by the Walking Impairment Questionnaire (WIQ) stairs subscale. This scale item asks the subject to describe the degree of difficulty climbing one, two, or three flights of stairs in the past week. A flight of stairs is defined as 14 steps. A 5 point Likert scale scoring ranges from 1) No Difficulty, 2) Slight Difficulty, 3) Some Difficulty, 4) Much Difficulty, 5) Unable to Do, or 6) Didn Do for Other Reasons. The items on the subscale are weighted according to the difficulty of the task. The stairs score is determined by dividing the total weighted score by the greatest possible weighted score and multiplying by 100. Scores range from 0-100.|Baseline WIQ is completed at the time of enrollment and again at the final study visit at 26 weeks.|"Four people in the nebivolol group and 1 person in the metoprolol group did not complete the items in the Stairs WIQ subscale therefore they were excluded from the analysis. One person in the metoprolol succinate group withdrew consent before the end of the study so they were also excluded from the final analysis."||units on a scale||Standard Deviation|Mean
685679|NCT01499134|Secondary|Walking Impairment Questionnaire (WIQ) - Change in WIQ Speed Score|Change in speed score as captured by the Walking Impairment Questionnaire (WIQ) speed score subscale. In the walking speed component, the degree of difficulty walking is ranked on a 0 to 4 scale where speed is assessed for each of the following speeds: at the following speeds: 1, slowly; 2, average speed; 3, quickly; or 4, running or jogging 1 block. Zero represents the inability to walk the specified speed, and 4 represents no difficulty. The items on the subscale are weighted according to the difficulty of the task. The speed score is determined by dividing the total weighted score by the greatest possible weighted score and multiplying by 100. Scores range from 0-100.|Baseline WIQ is completed at the time of enrollment and again at the final study visit at 26 weeks.|One patient in the metoprolol succinate group withdrew consent prior to the end of the study, therefore, only 7 participants are included in the analysis for this group. One patient in the nebivolol group failed to complete the items in the WIQ speed score subscale, therefore, only 8 patients were included in the analysis for this outcome.||units on a scale||Standard Deviation|Mean
685680|NCT01499134|Secondary|Walking Impairment Questionnaire (WIQ) - Change in WIQ Distance Score|Change in distance score as captured by the Walking Impairment Questionnaire (WIQ) distance score subscale. The degree of difficulty in the walking of specific distances is ranked on a 0 to 4 Likert scale, in which 0 represents the inability to walk the distance and 4 represents no difficulty. A Likert scale is an ordinal scale of consecutive, equidistant, numerical values (ie, 0 to 4). The distances assessed in the WIQ range from walking indoors around the home to walking 5 blocks (1500 feet). The items on the subscale are weighted according to the difficulty of walking. The distance score is determined by dividing the total weighted score by the greatest possible weighted score and multiplying by 100. Scores range from 0-100.|Baseline WIQ is completed at the time of enrollment and again at the final study visit at 26 weeks.|One patient in the metoprolol succinate group withdrew consent prior to the end of the study, therefore, only 7 participants are included in the analysis for this group.||units on a scale||Standard Deviation|Mean
685681|NCT01499134|Secondary|Walking Impairment Questionnaire (WIQ) - Change in Buttock Pain|Change in buttock pain as captured by the Walking Impairment Questionnaire (WIQ). A 5 point Likert scale scoring ranges from 1) No Difficulty, 2) Slight Difficulty, 3) Some Difficulty, 4) Much Difficulty, and 5) Great Difficulty. The scores are determined by dividing the score by the maximum possible score and then multiplying by 100. The score ranges from 0-100 with lower scores indicating greater pain.|Baseline WIQ is completed at the time of enrollment and again at the final study visit at 26 weeks.|One patient in the metoprolol succinate group withdrew consent prior to the end of the study, therefore, only 7 participants are included in the analysis for this group.||units on a scale||Standard Deviation|Mean
685682|NCT01499134|Secondary|Walking Impairment Questionnaire (WIQ) - Change Calf Pain|Change in calf pain as captured by the Walking Impairment Questionnaire (WIQ). A 5 point Likert scale scoring ranges from 1) No Difficulty, 2) Slight Difficulty, 3) Some Difficulty, 4) Much Difficulty, and 5) Great Difficulty. The scores are determined by dividing the score by the maximum possible score and then multiplying by 100. The score ranges from 0-100 with lower scores indicating greater pain.|Baseline WIQ is completed at the time of enrollment and again at the final study visit at 26 weeks.|One patient in the metoprolol succinate group withdrew consent prior to the end of the study, therefore, only 7 participants are included in the analysis for this group.||units on a scale||Standard Deviation|Mean
685683|NCT01499134|Secondary|Claudication Onset Time (COT)|Change in measurement of claudication onset time (COT). The COT is defined as the time when a patient first experienced pain walking during a treadmill test.|Baseline COT is measured at the time of enrollment and again at the final study visit at 26 weeks.|Final measurements of COT in the metoprolol succinate group excludes one subject who did not experience claudication while walking during the treadmill test, and one subject who withdrew consent prior to the end of the study, therefore, only 6 participants are included in the analysis for this group.||seconds||Standard Deviation|Mean
685684|NCT01499134|Secondary|Ankle-brachial Index (ABI)|Change in measurement of Ankle-brachial index (ABI). The ABI is the ratio of the blood pressure measured in the lower legs to the blood pressure measured in the arms.|Baseline ABI is measured at the time of enrollment and again at the final study visit at 26 weeks|One patient in the metoprolol succinate group withdrew consent prior to the end of the study, therefore, only 7 participants are included in the analysis for this group.||Ankle-Brachial Index||Standard Deviation|Mean
685685|NCT01499134|Primary|Peak Walking Time (PWT)|Change in peak walking time (PWT) is measured in seconds. The PWT is defined as when walking on a treadmill cannot continue due to maximal leg pain, resulting in the discontinuation of the treadmill test.|Baseline PWT is measured at the time of enrollment and again at the final study visit at 26 weeks.|One patient in the metoprolol succinate group withdrew consent prior to the end of the study, therefore, only 7 participants are included in the analysis for this group.||seconds||Standard Deviation|Mean
685686|NCT01499095|Other Pre-specified|Change in HbA1c From Month 6 to Month 9|Substudy comparing fixed dosing regimen (every 24 hours) vs. adaptive dosing regimen (every 24 +/- 3 hours) in a subset of participants randomized to HOE901-U300 and treated for 6 months. Only measurements performed before initiation of rescue therapy were considered in the analysis.|Month 6 up to Month 9|mITT substudy population. Number of participants analyzed = participants with Month 6 and Month 9 HbA1c assessment. Analysis was planned to be performed for participants who were receiving HOE901­U300 (Adaptable dosing intervals or Fixed dosing intervals). Missing data imputed using last observation carried forward.||percentage of hemoglobin||Standard Error|Least Squares Mean
685687|NCT01499095|Secondary|Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline to Month 12|Hypoglycemia events were Severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); Documented symptomatic hypoglycemia (typical symptoms of hypoglycemia with plasma glucose level of <=3.9 mmol/L [70 mg/dL]); Asymptomatic hypoglycemia (no typical symptoms of hypoglycemia but plasma glucose level <=3.9 mmol/L); Probable symptomatic hypoglycemia (an event during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination, but was presumably caused by a plasma glucose level <=3.9 mmol/L, symptoms treated with oral carbohydrate without a test of plasma glucose); Relative hypoglycemia (an event during which the person with diabetes reported any of the typical symptoms of hypoglycemia, and interpreted the symptoms as indicative of hypoglycemia, but plasma glucose level >3.9 mmol/L); Severe and/or confirmed a hypoglycemia (plasma glucose <=3.9 mmol/L).|Up to Month 12|Safety population: all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. In the event of participants having received treatments different from those assigned according to the randomization schedule, safety analyses were conducted according to treatment received.||percentage of participants|||Number
685688|NCT01499095|Secondary|Change in Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint|DTSQ is a validated measure to assess how satisfied participants with diabetes are with their treatment and how they perceive hyper­ and hypoglycemia. It consists of 8 questions which are answered on a Likert scale from 0 to 6. DTSQ treatment satisfaction score is the sum of question 1 and 4­8 scores and ranges between 0 and 36, where higher scores indicate more treatment satisfaction. Only measurements performed before initiation of rescue therapy were considered in the analysis.|Baseline, Month 6|mITT Population. Number of participants analyzed = participants with Baseline and Month 6 DTSQ assessment. Missing data imputed using last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
685689|NCT01499095|Secondary|Change in Daily Basal Insulin Dose From Baseline to Month 6 Endpoint|Only measurements performed before initiation of rescue therapy were considered in the analysis.|Baseline, Month 6|mITT Population. Number of participants analyzed = participants with Baseline and Month 6 basal insulin dose assessment. Missing data imputed using last observation carried forward.||U/kg||Standard Error|Least Squares Mean
685690|NCT01499095|Secondary|Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint|Change in each time­point of 8­point SMPG profile: 03:00 hours (clock time) at night; before and 2 hours after breakfast; before and 2 hours after lunch; before and 2 hours after dinner; and at bedtime. Only measurements performed before initiation of rescue therapy were considered in the analysis.|Baseline, Month 6|mITT population. Only participants from the mITT population with a value at baseline and at the specified timepoint were analyzed (represented by n=X, X in the category titles). Missing data imputed using last observation carried forward.||mmol/L||Standard Error|Least Squares Mean
685691|NCT01499095|Secondary|Percentage of Participants With FPG <5.6 mmol/L (<100 mg/dL) at Month 6 Endpoint|Only measurements performed before initiation of rescue therapy were considered in the analysis.|Month 6|mITT Population. Number of participants analyzed = participants with Month 6 FPG assessment. Missing data imputed using last observation carried forward.||percentage of participants|||Number
685692|NCT01499095|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Month 6 Endpoint|Only measurements performed before initiation of rescue therapy were considered in the analysis.|Baseline, Month 6|mITT Population. Number of participants analyzed = participants with baseline and Month 6 FPG assessment. Missing data imputed using last observation carried forward.||mmol/L||Standard Error|Least Squares Mean
685693|NCT01499095|Secondary|Percentage of Participants With HbA1c <7% at Month 6 Endpoint|Only measurements performed before initiation of rescue therapy were considered in the analysis.|Month 6|mITT Population. Number of participants analyzed = participants with Month 6 HbA1c assessment. Missing data imputed using last observation carried forward.||percentage of participants|||Number
685694|NCT01499095|Secondary|Change in Variability of Preinjection SMPG From Baseline to Month 6 Endpoint|Preinjection SMPG was measured within 30 minutes prior to the injection of the study drug. Variability was assessed by the mean of co-efficient of variation calculated as 100 multiplied by (standard deviation/mean) over at least 3 SMPG measured during the 7 days preceding the assessment visit. Only measurements performed before initiation of rescue therapy were considered in the analysis.|Baseline, Month 6|mITT population. Missing data imputed using last observation carried forward. Number of participants analyzed = participants with baseline and Month 6 preinjection SMPG assessment.||percentage of mean||Standard Error|Least Squares Mean
685695|NCT01499095|Secondary|Change in Average Preinjection Self-Monitored Plasma Glucose (SMPG) From Baseline to Month 6 Endpoint|Preinjection SMPG was measured within 30 minutes prior to the injection of the study drug. Average was assessed by the mean of at least 3 SMPG calculated over the 7 days preceding the assessment visit. Only measurements performed before initiation of rescue therapy were considered in the analysis.|Baseline, Month 6|mITT population. Missing data imputed using last observation carried forward. Number of participants analyzed = participants with baseline and Month 6 preinjection SMPG assessment.||mmol/L||Standard Error|Least Squares Mean
685696|NCT01499095|Secondary|Percentage of Participants With At Least One Severe and/or Confirmed Nocturnal Hypoglycemia From Start of Week 9 to Month 6 Endpoint|Nocturnal hypoglycemia was hypoglycemia that occurred between 00:00 and 05:59 hours (clock time), regardless the participant was awake or woke up because of the event. Severe hypoglycemia was an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Confirmed hypoglycemia was an event associated with plasma glucose less than or equal to (<=) 3.9 mmol/L (70 milligram per deciliter [mg/dL]). Only measurements performed before initiation of rescue therapy were considered in the analysis.|Week 9 Up to Month 6|Modified intent­to­treat population.||percentage of participants|||Number
685697|NCT01499095|Primary|Change in HbA1c From Baseline to Month 6 Endpoint|Only measurements performed before initiation of rescue therapy were considered in the analysis.|Baseline, Month 6|Modified Intent-to-Treat population: all randomized participants who received at least (>=)1 dose, had baseline and >=1 post-baseline assessment of any efficacy variable, irrespective of compliance. Number of participants analyzed = participants with baseline and Week 6 HbA1c assessment. Missing data imputed using last observation carried forward.||percentage of hemoglobin||Standard Error|Least Squares Mean
685698|NCT01499082|Other Pre-specified|Change in HbA1c From Month 6 to Month 9|Substudy comparing fixed dosing regimen (every 24 hours) vs. adaptive dosing regimen (every 24 +/- 3 hours) in a subset of participants randomized to HOE901-U300 and treated for 6 months.|Month 6 Up to Month 9|mITT substudy population. Number of participants analyzed = participants with Month 6 and Month 9 HbA1c assessment. Analysis was planned to be performed for participants enrolled in the substudy and who were receiving HOE901-U300 (Adaptable dosing intervals or Fixed dosing intervals).||percentage of hemoglobin||Standard Error|Least Squares Mean
685699|NCT01499082|Secondary|Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline up to Month 12|Hypoglycemia events were Severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); Documented symptomatic hypoglycemia (typical symptoms of hypoglycemia with plasma glucose level of <=3.9 mmol/L [70 mg/dL]); Asymptomatic hypoglycemia (no typical symptoms of hypoglycemia but plasma glucose level <=3.9 mmol/L); Probable symptomatic hypoglycemia (an event during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination, but was presumably caused by a plasma glucose level <=3.9 mmol/L, symptoms treated with oral carbohydrate without a test of plasma glucose); Relative hypoglycemia (an event during which the person with diabetes reported any of the typical symptoms of hypoglycemia, and interpreted the symptoms as indicative of hypoglycemia, but plasma glucose level >3.9 mmol/L); Severe and/or confirmed a hypoglycemia (plasma glucose <=3.9 mmol/L).|Up to Month 12|Safety population: all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. In the event of participants having received treatments different from those assigned according to the randomization schedule, safety analyses were conducted according to treatment received.||percentage of participants|||Number
685700|NCT01499082|Secondary|Change in Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint|DTSQ is a validated measure to assess how satisfied participants with diabetes are with their treatment and how they perceive hyper- and hypoglycemia. It consists of 8 questions which are answered on a Likert scale from 0 to 6. DTSQ treatment satisfaction score is the sum of question 1 and 4-8 scores and ranges between 0 and 36, where higher scores indicate more treatment satisfaction.|Baseline, Month 6|mITT Population. Number of participants analyzed = participants with Baseline and Month 6 DTSQ assessment. Missing data imputed using last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
685701|NCT01499082|Secondary|Change in Daily Basal Insulin Dose From Baseline to Month 6 Endpoint||Baseline, Month 6|mITT Population. Number of participants analyzed = participants with Baseline and Month 6 basal insulin dose assessment. Missing data imputed using last observation carried forward.||U/kg||Standard Error|Least Squares Mean
685702|NCT01499082|Secondary|Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint|Change in each time-point of 8-point SMPG profile: 03:00 hours (clock time) at night; before and 2 hours after breakfast; before and 2 hours after lunch; before and 2 hours after dinner; and at bedtime.|Baseline, Month 6|mITT Population. Here, n = participants with Baseline and Month 6 8-point SMPG assessment separately for each analysed time point. Missing data imputed using last observation carried forward.||mmol/L||Standard Error|Least Squares Mean
685703|NCT01499082|Secondary|Percentage of Participants With FPG <5.6 mmol/L (<100 mg/dL) at Month 6 Endpoint||Month 6|mITT Population. Number of participants analyzed = participants with Month 6 FPG assessment. Missing data imputed using last observation carried forward.||percentage of participants|||Number
685704|NCT01499082|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Month 6 Endpoint||Baseline, Month 6|mITT Population. Number of participants analyzed = participants with baseline and Month 6 FPG assessment. Missing data imputed using last observation carried forward.||mmol/L||Standard Error|Least Squares Mean
685705|NCT01499082|Secondary|Percentage of Participants With HbA1c <7% at Month 6 Endpoint||Month 6|mITT Population. Number of participants analyzed = participants with baseline and Month 6 HbA1c assessment. Missing data imputed using last observation carried forward.||percentage of participants|||Number
685706|NCT01499082|Secondary|Change in Variability of Preinjection SMPG From Baseline to Month 6 Endpoint|Pre-injection SMPG was measured within 30 minutes prior to the injection of the study drug. Variability was assessed by the mean of coefficient of variation calculated as 100 multiplied by (standard deviation/mean) over at least 3 SMPG measured during the 7 days preceding the assessment visit.|Baseline, Month 6|mITT population. Missing data imputed using last observation carried forward. Number of participants analyzed = participants with baseline and Month 6 pre-injection SMPG assessment.||percentage of mean||Standard Error|Least Squares Mean
685707|NCT01499082|Secondary|Change in Average Preinjection Self-Monitored Plasma Glucose (SMPG) From Baseline to Month 6 Endpoint|Pre-injection SMPG was measured within 30 minutes prior to the injection of the study drug. Average was assessed by the mean of at least 3 SMPG calculated over the 7 days preceding the assessment visit.|Baseline, Month 6|mITT population. Missing data imputed using last observation carried forward. Number of participants analyzed = participants with baseline and Month 6 pre-injection SMPG assessment.||mmol/L||Standard Error|Least Squares Mean
685708|NCT01499082|Secondary|Percentage of Participants With At Least One Severe and/or Confirmed Nocturnal Hypoglycemia From Start of Week 9 to Month 6 Endpoint|Nocturnal hypoglycemia was hypoglycemia that occurred between 00:00 and 05:59 hours (clock time), regardless the participant was awake or woke up because of the event. Severe hypoglycemia was an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Confirmed hypoglycemia was an event associated with plasma glucose less than or equal to (<=) 3.9 millimoles per liter (mmol/L) (70 milligram per deciliter [mg/dL]).|Week 9 Up to Month 6|Modified intent-to-treat population.||percentage of participants|||Number
685709|NCT01499082|Primary|Change in HbA1c From Baseline to Month 6 Endpoint||Baseline, Month 6|Modified Intent-to-Treat population: all randomized participants who received at least (>=)1 dose, had baseline and >=1 post-baseline assessment of any efficacy variable, irrespective of compliance. Number of participants analyzed = participants with baseline and Week 6 HbA1c assessment. Missing data imputed using last observation carried forward.||percentage of hemoglobin||Standard Error|Least Squares Mean
685896|NCT01496274|Secondary|Proportion of Bleeding Episodes Requiring One or ≤ Two Injections of rIX-FP to Achieve Hemostasis|Number of injections required to achieve hemostasis expressed as a percentage of the bleeding episodes requiring treatment.|For the duration of the study; median 20.27 months.|Efficacy Population||percentage of bleeding episodes treated|Participants||Number
685710|NCT01498822|Secondary|Percentage of Subjects Who Achieved Seizure Freedom During the 48 Weeks Treatment Period|48-week Seizure Freedom (rate) defined as the number and percentage of subjects who achieved seizure freedom during the Treatment Period|From Week 2 to Week 50 (During Treatment Period )|"The Full Analysis Set (FAS) consisted of all subjects who received at least 1 (partial) dose of study mediaction and returned at least 1 post-Baseline seizure diary.
A randomized subject was only excluded from the FAS when there was clear evidence that the subject did not take any study medication."||percentage of subjects|||Number
685711|NCT01498822|Secondary|Percentage of Subjects Who Achieved Seizure Freedom for 24 Consecutive Weeks During the 48 Weeks Treatment Period at Any Time|24-week Seizure Freedom (rate) defined as the number and percentage of subjects who achieved seizure freedom for 24 consecutive weeks during the Treatment Period at any time|From Week 2 to Week 50 (During Treatment Period )|"The Full Analysis Set (FAS) consisted of all subjects who received at least 1 (partial) dose of study mediaction and returned at least 1 post-Baseline seizure diary.
A randomized subject was only excluded from the FAS when there was clear evidence that the subject did not take any study medication."||percentage of subjects|||Number
685712|NCT01498822|Secondary|Time to the First Seizure Defined as the Time From the First Dose of Medication to the Occurrence of the First Seizure During the 48 Weeks Treatment Period||From Week 2 to Week 50 (During Treatment Period )|"The Full Analysis Set (FAS) consisted of all subjects who received at least 1 (partial) dose of study mediaction and returned at least 1 post-Baseline seizure diary.
A randomized subject was only excluded from the FAS when there was clear evidence that the subject did not take any study medication."||months||Full Range|Median
685713|NCT01498822|Primary|Percentage of Subjects With a Treatment Failure|Treatment failure is defined as (1) Dropout due to related intolerable adverse event, lack of efficacy or need for addition of another Antiepileptic Drug (AED), or (2) need of a 1-step down-Titration, within 50 weeks from the first dose of study medication.|Week 0 (First Dose) to Week 50|Per Protocol Set (PPS) consisted of all subjects who received at least 1 (partial) dose of study mediaction, returned at least 1 post-Baseline seizure diary and had no important protocol deviations. Subjects who discontinued the study before Week 50 for any reason other than treatment failure were excluded from the PPS.||percentage of subjects|||Number
685714|NCT01498744|Secondary|Complication to Antibiotic Regime||Three timepoints: 10-14 days post operation, 3 months post op, and 9 months post op|Only participants that had data collected for this outcome measure are included above.||participants|||Number
685715|NCT01498744|Secondary|Additional Skin or Soft Tissue Infections in Household Contacts||Three timepoints: 10-14 days post operation, 3 months post op, and 9 months post op|Only participants that had data collected for this outcome measure are included above.||participants|||Number
685716|NCT01498744|Secondary|Additional Skin and Soft Tissue Infections in Patient|The outcome measure was reported by responding to a yes/no|Three timepoints: 10-14 days post operation, 3 months post op, and 9 months post op|Only participants that had data collected for this outcome measure are included here.||participants|||Number
685717|NCT01498744|Primary|Clinical Resolution of Skin Abscess at Routine Follow-up Visit 10-14 Days Post Operation.||At office visit 10-14 days post operation|Only participants that had data collected for this outcome measure are included above.||participants|||Number
685718|NCT01498692|Secondary|Clinical Procedural Success|Defined as mean lesion diameter stenosis <30% with visually assessed TIMI 3 flow and without the occurrence of in-hospital MI, TVR, or cardiac death.|Duration of Hospital Stay (average 1-2 days)|Analysis was intention to treat||percentage of participants|||Number
685719|NCT01498692|Secondary|Acute Technical Success|Defined as successful delivery and deployment of the study stent to the target vessel, without balloon rupture or stent embolization; expressed per stent|During the index procedure (minutes)|Analysis was intention to treat||percentage of stents|stents||Number
685720|NCT01498692|Secondary|Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days)|>30 days-1 year|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants with ST|||Number
685721|NCT01498692|Secondary|Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days)|>24 hr-30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants with ST|||Number
685722|NCT01498692|Secondary|Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC)Definition|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days)|24 hours|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants with ST|||Number
685897|NCT01496274|Secondary|Number of Subjects Developing Antibodies Against rIX-FP||For the duration of the study; median 20.27 months.|Safety Population||participants|||Number
685898|NCT01496274|Secondary|The Frequency of Related Adverse Events|The percentage of participants experiencing treatment-related adverse-events (TEAEs).|For the duration of the study; median 20.27 months.|Safety Population||Percentage of participants|||Number
685723|NCT01498692|Secondary|Target Vessel Revascularization (TVR)|Any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.|30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants with TVR|||Number
685724|NCT01498692|Secondary|Target Vessel Revascularization (TVR)|Defined as any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants with TVR|||Number
685725|NCT01498692|Secondary|Target Vessel Revascularization (TVR)|Defined as any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants with TVR|||Number
685726|NCT01498692|Secondary|Target Lesion Revascularization TLR)|Defined as any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.|30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants with TLR|||Number
685727|NCT01498692|Secondary|Target Lesion Revascularization (TLR)|Defined as any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants with TLR|||Number
685728|NCT01498692|Secondary|Target Lesion Revascularization (TLR)|Defined as any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants with TLR|||Number
685729|NCT01498692|Secondary|Cardiac Death Related to the Target Vessel|Cardiac death is defined as death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded; see definition of MI above|30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
685730|NCT01498692|Secondary|Cardiac Death Related to the Target Vessel|Cardiac death is defined as death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded; see definition of MI above|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
685731|NCT01498692|Secondary|Cardiac Death Related to the Target Vessel|Defined as death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded; see definition of MI above.|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
685732|NCT01498692|Secondary|All Cause Mortality||30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
685733|NCT01498692|Secondary|All Cause Mortality||6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
685734|NCT01498692|Secondary|All Cause Mortality||12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
685735|NCT01498692|Secondary|Myocardial Infarction (MI) Related to the Target Vessel|New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase myoglobin band(CK-MB) or troponin >upper limit of normal(ULN); if no new Q-waves total CK levels >3×ULN (peri-percutaneous coronary intervention [PCI]) or >2×ULN (spontaneous) with elevated CK-MB or troponin >3×ULN (peri-PCI) or >2×ULN (spontaneous) plus ≥one of the following: ECG changes indicating new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5×ULN|30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants with MI|||Number
685765|NCT01498549|Primary|Rapid Visual Information Processing|Cognitive Test to determine the speed of Visual information. The CANTAB Rapid Visual Information Processing test (RVP) is a measure of sustained attention with a small working memory component (Sahakian and Owen, 1992). Digits are rapidly (100/minute) and pseudo-randomly presented for 7 minutes. Subjects are instructed to press when the third digit of a target sequence (e.g. 3-5-7) is displayed. Primary outcomes are indices of target discriminability (A’) and response bias (B”) and response latency to targets.|2 years|Participants that completed any arm in the crossover are included in the analysis.||Proportion of Participants||Standard Deviation|Mean
685736|NCT01498692|Secondary|Myocardial Infarction (MI) Related to the Target Vessel|New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase myoglobin band(CK-MB) or troponin >upper limit of normal(ULN); if no new Q-waves total CK levels >3×ULN (peri-percutaneous coronary intervention [PCI]) or >2×ULN (spontaneous) with elevated CK-MB or troponin >3×ULN (peri-PCI) or >2×ULN (spontaneous) plus ≥one of the following: ECG changes indicating new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5×ULN|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants with MI|||Number
685737|NCT01498692|Secondary|Myocardial Infarction (MI) Related to the Target Vessel|New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase myoglobin band(CK-MB) or troponin >upper limit of normal(ULN); if no new Q-waves total CK levels >3×ULN (peri-percutaneous coronary intervention [PCI]) or >2×ULN (spontaneous) with elevated CK-MB or troponin >3×ULN (peri-PCI) or >2×ULN (spontaneous) plus ≥one of the following: ECG changes indicating new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5×ULN|12 Months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants with MI|||Number
685738|NCT01498692|Secondary|Target Vessel Failure (TVF)|Target vessel failure (TVF) is defined as any ischemia-driven revascularization of the target vessel, myocardial infarction (MI;Q-wave and non–Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.|30 Days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
685739|NCT01498692|Secondary|Target Vessel Failure (TVF)|Target vessel failure (TVF) is defined as any ischemia-driven revascularization of the target vessel, myocardial infarction (MI;Q-wave and non–Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.|6 Months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
685740|NCT01498692|Secondary|Target Vessel Failure (TVF)|Target vessel failure (TVF) is defined as any ischemia-driven revascularization of the target vessel, myocardial infarction (MI;Q-wave and non–Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.|12 Months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
685741|NCT01498692|Secondary|Target Lesion Failure (TLF)|Defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel.|30 Days|Analysis was intention to treat; all participants underwent clinical follow-up to provide the information needed for this endpoint.||percentage of participants|||Number
685742|NCT01498692|Secondary|Target Lesion Failure (TLF)|Defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel.|6 Months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
685743|NCT01498692|Primary|Target Lesion Failure (TLF)|Defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel. The primary analysis set for the non-inferiority testing of the primary endpoint is the per-protocol analysis set. All randomized participants who received their assigned treatment are included in the per-protocol analysis set.|12 Months|The primary analysis set for comparison of the primary endpoint, 12-month TLF, to the predefined performance goal of 21.1% (based on historical TAXUS Express results) is the per-protocol analysis set. All enrolled participants who received a PROMUS Element stent are included in the per-protocol analysis set.||percentage of participants|||Number
685744|NCT01498679|Secondary|Change From Baseline in Total Asthma Quality of Life Questionnaire (AQLQ) Score at Week 12|The AQLQ is a disease-specific, self-administered quality of life questionnaire developed to evaluate the impact of asthma treatments on the quality of life of asthma sufferers. The AQLQ contains 32 items in 4 domains: activity limitation (11 items), symptoms (12 items), emotional function (5 items), and environmental stimuli (4 items). The 32 items of the questionnaire are averaged to produce one overall quality of life score. The response format consists of a 7-point scale, where a value of 1 indicates “total impairment” and a value of 7 indicates “no impairment.” Change from Baseline was calculated as the Week 12 value minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|Baseline and Week 12|ITT Population. Only those participants available at the indicated time point were assessed.||Scores on a scale||Standard Error|Least Squares Mean
685745|NCT01498679|Secondary|Mean Change From Baseline in the Percentage of Symptom-free 24- Hour (hr) Periods During the 12-week Treatment Period|Asthma symptoms were recorded in a daily diary by the participants every day in the morning and evening before taking any rescue or study medication and before PEF measurement. A 24-hour period in which a participant’s responses to both the morning and evening assessments indicated no symptoms was considered as symptom free. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Participants who were symptom free for 24-hour periods during the 12-week Treatment Period were assessed. Change from Baseline is calculated as the average value during the 12-week Treatment Period minus the value at Baseline. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|Baseline and Weeks 1-12 (up to Day 84)|ITT Population||Percentage of symptom-free 24-hr periods||Standard Error|Least Squares Mean
685746|NCT01498679|Secondary|Mean Change From Baseline in the Percentage of Rescue-free 24- Hour (hr) Periods During the 12-week Treatment Period|The number of inhalations of rescue albuterol/salbutamol inhalation aerosol (medication used to relieve symptoms immediately) used during the day and night was recorded by the participants in a daily diary. A 24-hour period in which a participant’s responses to both the morning and evening assessments indicated no use of rescue medication was considered as rescue free. Participants who were rescue free for 24-hour periods during the 12-week Treatment Period were assessed. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline is calculated as the average value during the 12-week Treatment Period minus the value at Baseline. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|Baseline and Weeks 1-12 (up to Day 84)|ITT Population||Percentage of rescue-free 24-hr periods||Standard Error|Least Squares Mean
685747|NCT01498679|Secondary|Mean Change From Baseline in Daily Morning (AM) PEF Averaged Over the 12-week Treatment Period|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the value of the averaged daily AM PEF over the 12-week Treatment Period minus the Baseline value. A Repeated Measures analysis adjusted for Baseline, region, sex, age, treatment, week, week by Baseline interaction, and week by treatment interaction was used.|Baseline and Weeks 1-12 (up to Day 84)|ITT Population. Only those participants who had AM PEF data for at least 2 days in the Baseline week prior to randomization and at least 2 days after randomization and were available at the indicated time point were assessed.||L/min||Standard Error|Least Squares Mean
685748|NCT01498679|Primary|Mean Change From Baseline (BL) in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 12-week Treatment Period|Peak Expiratory Flow is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the value of the averaged daily PM PEF over the 12-week Treatment Period minus the Baseline value. Analysis was performed using Analysis of Covariance (ANCOVA) with covariates of Baseline, region, sex, age, and treatment.|Baseline and Weeks 1-12 (up to Day 84)|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received >=1 dose of trial medication. The primary endpoint analysis only included participants who had PM PEF data for >=4 days in the BL week prior to randomization and >=4 days after randomization. Only participants available at the indicated time point were assessed.||Liters/minute (L/min)||Standard Error|Least Squares Mean
685749|NCT01498653|Secondary|Change From Baseline in Total Asthma Quality of Life Questionnaire (AQLQ) Score at Week 12|The AQLQ is a disease-specific, self-administered quality of life questionnaire developed to evaluate the impact of asthma treatments on the quality of life of asthma sufferers. The AQLQ contains 32 items in 4 domains: activity limitation (11 items), symptoms (12 items), emotional function (5 items), and environmental stimuli (4 items). The 32 items of the questionnaire are averaged to produce one overall quality of life score. The response format consists of a 7-point scale, where a value of 1 indicates “total impairment” and a value of 7 indicates “no impairment.” Change from Baseline was calculated as the Week 12 value minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|Baseline and Week 12|ITT Population. Only those participants available at the indicated time point were assessed.||Scores on a scale||Standard Error|Least Squares Mean
685750|NCT01498653|Secondary|Mean Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 12-week Treatment Period|Asthma symptoms were recorded in a daily dairy by the participants every day in the morning and evening before taking any rescue or study medication and before PEF measurement. A 24-hour period in which a participant’s responses to both the morning and evening assessments indicated no symptoms was considered as symptom free. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Participants who were symptom free for 24-hour periods during the 12-week Treatment Period were assessed. Change from Baseline is calculated as the average value during the 12-week Treatment Period minus the value at Baseline. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|Baseline and Weeks 1-12 (up to Day 84)|ITT Population. In addition, the analysis only included participants who had symptom-free 24-hour period data for at least 2 days in the Baseline week prior to randomization and at least 2 days after randomization. Only those participants available at the indicated time point were assessed.||Percentage of symptom-free 24-hr periods||Standard Error|Least Squares Mean
685751|NCT01498653|Secondary|Mean Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods During the 12-week Treatment Period|The number of inhalations of rescue albuterol/salbutamol inhalation aerosol (medication used to relieve symptoms immediately) used during the day and night was recorded by the participants in a daily diary. A 24-hour period in which a participant’s responses to both the morning and evening assessments indicated no use of rescue medication was considered as rescue free. Participants who were rescue free for 24-hour periods during the 12-week Treatment Period were assessed. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline is calculated as the average value during the 12-week Treatment Period minus the value at Baseline. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|Baseline and Weeks 1-12 (up to Day 84)|ITT Population. In addition, the analysis only included participants who had rescue-free 24-hour period data for at least 2 days in the Baseline week prior to randomization and at least 2 days after randomization. Only those participants available at the indicated time point were assessed.||Percentage of rescue-free 24-hr periods||Standard Error|Least Squares Mean
685752|NCT01498653|Secondary|Mean Change From Baseline in Daily Morning (AM) PEF Averaged Over the 12-week Treatment Period|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the value of the averaged daily AM PEF over the 12-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|Baseline and Weeks 1-12 (up to Day 84)|ITT Population. In addition, the analysis only included participants who had PM PEF data for at least 2 days in the Baseline week prior to randomization and at least 2 days after randomization. Only those participants available at the indicated time point were assessed.||L/min||Standard Error|Least Squares Mean
685753|NCT01498653|Primary|Mean Change From Baseline (BL) in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 12-week Treatment Period|Peak Expiratory Flow is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the value of the averaged daily PM PEF over the 12-week Treatment Period minus the Baseline value. Analysis was performed using Analysis of Covariance (ANCOVA) with covariates of Baseline, region, sex, age, and treatment.|Baseline and Weeks 1-12 (up to Day 84)|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received >=1 dose of trial medication. The primary endpoint analysis only included participants who had PM PEF data for >=4 days in the BL week prior to randomization and >=4 days after randomization. Only participants available at the indicated time point were assessed.||Liters/minute (L/min)||Standard Error|Least Squares Mean
685754|NCT01498640|Secondary|Recurrence of Contracture|Recurrence of contracture in the joint at day 365 that was successfully treated 30 days after last injection assessed. Recurrence was defined as 20 degree or greater increase of contracture of the treated joint at day 365 or medication intervention of the treated joint between the 2 time points.|Day 365|Efficacy assessment based on mITT population which includes all enrolled subjects who received at least 1 AA4500 injection to the treated joint and had at least 1 post-injection efficacy measure; only joints that were successfully treated (reduction in contracture to 5 degrees or less) 30 days after last injection were assessed||joints|Joints||Number
685755|NCT01498640|Secondary|Subject Global Assessment of Satisfaction|Subject global assessment of overall treatment satisfaction|30 days after last injection|Efficacy assessment based on mITT population which includes all enrolled subjects who received at least 1 AA4500 injection to the treated joint and had at least 1 post-injection efficacy measure||participants|||Number
685756|NCT01498640|Secondary|Physician Global Assessment of Improvement|Physician global assessment of change (improvement) in subject's Dupuytren's contracture|30 days after last injection|Efficacy assessment based on mITT population which includes all enrolled subjects who received at least 1 AA4500 injection to the treated joint and had at least 1 post-injection efficacy measure||participants|||Number
685757|NCT01498640|Primary|Change in Range of Motion|Range of motion defined as difference between full flexion angle and full extension angle expressed in degrees|Baseline and 30 days after last injection|Efficacy assessment based on mITT population which includes all enrolled subjects who received at least 1 AA4500 injection to the treated joint and had at least 1 post-injection efficacy measure||degrees||Standard Deviation|Mean
685758|NCT01498640|Primary|Percent Change From Baseline in Degree of Contracture|Change in fixed-flection contracture measured in degrees where a decrease of 100% would correspond to a reduction in contracture to 0 degrees|Baseline and 30 days after last injection|Efficacy assessment based on mITT population which includes all enrolled subjects who received at least 1 AA4500 injection to the treated joint and had at least 1 post-injection efficacy measure||percentage of contracture change||Standard Deviation|Mean
685759|NCT01498640|Primary|Clinical Success|Clinical success defined as reduction in fixed-flexion contracture to less than or equal to 5 degrees 30 days after the last injection of AA4500|30 days after last injection|Efficacy assessment based on modified intent-to-treat (mITT) population which includes all enrolled subjects who received at least 1 AA4500 injection to the treated joint and had at least 1 post-injection efficacy measure||percentage of particpants||95% Confidence Interval|Number
685760|NCT01498601|Primary|Hospital Acquired Pneumonia Occurrences|Hospital acquired pneumonia is acquired greater than 48 hours after admission and is diagnosed by a positive chest x-ray plus 2 of the following 3 symptoms: presence of fever, elevated serum white blood cells count, and positive sputum specimen.|10 months|||participants|||Number
685761|NCT01498588|Secondary|Toxicity of Chemotherapy Regimen (Number of Participants With Any Adverse Events)|Toxicity of chemotherapy at each physician visit using Common Toxicity Criteria for Adverse Effects (CTCAE) criteria.|Through 20 weeks of chemotherapy|||participants|||Number
685762|NCT01498588|Primary|Pathologic Complete Response Rate at the Time of Surgery|Patients will receive treatment for 20 weeks with primary outcome measured at the time of surgery. Surgery is typically 4-6 weeks after completion of chemotherapy, so patients will be on study for 24 weeks on average. Response was measured by pathologist’s standard of care assessment of extent of residual disease. If the patient had no evidence of invasive or in situ residual disease present in the breast and lymph node (i.e. ypT0N0), then this was defined as a pathologic complete response (pCR). Reported is the number of participants showing pCR.|Average of 24 weeks|Pathology information at the time of definitive resection was available for six of seven patients. One patient was ultimately lost to follow-up.||participants|||Number
685763|NCT01498575|Primary|Late Driving Performance in On-road Assessment (ODA) Test|The primary outcome was driving performance as measured by the teens completion of the standardized and validated ODA 24 weeks after enrollment. Certified professional driving evaluators blinded to randomization status terminated the ODA if they determined that the teen could not safely complete it. Criteria for termination included: (1) a driver action or inaction requiring evaluator intervention to prevent a collision; (2) a driving task requiring assistance from the evaluator to be performed safely; (3) violation of a traffic law; (4) evasive action needed by another vehicle or a pedestrian to avoid a collision; or (5) a subjective assessment by the evaluator that the teenager could not continue safely. We examined the teens ability to complete the ODA as measured by the number of terminations.|24 weeks after enrollment|512 teen-parent dyads were eligible and agreed to participate. Of these, 217 teens were scheduled to complete the ODA (128 were randomized to Teen Driving Plan (TDP), 89 to Usual Practice). Participant attrition over the time of the study resulted in 151 teens (86 TDP and 65 control) completing the 24-week ODA.||Participants|||Number
685764|NCT01498549|Primary|Rapid Visual Information Processing: Mean Correct Response Latency|Cognitive Test to determine the speed of Visual information. The CANTAB Rapid Visual Information Processing test (RVP) is a measure of sustained attention with a small working memory component (Sahakian and Owen, 1992). Digits are rapidly (100/minute) and pseudo-randomly presented for 7 minutes. Subjects are instructed to press when the third digit of a target sequence (e.g. 3-5-7) is displayed. Primary outcomes are indices of target discriminability (A’) and response bias (B”) and response latency to targets.|2 years|Participants that completed any arm in the crossover are included in the analysis, participants with valid observations at both indices are included in the calculation.||milliseconds||Standard Deviation|Mean
685766|NCT01498458|Secondary|Clinical Benefit Rate (CBR)|To determine the clinical benefit rate (CBR) in patients with measurable disease. CBR consists of complete response , partial response, and stable disease lasting greater than 24 weeks. All patients are included when determining this rate. 2 patients were on study treatment for a long time.Hence the outcome rate of 25 percent ( 2 from 8 patients)|3 years|All patients are included when determining this rate.||percentage of participants|||Number
685767|NCT01498458|Secondary|Objective Response Rate (ORR)|To determine the objective response rate (ORR) in patients with measurable disease. ORR consists of complete response and partial response according to the RECIST criteria. Complete Response refers to the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to less than 10 mm. Partial Response refers to an at least 30 percent decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|3 years|All patients are included when determining this rate.||percentage of participants|||Number
685768|NCT01498458|Secondary|Other Toxicity of the Combination of Pazopanib and Capecitabine||3 years|6 patients experience 6 Serious Adverse Reactions||participants|||Number
685769|NCT01498458|Secondary|Hematological Toxicity of the Combination of Pazopanib and Capecitabine||3 years|||Number of cycles|||Number
685770|NCT01498458|Secondary|Dose-limiting Toxicity (DLT)||3 years|||participants|||Number
685771|NCT01498458|Primary|Maximum Tolerable Dose (MTD) of Pazopanib|The maximum tolerated dose (MTD) is defined as the highest dose level with DLT in no more than 1 out of 6 patients. A maximal tolerated dose (MTD) could not be established.|3 years|||mg|||Number
685772|NCT01498419|Secondary|Percentage of Patients With Sputum Culture Conversion at 8 Weeks on Liquid Media|Sputum culture conversion is defined as a change from a positive growth of M. tuberculosis in a sputum sample to negative M. tuberculosis growth sputum sample in patients with pulmonary TB. This was measured at visit 24(Day 57).|Day 57 after eight weeks of daily treatment|The efficacy analysis population contained participants included in the safety analysis population for whom efficacy data were available and who had no major protocol violations that could affect the integrity of the efficacy data. Participants included in this outcome had a valid, non-contaminated culture from the sample acquired on Day 57.||percentage of patients|||Number
685773|NCT01498419|Secondary|Time to Sputum Conversion Using Data From Weekly Cultures Through 8 Weeks on Solid Media|Sputum culture conversion is defined as a change from a positive growth of M. tuberculosis in a sputum sample to negative M. tuberculosis growth sputum sample in patients with pulmonary TB|8 weeks|The efficacy analysis population contained patients included in the safety analysis population for whom efficacy data were available and who had no major protocol violations that could affect the integrity of the efficacy data. The number of participants analyzed for this outcome was 206.||days||Inter-Quartile Range|Median
685774|NCT01498419|Secondary|Percentage of Participants Who Discontinue Due to an Adverse Event in Each Experimental Arm.||8 weeks|The Safety population was analyzed for this outcome.||percentage of participants|||Number
685775|NCT01498419|Secondary|The Rate of Change in Time to Sputum Culture Positivity (TTP) Through 8 Weeks in the MGIT System in Sputum Over 8 Weeks in Participants as Derived From a Non-linear Regression Model.|Measurement of TTP in liquid culture media Mycobacteria growth indicator tube (MGIT) using standard procedures|8 weeks|The efficacy analysis population contained patients included in the safety analysis population for whom efficacy data were available and who had no major protocol violations that could affect the integrity of the efficacy data. The number of participants analyzed for this outcome was 179.||log10hours/day||95% Confidence Interval|Mean
685776|NCT01498419|Secondary|Percentage of Patients With Sputum Culture Conversion at 8 Weeks on Solid Media|Sputum culture conversion is defined as a change from a positive growth of M. tuberculosis in a sputum sample to negative M. tuberculosis growth sputum sample in patients with pulmonary TB. (Day 57)|Day 57 after eight weeks of daily treatment|The efficacy analysis population contained participants included in the safety analysis population for whom efficacy data were available and who had no major protocol violations that could affect the integrity of the efficacy data. Participants included in this outcome had a valid, non-contaminated culture from the sample acquired on Day 57.||percentage of participants|||Number
685777|NCT01498419|Secondary|Time to Sputum Conversion Using Data From Weekly Cultures Through 8 Weeks on Liquid Media|liquid culture = Mycobacteria growth indicator tube (MGIT) Sputum culture conversion is defined as a change from a positive growth of M. tuberculosis in a sputum sample to negative M. tuberculosis growth sputum sample in patients with pulmonary TB|8 weeks|The efficacy analysis population contained participants included in the safety analysis population for whom efficacy data were available and who had no major protocol violations that could affect the integrity of the efficacy data. The number of participants included for this outcome was 206.||days||Inter-Quartile Range|Median
685778|NCT01498419|Primary|The Rate of Change in Colony Forming Units (CFUs) Using Non-linear Mixed Effects Modeling of the Serial Sputum Colony Counts (SSCC) Over 8 Weeks of Treatment.|The primary efficacy endpoint was bactericidal activity characterized by the daily rate of change in mean log10CFU counts during 8 weeks of treatment (bactericidal activity assessed by CFU on solid media for days 0–56).|8 weeks|The efficacy analysis population contained patients included in the safety analysis population for whom efficacy data were available and who had no major protocol violations that could affect the integrity of the efficacy data. The number of participants analyzed for this outcome was 173.||log10CFU/ml/day||95% Confidence Interval|Mean
685779|NCT01498185|Secondary|Pharmacokinetic Parameters on Day 7 - Ratio of Metabolite (RM) to Parent AUC[TAU]|Serial blood samples were collected predose 0 hr, and hr 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 in the double-blind period. Individual subject PK parameter values were derived by non-compartmental methods by a validated PK analysis program, Kinetica®. Actual sampling times were used for PK calculations and nominal times were used for generation of mean plasma concentration-time plots and summaries. Pre-dose sample collection times were changed from negative numbers (based on elapsed time to dose) to zero for the purpose of calculating PK parameters. The concentrations below the lower limit of quantitation (<LLOQ) were set as “missing” for the calculation of PK parameters as well as summary statistics. MR was calculated as the ratio of metabolite to parent AUC(TAU), corrected for molecular weights of dapagliflozin and dapagliflozin 3-O-glucuronide (408.82 and 584.99, respectively).|Day 7 (0 hr to 24 hr post dose)|Randomized subjects who took at least one dose of dapagliflozin with adequate pharmacokinetic parameter profiles||(ng*h/mL):(ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
685780|NCT01498185|Secondary|Dapagliflozin 3-O-glucuronide Pharmacokinetic Parameters on Day 7 - Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU])|Serial blood samples were collected predose 0 hr, and hr 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 in the double-blind period. Individual subject PK parameter values were derived by non-compartmental methods by a validated PK analysis program, Kinetica®. Actual sampling times were used for PK calculations and nominal times were used for generation of mean plasma concentration-time plots and summaries. Pre-dose sample collection times were changed from negative numbers (based on elapsed time to dose) to zero for the purpose of calculating PK parameters. The concentrations below the lower limit of quantitation (<LLOQ) were set as “missing” for the calculation of PK parameters as well as summary statistics. AUC[TAU], was calculated by a mixture of logand linear-trapezoidal summations.|Day 7 (0 hr to 24 hr post dose)|Randomized subjects who took at least one dose of dapagliflozin with adequate pharmacokinetic parameter profiles||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
685781|NCT01498185|Secondary|Dapagliflozin 3-O-glucuronide Pharmacokinetic Parameters on Day 7 - Time of Maximum Observed Plasma Concentration (Tmax)|Serial blood samples were collected predose 0 hr, and hr 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 in the double-blind period. Individual subject PK parameter values were derived by non-compartmental methods by a validated PK analysis program, Kinetica®. Actual sampling times were used for PK calculations and nominal times were used for generation of mean plasma concentration-time plots and summaries. Pre-dose sample collection times were changed from negative numbers (based on elapsed time to dose) to zero for the purpose of calculating PK parameters. The Tmax was recorded directly from experimental observations.|Day 7 (0 hr to 24 hr post dose)|Randomized subjects who took at least one dose of dapagliflozin with adequate pharmacokinetic parameter profiles||hour||Full Range|Mean
685782|NCT01498185|Secondary|Dapagliflozin 3-O-glucuronide Pharmacokinetic Parameters on Day 7 - Maximum Observed Plasma Concentration (Cmax)|Serial blood samples were collected predose 0 hr, and hr 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 in the double-blind period. Individual subject PK parameter values were derived by non-compartmental methods by a validated PK analysis program, Kinetica®. Actual sampling times were used for PK calculations and nominal times were used for generation of mean plasma concentration-time plots and summaries. Pre-dose sample collection times were changed from negative numbers (based on elapsed time to dose) to zero for the purpose of calculating PK parameters. The Cmax was recorded directly from experimental observations.|Day 7 (0 hr to 24 hr post dose)|Randomized subjects who took at least one dose of dapagliflozin with adequate pharmacokinetic parameter profiles||ng/mL||Geometric Coefficient of Variation|Geometric Mean
685783|NCT01498185|Secondary|Dapagliflozin Pharmacokinetic Parameters on Day 7 - Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU])|Serial blood samples were collected predose 0 hr, and hr 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 in the double-blind period. Individual subject PK parameter values were derived by non-compartmental methods by a validated PK analysis program, Kinetica®. Actual sampling times were used for PK calculations and nominal times were used for generation of mean plasma concentration-time plots and summaries. Pre-dose sample collection times were changed from negative numbers (based on elapsed time to dose) to zero for the purpose of calculating PK parameters. The concentrations below the lower limit of quantitation (<LLOQ) were set as “missing” for the calculation of PK parameters as well as summary statistics. AUC[TAU], was calculated by a mixture of logand linear-trapezoidal summations.|Day 7 (0 hr to 24 hr post dose)|Randomized subjects who took at least one dose of dapagliflozin with adequate pharmacokinetic parameter profiles||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
685784|NCT01498185|Secondary|Dapagliflozin Pharmacokinetic Parameters on Day 7 - Time of Maximum Observed Plasma Concentration (Tmax)|Serial blood samples were collected predose 0 hr, and hr 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 in the double-blind period. Individual subject PK parameter values were derived by non-compartmental methods by a validated PK analysis program, Kinetica®. Actual sampling times were used for PK calculations and nominal times were used for generation of mean plasma concentration-time plots and summaries. Pre-dose sample collection times were changed from negative numbers (based on elapsed time to dose) to zero for the purpose of calculating PK parameters. The Tmax was recorded directly from experimental observations.|Day 7 (0 hr to 24 hr post dose)|Randomized subjects who took at least one dose of dapagliflozin with adequate pharmacokinetic parameter profiles||hour||Full Range|Mean
685785|NCT01498185|Secondary|Dapagliflozin Pharmacokinetic Parameters on Day 7 - Maximum Observed Plasma Concentration (Cmax)|Serial blood samples were collected predose 0 hr, and hr 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 in the double-blind period. Individual subject PK parameter values were derived by non-compartmental methods by a validated PK analysis program, Kinetica®. Actual sampling times were used for PK calculations and nominal times were used for generation of mean plasma concentration-time plots and summaries. Pre-dose sample collection times were changed from negative numbers (based on elapsed time to dose) to zero for the purpose of calculating PK parameters. The Cmax was recorded directly from experimental observations.|Day 7 (0 hr to 24 hr post dose)|Randomized subjects who took at least one dose of dapagliflozin with adequate pharmacokinetic parameter profiles||ng/mL||Geometric Coefficient of Variation|Geometric Mean
685786|NCT01498185|Primary|Mean Change From Baseline in 7-Point Glucose Monitoring (7-PGM) at Day 7|7-PGM was measured as milligrams per deciliter (mg/dL) by a central laboratory. Baseline was defined as the assessment on Day -1, prior to the start date and time of the first dose of the double-blind study medication. 7-PGM included the average of all available glucose values before and 2-hour (hr) after each meal (breakfast, lunch, dinner) as well as bedtime. Measurements were on Day -1, and Day 7 in the double-blind period.|From Baseline to Day 7|All randomized participants who received study medication and had nonmissing values at baseline and Day 7||mg/dL||Standard Error|Mean
685787|NCT01498120|Primary|Number of Subjects With At Least One Adverse Event (AE) From Visit 1 (Day 1) to End of Study|An Adverse Event is any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|From Visit 1 (Day 1) through End of Study (approximately 2 years)|All enrolled subjects who received at least 1 dose of study medication were included in the SS.||subjects|||Number
685788|NCT01498120|Primary|Number of Subjects Withdrawn Due to An Adverse Event (AE) From Visit 1 (Day 1) Through End of Study|An Adverse Event is any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|Visit 1 (Day 1) through End of Study (approximately 2 years)|All enrolled subjects who received at least 1 dose of study medication were included in the SS.||subjects|||Number
685789|NCT01498068|Secondary|Number of Participants in Each Specific Category of Treatment Outcome|Participants were evaluated for following 4 categories of treatment outcome;Sustained Virologic Response 12 Weeks After Last Planned Dose of Study Medication(SVR12):hepatitis C virus (HCV)ribonucleic acid (RNA)<25 IU/mL(target not detected)12 weeks after last planned dose of study medication;Relapse:HCV RNA =>25 IU/mL during follow-up period after previous HCV RNA<25 IU/mL at planned end of treatment(EOT)[Week 24 or Week 48] and participant did not achieve SVR12planned;On treatment virologic failure:meeting virologic stopping rule and/or having detectable HCV RNA at EOT with viral breakthrough(having a confirmed increase >1 log 10 in HCV RNA level from the lowest level reached or confirmed value of HCV RNA >100 IU/mL in participants whose HCV RNA has previously become <25 IU/mL during treatment).Stopping rule defined as HCV RNA value >1000 IU/mL at Week 4, 8 or 12 or detectable HCV RNA at Week 24, 32 or 40;Other:HCV RNA <25 IU/mL at actual EOT and never HCV RNA =>25 IU/mL thereafter.|From Day 1 (Baseline) up to Follow-up visit (Week 36 or Week 60)|Full analysis (FA) population: All participants who received at least one dose of the study medication.||Participants|||Number
685790|NCT01498068|Secondary|Number of Participants With Virologic Failure|Virologic failure is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) levels more than 1,000 IU/mL at Weeks 4, 8, 12, 24, 32, or 40.|Week 4, Week 8, Week 12, Week 24, Week 32, or Week 40|Full analysis (FA) population: All participants who received at least one dose of the study medication.||Participants|||Number
685791|NCT01498068|Secondary|Number of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Less Than 25 IU/mL, (Target Not Detected) at Weeks 8, 12, 24, 32, 40 and 48|The table below shows number of participants with HCV RNA Less than 25 IU/mL, (target not detected) at Weeks 8, 12, 24, 32, 40 and 48. Only 3 treatment-naive and 14 Treatment-experienced participants were assigned to receive study treatment after Week 24. Only participants still receiving Treatment were assessed at 32, 40, and 48 weeks.|Weeks 8, 12, 24, 32, 40 and 48|"Full analysis (FA) population: All participants who received at least one dose of the study medication. n signifies number of participants who were evaluable at each specified timepoint for each arm, respectively."||Participants|||Number
685792|NCT01498068|Secondary|Number of Participants With Rapid Virologic Response (RVR) at Week 4|A RVR is defined as having hepatitis C virus (HCV) ribonucleic acid (RNA) less than 25 IU/mL, (target not detected) at Week 4|Week 4|Full analysis (FA) population: All participants who received at least one dose of the study medication.||Participants|||Number
685793|NCT01498068|Secondary|Median Change in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)|Changes from baseline in log10 HCV RNA levels were calculated.|Baseline (Week 0), Week 4, Week 8, Week 12, Week 24, Week 32, Week 40, and Week 48|"Full analysis (FA) population: All participants who received at least one dose of the study medication. n signifies number of participants who were evaluable at each specified timepoint for each arm, respectively."||Log 10 IU/mL||Full Range|Median
685794|NCT01498068|Primary|Number of Participants With Extended Rapid Virologic Response (eRVR)|A eRVR is defined as having hepatitis C virus (HCV) ribonucleic acid (RNA) less than 25 IU/mL, (target not detected) at Weeks 4 and 12 of treatment.|Week 4 and Week 12|Full analysis (FA) population: All participants who received at least one dose of the study medication.||Participants|||Number
685795|NCT01497938|Primary|The Event Area Under the Curve (AUC) Was Used to Demonstrate the Reduction of Nocturnal Hypoglycemia With the Low Glucose Suspend (LGS) Feature (LGS ON)|An event is identified as: LGS feature in the correct setting; CGM values <= 65 mg/dL continuously with starting time between 10pm - 8am; No evidence of patient intervention during the first 20 minutes when CGM value was <= 65 mg/dL; The rate of change before reaching sensor glucose value of <= 65 mg/dL was <= 5 mg/dl/minutes; If the time between two successive events was less than 30 minutes, they will be combined as one event; An evaluable event is defined as any event with CGM value <= 65 mg/dL of greater than 20 minutes and the LGS feature is on the correct setting; Event AUC analysis was performed based on logarithm of AUC data.|5 months|||mg/dL x min||Standard Deviation|Mean
685796|NCT01497938|Primary|Change in A1C From Baseline to End of Study Participation|The first study objective is to demonstrate that home use of Low Glucose Suspend (LGS) is safe and is not associated with glycemic deterioration, as measured by change in A1C from baseline to end of study participation.|5 months|||Percent||Standard Deviation|Mean
685797|NCT01497899|Secondary|Change From Baseline in CD4+ Cell Count at Weeks 24 and 48||Baseline; Weeks 24 and 48|Participants in Full Analysis Set with available data were analyzed.||cells/uL||Standard Deviation|Mean
685798|NCT01497899|Secondary|Change From Baseline in log10 HIV-1 RNA at Weeks 24 and 48||Baseline; Weeks 24 and 48|Participants in Full Analysis Set with available data were analyzed.||log10 copies/mL||Standard Deviation|Mean
685799|NCT01497899|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Full Analysis Set||percentage of participants|||Number
685800|NCT01497899|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 24|Full Analysis Set: participants randomized to the Double-Blind Phase and received at least 1 dose of study drug.||percentage of participants|||Number
685801|NCT01497756|Secondary|Side Effects|Any recorded complications|Eight months|All patients||participants|||Number
685802|NCT01497756|Primary|Usage|Number of patients on whom CAPP is used|Eight months|Entire number of participants||participants|||Number
685803|NCT01497665|Secondary|Six Month Overall Survival||Upon enrollment through end of study period (1 year after last patient is enrolled)|Once the study was terminated, no further survival data was collected and there was insufficient number of participants with data collected for this outcome measure.|||||
685804|NCT01497665|Secondary|Duration of Overall Progression Free Survival||Upon enrollment through end of study period (1 year after last patient is enrolled)|Once the study was terminated, no further efficacy data was collected and there was insufficient number of participants with data collected for this outcome measure.|||||
686349|NCT01490931|Secondary|The Median Onset of First Perceptible Pain Relief of Intranasal Ketorolac in Dental Implant Surgery Patients|Data will be obtained employing the well-described double stop watch technique|Censored at 6 hours|||seconds||95% Confidence Interval|Median
685807|NCT01497665|Primary|Overall (Intra-cranial and Extra-cranial) Objective Response Rate in Non-small Cell Lung Cancer (NSCLC) Patients With Brain Metastasis|Tumor response was assessed by Gd-MRI for intracranial lesions and CT/MRI with contrast of chest, abdomen, pelvis for extracranial lesions using modified OVERALL RECIST v1.1 as follows: Complete Response (CR), disappearance of all target and non-target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions and non-target lesions stable or decreased; Stable Disease (SD), < 30% decrease but <20% increase in target lesions and non-target lesions stable or decreased; Progressive disease (PD), >= 20% (>= 5 mm) increase in the sum of diameters of the target lesions, taking as reference the smallest sum on study, non-target lesions increased or appearance of a new lesion; Overall Response (OR) = CR + PR.|upon enrollment through end of study period (1 year after last patient is enrolled)|||participants|||Number
685808|NCT01497366|Secondary|Percentage of Participants With Viral Relapse Following Treatment|Viral relapse was defined as HCV RNA ≥ 25 IU/mL in post-treatment after having achieved < LLOQ at last on-treatment measurement, confirmed with 2 consecutive values or last available measurement.|Up to Post-treatment Week 24|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants|||Number
685809|NCT01497366|Secondary|Percentage of Participants With Virologic Failure During Treatment|"Virologic failure was defined as either
Viral breakthrough: HCV RNA ≥ 25 IU/mL after having previously had HCV RNA < 25 IU/mL while on treatment, confirmed with 2 consecutive values or last available measurement
Viral rebound: > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values or last available measurement
Non-response: HCV RNA persistently ≥ 25 IU/ml while on treatment (through Week 12)"|Baseline up to Week 24|Full Analysis Set||percentage of participants|||Number
685810|NCT01497366|Secondary|Change From Baseline in HCV RNA||Baseline to Week 12|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
685811|NCT01497366|Secondary|Percentage of Participants With HCV RNA < LLOQ on Treatment||Up to 12 Weeks|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants|||Number
685812|NCT01497366|Secondary|Percentage of Participants With Sustained Virologic Response 24 Weeks After Stopping All Study Drugs (SVR24)|SVR24 was defined as HCV RNA < LLOQ 24 weeks after study drug cessation.|Post-treatment Week 24|Full Analysis Set||percentage of participants|||Number
685813|NCT01497366|Secondary|Number of Participants Who Experienced Adverse Events (AEs) and Graded Laboratory Abnormalities||Up to 24 weeks plus 30 days following the last dose of study drug|Safety Analysis Set||participants|||Number
685814|NCT01497366|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Stopping All Study Drugs (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; < 25 IU/mL) 12 weeks after study drug cessation.|Post-treatment Week 12|Full Analysis Set||percentage of participants|||Number
685815|NCT01497275|Secondary|Overall Survival at 5 Year|Number of participants who were alive at the 5 year time point. (Overall survival will be defined as the time from on-study to death due to any cause.)|5 year|No analysis completed due to study being terminated prior to the 5 year time point.|||||
685816|NCT01497275|Secondary|Overall Survival at 1 Year|Number of participants who were alive at the 1 year time point. (Overall survival will be defined as the time from on-study to death due to any cause.)|1 year|1 subject did not reach the one year evaluation because the study was terminated.||participants|||Number
685817|NCT01497275|Secondary|Number of Participants With Progression Free Survival|Progression-free survival will be defined as time from on-study to disease progression or death, whichever comes first|6 months|Only 3 subjects provided evaluable data at the 6 month time point. 2 subjects did not reach this time-point so they were not assessed for progression||participants|||Number
685818|NCT01497275|Primary|Response Rate (Complete Response + Partial Response)|"Disease will be assessed every 3 months.
The Cheson criteria will be used to define response:
Complete Response = Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present prior to therapy.
Partial Response = A decrease of ≥ 50% in the sum of the products of their greatest transverse diameters (SPD) of up to six of the largest dominant nodes or nodal masses. These nodes or masses should be selected according to the following features: a) they should be clearly measurable in at least two perpendicular measurements; b) they should be from as disparate regions of the body as possible; and c) they should include mediastinal and retroperitoneal areas of disease whenever these sites are involved."|3 months|Only 3 subjects completed the drug regimen; 1 subject did not complete due to disease progression; 1 did not complete due to adverse event.||participants|||Number
685819|NCT01497262|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Any Adverse Event was defined as occurrence of any symptom regardless of intensity grade, Serious Adverse Event (SAEs) assessed as medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in persistent or significant disability/incapacity|28 weeks|Safety set includes all patients who received at least one dose of study drug||Participants|||Number
685820|NCT01497262|Secondary|Number (%) of Patients With AE of Special Interest Including Bradyarrhythmia, BP Increase, Liver Transaminase Elevations, Infections , Macula Oedema.|The incidence of events in special areas of safety interest (including bradyarrhythmias, BP increase, liver function, infections and macular oedema) were assessed by the nature and frequency of AE reporting. These areas of special interest have been identified and potential risks of fingolimod based on knowledge from clinical trials and post-marketing reporting.|4 months|Safety set includes all patients who received at least one dose of study drug||Percent of Participants|||Number
685821|NCT01497197|Secondary|Number of Subjects With Any Adverse Events (AEs), Serious AEs, AEs Leading to Death, and AEs Leading to Discontinuation|An AE was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A serious AE is an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.|Baseline up to 15-20 days post r-hCG administration|Safety population included all randomized subjects who received at least one dose of the trial treatment.||subjects|||Number
686532|NCT01489189|Secondary|Mean Change in OCT Central Subfield Thickness From Baseline|All baseline and 2-year optical coherence tomography (OCT) scans were evaluated by the OCT reading center.|2-years|Eyes with optical coherence tomography (OCT) data at baseline and 2-years.||µm|Eyes|95% Confidence Interval|Mean
685822|NCT01497197|Secondary|Number of Subjects With Multiple Pregnancies|Multiple pregnancy was defined as the existence of more than one ultrasound confirmed gestational sac in the uterus with fetal heart activity at post-r-hCG Days 35–42.|35 to 42 days post r-hCG administration|MITT included all subjects randomized into trial who received at least 1 dose of Gonal-f® or Luveris®, and completed the primary efficacy assessment (total number of oocytes retrieved per subject following r-hFSH stimulation and r-hCG injection). ‘N’=signifies all subjects who showed positive pregnancy test and evaluable for this outcome measure.||subjects|||Number
685823|NCT01497197|Secondary|Number of Subjects With Biochemical Pregnancies|Biochemical pregnancy was defined as the pregnancy diagnosed only by the detection of hCG in serum or urine and that does not develop into a clinical pregnancy. Subjects with beta-hCG concentration greater than 10 IU/L were considered as biochemical pregnant.|35 to 42 days post r-hCG administration|MITT included all the subjects randomized into the trial who received at least 1 dose of Gonal-f® or Luveris®, and who completed the primary efficacy assessment (total number of oocytes retrieved per subject following r-hFSH stimulation and r-hCG injection).||subjects|||Number
685824|NCT01497197|Secondary|Cycle Cancellation Rate Prior to r-hCG|If the subject was not administered with r-hCG and withdrew prematurely from the trial, it was considered as cycle cancellation.|Up to 85 days|MITT included all the subjects randomized into the trial who received at least 1 dose of Gonal-f® or Luveris®, and who completed the primary efficacy assessment (total number of oocytes retrieved per subject following r-hFSH stimulation and r-hCG injection).||percentage of subjects|||Number
685825|NCT01497197|Secondary|Total Pregnancy Rate and Clinical Pregnancy Rate|The subject was considered to have a positive pregnancy result if beta-hCG >10 international units per liter (IU/L) and the subject had not menstruated between post-r-hCG Days 15–20. Clinical pregnancy was defined as the existence of at least an US confirmed gestational sac in the uterus with fetal heart activity post-r-hCG Days 35–42.|35-42 days post r-hCG administration|MITT included all the subjects randomized into the trial who received at least 1 dose of Gonal-f® or Luveris®, and who completed the primary efficacy assessment (total number of oocytes retrieved per subject following r-hFSH stimulation and r-hCG injection).||percentage of subjects|||Number
685826|NCT01497197|Secondary|Number of Fetal Sacs With Detectable Heart Beats|Number of fetal sacs with detectable heart beats was evaluated by US on Days 35-42 post r-hCG to confirm clinical pregnancy|35-42 days post r-hCG administration|MITT included all subjects randomized in the trial who received at least 1 dose of Gonal-f® or Luveris®, and who completed primary efficacy assessment(total number of oocytes retrieved/subject following r-hFSH stimulation and r-hCG injection). 'N' signifies all participants who showed positive pregnancy test and evaluable for this outcome measure.||Fetal sacs||Standard Deviation|Mean
685827|NCT01497197|Secondary|Number of Fetal Sacs With Activity|Number of fetal sacs with activity was evaluated by ultrasound scan (US) on Days 35–42 post r-hCG to confirm clinical pregnancy.|35-42 days post r-hCG administration|MITT included all subjects randomized in the trial who received at least 1 dose of Gonal-f® or Luveris®, and who completed primary efficacy assessment(total number of oocytes retrieved/subject following r-hFSH stimulation and r-hCG injection). 'N' signifies all participants who showed positive pregnancy test and evaluable for this outcome measure.||Fetal sacs||Standard Deviation|Mean
685828|NCT01497197|Secondary|Implantation Rate|The implantation rate was determined as number of fetal sacs divided by the number of embryos transferred post r-hCG administration.|35-42 days post r-hCG administration|MITT included all subjects randomized in the trial who received at least 1 dose of Gonal-f® or Luveris®, and who completed primary efficacy assessment(total number of oocytes retrieved/subject following r-hFSH stimulation and r-hCG injection). 'N' signifies all subjects who showed positive pregnancy test and evaluable for this outcome measure.||fetal sacs/embryo transferred||Standard Deviation|Mean
685829|NCT01497197|Secondary|Total Number of Stimulation Treatment Days|The total number of stimulation treatment days for each subject was determined based on the treatment administration information collected in the case report form.|6 days post stimulation (Number of stimulation days+6 days)|MITT included all the subjects randomized into the trial who received at least 1 dose of Gonal-f® or Luveris®, and who completed the primary efficacy assessment (total number of oocytes retrieved per subject following r-hFSH stimulation and r-hCG injection).||days||Standard Deviation|Mean
685830|NCT01497197|Secondary|Total Dose and Mean Daily Dose of Follicle Stimulating Hormone (FSH)|Mean daily dose of FSH was to be determined by dividing the total daily dose by the number of stimulation days.|Screening|Data was not analysed as per planned analysis due to frequent protocol violations/deviations, there was no subject eligible to be analyzed per protocol.|||||
685831|NCT01497197|Primary|Total Number of Oocytes Retrieved Per Subject Following Ovarian Stimulation|Ovarian stimulation was performed using in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI). The total number of oocytes collected per subject following stimulation was reported.|34-38 hours post r-hCG administration|Modified intention-to-treat (MITT) included all the subjects randomized into the trial who received at least 1 dose of Gonal-f® or Luveris®, and who completed the primary efficacy assessment (total number of oocytes retrieved per subject following recombinant human follicle stimulating hormone (r-hFSH) stimulation and r-hCG injection).||oocytes||Standard Deviation|Mean
685832|NCT01497171|Primary|Comparison of the Proportion of Subjects in Each Group, Who Achieve Anatomic Success at 12 Month Follow-up.|Anatomical success will be measured using a composite index including: lack of specific prolapse symptoms, no interval treatment and no observed prolapse beyond 1 cm from the hymen.|12 months|No analysis was done due to early termination of the study.|||||
685960|NCT01495858|Secondary|Karolinska Sleep Diary - Ease of Awakening|Subjects responded to the following question: Ease of awakening? (1) very difficult; (2) rather difficult; (3) neither difficult nor easy; (4) rather easy; very easy (5)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)||Participants|||Number
685835|NCT01496807|Other Pre-specified|Count of Participants Developing Positive Autoantibody Screen|"Number of participants who developed a positive result during treatment for one or more antibodies of a previously negative screen.
This study was not designed to statistically test the efficacy of treatment, and no inferential analyses will be performed. Investigators planned to look for evidence of serologic and clinical autoimmunity."|Up to 54 Months|All evaluable participants||Participants|||Count of Participants
685836|NCT01496807|Secondary|Treatment Related Adverse Events (AEs) - Grade 3 to 5|Percentage of participants with treatment related AEs, Grade 3 to 5. All adverse events, regardless of causality are also reported in the Serious Adverse Event/Other Adverse Event reporting area.|4 Years, 1 Month|All Participants||Participants|||Count of Participants
685837|NCT01496807|Secondary|Overall Survival (OS)|OS: The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive.|Up to 54 Months|All evaluable participants||months||95% Confidence Interval|Median
685838|NCT01496807|Secondary|Progression Free Survival (PFS)|Immune Related Progressive Disease (irPD): increase in tumor burden >25% relative to nadir (minimum recorded tumor burden) confirmed by repeat consecutive assessment at least 4 weeks later.|Up to 54 Months|All evaluable participants||months||95% Confidence Interval|Median
685839|NCT01496807|Secondary|Number of Participants With Overall Response (OR)|Overall Response: Complete Response (CR) + Partial Response (PR) by immune-related response criteria (irRC). Immune Related CR (irCR): Complete disappearance of all lesions (whether measurable or not, and no new lesions, and confirmation by a repeat consecutive assessment no less than 4 weeks from date first documented. Immure Related PR (irPR): decrease in tumor burden >50% relative to baseline confirmed by repeat consecutive assessment at least 4 weeks later.|Up to 54 Months|All evaluable participants||Participants|||Count of Participants
685840|NCT01496807|Primary|Maximum Tolerated Dose (MTD) of Ipilimumab|MTD of Ipilimumab (Yervoy) combined with peginterferon alfa-2b (Sylatron). To assess the safety, toxicities and tolerability of a regimen of 3 μg/kg weekly Sylatron with concurrent induction Yervoy at 3 mg/kg, then if well tolerated, at 10 mg/kg every three weeks four times, in participants with unresectable stages IIIC/IV melanoma, and to define a well tolerated dose of Yervoy in that combination.|Up to 48 Months|All participants||mg/kg|||Number
685841|NCT01496807|Primary|Maximum Tolerated Dose (MTD) of Sylatron|MTD of peginterferon alfa-2b (Sylatron) combined with Ipilimumab (Yervoy).|Up to 48 Months|All participants||μg/kg s|||Number
685842|NCT01496469|Secondary|Change From Baseline in Serum Urate Levels at Week 6||Baseline and Week 6|FAS included all participants who were randomized and received at least 1 dose of double-blind study medication and had a baseline value and at least 1 post-baseline value available, with last observation carried forward.||mg/dL||Standard Error|Least Squares Mean
685843|NCT01496469|Secondary|Change From Baseline in 24-hour Mean Diastolic Blood Pressure (DBP) Measured by Ambulatory Blood Pressure Monitoring at Week 6|The change in 24-hour mean DBP measured at final visit or Week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 6|FAS included all participants who were randomized and received at least 1 dose of double-blind study medication and had a baseline value and at least 1 post-baseline value available, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
685844|NCT01496469|Primary|Change From Baseline in 24-hour Mean Systolic Blood Pressure (SBP) Measured by Ambulatory Blood Pressure Monitoring at Week 6|The change in 24-hour mean SBP measured at final visit or Week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 6|FAS included all participants who were randomized and received at least 1 dose of double-blind study medication and had a baseline value and at least 1 post-baseline value available, with last observation carried forward.||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
685845|NCT01496456|Secondary|Lesion Survival After 3 Years|Discrete time survival analysis of time to first lesion progression.|3 years|Radiographic lesion increase by PWA+DSR. A tooth was included up until the time the lesion first increased.||Lesions|Lesions||Number
685846|NCT01496456|Secondary|Number of Lesions Showing Radiographic Progression as Measured by Lesion Depth Categories|Radiographic assessment of lesion depth category (R1-R5) by single radiograph assessment (SRA).|Baseline through 3 years|||Lesions|Lesions||Number
685847|NCT01496456|Primary|Number of Lesions Showing Radiographic Progression as Measured by Lesion Size (Continuous)|Pairwise radiographic assessment of lesion progression: combined visual assessment (PWA) and digital subtraction radiography (DSR).|Baseline through 3 years|Pairwise assessment: visual (PWA) + digital subtraction radiography (DSR).||Lesions|Lesions||Number
685848|NCT01496430|Secondary|Change From Baseline to Week 6 and Week 24 in AUC for Glucagon During OGTT|The change between the AUC for glucagon at weeks 6 and 24 relative to baseline. AUC will be calculated based on measurements at 0, 30, 60 and 120 minutes. Oral glucose tolerance test measures glucose, insulin, C-peptide, insulin/glucose ratio, and glucagon through blood samples drawn at 0, 30, 60, and 120 minutes following consumption of a 75 g glucose beverage.|Baseline and Weeks 6 and 24|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Observed cases.||ng*hours/L||Standard Error|Least Squares Mean
685849|NCT01496430|Secondary|Change From Baseline to Week 6 and Week 24 in AUC for Insulin/Glucose Ratio During OGTT|The change between the AUC for insulin/glucose ratio at weeks 6 and 24 relative to baseline. AUC will be calculated based on measurements at 0, 30, 60 and 120 minutes. Oral glucose tolerance test measures glucose, insulin, C-peptide, insulin/glucose ratio, and glucagon through blood samples drawn at 0, 30, 60, and 120 minutes following consumption of a 75 g glucose beverage.|Baseline and Weeks 6 and 24|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Observed cases.||pmol*hr/mmol||Standard Error|Least Squares Mean
685879|NCT01496313|Secondary|Time to Objective Response (RECIST 1.1) by Treatment Arm||Randomization to Week 60 (maximum)|Per RECIST v1.1 for target lesions: CR, disappearance of all target lesions; PR, at least a 30% decrease in the sum of diameters of target lesions; Progressive disease (PD), at least 20% increase in the sum of diameters of target lesions; Stable disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD||Months||95% Confidence Interval|Median
686533|NCT01489189|Secondary|Frequency of Vitrectomy||2-years|||eyes|Eyes||Number
685850|NCT01496430|Secondary|Change From Baseline to Week 6 and Week 24 in AUC for C-peptide During OGTT|The change between the AUC for C-peptide at weeks 6 and 24 relative to baseline. AUC will be calculated based on measurements at 0, 30, 60 and 120 minutes. Oral glucose tolerance test measures glucose, insulin, C-peptide, insulin/glucose ratio, and glucagon through blood samples drawn at 0, 30, 60, and 120 minutes following consumption of a 75 g glucose beverage.|Baseline and Weeks 6 and 24|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Observed cases.||nmol*hours/L||Standard Error|Least Squares Mean
685851|NCT01496430|Secondary|Change From Baseline to Week 6 and Week 24 in AUC for Insulin During OGTT|The change between the AUC for insulin at weeks 6 and 24 relative to baseline. AUC will be calculated based on measurements at 0, 30, 60 and 120 minutes. Oral glucose tolerance test measures glucose, insulin, C-peptide, insulin/glucose ratio, and glucagon through blood samples drawn at 0, 30, 60, and 120 minutes following consumption of a 75 g glucose beverage.|Baseline and Weeks 6 and 24|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Observed cases.||pmol*hours/L||Standard Error|Least Squares Mean
685852|NCT01496430|Secondary|Change From Baseline to Week 6 and Week 24 in the Area Under the Plasma Concentration-time Curve (AUC) for Glucose During OGTT|The change between the AUC for glucose at weeks 6 and 24 relative to baseline. AUC will be calculated based on measurements at 0, 30, 60 and 120 minutes. Oral glucose tolerance test measures glucose, insulin, C-peptide, insulin/glucose ratio, and glucagon through blood samples drawn at 0, 30, 60, and 120 minutes following consumption of a 75 g glucose beverage.|Baseline and Weeks 6 and 24|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Observed cases.||mmol*hours/L||Standard Error|Least Squares Mean
685853|NCT01496430|Secondary|Change From Baseline to Week 6 and Week 24 in 2h Glucose During Oral Glucose Tolerance Testing (OGTT)|The change between the glucose value collected at weeks 6 and 24 relative to baseline. Oral glucose tolerance test measures glucose, insulin, C-peptide, insulin/glucose ratio, and glucagon through blood samples drawn at 0, 30, 60, and 120 minutes following consumption of a 75 g glucose beverage.|Baseline and Weeks 6 and 24|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Observed cases.||mmol/L||Standard Error|Least Squares Mean
685854|NCT01496430|Secondary|Change From Baseline in Fasting Plasma Glucose|The change between the fasting plasma glucose value collected at each week indicated relative to baseline.|Baseline and Weeks 2, 4, 6, 8, 12, 16, 20, and 24|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Missing values were imputed using last observation carried forward.||mmol/L||Standard Error|Least Squares Mean
685855|NCT01496430|Secondary|Change From Baseline in HbA1c|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at each week indicated relative to baseline.|Baseline and Weeks 2, 4, 6, 8, 12, 16 and 20|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Missing values were imputed using last observation carried forward.||percentage glycosylated hemoglobin||Standard Error|Least Squares Mean
685856|NCT01496430|Secondary|Time to First Glycemic Rescue|The time to the first instance of participants requiring glycemic rescue during study.|24 Weeks|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication.||Days||Inter-Quartile Range|Median
685857|NCT01496430|Secondary|Percentage of Participants Requiring Rescue Glycemic Therapy|Percentage of participants requiring rescue glycemic therapy during study.|24 Weeks|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication.||percentage of participants|||Number
685858|NCT01496430|Secondary|Change From Baseline in the Trough (22 to 24 Hours After Dosing) Diastolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring|The change in trough diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 8|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Observed cases.||mm Hg||Standard Error|Least Squares Mean
685859|NCT01496430|Secondary|Change From Baseline in the Trough (22 to 24 Hours After Dosing) Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring|The change in trough systolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 8|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Observed cases.||mm Hg||Standard Error|Least Squares Mean
685860|NCT01496430|Secondary|Change From Baseline in the 12-hr Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring|The change in 12-hour mean systolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded during the first 12 hours after dosing.|Baseline and Week 8|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Observed cases.||mm Hg||Standard Error|Least Squares Mean
685861|NCT01496430|Secondary|Change From Baseline in the 12-hr Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring|The change in 12-hour mean systolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded during the first 12 hours after dosing.|Baseline and Week 8|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Observed cases.||mm Hg||Standard Error|Least Squares Mean
685862|NCT01496430|Secondary|Change From Baseline in the Mean Nighttime (12 AM to 6 AM) Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring|The change in nighttime (12am to 6am) mean diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 8|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Observed cases.||mm Hg||Standard Error|Least Squares Mean
685863|NCT01496430|Secondary|Change From Baseline in the Mean Nighttime (12 AM to 6 AM) Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring|The change in nighttime (12am to 6am) mean systolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 8|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Observed cases.||mm Hg||Standard Error|Least Squares Mean
685864|NCT01496430|Secondary|Change From Baseline in the Mean Daytime (6 AM to 10 PM) Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring|The change in daytime (6am to 10pm) mean diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 8|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Observed cases.||mm Hg||Standard Error|Least Squares Mean
685865|NCT01496430|Secondary|Change From Baseline in the Mean Daytime (6 AM to 10 PM) Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring|The change in daytime (6am to 10pm) mean systolic blood pressure measured week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 8|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Observed cases.||mm Hg||Standard Error|Least Squares Mean
685866|NCT01496430|Secondary|Change From Baseline in the 24-hour Mean Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring|The change in 24-hour mean diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 8|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Observed cases.||mm Hg||Standard Error|Least Squares Mean
685867|NCT01496430|Secondary|Change From Baseline in the 24-hour Mean Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring|The change in 24-hour mean systolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 8|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Observed cases.||mm Hg||Standard Error|Least Squares Mean
685868|NCT01496430|Secondary|Change From Baseline in Trough Sitting Clinic Diastolic Blood Pressure|The change in trough diastolic blood pressure measured at week 8 relative to baseline. The trough is the average of the non-missing values of the 3 serial trough sitting diastolic blood pressure measurements.|Baseline and Week 8|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Missing values were imputed using last observation carried forward.||mm Hg||Standard Error|Least Squares Mean
685869|NCT01496430|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 24 relative to baseline.|Baseline and Week 24|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Missing values were imputed using last observation carried forward.||percentage glycosylated hemoglobin||Standard Error|Least Squares Mean
685870|NCT01496430|Primary|Change From Baseline in Trough Sitting Clinic Systolic Blood Pressure|The change in trough systolic blood pressure measured at week 8 relative to baseline. The trough is the average of the non-missing values of the 3 serial trough sitting systolic blood pressure measurements.|Baseline and Week 8|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Missing values were imputed using last observation carried forward.||mm Hg||Standard Error|Least Squares Mean
685871|NCT01496352|Secondary|Incidence of Surgical Site Infection|The incidence of probable or definite surgical site infection as determined by the Investigator.|Up to 30 Days After Surgery|As treated||Participants|||Number
685872|NCT01496352|Secondary|Antibiotic Resistance|Methicillin-resistant Staphylococcus aureus and vancomycin-resistant enterococcus presence at surgery on Day 1 and 5 days after surgery|Baseline up to Day 5|As Treated||Participants|||Number
685873|NCT01496352|Secondary|Renal Function|Changes in serum creatinine from surgery on Day 1 until 14 days after surgery|Baseline up to Day 14|As treated||Participants|||Number
685874|NCT01496352|Secondary|Maximal Plasma Concentration (Cmax)|Maximal plasma concentration (Cmax)of gentamicin and vancomycin using sparse sampling from baseline (DFA-02 application during surgery on Day 1) to 4 days after surgery|1, 6, 24, 48, 96 hours post-dose|All subjects receiving DFA-02 active gel||mcg/mL||Standard Deviation|Mean
685875|NCT01496352|Primary|Area Under Curve (AUC)|Area under the curve (AUC) of plasma gentamicin and vancomycin levels using sparse sampling from baseline (DFA-02 application during surgery on Day 1) to 4 days after surgery|1, 6, 24, 48 96 hours post-dose|All Subjects Receiving Active Drug||mcg/h/mL||Standard Deviation|Mean
685876|NCT01496352|Primary|Number of Patients With Adverse Events, Laboratory, Physical Examination Changes|Safety and tolerability measured by number of patients with adverse events or changes in laboratory or physical examination findings from baseline (DFA-02 application during surgery on Day 1) to 30 days after surgery.|Baseline up to Day 30|As Treated||Participants|||Number
685877|NCT01496313|Secondary|Plasma Concentration of Vandetanib in the Bloodstream (Cmax) for Patients by Treatment Arm.||Week 3 to week 60 (maximum)|All patients who received at least 1 dose of vandetanib and for whom quantifiable plasma concentration data were available.||ng/ml||Standard Deviation|Mean
685878|NCT01496313|Secondary|Percentage Change From Baseline in Target Lesion Size (RECIST 1.1) by Treatment Arm||Randomization to Week 60 (maximum)|Per RECIST v1.1 for target lesions: CR, disappearance of all target lesions; PR, at least a 30% decrease in the sum of diameters of target lesions; Progressive disease (PD), at least 20% increase in the sum of diameters of target lesions; Stable disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD||% change||Standard Deviation|Mean
685880|NCT01496313|Secondary|Duration of Objective Response (RECIST 1.1) by Treatment Arm||Randomization to Week 60 (maximum)|Per RECIST v1.1 for target lesions: CR, disappearance of all target lesions; PR, at least a 30% decrease in the sum of diameters of target lesions; Progressive disease (PD), at least 20% increase in the sum of diameters of target lesions; Stable disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD||Months||95% Confidence Interval|Median
685881|NCT01496313|Secondary|Best Objective Response||Randomisation to week 60 (maximum)|Per RECIST v1.1 for target lesions: CR, disappearance of all target lesions; PR, at least a 30% decrease in the sum of diameters of target lesions; Progressive disease (PD), at least 20% increase in the sum of diameters of target lesions; Stable disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD||Participants|||Number
685882|NCT01496313|Primary|Overall Response Rate (ORR) for Vandetanib 150 and 300mg With Responses Determined by the Investigator|ORR=proportion of patients with a best response of complete or partial response as per Response Evaluation Criteria in Solid Tumors(RECIST)1.1|Randomisation to week 60 (maximum)|Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions; Partial response (PR), at least a 30% decrease in the sum of diameters of target lesions; ORR = CR + PR||Proportion of participants||95% Confidence Interval|Number
685883|NCT01496287|Secondary|Tube Retention|Tube retention is the presence of a tympanostomy tube placed successfully by the Tula TDS device across the tympanic membrane at the two-week follow-up visit.|2 weeks post procedure|Only 62 of the initial 70 subjects achieved procedure success, and were present for 2 week follow-up assessment with Tula tube in situ, such that tube retention could be measured.||ears|Participants||Number
685884|NCT01496287|Secondary|Procedure Tolerability|"Procedure Tolerability is defined as the proportion of subjects reporting the procedure as tolerable, where tolerable is defined as a score of 0 through 3, using the Wong-Baker FACES pain scale.The Wong-Baker FACES pain scoring system is a scale of 0 to 5, where 0 means 'no hurt', 1 = 'hurts a little bit', 2 = 'hurts little more', 3 = 'hurts even more', 4 = 'hurts whole lot' and 5 = 'hurts worst'. Procedure Tolerability will be determined on a per patient basis, with the patient’s score being the average of the scores for the left and right ear if both ears are successfully treated with the Tube Delivery System.
Tolerability was defined as an average post-procedure pain score (of treated ears) <= 3"|Day 0 (day of procedure)|||participants|||Number
685885|NCT01496287|Secondary|Procedure Success|Procedure Success is defined as the successful placement of any tympanostomy tube in all enrolled ears in a given subject. Procedure Success is determined on a per subject basis.|Day 0 (day of procedure)|||participants|||Number
685886|NCT01496287|Primary|Device Success|Device Success is defined as the successful delivery of the tympanostomy tube (TT) across the tympanic membrane (TM) using the Tube Delivery System(TDS). Device Success will be evaluated on a per device basis.|Day 0 (day of procedure)|Analysis population includes subjects who had completed the local anesthesia procedure (iontophoresis) and in which a TDS tube delivery device was attempted.||devices|Participants||Number
685887|NCT01496287|Primary|Number of Participants With Procedural, Serious, and Device-Related Adverse Events|Adverse events which are procedural, serious, and device-related.|procedure up to 2 weeks post procedure|||participants|||Number
685888|NCT01496274|Secondary|Annualized Spontaneous Bleeding Events Compared Between 7 Day Prophylactic and Extended Regimens|Median number of spontaneous bleeds per year per subject comparing 7-, 10- and 14- day prophylactic regimens.|During treatment, between median 240 and 386 days per subject.|Efficacy Population||bleeds/year/subject||Inter-Quartile Range|Median
685889|NCT01496274|Secondary|Investigator’s (or Surgeon’s) Overall Clinical Assessment of Hemostatic Efficacy for Surgical Prophylaxis, Based on a Four Point Ordinal Scale (Excellent, Good, Moderate, Poor/No Response)|Number of surgical events treated prophylactically with rIX-FP that resulted in hemostatic efficacy of excellent, good, moderate, poor/no response, according to the Investigator’s (surgeon’s) overall assessment of hemostatic efficacy for surgical prophylaxis.|Up to 14 days after surgery|Surgical Population||events|Participants||Number
685890|NCT01496274|Secondary|Clearance of a Single Dose of rIX-FP|PK data are presented for a single 50 IU/kg dose of rIX-FP.|336 hours|The PK population comprised 46 subjects who received at least 1 dose of rIX-FP at 50 IU/kg. Data are presented for subjects from the PK population who had a sufficient number of analyzable PK samples for evaluation of the PK profile of rIX-FP.||mL/hr||Standard Deviation|Mean
685891|NCT01496274|Secondary|Area Under the Curve (AUC)|AUC to the last sample with quantifiable drug concentration (AUClast) of a single dose of rIX-FP. PK data are presented for a single 50 IU/kg dose of rIX-FP.|336 hours|The PK population comprised 46 subjects who received at least 1 dose of rIX-FP at 50 IU/kg. Data are presented for subjects from the PK population who had a sufficient number of analyzable PK samples for evaluation of the PK profile of rIX-FP.||IU*hr/dL||Standard Deviation|Mean
685892|NCT01496274|Secondary|Half-life (t1/2) of a Single Dose of rIX-FP|PK data are presented for a single 50 IU/kg dose of rIX-FP.|336 hours|The PK population comprised 46 subjects who received at least 1 dose of rIX-FP at 50 IU/kg. Data are presented for subjects from the PK population who had a sufficient number of analyzable PK samples for evaluation of the PK profile of rIX-FP.||hour||Standard Deviation|Mean
685893|NCT01496274|Secondary|Incremental Recovery of rIX-FP|Pharmacokinetic (PK) data are presented for a single 50 IU/kg dose of rIX-FP.|336 hours|The PK population comprised 46 subjects who received at least 1 dose of rIX-FP at 50 IU/kg. Data are presented for subjects from the PK population who had a sufficient number of analyzable PK samples for evaluation of the PK profile of rIX-FP.||(IU/dL)/(IU/kg)||Standard Deviation|Mean
685894|NCT01496274|Secondary|rIX-FP Consumed Per Month While Maintaining Assigned Prophylactic Treatment Interval During Routine Prophylaxis.|Time frame: For Prophylaxis Arm 7-, 10- and 14-day regimens, median 269, 240 and 386 days respectively. For On-demand Arm, prophylaxis regimen, median 316 days.|Median 269, 240, 386 and 316 days, respectively (see Description)|Efficacy Population||IU/kg/month||Standard Deviation|Mean
685895|NCT01496274|Secondary|Investigator’s Overall Clinical Assessment of Hemostatic Efficacy for Treatment of Bleeding Episodes, Based on a Four Point Ordinal Scales (Excellent, Good, Moderate, Poor/No Response)|Number of bleeding episodes requiring treatment that resulted in hemostatic efficacy of excellent, good, moderate, poor/no response, according to the Investigator’s clinical assessment of hemostatic efficacy, expressed as a percentage of the bleeding episodes requiring treatment.|For the duration of the study; median 20.27 months|Efficacy Population||percentage of bleeding episodes|Participants||Number
685899|NCT01496274|Primary|Number of Subjects Developing Inhibitors Against Factor IX (FIX)|The number of participants developing inhibitors against factor IX (FIX) along with the 95% Clopper-Pearson confidence interval, are summarized for subjects with 50 or more exposure days (EDs) to rIX-FP, and for all participants in the study.|Up to 27.7 months (maximum)|Safety Population||participants||95% Confidence Interval|Number
685900|NCT01496274|Primary|Change in Frequency of Spontaneous Bleeding Events Between On-demand and Prophylaxis Treatments (Annualized)|Subjects in the on-demand arm received on-demand dosing with rIX-FP for up to 26 weeks (on-demand regimen), and then received weekly prophylaxis with rIX-FP for the remainder of the study (prophylaxis regimen). The effectiveness of prophylaxis in comparison to on-demand therapy was investigated by comparing the same subject’s annualized spontaneous bleeding rate (AsBR) during the on-demand regimen and during the prophylaxis regimen.|Up to 26 weeks for on-demand regimen, and between 1 and 17 months for prophylaxis regimen.|This analysis includes only the participants assigned to the on-demand arm who received at least 1 dose of rIX-FP in the on-demand regimen and at least 1 dose of rIX-FP in the prophylaxis regimen.||bleeds/year/subject||Inter-Quartile Range|Median
685901|NCT01496248|Secondary|Clinical Global Index|This was developed for use in psychopharmacology trials and then, it has been expanded in its use as a standard primary measure in studies investigating the efficacy of pharmacological treatments for various psychiatric illnesses such as depression, anxiety disorder, and bipolar disorder. The CGI-S rates the severity of the patient's illness, on a 7-point scale ranging from 1(Normal) 1 to 7(Extremely ill), according to the clinician's experience of patients suffering from the same condition.|8 weeks|||units on a scale||Standard Deviation|Mean
685902|NCT01496248|Secondary|Clinical Global Index|This was developed for use in psychopharmacology trials and then, it has been expanded in its use as a standard primary measure in studies investigating the efficacy of pharmacological treatments for various psychiatric illnesses such as depression, anxiety disorder, and bipolar disorder. The CGI-S rates the severity of the patient's illness, on a 7-point scale ranging from 1(Normal) 1 to 7(Extremely ill), according to the clinician's experience of patients suffering from the same condition.|Baseline|||units on a scale||Standard Deviation|Mean
685903|NCT01496248|Secondary|Montgomery Asberg Depression Rating Scale|This is a 10-item depression rating scale, widely used in depressed patients. Each item is rated from 0 to 6. A total score is the range from 0(none) to 60(most severe). The MADRS has been designed to measure severity of depression in clinical samples and be sensitive to change during antidepressant treatment.|8 weeks|||units on a scale||Standard Deviation|Mean
685904|NCT01496248|Secondary|Montgomery Asberg Depression Rating Scale|This is a 10-item depression rating scale, widely used in depressed patients. Each item is rated from 0 to 6. A total score is the range from 0(none) to 60(most severe). The MADRS has been designed to measure severity of depression in clinical samples and be sensitive to change during antidepressant treatment.|Baseline|||units on a scale||Standard Deviation|Mean
685905|NCT01496248|Secondary|Visual Analogue Scale|This has been described as simple, highly sensitive, and reliable rating scales for subjective experiences. The VAS in this study is used for assessing of variation in severity of residual symptoms. The subject is asked to indicate his/her perceived symptom severity along a 100 mm horizontal line, and this rating is then measure from the left edge (0, no symptom) to right edge (100, most severe).|8 weeks|||units on a scale||Standard Deviation|Mean
685906|NCT01496248|Secondary|Visual Analogue Scale|This has been described as simple, highly sensitive, and reliable rating scales for subjective experiences. The VAS in this study is used for assessing of variation in severity of residual symptoms. The subject is asked to indicate his/her perceived symptom severity along a 100 mm horizontal line, and this rating is then measure from the left edge (0, no symptom) to right edge (100, most severe).|Baseline|||units on a scale||Standard Deviation|Mean
685907|NCT01496248|Primary|Depression Residual Symptom Scale|This consists of 25 items and includes specific residual depressive symptoms, e.g. sadness and anhedonia, lack of energy, psychomotor retardation and anxiety, as well as items reflecting subjective feelings of vulnerability, loss of internal reference points and increased emotionalism. Patients were instructed to compare the past 7 days with the period before the very first symptoms of the most recent depressive episode. Each item is scored as 0 to 3. A total score is the range from 0(none) to 75(most severe).|8 weeks|||units on a scale||Standard Deviation|Mean
685908|NCT01496248|Primary|Depression Residual Symptom Scale|This consists of 25 items and includes specific residual depressive symptoms, e.g. sadness and anhedonia, lack of energy, psychomotor retardation and anxiety, as well as items reflecting subjective feelings of vulnerability, loss of internal reference points and increased emotionalism. Patients were instructed to compare the past 7 days with the period before the very first symptoms of the most recent depressive episode. Each item is scored as 0 to 3. A total score is the range from 0(none) to 75(most severe).|Baseline|||units on a scale||Standard Deviation|Mean
685909|NCT01496183|Secondary|Change From Baseline in Palatability of Meal Using a Visual Analog Scale||Assessed at different time points: 1 week and 2 weeks||||||
685910|NCT01496183|Secondary|Change From Baseline in Appetite Sensations Using a Visual Analog Scale||Assessed at different time points: 1 week and 2 weeks||||||
685911|NCT01496183|Secondary|Physical Activity|motion monitor samples body movements|2 weeks||||||
685912|NCT01496183|Secondary|Change From Baseline in Insulin||Assessed at different time points: 1 week and 2 weeks||||||
685913|NCT01496183|Secondary|Change From Baseline in Leptin||Assessed at different time points: 1 week and 2 weeks||||||
685914|NCT01496183|Secondary|Change From Baseline in Glucose||Assessed at different time points: 1 week and 2 weeks||||||
685915|NCT01496183|Secondary|Change From Baseline in Ghrelin||Assessed at different time points: 1 week and 2 weeks||||||
685916|NCT01496183|Secondary|Change From Baseline in Lipid Profile||Assessed at different time points: 1 week and 2 weeks||||||
685917|NCT01496183|Secondary|Change From Baseline in Resting Metabolic Rate||2 weeks||||||
685918|NCT01496183|Secondary|Change From Baseline in 24-Hour Dietary Recall||Assessed at different time points: 1 week and 2 weeks||||||
685919|NCT01496183|Secondary|Change From Baseline in Body Composition|percent of fat vs. fat-free -or lean mass|2 weeks||||||
685920|NCT01496183|Primary|Change From Baseline in Weight||Assessed at baseline and 2 weeks|||Kg||Standard Deviation|Mean
685928|NCT01495975|Secondary|Unplanned Readmission or ED Visit|Unplanned readmission to any hospital within 30 days of discharge. Emergency department admission to any hospital within 30 days of discharge.|1 month after discharge||||||
685929|NCT01495975|Secondary|Diabetes Self-Management||1 month from discharge||||||
685930|NCT01495975|Secondary|Diabetes Distress|Measured by the Problem Areas in Diabetes (PAID) Questionnaire|1 month from discharge||||||
685931|NCT01495975|Primary|Glycemic Control|Mean patient-day weighted glucose (from glucometer downloads) over the 30 days after discharge|1 month from discharge|||mg/dL||Standard Deviation|Mean
685932|NCT01495923|Secondary|Proceeded to Surgery Within Year of Enrollment|This is a measure of participants that proceeded to surgery within a year of enrollment|Measured within the year of enrollment in the study|Data for this outcome measure was collected one year following the last follow-up. Data was not available for one participant in the epidural steroid injection arm and for three in the gabapentin arm.||Participants|||Count of Participants
685933|NCT01495923|Secondary|Worst Back Pain at 3 Months Measured Using the Numeric Pain Scale|This outcome measure compares the worst back pain at baseline to the worst back pain at 3 months after the start of treatment. This is measured using the Numeric Pain Scale. The Numeric Pain Scale ranges from 0-10. 0 being no pain at all and 10 being the worst imaginable pain possible. The epidural steroid injection group is compared to the gabapentin group.|3 months after the start of treatment|||units on a scale||Standard Deviation|Mean
685934|NCT01495923|Secondary|Worst Back Pain at 1 Month Measured Using the Numeric Pain Scale|This outcome measure compares the worst back pain at baseline to the worst back pain at 1 months after the start of treatment. This is measured using the Numeric Pain Scale. The Numeric Pain Scale ranges from 0-10. 0 being no pain at all and 10 being the worst imaginable pain possible. The epidural steroid injection group is compared to the gabapentin group.|1 month from the start of treatment|||units on a scale||Standard Deviation|Mean
685935|NCT01495923|Secondary|Global Perceived Effect of Treatment at 1 Month After the Start of Treatment|"The participant is asked Are you satisfied with the treatment you have received so far? Participants could respond yes or no. This is measured 1 month after the start of treatment."|1 month after the start of treatment|||Participants|||Count of Participants
685936|NCT01495923|Secondary|Global Perceived Effect of Treatment at 3 Months After the Start of Treatment|"The participant is asked Are you satisfied with the treatment you have received so far? Participants could respond yes or no. This is measured 3 months after the start of treatment."|3 months after the start of treatment|||Participants|||Count of Participants
685937|NCT01495923|Secondary|Outcomes Related to Disability Measured at 3 Month Using the Oswestry Disability Index|Functional capacity measured using Oswestry disability index. The range of possible scores for Oswestry Disability Index are 0-100. 0 is equated with no disability and 100 is the maximum disability possible.|3 months after the start of treatment|||participants||Standard Deviation|Mean
685938|NCT01495923|Secondary|Outcomes Related to Disability Measured at 1 Month Using the Oswestry Disability Index|Functional capacity measured using Oswestry disability index. The range of possible scores for Oswestry Disability Index are 0-100. 0 is equated with no disability and 100 is the maximum disability possible.|1 month after the start of treatment|||units on a scale||Standard Deviation|Mean
685939|NCT01495923|Secondary|Average Back Pain at 3 Months Measured Using the Numeric Pain Scale|This outcome measure compares the average back pain at baseline to the average back pain at 3 months after the start of treatment. This is measured using the Numeric Pain Scale. The Numeric Pain Scale ranges from 0-10. 0 being no pain at all and 10 being the worst imaginable pain possible. The epidural steroid injection group is compared to the gabapentin group.|3 months from the start of treatment|||units on a scale||Standard Deviation|Mean
685961|NCT01495858|Secondary|Karolinska Sleep Diary - Premature Awakening|Subjects responded to the following question : Premature awakening? woke up much too early (1); woke up somewhat too early (2); no (3)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)||Participants|||Number
685940|NCT01495923|Secondary|Average Back Pain at 1 Month Measured Using the Numeric Pain Scale|This outcome measure compares the average back pain at baseline to the average back pain 1 month after the start of treatment. This is measured using the Numeric Pain Scale. The Numeric Pain Scale ranges from 0-10. 0 being no pain at all and 10 being the worst imaginable pain possible. The epidural steroid injection group is compared to the gabapentin group.|1 month fromt he start of treatment|||units on a scale||Standard Deviation|Mean
685941|NCT01495923|Primary|Worst Leg Pain at 3 Months Measured Using the Numeric Pain Scale|This outcome measure compares the worst leg pain at baseline to the worst leg pain at 3 months after the start of treatment. This is measured using the Numeric Pain Scale. The Numeric Pain Scale ranges from 0-10. 0 being no pain at all and 10 being the worst imaginable pain possible. The epidural steroid injection group is compared to the gabapentin group.|3 months from the start of treatment|||units on a scale||Standard Deviation|Mean
685942|NCT01495923|Primary|Worst Leg Pain at 1 Month Measured Using the Numeric Pain Scale|This outcome measure compares the average leg pain at baseline to the average leg pain 1 month after the start of treatment. This is measured using the Numeric Pain Scale. The Numeric Pain Scale ranges from 0-10. 0 being no pain at all and 10 being the worst imaginable pain possible. The epidural steroid injection group is compared to the gabapentin group.|1 month from the start of treatment|||units on a scale||Standard Deviation|Mean
685943|NCT01495923|Primary|Average Leg Pain at 3 Months Measured Using the Numeric Pain Scale|This outcome measure compares the average leg pain at baseline to the average leg pain 3 month after the start of treatment. This is measured using the Numeric Pain Scale. The Numeric Pain Scale ranges from 0-10. 0 being no pain at all and 10 being the worst imaginable pain possible. The epidural steroid injection group is compared to the gabapentin group.|3 months from the start of treatment|||units on a scale||Standard Deviation|Mean
685944|NCT01495923|Primary|Average Leg Pain at 1 Month Measured Using the Numeric Pain Scale|This outcome measure compares the average leg pain at baseline to the average leg pain 1 month after the start of treatment. This is measured using the Numeric Pain Scale. The Numeric Pain Scale ranges from 0-10. 0 being no pain at all and 10 being the worst imaginable pain possible. The epidural steroid injection group is compared to the gabapentin group.|1 month after the start of treatment|||units on a scale||Standard Deviation|Mean
685945|NCT01495858|Other Pre-specified|Vital Signs: Mean Change From Baseline in Respiratory Rate at Day 2||Baseline and day 2|Safety Population||Breaths/min||Standard Deviation|Mean
685946|NCT01495858|Other Pre-specified|Vital Signs: Mean Change From Baseline in Pulse Rate at Day 2||Baseline and day 2|Safety Population||Beats/min||Standard Deviation|Mean
685947|NCT01495858|Other Pre-specified|Vital Signs: Mean Change From Baseline in Diastolic Blood Pressure at Day 2||Baseline and Day 2|Safety Population||mmHg||Standard Deviation|Mean
685948|NCT01495858|Other Pre-specified|Vital Signs: Mean Change From Baseline in Systolic Blood Pressure at Day 2||Baseline and day 2|Safety Population||mmHg||Standard Deviation|Mean
685949|NCT01495858|Secondary|Global Assessment of Investigational Product as a Pain Reliever|The Global Assessment of Investigational Product as a Pain Reliever was a 5- point categorical scale which included the following possible responses: poor (0); fair (1); good (2); very good (3); excellent (4).|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)||Participants|||Number
685950|NCT01495858|Secondary|Cumulative Proportion of Participants Taking Rescue Medication by Hour|If rescue medication was taken by a subject for pain, then the time of rescue medication administration was recorded|Up to 10 hours|Safety Population||participants|||Number
685951|NCT01495858|Secondary|Time to Rescue Medication|If rescue medication was taken by a subject for pain, then the time of rescue medication administration was recorded|Up to 10 hours|ITT (Intent to Treat) Population||Minutes||95% Confidence Interval|Median
685952|NCT01495858|Secondary|Overall Rating of Pain Relief|"The Pain Relief Rating Scale was a 5-point categorical scale which included the following possible responses to the request to finish statement Overall, the relief from my starting pain was: no relief (0); a little relief (1); some relief (2); a lot of relief (3); complete relief (4)."|Up to 10 hours|ITT (Intent to Treat) Population||Participants|||Number
685953|NCT01495858|Secondary|Change From Baseline in Pain Intensity|Pain Severity was collected on a 4-point categorical scale: 0=no pain, 1=mild pain, 2=moderate pain, 4=severe pain|Baseline and up to 10 hours|ITT (Intent to Treat) Population||Scores on a scale||Standard Deviation|Mean
685954|NCT01495858|Secondary|Subjective Sleep Questionnaire - Number of Minutes You Think That You Were Awake From the Time You Fell Asleep Until the Time You Got Out of Bed|Subjects responded to Estimate of the amount of time the subject was awake from the time he or she fell asleep until the time he or she got out of bed (hours and minutes)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)||Minutes||Standard Deviation|Mean
685955|NCT01495858|Secondary|Subjective Sleep Questionnaire - Time to Fall Asleep Last Night|Subjects responded to Estimate of how long it took to fall asleep (minutes)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)||Minutes||Standard Deviation|Mean
685956|NCT01495858|Secondary|Subjective Sleep Questionnaire - Refreshing Nature of Your Sleep Last Night|Subjects responded to Refreshing nature of sleep (10-point scale, where 1 was not refreshing and 10 was very refreshing)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)||Scores on a scale||Standard Deviation|Mean
685957|NCT01495858|Secondary|Subjective Sleep Questionnaire - Quality of Your Sleep Last Night|Subject evaluated sleep quality on a 10-point scale, where 1 was poor and 10 was excellent.|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)||Scores on a scale||Standard Deviation|Mean
685958|NCT01495858|Secondary|Karolinska Sleep Diary - Sufficient Sleep|Subjects responded to the following question: Did you get enough (sufficient) sleep? no, definitely too little (1); no, much too little (2); no, somewhat too little (3); yes, almost enough (4); yes, definitely enough (5)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)||Participants|||Number
685959|NCT01495858|Secondary|Karolinska Sleep Diary - Well Rested|Subjects responded to the following question: Well Rested? not rested at all (1); somewhat unrested (2); completely rested (3)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)||Participants|||Number
685962|NCT01495858|Secondary|Karolinska Sleep Diary - Easiness to Fall Asleep|Subjects responded to the following question: How easy was it to fall asleep? very difficult (1); rather difficult (2); neither difficult nor easy (3); rather easy (4); very easy (5)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)||Participants|||Number
685963|NCT01495858|Secondary|Karolinska Sleep Diary - Calmness of Sleep|Subjects responded to the following question: How calm was your sleep? very restless (1); rather restless (2); neither restless nor calm (3); rather calm (4); very calm (5)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)||Participants|||Number
685964|NCT01495858|Secondary|Karolinska Sleep Diary - Sleep Quality|Subjects responded to the following question: How was your sleep? very poor (1); rather poor (2); neither poor nor good (3); rather good (4); very good (5)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)||Participants|||Number
685965|NCT01495858|Secondary|Global Assessment of Investigational Product as a Sleep Aid|The Global Assessment of Investigational Product as a Sleep-Aid was rated using a 5-point categorical scale for which the potential response was poor (0), fair, (1), good (2), very good (3), or excellent (4).|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)||Participants|||Number
685966|NCT01495858|Secondary|Sleep Efficiency Measured by Actigraphy|Sleep efficiency was calculated as (total sleep time/total time in-bed time) × 100; total in-bed time was fixed at 10 hours. Actigraphy is a non-intrusive tool that measures an individual’s movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.|Up to 10 hours|ITT (Intent to Treat) Population||Percent of sleep time during in-bed time||95% Confidence Interval|Least Squares Mean
685967|NCT01495858|Secondary|Total Sleep Time Measured by Actigraphy|Total time spent sleeping (not to exceed 600 minutes) during the in-bed period as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual’s movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.|Up to 10 hours|ITT (Intent to Treat) Population||Minutes||95% Confidence Interval|Least Squares Mean
685968|NCT01495858|Primary|Sleep Latency Measured by Actigraphy|Sleep latency was defined as the time to sleep onset from the time of dosing as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual’s movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.|Up to 10 hours|ITT (Intent to Treat) Population||Minutes||95% Confidence Interval|Median
685969|NCT01495858|Primary|Wake Time After Sleep Onset (WASO) Measured by Actigraphy|WASO was defined as Total wake time (in minutes) after sleep onset during the 10 hours in-bed period as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual’s movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.|Up to 10 hours|ITT (Intent to Treat) Population||Minutes||95% Confidence Interval|Least Squares Mean
685970|NCT01495793|Primary|Volume of Distribution at Steady State (VSS/f) of Unconjugated Rotigotine 3 mg/24 h (15 cm^2)|"VSS/f was calculated for each subject treated with rotigotine derived from the concentrations of unconjugated rotigotine measured in plasma.
For the primary variables the parametric point estimator for each dose step and the 95% CI was calculated using the least-squares (LS) means and the root mean square of error from the ANOVA of the log-transformed data with subsequent exponential transformation."|0 h (predose), 1 h, 2 h, 7-12 h and 22-24 h on Day 7, 14, 21 and 28|The Pharmacokinetic Per Protocol Set (PKPPS) includes all enrolled subjects who were included in the Safety Set, who had no protocol deviations that were considered to impact the subject's validity for analysis of the primary study objective and who for at least 1 dose step fulfilled specific predefined conditions.||L (Liter)||95% Confidence Interval|Least Squares Mean
685971|NCT01495793|Primary|Volume of Distribution at Steady State (VSS/f) of Unconjugated Rotigotine 2 mg/24 h (10 cm^2)|"VSS/f was calculated for each subject treated with rotigotine derived from the concentrations of unconjugated rotigotine measured in plasma.
For the primary variables the parametric point estimator for each dose step and the 95% CI was calculated using the least-squares (LS) means and the root mean square of error from the ANOVA of the log-transformed data with subsequent exponential transformation."|0 h (predose), 1 h, 2 h, 7-12 h and 22-24 h on Day 7, 14, 21 and 28|The Pharmacokinetic Per Protocol Set (PKPPS) includes all enrolled subjects who were included in the Safety Set, who had no protocol deviations that were considered to impact the subject's validity for analysis of the primary study objective and who for at least 1 dose step fulfilled specific predefined conditions.||L (Liter)||95% Confidence Interval|Least Squares Mean
685972|NCT01495793|Primary|Volume of Distribution at Steady State (VSS/f) of Unconjugated Rotigotine 1 mg/24 h (5 cm^2)|"VSS/f was calculated for each subject treated with rotigotine derived from the concentrations of unconjugated rotigotine measured in plasma.
For the primary variables the parametric point estimator for each dose step and the 95% CI was calculated using the least-squares (LS) means and the root mean square of error from the ANOVA of the log-transformed data with subsequent exponential transformation."|0 h (predose), 1 h, 2 h, 7-12 h and 22-24 h on Day 7, 14, 21 and 28|The Pharmacokinetic Per Protocol Set (PKPPS) includes all enrolled subjects who were included in the Safety Set, who had no protocol deviations that were considered to impact the subject's validity for analysis of the primary study objective and who for at least 1 dose step fulfilled specific predefined conditions.||L (Liter)||95% Confidence Interval|Least Squares Mean
685973|NCT01495793|Primary|Volume of Distribution at Steady State (VSS/f) of Unconjugated Rotigotine 0.5 mg/24 h (2.5 cm^2)|"VSS/f was calculated for each subject treated with rotigotine derived from the concentrations of unconjugated rotigotine measured in plasma.
For the primary variables the parametric point estimator for each dose step and the 95% CI was calculated using the least-squares (LS) means and the root mean square of error from the ANOVA of the log-transformed data with subsequent exponential transformation."|0 h (predose), 1 h, 2 h, 7-12 h and 22-24 h on Day 7, 14, 21 and 28|The Pharmacokinetic Per Protocol Set (PKPPS) includes all enrolled subjects who were included in the Safety Set, who had no protocol deviations that were considered to impact the subject's validity for analysis of the primary study objective and who for at least 1 dose step fulfilled specific predefined conditions.||L (Liter)||95% Confidence Interval|Least Squares Mean
686664|NCT01487577|Primary|Number of Participants With Acute Grade II-IV GVHD, Acute Grade III-IV GVHD, and Chronic GVHD.|Acute GVHD will be graded according to the Modified Glucksberg Staging Criteria. Chronic GVHD will be graded according to NIH Chronic GVHD Consensus Guidelines.|1 year|||participants|||Number
685974|NCT01495793|Primary|Apparent Total Body Clearance (Cl/f) of Unconjugated Rotigotine 3 mg/24 h (15 cm^2)|"CL/f was calculated for each subject treated with rotigotine derived from the concentrations of unconjugated rotigotine measured in plasma.
For the primary variables the parametric point estimator for each dose step and the 95% CI was calculated using the least-squares (LS) means and the root mean square of error from the ANOVA of the log-transformed data with subsequent exponential transformation."|0 h (predose), 1 h, 2 h, 7-12 h and 22-24 h on Day 7, 14, 21 and 28|The Pharmacokinetic Per Protocol Set (PKPPS) includes all enrolled subjects who were included in the Safety Set, who had no protocol deviations that were considered to impact the subject's validity for analysis of the primary study objective and who for at least 1 dose step fulfilled specific predefined conditions.||L/h (Liter per hour)||95% Confidence Interval|Least Squares Mean
685975|NCT01495793|Primary|Apparent Total Body Clearance (Cl/f) of Unconjugated Rotigotine 2 mg/24 h (10 cm^2)|"CL/f was calculated for each subject treated with rotigotine derived from the concentrations of unconjugated rotigotine measured in plasma.
For the primary variables the parametric point estimator for each dose step and the 95% CI was calculated using the least-squares (LS) means and the root mean square of error from the ANOVA of the log-transformed data with subsequent exponential transformation."|0 h (predose), 1 h, 2 h, 7-12 h and 22-24 h on Day 7, 14, 21 and 28|The Pharmacokinetic Per Protocol Set (PKPPS) includes all enrolled subjects who were included in the Safety Set, who had no protocol deviations that were considered to impact the subject's validity for analysis of the primary study objective and who for at least 1 dose step fulfilled specific predefined conditions.||L/h (Liter per hour)||95% Confidence Interval|Least Squares Mean
685976|NCT01495793|Primary|Apparent Total Body Clearance (Cl/f) of Unconjugated Rotigotine 1 mg/24 h (5 cm^2)|"CL/f was calculated for each subject treated with rotigotine derived from the concentrations of unconjugated rotigotine measured in plasma.
For the primary variables the parametric point estimator for each dose step and the 95% CI was calculated using the least-squares (LS) means and the root mean square of error from the ANOVA of the log-transformed data with subsequent exponential transformation."|0 h (predose), 1 h, 2 h, 7-12 h and 22-24 h on Day 7, 14, 21 and 28|The Pharmacokinetic Per Protocol Set (PKPPS) includes all enrolled subjects who were included in the Safety Set, who had no protocol deviations that were considered to impact the subject's validity for analysis of the primary study objective and who for at least 1 dose step fulfilled specific predefined conditions.||L/h (Liter per hour)||95% Confidence Interval|Least Squares Mean
685977|NCT01495793|Primary|Apparent Total Body Clearance (Cl/f) of Unconjugated Rotigotine 0.5 mg/24 h (2.5 cm^2)|"CL/f was calculated for each subject treated with rotigotine derived from the concentrations of unconjugated rotigotine measured in plasma.
For the primary variables the parametric point estimator for each dose step and the 95% CI was calculated using the least-squares (LS) means and the root mean square of error from the ANOVA of the log-transformed data with subsequent exponential transformation."|0 h (predose), 1 h, 2 h, 7-12 h and 22-24 h on Day 7, 14, 21 and 28|The Pharmacokinetic Per Protocol Set (PKPPS) includes all enrolled subjects who were included in the Safety Set, who had no protocol deviations that were considered to impact the subject's validity for analysis of the primary study objective and who for at least 1 dose step fulfilled specific predefined conditions.||L/h (liter per hour)||95% Confidence Interval|Least Squares Mean
685978|NCT01495702|Secondary|Change From Baseline in CD4+ Cell Count at Week 96||Baseline; Week 96|Participants in the Full Analysis Set with available data while on study drug were analyzed; the missing-equals-excluded approach where participants with missing data were excluded from the analysis.||cells/µL||Standard Deviation|Mean
685979|NCT01495702|Secondary|Change From Baseline in CD4+ Cell Count at Week 48||Baseline; Week 48|Participants in the Full Analysis Set with available data were analyzed; the missing-equals-excluded approach where participants with missing data were excluded from the analysis.||cells/µL||Standard Deviation|Mean
685980|NCT01495702|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96|The FDA-defined Snapshot algorithm was used, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time.|Week 96|Full Analysis Set||percentage of participants|||Number
685981|NCT01495702|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48|The FDA-defined Snapshot algorithm was used, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time.|Week 48|Full Analysis Set: participants were randomized, received at least 1 dose of study drug, had no documented resistance, and were on an NNRTI at screening||percentage of participants|||Number
685982|NCT01495689|Secondary|Rate of Recruitment and Retention|Rate of recruitment and retention will be evaluated which will inform feasibility of a larger trial|6 months||||||
685983|NCT01495689|Secondary|Cost-effectiveness Analysis|We will measure direct and indirect costs of the intervention and perform cost-effectiveness analysis of the intervention provided in the out-patient setting with a dedicated nurse available to deliver the intervention.|6 months||||||
685984|NCT01495689|Primary|Biochemically Confirmed (Exhaled CO ≤ 10 Ppm) Self-reported Continuous Abstinence at 26 Weeks.|The primary outcome will be measured at 26 weeks: (1) bio-chemically confirmed 7-day point prevalence abstinence; and (2) self reported continuous abstinence since randomization. Participants who will not be available for follow-up will be considered smokers. At the 26 week follow-up, all patients who report being abstinent from smoking will have their smoking status confirmed by measurement of a CO sample. If any CO will be >10 ppm, the subject will be considered a smoker.|6 months|||Participants|||Count of Participants
685985|NCT01495585|Secondary|ALT Levels||7 months|||U/L||Standard Deviation|Mean
685986|NCT01495585|Primary|Change in Quantitative Serum HDV RNA Levels After 28 Days of Lonafarnib Therapy.||28 days|||log(IU/ml)||Standard Deviation|Mean
685987|NCT01495572|Primary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events, see the adverse event module.|10 months|||participants|||Number
686000|NCT01495000|Secondary|Change From Baseline in Red Blood Cell Count at Month 6|Blood samples were collected for the measurement of red blood cell count values. Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants available at the specified time points were analyzed.||10^12 cells per liter (TI/L)||Standard Deviation|Mean
686665|NCT01487577|Primary|Number of Participants With Grade ≥3 Toxicities Scored According to the CTCAE Version 4.0.||100 days|||participants|||Number
685988|NCT01495572|Primary|Clinical Tumor Response|Complete response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10mm. Partial response (PR) is at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. Progressive disease (PD) is at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum diameters while on study.|One year|||participants|||Number
685989|NCT01495481|Secondary|Number of Participants With Hypotension by Non-invasive Cuff in First 10 Minutes After Medication Administration|Blood pressure changes after dexmedetomidine vs. adenosine. Blood pressure measured by non-invasive cuff prior to medication administration, and then at 1 min, 3 min, 5 min after medication administration. Number of participants with a significant drop in blood pressure (mmHg) compared to baseline would be counted for hypotension.|10 minutes|||participants|||Number
685990|NCT01495481|Secondary|Number of Participants With Tachyarrhythmias After Medication Administration|Number of participants with tachyarrhythmias, including Ventricular (Ventricular Tachycardia & Fibrillation)and supraventricular (Atrial Flutter & Fibrillation) after dexmedetomidine vs. adenosine administration|10 minutes|||participants|||Number
685991|NCT01495481|Secondary|Number of Participants With Sinus Pause >2.5 Sec After Termination of SVT|Evaluation of the number of participants with sinus pause > 2.5 sec, after dexmedetomidine vs. adenosine induced SVT termination|1 minute|||participants|||Number
685992|NCT01495481|Primary|Termination of SVT|Number of participants with SVT Termination within 3 minutes of medication administration|Within 3 minutes|||participants|||Number
685993|NCT01495286|Secondary|Skin Assessment|Areas of skin where the Stim Care electrodes are placed will be assessed for redness, tenderness, or any other change in skin condition. Assessment will take place at baseline, after the NESAP procedure, upon discharge from the hospital, and after one week. If there is a problem at one week, there will be additional follow-up at two weeks.|Post procedure monitoring for the duration of the hospital stay, an expected average of 1 day. Follow up phone calls at one week and again at two weeks if needed.|We based power analysis on 90% power for detecting that the PIPP score had increased by 4, indicating a significant change. With 30 infants,we had 90% power for detecting whether the pain score (PIPP) had increased significantly when testing with a .05 level, one sided paired t test||participants|||Number
685994|NCT01495286|Secondary|Pain During TENS Treatment and Routine Heel Stick|Pain scores were measured using the Premature Infant Pain Profile (PIPP). The PIPP is a composite pain tool that measures pain based on behavioral and physiologic parameters and adjusts for gestational age. Differences in pain scores were recorded throughout the heel stick process, using a baseline score as reference. Mean pain scores were calculated before NESAP (baseline), after the TENS unit was turned on, after ten minutes of NESAP but before heel stick, during heel cleaning, during the initial heel stick, during heel squeeze, and during recovery. For term infants, the range of PIPP scores is on a scale of 0 for no pain to 18 for severe pain. A score of 6 indicate mild pain, and a score of 11 -12 indicates moderate pain. An increase in PIPP score of 4 or greater from baseline indicates a significant change in pain level.|Pain score given during the heel stick process and for 2 minutes afterwards|We based power analysis on 90% power for detecting that the PIPP score had increased by 4, indicating a significant change. With 30 infants, we had 90% power for detecting whether the pain score (PIPP) had increased significantly when testing with a .05 level, one-sided paired t-test.||units on a scale||Standard Deviation|Mean
685995|NCT01495286|Secondary|Blood Pressure During TENS Treatment and Heel Stick|Changes in systolic and diastolic blood pressure after initial baseline. Measurements will be taken at baseline, after 5 minutes of NESAP, at 5 minutes after end of heel stick, and upon return to infant's room.|Duration of the TENS unit treatment and heel stick, an expected average of 20 minutes.|We based power analysis on 90% power for detecting that the PIPP score had increased by 4, indicating a significant change. With 30 infants, we had 90% power for detecting whether the pain score (PIPP) had increased significantly when testing with a .05 level, one-sided paired t-test.||mm Hg||Standard Deviation|Mean
685996|NCT01495286|Primary|Oxygen Saturation During Treatment With TENS Unit and Routine Heel Stick|Changes in oxygen saturation after an initial baseline oxygen saturation. Oxygen saturation will be measured after TENS unit is initiated, for 10 minutes between TENS initiation and heel stick,during heel stick, and for 5 minutes afterwards. Measurements will be taken at baseline, after 5 minutes of NESAP, and at 5 minutes after end of heel stick.|Baseline, duration of the TENS unit treatment and heel stick, an expected average of 20 minutes.|We based power analysis on 90% power for detecting that the PIPP score had increased by 4, indicating a significant increase in pain level. With 30 infants, we had 90% power to detect a significant increase in PIPP score with a .05 level, one-sided paired t-test.||percentage of oxygen saturation||Standard Deviation|Mean
685997|NCT01495286|Primary|Heart Rate During Treatment With TENS Unit|Changes in heart rate will be recorded after an initial baseline heart rate. Heart rate will be taken at baseline, after 5 minutes of NESAP, at 5 minutes after end of heel stick, and upon return to infant's room.|Duration of the TENS unit treatment and heel stick, an expected average of 20 minutes.|We based power analysis on 90% power for detecting that the PIPP score had increased by 4, indicating a significant change. With 30 infants, we had 90% power for detecting whether the pain score (PIPP) had increased significantly when testing with a .05 level, one-sided paired t-test.||beats per minute||Standard Deviation|Mean
685998|NCT01495000|Secondary|Number of Participants With Positive and Negative Results for Anti-body Formation to Denosumab at Month 6|The number of participants with positive and negative results for both neutralizing antibodies to denosumab and for binding antibodies to denosumab at Month 6 are summarized.|Month 6|ITT Population. Only participants available at the specified time point were analyzed.||participants|||Number
685999|NCT01495000|Secondary|Change From Baseline in Red Cell Distribution Width at Month 6|Blood samples were collected for the measurement of red cell distribution width values. Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants available at the specified time points were analyzed.||percentage||Standard Deviation|Mean
686666|NCT01487525|Secondary|Knee Pain|Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire Pain Sub-Scale (0-100); larger absolute values represent less pain; a positive % changes indicates a reduction in pain|0, 6 weeks|||Percent change||Standard Deviation|Mean
686001|NCT01495000|Secondary|Change From Baseline in Mean Corpuscular Volume at Month 6|Blood samples were collected for the measurement of mean corpuscular volume values. Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants available at the specified time points were analyzed.||femtoliters||Standard Deviation|Mean
686002|NCT01495000|Secondary|Change From Baseline in Mean Corpuscle Hemoglobin at Month 6|Blood samples were collected for the measurement of hemoglobin values. Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants available at the specified time points were analyzed.||picograms||Standard Deviation|Mean
686003|NCT01495000|Secondary|Change From Baseline in Hematocrit at Month 6|Blood samples were collected for the measurement of hematocrit values. Change from Baseline was calculated as the Month 6 value minuse the Baseline value.|Baseline and Month 6|ITT Population. Only participants available at the specified time points were analyzed.||proportion of RBCs in blood||Standard Deviation|Mean
686004|NCT01495000|Secondary|Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, and Very Low-density Lipoproteins (VLDL) Cholesterol Calculation at Month 6|Blood samples were collected for the measurement of calcium corrected, calcium, chloride, glucose, potassium, magnesium, sodium, phosphorus inorganic, triglyceride, urea/BUN, and VLDL cholesterol calculation values. Change from Baseline was calcualted as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects the entire ITT Population.||millimoles per liter (MMOL/L)||Standard Deviation|Mean
686005|NCT01495000|Secondary|Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid at Month 6|Blood samples were collected for the measurement of direct bilirubin, indirect bilirubin, total bilirubin, creatinine, and uric acid values. Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects the entire ITT Population.||micromoles per liter (UMOL/L)||Standard Deviation|Mean
686006|NCT01495000|Secondary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Total Neutrophils, Platelet Count, and White Blood Cell Count Month 6|Blood samples were collected for the measurement of basophil, eosinophil, lymphocyte, monocyte, segmented neutrophil, total neutrophil, platelet count, and white blood cell count values. Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects the entire ITT Population.||10^9 cells per liter (GI/L)||Standard Deviation|Mean
686007|NCT01495000|Secondary|Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase, and Lactate Dehydrogenase at Month 6|Blood samples were collected for the measurement of alkaline phosphatase, alanine amino transferase, aspartate amino transferase, creatinine kinase, gamma glutamyl transferase, and lactate dehydrogenase values. Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects the entire ITT Population.||International units per liter (IU/L)||Standard Deviation|Mean
686008|NCT01495000|Secondary|Change From Baseline in Albumin, Hemoglobin, Mean Corpuscle Hemoglobin Concentration (Conc.), and Total Protein at Month 6|Blood samples were collected for the measurement of albumin, hemoglobin, mean corpuscle hemoglobin concentration, and total protein values. Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects the entire ITT Population.||grams per liter (g/L)||Standard Deviation|Mean
686009|NCT01495000|Secondary|Change From Baseline in Albumin/Globulin Ratio and Blood Urea Nitrogen (BUN)/Creatinine Ratio at Month 6|Blood samples were collected for the measurement of albumin/globulin ratio and BUN/creatinine ratio values. Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants available at the specified time points were analyzed.||ratio||Standard Deviation|Mean
686010|NCT01495000|Secondary|Number of Participants With the Indicated Laboratory Parameter Values of Potential Clinical Concern at Month 6|The number of participants with laboratory parameter values of potential clinical concern at Month 6 are summarized. The following are the laboratory values of potential clinical concern: alkaline phosphatase, High: >375 units/Liter (L); aspartate aminotransferase, High: >165 units/L; creatinine, High: >159 micromoles (µmol)/L; glucose, Low: <3 millimoles (mmol)/L; hematocrit, Low: <0.325; hemoglobin, Low: <91grams/L; phosphorus, High: >1.723 mmol/L; potassium, High: >6.3 mmol/L; sodium, Low: <130 mmol/L; total neutrophils, Low: <0.9 10^9 cells (GI)/L; blood urea nitrogen (BUN), High: >21mmol/L; uric acid, High: 654 µmol/L.|Month 6|ITT Population. Only participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points/for different parameters, so the overall number of participants analyzed reflects the entire ITT Population.||participants|||Number
686022|NCT01494818|Secondary|Protective Index|A digital video recording was made of the interblink period. The percentage of area of the visible contact lens covered by the tear film was calculated (Protected Area). The Protective Index is defined as the average tear coverage over the whole interblink period. Both eyes were included in the model for analysis.|Baseline, Month 3|All enrolled and dispensed participants who completed the study as per protocol||Percent of visible contact lens surface||Standard Deviation|Mean
686667|NCT01487525|Secondary|Isokinetic Knee Extensor Strength||0, 6 weeks|||percent change||Standard Error|Mean
686668|NCT01487525|Primary|Change in Isotonic Leg Press 1RM|double leg press 1 rep maximum strength|0,6 weeks|||percent change||Standard Deviation|Mean
686011|NCT01495000|Secondary|Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Months 1, 3, and 6|"Vital sign values of potential clinical concern were defined as: change in heart rate >30 beats per minutes (bpm), change in systolic blood pressure (SBP) >30 millimeters of mercury (mmHg), and change in diastolic blood pressure (DBP) >20 mmHg. The number of participants with post-Baseline vital sign values of potential clinical concern who did not have values of potential clinical concern at Baseline are summarized. If the change from Baseline is a decrease greater than the threshold, it is categorized as “low.” If the change from Baseline is an increase greater than the threshold, it is categorized ad “high."|Baseline; Months 1, 3, and 6|ITT Population. Only participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points/for different parameters, so the overall number of participants analyzed reflects the entire ITT Population.||participants|||Number
686012|NCT01495000|Secondary|Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury with hyperbilirubinaemia. Medical or scientific judgment was to have been exercised in other important medical events. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.|From Baseline up to Month 6|ITT Population: all participants who received one dose of study medication||participants|||Number
686013|NCT01495000|Secondary|Median Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (s-CTX) and Serum Procollagen Type IN Propeptide (s-PINP) Markers at Months 1, 3, and 6|Blood samples were collected for the measurement of s-CTx and s-PINP, which are used as biomarkers of bone resorption and formation, respectively. The median percent change from Baseline in s-CTX and s-PINP markers at Months 1, 3, and 6 was calculated as: (post-Baseline value minus Baseline value) * 100 / Baseline value.|Baseline; Months 1, 3, and 6|ITTE Population. Only participants with s-CTX and s-PINP values at both Baseline and Months 1, 3, and 6 were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points/for different parameters, so the overall number of participants analyzed reflects the entire ITTE Population.||percent change||Inter-Quartile Range|Median
686014|NCT01495000|Secondary|Mean Percent Change From Baseline in BMD at the Total Hip, Femoral Neck, and Trochanter at Month 6|BMD at the total hip, femoral neck, and trochanter was measured by the DXA scanner. The mean percent change from Baseline in BMD was calculated as: (value at Month 6 minus Baseline value) * 100 / Baseline value. Analysis was performed using an ANCOVA model with terms for treatment and corresponding Baseline BMD (as a continuous covariate).|Baseline and Month 6|ITTE Population. Only participants with BMD values at both Baseline and Month 6 were analyzed.||percent change||Standard Error|Least Squares Mean
686015|NCT01495000|Primary|Mean Percent Change From Baseline in Bone Mineral Density at the Lumbar Spine at Month 6|Bone mineral density (BMD) at the lumbar spine was measured by the dual-energy x-ray absorptiometry (DXA) scanner. The mean percent change from Baseline in BMD was calculated as: (value at Month 6 minus Baseline value) * 100 / Baseline value. Analysis was performed using an Analysis of Covariance (ANCOVA) model with terms for treatment and baseline BMD at the lumbar spine (as a continuous covariate).|Baseline and Month 6|Intent-to-Treat Efficacy (ITTE) Population: all randomized participants who received one dose of study medication, and who had a Baseline measure and at least one post-Baseline efficacy measure during the Double-blind Treatment Phase. Only participants with BMD values at both Baseline and Month 6 were analyzed.||percent change||Standard Error|Least Squares Mean
686016|NCT01494987|Secondary|Change From Baseline in 2-hour Postprandial Serum Glucose at Week 24|The average (mean) change from baseline in 2-hour postprandial serum glucose at Week 24 was analyzed.|Baseline; Week 24|Participants in the MMTT Full Analysis Set with available data were analyzed.||mg/dL||Standard Deviation|Mean
686017|NCT01494987|Secondary|Change From Baseline in Fasting Serum Glucose at Week 24|The average (mean) change from baseline in fasting serum glucose at Week 24 was analyzed.|Baseline; Week 24|Participants in the Full Analysis Set with available data were analyzed.||mg/dL||Standard Deviation|Mean
686018|NCT01494987|Secondary|Change From Baseline in Incremental Change of 2-hour Postprandial Serum Glucose at Week 24|"The average (mean) change from baseline in incremental change of 2-hour postprandial serum glucose at Week 24 was analyzed.
Mixed Meal Tolerance Test (MMTT) Full Analysis Set: randomized participants who received at least one dose of study treatment with a baseline and at least one postbaseline measurement of serum glucose at T=120 minutes during the MMTT, administered under fasting conditions, excluding participants with major eligibility protocol violations, analyzed based on the randomized treatment regardless of actual treatment received."|Baseline; Week 24|Participants in the Mixed Meal Tolerance Test (MMTT) Full Analysis Set with available data were analyzed.||mg/dL||Standard Deviation|Mean
686019|NCT01494987|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|The average (mean) change from baseline in HbA1c at Week 24 was analyzed.|Baseline; Week 24|Participants in the Full Analysis Set (randomized participants who received ≥ 1 dose of study treatment with a baseline and at least one postbaseline measurement of HbA1c, excluding participants with major eligibility violations and analyzed based on randomized treatment, regardless of actual treatment received) with available data were analyzed.||percent of HbA1c in blood||Standard Deviation|Mean
686020|NCT01494818|Secondary|Total Lipid Uptake Per Lens|The contact lens was aseptically removed from the eye. Lipids were extracted and analyzed using a proprietary High Performance Liquid Chromatography technique. A lower value would indicate a cleaner lens surface.|Baseline, Month 3|All enrolled and dispensed participants who completed the study as per protocol||micrograms||Standard Deviation|Mean
686021|NCT01494818|Secondary|Median Front Lens Deposits|Deposits present on the front surface of the lens were assessed with a biomicroscope while the lens was on eye. Deposits were rated on a 5-point forced choice scale (0 = none; 1 = slight; = mild; 3 = moderate; 4 = severe) in five lens zones. The median of the five zones was used for analysis. Both eyes were included in the model for analysis.|Baseline, Month 3|All enrolled and dispensed participants who completed the study as per protocol||Units on a scale||Full Range|Median
686669|NCT01487499|Secondary|Overall Survival|Subjects will be followed for 5 years or the remainder of the subject's life in order to determine long-term 5 year survival rates.|5 years||||||
686023|NCT01494818|Primary|Change From Baseline in Upper Eyelid Margin Staining at Month 3|The contact lens was removed and ophthalmic dye was instilled. Upper eyelid margin staining was objectively measured through digital images. The extent of true staining (i.e., the total area of lid margin covered by staining) was recorded. Both eyes were included in the model for analysis.|Baseline, Month 3|All enrolled and dispensed participants who completed the study as per protocol||square millimeters||Standard Deviation|Mean
686024|NCT01494818|Primary|Upper Lid Redness|The contact lenses were removed and upper lid redness was objectively measured through digital images. The coverage of the palpebral surface by blood vessels is expressed as percentage of the total surface measured. Both eyes were included in the model for analysis.|Baseline, Month 3|All enrolled and dispensed participants who completed the study as per protocol||Percentage of total surface measured||Standard Deviation|Mean
686025|NCT01494818|Secondary|Median Non-Invasive Pre-Lens Tear Film Break Up Time (PL-NIBUT)|The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eyelid and the contact lens). The time required for a dry spot to appear on the pre-lens surface after blinking is referred to as the pre-lens tear film break up time. PL-NIBUT was evaluated using a biomicroscope with a diffuse illumination source, i.e., Tearscope. A longer PL-NIBUT indicates a more stable tear film and greater on-eye lens wettability. Three PL-NIBUT measurements were recorded, and the median value was used for analysis. Both eyes were included in the model for analysis.|Baseline, Month 3|All enrolled and dispensed participants who completed the study as per protocol||Seconds||Standard Deviation|Mean
686026|NCT01494818|Primary|Maximum Eyelid Hyperaemia|Eyelid hyperaemia (redness) was recorded separately for three zones of the upper lid and overall for the lower lid on a 5-point forced choice scale (0 = Clear; 1 = Slight redness; 2 = Mild redness; 3 = Moderate redness; 4 = Severe redness). The maximum value represents the worst grade in any zone. Both eyes were included in the model for analysis.|Baseline, Month 3|All enrolled and dispensed participants who completed the study as per protocol||Units on a scale||Full Range|Median
686027|NCT01494818|Primary|Maximum Papillae|Eyelid papillae (bumps on the inner eyelid) were recorded separately for three zones of the upper lid and overall for the lower lid on a 5-point forced choice scale (0 = None; 1 = Slight (diffuse papillae); 2 = Mild (diffuse & tufts papillae); 3 = Moderate (moderate & tufts papillae); 4 = Severe (giant papillae). The maximum value represents the worse grade in any zone. Both eyes were included in the model for analysis.|Baseline, Month 3|All enrolled and dispensed participants who completed the study as per protocol||Units on a scale||Full Range|Median
686028|NCT01494753|Primary|Mean Intra Ocular Pressure (IOP) at 8.00am|Efficacy criteria at 8.00am on Day 42 and on Day84. Worse Eye= the eligible eye (with at least one out of the 4 individual IOP values on Day 0 >= 22 and <=30mmHg) with the highest individual IOP at 8.00am on Day 0. If both eyes are eligible and have the same individual IOP at 8.00am on Day 0, the right eye is considered.|Day 42 and Day 84 (8.00am for the IOP)|Per protocol (PP) set: All patients enrolled in the study for whom any follow-up efficacy information was evaluable and who did not show any major protocol deviation that could affect the efficacy assessment.||mmHg||Standard Deviation|Mean
686029|NCT01494649|Secondary|Adjusted Mean Change From Baseline in Tooth Hypersensitity to Touch Stimuli (Tactile) Immediately at Day 14|Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 80 grams of force applied to hypersensitive tooth until pain was elicited. Grams of force needed to elicit pain was recorded as hypersensitivity score for the tooth. The higher the score, the lower the hypersensitivity. Hypersensitivity scores on a per study participant basis was recorded as mean scores of all hypersensitive teeth. Change was calculated as mean score at Day 14 minus mean score at baseline.|Baseline and Day 14|ITT population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. No data was imputed in the case of dropouts or missing data.||units on a scale||95% Confidence Interval|Mean
686030|NCT01494649|Secondary|Adjusted Mean Change From Baseline in Tooth Hypersensitity to Touch Stimuli (Tactile) Immediately at Day 3|Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 80 grams of force applied to hypersensitive tooth until pain was elicited. Grams of force needed to elicit pain was recorded as hypersensitivity score for the tooth. The higher the score, the lower the hypersensitivity. Hypersensitivity scores on a per study participant basis was recorded as mean scores of all hypersensitive teeth. Change was calculated as mean score at Day 3 minus mean score at baseline.|Baseline and Day 3|ITT population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. No data was imputed in the case of dropouts or missing data.||units on a scale||95% Confidence Interval|Mean
686031|NCT01494649|Secondary|Adjusted Mean Change From Baseline in Tooth Hypersensitity to Touch Stimuli (Tactile) Immediately After Treatment|Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 80 grams of force applied to hypersensitive tooth until pain was elicited. Grams of force needed to elicit pain was recorded as hypersensitivity score for the tooth. The higher the score, the lower the hypersensitivity. Hypersensitivity scores on a per study participant basis was recorded as mean scores of all hypersensitive teeth. Change was calculated as mean score immediately after treatment minus mean score at baseline.|Baseline and immediately after treatment administration|ITT population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. No data was imputed in the case of dropouts or missing data.||units on a scale||95% Confidence Interval|Mean
686032|NCT01494649|Secondary|Adjusted Mean Change From Baseline in Tooth Hypersensitivity to Air Stimuli at Day 14|Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth evaluated using Schiff Cold Air Sensitivity Scale. According to this analog scale hypersensitivity scores for the stimulated tooth is 0, 1, 2 or 3 (lower the score, lower the hypersensitivity). 0=No participant response to stimulus, 1=responds but will continue, 2=responds and moves or requests discontinuation, 3=Painful response to stimulus, discontinuation requested. Change was Schiff score on Day 14 minus Schiff score at baseline.|Baseline and Day 14|ITT population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. No data was imputed in the case of dropouts or missing data.||units on a scale||95% Confidence Interval|Mean
686670|NCT01487499|Secondary|Progression-free Survival||18 months||||||
686033|NCT01494649|Secondary|Adjusted Mean Change From Baseline in Tooth Hypersensitivity to Air Stimuli at Day 3|Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth evaluated using Schiff Cold Air Sensitivity Scale. According to this analog scale hypersensitivity scores for the stimulated tooth is 0, 1, 2 or 3 (lower the score, lower the hypersensitivity). 0=No participant response to stimulus, 1=responds but will continue, 2=responds and moves or requests discontinuation, 3=Painful response to stimulus, discontinuation requested. Change was Schiff score on Day 3 minus Schiff score at baseline.|Baseline and Day 3|ITT population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. No data was imputed in the case of dropouts or missing data.||units on a scale||95% Confidence Interval|Mean
686034|NCT01494649|Primary|Adjusted Mean Change From Baseline in Tooth Hypersensivity to Air Stimuli Immediately Following Treatment|Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth was evaluated using Schiff Cold Air Sensitivity Scale. According to this analog scale hypersensitivity scores for the stimulated tooth is 0, 1, 2 or 3 (lower the score, lower the hypersensitivity).0= no response; 1= response and no discontinuation request; 2= response and discontinuation request; 3= painful response and discontinuation request. Change was calculated as Schiff score immediately after treatment minus Schiff score at baseline.|Baseline and immediately after treatment administration|Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. No data was imputed in the case of dropouts or missing data.||units on a scale||95% Confidence Interval|Mean
686035|NCT01494610|Secondary|Number of Participants With an Adverse Event (AE)|An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Randomization (Day 1) up to Follow-up (Days 47-50)|All Subjects Population. Out of the total population, 34 participants had asthma and 26 participants had COPD. Only those participants contributing data at the indicated time points were analyzed.||participants|||Number
686036|NCT01494610|Secondary|Mean Calcium, Chloride, Glucose, Potassium, Sodium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicar), and Urea/Blood Urea Nitrogen (BUN)|"Blood samples of participants were collected for the evaluation of calcium, chloride, glucose, potassium, sodium, carbon dioxide (CO2) content/bicarbonate, and urea/BUN. All of these parameters are measured to help assess the condition of the kidneys. The timing of the first and second administrations depended on the randomization schedule. If the treatment sequence received was ABBA, then Days 10 and 40, respectively, correspond to the first and second administrations for treatment A."|Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|All Subjects Population. Out of the total population, 34 participants had asthma and 26 participants had COPD. Only those participants contributing data at the indicated time points were analyzed.||µmol/L||Standard Deviation|Mean
686037|NCT01494610|Secondary|Mean Direct Bilirubin (DB), Total Bilirubin (TB), Creatinine, and Uric Acid|"Blood samples of participants were collected for the evaluation of DP, TB, creatinine, and uric acid. DB and TB are measures that help assess the condition of the liver, and creatinine and uric acid are measures that help assess the condition of the kidneys. The timing of the first and second administrations depended on the randomization schedule. If the treatment sequence received was ABBA, then Days 10 and 40, respectively, correspond to the first and second administrations for treatment A."|Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|All Subjects Population. Out of the total population, 34 participants had asthma and 26 participants had COPD. Only those participants contributing data at the indicated time points were analyzed.||Micromoles per liter (µmol/L)||Standard Deviation|Mean
686038|NCT01494610|Secondary|Mean Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amio Transferase (AST), and Gama Glutamyl Transferase (GGT)|"Blood samples of participants were collected for the evaluation of AP, ALT, AST, and GGT. All of these parameters are measured to help assess the condition of the liver. The timing of the first and second administrations depended on the randomization schedule. If the treatment sequence received was ABBA, then Days 10 and 40, respectively, correspond to the first and second administrations for treatment A."|Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|All Subjects Population. Out of the total population, 34 participants had asthma and 26 participants had COPD. Only those participants contributing data at the indicated time points were analyzed.||International units per liter (IU/L)||Standard Deviation|Mean
686039|NCT01494610|Secondary|Mean Albumin and Total Protein|"The timing of the first and second administrations depended on the randomization schedule. If the treatment sequence received was ABBA, then Days 10 and 40, respectively, correspond to the first and second administrations for treatment A."|Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|All subjects Population. Out of the total population, 34 participants had asthma and 26 participants had COPD. Only those participants contributing data at the indicated time points were analyzed.||g/L||Standard Deviation|Mean
686040|NCT01494610|Secondary|Mean Hematocrit|"Blood samples of participants were collected for the evaluation of hematocrit. The hematocrit is the percentage of the RBCs in the blood. The timing of the first and second administrations depended on the randomization schedule. If the treatment sequence received was ABBA, then Days 10 and 40, respectively, correspond to the first and second administrations for treatment A."|Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|All Subjects Population. Out of the total population, 34 participants had asthma and 26 participants had COPD. Only those participants contributing data at the indicated time points were analyzed.||percentage of RBCs||Standard Deviation|Mean
686060|NCT01494610|Secondary|Mean AUC(0-tlast) for FP|Blood samples of participants with asthma and COPD were collected and analyzed for AUC(0-tlast). AUC(0-tlast) is a measure of the plasma drug concentration from pre-dose to the last measurable concentration.|At pre-morning dose; 5, 10, 30 minutes post-dose (PD); and 1, 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|PK/PD Population||pg*h/mL||95% Confidence Interval|Geometric Mean
686041|NCT01494610|Secondary|Mean Corpuscle Volume (MCV)|"Blood samples of participants were collected for the evaluation of MCV. MCV is a measure of the average red blood cell size that is reported as part of a standard complete blood count. The timing of the first and second administrations depended on the randomization schedule. If the treatment sequence received was ABBA, then Days 10 and 40, respectively, correspond to the first and second administrations for treatment A."|Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|All Subjects Population. Out of the total population, 34 participants had asthma and 26 participants had COPD. Only those participants contributing data at the indicated time points were analyzed.||Femtoliters (fL; 10^-15 L)/cell||Standard Deviation|Mean
686042|NCT01494610|Secondary|Mean Corpuscule Hemoglobin (MCH)|"Blood samples of participants were collected for the evaluation of MCH. MCH is the average mass or amount of hemoglobin per red blood cell in a sample of blood. The timing of the first and second administrations depended on the randomization schedule. If the treatment sequence received was ABBA, then Days 10 and 40, respectively, correspond to the first and second administrations for treatment A."|Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|All Subject Population. Out of the total population, 34 participants had asthma and 26 participants had COPD. Only those participants contributing data at the indicated time points were analyzed.||picograms (pg)/cell||Standard Deviation|Mean
686043|NCT01494610|Secondary|Red Blood Cell (RBC) Count and Reticulocytes|"Blood samples of participants were collected for the evaluation of RBC and reticulocytes count. Reticulocytes are immature red blood cells. Normally, about 1% to 2% of the red blood cells in the blood are reticulocytes. The timing of the first and second administrations depended on the randomization schedule. If the treatment sequence received was ABBA, then Days 10 and 40, respectively, correspond to the first and second administrations for treatment A."|Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|All Subjects Population. Out of the total population, 34 participants had asthma and 26 participants had COPD. Only those participants contributing data at the indicated time points were analyzed.||Trillion (10^12) cells/L||Standard Deviation|Mean
686044|NCT01494610|Secondary|Mean Hemoglobin and Mean Corpuscular Hemoglobin (MCH) Concentration|"Blood samples of participants were collected for the evaluation of mean hemoglobin (mean level of hemoglobin in the whole blood sample) and MCH concentration. The MCH concentration is the average concentration of hemoglobin in a red blood cell. Hemoglobin is the red pigment in the blood, and it is reponsible for carrying oxygen. The timing of the first and second administrations depended on the randomization schedule. If the treatment sequence received was ABBA, then Days 10 and 40, respectively, correspond to the first and second administrations for treatment A."|Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|All Subjects Population. Out of the total population, 34 participants had asthma and 26 participants had COPD. Only those participants contributing data at the indicated time points were analyzed.||Grams per liter (g/L)||Standard Deviation|Mean
686045|NCT01494610|Secondary|Mean Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell (WBC) Count|"Blood samples of participants were collected for the evaluation of basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count, and WBC count. Data are reported for the first (1st) and second (2nd) administration (admin) of FP/salmeterol via MDPI or capsule-based inhaler. The timing of the first and second administrations depended on the randomization schedule. If the treatment sequence received was ABBA, then Days 10 and 40, respectively, correspond to the first and second administrations for treatment A."|Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|All Subjects Population: all participants who received at least one dose of study medication. Out of the total population, 34 participants had asthma and 26 participants had COPD. Only those participants contributing data at the indicated time points were analyzed.||Giga (10^9) cells/L||Standard Deviation|Mean
686046|NCT01494610|Secondary|Weighted Mean Over 0 to 4 Hours Post Dose and Maximum Plasma Glucose|Blood samples of participants were collected for the evaluation of weighted mean over 0 to 4 hours post dose and the maximum plasma glucose level. Weighted mean was calculated by using all values of plasma glucose at the indicated timepoint contributing to the calculation of the mean but with different weightage.|At pre-morning dose; 30, 60 minutes post-dose (PD); and 2 and 4 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|PK/PD Population||mmol/L||Standard Deviation|Mean
686047|NCT01494610|Secondary|Weighted Mean Over 0 to 4 Hours Post Dose of Plasma Potassium and Minimum (Min) Plasma Potassium|Blood samples of participants were collected for the evaluation of weighted mean over 0 to 4 hours post dose and the minimum plasma potassium level. Weighted mean was calculated by using all values of plasma potassium at the indicated timepoint contributing to the calculation of the mean but with different weightage.|At pre-morning dose; 30, 60 minutes post-dose (PD); and 2 and 4 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|Only those participants contributing data at the indicated time points were analyzed.||Millimoles per liter (mmol/L)||Standard Deviation|Mean
686048|NCT01494610|Secondary|Maximum and Weighted Mean Over 0 to 4 Hours Post Dose of the QT Interval Corrected According to Bazett’s Formula (QTc[B]) and the QT Interval Corrected According to Fridericia’s Formula (QTc[F])|The electrocardiogram (ECG) of the participants was taken, and the maximum and weighted mean of QTc(B) and QTc(F) was measured. Weighted mean was calculated by using all values of QTc(B) and QTc(F) at the indicated timepoint contributing to the calculation of the mean but with different weightage. The ECG helps in the assessment of the condition of the heart. The QT interval gives the measure of the heart rate, and the cQT interval gives the corrected value.|At pre-morning dose; 15, 30, 60, 90 minutes post-dose (PD); and 2, 3 and 4 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|PK/PD Population||Milliseconds (msec)||Standard Deviation|Mean
687364|NCT01477749|Primary|Cumulative Total Nucleated Cell (TNC) Count|Descriptive summarization of the cumulative sum of TNC counts across infusions|Before and after culture with PAP-GM-CSF, on Day 3 (first infusion) and on approximately Days 17 and 31 (second and third infusion, respectively)|||10^9 cells/mL||Standard Error|Mean
686049|NCT01494610|Secondary|Minimum Diastolic Blood Pressure (DBP), Maximum Systolic Blood Pressure (SBP), and Weighted Mean for DBP and SBP Over 0 to 4 Hours Post Dose|The diastolic and systolic blood pressure of the participants was measured. The maximum and minimum observed values from the time of the morning dose on Day 10 to 4 hours post dose were measured for SBP and DBP. The weighted mean value from the time of the morning dose on Day 10 to 4 hours post dose was calculated. Weighted mean was calculated by using all values of DBP and SBP at the indicated timepoint contributing to the calculation of the mean but with different weightage.|At pre-morning dose; 15, 30, 60, 90 minutes post-dose (PD); and 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|PK/PD Population||millimeters of mercury (mmHg)||Standard Deviation|Mean
686050|NCT01494610|Secondary|Mean of Maximum Heart Rate Over 0 to 4 Hours Post Dose for Salmeterol|The maximum observed value of heart rate was measured from the time of the morning dose on Day 10 to 4 hours post dose.|At pre-morning dose; 15, 30, 60, 90 minutes post-dose (PD); and 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|PK/PD Population||bpm||Standard Deviation|Mean
686051|NCT01494610|Secondary|Weighted Mean Over 0 to 4 Hours Post Dose of Heart Rate for Salmeterol|The heart rate (number of heartbeats per unit of time, typically expressed as beats per minute [bpm]) of the participants was monitored for evaluating the weighted mean over the course of 0 to 4 hours post dose. The Capsule-MDPI difference for heart rate was calculated for each participant, and the weighted mean value from the time of the morning dose on Day 10 to 4 hours post dose was calculated. The weighted mean was calculated by using all values at the indicated timepoint contributing to the calculation of the mean but with different weightage.|At pre-morning dose; 15, 30, 60, 90 minutes post-dose (PD); and 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|PK/PD Population||bpm||Standard Deviation|Mean
686052|NCT01494610|Secondary|Serum Cortisol Minimum (Cmin) for FP|Blood samples of participants were collected for the evaluation of minimum serum cortisol. Any differences in systemic exposure as a result of the absorbed steroid component of the two differing inhaled devices should also result in differences in serum cortisol concentrations.|Day 10 of each study period (Periods 1-4); Study Day 10 (+/-1) (reference day is Study Day 1 or Randomization day), Period 1; Study Day 20 (+/-1), Period 2; Study Day 30 (+/-1), Period 3; Study Day 40 (+/-1), Period 4|PK/PD Population||nmol/L||95% Confidence Interval|Geometric Mean
686053|NCT01494610|Secondary|Mean Urine Cortisol Excretion Over 0 to 24 Hours Post Dose for FP|Urine samples of participants were collected to evaluate urine cortisol excretion over 0-24 hours post treatment dose. A 24-hour urine cortisol sample was used to measure the total amount of cortisol excreted in urine in 24 hours. Any differences in systemic exposure as a result of the absorbed steroid component of the two differing inhaled devices should also result in differences in the amount of cortisol excreted in the urine.|0-24 hours post dose on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|PK/PD Population||nmol||95% Confidence Interval|Geometric Mean
686054|NCT01494610|Secondary|Tmax for Salmeterol|Blood samples of participants were collected for evaluating Tmax. Tmax is a measure of the time required to reach the maximum concentration of the drug.|At pre-morning dose; 5, 10, 30 minutes post-dose (PD); and 1, 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|PK/PD Population||hours||Full Range|Median
686055|NCT01494610|Secondary|Mean Terminal Phase Half-life (t1/2) for Salmeterol|Blood samples of participants were collected for evaluating t1/2. t1/2 is the time required for the plasma/blood concentration of the drug to decrease by 50% after the false equilibrium of distribution has been reached.|At pre-morning dose; 5, 10, 30 minutes post-dose (PD); and 1, 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|PK/PD Population. Only those participants contributing data at the indicated time points were analyzed.||hours||95% Confidence Interval|Geometric Mean
686056|NCT01494610|Secondary|Mean Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) for Salmeterol|Blood samples of participants with asthma and COPD were collected and analyzed for Cmax and Cmin of Salmeterol in the blood. Cmax and Cmin are used to estimate the time at which the activity of the drug will be at its maximum and minimum.|At pre-morning dose; 5, 10, 30 minutes post-dose (PD); and 1, 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|PK/PD Population||pg/mL||95% Confidence Interval|Geometric Mean
686057|NCT01494610|Secondary|Time of Occurrence of Cmax (Tmax) for FP|Blood samples of participants were collected for evaluating Tmax. Tmax is a measure of the time required to reach the maximum concentration of the drug.|At pre-morning dose; 5, 10, 30 minutes post-dose (PD); and 1, 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|PK/PD Population||hours||Full Range|Median
686058|NCT01494610|Secondary|Mean Terminal Phase Half-life (t1/2) for FP|Blood samples of participants were collected for evaluating t1/2. The t1/2 is the time required for the plasma/blood concentration of the drug to decrease by 50% after the false equilibrium of distribution has been reached.|At pre-morning dose; 5, 10, 30 minutes post-dose (PD); and 1, 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|PK/PD Population. Only those participants contributing data at the indicated time points were analyzed.||hours||95% Confidence Interval|Geometric Mean
686059|NCT01494610|Secondary|Mean Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) of FP|Blood samples of participants with asthma and COPD were collected and analyzed for Cmax and Cmin of FP in the blood. Cmax and Cmin are used to estimate the time at which the activity of the drug will be at its maximum and minimum, respectively.|At pre-morning dose; 5, 10, 30 minutes post-dose (PD); and 1, 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|PK/PD Population||Picograms per milliliter (pg/mL)||95% Confidence Interval|Geometric Mean
686061|NCT01494610|Secondary|Mean Plasma AUC(0-tau) and Plasma AUC From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC[0-tlast]) for Salmeterol|Blood samples of participants with asthma and COPD were collected and analyzed for AUC(0-tau) and AUC(0-tlast). AUC(0-tau) is a measure of the amount of drug available at target tissue (in plasma) for a fixed dosing interval (12 hours). AUC(0-tlast) is a measure of the plasma drug concentration from pre-dose to the last measurable concentration.|At pre-morning dose; 5, 10, 30 minutes post-dose (PD); and 1, 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|PK/PD Population||pg*h/mL||95% Confidence Interval|Geometric Mean
686062|NCT01494610|Primary|Weighted Mean Serum Cortisol (SC) Over 0 to 12 Hours Post Dose|Participants' blood samples were collected and analyzed for SC levels. Weighted mean SC levels are evaluted as a measure of the degree of cortisol suppression, allowing for the determination of whether differences in systemic exposure to the inhaled steroid component of two devices can be significant enough to result in the differences in the body’s ability to release cortisol. Weighted means were derived by calculating the AUC over the 0-12 hour period, using the linear trapezoidal rule (statistical technique used for numerical analysis) and then dividing it by the actual time interval.|At pre-morning dose; 30 minutes post-dose (PD); and 1, 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|PK/PD Population||Nanomoles per liter (nmol/L)||95% Confidence Interval|Geometric Mean
686063|NCT01494610|Primary|Mean Area Under the Concentration Time Curve Over the Dosing Period (AUC[0-tau]) for FP|Blood samples of participants (par.) with asthma and chronic obstructive pulmonary disease (COPD) were collected and analyzed for AUC(0-tau), a measure of the amount of drug available at target tissue (in plasma) for a fixed dosing interval (12 hours). Asthma is a disorder that causes the airways of the lungs to swell and narrow, leading to difficulty in breathing. COPD is a chronic lung disease with structural changes in lungs, leading to difficulty in breathing.|At pre-morning dose; 5, 10, 30 minutes post-dose (PD); and 1, 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|Pharmacokinetic/pharmacodynamic (PK/PD) Population: all participants who received at least one dose of study medication, except for one who was identified as a full protocol violator. Participants with at least one non-missing value in the replicate observations were included.||Picogram hours per milliliter (pg*h/mL)||95% Confidence Interval|Geometric Mean
686064|NCT01494584|Secondary|Number of Participants With the Indicated Neurological Abnormality|Abnormal Central Nervous System (CNS) symptoms were assessed by a full and brief neurological examination. A full neurological examination included assessment of mental status, cranial nerves, gait, coordination, sensation, speech/language, muscle strength, muscle tone, and reflexes. A brief neurological examination included assessment of mental status, cranial nerves, gait, coordination, reflexes, and speech/language. Neurological parameters assessed were memory impairment, impaired intellect, decreased attention, psychomotor slowing, decreased muscle strength, hpertonia, somnolence, right and left bicpes, right and left brachioradialis, right and left knee, right and left ankle, and right and left planter response. Neurological examination was performed at Day 7 of Titration 3 (600 mg/day).|Screening and Day 7 of Titration 3 (Day 21)|All Subjects Population||Participants|||Number
686065|NCT01494584|Secondary|Change From Baseline in Post Void Residual Ultrasound at Day 21|A post void residual (PVR) bladder ultrasound was carried out as a measure of bladder function. PVR was clinically indicated following the occurrence of adverse events relating to the lower urinary tract (e.g., micturition difficulties, including urinary hesitancy or urinary retention). These assessments were also repeated following drug withdrawal following such events. A prompt follow-up PVR was recommended if a high score was obtained from a participant on the Pediatric Lower Urinary Tract Symptom scale (the PLUTS scale is a clinician-rated scale used to assess lower urinary tract symptoms, including urinary retention) and if the clinician felt that the participant was at risk or had symptoms of urinary retention. PVR was measured at Day 7 of Titration 3 (600 mg/day). Baseline is defined as the Screening visit.|Screening and Day 7 of Titration 3 (Day 21)|All Subjects Population||ML||Standard Deviation|Mean
686066|NCT01494584|Secondary|Change From Baseline in Heart Rate (HR)|Vital sign assessment included heart rate measurement and was assessed at Titration 1 (T1; 300 mg/day): Day 1 pre-dose, Day 1 at 3 hours (h), pre-dose and 3 h post-dose. Titration 2 (T2; 450 mg/day): Day 7. Titration 3 (T3; 600 mg/day): pre-dose and 3 h post-dose. Titration 3 Dose Held (T3DH): pre-dose. Titration 4 (T4; 750 mg/day): Day 7. Titration 5 (T5; 900 mg/day): pre-dose and 3 h post-dose. Measurements were taken 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 14 for up-titration to 450 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 28 for up-titration to 750 mg/day dose; Day 35 for up-titration to 900 mg/day dose). Change from baseline was calculated by subtracting the baseline value from the individual post-dose values. Baseline is defined as as the Day 1 pre-dose value.|Baseline (Screening) and Day 7 post up-titration, up to Day 35|All Subjects Population. Only those par. available at the specified time points were analyzed(represented by n=X, X, X, X, X in the category titles). Different par. may have been analyzed at different time points and for different parameters, so the overall number of par. analyzed reflects everyone in the All Subjects Population.||Beats per Minute (BPM)||Standard Deviation|Mean
686067|NCT01494584|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points|Vital sign assessment included the measurement of systolic and diastolic blood pressure at Titration 1 (T1; 300 mg/day): Day 1 pre-dose, Day 1 at 3 hours (h), Day 7 pre-dose, and 3 h post dose. Titration 2 (T2; 450 mg/day): Day 7. Titration 3 (T3; 600 mg/day): Day 21 pre-dose and 3 h post-dose. Titration 3 Dose Held (T3DH): pre-dose. Titration 4 (T4; 750 mg/day): Day 7. Titration 5 (T5; 900 mg/day): Day 35 pre-dose and 3 h post-dose. Measurements were taken 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 14 for up-titration to 450 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 28 for up-titration to 750 mg/day dose; Day 35 for up-titration to 900 mg/day dose). Change from baseline was calculated by subtracting the baseline value from the individual post-dose values. Baseline is defined as as the Day 1 pre-dose value.|Baseline (Screening) and Day 7 post up-titration, up to Day 35|All Subjects Population. Only those par. available at the specified time points were analyzed(represented by n=X, X, X, X, X in the category titles). Different par. may have been analyzed at different time points and for different parameters, so the overall number of par. analyzed reflects everyone in the All Subjects Population.||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
686068|NCT01494584|Secondary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings|An ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QT interval corrected for heart rate (QTc intervals) was used. Measurements were taken 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 14 for up-titration to 450 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 28 for up-titration to 750 mg/day dose; Day 35 for up-titration to 900 mg/day dose). ECG parameters were assessed at Titration 1 (T1; 300 mg/day): Day 1 pre-dose, Day 1 at 3 hours (h), pre-dose, and 3 h post-dose. Titration 2 (T2; 450 mg/day): Day 7. Titration 3 (T3; 600 mg/day): pre-dose and 3 h post-dose. Titration 3 Dose Held (T3DH): pre-dose. Titration 4 (T4; 750 mg/day): Day 7. Titration 5 (T5; 900 mg/day): pre-dose and 3 h post-dose. The number of participants with abnormal (Abn) clinically significant (CS) and not clinically significant (NCS) ECG findings was recorded. The investigator determined if an ECG finding was CS or NCS.|Baseline (Screening) and Day 7 post up-titration, up to Day 35|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Participants|||Number
686069|NCT01494584|Secondary|Plasma Half Life at Steady State (t1/2) Following Oral Administration of Ezogabine/Retigabine|Blood samples were collected at pre-dose and at 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35 to assess plasma t1/2. Steady-state t1/2 is derived as (Vd/F) / (CL/F), where Vd/F is defined as the apparent volume of distribution after extravascular (e.g., oral) administration, and CL/F is defined as the apparent clearance following oral dosing.|Pre-dose and 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35|PK Population. Only those participants available at the indicated time point were analyzed.||Hours||95% Confidence Interval|Geometric Mean
686070|NCT01494584|Secondary|Time to Maximum Concentration (Tmax) Following Oral Administration of Ezogabine/Retigabine|Blood samples were collected at pre-dose and at 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35 to assess plasma Tmax.|Pre-dose and 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35|PK Population||Hours||Full Range|Median
686071|NCT01494584|Secondary|Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ctau) for the N-acetyl Metabolite of Ezogabine/Retigabine|Ctau refers to the pre-dose (trough) concentration at the end of the dosing interval which is equivalent to the minimum observed concetration (Cmin) at Steady State. Blood samples were collected at pre-dose and at 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35 to assess the Ctau for n-acetyl metabolite (NAMR) of ezogabine/retigabine following oral administration of ezogabine/retigabine.|Pre-dose and 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35|PK Population||ng/mL||95% Confidence Interval|Geometric Mean
686072|NCT01494584|Secondary|Area Under the Concentration-time Curve From Time Zero (Pre-dose) to the Last Time of Quantifiable Concentration (AUC [0-t]) for the N-acetyl Metabolite of Ezogabine/Retigabine|The area under the curve was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. Blood samples were collected at pre-dose and at 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35 to assess the plasma n-acetyl metabolite (NAMR) of ezogabine/retigabine following oral administration of ezogabine/retigabine.|Pre-dose and 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35|PK Population||h*ng/mL||95% Confidence Interval|Geometric Mean
686073|NCT01494584|Secondary|Percent Change From Baseline in 28-day Seizure Frequency Rate|Participants or their caregivers recorded the number of seizures experienced by the participant, by seizure type (e.g., simple partial seizure [seizure that affects only a small region of the brain; consciousness is unaffected], complex partial seizure [seizure associated with unilateral cerebral hemisphere involvement and causing impairment of awareness or responsiveness], etc.), as well as by duration of episodes of innumerable seizure activity, in their daily diaries during all phases of this study. Percent change from baseline is defined as 100 * (rate in a given period minus the baseline rate) / (baseline rate). baseline seizures are defined as those seizures that occurred after Screening and before the start of the treatment. Post-baseline seizures are defined as those seizures that occurred from the start of the treatment until the start of Follow-up. Seizure frequency rate was computed as: 28 * (number of seizures during given period / number of days in given period).|Baseline (Screening) and until Follow-up or early discontinuation (assessed up to 46 days)|All Subjects Population. Only participants with baseline and post-baseline seizure measurements were included in the analysis.||Percent change||Standard Deviation|Mean
686074|NCT01494584|Secondary|Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up|Urinalysis parameters analyzed included: urine occult blood (UOB), urine glucose (UG), urine ketones (UK), and urine protein (UP). The dipstick was a strip used to detect the presence or absence of these parameters in the urine sample. The dipstick test provides results in a semi-quantitative manner, and results can be read as negative (Neg), Trace, and 80, indicating proportional concentrations in the urine sample. Urinalysis parameters were assessed at Titration 1 (T1; 300 mg/day), Titration 2 (T2; 450 mg/day), Titration 3 (T3; 600 mg/day), Titration 4 (T4; 750 mg/day), and Titration 5 (T5; 900 mg/day).|Screening, Day 1 (D1), Day 7 (D7), Day 14 (D14), Day 21 (D21), Day 28 (D28), Day 35 (D35), and at the Follow-up Visit (up to Day 46)|All Subjects Population (ASP). Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X in the category titles). Different participants may have been analyzed at different time points and for different parameters, so the overall number of participants analyzed reflects everyone in the ASP.||Participants|||Number
686075|NCT01494584|Secondary|Change From Baseline in Red Blood Cell Count at Day 7 Post Each Up-titration|Change from baseline was calculated 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 35 for up-titration to 900 mg/day dose) by subtracting the baseline value from the individual post-dose values. Baseline is defined as the Screening visit.|Baseline (Screening), Day 7, Day 21, and Day 35|All Subjects Population. Only those participants available at the specified time point were analyzed.||10^12 cells/L (TI/L)||Standard Deviation|Mean
686098|NCT01494545|Secondary|Lens Surface Characteristics: Dry Areas/Non-wetting|The investigator assessed the surface of the contact lens while the lens was on the participant's eye for dry areas/non-wetting: 0=None; 1=Very Slight; 2-Slight; 3=Moderate; 4=Severe. Assessments were made individually (by eye) and binocularly (both eyes together).|Day 1|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.||Percentage of eyes|Participants||Number
686076|NCT01494584|Secondary|Change From Baseline in Mean Corpuscle Volume at Day 7 Post Each Up-titration|Change from baseline was calculated 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 35 for up-titration to 900 mg/day dose) by subtracting the baseline value from the individual post-dose values. Baseline is defined as the Screening visit.|Baseline (Screening), Day 7, Day 21, and Day 35|All Subjects Population. Only those participants available at the specified time point were analyzed.||Femtoliters (FL)||Standard Deviation|Mean
686077|NCT01494584|Secondary|Change From Baseline in Mean Corpuscle Hemoglobin at Day 7 Post Each Up-titration|Change from baseline was calculated 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 35 for up-titration to 900 mg/day dose) by subtracting the baseline value from the individual post-dose values. Baseline is defined as the Screening visit.|Baseline (Screening), Day 7, Day 21, and Day 35|All Subjects Population. Only those participants available at the specified time point were analyzed.||Picograms (PG) per cell (PG/cell)||Standard Deviation|Mean
686078|NCT01494584|Secondary|Change From Baseline in Hematocrit at Day 7 Post Each Up-titration|"Change from baseline was calculated 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 35 for up-titration to 900 mg/day dose) by subtracting the baseline value from the individual post-dose values. Baseline is defined as the Screening visit. The International System of Units (SI) Fraction of one unit (1) is reported here."|Baseline (Screening), Day 7, Day 21, and Day 35|All Subjects Population. Only those participants available at the specified time point were analyzed.||Fraction of one unit (1)||Standard Deviation|Mean
686079|NCT01494584|Secondary|Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration at Day 7 Post Each Up-titration|Change from baseline was calculated 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 35 for up-titration to 900 mg/day dose) by subtracting the baseline value from the individual post-dose values. Baseline is defined as the Screening visit.|Baseline (Screening), Day 7, Day 21, and Day 35|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Grams per liter (G/L)||Standard Deviation|Mean
686080|NCT01494584|Secondary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total ANC [Total Absolute Neutrophil Count]), Platelet Count, and White Blood Cell Count at Day 7 Post Each Up-titration|Change from baseline was calculated 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 35 for up-titration to 900 mg/day dose) by subtracting the baseline value from the individual post-dose values. Baseline is defined as the Screening visit.|Baseline (Screening), Day 7, Day 21, and Day 35|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Giga (10^9) cells per liter (GI/L)||Standard Deviation|Mean
686081|NCT01494584|Secondary|Change From Baseline in Calcium, Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (BUN) at Day 7 Post Each Up-titration|Change from baseline was calculated 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 35 for up-titration to 900 mg/day dose) by subtracting the baseline value from the individual post-dose values. Baseline is defined as the Screening visit.|Baseline (Screening), Day 7, Day 21, and Day 35|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Millimoles per liter (MMOL/L)||Standard Deviation|Mean
686082|NCT01494584|Secondary|Change From Baseline in Direct Bilirubin, Total Bilirubin, Creatinine, and Uric Acid at Day 7 Post Each Up-titration|Change from baseline was calculated 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 35 for up-titration to 900 mg/day dose) by subtracting the baseline value from the individual post-dose values. Baseline is defined as the Screening visit.|Baseline (Screening), Day 7, Day 21, and Day 35|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Micromoles per liter (UMOL/L)||Standard Deviation|Mean
686083|NCT01494584|Secondary|Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, and Gamma Glutamyl Transferase at Day 7 Post Each Up-titration|Change from baseline was calculated 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 35 for up-titration to 900 mg/day dose) by subtracting the baseline value from the individual post-dose values. Baseline is defined as the Screening visit.|Baseline (Screening), Day 7, Day 21, and Day 35|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||International Units per Liter (IU/L)||Standard Deviation|Mean
686084|NCT01494584|Secondary|Change From Baseline in Albumin and Total Protein at Day 7 Post Each Up-titration|Change from baseline was calculated 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 35 for up-titration to 900 mg/day dose) by subtracting the baseline value from the individual post-dose values. Baseline is defined as the Screening visit.|Baseline (Screening), Day 7, Day 21, and Day 35|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Grams per Liter (G/L)||Standard Deviation|Mean
686188|NCT01493089|Primary|Determination of Median Time to Sustained Partial Response as Defined by Reduction in Likert Severity Scale Used to Assess Pain Associated With Heartburn in the Patient|Reduction in severity of heartburn by 2 points or more on a 9-point Likert severity scale, which is sustained for 45 minutes or more|up to 14 days following treatment|mITT||Minutes||95% Confidence Interval|Median
686085|NCT01494584|Secondary|Number of Participants With Any Adverse Event (AE)|An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.|From the start of the first titration until follow-up (assessed up to 46 days)|All Subjects Population: all participants who received at least one dose of study medication||Participants|||Number
686086|NCT01494584|Primary|Apparent Volume of Distribution (Vd/F) Following Oral Administration of Ezogabine/Retigabine|The volume of distribution (Vd/F) is defined as MRT*CL/F, where MRT is the mean residence time (calculated as AUMC[0-tau]/AUC[0-tau], where AUMC[0-tau] is the area under the first moment curve determined as the area under the concentration*time versus time curve). Blood samples were collected at pre-dose and at 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35 to estimate the apparent volume of distribution.|Pre-dose and 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35|Pharmacokinetic Population. Only those participants available at the specified time points were analyzed.||Liters||95% Confidence Interval|Geometric Mean
686087|NCT01494584|Primary|Maximum Observed Concentration (Cmax) and Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ctau) Following Oral Administration of Ezogabine/Retigabine|Cmax is defined as the first occurrence of the maximum observed plasma concentration. Ctau refers to the pre-dose (trough) concentration after the dosing interval which is equal to the minimum observed concentration (Cmin) at Steady State. Blood samples were collected at pre-dose and at 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35 to estimate Cmax and Ctau.|Pre-dose and 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35|Pharmacokinetic Population||Nanograms/Milliliter (ng/mL)||95% Confidence Interval|Geometric Mean
686088|NCT01494584|Primary|Apparent Clearance (CL/F) Following Oral Administration of Ezogabine/Retigabine|Clearance (CL/F) is defined as dose/AUC(0-tau). Blood samples were collected at pre-dose and at 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35 to estimate CL/F.|Pre-dose and 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35|Pharmacokinetic Population||Liters/Hour||95% Confidence Interval|Geometric Mean
686089|NCT01494584|Primary|The Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) Following Oral Administration of Ezogabine/Retigabine|The steady state pharmacokinetic profile following oral administration of ezogabine/retigabine included determining the area under the curve over the dosing interval (AUC[0-tau]). The area under the plasma concentration-time curve over the dosing interval (AUC[0-tau]) was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. Blood samples were collected at pre-dose and at 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35 to estimate AUC(0-tau).|Pre-dose and 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35|Pharmacokinetic Population: all participants in the All Subjects Population (defined as all participants who received at least one dose of study medication) for whom a pharmacokinetic sample was obtained and analyzed||Hour*Nanograms/Milliliter (h.ng/mL)||95% Confidence Interval|Geometric Mean
686090|NCT01494545|Primary|Likert Statement: I am Interested in Purchasing These Contact Lenses.|The participant indicated purchase intent using a 4-point scale: 2=Very Interested; 1=Interested; -1=Not Interested; -2=Very Disinterested. A single assessment was made for both eyes.|Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.||Percentage of participants|||Number
686091|NCT01494545|Primary|Likert Statement: Compared to my Eye Glasses, my Vision With These Contact Lenses is:|The participant indicated overall satisfaction/dissatisfaction with the contact lenses using a 5-point scale: 2=Much Better; 1=A Little Better; 0=Same; -1=A Little Worse; -2=Much Worse. A single assessment was made for both eyes.|Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.||Percentage of participants|||Number
686092|NCT01494545|Secondary|Investigator's Rating of Ease of Fit|"The investigator indicated agreement/disagreement with the statement, The study lenses were easy to fit for this subject, by using a 4-point scale: 1=Strongly Agree; 2=Agree; 3=Disagree; 4=Strongly Disagree."|Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.||Percentage of participants|||Number
686093|NCT01494545|Secondary|Investigator's Overall Impression of Surface Wettability by Visit|The investigator rated his/her overall impression of the surface wettability of the contact lens on a 10-point scale (1=poor to 10=excellent).|Day 1, Day 7, Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.||Units on a scale||Standard Deviation|Mean
686094|NCT01494545|Secondary|Investigator's Satisfaction With Lens Fit by Visit|The investigator considered the factors that relate to a well-fitted contact lens, including good centration, adequate movement, and complete corneal coverage, and rated his/her satisfaction with the contact lens fit on 10-point scale, with 1 being not at all satisfied and 10 being very satisfied.|Day 1, Day 7, Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.||Units on a scale||Standard Deviation|Mean
686095|NCT01494545|Secondary|Duration of Overall Training Time|The investigator recorded the time it took for the patient to insert both lenses and remove both lenses, not including instructions.|Day 1|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.||Minutes||Standard Deviation|Mean
686096|NCT01494545|Secondary|Lens Surface Characteristics: Dry Areas/Non-Wetting|The investigator assessed the surface of the contact lens while the lens was on the participant's eye for dry areas/non-wetting: 0=None; 1=Very Slight; 2-Slight; 3=Moderate; 4=Severe. Assessments were made individually (by eye) and binocularly (both eyes together).|Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.||Percentage of eyes|Participants||Number
686097|NCT01494545|Secondary|Lens Surface Characteristics: Dry Areas/Non-Wetting|The investigator assessed the surface of the contact lens while the lens was on the participant's eye for dry areas/non-wetting: 0=None; 1=Very Slight; 2-Slight; 3=Moderate; 4=Severe. Assessments were made individually (by eye) and binocularly (both eyes together).|Day 7|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.||Percentage of eyes|Participants||Number
686099|NCT01494545|Primary|Likert Statement: My Peripheral Vision is Better With These Contact Lenses Than With my Eye Glasses.|The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.|Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.||Percentage of participants|||Number
686100|NCT01494545|Primary|Likert Statement: At the End of the Day my Vision is Better With These Contacts Lenses Compared to my Eye Glasses.|The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=strongly agree; 1=agree; -1=disagree; -2=strongly disagree. A single assessment was made for both eyes.|Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.||Percentage of participants|||Number
686101|NCT01494545|Primary|Likert Statement: Overall, my Vision is Better With These Contact Lenses Compared to my Eye Glasses.|The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.|Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.||Percentage of participants|||Number
686102|NCT01494545|Primary|Likert Statement: I Liked These Contact Lenses so Much That I Will Recommend Them to my Friends.|The participant indicated agreement/disagreement with the statement by using a 4-point scale: 22=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.|Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.||Percentage of participants|||Number
686103|NCT01494545|Primary|Likert Statement: These Contact Lenses Are Perfect for When I Choose Not to Wear my Eye Glasses.|The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.|Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.||Percentage of participants|||Number
686104|NCT01494545|Primary|Likert Statement: These Contact Lenses Felt so Comfortable That I Forgot I Was Wearing Them.|The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.|Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.||Percentage of participants|||Number
686105|NCT01494545|Primary|Likert Statement: These Contact Lenses Were so Comfortable That I Barely Felt Anything.|The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.|Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.||Percentage of participants|||Number
686106|NCT01494545|Primary|Likert Statement: These Contact Lenses Were so Comfortable That I Don't Feel Anything.|The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.|Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.||Percentage of participants|||Number
686107|NCT01494545|Primary|Average Comfortable Daily Wear Time by Visit|Average comfortable daily wear time was reported by the participant as a single, retrospective evaluation of the previous week of wear.|Day 7, Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.||Hours||Standard Deviation|Median
686108|NCT01494545|Primary|Overall Quality of Vision by Visit|Overall quality of vision was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Overall quality of vision was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.|Day 7, Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.||Units on a scale||Standard Deviation|Mean
686109|NCT01494545|Primary|Quality of Vision at End of Day by Visit|Quality of vision at end of day was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Quality of vision at end of day was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.|Day 7, Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.||Units on a scale||Standard Deviation|Mean
686110|NCT01494545|Primary|Quality of Vision During the Day by Visit|Quality of vision during the day was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Quality of vision during the day was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.|Day 7, Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.||Units on a scale||Standard Deviation|Mean
686111|NCT01494545|Primary|Quality of Vision at Insertion by Visit|Quality of vision at insertion was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Quality of vision at insertion was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.|Day 7, Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.||Units on a scale||Standard Deviation|Mean
686112|NCT01494545|Primary|Initial Quality of Vision|Initial quality of vision was rated by the participant and recorded on a questionnaire at time of lens dispense. Initial quality of vision was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.|Day 1|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.||Units on a scale||Standard Deviation|Mean
686113|NCT01494545|Primary|Overall Comfort by Visit|Overall comfort was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Overall comfort was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.|Day 7, Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.||Units on a scale||Standard Deviation|Mean
686114|NCT01494545|Primary|Comfort at End of Day by Visit|Comfort at end of day was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Comfort at end of day was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.|Day 7, Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.||Units on a scale||Standard Deviation|Mean
686115|NCT01494545|Primary|Comfort During the Day by Visit|Comfort during the day was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Comfort during the day was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.|Day 7, Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.||Units on a scale||Standard Deviation|Mean
686116|NCT01494545|Primary|Comfort at Insertion by Visit|Comfort at insertion was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Comfort at insertion was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.|Day 7, Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.||Units on a scale||Standard Deviation|Mean
686117|NCT01494545|Primary|Initial Comfort|Initial comfort was rated by the participant and recorded on a questionnaire at time of lens dispense. Initial comfort was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.|Day 1|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.||Units on a scale||Standard Deviation|Mean
686118|NCT01494532|Secondary|Percentage of Participants Withdrawn From the Study Due to Lack of Efficacy|The percentage of participants who withdrew from the study due to lack of efficacy as defined by either the participant or the investigator is presented here. All participants with a non-missing efficacy observation at Baseline and at least one post-Baseline efficacy assessment at any time during the study were analyzed.|From start of study treatment until end of treatment (assessed up to 18 weeks)|ITT Population. Participants with a non-missing efficacy observation at Baseline and at least one post-Baseline efficacy assessment at any time during the study were analyzed.||Percentage of participants|||Number
686119|NCT01494532|Secondary|Change From Baseline in UPDRS Part I at Week 4 of the Maintenance Period|"The UPDRS Part I scores mentation, behavior and mood as determined by a physician and par. were tested during the on phase of PD. This component of the UPDRS is the total score for 4 items (the items 1 to 4 include intellectual impairment, thought disorder, motivation / initiative, and depression) and may have a value ranging from 0 to 16 as determined by a physician. The higher score (16) indicates the maximum score and the worse condition. All 4 items have to be present for a total score to be calculated. If one or more items are missing, the total score for the component would also be missing. BL is defined as the last non-missing assessment measured on or before the first dose date. The change from BL was calculated by subtracting the BL values from the individual post-randomization values. LS means, 95% CIs and P-values were estimated from MMRM."|Baseline (BL) and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.||Score on scale||95% Confidence Interval|Least Squares Mean
686120|NCT01494532|Secondary|"Change From Baseline in UPDRS ADL Score With Participants in an Off State, at Week 4 of the Maintenance Period"|"The UPDRS Part II is the ADL score and can range from 0 to 52 as determined by the physician. The higher score indicates the worse condition. Test was performed when the par is in the off state of PD. The off time is defined as the state in which the participants' symptoms include lack of mobility (bradykinesia) with or without additional features such as tremor or rigidity. BL is defined as the last non-missing assessment measured on or before the first dose date. The change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values. LS means, 95% CIs and P-values were estimated from MMRM."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.||Score on scale||95% Confidence Interval|Least Squares Mean
686121|NCT01494532|Secondary|"Change From Baseline in UPDRS Activities of Daily Living (ADL) Score With Participants in an on State, at Week 4 of the Maintenance Period"|"The UPDRS Part II is the ADL score and can range from 0 to 52 as determined by the physician. The higher score indicates the worse condition. Test were performed when the par. is in the on state of PD. BL is defined as the last non-missing assessment measured on or before the first dose date. The change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values. LS means, 95% CIs and P-values were estimated from MMRM."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.||Score on scale||95% Confidence Interval|Least Squares Mean
686122|NCT01494532|Secondary|"Change From Baseline in Unified Parkinson Disease Rating Scale (UPDRS) Motor Score With Participants in an on State, at Week 4 of the Maintenance Period"|"The UPDRS is a clinician based rating scale used to measure motor impairments and disability. The UPDRS assesses six features of PD impairment. These are evaluated using a combination of data collected by interview and examination of the par.. One of the six features include the Part III-motor examination where scores can range 0 to 108 with par. in an on state where the maximum score indicates the worse condition. BL is defined as the last non-missing assessment measured on or before the first dose date. The change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values. LS means, 95% CIs and P-values were estimated from MMRM."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.||Score on scale||95% Confidence Interval|Least Squares Mean
686152|NCT01494467|Primary|Success Rate|"Percentage of subjects who achieve Clear (Score 0) or Almost Clear (Score 1) at Week 12 (ITT-LOCF) based on the Investigator Global Assessment (IGA) Score.
Evaluation of papulopustular rosacea will be performed by the investigator based on the following 5 point scale:
Clear = 0 (No inflammatory lesions present, no erythema); Almost Clear = 1 (Very few small papules/pustules, very mild erythema present); Mild = 2 (Few small papules/pustules, mild erythema); Moderate = 3 (Several small or large papules/pustules, moderate erythema); Severe = 4 (Numerous small and/or large papules/pustules, severe erythema)"|Week 12|LOCF, ITT||Percentage of participants|||Number
686123|NCT01494532|Secondary|Change From Baseline in Total Sleep Time During the Night Time Hours of Sleep as a Percentage of a 24-hour Day, at Week 4 of the Maintenance Period|"Par were asked to record awake time off, awake time on, TD during awake time on, or time asleep for all 30 minute time intervals in 24 hour diary cards for the 2 days preceding each visit of the study. The total sleep hours during the night time hours of sleep was the average across the 2 diary cards of the sum of time (hours) asleep during night time in each 24-hour diary card. The percentage of a 24-hour day spent asleep during the night time hours = Total sleep hours during the night time hours of sleep divided by 24 × 100. BL is defined as the last non-missing assessment measured on or before the first dose date. The change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values. LS means, 95% CIs and P-values were estimated from MMRM."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.||Percentage of time in hours||95% Confidence Interval|Least Squares Mean
686124|NCT01494532|Secondary|"Change From Baseline in the Percent of a 24-hour Day Spent on at Week 4 of the Maintenance Period"|"Par. were asked to record awake time off, awake time on, TD during awake time on, or time asleep for all 30 minute time intervals in 24 hour diary cards for the 2 days preceding each visit of the study. The total number of day awake hours spent on per 24-hour period was the average across the 2 diary cards of the sum of awake hours spent on in each 24-hour diary card. The percentage of a 24-hour day spent on = Awake time spent on divided by 24 × 100. BL is defined as the last non-missing assessment measured on or before the first dose date. The change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values. LS means, 95% CIs and P-values were estimated from MMRM."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.||"Percentage of on time in hours"||95% Confidence Interval|Least Squares Mean
686125|NCT01494532|Secondary|"Change From Baseline in the Percent of a 24- Hour Day Spent on Without TD at Week 4 of the Maintenance Period"|"Dyskinesias are involuntary twisting, turning movements caused by medication during on time in PD. TD is defined as those movements that interfere with function and cause meaningful discomfort. Par were asked to record awake time off, awake time on, TD during awake time on, or time asleep for all 30 minute time intervals in 24 hr diary cards for the 2 days preceding each visit. The total number of day awake hr spent on without TD per 24-hr period was the average across the 2 diary cards of the sum of awake hours spent on without TD in each 24-hour diary card. The percentage of 24 hr day spent on without TD= awake time spent on without TD divided by 24 × 100. BL is defined as the last non-missing assessment measured on or before the first dose date, change from BL was calculated by subtracting the BL values from the MP Week 4 values. LS means, 95% CIs and P-values were estimated from MMRM."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.||"Percentage of on time in hours"||95% Confidence Interval|Least Squares Mean
686126|NCT01494532|Secondary|"Change From Baseline in the Percent of a 24-hour Day Spent Off at Week 4 of the Maintenance Period"|"The off state is defined as the state in which the participants' symptoms include lack of mobility (bradykinesia), with or without additional features such as tremor or rigidity. Par were asked to record awake time off, awake time on, TD during awake time on, or time asleep for all 30 minute time intervals in 24 hour diary cards for the 2 days preceding each visit of the study. The total number of day awake hours spent off per 24-hour period was the average across the 2 diary cards of the sum of awake hours spent off in each 24-hour diary card. The percentage of 24 hour day spent off= awake time spent off divided by 24 x 100. BL is defined as the last non-missing assessment measured on or before the first dose date. The change from BL was calculated by subtracting the BL values from the MP Week 4 values. LS means, 95% CIs and P-values were estimated from MMRM."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.||"Percentage of off time in hours"||95% Confidence Interval|Least Squares Mean
686127|NCT01494532|Secondary|"Change From Baseline in the Percent Awake Time Spent on at Week 4 of the Maintenance Period"|"Par. were asked to record awake time off, awake time on, TD during awake time on, or time asleep for all 30 minute time intervals in 24 hour diary cards for the 2 days preceding each visit of the study. The total number of awake hours spent on per 24-hour period was the average across the 2 diary cards of the sum of awake hours spent on in each 24-hour diary card. The percentage of awake time spent on= Awake time spent on divided by (Awake time spent on + Awake time spent off) × 100. BL is defined as the last non-missing assessment measured on or before the first dose date. The change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values. LS means, 95% CIs and P-values were estimated from MMRM."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.||"Percentage of on time in hours"||95% Confidence Interval|Least Squares Mean
686128|NCT01494532|Secondary|"Change From Baseline in the Percent Awake Time Spent on Without TD at Week 4 of the Maintenance Period"|"Dyskinesias are involuntary twisting, turning movements caused by medication during “on” time in PD. TD is defined as those movements that interfere with function and cause meaningful discomfort. Par were asked to record awake time off, awake time on, TD during awake time on, or time asleep for all 30 minute time intervals in 24 hr diary cards for the 2 days preceding each visit of the study. The total number of awake hr spent on without TD per 24-hr period was the average across the 2 diary cards of the sum of awake hr spent on without TD in each 24-hr diary card. Percentage of awake time spent onwithout TD= Awake time spent on without TD divided by(Awake time spent on + Awake time spent off) × 100. BL is defined as the last non-missing assessment measured on or before the first dose date, change from BL was calculated by subtracting BL values from MP Week 4 values. LS means, 95% CIs and P-values were estimated from MMRM."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.||"Percentage of on time in hours"||95% Confidence Interval|Least Squares Mean
686187|NCT01493089|Secondary|Median Time to Sustained Partial Response|Reduction in severity of heartburn by 2 points or more on a 9-point Likert severity scale, which is sustained for 45 minutes or more|up to 14 days|mITT||Minutes||95% Confidence Interval|Median
686129|NCT01494532|Secondary|"Change From Baseline in the Percent Awake Time Spent Off at Week 4 of the Maintenance Period"|"The off state is defined as the state in which the participants' symptoms include lack of mobility(bradykinesia), with or without additional features such as tremor or rigidity. Par were asked to record awake time off, awake time on, TD during awake time on, or time asleep for all 30 minute time intervals in 24 hour diary cards for the 2 days preceding each visit of the study. The total number of awake hours spent off per 24-hour period was the average across the 2 diary cards of the sum of awake hours spent off in each 24-hour diary card. The percentage of awake time spent off= Awake time spent off divided by (Awake time spent off + Awake time spent on) × 100. BL is defined as the last non-missing assessment measured on or before the first dose date. The change from BL was calculated by subtracting the BL values from the MP Week 4 values. LS means, 95% CIs and P-values were estimated from MMRM."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.||"Percentage of off time in hours"||95% Confidence Interval|Least Squares Mean
686130|NCT01494532|Secondary|Percent Change From Baseline in Total Sleep Time During the Night Time Hours of Sleep, at Week 4 of the Maintenance Period|"Par. were asked to record awake time off, awake time on, TD during awake time on, or time asleep for all 30 minute time intervals in 24 hour diary cards for the 2 days preceding each visit of the study. The total sleep hours during the night time hours of sleep was the average across the 2 diary cards of the sum of time (hours) asleep during night time in each 24-hour diary card. BL is defined as the last non-missing assessment measured on or before the first dose date. The percent change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values divided by BL value × 100. LS means, 95% CIs and P-values were estimated from MMRM."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.||Percentage of total sleep time in hours||95% Confidence Interval|Least Squares Mean
686131|NCT01494532|Secondary|"Percent Change From Baseline in Awake Time Spent on at Week 4 of the Maintenance Period"|"Par. were asked to recordawake time off, awake time on, TD during awake time on, or time asleep for all 30 minute time intervals in 24 hour diary cards for the 2 days preceding each visit of the study. The total number of awake hours spent on per 24-hour period was the average across the 2 diary cards of the sum of awake hours spent on in each 24-hour diary card. The percent change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values divided by BL values × 100. LS means, 95% CIs and P-values were estimated from MMRM."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.||"Percentage of on time in hours"||95% Confidence Interval|Least Squares Mean
686132|NCT01494532|Secondary|"Percent Change From Baseline in Awake Time Spent on Without TD at Week 4 of the Maintenance Period"|"Dyskinesias are involuntary twisting, turning movements caused by medication during on time in PD. TD is defined as those movements that interfere with function and cause meaningful discomfort. Par. were asked to record awake time off, awake time on, TD during awake time on, or time asleep for all 30 minute time intervals in 24 hour diary cards for the 2 days preceding each visit of the study. The total number of awake hours spent on without TD per 24-hour period was the average across the 2 diary cards of the sum of awake hours spent on without TD in each 24-hour diary card. The percent change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values divided by BL values × 100. LS means, 95% CIs and P-values were estimated from MMRM."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.||"Percentage of on time in hours"||95% Confidence Interval|Least Squares Mean
686133|NCT01494532|Secondary|"Percent Change From Baseline in Awake Time Spent Off at Week 4 of the Maintenance Period"|"The off state is defined as the state in which the participants' symptoms include lack of mobility (bradykinesia), with or without additional features such as tremor or rigidity. Par. were asked to record awake time off, awake time on, TD during awake time on, or time asleep for all 30 minute time intervals in 24 hour diary cards for the 2 days preceding each visit of the study. The total number of awake hours spent off per 24-hour period was the average across the 2 diary cards of the sum of awake hours spent off in each 24-hour diary card. The percent change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values divided by BL values multiplied (×) the results with 100. LS means, 95% CIs and P-values were estimated from MMRM."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.||"Percentage of off time in hours"||95% Confidence Interval|Least Squares Mean
686134|NCT01494532|Secondary|Change From Baseline for Total Sleep Time During the Night Time Hours of Sleep at Week 4 of the Maintenance Period|"Par. were asked to record awake time off, awake time on, TD during awake time on, or time asleep for all 30 minute time intervals in 24 hour diary cards for the 2 days preceding each visit of the study. The total sleep hours during the night time hours of sleep was the average across the 2 diary cards of the sum of time (hours) asleep during night time in each 24-hour diary card. BL is defined as the last non-missing assessment measured on or before the first dose date. The change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values. LS means, 95% CIs and P-values were estimated from MMRM."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.||Hours||95% Confidence Interval|Least Squares Mean
686135|NCT01494532|Secondary|"Change From Baseline in Absolute Awake Time Spent on at Week 4 of the Maintenance Period"|"Par were asked to record awake time off, awake time on, TD during awake time on, or time asleep for all 30 minute time intervals in 24 hour diary cards for the 2 days preceding each visit of the study. The total number of awake hours spent on per 24-hour period was the average across the 2 diary cards of the sum of the awake hours spent on in each 24 hour diary card. BL is defined as the last non-missing assessment measured on or before the first dose date. The change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values. LS means, 95% CIs and P-values were estimated from MMRM."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.||Hours||95% Confidence Interval|Least Squares Mean
686136|NCT01494532|Secondary|"Change From Baseline in Absolute Awake Time Spent on Without Troublesome Dyskinesia (TD) at Week 4 of the Maintenance Period"|"Dyskinesias are involuntary twisting, turning movements caused by medication during “on” time in Parkinson's Disease (PD). TD is defined as those movements that interfere with function and cause meaningful discomfort. Par were asked to record awake time off, awake time on, TD during awake time on, or time asleep for all 30 minute time intervals in 24 hour diary cards for the 2 days preceding each visit. The total number of awake hours spent on without TD per 24-hour period was the average across the 2 diary cards of the sum of awake hours spent on without TD in each 24 hour diary card. The change from BL was calculated by subtracting the BL values from the MP Week 4 values. LS means, 95% CIs and P-values were estimated from Mixed Model Repeated Measures (MMRM). Par with a non-missing efficacy observation at BL and during the MP were analyzed."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.||Hours||95% Confidence Interval|Least Squares Mean
686137|NCT01494532|Secondary|Responder Rate According to the Clinical Global Impression-global Improvement (CGI-I) Scale at Week 4 of the Maintenance Period|"The CGI-I scale allows the investigator to rate the participant's total improvement since the beginning of treatment (Baseline). Baseline is defined as the last non-missing assessment measured on or before the first dose date. The scale is rated from 1-7 where 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. The responder rate is defined as the percentage of participants with a score of 1 or 2. The Generalized Estimating Equations (GEE) model was used to determine CGI responder rate with treatment, visit, and treatment by visit interaction included in the model. Only scheduled visits were included."|Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.||Percentage of participants|||Number
686138|NCT01494532|Secondary|"Percentage of Participants With a >=2 Hours Reduction in Baseline Off Time at Week 4 of the Maintenance Period"|"The off time is defined as the state in which the participants' symptoms include lack of mobility (bradykinesia) with or without additional features such as tremor or rigidity. BL is defined as the last non-missing assessment measured on or before the first dose date. The percent change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values. Percentage of participants meeting the criterion (LS mean on inverse linked scale), odds ratio with 95% CI and p-value comparing against placebo were estimated by Generalized Estimating Equations (GEE) model. Baseline 'off-time', treatment, visit and treatment*visit are included in the model."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.||percentage of participants||95% Confidence Interval|Least Squares Mean
686139|NCT01494532|Secondary|"Percentage of Participants With a >=1 Hour Reduction in Baseline Off Time at Week 4 of the Maintenance Period"|"The off time is defined as the state in which the participants' symptoms include lack of mobility (bradykinesia) with or without additional features such as tremor or rigidity. BL is defined as the last non-missing assessment measured on or before the first dose date. The percent change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values. Percentage of participants meeting the criterion (LS mean on inverse linked scale), odds ratio with 95% CI and p-value comparing against placebo were estimated by Generalized Estimating Equations (GEE) model. Baseline 'off-time', treatment, visit and treatment*visit are included in the model."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.||percentage of participants||95% Confidence Interval|Least Squares Mean
686140|NCT01494532|Secondary|"Responder Rate Defined as the Percentage of Participants With a 20% Reduction in Baseline (BL) Off Time at Week-4 of Maintenance Period"|"The responder rate was defined as the percentage of par with greater than or equal to (>=) 20 percent (%) reduction in their individual BL off time at Week 4 of the Maintenance Period. The off time is defined as the state in which the participants' symptoms include lack of mobility (bradykinesia) with or without additional features such as tremor or rigidity. BL is defined as the last non-missing assessment measured on or before the first dose date. Responder Rate (Least Squares [LS] means on inverse linked scale), odds ratio with 95% CI and p-value comparing against placebo were estimated by Generalized Estimating Equations (GEE) model. Baseline total awake time 'Off', treatment, visit and treatment*visit are included in the model."|Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.||percentage of participants||95% Confidence Interval|Least Squares Mean
686141|NCT01494532|Primary|"Change From Baseline (BL) in Total Awake Time Spent Off at Week 4 of Maintenance Period"|"Off time is defined as the state in which the participants(par) symptoms include lack of mobility(bradykinesia) with or without additional features such as tremor or rigidity. Par were asked to record awake time “off ”, awake time on, troublesome dyskinesias(TD) during awake time on, or time asleep for 30 minute intervals in 24 hr diary cards for 2 days preceding visits. Total number of awake hrs spent off per 24-hr period was the average of the 2 diary cards of the sum of awake hours spent off in each 24-hr diary card. BL is the last non-missing assessment measured on or before the first dose, change from BL was calculated by subtracting the BL values from the MP Week 4 values. Mixed Model Repeated Measures (MMRM) model used BL total awake time 'Off', treatment, visit and treatment by visit"|Baseline and Week 4 of the Maintenance Period (Study Week 17)|The Intent to Treat(ITT) Population included all randomized par who received at least one dose of study medication, had a BL efficacy assessment for the outcome, and at least one respective Post-BL efficacy assessment. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.||Hours||95% Confidence Interval|Least Squares Mean
686142|NCT01494506|Secondary|Pharmacokinetic Measurements of Total Irinotecan|Plasma concentration-time data for MM-398 will be analyzed using population pharmacokinetic methods.|6 weeks after first study drug administration|PK population was based on Protocol, all participants who received the appropriate dose of MM-398.||Total irinotecan = ug/L; SN38= ug/L||Geometric Coefficient of Variation|Geometric Mean
686143|NCT01494506|Secondary|EORTC-QLQ-C30|This patient recorded outcome consists of 15 subscales in 3 independent domains: global health-related quality of life (HRQoL), functional scales (cognitive, emotional, physical, role and social functioning), and symptom scales (appetite loss, constipation, diarrhea, dyspnea, fatigue, insomnia, nausea and vomiting, and pain). For each subscale, patients were classified as improved, worsened or stable. Improvement is indicated by achievement of subscale score at least 10% improved from baseline and maintained for at least 6 weeks. Worsened is indicated by subscale score at least 10% worse than baseline. Stable is indicated by neither improvement nor worsened. Achievement of improvement prior to worsening was classified as improvement.|Baseline to treatment discontinuation every 6 weeks; The maximum time in follow up was 25 months|ITT patients who had baseline and at least one-post baseline EORTC-QLQ-C30 assessment.||percent of patients in category|||Number
686144|NCT01494506|Secondary|Percentage of Patients With Tumor Marker (CA 19-9) Response|Tumor marker response (TMR) was evaluated by the change in CA19-9 serum levels. Response was defined as a decrease of 50% of CA19-9 in relation to the baseline level at least once during the treatment period.|Baseline to treatment discontinuation every 6 weeks; The maximum time in follow up was 25 months|Patients with elevated baseline CA19-9 value (> 30 U/mL) who received study drug.||percent of participants with TMR|||Number
686145|NCT01494506|Secondary|Percentage of Patients With Clinical Benefit Response|"Composite measure based on patient-reported pain (per VAS), patient-reported pain medication, KPS, and weight. Clinical benefit is indicated by either:
(a) improvement in pain (less pain intensity with stable or decreased pain medication; or less pain medication with stable or decreased pain intensity) with stable or improved KPS; or (b) improvement in KPS with stable or improved pain.
With stable for KPS and pain, clinical benefit may be indicated with an observation of positive weight change.
Clinical benefit response (CBR) was classified weekly and a patient was considered a clinical benefit responder if clinical benefit was observed and maintained over a 4 week period."|Randomization to treatment discontinuation.The maximum time in follow up was 25 months|"Clinical Benefit Response Evaluable Population: Patients who received study drug and met at least one of the following criteria were defined as eligible for evaluation of CBR:
baseline pain intensity ≥ 20 (out of 100)
baseline morphine consumption ≥ 10 mg/day PO morphine equivalents
baseline KPS of 70 to 90 points"||percentage of participants with CBR|||Number
686146|NCT01494506|Secondary|Time to Treatment Failure|Time from randomization to discontinuation of treatment for any reason, including disease progression, treatment toxicity or death.|Randomization to treatment discontinuation (any cause). The maximum time in follow up was 25 months|ITT Population||months||95% Confidence Interval|Median
686147|NCT01494506|Secondary|Objective Response Rate|The objective response rate was a secondary efficacy endpoint of the study and was defined by the percentage of patients in the study population with a best overall response of Complete Response (CR) or Partial Response (PR) as assessed by the investigator. Best overall response was defined per RECIST (version 1.1) recorded from randomization until progression or end of study. RECIST (v 1.1) criteria does not require confirmation of response, but an additional, more stringent analysis was also conducted, with designation of CR (or PR) requiring confirmation of response at least 4 weeks following the initial assessment of CR (or PR). Stable disease (SD) required an assessment of SD at least 6 weeks after starting treatment. Subjects with insufficient data for response classification were classified as Not Evaluable for best overall response, and as a non-responder for objective response, in the ITT population. Treatment groups are as indicated for the primary outcome of OS.|Assessment every 6 weeks after initial response; Day 1 to data cut off of 14 Feb 2014; maximum time on study 25 months.|ITT Population||percentage with confirmed response||95% Confidence Interval|Number
686148|NCT01494506|Secondary|Progression Free Survival|"Progression-free survival was defined as the time from the date of randomization to the date of disease progression, or death (any cause) on or prior to the clinical cutoff date, whichever occurred earlier. Participants who did not have disease progression or had not died were censored at the date of the last tumor assessment. Patients with two or more consecutive missing response assessments prior to a visit with documented progression (or death) were censored at the last date of tumor assessment when the patient was documented to be progression free. PFS was summarized using Kaplan-Meier methods.
The comparison of Arm C is based only on patients who were randomized under the 3-arm version of the protocol. Consequently, the 5-FU+Leucovorin (Combo Therapy Comparison) group is a subset of all patients randomized to 5-FU+Leucovorin, which is the Mono Therapy Comparison control and contains patients randomized under both the 2-arm and 3-arm versions of the protocol."|Randomization until disease progression or death from any cause; Until the data cut off of 14 Feb 2014. The maximum time in follow up was 25 months.|ITT Population||months||95% Confidence Interval|Median
686149|NCT01494506|Primary|Overall Survival|"Overall survival was the primary efficacy endpoint of the study and was defined as the time from the date of patient randomization to the date of death or the date the patient was last known to be alive. OS was summarized by Kaplan-Meier methodology for each treatment group. Pairwise treatment group comparisons were carried out using unstratified log rank analyses on the ITT population. Hazard ratio estimates are from Cox regression analysis.
The comparison of Arm C is based only on patients who were randomized under the 3-arm version of the protocol. Consequently, the 5-FU+Leucovorin (Combo Therapy Comparison) group is a subset of all patients randomized to 5-FU+Leucovorin, which is the Mono Therapy Comparison control and contains patients randomized under both the 2-arm and 3-arm versions of the protocol."|From randomization to death; until the data cut off 14 Feb 2014. The maximum time in follow up was 25 months.|Intent to Treat population (ITT population) consisted of all randomized participants. Efficacy analyses in the ITT population consider treatment group according to randomization. Comparisons of the MM-398+5-FU/LV to 5-FU/LV were carried out only on patients who were randomized under protocol version 2 or later.||months||95% Confidence Interval|Median
686150|NCT01494467|Secondary|Percent Change in Inflammatory Lesion Count From Baseline to Week 12 (ITT-LOCF)|Inflammatory lesion counts were conducted at each visit by the Investigator or study coordinator. Papules and pustules were counted separately on each of the five facial regions (forehead, chin, nose, right cheek, left cheek).|Baseline to Week 12|||Percentage of change in lesion counts||Standard Deviation|Mean
686151|NCT01494467|Primary|Absolute Change in Inflammatory Lesion Count|Inflammatory lesion counts were conducted at each visit by the Investigator or study coordinator. Papules and pustules were counted separately on each of the five facial regions (forehead, chin, nose, right cheek, left cheek).|Baseline to Week 12|LOCF, ITT||Lesion count change||Standard Deviation|Mean
686153|NCT01493180|Primary|Change in the Keratoconjunctival Staining Score From Baseline|"Keratoconjunctival staining indicates the damage to the corneal and conjunctival epithelium. The cornea and conjunctiva were divided into 3 and 2 fractions, respectively, each of which was given a staining score from 0 to 3, and the total score was calculated (0-15). 0 is better.
The change from baseline at the end of instillation (LOCF) in the keratoconjunctival staining score were compared between the 2% rebamipide group and the 0.1% sodium hyaluronate group using a t-test."|Basekine, 4 weeks|||scores on a scale||Standard Deviation|Mean
686154|NCT01494350|Secondary|Number of All Ulcerated Lesions With Reepithelialization on Day 28|Final cure rate for all ulcerated lesions (100% reepithelialization for ulcerative lesions) on Day 28|Measured on day 28|modified intent to treat (mITT). This outcome measure does not include one subject (2 lesions) who withdrew on Day 18.||lesions|Participants||Number
686155|NCT01494350|Secondary|Area of All Ulcerated Lesions Throughout the Study|Area of all ulcerated lesions on Days 20, 28, 42, and 98.|Measured at day 20, 28, 42 and 98|modified intent to treat (mITT). Baseline for this outcome measure does not include one subject (2 lesions) who withdrew on Day 18.||mm^2|Participants|Standard Deviation|Mean
686156|NCT01494350|Secondary|Number of Index Lesions With Reepithelialization Throughout the Study|Number of index lesions with 100% reepithelialization on Days 28 and 42.|Measured at day 28 and 42|modified intent to treat (mITT). This outcome measure does not include one subject (2 lesions) who withdrew on Day 18.||lesions|Participants||Number
686157|NCT01494350|Secondary|Area of Index Lesions Throughout the Study|Area (mm^2) of index lesion on Days 0, 20, 28, 42, and 98.|Measured at day 0, 20, 28, 42, and 98|modified intent to treat (mITT). Baseline for this outcome measure does not include one subject (1 index lesion) who withdrew on Day 18.||mm^2|Participants|Standard Deviation|Mean
686158|NCT01494350|Primary|Final Clinical Cure Rate for the Index Lesion|Number of index lesions with 100% reepithelialization at Day 98.|Final clincial cure is measured at day 98|modified intent to treat (mITT)||lesions|Participants||Number
686159|NCT01494298|Secondary|Lipoprotein a [Lp(a)] in African Americans With Diabetes and Without.||at study entry|||mg/dL||Standard Error|Least Squares Mean
686160|NCT01494298|Secondary|LDL Density in African American Males With Diabetes and Those Without Diabetes|"LDL size subclassification was divided into the following groups (from largest size to smallest size): LDL I, LDL IIa, LDL IIb, LDL IIIa, LDL IIIb, LDL IVa, LDL IVa, and LDL IVb.
For differences posted P<0.05 for LDL I, LDL IIb, LDL IIIa, and LDL IIIa +b"|at entry|||percentage of total LDL particles||Standard Error|Least Squares Mean
686161|NCT01494298|Primary|ApoB Levels in African American Men With Diabetes and Those Without.|Apolipoprotein B Age adjusted least square means are reported because of baseline differences in ages.|At study entry|||mg/dL||Standard Error|Least Squares Mean
686162|NCT01493947|Other Pre-specified|Time to Relapse|Relapse define as time elapsed between Week 16 and first reoccurrence of Investigator Global assessement (IGA) at '2 (mild)' , '3 (moderate)' or '4 (severe)'.|Week 16 up to Week 52|||Median days to relapse||95% Confidence Interval|Median
686163|NCT01493947|Primary|Percent Change in Inflammatory Lesions From Baseline to Week 16|Efficacy of Ivermectin versus Metronidazole as determined by the percent change in inflammatory lesions after a 16-week treatment period|Baseline and Week 16|||percentage of change||Standard Deviation|Mean
686164|NCT01493687|Secondary|Percent Change in Inflammatory Lesion Count From Baseline to Week 12 (ITT-LOCF)|Inflammatory lesion counts were conducted at each visit by the Investigator or study coordinator. Papules and pustules were counted separately on each of the five facial regions (forehead, chin, nose, right cheek, left cheek).|Baseline to Week 12|LOCF, ITT||Percentage of change in lesion counts||Standard Deviation|Mean
686165|NCT01493687|Primary|Absolute Change in Inflammatory Lesion Count|Inflammatory lesion counts were conducted at each visit by the Investigator or study coordinator. Papules and pustules were counted separately on each of the five facial regions (forehead, chin, nose, right cheek, left cheek).|Baseline to Week 12|LOCF, ITT||Lesion count change||Standard Deviation|Mean
686166|NCT01493687|Primary|Success Rate|"Percentage of subjects who achieve Clear (Score 0) or Almost Clear (Score 1) at Week 12 (ITT-LOCF) based on the Investigator Global Assessment (IGA) Score.
Evaluation of papulopustular rosacea will be performed by the investigator based on the following 5 point scale:
Clear = 0 (No inflammatory lesions present, no erythema); Almost Clear = 1 (Very few small papules/pustules, very mild erythema present); Mild = 2 (Few small papules/pustules, mild erythema); Moderate = 3 (Several small or large papules/pustules, moderate erythema); Severe = 4 (Numerous small and/or large papules/pustules, severe erythema)"|Week 12|LOCF, ITT||Percentage of participants|||Number
686167|NCT01493557|Secondary|Time Between Symptom Onset and First Observed Complete or Partial Effectiveness and Between Symptom Onset and Last Observed Symptom|Time between symptom onset and first observed complete or partial effectiveness and between symptom onset and last observed symptom by management strategy.|Week 8|Full Analysis Set (FAS)||days||Standard Deviation|Mean
686168|NCT01493557|Secondary|Rates of Complete or Partial Effectiveness of GIS at Each Visit.|"The percentage of patients experiencing complete or partial effectiveness of gastrointestinal symptoms (GIS) at each visit by management strategy.
Evaluation of GIS was based on Last observation carried forward (LOCF) data up to the last observed time or up to adding the second management strategy."|Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 & Week 8|Full Analysis Set (FAS).||percentage of participants|||Number
686169|NCT01493557|Secondary|Rates of Partial Effectiveness of GIS at Each Visit.|"The percentage of patients experiencing partial effectiveness of gastrointestinal symptoms (GIS) at each visit by management strategy.
Evaluation of GIS was based on Last observation carried forward (LOCF) data up to the last observed time or up to adding the second management strategy."|Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 & Week 8|Full Analysis Set (FAS)||percentage of participants|||Number
686170|NCT01493557|Secondary|Rates of Complete Effectiveness of GIS at Each Visit.|"The percentage of patients experiencing complete effectiveness of gastrointestinal symptoms (GIS) at each visit by management strategy.
Evaluation of GIS was based on Last observation carried forward (LOCF) data up to the last observed time or up to adding the second management strategy."|Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 & Week 8|Full analysis Set (FAS).||percentage of participants|||Number
686671|NCT01487499|Primary|Solid Tumor Growth After Completion of Interventional Bronchoscopies|The Organization for Research and Treatment of Cancer Response Evaluation Criteria in Solid Tumors (RECIST) system will be used to grade the response to therapy.|18 months|No participants were analyzed because total enrollment numbers were too low to meet any statistical analysis.|||||
686171|NCT01493557|Secondary|Combined Rate of Complete or Partial Effectiveness of Combined GIS Management Strategies|"The percentage of patients experiencing combined of complete or partial relief of gastrointestinal symptoms (GIS) when taking pantoprazole 40 mg once daily in the morning (q.a.m.) vs. administration of Pradaxa ® (dabigatran etexilate) within 30 minutes after a meal.
Complete effectiveness is defined as at the time of evaluation, both primary GIS and secondary GIS are all resolved. Partial effectiveness is defined as at the time of evaluation, either primary GIS is improved; or primary GIS is resolved, but there were still un−resolved secondary GIS."|Week 8|Full Analysis Set (FAS)||percentage of participants|||Number
686172|NCT01493557|Secondary|Rate of Partial Effectiveness of Combined GIS Management Strategies|"The percentage of patients experiencing partial relief of gastrointestinal symptoms (GIS) when taking pantoprazole 40 mg once daily in the morning (q.a.m.) vs. administration of Pradaxa ® (dabigatran etexilate) within 30 minutes after a meal at 4 weeks.
Partial effectiveness is defined as at the time of evaluation, either primary GIS is improved; or primary GIS is resolved, but there were still un−resolved secondary GIS."|Week 8|Full Analysis Set (FAS)||percentage of participants|||Number
686173|NCT01493557|Secondary|Rate of Complete Effectiveness of Combined GIS Management Strategies|"The percentage of patients experiencing complete relief of combined gastrointestinal symptoms (GIS) when taking pantoprazole 40 mg once daily in the morning (q.a.m.) vs. administration of Pradaxa ® (dabigatran etexilate) within 30 minutes after a meal.
Complete effectiveness is defined as at the time of evaluation, both primary GIS and secondary GIS are all resolved."|Week 8|Full Analysis Set (FAS)||percentage of participants|||Number
686174|NCT01493557|Secondary|Combined Rate of Complete or Partial Effectiveness of Initial GIS Management Strategies|"The percentage of patients experiencing complete or partial effectiveness of gastrointestinal symptoms (GIS) when taking pantoprazole 40 mg once daily in the morning (q.a.m.) vs. administration of Pradaxa ® (dabigatran etexilate) within 30 minutes after a meal at 4 weeks.
Complete effectiveness is defined as at the time of evaluation, both primary GIS and secondary GIS are all resolved. Partial effectiveness is defined as at the time of evaluation, either primary GIS is improved; or primary GIS is resolved, but there were still un−resolved secondary GIS."|Week 4|Full Analysis Set (FAS)||percentage of participants|||Number
686175|NCT01493557|Secondary|Rate of Partial Effectiveness of Initial GIS Management Strategies|"The percentage of patients experiencing partial relief of gastrointestinal symptoms (GIS) when taking pantoprazole 40 mg once daily in the morning (q.a.m.) and patients taking Pradaxa® (dabigatran etexilate) within 30 minutes after a meal at 4 weeks.
Partial effectiveness is defined as at the time of evaluation, either primary GIS is improved; or primary GIS is resolved, but there were still un−resolved secondary GIS."|Week 4|Full Analysis Set (FAS)||percentage of participants|||Number
686176|NCT01493557|Primary|The Rate of Complete Effectiveness of Initial GIS Management Strategy|"The percentage of patients experiencing complete relief of gastrointestinal symptoms (GIS) when taking pantoprazole 40 mg once daily in the morning (q.a.m.) vs. administration of Pradaxa® (dabigatran etexilate) within 30 minutes after a meal at 4 weeks.
Complete effectiveness is defined as at the time of evaluation, both primary GIS and secondary GIS are all resolved."|Week 4|Full Analysis Set (FAS): This patient set included all patients who developed GIS and who were randomized into the two management strategies.||percentage of participants|||Number
686177|NCT01493531|Secondary|Subjects With ≥ 1 Target Tophus at Baseline Who Experience Complete Resolution of at Least 1 Target Tophus by Month 12|Proportion of subjects with ≥ 1 target tophus at Baseline who experience complete resolution of at least 1 target tophus by Month 12|12 months|||Proportion of Subjects|||Number
686178|NCT01493531|Secondary|Gout Flares|Mean rate of gout flares requiring treatment for the 6-month period from the end of Month 6 to the end of Month 12.|12 Months|||Gout Flares||Standard Deviation|Mean
686179|NCT01493531|Primary|Subjects With a Serum Urate (sUA) < 6.0 mg/dL by Month 6.|Proportion of subjects with an sUA level that is < 6.0 mg/dL by Month 6.|6 months|Intent-to-Treat Population||Proportion of Subjects|||Number
686180|NCT01493427|Secondary|Percentage of Patients With Target IOP (≤18 mmHg) at 12 Weeks|IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.|Week 12|The Full Analysis Set (FA) included all subjects who instilled at least one drop of study product and who had primary endpoints measures available for at least one on-therapy study visit.||Percentage of participants|||Number
686181|NCT01493427|Primary|Mean Change in Intraocular Pressure (IOP) at 12 Weeks From Prior Therapy (Baseline)|IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.|Baseline, Week 12|"The Full Analysis Set (FA) included all subjects who instilled at least one drop of study product and who had primary endpoints measures available for at least one on-therapy study visit (N=187). Here, n is the number of participants with non-missing values at the specific time point."||millimeters mercury (mmHg)||Standard Deviation|Mean
686182|NCT01493167|Primary|Efficient Casting With Woodcast Circular System|Efficient casting conduc ted with Novel Woodcast material|1 - 6 weeks|||participants|||Number
686183|NCT01493089|Secondary|Percentage of Patients Responding in 90 Minutes|Proportion of patients who have achieved sustained response, sustained partial response or sustained total relief by 90 minutes|14 days|mITT||Percentage of patients||95% Confidence Interval|Number
686184|NCT01493089|Secondary|Percentage of Patients Responding in 60 Minutes|Proportion of patients who have achieved sustained response, sustained partial response or sustained total relief by 60 minutes|14 days|mITT||Percentage of patients||95% Confidence Interval|Number
686185|NCT01493089|Secondary|Percentage of Patients Responding in 45 Minutes|percentage of patients who have achieved sustained partial response, sustained response, or sustained total relief, by 45 minutes|up to 14 days|mITT||percentage of patients||95% Confidence Interval|Number
686186|NCT01493089|Secondary|Median Time to Sustained Total Relief|Time to sustained total relief, defined as zero severity (no heartburn) on a 9-point Likert severity scale, which is sustained for 45 minutes or more|14 days|mITT||Minutes||95% Confidence Interval|Median
686189|NCT01492439|Secondary|The Digit Vigilance Test at 6 Months|The Digit Vigilance test measures sustained attention/vigilance. Participants are asked to cross out either 6s or 9s which appear randomly within 59 rows of 35 single digits. Scores are calculated for Total Time and Total Errors, with higher scores indicating greater impairment.|6 months following baseline assessment|||Seconds||Standard Deviation|Mean
686190|NCT01492439|Secondary|The Digit Vigilance Test at 6 Months|The Digit Vigilance test measures sustained attention/vigilance. Participants are asked to cross out either 6s or 9s which appear randomly within 59 rows of 35 single digits. Scores are calculated for Total Time and Total Errors, with higher scores indicating greater impairment.|6 months following baseline assessment|||Incorrect Responses||Standard Deviation|Mean
686191|NCT01492439|Secondary|The Digit Vigilance Test at 3 Months|The Digit Vigilance test measures sustained attention/vigilance. Participants are asked to cross out either 6s or 9s which appear randomly within 59 rows of 35 single digits. Scores are calculated for Total Time and Total Errors, with higher scores indicating greater impairment.|3 months following baseline assessment|||Seconds||Standard Deviation|Mean
686192|NCT01492439|Secondary|The Digit Vigilance Test at 3 Months|The Digit Vigilance test measures sustained attention/vigilance. Participants are asked to cross out either 6s or 9s which appear randomly within 59 rows of 35 single digits. Scores are calculated for Total Time and Total Errors, with higher scores indicating greater impairment.|3 months following Baseline assessment|||Incorrect Responses||Standard Deviation|Mean
686193|NCT01492439|Secondary|The Wisconsin Card Sorting Task at 6 Months|The WCST is a commonly used test of executive functioning that measures cognitive flexibility and problem solving skills. The 'number of categories' measures the number of correct responses. The percentage of perseverative errors provides the concentration of perseverative errors in relation to overall test performance. The percentage conceptual level response provides the percentage of consecutive correct responses in runs of 3 or more.|6 months following baseline assessment|||Correct responses||Standard Deviation|Mean
686194|NCT01492439|Secondary|The Wisconsin Card Sorting Task at 6 Months|The WCST is a commonly used test of executive functioning that measures cognitive flexibility and problem solving skills. The 'number of categories' measures the number of correct responses. The percentage of perseverative errors provides the concentration of perseverative errors in relation to the overall test performance. The percentage conceptual level response provides the percentage of consecutive correct responses in runs of 3 or more.|6 months following Baseline assessment|||Percentage of responses||Standard Deviation|Mean
686195|NCT01492439|Secondary|The Wisconsin Card Sorting Test at 3 Months|The Wcst is a commonly used test of executive functioning that measures cognitive flexibility and problem solving skills. The 'number of categories' measures the number of correct responses. The percentage of perseverative errors provides the concentration of perseverative errors in relation to overall test performance. The percentage conceptual level response provides the percentage of consecutive correct responses in runs of 3 or more.|3 months following Baseline assessment|||Correct responses||Standard Deviation|Mean
686196|NCT01492439|Secondary|The Wisconsin Card Sorting Test at 3 Months|The WCST is a commonly used test of executive functioning that measures cognitive flexibility and problem solving skills. The 'number of categories' measures the number of correct responses. The percentage of perseverative errors provides the concentration of perseverative errors in relation to the overall test performance. The percentage conceptual level response provides the percentage of consecutive correct responses in runs of 3 or more.|3 months following Baseline assessment|||Percentage of responses||Standard Deviation|Mean
686197|NCT01492439|Secondary|The Trail Making Part B at 6 Months|The Trail Making Test Part B assesses executive function. Trail Making Part B is similar to Part A but is a more challenging task because it requires subjects to connect consecutively numbered and lettered circles by alternating between the 2 sequences. For this timed test, participants are scored by the number of seconds taken to complete the task, with high scores revealing greater impairment.|6 months following Baseline assessment|||Seconds||Standard Deviation|Mean
686198|NCT01492439|Secondary|The Trail Making Test Part B at 3 Months|The Trail Making Test Part B assesses executive function. Trail Making Part B is similar to Part A but is a more challenging task because it requires subjects to connect consecutively numbered and lettered circles by alternating between the 2 sequences. For this timed test, participants are scored by the number of seconds taken to complete the task, with high scores revealing greater impairment.|3 months following Baseline assessment|||Seconds||Standard Deviation|Mean
686199|NCT01492439|Secondary|The Digit Span Subtest of the Wechsler Adult Intelligence Scale - III at 6 Months|Short term memory will be evaluated with the digit span subtest of the Wechsler Adult Intelligence Scale-III. Participants are asked to recall a sequence of numbers, starting with 2 and increasing to a sequence of 9 numbers. If the participant repeats the sequence correctly they score a one, if incorrect then score a zero. There are two lists, one to be repeated forwards and the other backwards. The total score is a sum of sequences recalled correctly.|6 months following Baseline assessment|||Correct responses||Standard Deviation|Mean
686200|NCT01492439|Secondary|The Digit Span Subtest of the Wechsler Adult Intelligence Scale - III at 3 Months|Short term memory will be evaluated with the digit span subtest of the Wechsler Adult Intelligence Scale-III. Participants are asked to recall a sequence of numbers, starting with 2 and increasing to a sequence of 9 numbers. If the participant repeats the sequence correctly they score a one, if incorrect then score a zero. There are two lists, one to be repeated forwards and the other backwards. The total score is a sum of sequences recalled correctly.|3 months following Baseline assessment|||Correct responses||Standard Deviation|Mean
686201|NCT01492439|Secondary|The Trail Making Test Part A at 6 Months|The Trail Making Test Part A is a test involving using lines to connect numbers, it will be used to assess scanning ability and psychomotor speed. For this timed test, participants are scored by the number of seconds taken to complete the task, with high scores revealing greater impairment.|6 months following Baseline assessment|||Seconds||Standard Deviation|Mean
686202|NCT01492439|Secondary|The Trail Making Test Part A at 3 Months|The Trail Making Test Part A is a test involving using lines to connect numbers, it will be used to assess scanning ability and psychomotor speed. For this timed test, participants are scored by the number of seconds taken to complete the task, with high scores revealing greater impairment.|3 months following Baseline assessment|||Seconds||Standard Deviation|Mean
686203|NCT01492439|Secondary|The California Verbal Learning Test at 6 Months|Verbal learning and memory will be assessed with the California Verbal Learning Test. A 9 word list is read to the participant (List A). Participants are asked to immediately free recall List A over 4 trials, then recall after a distractor task (short delay), then after a long delay.In the cued recall section, participants are asked to recall by category. In the long delay yes/no recognition, participants are asked to recall List A items out of a 27 word list. Higher repetitions and intrusions reveal greater impairment.|6 months following Baseline assessment|||Correct responses||Standard Deviation|Mean
686204|NCT01492439|Secondary|The California Verbal Learning Test at 3 Months|Verbal learning and memory will be assessed with the California Verbal Learning Test. A 9 word list is read to the participant (List A). Participants are asked to immediately free recall List A over 4 trials, then recall after a distractor task (short delay), then after a long delay.In the cued recall section, participants are asked to recall by category. In the long delay yes/no recognition, participants are asked to recall List A items out of a 27 word list. Higher repetitions and intrusions reveal greater impairment.|3 months following Baseline Assessment|||Correct responses||Standard Deviation|Mean
686205|NCT01492439|Secondary|The Rosenberg Self-Esteem Scale Score at 6 Months|The Rosenberg Self Esteem Scale measures self esteem. This is a ten item, four point Likert scale with scores ranging from strongly agree to strongly disagree. Scores can range from 0-30. Total sum scores between 15 and 25 are within normal range; with scores below 15 suggest low self-esteem.|6 months following Baseline assessment|||units on a scale||Standard Deviation|Mean
686206|NCT01492439|Secondary|The Positive and Negative Symptoms Scale (PANSS) Score at 6 Months|Symptoms of psychosis will be assessed using the Positive and Negative Syndrome Scale. The 30 item scale is comprised of 3 subscales measuring positive, negative and general psychopathology symptoms. Each item is scored using 7 anchoring criteria; 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores for the positive scale range from 7-49, the negative scale from 7-49, and general psychopathology 16-112, with total summed scores ranging from 30-210. 95>high, 75-95 medium and <75 low symptomology.|6 months following Baseline assessment|||units on a scale||Standard Deviation|Mean
686207|NCT01492439|Secondary|The Rosenberg Self-Esteem Scale Score at 3 Months|The Rosenberg Self Esteem Scale measures self esteem. This is a ten item, four point Likert scale with scores ranging from strongly agree to strongly disagree. Scores can range from 0-30. Total sum scores between 15 and 25 are within normal range; with scores below 15 suggest low self-esteem.|3 months following Baseline|||units on a scale||Standard Deviation|Mean
686208|NCT01492439|Secondary|Positive and Negative Symptoms Scale (PANSS) Score at 3 Months|Symptoms of psychosis will be assessed using the Positive and Negative Syndrome Scale. The 30 item scale is comprised of 3 subscales measuring positive, negative and general psychopathology symptoms. Each item is scored using 7 anchoring criteria; 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores for the positive scale range from 7-49, the negative scale from 7-49, and general psychopathology 16-112, with total summed scores ranging from 30-210. 95>high, 75-95 medium and <75 low symptomology.|3 months following baseline|||units on a scale||Standard Deviation|Mean
686209|NCT01492439|Primary|Completion of Academic Semesters|During the study period, course instructors provided information as to whether participants had completed or withdrawn from academic semester 1 and 2. This data was used to determine whether completion of academic semesters might be explained by attending cognitive remediation alongside supported education. At the end of the each semester, course instructors notified the research team as to whether participants had completed or not completed the academic semester. The unit of measure, 'course completed' refers to the completion of the required number of courses in that academic semester to progress through to the next semester.|The end of the semester 1 (3 months following baseline) and semester 2 (6 months following baseline)|||Courses completed||Standard Deviation|Mean
686210|NCT01492426|Secondary|Percentage of Genotype 1a Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)|SVR12 was defined as hepatitis C virus RNA levels lower than the lower limit of quantitation, ie, 25 IU/mL target detected or target not detected at follow-up week 12 of treatment.|Week 12 (Follow-up period)|The analysis was performed in all treated participants who received at least 1 dose of active study therapy. Here, 'Number of participants analysed' signifies Genotype 1a participants assessed for SVR12 response.||Percentage of participants||95% Confidence Interval|Number
686211|NCT01492426|Secondary|Percentage of Genotype 1b Participants With Sustained Virologic Response at Follow-up Week 24 (SVR24)|SVR24 was defined as hepatitis C virus RNA levels lower than the lower limit of quantitation, ie, 25 IU/mL target detected or target not detected at follow-up week 24 of treatment.|Week 24 (Follow-up period)|The analysis was performed in all treated participants who received at least 1 dose of active study therapy. Here, 'Number of participants analysed' signifies Genotype 1b participants assessed for SVR24 response.||Percentage of participants||95% Confidence Interval|Number
686212|NCT01492426|Secondary|Percentage of Genotype 1b Participants With Complete Early Virologic Response (cEVR)|cEVR was defined as hepatitis C virus RNA levels lower than the lower limit of quantitation, ie, 25 IU/mL target not detected at Week 12 of treatment.|Week 12|The analysis was performed in all treated participants who received at least 1 dose of active study therapy. Here, 'Number of participants analysed' signifies Genotype 1b participants assessed for cEVR response.||percentage of participants||95% Confidence Interval|Number
686213|NCT01492426|Secondary|Percentage of Genotype 1b Participants With Extended Rapid Virologic Response (eRVR) at Both Week 4 and Week 12|eRVR was defined as hepatitis C virus RNA levels lower than the lower limit of quantitation, ie, 25 IU/mL target not detected at both Weeks 4 and 12 of treatment.|Week 4, Week 12|The analysis was performed in all treated participants who received at least 1 dose of active study therapy. Here, 'Number of participants analysed' signifies Genotype 1b participants assessed for eRVR response.||Percentage of participants||95% Confidence Interval|Number
686214|NCT01492426|Secondary|Percentage of Genotype 1b Participants With Rapid Virologic Response (RVR) at Week 4|RVR was defined as hepatitis c virus RNA levels lower than lower limit of quantitation, ie, 25 IU/mL target not detected at Week 4 of treatment.|Week 4|The analysis was performed in all treated participants who received at least 1 dose of active study therapy. Here, 'Number of participants analysed' signifies Genotype 1b participants assessed for RVR response.||Percentage of participants||95% Confidence Interval|Number
686215|NCT01492426|Primary|Percentage of Genotype 1b Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)|SVR12 was defined as hepatitis C virus RNA levels to be lower than the limit of quantitation, ie, 25 IU/mL target detected or target not detected at follow-up Week 12.|Week 12 (Follow-up period)|The analysis was performed in all treated participants who received at least 1 dose of active study therapy. Here, 'Number of participants analysed' signifies Genotype 1b participants assessed for SVR12 response.||Percentage of participants||95% Confidence Interval|Number
686216|NCT01492400|Secondary|Change From Baseline in Total Area of Macular Leakage in the Study Eye Measured on Fluorescein Angiography (FA)|FA is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. Photographs are taken with a specialized low-power microscope with an attached camera designed to photograph the interior of the eye, including the retina and optic disc. A negative change from baseline indicates a decrease in leakage (improvement) and a positive change from baseline indicates an increase in leakage (worsening).|Baseline, Month 12|Intent-to-Treat: all randomized patients||Square Millimeters (mm^2)||Standard Deviation|Mean
686217|NCT01492400|Secondary|Change From Baseline in Foveal Thickness Measured by Optical Coherence Tomography (OCT) in the Study Eye|OCT is a laser based non-invasive diagnostic system providing high-resolution imaging sections of the fovea (part of the retina) in the study eye after pupil dilation. A negative change from baseline indicates an improvement (less foveal thickness) and a positive change from baseline indicates a worsening (more foveal thickness).|Baseline, Month 12|Intent-to-Treat: all randomized patients||Microns||Standard Deviation|Mean
686218|NCT01492400|Primary|Average Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The average BCVA is calculated across study visits for each patient. A positive number change from baseline indicates an improvement and a negative number change from baseline indicates a worsening.|Baseline, 12 Months|Intent-to-Treat: all randomized patients||Letters||Standard Deviation|Mean
686219|NCT01492088|Secondary|Monomethyl Auristatin E (MMAE) Plasma Concentrations (Phase 1 and 2)|Blood samples were collected and tested for MMAE plasma concentrations.|Cycle 1 and 8 pre-dose and 5 minutes, 24, 48, 96 and 312 hours post-dose; Cycle 2 pre-dose, 5 minutes and 24, 48 and 96 hours post-dose; Cycle 3 to 16 pre-dose and 5 minutes post-dose|"PK-evaluable population was defined as participants with sufficient dosing and PK data to reliably estimate PK parameters. Cycle 2 Day 2 values are collected in phase 1 participants only. n = number of participants analyzed at that given time-point. Data was summarized together for all participants in brentuximab vedotin 1.8 mg/kg arm group."||ng/mL||Standard Deviation|Mean
686220|NCT01492088|Secondary|Serum Concentration of Total Antibodies (Conjugated and Unconjugated)|Blood samples were collected and tested for conjugated and unconjugated antibodies.|Cycle 1 and 8 pre-dose and 5 minutes, 24, 48, 96 and 312 hours post-dose; Cycle 2 pre-dose, 5 minutes and 24, 48 and 96 hours post-dose; Cycle 3 to 16 pre-dose and 5 minutes post-dose|"PK-evaluable population was defined as participants with sufficient dosing and PK data to reliably estimate PK parameters. Cycle 2 Day 2 values are collected in phase 1 participants only. n = number of participants analyzed at that given time-point. Data was summarized together for all participants in brentuximab vedotin 1.8 mg/kg arm group."||ug/mL||Standard Deviation|Mean
686221|NCT01492088|Secondary|Antibody-drug Conjugate (ADC) Serum Concentrations (Phase 1 and 2)|Blood samples were collected and tested for serum concentrations of brentuximab vedotin antibody-drug conjugate.|Cycle 1 and 8 pre-dose and 5 minutes, 24, 48, 96 and 312 hours post-dose; Cycle 2 pre-dose, 5 minutes and 24, 48 and 96 hours post-dose; Cycle 3 to 16 pre-dose and 5 minutes post-dose|"PK-evaluable population was defined as participants with sufficient dosing and PK data to reliably estimate PK parameters. Cycle 2 Day 2 values are collected in phase 1 participants only. n = number of participants analyzed at that given time-point. Data was summarized together for all participants in brentuximab vedotin 1.8 mg/kg arm group."||ug/mL||Standard Deviation|Mean
686222|NCT01492088|Secondary|Number of Participants With Clinically Significant Vital Signs Reported as AEs (Phase 1 and 2)|Vital signs measurements included supine (after 3-5 minutes in this position) and standing (after 3-5 minutes in this position) measurements of diastolic and systolic blood pressure, heart rate, and oral temperature.|From the first dose through 30 days after the last dose of study medication (Up to 15 months)|Safety population is defined as all participants who received at least 1 dose of study drug. Data was summarized together for Phase 1 and 2 participants in brentuximab 1.8 mg/kg arm group.||participants|||Number
686223|NCT01492088|Secondary|Number of Participants With Abnormal Clinical Laboratory Values Reported as AEs (Phase 1 and 2)|Abnormal clinical laboratory values (serum chemistry and hematology) were reported as AEs if they were considered by the investigator to be a clinically significant change from Baseline or led to premature discontinuation of study treatment, dose modification, or other therapeutic intervention.|From the first dose through 30 days after the last dose of study medication (Up to 15 months)|Safety population is defined as all participants who received at least 1 dose of study drug. Data was summarized together for Phase 1 and 2 participants in brentuximab 1.8 mg/kg arm group.||participants|||Number
686224|NCT01492088|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (Phase 1 and 2)|An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A SAE is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. AE severity was graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.|From the first dose through 30 days after the last dose of study medication (up to 15 months)|Safety population is defined as all participants who received at least 1 dose of study drug. Data was summarized together for Phase 1 and 2 participants in brentuximab 1.8 mg/kg arm group.||participants|||Number
686691|NCT01486927|Secondary|Annualized Bleeding Rate for Total Bleeds and Traumatic Bleeds|The annualized bleeding rate was derived for each subject as follows: 365.25*(number of bleeding episodes requiring treatment) / (observed treatment period of interest).|Up to 24 months|||Number of bleeds per year||Inter-Quartile Range|Median
686225|NCT01492088|Secondary|Overall Survival (OS) (Phase 1 and 2)|OS is the time in months from start of study treatment to date of death due to any cause.|Every 6 months after EOT, until the sooner of death, study closure, or 2 years after enrollment of the last participant (Up to 60 months)|Safety population is defined as all participants who received at least 1 dose of study drug.||months||95% Confidence Interval|Median
686226|NCT01492088|Secondary|Progression Free Survival (PFS) (Phase 1 and 2)|PFS is defined as time in months from start of study treatment to first documentation of objective tumor progression per IRF assessment or up to death due to any cause, whichever occurs first. and PD is defined as any new lesion or increase by >50% of previously involved sites from nadir.|Cycles 2, 4, 7, 10, 13 and 16 (21-day cycles) until disease progression, death or EOT and then every 12 weeks for 12 months after EOT, until disease progression, or death (Up to 27 months)|Safety population is defined as all participants who received at least 1 dose of study drug. PFS was censored on the day following the date of last radiological assessment of measured lesions documenting absence of PD for participants who did not have tumor progression.||months||95% Confidence Interval|Median
686227|NCT01492088|Secondary|Event Free Survival (EFS) (Phase 1 and 2)|EFS is defined as the time IN MONTHS from first dose until any cause of treatment failure: disease progression, premature discontinuation of treatment for any reason, or death due to any cause, whichever occurs first. PD is defined as any new lesion or increase by >50% of previously involved sites from nadir.|Cycles 2, 4, 7, 10, 13 and 16 (21-day cycles) until disease progression, death or EOT and then every 12 weeks for 12 months after EOT, until disease progression, or death (Up to 27 months)|Safety population is defined as all participants who received at least 1 dose of study drug. EFS was censored on the last follow-up date if none of the above events occur during the study.||months||95% Confidence Interval|Median
686228|NCT01492088|Secondary|Duration of Response (DOR) (Phase 1 and 2)|DOR is defined as the time in months from the date of first documentation of a CR or PR to the date of first documentation of tumor progression or PD per IRF assessment according to IWG criteria or to death due to any cause, whichever comes first. CR is defined as the disappearance of all evidence of disease and PD is defined as any new lesion or increase by >50% of previously involved sites from nadir.|Cycles 2, 4, 7, 10, 13 and 16 (21-day cycles) until disease progression, death or EOT and then every 12 weeks for 12 months after EOT, until disease progression, or death (Up to 27 months)|Participants with response from the Safety Population, all enrolled participants who received at least one dose of brentuximab vedotin, with data available for analysis. Duration of response was censored at last observation documenting absence of PD for participants who did not have tumor progression.||months||95% Confidence Interval|Median
686229|NCT01492088|Secondary|Time to Response (Phase 1 and 2)|Time to response is defined as the time in months from the first dose of study treatment until the date of the first assessment of confirmed CR or PR. as assessed by an IRF using IWG revised response criteria for malignant lymphoma. CR is defined as the disappearance of all evidence of disease and PR is defined as regression of measurable disease and no new sites.|Cycles 2, 4, 7, 10, 13 and 16 (21-day cycles) until disease progression, death or EOT (Up to 15 months)|Response-evaluable population included participants who received at least 1 dose of study drug, have measurable disease at baseline, and 1 postbaseline disease assessment. Time to response was censored on the last radiological assessment of measured lesions documenting absence of CR or PR for participants who did not have CR or PR.||months||95% Confidence Interval|Median
686230|NCT01492088|Secondary|Time to Progression (TTP) (Phase 1 and 2)|TTP is defined as the time in months from first dose until the first subsequent documentation of objective tumor progression. Progressive disease (PD) is defined as any new lesion or increase by ≥50% of previously involved sites from nadir.|Cycles 2, 4, 7, 10, 13 and 16 (21-day cycles) until disease progression, death or EOT and then every 12 weeks for 12 months after EOT, until disease progression, or death (Up to 27 months)|Safety population is defined as all participants who received at least 1 dose of study drug. TTP was censored on last radiological assessment of measured lesions documenting absence of PD for participants who did not have tumor progression.||months||95% Confidence Interval|Median
686231|NCT01492088|Secondary|Overall Response Rate (ORR) (Phase 1)|Overall response rate is defined as the percentage of participants with CR or PR as assessed by an IRF using IWG Revised Response Criteria for Malignant Lymphoma. CR is defined as the disappearance of all evidence of disease and PR is defined as regression of measurable disease and no new sites.|Cycles 2, 4, 7, 10, 13 and 16 (21-day cycles) until disease progression, death or EOT (Up to 15 months)|Response-evaluable population included participants who received at least 1 dose of study drug, have measurable disease at baseline, and 1 postbaseline disease assessment. Participants enrolled in Phase 1 of the study were evaluated for this outcome measure.||percentage of participants||95% Confidence Interval|Number
686232|NCT01492088|Secondary|Number of Participants With Antitherapeutic Antibodies (ATA) and Neutralizing ATA (nATA) (Phase 1 and 2)|Blood samples were collected to assess the immunogenicity of brentuximab vedotin (ATA and nATA development) using a laboratory test. ATA-positive samples were further characterized as transiently ATA positive (defined as 1 or 2 post-Baseline ATA-positive responses), persistently ATA positive (defined as more than 2 post-Baseline ATA positive responses), and nATA positive or negative.|Baseline up to EOT (Up to 15 months)|Participants from the Safety Population, all enrolled participants who received at least one dose of brentuximab vedotin, with data available for analysis.||participants|||Number
686233|NCT01492088|Primary|Overall Response Rate (ORR) (Phase 1 and 2)|Overall response rate is defined as the percentage of participants with complete remission (CR) or partial remission (PR) as assessed by an independent review facility (IRF) using International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma. CR is defined as the disappearance of all evidence of disease and PR is defined as regression of measurable disease and no new sites.|Cycles 2, 4, 7, 10, 13 and 16 (21-day cycles) until disease progression, death or end of treatment (EOT) (Up to 15 months)|Response-evaluable population included participants who received at least 1 dose of study drug, have measurable disease at baseline, and 1 postbaseline disease assessment. Data was summarized together for Phase 1 and 2 participants in brentuximab 1.8 mg/kg arm group.||percentage of participants||95% Confidence Interval|Number
686350|NCT01490866|Secondary|Frequency of Adverse Events as a Measure of Safety|The frequency of adverse events (AEs) was analyzed in 2 groups of patients, those receiving FOLFOX/bevacizumab (N=70), and patients who received axitinib maintenance (N = 48). AEs were assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0.|Every 4 weeks plus 30 days during treatment and up to 5 years thereafter.|||participants|||Number
686234|NCT01492088|Primary|Monomethyl Auristatin E (MMAE) Plasma Concentrations (Phase 1)|Blood samples were collected and tested for MMAE plasma concentrations.|Cycle 1 and 8 pre-dose and 5 minutes, 24, 48, 96 and 312 hours post-dose; Cycle 2 pre-dose, 5 minutes and 24, 48 and 96 hours post-dose; Cycle 3 to 16 pre-dose and 5 minutes post-dose|Data for this outcome measure was not summarized for Phase 1 participants only, data was summarized together for Phase 1 and 2 participants in brentuximab 1.4 mg/kg and 1.8 mg/kg arms groups. Data has been presented in OM 21.|||||
686235|NCT01492088|Primary|Serum Concentration of Total Antibodies (Conjugated and Unconjugated) (Phase 1)|Blood samples were collected and tested for conjugated and unconjugated antibodies.|Cycle 1 and 8 pre-dose and 5 minutes, 24, 48, 96 and 312 hours post-dose; Cycle 2 pre-dose, 5 minutes and 24, 48 and 96 hours post-dose; Cycle 3 to 16 pre-dose and 5 minutes post-dose|Data for this outcome measure was not summarized for Phase 1 participants only, data was summarized together for Phase 1 and 2 participants in brentuximab 1.4 mg/kg and 1.8 mg/kg arms groups. Data has been presented in OM 20.|||||
686236|NCT01492088|Primary|Antibody-drug Conjugate (ADC) Serum Concentrations (Phase 1)|Blood samples were collected and tested for serum concentrations of brentuximab vedotin antibody-drug conjugate.|Cycle 1 and 8 pre-dose and 5 minutes, 24, 48, 96 and 312 hours post-dose; Cycle 2 pre-dose, 5 minutes and 24, 48 and 96 hours post-dose; Cycle 3 to 16 pre-dose and 5 minutes post-dose|Data for this outcome measure was not summarized for Phase 1 participants only, data was summarized together for Phase 1 and 2 participants in brentuximab 1.4 mg/kg and 1.8 mg/kg arms groups. Data has been presented in OM 19.|||||
686237|NCT01492088|Primary|Number of Participants With Clinically Significant Vital Signs Values Reported as AEs (Phase 1)|Vital signs measurements included supine (after 3-5 minutes in this position) and standing (after 3-5 minutes in this position) measurements of diastolic and systolic blood pressure, heart rate, and oral temperature.|From the first dose through 30 days after the last dose of study medication (Up to 15 months)|Safety population is defined as all participants who received at least 1 dose of study drug. Participants enrolled in Phase 1 of study were evaluated for this outcome measure.||participants|||Number
686238|NCT01492088|Primary|Number of Participants With Abnormal Clinical Laboratory Values Reported as AEs (Phase 1)|Abnormal clinical laboratory values (serum chemistry and hematology) were reported as AEs if they were considered by the investigator to be a clinically significant change from Baseline or led to premature discontinuation of study treatment, dose modification, or other therapeutic intervention.|From the first dose through 30 days after the last dose of study medication (Up to 15 months)|Safety population is defined as all participants who received at least 1 dose of study drug. Participants enrolled in Phase 1 of study were evaluated for this outcome measure.||participants|||Number
686239|NCT01492088|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (Phase 1)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A Serious Adverse Event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. AE severity was graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.|From the first dose through 30 days after the last dose of study medication (Up to 15 months)|Safety population is defined as all participants who received at least 1 dose of study drug. Participants enrolled in Phase 1 of study were evaluated for this outcome measure.||participants|||Number
686240|NCT01491984|Secondary|Time to Successful Intubation|Time to successful intubation was documented during the second laryngoscopy and defined as the time from the insertion of the Macintosh laryngoscope into the oral cavity to its removal.|intraoperative||||||
686241|NCT01491984|Secondary|Operator Rating of Difficulty|The attending anesthesiologist rated the difficulty in using each technique to intubate the larynx using an 11-point numeric rating scale and a 4-point visual rating scale.|intraoperative||||||
686242|NCT01491984|Secondary|Number of Intubation Attempts|Number of intubation attempts was recorded after intubation was completed.|intraoperative||||||
686243|NCT01491984|Primary|Cormack-Lehane Grade|"The anesthesiologist graded the laryngeal view after induction of anesthesia using Cormack-Lehane Scale.
Grade 1 = full view of glottis Grade 2a = partial view of glottis Grade 2b = Only posterior extremity of glottis seen or only arytenoid cartilages Grade 3 = Only epiglottis seen, none of glottis seen Grade 4 = Neither glottis nor epiglottis seen"|intraoperative|||participants|||Number
686244|NCT01491919|Secondary|Change in Diastolic Blood Pressure From Baseline in Lisinopril SOC Group|Lisinopril SOC participants were not given the ambulatory blood pressure machine to obtain readings at home, as was the Lisinopril-naive participants. Instead BP measurements were obtained during screening visit and compared to the Day 14 to 40 visit measurements (note: the participants were not required to attend a Day 14 (+/-3 day visit) but did need to attend sometime between Day 14 to Day 40. The mean from the blood pressure measurements was calculated.|Screening to Day 14 to 40|Change in diastolic blood pressure from baseline is reported here for lisinopril SOCparticipants (not the Lisinopril-naive group which are reported separately).||mmHg||Standard Deviation|Mean
686245|NCT01491919|Secondary|Change in Systolic Blood Pressure (BP) From Baseline in Lisinopril SOC Group|Lisinopril SOC participants were not given the ambulatory blood pressure machine to obtain readings at home, as was the Lisinopril-naive participants. Instead BP measurements were obtained during screening visit and compared to the Day 14 to 40 visit measurements. Note: these participants were not required to attend a Day 14 (+/-3 day visit) but did need to attend sometime between Day 14 to Day 40 (inclusive). The mean of these blood pressure measurements was calculated.|Screening to Day 14 to 40|Change in systolic blood pressure from baseline is reported here for lisinopril SOCparticipants (not the Lisinopril-naive group which are reported separately).||mmHg||Standard Deviation|Mean
686261|NCT01491802|Secondary|Diaphragm Electromyogram (EMGdi) at Isotime Exercise|EMGdi was measured during constant work rate exercise tests via a multipair-electrode esophageal catheter. EMGdi expressed as a percentage of its maximum is used as an index of inspiratory neural drive. Isotime was defined as the highest exercise time in minutes common to both post-treatment tests.|4 weeks|Although 14 subjects completed both treatment arms, only 9 subjects had complete measurements of EMGdi and respiratory pressures.||percentage of maximum EMGdi||Standard Deviation|Mean
686246|NCT01491919|Secondary|Change in Systolic Blood Pressure From Baseline in Lisinopril-naive Participants|"Ambulatory blood pressure readings were measured during the baseline/pre-study dose period using a SpaceLabs (Redmond, WA) device at home to avoid the confounding effects of venipuncture and abnormal sleep pattern.
Another blood pressure reading was performed at 1 day before the final dose of lisinopril (day before the last scheduled visit).
The mean from these measurements was calculated."|Baseline to Day 14 (+/- 3 days)|Change in systolic blood pressure from baseline is reported here for lisinopril-naive participants (not the standard of care (SOC) group which are reported separately).||mmHg||Standard Deviation|Mean
686247|NCT01491919|Secondary|Change in Diastolic Blood Pressure From Baseline in Lisinopril-naive Participants|"Ambulatory blood pressure readings were measured during the baseline/pre-study dose period using a SpaceLabs (Redmond, WA) device at home to avoid the confounding effects of venipuncture and abnormal sleep pattern.
Another blood pressure reading was performed at 1 day before the final dose of lisinopril (day before the last scheduled visit).
The mean of these measurements was calculated."|Baseline to Day 14 (+/-3 days)|Change in diastolic blood pressure from baseline is reported here for lisinopril-naive participants (not the standard of care group which are reported separately).||mmHg||Standard Deviation|Mean
686248|NCT01491919|Secondary|Change in Urine Protein/Creatinine From Baseline in Lisinopril-naive Participants.|Change in urine protein/creatinine obtained as follows: Mean change (worst post-dose from baseline) presented for urine protein/creatinine ratio. Geometric mean of the ratio (worst post-dose / baseline with Geometric Coefficient of Variation percent (CV%) and greatest decrease presented for eGFR by dose group. Two patients in the high dose group had an evaluable urine protein/creatinine change.|Baseline to worst post-dose before Day 14 (+/- 3 days)|||mg/mg||Geometric Coefficient of Variation|Geometric Mean
686249|NCT01491919|Secondary|Largest eGFR Percent Decrease From Baseline in Lisinopril-naive Participants|"The eGFR at entry will need to be ≥ 30 ml/min/1.73m^2 to minimize concerns about an acute angiotensin-converting enzyme inhibitor (ACEI) mediated reduction in kidney function.
Largest eGFR percent decrease from baseline reported in results section."|Baseline to Day 14 (+/- 3 days)|||percentage|||Number
686250|NCT01491919|Primary|Number of Adverse Events (AEs) and Serious Adverse Events (SAEs) During/After Study Drug Administration|Number of Adverse Events (AEs) related and not related to study drug; number of Serious Adverse Events (SAEs) related and not related to study drug|First dose of study drug to 30 days after final study visit for AEs and until resolution for SAEs|||events|||Number
686251|NCT01491919|Primary|PK Renal Clearance (CLrenal)|At the Day 14 (±3 days) visit, blood (1 mL) will be collected at 0 hour (pre-dose) and at 1, 2, 4, 5, 8, 12 and 24 hours post-lisinopril dose for determination of CLrenal. Geometric mean was calculated from all measurements.|Day 14 (+/- 3 d) of dose at 0 hour and 1, 2, 4, 5, 8, 12, and 24 hrs after dose.|||L/h/70 kg||Geometric Coefficient of Variation|Geometric Mean
686252|NCT01491919|Primary|PK - Oral Clearance (CL/F)|At the Day 14 (±3 days) visit, blood (1 mL) will be collected at 0 hour (pre-dose) and at 1, 2, 4, 5, 8, 12 and 24 hours post-lisinopril dose for determination of CL/F. Geometric mean was calculated from all measurements.|Day 14 (+/- 3 d) of dose at 0 hour and at 1, 2, 4, 5, 8, 12, and 24 hrs after dose|||L/h/70 kg||Geometric Coefficient of Variation|Geometric Mean
686253|NCT01491919|Primary|PK - Time of the Maximum Observed Concentration in Plasma (Tmax)|At the Day 14 (±3 days) visit, blood (1 mL) will be collected at 0 hour (pre-dose) and at 1, 2, 4, 5, 8, 12 and 24 hours post-lisinopril dose for determination of plasma lisinopril concentration. Medium was calculated from all measurements.|Day 14 (+/- 3 d) of dose at 0 hour and 1, 2, 4, 5, 8, 12, and 24 hrs after dose|||hours||Full Range|Median
686254|NCT01491919|Secondary|Worse Post-dose Decrease in Estimated Glomerular Filtration Rate (eGFR) From Baseline in Lisinopril-naive Participants|The eGFR at entry will need to be ≥ 30 ml/min/1.73m^2 to minimize concerns about an acute angiotensin-converting enzyme inhibitors (ACE-I)-mediated reduction in kidney function. eGFR ratio was computed from the worst post-dose value divided by the Baseline value.|Baseline to Day 14 (+/- 3 days)|||ratio||Geometric Coefficient of Variation|Geometric Mean
686255|NCT01491919|Secondary|Change in Potassium Level From Baseline in Lisinopril-naive Participants|Potassium values will be obtained at Baseline and Day 14 prior to the final dose of study drug. Mean calculated from the two measurements.|At baseline visit and Day 14 prior to final study dose.|||mEq/L||Standard Deviation|Mean
686256|NCT01491919|Primary|PK - Maximum Observed Concentration of Drug in Plasma (Cmax)|At the Day 14 (±3 days) visit, blood (1 mL) will be collected at 0 hour (pre-dose) and at 1, 2, 4, 5, 8, 12 and 24 hours post-lisinopril dose for determination of Cmax. Geometric mean was calculated from all measurements.|Day14 (+/- 3 d) of dose at 0 hour and 1, 2, 4, 5, 8, 12, and 24 hrs after dose|||ng/ml||Geometric Coefficient of Variation|Geometric Mean
686257|NCT01491919|Primary|Pharmacokinetics (PK) - Area Under the Plasma Concentration-time Curve (AUC)|At the Day 14 (±3 days) visit, blood (1 mL) will be collected at 0 hour (pre-dose) and at 1, 2, 4, 5, 8, 12 and 24 hours post-lisinopril dose for determination of AUC. Geometric mean was calculated from all measurements.|Day 14 (+/- 3 days) of lisinopril therapy at hours 0 (pre-dose) and 1,2,4,5,8,12 and 24 hrs after dose|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
686258|NCT01491802|Secondary|Forced Expiratory Volume in 1 Second (FEV1)|Measurements of pulmonary function included spirometry and body plethysmography. Values reported are 90 minutes post-dose after 4 weeks of treatment.|4 weeks|14 subjects completed both treatments for comparison.||L||Standard Deviation|Mean
686259|NCT01491802|Secondary|Mean Expiratory Flow at Isotime Exercise|Mean expiratory flow was measured during constant work rate exercise tests. Isotime was defined as the highest exercise time in minutes common to both post-treatment tests.|4 weeks|14 subjects completed both treatment arms for comparison.||L/s||Standard Deviation|Mean
686260|NCT01491802|Secondary|Tidal Esophageal Pressure (Pes) Swings at Isotime Exercise|Tidal esophageal pressure (Pes) swings were measured via an esophageal balloon catheter during constant work rate exercise tests. Tidal Pes expressed relative to maximum is an index of respiratory effort. Isotime was defined as the highest exercise time in minutes common to both post-treatment tests.|4 weeks|Although 14 subjects completed both treatment arms for comparison, only 9 subjects also had complete measurements of EMGdi and respiratory pressures.||percentage of maximum Pes||Standard Deviation|Mean
686262|NCT01491802|Secondary|Inspiratory Capacity at Isotime Exercise|Measurements of inspiratory capacity (IC) were conducted during constant work rate exercise tests. Isotime was defined as the highest time in minutes completed in both post-treatment tests.|4 weeks|14 subjects completed both treatment arms for comparison.||L||Standard Deviation|Mean
686263|NCT01491802|Secondary|"Intensity of Unpleasantness of Breathing at Isotime Exercise"|"Intensity rating (modified 10-point Borg scale) measured at a standardized time (isotime) during constant work rate exercise tests. A rating of 0 represents no unpleasantness of breathing up to a maximum of 10. An improvement would be noted as a decrease in the Borg scale rating. Isotime was defined as the highest exercise time in minutes common to both post-treatment tests."|4 weeks|Of the 17 randomized subjects, 3 subjects were withdrawn (2 AEs, 1 withdrawn consent ) leaving 14 completed subjects for analysis.||units on a scale||Standard Deviation|Mean
686264|NCT01491802|Secondary|Ventilation at Isotime Exercise|Ventilation was measured during constant work rate exercise tests. Isotime was defined as the highest exercise time in minutes common to both post-treatment tests.|4 weeks|14 subjects completed both treatment arms for comparison.||L/min||Standard Deviation|Mean
686265|NCT01491802|Secondary|Inspiratory Capacity at Rest|Measurements of pulmonary function included spirometry and body plethysmography. The resting inspiratory capacity (IC) values reported here are 90 minutes post-dose after 4 weeks of treatment.|4 weeks|14 subjects completed both treatments for comparison.||L||Standard Deviation|Mean
686266|NCT01491802|Secondary|Exercise Endurance Time|Duration of constant work rate cycle exercise at 75% of maximum|4 weeks|||minutes||Standard Deviation|Mean
686267|NCT01491802|Primary|Exertional Dyspnea Intensity at Isotime Exercise.|Intensity of dyspnea (defined as breathing discomfort) at a standardized time (isotime) during constant work rate exercise tests as measured by the modified 10-point Borg scale. A rating of 0 represents no dyspnea up to a maximum of 10: a smaller rating is therefore an improvement. Isotime was defined as the highest exercise time in minutes completed in both post-treatment tests.|4 weeks|Of the 17 randomized subjects, 3 subjects were withdrawn (2 AEs, 1 withdrawn consent ) leaving 14 completed subjects for analysis.||units on a scale||Standard Deviation|Mean
686268|NCT01491737|Secondary|Percentage of Participants With Any Adverse Event (AE)|An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events.|Up to 49 months approximately|Safety population included all participants who had received at least 1 dose of any study medication assigned to treatment arms as treated.||percentage of participants|||Number
686269|NCT01491737|Secondary|Change From Baseline in Health-Related Quality of Life as Determined by European Quality of Life 5-Dimension (EQ-5D) Visual Analog Scale (VAS) Scores|EQ-5D VAS: participant rated questionnaire to assess health-related quality of life (QoL) in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, every 3 cycles (21-day cycle), and every 3 months after treatment discontinuation (up to 49 months, approximately)|ITT population included all randomized participants. Here, ‘n’ number of participants who were evaluated at specified time point.||unit on a scale||Standard Deviation|Mean
686270|NCT01491737|Secondary|Clinical Benefit Response (CBR)|CBR is percentage of participants with best (confirmed) PR or CR or SD for at least 6 months. According to RECIST version 1.1, CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm; PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; stable disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|Baseline up to 49 months, approximately|ITT population included all randomized participants. Here, number of participants analyzed is the participants with measurable disease at baseline.||percentage of participants||95% Confidence Interval|Number
686271|NCT01491737|Secondary|Objective Overall Response Rate (ORR)|ORR was defined as participants with best (confirmed) overall response (BOR) of either CR or PR. ORR was assessed by the investigator according to RECIST version 1.1 and is based on BOR, which is defined as best response recorded from start of study treatment until disease progression/recurrence or death. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm; PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference baseline sum diameters; SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Participants needed to have two consecutive assessments of PR or CR to be a responder. Only participants with measurable disease at baseline were included in the analysis of BOR and who did not have any evaluable post-baseline assessments were classified as not evaluable.|Baseline up to 49 months, approximately|ITT population included all randomized participants. Here, number of participants analyzed are the participants who had measureable disease at baseline.||percentage of participants||95% Confidence Interval|Number
686272|NCT01491737|Secondary|Time to Response (TTR)|TTR was defined as the time from the date of randomization to the date of first CR or PR. According to RECIST version 1.1, CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm; PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. A censored time to response was calculated at the date of the last adequate tumor assessment as there was no date of confirmed response (CR or PR). If no tumor assessment is performed for the participant (or all post-baseline assessments are not evaluable or PD) the censoring day would be set to day 1 (date of randomization).|Baseline up to 49 months, approximately|ITT population included all randomized participants. Here, number of participants analyzed are the participants who were responders and had measurable disease at baseline.||months||95% Confidence Interval|Median
686273|NCT01491737|Secondary|Duration of Response (DOR)|DOR was defined as the period from the date of initial confirmed partial response (PR) or complete response (CR) until the date of progressive disease or death from any cause. According to RECIST version 1.1, CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm; PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Participants with no documented progression after CR or PR were censored at the last date at which they were known to have had the CR or PR, respectively.|Baseline up to 49 months, approximately|ITT population included all randomized participants. Here, number of participants analyzed are the participants who were responders and had measurable disease at baseline.||months||95% Confidence Interval|Median
686274|NCT01491737|Secondary|Overall Survival (OS)|OS is defined as the time from the date of randomization to the date of death, regardless of the cause of death. Participants who were alive at the time of the analysis were censored at the date of the last follow-up assessment. Participants without follow-up assessment were censored at the day of last study medication (pertuzumab, trastuzumab, AI or induction chemotherapy), and participants with no post-baseline information were censored at the date of randomization.|From the date of randomization until first documented death (approximately, up to 49 months)|ITT population included all randomized participants.||Months||95% Confidence Interval|Median
686275|NCT01491737|Primary|Progression-Free Survival (PFS)|PFS is defined as the time from randomization until the first radiographically documented progression of disease or death from any cause, whichever occurred first (either during study treatment or during follow-up). Progression of disease was evaluated according to the response evaluation criteria in solid tumors (RECIST) (version 1.1). Progressive disease is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (Note: the appearance of one or more new lesions is also considered progression). Participants with no PFS events were censored at the time of the last evaluable tumor assessment.|Baseline to progressive disease or death (approximately, up to 49 months)|ITT population included all randomized participants.||months||95% Confidence Interval|Median
686276|NCT01491672|Secondary|Duration of Response (DoR)|DoR was defined as the time from the first occurrence of PR or CR (as per local radiological review) until the date of the first documented disease progression or death due to underlying cancer.|20 months|The FAS was considered for this analysis. The FAS included all enrolled participants. Only participants who achieved a CR or PR were analyzed. Therefore, actual n=4,3,3,10.||months||95% Confidence Interval|Median
686277|NCT01491672|Secondary|Objective Response Rate (ORR)|ORR was defined as the proportion of participants with best overall response of CR or PR based on the local radiological data according to the RECIST 1.0 Criteria|20 months|The FAS was used. It included all enrolled participants.||Participants|||Number
686278|NCT01491672|Secondary|Clinical Benefit Rate (CBR)|CBR was defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR) or stable disease based on the local radiological data according to the RECIST 1.0 criteria.|20 months|The FAS was used. It included all enrolled participants.||Participants|||Number
686279|NCT01491672|Secondary|Overall Survival (OS)|OS was defined as the time from date of enrollment to date of death due to any cause.|28 months|The FAS was used. It included all enrolled participants.||months||95% Confidence Interval|Median
686280|NCT01491672|Secondary|Duration of PFS for Each First-line Treatment Cohort|Duration of PFS during second-line treatment was defined as the time from the date of enrollment to the date of the first documented disease progression or death due to any cause. Participants' assessment was based on the local radiological data according to the RECIST 1.0 Criteria.|20 months|The FAS was used. It included all enrolled participants.||months||95% Confidence Interval|Median
686281|NCT01491672|Primary|Progression-free Survival (PFS) - All Participants|PFS during second-line treatment was defined as the time from the date of enrollment to the date of the first documented disease progression or death due to any cause. The primary analysis of PFS was based on a local radiology review of CT scans and MRI collected until the participant experienced disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.0.|20 months|The full analysis set (FAS) was used. It included all enrolled participants.||months||95% Confidence Interval|Median
686282|NCT01491633|Post-Hoc|Time on Study|Number of days participant remained on study|2 years|||days||Standard Deviation|Mean
686283|NCT01491633|Secondary|Toxicities|Define the toxicities of dasatinib when administered to the patient population. NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 will be utilized for adverse event reporting.|2 years|||grade 3 toxicities|||Number
686284|NCT01491633|Secondary|Survival|Establish the overall survival of patients with SCC treated with dasatinib|2 years|One subject who was alive at the end of the study was censored from the survival analysis||days||Standard Deviation|Mean
686285|NCT01491633|Secondary|Types and Frequency of DDR2 Mutations|Determine frequency of DDR2 mutations in study patients|2 years|||participants|||Number
686286|NCT01491633|Primary|Response Rate|Determine the overall response rate of patients with squamous cell carcinoma of the lung treated with dasatinib|2 years|||percent|||Number
686287|NCT01491607|Secondary|Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards|Systemic reactions (fatigue/ tiredness, muscle ache, headache, and fever) were evaluated by using a web-enabled subject diary. Subjects assessed severity as absent, mild, moderate, or severe based on the degree of interference with daily activities. Severity of fever was assessed using a grading scale. Severe systemic reactions were to be recorded as adverse events by the investigator site staff after confirmation with the subject.|Web-enabled diaries were completed for 7 days after each of three injections (Days 0, 14, and 28).|The reporting group was subjects who had any diary data available during the 7-day-post-vaccination period (i.e., n=196, n=196, and n=193, for the1st, 2nd, and 3rd post-vaccination periods, respectively).||percentage of participants|||Number
686288|NCT01491607|Secondary|Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards|Systemic reactions (fatigue/ tiredness, muscle ache, headache, and fever) were evaluated by using a web-enabled subject diary. Subjects assessed severity as absent, mild, moderate, or severe based on the degree of interference with daily activities. Severity of fever was assessed using a grading scale. Severe systemic reactions were to be recorded as adverse events by the investigator site staff after confirmation with the subject.|Web-enabled diaries were completed for 7 days after each of three injections (Days 0, 14, and 28).|The reporting group was subjects who had any diary data available during the 7-day-post-vaccination period (i.e., n=196, n=196, and n=193, for the1st, 2nd, and 3rd post-vaccination periods, respectively).||participants|||Number
686345|NCT01490931|Secondary|Median Onset of Meaningful Pain Relief|Measure obtained using recognized double-stop watch technique. Patient is asked to depress the second stop watch when pain relief is meaningful to them. Each patient decides what meaningful relief is for them.|At time of depressing meaningful relief stopwatch up to 6 hours.|||seconds||95% Confidence Interval|Median
686346|NCT01490931|Secondary|Most Frequent Number of Days of Analgesic Dosing in Dental Implant Surgery Patients When Employing Intranasal Ketorolac as Their Pain Medication.|Self explanatory|Up to 5 days|||days|||Number
686289|NCT01491607|Secondary|Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards|Injection site reactions (warmth, tenderness, itching, pain, arm motion limitation, redness, lump, swelling, and bruise) were evaluated by using a web-enabled subject diary. Subjects assessed the severity of warmth, tenderness, itching, pain, arm motion limitation, lump, and bruise as absent, mild, moderate, or severe based on the degree of interference with daily activities. Severity of redness and swelling were based on the diameter of the affected area. Severe injection site reactions were recorded as adverse events by the investigator site staff after confirmation with the subject.|Web-enabled diaries were completed for 7 days after each of three injections (Days 0, 14, and 28).|The reporting group was subjects who had any diary data available during the 7-day-post-vaccination period (i.e., n=196, n=196, and n=193, for the1st, 2nd, and 3rd post-vaccination periods, respectively).||percentage of participants|||Number
686290|NCT01491607|Secondary|Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards|Injection site reactions (warmth, tenderness, itching, pain, arm motion limitation, redness, lump, swelling, and bruise) were evaluated by using a web-enabled subject diary. Subjects assessed the severity of warmth, tenderness, itching, pain, arm motion limitation, lump, and bruise as absent, mild, moderate, or severe based on the degree of interference with daily activities. Severity of redness and swelling were based on the diameter of the affected area. Severe injection site reactions were recorded as adverse events by the investigator site staff after confirmation with the subject.|Web-enabled diaries were completed for 7 days after each of three injections (Days 0, 14, and 28).|The reporting group was subjects who had any diary data available during the 7-day-post-vaccination period (i.e., n=196, n=196, and n=193, for the1st, 2nd, and 3rd post-vaccination periods, respectively).||participants|||Number
686291|NCT01491607|Secondary|Average Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value Between Days 63 and 100 (Inclusive).|Neutralizing antibody levels in blinded serum samples were measured using a validated anthrax lethal toxin neutralization assay. The primary assay endpoint was the 50% neutralization factor (TNA NF50), which is calculated as the ratio of the 50% effective dose (ED50) of the test sample to the ED50 of a reference serum.|Days 63 to 100|Participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days, Day 70 ± 2 days, Day 84 ± 3 days, and Day 100 ± 3 days, inclusive.||percentage of participants||95% Confidence Interval|Mean
686292|NCT01491607|Secondary|Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value at Day 70.|Neutralizing antibody levels in blinded serum samples were measured using a validated anthrax lethal toxin neutralization assay. The primary assay endpoint was the 50% neutralization factor (TNA NF50), which is calculated as the ratio of the 50% effective dose (ED50) of the test sample to the ED50 of a reference serum.|Day 70 +/- 2 days|Participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 70 ± 2 days.||percentage of participants||95% Confidence Interval|Least Squares Mean
686293|NCT01491607|Primary|Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value at Day 63 (5 Weeks Following the Third Vaccination on Day 28).|Neutralizing antibody levels in blinded serum samples were measured using a validated anthrax lethal toxin neutralization assay. The primary assay endpoint was the 50% neutralization factor (TNA NF50), which is calculated as the ratio of the 50% effective dose (ED50) of the test sample to the ED50 of a reference serum.|Day 63 +/- 2 days|Subjects who received all three doses of BioThrax within the allowable time window and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by Sponsor) on Day 63 were excluded.||percentage of participants||95% Confidence Interval|Mean
686294|NCT01491490|Primary|Change in Bodyweight.|Efficacy of a 40:1 ratio of GWP42003:GWP42004 compared with placebo in the change from baseline in body weight after 42 days (6 weeks) in subjects currently being treated with olanzapine for schizophrenia or other non-affective psychosis.|6 weeks from Baseline.|||Kg|||Number
686295|NCT01491113|Secondary|Hemodialysis Clearance (CLHD) of Ucb L059 (LEV) During First Dialysis for Group E|Calculated according: CLHD=CLD+CLUF.|From 44 hours to 48 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.||mL/min||Geometric Coefficient of Variation|Geometric Mean
686296|NCT01491113|Secondary|Ultrafiltration Clearance (CLUF) of Ucb L059 (LEV) During First Dialysis for Group E|Calculated by the Arterio - Venous difference method and cumulative dialysate method.|From 44 hours to 48 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.||mL/min||Geometric Coefficient of Variation|Geometric Mean
686297|NCT01491113|Secondary|Hemodialysis Clearance (CLD) of Ucb L059 (LEV) During First Dialysis for Group E|Calculated by the Arterio - Venous difference method and cumulative dialysate method.|From 44 hours to 48 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.||mL/min||Geometric Coefficient of Variation|Geometric Mean
686298|NCT01491113|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Ucb L057 for Group E During First Period|tmax refers to the time to reach maximum plasma concentration (tmax).|From Baseline to 44 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.||hours||Full Range|Median
686347|NCT01490931|Secondary|Percentage of Subjects Who Reach a Level of at Least Moderate Pain by Achieving a Score of at Least 40 mm on a 100 mm Visual Analog Scale Within 5 Hours After the Completion of Surgery.||Up to 5 hours after last suture is placed|All subjects (regardless of pain intensity) receiving one to three dental implants||percentage of participants|||Number
686299|NCT01491113|Secondary|Terminal Half-life (t1/2) of Ucb L059 (LEV) for Group E During First Period|"Terminal half-life refers to the time it takes for the concentrations to decrease by half.
Geometric mean and CV was not calculated since the extrapolated part of the AUC was greater than 20 %."|From Baseline to 44 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.||hours||Full Range|Median
686300|NCT01491113|Secondary|Area Under the Concentration-time Curve (AUC) of Ucb L059 (LEV) From Baseline to Infinite for Group E|"AUC(0-t) refers to the area under the plasma concentration versus time curve, which provides information on the exposure.
Geometric mean and CV was not calculated since the extrapolated part of the AUC was greater than 20 %."|From Baseline to 140 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.||h*µg/mL||Full Range|Median
686301|NCT01491113|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Ucb L059 (Levetiracetam) for Group E During First Period|tmax refers to the time to reach the maximum plasma concentration of ucb L059 (Levetiracetam).|From Baseline to 44 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.||hours||Full Range|Median
686302|NCT01491113|Secondary|Terminal Half-life (t1/2) of Ucb L057 for Groups A to D|"Terminal half-life refers to the time it takes for the concentrations to decrease by half.
Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours"|From Baseline up to 144 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.||hours||Full Range|Median
686303|NCT01491113|Secondary|Area Under the Concentration-time Curve (AUC) of Ucb L057 From Baseline to Infinite for Groups A to D|"AUC(0-t) refers to the area under the plasma concentration versus time curve, which provides information on the exposure.
Geometric mean and CV was not calculated since the extrapolated part of the AUC was greater than 20 %.
Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours"|From Baseline up to 144 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.||h*µg/mL||Full Range|Median
686304|NCT01491113|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Ucb L057 for Groups A to D|"tmax refers to the time to reach maximum plasma concentration (tmax).
Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours"|From Baseline up to 144 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.||hours||Full Range|Median
686305|NCT01491113|Secondary|Terminal Half-life (t1/2) of Ucb L059 (LEV) for Groups A to D|"Terminal half-life refers to the time it takes for the concentrations to decrease by half.
Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours"|From Baseline up to 144 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.||hours||Geometric Coefficient of Variation|Geometric Mean
686306|NCT01491113|Secondary|Area Under the Concentration-time Curve (AUC) of Ucb L059 (LEV) From Baseline to Infinite for Groups A to D|"AUC(0-t) refers to the area under the plasma concentration versus time curve, which provides information on the exposure.
Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours"|From Baseline up to 144 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.||h*µg/mL||Geometric Coefficient of Variation|Geometric Mean
686307|NCT01491113|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Ucb L059 (LEV) for Groups A to D|"tmax refers to the time to reach maximum plasma concentration of ucb L059 (Levetiracetam).
Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours"|From Baseline up to 144 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.||hours||Full Range|Median
686308|NCT01491113|Secondary|Apparent Total Body Clearance (CL/F) of Ucb L059 (LEV) for Group E During First Period|"Clearance (expressed as volume/time) describes the removal of drug from a volume of plasma in a given unit of time (drug loss from the body). It indicates the volume of plasma (or blood) from which the drug is completely removed, or cleared, in a given time period.
Geometric mean and Coefficient of Variation (CV) was not calculated since the extrapolated part of the AUC was greater than 20 %."|From Baseline to 44 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.||L/h||Full Range|Median
686309|NCT01491113|Secondary|Renal Clearance (CLR) of Ucb L057 for Groups A to D|"Renal clearance describes the removal of drug from a volume of plasma in a given unit of time by the kidneys.
Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours"|From Baseline up to 144 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.||L/h||Geometric Coefficient of Variation|Geometric Mean
686310|NCT01491113|Secondary|Total Amount Excreted in Urine (Ae) of Ucb L057 for Groups A to D|"Ae refers to the total amount of ucb L057 excreted in urine.
Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours"|From Baseline up to 144 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.||mg||Geometric Coefficient of Variation|Geometric Mean
686311|NCT01491113|Secondary|Nonrenal Clearance (CLNR) of Ucb L059 (LEV) for Groups A to D|"The Non-Renal Clearance (CLNR) describes the removal of drug by organs other than the kidneys.
Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours"|From Baseline up to 144 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.||L/h||Geometric Coefficient of Variation|Geometric Mean
686312|NCT01491113|Secondary|Apparent Total Body Clearance (CL/F) of Ucb L059 (LEV) for Groups A to D|"Clearance (expressed as volume/time) describes the removal of drug from a volume of plasma in a given unit of time (drug loss from the body). It indicates the volume of plasma (or blood) from which the drug is completely removed, or cleared, in a given time period.
Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours"|From Baseline up to 144 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.||L/h||Geometric Coefficient of Variation|Geometric Mean
686313|NCT01491113|Secondary|Renal Clearance (CLR) of Ucb L059 (LEV) for Groups A to D|"Renal clearance describes the removal of drug from a volume of plasma in a given unit of time by the kidneys.
Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours"|From Baseline up to 144 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.||L/h||Geometric Coefficient of Variation|Geometric Mean
686314|NCT01491113|Secondary|Fraction of Dose Excreted in Urine (fe) of Ucb L059 (LEV) for Groups A to D|"fe refers to the fraction of dose excreted in urine of L059 (Levetiracetam).
Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours"|From Baseline up to 144 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.||Percentage of Dose Administered||Geometric Coefficient of Variation|Geometric Mean
686315|NCT01491113|Secondary|Total Amount Excreted in Urine (Ae) of Ucb L059 (LEV) for Groups A to D|"Ae refers to the total amount of ucb L059 (Levetiracetam) excreted in urine.
Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours"|From Baseline up to 144 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.||mg||Geometric Coefficient of Variation|Geometric Mean
686316|NCT01491113|Primary|Area Under the Concentration-time Curve (AUC(0-t)) of Ucb L057 From Baseline to 44 Hours for Group E|AUC(0-t) refers to the area under the plasma concentration versus time curve, which provides information on the exposure.|From Baseline to 44 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.||h*µg/mL||Geometric Coefficient of Variation|Geometric Mean
686317|NCT01491113|Primary|Maximum Observed Plasma Concentration (Cmax) of Ucb L057 for Group E During First Period|Cmax refers to the maximum observed concentration of ucb L057.|From Baseline to 44 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
686318|NCT01491113|Primary|Area Under the Concentration-time Curve (AUC(0-t)) of Ucb L059 (LEV) From Baseline to 44 Hours for Group E|AUC(0-t) refers to the area under the plasma concentration versus time curve, which provides information on the exposure.|From Baseline to 44 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.||h*µg/mL||Geometric Coefficient of Variation|Geometric Mean
686319|NCT01491113|Primary|Maximum Observed Plasma Concentration (Cmax) of Ucb L059 (LEV) for Group E During First Period|Cmax refers to the maximum observed concentration of ucb L059 (Levetiracetam).|From Baseline to 44 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
686320|NCT01491113|Primary|Area Under the Concentration-time Curve (AUC(0-t)) of Ucb L057 From Baseline to the Last Quantifiable Concentration for Groups A to D|"AUC(0-t) refers to the area under the plasma concentration versus time curve, which provides information on the exposure.
Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours"|From Baseline up to 144 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.||h*µg/mL||Geometric Coefficient of Variation|Geometric Mean
686321|NCT01491113|Primary|Maximum Observed Plasma Concentration (Cmax) of Ucb L057 for Groups A to D|"Cmax refers to the maximum observed concentration of ucb L057.
Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours"|From Baseline up to 144 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
686322|NCT01491113|Primary|Area Under the Concentration-time Curve (AUC(0-t)) of Ucb L059 (LEV) From Baseline to the Last Quantifiable Concentration for Groups A to D|"AUC(0-t) refers to the area under the plasma concentration versus time curve, which provides information on the exposure.
Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours"|From Baseline up to 144 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.||h*µg/mL||Geometric Coefficient of Variation|Geometric Mean
686323|NCT01491113|Primary|Maximum Observed Plasma Concentration (Cmax) of Ucb L059 (LEV) for Groups A to D|"Cmax refers to the maximum observed concentration of L059 (Levetiracetam).
Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours"|From Baseline up to 144 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
686324|NCT01491035|Primary|Oral Clearance (CL/F) of Vortioxetine|Oral clearance expressed as a function of bioavailability|Pre-dose and 1, 3, 5, 8, 12 and 24 hours post-dose on Day 14, 16, 18 or 20, depending on assigned dose level|Pharmacokinetic analysis set||L/h||Standard Deviation|Median
686325|NCT01491035|Primary|t½ of Lu AA34443|Half-life of the major, inactive metabolite Lu AA34443 in plasma|Pre-dose and 1, 3, 5, 8, 12 and 24 hours post-dose on Day 14, 16, 18 or 20, depending on assigned dose level|Pharmacokinetic analysis set||h||Standard Deviation|Median
686326|NCT01491035|Primary|AUC(0-24h) of Lu AA34443|Area under the plasma concentration-time curve from 0 to 24 hours for the major, inactive metabolite Lu AA34443|Pre-dose and 1, 3, 5, 8, 12 and 24 hours post-dose on Day 14, 16, 18 or 20, depending on assigned dose level|Pharmacokinetic analysis set||ng*h/mL||Standard Deviation|Median
686327|NCT01491035|Primary|Cmax of Lu AA34443|Maximum plasma concentration of the major, inactive metabolite Lu AA34443|Pre-dose and 1, 3, 5, 8, 12 and 24 hours post-dose on Day 14, 16, 18, or 20, depending on assigned dose level|Pharmacokinetic analysis set||ng/mL||Standard Deviation|Median
686328|NCT01491035|Primary|t½ of Vortioxetine|Half-life of vortioxetine in plasma|Pre-dose and 1, 3, 5, 8, 12 and 24 hours post-dose on Day 14, 16, 18 or 20, depending on assigned dose level|Pharmacokinetic analysis set||h||Standard Deviation|Median
686329|NCT01491035|Primary|AUC(0-24h) of Vortioxetine|Area under the vortioxetine plasma concentration-time curve from 0 to 24 hours|Pre-dose and 1, 3, 5, 8, 12 and 24 hours post-dose on Day 14, 16, 18 or 20, depending on assigned dose level|Pharmacokinetic analysis set||ng*h/mL||Standard Deviation|Median
686330|NCT01491035|Primary|Cmax of Vortioxetine|Maximum plasma concentration of vortioxetine|Pre-dose and 1, 3, 5, 8, 12 and 24 hours post-dose on Day 14, 16, 18, or 20, depending on assigned dose level|Pharmacokinetic analysis set = all patients who took at least one dose of IMP and who contributed with both Day 1 pre-dose pharmacokinetic sampling data and sufficient post-dose sampling data for estimation of the pharmacokinetic parameters.||ng/mL||Standard Deviation|Median
686331|NCT01491022|Secondary|Change in Stride Legth|change in stride length as measured by 3 D capture analysis|4 weeks|||meters||Standard Deviation|Mean
686332|NCT01491022|Secondary|Timed 25-foot Walk Test (T25FW)|time required to perform T25FW.|4 weeks|||seconds||Standard Error|Mean
686333|NCT01491022|Secondary|Timed Up and Go (TUG) Score|time required to perform TUG.|4 weeks|||seconds||Standard Error|Mean
686334|NCT01491022|Secondary|Freezing of Gait Questionnaire (FOGQ)|change in FOGQ score 0- 16, where 0 is normal, 16 is severely impaired|4 weeks|||units on a scale||Standard Deviation|Mean
686335|NCT01491022|Secondary|United Parkinson's Disease Rating Scale Score(UPDRS) ,|change in UPDRS score (motor) range 0-104, where 0 is good and 104 is worse.|4 weeks|||units on a scale||Standard Error|Mean
686336|NCT01491022|Primary|Change in Velocity|The primary outcome measure will be the change in gait velocity as measured with by 3-dimensional gait analysis system.|baseline and 4 weeks|||m/s||Standard Deviation|Mean
686337|NCT01490931|Primary|Comparison of Pain Intensity Scores at 6 Hours With the Baseline Pain Intensity Score During the Initial 6-hour Evaluation Period||6 Hours post-dose|||millimeters||Standard Error|Mean
686338|NCT01490931|Primary|Comparison of Pain Intensity Scores at 5 Hours With the Baseline Pain Intensity Score During the Initial 6-hour Evaluation Period||5 Hours post-dose|||millimeters||Standard Error|Mean
686339|NCT01490931|Primary|Comparison of Pain Intensity Scores at 4 Hours With the Baseline Pain Intensity Score During the Initial 6-hour Evaluation Period||4 Hours post-dose|||millimeters||Standard Error|Mean
686340|NCT01490931|Primary|Comparison of Pain Intensity Scores at 3 Hours With the Baseline Pain Intensity Score During the Initial 6-hour Evaluation Period||3 hours post-dose|||millimeters||Standard Error|Mean
686341|NCT01490931|Primary|Comparison of Pain Intensity Scores at 2 Hours With the Baseline Pain Intensity Score During the Initial 6-hour Evaluation Period||2 Hours|||millimeters||Standard Error|Mean
686342|NCT01490931|Primary|Comparison of Pain Intensity Scores at 90 Minutes With the Baseline Pain Intensity Score During the Initial 6-hour Evaluation Period||90 minutes post-dose|||millimeters||Standard Error|Mean
686343|NCT01490931|Primary|Comparison of Pain Intensity Scores at 60 Minutes With the Baseline Pain Intensity Score During the Initial 6-hour Evaluation Period|VAS pain intensity score 60 minutes after dosing.|60 minutes post dose|||millimeters||Standard Error|Mean
686344|NCT01490931|Primary|Comparison of Pain Intensity Scores at 40 Minutes With the Baseline Pain Intensity Score During the Initial 6-hour Evaluation Period.|VAS pain intensity score at 40 minutes post-dose|40 minutes post dose|||millimeters||Standard Error|Mean
686353|NCT01490866|Secondary|Objective Response Rate|Defined as the percentage of evaluable patients showing a complete or partial response (CR or PR) per RECIST v1.1 criteria. CR = disappearance of all lesions. PR = at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Stable disease (SD) = neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest (nadir) sum LD since start of treatment.|every 8 weeks, assessed up to approximately 24 months|||percentage of participants|||Number
686354|NCT01490866|Primary|Progression-free Survival|Defined as the time from first treatment until objective tumor progression or death from any cause, assessed according to Response Evaluation Criteria for Solid Tumors (RECIST) v1.1.|24 months|All patients who received at least one dose of any study drug.||months||95% Confidence Interval|Median
686355|NCT01490840|Secondary|Change From Baseline in Peak Expiratory Flow as Measured by a Physical Endurance Spiroergometry on a Treadmill|Physical endurance spiroergometry was accomplished. Ergometry was assessed according to national guidelines of the German society for sports medicine. Ergometry is a combined examination of circulation and lung function and was performed as a submaximal or maximal test depending on the participant's individual performance. A positive change from baseline indicates improvement.|Baseline, 6 months|The ModFAS, which included participants with sufficient e-training compliance, was considered for the analysis. Only participants with both baseline and month 6 values were analyzed.||L/s||95% Confidence Interval|Least Squares Mean
686356|NCT01490840|Secondary|Change From Baseline in Aerobic Capacity (VO2max) as Measured by a Physical Endurance Spiroergometry on a Treadmill|Physical endurance spiroergometry was accomplished. Ergometry was assessed according to national guidelines of the German society for sports medicine. Ergometry is a combined examination of circulation and lung function and was performed as a submaximal or maximal test depending on the participant's individual performance. A negative change from baseline indicates improvement.|Baseline, 6 months|Modified Full Analysis Set (ModFAS): The ModFAS included participants with sufficient e-training compliance.||[ml/min/kg][watt/kg body weight]||95% Confidence Interval|Least Squares Mean
686357|NCT01490840|Secondary|Change From Baseline in Depression as Measured by the Beck Depression Inventory Second Edition (BDI-II)|The Beck Depression Inventory Second Edition (BDI-II) is a 21-item self-report instrument intended to assess the existence and severity of symptoms of depression as listed in the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders Fourth Edition. Each of the 21 items corresponding to a symptom of depression is summed to give a single score for the BDI-II. There is a four-point scale for each item ranging from 0 to 3. The total score ranges from 0 - 63. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe. A negative change from baseline indicates improvement.|Baseline, 6 months|Modified Full Analysis Set (ModFAS): The ModFAS included participants with sufficient e-training compliance.||score on a scale||95% Confidence Interval|Least Squares Mean
686358|NCT01490840|Secondary|Change From Baseline in Fatigue as Measured by the WEIMuS (Würzburg Fatigue Inventory for MS)|The WEIMuS (Würzburg Fatigue Inventory for MS) scale is a validated self-assessment instrument to quantify the degree of fatigue. The scale consists of 17 items with 5 categories that are scored from ‘0’ to ‘4’. The subscores for cognitive and physical fatigue range from 0 to 36 and from 0 to 32, respectively, with the total sum score ranging from 0 to 68; higher scores indicate higher degrees of fatigue. A negative change from baseline indicates improvement.|Baseline, 6 months|Modified Full Analysis Set (ModFAS): The ModFAS included participants with sufficient e-training compliance.||score on a scale||95% Confidence Interval|Least Squares Mean
686359|NCT01490840|Secondary|Change From Baseline in Quality of Life as Measured by the Hamburg Quality of Life Questionnaire in Multiple Sclerosis (HAQUAMS)|The Hamburg Quality of Life Questionnaire in Multiple Sclerosis (HAQUAMS) consists of 44 items, 28 of which are the basis for computation of five subscale scores reflecting major dimensions of health-related quality of life (HRQoL) in MS: Fatigue/Thinking (4 items), Mobility lower limb (5 items), Mobility upper limb (5 items), Social function (6 items) and Mood (eight items). Subscales and total score range from 1 to 5, with high scores indicating a lower quality of life. In this study, the total score and following 3 subscales: fatigue/thinking, mobility lower limb and mobility upper limb only were analyzed. A negative change from baseline indicates improvement.|Baseline, 6 months, 12 months|Modified Full Analysis Set (ModFAS): The ModFAS included participants with sufficient e-training compliance.||score on a scale||95% Confidence Interval|Least Squares Mean
686360|NCT01490840|Secondary|Change From Baseline in Isometric and Dynamic Muscular Strength as Measured by Leg Strength Endurance|"Isometric and dynamic muscular strength was measured by an Isomed 2000 isometric measurement device (knee flexion/tension, trunk flexion/extension).
Isomed 2000 device measures muscular flexion and tension under standardized training conditions. A positive change from baseline indicates improvement."|baseline, 6 months|Modified Full Analysis Set (ModFAS): The ModFAS included participants with sufficient e-training compliance.||joule||95% Confidence Interval|Least Squares Mean
686361|NCT01490840|Secondary|Change From Baseline in Isometric and Dynamic Muscular Strength as Measured by Change in Leg Strength and Trunk Strength|"Isometric and dynamic muscular strength was measured by an Isomed 2000 isometric measurement device (knee flexion/tension, trunk flexion/extension).
Isomed 2000 device measures muscular flexion and tension under standardized training conditions. A positive change from baseline indicates improvement."|baseline, 6 months|Modified Full Analysis Set (ModFAS): The ModFAS included participants with sufficient e-training compliance.||newton meter||95% Confidence Interval|Least Squares Mean
686362|NCT01490840|Secondary|Change From Baseline in Isometric and Dynamic Muscular Strength as Measured by Sit-to-stand Test|The Sit to Stand Test is a functional outcome measure of the lower-extremity muscle power. The test was performed 3 times with one minute rest in between. The best attempt out of three was used for the analysis. A positive change from baseline indicates improvement.|baseline, 6 months|The ModFAS, which included participants with sufficient e-training compliance, was considered for the analysis. Only participants with both baseline and month 6 values were analyzed.||watt/kilogram body weight||95% Confidence Interval|Least Squares Mean
686459|NCT01490190|Primary|Number of Participants With Intermenstrual Bleeding/Spotting|Number of participants who experienced vaginal bleeding, which includes BLEEDING or SPOTTING, at any time during a cycle other than normal menstruation while in the study. Vaginal bleeding that required >=2 pads per day was classified as BLEEDING. Vaginal bleeding that required <=1 pad per day was classified as SPOTTING.|Up to 84 days (three 28-day cycles)|Per Protocol Population, which included all participants who completed the study as per protocol.||Participants|||Number
686363|NCT01490840|Primary|Change From Baseline in Fatigue as Measured by the Modified Fatigue Impact Scale (mFIS ).|The mFIS provides an assessment of the effects of fatigue in terms of physical, cognitive, and psychosocial functioning. It is a 21-item, structured, self-report questionnaire that generally can be completed with little or no intervention from an interviewer. The mFIS score ranged from 0 (not tired) to 84 (tired). A negative change from baseline indicates improvement.|Baseline, 6 months|Modified Full Analysis Set (ModFAS): The ModFAS included participants with sufficient e-training compliance.||score on a scale||95% Confidence Interval|Least Squares Mean
686364|NCT01490697|Secondary|Change From Baseline in the Impact of Event Scale-Revised (IES-R) Total Score|IES-R is a 22-item patient reported measure of PTSD symptoms. Each question is answered using a 5-point scale where 0=not at all to 4=extremely for a total possible score of 0 to 88. Lower scores represent less severe symptoms and higher scores representing more severe symptoms. IES-R change scores were calculated by subtracting the Day 14 IES-R total score from the Day 7 IES-R total score. A negative change from Baseline indicates improvement of symptoms and a positive change from Baseline indicates a worsening of symptoms.|Day 7 (Baseline) and Day 14|All randomized participants included in the analysis. Three participants did not meet PTSD diagnostic criteria and are excluded.||score on a scale||Standard Deviation|Mean
686365|NCT01490697|Primary|Physiological Posttraumatic Stress Disorder (PTSD) Probability as Determined From Psychophysiologic Responses to Traumatic Recollection|The posterior probability of developing PTSD was determined for each participant from a composite of psychophysiological responses to script-driven imagery of traumatic events that included assessments of heart rate response in beats per minute, skin conductance response in microSiemens, and corrugator electromyogram (EMG) responses of the left lateral frontalis facial muscle in microVolts. Responses for the traumatic scripts were averaged and square-root transformed for analysis. Responses during personal traumatic imagery of previously studied individuals with and without current PTSD was used to calculate each participant's posterior probability of being classified as PTSD.|1 week following treatment (Day 14)|All randomized participants included in the analysis. Three participants did not meet PTSD diagnostic criteria and are excluded.||percent probability||Standard Deviation|Mean
686366|NCT01490632|Secondary|PK: Area Under the Concentration-Time Curve Versus Time During One Dosing Interval at Steady State (AUC τ,ss)||Day 1:15 minutes(m) to 30m and 1hour(h) to 3h Postdose; Week 1:Predose; Week 4:Predose; Week 8:Predose; 15m to 30m and 1h to 3h Postdose, Week 12:Predose; Weeks 14 and 20; Week 24:Predose; Week 28; Week 40. If applicable: Weeks 4, 24, and 52 Post-Relapse|All randomized participants who received ≥1 dose of study drug in Part A, had evaluable PK, and participated in Part A, B or C. Some participants received 4mg or 8 mg and increased to 8mg or 10 mg, depending on the response at week 12. Those participants are treated as separate participants in each dose group.||nanomole*hour (nM*h)||Geometric Coefficient of Variation|Geometric Mean
686367|NCT01490632|Secondary|Pharmacokinetics (PK): Maximum Concentration at Steady State of Dosing (Cmax,ss) of Baricitinib||Day 1:15 minutes(m) to 30m and 1hour(h) to 3h Postdose; Week 1:Predose; Week 4:Predose; Week 8:Predose; 15m to 30m and 1h to 3h Postdose, Week 12:Predose; Weeks 14 and 20; Week 24:Predose; Week 28; Week 40. If applicable: Weeks 4, 24, and 52 Post-Relapse|All randomized participants who received ≥1 dose of study drug in Part A, had evaluable PK, and participated in Part C. Some participants received 4mg or 8 mg and increased to 8mg or 10 mg, depending on the response at week 12. Those participants are treated as separate participants in each dose group.||nanomole (nM)||Geometric Coefficient of Variation|Geometric Mean
686368|NCT01490632|Secondary|Percentage of Participants Experiencing Rebound Upon Discontinuation of Study Drug in Part C|Rebound was defined as worsening of psoriasis compared to baseline at Week 0 (for example, PASI score >125% of baseline value) or new pustular, erythrodermic, or more inflammatory psoriasis occurring within 3 months of stopping study drug.|Week 40|All randomized participants who received ≥1 dose of study drug in Part A and participated in Part C.||Percentage of Participants|||Number
686369|NCT01490632|Secondary|Change From Baseline Part D in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Scores|"The EQ-5D-5L is a standardized measure of health status of the participant. One of two portions of the EQ-5D-5L was used in which a self-perceived health score is assessed using a visual analogue scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 mm indicated the worst health you can imagine and 100 mm indicated the best health you can imagine. This information is used as a quantitative measure of health outcome."|Baseline Part D, Week 92|All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline EQ-5D-5L observation. Missing values were imputed with the last observation carried forward (LOCF) method.||mm||Standard Deviation|Mean
686370|NCT01490632|Secondary|Change From Baseline Part A in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Scores|"The EQ-5D-5L is a standardized measure of health status of the participant. One of two portions of the EQ-5D-5L was used in which a self-perceived health score is assessed using a visual analogue scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 mm indicated the worst health you can imagine and 100 mm indicated the best health you can imagine. This information is used as a quantitative measure of health outcome."|Baseline Part A, Week 24|All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline EQ-5D-5L observation. As observed values were used.||mm||Standard Deviation|Mean
686371|NCT01490632|Secondary|Change From Baseline Part A in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Scores|"The EQ-5D-5L is a standardized measure of health status of the participant. One of two portions of the EQ-5D-5L was used in which a self-perceived health score is assessed using a visual analogue scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 mm indicated the worst health you can imagine and 100 mm indicated the best health you can imagine. This information is used as a quantitative measure of health outcome. LS Means were calculated using MMRM with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects."|Baseline Part A, Week 12|All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline EQ-5D-5L observation. As observed values were used.||Millimeter (mm)||Standard Error|Least Squares Mean
686395|NCT01490294|Secondary|Assessment of Contrast Quality of Delayed Enhancement (DE) at 20 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.|Delayed enhancement was measured at 20 minutes after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.||Participants|||Number
686372|NCT01490632|Secondary|Change From Baseline Part D in Quick Inventory of Depressive Symptomatology-Self Report 16 Items (QIDS-SR16) Total Score to Week 92|The QIDS-SR16 is a 16-item, self-report instrument intended to assess the existence and severity of symptoms of depression as listed in the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) (APA 1994). A participant is asked to consider each statement as it relates to the way they have felt for the past 7 days. There is a 4-point scale for each item ranging from 0 to 3. The 16 items corresponding to 9 depression domains are summed to give a single score ranging from 0 to 27, with higher scores denoting greater symptom severity. The domains assessed by the instrument include: (1) sad mood, (2) concentration, (3) self-criticism, (4) suicidal ideation, (5) interest, (6) energy/fatigue, (7) sleep disturbance (initial, middle, and late insomnia or hypersomnia), (8) decrease/increase in appetite/weight, and (9) psychomotor agitation/retardation.|Baseline Part D, Week 92|All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline QIDS-SR16 observation. Missing values were imputed with the last observation carried forward (LOCF) method.||Units on a Scale||Standard Deviation|Mean
686373|NCT01490632|Secondary|Change From Baseline Part A in Quick Inventory of Depressive Symptomatology-Self Report 16 Items (QIDS-SR16) Total Score to Week 24|The QIDS-SR16 is a 16-item, self-report instrument intended to assess the existence and severity of symptoms of depression as listed in the American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) (APA 1994). A participant is asked to consider each statement as it relates to the way they have felt for the past 7 days. There is a 4-point scale for each item ranging from 0 to 3. The 16 items corresponding to 9 depression domains are summed to give a single score ranging from 0 to 27, with higher scores denoting greater symptom severity. The domains assessed by the instrument include: (1) sad mood, (2) concentration, (3) self-criticism, (4) suicidal ideation, (5) interest, (6) energy/fatigue, (7) sleep disturbance (initial, middle, and late insomnia or hypersomnia), (8) decrease/increase in appetite/weight, and (9) psychomotor agitation/retardation.|Baseline Part A, Week 24|All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline QIDS-SR16 observation. As observed values were used.||Units on a Scale||Standard Deviation|Mean
686374|NCT01490632|Secondary|Change From Baseline Part A in Quick Inventory of Depressive Symptomatology-Self Report 16 Items (QIDS-SR16) Total Score at Week 12|The 16-item QIDS-SR16 version is a widely used validated scale designed to assess the severity of depressive symptoms. The participant was asked to rate the severity and frequency of specific symptoms present over the last 7 days. The QIDS-SR16 total scores range from 0 to 27, where higher scores indicate higher severity of symptoms. LS Means were calculated using MMRM with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.|Baseline Part A, Week 12|All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline QIDS-SR16 observation. Missing values were imputed with the last observation carried forward (LOCF) method.||Units on a Scale||Standard Error|Least Squares Mean
686375|NCT01490632|Secondary|Change From Baseline Part D in Itch Numeric Rating Scale (Itch NRS) Score to Week 92|The Itch NRS is a participant-administered, 11‑point horizontal scale anchored at 0 and 10, with 0 representing “no itch” and 10 representing “worst itch imaginable.” Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours.|Baseline Part D, Week 92|All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline Itch NRS observation. Missing values were imputed with the last observation carried forward (LOCF) method.||Units on a Scale||Standard Deviation|Mean
686376|NCT01490632|Secondary|Change From Baseline Part A in Itch Numeric Rating Scale (Itch NRS) Score to Week 24|The Itch NRS is a participant-administered, 11‑point horizontal scale anchored at 0 and 10, with 0 representing “no itch” and 10 representing “worst itch imaginable.” Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours.|Baseline Part A, Week 24|All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline Itch NRS observation. Missing values were imputed with the last observation carried forward (LOCF) method.||Units on a Scale||Standard Deviation|Mean
686377|NCT01490632|Secondary|Change From Baseline Part A in Itch Numeric Rating Scale (Itch NRS) Score at Week 12|The Itch NRS is a participant-administered, 11‑point horizontal scale anchored at 0 and 10, with 0 representing “no itch” and 10 representing “worst itch imaginable.” Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours. LS Means were calculated using MMRM with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.|Baseline Part A, Week 12|All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline Itch NRS observation. Missing values were imputed with the last observation carried forward (LOCF) method.||Units on a Scale||Standard Error|Least Squares Mean
686378|NCT01490632|Secondary|Change From Baseline Part D in Dermatology Life Quality Index (DLQI) Total Score to Week 92|"The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include not at all, a lot, and very much, with corresponding scores of 1, 2, and 3, respectively, and unanswered (not relevant) responses scored as 0. Totals range from 0 to 30 (less to more impairment), and a 5 point change from baseline is considered clinically relevant."|Baseline Part D, Week 92|All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline DLQI observation. Missing values were imputed with the last observation carried forward (LOCF) method.||Units on a Scale||Standard Deviation|Mean
686396|NCT01490294|Secondary|Assessment of Contrast Quality of Delayed Enhancement (DE) at 20 Minutes Post Injection According to Blinded Reading (Only Participants With DE in at Least One Segment, PPS)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Assessments of participants and/or segments by the individual blinded readers could differ. For the average reader, the results of the 3 individual readers are summarized.|Delayed enhancement was measured at 20 minutes after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.||Delayed enhancement assessments|Participants||Number
686379|NCT01490632|Secondary|Change From Baseline Part A in Dermatology Life Quality Index (DLQI) Total Score to Week 24|"The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include not at all, a lot, and very much, with corresponding scores of 1, 2, and 3, respectively, and unanswered (not relevant) responses scored as 0. Totals range from 0 to 30 (less to more impairment), and a 5 point change from baseline is considered clinically relevant."|Baseline Part A, Week 24|All randomized participants who received ≥1 dose of study drug in Part B and had ≥1 evaluable post-baseline DLQI observation. Missing values were imputed with the last observation carried forward (LOCF) method.||Units on a Scale||Standard Deviation|Mean
686380|NCT01490632|Secondary|Change From Baseline Part A in Dermatology Life Quality Index (DLQI) Total Score to Week 12|"The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include not at all, a lot, and very much, with corresponding scores of 1, 2, and 3, respectively, and unanswered (not relevant) responses scored as 0. Totals range from 0 to 30 (less to more impairment), and a 5 point change from baseline is considered clinically relevant. Least Square (LS) Means in total DLQI score were calculated using Mixed Model Repeated Measures (MMRM) with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects."|Baseline Part A, Week 12|All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline DLQI observation. Missing values were imputed with the last observation carried forward (LOCF) method.||Units on a Scale||Standard Error|Least Squares Mean
686381|NCT01490632|Secondary|Change From Baseline in Part D in Mean Psoriasis Area and Severity Index (PASI) Total Score to Week 92 (Efficacy of Baricitinib in Participants With Moderate to Severe Plaque Psoriasis. Measure: Psoriasis Area and Severity Index [PASI])|The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease.|Baseline Part D, Week 92|All randomized participants who received ≥1 dose of study drug and has 1 post-baseline observation at or prior to week 92. Missing values were imputed with the last observation carried forward (LOCF) method.||Units on a Scale||Standard Deviation|Mean
686382|NCT01490632|Secondary|Change From Baseline in Part A in Mean Psoriasis Area and Severity Index (PASI) Total Score to Week 24 (Efficacy of Baricitinib in Participants With Moderate to Severe Plaque Psoriasis: Measure: Psoriasis Area and Severity Index [PASI])|The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease.|Baseline Part A, Week 24|All randomized participants who received at least one dose of study drug and at least 1 post-baseline observation in Part A at or prior to week 24. Missing values were imputed with the last observation carried forward (LOCF) method.||Units on a Scale||Standard Deviation|Mean
686383|NCT01490632|Secondary|Change From Baseline in Part A in Mean Psoriasis Area and Severity Index (PASI) Total Score to Week 12 (Efficacy of Baricitinib in Participants With Moderate to Severe Plaque Psoriasis. Measure: Psoriasis Area and Severity Index [PASI])|The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease. Least Squares Means (LS Means) were calculated using an analysis of covariance (ANCOVA) model on the last observation carried forward (LOCF) with treatment group as a fixed effect and baseline PASI score as a continuous covariate.|Baseline Part A, Week 12|All randomized participants who received at least one dose of study drug. Missing values were imputed with the last observation carried forward (LOCF) method.||Units on a Scale||Standard Error|Least Squares Mean
686384|NCT01490632|Secondary|Percentage of Participants Achieving an sPGA of (0, 1) (Efficacy of Baricitinib in Participants With Moderate to Severe Plaque Psoriasis. Measure: Static Physician Global Assessment [sPGA])|The sPGA is a physician's determination of the participant's psoriasis lesions overall at a given time point categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant's psoriasis is assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA (0,1) response was defined as a post-baseline sPGA score of 0 or 1 with at least a 2-point improvement from baseline in sPGA score.|Week 92|All randomized participants who received at least one dose of study drug. Non-Responders, as well as all participants who discontinue study treatment at any time prior to the time point of interest, were defined as Non-Responders for the NRI analysis.||Percent of Participants|||Number
686385|NCT01490632|Secondary|Percentage of Participants Achieving an sPGA of (0, 1) (Efficacy of Baricitinib in Participants With Moderate to Severe Plaque Psoriasis. Measure: Static Physician Global Assessment [sPGA])|The sPGA is a physician's determination of the participant's psoriasis lesions overall at a given time point categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant's psoriasis is assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA (0,1) response was defined as a post-baseline sPGA score of 0 or 1 with at least a 2-point improvement from baseline in sPGA score.|Week 24|All randomized participants who received at least one dose of study drug. Non-Responders, as well as all participants who discontinue study treatment at any time prior to the time point of interest, were defined as Non-Responders for the NRI analysis.||Percent of Participants|||Number
686397|NCT01490294|Secondary|Assessment of Contrast Quality of Delayed Enhancement (DE) at 15 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.|Delayed enhancement was measured at 15 minutes after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.||Participants|||Number
686479|NCT01489956|Secondary|Suppression (or Non-activation) of Cytokine Secretion Profile of T Cells Stimulated by KLH Following Oral Feeding (Part B)|No data available for analyses.|Day 42|Data were not collected and therefore no analyses could be performed.|||||
686386|NCT01490632|Secondary|Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) of (0, 1) (Efficacy of Baricitinib in Participants With Moderate to Severe Plaque Psoriasis. Measure: Static Physician Global Assessment [sPGA])|The sPGA is a physician's determination of the participant's psoriasis lesions overall at a given time point categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant's psoriasis is assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA (0,1) response was defined as a post-baseline sPGA score of 0 or 1 with at least a 2-point improvement from baseline in sPGA score.|Week 12|All randomized participants who received at least one dose of study drug. Non-Responders, as well as all participants who discontinue study treatment at any time prior to the time point of interest, were defined as Non-Responders for the NRI analysis.||Percent of Participants|||Number
686387|NCT01490632|Primary|Percentage of Participants Achieving Psoriasis Area and Severity Index Score ≥75% (PASI 75) Improvement (Efficacy of Baricitinib in Participants With Moderate to Severe Plaque Psoriasis. Measure: Psoriasis Area and Severity Index [PASI])|The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema (redness), and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease.|Week 12|North American (NA) modified intent-to-treat (mITT) population: All NA randomized participants who received at least one dose of study drug. Non-responders and participants who discontinued study drug any time prior to time point of interest, or discontinued from study, were defined as non-responders for the non-responder imputation (NRI) analysis.||Percent of Participants|||Number
686388|NCT01490294|Secondary|Percentage of Participants With Deviation of MRI Procedure (Clinical Evaluation)||Immediately within approximately 5 seconds after Gadobutrol bolus administration|All participants in FAS with assessment for this outcome measure. Evaluation included all participants in the full analysis population with an assessment for this outcome measure||Percentage of participants|||Number
686389|NCT01490294|Secondary|Percentage of Segments With Artifacts on Delayed Enhancement Images (Clinical Evaluation)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.|Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation included all participants in the per protocol population with an assessment for this outcome measure||Percent segmental assessment|Participants||Number
686390|NCT01490294|Secondary|Percentage of Segments With Artifacts on Delayed Enhancement Images (Blinded Reading)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.|Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration|PPS. Evaluation included all participants in the per protocol population with an assessment for this outcome measure||Percent segmental assessment|Participants||Number
686391|NCT01490294|Secondary|Percentage Agreement Between Gadobutrol Perfusion MRI Diagnosis (Clinical Evaluation) and Presence/Absence of Delayed Enhancement (DE) at the Time Point of Highest Agreement Between SPECT (Central Reading) and DE Based on Myocardial Regions|"Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Rest and stress perfusion MR and DE images were evaluated by the clinical investigator for absence/presence of scar on perfusion MR and presence/absence of DE on MR for 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA)."|Immediately within approximately 5 seconds after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation included all participants in the per protocol population with an assessment for this outcome measure.||Percent regional assessment|Participants||Number
686392|NCT01490294|Secondary|Percentage Agreement Between Gadobutrol Perfusion MRI Diagnosis (Clinical Evaluation) and the Presence/Absence of Delayed Enhancement (DE) at the Time Point of Highest Agreement Between SPECT (Central Reading) and DE Based on Myocardial Segments|"Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Rest and stress perfusion MR and DE images were evaluated by the clinical investigator for absence/presence of scar on perfusion MR and presence/absence of DE on MR for 16 myocardial segments (defined according to AHA)."|Immediately within approximately 5 seconds after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation included all participants in the per protocol population with an assessment for this outcome measure.||Percent segmental assessment|Participants||Number
686393|NCT01490294|Secondary|Percentage Agreement Between Gadobutrol Perfusion MRI Diagnosis (Blinded Reading) and the Presence/Absence of Delayed Enhancement (DE) at the Time Point of Highest Agreement Between SPECT (Central Reading) and DE Based on Myocardial Segments|"Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Rest and stress perfusion MR and DE images were evaluated by 3 blinded readers for absence/presence of scar on perfusion MR and presence/absence of DE on MR for 16 myocardial segments (defined according to AHA)."|Immediately within approximately 5 seconds after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation included all participants in the per protocol population with an assessment for this outcome measure.||Percent segmental assessment|Participants||Number
686394|NCT01490294|Secondary|Percent Agreement Between Gadobutrol Perfusion MRI Diagnosis (Blinded Reading) and the Presence/Absence of Delayed Enhancement (DE) at the Time Point of Highest Agreement Between SPECT (Central Reading) and DE Based on Myocardial Regions|"Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Rest and stress perfusion MR and DE images were evaluated by 3 blinded readers for absence/presence of scar on perfusion MR and presence/absence of DE on MR for 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA)."|Immediately within approximately 5 seconds after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation included all participants in the per protocol population with an assessment for this outcome measure.||Percent regional assessments|Participants||Number
686456|NCT01490190|Primary|Participants' Assessment of Ease of Insertion of Vaginal Ring|Participants were asked to classify their ability to insert the NuvaRing as very easy, easy, neutral, difficult, very difficult, or failed. The number of participants who responded to each category was reported.|Up to 84 days (three 28-day cycles)|Per Protocol Population, which included all participants who completed the study as per protocol.||Participants|||Number
686398|NCT01490294|Secondary|Assessment of Contrast Quality of Delayed Enhancement (DE) at 15 Minutes Post Injection According to Blinded Reading (Only Participants With DE in at Least One Segment, PPS)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Assessments of participants and/or segments by the individual blinded readers could differ. For the average reader, the results of the 3 individual readers are summarized.|Delayed enhancement was measured at 15 minutes after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.||Delayed enhancement assessments|Participants||Number
686399|NCT01490294|Secondary|Assessment of Contrast Quality of Delayed Enhancement (DE) at 10 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.|Delayed enhancement was measured at 10 minutes after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment||Participants|||Number
686400|NCT01490294|Secondary|Assessment of Contrast Quality of Delayed Enhancement (DE) at 10 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Assessments of participants and/or segments by the individual blinded readers could differ. For the average reader, the results of the 3 individual readers are summarized.|Delayed enhancement was measured at 10 minutes after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.||Delayed enhancement assessments|Participants||Number
686401|NCT01490294|Secondary|Assessment of Contrast Quality of Delayed Enhancement (DE) at 5 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.|Delayed enhancement was measured at 5 minutes after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.||Participants|||Number
686402|NCT01490294|Secondary|Assessment of Contrast Quality of Delayed Enhancement (DE) at 5 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Assessments of participants and/or segments by the individual blinded readers could differ. For the average reader, the results of the 3 individual readers are summarized.|Delayed enhancement was measured at 5 minutes after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.||Delayed enhancement assessments|Participants||Number
686403|NCT01490294|Secondary|Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 20 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.|Delayed enhancement was measured at 20 minutes after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.||Participants|||Number
686404|NCT01490294|Secondary|Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 20 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Assessments of participants and/or segments by the individual blinded readers could differ. For the average reader, the results of the 3 individual readers are summarized.|Delayed enhancement was measured at 20 minutes after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.||Delayed enhancement assessments|Participants||Number
686405|NCT01490294|Secondary|Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 15 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.|Delayed enhancement was measured at 15 minutes after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.||Participants|||Number
686406|NCT01490294|Secondary|Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 15 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Assessments of participants and/or segments by the individual blinded readers could differ. For the average reader, the results of the 3 individual readers are summarized.|Delayed enhancement was measured at 15 minutes after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.||Delayed enhancement assessments|Participants||Number
686407|NCT01490294|Secondary|Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 10 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.|Delayed enhancement was measured at 10 minutes after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.||Participants|||Number
686408|NCT01490294|Secondary|Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 10 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Assessments of participants and/or segments by the individual blinded readers could differ. For the average reader, the results of the 3 individual readers are summarized|Delayed enhancement was measured at 10 minutes after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.||Delayed enhancement assessments|Participants||Number
686409|NCT01490294|Secondary|Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 5 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.|Delayed enhancement was measured at 5 minutes after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.||Participants|||Number
686410|NCT01490294|Secondary|Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 5 Minutes Post Injection (Blinded Reading)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Results are displayed on a per patient basis.|Delayed enhancement was measured at 5 minutes after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. The evaluation included only participants with delayed enhancement in at least 1 segment ( PPS) based on the assessment of at least one blinded reader.||Delayed enhancement assessments|Participants||Number
686411|NCT01490294|Secondary|Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Clinical Evaluation) and Scar in SPECT (Central Reading) Based on Myocardial Segments|"Delayed enhancement (DE)-[accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions]- MR images acquired at different time points were evaluated by the respective investigator regarding the presence/absence of delayed enhancement at 5 - 20 minutes post injection in 16 myocardial segments (defined according to the American Heart Association). DE data were compared to the diagnosis scar derived from SPECT. The number of segmental assessments is defined as the number of segments with diagnosis scar assessed by the investigator."|Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration|"All participants in PPS with assessment for this outcome measure. Only participants with the finding scar in at least 1 segment in SPECT were included."||Percent segmental assessment|Participants||Number
686412|NCT01490294|Secondary|Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Clinical Evaluation) and Scar in SPECT (Central Reading) Based on Myocardial Regions|"Delayed enhancement (DE) -[accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions]- MR images acquired at different time points, were evaluated by the clinical investigator for presence/absence of DE at 5 - 20 minutes post injection in 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). DE data were compared to the diagnosis scar derived from SPECT. The number of regional assessments is defined as the number of regions with diagnosis scar assessed by the investigator."|Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration|"All participants in PPS with assessment for this outcome measure. Only participants with the finding scar in at least 1 region in SPECT were included."||Percent regional assessments|Participants||Number
686413|NCT01490294|Secondary|Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Blinded Reading) and Scar in SPECT (Central Reading) Based on Myocardial Segments|"Delayed enhancement -[accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions]- MR images acquired at different time points were evaluated by 3 independent blinded readers regarding the presence/absence of DE at 5 - 20 minutes post injection in 16 myocardial segments (defined according to the American Heart Association). DE data were compared to the diagnosis scar derived from SPECT. The number of segmental assessments is defined as the number of segments with diagnosis scar assessed by at least 1 blinded reader."|Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration|"All participants in PPS with assessment for this outcome measure. Only participants with the finding scar in at least 1 segment in SPECT were included."||Percent segmental assessments|Participants||Number
686414|NCT01490294|Secondary|Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Blinded Reading) and Scar in SPECT (Central Reading) Based on Myocardial Regions|"Delayed enhancement (DE) -[accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions]- MR images acquired at different time points, were evaluated by 3 independent blinded readers for presence/absence of DE at 5 - 20 minutes post injection in 3 myocardial regions representing the 3 arterial territories of the heart. DE data were compared to the diagnosis scar derived from SPECT. The number of regional assessments is defined as the number of regions with diagnosis scar assessed by at least 1 blinded reader."|Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration|"All participants in PPS with assessment for this outcome measure. Only participants with the finding scar in at least 1 segment in SPECT were included."||Percent regional assessments|Participants||Number
686415|NCT01490294|Secondary|Time to Peak Based on Segments|"Time to peak is defined as the time in seconds from start to maximum signal intensity (SI max) on the SI curve and was evaluated for normal and for diseased (i.e. ischemia/scar/mixed) segments in order to assess a potential difference (normal/diseased was defined by central reading of SPECT)."|Immediately within approximately 5 seconds after Gadobutrol bolus administration up to 2 minutes|PPS||Seconds||Standard Deviation|Mean
686416|NCT01490294|Secondary|Upslope Based on Segments|"Upslope is defined as the maximum slope of the signal intensity (SI) increase on the SI/time curve (determined by a linear fit) during 3 consecutive heart beats reported in Units/sec. The upslope was evaluated for normal and for diseased (i.e. ischemia/scar/mixed) segments in order to assess a potential difference (normal/diseased was defined by central reading of SPECT)."|Immediately within approximately 5 seconds after Gadobutrol bolus administration|PPS||Units/sec||Standard Deviation|Mean
686417|NCT01490294|Secondary|Signal Intensity (SIrel) Based on Segments|"The signal intensity (SIrel) is determined over time. SI (SIrel) is the upslope in myocardium divided by upslope of the ventricle, as assessed for normal and underperfused segments. SI(rel) = upslope myocard / upslope ventricle. MR segments were evaluated for signal intensity (SIrel) in order to assess if a difference between normal and diseased (i.e. ischemia/scar/mixed) segments could be demonstrated (normal/diseased was defined by central reading of SPECT)."|Immediately within approximately 5 seconds after Gadobutrol bolus administration|PPS||Signal intensity||Standard Deviation|Mean
686457|NCT01490190|Primary|Number of Spotting Days Per Cycle|Intermenstrual vaginal bleeding that required <=1 pad per day was classified as SPOTTING.|Up to 84 days (three 28-day cycles)|Participants in the Per Protocol Population who experienced spotting were evaluated for duration of spotting.||Days||Standard Deviation|Mean
686418|NCT01490294|Secondary|Percentage Agreement Between the Visual (Blinded Reading) and Semiquantitative (MPRI; Expert Evaluation) Gadobutrol Perfusion MRI Diagnosis Based on Myocardial Segments|Rest and stress perfusion MR images were visually evaluated by 3 blinded readers. The MPRI was calculated by an independent MR expert. Analysis was performed for 16 myocardial segments (defined according to the American Heart Association). Visual and semiquantitative data were compared to each other per segment. The number of segmental assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial segments.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|PPS||Percent segmental assessments|Participants||Number
686419|NCT01490294|Secondary|Percentage Agreement Between the Visual (Blinded Reading) and the Semiquantitative (MPRI; Expert Evaluation) Gadobutrol Perfusion MRI Diagnosis Based on Myocardial Regions|Rest and stress perfusion MR images were visually evaluated by 3 blinded readers. The MPRI was calculated by an independent MR expert. Analysis was performed for 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA): Visual and semiquantitative data were compared to each other per region. The number of regional assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial regions.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|PPS||Percent regional assessments|Participants||Number
686420|NCT01490294|Secondary|"Percentage Agreement Between the Semiquantitative Gadobutrol Perfusion MRI Parameter Myocardial Perfusion Reserve Index (MPRI) (Expert Evaluation) and SPECT (Central Reading) Based on Myocardial Segments"|MPRI was calculated as decribed in outcome measure 22 on stress and rest perfusion MR images by an independent MR expert for 16 myocardial segments (defined according to the American Heart Association). MPRIs <= 1.5 (perfusion defect) and >1.5 (normal) were then compared to presence/absence of perfusion defects in the segmental data from SPECT. The number of segmental assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial segments.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|PPS||Percent segmental assessments|Participants||Number
686421|NCT01490294|Secondary|"Percentage Agreement Between the Semiquantitative Gadobutrol Perfusion MRI Parameter Myocardial Perfusion Reserve Index (MPRI) (Expert Evaluation) and SPECT (Central Reading) Based on Myocardial Regions"|MPRI was calculated as decribed in outcome measure 22 on stress and rest perfusion MR images by an independent MR expert for 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). MPRIs <= 1.5 (perfusion defect) and >1.5 (normal) were compared to presence/absence of perfusion defects in the regional data analysis from SPECT. The number of regional assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial regions.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|PPS||Percent regional assessments|Participants||Number
686422|NCT01490294|Secondary|Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and the Truth Panel Diagnosis (SoT) Regarding Perfusion Defects Based on Regions|For patients undergoing coronary angiography additionally to SPECT, a Truth Panel with 2 cardiology experts was employed as SoT to come to a consensus diagnosis. Rest and stress MR images were evaluated by 3 independent blinded readers for presence/absence of perfusion defects in 3 myocardial regions representing the 3 arterial territories/arteries of the heart. These data were compared to the SoT diagnosis. The number of regional assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial regions.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure||Percent regional assessments|Participants||Number
686423|NCT01490294|Secondary|"Percentage Agreement Between the Semiquantitative Gadobutrol Perfusion MRI Parameter Myocardial Perfusion Reserve Index (MPRI)  (Expert Evaluation) and Detection of Significant Stenoses by Coronary Angiography (MR Based on Myocardial Regions)"|MPRI was calculated for the upslope of the signal intensity /time curve on stress and rest perfusion MR images by an independent MR expert for 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). The upslope-value at post-stress was divided by the value at rest. MPRI <=1.5 (perfusion defect) and >1.5 (normal) were compared to coronary angiography regarding presence/absence of significant coronary artery stenosis of >70%. The number of regional assessments was calculated by multiplication of the number of participants with the number of the myocardial regions.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure||Percent regional assessments|Participants||Number
686424|NCT01490294|Secondary|Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading, Based on Myocardial Regions) and Coronary Angiography (Central Reading) Regarding Detection of Significant Stenoses|Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for presence/absence of perfusion deficits in 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). These data were compared to coronary angiography regarding presence/absence of significant coronary artery stenosis of > 70%. The number of regional assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial regions.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure||Percent regional assessments|Participants||Number
686425|NCT01490294|Secondary|Percentage of Artifacts in Gadobutrol Perfusion MRI (Clinical Evaluation) Based on Myocardial Segments|Rest and stress MR images were evaluated by the investigator regarding the presence/absence of artifacts in 16 myocardial segments (defined according to the American Heart Association). The number of segments with artifacts was calculated by multiplication of the number of participants with the number of the myocardial segments.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|PPS||Percentage of segments with artifacts|Participants||Number
686426|NCT01490294|Secondary|Percentage of Artifacts in Gadobutrol Perfusion MRI (Blinded Reading) Based on Myocardial Segments|Rest and stress MR images were evaluated by 3 independent blinded readers regarding the presence/absence of artifacts in 16 myocardial segments (according to the American Heart Association). The number of segmental assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of myocardial segments.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|PPS||Percentage of segments with artifacts|Participants||Number
686427|NCT01490294|Secondary|Percent Agreement Between Combined Gadobutrol Perfusion MRI (Perfusion Imaging and Delayed (DE) Imaging; Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Perfusion Deficits Based on Myocardial Segments|Rest and stress perfusion and DE MR images were evaluated by 3 independent blinded readers regarding the detailed characterization of cardiac perfusion deficits i.e scar, ischemia or a mixture of both in 16 myocardial segments (defined according to the American Heart Association). MR data were compared to the corresponding segmental data derived from SPECT. The number of segmental assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of myocardial segments.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|PPS||Percent segmental assessments|Participants||Number
686428|NCT01490294|Secondary|Percent Agreement Between Combined Gadobutrol Perfusion MRI (Perfusion Imaging and Delayed (DE) Imaging; Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Perfusion Deficits Based on Myocardial Regions|Rest and stress perfusion and DE MR images were evaluated by 3 independent blinded readers regarding the detailed characterization of cardiac perfusion deficits i.e scar, ischemia or a mixture of both, in 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). MR data were compared to the corresponding regional data from SPECT. The number of regional assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial regions.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|PPS||Percent regional assessments|Participants||Number
686429|NCT01490294|Secondary|Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both Based on Myocardial Segments|Rest and stress perfusion MR images were evaluated by the respective clinical investigator for detailed characterization of cardiac perfusion deficits i.e. scar, ischemia or a mixture of both in 16 myocardial segments (defined according to the American Heart Association).MR data were compared to the corresponding segmental data from SPECT. The number of segmental assessments was calculated by multiplication of the number of participants with the number of the myocardial segments.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|PPS||Percent segmental assessments|Participants||Number
686430|NCT01490294|Secondary|Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both Based on Myocardial Regions|Rest and stress perfusion MR images were evaluated by the respective clinical investigator for detailed characterization of cardiac perfusion deficits i.e. scar, ischemia or mixture of both in 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). MR data were compared to the corresponding regional data from SPECT. The number of regional assessments was calculated by multiplication of the number of participants with the number of the myocardial regions.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|PPS||Percent regional assessments|Participants||Number
686431|NCT01490294|Secondary|Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both Based on Myocardial Segments|Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for detailed characterization of cardiac perfusion deficits i.e. scar, ischemia or mixture of both in 16 myocardial segments (defined according to the American Heart Association). MR data were compared to the corresponding segmental data from SPECT. The number of segmental assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial segments.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|PPS||Percent segmental assessment|Participants||Number
686432|NCT01490294|Secondary|Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both, Based on Myocardial Regions|Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for detailed characterization of cardiac perfusion deficits i.e. scar, ischemia or mixture of both in 3 myocardial regions representing 3 coronary territories/arteries (LAD, LCX, RCA). MR data were compared to the corresponding regional data from SPECT. The number of regional assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial regions.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|PPS||Percent regional assessments|Participants||Number
686433|NCT01490294|Secondary|"Diagnosis Ischemia: Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Segments"|"Rest and stress perfusion MR images were evaluated by the respective clinical investigator for presence/absence and characterization of cardiac perfusion deficits as ischemia in 16 myocardial segments (defined according to the American Heart Association). These data were compared to corresponding segmental SPECT diagnosis of ischemia. The number of segmental assessments is defined as the number of segments with diagnosis ischemia assessed by the investigator."|Immediately within approximately 5 seconds after Gadobutrol bolus administration|"All participants in PPS with assessment for this outcome measure. Only patients with the finding ischemia in at least 1 segment in SPECT were included."||Percent segmental assessments|Participants||Number
686434|NCT01490294|Secondary|"Diagnosis Ischemia: Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Regions"|"Rest and stress perfusion MR images were evaluated by the respective clinical investigator for presence/absence and characterization of cardiac perfusion deficits as ischemia in the 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). These data were compared to the corresponding regional SPECT diagnosis of ischemia. The number of regional assessments is defined as the number of regions with diagnosis ischemia assessed by the investigator."|Immediately within approximately 5 seconds after Gadobutrol bolus administration|"All participants in PPS with assessment for this outcome measure. Only patients with the finding ischemia in at least 1 region in SPECT were included."||Percent regional assessments|Participants||Number
686458|NCT01490190|Primary|Number of Bleeding Days Per Cycle|Intermenstrual vaginal bleeding that required >=2 pads per day was classified as BLEEDING.|Up to 84 days (three 28-day cycles)|One participant in Per Protocol Population who experienced vaginal bleeding was evaluated for duration of bleeding.||Days||Standard Deviation|Mean
686435|NCT01490294|Secondary|"Diagnosis Ischemia: Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Segments"|"Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for presence/absence and characterization of cardiac perfusion deficits as ischemia in 16 myocardial segments (defined according to the American Heart Association). These data were compared to corresponding segmental SPECT diagnosis of ischemia. The number of segmental assessments is defined as the number of segments with diagnosis ischemia assessed by at least 1 blinded reader."|Immediately within approximately 5 seconds after Gadobutrol bolus administration|"All participants in PPS with assessment for this outcome measure. Only patients with the finding ischemia in at least 1 segment in SPECT were included."||Percent segmental assessment|Participants||Number
686436|NCT01490294|Secondary|"Diagnosis Ischemia: Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Regions"|"Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for presence/absence and characterization of cardiac perfusion deficits as ischemia in the 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). These data were compared to the corresponding regional SPECT diagnosis of ischemia.The number of regional assessments is defined as the number of regions with diagnosis ischemia assessed by at least 1 blinded reader."|Immediately within approximately 5 seconds after Gadobutrol bolus administration|"All participants in PPS with assessment for this outcome measure. Only patients with the finding ischemia in at least 1 region in SPECT were included."||Percent regional assessments|Participants||Number
686437|NCT01490294|Secondary|"Diagnosis Scar: Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis Scar Based on Myocardial Segments"|"Rest and stress perfusion MR images were evaluated by the respective clinical investigator for presence/absence and characterization of cardiac perfusion deficits as scar in 16 myocardial segments (defined according to the American Heart Association). These data were compared to the corresponding segmental SPECT diagnosis of scar. The number of segmental assessments is defined as the number of segments with diagnosis scar assessed by the investigator."|Immediately within approximately 5 seconds after Gadobutrol bolus administration|"All participants in PPS with assessment for this outcome measure. Only patients with the finding scar in at least 1 segment in SPECT were included."||Percent segmental assessments|Participants||Number
686438|NCT01490294|Secondary|"Diagnosis Scar: Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis Scar Based on Myocardial Regions"|"Rest and stress perfusion MR images were evaluated by the respective clinical investigator for presence/absence and characterization of cardiac perfusion deficits as scar in the 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). These data were compared to the corresponding regional SPECT diagnosis of scar. The number of regional assessments is defined as the number of segments with diagnosis scar assessed by the investigator."|Immediately within approximately 5 seconds after Gadobutrol bolus administration|"All participants in PPS with assessment for this outcome measure. Only patients with the finding scar in at least 1 region in SPECT were included."||Percent regional assessments|Participants||Number
686439|NCT01490294|Secondary|"Diagnosis Scar: Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis Scar Based on Myocardial Segments"|"Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for presence/absence and characterization of cardiac perfusion deficits as scar in 16 myocardial segments (defined according to the American Heart Association). These data were compared to corresponding segmental SPECT diagnosis of scar. The number of segmental assessments is defined as the number of segments with diagnosis scar assessed by at least 1 blinded reader."|Immediately within approximately 5 seconds after Gadobutrol bolus administration|"All participants in PPS with assessment for this outcome measure. Only patients with the finding scar in at least 1 segment in SPECT were included."||Percent segmental assessments|Participants||Number
686440|NCT01490294|Secondary|Diagnosis 'Scar': Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis Scar Based on Myocardial Regions|"Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for presence/absence and characterization of cardiac perfusion deficits as scar in the 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). These data were compared to the corresponding regional SPECT diagnosis of 'scar'. The number of regional assessments is defined as the number of regions with diagnosis 'scar' assessed by at least 1 blinded reader."|Immediately within approximately 5 seconds after Gadobutrol bolus administration|"All participants in PPS with assessment for this outcome measure. Only patients with the finding scar in at least 1 region in SPECT were included."||Percent regional assessments|Participants||Number
686441|NCT01490294|Secondary|Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Segments|Rest and stress perfusion MR images were evaluated by the respective investigator for presence/absence of cardiac perfusion deficits in 16 myocardial segments (defined according to the American Heart Association). These data were compared to the corresponding segmental data from SPECT. The number of segmental assessments was calculated by multiplication of the number of participants with the number of the myocardial segments.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|PPS||Percent segmental assessments|Participants||Number
686442|NCT01490294|Secondary|Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Regions|Rest and stress perfusion MR images were evaluated by the respective clinical investigator for presence/absence of cardiac perfusion deficits in 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). These data were compared to the corresponding regional data from SPECT. The number of regional assessments was calculated by multiplication of the number of participants with the number of the myocardial regions.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|PPS||Percent regional assessments|Participants||Number
686480|NCT01489956|Secondary|T Cell Stimulation Index Measured by Carboxyfluorescein Diacetate Succinimidyl Ester (CFSE) Staining After KLH Stimulation (Part A)|No data available for analyses.|Days 0, 9, 16|Data were not collected and therefore no analyses could be performed.|||||
686443|NCT01490294|Primary|Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Segments|Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for presence/absence of cardiac perfusion deficits in 16 myocardial segments (defined according to the American Heart Association). These data were compared to the corresponding segmental data from SPECT. The number of segmental assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial segments.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|Per protocol set (PPS)||Percent segmental assessment|Participants||Number
686444|NCT01490294|Primary|Percentage Agreement Between Gadobutrol Perfusion Magnetic Resonance Imaging (MRI) (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Regions|Rest and stress perfusion Magnetic Resonance (MR) images were evaluated by 3 independent blinded readers for presence/absence of cardiac perfusion deficits in 3 myocardial regions representing the 3 coronary territories/arteries (left anterior decendent [LAD], left circumflex [LCX], right coronary artery [RCA]). Data were compared to the corresponding regional data from Single Photon Emission Computer Tomography (SPECT). The number of regional assessments was calculated by multiplication of the number of participants with the number of the blinded readers and number of the myocardial regions.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|Per protocol set (PPS)||Percent regional assessments|Participants||Number
686445|NCT01490190|Secondary|Number of Participants Who Reported a Serious Adverse Event During the Study|A serious adverse event is any adverse drug or biologic or device experience that results in death, a life-threatening adverse event, persistent or significant disability or incapacity; requires in-patient hospitalization, or prolonged hospitalization; or causes a congenital anomaly or birth defect.|Up to 84 days (three 28-day cycles)|Safety Population, which included all participants who met inclusion and exclusion criteria and who inserted NuvaRing at least once during the study period.||Participants|||Number
686446|NCT01490190|Secondary|Number of Participants Who Reported at Least One Adverse Event During the Study|An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic, or medical device, which does not necessarily have a causal relationship with the treatment.|Up to 84 days (three 28-day cycles)|Safety Population, which included all participants who met inclusion and exclusion criteria and who inserted NuvaRing at least once during the study period.||Participants|||Number
686447|NCT01490190|Secondary|Number of Pregnancies Due to Contraceptive Method Failure During the Study|For participants with suspected pregnancy during in-treatment period, pregnancy was to be confirmed by hCG qualitative analysis using strip and/or other test(s) at the discretion of the treating physician.|Up to 84 days (three 28-day cycles)|Safety Population, which included all participants who met inclusion and exclusion criteria and who inserted NuvaRing at least once during the study period.||Pregnancies|||Number
686448|NCT01490190|Primary|Number of Participants Who Would Recommend Vaginal Ring to Others|Participants were asked at follow-up visits after every cycle whether they would recommend NuvaRing to other women, and their answers were reported.|Up to 84 days (three 28-day cycles)|Safety Population, which included all participants who met inclusion and exclusion criteria and who inserted NuvaRing at least once during the study period.||Participants|||Number
686449|NCT01490190|Primary|Number of Participants Who Plan to Continue Using Vaginal Ring|Participants were asked at follow-up visits after every cycle whether they planned to continue using NuvaRing, and their answers were recorded.|Up to 84 days (three 28-day cycles)|Safety Population, which included all participants who met inclusion and exclusion criteria and who inserted NuvaRing at least once during the study period.||Participants|||Number
686450|NCT01490190|Primary|Participants' Overall Satisfaction With Vaginal Ring|Participants were asked to characterize their overall satisfaction with the NuvaRing as one of the following: very satisfied, satisfied, neutral, unsatisfied, or very unsatisfied. The number of participants who responded to each category was reported.|Up to 84 days (three 28-day cycles)|Safety Population, which included all participants who met inclusion and exclusion criteria and who inserted NuvaRing at least once during the study period.||Participants|||Number
686451|NCT01490190|Primary|Frequency of Partner Objecting to Vaginal Ring Use|Participants were asked if their partners objected to their using the NuvaRing during intercourse and to characterize the frequency of their partners' objections as one of the following: never, rarely, occasionally, mostly, or always. The number of participants who responded to each category was reported.|Up to 84 days (three 28-day cycles)|Per Protocol Population, which included all participants who completed the study as per protocol.||Participants|||Number
686452|NCT01490190|Primary|Frequency of Partner Feeling Vaginal Ring During Intercourse|Participants were asked if their partners could feel the NuvaRing during intercourse and to characterize their partners' experience as one of the following: never, rarely, occasionally, mostly, or always. The number of participants who responded to each category was reported.|Up to 84 days (three 28-day cycles)|Per Protocol Population, which included all participants who completed the study as per protocol.||Participants|||Number
686453|NCT01490190|Primary|Participants' Assessment of Feeling Vaginal Ring During Intercourse|Participants were asked to assess whether they could feel the NuvaRing during intercourse and to characterize how often as one the following: never, rarely, occasionally, mostly, or always. The number of participants who responded to each category was reported.|Up to 84 days (three 28-day cycles)|Per Protocol Population, which included all participants who completed the study as per protocol.||Participants|||Number
686454|NCT01490190|Primary|Participants' Assessment of Feeling Vaginal Ring at Any Time|Participants were asked to assess whether they could feel the NuvaRing at any time and to characterize how often as one of the following: never, rarely, occasionally, mostly, or always. The number of participants who responded to each category was reported.|Up to 84 days (three 28-day cycles)|Per Protocol Population, which included all participants who completed the study as per protocol.||Participants|||Number
686455|NCT01490190|Primary|Participants' Assessment of Ease of Removal of Vaginal Ring|Participants were asked to classify their ability to remove the NuvaRing as very easy, easy, neutral, difficult, very difficult, or failed. The number of participants who responded to each category was reported.|Up to 84 days (three 28-day cycles)|Per Protocol Population, which included all participants who completed the study as per protocol.||Participants|||Number
686460|NCT01490190|Primary|Average Number of Pads Used Per Day, Per Cycle, During Menstruation While Using Ring|Intensity of menstruation, as indicated by the median number of pads used per day by participants during each cycle of NuvaRing use.|Up to 84 days (three 28-day cycles)|Per Protocol Population, which included all participants who completed the study as per protocol. Of the total Per Protocol Population (N = 204), data for this outcome measure were missing for 3 partcipants in the first cycle, 1 participant in the second cycle, and 1 participant in the third cycle.||Pads||Full Range|Median
686461|NCT01490190|Primary|Average Number of Bleeding Days Per Cycle|Mean duration of menstruation, per day, per cycle, during the study period.|Up to 84 days (three 28-day cycles)|Per Protocol Population, which included all participants who completed the study as per protocol. Of the total Per Protocol Population (N = 204), data for this outcome measure were missing for 3 partcipants in the first cycle, 1 participant in the second cycle, and 1 participant in the third cycle.||Days||Standard Deviation|Mean
686462|NCT01490190|Primary|Number of Participants With Regular Menstrual Cycles|The number of participants who experienced regular menstrual bleeding patterns throughout the period of NuvaRing use. Bleeding patterns were to be characterized by particpants as regular or irregular.|Up to 84 days (three 28-day cycles)|Per Protocol Population, which included all participants who completed the study as per protocol.||Participants|||Number
686463|NCT01490151|Primary|Safety and Feasibility of TTR Closed-loop Control System as Measure by the Count of Successful Hospital Admissions|A successful hospital admission was defined as requiring no more than 2 TTR closed-loop control system adjustments of algorithm tuning parameters after initial set up, and not meeting any stopping criteria. The system was considered feasible if 75% of hospital admissions were successful.|Day of hospital admission (12 hours)|A total of 25 admissions were completed. 1 participant was admitted twice in Cohort A1, and 2 participants were admitted first in Cohort A1 and then again in Cohort B.||Admissions|Admissions||Count of Units
686464|NCT01490125|Secondary|Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication Used Over the 6 Weeks of Treatment|The number of puffs of rescue medication taken by participants, were collected each day during the study via entries in e-diaries|Baseline and 6 weeks|The analysis set includes all randomized patients who received at least one dose of study drug and for whom data are available. Data was analyzed according to the treatment they were randomized. In this cross-over design the number of patients on each treatment does not add up to the total number of patients.||puffs||Standard Deviation|Least Squares Mean
686465|NCT01490125|Secondary|Change From Baseline in The Capacity of Daily Living During the Morning (CDLM) Score Averaged Over 6 Weeks of Treatment|The Capacity of Daily Living during the Morning (CDLM) is a self-administered daily assessment. The CDLM asks COPD patients to (i) report their ability to carry out 6 morning activities and (ii) rate the difficulty in performing those activities on a five point Likert-type scale ranging from “not at all difficult” to “extremely difficult”. For each of the six morning activities a score ranging from 0 (=so difficult that they could not carry out the activity by themselves) to 5 (not at all difficult to carry out the activity by themselves) is calculated by using the responses from the two questions for each activity. Daily CDLM is calculated using the scores average from the 6 morning activities. CDLM is calculated as the average daily CDLM score over 6 weeks of treatment. The change from baseline in CDLM score over 6 weeks is analyzed using a MIXED model with baseline CDLM score as a covariate. A CDLM score of 0.20 is considered to be a minimal clinically important difference.|Baseline and 6 weeks|The analysis set includes all randomized patients who received at least one dose of study drug and for whom data are available. Data was analyzed according to the treatment they were randomized. In this cross-over design the number of patients on each treatment does not add up to the total number of patients.||Units on a scale||Standard Error|Least Squares Mean
686466|NCT01490125|Secondary|Standardized Forced Vital Capacity (FVC) Area Under the Curve (AUC) 5min-4 Hrs After First Dose and 6 Weeks of Treatment With QVA149 Compared to Placebo and Tiotropium|Forced Vital Capacity (FVC) is the total amount of air that can be exhaled by the patient after a full inhalation. The FVC was measured via spirometry conducted according to internationally accepted standards at 5 min-4 hr post dose of day 1 and week 6.|5min-4hr at day 1 and week 6 post-dose|The analysis set includes all randomized patients who received at least one dose of study drug and for whom data are available. Data was analyzed according to the treatment they were randomized. In this cross-over design the number of patients on each treatment does not add up to the total number of patients.||Liters||Standard Error|Least Squares Mean
686467|NCT01490125|Secondary|Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) 5min-4h After First Dose and 6 Weeks of Treatment With QVA149 Compared to Placebo and Tiotropium|Forced Expiratory Volume in 1 second (FEV1) was measured with spirometry conducted according to internationally accepted standards. Measurements were taken at 5 min- 4hr post-dose of day 1 and week 6. The standardized FEV1 Area under the curve (AUC) was calculated as the sum of trapezoids divided by the length of time.|5min-4hr at day 1 and week 6 post-dose|The analysis set includes all randomized patients who received at least one dose of study drug and for whom data are available. Data was analyzed according to the treatment they were randomized. In this cross-over design the number of patients on each treatment does not add up to the total number of patients.||Liters||Standard Error|Least Squares Mean
686468|NCT01490125|Secondary|Total Total Transient Dyspnea Index (TDI) Score After 6 Weeks of Treatment QVA149 Compared to Tiotropium|Total Transient Dyspnea Index (TDI) is part of the BDI/TDI questionnaire where participants indicated whether they improved or deteriorated since their Baseline Dyspnea Index (BDI). The BDI and TDI each had 3 domains: activities, tasks, and effort. BDI domains were rated from 0 (very severe) to 4 (none) and the rates summed for the total BDI score ranging from 0 to 12; the lower the score the worse the severity of dyspnea. TDI domains were rated from -6 (major deterioration) to 6 (major improvement) and the rates summed for the total TDI score ranging from -18 to 18. However, to ensure comparability with the TDI paper version, all TDI values were divided by 2 before the analysis. If data was missing or insufficient for any one of the domains a BDI/TDI was calculated. BDI = Baseline Dyspnea Index taken 75 min prior to the first dose in each treatment period. TDI = Transition Dyspnea Index taken after 6 weeks of treatment 75 min prior to the last dose in each treatment period.|Baseline and 6 weeks|The analysis set includes all randomized patients who received at least one dose of study drug and for whom data are available. Data was analyzed according to the treatment they were randomized. In this cross-over design the number of patients on each treatment does not add up to the total number of patients.||Units on a scale||Standard Deviation|Mean
686469|NCT01490125|Primary|Total Total Transient Dyspnea Index (TDI) Score After 6 Weeks of Treatment QVA149 Compared to Placebo|Total Transient Dyspnea Index (TDI) is part of the BDI/TDI questionnaire where participants indicated whether they improved or deteriorated since their Baseline Dyspnea Index (BDI). The BDI and TDI each had 3 domains: activities, tasks, and effort. BDI domains were rated from 0 (very severe) to 4 (none) and the rates summed for the total BDI score ranging from 0 to 12; the lower the score the worse the severity of dyspnea. TDI domains were rated from -6 (major deterioration) to 6 (major improvement) and the rates summed for the total TDI score ranging from -18 to 18. However, to ensure comparability with the TDI paper version, all TDI values were divided by 2 before the analysis. If data was missing or insufficient for any one of the domains a BDI/TDI was calculated. BDI = Baseline Dyspnea Index taken 75 min prior to the first dose in each treatment period. TDI = Transition Dyspnea Index taken after 6 weeks of treatment 75 min prior to the last dose in each treatment period.|Baseline and 6 weeks|The analysis set includes all randomized patients who received at least one dose of study drug and for whom data are available. Data was analyzed according to the treatment they were randomized. In this cross-over design the number of patients on each treatment does not add up to the total number of patients.||Units on a scale||Standard Deviation|Mean
686470|NCT01490086|Secondary|Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS General Psychopathology Subscale|The General Psychopathology Scale consists of 16 items (Somatic concern, Anxiety, Guilt feelings, Tension, Mannerisms and posturing, Depression, Motor retardation, Uncooperativeness, Unusual thought content, Disorientation, Poor attention, Lack of judgment and insight, Disturbance of volition, Poor impulse control, Preoccupation, Active social avoidance). The General Psychopathology score is obtained by adding the ratings of each item in the scale, with results ranging from 16 to 112. A higher score reflects worse outcome and a larger reduction in the score from baseline reflects better treatment efficacy.|Baseline to Day 28|The ITT population is comprised of participants who had received at least one dose of treatment, have baseline and at least one assessment of PANSS and CGI-S without major deviations at baseline.||scores on a scale||Standard Deviation|Mean
686471|NCT01490086|Secondary|Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS Negative Subscale|The Negative Scale includes 7 items (Blunted affect, Emotional withdrawal, Poor rapport, Passive/apathetic social withdrawal, Difficulty in abstract thinking, Lack of spontaneity and flow of conversation, Stereotyped thinking) and is calculated by adding the negative subscale item scores to obtain results ranging from 7 to 49. Minimum score is 7, maximum score is 49. A higher score reflects worse outcome and a larger reduction in the score from baseline reflects better treatment efficacy.|Baseline to Day 28|The ITT population is comprised of participants who had receiving at least one dose of treatment, have baseline and at least one assessment of PANSS and CGI-S without major deviations at baseline.||scores on a scale||Standard Deviation|Mean
686472|NCT01490086|Secondary|Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS Positive Subscale|The Positive Scale includes 7 Items (Delusions, Conceptual disorganization, Hallucinations, Hyperactivity, Grandiosity, Suspiciousness/persecution, Hostility) and is calculated by adding the subscale item scores to obtain results ranging from 7 to 49. A higher score reflects worse outcome and a larger reduction in the score from baseline reflects better treatment efficacy.|Baseline to Day 28|The ITT population is comprised of participants who had received at least one dose of treatment, have baseline and at least one assessment of PANSS and CGI-S without major deviations at baseline.||scores on a scale||Standard Deviation|Mean
686473|NCT01490086|Secondary|Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the Clinical Global Impression Scale – Severity (CGI-S)|Clinical Global Impression, Severity (CGI-S) is a single-item (7-point) scale that evaluates the overall severity of the subject's mental illness. Scores range from 1 (not ill at all) to 7 (among the most extremely ill). A reduction in score indicates an improvement in the subject's condition.|Baseline to Day 28|The ITT population is comprised of participants who had received at least one dose of treatment, have baseline and at least one assessment of PANSS and CGI-S without major deviations at baseline.||scores on a scale||Standard Deviation|Mean
686474|NCT01490086|Primary|Measurement of Schizophrenia Symptoms: Positive and Negative Syndrome Scale (PANSS) Total Score|PANSS total score comprises Positive (Delusions, Conceptual disorganization, Hallucinatory behavior, Excitement, Grandiosity, Suspiciousness/persecution, Hostility), Negative (Blunted affect, Emotional withdrawal, Poor rapport, Passive/apathetic social withdrawal, Difficulty in abstract thinking, Lack of spontaneity and flow of conversation, Stereotyped thinking), and General Psychopathology (Somatic concern, Anxiety, Guilt feelings, Tension, Mannerisms and posturing, Depression, Motor retardation, Uncooperativeness, Unusual thought content, Disorientation, Poor attention, Lack of judgment and insight, Disturbance of volition, Poor impulse control, Preoccupation, Active social avoidance) Scales. Scores are obtained by adding the ratings of each item in each scale. Range is 7-49 for Positive and Negative scores; 16-112 for General Psychopathology score; and 30-210 for Total score. Higher score reflects worse outcome; larger reduction from baseline reflects better outcome.|Baseline to Day 28|The ITT population is comprised of participants who had received at least one dose of treatment, have baseline and at least one assessment of PANSS and CGI-S without major deviations at baseline.||scores on a scale||Standard Deviation|Mean
686475|NCT01490060|Primary|Complete Response|Complete response (CR) defined as: No emetic episodes and no rescue medications. This is a cross-over designed study, the outcomes by single dose, two doses and control cycles were evaluated by combining the results from both cycle 1 and cycle 2 according to the treatment received.|From Day 1 to Day 5 in two 21-days cycles (Cycle 1 and Cycle 2).|Out of 40 eligible participants, 2 participants had change of treatment, 1 participant was noncompliant and 1 participant had an adverse event related to chemotherapy. 36 participants completed cycle 1 and cycle 2.||percentage of participants|||Number
686476|NCT01489956|Secondary|Compare the Level of KLH-specific Antibodies in the Serum (Samples From Various Time Points) Between Parts A and B|No data available for analyses.|6 months|Data were not collected and therefore no analyses could be performed.|||||
686477|NCT01489956|Secondary|Other Mechanistic Assessments on Archived Serum Samples Like Anti-KLH Antibodies and Secreted Cytokines (Part B)|No data available for analyses.|6 months|Data were not collected and therefore no analyses could be performed.|||||
686478|NCT01489956|Secondary|Suppression (or Non-activation) of T Cell Stimulation Index Measured by CFSE Staining After KLH Stimulation (Part B)|No data available for analyses.|Day 42|Data were not collected and therefore no analyses could be performed.|||||
686484|NCT01489956|Primary|Participants Demonstrating Tolerance to KLH Using T Cell Stimulation Index (SI) as Measured by 3H-thymidine Incorporation After in Vitro KLH Stimulation of PBMC (Part B)|T cell stimulation index (SI) as measured by 3H-thymidine incorporation after in vitro keyhole limpet hemocyanin (KLH) stimulation of peripheral blood mononuclear cells (PBMC). An SI <3 on Day 32 indicated tolerance to KLH. The SI is the ratio of 3H-thymidine incorporation by T cells in the presence of KLH stimulation to 3H-thymidine incorporation by T cells in the absence of stimulation. Higher values correspond with lower tolerance to KLH.|Day 32|Intent-to-treat||participants|||Number
686485|NCT01489956|Primary|Participants With a Positive Immune Response to T Cell Stimulation Index (SI) as Measured by 3H-thymidine Incorporation After in Vitro KLH Stimulation of PBMC (Part A)|T cell stimulation index (SI) as measured by 3H-thymidine incorporation after in vitro keyhole limpet hemocyanin (KLH) stimulation of peripheral blood mononuclear cells (PBMC). An SI ≥3 on day 16 will indicate the presence of immune response. The SI is the ratio of 3H-thymidine incorporation by T cells in the presence of KLH stimulation to 3H-thymidine incorporation by T cells in the absence of stimulation. Higher values correspond with lower tolerance to KLH.|Day 16|Intent-to-treat||participants|||Number
686486|NCT01489891|Secondary|Likert Four Elements Scale to Evaluate the Satisfaction of Anaesthetist|Define as easiness to reach and maintain the level of sedation and patient comfort during endoscopy: very satisfied, satisfied, neutral, unsatisfied.|8 months|||percentage of participants||95% Confidence Interval|Number
686487|NCT01489891|Secondary|Likert Four Elements Scale to Evaluate the Satisfaction of Endoscopist|Define as easiness to reach the expected objectives for endoscopy without patient interference: very satisfied, satisfied, neutral, unsatisfied.|8 months|||percentage of participants||95% Confidence Interval|Number
686488|NCT01489891|Secondary|Percentage of Participants With Adverse Events in Both Groups|Hypoxemia (SatO2<90% or >4% if the baseline was under 93%), bradycardia (<60 bpm or >10% from baseline), hypotension (systolic blood pressure under 90 mmHg and/or diastolic 60 mmHg), anaphylactic reaction, aspiration o methaemoglobinemia.|Participants will be followed for the duration of hospital stay, an expected average of 2 hours postprocedure|||percentage of participants||95% Confidence Interval|Number
686489|NCT01489891|Primary|Rate of Administration of Propofol 1% Required to Obtain Uniform Sedation During Endoscopy|The propofol will be administered by an expert anaesthetist in repeated bolus (10-20 mg each 30-60 seconds) after an initial induction dosage (0.5-0.6 mg/kg ASA (American Society of Anaesthesiologists) I-II or 0.25-0.35 mg/kg ASA III-IV) to obtain an uniform level of sedation (OAAS 3 and bispectral index (BIS) 70-80) and adequate perceived patient tolerance (no gag-reflex, cough, sudden movements).|8 months|||mcg/kg/min||Standard Deviation|Mean
686490|NCT01489826|Secondary|Maximum Concentration (Cmax) of Cremophor Cycle 1 Day 8|Mean Cmax of Cremophor on Cycle 1 Day 8|Cycle1 - Day 8: pre-dose (0h); 1, 2, 3 h post start of infusion; 5, 10, 15, 30 min post-end infusion; 1, 2, 3, 4, 6, 8, 10 and 24 h post-end infusion.|This analysis was performed on all patients who received study drug and for whom PK samples were obtained (the PK analysis population). For the purposes of the PK analysis, the results from the expansion phase arm were combined with the 30 mg/kg arm.||µL/mL||Geometric Coefficient of Variation|Geometric Mean
686491|NCT01489826|Secondary|Maximum Concentration (Cmax) of Cremophor Cycle 1 Day 1|Mean Cmax of Cremophor on Cycle 1 Day 1|Cycle1 - Day 1: pre-dose (0h); 1, 2, 3 h post start of infusion; 5, 10, 15, 30 min post-end infusion; 1, 2, 3, 4, 6, 8, 10 and 24 h post-end infusion.|This analysis was performed on all patients who received study drug and for whom PK samples were obtained (the PK analysis population). For the purposes of the PK analysis, the results from the expansion phase arm were combined with the 30 mg/kg arm.||µL/mL||Geometric Coefficient of Variation|Geometric Mean
686492|NCT01489826|Secondary|Maximum Concentration (Cmax) of Dexanabinol Cycle 1 Day 8|Mean Cmax of Dexanabinol on Cycle 1 Day 8|Cycle1 - Day 8: pre-dose (0h); 1, 2, 3 h post start of infusion; 5, 10, 15, 30 min post-end infusion; 1, 2, 3, 4, 6, 8, 10 and 24 h post-end infusion.|Concentrations of dexanabinol were not reported for some patients on Days 1 or 8 (including all patients in the 6 mg/kg arm) because the bioanalytical assay, in these instances, was not appropriately validated on the day of the assay. For the purposes of the PK analysis, the results from the expansion phase arm were combined with the 30 mg/kg arm.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
686493|NCT01489826|Secondary|Area Under Curve (AUC) of Cremophor on Cycle 1 Day 8|Geometric mean AUC of Cremophor (0-27hour) on Cycle 1 Day 8.|Cycle 1- Day 8: pre-dose (0h); 1, 2, 3 h post start of infusion; 5, 10, 15, 30 min post-end infusion; 1, 2, 3, 4, 6, 8, 10 and 24 h post-end infusion.|This analysis was performed on all patients who received study drug and for whom PK samples were obtained (the PK analysis population). For the purposes of the PK analysis, the results from the expansion phase arm were combined with the 30 mg/kg arm.||µL.h/mL||Geometric Coefficient of Variation|Geometric Mean
686494|NCT01489826|Secondary|Area Under Curve (AUC) of Cremophor on Cycle 1 Day 1|Geometric mean AUC of Cremophor (0-27hour) on Cycle 1 Day 1.|Cycle 1- Day 1: pre-dose (0h); 1, 2, 3 h post start of infusion; 5, 10, 15, 30 min post-end infusion; 1, 2, 3, 4, 6, 8, 10 and 24 h post-end infusion.|This analysis was performed on all patients who received study drug and for whom PK samples were obtained (the PK analysis population). For the purposes of the PK analysis, the results from the expansion phase arm were combined with the 30 mg/kg arm.||µL.h/mL||Geometric Coefficient of Variation|Geometric Mean
686495|NCT01489826|Secondary|Area Under Curve (AUC) of Dexanabinol on Cycle 1 Day 8|Geometric mean AUC of Dexanabinol (0-infinity) on Cycle 1 Day 8.|Cycle 1- Day 8: pre-dose (0h); 1, 2, 3 h post start of infusion; 5, 10, 15, 30 min post-end infusion; 1, 2, 3, 4, 6, 8, 10 and 24 h post-end infusion.|Concentrations of dexanabinol were not reported for some patients on Days 1 or 8 (including all patients in the 6 mg/kg arm) because the bioanalytical assay, in these instances, was not appropriately validated on the day of the assay. For the purposes of the PK analysis, the results from the expansion phase arm were combined with the 30 mg/kg arm.||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
686496|NCT01489826|Secondary|Progression Free Survival|Tumour response evaluation using RECIST 1.1. (Assessment by CT scan or MRI).|At Screening and after every 2 cycles of treatment (+/-1 week)|Patients included in this analysis were from the 'Efficacy population', defined as those with a baseline and at least one post-baseline assessment of efficacy.||Days||Inter-Quartile Range|Median
686497|NCT01489826|Secondary|Number of Adverse Events (AEs)|AEs will be graded according to the NCI CTCAE v4.03 for cancer clinical trials|30 +/-3 days from the end of the last infusion|The numbers represent the total number of AEs per group. Refer to AE tables for specific information.||Events|||Number
686498|NCT01489826|Secondary|Maximum Concentration (Cmax) of Dexanabinol Cycle 1 Day 1|Mean Cmax of Dexanabinol on Cycle 1 Day 1|Cycle1 - Day 1: pre-dose (0h); 1, 2, 3 h post start of infusion; 5, 10, 15, 30 min post-end infusion; 1, 2, 3, 4, 6, 8, 10 and 24 h post-end infusion.|Concentrations of dexanabinol were not reported for some patients on Days 1 or 8 (including all patients in the 6 mg/kg arm) because the bioanalytical assay, in these instances, was not appropriately validated on the day of the assay. For the purposes of the PK analysis, the results from the expansion phase arm were combined with the 30 mg/kg arm.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
686499|NCT01489826|Secondary|Area Under Curve (AUC) of Dexanabinol on Cycle 1 Day 1|Geometric mean AUC of Dexanabinol (0-infinity) on Cycle 1 Day 1.|Cycle 1- Day 1: pre-dose (0h); 1, 2, 3 h post start of infusion; 5, 10, 15, 30 min post-end infusion; 1, 2, 3, 4, 6, 8, 10 and 24 h post-end infusion.|Concentrations of dexanabinol were not reported for some patients on Days 1 or 8 (including all patients in the 6 mg/kg arm) because the bioanalytical assay, in these instances, was not appropriately validated on the day of the assay. For the purposes of the PK analysis, the results from the expansion phase arm were combined with the 30 mg/kg arm.||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
686500|NCT01489826|Primary|Number of Patients Experiencing Dose Limiting Toxicity (DLT)|"Patients will be sequentially assigned to increasing doses of Dexanabinol, to establish the maximum tolerated dose (MTD) (highest dose it is safe to give patients) or alternatively the maximum administered dose (MAD).
3 patients will be enrolled to a cohort to assess each dose level. Dose escalation to a cohort of 3 new patients will occur when all patients in the previous cohort have completed the first cycle i.e. the first 3 doses followed by observation through to Day 22, and no DLT has occurred. Upon occurrence of the first DLT within a cohort, an additional 3 patients were to be added to that cohort. For a six patient cohort, all 6 patients were to have completed their first dexanabinol treatment cycle with no more than 1 DLT before dose escalation to the next cohort. If 2 or more DLTs occur in a cohort, the next lower dose level will be declared the MTD.
DLTs will be graded for severity based on the National Cancer Institute (NCI) Common Terminology Criteria version 4.03."|Each patient will be followed for 22 days|Patients will be sequentially assigned to increasing doses of Dexanabinol, to establish the MTD (highest dose it is safe to give patients) or alternatively the Maximum Administered Dose(MAD). DLT evaluation in 3 to 6 patients at end of 1 treatment cycle||Number of patients with DLT|||Number
686501|NCT01489670|Primary|Intraocular Pressure (IOP) at Week 12|IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eye at the Final Visit at approximately Week 12. The lower the IOP values the greater the improvement.|Week 12|All participants with complete data available for IOP.||mm Hg||Full Range|Median
686502|NCT01489670|Secondary|Number of Patients Continuing Treatment After 12 Weeks|The number of patients continuing treatment after 12 weeks was determined by the physician answering yes to the question: Is the patient continuing on Lumigan® 0.01% treatment?|Week 12|All participants with data available for this outcome measure.||Participants|||Number
686503|NCT01489670|Secondary|Physician Reported Reasons for Early Discontinuation of Treatment|The number of patients who discontinued from treatment by category is reported. More than one reason may apply to each patient.|12 Weeks|All participants who discontinued treatment early.||Participants|||Number
686504|NCT01489670|Secondary|Physician Evaluation of Tolerability of Treatment|The physician evaluated the patient's tolerability of treatment using a 4-point scale (very good, good, moderate, and poor). The percentage of participants assessed in each category is reported.|Week 12|All participants with data available for this outcome measure.||Participants|||Number
686505|NCT01489670|Secondary|Patient Evaluation of Tolerability of Treatment Using a 4-Point Scale|Patients evaluated their tolerability of treatment using a 4-point scale (very good, good, moderate, and poor). The number of participants in each category is reported.|Week 12|All participants with data available for this outcome measure.||Participants|||Number
686506|NCT01489670|Secondary|Physician Evaluation of Efficacy Using a 5-Point Scale|The physician evaluated efficacy using a 5-point scale (IOP lower than the target, Target IOP reached, IOP decreased but target not reached, IOP increased or No change). The number of participants in each category is reported.|Week 12|All participants with data available for this outcome measure.||Participants|Participants||Number
686507|NCT01489670|Primary|Intraocular Pressure (IOP) at Baseline|IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eye at Baseline.|Baseline|All participants with complete data available for IOP.||mm Hg||Full Range|Median
686508|NCT01489527|Secondary|Percentage of Participants Who Seroconverted to HPV Types 31, 33, 45, or 58|The percent of women that seroconverted among those receiving qHPV vaccine compared to placebo vaccine recipients for HPV types 31, 33, 45, and 58, HPV types not directly targeted by the qHPV vaccine.|18 Months|All treated participants||percentage of participants|||Number
686509|NCT01489527|Secondary|Percentage of Participants Seroconverted to HPV Types 6, 11, 16, or 18|Percentage of participants who seroconverted to HPV types 6, 11, 16, or 18, following receipt of 3 doses of qHPV vaccine.|18 Months|Participants who were randomized to Gardasil and received all 3 doses of Gardasil||percentage of participants|||Number
686510|NCT01489527|Secondary|Percentage of Participants Who Were Seropositive by HPV Type|Percentage of participants who were seropositive to HPV at enrollment, by specific HPV type.|At Enrollment - 5 Month Enrollment Period|All treated participants||percentage of participants|||Number
686511|NCT01489527|Secondary|Study Compliance Rate|Percentage of participants to complete the 3-dose vaccination series and all 4 study visits.|18 Months|All treated participants||percentage of participants|||Number
686512|NCT01489527|Primary|Human Papillomavirus (HPV) Rate|HPV type distribution and prevalence of each HPV type at enrollment.|At Enrollment - 5 Month Enrollment Period|All treated participants||participants|||Number
686513|NCT01489358|Secondary|Chikungunya Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT)|Neutralisation IC50 titre (strain OPY1)|24 weeks after the first vaccination|All subjects who received at least one vaccination||titre||95% Confidence Interval|Geometric Mean
686514|NCT01489358|Secondary|Chikungunya Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT)|Neutralisation IC50 titre (strain OPY1)|Pre-vaccination (Week 0)|All subjects who received at least one vaccination||titre||95% Confidence Interval|Geometric Mean
686515|NCT01489358|Secondary|Chikungunya Antigen-specific ELISA Geometric Mean Titer (GMT)|ELISA titer (strain 37997) For ELISA, week 0 values were used to background correct titres for subsequent weeks.|24 weeks after the first vaccination|All subjects who received at least one vaccination||titre||95% Confidence Interval|Geometric Mean
686516|NCT01489358|Primary|Number of Subjects Reporting 1 or More Unsolicited Adverse Event|"Unsolicited adverse events were recorded from enrollment through 28 days after the second vaccination; and from the third vaccination through 28 days after this vaccination.
Between and after the indicated time periods, through the last expected study visit (i.e., 24 weeks after the third vaccination), only SAEs and new chronic medical conditions were recorded. The number of unsolicited events reported for Group 3 here is lower than the total number of adverse events in the Adverse Event Module, which reports both solicited and unsolicited adverse events."|28 days after each vaccination|All subjects who received at least one vaccination||participants|||Number
686517|NCT01489358|Primary|Number of Subjects Reporting Serious Adverse Events|Serious adverse events were collected at each study visit from the time of first vaccination through the final study visit at 44 weeks after the first vaccination.|44 weeks after first vaccination|All subjects who received at least one vaccination||participants|||Number
686518|NCT01489358|Primary|Number of Subjects With an Any Abnormal Laboratory Result|Blood samples were collected for chemistry, CBC with differential, at baseline and weeks 2, 4, 6, 8, 20, 22, 24 and 44|44 weeks after first vaccination|All subjects who received at least one vaccination||participants|||Number
686519|NCT01489358|Primary|Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Vaccination|Subjects record the occurrence of solicited symptoms on a Memory Aid for 7 days after any vaccination and review the Memory Aid with clinic staff at follow a up visit. Subjects are counted once for each symptom if they indicated experiencing the symptom at any severity during the reporting period. The number reported for all systemic symptoms is the number reporting one or more systemic symptom at any severity.|7 days after any vaccination|All subjects who received at least one vaccination||participants|||Number
686520|NCT01489358|Primary|Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Third Vaccination|Subjects record the occurrence of solicited symptoms on a Memory Aid for 7 days after third vaccination and review the Memory Aid with clinic staff at follow a up visit. Subjects are counted once for each symptom if they indicated experiencing the symptom at any severity during the reporting period. The number reported for all systemic symptoms is the number reporting one or more systemic symptom at any severity.|7 days after the third vaccination|Number of subjects who received the third vaccination||participants|||Number
686521|NCT01489358|Primary|Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Second Vaccination|Subjects record the occurrence of solicited symptoms on a Memory Aid for 7 days after second vaccination and review the Memory Aid with clinic staff at follow a up visit. Subjects are counted once for each symptom if they indicated experiencing the symptom at any severity during the reporting period. The number reported for all systemic symptoms is the number reporting one or more systemic symptom at any severity.|7 days after the second vaccination|All subjects who received the second vaccination||participants|||Number
686522|NCT01489358|Primary|Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of First Vaccination|Subjects record the occurrence of solicited symptoms on a Memory Aid for 7 days after first vaccination and review the Memory Aid with clinic staff at follow a up visit. Subjects are counted once for each symptom if they indicated experiencing the symptom at any severity during the reporting period. The number reported for all systemic symptoms is the number reporting one or more systemic symptom at any severity.|7 days after the first vaccination|All subjects who received the first vaccination||participants|||Number
686523|NCT01489358|Primary|Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Vaccination|Subjects record the occurrence of solicited symptoms on a Memory Aid for 7 days after any vaccination and review the Memory Aid with clinic staff at follow a up visit. Subjects are counted once for each symptom if they indicated experiencing the symptom at any severity during the reporting period. The number reported for all local symptoms is the number reporting one or more local symptom at any severity.|7 days after any vaccination|Number of subjects who received at least one vaccination||participants|||Number
686524|NCT01489358|Primary|Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Third Vaccination|Subjects record the occurrence of solicited symptoms on a Memory Aid for 7 days after third vaccination and review the Memory Aid with clinic staff at follow a up visit. Subjects are counted once for each symptom if they indicated experiencing the symptom at any severity during the reporting period. The number reported for all local symptoms is the number reporting one or more local symptom at any severity.|7 days after the third vaccination|Number of subjects who received the third vaccination||participants|||Number
686525|NCT01489358|Primary|Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Second Vaccination|Subjects record the occurrence of solicited symptoms on a Memory Aid for 7 days after second vaccination and review the Memory Aid with clinic staff at follow a up visit. Subjects are counted once for each symptom if they indicated experiencing the symptom at any severity during the reporting period. The number reported for all local symptoms is the number reporting one or more local symptom at any severity.|7 days after the second vaccination|All subjects who received the second vaccination||participants|||Number
686526|NCT01489358|Primary|Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of First Vaccination|Subjects record the occurrence of solicited symptoms on a Memory Aid for 7 days after first vaccination and review the Memory Aid with clinic staff at follow a up visit. Subjects are counted once for each symptom if they indicated experiencing the symptom at any severity during the reporting period. The number reported for all local symptoms is the number reporting one or more local symptom at any severity.|7 days after the first vaccination|All subjects who received the first vaccination||participants|||Number
686527|NCT01489254|Primary|The Number of T1-Gadolinium Enhancing Lesions During Months 7-9|The primary endpoint was the total number of gadolinium enhancing lesions (i.e., the cumulative number of new and persisting gadolinium enhancing lesions) during months 7 through 9.|9 months|Full Analyis Set (FAS): all randomized subjects who received at least 1 dose of trial medication||Number of lesions||95% Confidence Interval|Mean
686528|NCT01489189|Secondary|Number of Eyes With Greater Than or Equal to 10 Letter Vision Loss||2-year|Participants that completed the 2-year visit.||eyes|Eyes||Number
686529|NCT01489189|Secondary|Number of Eyes Without Active or Regressed Neovascularization on Fundus Photography at 2-years||2-years|Eyes with baseline diabetic retinopathy level 61B or worse (active neovascularization). Last-observation-carried-forward was used for 23 eyes in the anti-VEGF+Deferred PRP group and 25 eyes in the Prompt PRP group missing photographs at 2 years if 1-year fundus photographs were available.||eyes|Eyes||Number
686534|NCT01489189|Secondary|Humphrey Visual Field Test Cumulative Score Change From Baseline|Visual fields, collected using the Humphrey Visual Field analyzer, measured the total point score (sum of retinal sensitivities of all points) tested on 30-2 and 60-4 patterns, which included the mid-peripheral and peripheral visual fields. A lower score indicates greater visual field loss.The cumulative score is the sum of all visual field sensitivity values for each of the four individual quadrants of the visual field (the quadrants are divided by the horizontal and vertical lines). The range can be from 0 to about 600 for the 30-2 test [for each quadrant], and from 0 to about 400 or 450 for the peripheral test.|2-years|Humphrey visual fields were obtained at a subset of sites. Fields with excessive false positive response, excessive false negative response, or excessive fixation loss were excluded from analysis. Twenty-two eyes in the anti-VEGF+deferred PRP group and 25 eyes in the prompt PRP group were excluded.||decibels|Eyes|Inter-Quartile Range|Median
686535|NCT01489189|Secondary|Number of Eyes With Greater Than or Equal to 10 Letter Vision Gain||2-years|Eyes with a baseline letter score of 78 or less (approximate Snellen equivalent 20/32 or worse) from participants that completed the 2-year visit.||eyes|Eyes||Number
686536|NCT01489189|Secondary|Mean Visual Acuity|Visual acuity is measured as a continuous integer letter score from 0 to 100, with higher numbers indicating better visual acuity. A letter score of 85 is approximately 20/20 and a letter score of 70 is approximately 20/40, the legal unrestricted driving limit in most states. A 5-letter change for an individual is approximately equal to a 1-line change on a vision chart.|2-years|Participants that completed the 2-year visit.||letters|Eyes|Standard Deviation|Mean
686537|NCT01489189|Primary|Mean Change in Visual Acuity From Baseline|Visual acuity is measured as a continuous integer letter score from 0 to 100, with higher numbers indicating better visual acuity. A letter score of 85 is approximately 20/20 and a letter score of 70 is approximately 20/40, the legal unrestricted driving limit in most states. A 5-letter change for an individual is approximately equal to a 1-line change on a vision chart.|2-years|Participants that completed the 2-year visit.||letters|Eyes|95% Confidence Interval|Mean
686568|NCT01488877|Secondary|Change From Baseline in Sitting Pulse Rate at Day 15|Sitting pulse rate was measured in the brachial/radial artery for at least 30 seconds. A total of 3 measurements were performed; average of triplicate pulse rate values collected pre-dose on Day 1 served as baseline.|Day 1 (Baseline), 15|Safety analysis set included all participants who received at least 1 dose of study medication.||beats per minute (bpm)||Standard Deviation|Mean
686569|NCT01488877|Secondary|Change From Baseline in Sitting Systolic and Diastolic Blood Pressure at Day 15|Systolic blood pressure (BP): BP when heart is contracting; maximum arterial pressure during contraction of left ventricle of heart. Diastolic blood pressure: BP when heart is relaxing; minimum arterial pressure during relaxation and dilation of ventricles of heart. A total of 3 measurements were performed; average of triplicate BP values collected pre-dose on Day 1 served as baseline. The same arm and same sized cuff (properly sized and calibrated) was used throughout the study, after participant sat for 5 minutes for the first measurement and 2 minutes for second and third measurements.|Day 1 (Baseline), 15|Safety analysis set included all participants who received at least 1 dose of study medication.||millimeter of mercury (mmHg)||Standard Deviation|Mean
686570|NCT01488877|Secondary|Plasma Pharmacokinetic (PK) Parameters|PK parameters were to be evaluated at Day 1 and Day 14 (steady state). Maximum observed plasma concentration (Cmax), time to reach maximum observed plasma concentration (Tmax), area under the curve from time zero to end of dosing interval (AUCtau) were to be evaluated at both Day 1 and Day 14 (steady state). Minimum observed plasma trough concentration (Cmin), average plasma concentration (Cavg), apparent oral clearance (CL/F), apparent volume of distribution (Vz/F) were to be evaluated only at Day 14 (steady state). Observed accumulation ratio (Rac) was also planned to be analyzed.|0 (pre-dose), 2, 4, 6, 8, 10, 14, 24 hours post-dose on Day 1, 14|Data for all pre-specified PK parameters were not analyzed because a decision was made to prematurely terminate the study.|||||
686571|NCT01488877|Primary|Number of Participants With Confirmed and Severe Hyperkalemia|Hyperkalemia refers to the condition in which the concentration of the electrolyte potassium in the blood is elevated. Confirmed hyperkalemia is defined as serum potassium level greater than (>) upper limit of normal (ULN) of 5.4 mEq/L. Severe hyperkalemia is defined as serum potassium level >= 6.0 mEq/L. Number of participants with at least 1 confirmed or severe hyperkalemia is reported.|Baseline up to Day 15|Safety analysis set included all participants who received at least 1 dose of study medication.||participants|||Number
686572|NCT01488877|Primary|Change From Baseline in Serum Potassium at Day 15|Baseline value calculated as the average of -24 hours (pre-dose) measurement on Day -1 and 0 hours (immediately pre-dose) measurement on Day 1. Day 15 value calculated was average of 0 hours (immediately pre-dose) measurement on Day 14 and measurement obtained prior to discharge on Day 15. Change from baseline values were presented under time point of Day 15.|Baseline, Day 14, 15|Safety analysis set included all participants who received at least 1 dose of study medication.||mEq/L||Full Range|Median
686573|NCT01488877|Primary|Change From Baseline in Serum Potassium at Day 8|Baseline value calculated as the average of -24 hours (pre-dose) measurement on Day -1 and 0 hours (immediately pre-dose) measurement on Day 1. Day 8 value calculated was average of 0 hours (immediately pre-dose) measurements on Day 7 and 8. Change from baseline values were presented under time point of Day 8.|Baseline, Day 7, 8|Safety analysis set included all participants who received at least 1 dose of study medication.||milliequivalent/liter (mEq/L)||Full Range|Median
686574|NCT01488578|Primary|Confirmation of Frequent Treatment Related Adverse Events (TRAEs) at the End of Observation Period.|The Treatment Related Adverse Events (TRAEs) at the end of observation period with an incidence of 1% or higher.|12 week|Safety analysis population included all enrolled subjects who had received at least 1 confirmed, administration of Detrusitol.||events|||Number
686575|NCT01488578|Secondary|Risk Factors for the Proportion of Responders of Tolterodine-Previous Treatment|Number of participants with response to tolterodine to determine whether with or without previous treatment is significant risk factor.|12 week|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
686576|NCT01488578|Secondary|Risk Factors for the Proportion of Responders of Tolterodine-Number of Urinary Incontinence Episodes Per Day|Number of participants with responders of tolterodine to determine the Number of urinary incontinence episodes per day is significant risk factor.|12 week|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
686577|NCT01488578|Secondary|Risk Factors for the Proportion of Responders of Tolterodine-Number of Urinations Per Day (During Sleep)|Number of participants with responders of tolterodine to determine the Number of urinations per day (during sleep) is significant risk factor.|12 week|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
686578|NCT01488578|Secondary|Risk Factors for the Proportion of Responders of Tolterodine-Urinary Urgency|Number of participants with responders of tolterodine to determine whether with or without Urinary urgency is significant risk factor.|12 week|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
686579|NCT01488578|Secondary|Risk Factors for the Proportion of Responders of Tolterodine-Severity of Overactive Bladder|Number of participants with responders of tolterodine to determine whether mild, moderate or severe is significant risk factor.|12 week|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
686580|NCT01488578|Secondary|Number of Unlisted Treatment Related Adverse Events (TRAEs)Reported in at Least 5 Participants|All observed or volunteered adverse events and the investigator’s opinion of the causal relationship to the study treatment were reported. Definition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert.|12 week|Safety analysis population included all enrolled subjects who had received at least 1 confirmed, administration of Detrusitol.||events|||Number
686581|NCT01488578|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Tolterodine - Comorbidity of Prostatic Hypertrophy|Number of participants with Treatment Related Adverse Events (TRAEs) of tolterodine to determine whether with or without comorbidity of benign prostatic hypertrophy (BPH) is significant risk factor.|12 week|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of this drug was confirmed.||participants|||Number
686582|NCT01488578|Secondary|Risk Factors for the Proportion of Responders of Tolterodine-Age|Number of participants with responders of tolterodine to determine whether <65 years or >=65 years is significant risk factor.|12 week|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
686583|NCT01488578|Secondary|Risk Factors for the Proportion of Responders of Tolterodine-Complications|Number of participants with responders of tolterodine to determine whether with or without complications is significant risk factor.|12 week|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
686584|NCT01488578|Secondary|Risk Factors for the Proportion of Responders of Tolterodine-Gender|Number of participants with responders of tolterodine to determine whether male or female is significant risk factor.|12 week|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
686585|NCT01488578|Secondary|Risk Factors for the Proportion of Responders of Tolterodine-Non-drug Therapies|Number of participants with responders of tolterodine to determine whether with or without Non-drug therapies is significant risk factor.|12 week|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
686586|NCT01488578|Primary|Number of Participants With an Investigator’s Assessment of Clinical Outcome at End of the Study.|Clinical overall effectiveness was evaluated by investigators based on clinical symptoms, etc, at the end of observation period.|12 week|"The efficacy analysis population included all subjects from the safety analysis population in whom the efficacy of this drug could be evaluated.
Number of participants evaluable for which was evaluated effect."||participants|||Number
686587|NCT01488578|Primary|"Number of Participants Which Was Evaluated as Degree of Satisfaction."|Participant satisfaction was evaluated by investigators based on questioning the participants at the end of observation period using choices: Satisfied, Dissatisfied, Neither of the above.|12 week|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
686588|NCT01488578|Secondary|Risk Factors for the Proportion of Responders of Tolterodine-Concomitant Drugs|Number of participants with responders of tolterodine to determine whether with or without concomitant drugs is significant risk factor.|12 week|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
686589|NCT01488578|Primary|Confirmation of the Incidence of All Treatment Related Adverse Events (TRAEs).|All observed or volunteered adverse events and the investigator’s opinion of the causal relationship to the study treatment were reported. Definition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product.|12 weeks|Safety analysis population included all enrolled subjects who had received at least 1 confirmed, administration of Detrusitol.||participants|||Number
686590|NCT01488487|Secondary|Objective Response Rate (ORR)|"ORR is the rate of complete responses (CRs) + partial responses (PRs) as determined by RECIST (v1.1) and modified HCC RECIST criteria. Responses defined as follows:
CR: disappearance of all clinical/radiological evidence of tumor including any intratumoral arterial enhancement in all target lesions.
Partial Response (PR): at least a 30% decrease in the sum of diameters of viable (contrast enhancement in the arterial phase) target lesions, referencing the baseline sum.
Stable Disease (SD): any cases that do not qualify for either partial response or progressive disease.
Progressive Disease (PD): an increase of at least 20% in the sum of the diameters of viable target lesions, referencing the nadir sum, and/or the appearance of one or more new lesions. A new hepatic nodule signals PD when the longest diameter is at least 10 mm and the nodule shows the typical vascular pattern of HCC on dynamic imaging or if at least 1-cm interval growth is seen in subsequent scans."|3.5 years|Two patients were not evaluable; one due to death prior to radiographic evaluation (death clinically attributed to progressive disease) and the other due to early termination of treatment due to intolerance.||percentage of participants|||Number
686591|NCT01488487|Secondary|Overall Survival (OS)|Overall survival is defined as the time from study enrollment until death.|3.5 years|||months||95% Confidence Interval|Median
686592|NCT01488487|Secondary|Number of Individuals Experiencing Toxicity|Safety determinations are based on the rate of drug-related adverse events (AEs) reported based upon the toxicity as measured by the NCI Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0).|3.5 years|||participants|||Number
686692|NCT01486927|Secondary|Incremental Recovery (Part 1)|Incremental recovery of a single infusion of octocog alfa and rVIII-SingleChain with correction for subject's predose plasma FVIII activity. FVIII activity values for octocog alfa are dose-adjusted for chromogenic potency.|At 30 minutes after infusion|||[IU/dL]/[IU/kg]||Standard Deviation|Mean
686593|NCT01488487|Primary|Time to Progression (TTP)|Time to progression is defined as the time from study enrollment until radiological progression in a previously embolized lobe, development of new lesions in an untreated lobe, or evidence of extrahepatic progression (based on modified Hepatocellular Carcinoma (HCC) Response Evaluation Criteria In Solid Tumors (RECIST) criteria). Patients will be followed until death. Patients that die of causes unrelated to the study drug without evidence of progression will be censored.|3.5 years|||months||95% Confidence Interval|Median
686594|NCT01488448|Primary|Length of Stay in the Study-LOS by Per Protocol Analysis|Length of stay will be defined by the duration between the time of first study treatment to the time a discharge order is placed. Alternatively, if a patient remains inpatient for other, non-bronchiolitis related reasons (i.e. social reasons, etc.) the time a patient could be discharged from the standpoint of bronchiolitis as documented by the attending, will be used.|Time of first study treatment until time of discharge|Per protocol analysis (only includes participants who completed the study)||Days||Inter-Quartile Range|Median
686595|NCT01488448|Post-Hoc|LOS Analysis for Patients Whose Study Entry Respiratory Distress Assessment Instrument (RDAI) Was Greater Than or Equal to 4 or Who Had Hypoxia <92%||through hospitalization/while receiving study medication, average 2-3 days|Subgroup of patients who had a study entry Respiratory Distress Assessment Instrument (RDAI) of greater than or equal to 4 points OR hypoxia <92% on admission||days||Inter-Quartile Range|Median
686596|NCT01488448|Post-Hoc|LOS Subgroup Analysis of Patients With a History of Prematurity||through hospitalization/while receiving study medication, average 2-3 days|Patients who reported a history of prematurity/whose Gestational age was <37 weeks||days||Inter-Quartile Range|Median
686597|NCT01488448|Post-Hoc|LOS in Patients With a History of Previous Wheeze||through hospitalization/while receiving study medication, average 2-3 days|Subgroup of the study population who reported a history of wheezing prior to this admission||days||Inter-Quartile Range|Median
686598|NCT01488448|Post-Hoc|LOS in Subgroup of Patients With Testing Positive for Respiratory Syncitial Virus (RSV+)||through hospitalization/while receiving study medication, average 2-3 days|This is the population in the study whose RSV testing was positive.||days||Inter-Quartile Range|Median
686599|NCT01488448|Secondary|Total Adverse Events|Clinical worsening events (defined prior) + 7 day readmissions|Time of enrollment in the study through 1 week after hospital discharge|||adverse events|||Number
686600|NCT01488448|Secondary|Clinical Worsening|transfer to the Pediatric Intensive Care Unit (PICU) (including withdrawn from the study for bronchodilator administration who were then transferred to the PICU), or Respiratory Distress Assessment Instrument (RDAI) increase of 4 or more points within 30 minutes of a study treatment|though hospitalization/time period receiving study treatment, average 2-3 days|all patients enrolled in the study were analyzed for events related to clinical worsening||participants|||Number
686601|NCT01488448|Secondary|Readmission for Bronchiolitis Within 7 Days of Discharge|Phone call at 7 days to assess for readmission to any hospital|within 7 days of hospital discharge|This population is those who completed the study.||participants|||Number
686602|NCT01488448|Primary|Length of Stay in the Study-LOS--Intention to Treat Analysis|Length of stay will be defined by the duration between the time of first study treatment to the time a discharge order is placed. Alternatively, if a patient remains inpatient for other, non-bronchiolitis related reasons (i.e. social reasons, etc.) the time a patient could be discharged from the standpoint of bronchiolitis as documented by the attending, will be used.|Time of first study treatment until time of discharge|Intention to Treat Analysis||Days||Inter-Quartile Range|Median
686603|NCT01488409|Secondary|Change From Baseline in Lipid Profile at 6-months|Change in direct low density lipoprotein (LDL) cholesterol is given|Change from Baseline to 6-months|all available data used||mg/dL||Standard Deviation|Mean
686604|NCT01488409|Secondary|Change From Baseline in Intramyocellular Lipid Content at 6-months|Change in tibialis intramyocellular lipid (IMCL) normalized to creatinine is given.|Change from Baseline to 6-months|all available data used||ratio of IMCL peak to Creatinine peak||Standard Deviation|Mean
686605|NCT01488409|Secondary|Change From Baseline in Mitochondrial Density at 6 Months|Muscle tissue obtained from biopsy will be used to assess mitochondrial number and morphology by microscopes at Baseline and at 6-months. The change in mitochondrial density from 6 months to baseline is given.|Change from Baseline to 6-months|all available data used||percentage of total muscle fiber area||Standard Deviation|Mean
686606|NCT01488409|Secondary|Change From Baseline in Insulin Sensitivity at 6-months|Change in insulin resistance assessed by hyperinsulinemic-euglycemic clamp study at Baseline and at 6-months. Change in insulin-stimulated glucose uptake (M) during 40 mU/m2/min insulin clamp is given.|Change from Baseline to 6-months visit|all available data used||mg/kg/min||Standard Deviation|Mean
686607|NCT01488409|Primary|Change From Baseline in Phosphocreatine Recovery (ViPCr) at 6-months|The rate of recovery of phosphocreatine concentration after depletion by exercise is considered a measurement of mitochondrial function. Change in phosphocreatine recovery from baseline to 6 months will therefore give a measurement of change in mitochondrial function. ViPCR is given -- a higher value indicates better mitochondrial function.|Change from Baseline to 6-months Visit|all available data used||mM/s||Standard Deviation|Mean
686608|NCT01488370|Secondary|Successful Intubation After Four Laryngoscopy Attempts||Through endotracheal intubation during induction of general anesthesia, an average of 10 minutes|||Participants|||Count of Participants
686609|NCT01488370|Secondary|Successful Intubation After Three Laryngoscopy Attempts||Less than one day, representing the day of surgery and period of endotracheal intubation during induction of general anesthesia.|||Participants|||Count of Participants
686610|NCT01488370|Secondary|Successful Intubation After Two Laryngoscopy Attempts||Less than one day, representing the day of surgery and period of endotracheal intubation during induction of general anesthesia.|||Participants|||Count of Participants
686611|NCT01488370|Secondary|Successful Intubation After One Laryngoscopy Attempt|Other secondary outcome measures will be the use of external laryngeal manipulation to improve glottic view, tissue trauma and type,and method of rescue if initial intubation attempt proves unsuccessful.|Less than one day, representing the day of surgery and period of endotracheal intubation during induction of general anesthesia.|||Participants|||Count of Participants
686735|NCT01486043|Secondary|Hemoglobin A1c||At 1 month|||percent of hemoglobin||Full Range|Mean
686736|NCT01486043|Secondary|Serum Fructosamine Level||At 1 month|||uM||Full Range|Mean
686737|NCT01486043|Primary|Length of Insulin Therapy (Days)||During the 30 days of induction chemotherapy (plus or minus 2 weeks)|||days||Full Range|Mean
686612|NCT01488370|Primary|Measurement of Time to Intubation Will Begin at the Time of Mouth Opening and End With the Removal of the Tip of the Laryngoscope Blade From the Patient's Mouth After Successful Endotracheal Intubation.||Less than one day, representing the day of surgery and period of endotracheal intubation during induction of general anesthesia|Time to successful tracheal intubation||Seconds||95% Confidence Interval|Mean
686613|NCT01488188|Secondary|Cell Mediated Immune Responses|Interferon gamma production in peripheral blood monocyte (PBMC) after in vitro re-stimulation with influenza virus antigen at 21 days after vaccination.|21 days after vaccination|||pg/ml||Full Range|Median
686614|NCT01488188|Secondary|Salivary IgA|Salivary Flu-specific IgA titer at Days 21 after vaccination|21 days after vaccination|||Titer||Full Range|Median
686615|NCT01488188|Secondary|Blood Immunoglobulin G (IgG) and Immunoglobulin A (IgA)-Antibody Secreting Cell Number to Flu Virus|Flu virus-specific IgG- and IgA -antibody secreting cells per ml of blood at 7 days after vaccination|7 days after vaccination|||cells/ml||Full Range|Median
686616|NCT01488188|Primary|Passive Haemagglutination Inhibition Titer.|Passive haemagglutination inhibition titer of serum at 21 days after vaccination.|21 days after vaccination|||Titer||Full Range|Median
686617|NCT01488097|Secondary|High Sensitivity C-reactive Protein (Hs-CRP) Change From Baseline||From baseline (study LAL-CL01) to week 12, week 24, week 52, and week 104|Subjects in the FAS for whom hs-CRP data were available at both baseline and the indicated timepoint||change from baseline in mg/dL||Standard Deviation|Mean
686618|NCT01488097|Secondary|Serum Ferritin Change From Baseline||From baseline (study LAL-CL01) to week 12, week 24, week 52, and week 104|Subjects in the FAS for whom serum ferritin data were available at both baseline and the indicated timepoint||change from baseline in µg/L||Standard Deviation|Mean
686619|NCT01488097|Secondary|Lipid Changes From Baseline|Change from baseline in total cholesterol (Total-C), high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), and triglycerides (TG).|From baseline (study LAL-CL01) to week 10 or 12, week 24, week 52, week 104|Subjects in the FAS for whom lipid data were available at both baseline and the indicated timepoint||change from baseline in mg/dL||Standard Deviation|Mean
686620|NCT01488097|Primary|ALT and AST Changes From Baseline|Changes from baseline (study LAL-CL01) to specific post-treatment time points in study LAL-CL04 for alanine aminotransferase (ALT) and aspartate aminotransferase (AST).|From baseline (study LAL-CL01) to week 12, week 24, week 52, and week 104|Subjects in the Full Analysis Set (FAS) for whom ALT and AST data were available at both baseline (study LAL-CL01) and the indicated post-treatment time point in study LAL-CL04. The FAS included all subjects who received at least 1 complete infusion of sebelipase alfa in this study and who had at least 1 post-treatment measurement in this study.||Change from baseline in U/L||Standard Deviation|Mean
686621|NCT01488097|Secondary|GGT and ALP Changes From Baseline|Changes from baseline (study LAL-CL01) to specific post-treatment time points in study LAL-CL04 for gamma glutamyltransferase (GGT) and alkaline phosphatase (ALP).|From baseline (study LAL-CL01) to week 12, week 24, week 52, and week 104|Subjects in the Full Analysis Set (FAS) for whom GGT and ALP data were available at both baseline and the indicated post-treatment time point in study LAL-CL04. The FAS included all subjects who received at least 1 complete infusion of sebelipase alfa in this study and who had at least 1 post-treatment measurement in this study.||Change from baseline in U/L||Standard Deviation|Mean
686622|NCT01488097|Secondary|Change From Baseline in Liver Fat Content|Percentage change in liver fat content from the LAL-CL04 baseline to the indicated post-treatment time point in study LAL-CL04, as assessed by multi-echo gradient-echo MRI|From baseline (study LAL-CL04) to week 10 or 12, week 24, week 52, week 104|Subjects in the full analysis set (FAS) for whom liver content data were available at both baseline (study LAL-CL04) and the indicated post-treatment time point in study LAL-CL04. The FAS included all subjects who received at least 1 complete infusion of sebelipase alfa in this study and who had at least 1 post-treatment measurement in this study.||percentage change from baseline||Standard Deviation|Mean
686623|NCT01488097|Secondary|Change From Baseline in Liver Volume|Change in liver volume (in multiples of normal [MN]) from the LAL-CL04 baseline to the indicated post-treatment time point in study LAL-CL04, as assessed by MRI|From baseline (study LAL-CL04) to week 10 or 12, week 24, week 52, week 104|Subjects in the Full Analysis Set (FAS) for whom liver volume data were available at both baseline (study LAL-CL04) and the indicated post-treatment time point in study LAL-CL04. The FAS included all subjects who received at least 1 complete infusion of sebelipase alfa in this study and who had at least 1 post-treatment measurement in this study.||change from baseline in MN||Standard Deviation|Mean
686624|NCT01488071|Secondary|Change From Baseline in SDS Total Score at Week 12||Baseline and Week 12|FAS||units on a scale||Standard Error|Mean
686625|NCT01488071|Secondary|Change From Baseline in SDS Total Score at Week 8|The Sheehan Disability Scale (SDS) comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). The higher the score, the more severe, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Baseline and Week 8|FAS||units on a scale||Standard Error|Mean
686626|NCT01488071|Secondary|Proportion of Patients Who Are in Remission at Week 12 (Remission is Defined as a MADRS Total Score <=10)||Week 12|FAS, LOCF||percentage of participants|||Number
686627|NCT01488071|Secondary|Proportion of Patients Who Are in Remission at Week 8 (Remission is Defined as a MADRS Total Score <=10)||Week 8|FAS, LOCF||percentage of participants|||Number
686628|NCT01488071|Secondary|Proportion of Patients Who Respond at Week 12 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline)||Baseline and Week 12|FAS, LOCF||percentage of participants|||Number
686629|NCT01488071|Secondary|Proportion of Patients Who Respond at Week 8 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline)||Baseline and Week 8|FAS, last observation carried forward (LOCF)||percentage of participants|||Number
686630|NCT01488071|Secondary|Change in Clinical Status Using CGI-I Score at Week 12||Week 12|FAS||units on a scale||Standard Error|Mean
686631|NCT01488071|Secondary|Change in Clinical Status Using CGI-I Score at Week 8|The Clinical Global Impression - Global Improvement (CGI-I) is a 7-point scale rated from 1 (very much improved) to 7 (very much worse). The investigator rated the patient's overall improvement relative to baseline, whether or not, in the opinion of the investigator, this was entirely due to the drug treatment. Higher score = more affected.|Week 8|FAS||units on a scale||Standard Error|Mean
686632|NCT01488071|Secondary|Change From Baseline in CGI-S Score at Week 12||Baseline and Week 12|FAS||units on a scale||Standard Error|Mean
686633|NCT01488071|Secondary|Change From Baseline in CGI-S Score at Week 8|The Clinical Global Impression - Severity of Illness (CGI-S) is a 7-point scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The investigator should use his/her total clinical experience with this patient population to judge how mentally ill the patient is at the time of rating. Higher score indicates that the subject is more ill, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Baseline and Week 8|FAS||units on a scale||Standard Error|Mean
686634|NCT01488071|Secondary|Change From Baseline in HAM-A Total Score at Week 12||Baseline and Week 12|FAS||units on a scale||Standard Error|Mean
686635|NCT01488071|Secondary|Change From Baseline in HAM-A Total Score at Week 8|The Hamilton Anxiety Rating Scale (HAM-A) consists of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behaviour at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic, and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total score from 0 to 56; higher score indicates greater anxiety, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Baseline and Week 8|FAS||units on a scale||Standard Error|Mean
686636|NCT01488071|Secondary|Change From Baseline in MADRS Total Score at Week 12||Baseline and Week 12|FAS||units on a scale||Standard Error|Mean
686637|NCT01488071|Primary|Change From Baseline in MADRS Total Score at Week 8|The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Baseline and Week 8|full-analysis set (FAS)||units on a scale||Standard Error|Mean
686638|NCT01488019|Secondary|Rescue Medication Usage|Number of puffs of rescue medication (albuterol pMDI) used per day|0 to 52 weeks|Full Analysis Set: all subjects randomized who took at least one dose of study medication. Subjects were analyzed according to their assigned treatment at randomization.||Mean Puffs per Day||Standard Deviation|Mean
686639|NCT01488019|Secondary|Summary of Subjects Requiring Intubation or Non-Invasive Ventilation||0 to 52 weeks|Full Analysis Set: all subjects randomized who took at least one dose of study medication. Subjects were analyzed according to their assigned treatment at randomization.||Participants|||Count of Participants
686640|NCT01488019|Secondary|Health Care Utilization and Economic Impact - Number of Emergency Department Visits||0 to 52 weeks|Full Analysis Set: all subjects randomized who took at least one dose of study medication. Subjects were analyzed according to their assigned treatment at randomization.||Participants|||Count of Participants
686641|NCT01488019|Secondary|Transition Dyspnea Index|The Transition Dyspnea Index (TDI) measures changes in dyspnea severity from the baseline as established by the BDI. It has 3 components: change in functional impairment, change in magnitude of task, and change in magnitude of effort, and each component is rated on a scale ranging from -3 (major deterioration) to +3 (major improvement). The 3 components are summed to provide a total score ranging from -9 to +9. The lower the score, the more deterioration in severity of dyspnea.|On treatment at months 3, 6, 9 and 12|Full Analysis Set: all subjects randomized who took at least one dose of study medication. Subjects were analyzed according to their assigned treatment at randomization.||units on a scale||Standard Error|Least Squares Mean
686642|NCT01488019|Secondary|Saint Georges Respiratory Questionnaire Scores: Changes From Baseline at Months 3, 6, 9, 12|Saint Georges Respiratory Questionnaire comprises 50 items in 3 sections, Symptoms, Activity, Impact, measuring health status in chronic airflow limitation. Symptoms captures level of symptomatology. Activity and Impact responses are either “yes” or “no”. Scoring is from 0 to 100; 0 = no life quality impairment. A summary score for all items is calculated and ranges from 0 to 100, where 0 indicates best possible health status, 100 represents worst possible health status. Scores are calculated using weights attached to each item in the questionnaire - 4 unit changes are clinically meaningful.|On treatment at months 3, 6, 9 and 12|Full Analysis Set: all subjects randomized who took at least one dose of study medication. Subjects were analyzed according to their assigned treatment at randomization. Only subjects with data collected were included||units on a scale||Standard Error|Least Squares Mean
686643|NCT01488019|Secondary|IC Changes From Baseline at Months 3, 6, 9 and 12||On treatment at months 3, 6, 9 and 12|Full Analysis Set: all subjects randomized who took at least one dose of study medication. Subjects were analyzed according to their assigned treatment at randomization. Only subjects with data collected and valid measurements included||Litres||Standard Deviation|Mean
686644|NCT01488019|Secondary|FVC Changes From Baseline at Months 3, 6, 9 and 12||On treatment at months 3, 6, 9 and 12|Full Analysis Set: all subjects randomized who took at least one dose of study medication. Subjects were analyzed according to their assigned treatment at randomization. Only subjects with data collected and valid measurements included||Litres||Standard Deviation|Mean
686645|NCT01488019|Secondary|FEV1 Changes From Baseline at Months 3, 6, 9 and 12||On treatment at months 3, 6, 9 and 12|Full Analysis Set: all subjects randomized who took at least one dose of study medication. Subjects were analyzed according to their assigned treatment at randomization. Only subjects with data collected and valid measurements included||Litres||Standard Error|Least Squares Mean
686656|NCT01487668|Primary|Physical Health-related Quality of Life|The outcome is measures by changes in the Veterans short form 12-item (VR-12) survey, which includes a physical and mental health component score (PCS and MCS, respectively). Each component score (PCS and MCS) has a range of 0-100, with a higher score on the PCS and MCS indicating better outcome, or better physical or mental health-related quality of life, respectively.|12 months|||units on a scale||Standard Deviation|Mean
686646|NCT01488019|Secondary|Kaplan-Meier Probability of Protocol Defined COPD Exacerbation at 52 Weeks|COPD exacerbations were defined as events in the natural course of disease characterized by an increase from baseline in two of the following symptoms: dyspnea, cough, and sputum production that was beyond normal day-to-day variations, was acute in onset, that persisted for at least two consecutive days, and that warranted a change in their regular medication.The change could be either the initiation of additional treatment(s) or the intensification of a treatment the subject was already receiving, and the change must have been specifically to address the exacerbation event. COPD exacerbations occurring after the time of withdrawal or completion of the study were not included.|0 to 52 weeks|Safety Set - All subjects who were randomized to treatment and took at least one dose of study medication. Subjects were analyzed according to the actual treatment they received for the majority of the study.||percent|||Number
686647|NCT01488019|Secondary|Number of Subjects With Protocol-Defined COPD Exacerbation|COPD exacerbations were defined as events in the natural course of disease characterized by an increase from baseline in two of the following symptoms: dyspnea, cough, and sputum production that was beyond normal day-to-day variations, was acute in onset, that persisted for at least two consecutive days, and that warranted a change in their regular medication. The change could be either the initiation of additional treatment(s) or the intensification of a treatment the subject was already receiving, and the change must have been specifically to address the exacerbation event. COPD exacerbations occurring after the time of withdrawal or completion of the study were not included.|0 to 52 weeks|Safety Set - All subjects who were randomized to treatment and took at least one dose of study medication. Subjects were analyzed according to the actual treatment they received for the majority of the study.||Participants|||Count of Participants
686648|NCT01488019|Secondary|Individual Components of the Primary Composite Endpoint - First COPD-related ER Visit and First COPD Exacerbation-Related Hospitalization||0 to 52 weeks|Safety Set - All subjects who were randomized to treatment and took at least one dose of study medication. Subjects were analyzed according to the actual treatment they received for the majority of the study.||Participants|||Count of Participants
686649|NCT01488019|Secondary|Summary of All Cause Mortality, COPD Related Mortality and Respiratory Related Mortality|An independent Mortality Adjudication Board was used to evaluate all deaths that occurred in the study and for assigning cause of death and COPD-relatedness.|0 to 52 weeks|Safety Set - All subjects who were randomized to treatment and took at least one dose of study medication. Subjects were analyzed according to the actual treatment they received for the majority of the study.||Participants|||Number
686650|NCT01488019|Primary|Kaplan-Meier Probability of Respiratory Death, First COPD-Related Emergency Room Visit, or First COPD Exacerbation-Related Hospitalisation at 52 Weeks|The primary endpoint was the combined incidence of respiratory death, first COPD-related ER visit or first COPD exacerbation-related hospitalization (whichever occurred first from the time of randomization to the end of the study). The time-to-first event was measured and analyzed in units of weeks and was summarized by treatment for subjects in the Safety Set. An independent Mortality Adjudication Board was used to evaluate all deaths that occurred in the study and for assigning cause of death and COPD-relatedness.|0 to 52 weeks|Safety Set - All subjects who were randomized to treatment and took at least one dose of study medication. Subjects were analyzed according to the actual treatment they received for the majority of the study.||percent|||Number
686651|NCT01488019|Primary|Number of Subjects With a Primary Event of Respiratory Death, First COPD-Related Emergency Room Visit, or First COPD Exacerbation-Related Hospitalisation|The primary endpoint was the combined incidence of respiratory death, first COPD-related ER visit or first COPD exacerbation-related hospitalization (whichever occurred first from the time of randomization to the end of the study). The time-to-first event was measured and analyzed in units of weeks and was summarized by treatment for subjects in the Safety Set. An independent Mortality Adjudication Board was used to evaluate all deaths that occurred in the study and for assigning cause of death and COPD-relatedness.|0 to 52 weeks|Safety Set - All subjects who were randomized to treatment and took at least one dose of study medication. Subjects were analyzed according to the actual treatment they received for the majority of the study.||Participants|||Count of Participants
686652|NCT01487954|Secondary|Change in Urine pH|A paired sample t-test (a=0.05) assessing change in urine pH between before treatment day 0 and after radiation and alkaline water treatment day 33.|at baseline and at week 5 (day 33)|Only the first ten patients in the alkaline water group, who took part in the safety lead-in portion of the study were analyzed for urine pH||units on pH scale||Standard Deviation|Mean
686653|NCT01487954|Primary|Acute and Grade 2 or Higher Radiation-related Skin Toxicity as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0|Information will include the type, severity, time of onset and resolution of its onset, and its probable association with the study regimen. Frequency tables will be constructed to summarize observed incidents by severity and type of toxicity during weekly radiation treatment and 1 month after radiation treatment. Observed toxicity differences among the treatment arms may be reported in frequency tables.|at 1 month after treatment|||percentage of participants|||Number
686654|NCT01487863|Primary|Cumulative CD54 Upregulation Ratio Between the Cohorts.|An analysis of variance model for the log transformed cumulative CD54 upregulation ratio (CD54 upregulation is the fold increase in the final product (FP) from buoyant density separations (BDS) step 65. BDS65 step refers to sample taken after both BDS77 and BDS65 but before ex vivo culture in the presence of antigen PA2024. FP refers to sample taken after ex vivo culture) that includes the antigen concentration cohort as the independent variable was performed. Subjects who received all 3 infusions were included.|Over the course of sipuleucel-T therapy (approximately 1 month)|The efficacy population is defined as all randomized subjects. All the subjects in the efficacy population were analyzed according to the treatment that they were randomized to receive.||Ratio ofCD54 molecules on BDS65:FP cells||Standard Error|Mean
686655|NCT01487668|Secondary|Improved Mental Health-related Quality of Life|Change in SF-12 mental health scores from baseline to 12 months. The outcome is measures by changes in the Veterans short form 12-item (VR-12) survey, which includes a physical and mental health component score (PCS and MCS, respectively). Each component score (PCS and MCS) has a range of 0-100, with a higher score on the PCS and MCS indicating better outcome, or better physical or mental health-related quality of life, respectively.|12 months|||units on a scale||Standard Deviation|Mean
686657|NCT01487577|Secondary|Pharmacokinetic Analysis of MMF Steady State Concentration to Evaluate MMF Dose Relationships to Drug Exposure.|Pharmacokinetic analysis includes, but is not limited to, steady-state concentrations.|100 days|||mcg/mL||Full Range|Median
686672|NCT01486966|Secondary|Incidence of Hypoglycaemic Episodes|"All events summarized were treatment emergent hypoglycaemic events. Hypoglycaemic episodes were summarized based on the ADA classification and also according to an additional definition.
Severe hypoglycemia: ADA definition. Minor hypoglycaemic episode: an episode with symptoms with confirmation by plasma glucose (PG) < 3.1 mmol/l (56 mg/dl) and was handled by the subject himself/herself, or any asymptomatic PG value < 3.1 mmol/l (56 mg/dl).
A hypoglycaemia episode was defined as nocturnal if the time of onset was between 00:01 and 05:59 a.m. (both included), otherwise it was diurnal."|Weeks 0-2|Safety analysis set included all subjects receiving at least one dose of the trial products.||events|||Number
686673|NCT01486966|Secondary|Change From Baseline in Fructosamine After Two Weeks of Treatment||Week 0, week 2|Full analysis set using LOCF (Last Observation Carried Forward) included all randomised subject. The 2 subjects who withdrew after randomisation were excluded from the efficacy analyses.||Umol/L||Standard Error|Least Squares Mean
686674|NCT01486966|Secondary|Percentage of Subjects Achieving FPG Target Without Nocturnal Hypoglycaemia After Two Weeks of Treatment|FPG target was < 6.0 mmol / L. Nocturnal hypoglycaemia was defined as a hypoglycaemic episode happened between 00:01 and 05:59 a.m. (both included).|Week 2|Full analysis set using LOCF (Last Observation Carried Forward) included all randomised subject.||percentage (%) of subjects|||Number
686675|NCT01486966|Secondary|Percentage of Subjects Achieving Both FPG and 2hPPG Targets After Two Weeks of Treatment|FPG target was < 6.0 mmol / L, 2hPPG target was < 8.0 mmol / L.|Week 2|Full analysis set using LOCF (Last Observation Carried Forward) included all randomised subject.||percentage (%) of subjects|||Number
686676|NCT01486966|Secondary|Percentage of Subjects Achieving Mean 2hPPG of 3 Meals < 8.0 mmol / L After Two Weeks of Treatment||Week 2|Full analysis set using LOCF (Last Observation Carried Forward) included all randomised subject.||percentage (%) of subjects|||Number
686677|NCT01486966|Secondary|Percentage of Subjects Achieving FPG < 6.0 mmol / L After Two Weeks of Treatment||Week 2|Full analysis set using LOCF (Last Observation Carried Forward) included all randomised subject.||percentage (%) of subjects|||Number
686678|NCT01486966|Secondary|Change From Baseline in Mean Value of Pre-lunch, Pre-dinner and Bedtime PG After Two Weeks of Treatment|The mean value of pre-lunch, pre-dinner and bedtime PG was derived from the 8-point PG profile measured before lunch, dinner and bedtime.|Week 0, week 2|Full analysis set using LOCF (Last Observation Carried Forward) included all randomised subject. The 2 subjects who withdrew after randomisation were excluded from the efficacy analyses.||mmol/L||Standard Error|Least Squares Mean
686679|NCT01486966|Secondary|Change From Baseline in Mean 2-hour Post Prandial Plasma Glucose (2hPPG) of 3 Meals After Two Weeks of Treatment|The mean 2hPPG was derived from the 8-point PG profile as the mean value of the available 120 minutes after each meal.|Week 0, week 2|Full analysis set using LOCF (Last Observation Carried Forward) included all randomised subject. The 2 subjects who withdrew after randomisation were excluded from the efficacy analyses.||mmol/L||Standard Error|Least Squares Mean
686680|NCT01486966|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) After Two Weeks of Treatment|The FPG referred to pre-breakfast plasma glucose.|Week 0, week 2|Full analysis set using LOCF (Last Observation Carried Forward) included all randomised subject. The 2 subjects who withdrew after randomisation were excluded from the efficacy analyses.||mmol/L||Standard Error|Least Squares Mean
686681|NCT01486966|Primary|Change From Baseline in Mean 8-point Plasma Glucose (PG) After Two Weeks of Treatment|Mean value of 8-point PG was the arithmetic mean of all 8 time-instant PG values of the 8-point PG profile.|Week 0, week 2|Full analysis set using LOCF (Last Observation Carried Forward) included all randomised subject. The 2 subjects who withdrew after randomisation were excluded from the efficacy analyses.||mmol/L||Standard Error|Least Squares Mean
686682|NCT01486927|Other Pre-specified|AUC0-∞ (Part 3)|AUC0-∞ (AUC from 0 extrapolated to infinity) of an initial and repeat infusion of rVIII-SingleChain without correction for subject's predose plasma FVIII activity.|Before infusion and at up to 12 time points within 96 hours of infusion|||IU*h/dL||Standard Deviation|Mean
686683|NCT01486927|Other Pre-specified|Cmax (Part 3)|Cmax of an initial and repeat infusion of rVIII-SingleChain with correction for subject's predose plasma FVIII activity.|Before infusion and at up to 12 time points within 96 hours of infusion|||IU/dL||Standard Deviation|Mean
686684|NCT01486927|Other Pre-specified|Tmax (Part 3)|Tmax = time of Cmax (with correction for subject's predose plasma FVIII activity) after an initial and repeat infusion of rVIII-SingleChain.|Before infusion and at up to 12 time points within 96 hours of infusion.|||hours||Full Range|Median
686685|NCT01486927|Other Pre-specified|Half-life (t1/2) (Part 3)|Half-life (t1/2) of an initial and repeat infusion of rVIII-SingleChain without correction for subject's predose plasma FVIII activity.|Before infusion and at up to 12 time points within 96 hours of infusion.|||hours||Standard Deviation|Mean
686686|NCT01486927|Other Pre-specified|Mean Residence Time (MRT) (Part 3)|Mean residence time (MRT) of an initial and repeat infusion of rVIII-SingleChain without correction for subject's predose plasma FVIII activity.|Before infusion and at up to 12 time points within 96 hours of infusion.|||hours||Standard Deviation|Mean
686687|NCT01486927|Other Pre-specified|Clearance (Cl) (Part 3)|Clearance (Cl) of an initial and repeat infusion of rVIII-SingleChain without correction for subject's predose plasma FVIII activity.|Before infusion and at up to 12 time points within 96 hours of infusion.|||mL/h/kg||Standard Deviation|Mean
686688|NCT01486927|Other Pre-specified|Volume of Distribution at Steady-state (Vss) (Part 3)|Volume of distribution at steady-state (Vss) of an initial and repeat infusion of rVIII-SingleChain without correction for subject's predose plasma FVIII activity.|Before infusion and at up to 12 time points within 96 hours of infusion.|||mL/kg||Standard Deviation|Mean
686689|NCT01486927|Other Pre-specified|Incremental Recovery (Part 3)|Incremental recovery of an initial and repeat infusion of rVIII-SingleChain with correction for subject's predose plasma FVIII activity.|At 30 minutes after infusion|||[IU/dL]/[IU/kg]||Standard Deviation|Mean
686690|NCT01486927|Secondary|Proportion of Bleeding Episodes Requiring 1, 2, 3 or > 3 Infusions of rVIII-SingleChain to Achieve Hemostasis|Percentage of bleeding episodes requiring 1, 2, 3 or > 3 infusions of rVIII-SingleChain to achieve hemostasis. The denominator includes all treated bleeding episodes.|During the study (up to 24 months; assessed at Months 1, 2, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24)|||Percentage of bleeding episodes|Participants||Number
686693|NCT01486927|Secondary|Volume of Distribution at Steady-state (Vss) (Part 1)|Volume of distribution at steady-state (Vss) of a single infusion of octocog alfa and rVIII-SingleChain without correction for subject's predose plasma FVIII activity. FVIII activity values for octocog alfa are dose-adjusted for chromogenic potency.|Before infusion and at up to 10 time points within 72 hours of infusion|||mL/kg||Standard Deviation|Mean
686694|NCT01486927|Secondary|Clearance (Cl) (Part 1)|Clearance (Cl) of a single infusion of octocog alfa and rVIII-SingleChain without correction for subject's predose plasma FVIII activity. FVIII activity values for octocog alfa are dose-adjusted for chromogenic potency.|Before infusion and at up to 10 time points within 72 hours of infusion|||mL/h/kg||Standard Deviation|Mean
686695|NCT01486927|Secondary|Mean Residence Time (MRT) (Part 1)|Mean residence time (MRT) of a single infusion of octocog alfa and rVIII-SingleChain without correction for subject's predose plasma FVIII activity.|Before infusion and at up to 10 time points within 72 hours of infusion|||hours||Standard Deviation|Mean
686696|NCT01486927|Secondary|Half-life (t1/2) (Part 1)|Half-life (t1/2) of a single infusion of octocog alfa and rVIII-SingleChain without correction for subject's predose plasma FVIII activity.|Before infusion and at up to 10 time points within 72 hours of infusion.|||hours||Standard Deviation|Mean
686697|NCT01486927|Secondary|Tmax (Part 1)|Tmax = time of Cmax (with correction for subject's predose plasma FVIII activity) after a single infusion of octocog alfa and rVIII-SingleChain.|Before infusion and at up to 10 time points within 72 hours of infusion|||hours||Full Range|Median
686698|NCT01486927|Secondary|Cmax (Part 1)|Cmax of a single infusion of octocog alfa and rVIII-SingleChain with correction for subject's predose plasma FVIII activity. FVIII activity values for octocog alfa are dose-adjusted for chromogenic potency.|Before infusion and at up to 10 time points within 72 hours of infusion|||IU/dL||Standard Deviation|Mean
686699|NCT01486927|Secondary|AUC0-∞ (Part 1)|AUC0-∞ (AUC from 0 extrapolated to infinity) of a single infusion of octocog alfa and rVIII-SingleChain without correction for subject's predose plasma FVIII activity. FVIII activity values for octocog alfa are dose-adjusted for chromogenic potency.|Before infusion and at up to 10 time points within 72 hours of infusion|||IU*h/dL||Standard Deviation|Mean
686700|NCT01486927|Primary|Treatment Success During the Peri-operative Surgical Sub-study|"Subjects received rVIII-SingleChain before and during surgery based on the type of surgery and the clinical status of the subject. The investigator rated the efficacy of the treatment based on a 4-point surgical treatment rating scale of excellent, good, moderate or poor/no response. Efficacy ratings of excellent or good were considered treatment success for this end point. The rate of success, defined as the percentage of surgeries with a rating of excellent or good for hemostatic efficacy on the surgical treatment scale is presented for the Surgical Population, based on the total number of surgeries (N=16) as denominator."|From the start of surgery through the post-operative recovery (generally up to 14 days after surgery)|||% of surgeries with successful treatment|||Number
686701|NCT01486927|Primary|Annualized Spontaneous Bleeding Rate|The annualized spontaneous bleeding rate (AsBR) was derived for each subject as follows: 365.25*(number of spontaneous bleeding episodes requiring treatment) / (observed treatment period of interest).|Up to 24 months|||Number of spontaneous bleeds per year||Inter-Quartile Range|Median
686702|NCT01486927|Primary|Inhibitor Formation to FVIII|Number of subjects who develop inhibitors to FVIII|Up to 24 months|||participants|||Number
686703|NCT01486927|Primary|Treatment Success|"The investigator rated the efficacy of the treatment based on a 4-point rating scale excellent, good, moderate or poor/no response. Efficacy ratings of excellent or good were considered treatment success for this end point; the percentage of bleeding events with a rating of excellent or good and the 95% confidence interval are presented. The denominator includes all treated bleeding events. The 95% confidence interval is based on a model to account for within-subject correlation."|Up to 24 months|||% bleeding events successfully treated|Participants|95% Confidence Interval|Number
686704|NCT01486758|Secondary|Proportion of Participants With a Physician Diagnosis of Asthma|The proportion of participants with a physician diagnosis of asthma|Week 3-52|||Percentage of participants|||Number
686705|NCT01486758|Secondary|Number of Children Who Were Prescribed Inhaled Corticosteroids||3-52 weeks following randomization|||Number of participants|||Number
686706|NCT01486758|Secondary|Respiratory Symptoms Following RSV Bronchiolitis|Number of days with respiratory symptoms (cough, wheeze, or shortness of breath)|3-52 weeks following randomization|||Number of days||Standard Deviation|Mean
686707|NCT01486758|Secondary|Likelihood to Develop 3 or More Wheezing Episodes|Likelihood to develop 3 or more wheezing episodes measured by a Kaplan-Meier survival analysis|Week 3-52|A Kaplan-Meier survival analysis was conducted to compare the likelihood of developing a third episode of wheezing among participants who received azithromycin versus those who received placebo.||percentage of participants|||Number
686708|NCT01486758|Secondary|Rates of Drug Related GI Side Effects.||One month from randomization|||Number of participants|||Number
686709|NCT01486758|Secondary|Concentrations of IL-8 in Nasal Lavage on Day 15||Day 15|||pg/ml||Inter-Quartile Range|Median
686710|NCT01486758|Primary|Proportion of Participants Who Experience Subsequent Recurrent (≥2) Wheezing Episodes|Clinical outcome: The difference in the proportion of participants who experience subsequent recurrent (≥2) wheezing episodes among infants treated with azithromycin and those treated with placebo.|3-52 weeks following randomization|||Proportion of participants|||Number
686711|NCT01486758|Primary|IL-8 Concentrations|Biological outcome: The difference in IL-8 concentrations, measured in serum on day 8 after randomization, among infants treated with azithromycin and those treated with placebo.|Day 8|||Pg/ml||Inter-Quartile Range|Median
686712|NCT01486615|Secondary|Number of Patients With Loss of Memory for Being Transferred to Operating Room.|Patients were asked whether they recalled the event of being transferred to the operating room before anaesthesia. The lesser the number of patients with amnesia, the better the outcome.|24 hour after surgery|||Participants|||Number
686738|NCT01485991|Secondary|Percentage of Participants With Viral Relapse|Participants are considered to have a viral relapse if both conditions as specified are met: 1) <25 IU/mL undetectable HCV RNA at the actual end of study drug treatment; 2) confirmed HCV RNA greater than or equal to (>=) 25 IU/mL during follow-up.|End of Treatment (Week 48) up to Follow-up Period (until Week 72)|ITT population included all randomized participants who took at least 1 dose of study drug. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||percentage of participants|||Number
686713|NCT01486615|Primary|Change in VAS Anxiety Score Relative to Baseline at One Hour After Premedication|VAS (Visual Analogue Score) Anxiety Scale is a 10 cm long scale with two sides, the patient side (front) and the clinicians side (back). The extremes of the front are colored as white and black with a gradual darkening of color from white to black. The back is marked in centimeter from 0 to 10 and 0 correlates with white color (no anxiety at all) and 10 correlates to black color (anxiety as bad as ever can be) on the front. As anxiety is worsened, the color is darker and score is more. The maximum score is 10 and minimum 0. The patient is asked to point on the scale according to his anxiety level. The anxiety score is the correlating number on the clinicians side. The more the reduction in anxiety from baseline, the better the outcome.|Changes from baseline in VAS anxiety score at one hour after premedication|||Centimeter||Standard Deviation|Mean
686714|NCT01486615|Primary|Change in VAS Anxiety Score Relative to Baseline at 30 Minutes After Premedication|VAS (Visual Analogue Score) Anxiety Scale is a 10 cm long scale with two sides, the patient side (front) and the clinicians side (back). The extremes of the front are colored as white and black with a gradual darkening of color from white to black. The back is marked in centimeter from 0 to 10 and 0 correlates with white color (no anxiety at all) and 10 correlates to black color (anxiety as bad as ever can be) on the front. As anxiety is worsened, the color is darker and score is more. The maximum score is 10 and minimum 0. The patient is asked to point on the scale according to his anxiety level. The anxiety score is the correlating number on the clinicians side. The more the reduction in anxiety from baseline, the better the outcome.|Changes from baseline in VAS anxiety score at 30 minutes after premedication|||centimeter||Standard Deviation|Mean
686715|NCT01486615|Secondary|Amount of Propofol Consumption|Dose of propofol needed for loss of response to verbal command was noted at the time of induction of general anesthesia. The lesser the propofol needed for the loss of response to verbal command, the better the outcome.|1 - 2 hour after premedication|||mg||Standard Deviation|Mean
686716|NCT01486615|Secondary|Number of Patients With Intact Memory|Number of patients who recalled or recognized the picture number five shown one hour after premedication. The more the number of patients with intact memory, the better the outcome.|24 hour after surgery|||Participants|||Number
686717|NCT01486615|Secondary|Orientation Score|Orientation was assessed with a 3 point scale (0=none, 1=orientation in either time or place, 2=orientation in both). Minimum score is 0 and maximum is 2. The lesser the score, the lesser the effect on patients cognition and the better the outcome.|Orientation score at one hour after premedication|||units on a scale||Inter-Quartile Range|Median
686718|NCT01486615|Secondary|Sedation Score at One Hour After Premedication|Sedation level was assessed with a 5 point scale (0=alert, 1=arouses to voice, 2=arouses with gentle tactile stimulation, 3=arouses with vigorous tactile stimulation, 4=lack of responsiveness). Minimum score is 0 and Maximum is 4. The lesser the score, the better the outcome.|Sedation score at 1 hour after the premedication|||units on a scale||Inter-Quartile Range|Median
686719|NCT01486615|Primary|Change in VAS Anxiety Score Relative to Baseline After Premedication|VAS (Visual Analogue Score) Anxiety Scale is a 10 cm long scale with two sides, the patient side (front) and the clinicians side (back). The extremes of the front are colored as white and black with a gradual darkening of color from white to black. The back is marked in centimeter from 0 to 10 and 0 correlates with white color (no anxiety at all) and 10 correlates to black color (anxiety as bad as ever can be) on the front. As anxiety is worsened, the color is darker and score is more. The maximum score is 10 and minimum 0. The patient is asked to point on the scale according to his anxiety level. The anxiety score is the correlating number on the clinicians side. The more the reduction in anxiety from baseline, the better the outcome.|Change from baseline in VAS anxiety score at 15 minutes after premedication|sample size of 16 patients in each group was determined by a power analysis (α, 0.05; β, 0.10) assuming that there will be 50% reduction in anxiety VAS from baseline in the experimental groups and 4% in the placebo group. To compensate for dropout cases and shifting from normality in data distribution, 20 cases were studied in each group.||Centimeter||Standard Deviation|Mean
686720|NCT01486446|Other Pre-specified|Sleep Interference Due to Pain in Treatment Period 2, Compared to Baseline|"During Baseline and Treatment Period 2, subjects recorded sleep interference scores in their diary cards for each night (scores were recorded upon waking).
Sleep Interference due to pain is scored using an 11 point numerical rating scale where 0 = pain does not interfere with sleep and 10 = completely interferes, unable to sleep due to pain.
A lower sleep interference score compared to Baseline indicates that the subjects' pain interfered with sleep less on treatment than during Baseline."|Baseline to 14 or 21 days|||Percentage of Baseline||Inter-Quartile Range|Mean
686721|NCT01486446|Other Pre-specified|Daily Pain (Maximum Pain Intensity) in Treatment Period 2, Compared to Baseline|"During Baseline and Treatment Period 2, subjects recorded pain scores in their diary cards 3 times each day (upon waking, lunchtime and evening).
On each recording occasion, subjects recorded the maximum pain experienced since the previous recording occasion using an 11 point numerical rating scale of pain intensity, PINRS (where 0 = no pain and 10 = worst pain imaginable).
A lower score compared to Baseline indicates that the subjects experienced less severe pain on treatment than during Baseline."|Baseline to 14 or 21 days|||Percentage of Baseline||Inter-Quartile Range|Mean
686722|NCT01486446|Other Pre-specified|Time to Moderate Pain (Minutes) During Standard Heat Inductions in Treatment Period 2, Compared to Baseline|"A standard heat induction was performed on multiple occasions pre-and post treatment. Subjects placed their feet in front of an electric heater for up to 75 minutes. Subjects rated their pain intensity/severity using numerical and categorical rating scales at fixed intervals before, during and after the heating procedure.
The heating procedure continued until one of the pre-defined stopping criteria were met, or when the 75 minutes were over. Subjects could stop the procedure at any time if pain was intolerable.
A stopwatch was used to record the time the subject recorded a pain intensity numerical score of 5 or more (on a scale of 0-10). This time is known as Time to Moderate Pain.
A longer Time to Moderate Pain compared to Baseline indicates that subjects were able to tolerate the heat for a longer period when on treatment."|Baseline and 14 or 21 days|||Percentage of Baseline||Inter-Quartile Range|Mean
686766|NCT01485640|Primary|Number of Subjects With Treatment Emergent AEs, SAEs or Who Discontinued Due to AEs|Primary Safety assessments included spontaneous adverse event (AE) and serious adverse events (SAEs) monitoring.|18 months|Safety Population - subjects who took at least one dose of study medication||participants|||Number
686723|NCT01486446|Other Pre-specified|Time to Moderate Pain (Minutes) During Standard Heat Inductions in Treatment Period 1, Compared to Baseline|"A standard heat induction was performed on multiple occasions pre-and post treatment. Subjects placed their feet in front of an electric heater for up to 75 minutes. Subjects rated their pain intensity/severity using numerical and categorical rating scales at fixed intervals before, during and after the heating procedure.
The heating procedure continued until one of the pre-defined stopping criteria were met, or when the 75 minutes were over. Subjects could stop the procedure at any time if pain was intolerable.
A stopwatch was used to record the time the subject recorded a pain intensity numerical score of 5 or more (on a scale of 0-10). This time is known as Time to Moderate Pain.
A longer Time to Moderate Pain compared to Baseline indicates that subjects were able to tolerate the heat for a longer period when on treatment."|Baseline to Day 5|||Percentage of Baseline||Inter-Quartile Range|Mean
686724|NCT01486446|Other Pre-specified|Time to Exit (Minutes) From Standard Heat Inductions in Treatment Period 2, Compared to Baseline|"A standard heat induction was performed on multiple occasions pre-and post treatment. Subjects placed their feet in front of an electric heater for up to 75 minutes. Subjects rated their pain intensity/severity using numerical and categorical rating scales at fixed intervals before, during and after the heating procedure.
The heating procedure continued until one of the pre-defined stopping criteria were met, or when the 75 minutes were over. Subjects could stop the procedure at any time if pain was intolerable. A stopwatch was used to record the time the heating procedure was stopped. This time is known as Time to Exit.
A longer Time to Exit compared to Baseline indicates that subjects were able to tolerate the heat for a longer period when on treatment."|Baseline and 14 or 21 days|||Percentage of Baseline||Inter-Quartile Range|Mean
686725|NCT01486446|Primary|Average Daily Use of Cooling for Erythromelalgia-Related Pain in Treatment Period 2|"Using diary cards, subjects recorded the use of all non-pharmacological cooling methods used to relieve their erythromelalgia (EM) pain each day during Treatment Period 2.
A smaller average number of cooling uses each day in Treatment Period 2 indicates that subjects were in less pain/required less use of cooling to relieve their EM pain and vice versa."|14-21 Days|||cooling uses/day||Inter-Quartile Range|Mean
686726|NCT01486446|Other Pre-specified|Time to Exit (Minutes) From Standard Heat Inductions in Treatment Period 1, Compared to Baseline|"A standard heat induction was performed on multiple occasions pre-and post treatment. Subjects placed their feet in front of an electric heater for up to 75 minutes. Subjects rated their pain intensity/severity using numerical and categorical rating scales at fixed intervals before, during and after the heating procedure.
The heating procedure continued until one of the pre-defined stopping criteria were met, or when the 75 minutes were over. Subjects could stop the procedure at any time if pain was intolerable. A stopwatch was used to record the time the heating procedure was stopped. This time is known as Time to Exit.
A longer Time to Exit compared to Baseline indicates that subjects were able to tolerate the heat for a longer period when on treatment."|Baseline to Day 5|||Percentage of Baseline||Inter-Quartile Range|Mean
686727|NCT01486446|Other Pre-specified|Average Cooling Duration (Minutes Per Day) for EM-related Pain in Treatment Period 2|"Using diary cards, subjects recorded the use and duration of all non-pharmacological cooling methods used to relieve their EM pain each day during Treatment Period 2.
A smaller average duration of cooling each day in Treatment Period 2 indicates that subjects were in less pain/required less use of cooling to relieve their EM pain and vice versa."|14-21 Days|||minutes/day||Inter-Quartile Range|Mean
686728|NCT01486238|Secondary|Proportion of Subjects Requiring Macular Laser Treatment at Week 12 and Week 24.|"There is a possibility that some subjects may not respond to the study treatment to which they have been assigned. Macular laser treatment is considered an alternative treatment for retinal edema. A lower proportion of subjects requiring macular laser treatment would indicate a superior treatment regimen.
This will be assessed at week 12, and again at week 24."|24 weeks||||||
686729|NCT01486238|Secondary|Mean Change From Baseline at Week 24 in Central Foveal Thickness|Optical Coherence Tomography (OCT) will be used to assess the central foveal thickness of each patient. The mean change from baseline to week 24 will be calculated for each patient.|24 Weeks||||||
686730|NCT01486238|Primary|Proportion of Subjects Who Gain Two or More Lines in Best Corrected Visual Acuity(BCVA) Score in the Study Eye Compared With Baseline.|The primary efficacy outcome measure is the proportion of subjects who gain two or more lines in BCVA score in the Study Eye compared with baseline at 24 weeks. The BCVA is to be measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol.|24 weeks|Proportion of subjects who gain two or more lines BCVA was calculated.||participants|||Number
686731|NCT01486199|Secondary|Mucociliary Clearance Rate|Mucociliary clearance rate measured 80 minutes after radiopharmaceutical inhalation. Mucociliary clearance rate is the rate of clearance of Technetium sulfur colloid (Tc-SC) from the lungs.|t=2 years, measure made 80 minutes after radiopharmaceutical inhalation|Only pediatric CF subjects performed 2 year follow-up scan. One subject did not perform the second imaging day since day one image quality was poor. Two other subjects had poor imaging data on follow up day and were therefore not included in analysis.||percent cleared / 80 minutes||Standard Deviation|Mean
686732|NCT01486199|Secondary|Absorptive Clearance Rate|Absorptive Clearance Rate measured 80 minutes after radiopharmaceutical inhalation. Absorptive clearance is the absorptive component of the clearance of In-DTPA from the lungs.|t=2 years|Only pediatric CF subjects performed 2 year follow-up scan. One subject did not perform the second imaging day since day one image quality was poor. Two other subjects had poor imaging data on follow up day and were therefore not included in analysis.||percent cleared / 80 min||Standard Deviation|Mean
686733|NCT01486199|Primary|Mucociliary Clearance Rate|Mucociliary clearance rate measured 80 minutes after radiopharmaceutical inhalation. Mucociliary clearance rate is the rate of clearance of Technetium sulfur colloid (Tc-SC) from the lungs.|study day 1|One pediatric subject did not deposit sufficient aerosol to be analyzed. One control subject did not perform imaging procedures after signing consent because of a low result on a screening pulmonary function testing.||percent cleared / 80 minutes||Standard Deviation|Mean
686734|NCT01486199|Primary|Absorptive Clearance Rate|Absorptive clearance rate measured 80 minutes after radiopharmaceutical inhalation. Absorptive clearance is the absorptive component of the clearance of Indium 111-diethylenetriaminepentaacetic acid (In-DTPA) from the lungs.|study day 1|One pediatric subject did not deposit sufficient aerosol to be analyzed. One control subject did not perform imaging procedures after signing consent because of a low result on a screening pulmonary function testing.||percent cleared / 80 minutes||Standard Deviation|Mean
686739|NCT01485991|Secondary|Percentage of Participants With Sustained Virologic Response 24 Weeks After the Planned End of Treatment (SVR24)|Participants are considered to have reached SVR24 if both conditions below are met: 1) HCV RNA levels less than <25 International unit per milliliter (IU/mL) undetectable (at the actual end of treatment);2) HCV RNA levels <25 IU/mL undetectable or HCV RNA levels <25 IU/mL detectable (24 weeks after the planned EOT).|24 Weeks After the Planned EOT (Week 48)|ITT population included all randomized participants who took at least 1 dose of study medication.||percentage of participants|||Number
686740|NCT01485991|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12)|Participants are considered to have reached SVR12 if both conditions below are met: 1) HCV RNA levels less than (<) 25 International unit per milliliter (IU/mL) undetectable; 2) HCV RNA levels <25 IU/mL undetectable or HCV RNA levels <25 IU/mL detectable.|12 Weeks After the Planned End of Treatment (EOT: Week 48)|Intent-to-treat (ITT) population included all randomized participants who took at least 1 dose of study medication.||percentage of participants|||Number
686741|NCT01485887|Secondary|Change From Baseline in 16-item Quick Inventory of Depressive Symptomatology Self-Report Japanese Version (QIDS16-SR-J) at Each Post Baseline Time Point|QIDS16-SR-J is a self-rated scale used in patients with major depressive disorder to measure the overall severity of depressive symptoms: 1) sad mood; 2) concentration; 3) self-criticism; 4) suicidal ideation; 5) interest; 6) energy/fatigue; 7) sleep disturbance (initial, middle, and late insomnia or hypersomnia); 8) decrease/increase in appetite/weight; and 9) psychomotor agitation/retardation. QIDS16-SR-J items are rated on a scale of 0 to 3, and the total score ranges from 0 to 27. Higher scores indicate more severe symptoms. Change from baseline: mean score at observation minus mean score at baseline.|Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]), Weeks 12, 24, 44|Participants who recieved at least one dose of study drug in this study , and had at least one evaluable HAM-D17 score and QIDS16-SR-J score after Week 8 of the preceding study B2411263 (NCT01441440). 'n' is signifying those participants who were evaluated for this measure at each time point.||Units on a scale||Standard Deviation|Mean
686742|NCT01485887|Secondary|Mean Clinical Global Impression - Improvement (CGI-I) Score at Each Post Baseline Time Point|CGI-I is a 7-point clinician rated scale ranging from 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, to 7=very much worse. Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Scores above 4 reflect worsening of illness state as compared to baseline.|Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44|Participants who recieved at least one dose of study drug in this study , and had at least one evaluable HAM-D17 score after Week 8 of the preceding study B2411263 (NCT01441440). 'n' is signifying those participants who were evaluated for this measure at each time point.||Units on a scale||Standard Deviation|Mean
686743|NCT01485887|Secondary|Change From Baseline in Clinical Global Impression - Severity (CGI-S) at Each Post Baseline Time Point|CGI-S is a 7-point clinician rated scale to assess severity of participant's current illness state; range: 1=normal, not ill at all, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill patients. Higher scores reflect higher severity of current illness states. Change from baseline: mean score at observation minus mean score at baseline.|Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]), Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44|Participants who recieved at least one dose of study drug in this study , and had at least one evaluable HAM-D17 score after Week 8 of the preceding study B2411263 (NCT01441440). 'n' is signifying those participants who were evaluated for this measure at each time point.||Units on a scale||Standard Deviation|Mean
686744|NCT01485887|Secondary|Change From Baseline in 17-item Hamilton Rating Scale for Depression (HAM-D17) at Each Post Baseline Time Point|HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, work and activities, sleep, suicide, psychomotor agitation/retardation, appetite, sexual interest, anxiety, and somatic symptoms). The items of the HAM-D17 are rated on a scale of 0 to 2 (8 items) or 0 to 4 (9 items), and the total score ranges from 0 to 52. Higher scores indicate more severe symptoms. Change from baseline: mean score at observation minus mean score at baseline.|Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]), Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44|Participants who recieved at least one dose of study drug in this study , and had at least one evaluable HAM-D17 score after Week 8 of the preceding study B2411263 (NCT01441440). 'n' is signifying those participants who were evaluated for this measure at each time point.||Units on a scale||Standard Deviation|Mean
686745|NCT01485887|Primary|Number of Participants With no at Baseline and Yes at Any Post Baseline for Columbia Suicide-Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories|C-SSRS is a participant rated questionnaire to assess suicidal ideation, suicidal behavior, actual attempts (yes or no responses), and intensity of ideation (rated 1=low severity to 5=high severity). Yes/No responses are mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) categories: Completed suicide, suicide attempt, preparatory acts toward imminent suicidal behavior, suicidal ideation, and self-injurious behavior, or no suicidal intent. A participant could have a yes or no response in more than one category.|Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months|Participants who received at least one dose of the study drug.||Participants|||Number
686746|NCT01485887|Primary|Number of Participants With Clinical Significant Electrocardiogram (ECG) Changes|Clinically significant ECG findings included: corrected QT (QTc), QT interval corrected using the Bazett's formula (QTcB), and QT interval corrected using the Fridericia formula (QTcF)> 450 millisecond (ms), >480 ms, and >500 ms respsctively, change from baseline in QTc, QTcB, and QTcF >= 30 ms, and >= 60 ms, respectively.|Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months|Participants with at least one observation of the electrocardiogram while on study treatment.||Participants|||Number
686767|NCT01485536|Primary|Overall Response Rate (ORR)|Percentage of participants with objective response defined as Complete (CR) and Partial (PR) Response. Computed tomography (CT) and Positron emission tomography (PET) scans done after every 2 cycles to assess efficacy using Cheson Criteria (2007) which lists CR as disappearance of all evidence of disease, and PR as regression of measurable disease and no new sites.|Up to 12 cycles or 48 weeks|One participant withdrew therefore was not evaluable for the outcome and is excluded from analysis||percentage of participants|||Number
686747|NCT01485887|Primary|Number of Participants With Clinical Significant Laboratory Tests Changes|Clinical significant changes were pre-defined for each laboratory test based on the criteria: Red Blood Cell Count <0.8 x lower limit normal (LLN); Lymphocytes (%) <0.8 x LLN; Eosinophils (%) >1.2 x upper limit normal (ULN); Total Bilirubin >1.5 x ULN; Alanine Aminotransferase (ALT) >3.0 x ULN; Gamma glutamyl transferase (GGT) >3.0 x ULN; Uric Acid >1.2 x ULN; Cholesterol >1.3 x ULN; Low density lipoprotein (LDL) cholesterol >1.2 x ULN; Triglycerides >1.3 x ULN; Glucose >1.5 x ULN; Urine Glucose [qualitative (Qual)] >=1; Urine Protein (Qual) >=1; Urine Blood/Hemoglobin (Hgb) (Qual) >=1.|Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months|Participants with at least one observation of the given laboratory test while on study treatment or during lag time.||Participants|||Number
686748|NCT01485887|Primary|Number of Participants With Clinical Significant Vital Changes|Clinical significant changes were pre-defined for systolic blood pressure (SBP), diastolic blood pressure (DBP) , and pulse rate (PR). An average value of 3 measurements in each visit meeting the following criteria for 3 consecutive visits was determined as clinical siginificant changes: DBP >= 90 mmHg with change from the baseline >= 10 mmHg; SBP >= 140 mmHg with change from the baseline >= 20 mmHg; PR >= 100 bpm with change from the baseline >= 15 bpm.|Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months|Participants who received at least one dose of the study drug.||Participants|||Number
686749|NCT01485887|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|Any untoward medical occurrence in a participant who received study drug was considered an adverse event (AE), without regard to possibility of causal relationship. Treatment-emergent adverse events: those which occurred or worsened after baseline. An AE resulting in any of the following outcomes, was considered to be a serious adverse event: death; lifethreatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect.|Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months|Participants who recieved at least one dose of the study drug.||Participants|||Number
686765|NCT01485640|Secondary|Change From Baseline to Month 18 (LOCF) in the Clinical Global Impression Severity Score (CGI-S|The CGI-S score is a single value, clinician-rated assessment of illness severity and ranges from 1= ‘Normal, not at all ill’ to 7= ‘Among the most extremely ill patients’. A higher score is associated with greater illness severity.|18 months|Only 153 subjects who had baseline and at least one post-baseline assessments.||units on a scale||Standard Deviation|Mean
686768|NCT01485536|Primary|Objective Response in Participants With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL) and Peripheral T-cell Lymphoma (PTCL)|Objective Response defined as Complete (CR) and Partial (PR) Response. Computed tomography (CT) and Positron emission tomography (PET) scans done after every 2 cycles to assess efficacy using Cheson Criteria (2007) which lists CR as disappearance of all evidence of disease, and PR as regression of measurable disease and no new sites.|56 days|One participant withdrew therefore was not evaluable for the outcome and is excluded from analysis||Participants|||Count of Participants
686769|NCT01485380|Primary|Number of Participants With Changes in the Brains Default Mode Network.|Number of participants with changes in the Default Mode network during loss and recovery of consciousness under dexmedetomidine induced sedation versus baseline as assessed by changes in blood oxygen level depended (BOLD) signals during the awake, unconscious, and recovery states.|1.5hrs|All 17 participants were analyzed. Blood oxygen level depended (BOLD) signals during the awake (n = 16), unconscious (n = 16), and recovery (n = 15) states were included in the final data set.||participants|||Number
686770|NCT01485354|Secondary|Change in Grip Strength (Strength Test) (i.e. Difference Between Grip Strength at Baseline and at Completion of the 3-week Intervention)|This test is carried out by using a hand dynamometer that measures the grip strength of the individual in kilograms (used as a measure of force). Subjects are instructed to position the thumb on one handle of the dynamometer and the other fingers on the other handle of the dynamometer. The device measures the force generated by the subject using a power grip. The investigators computed the difference between the Grip Strength value at completion of the 3-week intervention and the Grip Strength value at baseline.|Data collected at baseline and at completion of the 3-week intervention|Please notice that we recruited 17 subjects, but 5 subjects withdrew from the study. Herein, we report the results for those subjects who completed the study.||kg||Standard Deviation|Mean
686771|NCT01485354|Secondary|Change in Box and Block Test Score (Manual Dexterity Test) (i.e. Difference Between Box and Block Test Score at Baseline and at Completion of the 3-week Intervention)|The Box and Block test is designed to assess manual dexterity in subjects with motor impairments. Subjects are asked to move small wooden blocks from one box to another, moving their stroke-affected arm over a divider between the two boxes. The output of the test is the number of blocks that the subject moves from one box to the other within a set amount of time (i.e. 1 min). Older adults who are otherwise healthy would typically move 60 to 70 blocks in 1 min. Hence, the range of the scale for older adults is 0 to 70. The investigators computed the difference between the Box and Block Test score at completion of the 3-week intervention and the Box and Block Test score at baseline.|Data collected at baseline and at completion of the 3-week intervention|Please notice that we recruited 17 subjects, but 5 subjects withdrew from the study. Herein, we report the results for those subjects who completed the study.||number of blocks||Standard Deviation|Mean
686772|NCT01485354|Secondary|Change in Functional Ability Scale Score (Scale to Rate Quality of Movement) (i.e. Difference Between Functional Ability Scale Score at Baseline and at Completion of the 3-week Intervention)|The Functional Ability Scale is designed to assess the quality of movement during the performance of a battery of functional tasks. Therapists observe the subject while performing the motor tasks and use an ordinal scale to rate the quality of movement. The scale used to rate each motor task ranges from 0 to 5. The Functional Ability Scale is derived by adding up the scores for each motor task performed by the subject. Subjects perform 15 motor tasks. Hence the Functional Ability Scale score varies from 0 (very poor quality of movement) to 75 (physiological movement). The investigators computed the difference between the Functional Ability Scale score at completion of the 3-week intervention and the Functional Ability Scale score at baseline.|Data collected at baseline and at completion of the 3-week intervention|Please notice that we recruited 17 subjects, but 5 subjects withdrew from the study. Herein, we report the results for those subjects who completed the study.||units on a scale||Standard Deviation|Mean
686773|NCT01485354|Secondary|Change in Wolf Motor Function Test Score (a Functional Test) (i.e. Difference Between Wolf Motor Function Test Score at Baseline and at Completion of the 3-week Intervention)|The Wolf Motor Function test is designed to assess the severity of functional limitations in stroke survivors. The scale is administered by asking subjects to perform a series of functional movements (e.g. reach for and pick up a paperclip). The outcome of the assessment is the average time needed to perform the motor tasks that are part of the assessment. The score ranges from 0 to 120 s (i.e. if the subject is unable to perform the task, the score for that task is set to 120 s). The investigators computed the difference between the Wolf Motor Function Test score at completion of the 3-week intervention and the Wolf Motor Function Test score at baseline.|Data collected at baseline and at completion of the 3-week intervention|Please notice that we recruited 17 subjects, but 5 subjects withdrew from the study. Herein, we report the results for those subjects who completed the study.||sec||Standard Deviation|Mean
686774|NCT01485354|Primary|Change in Upper-extremity Fugl-Meyer Score (Measure of Motor Impairment) (i.e. Difference Between Fugl-Meyer Score at Baseline and at Completion of the 3-week Intervention)|The upper-extremity Fugl-Meyer scale allow one to assess the severity of motor impairments in stroke survivors using a scale from 0 (severe impairment) to 66 (no impairment). It is based on visual observations gathered by asking subjects to perform upper-limb movements using the stroke-affected limb. Therapists rate the performance of the motor tasks using an ordinal scale ranging from 0 (cannot perform) to 2 (can perform fully) that captures the motor ability of the individual. The investigators computed the difference between the Fugl-Meyer score at completion of the 3-week intervention and the Fugl-Meyer score at baseline.|Data collected at baseline and at completion of the 3-week intervention|Please notice that we recruited 17 subjects, but 5 subjects withdrew from the study. Herein, we report the results for those subjects who completed the study.||units on a scale||Standard Deviation|Mean
686775|NCT01485172|Secondary|Percentage of Participants Withdrawn From the Study Due to Lack of Efficacy|The percentage of participants who withdrew from the study due to lack of efficacy as defined by either the participant or the investigator is presented here.|Up to Week 4 of the Maintenance Period (Study Week 17)|ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed||Percentage of participants|||Number
686928|NCT01483924|Secondary|Efficacy of APO805K1 as Assessed by Achievement of PASI-75|The proportion of patients in each treatment group who achieved at least a 75% improvement in PASI score from baseline at Week 12|12 weeks|The Efficacy Population was defined as all patients who received at least 1 dose of study medication and completed at least 1 post-baseline efficacy assessment.||percentage of patients|||Number
686776|NCT01485172|Secondary|Responder Rate According to the Clinical Global Impression – Global Improvement (CGI-I) Scale|"The CGI-I scale allows the investigator to rate the participant's total improvement since the beginning of treatment (Baseline). Baseline is defined as the last non-missing assessment measured on or before the first dose date. The scale is rated from 1-7 where 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. The responder rate is defined as the percentage of participants with a score of 1 or 2."|Week 4 of the Maintenance Period (Study Week 17)|ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed||Percentage of participants|||Number
686777|NCT01485172|Secondary|Change From Baseline in the UPDRS Part I (Mentation)|"The UPDRS Part I scores mentation, behavior and mood as determined by a physician and participants were tested during the on phase of Parkinson's. This component of the UPDRS is the total score for 4 items (the items 1- 4 include intellectual impairment, thought disorder, motivation/initiative, and depression) and may have a value ranging from 0 to 16 as determined by a physician where 16 indicates the maximum score and the worse condition. All 4 items have to be present for a total score to be calculated. If one or more items are missing, the total score for the component will also be missing. Baseline is defined as the last non-missing assessment measured on or before the first dose date. The change from Baseline will be calculated by subtracting the Baseline values from the individual post-randomization values."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed||Score on a scale||95% Confidence Interval|Least Squares Mean
686778|NCT01485172|Secondary|Change From Baseline in the Total UPDRS Score (Parts I-III)|"The total UPDRS score was calculated by the sum of the values for each component (Part I + Part II + Part III) as determined by the physician. The UPDRS Part I scores mentation, behavior and mood and scores can range from 0-16. The UPDRS Part II is the Activities of Daily Living (ADL) score and can range from 0-52. The UPDRS Part III is the Motor Examination (Total Motor Score [TMS]) and scores range from 0-108. The total UPDRS (Part I + II + III) scores can range from 0-176 with the higher score indicating the worse condition. Tests were performed when the participant is in the on state of Parkinson's. Baseline is defined as the last non-missing assessment measured on or before the first dose date. The change from Baseline will be calculated by subtracting the Baseline values from the individual post-randomization values."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed||Score on a scale||95% Confidence Interval|Least Squares Mean
686779|NCT01485172|Secondary|Change From Baseline in UPDRS Activities of Daily Living|"The UPDRS Part II is the Activities of Daily Living (ADL) score and can range from 0-52 as determined by the physician. The higher score indicates the worse condition. Tests were performed when the participant is in the on state of Parkinson's. Baseline is defined as the last non-missing assessment measured on or before the first dose date. The change from Baseline will be calculated by subtracting the Baseline values from the individual post-randomization values."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed||Score on a scale||95% Confidence Interval|Least Squares Mean
686780|NCT01485172|Secondary|Change From Baseline in UPDRS Parts II and III Combined|"The UPDRS Part II is the Activities of Daily Living (ADL) score and can range from 0-52 as determined by the physician. The UPDRS Part III is the Motor Examination (Total Motor Score [TMS]) and is defined as the total score, ranging from 0-108 as determined by the physician, of the tests given in the motor examination section. The combined scores of Parts II and III can range from 0-160 with the higher score indicating the worse condition. Tests were performed when the participant is in the on state of Parkinson's. Baseline is defined as the last non-missing assessment measured on or before the first dose date. The change from Baseline will be calculated by subtracting the Baseline values from the individual post-randomization values."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed||Scores on a scale||95% Confidence Interval|Least Squares Mean
686781|NCT01485172|Secondary|Responder Rate Defined as Participants With a >=30% Reduction in Baseline UPDRS Motor Score|The responder rate is defined as the percentage of participants with a greater than or equal to (>=)30% reduction in their individual Baseline UPDRS motor score at Week 4 of the Maintenance Period (Study Week 17). Baseline is defined as the last non-missing assessment measured on or before the first dose date. The change from Baseline will be calculated by subtracting the Baseline values from the individual post-randomization values.|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed||Percentage of Participants|||Number
686782|NCT01485172|Secondary|Number of Participants With a >=10 Points Reduction From Baseline in UPDRS Parts II and III Combined|"The UPDRS Part II is the Activities of Daily Living (ADL) score and can range from 0-52 as determined by the physician. The UPDRS Part III is the Motor Examination (Total Motor Score [TMS]) and is defined as the total score, ranging from 0-108 as determined by the physician, of the tests given in the motor examination section. The combined scores of Parts II and III can range from 0-160 with the higher score indicating the worse condition. Tests were performed when the participant is in the on state of Parkinson's. Baseline is defined as the last non-missing assessment measured on or before the first dose date."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed||Participants|||Number
686783|NCT01485172|Secondary|Number of Participants With a >=10 Points Reduction From Baseline in UPDRS Motor Score|The UPDRS motor scores can range from 0-108 where the maximum score indicates the worse condition. Baseline is defined as the last non-missing assessment measured on or before the first dose date. The change from Baseline will be calculated by subtracting the Baseline values from the individual post-randomization values.|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed||Participants|||Number
686784|NCT01485172|Secondary|Number of Participants With a >=5 Points Reduction From Baseline in UPDRS Motor Score|The UPDRS motor scores can range from 0-108 where the maximum score indicates the worse condition. Baseline is defined as the last non-missing assessment measured on or before the first dose date. The change from Baseline will be calculated by subtracting the Baseline values from the individual post-randomization values.|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed||Participants|||Number
686785|NCT01485172|Primary|Change From Baseline (BL) in Unified Parkinson Disease (PD) Rating Scale (UPDRS) Motor Score|The UPDRS is a clinician based rating scale used to measure motor impairments and disability. The UPDRS assesses six features of PD impairment. These are evaluated using a combination of data collected by interview and examination of the participant. One of the six features include the Part III – Motor Examination where scores can range 0-108 where the maximum score indicates the worse condition. BL is defined as the last non-missing assessment measured on or before the first dose date. The change from BL was calculated by subtracting the BL values from the individual post-randomization values. The least squares(LS) means were estimated using the mixed model repeated measures(MMRM) adjusting for BL UPDRS motor score and race(white versus other) or by using the non-parametric rank analysis of covariance(ANCOVA).|Baseline and Week 4 of the Maintenance Period (Study Week 17)|Intent to Treat (ITT) Population: all randomized subjects who received at least one dose of study medication, had a Baseline efficacy assessment for the specific outcome, and had at least one respective efficacy outcome assessment collected after randomization (Baseline) visit, i.e. had at least one respective Post-Baseline efficacy assessment.||Score on a scale||95% Confidence Interval|Least Squares Mean
686786|NCT01485094|Secondary|Daily Current Pain Intensity|"Participants recorded their current pain intensity score 3 times a day, using a 0 -10 (11 point) Numeric Rating Scale where a rating of 0 corresponded to No Pain and a rating of 10 to Pain as bad as you can imagine.
The daily current pain intensity reported was derived as the mean of the 3 current pain intensity assessments taken on the day from all participants in the treatment group.
The lower the value on the 11 point scale the less pain was reported on a treatment."|Baseline; Day 10|Intent-to-Treat.||units on a scale||Standard Deviation|Mean
686787|NCT01485094|Secondary|Change in painDETECT Grading From Baseline (Day -1) to End of Double-blind Treatment (Day 7)|"The painDETECT questionnaire was used to determine the possibility of the presence of a neuropathic pain component. It is a participant completed questionnaire. A total score is calculated between 0 and 38 for each participant. Participants with a score between 0 and 12 are graded as negative and having no neuropathic pain component. Scores between 19 and 38 result in a positive grading, in other words having presence of neuropathic component. Values from 13 to 18 result in participants being graded as having an unclear neuropathic component to their pain. The painDETECT questionnaire was first administered on Day-1 (baseline). The data reported is for before treatment start (Day -1) and the change from baseline on Day 7 (end of the double-blind period)."|Day 7 (end of double blind treatment)|Intent-to-treat. 5 participants did not complete the painDETECT questionnaire on Day 7. Two participants in both the placebo and pregabalin treatment arm and 1 in the GRT6010 treatment arm.||participants|||Number
686788|NCT01485094|Secondary|Difference in Leeds Sleep Evaluation Questionnaire After 7 Days of Treatment|"On the last day of the double-blind treatment period sleep was evaluated using the Leeds sleep evaluation questionnaire. This questionnaire has 10 self-rating 100 mm line analogue questions concerning sleep and early morning behavior. The higher the score, i.e. the closer the value is to 100 the worse the rating by the participant.
The 10 responses are grouped into 4 subscores:
The ease of getting to sleep.
The perceived quality of sleep.
The ease of awakening from sleep.
The integrity of behavior following wakefulness."|Day 7|Intention-to-treat. No responses were obtained from 2 participants, one in the placebo and one in the pregabalin treatment arm.||units on a scale||Standard Deviation|Mean
686789|NCT01485094|Secondary|Change in Area of Static Allodynia and Dynamic Allodynia From Baseline|"Allodynia is pain due to a stimulus that does not normally provoke pain. To measure the areas of dynamic and static allodynia, a point lying in the center of the area of maximum pain was marked at baseline (Day -2 and -1). From the baseline point, 8 radii were drawn.
The area of dynamic allodynia was determined by gently stroking the skin with a standardized brush along the lines. The participant was asked to report when the sensation became unpleasant.
The area of static allodynia was determined by a 128 mN (millinewton) pinprick stimulus along the lines of the 8 radii while asking the subject to report when the sensation became unpleasant.
The area was calculated from the summing of the 8 triangles that are generated from the points along each of the 8 radii at which unpleasantness was reported. The larger the area in square centimeters the more allodynia. A reduction in the area of allodynia indicates improvement."|Baseline; Day 7 (end of double blind treatment)|Intent-to-treat||square centimeters||Standard Deviation|Mean
686790|NCT01485094|Secondary|The Difference Between Baseline and End-of-double-blind Treatment Scores for Dynamic Mechanical Allodynia and Mechanical Pain Sensitivity Compared to Placebo|"Allodynia is pain due to a stimulus that does not normally provoke pain. Dynamic mechanical allodynia was assessed using a set of 3 light tactile stimulators as moving innocuous stimuli.
Each participant gave numerical pain ratings for each of 15 stimuli at the affected side.
Mechanical pain sensitivity was assessed using a set of 7 weighted pinprick stimuli to obtain the stimulus–response function for pinprick-evoked pain.
The participant gave a numerical pain ratings for each of 35 pinprick stimuli at the affected site.
Dynamic mechanical allodynia and mechanical pain sensitivity was calculated as the geometric mean of all numerical ratings. The values obtained on Day -2 and -1 were taken as the baseline and values on Day 6 and 7 were taken as the end of treatment. A negative change indicates an improvement on the 0 (no pain) to 100 point scale, where 100 indicates the worst imaginable pain."|Day 7 (end of double blind treatment)|Intention-to-treat||units on a scale||Standard Deviation|Mean
686791|NCT01485094|Secondary|Difference in Patient's Global Impression of Change|In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the 7 day treatment period. The participant is requested to choose one of seven categories. Scores range from very much improved to very much worse.|Day 7 (end of double blind treatment)|Intention-to-treat||participants|||Number
686792|NCT01485094|Secondary|Change in Neuropathic Pain Symptom Inventory Scores on Day 7 From Baseline (Day -1)|"The Neuropathic Pain Symptom Inventory (NPSI) Score is an assessment of neuropathic pain symptoms.
A participant answered 10 questions on an 11-point scale 0 (no pain) to 10 (most intense pain imaginable).
The total NPSI score is the sum of all ten responses and ranges between 0 and 100.
The baseline score and the mean NPSI change is reported over the double-blind treatment period. A negative mean change in score on Day 7 indicates an improvement on this 0 to 100 point scale from baseline for the total score.
For pain descriptions burning, pressing, paroxysmal (pain like electric shocks or stabbing), evoked (due to touch) and paresthesia (sensation that is not unpleasant) or dysesthesia (unpleasant) subscores a negative mean change indicate an improvement on the 11 point scale. A participant will score 10 to indicates the worst imaginable symptom, e.g. worst burning imaginable. A participant will score 0 if there is no burning, i.e. the symptom is absent."|Day -1; Day 7 (end of double blind treatment)|intent-to-treat||units on a scale||Standard Deviation|Mean
686793|NCT01485094|Secondary|Onset of Ongoing Pain Relief|"Onset of ongoing pain relief defined as the first time-point at which the participant reports a decrease of more than 1-point reduction in ongoing pain relative to baseline (day -3 to day -1), after start of treatment with study drug on Day 1. Study drug intake started on Day 1.
Due to the early termination of the trial this analysis was not performed."|Day 1 to Day 7 (end of double blind treatment)||||||
686794|NCT01485094|Secondary|Onset of Current Pain Relief|"Onset of current pain relief defined as the first time-point at which the participant reports a decrease of a 1-point reduction in current pain relative to baseline (day -3 to day -1), after start of treatment with study drug on Day 1.
Due to the early termination of the trial this analysis was not performed."|Day 1 to Day 7 (end of double blind treatment)||||||
686795|NCT01485094|Secondary|Assessment of Responder Rates|"The assessment was performed on Day 7.
The percentage of change from baseline (Day -3 to Day -1, i.e. the 3 days in the days prior to first dose) in the daily ongoing pain intensity was calculated at Day 7.
The percentage of change from baseline in the daily ongoing pain intensity was calculated at Day 7 as follows:
% change = (Baseline Pain Intensity - Daily pain intensity at treatment visit) / Baseline Pain Intensity × 100
The threshold values represent an improvement in ongoing pain intensity greater than 20, 30, 40, 50, 60, 70, 80 or 90% as per calculation.
Participants who showed a worsening in their daily pain intensity or who prematurely discontinued the trial were regarded as non-responders in terms of the respective treatment."|Day 7 (end of double blind treatment)|||participants|||Number
686796|NCT01485094|Primary|The Difference Between Baseline and End-of-double-blind Treatment Brush-evoked Pain Intensity Scores|"The difference between baseline and end-of-double-blind treatment brush-evoked pain intensity scores compared to placebo on a 0-100 point NRS (measured as part of the dynamic mechanical allodynia assessments).
Each participant rated each brush-evoked pain intensity on a 0 to 100 point Numerical Pain Rating Scale, with 0 indicating ‘No Pain’ and 100 indicating ‘most intense pain imaginable’. Lower values compared to an individual subject’s baseline are an improvement in symptoms.
The baseline brush-evoked pain intensity score was defined as the average of the geometric mean of all of the values obtained on Day -2 and Day -1, and compared with the scores obtained on day 6 and 7.
For the analysis, only pain scores on days where participants received study drug were considered.
A negative change indicates a decrease in brush-evoked pain intensity from baseline."|Baseline and day 7 (end of double blind treatment)|||units on a scale||Standard Deviation|Mean
686797|NCT01485094|Primary|Difference Between Baseline and End-of-double-blind Treatment Ongoing Pain Intensity Scores|The baseline pain intensity score was calculated as a mean of pain intensity scores during the Baseline Period (from Day -3 to Day -1). The ongoing pain intensity data from Day-3 to Day 7 was used. For the analysis, only pain scores on days where participants received study drug were considered. The primary efficacy analysis of the ongoing pain intensity score were analyzed in a Bayesian framework, via a mono exponential decay model, with the baseline Numeric Rating Score (NRS) as intercept. Considering the inclusion criteria of baseline pain intensity being in the range from 4 to 9, the range in ongoing pain intensity difference between baseline and end-of-double-blind treatment can be from 6 (worst possible value) to -9 (best possible value). A negative value indicates improvement whilst on the treatment.|Baseline; Day 7 (end of double blind treatment)|Intention-to-treat||units on a scale||Standard Deviation|Mean
686798|NCT01484977|Primary|Retention at the End of the 21-week Treatment Period|Retention is a summary measure that integrates both the patient’s and clinician’s assessment of efficacy and tolerability in epilepsy clinical studies to provide a measure of effectiveness.|Duration of the Treatment Period (21 Weeks)|The primary analysis consists of subjects in the Safety Set (SS). The SS is all subjects who received at least 1 dose of lacosamide.||percentage of participants|||Number
686799|NCT01484951|Secondary|Percentage of Patients With Target IOP (≤18 mmHg), Regardless of Prior Therapy|As measured with Goldmann applanation tonometry. The outcome measure was pre-specified for all participants.|Week 8|Per protocol: All participants who received study medication, completed all study visits, and satisfied inclusion/exclusion criteria.||Percentage of Participants|||Number
686800|NCT01484951|Primary|Change in Intraocular Pressure (IOP) at the Final Visit From Prior Beta-blocker Monotherapy (Timolol 0.5% Only)|As measured at baseline and final visit with Goldmann applanation tonometry. The outcome measure was pre-specified for Timolol 0.5% only participants.|Baseline, Week 8|Per protocol: All participants who received study medication, completed all study visits, and satisfied inclusion/exclusion criteria.||millimeters mercury (mmHg)||Standard Deviation|Mean
686801|NCT01484938|Primary|Mean Change From Baseline (Day 0) in Total Corneal Staining Type at Day 30|Corneal staining type was assessed by the investigator for each of five regions of the cornea, i.e., four quadrants plus central. The investigator instilled flourescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and yellow filter. Corneal staining type was recorded on a 5-point scale for each region: 0=none; 1=micropunctate; 2=macropunctate; 3=coalesced macropunctate; 4=patch (>/= 1 mm). The five regions were summed, for a summed total range of 0-20.|Baseline (Day 0), Day 30|Intent to treat. All subjects who were enrolled in the study and completed at least one on-regimen study visit were evaluable for intent-to-treat analyses.||Units on a scale||Standard Deviation|Mean
686802|NCT01484938|Primary|Mean Change From Baseline (Day 0) in Average Corneal Staining Area at Day 30|Percentage corneal staining was assessed by the investigator for each of five regions of the cornea; i.e., four quadrants plus central. The investigator instilled flourescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and yellow filter. Percentage corneal staining was recorded in increments of ten, and the percentages of the five regions were averaged together.|Baseline (Day 0), Day 30|Intent to treat. All subjects who were enrolled in the study and completed at least one on-regimen study visit were evaluable for intent-to-treat analyses.||Percentage of corneal staining||Standard Deviation|Mean
686803|NCT01484912|Secondary|Consumption of Short-acting Nitrates||The consumption of short-acting nitrates from baseline (V2, Day 0) to all visits [V3 (Day 14±2), V4 (Day 28±2), V5 (Day 42±2)]according to patient's diary.|The data was not available for analysis, because only two patients administered short-acting nitrates||mg||Standard Deviation|Mean
686804|NCT01484912|Secondary|Change in Pharmacological Parameters|The level of oxidative stress parameters (isoprostane, homocysteine), homeostasis parameters (PAI-I activity), inflammatory markers (fibrinogen, hsCRP, soluble CD40 ligand) and cardiac enzymes (CPK-MB and LDH), were measured to assess the pharmacological activity of STA-2.|baseline (visit 2) to week 6 (visit 5)||||||
686805|NCT01484912|Secondary|Change in Rate-pressure Product|Rate-pressure product was defined as the product of heart rate and systolic blood pressure, which was measured both at rest and at peak of exercise.|baseline (visit 2) to week 6 (visit 5)||||||
686806|NCT01484912|Secondary|Change in Consumption of Short-acting Nitrates|The consumption of short-acting nitrates from baseline (V2, Day 0) to all visits [V3 (Day 14±2), V4 (Day 28±2), V5 (Day 42±2)]according to patient's diary.|from baseline (visit 2) through week 6 (visit 5)||||||
686807|NCT01484912|Secondary|Changes in Time to 1mm ST-segment Depression During Exercise Tolerance Testing (ETT).|Time to 1 millimeter (mm) ST-segment depression was recorded from Electrocardiogram (EKG) during exercise tolerance testing (ETT). The 1mm ST-segment depression may be seen in typical angina patient. It means the ST segment of EKG wave drops at least 1 mm compared to the beginning of EKG measurement.|baseline (visit 2) through week 6 (visit 5)|||seconds||Standard Deviation|Mean
686808|NCT01484912|Primary|Change in Total Exercise Time|Total exercise time was defined as the maximal duration of exercise which was performed by the patient in the setting of exercise tolerance tests (ETT). A 12-lead electrocardiogram (EKG) was used to continuously monitor vital signs. Patients were asked to complete 9-12 minutes of exercise or to exercise until 85% of the maximum predicted heart rate was reached. All exercise tolerance tests used a standard Bruce multistage exercise test protocol.|baseline (visit 2) and week 6 (visit 5)|||seconds||Standard Deviation|Mean
686809|NCT01484873|Secondary|Gastric Emptying Rate (13C-octanoic Acid Isotope Excretion Half Life)|Change in the isotope excretion half life during a gastric emptying test at baseline and at 50 weeks|baseline, 50 weeks|||minutes||95% Confidence Interval|Mean
686810|NCT01484873|Secondary|Insulin Secretion (Area Under the Curve)|Change in insulin secretion from baseline|baseline, 50 weeks|||120 min*uU/mL x||95% Confidence Interval|Mean
686811|NCT01484873|Secondary|Visual Analogue Scales for Post-meal Satiety|Change in visual analogue scales scores from baseline to 50 weeks. Higher score indicates greater satiety (minimum 0, maximum 100).|baseline, 50 weeks|||mm||95% Confidence Interval|Mean
686812|NCT01484873|Secondary|Resting Energy Expenditure (Kcals Per Day)|Change in resting energy expenditure from baseline to 50 weeks|baseline, 50 weeks|8 patients completed the study but one patient did not have REE data available due to technical difficulties||kcal/day||95% Confidence Interval|Mean
686813|NCT01484873|Primary|Body Weight (kg)|Change in body weight from baseline to end of study|baseline, 50 weeks|Patients that completed the study||kg||95% Confidence Interval|Mean
686814|NCT01484834|Secondary|Pain Perception|"Pain perception were evaluated by the diagram of pain proposed by Corlett in 1995. The part of body which had pain were indicated by the participant. The data were analysed as yes or no and reported as Odds ratio."|The participants were followed for 3 months|||Odds Ratio||95% Confidence Interval|Number
686815|NCT01484834|Secondary|Changes in Disease Prevalence|the changes in disease prevalence was measured in the same instrument QVS-80. The chronic disease was self-related by the participants.|The participants were followed for 3 months|||participants||95% Confidence Interval|Number
686816|NCT01484834|Secondary|Occupational Environment|The occupational environment was assessed by the quality of life questionnaire. (QVS-80). It considers physical aspects like accessibility and psycologic aspects such as stress. The domain consists of 11 questions about occupational environment. The syntax of QVS-80 put the results in a scale of 0 -100 points (the higher the better).|The participants were followed for 3 months|||units on a scale 0-100||Standard Deviation|Median
686817|NCT01484834|Secondary|Physical Activity Level|The level of physical activity was evaluated by the questionnaire of quality of life. (QVS-80). The physical activity domain is composed of 15 questions considering the ammount of physical activity practiced during leisure time. The instrument is structured in 5 points Lickert Scale. The syntax of QVS-80 put the results in a scale of 0 -100 points (the higher the better).|The participants were followed for 3 months|||units on a scale||Standard Deviation|Median
686818|NCT01484834|Primary|Quality of Life|The instrument contains 80 questions, of which 67 were structured in 5 points Lickert Scale. QVS-80 has four domains: Health Domain (Health) Physical activity (PA), occupational environment domain (AO) and perception of QoL (QOL). The health domain is composed of 30 questions, and the thirteen initial questions refer to history of the existence of chronic diseases such as hypertension, diabetes, obesity, dyslipidemias, bronchitis, allergic rhinitis and cancer; the remaining questions relate to lifestyle and living habits, such as quality of sleep, smoking and consumption of alcohol. The domain of physical activity consists of 15 questions on physical activity. The Domain workplace consists of 11 questions about the physical activity at work and occupational environment. The Domain perception of QoL consists of 24 questions about personal characteristics, and autonomy. The syntax of QVS-80 put the results in a scale of 0 -100 points (the higher the better).|The participants were followed for 3 months|||units on a scale||Standard Deviation|Median
686883|NCT01484197|Secondary|FEV1 at Each Time-Point on Day 1 and Day 2|Spirometry was conducted according to internationally accepted standards post-dose at 0, 15 and 30 minutes; 1, 2, 3, 4, 8, 12 hours on Day 1 and 23.16 and 23.75 hours on Day 2. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.|Day 1, Day 2|Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement||Liters||Standard Deviation|Mean
686819|NCT01484652|Primary|SPID48 (Summed Pain Intensity Difference)|Pain intensity (PI) is measured using the 11-point (0-10) Numeric Pain Rating Scale (NPRS) score. PID is the arithmetic difference in NPRS score at the time point of interest from the baseline score. SPID48 is the sum of time-weighted PID scores measured 22 times over the 48 hour assessment period, with a total score ranging from -480 (worst) to 480 (best). A higher SPID value indicates greater pain relief.|48 hours|The analysis population for the primary outcome measure was the modified intent-to-treat population (mITT). The mITT analysis population includes 303 subjects from Cohort 2. Missing pain intensity difference scores were imputed using a multiple imputation method.||scores on a scale||Standard Error|Mean
686820|NCT01484561|Secondary|LS Mean Change at End of Period 2 From End of Period 1 HAQ-DI Score|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Day 43 of Period 1, Day 29 of Period 2|FAS||score on a scale||Standard Error|Least Squares Mean
686821|NCT01484561|Secondary|LS Mean Change at End of Period 2 From Baseline HAQ-DI Score|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Day 1 of Period 1, Day 29 of Period 2|FAS||score on a scale||Standard Error|Least Squares Mean
686822|NCT01484561|Secondary|LS Mean Change at End of Period 1 From Baseline Health Assessment Questionnaire Disability Index (HAQ-DI) Score|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Day 1 of Period 1, Day 43 of Period 1|FAS||score on a scale||Standard Error|Least Squares Mean
686823|NCT01484561|Secondary|LS Mean Change at End of Period 2 From End of Period 1 in Patient Assessment of Arthritis Pain|Participant's assessed the severity of their arthritis pain using a 100 mm VAS placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.|Day 43 of Period 2, Day 29 of Period 2|FAS||mm||Standard Error|Least Squares Mean
686824|NCT01484561|Secondary|LS Mean Change at End of Period 2 From Baseline in Patient Assessment of Arthritis Pain|Participant's assessed the severity of their arthritis pain using a 100 mm VAS placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.|Day 1 of Period 1, Day 29 of Period 2|FAS||mm||Standard Error|Least Squares Mean
686825|NCT01484561|Secondary|LS Mean Change at End of Period 1 From Baseline in Patient Assessment of Arthritis Pain|Participant's assessed the severity of their arthritis pain using a 100 mm VAS placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.|Day 1 of Period 1, Day 43 of Period 1|FAS||mm||Standard Error|Least Squares Mean
686826|NCT01484561|Secondary|LS Mean Change at End of Period 2 From End of Period 1 in Physician Global Assessment of Arthritis|A physician assessed how the participant's overall arthritis appeared at the time of the visit. This was an evaluation based on the participant's disease signs, functional capacity and physical examination. The physician’s response was recorded using a 100 mm VAS, where 0 mm = very good and 100 mm = very poor.|Day 43 of Period 1, Day 29 of Period 1|FAS||mm||Standard Error|Least Squares Mean
686827|NCT01484561|Secondary|LS Mean Change at End of Period 2 From Baseline in Physician Global Assessment of Arthritis|A physician assessed how the participant's overall arthritis appeared at the time of the visit. This was an evaluation based on the participant's disease signs, functional capacity and physical examination. The physician’s response was recorded using a 100 mm VAS, where 0 mm = very good and 100 mm = very poor.|Day 1 of Period 1, Day 29 of Period 2|FAS||mm||Standard Error|Least Squares Mean
686828|NCT01484561|Secondary|LS Mean Change at End of Period 1 From Baseline in Physician Global Assessment of Arthritis|A physician assessed how the participant's overall arthritis appeared at the time of the visit. This was an evaluation based on the participant's disease signs, functional capacity and physical examination. The physician’s response was recorded using a 100 mm VAS, where 0 mm = very good and 100 mm = very poor.|Day 1 of Period 1, Day 43 of Period 1|FAS||mm||Standard Error|Least Squares Mean
686829|NCT01484561|Secondary|LS Mean Change at End of Period 2 From End of Period 1 in PGAA|Participants answered the following question, “Considering all the ways your arthritis affects you, how are you feeling today?” The participants responses were recorded using a 100 mm VAS, where 0 mm = very well and 100 mm = very poorly.|Day 43 of Period 1, Day 29 of Period 2|FAS||mm||Standard Error|Least Squares Mean
686830|NCT01484561|Secondary|LS Mean Change at End of Period 2 From Baseline in PGAA|Participants answered the following question, “Considering all the ways your arthritis affects you, how are you feeling today?” The participants responses were recorded using a 100 mm VAS, where 0 mm = very well and 100 mm = very poorly.|Day 1 of Period 1, Day 29 of Period 2|FAS||mm||Standard Error|Least Squares Mean
686831|NCT01484561|Secondary|LS Mean Change at End of Period 1 From Baseline in Patient Global Assessment of Arthritis (PGAA)|Participants answered the following question, “Considering all the ways your arthritis affects you, how are you feeling today?” Participants responded by using a 0 - 100 millimeter (mm) visual analog scale (VAS), where 0 mm = very well and 100 mm = very poorly.|Day 1 of Period 1, Day 43 of Period 1|FAS||mm||Standard Error|Least Squares Mean
686832|NCT01484561|Secondary|LS Mean Change at End of Period 2 From End of Period 1 in CRP||Day 43 of Period 1, Day 29 of Period 2|FAS||mg/L||Standard Error|Least Squares Mean
686833|NCT01484561|Secondary|LS Mean Change at End of Period 2 From Baseline in CRP||Day 1 of Period 1, Day 29 of Period 2|FAS||mg/L||Standard Error|Least Squares Mean
686834|NCT01484561|Secondary|LS Mean Change at End of Period 1 From Baseline in CRP||Day 1 of Period 1, Day 43 of Period 1|FAS||mg/L||Standard Error|Least Squares Mean
686835|NCT01484561|Secondary|LS Mean Change at End of Period 2 From End of Period 1 in Swollen Joint Count|Swollen joint count included 66 joints. Assessor assessed joints for swelling using the following scale: present/absent/not done/not applicable (to be used for artificial joints). Joints assessed included: upper body (temporomandibular, sternoclavicular, acromioclavicular), upper extremity (shoulder, elbow, wrist, MCP, thumb IP, PIP, and DIP), and lower extremity (knee, ankle, tarsus, MTP, great toe IP, proximal and distal interphalangeals combined [PIP]).|Day 43 of Period 1, Day 29 of Period 2|FAS||swollen joints||Standard Error|Least Squares Mean
686836|NCT01484561|Secondary|LS Mean Change at End of Period 2 From Baseline in Swollen Joint Count|Swollen joint count included 66 joints. Assessor assessed joints for swelling using the following scale: present/absent/not done/not applicable (to be used for artificial joints). Joints assessed included: upper body (temporomandibular, sternoclavicular, acromioclavicular), upper extremity (shoulder, elbow, wrist, MCP, thumb IP, PIP, and DIP), and lower extremity (knee, ankle, tarsus, MTP, great toe IP, proximal and distal interphalangeals combined [PIP]).|Day 1 of Period 1, Day 29 of Period 2|FAS||swollen joints||Standard Error|Least Squares Mean
686837|NCT01484561|Secondary|LS Mean Change at End of Period 1 From Baseline in Swollen Joint Count|Swollen joint count included 66 joints. Assessor assessed joints for swelling using the following scale: present/absent/not done/not applicable (to be used for artificial joints). Joints assessed included: upper body (temporomandibular, sternoclavicular, acromioclavicular), upper extremity (shoulder, elbow, wrist, MCP, thumb IP, PIP, and DIP), and lower extremity (knee, ankle, tarsus, MTP, great toe IP, proximal and distal interphalangeals combined [PIP]).|Day 1 of Period 1, Day 43 of Period 1|FAS||swollen joints||Standard Error|Least Squares Mean
686838|NCT01484561|Secondary|LS Mean Change at End of Period 2 From End of Period 1 in Tender/Painful Joint Count|68 joints were assessed by a joint assessor to determine the number of joints that were considered tender or painful Assessed joints included: upper body (temporomandibular, sternoclavicular, acromioclavicular), upper extremity (shoulder, elbow, wrist, MCP, thumb IP, PIP, and DIP), and lower extremity (hip, knee, ankle, tarsus, MTP, great toe IP, proximal and distal interphalangeals combined [PIP]).|Day 43 of Period 1, Day 29 of Period 2|FAS||tender/painful joints||Standard Error|Least Squares Mean
686839|NCT01484561|Secondary|LS Mean Change at End of Period 2 From Baseline in Tender/Painful Joint Count|68 joints were assessed by a joint assessor to determine the number of joints that were considered tender or painful Assessed joints included: upper body (temporomandibular, sternoclavicular, acromioclavicular), upper extremity (shoulder, elbow, wrist, MCP, thumb IP, PIP, and DIP), and lower extremity (hip, knee, ankle, tarsus, MTP, great toe IP, proximal and distal interphalangeals combined [PIP]).|Day 1 of Period 1, Day 29 of Period 2|FAS||tender/painful joints||Standard Error|Least Squares Mean
686840|NCT01484561|Secondary|LS Mean Change at End of Period 1 From Baseline in Tender/Painful Joint Count|68 joints were assessed by a joint assessor to determine the number of joints that were considered tender or painful Assessed joints included: upper body (temporomandibular, sternoclavicular, acromioclavicular), upper extremity (shoulder, elbow, wrist, MCP, thumb interphalangeal [IP], PIP, and distal interphalangeals [DIP]), and lower extremity (hip, knee, ankle, tarsus, metatarsophalangeals [MTP], great toe IP, proximal and distal interphalangeals combined [PIP]).|Day 1 of Period 1, Day 43 of Period 1|FAS||tender/painful joints||Standard Error|Least Squares Mean
686841|NCT01484561|Secondary|LS Mean Change at End of Period 2 From End of Period 1 DAS28-4 (CRP)|DAS28 calculated from the number of SJC and PJC using the 28 joints count, the ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|Day 43 of Period 1, Day 29 of Period 2|FAS||score on a scale||Standard Error|Least Squares Mean
686842|NCT01484561|Secondary|LS Mean Change at End of Period 2 From Baseline DAS28-4 (CRP)|DAS28 calculated from the number of SJC and PJC using the 28 joints count, the ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|Day 1 of Period 1, Day 29 of Period 2|FAS||score on a scale||Standard Error|Least Squares Mean
686843|NCT01484561|Secondary|LS Mean Change at End of Period 1 From Baseline DAS28-4 (CRP)|DAS28 calculated from the number of SJC and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|Day 1 of Period 1, Day 43 of Period 1|FAS||score on a scale||Standard Error|Least Squares Mean
686844|NCT01484561|Secondary|LS Mean Change at End of Period 2 From End of Period 1 in DAS28-3 (CRP)|DAS28 calculated from the tender/painful joint count, SJC using the 28 joints count, and CRP value. DAS28 ≤3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|Day 43 of Period 1, Day 29 of Period 2|FAS||score on a scale||Standard Error|Least Squares Mean
686845|NCT01484561|Secondary|LS Mean Change at End of Period 2 From Baseline in DAS28-3 (CRP)|DAS28 calculated from the tender/painful joint count, SJC using the 28 joints count, and CRP value. DAS28 ≤3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|Day 1 of Period 1, Day 29 of Period 2|FAS||score on a scale||Standard Error|Least Squares Mean
686846|NCT01484561|Secondary|Least Squares (LS) Mean Change at End of Period 1 From Baseline in Disease Activity Score Based on 28-Joint Count CRP (DAS28-3 [CRP])|DAS28 calculated from the tender/painful joint count, swollen joint count (SJC) using the 28 joints count, and CRP value. DAS28 less than or equal to (≤)3.2 equals (=) low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity.|Day 1 of Period 1, Day 43 of Period 1|FAS||score on a scale||Standard Error|Least Squares Mean
686847|NCT01484561|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response|ACR70 response: ≥70% improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant' assessment of functional disability via a HAQ, and 5) CRP at each visit.|Day 1 of Period 1 to Day 43 of Period 1, Day 1 of Period 1 to Day 29 of Period 2|FAS (NRI, LOCF)||percentage of participants|||Number
686848|NCT01484561|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response|ACR50 response: ≥50% improvement in tender or swollen joint counts and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a HAQ, and 5) CRP at each visit.|Day 1 of Period 1 to Day 43 of Period 1, Day 1 of Period 1 to Day 29 of Period 2|FAS (NRI, LOCF)||percentage of participants|||Number
686849|NCT01484561|Secondary|Percentage of Participants Achieving an American College of Rheumatology 20% (ACR20) Response|ACR20 response: greater than or equal to (≥)20 percent (%) improvement in tender joint count; ≥20% improvement in swollen joint count; and ≥20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Day 1 of Period 1 to Day 43 of Period 1, Day 1 of Period 1 to Day 29 of Period 2|FAS, missing values while participant was still enrolled utilized last observation carried forward (LOCF) imputation while participants with missing values after a participant was discontinued from study participation (for any reason) were considered to be nonresponders (nonresponder imputation [NRI])||percentage of participants|||Number
686850|NCT01484561|Secondary|Adjusted Geometric Mean-Fold Change at End of Period 2 From End of Period 1 in Serum Creatinine|Blood samples were collected from participants at screening, predose on Day 1 of Period 1, on the last day of Period 1 and on the last day of Period 2 for assessment of serum creatinine levels. Serum creatinine values in mg/dL reported by the central laboratory were used.|Day 43 of Period 1, Day 29 of Period 2|FAS OC; three participants were excluded (took wrong treatment) from the FAS analysis of change at end of Period 2 from end of Period 1 in serum creatinine.||fold change||90% Confidence Interval|Geometric Mean
686851|NCT01484561|Secondary|Adjusted Geometric Mean-Fold Change From End of Period 2 From Baseline in Serum Creatinine|Blood samples were collected from participants at screening, predose on Day 1 of Period 1, on the last day of Period 1 and on the last day of Period 2 for assessment of serum creatinine levels. Serum creatinine values in mg/dL reported by the central laboratory were used. Baseline for serum creatinine was defined as the mean of values obtained at screening and predose on Day 1 of Period 1.|Day 1 of Period 1, Day 29 of Period 2|FAS OC; three participants were excluded (took wrong treatment) from the FAS analysis of change at end of Period 2 from baseline in serum creatinine.||fold change||90% Confidence Interval|Geometric Mean
686852|NCT01484561|Secondary|Adjusted Geometric Mean-Fold Change at End of Period 1 From Baseline in Serum Creatinine|Blood samples were collected from participants at screening, predose on Day 1 of Period 1, on the last day of Period 1 and on the last day of Period 2 for assessment of serum creatinine levels. Serum creatinine values in milligrams per deciliter (mg/dL) reported by the central laboratory were used. Baseline for serum creatinine was defined as the mean of values obtained at screening and predose on Day 1 of Period 1.|Day 1 of Period 1, Day 43 of Period 1|FAS OC; one participant was excluded (took wrong treatment) from the FAS analysis of change at end of Period 1 from baseline in serum creatinine.||fold change||90% Confidence Interval|Geometric Mean
686853|NCT01484561|Secondary|Adjusted Geometric Mean-Fold Change at End of Period 2 From End of Period 1 in eGFR Using the Cockcroft-Gault Equation|eGFR was calculated using the Cockcroft-Gault equation normalized to 1.73 m^2 body surface area.|Day 43 of Period 1, Day 29 of Period 2|FAS OC; three participants were excluded (took wrong treatment) from the FAS analysis of change at end of Period 2 from end of Period 1 in eGFR (Cockcroft-Gault).||fold change||90% Confidence Interval|Geometric Mean
686854|NCT01484561|Secondary|Adjusted Geometric Mean-Fold Change at End of Period 2 From Baseline in eGFR Using the Cockcroft-Gault Equation|eGFR was calculated using the Cockcroft-Gault equation normalized to 1.73 m^2 body surface area. Baseline was defined as the mean of the values obtained at Screening and on predose in Period 1/Day 1.|Day 1 of Period 1, Day 29 of Period 2|FAS OC; three participants were excluded (took wrong treatment) from the FAS analysis of change at end of Period 2 from baseline in eGFR (Cockcroft-Gault).||fold change||90% Confidence Interval|Geometric Mean
686855|NCT01484561|Secondary|Adjusted Geometric Mean-Fold Change at End of Period 1 From Baseline in eGFR Using the Cockcroft-Gault Equation|eGFR was calculated using the Cockcroft-Gault equation normalized to 1.73 m^2 body surface area. Baseline was defined as the mean of the values obtained at Screening and on predose in Period 1/Day 1.|Day 1 of Period 1, Day 43 of Period 1|FAS OC; one participant was excluded (took wrong treatment) from the FAS analysis of change at end of Period 1 from baseline in eGFR (Cockcroft-Gault).||fold change||90% Confidence Interval|Geometric Mean
686856|NCT01484561|Secondary|Adjusted Geometric Mean-Fold Change at End of Period 2 From End of Period 1 in eGFR Using MDRD|eGFR was calculated using the MDRD equation with eGFR values normalized to 1.73 m^2 body surface area.|Day 43 of Period 1, Day 29 of Period 2|FAS (OC); three participants were excluded (took wrong treatment) from the FAS analysis of change at end of Period 2 from end of Period 1 in eGFR (MDRD).||fold change||90% Confidence Interval|Geometric Mean
686857|NCT01484561|Secondary|Adjusted Geometric Mean-Fold Change at End of Period 2 From Baseline in eGFR Using MDRD|eGFR was calculated using the MDRD equation with eGFR values normalized to 1.73 m^2 body surface area. Baseline was defined as the mean of the values obtained at Screening and on predose in Period 1/Day 1.|Day 1 of Period 1, Day 29 of Period 2|FAS OC; three participants were excluded (took wrong treatment) from the FAS analysis of change at end of Period 2 from baseline in eGFR (MDRD).||fold change||90% Confidence Interval|Geometric Mean
686858|NCT01484561|Secondary|Adjusted Geometric Mean-Fold Change at End of Period 1 From Baseline in Estimated Glomerular Filtration Rate (eGFR) Using Modified Diet in Renal Disease (MDRD)|eGFR was calculated using the MDRD equation and normalized to 1.73 m^2 body surface area. Baseline was defined as the mean of the values obtained at Screening and on predose in Period 1/Day 1.|Day 1 of Period 1, Day 43 of Period 1|FAS (OC); one participant was excluded (took wrong treatment) from the FAS analysis of change at end of Period 1 from baseline in eGFR (MDRD).||fold change||90% Confidence Interval|Geometric Mean
686859|NCT01484561|Secondary|Adjusted Geometric Mean-Fold Change at End of Period 2 From End of Period 1 in mGFR|mGFR was determined using iohexol serum clearance using compartmental modeling of the iohexol serum concentration-time data. mGFR values were normalized to 1.73 m^2 body surface area.|Day 43 of Period 1, Day 29 of Period 2|FAS OC; three participants were excluded (took wrong treatment) from the FAS analysis of change at end of Period 2 from end of Period 1 in mGFR.||fold change||90% Confidence Interval|Geometric Mean
686860|NCT01484561|Secondary|Adjusted Geometric Mean-Fold Change at the End of Period 2 From Baseline in mGFR|mGFR was determined using iohexol serum clearance using compartmental modeling of the iohexol serum concentration-time data. mGFR values were normalized to 1.73 m^2 body surface area. Baseline was defined as the mean of the values obtained at Run-in and on predose in Period 1/Day 1.|Day 1 of Period 1, Day 29 of Period 2|FAS OC; three participants were excluded (took wrong treatment) from the FAS analysis of change at end of Period 2 from baseline in mGFR.||fold change||90% Confidence Interval|Geometric Mean
686861|NCT01484561|Primary|Adjusted Geometric (Geo) Mean-Fold Change at End of Period 1 From Baseline in Measured Glomerular Filtration Rate (mGFR)|Glomerular filtration rate (GFR) is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. GFR can be measured directly or estimated using established formulas. mGFR was determined using iohexol serum clearance using compartmental modeling of the iohexol serum concentration-time data. mGFR values were normalized to 1.73 meters squared (m^2) body surface area. A normal GFR is greater than (>)90 milliliters per minute (mL/min), although children and older people usually have a lower GFR. Lower values indicate poor kidney function. A GFR <15 mL/min is consistent with kidney failure. Baseline was defined as the mean of the values obtained at Run-in and on predose in Period 1/Day 1.|Day 1 of Period 1, Day 43 of Period 1|Full Analysis Set (FAS): all randomized participants who received at least 1 dose of the test article (CP-690,550 or placebo). Observed Case (OC): missing data were not imputed. One participant was excluded (took wrong treatment) from FAS analysis of change at end of Period 1 from baseline in mGFR.||fold change||90% Confidence Interval|Geometric Mean
686862|NCT01484496|Secondary|Percentage of Par. Whose Average Prednisone Dose Had Been Reduced by >=25% From Baseline to <=7.5 mg/Day During Weeks 40 Through 52 in Par. Receiving Greater Than 7.5 mg/Day at Baseline|For the analysis of steroid use, all steroid dosages were converted to a prednisone equivalent in mg. The average daily prednisone dose was calculated taking into account all steroids taken intravenously, intramuscularly, SC, intradermally and orally for both SLE and non-SLE reasons. A responder was defined as having a prednisone reduction by >=25% from Baseline to <=7.5 mg/day during Weeks 40 through 52. At Baseline, the average daily prednisone dose was the sum of all prednisone doses over 7 consecutive days up to, but not including Day 0, divided by 7. For this analysis, the average prednisone dose was the total prednisone dose during weeks 40 through 52 divided by the number of days during Weeks 40 through 52. Analysis was performed using a logistic regression model with covariates treatment group, Baseline prednisone dose, Baseline SELENA SLEDAI score, (<=9 vs >=10), Baseline complement levels (low C3 and/or C4 vs. no low C3 or C4) and race (black vs. other).|Baseline (Day 0, prior to dosing), Weeks 40 through Week 52|ITT population. Only par. with Baseline prednisone dose >7.5 mg/day were included.||Percentage of par.|||Number
686863|NCT01484496|Secondary|Time to First Severe Flare (as Measured by the Modified SLE Flare Index)|Time to first severe SLE flare is defined as the number of days from treatment start date until the participant met an event (event date – treatment start date +1). Analyses of severe SLE flare was performed on modified SELENA SLEDAI SLE flare index that excludes severe flares that were triggered only by an increase in SELENA SLEDAI score to >12 (since this may only represent a modest increase in disease activity). Only post-baseline severe flares were considered.|Baseline (Day 0, prior to dosing) to Week 52|ITT population. Only those participants available at that particular timepoints were analyzed.||Days||Full Range|Median
686864|NCT01484496|Primary|Percentage of Par. Achieving a SLE Responder Index (SRI) Response Rate at Week 52|SRI response is defined as >=4 point reduction, from Baseline in safety of estrogen in lupus national assessment (SELENA) systemic lupus erythematosus disease activity index (SLEDAI) score, no worsening (increase of <0.30 points from Baseline) in physician's global assessment (PGA) and no new British Isles Lupus Assessment Group of SLE clinics (BILAG) A organ domain score or 2 new BILAG B organ domain scores compared with Baseline. Analysis was performed using a logistic regression model for the comparison between belimumab and placebo with covariates treatment group, Baseline SELENA SLEDAI score (<=9 vs. >=10), Baseline complement levels (low C3 and/or C4 vs. no low C3 or C4) and race (black vs. other).|Week 52|Intention-To-Treat (ITT) Population: comprised of all par. who were randomized and treated with at least one dose of study treatment. Three par. did not have a Baseline PGA assessment; therefore, were not included.||Percentage of par.|||Number
686865|NCT01484314|Secondary|Incidence of Grade 3/4 Thrombocytopenic Events|To assess whether eltrombopag decreases the incidence of grade 3/4 thrombocytopenic events by day 1 of Cycle 3 of chemotherapy|2 years|Terminated with 1 patient enrolled; no data due to patient privacy.|||||
686866|NCT01484314|Primary|Safety and Tolerability|To determine whether eltrombopag administration results in an increased number of participants with adverse events.|2 years|Terminated with 1 patient enrolled; no data due to patient privacy.|||||
686867|NCT01484314|Primary|Maintenance of Platelet Count|To determine the proportion of patients with relapsed multiple myeloma in whom eltrombopag maintains platelet counts at > 90% of baseline platelet counts with no more than 4 units of platelet transfusions at day 1 of Cycle 3 of chemotherapy|2 years|Terminated with 1 patient enrolled; no data due to patient privacy.|||||
686868|NCT01484197|Secondary|Area Under the Curve Pre-dose to 24 Hour Post Dose (AUC0-24h)||Day 1, Day 7|PK Analysis Set||hour*pg/mL||Standard Deviation|Mean
686869|NCT01484197|Secondary|Observed Maximum Concentration (Cmax) After Drug Administration||Day 1, Day 7|PK Analysis Set||pg/mL||Standard Deviation|Mean
686870|NCT01484197|Secondary|Time to Reach Maximum Concentration (Tmax) After Drug Administration||Day1, Day 7|PK Analysis Set||Hours||Full Range|Median
686871|NCT01484197|Secondary|Number of Participants With Adverse Events as a Measure of Safety|Adverse event are defined as any unfavorable and unintended diagnosis, symptoms, sign (including an abnormal lab finding), syndrome or disease which either occurs during the study, having been absent at baseline, or if present at baseline appear to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization , cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgments of the investigators represent significant hazards. Additional information about adverse events can be found in the Adverse Event section|Up to 101 days|Safety population inlcuded all participants who received at least one dose of study drug.||Participants|||Number
686872|NCT01484197|Secondary|Number of Puffs of Rescue Medicine|Salbutamol (100 µg/puff) was used as rescued medicine. The total number of puffs per day was calculated and divided by the number of days with data to determine the mean daily number of puffs of rescue medication for each patient and was recorded in the patient diary from Baseline until Day 8 of Treatment Period 4. Analysis of covariance with treatment, period, sequence, and subject nested within sequence as fixed effect.|Up to 101 days|Participants in the Pharmacodynamics Analysis set (included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement) who used rescue medication.||Puffs/day||90% Confidence Interval|Least Squares Mean
686873|NCT01484197|Secondary|Peak Expiratory Flow Rate in the Morning in the Evening|PEFR was measured on all days from Screening Visit 2 to end of study visit: twice daily pre-dose (prior to Inhaled Corticosteroids) and approximately 12 hours post-dose (during the treatment period). Each subject was provided with a PEFR meter and recorded the PEFR readings in a daily diary. repeated measures. Analysis of covariance with treatment, period, sequence, day and treatment-day interaction as fixed effect and subject as a random effect and baseline PEFR as a covariate in the model.|Up to 101 days|Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement.||Liters per second||Standard Error|Least Squares Mean
686874|NCT01484197|Secondary|Standardized FEV1 AUC Between Baseline (Pre-dose) and 12 Hour Post-dose (AUC0-12h)|Spirometry was conducted according to internationally accepted standards at predose, 5 , 15 and 30 min, 1, 2, 4, 8 and 12 hours post-dose on Day 1 and Day 7. The standardized (with respect to the length of time) area under the curve (AUC) for FEV1 was calculated using trapezoidal rule between 5 min and 12 h post. Analysis of covariance with treatment, period, sequence and subject nested within sequence as fixed effects and FEV1 period baseline as a covariate.|Day 1, Day 7|Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement.||Liters||90% Confidence Interval|Least Squares Mean
686875|NCT01484197|Secondary|Standardized FEV1 AUC Between Baseline (Pre-dose) and 4 Hour Post-dose (AUC0-4h)|Spirometry was conducted according to internationally accepted standards at predose, 5, 15 and 30 minutes, 1, 2 and 4 hours post-dose on Day 1 and Day 7. The standardized (with respect to the length of time) area under the curve (AUC) for FEV1 was calculated using trapezoidal rule between 5 min and 4 h post. Analysis of Covariance with treatment, period, sequence and subject nested within sequence as fixed effects and period FEV1 baseline as a covariate.|Day 1, Day 7|Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement.||Liters||90% Confidence Interval|Least Squares Mean
686876|NCT01484197|Secondary|Forced Expiratory Flow 25- 75% (FEF25-75) on Day 7 and Day 8|Spirometry was conducted according to internationally accepted standards post-dose at 0, 15 and 30 minutes; 1, 2, 3, 4, 8 and 12 hours on Day 7 and 23.16 and 23.75 hours on Day 8. The forced expiratory flow (FEF) 25%-75% measurement describes the amount of air expelled from the lungs during the middle half (25% - 75%) of the forced vital capacity test and is measured using spirometry.|Day 7, Day 8|Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement||Liters/second||Standard Deviation|Mean
686877|NCT01484197|Secondary|Forced Expiratory Flow 25- 75% (FEF25-75) on Day 1 and Day 2|Spirometry was conducted according to internationally accepted standards post-dose at 0, 15 and 30 minutes; 1, 2, 3, 4, 8 and 12 hours on Day 1 and 23.16 and 23.75 hours on Day 2. The forced expiratory flow (FEF) 25%-75% measurement describes the amount of air expelled from the lungs during the middle half (25% - 75%) of the forced vital capacity test and is measured using spirometry.|Day 1, Day 2|Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement||Liters/second||Standard Deviation|Mean
686878|NCT01484197|Secondary|FEV1/FVC at Each Post-dose Time Point on Day 7 and Day 8|Spirometry was conducted according to internationally accepted standards post-dose at 0, 15 and 30 minutes; 1, 2, 3, 4, 8 and 12 hours on Day 1 and 23.16 and 23.75 hours on Day 2 after treatment. FEV1/FVC ratio is the percentage of the total FVC that is expelled from the lungs during the first second of forced exhalation.|Day 7, Day 8|Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement.||Ratio||Standard Deviation|Mean
686879|NCT01484197|Secondary|FEV1/FVC at Each Post-Dose Time Point on Day 1 and Day 2|Spirometry was conducted according to internationally accepted standards post-dose at 0, 15 and 30 minutes; 1, 2, 3, 4, 8 and 12 hours on Day 1 and 23.16 and 23.75 hours on Day 2. FEV1/FVC ratio is the percentage of the total FVC that is expelled from the lungs during the first second of forced exhalation.|Day1, Day 2|Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement||Ratio||Standard Deviation|Mean
686880|NCT01484197|Secondary|Forced Vital Capacity (FVC) at Each Time-Point on Day 7 and Day 8|Spirometry was conducted according to internationally accepted standards post-dose at 0, 15 and 30 minutes; 1, 2, 3, 4, 8 and 12 hours on Day 7 and 23.16 and 23.75 hours on Day 8. FVC is the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible.|Day 7, Day 8|Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement||Liters||Standard Deviation|Mean
686881|NCT01484197|Secondary|Forced Vital Capacity (FVC) at Each Time-Point on Day 1 and Day 2|Spirometry was conducted according to internationally accepted standards post-dose at 0, 15 and 30 minutes; 1, 2, 3, 4, 8 and 12 hours on Day 1 and 23.16 and 23.75 hours on Day 2. FVC is the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible.|Day 1, Day 2|Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement||Liters||Standard Deviation|Mean
686882|NCT01484197|Secondary|FEV1 at Each Time-Point on Day 7 and Day 8|Spirometry was conducted according to internationally accepted standards at 0, 15 and 30 minutes; 1,2,3,4,8,12 hours on Day 7 and 23.16 and 23.75 hours on Day 8. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.|Day 7, Day 8|Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement||Liters||Standard Deviation|Mean
686884|NCT01484197|Secondary|Time to Peak FEV1 at Day 1 and Day 7|Spirometry was performed according to internationally accepted standards. Time to the peak (maximum) FEV1 is recorded. Analysis of Covariance with treatment, period, sequence and subject nested within sequence as fixed effects and period FEV1 baseline as a covariate.|Day 1, Day 7|Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement.||Hours||Full Range|Median
686885|NCT01484197|Secondary|Peak FEV1 at Day 1 and Day 7|Spirometry was performed according to internationally accepted standards at 0, 15 and 30 minutes; 1,2,3,4,8,12 hours on Day 1 and 23.16 and 23.75 hours on Day 2 after 1 day of treatment and on Day 7 and Day 8 following 7 days of treatment. Peak FEV1 was the maximum FEV1 post treatment. Analysis of Covariance with treatment, period, sequence and subject nested within sequence as fixed effects and period FEV1 baseline included as a covariate.|Day 1, Day 7|Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement.||Liters||90% Confidence Interval|Least Squares Mean
686886|NCT01484197|Secondary|Trough Forced Expiratory Volume in One Second (FEV1) After 1 Day of Treatment|Spirometry was performed according to internationally accepted standards at Day 2. Trough FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Trough FEV1 was defined as the average of the FEV1 measurements at 23 hours 10 minutes and 23 hours 45 minutes post dose at Day 2. Analysis of Covariance with treatment, period, sequence and subject nested within sequence as fixed effects and period FEV1 baseline as a covariate.|Day 2|Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement.||Liters||Standard Error|Least Squares Mean
686887|NCT01484197|Primary|Trough Forced Expiratory Volume in One Second (FEV1) After 7 Days of Treatment|Spirometry was performed according to internationally accepted standards at Day 8. Trough FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Trough FEV1 was defined as the average of the FEV1 measurements at 23 hours 10 minutes and 23 hours 45 minutes post dose.at Day 8. Analysis of Covariance with treatment, period, sequence and subject nested within sequence as fixed effects and period FEV1 baseline as a covariate.|Day 8|Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement.||Liters||Standard Error|Least Squares Mean
686888|NCT01484132|Primary|Change in Urinary Bisphenol A Level (BPA) From Baseline to 14 Days After the Second Dental Treatment|BPA was measured, corrected for specific gravity, in ng/mL. We corrected BPA for specific gravity (SG) using the formula: BPA * [(meanSG – 1)/(SG – 1)], where meanSG is the mean of the SG for the samples examined. Urine samples were collected twice pre-treatment and the geometric mean of BPA at each pre-treatment visit was used as the baseline BPA. Change in BPA was computed using BPA at 14 days after the second dental treatment minus BPA at baseline. The second dental treatment was scheduled as per treatment needs and the schedules of the dentist and patient. It was typically 3-4 weeks after the first dental treatment. Analysis of change in BPA was done using the arithmetic mean.|From Baseline to 14 days after the second dental treatment (The second dental treatment was scheduled as per treatment needs and the schedules of the dentist and patient. It was typically 3-4 weeks after the first dental treatment.)|Of 91 subjects who had at least one pre-treatment and at least one post-treatment urine sample, 15 subjects who had BPA at 14 days after the second dental treatment were used.||ng/mL||Standard Deviation|Mean
686889|NCT01484132|Primary|Change in Urinary Bisphenol A Level (BPA) From Baseline to 1 Day After the Second Dental Treatment|BPA was measured, corrected for specific gravity, in ng/mL. We corrected BPA for specific gravity (SG) using the formula: BPA * [(meanSG – 1)/(SG – 1)], where meanSG is the mean of the SG for the samples examined. Urine samples were collected twice pre-treatment and the geometric mean of BPA at each pre-treatment visit was used as the baseline BPA. Change in BPA was computed using BPA at 1 day after the second dental treatment minus BPA at baseline. The second dental treatment was scheduled as per treatment needs and the schedules of the dentist and patient. It was typically 3-4 weeks after the first dental treatment. Analysis of change in BPA was done using the arithmetic mean.|From Baseline to 1 day after the second dental treatment (The second dental treatment was scheduled as per treatment needs and the schedules of the dentist and patient. It was typically 3-4 weeks after the first dental treatment.)|Of 91 subjects who had at least one pre-treatment and at least one post-treatment urine sample, 26 subjects who had BPA at 1 day after the second dental treatment were used.||ng/mL||Standard Deviation|Mean
686890|NCT01484132|Primary|Change in Urinary Bisphenol A Level (BPA) From Baseline to 14 Days After the First Dental Treatment|BPA was measured, corrected for specific gravity, in ng/mL. We corrected BPA for specific gravity (SG) using the formula: BPA * [(meanSG – 1)/(SG – 1)], where meanSG is the mean of the SG for the samples examined. Urine samples were collected twice pre-treatment and the geometric mean of BPA at each pre-treatment visit was used as the baseline BPA. Change in BPA was computed using BPA at 14 days after the first dental treatment minus BPA at baseline. The first dental treatment was scheduled as per treatment needs and the schedules of the dentist and patient. It was typically within a few weeks of baseline. Analysis of change in BPA was done using the arithmetic mean.|From Baseline to 14 days after the first dental treatment (The first dental treatment was scheduled as per treatment needs and the schedules of the dentist and patient. It was typically within a few weeks of baseline.)|Of 91 subjects who had at least one pre-treatment and at least one post-treatment urine sample, 81 subjects who had BPA at 14 days after the first dental treatment were used.||ng/mL||Standard Deviation|Mean
686904|NCT01483963|Secondary|Investigator Assessment of Improvement With Treatment at Day 92|Investigator assessment of degree of improvement in severity of the participant's treated shoulder compared with screening rated as very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse.|Day 92|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (AA4500 groups) or post baseline (shoulder exercises only group)||Participants|||Count of Participants
687028|NCT01482221|Secondary|Percentage of Patients Who Were Remitted (Defined as MADRS Total Score ≤10) at Week 12|The percentage of patients who were Remitted (defined as MADRS total score ≤10) was calculated.|Baseline to Week 12|The mITT analysis set included all randomized patients, who took IP and who have a non-missing baseline MADRS total score and at least 1 post-baseline MADRS total score, classified according to their randomized treatment.||percentage of participants analyzed|||Number
686891|NCT01484132|Primary|Change in Urinary Bisphenol A Level (BPA) From Baseline to 1 Day After the First Dental Treatment|BPA was measured, corrected for specific gravity, in ng/mL. We corrected BPA for specific gravity (SG) using the formula: BPA * [(meanSG – 1)/(SG – 1)], where meanSG is the mean of the SG for the samples examined. Urine samples were collected twice pre-treatment and the geometric mean of BPA at each pre-treatment visit was used as the baseline BPA. Change in BPA was computed using BPA at 1 day after the first dental treatment minus BPA at baseline. The first dental treatment was scheduled as per treatment needs and the schedules of the dentist and patient. It was typically within a few weeks of baseline. Analysis of change in BPA was done using the arithmetic mean.|From Baseline to 1 day after the first dental treatment (The first dental treatment was scheduled as per treatment needs and the schedules of the dentist and patient. It was typically within a few weeks of baseline.)|Of 91 subjects who had at least one pre-treatment and at least one post-treatment urine sample, 89 subjects who had BPA at 1 day after the first dental treatment were used.||ng/mL||Standard Deviation|Mean
686892|NCT01484132|Primary|Change in Urinary Bisphenol A Level (BPA) From Baseline to 6 Months|BPA was measured, corrected for specific gravity, in ng/mL. We corrected BPA for specific gravity (SG) using the formula: BPA * [(meanSG – 1)/(SG – 1)], where meanSG is the mean of the SG for the samples examined. Urine samples were collected twice pre-treatment and the geometric mean of BPA at each pre-treatment visit was used as the baseline BPA. Change in BPA was computed using BPA at follow-up minus BPA at baseline. Analysis of change in BPA was done using the arithmetic mean.|From Baseline to 6 months|Of 91 subjects who had at least one pre-treatment and at least one post-treatment urine sample, 77 subjects who had BPA at 6 months were used.||ng/mL||Standard Deviation|Mean
686893|NCT01484054|Primary|Subject Reported Overall Lens Handling Using the Contact Lens User Evaluation (CLUE) Questionnaire|The overall lens handling was assessed using the CLUE questionnaire after 7-9 days of follow-up. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.|After 7 to 9 days of lens wear|Analysis was conducted on subjects who successfully complete the study without a protocol deviation affecting at least one primary endpoint.||units on a scale||Standard Error|Least Squares Mean
686894|NCT01484054|Primary|Subject Reported Overall Lens Comfort Using the Contact Lens User Evaluation (CLUE) Questionnaire|The overall lens comfort was assessed using the CLUE questionnaire after 7-9 days of follow-up.The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.|After 7 to 9 days of lens wear|Analysis was conducted on subjects who successfully complete the study without a protocol deviation affecting at least one primary endpoint.||units on a scale||Standard Error|Least Squares Mean
686895|NCT01484054|Primary|Subject Reported Overall Quality of Lens Vision Using the Contact Lens User Evaluation (CLUE) Questionnaire|The overall quality of lens vision was assessed using the CLUE questionnaire after 7-9 days of follow-up. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range from 0-120.|After 7 to 9 days of lens wear|Analysis was conducted on subjects who successfully complete the study without a protocol deviation affecting at least one primary endpoint.||units on a scale||Standard Error|Least Squares Mean
686896|NCT01484041|Secondary|Progression-free Survival|Length of time from study entry until progressive disease|24 weeks|Data not collected for this outcome as study terminated by company prior to completing accrual|||||
686897|NCT01484041|Secondary|Pharmacodynamic Effects|Expression of pFGFR, pFRS2, pERK in tumor tissue and VEGF, bFGF, PLGF, sVEGFR1/2 and FGF23 levels in plasma|24 weeks|Data were not collected for this outcome|||||
686898|NCT01484041|Secondary|Number of Participants With Adverse Events|Number of participants experiencing adverse events|24 weeks|||participants|||Number
686899|NCT01484041|Secondary|Recommended Phase 2 Dose|The dose of dovitinib at which 1 or less subjects experience a dose limiting toxicity when administered every day for 5 days followed by 2 days off schedule in combination with an aromatase inhibitor|4 weeks|Subjects on study evaluated for toxicity||mg|||Number
686900|NCT01484041|Primary|Clinical Benefit Rate|Complete response, partial response, or stable disease at 24 weeks from trial entry as per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression|24 weeks|||participants|||Number
686901|NCT01484028|Primary|Corneal Staining of Grade 3 or 4|Corneal staining was graded using a 5-point scale; 0=None(no staining), 1=Trace, 2=Mild, 3=Moderate, and 4=Severe. Only those eyes with corneal staining grade >= 3 were reported.|After 7-9 days of lens wear|Analysis was conducted on all randomized subjects who wore at least one pair of study lenses.||% of Eyes|Participants|95% Confidence Interval|Number
686902|NCT01484028|Primary|Lens Fit Acceptance|The overall lens fit was evaluated by the Investigators for each eye whether it was acceptable (yes/no).|Dispensing|Analysis was conducted on all randomized subjects who wore at least one pair of study lenses.||% of Eyes|Participants|95% Confidence Interval|Number
686903|NCT01484028|Primary|Monocular Visual Acuity|Monocular distance Snellen visual acuity (VA) scores were coverted to the algorithm of the minimal angle of resolution (LogMAR) scale based on the following formula: LogMAR = Log10 (VA/20) - a*VAR, where Log10 = base 10 logarithm, VA = the Snellen denominator score, a = LogMAR stepsize coefficient and VAR = letter gained or missing in addition to the Snellen denominator score.|Dispensing|Analysis was conducted on all randomized subjects who wore at least one pair of study lenses.||LogMAR score|Participants|Standard Deviation|Mean
687044|NCT01482091|Secondary|Admission Rate||This will be assessed at either discharge from the ED or admission to an inpatient unit, an expected average of 6 hours after triage|||participants|||Number
686905|NCT01483963|Secondary|Subject Satisfaction With Treatment at Day 92|Participant assessment of satisfaction with treatment rated as very satisfied, quite satisfied, neither satisfied nor dissatisfied, quite dissatisfied, or very dissatisfied.|Day 92|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (AA4500 groups) or post baseline (shoulder exercises only group)||Participants|||Count of Participants
686906|NCT01483963|Secondary|Change From Baseline to Day 92 in ASES Function Subscale|Function subscale score ranging from 0-50, with 0 being most dysfunctional, derived from participant assessment of ability to do 10 activities with affected shoulder/arm where 0=unable to do to, 1=very difficult to do, 2=somewhat difficult, and 3=not difficult, and calculated as (cumulative total score for the 10 activity items) × (5/3); adapted from ASES Standardized Shoulder Assessment Form, Patient Self-Evaluation|Baseline, Day 92|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (AA4500 groups) or post baseline (shoulder exercises only group)||units on a scale||Standard Deviation|Mean
686907|NCT01483963|Secondary|Change From Baseline to Day 92 in ASES Pain Subscale|"Pain subscale score ranging from 0-50, with 0 being greatest pain, derived from participant assessment of pain in response to How bad is the pain in your affected shoulder today? on an 11-point numerical rating scale (NRS) where 0=no pain at all and 10=pain as bad as it can be and calculated as (10 - NRS score) x 5); adapted from ASES Standardized Shoulder Assessment Form, Patient Self-Evaluation"|Baseline, Day 92|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (AA4500 groups) or post baseline (shoulder exercises only group)||units on a scale||Standard Deviation|Mean
686908|NCT01483963|Secondary|Change From Baseline to Day 92 in American Shoulder and Elbow Surgeons (ASES) Composite Score|Composite score ranging from 0-100, with 0 being worst pain and function loss, derived from the sum of the scores from pain subscale (11-point NRS where 0=no pain at all and 10=pain) and function subscale (activity questionnaire where 0=unable to do to, 1=very difficult to do, 2=somewhat difficult, and 3=not difficult); adapted from ASES Standardized Shoulder Assessment Form, Patient Self-Evaluation|Baseline, Day 92|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (AA4500 groups) or post baseline (shoulder exercises only group)||units on a scale||Standard Deviation|Mean
686909|NCT01483963|Secondary|Change From Baseline to Day 92 in Passive Internal Rotation|PROM measurement using a goniometer to assess internal rotation with the elbow up to 90° abduction in the affected shoulder|Baseline, Day 92|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (AA4500 groups) or post baseline (shoulder exercises only group)||degrees||Standard Deviation|Mean
686910|NCT01483963|Secondary|Change From Baseline to Day 92 in Active Internal Rotation|AROM measurement using a goniometer to assess internal rotation with the elbow up to 90° abduction in the affected shoulder|Baseline, Day 92|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (AA4500 groups) or post baseline (shoulder exercises only group)||degrees||Standard Deviation|Mean
686911|NCT01483963|Secondary|Change From Baseline to Day 92 in Passive External Rotation|PROM measurement using a goniometer to assess external rotation in the affected shoulder|Baseline, Day 92|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (AA4500 groups) or post baseline (shoulder exercises only group)||degrees||Standard Deviation|Mean
686912|NCT01483963|Secondary|Change From Baseline to Day 92 in Active External Rotation|AROM measurement using a goniometer to assess external rotation in the affected shoulder|Baseline, Day 92|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (AA4500 groups) or post baseline (shoulder exercises only group)||degrees||Standard Deviation|Mean
686913|NCT01483963|Secondary|Change From Baseline to Day 92 in Passive Abduction|PROM measurement using a goniometer to assess abduction in the affected shoulder|Baseline, Day 92|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (AA4500 groups) or post baseline (shoulder exercises only group)||degrees||Standard Deviation|Mean
686914|NCT01483963|Secondary|Change From Baseline to Day 92 in Active Abduction|AROM measurement using a goniometer to assess abduction in the affected shoulder|Baseline, Day 92|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (AA4500 groups) or post baseline (shoulder exercises only group)||degrees||Standard Deviation|Mean
686915|NCT01483963|Secondary|Change From Baseline to Day 92 in Passive Forward Flexion|Passive range of motion (PROM) measurement using a goniometer to assess forward flexion in the affected shoulder|Baseline, Day 92|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (AA4500 groups) or post baseline (shoulder exercises only group)||degrees||Standard Deviation|Mean
686916|NCT01483963|Primary|Change From Baseline to Day 92 in Active Forward Flexion|Active range of motion (AROM) measurement using a goniometer to assess forward flexion in the affected shoulder|Baseline, Day 92|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (AA4500 groups) or post baseline (shoulder exercises only group)||degrees||Standard Deviation|Mean
686917|NCT01483937|Secondary|Head Shake Sensory Organization Test (HS_SOT)|"Head Shake Sensory Organization Test (HS-SOT)
HS-SOT instructs the patient to static stand shoulder width apart with eyes closed and uses the SOT Condition 5 sway surface protocol while shaking the head horizontally 120 degrees per second. This protocol is safe for patients when they have normalized all SOT scores. Because study subjects were reaching SOT normalization after Post Test 2, the data collected was scant and not suitable for analysis."|Pre Test, Post Test 1 and Post Test 4||||||
686918|NCT01483937|Secondary|Self-rated Disability Measured by Vestibular Rehabilitation Benefit Questionnaire Pre Test to Post Test 4|Vestibular Rehabilitation Benefit Questionnaire asks the patient to self-rate disability as it affects their quality of life. Scale goes from zero, no disability, to 100 or maximal disability. The Total Benefit includes two subsets: 1) dizziness symptoms, and 2) quality of life.|Pre test to Post Test 4 or 12 Physical Therapy sessions within 42 days|||units on a scale||Standard Deviation|Mean
686919|NCT01483937|Secondary|Percent of Subjects Decreasing Fall Risk Measured by Berg Balance Scale Pre Test to Post Test 2|"Berg Balance Scale Description: 14-item scale designed to measure balance of the older adult in a clinical setting, and measures mobility related to activities of daily living. Description: This 14-item performance-based instrument is intended for individuals with some degree of balance impairment.
Scoring: A five-point ordinal scale, ranging from 0-4. “0” indicates the lowest level of function and “4” the highest level of function. Total Score = 56 with higher score indicting safer ambulation with lower risk of falling.
Criterion Validity: “Authors support a cut off score of 45/56 for independent safe ambulation”.
Interpretation: 41-56 = low fall risk 21-40 = medium fall risk 0 –20 = high fall risk
Riddle and Stratford, 1999, examined 45/56 cutoff validity and concluded:
Sensitivity = 64% (Correctly predicts fallers)
Specificity = 90% (Correctly predicts non-fallers)"|Pre Test, Post Test 2 after 4 physical therapy sessions within 10 days.|||percentage of participants|||Number
686920|NCT01483937|Secondary|Percent of Subjects Reporting Decrease in Self-report Fall(s) Occurrence Pre Test to Post Test 1|A fall is an unintentional change in position causing an individual to land at a lower level, on an object, the floor, the ground or other surface with or without injury. This includes: slips, trips, falling into other people, being lowered, loss of balance, and legs giving way. (Exclude sudden onset of paralysis, epileptic seizure, or overwhelming external force.)|Pre Test to Post Test 1 after 2 physical therapy sessions within 4 days|||percentage of participants|||Number
686921|NCT01483937|Secondary|Percent of Subjects Decreasing Fall Risk Measured by Functional Gait Assessment Pre Test to Post Test 2|"Functional Gait Assessment is a 10-item gait assessment based on the Dynamic Gait Index. Requirements: A marked 20 foot walkway that is marked with a 12 inch width. Scoring: a four-point ordinal scale, ranging from 0-3 where 0 indicates the lowest level of function and 3 the highest level of function. Total Score = 30 with higher score indicating safer ambulation with lower risk of falling.
Criterion Validity: “Authors support a cut off score of 23/30 for independent safe ambulation”.
Interpretation: 1) 0-19 is predictive of falls in the elderly. 2) 20-22 indicates likelihood of unexplained fall in community-dwelling, older adults, and predictive of likelihood of falling in patients with vestibular disorders.
3) 23-30 = safe ambulators"|Pre Test to Post Test 2 after four physical therapy sessions within 10 days|||percentage of participants|||Number
686922|NCT01483937|Primary|Assessment of the Efficacy of the SEMD Device in Improving Vestibular Function Was Evaluated With Change From Post Test 3 to Post Test 4 Sensory Organization Test (SOT).|Sensory Organization Test (SOT) is a standing balance test that measures the subject's ability to control postural sway under vestibular, visual, and somatosensory conflict. Score ranges from 0 to 100 with higher score indicating better control of postural sway.|Post Test 3 to Post Test 4 after twelve physical therapy sessions (6 weeks)|||units on a scale||Standard Deviation|Mean
686923|NCT01483937|Primary|Assessment of the Efficacy of the SEMD Device in Improving Vestibular Function Was Evaluated With Change in Post Test 2 to Post Test 3 Sensory Organization Test (SOT).|Sensory Organization Test (SOT) is a standing balance test that measures the subject's ability to control postural sway under vestibular, visual, and somatosensory conflict. Score ranges from 0 to 100 with higher score indicating better control of postural sway.|Post Test 2 to Post Test 3 after eight physical therapy sessions (4 weeks)|||units on a scale||Standard Deviation|Mean
686924|NCT01483937|Primary|Assessment of the Efficacy of the SEMD Device in Improving Vestibular Function Was Evaluated With Change in Post Test 1 to Post Test 2 Sensory Organization Test (SOT).|Sensory Organization Test (SOT) is a standing balance test that measures the subject's ability to control postural sway under vestibular, visual, and somatosensory conflict. Score ranges from 0 to 100 with higher score indicating better control of postural sway.|Post Test 1 to Post Test 2 after four physical therapy sessions (two weeks)|||units on a scale||Standard Deviation|Mean
686925|NCT01483937|Primary|Assessment of the Efficacy of the SEMD Device in Improving Vestibular Function Was Evaluated With Change in Pre Test to Post Test 1 Sensory Organization Test (SOT).|Sensory Organization Test (SOT) is a standing balance test that measures the subject's ability to control postural sway under vestibular, visual, and somatosensory conflict. Score ranges from 0 to 100 with higher score indicating better control of postural sway.|Pre Test to Post Test 1 after two physical therapy sessions (one week)|||units on a scale||Standard Deviation|Mean
686926|NCT01483924|Secondary|Efficacy of Apo805K1 as Assessed by Change From Baseline to Week 12 in Physician Global Assessment (PGA) Score|In the PGA, the physician assigns a single estimate of a patient’s overall severity of the disease using a scale ranging from 0 (Clear) to 7 (Severe). (Unlike the LS-PGA, the individual elements of psoriasis plaque morphology or degree of body surface area involvement are not quantified.) Thus, a decrease in PGA score indicates improvement. This outcome measure compared the difference in change in PGA score from baseline to Week 12 between the active treatment groups and the placebo group.|Baseline to 12 weeks|The Efficacy Population was defined as all patients who received at least 1 dose of study medication and completed at least 1 post-baseline efficacy assessment.||units on a scale||Standard Deviation|Mean
686927|NCT01483924|Secondary|Efficacy of Apo805K1 as Assessed by Change From Baseline at Week 12 in Lattice System–Physician Global Assessment (LS-PGA) Scores|The LS-PGA is a standardized method for determining categories of psoriasis severity. The percentage of body surface area involved is assessed on a scale ranging from 1 (0%) to 7 (51–100%); measures of plaque severity (thickness, erythema, and scaling) are assessed using a 4-point scale ranging from “none” to “marked”; and an algorithm is used to combine the above scores to determine a final score on a scale ranging from 0 (clear) to 7 (very severe). Thus, a decrease in LS-PGA score indicates improvement. This outcome measure compared the difference in change in LS-PGA score from baseline to Week 12 between the active treatment groups and the placebo group.|Baseline to 12 weeks|The Efficacy Population was defined as all patients who received at least 1 dose of study medication and completed at least 1 post-baseline efficacy assessment.||units on a scale||Standard Deviation|Mean
687045|NCT01482091|Secondary|Presence of Headache||Participants will be followed for the duration of their ED visit, an expected average of 6 hours|||participants|||Number
686929|NCT01483924|Secondary|Efficacy of Apo805K1 as Assessed by Change From Baseline in Psoriasis Area Severity Index (PASI) Scores|PASI is a quantitative measure of psoriasis that combines an assessment of the severity of lesions and a measurement of how much of the body surface area is affected into a single score ranging from 0 (no disease) to 72 (maximal disease). Thus, a decrease in PASI score indicates improvement. This outcome measure compared the difference in change in PASI score from baseline to Week 12 between the active treatment groups and the placebo group.|Baseline to 12 Weeks|The Efficacy Population was defined as all patients who received at least 1 dose of study medication and completed at least 1 post-baseline efficacy assessment.||units on a scale||Standard Deviation|Mean
686930|NCT01483924|Secondary|T 1/2 of Apo805K1 Following Multiple Doses, Assessed at Day 14|T 1/2 for dosages of 10 mg, 30 mg, 60 mg, or 100 mg Apo805K1, determined on Day 14. Serial blood samples for PK analysis were collected pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose.|12 hours|The Pharmacokinetics Population consisted of all patients who received Apo805K1 and provided evaluable PK data on at least one visit (Day 1 or Day 14)||hour||Standard Deviation|Mean
686931|NCT01483924|Secondary|AUC 0-infinity of Apo805K1 Following Multiple Doses, Assessed at Day 14|AUC 0-infinity for dosages of 10 mg, 30 mg, 60 mg, or 100 mg Apo805K1, determined on Day 14. Serial blood samples for PK analysis were collected pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose.|12 hours|The Pharmacokinetics Population consisted of all patients who received Apo805K1 and provided evaluable PK data on at least one visit (Day 1 or Day 14)||ng *hr/mL||Standard Deviation|Mean
686932|NCT01483924|Secondary|Tmax of Apo805K1 Following Multiple Doses, Assessed at Day 14|Tmax for dosages of 10 mg, 30 mg, 60 mg, or 100 mg Apo805K1, determined on Day 14. Serial blood samples for PK analysis were collected pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose.|12 hours|||hour||Full Range|Median
686933|NCT01483924|Secondary|Cmax of Apo805K1 Following Multiple Doses, Assessed at Day 14|Cmax for dosages of 10 mg, 30 mg, 60 mg, or 100 mg Apo805K1, determined on Day 14. Serial blood samples for PK analysis were collected pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose.|12 hours|The Pharmacokinetics Population consisted of all patients who received Apo805K1 and provided evaluable PK data on at least one visit (Day 1 or Day 14)||ng/mL||Standard Deviation|Mean
686934|NCT01483924|Primary|Number of Patients With Adverse Events|The number of patients in each treatment group who reported at least 1 adverse event, including clinically significant changes from baseline in vital signs, 12-lead ECG, physical examinations and laboratory tests, from the time of the first dose until the last study visit.|12 Weeks|The Safety Population consisted of all patients who received at least 1 dose of study medication.||participants|||Number
686935|NCT01483820|Secondary|To Evaluate the Drug Levels and Pharmacokinetics (PK) of TPI 287 From Blood Samples at Multiple Time Points Within the First 24 Hours on Study.|To evaluate the pharmacokinetics (PK) of TPI 287 in the Phase I population of this trial.|1 year|PK's not run due to early closure of study. Data not collected or analyzed threfore no data exists.|||||
686936|NCT01483820|Secondary|Quality of Life of Children Receiving TPI287 Using PedsQL Questionnaires|To evaluate the impact of QOL of children receiving TPI287 using PedsQL questionnaires|3 years|QOL's not collected due to early closure of study. Data not collected or analyzed threfore no data exists.|||||
686937|NCT01483820|Secondary|Median Overall Survival (OS) of Participants|Overall Survival (OS) and clinical benefit (ORR + stable disease, SD)|3 years|Not evaluated due to early closure. Study data does not exist.|||||
686938|NCT01483820|Secondary|Number of Days Participants Experienced Progression Free Survival (PFS)|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|3 years|||Days|||Number
686939|NCT01483820|Secondary|Number of Participants With Overall Response Assessed Using RECIST Criteria|Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|6 months|||participants|||Number
686940|NCT01483820|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Phase I portion of trial- To determine the safety and tolerability of TPI 287 as a single agent in pediatric and young adult patients with refractory or recurrent neuroblastoma or medulloblastoma. Adverse events collected from time of first dose to 30 days past last dose and until all related events resolved, average of one year.|length of study +30 days|||participants|||Number
686941|NCT01483651|Primary|Area Under the Curve for Glucose Above Baseline|The change in the rate of glucose appearance will be assessed by measuring the stable glucose isotope (dideuterated glucose, D2) using a gas chromatography-mass spectrometry assay. The units of the area under the curve are defined as milligrams per kilogram of glucose, since the dependent variable is a rate of glucose production [mg/kg/min] measured over time [min]. The time variable therefore cancels out. Additionally, this area under the curve is being normalized per microgram of glucagon delivered.|60 minutes after each glucagon administration|||mg/kg glucose per mcg glucagon||Standard Deviation|Mean
686942|NCT01483625|Secondary|Weekly Rescue Medication Use Over the 12 Weeks of Study|Daily rescue albuterol use was recorded in the diary in response to the following question: How many puffs of rescue medication did you use during the last 24 hours? The weekly rescue medication use was derived by summing the daily uses over the 12 weeks and dividing this total by 12 weeks.|12 weeks|TS with non missing rescue medication use.||puffs||Standard Deviation|Mean
686943|NCT01483625|Secondary|Responder Status at Week 12 Clinic Visit|"Responder status was determined at each clinic visit. The number and percentage of subjects in each of the following 3 classes were presented:
Subject recovered without change of therapy (subjects who received an additional course of antibiotics and/or systemic corticosteroids starting after Visit 1 were not included).
Subject recovered but had a change in therapy (subject received an additional course of antibiotics and/or systemic corticosteroids starting after Visit 1).
Subject did not recover."|12 weeks|TS with non missing responder data at week 12. Responder defined by >= 20% improvement. .||participants|||Number
687046|NCT01482091|Secondary|Presence of Bradycardia|Number of participants who had bradycardia|Every 5 minutes until 30 minutes after study drug administration|||participants|||Number
686944|NCT01483625|Secondary|Responder Status at Week 4 Clinic Visit|"Responder status was determined at each clinic visit. The number and percentage of subjects in each of the following 3 classes were presented:
Subject recovered without change of therapy (subjects who received an additional course of antibiotics and/or systemic corticosteroids starting after Visit 1 were not included).
Subject recovered but had a change in therapy (subject received an additional course of antibiotics and/or systemic corticosteroids starting after Visit 1).
Subject did not recover."|4 weeks|Responder defined by >= 20% improvement. TS with non missing responder data.||participants|||Number
686945|NCT01483625|Secondary|Trough FVC (in Litres) at 12 Weeks|The trough Forced Vital Capacity (FVC) was defined as the FVC measurement prior to the next dosing of study drug and approximately 24 hours after the last inhalation of study drug.|12 weeks|TS with non missing FVC data.||Litres||Standard Deviation|Least Squares Mean
686946|NCT01483625|Secondary|Time to Recovery From Acute Respiratory Symptoms|"Time to recovery was assessed with the EXACT-PRO questionnaire tool. The EXACT-PRO was designed to collect data to quantify frequency, severity, and duration of exacerbations in patients with COPD including the onset of and the recovery from COPD exacerbations.
The EXACT-PRO is a 14-item questionnaire. Each attribute or item was assessed on a five- or six-point ordinal scale and summed to yield a total score that was converted to a 0-100 scale, with higher scores indicating a more severe health state or exacerbation.
The EXACT-PRO was answered by the patients on a daily basis in the evening."|12 weeks|TS with non missing EXACT-PRO data.||units on a scale||Standard Deviation|Geometric Mean
686947|NCT01483625|Primary|Trough FEV1 After 12 Weeks on Study Drug|The primary endpoint was trough forced expiratory volume in 1 second (FEV1) after 12 weeks on study drug. Trough forced expiratory volume in 1 second (FEV1)was defined as the FEV1 measurement prior to the next dosing of study drug and approximately 24 hours after the last inhalation of study drug.|12 weeks|Treated Set (TS) with non missing FEV1 data.||Litre||Standard Error|Least Squares Mean
686948|NCT01483599|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16|The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.|Baseline and Week 16|Population analyzed included all participants who were randomized. Here, 'Number of participants analyzed' signifies those participants who were evaluable for this outcome measure.||units on a scale||Standard Deviation|Mean
686949|NCT01483599|Secondary|Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 40|PGA of psoriasis is used to determine the participant’s psoriasis lesions overall at a given time point. Lesions were graded as erythema [0 (no evidence of plaque) to 5 (dusky to deep red coloration)], induration [0 (no plaque evaluation) to 5 (marked plaque evaluation)] and scaling [0 (no evidence of scaling) to 5 (severe; very thick tenacious scaling)]. The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0= cleared; 1= minimal; 2= mild; 3= moderate; 4= marked and 5= severe).|Week 40|Population analyzed included all participants who were randomized. Here, 'Number of participants analyzed' signifies those participants who were evaluable for this outcome measure. The placebo reporting group was not planned to be analyzed in this outcome measure.||percentage of participants|||Number
686950|NCT01483599|Secondary|Difference in Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) in CNTO1959 Groups Compared With Adalimumab Group at Week 16|PGA of psoriasis is used to determine the participant’s psoriasis lesions overall at a given time point. Lesions were graded as erythema [0 (no evidence of plaque) to 5 (dusky to deep red coloration)], induration [0 (no plaque evaluation) to 5 (marked plaque evaluation)] and scaling [0 (no evidence of scaling) to 5 (severe; very thick tenacious scaling)]. The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0= cleared; 1= minimal; 2= mild; 3= moderate; 4= marked and 5= severe).|Week 16|Population analyzed included all participants who were randomized.||percentage of participants|||Number
686951|NCT01483599|Secondary|Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 16|The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percentage (%)-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. PASI 75 response was defined as at least a 75% reduction in PASI relative to Baseline.|Week 16|Population analyzed included all participants who were randomized.||percentage of participants|||Number
686952|NCT01483599|Primary|Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 16|PGA of psoriasis is used to determine the participant’s psoriasis lesions overall at a given time point. Lesions were graded as erythema [0 (no evidence of plaque) to 5 (dusky to deep red coloration)], induration [0 (no plaque evaluation) to 5 (marked plaque evaluation)] and scaling [0 (no evidence of scaling) to 5 (severe; very thick tenacious scaling)]. The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0= cleared; 1= minimal; 2= mild; 3= moderate; 4= marked and 5= severe).|Week 16|Population analyzed included all participants who were randomized.||percentage of participants|||Number
686953|NCT01483378|Primary|Answers to Survey Questions|All enrolled patients completed a survey of baseline characteristics, eligibility for the herpes zoster vaccine, and attitudes regarding herpes zoster vaccination. The survey results from patients who agreed to receive the herpes zoster vaccine were compared to the results of patients who declined to be vaccinated.|January 9, 2012 to February 12, 2012|||Percentage of responders||95% Confidence Interval|Number
687060|NCT01481740|Secondary|Neonatal Acidosis||intraoperative|||pH value||Standard Deviation|Mean
687061|NCT01481740|Secondary|Incidence of Hypotension||intraoperative - postdelivery|||participants|||Number
686954|NCT01483352|Secondary|Design Validation Participant Questionnaire - Percentage of Participants With a Positive Response|The participant questionnaire consisted of two parts including description of routine operations, followed by 23 questions used to determine the following: percentage of participants needing consultation of instructions for use of fixation disc or infusion set; percentage of participants with pain after implantation, percentage of participants with moderate pain during 4 to 6 days after implantation, moderate pain for 7 days or more; percentage of participants with temporal disconnection from infusion set; percentage of participants with use of handling aid for temporal storage; percentage of participants with a reason for temporal disconnection of infusion set from port either sex, shower, or sport; percentage of participants changing fixation disc ≥3 days or infusion set ≥4 days and the cartridge, and percentage of participants cleaning the skin around the port daily, every second day, or every third to fifth day, either with saline during healing or with alcohol after healing.|Week 12|All participants were included in the analysis.||percentage of participants|||Number
686955|NCT01483352|Secondary|Percentage of Participants Achieving Target Glucose Levels|Target glucose values were 70-180 mg/dL. Participants with glucose levels below 70 mg/dL were considered to be under target and those above 180 mg/dL were considered over target. The mean of Glucose-Measurements at the visit date was calculated as follows: a variable was created for each category (“within target [70-180 mg]”, “below target” and “above target”) that tells if the value lies within this category. Then the percentage per participant and visit was calculated. The mean represents the mean of these percentages per participant at the visit.|Screening, Week 12 and 6 Months|All participants were included in the study; n= number of participants analyzed for the given parameter at the specified timepoint||percentage of participants||Standard Deviation|Mean
686956|NCT01483352|Secondary|Glycemic Variability: Percent Coefficient of Variation in Blood Glucose|Both self monitored (SMBG) and continuous (CGM) glucose measurements were used to determine the coefficient of variation in blood glucose. CGM data are only evaluated for a 1 week time period and are no direct comparison to the SMBG that reflect the full time frame between visits.|Screening, Week 12 and Months 6, 9 and 12|All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint||percent of mean glucose value||Standard Deviation|Mean
686957|NCT01483352|Secondary|Continuous Glucose Measurement (CGM) - Glucose Levels|CGM measurements were performed using a diurnal CGM sensor and group means were calculated over 10 minute periods of the CGM measurements.|Screening, Week 12 and 6 Months|All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint||mg/dL||Standard Deviation|Mean
686958|NCT01483352|Secondary|Self Monitored Blood Glucose Levels|Participants monitored glucose levels on a daily basis and recorded for evaluation. Glucose levels are measured as milligrams per deciliter (mg/dL)|Screening, Week 12 and Months 6, 9 and 12|All participants were included in analysis; n= number of participants analyzed for the given parameter at the specified time point||mg/dL||Standard Deviation|Mean
686959|NCT01483352|Secondary|Hemoglobin A1c Levels|Glycated hemoglobin (HbA1c) is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. HbA1c levels are a measure of glycemic control.|Screening, Week 12 and Months 6, 9 and 12|All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint||percent of glycated hemoglobin||Standard Deviation|Mean
686960|NCT01483352|Secondary|Insulin Doses Dispensed From Insulin Pump|Total insulin dose (in international units per milliliter [IU/mL]) from pump was measured per day as mean per day measured over 7 days.|Screening, Week 12 and Months 6, 9 and 12|All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint||IU/mL||Standard Deviation|Mean
686961|NCT01483352|Primary|Percentage of Participants Categorized by Ability of the Port to Deliver Insulin Intraperitonally|Problems in ability to deliver insulin intraperitoneally was determined by the physician and categorized as follows: 1= No problems; 2= Minor problems; 3= Some problems; 4= Major problems and/or replacement of catheter necessary; 5= Severe problems and/or explanation of port necessary. The percentage of participants in each category for the specified time point is presented.|Weeks 2 and 12 and Months 6, 9, 12 and 15|All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint||percentage of participants|||Number
686962|NCT01483352|Primary|Percentage of Participants With Signs of Infection/Allergic Reaction at the Site of Implant|Signs of infection/allergic reaction at the site of implant was determined by the physician and categorized as follows: 1= No problems; 2= Minor problems; 3= Some problems; 4= Major problems and/or replacement of catheter necessary; 5= Severe problems and/or explanation of port necessary. The percentage of participants in each category for the specified time point is presented.|Weeks 2 and 12 and Months 6, 9, 12 and 15|All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint||percentage of participants|||Number
686963|NCT01483352|Primary|Percentage of Participants With Persistent Dull Pain Due to Catheter|Pain due to catheter was determined by a participant questionnaire and categorized as follows: Category 1= No pain; 2= Minor, negligible; 3= Some, noticeable; 4= Major, cumbersome; 5= Severe, almost unbearable. The percentage of participants in each category for the specified time point is presented.|Weeks 2 and 12 and Months 6, 9, 12 and 15|All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint||percentage of participants|||Number
686964|NCT01483352|Primary|Percentage of Participants With Signs of Pain in the Tissue Around the Port|Signs of pain was determined from the participant questionnaire which was categorized as follows: category 1= No pain; 2= Minor, negligible; 3= Some, noticeable; 4= Major, cumbersome; 5=Severe, almost unbearable. The percentage of participants in each category for the specified time point is presented.|Weeks 2 and 12 and Months 6, 9, 12 and 15|All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint||percentage of participants|||Number
686965|NCT01483352|Primary|Percentage of Participants With Signs of Infection in the Tissue Around the Port|Signs of infection were determined by the physician and categorized as follows : Category 1= None; 2= Minor, negligible; 3= Some, noticeable 4= Major; 5= Severe. The percentage of participants in each category for the specified time point is presented.|Weeks 2 and 12 and Months 6, 9, 12 and 15|All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint||percentage of participants|||Number
686966|NCT01483352|Primary|Percentage of Participants With Signs of Redness/Swelling in the Tissue Around the Port|Signs of Redness/Swelling was determined by the physician and was categorized as follows: Category 1= None; 2= Minor, negligible; 3= Some, noticeable; 4= Major; 5= Severe. The percentage of participants in each category for the specified time point is presented.|Weeks 2 and 12 and Months 6, 9, 12 and 15|All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint||percentage of participants|||Number
686967|NCT01483352|Primary|Percentage of Participants With Dislocation of Port|Position of the port was determined by the physician and was categorized as follows: Category 1= No dislocation; 2= Minimal dislocation; 3= Clearly visible dislocation, with minimal impairment of function; 4= Dislocation impairs functions; 5= Dislocation results in disabling functions. The percentage of participants in each category for the specified time point is presented.|Weeks 2 and 12 and Months 6, 9, 12 and 15|All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint||percentage of participants|||Number
686968|NCT01483352|Primary|Percentage of Participants With Problems Involving the Tight Connection Between Port and Skin|Mechanical stability of the device was determined by the stability of the ingrowth surrounding the port as determined by the physician. The ingrowth problems are categorized as follows: Category 1= complete stable Ingrowth, 2= Ingrowth working with negligible problems, 3= Ingrowth working with some problems, 4= Ingrowth working with major problems and 5= Ingrowth resulting in almost non-functional port. The percentage of participants in each category for the specified time point is presented.|Weeks 2 and 12 and Months 6, 9, 12 and 15|All participants were included in the study; number (n)= number of participants analyzed for the given parameter at the specified timepoint||percentage of partcipants|||Number
686969|NCT01483352|Primary|Suitability of the Device - Overall Suitability Score|Suitability of the device was assessed by the investigator using a questionnaire that determined the following: 1) condition of the tissue around the port: tight connection between port and skin (mechanical stability, dislocation of port, signs of redness/swelling, infection, or pain), 2) peritoneal reactions (persistent dull pain due to catheter, signs of infection/allergic reaction) and ability to deliver insulin intraperitonally at every visit after implantation. Suitability score was determined using participant's responses to a questionnaire where 1 equals (=) no problem, 2=minor/negligible problems, 3=some/noticeable problems, 4=major/cumbersome and 5=severe/almost unbearable problems. Each question was scored and an average across the questions was determined as an overall score. The scores ranged from 1 (not at all suitable) to 5 (completely suitable).|Week 12|All participants who received the implant were included in the analysis.||units on a scale||Standard Deviation|Mean
686970|NCT01483209|Secondary|Digital Amputations|The number of digits amputated in our patient cohort is a secondary endpoint of this study. We will use a paired t-test to compare the number of digital amputations in the control versus experimental group.|12 months|Due to insufficient accrual, data analysis was not performed.|||||
686971|NCT01483209|Primary|Perfusion (as Determined by Laser Doppler Measurements)|A paired T-test will be used to compare pre- and post-injection Laser Doppler measurements for the experimental hand. We will again use a paired t-test to compare the experimental hand against the contralateral control hand. Results for the experimental and control groups will be plotted and displayed graphically as percent change in Doppler flow (y-axis) and time (x-axis).|12 months|Due to insufficient accrual, data analysis was not performed.|||||
686972|NCT01483183|Secondary|Part 2: Duration of NSR|The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document.|168 hours||||||
686973|NCT01483183|Secondary|Part 2: Duration of NSR|The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document.|24 hours||||||
686974|NCT01483183|Secondary|Part 2: Time to NSR|The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document.|24 hours||||||
686975|NCT01483183|Secondary|Part 1: Percentage of Participants With NSR|Percent of participants with NSR, defined as NSR for at least 1 minute within 30 minutes of the end of OPC-108459 infusion.|30 minutes|Safety dataset included all participants who had received at least one dose of the trial medication.||percentage of participants|||Number
686976|NCT01483183|Primary|Part 2: Percentage of Subjects With Normal Sinus Rhythm (NSR)|The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document.|24 hours||||||
686977|NCT01483183|Primary|Part 2: Diastolic and Systolic Blood Pressure|The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document.|24 hours||||||
686978|NCT01483183|Primary|Part 2: Ventricular Rate|The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document.|24 hours||||||
686979|NCT01483183|Primary|Part 2: QTcF|The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document.|24 hours||||||
686980|NCT01483183|Primary|Part 2/2 Infusions: AUCt|The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document.|24 hours||||||
686981|NCT01483183|Primary|Part 2/1 Infusion: AUCt|The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document.|24 hours||||||
686982|NCT01483183|Primary|Part 2/2 Infusions: Cmax|The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document.|24 hours||||||
686983|NCT01483183|Primary|Part 2/1 Infusion: Cmax|The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document.|24 hours||||||
686984|NCT01483183|Primary|Part 1: Maximal Change From Baseline in Blood Pressure Within 24 Hour Infusion|Maximum change from baseline in diastolic and systolic blood pressure(BP) collected during vital sign measurements in the 24-hour postdose interval. Participants must be hemodynamically stable defined as a screening systolic blood pressure between 90 to 160 mmHg, diastolic <100 mmHg. BP was measured after at least 3 minutes in the supine position. BP was measured at predose (within 45 minutes of dosing); 3 and 7 minutes and approximately 1, 4, 8, 12, and 24 hours.|24 hours|Safety dataset included all participants who had received at least one dose of the trial medication.||mmHg||Standard Deviation|Mean
686985|NCT01483183|Primary|Part 1: Maximal Change From Baseline in Ventricular Rate Within 24 Hour Infusion|12-lead Holter monitors were placed on all participants within 45 minutes prior to dosing. Post dose measurements were made at 2, 4, 6, 8, 10, 20, 30, and 40 minutes and 1, 1.5, 2, 4, 6, 8, 12, 16, and 24 hours post-dose. To achieve consistent recording, Holter sampling will be recorded with the participant recumbent and at rest for at least 10 minutes prior to collection.|24 hours|Safety dataset included all participants who had received at least one dose of the trial medication.||beats/minute||Standard Deviation|Mean
686986|NCT01483183|Primary|Part 1:Maximal Change From Baseline in QT Interval Corrected for Heart Rate Using the Fridericia Formula (QTcF) Within 24 Hour Infusion|12-lead Holter monitors were placed on all participants within 45 minutes prior to dosing. Post dose measurements were made at 2, 4, 6, 8, 10, 20, 30, and 40 minutes and 1, 1.5, 2, 4, 6, 8, 12, 16, and 24 hours post-dose. To achieve consistent recording, Holter sampling will be recorded with the participant recumbent and at rest for at least 10 minutes prior to collection.|24 hours|Safety dataset included all participants who had received at least one dose of the trial medication.||msec||Standard Deviation|Mean
686987|NCT01483183|Primary|Part 1: Area Under the Concentration-time Curve From Time 0 to Time of the Last Measurable Concentration (AUCτ)|OPC-108459 was administered as a 10-minute constant rate IV infusion. Blood samples were collected pre-dose (within 45 minutes of dosing), at the end of infusion and 0.5, 1, 2, 4, 8 and 24 hours post infusion.|24 hours|PK analysis dataset included all participants who had concentration time profiles consistent with proper intravenous infusion.||μg∙h/mL||Standard Deviation|Mean
686988|NCT01483183|Primary|Part 1: Maximum (Peak) Plasma Concentration (Cmax)|OPC-108459 was administered as a 10-minute constant rate IV infusion. Blood samples were collected pre-dose (within 45 minutes of dosing), at the end of infusion and 0.5, 1, 2, 4, 8 and 24 hours post start of infusion.|24 hours|PK analysis dataset included all participants who had concentration time profiles consistent with proper intravenous infusion.||μg/mL||Standard Deviation|Mean
686989|NCT01483118|Secondary|Change in Glucose Response|Change in Glucose Response - area under the curve (AUC), trapezoidal method - in overweight patients with PCOS between baseline and after 6 months of daily cinnamon compared to the corresponding change in patient receiving 6 months of placebo. Fasting blood samples were drawn followed by a 2 hour glucose tolerance test with blood draws at 30, 60, and 120min post glucose ingestion.|Baseline and 6 Months - fasting bloods, followed by glucose tolerance test with draws at 30, 60, and 120 minutes post glucose ingestion|||mg/dL*min||Inter-Quartile Range|Median
686990|NCT01483118|Secondary|Change in Insulin Resistance|The changes in insulin resistance parameters in overweight patients with PCOS between baseline and after 6 months of daily cinnamon compared to the corresponding change in patients receiving 6 months of placebo. Higher values of insulin resistance represent a worse outcome. A higher value Homeostasis Model of Insulin Resistance indicates more insulin resistance so higher values are worse outcomes (a score of >2 is considered healthy for adults with scores >5 being considered severe insulin resistance). For the Quant. Insulin Sensitivity Check Index, a lower value indicates more insulin resistance so lower values are worse outcomes (values can range from .45, which is considered normal in health individuals and .30, which is characteristic of diabetes).|Baseline and 6 months|||Insulin sensitivity indices||Inter-Quartile Range|Median
686991|NCT01483118|Primary|Number of Menses During the Six Month Study Period.|Ovulatory cycles will be confirmed by serum progesterone levels.|Up to 6 months|||Number of menstrual cycles per month||Inter-Quartile Range|Median
686992|NCT01482910|Secondary|Percentage of Participants Who Lost Fewer Than 15 Letters at Week 28 – LOCF|Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better functioning.|At week 28|Full analysis set||Percentage of participants|||Number
686993|NCT01482910|Primary|Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by ETDRS Letter Score at Week 28 – Last Observation Carried Forward (LOCF)|Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better functioning.|Baseline and at week 28|Full analysis set||Letters correctly read||Standard Deviation|Mean
686994|NCT01482884|Secondary|Immunogenicity|Incidence of anti-drug antibodies (ADA) to tralokinumab in serum.|Pre-dose sampling at baseline, Week 8, 12, 16, and 24.|The safety analysis set consist of all randomised participants who received at least one dose of study medication.||participants|||Number
686995|NCT01482884|Secondary|Serum Concentration of Tralokinumab||Pre-dose sampling at baseline, Week 4, 8, 12, 16, 20, and 24.|The safety analysis set consist of all randomised participants who received at least one dose of study medication.||ug/ml||Full Range|Mean
686996|NCT01482884|Secondary|Change From Baseline in Calprotectin||From baseline to Week 4, 8, 12, 16, 20, and 24.|The full analysis set consist of all randomised participants||ug/g||Full Range|Mean
686997|NCT01482884|Secondary|Change From Baseline in Albumin||From baseline to Week 4, 8, 12, 16, 20, and 24.|The full analysis set consist of all randomised participants||g/L||Full Range|Mean
686998|NCT01482884|Secondary|Change From Baseline in C - Reactive Protein||From baseline to Week 4, 8, 12, 16, 20, and 24.|The full analysis set consist of all randomised participants||mg/L||Full Range|Mean
686999|NCT01482884|Secondary|Change From Baseline in Modified Riley Score|Modified Riley score is biopsy grade which range from 0-5; where 0: Normal mucosa, 1: Infiltration of lymphocytes and plasma cells in the lamina propria, 2: Infiltration of neutrophils and eosinophils in the lamina propria, 3: Infiltration of neutrophils in the epithelium, 4: Crypt destruction, 5: Erosion and/or ulceration.|Eight week treatment period|The full analysis set consist of all randomised participants however the numbers for the endpoints mentioned for this secondary outcome are lower due to missing data.||Grade on scale||Standard Error|Least Squares Mean
687062|NCT01481740|Secondary|Incidence of Hypotension||intraoperative - predelivery|||participants|||Number
687000|NCT01482884|Secondary|Change From Baseline in Partial Mayo Score|The partial Mayo score is the sum of the three sub-score areas: stool frequency, rectal bleeding, and the physician’s global assessment.The partial Mayo score ranges from 0-9, with higher scores indicating a more severe disease. Change from baseline: Mayo score at each post-baseline timepoint (week 4, 8, 12, 16, 20, and 24) minus the Mayo score at baseline.|From baseline to Week 4, 8, 12, 16, 20, and 24.|The full analysis set consist of all randomised participants||Score on scale||Full Range|Mean
687001|NCT01482884|Secondary|Clinical Remission at Week 8 Based on Mayo Score|Participants were classified as in remission if Mayo score of ≤2 with no individual sub score exceeding 1 point. Mayo score is sum of four sub-scores: stool frequency, rectal bleeding, endoscopy findings and the physician’s global assessment. The total Mayo score ranges from 0-12, with higher scores indicating a more severe disease.|Eight week treatment period|The full analysis set consist of all randomised participants||Percentage of participants|||Number
687002|NCT01482884|Secondary|Mucosal Healing at Week 8 Based on Mayo Score|Improvement of the endoscopy sub score (from the Mayo score) from 3 or 2 to 0 or 1 point, or from 1 to 0 points.|Eight week treatment period|The full analysis set consist of all randomised participants||Percentage of participants|||Number
687003|NCT01482884|Secondary|Change in Mayo Score From Baseline to Week 8|Mayo score is sum of four sub-scores: stool frequency, rectal bleeding, endoscopy findings and the physician’s global assessment. The total Mayo score ranges from 0-12, with higher scores indicating a more severe disease. Change from baseline: Mayo score at week 8 minus the Mayo score at baseline.|Eight week treatment period|The full analysis set consist of all randomised participants however the numbers for the endpoints mentioned for this secondary outcome are lower due to missing data.||Score on scale||Standard Error|Least Squares Mean
687004|NCT01482884|Primary|Clinical Response at Week 8 Based on Mayo Score|Clinical response was measured as a decrease in Mayo score of ≥3 points from baseline, decrease in the total Mayo score from baseline ≥30 percentage and a decrease in the sub score for rectal bleeding ≥1 or absolute sub score for rectal bleeding of 0 or 1 point. Mayo score is sum of four sub-scores: stool frequency, rectal bleeding, endoscopy findings and the physician’s global assessment. The total Mayo score ranges from 0-12, with higher scores indicating a more severe disease.|Eight week treatment period|The full analysis set consist of all randomised participants||Percentage of responders|||Number
687005|NCT01482819|Primary|Endothelia Blebs|0 to 100% of area; measured as a percentage of corneal area with blebs.|after 20 minutes of lens wear|Subjects who were enrolled, randomized and completed the study.||percentage of area|eyes|Standard Deviation|Mean
687006|NCT01482819|Primary|Limbal Redness|grade scale of 0 to 4, where 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe; reported as an average grade.|after 8 hours of lens wear|Subjects who were enrolled, randomized, and completed the study.||units on a scale|eyes|Standard Deviation|Mean
687007|NCT01482819|Primary|Corneal Swelling|measured in microns using the Optical Low Coherence Reflectometry (OLCR) Pachymeter. This pachymeter gives corneal thickness measurements to the accuracy of 1 micron (µm)|after 8 hours of lens wear|Subjects who were enrolled, randomized, and completed the study. One eye from each subject was measured.||microns|eyes|Standard Deviation|Mean
687008|NCT01482767|Secondary|Number of Participants With Grade 2 or Higher Signs and Symptoms and Laboratory Abnormalities and Other Serious AEs|This outcome measure was intended for a potential interim analysis when study data up to Week 28 were complete. However, this interim analysis was not conducted. Refer to Outcome Measure 2 above for the safety outcome that includes the whole study duration from entry to week 72.|From study treatment dispensation to Week 28|This outcome measure was intended for a potential interim analysis which was not conducted.|||||
687009|NCT01482767|Secondary|Number of Participants With Undetectable HCV RNA at Week 16, 20, 24 and 28 Study Visits|Undetectable HCV RNA was defined as below the lower limit of quantitation of the assay and target not detected by Roche COBAS® TaqMan® HCV Test v2.0. This outcome measure was intended for a potential interim analysis when study data up to Week 28 were complete. However, this interim analysis was not conducted.|Weeks (W) 16, 20, 24, and 28|This outcome measure was intended for a potential interim analysis which was not conducted.|||||
687010|NCT01482767|Secondary|Number of Participants With Undetectable HCV RNA at Week 4, 8 and 12 Study Visits|Undetectable HCV RNA was defined as below the lower limit of quantitation of the assay and target not detected by Roche COBAS® TaqMan® HCV Test v2.0.|Weeks (W) 4, 8, 12|All eligible participants with HCV RNA result available at the respective visit (numbers of participants in Category Titles below; n). Participants who discontinued treatment early due to HCV virologic failure, safety or any other reason started following a separate visit schedule and are not included here.||participants|||Number
687011|NCT01482767|Secondary|CD4+ T-Cell Count (CD4) Change From Baseline|Change in CD4 T-cell count was calculated as value at the post entry visit minus the value at entry.|Entry and weeks (W) 8, 12, 24, 28, 40, 48, 52, 60, 72|All eligible participants enrolled with CD4 result available from entry and the respective post-entry visit (numbers of participants in Category Titles below; n). Participants who discontinued treatment early due to HCV virologic failure, safety or any other reason started following a separate visit schedule and are not included here.||cells/mm^3||Inter-Quartile Range|Median
687012|NCT01482767|Secondary|Percentage of Participants With HIV-1 Viral Load <50 Copies/mL|HIV-1 RNA testing was performed with Abbott RealTime HIV-1 assay (LLOQ=40 copies/mL) or with Roche COBAS AmpliPrep/Taqman HIV-1 assay (LLOQ=20 copies/mL).|Entry and weeks (W) 4, 8, 12, 24, 28, 40, 48, 52, 60, 72|All eligible participants with HIV-1 RNA result available at the respective visit (numbers of participants in Category Titles below; n). Participants who discontinued treatment early due to HCV virologic failure, safety or any other reason started following a separate visit schedule and are not included here.||percentage of participants|||Number
687013|NCT01482767|Secondary|Percentage of Participants With Sustained Virologic Response at 12 Weeks After Treatment Discontinuation (SVR12)|SVR12 was defined as undetectable HCV RNA (below the lower limit of quantitation of the assay and target not detected by Roche COBAS® TaqMan® HCV Test v2.0) at 12 weeks after treatment discontinuation. Participants without HCV RNA for SVR12 determination were considered not to have achieved SVR12.|12 weeks after treatment discontinuation|All eligible participants enrolled (Group B participants who were found ineligible after enrollment, n=5, were excluded).||percentage of participants||95% Confidence Interval|Number
687063|NCT01481740|Primary|Incidence of Nausea and Vomiting||24hrs postoperative|||participants|||Number
687064|NCT01481740|Primary|Incidence of Nausea and Vomiting||2 hrs postoperative|||participants|||Number
687014|NCT01482767|Secondary|Percentage of Participants With Grade 3 or Higher Adverse Events (AEs)|Number of participants who experienced an AE (sign or symptom or laboratory abnormality) of Grade 3 or higher at any time after baseline while on study. The AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (see references in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening.|From study treatment dispensation to Week 72|All eligible participants enrolled (Group B participants who were found ineligible after enrollment, n=5, were excluded).||percentage of participants||95% Confidence Interval|Number
687015|NCT01482767|Primary|Percentage of Participants With Sustained Virologic Response at 24 Weeks After Treatment Discontinuation (SVR24)|SVR24 was defined as undetectable HCV RNA (below the lower limit of quantitation of the assay and target not detected by Roche COBAS® TaqMan® HCV Test v2.0) at 24 weeks after treatment discontinuation. Participants without HCV RNA for SVR24 determination were considered not to have achieved SVR24.|24 weeks after treatment discontinuation|All eligible participants enrolled (Group B participants who were found ineligible after enrollment, n=5, were excluded).||percentage of participants||95% Confidence Interval|Number
687016|NCT01482429|Primary|Length of Intensive Care Unit Stay||days||||||
687017|NCT01482429|Primary|Duration of Mechanical Ventilation||days||||||
687018|NCT01482429|Primary|Duration of Weaning From Mechanical Ventilation||days|overall||days||Standard Deviation|Mean
687019|NCT01482429|Primary|Mortality||length of ICU stay (days)|Overall||participants|||Number
687020|NCT01482325|Primary|Data Collection for Engineering Development|"This was a data collection for engineering development to demonstrate SuperSTAT 2.0 NIBP software algorithm meets the engineering specifications. Engineers reviewed data produced by each blood pressure determination to work on new software algorithm in development. This was not conducted as program was terminated prematurely.
Software iterations are not pre-defined."|After each iteration of software development|Subject analysis was not performed because study was prematurely terminated. Work on the project ceased when it was terminated.The study was intended to have the engineers review data produced by each blood pressure determination to work on new software algorithm in development. This was not and will not be conducted.|||||
687021|NCT01482312|Primary|Ocular Comfort|Ocular comfort was assessed by the participant after 90 minutes in the LHE and quantified as a linear measure (cm) on a modified Visual Analog Scale (VAS) of 0-20 cm, with a higher number indicating greater perceived comfort.|90 minutes|As treated.||cm|Participants|Standard Deviation|Median
687022|NCT01482312|Primary|Tear Osmolarity|The participant spent 90 minutes in the LHE (low humidity environment) chamber, after which tears were sampled from the lower tear meniscus (thin strip of tear fluid at the lower lid margin) and tear osmolarity was measured using a TearLab osmometer, a device that measures the osmolarity of human tears to aid in the diagnosis of dry eye disease. Tear osmolarity is the measure of solid particles (salt) in a solution (tears), and a higher number can be indicative of dry eye disease, while a lower number is generally indicative of the normal tear osmolarity.|90 minutes|As treated.||mOsms/L|Participants|Standard Deviation|Mean
687023|NCT01482221|Secondary|Change From Baseline in Self-rated Severity of Depressive Symptoms as Measured by Quick Inventory of Depressive Symptomatology Self-Rated 16-item Scale (QIDS-SR-16) Total Score|A 16-question self-report inventory that includes the 9 Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria symptom domains: sad mood, concentration, self-outlook, suicidal ideation, involvement, energy/fatigability, sleep disturbance (4 items: initial, middle, late insomnia, and hypersomnia), appetite/weight increased or decrease (4 items), and psychomotor agitation/retardation (2 items). The QIDS-SR-16 total scores range from 0 (least severe) to 27 (most severe).|Baseline to Week 12|The mITT analysis set included all randomized patients, who took IP and who have a non-missing baseline MADRS total score and at least 1 post-baseline MADRS total score, classified according to their randomized treatment.||units on a scale||Standard Error|Least Squares Mean
687024|NCT01482221|Secondary|Change in Severity of Depressive Symptoms as Measured by the CGI-I Response (Defined as CGI-I Rating of “Very Much Improved” or “Much Improved”) at Week 12|A 3-part, clinician-administered scale that rates the improvement or worsening of the patient's illness from randomization (baseline). Each item is scored on a 1 to 7 scale. CGI-I scores >4 indicate worsening, while scores <4 indicate improvement.|Baseline to Week 12|The mITT analysis set included all randomized patients, who took IP and who have a non-missing baseline MADRS total score and at least 1 post-baseline MADRS total score, classified according to their randomized treatment.||percentage of participants analyzed|||Number
687025|NCT01482221|Secondary|Change in Severity of Depressive Symptoms as Measured by the CGI-I Response (Defined as CGI-I Rating of “Very Much Improved” or “Much Improved”) at Week 6|A 3-part, clinician-administered scale that rates the improvement or worsening of the patient's illness from randomization (baseline). Each item is scored on a 1 to 7 scale. CGI-I scores >4 indicate worsening, while scores <4 indicate improvement.|Baseline to Week 6|The mITT analysis set included all randomized patients, who took IP and who have a non-missing baseline MADRS total score and at least 1 post-baseline MADRS total score, classified according to their randomized treatment.||percentage of participants analyzed|||Number
687026|NCT01482221|Secondary|Change in Severity of Depressive Symptoms as Measured by Change From Baseline in the Clinical Global Impression-Severity (CGI-S) Score|Clinical Global Impression - Severity (CGI-S) scale rates the severity of the patient’s illness at the time of assessment, range from 1 (normal, not ill) to 7 (very severely ill).|Baseline to Week 12|The mITT analysis set included all randomized patients, who took IP and who have a non-missing baseline MADRS total score and at least 1 post-baseline MADRS total score, classified according to their randomized treatment.||units on a scale||Standard Error|Least Squares Mean
687027|NCT01482221|Secondary|Change From Baseline in Functional Impairment as Measured by the Change From Baseline in the Sheehan Disability Scale (SDS) Total Score|A 3-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The SDS total score is calculated as the sum of the score for the 3 intercorrelated domains (school/work, social life, and family life/home responsibilities), ranges from 0 (no impairment) to 30 (most severe impairment).|Baseline to Week 12|The mITT analysis set included all randomized patients, who took IP and who have a non-missing baseline MADRS total score and at least 1 post-baseline MADRS total score, classified according to their randomized treatment.||units on a scale||Standard Error|Least Squares Mean
687065|NCT01481740|Primary|Incidence of Nausea and Vomiting||intraoperative|||participants|||Number
687029|NCT01482221|Secondary|Percentage of Patients Who Were Remitted (Defined as MADRS Total Score ≤10) at Week 6|The percentage of patients who were Remitted (defined as MADRS total score ≤10) was calculated.|Baseline to Week 6|The mITT analysis set included all randomized patients, who took IP and who have a non-missing baseline MADRS total score and at least 1 post-baseline MADRS total score, classified according to their randomized treatment.||percentage of participants analyzed|||Number
687030|NCT01482221|Secondary|Percentage of Patients Who Were Responders (Defined as a ≥50% Reduction From Baseline in MADRS Total Score) at Week 12|The percentage of patients who were Responders (defined as ≥50% reduction from baseline in MADRS total score) was calculated.|Baseline to Week 12|The mITT analysis set included all randomized patients, who took IP and who have a non-missing baseline MADRS total score and at least 1 post-baseline MADRS total score, classified according to their randomized treatment.||percentage of participants analyzed|||Number
687031|NCT01482221|Secondary|Percentage of Patients Who Were Responders (Defined as a ≥50% Reduction From Baseline in MADRS Total Score) at Week 6|The percentage of patients who were Responders (defined as ≥50% reduction from baseline in MADRS total score) was calculated.|Baseline to Week 6|The mITT analysis set included all randomized patients, who took IP and who have a non-missing baseline MADRS total score and at least 1 post-baseline MADRS total score, classified according to their randomized treatment.||percentage of participants analyzed|||Number
687032|NCT01482221|Secondary|Percentage of Patients With Sustained Response From Week 6 to Week 12 (Defined as ≥50% Reduction From Baseline in the MADRS Total Score at Week 6 and Which is Maintained Through Week 12)|The percentage of patients with with Sustained Response (defined as ≥50% reduction from baseline in the MADRS total score at Week 6 and which is maintained through Week 12) was calculated.|Week 6 to Week 12|The mITT analysis set included all randomized patients, who took IP and who have a non-missing baseline MADRS total score and at least 1 post-baseline MADRS total score, classified according to their randomized treatment.||percentage of participants analyzed|||Number
687033|NCT01482221|Secondary|Change From Baseline to Week 12 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Baseline to Week 12|The modified intent-to-treat (mITT) analysis set included all randomized patients, who took IP and who have a non-missing baseline MADRS total score and at least 1 post-baseline MADRS total score, classified according to their randomized treatment.||units on a scale||Standard Error|Least Squares Mean
687034|NCT01482221|Primary|Change From Baseline to Week 6 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Baseline to Week 6|The modified intent-to-treat (mITT) analysis set included all randomized patients, who took investigational product (IP) and who have a non-missing baseline MADRS total score and at least 1 post-baseline MADRS total score, classified according to their randomized treatment.||units on a scale||Standard Error|Least Squares Mean
687035|NCT01482091|Secondary|Hypoxia|Number of participants who had hypoxia within 30 min of study drug adminsitration|Every 5 minutes until 30 minutes after study drug administration|||participants|||Number
687036|NCT01482091|Secondary|Hypotension|Participants who had hypotension within 30 min of study drug administration|Every 5 minutes until 30 minutes after study drug administration|||participants|||Number
687037|NCT01482091|Secondary|Respiratory Distress|Participants who had respiratory distress within 30 min of study drug administration|Every 5 minutes until 30 minutes after study drug administration|||participants|||Number
687038|NCT01482091|Secondary|Change in Pain Score|Due to confounding factors we were unable to obtain reliable data for this outcome|Baseline and immediately prior to IV insertion||||||
687039|NCT01482091|Secondary|Change in Pain Score at 30 Minutes|"Change in pain score between 0 and 30 minutes using the Wong Baker FACES pain scale (WBFPS). The WBFPRS has six faces, with each face representing an increasing severity of pain the more rightward it is on the scale (0 is the lowest score, which represents the least amount of pain, while 10 is the highest score which represents the greatest level of pain).. Each face has an even number underneath it, consecutively.
To calculate the change, the reported pain score at 30 minutes was subtracted from the reported baseline pain score. Thus, the higher change in pain score is indicative of a GREATER change in pain (i.e. greater decrease in pain at 30 minutes compared to baseline). The greatest possible changes in pain would be a 10 (pain score of 10 at baseline and 0 at 30 minutes) representing a DECREASE in pain between the two time points, and -10 (pain score of 0 at baseline and 10 at 30 minutes) representing a INCREASE in pain between the two time points."|Baseline and 30 minutes after administration of study drug|||units on a scale||Inter-Quartile Range|Median
687040|NCT01482091|Secondary|Change in Pain Score at 10 Minutes|"Change in pain score between 0 and 10 minutes using the Wong Baker FACES pain scale (WBFPS). The WBFPRS has six faces, with each face representing an increasing severity of pain the more rightward it is on the scale (0 is the lowest score , which represents the least amount of pain, while 10 is the highest score which represents the greatest level of pain).. Each face has an even number underneath it, consecutively.
To calculate the change, the reported pain score at 10 minutes was subtracted from the reported baseline pain score. Thus, the higher change in pain score is indicative of a GREATER change in pain (i.e. greater decrease in pain at 10 minutes compared to baseline). The greatest possible changes in pain would be a 10 (pain score of 10 at baseline and 0 at 10 minutes) representing a DECREASE in pain between the two time points, and -10 (pain score of 0 at baseline and 10 at 10 minutes) representing a INCREASE in pain between the two time points."|Baseline and 10 minutes after administration of study drug|||units on a scale||Inter-Quartile Range|Median
687041|NCT01482091|Secondary|Time to Study Drug Administration||Time from triage to adminstration of study drug|||minutes||Standard Deviation|Mean
687042|NCT01482091|Secondary|Total Amount of Narcotics Administered|Given multiple confounding and extraneous factors, reliable data was not able to be obtained for this outcome measure|Participants will be followed for the duration of their ED visit, an expected average of 6 hours||||||
687043|NCT01482091|Secondary|Length of Stay in ED|Given multiple confounding factors, reliable data was not able to be obtained for this outcome measure|Time from triage until either discharge from the ED or admission to an inpatient unit, an expected average of 6 hours||||||
687047|NCT01482091|Primary|Change in Pain Score 20 Minutes After Administration of Study Drug|"Change in pain score between 0 and 20 minutes using the Wong Baker FACES pain scale (WBFPS). The WBFPRS has six faces, with each face representing an increasing severity of pain the more rightward it is on the scale (0 is the lowest score , which represents the least amount of pain, while 10 is the highest score which represents the greatest level of pain).. Each face has an even number underneath it, consecutively.
To calculate the change, the reported pain score at 20 minutes was subtracted from the reported baseline pain score. Thus, the higher change in pain score is indicative of a GREATER change in pain (i.e. greater decrease in pain at 20 minutes compared to baseline). The greatest possible changes in pain would be a 10 (pain score of 10 at baseline and 0 at 20 minutes) representing a DECREASE in pain between the two time points, and -10 (pain score of 0 at baseline and 10 at 20 minutes) representing a INCREASE in pain between the two time points."|Baseline and 20 minutes after administration of study drug|||units on a scale||Inter-Quartile Range|Median
687048|NCT01482065|Secondary|MRI Indices||6 Months|We were not able to obtain MRI data from 2 people within the CPAP group at 6 months. One withdrew from study and the other a clear scan could not be obtained.||percentage of fat in liver||Standard Deviation|Mean
687049|NCT01482065|Secondary|Analysis of Variance (ANOVA) in CPAP Versus No-CPAP Therapy on NAFLD|we will test our hypothesis that CPAP therapy improves NAFLD. The main independent variables will be CPAP vs. deferred-CPAP therapy. In a subanalysis, responses in the CPAP treatment group will be compared based on compliance. Compliance with CPAP is defined as using it on > 70% of the days, at least 4 h per night. Our primary outcome will be serum activity of ALT and AST. We will use ANOVA to examine changes in ALT and AST depending on CPAP therapy group and compliance. Secondary outcomes will include the degree of hepatic steatosis and fibrosis, as assessed by MRI.|6 months|We were unable to achieve enrollment goals due to limited clinical indications. Thereby not obtaining enough participant data to do an Analysis of Variance (ANOVA).|||||
687050|NCT01482065|Secondary|Liver Values|Serum Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) activity.|6 Months|Withdrawal by subject in CPAP group.||U/L||Standard Deviation|Mean
687051|NCT01482065|Primary|Cross Sectional Analysis of NAFLD Versus Sleep Apnea Severity Indices (AHI)|Cross-sectional analysis will be performed in NAFLD study participants from the Johns Hopkins (JH) Hepatology Clinic to examine the relationship between findings on liver biopsy and sleep apnea severity indices. The main predictor variable will be presence/severity of OSA and nocturnal oxyhemoglobin desaturation (assessed by T90%, time w/ oxyhemoglobin desaturation < 90%; Delta SaO2 between baseline and minimal oxyhemoglobin saturation, and standard deviation of nocturnal SaO2). Our primary outcome will be NAFLD activity score on biopsy.|6 months|We were unable to obtain liver biopsy on most of our participants due to limited clinical indications.|||||
687052|NCT01481935|Primary|Contamination of Disposable Isolation Gown and Gloves With Methicillin-resistant Staphylococcus Aureus or Multi-drug-resistant Acinetobacter Baumannii|Swabs will be collected from the disposable gown and gloves of healthcare workers exiting the enrolled room. A single swab will be used for both gloves and the gown. The swab will be assayed for methicillin-resistant Staphylococcus aureus, multi-drug-resistant Acinetobacter baumannii, or both, depending on which organism(s) the occupant of the enrolled room is colonized with. The swab will be considered positive if the relevant organism is isolated. We will sample the first 15 healthcare worker exits after the room has received the allocated intervention.|As a healthcare worker exits the enrolled room (1 day)|Unit of analysis was the ICU room. Results from multiple participants who occupied a single room over the course of the trial were summarized by room.||percentage of positive cultures|Participants|Standard Error|Mean
687053|NCT01481896|Secondary|Patient Satisfaction Per Hip|Whether or not an individual is satisfied with the outcome of their hip arthroplasty is evaluated using a questionnaire. Since a participant with both hips replaced could have a different level of satisfaction for each hip, patient satisfaction is reported per hip.|At a mean of 5.6 years after primary total hip arthroplasty|||number of participants|Participants||Number
687054|NCT01481896|Secondary|Component Revision Per Hip|For implants that require a component revision, the reason for the revision is determined based on the pre-operative history and operative findings at the time of revision. Since a participant with both hips replaced could have a revision of each hip, component revision is reported per hip.|At a mean of 6.7 years after primary total hip arthroplasty|||number of hips|Participants||Number
687055|NCT01481896|Secondary|Implant Stability Per Hip|Implant stability is classified and stable/bone ingrown, fibrous fixed or loose and evaluated using conventional radiographs. Since a participant with both hips replaced could have a different type of stability for each hip, implant stability is reported per hip.|At a mean of 5.6 years after primary total hip arthroplasty|All hips that had a follow-up x-ray taken at least 4.75 years after their joint replacement were included.||number of hips|Participants||Number
687056|NCT01481896|Secondary|Osteolysis Per Hip|Osteolysis is defined as localized areas of peri-prosthetic bone loss that did not exist prior to surgery and is evaluated using radiographs and CT scans. Since a participant with both hips replaced could have a osteolysis present or absent for each hip, osteolysis is reported per hip.|At a mean of 5.6 years after primary total hip arthroplasty|Patients who had radiographs or computed tomography (CT) scans taken as part of routine care were included.||Number of hips with osteolysis|Participants||Number
687057|NCT01481896|Secondary|Harris Hip Score Per Hip|Harris Hip Scores are derived from a patient questionnaire and physical examination. Since a participant with both hips replaced could have different Harris Hip Scores for each hip, the Harris Hip Scores are reported per hip.|At a mean of 5.6 years after primary total hip arthroplasty|||units on a scale|Participants|Full Range|Median
687058|NCT01481896|Secondary|Cup Orientation Per Hip|Cup orientation including abduction and anteversion is determined using follow-up radiographs. Since a participant with both hips replaced could have different cup orientations for each hip, cup abduction and anteversion angles are reported per hip.|On the first post-operative anteroposterior pelvic radiograph after primary total hip arthroplasty|Cup orientation was measured for all 131 total hip replacements included in the study population.||degrees|Participants|Full Range|Median
687059|NCT01481896|Primary|Metal Ion Levels Per Participant|Metal ion levels include cobalt and chromium ion levels determined from tests of blood samples. Metal ion levels are reported per participant since blood samples were taken from individual participants who could have had one or both hips replaced.|At a mean of 4.2 years after primary total hip arthroplasty|Patients who had blood drawn and analyzed for serum cobalt levels as part of routine care are included.||micrograms per liter||Full Range|Median
687066|NCT01481558|Primary|Apathy Symptoms|Apathy evaluated by Apathy Scale by Starsktein et al, 1992, which consists of 14 items phrased as questions that are to be answered by the caregiver on a four-point Likert scale. The total score range from 0 to 42, with higher scores indicating greater apathy severity. Apathy was assessed at baseline and at the end of the sixth session (second week).|Differences in outcome measure comparing second week to baseline|"alpha=5%, power=80%, SD estimated at 8 on Apathy scale scores, and correlation coefficient estimated at 0.7, a sample with 20 participants per arm is required to detect a between-group effect size of 0.5.
Intention to treat (ITT) analyses were conducted using the method of last observation carried forward (LOCF) for missing data."||units on a scale||95% Confidence Interval|Mean
687067|NCT01481376|Secondary|Hospital Length of Stay||Duration of the hospital stay (expected average of 1 day)|||Days||Standard Deviation|Mean
687068|NCT01481376|Secondary|Operative Time||From skin incision to closure (The expected median operating time is 36 minutes for unilateral and 50 minutes for bilateral repair)||||||
687069|NCT01481376|Secondary|Patient Satisfaction||at least 12 month post-operatively|||participants|||Number
687070|NCT01481376|Secondary|Postoperative Complications Including, Infection, Seroma, Hematoma, Visceral Adherence, Allergy Etc||up to 12 months|||participants|||Number
687071|NCT01481376|Secondary|Analgesic Use||The day of the discharge (an expected average of 1 day), 1month and at least 12 month post-operatively||||||
687072|NCT01481376|Secondary|Incidence of Groin Pain (Pain Score 0-10)||12 month post-operatively|||participants|||Number
687073|NCT01481376|Primary|Proportion of Subjects Who Experience Hernia Recurrence (Defect Treated Initially With Parietex™ ProGrip™) Within 12 Months Post-surgery.|Recurrence is defined as a clinically manifest bulge or a protrusion exacerbated by a Valsalva maneuver in the operated groin. The recurrence symptoms are assessed by phone based on the Symptoms Questionnaire and the recurrence diagnosis is confirmed during a physical examination by a physician.|At least 12 months post-surgery|||participants|||Number
687074|NCT01481324|Primary|Wear Rate Percentage (Number of Hours Per Day Brace Was Worn Out of the Recommended 24 Hours)|Number of hours per day in brace will be measured by pressure sensor at the end of month 1, month 2 and month 3. Parent report of brace wear will also be documented at each of these timepoints. Wear rate percentage will be calculated by dividing the number of hours of brace wear (either actual as measured by the sensor or reported by parent diary) by the recommended 24 hours.|3 months|||percentage of time worn||Full Range|Mean
687075|NCT01481129|Secondary|Toxicity as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0||Up to 30 days|||Participants|||Count of Participants
687076|NCT01481129|Secondary|Progression-free Survival (PFS)|Analyzed using the Kaplan-Meier method. The median survival rates will be reported with a 95% confidence interval. Median follow-up will be calculated using the reverse Kaplan-Meier method.|From the date of inclusion to the date of first documented disease progression, relapse or death from any cause, assessed up to 4 years|||months||95% Confidence Interval|Median
687077|NCT01481129|Secondary|Overall Survival|Analyzed using the Kaplan-Meier method. The median survival rates will be reported with a 95% confidence interval. Median follow-up will be calculated using the reverse Kaplan-Meier method.|From the date of inclusion to the date of death from any cause, assessed up to 4 years|||months||95% Confidence Interval|Median
687078|NCT01481129|Secondary|Duration of Response|Described in responding subjects using descriptive statistics (median, extreme values, etc.).|up to 4 years|No responses were observed|||||
687079|NCT01481129|Primary|Objective Response Rate According to the International Response Criteria for DLBCL (Cheson 2007)|Rate of CR + PR according to Cheson 2007 after 4 months of treatment|Up to 4 months|||objective response|||Number
687080|NCT01481116|Secondary|Change From Baseline in Fasting Plasma Glucose at Weeks 26, 52, 78 and 104|The change between the fasting plasma glucose value to be collected at Weeks 26, 52, 78 and 104 relative to baseline.|Baseline and Weeks 26, 52, 78 and 104|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had a baseline and at least 1 post- baseline value during the double-blind treatment period.||milligram per deciliter (mg/dL)||Standard Error|Least Squares Mean
687081|NCT01481116|Secondary|Percentage of Participants With HbA1c <7% for Participants Who Did Not Report Hypoglycemia||Weeks 26, 52, 78 and 104|Data for this outcome measure was not analyzed as prespecified in the protocol.|||||
687082|NCT01481116|Secondary|Percentage of Participants With HbA1c <7%||Weeks 26, 52, 78 and 104|FAS included all randomized subjects who received at least 1 dose of double-blind study medication and who had a baseline and at least 1 post- baseline value during the double-blind treatment period.||percentage of participants|||Number
687083|NCT01481116|Secondary|Change From Baseline in HbA1c at Weeks 26 and 52|The change in the value of HbA1c collected at Weeks 26 and 52 relative to baseline.|Baseline and Weeks 26 and 52|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had a baseline and at least 1 post- baseline value during the double-blind treatment period.||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
687084|NCT01481116|Secondary|Change From Baseline in Body Weight at Weeks 78 and 104|The change between the body weight to be collected at Weeks 78 and 104 relative to baseline.|Baseline and Weeks 78 and 104|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had a baseline and at least 1 post- baseline value during the double-blind treatment period. Data for body weight was not available at Week 104 due to early termination of the study.||kg||Standard Error|Least Squares Mean
687085|NCT01481116|Secondary|Percentage of Participants With Hypoglycemia|Participants were provided diaries to document any hypoglycemic events that occurred between study visits. Any experience of hypoglycemic signs and symptoms (regardless of the blood glucose value by glucometer) or had a blood glucose value less than or equal to (<=) 70 milligram per deciliter (mg/dL) (3.9 millimole per liter (mmol/L) by glucometer (regardless of symptoms) were to be recorded.|Day 1 up to Weeks 78 and 104|Safety analysis set included all participants who received at least 1 dose of double-blind study medication. Participants were analyzed according to the study medication they received.||percentage of participants|||Number
687125|NCT01480284|Secondary|Number of Participants With Serum HBV DNA < 2.1 log10 Copies/mL at Week 24, Week 48 and Week 96|The number of participants with serum HBV DNA level less than the lower limit of quantitation (i.e. 2.1 log10 copies/mL) at Week 24, Week 48 and Week 96 were summarized. The LOCF method was applied for missing values.|Week 24, Week 48 and Week 96|FAS Population||Participants|||Number
687086|NCT01481116|Primary|Change From Baseline in HbA1c at Weeks 78 and 104|The change in the value of HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) to be collected at Weeks 78 and 104 relative to baseline.|Baseline and Weeks 78 and 104|Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of double-blind study medication and who had a baseline and at least 1 post- baseline assessment.||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
687087|NCT01480674|Secondary|The Duration of Treatment of Trastuzumab|Total treatment duration and duration of the first line of treatment is reported.|Up to 1 Year|Analyzed Set population included all enrolled participants without any protocol deviation used as a primary analysis population for all efficacy outcome measures.||Years||Standard Deviation|Mean
687088|NCT01480674|Secondary|Number of Participants With Any Adverse Events and Serious Adverse Events|An adverse event (AE) was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. The data was reported for prospective period.|Up to 1 year|The safety population set included of all participants who received at least one dose of study drug. Participants with available data in the prospective period were analysed.||Participants|||Number
687089|NCT01480674|Secondary|Number of Participants With Antineoplastic Treatment in Combination With Trastuzumab and After Discontinuation of Trastuzumab Treatment|Antineoplastic treatment given in combination with and after discontinuation (Aft. Dis) of herceptin treatment included chemotherapy and hormonotherapy.|Up to 12 years|Analyzed set population included all enrolled participants without any protocol deviation. This population set was used as a primary analysis population for all efficacy outcome measures. Participants with available data at specified time points are denoted as ‘n’.||Participants|||Number
687090|NCT01480674|Secondary|Dosage Schedule of Herceptin Treatment|Participants who received trastuzumab are reported in the below table. The regimen of trastuzumab in first line treatment is presented as in frequency 1 infusion (inf) per week (W) and dose per infusion as mg/kg.|Up to 12 years|Analyzed set population included all enrolled participants without any protocol deviation. This population set was used as a primary analysis population for all efficacy outcome measures. Participants with available data at specified time points are denoted as ‘n’.||Participants|||Number
687091|NCT01480674|Secondary|Overall Survival|The overall survival (OS) was defined as the time between the treatment start date (date of the first trastuzumab infusion during the metastatic period) and the death from any cause.|Up to 12 years|Analyzed set population included all enrolled participants without any protocol deviation. This population set was used as a primary analysis population for all efficacy outcome measures.||Years||95% Confidence Interval|Median
687092|NCT01480674|Secondary|Time to Progression|The Time to progression (TTP) was defined as the time between the treatment start date (date of the first trastuzumab infusion during the metastatic period) and the date of the first progressive disease.|Up to 12 years|Analyzed set population included all enrolled participants without any protocol deviation. This population set was used as a primary analysis population for all efficacy outcome measures.||Years||95% Confidence Interval|Median
687093|NCT01480674|Secondary|Progression-free Survival|The Progression-free survival (PFS) was defined as the time between the treatment start date (date of first trastuzumab infusion during the metastatic period) and the date of the first progressive disease or death from any cause. The method of assessment of disease progression was not outlined within the protocol, this was completed by each investigator in line with routine practice.|Up to 12 years|Analyzed set population included all enrolled participants without any protocol deviation. This population set was used as a primary analysis population for all efficacy outcome measures.||Years||95% Confidence Interval|Median
687094|NCT01480674|Primary|Percentage of Participants With Prevalence of Bone Metastases Without Progression for at Least 3 Years After the Beginning of 1st Line Herceptin Treatment|Bone metastasis occurs when cancer cells spread from their original site to a bone. Percentage of participants with prevalence of bone metastases without progression were reported|Up to 3 years|Analyzed set population included all enrolled participants without any protocol deviation. This population set was used as a primary analysis population for all efficacy outcome measures. Participants with available data at the time of evaluation were reported.||Percentage of participants||95% Confidence Interval|Number
687095|NCT01480674|Primary|Tumor Hormone Receptor Status of Participants Without Progression|The clinical and tumor characteristics including HER2 and Hormone Receptor (HR) status of metastatic breast cancer participants are analysed which are important factors which impact on Progression Free Survival.|Up to 3 years|Analyzed set population included all enrolled participants without any protocol deviation. This population set was used as a primary analysis population for all efficacy outcome measures. Participants with available data at the time of evaluation were reported.||Percentage of participants||95% Confidence Interval|Number
687096|NCT01480596|Secondary|Mean Change From Baseline in the Myasthenia Gravis Activities of Daily Living Scale (MG-ADL) at Week 28, Week 32 and Week 36|The total MG-ADL score was calculated by adding the score of each of the 8 individual MG-ADL questions. Possible total MG-ADL scores range from 0 (normal) to 24 (severe). A lower score indicates a better clinical outcome. Baseline is defined as the participant's last available assessment prior to initiation of study IV infusion. Change from Baseline was calculated by subtracting the Baseline value from the post-Baseline value. The differences in adjusted least square means are presented (Belimumab 10 mg/kg minus Placebo). A negative treatment difference indicates benefit relative to placebo. The analysis method was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline MG-ADL Score, Treatment by Visit, and Baseline MG-ADL Score by Visit. Only follow-up visits are presented but the analysis also includes all treatment phase visits. Only those participants available at the indicated time points (represented by n=X in the category titles) were analyzed.|Baseline, Week 28, Week 32 and Week 36|ITT Population.||Units on a scale||Standard Error|Least Squares Mean
687097|NCT01480596|Secondary|Mean Change From Baseline in the Myasthenia Gravis Activities of Daily Living Scale (MG-ADL) at Week 12 and Week 24|The total MG-ADL score was calculated by adding the score of each of the 8 individual MG-ADL questions. Possible total MG-ADL scores ranges from 0 (normal) to 24 (severe). A lower score indicates a better clinical outcome. Baseline is defined as the participants last available assessment prior to initiation of study IV infusion. Change from Baseline was calculated by subtracting the Baseline value from the post-baseline value. The differences in adjusted least square means are presented (Belimumab 10 mg/kg minus Placebo). A negative treatment difference indicates benefit relative to placebo. The analysis method was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline MG-ADL Score, Treatment by Visit, and Baseline MG-ADL Score by Visit. Only those participants available at the indicated time points (represented by n=X in the category titles) were analyzed.|Baseline, Week 12 and Week 24|ITT Population.||Units on a scale||Standard Error|Least Squares Mean
687098|NCT01480596|Secondary|Number of Participants With MGFA-PIS (Unchanged, Improved, Worsened) at Week 24 and Week 36|Myasthenia Foundation of America (MGFA) post intervention status (PIS) assesses whether subjects can be categorized as being unchanged, improved or worsened.|Week 24 and Week 36|The Reporting and Analysis Plan pre-specified that these analyses would not be conducted since during a review of blinded data it was identified that the MGFA scale had been inconsistently performed across sites and any statistical analyses would not be interpretable.|||||
687099|NCT01480596|Secondary|Number of Participants With MGFA-PIS of Pharmacologic Response Sustained Response (PR at Week 12 and Maintained the Response Through Week 24)|Myasthenia Foundation of America (MGFA) post intervention status (PIS) assesses whether subjects can be categorized as being in a status of Minimal Manifestation (MM), Pharmacologic Remission (PR) or Complete Remission (CR). Only MM and PR were assessed in this study as CR is not achievable based on the definition.|Week 12 through Week 24|The Reporting and Analysis Plan pre-specified that these analyses would not be conducted since during a review of blinded data it was identified that the MGFA scale had been inconsistently performed across sites and any statistical analyses would not be interpretable.|||||
687100|NCT01480596|Secondary|Number of Participants With MGFA-PIS of Minimal Manifestation Sustained Response (MM at Week 12 and Maintained the Response Through Week 24)|Myasthenia Foundation of America (MGFA) post intervention status (PIS) assesses whether subjects can be categorized as being in a status of Minimal Manifestation (MM), Pharmacologic Remission (PR) or Complete Remission (CR). Only MM and PR were assessed in this study as CR is not achievable based on the definition.|Week 12 through Week 24|The Reporting and Analysis Plan pre-specified that these analyses would not be conducted since during a review of blinded data it was identified that the MGFA scale had been inconsistently performed across sites and any statistical analyses would not be interpretable.|||||
687101|NCT01480596|Secondary|Number of Participants With MGFA-PIS of Pharmacologic Remission or Better at Week 24 and Week 36|Myasthenia Foundation of America (MGFA) post intervention status (PIS) assesses whether subjects can be categorized as being in a status of Minimal Manifestation (MM), Pharmacologic Remission (PR) or Complete Remission (CR). Only MM and PR were assessed in this study as CR is not achievable based on the definition.|Week 24 and Week 36|The Reporting and Analysis Plan pre-specified that these analyses would not be conducted since during a review of blinded data it was identified that the MGFA scale had been inconsistently performed across sites and any statistical analyses would not be interpretable.|||||
687102|NCT01480596|Secondary|Number of Participants With a Myasthenia Foundation of America-post Intervention Status (MGFA-PIS) of Minimal Manifestation or Better at Week 24 and Week 36.|Myasthenia Foundation of America-post intervention status assesses whether subjects can be categorized as being in a status of Minimal Manifestation (MM), Pharmacologic Remission (PR) or Complete Remission (CR). Only MM and PR were assessed in this study as CR is not achievable based on the definition.|Week 24 and Week 36|The Reporting and Analysis Plan pre-specified that these analyses would not be conducted since during a review of blinded data it was identified that the MGFA scale had been inconsistently performed across sites and any statistical analyses would not be interpretable.|||||
687103|NCT01480596|Secondary|Mean Change From Baseline for MGC Score at Week 28, Week 32 and Week 36|The total MGC score was calculated by adding the score of each of the 10 individual MGC questions. Possible total MGC scores range from 0 (normal) to 50 (severe). A lower score indicates a better clinical outcome. Baseline is defined as the participant's last available assessment prior to initiation of study IV infusion. Change from Baseline was calculated by subtracting the Baseline value from the post-BL value. The differences in adjusted least square means are presented (Belimumab 10 mg/kg minus Placebo). A negative treatment difference indicates benefit relative to placebo. The analysis method was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline MGC Score, Treatment by Visit, and Baseline MGC Score by Visit. Only follow-up visits are presented but the analysis also includes all treatment phase visits. Only those participants available at the indicated time points (represented by n=X in the category titles) were analyzed.|Baseline, Week 28, Week 32 and Week 36|ITT Population.||Units on a scale||Standard Error|Least Squares Mean
687104|NCT01480596|Secondary|Median Time to MGC Response Which is Sustained From Earliest Time Point at Which Improvement by >=3 Points From Baseline is Observed and Maintained Through Week 24|A sustained response during the treatment phase is when a participant improves by >=3 points from Baseline at Week 12, and the participant maintains at least a 3 point improvement from Baseline through Week 24. The total MGC score was calculated by adding the score of each of the 10 individual MGC questions. Possible total MGC scores range from 0 (normal) to 50 (severe). A lower score indicates a better clinical outcome. Baseline is defined as the participants' last available assessment prior to initiation of study intravenous (IV) infusion.|Baseline and up to Week 24|As per the criteria documented in the Reporting and Analysis Plan these analyses were not conducted since <50% of subjects met the criteria (i.e. had the event in question).|||||
687105|NCT01480596|Secondary|Number of Participants With a Sustained Response in the MGC Score|AA sustained response during the treatment phase is when a participant improves by >=3 points from Baseline at Week 12, and the participant maintains at least a 3 point improvement from Baseline through Week 24. The total MGC score was calculated by adding the score of each of the 10 individual MGC questions. Possible total MGC scores range from 0 (normal) to 50 (severe). A lower score indicates a better clinical outcome. Baseline is defined as the participants last available assessment prior to initiation of study IV infusion. Odds ratios are calculated by Cochran-Mantel-Haenszel method without adjusting for any strata. Wald confidence intervals and p-values were presented.|Baseline and up to Week 24|ITT Population.||Number of participants|||Number
687106|NCT01480596|Secondary|Number of Participants Worsening by >=3 Points From Baseline Through to Week 24 in the MGC Score|The total MGC score was calculated by adding the score of each of the 10 individual MGC questions. Possible total MGC scores range from 0 (normal) to 50 (severe). A lower score indicates a better clinical outcome. Baseline is defined as the participants last available assessment prior to initiation of study IV infusion. Proportions compared using exact analyses stratified by the observed median baseline score (<= median, > median). Exact odds ratios, double the exact one-sided p-values and exact confidence intervals were presented. Participants with missing data were assumed to have a worsening response.|Baseline and up to Week 24|ITT Population.||Number of participants|||Number
687107|NCT01480596|Secondary|Number of Participants With Improvement by >=3 Points From Baseline Through to Week 24 in the MGC Score|The total MGC score was calculated by adding the score of each of the 10 individual MGC questions. Possible total MGC scores range from 0 (normal) to 50 (severe). A lower score indicates a better clinical outcome. Baseline is defined as the participants last available assessment prior to initiation of study IV infusion. Proportions compared using exact analyses stratified by the observed median baseline score (<= median, > median). Exact odds ratios, double the exact one-sided p-values and exact confidence intervals were presented. Participants with missing data were assumed to have a negative response.|Baseline and up to Week 24|ITT Population.||Number of participants|||Number
687108|NCT01480596|Secondary|Mean Change From Baseline in Myasthenia Gravis Composite (MGC) Scale Through to Week 24|The total MGC score was calculated by adding the score of each of the 10 individual MGC questions. Possible total MGC scores range from 0 (normal) to 50 (severe). A lower score indicates a better clinical outcome. Baseline is defined as the participants last available assessment prior to initiation of study IV infusion. Change from Baseline was calculated by subtracting the Baseline value from the post-baseline value. The differences in adjusted least square means are presented (Belimumab 10 mg/kg minus Placebo). A negative treatment difference indicates benefit relative to placebo. The analysis method was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline MGC Score, Treatment by Visit, and Baseline MGC Score by Visit.|Baseline and up to Week 24|ITT Population.||Units on a scale||Standard Error|Least Squares Mean
687109|NCT01480596|Secondary|Mean Change From Baseline for QMG Score at Week 28, Week 32 and Week 36|The QMG is a 13 item ordinal scale which measures ocular, bulbar, extremity fatigue and strength, along with respiratory function. Total QMG score was calculated by adding the score of each of the 13 individual QMG questions. Possible scoring on the QMG range from 0 (mild) to 39 (severe). A lower score indicates a better clinical outcome. The QMG score at baseline (BL) is the average of the screening and Week 0 BL scores. Change from BL was calculated by subtracting the BL value from the post-BL value. The differences in adjusted least square means are presented (Belimumab 10 mg/kg minus Placebo). A negative trt difference indicates benefit relative to placebo. Analysis method was Mixed-Model Repeated Measures adjusted for Trt, Visit, BL QMG Score, Trt by Visit and BL QMG Score by Visit. Only follow-up visits are presented but the analysis also includes all trt phase visits. Only those par. available at indicated time points (represented by n=X in the category titles) were analyzed.|Baseline, Week 28, Week 32 and Week 36|ITT Population.||Units on a scale||Standard Error|Least Squares Mean
687110|NCT01480596|Secondary|Median Time to QMG Response Which is Sustained From Earliest Time Point at Which Improvement by >=3 Points From Baseline is Observed and Maintained Through Week 24|A sustained response during the treatment phase is when a participant improves by >=3 points from Baseline at Week 12, and the participant maintains at least a 3 point improvement from Baseline through Week 24. The QMG is a 13 item ordinal scale which measures ocular, bulbar, extremity fatigue and strength, along with respiratory function. The total QMG score was calculated by adding the score of each of the 13 individual QMG questions. Possible scoring on the QMG range from 0 (normal) to 39 (severe). A lower score indicates a better clinical outcome. The QMG score at Baseline is the average of the screening and Week 0 Baseline scores.|Baseline and up to Week 24|As per the criteria documented in the Reporting and Analysis Plan these analyses were not conducted since <50% of subjects met the criteria (i.e. had the event in question).|||||
687111|NCT01480596|Secondary|Number of Participants With a Sustained Response in the QMG Score|A sustained response during the treatment phase is when a participant improves by >=3 points from Baseline at Week 12, and the participant maintains at least a 3 point improvement from Baseline through Week 24. The QMG is a 13 item ordinal scale which measures ocular, bulbar, extremity fatigue and strength, along with respiratory function. The total QMG score was calculated by adding the score of each of the 13 individual QMG questions. Possible scoring on the QMG range from 0 (normal) to 39 (severe). A lower score indicates a better clinical outcome. The QMG score at Baseline is the average of the screening and Week 0 Baseline scores. Odds ratios are calculated by Cochran-Mantel-Haenszel method stratified by the observed median baseline score (<= median, > median). Wald confidence intervals and p-values were presented.|Baseline and up to Week 24|ITT Population.||Number of participants|||Number
687112|NCT01480596|Secondary|Number of Participants Worsening by >=3 Points in QMG Score From Baseline Through to Week 24|The QMG is a 13 item ordinal scale which measures ocular, bulbar, extremity fatigue and strength, along with respiratory function. The total QMG score was calculated by adding the score of each of the 13 individual QMG questions. Possible scoring on the QMG range from 0 (normal) to 39 (severe). A lower score indicates a better clinical outcome. The QMG score at Baseline is the average of the screening and Week 0 Baseline scores. Proportions compared using exact analyses stratified by the observed median Baseline score (<=median, > median). Exact odds ratio, double the exact one-sided p-value and exact confidence interval were presented. Participants with missing data were assumed to have a worsening response.|Baseline and up to Week 24|ITT Population.||Number of participants|||Number
687113|NCT01480596|Secondary|Number of Participants With Improvement by Greater Than or Equal to (>=) 3 Points From Baseline Through to Week 24 in the QMG Score|The QMG is a 13 item ordinal scale which measures ocular, bulbar, extremity fatigue and strength, along with respiratory function. The total QMG score was calculated by adding the score of each of the 13 individual QMG questions. Possible scoring on the QMG range from 0 (normal) to 39 (severe). A lower score indicates a better clinical outcome. The QMG score at Baseline is the average of the screening and Week 0 Baseline scores. Proportions compared using exact analyses stratified by the observed median Baseline score (less than or equal to [<=] median, greater than [ >] median). Exact odds ratio, double the exact one-sided p-value and exact confidence intervals were presented. Participants with missing data were assumed to have a negative response.|Baseline and up to Week 24|ITT Population.||Number of participants|||Number
687114|NCT01480596|Primary|Mean Change From Baseline for Quantitative Myasthenia Gravis (QMG) Score at Week 24|The QMG is a 13 item ordinal scale which measures ocular, bulbar, extremity fatigue and strength, along with respiratory function. The total QMG score was calculated by adding the score of each of the 13 individual QMG questions. Possible scoring on the QMG range from 0 (normal) to 39 (severe). A lower score indicates a better clinical outcome. The QMG score at Baseline is the average of the screening and Week 0 Baseline scores. Change from Baseline was calculated by subtracting the Baseline value from the post-baseline value. The differences in adjusted least square means were presented (Belimumab 10 mg/kg minus Placebo). A negative treatment difference indicates benefit relative to placebo. The analysis method was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline QMG Score, Treatment by Visit, and Baseline QMG Score by Visit.|Baseline and Week 24|Intent-to-Treat (ITT) Population includes participants in the Safety Population who has provided any post treatment efficacy assessment.||Units on a scale||Standard Error|Least Squares Mean
687115|NCT01480297|Primary|Intra-epidermal Nerve Fiber Density (IENFD) Fibers Per mm|Intra-epidermal Nerve Fiber Density (IENFD) was measured at two anatomic locations (thigh and ankle) at baseline and after 12 weeks of treatment with Salsalate. IENFD is expressed as fibers per mm. Means and standard deviations are shown.|Baseline and 12 weeks|Type 1 diabetes with painful neuropathy||fibers per mm||Standard Deviation|Mean
687116|NCT01480284|Secondary|Number of Participants With Resistance Related Mutations at Week 24, Week 48, Week 96 and Virological Breakthrough (Baseline to Throughout the Study)|"The development of drug resistance-related (RA) mutations was analyzed to look for resistance to Lamivudine (LAM), Adefovir dipivoxil (ADV), and/or ETV in a case where a virologic breakthrough has been observed after starting the study treatment (serum HBV DNA level has increased from the nadir by at least 1 log10 copies/mL) or where the serum HBV DNA level is not less than the HBV DNA detection limit (2.1 log10 copies/mL) at Week 24, Week 48 and Week 96. Virologic breakthrough was defined as 1.0 log10 or greater increases in serum HBV-DNA levels from on-treatment nadir. Participants who achieved the HBV-DNA values below lower limit of quantification (LLQ) (< 2.1 log10 copies/mL) in quantitative analysis at entire the study were also considered Negative in drug-resistance without implementation of genotypic analysis. Resistance mutation values were presented from Baseline to throughout the study. Baseline is defined as the value at Week 0 visit."|Screening, Week 24, Week 48, Week 96 and Virological Breakthrough (Baseline to throughout the study)|FAS Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).||Participants|||Number
687117|NCT01480284|Secondary|Number of Participants With Virological Breakthrough Through End of the Study|The number of participants who experienced virological breakthrough was summarized. Virological breakthrough is defined as serum HBV DNA level increase >=1 log10 copies/mL above the treatment nadir. Virological breakthrough values were presented from Baseline to through out the study. Baseline is defined as the value at Week 0 visit.|From Baseline to throughout study|FAS Population||Participants|||Number
687118|NCT01480284|Secondary|Number of Participants Achieving Each Indicated HBcrAg Category at Baseline, Week 24, Week 48 and Week 96|The number of participants achieving each indicated hepatitis B core-related antigen (HBcrAg) category (HBcrAg <3.0, 3.0 to 4.0, 4.0 to 5.0, 5.0 to 6.0, and >=6.0) (Log kilo unit per liter [KU/L]) by study visit was summarized. The LOCF method was applied for missing values.|Baseline, Week 24, Week 48 and Week 96|FAS Population||Participants|||Number
687119|NCT01480284|Secondary|Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96|The number of participants achieving each indicated HBsAg category (HBsAg <80, 80 to 800, 800 to 8000, 8000 to 80000, and >=80000) (kilo international unit per liter [KIU/L]) by study visit was summarized. The LOCF method was applied for missing values.|Baseline, Week 24, Week 48 and Week 96|FAS Population||Participants|||Number
687120|NCT01480284|Secondary|Number of Participants Achieving HBsAg/HBsAb Seroconversion at Week 24, Week 48 and Week 96|The number of participants with HBsAg/hepatitis B surface antibody (HBsAb) seroconversion at Week 24, Week 48 and Week 96 in positive HBsAg and negative HBsAb participants at Baseline were summarized. HBsAg seroconversion .is defined as change of detectable antibody to HBsAg from negative to positive. The LOCF method was applied for missing values.|Week 24, Week 48 and Week 96|FAS Population. Only participants with positive HBsAg and negative HBsAb at Baseline were analyzed.||Participants|||Number
687121|NCT01480284|Secondary|Number of Participants Achieving HBsAg Loss at Week 24, Week 48 and Week 96|The number of participants with hepatitis B surface antigen (HBsAg) loss at Week 24, Week 48 and Week 96 in positive HBsAg participants at Baseline were summarized. Loss of HBsAg is defined as change of detectable HBsAg from positive to negative. The LOCF method was applied for missing values.|Week 24, Week 48 and Week 96|FAS Population.||Participants|||Number
687122|NCT01480284|Secondary|Number of Participants With HBeAg/HBeAb Seroconversion at Week 24, Week 48 and Week 96|The number of participants achieving HBeAg/hepatitis Be antibody (HBeAb) seroconversion at Week 24, Week 48 and Week 96 in positive HBeAg and negative HBeAb participants at Baseline were summarized. Seroconversion to HBeAg is defined as the change of detectable antibody to HBeAg from negative to positive. The LOCF method was applied for missing values.|Week 24, Week 48 and Week 96|FAS Population. Only participants with positive HBeAg and negative HBeAb at Baseline were analyzed.||Participants|||Number
687123|NCT01480284|Secondary|Number of Participants With HBeAg Loss at Week 24, Week 48 and Week 96|The number of participants achieving hepatitis Be antigen (HBeAg) loss at Week 24, Week 48 and Week 96 in positive HBeAg participants at Baseline were summarized. Loss of HBeAg is defined as the change of detectable HBeAg from positive to negative. The LOCF method was applied for missing values.|Week 24, Week 48 and Week 96|FAS Population. Only participants with positive HBeAg at Baseline were analyzed.||Participants|||Number
687124|NCT01480284|Secondary|Number of Participants With Alanine Aminotransferase (ALT) Normalization at Week 24, Week 48 and Week 96|The number of participants with alanine aminotransferase (ALT) normalization at Week 24, Week 48 and Week 96 were summarized. ALT normalization is defined as when an ALT value exceeds the upper limit of normal range (ULN) at Baseline and within the normal range at the end of treatment. The LOCF method was applied for missing values.|Week 24, Week 48 and Week 96|Biochemically Evaluable Population (BEP): all participants who received at least one dose of IP and with an abnormal ALT at Baseline. The population for the analysis of ALT normalization was all participants with an ALT value > ULN at Baseline.||Participants|||Number
687126|NCT01480284|Secondary|Mean Change From Baseline in Serum HBV DNA Level at Week 48 and Week 96|The mean change from Baseline in the HBV DNA level at Week 48 and Week 96 were assessed (lower limit of quantitation : 2.1 log10 copies/mL). The mean values were adjusted by Baseline HBV DNA levels. Change from Baseline was calculated as the post-baseline value minus the Baseline value. The LOCF method was applied for missing values.|Baseline, Week 48 and Week 96|Full Analysis Set (FAS) Population: all participants who entered into the study, received at least one dose of investigational product, and have at least one efficacy assessment after the treatment initiation.||log10 copies/mL||Standard Deviation|Mean
687127|NCT01480284|Primary|Mean Change From Baseline in Serum HBV DNA Level at Week 24|The mean change from Baseline in the hepatitis B virus deoxyribonucleic acid (HBV DNA) level at Week 24 was assessed (lower limit of quantitation : 2.1 log 10 copies/mL). The mean values were adjusted by Baseline HBV DNA levels. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Week 24|Per Protocol Set (PPS) Population: all participants who received at least 1 dose of investigational product (IP) and had at least one efficacy assessment after the treatment initiation, and with no major protocol violations. Missing values observed during the treatment period were imputed by the last observation carried forward (LOCF) method.||log10 copies/milliliter (copies/mL)||Standard Error|Least Squares Mean
687128|NCT01480232|Secondary|Effects of EVP-6124 on Working Memory as Measured by the N-Back Task Reaction Time|This task is a standard measure that can assess working memory performance under varying levels of task demand. Subjects are presented with a stream of stimuli, and the task is to decide for each stimulus whether it matches the one presented N items before. The processing load can be varied systematically by manipulating the value of N, which is expressed with changes in accuracy and reaction time. The number of errors as well as reaction times increase monotonically with increasing levels of N. The n-back task is sensitive to nicotine administration and abstinence effects. Here we present reaction time (RT)|Baseline, week 1, week 12|||mili seconds||Standard Deviation|Mean
687129|NCT01480232|Secondary|Safety and Tolerability of EVP-6124 Alone or Combined With NRT|All AEs (adverse experiences) spontaneously reported by subjects and/or observed by investigator and evaluation of physical examinations, prior and concomitant medications, clinical laboratory tests, ECGs, and vital signs measurements. Data was collected at every visit and was analyzed as aggregate at the end of week 12|Weeks 1-12|||Participants|||Count of Participants
687130|NCT01480232|Secondary|Effects of EVP-6124 on Cognitive Performance as Measured by the Continuous Performance Test Hit Reaction Time|The Continuous Performance Test (CPT) is a measure of both vigilance/attentional control and response inhibition. During the task, subjects are required to press a button whenever a letter appears on the screen unless that letter is an ‘X’. Measures of attentional control will serve as primary measure from this test. Baseline attentional impairment is associated with reduced odds of abstinence, abstinence differentially worsens performance on this measure in those with baseline attentional impairment, and NRT improves performance on a similar measure.|Baseline, week 1, week 12|||mili seconds||Standard Deviation|Mean
687131|NCT01480232|Primary|Difference in Expired Carbon Monoxide (CO) Concentration From Baseline to End Point|CO concentration was measured at every visit.|Baseline, Weeks 1, 2, 4, 6, 8, 10, 12|||part per million||Standard Deviation|Mean
687132|NCT01480232|Primary|Effects of EVP-6124 on 7-day Point-prevalence Smoking Abstinence|Smoking abstinence is defined as a self-report of smoking no cigarettes for the past 7 days by time-line follow-back, confirmed by expired carbon monoxide (CO) <10 ppm and/or urine cotinine <50 ng/mL.|Week 1, 2, 4, 6, 8, 10, 12|The primary smoking cessation variable is biochemically verified self-report of 7-day point prevalence abstinence at 12 weeks (end of treatment).||% participants with 7-Day Point Prevalen|||Number
687133|NCT01480219|Primary|Number of Participants Who Developed Non-Melanoma Skin Cancer (NMSC)||Baseline until non-melanoma skin cancer diagnosis, loss-to-follow-up due to death or termination of the health plan or end of the study, assessed up to Year 8|Final analysis set included participants who met the eligibility criteria.||participants|||Number
687134|NCT01480089|Secondary|Post-op Pain With Atomized Intraperitoneal Ropivacaine (AIR)|Participants are asked to rate their pain level using the visual analog scale (VAS). The VAS is a measurement of pain where respondents specify their level of pain by indicating a position along a continuous line between two end-points. The VAS used in this study was a horizontal line of 100 mm length anchored by two word descriptors - one word at each end: No pain (left end) and Very Severe Pain (right end). The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks. The VAS range is 0 to 100.|12 hours after surgery|All individuals randomized are included in this analysis.||millimeters||Standard Deviation|Mean
687135|NCT01480089|Primary|Post-op Pain With Atomized Intraperitoneal Ropivacaine (AIR)|Participants are asked to rate their pain level using the visual analog scale (VAS). The VAS is a measurement of pain where respondents specify their level of pain by indicating a position along a continuous line between two end-points. The VAS used in this study was a horizontal line of 100 mm length anchored by two word descriptors - one word at each end: No pain (left end) and Very Severe Pain (right end). The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks. The VAS range is 0 to 100.|2 hours after surgery|All individuals randomized are included in this analysis.||millimeters||Standard Deviation|Mean
687136|NCT01480076|Secondary|Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)|AE: any untoward medical occurrence that did not necessarily have a causal relationship with study treatment. SAE: any untoward medical occurrence that at any dose: resulted in death; in the view of the Investigator, placed the subject at immediate risk of death (a life threatening event); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigator, could have jeopardized the subject or may have required intervention to prevent one of the other outcomes listed in the definition above.|From signing of Informed Consent (SAEs) or from first dose of study treatment (AEs) through Week 50 or Early Termination (14 +/- 7 days after last dose)|Intent-to-treat population: all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit.||participants|||Number
687137|NCT01480076|Secondary|Change From Baseline in Regular Activity Productivity Loss on the WPAI-SHP Questionnaire at Months 3, 6, 9, and 12 by Whether Taking Additional MS Therapy|WPAI-SHP is a 6-question participant-rated questionnaire to determine degree to which a specific health problem affected work productivity while at work and outside of work. Four scores are derived: percentage of absenteeism (percentage of work time missed) and presenteeism (reduced productivity while at work), overall work impairment score combining absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. Score range: 0 (not affected/no impairment) to 100 (completely affected/impaired). WPAI outcomes are expressed as impairment percentages with higher numbers indicating greater impairment and less productivity. A decrease from Baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, and 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.||percentage of activity impairment||Standard Error|Least Squares Mean
687138|NCT01480076|Secondary|Change From Baseline in Percent Overall Work Impairment Due to MS on the WPAI-SHP Questionnaire at Months 3, 6, 9, and 12 by Whether Taking Additional MS Therapy|WPAI-SHP is a 6-question participant-rated questionnaire to determine degree to which a specific health problem affected work productivity while at work and outside of work. Four scores are derived: percentage of absenteeism (percentage of work time missed) and presenteeism (reduced productivity while at work), overall work impairment score combining absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. Score range: 0 (not affected/no impairment) to 100 (completely affected/impaired). WPAI outcomes are expressed as impairment percentages with higher numbers indicating greater impairment and less productivity. A decrease from Baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, and 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.||percentage of overall work impairment||Standard Error|Least Squares Mean
687139|NCT01480076|Secondary|Change From Baseline in Percent Impairment While Working Due to MS on the WPAI-SHP Questionnaire at Months 3, 6, 9, and 12 by Whether Taking Additional MS Therapy|WPAI-SHP is a 6-question participant-rated questionnaire to determine degree to which a specific health problem affected work productivity while at work and outside of work. Four scores are derived: percentage of absenteeism (percentage of work time missed) and presenteeism (reduced productivity while at work), overall work impairment score combining absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. Score range: 0 (not affected/no impairment) to 100 (completely affected/impaired). WPAI outcomes are expressed as impairment percentages with higher numbers indicating greater impairment and less productivity. A decrease from Baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, and 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.||percentage of impairment while working||Standard Error|Least Squares Mean
687140|NCT01480076|Secondary|Change From Baseline in Percent Work Time Missed Due to MS on the WPAI-SHP Questionnaire at Months 3, 6, 9, and 12 by Whether Taking Additional MS Therapy|WPAI-SHP is a 6-question participant-rated questionnaire to determine degree to which a specific health problem affected work productivity while at work and outside of work. Four scores are derived: percentage of absenteeism (percentage of work time missed) and presenteeism (reduced productivity while at work), overall work impairment score combining absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. Score range: 0 (not affected/no impairment) to 100 (completely affected/impaired). WPAI outcomes are expressed as impairment percentages with higher numbers indicating greater impairment and less productivity. A decrease from Baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, and 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.||percentage of work time missed||Standard Error|Least Squares Mean
687141|NCT01480076|Secondary|Change From Baseline in the Index Scores of EQ-5D at Months 3, 6, 9, and 12 by Whether Taking Additional MS Therapy|EQ-5D is a participant-answered questionnaire containing a descriptive system on 5 dimensions - mobility, self-care, usual activities, pain/discomfort and anxiety/depression and a VAS on health state. The scores on the 5 dimensions of descriptive system can be converted into an index score by applying UK weights. EQ-5D index score ranges from 1 to -0.59, and 1 reflects the best outcome. An increase from baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.||units on a scale||Standard Error|Least Squares Mean
687182|NCT01479868|Primary|Percentage of Participants With Sustained Virologic Response at Week 12 (SVR 12)|The SVR 12 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) levels less than (<) 25 international unit per milliliter (IU/mL) undetectable at the actual end of treatment (EOT), and HCV RNA levels <25 IU/mL undetectable or HCV RNA levels <25 IU/mL detectable at 12 Weeks after end of treatment.|12 weeks after end of treatment (Week 24 or 48)|Intent to treat (ITT) population included all participants who received at least 1 dose of study drug.||percentage of participants|||Number
687142|NCT01480076|Secondary|Change From Baseline in the Current Health State of EQ-5D VAS at Months 3, 6, 9, and 12 by Whether Taking Additional MS Therapy|EQ-5D is a participant-answered questionnaire containing a descriptive system of 5 dimensions - mobility, self-care, usual activities, pain/discomfort and anxiety/depression and a VAS on health state. The EQ-5D VAS ranges from 0 (worst health state) to 100 (best health state). An increase from baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.||units on a scale||Standard Error|Least Squares Mean
687143|NCT01480076|Secondary|Change From Baseline in the Activities Limitation Scale of the PRIMUS at Months 3, 6, 9, and 12 by Whether Taking Additional MS Therapy|The PRIMUS activity measure is a 15-item assessment of patient-reported activities of daily living. The total score was calculated as sum of all 15 items converted into a 0-30 range, where missing items were imputed by average of non-missing total when no more than 50% of items were missing (otherwise, the total score is missing). Higher score indicates worse condition. A decrease from Baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.||units on a scale||Standard Error|Least Squares Mean
687144|NCT01480076|Secondary|Change From Baseline in MSIS-29 Psychological Score at Months 3, 6, 9, and 12 by Whether Taking Additional MS Therapy|The MSIS-29 is a disease-specific patient-reported outcome measure that has been developed and validated to examine the physical and psychological impact of MS from a patient's perspective; it measures 20 physical items and 9 psychological items. Sum of 9 psychological condition items converted into a 0-100 score range, where missing items are imputed by average of total of non-missing items when no more than 50% are missing (otherwise the total score is missing). A lower total score indicates less psychologically-related impact while a higher total score indicates greater psychologically-related impact on a participant's functioning. Decreases from Baseline indicate improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Months 3, 6, 9, and 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.||units on a scale||Standard Error|Least Squares Mean
687145|NCT01480076|Secondary|Change From Baseline in the MSIS-29 Physical Score at Months 3, 6, 9, and 12 by Whether Taking Additional MS Therapy|The MSIS-29 is a disease specific patient-reported outcome measure that has been developed and validated to examine the physical and psychological impact of MS from a patient’s perspective; it measures 20 physical items and 9 psychological items. Sum of 20 physical condition items converted into a 0-100 score range, where missing items are imputed by average of total of non-missing items when no more than 50% are missing (otherwise the total score is missing). A lower total score indicates less physically-related impact while a higher total score indicates greater physically-related impact on a participant's functioning. Decreases from Baseline indicate improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, and 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.||units on a scale||Standard Error|Least Squares Mean
687146|NCT01480076|Secondary|Change From Baseline in the MCS of the SF-36 at Months 3, 6, 9, and 12 by Whether Taking Additional MS Therapy|The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. Scores on each item are summed and averaged (range: 0=worst to 100=best). Increases from baseline indicate improvement. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.||units on a scale||Standard Error|Least Squares Mean
687147|NCT01480076|Secondary|Change From Baseline in the PCS of the SF-36 at Months 3, 6, 9, and 12 by Whether Taking Additional MS Therapy|The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. Scores on each item are summed and averaged (range: 0=worst to 100=best). Increases from baseline indicate improvement. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.||units on a scale||Standard Error|Least Squares Mean
687183|NCT01479777|Secondary|Change in Peak Cough Flow|Change in cough flow following 8 weeks of FES. Change in peak cough flow from baseline was computed from week 8 parameters.|Baseline, 8 weeks|||liters/minute||Full Range|Mean
687148|NCT01480076|Secondary|Change From Baseline in Regular Activity Productivity Loss on the WPAI-SHP Questionnaire at Months 3, 6, 9, and 12 by MS Disease Type: Responders|WPAI-SHP is a 6-question participant-rated questionnaire to determine degree to which a specific health problem affected work productivity while at work and outside of work. Four scores are derived: percentage of absenteeism (percentage of work time missed) and presenteeism (reduced productivity while at work), overall work impairment score combining absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. Score range: 0 (not affected/no impairment) to 100 (completely affected/impaired). WPAI outcomes are expressed as impairment percentages with higher numbers indicating greater impairment and less productivity. A decrease from Baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, and 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.||percentage of activity impairment||Standard Error|Least Squares Mean
687149|NCT01480076|Secondary|Change From Baseline in Percent Overall Work Impairment Due to MS on the WPAI-SHP Questionnaire at Months 3, 6, 9, and 12 by MS Disease Type: Responders|WPAI-SHP is a 6-question participant-rated questionnaire to determine degree to which a specific health problem affected work productivity while at work and outside of work. Four scores are derived: percentage of absenteeism (percentage of work time missed) and presenteeism (reduced productivity while at work), overall work impairment score combining absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. Score range: 0 (not affected/no impairment) to 100 (completely affected/impaired). WPAI outcomes are expressed as impairment percentages with higher numbers indicating greater impairment and less productivity. A decrease from Baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, and 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.||percentage of overall work impairment||Standard Error|Least Squares Mean
687150|NCT01480076|Secondary|Change From Baseline in Percent Impairment While Working Due to MS on the WPAI-SHP Questionnaire at Months 3, 6, 9, and 12 by MS Disease Type: Responders|WPAI-SHP is a 6-question participant-rated questionnaire to determine degree to which a specific health problem affected work productivity while at work and outside of work. Four scores are derived: percentage of absenteeism (percentage of work time missed) and presenteeism (reduced productivity while at work), overall work impairment score combining absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. Score range: 0 (not affected/no impairment) to 100 (completely affected/impaired). WPAI outcomes are expressed as impairment percentages with higher numbers indicating greater impairment and less productivity. A decrease from Baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, and 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.||percentage of impairment while working||Standard Error|Least Squares Mean
687151|NCT01480076|Secondary|Change From Baseline in Percent Work Time Missed Due to MS on the WPAI-SHP Questionnaire at Months 3, 6, 9, and 12 by MS Disease Type: Responders|WPAI-SHP is a 6-question participant-rated questionnaire to determine degree to which a specific health problem affected work productivity while at work and outside of work. Four scores are derived: percentage of absenteeism (percentage of work time missed) and presenteeism (reduced productivity while at work), overall work impairment score combining absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. Score range: 0 (not affected/no impairment) to 100 (completely affected/impaired). WPAI outcomes are expressed as impairment percentages with higher numbers indicating greater impairment and less productivity. A decrease from Baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, and 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.||percentage of work time missed||Standard Error|Least Squares Mean
687152|NCT01480076|Secondary|Change From Baseline in EQ-5D Index Scores at Months 3, 6, 9, and 12 by MS Disease Type: Responders|EQ-5D is a participant-answered questionnaire containing a descriptive system on 5 dimensions - mobility, self-care, usual activities, pain/discomfort and anxiety/depression and a VAS on health state. The scores on the 5 dimensions of descriptive system can be converted into an index score by applying UK weights. EQ-5D index score ranges from 1 to -0.59, and 1 reflects the best outcome. An increase from baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, and 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.||units on a scale||Standard Error|Least Squares Mean
687184|NCT01479777|Secondary|Change in Vital Capacity|Change in vital capacity following 8 weeks of FES. Change in vital capacity from baseline was computed from week 8 parameters.|Baseline, 8 weeks|||litres||Full Range|Mean
687185|NCT01479777|Secondary|Change in Rate of Perceived Exertion|"Change in rate of perceived exertion (RPE) following 8 weeks of FES. Change in rate of perceived exertion (RPE) from baseline was computed from week 8 parameters.
The RPE scale is a 15 point scale ranging from 6 to 20 points. Higher scores indicate greater exertion."|Baseline, 8 weeks|||scores on RPE scale||Full Range|Mean
687153|NCT01480076|Secondary|Change From Baseline in Current Health State of the EQ-5D VAS at Months 3, 6, 9, and 12 by MS Disease Type: Responders|EQ-5D is a participant-answered questionnaire containing a descriptive system of 5 dimensions - mobility, self-care, usual activities, pain/discomfort and anxiety/depression and a VAS on health state. The EQ-5D VAS ranges from 0 (worst health state) to 100 (best health state). An increase from baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, and 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.||units on a scale||Standard Error|Least Squares Mean
687154|NCT01480076|Secondary|Change From Baseline in the Activity Limitation Scale (ALS) of PRIMUS Score at Months 3, 6, 9, and 12 by MS Disease Type: Responders|The PRIMUS activity measure is a 15-item assessment of patient-reported activities of daily living. The total score was calculated as sum of all 15 items converted into a 0-30 range, where missing items were imputed by average of non-missing total when no more than 50% of items were missing (otherwise, the total score is missing). Higher score indicates worse condition. A decrease from Baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, and 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.||units on a scale||Standard Error|Least Squares Mean
687155|NCT01480076|Secondary|Change From Baseline in the MSIS-29 Psychological Score at Months 3, 6, 9, and 12 by MS Disease Type: Responders|The MSIS-29 is a disease-specific patient-reported outcome measure that has been developed and validated to examine the physical and psychological impact of MS from a patient's perspective; it measures 20 physical items and 9 psychological items. Sum of 9 psychological condition items converted into a 0-100 score range, where missing items are imputed by average of total of non-missing items when no more than 50% are missing (otherwise the total score is missing). A lower total score indicates less psychologically-related impact while a higher total score indicates greater psychologically-related impact on a participant's functioning. Decreases from Baseline indicate improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, and 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.||units on a scale||Standard Error|Least Squares Mean
687156|NCT01480076|Secondary|Change From Baseline in the MSIS-29 Physical Score at Months 3, 6, 9, and 12 by MS Disease Type: Responders|The MSIS-29 is a disease-specific patient-reported outcome measure that has been developed and validated to examine the physical and psychological impact of MS from a patient’s perspective; it measures 20 physical items and 9 psychological items. Sum of 20 physical condition items converted into a 0-100 score range, where missing items are imputed by average of total of non-missing items when no more than 50% are missing (otherwise the total score is missing). A lower total score indicates less physically-related impact while a higher total score indicates greater physically-related impact on a participant's functioning. Decreases from Baseline indicate improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, and 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.||units on a scale||Standard Error|Least Squares Mean
687157|NCT01480076|Secondary|Change From Baseline in the MCS of the SF-36 at Months 3, 6, 9, and 12 by MS Disease Type: Responders|The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. Scores on each item are summed and averaged (range: 0=worst to 100=best). Increases from baseline indicate improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, and 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.||units on a scale||Standard Error|Least Squares Mean
687158|NCT01480076|Secondary|Change From Baseline in the PCS of the SF-36 at Months 3, 6, 9, and 12 by MS Disease Type: Responders|The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. Scores on each item are summed and averaged (range: 0=worst to 100=best). Increases from baseline indicate improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, and 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.||units on a scale||Standard Error|Least Squares Mean
687159|NCT01480076|Secondary|Change From Baseline in Regular Activity Productivity Loss, by the WPAI-SHP Questionnaire at Months 3, 6, 9, and 12|WPAI-SHP is a 6-question participant-rated questionnaire to determine degree to which a specific health problem affected work productivity while at work and outside of work. Four scores are derived: percentage of absenteeism (percentage of work time missed) and presenteeism (reduced productivity while at work), overall work impairment score combining absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. Score range: 0 (not affected/no impairment) to 100 (completely affected/impaired). WPAI outcomes are expressed as impairment percentages with higher numbers indicating greater impairment and less productivity. A decrease from Baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.||percentage of activity impairment||Standard Error|Least Squares Mean
687160|NCT01480076|Secondary|Change From Baseline in Percent Overall Work Impairment Due to MS, by the WPAI-SHP Questionnaire at Months 3, 6, 9, and 12|WPAI-SHP is a 6-question participant-rated questionnaire to determine degree to which a specific health problem affected work productivity while at work and outside of work. Four scores are derived: percentage of absenteeism (percentage of work time missed) and presenteeism (reduced productivity while at work), overall work impairment score combining absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. Score range: 0 (not affected/no impairment) to 100 (completely affected/impaired). WPAI outcomes are expressed as impairment percentages with higher numbers indicating greater impairment and less productivity. A decrease from Baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.||percentage of overall work impairment||Standard Error|Least Squares Mean
687161|NCT01480076|Secondary|Change From Baseline in Percent Impairment While Working Due to MS, by the WPAI-SHP Questionnaire at Months 3, 6, 9, and 12|WPAI-SHP is a 6-question participant-rated questionnaire to determine degree to which a specific health problem affected work productivity while at work and outside of work. Four scores are derived: percentage of absenteeism (percentage of work time missed) and presenteeism (reduced productivity while at work), overall work impairment score combining absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. Score range: 0 (not affected/no impairment) to 100 (completely affected/impaired). WPAI outcomes are expressed as impairment percentages with higher numbers indicating greater impairment and less productivity. A decrease from Baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.||percentage of impairment while working||Standard Error|Least Squares Mean
687162|NCT01480076|Secondary|Change From Baseline in Percent Work Time Missed Due to MS, by the Work Productivity and Activity Impairment-Specific Health Problem (WPAI-SHP) Questionnaire at Months 3, 6, 9, and 12|WPAI-SHP is a 6-question participant-rated questionnaire to determine degree to which a specific health problem affected work productivity while at work and outside of work. Four scores are derived: percentage of absenteeism (percentage of work time missed) and presenteeism (reduced productivity while at work), overall work impairment score combining absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. Score range: 0 (not affected/no impairment) to 100 (completely affected/impaired). WPAI outcomes are expressed as impairment percentages with higher numbers indicating greater impairment and less productivity. A decrease from Baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.||percentage of work time missed||Standard Error|Least Squares Mean
687163|NCT01480076|Secondary|Change From Baseline in the Index Scores of EQ-5D at Months 3, 6, 9, and 12|EQ-5D is a participant-answered questionnaire containing a descriptive system on 5 dimensions - mobility, self-care, usual activities, pain/discomfort and anxiety/depression and a VAS on health state. The scores on the 5 dimensions of descriptive system can be converted into an index score by applying United Kingdom (UK) weights. EQ-5D index score ranges from 1 to -0.59, and 1 reflects the best outcome. An increase from baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.||units on a scale||Standard Error|Least Squares Mean
687186|NCT01479777|Secondary|Change in Diastolic Plood Pressure|Change in distolic blood pressure following 8 weeks. Change in diastolic blood pressure from baseline was computed from week 8 parameters.|Baseline, 8 weeks|||mmHg||Full Range|Mean
687187|NCT01479777|Secondary|Change in Systolic Blood Pressure|Change in systolic blood pressure following 8 weeks. Change in systolic blood pressure from baseline was computed from week 8 parameters.|Baseline, 8 weeks|||mmHg||Full Range|Mean
687188|NCT01479777|Secondary|Change in Heart Rate|Change in heart rate following 8 weeks of FES. Change in heart rate from baseline was computed from week 8 parameters.|Baseline, 8 weeks|||beats per minute||Full Range|Mean
687164|NCT01480076|Secondary|Change From Baseline in the Current Health State of EuroQoL Descriptive System of Health-related Quality of Life States Consisting of 5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Months 3, 6, 9, And 12|EQ-5D is a participant-answered questionnaire containing a descriptive system of 5 dimensions - mobility, self-care, usual activities, pain/discomfort and anxiety/depression and a VAS on health state. The EQ-5D VAS ranges from 0 (worst health state) to 100 (best health state). An increase from baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.||units on a scale||Standard Error|Least Squares Mean
687165|NCT01480076|Secondary|Change From Baseline in the Activities Limitation Scale of the Patient-Reported Indices for Multiple Sclerosis (PRIMUS) at Months 3, 6, 9, and 12|The PRIMUS activity measure is a 15-item assessment of patient-reported activities of daily living. The total score was calculated as sum of all 15 items converted into a 0-30 range, where missing items were imputed by average of non-missing total when no more than 50% of items were missing (otherwise, the total score is missing). Higher score indicates worse condition. A decrease from Baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.||units on a scale||Standard Error|Least Squares Mean
687166|NCT01480076|Secondary|Change From Baseline in MSIS-29 Psychological Score at Months 3, 6, 9, and 12|The MSIS-29 is a disease specific patient-reported outcome measure that has been developed and validated to examine the physical and psychological impact of MS from a patient's perspective; it measures 20 physical items and 9 psychological items. Sum of 9 psychological condition items converted into a 0-100 score range, where missing items are imputed by average of total of non-missing items when no more than 50% are missing (otherwise the total score is missing). A lower total score indicates less psychologically-related impact while a higher total score indicates greater psychologically-related impact on a participant's functioning. Decreases from Baseline indicate improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.||units on a scale||Standard Error|Least Squares Mean
687167|NCT01480076|Secondary|Change From Baseline in the Multiple Sclerosis Impact Scale (MSIS-29) Physical Score at Months 3, 6, 9, and 12|The MSIS-29 is a disease specific patient-reported outcome measure that has been developed and validated to examine the physical and psychological impact of MS from a patient’s perspective; it measures 20 physical items and 9 psychological items. Sum of 20 physical condition items converted into a 0-100 score range, where missing items are imputed by average of total of non-missing items when no more than 50% are missing (otherwise the total score is missing). A lower total score indicates less physically-related impact while a higher total score indicates greater physically-related impact on a participant's functioning. Decreases from Baseline indicate improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.||units on a scale||Standard Error|Least Squares Mean
687168|NCT01480076|Secondary|Change From Baseline in the MCS of the SF-36 At Months 3, 6, 9, and 12|The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. Scores on each item are summed and averaged (range: 0=worst to 100=best). Increases from baseline indicate improvement. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.||units on a scale||Standard Error|Least Squares Mean
687169|NCT01480076|Secondary|Change From Baseline in the PCS of the SF-36 at Months 3, 6, 9, and 12: Responders Versus Non-responders|The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. Scores on each item are summed and averaged (range: 0=worst to 100=best). Increases from baseline indicate improvement. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12). In contrast to the primary endpoint, this analysis was done using data from both responder and non-responder groups; therefore, 'responder group' and 'visit by responder group interaction' were included as fixed effects.|Baseline, Months 3, 6, 9, 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.||units on a scale||Standard Error|Least Squares Mean
687170|NCT01480076|Primary|Change From Baseline in the Physical Component Scale (PCS) of the Short Form 36 Health Status Questionnaire (SF-36) At Months 3, 6, 9, and 12: Responders|The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the mental component summary (MCS) score of the SF-36. Scores on each item are summed and averaged (range: 0=worst to 100=best). Increases from baseline indicate improvement. Within-group least squares means are presented.|Baseline, Months 3, 6, 9, 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.||units on a scale||Standard Error|Least Squares Mean
687171|NCT01479868|Secondary|Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study drug and up to Day 126 that were absent before treatment or that worsened relative to pre-treatment state.|Week 1 to Week 72|Safety population included all participants who received at least 1 dose of study drug.||participants|||Number
687172|NCT01479868|Secondary|Change From Baseline in CD4+ Cell Count in Percentage||Baseline (Day 1), Week 2, 4, 8, 12, 16, 20, 24, 28, 36, 42, 48, 52, 60 and 72|"Participants who received potent anti-HIV treatment with a combination of more than 3 antiretroviral therapies to reduce HIV RNA viral load to undetectable levels were analyzed. Here, n is the number of participants analyzed for this outcome measure at spcific time points."||percentage of lymphocyte||Standard Deviation|Mean
687173|NCT01479868|Secondary|Mean Change From Baseline in CD4+ Cell Count||Baseline (Day 1), Week 2, 4, 8, 12, 16, 20, 24, 28, 36, 42, 48, 52, 60 and 72|"Participants who received potent anti-HIV treatment with a combination of more than 3 antiretroviral therapies to reduce HIV RNA viral load to undetectable levels were analyzed. Here, n is the number of participants analyzed for this outcome measure at spcific time points."||cell counts per microliter||Standard Deviation|Mean
687174|NCT01479868|Secondary|Mean Change From Baseline in Log10 Plasma Human Immunodeficiency Virus (HIV) Viral Load||Baseline (Day 1), Week 2, 4, 8, 12, 16, 20, 24, 28, 36, 42, 48, 52, 60 and 72|"Participants who received potent anti-HIV treatment with a combination of more than 3 antiretroviral therapies to reduce HIV RNA viral load to undetectable levels were analyzed. Here n signifies participants evaluable for this measure at specified time point."||copies per milliliter||Standard Deviation|Mean
687175|NCT01479868|Secondary|Percentage of Human Immunodeficiency Virus (HIV) Participants With Virologic Failure|Participants had confirmed HIV virologic failure if HIV viral load values were greater than or equal to 50 or 200 copies/mL among those who previously had less than 50 copies/mL.|Baseline to Week 72.|Participants who received potent anti-HIV treatment with a combination of more than 3 anti-antiretroviral therapies to reduce HIV RNA viral load to undetectable levels were analyzed.||percentage of participants|||Number
687176|NCT01479868|Secondary|Percentage of Participants With Normalized Alanine Aminotransferase Levels|Participants with normalized alanine aminotransferase levels observed whose alanine aminotransferase levels were out of range at Baseline.|Baseline up to Week 72|"The ITT population included all participants who received at least 1 dose of study drug. Here N signifies participants evaluable for this measure."||percentage of participants|||Number
687177|NCT01479868|Secondary|Percentage of Participants With Viral Relapse|Participants were considered to have a viral relapse when, at actual end of treatment, HCV RNA levels were less than 25 IU per mL undetectable; and during the follow-up period, HCV RNA levels were more than or equal to 25 IU per mL.|Week 1 to 72|"The ITT population included all participants who received at least 1 dose of study drug. Here, N (number of participants analyzed) is the number of participants analyzed for this outcome measure."||percentage of participants|||Number
687178|NCT01479868|Secondary|Percentage of Participants With Viral Breakthrough|Confirmed increase of more than 1 log10 IU per mL in HCV RNA level from the lowest level reached, or a confirmed HCV RNA level of more than 100 IU per mL in participants whose HCV RNA levels had previously been below the limit of quantification (less than 25 IU per mL detectable) or undetectable (less than 25 IU per mL undetectable), while on study therapy.|Week 1 to 48|The ITT population included all participants who received at least 1 dose of study drug.||percentage of participants|||Number
687179|NCT01479868|Secondary|Percentage of Participants With On-treatment Failure|Participants were considered as an on-treatment failure if, at actual end of treatment (EOT), there was confirmed detectable HCV RNA levels.|Week 1 to 48|The ITT population included all participants who received at least 1 dose of study drug.||percentage of participants|||Number
687180|NCT01479868|Secondary|Percentage of Participants With Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Less Than (<) 25 International Units (IU/mL) Undetectable or Detectable/Undetectable|Percentage of participants with HCV RNA less than (<) 25 IU/mL undetectable (undet.) or detectable (det.)/undetectable at specific time points were observed.|Week 4, 12, 24, 36, and 48|"ITT population included all participants who had at least 1 dose of study drug. Here, N (number of participants analyzed) is the number of participants analyzed for this outcome measure, n is the number of participants analyzed for this outcome measure at specific time points."||percentage of participants|||Number
687181|NCT01479868|Secondary|Percentage of Participants With Sustained Virologic Response at Week 24 (SVR 24)|The SVR 24 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) levels less than (<) 25 international unit per milliliter (IU/mL) undetectable at the actual end of treatment (EOT), and HCV RNA levels <25 IU/mL undetectable or HCV RNA levels <25 IU/mL detectable at 24 weeks after end of treatment.|24 weeks after end of treatment (Week 24 or 48)|The ITT population included all perticipants who had at least 1 dose of study drug.||percentage of participants|||Number
687189|NCT01479777|Primary|Change in Motor and Sensory Scores of the ASIA Impairment Scale (AIS)|"Change in motor, pin prick, and light touch score components of the ASIA Impairment scale (AIS) after 8 weeks of stepping FES in persons with spinal cord injury. The AIS evaluates motor and sensory function and comprises motor (min 0, max 100), pin prick (min 0, max 112), and light touch (min 0, max 112) scores. Higher scores represent better functional outcome.
AIS Classificatrion:
A = Complete: No motor or sensory function is preserved in the sacral segments S4-S5.
B = Incomplete: Sensory but not motor function is preserved below the neurological level and includes the sacral segments S4-S5.
C = Incomplete: Motor function is preserved below the neurological level, and more than half of key muscles below the neurological level have a muscle grade less than 3.
D = Incomplete: Motor function is preserved below the neurological level, and at least half of key muscles below the neurological level have a muscle grade of 3 or more.
E = Normal: motor and sensory function are normal."|Baseline, 8 weeks|||scores on AIS Scale||Full Range|Mean
687190|NCT01479764|Secondary|Time From Start of Study Drug Administration to Operating Room Discharge-ready|The time of operating room discharge readiness was determined by the surgical team based on clinical evaluations.|Day 1|The analysis population consisted of all randomized participants who received at least one dose of study drug (sugammadex or neostigmine/glycopyrrolate).||minutes||95% Confidence Interval|Least Squares Mean
687191|NCT01479764|Primary|Incidence of Residual Neuromuscular Blockade (NMB) as Defined by a Train-of-Four (TOF) Ratio <0.9 at Post Anesthesia Care Unit (PACU) Entry|Neuromuscular functioning was monitored by applying four TOF electrical stimulations to the ulnar nerve and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (height) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB, with a higher ratio indicating greater recovery from NMB. A T4/T1 Ratio of <0.9 is indicative of residual NMB.|At PACU entry on Day 1|The analysis population consisted of all randomized participants who received at least one dose of study drug (sugammadex or neostigmine/glycopyrrolate) and had a reliable TOF measurement at PACU entry.||participants|||Number
687192|NCT01479725|Primary|Global Response Assessment (GRA)|The GRA measures overall improvement with therapy. The patient's response describes their current condition compared to before they received hyperbaric oxygen therapy (HBOT). Responses are: 1 Markedly Worse, 2 Moderately Worse, 3 Mildly Worse, 4 Unchanged, 5 Mildly Better, 6 Moderately Better and 7 Markedly Better.|3 months post treatment|||number of participants|||Number
687193|NCT01479621|Other Pre-specified|Change From Baseline In Weekly Average Of Daily Evening Peak Expiratory Flow (PEF) Over The 12-Week Treatment Period Inclusive of Flovent Diskus Data|"Peak expiratory flow was determined in the AM and in the PM, before administration of study or rescue medications using a handheld electronic peak flow meter. The highest value of triplicate measurements obtained was recorded by the subject's diary device.
PM PEF baseline was defined as the average of recorded (nonmissing) PM PEF assessments over the 7 days directly preceding first study drug intake.
The p-values for the treatment comparisons to placebo are from an MMRM model including all treatment groups: change from baseline = baseline PEF + sex + age + treatment + visit + treatment*visit with an unstructured covariance matrix assumed."|Baseline (Days -7 to 1, am pre-dose), During Study (Days 2-84 am pre-dose)|Full analysis set, (participants who contributed >=1 to the analysis). Data from one site omitted due to GCP concerns.||liters/minute||Standard Error|Least Squares Mean
687194|NCT01479621|Other Pre-specified|Change From Baseline In Weekly Average Of Daily Trough (Predose And Pre-Rescue Bronchodilator) Morning Peak Expiratory Flow (PEF) Over The 12-Week Treatment Period Inclusive of Flovent Diskus Data|"Peak expiratory flow was determined in the AM and in the PM, before administration of study or rescue medications using a handheld electronic peak flow meter. The highest value of triplicate measurements obtained was recorded by the subject's diary device.
On mornings for which a treatment visit was scheduled (TV1 through TV9), the PEF was measured and recorded at the investigational site visit.
Baseline trough AM PEF was defined as the average of recorded (non-missing) trough AM PEF assessments over the 7 days directly preceding first study drug intake.
The p-values for the treatment comparisons to placebo are from an MMRM model including all treatments: change from baseline = baseline PEF + sex + age + treatment + visit + treatment*visit with an unstructured covariance matrix assumed."|Baseline (Days -7 to 1, am pre-dose), During Study (Days 2-84 am pre-dose)|Full analysis set, (participants who contributed >=1 to the analysis). Data from one site omitted due to GCP concerns.||liters/minute||Standard Error|Least Squares Mean
687195|NCT01479621|Other Pre-specified|Change From Baseline In Trough (Morning Predose And Pre-Rescue Bronchodilator) Forced Expiratory Volume In 1 Second (FEV1) Over The 12-Week Treatment Period Inclusive of Flovent Diskus Data|"Trough FEV1 was measured electronically by spirometry at morning (AM) investigational site visits, before administration of the AM dose of study drug and before albuterol/salbutamol administration. The highest FEV1 value from 3 acceptable and 2 reproducible maneuvers was used. All FEV1 data were submitted to a central reading center for evaluation.
The p-values for the treatment comparisons to placebo are from an MMRM model including data from all treatments: change from baseline = baseline FEV1 + sex + age + treatment + visit + treatment*visit with an unstructured covariance matrix assumed."|Baseline (Day 1, pre-dose), During Study (Days 7, 14, 28, 56 and 84 pre-dose)|Full analysis set, (participants who contributed >=1 to the analysis). Data from one site omitted due to GCP concerns.||liters||Standard Error|Least Squares Mean
687196|NCT01479621|Secondary|Oropharyngeal Exam Findings at Each Study Visit|"Oropharyngeal examinations for visual evidence of oral candidiasis were conducted at all study visits. If the visual oropharyngeal examination was abnormal at the screening visit, the subject was excluded from entering the study and subjects with an abnormal oropharyngeal exam on Day 1 were not eligible for randomization. Any visual evidence of oral candidiasis during the treatment period of the study was evaluated by obtaining and analyzing a swab of the suspect area. Appropriate therapy was to be initiated immediately at the discretion of the investigator and was not to be delayed for culture confirmation. Subjects with a culture-positive infection could continue participation in the study on appropriate anti-infective therapy, provided this therapy was not prohibited by the protocol. If a subject required a protocol-prohibited medication for therapy, the subject was to be discontinued from the study.
Data format: Time frame, <signs of oral candidiasis?> yes or no"|Screening (week -3 to -2), Baseline (Week 0), Weeks 1, 2, 4, 8, 12|Safety population||Participants|||Count of Participants
687197|NCT01479621|Secondary|Patients With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period|An adverse event was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relationship of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 -84|Safety analysis set||Participants|||Count of Participants
687198|NCT01479621|Secondary|Time of Maximum Concentration (Tmax) of Fp|Approximately 20% of subjects randomized to the study and distributed across preselected study sites were to participate in fluticasone propionate pharmacokinetic assessments (the pharmacokinetic cohort). Subjects who had received fluticasone propionate in any form (orally, inhaled, or nasal) within 14 days of Day 1 were not permitted to participate in pharmacokinetic assessments.|Day 1: predose (within 10 minutes of treatment administration), and 5, 10, 15, 30, and 45 minutes, 1 hour, 1 hour 15 minutes, 1 hour 30 minutes, and 2, 4, 8, and 12 hours postdose|Pharmacokinetics analysis set. Placebo samples not included in these results.||hours||Standard Deviation|Mean
687199|NCT01479621|Secondary|Maximum Observed Plasma Concentration (Cmax) of Fp|Approximately 20% of subjects randomized to the study and distributed across preselected study sites were to participate in fluticasone propionate pharmacokinetic assessments (the pharmacokinetic cohort). Subjects who had received fluticasone propionate in any form (orally, inhaled, or nasal) within 14 days of Day 1 were not permitted to participate in pharmacokinetic assessments.|Day 1: predose (within 10 minutes of treatment administration), and 5, 10, 15, 30, and 45 minutes, 1 hour, 1 hour 15 minutes, 1 hour 30 minutes, and 2, 4, 8, and 12 hours postdose|Pharmacokinetics analysis set. Placebo samples not included in these results.||pg/mL||Standard Deviation|Mean
687200|NCT01479621|Secondary|Area Under The Curve From Time 0 Until The Last Measurable Concentration (AUC0-t) of Fp|Approximately 20% of subjects randomized to the study and distributed across preselected study sites were to participate in fluticasone propionate pharmacokinetic assessments (the pharmacokinetic cohort). Subjects who had received fluticasone propionate in any form (orally, inhaled, or nasal) within 14 days of Day 1 were not permitted to participate in pharmacokinetic assessments.|Day 1: predose (within 10 minutes of treatment administration), and 5, 10, 15, 30, and 45 minutes, 1 hour, 1 hour 15 minutes, 1 hour 30 minutes, and 2, 4, 8, and 12 hours postdose|Pharmacokinetics analysis set. Placebo samples not included in these results.||pg*hr/mL||Standard Deviation|Mean
687201|NCT01479621|Secondary|Kaplan-Meier Estimate of Probability of Remaining in the Study at Week 12|The time to withdrawal due to stopping criteria was compared between the treatment groups with the log rank test. The Kaplan-Meier estimate of the probability of remaining in the study at week 12 with 95% CI was presented by treatment group. Subjects who completed the study were censored at the date of completion, subjects who withdrew for reasons other than stopping criteria were censored at the time of withdrawal. Stopping criteria were based on day subject first met stopping criteria, using subject's diary data and asthma exacerbations recorded in CRF.|Day 1 to Day 84|Full analysis set||probability||95% Confidence Interval|Number
687202|NCT01479621|Secondary|Change From Baseline in the Percentage of Rescue-Free 24-hour Periods During the 12-Week Treatment Period|"The number of inhalations of rescue medication used each day and each night was recorded in the subject’s diary device.
Change from baseline in the percentage of rescue-free 24-hour periods was analyzed with a marginal (also called population averaged) logistic model. The model included 2 time points of measurement for each subject: the baseline and the treatment period. The model contained covariates for sex, age, and treatment. The model for the 2 time points was considered as an incomplete randomized block model, with each subject as a block, receiving the baseline level in 1 sub-block and either active treatment or placebo in the other sub-block. The generalized estimating equation (GEE) algorithm was used to fit the model, using a robust estimator for the variance which provided a proper adjustment for possible correlation between the 2 measurements on each subject.
Measure type are estimated mean and measure of dispersion is the standard error of the estimated mean."|Baseline (Days -7 to -1), During Study (Days 1-84)|Full analysis set||percentage of total 24 hour periods||Standard Error|Mean
687203|NCT01479621|Secondary|Change From Baseline In Weekly Average Of Daily Evening Peak Expiratory Flow (PEF) Over The 12-Week Treatment Period|"Peak expiratory flow was determined in the AM and in the PM, before administration of study or rescue medications using a handheld electronic peak flow meter. The highest value of triplicate measurements obtained was recorded by the subject's diary device.
PM PEF baseline was defined as the average of recorded (nonmissing) PM PEF assessments over the 7 days directly preceding first study drug intake.
The p-values for the treatment comparisons to placebo are from an MMRM model excluding FLOVENT DISKUS data: change from baseline = baseline PEF + sex + age + treatment + visit + treatment*visit with an unstructured covariance matrix assumed."|Baseline (Days -7 to 1, am pre-dose), During Study (Days 2-84 am pre-dose)|Full analysis set, (participants who contributed >=1 to the analysis). Data from one site omitted due to GCP concerns. Flovent Diskus data was used for confirmatory and exploratory endpoints (see outcome #13).||liters/minute||Standard Error|Least Squares Mean
687204|NCT01479621|Secondary|Change From Baseline In Weekly Average Of Daily Trough (Predose And Pre-Rescue Bronchodilator) Morning Peak Expiratory Flow (PEF) Over The 12-Week Treatment Period|"Peak expiratory flow was determined in the AM and in the PM, before administration of study or rescue medications using a handheld electronic peak flow meter. The highest value of triplicate measurements obtained was recorded by the subject's diary device.
On mornings for which a treatment visit was scheduled (TV1 through TV9), the PEF was measured and recorded at the investigational site visit.
Baseline trough AM PEF was defined as the average of recorded (non-missing) trough AM PEF assessments over the 7 days directly preceding first study drug intake.
The p-values for the treatment comparisons to placebo are from an MMRM model excluding FLOVENT DISKUS data: change from baseline = baseline PEF + sex + age + treatment + visit + treatment*visit with an unstructured covariance matrix assumed."|Baseline (Days -7 to 1, am pre-dose), During Study (Days 2-84 am pre-dose)|Full analysis set, (participants who contributed >=1 to the analysis). Data from one site omitted due to GCP concerns. Flovent Diskus data was used for confirmatory and exploratory endpoints (see outcome #12).||liters/minute||Standard Error|Least Squares Mean
687205|NCT01479621|Primary|Change From Baseline In Trough (Morning Predose And Pre-Rescue Bronchodilator) Forced Expiratory Volume In 1 Second (FEV1) Over The 12-Week Treatment Period|"Trough FEV1 was measured electronically by spirometry at morning (AM) investigational site visits, before administration of the AM dose of study drug and before albuterol/salbutamol administration. The highest FEV1 value from 3 acceptable and 2 reproducible maneuvers was used. All FEV1 data were submitted to a central reading center for evaluation.
The p-values for the treatment comparisons to placebo are from an MMRM model excluding FLOVENT DISKUS data: change from baseline = baseline FEV1 + sex + age + treatment + visit + treatment*visit with an unstructured covariance matrix assumed."|Baseline (Day 1, pre-dose), During Study (Days 7, 14, 28, 56 and 84 pre-dose)|Full analysis set, (participants who contributed >=1 to the analysis). Data from one site omitted due to GCP concerns. Flovent Diskus data was used for confirmatory and exploratory endpoints (see outcome #11).||liters||Standard Error|Least Squares Mean
687206|NCT01479595|Secondary|Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO)|FeNO was assessed as a measure of airway inflammation. An FeNO machine was used to obtain the FeNO measurements. FeNO measurements were obtained prior to the spirometry assessments.|baseline, 12 weeks|Participants from the per-protocol analysis set were considered for the analysis. Only participants who had both baseline and week 12 values were included in the analysis.||parts per billion (ppb)||Standard Error|Least Squares Mean
687207|NCT01479595|Secondary|Lowest Plasma Concentration Observed During a Dosing Interval at Steady State (Cmin,ss) of the VAK694 Analyte|Blood samples were obtained to measure Cmin,ss.|days 1 (pre-dose and 2 hours post-dose), 15, 29 (pre-dose and 2 hours post-dose), 43, 57 (pre-dose and 2 hours post-dose), 71, 85 (pre-dose and 2 hours post-dose), 99, 113, 141, 183|Participants from the per-protocol analysis set were considered for the analysis. Only participants who had week 12 values were included in the analysis.||ug/mL||Standard Deviation|Mean
687208|NCT01479595|Secondary|Lowest Plasma Concentration Observed During a Dosing Interval at Steady State (Cmin,ss) of the QAX576 Analyte|Blood samples were obtained to measure Cmin,ss.|days 1 (pre-dose and 2 hours post-dose), 15, 29 (pre-dose and 2 hours post-dose), 43, 57 (pre-dose and 2 hours post-dose), 71, 85 (pre-dose and 2 hours post-dose), 99, 113, 141, 183|Participants from the per-protocol analysis set were considered for the analysis. Only participants who had week 12 values were included in the analysis.||ng/mL||Standard Deviation|Mean
687209|NCT01479595|Secondary|Observed Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax,ss) of the VAK694 Analyte|Blood samples were obtained to measure Cmax,ss.|days 1 (pre-dose and 2 hours post-dose), 15, 29 (pre-dose and 2 hours post-dose), 43, 57 (pre-dose and 2 hours post-dose), 71, 85 (pre-dose and 2 hours post-dose), 99, 113, 141, 183|Participants from the per-protocol analysis set were considered for the analysis. Only participants who had week 12 values were included in the analysis.||ug/mL||Standard Deviation|Mean
687210|NCT01479595|Secondary|Observed Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax,ss) of the QAX576 Analyte|Blood samples were obtained to measure Cmax,ss.|days 1 (pre-dose and 2 hours post-dose), 15, 29 (pre-dose and 2 hours post-dose), 43, 57 (pre-dose and 2 hours post-dose), 71, 85 (pre-dose and 2 hours post-dose), 99, 113, 141, 183|Participants from the per-protocol analysis set were considered for the analysis. Only participants who had week 12 values were included in the analysis.||ng/mL||Standard Deviation|Mean
687211|NCT01479595|Secondary|Number of Participants With Anti-QAX576 Antibodies or Anti-VAK694 Antibodies|Anti-QAX576 and anti-VAK694 antibodies in serum were analyzed.|12 weeks|All randomized participants||Participants|||Number
687212|NCT01479595|Secondary|Change From Baseline in Maximum Expiratory Flow|Maximum expiratory flow was assessed using central spirometry according to the American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines.|Baseline and 12 weeks|Participants from the per-protocol analysis set were considered for the analysis. Only participants who had both baseline and week 12 values were included in the analysis.||L/sec||Standard Deviation|Mean
687213|NCT01479595|Secondary|Morning and Evening Peak Expiratory Flow (PEF) Rate|Morning and evening PEFs were recorded on an electronic diary (e-diary). PEF was assessed twice daily approximately 12 hours apart and the measurements were recorded in the e-diary.|Baseline and 12 weeks|No analysis was performed on the collected data with the eDiary device due to overall poor data quality (values were obtained that were not physiologically possible) and high variability. Therefore, there is no data to present for this outcome measure.|||||
687214|NCT01479595|Secondary|Change in Asthma Quality of Life Questionnaire (AQLQ) Score|"The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments that are most important to patients with asthma. It consists of 4 domains: symptoms, emotions., exposure to environmental stimuli and activity limitation.
Patients were asked to recall their experiences during the previous 2 weeks and to score each item on a 7-point scale. The scale ranges from 1 to 7. The overall AQLQ score was the mean response to all 32 questions. Higher scores represent better outcomes."|Baseline and 12 weeks|Participants from the per-protocol analysis set were considered for the analysis. Only participants who had both baseline and week 12 values were included in the analysis.||score on a scale||Standard Error|Least Squares Mean
687215|NCT01479595|Secondary|Change in Forced Expiratory Volume in One Second (FEV1)|FEV1 was assessed using central spirometry according to the American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines.|Baseline and 12 weeks|Participants from the per-protocol analysis set were considered for the analysis. Only participants who had both baseline and week 12 values were included in the analysis.||Liters||Standard Error|Least Squares Mean
687216|NCT01479595|Primary|Change From Baseline in Asthma Control Questionnaire (ACQ) Score|The ACQ consists of 7 questions assessing symptoms, rescue medication use and lung function. Except for lung function (FEV1), each question was scored on a 7-point scale where 0 = no impairment and 6 = maximum impairment. Scores ranged between 0 totally controlled to 6 (severely uncontrolled). Participants with a score below 1.0 are considered to have adequately controlled asthma. Participants with a score above 1.0 were considered not to be well controlled. A negative change from baseline indicates improvement.|Baseline and 12 weeks|Participants from the per-protocol analysis set were considered for the analysis. Only participants who had both baseline and week 12 values were included in the analysis.||score on a scale||Standard Error|Least Squares Mean
687217|NCT01479543|Secondary|Gastrointestinal and Immune Effects of Probiotics Consumption.|"Effect on the systemic and adaptive immune system. This will be measured by means of lymphocite populations and plasma cytokine present on blood, IgAs on serum (at zero time and after four weeks of treatment), IgAs on saliva and faeces and AGCC (at zero time and after four weeks and two more weeks).
Gastrointestinal effects will be measured by means of gastrointestinal symptoms record and frequency and aspect of faeces, during the treatment and the following two weeks (wash-out period)."|At Time zero, after 4 weeks, and 2 later.||||||
687218|NCT01479543|Primary|Gastrointestinal Tolerance After Probiotic Consumption.|"Tolerance of these probiotic strains was determined using the gastrointestinal symptom rating scale (GSRS), daily recorded gastrointestinal symptoms and defecation frequency.Intolerance was defined as a symptom score of 2 or higher on the GSRS. The unit of measure is the number of participants was tolerant to the intervention."|4 weeks of the treatments. Daily recorded.|Calculation of simple size was based on the variance in the probiotic strain count (log strain CFU/g) in feces and a difference of 25% compared with the placebo. alfa: 0.05 power 90%||participants|||Number
687219|NCT01479530|Secondary|Change From Baseline in UPDRS Motor Score During ON Time|UPDRS is a 42-item rating scale designed to assess Parkinson's Disease-related disability and impairment using a patient interview and a physical examination. It has 4 parts and 4 subsection scores. A higher score indicates a worse outcome. I: mentation, behaviour and mood symptoms - 0 to 16; II: ADL - 0 to 52; III: motor function - 0 to 108; IV: complications of dopaminergic therapy - 0 to 23. Subsection scores for I to III are used to calculate a total score that ranges from 0 (no disability) to 176 (total dependence).|Baseline and Week 16|FAS; LOCF||units on a scale||Standard Error|Mean
687220|NCT01479530|Secondary|Change From Baseline in UPDRS-ADL Score During OFF Time|Unified Parkinson's Disease Rating Scale (UPDRS) is a 42-item rating scale designed to assess Parkinson's Disease-related disability and impairment using a patient interview and a physical examination. It has 4 parts and 4 subsection scores. A higher score indicates a worse outcome. I: mentation, behaviour and mood symptoms - 0 to 16; II: activities of daily living (ADL) - 0 to 52; III: motor function - 0 to 108; IV: complications of dopaminergic therapy - 0 to 23. Subsection scores for I to III are used to calculate a total score that ranges from 0 (no disability) to 176 (total dependence).|Baseline and Week 16|FAS; LOCF||units on a scale||Standard Error|Mean
687221|NCT01479530|Secondary|Clinical Status Using CGI-I Score During ON Time|Clinical Global Impression - Global Improvement (CGI-I) is a single-item rating scale used to evaluate a patient's condition relative to baseline on a 7-point scale, regardless of whether the improvement is related to the investigational medicinal product (IMP). The scale ranges from 1 (very much improved) to 7 (very much worse).|Week 16|FAS; last observation carried forward (LOCF)||units on a scale||Standard Error|Mean
687222|NCT01479530|Primary|Change From Baseline in Mean Total Daily OFF Time Using Parkinson's Disease Patient Diary|"Parkinson's Disease Patient Diary is a self-administered diary designed to assess motor fluctuations throughout the day. It is divided into 30-minute intervals, and the patient selects one of four options for each interval: asleep; off; on with no dyskinesia or without troublesome dyskinesia; or on with troublesome dyskinesia.
The Change From Baseline in Mean Total Daily OFF time is calculated by taking the difference between the average of the total daily OFF time at Weeks 4, 8, 12, and 16, and the Baseline Total Daily OFF Time."|Baseline and Weeks 4, 8, 12, and 16|Full-analysis set (FAS); observed cases (OC)||hours||Standard Error|Mean
687223|NCT01479517|Secondary|Naris Examination|Number of patients with an abnormal naris examination finding.|60 minutes post drug administration|||Participants|||Count of Participants
687224|NCT01479517|Secondary|The Proportion of Subjects Giving a Positive Response to Evaluation Question for Subjective Numbness Assessment (SNA) After the Procedure is Completed.||60 minutes|||participants|||Number
687225|NCT01479517|Secondary|The Incidence of Subjects Receiving Kovacaine Mist With Changes in Systolic and Diastolic Blood Pressure Exceeding +/- 25% of Preoperative Measurements Values.||60 minutes|||participants|||Number
687226|NCT01479517|Primary|The Proportion of Subjects Receiving Kovacaine Mist Who do Not Require Rescue Anesthesia During the Operative Dental Procedure||at 15 minutes, with +10 minute window|||participants|||Number
687227|NCT01479374|Secondary|Mean Conjunctival Redness at 24 Hours Duration of Action|A treatment efficacy CAC was performed 24 hours after drop instillation. Conjunctival redness was assessed by the investigator on a 0-4 scale (0=none to 4=extremely severe). Average of conjunctival redness score over both eyes was analyzed.|7, 15, and 20 minute timepoints, post-CAC on Day 1 of receiving treatment|Intent to treat (ITT). The analysis population included all randomized patients who received treatment and had post CAC data.||Units on a scale||Standard Deviation|Mean
687228|NCT01479374|Secondary|Mean Ocular Itching at 24 Hours Duration of Action|A treatment efficacy CAC was performed 24 hours after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=incapacitating itch). Average of ocular itching score over both eyes was analyzed.|3, 5, and 7 minute timepoints, post-CAC on Day 1 of receiving treatment|Intent to treat (ITT). The analysis population included all randomized patients who received treatment and had post CAC data.||Units on a scale||Standard Deviation|Mean
687229|NCT01479374|Secondary|Mean Total Redness at 24 Hours Duration of Action|A treatment efficacy CAC was performed 24 hours after drop instillation. Total redness (0-12) is defined as the sum of ciliary redness (0-4 scale, from 0=none to 4=extremely severe), conjunctival redness (0-4 scale, from 0=none to 4=extremely severe), and episcleral redness (0-4 scale, from 0=none to 4=extremely severe). Average of total redness score over both eyes was analyzed.|7, 15, and 20 minute timepoints, post-CAC on Day 1 of receiving treatment|Intent to treat (ITT). The analysis population included all randomized patients who received treatment and had post CAC data.||Units on a scale||Standard Deviation|Mean
687230|NCT01479374|Secondary|Mean Conjunctival Redness at 16 Hours Duration of Action|A treatment efficacy CAC was performed 16 hours after drop instillation. Conjunctival redness was assessed by the investigator on a 0-4 scale (0=none to 4=extremely severe). Average of conjunctival redness score over both eyes was analyzed.|7, 15, and 20 minute timepoints, post-CAC on Day 14 of receiving treatment|Intent to treat (ITT). The analysis population included all randomized patients who received treatment and had post CAC data.||Units on a scale||Standard Deviation|Mean
687231|NCT01479374|Secondary|Mean Conjunctival Redness at Onset of Action|A treatment efficacy CAC was performed 27 minutes after drop instillation. Conjunctival redness was assessed by the investigator on a 0-4 scale (0=none to 4=extremely severe). Average of conjunctival redness score over both eyes was analyzed.|7, 15, and 20 minute timepoints, post-CAC on Day 21 of receiving treatment|Intent to treat (ITT). The analysis population included all randomized patients who received treatment and had post CAC data.||Units on a scale||Standard Deviation|Mean
687232|NCT01479374|Primary|Mean Ocular Itching at 16 Hours Duration of Action|A treatment efficacy CAC was performed 16 hours after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=incapacitating itch). Average of ocular itching score over both eyes was analyzed.|3, 5, and 7 minute timepoints, post-CAC on Day 14 of receiving treatment|Intent to treat (ITT). The analysis population included all randomized patients who received treatment and had post CAC data.||Units on a scale||Standard Deviation|Mean
687233|NCT01479374|Primary|Mean Ocular Itching at Onset of Action|A treatment efficacy CAC was performed 27 minutes after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=incapacitating itch). Average of ocular itching score over both eyes was analyzed.|3, 5, and 7 minute timepoints, post-CAC on Day 21 of receiving treatment|Intent to treat (ITT). The analysis population included all randomized patients who received treatment and had post CAC data.||Units on a scale||Standard Deviation|Mean
687234|NCT01479127|Secondary|Number of Participants With Product Quality Complaints (PQC) During the ABT-SLV187 Treatment Period||Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|ABT-SLV187 safety sample: participants who had at least one dose of the ABT-SLV187 study medication after the baseline assessment.||participants|||Number
687235|NCT01479127|Secondary|Ratio of Metabolite 3-OMD to Levodopa (M/P [AUC0-12]) After Administration of Oral L/C Tablets and Intra-jejunal Administration of ABT-SLV187|M/P (AUC0-12) after administration of the oral L/C tablets (Day -1) and intra-jejunal administration of ABT-SLV187 (Day 21).|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|PK sample: participants who completed PK assessments in both the oral L/C and ABT-SLV187 Treatment Periods.||ratio||Standard Deviation|Mean
687236|NCT01479127|Secondary|Degree of Fluctuation (2-12 Hours) After Administration of Oral L/C Tablets and Intra-jejunal Administration of ABT-SLV187|Degree of Fluctuation (calculated as [Cmax – Cmin] / Cavg)) of levodopa, carbidopa, and 3-OMD after administration of the oral L/C tablets (Day -1) and intra-jejunal administration of ABT-SLV187 (Day 21).|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|PK sample: participants who completed PK assessments in both the oral L/C and ABT-SLV187 Treatment Periods.||ratio||Standard Deviation|Mean
687237|NCT01479127|Secondary|AUC0-12/Dose0-12, AUC0-16/Dose0-16 After Administration of Oral L/C Tablets and Intra-jejunal Administration of ABT-SLV187|AUC0-12/Dose0-12 of levodopa, carbidopa, and 3-OMD after administration of the oral L/C tablets (Day -1) and intra-jejunal administration of ABT-SLV187 (Day 21). AUC0-16/Dose0-16 of levodopa, carbidopa, and 3-OMD after administration of intra-jejunal administration of ABT-SLV187 (Day 21).|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|PK sample: participants who completed PK assessments in both the oral L/C and ABT-SLV187 Treatment Periods.||µg*h/mL/mg||Standard Deviation|Mean
687238|NCT01479127|Secondary|The Area Under the Concentrations-time Curve From 0 to 12 and 0 to 16 Hours (AUC0-12, AUC0-16) After Administration of Oral L/C Tablets and Intra-jejunal Administration of ABT-SLV187|AUC0-12 and AUC0-16 of levodopa, carbidopa, and 3-OMD after administration of the oral L/C tablets (Day -1) and intra-jejunal administration of ABT-SLV187 (Day 21).|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|PK sample: participants who completed PK assessments in both the oral L/C and ABT-SLV187 Treatment Periods.||µg*h/mL||Standard Deviation|Mean
687239|NCT01479127|Secondary|Peak Plasma Concentration (Cmax), Average Plasma Concentration (Cavg), Trough Plasma Concentration (Cmin), and Cmin Within 2 and 12 Hours (Cmin [2-12 Hours]) After Administration of Oral L/C Tablets and Intra-jejunal Administration of ABT-SLV187|Cmax, Cavg, Cmin, and Cmin (2-12 hours) of levodopa, carbidopa, and 3-OMD after administration of the oral L/C tablets (Day -1) and intra-jejunal administration of ABT-SLV187 (Day 21). Cmin values for levodopa and carbidopa during the 16 hours of infusion were observed either at time 0 or 15 min after start of the infusion and were a result of drug washout prior to establishment of infusion.|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|PK sample: participants who completed PK assessments in both the oral L/C and ABT-SLV187 Treatment Periods.||µg/mL||Standard Deviation|Mean
687240|NCT01479127|Secondary|Time to Reach Peak Plasma Concentration (Tmax) After Administration of Oral Levodopa/Carbidopa (L/C) Tablets and Intra-jejunal Administration of ABT-SLV187|Tmax of levodopa, carbidopa, and its metabolite 3-O-methyldopa (3-OMD) after administration of oral L/C tablets and intra-jejunal administration of ABT-SLV187.|Baseline (Day -1): pre-dose; 15, 30, 45, 60 mins post-morning dose; every 30 mins thereafter for 12 hrs. Day 21: pre-dose; 15, 30, 45, 60 mins post-infusion; every 30 mins from hrs 1 to 12 post-infusion; every 2 hrs from 12 to 16 hrs post-infusion.|Pharmacokinetic (PK) sample: participants who completed PK assessments in both the oral L/C and ABT-SLV187 Treatment Periods.||hours||Standard Deviation|Mean
687241|NCT01479127|Primary|Mean Change From Baseline to the End of Treatment in Percentage of Ratings in the “Normal” State on the Treatment Response Scale (TRS) I|Participants were video recorded a total of 10 times for 1 to 2 minutes every 60 minutes while performing a standardized sequence of motor tasks: rest, finger taps, rapid alternating movement of hands, arising from chair and gait, including confirmation of postural stability. Based on these video recordings, a Video Evaluation Committee consisting of 3 neurologists individually evaluated the following Video Assessment and Treatment Response Scale (TRS) under blinded conditions: Finger Taps, Rapid Alternating Movement of Hands, Arising from Chair, Gait, Body Bradykinesia and Hypokinesia, Dyskinesia. The average of the neurologists’ evaluations was calculated as a percentage of ratings in the “Normal” state (ie, “mild OFF” to “ON with mild dyskinesia”) on the TRS I (total 10 assessments per day).|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|Full Analysis Set: participants who had data for baseline and at least one post-baseline efficacy measurement.||percentage of ratings||Standard Deviation|Mean
687242|NCT01479127|Primary|Number of Participants With Potentially Clinically Significant 12-lead Electrocardiogram (ECG) Results During the ABT-SLV187 Treatment Period|High potentially clinically significant Bazett's heart rate-corrected QT interval (QTcB) values were: 450 msec for males / 470 msec for females.|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|ABT-SLV187 safety sample: participants who had at least one dose of the ABT-SLV187 study medication after the baseline assessment.||participants|||Number
687243|NCT01479127|Primary|Number of Participants With Potentially Clinically Significant (PCS) Vital Signs Results During the ABT-SLV187 Treatment Period|↓=decrease, ↑=increase, BL=baseline, temp.=temperature, SBP=systolic blood pressure, Sup.=supine, Sta.=standing, DBP=diastolic blood pressure.|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|ABT-SLV187 safety sample: participants who had at least one dose of the ABT-SLV187 study medication after the baseline assessment.||participants|||Number
687244|NCT01479127|Primary|Number of Participants With Potentially Clinically Significant Urinalysis Results During the ABT-SLV187 Treatment Period||Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|ABT-SLV187 safety sample: participants who had at least one dose of the ABT-SLV187 study medication after the baseline assessment.||participants|||Number
687245|NCT01479127|Secondary|Clinical Global Impression - Severity (CGI-S) Score at Baseline and Clinical Global Impression - Improvement (CGI-I) Score at Baseline and End of Treatment|The CGI-S is a global assessment by the Investigator of current symptomatology and impact of illness on functioning. The ratings of the CGI-S are as follows: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, and among the most extremely ill. The CGI-I is a global assessment by the Investigator of the change in clinical status since the start of treatment. The CGI-I ratings are as follows: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse.|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|Full Analysis Set: participants who had data for baseline and at least one post-baseline efficacy measurement.||participants|||Number
687246|NCT01479127|Secondary|Schwab and England Activities of Daily Living Scale at Baseline and End of Treatment|The Schwab and England scale was used to rate the subject’s activities of daily living by recording the percentage score, ranging between being completely independent (100%) and totally dependent (10%).|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|Full Analysis Set: participants who had data for baseline and at least one post-baseline efficacy measurement.||units on a scale||Full Range|Median
687247|NCT01479127|Secondary|Modified Hoehn and Yahr Staging at Baseline and End of Treatment|Participant’s ON and OFF states staged according to the Modified Hoehn and Yahr criteria, an 8-point scale for staging: 0, No signs of disease; 1, Unilateral disease; 1.5, Unilateral plus axial involvement; 2, Bilateral disease; 2.5, Mild bilateral disease; 3, Mild to moderate bilateral disease; 4, Severe disability; and 5, Wheelchair bound or bedridden unless aided. ON time is when PD symptoms are well controlled by the drug. OFF time is when PD symptoms are not adequately controlled by the drug.|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|Full Analysis Set: participants who had data for baseline and at least one post-baseline efficacy measurement.||units on a scale||Full Range|Median
687248|NCT01479127|Secondary|Change From Baseline to the End of Treatment in the Japanese Version of Parkinson's Disease Questionnaire 39 (PDQ-39) Total Score and Domain Scores|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients, including Mobility, Activities of Daily Living, Emotional Well-being, Stigma, Social Support, Cognition, Communication, and Bodily Discomfort, as well as a Summary Index Total Score. Scores for each are on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|Full Analysis Set: participants who had data for baseline and at least one post-baseline efficacy measurement.||units on a scale||Standard Deviation|Mean
687249|NCT01479127|Secondary|Mean Change From Baseline to the End of Treatment in UPDRS Total Scores and Subscores|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The total score is the sum of the responses to the 31 questions (44 answers) that comprise Parts I-III of the scale. The total score ranges from 0-176, with 176 representing the worst (total) disability, and 0 no disability. The Part I Score is the sum of the answers to the 4 questions related to Mentation, Behavior and Mood, and ranges from 0-16. The Part II score is the sum of the answers to the 13 questions related to Activities of Daily Living, and ranges from 0-52. The Part III score is the sum of the 27 answers related to Motor Examination, and ranges from 0-108. The Part IV Score is the sum of the answers to the 11 questions related to Complications of Therapy, and ranges from 0-23. The Part IV dyskinesia subscore ranges from 0-12. For each part of the UPDRS, higher scores are associated with more disability.|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|Full Analysis Set: participants who had data for baseline and at least one post-baseline efficacy measurement.||units on a scale||Standard Deviation|Mean
687250|NCT01479127|Secondary|Baseline and Endpoint (End of Treatment) Video Scoring of Unified Parkinson's Disease Rating Scale (UPDRS) Items and Dyskinesia|Participants were video recorded a total of 10 times for 1 to 2 minutes every 60 minutes while performing a standardized sequence of motor tasks. Based on these video recordings, a Video Evaluation Committee consisting of 3 neurologists individually evaluated the video under blinded conditions using the following assessments: Tremor at Rest (UPDRS item #20), Finger Taps (UPDRS #23), Rapid Alternating Movement of Hands (UPDRS #25), Arising from Chair (UPDRS #27), Gait (UPDRS #29), Postural Stability (UPDRS #30), Body Bradykinesia and Hypokinesia (UPDRS #31), and Dyskinesia (evaluated with the Goetz Dyskinesia Rating Scale). The UPDRS score is the sum of the answers to individual questions, each of which are measured on a 5-point scale (0-4), with higher scores associated with more disability. The Goetz Dyskinesia Rating Scale is a 5-point scale of the severity of dyskinesias, from 0 (absent) to 4 (violent dyskinesias).|Baseline (Day -1), Endpoint (Day 21)|Full Analysis Set: participants who had data for baseline and at least one post-baseline efficacy measurement.||units on a scale||Standard Deviation|Mean
687251|NCT01479127|Secondary|Change From Baseline to the End of Treatment in Parkinson's Disease Diary Assessment|For each half hour period during 3 consecutive days prior to each assessment of the diary, participants (and/or their caregivers) entered into a diary whether they were asleep, in the ON motor state or in the OFF motor state in the following 5 grades: asleep, OFF, ON (no dyskinesia [D]), ON with non-troublesome dyskinesia (NTD), ON with troublesome dyskinesia (TD). ON time is when PD symptoms are well controlled by the drug. OFF time is when PD symptoms are not adequately controlled by the drug. Dyskinetic time is time with involuntary muscle movement. The ON or OFF times were calculated as the average of 3 daily times from the diaries. w/o = without, w/ = with|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|Full Analysis Set: participants who had data for baseline and at least one post-baseline efficacy measurement.||hours||Standard Deviation|Mean
687252|NCT01479127|Secondary|Mean Change From Baseline to the End of Treatment in Percentage of Ratings in the “OFF” and “Dyskinesia” States on the TRS I and the “Normal,” “OFF,” and “Dyskinesia” States on the TRS II|Participants were video recorded a total of 10 times for 1 to 2 minutes every 60 minutes while performing a standardized sequence of motor tasks: rest, finger taps, rapid alternating movement of hands, arising from chair and gait, including confirmation of postural stability. Based on these video recordings, a Video Evaluation Committee consisting of 3 neurologists individually evaluated the following Video Assessment and TRS under blinded conditions: Finger Taps, Rapid Alternating Movement of Hands, Arising from Chair, Gait, Body Bradykinesia and Hypokinesia, Dyskinesia for TRS I, with the addition of Tremor at Rest and Postural Stability for TRS II. The average of the 3 neurologists’ evaluations was calculated as a percentage of ratings in the “Normal” state (ie, “mild OFF” to “ON with mild dyskinesia”), the “Off” state (“moderate OFF” to “severe OFF”), and the “Dyskinesia” state (“ON with moderate dyskinesia” to “ON with severe dyskinesia”) on the TRS I or II.|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|Full Analysis Set: participants who had data for baseline and at least one post-baseline efficacy measurement.||percentage of ratings||Standard Deviation|Mean
687253|NCT01479127|Primary|Number of Participants With PCS Values in Special Laboratory Parameters During the ABT-SLV187 Treatment Period|M=male, F=female|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|ABT-SLV187 safety sample: participants who had at least one dose of the ABT-SLV187 study medication after the baseline assessment.||participants|||Number
687254|NCT01479127|Primary|Number of Participants With PCS Blood Biochemistry Results During the ABT-SLV187 Treatment Period|M=male, F=female, γ-GTP=gamma-glutamyl transpeptidase.|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|ABT-SLV187 safety sample: participants who had at least one dose of the ABT-SLV187 study medication after the baseline assessment.||participants|||Number
687255|NCT01479127|Primary|Number of Participants With Potentially Clinically Significant (PCS) Hematology Results During the ABT-SLV187 Treatment Period|M=male, F=female, MCV=mean corpuscular volume, MCH=mean corpuscular hemoglobin, MCHC=mean corpuscular hemoglobin concentration.|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|ABT-SLV187 safety sample: participants who had at least one dose of the ABT-SLV187 study medication after the baseline assessment.||participants|||Number
687256|NCT01479127|Primary|Number of Participants With AEs, SAEs, and AEs Leading to Discontinuation During the ABT-SLV187 Treatment Period|AE: any untoward medical occurrence in a participant that does not necessarily have a causal relationship with this treatment. SAE: an event that results in the death of a subject, is life threatening, results in hospitalization or prolongation of hospitalization, is a congenital anomaly, results in persistent or significant disability/incapacity, or other important medical event. Severity was rated as mild, moderate, or severe. AEs of special interest included: device-associated gastrointestinal disorders; cardiovascular fatalities; aspiration including aspiration pneumonia; a diagnosis of peripheral polyneuropathy (axonal, demyelinating or mixed type); possible symptoms of peripheral polyneuropathy; clinically significant weight loss. 'AEs at least possibly related' are defined as those that were assessed by investigator as probably related or possibly related.|From NJ placement to end of ABT-SLV187 Treatment Period (Day 21) +30 days|ABT-SLV187 safety sample: participants who had at least one dose of the ABT-SLV187 study medication after the baseline assessment.||participants|||Number
687257|NCT01479127|Primary|Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), and AEs Leading to Discontinuation During the Run-in Period|AE: any untoward medical occurrence in a participant that does not necessarily have a causal relationship with this treatment. SAE: an event that results in the death of a subject, is life threatening, results in hospitalization or prolongation of hospitalization, is a congenital anomaly, results in persistent or significant disability/incapacity, or other important medical event. Severity was rated as mild, moderate, or severe. AEs of special interest included: device-associated gastrointestinal disorders; cardiovascular fatalities; aspiration including aspiration pneumonia; a diagnosis of peripheral polyneuropathy (axonal, demyelinating or mixed type); possible symptoms of peripheral polyneuropathy; clinically significant weight loss. 'AEs at least possibly related' are defined as those that were assessed by investigator as probably related or possibly related.|During the Run-in period (up to approximately 28 days)|Full safety sample: participants who had at least one dose of oral levodopa-carbidopa study drug in the Run-in Period.||participants|||Number
687258|NCT01479010|Secondary|Oxygen Uptake Efficiency Slope||28 days||||||
687259|NCT01479010|Secondary|Total Exercise Time||28 days||||||
687260|NCT01479010|Secondary|Rate of Adverse Events and Hospitalizations||28 days||||||
687261|NCT01479010|Secondary|Correlation Between Interval Changes in Biomarkers, Peak VO2, and VE/VCO2||28 days||||||
687262|NCT01479010|Secondary|Interval Change From Baseline in Heart Failure Symptoms as Measured by Duke Activity Status Index (DASI)||28 days||||||
687263|NCT01479010|Secondary|Interval Change From Baseline in Biomarkers (High-sensitivity C-reactive Protein, Whole Blood Assay, Brain Natriuretic Peptide)||28 days||||||
687264|NCT01479010|Primary|Median Interval Change From Baseline in the Minute Ventilation and Carbon Dioxide Production (VE/VCO2 Slope)|VE/VCO2 slope will be measured during a standardized cardiopulmonary exercise test in which patients exercise on a treadmill while breathing through a mask.|28 days|Due to the small number of participants, results are not included to protect the privacy of individual participants.|||||
687265|NCT01479010|Primary|Median Interval Change From Baseline in Peak VO2|Peak VO2 will be measured during a standardized cardiopulmonary exercise test in which patients exercise on a treadmill while breathing through a mask.|28 days|Due to the small number of participants, results are not included to protect the privacy of individual participants.|||||
687266|NCT01478971|Secondary|Percentage of Participants Who Received a Whole Blood or Red Blood Cell Transfusion||12 months|Safety population||percentage of participants|||Number
687267|NCT01478971|Secondary|Percentage of Participants Who Received at Least One Intravenous Iron Dose|Participants received iron supplementation during the study to prevent iron deficiency and to maintain iron stores.|12 months|Safety population||percentage of participants|||Number
687347|NCT01477892|Primary|Premature Infant Pain Profile|"P0-P2 units on a scale
; changes in PIPP from baseline (P0) to procedure (needle puncture, P2)
PIPP (preterm infant pain profile)
min 0 ~ max 21
higher pain scale on higher score"|first puncture of skin(P0), 10min after remifentanil infusion (P1), 15min after remifentanil infusion (needle puncture, P2), 10min after remifentanil stop|||units on a scale||Standard Deviation|Mean
687268|NCT01478971|Secondary|Percentage of Participants With Hemoglobin Levels Greater Than 10 and Less Than or Equal to 11 g/dL|Percentage of participants with hemoglobin values within the hemoglobin range of 10-11 g/dL.|Months 1, 2, 3, 4, 5 and 6 of each treatment period|Full Analysis Population included all enrolled participants who received at least 1 dose of study treatment during the Peginesatide Treatment Period. n indicates the number of participants with available data at each time point.||percentage of participants|||Number
687269|NCT01478971|Secondary|Peginesatide Dose Deviations|Data collected by sponsor of study (Affymax), and sponsor did not provide aggregate summary data.|Months 6 - 12||||||
687270|NCT01478971|Secondary|Peginesatide Dosing|The starting dose, mean dose throughout the study, and mean dose during the last week of treatment of peginesatide.|Month 6 - 12|Participants who received at least 1 dose of study treatment during the Peginesatide Treatment Period.||mg||Standard Deviation|Mean
687271|NCT01478971|Primary|Percentage of Participants Undergoing Conversion to Peginesatide Injection||6 months|All participants who received at least one dose of study treatment.||percentage of participants|||Number
687272|NCT01478958|Secondary|Microvascular Reactivity (Laser Doppler Imaging With Iontophoresis)|Laser Doppler imaging (LDI) with iontophoresis of acetylcholine (Ach; endothelium-dependent vasodilation) and sodium nitroprusside (SNP; endothelium-independent vasodilation).|4 months||||||
687273|NCT01478958|Secondary|Vascular Stiffness by Pulse Wave Velocity (PWV), Pulse Wave Analysis (PWA) and Digital Volume Pulse (DVP)|PWV (m/s) PWA produces Augmentation Index (AIx; %) DVP produces Stiffness Index (SI; m/s) and Reflection Index (RI; %)|4 months||||||
687274|NCT01478958|Secondary|24-hour Ambulatory Blood Pressure|24-hour, daytime and night-time measures of systolic blood pressure (SBP), diastolic blood pressure (DBP), pulse pressure (PP; SBP-DBP) and heart rate (HR)|4 months||||||
687275|NCT01478958|Secondary|Cardiovascular Risk Factors (Lipids, Inflammatory Markers, Indices of Insulin Resistance, Cell Microparticles, Endothelial Progenitor Cells)|Data for fasting serum lipids (total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), TC:HDL-C ratio, low-density lipoprotein cholesterol (LDL-C), triacylglycerol (TAG)).|4 months||||||
687276|NCT01478958|Primary|Percent Change in Flow Mediated Dilatation (FMD)||Baseline, 4 months|Number of participants analyzed: n=171. n=24 were images of poor quality that could not be analyzed successfully.||post-occlusion diameter change as %||Standard Error|Mean
687277|NCT01478828|Secondary|Capture Difference in MYC Downregulation Between Treated Participants and Non-treated Patients|7. To compare the MYC downregulation between our prostatectomy samples treated with high-dose lovastatin and up to 21 matched prostatectomy reference samples from untreated patients from a pre-existing reference dataset.|1 year||||||
687278|NCT01478828|Secondary|Number of Participants Who Follow All of the Study Rules.|6. To assess the study compliance.|1 year||||||
687279|NCT01478828|Secondary|Capture the Associated Changes in Participants With Regards to the Relationship Between MYC and Increased Apoptosis.|5. To assess an association of pharmacodynamic target inhibition of MYC with markers of increased apoptosis (cleaved caspase-3) and proliferation (Ki-67).|1 year||||||
687280|NCT01478828|Secondary|Capture the Pharmacodynamic Changes in Participants After the Pre-treatment Biopsy.|4. To assess the relationship of pharmacodynamic target inhibition of MYC with pretreatment prostate biopsy Gleason sum, Ki-67, and degree of MYC overexpression.|1 year||||||
687281|NCT01478828|Secondary|Number and Type of Cholesterol Changes After Lovastatin Treatments.|3. To characterize the effect of continuous daily oral lovastatin on cholesterol level in this patient population, at the doses tested in this trial.|1 year||||||
687282|NCT01478828|Secondary|To Estimate What the Doses Given to Men With MYC Target Inhibition When Factoring in Their Tumor Biopsies Before and After Lovastatin Treatment.|2. To estimate an overall and per dose proportion of men with MYC target inhibition in prostate tumor tissue using paired tumor biopsies before and after lovastatin administration.|1 year||||||
687283|NCT01478828|Secondary|Number of Participants Who Experience Specific Adverse Events at Different Dosing Points Prior to Surgery.|1. To assess the tolerability and toxicity of the different doses of continuous daily oral lovastatin in generally healthy men with prostate cancer prior to surgery.|1 year||||||
687284|NCT01478828|Primary|Number of Participants That Can Achieve 60% MYC Modulation Response|To determine the dose of continuous daily oral lovastatin needed to achieve MYC down-regulation in prostatectomy specimens in intermediate-/high-risk localized prostate cancer patients.|1 year|||participants|||Number
687285|NCT01478620|Secondary|Time to First Early Recurrence [Days] After Clearance of uUTI Symptoms||During active treatment and follow up period (Day 0 - Day 37)||||||
687286|NCT01478620|Secondary|Proportion of Patients With Early Recurrence [Days] After Clearance of uUTI Symptoms||During active treatment and follow up period (Day 0 - Day 37)||||||
687287|NCT01478620|Secondary|Proportion of Patients Who Require Antibiotic Treatment Until Day 7||During active treatment period||||||
687288|NCT01478620|Secondary|Duration of uUTI Symptoms||During active treatment and follow up period (Day 0 - Day 37)||||||
687289|NCT01478620|Secondary|Severity of uUTI Symptoms on Day 37||Day 37||||||
687290|NCT01478620|Secondary|Severity of uUTI Symptoms on Day 7||Day 7||||||
687291|NCT01478620|Secondary|Proportion of Patients With no Symptoms Worse Than Mild on Day 7 (i.e. Responders)||Day 7||||||
687292|NCT01478620|Secondary|Incidence of Adverse Drug Reactions During the 7-day Treatment of uUTI Symptoms With Canephron® N in the Subgroup of Patients Who Take Canephron® N for at Least 7 Days||During active treatment period||||||
687293|NCT01478620|Primary|Incidence of Adverse Drug Reactions During 7-day Treatment of uUTI Symptoms With Canephron® N|No study drug related adverse drug reactions were registered.|During active treatment period (day 1 until day 7)|||Adverse Drug Reactions|||Number
687294|NCT01478594|Secondary|Progression-Free Survival Events by Tumor Placental Growth Factor (PIGF) RNA Level|"The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline tumor PIGF RNA level.
RNA was purified from biopsy tissue and measured using quantitative reverse transcription polymerase chain reaction (qRT-PCR). Since low cycle threshold (CT) values reflect high RNA expression, the inverse of CT values were used to derive tumor categories. RNA level is expressed relative to the observed median level."|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|Full analysis set with available tumor biopsy RNA samples||participants|||Number
687295|NCT01478594|Secondary|Progression-Free Survival Events by Tumor VEGF-D RNA Level|"The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline tumor VEGF-D RNA level.
RNA was purified from biopsy tissue and measured using quantitative reverse transcription polymerase chain reaction (qRT-PCR). Since low cycle threshold (CT) values reflect high RNA expression, the inverse of CT values were used to derive tumor categories. RNA level is expressed relative to the observed median level."|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|Full analysis set with available tumor biopsy RNA samples||participants|||Number
687296|NCT01478594|Secondary|Progression-Free Survival Events by Tumor VEGF-C / VEGF-A RNA Ratio|"The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline tumor VEGF-C/VEGF-A RNA ratio.
RNA was purified from biopsy tissue and measured using quantitative reverse transcription polymerase chain reaction (qRT-PCR). Since low cycle threshold (CT) values reflect high RNA expression, the inverse of CT values were used to derive tumor categories. RNA level is expressed relative to the observed median level."|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|Full analysis set with available tumor biopsy RNA samples||participants|||Number
687297|NCT01478594|Secondary|Progression-Free Survival Events by Tumor VEGF-C RNA Level|"The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline tumor VEGF-C RNA level.
RNA was purified from biopsy tissue and measured using quantitative reverse transcription polymerase chain reaction (qRT-PCR). Since low cycle threshold (CT) values reflect high RNA expression, the inverse of CT values were used to derive tumor categories. RNA level is expressed relative to the observed median level."|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|Full analysis set with available tumor biopsy RNA samples||participants|||Number
687298|NCT01478594|Secondary|Progression-Free Survival Events by Tumor VEGF-A Ribonucleic Acid (RNA) Level|"The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline tumor VEGF-A RNA level.
RNA was purified from biopsy tissue and measured using quantitative reverse transcription polymerase chain reaction (qRT-PCR). Since low cycle threshold (CT) values reflect high RNA expression, the inverse of CT values were used to derive tumor categories. RNA level is expressed relative to the observed median level."|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|Full analysis set with available tumor biopsy RNA samples||participants|||Number
687299|NCT01478594|Secondary|Progression-Free Survival Events by Serum Neuropilin Level|The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline serum neuropilin level. Neuropilin protein levels were quantified using enzyme-liked immunosorbent assay (ELISA); the level of protein is expressed relative to the observed median level.|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|Full analysis set with available serum protein samples||participants|||Number
687300|NCT01478594|Secondary|Progression-Free Survival Events by Serum Interleukin-8 (IL-8) Level|The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline serum interleukin-8 level. IL-8 protein levels were quantified using enzyme-liked immunosorbent assay (ELISA); the level of protein is expressed relative to the observed median level.|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|Full analysis set with available serum protein samples||participants|||Number
687301|NCT01478594|Secondary|Progression-Free Survival Events by Soluble Vascular Endothelial Growth Factor Receptor-3 (sVEGFR-3) Level|The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline serum sVEGFR-3 level. sVEGFR-3 protein levels were quantified using enzyme-liked immunosorbent assay (ELISA); the level of protein is expressed relative to the observed median level.|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|Full analysis set with available serum protein samples||participants|||Number
687302|NCT01478594|Secondary|Progression-Free Survival Events by Soluble Vascular Endothelial Growth Factor Receptor-2 (sVEGFR-2) Level|The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline serum sVEGFR-2 level. sVEGFR-2 protein levels were quantified using enzyme-liked immunosorbent assay (ELISA); the level of protein is expressed relative to the observed median level.|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|Full analysis set with available serum protein samples||participants|||Number
687303|NCT01478594|Secondary|Progression-free Survival Events by Serum VEGF-C / VEGF-A Ratio|The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline serum VEGF-C/VEGF-A ratio. VEGF-A and VEGF-C protein levels were quantified using enzyme-liked immunosorbent assay (ELISA); the ratio is expressed relative to the observed median.|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|Full analysis set with available serum protein samples||participants|||Number
687304|NCT01478594|Secondary|Progression-free Survival Events by Serum Vascular Endothelial Growth Factor-C (VEGF-C) Level|The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline serum VEGF-C level. VEGF-C protein levels were quantified using enzyme-liked immunosorbent assay (ELISA); the level of protein is expressed relative to the observed median level.|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|Full analysis set with available serum protein samples||participants|||Number
687305|NCT01478594|Secondary|Progression-free Survival Events by Serum Vascular Endothelial Growth Factor-A (VEGF-A) Level|The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline serum vascular endothelial growth factor-A (VEGF-A) level. VEGF-A protein levels were quantified using enzyme-liked immunosorbent assay (ELISA); the level of protein is expressed relative to the observed median level.|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|Full analysis set with available serum protein samples||participants|||Number
687306|NCT01478594|Secondary|Progression-free Survival Events by Lactate Dehydrogenase (LDH) Level|The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline serum lactate dehydrogenase status.|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|Full analysis set||participants|||Number
687307|NCT01478594|Secondary|Safety as Assessed by Physical Examination, Vital Signs, Laboratory Assessments, 12-lead Electrocardiogram (ECGs), and Adverse Events (AEs)|"An abnormality identified during a medical test is defined as an AE if the abnormality induced clinical signs or symptoms, required active intervention, interruption or discontinuation of study medication or was clinically significant in the investigator's opinion.
An AE was serious if it resulted in death, was life-threatening, resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, resulted in congenital anomaly or birth defect, required or prolonged inpatient hospitalization or other medically important event.
AEs, including abnormal clinical laboratory values, were graded using the National Cancer Institute Common Terminology Criteria for Grading Adverse Events (NCI-CTCAE) Version 4.03 per the following: 1=mild; 2= moderate; 3= severe; 4= life threatening; 5=death.
Treatment-related AEs were defined as events where the relationship to study drug was marked as probably or possibly, or was missing."|From first dose through 30 days after last dose of either tivozanib or bevacizumab, until the data cut-off date of 28 February 2014. The median duration of treatment was 168.0 days in the tivozanib (tiv) arm and 162.0 days in the bevacizumab (bev) arm.|The safety analysis set consisted of all randomized participants who received at least one dose of study drug (tivozanib or bevacizumab), analyzed according to the treatment actually received.||participants|||Number
687308|NCT01478594|Secondary|Health Related Quality of Life (HRQoL)|Time to deterioration in HRQoL measured by Colorectal cancer (CRC) subscale of the Functional Assessment of cancer Therapy Colorectal (FACT-C) scale, change in score from baseline using the European Quality of Life – 5 Dimensions (EQ-5D) and Fact Colorectal Symptom Index (FCSI) were not evaluated due to study closure.|3 years|Analysis was not performed due to study closure.|||||
687309|NCT01478594|Secondary|Time to Treatment Failure (TTF)|Time to Treatment Failure (TTF) is defined as the time from randomization to last dose date of tivozanib/bevacizumab. If a participant discontinued treatment for any reason, the participant was considered as an event. Participants remaining on treatment at the time of analysis were censored at date of last dose.|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|Full analysis set||months||95% Confidence Interval|Median
687310|NCT01478594|Secondary|Duration of Response (DoR)|Duration of response (DoR) is defined as the time from the date of the first documented response of CR or PR (whichever is first recorded) to documented progression or death. If a participant did not progress or had not died at the time of analysis, the duration of response was censored at the date of last tumor assessment. Duration of response is only defined for participants whose best overall response was CR or PR.|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|Participants with a best overall response of complete response (CR) or partial response (PR).||months||95% Confidence Interval|Median
687311|NCT01478594|Secondary|Objective Response Rate (ORR)|"Objective response rate is defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) confirmed a minimum of four weeks apart based on RECIST 1.1 criteria.
CR: Disappearance of all target and non-target lesions and no new lesions.
PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters and no progression of non-target lesions and no new lesions, or, disappearance of all target lesions and persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits and no new lesions."|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|Full analysis set||percentage of participants|||Number
687312|NCT01478594|Secondary|Overall Survival (OS)|Overall survival (OS) is defined as the time from the date of randomization until the documented date of death. Participants still alive at the time of analysis were censored on the last day the participant was known to be alive.|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|Full analysis set||months||95% Confidence Interval|Median
687313|NCT01478594|Secondary|Progression-Free Survival (PFS) Based on Independent Radiological Review (IRR)|The time from the date of randomization until the date of radiological disease progression assessed by the IRR or until death due to any cause, even in the absence of radiological progression.|3 years|Analysis was not performed due to study closure.|||||
687314|NCT01478594|Primary|Investigator-assessed Progression-Free Survival (PFS)|"The time from the date of randomization until objective tumor progression or death due to any cause. Objective tumor progression was determined through radiological imaging and based on the requirements of the Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1):
Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of existing non-target lesions or the appearance of one or more new lesions.
Participants who did not progress or had not died at the time of the analysis were censored at the date of last tumor assessment where non-progression was documented."|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|The full analysis set included all randomized participants.||months||95% Confidence Interval|Median
687315|NCT01478373|Secondary|DCR (CR+PR+SD) at the End of Treatment|DCR is defined as the proportion of patients with a best overall response of CR, PR and SD at the end of dovitinib treatment according to RECIST (version 1.1). Complete Response (CR): Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm 1;Partial Response (PR): At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm2. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD.|Up to 9 months of estimated treatment|Full Analysis Set: All subjects with histologically confirmed diagnosis of GIST who received at least one dose of study drug.||Percentage of Participants||90% Confidence Interval|Number
687316|NCT01478373|Secondary|Overall Survival (OS) of Patients Treated With Dovitinib|Outcome Measure Description: OS: time from the date of entry into the study to the date of death due to any cause. A patient who has not died by the date of the analysis cut-off would have the OS censored at the time of the last contact before the cut-off date.|21 months (9 months of estimated treatment plus 12 months of survival follow up)|Full Analysis Set: All subjects with histologically confirmed diagnosis of GIST who received at least one dose of study drug.||Months||95% Confidence Interval|Median
687317|NCT01478373|Secondary|Overall Response Rate (ORR) of Patients Treated With Dovitinib|Outcome Measure Description: ORR: proportion of patients whose best overall response is either complete response (CR) or partial response (PR) according to RECIST (version 1.1). Complete Response (CR): Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm 1;Partial Response (PR): At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm2. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD.|Baseline, 12 weeks|Full Analysis Set: All subjects with histologically confirmed diagnosis of GIST who received at least one dose of study drug.||Percentage of Participants||90% Confidence Interval|Number
687318|NCT01478373|Secondary|Time to Tumor Progression (TTP)of Patients Treated With Dovitinib|TTP: time from the date of entry into the study to first documentation of tumor progression or death due to the underlying cancer. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|9 months|Full Analysis Set: All subjects with histologically confirmed diagnosis of GIST who received at least one dose of study drug.||Days||95% Confidence Interval|Median
687319|NCT01478373|Secondary|Duration of Response or Stable Disease (SD)|Duration of response or SD: time from date of entry into study to earliest date of first objective tumor progression or death. DCR is defined as proportion of patients with best overall response of CR, PR and SD at 12 weeks according to RECIST (version 1.1). CR: Disappearance of all non-nodal target lesions. Any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm 1; PR: At least a 30% decrease in sum of diameter of all target lesions, taking as reference the baseline sum of diameters. PD: At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm2. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD.|9 months|Full Analysis Set: All subjects with histologically confirmed diagnosis of GIST who received at least one dose of study drug.||Days||Standard Deviation|Mean
687320|NCT01478373|Secondary|Time to Treatment Failure (TTF)of Patients Treated With Dovitinib|TTF: the date of entry into the study to the earliest date of the first objective tumor progression, date of death due to any cause, or date of discontinuation due to reasons other than 'Protocol deviation' or 'Administrative problems'.|9 months|Full Analysis Set: All subjects with histologically confirmed diagnosis of GIST who received at least one dose of study drug.||Days||95% Confidence Interval|Median
687321|NCT01478373|Secondary|Progression-free Survival (PFS) of Patients Treated With Dovitinib|The PFS duration: time from entry into the study to the date of the first documented progression (assessed using conventional RECIST (version 1.1) or death due to any cause. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|9 months|Full Analysis Set: All subjects with histologically confirmed diagnosis of GIST who received at least one dose of study drug.||Days||90% Confidence Interval|Median
687322|NCT01478373|Primary|Antitumor Activity of Dovitinib in Terms of Disease Control Rate (DCR): Complete Response+Partial Response +Stable Disease|DCR is defined as the proportion of patients with a best overall response of Complete Responses (CR), Partial Response (PR) and Stable Disease (SD) at 12 weeks according to RECIST (version 1.1). Complete Response (CR): Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm 1;Partial Response (PR): At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm2. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD.|12 Weeks|Full Analysis Set: all subjects with histologically confirmed diagnosis of GIST who received at least one dose of study drug.||Percentage of Participants||90% Confidence Interval|Number
687323|NCT01478360|Primary|Improvement in the Severity of Asthma as Measured by Change in the Asthma Control Questionnaire (ACQ) Score|The ACQ scores range from 0 to 6 with lower scores reflecting better asthma control. Without loss of generality, as Day 85 minus baseline (Visit 3) so that improvements in asthma control translate to negative change scores.|Baseline and 85 Days|The Pharmacodynamics (PD) analysis set was used, and subjects were analyzed according to the treatment actually. The number of patients who had evaluable PD data at the particular PD assessment time point received.||Score||90% Confidence Interval|Least Squares Mean
687324|NCT01478347|Primary|Number of Subjects (Who Had Received Two Injections of rMenB+OMV NZ Vaccine in Part I of This Study) Reporting Unsolicited Adverse Events During Safety Follow-up (Part II of the Study).|The number of subjects (who had received two injections of rMenB + OMV NZ vaccine in the part I of this study) reporting unsolicited AEs during the safety follow-up in part II of the study, are reported. Unsolicited AEs in part two of the study include – AEs considered to be related to blood draw procedure and all SAEs.|Day 92 to day 331|This analysis was done on the safety set population i.e all subjects in the exposed set with unsolicited adverse event data for part two of the study.||subjects|||Number
687325|NCT01478347|Primary|Number of Subjects Reporting Unsolicited Adverse Events, Following Vaccination With Two Injections of rMenB+OMV NZ Vaccine Between Day 1 Through Day 91.|The number of subjects with serious adverse events (SAE), medically attended adverse events and adverse events (AEs) leading to premature withdrawal, following two injections of rMenB+OMV NZ vaccine are reported.|Day 1 to day 91|This analysis was done on the safety set population i.e all subjects in the exposed set with unsolicited adverse event data for part one of the study.||subjects|||Number
687326|NCT01478256|Secondary|Evaluate Improvement of Bacterial Cultures With Two Different Topical Antibiotics|Compare improvement of microbial cultures (greater inhibition of bacterial growth) with the two antibiotics used to treat blepharitis|Three weeks|||participants|||Number
687327|NCT01478256|Primary|Improvement in Signs and Symptoms of Blepharitis|Signs and symptoms of blepharitis were scored and determined before and after treatment with two different antibiotics|Four weeks|||participants|||Number
687328|NCT01478113|Secondary|Change in Functioning on Short Form-12(SF-12)|Functional improvement: Comparison between the 2 groups of changes on the SF-12 scale at Baseline and Visit 11/Early termination visit.|Baseline to Visit 11 (which is 8 weeks of treatment) or Early Termination Visit.|not able to analyze due to small sample size|||||
687329|NCT01478113|Secondary|Change in Positive and Negative Affective Scale (PANAS)|Improvement of deficits in positive affectivity: Comparison between the 2 groups of changes on the PANAS at Baseline and Visit 11/Early Termination.|Baseline to Visit 11 (which is 8 weeks of treatment) or Early Termination Visit.|not able to analyze due to small sample size|||||
687330|NCT01478113|Secondary|Change in Behavioral Inhibition/Activation Scale (BIS/BAS)|Improvement of deficits in behavioral activation: Comparison between the 2 groups of changes on the BIS/BAS at Baseline and Visit 11/Early Termination.|Baseline to Visit 11 (which is 8 weeks of treatment) or Early Termination Visit.|not able to analyze due to small sample size|||||
687331|NCT01478113|Secondary|Change in the Snaith-Hamilton Pleasure Scale (SHAPS)|Improvement of anhedonia: Comparison between the 2 groups of changes on the SHAPS at Baseline and Visit 11/Early Termination.|Baseline to Visit 11 (which is 8 weeks of treatment) or Early Termination Visit.|not able to analyze due to small sample size|||||
687332|NCT01478113|Secondary|Change in Psychological Well-being Scale (PWB)|Well-being improvement: Comparison between the 2 groups of changes on the PWB at Baseline and Visit 11/Early Termination.|Baseline to Visit 11 (which is 8 weeks of treatment) or Early Termination Visit.|not able to analyze due to small sample size|||||
687333|NCT01478113|Primary|Change in Hamilton-Depression Rating Scale(SIGH-D)-31 Item|Comparison between the 2 groups of the percentage of participants who have responded to the treatment (response is defined here as a 50% or greater improvement on the HAM-D-31 score) between Baseline and Visit 11 or Early Termination Visit.|Baseline to Visit 11 (which is week 8 of treatment) or Early Termination Visit.|not able to analyze due to small sample size|||||
687334|NCT01478113|Primary|Change in Hamilton-Depression Rating Scale(SIGH-D)-17 Items|Comparison between the 2 groups of the percentage of subjects in remission, as defined by a HAM-D-17 score of < 8 at endpoint visit 11/week 8 of treatment, or early termination visit.|Baseline and visit 11/week 8 of treatment, or between baseline and early termination visit.|not able to analyze due to small sample size|||||
687335|NCT01478087|Primary|Rate of Device Related Serious Adverse Events (SAE) at 30 Days Post-treatment.||30 days post-treatment|||percentage of device related SAE|||Number
687336|NCT01478087|Primary|Rate of Procedure Related Serious Adverse Events (SAE) at 30 Days Post-treatment.||30 Days Post Treatment|||percentage of procedure related SAE|||Number
687337|NCT01478048|Secondary|Investigator-Assessed Objective Response Rate in Randomized Participants With at Least One FcγRIIIa V Allele|ORR was calculated for participants with a BOR of PR or better, sCR, CR, and VGPR. BOR was determined by the investigator based on myeloma tumor assessments using IMWG criteria: CR=Negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas, and < 5% plasma cells in bone marrow; sCR= CR + normal FLC ratio and absence of clonal cells in bone marrow; VGPR=Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein level + urine M-protein level < 100 mg per 24 hour; PR= ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥ 90% or to < 200 mg per 24 hour. ORR= number of participants responding divided by total number of participants randomized, measured as a percentage. Randomized participants with at least 1 FcγRIIIa V allele were a sub-set of all randomized participants.|Randomization until 111 events, up to May 2014, approximately 2 years|All randomized participants who had at least one FcγRIIIa V allele at randomization were analyzed.||percentage of participants||95% Confidence Interval|Number
687348|NCT01477853|Primary|Number of Participants Who Discontinued Study Drug Due to an Adverse Event|An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the investigational product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the investigational product, is also an adverse event. Data presented exclude data following the initiation of glycemic rescue therapy.|Up to 54 weeks|All participants as treated population included all randomized participants who received at least 1 dose of study treatment.||Participants|||Number
687338|NCT01478048|Primary|1 Year Progression-Free Survival Rate - Randomized Participants|PFS rate=Percentage probability of participants experiencing no progression or death up to 1 year, estimated using the Kaplan-Meier method. Response assessed by the investigator: Day 1 (± 7 days) of each cycle per modified IMWG criteria; assessed using ATA (ie, serum and urine M-protein tests performed within 14 days of each other; imaging done if baseline measurable extramedullary plasmacytoma existed). Progression: Any of the following: Increase of 25% from lowest response in 1 or more: serum and/or urine M-component; in those without measurable serum and urine M-protein levels, difference between involved and uninvolved FLC levels (absolute increase > 100 mg/L) ; Bone marrow plasma cell percentage (≥10%). Definite new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing lesions or plasmacytomas. Development of hypercalcemia attributed solely to the plasma cell proliferative disorder.|Year 1 after last participant was randomized|All randomized participants were analyzed.||percentage probability||95% Confidence Interval|Number
687339|NCT01478048|Secondary|Investigator-Assessed Objective Response Rate (ORR) - All Randomized Participants|ORR was calculated for participants with a best overall response (BOR) of partial response (PR) or better, including stringent complete response (sCR), complete response (CR), and very good partial response (VGPR). BOR was determined by the investigator based on myeloma tumor assessments using IMWG criteria: CR=Negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas, and < 5% plasma cells in bone marrow; sCR= CR + normal FLC ratio and absence of clonal cells in bone marrow; VGPR=Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein level + urine M-protein level < 100 mg per 24 hour; PR= ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥ 90% or to < 200 mg per 24 hour. ORR= number of participants responding divided by total number of participants randomized, measured as a percentage.|Randomization until 111 events, up to May 2014, approximately 2 years|All randomized participants were analyzed.||percentage of participants||95% Confidence Interval|Number
687340|NCT01478048|Secondary|Median Progression-free Survival Time (Months) From Randomization to Date of First Tumor Progression or Death Due to Any Cause, in Randomized Participants With at Least One FcγRIIIa V Allele|PE was planned for after at least 103 events; it was analyzed after 111 events. Response was assessed: Day 1 (± 7 days) of each cycle per modified IMWG criteria; assessed using adequate tumor assessment (ATA) (ie, serum and urine M-protein tests performed within 14 days of each other; imaging if baseline measurable extramedullary plasmacytoma existed). Progression: Any of following: Increase of 25% from lowest response in 1 or more: serum and/or urine M-component; in those without measurable serum and urine M-protein levels, difference between involved and uninvolved FLC levels (absolute increase > 100 mg/L); Bone marrow plasma cell percentage (≥10%). Definite new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing lesions or plasmacytomas. Development of hypercalcemia attributed solely to the plasma cell proliferative disorder. Randomized participants with at least 1 FcγRIIIa V allele were a sub-set of all randomized participants.|Randomization until 111 events, up to May 2014, approximately 2 years|All randomized participants who had at least one FcγRIIIa V allele were analyzed.||Months||95% Confidence Interval|Median
687341|NCT01478048|Primary|Number of Investigator-Assessed Progression-free Survival Events From Randomization to Date of First Tumor Progression or Death Due to Any Cause - All Randomized Participants|PE planned for after at least 103 events (progression/death); analyzed at 111 events. Those who neither progressed nor died were censored on the date of last adequate tumor assessment (ATA), which requires both serum and urine M-protein tests. If no post-baseline tumor assessments/no death, then censored on randomization day. Response assessed: Day 1 (± 7 days) each cycle; 30 and 60 days post treatment. Modified IMWG criteria used. Progression: Any of following: Increase of 25% in serum and/or urine M-component; if no measurable serum, urine M-protein levels, then difference between involved and uninvolved free light chain (FLC) levels (absolute increase > 100 mg/L) ; Bone marrow plasma cell percentage (≥10%). New bone lesions or soft tissue plasmacytomas or increase in size of existing lesions, plasmacytomas. Development of hypercalcemia attributed solely to plasma cell proliferative disorder. First dose occurs within 3 days of randomization.|Randomization until 111 events, up to May 2014, approximately 2 years|Intent to treat (ITT), all randomized participants were analyzed.||Events (progression or death)|||Number
687342|NCT01478048|Primary|Median Investigator-Assessed Progression-free Survival (PFS) Time (Months) From Randomization to Date of First Tumor Progression or Death Due to Any Cause - Randomized Participants|PE was planned for after at least 103 events; it was analyzed after 111 events. Response was assessed: Day 1 (± 7 days) of each cycle per modified International Myeloma Working Group (IMWG) criteria; assessed using adequate tumor assessment (ATA) (ie, serum and urine M-protein tests performed within 14 days of each other; imaging if baseline measurable extramedullary plasmacytoma existed). Progression: Any of following: Increase of 25% from lowest response in 1 or more: serum and/or urine M-component; in those without measurable serum and urine M-protein levels, difference between involved and uninvolved free light chain (FLC) levels (absolute increase > 100 mg/L); Bone marrow plasma cell percentage (≥10%). Definite new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing lesions or plasmacytomas. Development of hypercalcemia attributed solely to the plasma cell proliferative disorder.|Randomization until 111 events (disease progression or death), up to May 2014, approximately 2 years|Intent to treat (ITT), all randomized participants were analyzed.||Months||95% Confidence Interval|Median
687343|NCT01478009|Secondary|Total Number of Days of Symptoms and Duration of All Colds|Extract of Korean red ginseng intake did not significantly reduced total number of days of symptoms and duration of all colds|up to 12 weeks||||||
687344|NCT01478009|Secondary|Symptom Severity of All Colds|"Subjects received the open-ended questions about symptom severity of all colds onset during study period. The symptom severity of all colds onset was checked weekly via telephone.
Symptom severity of all colds (score 0–27) was measured during study period. The original index consists of 9 Questions(Fever, Rhinorrhea, Nasal congestion, Sore throat, Cough, Sputum, Dyspnea, Headache, Myalgia).
Individual question response is assigned a score of between 0 (none) to 3 (severe) and summed to form a total score(summed) ranging from 0 (best) to 27 (worst)."|12 weeks|per protocol analysis||Scores on a scale||Standard Deviation|Mean
687345|NCT01478009|Primary|Frequency of ILI(Influenza Like Illness)|Subjects received the open-ended questions about frequency of ILI onset during study period. The frequency of ILI onset was checked weekly via telephone.|12 weeks|per protocol analysis||participants|||Number
687346|NCT01477892|Secondary|Adverse Reaction|bradycardia, hypotension, apnea, desaturation|during and after 10min of remifentanil continous infusion|||participants|||Number
687349|NCT01477853|Primary|Number of Participants Who Experienced at Least One Adverse Event|An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the investigational product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the investigational product, is also an adverse event. Data presented exclude data following the initiation of glycemic rescue therapy.|Up to 56 weeks (including 2-week follow-up)|All participants as treated population included all randomized participants who received at least 1 dose of study treatment.||Participants|||Number
687350|NCT01477853|Secondary|Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 16|Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.|Baseline and Week 16|FAS population included all participants who took at least one dose of study medication and had baseline and at least one post-randomization observation for the analysis endpoint.||Percent change||Standard Error|Mean
687351|NCT01477853|Secondary|Percent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C) at Week 16|Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.|Baseline and Week 16|FAS population included all participants who took at least one dose of study medication and had baseline and at least one post-randomization observation for the analysis endpoint.||Percent change||Standard Error|Mean
687352|NCT01477853|Secondary|Percent Change From Baseline in Triglycerides at Week 16|Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.|Baseline and Week 16|FAS population included all participants who took at least one dose of study medication and had baseline and at least one post-randomization observation for the analysis endpoint.||Percent change||Standard Error|Mean
687353|NCT01477853|Secondary|Percent Change From Baseline in Non-high Density Lipoprotein Cholesterol (Non-HDL-C) at Week 16|Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.|Baseline and Week 16|FAS population included all participants who took at least one dose of study medication and had baseline and at least one post-randomization observation for the analysis endpoint.||Percent change||Standard Error|Mean
687354|NCT01477853|Secondary|Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 16|Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.|Baseline and Week 16|FAS population included all participants who took at least one dose of study medication and had baseline and at least one post-randomization observation for the analysis endpoint.||Percent change||Standard Error|Mean
687355|NCT01477853|Secondary|Percent Change From Baseline in Total Cholesterol at Week 16|Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.|Baseline and Week 16|FAS population included all participants who took at least one dose of study medication and had baseline and at least one post-randomization observation for the analysis endpoint.||Percent change||Standard Error|Mean
687356|NCT01477853|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 16|Change from baseline reflects the Week 16 value minus the Week 0 value.|Baseline and Week 16|FAS population included all participants who took at least one dose of study medication and had baseline and at least one post-randomization observation for the analysis endpoint.||mg/dL||Standard Error|Mean
687357|NCT01477853|Primary|Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 16|Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.|Baseline and Week 16|FAS population included all participants who took at least one dose of study medication and had baseline and at least one post-randomization observation for the analysis endpoint.||Percent change||Standard Deviation|Mean
687358|NCT01477853|Primary|Change From Baseline in Hemoglobin A1C (A1C) at Week 16|A1C is measured as percent. Thus, this change from baseline reflects the Week 16 A1C percent minus the Week 0 A1C percent.|Baseline and Week 16|Full analysis set (FAS) population included all participants who took at least one dose of study medication and had baseline and at least one post-randomization observation for the analysis endpoint.||Percent||Standard Error|Mean
687359|NCT01477762|Primary|Mean Fear-potentiated Startle to Danger Signal During Late Extinction|This measures the level of fear-potentiated startle (the difference between startle magnitude to the danger signal and baseline startle magnitude) at the end of extinction. Because the danger signal is no longer paired with the aversive stimulus like it was during the conditioning phase, the fear response should decrease from early to late extinction in individuals who show intact extinction learning.|10 hours after drug administration|||microvolts||Standard Error|Mean
687360|NCT01477762|Primary|Mean Fear-potentiated Startle to Danger Signal During Early Extinction|Fear-potentiated startle was measured as a difference score between the startle to danger signal and the baseline. This difference score reflects the degree of fear response at the beginning of extinction.|10 hours after drug administration|||microvolts||Standard Deviation|Mean
687361|NCT01477762|Primary|Mean Startle Magnitude to Danger Signal During Fear Conditioning|The acoustic startle response magnitude was measured using electromyography recordings of the eyeblink muscle when a sudden tone was delivered through headphones in the presence of a stimulus that was paired with an aversive outcome (i.e. the danger signal). If an individual showed successful fear learning, then startle to the danger signal would be greater than baseline startle.|10 hours after drug administration|||microvolts||Standard Error|Mean
687362|NCT01477762|Primary|Mean Baseline Startle Magnitude During Fear Conditioning|The study measured the acoustic startle response magnitude to a sudden noise using electromyography of the eyeblink muscle. This response magnitude was used as the individual's baseline to compare to the startle magnitude to the danger signal to see if fear conditioning had occurred.|10 hours after drug administration|||microvolts||Standard Error|Mean
687363|NCT01477749|Primary|Product Viability (Percentage)|Product viability was measured as the percentage of live PBMC in final product for infusion 1, 2, and 3 as measured by a trypan blue assay and are reported for each final product for infusion 1, 2, and 3.|Before and after culture with PAP-GM-CSF, on Day 3 (first infusion) and on approximately Days 17 and 31 (second and third infusion, respectively)|||Percentage of PBMC that are live||Full Range|Mean
687365|NCT01477749|Primary|Cumulative CD54 Upregulation|The increase in surface CD54 on APCs, expressed as an upregulation ratio of the average number of molecules on post-culture versus pre-culture cells. Cumulative CD54 upregulation = CD54 upregulation ratio for infusion 1 + CD54 upregulation ratio for infusion 2 + CD54 upregulation ratio for infusion 3.|Before and after culture with PAP-GM-CSF, on Day 3 (first infusion) and on approximately Days 17 and 31 (second and third infusion, respectively)|||Ratio||Standard Error|Mean
687366|NCT01477749|Primary|Cumulative CD54+ Cell Count|"Descriptive summarization of the cumulative sum of CD54+ counts across infusions.
Cumulative CD54 upregulation = CD54 upregulation for infusion 1 + CD54 upregulation for infusion 2 + CD54 upregulation for infusion 3"|Before and after culture with PAP-GM-CSF, on Day 3 (first infusion) and on approximately Days 17 and 31 (second and third infusion, respectively)|||10^9 cells/mL||Standard Error|Mean
687367|NCT01477710|Primary|Tidal Volume|Nurses, respiratory therapists, and physicians will provide mechanical ventilation to a test instrument using three techniques of airway management. Each participant will ventilate the model using each technique for 10 minutes, in random order. During each period, the breath-to-breath tidal volume, respiratory rate, inspiratory flow, inspiratory time, and airway pressure will be recorded.|10 minutes per technique, for a total of 30 minutes per participant|||milliliters (mL)||Standard Error|Mean
687368|NCT01477567|Secondary|Number of Participants Forming Antibody to LY3009385|The number of participants with postbaseline detection of LY3009385treatment-emergent (TE) antidrug antibodies (ADA), defined as a 4-fold increase in the ADA titer from baseline.|Baseline through Day 28|Participants who received a dose of LY3009385 or Placebo.||participants|||Number
687369|NCT01477567|Secondary|Change in Level of Glucagon Before and After a Standard Meal|The effect of LY3009385 on postprandial glucagon levels was assessed. Change from baseline glucagon concentrations 2 hours after participants started eating a standardized breakfast (mixed-meal tolerance test) were calculated and summarized by treatment arm.|Baseline, Day 14|Participants who received a dose of LY3009385 or Placebo and have evaluable glucagon concentration data. The effect of LY3009385 on postprandial glucagon concentrations was not evaluated on Day 14 for the 0.3 and 1 mg treatment arms.||picomoles per liter||Standard Deviation|Mean
687370|NCT01477567|Secondary|Change in Level of C-peptide Before and After a Standard Meal|The effect of LY3009385 on postprandial c-peptide was assessed. Change from baseline area under the c-peptide concentration-time curve from time 0 to 4 hours after participants started eating a standardized breakfast (mixed-meal tolerance test) was calculated and summarized by treatment arm.|Baseline, Day 5, and Day 14|Participants who received a dose of LY3009385 or Placebo and had evaluable c-peptide concentration data.||picomoles times hours per liter||Standard Deviation|Mean
687371|NCT01477567|Secondary|Change in Level of Blood Glucose Before and After a Standard Meal|The effect of LY3009385 on postprandial blood glucose was evaluated. Change from baseline area under the glucose concentration-time curve from time 0 to 6 hours after participants started eating a standardized breakfast (mixed-meal tolerance test) was calculated and summarized by treatment arm.|Baseline, Day 5, and Day 14|Participants who received a dose of LY3009385 or Placebo and had evaluable blood glucose concentration data.||milligrams times hours per deciliter||Standard Deviation|Mean
687372|NCT01477567|Secondary|Pharmacokinetics: Maximum Concentration (Cmax)|The maximum observed plasma concentration (Cmax) of LY3009385 is summarized.|Predose through Day 28|Participants who received a dose of LY3009385 and had evaluable LY3009385 concentration data.||nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
687373|NCT01477567|Secondary|Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3009385|LY3009385 exposure in terms of AUC from time 0 extrapolated to infinity (AUC[0-inf]) is summarized.|Predose through Day 28|Participants who received a dose of LY3009385 and had sufficient quantifiable plasma LY3009385 concentrations in the terminal phase.||micrograms times hours per milliliter||Geometric Coefficient of Variation|Geometric Mean
687374|NCT01477567|Primary|Number of Participants With One or More Drug-related Adverse Events (AEs) or Any Serious AEs|The number of participants with 1 or more AEs assessed as related to the study drug and is summarized cumulatively. In addition, the number of participants with 1 or more serious AEs is summarized cumulatively. A serious AE is defined as an event that results in death, initial or prolonged hospitalization, is life-threatening, leads to persistent or significant disability/incapacity, is associated with congenital anomaly/birth defect, or is considered significant by the investigator for any other reason. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through Day 28|All enrolled participants.||participants|||Number
687375|NCT01477463|Secondary|Incidence of Hypercalcemia for Vitamin D Toxicity|Calcium levels|2 years|||participants|||Number
687376|NCT01477463|Secondary|Vitamin D Toxicity|serum 25(OH)D for|2 years|||ng/ml||Standard Deviation|Mean
687377|NCT01477463|Primary|Number of Genes Differentialy Regulated in Melanoma That Showed Changes in Expression After Vitamin D Treatment|We utilized a prior gene expression study that compared malignant melanoma cells to benign nevi (moles) and identified over 2300 genes that were differentially regulated in melanoma compared to benign nevi. There were approximately 270 genes in our data set that showed changes in expression after vitamin D treatment. We wish to identify overlap between these two groups.|2 years|||number of genes|||Number
687378|NCT01477463|Primary|Number of Genes That Showed Changes in Expression After Vitamin D Treatment|Normal cells have a complex series of molecular signals that allow communication between cells and to the cell nucleus. These signals work together to control one or more cell functions, such as cell division or cell death. Abnormal signaling activity caused by changes in gene expression can lead to cancer. An understanding of abnormal signaling, both in the tumor and in normal tissues, may lead to new therapies in cancer patients. We wish to identify changes in molecular signaling that occur in the development of melanoma that might be suppressed in benign nevi (moles) in response to vitamin D supplementation.|2 years|All subjects treated with vitamin D3.||number of genes|||Number
687379|NCT01477450|Primary|Return of Oxygen Saturation to Baseline (Sea Level) Values|Oxygen will be titrated from either an oxygen concentrator or an oxygen cylinder in liters per minute until the oxygen saturation returns to the sea level value. The flow in liters per minute is the dependent variables. Each participant will experience induced hypoxemia followed by cylinder oxygen delivery; each will also experience induced hypoxemia followed by pulse-dose oxygen from a concentrator.|50 minutes|||participants|||Number
687380|NCT01477333|Primary|Change in Hemodynamic Parameter (Pulmonary Vascular Resistance Index) From Baseline to Week 24.|"Hemodynamics (via right heart catheterization [RHC]) were assessed at Baseline and Week 24 or at the time of premature termination of study drug if prior to the Week 24 visit.
Cardiopulmonary hemodynamic measurements included the following: pulmonary vascular resistance index (PVRI)."|Baseline and Week 24|Intent-to-treat population with data available at Baseline and Week 24.||dyn*s/cm^5*m^2||Full Range|Median
687381|NCT01477333|Primary|Change in Hemodynamic Parameter (Cardiac Index) From Baseline to Week 24.|"Hemodynamics (via right heart catheterization [RHC]) were assessed at Baseline and Week 24 or at the time of premature termination of study drug if prior to the Week 24 visit.
Cardiopulmonary hemodynamic measurements included cardiac index (CI)."|Baseline and Week 24|Intent-to-treat population with data available at Baseline and Week 24.||L/min/m^2||Full Range|Median
687382|NCT01477333|Primary|Change in Hemodynamic Parameter (Cardiac Output) From Baseline to Week 24.|Hemodynamics (via right heart catheterization [RHC]) were assessed at Baseline and Week 24 or at the time of premature termination of study drug if prior to the Week 24 visit.|Baseline and Week 24|Intent-to-treat population with data available at Baseline and Week 24.||L/min||Full Range|Median
687383|NCT01477333|Primary|Change in Hemodynamic Parameters (Arterial and Venous Oxygen Saturation) From Baseline to Week 24.|"Hemodynamics (via right heart catheterization [RHC]) were assessed at Baseline and Week 24 or at the time of premature termination of study drug if prior to the Week 24 visit.
Cardiopulmonary hemodynamic measurements included arterial oxygen saturation (SaO2) and mixed venous oxygen saturation (SvO2)."|Baseline and Week 24|Intent-to-treat population with data available at Baseline and Week 24.||percentage bound to hemoglobin||Full Range|Median
687384|NCT01477333|Primary|Change in Hemodynamic Parameter (Heart Rate) From Baseline to Week 24.|Heart rate was assessed at Baseline and Week 24 or at the time of premature termination of study drug if prior to the Week 24 visit.|Baseline and Week 24|Intent-to-treat population with data available at Baseline and Week 24.||beats/min||Full Range|Median
687385|NCT01477333|Secondary|N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP) Over the 24-week Treatment Period.|NT-proBNP was assessed at Baseline prior to starting UT-15C SR, Weeks 12 and 24, or at the time of premature termination if prior to Week 24. Blood for NT-proBNP assessment was collected before the 6MWT was conducted.|Weeks 12 and 24|Intent-to-treat population with data available at Baseline and Week 24.||pg/mL||Standard Deviation|Mean
687386|NCT01477333|Secondary|Shift From Baseline in World Health Organization (WHO) Functional Class Over the 24-week Treatment Period.|The WHO functional classification for pulmonary hypertension was assessed at Baseline prior to starting UT-15C SR, Weeks 4, 8, 12, and 24, or at the time of premature termination if prior to Week 24. The WHO functional classification ranges from I (patient's disease does not affect daily activities) to IV (patient's disease causes severe impairment).|Baseline and Weeks 4, 8, 12, and 24|Intent-to-treat population with data available at Baseline and Week 24.||participants|||Number
687387|NCT01477333|Secondary|Time to Clinical Worsening Over the Treatment Period.|Clinical worsening was assessed continuously from Baseline through each subject’s last study visit. Clinical worsening was defined as the occurrence of any one or more of the following: death (all causes), hospitalization as a result of worsening pulmonary arterial hypertension (PAH), and initiation of a parenteral prostacyclin.|Clinical worsening was assessed continuously from Baseline through each subject’s last study visit|Intent-to-treat population with data available at Baseline and Week 24.||Days||Standard Deviation|Mean
687388|NCT01477333|Secondary|Change in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Over the 24-week Treatment Period.|The 6MWT was conducted at Baseline, 2 to 4 hours after the last Tyvaso dose, and prior to first dose of UT-15C SR. The 6MWT was also performed at Weeks 4, 12, and 24, or at the time of premature termination of study drug if prior to the Week 24 visit.|Baseline and Weeks 4, 12, and 24|Intent-to-treat population with data available at Baseline and Week 24.||Meters||Full Range|Median
687389|NCT01477333|Primary|Change in Hemodynamic Parameters From Baseline to Week 24.|"Hemodynamics (via right heart catheterization [RHC]) were assessed at Baseline and Week 24 or at the time of premature termination of study drug if prior to the Week 24 visit.
Cardiopulmonary hemodynamic measurements included the following: mean pulmonary arterial pressure (PAPm), mean systemic arterial pressure (SAPm), mean right atrial pressure (RAPm), and mean pulmonary capillary wedge pressure (PCWPm)."|Baseline and Week 24|Intent-to-treat population with data available at Baseline and Week 24.||mmHg||Full Range|Median
687390|NCT01476748|Primary|Trocar Slippages With LaproStop|Number of participants with slippages with LaproStop|During the hysterectomy procedure, up to 2 hours and 32 minutes|Pilot study||Participants|||Number
687391|NCT01476748|Secondary|Trocar Slippages Without LaproStop|Number of participants with slippages with LaproStop|During the hysterectomy procedure, up to 2 hours and 32 minutes|||Participants|||Number
687392|NCT01476722|Primary|Corneal Fluorescein Staining Area at Day 30|Corneal staining was assessed by the investigator for each of five regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. The area (extent) of corneal staining for each of the five areas was estimated [i.e., 0% (no staining in the region) to 100% (staining covers entire region)], for a maximum score of 100% per eye. A lower score represents a more desirable outcome.|Day 30|Intent-to-treat. All enrolled subjects who received test article and had at least 1 on-therapy visit.||Units on a scale||Standard Deviation|Mean
687393|NCT01476722|Primary|Corneal Fluorescein Staining Area at Baseline|Corneal staining was assessed by the investigator for each of five regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. The area (extent) of corneal staining for each of the five areas was estimated [i.e., 0% (no staining in the region) to 100% (staining covers entire region)], for a maximum score of 100% per eye. A lower score represents a more desirable outcome.|Day 0 (Baseline)|Intent-to-treat. All enrolled subjects who received test article and had at least 1 on-therapy visit.||Units on a scale||Standard Deviation|Mean
687436|NCT01475955|Secondary|Stinging/Burning at Visit 6|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.|Week 12|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
708601|NCT00138125|Secondary|Duration of Response||5 years||||||
687394|NCT01476722|Primary|Corneal Fluorescein Staining Type at Day 30|Corneal staining type was assessed by the investigator for each of 5 regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. Corneal staining type was recorded on a 5-point scale for each region: 0-none; 1-micropunctate; 2-macropunctate; 3-coalesced macropunctate; 4-patch (>/= 1mm). The five regions were summed, for a maximum score of 20. A lower score represents a more desirable outcome.|Day 30|Intent-to-treat. All enrolled subjects who received test article and had at least 1 on-therapy visit.||Units on a scale||Standard Deviation|Mean
687395|NCT01476722|Primary|Corneal Fluorescein Staining Type at Baseline|Corneal staining type was assessed by the investigator for each of 5 regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. Corneal staining type was recorded on a 5-point scale for each region: 0-none; 1-micropunctate; 2-macropunctate; 3-coalesced macropunctate; 4-patch (>/= 1mm). The five regions were summed, for a maximum score of 20. A lower score represents a more desirable outcome.|Day 0 (Baseline)|Intent-to-treat. All enrolled subjects who received test article and had at least 1 on-therapy visit.||Units on a scale||Standard Deviation|Mean
687396|NCT01476696|Secondary|Number of Participants With Hemorrhagic Events Requiring Medical Intervention|Hemorrhagic events were determined by the study investigator. Medical intervention was defined as any medical attention resulting in therapy or further investigation, as determined by a trained medical professional.|Part B: Baseline up to Day 36|Participants who received at least 1 dose of prasugrel.||participants|||Number
687397|NCT01476696|Secondary|Number of Participants With Pain|"The number of participants who answered yes to the first question in the Sickle Cell Disease Pain (SCD) Questionnaire is reported. Question 1: In the past 2 weeks, did you experience any sickle cell pain?"|Part B: Baseline and Day14 ± 4 days postdose in each dosing period|Participants who responded to Question 1 of the SCD Questionnaire. A participant could be counted more than once because there were 2 dosing periods during Part B of the study.||participants|||Number
687398|NCT01476696|Secondary|Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) of Prasugrel Inactive Metabolite|AUC of prasugrel inactive metabolite(s) from time 0 up to the last sampling time of 4 hours postdose [AUC(0-tlast)]. Improvements in bioanalytical methodology enabled direct measurement of Pras-AM from plasma, obviating the need to estimate its concentration from inactive downstream metabolite(s). Thus, the AUC of prasugrel inactive metabolite(s) was not analyzed.|Part A: 0.5, 1, 1.5, 2, 4 hours postdose|No participants were analyzed.|||||
687399|NCT01476696|Primary|Percentage of Platelet Inhibition as Measured by VerifyNow™P2Y12 (VN)|Accumetrics VN assay: A point-of-care device that measures platelet aggregation. Percentage of platelet inhibition is reported by dose administered [0.03, 0.05, 0.07, 0.09, 0.11, 0.13, 0.15, 0.2, 0.25, 0.3, 0.35, 0.4, 0.45, 0.5, 0.55, and 0.6 milligrams per kilogram (mg/kg)] during Part A (single-dose range finding phase) and also during the once-daily repeated dosing phase in Part B, at steady state, 14 ± 4 days after each new dose (0.06, 0.08, and 0.12 mg/kg) is administered. One participant received the same dose at multiple visits (Part A) and one participant received the same daily dose during both dosing periods in Part B.|Part A: 4 hours postdose and Part B: at steady state (14 ± 4 days after the start of each new dosage)|Participants who received at least 1 dose of prasugrel.||percentage of platelet inhibition||Standard Deviation|Mean
687400|NCT01476696|Primary|Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) of Prasugrel Active Metabolite (Pras-AM)|AUC of Pras-AM from time 0 up to the last sampling time of 4 hours postdose [AUC(0-tlast)] is reported by dose administered [0.03, 0.05, 0.07, 0.09, 0.11, 0.13, 0.15, 0.2, 0.25, 0.3, 0.35, 0.4, 0.45, 0.5, 0.55, and 0.6 milligrams per kilogram (mg/kg)] during Part A (single-dose range finding phase) and is reported for doses administered on site (0.06, 0.08, and 0.12 mg/kg) during Part B (once-daily repeated dosing phase) of the study. Four participants received the same dose at multiple visits where pharmacokinetic samples were collected.|Parts A and B: 0.5, 1, 1.5, 2, 4 hours postdose|Participants who received at least 1 dose of prasugrel.||nanograms*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
687401|NCT01476475|Secondary|Percentage of Participants With Documented Symptomatic and Severe Symptomatic Hypoglycemia|Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L).Severe symptomatic hypoglycemia was an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. These episodes were associated with sufficient neuroglycopenia to induce seizure, unconsciousness or coma. All episodes in which neurological impairment was severe enough to prevent self-treatment and which were thought to place participants at risk for injury to themselves or others.|First dose of study drug up to 3 days after the last dose administration (maximum of 219 days)|Safety population that included all randomized participants who received at least 1 dose of study medication regardless of the amount of treatment administered.||percentage of participants|||Number
687402|NCT01476475|Secondary|Percentage of Participants Reaching HbA1c <7% With no Body Weight Gain at Week 24|Participants without any post-baseline on-treatment values (for HbA1c and body weight) that were no more than 30 days apart were counted as non-responders if at least one of the components (for HbA1c and body weight) was available and showed non-response. Otherwise, they were counted as missing data.|Week 24|mITT population. Here, number of participants analyzed = participants with any post-baseline on-treatment values (for HbA1c and body weight) that were no more than 30 days apart or with one of the components (for HbA1c and body weight) showing non-response based on the last post-baseline on-treatment value.||percentage of participants|||Number
687403|NCT01476475|Secondary|Percentage of Participants Reaching HbA1c <7% at Week 24 With no Documented Symptomatic Hypoglycemia During 24-week Treatment Period|Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L). Participants without any post-baseline on-treatment value for HbA1c were counted as non-responders if they experienced at least one documented symptomatic hypoglycemia before the introduction of rescue medication and up to 1 day after the last injection of IMP. Otherwise, they were counted as missing data. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to 14 days after the last injection of IMP.|Baseline up to Week 24|mITT population. Here, number of participants analyzed = participants with at least one post-baseline HbA1c assessment during on-treatment period.||percentage of participants|||Number
687404|NCT01476475|Secondary|Change in 30 Minute and 1-hour Plasma Glucose Excursion From Baseline to Week 24|30-minute and 1-hour plasma glucose excursion = 30-minute and 1-hour PPG minus plasma glucose value obtained 30 minutes prior to the start of the meal and before IMP administration. Change in plasma glucose excursion was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to the date of last injection of IMP.|Baseline, Week 24|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline plasma glucose excursion assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
687405|NCT01476475|Secondary|Change in 30-minute and 1-hour PPG From Baseline to Week 24|The 30 minute and 1-hour PPG test measured blood glucose 30 minutes and 1-hour after eating a standardized meal. Change in PPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to the date of last injection of IMP.|Baseline, Week 24|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline PPG assessment during on-treatment period. Here, 'n' signifies number of participants with available data for specified category.||mmol/L||Standard Error|Least Squares Mean
687406|NCT01476475|Secondary|Percentage of Participants With HbA1c ≤6.5 % or <7.0 % at Week 24|On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to 14 days after the last injection of IMP.|Week 24|mITT population. Here, number of participants analyzed = participants with at least one post-baseline HbA1c assessment during on-treatment period.||percentage of participants|||Number
687407|NCT01476475|Secondary|Percentage of Participants Requiring Rescue Therapy During 24-week Treatment Period|Routine fasting SMPG and central laboratory FPG (and HbA1c after Week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceed the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after Week 12) were performed. Threshold values from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 30: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >8%.|Baseline up to Week 24|mITT population.||percentage of participants|||Number
687408|NCT01476475|Secondary|Change in FPG From Baseline to Week 24|Change in FPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to 1 day after the last injection of IMP.|Baseline, Week 24|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline FPG assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
687409|NCT01476475|Secondary|Average Daily Insulin Glargine Dose at Week 24|Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to the date of last injection of IMP.|Week 24|mITT population. Here, number of participants analyzed = participants with insulin glargine dose measured during on-treatment period||Units (U)||Standard Error|Least Squares Mean
687410|NCT01476475|Secondary|Change in Body Weight From Baseline to Week 24|Change in body weight was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to 3 days after the last injection of IMP.|Baseline, Week 24|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline body weight assessment during on-treatment period.||kg||Standard Error|Least Squares Mean
687411|NCT01476475|Secondary|Change in Average 7-Point Self-Monitored Plasma Glucose (SMPG) Profiles From Baseline to Week 24|Participants recorded a 7-point plasma glucose profile measured before and 2-hours after each meal and at bedtime, over a single day, once in a week before baseline, before visit Week 12 and before visit Week 24 and the average value across the profiles performed in the week before a visit for the 7-time points was calculated. Change in average 7-point SMPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to the date of last injection of IMP.|Baseline, Week 24|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline 7-point SMPG assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
687412|NCT01476475|Secondary|Change in 2-hour Plasma Glucose Excursion From Baseline to Week 24|2-hour plasma glucose excursion = 2-hour PPG minus plasma glucose value obtained 30 minutes prior to the start of the meal and before IMP administration. Change in plasma glucose excursion was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to the date of last injection of IMP.|Baseline, Week 24|mITT population. Here, number of participants analyzed = participants with both baseline and at least one post-baseline plasma glucose excursion assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
687413|NCT01476475|Secondary|Change in 2-hour Postprandial Plasma Glucose (PPG) From Baseline to Week 24|The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. Change in PPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to the date of last injection of IMP.|Baseline, Week 24|mITT population.Here, number of participants analyzed = participants with both baseline and at least one post-baseline 2-hour PPG assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
687437|NCT01475955|Secondary|Stinging/Burning at Visit 5 Post PDT#2|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.|5 minutes post PDT #2|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
687414|NCT01476475|Primary|Change in HbA1c From Baseline to Week 24|Change in HbA1c was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using last observation carried forward (LOCF). On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to 14 days after the last injection of investigational medicinal product (IMP).|Baseline, Week 24|Modified intent-to-treat (mITT) population consisted of all randomized participants received at least 1 dose of IMP and had both baseline and at least 1 post-baseline efficacy assessment. Number of participants analyzed = participants with both baseline and at least one post-baseline HbA1c assessment during on-treatment period.||percentage of hemoglobin||Standard Error|Least Squares Mean
687415|NCT01476345|Secondary|Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp Procedure|Gtot is the total glucose infusion over the clamp duration and is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of LY2963016 or Lantus by adjusting the exogenous glucose infusion rate. Data presented were adjusted by the body weight.|1 hour predose up to 24 hours postdose in all treatment periods|All randomized participants who received at least 1 dose of study drug and had evaluable data to calculate Gtot. Participants were analyzed based on the treatment they received.||milligrams/kilogram (mg/kg)||Geometric Coefficient of Variation|Geometric Mean
687416|NCT01476345|Secondary|Maximum Glucose Infusion Rate (Rmax)|Rmax is the maximum infusion rate of glucose administered intravenously needed to maintain target blood glucose level and is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of LY2963016 or Lantus by adjusting the exogenous glucose infusion rate. Data presented were adjusted by the body weight.|1 hour predose up to 24 hours postdose in all treatment periods|All randomized participants who received at least 1 dose of study drug and had evaluable data to calculate Rmax. Participants were analyzed based on the treatment they received.||milligrams/kilogram/minute (mg/kg/min)||Geometric Coefficient of Variation|Geometric Mean
687417|NCT01476345|Primary|Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY2963016 and Lantus||1 hour predose up to 24 hours postdose in all treatment periods|All randomized participants who received at least 1 dose of study drug and had evaluable pharmacokinetic data to calculate Cmax. Participants were analyzed based on the treatment they received.||picomoles/Liter (pmol/L)||Geometric Coefficient of Variation|Geometric Mean
687418|NCT01476345|Primary|Pharmacokinetics: Area Under the Concentration-Time Curve From Time Zero to 24 Hours [AUC(0-24)] of LY2963016 and Lantus||1 hour predose up to 24 hours postdose in all treatment periods|All randomized participants who received at least 1 dose of study drug and had evaluable pharmacokinetic data to calculate AUC(0-24). Participants were analyzed based on the treatment they received.||picomoles*hour/Liter (pmol*h/L)||Geometric Coefficient of Variation|Geometric Mean
687419|NCT01476202|Secondary|Log Transformed Area Under the Curve of Nicotine Craving Score (AUC)|AUC between the baseline (pre-dose) and the time of measurement of craving on-treatment was determined.|Baseline, 50 seconds, 3, 5, 7, 10, 15, 20, 25, and 30 minutes post treatment administration|Intent to Treat (ITT) Population: All randomized participants who had at least one dose of medication and provided at least one craving assessment measurement on treatment. The imputation of missing craving score was based on LOCF technique.||Score on a scale*minutes||95% Confidence Interval|Log Mean
687420|NCT01476202|Primary|Mean Change From Baseline in Nicotine Craving Score on a VAS|Participants completed a nicotine craving assessment consisting of following five items: I have a desire for a cigarette right now, if it were possible I would smoke right now, All I want right now is a cigarette, I have an urge for a cigarette, I crave a cigarette right now. All participants indicated their craving intensity on a pre-drawn 100 mm scale ranging from 0 (disagree) to 100 (agree). At the end of the craving assessment period, mean VAS score was measured.|Baseline, 50 seconds, 3, 5, 7, 10, 15, 20, 25 and 30 minutes post treatment administration|Intent to Treat (ITT) Population: All randomized participants who had at least one dose of medication and provided at least one craving assessment measurement on treatment. The imputation of missing craving score was based on last observation carried forward (LOCF) technique.||Score on a scale||Standard Deviation|Mean
687421|NCT01475955|Secondary|Oozing/Vesiculation/Crusting at Visit 7|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|Week 24|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
687422|NCT01475955|Secondary|Oozing/Vesiculation/Crusting at Visit 6|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|Week 12|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
687423|NCT01475955|Secondary|Oozing/Vesiculation/Crusting at Visit 5|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|Week 8|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
687586|NCT01475071|Primary|Pain Score|Subject self assessment of pain on a scale from 0 (no pain ) to 10 (extreme pain)|Baseline (during procedure), assessed after procedure|ITT population||units on a scale||Standard Deviation|Mean
693151|NCT01419639|Primary|Change in Tumor Size From Baseline||1 Year|||% of change in tumor size from baseline|Tumors|Full Range|Median
687424|NCT01475955|Secondary|Oozing/Vesiculation/Crusting at Visit 4|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|Week 4|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
687425|NCT01475955|Secondary|Oozing/Vesiculation/Crusting at Visit 3|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|Week 2|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
687426|NCT01475955|Secondary|Oozing/Vesiculation/Crusting at Visit 2|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|24-48 hours after PDT #1|||participants|||Number
687427|NCT01475955|Secondary|Oozing/Vesiculation/Crusting at Baseline|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|Baseline|||participants|||Number
687428|NCT01475955|Secondary|Scaling and Dryness at Visit 7|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Week 24|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
687429|NCT01475955|Secondary|Scaling and Dryness at Visit 6|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Week 12|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
687430|NCT01475955|Secondary|Scaling and Dryness at Visit 5|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Week 8|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
687431|NCT01475955|Secondary|Scaling and Dryness at Visit 4|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Week 4|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
687432|NCT01475955|Secondary|Scaling and Dryness at Visit 3|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Week 2|||participants|||Number
687433|NCT01475955|Secondary|Scaling and Dryness at Visit 2|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|24-48 hours after PDT #1|||participants|||Number
687434|NCT01475955|Secondary|Scaling and Dryness at Baseline|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Baseline|||participants|||Number
687435|NCT01475955|Secondary|Stinging/Burning at Visit 7|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.|Week 24|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
687592|NCT01474993|Secondary|Red Blood Cell (RBC) Count at 4 Weeks, 18 Weeks and 22 Weeks||4 weeks, 18 weeks, 22 weeks|||*10^6 cells/µL||Standard Deviation|Mean
687438|NCT01475955|Secondary|Stinging/Burning at Visit 5 During PDT#2|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.|during PDT #2|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
687439|NCT01475955|Secondary|Stinging/Burning at Visit 5 (Pre-drug)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.|Week 8 prior to drug|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
687440|NCT01475955|Secondary|Stinging/Burning at Visit 4|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.|Week 4|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
687441|NCT01475955|Secondary|Stinging/Burning at Visit 3|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.|Week 2|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
687442|NCT01475955|Secondary|Stinging/Burning at Visit 2|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.|24-48 hours post PDT #1|||participants|||Number
687443|NCT01475955|Secondary|Stinging/Burning Post Light-Treatment|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.|5 minutes post PDT #1|||participants|||Number
687444|NCT01475955|Secondary|Stinging/Burning During Light Treatment|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.|During PDT #1 (most intense sensation)|||participants|||Number
687445|NCT01475955|Secondary|Stinging/Burning at Baseline|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.|Baseline|||participants|||Number
687446|NCT01475955|Secondary|Edema at Week 24|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Week 24|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
687447|NCT01475955|Secondary|Edema at Week 12|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Week 12|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
687448|NCT01475955|Secondary|Edema Post PDT #2|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|5 minutes post PDT #2|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
687449|NCT01475955|Secondary|Edema at Visit 5 (Pre-drug)|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Week 8 pre-drug|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
687450|NCT01475955|Secondary|Edema at Visit 4|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Week 4|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
687451|NCT01475955|Secondary|Edema at Visit 3|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Week 2|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
708602|NCT00138125|Secondary|Time to Tumor Progression||5 years||||||
687452|NCT01475955|Secondary|Edema at Visit 2|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|24-48 hours post PDT#1|||participants|||Number
687453|NCT01475955|Secondary|Edema Post-Light Treatment|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|5 minutes after PDT #1|||participants|||Number
687454|NCT01475955|Secondary|Edema at Baseline|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Baseline|||participants|||Number
687455|NCT01475955|Secondary|Erythema at Visit 7|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Week 24|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
687456|NCT01475955|Secondary|Erythema at Visit 6|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Week 12|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
687457|NCT01475955|Secondary|Erythema at Visit 5 (Post-light)|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Week 8 5 minutes post light treatment|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
687458|NCT01475955|Secondary|Erythema at Visit 5 (Pre-drug)|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Week 8 pre-drug|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
687459|NCT01475955|Secondary|Erythema at Visit 4|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Week 4|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
687460|NCT01475955|Secondary|Erythema at Visit 3|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Week 2|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
687461|NCT01475955|Secondary|Erythema at Visit 2|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|24-48 hours after PDT #1|||participants|||Number
687462|NCT01475955|Secondary|Erythema Post-Light Treatment|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|5 minutes after PDT #1|||participants|||Number
687463|NCT01475955|Secondary|Erythema at Baseline|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Baseline|||participants|||Number
687464|NCT01475955|Secondary|Hypopigmentation at Visit 7|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|Week 24|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
687465|NCT01475955|Secondary|Hypopigmentation at Visit 6|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|Week 12|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
687466|NCT01475955|Secondary|Hypopigmentation at Visit 5|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|Week 8|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
687467|NCT01475955|Secondary|Hypopigmentation at Visit 4|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|Week 4|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
687468|NCT01475955|Secondary|Hypopigmentation at Visit 3|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|Week 2|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
687469|NCT01475955|Secondary|Hypopigmentation at Visit 2|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|24-48 Hours after PDT #1|||participants|||Number
687470|NCT01475955|Secondary|Hypopigmentation at Baseline|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|Baseline|||participants|||Number
687471|NCT01475955|Secondary|Hyperpigmentation at Visit 7|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Week 24|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
687472|NCT01475955|Secondary|Hyperpigmentation at Visit 6|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Week 12|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
687473|NCT01475955|Secondary|Hyperpigmentation at Visit 5|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Week 8|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
687474|NCT01475955|Secondary|Hyperpigmentation at Visit 4|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Week 4|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
687475|NCT01475955|Secondary|Hyperpigmentation at Visit 3|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Week 2|||participants|||Number
687593|NCT01474993|Secondary|Thyroid Stimulating Hormone (TSH) at 4 Weeks, 18 Weeks and 22 Weeks||4 weeks, 18 weeks, 22 weeks|||uIU/mL||Standard Deviation|Mean
687476|NCT01475955|Secondary|Hyperpigmentation at Visit 2|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|24-48 Hours after PDT #1|||participants|||Number
687477|NCT01475955|Secondary|Hyperpigmentation at Baseline|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Baseline|||participants|||Number
687478|NCT01475955|Secondary|Subject Satisfaction Score|"0 = no improvement or worsening (not satisfied at all)
= slight improvement (slightly satisfied)
= moderate improvement (moderately satisfied)
= excellent improvement (very satisfied)"|Week 24|||participants|||Number
687479|NCT01475955|Secondary|AK Clearance Rate|"AK Clearance Rate (AKCR) for a subject is defined as:
100% x [1 - (Number of AK lesions in the Treatment Area at follow-up visit/Number of AK lesions in the Treatment Area at Baseline)]"|Baseline, Week 24|||percent clearance||Standard Deviation|Median
687480|NCT01475955|Secondary|AK Clearance Rate|"AK Clearance Rate (AKCR) for a subject is defined as:
100% x [1 - (Number of AK lesions in the Treatment Area at follow-up visit/Number of AK lesions in the Treatment Area at Baseline)]"|Baseline, Week 12|||percent clearance||Standard Deviation|Median
687481|NCT01475955|Secondary|AK Clearance Rate|"AK Clearance Rate (AKCR) for a subject is defined as:
100% x [1 - (Number of AK lesions in the Treatment Area at follow-up visit/Number of AK lesions in the Treatment Area at Baseline)]"|Baseline, Week 8|||percent clearance||Standard Deviation|Median
687482|NCT01475955|Secondary|AK Clearance Rate|"AK Clearance Rate (AKCR) for a subject is defined as:
100% x [1 - (Number of AK lesions in the Treatment Area at follow-up visit/Number of AK lesions in the Treatment Area at Baseline)]"|Baseline, Week 4|||percent clearance||Standard Deviation|Median
687483|NCT01475955|Secondary|Partial Clearance Rate|proportion of subjects with 75% or more reduction in the AK count in the Treatment Area as compared to baseline.|Baseline Week 24|||participants|||Number
687484|NCT01475955|Secondary|Partial Clearance Rate|proportion of subjects with 75% or more reduction in the AK count in the Treatment Area as compared to baseline.|Baseline, Week 12|||participants|||Number
687485|NCT01475955|Secondary|Partial Clearance Rate|proportion of subjects with 75% or more reduction in the AK count in the Treatment Area as compared to baseline.|Baseline, Week 8|||participants|||Number
687486|NCT01475955|Secondary|Partial Clearance Rate|proportion of subjects with 75% or more reduction in the AK count in the Treatment Area as compared to baseline.|Baseline, Week 4|||participants|||Number
687487|NCT01475955|Secondary|Complete Clearance Rate|the proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area|Week 24|||participants|||Number
687488|NCT01475955|Secondary|Complete Clearance Rate|The proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area|Week 8|||participants|||Number
687489|NCT01475955|Secondary|Complete Clearance Rate|The proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area|Week 4|ITT LOCF||participants|||Number
687490|NCT01475955|Primary|Complete Clearance Rate|The proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area|Week 12|Intent to Treat (ITT) with last observation carried forward (LOCF) to impute missing data||participants|||Number
687491|NCT01475851|Secondary|Number of Participants Achieving Each Indicated HBcrAg Category at Baseline,Week 24, Week 48 and Week 96|The number of participants achieving each indicated hepatitis B core-related antigen (HBcrAg) category (HBcrAg <3.0 log10, 3.0 to 4.0 log10, 4.0 to 5.0 log10, 5.0 to 6.0 log10, >=6.0 log10) (kilo units per liter [KU/L]) by study visit was summarized. The LOCF method was applied for missing values.|Baseline, Week 24, Week 48 and Week 96|FAS Population||Participants|||Number
687492|NCT01475851|Secondary|Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96|The number of participants achieving each indicated hepatitis B surface antigen (HBsAg) category (HBsAg <80, 80 to 800, 800 to 8000, 8000 to 80000, >=80000) (kilo international unit per liter [KIU/L]) by study visit was summarized.|Baseline, Week 24, Week 48 and Week 96|FAS Population||participants|||Number
687493|NCT01475851|Secondary|Number of Participants With Virological Breakthrough and Resistance-related Mutations|"The number of participants who harbored resistance-related mutations and developed virological breakthrough was summarized. Virological breakthrough defined as HBV DNA level increase >=1 log10 copies/mL above the treatment nadir were analyzed through end of treatment. Subjects who achieved the HBV-DNA values below lower limit of quantification (LLQ) (< 2.1 log10 copies/mL) in quantitative analysis at Week 96 were also considered negative in drug-resistance without implementation of genotypic analysis. Lamivudine (LAM), adefovir pivoxil (ADV), and entecavir hydrate (ETV) resistance-related mutations were analyzed at Screening (i.e. Baseline), Week 24, Week 48 and Week 96 in participants with HBV DNA level above the lower limit of detection. Virologic breakthrough was defined as 1.0 log10 or greater increases in serum HBV DNA levels from on-treatment nadir. The LOCF method was applied for missing values."|Screening, Week 24, Week 48, Week 96 and Virological Breakthrough|FAS Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).||participants|||Number
687494|NCT01475851|Secondary|Number of Participants Achieving HBsAg/HBsAb Seroconversion at Week 24, Week 48 and Week 96|The number of participants with hepatitis B surface antigen (HBsAg)/hepatitis B surface antibody (HBsAb) seroconversion at Week 24, Week 48 and Week 96 in positive HBsAg and negative HBsAb participants at Baseline were summarized. HBsAg seroconversion was defined as change of detectable antibody to HBsAg from negative to positive. The LOCF method was applied for missing values.|Week 24, Week 48 and Week 96|FAS Population||participants|||Number
687495|NCT01475851|Secondary|Number of Participants Achieving HBsAg Loss at Week 24, Week 48 and Week 96|The number of participants with hepatitis B surface antigen (HBsAg) loss at Week 24, Week 48 and Week 96 in positive HBsAg participants at Baseline were summarized. Loss of HBsAg is defined as change of detectable HBsAg from positive to negative. The LOCF method was applied for missing values.|Week 24, Week 48 and Week 96|FAS Population||participants|||Number
687496|NCT01475851|Secondary|Number of Participants With HBeAg/HBeAb Seroconversion at Week 24, Week 48 and Week 96|The number of participants achieving hepatitis Be antigen (HBeAg)/hepatitis B e antibody (HBeAb) seroconversion at Week 24, Week 48 and Week 96 in positive HBeAg and negative HBeAb participants at Baseline were summarized. Seroconversion to HBeAg is defined as change of detectable antibody to HBeAg from negative to positive. The LOCF method was applied for missing values.|Week 24, Week 48 and Week 96|FAS Population||participants|||Number
687497|NCT01475851|Secondary|Number of Participants With HBeAg Loss at Week 24, Week 48 and Week 96|The number of participants achieving hepatitis Be antigen (HBeAg) loss at Week 24, Week 48 and Week 96 in positive HBeAg participants at Baseline were summarized. Loss of HBeAg is defined as the change of detectable HBeAg from positive to negative. The LOCF method was applied for missing values.|Week 24, Week 48 and Week 96|FAS Population||participants|||Number
687498|NCT01475851|Secondary|Number of Participants With Alanine Aminotransferase (ALT) Normalization at Week 24, Week 48 and Week 96|The number of participants with alanine aminotransferase (ALT) normalization at Week 24, Week 48 and Week 96 were summarized. ALT normalization is defined as when an ALT value exceeds the upper limit of normal range (ULN) at Baseline and within the normal range at the end of treatment. The LOCF method was applied for missing values.|Week 24, Week 48 and Week 96|Biochemically Evaluable Population (BEP): all participants who received at least one dose of investigational product and with an abnormal ALT at Baseline. The population for the analysis of ALT normalization was all participants with an ALT value > ULN at Baseline.||participants|||Number
687499|NCT01475851|Secondary|Number of Participants With Serum HBV DNA < 2.1 log10 Copies/mL at Week 48 and Week 96|The number of participants with serum HBV DNA level < the lower limit of quantitation (2.1 log10 copies/mL) (i.e., the rate of suppression) at Week 48 and Week 96 were summarized. The LOCF method was applied for missing values.|Week 48 and Week 96|FAS Population.||participants|||Number
687500|NCT01475851|Secondary|Mean Change From Baseline in Serum HBV DNA Level at Week 24, Week 48 and Week 96|The mean change from Baseline in the hepatitis B virus deoxyribonucleic acid (HBV DNA) level at Week 24, Week 48 and Week 96 were assessed (HBV DNA values below the lower limit of quantitation [i.e. 2.1 log10 copies/mL] for the assay were set to the lower limit minus 0.1 [i.e. 2.0 log10 copies/mL]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Last Observation Carried Forward (LOCF) method was applied for missing values.|Baseline and Week 24, Week 48 and Week 96|FAS Population||log10 copies/mL||95% Confidence Interval|Mean
687501|NCT01475851|Primary|Number of Participants With HBV DNA Level < 2.1 log10 Copies/mL at Week 24|The number of participants with serum hepatitis B virus deoxyribonucleic acid (HBV DNA) level < the lower limit of quantitation (2.1 log10 copies/millilitres[copies/mL]) (i.e., the rate of suppression) at Week 24 was summarized. Statistical analysis was not provided for the number of participants achieving HBV DNA <2.1 log10 copies/mL (at Week 24). Missing values observed during the treatment period was imputed by the last observation carried forward (LOCF) method.|Week 24|Full Analysis Set (FAS) Population: all participants who received at least one dose of investigational product (IP) and had at least one efficacy assessment after the start of study treatment.||participants|||Number
687502|NCT01475838|Secondary|Change From Baseline in CD4+ Cell Count at Week 96||Baseline; Week 96|Participants in the Full Analysis Set with available data while on study drug were analyzed; the missing-equals-excluded approach where participants with missing data were excluded from the analysis.||cells/µL||Standard Deviation|Mean
687503|NCT01475838|Secondary|Change From Baseline in CD4+ Cell Count at Week 48||Baseline; Week 48|Participants in the Full Analysis Set with available data were analyzed; the missing-equals-excluded approach where participants with missing data were excluded from the analysis.||cells/µL||Standard Deviation|Mean
687504|NCT01475838|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96|The FDA-defined Snapshot algorithm was used, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time.|Week 96|Full Analysis Set||percentage of participants|||Number
687505|NCT01475838|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48|The FDA-defined Snapshot algorithm was used, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time.|Week 48|Full Analysis Set: Participants who were randomized and treated, and had no major eligibility criteria violations||percentage of participants|||Number
687506|NCT01475734|Secondary|Number of Participants With Any Treatment-emergent Serious Adverse Event (SAE) and Treatment-emergent Non-serious Adverse Event (AE) During the Clamp Period|Treatment-emergent AEs are defined as those with an onset on or after study drug administration. An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect.|From the time the participant consented to participate in the study through the end of the study, or the final follow-up visit for participants who discontinued active participation in the study (up to 8 study weeks)|Safety Population: all participants who received one dose of albiglutide or placebo. The Safety Population was analyzed according to treatment received.||Participants|||Number
687507|NCT01475734|Secondary|Average Albiglutide Concentration on the Day of the Clamp Procedure|Plasma samples were taken from participants at two time points on Day 4 (at 0 hours and 4 hours and 45 minutes post-dose) of Week 1 of the study for albiglutide study drug level analyses. The average concentration for each participant was calculated as the mean of the concentrations at 0 hours and 4 hours 45 minutes. The clamp procedure is a glucose-controlled insulin infusion system. Variable infusions of glucose are administered to achieve various glucose target levels. It is a way of quantifying insulin secretion and resistance.|Day 4|Albiglutide Pharmacokinetic Population: all participants who had at least one sample to compute albiglutide exposure||Nanograms per milliliter (ng/mL)||Standard Deviation|Mean
687587|NCT01475071|Primary|Lesion Response|Percent of lesions treated at Baseline, in complete response at Week 12|Week12|Only Per Protocol subjects are included in this analysis||percentage of lesions complete response||Standard Deviation|Mean
697095|NCT01370408|Secondary|Emetic Episodes|Number of emetic episodes|120 Hours|||episodes||Full Range|Mean
687508|NCT01475734|Secondary|Recovery Time of Plasma Glucose Levels to >=3.9 mmol/L (>=70 mg/dL) From the Hypoglycemic Clamp Level of 2.8 Nmol/L (50.4 mg/dL)|The effect of albiglutide and placebo on the recovery time of plasma glucose levels to >=3.9 mmol/L (7>=0 mg/dL) from the hypoglycemic clamp level of 2.8 nmol/L (50.4 mg/dL) was calculated as the time in minutes between switching off of the insulin infusion and reaching the level of >=3.9 mmol/L (>=70 mg/dL). Censored values were censored at 70 minutes. The median and 95% confidence interval data are obtained from Kaplan-Meier estimates.|Day 4|Pharmacodynamic Population||Minutes||95% Confidence Interval|Median
687509|NCT01475734|Secondary|C-peptide Values During the Glucose Clamp Period|C-peptide levels were measured at all stages of glycemia during the glucose clamp period. Epinephrine levels were measured at each clamped glucose concentration: 9 millimoles per liter (mmol/L) (0 hour [hr], 1hr, 1 hr 15 minutes [min]), 5 mmol/L (1 hr 45 min, 2 hr), 4 mmol/L (2 hr 45 min, 3 hr), 3.3 mmol/L (3 hr 30 min, 3 hr 45 min), and 2.8 mmol/L (4 hr 15 min, 4 hr 30 min), and clamp released (4 hr 45 min, 5 hr, 5 hr 15 min, 5 hr 30 min). Repeated-measures analysis of variance was performed on log-transformed pharmacodynamic parameters using a model with treatment, time, and treatment-by-time as fixed effects, and participant as a random effect. Values below the lower limit of quantification were set to the quantification limit for summary.|Day 4|Pharmacodynamic Population. Different participants may have been analyzed at different time points (reflected by n=X, X in the category titles), so the overall number of participants analyzed reflects everyone in the Pharmacodynamic Population.||Nanomoles per liter (nmol/L)||Standard Deviation|Geometric Mean
687510|NCT01475734|Secondary|Cortisol Values During the Glucose Clamp Period|Cortisol levels were measured at all stages of glycemia during the glucose clamp period. Epinephrine levels were measured at each clamped glucose concentration: 9 millimoles per liter (mmol/L) (0 hour [hr], 1hr, 1 hr 15 minutes [min]), 5 mmol/L (1 hr 45 min, 2 hr), 4 mmol/L (2 hr 45 min, 3 hr), 3.3 mmol/L (3 hr 30 min, 3 hr 45 min), and 2.8 mmol/L (4 hr 15 min, 4 hr 30 min), and clamp released (4 hr 45 min, 5 hr, 5 hr 15 min, 5 hr 30 min). Repeated-measures analysis of variance was performed on log-transformed pharmacodynamic parameters using a model with treatment, time, and treatment-by-time as fixed effects, and participant as a random effect. Values below the lower limit of quantification were set to the quantification limit for summary.|Day 4|Pharmacodynamic Population. Different participants may have been analyzed at different time points (reflected by n=X, X in the category titles), so the overall number of participants analyzed reflects everyone in the Pharmacodynamic Population.||Nanomoles per liter (nmol/L)||Standard Deviation|Geometric Mean
687511|NCT01475734|Secondary|Insulin Values During the Glucose Clamp Period|Insulin levels were measured at all stages of glycemia during the glucose clamp period. Epinephrine levels were measured at each clamped glucose concentration: 9 millimoles per liter (mmol/L) (0 hour [hr], 1hr, 1 hr 15 minutes [min]), 5 mmol/L (1 hr 45 min, 2 hr), 4 mmol/L (2 hr 45 min, 3 hr), 3.3 mmol/L (3 hr 30 min, 3 hr 45 min), and 2.8 mmol/L (4 hr 15 min, 4 hr 30 min), and clamp released (4 hr 45 min, 5 hr, 5 hr 15 min, 5 hr 30 min). Repeated-measures analysis of variance was performed on log-transformed pharmacodynamic parameters using a model with treatment, time, and treatment-by-time as fixed effects, and participant as a random effect. Values below the lower limit of quantification were set to the quantification limit for summary.|Day 4|Pharmacodynamic Population. Different participants may have been analyzed at different time points (reflected by n=X, X in the category titles), so the overall number of participants analyzed reflects everyone in the Pharmacodynamic Population.||Picomoles per liter (pmol/L)||Standard Deviation|Geometric Mean
687512|NCT01475734|Secondary|Growth Hormone Values During the Glucose Clamp Period|Growth hormone levels were measured at all stages of glycemia during the glucose clamp period. Epinephrine levels were measured at each clamped glucose concentration: 9 millimoles per liter (mmol/L) (0 hour [hr], 1hr, 1 hr 15 minutes [min]), 5 mmol/L (1 hr 45 min, 2 hr), 4 mmol/L (2 hr 45 min, 3 hr), 3.3 mmol/L (3 hr 30 min, 3 hr 45 min), and 2.8 mmol/L (4 hr 15 min, 4 hr 30 min), and clamp released (4 hr 45 min, 5 hr, 5 hr 15 min, 5 hr 30 min). Repeated-measures analysis of variance was performed on log-transformed pharmacodynamic parameters using a model with treatment, time, and treatment-by-time as fixed effects, and participant as a random effect. Values below the lower limit of quantification were set to the quantification limit for summary.|Day 4|Pharmacodynamic Population. Different participants may have been analyzed at different time points (reflected by n=X, X in the category titles), so the overall number of participants analyzed reflects everyone in the Pharmacodynamic Population.||Micrograms per liter (µg/L)||Standard Deviation|Geometric Mean
687513|NCT01475734|Secondary|Norepinephrine Values During the Glucose Clamp Period|Norepinephrine levels were measured at all stages of glycemia during the glucose clamp period. Epinephrine levels were measured at each clamped glucose concentration: 9 millimoles per liter (mmol/L) (0 hour [hr], 1hr, 1 hr 15 minutes [min]), 5 mmol/L (1 hr 45 min, 2 hr), 4 mmol/L (2 hr 45 min, 3 hr), 3.3 mmol/L (3 hr 30 min, 3 hr 45 min), and 2.8 mmol/L (4 hr 15 min, 4 hr 30 min), and clamp released (4 hr 45 min, 5 hr, 5 hr 15 min, 5 hr 30 min). Repeated-measures analysis of variance was performed on log-transformed pharmacodynamic parameters using a model with treatment, time, and treatment-by-time as fixed effects, and participant as a random effect. Values below the lower limit of quantification were set to the quantification limit for summary.|Day 4|Pharmacodynamic Population. Different participants may have been analyzed at different time points (reflected by n=X, X in the category titles), so the overall number of participants analyzed reflects everyone in the Pharmacodynamic Population.||Nanograms per liter (ng/L)||Standard Deviation|Geometric Mean
687514|NCT01475734|Secondary|Epinephrine Values During the Glucose Clamp Period|Epinephrine levels were measured at all stages of glycemia during the glucose clamp period. Epinephrine levels were measured at each clamped glucose concentration: 9 millimoles per liter (mmol/L) (0 hour [hr], 1hr, 1 hr 15 minutes [min]), 5 mmol/L (1 hr 45 min, 2 hr), 4 mmol/L (2 hr 45 min, 3 hr), 3.3 mmol/L (3 hr 30 min, 3 hr 45 min), and 2.8 mmol/L (4 hr 15 min, 4 hr 30 min), and clamp released (4 hr 45 min, 5 hr, 5 hr 15 min, 5 hr 30 min). Repeated-measures analysis of variance was performed on log-transformed pharmacodynamic parameters using a model with treatment, time, and treatment-by-time as fixed effects, and participant as a random effect. Values below the lower limit of quantification were set to the quantification limit for summary.|Day 4|Pharmacodynamic Population. Different participants may have been analyzed at different time points (reflected by n=X, X in the category titles), so the overall number of participants analyzed reflects everyone in the Pharmacodynamic Population.||Nanograms per liter (ng/L)||Standard Deviation|Geometric Mean
687588|NCT01474993|Secondary|Change From the Screening Visit in Heat Shock Protein Gene Expression (Relative Maximum Gene and Protein Expression) at 24 Hours After First Dose, 18 Weeks and 22 Weeks||Screening, 24 hours after first dose of study medication, 18 weeks, 22 weeks||||||
687515|NCT01475734|Secondary|Insulin Secretion Rate (Measured by Mathematical Analysis of C-peptide Concentrations) During the Glucose Clamp Period|The insulin secretion rate (ISR) was estimated by the deconvolution of peripheral C-peptide concentrations using a 2-compartment model that utilizes population C-peptide kinetic parameters. ISR was measured at 1 hr, 1 hr 15 min, 1 hr 45 min, 2 hr, 2 hr 45 min, 3 hr, 3 hr 30 min, 3 hr 45 min, 4 hr 15 min, and 4 hr 30 min. Repeated-measures analysis of variance was performed on insulin secretion rate using a model with treatment, time, and treatment-by-time as fixed effects, and participant as a random effect.|Day 4|Pharmacodynamic Population||Milliunits per hour (mU/hr)||Standard Deviation|Mean
687516|NCT01475734|Primary|Glucagon Concentration (Nanomoles Per Liter [Nmol/L]) During the Hypoglycemic Periods of the Glucose Clamp Procedure|Plasma glucagon levels were measured for the estimation of glucagon secretion during the hypoglycemic periods. Glucagon response was measured at each clamped glucose concentration: 9 millimoles per liter (mmol/L) (0 hour [hr], 1hr, 1 hr 15 minutes [min]), 5 mmol/L (1 hr 45 min, 2 hr), 4 mmol/L (2 hr 45 min, 3 hr), 3.3 mmol/L (3 hr 30 min, 3 hr 45 min), and 2.8 mmol/L (4 hr 15 min, 4 hr 30 min), and clamp released (4 hr 45 min, 5 hr, 5 hr 15 min, 5 hr 30 min). Repeated-measures analysis of variance was performed on non-transformed pharmacodynamic parameters using a model with treatment, time, and treatment-by-time as fixed effects, and participant as a random effect. Values below the lower limit of quantification (0.03780 nmol/L) were set to the quantification limit for summary.|Day 4|Pharmacodynamic (PD) Population: all participants who received 1 dose of albiglutide or placebo, had a Baseline assessment, and had at least 1 post-Baseline assessment of the primary endpoint (glucagon) during the clamp procedure. PD Population participants were analyzed according to randomly assigned treatment.||Nanomoles per liter (nmol/L)||Standard Deviation|Geometric Mean
687517|NCT01475721|Secondary|Mean Rescue Medication (Albuterol/Salbutamol) Use as Puffs Per 24 Hours|Rescue medication included albuterol/salbutamol used to treat acute asthma were reported as puffs per 24 hours over a period of 6 months.|From Day 1 up to 26 weeks|mITT Population. Only those participants available at specified timepoint were analysed.||Number of Puffs||Standard Error|Mean
687518|NCT01475721|Secondary|Number of Participant Withdrawals From Study Treatment Due to Asthma Exacerbation|An asthma exacerbation is defined as a deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least three days or an inpatient hospitalization or emergency department visit due to asthma that required systemic corticosteroids.|From Day 1 up to 26 weeks|mITT Population||Participants|||Number
687519|NCT01475721|Secondary|Number of Participants Experiencing at Least One Asthma Related Hospitalization , Endotracheal Intubation and Death|Hospitalization was defined as an inpatient stay or a ≥24-hour stay in an observation area in an emergency department or other equivalent facility.|From Day 1 up to 26 weeks|ITT Population||Participants|||Number
687520|NCT01475721|Primary|Number of Participants Experiencing at Least One Asthma Exacerbation|An asthma exacerbation is defined as a deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least three days or an inpatient hospitalization or emergency department visit due to asthma that required systemic corticosteroids.|From Day 1 up to 26 weeks|Modified intent to treat (mITT) Population comprised of participants included in the ITT population that correspond to each participant's period of exposure to study drug plus seven days after the last date of study drug treatment.||Participants|||Number
687521|NCT01475721|Primary|Number of Participants Experiencing an Event in the Composite Safety Endpoint of Serious Asthma Outcomes ( Asthma-related Hospitalization, Asthma-related Endotracheal Intubation, or Asthma-related Death)|Composite endpoint was defined as clinically relevant endpoint that is constructed from combinations of other clinically relevant endpoints of serious asthma outcomes (i.e., asthma-related hospitalization, asthma-related endotracheal intubation, or asthma-related death). Hospitalization was defined as an inpatient stay or a ≥24-hour stay in an observation area in an emergency department or other equivalent facility. Probability of having event was summarized with Kaplan-Meier estimates.Hazard ratio, confidence interval, and p-value are from a stratified Cox proportional hazard model, using randomization stratum as the stratification factor. The 95% CI provided in the table is actually the 95.|From Day 1 up to 26 weeks|Intent to treat (ITT) Population comprised of all participants randomized to study drug and who took study drug.||Participants|||Number
687522|NCT01475487|Secondary|Correct Landmarking|Correct landmarking by all participants between the ultrasound and digital palpation group|less than 300 seconds|||participants|||Number
687523|NCT01475487|Secondary|Number of Attempts|Number of attempts were defined as an actual attempt to cannulate trachea or layrnx of the cadavers by the participants.|not more than 300 seconds|||participants|||Number
687524|NCT01475487|Primary|The Primary Outcome Measure Was the Complication Rate Asssed as the Number of Participants Causing Injuries|The primary outcome measure was the complication rate as assessed by the severity of injuries; defined as the incidence and severity of posterior laryngeal and tracheal wall injuries, as graded by two anesthesiologists using the grading system described by Murphy et al,( none (no injury); mild (< 5 mm laceration); moderate (> 5mm laceration or partial puncture); severe (> 10 mm laceration or full puncture)).|On avergae less than 300 seconds|||Participants|||Number
687525|NCT01475487|Secondary|Insertion Time|Defined as palpation of the skin to completion of procedure- cannula in trachea.|less than 5 minutes from starting of procedure|||seconds||Standard Deviation|Mean
687526|NCT01475474|Primary|Co-primary Effectiveness Endpoint: A Relative Percentage Change in Wexner Score (or Bowel Incontinence) Severity by Comparing Post-treatment Wexner Scores to Pre-treatment (End of Baseline Period) Wexner Scores.|"The Wexner fecal incontinence scale takes into account five parameters that are scored on a scale from zero (absent) to four (daily) frequency of incontinence to gas, liquid, solid, use of pad, and quality of life. Full continence is a Wexner total of zero (0), whereas full incontinence is a Wexner total of 20.
This co-primary effectiveness endpoint is the mean % reduction in Wexner score from the baseline period to the end of the treatment period, which was calculated according to the following equation: % reduction in Wexner = 100% (baseline period Wexner - end treatment period Wexner) / (baseline period Wexner)."|Wexner score was calculated at the end of the Baseline period (Weeks 1-4) to the end of the 12-Week Treatment Period (week 16).|Primary cohort for the effectiveness analyses was the Modified Intent-To-Treat cohort which included all subjects who completed at least one week of Insert use during the 12 week Treatment Period.||Percentage change||Inter-Quartile Range|Median
687594|NCT01474993|Secondary|Renal Function Tests (Serum Creatinine) at 4 Weeks, 18 Weeks and 22 Weeks||4 weeks, 18 weeks, 22 weeks|||mg/dL||Standard Deviation|Mean
687527|NCT01475474|Primary|Co-primary Effectiveness Endpoint: A Relative Percentage Change in Episodes of Accidental Bowel Leakage (ABL) Determined by Comparing Treatment Results to Pre-treatment Results From the Baseline Period as Measured by Daily Diary Recordings.|This co-primary effectiveness endpoint was calculated as a relative percentage of the baseline Accidental Bowel Leakage (ABL) using the following equation: % reduction in ABL = 100*(baseline period ABL - treatment period ABL) / (baseline period ABL)|Reduction in accidental bowel leakage from Baseline (Weeks 1-4) through Treatment period (Weeks 5-16).|Primary cohort for the effectiveness analyses was the Modified Intent-To-Treat cohort which included all subjects who completed at least one week of Insert use during the 12 week Treatment Period.||percentage change||Inter-Quartile Range|Median
687528|NCT01475461|Secondary|Number of Participants With Abnormal Laboratory Values|Hemoglobin,hematocrit,red blood cells(RBC) count:less than [<]0.8*lower limit of normal[LLN],platelets:<0.5*LLN/greater than [>]1.75*upper limit of normal [ULN],white blood cells(WBC):<0.6*LLN or >1.5*ULN,lymphocytes,total neutrophils:<0.8*LLN or >1.2*ULN, basophils,eosinophil,monocytes:>1.2*ULN;aspartate aminotransferase,alanine aminotransferase, alkaline phosphatase:>0.3*ULN,total protein,albumin:<0.8*LLN or >1.2*ULN;total bilirubin,direct bilirubin,indirect bilirubin:>1.5*ULN;triglycerides,cholesterol:>1.3*ULN, HDL:<0.8*LLN, LDL:>1.2*ULN,blood urea nitrogen,creatinine:>1.3*ULN,uric acid:>1.2*ULN;sodium: <0.95*LLN or >1.05*ULN,potassium,chloride,calcium,bicarbonate:<0.9*LLN or >1.1*ULN;creatine kinase:>2.0*ULN;glucose:<0.6*LLN or >1.5*ULN,urine WBC and RBC:>= 20/High Power Field [HPF]),urine epithelial cells (>=1 HPF),urine bacteria >20 high-powered field;qualitative urine glucose,urine blood to Hgb ratio (>=1);urine(protein,nitrite,mucus,leukocyte >=1 in urine dipstick test).|Baseline (Day 1) up to Week 14|Safety analysis set included all randomized participants who received at least 1 dose of study treatment. Here, ‘N’ signifies participants for whom data was collected for this measure.||participants|||Number
687529|NCT01475461|Secondary|Change From Baseline in Body Weight at Week 2, 4, 8, 12 and 14||Baseline (Day 1), Week 2, 4, 8 , 12 , 14|Safety analysis set included all randomized participants who received at least 1 dose of study treatment. Here, ‘N’ signifies participants for whom data was collected for this measure and n=participants who were evaluable at given time points for each group.||kilogram (kg)||Standard Deviation|Mean
687530|NCT01475461|Secondary|Number of Hypoglycemic Events (HAE) Episodes Per Participant|A hypoglycemic event (HAE) was identified by characteristic symptoms or blood glucose levels. Median number of events per participant was reported|Baseline (Day 1) up to Week 14|Safety analysis set included all randomized participants who received at least 1 dose of study treatment. Here, ‘N’ signifies participants for whom data was collected for this measure.||events per participant||Full Range|Median
687531|NCT01475461|Secondary|Percentage of Participants With at Least 1 Hypoglycemic Events (HAE) Episode|A hypoglycemic event (HAE) was identified by characteristic symptoms or blood glucose levels. HAE is defined as 1 of the given definitions: Characteristic symptoms of HAE with no home glucose monitoring performed where clinical picture included prompt resolution with food intake, subcutaneous glucagon, or intravenous glucose; or characteristic symptoms of HAE with home glucose monitoring measurement =< 70 milligram per deciliter (mg/dL) using ACCU-CHEK plasma-referenced home glucometers or =<74 mg/dL using International Federation of Clinical Chemistry (IFCC) referenced ACCU-CHEK or central laboratory glucometers; or any laboratory glucose value, meeting the following criterion with or without accompanying symptoms: =<49 mg/dL using ACCU-CHEK plasma-referenced home glucometers or =<53 mg/dL using IFCC referenced ACCU-CHEK or central laboratory glucometers.|Baseline (Day 1) up to Week 14|Safety analysis set included all randomized participants who received at least 1 dose of study treatment. Here, ‘N’ signifies participants for whom data was collected for this measure.||percentage of participants|||Number
687532|NCT01475461|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 14 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.|Baseline (Day 1) up to 14 days after last dose (up to 101 days)|Safety analysis set included all randomized participants who received at least 1 dose of study treatment.||participants|||Number
687533|NCT01475461|Secondary|Number of Participants With Increase/Decrease From Baseline Vital Signs Data|Participants who met the criteria for increase or decrease in vital signs data were reported. Criteria for increase or decrease from baseline vital signs data: sitting systolic blood pressure (BP) of >=30 millimeter of mercury (mmHg); sitting diastolic BP of >=20 mmHg and pulse rate was based on investigator’s discretion.|Baseline (Day 1) up to Week 14|Safety analysis set included all randomized participants who received at least 1 dose of study treatment. Here, ‘N’ signifies participants for whom data was collected for this measure.||participants|||Number
687534|NCT01475461|Secondary|Number of Participants With Increase From Baseline Electrocardiogram (ECG)Data|Criteria for increase from baseline data: PR interval (percent change of greater than or equal to [>=] 25/50% [if baseline>200 then percent change of >25% counts; if baseline <=200 then percent change of >50% counts]; QRS complex (percent change of >=50%); QT Fridericia’s correction (QTcF) interval (change of >=30 to <60 millisecond [msec], and change of >=60 msec).|Baseline (Day 1) up to Week 14|Safety analysis set included all randomized participants who received at least 1 dose of study treatment. Here, ‘N’ signifies participants for whom data was collected for this measure.||participants|||Number
687535|NCT01475461|Secondary|Percentage of Participants Achieving Less Than 6.5 Percent and Less Than 7 Percent Glycosylated Hemoglobin (HbA1c) Levels at Week 12|HbA1c is a form of hemoglobin which is measured primarily to identify the average glycemic control over prolonged periods of time. The normal range for the HbA1c test, was identified as <6.5 percent by the study-specific central laboratory used and data are presented in categories of <6.5 percent and <7 percent.|Week 12|FAS: All randomized participants who received at least 1 dose of study treatment. Here, ‘N’ signifies participants for whom data was summarized for this measure.||percentage of participants|||Number
687589|NCT01474993|Secondary|Change From Screening and Baseline in Urinary Isoprostane F2α-VI Levels at 24 Hours After First Dose, at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks||Screening, baseline, 24 hours after first dose of study medication, 4 weeks, 10 weeks, 18 weeks, 22 weeks||||||
687536|NCT01475461|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8, 12 and 14||Baseline (Day 1), Week 1, 2, 4, 8, 12, 14|FAS: All randomized participants who received at least 1 dose of study treatment. Here, ‘N’ signifies participants for whom data was summarized for this measure and ‘n’ signifies participants who were evaluable at given time points for each group. Data for Week 1 had not been reported because as per protocol it was not intended to be collected.||milligram per deciliter (mg/dL)||Standard Deviation|Mean
687537|NCT01475461|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 2, 4 and 8|HbA1c is a form of hemoglobin which is measured primarily to identify the average glycemic control over prolonged periods of time. The normal range for the HbA1c test, was identified as <6.5 percent by the study-specific central laboratory used. Change from baseline in percentage of HbA1c in participants were reported.|Baseline(Day 1), Week 2, 4, 8|FAS: All randomized participants who received at least 1 dose of study treatment. Here, ‘N’ signifies participants for whom data was summarized for this measure and ‘n’ signifies participants who were evaluable at given time points for each group. Data for Week 2 had not been reported because as per protocol it was not intended to be collected.||percentage of hemoglobin||Standard Deviation|Mean
687538|NCT01475461|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 12|HbA1c is a form of hemoglobin which is measured primarily to identify the average glycemic control over prolonged periods of time. The normal range for the HbA1c test, was identified as less than (<) 6.5 percent (%) by the study-specific central laboratory used. Change from baseline in percentage of HbA1c in participants were reported.|Baseline (Day 1), Week 12|Full analysis set (FAS) included all randomized participants who received at least 1 dose of study treatment. Here, 'N' (number of participants analyzed) signifies participants for whom data was summarized for this measure and 'n' signifies participants evaluable at given time points for each group.||percentage of hemoglobin||Standard Deviation|Mean
687539|NCT01475305|Secondary|Number of Participants With Clinically Meaningful Changes From Baseline in Spirometry Values|Spirometry is a standardized assessment to evaluate lung function. Baseline values for spirometry is defined as the last measure prior to viral challenge. Spirometry assessments included percent predicted forced expiratory volume in 1 second (FEV1), FEV1/forced vital capacity (FVC), and forced expiratory flow (FEF) 25%-75% values.|Days 1, 2, 3 (Baseline), 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 31|Safety Population included all participants who received any amount of investigational product.||participants|||Number
687540|NCT01475305|Secondary|Number of Participants With Abnormalities in Laboratory Investigations Reported as Adverse Events (AEs)|Laboratory investigations included hematology, coagulation, serum chemistry and urinalysis parameters. Participants with abnormalities in these laboratory investigations recorded as AEs were reported.|From Day 1 through Day 91|Safety Population included all participants who received any amount of investigational product.||participants|||Number
687541|NCT01475305|Secondary|Number of Participants With Vital Signs Abnormalities Reported as Adverse Events (AEs)|Vital signs included temperature, respiration rate, heart rate, blood pressure. Abnormal vital sign parameters included Cardiac Disorders (Bradycardia), Respiratory, Thoracic and Mediastinal Disorders (Tachypnoea, Hyperventilation, Hypopnoea). Participants with abnormalities in these vital Signs investigations recorded as AEs were reported.|From Day 1 through Day 31|Safety Population included all participants who received any amount of investigational product.||participants|||Number
687542|NCT01475305|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and Day 360 that were absent before treatment or that worsened relative to pretreatment state.|From Day 1 (immediately following administration of study drug) to Day 360|Safety Population included all participants who received any amount of investigational product.||participants|||Number
687543|NCT01475305|Secondary|Percentage of Participants With Positive Anti-MEDI-557 Antibodies|Anti-drug antibodies in the participants blood sample were detected using a validated immunoassay. Antidrug antibodies to MEDI-557 were defined as a detectable antibody titer with a dilution value of 1:30 or greater.|Day 1 (pre-dose); Day 31, 91, 150, 180, 240, 300 and 360 post-dose|"Population for ADA included all participants who received any amount of investigational product and had >= 1 post-baseline measurement for ADA. Here, n is number of participants analysed at specific time point."||percentage of participants|||Number
687544|NCT01475305|Secondary|Area Under the Nasal Wash Concentration-Time Curve From Time Zero to Time 't' (AUC[0-t]) of MEDI-557|The AUC(0-t) is the area under the nasal wash concentration-time curve from time zero to any time 't'.|Pre-dose (Day 1) and post-dose on Days 2, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, and 31|Population for PK included all participants who received a full dose of investigational product and had >= 1 post-baseline measurement for PK.||day*nanogram per milliliter (d*ng/ml)||Standard Deviation|Mean
687545|NCT01475305|Secondary|Time to Reach Maximum Nasal Wash Concentration (Tmax) of MEDI-557|The Tmax is defined as actual sampling time to reach maximum observed MEDI-557 concentration.|Pre-dose (Day 1) and post-dose on Days 2, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, and 31|Population for PK included all participants who received a full dose of investigational product and had >= 1 post-baseline measurement for PK.||Day||Standard Deviation|Mean
687546|NCT01475305|Secondary|Maximum Nasal Wash Concentration (Cmax) of MEDI-557|The Cmax is the maximum observed nasal wash concentration of MEDI-557.|Pre-dose (Day 1) and post-dose on Days 2, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, and 31|Population for PK included all participants who received a full dose of investigational product and had >= 1 post-baseline measurement for PK.||nanogram per milliliter (ng/ml)||Standard Deviation|Mean
687547|NCT01475305|Secondary|Mean Nasal Wash Concentration of MEDI-557 at Respective Time-Points|MEDI-557 nasal wash concentrations were summarized by each sampling point [LLOQ for MEDI-557 concentration assay was 20.00 nanogram per millilitre (ng/mL) for nasal wash].|Pre-dose (Day 1) and post-dose on Days 2, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, and 31|Population for PK included all participants who received a full dose of investigational product and had >= 1 post-baseline measurement for PK.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
687590|NCT01474993|Secondary|Platelet Count at 4 Weeks, 18 Weeks and 22 Weeks||4 weeks, 18 weeks, 22 weeks|||*10^3 cells/µL||Standard Deviation|Mean
687548|NCT01475305|Secondary|Mean Clearance of MEDI-557|Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body. The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by the serum Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]).|Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360|Population for PK included all participants who received a full dose of investigational product and had >= 1 post-baseline measurement for PK.||milliliter per day (ml/d)||Standard Deviation|Mean
687549|NCT01475305|Secondary|Volume of Distribution at Steady-State (Vss) of MEDI-557|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state which is estimated by (D/AUC[0-infinity])*(AUMC[0-infinity])/AUC[0-infinity]) where D is the dose of study drug, AUMC(0-infinity) is the area under the first moment curve extrapolated to infinity and AUC(0-infinity) is the area under the serum concentration-time curve from time zero to infinite time.|Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360|Population for PK included all participants who received a full dose of investigational product and had >= 1 post-baseline measurement for PK.||milliliter (ml)||Standard Deviation|Mean
687550|NCT01475305|Secondary|Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of MEDI-557|The AUC (0-infinity) is the area under the serum concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.|Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360|Population for PK included all participants who received a full dose of investigational product and had >= 1 post-baseline measurement for PK.||d*mcg/ml||Standard Deviation|Mean
687551|NCT01475305|Secondary|Area Under the Serum Concentration-Time Curve From Time Zero to Time 't' (AUC[0-t]) of MEDI-557|The AUC(0-t) is the area under the serum concentration-time curve from time zero to any time 't'.|Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360|Population for PK included all participants who received a full dose of investigational product and had >= 1 post-baseline measurement for PK.||day*microgram per milliliter (d*mcg/ml)||Standard Deviation|Mean
687552|NCT01475305|Secondary|Serum Half Life (t1/2) of MEDI-557|Serum decay half-life is the time measured for the serum concentration to decrease by one half.|Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360|Population for PK included all participants who received a full dose of investigational product and had >= 1 post-baseline measurement for PK.||Day||Standard Deviation|Mean
687553|NCT01475305|Secondary|Time to Reach Maximum Serum Concentration (Tmax) of MEDI-557|The Tmax is defined as actual sampling time to reach maximum observed MEDI-557 concentration.|Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360|Population for PK included all participants who received a full dose of investigational product and had >= 1 post-baseline measurement for PK.||Day||Standard Deviation|Mean
687554|NCT01475305|Secondary|Maximum Serum Concentration (Cmax) of MEDI-557|The Cmax is the maximum observed serum concentration of MEDI-557.|Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360|Population for PK included all participants who received a full dose of investigational product and had >= 1 post-baseline measurement for PK.||microgram per milliliter (mcg/ml)||Standard Deviation|Mean
687555|NCT01475305|Secondary|Mean Serum MEDI-557 Concentration Through Day 360|MEDI-557 serum concentrations were summarized by each sampling point [LLOQ for MEDI-557 concentration assay was 1.56 microgram per millilitre (μg/mL) for serum].|Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360|Population for PK included all participants who received a full dose of investigational product and had >= 1 post-baseline measurement for PK. Here n = participants evaluable for specified categories, for each arm, respectively.||microgram per milliliter (ug/mL)||Standard Deviation|Mean
687556|NCT01475305|Secondary|Duration of Respiratory Syncytial Virus (RSV) Viral Shedding|Duration of viral shedding defined as the number of days from the first sample positive by any assay (that is, plaque assay culture, quantitative real-time (RT-PCR), or direct fluorescent Antibody (DFA) to the last sample positive by any assay.|From Day 5 through Day 31|Population for RSV Incidence by any Viral Assay included all participants who received both the investigational product and RSV challenge and were positive for RSV by plaque assay culture, quantitative real-time RT-PCR, or DFA.||days||Full Range|Median
687557|NCT01475305|Secondary|Mean Nasal RSV Peak as Measured by Quantitative Realtime Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)|RSV infection by plaque assay culture defined as positive sample for >= 2 consecutive days through 12 days post-RSV challenge.|From Day 5 through Day 31|Population for RSV Quantitative Real-Time RT-PCR Virology included all participants who received both the investigational product and RSV challenge and were positive for RSV-A by quantitative real-time RT-PCR (defined as positive samples for >= 2 consecutive days through 12 days post-RSV challenge).||log10 copies/mL||Standard Deviation|Mean
687558|NCT01475305|Secondary|Mean Nasal RSV Peak as Measured by Plaque Assay Culture|RSV infection by plaque assay culture defined as positive sample for >= 1 day through 12 days post-RSV challenge. log10 pfu/mL = log10 plaque-forming unit per milliliter.|From Day 5 through Day 31|Population for RSV Plaque Assay Culture Virology included all participants who received both investigational product and RSV challenge and were positive for RSV by plaque assay culture (defined as positive sample for >= 1 day through 12 days post-RSV challenge).||log10 pfu/mL||Standard Deviation|Mean
687585|NCT01475097|Primary|Subjects Experiencing Discomfort When Undergoing Peripheral Arteriography|The number of subjects experiencing overall discomfort, heat or pain between Iodixanol and Iopamidol during the diagnostic phase of imaging.|Within 10 minutes post contrast administration.|249 subjects completed assessments, for overall discomfort, heat or pain between Iodixanol and Iopamidol during the diagnostic phase of imaging.124 subjects received Iodixanol and 125 subjects received Iopamidol.||participants|||Number
687559|NCT01475305|Secondary|Mean Viral Load AUC0-t by Realtime Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)|RSV infection by plaque assay culture defined as positive sample for >= 2 consecutive days through 12 days post-RSV challenge.|From Day 5 through Day 31|Population for RSV Quantitative Real-Time RT-PCR Virology included all participants who received both the investigational product and RSV challenge and were positive for RSV-A by quantitative real-time RT-PCR (defined as positive samples for >= 2 consecutive days through 12 days post-RSV challenge).||log10 copies*day/mL||Standard Deviation|Mean
687560|NCT01475305|Secondary|Mean Viral Load AUC0-t by Plaque Assay Culture|RSV infection by plaque assay culture defined as positive sample for >= 1 day through 12 days post-RSV challenge.|From Day 5 through Day 31|Population for RSV Plaque Assay Culture Virology included all participants who received both investigational product and RSV challenge and were positive for RSV by plaque assay culture (defined as positive sample for >=1 day through 12 days post-RSV challenge).||log10 pfu*day/mL||Standard Deviation|Mean
687561|NCT01475305|Secondary|Percentage of Participants Developing Respiratory Syncytial Virus (RSV) Infection Post-RSV Challenge Measured by Quantitative Real-Time Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), Direct Fluorescent Antibody (DFA), And by Any Method|RSV infection defined as positive quantitative real-time RT-PCR (RSV-A only) sample for >= 2 consecutive days through 12 days post-RSV challenge. A sample was determined positive if log10 copies/ml >= limit of quantitation (LLOQ; 2.80 log10 copies/mL). RSV infection defined as positive DFA sample for >= 2 consecutive days through 12 days post-RSV challenge. RSV infection by any method included positive plaque assay culture sample for >=1 day through 12 days post-RSV challenge, or positive quantitative real-time RT-PCR (RSV-A only) sample for >= 2 consecutive days through 12 days post-RSV challenge, or positive DFA sample for >=2 consecutive days through 12 days post-RSV challenge.|From Day 4 to Day 15|Population for RSV Incidence included all participants who received both the investigational product and RSV challenge.||percentage of participants|||Number
687562|NCT01475305|Primary|Percentage of Participants Developing Respiratory Syncytial Virus (RSV) Infection Post-RSV Challenge Measured by Plaque Assay Culture|RSV infection is defined as positive plaque assay culture sample for greater than or equal to (>=) 1 day through 12 days post-RSV challenge. A sample was determined positive if log10 plaque-forming units per milliliter [pfu/mL] greater than or equal lower limit of quantitation (LLOQ; 1.69 log10 pfu/mL) and 2 of the 3 replicates must have greater than (>) 0 pfu/mL.|From Day 4 to Day 15|Population for RSV Incidence included all participants who received both the investigational product and RSV challenge.||percentage of participants|||Number
687563|NCT01475253|Secondary|Percentage of Participants With Change From Baseline in Cystoscopic Examination Findings|Cystoscopic examinations were performed at Baseline and Day 14. The investigator assessed the urethra and bladder for the following: visibility of ureters, stricture, erythema, presence and number of Hunner’s lesion(s) and the extent of erythema. For sites with the capability, videography or high resolution digital photographs of the bladder were taken. The findings at Day 14 were compared to the findings at Baseline and were reported as Improvement, Worsening or No Change.|Baseline, Day 14|Intent-to-treat population included all enrolled participants for whom the study insertion procedure on Baseline Randomized was initiated. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group.||percentage of participants|||Number
687564|NCT01475253|Secondary|Change From Baseline in Interstitial Cystitis Problem Index (ICPI) Score|Participants answered four questions about how bothersome their symptoms were over the past month using a 5 point scale: 1=No problem to 4=Big problem for a total possible score of 0 (best) to 16 worst). A negative change from Baseline indicates improvement.|Baseline, Days 7, 14, 28 and 42|Complete IDMC Population included all participants with available IDMC data. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group.||score on a scale||Standard Deviation|Mean
687565|NCT01475253|Secondary|Change Form Baseline in O’Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score|Participants answered four questions about bladder/voiding symptoms over the past month. 2 questions were on a scale of 0=Not at all to 5=Almost always, 1 question on a scale of 0=Not at all to 5=5 or more times per night and 1 questions from 0=Not at all to 4=Almost always for a total possible score of 0 (best) to19 (worst). A negative change from Baseline indicates improvement|Baseline, Days 7, 14, 28 and 42|Complete IDMC Population included all participants with available IDMC data. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group.||score on a scale||Standard Deviation|Mean
687566|NCT01475253|Secondary|Change From Baseline in Voiding Frequency|Participants recorded Voiding Frequency in a 72 hour voiding log at Day 7, 14, 28 and 42. Lower numbers of voiding frequency is the best. A negative change from Baseline indicates improvement.|Baseline, Days 7, 14, 28 and 42|Complete IDMC Population included all participants with available IDMC data. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group.||Voids||Standard Deviation|Mean
687567|NCT01475253|Secondary|Change From Baseline in Urinary Urgency as Assessed by VAS|Urinary urgency was defined as an immediate unstoppable urge to urinate which may be due to a sudden involuntary contraction of the muscular wall of the bladder and may be accompanied by discomfort in the bladder. Participants reported symptom of urinary urgency in the last 24 hours using a Urgency Visual Analogue Scale (VAS). The Urgency VAS consists of a 10 centimeter (cm) horizontal line with the words “No Urgency” (best) at the left end (0 cm) and the words “Urgency as bad as you can imagine” (worst) at the right end (10 cm). Participants were instructed to complete the Pain VAS by marking the spot on the line that corresponded to their urinary urgency. A negative change from Baseline indicates improvement.|Baseline, Days 7, 14, 28 and 42|Complete IDMC Population included all participants with available IDMC data. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group.||centimeters||Standard Deviation|Mean
687568|NCT01475253|Primary|Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 42|Participant reported symptom of bladder pain in the prior 24 hours using a 10 centimeter horizontal line Pain Visual Analog Scale recorded in a diary. Participants were instructed to to put a mark on the line at the point that best described their bladder pain with 0 (far left on the line) reflecting no pain and 10 (far right on the line) reflecting worse possible pain. A negative change from Baseline indicates improvement.|Baseline, Day 42|Independent Data Monitoring Committee (IDMC) Population included data reviewed by the IDMC prior to study suspension. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group.||centimeters||Standard Deviation|Mean
687569|NCT01475253|Primary|Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) ay Day 28|Participant reported symptom of bladder pain in the prior 24 hours using a 10 centimeter horizontal line Pain Visual Analog Scale recorded in a diary. Participants were instructed to to put a mark on the line at the point that best described their bladder pain with 0 (far left on the line) reflecting no pain and 10 (far right on the line) reflecting worse possible pain. A negative change from Baseline indicates improvement.|Baseline, Day 28|Independent Data Monitoring Committee (IDMC) Population included data reviewed by the IDMC prior to study suspension. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group.||centimeters||Standard Deviation|Mean
687570|NCT01475253|Primary|Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 14|Participant reported symptom of bladder pain in the prior 24 hours using a 10 centimeter horizontal line Pain Visual Analog Scale recorded in a diary. Participants were instructed to to put a mark on the line at the point that best described their bladder pain with 0 (far left on the line) reflecting no pain and 10 (far right on the line) reflecting worse possible pain. A negative change from Baseline indicates improvement.|Baseline, Day 14|Independent Data Monitoring Committee (IDMC) Population included data reviewed by the IDMC prior to study suspension. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group.||centimeters||Standard Deviation|Mean
687571|NCT01475253|Primary|Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 7|Participant reported symptom of bladder pain in the prior 24 hours using a 10 centimeter (cm) horizontal line Pain Visual Analog Scale recorded in a diary. Participants were instructed to to put a mark on the line at the point that best described their bladder pain with 0 (far left on the line) reflecting no pain and 10 (far right on the line) reflecting worse possible pain. A negative change from Baseline indicates improvement.|Baseline, Day 7|Independent Data Monitoring Committee (IDMC) Population included data reviewed by the IDMC prior to study suspension. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group.||centimeters||Standard Deviation|Mean
687572|NCT01475253|Secondary|Percentage of Responders Using the Global Response Assessment (GRA)|Participants assessed their response to treatment using a seven item scale from Markedly improved to Markedly worse. A responder was defined as a participant who rated their symptoms as either Moderately or Markedly improved.|Baseline, Days 7, 14, 28 and 42|Complete IDMC Population included all participants with available IDMC data. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group.||Percentage of Responders|||Number
687573|NCT01475214|Primary|Co-primary Aim - to Identify the Dose of KHCO3 Needed for Maximal Suppression of 24-hr Urinary Nitrogen|Describe and compare changes in 24-hour urinary nitrogen in the low and high dose and KHCO3 group and in placebo.|84 days|healthy men and women age 60 years and older||mmol/day||Standard Error|Mean
687574|NCT01475214|Primary|The Dose of Potassium Bicarbonate Needed for Maximal Suppression of 24-hr Urinary N-telopeptide|Describe and compare changes in urinary N-telopeptide (NTX) across the placebo and Potassium Bicarbonate (KHCO3) doses.|84 days|Healthy men and women age 60 years and older||nmol/day||Standard Error|Mean
687575|NCT01475175|Secondary|Electrical Conduction During Sub-maximal Exercise.|Electrical conduction will be evaluated during sub-maximal exercise by measuring the subject's intrinsic AV interval.|Time Frame: Test day visit (within 14 days of enrollment)||||||
687576|NCT01475175|Secondary|Cardiac Function With Nominal Settings During Sub-maximal Exercise.|Difference in BP-derived and echo-derived parameters of cardiac function between BiV pacing with nominal settings and intrinsic conduction during sub-maximal exercise.|Test day visit (within 14 days of enrollment)||||||
687577|NCT01475175|Secondary|Cardiac Function With aCRT Settings During Sub-maximal Exercise.|Difference in BP-derived and echocardiogram (echo)-derived parameters of cardiac function between BiV pacing with aCRT settings and BiV pacing with nominal settings during sub-maximal exercise.|Test day visit (within 14 days of enrollment)||||||
687578|NCT01475175|Secondary|Electrical Conduction at Rest.|Electrical conduction will be evaluated at rest by measuring the subject's intrinsic atrio-ventricular (AV) interval. The AV interval is the amount time between the start of atrial contraction and the start of ventricular contraction.|Test day visit (within 14 days of enrollment)||||||
687579|NCT01475175|Secondary|Cardiac Function With Nominal Settings at Rest.|Difference in BP-derived and echo-derived parameters of cardiac function between BiV pacing with nominal settings and intrinsic conduction at rest.|Test day visit (within 14 days of enrollment)||||||
687580|NCT01475175|Secondary|Cardiac Function With aCRT Settings at Rest|Difference in blood pressure (BP)-derived and echocardiogram (echo)-derived parameters of cardiac function between BiV pacing with aCRT settings and BiV pacing with nominal settings at rest.|Test day visit (within 14 days of enrollment)||||||
687581|NCT01475175|Primary|Stroke Volume During Sub-maximal Exercise.|Difference in SV between BiV pacing with aCRT settings and BiV pacing with nominal settings during sub-maximal exercise. Sub-maximal exercise is exercise performed at a level below maximum effort. The subject will perform sub-maximal exercise to achieve target heart rate close to 75% of the age-predicted maximal heart rate.|Test day visit (within 14 days of enrollment)||||||
687582|NCT01475175|Primary|Stroke Volume During Atrial Pacing.|Difference in SV between BiV pacing with aCRT settings and BiV pacing with nominal settings during atrial pacing. Atrial pacing occurs at 20 beats-per-minute (bpm) above the subject's resting heart rate.|Test day visit (within 14 days of enrollment)||||||
687583|NCT01475175|Primary|Stroke Volume at Rest|Difference in stroke volume (SV) between BiV pacing with aCRT settings and BiV pacing with nominal settings at rest. Biventricular pacing is a type of pacing that paces both the right and left ventricles of the heart. Stroke volume is the volume of blood pumped from a ventricle in one heart beat.|Test day visit (within 14 days of enrollment)||||||
687584|NCT01475097|Secondary|Comparison of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Peripheral Arteriography.|Overall Image Quality rated as ‘Excellent, Adequate or Poor’ by radiologists blinded to the contrast administration.|Within 10 minutes post contrast administration.|"A recruitment error occurred with a subject in each treatment group. Therefore, the subject's efficacy data were excluded from this efficacy analysis.
This resulted in a total of 126 Iodixanol subjects and a total 125 Iopamidol subjects were used in the imaging analysis."||participants|||Number
687591|NCT01474993|Secondary|White Blood Cell (WBC) Count at 4 Weeks, 18 Weeks and 22 Weeks||4 weeks, 18 weeks, 22 weeks|||*10^3 cells/µL||Standard Deviation|Mean
687595|NCT01474993|Secondary|Liver Function Tests [Serum Glutamic Oxaloacetic Transaminase (SGOT) and Serum Glutamic Pyruvic Transaminase (SGPT)] at 4 Weeks, 18 Weeks and 22 Weeks||4 weeks, 18 weeks, 22 weeks|||U/L||Standard Deviation|Mean
687596|NCT01474993|Secondary|Ohio Autism Clinical Impressions Scale - Improvement (OACIS-I) (or CGI-I Scores) Scores at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks|"The Ohio Autism Clinical Impressions Improvement Scale (OACIS-I) is a 10 domain scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to the baseline state at the beginning of the intervention. The 10 domains cover different aspects of patients' behavior, including global autism severity, social interaction, aberrant behavior, repetitive or ritualistic behaviors, verbal communication, non-verbal communication, hyperactivity/inattention, anxiety, sensory sensitivities and restricted/narrow interests.
Each domain is rated on a scale of 1 to 7, where “1” is very much improved; “2” is much improved; “3” is minimally improved; “4” is no change; “5” is minimally worse; “6” is much worse; or “7 is very much worse."|4 weeks, 10 weeks, 18 weeks, 22 weeks|||units on a scale||Standard Deviation|Mean
687597|NCT01474993|Secondary|Ohio Autism Clinical Global Impression Scale - Severity (OACIS-S) Scale at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks|"OACIS-S is a 10 domain scale that requires the clinician to rate the severity of the patient's autism symptoms at the time of assessment. The 10 domains cover different aspects of patients’ behavior, including global autism severity, social interaction, aberrant behavior, repetitive or ritualistic behaviors, verbal communication, non-verbal communication, hyperactivity/inattention, anxiety, sensory sensitivities and restricted/narrow interests.
Each domain is rated on a scale of 1 to 7 where 1 is normal, 2 is some symptoms sometimes affecting individual and family, 3 is mild symptoms affecting individual daily and sometimes family, 4 is moderate symptoms affecting individual and family daily, 5 is marked symptoms affecting individual daily and sometimes family, 6 is severe symptoms affecting individual daily and sometimes family, and 7 is severe symptoms affecting individual and family daily."|4 weeks, 10 weeks, 18 weeks, 22 weeks|||units on a scale||Standard Deviation|Mean
687598|NCT01474993|Secondary|Change From Screening/Baseline in Aberrant Behavior Checklist (ABC) at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks|"The Aberrant Behavior Checklist has 58 questions rated by parents or teachers on a scale of 0 to 3, where a score of 0 for particular behavior is not a problem at all, 1 indicates that the behavior is a problem but slight in degree, 2 indicates that the problem is moderately serious, and 3 indicates that the problem is severe in degree. The possible ABC scores may range from 0 to 174, where higher values represent the worse outcome.
For the purposes of this study, ABC scores were obtained at both screening (the day study participants were first seen and consent obtained) and the baseline visits (the day study medication was first started, within a month of the screening visit). The screening and baseline scores were then averaged and these average ABC scores were used to calculate the change in scores at 4 weeks, 10 weeks, 18 weeks and 22 weeks respectively."|4 weeks, 10 weeks, 18 weeks, 22 weeks|||units on a scale||Standard Deviation|Mean
687599|NCT01474993|Primary|Change From Screening/Baseline in Social Responsiveness Scale (SRS) at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks|"The Social Responsiveness Scale is a parent- and/or teacher-reported 65 question scale. Each question on the scale inquires about an observed aspect of reciprocal social behavior that is rated on the scoring sheet on a scale from 0 to 3, where 0 is best possible behavior and 3 is the worst possible behavior. The total SRS score may range from 0 to 195 where higher values represent the worse outcome.
For the purposes of this study, SRS scores were obtained at both screening (the day study participants were first seen and consent obtained) and the baseline visits (the day study medication was first started, within a month of the screening visit). The screening and baseline scores were then averaged and these average SRS scores were used to calculate the change in scores at 4 weeks, 10 weeks, 18 weeks and 22 weeks respectively."|4 weeks, 10 weeks, 18 weeks and 22 weeks|||units on a scale||Standard Deviation|Mean
687600|NCT01474915|Secondary|Post Operative Nausea and Vomiting (PONV) Scores on a Verbal Response Scale|"To assess the efficacy of triple therapy with Scopolamine, Ondansetron and Dexamethasone for prevention of post operative nausea and vomiting (PONV) in high risk patients during a delayed period after neurological surgery under general anesthesia.
- Assess the severity of nausea and vomiting during the first 24 hours after neurological surgery.
Nausea is evaluated by a standard verbal response scale (VRS) ranging from 0-10, 0 being no nausea and 10 being severe nausea. Vomiting is evaluated by the investigator or nursing staff numerically as either 0, no vomiting;, 1, mild vomiting;, 2, moderate vomiting;, or 3, severe vomiting."|24 hours post-operatively|Severity of nausea and vomiting||units on a scale||Full Range|Mean
687601|NCT01474915|Primary|Proportion of Patients With a Complete Response/Complete Control During the First 24 Hours After Neurological Surgery Under General Anesthesia|"To assess the efficacy of triple therapy with Scopolamine, Ondansetron and Dexamethasone for prevention of post operative nausea and vomiting (PONV) in high risk patients during the first 24 hours after neurological surgery under general anesthesia.
- Proportion of patients with a complete response/complete control during the first 24 hours after neurological surgery under general anesthesia.
Complete Control is defined as no emetic episode, no need for rescue medication and no more than mild nausea overall after neurological surgery and general anesthesia.
Complete Response is defined as no vomiting and no rescue therapy after neurological surgery and general anesthesia."|24 hours post operatively|Number of patients with Complete Control||participants|||Number
687602|NCT01474876|Secondary|Change in the Percentage of Psoriatic Arthritis Participants Who Have Paid Work|Working status (Working full-time, working part-time, working at home, unemployed but seeking work, work disabled, retired, student) was documented at each study visit.|Baseline (Visit 0) to 12 months|Participants with psoriatic arthritis who received adalimumab treatment||Percentage of participants|||Number
687603|NCT01474876|Primary|Percentage of Participants With Peripheral Symptoms in Remission|The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission. Remission was defined as DAS28 ≤2.6 at 12 months.|Baseline (Visit 0) to 12 months|Participants with peripheral symptoms (DAS28 > 5.1 at baseline)||Percentage of participants||95% Confidence Interval|Number
687790|NCT01474200|Secondary|EFFICACY: Total Weight Loss During the Index Hospitalization|Weight at hospital discharge minus weight at hospital admission. Negative mean values indicate weight loss.|Index Hospitalization, an average of 8 days|||lbs||Standard Deviation|Mean
687604|NCT01474876|Secondary|Mean Change in Individual Components of the Work Productivity and Activity Impairment Specific Health Problem Questionnaire in Participants With Psoriatic Arthritis|The Work Productivity and Activity Impairment (WPAI) Questionnaire is a quantitative assessment of the amount of absenteeism, presenteeism, total work productivity impairment, and total activity impairment attributable to a specific health problem (WPAI-SHP), expressed as a percentage. Participants were queried regarding their current employment status, hours missed from work because of problems associated with their PsA, hours missed from work because of any other reason, number of hours worked, how much PsA affected work productivity (0= PsA had no effect,10= PsA completely prevented me from working), and how much PsA affected ability to do regular daily activities, other than work at a job (0= PsA had no effect, 10= PsA completely prevented me from doing my daily activities) in the past 7 days.|Baseline (Visit 0) to 12 months|For presenteeism, absenteeism, and total work productivity impairment endpoints: participants with psoriatic arthritis who were employed at the time of the documentation. For the total activity impairment endpoint: participants with psoriatic arthritis who received adalimumab treatment.||Percentage change||Standard Deviation|Mean
687605|NCT01474876|Secondary|Mean Change in Health Assessment Questionnaire Disability Index ( HAQ-DI) Score (in Case of Peripheral Symptoms) or Bath Ankylosing Spondylitis Functional Index (BASFI) Score (in Case of Axial Symptoms) in Participants With Psoriatic Arthritis|"HAQ-DI consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, with a higher score representing a high-dependency disability. The minimal clinically important difference defined for the HAQ-DI is ≥0.22. HAQ-DI remission, indicating normal physical function, is defined as HAQ-DI < 0.5. The BASFI is a set of 10 questions designed to determine the degree of functional limitation in those with AS. A visual analogue scale (with 0 being easy and 10 impossible) is used. The BASFI score ranges from 0 to 10 and is derived as the mean of the single items. A higher score indicates a higher impairment of functioning."|Baseline (Visit 0) to 12 months|Participants with psoriatic arthritis with peripheral symptoms (DAS28 > 5.1 at baseline) and/or active axial symptoms (a baseline value of BASDAI > 4)||Units on a scale||Standard Deviation|Mean
687606|NCT01474876|Secondary|Predictors of Maintained Treatment Response and Remission in Participants With Psoriatic Arthritis|A mathematical technique called logistic regression was performed to identify factors that could be used to predict maintained treatment response and remission. The following baseline variables were used in the logistic regression analyses: age, gender, disease of interest, result of tuberculosis screening, time since diagnosis and extra-articular manifestations (symptoms and diseases that occur in parts of the body other than joints) at baseline. The BASDAI score at baseline was forced to serve as a predictor in each model.|Baseline (Visit 0) to 12 months|Participants with psoriatic arthritis and active axial symptoms (a baseline value of BASDAI > 4)||Odds Ratio||95% Confidence Interval|Number
687607|NCT01474876|Secondary|Correlation Between Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score (ASDAS) in Participants With Psoriatic Arthritis|BASDAI score (ranging from 0 to 10) was calculated using a questionnaire. Participants marked responses on a 10 cm visual analog scale ranging from 0 (none) to 10 (very severe) regarding fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. A positive response was defined as a 50% or more decrease in the BASDAI score at 12 months as compared to baseline. ASDAS score consists of a self-administered questionnaire plus an objective laboratory evaluation. The questionnaire covers disease activity, back pain, duration of morning stiffness and peripheral pain/swelling assessed on a visual analogue scale (from 0 to 10 cm) or on a numerical rating scale (from 0 to 10). The laboratory parameter is a measurement of C-reactive protein (mg/L) or erythrocyte sedimentation rate (mm/h). Spearman's rank correlation coefficient (CC) was calculated for BASDAI vs. ASDAS(subscript)CRP(subscript) and BASDAI vs. ASDAS(subscript)ESR(subscript).|Baseline (Visit 0) to 12 months|Participants with psoriatic arthritis and active axial symptoms (a baseline value of BASDAI > 4)||Correlation coefficient|||Number
687608|NCT01474876|Secondary|Mean Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (in Case of Axial Symptoms) and/or Disease Activity Score/28 Joints (DAS28) (in Case of Peripheral Symptoms) in Participants With Psoriatic Arthritis|"The BASDAI score was calculated using a questionnaire with 6 questions that the participants completed by marking responses on a 10-centimeter visual analog scale ranging from 0 (none) to 10 (very severe) regarding severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 to 10. A positive response was defined as a 50% or more decrease in the BASDAI score at 12 months as compared to baseline.
The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C- reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission."|Baseline (Visit 0) to 12 months|Participants with psoriatic arthritis with peripheral symptoms (DAS28 > 5.1 at baseline) and/or active axial symptoms (a baseline value of BASDAI > 4)||Units on a scale||Standard Deviation|Mean
687609|NCT01474876|Secondary|Change in the Percentage of Ankylosing Spondylitis Participants Who Have Paid Work|Working status (Working full-time, working part-time, working at home, unemployed but seeking work, work disabled, retired, student) was documented at each study visit.|Baseline (Visit 0) to 12 months|Participants with ankylosing spondylitis who received adalimumab treatment||Percentage of participants|||Number
687626|NCT01474772|Secondary|Mean Sleep Interference Rating Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|The daily sleep diary consists of an 11-point numeric rating scale with which the participant rates how painful DPN pain has interfered with their sleep during the past 24 hours. Zero indicates “does not interfere with sleep” and 10 indicates “completely interferes (unable to sleep due to pain)”. Self-assessment was performed daily in the evening before bedtime on a telephone via IVRS (time window for completion between 6.00 pm to midnight) after completion of the daily pain diary.|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.||units on a scale||Standard Error|Least Squares Mean
687610|NCT01474876|Secondary|Mean Change in Individual Components of the Work Productivity and Activity Impairment Specific Health Problem Questionnaire in Participants With Ankylosing Spondylitis|Work Productivity and Activity Impairment (WPAI) Questionnaire is a quantitative assessment of the amount of absenteeism, presenteeism, total work productivity impairment, and total activity impairment attributable to a specific health problem (WPAI-SHP), expressed as a percentage. Participants were queried regarding their current employment status, hours missed from work because of problems associated with their AS, hours missed from work because of any other reason, number of hours worked, how much AS affected work productivity (0=AS had no effect,10= AS completely prevented me from working), and how much AS affected ability to do regular daily activities, other than work at a job (0= AS had no effect, 10= AS completely prevented me from doing my daily activities) in the past 7 days.|Baseline (Visit 0) to 12 months|For presenteeism, absenteeism, and total work productivity impairment endpoints: participants with ankylosing spondylitis who were employed at the time of the documentation. For the total activity impairment endpoint: participants with ankylosing spondylitis who received adalimumab treatment.||Percentage change||Standard Deviation|Mean
687611|NCT01474876|Secondary|Percentage of Participants Whose Co-medication With Nonsteroidal Anti-inflammatory Drugs (NSAIDs) Was Stopped During the Study|Participants were surveyed at each study visit for their use of NSAID medication.|Baseline (Visit 0) to 12 months|Participants who were receiving NSAID medication at baseline||Percentage of participants|||Number
687612|NCT01474876|Secondary|Duration of Treatment With Adalimumab|The duration of treatment with adalimumab was calculated separately for participants who discontinued the medication during the study and for those who did not.|Baseline (Visit 0) to 12 months|Participants who received adalimumab treatment||Months||Standard Deviation|Mean
687613|NCT01474876|Secondary|Mean Frequency of Extra-articular Manifestations (EAMs)|Extra-articular manifestations (EAMs) are symptoms and diseases that occur in parts of the body other than joints. The number of EAMs was determined at each study visit. These included the presence of enthesitis (inflammation of ligaments and/or tendons at the site of insertion into bones), uveitis (inflammation of the middle layer of the eye), psoriasis (a skin condition that causes itchy or sore patches of thick, red skin with silvery scales), and Inflammatory bowel disease (Crohn’s disease or ulcerative colitis).|Baseline (Visit 0) to 12 months|Participants who received adalimumab treatment||Mean EAMs per participant||Standard Deviation|Mean
687614|NCT01474876|Secondary|Mean Change in Health Assessment Questionnaire Disability Index (HAQ-DI) Score (in Case of Peripheral Symptoms) or Bath Ankylosing Spondylitis Functional Index (BASFI) Score (in Case of Axial Symptoms) in Participants With Ankylosing Spondylitis|"HAQ-DI consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, with a higher score representing a high-dependency disability. The minimal clinically important difference defined for the HAQ-DI is ≥0.22. HAQ-DI remission, indicating normal physical function, is defined as HAQ-DI < 0.5. The BASFI is a set of 10 questions designed to determine the degree of functional limitation in those with AS. A visual analogue scale (with 0 being easy and 10 impossible) is used. The BASFI score ranges from 0 to 10 and is derived as the mean of the single items. A higher score indicates a higher impairment of functioning."|Baseline (Visit 0) to 12 months|Participants with ankylosing spondylitis with peripheral symptoms (DAS28 > 5.1 at baseline) and/or active axial symptoms (a baseline value of BASDAI > 4)||Units on a scale||Standard Deviation|Mean
687615|NCT01474876|Secondary|Predictors of Maintained Treatment Response and Remission in Participants With Ankylosing Spondylitis|A mathematical technique called logistic regression was performed to identify factors that could be used to predict maintained treatment response and remission. The following baseline variables were used in the logistic regression analyses: age, gender, disease of interest, result of tuberculosis screening, time since diagnosis and extra-articular manifestations (symptoms and diseases that occur in parts of the body other than joints) at baseline. The BASDAI score at baseline was forced to serve as a predictor in each model.|Baseline (Visit 0) to 12 months|Participants with ankylosing spondylitis and active axial symptoms (a baseline value of BASDAI > 4)||Odds Ratio||95% Confidence Interval|Number
687616|NCT01474876|Secondary|Correlation Between Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score (ASDAS) in Participants With Ankylosing Spondylitis|BASDAI score (ranging from 0 to 10) was calculated using a questionnaire. Participants marked responses on a 10 cm visual analog scale ranging from 0 (none) to 10 (very severe) regarding fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. A positive response was defined as a 50% or more decrease in the BASDAI score at 12 months as compared to baseline. ASDAS is a self-administered questionnaire plus an objective laboratory evaluation. The questionnaire covers disease activity, back pain, duration of morning stiffness and peripheral pain/swelling assessed on a visual analogue scale (from 0 to 10 cm) or on a numerical rating scale (from 0 to 10). The laboratory parameter is a measurement of C-reactive protein (mg/L) or erythrocyte sedimentation rate (mm/h). Spearman's rank correlation coefficient (CC) was calculated for BASDAI vs. ASDAS(subscript)CRP(subscript) and BASDAI vs. ASDAS(subscript)ESR(subscript ).|Baseline (Visit 0) to 12 months|Participants with ankylosing spondylitis and active axial symptoms (a baseline value of BASDAI > 4)||Correlation coefficient|||Number
687617|NCT01474876|Secondary|Mean Change in Ankylosing Spondylitis Disease Activity Score (ASDAS)|The ASDAS tool is a self-administered questionnaire plus an objective laboratory evaluation. The questionnaire covers disease activity, back pain, and peripheral pain/swelling assessed on a visual analogue scale (from 0 (normal) to 10 (extreme pain or disability) cm) and duration of morning stiffness on a numerical rating scale (from 0 to 10, with 0 being none and 10 representing a duration of 2 hours or longer). The laboratory parameter is a measurement of C-reactive protein (mg/L) (CRP) or erythrocyte sedimentation rate (mm/h) (ESR). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and either CRP or ESR values) are combined to yield a score ranging from 0 to no defined upper limit. Remission is defined as ASDAS score <1.3. Clinically important improvement is defined as a change ≥ 1.1 units, and major improvement is defined as a change ≥ 2.0 units.|Baseline (Visit 0) to 12 months|Participants with active axial symptoms (a baseline value of BASDAI > 4)||Units on a scale||Standard Deviation|Mean
699774|NCT00023452|Secondary|Percentage of Participants With Death Due to Any Cause||Baseline up to Month 35|Safety Population||percentage of participants|||Number
687618|NCT01474876|Secondary|Mean Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (in Case of Axial Symptoms) and/or Disease Activity Score/28 Joints (DAS28) (in Case of Peripheral Symptoms) in Participants With Ankylosing Spondylitis|"The BASDAI score was calculated using a questionnaire with 6 questions that the participants completed by marking responses on a 10-centimeter visual analog scale ranging from 0 (none) to 10 (very severe) regarding severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 to 10. A positive response was defined as a 50% or more decrease in the BASDAI score at 12 months as compared to baseline.
The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C- reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission."|Baseline (Visit 0) to 12 months|Participants with ankylosing spondylitis with peripheral symptoms (DAS28 > 5.1 at baseline) and/or active axial symptoms (a baseline value of BASDAI > 4)||Units on a scale||Standard Deviation|Mean
687619|NCT01474876|Primary|Percentage of Participants With Active Axial Symptoms in Remission|The Ankylosing Spondylitis Disease Score (ASDAS) tool is a self-administered questionnaire plus an objective laboratory evaluation. The questionnaire covers disease activity, back pain, duration of morning stiffness and peripheral pain/swelling assessed on a visual analogue scale (from 0 to 10 cm) or on a numerical rating scale (from 0 to 10). The laboratory parameter is a measurement of C-reactive protein (mg/L) or erythrocyte sedimentation rate (mm/h). Remission was defined as ASDAS <1.3 at 12 months.|Baseline (Visit 0) to 12 months|Participants with active axial symptoms (a baseline value of BASDAI > 4)||Percentage of participants||95% Confidence Interval|Number
687620|NCT01474876|Primary|Percentage of Participants With a Disease Activity Score 28 (DAS28) Decrease ≥1.2 at 12 Months Relative to Baseline|The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.|Baseline (Visit 0) to 12 months|Participants with peripheral symptoms (DAS28 > 5.1 at baseline)||Percentage of participants||95% Confidence Interval|Number
687621|NCT01474876|Primary|Percentage of Participants With a 50% or More Decrease in Bath Ankylosing Spondylitis Daily Activity Index (BASDAI) Score at 12 Months Relative to Baseline|The BASDAI score was calculated using a questionnaire with 6 questions that the participants completed by marking responses on a 10-centimeter visual analog scale ranging from 0 (none) to 10 (very severe) regarding severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 to 10. A positive response was defined as a 50% or more decrease in the BASDAI score at 12 months as compared to baseline.|Baseline (Visit 0) to 12 months|Participants with active axial symptoms (a baseline value of the BASDAI > 4).||Percentage of participants||95% Confidence Interval|Number
687622|NCT01474863|Primary|Vasopressor Dependency Index|Worst Value of Index measuring blood pressure hourly through study infusion (day 4). Vasopressor index is mean arterial blood pressure divided by catecholamine index (the catecholamine index is a dimensionless variable calculated as (dopamine dose × 1) + (dobutamine dose × 1) + (adrenaline dose × 10) + (noradrenaline × 100) + (phenylephrine dose × 100), where all doses are expressed in ug/kg/min). (Higher is better)|day 4|||mmHg/catecholamine index||Standard Deviation|Mean
687623|NCT01474772|Secondary|Euro QoL-5 Dimensions (EQ-5D) - Health State Profile Utility Scores at the End of Each Treatment Period (Week 6 of Each Treatment Period)|The EQ-5D describes participant`s health status based on 5 attributes producing an 5 digit index score. The 5 dimensions are: mobility, self-care, usual activities, pain / discomfort, and anxiety / depression. Dolan 1997 advised how to transfer this index score to a single score for clinical trials, a revised single index was published in 2001. The index uses general population weighted estimates for various health states. In general, the range of the single index tends to vary between 0 = death and 1 = perfect health and there are some states that have been rated by the general population to be worse than death which may result in numbers below 0.|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.||units on a scale||Standard Error|Least Squares Mean
687624|NCT01474772|Secondary|Hospital Anxiety and Depression Scale - Depression (HADS-D) Total Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|The HADS is a 14-item self-administered questionnaire that consists of 2 scales, one measuring anxiety (HADS-A), and the other measuring depression (HADS-D). Each subscale consists of 7 statements and the participant responds as to how each item applies to him/her over the past week on 4-point response scale. Separate scores are calculated for anxiety and depression and a score (ranging from 0 to 21) is obtained for each subscale. The higher the score, the more severe the anxiety or depression.|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.||units on a scale||Standard Error|Least Squares Mean
687625|NCT01474772|Secondary|Hospital Anxiety and Depression Scale - Anxiety (HADS-A) Total Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|The Hospital Anxiety and Depression Scale (HADS) is a 14-item self-administered questionnaire that consists of 2 scales, one measuring anxiety (HADS-A), and the other measuring depression (HADS-D). Each subscale consists of 7 statements and the participant responds as to how each item applies to him/her over the past week on 4-point response scale. Separate scores are calculated for anxiety and depression and a score (ranging from 0 to 21) is obtained for each subscale. The higher the score, the more severe the anxiety or depression.|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.||units on a scale||Standard Error|Least Squares Mean
687791|NCT01474200|Secondary|EFFICACY: Weight Loss at 72 Hours After Initiation of Treatment|Weight at 72 hours after treatment initiation minus weight at treatment initiation. Negative mean values indicate weight loss.|72 hours after treatment initiation|||lbs||Standard Deviation|Mean
687627|NCT01474772|Secondary|Percentage of Participants With Patient Global Impression of Change (PGIC) Score From Baseline at the End of Period 1 (Week 6)|The PGIC is a participant-rated instrument that measures the participant`s assessment of change in his/her overall status on a scale ranging from 1 (very much improved) to 7 (very much worse). Original scores (OS; 7 different scores) and categorized scores (CS; 4 different scores) were provided. Categorized scores were very much improved (consisting of very much improved and much improved); any improvement (consisting of very much improved, much improved, and minimally improved); no change (consisting of no change); and any worsening (consisting of minimally worse, much worse, and very much worse). Due to the crossover design, PGIC was analyzed at the end of period 1 (V6).|End of Period 1 (V6)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set. Numbers of participants analyzed are provided in section Measured Values in brackets (N: Pregabalin, Placebo).||percentage of participants|||Number
687628|NCT01474772|Secondary|Norfolk QOL-DN Autonomic Domain Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period)|"Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy. All symptoms (1 - 7) are scored as either 1 or 0, indicating presence or absence of the symptom. With the exception of questions 31 and 32, the other items are scored according to the 5-point Likert Scale (0 - 4, “no problem” to “severe problem”). In question 31, “good”, the middle item, is scored as 0, “very good” as –1, “excellent” as –2, “fair” as 1, and “poor” as 2. In question 32, “about the same”, the middle item, is scored as 0, somewhat better as –1, much better as -2, somewhat worse as 1, and much worse as 2. The autonomic domain score should be summed as follow: Σ(19, 20, 21). The scales and subscales are calculated without weighting of any kind, and reported as the integer sum of the listed questionnaire items."|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.||units on a scale||Standard Error|Least Squares Mean
687629|NCT01474772|Secondary|Norfolk QOL-DN Small Fiber Domain Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period)|"Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy. All symptoms (1 - 7) are scored as either 1 or 0, indicating presence or absence of the symptom. With the exception of questions 31 and 32, the other items are scored according to the 5-point Likert Scale (0 - 4, “no problem” to “severe problem”). In question 31, “good”, the middle item, is scored as 0, “very good” as –1, “excellent” as –2, “fair” as 1, and “poor” as 2. In question 32, “about the same”, the middle item, is scored as 0, somewhat better as –1, much better as -2, somewhat worse as 1, and much worse as 2. The small fiber domain score should be summed as follow: Σ(10, 16, 17, 18). The scales and subscales are calculated without weighting of any kind, and reported as the integer sum of the listed questionnaire items."|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.||units on a scale||Standard Error|Least Squares Mean
687630|NCT01474772|Secondary|Norfolk QOL-DN Physical Functioning / Large Fiber Domain Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period)|"Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy. All symptoms (1 - 7) are scored as either 1 or 0, indicating presence or absence of the symptom. With the exception of questions 31 and 32, the other items are scored according to the 5-point Likert Scale (0 - 4, “no problem” to “severe problem”). In question 31, “good”, the middle item, is scored as 0, “very good” as –1, “excellent” as –2, “fair” as 1, and “poor” as 2. In question 32, “about the same”, the middle item, is scored as 0, somewhat better as –1, much better as -2, somewhat worse as 1, and much worse as 2. The physical functioning / large fiber domain score should be summed as follow: Σ(8, 11, 13 - 15, 24, 27 - 35). The scales and subscales are calculated without weighting of any kind, and reported as the integer sum of the listed questionnaire items."|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.||units on a scale||Standard Error|Least Squares Mean
687631|NCT01474772|Secondary|Norfolk QOL-DN Activities of Daily Living Domain Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period)|"Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy. All symptoms (1 - 7) are scored as either 1 or 0, indicating presence or absence of the symptom. With the exception of questions 31 and 32, the other items are scored according to the 5-point Likert Scale (0 - 4, “no problem” to “severe problem”). In question 31, “good”, the middle item, is scored as 0, “very good” as –1, “excellent” as –2, “fair” as 1, and “poor” as 2. In question 32, “about the same”, the middle item, is scored as 0, somewhat better as –1, much better as -2, somewhat worse as 1, and much worse as 2. The activities of daily living domain score should be summed as follow: Σ(12, 22, 23, 25, 26). The scales and subscales are calculated without weighting of any kind, and reported as the integer sum of the listed questionnaire items."|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.||units on a scale||Standard Error|Least Squares Mean
687686|NCT01474538|Secondary|Change From Baseline in Weight|Least Squares (LS) means were adjusted for treatment, period, sequence, thiazolidinedione use (Yes/No), baseline Hemoglobin A1c (HbA1c) (>8% or ≤8%), baseline weight and participants.|Baseline, Week 16 of treatment Periods 1 and 2|All randomized participants who received at least 1 dose of study drug and had weight measured at baseline and Week 16 of Treatment Period 1 or 2. Participants were analyzed based on the treatment they received.||kilograms (kg)||Standard Error|Least Squares Mean
687982|NCT01472835|Primary|Pain Score|pain diary using 0-10 scale, with 0 being no pain and 10 being the worst pain imaginable|through 6 hours after injection|||units on a scale||Standard Deviation|Mean
687632|NCT01474772|Secondary|Norfolk QOL-DN Symptoms Domain Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period)|"Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy. All symptoms (1 - 7) are scored as either 1 or 0, indicating presence or absence of the symptom. With the exception of questions 31 and 32, the other items are scored according to the 5-point Likert Scale (0 - 4, “no problem” to “severe problem”). In question 31, “good”, the middle item, is scored as 0, “very good” as –1, “excellent” as –2, “fair” as 1, and “poor” as 2. In question 32, “about the same”, the middle item, is scored as 0, somewhat better as –1, much better as -2, somewhat worse as 1, and much worse as 2. The symptoms domain score should be summed as follow: Σ(1 - 7, 9). The scales and subscales are calculated without weighting of any kind, and reported as the integer sum of the listed questionnaire items."|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.||units on a scale||Standard Error|Least Squares Mean
687633|NCT01474772|Secondary|Norfolk Quality of Life-Diabetic Neuropathy (Norfolk QOL-DN) Total Quality of Life (TQOL) Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period)|"Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy. All symptoms (1 - 7) are scored as either 1 or 0, indicating presence or absence of the symptom. With the exception of questions 31 and 32, the other items are scored according to the 5-point Likert Scale (0 - 4, “no problem” to “severe problem”). In question 31, “good”, the middle item, is scored as 0, “very good” as –1, “excellent” as –2, “fair” as 1, and “poor” as 2. In question 32, “about the same”, the middle item, is scored as 0, somewhat better as –1, much better as -2, somewhat worse as 1, and much worse as 2. TQOL score should be summed as follow: sum (Σ) (1 - 7, 8 - 35). The scales and subscales are calculated without weighting of any kind, and reported as the integer sum of the listed questionnaire items."|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.||units on a scale||Standard Error|Least Squares Mean
687634|NCT01474772|Secondary|Walk 12 Questionnaire Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period)|The Walk-12 is a self-administered questionnaire that assesses the impact of the participant’s diabetic neuropathy over the past 2 weeks on parameters associated with walking (12 questions) based on a 5-point scale (from not at all to extremely). The total score is the sum of scores from the 12 questions, which then gets transferred to a 0-100 scale with higher scores indicating greater impairment|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.||units on a scale||Standard Error|Least Squares Mean
687635|NCT01474772|Secondary|Steps Per Day Measured by Actigraphy Over the Last 7 Days of Each Treatment Period (Week 6 of Each Treatment Period)|Actigraphy data which measured steps and daytime activity during waking hours were assessed for the last 7 days at Baseline, Visit 6, and Visit 11. The participants were instructed to wear the device on their hip during the waking hours.|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.||steps||Standard Error|Least Squares Mean
687636|NCT01474772|Secondary|Daytime Total Activity Counts Per Day Measured by Actigraphy Over the Last 7 Days of Each Treatment Period (Week 6 of Each Treatment Period)|"Actigraphy data which measured steps and daytime activity during waking hours were assessed for the last 7 days at Baseline, Visit 6, and Visit 11. Activity counts are the units of motion. It is equal to the sum of peak accelerations each second during the epoch (60 seconds). Total activity counts per day is the sum of the activity counts for each epoch (60 seconds) during the day (non-sleep period). Actigraphy was performed with an accelerometer that was worn on the hip during the waking hours. It was programmed to record movements while the device was being worn."|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.||counts||Standard Error|Least Squares Mean
687637|NCT01474772|Secondary|BPI-sf Score for Pain-Interference With Walking Ability at the End of Each Treatment Period (Week 6 of Each Treatment Period)|The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. The BPI-sf consists of 5 questions: 4 items measure pain on an 11-point scale. Scores range from 0 - 40 with higher scores indicating greater pain severity. Another item, containing 7 sub-questions, evaluates the level of interference of pain on daily functioning (general activity, walking, work ability, mood, enjoyment of life, relations with other people, and sleep) on 11-point scales (0: does not interfere; 10: completely interferes). Scores range from 0 - 70 with higher scores indicating greater interference. The sub-score pain interference with walking ability was evaluated, as it was considered to be the most relevant in the context of this study.|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.||units on a scale||Standard Error|Least Squares Mean
687650|NCT01474746|Secondary|Mullen Scales of Early Learning - Fine Motor Age-equivalent Score|The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor, visual reception, fine motor, receptive language, and expressive language. Shown here are the mean baseline age-equivalent scores from the Fine Motor scale. This scale's age-equivalent scores for each of the five scales are calculated from the raw scores for each scale, using the MSEL Age Equivalents table. Age-equivalent scores for each scale range from 0 to 70 months, with lower scores indicating that a child's fine motor skills are at a level typical of younger ages, and higher scores indicating that a child's fine motor skills are at a level typical of older ages.|At baseline visit|||months||Standard Deviation|Mean
687638|NCT01474772|Secondary|BPI-sf Score for Pain-Interference Domain at the End of Each Treatment Period (Week 6 of Each Treatment Period)|The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. The BPI-sf consists of 5 questions: 4 items measure pain (0: no pain; 10: worst pain possible) at its “worst, “least”, “average”, and “now” (current pain) on an 11-point scale. Scores range from 0 - 40 with higher scores indicating greater pain severity. Another item, containing 7 sub-questions, evaluates the level of interference of pain on daily functioning (general activity, walking, work ability, mood, enjoyment of life, relations with other people, and sleep) on 11-point scales (0: does not interfere; 10: completely interferes). Scores range from 0 - 70 with higher scores indicating greater interference.|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.||units on a scale||Standard Error|Least Squares Mean
687639|NCT01474772|Secondary|Brief Pain Inventory-Short Form (BPI-sf) Score for Pain-Severity Domain at the End of Each Treatment Period (Week 6 of Each Treatment Period)|The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. The BPI-sf consists of 5 questions: 4 items measure pain (0: no pain; 10: worst pain possible) at its “worst, “least”, “average”, and “now” (current pain) on an 11-point scale. Scores range from 0 - 40 with higher scores indicating greater pain severity. Another item, containing 7 sub-questions, evaluates the level of interference of pain on daily functioning (general activity, walking, work ability, mood, enjoyment of life, relations with other people, and sleep) on 11-point scales (0: does not interfere; 10: completely interferes). Scores range from 0 - 70 with higher scores indicating greater interference.|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.||units on a scale||Standard Error|Least Squares Mean
687640|NCT01474772|Secondary|Percentage of Participants Achieving 50% Reduction in Mean DPN Pain Score From Baseline at the End of Each Treatment Period (Week 6 of Each Treatment Period)|The daily pain diary consisted of an 11-point numeric scale ranging from 0 (“no pain”) to 10 (“worst possible pain”). Participants described their pain during the past 24 hours by having chosen the appropriate number between 0 and 10. Self-assessment was performed daily each evening before bedtime (6.00 pm to midnight) on the telephone via IVRS. The endpoint mean pain score was defined as the mean of the last 7 daily diary pain ratings while taking study medication in each treatment period - Period 1 and Period 2, respectively. A rating of 1 - 3 was considered as mild pain; 4 - 6 as moderate pain; and 7 - 10 as severe pain.|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set. Numbers of participants analyzed are provided in section Measured Values in brackets (N: Pregabalin, Placebo).||percentage of participants|||Number
687641|NCT01474772|Secondary|Percentage of Participants Achieving 30% Reduction in Mean DPN Pain Score From Baseline at the End of Each Treatment Period (Week 6 of Each Treatment Period)|The daily pain diary consisted of an 11-point numeric scale ranging from 0 (“no pain”) to 10 (“worst possible pain”). Participants described their pain during the past 24 hours by having chosen the appropriate number between 0 and 10. Self-assessment was performed daily each evening before bedtime (6.00 pm to midnight) on the telephone via IVRS. The endpoint mean pain score was defined as the mean of the last 7 daily diary pain ratings while taking study medication in each treatment period - Period 1 and Period 2, respectively. A rating of 1 - 3 was considered as mild pain; 4 - 6 as moderate pain; and 7 - 10 as severe pain.|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set. Numbers of participants analyzed are provided in section Measured Values in brackets (N: Pregabalin, Placebo).||percentage of participants|||Number
687642|NCT01474772|Primary|DPN Pain on Walking Based on a 11-point NRS of Each Treatment Period (Week 6 of Each Treatment Period)|The post-test DPN pain on walking NRS consisted of an 11-point numeric scale ranging from 0 (“no pain”) to 10 (“worst possible pain”). Participants described their DPN pain in their legs and/or feet while walking during the 50-foot walk test by choosing the appropriate number between 0 and 10. The post-test DPN pain on walking NRS was completed by the participant using paper-pen administration immediately after completing the 50-foot walk test at the end of each treatment period - Period 1 and Period 2, respectively. A rating of 1 - 3 was considered as mild pain; 4 - 6 as moderate pain; and 7 - 10 as severe pain.|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.||units on a scale||Standard Error|Least Squares Mean
687643|NCT01474772|Post-Hoc|Average Weekly DPN Pain Based on a NRS (Baseline, 6 Weeks in Period 1, 2 Weeks Washout and 6 Weeks in Period 2)|The daily pain diary consisted of an 11-point numeric scale ranging from 0 (“no pain”) to 10 (“worst possible pain”). Participants described their pain during the past 24 hours by having chosen the appropriate number between 0 and 10. Self-assessment was performed daily each evening before bedtime (6.00 pm to midnight) on the telephone via IVRS. The longitudinal mean weekly DPN pain scores were defined as the mean of 7 daily diary pain ratings. A rating of 1 - 3 was considered as mild pain; 4 - 6 as moderate pain; and 7 - 10 as severe pain.|Baseline, 6 weeks in Period 1, 2 weeks washout and 6 weeks in Period 2|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). Numbers of participants analyzed are provided in section Measured Values in brackets (N: Pregabalin, Placebo).||units on a scale||Standard Deviation|Mean
687714|NCT01474434|Secondary|Number of Participants With Adverse Events (Part A, Cohort 2)||approximately 40 days|The safety analysis set included all patients who received at least one dose of study drug.||Participants|||Number
687715|NCT01474434|Secondary|Number of Participants With Adverse Events (Part A, Cohort 1)||approximately 40 days|The safety analysis set included all patients who received at least one dose of study drug.||Participants|||Number
687644|NCT01474772|Primary|Average Diabetic Peripheral Neuropathy (DPN) Pain Based on a Numeric Rating Scale (NRS) Over the Last 7 Days of Each Treatment Period (Week 6 of Each Treatment Period)|The daily pain diary consisted of an 11-point numeric scale ranging from 0 (“no pain”) to 10 (“worst possible pain”). Participants described their pain during the past 24 hours by having chosen the appropriate number between 0 and 10. Self-assessment was performed daily each evening before bedtime (6.00 pm to midnight) on the telephone via Interactive Voice Recognition System (IVRS). The endpoint mean pain score was defined as the mean of the last 7 daily diary pain ratings while taking study medication in each treatment period - Period 1 and Period 2, respectively. A rating of 1 - 3 was considered as mild pain; 4 - 6 as moderate pain; and 7 - 10 as severe pain.|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the Intent-to-Treat (ITT) analysis (N: 203). This was the primary analysis set.||units on a scale||Standard Error|Least Squares Mean
687645|NCT01474746|Secondary|Mullen Scales of Early Learning - Summary Age-equivalent Score|The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor, visual reception, fine motor, receptive language and expressive language. Based on the raw score obtained by the participant in each scale, the scoring software computes T scores, percentile ranks, and age equivalents for each scale separately, as well as a cognitive T score sum and summary age-equivalent score to characterize overall early developmental ability. Summary age-equivalent scores range from 0 to 70 months, with lower scores indicating that a child's ability is at a level typical of younger ages, and higher scores indicating that a child's ability is at a level typical of older ages. The MSEL was administered at the baseline visit and at the 6-month follow-up visit, and mean summary age-equivalent scores at the 6-month follow-up visit for the placebo and treatment groups are shown here.|At six-month visit|Two subjects from the sertraline arm discontinued - 1 lost to follow up, 1 withdrew consent Three subjects from the placebo arm discontinued - 1 lost to follow up, 2 withdrew consent||months||Standard Deviation|Mean
687646|NCT01474746|Secondary|Mullen Scales of Early Learning - Summary Age-equivalent Score|The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor, visual reception, fine motor, receptive language and expressive language. Based on the raw score obtained by the participant in each scale, the scoring software computes T scores, percentile ranks, and age equivalents for each scale separately, as well as a cognitive T score sum and summary age-equivalent score to characterize overall early developmental ability. Summary age-equivalent scores range from 0 to 70 months, with lower scores indicating that a child's ability is at a level typical of younger ages, and higher scores indicating that a child's ability is at a level typical of older ages. The MSEL was administered at the baseline visit and at the 6-month follow-up visit, and mean baseline summary age-equivalent scores for the placebo and treatment groups are shown here.|At baseline visit|||months||Standard Deviation|Mean
687647|NCT01474746|Secondary|Mullen Scales of Early Learning - Cognitive T Score Sum|The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor (not administered because it was out of age range for most subjects), visual reception, fine motor, receptive language and expressive language. Based on the raw score obtained by the participant in each scale, the scoring software computes T scores for each scale separately. Each scale's T score has a range of 20 to 80, a mean of 50, and a standard deviation of 10, and the lower the T score, the lower the child's cognitive and developmental ability. Cognitive T score sum is the sum of the T scores for each scale administered; since 4 scales were administered, the sum's range is 80 to 320, with lower sums indicating lower overall ability. The MSEL was administered at the baseline and 6-month follow-up visits, and mean cognitive T score sums from the 6-month follow-up visit for the placebo and treatment groups are shown here.|At six-month visit|Two subjects from the sertraline arm discontinued - 1 lost to follow up, 1 withdrew consent Three subjects from the placebo arm discontinued - 1 lost to follow up, 2 withdrew consent||T scores||Standard Deviation|Mean
687648|NCT01474746|Secondary|Mullen Scales of Early Learning - Cognitive T Score Sum|The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor (not administered because it was out of age range for most subjects), visual reception, fine motor, receptive language and expressive language. Based on the raw score obtained by the participant in each scale, the scoring software computes T scores for each scale separately. Each scale's T score has a range of 20 to 80, a mean of 50, and a standard deviation of 10, and the lower the T score, the lower the child's cognitive and developmental ability. Cognitive T score sum is the sum of the T scores for each scale administered; since 4 scales were administered, the sum's range is 80 to 320, with lower sums indicating lower overall ability. The MSEL was administered at the baseline visit and at the 6-month follow-up visit, and mean baseline cognitive T score sums for the placebo and treatment groups are shown here.|At baseline visit|||T scores||Standard Deviation|Mean
687649|NCT01474746|Secondary|Mullen Scales of Early Learning - Fine Motor Age-equivalent Score|The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor, visual reception, fine motor, receptive language, and expressive language. Shown here are the mean age-equivalent scores from the Fine Motor scale at the 6-month follow-up visit. This scale's age-equivalent scores for each of the five scales are calculated from the raw scores for each scale, using the MSEL Age Equivalents table. Age-equivalent scores for each scale range from 0 to 70 months, with lower scores indicating that a child's fine motor skills are at a level typical of younger ages, and higher scores indicating that a child's fine motor skills are at a level typical of older ages.|At six-month visit|Two subjects from the sertraline arm discontinued - 1 lost to follow up, 1 withdrew consent Three subjects from the placebo arm discontinued - 1 lost to follow up, 2 withdrew consent||months||Standard Deviation|Mean
687685|NCT01474538|Secondary|Percentage of Participants With Hypoglycemic Events|A hypoglycemic episode is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia, or has blood glucose concentration of ≤ 70 milligrams/deciliter [mg/dL (3.9 millimoles/liter (mmol/L)]. The percentage of participants is the total number of participants experiencing hypoglycemic events divided by number of participants in the treatment arm multiplied by 100.|Baseline through 16 weeks of each treatment (Periods 1 and 2)|All randomized participants who received at least 1 dose of study drug. Participants were analyzed based on the treatment they received.||percentage of participants|||Number
687651|NCT01474746|Secondary|Mullen Scales of Early Learning - Fine Motor Raw Score|The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor, visual reception, fine motor, receptive language, and expressive language. Shown here are the mean raw scores from the Fine Motor scale at the 6-month follow-up visit. This scale's raw scores range from 0 to 49. The lower the score on this scale, the weaker the child's fine motor skills; the higher the score, the greater the child's fine motor skills.|At six-month visit|Two subjects from the sertraline arm discontinued - 1 lost to follow up, 1 withdrew consent Three subjects from the placebo arm discontinued - 1 lost to follow up, 2 withdrew consent||units on a scale||Standard Deviation|Mean
687652|NCT01474746|Secondary|Mullen Scales of Early Learning - Visual Reception Age-equivalent Score|The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor, visual reception, fine motor, receptive language, and expressive language. Shown here are the mean age-equivalent scores from the Visual Reception scale at the 6-month follow-up visit. This scale's age-equivalent scores for each of the five scales are calculated from the raw scores for each scale, using the MSEL Age Equivalents table. Age-equivalent scores for each scale range from 0 to 70 months, with lower scores indicating that a child's visual reception is at a level typical of younger ages, and higher scores indicating that a child's visual reception is at a level typical of older ages.|At six-month visit|Two subjects from the sertraline arm discontinued - 1 lost to follow up, 1 withdrew consent Three subjects from the placebo arm discontinued - 1 lost to follow up, 2 withdrew consent||months||Standard Deviation|Mean
687653|NCT01474746|Secondary|Mullen Scales of Early Learning - Visual Reception Age-equivalent Score|The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor, visual reception, fine motor, receptive language, and expressive language. Shown here are the mean baseline age-equivalent scores from the Visual Reception scale. This scale's age-equivalent scores for each of the five scales are calculated from the raw scores for each scale, using the MSEL Age Equivalents table. Age-equivalent scores for each scale range from 0 to 70 months, with lower scores indicating that a child's visual reception is at a level typical of younger ages, and higher scores indicating that a child's visual reception is at a level typical of older ages.|At baseline visit|||months||Standard Deviation|Mean
687654|NCT01474746|Secondary|Mullen Scales of Early Learning - Visual Reception Raw Score|The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor, visual reception, fine motor, receptive language, and expressive language. Shown here are the mean raw scores from the Visual Reception scale at the 6-month follow-up visit. This scale's raw scores range from 0 to 50. The lower the score on this scale, the weaker the child's ability for visual reception; the higher the score, the greater the ability for visual reception.|At six-month visit|Two subjects from the sertraline arm discontinued - 1 lost to follow up, 1 withdrew consent Three subjects from the placebo arm discontinued - 1 lost to follow up, 2 withdrew consent||units on a scale||Standard Deviation|Mean
687655|NCT01474746|Secondary|Vineland Adaptive Behavior Scales, Second Edition (Vineland-II) Adaptive Behavior Composite Standard Score|The Vineland-II measures the personal and social skills of individuals from birth through adulthood. It was designed to assess handicapped and non-handicapped persons in their personal and social functioning and is appropriate for individuals of all ages. The Vineland-II is a survey that is administered to a parent or caregiver using a semi-structured interview format and is organized around four Behavior Domains: Communication, Daily Living Skills, Socialization, and Motor Skills. Each subtest is scored with a standard score X=100 ± 15 and summed to calculate the Adaptive Behavior Composite (ABC) using age-adjusted scoring tables. Reported here are the ABC mean standard scores for the placebo and treatment groups at the 6-month visit. The ABC ranges from 20 to 160 and indicates low (20-70), moderately low (70-85), adequate (85-115), moderately high (115-130), or high (130-160) overall adaptive functioning.|At six-month visit|This assessment was only introduced to the protocol partway through the trial. As such, only 20 subjects (10 placebo, 10 active) were administered the Vineland-2 at both baseline and follow-up visits.||units on a scale||Standard Deviation|Mean
687656|NCT01474746|Secondary|Sensory Profile - Sensation Seeking Subscale Raw Score|"The Sensory Profile is designed to measure sensory-related difficulties. This measure will be administered to the primary caregiver of each subject to measure the caregiver’s sensory ability and its impact on the subject. Of the four subscales scored in the Sensory Profile, the Sensation Seeking subscale mean raw scores for the placebo and treatment groups are reported here. This subscale has a raw scores range from 0 to 95, with scores 0-6 indicating that the child is sensation seeking much less than others, 7-19 less than others, 20-47 just like the majority of others, 48-60 more than others, and 61-95 much more than others."|At six-month visit|The Sensory Profile assessment was not administered to any subjects at the follow-up visit due to revisions to the protocol.|||||
687657|NCT01474746|Secondary|Sensory Processing Measure-Preschool (SPM-P) Social Participation: Raw Score|The Sensory Processing Measure - Preschool (SPM-P) is a questionnaire that was used to measure specific problems, including under- and over-responsiveness, sensory-seeking behavior, and perceptual problems in multiple environments (at home, at school, and in the community) for children aged 2 to 5 years old. The SPM-P provides norm-referenced standard scores for two higher level integrative functions (praxis and social participation) and five sensor sensory systems (visual, auditory, tactile, proprioceptive, and vestibular functioning). The SPM-P was administered to the caregiver at baseline and again at the 6-month follow-up visit. Reported here is the Social Participation subscale mean raw score from the 6-month visit, which ranges from 8 to 32. The lower the raw score, the more limited the child's level of social participation. The higher the score, the greater the child's level of social participation.|At six-month visit|2 subjects from the sertraline arm discontinued - 1 lost to follow up, 1 withdrew consent. 3 subjects from the placebo arm discontinued - 1 lost to follow up, 2 withdrew consent. The SPM-P was removed from the protocol after the trial was initiated and was therefore not administered to 4 placebo and 3 treatment recipients at the 6-month visit.||units on a scale||Standard Deviation|Mean
687716|NCT01474434|Primary|Aortic Plaque Inflammation (Part B)|This endpoint was palnned for analysis on Part B patients which was never started becasue study got terminated on Part A interim analysis.|Baseline and on treatment day 85 +/- 3 days|The study was terminated based on the interim analysis after patients completed Part A. Part B of the study was never started.|||||
708603|NCT00138125|Secondary|Overall Objective Response Rate||5 years||||||
687658|NCT01474746|Secondary|Preschool Language Scale-fifth Edition (PLS-5): AC+EC Total Raw Score|The Preschool Language Scale-fifth edition (PLS-5) is designed to measure auditory comprehension (AC) and expressive communication (EC) for children birth to 7 years 11 months. The measure examines the child’s attention, play, gestures, social communication, semantics, language structure, integrative language skills and emergent literacy skills. The PLS-5 has expanded coverage of early play behaviors, concepts, Theory of Mind, as well as emergent literacy skills. The PLS-5 yields norm-referenced scores including standard scores, percentile ranks and age equivalents for the AC and EC scales as well as for Total Language (TL). Raw score ranges are 0 to 65 in AC, 0 to 67 in EC, and therefore 0 to 132 in TL (calculated by summing AC+EC raw scores). The higher the scores, the greater the language ability. Shown here are the mean TL raw scores from the 6-month follow-up visit.|At six-month visit|Two subjects from the sertraline arm discontinued - 1 lost to follow up, 1 withdrew consent Three subjects from the placebo arm discontinued - 1 lost to follow up, 2 withdrew consent||units on a scale||Standard Deviation|Mean
687659|NCT01474746|Secondary|Eye Tracking|There are several eye tracking measures, each intended to measure different outcomes including social gaze, social reciprocity, and attention. All stimuli are presented on a Tobii T120 binocular eye tracker monitor. The system consists of a high-resolution camera embedded in a 17-inch TFT monitor. Stimuli consist of sixty colored photographs of adult human face (equal numbers of males and females, different races and ethnicities) from the NimStim Face Stimulus Set, each showing a calm, happy, or fearful expression, and sixty scrambled versions of the face images. Shown here are the averaged response times (in seconds) to the presented stimuli, at the 6-month follow-up visit.|At six-month visit|Data were collected and analyzed on those participants who were compliant with the eye tracking protocol: 13 in the placebo group, and 9 in the active group.||seconds||Standard Deviation|Mean
687660|NCT01474746|Secondary|The Visual Analog Scale|"The Visual Analog Scale will be used to measure the severity of three specific behavioral symptoms chosen by the caregiver(s). Parents mark on a visual line measuring 10 cm with “worst behavior” at 0 cm and best behavior” at 10 cm. The parents choose two key behaviors that they want to target for this trial (e.g., aggression, hyperarousal, anxiety, hyperactivity) and the third target measurement is language/communication. For each behavior the caregiver is instructed to mark their impression of the behavior at baseline visit and again at the 6-month visit. The calculated distance in cm between the baseline and 6-month visit marks thereby demonstrates whether each behavior improved, worsened, or stayed the same during the study, and by how much. Shown here is the mean distance in cm from the worst behavior side, at the 6-month visit. The smaller the value, the worse the behavior. The range is minimum 0 cm to maximum 10 cm."|At six-month visit|"Two subjects from the sertraline arm discontinued - 1 lost to follow up, 1 withdrew consent. An additional subject from the sertraline arm was not administered this measure at the 6-month visit due to staff oversight.
Three subjects from the placebo arm discontinued - 1 lost to follow up, 2 withdrew consent"||units on a scale||Standard Deviation|Mean
687661|NCT01474746|Secondary|The Autism Diagnostic Observation Schedule (ADOS-2)|The Autism Diagnostic Observation Schedule (ADOS-2) assesses and diagnoses autism spectrum disorder. This test was administered at baseline and at the six-month follow-up visit. The choice to administer Module 1 or Module 2 depends on the verbal ability of each subject: Module 1 is used for children who are 31 months and older and/or who do not consistently use phrase speech, and Module 2 is used for children of any age who use phrase speech but are not verbally fluent. The scoring algorithm gives an overall total, which ranges from 0 to 28. The higher the score, the higher the level of autism-related symptoms. The overall total ranges from 0 to 28. On Module 1, for children with few to no words, scores at 11 and above indicate autism spectrum; for children with some words, the cutoff is scores 8 and above. On Module 2, the cutoff for autism spectrum is 7 or above for kids under 5 years, and 8 or above for those 5 years and older.|At six month visit|The ADOS was not administered to all subjects at the six-month visit due to the PI's decision to remove this assessment from the protocol partway through the study; due to staff oversight, however, the ADOS remained listed in the protocol. Also, 2 sertraline and 3 placebo subjects discontinued and were thus administered no follow-up ADOS.||units on a scale||Standard Deviation|Mean
687662|NCT01474746|Secondary|Mullen Scales of Early Learning - Fine Motor Raw Score|The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor, visual reception, fine motor, receptive language, and expressive language. Shown here are the mean raw scores from the Fine Motor scale at the baseline visit. This scale's raw scores range from 0 to 49. The lower the score on this scale, the weaker the child's fine motor skills; the higher the score, the greater the child's fine motor skills.|At baseline visit|||units on a scale||Standard Deviation|Mean
687663|NCT01474746|Secondary|Mullen Scales of Early Learning - Visual Reception Raw Score|The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor, visual reception, fine motor, receptive language, and expressive language. Shown here are the mean baseline raw scores from the Visual Reception scale. This scale's raw scores range from 0 to 50. The lower the score on this scale, the weaker the child's ability for visual reception; the higher the score, the greater the ability for visual reception.|At baseline visit|||units on a scale||Standard Deviation|Mean
687664|NCT01474746|Secondary|Vineland Adaptive Behavior Scales, Second Edition (Vineland-II) - Adaptive Behavior Composite Standard Score|The Vineland-II measures the personal and social skills of individuals from birth through adulthood. It was designed to assess handicapped and non-handicapped persons in their personal and social functioning and is appropriate for individuals of all ages. The Vineland-II is a survey that is administered to a parent or caregiver using a semi-structured interview format and is organized around four Behavior Domains: Communication, Daily Living Skills, Socialization, and Motor Skills. Each subtest is scored with a standard score X=100 ± 15 and summed to calculate the Adaptive Behavior Composite (ABC) using age-adjusted scoring tables. Reported here are the ABC mean standard scores for the placebo and treatment groups baseline. The ABC ranges from 20 to 160 and indicates low (20-70), moderately low (70-85), adequate (85-115), moderately high (115-130), or high (130-160) overall adaptive functioning.|At baseline visit|This assessment was introduced to the protocol partway through the study, and therefore there were only 20 subjects (10 placebo and 10 active) who were administered the Vineland-II at both their baseline and follow-up visits.||units on a scale||Standard Deviation|Mean
687953|NCT01473160|Secondary|Number of Participants With Adequate Lens Fit|Lens fit was assessed by the investigator with a biomicroscope (slit lamp).|Up to 16 hours after lens insertion|All enrolled participants||Participants|||Number
687665|NCT01474746|Secondary|Sensory Profile - Sensation Seeking Subscale Raw Score|"The Sensory Profile is designed to measure sensory-related difficulties. This measure will be administered to the primary caregiver of each subject to measure the caregiver’s sensory ability and its impact on the subject. Of the four subscales scored in the Sensory Profile, the Sensation Seeking subscale mean raw scores for the placebo and treatment groups are reported here. This subscale has a raw scores range from 0 to 95, with scores 0-6 indicating that the child is sensation seeking much less than others, 7-19 less than others, 20-47 just like the majority of others, 48-60 more than others, and 61-95 much more than others."|At baseline visit|The Sensory Profile was not administered to all subjects at baseline due to the PI's decision to remove this assessment from the protocol partway through the study; due to staff oversight, however, this assessment remained listed among the measures in the protocol.||units on a scale||Standard Deviation|Mean
687666|NCT01474746|Secondary|Sensory Processing Measure - Preschool (SPM-P) Social Participation: Raw Score|The Sensory Processing Measure - Preschool (SPM-P) is a questionnaire that was used to measure specific problems, including under- and over-responsiveness, sensory-seeking behavior, and perceptual problems in multiple environments (at home, at school, and in the community) for children aged 2 to 5 years old. The SPM-P provides norm-referenced standard scores for two higher level integrative functions (praxis and social participation) and five sensor sensory systems (visual, auditory, tactile, proprioceptive, and vestibular functioning). Reported here is the Social Participation subscale mean raw score, which ranges from 8 to 32. The lower the raw score, the more limited the child's level of social participation. The higher the score, the greater the child's level of social participation.|At baseline visit|The SPM-P was removed from the protocol after the trial was initiated and was therefore not administered to 1 subject in the active treatment group at baseline.||units on a scale||Standard Deviation|Mean
687667|NCT01474746|Secondary|Preschool Language Scale-fifth Edition (PLS-5): AC+EC Total Raw Score|The Preschool Language Scale-fifth edition (PLS-5) is designed to measure auditory comprehension (AC) and expressive communication (EC) for children birth to 7 years 11 months. The measure examines the child’s attention, play, gestures, social communication, semantics, language structure, integrative language skills and emergent literacy skills. The PLS-5 has expanded coverage of early play behaviors, concepts, Theory of Mind, as well as emergent literacy skills. The PLS-5 yields norm-referenced scores including standard scores, percentile ranks and age equivalents for the AC and EC scales as well as for Total Language (TL). Raw score ranges are 0 to 65 in AC, 0 to 67 in EC, and therefore 0 to 132 in TL (calculated by summing AC+EC raw scores). The higher the scores, the greater the language ability. Shown here are the mean TL raw scores from the baseline visit.|At baseline visit|||units on a scale||Standard Deviation|Mean
687668|NCT01474746|Secondary|Eye Tracking|There are several eye tracking measures, each intended to measure different outcomes including social gaze, social reciprocity, and attention. All stimuli are presented on a Tobii T120 binocular eye tracker monitor. The system consists of a high-resolution camera embedded in a 17-inch TFT monitor. Stimuli consist of sixty colored photographs of adult human face (equal numbers of males and females, different races and ethnicities) from the NimStim Face Stimulus Set, each showing a calm, happy, or fearful expression, and sixty scrambled versions of the face images. Shown here are the averaged response times (in seconds) to the presented stimuli, at the baseline visit.|At baseline visit|Data were collected and analyzed on those participants who were compliant with the eye tracking protocol: 13 in the placebo group, and 9 in the active group.||seconds||Standard Deviation|Mean
687669|NCT01474746|Secondary|Visual Analog Scale|"The Visual Analog Scale will be used to measure the severity of three specific behavioral symptoms chosen by the caregiver(s). Parents mark on a visual line measuring 10 cm with “worst behavior” at 0 cm and best behavior” at 10 cm. The parents choose two key behaviors that they want to target for this trial (e.g., aggression, hyperarousal, anxiety, hyperactivity) and the third target measurement is language/communication. For each behavior the caregiver is instructed to mark their impression of the behavior at baseline visit and again at the 6-month visit. The calculated distance in cm between the baseline and 6-month visit marks thereby demonstrates whether each behavior improved, worsened, or stayed the same during the study, and by how much. Shown here is the mean distance in cm from the worst behavior side, at baseline. The smaller the value, the worse the behavior. The range is minimum 0 cm to maximum 10 cm."|At baseline visit|||centimeters||Standard Deviation|Mean
687670|NCT01474746|Secondary|Autism Diagnostic Observation Schedule|The Autism Diagnostic Observation Schedule (ADOS-2) assesses and diagnoses autism spectrum disorder. This test was administered at baseline and at the six-month follow-up visit. The choice to administer Module 1 or Module 2 depends on the verbal ability of each subject: Module 1 is used for children who are 31 months and older and/or who do not consistently use phrase speech, and Module 2 is used for children of any age who use phrase speech but are not verbally fluent. The scoring algorithm gives an overall total, which ranges from 0 to 28. The higher the score, the higher the level of autism-related symptoms. The overall total ranges from 0 to 28. On Module 1, for children with few to no words, scores at 11 and above indicate autism spectrum; for children with some words, the cutoff is scores 8 and above. On Module 2, the cutoff for autism spectrum is 7 or above for kids under 5 years, and 8 or above for those 5 years and older.|At baseline visit|The ADOS was not administered to all subjects at baseline due to the PI's decision to remove this assessment from the protocol partway through the study; due to staff oversight, however, this assessment remained listed among the measures in the protocol.||units on a scale||Standard Deviation|Mean
687671|NCT01474746|Primary|Change in Mullen Scales of Early Learning - Expressive Language Standard T Score|The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor, visual reception, fine motor, receptive language and expressive language. Based on the raw score obtained by the participant in each scale the scoring software computes T scores, percentile ranks, and age equivalents for each scale separately. Shown here are the baseline and 6-month follow-up T scores from the expressive language scale. T scores have a range of 20 to 80, a mean of 50, and a standard deviation of 10. Any child scoring at or below 1.5 standard deviations below the average is considered presenting significant delays. The lower the T score, the worse the outcome. The MSEL was administered at the baseline visit and at the 6-month follow-up visit.|From baseline visit to six-month visit|Two subjects from the sertraline arm discontinued - 1 lost to follow up, 1 withdrew consent Three subjects from the placebo arm discontinued - 1 lost to follow up, 2 withdrew consent||T scores||Standard Deviation|Mean
707212|NCT00121225|Secondary|Incidence of p53 Allelic Variations (72R or 72P)|Compared using Fisher’s exact test with response.|Baseline||||||
687672|NCT01474746|Primary|Clinical Global Impression - Improvement|The Clinical Global Impression - Improvement (CGI-I) is used to measure the overall behavioral change of an individual and their therapeutic response. The CGI-I is a 3-item observer-rated scale administered by the physician to the caregiver, who assesses improvement using a 7-point scale: 1 = Very much improved; 2 = Much improved; 3 = Minimally improved; 4 = No change; 5 = Minimally worse; 6 = Much worse; and 7 = Very much worse. Therefore, the lower the score, the greater the behavioral improvement as rated by the caregiver. Shown here are the CGI-I mean scores from the 6-month follow-up visit.|6-month follow-up visit score|Two subjects from the sertraline arm discontinued - 1 lost to follow up, 1 withdrew consent Three subjects from the placebo arm discontinued - 1 lost to follow up, 2 withdrew consent||units on a scale||Standard Deviation|Mean
687673|NCT01474746|Primary|Change in Mullen Scales of Early Learning - Expressive Language Raw Score|The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor, visual reception, fine motor, receptive language, and expressive language. Shown here are the baseline and 6-month follow-up raw scores from the expressive language scale. This scale's raw scores range from 0 to 50. The lower the score on this scale, the weaker the ability; the higher the score, the greater the ability. The MSEL was administered at the baseline visit and at the 6-month follow-up visit.|From baseline visit to six-month visit.|Two subjects from the sertraline arm discontinued - 1 lost to follow up, 1 withdrew consent Three subjects from the placebo arm discontinued - 1 lost to follow up, 2 withdrew consent||units on a scale||Standard Deviation|Mean
687674|NCT01474681|Secondary|Disease Free Survival (DFS) Within One Year|Number of participants with Disease Free Survival (DFS) within one year. Patients are considered to have achieved DFS or relapse-free survival if they had not experienced either relapse or death (of any cause)|Month 12|Safety Analysis Set (SAS) comprising all patients who were transplanted is used for analysis of all demographic, safety and engraftment outputs.||participants|||Number
687675|NCT01474681|Secondary|Overall Survival (OS) Within One Year|Number of participants with Overall survival (OS) within one year|Month 12|Safety Analysis Set (SAS) comprising all patients who were transplanted is used for analysis of all demographic, safety and engraftment outputs.||participants|||Number
687676|NCT01474681|Secondary|Incidence of Relapse Within One Year|Number of participants with Incidence of relapse within one year|Month 12|Safety Analysis Set (SAS) comprising all patients who were transplanted is used for analysis of all demographic, safety and engraftment outputs.||participants|||Number
687677|NCT01474681|Secondary|Incidence of Acute Graft Versus Host Disease (aGVHD) Within 100 Days and Chronic Graft Versus Host Disease (cGVHD) Within 1 Year|Number of participants with incidence of Acute Graft Versus Host Disease (aGVHD) within 100 days and Chronic Graft Versus Host Disease (cGVHD) within 1 year|Day 100 and Monnth 12|Safety Analysis Set (SAS) comprising all patients who were transplanted is used for analysis of all demographic, safety and engraftment outputs.||participants|||Number
687678|NCT01474681|Secondary|Incidence of Transplant Related Mortality (TRM) Within 100 Days and One Year|Number of participants with incidence of transplant related mortality (TRM) within 100 days and one year|Day 100 and Month 12|Safety Analysis Set (SAS) comprising all patients who were transplanted is used for analysis of all demographic, safety and engraftment outputs.||participants|||Number
687679|NCT01474681|Secondary|Frequency of Expanded Unit Predominance at Day 100 (DUCBT Recipients Only)|Frequency of expanded unit predominance at day 100 (DUCBT recipients only) unit predominance was assessed by differences in microsatellite patterns between the recipient, HSC835 and the unmanipulated cord blood unit. Evaluation of sorted CD15-positive/CD33-positive myeloid and CD3-positive T cells in the peripheral blood, revealed three patterns: predominance of HSC835, Mixed dominance an unique chimerism pattern was observed with the CD15/CD33 population predominantly derived from HSC835 and the CD3 population almost exclusively derived from the unmanipulated unit, and predominance of the unmanipulated unit|Day 100|Safety Analysis Set (SAS) comprising all patients who were transplanted is used for analysis of all demographic, safety and engraftment outputs.||participants|||Number
687680|NCT01474681|Secondary|Incidence of Platelet Recovery Within Six Months|Incidence of platelet recovery within six months. Number of participants recovering platelet to ≥50,000 × 109/L for at least one week without transfusion in the prior 7 days to the first measurement.|6 months|Safety Analysis Set (SAS) comprising all patients who were transplanted is used for analysis of all demographic, safety and engraftment outputs.||participants|||Number
687681|NCT01474681|Secondary|Incidence of Neutrophil Recovery Within 42 Days|Neutrophil recovery (engraftment) is defined as the first of three consecutive days with ANC > 0.5 x 109/L which occurred for all patients before 42 days post transplant.|42 days|Safety Analysis Set (SAS) comprising all patients who were transplanted is used for analysis of all demographic, safety and engraftment outputs.||participants|||Number
687682|NCT01474681|Primary|Safety and Tolerability of HSC835 for Clinical Use Were Measured by Infusional Toxicity (Within First 48 Hours After Transplant) and Absence of Graft Failure After 32 Days in Excess of That Currently Observed With UCBT.|The safety and tolerability of HSC835 for clinical use were measured by infusional toxicity and absence of graft failure in excess of that currently observed with UCBT. Infusional toxicity – AE from transplant until first 48 hours. Administration of the HSC835 expanded CD34-positive cell product, infused over a period of approximately 15 minutes may theoretically cause adverse reactions based on hemodynamic effects, the release of factors like cytokines through administration into the systemic circulation, or acute hypersensitivity, among others.|32 days|Safety Analysis Set (SAS) comprising all patients who were transplanted is used for analysis of all demographic, safety and engraftment outputs.||participants|||Number
687683|NCT01474590|Primary|The Primary Outcome is Overall Success, a Composite Endpoint Including Efficacy and Safety Measurements|"Overall success is reached when the 2 following criteria are fulfilled :
Overall efficacy: reduction of at least 75% of number of nodules at the end of treatment
Safe treatment: Absence of any listed safety issues"|20 weeks|||count of participants|||Number
687684|NCT01474551|Primary|Overall Objective Response|The Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 will be used to determine treatment response. In order to be considered evaluable for response, a patient must have completed at least 1 cycle of therapy. Patients who do not complete a cycle of therapy can be replaced.|2 years|||participants|||Number
687792|NCT01474200|Secondary|EFFICACY: Net Fluid Removed During the Index Hospitalization|AQ-Fluid removed by AQ plus urine voided minus fluid intake versus urine voided minus fluid intake with the IV diuretics.|Index Hospitalization, an average of 8 days|||mL||Standard Deviation|Mean
687687|NCT01474538|Secondary|Rate of Hypoglycemic Events Per 30 Days|A hypoglycemic episode is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia, or has blood glucose concentration of ≤70 milligrams/deciliter [mg/dL (3.9 millimoles/liter (mmol/L)]. Least Squares (LS) means were adjusted for treatment, period, sequence, baseline hypoglycemic event rate, thiazolidinedione use (Yes/No) and baseline Hemoglobin A1c (HbA1c) (>8% or ≤8%).|Baseline through 16 weeks of each treatment (Periods 1 and 2)|All randomized participants who received at least 1 dose of study drug. Participants were analyzed based on the treatment they received.||hypoglycemic events per 30 days||Standard Error|Least Squares Mean
687688|NCT01474538|Secondary|Total Daily Insulin Dose|Total daily insulin dose was the average of the last 3 days total insulin dose immediately prior to the Week 16 (endpoint) visit of each treatment period. Least Squares (LS) means were adjusted for treatment, period, sequence, thiazolidinedione use (Yes/No), baseline Hemoglobin A1c (HbA1c) (>8% or ≤8%) and participants.|Week 16 of each treatment (Periods 1 and 2)|All randomized participants who received at least 1 dose of study drug and had total daily insulin dose recorded during Treatment Period (TP) 1 or 2. If endpoint data was missing for a specific TP, last observation carried forward (LOCF) method was implemented for that respective TP. Participants were analyzed based on the treatment they received.||units of insulin||Standard Error|Least Squares Mean
687689|NCT01474538|Primary|Glycosylated Hemoglobin A1C (HbA1c) at Endpoint|Hemoglobin A1c (HbA1c) is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over the last 8-12 weeks. Least Squares (LS) means were adjusted for treatment, period, sequence, thiazolidinedione use (Yes/No), baseline HbA1c (>8% or ≤8%) and participants.|After 16 weeks of each treatment (Periods1 and 2)|All randomized participants who received at least 1 dose of study drug and had HbA1c measured at Week 16 of treatment Period 1 or 2. Participants were analyzed based on the treatment they received.||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
687690|NCT01474512|Secondary|Percentage of Participants With Anti-ixekizumab Antibodies|Percentage of participants with treatment-emergent positive anti-ixekizumab antibodies was summarized by treatment group. Percentage was calculated based on the number of evaluable participants and was calculated by number of participants with treatment-emergent positive anti-ixekizumab antibodies / number of evaluable participants * 100%.|Baseline through Week 12|All randomized participants who received at least 1 dose of study drug and had evaluable data.||percentage of participants|||Number
687691|NCT01474512|Secondary|Pharmacokinetics (PK): Trough Concentration at Steady State (Ctrough ss)||Weeks 12 and 24|ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and who had Ctrough ss results at specified time points where the concentration met the definition of being a trough concentration.||micrograms/milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
687692|NCT01474512|Secondary|Percentage of Participants Achieving Palmoplantar PASI (PPASI) of ≥50% (PPASI50), ≥75% (PPASI75), or 100% (PPASI100) Improvement|The Palmoplantar PASI is a composite score derived from the sum of scores for erythema, induration, and desquamation [scores range from 0 (none) to 4 (very severe) for each] multiplied by the score for the extent of palm and sole area involvement [scores range from 0 (0%) to 6 (90 to100%)], with a total scores range from 0 to 72. Participants achieving PPASI50, PPASI75 or PASI100 were defined as having an improvement of at least 50%, 90%, or of 100%, respectively, in the PPASI scores compared to baseline.|Week 12|ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and who had palmoplantar Ps at baseline.||percentage of participants|||Number
687693|NCT01474512|Secondary|Change From Baseline in Patient's Global Assessment of Disease Severity (PatGA)|"The PatGA is a single-item self-reported instrument asking the participant to rate the severity of their psoriasis today by circling a number on the numeric rating scale from 0 (Clear = no psoriasis) to 5 (Severe = the worst their psoriasis has ever been). LS mean change from baseline calculated using MMRM."|Baseline, Week 12|ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and with at least 1 post-baseline PatGA measurement.||units on a scale||Standard Error|Least Squares Mean
687694|NCT01474512|Secondary|Change From Baseline in Medical Outcomes Study 36-item Short Form Health Survey (SF-36) and Physical Component Summary (PCS) and Mental Component Summary (MCS)|The SF-36 is a self-reported instrument that measures the participant's health status during the previous 7 days. It comprises 36-items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped in the PCS and MCS scores. Scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. LS mean change from baseline was calculated using ANCOVA.|Baseline, Week 12|ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and with results at the specified time points, LOCF.||units on a scale||Standard Error|Least Squares Mean
687695|NCT01474512|Secondary|Change From Baseline in Quick Inventory of Depressive Symptomatology-Self Reported 16 Items (QIDS-SR16)|QIDS-SR16 is a participant-administered, 16-item instrument intended to assess the existence and severity of symptoms of depression. A participant is asked to consider each statement as it relates to the way they have felt for the past 7 days and rate each on a 4-point scale: 0 (best) to 3 (worst). The sum of the 16 items corresponding to 9 depression domains [sad mood, concentration, self-criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance (initial, middle and late insomnia or hypersomnia), decrease/increase in appetite/weight, and psychomotor agitation/retardation] to give a single total scores range from 0 to 27, with higher scores indicating greater symptom severity. LS mean change from baseline was calculated using ANCOVA.|Baseline, Week 12|ITT Population: all randomized participants analyzed according to the treatment to which they are assigned, and had results at the specified time points, LOCF.||units on a scale||Standard Error|Least Squares Mean
687717|NCT01474434|Primary|Time to Onset of Exercise-induced Ischemia(Part A, Cohort 1)|Exercise-induced ischemia was defined as the new development of horizontal or down-sloping ST-segment depression (≥ 1mm at 60 milliseconds after the J point) versus baseline tracings.|Baseline and on day 5 of each of the two treatment periods|The study was terminated based on the interim analysis after patients completed Part A. This outcome measure was not part of interim analysis; hence it is not done. .|||||
687793|NCT01474200|Secondary|EFFICACY: Total Fluid Removed During the Index Hospitalization|AQ-Fluid removed by AQ plus urine voided versus urine voided when treated with IV diuretics|Index Hospitalization, an average of 8 days|||mL||Standard Deviation|Mean
687696|NCT01474512|Secondary|Change From Baseline in All Scores of the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) (Quality of Life and Outcome Assessments. Measures: Participant Reported Outcomes [PRO])|WPAI-PSO is a participant administered, 6-item instrument used to assess the impact of Ps on the productivity impairment within the past 7 days. WPAI-PSO has 4 domains: absenteeism, presenteeism (reduced productivity while at work), an overall work impairment score, and impairment in daily activities performed outside of work. Four scores are derived as percentages: absenteeism, presenteeism (reduced productivity while at work), overall work impairment (absenteeism and presenteeism), and impairment in activities performed outside of work. Percentage is calculated as: each score * 100 with greater scores indicating greater impairment. LS mean change from baseline was calculated using analysis of covariance (ANCOVA).|Baseline, Week 12|ITT Population: all randomized participants analyzed according to the treatment to which they are assigned, and had results at specified time points, last observation carried forward (LOCF).||units on a scale||Standard Error|Least Squares Mean
687697|NCT01474512|Secondary|Change From Baseline in Psoriasis Scalp Severity Index (PSSI)|The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (<10%) to 6 (90%-100%) with a total scores range from 0 to 72, with lower scores indicating less severity. LS mean change from baseline was calculated using MMRM.|Baseline, Week 12|ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and had scalp Ps at baseline.||units on a scale||Standard Error|Least Squares Mean
687698|NCT01474512|Secondary|Percent of Body Surface Area (BSA) Involvement of Ps|BSA is a physician rating of the percentage of involvement of Ps for each participant. BSA is assessed on a continuous scale from 0% (no involvement) to 100% (full involvement), where 1% corresponds to the size of the participants hand (includes the palm, fingers and thumb). Total BSA is the sum of handprints from the affected areas. LS mean change from baseline was calculated using MMRM.|Week 12|ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and had at least 1 post-baseline BSA measurement.||percentage of body surface||Standard Error|Least Squares Mean
687699|NCT01474512|Secondary|Change From Baseline in Nail Psoriasis Severity Index (NAPSI)|The NAPSI is a numeric, reproducible, objective tool for evaluation of fingernail Ps. This scale is used to evaluate the severity of fingernail bed Ps and fingernail matrix Ps by area of involvement in the fingernail unit. The fingernail is divided with imaginary horizontal and longitudinal lines into quadrants. Each fingernail is given a score for fingernail bed Ps 0 (none) to 4 (Ps in 4 quadrants of the fingernail) and fingernail matrix Ps 0 (none) to 4 (Ps in 4 quadrants of the matrix), depending on the presence (score of 1) or absence (score of 0) of any of the features of fingernail bed or matrix Ps in each quadrant. The NAPSI score of a fingernail is the sum of scores in fingernail bed and fingernail matrix from each quadrant (maximum of 8). Each fingernail is evaluated, then the sum of all fingernails equals the total NAPSI score with a range from 0 to 80 with higher scores indicating more severe psoriasis. LS mean change from baseline was calculated using MMRM.|Baseline, Week 12|ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and had fingernail Ps at baseline.||units on a scale||Standard Error|Least Squares Mean
687700|NCT01474512|Secondary|Change From Baseline in Dermatology-Specific Quality of Life Index (DLQI) Score|"DLQI is a participant-administered, 10-question, validated, quality-of-life questionnaire that covers 6 domains, including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include 0 (not at all), 1 (a little), 2 (a lot), and 3 (very much) and unanswered (not relevant) responses were scored as 0. Total scores range from 0 to 30, with higher score indicating greater quality of life is impairment. A 5-point change from baseline is considered clinically relevant. Least squares (LS) mean change from baseline was calculated using mixed model repeated measures (MMRM)."|Baseline, Week 12|ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and who had at least 1 post-baseline DLQI measurement.||units on a scale||Standard Error|Least Squares Mean
687701|NCT01474512|Secondary|Percentage of Participants With Itch Numeric Rating Scale (Itch NRS) Score ≥4 Point Reduction From Baseline|The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 (no itch) and 10 (worst itch imaginable). Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours.|Baseline, Week 12|ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and had an Itch NRS score ≥4 at baseline. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for NRI analysis.||percentage of participants|||Number
687702|NCT01474512|Secondary|Percentage of Participants Maintaining sPGA 0 or 1 After Re-Randomization at Start of Maintenance Dosing Period|The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe).|Week 60|Maintenance Period Primary Population (MPPP): all randomized participants from Period 2 who achieved sPGA (0, 1), were re-randomized at Week 12 and who received at least 1 dose of study treatment Period 3 period. Participants did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for NRI analysis.||percentage of participants|||Number
687718|NCT01474434|Primary|Time to Onset of Angina (Part A, Cohort 1)|Time to onset of angina was defined as the elapsed time between the start of exercise and the onset of anginal chest pain as reported by the patient and recorded by the performing investigator.|Baseline and on day 5 of each of the two treatment periods|The study was terminated based on the interim analysis after patients completed Part A. This outcome measure was not part of interim analysis; hence it is not done. .|||||
687794|NCT01474200|Primary|Time to First Heart Failure (HF) Event|"Time to first HF event within 90 days after discharge from index HF hospitalization. HF events are defined as
HF rehospitalization or
unscheduled outpatient or emergency room treatment with IV loop diuretics or
unscheduled outpatient Aquapheresis treatment"|90 days after discharge from index HF hospitalization.|Results reported are for the 25th percentile.||Days||95% Confidence Interval|Median
688216|NCT01468337|Secondary|Changes in the Maximum Subretinal Fluid Volume as Measured on Optical Coherence Tomography (OCT) at Week 48 Compared to Baseline||Baseline and Week 48||||||
687703|NCT01474512|Secondary|Percentage of Participants Achieving PASI 90% (PASI90) or 100% (PASI100) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Ps Measure: PASI)|The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease). Participants achieving PASI90 or PASI100 were defined as having an improvement of ≥90% or of 100% respectively in PASI scores compared to baseline.|Week 12|ITT Population: all randomized participants analyzed according to the treatment to which they are assigned. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for NRI analysis.||percentage of participants|||Number
687704|NCT01474512|Secondary|Percentage of Participants Achieving an sPGA of 0 (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Ps Measure: sPGA)|The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe).|Week 12|ITT Population: all randomized participants analyzed according to the treatment to which they are assigned. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for NRI analysis.||percentage of participants|||Number
687705|NCT01474512|Primary|Percentage of Participants Achieving ≥75% Improvement in Ps Area and Severity Index (PASI75) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis Measure: PASI)|The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease). Participants achieving PASI75 were defined as having an improvement of ≥75% in the PASI score compared to baseline.|Week 12|ITT Population: all randomized participants analyzed according to the treatment to which they were assigned. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for NRI analysis.||percentage of participants|||Number
687706|NCT01474512|Primary|Percentage of Participants With Static Physician Global Assessment (sPGA) of 0 or 1 (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Ps Measure: sPGA)|"The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of 0 or 1 with at least a 2-point improvement from baseline."|Week 12|Intent to Treat (ITT) Population: all randomized participants analyzed according to the treatment to which they were assigned. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for Non-Responder Imputation (NRI) analysis.||percentage of participants|||Number
687707|NCT01474434|Secondary|Adiponectin Level ( Part B)||Part B; Baseline, day 15, day 43 and day 85|The study was terminated based on the interim analysis on Part A, cohort 1 after patients completed Part A. Part B of the study was not commenced.|||||
687708|NCT01474434|Secondary|C-reactive Protein (CRP) Level (Part A)||Baseline, day 4 and day 5, of each treatment period|The study was terminated based on the interim analysis on Part A, Cohort 1 after patients completed Part A. The analysis of this assessment was not part of interim analysis; hence it is not done.|||||
687709|NCT01474434|Secondary|Interleukin-6 (IL-6) Level (Part A)||Baseline, day 4 and day 5, of each treatment period|The study was terminated based on the interim analysis on Part A, Cohort 1 after patients completed Part A. The analysis of this assessment was not part of interim analysis; hence it is not done.|||||
687710|NCT01474434|Secondary|Other Related Lipid Parameters (Part A)||Baseline, day 4 and day 5 of each treatment period|The study was terminated based on the interim analysis on Part A, Cohort 1 after patients completed Part A. The analysis of this assessment was not part of interim analysis; hence it is not done.|||||
687711|NCT01474434|Secondary|Pharmacokinetics of Pradigastat (LCQ908): Plasma Concentration (Part A)||Part A: Day 4 and day 5 of each treatment period|The study was terminated based on the interim analysis on Part A, Cohort 1 after patients completed Part A. The analysis of this assessment was not part of interim analysis; hence it is not done.|||||
687712|NCT01474434|Secondary|Postprandial Triglycerides (Part A, Cohort 2)|For both each treatment period, postprandial triglycerides were measured on Day 5 i.e. on 0 hour (before breakfast), two hours and four hours post high-fat breakfast. Results are from an ANCOVA model on change from baseline in the log domain with log(baseline), treatment, sequence and period as fixed effects. Baseline is the Day -1 value within period. The data reported is ratio of geometric mean between post-treatment and baseline data.|0 hour (before breakfast), 2 and 4 hours post high-fat breakfast on day 5|The efficacy analysis set included all patients who took more than 80% of study medication as assessed by drug accountability, had no major protocol deviations, and had a valid assessment of the primary efficacy variables at both baseline and post treatment visits.||ratio||Standard Error|Geometric Mean
687713|NCT01474434|Secondary|Postprandial Triglycerides (Part A, Cohort 1)|For both each treatment period, postprandial triglycerides were measured on Day 5 i.e. on 0 hour(before breakfast), two hours and four hours post high-fat breakfast. Results are from an ANCOVA model on change from baseline in the log domain with log(baseline), treatment, sequence and period as fixed effects. Baseline is the Day -1 value within period. The data reported is ratio of geometric mean between post-treatment and baseline data.|0 hour (before breakfast), 2 and 4 hours post high-fat breakfast on day 5|The efficacy analysis set included all patients who took more than 80% of study medication as assessed by drug accountability, had no major protocol deviations, and had a valid assessment of the primary efficacy variables at both baseline and post treatment visits.||ratio||Standard Error|Geometric Mean
687719|NCT01474434|Primary|Change From Baseline in Total Exercise Duration (Part A, Cohort 1)|Total exercise duration was the elapsed time between the start of exercise and termination of exercise for severe angina, dyspnea or extreme fatigue. This primary endpoint was only for Part A, Cohort 1 patients.|Baseline and on day 5 of each of the two treatment periods|Efficacy analysis set- Patients who took > 80% of study drug as assessed by drug accountability, had no major protocol deviations, and had a valid assessment of total exercise duration at both baseline and post-treatment visits. Patients who had no baseline or post-treatment exercise duration data in 1 of 2 periods were excluded from the analysis.||minute||Standard Error|Least Squares Mean
687720|NCT01474434|Primary|Change From Baseline in Myocardial Perfusion Reserve Index (MPRi) Overall Mean (Part A, Cohort 1)|MPRi (myocardial perfusion reserve index) is a measure of coronary microvascular function. Myocardial perfusion scans using 0.05 mmol/kg of gadolinium contrast were acquired at rest and under stress (pharmacological stress induced with adenosine 140 μg/kg/min for three minutes). An independent central reader performed the cardiac image analysis of all time points including the calculation of the myocardial perfusion reserve index from the ratio of the global stress myocardial blood flow divided by the resting blood flow values. Higher/increased index indicates improved flow/better outcome. This primary endpoint was only for Part A, Cohort 1 patients.|Baseline, and on day 5 of each of the two treatment periods|Efficacy analysis set - Patients who took > 80% of study drug as assessed by drug accountability, had no major protocol deviations, and had a valid assessment of MPRi at both baseline and post-treatment visits. Patients who had no baseline or post-treatment MPRi data in 1 of 2 periods were excluded from the analysis.||myocardial perfusion reserve index||Standard Error|Least Squares Mean
687721|NCT01474317|Secondary|Number of Subjects Able to Perform Given Tasks Using Product Labeling for Instruction|After reading the instructions for use, and without assistance from the study staff, subjects use the BGMS to utilize some of the additional features of the system. Study staff documents Yes or No 'Did the subject complete the task successfully?'|1 hour|||participants|||Number
687722|NCT01474317|Secondary|Percent of Venous Blood Glucose Results Within +/- 5to15mg/dL (<75mg/dL) or Within +/- 5to20% (>=75mg/dL) of Laboratory Glucose Method|Study staff tested subject venous blood using an investigational Blood Glucose Monitoring System (BGMS). Venous BGMS results are compared with venous plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI venous plasma results are used to calculate the number of BGMS results within +/- 5to15mg/dL (<75mg/dL YSI venous plasma) or +/- 5to20% (>=75mg/dL YSI venous plasma).|1 hour|Venipuncture was unsuccessful for one subject. 223 (224-1) venous blood test results were analyzed.||percentage of meter test results|||Number
687723|NCT01474317|Secondary|Percent of Glucose Results From Alternative Site Testing (AST) of the Palm Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method|Untrained subjects with diabetes self-test Alternative Site (AST) Palm blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS AST results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma BG results are used to calculate the number of AST BGMS results within +/- 15mg/dL (<75mg/dL YSI capillary plasma) or +/- 20% (>=75mg/dL YSI capillary plasma).|1 hour|Blood data for 3 subjects were not evaluable because time defined in protocol was exceeded between meter test and blood sample preparation for reference method. 221 (224-3) blood test results were analyzed.||percentage of meter test results|||Number
687724|NCT01474317|Primary|Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 5to15mg/dL (<100mg/dL) or Within +/- 5to15% (>=100mg/dL) of Laboratory Glucose Method|Untrained subjects with diabetes self-test fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results are used to calculate the number of BGMS results within +/- 5to15mg/dL (<100mg/dL YSI capillary plasma) or +/- 5to15% (>=100mg/dL YSI capillary plasma). Site staff tested in parallel after subjects.|1 hour|Blood data for three subjects were not evaluable because time defined in protocol was exceeded between meter test and blood sample preparation for reference method. 221 (224-3) blood test results were analyzed.||percentage of meter test results|||Number
687725|NCT01474291|Secondary|Percentage of Participants With Adverse Events|An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory finding if accompanied by clinical symptoms, results in a change in study treatment, results in a medical intervention or a change in concomitant therapy or clinically significant in the investigator’s judgment), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Up to 30 months|Safety population, defined as participants who received at least one infusion of tocilizumab.||percentage of participants|||Number
687726|NCT01474291|Secondary|Percentage of Participants With Acceptable Health State Assessed by the Patient Acceptable Symptom State (PASS) Questionnaire.|"Participants were asked: If you were to remain in the same condition for the next few months as you have been over the last 8 days, would this be 1) acceptable, 2) unacceptable? The percentage of participants who responded acceptable at each time point is presented."|Baseline; Month 6; Month 12|Participants in the Efficacy population who received at least one infusion of tocilizumab, who met all inclusion and exclusion criteria, and with available data at the respective time point.||percentage of participants|||Number
687727|NCT01474291|Secondary|Mean Change From Baseline in Rheumatoid Arthritis Impact of Disease (RAID) Score|The RAID questionnaire is a participant-reported outcome measure evaluating the impact of rheumatoid arthritis on participant quality of life. This composite index score ranges from 0 (best) to 10 (worst) and includes questions regarding 7 domains (pain, functional disability assessment, fatigue, sleep, physical well-being, emotional well-being, coping). A decrease in score corresponds to improvement in participant-assessed health state.|Baseline; Month 6, Month 12|Participants in the Efficacy population who received at least one infusion of tocilizumab, who met all inclusion and exclusion criteria, and with available data at the respective time point.||units on a scale||Standard Deviation|Mean
687750|NCT01474239|Secondary|Percentage of Participants With Karnofsky Performance Status (KPS) Deterioration|Deterioration of KPS was defined as a decrease of at least 20 percentage points with respect to the screening. KPS is an 11-level score which ranges between 0 (death) to 100 (complete healthy status); a higher score represents a higher ability to perform daily tasks.|Baseline until KPS deterioration (up to 691 days)|ITT population. Here, number of participants analyzed signified participants with evaluable data for this outcome.||percentage of participants|||Number
687728|NCT01474291|Secondary|Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score|The HAQ-DI is a participant-reported assessment of ability to perform daily living activities. This composite index score ranges from 0 (normal) to 3 (total functional disability) and includes questions regarding 8 domains (dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week). A decrease in score corresponds to improvement in participant-assessed health state.|Baseline; Month 6; Month 12|Participants in the Efficacy population who received at least one infusion of tocilizumab, who met all inclusion and exclusion criteria, and with available data at the respective time point.||units on a scale||Standard Deviation|Mean
687729|NCT01474291|Secondary|Percentage of Participants With Good or Moderate European League Against Rheumatism (EULAR) Response at Month 12|"EULAR response was categorized as good or moderate response and was calculated as the difference between DAS28-ESR scores at baseline and Month 12. DAS28-ESR was calculated from the number of swollen joints and tender joints using the 28-joint count, ESR (mm/hour) and patient's global assessment of disease activity; scores range from 0 to 10, where lower scores indicate less disease activity.
If diminution from baseline >1.2 and score ≤3.2 at Month 12 = good response
If diminution from baseline >1.2 and score >3.2 at Month 12 = moderate response
If diminution from baseline >0.6 and ≤1.2, and score ≤5.1 at Month 12 = moderate response
If diminution from baseline >0.6 and ≤1.2, and score >5.1 at Month 12 = non-response
If diminution from baseline ≤1.2 at Month 12 = non-response
Participants with missing data were considered as non-response"|Month 12|Efficacy population, defined as all participants who received at least one infusion of tocilizumab and who met all inclusion and exclusion criteria.||percentage of participants|||Number
687730|NCT01474291|Secondary|Percentage of Participants With American College or Rheumatology (ACR)20, ACR50, and ACR70 at Month 12|ACR20/50/70 response was calculated as improvement (from baseline) of at least 20/50/70% (respectively) of tender and of swollen joints, and improvement from baseline of least 20/50/70% (respectively) in at least 3 of the 5 following parameters: participant's pain assessment, patient's global assessment of disease activity, physician’s global assessment of disease activity, health assessment questionnaire disability index (HAQ-DI) score, and ESR (mm/hour) or CRP (mg/L). Participants with missing data were considered to have failed to achieve the outcome.|Month 12|Efficacy population, defined as all participants who received at least one infusion of tocilizumab and who met all inclusion and exclusion criteria.||percentage of participants|||Number
687731|NCT01474291|Secondary|Percentage of Participants With SDAI Remission at Month 12|SDAI was calculated from the number of swollen joints and tender joints using the 28-joint count, CRP (mg/L), and the patient’s global assessment of disease activity and physician's global assessment of disease activity; SDAI scores range from 0 to 86, where lower scores indicate less disease activity. A score of ≤3.3 was considered to be SDAI remission. Participants with missing data were considered to have failed to achieve the outcome.|Month 12|Efficacy population, defined as all participants who received at least one infusion of tocilizumab and who met all inclusion and exclusion criteria.||percentage of participants|||Number
687732|NCT01474291|Secondary|Percentage of Participants With Simplified Disease Activity Index (SDAI) LDA at Month 12|SDAI was calculated from the number of swollen joints and tender joints using the 28-joint count, C-reactive protein (CRP) (milligrams per liter (mg/L)) per , and the patient’s global assessment of disease activity and physician's global assessment of disease activity; SDAI scores range from 0 to 86, where lower scores indicate less disease activity. A score of ≤11 was considered to be SDAI LDA. Participants with missing data were considered to have failed to achieve the outcome.|Month 12|Efficacy population, defined as all participants who received at least one infusion of tocilizumab and who met all inclusion and exclusion criteria.||percentage of participants|||Number
687733|NCT01474291|Secondary|Percentage of Participants With CDAI Remission at Month 12|CDAI was calculated from the number of swollen joints and tender joints using the 28-joint count and the patient’s global assessment of disease activity and physician's global assessment of disease activity; CDAI scores range from 0 to 76, where lower scores indicate less disease activity. A score of ≤2.8 was considered to be CDAI remission. Participants with missing data were considered to have failed to achieve the outcome.|Month 12|Efficacy population, defined as all participants who received at least one infusion of tocilizumab and who met all inclusion and exclusion criteria.||percentage of participants|||Number
687734|NCT01474291|Secondary|Percentage of Participants With Clinical Disease Activity Index (CDAI) LDA at Month 12|CDAI was calculated from the number of swollen joints and tender joints using the 28-joint count and the patient’s global assessment of disease activity and physician's global assessment of disease activity; CDAI scores range from 0 to 76, where lower scores indicate less disease activity. A score of ≤10 was considered to be CDAI LDA. Participants with missing data were considered to have failed to achieve the outcome.|Month 12|Efficacy population, defined as all participants who received at least one infusion of tocilizumab and who met all inclusion and exclusion criteria.||percentage of participants|||Number
687735|NCT01474291|Secondary|Percentage of Participants With DAS28-ESR Remission at Month 12|DAS28-ESR was calculated from the number of swollen joints and tender joints using the 28-joint count, ESR (mm/hour) and patient's global assessment of disease activity; scores range from 0 to 10, where lower scores indicate less disease activity. A score of <2.6 was considered to be DAS28-ESR remission. Participants with missing data were considered to have failed to achieve the outcome.|Month 12|Efficacy population, defined as all participants who received at least one infusion of tocilizumab and who met all inclusion and exclusion criteria.||percentage of participants|||Number
687736|NCT01474291|Secondary|Percentage of Participants in Disease Activity Score Based on 28-joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR) Low Disease Activity (LDA) at Month 12|DAS28-ESR was calculated from the number of swollen joints and tender joints using the 28-joint count, ESR (mm/hour) and patient's global assessment of disease activity; scores range from 0 to 10, where lower scores indicate less disease activity. A score of ≤3.2 was considered to be DAS28-ESR LDA. Participants with missing data were considered to have failed to achieve the outcome.|Month 12|Efficacy population, defined as all participants who received at least one infusion of tocilizumab and who met all inclusion and exclusion criteria.||percentage of participants|||Number
687785|NCT01474200|Secondary|CLINICAL: Total Number of Days Rehospitalized for Heart Failure (HF) at 30 and 90 Days After Discharge|Days rehospitalized for HF symptoms requiring hospital, emergency room or clinic treatment involving the use of IV diuretics and /or positive inotropic or vasodilator drugs.|Within 30 days and 90 days after hospital discharge|||Days|||Number
687737|NCT01474291|Secondary|Percentage of Participants With at Least One csDMARD Intensification During the Study|csDMARD intensification was defined as an addition of a csDMARD without suppression of other csDMARD, dose increase of a csDMARD, switch (addition and suppression) of a csDMARD without intolerance, biological abnormality or symptom improvement to the suppressed csDMARD, or modification of the MTX administration route (from oral route to intramuscular/subcutaneous) with dose increase or maintenance.|Up to 30 months|Participants in Efficacy population who received at least 1 infusion of tocilizumab, who met all inclusion/exclusion criteria, and with no permanent discontinuation of tocilizumab treatment over the study period. For efficacy criteria with response/non response values, participants with non-evaluable response were considered as non-responders.||percentage of participants|||Number
687738|NCT01474291|Secondary|Percentage of Participants With No Modification of Tocilizumab Treatment Over the Study Period|The percentage of participants with no modifications (dose modification or discontinuation) is presented.|Up to 30 months|Efficacy population, defined as all participants who received at least one infusion of tocilizumab and who met all inclusion and exclusion criteria.||percentage of participants|||Number
687739|NCT01474291|Secondary|Percentage of Participants Who Received Tocilizumab Infusions Over the Study Period|The percentage of participants who received infusions is presented by category of total infusions received over the study period.|Up to 13.4 months|Efficacy population, defined as all participants who received at least one infusion of tocilizumab and who met all inclusion and exclusion criteria.||percentage of participants|||Number
687740|NCT01474291|Secondary|Mean Number of Tocilizumab Infusions Over the Study Period||Up to 30 months|Efficacy population, defined as all participants who received at least one infusion of tocilizumab and who met all inclusion and exclusion criteria.||infusions||Standard Deviation|Mean
687741|NCT01474291|Secondary|Percentage of Participants Receiving Tocilizumab Monotherapy Who Discontinued Unspecified Conventional Synthetic Disease-modifying Antirheumatic Drugs (csDMARDs)|The percentage of participants who discontinued treatment with unspecified csDMARDs prior to being assigned to tocilizumab monotherapy is presented by reason for discontinuation.|Day 1 (assessment of discontinuations within prior 2 years)|Participants in the Tocilizumab Monotherapy group (Efficacy population) who discontinued treatment with unspecified csDMARDs and with available data.||percentage of participants|||Number
687742|NCT01474291|Secondary|Percentage of Participants Receiving Tocilizumab Monotherapy Who Discontinued Hydroxychloroquine|The percentage of participants who discontinued hydroxychloroquine treatment prior to being assigned to tocilizumab monotherapy is presented by reason for discontinuation.|Day 1 (assessment of discontinuations within prior 2 years)|Participants in the Tocilizumab Monotherapy group (Efficacy population) who discontinued hydroxychloroquine and with available data.||percentage of participants|||Number
687743|NCT01474291|Secondary|Percentage of Participants Receiving Tocilizumab Monotherapy Who Discontinued Sulfasalazine|The percentage of participants who discontinued sulfasalazine treatment prior to being assigned to tocilizumab monotherapy is presented by reason for discontinuation.|Day 1 (assessment of discontinuations within prior 2 years)|Participants in the Tocilizumab Monotherapy group (Efficacy population) who discontinued sulfasalazine and with available data.||percentage of participants|||Number
687744|NCT01474291|Secondary|Percentage of Participants Receiving Tocilizumab Monotherapy Who Discontinued Leflunomide|The percentage of participants who discontinued leflunomide treatment prior to being assigned to tocilizumab monotherapy is presented by reason for discontinuation.|Day 1 (assessment of discontinuations within prior 2 years)|Participants in the Tocilizumab Monotherapy group (Efficacy population) who discontinued leflunomide and with available data.||percentage of participants|||Number
687745|NCT01474291|Secondary|Percentage of Participants Receiving Tocilizumab Monotherapy Who Discontinued Methotrexate (MTX)|"The percentage of participants who discontinued MTX treatment prior to being assigned to tocilizumab monotherapy is presented by reason for discontinuation.
Reason for discontinuation Other Intolerance = intolerance other than cytopenia or hepatic cytolysis."|Day 1 (assessment of discontinuations within prior 2 years)|Participants in the Tocilizumab Monotherapy group (Efficacy population) who discontinued MTX and with available data.||percentage of participants|||Number
687746|NCT01474291|Primary|Number of Participants Assigned Tocilizumab Monotherapy Versus Tocilizumab as Part of Combination Therapy at Study Inclusion|The number of participants assigned to tocilizumab monotherapy versus tocilizumab combination therapy is reported. A multivariate analysis was performed to search for predictive factors for the initiation of tocilizumab in monotherapy.|Day 1|Efficacy population, defined as all participants who received at least one infusion of tocilizumab and who met all inclusion and exclusion criteria.||participants|||Number
687747|NCT01474239|Secondary|Time to WHO PS Deterioration|Time to WHO PS deterioration was defined as the time from randomization to the first date of deterioration of the WHO performance status score. WHO PS deterioration was defined as a decrease of at least 1 point with respect to the screening value. WHO PS is a 6-level score which ranges between 0 (fully active) to 5 (death); a lower score represents a higher ability to perform daily tasks.|Baseline until WHO PS deterioration (Up to 691 days)|ITT population.||months||95% Confidence Interval|Median
687748|NCT01474239|Secondary|Percentage of Participants With World Health Organization (WHO) Performance Status (PS) Deterioration|WHO PS deterioration was defined as a decrease of at least 1 point with respect to the screening value. WHO PS is a 6-level score which ranges between 0 (fully active) to 5 (death); a lower score represents a higher ability to perform daily tasks.|Baseline until WHO PS deterioration (Up to 691 days)|ITT population.||percentage of participants|||Number
687749|NCT01474239|Secondary|Time to Karnofsky Performance Status (KPS) Deterioration|Time to KPS deterioration was defined as the time from screening to the first date of deterioration of the KPS score. Deterioration of KPS was defined as a decrease of at least 20 percentage points with respect to the screening. KPS is an 11-level score which ranges between 0 (death) to 100 (complete healthy status); a higher score represents a higher ability to perform daily tasks. Time to KPS deterioration was estimated using Kaplan Meier method. If the participant was not known to have the event, time was censored at the last available visit date.|Baseline until KPS deterioration (up to 691 days)|ITT population. Here, number of participants analyzed signified participants with evaluable data for this outcome.||months||95% Confidence Interval|Median
687786|NCT01474200|Secondary|CLINICAL: Length of Stay (LOS) During the Index Hospitalization|Number of days patient is in hospital for HF treatment.|Index hospitalization admission to index hospitalization discharge|||Days||Standard Deviation|Mean
687751|NCT01474239|Secondary|Percentage of Participants in Each Class of Corticosteroid Use|Corticosteroid use was classified as: 1. No Change (if corticosteroid dose at each assessment was equal to baseline); 2. Decreased (if corticosteroid dose at each assessment was lower than baseline); 3. Increased (corticosteroid dose at each assessment was greater than baseline).|Weeks 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, post-treatment follow-up (up to Day 691)|"ITT population. Here, the number of participants analyzed signified participants with evaluable data for this outcome, and n signified participants with evaluable data for specified category for each arm, respectively."||percentage of participants|||Number
687752|NCT01474239|Secondary|Time to Corticosteroid Initiation|Time to corticosteroid initiation was defined as the time from screening to the start date of the first corticosteroid administration in participants not receiving corticosteroids at screening. The participant had the event if he/she started on corticosteroids with a dosage ≥2 mg dexamethasone equivalent. Instead, if the participant was not known to have the event, time was censored at the last available visit date. Time to corticosteroid initiation was estimated using Kaplan Meier method.|Baseline until recurrence (up to 691 days)|ITT population. Number of participants analyzed signified participants who were not receiving corticosteroids at screening.||months||95% Confidence Interval|Median
687753|NCT01474239|Secondary|Percentage of Participants With Corticosteroid Initiation During the Study Period|Corticosteroid initiation was assessed in participants not receiving corticosteroids at screening. The participant had the event if he/she started on corticosteroids with a dosage greater than equal to (>/=) 2 mg dexamethasone equivalent.|Baseline until recurrence (up to 691 days)|ITT population. Number of participants analyzed signified participants who were not receiving corticosteroids at screening.||percentage of participants|||Number
687754|NCT01474239|Secondary|Change From Screening in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores at Weeks 8, 16, 24, 32, 40, 48, 56, 64, and 72|EORTC QLQ-C30: included global health status/quality of life (QOL), functional scales (physical, role, cognitive, emotional, and social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulties). Most questions used a 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used a 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores were averaged and transformed to 0-100 scale; a higher score for Global QOL/functional scales indicates better level of QOL/functioning, or a higher score for symptom scale indicates greater degree of symptoms.|Screening, Weeks 8, 16, 24, 32, 40, 48, 56, 64, and 72|"ITT population. Here, the number of participants analyzed signified participants with evaluable data for this outcome, and n signified participants with evaluable data for specified category for each arm, respectively."||units on a scale||Standard Deviation|Mean
687755|NCT01474239|Secondary|Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR)|Percentage of participants achieving CR or PR as overall response between first drug administration and documented disease progression were calculated. Tumor response was evaluated according to both the RANO and the Macdonald response criteria. As per Macdonald criteria, CR was defined as the disappearance of all enhancing disease, sustained for at least 4 weeks, and no new lesions along with clinical features of clinically stable or improved, with no corticosteroid; PR was defined as a 50% or more decrease of all measurable enhancing lesions, sustained for at least 4 weeks, and no new lesion along with clinical features of clinically stable or improved, with stable or reduced corticosteroids. RANO criteria defined CR and PR the same as Macdonald criteria with the following additions: CR - improved non enhancing T2/FLAIR lesions; PR - no progression of non-measurable disease, stable or improved non enhancing FLAIR/T2 lesions.|Baseline until disease progression or death (baseline, 46 days after first administration of study drug, and thereafter every 56 days up to 691 days)|ITT population.||percentage of participants|||Number
687756|NCT01474239|Secondary|Percentage of Participants Alive 30 Days After Last Dose of Study Drug|OS was defined as the time in months from the start of treatment to death due to any cause. If a participant was not known to have died, time was censored at the last date the participant was known to be alive, which was defined as the latest among date of last visit, date of last sample collected for laboratory exam, date of MRI assessment, date of last treatment, date of discontinuation and date of last available follow-up visit. Participants with no information after baseline were censored at Day 1. OS was estimated by the Kaplan-Meier method.|30 days after last dose of study drug (up to Day 600)|ITT population. Here, the number of participants analyzed signified participants with evaluable data for this outcome.||percentage of participants||95% Confidence Interval|Number
687757|NCT01474239|Secondary|Percentage of Participants Alive 12 Months After Start of Treatment|OS was defined as the time in months from the start of treatment to death due to any cause. If a participant was not known to have died, time was censored at the last date the participant was known to be alive, which was defined as the latest among date of last visit, date of last sample collected for laboratory exam, date of MRI assessment, date of last treatment, date of discontinuation and date of last available follow-up visit. Participants with no information after baseline were censored at Day 1. OS was estimated by the Kaplan-Meier method.|12 months|ITT population. Here, the number of participants analyzed signified participants with evaluable data for this outcome.||percentage of participants||95% Confidence Interval|Number
687758|NCT01474239|Secondary|Percentage of Participants Alive 9 Months After Start of Treatment|OS was defined as the time in months from the start of treatment to death due to any cause. If a participant was not known to have died, time was censored at the last date the participant was known to be alive, which was defined as the latest among date of last visit, date of last sample collected for laboratory exam, date of MRI assessment, date of last treatment, date of discontinuation and date of last available follow-up visit. Participants with no information after baseline were censored at Day 1. OS was estimated by the Kaplan-Meier method.|9 months|ITT population.||percentage of participants||95% Confidence Interval|Number
687787|NCT01474200|Secondary|EFFICACY: Changes in B-type Natriuretic Peptide (BNP) Levels Over Time|Change in BNP levels over time at 72 hours, discharge, and 90 days after discharge.|Baseline and at 72 hours from baseline, hospital discharge and at 90 days after hospital discharge|Number of participants analyzed changes over time. Baseline: n=108 for AQ arm, n=109 for LD arm. 72 hours from baseline: n=81 for AQ arm, n=77 for LD arm. Discharge: n=83 for AQ arm, n=89 for LD arm. 90 days follow up: n=65 for AQ arm, n=76 for LD arm.||pg/mL||Standard Deviation|Mean
687983|NCT01472822|Secondary|Changes in DPD(Deoxypyridinoline)|DPD(Deoxypyridinoline) was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis||nanoMolar DPD per milliMolar creatine||Standard Deviation|Mean
687759|NCT01474239|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time in months from the start of treatment to the date of the first occurrence of disease progression or death from any cause, whichever occurred first. PFS was estimated by the Kaplan-Meier method. Progression was assessed using the RANO or the Macdonald Response Criteria, whichever occurred first. As per RANO criteria, progression was defined as 25% or more increase in enhancing lesions despite stable or increasing steroid dose; increase (significant) in non-enhancing T2/FLAIR lesions, not attributable to other non-tumor causes; any new lesions; and clinical deterioration (not attributable to other non-tumor causes and not due to steroid decrease). As per Macdonald criteria, progression was defined as 25% or more increase in enhancing lesions; any new lesions; and clinical deterioration.|Baseline until disease progression or death (baseline, 46 days after first administration of study drug, and thereafter every 56 days up to 691 days)|ITT population.||months||95% Confidence Interval|Median
687760|NCT01474239|Secondary|Percentage of Participants Who Were Alive and Progression Free 6 Months After Start of Treatment|Progression-free survival (PFS) was defined as the time in months from the start of treatment to the date of the first occurrence of disease progression or death from any cause, whichever occurred first. PFS was estimated by the Kaplan-Meier method. Progression was assessed using Response Assessment in Neuro-Oncology (RANO) or Macdonald Response Criteria, whichever occurred first. As per the RANO criteria, progression was defined as 25% or more increase in enhancing lesions despite stable or increasing steroid dose; increase (significant) in non-enhancing T2/FLAIR lesions, not attributable to other non-tumor causes; any new lesions; and clinical deterioration (not attributable to other non-tumor causes and not due to steroid decrease). As per the Macdonald criteria, progression was defined as 25% or more increase in enhancing lesions; any new lesions; and clinical deterioration.|6 months|ITT population.||percentage of participants||95% Confidence Interval|Number
687761|NCT01474239|Primary|Overall Survival (OS)|OS was defined as the time in months from the start of treatment to death due to any cause. If a participant was not known to have died, time was censored at the last date the participant was known to be alive, which was defined as the latest among date of last visit, date of last sample collected for laboratory exam, date of MRI assessment, date of last treatment, date of discontinuation and date of last available follow-up visit. Participants with no information after baseline were censored at Day 1. OS was estimated by the Kaplan-Meier method.|Baseline until death (up to 691 days)|ITT population.||months||95% Confidence Interval|Median
687762|NCT01474239|Primary|Percentage of Participants Alive 6 Months After Start of Treatment|Overall survival (OS) was defined as the time in months from the start of treatment to death due to any cause. If a participant was not known to have died, time was censored at the last date the participant was known to be alive, which was defined as the latest among date of last visit, date of last sample collected for laboratory exam, date of magnetic resonance imaging (MRI) assessment, date of last treatment, date of discontinuation and date of last available follow-up visit. Participants with no information after baseline were censored at Day 1. OS was estimated by the Kaplan-Meier method.|6 months|Intent-to-Treat (ITT) population included all randomized participants with at least one administration of the study drug.||percentage of participants||95% Confidence Interval|Number
687763|NCT01474213|Secondary|Post Intubation Score|"Post-intubation was scored from 1 to 3, with higher scores indicating a worse outcome.
Post-intubation score 1 2 3
Cooperative, obeying commands
Uncomfortable, GA imminent
Other（specify）"|immediately after the intubation|||units on a scale||Inter-Quartile Range|Median
687764|NCT01474213|Primary|Intubation Score|graded from 0 to 5, with lower scores indicating better conditions Intubation score 0 1 2 3 4 5: 1)Grimacing when tube in nares 2)Localising with one limb at any stage 3)Localising with two limbs at any stage 4)Coughing on entering trachea 5)Prolonged coughing|during the inserting of the tracheal tube|Power calculation identified a minimum requirement of 15 patients randomized to each group to demonstrate a 20% difference in outcome scores with a power of 0.8 and a type I error of 0.05 according to our preliminary study.||units on a scale||Inter-Quartile Range|Median
687765|NCT01474213|Primary|Endoscopy Scores|"Endoscopy was graded from 0 to 5, with lower scores indicating a possibly better condition.
Endoscopy score 0 1 2 3 4 5: 1)Grimacing 2)localising 3)Coughing on lignocaine via scope 4)Coughing on entering infraglottic space 5)Prolonged coughing"|during the procedure of fibreoptic and tracheal intubation|Power calculation identified a minimum requirement of 15 patients randomized to each group to demonstrate a 20% difference in outcome scores with a power of 0.8 and a type I error of 0.05 according to our preliminary study.||units on a scale||Inter-Quartile Range|Median
687766|NCT01474213|Secondary|Cardiac Rhythm|Number of Participants with Abnormal Cardiac Rhythm(including any type of the abnormal cardiac rhythm from 15 minutes before intubation and during the intubation procedure was recorded such as sinus arrhythm, atrial or ventricular premature beats and atrioventricular block) was recorded.|15 minutes before intubation and duration of intubation|||participants|||Number
687767|NCT01474213|Secondary|Peripheral Oxygen Saturation(SPO2)|Peripheral oxygen saturation at 15 minutes before intuation, endoscopy point and intubation point between two groups were compared.|15 minutes before intubation, endoscopy point, intubation point|||percentage oxygen saturation||Standard Deviation|Mean
687768|NCT01474213|Secondary|Heart Rate|Heart rate at 15 minutes before intuation, endoscopy point and intubation point between two groups were compared.|15 minutes before intubation, endoscopy point, intubation point|||beats per minute||Standard Deviation|Mean
687769|NCT01474213|Secondary|Mean Arterial Blood Pressure|MAP at 15 minutes before intuation, endoscopy point and intubation point between two groups were compared.|15 minutes before intubation, endoscopy point, intubation point|||mmHg||Standard Deviation|Mean
687770|NCT01474213|Secondary|Post Operative Visit|visit the patients to ensure their memory of intubation. Postoperative interview asked the patients' memory of the fiberoptic intubation Amnesia Recall of endoscopy Yes No Recall of intubation Yes No The number is the patients who remember the operation procedure.|24 hours|||participants|||Number
687788|NCT01474200|Secondary|EFFICACY: Freedom From Congestion|Defined as jugular venous distention of < or equal to 8 cm, with no orthopnea, and with trace peripheral edema or no edema at hospital discharge|Index Hospitalization, an average of 8 days|||Participants|||Number
687789|NCT01474200|Secondary|EFFICACY: Time to Freedom From Congestion|Time from hospital admission to time patient is free of congestion in the hospital. Freedom from congestion is defined as jugular venous distention of < or equal to 8 cm, with no orthopnea and with trace peripheral edema or no edema. Measurement taken every 24 hours after treatment initiation.|Index Hospitalization, an average of 8 days|||Days||Standard Deviation|Mean
687771|NCT01474213|Secondary|Patient's Reaction to Procedure|"Ramsay score during the endoscopy intubation from 1 to 6. The higher scores means the deeper sedation level.
Clinical score Level of sedation
Patient is anxious and agitated or restless, or both
Patient is cooperative, oriented and tranquil
Patient responds to commands only
Patient exhibits a brisk response to a light glabellar (between the eyebrows) tap or loud auditory stimulus
Patient exhibits a sluggish response to a light glabellar tap or loud auditory stimulus
Patient exhibits no response to stimuli"|the duration of intubation, an expected average of 10 minutes|Power calculation identified a minimum requirement of 15 patients randomized to each group to demonstrate a 20% difference in outcome scores with a power of 0.8 and a type I error of 0.05 according to our preliminary study.||units on a scale||Inter-Quartile Range|Median
687772|NCT01474200|Secondary|SAFETY: Changes in Renal Function (Estimated Glomerular Filtration Rate) After Treatment up to 90 Days After Randomization|Changes in renal function prior to index treatment compared to various intervals by assessing the patient’s serum creatinine (sCr), Blood Urea Nitrogen(BUN), BUN/sCr ratio and estimated glomerular filtration rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) formula|Within 90 days of randomization|Number of participants analyzed changes over time. Discharge: n=105 for AQ arm, n=108 for LD arm. 30 days after discharge: n=93 for AQ arm, n=95 for LD arm. 60 days after discharge: n=85 for AQ arm, n=84 for LD arm. 90 days after discharge: n=4 for AQ arm, n=6 for LD arm.||mL/min/1.73m2||Standard Deviation|Mean
687773|NCT01474200|Secondary|SAFETY: Changes in Renal Function (Blood Urea Nitrogen/Serum Creatinine) After Treatment up to 90 Days After Randomization|Changes in renal function prior to index treatment compared to various intervals by assessing the patient’s serum creatinine (sCr), Blood Urea Nitrogen(BUN), BUN/sCr ratio and estimated glomerular filtration rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) formula|Within 90 days of randomization|Number of participants analyzed changes over time. Discharge: n=105 for AQ arm, n=108 for LD arm. 30 days after discharge: n=93 for AQ arm, n=95 for LD arm. 60 days after discharge: n=85 for AQ arm, n=84 for LD arm. 90 days after discharge: n=4 for AQ arm, n=6 for LD arm.||mg/dL||Standard Deviation|Mean
687774|NCT01474200|Secondary|SAFETY: Changes in Renal Function (Blood Urea Nitrogen) After Treatment up to 90 Days After Randomization|Changes in renal function prior to index treatment compared to various intervals by assessing the patient’s serum creatinine (sCr), Blood Urea Nitrogen(BUN), BUN/sCr ratio and estimated glomerular filtration rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) formula|Within 90 days of randomization|Number of participants analyzed changes over time. Baseline: n=105 for AQ arm, n=108 for LD arm. 30 days after discharge: n=93 for AQ arm, n=95 for LD arm. 60 days after discharge: n=85 for AQ arm, n=84 for LD arm. 90 days after discharge: n=4 for AQ arm, n=6 for LD arm.||mg/dL||Standard Deviation|Mean
687775|NCT01474200|Secondary|SAFETY: Changes in Renal Function (Serum Creatinine) After Treatment up to 90 Days After Randomization|Changes in renal function prior to index treatment compared to various intervals by assessing the patient’s serum creatinine (sCr), Blood Urea Nitrogen(BUN), BUN/sCr ratio and estimated glomerular filtration rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) formula|Within 90 days of randomization|Number of participants analyzed changes over time. Discharge: n=105 for AQ arm, n=108 for LD arm. 30 days after discharge: n=93 for AQ arm, n=95 for LD arm. 60 days after discharge: n=85 for AQ arm, n=84 for LD arm. 90 days after discharge: n=4 for AQ arm, n=6 for LD arm.||mg/dL||Standard Deviation|Mean
687776|NCT01474200|Secondary|CLINICAL: Global Clinical Score at 30 and 90 Days After Discharge|KCCQ Questionnaire analysis based on patient's self-assessment of how they feel at various intervals compared to how they felt prior to index treatment. Scores were transformed to a range of 0-100, in which higher scores reflect better health status.|Within 90 days after hospital discharge|Number of participants analyzed changes over time. Baseline: n=107 for AQ arm, n=110 for LD arm. 30 day follow up: n=85 for AQ arm, n=92 for LD arm. 90 day follow up: n=72 for AQ arm, n=77 for LD arm.||Scores on a Scale||Standard Deviation|Mean
687777|NCT01474200|Secondary|CLINICAL: Quality of Life Assessed Using the Kansas City Cardiomyopathy Questionnaire (KCCQ) at 30, 60 and 90 Days After Discharge|Questionnaire assessed patients quality of life prior to index treatment versus timeframes following hospital discharge. Scores were transformed to a range of 0-100, in which higher scores reflect better health status.|Within 90 days after hospital discharge|Number of participants analyzed changes over time. Baseline: n=107 for AQ arm, n=110 for LD arm. 30 day follow up: n=85 for AQ arm, n=91 for LD arm. 90 day follow up: n=72 for AQ arm, n=77 for LD arm.||Scores on a Scale||Standard Deviation|Mean
687778|NCT01474200|Secondary|CLINICAL: Days Alive and Out of Hospital at 30 and 90 Days After Discharge|Number of days patients were alive and out of the hospital.|Within 30 and 90 days after hospital discharge|||Days||Standard Deviation|Mean
687779|NCT01474200|Secondary|CLINICAL: Mortality Rates Within Index Hospitalization or Within 90 Days After Hospital Discharge.|Death due to any cause.|Time from randomization to 90 days post-hospital discharge|||Percentage of Participants|||Number
687780|NCT01474200|Secondary|CLINICAL: All Cause Rehospitalization Rates at 30 and 90 Days|Any cause that required hospitalization for treatment within 90 days of index hospitalization discharge.|Within 30 days and 90 days after hospital discharge|||Rehospitalizations/100 Pt-Days at Risk|||Number
687781|NCT01474200|Secondary|CLINICAL: Total Number of Days for Cardiovascular (CV) Rehospitalizations at 30 and 90 Days After Discharge|The total number of days spent in the hospital due to CV related events at 30 days and 90 days from hospital discharge.|Within 30 days and 90 days after hospital discharge|||Days|||Number
687782|NCT01474200|Secondary|CLINICAL: Total Number of Cardiovascular (CV) Rehospitalizations at 30 and 90 Days After Discharge|CV symptoms that required hospitalization for treatment within 90 days of index hospitalization discharge.|Within 30 days and 90 days after hospital discharge|||Rehospitalizations|||Number
687783|NCT01474200|Secondary|CLINICAL: Total Number of Heart Failure (HF) Rehospitalizations at 30 and 90 Days After Discharge|Number of different times patient was admitted to hospital for HF symptoms within 90 days of index hospitalization discharge.|Within 30 days and 90 days after hospital discharge|||Rehospitalizations|||Number
687784|NCT01474200|Secondary|CLINICAL: Total Number of Emergency Department (ED) or Unscheduled Office Visits at 30 and 90 Days After Discharge|Number of visits for HF symptoms requiring ED or clinic treatment involving the use of IV diuretics and /or positive inotropic or vasodilator drugs|Within 30 days and 90 days after hospital discharge|||Visits|||Number
687984|NCT01472822|Secondary|Changes in OSC(Osteocalcin)|OSC(Osteocalcin) was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis||ng/ml||Standard Deviation|Mean
687795|NCT01474122|Secondary|Change in Hand Functionality - Hand Disability in Systemic Sclerosis – Digital Ulcers (HDISS-DU) Score From Baseline to Week 16|Patients were asked to answer 24 questions on the use of the hand(s) affected by DUs over the past 7 days on a 6-point scale from 0 (yes without difficulty) to 5 (impossible). The HDISS-DU score is the arithmetic mean of the valid non-missing items. The scores are interpreted as 1 (better ability in completing activities) to 6 (worst ability in completing activities)|Baseline to Week 16|Modified intention to treat set. Ten patients were excluded from the modified intent to treat set due to protocol violations.||Units on a scale||Standard Deviation|Mean
687796|NCT01474122|Secondary|Health Assessment Questionnaire – Disability Index (HAQ-DI) Overall Score From Baseline to Week 16|HAQ-DI assesses functional ability regarding fine movements of the upper extremities, locomotor activities in the lower extremities, and movements of the upper and lower limbs. Responses were extracted from the Scleroderma Health Assessment Questionnaire covering 8 domains of functional disability (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other daily activities). A mean score ranging from 0-3 was calculated for each domain, and a composite score by dividing the summed domain scores by the number of domains. The composite score was interpreted as 0 (no impairment in function) to 3 (maximal impairment of function).|Baseline to Week 16|Modified intention to treat set. Ten patients were excluded from the modified intent to treat set due to protocol violations.||Units on a scale||Standard Deviation|Mean
687797|NCT01474122|Secondary|Change in Hand Functionality Health Assessment Questionnaire – Disability Index (HAQ-DI) Hand Component From Baseline to Week 16|HAQ-DI assesses functional ability regarding fine movements of the upper extremities, locomotor activities in the lower extremities, and movements of the upper and lower limbs. Responses were extracted from the Scleroderma Health Assessment Questionnaire covering 8 domains of functional disability (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other daily activities). A mean score ranging from 0-3 was calculated for each domain, and a composite score by dividing the summed domain scores by the number of domains. The composite score was interpreted as 0 (no impairment in function) to 3 (maximal impairment of function). Hand functionality was assessed using a composite of 4 domains (dressing and grooming, grip, hygiene, and eating).|Baseline to Week 16|Modified intention to treat set. Ten patients were excluded from the modified intent to treat set due to protocol violations.||Units on a scale||Standard Deviation|Mean
687798|NCT01474122|Secondary|Percentage of Participants With at Least One DU Complication|"DU complications were defined as any one of the following:
resulting from DU worsening: critical ischemic crisis necessitating hospitalization; gangrene, (auto)amputation; failure of conservative management; surgical and chemical sympathectomy, vascular reconstructions, or any unplanned surgery in the management of hand SSc manifestations; use of parenteral prostanoids; use of endothelin-receptor antagonists; class II, III, or IV narcotics or a > 50% increase in the existing dose compared with baseline; initiation of systemic antibiotics for the treatment of infection attributed to DUs."|Up to 95 weeks|Modified intention to treat set. Ten patients were excluded from the modified intent to treat set due to protocol violations.||Percentage of participants|||Number
687799|NCT01474122|Secondary|Percentage of Participants Without a New DU up to Week 16|DUs were assessed at each visit starting with the screening visit. Only DUs from the proximal interphalangeal joint (PIP) distally (both on the dorsal and volar surface of the hand, including the digital tip) were recorded. The location of each DU was noted. At each subsequent visit the location of each new DU was noted. DUs that occurred and healed between visits and were reported by patients were not recorded as new DUs. The evaluation was performed by an experienced physician or a trained rater with expertise in the assessment of DUs in systemic sclerosis (SSc). For a given patient, DUs were assessed by the same rater at each visit, whenever possible. Any DU that developed over a previously healed ulcer was recorded as a new DU. Numbers of patients with no new DU at Week 16 are imputed using the last observation carried forward method.|Baseline to Week 16|Modified intention to treat set. Ten patients were excluded from the modified intent to treat set due to protocol violations.||Percentage of participants|||Number
687800|NCT01474122|Primary|Incidence Rate of New Digital Ulcers (DUs) up to Week 16|DUs were assessed at each visit starting with the screening visit. Only DUs from the proximal interphalangeal joint (PIP) distally (both on the dorsal and volar surface of the hand, including the digital tip) were recorded. The location of each DU was noted. At each subsequent visit the location of each new DU was noted. DUs that occurred and healed between visits and were reported by patients were not recorded as new DUs. The evaluation was performed by an experienced physician or a trained rater with expertise in the assessment of DUs in systemic sclerosis (SSc). For a given patient, DUs were assessed by the same rater at each visit, whenever possible. Any DU that developed over a previously healed ulcer was recorded as a new DU. Incidence rate is adjusted for 16 weeks of observation, hence is calculated as the number of new DUs/total number of observation days.|Baseline to Week 16|Full analysis set||new DUs/16 weeks|||Number
687801|NCT01474109|Secondary|Change in Hand Functionality - Hand Disability in Systemic Sclerosis – Digital Ulcers (HDISS-DU) Score From Baseline to Week 16|Patients were asked to answer 24 questions on the use of the hand(s) affected by DUs over the past 7 days on a 6-point scale from 0 (yes without difficulty) to 5 (impossible). The HDISS-DU score is the arithmetic mean of the valid non-missing items. The scores are interpreted as 1 (better ability in completing activities) to 6 (worst ability in completing activities)|Baseline to week 16|Modified intention-to-treat set. Eleven patients were excluded from the modified intent-treat set due to protocol violations.||units on a scale||Standard Deviation|Mean
687802|NCT01474109|Secondary|Health Assessment Questionnaire – Disability Index (HAQ-DI) Overall Score From Baseline to Week 16|HAQ-DI assesses functional ability regarding fine movements of the upper extremities, locomotor activities in the lower extremities, and movements of the upper and lower limbs. Responses were extracted from the Scleroderma Health Assessment Questionnaire covering 8 domains of functional disability (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other daily activities). A mean score ranging from 0-3 was calculated for each domain, and a composite score by dividing the summed domain scores by the number of domains. The composite score was interpreted as 0 (no impairment in function) to 3 (maximal impairment of function).|Baseline to week 16|Modified intention-to-treat set. Eleven patients were excluded from the modified intent-treat set due to protocol violations.||units on a scale||Standard Deviation|Mean
687985|NCT01472822|Secondary|Changes in Hs-CRP(High Sensitivity C-reactive Protein)|hs-CRP(high sensitivity C-reactive protein) was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis||mg/L||Standard Deviation|Mean
687803|NCT01474109|Secondary|Change in Hand Functionality Health Assessment Questionnaire – Disability Index (HAQ-DI) Hand Component From Baseline to Week 16|HAQ-DI assesses functional ability regarding fine movements of the upper extremities, locomotor activities in the lower extremities, and movements of the upper and lower limbs. Responses were extracted from the Scleroderma Health Assessment Questionnaire covering 8 domains of functional disability (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other daily activities). A mean score ranging from 0-3 was calculated for each domain, and a composite score by dividing the summed domain scores by the number of domains. The composite score was interpreted as 0 (no impairment in function) to 3 (maximal impairment of function). Hand functionality was assessed using a composite of 4 domains (dressing and grooming, grip, hygiene, and eating).|Baseline to week 16|Modified intention-to-treat set. Eleven patients were excluded from the modified intent-treat set due to protocol violations.||units on a scale||Standard Deviation|Mean
687804|NCT01474109|Secondary|Percentage of Participants With at Least One DU Complication|DU complications were defined as any one of the following, resulting from DU worsening: critical ischemic crisis necessitating hospitalization; gangrene, (auto)amputation; failure of conservative management; surgical and chemical sympathectomy, vascular reconstructions, or any unplanned surgery in the management of hand SSc manifestations; use of parenteral prostanoids; use of endothelin-receptor antagonists; class II, III, or IV narcotics or a > 50% increase in the existing dose compared with baseline; initiation of systemic antibiotics for the treatment of infection attributed to DUs.|Up to approximately 90 weeks|Modified intent-to-treat set. Eleven patients were excluded from the modified intent-treat set due to protocol violations.||percentage of participants|||Number
687805|NCT01474109|Secondary|Percentage of Participants Without a New DU Up To Week 16|DUs were assessed at each visit starting with the screening visit. Only DUs from the proximal interphalangeal joint (PIP) distally (both on the dorsal and volar surface of the hand, including the digital tip) were recorded. The location of each DU was noted. At each subsequent visit the location of each new DU was noted. DUs that occurred and healed between visits and were reported by patients were not recorded as new DUs. The evaluation was performed by an experienced physician or a trained rater with expertise in the assessment of DUs in systemic sclerosis (SSc). For a given patient, DUs were assessed by the same rater at each visit, whenever possible. Any DU that developed over a previously healed ulcer was recorded as a new DU. Numbers of patients with no new DU at Week 16 are imputed using the last observation carried forward method.|Baseline to week 16|Modified intent-to-treat set. Eleven patients were excluded from the modified intent-treat set due to protocol violations.||Percentage of participants|||Number
687806|NCT01474109|Primary|Incidence Rate of New Digital Ulcers (DUs) up to Week 16|DUs were assessed at each visit starting with the screening visit. Only DUs from the proximal interphalangeal joint (PIP) distally (both on the dorsal and volar surface of the hand, including the digital tip) were recorded. The location of each DU was noted. At each subsequent visit the location of each new DU was noted. DUs that occurred and healed between visits and were reported by patients were not recorded as new DUs. The evaluation was performed by an experienced physician or a trained rater with expertise in the assessment of DUs in systemic sclerosis (SSc). For a given patient, DUs were assessed by the same rater at each visit, whenever possible. Any DU that developed over a previously healed ulcer was recorded as a new DU. Incidence rate is adjusted for 16 weeks of observation, hence is calculated as the number of new DUs/total number of observation days.|Baseline to week 16|Full analysis set||number of new DUs/observation days|||Number
687807|NCT01473992|Primary|Physical Functional Performance (Continuous Scale; 10-items)|Simulation of 10 activities of daily living (i.e. donning a shirt, sweeping, walking stairs). Measured in units of time, distance and mass to provide a singular, continuous scaled score of function (from 0-100). A score of 100 is the maximal score and indicates the highest level of independent function where a score of 0 indicates the poorest score. Persons scoring lower scores will likely be at increased risk of dependency with daily function.|Accommodation with knee systems is approximately 90 days. This test takes less than 1hr to complete.|||scores on a scale||Standard Deviation|Mean
687808|NCT01473992|Secondary|Prosthesis Evaluation Questionnaire: Utility Score.|The Prosthetics Evaluation Questionnaire (PEQ) was used as a validated survey to solicit participants' subjective experience and feedback regarding prosthesis-related function and quality of life. PEQ domains are ordinally scaled from 0 (worst or most negative feeling/response) to 7 (best or most positive feeling/response).|Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.|||score on a scale||Full Range|Median
687809|NCT01473992|Secondary|Balance and Stability|Balance and stability will be assessed for limits of stability using the Biodex SD. The limit of stability score is a scaled score with a possible range of 0 (worst possible outcome) to 100 (best possible outcome)based on variability of the trajectory of the center of mass while weight shifting on a force platform.|Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.|||scores on a scale||Standard Deviation|Mean
687810|NCT01473992|Primary|75 Meter Self Selected Walking Test|Time to Complete a 75 meter walking distance.|Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.|||seconds||Standard Deviation|Mean
687811|NCT01473953|Secondary|Number of Subjects With Antibodies (Positive) or Without Antibodies (Negative) Against Liraglutide Observed at Pre-dose and at Last Follow-up||Day 0 and Day 21|The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation ‘as treated’.||participants|||Number
687812|NCT01473953|Secondary|Area Under the Plasma Concentration Curve in the First Week Following Liraglutide-depot Administration for Subjects With Liraglutide 6 mg/ml Pre-treatment||0 to 168 hours after dosing|Full analysis set consisted of all subjects who were randomised and exposed to randomised treatment. Cohorts with liraglutide pre-treatment were not initiated based on review of pharmacokinetic data, and hence no analysis was done.|||||
687954|NCT01473160|Secondary|Subjective Vision|"Overall vision was assessed by the participant on scale from 0 (poor) to 10 (excellent) in response to the question, What is the quality of your vision with the lens at present?"|Up to 16 hours after lens insertion|All enrolled participants||Units on a scale||Standard Deviation|Mean
688217|NCT01468337|Secondary|Changes in Mean Macular Sensitivity as Assessed by Microperimetry at Week 2 Compared to Baseline||Baseline and Week 2||||||
687813|NCT01473953|Secondary|Area Under the Liraglutide Plasma Concentration Curve in the First Week Following Liraglutide-depot Administration for Subjects Without Liraglutide 6 mg/ml Pre-treatment||1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168 hours post dose|Full analysis set consisted of all subjects who were randomised and exposed to randomised treatment. 1 subject was not included for this evaluation in the cohort 1a arm due to insufficient data. Cohorts with liraglutide pre-treatment were not initiated based on review of pharmacokinetic data, and hence no analysis was done.||pmol.h/L||Geometric Coefficient of Variation|Geometric Mean
687814|NCT01473953|Secondary|Area Under the Plasma Concentration Curve in the Period From the Time of Liraglutide-depot Administration to Infinity||Day 0 through day 21 at 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168, 336, 504 hours post dose|Full analysis set consisted of all subjects who were randomised and exposed to randomised treatment. 1 subject was not included for this evaluation in the cohort 1a arm due to insufficient data. This evaluation was not done on placebo cohort.||pmol.h/L||Geometric Coefficient of Variation|Geometric Mean
687815|NCT01473953|Secondary|Time to Maximum Plasma Concentration of Liraglutide After a Single Dose of Liraglutide-depot||Day 0 through day 21 at 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168, 336, 504 hours post dose|Full analysis set consisted of all subjects who were randomised and exposed to randomised treatment. This evaluation was not done on placebo cohort.||hours||Geometric Coefficient of Variation|Geometric Mean
687816|NCT01473953|Secondary|Maximum Plasma Concentration of Liraglutide After a Single Dose of Liraglutide-depot||Day 0 through day 21 at 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168, 336, 504 hours post dose|Full analysis set consisted of all subjects who were randomised and exposed to randomised treatment. This evaluation was not done on placebo cohort.||pmol/L||Geometric Coefficient of Variation|Geometric Mean
687817|NCT01473953|Primary|Number of Treatment Emergent Adverse Events (TEAEs)|TEAEs: AEs from 1st exposure (exp) until follow-up (FU) or AEs with onset before 1st exp increasing in severity up to the FU. Mild AEs: no or transient symptoms, no interference (inf) with subject's daily activities. Moderate AEs: marked symptoms, moderate inf with subject's daily activities. Severe AEs: considerable inf with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in death/ a life-threatening experience/ in-subject hospitalization/prolongation of existing hospitalisation; or persistent/significant disability/incapacity/congenital anomaly/birth defect.|Day 0 and up to 21 days after treatment|The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation ‘as treated’.||events|||Number
687818|NCT01473836|Secondary|Number of Participants Analyzed for Population Pharmacokinetics (PK) of Metronidazole|Population pharmacokinetic analysis of Metronidazole is conducted by combining current study data with other Metronidazole studies.|Four samples were taken at any infusion after the first dosing: during infusion, immediately after end of infusion, between 15 and 60 minutes after end of infusion, and between 2 hours and immediately before the start of the next infusion.|No population pharmacokinetic analysis results are available just for the current study.|||||
687819|NCT01473836|Secondary|Bacteriological Response: Eradication Rate (Investigator Assessment)|"Bacteriological response was evaluated as eradication (eradication, presumed eradication or colonization), persistence, or indeterminate by the investigator at the end of treatment (EOT), and the test of cure (TOC: 7 days after EOT). Eradication Rate was calculated from the following formula, number of participants with bacteria eradication, presumed eradication or colonization over total number of participants that excluding ones evaluated as indeterminate multiplied by 100."|Baseline to Day 4, EOT (up to 14 days), TOC|"Bacteriologic per protocol set consisted of all participants in the clinical per protocol set in whom bacterial pathogens were identified on Day 1 prior to the initial dose. No imputation was used for missing data. n = number of participants assessed that excluding ones evaluated as indeterminate."||percentage of participants||95% Confidence Interval|Number
687820|NCT01473836|Secondary|Bacteriological Response: Eradication Rate (Data Review Committee Assessment)|"Bacteriological response was evaluated as eradication (eradication, presumed eradication or colonization), persistence, or indeterminate by the data review committee, at Day 4, at the end of treatment (EOT), and the test of cure (TOC: 7 days after EOT). Eradication Rate was calculated from the following formula, number of participants with bacteria eradication, presumed eradication or colonization over total number of participants that excluding ones evaluated as indeterminate multiplied by 100."|Baseline to Day 4, EOT (up to 14 days), TOC|"Bacteriologic per protocol set consisted of all participants in the clinical per protocol set in whom bacterial pathogens were identified on Day 1 prior to the initial dose. No imputation was used for missing data. n = number of participants assessed that excluding ones evaluated as indeterminate."||percentage of participants||95% Confidence Interval|Number
687821|NCT01473836|Secondary|Percentage of Participants Who Was Assessed as Appropriate to Continue Treatment (Investigator Assessment)|"The appropriateness of treatment continuation was evaluated on Day 4 by the investigator as continuation, discontinuation or indeterminate based on the clinical response. The percentage of participants was calculated from the following formula; number of participants assessed as continuation over total number of participants that excluding ones assessed as indeterminate multiplied by 100."|Baseline to Day 4|"Clinical per protocol set consisted of all participants who received at least one dose of study medication, had no significant protocol deviation, and underwent planned assessments. No imputation was used for missing data. n = number of participants assessed that excluding ones evaluated as indeterminate."||percentage of participants|||Number
687830|NCT01473758|Secondary|Change From Stable State in Diaries Treatment Score Weekly Average (Extended Approach)|Any changes in the participant’s usual treatment were recorded in a daily diary. Diaries Symptom Score range from 0 to 100, with higher scores indicating worse health status. A negative change from Baseline indicates improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are stable state value, treatment, time point, and treatment by time point interaction.|Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.||score on a scale||Standard Error|Least Squares Mean
687955|NCT01473160|Secondary|Subjective Comfort|"Overall comfort was assessed by the participant and recorded on a scale from 0 (poor) to 10 (excellent) in response to the question, How comfortable is the lens feeling at present?"|Up to 16 hours after lens insertion|All enrolled participants||Units on a scale||Standard Deviation|Mean
710424|NCT00161382|Secondary|Communication With Parents||Measured throughout the study||||||
687822|NCT01473836|Secondary|Clinical Response: Response Rate (Investigator Assessment)|"Clinical response was evaluated by the investigator as effective (cured or improved), ineffective (not meeting effective” criteria), or indeterminate at the end of treatment (EOT) and the test of cure (TOC: 7 days after EOT) based on clinical symptoms, ultrasound images and necessity of other treatment. TOC was the primary analysis of this outcome measure. Cured = clinical symptoms and abnormal findings at the start of the study were disappeared and considered other antibiotics were not required during the study and after the assessment time point. Improved = clinical symptoms and abnormal findings at the start of the study were improved and considered other antibiotics were not required during the study and after the assessment time point. Response rate was calculated from the following formula; number of participants evaluated as effective over total number of participants that excluding ones evaluated as indeterminate multiplied by 100."|Baseline to EOT (up to 14 days), TOC|"Clinical per protocol set consisted of all participants who received at least one dose of study medication, had no significant protocol deviation, and underwent planned assessments. No imputation was used for missing data. n = number of participants assessed that excluding ones evaluated as indeterminate."||percentage of participants||95% Confidence Interval|Number
687823|NCT01473836|Primary|Clinical Response: Response Rate (Data Review Committee Assessment)|"Clinical response was evaluated by the data review committee as effective (cured or improved), ineffective (not meeting effective” criteria), or indeterminate at the end of treatment (EOT) and the test of cure (TOC: 7 days after EOT) based on clinical symptoms, ultrasound images and necessity of other treatment. TOC was the primary analysis of this outcome measure. Cured = clinical symptoms and abnormal findings at the start of the study were disappeared and considered other antibiotics were not required during the study and after the assessment time point. Improved = clinical symptoms and abnormal findings at the start of the study were improved and considered other antibiotics were not required during the study and after the assessment time point. Response rate was calculated from the following formula; number of participants evaluated as effective over total number of participants that excluding ones evaluated as indeterminate multiplied by 100."|Baseline to EOT (up to 14 days), TOC|"Clinical per protocol set consisted of all participants who received at least one dose of study medication, had no significant protocol deviation, and underwent planned assessments. No imputation was used for missing data. n = number of participants assessed that excluding ones evaluated as indeterminate."||percentage of participants||95% Confidence Interval|Number
687824|NCT01473758|Secondary|Change From Baseline in Aortic Pulse Wave Velocity in a Subset of Participants (Extended Approach)|Carotid-femoral aortic pulse wave velocity (aPWV) will be measured in a subset of participants to determine changes in arterial stiffness. A negative change from Baseline indicates improvement. Covariates for MMRM are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Days 14 and 28|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.||meters/second||Standard Error|Least Squares Mean
687825|NCT01473758|Secondary|Change From Baseline in Aortic Pulse Wave Velocity in a Subset of Participants (Initial Approach)|Carotid-femoral aortic pulse wave velocity (aPWV) will be measured in a subset of participants to determine changes in arterial stiffness. A negative change from Baseline indicates improvement. Covariates for MMRM are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Days 14 and 28|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.||meters/second||Standard Error|Least Squares Mean
687826|NCT01473758|Secondary|Exacerbation Length (Extended Approach)|Exacerbation length is the period from start of increased symptoms to end of increased symptoms; the last day of an exacerbation was to be followed by 2 days without symptom entries in the diary.|8 Weeks|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.||days||95% Confidence Interval|Median
687827|NCT01473758|Secondary|Exacerbation Length (Initial Approach)|Exacerbation length is the period from start of increased symptoms to end of increased symptoms; the last day of an exacerbation was to be followed by 2 days without symptom entries in the diary.|8 Weeks|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.||days||95% Confidence Interval|Median
687828|NCT01473758|Secondary|Change From Stable State in Diaries Hours Out of the Home Weekly Average (Extended Approach)|Estimates of the length of time the participants were out of their own home on the previous day were recorded in a daily diary. A negative change from Baseline indicates improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are stable state value, treatment, time point, and treatment by time point interaction.|Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.||hours||Standard Error|Least Squares Mean
687829|NCT01473758|Secondary|Change From Stable State in Diaries Hours Out of the Home Weekly Average (Initial Approach)|Estimates of the length of time the participants were out of their own home on the previous day were recorded in a daily diary. A negative change from Baseline indicates improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are stable state value, treatment, time point, and treatment by time point interaction.|Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.||hours||Standard Error|Least Squares Mean
687904|NCT01473589|Secondary|Mean Change From Baseline to 6 Months in Worst Fracture-Site Pain|The worst pain NRS was used to assess the impact of pain on a participant's life. Participants with an NRS score of <7 were categorized as having no severe fracture-site pain. Least Squares (LS) means was calculated using analysis of covariance (ANCOVA) and adjusted for baseline, treatment group, region, fracture type, and fixation type.|Baseline, 6 Months|Participants who were randomized and received at least 1 dose of study drug and had baseline and at least 1 nonmissing post-baseline measurement.||units on a scale||Standard Error|Least Squares Mean
687831|NCT01473758|Secondary|Change From Stable State in Diaries Treatment Score Weekly Average (Initial Approach)|Any changes in the participant’s usual treatment were recorded in a daily diary. Diaries Symptom Score range from 0 to 100, with higher scores indicating worse health status. A negative change from Baseline indicates improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are stable state value, treatment, time point, and treatment by time point interaction.|Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.||score on a scale||Standard Error|Least Squares Mean
687832|NCT01473758|Secondary|Change From Stable State in Diaries Symptom Score Weekly Average (Extended Approach)|Any increase in the following respiratory symptoms: dyspnea, sputum purulence, sputum amount, wheeze, sore throat, cough, fever, symptoms of a common cold, ie, nasal congestion and discharge over the previous 24 hours were recorded in a daily diary. Diaries Symptom Score range from 0 to 100, with higher scores indicating worse health status. A negative change from Baseline indicates improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are stable state value, treatment, time point, and treatment by time point interaction.|Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.||score on a scale||Standard Error|Least Squares Mean
687833|NCT01473758|Secondary|Change From Stable State in Diaries Symptom Score Weekly Average (Initial Approach)|Any increase in the following respiratory symptoms: dyspnea, sputum purulence, sputum amount, wheeze, sore throat, cough, fever, symptoms of a common cold, ie, nasal congestion and discharge over the previous 24 hours were recorded in a daily diary. Diaries Symptom Score range from 0 to 100, with higher scores indicating worse health status. A negative change from Baseline indicates improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are stable state value, treatment, time point, and treatment by time point interaction.|Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.||score on a scale||Standard Error|Least Squares Mean
687834|NCT01473758|Secondary|Change From Stable State in Diaries Peak Expiratory Flow (PEF) Weekly Average (Extended Approach)|Morning post-medication PEF (the best of 3 attempts measured with a mini-Wright peak-flow meter) was recorded in a daily diary. A positive change from Baseline indicates improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are stable state value, treatment, time point, and treatment by time point interaction.|Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.||liters/minute||Standard Error|Least Squares Mean
687835|NCT01473758|Secondary|Change From Stable State in Diaries Peak Expiratory Flow (PEF) Weekly Average (Initial Approach)|Morning post-medication PEF (the best of 3 attempts measured with a mini-Wright peak-flow meter) was recorded in a daily diary. A positive change from Baseline indicates improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are stable state value, treatment, time point, and treatment by time point interaction.|Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.||liters/minute||Standard Error|Least Squares Mean
687836|NCT01473758|Secondary|Change From Stable State in Exacerbations of Chronic Pulmonary Disease Test (EXACT-PRO) Weekly Averages (Extended Approach)|The EXACT-PRO questionnaire is a new, validated, and standardized measure to evaluate the frequency, severity, and duration of COPD exacerbations. It is a 14-item daily diary, and scores range from 0 to 100, with higher scores indicating worse health status. A negative change from Baseline indicates improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, time point, treatment by time point and baseline by time point interaction.|Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.||scores on a scale||Standard Error|Least Squares Mean
687837|NCT01473758|Secondary|Change From Stable State in Exacerbations of Chronic Pulmonary Disease Test (EXACT-PRO) Weekly Averages (Initial Approach)|The EXACT-PRO questionnaire is a new, validated, and standardized measure to evaluate the frequency, severity, and duration of COPD exacerbations. It is a 14-item daily diary, and scores range from 0 to 100, with higher scores indicating worse health status. A negative change from Baseline indicates improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, time point, treatment by time point and baseline by time point interaction.|Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.||score on a scale||Standard Error|Least Squares Mean
687838|NCT01473758|Secondary|Exacerbations of Chronic Pulmonary Disease Test (EXACT-PRO) Weekly Averages (Extended Approach)|The EXACT-PRO questionnaire is a new, validated, and standardized measure to evaluate the frequency, severity, and duration of COPD exacerbations. It is a 14-item daily diary, and scores range from 0 to 100, with higher scores indicating worse health status.|Weeks 1, 2, 3, 4, 5, 6, 7 and 8|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.||score on a scale||Standard Deviation|Mean
687839|NCT01473758|Secondary|Exacerbations of Chronic Pulmonary Disease Test (EXACT-PRO) Weekly Averages (Initial Approach)|The EXACT-PRO questionnaire is a new, validated, and standardized measure to evaluate the frequency, severity, and duration of COPD exacerbations. It is a 14-item daily diary, and scores range from 0 to 100, with higher scores indicating worse health status.|Weeks 1, 2, 3, 4, 5, 6, 7 and 8|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.||score on a scale||Standard Deviation|Mean
687840|NCT01473758|Secondary|Change From Stable State in Chronic Obstructive Pulmonary Assessment Test (CAT) Weekly Averages (Extended Approach)|The CAT is a short, validated, patient-completed questionnaire to assess the impact of COPD on health status. It comprises 8 questions that cover a broad range of effects of COPD on patients' health. Each question is scored in a range between 0 and 5, with the higher end indicating a higher impact of COPD on the patient's wellbeing. The CAT Total score ranges from 0 best) to 40 (Worst). A negative change from Baseline indicates improvement. Covariates for MMRM are stable state value, treatment, time point, and treatment by time point interaction.|Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.||scores on a scale||Standard Error|Least Squares Mean
687841|NCT01473758|Secondary|Change From Stable State in Chronic Obstructive Pulmonary Assessment Test (CAT) Weekly Averages (Initial Approach)|The CAT is a short, validated, patient-completed questionnaire to assess the impact of COPD on health status. It comprises 8 questions that cover a broad range of effects of COPD on patients’ health. Each question is scored in a range between 0 and 5, with the higher end indicating a higher impact of COPD on the patient’s wellbeing. The CAT Total score ranges from 0 best) to 40 (Worst). A negative change from Baseline indicates improvement. Covariates for MMRM are stable state value, treatment, time point, and treatment by time point interaction.|Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.||score on a scale||Standard Error|Least Squares Mean
687842|NCT01473758|Secondary|Chronic Obstructive Pulmonary Assessment Test (CAT) Weekly Averages (Extended Approach)|The CAT is a short, validated, patient-completed questionnaire to assess the impact of COPD on health status. It comprises 8 questions that cover a broad range of effects of COPD on patients’ health. Each question is scored in a range between 0 and 5, with the higher end indicating a higher impact of COPD on the patient’s wellbeing. The CAT Total score ranges from 0 best) to 40 (Worst).|Weeks 1, 2, 3, 4, 5, 6, 7 and 8|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.||score on a scale||Standard Deviation|Mean
687843|NCT01473758|Secondary|Chronic Obstructive Pulmonary Assessment Test (CAT) Weekly Averages (Initial Approach)|The CAT is a short, validated, patient-completed questionnaire to assess the impact of COPD on health status. It comprises 8 questions that cover a broad range of effects of COPD on patients’ health. Each question is scored in a range between 0 and 5, with the higher end indicating a higher impact of COPD on the patient’s wellbeing. The CAT Total score ranges from 0 best) to 40 (Worst).|Weeks 1, 2, 3, 4, 5, 6, 7 and 8|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.||score on a scale||Standard Deviation|Mean
687844|NCT01473758|Secondary|Change From Baseline in FEV1/FVC (Extended Approach)|FEV1/FVC is the percentage of the vital capacity which is expired in the first second of maximal expiration. In healthy patients the FEV1/FVC is usually around 70%. A positive change from Baseline indicates an improvement. A Mixed Model Repeated Measurement (MMRM) was used for analysis with Baseline value, treatment, visit, and treatment by visit interaction as covariates.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.||percent||Standard Error|Least Squares Mean
687845|NCT01473758|Secondary|Change From Baseline in FEV1/FVC (Initial Approach)|FEV1/FVC is the percentage of the vital capacity which is expired in the first second of maximal expiration. In healthy patients the FEV1/FVC is usually around 70%. A positive change from Baseline indicates an improvement. A Mixed Model Repeated Measurement (MMRM) was used for analysis with Baseline value, treatment, visit, and treatment by visit interaction as covariates.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.||percent||Standard Error|Least Squares Mean
687846|NCT01473758|Secondary|Change From Baseline in Forced Vital Capacity (FVC) (Extended Approach)|Forced vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Pulmonary function testing was performed using spirometry. A positive change from Baseline indicates an improvement. A Mixed Model Repeated Measurement (MMRM) was used for analysis with Baseline value, treatment, visit, and treatment by visit interaction as covariates.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.||liters||Standard Error|Least Squares Mean
687847|NCT01473758|Secondary|Change From Baseline in Forced Vital Capacity (FVC) (Initial Approach)|Forced vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Pulmonary function testing was performed using spirometry. A positive change from Baseline indicates an improvement. A Mixed Model Repeated Measurement (MMRM) was used for analysis with Baseline value, treatment, visit, and treatment by visit interaction as covariates.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.||liters||Standard Error|Least Squares Mean
687937|NCT01473524|Secondary|Composite Endpoint Alkaline Phosphatase and Total Bilirubin, 10 mg vs. Placebo|Proportion of subjects at Month 6 with ALP < 1.67x ULN and total bilirubin ≤ ULN and ALP decrease of ≥ 15% from baseline.|6 months|Intent-to-Treat Population||percentage of participants|||Number
687938|NCT01473524|Primary|Composite Endpoint Alkaline Phosphatase and Total Bilirubin, 10 mg OCA vs. Placebo|Proportion of subjects at Month 12 with ALP < 1.67x ULN and total bilirubin ≤ ULN and ALP decrease of ≥ 15% from baseline.|12 months|Intent-to-Treat Population||percentage of participants|||Number
710425|NCT00161382|Secondary|Barriers||Measured throughout the study||||||
687848|NCT01473758|Secondary|Change From Baseline in Forced Expiratory Volume (FEV1) (Extended Approach)|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Pulmonary function testing was performed using spirometry. A positive change from Baseline indicates an improvement. A Mixed Model Repeated Measurement (MMRM) was used for analysis with Baseline value, treatment, visit, and treatment by visit interaction as covariates.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.||liters||Standard Error|Least Squares Mean
687849|NCT01473758|Secondary|Change From Baseline in Forced Expiratory Volume (FEV1) (Initial Approach)|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Pulmonary function testing was performed using spirometry. A positive change from Baseline indicates an improvement. A Mixed Model Repeated Measurement (MMRM) was used for analysis with Baseline value, treatment, visit, and treatment by visit interaction as covariates.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.||liters||Standard Error|Least Squares Mean
687850|NCT01473758|Secondary|Change From Baseline in Blood Biomarker Glucose (Extended Approach)|Blood was collected and analyzed for serum glucose levels. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.||mmol/L||Standard Error|Least Squares Mean
687851|NCT01473758|Secondary|Change From Baseline in Blood Biomarker Glucose (Initial Approach)|Blood was collected and analyzed for serum glucose levels. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.||mmol/L||Standard Error|Least Squares Mean
687852|NCT01473758|Secondary|Change From Baseline in Blood Biomarker Fibrinogen (Extended Approach)|Biomarker Plasma fibrinogen was determined using the method described by Clauss. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.||umol/L||Standard Error|Least Squares Mean
687853|NCT01473758|Secondary|Change From Baseline in Blood Biomarker Fibrinogen (Initial Approach)|Biomarker Plasma fibrinogen was determined using the method described by Clauss. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.||umol/L||Standard Error|Least Squares Mean
687854|NCT01473758|Secondary|Change From Baseline in Blood Biomarker C-reactive Protein (CRP) (Extended Approach)|Blood was collected and serum biomarker CRP was measured using Roche Modular Analytics E 170 Module. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.||mg/L||Standard Error|Least Squares Mean
687855|NCT01473758|Secondary|Change From Baseline in Blood Biomarker C-reactive Protein (CRP) (Initial Approach)|Blood was collected and serum biomarker CRP was measured using Roche Modular Analytics E 170 Module. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.||mg/liter(L)||Standard Error|Least Squares Mean
687856|NCT01473758|Secondary|Change From Baseline in Blood Biomarker IL-1β (Extended Approach)|Blood was collected and serum biomarker IL-1β was quantified using commercial sandwich ELISA. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.||pg/mL||Standard Error|Least Squares Mean
687857|NCT01473758|Secondary|Change From Baseline in Blood Biomarker Interleukin-1 Beta (IL-1β) (Initial Approach)|Blood was collected and serum biomarker IL-1β was quantified using commercial sandwich ELISA. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.||pg/mL||Standard Error|Least Squares Mean
687949|NCT01473368|Primary|Gastrointestinal Symptoms Response Scale|Mean Gastrointestinal Symptom Rating Scale scores Range from 15 to 90 Increasing score means increasing symptoms|Day 21|Participants analyzed were those with complete data at Day 14||units on a scale||Standard Deviation|Mean
687858|NCT01473758|Secondary|Change From Baseline in Blood Biomarker Interleukin (IL)-6 (Extended Approach)|Blood was collected and serum biomarker IL-6 was quantified using commercial sandwich ELISA. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.||pg/mL||Standard Error|Least Squares Mean
687859|NCT01473758|Secondary|Change From Baseline in Blood Biomarker Interleukin (IL)-6 (Initial Approach)|Blood was collected and serum biomarker IL-6 was quantified using commercial sandwich ELISA. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.||pg/mL||Standard Error|Least Squares Mean
687860|NCT01473758|Secondary|Change From Baseline in Sputum Marker Concentration of Neutrophil Elastase (Extended Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Sputum inflammatory marker Neutrophil Elastase was quantified by commercial sandwich enzyme-linked immunosorbent assays (ELISA). A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.||µg/mL||Standard Error|Least Squares Mean
687861|NCT01473758|Secondary|Change From Baseline in Sputum Marker Concentration of Neutrophil Elastase (Initial Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Sputum inflammatory marker Neutrophil Elastase was quantified by commercial sandwich enzyme-linked immunosorbent assays (ELISA). A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.||µg/mL||Standard Error|Least Squares Mean
687862|NCT01473758|Secondary|Change From Baseline in Sputum Marker Concentration of Myeloperoxidase (MPO) (Extended Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Sputum inflammatory marker MPO was quantified by commercial sandwich enzyme-linked immunosorbent assays (ELISA). A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.||ng/mL||Standard Error|Least Squares Mean
687863|NCT01473758|Secondary|Change From Baseline in Sputum Marker Concentration of Myeloperoxidase (MPO) (Initial Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Sputum inflammatory marker MPO was quantified by commercial sandwich enzyme-linked immunosorbent assays (ELISA). A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.||ng/mL||Standard Error|Least Squares Mean
687864|NCT01473758|Secondary|Change From Baseline in Sputum Marker Concentration of Interleukin (IL)-8 (Extended Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Sputum inflammatory marker IL-8 was quantified by commercial sandwich enzyme-linked immunosorbent assays (ELISA). A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.||pg/mL||Standard Error|Least Squares Mean
687865|NCT01473758|Secondary|Change From Baseline in Sputum Marker Concentration of Interleukin (IL)-8 (Initial Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Sputum inflammatory marker IL-8 was quantified by commercial sandwich enzyme-linked immunosorbent assays (ELISA). A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.||pg/mL||Standard Error|Least Squares Mean
687866|NCT01473758|Secondary|Change From Baseline in Sputum Marker Concentration of Interleukin (IL)-6 (Extended Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Sputum inflammatory marker IL-6 was quantified by commercial sandwich enzyme-linked immunosorbent assays (ELISA). A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.||pg/mL||Standard Error|Least Squares Mean
708914|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 30||Month 30|||L||Standard Error|Mean
687867|NCT01473758|Secondary|Change From Baseline in Sputum Marker Concentration of Interleukin (IL)-6 (Initial Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Sputum inflammatory marker IL-6 was quantified by commercial sandwich enzyme-linked immunosorbent assays (ELISA). A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.||pg/mL||Standard Error|Least Squares Mean
687868|NCT01473758|Secondary|Change From Baseline in Sputum Marker Percentage of Lymphocytes (Extended Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Aliquots of a cell suspension prepared from the sputum sample were used to prepare cytospin slides that were stained with Diff-Quik for differential cell counts. 100 cells were counted and the percentage of lymphocytes was determined. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.||percentage of lymphocytes||Standard Error|Least Squares Mean
687869|NCT01473758|Secondary|Change From Baseline in Sputum Marker Percentage of Lymphocyte (Initial Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Aliquots of a cell suspension prepared from the sputum sample were used to prepare cytospin slides that were stained with Diff-Quik for differential cell counts. 100 cells were counted and the percentage of lymphocytes was determined. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.||percentage of lymphocytes||Standard Error|Least Squares Mean
687870|NCT01473758|Secondary|Change From Baseline in Sputum Marker Percentage of Eosinophils (Extended Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Aliquots of a cell suspension prepared from the sputum sample were used to prepare cytospin slides that were stained with Diff-Quik for differential cell counts. 100 cells were counted and the percentage of eosinophils was determined. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.||percentage of macrophages||Standard Error|Least Squares Mean
687871|NCT01473758|Secondary|Change From Baseline in Sputum Marker Percentage of Eosinophils (Initial Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Aliquots of a cell suspension prepared from the sputum sample were used to prepare cytospin slides that were stained with Diff-Quik for differential cell counts. 100 cells were counted and the percentage of eosinophils was determined. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.||percentage of eosinophils||Standard Error|Least Squares Mean
687872|NCT01473758|Secondary|Change From Baseline in Sputum Marker Percentage of Macrophages (Extended Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Aliquots of a cell suspension prepared from the sputum sample were used to prepare cytospin slides that were stained with Diff-Quik for differential cell counts. 100 cells were counted and the percentage of macrophages was determined. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.||percentage of macrophages||Standard Error|Least Squares Mean
687873|NCT01473758|Secondary|Change From Baseline in Sputum Marker Percentage of Macrophages (Initial Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Aliquots of a cell suspension prepared from the sputum sample were used to prepare cytospin slides that were stained with Diff-Quik for differential cell counts. 100 cells were counted and the percentage of macrophages was determined. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.||percentage of macrophages||Standard Error|Least Squares Mean
687893|NCT01473602|Secondary|Percentage of Participants With Functional Evidence of Healing|"Functional healing was defined as ability to walk with a gait speed ≥ 0.05 meters/second (m/s) with a change from baseline ≥ -0.1 m/s. The walking test involved having the participant walk a distance of 7 meters (m) at a self-selected, comfortable pace. A 4-m portion of the test was timed to determine the participant’s gait speed in m/s.
Percentage was calculated as: (number of participants with functional evidence of healing / total number of participants analyzed) * 100."|Up to 12 Months|Participants who were randomized, received at least 1 dose of study drug, and had either at least one nonmissing gait speed or non-ambulatory status. LOCF values used.||Percentage of participants|||Number
708915|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 24||Month 24|||L||Standard Error|Mean
687874|NCT01473758|Secondary|Change From Baseline in Sputum Marker Percentage of Neutrophils (Extended Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Aliquots of a cell suspension prepared from the sputum sample were used to prepare cytospin slides that were stained with Diff-Quik for differential cell counts. 100 cells were counted and the percentage of neutrophils was determined. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction. A negative change from Baseline indicates improvement.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.||percentage of neutrophils||Standard Error|Least Squares Mean
687875|NCT01473758|Secondary|Change From Baseline in Sputum Marker Percentage of Neutrophils (Initial Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Aliquots of a cell suspension prepared from the sputum sample were used to prepare cytospin slides that were stained with Diff-Quik for differential cell counts. 100 cells were counted and the percentage of neutrophils was determined. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.||percentage of neutrophils||Standard Error|Least Squares Mean
687876|NCT01473758|Secondary|Change From Baseline in Sputum Marker Total Cells (Extended Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Total cell count (absolute number of nonsquamous cells per gram of the original sputum sample) were determined using a Neubauer hemocytometer. A negative change from Baseline indicates improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.||10^6 cells/gram sputum||Standard Error|Least Squares Mean
687877|NCT01473758|Secondary|Change From Baseline in Sputum Marker Total Cells (Initial Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Total cell count (absolute number of nonsquamous cells per gram of the original sputum sample) were determined using a Neubauer hemocytometer. A negative change from Baseline indicates improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.||10^6 cells/gram sputum||Standard Error|Least Squares Mean
687878|NCT01473758|Secondary|Percentage of Participants Whose Sputum Neutrophil Counts Returned to Stable State at Day 14 (Extended Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Total cell count (absolute number of nonsquamous cells per gram of the original sputum sample) and were determined with a Neubauer hemocytometer.|Day 14|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.||percentage of participants||95% Confidence Interval|Number
687879|NCT01473758|Secondary|Percentage of Participants Whose Sputum Neutrophil Counts Returned to Stable State at Day 14 (Initial Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Total cell count (absolute number of nonsquamous cells per gram of the original sputum sample) and were determined with a Neubauer hemocytometer.|Day 14|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.||percentage of participants||95% Confidence Interval|Number
687880|NCT01473758|Primary|Change From Baseline in Sputum Neutrophil Counts at Day 14 Post Exacerbation (Extended Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Total cell count (absolute number of nonsquamous cells per gram of the original sputum sample) were determined using a Neubauer hemocytometer. A negative change from Baseline indicates improvement. An Analysis of Covariance (ANCOVA) model was used with neutrophil count at Baseline and treatment as independent variables, fixed effects.|Baseline and Day 14|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.||10^6 cells/gram sputum||Standard Error|Least Squares Mean
687881|NCT01473758|Primary|Change From Baseline in Sputum Neutrophil Counts at Day 14 Post Exacerbation (Initial Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Total cell count (absolute number of nonsquamous cells per gram of the original sputum sample) were determined using a Neubauer hemocytometer. A negative change from Baseline indicates improvement. An Analysis of Covariance (ANCOVA) model was used with neutrophil count at Baseline and treatment as independent variables, fixed effects.|Baseline and Day 14|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Analysis included all participants who received treatment in Cycle 1.||10^6 cells/gram sputum||Standard Error|Least Squares Mean
687882|NCT01473745|Secondary|1 Nasolabial Angular Parameters|2D nasolabial angular parameter: Nasolabial angle (NLA) (The NLA was a two dimensional measurement and was measured at the midsagittal plane with Image J software®)|up to post-operation 6 months|||degree||Standard Deviation|Mean
687883|NCT01473745|Secondary|14 Nasolabial Linear Parameters|"baseline characteristics: intercanthulus distance
nasal linear parameters
nasolabial linear parameters"|up to post-operation 6 months|||mm||Standard Deviation|Mean
687981|NCT01472835|Secondary|Pain Score|0-10 numerical rating scale (NRS) pain scale. 0 being no pain and 10 being the worst possible pain.|1-month|||units on a scale||Standard Deviation|Mean
687884|NCT01473745|Primary|Soft and Hard Tissue Landmarks Movement|"The investigator measured the movement (1 month minus baseline) of hard tissue landmarks before and after 4-6 weeks maxillary LeFort I osteotomy. The movement (6 months minus baseline) of soft tissue landmarks was measured before and after 6 months of the maxillary LeFort I osteotomy.
The 3D directional movement of each point was measured in the x(transverse), y(vertical), and z (antero-posterior)planes. The positive directional movement of each point in X axis means the point moved left after surgery, and negative directional movement in X axis means the the point moved right after surgery. The positive directional movement in Y axis means the point moved upward after surgery, and negative directional movement in Y axis means the the point moved downward after surgery. The positive directional movement in Z axis means the point moved anteriorly after surgery, and negative directional movement in Z axis means the the point moved posteriorly after surgery."|The hard tissue movements were assessed after surgery 4-6 weeks.The soft tissue movements were assessed after surgery 6 months.|similar sex distribution in both groups (7 male and 17 female patients in Group C, and 8 male and 16 female patients in Group M)||mm||Standard Deviation|Mean
687885|NCT01473602|Secondary|Mean Change From Baseline to 6 Months on European Quality of Life Questionnaire (EQ-5D) Overall Health Score|The EQ-5D is a 5-item, self-reported, generic, multidimensional, health-related, quality-of-life instrument with 5 items. Overall health state score was also self-reported using a visual analogue scale (VAS) marked on a scale scored from 0 (worst imaginable health state) to 100 (best imaginable health state). Higher scores represented better health state with 0 representing worst imaginable health state and 100 representing best imaginable health state. LS means was calculated using ANCOVA adjusted for baseline, treatment group, region.|Baseline, 6 Months|Participants who were randomized, received treatment, were adjudicated as having the hip fracture in the neck of the femur and had baseline and at least 1 nonmissing post-baseline measurement.||Units on a scale||Standard Error|Least Squares Mean
687886|NCT01473602|Secondary|Mean Change From Baseline to 6 Months on Western Ontario McMaster Osteoarthritis Index (WOMAC)|WOMAC: was a self-reported questionnaire that consisted of 24 questions covering 3 health domains: Pain (5 items: during walking, using stairs, in bed, sitting or lying, and standing), Stiffness (2 items: after first waking and later in the day), and Physical Function. Each domain was scored by summing the individual items and transforming the scores into a 0 to 100 (best to worst) scale. Lower scores indicated better health status or functioning. LS means was calculated using ANCOVA adjusted for baseline, treatment group, region, fracture type, fixation type, visit, and visit-by-treatment interaction.|Baseline, up to 6 Months|Participants who were randomized, received treatment, were adjudicated as having the hip fracture in the neck of the femur and had baseline and at least 1 nonmissing post-baseline measurement..||Units on a scale||Standard Error|Least Squares Mean
687887|NCT01473602|Secondary|Mean Change From Baseline to 6 Months on Short Form-12 (SF-12) Physical (PCS) and Mental Component Summary (MCS) Scores|SF-12 is a self-reported questionnaire covering a mental component score (MCS) and a physical component score (PCS), each scoring from a 0 to 100 (worst to best) scale. LS means was calculated using ANCOVA adjusted for baseline, treatment group, region, fracture type, fixation type, visit, and visit-by-treatment interaction.|Baseline, 6 Months|Participants who were randomized, received treatment, were adjudicated as having the hip fracture in the neck of the femur and had baseline and at least 1 nonmissing post-baseline measurement..||Units on a scale||Standard Error|Least Squares Mean
687888|NCT01473602|Secondary|Time to Revision Surgery|Time to revision surgery was defined as the time from initial hip fracture surgery to revision surgery, or recommendation for revision surgery if recommended but not performed. Time to revision surgery was censored at the date of the last contact.|Baseline to Revision Surgery (up to 14.14 Months)|Participants who were randomized, received at least 1 dose of study drug, and who did not have revision surgery or if they had revision surgery, it was adjudicated as not being related to the initial hip fracture surgery. Participants censored: Teriparatide = 14; placebo = 19.||Days||Full Range|Median
687889|NCT01473602|Secondary|Mean Change From Baseline to 6 Months in Gait Speed|The walking test involved having the participant walk a distance of 7 m at a self-selected, comfortable pace. A 4-m portion of the test was timed to determine the participant’s gait speed in m/s. LS means was calculated using ANCOVA adjusted for baseline, treatment group, region, fracture type, and fixation type|Baseline, 6 Months|Participants who were randomized, received at least 1 dose of study drug, had baseline and at least 1 nonmissing post-baseline measurement.||m/s||Standard Error|Least Squares Mean
687890|NCT01473602|Secondary|Mean Change From Baseline to 6 Months in Worst Fracture-Site Pain|The worst pain NRS was used to assess the impact of pain on a participant's life. Participants with an NRS score of <7 were categorized as having no severe fracture-site pain. Least squares (LS) means was calculated using analysis of covariance (ANCOVA) adjusted for baseline, treatment group, region, fracture type, and fixation type.|Baseline, 6 Months|Participants who were randomized, received at least 1 dose of study drug, had baseline and at least 1 nonmissing post-baseline measurement..||Units on a scale||Standard Error|Least Squares Mean
687891|NCT01473602|Secondary|Percentage of Participants Who Regained Their Prefracture Ambulatory Status|Prefracture ambulatory status was defined as either ambulatory with or without a walking aid. A participant was considered to have regained their prefracture ambulatory status if the participant's postsurgery ambulatory status was returned to or was improved from their pre-surgery ambulatory status. Percentage was calculated as = (number of participants who regained their ambulatory status / total number of participants analyzed) *100.|Up to 12 months|Participants who were randomized, received at least 1 dose of study drug, and had baseline and at least one nonmissing post-baseline measurement. LOCF values used.||Percentage of participants|||Number
687892|NCT01473602|Secondary|Percentage of Participants Able to Ambulate|Ability to ambulate was defined as ambulatory with or without convalescent aid. Percentage was calculated as: (number of participants able to ambulate / total number of participants analyzed) * 100.|Up to 12 months|Participants who were randomized, received treatment and had at least 1 nonmissing post-baseline measurement. LOCF values used||Percentage of participants|||Number
687903|NCT01473589|Secondary|Mean Change From Baseline to 6 Months in Gait Speed|The walking test involved having the participant walk a distance of 7 m at a self-selected, comfortable pace. A 4-m portion of the test was timed to determine the participant's gait speed in m/s. LS means was calculated using ANCOVA and adjusted for baseline, treatment group, region, fracture type, and fixation type.|Baseline, up to 6 Months|Participants who were randomized, received at least 1 dose of study drug and had baseline and at least one nonmissing post-baseline measurement.||m/s||Standard Error|Least Squares Mean
687894|NCT01473602|Secondary|Percentage of Participants Without Severe Fracture-Site Pain During Weight Bearing|The worst pain NRS was used to assess the impact of pain on a participant's life. Fracture-site pain severity was assessed for pain on weight bearing. Pain was measured by an 11-point Likert scale. Participants with an NRS score of <7 during weight bearing and no worsening of NRS score >2 from baseline were categorized as having no severe fracture-site pain. Percentage was calculated as: (number of participants with pain control during weight bearing / total number of participants) * 100.|Up to 12 months|Participants who were randomized, received at least 1 dose of study drug and had baseline and at least one nonmissing post-baseline measurement. LOCF values used.||Percentage of participants|||Number
687895|NCT01473602|Secondary|Percentage of Participants Without Severe Fracture-Site Pain During 24 Hours Prior to Visit|The NRS was used to assess the impact of pain on a participant's life. Fracture-site pain severity was assessed for pain in the 24 hours preceding a visit. Pain was measured by an 11-point Likert scale. Participants with an NRS score of <7 in the 24 hours preceding a visit and no worsening of NRS score >2 from baseline were categorized as having no severe fracture-site pain. Percentage was calculated as: (number of participants with pain control during 24 hours preceding a visit / total number of participants analyzed) * 100.|Up to 12 months|Participants who were randomized, received at least 1 dose of study drug and had baseline and at least one nonmissing post-baseline measurement for severe fracture-site pain in the last 24 hours.. LOCF values used.||Percentage of participants|||Number
687896|NCT01473602|Secondary|Percentage of Participants With Pain Control During Ambulation|The worst pain numeric rating scale (NRS) was used to assess the impact of pain on a participant's life. NRS Item 3 assessed the worst musculoskeletal pain severity during the walking test. Pain was measured by an 11-point Likert scale. The following cut-points were used to categorize the NRS responses: 0 = no pain, 1 to 4 = mild pain, 5 to 6 = moderate pain, and 7 to 10 = severe pain. Higher scores indicated more severe pain. Participants with an NRS score of <7 and no worsening of NRS scores >2 from baseline were categorized as having no severe fracture-site pain. Percentage was calculated as: (number of participants with pain control during ambulation / total number of participants analyzed) * 100.|Up to 12 months|Participants who were randomized, received at least 1 dose of study drug, had baseline and at least 1 nonmissing post-baseline measurement. Last observation carried forward (LOCF) values used.||Percentage of participants|||Number
687897|NCT01473602|Secondary|Percentage of Participants With Radiographic Evidence of Healing|"The signs of femoral neck fracture healing and healing complications included disappearance of the fracture line on radiographs. If a participant had radiographic evidence of healing at the 12-month visit, that participant was considered to have radiographic evidence of healing.
Percentage was calculated as: (number of participants with radiographic evidence of healing / total number of participants analyzed) * 100."|Randomization up to 12 months|Participants who were randomized and received at least 1 dose of study drug.||Percentage of participants|||Number
687898|NCT01473602|Primary|Percentage of Participants With No Revision Surgery at 12 Months After Internal Fixation of a Low-Trauma Femoral Neck Fracture|Revision surgery (re-operation) was defined as any additional surgical intervention performed or recommended at the site of the index procedure, except those that were planned at the time of the index procedure.|12 months|Participants who were randomized, received at least 1 dose of study drug.||Percentage of participants||90% Confidence Interval|Number
687899|NCT01473589|Secondary|Mean Change From Baseline to 6 Months on European Quality of Life Questionnaire (EQ-5D) Health State Score|The EQ-5D is a 5-item, self-reported, generic, multidimensional, health-related, quality-of-life instrument with 5 items. Overall health state score was also self-reported using a visual analogue scale (VAS) marked on a scale scored from 0 (worse imaginable health state) to 100 (best imaginable health state). LS mean was calculated using ANCOVA and adjusted for baseline, treatment group, and region.|Baseline, up to 6 Months|All randomized participants who were randomized, received at least 1 dose of study drug, were adjudicated as having the hip fracture in the neck of the femur, and had baseline and at least 1 nonmissing post-baseline measurement.||units on a scale||Standard Error|Least Squares Mean
687900|NCT01473589|Secondary|Mean Change From Baseline to 6 Months on Western Ontario McMaster Osteoarthritis Index (WOMAC)|WOMAC is: a self-reported questionnaire that consisted of 24 questions covering 3 health domains: Pain (5 items: during walking, using stairs, in bed, sitting or lying, and standing), Stiffness (2 items: after first waking and later in the day), and Physical Function. Each domain was scored by summing the individual items and transforming the scores into a 0 to 100 (best to worst) scale. LS mean was calculated using ANCOVA and adjusted for baseline, treatment group, region, fracture type, fixation type, visit, and visit-by-treatment interaction.|Baseline, up to 6 Months|Participants who were randomized, received at least 1 dose of study drug, were adjudicated as having the hip fracture in the neck of the femur and had baseline and at least 1 nonmissing post-baseline measurement.||units on a scale||Standard Error|Least Squares Mean
687901|NCT01473589|Secondary|Mean Change From Baseline to 6 Months on Short Form-12 (SF-12) Physical (PCS) and Mental Component Summary (MCS) Scores|SF-12 is a self-reported questionnaire covering a mental component score (MCS) and a physical component score (PCS), each scoring from a 0 to 100 (worst to best) scale. LS mean was calculated using ANCOVA and adjusted for baseline, treatment group, region, fracture type, fixation type, visit, and visit-by-treatment interaction.|Baseline, up to 6 Months|Participants who were randomized, received at least 1 dose of study drug, were adjudicated as having the hip fracture in the neck of the femur and had baseline and at least 1 nonmissing post-baseline measurement.||units on a scale||Standard Error|Least Squares Mean
687902|NCT01473589|Secondary|Time to Revision Surgery|Time to revision surgery was defined as the time from initial hip fracture surgery to revision surgery, or recommendation for revision surgery if recommended but not performed. Time to revision surgery was censored at the date of the last contact.|Baseline to revision surgery (up to 14.14 Months)|Participants who were randomized, received at least 1 dose of study drug, and who did not have revision surgery or if they had revision surgery, it was adjudicated as not being related to the initial hip fracture surgery. Participants censored: Teriparatide = 51; placebo = 51.||days||Full Range|Median
687950|NCT01473368|Primary|Gastrointestinal Symptoms Response Score|Mean Gastrointestinal Symptom Rating Scale scores Range from 15 to 90 Increasing score means increasing symptoms|Day 14|Participants analyzed were those with complete data at Day 14||units on a scale||Standard Deviation|Mean
687951|NCT01473368|Primary|Gastrointestinal Symptom Rating Scale|Mean Gastrointestinal Symptom Rating Scale scores Range from 15 to 90 Increasing score means increasing symptoms|Day 7|||Units on a scale||Standard Deviation|Mean
687905|NCT01473589|Secondary|Percentage of Participants Who Regain Their Prefracture Ambulatory Status|Prefracture ambulatory status was defined as either ambulatory with or without a walking aid. A participant was considered to have regained their prefracture ambulatory status if the participant's postsurgery ambulatory status was returned to or was improved from their pre-surgery ambulatory status. Percentage was calculated as = (number of participants who regained their ambulatory status / total number analyzed) * 100.|Up to 12 months|Participants who were randomized, received at least 1 dose of study drug, and had baseline and at least one nonmissing post-baseline measurement. LOCF values used.||percentage of participants|||Number
687906|NCT01473589|Secondary|Percentage of Participants Able to Ambulate|Ability to ambulate was defined as ambulatory with convalescent aid or without convalescent aid. Percentage was calculated as: (number of participants able to ambulate / number of total participants analyzed) * 100.|Up to 12 months|Participants who were randomized and received at least 1 dose of study drug and had at least 1 nonmissing post-baseline measurement. LOCF values used.||percentage of participants|||Number
687907|NCT01473589|Secondary|Percentage of Participants With Functional Evidence of Healing|"Functional healing was defined as ability to walk with a gait speed ≥ 0.05 meters/second (m/s) with a change from baseline ≥ -0.1 m/s. The walking test involved having the participant walk a distance of 7 meters (m) at a self-selected, comfortable pace. A 4-m portion of the test was timed to determine the participant's gait speed in m/s.
Percentage was calculated as: (number of participants with functional evidence of healing / total number of participants analyzed) * 100."|12 Months|Participants who were randomized, received at least 1 dose of study drug, and had either at least one nonmissing gait speed or non-ambulatory status. LOCF values used.||percentage of participants|||Number
687908|NCT01473589|Secondary|Percentage of Participants Without Severe Fracture-Site Pain During Weight Bearing|The worst pain NRS was used to assess the impact of pain on a participant's life. Fracture-site pain severity was assessed for pain on weight bearing. Pain was measured by an 11-point Likert scale. Participants with an NRS score of <7 during weight bearing and no worsening of NRS >2 from baseline were categorized as having no severe fracture-site pain. Percentage was calculated as: (number of participants with pain control during weight bearing / total number of participants) * 100.|Up to 12 months|Participants who were randomized, received at least 1 dose of study drug and had baseline and at least 1 nonmissing post-baseline measurement. LOCF values used.||percentage of participants|||Number
687909|NCT01473589|Secondary|Percentage of Participants Without Severe Fracture-Site Pain During 24 Hours Prior to Visit|The worst pain NRS was used to assess the impact of pain on a participant's life. Fracture-site pain severity was assessed for pain in the 24 hours preceding a visit. Pain was measured by an 11-point Likert scale. Participants with an NRS score of <7 in the 24 hours preceding a visit and no worsening of NRS >2 from baseline were categorized as having no severe fracture-site pain. Percentage was calculated as: (number of participants with pain control during 24 hours preceding a visit / total number of participants) * 100.|Up to 12 months|Participants who were randomized, received at least 1 dose of study drug and had baseline and at least one nonmissing post-baseline measurement for severe fracture-site pain in the last 24 hours. LOCF values used.||percentage of participants|||Number
687910|NCT01473589|Secondary|Percentage of Participants With Pain Control During Ambulation|The worst pain numeric rating scale (NRS) was used to assess the impact of pain on a participant's life. NRS Item 3 assessed the worst musculoskeletal pain severity during the walking test. Pain was measured by an 11-point Likert scale. The following cut-points were used to categorize the NRS responses: 0 = no pain, 1 to 4 = mild pain, 5 to 6 = moderate pain, and 7 to 10 = severe pain. Participants with an NRS score of <7 were categorized as having no severe fracture-site pain with ambulation and no worsening of NRS scores >2 from baseline. Percentage was calculated as: (Number of participants with pain control during ambulation / total number of participants) * 100.|Up to 12 months|Participants who were randomized, received treatment, and had baseline and at least one nonmissing post-baseline measurement. Last observation carried forward (LOCF) values used.||percentage of participants|||Number
687911|NCT01473589|Secondary|Percentage of Participants With Radiographic Evidence of Healing|"The signs of femoral neck fracture healing included disappearance of the fracture line on radiographs. If a participant had radiographic evidence of healing at the 12-month visit, that participant was considered to have radiographic evidence of healing.
Percentage was calculated as: (number of participants with radiographic evidence of healing / total number of participants analyzed) * 100."|Randomization up to 12 months|Participants who were randomized and received at least 1 dose of study drug.||percentage of participants|||Number
687912|NCT01473589|Primary|Percentage of Participants With No Revision Surgery at 12 Months After Internal Fixation of a Low-Trauma Femoral Neck Fracture|Revision surgery (re-operation) was defined as any additional surgical intervention performed or recommended at the site of the index procedure, except those that were planned at the time of the index procedure.|12 months|Participants who were randomized and received at least 1 dose of study drug.||percentage of participants||90% Confidence Interval|Number
687913|NCT01473563|Secondary|Time to Treatment Failure (TTF)|The time from the date of the first dose of study treatment (Cycle 1, Day 1) to the date of death from any cause, PD (clinical and objective), or discontinuation of pemetrexed due to toxicity. Response was defined using RECIST, v1.1 criteria. PD was defined as having at least a 20% increase in the sum of the longest diameter of target lesions and at a minimum 5 mm increase above nadir. TTF was censored at the date of the last visit for participants who did not discontinue pemetrexed, who were still alive, and who had not progressed.|Cycle 1, Day 1 to first event (up to Cycle 19, 21 days/cycle)|ITT population: Participants who received at least 1 dose of study drug. Two (2) participants were censored.||months||95% Confidence Interval|Median
687914|NCT01473563|Secondary|Overall Survival (OS) at 6 Months|The percentage of participants who were alive at Month 6 was calculated as a cumulative percentage by Kaplan-Meier survival analyses approach. For participants not known to have died as of the cut-off date, OS was censored as the last contact date (known alive).|Cycle 1, Day 1 to the date of death from any cause (up to Month 6)|ITT population: Participants who received at least 1 dose of study drug. Twenty-four (24) participants were censored (alive) at the end of the study.||percentage of participants||95% Confidence Interval|Number
687952|NCT01473368|Primary|Gastrointestinal Symptom Rating Scale|Mean Gastrointestinal Symptom Rating Scale scores Range from 15 to 90 Increasing score means increasing symptoms|Day 0|Control participants were not assessed at this time point.||units on a scale||Standard Deviation|Mean
710426|NCT00161382|Secondary|Perceived Norms||Measured throughout the study||||||
687915|NCT01473563|Secondary|Resource Utilization: Distances Traveled|The distance traveled is reported by region (Great Britain and Sweden) and includes the distance traveled by the participant from his/her home to the hospital (Cycle 1) and other cycles where the homecare nurse traveled from the hospital to the participant's home. Due to the limited number of participants with evaluable data, results are reported for Cycles 1 through 4.|Cycle 1, Day 1 through last day of cycle when participant reverted to hospital administration or discontinued (up to Cycle 4, 21 days/cycle)|Participants who received at least 1 dose of study drug and had data for distance traveled for at least 1 cycle from Cycle 1 through Cycle 4.||kilometers (km)||Standard Deviation|Mean
687916|NCT01473563|Secondary|Resource Utilization: Duration of Health Care Visits|The duration of the health care visit in the home setting is reported. The visit started when the nurse arrived and included the entire treatment process. The visit ended when the nurse left the home setting. Due to the limited number of participants with evaluable data, results are reported for Cycles 2 through 4.|Cycle 2, Day 1 through last day of cycle when participant reverted to hospital administration or discontinued (up to Cycle 4, 21 days/cycle)|Participants who received at least 1 dose of study drug and had at least 1 health care visit in the home setting from Cycle 2 through Cycle 4.||hours||Standard Deviation|Mean
687917|NCT01473563|Other Pre-specified|Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), or Died|The number of participants who had at least 1 TEAE or serious TEAE (regardless of causality) is reported along with the number of participants who died (due to any cause) while on therapy or during treatment discontinuation follow-up (up to 6 months). TEAEs started on or after the date and time of first dose of study drug, or started prior to study drug but worsened after study drug started. Clinically significant events were defined as SAEs and other non-serious adverse events (AEs). A summary of SAEs and other non-serious AEs is located in the Reported Adverse Events module.|First dose of study drug (Cycle 1, Day 1) through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]|Safety Population: Participants who received at least 1 dose of study drug.||participants|||Number
687918|NCT01473563|Secondary|Resource Utilization: Unplanned Health Care Visits, Consultations, and Diagnostic Services|The unplanned use of any 1 of the following 4 resources is reported, as well as the unplanned use of each resource: accident and emergency dept., specialists (oncologist, pulmonologist etc.), GP or family doctor, and diagnostic procedures. Results are reported as the number of participants with an unplanned resource use (visit) for a specified number of times.|Cycle 1, Day 1 through last day of cycle when participant reverted to hospital administration or discontinued (up to Cycle 19, 21 days/cycle)|Participants who received at least 1 dose of study drug and had at least 1 unplanned use of health care resources.||participants|||Number
687919|NCT01473563|Secondary|Resource Utilization: Number of Participants With an Unplanned Use of Healthcare Resources|The number of participants who had at least 1 unplanned use of health care resources [accident and emergency department (dept.), specialists [oncologist, pulmonologist, etcetera (etc.)], general practitioner (GP) or family doctor, or diagnostic procedures] during the study is reported.|Cycle 1, Day 1 through last day of cycle when participant reverted to hospital administration or discontinued (up to Cycle 19, 21 days/cycle)|ITT population: Participants who received at least 1 dose of study drug.||participants|||Number
687920|NCT01473563|Secondary|Physician Satisfaction: Distant Management of Participant|"The physician was asked, How would you rate your overall satisfaction with the distant management of the participant during chemotherapy at home? Choices included: Very dissatisfied, Somewhat dissatisfied, Neither satisfied nor dissatisfied, Somewhat satisfied, or Very satisfied."|30 days post treatment discontinuation|Participants who received at least 1 dose of study drug and for whom the investigator answered the specified question at 30 days post treatment discontinuation.||investigators|||Number
687921|NCT01473563|Secondary|Participant Satisfaction: Preferences Regarding Home and/or Hospital Treatment|"Participants were asked to evaluate their preferences regarding home and/or hospital treatment delivery in this study by answering 2 questions (Q). Q15: Do you prefer having your chemotherapy at home or at the hospital, or are you indifferent? Choices included: Home, Hospital, or Indifferent. Q16: Would you recommend having chemotherapy at home to someone else in your same situation? Choices included: Yes, No, or Not sure."|The first evaluation completed at either Cycle 4, Day 1 (21 days/cycle) or 30 days post treatment discontinuation|Participants who received at least 1 dose of study drug and answered at least 1 of the specified questions.||participants|||Number
687922|NCT01473563|Secondary|Participant Satisfaction: Regarding the Study Nurse|"Participants were asked 7 questions (Q) about their study nurse for home treatment. Q8: Was the nurse an easy person to talk to?, Q9: When the nurse came, did you feel he/she had enough time to do the required things?, Q10: Do you think the nurse had time to discuss things with you?, Q11: Did you feel that the nurse knew enough about you and your illness? Choices for Q8 through Q11 included: Yes or No. Q12: Were you able to get all the information you wanted about your illness or treatment? Choices included: Yes, No, or Uncertain. Q13: Would you say that the nurse gave… Choices included: a lot of reassurance and support, some reassurance and support, or hardly any reassurance and support. Q14: How would you rate your overall satisfaction with the nursing staff during chemotherapy at home? Choices included: Very dissatisfied, Somewhat dissatisfied, Neither satisfied nor dissatisfied, Somewhat satisfied, or Very satisfied."|The first evaluation completed at either Cycle 4, Day 1 (21 days/cycle) or 30 days post treatment discontinuation|Participants who received at least 1 dose of study drug and answered at least 1 of the specified questions.||participants|||Number
687923|NCT01473563|Secondary|Participant Satisfaction: Chemotherapy at Home|"Participants were asked to evaluate their home treatment experiences in this study by answering 4 questions (Q). Q5: What do you do consider advantages of having chemotherapy at home? Choose all that apply. Choices included: No need to travel, Not having to wait for treatment, Personalized service, More privacy, and Other. Q6:What do you consider disadvantages of having chemotherapy at home? Choose all that apply. Choices included: Lack of other patients’ support, Extra burden for family/friends, Safety concerns, Need to rely on 1 medical specialist, and Other. Q7: How would you rate your overall satisfaction with chemotherapy at home? Choices included: Very dissatisfied, Somewhat dissatisfied, Neither satisfied nor dissatisfied, Somewhat satisfied, or Very satisfied."|The first evaluation completed at either Cycle 4, Day 1 (21 days/cycle) or 30 days post treatment discontinuation|Participants who received at least 1 dose of study drug and answered at least 1 of the specified questions.||participants|||Number
687924|NCT01473563|Secondary|Participant Satisfaction: Chemotherapy at Hospital|"Participants were asked to evaluate their hospital experiences in this study by answering 4 questions (Q). Q1: What do you consider advantages of having chemotherapy at the hospital? Choose all that apply. Choices included: Support from other patients, Access to other medical specialists, Access to more technical services, Safer in case something goes wrong, and Other. Q2: What do you consider disadvantages of having chemotherapy at the hospital? Choose all that apply. Choices included: Need to travel, Having to wait for treatment, Not having a personalized treatment, Lack of privacy on the ward, and Other. Q3: How would you rate your overall satisfaction with chemotherapy at the hospital? and Q4: How would you rate your overall satisfaction with the nursing staff during chemotherapy at the hospital? Choices for Q3 and Q4 included: Very dissatisfied, Somewhat dissatisfied, Neither satisfied nor dissatisfied, Somewhat satisfied, or Very satisfied."|The first evaluation completed at either Cycle 4, Day 1 (21 days/cycle) or 30 days post treatment discontinuation|Participants who received at least 1 dose of study drug and answered at least 1 of the specified questions.||participants|||Number
687925|NCT01473563|Secondary|Maximum Improvement Over Baseline in Individual Lung Cancer Symptoms Scale (LCSS) Item Scores|LCSS is a 9-item questionnaire; 6 items are symptom-specific measures for lung cancer (loss of appetite, fatigue, cough, dyspnea, hemoptysis, and pain), and 3 summation items describe overall symptomatic distress, interference with activity level, and overall quality of life during the past 24 hours. Participant responses were measured using a VAS with 100-millimeter (mm) lines. Scores ranged from 0 mm (no symptoms and no impact on activities, quality of life) to 100 mm (symptoms as bad as they could be, impacting activities and quality of life).|Baseline, Day 1 of each cycle (up to Cycle 19, 21 days/cycle), and 30 days post treatment discontinuation|Participants who received at least 1 dose of study drug and had a baseline and at least 1 post-baseline LCSS assessment.||mm||Standard Deviation|Mean
687926|NCT01473563|Secondary|Change From Baseline in the EQ-5D Index Score|The EQ-5D scale was used to provide an estimate of the health state utility in this population. The EQ-5D scale includes a 5-dimensional descriptive system that measures each of the health state attributes: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression according to a 3-point scale (no problem, some problems, and major problems) and a VAS that allows participants to rate their present health condition from 0 (worst imaginable health state) to 100 (best imaginable health state). The change from baseline EQ-5D Index score is reported and the EQ-5D Index score was calculated by converting health state scores into a weighted health state index according to a United Kingdom population-based algorithm. The possible values for the EQ-5D Index score range from −0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension), on a scale where 1 represents the best possible health state.|Baseline, Day 1 of Cycles 2 and 4 (21 days/cycle) and 30 days post treatment discontinuation|Participants who received at least 1 dose of study drug and had a baseline and at least 1 post-baseline EQ-5D index assessment.||units on a scale||Standard Deviation|Mean
687927|NCT01473563|Secondary|Change From Baseline in the European Quality of Life Instrument (EQ-5D) Visual Analogue Scale (VAS)|The EQ-5D scale was used to provide an estimate of the health state utility in this population. The EQ-5D scale includes a 5-dimensional descriptive system that measures each of the health state attributes: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression according to a 3-point scale (no problem, some problems, and major problems) and a VAS that allows participants to rate their present health condition from 0 (worst imaginable health state) to 100 (best imaginable health state). The change from baseline in EQ-5D VAS is reported.|Baseline, Day 1 of Cycles 2 and 4 (21 days/cycle) and 30 days post treatment discontinuation|Participants who received at least 1 dose of study drug and had a baseline and at least 1 post-baseline EQ-5D VAS assessment.||units on a scale||Standard Deviation|Mean
687928|NCT01473563|Primary|Percentage of Participants Who Adhered to Treatment Administration at Home|Participants were considered adherent from the time of the first dose in Cycle 1 (hospital administration) until either the last day of the cycle when the participant reverted to pemetrexed hospital administration or the last day of the cycle when the participant discontinued study treatment or the study for reasons related to the home setting. The percentage of participants who adhered to treatment administration at home was estimated by a Kaplan-Meier survival analyses approach. Participants who died or discontinued the study and treatment without reverting to hospital administration were censored at the time of discontinuation.|Cycle 1, Day 1 through Cycle 19, Day 1 and Cycle 19, Day 1 (21 days/cycle)|Intention-to-Treat (ITT) population: Participants who received at least 1 dose of study drug. The number of participants censored was 6, 9, 7, 8, 7, 1, 0, 2, 2, 2, 2, 0, 3, 0, 0, 0, 0, 0, and 1 for Cycles 1 through 19, respectively.||percentage of participants||95% Confidence Interval|Number
687929|NCT01473524|Secondary|Gamma-glutamyltransferase (GGT) Absolute Change From Baseline to Month 12|Gamma-glutamyltransferase (GGT) Absolute Change from Baseline to Month 12|12 months|Intent-to-Treat Population||U/L||Standard Error|Least Squares Mean
687930|NCT01473524|Secondary|Aspartate Aminotransferase (AST) Absolute Change From Baseline to Month 12|Aspartate Aminotransferase (AST) Absolute Change from Baseline to Month 12|12 months|Intent-to-Treat Population||U/L||Standard Error|Least Squares Mean
687931|NCT01473524|Secondary|Alanine Aminotransferase (ALT) Absolute Change From Baseline to Month 12|Alanine Aminotransferase (ALT) Absolute Change from Baseline to Month 12|12 months|Intent-to-Treat Population||U/L||Standard Error|Least Squares Mean
687932|NCT01473524|Secondary|Direct Bilirubin Absolute Change From Baseline to Month 12|Direct Bilirubin Absolute Change from Baseline to Month 12|12 months|Intent-to-Treat Population||umol/L||Standard Error|Least Squares Mean
687933|NCT01473524|Secondary|Total Bilirubin Absolute Change From Baseline to Month 12|Total Bilirubin Absolute Change from Baseline to Month 12|12 months|Intent-to-Treat Population||umol/L||Standard Error|Least Squares Mean
687934|NCT01473524|Secondary|Alkaline Phosphatase Absolute Change From Baseline to Month 12|Alkaline Phosphatase Absolute Change from Baseline to Month 12|12 months|Intent-to-Treat Population||U/L||Standard Error|Least Squares Mean
687935|NCT01473524|Secondary|Composite Endpoint Alkaline Phosphatase and Total Bilirubin, 5-10 mg vs. Placebo|Proportion of subjects at Month 6 with ALP < 1.67x ULN and total bilirubin ≤ ULN and ALP decrease of ≥ 15% from baseline.|6 Months|Intent-to-Treat Population||percentage of participants|||Number
687936|NCT01473524|Secondary|Composite Endpoint Alkaline Phosphatase and Total Bilirubin, 5-10 mg vs. Placebo|Proportion of subjects at Month 12 with ALP < 1.67x ULN and total bilirubin ≤ ULN and ALP decrease of ≥ 15% from baseline.|12 Months|Intent-to-Treat Population||percentage of participants|||Number
687939|NCT01473394|Secondary|Percentage of Participants With a Montgomery-Åsberg Depression Rating Scale (MADRS) Sustained Response Rate|The MADRS Sustained response rate is defined as a MÅDRS total score ≤ 12 for at least the last 2 consecutive visits during the double-blind treatment period.|Baseline to Week 8|Intent-to-treat population: All randomized participants who received at least 1 dose of double-blind investigational product and who had a Baseline and at least 1 post-baseline assessment of the MADRS total score.||Percentage of participants||95% Confidence Interval|Number
687940|NCT01473394|Secondary|Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Score at Week 8|The CGI-S is a clinician-rated scale for assessing the severity of the participant’s current state of mental illness compared with a patient population with major depressive disorder. The clinician responded to the following question “Considering your total clinical experience with this population, how mentally ill is the participant at this time?” on a 7-point scale: 1=normal, not at all ill; 2=borderline ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. The scale ranges from 1 to 7. A higher score indicates more severe mental illness. A negative change score indicates improvement.|Baseline to Week 8|Intent-to-treat population: All randomized participants who received at least 1 dose of double-blind investigational product and who had a Baseline and at least 1 post-baseline assessment of the MADRS total score.||Units on a scale||Standard Error|Least Squares Mean
687941|NCT01473394|Primary|Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 8|The MADRS is a clinician-rated scale for assessing depressive symptomatology that had occurred in participants during the week preceding each interview. Patients were rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest. Each item was scored on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score was the sum of the scores on the 10 items and ranged from 0 to 60. A higher score indicated more depressive symptomatology. A negative change score indicated improvement.|Baseline to Week 8|Intent-to-treat population: All randomized participants who received at least 1 dose of double-blind investigational product and who had a Baseline and at least 1 post-baseline assessment of the MADRS total score.||Units on a scale||Standard Error|Least Squares Mean
687942|NCT01473381|Secondary|Percentage of Participants With a Montgomery-Åsberg Depression Rating Scale (MADRS) Sustained Response|The MADRS is a clinician-rated scale based on participant interviews. The scale assesses depressive symptomatology that occurred in participants during the week preceding each interview. Participants were rated on 10 items: Apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item was scored on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score was the sum of the scores of the 10 items and ranged from 0 to 60. A higher score indicates more depressive symptomatology. A MADRS sustained response was defined as a MADRS total score ≤ 12 for at least the last 2 visits during the double-blind treatment period (Weeks 1-10). A total MADRS score ≤ 12 corresponds to an average score of 1 per item and is indicative of very low level of depressive symptoms.|Baseline to Week 10|Intent-to-treat population: All randomized participants who received at least 1 dose of placebo, vilazodone, or citalopram and who had a baseline and at least 1 post-baseline assessment of the MADRS total score.||Percentage of participants||95% Confidence Interval|Number
687943|NCT01473381|Secondary|Change From Baseline to Week 10 in the Clinical Global Impressions-Severity (CGI-S) Scale Score|The Clinical Global Impressions-Severity scale is a clinician-rated scale used to rate the severity of the participant’s current state of mental illness compared with a patient population with major depressive disorder. In particular, the clinician is asked to respond to the following question: “Considering your total clinical experience with this population, how mentally ill is the patient at this time?” The patient is rated on the following 7-point scale: 1-normal, not at all ill, 2-borderline ill, 3-mildly ill, 4-moderately ill, 5-markedly ill, 6-severely ill, 7-among the most extremely ill patients. A higher score indicates more mental illness. A negative change score indicates improvement.|Baseline to Week 10|Intent-to-treat population: All randomized participants who received at least 1 dose of placebo, vilazodone, or citalopram and who had a baseline and at least 1 post-baseline assessment of the MADRS total score.||Units on a scale||Standard Error|Least Squares Mean
687944|NCT01473381|Primary|Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 10|The MADRS is a clinician-rated scale based on participant interviews. The scale assesses depressive symptomatology that occurred in participants during the week preceding each interview. Participants were rated on 10 items: Apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item was scored on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score was the sum of the scores of the 10 items and ranged from 0 to 60. A higher score indicates more depressive symptomatology. A negative change score indicates improvement.|Baseline to Week 10|Intent-to-treat population: All randomized participants who received at least 1 dose of placebo, vilazodone, or citalopram and who had a baseline and at least 1 post-baseline assessment of the MADRS total score.||Units on a scale||Standard Error|Least Squares Mean
687945|NCT01473368|Primary|Operational Taxonomic Units|"Core Microbiome includes control samples and baseline samples (Day -7 and Day 0) for antibiotic, probiotic, and combination groups. Data for Core microbiome for individual arms are not available.
Before Treatment: Average of Day -7 and Day 0 During Treatment: Average of Day 3, Day 7, Day 10, Day 13 After Treatment: Average of Day 21"|Day 0 to Day 21|||units||Standard Deviation|Mean
687946|NCT01473368|Primary|Prevalence of Escherichia in Stool|"Control arm was not assessed as there was no intervention for this group.
Before Treatment: Average of Day -7 and Day 0 During Treatment: Average of Day 3, Day 7, Day 10, Day 13 After Treatment: Average of Day 21"|Day -7 to Day 21|||percentage of total bacteria||Standard Deviation|Mean
687947|NCT01473368|Primary|Prevalence of Escherichia in Stool|"Control arm was not assessed as there was no intervention for this group.
Before Treatment: Average of Day -7 and Day 0 During Treatment: Average of Day 3, Day 7, Day 10, Day 13 After Treatment: Average of Day 21"|Day -7 to Day 21|||percentage of total bacteria||Standard Deviation|Mean
687948|NCT01473368|Primary|Prevalence of Escherichia in Stool|"Control arm was not assessed as there was no intervention for this group.
Before Treatment: Average of Day -7 and Day 0 During Treatment: Average of Day 3, Day 7, Day 10, Day 13 After Treatment: Average of Day 21"|Day -7 to Day 21|||percentage of total bacteria||Standard Deviation|Mean
687956|NCT01473160|Primary|Average Ocular Surface Temperature|Ocular surface temperature (OST) was recorded by the investigator using a dynamic, non-contact, infrared thermography camera. The average OST (encompassing the wear of a contact lens) was taken at the center of the cornea, at the temporal upper limbal area, and over the central 5 mm2 of the cornea, 2 seconds post-blink.|Up to 16 hours after lens insertion|All enrolled participants||Degrees Celsius||Standard Deviation|Mean
687957|NCT01473160|Primary|Average Tear Meniscus Height|The tear meniscus height, i.e., the distance between the line of reflection along the top of the tear prism to the edge of the eyelid, was measured by the investigator using a digital slit lamp.|Up to 16 hours after lens insertion|All enrolled participants||pixels||Standard Deviation|Mean
687958|NCT01473160|Primary|Pre-Lens Noninvasive Tear Break-Up Time|The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The time required for a dry spot to appear on the corneal surface after blinking is referred to as the tear film break-up time. Circular images were projected onto the corneal surface using a CA-1000 topographer, and the tear film reflection was observed on a 30-inch flat panel monitor. PL-NITBUT was recorded at the first sign of image distortion. Three measurements were taken and averaged together. A higher number represents a lengthening in the tear film break up time.|Up to 16 hours after lens insertion|All enrolled participants||seconds||Standard Deviation|Mean
687959|NCT01473160|Primary|Number of Participants With Corrected Visual Acuity of 0.0 or Better|Corrected visual acuity was measured with a digitized logMAR (logarithm of the minimum angle of resolution) chart. A logMAR acuity of 0.0 is considered normal distance eyesight.|Up to 16 hours after lens insertion|All enrolled participants||participants|||Number
687960|NCT01472939|Secondary|Time to Maximum Plasma Concentration (Tmax) of SSP-002358||Over 8 hours post-dose (week 2 or later)|Full Pharmacokinetic Subset consisted of a subset of subjects who underwent the detailed pharmacokinetic assessments. Subjects who vomited within the blood sampling period may have been excluded.||hours||Full Range|Median
687961|NCT01472939|Secondary|Steady State Maximum Plasma Concentration (Cmax) of SSP-002358|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administered.|Over 8 hours post-dose (week 2 or later)|Full Pharmacokinetic Subset consisted of a subset of subjects who underwent the detailed pharmacokinetic assessments. Subjects who vomited within the blood sampling period may have been excluded.||pg/ml||Standard Deviation|Mean
687962|NCT01472939|Secondary|Area Under the Steady-state Plasma Concentration-time Curve (AUC) of SSP-002358|Area under the plasma concentration versus time curve can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Over 8 hours post-dose (week 2 or later)|Full Pharmacokinetic Subset consisted of a subset of subjects who underwent the detailed pharmacokinetic assessments. Subjects who vomited within the blood sampling period may have been excluded.||pg*h/ml||Standard Deviation|Mean
687963|NCT01472939|Secondary|Change From Baseline in the Persistent Reflux Integrated Symptom Measurement (PRISM) Liquid and Food Domain Scores Over Weeks 5-8|PRISM is a 21 item patient-reported outcome instrument with 4 domains. Items are scored using various scales. Total score ranges from 0-100. Higher scores indicate more severe or frequent symptoms.|Baseline and over weeks 5-8|Full Analysis Set consisted of all subjects in the Safety Analysis Set who had at least 1 post-baseline value for the primary efficacy assessment. Safety Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.||units on a scale||Standard Error|Least Squares Mean
687964|NCT01472939|Secondary|Change From Baseline in Heartburn-Free Days Over Weeks 5-8||Baseline and over weeks 5-8|Full Analysis Set consisted of all subjects in the Safety Analysis Set who had at least 1 post-baseline value for the primary efficacy assessment. Safety Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.||percentage of days||Standard Error|Least Squares Mean
687965|NCT01472939|Primary|Change From Baseline in Percent Regurgitation-Free Days Over Weeks 5-8||Baseline and over weeks 5-8|Full Analysis Set consisted of all subjects in the Safety Analysis Set who had at least 1 post-baseline value for the primary efficacy assessment. Safety Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.||percentage of days||Standard Error|Least Squares Mean
687966|NCT01472874|Secondary|Zn Urine||Months 1,2,3,6,9,12 (mean)|||mcg/24hr||Standard Deviation|Mean
687967|NCT01472874|Secondary|Zn Urine||Pre Treatment (mean)|||mcg/24hr||Standard Deviation|Mean
687968|NCT01472874|Secondary|Cu Urine||Months 1,2,3,6,9,12 (mean)|||mcg/24hr||Standard Deviation|Mean
687969|NCT01472874|Secondary|Cu Urine||Pre Treatment (mean)|||mcg/24hr||Standard Deviation|Mean
687970|NCT01472874|Primary|Cu Serum||Months 1,2,3,6,9,12 (mean)|||mcg/24h||Standard Deviation|Mean
687971|NCT01472874|Primary|Cu Serum||Pre Treatment (mean)|||mcg/24h||Standard Deviation|Mean
687972|NCT01472874|Secondary|Albumin||Months 1,2,3,6,9,12 (mean)|||g/dL||Standard Deviation|Mean
687973|NCT01472874|Secondary|Albumin||Pre Treatment (mean)|||g/dL||Standard Deviation|Mean
687974|NCT01472874|Secondary|INR|The International Normalized Ratio (INR) is a standard way to describe the time it takes for blood to clot; an INR range of 0.8 to 1.2 is considered normal for a healthy person who is not using oral anticoagulant therapy|Months 1,2,3,6,9,12 (mean)|||international normalized ratio||Standard Deviation|Mean
687975|NCT01472874|Secondary|INR|The International Normalized Ratio (INR) is a standard way to describe the time it takes for blood to clot; an INR range of 0.8 to 1.2 is considered normal for a healthy person who is not using oral anticoagulant therapy|Pre Treatment (mean)|||international normalized ratio||Standard Deviation|Mean
687976|NCT01472874|Primary|ALT|Alanine transaminase|Months 1,2,3,6,9,12 (mean)|||U/L||Standard Deviation|Mean
687977|NCT01472874|Primary|ALT|Alanine transaminase|Pre Treatment (mean)|||U/L||Standard Deviation|Mean
687978|NCT01472835|Secondary|Satisfaction|5-point Likert scale. The scale is from 1-5. 1 being very unsatisfied and 5 being very satisfied.|1 day|||units on a scale||Standard Deviation|Mean
687979|NCT01472835|Secondary|Oswestry Disability Index|Measure of functional capacity on a scale ranging from 0% to 100%, with 0% signifying no disability|1-month|||units on a scale||Standard Deviation|Mean
687980|NCT01472835|Secondary|Procedure-related Pain Score|0-10 pain scale, with 0 being no pain and 10 being the worst pain imaginable|1 day|||units on a scale||Standard Deviation|Mean
710427|NCT00161382|Secondary|Attitudes||Measured throughout the study||||||
687986|NCT01472822|Secondary|Changes in Lysholm Index Score|"Lysholm index score total score (score 0–100) was measured in study visit 1(0 week) and visit 3(12 week).
The original index consists of 9 Questions(Limp, Assive devices, Up stair, Giving way, Sauat, Sit down&up, Cripitation, Swelling, Pain). Lysholm index score total score summed to form a score ranging from 0 (worst) to 100 (best)."|12 weeks|per protocol analysis||units on a scale(0-100)||Standard Deviation|Mean
687987|NCT01472822|Primary|Changes in WOMAC (Western Ontario and McMaster University Osteoarthritis Index) Totol Score|"WOMAC(Western Ontario and McMaster University Osteoarthritis Index) total score (score 0–96) was measured in study visit 1(0 week) and visit 3(12 week).
The original index consists of 24 Questions. Individual question response is assigned a score of between 0 (none) to 4 (extreme) and summed to form a score ranging from 0 (best) to 96 (worst)."|12 weeks|per protocol analysis||Score||Standard Deviation|Mean
687988|NCT01472562|Secondary|2-year Progression-free Survival|PFS will be defined as the time from first treatment day until objective or symptomatic progression or death.|30 months|||percentage of patients||95% Confidence Interval|Number
687989|NCT01472562|Primary|Overall Response Rate|The primary endpoint of overall response rate will be estimated and a 95% confidence interval will be estimated via binomial proportions.|30 months|||percentage of patients||95% Confidence Interval|Number
687990|NCT01472432|Secondary|iNOS|The factor is assessed by immunoblot analysis (commercial kits). Arbitrary unit of measure are used to evaluate iNOS concentration. Higher values represent more factor.|3 months|The analysis was not performed because an inadequate amount of biopsy tissue|||||
687991|NCT01472432|Secondary|VEGF-R1 (Total and Phosphorylated Form), VEGF-R2 (Total and Phosphorylated Form)|The factor is assessed by immunoblot analysis (commercial kits). Arbitrary unit of measure are used to evaluate VEGF-R1 concentration. Higher values represent more factor.|3 months|The analysis was not performed because an inadequate amount of biopsy tissue|||||
687992|NCT01472432|Secondary|VEGF|The factor is assessed by immunoblot analysis (commercial kits).Arbitrary unit of measure are used to evaluate VEGF concentration. Higher values represent more factor.|3 months|||arbitrary units||Inter-Quartile Range|Median
687993|NCT01472432|Secondary|HIF-1α|The factor is assessed by immunoblot analysis (commercial kits). Arbitrary unit of measure are used to evaluate HIF-1α concentration. Higher values represent more factor.|3 months|||arbitrary units||Inter-Quartile Range|Median
687994|NCT01472432|Primary|Capillary Density|"Biopsy is performed from the periphery of the ulcer, before and after treatment with vildagliptin, in order to evaluate the above referred outcome.
Capillary density is measured using immunohistochemistry"|3 months of treatment with vildagliptin|||capillaries/mm2||Inter-Quartile Range|Median
687995|NCT01472432|Primary|Full Epithelialization of the Wound|"Biopsy is performed from the periphery of the ulcer, before and after treatment with vildagliptin, in order to evaluate the above referred outcome.
Optic microscopy is used to evaluate the epithelialization of the wound."|3 months of treatment with vildagliptin|||participants|||Number
687996|NCT01472380|Primary|Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-infinity]|The area under the plasma concentration versus time curve from time 0 to infinity. [AUC(0 to infinity)] was calculated as the sum of AUC (0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant for efavirenz.|serial pharmacokinetic blood samples drawn immediately prior to dosing on Days 1 and 31 and then 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 48, 72, 96, and 120 hours after dose administration|28 of 30 subjects completed the entire study and had sufficient data to calculate at minimum the area under the plasma concentration versus time curve from time 0 to infinity for efavirenz.||h*ug/mL||Standard Deviation|Mean
687997|NCT01472380|Primary|Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time 0 to Time t[AUC(0-t)]|The area under the plasma concentration versus time curve from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule for efavirenz|serial pharmacokinetic blood samples drawn immediately prior to dosing on Days 1 and 31 and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 48, 72, 96, and 120 hours after dose administration|28 of 30 subjects completed the entire study and had sufficient data to calculate at minimum the area under the plasma concentration versus time curve from time 0 to the time t of the last quantifiable concentration (AUC0-t) for efavirenz.||h*ug/mL||Standard Deviation|Mean
687998|NCT01472380|Primary|Pharmacokinetics: Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that the drug reaches in the plasma for efavirenz|serial pharmacokinetic blood samples drawn immediately prior to dosing on Days 1 and 31 and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 48, 72, 96, and 120 hours after dose administration|28 of 30 subjects completed the entire study and had sufficient data to calculate at minimum the maximum concentration (Cmax)for efavirenz.||ug/mL||Standard Deviation|Mean
687999|NCT01472341|Primary|Homeostatic Model Assessment Fasting Beta Cell Function (HOMA % B) According to Quartiles of Proinsulin/Insulin (PI/I) Ratio|HOMA is a method used to quantify insulin resistance (a condition in which natural hormone insulin becomes less effective in lowering blood sugars) and beta-cell (specialized cells in the pancreas producing insulin) function. HOMA uses fasting plasma insulin and glucose concentrations to estimate steady state pancreatic beta cell function (%B) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. HOMA%B was defined as 20 x fasting insulin (mU/L)/fasting glucose (mmol/L) - 3.5. Beta-cell dysfunction was evaluated by calculating the PI/I ratio, which estimates the capacity of beta cells to convert proinsulin to insulin and may represent an acceptable method to indicate the degree of beta-cell secretion.|Baseline|Participants with fasting plasma insulin and glucose concentration assessments at baseline.||Percentage Beta Cell Function||Standard Deviation|Mean
688000|NCT01472341|Primary|Change From Baseline in Proinsulin/Insulin (PI/I) Ratio at 4 Years|Proinsulin is the prohormone precursor to insulin made in the beta cells of the islets of Langerhans, specialized regions of the pancreas. A raised proinsulin-to-insulin ratio due to impaired processing of proinsulin is an early marker of beta cell dysfunction. Beta-cell dysfunction was evaluated by calculating the PI/I ratio, which estimates the capacity of beta cells to convert proinsulin to insulin and may represent an acceptable method to indicate the degree of beta-cell secretion.|Baseline and Year 4|Participants who had laboratory parameters at Baseline and at Year 4.||PI/I||Standard Deviation|Mean
688012|NCT01472185|Secondary|Change From Baseline in Fasting Serum Glucose at Week 24|The average (mean) change from baseline in fasting serum glucose at Week 24 was analyzed.|Baseline; Week 24|Participants in the Full Analysis Set with available data were analyzed.||mg/dL||Standard Deviation|Mean
688001|NCT01472341|Primary|Change From Baseline in Homeostatic Model Assessment Fasting Beta Cell Function (HOMA % B) at 4 Years|HOMA is a method used to quantify insulin resistance (a condition in which natural hormone insulin becomes less effective in lowering blood sugars) and beta-cell (specialized cells in the pancreas producing insulin) function. HOMA uses fasting plasma insulin and glucose concentrations to estimate steady state pancreatic beta cell function (%B) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. HOMA%B was defined as 20 x fasting insulin (mU/L)/fasting glucose (mmol/L) - 3.5.|Baseline and 4 years|Participants who had laboratory parameters at Baseline and at Year 4.||Percentage of Beta Cell Function||Standard Deviation|Mean
688002|NCT01472289|Secondary|Number of Participants Able to Walk From Baseline to 12 Months as Measured by 6-Minute Walk Test|Subjects were analyzed to see if they were able to walk any distance and the distance covered by patients in 6 minutes was measured to assess the functional changes from baseline. The American Thoracic Society has issued guidelines for the 6-minute walk test (6 MWT). The 6 MWT is safe, easy to administer, well tolerated, and reflects activities of daily living.|Baseline, 1, 3, 6 and 12 months|Efficacy measures were established by assessing CLI symptoms known to be reliable and valid. The efficacy endpoints were analyzed on per protocol (PP) basis (N=14).||Participants|||Number
688003|NCT01472289|Secondary|Clinical Evaluation for the Presence of Ulcer and/or Gangrene in the Affected Limb From Baseline to 12 Months|Evaluation of the integument for ulceration, gangrene and other skin changes in the affected limb was performed at baseline and follow-up visits at 1 month, 3 months, 6 months, and 12 months.The ulceration and gangrene in the affected limb of the subjects was evaluated by visual clinical inspection.|Baseline, 1, 3, 6 and 12 months|Efficacy measures were established by assessing CLI symptoms known to be reliable and valid. The efficacy endpoints were analyzed on per protocol (PP) basis (N=14).||Participants|||Number
688004|NCT01472289|Secondary|Change in Rest Pain and Intermittent Claudication Assessment From Baseline to 12 Months|"Rest pain is a burning sensation felt at rest, usually in the skin of the foot. It is a symptom of critical ischemia due to severe, chronic, and occlusive peripheral arterial disease (PAD). While, Intermittent Claudication is a crampy leg pain that occurs during exercise, especially walking. The pain is due to the insufficient blood flow in the legs (caused by blocked arteries). Intermittent claudication is the most prominent symptom of PAD.
Both Rest Pain assessment and Intermittent Claudication assessment was performed through Visual Analog Scale or Visual Analogue Scale (VAS). VAS is a psychometric (self-report) response scale that ranges from 0 to 10, where a mark of zero indicates no pain and a mark of 10 indicates worst possible pain."|Baseline, 1, 3, 6 and 12 months|Efficacy measures were established by assessing CLI symptoms known to be reliable and valid. The efficacy endpoints were analyzed on per protocol (PP) basis (N=14).||scores on a scale||Standard Deviation|Mean
688005|NCT01472289|Secondary|Measurement of Change in Transcutaneous Oxygen Pressure (TcPO2) From Baseline to 12 Months|TcPO2 was used to assess the partial pressure (tension) of oxygen in the capillaries of tissues of lower limbs. It was measured by applying a special set of electrodes to the skin. These electrodes contain photoelectric sensors capable of detecting the specific wavelengths of radiation emitted by oxygenated versus reduced hemoglobin.|Baseline, 1, 3, 6 and 12 months|The efficacy endpoints were analyzed on per protocol (PP) basis (N=14).||mmHg||Standard Deviation|Mean
688006|NCT01472289|Secondary|Measurement of Mean Change in Ankle Brachial Index From Baseline to 12 Months|ABI was used to provide a measure of blood flow in the lower limbs. It is the ratio of the blood pressure in the lower limbs to the blood pressure in the upper limbs. Compared to the upper limb, lower blood pressure in the lower limb is an indication of blocked arteries (peripheral vascular disease). The ABI was calculated by dividing the systolic blood pressure at the ankle by the systolic blood pressures in the arm. ABI test was performed at baseline, 1 month, 3 months, 6 months, and 12 months.|Baseline, 1, 3, 6 and 12 months|Efficacy measures were established by assessing CLI symptoms known to be reliable and valid. The efficacy endpoints were analyzed on per protocol (PP) basis (N=14).||Ratio||Standard Deviation|Mean
688007|NCT01472289|Secondary|Degree of Angiogenesis Measured by the Number of Collateral Blood Vessels Formed at 12 Months|Measurement of blood supply facilitated by the formation of collateral blood vessels assessed by CT angiography after the procedure.|Baseline and 12 month|Efficacy measures were established by assessing CLI symptoms known to be reliable and valid. The efficacy endpoints were analyzed on per protocol (PP) basis (N=14).||Number of Vessels||Standard Deviation|Mean
688008|NCT01472289|Primary|Number of Participants With Adverse Events as a Measure of Safety and Major Limb Amputation Free Survival Post BMMNC Administration|The Primary objective of this study was to determine the safety of intramuscular administration of concentrated autologous BMMNCs harvested, and processed using the Res-Q 60 technology (a point-of-care system). Safety measurements included close vigilance for major limb amputation free survival at 1, 3, 6 and 12 months post BMMNCs administration and stringent reporting of AEs and SAEs.|1, 3, 6 and 12 Months|All the safety end points in the study were analyzed on the ITT population. Out of 17 subjects, adverse events were reported for seven subjects. Of the seven subjects, three underwent major amputation, two reported minor amputation, and two died due to cardiac arrest (unrelated death). Furthermore, major limb amputation free survival rate was 14.||participants|||Number
688009|NCT01472185|Secondary|Change From Baseline in Incremental Change of 2-hour Postprandial Serum Glucose at Week 24|The average (mean) change from baseline in incremental change of 2-hour postprandial serum glucose at Week 24 was analyzed.|Baseline; Week 24|Participants in the Mixed Meal Tolerance Test (MMTT) Full Analysis Set with available data were analyzed.||mg/dL||Standard Deviation|Mean
688010|NCT01472185|Secondary|Change From Baseline in 2-hour Postprandial Serum Glucose at Week 24|"The average (mean) change from baseline in 2-hour postprandial serum glucose at Week 24 was analyzed.
Mixed Meal Tolerance Test (MMTT) Full Analysis Set: randomized participants who received at least one dose of study treatment with a baseline and at least one postbaseline measurement of serum glucose at time [T] = 120 minutes during the MMTT, administered under fasting conditions, excluding participants with major eligibility protocol violations and analyzed based on the randomized treatment regardless of actual treatment received."|Baseline; Week 24|Participants in the Mixed Meal Tolerance Test (MMTT) Full Analysis Set with available data were analyzed.||mg/dL||Standard Deviation|Mean
688011|NCT01472185|Secondary|Percentage of Participants With HbA1c < 7% at Week 24||Week 24|Participants in the Full Analysis Set with Baseline HbA1c ≥ 7% and available data were analyzed.||percentage of participants|||Number
708916|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 24||Month 24|||L||Standard Error|Mean
688013|NCT01472185|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|The average (mean) change from baseline in HbA1c at Week 24 was analyzed.|Baseline; Week 24|Participants in the Full Analysis Set (randomized participants who received ≥ 1 dose of study treatment with a baseline and at least one postbaseline measurement of HbA1c, excluding subjects with major eligibility violations and analyzed based on the randomized treatment regardless of actual treatment received) with available data were analyzed.||percent of HbA1c in blood||Standard Deviation|Mean
688014|NCT01471782|Secondary|Serum Cytokine Peak Levels|The activation of immune effector cells was monitored by the measurement of peripheral blood cytokine levels including interleukin (IL)-2, IL-4, IL-6, IL-10, tumor necrosis factor-alpha (TNF-α) and interferon gamma (IFN-ɣ) using cytometric bead assays. The limit of detection of the assay (LOD) was 20 pg/mL and the lower limit of quantification (LLOQ) was 125 pg/mL. Data below LOD were set to 10 pg/mL while data < LOQ and > LOD were reported as measured.|Cycle 1 and 2 day 1 (prior to infusion, 2 and 6 hours after infusion start), day 2 and day 3.|Phase 1 full analysis set participants with available data||pg/mL||Standard Deviation|Mean
688015|NCT01471782|Secondary|Number of Participants Who Developed Anti-blinatumomab Antibodies|Antibodies to blinatumomab were detected using an electrochemiluminescence (ECL)-based assay.|Predose up until 30 days after last dose of study medication; median treatment duration was 28 days.|Full analysis set||participants|||Number
688016|NCT01471782|Secondary|Percentage of Participants Who Received an Allogeneic Hematopoietic Stem Cell Transplant During Blinatumomab Induced Remission|The percentage of participants who received allogeneic hematopoietic stem cell transplantation (HSCT) while in remission due to treatment with blinatumomab during the first two cycles, and received no further anti-leukemic medication before HSCT.|Up to the data cut-off date of 12 January 2015; Maximum duration on study was 24 months in phase 1 and 15 months for phase 2.|Full analysis set||percentage of participants||95% Confidence Interval|Number
688017|NCT01471782|Secondary|Relapse-free Survival|"Relapse-free survival (RFS) was assessed for participants who achieved a complete remission during the core study and was measured from the time the participant first achieved remission until first documented relapse or death due to any cause. Participants without a documented relapse (hematological or extramedullary) or who did not die were censored at the time of their last bone marrow assessment or their last survival follow-up visit confirming remission.
Relapse free survival was estimated using Kaplan-Meier methods and the median observation time was calculated by the reverse Kaplan-Meier method."|Up to the data cut-off date of 12 January 2015; median observation time was 23.5 months for phase 1 and 11.5 months for phase 2.|Full analysis set with complete remission||months||95% Confidence Interval|Median
688018|NCT01471782|Secondary|Overall Survival|"Overall survival (OS) was measured for all participants from the first treatment of blinatumomab until death due to any cause or the date of the last follow-up. Participants who did not die were censored on the last documented visit date or the date of the last contact when the patient was last known to have been alive. For patients who withdrew their informed consent only information until the date of withdrawal was analyzed.
Overall survival was estimated using Kaplan-Meier methods. The median follow-up time with respect to overall survival was calculated by the reverse Kaplan-Meier method."|Up to the data cut-off date of 12 January 2015; median observation time was 23.5 months for phase 1 and 11.6 months for phase 2.|Full analysis set||months||95% Confidence Interval|Median
688019|NCT01471782|Secondary|Time to Hematological Relapse (Duration of Response)|"Time to hematological relapse was measured only for participants in remission and was measured from the time the participant first achieved remission until first documented relapse or death due to disease progression. Participants without a documented relapse (hematological or extramedullary) and who did not die were censored at the time of their last bone marrow assessment or their last survival follow-up visit confirming remission. Participants who died without having reported hematological relapse or without showing any clinical sign of disease progression were censored on their date of death.
Hematological relapse is defined as the proportion of blasts in bone marrow > 25% following documented remission, or extramedullary relapse.
Time to hematological relapse was analyzed by Kaplan-Meier methods and the median observation time was calculated by the reverse Kaplan Meier method."|Up to the data cut-off date of 12 January 2015; median observation time was 23.5 months for phase 1 and 11.5 months for phase 2.|Full analysis set with complete remission||months||95% Confidence Interval|Median
688020|NCT01471782|Secondary|Steady State Concentration of Blinatumomab|"Blinatumomab serum concentrations were quantified in all patients during the first 2 treatment cycles in the phase 1 part of the study only. Blinatumomab concentrations were quantified using a validated bioassay, the lower limit of quantification was 50 pg/mL. Steady state serum concentration (Css) was presumed on day 1, approximately 5 half-lives after the start of the IV infusion.
The steady state serum concentration reported is the mean of the observed concentrations collected after during cycles 1 and 2."|Cycles 1 and 2 during the IV infusion on day 3 (at least 48 hours after start of infusion) and days 8, 15 and 22 (steady state) and day 29 at End of Infusion (EoI) and 2, 4, and 8 hours after EoI for ages ≥ 2 years.|Phase 1 participants with available blinatumomab concentration data||pg/mL||Standard Deviation|Mean
688021|NCT01471782|Secondary|Number of Participants With Adverse Events|"The severity (or intensity) of adverse events (AEs) was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), v4.03 and according to the following:
Grade 1 - Mild adverse event; Grade 2 – Moderate adverse event; Grade 3 – Severe and undesirable adverse event; Grade 4 - Life-threatening or disabling adverse event; Grade 5 - Death. The investigator used medical judgment to determine if there was a causal relationship (ie, related, unrelated) between an adverse event and blinatumomab."|From the start of the first infusion to 30 days after the end of the last infusion in the core study or from the start of the first retreatment cycle infusion to 30 days after the end of the last retreatment cycle, median treatment duration was 28 days|Full analysis set||participants|||Number
688022|NCT01471782|Primary|Percentage of Participants With Complete Remission in the First Two Cycles|"Hematological assessments were performed from bone marrow biopsy samples. All hematological assessments of bone marrow were reviewed in a central laboratory. Complete remission (CR) was defined as
M1 bone marrow (bone marrow blasts < 5%)
No evidence of circulating blasts or extra-medullary disease
Complete remission includes participants with incomplete recovery of peripheral blood counts."|Cycles 1 and 2 (12 weeks)|The full analysis set includes all participants who received any infusion of blinatumomab.||percentage of participants||95% Confidence Interval|Number
708917|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 18||Month 18|||L||Standard Error|Mean
688023|NCT01471782|Primary|Phase I: Number of Participants With Dose-limiting Toxicities (DLTs)|"The maximum tolerated dose (MTD) was defined as one or fewer out of 6 participants experiencing a dose limiting toxicity (DLT) or the maximum administered dose (MAD).
A dose limiting toxicity is any Grade ≥ 3 adverse event related to study drug, Grade 3 fatigue, headache, insomnia, fever, hypotension or infection were not considered dose limiting toxicities. Laboratory parameters of Grade ≥ 3 but not considered as clinically relevant and/or responding to routine medical management, thrombocytopenia, leukopenia (including neutropenia and lymphopenia), and anemia were not considered dose limiting toxicities."|Cycle 1, 28 days|Participants in the Phase 1 dose evaluation/escalation part of the study||participants|||Number
688024|NCT01471691|Secondary|Total Number of Ranibizumab Injections||month 12||||||
688025|NCT01471691|Secondary|Excess Foveal Thickness||Month 6 and 12||||||
688026|NCT01471691|Secondary|Percentage of Patients With CFT Less Than 300um||Month 6 and 12||||||
688027|NCT01471691|Secondary|Change in Mean Best Corrected Visual Acuity From Baseline||months 1-12||||||
688028|NCT01471691|Secondary|Mean Change From Baseline in Center Point Thickness||months 1-12||||||
688029|NCT01471691|Primary|Mean Change From Baseline BCVA|Vision was measured using a standard ETDRS chart at baseline and each subsequent monthly visit.|Baseline to month 6|||Letters (ETDRS chart)||Standard Deviation|Mean
688030|NCT01471639|Secondary|Adverse Event/Side Effects|Safety assessed by reporting of all adverse events and side effects.|Up to 4 hours|Participants who reported discomfort or unpleasant feeling associated with use of intranasal ketorolac||Participants|||Count of Participants
688031|NCT01471639|Primary|Efficacy of Intranasal Ketorolac on Numeric Pain Scale|Change in numeric rating scale after receiving intranasal ketorolac. 0 (no pain) - 10 (worst possible pain)|up to 4 hours|Improvement in pain score rating among participants rating from baseline pain scores, 20 minutes, 40 minutes, 1 hour, 2 hour, 3 hour and 4 hour post dose. Pain scale ranging from 0 (no pain) - 10 (worst possible pain)||Participants|||Count of Participants
688032|NCT01471626|Primary|Quality of Polysomnographic Recordings|Quality of recordings will be graded according to Redline S et al (SLEEP 1998): Unsatisfactory, poor, fair, good, very good,excellent. Unsatisfactory and poor recordings are considered as failures.|1 week|||percentage of recording failure|||Number
688033|NCT01471574|Secondary|Number of Participants Who Died and With Serious Adverse Event (SAEs), Grade 3 to 4 Adverse Events (AEs), and AEs Leading to Discontinuation|Adverse event was defined as any new unfavorable symptom, sign, or disease or worsening of a pre-existing condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threating, an important medical event, or a congenital anomaly/birth defect; or required prolonged hospitalization. HAART=highly active antiretroviral therapy.|From Day 1 to 7 days post last dose of study treatment (up to Week 48)|The analysis was performed in all participants who received at least 1 dose of study drug.||Participants|||Number
688034|NCT01471574|Secondary|Percentage of Participants With Sustained Virologic Response (SVR12) by rs12979860 Single Nucleotide Polymorphism (SNP) in the IL28B Gene|Percentages calculated as number of responders/number who received treatment.|Follow-up Week 12|The analysis was performed in all participants who received at least 1 dose of study therapy. Here 'n' signifies number of participants evaluable at the specified time-point.||Percentage of participants||95% Confidence Interval|Number
688035|NCT01471574|Secondary|Percentage of Participants Who Received Highly Active Antiretroviral Therapy (HAART), Maintained HIV RNA <40 Copies/mL, and Experienced Confirmed HIV RNA ≥400 Copies/mL|Participants who received HAART, maintained HIV RNA <40 copies/mL, and experienced confirmed HIV RNA ≥ 400 copies/mL were determined.|End of treatment (up to Week 48)|The analysis was performed in all participants who received at least 1 dose of study therapy||Percentage of participants||95% Confidence Interval|Number
688036|NCT01471574|Secondary|Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Lower Than the Lower Limit of Quantitation (LLOQ), Target Not Detected (TND)|Participants who achieved HCV RNA levels lower than the LLOQ, TND. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. HAART=highly active antiretroviral therapy.|Week 1, 2, 4, 6, 8, and 12 and at both Weeks 4 and 12; end of treatment; and follow-up Weeks 12 and 24|The analysis was performed in all participants who received at least 1 dose of study therapy. On-treatment virologic response rates were not significantly different from one another among 30 mg, 60 mg, and 90 mg groups in the HAART cohort, thus these groups were combined as per pre-specified analysis plan.||Percentage of participants|||Number
688037|NCT01471574|Secondary|Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Lower Than The Lower Limit of Quantitation (LLOQ), Target Detected (TD) or Target Not Detected (TND)|Participants who achieved HCV RNA levels lower than the LLOQ i.e., 25 IU/ml, TD or TND. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. HAART=highly active antiretroviral therapy.|Week 1, 2, 4, 6, 8, 12 and at both Weeks 4 and 12; end of treatment; and follow-up Weeks 12 and 24|The analysis was performed in all participants who received at least 1 dose of study therapy. On-treatment virologic response rates were not significantly different from one another among 30 mg, 60 mg, and 90 mg groups in the HAART cohort, thus these groups were combined as per pre-specified analysis plan.||Percentage of participants|||Number
688038|NCT01471574|Primary|Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)|SVR12 was defined as hepatitis C virus (HCV) values lower than the lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. HAART=highly active antiretroviral therapy. SVR12 was defined as hepatitis C virus (HCV) values lower than the lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. HAART=highly active antiretroviral therapy.|Follow-up Week 12|The analysis was performed in all participants who received at least 1 dose of study therapy.||Percentage of participants||95% Confidence Interval|Number
688039|NCT01471379|Secondary|Dose Related Incremental Benefit in Pain Reduction Based on VAS|The investigator was looking to see if, for group A, when increased from 50 mg BID to 100 mg BID there is significant improvement of pain scores i.e. 30% pain reduction, and for group C, if there was significant improvement of pain scores when switched from placebo to 50 mg BID of Milnacipran|12 Weeks|||percentage of participants|||Number
688040|NCT01471379|Secondary|Treatment Efficacy Questionnaire (TEQ)|Treatment Efficacy Questionnaire is a measure of treatment effectiveness. The score ranges from 1 to 48, 1 is minimum score and 48 is the maximum score. The investigators was looking to see if the Milnacipran treatment groups have a higher proportion of subjects with significant improvement in efficacy, judged as a TEQ score of >28, compared to placebo group.|Twelve Weeks|Only one subject was enrolled and was analyzed even though subject did not complete the study.||percentage of subject with score >28|||Number
688041|NCT01471379|Secondary|Subject Self Reported Adequate Relief of Pain|The study sought to determine if the Milnacipran arms had a greater proportion of adequate relief over the placebo group. Subjects were asked to answer ‘yes’ or ‘no’ as to whether or not they had adequate relief of pain due to irritable bowel syndrome.|Twelve Weeks|||percentage of participants|||Number
688042|NCT01471379|Secondary|Quality of Life ( IBS-QOL)|After six weeks of treatment with Milnacipran, treatment groups were compared with placebo for clinically significant improvement in IBS-QOL. 11 point reduction in IBS-QOL compared to baseline was considered as clinically significant improvement.|Six Weeks||||||
688043|NCT01471379|Primary|Number of Participants With Pain Response|Visual Analog Scale (VAS) scores (range 0-100 mm; 0 = none, 100 = worst pain) were recorded for pain before the beginning of the study, at 6 weeks of treatment and at the end visit i.e. 10 weeks. Ideally, VAS would have been administered at the 12th week; however, subject was terminated at the 10th week visit. A positive pain response (ie pain relief) was defined as >30% decrease in the VAS score between baseline and the final study visit.|Twelve Weeks|||participants|||Number
688044|NCT01471353|Secondary|Correlative Tissue Analysis|Exploratory tissue analysis in patients receiving sorafenib plus capecitabine|6 months||12/2018||||
688045|NCT01471353|Secondary|Toxicity|Evaluate acute toxicity of treatment. The toxicity assessments were graded by the NCI CTCAE (Clinical Trial Common Adverse Event) grading system – a global standard for assessments of clinical and laboratory toxicities. All toxicities are scored 1(mild) through 5 (death related to the event) based upon well-defined and reproducible definitions.|12 months|||percentage of participants|||Number
688046|NCT01471353|Secondary|Time to Progression|Time to disease progression while on and/or after treatment complete|up to 12 months||12/2018||||
688047|NCT01471353|Secondary|Response Rate|Measure response rate to treatment|3 months||12/2018||||
688048|NCT01471353|Secondary|Overall Survival|Evaluate overall survival after treatment.|5 years|||days||95% Confidence Interval|Median
688049|NCT01471353|Primary|Sorafenib Activity|Determine activity of sorafenib plus capecitabine on progression free survival (PFS) in patients with advanced colorectal cancer. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|2 years|||days||95% Confidence Interval|Median
688050|NCT01471197|Secondary|Number of Participants With Deaths, Adverse Events (AEs), Serious AEs (SAEs) and AEs Leading to Discontinuation - All Treated Participants|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. Participants were evaluated from Day 1 (first day of treatment with study drug) to the date of the last participant, last visit of the study.|Day 1 to Date of last patient, last visit, approximately 7 months after study started.|All participants who received at least one dose of study drug.||participants|||Number
688051|NCT01471197|Secondary|Number of Participants Who Died Within 30 Days and 31 Days After Last Dose - All Treated Participants|Due to study termination, the categories presented below are deaths occurring within 30 days of last dose and deaths occurring within 32 days of last dose. If the study had not been terminated early, the categories presented would have been 30 days and 90 days after last dose.|Day 1 of Treatment to Date of Death, up to last patient, last visit, approximately 7 months after study started.|All participants who were randomized and treated with at least one dose of either study drug.||participants|||Number
688052|NCT01471197|Primary|Overall Survival of Participants During the Study - All Treated Participants|Overall survival (OS) was defined as the time from the date of randomization until the date of death. For those participants who did not die by the time the study was terminated and last patient, last visit occurred, OS was censored (+) on the last date the participant was known to be alive. OS is presented below in increasing monthly categories of survival. OS analysis was to be performed when a total of approximately 132 deaths were observed but due to the early termination of the study, statistical analyses were not performed.|Date of Randomization to date of death, up to last patient, last visit, approximately 7 months after study started|All participants who received at least one dose of either study drug.||participants|||Number
688053|NCT01471171|Secondary|Change From Baseline in Intensity of Dyspnoea|Change from baseline in intensity of dyspnoea based on the Borg CR10 Scale® (ranging from '0'=nothing at all to '10'=extremely strong/maximal dyspnoea, the highest possible numerical value) at isotime during constant work rate cycle ergometry after 3 weeks of treatment.|Week 3|Intention-to-Treat (ITT) population: all randomised patients who took at least one dose of investigational medicinal product, and had at least a baseline and one post-dose corresponding assessment value of the primary efficacy variable in one of the 2 treatment periods. 2 patients from the safety population were excluded from the ITT population.||Units on a scale||Standard Error|Least Squares Mean
688054|NCT01471171|Secondary|Change From Baseline in Trough Inspiratory Capacity (IC) (Litres)|Change from baseline in trough IC after 3 weeks of treatment|Week 3|Intention-to-Treat (ITT) population: all randomised patients who took at least one dose of investigational medicinal product, and had at least a baseline and one post-dose corresponding assessment value of the primary efficacy variable in one of the 2 treatment periods. 2 patients from the safety population were excluded from the ITT population.||Litres||Standard Error|Least Squares Mean
688070|NCT01470469|Primary|Change From Baseline in Weight at up to 12 Weeks||Baseline and up to 12 weeks|Safety Analysis Set consisted of all subjects who had taken at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||kg||Standard Deviation|Mean
708918|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 18||Month 18|||L||Standard Error|Mean
688055|NCT01471171|Primary|Change From Baseline in Endurance Time (Seconds)|Change from baseline in endurance time during constant work rate cycle ergometry to symptom limitation at 75% of Maximum Work load (Wmax) after 3 weeks of treatment.|Week 3|Intention-to-Treat (ITT) population: all randomised patients who took at least one dose of investigational medicinal product, and had at least a baseline and one post-dose corresponding assessment value of the primary efficacy variable in one of the 2 treatment periods. 2 patients from the safety population were excluded from the ITT population.||Seconds||Standard Error|Least Squares Mean
688056|NCT01471041|Secondary|Arteriovenous Fistula Cannulation Complications While Using the Venous Window Needle Guide|Frequency of complications occuring when cannulating the arteriovenous fistula through the Venous Window Needle Guide|6 months|||participants|||Number
688057|NCT01471041|Primary|Use of Venous Window Needle Guide to Obtain Arteriovenous Access for Hemodialysis|Successful cannulation of arteriovenous fistula through the VWNG device and successful hemodialysis achieved within 3 months from index procedure.|3 months|||participants|||Number
688058|NCT01471015|Primary|The Pharmacokinetic Profile of Darbe After the Second Dose.|"The pharmacokinetic profile of Darbe will be determined using population pharmacokinetic sampling in which babies will be randomized to have blood drawn at different intervals. A second dose of Darbe will be given at 7 days of age, and serum drug levels will be obtained at 12, 18, 24, and 36 hours post second dose. Area under the plasma concentration versus time curve (AUC) will be used."|For 36 hours after second dose|||AUC (h*mU/L)||Inter-Quartile Range|Median
688059|NCT01471015|Primary|The Pharmacokinetic Profile of Darbe After the First Dose During Cooling|"The pharmacokinetic profile of Darbe wil be determined using population pharmacokinetic sampling in which babies will be randomized to have blood drawn at different intervals. Serum levels will be drawn at 4,12, 18, 24, 36, 60, and 72 hours post initial dose. Area under the plasma concentration versus time curve (AUC) will be used."|For 72 hours after first dose|||AUC (h*mU/L)||Inter-Quartile Range|Median
688060|NCT01471015|Secondary|Number of Participants With Adverse Events.|"Potential adverse events such as (but not limited to) alterations in blood pressure, secondary infections, neutropenia, thrombotic/vascular events, hematologic events (platelets, Hct level, polycythemia), and hepatic/renal function that are outside of normal range for the study population.
Complications associated with HIE or cooling therapy will not be considered an AE for this study. AEs reported to be associated with cooling include: bleeding/thrombosis, persistent pulmonary hypertension of the newborn (PPHN), skin changes, arrhythmia, and persistent acidosis."|30 days or until hospital discharge|||participants|||Number
688061|NCT01470859|Secondary|Patients With Clinical Improvement as Evaluated by Global Impression Scale (CGI).|"Patients with a score <= 2 (very much or much improved in relation to baseline) are considered as clinically improved.
The numbers of participants with clinical improvement are reported here. The completion of dosage titration within 10 weeks after baseline (visit 2) and 1 year after baseline (final visit)"|twice, at 10 weeks(V2) and 1 year(V5)|||participants|||Number
688062|NCT01470859|Secondary|Hoehn&Yahr (H&Y) Staging|"The Hoehn and Yahr scale is a commonly used scale for describing how the symptoms of Parkinson's disease progress and the disease stages. Bigger numbers indicate more symptoms and disease progression. H&Y stage range from 0-5; the greater, the more severe.
The H&Y stages of patients were evaluated at baseline (1st visit, V1), and 1 year after baseline (final visit, V5)."|twice baseline and 1 year|||units on a scale||Standard Deviation|Mean
688063|NCT01470859|Secondary|Parkinson's Disease Questionnaire (PDQ39)|"The PDQ39 score was assessed at baseline (1st visit, V1) and 1 year after baseline (final visit, V5).
PDQ39 score ranges from 0-156 (0-4 each item); the more score, the more severe."|twice baseline and 1 year|||units on a scale||Standard Deviation|Mean
688064|NCT01470859|Secondary|Unified Parkinson's Disease Rating Score (UPDRS II, III)|baseline (1st visit, V1), completion of dosage titration within 10 weeks after baseline (2nd visit, V2), 1 year after baseline (final visit, V5) UPDRS II score 0-52 (13 items); UPDRS III score 0-56 (14 items); The more scores,the more severe; the two scales were evaluated separately.|three times: baseline, 10 weeks, 1 year|||units on a scale||Standard Deviation|Mean
688065|NCT01470859|Primary|Longitudinal Change of Brain Network Activity|"The brain network activity is evaluated by Parkinson's disease-related spatial covariance pattern(PDRP) value (Z score).
The change of brain network activity is calculated by the PDRP value (Z score) at V5 - the PDRP value (Z score) at V1."|twice, baseline and 1 year after baseline|||Z-score in PDRP||Standard Deviation|Mean
688066|NCT01470651|Secondary|Fatigue Severity Scale (FSS)|Fatigue Severity Scale is a 9-item scale measures the impact of fatigue on everyday functioning (e.g. “fatigue interferes with my work, family or social life”). Response format is a 7-point Likert scale of agreement with a 1-week time frame. Total score is the sum of item scores and ranges from 9 to 63 points, with higher scores indicating greater fatigue. A score greater than 40 is considered to be a clinically significant level of fatigue. Scores on the scale correlate highly with other measures of fatigue, is sensitive to change, and is routinely used in studies of modafinil/armodafinil.|Biweekly for the first month, monthly thereafter|||FSS score (out of 63)||Standard Deviation|Mean
688067|NCT01470651|Primary|Adherence to Medications Form|The Medication Adherence Form was designed to assess any HCV medication dosing changes, including discontinuation, and the reasons for the changes. The form asks specifically about the HCV medications: pegylated interferon, ribavirin and Incivek (or Victrelis), as well as the study medication, armodafinil.|HCV medication adherence reported at 12 weeks|Not all patients were given all medications, subjects are not factored in if they were not told to take a given drug.||Percentage of doses missed||Standard Error|Mean
688068|NCT01470469|Primary|Change From Baseline in ECG QTcF Interval at up to 12 Weeks|The QT interval is the time from the start of the Q wave to the end of the T wave. It is a portion of the ECG tracing that represents the time taken for ventricular depolarisation and repolarisation. The QTcF includes a correction factor to help account for changes in heart rate.|Baseline and up to 12 weeks|Safety Analysis Set consisted of all subjects who had taken at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||msec||Standard Deviation|Mean
688069|NCT01470469|Primary|Change From Baseline in Electrocardiogram (ECG) QRS Interval at up to 12 Weeks|QRS complex is a portion of the ECG tracing that represents depolarization of the ventricular myocardium.|Baseline and up to 12 weeks|Safety Analysis Set consisted of all subjects who had taken at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||msec||Standard Deviation|Mean
708919|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 12||Month 12|||L||Standard Error|Mean
688071|NCT01470469|Primary|Change From Baseline in Height at up to 12 Weeks||Baseline and up to 12 weeks|Safety Analysis Set consisted of all subjects who had taken at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||cm||Standard Deviation|Mean
688072|NCT01470469|Primary|Change From Baseline in Pulse Rate at Up to 12 Weeks||Baseline and up to 12 weeks|Safety Analysis Set consisted of all subjects who had taken at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||beats/min||Standard Deviation|Mean
688073|NCT01470469|Primary|Change From Baseline in Diastolic Blood Pressure at Up to 12 Weeks||Baseline and up to 12 weeks|Safety Analysis Set consisted of all subjects who had taken at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||mmHg||Standard Deviation|Mean
688074|NCT01470469|Primary|Change From Baseline in Systolic Blood Pressure at Up to 12 Weeks||Baseline and up to 12 weeks|Safety Analysis Set consisted of all subjects who had taken at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||mmHg||Standard Deviation|Mean
688075|NCT01470417|Secondary|Prognostic Risk Stratifiers|Evaluate key biochemical, radiographic, and pathologic factors that may impact response to neoadjuvant therapy|5 years||||||
688076|NCT01470417|Secondary|Quality of Life Analysis|Evaluate quality of life as related to treatment and toxicity.|2 years||||||
688077|NCT01470417|Secondary|Treatment Associated Toxicity|Evaluate treatment related acute and long-term toxicity|5 years||||||
688078|NCT01470417|Secondary|90 Day Post-operative Mortality|Evaluate mortality in the first 90 days after surgery|90 days after surgery|||participants|||Number
688079|NCT01470417|Secondary|Overall Survival|Survival status 5 years after treatment|5 years after treatment||||||
688080|NCT01470417|Secondary|Disease Free Survival|Length of disease free survival after treatment|5 years||||||
688081|NCT01470417|Primary|Pathologic Downstaging and Margin Status|Pathologic stage and margin status after resection. Pathologic downstaging was determined my looking at the rate of R0 (all residual tumor removed during surgery) vs R1 (microscopic tumor present at the resection margin per pathology) resections.|At the time of surgery after neoadjuvant therapy|Subjects who had a surgical resection of their primary tumor were included in this analysis.||participants|||Number
688082|NCT01470417|Primary|Radiographic Response Rate|Evaluate radiographic response of the measurable disease with repeat imaging at 4 - 8 weeks after therapy. Measurable disease was evaluated using Response Evaluation Criteria In Solid Tumors Criteria (RECIST) 1.1 criteria. Per RECIST v1.1 in target lesions assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD), >20% growth in the sum of the longest diameter or target lesions or appearance of new lesions; Stable Disease (SD), change in sum of longest diameter of target lesions does not meet criteria for PR or PD. The number of subjects experiencing Complete Response (CR), Partial Response (PR), Stable Disease (SD) and Progressive Disease (PD) is reported.|4 - 8 weeks after neoadjuvant therapy|All subjects enrolled in the study were included in this analysis.||participants|||Number
688083|NCT01470417|Primary|Biochemical Response Rate|Biochemical response rate (serum CA 19-9). Baseline compared to pre-operative serum CA19-9 values.|4 - 8 weeks after neoadjuvant therapy|The seven subjects included in this analysis had CA19-9 testing performed at baseline and again prior to surgery. Pre-operative CA19-9 testing was not performed for one subject so they were not included in this analysis nor were two subjects who were found to have progressive disease prior to completing neoadjuvant therapy.||U/mL||Full Range|Mean
688084|NCT01470248|Secondary|Overall Survival|Duration of time from enrollment on study until death|From enrolment till death on average up to 2 years|Two patients were not analyzed because only those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated were considered evaluable for response.||months||Full Range|Median
688085|NCT01470248|Secondary|Progression-free Survival|"Defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Progression was evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1).
Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm."|Every 8 weeks|Two patients were not analyzed because only those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated were considered evaluable for response.||weeks||Standard Deviation|Mean
688086|NCT01470248|Primary|Clinical Benefit Rate (CBR)|Sum of complete response (CR), partial response (PR) and stable disease (SD) in patients eligible for efficacy analysis.|After completing at least 1 cycle (8 weeks) of treatment|An alternative endpoint of clinical benefit rate was pre-specified in the event that the study failed to meet its overall response rate (ORR) endpoint either at the end of stage I accrual or at final analysis. However, this study met its endpoint. Please see primary outcome measure 1.|||||
688087|NCT01470248|Primary|Response Rate (RR)|"Response rate (complete response [CR]+ partial response [PR]) was evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1).
Complete response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.
Partial response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Progressive disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study."|Every 8 weeks|Two patients were not analyzed because only those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated were considered evaluable for response.||Participants|||Count of Participants
688120|NCT01469767|Primary|IGA|Investigator's Global Assessment of atopic dermatitis integrates all lesions for overall score. This measure is commonly used to quantify disease severity and most resembles assessments performed in the clinic setting. Score ranges from ‘0’ = Clear to ‘5’ = Very Severe Disease|14 days|||units on a scale||Full Range|Mean
688088|NCT01470196|Primary|Very Good Partial Response and Complete Response Rate|This is the rate of VGPR and CR in patients on CaRD therapy. Very good partial responses are >90% reduction in serum IgM from baseline. Complete response is defined as having resolution of all symptoms, normalization of serum IgM levels with complete disappearance of IgM paraprotein by immunofixation, and resolution of any adenopathy or splenomegaly.|4 years|||Participants|||Count of Participants
688089|NCT01470196|Primary|Major Response Rate|Major Response Rate= Partial Response (>50-90% reduction in serum IgM from baseline) + Very Good Partial Response (>90% reduction in serum IgM from baseline) + Complete Response (resolution of all symptoms, normalization of serum IgM with disappearance of IgM paraprotein, resolution of any adenopathy or splenomegaly).|4 years|||Participants|||Count of Participants
688090|NCT01470196|Primary|Time to Progression|Progression-free survival is the defined as the time from study entry to disease progression (PD) or death. Patients without PD are censored at the date of last disease evaluation. PD is defined as a greater than 25% increase in serum IgM and 500mg/dL absolute increase from the lowest attained response value as determined by serum electrophoresis, confirmed by at least one other investigation, or progression of clinically significant disease related symptom(s).|4 years|||months||95% Confidence Interval|Median
688091|NCT01470196|Primary|Neuropathy Incidence Rate|Number and percentage of participants who experienced neuropathy attributable to CaRD therapy|3 years|||Participants|||Count of Participants
688092|NCT01470196|Primary|Overall Response Rate|Overall Response Rate= Minor response (>25%-50% reduction in serum IgM from baseline + Partial Response (>50-90% reduction in serum IgM from baseline) + Very Good Partial Response (>90% reduction in serum IgM from baseline) + Complete Response (resolution of all symptoms, normalization of serum IgM with disappearance of IgM paraprotein, resolution of any adenopathy or splenomegaly).|4 years|||Participants|||Count of Participants
688093|NCT01470170|Secondary|Hypotension|Check the frequency of hypotension episode during induction, procedure and recovery time|All participants wil be follow for the duration of bronchoscope room stay, an expect average of 2 hours|||participants|||Number
688094|NCT01470170|Secondary|Hypoxemia|Check the frequency of hypoxemia episode during induction, procedure, and recovery time|All participants wil be follow for the duration of bronchoscope room stay, an expect average of 2 hours|||participants|||Number
688095|NCT01470170|Primary|Induction Time, Time Period That Will be Required for Conscious Level to Reach OAAS-3|After the administration of Alfentanil and Propofol, the time period required to reach conscious level OAAS-3 will be recorded.|All participants wil be follow for the duration of bronchoscope room stay, an expect average of 2 hours|||second||Standard Deviation|Mean
688096|NCT01470170|Primary|Propofol Dose Needed to Reach Conscious Level OAAS-3|After the administration of Alfentanil and Propofol, the Propofol dose needed to reach conscious level of observer assessment of alertness and sedation scale 3 (OAAS-3) will be recorded.|All participants wil be follow for the duration of bronchoscope room stay, an expect average of 2 hours|||mg||Standard Deviation|Mean
688097|NCT01470170|Primary|Effect Site Concentration When Conscious Level Reaches OAAS-3|After the administration of alfentanil and propofol, the effect site concentration was recorded at the time when the consciousness level reaches observer assessment of alertness and sedation scale 3 (OAAS-3). The effect site concentration is the concentration of drug propofol in brain calculated by TCI using Schnider model.|All participants wil be follow for the duration of bronchoscope room stay, an expect average of 2 hours|||ug/ml||Standard Deviation|Mean
688098|NCT01470144|Secondary|Exposure Duration|Duration of exposure to EFI|On average 2.72 years|||year||Full Range|Median
688099|NCT01470144|Primary|Treatment-emergent Adverse Events||On average 2.72 years|All patients who received at least one dose of EFI||Number of patients|||Number
688100|NCT01470118|Primary|Ocular Itching Evaluated by the Subject at 3, 5, and 7 Minutes Post Challenge on Day 14 at Hour 24|Ocular itching evaluated by the subject at 3, 5, and 7 minutes post challenge on Day 14 (Visit 4) at hour 24. Subjects scored their ocular itching on a numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less itching.|Day 14 Hour 24|Intent-to-Treat: All randomized subjects||Scores on a Scale||Standard Deviation|Mean
688101|NCT01470118|Secondary|Tearing Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24|Tearing evaluated by the subject at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Subjects scored tearing on a 5-point numeric analog scale ranging from 0=None/Normal to 4=Very Severe. For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less tearing.|Day 14 Hour 24|Intent-to-Treat: All randomized subjects||Scores on a Scale||Standard Deviation|Mean
688102|NCT01470118|Secondary|Eyelid Swelling Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24|Eyelid swelling evaluated by the subject at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Subjects scored eyelid swelling on a numeric analog 4-point scale ranging from 0=None to 3=Severe. For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less lid swelling.|Day 14 Hour 24|Intent-to-Treat: All randomized subjects||Scores on a Scale||Standard Deviation|Mean
688103|NCT01470118|Secondary|Chemosis Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24|Chemosis evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Investigators scored chemosis on a numeric analog scale ranging from 0=None to 4=Severe (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less chemosis.|Day 14 Hour 24|Intent-to-Treat: All randomized subjects||Scores on a Scale||Standard Deviation|Mean
688104|NCT01470118|Secondary|Episcleral Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24|Episcleral redness evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Investigators scored episcleral redness on a numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less episcleral redness.|Day 14 Hour 24|Intent-to-Treat: All randomized subjects||Scores on a Scale||Standard Deviation|Mean
688218|NCT01468337|Secondary|Changes in the Autofluorescence Patterns as Observed on Fundus Autofluorescence (FAF) Imaging at Week 2 Compared to Baseline||Baseline and Week 2||||||
688105|NCT01470118|Secondary|Ciliary Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24|Ciliary redness evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Investigators scored ciliary redness on a numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less ciliary redness.|Day 14 Hour 24|Intent-to-Treat: All randomized subjects||Scores on a Scale||Standard Deviation|Mean
688106|NCT01470118|Secondary|Conjunctival Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24|Conjunctival redness evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Investigators scored conjunctival redness on a numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less conjunctival redness.|Day 14 Hour 24|Intent-to-Treat: All randomized subjects||Scores on a Scale||Standard Deviation|Mean
688107|NCT01470118|Primary|Ocular Itching Evaluated by the Subject at 3, 5, and 7 Minutes Post Challenge on Day 0 at Hour 16|Ocular itching evaluated by the subject at 3, 5, and 7 minutes post challenge on Day 0 (Visit 3) at hour 16. Subjects scored their ocular itching on a numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less itching.|Day 0 Hour 16|Intent-to-Treat: All randomized subjects||Scores on a Scale||Standard Deviation|Mean
688108|NCT01470001|Secondary|Change in Patients Perspective of the Impact of Their Disease, Captured Using the Pelvic Floor Distress Inventory (Urinary Questions)|"The difference between baseline and follow up (last 20 days on drug) scores was the recorded measure. The larger the negative # the greater the effect.
The survey was divided into 3 sections, each section worth 100 points. Total scores could range from 0 to 300 (0 no disease, 300 severe disease)."|outcome measures will be assessed at week 0 (baseline), and compared to an average measure of the last 20 days on placebo or treatment|one subject was excluded from analysis because of missing baseline data||change in score||Full Range|Mean
688109|NCT01470001|Secondary|the Percent of Patients With at Least 50% Reduction in Post Void Dribbling Episodes||outcome measures will be assessed at week 0 (baseline), and compared to an average measure of weeks 10 through 12|one study subject was excluded form analysis due to missing baseline data||percent|||Number
688110|NCT01470001|Primary|The Percent Reduction in Post Void Dribbling Episodes (Events)||outcome measures will be assessed at week 0 (baseline), and compared to an average measure of weeks 10 through 12|one subject was excluded from analysis because of missing baseline data||percent reduction||Full Range|Mean
688111|NCT01469819|Secondary|Elimination of Small Intestine Bacterial Overgrowth (SIBO) in Chronically Constipated Patients Treated With Lubiprostone 24mcg Twice a Day for 2 Weeks.||Measured at baseline and 2 weeks after baseline.|||participants|||Number
688112|NCT01469819|Secondary|Changes in Number of Bowel Movements Per Week Changes GE, SB, LB and WG Transit Times Measured by SmartPill in Chronically Constipated Patients Treated for 2 Weeks With Lubiprostone 24mcg Twice a Day.||Measured at baseline and 2 weeks after baseline.|Number of Bowel Movements per week||number per week||Standard Error|Mean
688113|NCT01469819|Secondary|Changes in Time of GE, SB, LB and WG Transits Measured by SmartPill After 2 Weeks of Lubiprostone 24mcg BID in Chronically Constipated Patients.|Changes in Time of GE, SB, LB and WG transits measured by SmartPill after 2 weeks of lubiprostone 24mcg BID in chronically constipated patients who increased stool frequency to ≥ 2 times increase per week vs. patients who increased stool frequency < 2 times increase per week.|Measured at baseline and 2 weeks after baseline.|||Hours||Standard Error|Mean
688114|NCT01469819|Secondary|Changes in Number of Bowel Movements in Chronically Constipated Patients After 2 Weeks of Therapy With Lubiprostone 24mcg Twice a Day (BID).||Measured at baseline and 2 weeks after baseline|||number per week||Standard Error|Mean
688115|NCT01469819|Primary|Time Reduction (Hours and Minutes) of Gastric Emptying (GE), Small Bowel (SB), Large Bowel (LB) and Whole Gut (WG) Transits Measured by SmartPill in Chronically Constipated Patients Before and After 2 Weeks of Therapy With Lubiprostone 24mcg Twice a Day.|The change in transit time (TT), in hours and minutes, of gastric emptying (GE), small bowel (SB), large bowel (LB) and whole gut (WG) measured by SmartPill in 29 patients with chronic constipation after taking lubiprostone 24 micrograms twice a day (BID) for 2 weeks.|Measured at baseline and 2 weeks after baseline.|||Hours||Standard Error|Mean
688116|NCT01469767|Secondary|VAS|Visual Analog Scale for itch: A 100 millimeter (mm) Visual Analog Scale (VAS) will be used to measure itch intensity. VAS is a self-report tool that is designed to present to the respondent a rating scale with minimum constraints. VAS data is recorded as the number of mm from the left of the line with the range 0-100 mm. The Visual Analog Scale is anchored with the verbal descriptions of “no itch” on the left and “the most intense itch imaginable” on the right.|14 days|||units on a scale||Full Range|Mean
688117|NCT01469767|Secondary|BSA|Body Surface Area of atopic dermatitis. The BSA is measured as the total percent of the entire body with atopic dermatitis involved, so the scores range from 0% to 100% of total body involvement.|14 days|||Percent BSA||Full Range|Mean
688118|NCT01469767|Secondary|EASI|"Eczema Area and Severity Index Score:Disease severity will be assessed with the Eczema Area and Severity Index (EASI).This measure is commonly used and well validated instrument of eczema severity. It is weighted for area in each of the four body regions and scores erythema, excoriation, induration/papulation, and lichenification. The total are summed for one total EASI score. .The total scores range from 0 (no Eczema) -72 (most severe Eczema)."|14 days|||units on a scale||Full Range|Mean
688119|NCT01469767|Secondary|Actigraphy|Actigraphy Movement Count per Hour:Subjects will be asked to wear an actigraphy monitor on each wrist for the duration of the 14-day study. These monitors appear and function similarly to a wristwatch. The actigraph provides a continuous measure of wrist activity and may be used to quantify nocturnal scratching behavior. A piezoelectric accelerometer records the integration of intensity, amount, and duration of stimuli in all 3 dimensions of wrist movement. Measurements are taken at 32 Hz and a summation value is recorded at the end of each 30-second epoch. The number of 30-second epochs with movement (in which acceleration was detected irrespective of the magnitude of the acceleration) is recorded and summed to give a movement score. This is divided by the duration of time in bed to produce a movement count per hour, which is a sensitive quantitative measure of scratch-associated activity.|14 days|||Movement count per hour||Standard Deviation|Mean
688121|NCT01469715|Primary|Absolute Relative Difference (ARD)|"ARD=100*(G_sensor-G_reference)/G_reference
Calculated for when patient's G_ref was Normal (70-180 mg/dl), Hyperglycemic (>180 mg/dl) and Hypoglycemic (<70 mg/dl)
The study data includes 208 paired sensor-YSI plasma glucose readings (G_reference) for each GBP CGM sensor (G_sensor) inserted for 24 hours during hyperglycemic and hypoglycemic challenge conditions. Data pairs will permit the detailed evaluation of sensor performance parameters, including static accuracy metrics such as median and mean absolute deviations and median and mean absolute relative deviation and Point CG-EGA, as well as dynamic parameters, such as warm-up time, trend accuracy (Rate CG-EGA), and sensor lag."|25.5 hours|||percentage of error|||Number
688122|NCT01469637|Primary|Maximum Plasma Concentration at Steady-State (Cmaxss) for Sulfamethoxazole|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Assessed over a 24-hour period starting post-dose on day 4|Pharmacokinetic Analysis Set defined as all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Analysis Set defined as subjects who took at least 1 dose of investigational product and had at least 1 postdose safety assessment.||ug/ml||Standard Deviation|Mean
688123|NCT01469637|Primary|Area Under the Plasma Concentration Versus Time Curve Within a Dosing Interval at Steady-State (AUCss) for Sulfamethoxazole|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure of how much and how long a drug stays in a body.|Assessed over a 24-hour period starting post-dose on day 4|Pharmacokinetic Analysis Set defined as all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Analysis Set defined as subjects who took at least 1 dose of investigational product and had at least 1 postdose safety assessment.||h*ug/ml||Standard Deviation|Mean
688124|NCT01469546|Secondary|Median Progression-Free Survival (PFS)Time|To evaluate PFS time in patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (R/M SCCHN) treated with Axitinib.|6 months|42 patients were enrolled. 12 patients did not complete the first cycle or undergo repeat tumor imaging (due to adverse event, disease progression, non-compliance or physician discretion). Only 30 patients were analyzed.||months||95% Confidence Interval|Number
688125|NCT01469546|Secondary|Number of Patients That Experienced Grade 3 or 4 Toxicities|The number of patients who develop these while on treatment and for 28 days after cessation of axitinib, and graded in severity per CTCAE v. 3.0 and as described in the protocol. According to the CTCAE v. 3.0, grade 3 toxicities are severe and grade 4 toxicities are life-threatening or disabling.|28 Days Post Treatment|All patients that received at least one dose of treatment were analyzed for toxicity.||patients|||Number
688126|NCT01469546|Secondary|Number of Participants Who Achieved Complete Response, Partial Response or Stable Disease|"To determine the disease control rate (complete response+partial response+stable disease), in patients with unresectable recurrent and metastatic head and neck cancer treated with Axitinib.
Response Evaluation Criteria in Solid Tumors (RECIST version 1.0) will be used.
Complete Response is defined as the disappearance of all tumor for a period of one month.
Partial Response is defined as a 30% or more decrease in the sum of the longest diameters (LD) of all measured lesions without any evidence of progression of any lesion or the appearance of any new lesion for a period of one month.
Stable Disease is defined as any change in measurable disease which is less than the criteria for partial remission or progression without any evidence of new lesions and persisting for at least 2 evaluations or 2 months."|2 years|42 patients were enrolled. 12 patients did not complete the first cycle or undergo repeat tumor imaging (due to adverse event, disease progression, non-compliance or physician discretion). Only 30 patients were analyzed.||participants|||Number
688127|NCT01469546|Primary|Percentage of Patients Alive and Free of Progression at 6 Months|To determine the 6-months progression-free survival (PFS) rate in patients with unresectable recurrent and metastatic head and neck cancer treated with Axitinib.|6 months|42 patients were enrolled. 12 patients did not complete the first cycle or undergo repeat tumor imaging (due to adverse event, disease progression, non-compliance or physician discretion). Only 30 patients were analyzed.||percentage of patients|||Number
688128|NCT01469364|Primary|Change in Pulmonary Function, as Measured by Serial Forced Expiratory Flow (FEF25-75) on Spirometry at Baseline (Prior to AZLI First Dose) and During AZLI Therapy at Month 1|Within-subject change to absolute FEF 25-75 month 1 vs. 0. FEF 25-75 was measured 14-35 days after the start of months 1|Baseline, month 1|||Liter||Inter-Quartile Range|Median
688129|NCT01469364|Primary|Change in Pulmonary Function, as Measured by Serial Forced Expiratory Flow (FEF25-75) on Spirometry at Baseline (Prior to AZLI First Dose) and During AZLI Therapy at Month 5.|Within-subject change to absolute FEF 25-75 month 5 vs 0. FEF 25-75 was measured 14-35 days after the start of months 5|Baseline, month 5|||Liter||Inter-Quartile Range|Median
688130|NCT01469364|Primary|Change in Respiratory-specific Health Related Quality of Life, Measured by Serially Self Administered St. George's Respiratory Questionnaire (SGRQ) at Baseline (Prior to AZLI First Dose) and During AZLI Therapy at Month 5.|The SRGQ measures activities, symptoms, and impacts of living with a pulmonary condition. We analyzed the change to the within-subject Total score month 5 vs 0. Total score ranges from 0-100 with a smaller value representing better respiratory-specific QOL. A change in score of 4 points or more is considered clinically meaningful. Scores represent Median Absolute Difference in theTotal Score. The SGRQ was completed 14-35 days after the start of month 5 AZLI courses and compared to study month 0 (baseline/prior to 1st dose).|Baseline, month 5|subjects with completed SF-36 surveys at month 5 and 0 (n=26) time-points.||units on a scale||Inter-Quartile Range|Median
688131|NCT01469364|Primary|Change in Respiratory-specific Health Related Quality of Life, Measured by Serially Self Administered St. George's Respiratory Questionnaire (SGRQ) at Baseline (Prior to AZLI First Dose) and During AZLI Therapy at Month 1|The SRGQ measures activities, symptoms, and impacts of living with a pulmonary condition. We analyzed the change to the within-subject Total score month 1 vs. 0. Total score ranges from 0-100 with a smaller value representing better respiratory-specific QOL. A change in score of 4 points or more is considered clinically meaningful. Scores represent Median Absolute Difference in the Total Score. The SGRQ was completed 14-35 days after the start of months 1 AZLI courses and compared to study month 0 (baseline/prior to 1st dose).|Baseline, month 1|subjects with completed SF-36 surveys at month 1 and month 0 (n=28) time-points.||units on a scale||Inter-Quartile Range|Median
688219|NCT01468337|Secondary|Changes in Leakage as Observed on Fluorescein Angiography (FA) at Week 2 Compared to Baseline||Baseline and Week 2||||||
710428|NCT00161382|Secondary|Self-efficacy||Measured throughout the study||||||
688132|NCT01469364|Primary|Change in Global Health Related Quality of Life, Measured by Serially Self-administered Short Form 36 Health Survey Questionnaire (SF-36) at Baseline (Prior to AZLI First Dose) and During AZLI Therapy at Month 1 and Month 5.|The SF-36 is a commonly used, well validated measure of global health related quality of life. The survey was self-administered. There are 8 subscales which combine to form a Physical Component Score (PCS) and a Mental Component Score (MCS). We analyzed within subject changes to the PCS and MCS at month 5 vs 0. MCS and PCS scores are relative to a US population mean of 50. The higher the score, the better one perceives his quality of life. A change in score of 4 points or more is considered clinically meaningful. Scores represent Median Absolute Difference. The SF-36 was completed 14-35 days after the start of months 1 and 5 AZLI courses and compared to study month 0 (baseline/prior to 1st dose).|Baseline, month 5|subjects with completed SF-36 surveys at month 5 and 0 (n=26) time-points.||units on a scale||Inter-Quartile Range|Median
688133|NCT01469364|Primary|Change in Global Health Related Quality of Life, Measured by Serially Self-administered Short Form 36 Health Survey Questionnaire (SF-36) at Baseline (Prior to AZLI First Dose) and During AZLI Therapy at Month 1|The SF-36 is a commonly used, well validated measure of global health related quality of life. The survey was self-administered. There are 8 subscales which combine to form a Physical Component Score (PCS) and a Mental Component Score (MCS). We analyzed within subject changes to the PCS and MCS at month 1 vs. 0. MCS and PCS scores are relative to a US population mean of 50. The higher the score, the better one perceives his quality of life. A change in score of 4 points or more is considered clinically meaningful. Scores represent Median Absolute Difference. The SF-36 was completed 14-35 days after the start of months 1 AZLI courses and compared to study month 0 (baseline/prior to 1st dose).|Baseline, month 1|subjects with completed SF-36 surveys at month 1 and month 0 (n=28)||units on a scale||Inter-Quartile Range|Median
688134|NCT01469364|Secondary|Bronchoalveolar Lavage Fluid (BALF) Neutrophilia After Treatment, When Performed as Part of Clinical Care (SOC).|The study team is measuring the change in neutrophils AFTER treatment. They will compare a SOC BAL taken after AZLI with the BAL taken within 90 days of AZLI initiation (pre or baseline measure). The post AZLI BAL measurement time range is 15 days after first course of AZLI up to last day of the 3rd and final course of AZLI (over a period of 5 consecutive months).|Baseline - defined as a within 90 days of enrollment and After Treatment (5 months)|Participants with paired SOC bronchoalveolar lavage fluid cell differential counts performed within 90 days of AZLI month 1 (baseline timepoint) and >=15 days after AZLI dose 1 through the completion of dose 3 (study month 5) were included in the analysis (n=5).||mean percentage of neutrophils||Standard Deviation|Mean
688135|NCT01469364|Secondary|Among Patients Colonized With Pseudomonas Aeruginosa, Change in Infection Burden as Measured by the Culture Final Report (0,1+, 2+, 3+, 4+) of in Pseudomonas Aeruginosa Sputum or Bronchoalveolar Fluid.|Microbiology data was collected when performed for SOC purposes on BAL or sputum samples. Baseline and 1 month value represents the culture final report value (0,1+, 2+, 3+, 4+) of Pseudomonas aeruginosa. A value of zero represents no Pseudomonas aeruginosa sputum or bronchoalveolar fluid. A value of 4 represents high amounts of Pseudomonas aeruginosa sputum or bronchoalveolar fluid.|Baseline, month 1|The statistical analysis was unable to be performed due to insufficient number of paired observations. Only 9 of 30 enrolled had baseline microbiology data, 3 were cultured positive for Pseudomonas Aeruginosa. Only 1 of the 3 had a subsequent SOC BAL sample collected. Therefore, only raw data is entered for the one subject.||culture value of Pseudomonas aeruginosa|||Number
688136|NCT01469364|Secondary|Change in HRQOL Off AZLI Therapy.|This will be compared to study month 0 (baseline), when obtained at standard of care visit (SOC)|At study months 2 or 4|Partial data for this outcome measure was collected on 4 participants and due to not having a complete data set the analyzation was not completed.|||||
688137|NCT01469364|Secondary|Change in FEV1 Off AZLI Therapy|This will be compared to study month 0 (baseline, when obtained as standard of care (SOC).|At Study Months 2 and 4|Partial data for this outcome measure was collected on 4 participants and due to not having complete data set analyzation was not completed.|||||
688138|NCT01469364|Primary|Change in Pulmonary Function, as Measured by Serial Forced Expiratory Volume in 1 Second (FEV1) on Spirometry|Within-subject change to absolute FEV1 month 5 vs 0.|Baseline, month 5|||Liter||Inter-Quartile Range|Median
688139|NCT01469364|Primary|Change in Pulmonary Function, as Measured by Serial Forced Expiratory Volume in 1 Second (FEV1) on Spirometry|Within-subject change to absolute FEV1 month 1 vs. 0. FEV1 was measured 14-35 days after the start of months 1 AZLI courses and compared to study month 0 (baseline/prior to 1st dose).|Baseline, month 1|||Liter||Inter-Quartile Range|Median
688140|NCT01469234|Secondary|Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point|"The individual symptom score for Itchy Mouth/Throat/Ears was rated on a 5-point
scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Itchy Mouth/Throat/Ears symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity."|From time of sensitization (time 0) to end of visit (~8 hours)|"Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available.
N=Number of Participants Analyzed, n=number of participants with data available at the given time point."||units on a scale||Standard Deviation|Mean
688141|NCT01469234|Secondary|Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point|"The individual symptom score for Nasal Congestion was rated on a 5-point
scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Nasal Congestion symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity."|From time of sensitization (time 0) to end of visit (~8 hours)|"Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available.
N=Number of Participants Analyzed, n=number of participants with data available at the given time point."||units on a scale||Standard Deviation|Mean
708920|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 12||Month 12|||L||Standard Error|Mean
688142|NCT01469234|Secondary|Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point|"The individual symptom score for Itchy Eyes was rated on a 5-point
scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Itchy Eyes symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity."|From time of sensitization (time 0) to end of visit (~8 hours)|"Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available.
N=Number of Participants Analyzed, n=number of participants with data available at the given time point."||units on a scale||Standard Deviation|Mean
688143|NCT01469234|Secondary|Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point|"The individual symptom score for Water Eyes was rated on a 5-point
scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Watery Eyes symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity."|From time of sensitization (time 0) to end of visit (~8 hours)|"Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available.
N=Number of Participants Analyzed, n=number of participants with data available at the given time point."||units on a scale||Standard Deviation|Mean
688144|NCT01469234|Secondary|Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point|"The individual symptom score for Sneezing was rated on a 5-point
scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Sneezing symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity."|From time of sensitization (time 0) to end of visit (~8 hours)|"Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available.
N=Number of Participants Analyzed, n=number of participants with data available at the given time point."||units on a scale||Standard Deviation|Mean
688145|NCT01469234|Secondary|Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point|"The individual symptom score for Itchy Nose was rated on a 5-point
scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Itchy Nose symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity."|From time of sensitization (time 0) to end of visit (~8 hours)|"Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available.
N=Number of Participants Analyzed, n=number of participants with data available at the given time point."||units on a scale||Standard Deviation|Mean
688146|NCT01469234|Secondary|Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point|"The individual symptom score for Runny Nose was rated on a 5-point
scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Runny Nose symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity."|From time of sensitization (time 0) to end of visit (~8 hours)|"Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available.
N=Number of Participants Analyzed, n=number of participants with data available at the given time point."||units on a scale||Standard Deviation|Mean
688147|NCT01469234|Primary|Mean Major Symptom Complex (MSC) Score by Post-Treatment Evaluation Time Point (From 180 Minutes to 300 Minutes)|The MSC Score is calculated as the sum of 5 individual symptom scores for Runny Nose, Itchy Nose, Sneezing, Watery Eyes, and Itchy Eyes. Each individual symptom is rated on a 5-point scale of severity: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The total MSC score ranges from 0 - 25. Increasing scores are associated with increasing severity.|From time of sensitization (time 0) to end of visit (~8 hours)|"Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available.
N=Number of Participants Analyzed, n=number of participants with data available at the given time point."||units on a scale||Standard Deviation|Mean
688148|NCT01469182|Secondary|Number of Participants Who Discontinued Due to Treatment-emergent AEs|Participants were treated with either SCH 39641 12 Amb a 1-U or placebo for 28 days, and the number who discontinued due to treatment emergent-AEs were recorded. An AE is any unfavorable and unintended sign, symptom or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment-emergent AEs are new AEs that occur after participants have been randomized into the trial, or existing AEs that occurred during Screening that increase in severity after randomization.|Up to Day 28|ASAT consisting of participants who received at least one dose of study treatment||Participants|||Number
688149|NCT01469182|Secondary|Number of Participants Reporting Skin Pruritus|Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with skin pruritus were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported.|Up to Day 35|ASAT consisting of participants who received at least one dose of study treatment||Participants|||Number
688150|NCT01469182|Secondary|Number of Participants Reporting Nasal Passage Irritation|Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with nasal passage irritation were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported.|Up to Day 35|ASAT consisting of participants who received at least one dose of study treatment||Participants|||Number
688151|NCT01469182|Secondary|Number of Participants Reporting Eye Pruritus|Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with eye pruritus were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported.|Up to Day 35|ASAT consisting of participants who received at least one dose of study treatment||Participants|||Number
688152|NCT01469182|Secondary|Number of Participants Reporting Mouth Oedema|Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with mouth oedema were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported.|Up to Day 35|ASAT consisting of participants who received at least one dose of study treatment||Participants|||Number
688153|NCT01469182|Secondary|Number of Participants Reporting Throat Irritation|Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with throat irritation were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported.|Up to Day 35|ASAT consisting of participants who received at least one dose of study treatment||Participants|||Number
688154|NCT01469182|Secondary|Number of Participants Reporting Ear Pruritus|Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with ear pruritus were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported.|Up to Day 35|ASAT consisting of participants who received at least one dose of study treatment||Participants|||Number
688155|NCT01469182|Secondary|Number of Participants Reporting Oral Pruritus.|Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with oral pruritus were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported.|Up to Day 35|ASAT consisting of participants who received at least one dose of study treatment||Participants|||Number
688156|NCT01469182|Primary|Number of Participants With Treatment-emergent Adverse Events (AEs)|Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with treatment-emergent AEs were recorded. An AE is any unfavorable and unintended sign, symptom or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment-emergent AEs are new AEs that occur after participants have been randomized into the trial, or existing AEs that occurred during Screening that increase in severity after randomization.|Up to Day 35|All subjects as treated (ASAT) consisting of participants who received at least one dose of study treatment||Participants|||Number
688157|NCT01469065|Secondary|Change From Baseline in Fasting Lipid Parameters at Day 14 and 16|Baseline for fasting triglycerides (TG) was defined as the average of the Day -1 (hour -48), Day 0 (hour -24), and Day 1 pre-dose (hour 0) measurements. Baseline for fasting total cholesterol (TC), cholesterol (high-density lipoprotein (HDL)), and cholesterol (low-density lipoprotein (LDL)) was defined as the Day 1 pre-dose (hour 0) measurement.|Baseline: hour -48 on Day -1, hour -24 on Day 0, and hour 0 on Day 1 for TG and Hour 0 (before morning dose) on Day 1 for TC, HDL, and LDL; 48 hours after morning dose on Day 16 for TG and Hour 0 (before morning dose) on Day14 for TC, HDL, and LDL|"The pharmacodynamic analysis population was defined as all randomized participants who received at least 1 dose of study medication (PF-04991532 or placebo) and had at least 1 of the pharmacodynamic parameters of interest; n is the number of participants analyzed for each day."||mg/dL||Standard Deviation|Mean
688158|NCT01469065|Secondary|Change From Baseline in Area Under the Curve of C-peptide From Time 2 to 6 Hours Post Morning Dose (C-peptide AUC(2-6)) Following Mixed Meal Tolerance Test (MMTT) at Day 14|Area Under the Curve of C-peptide from Time 2 to 6 Hours Post Morning Dose (C-peptide AUC(2-6)) was calculated based on 8 C-peptide measurements at prespecified timepoints using the linear trapezoidal method. Nominal times were used in the calculation. Liquid meal was administered 2 hours post morning dose of PF-04991532 for mixed meal tolerance test (MMTT).|Baseline: hours -46, -45.75, -45.5, -45, -44.5, -44, -43, -and -42 on Day -1 (Day 1 morning dose was hour 0); Day 14: 2, 2.25, 2.5, 3, 3.5, 4, 5, and 6 hours after Day 14 morning dose|The pharmacodynamic analysis population was defined as all randomized participants who received at least 1 dose of study medication (PF-04991532 or placebo) and had at least 1 of the pharmacodynamic parameters of interest.||ng*hr/mL||Standard Deviation|Mean
688159|NCT01469065|Secondary|Change From Baseline in Area Under the Curve of Insulin From Time 2 to 6 Hours Post Morning Dose (Insulin AUC(2-6)) Following Mixed Meal Tolerance Test (MMTT) at Day 14|Area Under the Curve of Insulin from Time 2 to 6 Hours Post Morning Dose (Insulin AUC(2-6)) was calculated based on 8 insulin measurements at prespecified time points using the linear trapezoidal method. Nominal times were used in the calculation. Liquid meal was administered 2 hours post morning dose of PF-04991532 for mixed meal tolerance test (MMTT).|Baseline: hours -46, -45.75, -45.5, -45, -44.5, -44, -43, -and -42 on Day -1 (Day 1 morning dose was hour 0); Day 14: 2, 2.25, 2.5, 3, 3.5, 4, 5, and 6 hours after Day 14 morning dose|The pharmacodynamic analysis population was defined as all randomized participants who received at least 1 dose of study medication (PF-04991532 or placebo) and had at least 1 of the pharmacodynamic parameters of interest.||milliUnit*hour/liter (mU*hr/L)||Standard Deviation|Mean
688160|NCT01469065|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|The average of the Day -1 (hour -48), Day 0 (hour -24) and Day 1 pre-dose (hour 0) measurements was the baseline for fasting plasma glucose (FPG) analyses.|Baseline: hour -48 on Day -1, hour -24 on Day 0, and hour 0 (before morning dose) on Day 1; hour 0 (before morning dose of each day) on Days 1, 2, 3, 6, and 10; and 24 hours after Day 14 morning dose on Day 15|"The pharmacodynamic analysis population was defined as all randomized participants who received at least 1 dose of study medication (PF-04991532 or placebo) and had at least 1 of the pharmacodynamic parameters of interest; n is the number of participants analyzed for each day."||mg/dL||Standard Deviation|Mean
688173|NCT01469065|Secondary|Area Under the Curve From Time Zero to 10 Hours Postdose (AUC10) of PF-04991532|Area under the plasma concentration versus time curve (AUC) from time zero to 10 hours post morning dose.|0 (before morning dose), 0.5, 1, 2, 3, 4, 6, and 10 hours after morning dose on Day 1 and Day 14|"The pharmacokinetic parameter analysis population was defined as all randomized participants treated with PF-04991532 who had at least 1 of the pharmacokinetic parameters of interest; n is the number of participants analyzed for each day."||ng*hr/mL||Standard Deviation|Geometric Mean
688161|NCT01469065|Secondary|Change From Baseline in Area Under the Curve of Glucose From Time 2 to 6 Hours Post Morning Dose (Glucose AUC(2-6)) Following Mixed Meal Tolerance Test (MMTT) at Day 14|Area under the curve of glucose from time 2 to 6 hours post morning dose (Glucose AUC(2-6)) was calculated based on 8 glucose measurements at prespecified time points using the linear trapezoidal method. Nominal times were used in the calculation. Liquid meal was administered 2 hours post morning dose of PF-04991532 for mixed meal tolerance test (MMTT).|Baseline: hours -46, -45.75, -45.5, -45, -44.5, -44, -43, -and -42 on Day -1 (Day 1 morning dose was hour 0); Day 14: 2, 2.25, 2.5, 3, 3.5, 4, 5, and 6 hours after Day 14 morning dose|The pharmacodynamic analysis population was defined as all randomized participants who received at least 1 dose of study medication (PF-04991532 or placebo) and had at least 1 of the pharmacodynamic parameters of interest.||mg*hr/dL||Standard Deviation|Mean
688162|NCT01469065|Secondary|Change From Baseline (Day -2) in Mean Daily Glucose at Day 13|Mean daily glucose (MDG) was calculated based on the mean of 8 glucose measurements at pre-specified time points throughout the day.|Baseline: hours -72, -70, -68, -66, -62, -60, -57, and -54 on Day -2 (Day 1 morning dose was hour 0); Day 13: 0 (before morning dose), 2, 4, 6, 10, 12, 15 and 18 hours after Day 13 morning dose|The pharmacodynamic analysis population was defined as all randomized participants who received at least 1 dose of study medication (PF-04991532 or placebo) and had at least 1 of the pharmacodynamic parameters of interest.||mg/dL||Standard Deviation|Mean
688163|NCT01469065|Secondary|Dose Normalized Maximum Plasma Concentration After Morning Dose Administration (Cmax(AM)(dn)) of PF-04991532|Maximum Observed Plasma Concentration of PF-04991532 after Morning Dose Administration (Cmax(AM)) divided by dose|0 (before morning dose), 0.5, 1, 2, 3, 4, 6, and 10 hours after morning dose on Day 1 and Day 14|"The pharmacokinetic parameter analysis population was defined as all randomized participants treated with PF-04991532 who had at least 1 of the pharmacokinetic parameters of interest; n is the number of participants analyzed for each day."||ng/mL/mg||Standard Deviation|Geometric Mean
688164|NCT01469065|Secondary|Dose Normalized Area Under the Curve From Time Zero to 24 Hours Postdose (AUC24(dn)) of PF-04991532|Area under the curve from time zero to 24 Hours Postdose (AUC24) divided by total daily dose|0 (before morning dose), 0.5, 1, 2, 3, 4, 6, 10, 10.5, 11, 12, 13, 15, 18, and 24 hours after morning dose on Day 1 and Day 14|"The pharmacokinetic parameter analysis population was defined as all randomized participants treated with PF-04991532 who had at least 1 of the pharmacokinetic parameters of interest; n is the number of participants analyzed for each day."||ng*hr/mL/mg||Standard Deviation|Geometric Mean
688165|NCT01469065|Secondary|Observed Accumulation Ratio of Maximum Observed Plasma Concentration of PF-04991532 After Morning Dose Administration (Rac, Cmax(AM))|Maximum observed plasma concentration of PF-04991532 after morning dose administration (Cmax(AM)) of Day 14 divided by Cmax(AM) of Day 1|0 (before morning dose), 0.5, 1, 2, 3, 4, 6, and 10 hours after morning dose on Day 1 and Day 14|The pharmacokinetic parameter analysis population was defined as all randomized participants treated with PF-04991532 who had at least 1 of the pharmacokinetic parameters of interest.||ratio||Standard Deviation|Geometric Mean
688166|NCT01469065|Secondary|Observed Accumulation Ratio of Area Under the Curve From Time Zero to 10 Hours Postdose of PF-04991532 (Rac)|Area under the curve from time zero to 10 hours postdose of PF-04991532 (AUC10) of Day 14 divided by AUC10 of Day 1|0 (before morning dose), 0.5, 1, 2, 3, 4, 6, and 10 hours after morning dose on Day 1 and Day 14|The pharmacokinetic parameter analysis population was defined as all randomized participants treated with PF-04991532 who had at least 1 of the pharmacokinetic parameters of interest.||ratio||Standard Deviation|Geometric Mean
688167|NCT01469065|Secondary|Apparent Oral Clearance (CL/F) of PF-04991532|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Day 1 and Day 14: 0 (before morning dose), 0.5, 1, 2, 3, 4, 6, 10 (before evening dose), 10.5, 11, 12, 13, 15, 18 and 24 hours after morning dose|"The pharmacokinetic parameter analysis population was defined as all randomized participants treated with PF-04991532 who had at least 1 of the pharmacokinetic parameters of interest; n is the number of participants analyzed for each day."||milliliter/minute (mL/min)||Standard Deviation|Geometric Mean
688168|NCT01469065|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04991532 After Evening Dose Administration (Tmax(PM))|Time was computed as post morning dose.|10 (before evening dose), 10.5, 11, 12, 13, 15, 18, and 24 hours after morning dose on Day 1 and Day 14|"The pharmacokinetic parameter analysis population was defined as all randomized participants treated with PF-04991532 who had at least 1 of the pharmacokinetic parameters of interest; n is the number of participants analyzed for each day."||hour||Full Range|Median
688169|NCT01469065|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04991532 After Morning Dose Administration (Tmax(AM))||0 (predose), 0.5, 1, 2, 3, 4, 6, and 10 hours after morning dose on Day 1 and Day 14|"The pharmacokinetic parameter analysis population was defined as all randomized participants treated with PF-04991532 who had at least 1 of the pharmacokinetic parameters of interest; n is the number of participants analyzed for each day."||hour||Full Range|Median
688170|NCT01469065|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) of PF-04991532||Day 14|The pharmacokinetic parameter analysis population was defined as all randomized participants treated with PF-04991532 who had at least 1 of the pharmacokinetic parameters of interest.||ng/mL||Standard Deviation|Geometric Mean
688171|NCT01469065|Secondary|Maximum Observed Plasma Concentration of PF-04991532 After Evening Dose Administration (Cmax(PM))||10 (before evening dose), 10.5, 11, 12, 13, 15, 18, and 24 hours after morning dose on Day 1 and Day 14|"The pharmacokinetic parameter analysis population was defined as all randomized participants treated with PF-04991532 who had at least 1 of the pharmacokinetic parameters of interest; n is the number of participants analyzed for each day."||ng/mL||Standard Deviation|Geometric Mean
688172|NCT01469065|Secondary|Maximum Observed Plasma Concentration of PF-04991532 After Morning Dose Administration (Cmax(AM))||0 (before morning dose), 0.5, 1, 2, 3, 4, 6, and 10 hours after morning|||ng/mL||Standard Deviation|Geometric Mean
688212|NCT01468337|Secondary|Changes in Mean Macular Sensitivity as Assessed by Microperimetry at Week 48 Compared to Baseline||Baseline and Week 48||||||
688213|NCT01468337|Secondary|Changes in the Autofluorescence Patterns as Observed on Fundus Autofluorescence (FAF) Imaging at Week 48 Compared to Baseline||Baseline and Week 48||||||
688174|NCT01469065|Secondary|Area Under the Curve From Time Zero to 24 Hours Postdose (AUC24) of PF-04991532|Area under the plasma concentration versus time curve (AUC) from time zero to 24 hours post morning dose|0 (before morning dose), 0.5, 1, 2, 3, 4, 6, 10, 10.5, 11, 12, 13, 15, 18, and 24 hours after morning dose on Day 1 and Day 14|"The pharmacokinetic parameter analysis population was defined as all randomized participants treated with PF-04991532 who had at least 1 of the pharmacokinetic parameters of interest; n is the number of participants analyzed for each day."||nanogram*hour/milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
688175|NCT01469065|Primary|Change From Baseline (Day -1) in Mean Daily Glucose at Day 14|Mean daily glucose (MDG) was calculated based on the mean of 8 glucose measurements at pre-specified time points throughout the day on Day -1 and Day 14.|Baseline: hours -46, -44, -42, -40, -38, -36, -33, -and -30 on Day -1 (Day 1 morning dose was hour 0); Day 14: 2, 4, 6, 8, 10, 12, 15, and 18 hours after Day 14 morning dose|The pharmacodynamic analysis population was defined as all randomized participants who received at least 1 dose of study medication (PF-04991532 or placebo) and had at least 1 of the pharmacodynamic parameters of interest.||milligram/deciliter (mg/dL)||Standard Deviation|Mean
688176|NCT01469052|Secondary|Plasma Decay Half-Life (t1/2) in Fed State Versus Overnight Fasting|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 29 (Day 1 of Cycle 2) and Day 30 (Day 2 of Cycle 2)|The actual mean values were not reported in the fed and fasted state because the food effect evaluation was conducted across different dose groups and hence it was not appropriate to report overall mean values in different doses as PK parameters change with dose.||hr||90% Confidence Interval|Geometric Mean
688177|NCT01469052|Secondary|Apparent Oral Clearance (CL/F) in Fed State Versus Overnight Fasting|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 29 (Day 1 of Cycle 2) and Day 30 (Day 2 of Cycle 2)|The actual mean values were not reported in the fed and fasted state because the food effect evaluation was conducted across different dose groups and hence it was not appropriate to report overall mean values in different doses as PK parameters change with dose.||L/hr||90% Confidence Interval|Geometric Mean
688178|NCT01469052|Secondary|Area Under the Curve From Time Zero to 24 Hours [AUC (0-24)] in Fed State Versus Overnight Fasting|AUC (0-24)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-24).|Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 29 (Day 1 of Cycle 2) and Day 30 (Day 2 of Cycle 2)|The actual mean values were not reported in the fed and fasted state because the food effect evaluation was conducted across different dose groups and hence it was not appropriate to report overall mean values in different doses as PK parameters change with dose.||ng*hr/mL||90% Confidence Interval|Geometric Mean
688179|NCT01469052|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) in Fed State Versus Overnight Fasting||Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 29 (Day 1 of Cycle 2) and Day 30 (Day 2 of Cycle 2)|The actual mean values were not reported in the fed and fasted state because the food effect evaluation was conducted across different dose groups and hence it was not appropriate to report overall mean values in different doses as PK parameters change with dose.||hr||90% Confidence Interval|Mean
688180|NCT01469052|Secondary|Maximum Observed Plasma Concentration (Cmax) in Fed State Versus Overnight Fasting||Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 29 (Day 1 of Cycle 2) and Day 30 (Day 2 of Cycle 2)|The actual mean values were not reported in the fed and fasted state because the food effect evaluation was conducted across different dose groups and hence it was not appropriate to report overall mean values in different doses as PK parameters change with dose.||ng/mL||90% Confidence Interval|Geometric Mean
688181|NCT01469052|Secondary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 1 and 15 of Cycle 1 and Day 29 (Day 1 of Cycle 2); pre-dose on Day 43 (Day 15 of Cycle 2) and Day 57 (Day 1 of Cycle 3)|Analysis population included all enrolled participants who received at least one dose of the study drug. ‘n’ signifies those participants evaluated for this measure at specific time point for each cohort respectively.||hr||Standard Deviation|Mean
688182|NCT01469052|Secondary|Apparent Oral Clearance (CL/F)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 1 and 15 of Cycle 1 and Day 29 (Day 1 of Cycle 2); pre-dose on Day 43 (Day 15 of Cycle 2) and Day 57 (Day 1 of Cycle 3)|Analysis population included all enrolled participants who received at least one dose of the study drug. ‘n’ signifies those participants evaluated for this measure at specific time point for each cohort respectively.||Liter/hr (L/hr)||95% Confidence Interval|Geometric Mean
688183|NCT01469052|Secondary|Area Under the Curve From Time Zero to 12 Hours [AUC (0-12)]|AUC (0-12)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-12).|Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 1 and 15 of Cycle 1 and Day 29 (Day 1 of Cycle 2); pre-dose on Day 43 (Day 15 of Cycle 2) and Day 57 (Day 1 of Cycle 3)|Analysis population included all enrolled participants who received at least one dose of the study drug. ‘n’ signifies those participants evaluated for this measure at specific time point for each cohort respectively.||ng*hr/mL||95% Confidence Interval|Geometric Mean
688184|NCT01469052|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 1 and 15 of Cycle 1 and Day 29 (Day 1 of Cycle 2); pre-dose on Day 43 (Day 15 of Cycle 2) and Day 57 (Day 1 of Cycle 3)|Analysis population included all enrolled participants who received at least one dose of the study drug. ‘n’ signifies those participants evaluated for this measure at specific time point for each cohort respectively.||hr||Full Range|Median
688214|NCT01468337|Secondary|Changes in Leakage as Observed on Fluorescein Angiography (FA) at Week 48 Compared to Baseline||Baseline and Week 48||||||
688215|NCT01468337|Secondary|Changes in Central Retinal Thickness as Measured on Optical Coherence Tomography (OCT) at Week 48 Compared to Baseline||Baseline and Week 48||||||
710429|NCT00161382|Secondary|Knowledge||Measured throughout the study||||||
688185|NCT01469052|Secondary|Maximum Observed Plasma Concentration (Cmax)||Pre-dose, 0.5, 1, 2, 4, 8, and 12 hours (hrs) post-dose on Day (D) 1 and 15 of Cycle (C) 1 and Day 29 (Day 1 of Cycle 2); pre-dose on Day 43 (Day 15 of Cycle 2) and Day 57 (Day 1 of Cycle 3)|Analysis population included all enrolled participants who received at least one dose of the study drug.‘n’ signifies those participants evaluated for this measure at specific time point for each cohort respectively.||Nanogram/milliliter (ng/mL)||Standard Deviation|Geometric Mean
688186|NCT01469052|Primary|Maximum Tolerated Dose (MTD)|"MTD is defined as the dose level at which no more than 1 of 6 participants experience dose-limiting toxicity (DLT) following de-escalation from the maximum administered dose (MAD). DLT includes grade (Gr) 2 or greater gastrointestinal toxicities, Gr 3 anemia, nonhematological toxicities (excluding nausea, vomiting, and diarrhea) or Gr 4 neutropenia, thrombocytopenia and inability to resume axitinib (AG-013736) dosing within 14 days of stopping due to treatment related toxicity."|Baseline up to Day 28|Analysis population included all enrolled participants who received at least one dose of the study drug.||mg BID|||Number
688187|NCT01469039|Secondary|Clinical Global Impression - Improvement (CGI-I) Scores at Day 85|"The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the study. Results indicate participants evaluated at one of the following categories: 1: very much improved; 2: much improved; 3: minimally improved; 4: no change; 5: minimally worse; 6: much worse; or 7: very much worse."|85 Days|FAS, defined as all randomized subjects who received at least 1 IM dose of study drug and had at least 1 primary efficacy assessment after administration of IM study drug.||participants in category|||Number
688188|NCT01469039|Primary|The Change From Baseline at Day 85 in Positive and Negative Syndrome Scale (PANSS) Total Score|The PANSS scale contains 30 questions, each containing an answer range of 1-7. A total PANSS score can range from between 30 to 210; a higher score indicates a worse disease condition.|Data collected from baseline to day 85|Full Analysis Set (FAS) defined as all randomized subjects who received at least 1 dose of IM study drug and had at least 1 primary efficacy assessment after administration of IM study drug.||units on a scale||Standard Error|Least Squares Mean
688189|NCT01469000|Secondary|Time to Worsening of Symptoms Using the Lung Cancer Symptom Scales (LCSS)||Baseline to Progressive Disease (Estimated Up To 18 Months)||08/2018||||
688190|NCT01469000|Secondary|Change From Baseline in Lung Cancer Symptom Scale (LCSS) Score(Symptom Control)||Baseline to Progressive Disease (Estimated Up To 18 Months )||08/2018||||
688191|NCT01469000|Secondary|Duration of Response (DoR)|DoR was defined as the time from the date of the first CR or PR to the first date of Progressive Disease (PD) ( RECIST 1.1 Criteria) or death from any cause.CR is the disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm.Tumor marker results must have normalized. PR is defined as at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. PD was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. Also,the sum must also demonstrate an absolute increase of at least 5 mm.The appearance of one or more new lesions is also considered progression. Participants not known to have died or to have had progression of disease as of the data-inclusion cut-off date for a particular analysis,duration of tumor response was censored at the date of the participants last tumor assessment prior to that cut-off date.|First Observation of CR or PR to Progressive Disease or Death Due to Any Cause (Up To 30.29 Months)|All randomized participants who received at least 1 dose of drug had evaluable baseline and post baseline data. Participants censored: Gefitinib/Pemetrexed =30, Gefitinib=7||months||95% Confidence Interval|Median
688192|NCT01469000|Secondary|Percentage of Participants With CR, PR, and Stable Disease (SD) (Disease Control Rate [DCR])|Disease control rate is the percentage of participants with a confirmed CR, PR or SD as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST version 1.1) criteria. CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Tumor marker results must have normalized. PR is defined at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|Randomization to Progressive Disease (Up To 31.38 months)|All participants who received at least 1 dose of study drug and had evaluable baseline and post baseline data.||percentage of participants|||Number
688193|NCT01469000|Secondary|Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])|ORR is the best response of complete response (CR) or partial response (PR) as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). Complete Response (CR) is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Tumor marker results must have normalized. Partial Response (PR) is defined at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters.|Randomization to Progressive Disease (Up to 31.38 Months)|All participants who received at least 1 dose of study drug and had evaluable baseline and post baseline data.||percentage of participants|||Number
688194|NCT01469000|Secondary|Overall Survival (OS)||Randomization to Progressive Disease or Death Due to Any Cause (Estimated Up to 50 Months)||08/2018||||
688195|NCT01469000|Secondary|Time To Progressive Disease (TTPD)|TTPD is defined as time from the date of randomization to the first date of disease progression. For each participant who is not known to have had a progression of disease as of the data-inclusion cut-off date for a particular analysis, or who has died without progression of disease, TTPD will be censored for that analysis at the date of the participant’s last tumor assessment prior to that cut-off date. TTPD was analyzed twice: (1) excluding clinical progressions of disease (that is,those not defined according to the RECIST version 1.1 criteria ), and (2) including clinical progressions. Progressive disease (PD) was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. Also, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). The appearance of one or more new lesions is also considered progression.|Randomization to Progressive Disease (Up To 31.38 Months)|All participants who received at least 1 dose of study drug. Participants censored: Gefitinib/Pemetrexed =44, Gefitinib=9||months||95% Confidence Interval|Median
708921|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 6||Month 6|||L||Standard Deviation|Mean
688196|NCT01469000|Primary|Progression Free Survival (PFS)|PFS is defined as the time from randomization to the first date of objectively determined progressive disease or death from any cause, whichever is earlier. The censoring is taken in the following order: If a participant didn't have a complete baseline disease assessment, then the PFS time was censored at the enrollment date, regardless of whether or not objectively determined disease progression or death has been observed for the participant; otherwise, if a participant is not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time will be censored at the last complete objective progression-free disease assessment date.|Randomization to Progressive Disease or Death Due to Any Cause (Up to 31.38 Months)|All participants who received at least 1 dose of study drug. Participants censored: Gefitinib/Pemetrexed =38, Gefitinib=9||months||95% Confidence Interval|Median
688204|NCT01468818|Secondary|Level of Persistence of the Transferred Cells in Blood|Determine level of transferred cells in the blood following a non-myeloablative lymphodepleting chemotherapy preparative regimen.|Once week and one month after transfer|No data was collected or analyzed, thus we did not perform an evaluation of persistence for this trial. The reason is that we did not accrue a sufficient number of patients in a timely manner. A minimum of 35 subjects was needed to perform an analysis.|||||
688205|NCT01468818|Primary|Objective Response in Patients With Metastatic Melanoma|Response is determined by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.|Approximately 2 Years|||participants|||Number
688206|NCT01468675|Primary|Number of Subjects Who Discussed Disease Risk With Primary Care Provider||3 months following primary care visit|1673+1847 (Total=3520) is the total number of subjects who answered the question that this outcome is derived from. (During your last doctor visit, did you talk to your PCP about your risk of developing cancer, heart disease or diabetes.) The total number of subjects included in the analysis is 3703.||Participants|||Count of Participants
688207|NCT01468584|Primary|Undetectable HCV RNA at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)||After 24 weeks of follow-up|||percentage of subjects achieving SVR||95% Confidence Interval|Number
688208|NCT01468558|Primary|AUC(0-48) of Dihydroergotamine After MAP0004, MAP0004 Co-administered With Ketoconazole, and IV DHE Administration|The AUC(0-48) is the area under the plot of plasma concentration of drug against time after drug administration. Dihydroergotamine AUC(0-48) is reported in picograms times hour per milliliter (pg*h/ml).|48 hours|Patients with available data at specified time points are included in the analysis population.||pg*h/ml||Standard Deviation|Geometric Mean
688209|NCT01468558|Primary|Cmax of Dihydroergotamine After MAP0004, MAP0004 Co-administered With Ketoconazole, and IV DHE Administration|The maximum concentration (Cmax) is the highest concentration of a drug measured in the plasma. Plasma is the clear portion of the blood. The Cmax of Dihydroergotamine is reported in picograms per milliliter (pg/ml).|48 hours|Patients with available data at specified time points are included in the analysis population.||pg/ml||Standard Deviation|Geometric Mean
688210|NCT01468350|Secondary|Measure the Effects of Both Single and Multiple Doses of Dalfampridine-ER 10 mg on Sensorimotor Function|"Hand strength as measured by a composite Z-score derived from the grip test, and key, tip and palmar pinch tests
Manual dexterity as measured by the Box and Block Test
Walking speed as measured by the Timed 25 Foot Walk (T25FW)
Gait as measured by gait analysis equipment (to be performed by sites that have the capability to perform it)
For Part B only, subjective impressions of treatment as measured by:
Subject Global Impression (SGI)
Clinician Global Impression (CGI)"|up to 31 days||||||
688211|NCT01468350|Primary|Safety and Tolerability of Dalfampridine-ER 10mg in Subjects With Cerebral Palsy (CP)|"Safety and tolerability will be assessed primarily by monitoring Treatment Emergent Adverse Events (TEAEs)
TEAEs are defined as Adverse Events (AEs) with date of onset (or worsening) on or after the start-date of double-blind treatment and no more than 5 days after the last dose of double-blind treatment for Part A of the study and no more than 9 days for Part B of the study.
The severity categories of mild, moderate or severe, are defined below:
Mild is defined as causing no limitation of usual activities
Moderate is defined as causing some limitation of usual activities
Severe is defined as causing inability to carry out usual activities"|up to 31 days|Safety Population (Took at least one dose)||participants|||Number
688220|NCT01468337|Secondary|Changes in Central Retinal Thickness as Measured on Optical Coherence Tomography (OCT) at Week 2 Compared to Baseline||Baseline and Week 2||||||
688221|NCT01468337|Secondary|Changes in the Maximum Subretinal Fluid Volume as Measured on Optical Coherence Tomography (OCT) at Week 2 Compared to Baseline||Baseline and Week 2||||||
688222|NCT01468337|Secondary|Changes in Best-corrected Visual Acuity (BCVA) in the Fellow Eye at Week 48 Compared to Baseline|"Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.
A positive change value indicates improvement of the outcome. A negative change value indicates worsening of the outcome."|Baseline and Week 48|||ETDRS letters|Participants|Full Range|Mean
688223|NCT01468337|Secondary|Changes in Best-corrected Visual Acuity (BCVA) in the Study Eye at Week 48 Compared to Baseline|"Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.
A positive change value indicates improvement of the outcome. A negative change value indicates worsening of the outcome."|Baseline and Week 48|||ETDRS letters|Participants|Full Range|Mean
688224|NCT01468337|Secondary|Changes in Best-corrected Visual Acuity (BCVA) in the Fellow Eye at Week 2 Compared to Baseline|"Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.
A positive change value indicates improvement of the outcome. A negative change value indicates worsening of the outcome."|Baseline and Week 2|||ETDRS letters|Participants|Full Range|Mean
688225|NCT01468337|Secondary|Changes in Best-corrected Visual Acuity (BCVA) in the Study Eye at Week 2 Compared to Baseline|"Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.
A positive change value indicates improvement of the outcome. A negative change value indicates worsening of the outcome."|Baseline and Week 2|||ETDRS letters|Participants|Full Range|Mean
688226|NCT01468337|Primary|Number of Participants Who Withdrew From the Study||Week 48|||participants|||Number
688227|NCT01468337|Primary|Total Number of Non-ocular Adverse Events Related to the Investigational Product||Week 48|||Adverse Events|||Number
688228|NCT01468337|Primary|Total Number of Severe Non-ocular Adverse Events Related to the Investigational Product||Week 48|||Adverse Events|||Number
688229|NCT01468337|Primary|Total Number of Ocular Adverse Events Related to Investigational Product||Week 48|||Adverse Events|||Number
688230|NCT01468337|Primary|Total Number of Severe Ocular Adverse Events Related to the Investigational Product||Week 48|||Adverse Events|||Number
688231|NCT01468311|Secondary|Overall Survival|Overall survival is defined as the time from the date of registration to the date of death due to any cause or if no death occurs to the last documented information on the patient.|OS is evaluated at day 100 post autologous stem cell transplant, then 1-4 times yearly for 5 years|||months||Full Range|Median
688232|NCT01468311|Secondary|Disease Free Survival (DFS)|DFS is defined as the amount of time participants remain disease free.|DFS is evaluated at day 100 post autologous stem cell transplant, then 1-4 times yearly for 5 years|||months||Full Range|Median
688233|NCT01468311|Secondary|Complete Response Rate|Complete response rate is defined as the time it takes a participant to achieve a complete response. Response is assessed by the Revised Response Criteria for Malignant Lymphoma. Complete response requires all of the following: complete disappearance of all detectable clinical evidence of disease and disease related symptoms if present before therapy. A post treatment residual mass is permitted as long as it is positron emission tomography (PET) negative. If a pretreatment PET scan was negative, all lymph nodes and nodal masses must have regressed on computed tomography (CT) to normal size (<1.5 cm in their greatest transverse diameter for nodes >1.5 cm before therapy); Previously involved nodes that were 1.1 to 1.5 cm in their long axis and more than 1.0 cm in their short axis before treatment must have decreased to <1.0 cm in their short axis after treatment.|20 months post autologous stem cell transplant|||months||Full Range|Median
688234|NCT01468311|Secondary|Overall Response Rate|Overall response rate is defined as the number of complete and partial responses in patients with refractory or relapsed Hodgkin's disease. Response is assessed by the Revised Response Criteria for Malignant Lymphoma. Complete response requires all of the following: complete disappearance of all detectable clinical evidence of disease and disease related symptoms if present before therapy. A post treatment residual mass is permitted as long as it is positron emission tomography negative. Partial response requires all of the following: at least a 50% reduction in the sum of the product of the diameters of up to 6 of the largest dominant nodes or nodal masses. These nodes or masses should be selected according to all of the following: they should be clearly measurable in at least two perpendicular dimensions; if possible they should be from disparate regions of the body; and they should include mediastinal and retroperitoneal areas of disease whenever these sites are involved.|Response is evaluated at day 100 post autologous stem cell transplant, then 1-4 times yearly for 5 years|||Participants|||Count of Participants
688235|NCT01468311|Primary|Number of Participants With A Dose Limiting Toxicity|Patients who develop either a Common Terminology Criteria in Adverse Events (CTCAE) v4.0 grade 3 or greater non-hematologic toxicity, with the exception of fatigue, of more than 5 days duration possibly, probably or definitely related to the infusion of 90Y-daclizumab prior to the start of Carmustine, Etoposide, Cytarabine, [Ara-C, Cytosine Arabinoside] and Melphalan (BEAM) chemotherapy (Day - 6) will have developed by definition a dose-limiting toxicity (DLT).|30 months|||Participants|||Count of Participants
688254|NCT01468077|Secondary|Percentage of Participants With Improvement of at Least 0.22 Units in M-HAQ Compared to Baseline Per Visit Among Participants Who Completed All Visits|M-HAQ is a self-reported, valid assessment of functional disability in RA. Assessment based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. Scores range 0 to 3; without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3.|Weeks 4, 8. 12, 20, and 24|ITT Completers||Percentage of Participants|||Number
688236|NCT01468311|Primary|Number of Participants With Adverse Events|Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|30 months|||Participants|||Count of Participants
688237|NCT01468311|Primary|Maximum Tolerated Dose (MTD) of 90Y-daclizumab With Carmustine, Etoposide, Cytarabine, [Ara-C, Cytosine Arabinoside] and Melphalan (BEAM) and Auto Stem Cell Transplant (ASCT): Phase I Portion|The MTD is defined as the dose level below the dose at which 2 out of 2 to 6 patients at a given dose level develop dose limiting toxicity (DLT). A DLT is defined as patients who develop either a Common Terminology Criteria in Adverse Events (CTCAE) v4.0 grade 3 or greater non-hematologic toxicity, with the exception of fatigue, of more than 5 days duration possibly, probably or definitely related to the infusion of 90Y-daclizumab prior to the start of BEAM chemotherapy (Day - 6) will have developed by definition a dose-limiting toxicity (DLT).|Day 100 post autologous stem cell transplant|MTD was not determined due to low enrollment into the study.|||||
688238|NCT01468233|Secondary|Change From Baseline to Week 12 in Modified Sartorius Score|The Sartorius Scale is used to quantify the severity of HS. Points are awarded for 12 body areas (left and right axillae, left and right sub/inframammary areas, intermammary area, left and right buttocks, left and right inguino-crural folds, perianal area, perineal area, and other): points were awarded for nodules (2 points for each); abscesses (4 points); fistulas (4 points); scars (1 point); other findings (1 point); and longest distance between two lesions (2-6 points, 0 if no lesions); and if lesions are separated by normal skin (yes-0 points; no-6 points). The total Sartorius score is the sum of the 12 regional scores. Last Observation Carried Forward (LOCF): The last completed evaluation from the previous visit within the particular period for efficacy measures was carried forward to impute missing data at later visits in the same period. Baseline efficacy evaluations were not carried forward.|Baseline (Week 0) and Week 12|Participants in the ITT population||units on a scale||Standard Error|Least Squares Mean
688239|NCT01468233|Secondary|Percentage of Participants Achieving At Least 30% Reduction and At Least 1 Unit Reduction From Baseline in Patient's Global Assessment of Skin Pain (NRS30) – At Worst at Week 12 Among Participants With Baseline Skin Pain NRS ≥ 3|"The Patient's Global Assessment of Skin Pain Numeric Rating Scale (NRS) was used to assess the worst skin pain and the average skin pain due to HS. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The assessments were completed on a daily diary by participants before they went to bed and responded to the items based on a recall period of the last 24 hours. The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline in the Patient's Global Assessment of Skin Pain (NRS30) – at worst at Week 12 among participants with Baseline NRS ≥ 3 is presented. Weekly averages of daily assessments were analyzed. NRI: Participants with missing data were considered non-responders."|Baseline (Week 0) up to Week 12|Participants in the ITT population with baseline NRS at Worst ≥ 3||percentage of participants|||Number
688240|NCT01468233|Secondary|Percentage of Participants With Baseline Hurley Stage II Who Achieved Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2 at Week 12|The percentage of participants with AN counts lowered to 0, 1, or 2 at Week 12 among participants with Hurley Stage II at Baseline. NRI: Participants with missing data were considered nonresponders.|Baseline (Week 0) up to Week 12|Participants in the ITT population with baseline Hurley Stage II||percentage of participants|||Number
688241|NCT01468233|Primary|Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12|HiSCR was defined as at least a 50% reduction in abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count at Week 12 relative to Baseline. Data are presented for all participants and by baseline Hurley Stage (Stage 1: Abscess formation, single or multiple, without sinus tracts and scarring; Stage II: One or more widely separated recurrent abscesses with tract formation and scars. A participant with at least 1 anatomic region with Hurley Stage II disease and with no anatomic regions with Hurley Stage III disease was classified as Hurley Stage II; and Stage III: Multiple interconnected tracts and abscesses across the entire area, with diffuse or near diffuse involvement. A participant with at least 1 anatomic region with Hurley Stage III disease was classified as Hurley Stage III). Non-responder imputation (NRI): Participants with missing data were considered non-responders.|Baseline (Week 0) up to Week 12|The intention-to-treat (ITT) population, defined as all participants who were randomized at Baseline (Week 0), was analyzed overall and by baseline Hurley Stage||percentage of participants|||Number
688242|NCT01468207|Secondary|Change From Baseline to Week 12 in Modified Sartorius Score|The Sartorius Scale is used to quantify the severity of HS. Points are awarded for 12 body areas (left and right axillae, left and right sub/inframammary areas, intermammary area, left and right buttocks, left and right inguino-crural folds, perianal area, perineal area, and other): points were awarded for nodules (2 points for each); abscesses (4 points); fistulas (4 points); scars (1 point); other findings (1 point); and longest distance between two lesions (2-6 points, 0 if no lesions); and if lesions are separated by normal skin (yes-0 points; No-6 points). The total Sartorius score is the sum of the 12 regional scores. Last Observation Carried Forward (LOCF): The last completed evaluation from the previous visit within the particular period for efficacy measures was carried forward to impute missing data at later visits in the same period. Baseline efficacy evaluations were not carried forward.|Baseline (Week 0) and Week 12|Participants in the ITT population||units on a scale||Standard Error|Least Squares Mean
688255|NCT01468077|Secondary|Modified Health Assessment Questionnaire (M-HAQ) Score by Visit Among Participants Who Completed All Visits|M-HAQ is a self-reported, valid assessment of functional disability in RA. Assessment based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. Scores range 0 to 3; without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3.|Baseline, Weeks 4, 8, 12, 20, and 24|ITT Completers||scores on a scale||Standard Deviation|Mean
688598|NCT01465178|Primary|Change in Serum 25-hydroxy Vitamin D3|Our primary outcome variable is the effect of supplementation on change in serum 25(OH)D3;|Baseline, 1 and 4 months post supplementation|||ng/ml||Standard Deviation|Mean
688243|NCT01468207|Secondary|Percentage of Participants Achieving At Least 30% Reduction and At Least 1 Unit Reduction From Baseline in Patient's Global Assessment of Skin Pain (NRS30) – At Worst at Week 12 Among Participants With Baseline Skin Pain NRS ≥ 3|"The Patient's Global Assessment of Skin Pain Numeric Rating Scale (NRS) was used to assess the worst skin pain and the average skin pain due to HS. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The assessments were completed on a daily diary by participants before they went to bed and responded to the items based on a recall period of the last 24 hours. The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline in the Patient's Global Assessment of Skin Pain (NRS30) – at worst at Week 12 among participants with Baseline NRS ≥ 3 are presented. Weekly averages of daily assessments were analyzed. NRI: Participants with missing data were considered non-responders."|Baseline (Week 0) up to Week 12|Participants in the ITT population with baseline NRS at Worst ≥ 3||percentage of participants|||Number
688244|NCT01468207|Secondary|Percentage of Participants With Baseline Hurley Stage II Who Achieved Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2 at Week 12|The percentage of participants with AN counts lowered to 0, 1, or 2 at Week 12 among participants with Hurley Stage II at Baseline. NRI: Participants with missing data were considered non-responders.|Baseline (Week 0) up to Week 12|Participants in the ITT population with baseline Hurley Stage II||percentage of participants|||Number
688245|NCT01468207|Primary|Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12|HiSCR was defined as at least a 50% reduction in abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count at Week 12 relative to Baseline. Data are presented for all participants and by baseline Hurley Stage (Stage 1: Abscess formation, single or multiple, without sinus tracts and scarring; Stage II: One or more widely separated recurrent abscesses with tract formation and scars. A participant with at least 1 anatomic region with Hurley Stage II disease and with no anatomic regions with Hurley Stage III disease was classified as Hurley Stage II; and Stage III: Multiple interconnected tracts and abscesses across the entire area, with diffuse or near diffuse involvement. A participant with at least 1 anatomic region with Hurley Stage III disease was classified as Hurley Stage III). Non-responder imputation (NRI): Participants with missing data were considered non-responders.|Baseline (Week 0) up to Week 12|The intention-to-treat (ITT) population, defined as all participants who were randomized at Baseline (Week 0), was analyzed overall and by baseline Hurley Stage||percentage of participants|||Number
688246|NCT01468181|Secondary|Change From Baseline in Updated Homeostasis Model Assessment (HOMA2)|The HOMA2 is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state pancreatic beta cell function (%B) and to estimate insulin sensitivity (%S) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. The change from baseline for fasting insulin concentrations are presented as insulin secretion (HOMA2-%B) and insulin sensitivity (HOMA2-%S).|Baseline, up to 26 weeks and up to 52 weeks|Participants who were randomized and received at least 1 dose of study drug with evaluable HOMA2 data. LOCF was used to impute missing postbaseline values.||percentage of HOMA2||Standard Error|Mean
688247|NCT01468181|Secondary|Change From Baseline in Body Weight||Baseline, up to 26 weeks and up to 52 weeks|Participants who were randomized and received at least 1 dose of study drug with evaluable body weight data. LOCF was used to impute missing postbaseline values.||kilograms (kg)||Standard Error|Mean
688248|NCT01468181|Secondary|Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG)|Participants were to test and record SMBG concentrations in their study diaries before each meal (breakfast, lunch, and dinner), approximately 2 hours after the start of each meal. For the mean of all 7-point blood glucose values, the daily mean was calculated as the average of 7 blood glucose values collected on a particular day. The mean of all 7-point blood glucose values at each visit was calculated as the average of 2 daily means. The change from baseline was calculated as the mean of all 7-point blood glucose values at endpoint minus the mean of all 7-point blood glucose values at baseline.|Baseline, up to 26 weeks and up to 52 weeks|Participants who were randomized and received at least 1 dose of study drug with evaluable SMBG data. LOCF was used to impute missing postbaseline. values.||mg/dL||Standard Error|Mean
688249|NCT01468181|Secondary|Change From Baseline in Fasting Blood Glucose (FBG)||Baseline, up to 26 weeks and up to 52 weeks|Participants who were randomized and received at least 1 dose of study drug with evaluable FBG data. LOCF was used to impute missing postbaseline values.||milligrams/deciliters (mg/dL)||Standard Error|Mean
688250|NCT01468181|Secondary|Percentage of Participants Who Achieve HbA1c ≤6.5% or <7%||26 weeks and 52 weeks|Participants who were randomized and received at least 1 dose of study drug with evaluable HbA1c data. LOCF was used to impute missing postbaseline values.||percentage of participants|||Number
688251|NCT01468181|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)||Baseline, up to 26 Weeks and up to 52 Weeks|Participants who were randomized and received at least 1 dose of study drug with evaluable HbA1c data. Last observation carried forward (LOCF) was used to impute missing postbaseline values.||percentage of HbA1c||Standard Error|Mean
688252|NCT01468181|Primary|Percentage of Participants With Hypoglycemic Episodes|The percentage of participants with hypoglycemic episodes was calculated by dividing the number of participants with at least 1 hypoglycemic episode over the 52-week treatment period by the total number of participants analyzed, multiplied by 100%. All classifications of hypoglycemia (documented symptomatic, asymptomatic, severe, nocturnal, non-nocturnal, probable symptomatic, relative, and unspecified) were included, except for episodes of relative hypoglycemia that were not severe. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.|Baseline through 52 Weeks|All enrolled participants who received at least 1 dose of study drug||percentage of participants|||Number
688253|NCT01468181|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)|A TEAE was defined as an event that first occurs or worsens (increases in severity) after baseline, regardless of causality or severity. The percentage of participants with TEAEs was calculated by dividing the number of participants with at least 1 TEAE over the 52-week treatment period by the total number of participants analyzed, multiplied by 100%. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.|Baseline through 52 Weeks|All enrolled participants who received at least 1 dose of study drug||percentage of participants|||Number
709934|NCT00140244|Secondary|Glycemia (as Assessed by Fasting Glucose)||At the end of each two month intervention|||mg/dl||Standard Error|Mean
688256|NCT01468077|Secondary|High Sensitivity C-Reactive Protein (hsCRP) Levels by Visit Among Participants Who Completed All Visits|hsCRP is a marker for inflammation and is measured in milligrams per liter (mg/L). High levels of this protein indicate inflammation in diseases such as RA.|Screening, Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT Completers||mg/L||Standard Deviation|Mean
688257|NCT01468077|Secondary|Percentage of Participants Achieving ACR 90% Improvement (ACR90 Response) by Visit Among Participants Who Completed All Visits|ACR90 response is defined as an improvement of ≥90% in SJC (66 joints) and TJC (68 joints) as well as ≥90% improvement in at least 3 of the following 5 remaining ACR assessments: Patient Global Assessment of Pain; Patient Global Assessment of Disease Activity; Physician Global Assessment of Disease Activity; HAQ-DI; and acute phase reactive factors (ESR or CRP).|Weeks 4, 8, 12, 16, 20 and 24|ITT Completers||Percentage of Participants|||Number
688258|NCT01468077|Secondary|Percentage of Participants Achieving ACR 70% Improvement (ACR70 Response) by Visit, Among Participants Who Completed All Visits|ACR70 response is defined as an improvement of ≥70% in SJC (66 joints) and TJC (68 joints) as well as ≥70% improvement in at least 3 of the following 5 remaining ACR assessments: Patient Global Assessment of Pain; Patient Global Assessment of Disease Activity; Physician Global Assessment of Disease Activity; HAQ-DI; and acute phase reactive factors (ESR or CRP).|Weeks 4, 8, 12, 16, 20 and 24|ITT Completers||Percentage of Participants|||Number
688259|NCT01468077|Secondary|Percentage of Participants Achieving ACR 50% Improvement (ACR50 Response) by Visit Among Participants Who Completed All Visits|ACR50 response is defined as an improvement of ≥50% in SJC (66 joints) and TJC (68 joints) as well as ≥50% improvement in at least 3 of the following 5 remaining ACR assessments: Patient Global Assessment of Pain; Patient Global Assessment of Disease Activity; Physician Global Assessment of Disease Activity; HAQ-DI; and acute phase reactive factors (ESR or CRP).|Weeks, 4, 8, 12, 16, 20, and 24|ITT Completers||Percentage of Participants|||Number
688260|NCT01468077|Secondary|Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) Improvement (ACR20 Response) by Visit Among Participants Who Completed All Visits|ACR20 response is defined as an improvement of ≥20% in swollen joint count (SJC; 66 joints) and tender joint count (TJC; 68 joints) as well as ≥20% improvement in at least 3 of the following 5 remaining ACR assessments: Patient Global Assessment of Pain; Patient Global Assessment of Disease Activity; Physician Global Assessment of Disease Activity; Health Assessment Questionnaire - Disability Index (HAQ-DI); and acute phase reactive factors (Erythrocyte Sedimentation Rate [ESR] or C-Reactive Protein [CRP]).|Weeks 4, 8, 12, 16, 20, and 24|ITT Completers||Percentage of Participants|||Number
688261|NCT01468077|Secondary|DAS28 Score by Visit Among Participants Who Completed All Visits|Improvement in RA disease activity was measured by the DAS28 score, which is an index combining measurements of swollen and tender joints, acute phase response hsCRP, and global assessment of disease activity by the participant. A clinically meaningful improvement was defined as a reduction of at least 1.2 units in the DAS28 score during the study period. A low disease activity was defined as a DAS28 score <3.2, and remission was defined as a DAS28 score <2.6.|Baseline, Weeks, 4, 8, 12, 16, 20, and 24|ITT Completers; n = the number of participants analyzed for the given parameter at the specific visit.||scores on a scale||Standard Deviation|Mean
688262|NCT01468077|Secondary|Percentage of Participants Achieving a DAS28 Score Below 2.6 (Remission) by Visit Among Participants Who Completed All Visits|Improvement in RA disease activity was measured by the DAS28 score, which is an index combining measurements of swollen and tender joints, acute phase response hsCRP, and global assessment of disease activity by the participant. A clinically meaningful improvement was defined as a reduction of at least 1.2 units in the DAS28 score during the study period. A low disease activity was defined as a DAS28 score <3.2, and remission was defined as a DAS28 score <2.6.|Weeks 4, 8, 12, 16, 20, and 24|ITT Completers||Percentage of Participants|||Number
688263|NCT01468077|Secondary|Percentage of Participants Achieving a DAS28 Score Below 3.2 (Low Disease Activity) by Visit Among Participants Who Completed All Visits|Improvement in RA disease activity was measured by the DAS28 score, which is an index combining measurements of swollen and tender joints, acute phase response hsCRP, and global assessment of disease activity by the participant. A clinically meaningful improvement was defined as a reduction of at least 1.2 units in the DAS28 score during the study period. A low disease activity was defined as a DAS28 score <3.2, and remission was defined as a DAS28 score <2.6.|Weeks 4, 8, 12, 16, 20, and 24|ITT Completers||Percentage of Participants|||Number
688264|NCT01468077|Secondary|Percentage of Participants With a Reduction of at Least 1.2 Points in Disease Activity Score Based on 28-Joint Count (DAS28) by Visit Among Participants Who Completed All Visits|Improvement in Rheumatoid Arthritis (RA) disease activity was measured by the DAS28 score, which is an index combining measurements of swollen and tender joints, acute phase response High sensitivity C-Reactive Protein (hsCRP), and global assessment of disease activity by the participant. A clinically meaningful improvement was defined as a reduction of at least 1.2 units in the DAS28 score during the study period. A low disease activity was defined as a DAS28 score less than (<)3.2, and remission was defined as a DAS28 score <2.6.|Weeks 4, 8, 12, 16, 20, and 24|ITT Completers||Percentage of Participants|||Number
688265|NCT01468077|Secondary|Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits|Increased levels of high density lipoproteins (HDL) equal to or greater than (≥)1.5 millimoles per liter (mmol/L), and low density lipoproteins (LDL) ≥4.1 mmol/L, and total cholesterol ≥5.1 mmol/L, are defined according to the Adult Treatment Panel III (ATP-III) guidelines.|Screening and Weeks 4, 8, 12, 16, 20, and 24|ITT Completers||Percentage of Participants|||Number
688266|NCT01468077|Secondary|Percentage of Participants With Increased Liver Enzyme Values of Greater Than (>)1.5 Times, or >3 Times, or >5 Times Over the Upper Limit of Normal (ULN) by Visit Among Participants Who Completed All Visits|"Increased liver enzyme values defined as Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) values of >1.5 times, or >3 times, or >5 times over the ULN. Almost none of the participants had increased measurements of AST, thus only values of ALT were presented. None of the participants presented with increased values of ALT above 3 or 5 ULN at any of the visits.
ITT Completers is defined as a subset of the participants in the ITT population who completed all study visits."|Baseline and Weeks 4, 8, 12, 16, 20, and 24|ITT Completers with liver enzyme datasets for each analyzed visit||Percentage of Participants|||Number
688267|NCT01468077|Secondary|Percentage of Participants Discontinuing Tocilizumab for Other Reasons|Participants that stopped the administration of tocilizumab and discontinued the study prematurely due to reasons other than an AE or SAE were analyzed.|Baseline and Weeks, 4, 8, 12, 16, 20, and 24|SAS Population||Percentage of Participants|||Number
688268|NCT01468077|Secondary|Percentage of Participants Discontinuing Tocilizumab in Response to an AE or a Serious Adverse Event (SAE)|All occurrences of participants who received at least 1 infusion of tocilizumab and then stopped tocilizumab infusions due to an AE or SAE were analyzed.|Baseline (Day 1) and Weeks 4, 8, 12, 16, 20, and 24|SAS Population||Percentage of Participants|||Number
688269|NCT01468077|Primary|Percentage of Participants With Any Infusion Reaction|An infusion reaction was defined as any adverse event (AE) that occurred during the infusion or during the 24 hours following the infusion and deemed possibly or probably related to tocilizumab.|Baseline (Day 1), and Weeks 4, 8, 12, 16, and 20|Safety Analysis Set (SAS) Population: All randomized participants who received at least one infusion of tocilizumab.||Percentage of Participants|||Number
688270|NCT01468012|Primary|Retention in Treatment|The number of participants who completed the 12-week medication phase of the study.|12 weeks|||participants|||Number
688271|NCT01468012|Primary|Cocaine Urine Toxicology|Abstinence will be assessed by urine toxicology results collected 3x/week during the 24 week trial or for the length of participation|collected 3x/week for 24 weeks of trial or for the duration of the participants involvement in the study.||||||
688272|NCT01467960|Primary|Detection of Apolipoprotein D|Apolipoprotein D (apoD)concentration in human serum as a potential marker for Parkinson's disease (PD)|Baseline|||microg / ml||Standard Deviation|Mean
688273|NCT01467947|Secondary|Number of Subjects With Any (Inhibitory or Non-inhibitory) Anti-C1-esterase-inhibitor Antibodies|Subjects with at least one positive result for inhibitory or non-inhibitory anti-C1-INH antibodies.|Baseline to approximately 9 months|||Subjects|||Number
688274|NCT01467947|Primary|Number of Subjects With Inhibitory Anti-C1-esterase-inhibitor Antibodies|Subjects with no positive baseline result and at least one positive post-baseline result for inhibitory anti-C1-INH antibodies.|Baseline to approximately 9 months|||subjects|||Number
688275|NCT01467934|Primary|Fever >= 100.4||8 days|Participants in analysis included those for whom both day 0 and day 1 temperature data was reported.||percentage of participants|||Number
688276|NCT01467882|Secondary|Percentage of Boys With Absence of Progression of Testis Volumes Compared to Baseline at Months 6 and 12||Baseline to Months 6 and 12|Intention to treat boys, defined as all boys enrolled||percentage of participants|||Number
688277|NCT01467882|Secondary|Percentage of Girls With Regression of Uterine Length Compared to Baseline at Months 6 and 12||Baseline to Months 6 and 12|Intention to treat girls, defined as all girls enrolled||percentage of participants|||Number
688278|NCT01467882|Secondary|Percentage of Children Achieving Stabilization of Sexual Maturation at Months 6 and 12||at Months 6 and 12|Intention to treat, defined as all participants enrolled||percentage of participants|||Number
688279|NCT01467882|Secondary|Percentage of Participants Without Bone Age / Chronological Age Ratio Increase From Baseline at Months 6 and 12||Baseline to Months 6 and 12|Intention to treat, defined as all participants enrolled||percentage of participants|||Number
688280|NCT01467882|Secondary|Change From Baseline in Growth Velocity at Months 6 and 12||Baseline to Months 6 and 12|Intention to treat, defined as all participants enrolled||cm/year||Standard Deviation|Mean
688281|NCT01467882|Secondary|Change From Baseline in Height-for-age Percentile Per 2000 CDC Growth Charts at Months 6 and 12||Baseline to Months 6 and 12|Intention to treat, defined as all participants enrolled||percentile||Standard Deviation|Mean
688282|NCT01467882|Secondary|Change From Baseline in Height-for-age Z-score Per 2000 CDC Growth Charts at Months 6 and 12||Baseline to Months 6 and 12|Intention to treat, defined as all participants enrolled||Z-score||Standard Deviation|Mean
688283|NCT01467882|Secondary|Percentage of Children Without Higher Basal LH and Estradiol or Testosterone||at 2 days after second triptorelin injection (Day 171)|AOC Subset is defined as 50% of the population randomly assigned||percentage of participants|||Number
688284|NCT01467882|Secondary|Percentage of Children With Prepubertal Estradiol or Testosterone Levels at Months 1, 2, 3, 6, 9, and 12||at Months 1, 2, 3, 6, 9, and 12|Intention to treat, defined as all participants enrolled||percentage of participants|||Number
688285|NCT01467882|Secondary|Change From Baseline in Testosterone Levels at Months 1, 2, 3, 6, 9, and 12||Baseline to Months 1, 2, 3, 6, 9, and 12|Intention to treat boys, defined as all boys enrolled||ng/dL||Standard Deviation|Mean
688286|NCT01467882|Secondary|Change From Baseline in Estradiol Levels at Months 1, 2, 3, 6, 9, and 12||Baseline to Months 1, 2, 3, 6, 9, and 12|Intention to treat girls, defined as all girls enrolled||ng/L||Standard Deviation|Mean
688287|NCT01467882|Secondary|Change From Baseline in Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) at Months 1, 2, 3, 6, 9, and 12||Baseline to Months 1, 2, 3, 6, 9, and 12|Intention to treat, defined as all participants enrolled||IU/L||Standard Deviation|Mean
688288|NCT01467882|Secondary|Percentage of Children Maintaining LH Suppression at </= 4 IU/L 30 Minutes After Leuprolide Stimulation From Month 6 to 12|This is a lab test to see what percentage of children stayed at the lower than normal before-puberty level from month 6 to month 12.|from Month 6 to 12|Intention to treat, defined as all participants enrolled||percentage of participants|||Number
688289|NCT01467882|Secondary|Percentage of Children With LH Suppression (LH ≤ 4 IU/L)30 Minutes After Leuprolide Stimulation at Months 1, 2, 3, 6, 9 and 12|This is a lab test to see what percentage of children were returned to lower than normal before-puberty levels by the drug at each time point.|at Months 1, 2, 3, 6, 9 and 12|Intention to treat, defined as all participants enrolled||percentage of participants|||Number
688290|NCT01467882|Secondary|Percentage of Children Maintaining LH Suppression at Prepubertal Levels 30 Minutes After Leuprolide Stimulation From Month 6 to 12|This is a lab test to see what percentage of children stayed at the normal before-puberty level from month 6 to month 12.|from Month 6 to 12|Intention to treat, defined as all participants enrolled||percentage of participants|||Number
688291|NCT01467882|Secondary|Percentage of Children With LH Suppression to Prepubertal Levels 30 Minutes After Leuprolide Stimulation at Months 1, 2, 3, 9 and 12|This is a lab test to see what percentage of children were returned to normal before-puberty levels by the drug at each time point.|at Months 1, 2, 3, 9 and 12|Intention to treat, defined as all participants enrolled||percentage of participants|||Number
688292|NCT01467882|Primary|Percentage of Children With Luteinizing Hormone (LH) Suppression to Prepubertal Levels 30 Minutes After Leuprolide Stimulation at Month 6|This is a lab test to see what percentage of participants were returned to normal before-puberty levels at Month 6.|Month 6|Intention to treat, defined as all participants enrolled||percentage of participants||95% Confidence Interval|Number
688293|NCT01467713|Secondary|Quality of Life, Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) Total Score|Q-LES-Q-SF is a self-administered 16-item questionnaire to assess the degree of enjoyment and satisfaction experienced by patients in various areas of daily functioning. It includes 30 items across five subscales (daily activities, clothing, diet/food habits, relationship, psychological well-being and distress), scored on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (all the time). For reporting purposes, the scores are reversed and higher scores reflect improved quality of life and positive changes relative to baseline indicate improved quality of life.|Baseline and Months 1, 2, 3, 4, 5, 6, 7, 8, 10 and 12|Participants from the Full Analysis Set, all randomized participants who received at least 1 dose of study drug and had at least one valid post-baseline value for assessment of primary efficacy, with available data.||percent of maximum total score||Standard Deviation|Mean
688294|NCT01467713|Secondary|Time From Randomization to Study Withdrawal for Any Reason|The time from randomization to study withdrawal during the 12 month double-blind treatment period. Withdrawal includes pretreatment event/adverse event; liver function test abnormalities; major protocol deviation; lost to follow-up; voluntary withdrawal; study termination; pregnancy; lack of efficacy; participant has a depressive, mania/hypomania or mixed episode; is hospitalized for psychiatric reasons; receives electroconvulsive therapy for bipolar disorder; receives any psychotropic medication change prescribed for the treatment of depression, mania/hypomania or mixed episodes; or any other reason.|Randomization to Month 12 double-blind treatment period|Full Analysis Set included all randomized participants who received at least 1 dose of study drug and had at least one valid post-baseline value for assessment of primary efficacy.||days||Standard Error|Mean
688295|NCT01467713|Secondary|Time From Randomization to Relapse Due to Psychotropic Medication Change Prescribed for the Treatment of Depression, Mania/Hypomania or Mixed Episodes|The time from randomization to relapse event during the 12 month double-blind treatment period due to any psychotropic medication change prescribed for the treatment of depression, mania/hypomania or mixed episode(s).|Randomization to Month 12 double-blind treatment period|Full Analysis Set included all randomized participants who received at least 1 dose of study drug and had at least one valid post-baseline value for assessment of primary efficacy. Participants without relapse were censored.||days||Standard Error|Mean
688296|NCT01467713|Secondary|Time From Randomization to Relapse Due to Electroconvulsive Therapy (ECT) Administration|The time from randomization to relapse event during the 12 month double-blind treatment period due to ECT.|Randomization to Month 12 double-blind treatment period|Full Analysis Set included all randomized participants who received at least 1 dose of study drug and had at least one valid post-baseline value for assessment of primary efficacy. Participants without relapse were censored.||days||Standard Error|Mean
688297|NCT01467713|Secondary|Time From Randomization to Relapse Due to Psychiatric Hospitalization for Bipolar Disorder|The time from randomization to relapse event during the 12 months double-blind treatment period due to psychiatric hospitalization for bipolar disorder.|Randomization to Month 12 double-blind treatment period|Full Analysis Set included all randomized participants who received at least 1 dose of study drug and had at least one valid post-baseline value for assessment of primary efficacy. Participants without relapse were censored.||days||Standard Error|Mean
688298|NCT01467713|Secondary|Time From Randomization to Relapse Due to Mixed Episode|Relapse due to Mixed episode is determined by PI judgement and/or MADRS score ≥16 and YMRS total score ≥16. MADRS is a 10-item scale that measures overall severity of depressive symptoms rated on a 7-point Likert scale from 0 (normal) to 6 (most abnormal) with a total score range from 0 to 60. YMRS is a four item scale to assess manic symptoms, rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe), with 7 items rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score is calculated as the sum of the 11 individual item scores and ranges from 0-60.|Randomization to Month 12 double-blind treatment period|Full Analysis Set included all randomized participants who received at least 1 dose of study drug and had at least one valid post-baseline value for assessment of primary efficacy. Participants without relapse were censored.||days||Standard Error|Mean
688299|NCT01467713|Secondary|Time From Randomization to Relapse Due to Mania/Hypomania|Relapse due to mania/hypomania is determined by the primary investigator (PI) judgement and/or a YMRS total score ≥16. YMRS is a 11 item scale with four items scale to assess manic symptoms, rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe), with 7 items rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe) with higher scores reflecting greater levels of mania. The YMRS total score is calculated as the sum of the 11 individual item scores and ranges from 0-60.|Randomization to 12 Month double-blind treatment period|Full Analysis Set included all randomized participants who received at least 1 dose of study drug and had at least one valid post-baseline value for assessment of primary efficacy. Participants without relapse were censored.||days||Standard Error|Mean
688300|NCT01467713|Secondary|Time From Randomization to Relapse Due to Depression From PI Judgement and/or MADRS ≥16|The time from randomization to relapse event during the 12 month double-blind treatment period due to depression, determined by the PI judgement and/or a MADRS score ≥16. MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (i.e., apparent sadness, reported sadness, inner tension, etc.) rated on a 7-point Likert scale from 0 (normal) to 6 (most abnormal) with a total score range from 0 to 60. Higher scores indicate greater severity of symptoms.|Randomization to Month 12 double-blind treatment period|Full Analysis Set included all randomized participants who received at least 1 dose of study drug and had at least one valid post-baseline value for assessment of primary efficacy. Participants without relapse were censored.||days||Standard Error|Mean
688301|NCT01467713|Secondary|Time From Randomization to Relapse Due to Mania/Hypomania or Mixed Episode|Relapse due to mania/hypomania or mixed episode is determined by any of the following criteria: PI judgment, mania/hypomania [YMRS ≥16], mixed episode [MADRS ≥16 and YMRS ≥16], psychiatry hospitalization, ECT or any psychotropic medication change prescribed for the treatment of mania/hypomania or mixed episodes.|Randomization to Month 12 double-blind treatment period|Full Analysis Set included all randomized participants who received at least 1 dose of study drug and had at least one valid post-baseline value for assessment of primary efficacy. Participants without relapse were censored.||days||Standard Error|Mean
688599|NCT01465048|Secondary|Dynamics of Plasmodium Falciparum Parasite Growth Following PfSPZ Challenge Administered in Various Regimens|To determine the parasite growth dynamics of PfSPZ Challenge administered in various regimens using highly sensitive PCR for Plasmodium falciparum DNA.|21 days post administration of PfSPZ Challenge||||||
688302|NCT01467713|Secondary|Time From Randomization to Relapse Due to Depression|Relapse due to depression determined by any of the following criteria during the 12-month double-blind treatment period: PI judgment, MADRS ≥16, psychiatry hospitalization, ECT or any psychotropic medication change prescribed for the treatment of depressive episodes.|Randomization to Month 12 double-blind treatment period|Full Analysis Set included all randomized participants who received at least 1 dose of study drug and had at least one valid post-baseline value for assessment of primary efficacy. Participants without relapse were censored.||Days||Standard Error|Mean
688303|NCT01467713|Primary|Time From Randomization to Any Relapse|The time from randomization to relapse over 12 months double-blind treatment period as determined by the Principal Investigator (PI) or defined by any of the following criteria: depression [Montgomery-Åsberg Depression Rating Scale (MADRS) score ≥16]; mania/hypomania [Young Mania Rating Scale (YMRS) total score ≥14]; mixed episode [MADRS score ≥16 and YMRS total score ≥16]; or, whether participant receives psychiatric hospitalization for bipolar disorder, electroconvulsive therapy (ECT) or any psychotropic medication change prescribed for the treatment of depression, mania/hypomania or mixed episodes.|Randomization to Month 12 double-blind treatment period|Full Analysis Set included all randomized participants who received at least 1 dose of study drug and had at least one valid post-baseline value for assessment of primary efficacy. Participants without relapse were censored.||Days||Standard Error|Mean
688304|NCT01467700|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 6|The SDS comprises patient-rated items designed to measure the extent to which the subject’s life is impaired by panic, anxiety, phobic, or depressive symptoms. The participant rates the extent to which his or her (1) work, (2) social life or leisure activities, and (3) home life or family responsibilities, are impaired by his or her symptoms on 10-point visual analogue scales from 0 (not at all) to 10 (extremely) with a total score range from 0 to 30. Higher scores indicate greater severity of impairment. There are verbal descriptors for the points on the scales as well as numerical scores that provide more precise levels of the verbal descriptors. In addition, the SDS addresses the number of days lost and the number of days under-productive due to the symptoms. A negative change from Baseline indicates improvement. A MMRM model was used for analysis with baseline*week, pooled center, week, treatment, baseline, and week*treatment as factors in the analysis.|Baseline and Week 6|Participants from FAS, all randomized participants who, received at least 1 dose of study drug, and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analyses.||score on a scale||Standard Error|Least Squares Mean
688305|NCT01467700|Secondary|Change From Baseline in the Quick Inventory of Depressive Symptomatology - Self-Rated16 (QIDS-SR16) Total Score at Week 6|The 16 item QIDS-SR16 version is designed to assess the severity of depressive symptoms. The QIDS-SR16 assesses all the criterion symptom domains designated by the American Psychiatry Association Diagnostic and Statistical Manual of Mental Disorders - 4th edition, DSM-IV, to diagnose a major depressive episode. QIDS-SR16 assessment has been used to screen for depression and also to measure symptom severity. This scale is also used to distinguish response from remission, as well as to quantify between group treatments effects in open label and randomized controlled trials. The patient is asked to rate the severity and frequency of specific symptoms present over the last 7 days. The QIDS-SR16 total scores range from 0 to 27. Higher scores indicate greater severity of impairment. A negative change from Baseline indicates improvement. A MMRM model was used for analysis with baseline*week, pooled center, week, treatment, baseline, and week*treatment as factors in the analysis.|Baseline and Week 6|Participants from FAS, all randomized participants who, received at least 1 dose of study drug, and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analyses.||score on a scale||Standard Error|Least Squares Mean
688306|NCT01467700|Secondary|Percentage of Participants With MADRS Remission at Week 6, With Remission Defined as a MADRS Total Score ≤10|MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (i.e., apparent sadness, reported sadness, inner tension, etc.) rated on a 7-point Likert scale from 0 (normal) to 6 (most abnormal) with a total score range from 0 to 60. Higher scores indicate greater severity of symptoms.|Week 6|Participants from FAS, all randomized participants who, received at least 1 dose of study drug, and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analyses.||percentage of participants|||Number
688307|NCT01467700|Secondary|Change From Baseline in Clinical Global Impression Scale-Severity (CGI-S) at Week 6|"The CGI-S at week 6 relative to Baseline. The CGI-S assesses the clinician's impression of the participant's current state of mental illness and consists of one question for the investigator: Considering your total clinical experience with this particular population, how mentally ill is the patient at this time? which is rated on a seven-point scale (1=normal, not ill at all; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill). Higher scores indicate greater severity of illness. A MMRM model was used for analysis with baseline*week, pooled center, week, treatment, baseline, and week*treatment as factors in the analysis."|Baseline and Week 6|Participants from FAS, all randomized participants who, received at least 1 dose of study drug, and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analyses.||score on a scale||Standard Error|Least Squares Mean
688308|NCT01467700|Secondary|Clinical Global Impression Scale-Improvement (CGI-I) Score at Week 6|"The CGI-I assesses the clinician's impression of the participant's state of mental illness improvement and consists of one question for the investigator: Compared to his condition at the start of the study, how much has this patient changed? which is rated on a seven-point scale (1=very much improved; 2=much improved; 3=minimally improved; 4=no change relative to baseline; 5=minimally worse; 6= much worse; 7=very much worse). Higher scores indicate greater severity of illness. A MMRM model was used for analysis with baseline*week, pooled center, week, treatment, baseline, and week*treatment as factors in the analysis."|6 Weeks|Participants from FAS, all randomized participants who, received at least 1 dose of study drug, and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analyses.||score on a scale||Standard Error|Least Squares Mean
688366|NCT01467479|Secondary|Percentage of Participants With Extended Rapid Viral Response (eRVR)|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. eRVR was defined as undetectable HCV RNA (<lower limit of quantification) at both 4 weeks and 12 weeks after the start of study treatment.|Week 4 and Week 12|Safety set. Here, n = participants evaluable for specified category for each arm, respectively.||percentage of participants|||Number
688309|NCT01467700|Secondary|Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Week 6|The YMRS total score at week 6 relative to baseline. YMRS is a four item scale to assess manic symptoms, rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe), with 7 items rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe) with higher scores reflecting greater levels of mania. The YMRS total score is calculated as the sum of the 11 individual item scores and ranges from 0-60. Higher scores indicate greater severity of symptoms. A negative change from Baseline indicates improvement. A MMRM model was used for analyses with baseline*week, pooled center, week, treatment, baseline, and week*treatment as factors in the analysis.|Baseline and Week 6|Participants from FAS, all randomized participants who, received at least 1 dose of study drug, and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analyses.||score on a scale||Standard Error|Least Squares Mean
688310|NCT01467700|Secondary|Percentage of Participants With MADRS Response at Week 6, With Response Defined as a ≥ 50% Decrease in the MADRS Total Score From Baseline|MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (i.e., apparent sadness, reported sadness, inner tension, etc.) rated on a 7-point Likert scale from 0 (normal) to 6 (most abnormal) with a total score range from 0 to 60. Higher scores indicate greater severity of symptoms.|Baseline and Week 6|Participants from FAS, all randomized participants who, received at least 1 dose of study drug, and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analyses.||percentage of participants|||Number
688311|NCT01467700|Secondary|Change From Baseline in Quality of Life, Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF) Short Form Total Score at Week 6|Q-LES-Q -SF is a self-administered, 16-item questionnaire to assess the degree of enjoyment and satisfaction experienced by participants in various areas of daily functioning, such as social relationships, living/housing, physical health, medication, and global satisfaction. The questionnaire consists of 16 items rated by the participants on a 5-point scale. Of these, 14 items are summed to produce a total quality of life score with a maximum of 70 points. In addition, there are two global items that are scored individually. These items rate satisfaction with study medication and overall life satisfaction. The questionnaire is usually scored as a percent of total possible score, with higher scores indicating better health status. A positive change from Baseline indicates improvement. A MMRM model was used for analysis with baseline*week, pooled center, week, treatment, baseline, and week*treatment as factors in the analysis.|Baseline and Week 6|Participants from FAS, all randomized participants who, received at least 1 dose of study drug, and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analyses.||percent of maximum score on a scale||Standard Error|Least Squares Mean
688312|NCT01467700|Primary|Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 6|The change between MADRS score at week 6 relative to Baseline. MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (i.e., apparent sadness, reported sadness, inner tension, etc.) rated on a 7-point Likert scale from 0 (normal) to 6 (most abnormal) with a total score range from 0 to 60. Higher scores indicate greater severity of symptoms. A negative change from Baseline indicates improvement. A mixed measures repeated measures (MMRM) model was used for analysis with baseline*week, pooled center, week, treatment, baseline, and week*treatment as factors in the analysis.|Baseline and Week 6|Participants from full analysis set (FAS), all randomized participants who, received at least 1 dose of study drug, and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analyses.||score on a scale||Standard Error|Least Squares Mean
688313|NCT01467661|Primary|Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities|Standard 12-Lead ECG analysis was performed to identify the ECG abnormalities. Clinically significant abnormalities like QT prolongation, atrial fibrillation, were decided by the investigator during the study.|From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product|Safety analysis set included all enrolled participants who had taken at least 1 dose of SPD422 since enrolment into Study SPD422-308 (NCT01214915).||participants|||Number
688314|NCT01467661|Primary|Percentage of Participants With TEAEs and TESAEs Related to Vital Signs During Post-marketing Trial|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken. Vital signs included pulse rate, systolic and diastolic blood pressure, and weight.|From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product|Post-marketing trial safety analysis set included all participants in the safety analysis set who continued into the post-marketing part of study SPD422-309 (NCT01467661).||percentage of participants|||Number
688315|NCT01467661|Primary|Percentage of Participants With TEAEs and TESAEs Related to Vital Signs|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken. Vital signs included pulse rate, systolic and diastolic blood pressure, and weight.|From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product|Safety analysis set included all enrolled participants who had taken at least 1 dose of SPD422 since enrolment into Study SPD422-308 (NCT01214915).||percentage of participants|||Number
688367|NCT01467479|Secondary|Percentage of Participants With Rapid Viral Response (RVR)|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. RVR was defined as undetectable HCV RNA (<lower limit of quantification) 4 weeks after the start of study treatment.|Week 4|Safety set. Here, n = participants evaluable for specified category for each arm, respectively.||percentage of participants|||Number
688316|NCT01467661|Primary|Percentage of Participants With TEAEs and TESAEs Related to Clinical Laboratory Result During Post-marketing Trial|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken. Clinical Laboratory analysis included hematology, biochemistry, and urinalysis.|From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product|Post-marketing trial safety analysis set included all participants in the safety analysis set who continued into the post-marketing part of study SPD422-309 (NCT01467661).||percentage of participants|||Number
688317|NCT01467661|Primary|Percentage of Participants With TEAEs and TESAEs Related to Clinical Laboratory Result|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken. Clinical Laboratory analysis included hematology, biochemistry, and urinalysis.|From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product|Safety analysis set included all enrolled participants who had taken at least 1 dose of SPD422 since enrolment into Study SPD422-308 (NCT01214915).||percentage of participants|||Number
688318|NCT01467661|Primary|Percentage of Participants With TEAEs and TESAEs During Post-marketing Trial|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken.|From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product|Post-marketing trial safety analysis set included all participants in the safety analysis set who continued into the post-marketing part of study SPD422-309 (NCT01467661).||percentage of participants|||Number
688319|NCT01467661|Primary|Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken.|From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product|Safety analysis set included all enrolled participants who had taken at least 1 dose of SPD422 since enrolment into Study SPD422-308 (NCT01214915).||percentage of participants|||Number
688320|NCT01467661|Primary|Percentage of Participants Who Achieved Shift From Baseline in Platelet Count During Post-marketing Trial|Baseline considered from study SPD422-308 (NCT01214915). Final assessment (FA) was defined as the last non-missing data (End of study visit in SPD422-309 [NCT01467661], or early termination visit either in SPD422-308 [NCT01214915] or SPD422-309 [NCT01467661], or last available study visit). Participants who had platelet count <600 x 10^9 platelet per liter and greater than equal (>=) 600 x 10^9 platelet per liter at the final assessment as a shift from baseline during the post marketing trial was reported. Percentage of participants with shift = number of participants with shift / post-marketing safety analysis set (33 participants) * 100.|Baseline and final assessment (within 5 days of the last dose of investigational product)|Post-marketing trial safety analysis set included all participants in the safety analysis set who continued into the post-marketing part of study SPD422-309 (NCT01467661). Here, n = number for participants evaluable at the specific category.||percentage of participants|||Number
688321|NCT01467661|Primary|Percentage of Participants Who Achieved Shift From Baseline in Platelet Count|Baseline considered from study SPD422-308 (NCT01214915). Final assessment (FA) was defined as the last non-missing data (End of study visit in SPD422-309 [NCT01467661], or early termination visit either in SPD422-308 [NCT01214915] or SPD422-309 [NCT01467661], or last available study visit). Participants who had platelet count <600 x 10^9 platelet per liter and greater than equal (>=) 600 x 10^9 platelet per liter at the final assessment as a shift from baseline was reported. Percentage of participants with shift = number of participants with shift / Safety analysis set (53 participants) * 100.|Baseline and final assessment (within 5 days of the last dose of investigational product)|Safety analysis set included all enrolled participants who had taken at least 1 dose of SPD422 since enrolment into Study SPD422-308 (NCT01214915). Here, n = number for participants evaluable at the specific category.||percentage of participants|||Number
688322|NCT01467661|Primary|Percentage of Participants Who Achieved Platelet Count Less Than (<) 600 During Post-marketing Trial|Baseline considered from study SPD422-308 (NCT01214915). Final assessment was defined as the last non-missing data (End of study visit in SPD422-309 [NCT01467661], or early termination visit either in SPD422-308 [NCT01214915] or SPD422-309 [NCT01467661], or last available study visit). Participants who achieved platelet count <600 x 10^9 platelets per liter during the post-marketing trial were reported.|Baseline and final assessment (within 5 days of the last dose of investigational product)|Post-marketing trial safety analysis set included all participants in the safety analysis set who continued into the post-marketing part of study SPD422-309 (NCT01467661). Here, n = number of participants analysed at specific time point.||percentage of participants|||Number
688323|NCT01467661|Primary|Percentage of Participants Who Achieved Platelet Count Less Than (<) 600|Baseline considered from study SPD422-308 (NCT01214915). Final assessment was defined as the last non-missing data (End of study visit in SPD422-309 [NCT01467661], or early termination visit either in SPD422-308 [NCT01214915] or SPD422-309 [NCT01467661], or last available study visit). Participants who achieved platelet count <600 x 10^9 platelets per liter at each visit were reported.|Baseline, Week 1, Month 1-12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, and final assessment (within 5 days of the last dose of investigational product)|Safety analysis set included all enrolled participants who had taken at least 1 dose of SPD422 since enrolment into Study SPD422-308 (NCT01214915). Here, n = number of participants analysed at specific time point.||percentage of participants|||Number
688324|NCT01467661|Primary|Change From Baseline in Platelet Count During Post-marketing Trial at Final Assessment|Baseline considered from study SPD422-308 (NCT01214915). Final assessment was defined as the last non-missing data (End of study visit in SPD422-309 [NCT01467661], or early termination visit either in SPD422-308 [NCT01214915] or SPD422-309 [NCT01467661], or last available study visit).|Baseline and final assessment (within 5 days of the last dose of investigational product)|Post-marketing trial safety analysis set included all participants in the safety analysis set who continued into the post-marketing part of study SPD422-309 (NCT01467661). Here, n = number of participants analysed at specific time point.||10^9 platelets per liter (10^9/L)||Standard Deviation|Mean
688325|NCT01467661|Primary|Change From Baseline in Platelet Count at Final Assessment|Baseline considered from study SPD422-308 (NCT01214915). Final assessment was defined as the last non-missing data (End of study visit in SPD422-309 [NCT01467661], or early termination visit either in SPD422-308 [NCT01214915] or SPD422-309 [NCT01467661], or last available study visit).|Baseline and final assessment (within 5 days of the last dose of investigational product)|Safety analysis set included all enrolled participants who had taken at least 1 dose of SPD422 since enrolment into Study SPD422-308 (NCT01214915).||10^9 platelets per liter (10^9/L)||Standard Deviation|Mean
688326|NCT01467583|Secondary|To Determine Number of Participants Who Experienced a Bleeding Event, Either Major or Minor, and to Determine the Number of Participants Who Experienced a Venous Thromboembolism During the Study Period|Safety will be assessed through monitoring for clinical signs of bleeding. Major and minor bleeding will be documented. In additions, venous doppler studies of the bilateral lower extremities will be performed at study entry and study completion to monitor for any evidence of venous thromboembolism during the study period. We will report on the number of participants experiencing an adverse event during the study|2 years|||participants|||Number
688327|NCT01467583|Primary|To Determine if an Adjusted-dose of Fondaparinux 2.5 mg Subcutaneously (SQ) q48 hr in Critically Ill Patients With Renal Failure Will Achieve Peak and Trough Levels Similar to Patients With Normal Renal Function on 2.5 mg SQ Daily Dosing of Fondaparinux.|Fondaparinux Peak Levels measured at time +3 hours after the dose, and Trough Levels, measured at time + 47 hours post-dose around the first 5 doses of fondaparinux and then every 3rd dose thereafter. Levels will be sent to our hospital laboratory and performed using a calibrated fondaparinux assay.|2 years|||mcg/ml||Standard Deviation|Mean
688328|NCT01467570|Secondary|ORS Intake at 4 h|% of prescribed ORS that was consumed during first 4 hours|4 hrs|||percentage of prescribed ORS||Standard Deviation|Mean
688329|NCT01467570|Secondary|Adverse Events|any adverse event, providing a description if related or not related to study intervention|24 hours|||participants|||Number
688330|NCT01467570|Secondary|Hospitalization|need for hospitalization within a week|1 week|||participants|||Number
688331|NCT01467570|Secondary|Return Visit to the Emergency Department|Return visit to the emergency department within a week|1 week|||participants|||Number
688332|NCT01467570|Secondary|Duration of Diarrhea (Hrs)|Time of diarrhea in hours|7days|||hrs||Standard Deviation|Mean
688333|NCT01467570|Secondary|Weight Gain in Gram|Weight gain in gram (in the first 24 hours, and total)|24 hours|||gram||Standard Deviation|Mean
688334|NCT01467570|Secondary|ORS Intake in ml|ORS intake in ml (in the first 24 hours, and total)|24 hours|||ml||Standard Deviation|Mean
688335|NCT01467570|Secondary|Vomiting|Vomiting starting or progressing in the first 24 hours of therapy|24 hours|||participants|||Number
688336|NCT01467570|Secondary|Unscheduled Intravenous Therapy|Need for intravenous therapy within 24 hours|24 hours|||participants|||Number
688337|NCT01467570|Primary|Number of Participants That Were Successfully Rehydrated|"The following components are included in primary outcome:
resolution of signs of dehydration
adequate weight gain
production of urine output during the trial"|Proportion of successfully rehydrated at 24 hours|||Participants|||Number
688338|NCT01467557|Secondary|Change in 8-item Contact Lens Dry Eye Questionnaire Score From Baseline to 2 Week, 4 Month and 12 Month Surveys|The response set for each question was a 5-level likert scale. Intensity of discomfort, dryness, blurriness were measured with the likert scale from 0(Never Have It) to 5(Very Intense). Frequency of discomfort, dryness, blurry vision, removal of lenses, and eye closure(how often you wanted to close them) were measured with the likert scale from 1(Never) to 5(Constantly). The sum of all responses was recorded for each subject and then the average sum for all subjects was reported. The average can range from 0- 40 (continuous).|Baseline, 2 Week, 4 Month or 12 Month surveys|The analysis population consists of all subjects that were considered to be experienced contact lens wearers. Subjects were considered to be experienced contact lens wearers if subjects were assigned daily disposable lens at all evaluation points.||units on a scale||Standard Deviation|Mean
688339|NCT01467557|Primary|Incidence of Adverse Events|Adverse events were reported by subjects via the electronic surveys if they responded “yes” to the question “Since we last contacted you, have you experienced a red or painful eye that required a visit to an eye doctor or emergency room?”. Consensus diagnosis was made after review of clinical records by Adjudication Panel.|Self-report at 2 Week, 4 Month or 12 Month surveys|The analysis population consisted of subjects that were enrolled into this study. (i.e subjects that met all study eligibility criteria)||participants|||Number
688340|NCT01467505|Other Pre-specified|Percentage of Participants With Sustained Viral Response 4 Weeks After Last Planned Dose of Study Drug (SVR4)||4 weeks after last planned dose of study drug (up to Week 52)|Due to early study termination as part of a decision to modify the drug development plan the data for this outcome measure was not collected, as planned.|||||
688922|NCT01461473|Secondary|Nocturnal Mean Arterial Blood Pressure (NMAP) at 6 Months|Nocturnal mean arterial blood pressure as recorded by 24-hour ambulatory blood pressure monitoring after approximately 6 months of treatment|6 months|||mmHg||Standard Deviation|Mean
688341|NCT01467505|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|"Any adverse change from the participant's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Study drug includes all investigational agents (including placebo, if applicable) administered during the course of the study."|Baseline up to Week 52|Safety Set included all participants who received at least 1 dose of study drug.||participants|||Number
688342|NCT01467505|Secondary|Number of Participants With Telaprevir Resistant HCV Variant at Non-Structural Viral Protein 3-4A (NS3-4A) Region||48 weeks|Due to early study termination as part of a decision to modify the drug development plan the data for this outcome measure was not collected, as planned.|||||
688343|NCT01467505|Secondary|Percentage of Participants With Histological Evidence of Stabilization or Improvement in Inflammation Grade or Fibrosis Stage||48 weeks|Due to early study termination as part of a decision to modify the drug development plan the data for this outcome measure was not collected, as planned.|||||
688344|NCT01467505|Secondary|Percentage of Participants With Biopsy Confirmed and Treated Rejection||48 weeks|Due to early study termination as part of a decision to modify the drug development plan the data for this outcome measure was not collected, as planned.|||||
688345|NCT01467505|Secondary|Percentage of Participants Requiring Dose Titration of Immunosuppressant Medications||48 weeks|Due to early study termination as part of a decision to modify the drug development plan the data for this outcome measure was not collected, as planned.|||||
688346|NCT01467505|Secondary|Pharmacokinetics of Telaprevir, Peg-IFN, RBV , and Selected Immunosuppressant Medications (Tacrolimus and Cyclosporine)||48 weeks|Due to early study termination as part of a decision to modify the drug development plan the data for this outcome measure was not collected, as planned.|||||
688347|NCT01467505|Secondary|Percentage of Participants With Viral Relapse||48 weeks|Due to early study termination as part of a decision to modify the drug development plan the data for this outcome measure was not collected, as planned.|||||
688348|NCT01467505|Secondary|Percentage of Participants With On-Treatment Virologic Failure|On-treatment virologic failure was defined as subjects who met futility or who completed the assigned treatment duration and had detectable HCV RNA at planned end of treatment (up to 48 weeks). Data for this outcome was not planned to be reported by prior response.|Baseline up to Week 48|Safety Set included all participants who received at least 1 dose of study drug.||percentage of participants|||Number
688349|NCT01467505|Secondary|Percentage of Participants With Extended Rapid Viral Response (eRVR)|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. eRVR was defined as undetectable HCV RNA at both 4 weeks and 12 weeks after the start of study treatment.|Week 4 and Week 12|Safety Set included all participants who received at least 1 dose of study drug. Here, n = participants evaluable for specified category for each arm, respectively.||percentage of participants|||Number
688350|NCT01467505|Secondary|Percentage of Participants With Rapid Viral Response (RVR)|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. RVR was defined as undetectable HCV RNA 4 weeks after the start of study treatment.|Week 4|Safety Set included all participants who received at least 1 dose of study drug. Here, n = participants evaluable for specified category for each arm, respectively.||percentage of participants|||Number
688351|NCT01467505|Secondary|Percentage of Participants With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR24)|SVR24 was defined as an undetectable HCV RNA Levels at 24 weeks after last planned dose of study treatment. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL.|24 weeks after last planned dose of study drug (up to Week 72)|Safety Set included all participants who received at least 1 dose of study drug. Here, number of participants analyzed = participants evaluable for this measure and n = participants evaluable for specified category for each arm, respectively.||percentage of participants|||Number
688352|NCT01467505|Primary|Percentage of Participants With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12)|SVR12 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (<lower limit of quantification) at 12 weeks after last planned dose of study treatment. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL).|12 weeks after last planned dose of study drug (up to Week 60)|Safety Set included all participants who received at least 1 dose of study drug. Here, n = participants evaluable for specified category for each arm, respectively.||percentage of participants|||Number
688353|NCT01467492|Other Pre-specified|Plasma Concentration of Telaprevir, Peginterferon Alfa-2a (Peg-IFN) and Ribavirin (RBV)||48 weeks|Pharmacokinetic sampling was not performed as per changes in planned analysis (protocol amendment); hence no data was collected.|||||
688354|NCT01467492|Secondary|Number of Participants With Telaprevir Resistant HCV Variant at Non-Structural Viral Protein 3-4A (NS3-4A) Region|Sequence analysis of the HCV NS3-4A region was performed to monitor telaprevir-resistant variants. HCV RNA was isolated from the plasma, amplified by reverse transcription-polymerase chain reaction (RT-PCR), and sequenced (sequencing assay limit of detection HCV RNA >=1000 IU/mL). Results of this outcome measure were to be reported for overall participants instead of by race and by prior response.|up to Week 72|FA Set.||participants|||Number
688368|NCT01467479|Secondary|Percentage of Participants With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR 24)|SVR 24 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (<lower limit of quantification) at 24 weeks after last planned dose of study drug. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL).|24 weeks after last planned dose of study drug (up to Week 72)|Safety set. Here number of participants analyzed = participants evaluable for this measure and n = participants evaluable for specified categories, for each arm, respectively.||percentage of participants|||Number
688355|NCT01467492|Secondary|Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. AE includes SAE as well as Non-SAEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event.|Up to Week 52|Safety Set.||percentage of participants|||Number
688356|NCT01467492|Secondary|Percentage of Participants With On Treatment Virologic Failure|On treatment virologic failure was defined as meeting any futility rule or completing assigned treatment duration and having detectable HCV RNA at EOT. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. Futility rules: 1) Virologic breakthrough (at least 1 log10 increase from nadir or confirmed detectable HCV RNA after undetectable HCV RNA) from Day 1 through Week 24 or 48 (depending on treatment duration); 2) HCV RNA >1000 IU/mL during Weeks 4 to 12, inclusive; 3) Detectable HCV RNA after Week 12. Percentages are calculated by using total number in FA set as denominator, in each category.|Week 2, 4, 8, 12, 16, 24, 28, 36, 40, and 48|FA Set.||percentage of participants|||Number
688357|NCT01467492|Secondary|Percentage of Participants With Virologic Breakthrough|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. Virologic breakthrough on treatment was defined as an increase of at least 1 log10 from nadir or confirmed detectable HCV RNA (>=lower limit of quantification) after undetectable HCV RNA (<lower limit of quantification). Percentages are calculated by using total number in FA set as denominator, in each category.|Week 2, 4, 8, and 12|FA Set.||percentage of participants|||Number
688358|NCT01467492|Secondary|Percentage of Participants With Relapse|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. Relapse was defined as having undetectable HCV RNA (<lower limit of quantification) at actual end of treatment (EOT) and followed by detectable HCV RNA (>=lower limit of quantification) during follow-up.|4 weeks (Wk) (up to Week 52), 12 weeks (up to Week 60) and 24 weeks (up to Week 72) after actual EOT|FA Set. Here number of participants analyzed signifies participants with undetectable HCV RNA (HCV RNA <lower limit of quantification) at actual EOT and n signifies participants with undetectable HCV RNA at actual EOT for specified category.||percentage of participants|||Number
688359|NCT01467492|Secondary|Percentage of Participants With Extended Rapid Viral Response (eRVR)|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. eRVR was defined as undetectable HCV RNA (<lower limit of quantification) at both 4 weeks and 12 weeks after the start of study treatment.|Week 4 and Week 12|FA Set. Here, n signifies participants who were evaluable for specified category for each arm, respectively.||percentage of participants|||Number
688360|NCT01467492|Secondary|Percentage of Participants With Sustained Viral Response 24 Weeks After Last Actual Dose of Study Drug (SVR24)|SVR24 was defined as an undetectable HCV RNA Levels (<lower limit of quantification) at 24 weeks after last actual dose of study drug. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL.|24 weeks after last actual dose of study drug (up to Week 72)|FA Set. Here, n signifies participants who were evaluable for specified category for each arm, respectively.||percentage of participants|||Number
688361|NCT01467492|Primary|Percentage of Participants With Sustained Viral Response 12 Weeks After Last Actual Dose of Study Drug (SVR12)|SVR12 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (<lower limit of quantification) at 12 weeks after last actual dose of study drug. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL).|12 weeks after last actual dose of study drug (up to Week 60)|FA Set. Here, n signifies participants who were evaluable for specified category for each arm, respectively.||percentage of participants|||Number
688362|NCT01467479|Secondary|Number of Participants With Telaprevir Resistant HCV Variant at Non-Structural Viral Protein 3-4A (NS3-4A) Region|Sequence analysis of the HCV NS3-4A region was performed to monitor telaprevir-resistant variants. HCV RNA was isolated from the plasma, amplified by reverse transcription-polymerase chain reaction (RT-PCR), and sequenced (sequencing assay limit of detection HCV RNA >=1000 IU/mL). Results of this outcome measure were to be reported for overall participants instead of by HAART treatment.|Baseline, follow-up (Week 96)|Full analysis set. Here number of participants analyzed = participants who were evaluable for this measure and n = participants evaluable for specified categories.||participants|||Number
688363|NCT01467479|Secondary|Maximum (Cmax), Minimum (Cmin), and Average Plasma Concentration (Cavg)|Cmax, Cmin, and Cavg were reported for atazanavir (ATV), efavirenz (EFV), raltegravir (RAL), and telaprevir.|Day -14 to Day -1 and Week 1 for ATV, EFV, and RAL; Week 1 for telaprevir|Full Analysis set.Here, n = participants evaluable for specified category for each arm, respectively.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
688364|NCT01467479|Secondary|Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event.|Up to Week 52|Safety set.||percentage of participants|||Number
688365|NCT01467479|Secondary|Percentage of Participants With Undetectable HCV RNA at End of Treatment (EOT)|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. Percentage of participants with undetectable HCV RNA (<lower limit of quantification) at EOT (up to Week 48) are reported. Data for this outcome was not planned to be reported by prior response.|EOT (up to Week 48)|Full analysis set included all participants who received at least 1 dose of study drug.||percentage of participants|||Number
688982|NCT01460732|Primary|Asleep Systolic Home Blood Pressure Measurement|Home Blood Pressure measurement device was applied by the patient himself, in order to perform BP measurements during sleep, as per protocol.|2 weeks|||mmHg||Standard Deviation|Mean
688369|NCT01467479|Primary|Percentage of Participants With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12)|SVR 12 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (<lower limit of quantification) at 12 weeks after last planned dose of study drug. The plasma hepatitis C virus ribonucleic acid (HCV RNA) level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL).|12 weeks after last planned dose of study drug (up to Week 60)|Safety Set included all participants who received at least 1 dose of study drug. Here, n = participants evaluable for specified category for each arm, respectively.||percentage of participants|||Number
688370|NCT01467076|Secondary|Length of Hospital Stay||Up to one year||||||
688371|NCT01467076|Secondary|Number of Days of Oxygen (O2) Used, and Need for Supplemental Oxygen (O2)||28 Days of LIfe||||||
688372|NCT01467076|Secondary|Duration of Mechanical Ventilation||Until death or hospital discharge, up to on year||||||
688373|NCT01467076|Secondary|Need for Extracorporeal Membrane Oxygenation (ECMO)||Until death or hospital discharge, up to one year||||||
688374|NCT01467076|Secondary|Death||Up to one year||||||
688375|NCT01467076|Secondary|Duration of iNO Therapy||Until death or hospital discharge, up to one year||||||
688376|NCT01467076|Secondary|Need for INO 72 Hours After INO||72 hours after INO||||||
688377|NCT01467076|Secondary|Improvement in Oxygenation Index (OI)||72 Hours||||||
688378|NCT01467076|Secondary|Improvement in Partial Pressure of Oxygen in the Blood (PaO2)||72 hours||||||
688379|NCT01467076|Primary|Assess Feasibility to Recruit at Least 50 Infants|The primary outcome is the ability to recruit adequate number of infants (n=50) in a 9 month period without excessive (>20%) protocol violations.|9 months after 75% of the participating sites are enrolling|Late preterm & term infants ≤ 7 days postnatal age undergoing conventional ventilation (CNV) or high frequency oscillatory ventilation (HFOV) for NHRF (including perinatal aspiration syndrome, suspected/proven pneumonia/sepsis, respiratory distress syndrome, idiopathic PPHN or suspected pulmonary hypoplasia) with suboptimal response to INO||participants|||Number
688380|NCT01467037|Other Pre-specified|Vaccine Effectiveness of RV1|"RV1 vaccine effectiveness (VE) was investigated using a subset of active surveillance participants age-eligible to receive 2-doses of RV1 vaccine, defined as participants (i) <15 weeks of age as of program implementation (November 1, 2011), and (ii) ≥16 weeks of age at symptom onset. These ages corresponded to the maximum recommended age of administration for the first RV1 dose at program implementation, and the recommended age of second dose administration, respectively.
Only valid RV1 vaccinations administered ≥14 days prior to symptom onset were considered. RV1 VE was estimated as (1 − exposure odds ratio) × 100. Based upon our sampling scheme, the exposure odds ratio from our analyses approximates the rate ratio."|From February 1, 2012 to May 31, 2014|||adjusted VE||95% Confidence Interval|Number
688381|NCT01467037|Primary|Matched VE Participants|"RV1 vaccine effectiveness (VE) was investigated using a subset of active surveillance participants age-eligible to receive 2-doses of RV1 vaccine, defined as participants (i) <15 weeks of age as of program implementation (November 1, 2011), and (ii) ≥16 weeks of age at symptom onset. These ages corresponded to the maximum recommended age of administration for the first RV1 dose at program implementation, and the recommended age of second dose administration, respectively.
We estimated RV1 VE of 2- versus 0-doses and ≥1- versus 0-doseto prevent rotavirus hospitalization or emergency visits. Only valid RV1 vaccinations administered ≥14 days prior to symptom onset were considered. Children vaccinated with RV5 (private market,minimal penetrance) were excluded."|From February 1, 2012 to May 31, 2014|Rotavirus vaccination history by rotavirus disease status among matched VE participants||participants|||Number
688382|NCT01466881|Other Pre-specified|Aurora Kinase A Expression|To explore the association between pre-treatment aurora kinase A expression in tumor biopsies as measured by fluorescence in situ hybridization (FISH) and objective response rate in patients with PTCL treated with MLN8237|Baseline|Eligible patients who consented for correlative studies and had Aurora kinase A expression measured.||proportion of positivity||Standard Deviation|Mean
688383|NCT01466881|Secondary|To Evaluate the Safety and Tolerability of MLN8237 (Number of With Grade 3 Through Grade 5 Adverse Events That Are Related to MLN8237)|Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|Up to 1 year after registration|Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 4.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.||Participants|||Number
688384|NCT01466881|Secondary|Progression Free Survival (PFS)|Measured from date of registration to date of first observation of progressive disease or death due to any cause. Patients last known to be alive and without report of progressive disease are censored at date of last contact. Progressive disease is at least 50% increase in the sum of the product of the diameters (SPD) of target measurable nodal lesions over the smallest sum observed or ≥ 50% increase in the greatest transverse diameter (GTD) of any node > 1 cm in shortest axis, or ≥ 50% increase in the SPD of other target measurable lesions over the smallest sum observed. New bone marrow involvement. New lesion > 1.5 cm in longest axis, or ≥ 50% increase in GTD of any previously involved node with a diameter ≤ 1.0 cm in the short axis such that its longest axis is now > 1.5 cm. Lymph nodes with long axis is > 1.5 cm, or if the both the long and short axes are > 1 cm. PET should be positive if positive PET at baseline.|Up to 2 years after registration|Only eligible patients were included in the analysis||Months||95% Confidence Interval|Mean
688385|NCT01466881|Secondary|Overall Survival (OS)|Measure from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Up to 2 years after registration|Only eligible patients were included in the analysis.||Months||95% Confidence Interval|Median
688386|NCT01466881|Primary|Objective Response Rate (Complete Responses (CR) + Partial Responses (PR))|Objective disease status is evaluated according to the 2007 revised Cheson et al. criteria. Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow (BM) must be negative if positive at baseline. Normalization of markers. Partial Response(PR) is a 50% decrease in the SPD for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.|Up to 1 year after registration|All eligible patients who started treatment were included in assessing response estimates.||participants|||Number
688387|NCT01466790|Secondary|Number of Participants With Viral Relapse|Viral relapse was defined as undetectable HCV RNA at the actual EOT and confirmed quantifiable HCV RNA (>= 25 IU/mL) during follow-up period.|During the Follow-up [Week 36 (for the arms treated for 12 weeks) or Week 24 (for the arms treated for 24 weeks)]|Intention-to-treat (ITT) population included all randomized participants who took at least one dose of investigational drug.||Participants|||Number
688388|NCT01466790|Secondary|Number of Participants With Inadequate Virologic Response|Inadequate Virologic Response was defined as confirmed detectable HCV RNA at or after Week 8 and not meeting the viral breakthrough definition.|Week 8 and End of Treatment [Week 12 (for the arms treated for 12 weeks) or Week 24 (for the arms treated for 24 weeks)]|Intention-to-treat (ITT) population included all randomized participants who took at least one dose of investigational drug.||Participants|||Number
688389|NCT01466790|Secondary|Number of Participants With Viral Breakthrough|Viral breakthrough was defined as confirmed quantifiable HCV RNA after becoming less than (<) lower limit of quantification (LLOQ) or confirmed greater than (>) 1 log10 HCV RNA increase from the lowest level reached on 2 consecutive occasions.|Up to End of Treatment [Week 12 (for the arms treated for 12 weeks) or Week 24 (for the arms treated for 24 weeks)]|Intention-to-treat (ITT) population included all randomized participants who took at least one dose of investigational drug.||Participants|||Number
688390|NCT01466790|Secondary|Number of Participants With a Sustained Virologic Response (SVR) at Week 48|Participants with HCV RNA undetectable at end of treatment and HCV RNA less than (<) 25 IU/mL (detectable or undetectable) at week 48.|Week 48|Intention-to-treat (ITT) population included all randomized participants who took at least one dose of investigational drug.||Participants|||Number
688391|NCT01466790|Secondary|Number of Participants With a Sustained Virologic Response (SVR) 24 Weeks After the Planned End of Treatment (EOT)|Participants with HCV RNA undetectable at end of treatment and HCV RNA less than (<) 25 IU/mL (detectable or undetectable) at 24 weeks after the planned end of treatment.|Week 12 and 36 (for the arms treated for 12 weeks) or Week 24 and 48 (for the arms treated for 24 weeks)|Intention-to-treat (ITT) population included all randomized participants who took at least one dose of investigational drug.||Participants|||Number
688392|NCT01466790|Secondary|Number of Participants With a Sustained Virologic Response (SVR) 4 Weeks After the Planned End of Treatment (EOT)|Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) undetectable at end of treatment and HCV RNA less than (<) 25 international unit per milliliter (IU/mL) (detectable or undetectable) at 4 weeks after the planned end of treatment.|Week 12 and 16 (for the arms treated for 12 weeks) or Week 24 and 28 (for the arms treated for 24 weeks)|Intention-to-treat (ITT) population included all randomized participants who took at least one dose of investigational drug.||Participants|||Number
688393|NCT01466790|Primary|Number of Participants With a Sustained Virologic Response (SVR) 12 Weeks After the Planned End of Treatment (EOT)|Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) undetectable at end of treatment and HCV RNA less than (<) 25 international unit per milliliter (IU/mL) (detectable or undetectable) at 12 weeks after the planned end of treatment.|Week 12 and 24 (for the arms treated for 12 weeks) or Week 24 and 36 (for the arms treated for 24 weeks)|Intention-to-treat (ITT) population included all randomized participants who took at least one dose of investigational drug.||Participants|||Number
688394|NCT01466764|Secondary|Total Length of Hospital Stay|Total length of hospital stay for patients enrolled in the study.|Up to approximately 5 days maximum (admittance to discharge)|||hours||Standard Deviation|Median
688395|NCT01466764|Secondary|Assess Rates of Wound Dehiscence|Evaluation of the surgical wound for symptoms of wound dehiscence was made every day during hospitalization. Records from the first post-operative clinic visit were also evaluated for evidence of wound dehiscence.|Up to 72 hours following surgery plus 3 weeks follow-up|||Participants|||Count of Participants
688396|NCT01466764|Secondary|Count of Participants With Venous Thrombosis After Surgery During Hospitalization|Evaluation of the surgical wound for symptoms of venous thrombosis was made every day during hospitalization. Records from the first post-operative clinic visit were also evaluated for evidence of venous thrombosis.|Up to 72 hours following surgery plus 3 weeks follow-up|||Participants|||Count of Participants
688397|NCT01466764|Secondary|Count of Participants Experiencing Wound Infection in the Study From Surgery Till the Time of Discharge From the Hospital|Evaluation of the surgical wound for symptoms of wound infection was made every day during hospitalization. Records from the first post-operative clinic visit were also evaluated for evidence of wound infection.|Up to 72 hours following surgery plus 3 weeks follow-up|||Participants|||Count of Participants
688398|NCT01466764|Secondary|Post-operative Pain Intensity|Pain was measured on Day 1 and day 2 following surgery using a VAS scale at rest and on stimulation with Visual Analog Scale (VAS) of 1-10 (1=no pain and 10=worst pain)|Up to 72 hours following surgery|Participants with available data were analyzed.||units on a Visual Analog scale||Full Range|Mean
688399|NCT01466764|Secondary|Number of Participants With Analgesic Consumption During the 72 Hours Following Surgery|"Analgesic consumption is reported as the count of participants receiving each analgesic type. Comparisons between the placebo and active drug groups were made at the conclusion of the study.
PCA/IV: Patient controlled Analgesia/ Intravenous"|Up to 72 hours following surgery|||Participants|||Count of Participants
688400|NCT01466764|Primary|Concentration Levels of Inflammatory Mediators IL-1 Receptor Antagonist (IL-1ra) Present in Human Wounds Following Surgery With and Without the Use of Anakinra.|Tissue samples were collected at the surgical wound site at 3 time points during the 1st 72 hours following surgery. Tissue samples from subjects receiving placebo, and subjects receiving anakinra injections pre, and post op were analyzed for IL-1|Up to 72 hours following surgery|IL-1ra measurements were invalid due to cross-reaction with the assay platform.|||||
688401|NCT01466673|Secondary|Change From Baseline in Body Weight at Month 6|Change from Baseline in body weight is the value at Month 6 minus value at Baseline.|Baseline and Month 6|"Safety population included all randomized participants who received at least one dose of study medication. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."||Kilograms||Standard Deviation|Mean
688402|NCT01466673|Secondary|Change From Baseline in Blood Pressure (BP) at Month 6|Blood pressure is the pressure of blood flowing through blood vessels. Change from Baseline in blood pressure is the value at Month 6 minus value at Baseline.|Baseline and Month 6|"Safety population included all randomized participants who received at least one dose of study medication. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."||Millimeters of Mercury||Standard Deviation|Mean
688403|NCT01466673|Secondary|Number of Participants With Treatment Response at the End-of-Therapy by Participant’s Self-Assessment at Month 6|Participant’s self-assessment at end-of-therapy was measured by using the self-assessment questionnaire which included 3 questions, about the rating of acne improvement since start of study; comparison of this acne treatment with the one used in past and the continuity of treatment on physician’s prescription to evaluate efficacy and acceptability of the study medication. The score was graded at 4 parameters as excellent, better, no change and worse.|Month 6|"ITT population included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria. N signifies those participants who were evaluated for this measure."||Participants|||Number
688404|NCT01466673|Secondary|Percentage of Participants Showing Treatment Response on the Investigator’s Global Assessment at Month 6|Percentage of participants showing treatment response on the Investigator’s global assessment was graded on a 5-point scale as 0=worse, 1=no change, 2=fair, 3=good, and 4=excellent.|Month 6|"ITT population included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria. N signifies those participants who were evaluated for this measure."||Percentage of participants|||Number
688405|NCT01466673|Secondary|Percentage of Participants With Categorical Score for Sebum Assessment at Month 1, 3 and 6|Sebum assessment that is facial seborrhea (very oily skin) was assessed using sebutape strip on the forehead. Percentage of participants with facial seborrhea were assessed using categorical scores ranging from level 1 (lowest) to level 5 (highest). Highest level indicates worsening.|Baseline and Month 1, 3 and 6|"ITT population included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."||Percentage of Participants|||Number
688406|NCT01466673|Secondary|Number of Participants Non-Compliant With Therapy|Compliance was assessed by transforming the data of forgotten tablets listed in the diary cards. Number of participants who forgot to take the drug was reported.|Month 1, 3 and 6|"ITT population included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."||Participants|||Number
688407|NCT01466673|Secondary|Number of Participants With Abnormal Vaginal Blood Loss at Month 1, 3 and 6|Vaginal blood loss encompasses spotting and bleeding. Spotting is defined as a bleeding requiring no or at most one sanitary pad per day; however, bleeding requires two or more sanitary pads per day.|Month 1, 3 and 6|"Safety population included all randomized participants who received at least one dose of study medication. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."||Participants|||Number
688408|NCT01466673|Primary|Change From Baseline in Total and Each Type of Acne Lesions Count at Month 6|Total acne (pimples) lesion (abnormal area of tissue, such as a wound, sore, rash, or boil) count is summation of all lesions which includes all comedones (open and closed), papules, pustules, and nodules. Change from Baseline means lesions at Baseline minus lesions at Month 6. Positive value indicates decrease in lesion count while negative value indicates increase in lesion count.|Baseline and Month 6|"ITT population included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."||Lesions||Standard Deviation|Mean
688409|NCT01466673|Primary|Change From Baseline in Total and Each Type of Acne Lesions Count at Month 3|Total acne (pimples) lesion (abnormal area of tissue, such as a wound, sore, rash, or boil) count is summation of all lesions which includes all comedones (open and closed), papules, pustules, and nodules. Change from Baseline means lesions at Baseline minus lesions at Month 3. Positive value indicates decrease in lesion count while negative value indicates increase in lesion count.|Baseline and Month 3|"ITT population included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."||Lesions||Standard Deviation|Mean
688410|NCT01466673|Primary|Change From Baseline in Total and Each Type of Acne Lesions Count at Month 1|Total acne (pimples) lesion (abnormal area of tissue, such as a wound, sore, rash, or boil) count is summation of all lesions which includes all comedones (open and closed), papules, pustules, and nodules. Change from Baseline means lesions at Baseline minus lesions at Month 1. Positive value indicates decrease in lesion count while negative value indicates increase in lesion count.|Baseline and Month 1|Intent-to-treat population (ITT) included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria.||Lesions||Standard Deviation|Mean
688411|NCT01466660|Secondary|Health-related Quality of Life|"Health-related quality of life (HRQoL) measured using European Quality of life - 5 Dimensions (EQ-5D) score for United Kingdom (UK) and Belgium and European European Quality Visual Analogue Scale (EQ-VAS).
EQ-5D utility scores range from 0 (worst health) to 1 (full health).
EQ-VAS scores range from 0 (worst imaginable health state) to 100 (best imaginable health state).
Results display the mean score up to 56 weeks."|Every 8 weeks, up to 56 weeks|Randomised set including patients with available HRQoL data||Units on a scale||95% Confidence Interval|Least Squares Mean
688412|NCT01466660|Secondary|Tumour Shrinkage|Tumour shrinkage assessed by minimum sum of post-baseline target lesion diameters recorded after randomisation. A positive value shows a decrease in tumour size.|From first drug administration until last drug administration, up to 1293 days|Randomised set including patients with tumour assessments||millimetre (mm)||95% Confidence Interval|Least Squares Mean
688413|NCT01466660|Secondary|Duration of Disease Control|Duration of disease control was measured from randomisation to the time of progressive disease (PD) or death, whichever occurred first (or date of censoring for progression free survival (PFS))|From first drug administration until last drug administration, up to 1293 days|Randomised set including patients with disease control||Months||95% Confidence Interval|Median
688414|NCT01466660|Secondary|Disease Control|Disease control which was defined as objective response (complete response or partial response) or stable disease (SD).|From first drug administration until last drug administration, up to 1293 days|Randomised set||Percentage of participants||95% Confidence Interval|Number
709935|NCT00140244|Secondary|Insulin Resistance (as Assessed by HOMA-IR)||At the end of each two month intervention|||units on a scale||Standard Error|Mean
688415|NCT01466660|Secondary|Duration of Objective Response|Duration of objective response defined as the time of first objective response to the time of progression or death, whichever occurred first (or date of censoring for progression free survival (PFS))|From first drug administration until last drug administration, up to 1293 days|Randomised set including patients with objective response||Months||95% Confidence Interval|Median
688416|NCT01466660|Secondary|Time to Objective Response|"Number of participants with objective response over time, cumulative number of participants is displayed.
Time to objective response was defined as the time from randomisation to the first recorded objective response."|From first drug administration until last drug administration, up to 1293 days|Randomised set including patients with objective response||Participants|||Number
688417|NCT01466660|Secondary|Objective Response Rate|Objective response rate (ORR) which was defined as the number of participants with complete response (CR) or partial response (PR) as assessed by central independent review according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. divided by the total number of participants who received treatment. Per RECIST v1.1. for target lesions and assessed by CT-scan or Magnetic Resonance Imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions from baseline; Overall Response (OR) = CR + PR|From first drug administration until last drug administration, up to 1293 days|Randomised set||Percentage of participants||95% Confidence Interval|Number
688418|NCT01466660|Primary|Overall Survival|Overall survival (OS) which was defined as the time from the date of randomisation to the date of death.|From first drug administration until last drug administration, up to 1482 days|Randomised set||Months||95% Confidence Interval|Median
688419|NCT01466660|Primary|Time to Treatment Failure (TTF)|Time to Treatment Failure (TTF) which was the time from the date of randomisation to the date of i.e. permanent treatment discontinuation for any reason.|From first drug administration until last drug administration, up to 1293 days|Randomised set||Months||95% Confidence Interval|Median
688420|NCT01466660|Primary|Progression-free Survival|Progression-free survival (PFS) defined as the time from the date of randomisation to the date of disease progression, or to date of death if a patient died earlier. Disease progression was primarily evaluated by an independent central imaging review according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1.|From first drug administration until last drug administration, up to 1293 days|Randomised set||Months||95% Confidence Interval|Median
688421|NCT01466595|Secondary|Primary Adverse Events|Primary adverse events include all SAEs, defined according to ICH guidelines and targeted protocol events (grade 2 or higher signs and symptoms, grade 2 or higher laboratory abnormality, all diagnoses identified by the ACTG criteria for clinical events, and all events that led to a change in treatment regardless of grade).|from study enrollment until study completion at 12 weeks|||participants|||Number
688422|NCT01466595|Secondary|Change in CD4 Count From Week 4 to Week 12|Change in total CD4 T-cell count from week 4 to week 12|At weeks 4 and 12|This analysis is as-treated, limited to subjects who have data for week 4 and week 12, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 12.||cells/mm3||Inter-Quartile Range|Median
688423|NCT01466595|Secondary|Change in CD38+ of CD8+ MFI From Week 4 to Week 12|"Change in CD38+ of CD8+ median fluorescence intensity (MFI) from week 4 to week 12.
MFI measures the shift in fluorescence intensity of a population of cells. MFI values are based on control to demonstrate an increase or decrease in expression of the marker. MFI in this study was automatically calculated in FlowJo. The median is the relative intensity value below which 50% of the events are found. MFI is an arbitrary unit of relative intensity."|At weeks 4 and 12|This analysis is as-treated, limited to subjects who have data for week 4 and week 12, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 12.||MFI (relative intensity)||Inter-Quartile Range|Median
688424|NCT01466595|Secondary|Change in CD4 Activation Percent From Week 4 to Week 12|Change in CD4 activation percent co-expressing HLA-DR and CD38 from week 4 to week 12|At weeks 4 and 12|This analysis is as-treated, limited to subjects who have data for week 4 and week 12, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 12.||percentage HLA-DR+/CD38+ of CD4+||Inter-Quartile Range|Median
688425|NCT01466595|Secondary|Change in %Ki67+ of CD8+ From Week 4 to Week 12|Change in advanced flow percent Ki67+ of CD8+ from week 4 to week 12|At weeks 4 and 12|This analysis is as-treated, limited to subjects who have data for week 4 and week 12, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 12||percentage Ki67+ of CD8+||Inter-Quartile Range|Median
688426|NCT01466595|Secondary|Change in %Ki67+ of CD4+ From Week 4 to Week 12|Change in advanced flow percent Ki67+ of CD4+ from week 4 to week 12|At weeks 4 and 12|This analysis is as-treated, limited to subjects who have data for week 4 and week 12, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 12||percentage Ki67+ of CD4+||Inter-Quartile Range|Median
688427|NCT01466595|Secondary|Change in %CD38+ of CD8+ From Week 4 to Week 12|Change in advanced flow percent CD38+ of CD8+ from week 4 to week 12|At weeks 4 and 12|This analysis is as-treated, limited to subjects who have data for week 4 and week 12, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 12.||percentage CD38+ of CD8+||Inter-Quartile Range|Median
688428|NCT01466595|Secondary|Change in %CD38+ of CD4+ From Week 4 to Week 12|Change in advanced flow percent CD38+ of CD4+ from week 4 to week 12|At weeks 4 and 12|This analysis is as-treated, limited to subjects who have data for week 4 and week 12, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 12||percentage CD38+ of CD4+||Inter-Quartile Range|Median
688954|NCT01461044|Secondary|Duration of Bevacizumab as First Line Treatment||From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment)|Efficacy population.||months||Full Range|Median
688429|NCT01466595|Secondary|Change in Peripheral B7hi CD4+ T-cells From Week 4 to Week 12|Change in gut homing percent B7hi+ of CD4+ from week 4 to week 12|At weeks 4 and 12|This analysis is as-treated, limited to subjects who have data for week 4 and week 12, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 12.||percentage B7hi+ of CD4+||Inter-Quartile Range|Median
688430|NCT01466595|Secondary|Change in sCD14 From Week 4 to Week 12|Change in soluble CD14 from week 4 to week 12|At weeks 4 and 8|This analysis is as-treated, limited to subjects who have data for week 4 and week 12, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 12.||log10 ng/mL||Inter-Quartile Range|Median
688431|NCT01466595|Secondary|Change in hsCRP From Week 4 to Week 12|Change in hsCRP from week 4 to week 12.|At weeks 4 and 12|This analysis is as-treated, limited to subjects who have data for week 4 and week 12, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 12.||log10 ng/mL||Inter-Quartile Range|Median
688432|NCT01466595|Secondary|Change in LPS From Week 4 to Week 12|Change in LPS from week 4 to week 12.|At weeks 4 and 12|This analysis is as-treated, limited to subjects who have data for week 4 and week 12, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 12.||log10 pg/mL||Inter-Quartile Range|Median
688433|NCT01466595|Secondary|Change in IL-6 From Week 4 to Week 12|Change in IL-6 from week 4 to week 12.|At weeks 4 and 12|This analysis is as-treated, limited to subjects who have data for week 4 and week 12, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 12.||log10 pg/mL||Inter-Quartile Range|Median
688434|NCT01466595|Secondary|Change in D-dimer From Week 4 to Week 12|D-dimer is a fibrin degradation product (FDP), a small protein fragment present in the blood after a blood clot is degraded by fibrinolysis.|At weeks 4 and 12|This analysis is as-treated, limited to subjects who have data for week 4 and week 12, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 12.||log10 ng/mL||Inter-Quartile Range|Median
688435|NCT01466595|Secondary|Change in CD8+ T-cell Activation From Week 4 to Week 12|Change in CD8+ T-cell activation percent co-expressing HLA-DR and CD38 from week 4 to week 12|At weeks 4 and 12|This analysis is as-treated, limited to subjects who had data for both week 4 and week 12, and (for the rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 12.||percentage HLA-DR+/CD38+ of CD8+||Inter-Quartile Range|Median
688436|NCT01466595|Secondary|Change in CD4 Count From Week 4 to Week 8|Change in total CD4 T-cell count from week 4 to week 8|At weeks 4 and 8|This analysis is as-treated, limited to subjects who have data for week 4 and week 8, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 8||cells/mm3||Inter-Quartile Range|Median
688437|NCT01466595|Secondary|Change in CD38+ of CD8+ MFI From Week 4 to Week 8|"Change in CD38+ of CD8+ median fluorescence intensity (MFI) from week 4 to week 8.
MFI measures the shift in fluorescence intensity of a population of cells. MFI values are based on control to demonstrate an increase or decrease in expression of the marker. MFI in this study was automatically calculated in FlowJo. The median is the relative intensity value below which 50% of the events are found. MFI is an arbitrary unit of relative intensity."|At weeks 4 and 8|This analysis is as-treated, limited to subjects who have data for week 4 and week 8, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 8||MFI (relative intensity)||Inter-Quartile Range|Median
688438|NCT01466595|Secondary|Change in CD4 Activation Percent From Week 4 to Week 8|Change in CD4 activation percent co-expressing HLA-DR and CD38 from week 4 to week 8|At weeks 4 and 8|This analysis is as-treated, limited to subjects who have data for week 4 and week 8, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 8||percentage HLA-DR+/CD38+ of CD4+||Inter-Quartile Range|Median
688439|NCT01466595|Secondary|Change in %Ki67+ of CD8+ From Week 4 to Week 8|Change in advanced flow percent Ki67+ of CD8+ from week 4 to week 8|At weeks 4 and 8|This analysis is as-treated, limited to subjects who have data for week 4 and week 8, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 8||percentage Ki67+ of CD8+||Inter-Quartile Range|Median
688440|NCT01466595|Secondary|Change in %Ki67+ of CD4+ From Week 4 to Week 8|Change in advanced flow percent Ki67+ of CD4+ from week 4 to week 8|At weeks 4 and 8|This analysis is as-treated, limited to subjects who have data for week 4 and week 8, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 8||percentage Ki67+ of CD4+||Inter-Quartile Range|Median
688441|NCT01466595|Secondary|Change in %CD38+ of CD8+ From Week 4 to Week 8|Change in advanced flow percent CD38+ of CD8+ from week 4 to week 8|At weeks 4 and 8|This analysis is as-treated, limited to subjects who have data for week 4 and week 8, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 8||percentage CD38+ of CD8+||Inter-Quartile Range|Median
688442|NCT01466595|Secondary|Change in %CD38+ of CD4+ From Week 4 to Week 8|Change in advanced flow percent CD38+ of CD4+ from week 4 to week 8|At weeks 4 and 8|This analysis is as-treated, limited to subjects who have data for week 4 and week 8, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 8||percentage CD38+ of CD4+||Inter-Quartile Range|Median
709936|NCT00140244|Primary|Serum Lipid Levels||At the end of each two month intervention|||mg/dl||Standard Error|Mean
688443|NCT01466595|Secondary|Change in Peripheral B7hi CD4+ T-cells From Week 4 to Week 8|Change in gut homing percent B7hi+ of CD4+ from week 4 to week 8|At weeks 4 and 8|This analysis is as-treated, limited to subjects who have data for week 4 and week 8, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 8||percentage B7hi+ of CD4+||Inter-Quartile Range|Median
688444|NCT01466595|Secondary|Change in sCD14 From Week 4 to Week 8|Change in soluble CD14 from week 4 to week 8|At weeks 4 and 8|This analysis is as-treated, limited to subjects who have data for week 4 and week 8, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 8||log10 ng/mL||Inter-Quartile Range|Median
688445|NCT01466595|Secondary|Change in hsCRP From Week 4 to Week 8|Change in hsCRP from week 4 to week 8.|At weeks 4 and 8|This analysis is as-treated, limited to subjects who have data for week 4 and week 8, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 8||log10 ng/mL||Inter-Quartile Range|Median
688446|NCT01466595|Secondary|Change in LPS From Week 4 to Week 8|Change in LPS from week 4 to week 8.|At weeks 4 and 8|This analysis is as-treated, limited to subjects who have data for week 4 and week 8, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 8||log10 pg/mL||Inter-Quartile Range|Median
688447|NCT01466595|Secondary|Change in IL-6 From Week 4 to Week 8|Change in IL-6 from week 4 to week 8.|At weeks 4 and 8|This analysis is as-treated, limited to subjects who have data for week 4 and week 8, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 8||log10 pg/mL||Inter-Quartile Range|Median
688448|NCT01466595|Secondary|Change in D-dimer From Week 4 to Week 8|D-dimer is a fibrin degradation product (FDP), a small protein fragment present in the blood after a blood clot is degraded by fibrinolysis.|At weeks 4 and 8|This analysis is as-treated, limited to subjects who have data for week 4 and week 8, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 8||log10 ng/mL||Inter-Quartile Range|Median
688449|NCT01466595|Secondary|Change in CD8+ T-cell Activation From Week 4 to Week 8|Change in CD8+ T-cell activation percent co-expressing HLA-DR and CD38 from week 4 to week 8|At weeks 4 and 8|This analysis is as-treated, limited to subjects who had data for both week 4 and week 8, and (for the rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 8.||percentage HLA-DR+/CD38+ of CD8+||Inter-Quartile Range|Median
688450|NCT01466595|Secondary|Change in CD4 Count From Baseline to Week 4|Change in total CD4 T-cell from baseline to week 4, where baseline value is the average of pre-entry and entry|At baseline and 4 weeks|This analysis is as-treated, limited to subjects who have data for baseline and week 4, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure during this time period.||cells/mm3||Inter-Quartile Range|Median
688451|NCT01466595|Secondary|Change in CD38+ of CD8+ MFI From Baseline to Week 4|"Change in CD38+ of CD8+ MFI (Median Fluorescence Intensity) from baseline to week 4, where baseline value is the average of pre-entry and entry.
MFI measures the shift in fluorescence intensity of a population of cells. MFI values are based on control to demonstrate an increase or decrease in expression of the marker. MFI in this study was automatically calculated in FlowJo. The median is the relative intensity value below which 50% of the events are found. MFI is an arbitrary unit of relative intensity."|At baseline and 4 weeks|This analysis is as-treated, limited to subjects who have data for baseline and week 4, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure during this time period.||MFI (relative intensity)||Inter-Quartile Range|Median
688452|NCT01466595|Secondary|Change in %HLA-DR+/CD38+ of CD4+ From Baseline to Week 4|Change in CD4 activation percent co-expressing HLA-DR and CD38 from baseline to week 4, where baseline value is the average of pre-entry and entry|At baseline and 4 weeks|This analysis is as-treated, limited to subjects who have data for baseline and week 4, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure during this time period.||percentage HLA-DR+/CD38+ of CD4+||Inter-Quartile Range|Median
688453|NCT01466595|Secondary|Change in %Ki67+ of CD8+ From Baseline to Week 4|Change in advanced flow percent Ki67+ of CD8+ from baseline to week 4, where baseline value is the average of pre-entry and entry|At baseline and 4 weeks|This analysis is as-treated, limited to subjects who have data for baseline and week 4, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure during this time period.||percentage Ki67+ of CD8+||Inter-Quartile Range|Median
688454|NCT01466595|Secondary|Change in %Ki67+ of CD4+ From Baseline to Week 4|Change in advanced flow percent Ki67+ of CD4+ from baseline to week 4, where baseline value is the average of pre-entry and entry|At baseline and 4 weeks|This analysis is as-treated, limited to subjects who have data for baseline and week 4, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure during this time period.||percentage Ki67+ of CD4+||Inter-Quartile Range|Median
688455|NCT01466595|Secondary|Change in %CD38+ of CD8+ From Baseline to Week 4|Change in advanced flow percent CD38+ of CD8+ from baseline to week 4, where baseline value is the average of pre-entry and entry|At baseline and 4 weeks|This analysis is as-treated, limited to subjects who have data for baseline and week 4, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure during this time period.||percentage CD38+ of CD8+||Inter-Quartile Range|Median
695700|NCT01386632|Secondary|Relative Toxicities for Locally Advanced Head and Neck Squamous Cell Carcinoma Patients Receiving Concurrent Cisplatin, Radiation Therapy, and DCA.||5 years||||||
688456|NCT01466595|Secondary|Change in %CD38+ of CD4+ From Baseline to Week 4|Change in advanced flow percent CD38+ of CD4+ from baseline to week 4, where baseline value is the average of pre-entry and entry|At baseline and 4 weeks|This analysis is as-treated, limited to subjects who have data for baseline and week 4, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure during this time period.||percentage CD38+ of CD4+||Inter-Quartile Range|Median
688457|NCT01466595|Secondary|Change in Peripheral B7hi CD4+ T-cell From Baseline to Week 4|Change in gut-homing percent B7hi+ of CD4+ from baseline to week 4, where baseline value is the average of pre-entry and entry|At baseline and 4 weeks|This analysis is as-treated, limited to subjects who have data for baseline and week 4, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure during this time period.||percentage B7hi+ of CD4+||Inter-Quartile Range|Median
688458|NCT01466595|Secondary|Change in sCD14 From Baseline to Week 4|Change in soluble CD14 (sCD14) from baseline to week 4, where baseline value is the average of pre-entry and entry|At baseline and 4 weeks|This analysis is as-treated, limited to subjects who have data for baseline and week 4, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure during this time period.||log10 ng/mL||Inter-Quartile Range|Median
688459|NCT01466595|Secondary|Change in hsCRP From Baseline to Week 4|Change in High Sensitivity C-reactive Protein (Hs-CRP) from baseline to week 4, where baseline value is the average of pre-entry and entry|At baseline and 4 weeks|This analysis is as-treated, limited to subjects who have data for baseline and week 4, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure during this time period.||log10 ng/mL||Inter-Quartile Range|Median
688460|NCT01466595|Secondary|Change in LPS From Baseline to Week 4|Change in Lipopolysaccharide (LPS) from baseline to week 4, where baseline value is the average of pre-entry and entry|At baseline and 4 weeks|This analysis is as-treated, limited to subjects who have data for baseline and week 4, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure during this time period.||log10 pg/mL||Inter-Quartile Range|Median
688461|NCT01466595|Secondary|Change in IL-6 From Baseline to Week 4|Change in Interleukin (IL)-6 from baseline to week 4, where baseline value is the average of pre-entry and entry|At baseline and 4 weeks|This analysis is as-treated, limited to subjects who have data for baseline and week 4, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure during this time period.||log10 pg/mL||Inter-Quartile Range|Median
688462|NCT01466595|Secondary|Change in D-dimer From Baseline to Week 4|"Change in D-dimer from baseline to week 4, where baseline value is the average of pre-entry and entry.
D-dimer is a fibrin degradation product (FDP), a small protein fragment present in the blood after a blood clot is degraded by fibrinolysis."|At baseline and 4 weeks|This analysis is as-treated, limited to subjects who have data for baseline and week 4, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure during this time period.||log10 ng/mL||Inter-Quartile Range|Median
688463|NCT01466595|Primary|Change in CD8+ T-cell Activation From Baseline to Week 4|Change in CD8+ T-cell activation percent co-expressing HLA-DR and CD38 from baseline to week 4, where the baseline value is the average of pre-entry and entry values.|At baseline and 4 weeks|The primary analysis is as-treated, limited to subjects who had data for both baseline and week 4, and (for the rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change antiretroviral therapy (ART) or use prohibited medications or have virologic failure during this time period.||percentage HLA-DR+/CD38+ of CD8+||Inter-Quartile Range|Median
688464|NCT01466491|Secondary|Pain Scores Throughout Procedure at Various Time Points|"Distance (mm) from the left of the 100 mm Visual Analog Scale (VAS anchors: 0=none, 100 mm= worst imaginable) recorded at various points throughout procedure:
prior to medication (baseline)
after speculum insertion
with placement of PCB
with cervical dilation
with aspiration
30 minutes post-operatively"|up to several hours|||mm||Standard Error|Mean
688465|NCT01466491|Primary|Patient Perception of Pain|To determine whether varying paracervical block techniques affect patient perception of pain. Pain is measured as mm distance from the left of the 100-mm visual analogue (VAS) scale with the anchors 0 = none, 100 mm = worst imaginable (reflecting magnitude of pain) and recorded immediately after completion of cervical dilation.|At time of uterine aspiration (baseline)|||mm||Standard Deviation|Mean
688497|NCT01466270|Primary|Compliance|Compliance is the percentage of pills taken while on study (based on returned diaries)|24 weeks|Participants who returned pill diaries. Note that some participants did not return diaries so the numbers of participants for this analysis may not agree with the numbers for other analyses.||percentage of pills||Full Range|Mean
688498|NCT01466270|Primary|Retention|Retention is the percentage of participants who stay in the study for 24 weeks.|24 Weeks|All randomized patients||percentage of participants||Standard Error|Mean
688480|NCT01466361|Secondary|Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)|"AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with study treatment/s.
SAE was defined as any untoward medical occurrence that at any dose results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization results in disability/ incapacity; is a congenital anomaly/ birth defect."|Baseline, 0 minute, 60 minutes and 5 days post treatment|Safety population: All randomized participants who received the study treatments were considered evaluable for safety.||participants|||Number
688481|NCT01466361|Secondary|Percentage of Responders With Improved Craving Scores in Heavy and Light Smokers Group|Responders were defined as participants with an increase of at least one point (on the 100 point VAS scale) from baseline prior to provoked craving paradigm (B1) to baseline post provoked craving paradigm (B2) on the average cravings score. Percentage of these responders was calculated to evaluate the provocation rate.|Baseline prior to provoked craving paradigm, baseline post provoked craving paradigm|||percentage|||Number
688482|NCT01466361|Primary|Mean Change From Baseline in Nicotine Cravings VAS Scores in Heavy Smokers|Participants completed a nicotine craving assessment consisting of following five items: I have a desire for a cigarette right now, if it were possible I would smoke right now, All I want right now is a cigarette, I have an urge for a cigarette, I crave a cigarette right now. All participants indicated their craving intensity on a pre-drawn 100 mm scale ranging from 0 (disagree) to 100 (agree). At the end of the craving assessment period, mean VAS score (in mm) was measured.|Baseline, 3 minutes and 15 minutes post-treatment|ITT population: All randomized participants who had at least one cravings assessment measurement post dose.||Score on a scale||Standard Error|Least Squares Mean
688483|NCT01466361|Primary|Mean Change From Baseline in Nicotine Cravings VAS Scores in Light Smokers|Participants completed a nicotine craving assessment consisting of following five items: I have a desire for a cigarette right now, if it were possible I would smoke right now, All I want right now is a cigarette, I have an urge for a cigarette, I crave a cigarette right now. All participants indicated their craving intensity on a pre-drawn 100 mm scale ranging from 0 (disagree) to 100 (agree). At the end of the craving assessment period, mean VAS score (in mm) was measured.|Baseline, 1, 3, 5, 10 and 15 minutes post-treatment|Intent to treat (ITT) population: All randomized participants with at least one cravings assessment measurement post dose were analyzed. No data was imputed in case of dropouts or missing data.||Score on a scale||Standard Error|Least Squares Mean
688484|NCT01466348|Secondary|Adjusted Mean Change From Baseline in Mood Alertness and Physical Sensation Scales (MAPSS) Cognitive Test|Mood patterns was evaluated using the Mood, Alertness and Physical Sensation Scales (MAPSS) which comprised of 23 questions describing moods and physical sensations, on a 9-point scale anchored at the left hand end with ‘not at all’ and the right hand end with ‘extremely’. For each question, ‘9’ represented the ‘best’ score and ‘1’ represented the ‘worst’ score. Mean score was calculated by summing the responses and dividing by the number of questions answered. MAPSS Questionnaire was further divided into three main clusters: Alertness; Anxiety and Headache as per the questions.|Baseline, 30 minutes and up to 60 minutes post treatment administration|ITT population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation.||Score on a scale||Standard Error|Mean
688485|NCT01466348|Secondary|Mean Change From Baseline in Number of Incorrect and Missed Responses to DAT Cognitive Test|For the DAT Cognitive test, auditory and visual stimuli were simultaneously presented and participants were asked to respond to occurrences of ‘s’ (visual) or ‘8’ (auditory). Total test duration was approximately 6 minutes. Mean values of incorrect and missed responses to visual and auditory tests were calculated.|Baseline, 30 minutes and up to 60 minutes post treatment administration|ITT population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation.||Responses||Standard Error|Mean
688486|NCT01466348|Secondary|Adjusted Mean Change From Baseline in Valid Reaction Time to DAT Cognitive Test|For the DAT Cognitive test, auditory and visual stimuli were simultaneously presented and participants were asked to respond to occurrences of ‘s’ (visual) or ‘8’ (auditory). Total test duration was approximately 6 minutes. Mean values of valid reaction time to visual and auditory tests were calculated.|Baseline, 30 minutes and up to 60 minutes post treatment administration|ITT population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation.||msec||Standard Error|Mean
688499|NCT01466192|Primary|Undetectable HCV RNA at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)||After 24 weeks of follow-up|||percentage of subjects achieving SVR||95% Confidence Interval|Number
688487|NCT01466348|Secondary|Adjusted Mean Change From Baseline in Number of Valid Responses to Divided Attention Task (DAT) Cognitive Test|For the DAT Cognitive test, auditory and visual stimuli were simultaneously presented and participants were asked to respond to occurrences of ‘s’ (visual) or ‘8’ (auditory). Total test duration was approximately 6 minutes. Mean values of valid responses to visual and auditory tests were calculated.|Baseline, 30 minutes and up to 60 minutes post treatment administration|ITT population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation.||Valid responses||Standard Error|Mean
688488|NCT01466348|Secondary|Adjusted Mean Change From Baseline in Valid Reaction Time to SAT Cognitive Test|Auditory and visual attention of participants was evaluated using a validated Sustained Attention task. For the sustained visual attention task, participants were required to respond to the letter ‘s’ every time it appears in a continuous stream of letters presented on a screen. For the sustained auditory attention task, participants responded to the number ‘8’ every time it appears in a continuous stream of numbers presented through headphones. Total test duration was approximately 6 minutes. Mean values of valid reaction time to visual and auditory tests were calculated.|Baseline, 30 minutes and up to 60 minutes post treatment administration|ITT population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation.||msec||Standard Error|Mean
688489|NCT01466348|Secondary|Mean Change From Baseline in Number of Incorrect and Missed Responses to SAT Cognitive Test|Auditory and visual attention of participants was evaluated using a validated Sustained Attention task. For the sustained visual attention task, participants were required to respond to the letter ‘s’ every time it appears in a continuous stream of letters presented on a screen. For the sustained auditory attention task, participants responded to the number ‘8’ every time it appears in a continuous stream of numbers presented through headphones. Total test duration was approximately 6 minutes. Mean values of incorrect and missed responses to visual and auditory tests were calculated.|Baseline, 30 minutes and up to 60 minutes post treatment administration|ITT population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation.||Responses||Standard Error|Mean
688490|NCT01466348|Secondary|Adjusted Mean Change From Baseline in Number of Valid Responses to Sustained Attention Tasks (SAT) Cognitive Test|Auditory and visual attention of participants was evaluated using a validated Sustained Attention task. For the sustained visual attention task, participants were required to respond to the letter ‘s’ every time it appears in a continuous stream of letters presented on a screen. For the sustained auditory attention task, participants responded to the number ‘8’ every time it appears in a continuous stream of numbers presented through headphones. Total test duration was approximately 6 minutes. Mean values of valid responses to visual and auditory tests were calculated.|Baseline, 30 minutes and up to 60 minutes post treatment administration|ITT population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation.||Valid responses||Standard Error|Mean
688491|NCT01466348|Secondary|Mean Change From Baseline in Number of Incorrect and Missed Responses to RVIP Cognitive Test|The RVIP assessed the performance of visual attention mechanisms in remaining vigilant to periodically occurring events. Participants monitored a series of single numbers (0-9) appearing in the centre of the screen. During the RVIP task, participants responded to consecutive sequences of three odd or three even numbers by pressing the corresponding response button as quickly and accurately as possible. The test lasted approximately 9 minutes and mean number of valid responses to stimulus was calculated.|Baseline, 30 minutes and up to 60 minutes post treatment administration|ITT population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation.||Responses||Standard Error|Mean
688492|NCT01466348|Secondary|Adjusted Mean Change in Baseline in Valid Reaction Time to RVIP Cognitive Test|The RVIP assessed the performance of visual attention mechanisms in remaining vigilant to periodically occurring events. Participants monitored a series of single numbers (0-9) appearing in the centre of the screen. During the RVIP task, participants responded to consecutive sequences of three odd or three even numbers by pressing the corresponding response button as quickly and accurately as possible. Mean valid reaction time was determined.|Baseline, 30 minutes and up to 60 minutes post treatment administration|ITT population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation.||milliseconds (msec)||Standard Error|Mean
688493|NCT01466348|Secondary|Adjusted Mean Change From Baseline in Number of Valid Responses to RVIP Cognitive Test|The RVIP assessed the performance of visual attention mechanisms in remaining vigilant to periodically occurring events. Participants monitored a series of single numbers (0-9) appearing in the centre of the screen. During the RVIP task, participants responded to consecutive sequences of three odd or three even numbers by pressing the corresponding response button as quickly and accurately as possible. The test lasted approximately 9 minutes and mean number of valid responses to stimulus was calculated.|Baseline to 60 minutes post treatment administration|ITT population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation.||Valid responses||Standard Deviation|Mean
688494|NCT01466348|Primary|Adjusted Mean Change From Baseline in Number of Valid Responses to Rapid Visual Information Processing (RVIP) Cognitive Test|The RVIP assessed the performance of visual attention mechanisms in remaining vigilant to periodically occurring events. Participants monitored a series of single numbers (0-9) appearing in the centre of the screen. During the RVIP task, participants responded to consecutive sequences of three odd or three even numbers by pressing the corresponding response button as quickly and accurately as possible. The test lasted approximately 9 minutes and mean number of valid responses to stimulus was calculated.|Baseline to 30 minutes post treatment administration|Intent-To-Treat (ITT) population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation.||Valid responses||Standard Deviation|Mean
688495|NCT01466270|Secondary|Fatigue|Fatigue is quantified by the FACIT-Fatigue scale. It consists of 13 questions answered on a 0 to 4 point scale. The fatigue score is the sum of the responses (some reverse scored) so that higher values represent less fatigue.|24 weeks|All randomized participants except two who did not provide any data.||units on a scale||Standard Error|Least Squares Mean
688496|NCT01466270|Secondary|HVLT-IR|Hopkins verbal learning test - immediate recall is the number of words (of 12) than can be remembers during three tries. The total score ranges from 0 to 36. Higher is better.|24 weeks|All randomized participants except two who did not provide any data.||number of words recalled||Standard Error|Least Squares Mean
710335|NCT00153179|Primary|Difference in Flow-mediated, Endothelium-dependent Brachial Artery Vasodilation Between Test Agent and Placebo||7 days||||||
688500|NCT01466179|Secondary|Best Response During the Core Study|"Complete Remission (CR):
bone marrow blasts ≤ 5%
no evidence of disease
full recovery of peripheral blood counts:
platelets > 100,000/μL, and
absolute neutrophil count (ANC) > 1,000/μL
Complete Remission With Partial Hematological Recovery (CRh*):
bone marrow blasts ≤ 5%
no evidence of disease
partial recovery of peripheral blood counts:
platelets > 50,000/μL, and
ANC > 500/μL
Blast Free Hypoplastic or Aplastic Bone Marrow:
bone marrow blasts ≤ 5%
no evidence of disease
insufficient recovery of peripheral counts: platelets ≤ 50,000/μL and/or ANC ≤ 500/μL
Partial Remission:
• bone marrow blasts 6% to 25% with at least a 50% reduction from Baseline."|From the first dose of blinatumomab until 30 days after the end of the last infusion during the core study, or until the data cut-off date of 10 October 2013; a maximum of 7.5 months.|Primary analysis set||percentage of participants||95% Confidence Interval|Number
688501|NCT01466179|Secondary|Percentage of Participants With a Best Response of Blast Free Hypoplastic or Aplastic Bone Marrow Within 2 Cycles of Treatment|"Blast Free Hypoplastic or Aplastic Bone Marrow was defined as:
bone marrow blasts ≤ 5%
no evidence of disease
insufficient recovery of peripheral counts: platelets ≤ 50,000/μL and/or absolute neutrophil count (ANC) ≤ 500/μL"|Within the first 2 cycles of treatment, 12 weeks|Primary analysis set||percentage of participants||95% Confidence Interval|Number
688502|NCT01466179|Secondary|Serum Cytokine Peak Levels|"The activation of immune effector cells was monitored by the measurement of peripheral blood cytokine levels including interleukin (IL)-2, IL-4, IL-6, IL-10, tumor necrosis factor (TNF)-α and interferon gamma (IFN)-γ using enzyme-linked immunosorbent assays or cytometric bead assays. The limit of detection of the assay (LOD) was 20 pg/mL and the limit of quantification (LOQ) was 125 pg/mL. Data below LOD were set to 10 pg/mL while data < LOQ and > LOD were reported as measured.
Serum IL-4 levels were below detection limit (< 20 pg/mL) at all time points in all participants studied."|Serum samples were collected on Days 1 and 8 at 2 hours and 6 hours after treatment start, and on Day 2 (24 hours) and Day 3 (48 hours) of each treatment cycle and on Days 9 and 10 after dose step.|Pharmacodynamic Data Set (PDS): All patients who received any infusion of blinatumomab and had at least one pharmacodynamic sample collected. N indicates the number of participants with available data at each time point.||pg/mL||Standard Deviation|Mean
688503|NCT01466179|Secondary|Serum Blinatumomab Concentration at Steady State|The steady state concentration of blinatumomab was summarized as the observed concentrations collected at least 10 hours after the start of the IV infusion or dose step for cycle 1 and cycle 2, respectively. Serum concentrations of blinatumomab were measured using a validated bioassay. The lower limit of quantitation (LLOQ) = 50.0 pg/mL.|Samples were taken before treatment start and on Days 3, 8, 10, 15, 22, and 29 after infusion start during Cycles 1 and 2.|Pharmacokinetic Data Set (PKS) defined as all patients who received any infusion of blinatumomab and had at least one PK sample collected unless significant protocol deviations affected the data analysis or if key dosing, dosing interruption or sampling information was missing.||pg/mL||Standard Deviation|Mean
688504|NCT01466179|Secondary|100-Day Mortality After Allogeneic Hematopoietic Stem Cell Transplant|"The analysis of 100-day mortality after allogeneic HSCT was assessed for all participants who received an allogeneic HSCT while in remission (CR/CRh*) following treatment with blinatumomab. 100-day mortality after allogeneic HSCT was calculated relative to the date of allogeneic HSCT.
Patients alive were censored on the last documented visit date or the date of the last phone contact when the patient was last known to have been alive.
The 100-day mortality rate after allogeneic HSCT was defined as the percentage of patients having died up to 100 days after allogeneic HSCT estimated using the estimated time to death in percent calculated by Kaplan-Meier methods."|From the date of allogeneic HSCT until the data cut-off date of 10 October 2013; median observation time was 7.4 months.|Participants who received an allogeneic HSCT while in remission induced by blinatumomab treatment.||percentage of participants||95% Confidence Interval|Number
688505|NCT01466179|Secondary|Number of Participants With Treatment-emergent Adverse Events|"Adverse events (AEs) were evaluated for severity according to the the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4, as follows: Grade 1 – Mild AE; Grade 2 – Moderate AE; Grade 3 - Severe AE; Grade 4 - Life-threatening or disabling AE; Grade 5 - Death.
The investigator used medical judgment to determine if there was a causal relationship (ie, related, unrelated) between an adverse event and blinatumomab.
An AE was considered “serious” if it resulted in death, was life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant incapacity or substantial disruption to conduct normal life functions, is a congenital anomaly or birth defect or is a medically important condition.
Progressive disease was not an adverse event, per the protocol, unless it was more severe than expected for the patient. Therefore, many deaths due to progressive disease were not counted as adverse events."|From the start of the first infusion to 30 days after the end of the last infusion in the core study or from the start of the first retreatment cycle infusion to 30 days after the end of the last retreatment cycle, median treatment duration was 42.2 days.|Full analysis set (FAS), defined as all patients who received any infusion of blinatumomab.||participants|||Number
688506|NCT01466179|Secondary|Overall Survival|Overall survival was measured for all participants from the time the participant received the first treatment of blinatumomab until death due to any cause or the date of the last follow-up. Participants who did not die were censored on the last documented visit date or the date of the last phone contact when the patient was last known to have been alive. Overall survival was estimated using Kaplan-Meier methods. The median follow-up time with respect to overall survival was calculated by the reverse Kaplan Meier method.|Up to the data cut-off date of 10 October 2013; median observation time was 9.8 months.|Primary analysis set||months||95% Confidence Interval|Median
688507|NCT01466179|Secondary|Event-free Survival|"Event-free survival was calculated from the start date of blinatumomab infusion until the date of bone marrow aspiration at which hematological relapse was first detected, or the date of diagnosis on which the hematological or extramedullary relapse was documented or the date of start of any new therapy for ALL (excluding HSCT), or the date of death, whichever was earlier. Participants who did not achieve complete remission or complete remission with partial hematological recovery during the core study were evaluated as having an event on Day 1. Participants in remission who did not experience hematological relapse, did not receive a new therapy for ALL (excluding HSCT), and did not die were censored on the date of the last available bone marrow aspiration or on the last date of survival follow-up visit, whichever was later.
Event free survival was estimated using Kaplan-Meier methods and the median observation time was calculated by the reverse Kaplan Meier method."|Up to the data cut-off date of 10 October 2013; median observation time was 9.8 months.|Primary analysis set||months||95% Confidence Interval|Median
688508|NCT01466179|Secondary|Relapse-free Survival|"Relapse-free survival was assessed for participants who achieved a complete remission or complete remission with partial hematological recovery during the core study and was measured from the time the participant first achieved remission until first documented relapse or death due to any cause. Participants without a documented relapse (hematological or extramedullary) or who did not die were censored at the time of their last bone marrow assessment or their last survival follow-up visit confirming remission.
Relapse free survival was estimated using Kaplan-Meier methods and the median observation time was calculated by the reverse Kaplan Meier method."|Up to the data cut-off date of 10 October 2013; median observation time was 8.9 months.|Participants who reached complete remission or complete remission with partial hematological recovery during the core study||months||95% Confidence Interval|Median
688509|NCT01466179|Secondary|Percentage of Participants With a Best Response of Partial Remission Within 2 Cycles of Treatment|Partial Remission is defined as bone marrow blasts 6% to 25% with at least a 50% reduction from baseline.|Within the first 2 cycles of treatment, 12 weeks|Primary analysis set||percentage of participants||95% Confidence Interval|Number
688510|NCT01466179|Secondary|Percentage of Participants With a Best Response of Complete Remission With Only Partial Hematological Recovery Within 2 Cycles of Treatment|"Complete Remission With Partial Hematological Recovery was defined by the following criteria:
bone marrow blasts ≤ 5%
no evidence of disease
partial recovery of peripheral blood counts:
platelets > 50,000/μL, and
ANC > 500/μL."|Within the first 2 cycles of treatment, 12 weeks|Primary analysis set||percentage of participants||95% Confidence Interval|Number
688511|NCT01466179|Secondary|Percentage of Participants With a Best Response of Complete Remission Within 2 Cycles of Treatment|"Complete Remission was defined by the following criteria:
bone marrow blasts ≤ 5%
no evidence of disease
full recovery of peripheral blood counts:
platelets > 100,000/μL, and
absolute neutrophil count (ANC) > 1,000/μL"|Within the first 2 cycles of treatment, 12 weeks|Primary analysis set||percentage of participants||95% Confidence Interval|Number
688512|NCT01466179|Secondary|Percentage of Participants Who Received an Allogeneic Hematopoietic Stem Cell Transplant (HSCT) During Blinatumomab Induced Remission|Participants who were eligible for allogeneic HSCT were those who achieved remission (complete response or complete response with partial recovery of peripheral blood counts) after 2 cycles of blinatumomab treatment, and no further anti-leukemic medication was given before HSCT.|Up to the data cut-off date of 10 October 2013. Maximum duration on study was 17.8 months.|Participants who reached complete remission or complete remission with partial hematological recovery during the first 2 cycles of treatment.||percentage of participants||95% Confidence Interval|Number
688513|NCT01466179|Secondary|Time to Hematological Relapse (Duration of Response)|"Time to hematological relapse was measured for participants in remission during the core study (the time from the first infusion through 30 days after the last infusion), from the time the participant first achieved remission until first documented relapse or death due to disease progression. Participants without documented relapse (hematological or extramedullary) and who did not die were censored at the time of their last bone marrow assessment or their last survival follow-up visit confirming remission. Participants who died without having reported hematological relapse or without showing any clinical sign of disease progression were censored on their date of death.
Hematological relapse is defined as:
proportion of blasts in bone marrow > 5% after documented CR/CRh* or
blasts in peripheral blood after documented CR/CRh*.
Time to hematological relapse was analyzed by Kaplan-Meier methods and the median observation time was calculated by the reverse Kaplan Meier method."|Up to the data cut-off date of 10 October 2013; median observation time was 8.0 months.|Participants who reached complete remission or complete remission with partial hematological recovery during the core study.||months||95% Confidence Interval|Median
688514|NCT01466179|Primary|Percentage of Participants With a Best Response of Complete Remission or Complete Remission With Only Partial Hematological Recovery Within 2 Cycles of Treatment|"Hematological assessments were performed from bone marrow biopsy samples. All hematological assessments of bone marrow were reviewed in a central reference laboratory.
Hematological remissions were defined by the following criteria:
Complete Remission (CR):
bone marrow blasts ≤ 5%
no evidence of disease
full recovery of peripheral blood counts:
platelets > 100,000/μL, and
absolute neutrophil count (ANC) > 1,000/μL
Complete Remission With Partial Hematological Recovery (CRh*):
bone marrow blasts ≤ 5%
no evidence of disease
partial recovery of peripheral blood counts:
platelets > 50,000/μL, and
ANC > 500/μL."|Within the first 2 cycles of treatment, 12 weeks|The Primary Analysis Set (PAS), defined as participants from the first 3 stages of the study who received any infusion of blinatumomab.||percentage of participants||95% Confidence Interval|Number
688515|NCT01466153|Secondary|Terminal Half Life (t1/2) of MEDI-551|Terminal phase elimination half-life (T1/2) was the time required for half of the drug to be eliminated from the serum.|Pre-infusion and 1 hour post infusion on Days 2 and 8, Days 15 and 22 of cycle 1|The safety population includes all participants who received any investigational product. Participants whom PK samples were available were analyzed for this outcome measure.||Day||Standard Deviation|Mean
688516|NCT01466153|Secondary|Number of Participants Who Developed Detectable Anti-drug Antibodies (ADA)|A participant was considered ADA-positive across the study if they had a positive reading at any time point during the study.|From treatment administration (Day 1) until disease progression, death, initiation of alternative therapy, withdrawal of consent, or end of study (up to 24 months)|The safety population includes all participants who received any investigational product. Participants whom ADA samples were available were analyzed for this outcome measure.||Participants|||Number
688517|NCT01466153|Secondary|Overall Survival (OS)|OS was determined as the time from the start of treatment with study drug until death due to any cause. For participants who were alive at the end of the study or lost to follow-up, OS was censored on the last date when the participant was known be alive. Kaplan-Meier method was used for evaluation.|From treatment administration (Day 1) until disease progression, death, initiation of alternative therapy, withdrawal of consent, or end of study (up to 24 months)|Intent-to-treat (ITT) population includes all participants who were randomized into the study.||Months||95% Confidence Interval|Number
688518|NCT01466153|Secondary|Progression Free Survival (PFS)|PFS was measured from the start of treatment with study drug until the first documentation of disease progression or death due to any cause, whichever occurred first. Kaplan-Meier method was used for evaluation.|From treatment administration (Day 1) until disease progression, death, initiation of alternative therapy, withdrawal of consent, or end of study (up to 24 months)|Intent-to-treat (ITT) population includes all participants who were randomized into the study.||Months||95% Confidence Interval|Median
688519|NCT01466153|Secondary|Time to Disease Progression (TTP)|TTP was defined as the time from onset of treatment with study drug until first evidence/diagnosis of progressive disease or – in the absence of any diagnosis of progressive disease – until the participant´s death.|From treatment administration (Day 1) until disease progression, death, initiation of alternative therapy, withdrawal of consent, or end of study (up to 24 months)|Intent-to-treat (ITT) population includes all participants who were randomized into the study.||Months||95% Confidence Interval|Median
688520|NCT01466153|Secondary|Time to Response|Time to response was evaluated using the Kaplan-Meier method.|From treatment administration (Day 1) until disease progression, death, initiation of alternative therapy, withdrawal of consent, or end of study (up to 24 months)|Intent-to-treat (ITT) population includes all participants who were randomized into the study.||Months||95% Confidence Interval|Median
688521|NCT01466153|Secondary|Minimal Residual Disease Negative Complete Response (CR) Rate|The MRD-negative CR rate was defined as the percentage of participants who achieved CR and became MRD-negative as determined by flow cytometry. CR as per International Working Group (IWG) was complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy.|From treatment administration (Day 1) until disease progression, death, initiation of alternative therapy, withdrawal of consent, or end of study (up to 24 months)|Intent-to-treat (ITT) population includes all participants who were randomized into the study.||Percentage of Participants||95% Confidence Interval|Number
688522|NCT01466153|Secondary|Complete Response Rate|Complete response was as per IWG was the complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy.|From treatment administration (Day 1) until disease progression, death, initiation of alternative therapy, withdrawal of consent, or end of study (up to 24 months)|Intent-to-treat (ITT) population includes all participants who were randomized into the study.||Percentage of Participants||95% Confidence Interval|Number
688523|NCT01466153|Secondary|Number of Participants With Abnormal Vital Signs and Electrocardiogram Reported as AEs|AEs observed in participants with clinically significant ECG abnormalities were assessed.|From time of consent to 90 days post last dose|The safety population includes all participants who received any investigational product.||Participants|||Number
688524|NCT01466153|Secondary|Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs|An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Laboratory evaluations (haematology, serum chemistry and urinalysis) of blood and urine samples were performed.|From time of consent to 90 days post last dose|The safety population includes all participants who received any investigational product.||Participants|||Number
688525|NCT01466153|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs) and Adverse Events of Special Interest (AESIs)|An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug (MEDI-551). A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience; persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between administration of study drug and Day 90 that were absent before treatment or that worsened relative to pre-treatment state. An AESIs was one of scientific and medical interest specific to understanding of study product and may have required close monitoring and rapid communication by investigator to the sponsor. Treatment emergent AESIs were collected from the time of dosing through Day 90 after the last dose of study drug.Hepatic function abnormality and infusion reactions resulting in discontinuation were considered as AESIs.|From time of consent to 90 days post last dose|The safety population includes all participants who received any investigational product.||Participants|||Number
688526|NCT01466153|Primary|Objective Response Rate|ORR, defined as the proportion of participants with complete response (CR) or partial response (PR) out of total number of participants. Responses were assessed by using National Cancer Institute - Working Group guidelines on CLL.|From treatment administration (Day 1) until disease progression, death, initiation of alternative therapy, withdrawal of consent, or end of study (up to 24 months)|Intent-to-treat (ITT) population includes all participants who were randomized into the study.||Percentage of Participants||95% Confidence Interval|Number
688527|NCT01466127|Primary|Differential Skin Conductance Response (SCR) During the First Two Extinction Trials|Differences in skin conductance response (SCR) between the active vs. placebo conditions trials will be used to assess for the impact of oxytocin on fear acquisition and extinction. We will take a mean of the first two extinction trials to get this measure. Data was gathered in micro-Siemens and then underwent a square root transformation.|Day 2 of Conditioning (1 day post Day 1 of Conditioning)|||micro-Siemens (square rooted)||Standard Deviation|Mean
688528|NCT01466075|Secondary|Number of Subjects Able to Perform Given Tasks Using Product Labeling for Instruction|After reading the instructions for use, and without assistance from the study staff, subjects use the BGMS to perform basic tasks considered to be essential for the operation of the system.|1 hour|Blood data for three subjects were not considered evaluable because the difference between the replicates of the reference YSI analyzer measurements exceeded the protocol defined criteria. Remaining 204 subjects each tested one of three test strip lots on the system. 204 (207-3) test results were available.||participants|||Number
688529|NCT01466075|Secondary|Percent of Venous Blood Glucose Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method|Study staff tested subject venous blood using an investigational Blood Glucose Monitoring System (BGMS). Venous BGMS results are compared with venous plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI venous plasma results are used to calculate the number of BGMS results within +/- 15mg/dL (<75mg/dL YSI venous plasma) or +/- 20% (>=75mg/dL YSI venous plasma).|1 hour|609 venous BG results(203 subjects x 3 test strip lots) were available. Three subjects did not have successful venipunctures so no blood obtained. BGMS testing was not performed with one subject's blood sample. Study staff tested each subject venous blood sample using 3 test strip lots.||percentage of Blood Glucose Test Results|Participants||Number
688637|NCT01464879|Secondary|Pharmacokinetics of Total Testosterone and DHT Measuring Maximum Concentration Observed (Cmax)||Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator|FAS population was used for this analysis, which comprised of all subjects who had any available PK data.||ng/dL||Standard Deviation|Mean
688530|NCT01466075|Secondary|Percent of Glucose Results From Alternative Site Testing (AST) of the Palm Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method|Untrained subjects with diabetes self-test Alternative Site (AST) Palm blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS AST results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma BG results are used to calculate the number of AST BGMS results within +/- 15mg/dL (<75mg/dL YSI capillary plasma) or +/- 20% (>=75mg/dL YSI capillary plasma).|1 hour|Blood data for three subjects were not evaluable because the difference between the replicates of the reference YSI analyzer measurements exceeded the protocol defined criteria. The remaining 204 subjects each tested one of three test strip lots on the system. 204 (207-3) test results were available.||percentage of Blood Glucose Test Results|Participants||Number
688531|NCT01466075|Primary|Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method|Untrained subjects with diabetes self-test fingerstick blood using the Apollo Evolution Investigational Blood Glucose Monitoring System (BGMS). BGMS results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results are used to calculate the number of BGMS results within +/- 15mg/dL (<75mg/dL YSI capillary plasma) or +/- 20% (>=75mg/dL YSI capillary plasma). Site staff tested in parallel after subjects.|1 hour|Blood data for three subjects were not evaluable because the difference between the replicates of the reference YSI analyzer measurements exceeded the protocol defined criteria. Remaining 204 subjects each tested one of three test strip lots on the system. 204 (207-3) test results were available.||percentage of Blood Glucose Test Results|Participants||Number
688532|NCT01466062|Secondary|Urinalysis: Presence of Urine Protein, Glucose, and Occult Blood at Screening and Day 121|The values -, -/+, 1+, 2+, 3+, and 4+ represent a range from none (-) to highest (4+) presence of protein, glucose, and occult blood in the urine. Table presents the number of participants with each value. Those categories with 0 participants to report at either time point are not included in the table below.|Screening, Day 121 (30 days after the 4th dose)|All participants; n=number of participants with measurements at given time points.||participants|||Number
688533|NCT01466062|Secondary|Blood Chemistry: Mean Baseline and Change From Baseline in Total Bilirubin, Blood Urea Nitrogen (BUN), Creatinine, and C-reactive Protein (CRP) at Day 121|Normal ranges for total bilirubin, BUN, creatinine, and CRP varied by the monthly age of the participant.|Baseline (Day 1), Day 121 (30 days after the 4th dose)|All participants with measurements at given time points.||mg/dL||Standard Deviation|Mean
688534|NCT01466062|Secondary|Blood Chemistry: Mean Baseline and Change From Baseline in Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT) at Day 121|Normal ranges for ALP, AST, and ALT varied by the monthly age of the participant.|Baseline (Day 1), Day 121 (30 days after the 4th dose)|All participants with measurements at given time points.||U/L||Standard Deviation|Mean
688535|NCT01466062|Secondary|Hematology: Mean Baseline and Mean Change From Baseline in Red Blood Cells (RBC) and Platelet Count at Day 121|Normal ranges for RBC and platelet count varied by the monthly age of the participant.|Baseline (Day 1), Day 121 (30 days after the 4th dose)|All participants with measurements at given time points.||cells *10^4/µL||Standard Deviation|Mean
688536|NCT01466062|Secondary|Hematology: Mean Baseline and Mean Change From Baseline in White Blood Cells (WBC), Neutrophils, Eosinophils, Basophils, Lymphocytes, and Monocytes at Day 121|Normal ranges for WBC, neutrophils, eosinophils, basophils, lymphocytes, and monocytes varied by the monthly age of the participant.|Baseline (Day 1), Day 121 (30 days after the 4th dose)|All participants; n=number of participants with measurements at given time points.||cells *10^3/µL||Standard Deviation|Mean
688537|NCT01466062|Secondary|Hematology: Mean Baseline and Mean Change From Baseline in Hematocrit at Day 121|Normal range for hematocrit varied by the monthly age of the participant.|Baseline (Day 1), Day 121 (30 days after the 4th dose)|All participants with measurements at given time points.||percentage of red blood cells||Standard Deviation|Mean
688538|NCT01466062|Secondary|Hematology: Mean Baseline and Mean Change From Baseline in Hemoglobin at Day 121|Normal range for hemoglobin varied by the monthly age of the participant.|Baseline (Day 1), Day 121 (30 days after the 4th dose)|All participants with measurements at given time points.||g/dL||Standard Deviation|Mean
688539|NCT01466062|Secondary|Mean Baseline and Mean Change From Baseline in Body Weight at Day 121||Baseline (Day 1), Day 121 (30 days after the 4th dose)|All participants with measurements at given time points.||kilograms||Standard Deviation|Mean
688540|NCT01466062|Secondary|Mean Baseline and Mean Change From Baseline in Pulse Rate at Day 121||Baseline (Day 1), Day 121 (30 days after the 4th dose)|All participants with measurements at given time points.||beats per minute||Standard Deviation|Mean
688541|NCT01466062|Secondary|Mean Baseline and Mean Change From Baseline in Respiratory Rate at Day 121||Baseline (Day 1), Day 121 (30 days after the 4th dose)|All participants with measurements at given time points.||respirations per minute||Standard Deviation|Mean
688542|NCT01466062|Secondary|Mean Baseline and Mean Change From Baseline in Body Temperature at Day 121||Baseline (Day 1), Day 121 (30 days after the 4th dose)|All participants with measurements at given time points.||degrees Celcius||Standard Deviation|Mean
688543|NCT01466062|Secondary|Mean Baseline and Mean Change From Baseline in Systolic/Diastolic Blood Pressure at Day 121||Baseline (Day 1), Day 121 (30 days after the 4th dose)|All participants; n= number of participants with measurements at given time points.||mm Hg||Standard Deviation|Mean
688544|NCT01466062|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs|An adverse event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with treatment. If an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE): results in death or is life-threatening, results in admission or prolongation of hospitalization, results in congenital anomaly or persistent or significant disability/incapacity, or is an important medical event requiring medical or surgical intervention to prevent serious outcome. AEs were categorized by severity (mild, moderate, severe) and relationship to treatment (probably, possibly, probably not, not related). Please see Adverse Events section below for more details.|From the first administration of palivizumab to 100 days after the last administration of palivizumab. Mean (SD) duration of treatment was 183 (37.29) days.|All participants||participants|||Number
694302|NCT01402284|Secondary|Overall Survival (OS) Rate|OS is defined as the time of start of treatment to death from any cause.|up to 6 months|||percentage of participants||95% Confidence Interval|Number
688545|NCT01466062|Secondary|Duration of Required Treatment for Respiratory Syncytial Virus (RSV) Infection|Duration (days) of requirement for any of the investigated treatments (admission in the intensive care unit [ICU], oxygen supplementation, mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure and other mechanical respiratory support) for disease caused by RSV infection after the initial dose to 30 days after the last dose of the study drug.|From the first administration of palivizumab to 30 days after the last administration of palivizumab. Mean (SD) duration of treatment was 183 (37.29) days.|Number of participants who required any of the investigated treatments for RSV. Since no subject had a RSV infection from the first administration of palivizumab to 30 days after the administration of palivizumab, the number of participants analyzed was 0 for this measure.|||||
688546|NCT01466062|Secondary|Duration of Hospitalization Caused by Respiratory Syncytial Virus (RSV) Infection|Number of days of hospitalization caused by RSV infection.|From the first administration of palivizumab to 30 days after the last administration of palivizumab. Mean (SD) duration of treatment was 183 (37.29) days.|Number of participants hospitalized. Since no subject had a RSV infection from the first administration of palivizumab to 30 days after the administration of palivizumab, the number of participants analyzed was 0 for this measure.|||||
688547|NCT01466062|Secondary|Percentage of Participants Who Required Treatment for Respiratory Syncytial Virus (RSV) Infection|Percentage of participants who required any of the investigated treatments (admission in the intensive care unit [ICU], oxygen supplementation, mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure and other mechanical respiratory support) for disease caused by RSV infection after the initial dose to 30 days after the last dose of the study drug.|From the first administration of palivizumab to 30 days after the last administration of palivizumab. Mean (SD) duration of treatment was 183 (37.29) days.|All participants||percentage of participants||95% Confidence Interval|Number
688548|NCT01466062|Secondary|Percentage of Participants Requiring Hospitalization For Respiratory Syncytial Virus (RSV) Infection||From the first administration of palivizumab to 30 days after the last administration of palivizumab. Mean (SD) duration of treatment was 183 (37.29) days.|All participants||percentage of participants||95% Confidence Interval|Number
688549|NCT01466062|Primary|Serum Palivizumab Trough Concentrations at Day 1, Day 31, and Day 121|Serum trough concentrations of palivizumab were assessed at Screening, at Day 31 (30 days after the 1st dose) and Day 121 (30 days after the 4th dose).|Day 1 (Screening), Day 31, Day 121|All participants; n=number of non-missing observations.||µg/mL||Standard Deviation|Mean
688553|NCT01465958|Primary|Mean Trough of Serum Total IgG|Mean trough serum total IgG values were calculated for each subject for the IV Phase (IV #1 and IV #2) and the SC phase (SC Weeks #9 and #12, and End of Treatment/Early termination visit). Mean trough concentration values of serum total IgG during the IV and SC phases were calculated based on the IgG population (subjects who received any amount of study drug and had serum total IgG concentration data).|4 - 5 weeks of IV administration and 12 weeks for SC administration|The IgG Population was used to calculate the trough serum concentrations. The IgG population consisted of all subjects who received any amount of GAMUNEX-C and had any serum total IgG concentration data.||mg/dL||Full Range|Mean
688554|NCT01465958|Primary|Steady-state Area Under the Curve (AUC) for Serum Total Immunoglobulin (IgG)|Steady-state area under the curve (AUC): For the IV phase, the mean adjusted AUC was calculated for all 11 subjects, which included subjects on both 3 and 4 week intravenous (IV) dosing schedules and who had sufficient immunoglobulin G (IgG) data. For the SC phase, the mean AUC was calculated for 10 subjects on weekly subcutaneous (SC) administration and who had sufficient IgG data.|4 to 5 weeks for IV administration; 12 weeks for SC administration|The PK population included the subjects with the availability of sufficient pharmacokinetics (PK) data to calculate area under the curve (AUC) for either the IV or SC phases.||h*mg/dL||Full Range|Mean
688555|NCT01465802|Secondary|Mean Plasma Ctrough for PF-05199265 by Visit for Cohorts I, II and III|"Ctrough was the pre-dose plasma concentration of the dacomitinib metabolite PF-05199265 at steady state obtained from direct inspection of the data.
Number of participants analyzed is the total number of participants in the treatment group in the indicated population, n is the number of participants contributing to the summary statistics."|Cohorts I to III: Pre-dose on Day 1 of Cycle 3 to 10.|Dose-Compliant participants only. Participants were considered dose-compliant when they received at least 14 consecutive doses at the same dose level right before sample collection in Cohorts I, II and III.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
688556|NCT01465802|Secondary|Mean Plasma Trough Concentrations (Ctrough) for Dacomitinib by Visit for Cohorts I, II and III|"Ctrough was the pre-dose plasma concentration of dacomitinib at steady state obtained from direct inspection of the data.
Number of participants analyzed is the total number of participants in the treatment group in the indicated population, n is the number of participants contributing to the summary statistics."|Cohorts I to III: Pre-dose on Day 1 of Cycle 3 to 10.|Dose-Compliant participants only. Participants were considered dose-compliant when they received at least 14 consecutive doses at the same dose level right before sample collection in Cohorts I, II and III.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
688557|NCT01465802|Secondary|Mean Apparent Clearance (CL/F) for Dacomitinib on Cycle 2 Day 1 for Cohort I|CL/F was calculated as dose/AUCtau.|Cycle 2 Day 1: pre-dose and at 2, 4, 6, and 24 hours post-dose|"Dose-Compliant participants only. Participants were considered dose-compliant when they received at least 14 consecutive doses at the same dose level right before sample collection.
Number of participants analyzed is the number of participants contributing to the summary statistics."||Liters per hour||Geometric Coefficient of Variation|Geometric Mean
688558|NCT01465802|Secondary|Median Tmax for Dacomitinib and Its Metabolite PF-05199265 on Cycle 2 Day 1 for Cohort I|Tmax was obtained from direct inspection of the data as the time of first occurence of Cmax.|Cycle 2 Day 1: pre-dose and at 2, 4, 6, and 24 hours post-dose|"Dose-Compliant participants only. Participants were considered dose-compliant when they received at least 14 consecutive doses at the same dose level right before sample collection.
Number of participants analyzed is the number of participants contributing to the summary statistics."||hr||Full Range|Median
688559|NCT01465802|Secondary|Mean Cmax for Dacomitinib and Its Metabolite PF-05199265 on Cycle 2 Day 1 for Cohort I|Cmax was obtained from direct inspection of the data.|Cycle 2 Day 1: pre-dose and at 2, 4, 6, and 24 hours post-dose|"Dose-Compliant participants only. Participants were considered dose-compliant when they received at least 14 consecutive doses at the same dose level right before sample collection.
Number of participants analyzed is the number of participants contributing to the summary statistics."||ng/mL||Geometric Coefficient of Variation|Geometric Mean
688560|NCT01465802|Secondary|Mean AUC From 0 to the End of the Dosing Interval (AUC0-tau) for Dacomitinib and Its Metabolite PF-05199265 on Cycle 2 Day 1 for Cohort I|AUCtau was the AUC from time 0 to the end of the dosing interval, where the dosing interval was 24 hours. AUCtau was calculated by the linear/log trapezoidal method using a non-compartmental PK analysis.|Cycle 2 Day 1: pre-dose and at 2, 4, 6, and 24 hours post-dose|"Dose-Compliant participants only. Participants were considered dose-compliant when they received at least 14 consecutive doses at the same dose level right before sample collection.
Number of participants analyzed is the number of participants contributing to the summary statistics."||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
688561|NCT01465802|Primary|Median Time of Occurrence of Cmax (Tmax) for Dacomitinib and Its Metabolite PF-05199265 on Cycle 1 Days 10 to 15 for Cohort III|Tmax was obtained from direct inspection of the data as the time of first occurence of Cmax.|Cycle 1 Day 10: Pre-dose and 2, 4, 6, 24, 48, 72, 96, and 120 hours post-dose (the 120 hour sample was obtained on Day 15 pre-dose).|Dose-Compliant participants only. Participants were considered dose-compliant when they received all planned doses at the same dose level right before sample collection.||hours (hr)||Full Range|Median
688562|NCT01465802|Primary|Mean Maximum Observed Plasma Concentrations (Cmax) for Dacomitinib and Its Metabolite PF-05199265 on Cycle 1 Days 10 to 15 for Cohort III|Cmax was obtained from direct inspection of the data. ng/mL = nanograms per milliliter|Cycle 1 Day 10: Pre-dose and 2, 4, 6, 24, 48, 72, 96, and 120 hours post-dose (the 120 hour sample was obtained on Day 15 pre-dose).|Dose-Compliant participants only. Participants were considered dose-compliant when they received all planned doses at the same dose level right before sample collection.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
688563|NCT01465802|Primary|Mean Area Under the Plasma Concentration Time Curve From 0 to 24 Hours (AUC0-24) and From 0 to 120 Hours (AUC0-120) for Dacomitinib and Its Metabolite PF-05199265 on Cycle 1 Days 10 to 15 for Cohort III|"AUC0-24 is the area under the plasma concentration-time curve (AUC) from time 0 to 24 hours post-dose. AUC0-120 is the AUC from time 0 to 120 hours post-dose. AUC was calculated by the linear trapezoidal method using a non-compartmental pharmacokinetic (PK) analysis.
ng*hr/mL = nanogram hours per milliliter"|Cycle 1 Day 10: Pre-dose and 2, 4, 6, 24, 48, 72, 96, and 120 hours post-dose (the 120 hour sample was obtained on Day 15 pre-dose).|Dose-Compliant participants only. Participants were considered dose-compliant when they received all planned doses at the same dose level right before sample collection.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
688564|NCT01465802|Secondary|Percentage of Participants Receiving Any Concomitant Drug or Non-Drug Treatment for SDAEI, Diarrhea and Mucositis for Cohort I by Treatment Arm, Cohort II, and Cohort III|Medications used concomitantly for SDAEIs, diarrhea and mucositis were evaluated for all participants who received dacomitinib on a continuous basis with a preemptive prophylactic (Cohorts I and II) or as an interrupted dosing regimen (Cohort III).|Screening to the Post-Teatment Follow-Up Visit (at least 28 days and no more than 35 days after the end of dacomitinib treatment due to progression of disease, intolerance to dacomitinib treatment, or participant withdrawal)|As Treated Population||Percentage of Participants|||Number
688565|NCT01465802|Primary|Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) for Cohort II|"PROs of HRQoL and disease/treatment-related symptoms were assessed using Dermatologic Survey (Skindex-16) that assesses bother. It includes 3 multi-item scales: symptoms, emotions & functioning. Individual scaled scores & total scores were determined. Skindex questions were transformed to a linear scale of 0 (never bothered) to 100 (always bothered). Subscale scores are an average of non-missing questions in a given scale if > 75% of total subscale questions are non-missing. The Total Score is an average of all non-missing questions in the Skindex if >75% of total questions are non-missing. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant.
Skindex completion criteria were defined as completion of 3 out of 4 items for questions 1 to 4, 6 out of 7 items for questions 5 to 11, 4 out of 5 items for questions 12 to 16 for the visit."|Cycles 1, 2, 3, 4, 5, and 6, EoT and Follow-up|PRO Skindex Analysis Population||Score on a scale||Standard Deviation|Mean
688566|NCT01465802|Primary|Percentage of Participants With SDAEI (All Causality, Grade ≥2) in the First 8 Weeks of Treatment for Cohort II|"SDAEI of all causality and Grade ≥2 were evaluated in participants in Cohort II. These SDAEIs included dermatitis acneiform, dry skin, exfoliative rash, nail discoloration, nail disorder, paronychia, pruritus, rash, skin exfoliation, skin fissures, skin infection, skin laceration and skin ulcer. AEs were graded for severity using the NCI-CTCAE, Version 4.0.
95% CI calculated using exact method based on binomial distribution."|First 8 Weeks of Treatment|Evaluable Population||Percentage of Participants||95% Confidence Interval|Number
688596|NCT01465230|Primary|Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|36 months|Participants withdrew from study before primary outcome could be measured|||||
688567|NCT01465802|Primary|Percentage of Participants With SDAEI (All Causality, All Grade) in the First 8 Weeks of Treatment for Cohort II|"SDAEI of all causality and all grades were evaluated in participants in Cohort II. These SDAEIs included dermatitis acneiform, dry skin, exfoliative rash, nail discoloration, nail disorder, paronychia, pruritus, rash, skin exfoliation, skin fissures, skin infection, skin laceration and skin ulcer.
95% CI calculated using exact method based on binomial distribution."|First 8 Weeks of Treatment|Evaluable Population||Percentage of Participants||95% Confidence Interval|Number
688568|NCT01465802|Primary|Mean Change From Baseline (Cycle 1 Day 1) Modified Oral Mucositis Daily Questionnaire (OMDQ) Scores (Mouth and Throat Soreness Categories and Scale, and Diarrhea Categories and Scale) for Cohort II|"Diarrhea severity was assessed using the modified-OMDQ. This questionnaire is comprised of 6 questions in total; however, only two items relate to diarrhea symptoms (item 5 and item 6). Symptoms scores were developed for both the full questionnaire and for the diarrhea-only questions for each completed survey. Mucositis questions were transformed to a score range of 0 to 10. Increasing OMDQ values are associated with greater symptom burden.
Modified OMDQ completion criteria were defined as completion of all 4 questions (questions 2, 4, 5 and 6).
M/T = mouth and throat."|Cycles 1, 2, 3, 4, 5, and 6, EoT and Follow-up|PRO Modified OMDQ Analysis Population; participants meeting primary endpoint analysis & modified OMDQ specific criteria: a) Modified OMDQ completion criteria for initial visit & end of Cycle 2 or EoT visit; b) Completion criteria for at least 5 of 6 visits between initial & end of Cycle 2 visit. n = number of participants completing scale.||Score on a scale||Standard Deviation|Mean
688569|NCT01465802|Primary|Percentage of Participants With Diarrhea AEs (All Causality, All Grade and Grade ≥2) in the First 8 Weeks of Treatment for Cohort II|"Diarrhea AEs of all causality, all grade and Grade ≥2 were evaluated in participants in Cohort II. AEs were graded for severity using the NCI-CTCAE, Version 4.0.
95% CI calculated using exact method based on binomial distribution."|First 8 Weeks of Treatment|Evaluable Population||Percentage of Participants||95% Confidence Interval|Number
688570|NCT01465802|Primary|Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) by Treatment Arm for Cohort I|"Patient Reported Outcomes (PROs) of Health Related Quality of Life (HRQoL) & disease/treatment-related symptoms were assessed using Dermatologic Survey (Skindex-16) that assesses bother. It includes 3 multi-item scales: symptoms, emotions & functioning. Individual scaled scores & total scores were determined. Skindex questions were transformed to a linear scale of 0 (never bothered) to 100 (always bothered). Subscale scores are an average of non-missing questions in a given scale if greater than (>) 75% of total subscale questions are non-missing. The Total Score is an average of all non-missing questions in the Skindex if >75% of total questions are non-missing. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant.
Skindex completion criteria were defined as completion of 3 out of 4 items for questions 1 to 4, 6 out of 7 items for questions 5 to 11, 4 out of 5 items for questions 12 to 16 for the visit."|First 8 Weeks of Treatment|PRO Skindex Analysis Population: participants that met primary endpoint analysis & Skindex specific criteria: a) Skindex completion criteria (as above) for initial visit & end of Cycle 2 or EoT visit; b) Skindex completion criteria for at least 5 of 6 visits between initial visit & end of Cycle 2 visit. n = number of participants completing scale.||Score on a scale||Standard Deviation|Mean
688571|NCT01465802|Primary|Percentage of Participants With SDAEI (All Causality, Grade Greater Than or Equal to [≥] 2) in the First 8 Weeks of Treatment by Treatment Arm for Cohort I|"SDAEI of all causality and Grade ≥2 were evaluated in participants in Cohort I. These SDAEIs included dermatitis acneiform, dry skin, exfoliative rash, nail discoloration, nail disorder, paronychia, pruritus, rash, skin exfoliation, skin fissures, skin infection, skin laceration and skin ulcer. Adverse events (AEs) were graded for severity using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, Version 4.0).
95% CI calculated using exact method based on binomial distribution. After protocol amendment 1, Arm C was removed from Cohort I and enrollment to Arm C was terminated. Only 7 participants were enrolled in Cohort I Arm C as a result. Given the smaller sample size, analyse of Outcome Measure 2 was not conducted in Cohort I Arm C."|First 8 Weeks of Treatment|Evaluable Population||Percentage of Participants||95% Confidence Interval|Number
688572|NCT01465802|Primary|Percentage of Participants With Select Dermatologic Adverse Events of Interest (SDAEI) (All Causality, All Grade) in the First 8 Weeks of Treatment by Treatment Arm for Cohort I|"SDAEI of all causality and all grades were evaluated in participants in Cohort I. These SDAEIs included dermatitis acneiform, dry skin, exfoliative rash, nail discoloration, nail disorder, paronychia, pruritus, rash, skin exfoliation, skin fissures, skin infection, skin laceration and skin ulcer.
95% confidence interval (CI) calculated using exact method based on binomial distribution.
After protocol amendment 1, Arm C was removed from Cohort I and enrollment to Arm C was terminated. Only 7 participants were enrolled in Cohort I Arm C as a result. Given the smaller sample size, analyse of Outcome Measure 1 was not conducted in Cohort I Arm C."|First 8 Weeks of Treatment|Evaluable Population - included all participants who received the study treatment assigned at enrollment, but did not discontinue dacomitinib treatment less than 6 weeks from first dosing due to either disease progression or death.||Percentage of Participants||95% Confidence Interval|Number
688573|NCT01465763|Secondary|Change From Baseline in Total Mayo Scores at Week 8|Change in total Mayo scores at Week 8 relative to Baseline was reported. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher scores indicating more severe disease.|Baseline, Week 8|FAS included all participants randomly assigned to either tofacitinib 10 mg BID or placebo BID. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||units on a scale||Standard Deviation|Mean
688574|NCT01465763|Secondary|Change From Baseline in Partial Mayo Scores at Weeks 2, 4 and 8|Change in partial mayo scores at weeks 2, 4, 8 relative to baseline were reported. A Partial Mayo Score (mayo score without endoscopy) graded from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and PGA) with each grading from 0 to 3 with higher scores indicating more severe disease.|Baseline, Weeks 2, 4, 8|FAS included all participants randomly assigned to either tofacitinib 10 mg BID or placebo BID. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||units on a scale||Standard Error|Least Squares Mean
688575|NCT01465763|Secondary|Partial Mayo Scores|A Partial Mayo Score (mayo score without endoscopy) graded from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and PGA) with each grading from 0 to 3 with higher scores indicating more severe disease.|Baseline, Weeks 2, 4, 8|FAS included all participants randomly assigned to either tofacitinib 10 mg BID or placebo BID. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||units on a scale||Standard Deviation|Mean
688576|NCT01465763|Secondary|Percentage of Participants With Deep Remission at Week 8|Deep remission in participants was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and 0 subscore for both rectal bleeding and endoscopic subscores. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher scores indicating more severe disease.|Week 8|FAS included all participants randomly assigned to either tofacitinib 10 mg BID or placebo BID.||percentage of participants|||Number
688577|NCT01465763|Secondary|Percentage of Participants With Symptomatic Remission at Week 8|Symptomatic remission in participants was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point, and 0 subscore for both rectal bleeding and stool frequency. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher scores indicating more severe disease.|Week 8|FAS included all participants randomly assigned to either tofacitinib 10 mg BID or placebo BID.||percentage of participants|||Number
688578|NCT01465763|Secondary|Percentage of Participants With Clinical Remission at Week 8|Clinical remission in participants was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher scores indicating more severe disease.|Week 8|FAS included all participants randomly assigned to either tofacitinib 10 mg BID or placebo BID.||percentage of participants|||Number
688579|NCT01465763|Secondary|Percentage of Participants With Endoscopic Remission at Week 8|Endoscopic remission in participants was defined by Mayo endoscopic subscore of 0. The Mayo endoscopic subscore consisted of the findings of centrally read flexible proctosigmoidoscopy, graded from 0 to 3 with higher scores indicating more severe disease.|Week 8|FAS included all participants randomly assigned to either tofacitinib 10 mg BID or placebo BID.||percentage of participants|||Number
688580|NCT01465763|Secondary|Percentage of Participants Achieving Clinical Response at Week 8|Clinical response in participants was defined by a decrease from baseline in Mayo score of at least 3 points and at least 30 percent, with an accompanying decrease in the rectal bleeding subscore of at least 1 point or an absolute rectal bleeding subscore of 0 or 1. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher scores indicating more severe disease.|Week 8|FAS included all participants randomly assigned to either tofacitinib 10 mg BID or placebo BID.||percentage of participants|||Number
688581|NCT01465763|Secondary|Percentage of Participants Achieving Mucosal Healing at Week 8|Mucosal healing in participants was defined by Mayo endoscopic subscore of 0 or 1. The Mayo endoscopic subscore consisted of the findings of centrally read flexible proctosigmoidoscopy, graded from 0 to 3 with higher scores indicating more severe disease.|Week 8|FAS included all participants randomly assigned to either tofacitinib 10 mg BID or placebo BID.||percentage of participants|||Number
688582|NCT01465763|Primary|Percentage of Participants With Remission at Week 8|Remission in participants was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score is an instrument designed to measure disease activity of ulcerative colitis (UC). It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and physician global assessment (PGA), each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher scores indicating more severe disease.|Week 8|Full analysis set (FAS) included all participants randomly assigned to either tofacitinib 10 mg BID or placebo BID.||percentage of participants|||Number
688583|NCT01465412|Secondary|Cmax of Preladenant Calculated Using Free Drug Concentration After a Single Dose of Preladenant|For healthy and HI participants blood samples were collected at pre-dose (0 hour) and at 0.50, 1, 2, 4, 6, 12, 16, 24, 30, 36, and 48 hours postdose. Blood samples were also collected for HI participants only at 60 and 72 hours postdose in order to determine the Cmax of preladenant calculated using free drug concentration.|Pre-dose up to 72 hours postdose|All participants who received an oral dose of preladenant and for whom at least one pharmacokinetic parameter can be calculated for the treatment phase according to the protocol and who did not have any protocol deviation interfering with pharmacokinetics.||ng/mL||Full Range|Least Squares Mean
688584|NCT01465412|Secondary|AUC 0-t of Preladenant Calculated Using Free Drug Concentration After a Single Dose of Preladenant|For healthy and HI participants blood samples were collected at pre-dose (0 hour) and at 0.50, 1, 2, 4, 6, 12, 16, 24, 30, 36, and 48 hours postdose. Blood samples were also collected for HI participants only at 60 and 72 hours postdose in order to determine the AUC 0-t of preladenant calculated using free drug concentration.|Pre-dose up to 72 hours postdose|All participants who received an oral dose of preladenant and for whom at least one pharmacokinetic parameter can be calculated for the treatment phase according to the protocol and who did not have any protocol deviation interfering with pharmacokinetics.||hr*ng/mL||Full Range|Least Squares Mean
688597|NCT01465178|Secondary|Change in Parameters of the Vitamin D Assay Panel|Secondary outcomes are change in cholecalciferol, 24,25(OH)D3 and free 25(OH)D3.|Baseline, 1 and 4 months post supplementation|Postmenopausal Caucasian women with 25(OH)D < 10 > 30 ng/ml||ng/ml||Standard Deviation|Mean
688585|NCT01465412|Secondary|Cmax of Preladenant Metabolite SCH 446637 After a Single Dose of Preladenant|For healthy and HI participants blood samples were collected at pre-dose (0 hour) and at 0.50, 1, 2, 4, 6, 12, 16, 24, 30, 36, and 48 hours postdose. Blood samples were also collected for HI participants only at 60 and 72 hours postdose in order to determine the Cmax of SCH 446637.|Pre-dose up to 72 hours postdose|All participants who received an oral dose of preladenant and for whom at least one pharmacokinetic parameter can be calculated for the treatment phase according to the protocol and who did not have any protocol deviation interfering with pharmacokinetics.||ng/mL||Full Range|Least Squares Mean
688586|NCT01465412|Secondary|AUC 0-t of Preladenant Metabolite SCH 446637 After a Single Dose of Preladenant|For healthy and HI participants blood samples were collected at pre-dose (0 hour) and at 0.50, 1, 2, 4, 6, 12, 16, 24, 30, 36, and 48 hours postdose. Blood samples were also collected for HI participants only at 60 and 72 hours postdose in order to determine the AUC 0-t of SCH 446637.|Pre-dose up to 72 hours postdose|All participants who received an oral dose of preladenant and for whom at least one pharmacokinetic parameter can be calculated for the treatment phase according to the protocol and who did not have any protocol deviation interfering with pharmacokinetics.||hr*ng/mL||Full Range|Least Squares Mean
688587|NCT01465412|Secondary|Cmax of Preladenant Metabolite SCH 434748 After a Single Dose of Preladenant|For healthy and HI participants blood samples were collected at pre-dose (0 hour) and at 0.50, 1, 2, 4, 6, 12, 16, 24, 30, 36, and 48 hours postdose. Blood samples were also collected for HI participants only at 60 and 72 hours postdose in order to determine the Cmax of SCH 434748.|Pre-dose up to 72 hours postdose|All participants who received an oral dose of preladenant and for whom at least one pharmacokinetic parameter can be calculated for the treatment phase according to the protocol and who did not have any protocol deviation interfering with pharmacokinetics.||ng/mL||Full Range|Least Squares Mean
688588|NCT01465412|Secondary|AUC 0-t of Preladenant Metabolite SCH 434748 After a Single Dose of Preladenant|For healthy and HI participants blood samples were collected at pre-dose (0 hour) and at 0.50, 1, 2, 4, 6, 12, 16, 24, 30, 36, and 48 hours postdose. Blood samples were also collected for HI participants only at 60 and 72 hours postdose in order to determine the AUC 0-t of SCH 434748.|Pre-dose up to 72 hours postdose|All participants who received an oral dose of preladenant and for whom at least one pharmacokinetic parameter can be calculated for the treatment phase according to the protocol and who did not have any protocol deviation interfering with pharmacokinetics.||hr*ng/mL||Full Range|Least Squares Mean
688589|NCT01465412|Primary|Maximum Observed Plasma Concentration (Cmax) of Preladenant After a Single Dose of Preladenant|For healthy and HI participants blood samples were collected at pre-dose (0 hour) and at 0.50, 1, 2, 4, 6, 12, 16, 24, 30, 36, and 48 hours postdose. Blood samples were also collected for HI participants only at 60 and 72 hours postdose in order to determine the Cmax of preladenant.|Pre-dose up to 72 hours postdose|All participants who received an oral dose of preladenant and for whom at least one pharmacokinetic parameter can be calculated for the treatment phase according to the protocol and who did not have any protocol deviation interfering with pharmacokinetics.||ng/mL||Full Range|Least Squares Mean
688590|NCT01465412|Primary|Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Time of the Last Quantifiable Concentration (AUC 0-t) of Preladenant After a Single Dose of Preladenant|For healthy and HI participants blood samples were collected at pre-dose (0 hour) and at 0.50, 1, 2, 4, 6, 12, 16, 24, 30, 36, and 48 hours postdose. Blood samples were also collected for HI participants only at 60 and 72 hours postdose in order to determine the AUC 0-t of preladenant.|Pre-dose up to 72 hours postdose|All participants who received an oral dose of preladenant and for whom at least one pharmacokinetic parameter can be calculated for the treatment phase according to the protocol and who did not have any protocol deviation interfering with pharmacokinetics.||hr*ng/mL||Full Range|Least Squares Mean
688591|NCT01465386|Primary|Progression Free Survival (PFS)|Number of days from enrollment to recurrence of acute myeloid leukemia as determined by the reappearance of blasts in the blood or marrow|Up to 2 years|Patient who began maintenance treatment with bortezomib after induction of remission||days|Participants|Full Range|Median
688592|NCT01465347|Secondary|Number of Participants With Reduction in Tumor Size, According to Percentage of Tumor Reduction|The sum of the product of the diameters of the tumor (using recorded tumor diameter measurements made from brain MRI images) was used to express tumor size. Results were summarized for actual and percentage change from baseline. Individual subjects results were listed, including tumor volume and tumor response from independent reviewers. Investigator data were listed but not used in the analysis. Percent response (according to independent reviewer assessments) by percentage tumor reduction from tumor resection or definitive biopsy to the last MRI were summarized.|From Baseline to Week 110|Of the 56 modified ITT population (subjects in the TSC 18 dose group) tumor size data exist for 37 subjects. Four (4) tumor-bearing subjects at baseline MRI did not have any post-baseline MRIs. Fourteen (14) subjects had a complete resection before baseline.||Participants|||Count of Participants
688593|NCT01465347|Secondary|Progression-Free Survival (PFS)|The PFS analyses were performed using the Kaplan-Meier estimate method. The PFS rates at 6, 12, 18 and 24 months were estimated. Median PFS values were calculated; a corresponding 95% confidence interval for each median value was determined using a log rank analysis. Time to disease progression (in months) was calculated as follows: date of event* or censoring - date of surgery or definitive biopsy / 30.4375; *event = first tumor progression or death.|6,12,18, 24 months|The analysis of PFS was performed in phase 2 only and included the modified ITT population which included 54 of the 56 subjects (98.2%) at the 2-year time point.||percentage of participants||95% Confidence Interval|Number
688594|NCT01465347|Primary|Overall Survival|Participants in phase 2 (18 dose group, 6 weeks treatment with TSC) were monitored for up to 3 years (last follow-up - February 16, 2016). Overall Survival (OS) was defined as the length of time from the date of tumor resection surgery or definitive biopsy to the date of death. The OS analyses were performed using the Kaplan-Meier estimate method. The OS rates at 6, 12, 18 and 24 months were estimated. Median OS values were calculated; a corresponding 95% confidence interval for each median value was determined using a log rank analysis. The length of OS (in months) was calculated as follows: date of death or censored - date of surgery or definitive biopsy / 30.4375.|6, 12, 18, 24 months|All participants who received any amount of TSC and at least 1 session of RT (modified ITT)||participants||95% Confidence Interval|Number
688595|NCT01465347|Primary|Dose Limiting Toxicities (DLTs)|Number of Participants in Phase 1 with Dose Limiting Toxicities (DLTs)|During phase 1|Dose limiting toxicities were only assessed for Phase 1 participants||Participants|||Count of Participants
688600|NCT01465048|Secondary|Frequency, Incidence and Nature of Adverse Events and Serious Adverse Events Arising.|To assess the safety of PfSPZ Challenge administered in various regimens by analysing actively and passively collected data from clinical review of volunteers and laboratory measurements, including lab reports and adverse events.|Participants will be followed for the duration of the study, an expected average of 3 months||||||
688601|NCT01465048|Primary|Number of Participants Infected|To determine the infectivity rates of PfSPZ Challenge administered in various regimens by thick film microscopy and highly sensitive PCR for Plasmodium falciparum DNA.|21 days post administration of PfSPZ Challenge|||Participants|||Number
688602|NCT01465022|Secondary|Infant Occipitofrontal Circumference Growth From 2-8 Weeks|Comparison of infant growth at 2 weeks and 8 weeks between postpartum breastfeeding women using progestin-only pills vs. combined pills. Inclusion criteria of mother's who are actively breastfeeding.|Week 2 and Week 8|"At 2 week point 64 participants for follow-up in combined pills arm, 63 for follow-up in progestin-only pills arm.
At 8 week point 41 participants for follow-up in combined pills arm, 40 for follow-up in progestin-only pills arm."||cm||Standard Deviation|Mean
688603|NCT01465022|Secondary|Infant Weight Growth From 2-8 Weeks|Comparison of infant growth at 2 weeks and 8 weeks between postpartum breastfeeding women using progestin-only pills vs. combined pills. Inclusion criteria of mother's who are actively breastfeeding.|Week 2 and Week 8|"At 2 week point 64 participants for follow-up in combined pills arm, 63 for follow-up in progestin-only pills arm.
At 8 week point 41 participants for follow-up in combined pills arm, 40 for follow-up in progestin-only pills arm."||kg||Standard Deviation|Mean
688604|NCT01465022|Secondary|Infant Length Growth From 2-8 Weeks|Comparison of infant length at 2 weeks and 8 weeks between postpartum breastfeeding women using progestin-only pills vs. combined pills. Inclusion criteria of mother's who are actively breastfeeding.|Week 2 and Week 8|"At 2 week point 64 participants for follow-up in combined pills arm, 63 for follow-up in progestin-only pills arm.
At 8 week point 41 participants for follow-up in combined pills arm, 40 for follow-up in progestin-only pills arm."||cm||Standard Deviation|Mean
688605|NCT01465022|Secondary|Number of Participants Who Continued Birth Control Method After 6 Months|Proportion of participants who are continuing to use either combined estrogen-progestin pill or progestin-only pill up to 6 months after delivery|Baseline to Week 8, Week 8, 2-6 months|Participants available for follow-up through a 6 month period||participants|||Number
688606|NCT01465022|Primary|Number of Participants Who Continued to Breastfeed at 6 Months|Proportion of participants who are continuing to breastfeed from 2 months to 6 months after delivery|Baseline to Week 8, Week 8, 2-6 months|Participants available for follow-up through a 6 month period||participants|||Number
688607|NCT01464996|Secondary|Post Operative Sensitivity|Percentage of restorations with alfa scores. No sensitivity.|18 months post-baseline|||% of restorations with alfa scores|Participants||Number
688608|NCT01464996|Secondary|Marginal Adaptation and/or Integrity|Percentage of restorations with alfa scores. No discoloration is present anywhere on the margin between the restoration and the tooth structure.|18 months post-baseline|||% of restorations with alfa scores|Participants||Number
688609|NCT01464996|Secondary|Anatomic Form|Percentage of restorations with alfa scores. Restoration is continuous with existing anatomic form.|18 months post-baseline|||% of restorations with alfa scores|Participants||Number
688610|NCT01464996|Secondary|Secondary Caries|Percentage of restorations with alfa scores. Absence of caries is evidenced by softness, opacity, or etching at the margin of the restoration.|18 months post-baseline|||% of restorations with alfa scores|Participants||Number
688611|NCT01464996|Secondary|Cavosurface Margin Discoloration|Percentage of restorations scoring alfa. No discoloration is present anywhere on the margin between the restoration and the tooth structure.|18 months post-baseline|||% of restorations with alfa scores|Participants||Number
688612|NCT01464996|Secondary|Color Match|Percentage of restorations that scored alfa. Restoration matches adjacent tooth structure in color, shade and translucency.|18 months post-baseline|||% of restorations with alfa scores|Participants||Number
688613|NCT01464996|Primary|Retention|Overall retention of restorations|6 and 18 months post-baseline|what is reported here is the retention rate using the restoration as the unit of analysis||percentage of restorations|Participants||Number
688614|NCT01464931|Secondary|Number of Participants Who Developed Anti-denosumab Antibodies||From Day 1 (predose) to Day 113|Safety analysis set||participants|||Number
688615|NCT01464931|Secondary|Percent Change From Baseline in Serum C-Telopeptide Over Time||Baseline and Days 1 and 29 (predose), and on Days 8, 15, 36, 43, 57, 71, 85, and 113|Pharmacodynamic Analysis Set (all participants who received at least 1 dose of denosumab and from whom baseline and at least 1 postbaseline value was collected)||percent change||Inter-Quartile Range|Median
688616|NCT01464931|Secondary|Area Under the Serum Concentration-time Curve From Time 0 to 12 Weeks (AUC0-12wks) After Dose 2|Estimated using the linear trapezoidal method.|Days 29 (predose), 36, 43, 57, 71, and 85|PK Parameter Analysis Set||μg*day/mL||Standard Deviation|Mean
688617|NCT01464931|Secondary|Area Under the Serum Concentration-time Curve From Time 0 to 4 Weeks (AUC0-4wks) After Dose 1|Estimated using the linear trapezoidal method.|Days 1, 8, 15, and 29 (predose)|PK Parameter Analysis Set||μg*day/mL||Standard Deviation|Mean
688618|NCT01464931|Secondary|Time to Maximum Observed Serum Denosumab Concentration (Tmax)|Serum concentrations of denosumab were measured by an enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 20 ng/mL.|Days 1 and 29 (predose), and on Days 8, 15, 36, 43, 57, 71, 85, and 113|PK Parameter Analysis Set||days||Full Range|Median
688619|NCT01464931|Secondary|Maximum Observed Serum Denosumab Concentration (Cmax)|Serum concentrations of denosumab were measured by an enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 20 ng/mL.|Days 1 and 29 (predose), and on Days 8, 15, 36, 43, 57, 71, 85, and 113|Pharmacokinetic (PK) Parameter Analysis Set (all participants who received at least 1 dose of denosumab and for whom PK parameter estimates could be derived)||μg/mL||Standard Deviation|Mean
688638|NCT01464879|Secondary|Pharmacokinetics of Total Testosterone and DHT Measuring Time of Maximum Observed Concentration (Tmax)||Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator|FAS population was used for this analysis, which comprised of all subjects who had any available PK data.||hr||Full Range|Median
688983|NCT01460732|Primary|Awake Diastolic Home Blood Pressure Measurement|Awake Home Blood Pressure measurement includes duplicate BP measurements in the morning and in the evening, as per protocol.|2 weeks|||mmHg||Standard Deviation|Mean
688620|NCT01464931|Secondary|Number of Participants With Adverse Events|The severity of each adverse event (AE) was graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. The investigator assessed whether AEs were possibly related to study drug by answering the question: “Is there a reasonable possibility that the event may have been caused by the investigational product?” Abnormal laboratory findings without clinical significance (based on the investigator's judgment) were not recorded as AEs, however, laboratory value changes that required treatment or adjustment in current therapy were considered AEs. A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria: • fatal, • life-threatening (places the participant at immediate risk of death), • requires in-patient hospitalization or prolongation of existing hospitalization, • results in persistent or significant disability/incapacity, • congenital anomaly/birth defect, and/or • other medically important serious event.|113 days|Safety analysis set||participants|||Number
688621|NCT01464931|Secondary|Percent Change From Baseline in Serum Magnesium Over Time||Baseline and Days 2, 3, 6, 8, 11, 15, 22, 29, 30, 31, 34, 36, 39, 43, 57, 71, 85, and 113|Safety analysis set with available data at each time point||percent change||Inter-Quartile Range|Median
688622|NCT01464931|Secondary|Percent Change From Baseline in Serum Phosphorus Over Time||Baseline and Days 2, 3, 6, 8, 11, 15, 22, 29, 30, 31, 34, 36, 39, 43, 57, 71, 85, and 113|Safety analysis set with available data at each time point||percent change||Inter-Quartile Range|Median
688623|NCT01464931|Secondary|Percent Change From Baseline in Albumin-adjusted Serum Calcium Over Time||Baseline and Days 2, 3, 6, 8, 11, 15, 22, 29, 30, 31, 34, 36, 39, 43, 57, 71, 85, and 113|Safety analysis set with available data at each time point||percent change||Inter-Quartile Range|Median
688624|NCT01464931|Secondary|Number of Participants With Hypomagnesemia Determined by CTCAE v.4.0 Criteria|The severity of hypomagnesemia (a low concentration of magnesium in the blood) was graded according to the common terminology criteria for adverse events (CTCAE) v.4.0 criteria: Grade 1: < LLN (1.5 mg/dL) - 1.2 mg/dL; Grade 2: < 1.2 - 0.9 mg/dL; Grade 3: < 0.9 - 0.7 mg/dL; Grade 4: < 0.7 mg/dL.|113 days|Safety analysis set||participants|||Number
688625|NCT01464931|Secondary|Number of Participants With Hypophosphatemia Determined by CTCAE v.4.0 Criteria|The severity of hypophosphatemia (a low concentration of phosphates in the blood) was graded according to the common terminology criteria for adverse events (CTCAE) v.4.0 criteria: Grade 1: < LLN (3 mg/dL) - 2.5 mg/dL; Grade 2: < 2.5 - 2.0 mg/dL; Grade 3: < 2.0 - 1.0 mg/dL; Grade 4: < 1.0 mg/dL.|113 days|Safety analysis set||participants|||Number
688626|NCT01464931|Secondary|Number of Participants With Hypocalcemia Determined by CTCAE v.4.0 Criteria|The severity of hypocalcemia (a low concentration of calcium, corrected for albumin, in the blood) was graded according to the common terminology criteria for adverse events (CTCAE) v.4.0 criteria: Grade 1: albumin-adjusted serum calcium < lower limit of normal (LLN; 9.2 mg/dL) to 8.0 mg/dL; Grade 2: albumin-adjusted serum calcium < 8.0 to 7.0 mg/dL; Grade 3: albumin-adjusted serum calcium < 7.0 to 6.0 mg/dL; Grade 4: albumin-adjusted serum calcium < 6.0 mg/dL.|113 days|Safety analysis set||participants|||Number
688627|NCT01464931|Primary|Number of Participants With Clinically Significant Hypocalcemia|Clinically significant hypocalcemia is defined as albumin-adjusted calcium < 7.0 mg/dL or symptomatic hypocalcemia. Symptomatic hypocalcemiais is defined as both a clinical adverse event of hypocalcemia and a concomitant symptom of hypocalcemia (e.g., hypoesthesia, paresthesia, muscle cramps, seizure, prolonged QT interval) that occurred along with the hypocalcemia event or decreased serum calcium levels.|113 days|Safety Analysis Set (all participants who received at least 1 dose of denosumab)||participants|||Number
688628|NCT01464879|Secondary|Pharmacokinetics of Total Testosterone and DHT Measuring Tmin||Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand|FAS population was used for this analysis, which comprised of all subjects who had any available PK data.||hr||Full Range|Median
688629|NCT01464879|Secondary|Pharmacokinetics of Total Testosterone and DHT Measuring Cmin||Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand|FAS population was used for this analysis, which comprised of all subjects who had any available PK data.||ng/dL||Standard Deviation|Mean
688630|NCT01464879|Secondary|Pharmacokinetics of Total Testosterone and DHT Measuring Cavg||Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand|FAS population was used for this analysis, which comprised of all subjects who had any available PK data.||ng/dL||Standard Deviation|Mean
688631|NCT01464879|Secondary|Pharmacokinetics of Total Testosterone and DHT Measuring Cmax||Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand|FAS population was used for this analysis, which comprised of all subjects who had any available PK data.||ng/dL||Standard Deviation|Mean
688632|NCT01464879|Secondary|Pharmacokinetics of Total Testosterone and DHT Measuring Tmax||Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand|FAS population was used for this analysis, which comprised of all subjects who had any available PK data.||hr||Full Range|Median
688633|NCT01464879|Secondary|Pharmacokinetics of Total Testosterone and DHT Measuring AUCτ||Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand|FAS population was used for this analysis, which comprised of all subjects who had any available PK data.||ng*hr/dL||Standard Deviation|Mean
688634|NCT01464879|Secondary|Pharmacokinetics of Total Testosterone and DHT Measuring Time of Minimum Observed Concentration (Tmin)||Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator|FAS population was used for this analysis, which comprised of all subjects who had any available PK data.||hr||Full Range|Median
688635|NCT01464879|Secondary|Pharmacokinetics of Total Testosterone and DHT Measuring Minimum Concentration Observed (Cmin)||Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator|FAS population was used for this analysis, which comprised of all subjects who had any available PK data.||ng/dL||Standard Deviation|Mean
688636|NCT01464879|Secondary|Pharmacokinetics of Total Testosterone and DHT Measuring Cavg||Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator|FAS population was used for this analysis, which comprised of all subjects who had any available PK data.||ng/dL||Standard Deviation|Mean
688639|NCT01464879|Secondary|Pharmacokinetics of Total Testosterone and DHT (Dihydrotestosterone) Measuring Area Under the Concentration-time Curve From the Last Dose and 24 Hrs. Post Dose (AUCτ)||Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator|FAS population was used for this analysis, which comprised of all subjects who had any available PK data.||ng*hr/dL||Standard Deviation|Mean
688640|NCT01464879|Secondary|Responder Rate: Percentage of Subjects Whose Cavg Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL Following Treatment With One Volume of FE 999303 Applied by Hand.||Days 1-7|FAS population was used for this analysis, which comprised of all subjects who had any available PK data.||percentage of subjects|||Number
688641|NCT01464879|Primary|Responder Rate: Percentage of Subjects Whose Average Steady State Concentration (Cavg) of Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL Following Treatment With Each of Three Volumes of FE 999303 Applied With an Applicator.|Descriptive statistics was used to present the outcome results.|Days 15-21, Days 22-28 & Days 29-35|Full Analysis Set (FAS) population was used for this analysis, which comprised of all subjects who had any available Pharmacokinetic (PK) data.||percentage of subjects|||Number
688642|NCT01464840|Primary|Number of Patients in Each Group That Attain an Adequate Azithromycin Concentration|The primary outcome of this study will be the number of patients in each group that attain an azithromycin concentration in the various maternal and fetal tissues at least equivalent to the MIC 90 for common organisms involved in post-cesarean infections.|48 hours after delivery|No patients had azithromycin concentrations at least equivalent to the MIC 90.||number of participants|||Number
688643|NCT01464827|Secondary|Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose in Treatment-naïve Versus Null-responders|This outcome measure compares the percentage of participants achieving sustained virologic response 24 weeks post-dose (HCV RNA < LLOQ at post-treatment Week 24) following treatment with 3 DAAs and ribavirin in participants who were treatment-naïve versus those who were null-responders to previous HCV therapy (Groups F + G + H + I versus Groups K + L + M + N).|Post-Treatment Week 24|Intent-to-treat population; participants with missing data were counted as non-responders.||percentage of participants|||Number
688644|NCT01464827|Secondary|Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose Following Treatment for 12 Weeks With 3 DAAs With Versus Without Ribavirin|This outcome measure compares the percentage of participants achieving sustained virologic response 24 weeks post-dose (HCV RNA < LLOQ at post-treatment Week 24) following treatment with 3 DAAs with or without ribavirin (Group E versus Groups F + G + K + L).|Post-Treatment Week 24|Intent-to-treat population; participants with missing data were counted as non-responders.||percentage of participants|||Number
688645|NCT01464827|Secondary|Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose Following Treatment for 12 Weeks With 2 DAAs and Ribavirin Versus 3 DAAs and Ribavirin|This outcome measure compares the percentage of participants achieving sustained virologic response 24 weeks post-dose (HCV RNA < LLOQ at post-treatment Week 24) following treatment with 2 DAAs (ABT-450/ritonavir plus ABT-333 [Group B] or ABT-450/ritonavir plus ABT-267 [Groups C + D + J]) and ribavirin versus 3 DAAs (ABT-450/ritonavir plus ABT-333 and ABT-267) and ribavirin (Groups F + G + K + L).|Post-Treatment Week 24|Intent-to-treat population; participants with missing data were counted as non-responders.||percentage of participants|||Number
688646|NCT01464827|Secondary|Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose Following Treatment of Different Durations With 3 Direct-acting Antiviral Agents (DAAs) and Ribavirin|This outcome measure compares the percentage of participants achieving sustained virologic response 24 weeks after the last dose of study drug (HCV RNA < LLOQ at post-treatment Week 24) following treatment with 3 DAAs (ABT-450/ritonavir, ABT-267, and ABT-333) and ribavirin in both treatment naïve and null-responder participants for 8 weeks (Group A) versus 12 weeks (Groups F + G + K + L) versus 24 weeks (Groups H + I + M + N).|Post-Treatment Week 24|Intent-to-treat population; participants with missing data were counted as non-responders.||percentage of participants|||Number
688647|NCT01464827|Primary|Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose for 8 Weeks Versus 12 Weeks of Treatment With 3 DAAs and Ribavirin|"The percentage of participants achieving sustained virologic response 24 weeks after the last dose of study drug (SVR24), defined as hepatitis C virus (HCV) ribonucleic acid (RNA) less than the lower limit of quantitation (LLOQ), without any confirmed quantifiable (≥ LLOQ) post-treatment value before that time point. HCV RNA levels were measured from plasma by a central laboratory. The LLOQ for the assay was 25 IU/mL.
The primary efficacy endpoint was the comparison between treatment-naïve participants following 8 weeks of treatment with 3 DAAs and ribavirin and those with 12 weeks of treatment with 3 DAAs and ribavirin (Group A versus Group G)."|Post Treatment Week 24|Intent-to-treat population (all participants who received at least 1 dose of direct-acting antiviral agent); participants with missing data were counted as non-responders.||percentage of participants|||Number
688648|NCT01464827|Primary|Number of Participants With Adverse Events (AEs)|"An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment.
The investigator assessed the relationship of each AE to the use of direct-acting antiviral agents (DAAs) and to ribavirin, and rated the severity of each event as either:
Mild: The AE was transient and easily tolerated by the participant; Moderate: The AE caused the participant discomfort and interrupted usual activities; Severe: The AE caused considerable interference with the participant's usual activities and could have been incapacitating or life-threatening.
A serious adverse event was any event that resulted in death, was life-threatening, resulted in or prolonged hospitalization, resulted in a congenital anomaly or persistent or significant disability or was any other important medical event requiring medical or surgical intervention."|From the time of study drug administration until 30 days following discontinuation of study drug administration (up to 28 weeks).|Safety population. Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.||participants|||Number
688668|NCT01464359|Secondary|Incidence of Graft Failure|Incidence of graft failure defined as an absolute neutrophil count of less than 500/uL and a bone marrow that is less than 5% cellular (marrow aplasia)|Day 42|||Participants|||Count of Participants
688984|NCT01460732|Primary|Awake Systolic Home Blood Pressure Measurement|Awake Home Blood Pressure measurement includes duplicate BP measurements in the morning and in the evening, as per protocol.|2 weeks|||mmHg||Standard Deviation|Mean
688649|NCT01464788|Primary|Number of Participants With Symptomatic Intracranial Hemorrhage Within 48 Hours of tPA Administration|Symptomatic intracranial hemorrhage (sICH) is defined as any evidence of bleeding on CT scan that in the opinion of the treating physician and/or an independent safety monitor is associated with a clinically significant neurological worsening. A four or more point increase in the NIHSS score from baseline (or last score obtained prior to blood found on CT scan) to subsequent CT scan at the time of potential worsening can be used as a guide by the clinical investigator or safety monitor for what represents a significant worsening in neurologic status but sICH can include any worsening deemed significant by the clinical investigator or independent safety monitor.|48-hours|One patient in the high dose group did not receive Argatroban and another in the high dose group was lost to follow up; however, an intention-to-treat analysis was used and all 31 enrolled patients were included.||participants|||Number
688650|NCT01464788|Primary|Number of Participants With 0 or 1 on Modified Rankin Scale|Excellent functional outcome as measured by the number of patients with a 0 or 1 on the modified Rankin Scale (mRS) at day 90 as assessed by study personnel blinded to treatment.|90 days|One patient in the high dose group did not receive Argatroban and another in the high dose group was lost to follow up; however, an intention-to-treat analysis was used and all 31 enrolled patients were included.||participants|||Number
688651|NCT01464619|Secondary|Change in Parenting Discipline|Change from baseline to follow-up of the Parenting Scale (PS), a validated self-report measure of parents' self-reported parenting discipline. Total scores range from 1 to 7 with lower scores indicating better parenting discipline.|3 months|||units on a scale||Standard Deviation|Mean
688652|NCT01464619|Secondary|Change in Social Support|Change from baseline to follow-up of the Multidimensional Scale of Perceived Social Support (MSPSS), a validated self-report measure of perceived social support from family, friends, and a significant other. Total scores range from 12 to 84 with higher scores indicating greater perceived social support.|3 months|||units on a scale||Standard Deviation|Mean
688653|NCT01464619|Secondary|Change in Parenting Stress|Change from baseline to follow-up of the Parenting Stress Index-Short Form Total (PSI-SF), a validated self-report measure of parenting stress. Total scores range from 36 to 180 with higher scores indicating greater levels of parenting stress.|3 months|||units on a scale||Standard Deviation|Mean
688654|NCT01464619|Secondary|Feasibility of a Parent Coaching Intervention Incredible Years (IY) That Has Been Adapted for Depressed Caregivers.|Feasibility of the parent coaching intervention will be assessed by the proportion of participants who attended at least 1 session of IY.|3 months|||participants|||Number
688655|NCT01464619|Secondary|Attendance at 6 or More Incredible Years (IY) Sessions|Feasibility of the parent coaching intervention will be assessed by the proportion of participants who attended at least 6 sessions of IY.|3 months|||percentage of subjects enrolled|||Number
688656|NCT01464619|Secondary|Acceptability of the Parent Coaching Intervention|"Acceptability of the parent coaching intervention will be assessed by a response to the question How did you like the parenting program? at the conclusion of the parent sessions. the responses ranged from 1 (highly disliked) to 5 (highly liked)"|3 months|No satisfaction measures were collected from the control group, as they received the intervention in a delayed format after their study participation had ended.||units on a scale||Standard Deviation|Mean
688657|NCT01464619|Secondary|Change in Caregiver Depressive Symptoms|Change from baseline to follow-up of the Beck Depression Scale-II (BDI-II), a validated self-report measure of depressive symptoms. The scale range is from 0 to 63 with higher scores indicating worse depressive symptoms.|3 months|||units on a scale||Standard Deviation|Mean
688658|NCT01464619|Primary|Feasibility of a Parent Coaching Intervention|Feasibility of the parent coaching intervention will be assessed by the proportion of participants who attended at least 10 sessions of Incredible Years over 3 months.|3 months|Original number who enrolled and were assigned to each group.||participants|||Number
688659|NCT01464424|Primary|Overall Mean Intraocular Pressure (IOP)|IOP was measured at three after office hour evaluation time points (4 pm, 6 pm, and 8 pm) for an overall mean. The three timepoints correspond to 20, 22, and 24 hours post dose. Efficacy analysis was performed for one eye only, i.e., the designated study eye. Per-protocol dataset was pre-specified for this non-inferiority analysis.|Week 6|Per protocol: All subjects who received study medication, completed all study visits as per the protocol timelines and criteria, and satisfied inclusion/exclusion criteria.||millimeters mercury (mmHg)||Standard Deviation|Mean
688660|NCT01464424|Secondary|Mean IOP at Each After Office Hour Evaluation Timepoint|IOP was measured at three after office hour evaluation time points (4 pm, 6 pm, and 8 pm). The three timepoints correspond to 20, 22, and 24 hours post dose. Efficacy analysis was performed for one eye only, i.e., the designated study eye.|Week 6: 4 pm, 6 pm, 8 pm|Per protocol: All subjects who received study medication, completed all study visits as per the protocol timelines and criteria, and satisfied inclusion/exclusion criteria.||millimeters mercury (mmHg)||Standard Deviation|Mean
688661|NCT01464359|Secondary|Clinical Disease Response|Defined as leukemia clearance and complete remission. Patients will be followed for disease response for 2 years from transplantation unless: consent is withdrawal, patient is unevaluable - if a patient is not evaluable, follow only untilthe resolution or stabilization of treatment related toxicity, new anti-cancer treatment is started, patient is discharged to hospice (terminal) care.|2 Years from Transplantation|||Participants|||Count of Participants
688662|NCT01464359|Secondary|Duration of Survival||2 years after Transplantation.|||Participants|||Count of Participants
688663|NCT01464359|Secondary|Duration of Survival||1 year after Transplantation.|||Participants|||Count of Participants
688664|NCT01464359|Secondary|Duration of Survival||6 months after Transplantation.|||Participants|||Count of Participants
688665|NCT01464359|Secondary|Clinical Disease Response|Defined as leukemia clearance and complete remission. Patients will be followed for disease response for 1 year from transplantation unless: consent is withdrawal, patient is unevaluable - if a patient is not evaluable, follow only until the resolution or stabilization of treatment related toxicity, new anti-cancer treatment is started, patient is discharged to hospice (terminal) care.|1 Year from Transplantation|||Participants|||Count of Participants
688666|NCT01464359|Secondary|Transplant-Related Mortality||Day 180 after Transplantation|||Participants|||Count of Participants
688667|NCT01464359|Secondary|Incidence of Acute Graft-Versus-Host Disease||Day 60|||Participants|||Count of Participants
699134|NCT01348139|Primary|Emax: Maximum Value of FEV1 for Every Treatment Visits|Peak effect (Emax) within 0-24 hours of FEV1, for treatment visits 2 to 7.|0-24 hrs|||Liters||Standard Deviation|Mean
688669|NCT01464359|Primary|Disease Free Survival|The primary endpoint is a disease free survival at 3 months in patients with chemotherapy refractory AML after a double T-cell depleted (TCD) umbilical cord blood (UCB) transplantation where one TCD unit is activated overnight in IL-2 followed by the administration of two courses of IL-2 three times a week for 6 doses beginning on day +3 and on day +60 to expand UCB-derived NK cells in vivo.|At 3 months|||participants|||Number
688670|NCT01464307|Secondary|Ashworth Scale (AS) for Plantar Flexors at All Post-Baseline Visits|The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Here, ‘n’ specifies those subjects who were evaluated for this outcome measure at given time point.|Baseline, Week 4, 8, and 12|The Full Analysis Set (FAS) included subjects in the Safety Evaluation Set (SES) of the main period for whom the primary efficacy variable was available, whereby SES is the subset of all subjects who were exposed to IP in the main period at least once.||Units on a scale||Standard Deviation|Mean
688671|NCT01464307|Secondary|Response Rate for Plantar Flexors at All Post-Baseline Visits for Subjects With an Improvement (Reduction) of at Least 1 Point From Baseline in the Ashworth Scale (AS)|Response is defined as an improvement (reduction) of the plantar flexor Ashworth Score by at least one score point. The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|Week 4, 8, and 12|"The FAS included subjects in SES of main period for whom primary efficacy variable was available, whereby SES is subset of all subjects who were exposed to IP in main period at least once. Here, “N”(Number of Participants Analyzed) and n signifies those participants who were evaluable for this outcome measure and at given time point respectively."||Percentage of Participants|||Number
688672|NCT01464307|Primary|Co-primary Variable: Investigator's Global Assessment of Efficacy at Week 12|A 4-point Likert scale will be used with the ratings 1 = very good, 2 = good, 3 = moderate, and 4 = poor. Investigator's Global Assessment of Efficacy at Week 12 will be a co-primary outcome measure to fulfill post marketing commitments for U.S. regulatory authorities only. Elsewhere, it will be a secondary outcome measure.|Baseline to Week 12|The Full Analysis Set (FAS) included subjects in the Safety Evaluation Set (SES) of the main period for whom the primary efficacy variable was available, whereby SES is the subset of all subjects who were exposed to IP in the main period at least once.||Percentage of Participants|||Number
688673|NCT01464307|Primary|Change From Baseline in Ashworth Scale (AS) for Plantar Flexors at Week 4|The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|Baseline and Week 4|The Full Analysis Set (FAS) included subjects in the Safety Evaluation Set (SES) of the main period for whom the primary efficacy variable was available, whereby SES is the subset of all subjects who were exposed to IP in the main period at least once.||Units on a scale||Standard Deviation|Mean
688674|NCT01464255|Primary|Lens Fit – Post-Blink Lens Movement Prior to Removal|The ophthalmologist’s objective assessment of lens fit measurement of post-blink lens movement prior to removal of Pair #1 (measured at 7 days after baseline visit) and Pair #2 (measured at 14 days after baseline visit). (mm).|7 days and 14 days from baseline visit|Of 49 total participants, 49 wore pair #1 and 49 crossed over to wear pair #2||mm||Standard Deviation|Mean
688675|NCT01464255|Primary|Lens Fit – Post-Blink Lens Movement After Insertion|The ophthalmologist’s objective assessment of lens fit measurement of post-blink lens movement after insertion (20 minutes settling) of Pair #1 (measured at baseline visit) and Pair #2 (measured at 7 days after baseline visit). (mm).|Baseline and 7 days from baseline visit|Of 49 total participants, 49 wore pair #1 and 49 crossed over to wear pair #2||mm||Standard Deviation|Mean
688676|NCT01464255|Secondary|Overall Lens Pair Preference|Participant’s subjective rating for overall preference for lens pair #1 or Pair #2 based on comfort, vision and handling. Surveyed at 14 days after baseline visit. (Each pair worn for one week daily disposable wear basis, at least 8 hours per day, 7 days per week). Rated by Likert scale, (forced choices – Strongly Prefer New Lenses (Week 2), Slightly Prefer New Lenses (Week 2), No Preference, Slightly Prefer Previous Lenses (Week 1), Strongly Prefer Previous Lenses (Week 1). Reported as Strongly Prefer Test Lenses, Slightly Prefer Test Lenses, No Preference, Slightly Prefer Control Lenses, Strongly Prefer Control Lenses.|14 days from baseline visit|||percentage of participants|||Number
688677|NCT01464255|Secondary|Overall Preference – Handling, Removing|Participant’s subjective rating for overall preference of lens ease of handling at removing for lens pair #1 or Pair #2. Surveyed at 14 days after baseline visit. (Each pair worn for one week daily disposable wear basis, at least 8 hours per day, 7 days per week). Rated by Likert scale, (forced choices – Strongly Prefer New Lenses (Week 2), Slightly Prefer New Lenses (Week 2), No Preference, Slightly Prefer Previous Lenses (Week 1), Strongly Prefer Previous Lenses (Week 1). Reported as Strongly Prefer Test Lenses, Slightly Prefer Test Lenses, No Preference, Slightly Prefer Control Lenses, Strongly Prefer Control Lenses.|14 days from baseline visit|||percentage of participants|||Number
688678|NCT01464255|Secondary|Overall Preference – Handling, Inserting|Participant’s subjective rating for overall preference of lens ease of handling at inserting for lens pair #1 or Pair #2. Surveyed at 14 days after baseline visit. (Each pair worn for one week daily disposable wear basis, at least 8 hours per day, 7 days per week). Rated by Likert scale, (forced choices – Strongly Prefer New Lenses (Week 2), Slightly Prefer New Lenses (Week 2), No Preference, Slightly Prefer Previous Lenses (Week 1), Strongly Prefer Previous Lenses (Week 1). Reported as Strongly Prefer Test Lenses, Slightly Prefer Test Lenses, No Preference, Slightly Prefer Control Lenses, Strongly Prefer Control Lenses.|14 days from baseline visit|||percentage of participants|||Number
688734|NCT01463007|Primary|Early and Intermediate Toxicity|Any toxicity related to the radiation treatment will be scored and graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 (Appendix 4). Acute side effects are any side effects occurring within 3 months of treatment. Intermediate side effects are any side effects occurring between 3 months and 2 years. This is reported in the outcome table.|2 years|||participants|||Number
688679|NCT01464255|Secondary|Overall Preference – Dryness Before Removal|Participant’s subjective rating for overall preference of lens dryness immediately before removal for lens pair #1 or Pair #2. Surveyed at 14 days after baseline visit. (Each pair worn for one week daily disposable wear basis, at least 8 hours per day, 7 days per week). Rated by Likert scale, (forced choices – Strongly Prefer New Lenses (Week 2), Slightly Prefer New Lenses (Week 2), No Preference, Slightly Prefer Previous Lenses (Week 1), Strongly Prefer Previous Lenses (Week 1). Reported as Strongly Prefer Test Lenses, Slightly Prefer Test Lenses, No Preference, Slightly Prefer Control Lenses, Strongly Prefer Control Lenses.|14 days from baseline visit|||percentage of participants|||Number
688680|NCT01464255|Secondary|Overall Preference – Dryness After Insertion|Participant’s subjective rating for overall preference of lens dryness immediately after insertion for lens pair #1 or Pair #2. Surveyed at 14 days after baseline visit. (Each pair worn for one week daily disposable wear basis, at least 8 hours per day, 7 days per week). Rated by Likert scale, (forced choices – Strongly Prefer New Lenses (Week 2), Slightly Prefer New Lenses (Week 2), No Preference, Slightly Prefer Previous Lenses (Week 1), Strongly Prefer Previous Lenses (Week 1). Reported as Strongly Prefer Test Lenses, Slightly Prefer Test Lenses, No Preference, Slightly Prefer Control Lenses, Strongly Prefer Control Lenses.|14 days from baseline visit|||percentage of participants|||Number
688681|NCT01464255|Secondary|Overall Preference – Comfort Before Removal|Participant’s subjective rating for overall preference of lens comfort immediately before removal for lens pair #1 or Pair #2. Surveyed at 14 days after baseline visit. (Each pair worn for one week daily disposable wear basis, at least 8 hours per day, 7 days per week). Rated by Likert scale, (forced choices – Strongly Prefer New Lenses (Week 2), Slightly Prefer New Lenses (Week 2), No Preference, Slightly Prefer Previous Lenses (Week 1), Strongly Prefer Previous Lenses (Week 1). Reported as Strongly Prefer Test Lenses, Slightly Prefer Test Lenses, No Preference, Slightly Prefer Control Lenses, Strongly Prefer Control Lenses.|14 days from baseline visit|||percentage of participants|||Number
688682|NCT01464255|Secondary|Overall Preference – Comfort After Insertion|Participant’s subjective rating for overall preference of lens comfort immediately after insertion for lens pair #1 or Pair #2. Surveyed at 14 days after baseline visit. (Each pair worn for one week daily disposable wear basis, at least 8 hours per day, 7 days per week). Rated by Likert scale, (forced choices – Strongly Prefer New Lenses (Week 2), Slightly Prefer New Lenses (Week 2), No Preference, Slightly Prefer Previous Lenses (Week 1), Strongly Prefer Previous Lenses (Week 1). Reported as Strongly Prefer Test Lenses, Slightly Prefer Test Lenses, No Preference, Slightly Prefer Control Lenses, Strongly Prefer Control Lenses.|14 days from baseline visit|||percentage of participants|||Number
688683|NCT01464255|Primary|Lens Fit – Tightness at One Week|The ophthalmologist’s rating of lens fit measurement of push-up tightness of Pair #1 (measured at 7 days after baseline visit) and Pair #2 (measured at 14 days after baseline visit). Each pair worn for one week daily disposable wear basis (at least 8 hours per day, 7 days per week). Lenses worn minimum 2 hours prior to visit. (0-100%, 5% steps, 0%=excessively loose, 50%=optimum, 100%=excessively tight ).|7 days and 14 days from baseline visit|Of 49 total participants, 49 wore pair #1 and 49 crossed over to wear pair #2||percentage of tightness||Standard Deviation|Mean
688684|NCT01464255|Primary|Lens Fit – Tightness After Insertion|The ophthalmologist’s rating of lens fit measurement of push-up tightness after insertion (20 minutes settling) of Pair #1 (measured at baseline visit) and Pair #2 (measured at 7 days after baseline visit). (0-100%, 5% steps, 0%=excessively loose, 50%=optimum, 100%=excessively tight ).|Baseline and 7 days from baseline visit|Of 49 total participants, 49 wore pair #1 and 49 crossed over to wear pair #2||percentage of tightness||Standard Deviation|Mean
688685|NCT01464255|Primary|Lens Fit – Decentration at One Week|The ophthalmologist’s objective assessment of lens fit measurement of decentration of Pair #1 (measured at 7 days after baseline visit) and Pair #2 (measured at 14 days after baseline visit). Each pair worn for one week daily disposable wear basis (at least 8 hours per day, 7 days per week). Lenses worn minimum 2 hours prior to visit. (mm, horizontal and vertical).|7 days and 14 days from baseline visit|Of 49 total participants, 49 wore pair #1 and 49 crossed over to wear pair #2||mm||Standard Deviation|Mean
688686|NCT01464255|Primary|Lens Fit – Decentration After Insertion|The ophthalmologist’s objective assessment of lens fit measurement of decentration after insertion (20 minutes settling) of Pair #1 (measured at baseline visit) and Pair #2 (measured at 7 days after baseline visit). (mm, horizontal and vertical).|Baseline and 7 days from baseline visit|Of 49 total participants, 49 wore pair #1 and 49 crossed over to wear pair #2||mm||Standard Deviation|Mean
688687|NCT01464229|Primary|SQ Anger/Hostility Scale|"Of the 20 patients randomized, data was analyzed for 13 completers. Symptom Questionnaire (SQ) Anger/Hostility Scale; this is a 23-item subscale of the 92-item Symptom Questionnaire.
This score ranges from 0 to 23; higher values represent higher anger and hostility."|9 weeks|||Score on Anger/Hostility Scale||Standard Deviation|Mean
688688|NCT01464190|Primary|Change From Baseline and Levels at Each Time Point for Serum Intact Parathyroid Hormone (iPTH)|Endpoint is Week 28 or the latest available measurement after baseline when Week 28 data is missing.|Every 4 weeks from baseline to Week 28|For the Primary Outcome, data from the Full Analysis Set for PA-CL-05B (FAS5B) was used. The FAS5B consists of all subjects who enrolled in PA-CL-05B, received at least 1 dose of PA-CL-05B medication, and had at least 1 efficacy assessment after the PA-CL-05B study entry visit.||pg/mL||Standard Deviation|Mean
688689|NCT01464190|Primary|Change From Baseline and Levels at Each Time Point for Serum Calcium|Endpoint is Week 28 or the latest available measurement after baseline when Week 28 data is missing.|Every 4 weeks from baseline to Week 28|For the Primary Outcome, data from the Full Analysis Set for PA-CL-05B (FAS5B) was used. The FAS5B consists of all subjects who enrolled in PA-CL-05B, received at least 1 dose of PA-CL-05B medication, and had at least 1 efficacy assessment after the PA-CL-05B study entry visit.||mg/dL||Standard Deviation|Mean
688690|NCT01464190|Primary|Change From Baseline and Levels at Each Time Point for Serum Phosphorus|Endpoint is Week 28 or the latest available measurement after baseline when Week 28 data is missing.|Every 4 weeks from baseline to Week 28|For the Primary Outcome, data from the Full Analysis Set for PA-CL-05B (FAS5B) was used. The FAS5B consists of all subjects who enrolled in PA-CL-05B, received at least 1 dose of PA-CL-05B medication, and had at least 1 efficacy assessment after the PA-CL-05B study entry visit.||mg/dL||Standard Deviation|Mean
689072|NCT01459705|Secondary|Subjective Units of Distress (SUDs)|Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.|Treatment session 10 (week 5)||||||
688691|NCT01464021|Secondary|Percent Change From Baseline in Health Assessment Questionnaire – Disability Index (HAQ-DI)|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3).|Weeks 4, 8, 12, 26|Participants who received at least one injection of adalimumab and have the necessary clinical data available.||percent change||Standard Deviation|Mean
688692|NCT01464021|Secondary|Percent Change From Baseline in Physician’s Global Assessment of RA Disease Activity|A horizontal VAS (100 mm) measure of the physician's global assessment of the participant’s current RA disease activity, ranging from 0 mm (very good condition) to 100 mm (very bad condition).|Weeks 4, 8, 12, 26|Participants who received at least one injection of adalimumab and have the necessary clinical data available.||percent change||Standard Deviation|Mean
688693|NCT01464021|Secondary|Percent Change From Baseline in Patient’s Assessment of Pain|A horizontal VAS (100 mm) measure of the participant's assessment of RA pain, where the participant was asked to place a vertical mark on the line to indicate how much pain they have had due to RA in the past week, ranging from 0 mm (no pain) to 100 mm (pain as bad as it could be).|Weeks 4, 8, 12, 26|Participants who received at least one injection of adalimumab and have the necessary clinical data available.||percent change||Standard Deviation|Mean
688694|NCT01464021|Secondary|Percent Change From Baseline in Patient’s Global Assessment of Disease Activity|A horizontal Visual Analog Scale (VAS) (100 mm) measure of the participant's global assessment of RA disease activity, where the participant was asked to place a vertical mark on the line to indicate how well their RA has been within the last 24 hours, ranging from 0 mm (very well) to 100 mm (very poorly).|Weeks 4, 8, 12, 26|Participants who received at least one injection of adalimumab and have the necessary clinical data available.||percent change||Standard Deviation|Mean
688695|NCT01464021|Secondary|Percent Change From Baseline in Erythrocyte Sedimentation Rate (ESR)|Rate at which red blood cells sediment in a period of 1 hour, a non-specific measure of inflammation; a higher rate = more inflammation.|Weeks 4, 8, 12, 26|Participants who received at least one injection of adalimumab and have the necessary clinical data available.||percent change||Standard Deviation|Mean
688696|NCT01464021|Secondary|Percent Change From Baseline in C-reactive Protein|C-reactive protein level in serum (mg/dL)|Weeks 4, 8, 12, 26|Participants who received at least one injection of adalimumab and have the necessary clinical data available.||percent change||Standard Deviation|Mean
688697|NCT01464021|Secondary|Percent Change From Baseline in Tender and Swollen Joint Counts|Change in number of tender joints and swollen joints for 28 assessed joints.|Weeks 4, 8, 12, 26|Participants who received at least one injection of adalimumab and have the necessary clinical data available.||Percent change||Standard Deviation|Mean
688698|NCT01464021|Secondary|Percent Change From Baseline in Disease Activity Score (DAS)28 Erythrocyte Sedimentation Rate (ESR)|The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR), and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score > 5.1 indicates high disease activity, ≤ 5.1 indicates moderate disease activity, ≤ 3.2 indicates low disease activity, and ≤ 2.6 indicates clinical remission.|Weeks 4, 8, 12, 26|Participants who received at least one injection of adalimumab and have the necessary clinical data available||percent change||Standard Deviation|Mean
688699|NCT01464021|Primary|Number of Participants With at Least a Moderate European League Against Rheumatism (EULAR) Response|"A EULAR response reflects improvement in disease activity and attainment of a lower degree of disease activity based on the Disease Activity Score (DAS)28 score. The DAS28 score ranges from 0-10, with higher scores indicating more disease activity.
A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score of less than or equal to 3.2.
A Moderate Response is defined as either:
an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 from Baseline and attainment of a DAS28 score of less than or equal to 5.1 or, an improvement (decrease) in the DAS28 of more than 1.2 from Baseline and attainment of a DAS28 score of greater than 3.2.
No Response is defined as either an improvement (decrease) in the DAS28 of less than or equal to 0.6, or an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 of more than 5.1"|Week 12|Participants who received at least 6 consecutive injections of adalimumab (every other week) and have the necessary clinical data for both the Baseline and the Week 12 visit available.||participants|||Number
688700|NCT01463982|Secondary|Objective Response Rate (ORR), Response Rate (RR) and Disease Control Rate (DCR)|"by RECIST guideline Objective response rate = (Number of subjects with best overall response as confirmed CR or PR / Total number of subjects)*100.
Response rate = (Number of subjects with best overall response as CR or PR / Total number of subjects)*100.
Disease control rate = (Number of subjects with best overall response as confirmed CR or PR or SD / Total number of subjects)*100."|tumor response evaluation can continue to receive the study drug until PD confirmation|||percentage of participants||95% Confidence Interval|Number
688701|NCT01463982|Primary|Dose Limiting Toxicity Assessment and Maximum Tolerated Dose Determination|If Dose Limiting Toxicity(DLT) was not observed in the third subject at a dose level from the first study drug dosing date (Day 1) to the end of Cycle 1(21 days), increase the dose to the next level and enroll subjects; enrollment up to Level 4 was allowed. (NCI-CTCAE version 3.0)|Cycle 1 (21 days)|||percentage of participants||95% Confidence Interval|Number
688702|NCT01463878|Secondary|Quadriceps Muscle Volume|The quadriceps muscle volume will be estimated by 2-dimensional ultrasound imaging at enrollment and at the end of the study period (when the patient is being transferred from the ICU or no longer receiving tube feeds). The change in muscle mass during the ICU stay will be compared between the control and intervention groups.|First versus last measurment in ICU. Up to 14 days (average 7 days)||||||
688715|NCT01463384|Primary|Hippocampal Volumes Measured in Three Groups: Alzheimer Disease (AD), Mild Cognitive Impairment (MCI) and Normal, Age-matched Controls (NC).|"Using magnetic resonance images acquired, hippocampal volume was measured monthly for 6 months.
Normal range for hippocampal volume in aged-matched controls is 6.6 - 8.8 cm^3.
Values are reported below for Baseline, averaged for 1-3 months, and averaged for 4-6 months during minocycline administration."|Baseline values, 1-3 Months Values (averaged), 4-6 Months Values (averaged)|||cm^3||Standard Deviation|Mean
688703|NCT01463878|Primary|Glycemic Variability|The patients blood glucose levels will be monitored with a continuous blood glucose monitor which records the calibrated blood glucose level every minute. The mean blood glucose over the patients entire ICU stay (up to 14 days) as well as the mathematical variation (fluctuation) in blood glucose levels will be calculated. The degree of glycemic variation will be assessed by a number of mathematical formula, including mean amplitude of glycemic excursions (MAGE). These parameters will be compared between the control and intervention groups.|Entire ICU stay. Up to 14 days in the ICU (average about 7 days)|||mg/dl (MAGE)||Standard Deviation|Mean
688704|NCT01463696|Secondary|AUC at Time of Last Sample (AUClast) for MK-8242|PK plasma samples were to be collected at the following time points: 0, 0.5, 1, 2, 4, 6, 8 and 12 hours after the first dose on Day 1; and 0, 0.5, 1, 2, 4, 6, 8, 12, 24 (Day 8) and 48 (Day 9) hours post-dose on Day 7.|Cycle 1, Day 1 pre-dose and through 12 hours post dose; Cycle 1 Day 7 pre-dose and through 48 hours post dose|The APaT population consisted of all participants who received at least one dose of study drug.||hr*nM||Geometric Coefficient of Variation|Geometric Mean
688705|NCT01463696|Secondary|Area Under the Concentration Time Curve From Hour 0 to Hour 12 (AUC0-12) for MK-8242|PK plasma samples were to be collected at the following time points: 0, 0.5, 1, 2, 4, 6, 8 and 12 hours after the first dose on Day 1; and 0, 0.5, 1, 2, 4, 6, 8, 12, 24 (Day 8) and 48 (Day 9) hours post-dose on Day 7.|Cycle 1, Day 1 and Day 7, Hour 0 through Hour 12|The APaT population consisted of all participants who received at least one dose of study drug.||hr*nM||Geometric Coefficient of Variation|Geometric Mean
688706|NCT01463696|Secondary|Time to Maximum Plasma Concentration (Tmax) of MK-8242|PK plasma samples were to be collected at the following time points: 0, 0.5, 1, 2, 4, 6, 8 and 12 hours after the first dose on Day 1; and 0, 0.5, 1, 2, 4, 6, 8, 12, 24 (Day 8) and 48 (Day 9) hours post-dose on Day 7.|Cycle 1, Day 1 pre-dose and through 12 hours postdose; Cycle 1 Day 7 pre-dose and through 48 hours post dose|The APaT population consisted of all participants who received at least one dose of study drug.||Hours||Full Range|Median
688707|NCT01463696|Secondary|Maximum Observed Plasma Concentration (Cmax) of MK-8242|PK plasma samples were to be collected at the following time points: 0, 0.5, 1, 2, 4, 6, 8,and 12 hours after the first dose on Day 1; and 0, 0.5, 1, 2, 4, 6, 8, 12, 24 (Day 8) and 48 (Day 9) hours post-dose on Day 7.|Cycle 1, Day 1 pre-dose and through 24 hours post dose; Cycle 1 Day 7 pre-dose and through 48 hours post dose|The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.||nM||Geometric Coefficient of Variation|Geometric Mean
688708|NCT01463696|Primary|Number of Participants With Dose Limiting Toxicities (DLTs)|DLT was defined as: any drug-related hematologic toxicity ≥ Grade 3 lasting ≥1 week, ≥ Grade 3 thrombocytopenia with bleeding, ≥ Grade 3 neutropenia with infection OR non-hematologic DLTs that were any Grade 3, 4, or 5 toxicity with the following exceptions/clarifications: 1) Grade 3 nausea, vomiting, diarrhea, and dehydration were excluded from the determination of DLT if, in the opinion of the investigator and sponsor, they occurred in a setting of inadequate treatment, 2) Grade 3 nausea, vomiting, diarrhea, and dehydration were each considered a DLT if they persisted despite 72 hours of maximal supportive care measures or 3) Any abnormal non-hematological laboratory value ≥ Grade 3 (that is not attributable to any other causes) was considered a DLT only if medical intervention was required to treat the participant, the abnormality led to hospitalization, or the abnormality persisted for ≥1 week.|Cycle 1 (21 days)|The DLT-evaluable population consisted of participants who received at least one dose of MK-8242 and completed Cycle 1 of Part 1 (dose escalation) or the dose confirmation portion of Part 2, or discontinued due to toxicity.||Participants|||Number
688709|NCT01463683|Primary|Percentage of Participants With Pyrexia Adverse Events|Participants were evaluated for pyrexia adverse events using MedDRA version 15.1. Pyrexia (fever) was defined as an oral temperature ≥37.8°C ( ≥100.0°F).|Up to 15 days after each vaccination|All randomized participants who received at least 1 vaccination were included in the analysis||Percentage of participants|||Number
688710|NCT01463683|Primary|Percentage of Participants With Injection-site Adverse Events|Participants were evaluated for injection-site adverse events using MedDRA version 15.1|Up to 15 days after each vaccination|All randomized participants who received at least 1 vaccination were included in the analysis||Percentage of participants|||Number
688711|NCT01463683|Primary|Percentage of Participants Receiving Subcutaneous Vaccination Who Achieved Seroprotection|Blood samples were collected for anti-hepatitis B antibody assays. Seroprotection was defined as ≥10 mIU/mL anti-hepatitis B antibody.|Month 7|The per protocol population consisted of all randomized participants who met enrollment criteria, did not violate the protocol, were seronegative at Baseline, and had vaccination and blood collection. Seroprotection was evaluated only for participants receiving vaccine subcutaneously; intramuscular vaccination was evaluated for safety only.||Percentage of participants|||Number
688714|NCT01463384|Primary|Biomarker NAA/mI Measured in Three Groups: Alzheimer Disease (AD), Mild Cognitive Impairment (MCI) and Normal, Age-matched Controls (NC)|"It has been demonstrated in numerous studies over the past decade that magnetic resonance spectroscopy (MRS) can be used for the diagnosis of Alzheimer’s disease. By measuring an area within the posterior cingulate gyrus, one can obtain a biochemical signature of that region in AD whereby NAA is reduced and mI is increased.
These two biomarkers, N-acetylaspartate (NAA, a neuronal marker) and myo-inositol (mI, a glial marker) were quantified and then used to calculate NAA/mI (an index currently widely used for AD and MCI diagnosis).
Scale of MRS biomarkers for aged-matched controls: NAA = 1.43, mI = 0.60, NAA/mI = 2.38. Any value lower than NAA/mI of 2.38 are considered not normal.
Values are reported below for Baseline, averaged for 1-3 months, and averaged for 4-6 months during minocycline administration."|Baseline values, 1-3 Months Values (averaged), 4-6 Months Values (averaged)|||Ratio||Standard Deviation|Mean
688733|NCT01463007|Secondary|Cosmetic Outcome|Cosmetic results will be evaluated at each follow-up visit by the treating radiation oncologist using the Harvard criteria inclusive of discomfort during treatment(Pain), Fatigue and Acute skin reaction. This is reported in the outcome table.|2 years|||participants|||Number
688716|NCT01463384|Primary|Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)|"RBANS is a brief neurocognitive battery with four alternate forms, measuring immediate and delayed memory, attention, language, and visuospatial skills. RBANS was developed as a stand-alone “core” battery for the detection and neurocognitive characterization of dementia and as a brief neurocognitive battery for the detection and tracking of neurocognitive deficits in a variety of disorders. (Reference: http://rbans.com/)
Qualitative Description of Index Scores:
Index Score Classification 130 and above Very Superior 120-129 Superior 110-119 High Average 90-109 Average 80-89 Low Average 70-79 Borderline 69 and below Extremely Low
Psychometric range for RBANS:
AD 0 - 77 MCI 78 - 99 Normal > 100
Range of scores: Minimum = 0, Maximum = 130
Values are reported below for Baseline, averaged for 1-3 months, and averaged for 4-6 months during minocycline administration."|Baseline values, 1-3 Months Values (averaged), 4-6 Months Values (averaged)|||units on a scale||Standard Deviation|Mean
688717|NCT01463293|Secondary|Adverse Event Frequency|All adverse events, regardless of relationship with investigational product, will be reported during the 4-week follow-up period.|4 weeks||||||
688718|NCT01463293|Secondary|Overall Product Satisfaction|At the end of the supplementation period, subjects will be asked to rate their overall satisfaction with the study product’s ability to relieve their constipation symptoms on a 5-point ordinal scale|4 weeks||||||
688719|NCT01463293|Secondary|Stool Consistency|Stool consistency will be rated each day in a diary by using the Bristol Stool Scale Form|4 weeks||||||
688720|NCT01463293|Secondary|Bowel Movement Frequency|Subjects will record the number of defecations per day in a diary.|4 weeks||||||
688721|NCT01463293|Secondary|Adequate Relief of Constipation (Yes/no)|Adequate relief of constipation (yes/no) This (yes/no) questionnaire will be completed at days 0 and 28.|4 weeks||||||
688722|NCT01463293|Secondary|Bowel Function Index|The Bowel Function Index is a 3-question tool that asks subjects if they have experienced adequate relief of constipation symptoms over the past week. The Bowel Function Index will be completed at days 0 and 28.|4 weeks||||||
688723|NCT01463293|Secondary|Patient Assessment of Constipation QoL (PAC-QoL)|The PAC-QoL is a 28-question survey that asks questions on their quality of life.|4 weeks||||||
688724|NCT01463293|Secondary|Patient Assessment of Constipation Symptoms (PAC-SYM)|The PAC-SYM tool asks 12 questions on the symptoms of constipation. Subjects will complete the PAC-SYM at days 0 and 28.|4 weeks||||||
688725|NCT01463293|Primary|Whole Gut Transit Time|The primary endpoint of this clinical trial is whole gut transit time, which will be assessed using abdominal x-rays on days 0 and 28|4 weeks|Only 39 out of the 224 enrolled subjects consumed the radio-opaque markers in line with the protocol. Because of the substantial number of protocol deviations and the lack of sufficient evaluable subjects, no further analyses of the study data were performed. The study appears not to have yielded evaluable data.|||||
688726|NCT01463111|Secondary|Mean Difference in Barratt Impulsiveness Scale, Version 11 (BIS-11) Score|The BIS-11 is a 30 item self-report questionnaire, used to assess three factors of impulsivity: 1). attentional impulsiveness, reflecting a difficulty concentrating or tolerating cognitive complexity, 2). motor impulsiveness, reflecting a tendency to act before thinking, and 3). non-planing impulsiveness, reflecting a lack of forethought about potential consequences. Items are scored on a 4-point scale: Rarely/Never = 1 Occasionally = 2 Often = 3 Almost Always/Always = 4. Attentional impulsivity scores range from 8-32. Motor impulsivity scores range from 11-44. Non-planning impulsivity scores range from 11-44. Total BIS-11 scores range from 30-120. A higher score reflects higher impulsivity across all sub-types.|Baseline, Week 6|Data was analyzed for participants who completed all study visits. Means are age-adjusted.||units on a scale||Standard Error|Mean
688727|NCT01463111|Primary|Change in Procrastination Assessed by the Melbourne Decision Making Questionnaire (MDMQ)|"The MDMQ is a 22-item self report form assessing four different styles of decision making. The procrastination decision-making style involves putting off making decisions. Scores range from 0-10. A higher score indicates that the procrastination decision-making style is used more and is considered a worse score."|Baseline, Week 6|Data was analyzed for participants who completed all study visits. Means are age-adjusted.||units on a scale||Standard Error|Mean
688728|NCT01463111|Primary|Change in Buckpassing Assessed by the Melbourne Decision Making Questionnaire (MDMQ)|"The MDMQ is a 22-item self report form assessing four different styles of decision making. The buckpassing decision-making style represents a tendency to leave decisions to others. Scores range from 0-12. A higher score indicates that the buckpassing decision-making style is used more frequently and represents a worse score."|Baseline, Week 6|Data was analyzed for participants who completed all study visits. Means are age-adjusted.||units on a scale||Standard Error|Mean
688729|NCT01463111|Primary|Change in Hypervigilance Assessed by the Melbourne Decision Making Questionnaire (MDMQ)|"The MDMQ is a 22-item self report form assessing four different styles of decision making. Hypervigilance is marked by hurried, anxious decision-making. Scores range from 0-10. A higher score indicates a worse score and that a hyper-vigilant decision making style is used more frequently."|Baseline, Week 6|Data was analyzed for participants who completed all study visits. Means are age-adjusted.||units on a scale||Standard Error|Mean
688730|NCT01463111|Primary|Change in Vigilance Assessed by the Melbourne Decision Making Questionnaire (MDMQ)|The MDMQ is a 22-item self report form assessing four different styles of decision making. Vigilance is considered the healthy, adaptive, decision-making style, reflecting consideration of an array of outcomes and ultimately rational decision-making. Scores range from 0-12. A higher score indicates that vigilance is used more frequently during decision making. A higher score indicates healthier decision making.|Baseline, Week 6|Data was analyzed for participants who completed all study visits. Means are age-adjusted.||units on a scale||Standard Error|Mean
688731|NCT01463033|Secondary|Adverse Events|The 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy that received levetiracetam 55 mg/kg/day in a b.i.d. were monitored for adverse events through the 30 day treatment period.|30 day treatment period|The 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy that received levetiracetam 55 mg/kg/day in a b.i.d. were monitored for adverse events through the 30 day treatment period. Symptoms reported to be moderate or severe are listed. Adverse events were not monitored for the Observational group.||Events|||Number
688732|NCT01463033|Primary|Post-Traumatic Epilepsy|occurrence of PTE (Post-Traumatic Epilepsy)|2 years|||participants|||Number
694324|NCT01402128|Secondary|Changes in Visceral Adipose Tissue|Visceral adipose tissue was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis||cm^3||Standard Deviation|Mean
688735|NCT01462942|Secondary|Change From Baseline in St. George´s Respiratory Questionnaire (SGRQ) Total Score|SGRQ is a standardised, self-administered tool for measuring impaired health and perceived well-being in respiratory diseases; a validated electronic version of the questionnaire in the relevant validated languages was used in this study The questionnaire contains 50 items divided into three dimensions (Symptoms, Activity and Impact) Each of the three dimensions of the questionnaire is scored separately in the range from 0 to 100: zero (0) score indicating no impairment of quality of life The total SGRQ score ranging from 0 to 100 is a summary score utilising responses to all items calculated using weights attached to each item of the questionnaire Higher scores indicate poorer health and change of 4 units in the SGRQ has been determined to be the threshold for a clinically relevant change in health status|Baseline and Week 24|||Score on a scale||Standard Error|Least Squares Mean
688736|NCT01462942|Secondary|Change in Transition Dyspnoea Index (TDI) Focal Score|Evaluation of dyspnea was performed by an independent interviewer experienced in taking a respiratory history The TDI includes three categories: functional impairment which determines the impact of breathlessness on the ability to perform activities, magnitude of task which determines the type of task that caused breathlessness and magnitude of effort which establishes the level of effort needed to evoke breathlessness Each category ranges from minus three (-3; major deterioration) to plus three (+3; major improvement) including a zero (0) score to indicate 'no change' The three categories are totalled to obtain a focal score (total score) ranging from minus nine (-9), including zero (0), to plus nine (+9) Provision is made for circumstances when dyspnoea could not be rated - if reduction of activities, effort or functional impairment was caused by reasons other than respiratory A change of 1 unit in TDI is used as the criterion for a minimal meaningful improvement|Baseline and Week 24|||Score on a scale||Standard Error|Least Squares Mean
688737|NCT01462942|Primary|Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1)||Baseline and Week 24|||Liters||Standard Error|Least Squares Mean
688738|NCT01462942|Primary|Change From Baseline in 1-hour Morning Post-dose Forced Expiratory Volume in One Second (FEV1)||Baseline and Week 24|ITT Population defined as all randomized patients who took at least one administration of study medication and had a baseline and at least one post-baseline FEV1 assessment||Liters||Standard Error|Least Squares Mean
688739|NCT01462929|Secondary|Change From Baseline in Normalised FEV1 Area Under the Curve Over the 12-h Night-time Period After 6 Weeks of Treatment|Change from baseline in normalised FEV1 area under the curve over the 12-h night-time period (AUC12-24) after 6 weeks of treatment. The normalised AUC were calculated by means of a trapezoidal method, dividing by the corresponding time interval.|Week 6|Intention to treat (ITT) population: patients who took at least 1 dose of Investigational Medicinal Product and had at least a baseline FEV1 assessment and at least one post-baseline FEV1 value||Liters||Standard Error|Least Squares Mean
688740|NCT01462929|Primary|Change From Baseline in Normalised Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve Over the 24-h Period After 6 Weeks of Treatment|Change from baseline in normalised FEV1 area under the curve over the 24-h period immediately after morning Investigational Medicinal Product administration (AUC0-24h ) after 6 weeks on treatment. The normalised AUC were calculated by means of a trapezoidal method, dividing by the corresponding time interval.|Week 6|Intention to treat (ITT) population: patients who took at least 1 dose of Investigational Medicinal Product and had at least a baseline FEV1 assessment and at least one post-baseline FEV1 value||Liters||Standard Error|Least Squares Mean
688741|NCT01462877|Secondary|Change in Serum High Sensitivity C-reactive Protein|Blood tests|Baseline and up to 8 weeks after intervention||||||
688742|NCT01462877|Secondary|Change in Serum Creatinine|Blood tests|Baseline up to 8 weeks after intervention|Safety set||percentage of Creatinine change||Full Range|Median
688743|NCT01462877|Secondary|Change in Serum Creatine Kinase|Blood tests|Baseline up to 8 weeks after intervention|Safety set||percentage of CK change||Full Range|Median
688744|NCT01462877|Secondary|Change in Serum Aspartate Aminotransferase|Blood tests|Baseline up to 8 weeks after intervention|Safety set||percentage of AST change||Full Range|Median
688745|NCT01462877|Secondary|Change in Serum Alanine Aminotransferase|Blood tests|Baseline up to 8 weeks after intervention|Safety set||percentage of ALT change||Full Range|Median
688746|NCT01462877|Secondary|Change in Serum Apolipoprotein B|Blood tests|Baseline up to 8 weeks after intervention|Full analysis set||percentage of apoB change||Standard Deviation|Mean
688747|NCT01462877|Secondary|Change in Serum Apolipoprotein A1|Blood tests|Baseline up to 8 weeks after intervention|Full analysis set||percentage of apoA1 change||Standard Deviation|Mean
688748|NCT01462877|Secondary|Change in Serum Non-high-density Lipoprotein Cholesterol|Blood tests|Baseline up to 8 weeks after intervention|Full analysis set||percentage of Non-HDL-C change||Standard Deviation|Mean
688749|NCT01462877|Secondary|Change in Serum High-density Lipoprotein Cholesterol|Blood tests|Baseline up to 8 weeks after intervention|Full analysis set||percentage of HDL-C change||Standard Deviation|Mean
688750|NCT01462877|Secondary|Change in Serum Low-density Lipoprotein Cholesterol|Blood tests|Baseline up to 8 weeks after intervention|Full analysis set||percentage of LDL-C change||Standard Deviation|Mean
688751|NCT01462877|Secondary|Change in Serum Total Cholesterol|Blood tests|Baseline and up to 8 weeks after intervention|Full analysis set||percentage of TC change||Standard Deviation|Mean
688752|NCT01462877|Primary|Percentage of Triglyceride (TG) Change|Blood tests|Baseline and up to 8 weeks after intervention|Full Analysis Set||percentage of TG change||Standard Deviation|Mean
688753|NCT01462812|Primary|Headache Relief|The primary objective for this study is to compare headache relief (defined as a reduction from moderate [Grade 2] or severe [Grade 3] pain to none [Grade 0] or mild [Grade 1] pain) at 120 minutes following a dose of 20 mg of OPTINOSE SUMATRIPTAN with placebo in the acute treatment of a single migraine attack.|120 Minutes|The full analysis dataset (FAD) will include all subjects who are randomized, receive study medication, and record at least one post-treatment assessment of pain severity. The treatment group assignment will be designated according to treatment received. The FAD will serve as the basis for the efficacy analyses.||participants|||Number
688785|NCT01462357|Secondary|Number of Subjects With Potentially Immune Mediated Diseases (pIMDs)|Note: Results beyond Month 24 will be updated when validated results become available.|From Day 0 to Month 36 (throughout the study period)|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered, on subjects with symptom sheets completed.||Subjects|||Number
688754|NCT01462773|Secondary|Document Any Objective Anti-tumor Responses and Time to Tumor Progression That May Occur in Response to This Treatment Regimen.|"Measure levels of the cell cycle proteins p21 and p27 in PBMCs and tumor biopsies obtained pre-study and during week 4 of Cycle 1 (Day 26).
Conduct histologic evaluations of microvessel density, tumor apoptosis and lymphocytic infiltrates within tumor biopsies obtained pre- and post-study.
Measure plasma levels of bFGF and VEGF over the course of the study.
Monitor the effects of proteasome inhibition on the biological activity of IFN-α within immune cells by measuring Jak-STAT signal transduction in patient PBMCs."|up to 25 weeks|||patients|||Number
688755|NCT01462773|Primary|Determine Dose Limiting Toxicities (DLTs) of VELCADE When Administered in Combination With IFN-α-2b to Patients With Metastatic Malignant Melanoma.|A standard method for the design of this study. Initially, three patients will be treated at a starting dose of VELCADE (1.0 mg/m2). If one of the three patients demonstrates a DLT, then an additional 3 patients will be treated at that dose level. If only one of the six show DLT, then the next cohort of three patients will be entered at the next dose level (1.3 mg/m2). If two or more of the six demonstrate DLT, no further patients will be treated at that dose level. The highest dose level at which less than 2 patients experienced DLT will be expanded to six patients.|up to 25 weeks or until disease progression|||toxicities|||Number
688756|NCT01462695|Primary|Sustained Objective Response Rate|Sustained objective response was defined as a PR (Partial Response: ≥ 50% decrease in the sum of the products of the 2 perpendicular diameters of all target lesions (up to 5), taking as reference the initial baseline measurements) or CR (Complete Response: disappearance of all target lesions) lasting at least 8 weeks.|Up to 5 years|One patient in Stratum A was excluded because the patient did not receive study drug and therefore was not evaluable for response.||percentage of patients||95% Confidence Interval|Number
688757|NCT01462435|Secondary|TOTPAR-48. Total Pain Relief (TOTPAR) Over 0 to 48 Hours|"Pain relief was assessed using a 5-point categorical scale at all assessment time points after time 0. Subjects were asked “How much relief have you had since your starting pain?” with response choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4.
The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. In this way individual scores covering a longer time period were given more weight. The minimum theoretical score is 0 units, which represent no relief from pain (score of 0 on categorical scale) at all time points after time 0. The maximum theoretical score is 192 units, which represents complete relief from pain (score of 4 on a categorical scale) at all time points after time 0."|0 - 48 hours|||units on a scale*hour||Standard Deviation|Mean
688758|NCT01462435|Secondary|TOTPAR-24. Total Pain Relief (TOTPAR) Over 0 to 24 Hours|"Pain relief was assessed using a 5-point categorical scale at all assessment time points after time 0. Subjects were asked “How much relief have you had since your starting pain?” with response choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4.
The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. In this way individual scores covering a longer time period were given more weight. The minimum theoretical score is 0 units, which represent no relief from pain (score of 0 on categorical scale) at all time points after time 0. The maximum theoretical score is 96 units, which represents complete relief from pain (score of 4 on a categorical scale) at all time points after time 0."|0 - 24 hours|||units on a scale*hour||Standard Deviation|Mean
688759|NCT01462435|Secondary|TOTPAR-8. Total Pain Relief (TOTPAR) Over 0 to 8 Hours|"Pain relief was assessed using a 5-point categorical scale at all assessment time points after time 0. Subjects were asked “How much relief have you had since your starting pain?” with response choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4.
The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. In this way individual scores covering a longer time period were given more weight. The minimum theoretical score is 0 units, which represent no relief from pain (score of 0 on categorical scale) at all time points after time 0. The maximum theoretical score is 32 units, which represents complete relief from pain (score of 4 on a categorical scale) at all time points after time 0."|0 - 8 hours|||units on a scale*hour||Standard Deviation|Mean
688760|NCT01462435|Secondary|Total Pain Relief (TOTPAR) Over 0 to 4 Hours. TOTPAR-4.|"Pain relief was assessed using a 5-point categorical scale at all assessment time points after time 0. Subjects were asked “How much relief have you had since your starting pain?” with response choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4.
The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. In this way individual scores covering a longer time period were given more weight.The minimum theoretical score is 0 units, which represent no relief from pain (score of 0 on categorical scale) at all time points after time 0. The maximum theoretical score is 16 units, which represents complete relief from pain (score of 4 on a categorical scale) at all time points after time 0."|0 - 4 hours|||units on a scale*hour||Standard Deviation|Mean
688761|NCT01462435|Secondary|VASSPID-24. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 24 Hours After Trial Entry.|"The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing No Pain and 100 mm representing Worst Possible Pain.
The VAS summed pain intensity difference (VASSPID) is calculated as the sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment."|0 - 24 hours|||mm*hour||Standard Deviation|Mean
688825|NCT01462266|Secondary|Time to Achieve the Fasting Glucose Target|Fasting glucose target 3 consecutive days with a fingerstick glucose of 72 to 100 mg/dL (4.0 - 5.6 mmol/L). This analysis was the Kaplan-Meier estimated 50th percentile of time (days) to first attainment of target.|Up to 24 weeks|FAS population included all randomized participants who took at least one dose of study medication and had at least one post-randomization glycemic goal assessment.||Days to first attainment of target||95% Confidence Interval|Median
688762|NCT01462435|Secondary|VASSPID-8. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 8 Hours After Trial Entry.|"The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing No Pain and 100 mm representing Worst Possible Pain.
The VAS summed pain intensity difference (VASSPID) is calculated as the sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment."|0 - 8 hours|||mm*hour||Standard Deviation|Mean
688763|NCT01462435|Secondary|VASSPID-4. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 4 Hours After Trial Entry.|"The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing No Pain and 100 mm representing Worst Possible Pain.
The VAS summed pain intensity difference (VASSPID) is calculated as the sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment."|0 - 4 hours|||mm*hour||Standard Deviation|Mean
688764|NCT01462435|Primary|The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale From 0 to 48 Hours After Trial Entry (VASSPID-48), ANCOVA Model.|"The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing No Pain and 100 mm representing Worst Possible Pain.
The VAS summed pain intensity difference (VASSPID) is calculated as the sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment."|0 - 48 hours|Intent-to-Treat Population||mm*hour||Standard Deviation|Mean
688765|NCT01462370|Secondary|Number of Participants With a Global Evaluation of Study Medication of Good, Very Good, or Excellent at 24 Hours After the Initial Dose|At 24 hours following the initial dose of study medication, participants were asked to rate their perception of pain control as poor, fair, good, very good, or excellent. The number of participants that reported good, very good, or excellent pain control at 24 hours post initial dose were summed.|24 Hours|The population consisted of all participants that received at least one dose of study treatment and completed the assessment at 24 hours post initial dose of study medication||Participants|||Number
688766|NCT01462370|Secondary|Number of Participants With a Global Evaluation of Study Medication of Good, Very Good, or Excellent at 6 Hours After the Initial Dose|At 6 hours following the initial dose. participants were asked to rate their perception of pain control as poor, fair, good, very good, or excellent. The number of participants that reported good, very good, or excellent pain control at 6 hours post initial dose were summed.|6 hours|The population consisted of all participants that received at least one dose of study treatment and completed the assessment at 6 hours post initial dose of study medication.||Participants|||Number
688767|NCT01462370|Secondary|PR at Up to 24 Hours Following the Initial Dose|PR during the 24 hours following the initial dose is defined as the maximum PR score recorded during the first 24 hours after the initial dose of study medication. PR is evaluated on a scale of 0 to 4, with 0 = no pain relief, 1= a little pain relief, 2 = some pain relief, 3 = a lot of pain relief, and 4 = complete pain relief.|Up to 24 hours|The population consisted of all participants that received at least one dose of study treatment and had at least one PR observation at up to 24 hours post initial dose of study medication.||Score on a Scale||Standard Error|Least Squares Mean
688768|NCT01462370|Secondary|PID at Up to 24 Hours Following the Initial Dose|PID during the 24 hours following the initial dose is defined as the maximum PID score recorded during first 24 hours after the initial dose of study medication. PID is evaluated on a scale from 0 to 3, with 0 = no pain, 1 = slight pain, 2 = moderate pain, and 3 = severe pain.|Baseline and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 20 and 24 hours|The population consisted of all participants that received at least one dose of study treatment and had at least one PID observation up to 24 hours post initial dose of study medication.||Score on a Scale||Standard Error|Least Squares Mean
688769|NCT01462370|Secondary|PR at Up to 12 Hours Following the Initial Dose|PR during the 12 hours following the initial dose is defined as the maximum PR score recorded during the first 12 hours after the initial dose of study medication. PR is evaluated on a scale of 0 to 4, with 0 = no pain relief, 1= a little pain relief, 2 = some pain relief, 3 = a lot of pain relief, and 4 = complete pain relief.|Up to 12 hours|The population consisted of all participants that received at least one dose of study treatment and had at least one PR observation up to 12 hours post initial dose of study medication.||Score on a Scale||Standard Error|Least Squares Mean
688770|NCT01462370|Secondary|PID at Up to 12 Hours Following the Initial Dose|PID during the 12 hours following the initial dose is defined as the maximum PID score recorded during first 12 hours after the initial dose of study medication. PID is evaluated on a scale from 0 to 3, with 0 = no pain, 1 = slight pain, 2 = moderate pain, and 3 = severe pain.|Baseline and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 and 12 hours|The population consisted of all participants that received at least one dose of study treatment and had at least one PID observation at up to 12 hours post initial dose of study medication.||Score on a Scale||Standard Error|Least Squares Mean
688771|NCT01462370|Secondary|Number of Participants Using Rescue Medication 24 Hours After the Initial Dose|Acetaminophen 250 mg, isopropylantipyrine 150 mg and anhydrous caffeine 50 mg (Saridon) was provided to each participant as rescue medication. Participants were permitted to take 2 tablets at a time and up to 3 doses within 24 hours of dosing of study drug for rescue purposes.|24 Hours|Due to the low number of participants requiring rescue medication use, the time to rescue medication use was not calculated.||Participants|||Number
688772|NCT01462370|Secondary|Peak Pain Relief (Peak PR) During the 6 Hours After the Initial Dose|"Peak PR during the 6 hours post initial dose is defined as the maximum PR score
recorded during the first 6 hours after the initial dose of study medication. PR is recorded on a scale of 0 to 4, with 0 = no pain relief, 1 = little pain relief, 2 = some pain relief, 3 = a lot of pain relief, and 4 = complete pain relief."|Up to 6 hours|The population consisted of all participants that received at least one dose of study treatment and had at least one Peak PR observation up to 6 hours post initial dose of study medication.||Score on a Scale||Standard Error|Least Squares Mean
688773|NCT01462370|Secondary|Peak Pain Intensity Difference (PID) During the 6 Hours After the Initial Dose|Peak PID during the 6 hours post initial dose is defined as the maximum PID score recorded during first 6 hours after the initial dose of study medication. PID is evaluated on a scale of -1 to 3, with larger values representing a greater treatment effect.|Baseline and 0.5, 1, 1.5, 2, 3, 4, 5 and 6 hours|The population consisted of all participants that received at least one dose of study treatment and had a PID observation at up to 6 hours post initial dose of study medication.||Score on a Scale||Standard Error|Least Squares Mean
688774|NCT01462370|Secondary|Mean Time to >=1 Unit Improvement From Baseline in Pain Intensity During the 6 Hours After the Initial Dose|The time to a change from baseline in pain intensity score of >=1 unit on the pain intensity scale was calculated. The pain intensity scale rates participant pain on a scale of -1 to 3, with larger values associated with greater treatment effect.|Baseline and 6 hours|The population consisted of all participants that received at least one dose of study treatment, had an observation at 6 hours post initial dose of study medication, and had a baseline measurement.||Hours||95% Confidence Interval|Mean
688775|NCT01462370|Secondary|Mean Participant Global Evaluation of Pain at 24 Hours After the Initial Dose (GLOBAL24)|The GLOBAL24 was recorded by the participant at 24 hours (or at the time of rescue medication use) after taking the first dose of study medication. The GLOBAL24 uses a pain relief scale of 0 to 4, where 0 = poor pain relief, 1 = fair pain relief, 2 = good pain relief, 3 = very good pain relief, and 4 = excellent pain relief.|24 hours|The population consisted of all participants that received at least one dose of study treatment had a GLOBAL24 observation at 24 hours post initial dose of study medication.||Score on a Scale||Standard Error|Least Squares Mean
688776|NCT01462370|Secondary|Mean Participant Global Evaluation of Pain at 6 Hours After the Initial Dose (GLOBAL6)|The GLOBAL6 was recorded by the participant at 6 hours (or at the time of rescue medication use) after taking the first dose of study medication. The GLOBAL6 uses a pain relief scale of 0 to 4, where 0 = poor pain relief, 1 = fair pain relief, 2 = good pain relief, 3 = very good pain relief, and 4 = excellent pain relief.|6 hours|The population consisted of all participants that received at least one dose of study treatment and had a GLOBAL6 observation at 6 hours post initial dose of study medication.||Score on a Scale||Standard Error|Least Squares Mean
688777|NCT01462370|Secondary|Sum of Pain Intensity Difference Scores Over the 6-Hour Time Period (SPID6)|The Pain Intensity Difference (PID) score is the difference between the baseline pain intensity (PI) score and the PI score recorded at each time point post initial dose, as calculated by subtracting the pain intensity at each of the subsequent time points from the baseline pain intensity score; therefore, it is on a -1 to 3 scale, with a large value representing a greater treatment effect. SPID6 is derived by multiplying the PID score at each time point by the duration (in hours) since the preceding time point, and summing these weighted values up to 6 hours and it is on a scale of -6 to 18.|Baseline and 0.5, 1, 1.5, 2, 3, 4, 5 and 6 hours|The population consisted of all participants that received at least one dose of study treatment, had at least one SPID6 observation up to 6 hours post initial dose of study medication, and had a baseline measurement.||Score on a Scale||Standard Error|Least Squares Mean
688778|NCT01462370|Primary|Total Pain Relief Score Over the First 6 Hours (TOPAR6) After the Initial Dose|TOPAR6 was calculated by multiplying the pain relief (PR) score (0- to 4-point scale, with 0=None, and 4=Complete for pain relief) at each time point by the duration (in hours) since the preceding time point, and summing these weighted values up to 6 hours post the initial Day 1 dose. The range of TOPAR6 score is 0 to 24, with increasing scores indicating greater pain relief.|Baseline and 0.5, 1, 1.5, 2, 3, 4, 5 and 6 hours|The population consisted of all participants that received at least one dose of study treatment and had at least one TOPAR6 observation up to 6 hours post initial dose of study medication.||Score on a Scale||Standard Error|Least Squares Mean
688779|NCT01462357|Secondary|Number of Subjects With Pregnancies|Note: No pregnancies were reported up to the Month 36 time point.|Throughout the study period (From Day 0 up to Month 36)|The Total Vaccinated cohort included all subjects with at least one study vaccine administered.||Subjects|||Number
688780|NCT01462357|Secondary|Number of Subjects Completing the Vaccination Schedule|The number of subjects who have completed the three-dose vaccination schedule in all groups.|Throughout the study period (From Day 0 up to Month 36)|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered, on subjects with symptom sheets completed.||Subjects|||Number
688781|NCT01462357|Secondary|Number of Subjects Starting a Concomitant Medication|The outcome presents the number of subjects starting any concomitant medication, as well as any antipyretic, any prophylactic antipyretic and any antibiotic.|From Day 0 to Month 36 (throughout the study period)|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered, on subjects with symptom sheets completed.||Subjects|||Number
688782|NCT01462357|Secondary|Number of Subjects Starting a Concomitant Medication|The outcome presents the number of subjects starting any concomitant medication, as well as any antipyretic, any prophylactic antipyretic and any antibiotic.|During the 30-day (Days 0-29) post-vaccination period|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered, on subjects with symptom sheets completed.||Subjects|||Number
688783|NCT01462357|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Day 0 to Month 36 (throughout the study period)|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered, on subjects with symptom sheets completed.||Subjects|||Number
688784|NCT01462357|Secondary|Number of Subjects With Medically Significant Conditions (MSCs)|MSCs were defined as AEs prompting emergency room (ER) or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs not related to common diseases. Common diseases include: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.|From Day 0 to Month 36 (throughout the study period)|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered, on subjects with symptom sheets completed.||Subjects|||Number
690141|NCT01451398|Secondary|FEV1 Change From Baseline to Week 24|Forced Expiratory Volume in 1 second - change from baseline to week 24|Baseline to Week 24|Full analysis set for patients with data at both Baseline and at Week 24||Liters||Standard Deviation|Mean
688786|NCT01462357|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 30-day period (Days 0-29) post-vaccination|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered, on subjects with symptom sheets completed.||Subjects|||Number
688787|NCT01462357|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, rash, temperature [defined as oral temperature equal to or above 37.5 degrees Celsius (°C)] and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day period (Days 0-6) following vaccination (across doses)|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered, on subjects with symptom sheets completed.||Subjects|||Number
688788|NCT01462357|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimetres (mm) of injection site. Relationship analysis was not performed.|During the 7-day period (Days 0-6) following vaccination (across doses)|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered, on subjects with symptom sheets completed.||Subjects|||Number
688789|NCT01462357|Secondary|B-cell-mediated Immune Responses in the Sub-cohort for CMI|The frequency of B-cell Elispot response to HPV-16/18 by overall status was presented.|At Day 0 and Months 7, 12, 24 and 36|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at the time of the analysis.||B-cells/million cells||Inter-Quartile Range|Median
688790|NCT01462357|Secondary|T-cell-mediated Immune Responses in the Sub-cohort for CMI|Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-γ), Tumour necrosis factor-alpha (TNF-α) and CD40-ligand (CD40-L).|At Day 0 and Months 7, 12, 24 and 36|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at the time of the analysis.||T-cells/million cells||Inter-Quartile Range|Median
688791|NCT01462357|Secondary|Anti-HPV-16/18 Antibody Titers Assessed by PBNA in a Subset of Subjects|Anti-HPV 16/18 antibody titers were presented as geometric mean titers (GMT) and expressed in titers using the PBNA.|At Months 24 and 36|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered, on subjects with symptom sheets completed.||Titers||95% Confidence Interval|Geometric Mean
688792|NCT01462357|Secondary|Anti-HPV-16/18 Seroconversion Rates Assessed by PBNA in a Subset of Subjects|Seroconversion was defined as the appearance of antibodies (i.e. anti-HPV-16 and anti-HPV-18 antibody titers greater than or equal to ≥ 40 ED50) in the serum of subjects seronegative before vaccination in the primary study.|At Months 24 and 36|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered, on subjects with symptom sheets completed.||Subjects|||Number
688793|NCT01462357|Secondary|Anti-HPV-16/18 Antibody Titers Assessed by PBNA in a Subset of Subjects|Anti-HPV 16/18 antibody titers were presented as geometric mean titers (GMT) and expressed in titers using the PBNA.|At Day 0 and Months 7, 12, 18, 24 and 36|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at the time of the analysis.||Titer||95% Confidence Interval|Geometric Mean
688794|NCT01462357|Secondary|Anti-HPV-16/18 Seroconversion Rates Assessed by Pseudovirion-based Neutralization Assay (PBNA) in a Subset of Subjects|Seroconversion was defined as the appearance of antibodies (i.e. anti-HPV-16 and anti-HPV-18 antibody titers respectively greater than or equal to ≥ 40 ED50) in the serum of subjects seronegative before vaccination in the primary study.|At Day 0 and Months 7, 12, 18, 24 and 36|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at the time of the analysis.||Subjects|||Number
688795|NCT01462357|Secondary|Anti-HPV-16/18 Antibody Concentrations Assessed by ELISA|Anti-HPV 16/18 antibody concentrations were presented as geometric mean concentrations (GMC) and expressed in ELISA units per milliliter (EL.U/mL) based on ELISA.|At Day 0 and Months 12, 18, 24 and 36|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at the time of the analysis.||EL.U/mL||95% Confidence Interval|Geometric Mean
688796|NCT01462357|Secondary|Anti-HPV-16/18 Seroconversion Rates Assessed by ELISA|Seroconversion was defined as the appearance of antibodies (i.e. anti-HPV-16 and anti-HPV-18 antibody titers greater than or equal to 19 and 18 EL.U/mL, respectively) in the serum of subjects seronegative before vaccination in the primary study.|At Day 0 and Months 12, 18, 24 and 36|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at the time of the analysis.||Subjects|||Number
688797|NCT01462357|Primary|Anti-HPV-16/18 Antibody Concentrations Assessed by ELISA|"Anti-HPV 16/18 antibody concentrations were presented as geometric mean titers (GMT) and expressed in IU/mL.
Assay cut-offs used for analyses at Month 36 were modified to 3.1 and 3.2 IU/mL respectively, after applying the conversion factor from EL.U/mL to IU/mL."|At Month 36|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at the time of the analysis.||IU/mL||95% Confidence Interval|Geometric Mean
688826|NCT01462266|Secondary|Percent of Participants Achieving Fasting Glucose Target at Any Time During the Study|The fasting glucose target was defined as 3 consecutive days with a fingerstick glucose of 72 to 100 mg/dL (4.0 - 5.6 mmol/L).|Up to 24 weeks|FAS population included all randomized participants who took at least one dose of study medication, and had at least one post-randomization glycemic goal assessment.||Percentage of participants||95% Confidence Interval|Number
688798|NCT01462357|Primary|Anti-HPV-16/18 Seroconversion Rates Assessed by ELISA|"Seroconversion was defined as the appearance of antibodies [i.e. anti-HPV-16 and anti-HPV-18 antibody titers greater than or equal to 3.1 and 3.2 international units per milliliter (IU/mL), respectively], in the serum of subjects who were seronegative before vaccination in the primary study.
The assay cut-offs used for analyses at Month 36 were modified to 3.1 and 3.2 IU/mL, after applying the conversion factor from EL.U/mL to IU/mL."|At Month 36|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at the time of the analysis.||Subjects|||Number
688799|NCT01462357|Primary|Anti-HPV-16/18 Antibody Concentrations Assessed by ELISA|Anti-HPV 16/18 antibody concentrations were presented as geometric mean concentrations (GMC) and expressed in ELISA units per milliliter (EL.U/mL) based on ELISA.|One month after the last dose of study vaccine (Month 7)|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at the time of the analysis.||EL.U/mL||95% Confidence Interval|Geometric Mean
688800|NCT01462357|Primary|Number of Seroconverted Subjects for Anti-HPV-16/18, as Assessed by Enzyme-linked Immunosorbent Assay (ELISA)|Seroconversion was defined as the appearance of antibodies (i.e. anti-HPV-16 and anti-HPV-18 antibody titers greater than or equal to 19 and 18 EL.U/mL, respectively), in the serum of subjects seronegative before vaccination in the primary study.|One month after the last dose of study vaccine (Month 7)|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at the time of the analysis.||Subjects|||Number
688801|NCT01462344|Secondary|Percentage of Asthma Control Days Over the 6-month Study Treatment Period|An asthma control day is one on which rescue albuterol/salbutamol use was recorded as 0, no night time awakenings were recorded, no asthma exacerbations were recorded, no work, school, or daycare days were missed by caregiver or participant due to asthma, coughing symptom score was <=1 and wheezing symptom score was 0. The mean percentages of asthma control days over the months 1-6 (defined as treatment days 2-182) are summarized. Number of participants over treatment days 2-182 from mITT Population were included for this endpoint.|From Day 1 up to 6 months|mITT Population||Percentage of asthma control days||Standard Error|Mean
688802|NCT01462344|Secondary|Percentage of Rescue-free Days Over the 6-month Study Treatment Period|Rescue-free days were days without use of rescue albuterol/salbutamol (other than pre-exercise treatment) over the 6-month study treatment period. The mean percentages of rescue-free days over the months 1-6 (defined as treatment days 2-182) are summarized. Number of participants over treatment days 2-182 from mITT Population were included for this endpoint.|From Day 1 up to 6 months|mITT Population||Percentage of rescue-free days||Standard Error|Mean
688803|NCT01462344|Secondary|Number of Participants Withdrawn From Study Treatment Due to Asthma Exacerbation Over the 6-month Study Treatment Period|An exacerbation is defined as deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days (up to 10 days) or a single depot corticosteroid injection. Number of participants experiencing at least one exacerbation from mITT population were included for this endpoint. The number of participants withdrawn from study treatment due to asthma exacerbation over the 6-month study treatment period are presented.|From Day 1 up to 6 months|mITT Population||Participants|||Number
688804|NCT01462344|Secondary|Number of Participants Experiencing Asthma-related Hospitalizations Over the 6-month Study Treatment Period|Hospitalization is defined as a >=24-hour stay as an inpatient or in an observation ward. The number of participants experiencing asthma-related hospitalizations over the 6-month study treatment period are presented.|From Day 1 up to 6 months|ITT Population||Participants|||Number
688805|NCT01462344|Secondary|Number of Participants Experiencing Asthma-related Endotracheal Intubations Over the 6-month Study Treatment Period|Intubation is defined as endotracheal intubation with ventilation (mechanical or by hand). The number of participants experiencing asthma-related endotracheal intubations over the 6-month study treatment period are presented.|From Day 1 up to 6 months|ITT Population||Participants|||Number
688806|NCT01462344|Secondary|Number of Participants Experiencing Asthma-related Deaths Over the 6-month Study Treatment Period.|Number of participants experiencing asthma-related death over the 6-month study treatment period are presented.|From Day 1 up to 6 months|ITT Population||Participants|||Number
688807|NCT01462344|Primary|Number of Participants With at Least One Asthma Exacerbation Over the 6-month Study Treatment Period|Number of participants with asthma exacerbation over the 6-month study treatment period are presented. Participants from mITT population with screening childhood asthma control test (C-ACT) scores of 20 or higher, one exacerbation in the previous year, and either low-dose inhaled corticosteroid (ICS) + one or more adjunctive therapy or medium-dose ICS monotherapy or medium-dose ICS and one or more adjunctive therapy as prior asthma therapy were included for this endpoint. Time to first exacerbation analyzed using a cox proportional hazards regression model. The number of asthma exacerbations were compared between treatments using a negative binomial regression model. The modified Intent-to-Treat (mITT) Population consisted of the ITT participants with a different data cut-off for supportive analyses of the primary composite safety endpoint.|From Day 1 up to 6 months|mITT Population||Participants|||Number
688808|NCT01462344|Primary|Number of Participants Experiencing an Event in the Composite Safety Endpoint of Serious Asthma Outcomes ( Asthma-related Hospitalization, Asthma-related Endotracheal Intubation, or Asthma-related Death)|Composite endpoint was defined as clinically relevant endpoint that is constructed from combinations of other clinically relevant endpoints of serious asthma outcomes (i.e., asthma-related hospitalization, asthma-related endotracheal intubation, or asthma-related death). Hospitalization was defined as an inpatient stay or a >=24-hour stay in an observation area in an emergency department or other equivalent facility. Time to first event in the composite endpoint of serious asthma-related outcomes over the 6-month study treatment period was analyzed using a Cox proportional hazards regression model. An estimate of absolute risk difference and its corresponding 95% confidence interval (CI) were also included. The Intent-to-Treat (ITT) Population included all participants randomized to study drug and who took study treatment.|From Day 1 up to 6 months|ITT Population||Participants|||Number
688809|NCT01462318|Secondary|TP-DI Sub-study: Omeprazole/Hydroxyomeprazole Concentration Ratio at 2 Hours Post-omeprazole Dosing||Week 43 (7 days prior to DAC HYP administration) and Week 53 (7 days after DAC HYP administration) at 2 hours after probe drug cocktail administration|TP-DI Sub-study population: all participants in the TP-DI substudy who had enough post-baseline measurable drug concentrations to calculate the parameter.||ratio||Standard Deviation|Mean
688810|NCT01462318|Secondary|TP-DI Sub-study: CL/F of Each Probe Drug|CL/F of each of the following CYP isoenzyme substrates: midazolam (CYP3A), warfarin + vitamin K (CYP2C9), and omeprazole (CYP2C19).|Week 43 (7 days prior to DAC HYP administration) and Week 53 (7 days after DAC HYP administration), pre-cocktail dose and at 0.5 and 1, 2, 3, 4, 6, 8, 10 , 24, 48, 72 and 96 hours post-probe drug cocktail administration|TP-DI Sub-study population: all participants in the TP-DI substudy who had enough post-baseline measurable drug concentrations to calculate the parameter; n=participants with an evaluable assessment at given time point.||mL/hr||Standard Deviation|Mean
688811|NCT01462318|Secondary|TP-DI Sub-study: Cmax of Each Probe Drug|Cmax of each of the following CYP isoenzyme substrates: midazolam (CYP3A), caffeine (CYP1A2), warfarin + vitamin K (CYP2C9), and omeprazole (CYP2C19).|Week 43 (7 days prior to DAC HYP administration) and Week 53 (7 days after DAC HYP administration), pre-cocktail dose and at 0.5 and 1, 2, 3, 4, 6, 8, 10 , 24, 48, 72 and 96 hours post-probe drug cocktail administration|TP-DI Substudy population: all participants in the TP-DI substudy who had enough post-baseline measurable drug concentrations to calculate the parameter; n=participants with an evaluable assessment at given time point.||ng/mL||Standard Deviation|Mean
688812|NCT01462318|Secondary|Intensive PK Sub-study: Apparent Clearance (CL/F) of DAC HYP||Day 141 (Week 20) at pre-dose and 8, 24, 72 and 120 hours post-dose and 7, 10, 14 and 21 days post-dose|PK population: all participants who participated in the Intensive PK sub-study and had enough post-study baseline measurable drug concentrations to calculate the parameter.||L/day||Standard Deviation|Mean
688813|NCT01462318|Secondary|Intensive PK Sub-study: Elimination Half-life (t½) of DAC HYP||Day 141 (Week 20) at pre-dose and 8, 24, 72 and 120 hours post-dose and 7, 10, 14 and 21 days post-dose|PK population: all participants who participated in the Intensive PK sub-study and had enough post-study baseline measurable drug concentrations to calculate the parameter.||day||Standard Deviation|Mean
688814|NCT01462318|Secondary|Intensive PK Sub-study: Apparent Volume of Distribution (V/F) of DAC HYP||Day 141 (Week 20) at pre-dose and 8, 24, 72 and 120 hours post-dose and 7, 10, 14 and 21 days post-dose|PK population: all participants who participated in the Intensive PK sub-study and had enough post-study baseline measurable drug concentrations to calculate the parameter.||Liters||Standard Deviation|Mean
688815|NCT01462318|Secondary|Intensive PK Sub-study: Minimum Concentrations (Cmin) of DAC HYP||Day 141 (Week 20) at pre-dose and 8, 24, 72 and 120 hours post-dose and 7, 10, 14 and 21 days post-dose|PK population: all participants who participated in the Intensive PK sub-study and had enough post-study baseline measurable drug concentrations to calculate the parameter.||mcg/mL||Standard Deviation|Mean
688816|NCT01462318|Secondary|Intensive PK Sub-study: Area-Under-the-Curve From Start to End of the Dosing Interval (AUCtau) of DAC HYP||Day 1 and Day 141 (Week 20) at pre-dose and 8, 24, 72, and 120 hours post-dose and 7, 10, 14, and 21 days post-dose|PK population: all participants who participated in the Intensive PK sub-study and had enough post-study baseline measurable drug concentrations to calculate the parameter; n=participants with an assessment at given time point.||day*mcg/mL||Standard Deviation|Mean
688817|NCT01462318|Secondary|Intensive PK Sub-study: Time to Reach Maximum Concentration (Tmax) of DAC HYP||Day 1 and Day 141 (Week 20) at pre-dose and 8, 24, 72, and 120 hours post-dose and 7, 10, 14 and 21 days post-dose|PK population: all participants who participated in the Intensive PK sub-study and had enough post-study baseline measurable drug concentrations to calculate the parameter; n=participants with an assessment at given time point.||day||Standard Deviation|Mean
688818|NCT01462318|Secondary|Intensive PK Sub-study: Cmax of DAC HYP||Day 1 and Day 141 (Week 20) at pre-dose and 8, 24, 72, and 120 hours post-dose and 7, 10, 14 and 21 days post-dose|PK population: all participants who participated in the Intensive PK sub-study and had enough post-study baseline measurable drug concentrations to calculate the parameter; n=participants with an assessment at given time point.||mcg/mL||Standard Deviation|Mean
688819|NCT01462318|Primary|TP-DI Sub-study: Dextromethorphan to Dextrorphan Urine Concentration Ratio||Week 43 (7 days prior to DAC HYP administration) and Week 53 (7 days after DAC HYP administration), pre-cocktail dose and for 12 hours after probe-drug cocktail administration|TP-DI Sub-study population: all participants in the TP-DI substudy who had enough post-baseline measurable drug concentrations to calculate the parameter; n=participants with an evaluable assessment at given time point.||ratio||Standard Deviation|Mean
688820|NCT01462318|Primary|TP-DI Sub-study: Area-Under-the-Curve From Zero to Infinity (AUCinf) of Each Probe Drug|AUCinf of each of the following cytochrome P450 (CYP) isoenzyme substrates: midazolam (CYP3A), S-warfarin + vitamin K (CYP2C9), and omeprazole (CYP2C19). The AUC from zero to 12 hours (AUC0-12) was calculated for caffeine (CYP1A2).|Week 43 (7 days prior to DAC HYP administration) and Week 53 (7 days after DAC HYP administration), pre-cocktail dose and at 0.5 and 1, 2, 3, 4, 6, 8, 10 , 24, 48, 72 and 96 hours post-probe drug cocktail administration|TP-DI Sub-study population: all participants in the TP-DI substudy who had enough post-baseline measurable drug concentrations to calculate the parameter; n=participants with an evaluable assessment at given time point.||hr*ng/mL||Standard Deviation|Mean
688821|NCT01462318|Primary|Number of Participants With Anti-DAC HYP Neutralizing Antibodies (NAbs): ECL ADA Assay|Participants with PB NAbs through Week 44, in the treatment period (extends up to 42 days after the last dose during the main study), and in the post-treatment period (43 days after the last dose until the end of the post-treatment period dose).|Up to 44 weeks|Immunogenicity evaluable population: all participants in the main study population who received at least 1 dose of DAC HYP and had at least 1 post-study baseline immunogenicity assessment; n=participants with an assessment during the given period.||participants|||Number
688822|NCT01462318|Primary|Number of Participants With Anti-DAC HYP Binding Antibodies (ADAbs): Electrochemiluminescent (ECL) Anti-Drug Antibody (ADA) Assay|Participants with post-baseline (PB) ADAbs through Week 44, in the treatment period (extends up to 42 days after the last dose during the main study), and in the post-treatment period (43 days after the last dose until the end of the post-treatment period dose).|Up to 44 weeks|Immunogenicity evaluable population: all participants in the main study population who received at least 1 dose of DAC HYP and had at least 1 post-study baseline immunogenicity assessment; n=participants with an assessment during the given period.||participants|||Number
688823|NCT01462279|Secondary|Improvement in Hemodynamics|Measurements are taken at baseline and are continuously monitored over 9 hours. Thiamine is administered three hours after baseline measurements are taken.|Baseline to Nine Hours||||||
688824|NCT01462279|Primary|Improvement in VO2|VO2 measurements are taken at baseline and VO2 is continuously monitored over 9 hours. Thiamine is administered three hours after baseline measurements are taken.|Baseline to 9 Hours|||ml/min||Standard Deviation|Mean
688827|NCT01462266|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Change in FPG (before breakfast) following 24 weeks of therapy (i.e., FPG at Week 24 minus FPG at baseline)|Baseline and Week 24|FAS population included all randomized participants who took at least one dose of study medication and had at least one measurement either at baseline or post-randomization.||mg/dL||95% Confidence Interval|Least Squares Mean
688828|NCT01462266|Secondary|Change From Baseline in Hemoglobin A1c (A1C) at Week 24|A1C is measured as the percentage of glycosylated hemoglobin. Change in A1C following 24 weeks of therapy (i.e., A1C at Week 24 minus A1C at baseline)|Baseline and Week 24|FAS population included all randomized participants who took at least one dose of study medication and had at least one measurement either at baseline or post-randomization.||Percent of total hemoglobin||95% Confidence Interval|Least Squares Mean
688829|NCT01462266|Primary|Change From Baseline in Daily Insulin Dose at Week 24|Change in daily insulin dose following 24 weeks of therapy (i.e., daily insulin dose at Week 24 minus daily insulin dose at baseline)|Baseline and Week 24|Full Analysis Set (FAS) population included all randomized participants who took at least one dose of study medication and had at least one measurement either at baseline or post-randomization.||International Units (IU)||95% Confidence Interval|Least Squares Mean
688830|NCT01462227|Secondary|Norepinephrine (pg/mL)|Norepinephrine was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study.|End of study (up to 240 minutes)|Subjects' data were pooled and only those that completed both visits are analyzed here.||pg/mL||Standard Deviation|Mean
688831|NCT01462227|Secondary|Epinephrine (pg/mL)|Epinephrine was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study.|End of study (up to 240 minutes)|Subjects' data were pooled and only those that completed both visits are analyzed here.||pg/mL||Standard Deviation|Mean
688832|NCT01462227|Secondary|Cortisol (ug/dL)|Cortisol was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study.|End of study (up to 240 minutes)|Subjects' data were pooled and only those that completed both visits are analyzed here.||ug/dL||Standard Deviation|Mean
688833|NCT01462227|Secondary|Glucagon (pg/mL)|Glucagon was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study.|End of study (up to 240 minutes)|Subjects' data were pooled and only those that completed both visits are analyzed here.||pg/mL||Standard Deviation|Mean
688834|NCT01462227|Primary|Glucose Infusion Rate (mg/kg.Min)|The glucose infusion rate corresponds to the amount of 20% dextrose given during the hyperinsulinemic-hypoglycemic clamp study, necessary to keep blood glucose levels at the target range (50-55 mg/dL).|End of study (up to 240 minutes)|Subjects' data were pooled and only those that completed both visits are analyzed here.||mg/kg.min||Standard Deviation|Mean
688835|NCT01462227|Primary|Glucose (mg/dL)|Glucose was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study.|End of study (up to 240 minutes)|Subjects' data were pooled and only those that completed both visits are analyzed here.||mg/dL||Standard Deviation|Mean
688836|NCT01462162|Secondary|Percentage of Participants Achieving a Response According to European League Against Rheumatism (EULAR) Criteria at Week 12 and 24 - Safety Population|Response was determined using EULAR criteria based upon DAS28 absolute scores at the assessment visit and the DAS28 reduction from Baseline. Participants with a score <=3.2 and reduction of >1.2 points were assessed as having a 'good' response. Participants with a score >3.2 with reduction of >1.2 points, or a score <=5.1 with reduction of >0.6 to <=1.2 points, were assessed as having a 'moderate' response. Participants with a score >5.1 with reduction of >0.6 to <=1.2 points, or any score with reduction ≤0.6 points, were assessed as nonresponders with response recorded as 'none.' Participants with response is reported. DAS28 is described in outcome measure 19.|Week 12, 24|Safety population. N=participants who were evaluable for this outcome measure. n=number of evaluable participants in each category.||percentage of participants|||Number
688837|NCT01462162|Secondary|Percentage of Participants Achieving a Response According to European League Against Rheumatism (EULAR) Criteria at Week 12 and 24|Response was determined using EULAR criteria based upon DAS28 absolute scores at the assessment visit and the DAS28 reduction from Baseline. Participants with a score <=3.2 and reduction of >1.2 points were assessed as having a 'good' response. Participants with a score >3.2 with reduction of >1.2 points, or a score <=5.1 with reduction of >0.6 to <=1.2 points, were assessed as having a 'moderate' response. Participants with a score >5.1 with reduction of >0.6 to <=1.2 points, or any score with reduction ≤0.6 points, were assessed as nonresponders with response recorded as 'none.' Participants with response is reported. DAS28 is described in outcome measure 19.|Week 12, 24|Effectiveness analysis population. N=participants who were evaluable for this outcome measure. n=number of evaluable participants in each category.||percentage of participants|||Number
688838|NCT01462162|Secondary|Change From Baseline in Disease Activity Scale (DAS28) Score at Week 12, 24 - Safety Population|DAS28-4 ESR was calculated from SJC and TJC using 28 joints count, ESR mm/hr and PtGA of disease activity (participant rated arthritis activity assessment). The DAS28-ESR score (14) was calculated using the following formula: DAS28 = 0.56 x (square root TJC) + 0.28 x (square root SJC) + 0.70 x [Ln(ESR)] + 0.014 x (PtGA).Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) <=3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = remission. PtGA measured using a 100 mm VAS ranging from 0 = very good to 100 = very bad. Analysis include only those participants who had available data at Weeks 12 and 24, respectively.|Baseline, Week 12, 24|Safety population. N=participants who were evaluable for this outcome measure.||score on a scale||Standard Deviation|Mean
688848|NCT01462162|Secondary|Change From Baseline in Number of Swollen Joint Count (SJC) at Week 12, 24 - Safety Population|Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.|Baseline, Week 12, 24|Safety population. N=participants who were evaluable for this outcome measure. n=number of participants evaluable in each category.||swollen joints||Standard Deviation|Mean
688883|NCT01461811|Secondary|Front Surface Deposits (None, Very Slight)|"Front surface deposits on the contact lens, as assessed by the investigator for each eye individually. Front surface deposits were graded on a 5-point scale: 0=none, 1=very slight, 2=slight, 3=moderate, 4=severe. The combined percentage of lenses assessed as none or very slight is reported. Lenses from both eyes contributed to the percentage."|Up to Month 3|All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.||Percentage of lenses|||Number
688839|NCT01462162|Secondary|Change From Baseline in Disease Activity Scale (DAS28) Score at Week 12, 24|DAS28-4 erythrocyte sedimentation rate (ESR) was calculated from SJC and tender joint count (TJC) using 28 joints count, ESR millimeter per hour (mm/hr) and patient global assessment (PtGA) of disease activity (participant rated arthritis activity assessment). The DAS28-ESR score (14) was calculated using the following formula: DAS28 = 0.56 x (square root TJC) + 0.28 x (square root SJC) + 0.70 x [Ln(ESR)] + 0.014 x (PtGA).Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) less than or equal to (<=) 3.2 implied low disease activity and greater than (>)3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) less than (<)2.6 = remission. PtGA measured using a 100 mm VAS ranging from 0 = very good to 100 = very bad. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.|Baseline, Week 12, 24|Effectiveness analysis: All participants who had at least one measurement of effectiveness subsequent to the start of tocilizumab (RoActemra) treatment were included. N=participants who were evaluable for this outcome measure. n=number of evaluable participants in each category.||score on a scale||Standard Deviation|Mean
688840|NCT01462162|Secondary|Change From Baseline in Depression Score as Assessed by the Beck Depression Inventory at Week 12, 24 - Safety Population|Mood assessed by the Beck Depression Inventory. The Beck Depression Inventory is a 21-item self-administered scale that evaluates severity of depression and is validated in Spanish on a 3 point scale (0=none to 3=severe). It measures the characteristic attitudes and symptoms of depression such as mood, pessimism, sense of failure, self-dissatisfaction, guilt, punishment, self-dislike, self-accusation, etc. The total score ranges from 0 to 63. A score higher than 18 indicates moderate to severe symptoms of depression. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.|Baseline, Week 12, 24|Safety population. N=participants who were evaluable for this outcome measure. n=number of participants evaluable in each category.||score on a scale||Standard Deviation|Mean
688841|NCT01462162|Secondary|Change From Baseline in Depression Score as Assessed by the Beck Depression Inventory at Week 12, 24|Mood assessed by the Beck Depression Inventory. The Beck Depression Inventory is a 21-item self-administered scale that evaluates severity of depression and is validated in Spanish on a 3 point scale (0=none to 3=severe). It measures the characteristic attitudes and symptoms of depression such as mood, pessimism, sense of failure, self-dissatisfaction, guilt, punishment, self-dislike, self-accusation, etc. The total score ranges from 0 to 63. A score higher than 18 indicates moderate to severe symptoms of depression. Analysis include only those participants who had available data at Weeks 12 and 24, respectively.|Baseline, Week 12, 24|Effectiveness analysis population. N=participants who were evaluable for this outcome measure.||score on a scale||Standard Deviation|Mean
688842|NCT01462162|Secondary|Change From Baseline in Sleepiness Score as Assessed on Epworth Sleepiness Scale at Week 12, 24 - Safety Population|Degree of sleepiness was assessed by Epworth Sleepiness Scale. The Epworth Sleepiness Scale evaluates how likely a person is to doze off or fall asleep in 8 different sedentary situations, using for each item possible scores of 0 to 3 (0=never, 1=mild, 2=moderate and 3=severe). A final score is obtained between 0-24, where a higher score indicates a higher degree of sleepiness. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.|Baseline, Week 12, 24|Safety population. N=participants who were evaluable for this outcome measure. n=number of participants evaluable in each category.||score on a scale||Standard Deviation|Mean
688843|NCT01462162|Secondary|Change From Baseline in Sleepiness Score as Assessed on Epworth Sleepiness Scale at Week 12, 24|Degree of sleepiness was assessed by Epworth Sleepiness Scale. The Epworth Sleepiness Scale evaluates how likely a person is to doze off or fall asleep in 8 different sedentary situations, using for each item possible scores of 0 to 3 (0=never, 1=mild, 2=moderate and 3=severe). A final score is obtained between 0-24, where a higher score indicates a higher degree of sleepiness. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.|Baseline, Week 12, 24|Effectiveness analysis population. N=participants who were evaluable for this outcome measure. n=number of evaluable participants in each category.||score on a scale||Standard Deviation|Mean
688844|NCT01462162|Secondary|Change From Baseline in Pain Scores as Assessed by Visual Analogue Scale (VAS) at Week 12, 24 - Safety Population|Change from Baseline in 10 cm VAS pain score; 10-point pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. Change = scores at observation minus score at Baseline. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.|Baseline, Week 12, 24|Safety population. N=participants who were evaluable for this outcome measure. n=number of participants evaluable in each category.||centimeter||Standard Deviation|Mean
688845|NCT01462162|Secondary|Change From Baseline in Pain Scores as Assessed by Visual Analogue Scale (VAS) at Week 12, 24|Change from Baseline in 10 centimeter (cm) VAS pain score; 10-point pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. Change = scores at observation minus score at Baseline. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.|Baseline, Week 12, 24|Effectiveness analysis population. N=participants who were evaluable for this outcome measure.||centimeter||Standard Deviation|Mean
688846|NCT01462162|Secondary|Change From Baseline in Duration of Morning Stiffness at Week 12, 24 - Safety Population|Duration of morning stiffness assessed as time taken to achieve maximum improvement from time participant rises. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.|Baseline, Week 12, 24|Safety population. N=participants who were evaluable for this outcome measure. n=number of participants evaluable in each category.||hours||Standard Deviation|Mean
688847|NCT01462162|Secondary|Change From Baseline in Duration of Morning Stiffness at Week 12, 24|Duration of morning stiffness assessed as time taken to achieve maximum improvement from time participant rises. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.|Baseline, Week 12, 24|Effectiveness analysis population. N=participants who were evaluable for this outcome measure.||hours||Standard Deviation|Mean
688904|NCT01461551|Secondary|Intensive Care Unit Staying Days||participants will stay in intensive care unit after surgery, an expected average of 2 days||||||
688849|NCT01462162|Secondary|Change From Baseline in Number of Swollen Joint Count (SJC) at Week 12, 24|Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.|Baseline, Week 12, Week 24|Effectiveness analysis population. N=participants who were evaluable for this outcome measure.||swollen joints||Standard Deviation|Mean
688850|NCT01462162|Secondary|Regression Coefficient Between Change in Hemoglobin Level at Week 12, 24 and Change in the Number of Swollen Joints (SJC 28) at Week 12 and 24 - Safety Population|Regression analysis between the change in hemoglobin level and number of swollen joints was evaluated. Hemoglobin level was measure in g/L. The regression coefficient (R) and coefficient of determination (R^2) were calculated. Difference (1-R^2) indicates the variation in the changes in hemoglobin not explained by the independent variables, that is, independent contribution of these changes in hemoglobin to the assessment of RA. Only variables with available data were reported.|Week 12, 24|Safety analysis population. N=participants who were evaluable for this outcome measure. n=number of participants evaluable in each category.||unstandardized regression coefficient|||Number
688851|NCT01462162|Secondary|Regression Coefficient Between Change in Hemoglobin Level at Week 12, 24 and Change in Disease Activity at Week 12 and 24 - Safety Population|Regression analysis between change in hemoglobin level and change in following variable were assessed: Epworth sleepiness scale (total score range: 0-24, higher score=higher degree of sleepiness), back depression inventory (total score range: 0-63, score higher than 18 indicates moderate to severe symptoms of depression), swollen joint count, morning stiffness (time taken to achieve maximum improvement), degree of pain (assessed on horizontal visual scale, 0=no pain; 10=maximum pain). Hemoglobin level was measure in g/L. The regression coefficient (R) and coefficient of determination (R^2) were calculated. Difference (1-R^2) indicates the variation in the changes in hemoglobin not explained by the independent variables, that is, independent contribution of these changes in hemoglobin to the assessment of RA. Only variables with available data were reported.|Week 12, 24|Safety analysis population. Here, N=number of participants analyzed for this measure.||unstandardized regression coefficient|||Number
688852|NCT01462162|Secondary|Regression Coefficient Between Change in Hemoglobin Level at Week 12, 24 and Change in Disease Activity at Week 12 and 24|Regression analysis between change in hemoglobin level and change in following variable were assessed: Epworth sleepiness scale (total score range: 0-24, higher score=higher degree of sleepiness), back depression inventory (total score range: 0-63, score higher than 18 indicates moderate to severe symptoms of depression), swollen joint count, morning stiffness (time taken to achieve maximum improvement), degree of pain (assessed on horizontal visual scale, 0=no pain; 10=maximum pain). Hemoglobin level was measure in g/L. The regression coefficient (R) and coefficient of determination (R^2) were calculated. Difference (1-R^2) indicates the variation in the changes in hemoglobin not explained by the independent variables, that is, independent contribution of these changes in hemoglobin to the assessment of RA. Only variables with available data were reported.|Week 12, 24|Effectiveness analysis population. N=number of participants analyzed for this measure.||unstandardized regression coefficient|||Number
688853|NCT01462162|Secondary|Regression Coefficient Between Change in Fatigue Score as Measured by the FACIT-F at Week 12 and 24 With Change in Disease Activity Parameters at Week 12 and 24|Regression analysis between change in FACIT-F scale and change in following variable were assessed: DAS28-ESR (total score range: 0-9.4, higher score=more disease activity), Epworth sleepiness scale (total score range: 0-24, higher score=higher degree of sleepiness), back depression inventory (total score range: 0-63, score higher than 18 indicates moderate to severe symptoms of depression), serum hemoglobin, swollen joint count, morning stiffness (time taken to achieve maximum improvement), degree of pain (assessed on horizontal visual scale, 0=no pain; 10=maximum pain). The total score of the FACIT-F questionnaire ranges from 0=worse score to 52=better score. Regression coefficient (R) and coefficient of determination (R^2) were calculated. Difference (1-R^2)=the variation in the changes in fatigue not explained by independent variables, that is, independent contribution of these changes in fatigue to the assessment of RA. Only variables with available data were reported.|Week 12, 24|Effectiveness analysis population. Here, N=number of participants analyzed for this measure.||unstandardized regression coefficient|||Number
688854|NCT01462162|Secondary|Change From Baseline to Week 12 and 24 in Serum Hemoglobin|The hemoglobin level was measured in grams per liter (g/L). Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.|Baseline, Week 12, 24|Effectiveness analysis population. N=participants who were evaluable for this outcome measure. n=number of evaluable participants for each category.||g/L||Standard Deviation|Mean
688855|NCT01462162|Secondary|Change From Baseline to Week 12 and 24 in Fatigue Score as Assessed by FACIT-F|FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant’s response to the questions (with the exception of 2 negatively stated), greater was the participant’s fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant’s response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score).|Baseline, Week 12, Week 24|Effectiveness analysis population.||units on a scale||Standard Deviation|Mean
688856|NCT01462162|Primary|Regression Coefficient Between Change in Fatigue Score as Measured by the FACIT-F at Week 24 and Change in Main Variables at Week 24|Regression analysis between change in FACIT-F scale and change in following variable were assessed: DAS28-ESR (total score range: 0-9.4, higher score=more disease activity), Epworth sleepiness scale (total score range: 0-24, higher score=higher degree of sleepiness), back depression inventory (total score range: 0-63, score higher than 18 indicates moderate to severe symptoms of depression). The total score of the FACIT-F questionnaire ranges from 0=worse score to 52=better score. Regression coefficient (R) and coefficient of determination (R^2) were calculated. Difference (1-R^2)=the variation in the changes in fatigue not explained by independent variables, that is, independent contribution of these changes in fatigue to the assessment of RA. Only variables with available data were reported.|Week 24|Effectiveness analysis population. Here, N=number of participants evaluable for this measure.||unstandardized regression coefficient|||Number
690142|NCT01451398|Secondary|Time to Rescue|Time from Week 0 (baseline) to initiation of rescue therapy (up to a maximum of 24 weeks/end of treatment) for subjects not responding to treatment|Baseline to Week 24|Full analysis set||Days||Full Range|Median
688857|NCT01462162|Primary|Regression Coefficient Between Change in Fatigue Score as Measured by the Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F) at Week 12 and Change in Main Variables at Week 12|Regression analysis between change in FACIT-F scale and change in following variable were assessed: DAS28-ESR (total score range: 0-9.4, higher score=more disease activity), Epworth sleepiness scale (total score range: 0-24, higher score=higher degree of sleepiness), back depression inventory (total score range: 0-63, score higher than 18 indicates moderate to severe symptoms of depression). The total score of the FACIT-F questionnaire ranges from 0=worse score to 52=better score. Regression coefficient (R) and coefficient of determination (R^2) were calculated. Difference (1-R^2)=the variation in the changes in fatigue not explained by independent variables, that is, independent contribution of these changes in fatigue to the assessment of RA. Only variables with available data were reported.|Week 12|Effectiveness analysis population included all participants who had all measurements of effectiveness and had complete information of the FACIT questionnaire throughout the study. Here, Number of participants analyzed (N) = number of participants evaluable for this measure.||unstandardized regression coefficient|||Number
688858|NCT01462084|Secondary|Patient Comfort|Subjects completed patient-satisfaction questionnaires after each polysomnography (PSG) study. Satisfaction with PAP: 0=Very Dissatisfied, 100=Very Satisfied|Up to 1 month|||units on a scale||Standard Deviation|Mean
688859|NCT01462084|Primary|Apnea Hypopnea Index (AHI)|Subjects completed 2 overnight sleep studies (polysomnography (PSG)). The Apnea Hypopnea Index (AHI) metric is collected from the PSG study. Patients were equally distributed according to the therapy used first (ASV then Bi-Level or Bi-Level then ASV).|Up to 1 month|||events/hour||Standard Deviation|Mean
688860|NCT01462045|Secondary|Cortisol|Change from baseline in serum cortisol levels at 8 weeks. Serum cortisol samples were collected at 8:00 Ante Meridian (AM). The changes are calculated from two time points as the values at 8 weeks minus the values at baseline.|baseline and 8 weeks|||μg/dl||Standard Deviation|Mean
688861|NCT01462045|Primary|Change From Baseline in PTSD Checklist - Civilian Version (PCL-C) Score|The PCL-C is a 17-item self-report instrument that measures the symptoms of PTSD. A total score, ranging from 17 to 85, is found by summing the scores of the 17 items. Higher values are considered to be a worse outcome. The inclusion criteria in the PTSD symptomatic group is a PCL-C total score of at least 28 with a score of 3 or higher on 1 or more items.To detect a reduction in PTSD symptom severity with a 2-sided 5% significance level and a power of 80%, the mean difference of PCL-C scores of 5.16 or greater requires a sample size of 20 participants for Exercise and Control groups, given an anticipated dropout rate of 10%. Data analyses are conducted using an a priori intention-to-treat approach. The analysis for the between-group differences of the intervention is conducted using t-tests comparing Exercise and Control groups at post-intervention. The analysis for the within-group difference is conducted using repeated measures ANOVA for both groups at baseline and week 8.|Baseline and 8 weeks|For Base Group, the values entered represent the mean value of the baseline PCL-C scores. The mean difference score for the Base Group is not available because the Base Group was assessed only at baseline.||scores on a scale||Standard Deviation|Mean
688862|NCT01461993|Primary|Percentage of Participants With at Least One Adverse Event (AE)||Vaccination 1 up to 1 month after Vaccination 3|||percentage of participants|||Number
688863|NCT01461993|Secondary|Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titer (GMT)||Before Vaccination 1, 1 month after Vaccination 2, 3|||titer||95% Confidence Interval|Geometric Mean
688864|NCT01461993|Secondary|Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level||Before Vaccination 1, 1 month after Vaccination 2, 3|||percentage of participants|||Number
688865|NCT01461993|Secondary|Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)||Before vaccination 1, 1 month after vaccination (Vac) 2, 3|||percentage of participants|||Number
688866|NCT01461993|Secondary|Percentage of Baseline Seropositive Participants: Group 1 and 3 Participants||Before vaccination 1|||percentage of participants|||Number
688867|NCT01461993|Secondary|Percentage of Participants Achieving Seroconversion for Human Papillomavirus (HPV)||1 month after Vaccination 3|||percentage of participants|||Number
688868|NCT01461993|Primary|Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24]||1 month after Vaccination 3|||titer||95% Confidence Interval|Geometric Mean
688869|NCT01461993|Primary|Geometric Mean Titer (GMT) of Human Papillomavirus (HPV) Antigens||1 month after Vaccination 3|||titer||95% Confidence Interval|Geometric Mean
688870|NCT01461980|Other Pre-specified|Percentage of Participants With at Least One Adverse Event (AE)|An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship.|Vaccination phase (baseline up to 1 month after Vaccination 3); Follow-up phase (from 1 month up to 6 months after Vaccination 3)|Safety population included all participants who received at least 1 dose of the investigational product and had safety information available. 'N' signifies participants evaluable for this measure during specified time period.||percentage of participants|||Number
688871|NCT01461980|Other Pre-specified|Percentage of Participants Achieving at Least 4-Fold Increase in Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level||1 Month after Vaccination (Vac) 2, 3|Post vaccination 3 evaluable immunogenicity population. Here, ‘number of participants analyzed’ signifies evaluable immunogenicity population and 'N' signifies participants with valid and determinate hSBA titers for the given strain at both the specified time point and baseline.||percentage of participants||95% Confidence Interval|Number
688872|NCT01461980|Other Pre-specified|Immunogloblulin G (IgG) Measured by GMC|IgG GMCs of 4 MCV4 antigens (serogroup A, serogroup C, serogroup Y and serogroup W-135) of participants were computed along with corresponding 2-sided 95% CIs. CIs were back transformations of confidence levels based on Student t distribution for mean logarithm of titers.|Before Vaccination 1, 1 Month after Vaccination 1|Post vaccination 1 evaluable immunogenicity population.||microgram per milliliter (mcg/mL)||95% Confidence Interval|Geometric Mean
688905|NCT01461551|Primary|Lymphocyte Count|Blood samples were obtained 24 h after the surgery for routine blood examination. This analysis was performed in the hospital laboratory using routine laboratory procedures.|1 day after surgery|||cells/nanoliter||Standard Deviation|Mean
690143|NCT01451398|Secondary|Proportion of Subjects Requiring Rescue Therapy||Baseline to Week 24|Full analysis set||percentage of participants|||Number
688873|NCT01461980|Secondary|Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level|Antibody hSBA of primary strain PMB80 [A22] and PMB2948 [B24] with hSBA titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 were computed along with corresponding 2-sided 95% CIs.|Before Vaccination 1, 1 Month after Vaccination (Vac) 2, 3|Post vaccination 3 evaluable immunogenicity population. Here, ‘number of participants analyzed’ signifies evaluable immunogenicity population and 'N' signifies participants with valid and determinate assay results for given strain for each group, respectively.||percentage of participants||95% Confidence Interval|Number
688874|NCT01461980|Secondary|Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Lower Limit of Quantitation (LLOQ)|Percentage of participants achieving hSBA titer >= LLOQ were computed along with corresponding 2-sided 95% CIs. LLOQ was 1:16 for PMB80 [A22] and 1:8 for PMB2948 [B24].|Before Vaccination 1, 1 Month after Vaccination (Vac) 2, 3|Post vaccination 3 evaluable immunogenicity population. Here, ‘number of participants analyzed’ signifies evaluable immunogenicity population and 'N' signifies participants with valid and determinate assay results for given strain for each group, respectively.||percentage of participants||95% Confidence Interval|Number
688875|NCT01461980|Secondary|Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24] Before Vaccination 1 and 1 Month After Vaccination 2|Antibody hSBA of primary strain PMB80 [A22] and PMB2948 [B24] were computed along with corresponding 2-sided 95% CIs. hSBA titers from the 2 primary strains were logarithmically transformed for analysis.|Before Vaccination 1, 1 Month after Vaccination (Vac) 2|Post vaccination 3 evaluable immunogenicity population. Here, ‘number of participants analyzed’ signifies evaluable immunogenicity population and 'N' signifies participants with valid and determinate assay results for given strain for each group, respectively.||titer||95% Confidence Interval|Geometric Mean
688876|NCT01461980|Secondary|Percentage of Participants Achieving Predefined Antibody Level for Diphtheria and Tetanus Antigens|Participants with antibody concentration level of greater than or equal to 1.0 IU/mL for diphtheria and tetanus antigens were computed along with corresponding 2-sided 95% CIs.|1 Month after Vaccination 1|Post vaccination 1 evaluable immunogenicity population. Here, ‘number of participants analyzed’ signifies participants with valid, determinate assay results for given antigen.||percentage of participants||95% Confidence Interval|Number
688877|NCT01461980|Secondary|Percentage of Participants With Seroresponse for Tetanus, Diphtheria and Acellular Pertussis (Tdap) and Meningococcal Conjugate Vaccine (MCV4) Antigens|Seroconversion rate for Tdap antigens was defined as greater than or equal to (>=) 4-, 2-fold rise in antibody concentration, if prevaccination antibody concentration was less than or equal to (<=), greater than (>) cutoff value, respectively. For MCV4 antigens >=4-fold rise on serum bactericidal assay using rabbit complement (rSBA) titers if baseline value >= lower limit of quantitation (LLOQ), postdose rSBA titers >=2×LLOQ if baseline value was less than (<) LLOQ. Cutoff value =0.1 IU/mL for diphtheria and tetanus, 0.9,2.9,3.0,10.6 EU/mL for pertussis toxoid, filamentous hemagglutinin, pertactin, fimbriae agglutinogens types 2 + 3, respectively.|1 Month after Vaccination 1|Post vaccination 1 evaluable immunogenicity population. Here, ‘number of participants analyzed’ signifies participants with valid, determinate assay results for given antigen at specified time point and baseline. 'N' signifies number of participants with seroresponse.||percentage of participants||95% Confidence Interval|Number
688878|NCT01461980|Primary|Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24] 1 Month After Vaccination 3|Antibody hSBA GMTs of primary strain PMB80 [A22] and PMB2948 [B24] were computed along with corresponding 2-sided 95% CIs. hSBA titers from the 2 primary strains were logarithmically transformed for analysis. Here, ‘number of participants analyzed’ signifies evaluable immunogenicity population and 'N' signifies participants with valid and determinate assay results for given strain for each group, respectively.|1 Month after Vaccination 3|Post vaccination 3 evaluable immunogenicity population: eligible participants randomized to Group 1 or 3, received scheduled investigational product, had pre and post vaccination blood drawn at pre-specified time points, had valid, determinate assay results for proposed analysis, received no prohibited vaccines, no other major protocol violations.||titer||95% Confidence Interval|Geometric Mean
688879|NCT01461980|Primary|Geometric Mean Titer (GMT) for Meningococcal Conjugate Vaccine (MCV4) Antigens|Antibody GMTs of 4 MCV4 antigens (serogroup A, serogroup C, serogroup Y and serogroup W-135) were computed along with corresponding 2-sided 95% CIs.|1 Month after Vaccination 1|Post vaccination 1 evaluable immunogenicity population. Here, ‘N’ signifies participants with valid and determinate assay results for given strain for each group, respectively.||titer||95% Confidence Interval|Geometric Mean
688880|NCT01461980|Primary|Geometric Mean Concentrations (GMC) for Acellular Pertussis Antigens|Antibody GMCs of 4 acellular pertussis antigens (pertussis toxoid, pertussis filamentous hemagglutinin, pertussis pertactin and pertussis fimbrial agglutinogens types 2+3) were computed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EU/mL) along with corresponding 2-sided 95% CIs.|1 Month after Vaccination 1|Post vaccination 1 evaluable immunogenicity population. Here, ‘number of participants analyzed’ signifies participants with valid and determinate assay results for given antigen.||EU/mL||95% Confidence Interval|Geometric Mean
688881|NCT01461980|Primary|Geometric Mean Concentrations (GMC) for Diphtheria and Tetanus Antigens|Antibody GMCs of 2 antigens of diphtheria and tetanus toxoid were computed in International Units per milliliter (IU/mL) along with corresponding 2-sided 95 percent (%) confidence intervals (CIs). Here, ‘number of participants analyzed’ signifies participants with valid and determinate assay results for given antigen.|1 Month after Vaccination 1|Post vaccination 1 evaluable immunogenicity population: eligible participants randomized to Group 1 or 2, received scheduled investigational product, had pre and post vaccination blood drawn at pre-specified time points, had valid, determinate assay results for proposed analysis, received no prohibited vaccines, no other major protocol violations.||IU/mL||95% Confidence Interval|Geometric Mean
688882|NCT01461811|Secondary|Back Surface Debris/Deposits (None, Very Slight)|"Back surface debris/deposits on the contact lens, as assessed by the investigator for each eye individually. Back surface debris/deposits were graded on a 5-point scale: 0=none, 1=very slight, 2=slight, 3=moderate, 4=severe. The combined percentage of lenses assessed as none or very slight is reported. Lenses from both eyes contributed to the percentage."|Up to Month 3|All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.||Percentage of lenses|||Number
688884|NCT01461811|Secondary|Front Surface Wettability (None, Very Slight)|"Front surface wettability (i.e., assessment of the disruption of the front surface wettability of the contact lens), as assessed by the investigator for each eye individually. Front surface wettability was graded on a 5-point scale: 0=none, 1=very slight, 2=slight, 3=moderate, 4=severe. The combined percentage of lenses assessed as none or very slight is reported. Lenses from both eyes contributed to the percentage."|Up to Month 3|All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.||Percentage of lenses|||Number
688885|NCT01461811|Secondary|Lens Fit (Optimal, Acceptably Loose, Acceptably Tight)|"Lens fit, as assessed by the investigator for each eye individually. Lens fit was graded on a 5-point scale: 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight. The combined percentage of lenses assessed as optimal, acceptably loose, or acceptably tight is reported. Lenses from both eyes contributed to the percentage."|Up to Month 3|All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.||Percentage of lenses|||Number
688886|NCT01461811|Secondary|Lens Centration (Centered, Slight Decentration)|"Lens centration, as assessed by the investigator for each eye individually. Lens centration was graded on a 5-point scale: 0=centered, 1=slight decentration, 2=mild decentration, 3=moderate decentration, 4=severe decentration. The combined percentage of lenses assessed as centered or slight decentration is reported. Lenses from both eyes contributed to the percentage."|Up to Month 3|All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.||Percentage of lenses|||Number
688887|NCT01461811|Secondary|Subjective Rating of Overall Handling|Overall handling, as rated by the participant on a 10-point scale, with 1 being difficult and 10 being easy. The participant rated both eyes together by providing one single rating.|Up to Month 3|All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.||Units on a scale||Standard Deviation|Mean
688888|NCT01461811|Secondary|Subjective Rating of Overall Vision|Overall vision, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.|Up to Month 3|All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.||Units on a scale||Standard Deviation|Mean
688889|NCT01461811|Secondary|Subjective Rating of End of Day Dryness|End of day dryness, as rated by the participant on a 10-point scale, with 1 being dry and 10 being not dry. The participant rated both eyes together by providing one single rating.|Up to Month 3|All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.||Units on a scale||Standard Deviation|Mean
688890|NCT01461811|Secondary|Subjective Rating of Overall Comfort|Overall comfort, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.|Up to Month 3|All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.||Units on a scale||Standard Deviation|Mean
688891|NCT01461811|Secondary|Subjective Rating of End of Day Comfort|End of day comfort, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.|Up to Month 3|All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.||Units on a scale||Standard Deviation|Mean
688892|NCT01461811|Secondary|Subjective Rating of Insertion Comfort|Insertion comfort (30 seconds to 1 minute), as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.|Up to Month 3|All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.||Units on a scale||Standard Deviation|Mean
688893|NCT01461811|Primary|Contact Lens-Corrected Distance Monocular Snellen Visual Acuity (VA) (20/30 or Better)|Visual acuity, as assessed for each eye individually. Participant read a distance Snellen chart while wearing study lenses. The percentage of eyes with VA recorded as 20/30 or better is reported. Both eyes contributed to the percentage.|Up to Month 3|All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.||Percentage of eyes|||Number
688894|NCT01461733|Primary|Conversion From Atrial Fibrillation to Sinus Rhythm|Conversion rates measured during ICU stay only. Average duration of ICU stay is 7 days.|From randomization to conversion or ICU discharge up to 100 months.|||participants|||Number
688895|NCT01461707|Secondary|7-Day Physical Activity Recall|Change in mean energy expenditure|12 weeks|||kcal/day||Standard Deviation|Mean
688896|NCT01461707|Primary|Physical Activity Monitor Measured Steps|Change in mean steps per day|12 weeks|||step||Standard Deviation|Mean
688897|NCT01461655|Secondary|Investigator Global Assessment (IGA) of Disease Severity|"The investigator made an assessment of the disease severity (Plaque thickening, Scaling and Erythema) using a 6-point scale (Clear, Almost clear, Mild, Moderate, Severe, and Very severe).
The outcome was the proportion of success (improvement of two grades of the IGA) from baseline to the end of treatment. “Success” is defined as improvement of two grades from the baseline assessment."|Baseline to End of treatment (4 weeks)|||participants|||Number
688898|NCT01461655|Secondary|Percentage Change in Total Lesions Count|Percentage change in total lesions count from baseline to day 22|Baseline to Day 22|||percentage of change||Standard Deviation|Mean
688899|NCT01461655|Secondary|Percentage Change in Total Lesions Count|Percentage change in total lesions count from baseline to day 15|Baseline to Day 15|||percentage of change||Standard Deviation|Mean
688900|NCT01461655|Secondary|Percentage Change in Total Lesions Count|Percentage change in total leasions count from baseline to day 8|Baseline to Day 8|||percentage of change||Standard Deviation|Mean
688901|NCT01461655|Secondary|Total Lesions Count|Percentage change in total lesions count from baseline to the end of treatment|Baseline to End of treatment (4 weeks)|||percentage of change||Standard Deviation|Mean
688902|NCT01461655|Secondary|Non-inflammatory Lesions Count|Percentage change in non-inflammatory lesions count from baseline to the end of treatment|Baseline to End of treatment (4 weeks)|||percentage of change||Standard Deviation|Mean
688903|NCT01461655|Primary|Percentage Change in Inflammatory Lesions From Baseline to End of Treatment|Percentage change in inflammatory lesions count from baseline to the end of treatment|Baseline to End of treatment (4 weeks)|||percentage of change||Standard Deviation|Median
688906|NCT01461538|Secondary|Incidence of Anti-therapeutic Antibodies (ATA)|Counts of participants with post-baseline anti-brentuximab vedotin antibodies. Persistently positive is defined as confirmed ATA in more than 2 post-baseline samples and transiently positive is defined as confirmed ATA in 1 or 2 post-baseline samples.|Up to approximately 3 years|Immunogenicity-evaluable set||participants|||Number
688907|NCT01461538|Secondary|Brentuximab Vedotin Monomethyl Auristatin E (MMAE) Trough Concentration (Ctrough)||Up to approximately 3 years|All treated patients with available MMAE Ctrough results||ng/mL||Geometric Coefficient of Variation|Geometric Mean
688908|NCT01461538|Secondary|Maximum Concentration (Cmax) of Brentuximab Vedotin Monomethyl Auristatin E (MMAE)||Up to approximately 3 years|All treated patients with available Cmax of MMAE results||ng/mL||Geometric Coefficient of Variation|Geometric Mean
688909|NCT01461538|Secondary|Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Trough Concentration (Ctrough)||Up to approximately 3 years|All treated patients with available ADC Ctrough results||ug/mL||Geometric Coefficient of Variation|Geometric Mean
688910|NCT01461538|Secondary|Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Concentration at End of Infusion (Ceoi)||Up to approximately 3 years|All treated patients with available ADC Ceoi results||ug/mL||Geometric Coefficient of Variation|Geometric Mean
688911|NCT01461538|Secondary|Laboratory Abnormalities >/= Grade 3|Counts of study participants with post-baseline laboratory abnormalities of Grade 3 or greater per NCI CTCAE version 4.03. Participants with multiple occurrences of a laboratory abnormality within a category are counted once in that category|Up to approximately 3 years|All treated patients||participants|||Number
688912|NCT01461538|Secondary|Adverse Events by Severity, Seriousness, and Relationship to Treatment|Counts of participants who had treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose on Study SGN35-013). Serious adverse events are reported from the time of informed consent. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.03) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life-threatening/disabling, 5=fatal). Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an adverse event within a category are counted once within the category.|Up to approximately 3 years|All treated patients||participants|||Number
688913|NCT01461538|Secondary|Progression-Free Survival by Kaplan-Meier Analysis|Progression-free survival, defined as time from start of study treatment to disease progression per investigator or death due to any cause|Up to approximately 2 years|All treated patients, excluding 3 patients without available response results||months||95% Confidence Interval|Median
688914|NCT01461538|Secondary|Duration of Complete Response by Kaplan-Meier Analysis|Duration of CR, defined as time of initial response until disease progression or death. Response criteria for solid tumors (by radiographic tumor imaging) per Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 (Eisenhauer 2009); response criteria for leukemia (by peripheral blood and bone marrow aspirate or biopsy) per International Working Group (Cheson 2003).|Up to approximately 2 years|Participants with CR||months||Full Range|Median
688915|NCT01461538|Secondary|Duration of Objective Response by Kaplan-Meier Analysis|Duration of objective response (CR [+CRi; leukemia] + PR), defined as time of initial response until disease progression or death. Response criteria for solid tumors (by radiographic tumor imaging) per Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 (Eisenhauer 2009); response criteria for leukemia (by peripheral blood and bone marrow aspirate or biopsy) per International Working Group (Cheson 2003).|Up to approximately 2 years|Participants with objective response (CR [+CRi; leukemia] + PR)||months||Full Range|Median
688916|NCT01461538|Secondary|Complete Remission (CR) Rate by Investigator|Percentage of participants who achieved a best response of CR per the applicable response criteria. Response criteria for solid tumors (by radiographic tumor imaging) per Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 (Eisenhauer 2009); response criteria for leukemia (by peripheral blood and bone marrow aspirate or biopsy) per International Working Group (Cheson 2003).|Up to approximately 3 years|Efficacy-evaluable population||percentage of participants||95% Confidence Interval|Number
688917|NCT01461538|Primary|Objective Response Rate (ORR) by Investigator|Percentage of participants who achieved a best response of complete response/remission (CR), CR without hematologic recovery (CRi; leukemia only), or partial remission (PR) per the applicable response criteria. Response criteria for solid tumors (by radiographic tumor imaging) per Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 (Eisenhauer 2009); response criteria for leukemia (by peripheral blood and bone marrow aspirate or biopsy) per International Working Group (Cheson 2003).|Up to approximately 3 years|Efficacy-evaluable population||percentage of participants||95% Confidence Interval|Number
688918|NCT01461473|Secondary|Mean Relative Flow-Mediated Vasodilatation of the Brachial Artery by Vascular Ultrasound|Mean relative flow-mediated vasodilatation (FMD) of the brachial artery (i.e., the mean change in brachial artery diameter from baseline to the value that is obtained after the cuff deflation, divided by the baseline value and multiplied by 100) as measured by vascular ultrasound (VU) at the 6-month visit|6 months|||percent change||Standard Deviation|Mean
688919|NCT01461473|Secondary|Mean Absolute Flow-Mediated Vasodilatation of the Brachial Artery by Vascular Ultrasound|Mean absolute flow-mediated vasodilatation (FMD) of the brachial artery (i.e., the mean change in brachial artery diameter [in millimeters] from baseline to the value that is obtained after the cuff deflation) as measured by vascular ultrasound (VU) at the 6-month visit|6 months|||mm||Standard Deviation|Mean
688920|NCT01461473|Secondary|Ratio of NMAP to Daytime Mean Arterial Pressure at 6 Months|Ratio of NMAP to daytime mean arterial pressure, expressed as a percentage at the 6 month visit for PAP and OA arms. The ratio is calculated by dividing the NMAP by the daytime mean arterial pressure; the result is then multiplied by 100 to obtain a percentage.|6 months|Two participants in the PAP arm and 1 participant in the OA arm did not have sufficient daytime MAP data to calculate the ratio of NMAP to daytime MAP at 6 months||percentage of NMAP to daytime MAP||Standard Deviation|Mean
688921|NCT01461473|Secondary|Ratio of Nocturnal Mean Arterial Pressure (NMAP) to Daytime Mean Arterial Pressure at 2 Months|Ratio of NMAP to mean daytime arterial pressure, expressed as a percentage at the 2 month visit for PAP and OA arms. The ratio is calculated by dividing the NMAP by the daytime mean arterial pressure; the result is then multiplied by 100 to obtain a percentage.|2 months|31 participants in the Positive Airway Pressure arm and 29 participants in the Oral Appliance arm failed to return for 24-hour ambulatory blood pressure monitoring at the two-months time point, but did return at the six-month time point for blood pressure monitoring at the six-month time point and to complete the study.||percentage of NMAP to daytime MAP||Standard Deviation|Mean
688923|NCT01461473|Primary|Nocturnal Mean Arterial Blood Pressure (NMAP) at 2 Months|Mean arterial blood pressure during the sleep period as recorded by 24-hour ambulatory blood pressure monitoring after approximately 2 months of treatment|2 months|31 participants in the Positive Airway Pressure arm and 29 participants in the Oral Appliance arm failed to return for 24-hour ambulatory blood pressure monitoring at the two-months time point, but did return at the six-month time point for blood pressure monitoring at the six-month time point and to complete the study.||mmHg||Standard Deviation|Mean
688924|NCT01461369|Secondary|Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale.|"The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing No Pain and 100 mm representing Worst Pain Imaginable.
The VAS pain intensity difference is calculated as the average of the VAS pain intensity scores at Weeks 2, 6, and 12 minus the VAS pain intensity at baseline."|Baseline to Week 12/Early Termination|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the times specified.||mm||Standard Error|Least Squares Mean
688925|NCT01461369|Secondary|Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Osteoarthritis Pain, Stiffness, and Function Measured Using the Total (Composite) Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score.|"Pain, stiffness, and function in subjects with osteoarthritis were measured using the Western Ontario and McMaster Universities (WOMAC) Index, which is a 24-item questionnaire. The total (composite) WOMAC score is calculated as the average of the mean visual analogue scale (VAS) scores from the questions in the pain, stiffness, and function subscales. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their response to each of the questions, with 0 mm representing No Pain, Stiffness, or Difficulty and 100 mm representing Extreme Pain, Stiffness, and Difficulty.
The total (composite) WOMAC score difference was calculated as the total (composite) WOMAC score assessed at Weeks 2, 6, and 12 minus the total (composite) WOMAC score assessed at baseline."|Baseline to Week 12/Early Termination|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the times specified.||mm||Standard Error|Least Squares Mean
688926|NCT01461369|Secondary|Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.|"The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing No Pain and 100 mm representing Extreme Pain.
The WOMAC pain subscale score difference was calculated as the WOMAC pain subscale score assessed at Weeks 2, 6, and 12 minus the average of the WOMAC pain subscale score assessed at baseline."|Baseline to Week 12/Early Termination|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.||mm||Standard Error|Least Squares Mean
688927|NCT01461369|Secondary|Change From Baseline to Week 6 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.|"The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing No Pain and 100 mm representing Extreme Pain.
The WOMAC pain subscale score difference was calculated as the WOMAC pain subscale score assessed at Week 6 minus the WOMAC pain subscale score assessed at baseline."|Baseline to Week 6|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.||mm||Standard Error|Least Squares Mean
688928|NCT01461369|Secondary|Change From Baseline to Week 2 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.|"The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing No Pain and 100 mm representing Extreme Pain.
The WOMAC pain subscale score difference was calculated as the WOMAC pain subscale score assessed at Week 2 minus the WOMAC pain subscale score assessed at baseline."|Baseline to Week 2|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.||mm||Standard Error|Least Squares Mean
688929|NCT01461369|Primary|Change From Baseline to Week 12 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.|"The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing No Pain and 100 mm representing Extreme Pain.
The WOMAC pain subscale score difference is calculated as the WOMAC pain subscale score assessed at Week 12 minus the WOMAC pain subscale score assessed at baseline."|Baseline to Week 12/Early Termination|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.||mm||Standard Error|Least Squares Mean
688966|NCT01461044|Secondary|Percentage of Participants With Death|Overall survival (OS) was defined as the time between the first administration of bevacizumab and death from any cause and participants still alive at the end of the study were censored at the last consultation or last contact date.|From the first administration of bevacizumab to death from any cause (up to a maximum of 60.8 months including retrospective and prospective treatment)|Efficacy population.||percentage of participants|||Number
717387|NCT00267644|Secondary|Minimum IVC Diameter|Minimum Inferior Vena Cava Diameter in mm|10 minutes|||mm||Full Range|Median
688930|NCT01461096|Secondary|Time to First New Persistent Oral HPV Infection of Vaccine Types Detected From Oral Rinse|"The outcome for this evaluation was time to the first new persistent infection of any of oral HPV 6, 11, 16, or 18. Persistent infection was defined as an infection confirmed by positive oral HPV PCR results at 2 consecutive visits at least 16 weeks apart without an intervening negative result. A participant who had a positive measurement on his/her last measurement with no consecutive confirmatory measurement was considered as having a persistent infection. Participants with pre-existing HPV infection at baseline were evaluable for the primary endpoint if they were PCR negative for at least one of the four vaccine HPV types at baseline.
NOTE: Use 5th and 10th percentiles in years from baseline to the first new persistent infection as the summary measure."|From baseline to participant's last study visit, for up to 4 years|mITT population wherein all participants who received at least one dose of vaccine and all first new persistent infections that began after the first vaccination were included.||Years||95.1% Confidence Interval|Number
688931|NCT01461096|Secondary|Number of Participants With Grade 3 or 4 Adverse Events (AEs) That Were Possibly, Probably, or Definitely Related to the Vaccine, as Determined by the Local Investigator|To grade diagnoses, signs and symptoms, and laboratory results, sites must refer to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, august 2009).|From baseline to participant's last study visit, for up to 4 years|mITT population including all participants who received at least one dose of vaccine.||Participants|||Count of Participants
688932|NCT01461096|Secondary|Number of Participants With Anal Cytological Abnormality Occurrences|Anal cytologic abnormalities include: atypical squamous cells undetermined significance (ASCUS), atypical squamous cells favor high-grade SIL/squamous cell carcinoma (ASC-H), low-grade squamous intraepithelial lesion/mild dysplasia/HPV (LSIL), or high-grade SIL/moderate dysplasia to severe dysplasia/carcinoma in situ/features of invasion (HSIL).|At baseline, Week 52, Week 104 and Week 156|mITT population including all participants who received at least one dose of vaccine.||Participants|||Count of Participants
688933|NCT01461096|Secondary|Number of Participants With Biopsy-proven High-grade Anal Intraepithelial Neoplasia (HGAIN) Occurrences and Reoccurrences After Week 52|HGAIN was defined as AIN2 (moderate dysplasia, with no mention of AIN grade III), AIN3 (severe dysplasia, carcinoma in-situ, or AIN grade II/III), high grade AIN not specified, or adenocarcinoma in situ found in the intra-anal or perianal region.|From Week 52 to participant's last study visit, for up to 4 years|mITT population including all participants who received at least one dose of vaccine.||Participants|||Count of Participants
688934|NCT01461096|Primary|Time to the First New Persistent Infection of HPV 6, 11, 16, or 18|"The outcome for this evaluation was time to the first new persistent infection of any of HPV 6, 11, 16, or 18. Persistent infection was defined as an infection confirmed by positive anal HPV PCR results at 2 consecutive visits at least 16 weeks apart without an intervening negative result. A participant who had a positive measurement on his/her last measurement with no consecutive confirmatory measurement was considered as having a persistent infection. Participants with pre-existing HPV infection at baseline were evaluable for the primary outcome if they were PCR negative for at least one of the four vaccine HPV types at baseline.
NOTE: Use 5th and 10th percentiles in years from baseline to the first new persistent infection as the summary measure."|From baseline to participant's last study visit, for up to 4 years|The efficacy analysis for persistent anal HPV employed a modified intent-to-treat (mITT) approach wherein all participants who received at least one dose of vaccine and all first new persistent infections that began after the first vaccination were included.||Years||95.1% Confidence Interval|Number
688935|NCT01461057|Primary|Number of Participants With Adverse Events (AEs)|An adverse event (AE) was defined as any untoward medical occurrence in a participant administered the investigational product which does not necessarily have a causal relationship with this treatment.|Randomization of first participant to clinical cutoff date (01 March 2015) (approximately 41 months)|Safety population included all participants who received at least one dose of study treatment.||participants|||Number
688936|NCT01461057|Primary|Percentage of Participants With Day 43 Serum Pertuzumab Trough Concentrations (Cmin) Greater Than or Equal to (>=) 20 Microgram Per Milliliter (mcg/mL)||Day 43|The primary pharmacokinetic (PK) analysis population consisted of all participants with a measurable PK samples on Day 43.||percentage of participants||95% Confidence Interval|Number
688937|NCT01461044|Secondary|Percentage of Participants Who Received Induction Therapy in Combination With Bevacizumab||From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment)|Efficacy population.||percentage of participants|||Number
688938|NCT01461044|Secondary|Percentage of Participants Who Maintained Bevacizumab Beyond the First Progressive Disease||From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment)|Efficacy population. Here number of participants were those who were available for this evaluation.||percentage of participants|||Number
688939|NCT01461044|Primary|Percentage of Participants Who Received First-Line Endocrine Therapy at the Time of Local or Metastatic Progression|Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for the specified evaluation.||percentage of participants|||Number
688940|NCT01461044|Primary|Percentage of Participants With Previous and Concurrent Disease at the Time of Local or Metastatic Progression|Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for the specified evaluation.||percentage of participants|||Number
688980|NCT01460732|Primary|Awake Systolic Ambulatory Blood Pressure Measurement|An Ambulatory Blood Pressure Measurement device is applied by a doctor to each patient for 24 hours and next day it is removed. Measurements taken during patient's awake and asleep hours are analyzed separately.|2 weeks|||mmHg||Standard Deviation|Mean
688981|NCT01460732|Primary|Asleep Diastolic Home Blood Pressure Measurement|Home Blood Pressure measurement device was applied by the patient himself, in order to perform BP measurements during sleep, as per protocol.|2 weeks|||mmHg||Standard Deviation|Mean
688941|NCT01461044|Primary|Percentage of Participants With Ki67 (MiB1) at the Time of Local or Metastatic Progression|The Ki67 (MiB1) a prognostic marker, is used to evaluate the proliferative activity of breast cancer. Percentage of participants with < or >=10% and unknown were reported. Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for the specified evaluation.||percentage of participants|||Number
688942|NCT01461044|Primary|Percentage of Participants With Mitotic Index (MI) at the Time of Local or Metastatic Progression|MI is an indirect measure of cell proliferation that has been demonstrated to be a strong predictor of outcome for several human and canine cancers. Percentage of participants that reported a low, intermediate, high and unknown indices were included. Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for the specified evaluation.||percentage of participants|||Number
688943|NCT01461044|Primary|Percentage of Participants With Negative HER2 Status at the Time of Local or Metastatic Progression|Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for the specified evaluation.||percentage of participants|||Number
688944|NCT01461044|Primary|Percentage of Participants With HR Status at the Time of Local or Metastatic Progression|Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for the specified evaluation.||percentage of participants|||Number
688945|NCT01461044|Primary|Percentage of Participants With Cross Results for Both ER and PR at the Time of Local or Metastatic Progression|Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for the specified evaluation.||percentage of participants|||Number
688946|NCT01461044|Primary|Percentage of Participants With Progesterone Receptors (PR) at the Time of Local or Metastatic Progression|Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for the specified evaluation.||percentage of participants|||Number
688947|NCT01461044|Primary|Percentage of Participants With Estrogen Receptors (ER) at the Time of Local or Metastatic Progression|Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for the specified evaluation.||percentage of participants|||Number
688948|NCT01461044|Primary|Percentage of Participants With Visceral Involvement at the Time of Local or Metastatic Progression|Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population.||percentage of participants||95% Confidence Interval|Number
688949|NCT01461044|Primary|Percentage of Participants Classified Based on Number of Metastatic Sites at the Time of Local or Metastatic Progression|Percentage of participants that reported metastatic disease in less than or equal to (<=) 3 sites or greater than (>) 3 sites were assessed. Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for the evaluation of metastatic sites.||percentage of participants||95% Confidence Interval|Number
688950|NCT01461044|Secondary|Percentage of Participants With Reasons for Definitive Discontinuation||From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment)|Efficacy population. Here number of participants were those who were definitive discontinued.||percentage of participants|||Number
688951|NCT01461044|Secondary|Percentage of Participants With Definitive Discontinuation||From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment)|Efficacy population. Here number of participants were those who were temporary discontinued.||percentage of participants|||Number
688952|NCT01461044|Secondary|Percentage of Participants With Reasons for Temporary Discontinuation||From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment)|Efficacy population. Here number of participants were those who were temporary discontinued.||percentage of participants|||Number
688953|NCT01461044|Secondary|Percentage of Participants With Temporary Discontinuation||From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment)|Efficacy population. Here number of participants were those who were temporary discontinued.||percentage of participants|||Number
694325|NCT01402128|Primary|Changes in Body Fat Mass(kg)|Body fat mass(kg) was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis||kg||Standard Deviation|Mean
688955|NCT01461044|Primary|Percentage of Participants With Metastatic Disease at Identified Metastatic Sites at the Time of Local or Metastatic Progression|Metastatic diseases were identified at bone, lung, liver, central nervous system, soft tissue, lymph nodes, skin, pleura and other sites. Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population.||percentage of participants||95% Confidence Interval|Number
688956|NCT01461044|Primary|Percentage of Participants With Breast Cancer (BRCA) Mutation at the Time of Local or Metastatic Progression|Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for the evaluation of BRCA mutation.||percentage of participants|||Number
688957|NCT01461044|Primary|Mean Body Mass Index (BMI) at the Time of Local or Metastatic Progression|BMI was calculated by weight divided by height squared and measured as kilogram per square meter (kg/m^2). Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for the evaluation of BMI which was measured in kg/m^2.||kg/m^2||Standard Deviation|Mean
688958|NCT01461044|Primary|Mean Height at the Time of Local or Metastatic Progression|Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for the evaluation of height.||centimeters||Standard Deviation|Mean
688959|NCT01461044|Primary|Mean Body Weight at the Time of Local or Metastatic Progression|Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for the evaluation of body weight.||kilograms||Standard Deviation|Mean
688960|NCT01461044|Primary|Percentage of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at the Time of Local or Metastatic Progression|ECOG-PS measured on-therapy (time between first dose and last dose date with a 30-day lag) assessed participant's performance status on a 5 point scale: 0 equals (=) fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, but ambulatory/able to carry out light or sedentary work; 2=ambulatory (greater than [>] 50 percentage [%] of waking hours [h]), capable of all self care, but unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair >50% of waking hours; 4= completely disabled, cannot carry on any selfcare, totally confined to bed or chair and 5=Dead. Only participants that reported in any of the specified scale was reported. Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for the evaluation of ECOG PS.||percentage of participants|||Number
688961|NCT01461044|Primary|Percentage of Participants With Menopausal Status at the Time of Local or Metastatic Progression|Menopausal status included premenopausal and menopausal. Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for the evaluation of menopausal status.||percentage of participants|||Number
688962|NCT01461044|Primary|Mean Age at the Time of Local or Metastatic Progression|Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population.||years||Standard Deviation|Mean
688963|NCT01461044|Primary|Disease-Free Interval|Disease free interval was expressed in months: (Date of diagnosis of metastatic disease - Date of initial diagnosis + 1) / 30.4375. Disease free interval was observed retrospectively and assessed at inclusion period or baseline (the time after the retrospective phase and at the start of prospective phase).|From initial diagnosis to the diagnosis of metastatic disease (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for this outcome measure.||months||Full Range|Median
688964|NCT01461044|Primary|Percentage of Participants Who Were Disease-Free for at Least 24 Months After Initial Diagnosis|Disease free interval was expressed in months: (Date of diagnosis of metastatic disease - Date of initial diagnosis + 1) / 30.4375. Percentage of participants who were disease-free for at least 24 months were reported.|From initial diagnosis to the diagnosis of metastatic disease (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for this outcome measure.||percentage of participants||95% Confidence Interval|Number
688965|NCT01461044|Secondary|Overall Survival (OS)|OS was defined as the time between the first administration of bevacizumab and death from any cause and participants still alive at the end of the study were censored at the last consultation or last contact date.|From the first administration of bevacizumab to death from any cause (up to a maximum of 60.8 months including retrospective and prospective treatment)|Efficacy population.||months||95% Confidence Interval|Median
694326|NCT01402115|Secondary|Changes in PTH(Parathyroid Hormone)|PTH(parathyroid hormone) was measured in study visit 1(0 week) and visit 3(12 week).|12weeks|per protocol analysis||pg/mL||Standard Deviation|Mean
688967|NCT01461044|Secondary|Time to Progression|Objective tumor response was assessed using RECIST. PD was defined as the appearance of new lesion(s) or at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum obtained at Screening or during treatment. Participants who withdrew from the study early for insufficient therapeutic response without tumor assessment for PD were also included within the definition of PD. Time to progression was defined as the time from treatment start to PD. Participants who did not experience PD were censored from the last tumor assessment. Time to progression was estimated using Kaplan-Meier and expressed in months. Inclusion (baseline) here was the time after the retrospective phase and at the start of prospective phase.|From first administration of bevacizumab to inclusion in the study (up to a maximum of 42.8 months, assessed retrospectively at Baseline)|Efficacy population.||months||95% Confidence Interval|Median
688968|NCT01461044|Secondary|Progression-Free Survival|Progression-free survival was defined as the time from first dose of bevacizumab to documented PD or death from any cause, whichever occurred first. PD was defined as the appearance of new lesion(s) or at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum obtained at Screening or during treatment. Inclusion (baseline) here was the time after the retrospective phase and at the start of prospective phase.|From first administration of bevacizumab to inclusion in the study (up to a maximum of 42.8 months, assessed retrospectively at Baseline)|Efficacy population.||months||95% Confidence Interval|Median
688969|NCT01461044|Secondary|Percentage of Participants With Disease Progression or Death|"Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death). PD was defined as the appearance of new lesion(s) or at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum obtained at Screening or during treatment."|From first administration of bevacizumab to inclusion in the study (up to a maximum of 42.8 months , assessed retrospectively at Baseline)|Efficacy population.||percentage of participants|||Number
688970|NCT01461044|Secondary|Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR)|Objective tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR was defined as the disappearance of all target and non-target lesions, and confirmed PR was defined as at least at 30% decrease in the sum of the longest diameters of target lesions. Response was to be confirmed at follow-up assessment completed within 4 weeks of the first documented response. Inclusion (baseline) here was the time after the retrospective phase and at the start of prospective phase.|From first administration of bevacizumab to inclusion in the study (up to a maximum of 42.8 months , assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for the specified evaluation.||percentage of participants||95% Confidence Interval|Number
688971|NCT01461044|Primary|Percentage of Participants Who Were Disease-Free for at Least 12 Months After Initial Diagnosis|Disease free interval was expressed in months: (Date of diagnosis of metastatic disease - Date of initial diagnosis + 1) / 30.4375. Percentage of participants who were disease-free for at least 12 months were reported.|From initial diagnosis to the diagnosis of metastatic disease (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for this outcome measure.||percentage of participants||95% Confidence Interval|Number
688972|NCT01460940|Secondary|Progression-free Survival in Patients With Previously Treated Hodgkin's Lymphoma Receiving Combined Lenalidomide and Panobinostat|Determined from the date of start of therapy to death from any cause or censored at the last date the patient is known to be alive|3-5 years|||months||95% Confidence Interval|Median
688973|NCT01460940|Secondary|Assess the Safety and Tolerability of Combined Lenalidomide and Panobinostat in Patients With Previously Treated Hodgkin's Lymphoma.|Safety and tolerability will be assessed for patients using the NIH-NCI Common Terminology Criteria (CTCAE) version 4.0|up to 24 months|Grade 3-4 toxicities||percentage of patients|||Number
688974|NCT01460940|Primary|Determine the Overall Response Rate (ORR), Including Complete Responses (CR) and Partial Responses (PR)|Overall response rate (CR + PR) will be determined using the International response criteria with combined panobinostat and lenalidomide in patients with relapsed or refractory Hodgkin's lymphoma.|up to 24 months|||percentage of patients|||Number
688975|NCT01460927|Primary|Fitzpatrick Classification of Wrinkling and Degree of Elastosis.|"At each of the specified time points, photographs of the treated areas will be taken. The photography angles will include a global frontal photo and the right and left sides of the face at 45° and/or 90°. In addition, close up photos will be taken of specific facial zones, e.g., the peri orbital wrinkles.
Observing changes to the surface by visual and photographic analysis based on the score of 2-6 on the Fitzpatrick Classification of Wrinkling and Degree of Elastosis. (Lasers Surg Med 2003;33(4):232 42)
Score Wrinkling & Degree of Elastosis 1-3 Fine wrinkles (rhytides) and Mild Elastosis (fine textural changes with subtly accentuated skin lines) 4-6 Fine to moderate depth wrinkles, moderate number of lines and Moderate Elastosis (distinct papular elastosis [individual papules with yellow translucency under direct lighting] and dyschromia)"|Baseline, Pre Treatment 4, Pre Treatment 8, 1 Month FU, 3 Month FU|Per protocol||Fitzpatrick Classification Scale||Full Range|Mean
688976|NCT01460732|Secondary|Dippers Defined by ABPM and HBPM-Nocturnal|As Dippers are defined the patients who displayed a nocturnal fall (Daytime-Nighttime BP/Daytime BP) in Systolic and/or Diastolic Blood Pressure by 10% or more, by each method. The rest of patients, with a nocturnal fall by less than 10% or even a rise of BP, are consequently defined as Non-Dippers.|2 weeks|All patients who had their Daytime and Nocturnal BP assessed by both methods.||percentage of patients|||Number
688977|NCT01460732|Primary|Asleep Diastolic Ambulatory Blood Pressure Measurement|An Ambulatory Blood Pressure Measurement device is applied by a doctor to each patient for 24 hours and next day it is removed. Measurements taken during patient's awake and asleep hours are analyzed separately.|2weeks|||mmHg||Standard Deviation|Mean
688978|NCT01460732|Primary|Asleep Systolic Ambulatory Blood Pressure Measurement|An Ambulatory Blood Pressure Measurement device is applied by a doctor to each patient for 24 hours and next day it is removed. Measurements taken during patient's awake and asleep hours are analyzed separately.|2weeks|||mmHg||Standard Deviation|Mean
688979|NCT01460732|Primary|Awake Diastolic Ambulatory Blood Pressure Measurement|An Ambulatory Blood Pressure Measurement device is applied by a doctor to each patient for 24 hours and next day it is removed. Measurements taken during patient's awake and asleep hours are analyzed separately.|2 weeks|||mmHg||Standard Deviation|Mean
688985|NCT01460628|Secondary|Brown Attention Deficit Disorder Scale (BADDS)|This is a normed and validated measure of ADHD-related executive function impairments. The clinician administered scale measures five clusters of executive function including 1) organizing and activating for work, 2) sustaining attention and concentration, 3) sustaining alertness, effort, and processing speed, 4) managing affective interference, and 5) using working memory and accessing recall. The frequency and severity of each of the 40 items is rated on a scale of 0 to 3, with the total scores ranging from 0-120 and higher scores indicating worse symptoms.|4 weeks|||units on a scale||Inter-Quartile Range|Median
688986|NCT01460628|Secondary|Patient Health Questionnaire-9 (PHQ-9)|The PHQ-9 is the self-administered form of the Primary Care Evaluation of Mental Disorders (PRIME-MD), a widely used instrument designed to screen for psychiatric illnesses in primary-care settings. This 9-item instrument assesses mood, depressive symptoms, and suicidal ideation. The range of total scores is 0-27 with higher scores indicating worse symptoms. Generally, scores 5-9 indicate mild depression, 10-14 indicate moderate depression, and 15+ indicate moderately severe or severe depression.|4 weeks|||units on a scale||Inter-Quartile Range|Median
688987|NCT01460628|Secondary|Symptom Checklist-10 Anxiety|The SCL-10 anxiety subscale, developed from the refinement of the Hopkins Symptom Checklist (HSCL), consists of 10 questions focused on how much discomfort symptoms of anxiety (e.g. “nervousness or shaking inside”) have caused in the past two weeks. Each question is answered on a scale from 0-4, and answers are averaged for a total score between 0-4 with higher scores indicating more anxiety.|4 weeks|||units on a scale||Inter-Quartile Range|Median
688988|NCT01460628|Secondary|Hot Flash Frequency (24-hr Period)|The Daily Vasomotor Symptom Diary consists of a 7-day scale on which the subject records the total number of hot flushes they experience on a daily basis. Weekly averages for a 24-hour period are calculated.|4 weeks|||# of hot flashes||Inter-Quartile Range|Median
688989|NCT01460628|Secondary|Epsworth Sleepiness Scale (ESS)|This self-report scale is widely used as a subjective measure of sleepiness. This 8 item instrument yields a total score ranging from 0-24 with higher scores indicating worse symptoms.|4 weeks|||units on a scale||Inter-Quartile Range|Median
688990|NCT01460628|Primary|Brief Fatigue Inventory (BFI)|This is a widely used self-report instrument to assess the severity of fatigue and the impact of fatigue on daily functioning. This 9 item instrument yields a global fatigue score ranging from 0-10 with higher scores indicating worse symptoms. .|4 weeks|||units on a scale||Inter-Quartile Range|Median
688991|NCT01460628|Primary|Menopause Quality Of Life Questionnaire (MENQOL) Physical Domain Subscale|This is a widely used self-report instrument to determine differences in quality of life among menopausal women and to measure changes in their quality of life over time. Four domain scores are calculated from the 29-item instrument. The physical domain subscale has 16 questions and a range from 0-8 with higher scores indicating worse symptoms.|4 weeks|||units on a scale||Inter-Quartile Range|Median
688992|NCT01460446|Secondary|The Diabetes Treatment Satisfaction Questionnaire at Baseline (DTSQs) Score and the Diabetes Treatment Satisfaction Questionnaire for Change From Baseline (DTSQc) Score|"The Diabetes Treatment Satisfaction Questionnaire at Baseline (DTSQs) contains 6 items which can be scored from 0=‘very bad’ to 6=‘very good’. The total score is the sum of the scores of the 6 items and ranges from 0 to 36. A higher score indicates more satisfaction. This questionnaire was administered at Baseline only.
The Diabetes Treatment Satisfaction Questionnaire for change from Baseline (DTSQc) to study end contains 6 items which can be rated from -3=‘much worse now’ to 3=‘much better now’). The total score is the sum of the scores of the 6 items and ranges from -18 to 18. A higher score indicates more satisfaction. This questionnaire was administered at the end of the study (Week 24) only."|Baseline to Week 24|Intent-to-treat population: All randomized participants who completed the study.||Units on a scale||Standard Deviation|Mean
688993|NCT01460446|Secondary|Change in the Hypoglycemia Fear Survey (HFS-II) Score From Baseline to Week 24|The Hypoglycemia Fear Survey-II (HFS-II) contains 33 items (15 items regarding behavior and 18 items regarding worry) which can be rated from 0=‘never’ to 4=‘always’). The total HFS-II score ranges from 0 to 132 with a higher score indicating more fear. A negative change score indicates improvement.|Baseline to Week 24|Intent-to-treat population: All randomized participants who completed the study and had data available for analysis.||Units on a scale||Standard Deviation|Mean
688994|NCT01460446|Secondary|Change in the Problem Area in Diabetes (PAID) Scale Score From Baseline to Week 24|The Problem Area in Diabetes (PAID) scale contains 20 items which can be rated from 0=‘not a problem’ to 4=‘serious problem’. The total PAID scale score ranges from 0 to 80 with a higher score indicating more diabetes-related problems. A negative change score indicates improvement.|Baseline to Week 24|Intent-to-treat population: All randomized participants who completed the study and had data available for analysis.||Units on a scale||Standard Deviation|Mean
688995|NCT01460446|Secondary|Number of Participants With None, Mild, Moderate, Moderately Severe, and Severe Depression at Baseline and Week 24|The Major Depression Disorder (MDD) scale is derived from the Patient Health Questionnaire depression scale (PHQ-8) and was used to categorize participants in regard to the severity of their depression. There are 5 categories on the MDD scale: None, mild, moderate, moderately severe, and severe. The category for each participant is determined from their PHQ-8 score. A total PHQ-8 score of 0 to 4 represents no significant depressive symptoms. A total PHQ-8 score of 5 to 9 represents mild depressive symptoms; 10 to 14, moderate; 15 to 19, moderately severe; and 20 to 24, severe. A higher score indicates more depression.|Baseline to Week 24|Intent-to-treat population: All randomized participants who completed the study.||Participants|||Number
688996|NCT01460446|Secondary|Change in the Patient Health Questionnaire Depression Scale (PHQ-8) Score From Baseline to Week 24|The Patient Health Questionnaire depression scale (PHQ-8) contains 8 items which can be rated from 0='not at all' to 3='nearly every day'. The total PHQ-8 score is the sum of the responses to the 8 items and ranges from 0 to 24. A lower score indicates less depression. A negative change score indicates improvement.|Baseline to Week 24|Intent-to-treat population: All randomized participants who had data available for analysis.||Units on a scale||Standard Deviation|Mean
689006|NCT01460342|Secondary|Clinician Global Impression of Improvement (CGI-I) Scale at 12 Weeks|The CGI-I measured the clinician's perception of participant improvement at the time of assessment compared with the start of treatment. Scores were 1 (Very much better), 2 (Much improved), 3 (Minimally improved), 4 (No change), 5 (Minimally worse), 6 (Much worse), and 7 (Very much worse).|12 Weeks|Randomized participants who received at least 1 dose of study drug.||participants|||Number
725190|NCT00351273|Secondary|Health Assessment Questionnaire (HAQ)||Months 6 and 9||||||
688997|NCT01460446|Secondary|Change in Carbohydrate Counting Accuracy From Baseline to Week 24|Participants were asked to assess the carbohydrate content (grams) of 10 standardized meals by using a set of Dose Adjustment for Normal Eating (DAFNE) plates, which provide standardized photographs of meals with known carbohydrate values. The mean meal error (MME), an indicator of accuracy, and mean meal absolute error (MMAE), an indicator of variability were calculated from their responses. The MME is defined as the mean of the differences between the estimated carbohydrate content and the actual carbohydrate content over the 10 DAFNE plates. A negative MME indicates an underestimation and a positive MME indicates an overestimation of the actual carbohydrate content. The MMAE is defined as the mean of the absolute value of the differences between the estimated carbohydrate content and the actual carbohydrate content over the 10 DAFNE plates. The MMAE is ≥ 0 with a lower value indicating a better ability to estimate the actual carbohydrate content.|Baseline to Week 24|Intent-to-treat population: All randomized participants who completed the study and had data available for analysis.||Grams||Standard Deviation|Mean
688998|NCT01460446|Secondary|Correct and Incorrect Use of Insulin:Carbohydrate Ratio (I:CHO) and Insulin Sensitivity Factor (ISF) Advice by Participants Using the Aviva Nano Blood Glucose Meter During the Study|Participants using the Aviva Nano blood glucose meter received individualized advice in how to use their insulin:carbohydrate ratio (I:CHO) and insulin sensitivity factor (ISF) values to determine their insulin dose. The I:CHO ratio advice was considered to have been used correctly if the meal bolus dose the participant indicated in his/her patient diary was in accordance with the dose which could be calculated based upon the participant’s total carbohydrate intake and the I:CHO ratio. The ISF advice was considered to have been correctly used if the correction bolus dose the participant indicated in his/her patient diary was in accordance with the dose which could be calculated based upon the participant’s blood glucose target, current blood glucose value, and the ISF.|Baseline to Week 24|Intent-to-treat population: All randomized participants who completed the study. Results are only reported for participants using the Aviva Nano blood glucose meter who had data available for analysis.||Number of advices per day||Standard Deviation|Mean
688999|NCT01460446|Secondary|Number of Accu-Chek® Aviva Expert Blood Glucose Meter Bolus Advices Modified Per Day by Participants During the Study|Participants using the Accu-Chek® Aviva Expert blood glucose meter were encouraged to use the Bolus Advisor utility incorporated into the meter. A bolus opportunity occurs, for example, just before eating a meal.|Baseline to Week 24|Intent-to-treat population: All randomized participants.||Number of advices modified per day||Standard Deviation|Mean
689000|NCT01460446|Secondary|Percentage of Bolus Opportunities Where the Accu-Chek® Aviva Expert Blood Glucose Meter Bolus Advisor Was Used During the Study|Participants using the Accu-Chek® Aviva Expert blood glucose meter were encouraged to use the Bolus Advisor utility incorporated into the meter. A bolus opportunity occurs, for example, just before eating a meal.|Baseline to Week 24|Intent-to-treat population: All randomized participants.||Percentage of opportunities||Standard Deviation|Mean
689001|NCT01460446|Secondary|Change in the Mean Amplitude of Glucose Excursion (MAGE) From Baseline to Week 24|Approximately half of the investigational sites monitored glucose levels in participants enrolled in this study using the DexCom Seven® Plus Continuous Glucose Monitoring device. The device provides glucose measurements every 5 minutes for up to 7 days. The system contains a sensor, transmitter, and receiver. The sensor is a flexible round wire that goes under the skin to read glucose levels. The transmitter snaps into the sensor and wirelessly sends glucose readings to the receiver. Data was obtained from approximately one-third of participants and was used to calculate MAGE. Data were collected in the 3 days prior to Baseline and the Week 24 visit. The standard deviation of the blood glucose measurements in each 3-day period was calculated. For each glucose measurement, the difference from the previous reading was calculated. Absolute differences smaller than the standard deviation were discarded. MAGE is the mean of the remaining difference scores.|3 days prior to Baseline to Week 24|Intent-to-treat population: All randomized participants with continuous glucose monitoring data at Baseline and at Week 24 who completed the study.||mg/dL||Standard Deviation|Mean
689002|NCT01460446|Secondary|Number of Symptomatic Hypoglycemic Episodes Per Subject Year From Screening to Baseline and From Week 23 to Week 24|A symptomatic hypoglycemic episode was defined as an event with symptoms consistent with hypoglycemia which was confirmed by a blood glucose reading < 70 mg/dL (3.9 mmol/L). Symptoms might include but were not limited to sweating, dizziness, lightheadedness, tremors, nervousness, hunger, headaches, and weakness or tiredness.|Screening to Week 24|Intent-to-treat population: All randomized participants who completed the study.||Episodes per year||Standard Deviation|Mean
689003|NCT01460446|Secondary|Percentage of Blood Glucose Measurements Within the Blood Glucose Target Range From Screening to Baseline and From Week 23 to Week 24|Participants measured their blood glucose at least 3-4 times daily throughout the study. The mean blood glucose level was calculated for each 3-day period from Baseline to Week 24 and the percentage of 3-day blood glucose levels with the target range of 70-180 mg/dL (3.9-10 mmol/L) was calculated for the 2 reporting periods of Screening to Baseline and Week 23 to Week 24.|Screening to Week 24|Intent-to-treat population: All randomized participants who completed the study.||Percentage of measurements||Standard Deviation|Mean
689004|NCT01460446|Primary|Change in Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Week 24|HbA1C was measured in blood samples at a central laboratory.|Baseline to Week 24|Intent-to-treat population: All randomized participants who completed the study.||Percentage||Standard Deviation|Mean
689005|NCT01460342|Secondary|Change From Baseline in Modified International Prostate Symptom Score (mIPSS) Score at 2 Weeks|The mIPSS Total Score was the sum of Questions 1 through 7 in the mIPSS questionnaire, which was a modified version of the IPSS questionnaire. Questions about the participant's urination experiences and prostate symptoms in the IPSS questionnaire were modified to obtain responses based on time since the last visit rather than during the last month. Each question was scored from 0 (none/no symptoms) to 5 (frequent symptoms) for an mIPSS Total Score that ranged from 0 to 35; higher numerical scores represented a greater severity of symptoms. Least squares (LS) mean was based on the analysis of covariance (ANCOVA) model with treatment, prior alpha-blocker use (yes/no), and country (Japan/Korea) as fixed effects, and baseline value and placebo lead-in total IPSS change as fixed covariates.|Baseline, 2 weeks|Randomized participants who received at least 1 dose of study drug and had non-missing data at baseline.||units on a scale||Standard Error|Least Squares Mean
689073|NCT01459705|Secondary|Subjective Units of Distress (SUDs)|Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.|Treatment session 9 (week 5)||||||
689007|NCT01460342|Secondary|Patient Global Impression of Improvement (PGI-I) Scale at 12 Weeks|The PGI-I scale measured the participant's perception of improvement at the time of assessment compared with the start of treatment. Scores were 1 (Very much better), 2 (Much improved), 3 (Minimally improved), 4 (No change), 5 (Minimally worse), 6 (Much worse), and 7 (Very much worse).|12 Weeks|Randomized participants who received at least 1 dose of study drug.||participants|||Number
689008|NCT01460342|Secondary|Change From Baseline in the International Prostate Symptom Score (IPSS) Quality of Life (QoL) Index|"The IPSS QoL Index assessed the participant's response to the following question, If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?. Response options were 0 (Delighted), 1 (Pleased), 2 (Mostly satisfied), 3 (Mixed, about equally satisfied and dissatisfied), 4 (Mostly dissatisfied), 5 (Unhappy), and 6 (Terrible), for a QoL Index Score that ranged from 0 to 6. Least squares (LS) mean was based on the mixed-effect model repeated measures (MMRM) model analysis with participants as random effects, treatment, prior alpha-blocker use (yes/no), country (Japan/Korea), visit, and treatment-by-visit interaction as fixed effects, and baseline value and placebo lead-in total IPSS change as fixed covariates."|Baseline, 4 weeks, 8 weeks, 12 weeks|Randomized participants who received at least 1 dose of study drug and had non-missing data at baseline.||units on a scale||Standard Error|Least Squares Mean
689009|NCT01460342|Secondary|Change From Baseline in the International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore|The IPSS Voiding (Obstructive) Subscore was the sum of Questions 1, 3, 5, and 6 in the IPSS questionnaire. Each question was scored from 0 (no obstructive symptoms) to 5 (frequent obstructive symptoms) for an IPSS Voiding (Obstructive) Subscore that ranged from 0 to 20; higher numerical scores represented a greater severity of symptoms. Least squares (LS) mean was based on the mixed-effect model repeated measures (MMRM) model analysis with participants as random effects, treatment, prior alpha-blocker use (yes/no), country (Japan/Korea), visit, and treatment-by-visit interaction as fixed effects, and baseline value and placebo lead-in total IPSS change as fixed covariates.|Baseline, 4 weeks, 8 weeks, 12 weeks|Randomized participants who received at least 1 dose of study drug and had non-missing data at baseline.||units on a scale||Standard Error|Least Squares Mean
689010|NCT01460342|Secondary|Change From Baseline in the International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore|The IPSS Storage (Irritative) Subscore was the sum of Questions 2, 4, and 7 in the IPSS questionnaire. Each question was scored from 0 (no irritative symptoms) to 5 (frequent irritative symptoms) for an IPSS Storage (Irritative) Subscore that ranged from 0 to 15; higher numerical scores represented a greater severity of symptoms. Least squares (LS) mean was based on the mixed-effect model repeated measures (MMRM) model analysis with participants as random effects, treatment, prior alpha-blocker use (yes/no), country (Japan/Korea), visit, and treatment-by-visit interaction as fixed effects, and baseline value and placebo lead-in total IPSS change as fixed covariates.|Baseline, 4 weeks, 8 weeks, 12 weeks|Randomized participants who received at least 1 dose of study drug and had non-missing data at baseline.||units on a scale||Standard Error|Least Squares Mean
689011|NCT01460342|Secondary|Change From Baseline in Total Score of International Prostate Symptom Score (IPSS)|The IPSS Total Score was the sum of Questions 1 through 7 in the IPSS questionnaire. Each question was based on the participant's urination experiences and prostate symptoms during the last month. Scores ranged from 0 (none/no symptoms) to 5 (frequent symptoms) for an IPSS Total Score that ranged from 0 to 35; higher numerical scores represented a greater severity of symptoms. Least squares (LS) mean was based on the mixed-effect model repeated measures (MMRM) model analysis with participants as random effects, treatment, prior alpha-blocker use (yes/no), country (Japan/Korea), visit, and treatment-by-visit interaction as fixed effects, and baseline value and placebo lead-in total IPSS change as fixed covariates.|Baseline, 4 weeks, 8 weeks|Randomized participants who received at least 1 dose of study drug and had non-missing data at baseline.||units on a scale||Standard Error|Least Squares Mean
689012|NCT01460342|Primary|Change From Baseline in Total Score of International Prostate Symptom Score (IPSS) at 12 Weeks|The IPSS Total Score was the sum of Questions 1 through 7 in the IPSS questionnaire. Each question was based on the participant's urination experiences and prostate symptoms during the last month. Scores ranged from 0 (none/no symptoms) to 5 (frequent symptoms) for an IPSS Total Score that ranged from 0 to 35; higher numerical scores represented a greater severity of symptoms. Least squares (LS) mean was based on the mixed-effect model repeated measures (MMRM) model analysis with participants as random effects, treatment, prior alpha-blocker use (yes/no), country (Japan/Korea), visit, and treatment-by-visit interaction as fixed effects, and baseline value and placebo lead-in total IPSS change as fixed covariates.|Baseline, 12 weeks|Randomized participants who received at least 1 dose of study drug and had non-missing data at baseline.||units on a scale||Standard Error|Least Squares Mean
689013|NCT01460303|Secondary|Composite Satisfaction Score (CSS)|"The mean scores for the first 5 questions of the Post Operative Questionnaire were used to calculate a Composite Satisfaction Score.
Total Pain (0 none, 10 worst)
Total Catheter Related Pain Range Scale (0 none, 10 worst)
Ease of catheter use (0 easy, 10 difficult)
Feeling of frustration (0 none, 10 very much)
Limited social activities (0 none, 10 very much) All subjects were given and appointment for an outpatient voiding trial after hospital discharge. The Post Operative Questionnaire was completed by the subject one time at that appointment."|5-10 days postoperatively|||units on a scale||Standard Deviation|Mean
689014|NCT01460303|Primary|Total Catheter Related Pain|Total Catheter Related Pain Range Scale (0 = none, to 10 = worst) on the Post Operative Questionnaire All subjects were given and appointment for an outpatient voiding trial after hospital discharge. The Post Operative questionnaire was completed by the subject one time at that appointment.|5-10 days postoperatively|||units on a scale||Standard Deviation|Median
689023|NCT01460290|Secondary|Change in Cognitive Status as Measured by the Trail Making Test|The Trails test is a measure of cognitive functioning. The measure consists of two parts: A and B. In part A, participants are asked to draw a trail connecting a series of numbers in sequential order. In Part B, participants are asked to draw a trail connecting a combination of letters and numbers. The time taken to complete each task is noted as the score (e.g., 78 seconds). For Trails A, there is no upper limit on the score, as subjects are given as much time as is needed for them to complete the task. Higher scores indicate poorer cognitive functioning. In Trails B, the task is timed with an upper limit of five minutes. If, at four minutes, it is determined that the subject will not likely complete the task in the time allotted, then the task can be called off. Higher scores indicate poorer cognitive functioning.|Baseline and 12 weeks|Participants who completed cognitive scales at baseline and at Week 12 visit were analyzed.||seconds||Standard Deviation|Mean
689015|NCT01460290|Secondary|Change in Cognitive Status as Measured by the Hopkins Verbal Learning Test (HVLT)|"Evaluates cognitive functioning across domains: recall, delayed recall, retention, recognition (each scored separately). The scores given are titled: recall score, delayed recall score, retention score, recognition discrimination index. Total Recall score = items correctly recalled (0-12). Delayed Recall score = items correctly recalled following delay (0-12). Retention score = percent items recalled that were also recalled after delay (0-100). The Recognition Discrimination score = true positives minus false positives (0-12). Recall task has 12 words and involves to recall of words after all of them are read aloud to the patient. Delayed recall tasks involves the same twelve words, except recall is tasked after a 20-25 minute delay. Recognition task has 24 words. Patient evaluated on how many from original list he or she is able to recognize. Higher scores = better outcomes.
Recognition Discrimination Index appears in this entry below"|Baseline and 12 weeks|Participants who completed cognitive scales at baseline and at Week 12 visit were analyzed.||number of items||Standard Deviation|Mean
689016|NCT01460290|Secondary|Change in Cognitive Status as Measured by the Hopkins Verbal Learning Test (HVLT)|"Evaluates cognitive functioning across domains: recall, delayed recall, retention, recognition (each scored separately). The scores given are titled: recall score, delayed recall score, retention score, recognition discrimination index. Total Recall score = items correctly recalled (0-12). Delayed Recall score = items correctly recalled following delay (0-12). Retention score = percent items recalled that were also recalled after delay (0-100). The Recognition Discrimination score = true positives minus false positives (0-12). Recall task has 12 words and involves to recall of words after all of them are read aloud to the patient. Delayed recall tasks involves the same twelve words, except recall is tasked after a 20-25 minute delay. Recognition task has 24 words. Patient evaluated on how many from original list he or she is able to recognize. Higher scores = better outcomes.
Retention scores appear in this entry below."|Baseline and 12 weeks|Participants who completed cognitive scales at baseline and at Week 12 visit were analyzed.||percentage of items||Standard Deviation|Mean
689017|NCT01460290|Secondary|Change in Cognitive Status as Measured by the Hopkins Verbal Learning Test (HVLT)|"Evaluates cognitive functioning across domains: recall, delayed recall, retention, recognition (each scored separately). The scores given are titled: recall score, delayed recall score, retention score, recognition discrimination index. Total Recall score = items correctly recalled (0-12). Delayed Recall score = items correctly recalled following delay (0-12). Retention score = percent items recalled that were also recalled after delay (0-100). The Recognition Discrimination score = true positives minus false positives (0-12). Recall task has 12 words and involves to recall of words after all of them are read aloud to the patient. Delayed recall tasks involves the same twelve words, except recall is tasked after a 20-25 minute delay. Recognition task has 24 words. Patient evaluated on how many from original list he or she is able to recognize. Higher scores = better outcomes.
Delayed recall scores appear in this entry below."|Baseline and 12 weeks|Participants who completed cognitive scales at baseline and at Week 12 visit were analyzed.||correctly recalled items||Standard Deviation|Mean
689018|NCT01460290|Secondary|Assessment of Motor Control Abnormality as Measured by the Simpson Angus Scale (SAS)|The Simpson-Angus Scale is used to monitor for neurological and musculoskeletal side effects that may be a result of certain psychotropic medications. The scale consists of 10 questions which each can be rated on a scale of 0 to 4. Scores for each item are added to produce a total score. The highest possible total score is 40. Higher scores indicate more adverse outcomes.|Baseline and 12 weeks|ITT and LOCF.||units on a scale||Standard Deviation|Mean
689019|NCT01460290|Secondary|Barnes Drug-induced Akathisia Rating Scale (BARS)|This scale is used to measure the presence of akathisia, as may result from use of certain psychotropic medications. The scale contains four items and the score for each item is added to produce the total score. Total scores range from 0 to 14. Higher scores indicate more adverse outcomes.|Baseline and 12 weeks|ITT and LOCF.||units on a scale||Standard Deviation|Mean
689020|NCT01460290|Secondary|World Health Organization Disability Assessment Scale (WHO-DAS)|The WHO-DAS II is used to assess patients for difficulties that they experience due to health conditions. Six subscales are represented which cover the following domains: Getting Around (range 1-10), Self Care (range 1-10), Life Activities (range 1-20), Understand/Communicate (range 1-10), Participation in Society (range 1-10), and Getting Along with People (range 1-10). Lower scores represent more positive outcomes, while higher scores represent worse outcomes. Total summary scores were not computed for our analyses and is optional for the measure.|12 weeks|ITT and LOCF.||units on a scale||Standard Deviation|Mean
689021|NCT01460290|Secondary|Change in Cognitive Status as Measured by the Dementia Rating Scale (DRS)|The DRS contains items that evaluate cognitive function across 5 subscales: attention, initiation/perseveration, construction, conceptualization, and memory. Subscale raw score ranges are: attention (0-37), initiation/perseveration (0-37), construction (0-6), conceptualization (0-39), and memory (0-25). Raw subscale scores are added for a total raw score with range 0-144. For each raw subscale score, scaled scores are looked up from a battery of 13 tables. Age of the participant determines which table is to be used. Total raw subscale score also has its own scaled score in the tables. In addition to use in determining scaled scores for each of the subscales, these tables are used to look up the scaled score for the total raw score. The tables are contained in the article Robust and Expanded Norms for the Dementia Rating Scale (Pedraza, Lucas, et al. 2010); Archives of Clinical Neuropsychology 25; 347-358. Higher scores, raw and scaled, indicate better cognitive functioning.|Baseline and 12 weeks|Participants who completed cognitive scales at baseline and at Week 12 visit were analyzed.||units on a scale||Standard Deviation|Mean
689022|NCT01460290|Secondary|Change in Cognitive Status as Measured by the Hopkins Verbal Learning Test (HVLT)|"Evaluates cognitive functioning across domains: recall, delayed recall, retention, recognition (each scored separately). The scores given are titled: recall score, delayed recall score, retention score, recognition discrimination index. Total Recall score = items correctly recalled (0-36). Delayed Recall score = items correctly recalled following delay (0-12). Retention score = percent items recalled that were also recalled after delay (0-100). The Recognition Discrimination score = true positives minus false positives (0-12). Recall task has 12 words and involves to recall of words after all of them are read aloud to the patient. Delayed recall tasks involves the same twelve words, except recall is tasked after a 20-25 minute delay. Recognition task has 24 words. Patient evaluated on how many from original list he or she is able to recognize. Higher scores = better outcomes.
Total recall scores appear in this entry below."|Baseline and 12 weeks|Participants who completed cognitive scales at baseline and at Week 12 visit were analyzed.||correctly recalled items||Standard Deviation|Mean
689024|NCT01460290|Secondary|Change in Cognitive Status as Measured by the Stroop Task|The Stroop evaluates patients for cognitive functioning. Patients are to read words aloud or name colors as quickly as possible in a 45-second period. The measure contains three tasks, each associated with a subscale as follows: Word, Color, and Color-Word. Each subscale contains 100 items. The raw score range for each of the subscales is 0-100. Each raw subscale score is converted to a T-Score. The possible T-Score range for the Word subscale is 15 to 85. The possible T-Score range for the Color subscale is 8 to 92. The possible T-Score range for the Color-Word subscale is 3 to 98. Higher scores on the subscales indicate better cognitive functioning. Subscales are scored independently and are not added to produce a total score.|Baseline and 12 weeks|Participants who completed cognitive scales at baseline and at Week 12 visit were analyzed.||T-Score||Standard Deviation|Mean
689025|NCT01460290|Secondary|Change in Bipolar Disorder Symptoms as Measured by the Brief Psychiatric Rating Scale (BPRS)|The minimum possible score is 18 and the maximum score is 126. A higher score implies a worse condition.|Baseline and 12 weeks|ITT and LOCF.||units on a scale||Standard Deviation|Mean
689026|NCT01460290|Secondary|Change in Depressive Symptoms as Measured by the Montgomery Asberg Depression Rating Scale (MADRS)|The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition.|Baseline and 12 weeks|Participants with a baseline MADRS score of 16 or greater were analyzed. LOCF||units on a scale||Standard Deviation|Mean
689027|NCT01460290|Secondary|Change in Perception of Mental Health as Measured by the Short Form General Health Survey (SF-12)|The minimum possible score is 1 and the maximum score is 99. A higher score implies a better perceived condition.|Baseline and 12 weeks|ITT and LOCF.||units on a scale||Standard Deviation|Mean
689028|NCT01460290|Secondary|Change in Perception of Physical Health as Measured by the Short Form General Health Survey (SF-12)|The minimum possible score is 1 and the maximum score is 99. A higher score implies a better perceived condition.|Baseline and 12 weeks|ITT and LOCF.||units on a scale||Standard Deviation|Mean
689029|NCT01460290|Secondary|Change in Global Psychopathology as Measured by the Clinical Global Impression Scale for Use in Bipolar Illness (CGI-BP)|"The minimum possible score is 1 and the maximum score is 7. A higher score implies a worse condition.
The CGI-BP has three scores - Mania Severity, Depression Severity, and Overall Bipolar Illness Severity."|Baseline and 12 weeks|Intention To Treat (ITT) and LOCF||units on a scale||Standard Deviation|Mean
689030|NCT01460290|Primary|Change in Manic Symptoms as Measured by the Young Mania Rating Scale (YMRS)|The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition.|Baseline and 12 weeks|Participants with a baseline YMRS score of 12 or greater were analyzed. LOCF||units on a scale||Standard Deviation|Mean
689031|NCT01460290|Primary|Change in Depressive Symptoms as Measured by the Hamilton Depression Rating Scale (HAM-D)|The minimum possible score is 0 and the maximum score is 52. A higher score implies a worse condition.|Baseline and 12 weeks|Participants with baseline HAM-D score of 8 or greater were analyzed. Last Observational Carried Forward (LOCF).||units on a scale||Standard Deviation|Mean
689032|NCT01459913|Secondary|Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)|"AE: any adverse change from the subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Study drug includes all investigational agents administered during the course of the study."|Baseline up to Week 48|Safety set included all subjects who received at least 1 dose of study drug.||participants|||Number
689033|NCT01459913|Secondary|Number of Subjects With Extended Rapid Viral Response (eRVR)|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. eRVR was defined as undetectable HCV RNA at both 4 weeks and 12 weeks after the start of study treatment. This outcome was planned to be assessed only in “Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)” and “Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)” reporting groups.|Week 4 and Week 12|FA Set.||participants|||Number
689034|NCT01459913|Secondary|Number of Subjects With Rapid Viral Response (RVR)|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. RVR was defined as undetectable HCV RNA 4 weeks after the start of study treatment. This outcome was planned to be assessed only in “Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)” and “Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)” reporting groups.|Week 4|FA Set.||participants|||Number
689035|NCT01459913|Secondary|Percentage of Subjects With On-Treatment Virologic Failure|On-treatment virologic failure was defined as subjects who met futility (as per investigator discretion) or who completed the assigned treatment duration and had detectable HCV RNA at planned end of treatment (up to 48 weeks). This outcome was planned to be assessed in all reporting groups and results were to be reported for total arm as well.|Baseline up to Week 48|FA Set.||percentage of participants|||Number
689036|NCT01459913|Secondary|Percentage of Subjects With Viral Relapse|Viral relapse was defined as having detectable HCV RNA during antiviral follow-up in subjects who had HCV RNA less than (<) lower limit of quantification (LLOQ) at end of treatment. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The LLOQ was 25 IU/mL and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in “Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)” and “Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)” reporting groups.|After last dose of study drug up to 4 weeks (up to Week 28), 12 weeks (up to Week 36), 24 weeks (up to Week 48) antiviral follow-up|FA Set.||percentage of participants|||Number
689068|NCT01459705|Secondary|Side Effects Questionnaire|The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.|Treatment session 5 (week 2.5)||||||
689069|NCT01459705|Secondary|Side Effects Questionnaire|The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.|Treatment session 4 (week 2)||||||
689037|NCT01459913|Secondary|Percentage of Subjects With Sustained Viral Response at Week 72 (SVR72)|SVR72 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Week 72. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in “Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)” and “Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)” reporting groups.|Week 72|FA Set. Here number of subjects analyzed = subjects who were evaluable for this measure. Subjects who did not have the SVR72 assessment because they discontinued the study due to ‘Study Terminated by the Sponsor’ are excluded from this analysis.||percentage of participants|||Number
689038|NCT01459913|Secondary|Percentage of Subjects With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR24)|SVR24 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at 24 weeks after last planned dose of study treatment. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in “Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)” and “Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)” reporting groups.|24 weeks after last planned dose of study drug (up to Week 48)|FA Set.||percentage of participants|||Number
689039|NCT01459913|Secondary|Percentage of Subjects With Sustained Viral Response 4 Weeks After Last Planned Dose of Study Drug (SVR4)|SVR4 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at 4 weeks after last planned dose of study treatment. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in “Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)” and “Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)” reporting groups.|4 weeks after last planned dose of study drug (up to Week 28)|FA Set.||percentage of participants|||Number
689040|NCT01459913|Primary|Percentage of Subjects With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12)|SVR12 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at 12 weeks after last planned dose of study drug. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in “Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)” and “Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)” reporting groups.|12 weeks after last planned dose of study drug (up to Week 36)|Full Analysis (FA) Set.||percentage of participants|||Number
689041|NCT01459796|Secondary|Percentage of Participants With Rescue Medication From Day 1 to Day 364 (Week 52)|Participants who required rescue medication after having 2 or more gout flares during the treatment period were evaluated.|Day 1 to Day 364 (Week 52)|Safety analysis set (SAF) that included all randomized participants who received any study medication and was based on the treatment received (as treated).||percentage of participants|||Number
689042|NCT01459796|Secondary|Percentage of Participants With at Least Two Gout Flares From Day 1 to Day 364 (Week 52)|Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain, and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Percentage of participants with at least two gout flares at Week 52 was to be reported for this outcome measure.|Day 1 to Day 364 (Week 52)|As per sponsor's discretion, the study was discontinued due to which data for this outcome measure was not collected and hence, not analyzed and reported.|||||
689043|NCT01459796|Secondary|Percentage of Participants With at Least One Gout Flare From Day 1 to Day 364 (Week 52)|Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain; and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Percentage of participants with at least one gout flare at Week 52 was to be reported for this outcome measure.|Day 1 to Day 364 (Week 52)|As per sponsor's discretion, the study was discontinued due to which data for this outcome measure was not collected and hence, not analyzed and reported.|||||
689044|NCT01459796|Secondary|Percentage of Participants With at Least Two Gout Flares From Day 1 to Day 168 (Week 24)|Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain, and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Percentage of participants with at least two gout flares at Week 24 was to be reported for this outcome measure.|Day 1 to Day 168 (Week 24)|As per sponsor's discretion, the study was discontinued due to which data for this outcome measure was not collected and hence, not analyzed and reported.|||||
689045|NCT01459796|Secondary|Percentage of Participants With at Least One Gout Flare From Day 1 to Day 168 (Week 24)|Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain; and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Percentage of participants with at least one gout flare at Week 24 was to be reported for this outcome measure.|Day 1 to Day 168 (Week 24)|As per sponsor's discretion, the study was discontinued due to which data for this outcome measure was not collected and hence, not analyzed and reported.|||||
689070|NCT01459705|Secondary|Side Effects Questionnaire|The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.|Treatment session 3 (week 2)||||||
689071|NCT01459705|Secondary|Side Effects Questionnaire|The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.|Treatment session 2 (week 1)||||||
699165|NCT01347840|Secondary|Percent Weight Loss|(Weight at Baseline – Weight at Each Visit) divided by the (Weight at Baseline).|16 Months|||percentage of weight loss|||Number
689046|NCT01459796|Primary|Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)|Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment period (time from the administration of first dose of study drug up to and including 35 days after the last dose of study drug). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.|Day 1 to Day 392 (Week 56)|Safety analysis set (SAF) that included all randomized participants who received any study medication and was based on the treatment received (as treated).||percentage of participants|||Number
689047|NCT01459783|Secondary|Change in Process Measures of Dementia Care Quality at 6 and 12 Months|The investigators will collect caregiver survey identified care process measures to assess which medical care processes that are specific to dementia occurred as a potential mediator of change in outcomes.|0, 6 and 12 months||||||
689048|NCT01459783|Secondary|Change in Care Recipient Quality of Life at 6 and 12 Months|The investigators will evaluate patient health-related quality of life (HRQOL) by proxy (caregiver) assessment using the 15-item Health Utilities Index (HUI2), a generic health state classification system with preference-based utility weights derived from the general population. The HUI is one of the more widely used utility measures and has been used in previous studies of elderly with dementia and their caregivers.|0, 6 and 12 months||||||
689049|NCT01459783|Secondary|Change in Caregiver Quality of Life at 6 and 12 Months|The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia, incorporates non-health related issues as well as positive aspects of caregiving, and has demonstrated feasibility as a phone-based instrument in both English and Spanish. Eighty items are distributed across 10 scales: assistance with ADLs, assistance with IADLs, personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving.|0, 6 and 12 months||||||
689050|NCT01459783|Secondary|Change in Caregiver Depression at 6 and 12 Months|"The Patient Health Questionnaire - Nine (PHQ-9) is a 9-item self-report measure of depressive symptoms over the previous 2 weeks. The PHQ-9 is the depression module of the PRIME- MD diagnostic instrument for common mental disorders. It covers each of the 9 DSM-IV depression criteria scoring them as 0 (not at all) to 3 (nearly every day)."|0, 6 and 12 months||||||
689051|NCT01459783|Primary|Change in Care Recipient Memory and Problem Behaviors at 6 and 12 Months|The Revised Memory and Behavior Problem Checklist (RMBPC) was developed by Teri and colleagues. The RMBPC instrument assess 24 care receiver problems in the areas of behavior, memory, and depression and whether each behavior had occurred in the prior week. Higher RMBPC scores mean worse memory/behavior problems. The minimum possible score for number of problems is zero, and the maximum score for number of problems is 24.|0, 6 and 12 months|||units on a scale||Standard Deviation|Mean
689052|NCT01459783|Primary|Change in Caregiver Burden at 6 and 12 Months|The Zarit Burden Interview (BI) is a widely used validated measure to assess stressors experienced by caregivers of persons with dementia. Originally a 29-item instrument, the 22-item modified version is easily completed by telephone. This instrument covers five constructs of burden: health, psychological well-being, finances, social life, and relationship with impaired person and an overall summary score of caregiver burden. Higher Zarit scores indicate greater caregiver burden. The minimum possible score is 0, and the maximum possible score is 110.|0, 6 and 12 months|||units on a scale||Standard Deviation|Mean
689053|NCT01459705|Secondary|Intent to Attend|This is a measure to assess the intent to complete study procedures.|2.5 weeks (or after treatment session 5)||||||
689054|NCT01459705|Secondary|Intent to Attend|This is a measure to assess the intent to complete study procedures.|Treatment session 10 (week 5)||||||
689055|NCT01459705|Secondary|Intent to Attend|This is a measure to assess the intent to complete study procedures.|Treatment session 9 (week 5)||||||
689056|NCT01459705|Secondary|Intent to Attend|This is a measure to assess the intent to complete study procedures.|Treatment session 8 (week 4)||||||
689057|NCT01459705|Secondary|Intent to Attend|This is a measure to assess the intent to complete study procedures.|Treatment session 7 (week 4)||||||
689058|NCT01459705|Secondary|Intent to Attend|This is a measure to assess the intent to complete study procedures.|Treatment session 6 (week 3)||||||
689059|NCT01459705|Secondary|Intent to Attend|This is a measure to assess the intent to complete study procedures.|Treatment session 5 (week 2.5)||||||
689060|NCT01459705|Secondary|Intent to Attend|This is a measure to assess the intent to complete study procedures.|Treatment session 4 (week 2)||||||
689061|NCT01459705|Secondary|Intent to Attend|This is a measure to assess the intent to complete study procedures.|Treatment session 3 (week 2)||||||
689062|NCT01459705|Secondary|Intent to Attend|This is a measure to assess the intent to complete study procedures.|Treatment session 2 (week 1)||||||
689063|NCT01459705|Secondary|Side Effects Questionnaire|The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.|Treatment session 10 (week 5)||||||
689064|NCT01459705|Secondary|Side Effects Questionnaire|The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.|Treatment session 9 (week 5)||||||
689065|NCT01459705|Secondary|Side Effects Questionnaire|The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.|Treatment session 8 (week 4)||||||
689066|NCT01459705|Secondary|Side Effects Questionnaire|The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.|Treatment session 7 (week 4)||||||
689067|NCT01459705|Secondary|Side Effects Questionnaire|The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.|Treatment session 6 (week 3)||||||
689074|NCT01459705|Secondary|Subjective Units of Distress (SUDs)|Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.|Treatment session 8 (week 4)||||||
689075|NCT01459705|Secondary|Subjective Units of Distress (SUDs)|Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.|Treatment session 7 (week 4)||||||
689076|NCT01459705|Secondary|Subjective Units of Distress (SUDs)|Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.|Treatment session 6 (week 3)||||||
689077|NCT01459705|Secondary|Subjective Units of Distress (SUDs)|Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.|Treatment session 5 (week 2.5)||||||
689078|NCT01459705|Secondary|Subjective Units of Distress (SUDs)|Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.|Treatment session 4 (week 2)||||||
689079|NCT01459705|Secondary|Subjective Units of Distress (SUDs)|Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.|Treatment session 3 (week 2)||||||
689080|NCT01459705|Secondary|Subjective Units of Distress (SUDs)|Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.|Treatment session 2 (week 1)||||||
689081|NCT01459705|Secondary|BASIS-24|To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.|26 week follow up||||||
689082|NCT01459705|Secondary|BASIS-24|To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.|12 week follow up||||||
689083|NCT01459705|Secondary|BASIS-24|To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.|2.5 weeks (or after treatment session 5)||||||
689084|NCT01459705|Secondary|BASIS-24|To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.|5 weeks (or after treatment session 10)||||||
689085|NCT01459705|Secondary|BASIS-24|To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.|Treatment session 10 (week 5)||||||
689086|NCT01459705|Secondary|BASIS-24|To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.|Treatment session 9 (week 5)||||||
689087|NCT01459705|Secondary|BASIS-24|To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.|Treatment session 8 (week 4)||||||
689088|NCT01459705|Secondary|BASIS-24|To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.|Treatment session 7 (week 4)||||||
689089|NCT01459705|Secondary|BASIS-24|To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.|Treatment session 6 (week 3)||||||
689090|NCT01459705|Secondary|BASIS-24|To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.|Treatment session 5 (week 2.5)||||||
689091|NCT01459705|Secondary|BASIS-24|To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.|Treatment session 4 (week 2)||||||
689092|NCT01459705|Secondary|BASIS-24|To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.|Treatment session 3 (week 2)||||||
689093|NCT01459705|Secondary|BASIS-24|To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.|Treatment session 2 (week 1)||||||
689094|NCT01459705|Secondary|Beck Anxiety Inventory (BAI)|The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.|26 week follow up||||||
689095|NCT01459705|Secondary|Beck Anxiety Inventory (BAI)|The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.|12 week follow up||||||
689096|NCT01459705|Secondary|Beck Anxiety Inventory (BAI)|The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.|5 weeks (or after treatment session 10)||||||
689097|NCT01459705|Secondary|Beck Anxiety Inventory (BAI)|The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.|2.5 weeks (or after treatment session 5)||||||
689098|NCT01459705|Secondary|Suicide Risk Assessment|Due to the nature of the questions, this is deemed to be of safety nature.|26 Week follow up||||||
689099|NCT01459705|Secondary|Suicide Risk Assessment|Due to the nature of the questions, this is deemed to be of safety nature.|12 Week follow up||||||
689100|NCT01459705|Secondary|Suicide Risk Assessment|Due to the nature of the questions, this is deemed to be of safety nature.|5 weeks (or after treatment session 10)||||||
689101|NCT01459705|Secondary|Suicide Risk Assessment|Due to the nature of the questions, this is deemed to be of safety nature.|2.5 weeks (or after treatment session 5)||||||
689102|NCT01459705|Secondary|Perceived Stigma Measure (PSS)|Stigma will be measured using a 5 question assessment scale.|26 week follow up||||||
689103|NCT01459705|Secondary|Perceived Stigma Measure (PSS)|Stigma will be measured using a 5 question assessment scale.|12 week follow up||||||
689104|NCT01459705|Secondary|Perceived Stigma Measure (PSS)|Stigma will be measured using a 5 question assessment scale.|5 weeks (or after treatment session 10)||||||
689105|NCT01459705|Secondary|Perceived Stigma Measure (PSS)|Stigma will be measured using a 5 question assessment scale.|2.5 weeks (or after treatment session 5)||||||
699166|NCT01347840|Secondary|Body Mass Index|Will be calculated at Screening, Visit 3, Visit 5, Visit 6, Visit 8, and Visit 10.|16 Months|||units on a scale|||Number
689106|NCT01459705|Secondary|Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS)|The IASMHS is a 24 item assessment of help-seeking attitudes. It includes the following three factors based on components of Ajzen's Theory of Planned Behavior: Psychological Openness, Help-seeking Propensity and Indifference to Stigma.|26 Week follow up||||||
689107|NCT01459705|Secondary|Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS)|The IASMHS is a 24 item assessment of help-seeking attitudes. It includes the following three factors based on components of Ajzen's Theory of Planned Behavior: Psychological Openness, Help-seeking Propensity and Indifference to Stigma.|12 Week follow up||||||
689108|NCT01459705|Secondary|Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS)|The IASMHS is a 24 item assessment of help-seeking attitudes. It includes the following three factors based on components of Ajzen's Theory of Planned Behavior: Psychological Openness, Help-seeking Propensity and Indifference to Stigma.|5 weeks (or after treatment session 10)||||||
689109|NCT01459705|Secondary|Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS)|The IASMHS is a 24 item assessment of help-seeking attitudes. It includes the following three factors based on components of Ajzen's Theory of Planned Behavior: Psychological Openness, Help-seeking Propensity and Indifference to Stigma.|2.5 weeks (or after treatment session 5)||||||
689110|NCT01459705|Secondary|Beck Depression Inventory-II (BDI-II)|This self report measure of depression contains 21 items that are rated on a 4 point scale.|26 Week follow up||||||
689111|NCT01459705|Secondary|Beck Depression Inventory-II (BDI-II)|This self report measure of depression contains 21 items that are rated on a 4 point scale.|12 Week follow up||||||
689112|NCT01459705|Secondary|Beck Depression Inventory-II (BDI-II)|This self report measure of depression contains 21 items that are rated on a 4 point scale.|5 weeks (or after treatment session 10)||||||
689113|NCT01459705|Secondary|Beck Depression Inventory-II (BDI-II)|This self report measure of depression contains 21 items that are rated on a 4 point scale.|2.5 weeks (or after treatment session 5)||||||
689114|NCT01459705|Secondary|Primary Care PTSD Screen (PC-PTSD)|The PC-PTSD is a four-item measure designed to screen for PTSD.|26 Week follow up||||||
689115|NCT01459705|Secondary|Primary Care PTSD Screen (PC-PTSD)|The PC-PTSD is a four-item measure designed to screen for PTSD.|12 Week follow up||||||
689116|NCT01459705|Secondary|Primary Care PTSD Screen (PC-PTSD)|The PC-PTSD is a four-item measure designed to screen for PTSD.|5 weeks (or after treatment session 10)||||||
689117|NCT01459705|Secondary|PTSD Checklist (PCL-C)|The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale.|26 week follow up||||||
689118|NCT01459705|Secondary|PTSD Checklist (PCL-C)|The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale.|12 week follow up||||||
689119|NCT01459705|Secondary|Primary Care PTSD Screen (PC-PTSD)|The PC-PTSD is a four-item measure designed to screen for PTSD.|2.5 weeks (or after treatment session 5)||||||
689120|NCT01459705|Secondary|PTSD Checklist (PCL-C)|The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale.|5 weeks (or after treatment session 10)||||||
689121|NCT01459705|Secondary|PTSD Checklist (PCL-C)|The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale.|2.5 weeks (or after treatment session 5)||||||
689122|NCT01459705|Secondary|Intent to Attend|This is a measure to assess the intent to complete study procedures.|Treatment session 1 (week 1)||||||
689123|NCT01459705|Secondary|BASIS-24|To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.|Treatment session 1 (week 1)||||||
689124|NCT01459705|Secondary|Side Effects Questionnaire|The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.|Treatment session 1(week 1)||||||
689125|NCT01459705|Secondary|Subjective Units of Distress (SUDs)|Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.|Treatment session 1 (week 1)||||||
689126|NCT01459705|Secondary|Intent to Attend|This is a measure to assess the intent to complete study procedures.|Screening Visit (Day 1)||||||
689127|NCT01459705|Secondary|Behavior and Sympton Identification Scale (BASIS-24)|To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.|Screening Visit(Day 1)||||||
689128|NCT01459705|Secondary|Beck Anxiety Inventory (BAI)|The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.|Screening Visit(Day 1)||||||
689129|NCT01459705|Secondary|Suicide Risk Assessment|Due to the nature of the questions, this is deemed to be of safety nature.|Screening Visit(Day 1)||||||
689130|NCT01459705|Secondary|Perceived Stigma Measure (PSS)|Stigma will be measured using a 5 question assessment scale.|Screening Visit(Day 1)||||||
689131|NCT01459705|Secondary|Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS)|The IASMHS is a 24 item assessment of help-seeking attitudes. It includes the following three factors based on components of Ajzen's Theory of Planned Behavior: Psychological Openness, Help-seeking Propensity and Indifference to Stigma.|Screening Visit(Day 1)||||||
689132|NCT01459705|Secondary|Beck Depression Inventory-II (BDI-II)|This self report measure of depression contains 21 items that are rated on a 4 point scale.|Screening Visit(Day 1)||||||
689133|NCT01459705|Secondary|Primary Care PTSD Screen (PC-PTSD)|The PC-PTSD is a four-item measure designed to screen for PTSD.|Screening Visit (Day 1)||||||
689134|NCT01459705|Secondary|PTSD Checklist- Civilian (PCL-C)|The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale.|Screening Visit (Day 1)||||||
689135|NCT01459705|Primary|Clinician-Administered PTSD Scale (CAPS)|The CAPS is a structured interview that assesses all DSM-IV PTSD criteria in terms of frequency and intensity. Scores are computed for Intrusion, Avoidance and Hyperarousal symptom clusters, as well as a Total score.We used total scores as the primary outcome. Minimum possible score was 0, maximum possible score was 136. Higher scores indicated higher levels of symptoms.|26 Week follow up|||units on a scale||Standard Deviation|Mean
689654|NCT01456130|Secondary|Percentage of Participants With a Clinical Response|Clinical response is defined as an HbA1c level less than 5.8% or less than 6.5% at Week 52 or at the final visit.|Week 52|Full analysis set||percentage of participants||95% Confidence Interval|Number
689136|NCT01459705|Primary|Clinician-Administered PTSD Scale (CAPS)|The CAPS is a structured interview that assesses all DSM-IV PTSD criteria in terms of frequency and intensity. Scores are computed for Intrusion, Avoidance and Hyperarousal symptom clusters, as well as a Total score.We used total scores as the primary outcome. Minimum possible score was 0, maximum possible score was 136. Higher scores indicated higher levels of symptoms.|12 week follow up|||units on a scale||Standard Deviation|Mean
689137|NCT01459705|Primary|Clinician-Administered PTSD Scale (CAPS)|The CAPS is a structured interview that assesses all DSM-IV PTSD criteria in terms of frequency and intensity. Scores are computed for Intrusion, Avoidance and Hyperarousal symptom clusters, as well as a Total score.We used total scores as the primary outcome. Minimum possible score was 0, maximum possible score was 136. Higher scores indicated higher levels of symptoms.|5 weeks (or after treatment session 10)|Participants who provided outcome data at post treatment||units on a scale||Standard Deviation|Mean
689138|NCT01459705|Primary|Clinician-Administered PTSD Scale (CAPS)|The CAPS is a structured interview that assesses all DSM-IV PTSD criteria in terms of frequency and intensity. Scores are computed for Intrusion, Avoidance and Hyperarousal symptom clusters, as well as a Total score.We used total scores as the primary outcome. Minimum possible score was 0, maximum possible score was 136. Higher scores indicated higher levels of symptoms.|2.5 weeks (or after treatment session 5)|Participants who provided data at mid treatment||units on a scale||Standard Deviation|Mean
689139|NCT01459705|Primary|Clinician-Administered PTSD Scale (CAPS)|The CAPS is a structured interview that assesses all Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) PTSD criteria in terms of frequency and intensity. We used total scores as the primary outcome. Minimum possible score was 0, maximum possible score was 136. Higher scores indicated higher levels of symptoms.|Screening Visit (Day 1)|Baseline scores on the CAPS-W (last week reference)||units on scale||Standard Deviation|Mean
689140|NCT01459653|Secondary|Patient-level Predictor for Cancer-related Mortality|"Objective 10: To model patient- and center-level variables between patients who died vs. survived during the course of primary or secondary prophylaxis with EP2006 in all patients and those with break-through FN episodes.
Table presents patient level predictors for cancer-related mortality: female gender, poor performance (ECOG >=2) during study.
ECOG score is a severity scale from 0 to 5 (highest) to grade toxicity and is defined as follows: 0=none, 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=lethal. ECOG is described in more detail by Oken et al, Am J Clin Oncol (CCT) 5:649-655, 1982."|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample with data||participants|||Number
689141|NCT01459653|Primary|Incidence of Outcomes|"Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment.
Table presents incidences of different outcomes and composite outcome by chemotherapy risk group. ^Composite endpoint includes any of CIN grade 4, FN, CIN/FN-related hospitalization and CIN/FN-related chemotherapy disturbance.
CIN: Chemotherapy-Induced Neutropenia; FN: Febrile Neutropenia; ANC: Absolute Neutrophil count; GIS: GCSF Initiation Score; Prophylaxis decision mentioned below are relative to EORTC guidelines (2010)."|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample||percentage of participants|||Number
689142|NCT01459653|Primary|EP2006 Cycles by Treatment Duration|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|All cycles from patients in the evaluable sample with study drug duration||cycles|Participants||Number
689143|NCT01459653|Primary|EP2006 Day of Initiation: Cycle Distribution|"Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
Table presents number of cycles by day after chemotherapy."|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Cycles of patients in evaluable sample with day of study drug initiation||cycles|Participants||Number
689144|NCT01459653|Secondary|Patient-level Predictors for All-cause Mortality|"Objective 10: To model patient- and center-level variables between patients who died vs. survived during the course of primary or secondary prophylaxis with EP2006, in all patients and those with break-through FN episodes.
Table presents patient-level predictors for all-cause mortality: history of anemia at enrollment, liver/renal/cardiac comorbidity, poor performance (ECOG >=2) during study"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample with data||participants|||Number
689145|NCT01459653|Secondary|Modeling Composite Outcome (Any of CIN Grade 4, FN, CIN/FN-related Hospitalization, CIN/FN-related Chemotherapy Disturbance): Patient Level|"Objective 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006.
Objective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006.
Only results with a p-value of <0.05 are shown in the statistical appendices.
CI: confidence interval; CIN: chemotherapy-induced neutropenia; ECOG: Eastern Cooperative Oncology Group; FN: febrile neutropenia; GCSF: granulocyte colony-stimulating factor; GIS: GCSF Initiation Score. H/o repeated infections refers at enrollment; H/o: History of"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Patients in evaluable sample with composite outcome data||participants|||Number
689146|NCT01459653|Secondary|Modeling Composite Outcome (Any of CIN Grade 4, FN, CIN/FN-related Hospitalization, CIN/FN-related Chemotherapy Disturbance): Cycle Level|"Objective 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006.
Objective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006.
Only results with a p-value of <0.05 are shown in the statistical appendices.
CI: confidence interval; CIN: chemotherapy-induced neutropenia; ECOG: Eastern Cooperative Oncology Group; FN: febrile neutropenia; GCSF: granulocyte colony-stimulating factor; GIS: GCSF Initiation Score."|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Cycles of patients from evaluable sample with composite outcome data||cycles|Participants||Number
689147|NCT01459653|Secondary|Modeling CIN/FN-related Chemotherapy Disturbance: Patient Level (Patient-level Predictors)|"Objective 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006.
Objective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006.
Only results with a p-value of <0.05 are shown in the statistical appendices.
CI: confidence interval; CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample with CIN/FN-related chemotherapy disturbance data||cycles|||Number
689148|NCT01459653|Secondary|Modeling CIN/FN-related Chemotherapy Disturbance: Cycle Level|"Objective 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006.
Objective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006.
Only results with a p-value of <0.05 are shown in the statistical appendices.
CI: confidence interval; CIN: chemotherapy-induced neutropenia; GCSF: granulocyte colony-stimulating factor; GIS: GCSF Initiation Score; Chemotherapy disturbance=dose reduction, delay, and/or cancellation"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Cycles of patients in evaluable sample with CIN/FN-related chemotherapy disturbance with data||cycles|Participants||Number
689149|NCT01459653|Secondary|Modeling CIN/FN-related Hospitalization: Patient Level|"Objective 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006.
Objective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006.
Only results with a p-value of <0.05 are shown in the statistical appendices.
CI: confidence interval; CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia; ECOG: Eastern Cooperative Oncology Group."|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample with CIN/FN-related hospitalization data||participants|||Number
689150|NCT01459653|Secondary|Modeling CIN/FN-related Hospitalization: Cycle Level|"Objective 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006.
Objective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006.
Only results with a p-value of <0.05 are shown in the statistical appendices.
CI: confidence interval; CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia; ECOG: Eastern Cooperative Oncology Group."|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Number of cycles of patients in evaluable sample with CIN/FN-related hospitalization data||cycles|Participants||Number
689151|NCT01459653|Secondary|Modeling FN Episode: Patient Level|"Objective 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006.
Objective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006
Only results with a p-value of <0.05 are shown in the statistical appendices.
CI: confidence interval; CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample with FN episode data||participants|||Number
689159|NCT01459653|Primary|Patient/Center-level Covariance Parameter Estimates of Absolute Neutrophil Count|"Objective 6: To examine the multilevel determinants (patient, center) of hematological outcomes of primary and secondary prophylaxis with EP2006 to better understand the variability in outcomes achieved.
Mean and standard error estimated from ANCOVA"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample||participants|Participants||Number
690093|NCT01451554|Secondary|Weight Change at 3 Months|Percentage change in weight at 3 months post study baseline|3 months|Intent to treat population includes all randomzied subjects. Missing data were imputed using the last observation carried forward.||percentage||Standard Deviation|Mean
689152|NCT01459653|Secondary|Modeling FN Episode: Cycle Level|"Objective 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006.
Objective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006.
Only results with a p-value of <0.05 are shown in the statistical appendices.
CI: confidence interval; CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia; ECOG: Eastern Cooperative Oncology Group"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Number of cycles of patients in evaluable sample with FN episode data||cycles|Participants||Number
689153|NCT01459653|Secondary|Modeling Grade 4 CIN Episode: Patient Level|"Objective 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006.
Objective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006
Only results with a p-value of <0.05 are shown in the statistical appendices.
H/o=History of; CI=confidence interval; CIN=chemotherapy-induced neutropenia"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample with data||participants|||Number
689154|NCT01459653|Secondary|Modeling Grade 4 CIN Episode: Cycle Level|"Objective 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006.
Objective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006
Only results with a p-value of <0.05 are added as statistical analyses appendices.
CI: confidence interval; CIN: chemotherapy-induced neutropenia; GCSF: granulocyte colony-stimulating factor; GIS: GCSF Initiation Score"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Number of cycles in evaluable sample with any grade 4 CIN data||cycles|Participants||Number
689155|NCT01459653|Secondary|Characteristics of Clusters: Liver, Renal and/or Cardiovascular Disease|"Objective 7: To identify different latent clusters of end-stage cancer patients receiving chemotherapy and being treated with EP2006 for the treatment or primary or secondary prophylaxis of FN using statistical data-mining techniques to profile patients based on medical history, concomitant comorbid conditions, and current clinical status.
FN=Febrile Neutropenia"|Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|"A two-group solution converged and the groups differentiated on key baseline variables. However, the group sizes were too unevenly distributed for further analysis with the high risk group comprised of only 3.0% of the evaluable sample.
Only patients with data in each group are analyzed for liver, renal and/or cardiovascular disease."||participants|||Number
689156|NCT01459653|Secondary|Characteristics of Clusters: History of Antibiotic Use for CIN|"Objective 7: To identify different latent clusters of end-stage cancer patients receiving chemotherapy and being treated with EP2006 for the treatment or primary or secondary prophylaxis of FN using statistical data-mining techniques to profile patients based on medical history, concomitant comorbid conditions, and current clinical status.
CIN=Chemotherapy Induced Neutropenia; FN=Febrile Neutropenia"|Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|"A two-group solution converged and the groups differentiated on key baseline variables. However, the group sizes were too unevenly distributed for further analysis with the high risk group comprised of only 3.0% of the evaluable sample.
Only patients with data in each group are analyzed for history of antibiotic use for CIN."||participants|||Number
689157|NCT01459653|Secondary|Characteristics of Clusters: Cancer Stage|"Objective 7: To identify different latent clusters of end-stage cancer patients receiving chemotherapy and being treated with EP2006 for the treatment or primary or secondary prophylaxis of FN using statistical data-mining techniques to profile patients based on medical history, concomitant comorbid conditions, and current clinical status.
FN=Febrile Neutropenia"|Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|"A two-group solution converged and the groups differentiated on key baseline variables. However, the group sizes were too unevenly distributed for further analysis with the high risk group comprised of only 3.0% of the evaluable sample.
Only patients with data in each group are analyzed for cancer stage."||participants|||Number
689158|NCT01459653|Secondary|Characteristics of Clusters: ECOG Performance Status|"Objective 7: To identify different latent clusters of end-stage cancer patients receiving chemotherapy and being treated with EP2006 for the treatment or primary or secondary prophylaxis of FN using statistical data-mining techniques to profile patients based on medical history, concomitant comorbid conditions, and current clinical status.
ECOG score is a severity scale from 0 to 5 (highest) to grade toxicity and is defined as follows: 0=none, 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=lethal. ECOG is described in more detail by Oken et al, Am J Clin Oncol (CCT) 5:649-655, 1982.
FN=Febrile Neutropenia; ECOG: European Cooperative Oncology Group"|Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|"A two-group solution converged and the groups differentiated on key baseline variables. However, the group sizes were too unevenly distributed for further analysis with the high risk group comprised of only 3.0% of the evaluable sample.
Only patients with data in each group are analyzed for ECOG performance status."||Scores on a scale||Standard Deviation|Mean
690094|NCT01451541|Secondary|Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation||Weeks 0 -12|||percentage of subjects|||Number
689160|NCT01459653|Primary|Predictors of Absolute Neutrophil Count|"Objective 6: To examine the multilevel determinants (patient, center) of hematological outcomes of primary and secondary prophylaxis with EP2006 to better understand the variability in outcomes achieved.
Hierarchical modeling was used to test the relationship of patient- and physician/center-level variables and treatment response in terms of ANC. This analysis was conducted at the cycle level using a 1-cycle lag between treatment patterns and outcomes, that is study drug treatment patterns in one cycle predicted the ANC value at the beginning of the next cycle. Log-transformed ANC values were used.
Table presents predictors for ANC: GCSF decision, study drug dose, tumor type, patient gender, ECOG, Hb
Since log-transformed Absolute Neutrophil Count (ANC) values were used, Exp(beta) can be interpreted in terms of % change in ANC for each unit change in predictor or for each category relative to the referent (for categorical variables); Hb=Hemoglobin"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Cycles for patients in evaluable sample with data||participants|Participants||Number
689161|NCT01459653|Primary|Number of Participants With Any CIN/FN-related Chemotherapy Disturbance by Treatment Decision|"Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment.
Table presents number of patients with any CIN/FN-related chemotherapy disturbances by treatment decision.
CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by treatment decision with data||participants|||Number
689162|NCT01459653|Primary|Number of Participants With Any CIN/FN-related Chemotherapy Disturbance by Prophylaxis Type|"Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment.
Table presents number of patients with any CIN/FN-related chemotherapy disturbance by prophylaxis type.
CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by prophylaxis type||participants|||Number
689163|NCT01459653|Primary|Number of Participants With Cancer-related Mortality by Any CIN/FN-related Chemotherapy Disturbance|"Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment.
Table presents number of patients who had a cancer-related death by any/no CIN/FN-related chemotherapy disturbance
CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by any/no CIN/FN-related chemotherapy disturbance with data||participants|||Number
689164|NCT01459653|Primary|Number of Participants With Cancer-related Mortality by Any/no Grade 4 CIN or FN|"Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment.
Table presents number of patients that had a cancer-related death by any/no grade 4 CIN or FN
CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by any/no grade 4 CIN or FN with data||participants|||Number
689165|NCT01459653|Primary|Number of Participants With All-cause Mortality by CIN/FN-related Chemotherapy Disturbance|"Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment.
Table shows number of patients who died by any or no CIN/FN related chemotherapy disturbance.
CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by any or no CIN/FN related chemotherapy disturbance.||participants|||Number
689166|NCT01459653|Primary|Number of Participants With All-cause Mortality by Any/no Grade 4 CIN and/or FN|"Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment.
Table shows number of patients that died in each group.
CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by any/no grade 4 CIN/FN||participants|||Number
689198|NCT01459653|Primary|EP2006 Treatment Duration in Cycle 3|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 3. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Cycles of participants in evaluable sample with study drug duration in cycle 3||days|Participants|Standard Deviation|Mean
689167|NCT01459653|Primary|Number of Patients by Cause of Death|Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Safety population, i.e. all patients who received at least one dose of study drug||participants|||Number
689168|NCT01459653|Primary|Incidence of Outcomes by Study Drug Duration: Cycle Level|"Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment.
Table presents incidences of outcomes on a cycle level by study drug duration. ^Composite outcome includes CIN grade 4, FN, CIN/FN-related hospitalization and CIN/FN-related chemotherapy disturbance
CIN: Chemotherapy-Induced Neutropenia; FN: Febrile Neutropenia;"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by study drug duration. As these are cycle-level analyses and since patients can be in more than one category over the course of the study, the sum of patients of all three categories may exceed the sample size.||percentage of participants|||Number
689169|NCT01459653|Primary|Incidence of Outcomes by Day of Study Drug Initiation: Cycle Level|"Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment.
Table presents incidences of outcomes on a cycle level by day of study drug initiation. ^Composite outcome includes CIN grade 4, FN, CIN/FN-related hospitalization and CIN/FN-related chemotherapy disturbance
CIN: Chemotherapy-Induced Neutropenia; FN: Febrile Neutropenia; ANC: Absolute Neutrophil count; GIS: GCSF Initiation Score; Prophylaxis decision mentioned below are relative to EORTC guidelines (2010). *Day of EP2006 initiation- Day 0 (during chemotherapy); **Day of EP2006 initiation- Days 1-3 (per guidelines)"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by day of study drug initiation. As these are cycle-level analyses and since patients can be in more than one category over the course of the study, the sum of patients of all three categories may exceed the sample size.||percentage of participants|||Number
689170|NCT01459653|Primary|Incidence of Outcomes: Cycles Level|"Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment.
Table presents incidences of outcomes on a cycle level. ^Composite outcome includes CIN grade 4, FN, CIN/FN-related hospitalization and CIN/FN-related chemotherapy disturbance
CIN: Chemotherapy-Induced Neutropenia; FN: Febrile Neutropenia; ANC: Absolute Neutrophil count; GIS: GCSF Initiation Score; Prophylaxis decision mentioned below are relative to EORTC guidelines (2010)."|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|||Percentage of participants|||Number
689171|NCT01459653|Primary|Incidence of Outcomes by Mean GIS: Patient Level|"Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment.
Table presents incidences of outcomes by day (mean GIS over all visits). ^Composite outcome includes CIN grade 4, FN, CIN/FN-related hospitalization and CIN/FN-related chemotherapy disturbance
CIN: Chemotherapy-Induced Neutropenia; FN: Febrile Neutropenia; ANC: Absolute Neutrophil count; GIS: GCSF Initiation Score; Prophylaxis decision mentioned below are relative to EORTC guidelines (2010)."|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by mean GIS||percentage of participants|||Number
689172|NCT01459653|Primary|Incidence of CIN Grade 4 Episodes by EP2006 Dose: Patient Level|"Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment.
CIN: Chemotherapy-Induced Neutropenia; FN: Febrile Neutropenia; ANC: Absolute Neutrophil count; GIS: GCSF Initiation Score; Prophylaxis decision mentioned below are relative to EORTC guidelines (2010)."|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by study drug dose||percentage of participants|||Number
689181|NCT01459653|Primary|GCSF Persistence Score (GPS)|"Objective 3: To determine the extent to which the primary and secondary prophylaxis of FN in cancer patients is in congruence with the EORTC best practice guidelines and dosing recommendations, and whether this is associated with better outcomes.
The GPS grades persistence based on the number of cycles in the line of chemotherapy in which EP2006 was administered, D, relative to the number of cycles in which it should have been continued, C. Thus, the GPS = D/C and ranges from 0 to 1.0
ANC=Absolute Neutrophil Count; CIN=Chemotherapy-Induced Neutropenia; EORTC=European Organization for Research and Treatment in Cancer; FN=Febrile Neutropenia; GCSF=Granulocyte Colony-Stimulating Factor"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Patients in the evaluable sample with a GCSF persistence score (GPS).||participants|||Number
689173|NCT01459653|Primary|Incidence of CIN/FN-related Hospitalization Outcomes by EP2006 Practice Patterns (Relative to Guidelines): Patient Level|"Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment.
Table presents incidences of different outcomes and composite outcome by prophylaxis decision (relative to guidelines). ^Composite endpoint includes any of CIN grade 4, FN, CIN/FN-related hospitalization and CIN/FN-related chemotherapy disturbance.
CIN: Chemotherapy-Induced Neutropenia; FN: Febrile Neutropenia; ANC: Absolute Neutrophil count; GIS: GCSF Initiation Score; Prophylaxis decision mentioned below are relative to EORTC guidelines (2010)."|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by prophylaxis decision (relative to guidelines)||percentage of participants|||Number
689174|NCT01459653|Primary|Incidence of CIN/FN-related Chemotherapy Disturbance by EP2006 Prophylaxis Type: Patient Level|"Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment.
CIN: Chemotherapy-Induced Neutropenia; FN: Febrile Neutropenia; ANC: Absolute Neutrophil count; GIS: GCSF Initiation Score; Prophylaxis decision mentioned below are relative to EORTC guidelines (2010)."|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by prophylaxis type||Percentage of participants|||Number
689175|NCT01459653|Primary|Incidence of Outcomes by Chemotherapy Risk: Patient Level|"Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment.
Table presents incidences of different outcomes and composite outcome by chemotherapy risk group. ^Composite endpoint includes any of CIN grade 4, FN, CIN/FN-related hospitalization and CIN/FN-related chemotherapy disturbance.
CIN: Chemotherapy-Induced Neutropenia; FN: Febrile Neutropenia; ANC: Absolute Neutrophil count; GIS: GCSF Initiation Score; Prophylaxis decision mentioned below are relative to EORTC guidelines (2010)."|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by chemotherapy risk||percentage of participants|||Number
689176|NCT01459653|Primary|CIN/FN Episodes: Cycle Level|"Objective 4: To describe hematological outcomes observed in association with primary and secondary prophylactic use of EP2006 in patients at risk for FN; including break-through episodes of FN.
Chemotherapy-Induced Neutropenia (CIN); Febrile Neutropenia (FN); Chemotherapy disturbance=dose reduction, delay, and/or cancellation; Composite (any of CIN grade 4, FN, CIN/FN-related hospitalization [RH] or CIN/FN-related chemotherapy disturbance [RCD])"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Number of cycles in evaluable sample||cycles|Participants||Number
689177|NCT01459653|Primary|Number of Patients With CIN/FN Episodes: Patient Level|"Objective 4: To describe hematological outcomes observed in association with primary and secondary prophylactic use of EP2006 in patients at risk for FN; including break-through episodes of FN.
CIN: Chemotherapy-Induced Neutropenia; FN: Febrile Neutropenia; Chemotherapy disturbance=dose reduction, delay, and/or cancellation; Composite (any of CIN grade 4, FN, CIN/FN-related hospitalization or CIN/FN-related chemotherapy disturbance)
A patient may fall into more than one or none of the categories displayed."|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|||participants|||Number
689178|NCT01459653|Primary|Absolute Neutrophil Count (ANC) Across All Cycles|Objective 4: To describe hematological outcomes observed in association with primary and secondary prophylactic use of EP2006 in patients at risk for FN; including break-through episodes of FN.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|||Per mm^3|Participants|Standard Deviation|Mean
689179|NCT01459653|Primary|Absolute Neutrophil Count (ANC) at EP2006 Initiation|Objective 4: To describe hematological outcomes observed in association with primary and secondary prophylactic use of EP2006 in patients at risk for FN; including break-through episodes of FN.|Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Number of patients in evaluable sample with initial ANC result||Per mm^3||Standard Deviation|Mean
689180|NCT01459653|Primary|GCSF Congruence Score (GCS)|"Objective 3: To determine the extent to which the primary and secondary prophylaxis of FN in cancer patients is in congruence with the EORTC best practice guidelines and dosing recommendations, and whether this is associated with better outcomes.
The GCS is computed at the patient level as an overall grade of how congruent actual GCSF treatment is to recommended treatment. The GCS is computed as follows and scores range from 0 to 3: GCS = Σ(CRS + mean GIS over all cycles + GPS), with higher scores indicating higher congruence.
CRS: Chemotherapy Risk Score (0 or 1 with 1 best); FN: febrile neutropenia; GCSF: granulocyte colony-stimulating factor; GIS=GCSF Initiation Score (0 to 1 with 1 best); GPS=GCSF persistence score (0 to 1 with 1 best);"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample with GCSF congruence score by tumor type||scores on a scale||Standard Deviation|Mean
690095|NCT01451541|Secondary|Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation||Weeks 0 -12|||participants|||Number
689182|NCT01459653|Primary|GCSF Initiation Score (GIS)|"Objective 3: To determine the extent to which the primary and secondary prophylaxis of FN in cancer patients is in congruence with the EORTC best practice guidelines and dosing recommendations, and whether this is associated with better outcomes.
ANC=Absolute Neutrophil Count; GIS Score 0 (EP2006 initiated on day 0 of chemotherapy or on day 10 or later); GIS Score 0.50 (EP2006 initiated on days 7-9 of chemotherapy); GIS Score 0.75 (EP2006 initiated on days 4-6 of chemotherapy); GIS Score 1.00 (EP2006 initiated per EORTC guidelines (2010) on days 1-3 after chemotherapy)
ANC=Absolute Neutrophil Count; CIN=Chemotherapy-Induced Neutropenia; EORTC=European Organization for Research and Treatment in Cancer; FN=Febrile Neutropenia; GCSF=Granulocyte Colony-Stimulating Factor; GIS=Granulocyte Colony-Stimulating Factor Initiation Score"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|The evaluable sample consists of all patients who received at least one dose of study medication, had no major protocol violation and have a minimum of enrollment cycle and either one follow-up cycle or study end data with valid outcome data (i.e., ANC or completed CIN/FN data)||Percent of participants|||Number
689183|NCT01459653|Primary|EP2006 Day of Initiation Relative to Guidelines by Cancer Type|"Objective 3: To determine the extent to which the primary and secondary prophylaxis of FN in cancer patients is in congruence with the EORTC best practice guidelines and dosing recommendations, and whether this is associated with better outcomes.
^ 168 cycles in which ZARZIO® was initiated on day 4 or later involved regimens deemed by the Study Steering Committee to be suitable for GCSF initiation any day after chemotherapy (day 1 or later), e.g., etoposide; hence, these patients were re-classified as being within guidelines
DLBCL- Diffuse Large B-Cell Lymphoma. Guidelines refers to EORTC 2010 guidelines"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Number of cycles with initiation on different days during chemotherapy for evaluable sample. A patient may have initiated EP2006 during chemotherapy on different days for different cycles. The categories therefore are not mutually exclusive on a patient level and the sum of patients may therefore exceed the sample size.||cycles|Participants||Number
689184|NCT01459653|Primary|Percentage of Patients With Each Chemotherapy Risk Score (CRS) Result by Tumor Type|"Objective 3: To determine the extent to which the primary and secondary prophylaxis of FN in cancer patients is in congruence with the EORTC best practice guidelines and dosing recommendations, and whether this is associated with better outcomes.
The CRS quantifies whether the decision to initiate EP2006 as either primary or secondary prophylaxis is consistent with the EORTC guideline (2010) recommendation based upon the patient’s chemotherapy toxicity (<10%, 10–20% or >20% risk of FN) and the PRS. There are three possible results: under-treated, correctly treated, over-treated"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample: total and by tumor type||percentage of patients|||Number
689185|NCT01459653|Primary|Percentage of Patients With Each Prophylaxis Decision by Chemotherapy-associated FN Risk|"Objective 3: To determine the extent to which the primary and secondary prophylaxis of FN in cancer patients is in congruence with the EORTC best practice guidelines and dosing recommendations, and whether this is associated with better outcomes.
FN: Febrile Neutropenia; EORTC: European Organisation for Research and Treatment of Cancer"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|||percentage of participants|||Number
689186|NCT01459653|Primary|Patient Risk Score (PRS) for Patients Receiving Chemotherapy With 10-20% FN Risk by Tumor Type|"Objective 3: To determine the extent to which the primary and secondary prophylaxis of FN in cancer patients is in congruence with the EORTC best practice guidelines and dosing recommendations, and whether this is associated with better outcomes.
Patient risk score (PRS) shows the individual patient risk for FN.The PRS is a sum of eight weighted individual patient risk factors for FN and results in a possible score of 0 to 11 (highest risk for FN). The risk factors were assigned weights based on the level of risk specified by guidelines and SC consensus (age > 65 years: 3.0; advanced disease: 1.5; history of FN: 3.0; No antibiotic prophylaxis: 0.5; poor performance/nutritional status: 1.5; female gender: 0.5; Hb<12g/dL: 0.5; Renal, CV or liver disease: 0.5).
Advanced disease: Stage IV or Stage III + prior chemotherapy in metastatic setting; CV: cardiovascular; EORTC: European Organization for Research and Treatment in Cancer; FN: febrile neutropenia"|Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Patients with chemotherapy with 10-20% risk of FN in the evaluable sample by tumor type||Scores on a scale||Standard Deviation|Mean
689187|NCT01459653|Primary|Patient Risk Score (PRS) for All Patients|"Objective 3: To determine the extent to which the primary and secondary prophylaxis of FN in cancer patients is in congruence with the EORTC best practice guidelines and dosing recommendations, and whether this is associated with better outcomes.
Patient risk score (PRS) shows the individual patient risk for FN.The PRS is a sum of eight weighted individual patient risk factors for FN and results in a possible score of 0 to 11 (highest risk for FN). The risk factors were assigned weights based on the level of risk specified by guidelines and SC consensus (age > 65 years: 3.0; advanced disease: 1.5; history of FN: 3.0; No antibiotic prophylaxis: 0.5; poor performance/nutritional status: 1.5; female gender: 0.5; Hb<12g/dL: 0.5; Renal, CV or liver disease: 0.5).
Advanced disease: Stage IV or Stage III + prior chemotherapy in metastatic setting; CV: cardiovascular; EORTC: European Organization for Research and Treatment in Cancer; FN: febrile neutropenia"|Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Evaluable sample||Scores on a scale||Standard Deviation|Mean
689224|NCT01459653|Primary|Concomitant Antibiotic Prophylaxis|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|||participants|||Number
689188|NCT01459653|Secondary|Characteristics of Clusters: Hemoglobin Study Start|Objective 7: To identify different latent clusters of end-stage cancer patients receiving chemotherapy and being treated with EP2006 for the treatment or primary or secondary prophylaxis of FN using statistical data-mining techniques to profile patients based on medical history, concomitant comorbid conditions, and current clinical status.|Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|"A two-group solution converged and the groups differentiated on key baseline variables. However, the group sizes were too unevenly distributed for further analysis with the high risk group comprised of only 3.0% of the evaluable sample.
Only patients with data in each group are analyzed for hemoglobin at study start."||g/dL||Standard Deviation|Mean
689189|NCT01459653|Secondary|Cohort Identification|"Objective 7: To identify different latent clusters of end-stage cancer patients receiving chemotherapy and being treated with EP2006 for the treatment or primary or secondary prophylaxis of FN using statistical data-mining techniques to profile patients based on medical history, concomitant comorbid conditions, and current clinical status.
A two-group solution converged and the groups differentiated on key baseline variables. However, the group sizes were too unevenly distributed for further analysis with the “high risk group” comprised of only 3.0% of the evaluable sample.
ANC=Absolute Neutrophil Count; CIN=Chemotherapy-Induced Neutropenia; FN=Febrile Neutropenia"|Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|The evaluable sample consists of all patients who received at least one dose of study medication, had no major protocol violation and have a minimum of enrollment cycle and either one follow-up cycle or study end data with valid outcome data (i.e., ANC or completed CIN/FN data).||participants|||Number
689190|NCT01459653|Primary|Percentage of Patients With Each EORTC-identified Risk Factors for FN in Patients With Chemotherapy Risk 10–20% at Baseline|"Objective 3: To determine the extent to which the primary and secondary prophylaxis of FN in cancer patients is in congruence with the EORTC best practice guidelines and dosing recommendations, and whether this is associated with better outcomes.
* Advanced disease is defined as Stage IV (Stage III or IV if multiple myeloma) AND prior chemotherapy in metastatic setting CV: cardiovascular; EORTC: European Organization for Research and Treatment in Cancer; FN: febrile neutropenia; Hb: hemoglobin"|Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Patients with chemotherapy risk 10–20% in evaluable sample||percentage of patients|||Number
689191|NCT01459653|Primary|Percentage of Patients With Each EORTC-identified Risk Factors for FN at Baseline|"Objective 3: To determine the extent to which the primary and secondary prophylaxis of FN in cancer patients is in congruence with the EORTC best practice guidelines and dosing recommendations, and whether this is associated with better outcomes.
* Advanced disease is defined as Stage IV (Stage III or IV if multiple myeloma) AND prior chemotherapy in metastatic setting. The PRS is a quantification of eight individual patient risk factors (EORTC guidelines-2010).
CV: cardiovascular; EORTC: European Organization for Research and Treatment in Cancer; FN: febrile neutropenia; Hb: hemoglobin"|Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Evaluable sample||percentage of participants|||Number
689192|NCT01459653|Primary|EP2006 Duration by Chemotherapy Toxicity: Cycle Level|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|||days|Participants|Standard Deviation|Mean
689193|NCT01459653|Primary|EP2006 Duration by Prophylaxis Type: Cycle Level|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|||days|Participants|Standard Deviation|Mean
689194|NCT01459653|Primary|EP2006 Duration by Tumor Type: Cycle Level|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by tumor type with data||days|Participants|Standard Deviation|Mean
689195|NCT01459653|Primary|EP2006 Treatment Duration in Cycle 6|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 6. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Cycles of participants in evaluable sample with study drug duration in cycle 6||days|Participants|Standard Deviation|Mean
689196|NCT01459653|Primary|EP2006 Treatment Duration in Cycle 5|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 5. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Cycles of participants in evaluable sample with study drug duration in cycle 5||days|Participants|Standard Deviation|Mean
689197|NCT01459653|Primary|EP2006 Treatment Duration in Cycle 4|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 4. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Cycles of participants in evaluable sample with study drug duration in cycle 4||days|Participants|Standard Deviation|Mean
689199|NCT01459653|Primary|EP2006 Treatment Duration in Cycle 2|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 2. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Cycles of participants in evaluable sample with study drug duration in cycle 2||days|Participants|Standard Deviation|Mean
689200|NCT01459653|Primary|EP2006 Treatment Duration in Cycle 1|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 1. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Cycles of participants in evaluable sample with study drug duration in cycle 1||days|Participants|Standard Deviation|Mean
689201|NCT01459653|Primary|EP2006 Treatment Duration in Any Cycle|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|All cycles from patients in the evaluable sample with study drug duration||days|Participants|Standard Deviation|Mean
689202|NCT01459653|Primary|EP2006 Day of Initiation by Chemotherapy Toxicity: Cycle Level|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|||days|Participants|Standard Deviation|Mean
689203|NCT01459653|Primary|EP2006 Day of Initiation by Prophylaxis Type: Cycle Level|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|||days|Participants|Standard Deviation|Mean
689204|NCT01459653|Primary|EP2006 Day of Initiation by Tumor Type (Solid Tumor vs. Hematological Tumor): Cycle Level|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|||days|Participants|Standard Deviation|Mean
689205|NCT01459653|Primary|EP2006 Day of Initiation: Cycle 6|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 6. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Cycles of patients in evaluable sample with study drug initiation day at cycle 6||days|Participants|Standard Deviation|Mean
689206|NCT01459653|Primary|EP2006 Day of Initiation: Cycle 5|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 5. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Cycles of patients in evaluable sample with study drug initiation day at cycle 5||days|Participants|Standard Deviation|Mean
689207|NCT01459653|Primary|EP2006 Day of Initiation: Cycle 4|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 4. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Cycles of patients in evaluable sample with study drug initiation day at cycle 4||days|Participants|Standard Deviation|Mean
689208|NCT01459653|Primary|EP2006 Day of Initiation: Cycle 3|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 3. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Cycles of patients in evaluable sample with study drug initiation day at cycle 3||days|Participants|Standard Deviation|Mean
689209|NCT01459653|Primary|EP2006 Day of Initiation: Cycle 2|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 2. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Cycles of patients in evaluable sample with study drug initiation day at cycle 2||days|Participants|Standard Deviation|Mean
689210|NCT01459653|Primary|EP2006 Day of Initiation: Cycle 1|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 1. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Cycles of patients in evaluable sample with study drug initiation day at cycle 1||days|Participants|Standard Deviation|Mean
689225|NCT01459653|Primary|Type of EP 2006 Prophylaxis by Tumor Type|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by tumor type||participants|||Number
689211|NCT01459653|Primary|EP2006 Day of Initiation: All Cycles|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Cycles of patients in evaluable sample with day of initiation of study drug||days|Participants|Standard Deviation|Mean
689212|NCT01459653|Primary|EP2006 Dose by Chemotherapy Toxicity: Cycle Level|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|||cycles|Participants||Number
689213|NCT01459653|Primary|Patient Weight by Tumor Type (Solid Tumor vs. Hematological Tumor)|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by tumor type||participants|||Number
689214|NCT01459653|Primary|EP2006 Dose by Tumor Type: Cycle Level|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|||cycles|Participants||Number
689215|NCT01459653|Primary|EP2006 Dose by Patient Weight: Cycle Level|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|All cycles treated||cycles|Participants||Number
689216|NCT01459653|Primary|EP2006 Dose (Cycle 6)|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 6. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Number of participants at cycle 6 with dose data||participants|||Number
689217|NCT01459653|Primary|EP2006 Dose (Cycle 5)|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 5. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Number of participants at cycle 5 with dose data||participants|||Number
689218|NCT01459653|Primary|EP2006 Dose (Cycle 4)|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 4. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Number of participants at cycle 4 with dose data||participants|||Number
689219|NCT01459653|Primary|EP2006 Dose (Cycle 3)|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 3. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Number of participants at cycle 3 with dose data||participants|||Number
689220|NCT01459653|Primary|EP2006 Dose (Cycle 2)|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 2. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Number of participants at cycle 2 with dose data||participants|||Number
689221|NCT01459653|Primary|EP2006 Dose (Cycle 1)|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 1. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Number of participants at cycle 1 with dose data||participants|||Number
689222|NCT01459653|Primary|EP2006 Dose (Enrollment Cycle)|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Number of participants at enrollment cycle with dose data||participants|||Number
689223|NCT01459653|Primary|EP2006 Dose (All Cycles)|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|All cycles from patients in the evaluable sample||cycles|Participants||Number
689249|NCT01459016|Secondary|Baseline Brain Amyloid Load Using Positron Emission Tomography (PET) and Florbetapir|Composite summary standardized uptake value ratio (SUVR) normalized to mean whole cerebellum. Regions used for composite summary were posterior cingulum, anterior cingulum, parietal cortex, lateral temporal cortex and frontal cortex.|Baseline|All participants with an amyloid positive florbetapir F 18 PET scan at baseline.||SUVR unit 1||Standard Deviation|Mean
689226|NCT01459653|Primary|Type of EP 2006 Prophylaxis by Age Group|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by age||participants|||Number
689227|NCT01459653|Primary|Type of EP2006 Prophylaxis by Gender|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by gender||participants|||Number
689228|NCT01459653|Primary|Type of EP2006 Prophylaxis|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|"Delayed Primary: EP2006 initiated in cycle 2 or later with no CIN/FN in prior cycle.
True secondary: EP2006 initiated in cycle 2 or later following CIN/FN in prior cycle."||participants|||Number
689229|NCT01459653|Primary|Clinical Events Ever During Study (Frequency Threshold: 5%)|"Objective 1: To describe the cancer patients requiring chemotherapy who, in their treating physician’s best clinical judgment, are receiving EP2006 for the primary or secondary prophylaxis of FN in terms of demographics, clinical status, medical history, concomitant comorbid conditions and current status of disease, and prior and concomitant medications.
ANC=Absolute Neutrophil Count; CIN=Chemotherapy-Induced Neutropenia; FN=Febrile Neutropenia"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|The evaluable sample includes all patients in the safety sample (all patients who received at least one dose of the study medication) who had no major protocol violation and have a minimum of enrollment cycle and either one follow-up cycle or study end data with valid outcome data (i.e., ANC or completed CIN/FN data)||participants|||Number
689230|NCT01459653|Primary|Fever and Infections Ever During the Study|"Objective 1: To describe the cancer patients requiring chemotherapy who, in their treating physician’s best clinical judgment, are receiving EP2006 for the primary or secondary prophylaxis of FN in terms of demographics, clinical status, medical history, concomitant comorbid conditions and current status of disease, and prior and concomitant medications.
ANC=Absolute Neutrophil Count; CIN=Chemotherapy-Induced Neutropenia; FN=Febrile Neutropenia;"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable consists of all patients who received at least one dose of study drug, who had no major protocol violations and have a minimum of enrollment cycle and either one follow-up cycle or study end data with valid outcome data (i.e. ANC or completed CIN/FN data).||participants|||Number
689231|NCT01459653|Primary|Cancer Treatment Type - Ever Received During Study|"Objective 1: To describe the cancer patients requiring chemotherapy who, in their treating physician’s best clinical judgment, are receiving EP2006 for the primary or secondary prophylaxis of FN in terms of demographics, clinical status, medical history, concomitant comorbid conditions and current status of disease, and prior and concomitant medications.
ANC=Absolute Neutrophil Count; CIN=Chemotherapy-Induced Neutropenia; FN=Febrile Neutropenia;"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|The evaluable sample includes all patients in the safety sample (all patients who received at least one dose of the study medication) who had no major protocol violation and have a minimum of enrollment cycle and either one follow-up cycle or study end data with valid outcome data (i.e., ANC or completed CIN/FN data).||participants|||Number
689232|NCT01459653|Primary|Chemotherapy Toxicity (%FN Risk)|"Objective 1: To describe the cancer patients requiring chemotherapy who, in their treating physician’s best clinical judgment, are receiving EP2006 for the primary or secondary prophylaxis of FN in terms of demographics, clinical status, medical history, concomitant comorbid conditions and current status of disease, and prior and concomitant medications.
Chemotherapy regimens were classified for FN risk (<10% risk, 10-20% risk or >20% risk) according to the published rates in the EORTC Guidelines under consideration of agent(s) and schedules.
ANC=Absolute Neutrophil Count; CIN=Chemotherapy-Induced Neutropenia; FN=Febrile Neutropenia;"|Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|The evaluable sample includes all patients in the safety sample (all patients who received at least one dose of the study medication) who had no major protocol violation and have a minimum of enrollment cycle and either one follow-up cycle or study end data with valid outcome data. Please refer to baseline characteristics tables as well.||participants|||Number
689233|NCT01459588|Secondary|Change From Baseline in Schirmer Test Results|The Schirmer Test measures the rate of the secretion of tears produced by the eye over 5 minutes. The results indicate the presence of dry eye (Normal = greater than or equal to 10 millimeters (mm) of tears, Dry Eye = less than 10 mm of tears). The smaller the number, the more severe the dry eye. The worse eye at baseline is used to calculate the change at Day 30. A positive number change from baseline indicates an increase in tears (improvement).|Baseline, Day 30|Intent-to-treat population included all randomized participants.||millimeters||Standard Deviation|Mean
689246|NCT01459016|Secondary|Change From Baseline in the Mini Mental State Examination (MMSE) Total Score|The MMSE is a brief screening instrument used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, and copy figures). Total score ranges from 0 to 30; lower score indicates greater disease severity. LS mean value was controlled for baseline value and visit.|Baseline, 6 Mos; Baseline, 12 Mos|All participants who enrolled in the study and completed the scale at the designated time point.||units on a scale||95% Confidence Interval|Least Squares Mean
689234|NCT01459588|Secondary|Change From Baseline in Conjunctival Staining|The conjunctiva is the clear membrane covering the white surface of the eye. Conjunctival staining following ocular administration of lissamine green dye was graded using a 6-point scale (0=no staining, 5=severe staining) over 6 areas of the white part of the eye for a minimum score of 0 and a maximum score of 30. The higher the score, the worse the dry eye condition. The worse eye at baseline is used to calculate the change at Day 30. A negative number change from baseline represents a decrease in the severity of conjunctival staining (improvement).|Baseline, Day 30|Intent-to-treat population included all randomized participants.||Score on as scale||Standard Deviation|Mean
689235|NCT01459588|Secondary|Change From Baseline in Corneal Staining|The cornea is the transparent front part of the eye which covers the iris and pupil. Corneal staining following administration of fluorescein dye in the eye is graded using a 6-point scale (0= no staining, 5 = severe staining) over 5 areas of the clear central part of the eye for a minimum score of 0 and a maximum score of 25. The higher the grade score, the worse the dry eye condition. The worse eye at baseline is used to calculate the change at Day 30. A negative number change from baseline represents a decrease in corneal staining (improvement).|Baseline, Day 30|Intent-to-treat population included all randomized participants.||Score on a scale||Standard Deviation|Mean
689236|NCT01459588|Secondary|Change From Baseline in Tear Break-up Time|Tear Break-up Time (TBUT) was assessed at Baseline and Day 30. TBUT is the time in seconds required for dry spots to appear on the corneal surface after blinking. The shorter the tear break-up time, the worse the dry eye. The worse eye at baseline is used to calculate the change at Day 30. A positive change from baseline indicates improvement.|Baseline, Day 30|Intent-to-treat population included all randomized participants.||Seconds||Standard Deviation|Mean
689237|NCT01459588|Primary|Change From Baseline in Ocular Surface Disease Index© Questionnaire Score|The Ocular Surface Disease Index© Questionnaire is a 12-item survey assessing the overall severity of dry eye disease per patient. Each question is rated on a 5-point scale ranging from 0=none of the time to 4=all of the time for a total possible score of 0=No disease to 100=Maximum severity of disease. A negative change from baseline indicates improvement.|Baseline, Day 30|Intent-to-treat population included all randomized participants.||Score on a scale||Standard Deviation|Mean
689238|NCT01459068|Secondary|Alcohol Use|Alcohol use was measured using the Alcohol Use Disorders Identification Test (AUDIT). Respondents reported frequency and amount of alcohol consumed, referencing photographs of local alcohols (local beers, rice whiskeys, etc.). Total scores were calculated as sum totals across the 10-item scale. AUDIT total scores ranged from 0 (best possible outcome) to 40 (worst possible outcome).|10-16 weeks|||units on a scale||Standard Error|Mean
689239|NCT01459068|Secondary|Aggression Behaviors|The 12-item Aggression Questionnaire (AQ) was adapted for local use. Respondents rated frequency in general of aggressive behaviors from 0 “None of the time” to 4 “Almost all of the time.” Scores were calculated as averages scores for each behavior across the 12-item scale and therefore ranged from 0-4|10-16 weeks|||units on a scale||Standard Error|Mean
689240|NCT01459068|Secondary|Anxiety Symptoms|Anxiety symptoms were measured using the 10-item HSCL-25 anxiety subscale with local adaptations. Respondent instructions and response categories were the same as the HSCL-25 depression subscale. Scores were calculated as average symptom scores across the 11-item scale and therefore ranged from 0-4|10-16 weeks|||units on a scale||Standard Error|Mean
689241|NCT01459068|Primary|Posttraumatic Stress Symptoms|Posttraumatic stress symptoms (PTSS) were measured using the 30-symptom items of the Harvard Trauma Questionnaire (HTQ). Response options were the same as the HSCL-25. An algorithm was applied to the HTQ to determine eligibility on the basis of moderate to severe PTSS. The HTQ was also used to measure the PTSS severity outcome: Scores for PTSS were calculated as average symptom scores across the 30 items. PTSS scores ranged from 0 (best possible outcome) to 3 (worst possible outcome).|10-16 weeks|||units on a scale||Standard Error|Mean
689242|NCT01459068|Secondary|Functional Impairment|Functional impairment was measured using locally-developed, gender-specific scales. The scales contained 16 and 23 tasks for men and women, respectively. Respondents reported current difficulty compared to others of same gender and similar age (from 0 “No difficulty” to 4 “Often cannot do”). Scores were calculated as average task scores across the 16- and 23-item scales and therefore ranged from 0-4|10-16 weeks|||units on a scale||Standard Error|Mean
689243|NCT01459068|Primary|Depression|Depression symptoms were measured using a modified, locally validated version of the 15-item Hopkins Symptoms Checklist (HSCL-25) depression subscale. Respondents reported symptom frequency in the last month (0 “None of the time” to 3 “Almost always”). An algorithm was applied to the HSCL-25 to determine eligibility on the basis of moderate to severe depression. The HSCL-25 was also used to measure the depression severity outcome: Scores on the depression scale were calculated as average symptom scores across the 17 items and therefore ranged from 0-3|10-16 weeks|||units on a scale||Standard Error|Mean
689244|NCT01459016|Secondary|Change From Baseline in the Clinical Dementia Rating (CDR) Total Score|The CDR is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; Total score ranges from 0 to 18. Higher scores indicate greater disease severity. LS mean value was controlled for baseline value and visit.|Baseline, 6 Mos; Baseline, 12 Mos|All participants who enrolled in the study and completed the scale at the designated time point.||units on a scale||95% Confidence Interval|Least Squares Mean
689245|NCT01459016|Secondary|Change From Baseline in the Alzheimer’s Disease Assessment Scale Extended Cognitive Subscale (ADAS-Cog14) Total Score|The ADAS-Cog14 is the ADAS-Cog11 augmented with delayed free recall, digit cancellation, and maze completion measures. A score of 0 to 10 for delayed free recall and a conversion code of 0 to 5 for digit cancellation and maze completion provide total score ranges for this extended ADAS-Cog14 of 0 to 90. Higher scores indicate greater disease severity. LS mean value was controlled for baseline value and visit.|Baseline, 6 Mos; Baseline, 12 Mos|All participants who enrolled in the study and completed the scale at the designated time point.||units on a scale||95% Confidence Interval|Least Squares Mean
689247|NCT01459016|Secondary|Number of Participants With Microhemorrhage on MRI Scan at a Field Strength of 3T||Baseline, 6 Mos; Baseline, 12 Mos|All participants who enrolled in the study and had an evaluable MRI at the designated time point.||participants|||Number
689248|NCT01459016|Secondary|Number of Participants With Vasogenic Edema on MRI Scan at a Field Strength of 3 Tesla (3T)||Baseline|All participants who had an MRI during screening and were classified as screen failures.||participants|||Number
689250|NCT01459016|Primary|Change From Baseline in Diffusion Tensor Imaging (DTI) Using Mean Diffusivity (MD)|DTI scans used MD to measure the overall magnitude of water diffusion in selected WM tracts, without specific regard to directionality. ROI: CC, IC, PCB, TWM, UF, SLF. LS mean value was controlled for baseline value and visit.|Baseline, 6 Mos; Baseline, 12 Mos|All participants who enrolled in the study and had an evaluable MRI at the designated time point.||square meters per second (m²/sec) * 10¹⁰||95% Confidence Interval|Least Squares Mean
689251|NCT01459016|Primary|Change From Baseline in Diffusion Tensor Imaging (DTI) Using Fractional Anisotropy (FA)|DTI scans used FA to measure water diffusion directionality in selected white matter (WM) tracts. ROI: Corpus collosum (CC), internal capsule (IC), posterior cingulum bundle (PCB), temporal white matter (TWM), uncinate fasciculus (UF), superior longitudinal fasciculus (SLF). LS mean value was controlled for baseline value and visit.|Baseline, 6 Mos; Baseline, 12 Mos|All participants who enrolled in the study and had an evaluable MRI at the designated time point.||au||95% Confidence Interval|Least Squares Mean
689252|NCT01459016|Primary|Change From Baseline in Resting State Functional Magnetic Resonance Imaging (rsfMRI)|Distributed functional connectivity in selected brain networks was calculated from the rsfMRI scans. Values were derived from low-frequency (0.01-0.1 hertz [Hz]) temporal correlations between different regions over the approximately 6-minute rsfMRI time series scan. Distributed measures of functional connectivity were calculated as the mean Pearson correlation between the average low-frequency time courses in predefined sets of regions of interest (ROI) within the default mode network (DMN), salience network (SN) and sensorimotor networks (SMN). LS mean value was controlled for baseline value and visit.|Baseline, 6 Mos; Baseline, 12 Mos|All participants who enrolled in the study and had an evaluable MRI at the designated time point.||arbitrary units (au)||95% Confidence Interval|Least Squares Mean
689253|NCT01459016|Primary|Change From Baseline in Volumetric Magnetic Resonance Imaging (vMRI) - Hippocampus Volume Average Percent (%) Change (Chg)|Automated hippocampal volumetry was performed using the Learning Embeddings for Atlas Propagation (LEAP) algorithm. LS mean value was controlled for baseline value and visit.|Baseline, 6 Mos; Baseline, 12 Mos|All participants who enrolled in the study and had an evaluable MRI at the designated time point.||percentage of hippocampus volume average||95% Confidence Interval|Least Squares Mean
689254|NCT01459016|Primary|Change From Baseline in Volumetric Magnetic Resonance Imaging (vMRI) - Brain Boundary Shift Integral (BBSI) and Ventricular Boundary Shift Integral (VBSI)|BBSI and VBSI were calculated based on the voxel-wise difference between co-registered baseline and follow-up scans. Least squares (LS) mean value was controlled for baseline value and visit.|Baseline, 6 Mos; Baseline, 12 Mos|All participants who enrolled in the study and had an evaluable MRI at the designated time point.||milliliters (mL)||95% Confidence Interval|Least Squares Mean
689255|NCT01458951|Secondary|Change From Baseline in Total Mayo Score at Week 8|Change in total Mayo scores at Week 8 relative to Baseline was reported. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible centrally read proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher score indicating more severe disease.|Baseline, Week 8|Full analysis set included all participants who were randomly assigned to either tofacitinib 10 mg BID or placebo BID. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||units on a scale||Standard Deviation|Mean
689256|NCT01458951|Secondary|Change From Baseline in Partial Mayo Scores at Weeks 2, 4 and 8|Change in Partial Mayo scores at Weeks 2, 4, 8 relative to baseline were reported. A Partial Mayo Score (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and PGA) with each graded from 0 to 3 with higher scores indicating more severe disease.|Baseline, Weeks 2, 4, 8|Full analysis set included all participants who were randomly assigned to either tofacitinib 10 mg BID or placebo BID. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||units on a scale||Standard Error|Least Squares Mean
689257|NCT01458951|Secondary|Partial Mayo Scores|A partial mayo score (mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and PGA) and each grading from 0 to 3 with higher scores indicating more severe disease.|Baseline, Weeks 2, 4, 8|Full analysis set included all participants who were randomly assigned to either tofacitinib 10 mg BID or placebo BID. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||units on a scale||Standard Deviation|Mean
689258|NCT01458951|Secondary|Percentage of Participants With Deep Remission at Week 8|Deep remission in participants was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and 0 subscore for both rectal bleeding and endoscopic subscores. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible centrally read proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher score indicating more severe disease.|Week 8|Full analysis set included all participants who were randomly assigned to either tofacitinib 10 mg BID or placebo BID.||percentage of participants|||Number
689259|NCT01458951|Secondary|Percentage of Participants With Symptomatic Remission at Week 8|Symptomatic remission was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point, and 0 subscore for both rectal bleeding and stool frequency. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible centrally read proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher score indicating more severe disease.|Week 8|Full analysis set included all participants who were randomly assigned to either tofacitinib 10 mg BID or placebo BID.||percentage of participants|||Number
689286|NCT01458587|Secondary|Edema at Visit 5|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|12 Weeks after PDT #1|ITT||participants|||Number
717388|NCT00267644|Primary|Maximum IVC Diameter|Maximum Inferior Vena Cava diameter in mm|10 minutes|||mm||Full Range|Median
689260|NCT01458951|Secondary|Percentage of Participants With Clinical Remission at Week 8|Clinical remission in participants was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible centrally read proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher score indicating more severe disease.|Week 8|Full analysis set included all participants who were randomly assigned to either tofacitinib 10 mg BID or placebo BID.||percentage of participants|||Number
689261|NCT01458951|Secondary|Percentage of Participants With Endoscopic Remission at Week 8|Endoscopic remission in participants was defined by Mayo endoscopic subscore of 0. The Mayo endoscopic subscore consisted of the findings of centrally read flexible proctosigmoidoscopy, graded from 0 to 3 with higher scores indicating more severe disease.|Week 8|Full analysis set included all participants who were randomly assigned to either tofacitinib 10 mg BID or placebo BID.||percentage of participants|||Number
689262|NCT01458951|Secondary|Percentage of Participants Achieving Clinical Response at Week 8|Clinical response in participants was defined by a decrease from baseline in Mayo score of at least 3 points and at least 30 percent, with an accompanying decrease in the rectal bleeding sub score of at least 1 point or an absolute rectal bleeding sub score of 0 or 1. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible centrally read proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher score indicating more severe disease.|Week 8|Full analysis set included all participants who were randomly assigned to either tofacitinib 10 mg BID or placebo BID.||percentage of participants|||Number
689263|NCT01458951|Secondary|Percentage of Participants Achieving Mucosal Healing at Week 8|Mucosal healing in participants was defined by Mayo endoscopic subscore of 0 or 1. The Mayo endoscopic subscore consisted of the findings of centrally read flexible proctosigmoidoscopy, graded from 0 to 3 with higher scores indicating more severe disease.|Week 8|Full analysis set included all participants who were randomly assigned to either tofacitinib 10 mg BID or placebo BID.||percentage of participants|||Number
689264|NCT01458951|Primary|Percentage of Participants With Remission at Week 8|Remission in participants was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score is an instrument designed to measure disease activity of Ulcerative Colitis . It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and physician global assessment (PGA), each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher score indicating more severe disease.|Week 8|Full analysis set included all participants who were randomly assigned to either tofacitinib 10 mg BID or placebo BID.||percentage of participants|||Number
689265|NCT01458639|Secondary|Safety of Technegas in Patients With Possible PE|Safety will be assessed by the incidence of treatment emergence adverse events and changes in clinical laboratory measurements, blood pressure, oxygen saturation, physical examination and pulmonary examination before and after treatment.|Prospective, from enrollment through 30 days follow-up|All subjects who received Technegas and completed safety follow-up procedures.||participants|||Number
689266|NCT01458639|Secondary|Likelihood Ratio for Diagnosis of PE|Likelihood ratios of V/Q imaging for diagnosis of PE is determined by the results of blind-read assessment of images compared with truth using a subject's final clinical diagnosis following 30-day follow-up of occurence of PE or death, whichever occurs first.|Prospective, 30 days follow-up|PE adjudication for final clinical diagnosis was to be determined by an Independent Adjudication Committee and blinded readings of Xe-133 and Technegas Ventilation and Tc-99m MAA Perfusion images were required for primary and secondary outcome data. Due to trial termination PE adjudication and blinded readings of images were not done.|||||
689267|NCT01458639|Secondary|Negative Predictive Value (NPV) of Imaging for Diagnosis of PE|NPV of V/Q imaging for diagnosis of PE is determined by the results of blind-read assessment of images compared with truth using a subject's final clinical diagnosis following 30-day follow-up of occurence of PE or death, whichever occurs first.|Prospective, 30 days follow-up|PE adjudication for final clinical diagnosis was to be determined by an Independent Adjudication Committee and blinded readings of Xe-133 and Technegas Ventilation and Tc-99m MAA Perfusion images were required for primary and secondary outcome data. Due to trial termination PE adjudication and blinded readings of images were not done.|||||
689268|NCT01458639|Secondary|Positive Predictive Value (PPV) of Imaging for Diagnosis of PE|PPV of V/Q imaging for diagnosis of PE is determined by the results of blind-read assessment of images compared with truth using a subject's final clinical diagnosis following 30-day follow-up of occurence of PE or death, whichever occurs first.|Prospective, 30 days follow-up|PE adjudication for final clinical diagnosis was to be determined by an Independent Adjudication Committee and blinded readings of Xe-133 and Technegas Ventilation and Tc-99m MAA Perfusion images were required for primary and secondary outcome data. Due to trial termination PE adjudication and blinded readings of images were not done.|||||
689269|NCT01458639|Secondary|Accuracy of Technegas V/Q SPECT and Xenon V/Q Planar Imaging for Diagnosis of PE|Accuracy of V/Q imaging for diagnosis of PE is determined by the results of blind-read assessment of images compared with truth using a subject's final clinical diagnosis following 30-day follow-up of occurence of PE or death, whichever occurs first.|prospective, 30 days follow-up.|PE adjudication for final clinical diagnosis was to be determined by an Independent Adjudication Committee and blinded readings of Xe-133 and Technegas Ventilation and Tc-99m MAA Perfusion images were required for primary and secondary outcome data. Due to trial termination PE adjudication and blinded readings of images were not done.|||||
689270|NCT01458639|Primary|Specificity of Technegas V/Q SPECT for the Diagnosis of PE.|"Compared to the specificity of Xenon V/Q Planar imaging. Truth based on blinded reader's assessments of V/Q SPECT images compared with subject's final diagnosis resulting from clinical information at 30 days follow-up."|Prospective, 30 days follow-up|Pulmonary embolism adjudication was to be determined by an Independent Adjudication Committee for primary and secondary outcome data and blinded readings of Xe-133 and Technegas Ventilation and Tc-99m MAA Perfusion images were required for primary outcome data. Due to trial termination PE adjudication and blinded readings of images were not done.|||||
718029|NCT00285779|Secondary|Patient Assessment of Pain on a Visual Analogue Scale (VAS) at 12 and 24 Weeks||12 and 24 weeks||||||
689271|NCT01458639|Primary|Sensitivity of Technegas V/Q SPECT for the Diagnosis of PE|"Compared to the sensitivity of Xenon V/Q Planar imaging. Truth based on blinded reader's assessments of V/Q SPECT images compared with subject's final diagnosis resulting from clinical information at 30 days follow-up."|Prospective, 30 days follow-up|Pulmonary embolism adjudication was to be determined by an Independent Adjudication Committee for primary and secondary outcome data and blinded readings of Xe-133 and Technegas Ventilation and Tc-99m MAA Perfusion images were required for primary outcome data. Due to trial termination PE adjudication and blinded readings of images were not done.|||||
689272|NCT01458587|Secondary|OOZING/VESICULATION/CRUSTING at Visit 5|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|12 Weeks after PDT #1|ITT observed||participants|||Number
689273|NCT01458587|Secondary|OOZING/VESICULATION/CRUSTING at Visit 4|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|8 Weeks after PDT #1|ITT observed||participants|||Number
689274|NCT01458587|Secondary|OOZING/VESICULATION/CRUSTING at Visit 3|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|Week 2 after PDT #1|ITT observed||participants|||Number
689275|NCT01458587|Secondary|OOZING/VESICULATION/CRUSTING at Baseline|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|Baseline|ITT observed||participants|||Number
689276|NCT01458587|Secondary|Scaling and Dryness at Visit 5|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|12 Weeks Post PDT #1|ITT observed||participants|||Number
689277|NCT01458587|Secondary|Scaling and Dryness at Visit 4|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|8 Weeks Post PDT #1|ITT observed||participants|||Number
689278|NCT01458587|Secondary|Scaling and Dryness at Visit 3|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|2 Weeks Post PDT #1|ITT observed||participants|||Number
689279|NCT01458587|Secondary|Scaling and Dryness at Baseline|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Baseline|ITT observed||participants|||Number
689280|NCT01458587|Secondary|Stinging/Burning at Visit 5|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|12 Weeks after PDT #1|ITT, observed||participants|||Number
689281|NCT01458587|Secondary|Stinging/Burning at Visit 4|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|8 Weeks after PDT #1|ITT, observed||participants|||Number
689282|NCT01458587|Secondary|Stinging/Burning at Visit 3|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|2 Weeks after PDT #1|ITT, observed||participants|||Number
689283|NCT01458587|Secondary|Stinging/Burning Post Light Treatment|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|5 minutes after PDT #1|ITT, observed||participants|||Number
689284|NCT01458587|Secondary|Stinging/Burning During Light Treatment|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|During PDT #1|ITT, observed||participants|||Number
689285|NCT01458587|Secondary|Stinging/Burning at Baseline|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|Baseline|ITT, observed||participants|||Number
689287|NCT01458587|Secondary|Edema at Visit 4|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|8 Weeks after PDT #1|ITT||participants|||Number
689288|NCT01458587|Secondary|Edema at Visit 3|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|2 Weeks after PDT #1|ITT||participants|||Number
689289|NCT01458587|Secondary|Edema Post-Light Treatment|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|5 Minutes after PDT #1|ITT||participants|||Number
689290|NCT01458587|Secondary|Edema at Baseline|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Baseline|ITT||participants|||Number
689291|NCT01458587|Secondary|Erythema at Visit 5|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|12 Weeks after PDT #1|ITT||participants|||Number
689292|NCT01458587|Secondary|Erythema at Visit 4|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|8 Weeks after PDT #1|ITT||participants|||Number
689293|NCT01458587|Secondary|Erythema at Visit 3|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|2 Weeks after PDT #1|ITT||participants|||Number
689294|NCT01458587|Secondary|Erythema Post-Light Treatment|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|5 Minutes after PDT #1|ITT||participants|||Number
689295|NCT01458587|Secondary|Erythema at Baseline|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Baseline|ITT||participants|||Number
689296|NCT01458587|Secondary|Hypopigmentation at Visit 5|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation|12 Weeks after PDT #1|ITT||participants|||Number
689297|NCT01458587|Secondary|Hypopigmentation at Visit 4|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation|8 Weeks after PDT #1|ITT||participants|||Number
689298|NCT01458587|Secondary|Hypopigmentation at Visit 3|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation|2 Weeks after PDT #1|ITT||participants|||Number
689299|NCT01458587|Secondary|Hypopigmentation at Baseline|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation|Baseline|ITT||participants|||Number
689300|NCT01458587|Secondary|Hyperpigmentation at Visit 5|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|12 weeks after PDT #1|ITT||participants|||Number
690096|NCT01451541|Secondary|Percentage of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs||Weeks 0 -12|||percentage of subjects|||Number
689301|NCT01458587|Secondary|Hyperpigmentation at Visit 4|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|8 weeks after PDT #1|ITT||participants|||Number
689302|NCT01458587|Secondary|Hyperpigmentation at Visit 3|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|2 weeks after PDT #1|ITT||participants|||Number
689303|NCT01458587|Secondary|Hyperpigmentation at Baseline|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Baseline|ITT||participants|||Number
689304|NCT01458587|Secondary|Subject Satisfaction Score|"Subject satisfaction score
= Excellent (very satisfied)
= Good (moderately satisfied)
= Fair (slightly satisfied)
= Poor (not satisfied at all)"|Week 12|ITT||participants|Participants||Number
689305|NCT01458587|Secondary|Partial Clearance Rate|proportion of subjects with 75% or more reduction in the AK count in the Treatment Area as compared to baseline.|Baseline and Week 12|ITT LOCF||arms >75% cleared|Participants||Number
689306|NCT01458587|Secondary|Partial Clearance Rate|proportion of subjects with 75% or more reduction in the AK count in the Treatment Area as compared to baseline.|Baseline and Week 8|ITT LOCF||arms >75% cleared|Participants||Number
689307|NCT01458587|Secondary|Complete Clearance Rate|proportion of subjects with a count of zero lesions in the treatment area|Week 12|ITT LOCF||arms 100% cleared|Participants||Number
689308|NCT01458587|Secondary|Complete Clearance Rate|proportion of subjects with a count of zero lesions in the treatment area|Week 8|ITT LOCF||arms 100% cleared|Participants||Number
689309|NCT01458587|Secondary|Lesion Clearance Rate||Week 8|ITT LOCF||percentage of lesions cleared|Participants|Standard Deviation|Median
689310|NCT01458587|Primary|Lesion Clearance Rate|Clearance rate for all lesions|Week 12|ITT analysis with LOCF||percentage of lesions cleared|Participants|Standard Deviation|Median
689311|NCT01458574|Secondary|Percentage of Participants in Sustained Steroid-Free Remission, Among Participants Receiving Steroids at Baseline|Sustained steroid-free remission was defined by being in remission and steroid-free at both Week 24 and Week 52. Steroid-free remission was defined by being in remission, in addition to no requirement of any treatment with steroid for at least 4 weeks prior to the visit. Remission was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. Percentage of participants with sustained steroid-free remission were reported in this outcome measure.|Week 24, 52|"FAS included all randomized participants. Here number of participants analyzed signifies those participants who were evaluable for this outcome measure."||percentage of participants|||Number
689312|NCT01458574|Secondary|Percentage of Participants in Steroid-Free Remission, Among Participants Receiving Steroids at Baseline|Steroid-free remission was defined by being in remission, in addition to no requirement of any treatment with steroid for at least 4 weeks prior to the visit. Remission was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. Percentage of participants with steroid-free remission were reported in this outcome measure.|Week 24, 52|"FAS included all randomized participants. Here number of participants analyzed signifies those participants who were evaluable for this outcome measure."||percentage of participants|||Number
689313|NCT01458574|Secondary|Percentage of Participants in Steroid-free Remission, Among Participants in Remission at Baseline|Steroid-free remission was defined by being in remission, in addition to no requirement of any treatment with steroid for at least 4 weeks prior to the visit. Remission was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. Percentage of participants in steroid-free remission were reported in this outcome measure.|Week 24, 52|"FAS included all randomized participants. Here number of participants analyzed signifies those participants who were evaluable for this outcome measure."||percentage of participants|||Number
689314|NCT01458574|Secondary|Percentage of Participants in Sustained Remission, Among Participants With Remission at Baseline|Sustained remission in participants was defined by being in remission at both Week 24 and Week 52. Remission was defined as a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher score indicating higher disease severity.|Week 24, 52|"FAS included all randomized participants. Here number of participants analyzed signifies those participants who were evaluable for this outcome measure."||percentage of participants|||Number
689315|NCT01458574|Secondary|Percentage of Participants in Remission, Among Participants With Remission at Baseline|Remission in participants was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher score indicating higher disease severity.|Week 24, 52|"FAS included all randomized participants. Here number of participants analyzed signifies those participants who were evaluable for this outcome measure."||percentage of participants|||Number
689316|NCT01458574|Secondary|Change From Baseline in Total Mayo Score at Week 24 and 52|Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. Change from baseline in total mayo score at Week 24 and 52 was reported.|Baseline, Week 24, 52|FAS included all randomized participants. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||units on a scale||Standard Error|Least Squares Mean
689317|NCT01458574|Secondary|Total Mayo Score at Baseline, Week 24 and 52|Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.|Baseline, Week 24, 52|FAS included all randomized participants. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||units on a scale||Standard Deviation|Mean
689318|NCT01458574|Secondary|Percentage of Participants in Sustained Endoscopic Remission|Sustained endoscopic remission in participants was defined as being in endoscopic remission at both Week 24 and Week 52. Endoscopic remission was defined by a mayo endoscopic subscore of 0. The mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher subscores indicating higher disease severity.|Week 24, 52|FAS included all randomized participants.||percentage of participants|||Number
689319|NCT01458574|Secondary|Percentage of Participants in Endoscopic Remission at Week 24 and 52|Endoscopic remission in participants was defined as a mayo endoscopic subscore of 0. The mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher subscores indicating higher disease severity.|Week 24, 52|FAS included all randomized participants.||percentage of participants|||Number
689320|NCT01458574|Secondary|Percentage of Participants in Sustained Symptomatic Remission|Sustained symptomatic remission in participants was defined as being in symptomatic remission at both Week 24 and Week 52. Symptomatic remission was defined as a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point, and 0 subscore for both rectal bleeding and stool frequency. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.|Week 24, 52|FAS included all randomized participants.||percentage of participants|||Number
689321|NCT01458574|Secondary|Percentage of Participants in Symptomatic Remission at Week 24 and 52|Symptomatic remission in participants was defined as a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point, and 0 subscore for both rectal bleeding and stool frequency. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 sub-scores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.|Week 24, 52|FAS included all randomized participants.||percentage of participants|||Number
689322|NCT01458574|Secondary|Percentage of Participants in Sustained Deep Remission|Sustained deep remission was defined by being in deep remission at both Week 24 and Week 52. Deep remission in participants was defined as a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and 0 subscore for both rectal bleeding and endoscopic subscores. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.|Week 24, 52|FAS included all randomized participants.||percentage of participants|||Number
689323|NCT01458574|Secondary|Percentage of Participants in Deep Remission at Week 24 and 52|Deep remission in participants was defined as a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and 0 subscore for both rectal bleeding and endoscopic subscores. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.|Week 24, 52|FAS included all randomized participants.||percentage of participants|||Number
689324|NCT01458574|Secondary|Percentage of Participants in Sustained Clinical Remission|Sustained clinical remission in participants was defined as being in clinical remission at both Week 24 and Week 52. Clinical remission was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.|Week 24, 52|FAS included all randomized participants.||percentage of participants|||Number
690097|NCT01451541|Secondary|Number of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs||Weeks 0 -12|||participants|||Number
689325|NCT01458574|Secondary|Percentage of Participants in Clinical Remission at Week 24 and 52|Clinical remission in participants was defined as a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.|Week 24, 52|FAS included all randomized participants.||percentage of participants|||Number
689326|NCT01458574|Secondary|Percentage of Participants With Sustained Clinical Response|Sustained clinical response in participants was defined as showing clinical response at both Week 24 and Week 52. Clinical response was defined by a decrease from induction study (A3921094 [NCT01465763] or A3921095 [NCT01458951]) baseline in mayo score of at least 3 points and at least 30%, with an accompanying decrease in the rectal bleeding subscore of at least 1 point, or an absolute rectal bleeding subscore of 0 or 1. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. Percentage of participants with sustained clinical response are reported in this outcome measure.|Week 24, 52|FAS included all randomized participants.||percentage of participants|||Number
689327|NCT01458574|Secondary|Percentage of Participants With Clinical Response at Week 24 and 52|Clinical response was defined by a decrease from induction study (A3921094 [NCT01465763] or A3921095 [NCT01458951]) baseline in Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the rectal bleeding subscore of at least 1 point, or an absolute rectal bleeding subscore of 0 or 1. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. Percentage of participants with clinical response at Week 24 and 52 have been reported in this outcome measure.|Week 24, 52|FAS included all randomized participants.||percentage of participants|||Number
689328|NCT01458574|Secondary|Percentage of Participants With Sustained Mucosal Healing, Among Participants With Mucosal Healing at Baseline|Sustained mucosal healing in participants was defined by achieving mayo endoscopic subscore of 0 or 1 at both Week 24 and Week 52. The mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher scores indicating higher disease severity.|Week 24, 52|"FAS included all randomized participants. Here number of participants analyzed signifies those participants who were evaluable for this outcome measure."||percentage of participants|||Number
689329|NCT01458574|Secondary|Percentage of Participants With Mucosal Healing at Week 24 and 52, Among Participants With Mucosal Healing at Baseline|Mucosal healing in participants was defined as achieving mayo endoscopic subscore of 0 or 1. The mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher scores indicating higher disease severity.|Week 24, 52|"FAS included all randomized participants. Here number of participants analyzed signifies those participants who were evaluable for this outcome measure."||percentage of participants|||Number
689330|NCT01458574|Secondary|Percentage of Participants With Sustained Mucosal Healing|Sustained mucosal healing in participants was defined by achieving mayo endoscopic subscore of 0 or 1 at both Week 24 and Week 52. The mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher scores indicating higher disease severity.|Week 24, 52|FAS included all randomized participants.||percentage of participants|||Number
689331|NCT01458574|Secondary|Percentage of Participants With Mucosal Healing at Week 24|Mucosal healing in participants was defined by a mayo endoscopic subscore of 0 or 1. The mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher scores indicating higher disease severity.|Week 24|FAS included all randomized participants.||percentage of participants|||Number
689332|NCT01458574|Secondary|Percentage of Participants in Sustained Remission|Sustained remission in participants was defined by being in remission at both Week 24 and Week 52. Remission was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher subscores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher score indicating higher disease severity.|Week 24, 52|FAS included all randomized participants.||percentage of participants|||Number
689333|NCT01458574|Secondary|Percentage of Participants in Remission at Week 24|Remission in participants was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher subscores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.|Week 24|FAS included all randomized participants.||percentage of participants|||Number
689350|NCT01458561|Secondary|Intraoperative Blood Loss|Amount of blood lost between time of initial application of prescribed hemostatic agent and confirmed achievement of hemostasis (achievement of hemostasis eval. out to 10 minutes following application of prescribed hemostatic agent)|Time from initial application to confirmed achievement of hemostasis (eval. up to 10 minutes following application of hemostatic agent)|Study terminated before appropriate data collection/analysis|||||
689351|NCT01458561|Secondary|Achievement of Immediate Hemostasis|Number of subjects achieving hemostasis at 1 minute after application of prescribed hemostatic agent|1 minute after application of prescribed hemostatic agent|Study was terminated before any subjects were enrolled into the BioFoam arm||participants|||Number
690132|NCT01451411|Secondary|Time From the First Dose of Study Medication to a Confirmed ≥ 4 mEq/L Increase From Baseline in Serum Sodium||48 hours|Data from two subjects (one conivaptan, and one placebo) were censored as the serum sodium never achieved a value greater or equal to 4 mEq/L above the baseline value.||hours||Full Range|Mean
689334|NCT01458574|Secondary|Percentage of Participants With Sustained Steroid-Free Remission (Defined as Being in Remission and Steroid-Free at Both Week 24 and 52), Among Participants With Remission at Baseline|Sustained steroid-free remission was defined by being in remission and steroid-free at both Week 24 and Week 52. Steroid-free remission was defined by being in remission, in addition to no requirement of any treatment with steroid for at least 4 weeks prior to the visit. Remission was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. Percentage of participants with sustained steroid-free remission (among participants with remission at baseline) were reported in this outcome measure.|Week 24, 52|"FAS included all randomized participants. Here number of participants analyzed signifies those participants who were evaluable for this outcome measure."||percentage of participants|||Number
689335|NCT01458574|Secondary|Percentage of Participants With Mucosal Healing at Week 52|Mucosal healing in participants was defined by mayo endoscopic subscore of 0 or 1. The mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher subscores indicating higher disease severity.|Week 52|FAS included all randomized participants.||percentage of participants|||Number
689336|NCT01458574|Primary|Percentage of Participants In Remission at Week 52|Remission in participants was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of ulcerative colitis (UC). It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and physician global assessment (PGA), each subscore graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12 where higher score indicating higher disease severity.|Week 52|FAS included all randomized participants.||percentage of participants|||Number
689337|NCT01458561|Secondary|Number of Procedure Complications and/or Adverse Events||Through final follow-up (2 years postoperatively)|||Number of complications and AEs|||Number
689338|NCT01458561|Secondary|Evaluation of Anti-Bovine Serum Albumin (Anti-BSA) Antibody Titers|Evaluation of anti-BSA antibody titers to determine number of subjects/participants with a positive titer at various time points|Preoperatively (up to 30 days before surgery), immediately post-application of hemostatic agent (within minutes), within 48 hrs postoperatively, up to 48 hrs before hospital discharge, at 7-10 days, 30 days, 3 mos, 6 mos, 9 mos, 1 yr, and 2 yr postop|Blood samples were to be analyzed in batches to more accurately assess for any changes over time; the study was terminated before the first batch was analyzed, so no data is available for anti-BSA titer testing.|||||
689339|NCT01458561|Secondary|Subjects Requiring Additional Hospitalization/Surgical Intervention|Number of subjects requiring additional hospitalization/surgical intervention following final wound closure through the 2 year follow-up|Any hospitalization/surgical intervention following final wound closure through 2 year follow-up visit (average 2 yr duration)|Study terminated before any subjects were enrolled into the BioFoam arm||# of participants|||Number
689340|NCT01458561|Secondary|Total Hospitalization Time|Length of time between hospital admission (day of surgery) and hospital discharge (average 5-7 days)|Hospital admission (day of surgery) until hospital discharge (average 5-7 days)|Study terminated before any subjects were enrolled into the BioFoam arm||days|||Number
689341|NCT01458561|Secondary|Core Body Temperature||At the time of test or control article application (expected average 3-4 hours from skin cut)|Study terminated before any subjects were enrolled into the BioFoam arm||degrees Celcius|||Number
689342|NCT01458561|Secondary|Total Time of Operative Procedure||Skin cut to skin closure (average 4-5 hour duration)|Study terminated before any subjects were enrolled into the BioFoam arm||minutes|||Number
689343|NCT01458561|Secondary|Number of Subjects Requiring Reoperation Due to Bleeding and/or Biliary Leakage (Reoperation Required? y/n)|Number of subjects requiring reoperation due to bleeding and/or biliary leakage out to 2 years postoperatively (reoperation required? y/n)|After final wound closure through 2 year follow-up visit (average 2 yr duration)|Study terminated before any subjects were enrolled into the BioFoam arm||number of participants|||Number
689344|NCT01458561|Secondary|Eval. for Presence of Device by MRI w/ & w/Out Contrast, & Diagnose/Eval. Abdominal Fluid Collection/Biliary Leak, Residual Scarring, Hepatic Regeneration, & Assess for Emergence of Primary/Recurrent Malignancy by MRI w/ or w/Out Contrast as Appropriate||Within 48 hours postoperatively, up to 48 hours prior to hospital discharge (avg. 5-7 days postoperatively), and 30 days, 3 months, 6 months, 9 months, 1 year, and 2 years postoperatively|||participants|||Number
689345|NCT01458561|Secondary|Subject Laboratory Evaluations|Number of laboratory evaluations outside of range from preoperative assessments through final 2 year follow-up|Preoperatively through final 2 year follow-up|Study terminated before any subjects were enrolled into the BioFoam arm||Number of participants with labs in rang|||Number
689346|NCT01458561|Secondary|Amount of Intraoperative Blood Products Administered|Amount of blood products administered intraoperatively (throughout procedure: from initial skin cut to final wound closure)|Intraoperatively (throughout procedure, from initial skin cut to final wound closure, average 4-5 hours duration)|Study terminated before any subjects were enrolled into the BioFoam arm||units of blood product(s)|||Number
689347|NCT01458561|Secondary|Duration of Drainage|Total length of time between drain insertion and last recorded emptying time during hospitalization (where applicable), average 24-72 hours postoperatively|Time between drain insertion and last recorded emptying time during hospitalization (where applicable), average 24-72 hours postoperatively|Study terminated before any subjects were enrolled into the BioFoam arm||hours|||Number
689348|NCT01458561|Secondary|Amount of Postoperative Fluid Loss|Amount of fluid lost postoperatively [measured between time of drain insertion (if applicable) to drain removal, average 24-72 hours postoperatively]|Time from drain insertion to drain removal (where applicable), average 24-72 hours postoperatively|Study terminated before any subjects were enrolled into the BioFoam arm||milliliters (mL)|||Number
689349|NCT01458561|Secondary|Amount of Postoperative Bilious Drainage||Time from drain insertion to drain removal (where applicable), average 24-72 hours postoperatively|Study terminated before any subjects were enrolled into the BioFoam arm||milliliters (mL)|||Number
689352|NCT01458561|Secondary|Time to Hemostasis|"Number of subjects achieving hemostasis [by assessing for hemostasis (yes/no)] at pre-determined time points: 1, 3, 5, 7, and 10 minutes following application of prescribed hemostatic agent. Time to hemostasis is recorded as the first of the predetermined time points to receive a yes assessment."|1, 3, 5, 7, and 10 minutes following application of prescribed hemostatic agent|Study terminated before any subjects were enrolled into the BioFoam arm||minutes|||Number
689353|NCT01458561|Primary|Time to Achieve Intraoperative Hemostasis Following Open Liver Resection Surgery in Subjects Receiving an Application of BioFoam or a Standard Topical Hemostatic Agent|Number of subjects achieving intraoperative hemostasis (y/n) at 3 minutes following a single application of the prescribed hemostatic agent|3 minutes following a single application of the prescribed hemostatic agent|Study was terminated before any subjects were enrolled into the BioFoam arm||participants|||Number
689354|NCT01458535|Secondary|Percentage of Participants Who Experienced Virologic Relapse Through End of Post Treatment Period (up to 48 Weeks)|Virologic relapse is defined as confirmed hepatitis C virus (HCV) ribonucleic acid (RNA) >= lower limit of quantitation (LLOQ) (2 consecutive measurements >= LLOQ) at any point in the post-treatment period among participants with HCV RNA < LLOQ at the end of treatment. Participants with missing data were imputed as failures.|Post-treatment Day 1 to Post-treatment Week 48|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT) with hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantitation (LLOQ) at the final treatment visit who completed treatment.||percentage of participants|||Number
689355|NCT01458535|Secondary|Percentage of Participants With Virologic Failure During Treatment|Virologic failure during treatment is defined as a participant meeting any virologic stopping criteria, including 1) rebound (defined as the first day of 2 consecutive increases of at least 0.5 log10 IU/mL above nadir (local minimum value), or first day of 2 consecutive HCV RNA >= LLOQ for participants who previously achieved HCV RNA < LLOQ) during treatment, 2) participant who fails to suppress (defined as never achieving HCV RNA < LLOQ during treatment).|Day 1 through Week 12|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).||percentage of participants|||Number
689356|NCT01458535|Secondary|Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Below the Lower Limit of Quantitation (LLOQ) at Week 4 Rapid Virologic Response (RVR)|Analysis of percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (< 25 IU/mL). Participants with missing data were imputed as failures.|Week 4|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).||percentage of participants|||Number
689357|NCT01458535|Secondary|Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) < 1000 International Units Per Milliliter (IU/mL)|Analysis of participants with HCV RNA levels below 1000 IU/mL at Week 2. Participants with missing data were imputed as failures.|Week 2|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).||percentage of participants|||Number
689358|NCT01458535|Secondary|Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) Post-Treatment|Sustained Virologic Response 24 (SVR24) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ; < 25 IU/mL) 24 weeks after the last dose of study drug. Participants with missing data were imputed as failures.|Post-treatment Day 1 to Post-treatment Week 24|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).||percentage of participants|||Number
689359|NCT01458535|Secondary|Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment|Sustained Virologic Response 12 (SVR12) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (< LLOQ; < 25 IU/mL) 12 weeks after the last dose of study drug. Participants with missing data were imputed as failures.|Post-treatment Day 1 to Post-treatment Week 12|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).||percentage of participants|||Number
689360|NCT01458535|Primary|Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Suppressed Below the Lower Limit of Quantitation (LLOQ) From Week 4 Through Week 12 [(Extended Rapid Virologic Response (eRVR)]|Analysis of the percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (< 25 IU/mL). Participants with missing data were imputed as failures.|Week 4 through Week 12|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).||percentage of participants|||Number
689361|NCT01458392|Secondary|Disease Control Rate|Disease control rate will be estimated as the proportion of patients evaluable for response who meet the criteria for complete response, partial response, or stable disease.|Tumor assessments performed every 6 weeks, up to 30 days after the last dose of dalantercept and/or disease progression, up to approximately 2 years.|The two patients at the 80 mg, fixed-dose level were excluded from the efficacy analysis as the protocol had been amended to incorporate weight-based dosing for the remainder of the study population. 40 received at least one dose of study drug in either the 0.6 mg/kg or 1.2 mg/kg dose groups and had at least one on-treatment tumor assessment.||percentage of participants||95% Confidence Interval|Number
689362|NCT01458392|Secondary|Overall Survival (OS)|OS is calculated as the number of months from date of the first dose to the date of death. The last patient treated will be followed for overall survival for 1 year following treatment initiation.|Survival captured until death or at a minimum 1 year from first dose of dalantercept.|The two patients at the 80 mg, fixed-dose level were excluded from the efficacy analysis as the protocol had been amended to incorporate weight-based dosing for the remainder of the study population.||weeks||95% Confidence Interval|Median
689363|NCT01458392|Secondary|Progression Free Survival (PFS)|PFS is defined as the date of the first dose to the first observation of disease progression (according to RECIST v.1.1) or death due to any cause. Progression is defined using RECIST v1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Tumor assessments performed every 6 weeks, up to 30 days after the last dose of dalantercept and/or disease progression, up to approximately 2 years.|The two patients at the 80 mg, fixed-dose level were excluded from the efficacy analysis as the protocol had been amended to incorporate weight-based dosing for the remainder of the study population.||weeks||95% Confidence Interval|Median
690133|NCT01451411|Primary|Mean Change From Baseline to the End of the 48-hour Treatment Period in Serum Sodium||baseline and 48 hours|||mEq/L||Standard Deviation|Mean
718030|NCT00285779|Secondary|The Individual and Total Cutaneous Target Lesion Scores at 12 and 24 Weeks||12 weeks and 24 weeks||||||
689364|NCT01458392|Secondary|Dalantercept Serum Concentration After Single and Multiple Doses|Pharmacokinetic samples were collected pre- and post- dose on Days: 1, 8, 15, 22, 29, and 43. Reported below is Cmax (cycle 1).|Up to 43 days from initiation of treatment.|The two patients at the 80 mg, fixed-dose level were excluded from the efficacy analysis as the protocol was amended to incorporate weight-based dosing for the remainder of the study population. 2 patients in the 0.6-mg/kg and 6 in the 1.2-mg/kg cohort had less than 2 measurable serum dalantercept concentrations and were excluded from PK analysis.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
689365|NCT01458392|Secondary|Dalantercept Serum Concentration After Single and Multiple Doses|Pharmacokinetic samples were collected pre- and post- dose on Days: 1, 8, 15, 22, 29, and 43. Reported below is AUC0-t (cycle 1).|Up to 43 days from initiation of treatment.|The two patients at the 80 mg, fixed-dose level were excluded from the efficacy analysis as the protocol was amended to incorporate weight-based dosing for the remainder of the study population. 2 patients in the 0.6-mg/kg and 6 in the 1.2-mg/kg cohort had less than 2 measurable serum dalantercept concentrations and were excluded from PK analysis.||ng*day/mL||Geometric Coefficient of Variation|Geometric Mean
689366|NCT01458392|Secondary|Safety and Tolerability|Number of participants with at least one adverse event as a measure of safety and tolerability.|Adverse events captured from first dose of dalantercept through 30 days after last dose of dalantercept.|||participants|||Number
689367|NCT01458392|Primary|Objective Response Rate (ORR)|ORR is defined as the proportion of patients who met criteria for complete response or partial response. Patients were evaluable for ORR if they had at least one measurable lesion at baseline and at least one disease assessment after baseline. RECIST version 1.1 was used to evaluate efficacy. In addition, patients who developed clinical or radiological progression of disease prior to the scheduled tumor assessment were also considered evaluable for response. The response rate was estimated as the proportion of patients evaluable for response who meet the criteria for complete (CR) and partial response (PR). Per RECIST v1.1 for target lesions and assessed by MRI: complete response (CR), disappearance of all target lesions; partial response (PR), >=30% decrease in the sum of the longest diameter of target lesions; overall response (OR) = CR + PR.|Tumor assessments performed every 6 weeks, up to 30 days after the last dose of dalantercept and/or disease progression, up to approximately 2 years.|The two patients at the 80 mg, fixed-dose level were excluded from the efficacy analysis as the protocol had been amended to incorporate weight-based dosing for the remainder of the study population. 40 received at least one dose of study drug in either the 0.6 mg/kg or 1.2 mg/kg dose groups and had at least one on-treatment tumor assessment.||participants||95% Confidence Interval|Number
689368|NCT01458288|Secondary|the Pharmacodynamics (PD) of TG-0054|To evaluate the pharmacodynamics (PD) of TG-0054 by determining circulating CD34+ cell counts in peripheral blood.|pre-dose(-2 to 0 h),2, 4 and 6 hr after dosing.||||||
689369|NCT01458288|Secondary|the Safety of TG-0054 in Patients With MM, NHL or HD|To evaluate the safety of TG-0054 in patients with MM, NHL or HD All adverse events will be coded according to the MedDRA dictionary, and be limited to events related or not related to study drug.|1 month||||||
689370|NCT01458288|Secondary|the Average Number of Leukapheresis Sessions|To determine the average number of leukapheresis sessions required to collect 2.5 x106 CD34+ cells/kg.|1 week||||||
689371|NCT01458288|Primary|Number of Patients Achieving the CD34+ Hematopoietic Stem Cell (HSC) Mobilization Target of ≧2.5×1000000 Cells/kg|"Patients were all with multiple myeloma (MM), Non-Hodgkin lymphoma (NHL) or Hodgkin disease (HD).
Number of patients who mobilized the targeted total number of CD34+ cells within a maximum of 4 leukapheresis sessions in study arm 1 and arm 3. Patients in arm 1 followed administration of TG-0054 (3.14 mg/kg) alone and leukapheresis start from study day 1. Patients in arm 3 followed administration of TG-0054 (3.14 mg/kg) combined with granulocyte colony-stimulating factor (G-CSF) and leukapheresis start from study day 8."|1 week|||participants|||Number
689372|NCT01458275|Secondary|Percentage of Subjects Experiencing Treatment-emergent Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation||Weeks 0 - 3|||Percentage of participants|||Number
689373|NCT01458275|Secondary|Number of Subjects Experiencing Treatment-emergent Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation||Weeks 0 - 3|||participants|||Number
689374|NCT01458275|Secondary|Treatment-emergent AEs Causing Study Medication Discontinuation||Weeks 0 - 3|||participants|||Number
689375|NCT01458275|Secondary|Percentage of Subjects Experiencing Treatment-emergent AEs|Treatment-Emergent Adverse Events Occurring in ≥ 2% of Subjects in Any Treatment Group (ITT Population)|Weeks 0 - 3|||Percentage of participants|||Number
689376|NCT01458275|Secondary|Number of Subjects Experiencing Treatment-emergent AEs|Treatment-Emergent Adverse Events Occurring in ≥ 2% of Subjects in Any Treatment Group (ITT Population)|Weeks 0 - 3|||participants|||Number
689377|NCT01458275|Secondary|Time to Maximal Effect in the AM and PM Reflective Total Nasal Symptom Scores (rTNSS) Over the 2-week Double-blind Treatment Period|The time to maximal effect, defined as the number of days until the first treatment day on which the estimated difference between ciclesonide nasal aerosol and placebo was at least 90% of the largest estimated difference, was based on the analyses of change from baseline in the average of AM and PM rTNSS scores for each day. The time to achieve at least 90% of these estimated differences is presented.|Weeks 0 - 2|||Days|||Number
689378|NCT01458275|Secondary|Change From Baseline in Average Daily Subject-reported AM and PM Instantaneous Total Ocular Symptom Scores (iTOSS) Over the 2-week Double-blind Treatment Period.|"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TOSS symptom scores assess symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement"|Weeks 0 - 2|n = number of ITT subjects in treatment group with completed assessment||units on a scale||Standard Error|Least Squares Mean
689405|NCT01458171|Secondary|Percentage of Infusions With Subject-assessed Tolerability of at Least 'Good'|"Subjects assessed their overall perception of local tolerability at the infusion site throughout the study in the subject diary within a time window of 24 h to 72 h after the end of the latest infusion by assessing it as “very good”, “good”, “fair”, or “poor”. The reported percentage represents the percentage of subjects with local tolerability assessments of very good or good at any given study infusion."|24 to 72 hours after infusion|The FAS comprised all subjects receiving at least 1 IgPro20 infusion.||percentage of infusions|||Number
689379|NCT01458275|Secondary|Change From Baseline in Average Daily Subject Reported AM Instantaneous Total Nasal Symptom Scores (iTNSS) Over the 2-week Double-blind Treatment Period|TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions assessed in the AM. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1 = mild 2 = moderate 3 = severe in the AM. Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.|Weeks 0 - 2|n = number of ITT subjects in treatment group with completed assessment||units on a scale||Standard Error|Least Squares Mean
689380|NCT01458275|Secondary|Change From Baseline in the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Overall Score at the End of the Double-blind Treatment Period.|PRQLQ was developed to measure the functional problems (physical, emotional, and social) that are most troublesome to children with rhinoconjunctivitis. The PRQLQ has 23 questions in 5 domains (nose symptoms, eye symptoms, practical problems, activity limitation, and other symptoms). Children recalled how they were during the previous week and responded to each question on a 7-point scale (0 = not bothered to 6 = extremely bothered or 0 = none of the time to 6 = all of the time) for a total possible score of 138. The overall PRQLQ score is the mean of all 23 responses and the individual domain scores are the means of the items in those domains.|Weeks 0 - 2|n = number of ITT subjects in treatment group with completed assessment||units on a scale||Standard Error|Least Squares Mean
689381|NCT01458275|Secondary|Change From Baseline in Average Daily Subject-reported AM and PM Reflective Total Ocular Symptom Scores (rTOSS) Over the 2-week Double-blind Treatment Period.|"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TOSS symptom scores assess symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0 - 2|n = number of ITT subjects in treatment group with completed assessment||units on a scale||Standard Error|Least Squares Mean
689382|NCT01458275|Secondary|Change From Baseline in Average Daily Subject-reported AM and PM Instantaneous Total Nasal Symptom Scores (iTNSS) Over the 2-week Double-blind Treatment Period|TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1 = mild 2 = moderate 3 = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.|Weeks 0 - 2|n = number of ITT subjects in treatment group with completed assessment||units on a scale||Standard Error|Least Squares Mean
689383|NCT01458275|Primary|Change From Baseline in Average Daily Subject Reported AM and PM Reflective Total Nasal Symptom Scores (rTNSS) Over the 2-week Double-blind Treatment Period|TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1 = mild 2 = moderate 3 = severe. Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.|Weeks 0 - 2|n = number of ITT subjects in treatmentgroup with completed assessment||units on a scale||Standard Error|Least Squares Mean
689384|NCT01458249|Secondary|Best Overall Response (BOR)|The best overall response categories (CR, PR, SD [including non-CR/non-PD], PD, not evaluable [NE], and unknown [UNK]) were derived based on time point tumor responses during the study as assessed by the IRC as well as the investigator. Tumor assessment was performed at Week 6 and Week 12 after the start of study treatment, and every six weeks thereafter. BOR of SD must have occurred at least 35 days (at least 5 weeks) after the first dose of study drug. If a participant had a BOR of non-CR/non-PD, the participant's BOR was grouped with the SD category.|Date of CR, PR, SD to PD or death of any cause, whichever is first, or date of study cutoff (14 Nov 2014), or up to 3 years|Full analysis set included all participants who received at least one dose of study drug. This was the primary analysis set for all efficacy evaluations. Arm 1 included all participants with ADI or LMS. Arm 2 included all participants with soft tissue sarcomas other than ADI or LMS (OTH).||Percentage of participants|||Number
689385|NCT01458249|Secondary|Durable Stable Disease (SD) Rate (dSDR)|Durable stable disease rate was defined as the percentage of participants who manifested durable stable disease (the duration of stable disease for greater than or equal to eleven weeks) and was estimated based on the tumor response assessments performed according to RECIST v1.1. Tumor assessment was performed at Week 6 and Week 12 after the start of study treatment, and every six weeks thereafter. A 2-sided 95% CI was calculated using the exact method of binomial distribution.|Date of dSD to date of PD or death, whichever is first, or date of study cutoff (24 Nov 2014), up to 3 years|Full analysis set included all participants who received at least one dose of study drug. This was the primary analysis set for all efficacy evaluations. Arm 1 included all participants with ADI or LMS. Arm 2 included all participants with soft tissue sarcomas other than ADI or LMS (OTH).||Percentage of participants||95% Confidence Interval|Number
689406|NCT01458171|Secondary|Number of Subjects With Newly Developing or Worsening AEs|Number of subjects with AEs, overall and classified (i) by severity (mild, moderate, severe) and (ii) by causal relationship to study medication (not related or unlikely related; at least possibly related [i.e., possibly related, probably related, or related]).|24 weeks|The AT set comprised all subjects receiving at least 1 IgPro20 infusion.||participants|||Number
689477|NCT01457950|Secondary|Median Percent Change From Baseline in s-CTX and s-P1NP Biomarkers at Months 1, 3 and 6|Serum carboxy-terminal cross-linking telopeptide of type I collagen (s-CTx) I and Serum procollagen type I N propeptide s (s-PINP) are used as serum biomarkers of bone resorption in the assessment of osteoporosis and is measured in units of micrograms (µg)/liters (L). Percentage change from Baseline=(measure at post-Baseline – measure at Baseline) divided by measure at Baseline * 100.|Baseline, Months 1, 3 and 6|ITTE Population. Only participants at the specified time points were analyzed.||Percent change||Inter-Quartile Range|Median
689386|NCT01458249|Secondary|Clinical Benefit Rate (CBR)|CBR was defined as the percentage of participants who had a BOR of CR + PR + dSD (duration of SD greater than or equal to 11 weeks [77 days] after the first dose of study treatment). Tumor assessment was performed at Week 6 and Week 12 after the start of study treatment, and every six weeks thereafter. For participants whose BOR was SD, the duration of SD was defined as the time from the date of the first dose of study treatment to the first documented PD or death, whichever occurred first (i.e., same definition of PFS). If the dSD was censored at a time less than 11 weeks, the participant was considered as not having a clinical benefit. A 95% CI was calculated using exact method of binomial distribution.|First dose of study treatment to the date of CR, PR, or dSD to date of PD or death, whichever is first, or date of study cutoff (14 Nov 2014), up to 3 years|Full analysis set included all participants who received at least one dose of study drug. This was the primary analysis set for all efficacy evaluations. Arm 1 included all participants with ADI or LMS. Arm 2 included all participants with soft tissue sarcomas other than ADI or LMS (OTH).||Percentage of participants||95% Confidence Interval|Number
689387|NCT01458249|Secondary|Disease Control Rate (DCR)|Disease control rate was defined as the percentage of participants who had BOR of CR + PR + SD. BOR of SD must have manifested at least five weeks (35 days) after the first dose of study treatment. Tumor assessment was performed at Week 6 and Week 12 after the start of treatment, and every six weeks thereafter. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of the longest diameter since the treatment started. A 95% CI was calculated using exact method of binomial distribution.|Date of CR, PR, or SD to date of PD or death, whichever is first, or date of study cutoff (14 Nov 2014), up to 3 years|Full analysis set included all participants who received at least one dose of study drug. This was the primary analysis set for all efficacy evaluations. Arm 1 included all participants with ADI or LMS. Arm 2 included all participants with soft tissue sarcomas other than ADI or LMS (OTH).||Percentage of participants||95% Confidence Interval|Number
689388|NCT01458249|Secondary|Objective Response Rate (ORR)|Objective response rate was defined as the percentage of participants who had a best overall rate (BOR) of CR or PR. Tumor assessment was performed at Week 6 and Week 12 after the start of study treatment, and every six weeks thereafter. The BOR of CR and PR in this study required confirmation by a subsequent assessment of response at least four weeks (28 days) later. CR and PR were determined by the Investigator and IRC using RECIST v1.1 for target lesions assessed by MRI/CT scans. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. A 95% CI was calculated using exact method of binomial distribution.|Date of CR or PR to the date of PD or death, whichever is first, or date of study cutoff (14 Nov 2014), up to 3 years|Full analysis set included all participants who received at least one dose of study drug. This was the primary analysis set for all efficacy evaluations. Arm 1 included all participants with ADI or LMS. Arm 2 included all participants with soft tissue sarcomas other than ADI or LMS (OTH).||Percentage of participants||95% Confidence Interval|Number
689389|NCT01458249|Secondary|Overall Survival (OS)|Overall survival was defined as the time from the date of treatment start to the date of death from any cause. Participants were followed for survival every twelve weeks after PD. In the absence of confirmation of death, participants were censored either at the date that the participant was last known alive or the date of study cutoff, whichever came earlier. Participants censored before database cutoff included those who were lost to follow up and who withdrew consent. A 95% CI was calculated using Kaplan-Meier estimate and Greenwood Formula. A generalized Brookmeyer and Crowley method is used to construct a log-log-transformed 95% CI.|Cycle 1 (Day 1) to death, or date of study cutoff, (14 Nov 2014), up to 3 years|Full analysis set included all participants who received at least one dose of study drug. This was the primary analysis set for all efficacy evaluations. Arm 1 included all participants with ADI or LMS. Arm 2 included all participants with soft tissue sarcomas other than ADI or LMS (OTH).||Months||95% Confidence Interval|Median
689390|NCT01458249|Secondary|Progression-Free Survival (PFS)|Progression-free survival was defined as the time from the date of treatment start to the first documented date of event (disease progression or death from any cause, whichever occurred first). PFS was assessed every six weeks (until disease progression was confirmed, or sooner, if clinically indicated) and was based on Investigator and Independent Review Committee (IRC) assessments according to RECIST v1.1. Disease progression was measured using computed tomography (CT) or magnetic resonance imaging (MRI) on targeted tumors and defined as at least a 20% relative increase and 5 mm absolute increase in the sum of diameters of target lesions (taking as reference the smallest sum on study), recorded since the treatment started or the appearance of 1 or more new lesions. A 95% CI was calculated using Kaplan-Meier estimate and Greenwood Formula. A generalized Brookmeyer and Crowley method was used to construct a log-log-transformed 95% CI.|Cycle 1 (Day 1) to progressive disease (PD) or death, or date of study cutoff (14 Nov 2014) up to 3 years|Full analysis set included all participants who received at least one dose of study drug. This was the primary analysis set for all efficacy evaluations. Arm 1 included all participants with ADI or LMS. Arm 2 included all participants with soft tissue sarcomas other than ADI or LMS (OTH).||Months||95% Confidence Interval|Median
689407|NCT01458171|Secondary|Overall Rate of AEs Per Infusion|The rate was calculated by counting all newly developed or worsened AEs during the treatment period in all subjects and dividing the total number of AEs by the total number of IgPro20 infusions administered. In addition, individual AEs were classified (i) by severity (mild, moderate, severe) and (ii) by causal relationship to study medication (not related or unlikely related; at least possibly related [i.e., possibly related, probably related, or related]). The AE rates per infusion by severity and causal relationship to study medication were calculated by dividing the number of AEs in each category by the total number of IgPro20 infusions.|24 weeks|The AT set comprised all subjects receiving at least 1 IgPro20 infusion.||AEs per infusion|Participants||Number
689494|NCT01457521|Primary|11-point Visual Analog Scale for Pain|Participant pain was assessed using an 11-point Visual Analog Scale for Pain. Scores ranged from 0 (no pain) to 10 (worst pain possible)|1-2 weeks|||units on a scale||Standard Deviation|Mean
720325|NCT00291551|Primary|Death or Additional Surgical Session at 6 Months||6 months|Per protocol||participants|||Number
689391|NCT01458249|Primary|Progression-free Rate at 12 Weeks (PFR12wks)|The PFR at 12 weeks was the percentage of participants with progression-free survival (success) measured as a binary variable based on the tumor response assessed at Week 12 after the start of study treatment. Participants were considered a success if one radiological evaluation performed at least Week 12 after start of therapy indicated stable disease (SD), or complete response (CR) or partial response (PR), as defined according to Response Evaluation Criteria in Solid Tumor version 1.1 (RECIST v1.1); all other cases were considered as failures (including disease progression or death before the Week 12 evaluation, or had unknown disease status at Week 12). If new anticancer treatments were started before the Week 12 evaluation, participants were considered failures. A 2-sided 90% confidence interval (CI) was calculated using the exact method of binomial distribution.|Week 12|Full analysis set included all participants who received at least one dose of study drug. This was the primary analysis set for all efficacy evaluations. Arm 1 included all participants with ADI or LMS. Arm 2 included all participants with soft tissue sarcomas other than ADI or LMS (OTH).||Percentage of participants||90% Confidence Interval|Number
689392|NCT01458210|Primary|Pharmacokinetics: Time of Maximum Observed Drug Concentration (Tmax) of Ortho-Cyclen – Ethinyl Estradiol (EE)||Day 21 during Periods 1 and 2: Pre-dose and up to 24 hours post-dose|Participants who received at least 1 dose of study drug with evaluable ethinyl estradiol (EE) concentration data.||hours||Full Range|Median
689393|NCT01458210|Primary|Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of Ortho-Cyclen – Ethinyl Estradiol (EE)||Day 21 during Periods 1 and 2: Pre-dose and up to 24 hours post-dose|Participants who received at least 1 dose of study drug with evaluable ethinyl estradiol (EE) concentration data.||picograms per milliliter (pg/mL)||Geometric Coefficient of Variation|Geometric Mean
689394|NCT01458210|Primary|Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) at Steady State of Ortho-Cyclen - Ethinyl Estradiol (EE)||Day 21 during Periods 1 and 2: Pre-dose and up to 24 hours post-dose|Participants who received at least 1 dose of study drug with evaluable ethinyl estradiol (EE) concentration data.||picograms*hour/milliliter (pg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
689395|NCT01458210|Primary|Pharmacokinetics: Time of Maximum Observed Drug Concentration (Tmax) of Ortho-Cyclen - Norelgestromin (NGMN)||Day 21 Periods 1 and 2: Pre-dose and up to 24 hours post-dose|Participants who received at least 1 dose of study drug with evaluable norelgestromin (NGMN) concentration data.||hours||Full Range|Median
689396|NCT01458210|Primary|Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of Ortho-Cyclen - Norelgestromin (NGMN)||Day 21 during Periods 1 and 2: Pre-dose and up to 24 hours post-dose|Participants who received at least 1 dose of study drug with evaluable norelgestromin (NGMN) concentration data.||picograms per milliliter (pg/mL)||Geometric Coefficient of Variation|Geometric Mean
689397|NCT01458210|Primary|Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) at Steady State of Ortho-Cyclen - Norelgestromin (NGMN)||Day 21 during Periods 1 and 2: Pre-dose and up to 24 hours post-dose|Participants who received at least 1 dose of study drug with evaluable norelgestromin (NGMN) concentration data.||picograms*hour/milliliter (pg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
689398|NCT01458171|Other Pre-specified|Rate of Infection Episodes (Serious and Non-serious)|The annualized rate of infection episodes (serious and non-serious) was based on the total number of infection episodes and the total number of subject study days for all subjects in the FAS population and the PPS population and adjusted to 365 days.|24 weeks|The FAS comprised all subjects receiving at least 1 IgPro20 infusion. The PPS comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.||infection episodes per subject year|Participants||Number
689399|NCT01458171|Secondary|Duration of Use of Antibiotics for Infection Prophylaxis and Treatment|Median number of days of use of antibiotics for infection prophylaxis and/or treatment|24 weeks|The FAS comprised all subjects receiving at least 1 IgPro20 infusion. The PPS comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.||days||Full Range|Median
689400|NCT01458171|Secondary|Number of Days of Hospitalization Due to Infections.|Median number of days of hospitalization due to infections.|24 weeks|The FAS comprised all subjects receiving at least 1 IgPro20 infusion. The PPS comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.||days||Full Range|Median
689401|NCT01458171|Secondary|Number of Days Out of Work/School/Kindergarten/Day Care or Unable to Perform Normal Daily Activities Due to Infections.|Median number of days out of work/school/kindergarten/day care or unable to perform normal daily activities due to infections.|24 weeks|The FAS comprised all subjects receiving at least 1 IgPro20 infusion. The PPS comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.||days||Full Range|Median
689402|NCT01458171|Secondary|Number of Infection Episodes (Serious and Non-serious)||24 weeks|The FAS comprised all subjects receiving at least 1 IgPro20 infusion. The PPS comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.||infection episodes|||Number
689403|NCT01458171|Secondary|Annualized Rate of Clinically Documented Serious Bacterial Infections (SBIs)|SBIs are defined as bacterial pneumonia, bacteremia and septicemia, osteomyelitis/septic arthritis, bacterial meningitis, or visceral abscess. The annualized rate was based on the total number of SBIs and the total number of subject study days for all subjects in the FAS and PPS and adjusted to 365 days.|24 weeks|The FAS comprised all subjects receiving at least 1 IgPro20 infusion. The PPS comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.||SBIs per subject year|Participants||Number
689404|NCT01458171|Secondary|IgG Trough Level|Serum IgG trough levels at the completion visit compared to the baseline visit of the follow-up study. IgG trough levels at baseline, at the completion visit, and the change from baseline to the completion visit are shown|24 weeks|The Full Analysis Set (FAS) comprised all subjects receiving at least 1 IgPro20 infusion. The Per Protocol Set (PPS) comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.||g/L||Standard Deviation|Mean
689408|NCT01458171|Primary|Median of the Individual Subject's Rate of Adverse Events (AEs) Per Infusion|The rate was calculated by counting all newly developed or worsened AEs within a subject and dividing by the total number of IgPro20 infusions administered to this subject. Subsequently, the median of these individual AE rates per infusion was calculated. AE rates were classified (i) by severity (mild, moderate, severe) and (ii) by causal relationship to study medication (not related or unlikely related; at least possibly related [i.e., possibly related, probably related, or related]).|24 weeks|The All Treated (AT) set comprised all subjects receiving at least 1 IgPro20 infusion.||AEs per infusion||Full Range|Median
689409|NCT01458106|Secondary|Percentage of AUCinf Extrapolated From the Last Data Point to Infinity (%AUCext; Two-stage Chromogenic Assay)|Percentage of AUCinf extrapolated from the last data point to infinity for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.||percentage of AUCinf||95% Confidence Interval|Geometric Mean
689410|NCT01458106|Secondary|Percentage of AUCinf Extrapolated From the Last Data Point to Infinity (%AUCext; One-stage aPTT Clotting Assay)|Percentage of AUCinf extrapolated from the last data point to infinity for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.||percentage of AUCinf||95% Confidence Interval|Geometric Mean
689411|NCT01458106|Secondary|Area Under the Curve to Infinity (AUCinf; Two-stage Chromogenic Assay)|Dose normalized area under the FVIII activity-time curve to infinity for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.||IU*h/dL||95% Confidence Interval|Geometric Mean
689412|NCT01458106|Secondary|Area Under the Curve to Infinity (AUCinf; One-stage aPTT Clotting Assay)|Dose normalized area under the FVIII activity-time curve to infinity for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.||IU*h/dL||95% Confidence Interval|Geometric Mean
689413|NCT01458106|Secondary|Area Under the Curve to the Last Measurable Timepoint (AUClast; Two-stage Chromogenic Assay)|Dose-normalized area under the FVIII activity-time curve to the last measurable timepoint for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.||IU*h/dL||95% Confidence Interval|Geometric Mean
689414|NCT01458106|Secondary|Area Under the Curve to the Last Measurable Timepoint (AUClast; One-stage aPTT Clotting Assay)|Dose-normalized area under the FVIII activity-time curve to the last measurable timepoint for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.||IU*h/dL||95% Confidence Interval|Geometric Mean
689415|NCT01458106|Secondary|Volume at Terminal Phase (Vz; Two-stage Chromogenic Assay)|Volume of distribution estimated from the terminal phase for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.||mL/kg||95% Confidence Interval|Geometric Mean
689447|NCT01457950|Other Pre-specified|Change From Baseline in Red Blood Cell Count at Month 12|Change from Baseline was calculated as the Month 12 value minus the Baseline value.|Baseline and Month 12|ITT-OL Population: Ony those participants with a value at Baseline and Month 12 were analyzed.||10^12 cells per liter (TI/L)||Standard Deviation|Mean
689416|NCT01458106|Secondary|Volume at Terminal Phase (Vz; One-stage aPTT Clotting Assay)|Volume of distribution estimated from the terminal phase for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.||mL/kg||95% Confidence Interval|Geometric Mean
689417|NCT01458106|Secondary|Lambda Z (Two-stage Chromogenic Assay)|First order rate constant associated with the terminal portion of the curve (lambda z) for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.||1/hours||95% Confidence Interval|Geometric Mean
689418|NCT01458106|Secondary|Lambda Z (One-stage aPTT Clotting Assay)|First order rate constant associated with the terminal portion of the curve (lambda z) for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.||1/hours||95% Confidence Interval|Geometric Mean
689419|NCT01458106|Secondary|Time at Maximum Activity (Tmax; Two-stage Chromogenic Assay)|Time at which maximum activity (Cmax) is observed for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.||hours||95% Confidence Interval|Geometric Mean
689420|NCT01458106|Secondary|Time at Maximum Activity (Tmax; One-stage aPTT Clotting Assay)|Time at which maximum activity (Cmax) is observed for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.||hours||95% Confidence Interval|Geometric Mean
689421|NCT01458106|Secondary|Incremental Recovery (IR; Two-stage Chromogenic Assay)|The rise in FVIII activity in IU/dL per unit dose administered in IU/kg for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.||IU/dL per IU/kg||95% Confidence Interval|Geometric Mean
689422|NCT01458106|Secondary|Incremental Recovery (IR; One-stage aPTT Clotting Assay)|The rise in FVIII activity in IU/dL per unit dose administered in IU/kg for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.||IU/dL per IU/kg||95% Confidence Interval|Geometric Mean
689423|NCT01458106|Secondary|Mean Residence Time (MRT; Two-stage Chromogenic Assay)|The average time that a drug molecule is present in the systemic circulation for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.||hours||95% Confidence Interval|Geometric Mean
689448|NCT01457950|Other Pre-specified|Change From Baseline in Mean Corpuscle Hemoglobin at Month 12|Change from Baseline was calculated as the Month 12 value minus the Baseline value.|Baseline and Month 12|ITT-OL Population: Ony those participants with a value at Baseline and Month 12 were analyzed.||Picograms (PG)/cell)||Standard Deviation|Mean
720976|NCT00317044|Secondary|Number of Patients With Severe Asthma Exacerbations.||Up to 6 months|||Participants|||Number
689424|NCT01458106|Secondary|Mean Residence Time (MRT; One-stage aPTT Clotting Assay)|The average time that a drug molecule is present in the systemic circulation for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.||hours||95% Confidence Interval|Geometric Mean
689425|NCT01458106|Secondary|Dose Normalized Area Under the Curve (DNAUC; Two-stage Chromogenic Assay)|Dose normalized area under the FVIII activity-time curve for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.||IU*h/dL per IU/kg||95% Confidence Interval|Geometric Mean
689426|NCT01458106|Secondary|Dose Normalized Area Under the Curve (DNAUC; One-stage aPTT Clotting Assay)|Dose normalized area under the FVIII activity-time curve for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.||IU*h/dL per IU/kg||95% Confidence Interval|Geometric Mean
689427|NCT01458106|Secondary|Volume at Steady State (Vss; Two-stage Chromogenic Assay)|Volume of distribution at steady state for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.||mL/kg||95% Confidence Interval|Geometric Mean
689428|NCT01458106|Secondary|Volume at Steady State (Vss; One-stage aPTT Clotting Assay)|Volume of distribution at steady state for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.||mL/kg||95% Confidence Interval|Geometric Mean
689429|NCT01458106|Secondary|Clearance (CL; Two-stage Chromogenic Assay)|Rate at which the body removes the drug, measured as the volume of the plasma cleared of drug per unit time per unit weight for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.||mL/h/kg||95% Confidence Interval|Geometric Mean
689430|NCT01458106|Secondary|Clearance (CL; One-stage aPTT Clotting Assay)|Rate at which the body removes the drug, measured as the volume of the plasma cleared of drug per unit time per unit weight for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.||mL/h/kg||95% Confidence Interval|Geometric Mean
689431|NCT01458106|Secondary|Elimination Half Life (t1/2; Two-stage Chromogenic Assay)|Time required for the activity of the drug to reach half of its original value for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.||hours||95% Confidence Interval|Geometric Mean
689449|NCT01457950|Other Pre-specified|Change From Baseline in Hematocrit at Month 12|Change from Baseline was calculated as the Month 12 value minus the Baseline value.|Baseline and Month 12|ITT-OL Population: Ony those participants with a value at Baseline and Month 12 were analyzed.||Proportion of RBCs in blood||Standard Deviation|Mean
689432|NCT01458106|Secondary|Elimination Half Life (t1/2; One-stage aPTT Clotting Assay)|Time required for the activity of the drug to reach half of its original value for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.||hours||95% Confidence Interval|Geometric Mean
689433|NCT01458106|Secondary|Maximum Plasma Activity (Cmax; Two-stage Chromogenic Assay)|Maximum plasma activity during a dosing interval for participants in the PK subgroup. The values for Cmax were adjusted to the nominal dose of 50 IU/kg. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.||IU/dL||95% Confidence Interval|Geometric Mean
689434|NCT01458106|Secondary|Maximum Plasma Activity (Cmax; One-stage Activated Partial Thromboplastin Time [aPTT] Clotting Assay)|Maximum plasma activity during a dosing interval for participants in the PK subgroup. The values for Cmax were adjusted to the nominal dose of 50 IU/kg. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.||IU/dL||95% Confidence Interval|Geometric Mean
689435|NCT01458106|Secondary|Total Dose Required for Resolution of a Bleeding Episode|The total dose required to resolve a bleeding episode per participant and per episode, based on the efficacy period. The efficacy period begins with the first prophylactic dose of rFVIIIFc and ends with the last dose (for prophylaxis or a bleed). Surgery/rehabilitation periods and PK evaluation periods are not included in the efficacy period. For 'Per bleeding episode' values, for each bleeding episode, the total dose is the sum of the doses (IU/kg) administered across all injections given to treat that bleeding episode. For 'Per participant' values, the total dose (IU/kg) used to resolve each bleed is averaged across all bleeding episodes per participant.|Up to Week 26 +/- 7 days (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc; number of participants and number of episodes were determined for participants who had complete information on the dose administered to treat a bleeding episode.||IU/kg|Bleeding Episodes|Full Range|Median
689436|NCT01458106|Secondary|Number of Injections Required for Resolution of a Bleeding Episode|The number of injections required to resolve a bleeding episode per participant and per episode, based on the efficacy period. The efficacy period begins with the first prophylactic dose of rFVIIIFc and ends with the last dose (for prophylaxis or a bleed). Surgery/rehabilitation periods and PK evaluation periods are not included in the efficacy period. All injections given from the initial sign of a bleed, until the last date/time within the bleed window are counted. The resolution of a bleed is defined as no sign of bleeding following injection for the bleed. For 'Per participant' values, the number of injections required to resolve each bleed is averaged across all bleeding episodes per participant.|Up to Week 26 +/- 7 days (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc; number of participants and number of episodes were determined for participants with at least 1 evaluable bleeding episode.||injections|Bleeding Episodes|Inter-Quartile Range|Median
689437|NCT01458106|Secondary|Number of Days From Last Treatment Injection to a Spontaneous Bleeding Episode|The number of days from the last prophylaxis injection to the onset of a new spontaneous bleeding episode, analyzed across all evaluable bleeding episodes per participant and per episode, based on the efficacy period. Evaluable bleeding episodes are those for which both a date and time are available for both the onset of the bleeding episode and the previous prophylactic injection. The efficacy period begins with the first prophylactic dose of rFVIIIFc and ends with the last dose (for prophylaxis or a bleed). Surgery/rehabilitation periods and PK evaluation periods are not included in the efficacy period. For 'Per participant' values, the number of days from the last prophylactic injection to a spontaneous bleeding episode is averaged across all evaluable spontaneous bleeding episodes per participant.|Up to Week 26 +/- 7 days (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc; number of participants and number of episodes were determined for participants with at least 1 evaluable spontaneous bleeding episode.||days|Evaluable Spontaneous Bleeding Episodes|Inter-Quartile Range|Median
689438|NCT01458106|Secondary|Annualized rFVIIIFc Consumption Per Participant|Consumption is calculated for the efficacy period. The efficacy period begins with the first prophylactic dose of rFVIIIFc and ends with the last dose (for prophylaxis or a bleed). Surgery/rehabilitation periods and PK evaluation periods are not included in the efficacy period. Annualized consumption = (total IU/kg of study treatment received during the efficacy period / total number of days during the efficacy period)*365.25. Consumption was calculated overall for all participants and for the last 3 months (91 days) on study, counted backwards from the end of the efficacy period, for participants with at least 24 weeks on study.|Up to Week 26 +/- 7 days (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc. 'Overall' n=participants in the Full Analysis Set with evaluable data in the efficacy period; 'Last 3 Months on Study' n=participants in the Full Analysis Set with evaluable data and ≥ 24 weeks on study.||IU/kg rFVIIIFc per participant per year||Standard Deviation|Mean
689495|NCT01457430|Secondary|Percent Change in VAS Scores|Baseline, 4 hours VAS scale ranges from 0-100 with 0 being the lowest severity and 100 being the highest severity|Percent Change in VAS Score from Baseline to 4 Hours|||percent change||Inter-Quartile Range|Median
689439|NCT01458106|Secondary|Physician’s Global Assessment of the Participant’s Response to His rFVIIIFc Regimen|Investigators assessed each participant’s response to his rFVIIIFc regimen using a 4-point scale: excellent=bleeding episodes responded to ≤ the usual number of injections or ≤ the usual dose of rFVIIIFc or the rate of breakthrough bleeding during prophylaxis was ≤ that usually observed; effective=most bleeding episodes responded to the same number of injections and dose, but some required more injections or higher doses, or there was a minor increase in the rate of breakthrough bleeding; partially effective=bleeding episodes most often required more injections and/or higher doses than expected, or adequate breakthrough bleeding prevention during prophylaxis required more frequent injections and/or higher doses; ineffective=routine failure to control hemostasis, or hemostatic control required additional agents. Percentages are based on the total number of responses; multiple responses per participant are counted.|Up to Week 26 +/- 7 days|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc; based on the number of responses.||percentage of responses|Responses||Number
689440|NCT01458106|Secondary|Participant Assessment of Response to Injections to Treat a Bleeding Episode|Participant's assessment (provided by the caregiver) of the response to the first rFVIIIFc injection for each bleeding episode. Percentages were based on the number of first injections for which a response was provided, using the following 4-point scale: excellent=abrupt pain relief and/or improvement in signs of bleeding within approximately 8 hours after the initial injection; good=definite pain relief and/or improvement in signs of bleeding within approximately 8 hours after a single injection, but possibly requiring more than one injection after 24 to 48 hours for complete resolution; moderate=probable or slight beneficial effect within approximately 8 hours after the initial injection and requiring more than one injection; no response=no improvement, or condition worsened, within approximately 8 hours after the initial injection.|Up to Week 26 +/- 7 days|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc and had a bleeding episode; participants with a non-evaluable bleed are counted in the number of participants analyzed, but not the percentages.||percent of 1st injections w/ a response|Injections||Number
689441|NCT01458106|Secondary|Annualized Joint Bleeding Rate (Spontaneous)|Annualized bleeding rate for spontaneous joint bleed=(number of bleeding episodes meeting those criteria during the efficacy period/total number of days during the efficacy period)*365.25. The efficacy period begins with the first prophylactic dose of rFVIIIFc and ends with the last dose (for prophylaxis or a bleed). Surgery/rehabilitation periods and PK evaluation periods are not included in the efficacy period. A bleeding episode started from the first sign of a bleed and ended no more than 72 hours after the last treatment for the bleed, within which any symptoms of bleeding at the same location or injections less than or equal to 72 hours apart were considered the same bleeding episode. Any injection to treat the bleeding episode taken more than 72 hours after the preceding one was considered the first injection to treat a new bleeding episode at the same location. Any bleeding at a different location was considered a separate bleeding episode, regardless of time from last inject|Up to Week 26 +/- 7 days (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc; based on the number of participants whose efficacy period is of at least 1 day in duration.||bleeding episodes per participant per yr||Inter-Quartile Range|Median
689442|NCT01458106|Secondary|Annualized Bleeding Rate|Annualized bleeding rate = (number of bleeding episodes during the efficacy period / total number of days during the efficacy period)*365.25. The efficacy period begins with the first prophylactic dose of rFVIIIFc and ends with the last dose (for prophylaxis or a bleed). Surgery/rehabilitation periods and PK evaluation periods are not included in the efficacy period. A bleeding episode started from the first sign of a bleed and ended no more than 72 hours after the last treatment for the bleed, within which any symptoms of bleeding at the same location or injections less than or equal to 72 hours apart were considered the same bleeding episode. Any injection to treat the bleeding episode taken more than 72 hours after the preceding one was considered the first injection to treat a new bleeding episode at the same location. Any bleeding at a different location was considered a separate bleeding episode, regardless of time from last injection.|Up to Week 26 +/- 7 days (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc; based on the number of participants whose efficacy period was of at least 1 day in duration.||bleeding episodes per participant per yr||Inter-Quartile Range|Median
689443|NCT01458106|Primary|Occurrence of FVIII Inhibitor Development|An inhibitor test result ≥0.6 Bethesda units (BU)/mL, confirmed on 2 separate samples drawn 2 to 4 weeks apart, was considered positive. Both tests were to be performed by the central laboratory using the Nijmegen-modified Bethesda Assay. Incidences were summarized for any positive inhibitor for participants with ≥50 EDs to rFVIIIFc. In addition, the incidence for all participants, regardless of their EDs to rFVIIIFc, was also summarized. An exact 95% CI for the proportion of participants with a confirmed inhibitor was calculated using the Clopper-Pearson exact method for a binomial proportion.|Up to Week 26 +/- 7 days, or up to 50 exposure days (EDs) if reached prior to Week 26|Safety Analysis Set: participants who received at least 1 dose of prestudy FVIII, or at least 1 dose of rFVIIIFc; n=number of participants with given number of exposure days who had a valid inhibitor test.||percentage of participants||95% Confidence Interval|Number
689444|NCT01457950|Other Pre-specified|Number of Participants With Positive and Negative Results for Anti-body Formation to Denosumab at Month 12|Number of participants with positive and negative results for both neutralizing antibodies to denosumab, and for binding antibodies to denosumab at Month 12 was summarized.|Month 12|ITT-OL Population: Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT-OL population.||Participants|||Number
689445|NCT01457950|Other Pre-specified|Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Month 12|Vital Sign Changes from Baseline of potential clinical concern for Diastolic Blood Pressure (<50 or >120 Bits Per Minutes [bpm]), Systolic Blood Pressure (>170 Millimeters of Mercury [mmHg] or <100 mmHg) and Heart rate (>110 mmHg or <50 mmHg) are summarized. Change from Baseline was calculated as the Month 12 value minus the Baseline value.|Baseline and Month 12|ITT-OL Population: Ony those participants with a value at Baseline and Month 12 were analyzed.||Participants|||Number
689446|NCT01457950|Other Pre-specified|Change From Baseline in Red Cell Distribution Width at Month 12|Change from Baseline was calculated as the Month 12 value minus the Baseline value.|Baseline and Month 12|ITT-OL Population: Ony those participants with a value at Baseline and Month 12 were analyzed.||percentage (%) of mean RBC volume||Standard Deviation|Mean
689450|NCT01457950|Other Pre-specified|Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 12|Change from Baseline was calculated as the Month 12 value minus the Baseline value.|Baseline and Month 12|ITT-OL Population: Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT-OL population.||Millimole/Liter (MMOL/L)||Standard Deviation|Mean
689451|NCT01457950|Other Pre-specified|Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine and Uric Acid at Month 12|Change from Baseline was calculated as the Month 12 value minus the Baseline value.|Baseline and Month 12|ITT-OL Population: Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT-OL population.||Micromole/liter (UMOL/L)||Standard Deviation|Mean
689452|NCT01457950|Other Pre-specified|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 12|Change from Baseline was calculated as the Month 12 value minus the Baseline value.|Baseline and Month 12|ITT-OL Population: Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT-OL population.||10^9 cells per liter (GI/L)||Standard Deviation|Mean
689453|NCT01457950|Other Pre-specified|Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at Month 12|Change from Baseline was calculated as the Month 12 value minus the Baseline value.|Baseline and Month 12|ITT-OL Population: Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT-OL population.||Internationational Units(IU)/Liter (L)||Standard Deviation|Mean
689454|NCT01457950|Other Pre-specified|Change From Baseline in Albumin, Hemoglobin, Mean Corpuscle Hemoglobin and Total Protein at Month 12|Change from Baseline was calculated as the Month 12 value minus the Baseline value.|Baseline and Month 12|ITT-OL Population: Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT-OL population.||Grams (G)/Liter (L)||Standard Deviation|Mean
689455|NCT01457950|Other Pre-specified|Change From Baseline in Albumin/Globulin Ratio and Blood Urea Nitrogen (BUN)/Creatinine Ratio at Month 12|Change from Baseline was calculated as the Month 12 value minus the Baseline value.|Baseline and Month 12|ITT-OL Population: Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT-OL population.||Ratio||Standard Deviation|Mean
689456|NCT01457950|Other Pre-specified|Number of Participants With Any Adverse Events (AE) or Any Serious Adverse Events (SAE) During the Open-Label Extension Phase|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.|From Month 6 to Month 12|ITT-OL Population||Participants|||Number
689457|NCT01457950|Other Pre-specified|Median Percent Change From Month 6 in s-CTX and s-P1NP Biomarkers at Month 12 for Participants Previously Randomized to Placebo|Serum carboxy-terminal cross-linking telopeptide of type I collagen (s-CTx) I and Serum procollagen type I N propeptide s (s-PINP) are used as serum biomarkers of bone resorption in the assessment of osteoporosis and is measured in units of micrograms (µg)/liters (L). Percentage change from Month 6=(measure at Month 12 – measure at Month 6) divided by measure at Month 6 * 100.|Month 6 and Month 12|ITT-OL Population. Ony those participants with a value at Month 6 and Month 12 were analyzed.||Percent change||Inter-Quartile Range|Median
689458|NCT01457950|Other Pre-specified|Median Percent Change From Baseline in s-CTX and s-P1NP Biomarkers at Month 12 for Participants Previously Randomized to Denosumab|Serum carboxy-terminal cross-linking telopeptide of type I collagen (s-CTx) I and Serum procollagen type I N propeptide s (s-PINP) are used as serum biomarkers of bone resorption in the assessment of osteoporosis and is measured in units of micrograms (µg)/liters (L). Percentage change from Baseline=(measure at post-Baseline – measure at Baseline) divided by measure at Baseline * 100.|Baseline and Month 12|ITT-OL Population. Ony those participants with a value at Baseline and Month 12 were analyzed.||Percent change||Inter-Quartile Range|Median
689459|NCT01457950|Other Pre-specified|Mean Percent Change From Month 6 in Total Hip, Femoral Neck, and Trochanter BMD at Month 12 for Participants Previously Randomized to Placebo|Mean percent change from Month 6 in total hip, femoral neck, and trochanter bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using Analysis of Covariance (ANCOVA) model adjusting for treatment and Month 6 BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Month 6=(measure at Month 12 – measure at Month 6) divided by the measure at Month 6 * 100.|Month 6 and Month 12|ITT-OL Population. Ony those participants with a value at Month 6 and Month 12 were analyzed.||Percent change||Standard Error|Mean
689460|NCT01457950|Other Pre-specified|Mean Percent Change From Baseline in Total Hip, Femoral Neck, and Trochanter BMD at Month 12 for Participants Previously Randomized to Denosumab|Mean percent change from Baseline in total hip, femoral neck, and trochanter bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using Analysis of Covariance (ANCOVA) model adjusting for treatment and Baseline BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Baseline=(measure at Month 12 – measure at Baseline) divided by the measure at Baseline * 100.|Baseline and Month 12|ITT-OL Population. Ony those participants with a value at Baseline and Month 12 were analyzed.||Percent change||Standard Error|Mean
689461|NCT01457950|Other Pre-specified|Mean Percent Change From Month 6 in Lumbar Spine BMD at Month 12 for Participants Previously Randomized to Placebo|Mean percent change from Month 6 in lumbar spine bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using Analysis of Covariance (ANCOVA) model adjusting for treatment and Month 6 BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Month 6=(measure at Month 12 – measure at Month 6) divided by the measure at Month 6 * 100.|Month 6 and Month 12|ITT-OL Population. Ony those participants with a value at Month 6 and Month 12 were analyzed.||Percent change||Standard Error|Mean
689462|NCT01457950|Other Pre-specified|Mean Percent Change From Baseline in Lumbar Spine BMD at Month 12 for Participants Previously Randomized to Denosumab|Mean percent change from Baseline in lumbar spine bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using Analysis of Covariance (ANCOVA) model adjusting for treatment and Baseline BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Baseline=(measure at Month 12 – measure at Baseline) divided by the measure at Baseline * 100.|Baseline and Month 12|Intent-to-Treat Open-Label (ITT-OL) Population: all participants from the ITT population in the Double-Blind Phase who continued into the Open-Label Extension Phase of the study and received denosumab at Month 6. Ony those participants with a value at Baseline and Month 12 were analyzed.||Percent change||Standard Error|Mean
689463|NCT01457950|Secondary|Number of Participants With Positive and Negative Results for Anti-body Formation to Denosumab|Number of participants with positive and negative results for both neutralizing antibodies to denosumab, and for binding antibodies to denosumab at Month 6 was summarized.|Month 6|ITT Population. Only participants at the specified time points were analyzed.||Participants|||Number
689464|NCT01457950|Secondary|Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Month 6|Vital Sign Changes from Baseline of potential clinical concern for Diastolic Blood Pressure (<50 or >120 Bits Per Minutes [bpm]), Systolic Blood Pressure (>170 Millimeters of Mercury [mmHg] or <100 mmHg) and Heart rate (>110 mmHg or <50 mmHg) are summarized. Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants at the specified time points were analyzed.||Participants|||Number
689465|NCT01457950|Secondary|Change From Baseline in Red Cell Distribution Width at Month 6|Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants at the specified time points were analyzed.||percentage (%) of mean RBC volume||Standard Deviation|Mean
689466|NCT01457950|Secondary|Change From Baseline in Red Blood Cell Count at Month 6|Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants at the specified time points were analyzed.||10^12 cells per liter (TI/L)||Standard Deviation|Mean
689467|NCT01457950|Secondary|Change From Baseline in Mean Corpuscular Volume at Month 6|Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants at the specified time points were analyzed.||Femtoliters (FL)||Standard Deviation|Mean
689468|NCT01457950|Secondary|Change From Baseline in Mean Corpuscle Hemoglobin at Month 6|Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants at the specified time points were analyzed.||Picograms (PG)/cell||Standard Deviation|Mean
689469|NCT01457950|Secondary|Change From Baseline in Hematocrit at Month 6|Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants at the specified time points were analyzed.||Proportion of RBCs in blood||Standard Deviation|Mean
689470|NCT01457950|Secondary|Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 6|Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants at the specified time points were analyzed.||Millimole/Liter (MMOL/L)||Standard Deviation|Mean
689471|NCT01457950|Secondary|Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine and Uric Acid at Month 6|Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants at the specified time points were analyzed.||Micromole/liter (UMOL/L)||Standard Deviation|Mean
689472|NCT01457950|Secondary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 6|Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants at the specified time points were analyzed.||10^9 cells per liter (GI/L)||Standard Deviation|Mean
689473|NCT01457950|Secondary|Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at Month 6|Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants at the specified time points were analyzed. .||Internationational Units(IU)/Liter (L)||Standard Deviation|Mean
689474|NCT01457950|Secondary|Change From Baseline in Albumin, Hemoglobin, Mean Corpuscle Hemoglobin and Total Protein at Month 6|Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants at the specified time points were analyzed.||Grams (G)/Liter (L)||Standard Deviation|Mean
689475|NCT01457950|Secondary|Change From Baseline in Albumin/Globulin Ratio and Blood Urea Nitrogen (BUN)/Creatinine Ratio at Month 6|Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants at the specified time points were analyzed.||Ratio||Standard Deviation|Mean
689476|NCT01457950|Secondary|Number of Participants With Any Adverse Events (AE) or Any Serious Adverse Events (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.|From Baseline up to Month 6|Intent-to-Treat (ITT) Population: all participants who received one dose of study medication.||Participants|||Number
689478|NCT01457950|Secondary|Mean Percent Change From Baseline in Total Hip, Femoral Neck, and Trochanter BMD at Month 1 and Month 6|Mean percent change from Baseline in total hip, femoral neck, and trochanter bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using Analysis of Covarience (ANCOVA) model adjusting for treatment and Baseline BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Baseline=(measure at Month 1/6 – measure at Baseline) divided by the measure at Baseline * 100.|Baseline, Month 1 and Month 6|ITTE Population||Percent change||Standard Error|Mean
689479|NCT01457950|Secondary|Mean Percent Change From Baseline in Lumbar Spine BMD at Month 1|Mean percent change from Baseline in lumbar spine bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using Analysis of Covariance (ANCOVA) model adjusting for treatment and Baseline BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Baseline=(measure at Month 1 – measure at Baseline) divided by the measure at Baseline * 100.|Baseline and Month 1|ITTE Population||Percent change||Standard Error|Mean
689480|NCT01457950|Primary|Mean Percent Change From Baseline in Lumbar Spine BMD at Month 6|Mean percent change from Baseline in lumbar spine bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using the Analysis of Covariance (ANCOVA) model adjusting for treatment and Baseline BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Baseline=(measure at Month 6 – measure at Baseline) divided by the measure at Baseline * 100.|Baseline and Month 6|Intent-to-Treat Efficacy (ITTE) Population: all participants who received one dose of study medication, and had a Baseline measure and at least one post-Baseline efficacy measure during the Double-Blind Treatment Phase.||Percent change||Standard Error|Mean
689481|NCT01457885|Secondary|Incidence of Relapse||2 years|75 patients were enrolled. One patient was not treated. 3 patients were pediatric and therefore left off of this analysis.||percentage of patients||95% Confidence Interval|Number
689482|NCT01457885|Secondary|The Percentage of Patients Alive at 1 Year|Overall survival was calculated following transplant using a CloBu4 conditioning regimen for patients with non-remission AML|1 year|75 patients were enrolled. Only 74 patients were treated. 3 of the 74 patients were pediatric and were therefore left off of analysis.||percentage of patients||95% Confidence Interval|Number
689483|NCT01457885|Primary|Cumulative Incidence of Non Relapse Mortality (NRM)|Percentage of patients passed without relapse/recurrence at 1 year.|1 year|75 patients were enrolled. Only 74 patients were treated. 3 of the 74 patients were pediatric and were therefore left off of analysis.||percentage of patients||95% Confidence Interval|Number
689484|NCT01457846|Secondary|Percentage of Patients Without Progressive Disease at 8 Weeks|PD = A ≥ 20% increase in the sum of diameters of target lesions and an absolute increase of ≥ 5mm, taking as reference the smallest sum of diameters since treatment started including the baseline sum of diamters|Week 8 (±1 week)|Full analysis set - all treated patients||Percentage of patients|||Number
689485|NCT01457846|Secondary|Percentage Change From Baseline at Week 8 in Target Lesion Size|A negative change denotes a reduction in target lesion size. Percentage change from baseline in tumour size at 8 weeks in target lesion size.|Baseline, Week 8 (±1 week)|Full analysis set - all treated patients with at least one post baseline RECIST target lesion assessment scan||Percentage change||Standard Deviation|Mean
689486|NCT01457846|Secondary|Objective Response Rate|ORR=Percentage of patients with at least one visit response of CR (complete response) or PR (partial response) that is confirmed at least 4 weeks later; CR:disappearance of target lesions and no new lesions; PR is at least 30% decrease in sum of diameters of lesions taking as a reference the smallest sum since treatment started.|Week 8 (±1 week) and then every 8 weeks (±1 week)|The analysis included factors for treatment and FGFR2 FISH score (4/5 versus 6) and is based on the Full analysis set (all treated patients).||Patients (%)|||Number
689487|NCT01457846|Secondary|Overall Survival : Number of Patients Who Had Died at DCO (Data Cut Off)||Tumour size assessed at week 8 (±1 week) and then every 8 weeks (±1 week)|This secondary analysis included factors for treatment and FGFR2 FISH score (4/5 versus 6) and is based on the Full analysis set (all treated patients).||Patients|||Number
689488|NCT01457846|Primary|Median Progression Free Survival|PFS is the time from randomisation until the date of objective disease progression as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) or death (by any cause in the absence of progression).|Tumour size assessed at week 8 (±1 week) and then every 8 weeks (±1 week)|Full analysis set||months|||Number
689489|NCT01457703|Secondary|Changes in Follicle Stimulating Hormone (FSH) (Aim 2)|Follicle-stimulating hormone was measured hourly during the 12 hour study visit, and was compared between the obese and normal weight groups.|Measured hourly and averaged over the 12 hour study visit|This study was divided into two aims, and only 12 obese and 11 normal weight women completed the study procedures for Aim 2 that allowed measure of FSH.||IU/L||Standard Deviation|Mean
689490|NCT01457703|Secondary|Changes in Follicle Stimulating Hormone (FSH) (Aim 1)|Follicle-stimulating hormone was measured hourly during the 12 hour study visit, and was compared between the obese and normal weight groups.|Measured hourly and averaged over the 12 hour study visit|This study was divided into two aims, and only 10 obese and 10 normal weight women completed the study procedures for Aim 1 that allowed measure of FSH.||IU/L||Inter-Quartile Range|Mean
689491|NCT01457703|Primary|Changes in Pregnanediol Glucuronide (PdG) (Aim 2)|Pregnanediol glucuronide (PdG) was collected daily over the course of one menstrual cycle and averaged.|Averaged over the length of menstrual cycle|This study was divided into two aims, and only 12 obese and 10 normal weight women completed the urine collection study procedures for Aim 2 that allowed measure of PdG.||ug/cycle||Standard Deviation|Mean
689492|NCT01457703|Primary|Changes in Luteinizing Hormone (LH) Pulse Amplitude (Aim 2)|Luteinizing Hormone (LH) Pulse Amplitude was measured hourly during the 12 hour study visit, and was compared between the obese and normal weight groups.|Measured hourly and averaged over the 12 hour study visit|This study was divided into two aims, and only 12 obese and 11 normal weight women completed the study procedures for Aim 2 that allowed measure of LH pulse amplitude.||IU/L||Standard Deviation|Mean
689493|NCT01457703|Primary|Changes in Luteinizing Hormone (LH) Pulse Amplitude (Aim 1)|Luteinizing Hormone (LH) Pulse Amplitude was measured hourly during the 12 hour study visit, and was compared between the obese and normal weight groups.|Measured hourly and averaged over the 12 hour study visit|This study was divided into two aims, and 10 obese and 10 normal weight women completed the study procedures and contributed data for analyses related to Aim 1.||IU/L||Inter-Quartile Range|Mean
689496|NCT01457430|Primary|Time to Complete or Near Complete Resolution From Onset of Symptoms|Time of onset of HAE attack, time icatibant was administered, and time to complete relief of symptoms were recorded in minutes. Time to complete relief of symptoms was defined as time from onset of symptoms to complete or near complete resolution as reported by the patient.|Time to complete or near complete resolution of symptoms as reported by the patient, an expected average of 8-10 hours|||minutes||Inter-Quartile Range|Median
689497|NCT01457417|Primary|Progression Free Survival (PFS) in Patients With Relapsed or Refractory Non-small Cell Lung Cancer (NSCLC)|For Part B only. The distribution of PFS was estimated using the Kaplan-Meier (KM) method. PFS was defined as the time from the date of signed informed consent to the first date of objectively determined progressive disease (Progression is defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) and International Multiple Myeloma Working Group (IMWG)) or death from any cause. For patients who were still alive at the time of analysis (ie, data cut-off date) and without evidence of tumor progression, PFS was censored at the date of the most recent objective progression-free observation.|Time from the date of signed informed consent to the first date of objectively determined progressive disease or death from any cause|Patients with advanced NSCLC receiving the study drug at 300 mg every 2 weeks in Part B||months||95% Confidence Interval|Median
689498|NCT01457417|Secondary|Objective Response Rate (ORR) in Patients With Relapsed or Refractory Non-small Cell Lung Cancer (NSCLC)|FAS : For both Parts A and B. Objective response rate is defined as the number of patients with overall best response of complete response (CR) or partial response (PR)|Part A: Every 2 months; Part B: after 1 month and every two cycles thereafter|FAS : NSCLC - All patients with NSCLC who received at least one dose of study treatment during Part A or Part B of the study. Two patients in treatment group 300 mg Q2W did not have assessments performed after Baseline.||participants||95% Confidence Interval|Number
689499|NCT01457417|Secondary|Objective Response Rate (ORR) in Oncologic Patients Who Are Refractory or Intolerant to Standard/Approved Therapies|For both Parts A and B. Objective response rate is defined as the number of patients with overall best response of complete response (CR) or partial response (PR)|Part A: Every 2 months; Part B: after 1 month and every two cycles thereafter|All patients with NSCLC who received at least one dose of study treatment during Part A or Part B of the study. One Patients from the 300 mg QW treatment group, and two patients from 300 mg Q2W treatment group did not have assessments performed after Baseline.||Participants||95% Confidence Interval|Number
689500|NCT01457417|Secondary|Overall Survival (OS) in Patients With Relapsed or Refractory NSCLC|For Part B only. OS was defined as the time from the date of signed informed consent to the date of death from any cause. For patients who were still alive as of the data cut-off date, OS time was censored on the date of the patient’s last contact (last contact for patients in post-discontinuation was the last date of contact in long-term follow-up eCRF).|Time from the date of signed informed consent to the date of death from any cause|For patients who are still alive as of the data cut-off date, OS time will be censored on the date of the patient’s last contact (last contact for patients in post-discontinuation = last Date of Contact in Long Term Follow-up eCRF).||Months||95% Confidence Interval|Median
689501|NCT01457417|Secondary|Progression Free Survival (PFS) in Patients Who Are Refractory or Intolerant to Standard/Approved Therapies|For both Parts A and B. PFS was defined as the time from the date of signed informed consent to the first date of objectively determined progressive disease (Progression is defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) and International Multiple Myeloma Working Group (IMWG)) or death from any cause. For patients who were still alive at the time of analysis (i.e, data cut-off date) and without evidence of tumor progression, PFS was censored at the date of the most recent objective progression-free observation.|Time from the date of signed informed consent to the first date of objectively determined progressive disease or death from any cause|All patients who received at least one dose of study treatment during Part A or Part B of the study.||Months||95% Confidence Interval|Median
689502|NCT01457417|Secondary|Pharmacokinetic: Maximum Plasma Concentration (Cmax) of DKN-01|Peak DKN-01 serum concentration (Cmax) after the fourth infusion on Cycle 1 Weeks 1 and 4, for both Parts A and B. Cycle 1 day 22 included only QW dosing groups.|Cycle 1 Day 22 (Fourth dose for QW groups)|All patients who received at least one dose of study treatment during Part A of the study.||ng/mL||Standard Deviation|Mean
689503|NCT01457417|Secondary|Pharmacokinetic: Maximum Plasma Concentration (Cmax) of DKN-01|Peak DKN-01 serum concentration (Cmax) after the first and fourth infusion on Cycle 1 Weeks 1 and 4, for both Parts A and B. Cycle 1 Day 1 included once per week (QW) dosing groups and every two weeks (Q2W) dosing groups.|Cycle 1 Day 1 (first dose, all groups)|All patients who received at least one dose of study treatment during Part A or Part B of the study.||ng/mL||Standard Deviation|Mean
689504|NCT01457417|Secondary|Pharmacokinetics: Area Under the Concentration - Time Curve (AUC) of DKN-01|Area under the DKN-01 serum concentration-time profile curve during the dosing interval (AUC0-tau) after the first and fourth infusion for both Parts A and B. Cycle 1 day 22 included only QW dosing groups.|Cycle 1 Day 22 (Fourth Dose for QW)|All patients who received at least one dose of study treatment during Part A study.||hr*ng/mL||Standard Deviation|Mean
689505|NCT01457417|Secondary|Pharmacokinetics: Area Under the Concentration - Time Curve (AUC) of DKN-01|Area under the DKN-01 serum concentration-time profile curve during the dosing interval (AUC0-tau) after the first and fourth infusion for both Parts A and B. Cycle 1 Day 1 included once per week (QW) dosing groups and every two weeks (Q2W) dosing groups.|Cycle 1 Day 1 (first dose, all groups)|All patients who received at least one dose of study treatment during Part A or Part B of the study.||hr*ng/mL||Standard Deviation|Mean
689506|NCT01457417|Primary|Summary of Patients With Adverse Events (AE)|Number of patients who had Adverse Events (AE) including treatment related treatment emergent adverse events (TEAE), Common Toxicity Criteria for Adverse Effects (CTCAE), and Serious Adverse Events (SAE) for both Parts A and B. Severity was coded to NCI CTCAE version 4.02. For maximum severity and relationship, patients were counted only once in the most severe or most related category.|Baseline to study completion (approximately 3 months)|Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study.||Patients|||Number
689655|NCT01456130|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|The change in the value of glycosylated hemoglobin collected at Week 52 or at the final visit relative to Baseline.|Baseline and Week 52|Full analysis set: All randomized participants who received at least one dose of double-blind study medication.||percentage of glycosylated hemoglobin||95% Confidence Interval|Mean
689507|NCT01457417|Primary|Summary of Total Adverse Events (AE)|Total Adverse Events (AE), total treatment emergent adverse events (TEAE), total Serious Adverse Events (SAE), and total dose-limiting toxicity (DLT) for both Parts A and B.|Baseline to study completion (approximately 3 months)|Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study.||Events|||Number
689508|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 250 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||Arcsine proportion correct||Standard Error|Mean
689509|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 200 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||Arcsine proportion correct||Standard Error|Mean
689510|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 150 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||Arcsine proportion correct||Standard Error|Mean
689511|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 100 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||Arcsine proportion correct||Standard Error|Mean
689512|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 70 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||Arcsine proportion correct||Standard Error|Mean
689513|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 50 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||Arcsine proportion correct||Standard Error|Mean
689549|NCT01457339|Secondary|Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 50 mg|CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||units on a scale||Standard Error|Mean
689514|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 250 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||Log10 milliseconds||Standard Error|Mean
689515|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 200 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||Log10 milliseconds||Standard Error|Mean
689516|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 150 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||Log10 milliseconds||Standard Error|Mean
689517|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 100 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||Log10 milliseconds||Standard Error|Mean
689518|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 70 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||Log10 milliseconds||Standard Error|Mean
689519|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 50 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||Log10 milliseconds||Standard Error|Mean
689520|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 250 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||Log10 milliseconds||Standard Error|Mean
731610|NCT00405288|Secondary|Prematurity|birth at <37 gestational weeks|at birth|||participants|||Number
689521|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 200 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||Log10 milliseconds||Standard Error|Mean
689522|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 150 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||Log10 milliseconds||Standard Error|Mean
689523|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 100 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||Log10 milliseconds||Standard Error|Mean
689524|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 70 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||Log10 milliseconds||Standard Error|Mean
689525|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 50 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||Log10 milliseconds||Standard Error|Mean
689526|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 250 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||Number of Errors||Standard Error|Mean
689527|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 200 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||Number of Errors||Standard Error|Mean
722128|NCT00307294|Primary|Response Rate||24 weeks|||percentage of participants||95% Confidence Interval|Number
689528|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 150 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||Number of Errors||Standard Error|Mean
689529|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 100 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||Number of Errors||Standard Error|Mean
689530|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 70 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||Number of Errors||Standard Error|Mean
689531|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 50 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||Number of Errors||Standard Error|Mean
689532|NCT01457339|Secondary|Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 250 mg|BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||units on a scale||Standard Error|Mean
689533|NCT01457339|Secondary|Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 200 mg|BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||units on a scale||Standard Error|Mean
689534|NCT01457339|Secondary|Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 150 mg|BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||units on a scale||Standard Error|Mean
689535|NCT01457339|Secondary|Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 100 mg|BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||units on a scale||Standard Error|Mean
690134|NCT01451398|Secondary|Change in Body Weight From Baseline to Week 24|Change in body weight from Baseline to Week 24|Baseline to Week 24|Full analysis set for patients with data at both Baseline and at Week 24||kg||Standard Error|Least Squares Mean
689536|NCT01457339|Secondary|Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 70 mg|BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||units on a scale||Standard Error|Mean
689537|NCT01457339|Secondary|Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 50 mg|BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||units on a scale||Standard Error|Mean
689538|NCT01457339|Secondary|Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 250 mg|SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||units on a scale||Standard Error|Mean
689539|NCT01457339|Secondary|Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 200 mg|SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||units on a scale||Standard Error|Mean
689540|NCT01457339|Secondary|Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 150 mg|SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||units on a scale||Standard Error|Mean
689541|NCT01457339|Secondary|Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 100 mg|SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||units on a scale||Standard Error|Mean
689542|NCT01457339|Secondary|Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 70 mg|SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||units on a scale||Standard Error|Mean
689543|NCT01457339|Secondary|Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 50 mg|SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||units on a scale||Standard Error|Mean
689544|NCT01457339|Secondary|Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 250 mg|CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||units on a scale||Standard Error|Mean
689545|NCT01457339|Secondary|Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 200 mg|CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||units on a scale||Standard Error|Mean
689546|NCT01457339|Secondary|Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 150 mg|CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||units on a scale||Standard Error|Mean
689547|NCT01457339|Secondary|Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 100 mg|CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||units on a scale||Standard Error|Mean
689548|NCT01457339|Secondary|Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 70 mg|CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||units on a scale||Standard Error|Mean
689550|NCT01457339|Secondary|Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 250 mg|The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||units on a scale||Standard Error|Mean
689551|NCT01457339|Secondary|Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 200 mg|The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||units on a scale||Standard Error|Mean
689552|NCT01457339|Secondary|Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 150 mg|The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||units on a scale||Standard Error|Mean
689553|NCT01457339|Secondary|Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 100 mg|The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||units on a scale||Standard Error|Mean
689554|NCT01457339|Secondary|Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 70 mg|The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||units on a scale||Standard Error|Mean
689555|NCT01457339|Secondary|Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 50 mg|The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||units on a scale||Standard Error|Mean
689556|NCT01457339|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 250 mg|The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||units on a scale||Standard Error|Mean
689557|NCT01457339|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 200 mg|The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||units on a scale||Standard Error|Mean
689558|NCT01457339|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 150 mg|The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||units on a scale||Standard Error|Mean
689559|NCT01457339|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 100 mg|The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||units on a scale||Standard Error|Mean
689560|NCT01457339|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 70 mg|The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||units on a scale||Standard Error|Mean
689581|NCT01457339|Secondary|Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 70 mg|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Day 5 (12-hour sampling period post-dose)|Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.||ng/ml||Standard Deviation|Mean
689561|NCT01457339|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 50 mg|The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||units on a scale||Standard Error|Mean
689562|NCT01457339|Secondary|Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 250 mg|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Day 5 (12-hour sampling period post-dose)|Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.||ng/ml||Standard Deviation|Mean
689563|NCT01457339|Secondary|Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 200 mg|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Day 5 (12-hour sampling period post-dose)|Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.||ng/ml||Standard Deviation|Mean
689564|NCT01457339|Secondary|Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 150 mg|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Day 5 (12-hour sampling period post-dose)|Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.||ng/ml||Standard Deviation|Mean
689565|NCT01457339|Secondary|Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 100 mg|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Day 5 (12-hour sampling period post-dose)|Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.||ng/ml||Standard Deviation|Mean
689566|NCT01457339|Primary|Change From Baseline in Pulse Rate at Day 5: 250 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||beats/min||Standard Deviation|Mean
689567|NCT01457339|Primary|Change From Baseline in Pulse Rate at Day 5: 200 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||beats/min||Standard Deviation|Mean
689568|NCT01457339|Primary|Change From Baseline in Pulse Rate at Day 5: 150 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||beats/min||Standard Deviation|Mean
689569|NCT01457339|Primary|Change From Baseline in Pulse Rate at Day 5: 100 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||beats/min||Standard Deviation|Mean
689570|NCT01457339|Primary|Change From Baseline in Pulse Rate at Day 5: 70 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||beats/min||Standard Deviation|Mean
689571|NCT01457339|Primary|Change From Baseline in Pulse Rate at Day 5: 50 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||beats/min||Standard Deviation|Mean
722129|NCT00307333|Secondary|Mortality||120 days|||participants|||Number
689572|NCT01457339|Primary|Change From Baseline in Diastolic Blood Pressure at Day 5: 250 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||mmHg||Standard Deviation|Mean
689573|NCT01457339|Primary|Change From Baseline in Diastolic Blood Pressure at Day 5: 200 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||mmHg||Standard Deviation|Mean
689574|NCT01457339|Primary|Change From Baseline in Diastolic Blood Pressure at Day 5: 150 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||mmHg||Standard Deviation|Mean
689575|NCT01457339|Primary|Change From Baseline in Diastolic Blood Pressure at Day 5: 100 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||mmHg||Standard Deviation|Mean
689576|NCT01457339|Primary|Change From Baseline in Diastolic Blood Pressure at Day 5: 70 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||mmHg||Standard Deviation|Mean
689577|NCT01457339|Primary|Change From Baseline in Diastolic Blood Pressure at Day 5: 50 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||mmHg||Standard Deviation|Mean
689578|NCT01457339|Primary|Change From Baseline in Systolic Blood Pressure at Day 5: 250 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||mmHg||Standard Deviation|Mean
689579|NCT01457339|Primary|Change From Baseline in Systolic Blood Pressure at Day 5: 200 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||mmHg||Standard Deviation|Mean
689580|NCT01457339|Primary|Change From Baseline in Systolic Blood Pressure at Day 5: 150 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||mmHg||Standard Deviation|Mean
718031|NCT00285779|Secondary|The Physician Assessment of Surface Area of Disease, PSAD, (Mucosal Erosions and Cutaneous Disease) at 12 and 24 Weeks||24 weeks||||||
689582|NCT01457339|Secondary|Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 50 mg|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Day 5 (12-hour sampling period post-dose)|Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.||ng/ml||Standard Deviation|Mean
689583|NCT01457339|Secondary|Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 250 mg|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Day 5 (12-hour sampling period post-dose)|Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.||ng*hr/ml||Standard Deviation|Mean
689584|NCT01457339|Secondary|Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 200 mg|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Day 5 (12-hour sampling period post-dose)|Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.||ng*hr/ml||Standard Deviation|Mean
689585|NCT01457339|Secondary|Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 150 mg|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Day 5 (12-hour sampling period post-dose)|Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.||ng*hr/ml||Standard Deviation|Mean
689586|NCT01457339|Secondary|Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 100 mg|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Day 5 (12-hour sampling period post-dose)|Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.||ng*hr/ml||Standard Deviation|Mean
689587|NCT01457339|Secondary|Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 70 mg|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Day 5 (12-hour sampling period post-dose)|Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.||ng*hr/ml||Standard Deviation|Mean
689588|NCT01457339|Secondary|Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 50 mg|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Day 5 (12-hour sampling period post-dose)|Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.||ng*hr/ml||Standard Deviation|Mean
689589|NCT01457339|Primary|Change From Baseline in Systolic Blood Pressure at Day 5: 100 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||mmHg||Standard Deviation|Mean
689590|NCT01457339|Primary|Change From Baseline in Systolic Blood Pressure at Day 5: 70 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||mmHg||Standard Deviation|Mean
689591|NCT01457339|Primary|Change From Baseline in Systolic Blood Pressure at Day 5: 50 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||mmHg||Standard Deviation|Mean
689592|NCT01457053|Primary|Myocardial Blood Flow|Evaluate the effects of ultrafiltration (UF) compared to intravenous diuretic therapy on myocardial blood flow (MBF) and coronary flow reserve (CFR), as assessed by positron emission tomography (PET), in patients with acutely decompensated heart failure (ADHF).|1 - 5 days|No data analyzed due to inadequate enrollment.|||||
689593|NCT01457014|Secondary|Number of Arterial Oxygen Saturation Per Hour|Arterial Oxygen Saturation was compared among using no treatment, CPAP, Auto SV and Manual SV.|four full night Polysomnography (PSG's)|||times per hour||Standard Deviation|Mean
689594|NCT01457014|Secondary|Percent Oxygen Saturation|Oxygen Saturation were compared among using no treatment, CPAP, Auto SV and Manual SV.|four full night Polysomnography (PSG's)|||percentage of oxygen saturation||Standard Deviation|Mean
689595|NCT01457014|Primary|Number of Sleep Related Events Per Hour|The number of Apnea-Hypopnea Events, Central Apneas, Obstructive Apneas and Hypopneas were compared among no treatment, CPAP, Auto SV and Manual SV.|four full night Polysomnography (PSG's)|After the Diagnostic Polysomnography (PSG) each participant completed a night in each arm.||events/hour||Standard Deviation|Mean
718032|NCT00285779|Secondary|The Percentage of Patients Achieving a Response in Cutaneous or Mucosal Disease at 24 Weeks||24 weeks||||||
689596|NCT01456962|Primary|CD4+ to CD8+ T Cell Ratio in Cervical Biopsies|Evaluation of cervical immune health in HIV-infected women on tenofovir (TDF) and emtricitabine (FTC) and either raltegravir or atazanavir. Cervical CD4+ to CD8+ T cell ratios will be measured at one time point from cervical biopsies. Higher ratios will be a measure of better cervical immune health. In addition, ratios will be compared to the concentration of the drug in the genital tract.|12 hours after the last medication dose|||Cervical CD4+:CD8+ T cell ratio||95% Confidence Interval|Geometric Mean
689597|NCT01456936|Secondary|7‑Day Point Prevalence of Abstinence (Overall)|"A responder to this endpoint requires the answer “no” to both questions 3 and 6 on the nicotine use inventory at that specific visit.
NUI Question 3 (Baseline through Week 24): Has the subject smoked any cigarettes (even a puff) in the last 7 days? NUI Question 6 (Baseline through Week 12): Has the subject used any other nicotine containing products in the last 7 days? NUI Question 6 (Week 13 through Week 24): Has the subject used any other tobacco products in the last 7 days?"|24 Weeks|The full analysis set was defined under the ITT principle as all randomized participants (N=8144) and was used for all efficacy endpoints.||percentage of participants|||Number
689598|NCT01456936|Secondary|7‑Day Point Prevalence of Abstinence, Psychiatric History Cohort|"A responder to this endpoint requires the answer “no” to both questions 3 and 6 on the nicotine use inventory at that specific visit.
NUI Question 3 (Baseline through Week 24): Has the subject smoked any cigarettes (even a puff) in the last 7 days? NUI Question 6 (Baseline through Week 12): Has the subject used any other nicotine containing products in the last 7 days? NUI Question 6 (Week 13 through Week 24): Has the subject used any other tobacco products in the last 7 days?"|24 Weeks|The full analysis set was defined under the ITT principle as all randomized participants (N=8144) and was used for all efficacy endpoints.||percentage of participants|||Number
689599|NCT01456936|Secondary|7‑Day Point Prevalence of Abstinence, Non-psychiatric History Cohort|"A responder to this endpoint requires the answer “no” to both questions 3 and 6 on the nicotine use inventory at that specific visit.
NUI Question 3 (Baseline through Week 24): Has the subject smoked any cigarettes (even a puff) in the last 7 days? NUI Question 6 (Baseline through Week 12): Has the subject used any other nicotine containing products in the last 7 days? NUI Question 6 (Week 13 through Week 24): Has the subject used any other tobacco products in the last 7 days?"|24 Weeks|The full analysis set was defined under the ITT principle as all randomized participants (N=8144) and was used for all efficacy endpoints.||percentage of participants|||Number
689600|NCT01456936|Secondary|CO-confirmed Continuous Abstinence From Week 9 Through Week 24 (Overall)|A responder to this endpoint requires the answer “no” to both questions 1 and 2 on the Nicotine Use Inventory at every visit from Week 9 to Week 24 (inclusive).|Week 9 through Week 24|The full analysis set was defined under the ITT principle as all randomized participants (N=8144) and was used for all efficacy endpoints.||percentage of participants|||Number
689601|NCT01456936|Secondary|CO-confirmed Continuous Abstinence From Week 9 Through Week 24, Psychiatric History Cohort|A responder to this endpoint requires the answer “no” to both questions 1 and 2 on the Nicotine Use Inventory at every visit from Week 9 to Week 24 (inclusive).|Week 9 through Week 24|The full analysis set was defined under the ITT principle as all randomized participants (N=8144) and was used for all efficacy endpoints.||percentage of participants|||Number
689602|NCT01456936|Secondary|CO-confirmed Continuous Abstinence From Week 9 Through Week 24, Non-psychiatric History Cohort|A responder to this endpoint requires the answer “no” to both questions 1 and 2 on the Nicotine Use Inventory at every visit from Week 9 to Week 24 (inclusive).|Week 9 through Week 24|The full analysis set was defined under the ITT principle as all randomized participants (N=8144) and was used for all efficacy endpoints.||percentage of participants|||Number
689603|NCT01456936|Secondary|CO‑Confirmed Continuous Abstinence for Weeks 9 Through 12 (Overall)|A responder to this endpoint requires the answer “no” to both questions 1 and 2 on the Nicotine Use Inventory at every visit from Week 9 to Week 12 (inclusive).|Week 9 through Week 12|The full analysis set was defined under the ITT principle as all randomized participants (N=8144) and was used for all efficacy endpoints.||percentage of participants|||Number
689604|NCT01456936|Secondary|CO‑Confirmed Continuous Abstinence for Weeks 9 Through 12, Psychiatric History Cohort|A responder to this endpoint requires the answer “no” to both questions 1 and 2 on the Nicotine Use Inventory at every visit from Week 9 to Week 12 (inclusive).|Week 9 through Week 12|The full analysis set was defined under the ITT principle as all randomized participants (N=8144) and was used for all efficacy endpoints.||percentage of participants|||Number
689605|NCT01456936|Secondary|CO‑Confirmed Continuous Abstinence for Weeks 9 Through 12, Non-psychiatric History Cohort|A responder to this endpoint requires the answer “no” to both questions 1 and 2 on the Nicotine Use Inventory at every visit from Week 9 to Week 12 (inclusive).|Week 9 through Week 12|The full analysis set was defined under the intent-to-treat (ITT) principle as all randomized participants (N=8144) and was used for all efficacy endpoints.||percentage of participants|||Number
689606|NCT01456936|Secondary|"Clinical Global Impression of Improvement (CGI‑I), No Change Rating by Visit"|"The CGI-I is a clinician rated instrument that measures change in participant's psychiatric condition (or lack thereof in the stratum without psychiatric disorders) on a 7 point scale ranging from 1 (very much improved) to 7 (very much worse), with 4 = no change. The ratings were applicable even to those without psychiatric diagnoses (eg, those with no psychiatric symptoms would be rated as normal, not at all ill on the CGI-S at baseline and assuming no psychiatric symptoms emerge during the trial, would be rated as no change on the CGI-I at follow-up visits). For those participants with a psychiatric diagnosis, the clinician should rate the severity of the mental illness with respect to the clinician's experience with the psychiatric population to which the participant belongs."|Baseline to Week 24|The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.||percentage of participants|||Number
689627|NCT01456299|Primary|LMA Insertion Condition|The pre-determined effect-site concentration of remifentanil or normal saline was administered according to the patient's group.LMAs were size #3 for women and #4 for men.The conditions of the LMA insertion were graded on a three point scale using six variables (mouth opening, ease of LMA insertion, swallowing, coughing and gagging, head and body movements, laryngospasm). Each of these variables was rated as excellent, intermediate or poor.|at that time on LMA insertion only|||participants|||Number
690135|NCT01451398|Secondary|Mean 7-point Glucose Week 24 Values|Mean 7-point self-monitored blood glucose at Week 24|Week 24|Full analysis set for patients with data at Week 24||mg/dL||Standard Deviation|Mean
689607|NCT01456936|Secondary|Positive Responses for Suicidal Behavior and/or Ideation by Columbia Suicide Severity Rating Scale (C‑SSRS) - Overall|"The C-SSRS is a semi-structured interview designed to evaluate an individual's degree of suicidal ideation, preparatory acts or behavior to actual attempt, ranging from wish to be dead to active suicidal ideation with specific plan and intent. Answers at screening are for lifetime history. Answers for all other visits are since last visit. The scale is also used to record any completed suicides."|Lifetime, Baseline and Treatment-Emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.|The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.||participants with positive responses|||Number
689608|NCT01456936|Secondary|Positive Responses for Suicidal Behavior and/or Ideation by Columbia Suicide Severity Rating Scale (C‑SSRS) - Psychiatric History Cohort|"The C-SSRS is a semi-structured interview designed to evaluate an individual's degree of suicidal ideation, preparatory acts or behavior to actual attempt, ranging from wish to be dead to active suicidal ideation with specific plan and intent. Answers at screening are for lifetime history. Answers for all other visits are since last visit. The scale is also used to record any completed suicides."|Lifetime, Baseline and Treatment-Emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.|The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.||participants with positive responses|||Number
689609|NCT01456936|Secondary|Positive Responses for Suicidal Behavior and/or Ideation by Columbia Suicide Severity Rating Scale (C‑SSRS) - Non-psychiatric History Cohort|"The C-SSRS is a semi-structured interview designed to evaluate an individual's degree of suicidal ideation, preparatory acts or behavior to actual attempt, ranging from wish to be dead to active suicidal ideation with specific plan and intent. Answers at screening are for lifetime history. Answers for all other visits are since last visit.The scale is also used to record any completed suicides."|Lifetime, Baseline and Treatment-Emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.|The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.||participants with positive responses|||Number
689610|NCT01456936|Secondary|HADS Total Score (Overall)|The HADS is a subject self-reporting scale completed in person at clinic visits at Baseline and Weeks 1 through 6, 8, 10, 12, 13, 16, 20, and 24. It contains 14 individual item responses ranging in increasing severity from 0 (normal) to 3 (most severe) for a total range of 0 to 42. Of the 14 items, 7 assess anxiety and 7 assess depression, providing 2 subscales with ranges of 0 to 21. For each subscale, 0 to 7 is considered normal, while 15 to 21 represents severe symptoms.|Baseline to Week 24|The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.||Units on a scale||Standard Deviation|Mean
689611|NCT01456936|Secondary|HADS Total Score, Psychiatric History Cohort|The HADS is a subject self-reporting scale completed in person at clinic visits at Baseline and Weeks 1 through 6, 8, 10, 12, 13, 16, 20, and 24. It contains 14 individual item responses ranging in increasing severity from 0 (normal) to 3 (most severe) for a total range of 0 to 42. Of the 14 items, 7 assess anxiety and 7 assess depression, providing 2 subscales with ranges of 0 to 21. For each subscale, 0 to 7 is considered normal, while 15 to 21 represents severe symptoms.|Baseline to Week 24|The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.||Units on a scale||Standard Deviation|Mean
689612|NCT01456936|Secondary|Hospital Anxiety and Depression Scale (HADS) Total Score, Non-psychiatric History Cohort|The HADS is a subject self-reporting scale completed in person at clinic visits at Baseline and Weeks 1 through 6, 8, 10, 12, 13, 16, 20, and 24. It contains 14 individual item responses ranging in increasing severity from 0 (normal) to 3 (most severe) for a total range of 0 to 42. Of the 14 items, 7 assess anxiety and 7 assess depression, providing 2 subscales with ranges of 0 to 21. For each subscale, 0 to 7 is considered normal, while 15 to 21 represents severe symptoms.|Baseline to Week 24|The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.||Units on a scale||Standard Deviation|Mean
689613|NCT01456936|Secondary|Occurrence of the Components of Severe-only NPS AE Endpoint (Overall)|The NPS AE endpoint was the occurrence of at least 1 treatment-emergent “severe” AE of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least 1 treatment-emergent “severe” AE of agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Only those events rated as severe are reported; this excludes any moderate events in the primary NPS AE endpoint.|Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.|The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.||participants|||Number
689614|NCT01456936|Secondary|Occurrence of the Components of the Observed Severe-only NPS AE Primary Endpoint, Psychiatric History Cohort|The safety endpoint is the occurrence of at least one treatment emergent “severe” adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent “moderate” or “severe” adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Only those events rated as severe are reported; this excludes any moderate events in the primary NPS AE endpoint.|Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.|The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.||participants|||Number
689615|NCT01456936|Secondary|Occurrence of the Components of the Observed Severe-only NPS AE Primary Endpoint, Non-psychiatric History Cohort|The safety endpoint is the occurrence of at least one treatment emergent “severe” adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent “moderate” or “severe” adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Only those events rated as severe are reported; this excludes any moderate events in the primary NPS AE endpoint.|Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.|The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.||participants|||Number
689616|NCT01456936|Secondary|Occurrence of Severe-only NPS AEs in the Primary Endpoint, by Cohort|The primary safety endpoint is the occurrence of at least one treatment emergent “severe” adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent “moderate” or “severe” adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Only those events rated as severe are reported; this excludes any moderate events in the primary NPS AE endpoint.|Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.|The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.||percentage of participants|||Number
689617|NCT01456936|Secondary|Occurrence of the Components of NPS AE Primary Endpoint (Overall)|The NPS AE composite results (as previously described) are for the two cohorts combined and are presented below.|Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.|The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.||participants|||Number
689618|NCT01456936|Secondary|Occurrence of the Components of the NPS AE Primary Endpoint, Psychiatric History Cohort|The safety endpoint is the occurrence of at least one treatment emergent “severe” adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent “moderate” or “severe” adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Each of these 16 components is reported below.|Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.|The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.||participants|||Number
689619|NCT01456936|Secondary|Occurrence of the Components of the NPS AE Primary Endpoint, Non-psychiatric History Cohort|The safety endpoint is the occurrence of at least one treatment emergent “severe” adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent “moderate” or “severe” adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Each of these 16 components is reported below.|Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.|The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.||participants|||Number
689620|NCT01456936|Primary|Estimated NPS AE Rate (%), by Cohort|The primary safety endpoint is the occurrence of at least one treatment emergent “severe” adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent “moderate” or “severe” adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Estimated NPS AE rate (%) was calculated based on least-squares means analysis.|Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.|The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.||percentage of participants||95% Confidence Interval|Least Squares Mean
689621|NCT01456936|Primary|Occurrence of Neuropsychiatric (NPS) Adverse Events (AE) - the Primary Study Endpoint|The primary safety endpoint is the occurrence of at least one treatment emergent “severe” adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent “moderate” or “severe” adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide.|Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.|The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.||percentage of participants|||Number
689622|NCT01456780|Primary|Corneal Fluorescein Staining Score|Corneal Fluorescein Staining is used to assess the level of corneal epitheliopathy that is related to dry eye disease. The CFS scale ranges from 0 to 15 scale, with 0 representing the minimum level of corneal epitheliopathy and 15 representing the maximum level of corneal epitheliopathy.|Week 4 Time Point|||units on a scale||Standard Deviation|Mean
689623|NCT01456780|Primary|Symptom Assessment iN Dry Eye (SANDE) Severity Score|Questionnaire given to patients to assess the severity of dry eye symptoms. The questionnaire utilizes a 100 mm horizontal Visual Analogue Scale technique to quantify the severity of the patient’s dry eye symptoms. Change is quantified from baseline to week 4. The range of the SANDE severity scale is 0-100, with minimum level of severity of dry eye symptoms and 100 being the maximum level of severity of dry eye symptoms.|Week 4 Time Point|||units on a scale||Standard Deviation|Mean
689624|NCT01456780|Primary|Symptom Assessment iN Dry Eye (SANDE) Frequency Score|Questionnaire given to patients to assess the frequency of dry eye symptoms. The questionnaire utilizes a 100 mm horizontal Visual Analogue Scale technique to quantify the frequency of the patient’s dry eye symptoms. Change is quantified from baseline to week 4. The range of the SANDE frequency scale is 0-100, with 0 being the minimum level of frequency of dry eye symptoms and 100 being the maximum level of frequency of dry eye symptoms.|Week 4 Time Point|||units on a scale||Standard Deviation|Mean
689625|NCT01456780|Primary|Ocular Surface Disease Index|OSDI is a 12-question survey used to measure the symptoms of dry eye disease. Each of the 12 individual questions rate one symptom on a 0-4 scale, with 4 meaning that the symptom is present all of the time and 0 meaning the symptom is present none of the time. The overall ODSI score is calculated by adding all of the values from the 12 questions, multiplying that value by 25, and dividing the resulting value by the number of questions answered. This results in an overall scale that ranges from 0-100, with 100 being severe dry eye symptoms and 0 being no dry eye symptoms.|Week 4 Time Point|||units on a scale||Standard Deviation|Mean
689626|NCT01456299|Secondary|Frequency of Apnea|If prolonged apnoea (> 30 s) developed, manual ventilation was assisted. And record the frequency of apnea on each group|baseline, 30sec after drug injection||||||
689653|NCT01456130|Secondary|Change From Baseline in Fasting Glucose|The change in the value of fasting glucose collected at Week 52 or the final visit relative to Baseline.|Baseline and Week 52|Full analysis set.||mg/dL||95% Confidence Interval|Mean
722130|NCT00307333|Secondary|Days on Antibiotics||120 days|||days||Standard Deviation|Mean
689628|NCT01456195|Secondary|Change From Baseline in 2-hour Postprandial Glucose (PPG) Following a Meal Tolerance Test (MTT)|The change between the value of glucose after a meal, measured by the meal tolerance test collected at Week 24 relative to Baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and 2 hours after the start of the meal measured in millimoles per liter (mmol/L). An Analysis of Covariance (ANCOVA) model with treatment and country as fixed factors and Baseline value as covariate was used for analysis.|Baseline and Week 24|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug, with data available for analysis. Only participants with Baseline and at least 1 post-Baseline value are included. MTT were only done at sites that had MTT capabilities.||mmol/L||Standard Error|Least Squares Mean
689629|NCT01456195|Secondary|Change From Baseline in Fasting Plasma Glucose|The change between the fasting plasma glucose value collected at Week 24 relative to Baseline measured in milligrams per deciliter (mg/dL). A MMRM model with treatment, country, visit and visit by treatment interaction as fixed factors and with Baseline value and Baseline value by visit interaction as covariates with an unstructured covariance structure was used for analysis.|Baseline and Week 24|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug, with data available for analysis. Only participants with Baseline and at least 1 post-Baseline value are included.||mg/dL||Standard Error|Least Squares Mean
689630|NCT01456195|Secondary|Incidence of HbA1c <7%|The incidence (percentage of participants with) HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) of less than seven percent for target glycemic control at Week 24.|Week 24|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug, with data available for analysis. Only participants with Baseline and at least 1 post-Baseline value are included. Last Observation Carried Forward.||percentage of participants|||Number
689631|NCT01456195|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 24 relative to Baseline. A mixed model repeated measures (MMRM) model with treatment, country, visit and visit by treatment interaction as fixed factors and with Baseline value and Baseline value by visit interaction as covariates with an unstructured covariance structure was used for analysis.|Baseline and Week 24|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug, with data available for analysis. Only participants with Baseline and at least 1 post-Baseline value are included.||percent||Standard Error|Least Squares Mean
689632|NCT01456169|Secondary|Percentage of Participants Who Achieve Both Clinic Systolic and Diastolic Blood Pressure Targets at Week 8|Percentage of participants who achieve both clinic systolic and diastolic blood pressure targets at Week 8, defined as less than 140 mm Hg (or less than 130 mm Hg for participants with diabetes or chronic kidney disease) for systolic AND less than 90 mm Hg (or less than 80 mm Hg for participants with diabetes or chronic kidney disease) for diastolic blood pressure.|Week 8|Full analysis set||percentage of participants|||Number
689633|NCT01456169|Secondary|Percentage of Participants Who Achieve a Target Clinic Diastolic Blood Pressure at Week 8|Percentage of participants who achieve a target clinic diastolic blood pressure measured at final visit or week 8, defined as less than 90 mm Hg (or less than 80 mm Hg for participants with diabetes or chronic kidney disease). Diastolic blood pressure is based on the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements.|Week 8|Full analysis set||percentage of participants|||Number
689634|NCT01456169|Secondary|Percentage of Participants Who Achieve a Target Clinic Systolic Blood Pressure at Week 8|Percentage of participants who achieve a target clinic systolic blood pressure measured at final visit or week 8, defined as less than 140 mm Hg (or less than 130 mm Hg for participants with diabetes or chronic kidney disease). Systolic blood pressure is the arithmetic mean of the 3 trough sitting Systolic blood pressure measurements.|Week 8|Full analysis set||percentage of participants|||Number
689635|NCT01456169|Secondary|Change From Baseline to Week 8 in the Mean Diastolic Blood Pressure 0 to 12 Hours After Dosing, as Measured by Ambulatory Blood Pressure Monitoring|The change in the 12-hour mean diastolic blood pressure measured at final visit or Week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 8|Full analysis set. Only participants with a Baseline and at least 1 post-baseline value of acceptable quality were included.||mm Hg||Standard Error|Least Squares Mean
689636|NCT01456169|Secondary|Change From Baseline to Week 8 in the Mean Systolic Blood Pressure 0 to 12 Hours After Dosing, as Measured by Ambulatory Blood Pressure Monitoring|The change in the 12-hour mean systolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 8|Full analysis set. Only participants with a Baseline and at least 1 post-baseline value of acceptable quality were included.||mm Hg||Standard Error|Least Squares Mean
689637|NCT01456169|Secondary|Change From Baseline to Week 8 in the Mean Nighttime Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring|The change in nighttime (12 am to 6 am) mean diastolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 8.|Full analysis set. Only participants with a Baseline and at least 1 post-baseline value of acceptable quality were included.||mm Hg||Standard Error|Least Squares Mean
689638|NCT01456169|Secondary|Change From Baseline to Week 8 in the Mean Nighttime Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring|The change in nighttime (12 am to 6 am) mean systolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 8|Full analysis set. Only participants with a Baseline and at least 1 post-baseline value of acceptable quality were included.||mm Hg||Standard Error|Least Squares Mean
690136|NCT01451398|Secondary|Mean 7-point Glucose Baseline Values|Mean 7-point self-monitored glucose at baseline|Baseline|Full analysis set||mg/dL||Standard Deviation|Mean
689639|NCT01456169|Secondary|Change From Baseline to Week 8 in the Mean Daytime Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring|The change in daytime (6 am to 10 pm) mean diastolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 8|Full analysis set. Only participants with a Baseline and at least 1 post-baseline value of acceptable quality were included.||mm Hg||Standard Error|Least Squares Mean
689640|NCT01456169|Secondary|Change From Baseline to Week 8 in the Mean Daytime Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring|The change in daytime (6 am to 10 pm) mean systolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 8|Full analysis set. Only participants with a Baseline and at least 1 post-baseline value of acceptable quality were included.||mm Hg||Standard Error|Least Squares Mean
689641|NCT01456169|Secondary|Change From Baseline to Week 8 in the 24-hour Mean Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring|The change in 24-hour mean diastolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 8|Full analysis set. Only participants with a Baseline and at least 1 post-baseline value of acceptable quality were included.||mm Hg||Standard Error|Least Squares Mean
689642|NCT01456169|Secondary|Change From Baseline to Week 8 in the 24-hour Mean Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring|The change in 24-hour mean systolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 8|Full analysis set. Only participants with a Baseline and at least 1 post-baseline value of acceptable quality were included.||mm Hg||Standard Error|Least Squares Mean
689643|NCT01456169|Secondary|Change From Baseline to Week 8 in Trough Diastolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring|The change in trough diastolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 8, 22-24 hours after dosing|Full analysis set. Only participants with a Baseline and at least 1 post-baseline value of acceptable quality were included||mm Hg||Standard Error|Least Squares Mean
689644|NCT01456169|Secondary|Change From Baseline to Week 8 in Trough Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring|The change in trough systolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 8, 22-24 hours after dosing|Full analysis set. Only participants with a baseline and at least 1 post-baseline value of acceptable quality were included.||mm Hg||Standard Error|Least Squares Mean
689645|NCT01456169|Secondary|Change From Baseline to Week 8 in Trough, Sitting, Clinic Diastolic Blood Pressure|The change between trough diastolic blood pressure measured at final visit or week 8 relative to baseline Diastolic blood pressure is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements.|Baseline and Week 8|Full analysis set; LOCF was used.||mm Hg||Standard Error|Least Squares Mean
689646|NCT01456169|Primary|Change From Baseline to Week 8 in Trough, Sitting, Clinic Systolic Blood Pressure|The change between trough systolic blood pressure measured at final visit or Week 8 relative to baseline. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.|Baseline (of the double-blind treatment period) and Week 8|Full analysis set, consisting of all randomized participants who received at least 1 dose of double-blind study drug. A participant was included in the analyses only when there was both a baseline value and at least 1 value during the double-blind treatment period. Last observation carried forward (LOCF) was used.||mm Hg||Standard Error|Least Squares Mean
689647|NCT01456143|Primary|Interrater Reliability|Amount of agreement among the 11 blinded head and neck cancer specialists, determined by the Fleiss Kappa. 33 benign and 65 cancer images were evaluated by the reviewers who were blinded to the anatomical site, tumor subsite, and final histopathologic diagnosis. Each reviewer was asked to classify each image as benign or neoplastic. The reviewers evaluated the images based on nuclear size, nuclear to cytoplasmic ratio, and overall cell architecture. Images were randomized in their presentation to the reviewers as to not establish any pattern. Each reviewer provided their interpretation in isolated settings to avoid influence from other reviewers.|Immediately following image (day of enrollment or up to 2 weeks after enrollment)|||proportion of agreement among 11 experts||95% Confidence Interval|Number
689648|NCT01456143|Primary|Negative Predictive Value|NPV = proportion of those with a negative test without neoplasia compared to pathology results|Immediately following image (day of enrollment or up to 2 weeks after enrollment)|||Percent of images with correct diagnosis||95% Confidence Interval|Mean
689649|NCT01456143|Primary|Positive Predictive Value|PPV = proportion of those with a positive test who have neoplasia compared to pathology results|Immediately following image (day of enrollment or up to 2 weeks after enrollment)|||Percent of images with correct diagnosis||95% Confidence Interval|Mean
689650|NCT01456143|Primary|Specificity|Specificity = Probability that the HRME correctly classifies as negative those without neoplasia compared to pathology results|Immediately following image (day of enrollment or up to 2 weeks after enrollment)|||Percent of images with correct diagnosis||95% Confidence Interval|Mean
689651|NCT01456143|Primary|Sensitivity|Sensitivity = probability that the HRME correctly classifies as positive those with neoplasia compared to pathology results|Immediately following image (day of enrollment or up to 2 weeks after enrollment)|||Percent of images with correct diagnosis||95% Confidence Interval|Mean
689652|NCT01456143|Primary|Accuracy|Accuracy of reviewers in differentiating neoplastic or benign mucosa in comparison to the pathology results|Immediately following image (day of enrollment or up to 2 weeks after enrollment)|||Percent of images with correct diagnosis||95% Confidence Interval|Mean
722131|NCT00307333|Secondary|Duration of Hospital Stay||120 days|||days||Standard Deviation|Mean
689656|NCT01456130|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs)|An TEAE is any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have a causal relationship with this treatment. A serious TEAE is defined as any untoward medical occurrence that resulted in death, was life threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability or incapacity, led to a congenital anomaly/birth defect or was an important medical event that may have required intervention to prevent any of items above.|52 Weeks|Safety analysis set - All participants who received at least one dose of the investigational product (alogliptin) and a rapid-acting insulin secretagogue.||participants|||Number
689657|NCT01456052|Secondary|Change From Baseline in Total Modified Mayo Score|A modified Mayo score was used to evaluate disease activity using 4 components, including stool frequency, rectal bleeding, endoscopy, and physician assessment. Components = Stool frequency score 0-3 (normal- >4 stools/day more than normal), rectal bleeding score 0-3 (none-passing blood alone), mucosal appearance at endoscopy 0-3 (normal-severe disease), physician rating of disease activity 0-3 (normal-severe). The total Modified Mayo score ranges from 0 to 12, with higher scores indicating greater disease severity.|Baseline to 8 weeks|||units on a scale||Standard Deviation|Mean
689658|NCT01456052|Secondary|Number of Subjects Achieving Clinical Remission|Clinical remission is defined as a total modified Mayo score ≤2 with no individual score >1 at Week 8.|Baseline to 8 weeks|||participants|||Number
689659|NCT01456052|Secondary|Number of Subjects Achieving Clinical Response|Clinical response is defined as a decrease in the total modified Mayo score from baseline of ≥3 or a ≥30% decrease in the total modified Mayo score from baseline, along with a decrease in the rectal bleeding score ≥1 or an absolute rectal bleeding score ≤1 at Week 8.|Baseline to 8 weeks|||participants|||Number
689660|NCT01456052|Primary|Number of Subjects Experiencing a Treatment Emergent Adverse Event||8 weeks|||participants|||Number
689661|NCT01456039|Secondary|Kaplan Meier (K-M) Estimate of Time to Progression (TTP) in PTCL Participants Based on the Modified 2007 IWC as Assessed by IER|Time to progression (≥50% increase from the nadir in the individual sum of the products of the diameters of any index lesion; the reappearance of pathology, enlargement of liver/spleen, or unequivocal progression of non-measurable disease or appearance of any new lesions) was defined as the duration from the date of the first study drug dose to the date of relapse or progression|Median follow-up time was 100 days; up to the data cut-off of 28 July 2015|ITT includes all participants who received at least one dose of romidepsin||days||95% Confidence Interval|Median
689662|NCT01456039|Secondary|Kaplan Meier Estimate of Time to Progression (TTP) in PTCL Participants Based on the 1999 IWC as Assessed by IER|Time to progression (≥50% increase from the nadir in the individual sum of the products of the diameters of any index lesion; the reappearance of pathology, enlargement of liver/spleen, or unequivocal progression of non-measurable disease or appearance of any new lesions) was defined as the duration from the date of the first study drug dose to the date of relapse or progression|Median follow-up time was 100 days; up to the data cut-off of 28 July 2015|ITT includes all participants who received at least one dose of romidepsin||days||95% Confidence Interval|Median
689663|NCT01456039|Secondary|Kaplan Meier Estimate of Duration of Response (DOR) for PTCL Responders Based on the Modified 2007 IWC as Assessed by the IER.|DOR was defined as the number of days from the date of the first disease response (Complete, Unconfirmed Complete or Partial Response) until the date of progression, analyzed using Kaplan-Meier methods.|Median follow-up time was 100 days; up to the data cut-off of 28 July 2015|Intent to treat population for participants with PTCL who received at least one dose of romidepsin and achieved a PR or better (CR, CRu or PR)||days||95% Confidence Interval|Median
689664|NCT01456039|Secondary|Kaplan Meier Estimate of Duration of Response (DOR) for PTCL Responders Based on the Modified 1999 IWC as Assessed by the IER.|DOR was defined as the number of days from the date of the first disease response (Complete, Unconfirmed Complete or Partial Response) until the date of progression, analyzed using Kaplan-Meier methods.|Median follow-up time was 100 days; up to the data cut-off of 28 July 2015|Intent to treat population for participants with PTCL who received at least one dose of romidepsin and achieved a PR or better (CR, CRu or PR)||days||95% Confidence Interval|Median
689665|NCT01456039|Secondary|Time to Response (TTR) for PTCL Participants With at Least a PR Based on the Modified 2007 IWC as Assessed by IER|TTR for PTCL was defined as the time in days from first dose date to the first date of objective disease response.|Median follow-up time was 100 days; up to the data cut-off of 28 July 2015|Intent to treat population for participants with PTCL who received at least one dose of romidepsin and achieved a PR or better (CR, CRu or PR)||days||Full Range|Median
689666|NCT01456039|Secondary|Time to Response (TTR) for PTCL Participants With at Least a PR Based on the Modified 1999 IWC as Assessed by IER|TTR for PTCL was defined as the time in days from first dose date to the first date of objective disease response.|Median follow-up time was 100 days; up to the data cut-off of 28 July 2015|Intent to treat population for participants with PTCL who received at least one dose of romidepsin and achieved a PR or better (CR, CRu or PR)||days||Full Range|Median
689667|NCT01456039|Secondary|Percentage of PTCL Participants With the Best Response in Accordance With the Modified 2007 International Workshop Response Criteria as Assessed by IER|Objective disease response in PTCL was defined as achieving a CR or PR based on the Modified 2007 IWC. A CR = a complete disappearance of all disease; lymph node mass regression to normal size on computerized tomography (CT) scan or negative on positron emission tomography (PET); non-palpable splenic and disappearance of liver nodules; infiltrate cleared on repeat bone marrow (BM), immunohistochemistry negative. PR = a reduction of measurable lesions; ≥ 50% decrease in sum of the products of the greatest diameters (SPD) of up to 6 largest dominant masses, no enlargement in size of other nodes; ≥ 50% decrease in SPD and no increase in liver or spleen.|Tumor assessments performed every 2 months; median follow-up time was 100 days; up to the data cut-off of 28 July 2015|Intent to treat population for participants with PTCL who received at least one dose of romidepsin||percentage of participants||95% Confidence Interval|Number
689668|NCT01456039|Secondary|The Percentage of Participants With Abnormal Q-wave and T Wave Intervals|The time from the start of the Q-wave to the end of the T-wave QTc intervals greater than 450 msec post-baseline performed by centralized reviewer. The Bazett's (QTcB) and Fridericia (QTcF) correction were used as the standard clinical correction for calculating the heart rate-corrected QTc interval|Median follow-up: 100 days; up to data cut-off of 28 July 2015|The ECG population includes all participants who received romidepsin on Day 1 of Cycle 1 with at least one post-baseline QTc result||percentage of participants|||Number
689669|NCT01456039|Secondary|Cmax Accumulation Ratio of Romidepsin in Phase 1, Cycle 1|Cmax of Romidepsin: accumulation ratio based on Cmax calculated as Cmax,ss/Cmax|Day 1 and Day 15 in Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at end of administration) hours after the start of administration, 0.25, 0.5, 1, 2, 4, 6, 20, and 44 hours after the end of administration. Day 8, Cycle 1, samples collected at 0 hour|PK Population includes of all participants who had sufficient concentration-time data to enable the calculation of PK parameters for at least one PK day. For those who were determined to be noncompliant to receiving romidepsin, or for those with incomplete data, a decision to include the analysis was made on a case-by-case basis.||ratio||Geometric Coefficient of Variation|Geometric Mean
689670|NCT01456039|Secondary|AUC0-t, Accumulation Ratio of Romidepsin in Phase 1, Cycle 1|Area under the plasma concentration-time curve from time zero to the last quantifiable time point; accumulation ratio calculated as AUC (0-t),ss/AUC (0-t)|Day 1 and Day 15 in Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at the end of administration) hours after the start of administration, 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 20, and 44 hours after the end of administration|PK Population includes of all participants who had sufficient concentration-time data to enable the calculation of PK parameters for at least one PK day. For those who were determined to be noncompliant to receiving romidepsin, or for those with incomplete data, a decision to include the analysis was made on a case-by-case basis.||ratio||Geometric Coefficient of Variation|Geometric Mean
689671|NCT01456039|Secondary|Terminal Phase Half-life of Romidepsin (t½) in Phase 1 at Cycle 1, Day 15|The terminal phase half-life of romidepsin after a single dose on Day 15, calculated according to the following equation: t½ = 0.693/λz, where λz is the terminal phase rate constant.|Day 15 at Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at the end of administration) hours after the start of administration, 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 20, and 44 hours after the end of administration.|PK Population includes of all participants who had sufficient concentration-time data to enable the calculation of PK parameters for at least one PK day. For those who were determined to be noncompliant to receiving romidepsin, or for those with incomplete data, a decision to include the analysis was made on a case-by-case basis.||hours||Geometric Coefficient of Variation|Geometric Mean
689672|NCT01456039|Secondary|Tmax,ss of Romidepsin in Phase 1 at Cycle 1, Day 15|Observed time to first maximum plasma concentration at steady state|Day 15 at Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at the end of administration) hours after the start of administration, 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 20, and 44 hours after the end of administration|PK Population includes of all participants who had sufficient concentration-time data to enable the calculation of PK parameters for at least one PK day. For those who were determined to be noncompliant to receiving romidepsin, or for those with incomplete data, a decision to include the analysis was made on a case-by-case basis.||hours||Full Range|Median
689673|NCT01456039|Secondary|Cmax, ss of Romidepsin in Phase 1 at Cycle 1, Day 15|Maximum observed concentration in plasma at steady state|Day 15 at Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at the end of administration) hours after the start of administration, 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 20, and 44 hours after the end of administration|PK Population includes of all participants who had sufficient concentration-time data to enable the calculation of PK parameters for at least one PK day. For those who were determined to be noncompliant to receiving romidepsin, or for those with incomplete data, a decision to include the analysis was made on a case-by-case basis.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
689674|NCT01456039|Secondary|AUC0-t, at Steady State (ss) of Romidepsin in Phase 1 at Cycle 1, Day 15|Area under the plasma concentration-time curve from time zero to the last quantifiable time point at steady state, calculated by the linear trapezoidal rule when concentrations are increasing and the logarithmic trapezoidal method when concentrations are decreasing|Day 15 at Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at the end of administration) hours after the start of administration, 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 20, and 44 hours after the end of administration|PK Population includes of all participants who had sufficient concentration-time data to enable the calculation of PK parameters for at least one PK day. For those who were determined to be noncompliant to receiving romidepsin, or for those with incomplete data, a decision to include the analysis was made on a case-by-case basis.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
689675|NCT01456039|Secondary|Apparent Volume of Distribution (Vz/F) of Romidepsin in Phase 1|Apparent volume of distribution, was calculated according to the equation: Vd/F = (CL/F)/λz|Day 1 at Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at the end of administration) hours after the start of administration, 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 20, and 44 hours after the end of administration|PK Population includes of all participants who had sufficient concentration-time data to enable the calculation of PK parameters for at least one PK day. For those who were determined to be noncompliant to receiving romidepsin, or for those with incomplete data, a decision to include the analysis was made on a case-by-case basis.||Liters||Geometric Coefficient of Variation|Geometric Mean
689676|NCT01456039|Secondary|Apparent Total Clearance of Romidepsin (CL/F) of Romidepsin in Phase 1|The apparent total clearance of romidepsin after a single dose on Day 1, calculated as dose/AUC0-infinity.|Day 1 at Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at the end of administration) hours after the start of administration, 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 20, and 44 hours after the end of administration.|PK population includes of all participants who had sufficient concentration-time data to enable the calculation of PK parameters for at least one PK day. For those who were determined to be noncompliant to receiving romidepsin, or for those with incomplete data, a decision to include the analysis was made on a case-by-case basis.||L/h||Geometric Coefficient of Variation|Geometric Mean
689677|NCT01456039|Secondary|Terminal Phase Half-life of Romidepsin (t½) in Phase 1|The terminal phase half-life of romidepsin after a single dose on Day 1, calculated according to the following equation: t½ = 0.693/λz, where λz is the terminal phase rate constant.|Day 1 at Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at the end of administration) hours after the start of administration, 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 20, and 44 hours after the end of administration.|PK Population includes of all participants who had sufficient concentration-time data to enable the calculation of PK parameters for at least one PK day. For those who were determined to be noncompliant to receiving romidepsin, or for those with incomplete data, a decision to include the analysis was made on a case-by-case basis.||hours||Geometric Coefficient of Variation|Geometric Mean
721030|NCT00317941|Secondary|Percentage of Injection Sites Per Participant With Reaction Reported by Physicians||Up to 3 months|||Percentage of ISR|Participants||Number
689678|NCT01456039|Secondary|Time to Maximum Plasma Concentration of Romidepsin (Tmax) in Phase 1|The time to first maximum observed plasma concentration of romidepsin after a single dose on Day 1.|Day 1 at Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at the end of administration) hours after the start of administration, 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 20, and 44 hours after the end of administration|PK Population includes of all participants who had sufficient concentration-time data to enable the calculation of PK parameters for at least one PK day. For those who were determined to be noncompliant to receiving romidepsin, or for those with incomplete data, a decision to include the analysis was made on a case-by-case basis.||hours||Full Range|Median
689679|NCT01456039|Secondary|Maximum Plasma Concentration (Cmax) of Romidepsin in Phase 1|The maximum observed plasma concentration of romidepsin (Cmax) obtained directly from the observed concentration versus time data|Day 1 at Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at the end of administration) hours after the start of administration, 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 20, and 44 hours after the end of administration|Pharmacokinetic (PK) Population includes of all participants who had sufficient concentration-time data to enable the calculation of PK parameters for at least one PK day. For those who were determined to be noncompliant to receiving romidepsin, or for those with incomplete data, a decision to include the analysis was made on a case-by-case basis.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
689680|NCT01456039|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC∞) of Romidepsin in Phase 1|Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC∞) of romidepsin on Day 1; if possible the area under the concentration-time curve from time zero to infinity, calculated by the linear trapezoidal rule and extrapolated to infinity was calculated according to the following equation: AUC∞ = AUCt + (Ct/ λz ), where Ct is the last quantifiable concentration.|Day 1 at Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at the end of administration) hours after the start of administration, 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 20, and 44 hours after the end of administration|PK Population consisted of all participants who had sufficient concentration-time data to enable the calculation of PK parameters for romidepsin for at least one PK day. For those who were determined to be noncompliant to receiving romidepsin, or for those with incomplete data, a decision to include the analysis was made on a case-by-case basis.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
689681|NCT01456039|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUC0-t) of Romidepsin in Phase 1|Area under the plasma concentration-time curve from time zero to the last quantifiable time point, calculated by the linear trapezoidal rule when concentrations are increasing and the logarithmic trapezoidal method when concentrations are decreasing.|Day 1 at Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at the end of administration) hours after the start of administration, 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 20, and 44 hours after the end of administration|PK Population includes of all participants who had sufficient concentration-time data to enable the calculation of PK parameters for at least one PK day. For those who were determined to be noncompliant to receiving romidepsin, or for those with incomplete data, a decision to include the analysis was made on a case-by-case basis.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
689682|NCT01456039|Secondary|Participants With Treatment-Emergent Adverse Events (TEAEs) Associated With Romidepsin|An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen during the course of a study. An AE that resulted in any of the outcomes was defined as a serious (SAE): • Death • Life-threatening event • An inpatient hospitalization or prolongation of existing hospitalization • Persistent or significant disability or incapacity; • Congenital anomaly or birth defect • Other important medical event The investigator judged the relationship of an AE to study drug based on the timing of the AE relative to drug administration and whether or not other drugs, therapeutic interventions, or underlying conditions could provide an explanation for the event. The severity of an AE was evaluated by the investigator according to Common Terminology Criteria for Adverse Events (CTCAE Version 3.0), Japanese Clinical Oncology Group (JCOG) where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death.|Day 1 of study drug through 30 days after the last dose of study drug or discontinuation date; Up to data cut-off of 28 July 2015; maximum follow up time was 184.3 weeks|Safety population includes all participants who received at least one dose of romidepsin||participants|||Number
689683|NCT01456039|Primary|Percentage of PTCL Participants With an Overall Best Response in Accordance With a Modified International Workshop Response Criteria (IWC) 1999 in Phase 2|Objective disease response in PTCL was defined as patients with a complete response (CR), unconfirmed complete response (CRu) or a partial response (PR) according to modified IWC 1999 criteria and assessed by an independent efficacy reviewer. A CR is >75% decrease in size of maximum 6 largest target within nodal and extranodal lesions, complete disappearance of other nodal and extranodal; total disappearance of clinical disease; disease-related signs and symptoms, normalization of biochemical abnormalities, disappearance of spleen, liver, or kidney enlargement; no bone marrow (BM) involvement, no new sites of disease. CRu: all above criteria fulfilled except for BM involvement is indeterminate. PR: a ≥50% decrease in size of 6 largest target lesions and no increase other nodal and extranodal; no progression of clinical disease; disease-related signs and symptoms, normalization or biochemical abnormalities, no progression in size of liver, spleen, or kidney; and no new sites of disease|Tumor assessments performed every 2 months; median follow-up time was 100 days; up to the data cut-off of 28 July 2015|Intent to treat population for participants with PTCL who received at least one dose of Romidepsin||percentage of participants||95% Confidence Interval|Number
689696|NCT01455545|Secondary|Fraction Exhaled of Nitric Oxide (FeNO) According to Level of Asthma Control.|"Analyze the relation between the level of asthma control according to the Asthma Control Test (ACT) scores and the fraction exhaled of nitric oxide (FeNO). Units FENO: ppb (parts per billion).
Asthma control was measured by Asthma Control Test(ACT). Bad control if ACT score < or = 19 . Good control if ACT score > 19."|4 weeks|The same as primary outcome.||units on a scale (parts per billion)||Inter-Quartile Range|Median
689811|NCT01454791|Primary|Local Injection Site Reaction (0-6) Scale at Baseline, 2 Weeks|patients will complete a daily diary rating their reaction for elements including pain and inflammation or no reaction to all 6 elements listed on the local injection site reaction scale. Range of scores is 0-6 with zero best and 6 worst.|2 weeks|The primary outcome is looking at between-intervention differences at 2 weeks of intervention. Not a comparison at any other timepoint||units on a scale||Standard Deviation|Mean
689684|NCT01456039|Primary|Number of Participants With Dose-limiting Toxicity (DLT) in Accordance With National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 as Determined by the Efficacy and Safety Evaluation Committee (ESEC)|DLT was defined as an adverse event (AE) occurring in Cycle 1 in Phase 1 and judged that the causal relationship to the investigational product could not be denied. The severity of all AEs was graded based upon the NCI CTCAE version 3.0. DLTs were defined as: • Grade 4 Hemoglobin <6.5 g/dL • Grade 4 Neutrophil <500/μL continuing for at least 5 days • Febrile neutropenia (Grade 4 neutropenia caused by fever and ≥ 38.5° C for more than 1 hour) • Grade 4 thrombocyte (< 25,000/μL), or thrombocytopenia with hemorrhage requiring platelet transfusion • Nausea, vomiting, or diarrhea at > grade 3 in spite of treatment • Grade 3 ALT (alanine aminotransferase) or AST (aspartate aminotransferase) values continued for 7 days. • Grade 4 ALT or AST • Grade 2 arrhythmia • Grade 4 non-hematological AEs • Other grade 3 non-hematological AEs except transient fatigue, anorexia, hyponatremia, and tumor lysis syndrome • Other AEs leading to discontinuation of administration|Up to Day 28; Cycle 1|DLT population included all participants in the Phase 1 portion who received at least one dose of romidepsin. Of 8 participants enrolled in the 14mg/m^2 cohort, 2 participants, one with a critical Good Clinical Practice (GCP)violation and the other who did not complete Cycle 1 due to consent withdrawal, were excluded from the DLT assessment.||participants|||Number
689685|NCT01456000|Primary|Number of Participants That Meeting the Efficacy Success Criteria as Described in the Outcome Measure Description|Episodes of AF were monitored during the follow-up period and the rate of participants with no documented, symptomatic episodes of AF in follow-up were be compared. Other efficacy success/failure criteria included acute isolation of all clinically relevant pulmonary veins, lack of ablation-induced left atrial flutter, use of AADs during a follow-up period and left heart ablation or implant for AF in follow-up. Randomized and treated participants that were evaluable for efficacy are reported on for the Outcome Measure.|1 year|||Successful Participants|||Number
689686|NCT01455545|Secondary|Asthma Severity According to Level of Asthma Control.|"Analyze the relation Between the Level of Asthma Control According to the Asthma Control Test (ACT) Score and asthma severity according the Global Initiative for Asthma (GINA).
Asthma control was measured by Asthma Control Test (ACT). Bad control if ACT score < or = 19. Good control if ACT score > 19."|4 months|||participants|||Number
689687|NCT01455545|Secondary|Pulmonary Function Test (Spirometry) According to Level of Asthma Control.|"Analyze the relation between the level of asthma control according to the ACT scores and pulmonary function test (spirometry).
Functional study. The Master Lab system (Jaeger, Wurzburg, Germany) was used to obtain spirometry parameters Respiratory function tests were performed according to the recommendations of the European Respiratory Society. The predicted values used for pulmonary function variables were obtained from the European Community for Coal and Steel. This will be performed according to the recommendations of European Respiratory Society using the Jaeger Master Lab system.
Asthma control was measured by Asthma Control Test (ACT). Bad control if ACT score < or = 19. Good control if ACT score > 19."|4 months|||percentage of the theoretical||Standard Deviation|Mean
689688|NCT01455545|Primary|Analyze How Adherence to Treatment Using Prescription Account Influences Level of Asthma Control.|"Analyze how adherence to treatment using prescription count influences level of asthma control in a sample of patients with severe and moderate-mild asthma. The second primary endpoint analyzes how adherence, using prescription counts, influences the level of asthma control. Good adherence to treatment was defined as a count of prescriptions issued by their family physician greater than 80% of the required treatment during the last 6 months.
Asthma control was measured by Asthma Control Test (ACT). Bad control if ACT score < or = 19 . Good control if ACT score > 19."|4 weeks|||participants|||Number
689689|NCT01455545|Secondary|Concomitant Psychiatric Disorders According to Level of Asthma Control.|"Analyze the relation between the level of asthma control according to the Asthma Control Test (ACT) score and concomitant psychiatric disorders.
Depression and anxiety were the concomitant psychiatric disorders. Asthma control was measured by Asthma Control Test (ACT). Bad control if ACT score < or = 19. Good control if ACT score > 19."|4 weeks|||participants|||Number
689690|NCT01455545|Secondary|Gastroesophageal Reflux According to Level of Asthma Control.|"Analyze the relation Between the Level of Asthma Control According to the ACT Score and gastroesophageal reflux.
Gastroesophageal reflux was diagnosed by symptoms or previous diagnosis in their medical records with or without treatment for reflux.
Asthma control was measured by Asthma Control Test (ACT). Bad control if ACT score < or = 19. Good control if ACT score > 19."|4 weeks|||participants|||Number
689691|NCT01455545|Secondary|Sinusitis According to Level of Asthma Control.|"Analyze the relation between the level of asthma control according to the Asthma Control Test (ACT) Score and Sinusitis.
Asthma control was measured by Asthma Control Test (ACT). Bad control if ACT score < or = 19. Good control if ACT score > 19.
Diagnosis of sinusitis was established according to The European Position Paper on Rhinosinusitis and Nasal Polyps (EP3OS) group."|4 weeks|||participants|||Number
689692|NCT01455545|Secondary|Rhinitis According to Level of Asthma Control.|"Analyze the relation between the level of asthma control according to the Asthma Control Test (ACT) score and rhinitis.
Asthma control was measured by Asthma Control Test (ACT). Good control if ACT score > 19. Bad control if ACT score < or = 19.
Rhinitis was diagnosed by symptoms, according to Allergic Rhinitis and its Impact on Asthma(ARIA)guideline."|4 weeks|||participants|||Number
689693|NCT01455545|Secondary|Obesity According to Level of Asthma Control.|"Analyze the correlation between the level of asthma control according to the Asthma Control Test (ACT) score and obesity, measured by body mass index(BMI). If BMI (18-25) = normal. If BMI (25 - 29) = overweight. If BMI > 30 obesity.
Asthma control was measured by Asthma Control test (ACT). Good control if ACT score > 19. Bad control if ACT score < or = 19 ."|4 weeks|||participants|||Number
689694|NCT01455545|Secondary|Smoking Habit According to Level of Asthma Control.|"Analyze the relation between the level of asthma control according to the Asthma Control Test (ACT) score and smoking habit.
Good control if ACT score > 19. Bad control if ACT score < or = 19. Patients were divided into three types: active smokers, former smokers and people who had never smoked."|4 weeks|||participants|||Number
689695|NCT01455545|Secondary|Gender According to Level of Asthma Control.|"Analyze the relation between the level of asthma control according to the Asthma Control Test (ACT) scores and the gender.
Asthma control was measured by Asthma Control Test(ACT). Good control if ACT score > 19. Bad control if ACT score < or = 19."|4 weeks|||participants|||Number
721031|NCT00317941|Secondary|Percentage of Injection Sites With Pain Reported by Physicians||Up to 3 months|||Percentage of sites|Participants||Number
689697|NCT01455545|Primary|Analyze How Adherence to Treatment Using ASK-20 Questionnaire Influences Level of Asthma Control.|"The ASK-20 (Adherence Starts with Knowledge)is a brief, self-reported instrument developed to identify patient-specific barriers to medication adherence and to improve provider/patient communication about adherence.
Programs incorporating a clinical assessment tool such as the ASK-20 for identifying a broad range of risk factors for nonadherence and for developing patient-specific intervention may reduce adherence barriers and improve disease control and ability to perform daily activities in patients with asthma.
To gauge the overall risk of nonadherence, the total ASK-20 score was calculated,as the sum of the individual item score, ranging from 1 to 5 and therefore total ranges score from 20 (less barriers to adherence) to 100 (more barriers)."|4 weeks|||units on a scale||Inter-Quartile Range|Median
689711|NCT01455428|Secondary|Change From Baseline in HADS Depression Total Score at Endpoint|The HADS was a self-administered questionnaire that consisted of 2 subscales, 1 measuring anxiety (HADS-A Scale) and the other measuring depression (HADS-D Scale). Each subscale was comprised of 7 items; participants assessed how each item applied to them on a scale of 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Subscores from HADS-A (Anxiety) and HADS-D (Depression) were not to be combined. The interpretation of each HADS subscales was as follows: 0-7 normal, 8-10 mild, 11-14 moderate and 15-21 severe.|Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure.||units on a scale||Standard Error|Least Squares Mean
689712|NCT01455428|Secondary|Change From Baseline in HADS Anxiety Total Score at Endpoint|The HADS was a self-administered questionnaire that consisted of 2 subscales, 1 measuring anxiety (HADS-A Scale) and the other measuring depression (HADS-D Scale). Each subscale was comprised of 7 items; participants assessed how each item applied to them on a scale of 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Subscores from HADS-A (Anxiety) and HADS-D (Depression) were not to be combined. The interpretation of each HADS subscales was as follows: 0-7 normal, 8-10 mild, 11-14 moderate and 15-21 severe.|Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure.||units on a scale||Standard Error|Least Squares Mean
722132|NCT00307333|Primary|Number of Ventilator-free Days||120 days|||days||Standard Deviation|Mean
689713|NCT01455428|Secondary|Baseline Hospital Anxiety and Depression Scale (HADS) Scores|The HADS was a self-administered questionnaire that consisted of 2 subscales, 1 measuring anxiety (HADS-A Scale) and the other measuring depression (HADS-D Scale). Each subscale comprised of 7 items; participants assessed how each item applied to them on a scale of 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Subscores from HADS-A (Anxiety) and HADS-D (Depression) were not to be combined. The interpretation of each HADS subscales was as follows: 0-7 normal, 8-10 mild, 11-14 moderate and 15-21 severe.|Baseline|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.||units on a scale||Standard Deviation|Mean
689714|NCT01455428|Secondary|Patient Global Impression of Change (PGIC) Score at Endpoint|The PGIC was a participant-rated global measure that provided a clinically relevant and easy to interpret account of a participant’s perception of the clinical importance of their own improvement or worsening during their involvement in a clinical study. Participants rated their overall improvement on a 7-point scale where scores ranged from 1 (very much improved) to 7 (very much worse).|Day 57 (Week 8)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure.||units on a scale||Standard Error|Least Squares Mean
689715|NCT01455428|Secondary|Clinical Global Impression of Change (CGIC) Score at Endpoint|The CGIC was a clinician-rated global measure that provided a clinically relevant and easy to interpret account of a clinician’s perception of the clinical importance of the participant's improvement or worsening during their involvement in a clinical study. Clinicians rated the participant's overall improvement on a 7-point scale where scores ranged from 1 (very much improved) to 7 (very much worse).|Day 57 (Week 8)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure.||units on a scale||Standard Error|Least Squares Mean
689716|NCT01455428|Secondary|Change From Baseline in MOS-Sleep Scale, Sleep Problems Index Score at Endpoint|The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The sleep problems index subscale score also ranged from 0 to 100, with lower scores indicating fewer sleep problems.|Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure.||units on a scale||Standard Error|Least Squares Mean
689717|NCT01455428|Secondary|Change From Baseline in MOS-Sleep Scale, Somnolence Score at Endpoint|The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The somnolence subscale score also ranged from 0 to 100, with lower scores indicating less somnolence.|Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure.||units on a scale||Standard Error|Least Squares Mean
689718|NCT01455428|Secondary|Change From Baseline in MOS-Sleep Scale, Sleep Adequacy Score at Endpoint|The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The sleep adequacy subscale also ranged from 0 to 100, with higher scores indicating greater sleep adequacy.|Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure.||units on a scale||Standard Error|Least Squares Mean
689719|NCT01455428|Secondary|Percentage of Participants Who Had Optimal Sleep at Endpoint|The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The MOS optimal sleep subscale was a binary outcome derived from the sleep quantity responses: the response was YES if sleep quantity was 7 or 8 hours per night.|Day 57 (Week 8)/Early Termination (Study Endpoint)|All participants in the FAS population (consisted of all participants randomized to treatment that received at least 1 dose of study medication) with available data to contribute to the analysis.||percentage of participants|||Number
689720|NCT01455428|Secondary|Change From Baseline in MOS-Sleep Scale, Quantity of Sleep Score at Endpoint|The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The MOS Sleep Quantity sub-scale scores ranged from 0 to 24 (number of hours slept).|Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure.||units on a scale||Standard Error|Least Squares Mean
689730|NCT01455428|Secondary|Change From Baseline in Weekly Mean Sleep Interference Scores at Weeks 1 to 8|Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]). Participants were to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10. The weekly mean score was the sum of the daily scores divided by the number of diary entries during that week.|Baseline and weekly from Weeks 1 to 8|The FAS population consisted of all participants randomized to treatment that received at least 1 dose of study medication.||units on a scale||Standard Error|Least Squares Mean
689721|NCT01455428|Secondary|Change From Baseline in MOS-Sleep Scale, Awaken Short of Breath Score at Endpoint|The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The awaken short of breath subscale also ranged from 0 to 100, with lower scores indicating less difficulty in breathing.|Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure.||units on a scale||Standard Error|Least Squares Mean
689722|NCT01455428|Secondary|Change From Baseline in MOS-Sleep Scale, Snoring Score at Endpoint|The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The snoring subscale score also ranged from 0 to 100, with lower scores indicating less snoring.|Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure.||units on a scale||Standard Error|Least Squares Mean
689723|NCT01455428|Secondary|Change From Baseline in MOS-Sleep Scale, Sleep Disturbance Score at Endpoint|The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. For sleep disturbance, the subscale score also ranged from 0 to 100, with higher scores representing greater sleep disturbance.|Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure.||units on a scale||Standard Error|Least Squares Mean
689724|NCT01455428|Secondary|Baseline Medical Outcomes Study (MOS)-Sleep Scale Scores|The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. With the exception of sleep adequacy, optimal sleep, and quantity, higher scores reflected greater impairment in the MOS-Sleep subscales. The MOS-Sleep Scale was used to evaluate sleep during the previous week.|Baseline|The FAS population consisted of all participants randomized to treatment that received at least 1 dose of study medication. The LOCF method was used in the analysis of this outcome measure.||units on a scale||Standard Deviation|Mean
689725|NCT01455428|Secondary|Change From Baseline in PPI Scale From the SF-MPQ at Endpoint|The PPI was part of the SF-MPQ scale and measured the participant's present pain intensity on a 6-point scale ranging from 0 (no pain) to 5 (excruciating).|Baseline to Day 57 (Week 8)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.||units on a scale||Standard Error|Least Squares Mean
689726|NCT01455428|Secondary|Change From Baseline in Pain VAS From the SF-MPQ at Endpoint|The VAS was part of the SF-MPQ scale and reflected the overall pain intensity score. The pain VAS was a horizontal line; 100 mm in length, was self-administered by the participant in order to rate pain from 0 (no pain) to 100 (worst possible pain).|Baseline to Day 57 (Week 8)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.||units on a scale||Standard Error|Least Squares Mean
689727|NCT01455428|Secondary|Baseline Pain Visual Analogue Scale (VAS) and Present Pain Intensity (PPI) Scale|The VAS was part of the Short Form McGill Pain Questionnaire (SF-MPQ) scale and reflected the overall pain intensity score, The pain VAS was a horizontal line; 100 millimeters (mm) in length, was self-administered by the participant in order to rate pain from 0 (no pain) to 100 (worst possible pain). The PPI was part of the SF-MPQ scale and measured the participant's present pain intensity on a 6-point scale ranging from 0 (no pain) to 5 (excruciating).|Baseline|The FAS population consisted of all participants randomized to treatment that received at least 1 dose of study medication. The LOCF method was used in the analysis of this outcome measure. Number of participants evaluable for PPI=110, 108||units on a scale||Standard Deviation|Mean
689728|NCT01455428|Secondary|Change From Baseline in Short Form McGill Pain Questionnaire (SF-MPQ) Score at Weeks 1, 3, 5, and 8|SF-MPQ was assessed according to the participant’s answer to the SF-MPQ questionnaire. The score for each composite scale (sensory, affective, and total) was derived by summing the reported intensity value for each item within a particular scale where None=0, Mild=1, Moderate=2, and Severe=3. The sensory score was the sum of the scores of the first 11 pain descriptors (throbbing, shooting, stabbing, sharp, cramping, gnawing, hot-burning, aching, heavy, tender, and splitting) and could range from 0-33. The affective score was the sum of the scores of the last 4 pain descriptors (tiring-exhausting, sickening, fearful, and punishing-cruel) and could range from 0-12. The total score was the sum of the scores of all 15 pain descriptors and could range from 0 to 45. Higher scores indicated greater pain.|Baseline; Weeks 1, 3, 5, and 8|The FAS population consisted of all participants randomized to treatment that received at least 1 dose of study medication. N=the number of participants who were evaluable for this measure at the given time point.||units on a scale||Standard Deviation|Mean
689729|NCT01455428|Secondary|Percentage of 30 Percent (%) Responders at Endpoint|The DPRS consists of an 11-point numeric scale ranging from 0 (“no pain”) to 10 (“worst possible pain”). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. A 30% responder was a participant who had 30% reduction or more in mean pain score at the end of the fixed dose phase (Day 57/Week 8)/Early Termination (Study Endpoint) compared to baseline.|End of fixed dose phase (Day 57/Week 8)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.||percentage of participants|||Number
689731|NCT01455428|Secondary|Change From Baseline in Mean Sleep Interference Score at Endpoint|Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]). Participants were to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10. The mean endpoint score was obtained from the last 7 available scores of the daily diary while the participant was on study medication, up to and including the day after the last Week 8 (Day 57) dose.|Baseline until end of fixed dose phase (Day 57/Week 8)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.||units on a scale||Standard Error|Least Squares Mean
689732|NCT01455428|Secondary|Baseline Mean Sleep Interference Score|Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]). Participants were to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10.|Baseline|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.||units on a scale||Standard Deviation|Mean
689733|NCT01455428|Secondary|Change From Baseline in Weekly Mean Pain Score at Weeks 1 to 8|The DPRS consists of an 11-point numeric scale ranging from 0 (“no pain”) to 10 (“worst possible pain”). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. The weekly mean pain score was the sum of the daily scores divided by the number of diary entries during that week.|Baseline and weekly from Weeks 1 to 8|The FAS population consisted of all participants randomized to treatment that received at least 1 dose of study medication.||units on a scale||Standard Error|Least Squares Mean
689734|NCT01455428|Primary|Change From Baseline in Mean Pain Score at Endpoint|The daily pain rating scale (DPRS) consists of an 11-point numeric scale ranging from 0 (“no pain”) to 10 (“worst possible pain”). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. The mean endpoint pain score was obtained from the last 7 available DPRS scores of the daily pain diary while the participant was on study medication, up to and including the day after the last Week 8 (Day 57) dose.|Baseline until end of fixed dose phase (Day 57/Week 8)/Early Termination (Study Endpoint)|All participants in the Full Analysis Set (FAS) population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The Last Observation Carried Forward (LOCF) method was used.||units on a scale||Standard Error|Least Squares Mean
689735|NCT01455428|Primary|Baseline Mean Pain Score|The daily pain rating scale (DPRS) consists of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10.|Baseline|All participants in the Full Analysis Set (FAS) population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The Last Observation Carried Forward (LOCF) method was used.||units on a scale||Standard Deviation|Mean
689736|NCT01455415|Secondary|PGIC Score at the End of Period 1 (Week 6) - Categorized Scores|The PGIC is a participant-rated instrument that measures the participant`s assessment of change in his/her overall status on a scale ranging from 1 (very much improved) to 7 (very much worse). Original scores (7 different scores) and categorized scores (4 different scores) were provided. Categorized scores were very much improved (consisting of very much improved and much improved); any improvement (consisting of very much improved, much improved, and minimally improved); no change (consisting of no change); and any worsening (consisting of minimally worse, much worse, and very much worse). Due to the crossover design, PGIC was analyzed at the end of period 1 (V5).|End of Period 1 (V5)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period. All participants who were randomized and had a period 1 PGIC value were used for this analysis.||percentage of participants|||Number
689737|NCT01455415|Primary|Average Diabetic Peripheral Neuropathy (DPN) Pain Based on a Numeric Rating Scale (NRS) Over the Last 7 Days of Each Treatment Period (Week 6 of Each Treatment Period)|The daily pain diary consisted of an 11-point numeric scale ranging from 0 (“no pain”) to 10 (“worst possible pain”). Participants described their pain during the past 24 hours by having chosen the appropriate number between 0 and 10. Self assessment was performed daily in the evening before bedtime on a telephone via interactive voice recognition system (IVRS) (time window for completion between 6.00 pm to midnight). The endpoint mean pain score was defined as the mean of the last 7 daily diary pain ratings while taking study drug in each treatment period - period 1 and period 2, respectively. A rating of 1 - 3 was considered as mild pain; 4 - 6 as moderate pain; and 7 - 10 as severe pain.|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.||units on a scale||Standard Error|Least Squares Mean
689738|NCT01455415|Secondary|Patient Global Impression of Change (PGIC) Score at the End of Period 1 (Week 6) - Original Scores|The PGIC is a participant-rated instrument that measures the participant`s assessment of change in his/her overall status on a scale ranging from 1 (very much improved) to 7 (very much worse). Due to the crossover design, PGIC was analyzed at the end of period 1 (V5).|End of Period 1 (V5)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period. All participants who were randomized and had a period 1 PGIC value were used for this analysis.||percentage of participants|||Number
689794|NCT01455012|Secondary|Change From Baseline in the Periodic Limb Movements Index (PLMI) at the End of the 4-week Maintenance Period|The PLMI is defined as Periodic Limb Movements (PLMs)/ total time in bed in hours. PLMs are measured by Polysomnography (PSG). A negative value in PLMI Change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|Baseline to the end of the 4-week Maintenance Period|Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure.||Periodic Limb Movements/hour||Standard Deviation|Mean
689739|NCT01455415|Secondary|EQ-5D Dolan 2002 Index Summary Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|EQ-5D is a participant-completed 5-item questionnaire designed to assess health related quality of life in terms of a single index value or utility score. There are 5 dimensions: mobility, self-care, usual activities, pain / discomfort, and anxiety / depression. Each dimension is rated on a 3-point response scale [1 = no problems, 2 = some/moderate problems, 3 = extreme problems] and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health. The utility score is calculated using the Dolan 1997 algorithm and the revised version which was provided to the EuroQol Group by Dolan in 2001 – but later published in medical care in 2002.|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.||units on a scale||Standard Error|Least Squares Mean
689740|NCT01455415|Secondary|EQ-5D Dolan 1997 Index Summary Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|EQ-5D is a participant-completed 5-item questionnaire designed to assess health related quality of life in terms of a single index value or utility score. There are 5 dimensions: mobility, self-care, usual activities, pain / discomfort, and anxiety / depression. Each dimension is rated on a 3-point response scale [1 = no problems, 2 = some/moderate problems, 3 = extreme problems] and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health. The utility score is calculated using the Dolan 1997 algorithm and the revised version which was provided to the EuroQol Group by Dolan in 2001 – but later published in medical care in 2002.|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.||units on a scale||Standard Error|Least Squares Mean
689741|NCT01455415|Secondary|EQ-5D Anxiety / Depression Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|EQ-5D is a participant-completed 5-item questionnaire designed to assess health related quality of life in terms of a single index value or utility score. There are 5 dimensions: mobility, self-care, usual activities, pain / discomfort, and anxiety / depression. Each dimension is rated on a 3-point response scale [1 = no problems, 2 = some/moderate problems, 3 = extreme problems] and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health.|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.||units on a scale||Standard Error|Least Squares Mean
689742|NCT01455415|Secondary|EQ-5D Pain / Discomfort Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|EQ-5D is a participant-completed 5-item questionnaire designed to assess health related quality of life in terms of a single index value or utility score. There are 5 dimensions: mobility, self-care, usual activities, pain / discomfort, and anxiety / depression. Each dimension is rated on a 3-point response scale [1 = no problems, 2 = some/moderate problems, 3 = extreme problems] and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health.|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.||units on a scale||Standard Error|Least Squares Mean
689743|NCT01455415|Secondary|EQ-5D Usual Activities Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|EQ-5D is a participant-completed 5-item questionnaire designed to assess health related quality of life in terms of a single index value or utility score. There are 5 dimensions: mobility, self-care, usual activities, pain / discomfort, and anxiety / depression. Each dimension is rated on a 3-point response scale [1 = no problems, 2 = some/moderate problems, 3 = extreme problems] and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health.|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.||units on a scale||Standard Error|Least Squares Mean
689744|NCT01455415|Secondary|EQ-5D Self-Care Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|EQ-5D is a participant-completed 5-item questionnaire designed to assess health related quality of life in terms of a single index value or utility score. There are 5 dimensions: mobility, self-care, usual activities, pain / discomfort, and anxiety / depression. Each dimension is rated on a 3-point response scale [1 = no problems, 2 = some/moderate problems, 3 = extreme problems] and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health.|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.||units on a scale||Standard Error|Least Squares Mean
689745|NCT01455415|Secondary|Euro QoL-5 Dimensions (EQ-5D) Mobility Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|EQ-5D is a participant-completed 5-item questionnaire designed to assess health related quality of life in terms of a single index value or utility score. There are 5 dimensions: mobility, self-care, usual activities, pain / discomfort, and anxiety / depression. Each dimension is rated on a 3-point response scale (no problems, some/moderate problems, extreme problems) and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health.|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.||units on a scale||Standard Error|Least Squares Mean
689803|NCT01454830|Secondary|Proportion of Participants Who Withdrawal|Feasibility assessment - withdrawal by participants for feasibility outcome of pilot RCT|Duration of protocol period|Considers only participant withdrawals requested from study||percentage of participants|||Number
690137|NCT01451398|Secondary|Severe Hypoglycemia Event Rate|Number of Severe Hypoglycemic Events/Total Subject Exposure Time (in months)|Baseline to Week 24|Safety population||Events/100 Subject-Month|||Number
725191|NCT00351273|Secondary|Enthesitis (Presence or Absence of Plantar Fasciitis or Achilles Tendonitis)||Months 6 and 9||||||
689746|NCT01455415|Secondary|Norfolk QOL-DN Autonomic Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess the impact of diabetic neuropathy on quality of life of participants with diabetic neuropathy. The items are scored according to the 5-point Likert Scale (0 - 4, “no problem” to “severe problem”). The autonomic domain score should be summed as follow: Σ (19, 20, 21). The scales and subscales are calculated without weighting of any kind, and reported as the integer sum of the listed questionnaire items (range: 0 - 12). The QOL-DN version that was administered in this study was modified with a 2-week recall period.|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.||units on a scale||Standard Error|Least Squares Mean
689747|NCT01455415|Secondary|Norfolk QOL-DN Small Fiber Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|"Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on quality of life of participants with diabetic neuropathy. The items are scored according to the 5-point Likert Scale (0 - 4, no problem to severe problem). The small fiber domain score should be summed as follow: Σ (10, 16, 17, 18). Scales and subscales are calculated without weighting of any kind, and reported as integer sum of the listed questionnaire items (range: 0 - 16). The QOL-DN version that was administered in this study was modified with a 2-week recall period."|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.||units on a scale||Standard Error|Least Squares Mean
689748|NCT01455415|Secondary|Norfolk QOL-DN Physical Functioning / Large Fiber Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|"Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess the impact of diabetic neuropathy on quality of life of participants with diabetic neuropathy. With exception of questions 31 and 32, items are scored according to the 5-point Likert Scale (0 - 4, “no problem” to “severe problem”). In question 31, “good”, middle item, is scored as 0, “very good” as -1 , “excellent” as -2, “fair” as 1, and “poor” as 2. In question 32, “about the same”, middle item, is scored as 0, somewhat better as -1, much better as -2, somewhat worse as 1, and much worse as 2. Physical functioning / large fiber domain score should be summed as follow: Σ (8, 11, 13 - 15, 24, 27 - 35). Scales and subscales are calculated without weighting of any kind, and reported as integer sum of listed questionnaire items (range: -4 - 56). QOL-DN version that was administered in the study was modified with a 2-week recall period."|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.||units on a scale||Standard Error|Least Squares Mean
689749|NCT01455415|Secondary|Norfolk QOL-DN Activities of Daily Living Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess the impact of diabetic neuropathy on quality of life of participants with diabetic neuropathy. The items are scored according to the 5-point Likert Scale (0 - 4, “no problem” to “severe problem”). Activities of the daily living domain score should be summed as follow: Σ (12, 22, 23, 25, 26). Scales and subscales are calculated without weighting of any kind, and reported as integer sum of listed questionnaire items (range: 0 - 20). The QOL-DN version that was administered in the study was modified with a 2-week recall period.|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.||units on a scale||Standard Error|Least Squares Mean
689750|NCT01455415|Secondary|Norfolk QOL-DN Symptoms Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|"Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess the impact of diabetic neuropathy on quality of life of participants with diabetic neuropathy. All symptoms (1 - 7) are scored as either 1 or 0, indicating presence or absence of the symptom. Item 9 is scored according to the 5-point Likert Scale (0 - 4, no problem to severe problem). The symptoms domain score should be summed as follow: Σ (1 - 7, 9). The scales and subscales are calculated without weighting of any kind, and reported as the integer sum of the listed questionnaire items (range: 0 - 32). The QOL-DN version that was administered in this study was modified with a 2-week recall period."|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.||units on a scale||Standard Error|Least Squares Mean
689751|NCT01455415|Secondary|Norfolk Quality of Life-Diabetic Neuropathy (Norfolk QOL-DN) Total Quality of Life (TQOL) Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|"Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on quality of life of participants with diabetic neuropathy. All symptoms (1 - 7) are scored as either 1 or 0, indicating presence or absence of the symptom. With exception of questions 31 and 32, the other items are scored according to the 5-point Likert Scale (0 - 4, “no problem” to “severe problem”). In question 31, “good”, the middle item, is scored as 0, “very good” as -1, “excellent” as -2, “fair” as 1, and “poor” as 2. In question 32, “about the same”, the middle item, is scored as 0, somewhat better as -1, much better as -2, somewhat worse as 1, and much worse as 2. TQOL score should be summed as follow: sum (Σ) (1 - 7, 8 - 35). The (sub)scales are calculated without weighting of any kind, and reported as the integer sum of listed questionnaire items (range: -4 - 136). The QOL-DN version that was administered in this study was modified with a 2-week recall period."|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.||units on a scale||Standard Error|Least Squares Mean
689804|NCT01454830|Secondary|Proportion of Participants Who Complete Protocol After Allocation|Feasibility assessment - retention after enrollment and allocation employed as a feasibility outcome of pilot RCT|Duration of protocol period|Considers only participant withdrawals, administrative withdrawals for incomplete protocol procedures due to attrition; does NOT include excluded by a priori determined exclusion criteria for protocol||percentage of participants|||Number
689752|NCT01455415|Secondary|HADS-D Total Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|HADS is a 14- item self-administered questionnaire that consists of 2 scales, one measuring anxiety (HADS-A), and the other measuring depression (HADS-D). Each subscale consists of 7 statements and the participant responds as to how each item applies to him/her over the past week on 4- point response scale. Separate scores are calculated for anxiety and depression and a score (ranging from 0 to 21) is obtained for each subscale. The higher the score, the more severe the anxiety or depression.|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.||units on a scale||Standard Error|Least Squares Mean
689753|NCT01455415|Secondary|Hospital Anxiety and Depression Scale - Anxiety (HADS-A) Total Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|The Hospital Anxiety and Depression Scale (HADS) is a 14- item self-administered questionnaire that consists of 2 scales, one measuring anxiety (HADS-A), and the other measuring depression (HADS-D). Each subscale consists of 7 statements and the participant responds as to how each item applies to him/her over the past week on 4- point response scale. Separate scores are calculated for anxiety and depression and a score (ranging from 0 to 21) is obtained for each subscale. The higher the score, the more severe the anxiety or depression.|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.||units on a scale||Standard Error|Least Squares Mean
689754|NCT01455415|Secondary|Mean Sleep Interference Rating Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|The daily sleep diary consists of an 11-point numeric rating scale with which the participant rates how painful DPN pain has interfered with their sleep during the past 24 hours. Zero indicates “does not interfere with sleep” and 10 indicates “completely interferes (unable to sleep due to pain)”. Self assessment was performed daily in the evening before bedtime on a telephone via IVRS (time window for completion between 6.00 pm to midnight) after completion of the daily pain diary.|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.||units on a scale||Standard Error|Least Squares Mean
689755|NCT01455415|Secondary|BPI-sf Score for Pain-Interference Domain at the End of Each Treatment Period (Week 6 of Each Treatment Period)|The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. Seven sub-questions evaluates the level of interference of pain on daily functioning (general activity, walking, work ability, mood, enjoyment of life, relations with other people, and sleep) on an 11-point scale (0: does not interfere; 10: completely interferes). Scores range from 0 - 10 with higher scores indicating greater interference.|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.||units on a scale||Standard Error|Least Squares Mean
689756|NCT01455415|Secondary|Brief Pain Inventory-Short Form (BPI-sf) Score for Pain-Severity Domain at the End of Each Treatment Period (Week 6 of Each Treatment Period)|The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. Four items measure pain (0: no pain; 10: worst pain possible) at its “worst, “least”, “average”, and “now” (current pain) on an 11-point scale. Scores range from 0 - 10 with higher scores indicating greater pain severity.|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.||units on a scale||Standard Error|Least Squares Mean
689757|NCT01455415|Secondary|Percentage of Participants Achieving 50% Reduction in Mean DPN Pain Score From Baseline at the End of Each Treatment Period (Week 6 of Each Treatment Period)|Daily pain diary consisted of an 11-point numeric scale ranging from 0 (“no pain”) to 10 (“worst possible pain”). Participants described their pain during the past 24 hours by having chosen the appropriate number between 0 and 10. Self assessment was performed daily in the evening before bedtime on a telephone via IVRS (time window for completion between 6.00 pm to midnight). The endpoint mean pain score was defined as the mean of the last 7 daily diary pain ratings while taking study drug in each treatment period - period 1 and period 2, respectively. A rating of 1 - 3 was considered as mild pain; 4 - 6 as moderate pain; and 7 - 10 as severe pain.|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.||percentage of participants|||Number
689758|NCT01455415|Secondary|Percentage of Participants Achieving 30% Reduction in Mean DPN Pain Score From Baseline at the End of Each Treatment Period (Week 6 of Each Treatment Period)|Daily pain diary consisted of an 11-point numeric scale ranging from 0 (“no pain”) to 10 (“worst possible pain”). Participants described their pain during the past 24 hours by having chosen the appropriate number between 0 and 10. Self assessment was performed daily in the evening before bedtime on a telephone via IVRS (time window for completion between 6.00 pm to midnight). The endpoint mean pain score was defined as the mean of the last 7 daily diary pain ratings while taking study drug in each treatment period - period 1 and period 2, respectively. A rating of 1 - 3 was considered as mild pain; 4 - 6 as moderate pain; and 7 - 10 as severe pain.|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.||percentage of participants|||Number
689805|NCT01454830|Secondary|Proportion of Sleep Time on CPAP|% of Total Sleep Time (TST) using CPAP|1 week|Randomized participants with complete primary outcome data and secondary outcome data (total sleep time) measured by concurrent wrist actigraphy during first week of PAP treatment||percentage of TST on PAP||Standard Deviation|Mean
689806|NCT01454830|Primary|Nightly CPAP Use|Mean CPAP use, hrs/night|3 months|||hours/night||Standard Deviation|Mean
689807|NCT01454830|Primary|Nightly CPAP Use|Mean CPAP use, hrs/night|1 month|||hours/night||Standard Deviation|Mean
689759|NCT01455220|Secondary|Quality of Life (as Measured by the Multiple Sclerosis Quality of Life (MSQOL-54))|Change in score on the Multiple Sclerosis Quality of Life (MSQOL-54) from end of study compared to baseline. The MSQOL-54 is a 54-item quality of life questionnaire that has general, as well as, MS specific questions covered in 6 sub-categories (mobility, symptoms, emotional well-being, general contentment, thinking and fatigue, family/social well-being). Minimum score of 0 to maximum score of 100. Overall quality of life is calculated by averaging question 53 and 54. The sub-scales( mental and physical health) are on a weighted scale. Sets of questions are totaled and divided by the number of questions in each section then that section total is multiplied by a weighted value. Then all weighted values are summed for all relevant question sections for that subscale to compute a composite score for both mental health and physical health. A higher score, indicates a higher perceived quality of life for the patient. A lower scorer indicates poorer quality of life impacted by MS.|Baseline, 6 months|||units on a scale||Standard Deviation|Mean
689760|NCT01455220|Secondary|Health Related Quality of Life (as Measured by the Functional Assessment of MS (FAMS))|Change in score on the Functional Assessment of MS (FAMS) questionnaire.The FAMS consists of 44 scored items in six quality-of-life domains: Mobility (seven items), Symptoms (seven items), Emotional well being (seven items), General contentment (seven items), Thinking/fatigue (nine items), and Family/social well being (seven items). Minimum score of 0 to max score of 176. A higher scores indicates positive (better) functional health related quality.|Baseline, 6 months|||units on a scale||Standard Deviation|Mean
689761|NCT01455220|Secondary|Sexual Function (as Measured by the Multiple Sclerosis Quality of Life (MSQOL-54))|Change in composite score in the sexual function subscale of the Multiple Sclerosis Quality of Life (MSQOL-54) over 6 months of Natalizumab treatment. Minimum score of 0 and max score of 100. A higher score indicates a more positive outcome (less sexual dysfunction).|Baseline, 6 months|||units on a scale||Standard Deviation|Mean
689762|NCT01455220|Primary|Sexual Dysfunction (as Measured by the Multiple Sclerosis Intimacy and Sexuality Questionnaire (MSISQ-19) )|Change in level of dysfunction demonstrated by the comparison and analysis of Multiple Sclerosis Intimacy and Sexuality Questionnaire (MSISQ-19) responses at end of study to baseline. Minimum score of 19 to maximum score of 95, the higher score indicates a greater level of sexual dysfunction. Primary subscale (min 5 to max 25), Secondary subscale (min 9 to max 45), tertiary subscale (min 5 to max 25), subscale scores are summed for overall total score.|Baseline, 6 months|||units on a scale||Standard Deviation|Mean
689763|NCT01455194|Secondary|Number of Participants With Markedly Abnormal Laboratory Values|The number of participants with any markedly abnormal standard safety laboratory values collected throughout study. Baseline of double-blind treatment period was defined as the average of the measurements of the last 2 weeks at site prior to first intake of double-blind study medication.|Baseline period (Week -3 up to -1), treatment period (Baseline up to Week 56)|Safety analysis set included all participants who took at least 1 dose of study medication.One participant erroneously randomized into 160 mcg arm, actually received 640 mcg dose.For safety analysis, participants were analyzed based on the treatment they actually received.||participants|||Number
689764|NCT01455194|Secondary|Number of Participants Reporting Clinically Significant Change From Baseline in Physical Examination Findings|Physical examination consists of examinations of the following body systems: (1) eyes; (2) ears, nose, throat; (3) cardiovascular system; (4) respiratory system; (5) gastrointestinal system; (6) dermatologic system; (7) extremities; (8) musculoskeletal system; (9) nervous system; (10) lymph nodes; and (11) physical examinations other than body systems described in (1) to (10). Baseline of double-blind treatment period was defined as the average of the measurements of the last 2 weeks at site prior to first intake of double-blind study medication.|Baseline period (Week -3 up to -1), treatment period (Baseline up to Week 56)|Safety analysis set included all participants who took at least 1 dose of study medication.One participant erroneously randomized into 160 mcg arm, actually received 640 mcg dose.For safety analysis, participants were analyzed based on the treatment they actually received.||participants|||Number
689765|NCT01455194|Secondary|Number of Participants Reporting Clinically Significant Change From Baseline in Vital Signs|Vital signs included body temperature, blood pressure (BP) and pulse rate. Normal range for vital signs included: Systolic BP >170 millimeters of mercury (mm Hg) or <85 mm Hg, Diastolic BP >105 mm Hg, resting pulse rate: >120 bpm or <50 bpm, difference in systolic BP at Visit x (increase or decrease) compared with pretreatment >40 mm Hg and difference in pulse rate at Visit x (increase or decrease) compared with pretreatment >30 bpm. Baseline of double-blind treatment period was defined as the average of the measurements of the last 2 weeks at site prior to first intake of double-blind study medication.|Baseline period (Week -3 up to -1), treatment period (Baseline up to Week 56)|Safety analysis set included all participants who took at least 1 dose of study medication.One participant erroneously randomized into 160 mcg arm, actually received 640 mcg dose.For safety analysis, participants were analyzed based on the treatment they actually received.||participants|||Number
689766|NCT01455194|Secondary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. TEAE is defined as an adverse event with an onset that occurs after receiving study drug. AEs included both serious AEs and non-serious AEs. Baseline of double-blind treatment period was defined as the average of the measurements of the last 2 weeks at site prior to first intake of double-blind study medication.|Baseline period (Week -3 up to -1), treatment period (Baseline up to Week 56)|Safety analysis set included all participants who took at least 1 dose of study medication.One participant erroneously randomized into 160 mcg arm, actually received 640 mcg dose.For safety analysis, participants were analyzed based on the treatment they actually received.||participants|||Number
689808|NCT01454830|Primary|Nightly CPAP Use|Mean CPAP use, hrs/night|1 week|||hours/night||Standard Deviation|Mean
689809|NCT01454791|Secondary|Subject Global Impression at 2 Weeks|"This is a single question: How would you rate your level of comfort with Copaxone injection during the past two weeks? Responses include Extremely good, Quite good, Better than average, Average, Below Average, Quite bad, Extremely bad."|2 weeks|The secondary outcome is looking at between-intervention differences at 2 weeks of intervention. Not a comparison at any other timepoint||Likert scale 1-7 (7= best)||Standard Deviation|Mean
725192|NCT00351273|Secondary|Dactylitis||Months 6 and 9||||||
689767|NCT01455194|Secondary|Number of Participants With Markedly High Benefits|The analyses was intended to identify participant’s subsets that would benefit from dose escalation. This analysis tested the potential factors, including age, sex, pretrial inhaled corticosteroid (ICS) dose category, history of exacerbations, baseline ACQ score, baseline BMI category and smoking status. ACQ includes 5 questions about symptoms, 1 about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled).Mean scores of =<0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score >=1.5 indicates uncontrolled asthma. As predefined in the protocol, participants with missing data for any category were not included.|Week 1 up to Week 52|Safety analysis set included all participants who took at least 1 dose of study medication.One participant erroneously randomized into 160 mcg arm, actually received 640 mcg dose.For safety analysis, participants were analyzed based on the treatment they actually received.||participants|||Number
689768|NCT01455194|Secondary|Number of Participants Reporting Asthma Exacerbations Rates|Participants with at least 1 asthma exacerbation in the double-blind treatment period have been reported. As predefined in the protocol, the results for participants with missing data for any category were not included.|Baseline up to Week 52 (treatment period)|The ITT analysis set included participants having at least 1 postrandomization efficacy assessment.This outcome measure was planned to be analyzed on for the treatment period.||participants|||Number
689769|NCT01455194|Secondary|Number of Participants Reporting Time to First Asthma Exacerbation|Asthma exacerbations were defined as a worsening of asthma requiring either treatment with oral (or other systemic) glucocorticosteroids for at least 3 days or hospitalisation or a visit to the emergency room because of asthma. Baseline was defined as the average of the ACQ measurements of the last 2 weeks at site prior to first intake of double-blind study medication|Baseline up to Week 52 (treatment period)|The ITT analysis set included participants having at least 1 postrandomization efficacy assessment.This outcome measure was planned to be analyzed on for the treatment period.||participants|||Number
689770|NCT01455194|Secondary|Number of Participants Reporting Time to First Well-Controlled Asthma Measurement by ACQ Cut-Off Point|Well-controlled asthma was defined as an ACQ score of equal to or lower than the ACQ cut-off point.The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =<0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score >= 1.5 indicates uncontrolled asthma.|Baseline up to Week 52 (treatment period)|The ITT analysis set included participants having at least 1 postrandomization efficacy assessment.This outcome measure was planned to be analyzed on for the treatment period.||participants|||Number
689771|NCT01455194|Secondary|Number of Participants Reporting Time to First Well-Controlled Asthma and ACQ Improvement|Well-controlled asthma at the end of the study was defined as a participant with an ACQ score of 0.75 or lower. ACQ improvement was defined as a decrease in ACQ score of at least 0.5. The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =<0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score >= 1.5 indicates uncontrolled asthma.|Baseline up to Week 52 (treatment period)|The ITT analysis set included participants having at least 1 postrandomization efficacy assessment.This outcome measure was planned to be analyzed on for the treatment period.||participants|||Number
689772|NCT01455194|Secondary|Number of Participants With Well-controlled Asthma and ACQ Improvement at the End of the Study|Well-controlled asthma at the end of the study was defined as a participant with an ACQ score of 0.75 or lower. ACQ improvement was defined as a decrease in ACQ score of at least 0.5. The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =<0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score >= 1.5 indicates uncontrolled asthma.|Week 52|The intent-to-treat ITT analysis set included participants having at least 1 postrandomization efficacy assessment.This outcome measure was planned to be analyzed on for the treatment period.||participants|||Number
689773|NCT01455194|Secondary|Number of Weeks With Well-controlled Asthma Over the Course of the Study|The number of weeks with well-controlled asthma is defined as the number of weeks that the participant had an ACQ score of 0.75 or lower over the course of the study. The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =<0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score >= 1.5 indicates uncontrolled asthma.|Baseline up to Week 52 (treatment period)|The intent-to-treat ITT analysis set included participants having at least 1 postrandomization efficacy assessment.This outcome measure was planned to be analyzed on for the treatment period.||weeks|weeks||Number
689810|NCT01454791|Primary|Pain Scale at 2 Weeks|0-10 subjective Likert scale for severity of injection site reaction associated pain. Zero is best and 10 is worst|2 weeks|The primary outcome is looking at between-intervention differences at 2 weeks of intervention. Not a comparison at any other timepoint||units on a scale||Standard Deviation|Mean
689774|NCT01455194|Secondary|Time Course of ACQ|The time course of the incidence of a 0.5 points improvement of ACQ score was evaluated. Mean ACQ values over time by treatment group for on-treatment site measurements was assessed. The time course of asthma control (ACQ) was done on a weekly base using home-based and site-based ACQ measurements. The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =<0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score >= 1.5 indicates uncontrolled asthma.|Baseline, Week 52 (Treatment period)|The ITT analysis set included participants having at least 1 postrandomization efficacy assessment.This outcome measure was planned to be analyzed on for the treatment period.||Weeks||Full Range|Median
689775|NCT01455194|Primary|Change From Baseline in ACQ Score to Tlast|The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =<0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score >= 1.5 indicates uncontrolled asthma.|Week 52|The ITT analysis set included participants having at least 1 postrandomization efficacy assessment.This outcome measure was planned to be analyzed on for the treatment period.||units on a scale||Standard Error|Mean
689776|NCT01455194|Primary|Asthma Control Questionnaire (ACQ) Score at Baseline|The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =<0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score >= 1.5 indicates uncontrolled asthma.|Baseline|The intent-to-treat (ITT) analysis set included participants having at least 1 postrandomization efficacy assessment.This outcome measure was planned to be analyzed on for the treatment period.||units on a scale||Standard Error|Mean
689777|NCT01455181|Secondary|Mean Change From Baseline in 24-hour Urine Calcium Excretion||24 Weeks|The Intent-to-treat population, which includes all subjects who received at least one dose of study drug and had at least one efficacy measurement.||mg/24 hour||Standard Deviation|Mean
689778|NCT01455181|Secondary|Proportion of Patients Achieving the Primary Endpoint at Each Visit|A ≥ 50% reduction from baseline in dose of oral calcium or an oral calcium dose of ≤ 500 mg and a ≥ 50% reduction from baseline in dose of oral active vitamin D (calcitriol dose of ≤ 0.25 μg/day or alphacalcidol dose of ≤ 0.50 μg/day) and a total serum calcium concentration that was normalized or maintained compared to the baseline value and did not exceed the ULN of the central laboratory.|24 Weeks|The Intent-to-treat population, which includes all subjects who received at least one dose of study drug and had at least one efficacy measurement .||percentage of participants|||Number
689779|NCT01455181|Secondary|Mean Percentage Changes From Baseline in Oral Calcium at Each Visit||24 Weeks|The Intent-to-treat population, which includes all subjects who received at least one dose of study drug and had at least one efficacy measurement.||percentage of change||Standard Deviation|Mean
689780|NCT01455181|Secondary|Mean Percentage Changes From Baseline in Active Vitamin D Dosages at Each Visit||24 Weeks|||percentage of change||Standard Deviation|Mean
689781|NCT01455181|Primary|Percentage of Subjects Who Achieved the Primary Triple Endpoint at Week 24, Based on Investigator Prescribed Data.|A ≥ 50% reduction from baseline in dose of oral calcium or an oral calcium dose of ≤ 500 mg and a ≥ 50% reduction from baseline in dose of oral active vitamin D (calcitriol dose of ≤ 0.25 μg/day or alphacalcidol dose of ≤ 0.50 μg/day) and a total serum calcium concentration that was normalized or maintained compared to the baseline value and did not exceed the ULN of the central laboratory.|24 Weeks|||percentage of participants||95% Confidence Interval|Number
689782|NCT01455064|Primary|Clarke Error Grid Analysis|Percentage of CGM results in the clinically accurate Zone A and percentage of CGM results in the clinically acceptable Zones A and B of the Clarke Error Grid versus blood glucose reference.|15 days sensor wear|One subject was withdrawn due to a mild reaction to the sensor adhesive. This subject's data was included in the study up to the point of withdrawal.||Percentage of Results|Participants||Number
689783|NCT01455012|Secondary|Change From Baseline in Restless Legs Syndrome-6 Rating Scales (RLS-6) Item 6 at the End of the 4-week Maintenance Period|The RLS-6 consists of 6 items of which four items are designed to assess severity of RLS and two items cover sleep and daytime tiredness. Item 6 measures subject's tiredness or sleepiness during the day on a 11-point scale that ranges between 0 (not at all) to 10 (very severe). The ratings are given by the subjects. A negative value in RLS-6 Item 6 Change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|Baseline to the end of the 4-week Maintenance Period|Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure.||units on a scale||Standard Deviation|Mean
689784|NCT01455012|Secondary|Change From Baseline in Restless Legs Syndrome-6 Rating Scales (RLS-6) Item 5 at the End of the 4-week Maintenance Period|The RLS-6 consists of 6 items of which four items are designed to assess severity of RLS and two items cover sleep and daytime tiredness. Item 5 measures the severity of RLS during day not rest on a 11-point scale that ranges between 0 (none) to 10 (very severe). The ratings are given by the subjects. A negative value in RLS-6 Item 5 Change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|Baseline to the end of the 4-week Maintenance Period|Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure.||units on a scale||Standard Deviation|Mean
729867|NCT00383786|Secondary|Able to Identify Biological Markers That Predict Response to Treatment.||10 weeks||||||
689785|NCT01455012|Secondary|Change From Baseline in Restless Legs Syndrome-6 Rating Scales (RLS-6) Item 4 at the End of the 4-week Maintenance Period|The RLS-6 consists of 6 items of which four items are designed to assess severity of RLS and two items cover sleep and daytime tiredness. Item 4 measures the severity of RLS during day rest on a 11-point scale that ranges between 0 (none) to 10 (very severe). The ratings are given by the subjects. A negative value in RLS-6 Item 4 Change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|Baseline to the end of the 4-week Maintenance Period|Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure.||units on a scale||Standard Deviation|Mean
689786|NCT01455012|Secondary|Change From Baseline in Restless Legs Syndrome-6 Rating Scales (RLS-6) Item 3 at the End of the 4-week Maintenance Period|The RLS-6 consists of 6 items of which four items are designed to assess severity of RLS and two items cover sleep and daytime tiredness. Item 3 measures the severity of RLS during the night on a 11-point scale that ranges between 0 (none) to 10 (very severe). The ratings are given by the subjects. A negative value in RLS-6 Item 3 Change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|Baseline to the end of the 4-week Maintenance Period|Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure.||units on a scale||Standard Deviation|Mean
689787|NCT01455012|Secondary|Change From Baseline in Restless Legs Syndrome-6 Rating Scales (RLS-6) Item 2 at the End of the 4-week Maintenance Period|The RLS-6 consists of 6 items of which four items are designed to assess severity of RLS and two items cover sleep and daytime tiredness. Item 2 measures the severity of RLS at time falling asleep on a 11-point scale that ranges between 0 (none) to 10 (very severe). The ratings are given by the subjects. A negative value in RLS-6 Item 2 Change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|Baseline to the end of the 4-week Maintenance Period|Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure.||units on a scale||Standard Deviation|Mean
689788|NCT01455012|Secondary|Change From Baseline in Restless Legs Syndrome-6 Rating Scales (RLS-6) Item 1 at the End of the 4-week Maintenance Period|The RLS-6 consists of 6 items of which four items are designed to assess severity of RLS and two items cover sleep and daytime tiredness. Item 1 measures subject's satisfaction with sleep on a 11-point scale that ranges between 0 (completely satisfied) to 10 (completely dissatisfied). The ratings are given by the subjects. A negative value in RLS-6 Item 6 Change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|Baseline to the end of the 4-week Maintenance Period|Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure.||units on a scale||Standard Deviation|Mean
689789|NCT01455012|Secondary|Clinical Global Impressions (CGI) Item 3 (Therapeutic Efficacy) at the End of the 4-week Maintenance Period|"The CGI Item 3 score measures the therapeutic efficacy on a 4-point scale consisting of the following categories:
1- Very good
2- Moderate
3- Slight
4- Unchanged or worse"|At the end of the 4-week Maintenance Period|Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure.||participants|||Number
689790|NCT01455012|Secondary|Clinical Global Impressions (CGI) Item 1 (Severity of Illness) at the End of the 4-week Maintenance Period|"The CGI Item 1 score measures the severity of illness on a 7-point scale consisting of the following categories:
1- Normal, not ill at all
2- Borderline ill
3- Mildly ill
4- Moderately ill
5- Markedly ill
6- Severely ill
7- Among the most extremely ill subjects"|At the end of the 4-week Maintenance Period|Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure.||participants|||Number
689791|NCT01455012|Secondary|Clinical Global Impressions (CGI) Item 2 (Change of Condition) at the End of the 4-week Maintenance Period|"The CGI Item 2 score measures any change in severity of RLS from Baseline on a 7-point scale consisting of the following categories:
1- Very much improved
2- Much improved
3- Minimally improved
4- No change
5- Minimally worse
6- Much worse
7- Very much worse"|At the end of the 4-week Maintenance Period|Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure.||participants|||Number
689792|NCT01455012|Secondary|Change From Baseline in Restless Legs Syndrome-Quality of Life (RLS-QoL) at the End of the 4-week Maintenance Period|The RLS-QoL is a disease-specific instrument for the evaluation of Quality of life. It consists of 12 items and the overall sum score is calculated from all 12 items and measured on a scale that ranges from 0 (lowest Quality of life) to 60 (highest level of Quality of life). A negative value in RLS-QoL Change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|Baseline to the end of the 4-week Maintenance Period|Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure.||units on a scale||Standard Deviation|Mean
689793|NCT01455012|Secondary|Change From Baseline in the International Restless Legs Syndrome Rating Scale (IRLS) at the End of the 4-week Maintenance Period|The IRLS is a subject-based scale that consists of 10 items to evaluate the severity of major RLS symptoms and the impact of the disease on subjects' daytime functioning. Each of the 10 items is measured on a scale that ranges from 0 (not present) to 4 (severe). A sum score between 0 (no RLS symptoms present at all) and 40 (maximum severity in all symptoms) across all 10 items was calculated. A negative value in IRLS Change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|Baseline to the end of the 4-week Maintenance Period|Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure.||units on a scale||Standard Deviation|Mean
734190|NCT00424827|Secondary|Resection Rate||1-Year|4 subjects underwent resection after treatment||participants|||Number
689795|NCT01455012|Secondary|Change From Baseline in the Total Number of Elevations of Systolic Blood Pressure (BP) During the Night at the End of the 4-week Maintenance Period|"Polysomnography (PSG) recordings, including the assessment of continuous Blood Pressure and 12-lead Electrocardiogram (ECG), were obtained on 2 consecutive nights prior to Baseline Visit and prior to End of Maintenance Period (Visit 7) for up to 8 hours per night. Readings from the first night of the PSG were only used for analysis if the PSG from the second night was determined to be not valid for evaluation. Influence of Periodic Limb Movements (PLMs) on sleep is reflected in the Periodic Limb Movement-Related Arousal Index (PLMAI). Arousal is defined as sudden change in the EEG activity and the index illustrates to what degree the PLMs contribute to arousal from sleep. Sleep stages and time spent in each sleep stage were determined from Electroencephalogram (EEG) readings.
A negative value in Change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement."|Baseline to the end of the 4-week Maintenance Period|Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure.||Nocturnal Elevations of Systolic BP||Standard Deviation|Mean
689796|NCT01455012|Primary|Change From Baseline in the Number of Elevations of Systolic Blood Pressure (BP) During the Night That Are Associated With Periodic Limb Movements (PLMs) at the End of the 4-week Maintenance Period|"Polysomnography (PSG) recordings, including the assessment of continuous Blood Pressure and 12-lead Electrocardiogram (ECG), were obtained on 2 consecutive nights prior to Baseline Visit and prior to End of Maintenance Period (Visit 7) for up to 8 hours per night. Readings from the first night of the PSG were only used for analysis if the PSG from the second night was determined to be not valid for evaluation. Influence of Periodic Limb Movements (PLMs) on sleep is reflected in the Periodic Limb Movement-Related Arousal Index (PLMAI). Arousal is defined as sudden change in the EEG activity and the index illustrates to what degree the PLMs contribute to arousal from sleep. Sleep stages and time spent in each sleep stage were determined from Electroencephalogram (EEG) readings.
A negative value in Change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement."|Baseline to the end of the 4-week Maintenance Period|Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure.||Nocturnal Elevations of Systolic BP||95% Confidence Interval|Least Squares Mean
689797|NCT01454947|Secondary|Antibiotic Prescribing Rates for Expanded List of Acute Respiratory Infection Diagnoses|We will monitor overall prescribing for the specified diagnoses and other acute respiratory infection diagnoses, including cough/fever and pneumonia.|18 months||||||
689798|NCT01454947|Primary|Inappropriate Antibiotic Prescribing Rate for Qualifying Acute Respiratory Infection Diagnoses|"Assess inappropriate antibiotic prescribing rates (relative to all practices that did not receive the intervention) for antibiotic-inappropriate acute respiratory tract infection visits and no concomitant reason for antibiotic prescribing. based on the following non-antibiotic-appropriate International Statistical Classification of Diseases, version 9 (ICD-9) diagnoses:
460 Acute nasopharyngitis (common cold)
465 Acute laryngeopharyngitis/acute upper respiratory infection
466 Acute bronchitis
490 Bronchitis not specified as acute or chronic
487 Flu"|18 months|We identified a total of 16,959 non-antibiotic-appropriate acute respiratory infection (ARI) visits. Visits were categorized as inappropriate if there were diagnosis codes for non-specific upper respiratory infections, acute bronchitis, and/or influenza.||inappropriate prescribing rate|Qualifying ARI visits|95% Confidence Interval|Number
689799|NCT01454934|Secondary|Objective Response Rate (ORR)|The ORR was defined as the proportion of participants with best overall response of complete response (CR) or partial response (PR) per RECIST criteria. The ORR was estimated by study arm based on the tumor response evaluation as determined by the investigator, according to RECIST 1.1. Participants with unknown response were treated as non-responders. The statistical difference in ORR between treatment arms was evaluated using the Cochran-Mantel-Haenszel (CMH) chi-square test with histology, TPC option, and geographic region as strata, tested at an alpha level of 0.05 (2-sided). The 95 percent confidence interval (CI) was calculated using Clopper Pearson method.|Randomization (Day 1) to CR or PR|Full analysis set included all randomized participants.||Percentage of participants||95% Confidence Interval|Number
689800|NCT01454934|Secondary|Progression Free Survival (PFS) by Response Evaluation Criteria in Solid Tumors (RECIST)|PFS was defined as the time from the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first. The difference in PFS (based on the tumor response evaluation as determined by the investigator) between eribulin and TPC was evaluated using the log rank test, stratified by histology, TPC option, and geographic region, tested at an alpha level of 0.05 (2-sided). PFS censoring rules will be defined in the SAP and follow Federal Department of Agriculture (FDA) guidance.|Randomization (Day 1) until date of disease progression or death (whichever occurred first), or 37 months|Full analysis set included all randomized participants.||Months||95% Confidence Interval|Median
689801|NCT01454934|Primary|Overall Survival (OS)|The OS was defined as the time in months from the date of randomization to the date of death, regardless of cause. In the absence of confirmation of death, the participants were censored either at the date that participant was last known to be alive or the date of study cut-off, whichever was earlier. The two treatment arms were compared using the log-rank test, stratified by histology, TPC option, and geographic region; and the treatment difference between eribulin and TPC was tested at a significance level of 0.05 (2-sided). Kaplan-Meier (K-M) survival probabilities for each arm were plotted over time. The treatment effect was estimated by fitting a Cox Proportional Hazards model to the OS times including treatment arm as a factor and histology, TPC option and geographic region as strata.|Randomization (Day 1) until date of death from any cause, or 37 months|Full analysis set included all randomized participants.||Months||95% Confidence Interval|Median
689802|NCT01454830|Secondary|Acceptability of Study Intervention and Comparative Group|"Feasibility assessment to determine participant acceptance of the study intervention and comparative condition (i.e., usual care); semi-structured interviews conducted with 50% of participants randomly assigned to interview at study termination and debriefing (3 months)"|3 months|"Acceptability rating by participants allocated to interview at study termination and debriefing; self-reported rating for binary response to satisfaction with study experience (yes/no); reported as percentage responding yes; no data available for participants who withdrew or were excluded prior to 3-month visit."||"percentage of allocated responding yes"|||Number
689812|NCT01454778|Primary|Rutherford Classification of Peripheral Arterial Disease|"Evidence of stenosis of lower extremity as measured by the Rutherford Classification post revascularization. The ABI and Rutherford Classification will be assessed at 10 months post revascularization with a lower Rutherford score indicating a better outcome.
0 = Asymptomatic, 1 = Mild Claudication, 2 = Moderate Claudication, 3 = Severe Claudication, 4 = Ischemic Rest Pain, 5 = Minor Tissue Loss, 6 = Ulceration or Gangrene"|10 months|||units on a scale||Standard Deviation|Mean
689813|NCT01454778|Secondary|Number of Serious Adverse Events||Up to 19 months|||Number of SAE's|||Number
689814|NCT01454778|Secondary|Freedom From Binary Restenosis||10 months|||percentage of participants|||Number
689815|NCT01454778|Secondary|Freedom From Target Vessel Revascularization Event||up to 10 months|||percentage of participants|||Number
689816|NCT01454778|Secondary|Freedom From Amputation Event||up to 10 months|||percentage of participants|||Number
689817|NCT01454778|Primary|Evidence of Stenosis Lower Extremity Post Revascularization Using Ankle-Brachial Index Measurement at 10 Months|The Ankle-Brachial Index is calculated as a ratio of the ankle blood pressure and the arm blood pressure. The ABI and Rutherford Classification will be assessed at 10 months post revascularization|10 months|||ratio||Standard Deviation|Mean
689818|NCT01454726|Primary|Change in Dizziness Handicap Inventory (DHI) Questionnaire Score|dizziness Handicap Inventory (DHI) evaluates the self-perceived handicapping effects imposed by vestibular system disease. We employed the final version of DHI, which contains 25 items including 7 physical questions, 9 functional questions and 9 emotional questions. DHI has a total score of 100 points (4 points for each item). Higher scores indicate more severe handicap. Thus the maximum score for DHI is 100, while the minimum core is 0.|0 and 24 hours|Among the 27 participants enrolled in the study, one participant quitted the study before treatment application. Twenty-six patients fulfilled all the procedures and were eligible for the full analysis.||units on a scale||Standard Deviation|Mean
689819|NCT01454583|Secondary|Influence of Anti-hypertensive Treatment on Renal Function|Improvement of the estimated glomerular filtration rate (eGFR, using the CKD-EPI equation) by more than 2.5ml/min/1.73m², compared to baseline|3 years follow up|||percentage of patients|||Number
689820|NCT01454583|Secondary|Influence of Anti-hypertensive Treatment on Renal Function|Improvement of the estimated glomerular filtration rate (eGFR, using the CKD-EPI equation) by more than 2.5ml/min/1.73m², compared to baseline|2 years follow up|||percentage of patients|||Number
689821|NCT01454583|Secondary|Influence of Anti-hypertensive Treatment on Renal Function|Improvement of the estimated glomerular filtration rate (eGFR, using the CKD-EPI equation) by more than 2.5ml/min/1.73m², compared to baseline|1 year follow up|||percentage of patients|||Number
689822|NCT01454583|Secondary|Therapeutic Success of Hypertension Treatment on Diastolic Blood Pressure (DBP) as Measured by 24-hour Blood Pressure Measurement|Relative change of ambulatory, diastolic 24h BP means since baseline, i.e. 24h DBP means at baseline minus corresponding means after 3 years, the differences divided by the baseline value, multiplied by 100. Mean DBP of a patient was calculated as the arithmetic mean of automatically recorded DBP values over a contiguous period of 24 h.|Baseline and 3 years|||percent change||Standard Deviation|Mean
689823|NCT01454583|Secondary|Therapeutic Success of Hypertension Treatment on Systolic Blood Pressure (SBP) as Measured by 24-hour Blood Pressure Measurement|Relative change of ambulatory, systolic 24h BP means since baseline, i.e. 24h SBP means at baseline minus corresponding means after 3 years, the differences divided by the baseline value, multiplied by 100. Mean SBP of a patient was calculated as the arithmetic mean of automatically recorded SBP values over a contiguous period of 24 h.|Baseline and 3 years|||percent change||Standard Deviation|Mean
689824|NCT01454583|Primary|Efficacy of Hypertension Treatment on Diastolic Blood Pressure (DBP)|Relative change of diastolic office blood pressure since baseline, i.e. DBP at baseline minus DBP after 3 years, the difference divided by the baseline value, multiplied by 100|Baseline and 3 years|||percent change||Standard Deviation|Mean
689825|NCT01454583|Primary|Efficacy of Hypertension Treatment on Systolic Blood Pressure (SBP)|Relative change of systolic office blood pressure since baseline, i.e. SBP at baseline minus SBP after 3 years, the difference divided by the baseline value, multiplied by 100|Baseline and 3 years|Patients with DM or HF and RR measurement at baseline and 3 years follow-up||percent change||Standard Deviation|Mean
689826|NCT01454583|Primary|Efficacy of Hypertension Treatment on Diastolic Office Blood Pressure (DBP)|Relative change of diastolic office blood pressure since baseline, i.e. DBP at baseline minus DBP after 1 year, the difference divided by the baseline value, multiplied by 100|Baseline and 2 years|||percent change||Standard Deviation|Mean
689827|NCT01454583|Primary|Efficacy of Hypertension Treatment on Systolic Blood Pressure (SBP)|Relative change of systolic office blood pressure since baseline, i.e. SBP at baseline minus SBP after 2 years, the difference divided by the baseline value, multiplied by 100|Baseline and 2 years|Patients with RR measurement at baseline and 2 years follow-up||percent change||Standard Deviation|Mean
689828|NCT01454583|Primary|Efficacy of Hypertension Treatment on Diastolic Blood Pressure (DBP)|Relative change of diastolic office blood pressure since baseline, i.e. DBP at baseline minus DBP after 1 year, the difference divided by the baseline value, multiplied by 100|Baseline and 1 year|||percent change||Standard Deviation|Mean
689829|NCT01454583|Secondary|Therapeutic Success of Hypertension Treatment on Diastolic Blood Pressure (DBP) as Measured by 24-hour Blood Pressure Measurement|Relative change of ambulatory, diastolic 24h BP means since baseline, i.e. 24h DBP means at baseline minus corresponding means after 2 years, the differences divided by the baseline value, multiplied by 100. Mean DBP of a patient was calculated as the arithmetic mean of automatically recorded DBP values over a contiguous period of 24 h.|Baseline and 2 years|||percent change||Standard Deviation|Mean
689830|NCT01454583|Secondary|Therapeutic Success of Hypertension Treatment on Systolic Blood Pressure (SBP) as Measured by 24-hour Blood Pressure Measurement|Relative change of ambulatory, systolic 24h BP means since baseline, i.e. 24h SBP means at baseline minus corresponding means after 2 years, the differences divided by the baseline value, multiplied by 100. Mean SBP of a patient was calculated as the arithmetic mean of automatically recorded SBP values over a contiguous period of 24 h.|Baseline and 2 years|||percent change||Standard Deviation|Mean
690138|NCT01451398|Secondary|Total Hypoglycemia Event Rate|Number of Hypoglycemic Events/Total Subject Exposure Time (in months)|Baseline to Week 24|Safety population||Events/Subject-Month|||Number
738601|NCT00450723|Primary|Success Rate in Removing Sentinel Lymph Nodes by Thoracoscopy||5 years|||participants|||Number
689831|NCT01454583|Secondary|Therapeutic Success of Hypertension Treatment on Diastolic Blood Pressure (DBP) as Measured by 24-hour Blood Pressure Measurement|Relative change of ambulatory, diastolic 24h BP means since baseline, i.e. 24h DBP means at baseline minus corresponding means after 1 year, the differences divided by the baseline value, multiplied by 100. Mean DBP of a patient was calculated as the arithmetic mean of automatically recorded DBP values over a contiguous period of 24 h.|Baseline and 1 year|||percent change||Standard Deviation|Mean
689832|NCT01454583|Secondary|Therapeutic Success of Hypertension Treatment on Systolic Blood Pressure (SBP) as Measured by 24-hour Blood Pressure Measurement|Relative change of ambulatory, systolic 24h BP means since baseline, i.e. 24h SBP means at baseline minus corresponding means after 1 year, the differences divided by the baseline value, multiplied by 100. Mean SBP of a patient was calculated as the arithmetic mean of automatically recorded SBP values over a contiguous period of 24 h.|Baseline and 1 year|||percent change||Standard Deviation|Mean
689833|NCT01454583|Secondary|Adverse Events|Percentage of participants that experienced at least one adverse event during the three years of observation period|3 years follow up|||percentage of patients|||Number
689834|NCT01454583|Secondary|Adverse Events|Percentage of participants that experienced at least one adverse event during the first two years of observation period|2 years follow up|||percentage of patients|||Number
689835|NCT01454583|Secondary|Adverse Events|Percentage of participants that experienced at least one adverse event during the first year of observation period|1 year follow up|||percentage of patients|||Number
689836|NCT01454583|Secondary|Therapy Adherence Regarding Drug Treatment|Percentage of patients not having changed the therapy group after 3 years (DRI, ARB/ACE-I, or No-RAS-I, referring to their therapy at baseline)|Baseline and 3 years|||percentage of patients|||Number
689837|NCT01454583|Secondary|Therapy Adherence Regarding Drug Treatment|Percentage of patients not having changed the therapy group after 2 years (DRI, ARB/ACE-I, or No-RAS-I, referring to their therapy at baseline)|Baseline and 2 years|||percentage of patients|||Number
689838|NCT01454583|Secondary|Therapy Adherence Regarding Drug Treatment|Percentage of patients not having changed the therapy group after 1 year (DRI, ARB/ACE-I, or No-RAS-I, referring to their therapy at baseline)|Baseline and 1 year|||percentage of patients|||Number
689839|NCT01454583|Primary|Efficacy of Hypertension Treatment on Systolic Blood Pressure (SBP)|Relative change of systolic office blood pressure since baseline, i.e. SBP at baseline minus SBP after 1 year, the difference divided by the baseline value, multiplied by 100|baseline and 1 year|||percent change||Standard Deviation|Mean
689840|NCT01454531|Secondary|Change in Immediate Cutaneous Response to Phleum Pratense|Wheal size provoked after prick test with 4, 20 and 100 µg/ml Phl p 5 allergen extracts analysed by Parallel Line Assay. Cutaneous Tolerance Index (CTI) is the factor it is necessary to multiply the extract concentration by after SCIT (V6) to obtain the same response in terms of wheal area as at baseline (V1). CTI, being an index, is a dimensionless measure. A CTI of 1 indicates no change in skin sensitivity while if higher than 1 a decrease in skin sensitivity (it would be needed a more concentrated allergen extract at V6 to elicit the same skin response as at V1|baseline (visit 1) and at 6 weeks (visit 6)|Participants in which results of the Parallel Line Assay are valid||CTI, Cutaneous Tolerance Index||95% Confidence Interval|Mean
689841|NCT01454531|Secondary|Change in Phleum Pratense Specific IgG4||baseline (visit 1) and at 6 weeks (visit 6)|Number of subject with valid data in visit 1 and visit 6||mgA/l||Standard Deviation|Mean
689842|NCT01454531|Secondary|Change in Phleum Pratense Specific IgE-blocking Factor|"IgE-blocking factor measures the amount of IgE bound to the allergen in the presence of allergen-competing factors present in the serum of a subject treated with allergen immunotherapy. The test is based in a double IgE measurement, an ordinary assay and an assay in the presence of competing components and takes the form of:
IgE blocking factor = 1 - (Competitive IgE/Ordinary IgE). Theoretical limits are from 0 (no IgE blocked) to 1 (all IgE blocked) and, being a ratio, is a dimensionless measure"|baseline (visit 1) and at 6 weeks (visit 6)|||arbitrary units||Standard Deviation|Mean
689843|NCT01454531|Secondary|Frequency of Subjects With Local Adverse Reaction|Frequency of patients with local adverse reactions|6 weeks|||participants|||Number
689844|NCT01454531|Secondary|Frequency of Subjects With Systemic Reactions|Frequency of patients with systemic reactions, based on EAACI classification: Grade I (mild systemic reaction) to IV (anaphylactic shock)|6 weeks|||participants|||Number
689845|NCT01454531|Primary|Frequency of Subjects With Adverse Drug Reactions|Frequency of patients with adverse reactions, local or systemic|6 weeks|Subjects treated||participants|||Number
689846|NCT01454505|Primary|Mean Change From Baseline in Nasal Congestion Over a 6-hour Period in the EEC at Day 5|Stage B: Nasal congestion was assessed by the subject before entering the EEC and at 14 timepoints over a 6-hour period after entering the EEC. Nasal congestion was scored on a scale from 0-3, where 0=none and 3=severe. Baseline EEC was conducted up to 21 days prior to the 5-day treatment period.|Baseline (pretreatment), Day 5|Stage B: This reporting group includes all randomized subjects who satisfied inclusion/exclusion criteria and had EEC data at baseline and Day 5, per protocol.||Units on a scale||Standard Deviation|Mean
689847|NCT01454505|Secondary|Mean Change From Baseline in Total Nasal Symptom Scores (TNSS) Over a 6-hour Period in the EEC at Day 5|Stage B: Nasal symptoms were assessed by the subject before entering the EEC and at 14 timepoints over a 6-hour period after entering the EEC. TNSS score (0-12) was a sum of scores for nasal congestion, sneezing, itchy nose, and runny nose scores, each individually assessed on a 0 to 3 scale, where 0=none and 3=severe. Baseline EEC was conducted up to 21 days prior to the 5-day treatment period.|Baseline (pretreatment), Day 5|Stage B: This reporting group includes all randomized subjects who satisfied inclusion/exclusion criteria and had EEC data at baseline and Day 5, per protocol.||Units on a scale||Standard Deviation|Mean
689848|NCT01454505|Primary|Number of Adverse Events in Stage A|Adverse events, including serious adverse events and deaths, were reported regardless of test article relationship.|Day 1|This reporting group includes all subjects exposed to test article during Stage A.||Adverse Events|||Number
689990|NCT01453049|Secondary|Change From Baseline in High Sensitivity C-reactive Protein (Hs-CRP) at Week 24/EW|Blood samples of participants were collected for hs-CRP assessment. CRP is a marker of inflammation. High levels of CRP predict the risk of heart disease and diabetes. Change from Baseline in hs-CRP was calculated as the value at Week 24/EW minus the value at Baseline.|Baseline (Week 0) and Week 24/EW|FAS. Only those participants contributing data at the indicated time points were analyzed.||mmol/L||Standard Deviation|Mean
689849|NCT01454414|Secondary|Seroconversion Against a Tick-borne Illness|We will define seroconversion as one in which there is a 4-fold change in Immunoglobulin G class antibody titer between sera at enrollment, sera obtained after one year and/or sera obtained at study's end or between acute and convalescent sera for participants developing an acute illness. The antigens that will be used in the serologic assays include Ehrlichia chaffeensis (which would also detect antibodies to E. ewingii and Anaplasma phagocytophilum) and Rickettsia rickettsii (which would also detect antibodies to other spotted fever group rickettsiae).|Upon enrollment, after the first year, and after the second year||||||
689850|NCT01454414|Primary|Work Related Tick Bites|Tick bites are defined as ticks attached to or embedded in the skin|Weekly for two years|||tick bites|||Number
689851|NCT01454401|Primary|Ulcer Healing Within 20 Weeks|Number of the patients achieved complete epithelialization at 20 weeks in the ITT population and in the PP population.|20 weeks|Number of the patients achieved complete epithelialisation at 20 weeks in the ITT population and in the PP population||participants|||Number
689852|NCT01454401|Secondary|Ulcer Healing Within 12 Weeks.|Number of the patients achieved complete epithelialisation at 12 weeks (ITT population) and the percentage respectively in the PP population|12 weeks|Complete epithelialisation was achieved in 15 patients (34%) in ITT population and 38% in the PP population||participants|||Number
689853|NCT01454258|Primary|Number of Different Substitution Solutions Administered||24h|Surgical patients from 10 hospitals over a period of 13 months||participants|||Number
689854|NCT01454063|Secondary|Ocular Pain VAS Score After Day of Surgery - Day 1|Pain VAS scores (where 0 = no pain and 100 = worst possible pain) after the day of surgery summarized by treatment arm and time-point.|One day|Number of subjects with scores at time point.||units on a scale||Standard Deviation|Mean
689855|NCT01454063|Secondary|Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade on Day 1|"The mean SOIS summarized by treatment arm and time point on Day 1 postoperatively. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject’s anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.
Grading was as follows:
Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.
Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous"|One day|Subjects with score at time point.||units on a scale||Standard Deviation|Mean
689856|NCT01454063|Secondary|Best Corrected Visual Acuity (BVCA) Log Score on Day 1|Best-Corrected Visual Acuity (BCVA) summarized by the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity log score. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis.|One day|Subject who could read well enough to obtain visual acuity score.||Log score||Standard Deviation|Mean
689857|NCT01454063|Secondary|Photophobia at Day 1 After Surgery (Ocular Pain and Symptoms Numerical Ordinal Scale [Numerical Rating System - NRS] Scores)|Photophobia outcomes based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at Day 1 postoperatively|One day|Subjects with scores at time point.||participants|||Number
689858|NCT01454063|Secondary|Photophobia at 6 Hours After Surgery (Ocular Pain and Symptoms Numerical Ordinal Scale [Numerical Rating System - NRS] Scores)|Photophobia outcomes based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at 6 hours postoperatively.|Six hours postoperatively|Subjects with scores at time point.||participants|||Number
689859|NCT01454063|Secondary|Mean Area-under-the-Curve Analysis of Ocular Pain Visual Analog Scale (VAS) Score Within 12 Hours Postoperatively|The primary analysis of the ocular pain VAS (where 0 = no pain and 100 = worst possible pain) was based on the mean area-under-the-curve (AUC). The AUC of the ocular pain VAS during 12 hours postoperatively was calculated by the trapezoidal rule in which the hour 11 was used to represent the time-point 10-12 hours. The mean AUC was defined as the AUC divided by the number of hours with ocular pain VAS results during the first 12 hours postoperatively.|12 hours|Subjects with scores at time points.||units on a scale||Standard Deviation|Mean
689860|NCT01454063|Primary|Mean Area-under-the-Curve (AUC) Analysis of Change From Baseline in Pupil Diameter (mm) During Surgery|"Change in pupil diameter over time from surgical baseline (immediately prior to surgical incision) to the end of the surgical procedure (wound closure) was summarized using descriptive statistics by treatment arm and time-point (every minute).
The primary analysis of the change in pupil diameter was based on the mean area-under-the-curve (AUC) pupil diameter change from baseline. First, the AUC of the pupil diameter from surgical baseline to wound closure was calculated using the trapezoidal rule. Second, the mean AUC was obtained by dividing the AUC by the total time of surgery. Third, the mean AUC of change from baseline was calculated by subtracting the baseline pupil diameter from the mean AUC."|from surgery baseline (pre-incision) through surgery end (time of cortical clean-up/wound closure)|Subjects with interpretable video images obtained during intraocular lens replacement (ILR) procedure.||mm||Standard Deviation|Mean
689861|NCT01453998|Primary|Concentrations for Anti-Pertussis Toxoid.||One month after the booster dose||12/2020||||
689862|NCT01453998|Primary|Concentrations for Anti-poliovirus Types 1, 2 and 3||One month after the booster dose||12/2020||||
689863|NCT01453998|Primary|Number of Seroprotected Subjects for Anti-Pertussis Toxoid.||One month after the booster dose||12/2020||||
689864|NCT01453998|Primary|Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3.||One month after the booster dose||12/2020||||
689865|NCT01453998|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Any SAE = any SAE regardless of assessment of relationship to study vaccination.|During the entire study period (Days 0-30). (subjects enrolled after protocol amendment 2)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the booster vaccine administration documented.||Subjects|||Number
729184|NCT00367055|Secondary|Median Change From Baseline in Beta Cell Function Index (HOMA-beta) After a 36-month Treatment||Baseline and Month 36||||||
689866|NCT01453998|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)|An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an AE regardless of intensity grade or relationship to study vaccination.|Within the 31-day (Days 0-30) follow up period after vaccination. (subjects enrolled after protocol amendment 2)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the booster vaccine administration documented.||Subjects|||Number
689867|NCT01453998|Secondary|Number of Subjects Reporting Any Solicited General Symptoms|Solicited local symptoms assessed were drowsiness, irritability/fussiness, loss of appetite and fever [axillary temperature above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any local symptom regardless of intensity grade.|During the 4-day (Days 0-3) post-vaccination period. (subjects enrolled after protocol amendment 2)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the booster vaccine administration documented.||Subjects|||Number
689868|NCT01453998|Secondary|Number of Subjects Reporting Any Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.|During the 4-day (Days 0-3) post-vaccination period. (subjects enrolled after protocol amendment 2)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the booster vaccine administration documented.||Subjects|||Number
689869|NCT01453998|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Any SAE = any SAE regardless of assessment of relationship to study vaccination.|During the entire study period (Days 0-30). (subjects enrolled before protocol amendment 2)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the booster vaccine administration documented.||Subjects|||Number
689870|NCT01453998|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).|An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an AE regardless of intensity grade or relationship to study vaccination.|Within the 31-day (Days 0-30) follow up period after vaccination. (subjects enrolled before protocol amendment 2)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the booster vaccine administration documented.||Subjects|||Number
689871|NCT01453998|Secondary|Number of Subjects Reporting Any Solicited General Symptoms.|Solicited local symptoms assessed were drowsiness, irritability/fussiness, loss of appetite and fever [axillary temperature above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any local symptom regardless of intensity grade.|During the 4-day (Days 0-3) post-vaccination period. (subjects enrolled before protocol amendment 2)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the booster vaccine administration documented.||Subjects|||Number
689872|NCT01453998|Secondary|Number of Subjects Reporting Any Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.|During the 4-day (Days 0-3) post-vaccination period. (subjects enrolled before protocol amendment 2)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the booster vaccine administration documented.||Subjects|||Number
689873|NCT01453998|Secondary|Concentrations for Anti-PNE Antibodies.|Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 0.15 µg /mL. The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.|Before (PRE) and 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.||µg /mL||95% Confidence Interval|Geometric Mean
689874|NCT01453998|Secondary|Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes|A seropositive subject was defined as a vaccinated subject who had anti- pneumococcal antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL). The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.|1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.||Subjects|||Number
689875|NCT01453998|Secondary|Concentrations for Anti-PNE Antibodies.|Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 0.15 µg /mL. The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.|Before (PRE) and 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.||µg /mL||95% Confidence Interval|Geometric Mean
689876|NCT01453998|Secondary|Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.|A seropositive subject was defined as a vaccinated subject who had anti- pneumococcal antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL). The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.|1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.||Subjects|||Number
689877|NCT01453998|Primary|Concentrations for Anti-PRP Antibodies.|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.15 µg /mL.|Before (PRE) and 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.||µg /mL||95% Confidence Interval|Geometric Mean
689878|NCT01453998|Primary|Number of Seroprotected Subjects for Anti-polyribosyl-ribitol Phosphate (Anti-PRP).|A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).|Before (PRE) and 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.||Subjects|||Number
689879|NCT01453998|Primary|Concentrations for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL.|Before (PRE) and 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.||IU/mL||95% Confidence Interval|Geometric Mean
689880|NCT01453998|Primary|Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies|A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).|Before (PRE) and 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.||Subjects|||Number
689881|NCT01453998|Primary|Concentrations for Anti-PRP Antibodies|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.15 µg /mL.|Before (PRE) and 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.||µg /mL||95% Confidence Interval|Geometric Mean
689882|NCT01453998|Primary|Number of Seroprotected Subjects for Anti-polyribosyl-ribitol Phosphate (Anti-PRP)|A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).|Before (PRE) and 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.||Subjects|||Number
689883|NCT01453998|Primary|Concentrations for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL.|Before (PRE) and 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.||IU/mL||95% Confidence Interval|Geometric Mean
689884|NCT01453998|Primary|Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.|A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).|Before (PRE) and 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.||Subjects|||Number
689885|NCT01453946|Primary|Adverse Event|Any kind of adverse event|16 weeks|Safety analysis set||Subjects|||Number
689886|NCT01453946|Secondary|IMPACT 3|IMPACT-III - A QUALITY OF LIFE QUESTIONNAIRE FOR CHILDREN WITH INFLAMMATORY BOWEL DISEASE|12 weeks|Safety analysis set||Score units||Standard Deviation|Mean
689887|NCT01453946|Secondary|PCDAI|Pediatric Crohn's Disease Activity Index. The scale ranges from 0 (no activity) to 100 (high activity)|12 weeks|Full Analysis Set||Scores on a scale||Standard Deviation|Mean
689888|NCT01453894|Primary|Completion of a Fecal Occult Blood Test (FOBT)|This outcome will be categorized as Completed FOBT if a participant's chart has documentation of a completed FOBT screening test. Outcomes will be assessed by querying the electronic health record (EHR) for all participants.|within 6 months of randomization|||participants|||Number
689889|NCT01453855|Primary|Mean Intraocular Pressure (IOP) at Week 2, Week 6, and Month 3 for Each Assessment Time Point (8 AM, 10 AM, and 4 PM)|As measured by Goldmann applanation tonometry. One eye from each subject was chosen as the study eye and only the study eye was used in the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).|Week 2, Week 6, Month 3 (8 AM, 10 AM, 4 PM)|The intent-to-treat (ITT) analysis set included all patients who received study drug and completed at least 1 scheduled on-therapy study visit. In addition, no imputation methods were employed; therefore only efficacy measurements available at each visit and time point were analyzed.||millimeters mercury (mmHg)||Standard Error|Least Squares Mean
729185|NCT00367055|Secondary|Median Change From Baseline in Insulin Resistance Index (HOMA-IR) After a 36-month Treatment||Baseline and Month 36||||||
689890|NCT01453725|Primary|Percentage of Participants Who Discontinued Study Drug Due to an AE|An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not considered related to the study drug. The percentages of participants who discontinued study drug due to an AE were calculated for each part of the study. Participants may have discontinued study drug without discontinuing from the study.|Up to 16 weeks for Part 1; Week 16 through up to 48 weeks for Part 2|The APaT population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.||Percentage of Participants|||Number
689891|NCT01453725|Primary|Percentage of Participants Who Experienced at Least One Adverse Event (AE)|An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not considered related to the study drug. The percentages of participants who experienced at least one AE were calculated for each part of the study.|Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)|The All-Participants-as-Treated (APaT) population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.||Percentage of Participants|||Number
689892|NCT01453725|Secondary|Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Sacroiliac (SI) Joints Score at Week 16|Participants underwent MRI of the SI joints, without contrast, at Screening and Week 16 to assess the presence or absence of active inflammation of the SI joints. Scoring was based on 6 consecutive MRI slices through the SI joint. Each slice was divided into 4 quadrants. Each of the 48 quadrants was scored with respect to the presence of inflammation (0=no, 1=yes), yielding a maximum score of 48. Each slice was also assessed for the presence of a lesion exhibiting either intense signal or a depth >=1 cm anywhere within the SI joint of the 6 slices (0=no, 1=yes), yielding a maximum score of 24. Total SI joint scores could range from 0 to 72, with a higher score indicating more signs of disease.|Baseline and Week 16|The FAS population consisted of all randomized participants who received at least one dose of study drug in Part 1, who completed Part 1, and who had Baseline and Week 16 MRI SI joint measurements.||Score on a Scale||Standard Deviation|Mean
689893|NCT01453725|Secondary|Percentage of Participants Achieving ASAS Partial Remission at Week 16|ASAS partial remission was defined as a VAS score of less than 20 mm in each of the 4 domains of ASAS 20: participant global assessment, pain (total back pain), function and inflammation. The percentages of participants who achieved ASAS partial remission were calculated.|Week 16|The FAS population consisted of all randomized participants who received at least one dose of study drug in Part 1.||Percentage of Participants|||Number
689894|NCT01453725|Secondary|Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 at Week 16|The BASDAI is a summary of 6 participant-assessed 100-mm VAS for a) Fatigue, b) Spinal pain (overall), c) Peripheral arthritis, d) Enthesitis, e) Qualitative morning stiffness (intensity) and f) Quantitative morning stiffness (duration). Each VAS is measured as 0=none to 100=very severe, with a higher score indicating more severe symptoms. The BASDAI score is calculated as 0.2 time (a+b+c+d+[0.5 times e+f]) and can range from 0 to 100. The BASDAI 50 is defined as improvement by at least 50% from Baseline in the BASDAI score. The percentages of participants who achieved BASDAI 50 were calculated.|Week 16|The FAS population consisted of all randomized participants who received at least one dose of study drug in Part 1 and had a Baseline BASDAI assessement.||Percentage of Participants|||Number
689895|NCT01453725|Secondary|Percentage of Participants Achieving an Assessment in Ankylosing Spondylitis (ASAS) 40 Response at Week 16|The ASAS consists of 4 domains: participant global assessment, total back pain, function (BASFI), and inflammation (mean of questions 5 and 6 of BASDAI). Each domain is measured on a 100-mm VAS from 0 mm=the very best situation to 100 mm=the very worst situation, with a higher score indicating more severe impairment. ASAS 40 is a 40% improvement in response (per the Assessment in Ankylosing Spondylitis International Working Group) defined as meeting 2 criteria: 1) An improvement of >=40% from Baseline and an absolute improvement from Baseline of >=20 mm in at least 3 of 4 domains, and 2) Absence of deterioration from Baseline (defined as a >=0% worsening and an absolute worsening of >=0 mm) in the potential remaining domain. The percentages of participants who achieved ASAS 40 were calculated.|Week 16|The FAS population consisted of all randomized participants who received at least one dose of study drug in Part 1.||Percentage of Participants|||Number
689896|NCT01453725|Primary|Percentage of Participants Achieving an Assessment in Ankylosing Spondylitis (ASAS) 20 Response at Week 16|The ASAS consists of 4 domains: participant global assessment, total back pain, function (Bath Ankylosing Spondylitis Functional Index [BASFI]), and inflammation (mean of questions 5 and 6 of Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]). Each domain is measured on a 100-mm visual analog scale (VAS) from 0 mm=the very best situation to 100 mm=the very worst situation, with a higher score indicating more severe impairment. ASAS 20 is a 20% improvement in response (per the Assessment in Ankylosing Spondylitis International Working Group) defined as meeting 2 criteria: 1) An improvement of >=20% from Baseline and an absolute improvement from Baseline of >=10 mm in at least 3 of 4 domains, and 2) Absence of deterioration from Baseline (defined as a >=20% worsening and an absolute worsening of >=10 mm) in the potential remaining domain. The percentages of participants who achieved ASAS 20 were calculated.|Week 16|The Full-Analysis-Set (FAS) population consisted of all randomized participants who received at least one dose of study drug in Part 1.||Percentage of Participants|||Number
689897|NCT01453595|Primary|Objective Response Rate (ORR)|In patients with advanced clear cell RCC, progressing after prior first-line or second-line mTOR therapy. The determination of antitumor efficacy will be based on objective tumor assessments made according to the RECIST1.1.|1 year|ORR was only assessed for participants who completed the study, which were only 5 patients on Cohort -1||participants|||Number
689960|NCT01453296|Primary|Reticulocyte and Red Blood Cell (RBC) Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of reticulocytes and RBCs at Day 14 of the respective treatment period. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.|Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||10^12 cells per liter (TI/L)||Standard Deviation|Mean
689898|NCT01453569|Secondary|Change of Neuropsychiatric Inventory(NPI) After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule|Neuropsychiatric Inventory (NPI) is a scale to obtain information on the presence of psychopathology in patient with brain disorders. The NPI was developed for application to patients with AD and other dementias, but it may be useful in the assessment of behavioral changes in other conditions. Twelve behavioral areas included in the NPI will be assessed in this trial: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety and elation/euphoria, et al. The total score ranges 0 to 120, the higher score indicates worse state of the AD patient. Change after 24wks treatmnt was calculated by the week 24 minus week 0 (baseline), and a negative change represents an improvement.|24 weeks|85, 84, 86 patients were enrolled, and 2, 8 and 3 subjects were excluded from FAS in placebo, 600 mg and 900 mg group respectively. So the case No. ananlysed were 83, 76, 83 for placebo, 600 mg and 900 mg group respectively.||units on a scale||Standard Error|Mean
689899|NCT01453569|Secondary|Change of Alzheimer's Disease Cooperative Study/Activities of Daily(ADCS-ADL) After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule|Alzheimer's Disease Cooperative Study/Activities of Daily (ADCS-ADL) is a scale assessed the daily activties of AD patients after interviewed the caregiver. The scale mainly assess the eating, walking, writing, bathing and reading, et al of the subject. The total score ranges 0-78, the higher score indicate improvement in daily activities. Change after 24 wks treatment was calculated by the week 24 minus week 0 (baseline), and a positive change represents an improvement.|24 weeks|85, 84, 86 patients were enrolled, and 2, 8 and 3 subjects were excluded from FAS in placebo, 600 mg and 900 mg group respectively. So the case No. ananlysed were 83, 76, 83 for placebo, 600 mg and 900 mg group respectively.||units on a scale||Standard Error|Mean
689900|NCT01453569|Secondary|Change of Clinician's Interview-Based Impression of Change Plus(CIBIC-plus) After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule|Clinician's Interview-Based Impression of Change Plus(CIBIC-plus) is widely used in antidementia drug trials. It comprises Likert scales for disease severity and changes, and written accounts summarizing semistructured interviews evaluating behavior, cognition, and function. The results classified as 7 degrades as: Markedly improved, Moderately improved, Minimally improved, No change, Minimally worse, Moderately worse, and Markedly worse.|24 weeks|||participants|||Number
689901|NCT01453569|Primary|Change of Alzheimer's Disease Assessment Scale-cognitive Subscale(ADAS-cog)/12 After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule|Alzheimer's Disease Assessment Scale-cognitive Subscale(ADAS-cog)/12 is the most popular cognitive testing instrument used in clinical trials. It consists of 12 tasks measuring the disturbances of memory, language, praxis, attention and other cognitive abilities which are often referred to as the core symptoms of AD. The total score ranges 0-75, the higher score indicates more severity of the disease. Change after 24 wks treatment was calculated by the week 24 minus week 0 (baseline), and a negative change represents an improvement.|24 weeks|85, 84, 86 patients were enrolled, and 2, 8 and 3 subjects were excluded from FAS in placebo, 600 mg and 900 mg group respectively. So the case No. ananlysed were 83, 76, 83 for placebo, 600 mg and 900 mg group respectively.||units on a scale||Standard Error|Mean
689902|NCT01453413|Secondary|Percent of Subjects Outside a Second Specified Blood Glucose (BG) Range -Estimated Versus Measured Blood Glucose|The percent of subjects whose estimated blood glucose values are different than meter BG values. A calculation was performed to determine the percent of subjects whose estimated BG values are > +/-15% different than meter BG values when samples have BG >=100 mg/dL or > +/- 15 mg/dL different than meter BG values when samples have BG <100 mg/dL, as measured by fingerstick CONTOUR®.|1 visit 15-20 minutes|Three subjects were excluded from analyses due to inconsistencies in responses to inclusion/exclusion questions(297-3=294). Eight subjects were excluded from BG analyses because they did not have both an estimated BG value and a meter result (294-8=286)||percentage of subjects||95% Confidence Interval|Number
689903|NCT01453413|Primary|Percent of Subjects Outside Specified Blood Glucose (BG) Range -Estimated Versus Measured Blood Glucose|The percent of subjects whose estimated blood glucose values are different than meter BG values. A calculation was performed to determine the percent of subjects whose estimated BG values are > +/-20% different than meter BG values when samples have BG >=75mg/dL or > +/- 15mg/dL different than meter BG values when samples have BG <75mg/dL, as measured by fingerstick CONTOUR®.|1 visit 15-20 minutes|Three subjects were excluded from analyses due to inconsistencies in responses to inclusion/exclusion questions(297-3=294). Eight subjects were excluded from BG analyses because they did not have both an estimated BG value and a meter result (294-8=286)||percentage of subjects||95% Confidence Interval|Number
689904|NCT01453387|Secondary|Percentage of Subjects With Clinical Benefit|Clinical benefit was to be confirmed by CR, PR or stable disease (SD) lasting at least 6 weeks (using RECIST v1.0) during treatment. CR: The disappearance of all target and non-target lesions and normalization of tumor marker level; PR: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the sum of the longest diameter at baseline; SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of the longest diameter since treatment started.|Every 6 Weeks until complete response or till data cut-off date 15 July 2013|The efficacy analysis set included all subjects who received at least 1(non-zero) dose of MSC2015103B and had a baseline tumor assessment.||percentage of subjects|||Number
689905|NCT01453387|Secondary|Percentage of Subjects With Overall Response|Overall response was to be confirmed by complete response (CR) or partial response (PR) using response evaluation criteria in solid tumours Version 1.0 (RECIST) during treatment. CR: The disappearance of all target and non-target lesions and normalization of tumor marker level; PR: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the sum of the longest diameter at baseline.|Every 6 Weeks until complete response or till data cut-off date 15 July 2013|The efficacy analysis set included all subjects who received at least 1(non-zero) dose of MSC2015103B and had a baseline tumor assessment.||percentage of subjects|||Number
689906|NCT01453387|Secondary|Extracellular Signal-regulated Kinase (ERK) Phosphorylation Levels|ERK phosphorylation levels were to be assessed in peripheral blood mononuclear cells (PBMC) during the dose escalation|Schedule 1: Day 1: Pre-dose; Post-dose: 2, 4, 8, 24 hour; 48 or 72 hour; 48 or 96 hour, 168 hour; Day 15: Pre-dose; Schedule 2: Day 1: Pre-dose; Post-dose: 2, 8, 24, 48, 96 hour; Day 15: Pre-dose; Day 17: Pre-dose; Post-dose: 2, 8, and 24 hour|As the trial was terminated early due to administrative reason, it was decided as per Statistical Analysis Plan not to evaluate the biomarker data for this study.|||||
690139|NCT01451398|Secondary|Incidence of Severe Hypoglycemia|Severe Hypoglycemia defined as: Requiring 3rd party assistance.|Baseline to Week 24|Safety population||percentage of participants|||Number
689907|NCT01453387|Secondary|Apparent Volume of Distribution Associated to the Terminal Phase (Vz/f)|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution after oral dose (Vz/f) was influenced by the fraction absorbed.|Schedule 1: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, 24.0, 48 or 72, 72 or 96 and 168 hours post-dose during Week 1; Schedule 2: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, and 24.0 hours post-dose on Day 1.|"Pharmacokinetic analysis set included all the subjects who received at least 1 dose of MSC2015103B and who provided sufficient plasma concentrations of MSC2015103B measurement after the first dose. n signifies the number of subjects evaluable for the particular timepoint."||Liter||Full Range|Geometric Mean
689908|NCT01453387|Secondary|Apparent Oral Clearance of the Drug From Plasma (CL/f)|Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. CL/f was influenced by the fraction absorbed.|Schedule 1: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, 24.0, 48 or 72, 72 or 96 and 168 hours post-dose during Week 1; Schedule 2: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, and 24.0 hours post-dose on Day 1.|"Pharmacokinetic analysis set included all the subjects who have received at least one dose of MSC2015103B and who have provided sufficient plasma concentrations of MSC2015103B measurement after the first dose. N signifies the total number of subjects evaluable for this outcome measure."||Liter/hour||Full Range|Geometric Mean
689909|NCT01453387|Secondary|AUC Versus Time Curve Within One Dosing Interval (AUC0-tau)||Schedule 1: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, 24.0, 48 or 72, 72 or 96 and 168 hours post-dose during Week 1 and Week 3; Schedule 2: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, and 24.0 hours post-dose on Day 1 and 17.|"Pharmacokinetic analysis set included all the subjects who received at least 1 dose of MSC2015103B and provided sufficient plasma concentrations of MSC2015103B measurement after the first dose. n signifies the number of subjects evaluable for the particular timepoint."||hours*picogram/milliliter||Full Range|Geometric Mean
689910|NCT01453387|Secondary|Area Under the Plasma Concentration Curve From Time Zero to Infinity (AUC[0-inf])|The AUC(0-inf) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity.|Schedule 1: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, 24.0, 48 or 72, 72 or 96 and 168 hours post-dose during Week 1 and Week 3; Schedule 2: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, and 24.0 hours post-dose on Day 1 and 17.|"Pharmacokinetic analysis set included all the subjects who have received at least 1 dose of MSC2015103B and provided sufficient plasma concentrations of MSC2015103B measurement after the first dose. n signifies the number of subjects evaluable for the particular timepoint."||Hour*picogram/milliliter||Full Range|Geometric Mean
689911|NCT01453387|Secondary|Apparent Terminal Half Life (T1/2)|The apparent terminal half-life was defined as the time required for the plasma concentration of drug to decrease 50% in the final stage of its elimination.|Schedule 1: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, 24.0, 48 or 72, 72 or 96 and 168 hours post-dose during Week 1 and Week 3; Schedule 2: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, and 24.0 hours post-dose on Day 1 and 17.|"Pharmacokinetic analysis set included all the subjects who received at least 1 dose of MSC2015103B and provided sufficient plasma concentrations of MSC2015103B measurement after the first dose.n signifies the number of subjects evaluable for the particular timepoint."||Hour||Full Range|Geometric Mean
689912|NCT01453387|Secondary|Time to Reach Maximum Plasma Concentration (Tmax)||Schedule 1: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, 24.0, 48 or 72, 72 or 96 and 168 hours post-dose during Week 1 and Week 3; Schedule 2: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, and 24.0 hours post-dose on Day 1 and 17.|"Pharmacokinetic analysis set included all the subjects who received at least 1 dose of MSC2015103B and provided sufficient plasma concentrations of MSC2015103B measurement after the first dose. n signifies the number of subjects evaluable for the particular timepoint."||Hour||Full Range|Geometric Mean
689913|NCT01453387|Secondary|Maximum Plasma Concentration (Cmax)||Schedule 1 : 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, 24.0, 48 or 72, 72 or 96 and 168 hours post-dose during Week 1 and Week 3; Schedule 2: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, and 24.0 hours post-dose on Days 1 and 17.|"Pharmacokinetic analysis set included all the subjects who received at least 1 dose of MSC2015103B and provided sufficient plasma concentrations of MSC2015103B measurement after the first dose. n signifies the number of subjects evaluable for the particular timepoint."||Picogram per milliliter||Full Range|Geometric Mean
689914|NCT01453387|Secondary|Number of Subjects Who Experienced Clinically Significant Lab Abnormality Judged to be Related to the Trial Medication|Abnormal laboratory findings and other abnormal investigational findings which were associated with clinical signs and symptoms, lead to treatment discontinuation, or considered medically important by the investigator were reported as AEs.|From the initiation of the trial till the data cut-off date 15 July 2013|The safety analysis set included all the subjects who received at least one administration of the trial medication.||Subjects|||Number
689915|NCT01453387|Secondary|Percentage of Subjects Who Experienced Clinically Significant Lab Abnormality Judged to be Related to the Trial Medication|Abnormal laboratory findings and other abnormal investigational findings which were associated with clinical signs and symptoms, lead to treatment discontinuation, or considered medically important by the investigator were reported as AEs.|From the initiation of the trial till the data cut-off date 15 July 2013|The safety analysis set included all the subjects who received at least one administration of the trial medication.||Percentage of subjects|||Number
689916|NCT01453387|Secondary|Percentage of Subjects Who Experienced Any Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death and TEAEs Leading to Discontinuation|An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. SAE (Serious adverse event) is defined as any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition.. TEAEs are events between first dose of study drug up to the cut-off date (15 July 2013) and were absent before treatment or that worsened relative to pretreatment state.|From the initiation of the trial till the data cut-off date 15 July 2013|The safety analysis set included all the subjects who received at least one administration of the trial medication.||Percentage of subjects|||Number
690062|NCT01452126|Primary|Effective Concentration of Ropivacaine to Produce Surgical Anesthesia in 50% of Population|The concentration of ropivacaine for each patient's nerve-block injection was determined per protocol.|1 day|||percentage concentration, ropivacaine|||Number
689917|NCT01453387|Primary|Percentage of Subjects Who Experienced DLT|DLT was evaluated using the National cancer institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. DLT was defined as any of the following AEs occurring during Cycle 1 that are not related to PD at any dose level: Any Grade 3 or more non-hematological toxicity excluding: Grade 3 diarrhea or associated electrolyte abnormalities that were controlled with adequate and optimal therapies, Grade 3 liver function abnormalities which resolved within 7 days, vomiting. Grade 4 neutropenia of greater than (>) 5 days duration or Grade 3 febrile neutropenia, Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding, any severe or life threatening AE or any AE or abnormality which impairs daily normal physiological functions, any treatment delay for 2 weeks or more due to adverse effects not related to PD. All events judged to be related by the Investigator to PD were excluded from the DLT definition.|Up to Day 21 of Cycle 1|Safety analysis set included all subjects who received at least one administration of the trial medication.||Percentage of subjects|||Number
689918|NCT01453387|Primary|Number of Subjects Who Experienced Dose-limiting Toxicities (DLT)|DLT was evaluated using the National cancer institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. DLT was defined as any of the following AEs occurring during Cycle 1 that are not related to progressive disease (PD) at any dose level: Any Grade 3 or more non-hematological toxicity excluding: Grade 3 diarrhea or associated electrolyte abnormalities that were controlled with adequate and optimal therapies, Grade 3 liver function abnormalities which resolved within 7 days, vomiting. Grade 4 neutropenia of greater than (>) 5 days duration or Grade 3 febrile neutropenia, Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding, any severe or life threatening AE or any AE or abnormality which impairs daily normal physiological functions, any treatment delay for 2 weeks or more due to adverse effects not related to PD. All events judged to be related by the Investigator to PD were excluded from the DLT definition.|Up to Day 21 of Cycle 1|Safety analysis set included all the subjects who received at least one administration of the trial medication.||Subjects|||Number
689919|NCT01453374|Secondary|Criminal Activity|Number of subjects who conducted any criminal activity during the study; assessed by review of criminal justice records and completion of the ASI and supplemental questionnaires|6 months|All subjects with non-missing data who received at least 1 injection of VIVITROL; 1 subject did not have any outcome data||participants with criminal activity|||Number
689920|NCT01453374|Secondary|Cocaine Use|Number of subjects who used cocaine during the study; assessed using the Addiction Severity Index (ASI) and urine drug tests|6 months|All subjects with non-missing data who received at least 1 injection of VIVITROL||participants who used cocaine|||Number
689921|NCT01453374|Secondary|Opioid Dependence|Meeting Diagnostic Statistical Manual, version IV, text revision (DSM-IV-TR) criteria for opioid dependence|7 months||||||
689922|NCT01453374|Secondary|Opioid Craving|Change from baseline in peak craving score 30 days post last injection; assessed using a 100 mm visual analog scale (VAS). Subjects are asked to make 1 slash mark through a point on a 100 mm line that best describes their greatest craving for opioids, whereby 0 represents no craving and 100 is more than ever.|8 months|All subjects with non-missing data who received at least 1 injection of VIVITROL||units on a scale||Standard Deviation|Mean
689923|NCT01453374|Secondary|Retention in the Community|Number of subjects who received all 6 post-release VIVITROL injections|6 months|All subjects who received at least 1 injection of VIVITROL||participants received all 7 injections|||Number
689924|NCT01453374|Secondary|Drug Abuse Treatment Program Entry|Number of subjects who participated in a drug treatment program during the study; assessed by review of Treatment Services Form.|7 months|All subjects with non-missing data who received at least 1 injection of VIVITROL; 1 subject did not have any outcome data||participants who entered drug treatment|||Number
689925|NCT01453374|Secondary|Opioid Overdose|"Number of subjects who overdosed during the study; measured through reported AEs of overdose and Opiate Overdose Form. The Form asks subjects if subjects overdosed during the past 30 days and, if so, how many times."|7 months|All subjects who received at least 1 injection of VIVITROL||participants who overdosed|||Number
689926|NCT01453374|Secondary|Opioid Use|Opioid use was obtained via self-report on the Addiction Severity Index (ASI) or via a urine drug test.|7 months|All subjects with non-missing data who had at least 1 injection of VIVITROL; 1 subject did not have any outcome data||participants with positive opioid use|||Number
689927|NCT01453374|Secondary|Incidence of Subject Re-incarceration|Subjects were considered to have had a re-incarceration, a sentence to jail and/or prison, if the subject had re-incarceration records in the official criminal justice records and/or via self-report.|7 months|All subjects with non-missing data who received at least 1 injection of VIVITROL; 1 subject did not have any outcome data||participants re-incarcerated|||Number
689928|NCT01453374|Primary|Incidence of Subject Re-arrest|Subjects were considered to have had a re-arrest for any new crime or probation/parole violation if the subject had re-arrest records in the official criminal justice records and/or via self-report.|7 months|All subjects with non-missing data who received at least 1 injection of VIVITROL; 1 subject did not have any outcome data||participants re-arrested|||Number
689976|NCT01453049|Secondary|Change From Baseline in Alanine Transaminase (ALT), Aspartate Aminotransferase (AST), Gamma-glutamyl Transpeptidase (GGT), Lactate Dehydrogenase (LDH), Alkaline Phosphatase (ALP), and Creatine Kinase (CK) at Week 24/EW|Blood samples of participants were collected for ALT, AST, GGT, LDH, ALP, and CK assessment. Change from Baseline in ALT, AST, GGT, LDH, ALP, and CK was calculated as the value at Week 24/EW minus the value at Baseline.|Baseline (Week 0) and Week 24/EW|Safety Population. Only those participants contributing data at the indicated time points were analyzed.||Units per liter (U/L)||Standard Deviation|Mean
689934|NCT01453296|Primary|Weighted Mean QTcF at Day 1 and Day 14 of the Respective Treatment Period|The electrocardiographic (ECG) parameter QT duration corrected using Fridericia’s formula (QTcF) was measured at Day 1 and Day 14 of the respective treatment period. hr=hour. Actual relative times were used for the calculation except where actual times were missing. If any actual times were missing, planned relative times were used for these observations. For 0-8 hr parameters, treatment, period, participant Baseline, and period Baseline were fitted as fixed effects, and participant was fitted as a random effect. For 0-2 hr parameters, treatment, period, day (1 and 14), participant Baseline, period Baseline, and treatment*day interaction were fitted as fixed effects, and participant was fitted as a random effect. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg (n=28).|Day 1 and Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||milliseconds||Standard Error|Least Squares Mean
689935|NCT01453296|Secondary|Ex-throat Dose (ETD) and ETD <2 Microns on Day 1 and Day 14 of the Respective Treatment Period|The ex-throat dose (ETD) and the “nominal ETD” is the mass (micrograms) of active investigational material that passes beyond the throat, nominal being the mean.The recorded inhalation profiles of the participants and the mouth-throat (oropharyngeal) models of the sizes that approximated to pharyngometry measurements of the participants were used in conjunction with the electronic Lung (eLung) for in vitro assessment. The eLung is a breathing simulator that replicates the selected inhalation profile with an active inhaler placed at the lips end of the selected ororpharyngeal model. After the dose is emitted from the inhaler, the analysis and assay of throat deposition and material passing beyond the throat was used to derive the nominal, minimum, and maximum predicted ETD and ETD <2 microns.|Day 1 and Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time point were analyzed.||micrograms||Standard Deviation|Mean
689936|NCT01453296|Secondary|Total Emitted Dose (TED) on Day 1 and Day 14 of the Respective Treatment Period|The total emitted dose (TED) is defined as the mass (micrograms) of the nominal dose that passes beyond the throat. The recorded inhalation profiles of the participants and the mouth-throat (oropharyngeal) models of the sizes that approximated to pharyngometry measurements of the participants were used in conjunction with the electronic Lung (eLung) for in vitro assessment. The eLung is a breathing simulator that replicates the selected inhalation profile with an active inhaler placed at the lips end of the selected ororpharyngeal model. After the dose is emitted from the inhaler, the analysis and assay of throat deposition and material passing beyond the throat was used to derive the nominal, minimum, and maximum predicted total emitted dose.|Day 1 and Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time point were analyzed. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.||micrograms||Standard Deviation|Mean
689937|NCT01453296|Secondary|Peak Pressure Drop on Day 1 and Day 14 of the Respective Treatment Period|During the inhalation profile assessment, participants inhaled through a mouthpiece from a device with a similar resistance to the dry powder inhaler used for this study. Peak pressure drop is defined as the maximum pressure drop (kilopascal [kPa]) achieved during inhalation across the resistance of the inhaler. The pressure drop during the inhalation was measured, and the inhalation profiles (pressure drop versus time profile) of the participants were obtained. The mean of the two inhalation profile measurements was calculated for each day (Days 1 and 14 of the respective treatment period), and used for subsequent modeling and prediction of dose emission attributes. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.|Day 1 and Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time point were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Kilopascal (kpa)||Standard Deviation|Mean
690063|NCT01451983|Primary|Total Brain Volume||Baseline|MRI acquisition was performed using Siemens Q4 TIM Trio 3 tesla scanner with standard 12-channel receive-only head coil. An 8-minute whole-brain T1-weighted inversion recovery turboflash (MPRAGE) was acquired. Volumetric measurements were obtained using the software suite Freesurfer. Not all participants received imaging due to age and impairment.||cubic centimeters||Standard Deviation|Mean
689938|NCT01453296|Secondary|Inhaled Volume on Day 1 and Day 14 of the Respective Treatment Period|"During the inhalation profile assessment, participants inhaled through a mouthpiece from a device with a similar resistance to the dry powder inhaler used for this study. Inhaled volume is defined as the volume of air (Liters) inhaled during the inhalation across the resistance of the inhaler.
The pressure drop during the inhalation was measured, and the inhalation profiles (pressure drop versus time profile) of the participants were obtained. The mean of the two inhalation profile measurements was used for each day (Days 1 and 14 of the respective treatment period), and the inhalaled volume was determined. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg."|Day 1 and Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time point were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Liters||Standard Deviation|Mean
689939|NCT01453296|Secondary|Inhalation Time on Day 1 and Day 14 of the Respective Treatment Period|During the inhalation profile assessment, participants inhaled through a mouthpiece from a device with a similar resistance to the dry powder inhaler used for this study. Inhalation time is defined as the duration of the inhalation(s) when inhaling across the resistance of the inhaler. The pressure drop during the inhalation was measured, and the inhalation profiles (pressure drop versus time profile) of the participants were obtained. The mean of the two inhalation profile measurements was used for each day (Days 1 and 14 of the respective treatment period), and the inhalation time was determined. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.|Day 1 and Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time point were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Seconds (sec)||Standard Deviation|Mean
689940|NCT01453296|Secondary|Average Flow Rate and Peak Inspiratory Flow Rate (PIFR) on Day 1 and Day 14 of the Respective Treatment Period|During the inhalation profile assessment, participants inhaled through a mouthpiece from a device with a similar resistance to the dry powder inhaler used for this study. Average flow rate is defined as the average inspiratory flow rate (Liters [L]/min) across the inhalation profile when inhaling across the resistance of the inhaler. PIFR is defined as the Peak Inspiratory Flow Rate (L/min) of the inhalation profile when inhaling across the resistance of the inhaler.The pressure drop during the inhalation was measured, and the inhalation profiles (pressure drop versus time profile) of the participants were obtained. The mean of the two inhalation profile measurements was used for each day (Days 1 and 14 of the respective treatment period), and the average flow rate and PIFR were determined. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.|Day 1 and Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time point were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Liters per minute (L/min)||Standard Deviation|Mean
689941|NCT01453296|Secondary|Oropharyngeal Volume on Day 1 and Day 14 of the Respective Treatment Period|During the pharyngometry assessment, participants inhaled through a wavetube, which had a mouthpiece with the same dimensions as the mouthpiece on the dry powder inhaler used for this study. This technique was used to measure the size of the throat and mouth (oropharynx) in the form of pharyngograms. Oropharyngeal volume is defined as the volume (centimeters cubed [cm^3]) of the mouth and throat estimated to be from the lips to the larynx. Pharyngometry data were recorded for each day (Days 1 and 14 of the respective treatment period) using the mean of four measurements (pharyngograms), and the average oropharyngeal cross-sectional area was calculated.|Day 1 and Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time point were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||cm^3||Standard Deviation|Mean
689942|NCT01453296|Secondary|Distance of Assessment on Day 1 and Day 14 of the Respective Treatment Period|During the pharyngometry assessment, participants inhaled through a wavetube, which had a mouthpiece with the same dimensions as the mouthpiece on the dry powder inhaler used for this study. This technique was used to measure the size of the throat and mouth (oropharynx) in the form of pharyngograms. Distance of assessment is defined as the distance (length measured in centimeters [cm]) estimated to be from the lips to the larynx. Pharyngometry data were recorded for each day (Days 1 and 14 of the respective treatment period) using the mean of four measurements (pharyngograms), and the average oropharyngeal cross-sectional area was calculated.|Day 1 and Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time point were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||centimeters (cm)||Standard Deviation|Mean
689943|NCT01453296|Secondary|Average Oropharyngeal Cross-sectional Area on Day 1 and Day 14 of the Respective Treatment Period|During the pharyngometry assessment, participants inhaled through a wavetube, which had a mouthpiece with the same dimensions as the mouthpiece on the dry powder inhaler used for the study. This technique was used to measure the size of the throat and mouth (oropharynx) in the form of pharyngograms. Pharyngometry data were recorded for each day (Day 1 and Day 14 of the respective treatment period) using the mean of four measurements (pharyngograms), and the average oropharyngeal cross-sectional area was calculated.|Day 1 and Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time point were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||centimeters squared (cm^2)||Standard Deviation|Mean
690064|NCT01451931|Secondary|Accuracy for Stones by Arm||Up to 6 month follow-up for stone passage|||Percent probability||95% Confidence Interval|Number
690065|NCT01451931|Secondary|Return Visits to ED or Hospital||6 months post-baseline|||Number of visits|||Number
690066|NCT01451931|Secondary|ED Length of Stay||Baseline visit excluding hospitalization|||Hours||Inter-Quartile Range|Median
689944|NCT01453296|Secondary|Blood Glucose and Potassium on Day 14 of the Respective Treatment Period|Blood glucose and potassium values were measured on Day 14 of the respective treatment period. Samples were collected at the following times: pre-dose; 10 minutes (min) and 30 min post-dose; and 1, 2, 4, 6, and 8 hours post-dose for participants who were >=20 kilograms and pre-dose; 10 min and 30 min post-dose; and 1, 2, and 4 hours post-dose for participants who were <=20 kilograms on Day 14 of the respective treatment period. . Weighted means were derived using the linear trapezoidal rule. Actual relative times were used for the calculation except where actual times were missing. If any actual times were missing, planned relative times were used for these observations. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg. Treatment and period were fitted as fixed effects and participant was fitted as a random effect.|Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
689945|NCT01453296|Secondary|Tmax, t1/2, and t at Day 14 of the Respective Treatment Period|tmax is defined as the time to reach the observed maximum concentration, t1/2 is defined as the time required to reduce the plasma concentration to one half its initial value, and t is defined as the time of the last observed quantifiable concentration on Day 14 of the respective treatment period. Samples were collected at the following times: pre-dose; 10 minutes (min) and 30 min post-dose; and 1, 2, 4, 6, and 8 hours post-dose for participants who were >=20 kilograms and pre-dose; 10 min and 30 min post-dose; and 1, 2, and 4 hours post-dose for participants who were <=20 kilograms on Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 49)|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the PK Population.||hours||Full Range|Median
689946|NCT01453296|Secondary|Cmax on Day 14 of the Respective Treatment Period|Cmax is defined as the maximum observed concentration on Day 14 of the respective treatment period. Samples were collected at the following times: pre-dose; 10 minutes (min) and 30 min post-dose; and 1, 2, 4, 6, and 8 hours post-dose for participants who were >=20 kilograms and pre-dose; 10 min and 30 min post-dose; and 1, 2, and 4 hours post-dose for participants who were <=20 kilograms on Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 49)|PK Population||picograms per milliliter (pg/mL)||95% Confidence Interval|Geometric Mean
689947|NCT01453296|Secondary|AUC(0-t) and AUC(0-8) on Day 14 of the Respective Treatment Period|Area under the concentration-time (AUC) curve from time zero (pre-dose) to the last time AUC(0-t) and from time zero to 8 hours AUC(0-8) of quantifiable concentration of VI on Day 14 of the respective treatment period was measured. Samples were collected at the following times: pre-dose; 10 minutes (min) and 30 min post-dose; and 1, 2, 4, 6, and 8 hours post-dose for participants who were >=20 kilograms and pre-dose; 10 min and 30 min post-dose; and 1, 2, and 4 hours post-dose for participants who were <=20 kilograms on Day 14 of the respective treatment period. Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Pharmacokinetic Population.|Day 14 of the respective treatment period (up to Study Day 49)|Pharmacokinetic (PK) Population: all participants in the All Subjects Population for whom a PK sample was obtained and analyzee. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).||picograms*hour per milliliter (pg*hr/mL)||95% Confidence Interval|Geometric Mean
689948|NCT01453296|Primary|Maximum QTcF at Day 1 and Day 14 of the Respective Treatment Period|The electrocardiographic (ECG) parameter QT duration corrected using Fridericia’s formula (QTcF) was measured at Day 1 and Day 14 of the respective treatment period. hr=hour. For 0-8 hr parameters, treatment, period, participant Baseline, and period Baseline were fitted as fixed effects, and participant was fitted as a random effect. For 0-2 hr parameters, treatment, period, day (1 and 14), participant Baseline, period Baseline, and treatment*day interaction were fitted as fixed effects, and participant was fitted as a random effect. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg (n=28).|Day 1 and Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||milliseconds||Standard Error|Least Squares Mean
689949|NCT01453296|Primary|Weighted Mean Heart Rate at Day 1 and Day 14 of the Respective Treatment Period|Heart rate (HR) was measured at Day 1 and Day 14 of the respective treatment period. hr=hour. Weighted means were derived using the linear trapezoidal rule. Actual relative times were used for the calculation except where actual times were missing. If any actual times were missing, planned relative times were used for these observations. For 0-8 hr parameters, treatment, period, participant Baseline, and period Baseline were fitted as fixed effects, and participant was fitted as a random effect. For 0-2 hr parameters, treatment, period, day (1 and 14), participant Baseline, period Baseline, and treatment*day interaction were fitted as fixed effects, and participant was fitted as a random effect. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg (n=28).|Day 1 and Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Beats per minute||Standard Error|Least Squares Mean
689950|NCT01453296|Primary|Maximum Heart Rate at Day 1 and Day 14 of the Respective Treatment Period|Heart rate (HR) was measured at Day 1 and Day 14 of the respective treatment period. hr=hour. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg (n=28).|Day 1 and Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Beats per minute||Standard Error|Least Squares Mean
689951|NCT01453296|Primary|Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Day 1, Day 8, and Day 14 of the Respective Treatment Period|SBP and DBP were measured at Day 1, Day 8, and Day 14 of the respective treatment period. PD=post-dose. Baseline is defined as the pre-dose measurement at Day 1 for the respective period. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg (n=28).|Day 1, Day 8, and Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Millimeters of mercury (mmHg)||Standard Deviation|Mean
689952|NCT01453296|Primary|Peak Expiratory Flow on Day 1, Day 8, and Day 14 of the Respective Treatment Period|Peak Expiratory Flow (PEF) is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF is calculated as the maximum of three readings taken at each timepoint for each participant. Baseline is defined as the pre-dose measurement at Day 1 for the respective period. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg (n=28).|Day 1, Day 8, and Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||liters/minute||Standard Deviation|Mean
689953|NCT01453296|Primary|Total Bilirubin, Direct Bilirubin, Creatinine, and Uric Acid Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of total bilirubin, direct bilirubin, creatinine, and uric acid at Day 14 of the respective treatment period. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.|Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Micromoles per liter (µmol/L)||Standard Deviation|Mean
689954|NCT01453296|Primary|Calcium, Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of calcium, chloride, carbon dioxide content/bicarbonate (CO2/BI), glucose, potassium, sodium, and urea/BUN at Day 14 of the respective treatment period. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.|Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Millimoles per liter (mmol/L)||Standard Deviation|Mean
689955|NCT01453296|Primary|Albumin and Total Protein Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of albumin and total protein at Day 14 of the respective treatment period. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.|Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Grams per liter||Standard Deviation|Mean
689956|NCT01453296|Primary|Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), and Gamma Glutamyl Transferase (GGT) Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of ALT, ALP, AST, and GGT at Day 14 of the respective treatment period. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.|Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population, Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||International units per liter (IU/L)||Standard Deviation|Mean
689957|NCT01453296|Primary|Mean Corpuscle Hemoglobin (MCH) Value at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of MCH at Day 14 of the respective treatment period. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.|Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time points were analyzed.||10^12 picograms (pg) per cell||Standard Deviation|Mean
689958|NCT01453296|Primary|Mean Corpuscle Volume (MCV) Value at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of MCV at Day 14 of the respective treatment period. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.|Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time points were analyzed.||10^15 femtoliters (fL) per cell||Standard Deviation|Mean
689959|NCT01453296|Primary|Hematocrit Value at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of hematocrit at Day 14 of the respective treatment period. Hematocrit is a measure of the percentage of the volume of the whole blood that is composed of red blood cells, as determined by separation of red blood cells from the plasma (usually by centrifugation). Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.|Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time points were analyzed.||proportion of 1||Standard Deviation|Mean
689989|NCT01453049|Secondary|Percent Change From Baseline in High Sensitivity C-reactive Protein (Hs-CRP) at Week 24/EW|Blood samples of participants were collected for hs-CRP assessment. CRP is a marker of inflammation. High levels of CRP predict the risk of heart disease and diabetes. Percent change from Baseline in hs-CRP was calculated as the value at Visit 8 (Wk 24)/ EW minus the value at Baseline divided by value at Wk 24/ EW multiplied by 100.|Baseline (Week 0) and Week 24/EW|FAS. Only those participants contributing data at the indicated time points were analyzed.||percent change||Full Range|Median
689961|NCT01453296|Primary|Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of hemoglobin and MCHC at Day 14 of the respective treatment period. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.|Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Grams per liter (g/L)||Standard Deviation|Mean
689962|NCT01453296|Primary|Basophil, Eosinophil, Lymphocyte, Monocyte, Total Neutrophil, Platelet, and White Blood Cell Count Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelets, and white blood cell (WBC) count at Day 14 of the respective treatment period. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.|Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||10^9 cells per liter (GI/L)||Standard Deviation|Mean
689963|NCT01453296|Primary|Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in deciding whether reporting is appropriate in other situations. Refer to the General AE/SAE module for a complete list of AEs and SAEs.|From the start of study medication until Week 11 (Visit 8)/Early Withdrawal|All Subjects Population: all participants who received at least one dose of study medication||Participants|||Number
689964|NCT01453166|Secondary|Blood Glucose|Change From Baseline in blood glucose|12 weeks|Participants who were evaluable at this time point were analyzed||mg/dl||Standard Error|Mean
689965|NCT01453166|Secondary|Waist Circumference|Change From Baseline in wais circumference|12 weeks|Participants who were evaluable at this time point were analyzed||cm||Standard Error|Mean
689966|NCT01453166|Primary|Total Cholesterol|Change From Baseline in total Cholesterol|12 weeks|Participants who were evaluable at this time point were analyzed.||mg/dl||Standard Error|Mean
689967|NCT01453166|Secondary|Weight|Change From Baseline in weight|12 weeks|Participants who were evaluable at this time point were analyzed||kg||Standard Error|Mean
689968|NCT01453166|Primary|Systolic Blood Pressure|Change From Baseline in systolic blood pressure|12 weeks|Participants who were evaluable at this time point were analyzed||mmHg||Standard Error|Mean
689969|NCT01453075|Primary|Effect of HSV-2 Suppression on HCV Viral Load.|Measure the change in serum HCV viral load at baseline and 12 weeks in patients who have chronic hepatitis C and HSV-2 infection who receive the 3 grams daily valacyclovir versus placebo|baseline; 12 weeks|Analyzed patients who completed study||log(IU/mL)||Standard Error|Mean
689970|NCT01453049|Secondary|Change From Baseline in Electrocardiogram (ECG) Data at Week 24/EW|PR, QT, QTc, RR, QRS, and QRS axis data were measured by ECG. The PR interval (int.) starts at the beginning of the atrial contraction and ends at the beginning of the ventricular contraction. QT (QT int.) and QTc (corrected QT int.) indicate how fast the ventricles are repolarized, becoming ready for a new cycle. The RR int. represents the duration of the ventricular cardiac cycle and is an indicator of ventricular rate. QRS (QRS duration) indicates how fast the ventricles depolarize. The QRS axis is an indicator of the electrical heart axis, which is an average of all heart depolarization.|Baseline (Week 0) and Week 24/EW|Safety Population. Only those participants contributing data at the indicated time points were analyzed.||milliseconds (msec)||Standard Deviation|Mean
689971|NCT01453049|Secondary|Change From Baseline in Electrocardiogram (ECG) Assessment of Heart Rate at Week 24/EW|Electrocardiograms of the participants were taken for the evaluation of heart rate. Change from Baseline in heart rate was calculated as the value at Week 24/EW minus the value at Baseline.|Baseline (Week 0) and Week 24/EW|Safety Population. Only those participants contributing data at the indicated time points were analyzed.||bpm||Standard Deviation|Mean
689972|NCT01453049|Secondary|Change From Baseline in Weight at Week 24/EW|The weight of the participants was measured. Change from Baseline in weight was calculated as the value at Week 24/EW minus the value at Baseline.|Baseline (Week 0) and Week 24/EW|Safety Population. Only those participants contributing data at the indicated time points were analyzed.||kilograms (kg)||Standard Deviation|Mean
689973|NCT01453049|Secondary|Change From Baseline in Heart Rate at Week 24/EW|The heart rate of the participants was measured. Change from Baseline in heart rate was calculated as the value at Week 24/EW minus the value at Baseline.|Baseline (Week 0) and Week 24/EW|Safety Population. Only those participants contributing data at the indicated time points were analyzed.||beats per minute (bpm)||Standard Deviation|Mean
689974|NCT01453049|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 24/EW|The blood pressure of the participants was measured. Change from Baseline in SBP and DBP was calculated as the value at Weeks 24/EW minus the value at Baseline.|Baseline (Week 0) and Week 24/EW|Safety Population. Only those participants contributing data at the indicated time points were analyzed.||Millimeters of mercury (mmHg)||Standard Deviation|Mean
689975|NCT01453049|Secondary|Change From Baseline in Total Bilirubin (TB), Direct Bilirubin (DB), Creatinine, and Uric Acid (UC) at Week 24/EW|Blood samples of participants were collected for TB, DB, creatinine, and UC assessment. Change from Baseline in TB, DB, creatinine, and UC was calculated as the value at Week 24/EW minus the value at Baseline.|Baseline (Week 0) and Week 24/EW|Safety Population. Only those participants contributing data at the indicated time points were analyzed.||Micromoles per liter (mcmol/L)||Standard Deviation|Mean
690067|NCT01451931|Primary|Cumulative Radiation Exposure||Baseline plus 6 months post-baseline|||mSv||Standard Deviation|Mean
695701|NCT01386632|Secondary|Relative Toxicities During Treatment for Locally Advanced Head and Neck Squamous Cell Carcinoma Patients Receiving Concurrent Cisplatin, Radiation Therapy, and DCA.||End of treatment||||||
689977|NCT01453049|Secondary|Change From Baseline in Mean Corpuscular Hemoglobin (MCH) at Week 24/EW|Blood samples of participants were collected for MCH assessment. Change from Baseline in MCH was calculated as the value at Week 24/EW minus the value at Baseline. MCH is the average amount of hemoblobin inside a RBC expressed in picograms. MCH is calculated by dividing the hemoglobin concentration in grams per deciliter by the RBC count in millions per microliter, then multiplying by 10. MCH is one of the three main RBC indices which are helpful to determine the cause of anemia.|Baseline (Week 0) and Week 24/EW|Safety Population. Only those participants contributing data at the indicated time points were analyzed.||Picograms (pg) per cell||Standard Deviation|Mean
689978|NCT01453049|Secondary|Change From Baseline in Mean Corpuscular Volume (MCV) at Week 24/EW|Blood samples of participants were collected for MCV assessment. Change from Baseline in MCV was calculated as the value at Week 24/EW minus the value at Baseline. MCV is the average size of the red blood cells expressed in femtoliters. MCV is calculated by dividing the hematocrit (as percent) by the RBC count in millions per microliter of blood, then multiplying by 10. MCV is one of the three main RBC indices that are helpful in determining the cause of anemia.|Baseline (Week 0) and Week 24/EW|Safety Population. Only those participants contributing data at the indicated time points were analyzed.||Femtoliters (FL) per cell||Standard Deviation|Mean
689979|NCT01453049|Secondary|Change From Baseline in Hemoglobin (HE), Mean Corpuscular Hemoglobin Concentration (MCHC), Total Protein (TP), and Albumin at Week 24/EW|Blood samples of participants were collected for HE, MCHC, and TP assessment. Change from Baseline in HE, MCHC, and TP was calculated as the value at Week 24/EW minus the value at Baseline.|Baseline (Week 0) and Week 24/EW|Safety Population. Only those participants contributing data at the indicated time points were analyzed.||Grams per liter (G/L)||Standard Deviation|Mean
689980|NCT01453049|Secondary|Change From Baseline in Hematocrit (HCT) at Week 24/EW|Blood samples of participants were collected for HCT assessment. Change from Baseline in HCT was calculated as the value at Week 24/EW minus the value at Baseline. HCT is measured as the percentage of the volume of whole blood that is made up of red blood cells.|Baseline (Week 0) and Week 24/EW|Safety Population. Only those participants contributing data at the indicated time points were analyzed.||percentage of volume of whole blood||Standard Deviation|Mean
689981|NCT01453049|Secondary|Change From Baseline in Lymphocytes, Monocytes, Neutrophils, Eosinophils, and Basophils at Week 24/EW|Blood samples of participants were collected for lymphocyte, monocyte, neutrophil, eosinophil, and basophil assessment. Change from Baseline in lymphocytes, monocytes, neutrophils, eosinophils, and basophils was calculated as the value at Week 24/EW minus the value at Baseline.|Baseline (Week 0) and Week 24/EW|Safety Population. Only those participants contributing data at the indicated time points were analyzed.||percent of WBC count||Standard Deviation|Mean
689982|NCT01453049|Secondary|Change From Baseline in Red Blood Cell (RBC) Count at Week 24/EW|Blood samples of participants were collected for RBC count assessment. Change from Baseline in RBC count was calculated as the value at Week 24/EW minus the value at Baseline.|Baseline (Week 0) and Week 24/EW|Safety Population. Only those participants contributing data at the indicated time points were analyzed.||Pico per liter (10^12/ L) cells||Standard Deviation|Mean
689983|NCT01453049|Secondary|Change From Baseline in White Blood Cell (WBC) Count and Platelet Count at Week 24/EW|Blood samples of participants were collected for WBC count and platelet count assessment. Change from Baseline in WBC count and platelet count was calculated as the value at Week 24/EW minus the value at Baseline.|Baseline (Week 0) and Week 24/EW|Safety Population. Only those participants contributing data at the indicated time points were analyzed.||Giga per liter (10^9/L) cells||Standard Deviation|Mean
689984|NCT01453049|Secondary|Number of Participants With a Bone Fracture|Participants with a break in the continuity (fracture) of the bone were evaluated.|Week 24/EW|Safety Population. Only those participants contributing data at the indicated time points were analyzed.||participants|||Number
689985|NCT01453049|Secondary|Number of Hypoglycemic Events|A hypoglycemic event is a condition that occurs when the blood glucose is below 70 mg/dL or 4 mmol/L. All participants, participants with HbA1c <7%, or who achieved a decrease of >= 0.7% from Baseline at Week 24 (HbA1c responders); and participants who had a >=1.7 mmol/L decrease from Baseline FPG or who achieved a FPG <6.1 mmol/L at Week 24 (FPG responders) were evaluated.|Week 24/EW|Safety Population. Only those participants contributing data at the indicated time points were analyzed.||Hypoglycemic events|||Number
689986|NCT01453049|Secondary|Number of Participants With Hypoglycemic Events|Blood samples of participants were collected for the assessment of blood glucose levels. Hypoglycemia is a condition that occurs when the blood glucose is below 70 mg/dL or 4 mmol/L. All participants; participants with HbA1c <7%, or who achieved a decrease of >= 0.7% from Baseline at Week 24 (HbA1c responders); and participants who had a >=1.7 mmol/L decrease from Baseline FPG or who achieved a FPG <6.1 mmol/L at Week 24 (FPG responders) were evaluated.|Week 24/EW|Safety Population. Only those participants contributing data at the indicated time points were analyzed.||participants|||Number
689987|NCT01453049|Secondary|Change From Baseline in Adjusted Diabetes Quality of Life (A-DQOL) Scores at Week 24/EW|In diabetic participants, QOL, anxiety, and depression were measured by the A-DQOL scale . There are 46 core items (10 additional items for adolescents) and 4 major dimensions: treatment satisfaction, treatment impact, worry about long-term complications, and worry about social/vocational issues. Participants respond to all items on a 5-point Likert scale: 1, no impact, no worries, or always satisfied; 5, always affected, always worried, or never satisfied. The total score is a sum of the individual scores of all 46 items (range of 46 to 230); a lower score indicates a better QOL.|Baseline (Week 0) and Week 24/EW|FAS. Only those participants contributing data at the indicated time points were analyzed.||scores on a scale||Standard Deviation|Mean
689988|NCT01453049|Secondary|Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) at Week 24/EW|EQ-5D is used as a measure of health outcome and includes single-item measures (coded on a 3-point scale [1, no problems; 2, some problems; 3, severe problems]) of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The instrument includes a global rating of current health using a visual analog scale (VAS): 0 (worst imaginable) to 100 (best imaginable). Health states may be converted to a single summary index by applying a formula that attaches values to each of the levels in each dimension. The index scale is -0.111 to 1. A lower index indicates worse health.|Baseline (Week 0) and Week 24/EW|FAS. Only those participants contributing data at the indicated time points were analyzed.||scores on a scale||Standard Deviation|Mean
695702|NCT01386632|Secondary|Relative Toxicities for Locally Advanced Head and Neck Squamous Cell Carcinoma Patients Receiving Concurrent Cisplatin, Radiation Therapy, and DCA.||3 months||||||
689991|NCT01453049|Secondary|Change From Baseline in the Ratio of TC/HDL-C and LDL-C/HDL-C at Week 24/EW|Blood samples of participants who had fasted for 12 to 14 hours were collected for lipid profile (TC, HDL-C and LDL-C) assessment. The ratio of TC/HDL-C and LDL-C/HDL-C was calculated. Change from Baseline in the ratio of TC/HDL-C and LDL-C/HDL-C was calculated as the value at Week 24/EW minus the value at Baseline. For TC/HDL-C, the numerator is TC, and the denominator is HDL-C. For LDL-C/HDL-C, the numerator is LDL-C, and the denominator is HDL-C.|Baseline (Week 0) and Week 24/EW|FAS. Only those participants contributing data at the indicated time points were analyzed.||ratio||Standard Deviation|Mean
689992|NCT01453049|Secondary|Change From Baseline in Blood Urea Nitrogen (BUN), Sodium, Potassium, Chloride, Calcium, and Phosphorus at Week 24/EW|Blood samples of participants were collected for BUN and electrolyte (sodium, potassium, chloride, calcium, and phosphorus) assessment. The electrolyte balance asseses the condition of the heart and the kidneys, and BUN assesses the condition of the kidneys. Change from Baseline in BUN, sodium, potassium, chloride, calcium, and phosphorus was calculated as the value at Week 24/EW minus the value at Baseline.|Baseline (Week 0) and Week 24/EW|Safety Population: all participants who received at least one dose of study medication. Only those participants contributing data at the indicated time points were analyzed.||mmol/L||Standard Deviation|Mean
689993|NCT01453049|Secondary|Change From Baseline in Total Cholesterol (TC), High Density Lipoprotein-cholesterol (HDL-C), Low Density Lipoprotein-cholesterol (LDL-C), and Triglyceride (TG) at Week 24/EW|Blood samples of participants who had fasted for 12 to 14 hours were collected for lipid profile (TC, HDL-C, LDL-C, TG) assessment. The lipid profile asesses the risk of heart disease. Change from Baseline in TC, HDL-C, LDL-C, and TG was calculated as the value at Week 24)/EW minus the value at Baseline.|Baseline (Week 0) and Week 24/EW|FAS. Only those participants contributing data at the indicated time points were analyzed.||mmol/L||Standard Deviation|Mean
689994|NCT01453049|Secondary|Number of Participants at Various Dose Levels at Week 24/EW|The number of participants at the different dose levels at Week 24/EW was recorded. The different dose levels for Rosi + Glim are: Dose level 1, Rosi 4 mg + Glim 1 mg; Dose level 2, Rosi 4 mg + Glim 2 mg; Dose level 3, Rosi 4 mg + Glim 4 mg. The different dose levels for Glim are: Dose level 1, Glim 1 mg; Dose level 2, Glim 2 mg; Dose level 3, Glim 4 mg.|Week 24/EW|FAS. Only those participants contributing data at the indicated time points were analyzed. Data were missing for one participant in the rosiglitazone+glimepiride FDC arm.||participants|||Number
689995|NCT01453049|Secondary|Change From Baseline in Homeostasis Model Assessment Beta-cell Function (HOMA-B) at Week 24/EW|Blood samples of participants who had fasted for 12 to 14 hours were collected for fasting glucose (FG) and insulin (FI) assessment. The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance (a condition in which natural hormone insulin becomes less effective in lowering blood sugars) and beta-cell (specialized cells in the pancreas producing insulin) function. HOMA-B is calculated using the following mathematical model to predict glucose and insulin concentrations=(20*FI[mU/ml])/(FG[mmol/l]-3.5).|Baseline (Week 0) and Week 24/EW|FAS. Only those participants contributing data at the indicated time points were analyzed.||Ratio: 20*FI (num.); FG-3.5 (denom.)||Standard Deviation|Mean
689996|NCT01453049|Secondary|Change From Baseline in Homeostasis Model Assessment Sensitivity (HOMA-S) at Week 24/EW|Blood samples of participants who had fasted for 12-14 hours were collected for fasting glucose (FG) and insulin (FI) assessment. The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance (a condition in which natural hormone insulin becomes less effective in lowering blood sugars) and beta-cell (specialized cells in the pancreas producing insulin) function. HOMA-S is calculated using the following model to predict glucose and insulin concentrations=(FI[milliunits (mU)/milliliter (ml)]*FG [millimoles per liter (mmol/l)])/22.5. numerator, num.; denominator, denom.|Baseline (Week 0) and Week 24/EW|FAS. Only those participants contributing data at the indicated time points were analyzed.||Ratio: FI*FG (num.); 22.5 (denom.)||Standard Deviation|Mean
689997|NCT01453049|Secondary|Change From Baseline in Fasting Proinsulin and Insulin at Week 24/Early Withdrawal (EW)|Blood samples of participants who had fasted for 12-14 hours were collected for fasting proinsulin (precursor of insulin) and insulin assessment. Preproinsulin is sequentially processed via proinsulin, through intermediate proteolytic cleavage products, to insulin and C-peptide before release from the beta cell granule by exocytosis. Elevated levels of proinsulin are considered indicative of beta cell dysfunction. Insulin is a hormone that regulates carbohydrate and fat metabolism in the body. Change from Baseline was calculated as the value at Week 24/ EW minus the value at Baseline (Week 0).|Baseline (Week 0) and Week 24/EW|FAS. Only those participants contributing data at the indicated time points were analyzed.||Picomoles per liter (pmol/L)||Standard Deviation|Mean
689998|NCT01453049|Secondary|Number of Participants Who Achieved HbA1c <7%, HbA1c <=6.5%, or Who Achieved a Decrease of >=0.7% From Baseline|Blood samples of participants were collected for HbA1c assessment.|Baseline (Week 0) and Week 24 (LOCF)|FAS. Missing values were imputed using the LOCF method, i.e., the last available observation was used to estimate subsequent missing data points. Only those participants contributing data at the indicated time points were analyzed.||participants|||Number
689999|NCT01453049|Secondary|Number of FPG Responders and Non-responders|Blood samples of participants were collected for FPG assessment. FPG responders are definded as participants who had a >=1.7 mmol/L decrease from Baseline FPG or who achieved a FPG level < 6.1 mmol/L at Week 24 (LOCF).|Baseline (Week 0) and Week 24 (LOCF)|FAS. Missing values were imputed using the LOCF method, i.e., the last available observation was used to estimate subsequent missing data points. Only those participants contributing data at the indicated time points were analyzed.||participants|||Number
690000|NCT01453049|Secondary|Number of HbA1c Responders and Non-responders|Blood samples of participants were collected for HbA1c assessment. HbA1c responders were defined as participants who had achieved HbA1c <7%, or who achieved a decrease of >= 0.7% from Baseline at Week 24 (LOCF).|Baseline (Week 0) and Week 24 (LOCF)|FAS. Missing values were imputed using the LOCF method, i.e., the last available observation was used to estimate subsequent missing data points. Only those participants contributing data at the indicated time points were analyzed.||participants|||Number
690068|NCT01451931|Primary|High Risk Diagnosis With Complication|Missed or delayed diagnosis of appendicitis, pneumonia with sepsis, diverticulitis, abdominal aortic aneurysm with rupture, mesenteric ischemia with bowel perforation, renal infarction, stone with renal abscess, urosepsis/pyelonephritis with bacteremia, ovarian torsion with necrosis related to randomization and due to imaging modality.|30 days from baseline|||participants|||Number
729644|NCT00381940|Secondary|Overall Response Rate|Overall response includes complete response and partial response.|After 2 cycles and 4 cycles||||||
690001|NCT01453049|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Blood samples of participants were collected for FPG assessment. The FPG test, also known as the fasting blood sugar test, measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. Change from Baseline in FBG was calculated as the value at Week 24 minus the value at Baseline.|Baseline (Week 0) and Week 24|FAS. Missing values were imputed using the Last Observation Carried Forward (LOCF) method, i.e., the last available observation was used to estimate subsequent missing data points. Only those participants contributing data at the indicated time points were analyzed.||Millimoles per liter (mmol/L)||Standard Deviation|Mean
690002|NCT01453049|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|Blood samples of participants were collected for HbA1c assessment. HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The American Diabetes Association has recommended an HbA1c value below 53 millimoles per mole (mmol/mol) (7.0%) for most participants. Change from Baseline in HbA1c was calculated as the value at Week 24 minus the value at Baseline.|Baseline (Week 0) and Week 24|Full Analysis Set (FAS): all randomized participants who received >=1 dose of study medication and had >=1 post-Baseline efficacy assessment. Missing values were imputed using Last Observation Carried Forward (used to estimate subsequent missing data points). Only those participants contributing data at the indicated time points were analyzed.||Percent of total hemoglobin||Standard Deviation|Mean
690003|NCT01453036|Primary|Helicobacter Pylori Eradication Rate|Eradication was determined by the C13-urea breath test 6 to 8 weeks after the eradication therapy when PPIs had not been used for at least 2 weeks.|8 weeks|Each convential AOC, AOM group : 308 patients Mutation test gorup : H. pylori was not detected by PCR 90 patient , total 218 patient predicted prevalence – 50%, expected dropout rate -15%, predicted eradication rate – 80%, significance level - 0.05, statistical power - 90%||percentage of participants||95% Confidence Interval|Number
690004|NCT01453023|Secondary|Ex-throat Dose (ETD) and ETD <2 Microns on Day 14 of the Respective Treatment Period|The ex-throat dose (ETD) and the “nominal ETD” is the mass (micrograms) of active investigational material that passes beyond the throat, nominal being the mean. The recorded inhalation profiles of the participants and the mouth-throat (oropharyngeal) models of the sizes that approximated to pharyngometry measurements of the participants were used in conjunction with the electronic Lung (eLung) for in vitro assessment. The eLung is a breathing simulator that replicates the selected inhalation profile with an active inhaler placed at the lips end of the selected ororpharyngeal model. After the dose is emitted from the inhaler, the analysis and assay of throat deposition and material passing beyond the throat was used to derive the nominal, minimum, and maximum predicted ETD and ETD <2 microns.|Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||micrograms||Standard Deviation|Mean
690005|NCT01453023|Secondary|Total Emitted Dose (TED) on Day 14 of the Respective Treatment Period|The total emitted dose (TED) is defined as the mass (micrograms) of the nominal dose that passes beyond the throat. The recorded inhalation profiles of the participants and the mouth-throat (oropharyngeal) models of the sizes that approximated to pharyngometry measurements of the participants were used in conjunction with the electronic Lung (eLung) for in vitro assessment. The eLung is a breathing simulator that replicates the selected inhalation profile with an active inhaler placed at the lips end of the selected ororpharyngeal model. After the dose is emitted from the inhaler, the analysis and assay of throat deposition and material passing beyond the throat was used to derive the nominal, minimum, and maximum predicted total emitted dose.|Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||micrograms||Standard Deviation|Mean
690006|NCT01453023|Secondary|Peak Pressure Drop on Days 1 and 14 of the Respective Treatment Period|During the inhalation profile assessment, participants inhaled through a mouthpiece from a device with a similar resistance to the dry powder inhaler used for this study. Peak pressure drop is defined as the maximum pressure drop (kilopascal [kPa]) achieved during inhalation across the resistance of the inhaler. The pressure drop during the inhalation was measured, and the inhalation profiles (pressure drop versus time profile) of the participants were obtained. The mean of the two inhalation profile measurements was calculated for each day (Days 1 and 14 of the respective treatment period), and used for subsequent modeling and prediction of dose emission attributes.|Day 1 and Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Kilopascal (kpa)||Standard Deviation|Mean
690007|NCT01453023|Secondary|Inhaled Volume on Days 1 and 14 of the Respective Treatment Period|"During the inhalation profile assessment, participants inhaled through a mouthpiece from a device with a similar resistance to the dry powder inhaler used for this study. Inhaled volume is defined as the volume of air (Liters) inhaled during the inhalation across the resistance of the inhaler.
The pressure drop during the inhalation was measured, and the inhalation profiles (pressure drop versus time profile) of the participants were obtained. The mean of the two inhalation profile measurements was used for each day (Days 1 and 14 of the respective treatment period), and the inhalaled volume was determined."|Day 1 and Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Liters||Standard Deviation|Mean
690069|NCT01451814|Primary|7-day Point Prevalence Smoking Abstinence at 26 Weeks|Biochemically verified abstinence from smoking over the past 7 days|26 Weeks|||percentage of participants abstinent|||Number
690070|NCT01451814|Primary|7-day Point Prevalence Smoking Abstinence at 16 Weeks|Biochemically verified abstinence from smoking over the past 7 days|16 Weeks|||percentage of participants abstinent|||Number
729645|NCT00381940|Secondary|Toxicity||4 weeks following completion of therapy||||||
690008|NCT01453023|Secondary|Inhalation Time on Days 1 and 14 of of the Respective Treatment Period|During the inhalation profile assessment, participants inhaled through a mouthpiece from a device with a similar resistance to the dry powder inhaler used for this study. Inhalation time is defined as the duration of the inhalation(s) when inhaling across the resistance of the inhaler. The pressure drop during the inhalation was measured, and the inhalation profiles (pressure drop versus time profile) of the participants were obtained. The mean of the two inhalation profile measurements was used for each day (Days 1 and 14 of the respective treatment period), and the inhalation time was determined.|Day 1 and Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Seconds (sec)||Standard Deviation|Mean
690009|NCT01453023|Secondary|Average Flow Rate and Peak Inspiratory Flow Rate (PIFR) on Day 1 and Day 14 of the Respective Treatment Period|During the inhalation profile assessment, participants inhaled through a mouthpiece from a device with a similar resistance to the dry powder inhaler used for this study. Average flow rate is defined as the average inspiratory flow rate (Liters [L]/min) across the inhalation profile when inhaling across the resistance of the inhaler. PIFR is defined as the Peak Inspiratory Flow Rate (L/min) of the inhalation profile when inhaling across the resistance of the inhaler.The pressure drop during the inhalation was measured, and the inhalation profiles (pressure drop versus time profile) of the participants were obtained. The mean of the two inhalation profile measurements was used for each day (Days 1 and 14 of the respective treatment period), and the average flow rate and PIFR were determined.|Day 1 and Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Liters per minute (L/min)||Standard Deviation|Mean
690010|NCT01453023|Secondary|Oropharyngeal Volume on Day 1 and Day 14 of the Respective Treatment Period|During the pharyngometry assessment, participants inhaled through a wavetube, which had a mouthpiece with the same dimensions as the mouthpiece on the dry powder inhaler used for this study. This technique was used to measure the size of the throat and mouth (oropharynx) in the form of pharyngograms. Oropharyngeal volume is defined as the volume (cm^3) of the mouth and throat estimated to be from the lips to the larynx. Pharyngometry data were recorded for each day (Days 1 and 14 of the respective treatment period) using the mean of four measurements (pharyngograms), and the average oropharyngeal cross-sectional area was calculated.|Day 1 and Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Liters per minute (L/min)||Standard Deviation|Mean
690011|NCT01453023|Secondary|Distance of Assessment on Day 1 and Day 14 of the Respective Treatment Period|During the pharyngometry assessment, participants inhaled through a wavetube, which had a mouthpiece with the same dimensions as the mouthpiece on the dry powder inhaler used for this study. This technique was used to measure the size of the throat and mouth (oropharynx) in the form of pharyngograms. Distance of assessment is defined as the distance (length measured in centimeters [cm]) estimated to be from the lips to the larynx. Pharyngometry data were recorded for each day (Days 1 and 14 of the respective treatment period) using the mean of four measurements (pharyngograms), and the average oropharyngeal cross-sectional area was calculated.|Day 1 and Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||centimeters (cm)||Standard Deviation|Mean
690012|NCT01453023|Secondary|Average Oropharyngeal Cross-sectional Area on Day 1 and Day 14 of the Respective Treatment Period|During the pharyngometry assessment, participants inhaled through a wavetube, which had a mouthpiece with the same dimensions as the mouthpiece on the dry powder inhaler used for the study. This technique was used to measure the size of the throat and mouth (oropharynx) in the form of pharyngograms. Pharyngometry data were recorded for each day (Day 1 and Day 14 of the respective treatment period) using the mean of four measurements (pharyngograms), and the average oropharyngeal cross-sectional area was calculated.|Day 1 and Day 14 of the respective treatment period (up to Study Day X)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||centimeters squared (cm^2)||Standard Deviation|Mean
690013|NCT01453023|Secondary|Serum Cortisol (SC) Weighted Mean (0–12 Hours) on Day 14 of the Respective Treatment Period|"SC weighted mean was determined for each participant over the time period of 0–12 hours on Day 14 of the respective treatment period. SC weighted mean was derived by dividing the area under the concentration-time curve (AUC; defined as thearea under the concentration-time curve from time zero up to 24 hours) by the sample collection time interval. The sample collection time interval is defined as the difference between the time of the last cortisol sample and the time of the first cortisol sample. Samples were collected at the following time points: 0 (first blood draw/pre-dose); 2, 4, 8, and 12 hours (relative to the 0 time point). Weighted means were derived using the linear trapezoidal rule. Actual relative times were used for the calculation except where actual times were missing. If any actual times were missing, planned relative time were used for these observations. Treatment and period were fitted as fixed effects and participant was fitted as a random effect."|Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed.||nanomoles per Liter||95% Confidence Interval|Geometric Mean
690071|NCT01451814|Primary|7-day Point Prevalence Smoking Abstinence at 8 Weeks|Biochemically verified abstinence from smoking over the past 7 days|8 weeks|||percentage of participants abstinent|||Number
690140|NCT01451398|Secondary|Incidence of Total Hypoglycemia|Hypoglycemia, defined as blood glucose <= 70 mg/dL or in absence of blood glucose, symptoms that are resolved by the administration of carbohydrates.|Baseline to Week 24|Safety population||percentage of participants|||Number
690014|NCT01453023|Secondary|Blood Glucose and Potassium Values on Day 14 of the Respective Treatment Period|Blood glucose and potassium values were measured on Day 14 of the respective treatment period. Samples were collected at the following times: pre-dose; 10 minutes (min) and 30 min post-dose; and 1, 2, and 4 hours post-dose. Weighted means were derived using the linear trapezoidal rule. Actual relative times were used for the calculation except where actual times were missing. If any actual times were missing, planned relative time were used for these observations. Treatment and period were fitted as fixed effects and participant was fitted as a random effect.|Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Millimoles per liter (mmol/L)||95% Confidence Interval|Least Squares Mean
690015|NCT01453023|Secondary|Tmax and Tlast of VI on Day 1 of the Respective Treatment Period|tmax is defined as the time to reach the observed maximum VI concentration, and tlast is defined as the time of the last observed quantifiable VI concentration on Day 14 of the respective treatment period. Samples were collected at the following times: pre-dose; 10 minutes (min) and 30 min post-dose; and 1, 2, and 4 hours post-dose.|Day 14 of the respective treatment period (up to Study Day 63)|VI PK Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the VI PK Population.||hours||Full Range|Median
690016|NCT01453023|Secondary|Cmax of VI on Day 14 of the Respective Treatment Period|Cmax is defined as the maximum observed concentration of VI on Day 14 of the respective treatment period. Samples were collected at the following times: pre-dose; 10 minutes (min) and 30 min post-dose; and 1, 2, and 4 hours post-dose.|Day 14 of the respective treatment period (up to Study Day 63)|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.||picograms per milliliter (pg/mL)||95% Confidence Interval|Geometric Mean
690017|NCT01453023|Secondary|AUC(0-t) and AUC(0-4) of VI on Day 14 of the Respective Treatment Period|Area under the concentration-time (AUC) curve from time zero (pre-dose) to the last time AUC(0-t) and from time zero to 4 hours AUC(0-4) of quantifiable concentration of VI on Day 14 of the respective treatment period was measured. Samples were collected at the following times: pre-dose; 10 minutes (min) and 30 min post-dose; and 1, 2, and 4 hours post-dose. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the VI PK Population.|Day 14 of the respective treatment period (up to Study Day 63)|VI PK Population: participants in the All Subjects Population for whom a PK sample was obtained and analyzed for VI.||picograms*hour per milliliter (pg*hr/mL)||95% Confidence Interval|Geometric Mean
690018|NCT01453023|Secondary|Tmax and Tlast of FF on Day 14 of the Respective Treatment Period|tmax is defined as the time to reach the observed maximum concentration, and tlast is defined as the time of the last observed quantifiable concentration on Day 14 of the respective treatment period. Samples were collected at the following times: pre-dose; 10 minutes (min) and 30 min post-dose; and 1, 2, and 4 hours post-dose.|Day 14 of the respective treatment period (up to Study Day 63)|FF PK Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the PK Population.||hours||Full Range|Median
690019|NCT01453023|Secondary|Cmax of FF on Day 14 of the Respective Treatment Period|Cmax is defined as the maximum observed concentration of FF on Day 14 of the respective treatment period. Samples were collected at the following times: pre-dose; 10 minutes (min) and 30 min post-dose; and 1, 2, and 4 hours post-dose.|Day 14 of the respective treatment period (up to Study Day 63)|FF PK Population. Only those participants available at the specified time points were analyzed.||picograms per milliliter (pg/mL)||95% Confidence Interval|Geometric Mean
690020|NCT01453023|Secondary|AUC(0-t) and AUC(0-4) of FF on Day 14 of the Respective Treatment Period|Area under the concentration-time (AUC) curve from time zero (pre-dose) to the last time AUC(0-t) and from time zero to 4 hours AUC(0-4) of quantifiable concentration of FF on Day 14 of the respective treatment period was measured. Samples were collected at the following times: pre-dose; 10 minutes (min) and 30 min post-dose; and 1, 2, and 4 hours post-dose. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the PK Population.|Day 14 of the respective treatment period (up to Study Day 63)|FF Pharmacokinetic (PK) Population: participants in the All Subjects Population for whom a PK sample was obtained and analyzed for FF.||picograms*hour per milliliter (pg*hr/mL)||95% Confidence Interval|Geometric Mean
690021|NCT01453023|Primary|Maximum QTcF at Day 1 and Day 14 of the Respective Treatment Period|QTcF is the QT domain corrected for heart rate by Fridericia’s formula. Treatment, period, day (1 and 14), participant Baseline, period Baseline, and treatment*day interaction were fitted as fixed effects, and participant was fitted as a random effect.|Day 1 and Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||milliseconds||Standard Error|Least Squares Mean
690022|NCT01453023|Primary|Change From Baseline in Heart Rate at Day1 and Day 14 of the Respective Treatment Period|Heart rate (HR) was measured at Day 1 and Day 14 of the respective treatment period. hr=hour. Baseline is defined as the pre-dose measurement at Day 1. Change from Baseline was calculated as the Day 14 value minus the Baseline value. Treatment, period, day (1 and 14), participant Baseline, period Baseline, and treatment*day interaction were fitted as fixed effects, and participant was fitted as a random effect.|Day 1 and Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Beats per minute||Standard Error|Least Squares Mean
690023|NCT01453023|Primary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Day 1 and Day 14 of the Respective Treatment Period|SBP and DBP were measured at Day 1 and Day 14 of the respective treatment period. Baseline is defined as the pre-dose measurement at Day 1. Change from Baseline was calculated as the Day 14 value minus the Baseline value.|Day 1 and Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Millimeters of mercury (mmHg)||Standard Deviation|Mean
690024|NCT01453023|Primary|Peak Expiratory Flow on Day 1 and Day 14 of the Respective Treatment Period|Peak Expiratory Flow (PEF) is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF is calculated as the maximum of three readings taken at each timepoint for each participant. Baseline is defined as the maximum pre-dose measurement at Day 1 for each period.|Day 1 and Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population, Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||liters/minute||Standard Deviation|Mean
690025|NCT01453023|Primary|Total Bilirubin, Direct Bilirubin, Creatinine, and Uric Acid Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of total bilirubin, direct bilirubin, creatinine, and uric acid at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population, Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Micromoles per liter (µmol/L)||Standard Deviation|Mean
690026|NCT01453023|Primary|Calcium, Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of calcium, chloride, carbon dioxide content/bicarbonate (CO2/BI), glucose, potassium, sodium, and urea/BUN at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population, Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Millimoles per liter (mmol/L)||Standard Deviation|Mean
690027|NCT01453023|Primary|Albumin and Total Protein Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of albumin and total protein at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population, Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Grams per liter||Standard Deviation|Mean
690028|NCT01453023|Primary|Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), and Gamma Glutamyl Transferase (GGT) Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of ALT, ALP, AST, and GGT at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||International units per liter (IU/L)||Standard Deviation|Mean
690029|NCT01453023|Primary|Mean Corpuscle Hemoglobin (MCH) Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of MCH at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed.||10^12 picograms (pg) per cell||Standard Deviation|Mean
690030|NCT01453023|Primary|Mean Corpuscle Volume (MCV) Value at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of MCV at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed.||10^15 femtoliters (fL) per cell||Standard Deviation|Mean
690031|NCT01453023|Primary|Hematocrit Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of hematocrit at Day 14 of the respective treatment period. Hematocrit is a measure of the percentage of the volume of the whole blood that is composed of red blood cells, as determined by separation of red blood cells from the plasma (usually by centrifugation).|Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed.||proportion of 1||Standard Deviation|Mean
690032|NCT01453023|Primary|Reticulocyte and Red Blood Cell (RBC) Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of reticulocytes and RBCs at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||10^12 cells per liter (TI/L)||Standard Deviation|Mean
690033|NCT01453023|Primary|Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of hemoglobin and MCHC at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Grams per liter (g/L)||Standard Deviation|Mean
695703|NCT01386632|Secondary|Relative Toxicities for Locally Advanced Head and Neck Squamous Cell Carcinoma Patients Receiving Concurrent Cisplatin, Radiation Therapy, and DCA.||2 years||||||
690034|NCT01453023|Primary|Basophil, Eosinophil, Lymphocyte, Monocyte, Total Neutrophil, Platelet, and White Blood Cell Count Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelets, and white blood cell (WBC) count at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||10^9 cells per liter (GI/L)||Standard Deviation|Mean
690035|NCT01453023|Primary|Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in deciding whether reporting is appropriate in other situations. Refer to the General Adverse AE/SAE module for a complete list of AEs and SAEs.|From the start of study medication until Week 11 (Visit 9)/Early Withdrawal|All Subjects Population: all participants who received at least one dose of study medication||Participants|||Number
690036|NCT01452854|Primary|Ovarian Aging (AFC and Hormones)|Transvaginal Ultrasound will be use to measure Antral Follicle Counts (AFC) and blood will be drawn to measure hormones (FSH, LH, estradiol, estrone, AMH, SHBG, testosterone, and inhibin B).|Every 3 months for 1 year|Data collection was terminated and analyses were not performed due to low enrollment|||||
690042|NCT01452425|Primary|Intracompartmental Pressure (ICP)|[mean (SD)] ICP (in mmHg), value at baseline and at the time of the block|45 minutes|||mmHg||Standard Deviation|Mean
690043|NCT01452425|Primary|Comparison Between INVOS Monitoring and Electromyography|"A comparison will be made between the INVOS monitoring and non invasive (transcutaneous) EMG monitoring (AP Block), to determine the accuracy of the INVOS monitoring to predict AP block.
Measures were:
[mean (SD)] INVOS (in %) value at baseline and at the time of the block"|45 minutes|||% of StcO2||Standard Deviation|Mean
690044|NCT01452347|Secondary|Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at End of Trial (EoT) Week 12|Percentage of patients with observed Ctrough,ss value < 50 ng/mL (As the trial was stopped prematurely, EOT may not be 12 weeks after randomisation for most of the patients) This outcome measure was only analysed for all patients together and not by dose group.|Week 12|Pharmacokinetic set (PKS):Patients were included in the PKS if they were treated with DE, had at least 1 evaluable C trough,ss value and had a non-missing value for gender, age and Creatinine clearance(CrCl) level. Patients who had any important Protocol Violations that may have affected PK data were excluded from the PKS.||percentage of participants|||Number
690045|NCT01452347|Secondary|Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at Week 4|Percentage of patients with observed Ctrough,ss value < 50 ng/mL are presented. This outcome measure was only analysed for all patients together and not by dose group.|Week 4|Pharmacokinetic set (PKS):Patients were included in the PKS if they were treated with DE, had at least 1 evaluable C trough,ss value and had a non-missing value for gender, age and Creatinine clearance(CrCl) level. Patients who had any important Protocol Violations that may have affected PK data were excluded from the PKS.||percentage of participants|||Number
690046|NCT01452347|Secondary|Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at Week 2|Percentage of patients with observed Ctrough,ss value < 50 ng/mL are presented. This outcome measure was only analysed for all patients together and not by dose group.|Week 2|Pharmacokinetic set (PKS):Patients were included in the PKS if they were treated with DE, had at least 1 evaluable C trough,ss value and had a non-missing value for gender, age and Creatinine clearance(CrCl) level. Patients who had any important Protocol Violations that may have affected PK data were excluded from the PKS.||percentage of participants|||Number
690082|NCT01451645|Secondary|Percentage of Participants With at Least 2 Gout Flares From Day 1 to Week 16||Day 1 to Week 16|Efficacy endpoints were analyzed using the FAS. The full analysis set (FAS) included all randomized patients who received any study drug; it is based on the treatment allocated (as randomized).||Percentage of Participants||95% Confidence Interval|Number
695704|NCT01386632|Secondary|HPV Status- Correlate These Findings With Toxicity and Outcome (Exploratory Analysis).||3 months||||||
690047|NCT01452347|Secondary|Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at Week 1|Percentage of patients with observed Ctrough,ss value < 50 ng/mL are presented. This outcome measure was only analysed for all patients together and not by dose group.|Week 1|Pharmacokinetic set (PKS):Patients were included in the PKS if they were treated with DE, had at least 1 evaluable C trough,ss value and had a non-missing value for gender, age and Creatinine clearance(CrCl) level. Patients who had any important Protocol Violations that may have affected PK data were excluded from the PKS.||percentage of participants|||Number
690048|NCT01452347|Primary|Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at End of Trial (EoT) at Week 12|"Comparisons between dabigatran trough plasma levels as predicted by simulations to those observed in the study are performed to validate the dosing algorithm for Dabigatran Etexilate (DE).
(As the trial was stopped prematurely, EOT may not be 12 weeks after randomisation for most of the patients)
Despite the primary endpoint only being assessed in patients who received dabigatran etexilate, Warfarin was included as a comparator treatment in this study in order to facilitate informal comparisons of outcome events, and to look for efficacy signals in this previously unexplored population."|Week 12|Pharmacokinetic set (PKS):Patients were included in the PKS if they were treated with DE, had at least 1 evaluable C trough,ss value and had a non-missing value for gender, age and Creatinine clearance(CrCl) level. Patients who had any important Protocol Violations that may have affected PK data were excluded from the PKS.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
690049|NCT01452347|Primary|Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at Week 4|"Comparisons between dabigatran trough plasma levels as predicted by simulations to those observed in the study are performed to validate the dosing algorithm for Dabigatran Etexilate (DE).
Despite the primary endpoint only being assessed in patients who received dabigatran etexilate, Warfarin was included as a comparator treatment in this study in order to facilitate informal comparisons of outcome events, and to look for efficacy signals in this previously unexplored population."|Week 4|Pharmacokinetic set (PKS):Patients were included in the PKS if they were treated with DE, had at least 1 evaluable C trough,ss value and had a non-missing value for gender, age and Creatinine clearance(CrCl) level. Patients who had any important Protocol Violations that may have affected PK data were excluded from the PKS.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
690050|NCT01452347|Primary|Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at Week 2|"Comparisons between dabigatran trough plasma levels as predicted by simulations to those observed in the study are performed to validate the dosing algorithm for Dabigatran Etexilate (DE).
Despite the primary endpoint only being assessed in patients who received dabigatran etexilate, Warfarin was included as a comparator treatment in this study in order to facilitate informal comparisons of outcome events, and to look for efficacy signals in this previously unexplored population."|Week 2|Pharmacokinetic set (PKS):Patients were included in the PKS if they were treated with DE, had at least 1 evaluable C trough,ss value and had a non-missing value for gender, age and Creatinine clearance(CrCl) level. Patients who had any important Protocol Violations that may have affected PK data were excluded from the PKS.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
690051|NCT01452347|Primary|Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations at Steady State (C Trough,ss) at Week 1|"Comparisons between dabigatran trough plasma levels as predicted by simulations to those observed in the study are performed to validate the dosing algorithm for Dabigatran Etexilate (DE) .
Despite the primary endpoint only being assessed in patients who received dabigatran etexilate, Warfarin was included as a comparator treatment in this study in order to facilitate informal comparisons of outcome events, and to look for efficacy signals in this previously unexplored population."|Week 1|Pharmacokinetic set (PKS):Patients were included in the PKS if they were treated with DE, had at least 1 evaluable C trough,ss value and had a non-missing value for gender, age and Creatinine clearance(CrCl) level. Patients who had any important Protocol Violations that may have affected PK data were excluded from the PKS.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
690052|NCT01452269|Primary|Change in Physical Activity Assessment (PAA) Score|We measured the mean change in the moderate PAA scoare for the immediate and delayed groups, from baseline to 6 months (post-intervention for the immediate group; no intervention yet for the delayed group). We used intention to treat analyses, with any missing values carried forward from baseline to the 6-month data point. PAA moderate activity scores range from 0-27; higher scores are better (more physical activity).|Baseline and 6 months|||moderate PAA score||Standard Error|Mean
690053|NCT01452269|Primary|Change in Dietary Risk Assessment (DRA) Score|We measured the mean change in DRA score for the immediate and delayed groups, from baseline to 6 months (post-intervention for the immediate group; no intervention yet for the delayed group). We used intention to treat analyses, with any missing values carried forward from baseline to the 6-month data point. DRA scores range from 0-96; lower scores are better (improved dietary quality).|Baseline and 6 months|||DRA score||Standard Error|Mean
690054|NCT01452269|Primary|Weight Change|We measured the mean change in weight for the immediate and delayed groups, from baseline to 6 months (post-intervention for the immediate group; no intervention yet for the delayed group). We used intention to treat analyses, with any missing values carried forward from baseline to the 6-month data point.|Baseline and 6 months|||kilograms||Standard Error|Mean
690055|NCT01452152|Secondary|Composite of All-cause Death, Myocardial Infarction (MI), Stroke and Repeat Revascularization||One year||||||
690056|NCT01452152|Secondary|Occurrence of Adverse Events||One year||||||
690057|NCT01452152|Secondary|Health Care Resource Utilization and Cost-effectiveness||One year||||||
690058|NCT01452152|Secondary|Post-treatment Platelet Aggregation|Platelet aggregation will be performed on a subset of subjects. Platelet aggregation studies are optional and will not be used to modulate antiplatelet therapy|10 days||||||
690059|NCT01452152|Secondary|Occurrence of Bleeding Events|Bleeding events will classified by the Bleeding Academic Research Consortium definition.|One year||||||
690060|NCT01452152|Primary|Occurrence of Post-randomization Cardiovascular Events|Cardiovascular events include non-fatal myocardial infarction, non-fatal stroke, definite or probable stent thrombosis (ARC definition) and death secondary to any cardiovascular cause.|One year|||participants|||Number
690061|NCT01452126|Secondary|Number of Patients With Complications|All patients were followed up for complications such as bleeding, infection, side effects, nerve damage|3 days|||Participants|||Count of Participants
690072|NCT01451775|Secondary|Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Clinical Laboratory Tests and Assessment of Tolerability by the Investigator.|Clinically relevant abnormalities for physical examination, vital signs, ECG, blood chemistry, haematology, urinanalysis and assessment of tolerability by the investigator. New abnormal findings or worsening of baseline conditions were reported as adverse events (AEs). Time frame for AE reporting includes the period of first drug administration until end of study. A more detailed definition of the used time frame and MedDRA Version can be found in the AE section.|Screening until end of trial, average of 45 days|Treated Set(TS): TS includes all subjects who have taken at least 1 dose of trial medication||participants|||Number
690073|NCT01451775|Primary|Maximum Measured Concentration (Cmax)|"Maximum measured concentration of empagloflozin (empa) in plasma, per period.
The Measured Values show intra-arm variabilities, whereas the statistical analyses show inter-arm variabilities."|1 hour (h) before study drug and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|All treated subjects who provided at least one observation in the relevant treatment periods for at least one primary pharmacokinetic (PK) endpoint without a relevant protocol deviation and who had not experienced emesis before or at 2 times median tmax in at least one of the two relevant treatment periods.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
690074|NCT01451775|Primary|Area Under the Curve 0 to Infinity (AUC0-∞)|"Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 hours extrapolated to infinity (AUC0-∞).
The Measured Values show intra-arm variabilities, whereas the statistical analyses show inter-arm variabilities."|1 hour (h) before study drug and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|All treated subjects who provided at least one observation in the relevant treatment periods for at least one primary pharmacokinetic (PK) endpoint without a relevant protocol deviation and who had not experienced emesis before or at 2 times median tmax in at least one of the two relevant treatment periods.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
690075|NCT01451762|Primary|Quality of Recovery 40 at 24 Hours|Scores on QOR (quality of recovery) 40 questionnaire.The QoR-40 score, which ranges from 40 to 200, representing very poor to outstanding quality of recovery, respectively.|24 hours post operatively|Primary outcome was QOR 40 a sample size of 23 per group was estimated to achieve 80% power to detect a 10 point difference in aggregated QOR040 score for the three groups. A 10 point difference represents a clinically relevant improvement in quality of recovery. TO account for drop outs lost to follow up 90 subjects were randomized.||units on scale 40 (low) - 200 (high)||Inter-Quartile Range|Median
690076|NCT01451749|Secondary|Change in Functional Scores: Instrumental Activities of Daily Living (IADL).|Functional ability was evaluated with the Instrumental Activities of Daily Living (IADL) IADL, at baseline (day 1 clinic visit), at the mid-study (week 12), and at the endpoint of treatment (week 24). The IADL contains eight items, which are the ability to use a telephone, shop, prepare food, run laundry, use modes of transportation, take responsibility for one’s own medications, complete housekeeping, and handle finances,each items ranges from 1 to 4 points, 1 points means no problem, and 4 points means greater impairment in instumental acvtiveity of daily living.The total is sub of the eight items, and the total range of the IADL is 8-32 points, higher scores indicate greater impairments. The changes was calculted by weeks 24 minus baseline.|Baseline to weeks 24|The efficacy measurement were conducted in the intent-to-treat population, the ITT consist all randomized population who take at least one dose of medication and at least one primary efficacy evaluation on treatment.||units on a scale||95% Confidence Interval|Mean
690077|NCT01451749|Secondary|Change in Memory Scores: The Delayed Story Recall (DSR) Test From the Adult Memory and Information Processing Battery (AMIPB)|memory function was evaluated with the DSR subtest,at baseline (day 1 clinic visit), at the mid-study (week 12), and at the endpoint of treatment (week 24). The DSR is a tool which was designed to assess immediate registration of verbal information and retention over time. It contains six sub-tests: two verbal memory tests (one of which is a story recall), two visual memory tests and two information-processing tests. The story recall test includes immediate story recall (ISR) and delayed story recall (DSR). The DSR total score ranges from 0-56 points. Lowers score means higher impairment of memory.The Change in cognitive scores was calculated as 24 week minus the baseline.|Baseline and 24 weeks|The efficacy measurement was conducted of ITT patients. The intent-to-treat population (ITT) consist all randomized population who take at least one dose of medication and at least one primary efficacy evaluation on treatment.||units on a scale||95% Confidence Interval|Mean
690078|NCT01451749|Primary|Change in Cognitive Scores: Alzheimer Disease Assessment Scale-cognitive. Subscale (ADAS-cog)|Cognition was assessed with the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) , at baseline (day 1 clinic visit) and at 12-week intervals thereafter until week 24. The ADAS-cog was designed specifically to evaluate the severity of cognitive dysfunctions characteristic of AD patients and includes 11 items. Among these items, memory, orientation, language function, practical ability, and attention are evaluated. The score on the ADAS-cog range from 0 to 70 point, with 0 point indicating no impairment and 70 points indicating severe impairment of cognition. In the Shenwu capsule group, the ADAS-cog score is ranges 3-38.3 points, and 3.3-30.7 points in the Donepezil group. The Change in cognitive scores was calculated as24 week minus the baseline.|baseline and 24 weeks|the analyses for efficacy were conducted in the intent-to-treat population (ITT). The intent-to-treat population (ITT) consist all randomized population who take at least one dose of medication and at least one primary efficacy evaluation on treatment.||units on a scale||95% Confidence Interval|Mean
690079|NCT01451723|Secondary|Brain Atrophy|Difference between the two groups in brain atrophy as measured by SIENA|1 year||||||
690080|NCT01451723|Primary|Rate of Change in NAA Levels Adjusted for Water Content.|The rate of change will be calculated using all the time points available )baseline, 6 and 12 months) using a mixed model analysis with the Log NAA as the dependent variable and water content, %grey matter, %white matter, %CSF and % lesion volume as covariates. All the voxels available for each subject where estimates have a SD <30 will be used. A spatial anysotropic exponential covariance structure will be used.|1 year|No subjects completed either the six or twelve month point so no data was available for analysis.|||||
690081|NCT01451645|Secondary|Mean Number of Gout Flare Days Per Participant Assessed From Day 1 to Week 16||Day 1 to Week 16|Efficacy endpoints were analyzed using the FAS. The full analysis set (FAS) included all randomized patients who received any study drug; it is based on the treatment allocated (as randomized).||days||Standard Deviation|Mean
690083|NCT01451645|Secondary|Percentage of Participants With at Least 1 Gout Flare From Day 1 to Week 16||Day 1 to Week 16|Efficacy endpoints were analyzed using the FAS. The full analysis set (FAS) included all randomized patients who received any study drug; it is based on the treatment allocated (as randomized).||Percentage of Participants||95% Confidence Interval|Number
690084|NCT01451645|Primary|Number of Gout Flares Per Participant From Day 1 to Week 16||Day 1 to Week 16|Efficacy endpoints were analyzed using the FAS. The full analysis set (FAS) included all randomized patients who received any study drug; it is based on the treatment allocated (as randomized).||gout flares||Standard Deviation|Mean
690085|NCT01451632|Secondary|Immunogenicity|Samples were collected to determine the presence of an immunologic reaction to MM-121 (i.e. human anti-human antibodies).|Samples were collected for all patients pre-dose on all cycles for duration of treatment, the longest of which was 48.1 weeks, and a collection was made post-infusion in any case of infusion reaction||||||Number
690086|NCT01451632|Secondary|Pharmacokinetic Parameters of MM-121|Pharmacokinetic (PK) evaluation was performed on plasma samples obtained weekly for the first six weeks of the study and then on day 1 of each additional cycle to assess pre-treatment trough concentrations of MM-121. Non-compartmental analysis (NCA) was performed to calculate standard PK parameters, including the AUClast. Serum levels of MM-121 were measured at a central lab using an enzyme-linked immunosorbent assay (ELISA). Data is presented per dose level of MM-121 (12 mg/kg, 20 mg/kg, or 40/20 mg/kg) and per study part (Part 1 or Part 2)|Collections taken for all patients at Cycle 1, Week 1 at pre-infusion, at the end of the infusion, and 2.5, 4, 6 and 24 hours after starting the infusion of MM-121|Data presented by dose level of MM-121, regardless of the cohort (i.e. 15 patients in Part 1 were administered the 40/20 dose level of MM-121: 3 in cohort 3b, 4 in cohort 4, and 8 in the Part 1 expansion)||hr* ug/mL||Geometric Coefficient of Variation|Geometric Mean
690087|NCT01451632|Secondary|Pharmacokinetics|Pharmacokinetic (PK) evaluation was performed on plasma samples obtained weekly for the first six weeks of the study and then on day 1 of each additional cycle to assess pre-treatment trough concentrations of MM-121. Non-compartmental analysis (NCA) was performed to calculate standard PK parameters, including the maximum observed concentration (Cmax). Serum levels of MM-121 were measured at a central lab using an enzyme-linked immunosorbent assay (ELISA). Data is presented per dose level of MM-121 (12 mg/kg, 20 mg/kg, or 40/20 mg/kg) and per study part (Part 1 or Part 2)|Collections taken for all patients at Cycle 1, Week 1 at pre-infusion, at the end of the infusion, and 2.5, 4, 6 and 24 hours after starting the infusion of MM-121|||ug/mL||Geometric Coefficient of Variation|Geometric Mean
690088|NCT01451632|Secondary|Objective Response Rate|To determine the number of patients reporting an objective response using RECIST v 1.1 where a Partial Response (PR) is defined as >20% decrease in tumor burden from baseline and a Complete Response (CR) is defined as complete disappearance from tumor burden from baseline. Objective Response is presented as the total # patients with PR or CR.|Patients were assessed for objective response from time of first dose through treatment termination, the longest treatment duration being 48.1 weeks|||participants with objective response|||Number
690089|NCT01451632|Primary|To Further Determine the Safety Parameters of the MM-121 + Cetuximab and MM-121 + Cetuximab + Irinotecan Combination by Determining the Recommended Phase 2 Dose (RP2D) of the Combination(s): Cetuximab and Irinotecan|"Using a 3+3 dose escalation model, the maximum tolerated dose of each combination was determined by assessing dose-limiting toxicities in each cohort. RP2D = one dose lever lower than the MTD
Part 1:
Cohort 1: MM-121: 12 mg/kg MM-121 QW + Cetuximab: 400 mg/m2 loading dose/200 mg/m2 (400/200) QW maintenance Cohort 2a: MM-121: 20 mg/kg IV QW + Cetuximab: 400 / 200 mg/m2 maintenance IV QW Cohort 2b: MM-121: 12 mg/kg IV QW + Cetuximab: 400 /250 mg/m2 maintenance IV QW Cohort 3a: MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW (40/20) + Cetuximab: 400 / 200 mg/m2 maintenance IV QW Cohort 3b: MM-121 20 mg/kg IV QW + Cetuximab: 400 /250 mg/m2 maintenance IV QW Cohort 4: MM-121: 40/20 mg/kg IV QW + Cetuximab: 400 / 250 mg/m2 maintenance IV QW
Part 2:
Cohort 1: MM-121: 20 mg/kg IV QW + Cetuximab: 400/200 mg/m2 maintenance IV QW + Irinotecan: 180 mg/m2 IV Q2W Cohort 2: MM-121: 40 / 20 mg/kg IV QW + Cetuximab: 400/250 mg/m2 maintenance IV QW + Irinotecan: 180 mg/m2"|From date of first dose to 30 days after termination, the longest 48.1 weeks|Number of patients participating in dose-escalation portion (excluding expansion cohort patients who were not evaluated for DLTs and thus not included in determining MTD/RP2D) NOTE: MTD of MM-121 provided in separate endpoint entry||mg/m2|||Number
690090|NCT01451632|Primary|To Further Determine the Safety Parameters of the MM-121 + Cetuximab and MM-121 + Cetuximab + Irinotecan Combination by Determining the Recommended Phase 2 Dose (RP2D) of the Combination(s) (Via Recording of Maximum Tolerated Dose (MTD)): MM-121 Doses|"Using a 3+3 dose escalation model, the maximum tolerated dose of each combination was determined by assessing dose-limiting toxicities in each cohort. RP2D = one dose lever lower than the MTD
Part 1:
Cohort 1: MM-121: 12 mg/kg MM-121 QW + Cetuximab: 400 mg/m2 loading dose/200 mg/m2 (400/200) QW maintenance Cohort 2a: MM-121: 20 mg/kg IV QW + Cetuximab: 400 / 200 mg/m2 maintenance IV QW Cohort 2b: MM-121: 12 mg/kg IV QW + Cetuximab: 400 /250 mg/m2 maintenance IV QW Cohort 3a: MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW (40/20) + Cetuximab: 400 / 200 mg/m2 maintenance IV QW Cohort 3b: MM-121 20 mg/kg IV QW + Cetuximab: 400 /250 mg/m2 maintenance IV QW Cohort 4: MM-121: 40/20 mg/kg IV QW + Cetuximab: 400 / 250 mg/m2 maintenance IV QW
Part 2:
Cohort 1: MM-121: 20 mg/kg IV QW + Cetuximab: 400/200 mg/m2 maintenance IV QW + Irinotecan: 180 mg/m2 IV Q2W Cohort 2: MM-121: 40 / 20 mg/kg IV QW + Cetuximab: 400/250 mg/m2 maintenance IV QW + Irinotecan: 180 mg/m2"|From date of first dose to 30 days after termination, the longest 48.1 weeks|Number of patients participating in dose-escalation portion (excluding expansion cohort patients who were not evaluated for DLTs) MTD of cetuximab and irinotecan for the combination(s) are presented in a separate endpoint entry||mg/kg|||Number
690091|NCT01451632|Primary|Dose Escalation: To Evaluate the Safety and Tolerability of Escalating Doses of the MM-121 Plus Cetuximab and the MM-121 Plus Cetuximab Plus Irinotecan Combination|To establish the safety of escalating doses of MM-121 in combination with cetuximab or in combination with cetuximab and irinotecan in order to determine the recommended phase 2 dose.. Dose-escalation conducted using standard 3+3 model to determine maximum tolerated dose. Reports of Dose-Limiting Toxicities (DLTs) were assessed to determine the MTD.|From date of first dose to 30 days after termination, the longest 48.1 weeks|Patients participating in dose escalation||participants reporting DLTs|||Number
690092|NCT01451554|Primary|Weight Change at 6 Months|Weight change as a percentage of baseline at post 6 months.|6 months|Intent to treat population includes all randomzied subjects. Missing data were imputed using the last observation carried forward.||percentage||Standard Deviation|Mean
690098|NCT01451541|Secondary|Time to Maximal Effect [Time to >= 90% Maximum Difference From Placebo in LS Means (Days)]|The time to maximal effect is defined as the number of days until the first treatment day on which the estimated difference between active ciclesonide nasal aerosol and placebo is at least 90% of the largest estimated difference.This is based on the analyses of change from baseline in the average of AM and PM reflective TNSS scores for each day. The time to achieve at least 90% of these estimated differences was calculated.|Weeks 0 -6|The Intent to Treat (ITT) population: All randomized subjects who received at least one dose of double blind study medication.||Number of Days|||Number
690099|NCT01451541|Secondary|Change From Baseline in Daily PRQLQ Overall Score at the End of the 12-week Double-blind Treatment Period|PRQLQ was developed to measure the functional problems (physical, emotional, and social) that are most troublesome to children with rhinoconjunctivitis. The PRQLQ has 23 questions in 5 domains (nose symptoms, eye symptoms, practical problems, activity limitation, and other symptoms). Children recalled how they were during the previous week and responded to each question on a 7-point scale (0 = not bothered to 6 = extremely bothered or 0 = none of the time to 6 = all of the time) for a total possible score of 138. The overall PRQLQ score is the mean of all 23 responses.|Weeks 0 -12|The Intent to Treat (ITT) population: All randomized subjects who received at least one dose of double blind study medication.||units on a scale||Standard Error|Least Squares Mean
690100|NCT01451541|Secondary|Change From Baseline in Daily Average Subject-reported AM iTNSS Averaged Over the First 6 Weeks of Double-blind Treatment|TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1 = mild 2 = moderate 3 = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.|Weeks 0 -6|The Intent to Treat (ITT) population: All randomized subjects who received at least one dose of double blind study medication.Subjects with either missing baseline data or postdose data, or both and were not included in the analysis.||units on a scale||Standard Error|Least Squares Mean
690101|NCT01451541|Secondary|Change From Baseline in Daily Average Subject-reported AM and PM iTNSS Averaged Weekly Over the 12-week Double-blind Treatment Period|TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1 = mild 2 = moderate 3 = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the twelve week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.|Weeks 0 -12|The Intent to Treat (ITT) population: All randomized subjects who received at least one dose of double blind study medication.||units on a scale||Standard Error|Least Squares Mean
690102|NCT01451541|Secondary|Change From Baseline in Daily Average Subject-reported AM and PM rTNSS Averaged Weekly Over the 12-week Double-blind Treatment Period|TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1 = mild 2 = moderate 3 = severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the twelve week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement|Weeks 0 -12|The Intent to Treat (ITT) population: All randomized subjects who received at least one dose of double blind study medication.Subjects with either missing baseline data or postdose data, or both and were not included in the analysis.||units on a scale||Standard Error|Least Squares Mean
690103|NCT01451541|Secondary|Change From Baseline in the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Overall Score at the End of the First 6 Weeks of Double-blind Treatment|PRQLQ was developed to measure the functional problems (physical, emotional, and social) that are most troublesome to children with rhinoconjunctivitis. The PRQLQ has 23 questions in 5 domains (nose symptoms, eye symptoms, practical problems, activity limitation, and other symptoms). Children recalled how they were during the previous week and responded to each question on a 7-point scale (0 = not bothered to 6 = extremely bothered or 0 = none of the time to 6 = all of the time) for a total possible score of 138. The overall PRQLQ score is the mean of all 23 responses.|Weeks 0 -6|The Intent to Treat (ITT) population: All randomized subjects who received at least one dose of double blind study medication.Subjects with either missing baseline data or postdose data, or both and were not included in the analysis.||units on a scale||Standard Error|Least Squares Mean
690104|NCT01451541|Secondary|Change From Baseline in Average Daily Subject-reported AM and PM Instantaneous Total Nasal Symptom Scores (iTNSS) Averaged Weekly Over the First 6 Weeks of Double-blind Treatment|TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1 = mild 2 = moderate 3 = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.|Weeks 0 -6|The Intent to Treat (ITT) population: All randomized subjects who received at least one dose of double blind study medication.Subjects with either missing baseline data or postdose data, or both and were not included in the analysis.||units on a scale||Standard Error|Least Squares Mean
690114|NCT01451437|Secondary|Number of Participants With CRi at Dose Levels Other Than RP2D|Clinical activity of MK-8242 given as monotherapy in participants with refractory or recurrent AML measured as participants who achieved CRi according to Cheson (2003) criteria at dose levels other than RP2D. CRi is defined as fulfillment of all CR criteria with exceptions for residual neutropenia (<1,000/µL), thrombocytopenia (<100,000/µL), and RBC transfusion dependence. Presented outcome values are not stratified for dose levels other than RP2D; the RP2D for MK-8242 monotherapy could not be established due to early termination of the study.|End of Treatment (up to 198 days)|Modified Full Analysis Set for Efficacy: all participants with confirmed p53 WT status who received at least one dose of MK-8242.||Participants|||Number
695705|NCT01386632|Secondary|Immune Response and Correlate These Findings With Toxicity and Outcome (Exploratory Analysis).||3 months||||||
690105|NCT01451541|Primary|The Change From Baseline in Average Daily Subject-reported AM and PM Reflective Total Nasal Symptom Scores (rTNSS) Averaged Weekly Over the First 6 Weeks of the Double-blind Treatment.|TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1 = mild 2 = moderate 3 = severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.|Weeks 0-6|The Intent to Treat (ITT) population: All randomized subjects who received at least one dose of double blind study medication.Subjects with either missing baseline data or postdose data, or both and were not included in the analysis.||units on a scale||Standard Error|Least Squares Mean
690106|NCT01451437|Secondary|Urine Concentration of MK-8242 (Part 2 Arm A Only)|The urine concentration of MK-8242 assessed as a measure of drug bioavailability was not determined due to early termination of the study (Study Part 2 was not performed).|Day 1 (predose and postdose) and Day 7 (postdose)|Participants who received at least one dose of MK-8242, were compliant with study procedures, and had available pharmacokinetic data (urine concentration) at the time of assessment|||||
690107|NCT01451437|Secondary|Accumulation Ratio (R) of MK-8242 Alone and in Combination With Cytarabine|The accumulation ratio (R) at steady state (based on dosing interval and apparent terminal half-life (t1/2)) for MK-8242 alone was not determined due to confounding of results by significant concentrations of a drug metabolite (M16). Analysis for the combination therapy was not performed due to early termination of the study (Study Arm B was not performed).|Cycle 1 Day 7 (QD arms: predose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 24, and 48 hrs postdose; BID arms: predose and 0.5, 1, 2, 4, 6, 8, 12 [optional], 24 [Day 7 only], 48 [Day 7 only] hrs postdose)|Participants who received at least one dose of MK-8242, were compliant with study procedures, and had available pharmacokinetic data (R) at the time of assessment.|||||
690108|NCT01451437|Secondary|Apparent Terminal Half-life (t1/2) for MK-8242 Alone and in Combination With Cytarabine|Elimination phase t1/2 was determined for Cycle 1 Day 7 of MK-8242 QD and BID dosing. Analysis for the combination therapy was not performed due to early termination of the study (Study Arm B was not performed).|Cycle 1 Day 7 (QD arms: predose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 24, and 48 hrs postdose; BID arms: predose and 0.5, 1, 2, 4, 6, 8, 12 [optional], 24, 48 hrs postdose)|Participants who received at least one dose of MK-8242, were compliant with study procedures, and had available pharmacokinetic data (at least three time-points after Tmax).||hr||Geometric Coefficient of Variation|Geometric Mean
690109|NCT01451437|Secondary|Time to Maximum Concentration (Tmax) of MK-8242 Alone and in Combination With Cytarabine|Tmax was determined for Cycle 1 Days 1 and 7 of MK-8226 QD and BID dosing. Analysis for the combination therapy was not performed due to early termination of the study (Study Arm B was not performed).|Cycle 1, Day 1 and Day 7 (QD arms: predose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 24, and 48 [Day 7 only] hrs postdose; BID arms: predose and 0.5, 1, 2, 4, 6, 8, 12 [optional], 24 [Day 7 only], 48 [Day 7 only] hrs postdose)|Participants who received at least one dose of MK-8242, were compliant with study procedures, and had available pharmacokinetic data (Tmax) at the time of assessment.||Hours||Full Range|Median
690110|NCT01451437|Secondary|Maximum Plasma Concentration (Cmax) of MK-8242 Alone and in Combination With Cytarabine|Cmax was determined for Cycle 1 Days 1 and 7 of MK-8226 QD and BID dosing. Analysis for the combination therapy was not performed due to early termination of the study (Study Arm B was not performed).|Cycle 1, Day 1 and Day 7 (QD arms: predose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 24, and 48 [Day 7 only] hrs postdose; BID arms: predose and 0.5, 1, 2, 4, 6, 8, 12 [optional], 24 [Day 7 only], 48 [Day 7 only] hrs postdose)|Participants who received at least one dose of MK-8242, were compliant with study procedures, and had available pharmacokinetic data (Cmax) at the time of assessment.||nM||Geometric Coefficient of Variation|Geometric Mean
690111|NCT01451437|Secondary|Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞) for MK-8242 Alone and in Combination With Cytarabine|AUC0-∞ defined as AUC from time zero to infinity was determined for Cycle 1 Day 7 of MK-8242 QD and BID dosing using the trapezoidal up/log trapezoidal down method. Projection beyond the last sampled time was made if a linear terminal elimination phase half-life was identified with three time-points after Tmax (condition not met for 60 QD and 120 BID dose groups). Analysis for the combination therapy was not performed due to early termination of the study (Study Arm B was not performed).|Cycle 1 Day 7 (QD arms: predose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 24, and 48 hrs postdose; BID arms: predose and 0.5, 1, 2, 4, 6, 8, 12 [optional], 24, 48 hrs postdose)|Participants who received at least one dose of MK-8242, were compliant with study procedures, and had available pharmacokinetic data (AUC0-∞) at the time of assessment.||hr*nM||Geometric Coefficient of Variation|Geometric Mean
690112|NCT01451437|Secondary|Area Under the Concentration-time Curve From Time 0 to Last (AUC0-last) for MK-8242 Alone and in Combination With Cytarabine|AUC(0-last) defined as AUC from time zero to the time of last quantifiable sample was determined for Cycle 1 Days 1 and 7 of MK-8242 QD and BID dosing using the trapezoidal up/log trapezoidal down method. Analysis for the combination therapy was not performed due to early termination of the study (Study Arm B was not performed).|Cycle 1, Day 1 and Day 7 (QD arms: predose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 24, and 48 [Day 7 only] hrs postdose; BID arms: predose and 0.5, 1, 2, 4, 6, 8, 12 [optional], 24 [Day 7 only], 48 [Day 7 only] hrs postdose)|Participants who received at least one dose of MK-8242, were compliant with study procedures, and had available pharmacokinetic data (AUC0-last) at the time of assessment.||hr*nM||Geometric Coefficient of Variation|Geometric Mean
690113|NCT01451437|Secondary|Area Under the Concentration-time Curve From Time 0 to 24 Hours (AUC0-24hr) for MK-8242 Alone and in Combination With Cytarabine|AUC(0-24hr) defined as AUC from time zero to 24 hours was determined for Cycle 1 Days 1 and 7 of MK-8242 QD and BID dosing using the trapezoidal up/log trapezoidal down method. For the BID arms, a projection beyond the last sampled time was made if a linear terminal elimination phase half-life was identified with three time-points after Tmax. Analysis for the combination therapy was not performed due to early termination of the study (Study Arm B was not performed).|Cycle 1, Day 1 and Day 7 (QD arms: predose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, and 24 hrs postdose; BID arms: predose and 0.5, 1, 2, 4, 6, 8, 12 [optional], and 24 [Day 7 only] hrs postdose)|Participants who received at least one dose of MK-8242, were compliant with study procedures, and had available pharmacokinetic data (AUC0-24hr) at the time of assessment.||hr*nM||Geometric Coefficient of Variation|Geometric Mean
690115|NCT01451437|Secondary|Number of Participants With CR at Dose Levels Other Than RP2D|Clinical activity of MK-8242 given as monotherapy in participants with refractory or recurrent AML measured as participants who achieved CR according to Cheson (2003) criteria at dose levels other than RP2D. CR is defined as a morphologic leukemia-free state with a neutrophil count ≥1,000/µL, a platelet count ≥100,000/µL, no extramedullary disease, and RBC transfusion independence. Presented outcome values are not stratified for dose levels other than RP2D; the RP2D for MK-8242 monotherapy could not be established due to early termination of the study.|End of Treatment (up to 198 days)|Modified Full Analysis Set for Efficacy: all participants with confirmed p53 WT status who received at least one dose of MK-8242.||Participants|||Number
690116|NCT01451437|Primary|Number of Participants With Complete Remission With Incomplete Marrow Recovery (CRi) at RP2D|Clinical activity of MK-8242 given as monotherapy in participants with refractory or recurrent AML measured as participants who achieved CRi according to Cheson (2003) criteria at the RP2D. The outcome analysis was not performed since the RP2D for MK-8242 monotherapy could not be established due to early termination of the study.|End of Treatment (up to 198 days)|Full Analysis Set for Efficacy: all participants with confirmed p53 WT status who received at least one dose of MK-8242 and have at least one baseline and one post-baseline efficacy assessment.|||||
690117|NCT01451437|Primary|Number of Participants With Complete Remission (CR) at RP2D|Clinical activity of MK-8242 given as monotherapy in participants with refractory or recurrent AML measured as participants who achieved CR according to Cheson (2003) criteria at the RP2D. The outcome analysis was not performed since the RP2D for MK-8242 monotherapy could not be established due to early termination of the study.|End of Treatment (up to 198 days)|Full Analysis Set for Efficacy: all participants with confirmed p53 wild type (WT) status who received at least one dose of MK-8242 and have at least one baseline and one post-baseline efficacy assessment.|||||
690118|NCT01451437|Primary|Number of Participants With Dose Limiting Toxicities (DLTs)|DLTs were identified using Common Terminology Criteria for Adverse Events (CTCAE) v. 4.0 for toxicities attributable to the study drug. Hematologic DLTs were defined in the absence of morphological evidence of acute leukemia in the marrow if 1) bone marrow: aplastic marrow with <5% cellularity without erythroid, myeloid, or megakaryocytic precursors and 2) peripheral blood: absolute neutrophil count (ANC) <100/µL, platelet count <10,000/µL, and transfusion-dependent anemia. Non-hematologic DLTs were defined as any ≥Grade 3 toxicity with the following exceptions/clarifications: 1) infection, fatigue, anorexia, or alopecia are not included in determination of the DLT 2) Grade 3 nausea, vomiting, diarrhea, or dehydration occurring in a setting of inadequate treatment 3) any abnormal non-hematological laboratory value ≥Grade 3 will be considered a DLT after 72 hours of appropriate medical intervention if not related to an underlying disease or not attributable to another event.|Up to 28 days (Cycle 1) for non-hematologic toxicities and 42 days (Cycle 1) for hematologic toxicities|DLT-evaluable Population: participants who received at least one dose of MK-8242 and completed Cycle 1 of Part 1 or discontinued due to reason of toxicity.||Participants|||Number
690119|NCT01451424|Secondary|Change in Quality of Life|Percentage change from baseline in median quality of life using uterine fibroid symptom and quality of life questionnaire (UFSQOL)|12 or 16 weeks|MITT. Note: lower score is improvement||Percent change||Full Range|Median
690120|NCT01451424|Secondary|Endometrial Thickness|Percent change in median endometrial thickness from baseline to end of treatment assessed by ultrasound determination of uterine stripe.|12 or 16 weeks|Safety population, data based on subjects with both baseline and end of treatment assessments||Percent change||Full Range|Median
690121|NCT01451424|Secondary|Induction of Amenorrhea at End of Treatment|"Percentage of subjects with induced amenorrhea during last 28 days on drug
Amenorrhea was deemed to be achieved if no daily bleeding score was greater than 1 during the last 28 calendar days of the dosing period. A score of 1 was to be indicated if spotting was observed which did not require a sanitary product. Subjects that terminated early were deemed not to have achieved amenorrhea."|End of treatment|||Percentage of particpants|||Number
690122|NCT01451424|Secondary|Uterine Fibroid Size|Percent change in volume of confirmed uterine fibroids at end of treatment, assessed by MRI|12 or 16 weeks|MITT population||Percentage change||Full Range|Median
690123|NCT01451424|Secondary|Blood Levels of Proellex|Determination of Cmax of Proellex at end of treatment|12 or 16 weeks|Subjects with end of treatment PK assessment||ng/dL||Standard Deviation|Mean
690124|NCT01451424|Primary|Change From Baseline in Vaginal Bleeding|"Change from baseline in vaginal bleeding assessed at the end of treatment (12 or 16 weeks) using a Pictorial Blood Loss Assessment Chart (PBAC), which measures volume (mL) of blood loss over a 28-day period
Less blood loss represents an improvement."|12 or 16 weeks|MITT population||mL||Full Range|Median
690125|NCT01451411|Secondary|Population Pharmacokinetics: Volume of Distribution (Vd)|Based on conivaptan concentrations, the pharmacokinetics of the study population will be analyzed to determine median Vd|Up to Hour 60|Due to the terminated status of the study, pharmacokinetic samples were not analyzed.|||||
690126|NCT01451411|Secondary|Population Pharmacokinetics: Clearance (CL)|Based on conivaptan concentrations, the pharmacokinetics of the study population will be analyzed to determine median CL|Up to Hour 60|Due to the terminated status of the study, pharmacokinetic samples were not analyzed.|||||
690127|NCT01451411|Secondary|Number of Participants With an Overly Rapid Rise in Serum Sodium From Baseline|an absolute serum sodium of 145 mEq/L at Hour 24 or an increase in serum sodium of greater than 12 mEq/L|baseline and Hours 3, 8, 12 and 24.|||participants|||Number
690128|NCT01451411|Secondary|Change From Baseline in Free Water Clearance (FWC)||Baseline and 48 hours|The protocol specifies that calculations for this endpoint were to be derived by the statistical team. Due to the terminated status of the study, a statistical team was not employed and calculations to determine this variable were not performed.|||||
690129|NCT01451411|Secondary|Change From Baseline in Effective Water Clearance (EWC) Every 12 Hours||Baseline, Hours 12, 24, 36 and 48|The protocol specifies that calculations for this endpoint were to be derived by the statistical team. Due to the terminated status of the study, a statistical team was not employed and calculations to determine this variable were not performed.|||||
690130|NCT01451411|Secondary|Number of Subjects With Confirmed > 6 mEq/L Increase From Baseline in Serum Sodium or a Confirmed Normal Serum Sodium Level (Greater Than or Equal to 135 mEq/L)||baseline and 48 hours|||participants|||Number
690131|NCT01451411|Secondary|Number of Patients With Confirmed ≥ 4 mEq/L Increase From Baseline in Serum Sodium||baseline and 48 hours|||participants|||Number
690144|NCT01451398|Secondary|FPG Change From Baseline to Week 24|Efficacy as measured by mean change in fasting plasma glucose (FPG)|Baseline to Week 24|Full analysis set for subjects with data at both Baseline and at Week 24||mg/dL||Standard Error|Least Squares Mean
690145|NCT01451398|Secondary|Proportion of Responders Achieving HbA1c <= 6.5%|Efficacy as measured in proportion of subjects achieving HbA1c < or = to 6.5% at Week 24|Week 24|Full analysis set for subjects with available data at Week 24||percentage of participants|||Number
690146|NCT01451398|Secondary|Proportion of Responders Achieving HbA1c <= 7.0%|Efficacy as measured in proportion of subjects achieving HbA1c < or = to 7.0%|Week 24|Full analysis set for subjects with available data at Week 24||percentage of participants|||Number
690147|NCT01451398|Primary|Change From Baseline to Week 24 in HbA1c|Efficacy as measured by change in glycated hemoglobin (HbA1c) at Week 24|Baseline to Week 24|Full analysis set||percentage of hemoglobin||Standard Error|Least Squares Mean
690148|NCT01451203|Secondary|Percentage of Participants Meeting the American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean-based Remission Criteria at Weeks 24 and 52|"The ACR/EULAR Boolean-based remission rate measures the severity of disease at a specific time and is derived from the following variables:
28 tender joint count (TJC);
28 swollen joint count (SJC);
Patient's global assessment of disease activity (PtGADA);
C-reactive protein (CRP)
To obtain the tender joint count and swollen joint count, 28 joints of the shoulder, elbow, wrist, metacarpophalangeal joints, thumb interphalangeal joints, proximal interphalangeal joints, and knee joints were examined.
A participant was considered to be in remission if all the criteria for each variable was met:TJC (in 28 joints) ≤1; SJC (in 28 joints) ≤1; CRP ≤1 mg/dl; PtGADA ≤1.
Last Observation Carried Forward (LOCF) was applied"|Week 24 and Week 52|FAS||percentage of participants||95% Confidence Interval|Number
690149|NCT01451203|Secondary|Clinical Remission Rate: Percentage of Participants Meeting the American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Simplified Disease Activity Index (SDAI)-Based Remission Criteria at Weeks 24 and 52|"The ACR/EULAR SDAI remission rate measures the severity of disease at a specific time and is derived from the following variables:
28 tender joint count (TJC);
28 swollen joint count (SJC);
Patient's global assessment of disease activity (PtGADA);
Physician’s Global Assessment of Disease Activity (PhGADA);
C-reactive protein (CRP)
To obtain the tender joint count and swollen joint count, 28 joints of the shoulder, elbow, wrist, metacarpophalangeal joints, thumb interphalangeal joints, proximal interphalangeal joints, and knee joints were examined.
A participant was considered to be in remission if SDAI ≤3.3.
Last Observation Carried Forward (LOCF) was applied."|Week 24 and Week 52|FAS||percentage of participants||95% Confidence Interval|Number
690150|NCT01451203|Secondary|Clinical Remission Rate: Percentage of Participants Meeting the Disease Activity Score-28 Joint Count (DAS28) Erythrocyte Sedimentation Rate (ESR) (DAS28[ESR]) Remission Criteria at Weeks 24 and 52|"The DAS28(ESR) measures the severity of disease at a specific time and is derived from the following variables:
28 tender joint count (TJC);
28 swollen joint count (SJC);
ESR;
Patient's global assessment of disease activity (PtGADA).
To obtain the tender joint count and swollen joint count, 28 joints of the shoulder, elbow, wrist, metacarpophalangeal joints, thumb interphalangeal joints, proximal interphalangeal joints, and knee joints were examined.
DAS28(ESR) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible ESR. A participant was considered to be in remission if DAS28(ESR) <2.6.
Last Observation Carried Forward” (LOCF) was applied."|Week 24 and Week 52|FAS||percentage of participants||95% Confidence Interval|Number
690151|NCT01451203|Secondary|Change From Baseline in mTSS at Week 24|"Radiographs/X-rays of hands and feet (posteroanterior views of both hands and dorsoplantar views of both feet) were independently assessed by two radiographic readers. The degree of joint damage was graded by assessing bone erosion in 44 joints and joint space narrowing (JSN) in 42 joints.
The bone erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints in the feet. Each joint was scored, according to the surface area involved, from 0 (no erosion) to 5 (complete collapse of bone). The score for erosion ranges from 0 to 160 in the hands and from 0 to 120 in the feet (the maximum erosion score for a joint in the foot is 10). The JSN score summarizes the severity of JSN in 30 joints of the hands and 12 joints of the feet. JSN, including subluxation, was scored from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. The mTSS ranges from 0 (normal) to 448 (worst)."|Baseline and Week 24|FAS with available data.||units on a scale||Standard Deviation|Mean
690152|NCT01451203|Primary|Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52|"Radiographs/X-rays of hands and feet (posteroanterior views of both hands and dorsoplantar views of both feet) were independently assessed by two radiographic readers. The degree of joint damage was graded by assessing bone erosion in 44 joints and joint space narrowing (JSN) in 42 joints.
The bone erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints in the feet. Each joint was scored, according to the surface area involved, from 0 (no erosion) to 5 (complete collapse of bone). The score for erosion ranges from 0 to 160 in the hands and from 0 to 120 in the feet (the maximum erosion score for a joint in the foot is 10). The JSN score summarizes the severity of JSN in 30 joints of the hands and 12 joints of the feet. JSN, including subluxation, was scored from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. The mTSS ranges from 0 (normal) to 448 (worst)."|Baseline and Week 52|FAS with available data.||units on a scale||Standard Deviation|Mean
690153|NCT01450813|Secondary|The Average CVI During the Maintenance Phase of Anesthesia for the Two Remifentanil Groups|Mean CVI from incision to propofol off reported as the mean CVI +/- 95% confidence interval for the two groups|Maintenance Anesthesia|||units on a scale||95% Confidence Interval|Mean
690154|NCT01450813|Primary|The Mean Difference in CVI Between Pre-laryngoscopy and Post-laryngoscopy for Each of the Four Rocuronium Groups|"The difference between the mean CVI in three minutes prior to laryngoscopy and three minutes following laryngoscopy reported as the mean change in CVI and the +/- 95% confidence interval for each group.
The Composite Variability Index (CVI) scale is a logistic regression of three measures of processed electroencephalography (EEG) signals. These signals are Bispectral Index (BIS), the variability of electromyelogram (sEMG), and the variability of BIS (sBIS). The scale ranges from 0 to 100 where a lower CVI value represents a lower likelihood of intraoperative somatic responses, and a higher CVI value represents a higher likelihood of intraoperative somatic responses."|Six minutes after the dose of rocuronium with laryngoscopy at 3 minutes after the study intervention|||units on a scale||95% Confidence Interval|Mean
695706|NCT01386632|Secondary|Health-related Quality of Life Among Study Patients by Treatment Arm .||5 year||||||
690155|NCT01450800|Other Pre-specified|Antibiotic Resistance to Macrobid|We examined for macrobid resistance on urine culture results within 3 weeks of surgery|6 weeks after surgery|Examined urine cultures with susceptibility testing results for all participants who had positive urine culture results||urine culture resistant to nitrofurantoi|||Number
690156|NCT01450800|Secondary|Other Risk Factors for UTI|We examined risk of UTI as related to postoperative catheter type|3 weeks following surgery|Used entire study population to determine risk factors for UTI||participants|||Number
690157|NCT01450800|Secondary|Other Risk Factors for UTI|We examined risk of UTI as related to total postoperative catheter days|3 weeks following surgery|Used entire study population to determine risk factors for UTI||days of catheterization||95% Confidence Interval|Median
690158|NCT01450800|Secondary|Other Risk Factors for UTI|We examined risk of UTI as related to sling as part of surgery|3 weeks following surgery|Used entire study population to determine risk factors for UTI||participants|||Number
690159|NCT01450800|Secondary|Other Risk Factors for UTI|We examined risk of UTI as related to Creatinine Clearance|3 weeks following surgery|Used entire study population to determine risk factors for UTI||mL/min||Standard Deviation|Mean
690160|NCT01450800|Secondary|Other Risk Factors for UTI|We examined risk of UTI as related to preoperative UTI treatment|3 weeks following surgery|Used entire study population to determine risk factors for UTI||participants|||Number
690161|NCT01450800|Secondary|Other Risk Factors for UTI|We examined risk of UTI as related to history of recurrent UTIs|3 weeks following surgery|Used entire study population to determine risk factors for UTI||participants|||Number
690162|NCT01450800|Secondary|Other Risk Factors for UTI|We examined risk of UTI as related to vaginal estrogen therapy|3 weeks following surgery|Used entire study population to determine risk factors for UTI||participants|||Number
690163|NCT01450800|Primary|Urinary Tract Infections|The primary outcome was treatment for UTI within the first 3 weeks after surgery. Treatment for UTI was defined to include any treatment received for clinically suspected or culture-proven urinary tract infection within 3 weeks of surgery. Clinically suspected treatment was defined to include treatment given empirically upon development of urinary symptoms or prescribed based on urine test results. Culture-proven UTI was defined as a urine culture with greater than 100,000 colony-forming units of a single organism.|three weeks post-operative|Intent-to-treat analysis||participants|||Number
690164|NCT01450787|Other Pre-specified|Corneal Staining|Corneal staining with fluorescein solution is graded at the time of the exam on a scale of 0 to 5 using the oxford scoring system with 5 being the most severe staining.|at the time of the exam|All patients underwent corneal staining evaluations using fluorescein.||units on a scale|Participants|Standard Error|Mean
690165|NCT01450787|Other Pre-specified|Tear Break-up Time|The tear break-up time with fluorescein solution is measured at the time of the exam in seconds.|at the time of the exam|Each patient underwent tear break-up time testing||seconds|Participants|Standard Error|Mean
690166|NCT01450787|Other Pre-specified|Schirmer Score|The schirmer tear production test with anesthesia is completed at the time of the exam in mm of tear film absorption on the test strip after five minutes. Higher scores represent greater tear production.|at the time of the exam|Each patient underwent schirmer testing||mm|Participants|Standard Error|Mean
690167|NCT01450787|Other Pre-specified|OSDI Score|The ocular surface disease index survey in completed at the time of the exam. This scale ranges from 0 to 100 higher scores representing greater disability.|at the time of the exam|All patients completed the OSDI survey||units on a scale||Standard Error|Mean
690168|NCT01450787|Secondary|Tear Film Osmolarity|The tear film osmolarity is measured at the time of the exam.|at the time of the exam|Tear film osmolarity was measured in all patients, but two patients in the diabetic group had an insufficient tear film to obtain a reading. Therefore, only 36 diabetics were included.||mOsml/L|Participants|Standard Error|Mean
690169|NCT01450787|Primary|Conjunctival Staining Score|Conjunctival staining with lissamine green dye is measured at the time of the evaluation on a scale from 0 to 5 using the oxford scoring system, with 5 being the most severe staining.|at the time of the evaluation|There were 38 consecutive diabetics over 40 years of age and 25 consecutive non-diabetics over 40 years of age that qualified and agreed to enroll. A target of 25 non-diabetics was met. The target of 50 was not met as the study was stopped when the PI changed practices. By that time, 38 diabetics enrolled.||units on a scale|Participants|Standard Error|Mean
690170|NCT01450761|Secondary|Progression Free Survival (PFS) Time in Participants Who Have Received at Least One Dose of Blinded Study Therapy|Progression-Free Survival was defined as the time from the date of randomization to the date of progression per modified World Health Organization (mWHO) criteria or death, whichever occured first. A participant who died without reported progression per mWHO criteria was considered progressed on the date of death. For those participants who remained alive and did not progress, PFS was censored on the date of last evaluable tumor assessment. For those participants who remained alive and had no recorded post-baseline tumor assessment, PFS was censored on the day of randomization.|From randomization until disease progression, up to March 2015, approximately 38 months|All randomized participants who received at least one dose of blinded study therapy||months||95% Confidence Interval|Median
690171|NCT01450761|Secondary|Overall Survival in All Randomized Participants|Overall Survival was defined as the time from the date of randomization until the date of death from any cause. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.|From randomization until date of death, up to March 2015, approximately 38 months|All randomized participants||months||95% Confidence Interval|Median
690172|NCT01450761|Primary|Overall Survival (OS) in Participants Who Received at Least One Dose of Blinded Study Therapy|Overall Survival was defined as the time from the date of randomization until the date of death from any cause. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.|Randomization until date of death, up to March 2015, approximately 38 months|All randomized participants who received at least one dose of blinded study therapy||months||95% Confidence Interval|Median
690185|NCT01450397|Primary|The Measured Change in Volume of the Cord by MRI Before and After XIAFLEX Injection and Manual Manipulation.|Change in Volume (millimeter cubed) of the Cord by MRI between Baseline and 30 days after XIAFLEX injection and manual manipulation.|Baseline and 30 days|||mm^3||Full Range|Mean
690186|NCT01450319|Secondary|Beta 2-microglobulin||Baseline, Week 8|"MITT analysis set included all the subjects who received study drug treatment. Here n signifies number of evaluable subjects for each category, as specified."||microgram per milliliter (mcg/mL)||Standard Deviation|Mean
690173|NCT01450696|Secondary|Trastuzumab Serum Concentration on Day 1 of Cycle 1 - FAS|Trastuzumab serum concentration samples were obtained in all participants randomized to receive Herceptin (FAS). The observed concentration values were recorded, averaged among all participants, and expressed in μg/mL.|Pre-dose (0 minutes) and within 15 minutes after end of 2-hour Herceptin infusion on Day 1 of Cycle 1 (cycle length = 21 days)|"FAS population. Here, number of participants analyzed reflects the number of participants who were evaluable for this outcome measure. Here also, n reflects the number of participants who were evaluable for each category in the respective arms."||μg/mL||Standard Deviation|Mean
690174|NCT01450696|Secondary|Trastuzumab Cmin on Day 21 of Cycles 1 to 11 - FAS|Cmin samples were obtained in all participants randomized to receive Herceptin (FAS). The observed Cmin was recorded, averaged among all participants, and expressed in μg/mL.|Day 21 of Cycle 1, 2, 3, 4, 5, 7, 9, 11 (cycle length = 21 days)|FAS population. Here, number of participants analyzed reflects the number of participants who were evaluable for this outcome measure. Here also, “n” reflects the number of participants who were evaluable for each category in the respective arms.||μg/mL||Standard Deviation|Mean
690175|NCT01450696|Secondary|Percentage of Participants With Objective Response - PPS|Objective response was defined as the occurrence of either a complete response (CR) or partial response (PR) as determined by RECIST Version 1.1 based on investigator assessment. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) were required to have reduction in short axis to <10 mm. PR was defined as a ≥30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters. The 95% CI was constructed using Blyth-Still-Casella method.|From date of randomization until first occurrence of disease progression or death; assessed every 6 weeks (up to approximately 31 months or data cutoff date of 13 February 2015)|PPS population.||percentage of participants||95% Confidence Interval|Number
690176|NCT01450696|Secondary|Progression-Free Survival - PPS|Progression-free survival was defined as the time between the day of randomization and the date of first documentation of disease progression or date of death, whichever occurred first, measured following RECIST Version 1.1 criteria. Disease progression was defined as a ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including Baseline (nadir). In addition to the relative increase of 20%, the sum was also required to demonstrate an absolute increase of ≥5 mm. The 95% CI for median was computed using the method of Brookmeyer and Crowley.|From date of randomization until first occurrence of disease progression or death; assessed every 6 weeks (up to approximately 31 months or data cutoff date of 13 February 2015)|PPS population.||months||95% Confidence Interval|Median
690177|NCT01450696|Secondary|Percentage of Participants With Disease Progression or Death - PPS|Disease progression was defined by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as a ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including Baseline (nadir). In addition to the relative increase of 20%, the sum was also required to demonstrate an absolute increase of ≥5 millimeters (mm). The percentage of participants who died or experienced disease progression as of the analysis data cutoff date of 13 February 2015 was reported among participants from the PPS.|From date of randomization until first occurrence of disease progression or death; assessed every 6 weeks (up to approximately 31 months or data cutoff date of 13 February 2015)|PPS population.||percentage of participants|||Number
690178|NCT01450696|Secondary|Overall Survival - PPS|Overall survival was defined as the time from the date of randomization to the date of death from any cause. Overall survival was estimated among participants from the PPS using the Kaplan-Meier approach. The 95% CI for median was computed using the method of Brookmeyer and Crowley.|From date of randomization until death or premature withdrawal (up to approximately 31 months or data cutoff date of 13 February 2015)|PPS population.||months||95% Confidence Interval|Median
690179|NCT01450696|Secondary|Percentage of Participants Who Died - Per Protocol Set (PPS)|The percentage of participants who died as of the analysis data cutoff date of 13 February 2015 was reported among participants from the PPS.|From date of randomization until death or premature withdrawal (up to approximately 31 months or data cutoff date of 13 February 2015)|The PPS included all participants who were found to have a trastuzumab minimum plasma concentration (Cmin) less than (<) 12 micrograms per milliliter (μg/mL) on treatment Day 21 of Cycle 1 following the initial loading dose of 8 mg/kg.||percentage of participants|||Number
690180|NCT01450696|Primary|Overall Survival - FAS|Overall survival was defined as the time from the date of randomization to the date of death from any cause. Overall survival was estimated among participants from the FAS using the Kaplan-Meier approach. The 95 percent (%) confidence interval (CI) for median was computed using the method of Brookmeyer and Crowley.|From date of randomization until death or premature withdrawal (up to approximately 31 months or data cutoff date of 13 February 2015)|FAS population. Here, number of participants analyzed reflects the number of participants who were evaluable for this outcome measure.||months||95% Confidence Interval|Median
690181|NCT01450696|Primary|Percentage of Participants Who Died - FAS|The percentage of participants who died as of the analysis data cutoff date of 13 February 2015 was reported among participants from the FAS with available data.|From date of randomization until death or premature withdrawal (up to approximately 31 months or data cutoff date of 13 February 2015)|FAS population. Here, number of participants analyzed reflects the number of participants who were evaluable for this outcome measure.||percentage of participants|||Number
690182|NCT01450683|Primary|Reduction in Serum PSA|Number of subjects with > 50% drop in serum PSA as compared to baseline, at 12 weeks and confirmed at 15 weeks|12 weeks treatment, with primary outcome assessed at 15 weeks|||participants|||Number
690183|NCT01450631|Secondary|Incidence Rate of Surgical Incision Intervention (SII) up to Day 42 (+/- 10 Days) Post Cesarean Section Surgery.|"Incidence rate of surgical incision intervention (SII) post Cesarean section surgery. Interventions include:
Antimicrobials for surgical site infection
Surgical drainage of the incision
Surgical incision packing
Adjunctive negative pressure therapy
Debridement
Re-operation"|Post-op Day: 42 (+/- 10 days) after Cesarean section surgery|The Per-protocol Population was used for primary and secondary endpoint analysis.||participants|||Number
690184|NCT01450631|Primary|Incidence of Postoperative Surgical Site Occurrences (SSOs) up to Day 42 (+/- 10 Days) Post Cesarean Section Surgery.|"Incidence of postoperative surgical site occurrences (SSOs) post Cesarean section surgery. SSOs include:
Unanticipated local inflammatory response
Prolonged drainage
Fluid collection
Dehiscence
Surgical site infection (SSI)"|Post-op Day 42 (+/- 10 days) after Cesarean section surgery|The Per-protocol Population was used for primary and secondary endpoint analysis.||participants|||Number
690187|NCT01450319|Secondary|Overall Survival (OS) Related to Killer Inhibitory Receptors 2DS4 (KIR2DS4) Functional Receptor (f/d) and Non-functional Receptor (NFR)|OS was defined as the time from informed consent signature until death. Subjects without death were censored at the last date known alive (within the study).|From the date of informed consent signature until death, lost-to-follow-up or end of study, whatever occurred first (maximal assessed up to 3 years)|"MITT analysis set included all the subjects who received study drug treatment. Here Number of subjects analyzed signifies number of evaluable subjects for this outcome measure."||months||95% Confidence Interval|Median
690188|NCT01450319|Secondary|Overall Survival (OS) Related to Codon G13D|OS was defined as the time from informed consent signature until death. Subjects without death were censored at the last date known alive (within the study).|From the date of informed consent signature until death, lost-to-follow-up or end of study, whatever occurred first (maximal up to 3 years)|"MITT analysis set included all the subjects who received study drug treatment. Here Number of subjects analyzed signifies total number of evaluable subjects for this outcome measure; “n” signifies number of evaluable subjects for each category, as specified."||months||95% Confidence Interval|Median
690189|NCT01450319|Secondary|Number of Subjects With Fcγ Receptors (FCγR) IIa/IIIa Polymorphisms|The antibody fragment C portion (FCy) of cetuximab interacts with Fc-gamma receptors (FCyRs) expressed by immune effector cells. Polymorphisms were described in genes coding for FCyRIIa and in FCyRIIIa. A histidine/arginine polymorphism at position 131 for FCyRIIa gene and valine ⁄ phenylalanine polymorphism at position 158 for the FCyRIIIa gene were reported to be functionally relevant in the ADCC mechanism. All subjects were analyzed and classified as carriers of every different polymorphism of FCy Receptors: for FCyRIIa (H/H, homozygous alleles with histidine and R/H, heterozygous alleles with arginine/histidine) and FCyRIIIa (V/V, homozygous alleles with valine, F/F, homozygous alleles with phenylalanine and F/V, heterozygous alleles with valine ⁄ phenylalanine) (units: subjects with every type of polymorphism) .The FCyR genotype was determined using a TaqMan Allelic Discrimination Assay.|Baseline|MITT analysis set included all the subjects who received study drug treatment. Subjects may fall into more than one category.||Subjects|||Number
690190|NCT01450319|Secondary|Number of Subjects With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Discontinuation, AEs Leading to Death|An AE was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A SAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|From the date of enrollment up to 30 days after the last dose of study drug administration, assessed up to 3 years|Safety analysis set included all the subjects who received at least one dose of the study drug treatment.||Subjects|||Number
690191|NCT01450319|Secondary|Progression Free Survival (PFS) Time|PFS was defined as the time from informed consent signature until PD or death, whatever occurred first. Subjects who did not have disease progression or were lost to follow-up, were censored at the date of last contact, known to be alive and progression free; moreover, those subjects who started a new treatment (different from cetuximab), were censored at the date of starting the new treatment. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from BL or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented.|From the date of informed consent signature until progressive disease (PD) or death, assessed up to 3 years|MITT analysis set included all the subjects who received study drug treatment.||Months||95% Confidence Interval|Median
690192|NCT01450319|Secondary|Percentage of Subjects With Disease Control Rate (DCR)|DCR was defined as those subjects achieving complete response (CR), partial response (PR) or stable disease (SD), according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v.1.1). For target lesions (TLs), CR was defined as the disappearance of all TLs; PR was defined as at least a 30 percent (%) decrease in the sum of longest diameter (SLD) of the TLs, taking as a reference the baseline (BL) SLD; Stable disease (SD) was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For non-target lesions (NTLs), CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits; and progressive disease (PD) was defined as the appearance|From the date of informed consent signature until progressive disease, assessed up to 3 years|MITT analysis set included all the subjects who received study drug treatment.||Percentage of subjects|||Number
690193|NCT01450319|Primary|Overall Survival (OS) Time|Overall survival was defined as the time from date of informed consent signature until death.|From the date of informed consent signature until death, assessed up to 3 years|MITT analysis set included all the subjects who received study drug treatment.||Months||95% Confidence Interval|Median
690194|NCT01450306|Secondary|Clinician's Global Impression (CGI)-Improvement|"Clinician rating of global illness severity (at post-treatment)
CGI-Improvement range 1-7; higher scores indicate poorer improvement; classified as responder if score = 1 or 2, nonresponder if score > 2"|2 weeks|||participants|||Number
690195|NCT01450306|Secondary|Clinician's Global Impression (CGI)-Severity|"Clinician rating of global illness severity (at pre- and post-treatment)
CGI-Severity range 1-7; higher scores indicate greater illness severity."|2 weeks|||units on a scale||Standard Deviation|Mean
690196|NCT01450306|Primary|Snake Questionnaire (SNAQ)|"30-item self-report scale of severity of snake fear and avoidance
Range: 0-30; higher values indicate greater fear severity"|2 weeks|||units on a scale||Standard Deviation|Mean
690197|NCT01450189|Secondary|Genital HIV RNA Concentration - Week 52, Men|median HIV RNA concentration as measured in semen|52 weeks|Number includes enrolled men who had a genital HIV RNA sample obtained during the window for this visit.||copies/ml||Full Range|Median
690198|NCT01450189|Secondary|Genital HIV RNA Concentration - Week 26, Men|median HIV RNA concentration as measured in semen|26 weeks|Number includes enrolled men who had a genital HIV RNA sample obtained during the window for this visit.||copies/ml||Full Range|Median
695707|NCT01386632|Secondary|Health-related Quality of Life Among Study Patients by Treatment Arm.||2 year||||||
690199|NCT01450189|Secondary|Genital HIV RNA Concentration - Week 12, Men|median HIV RNA concentration as measured in semen|12 weeks|Number includes enrolled men who had a genital HIV RNA sample obtained during the window for this visit.||copies/ml||Full Range|Median
690200|NCT01450189|Secondary|Genital HIV RNA Concentration - Week 52, Women|median HIV RNA concentration in cervical lavage fluid|52 weeks|Number includes enrolled women who had a genital HIV RNA sample obtained during the window for this visit.||copies/ml||Full Range|Median
690201|NCT01450189|Secondary|Genital HIV RNA Concentration - Week 26, Women|median HIV RNA concentration in cervical lavage fluid|26 weeks|Number includes enrolled women who had a genital HIV RNA sample obtained during the window for this visit.||copies/ml||Full Range|Median
690202|NCT01450189|Secondary|Genital HIV RNA Concentration - Week 12, Women|median HIV RNA concentration in cervical lavage fluid|12 weeks|Number includes enrolled women who had a genital HIV RNA sample obtained during the window for this visit.||copies/ml||Full Range|Median
690203|NCT01450189|Secondary|Blood HIV RNA Concentration at Week 52||52 weeks|Number includes enrolled persons who had an HIV RNA (blood) specimen available the window for this visit.||copies/ml||Full Range|Median
690204|NCT01450189|Secondary|Blood HIV RNA Concentration at Week 26||26 weeks|Number includes enrolled persons who had an HIV RNA (blood) specimen available the window for this visit.||copies/ml||Full Range|Median
690205|NCT01450189|Secondary|Blood HIV RNA Concentration at Week 12||12 weeks|Number includes enrolled persons who had an HIV RNA (blood) specimen available the window for this visit.||copies/ml||Full Range|Median
690206|NCT01450189|Secondary|Time to HIV RNA Suppression <1000 c/ml|median time to viral load suppression (<1000 c/ml)|From date of randomization until viral load suppression, up to 52 weeks|||weeks||95% Confidence Interval|Median
690207|NCT01450189|Secondary|Suppression of HIV RNA to <1000c/ml at 12 Weeks|Proportion of persons in each arm with viral load <1000copies/ml at 12 weeks|12 weeks|||Proportion of participants||95% Confidence Interval|Number
690208|NCT01450189|Secondary|Proportion of Partners Reporting for HIV Testing|Proportion of sexual partners reporting for HIV testing among all sexual partners named by the index participants|52 weeks|The number of sexual partners named by the index participants is the denominator. For example, the 9 index participants in the standard arm named 35 partners. 4 partners presented, giving a proportion of 0.1 (4/35)||proportion of sex partners|sexual partners|95% Confidence Interval|Number
690209|NCT01450189|Secondary|Number of Partners Reporting for HIV Testing|Number of partners per index reporting for HIV testing at any time during follow-up|52 weeks|||partners per index participant||95% Confidence Interval|Mean
690210|NCT01450189|Secondary|Cumulative Incidence Herpes Simplex Virus Type 2|cumulative incidence of herpes simplex virus type 2, assessed at 52 weeks. Persons with baseline positivity were excluded.|52 weeks|Number includes all persons who were confirmed HSV-2 negative at baseline and who had an informative test on or before Week 52||Proportion of participants||95% Confidence Interval|Number
690211|NCT01450189|Secondary|Cumulative Incidence Herpes Simplex Virus Type 2|cumulative incidence of herpes simplex virus type 2, assessed at 26 weeks. Persons with baseline positivity were excluded.|26 weeks|Number includes all persons who were confirmed HSV-2 negative at baseline and who had an informative test on or before Week 26||Proportion of participants||95% Confidence Interval|Number
690212|NCT01450189|Secondary|Cumulative Incidence of Gonorrhea, Chlamydial Infection and Trichomoniasis (Composite)|At least one incident infection with either gonorrhea, chlamydia or trichomoniasis|52 weeks|Number includes all persons with gonorrhea, chlamydia, and trichomoniasis results and who had at least one visit after Week 26||proportion of participants||95% Confidence Interval|Number
690213|NCT01450189|Secondary|Cumulative Incidence of Gonorrhea, Chlamydial Infection and Trichomoniasis (Composite)|Cumulative incidence, definied as at least one incident infection with either gonorrhea, chlamydia or trichomoniasis|26 weeks|Number includes all persons with gonorrhea, chlamydia, and trichomoniasis results who had not withdrawn from the study by the first scheduled STI tests||proportion of participants||95% Confidence Interval|Number
690214|NCT01450189|Secondary|Unprotected Sex Acts in Previous One Month - 52 Weeks|The mean number of unprotected sex acts in previous one month, assessed at 52 weeks|52 weeks|Number includes enrolled persons who completed the ACASI interview within the window for this visit||unprotected sex acts/month||95% Confidence Interval|Mean
690215|NCT01450189|Secondary|Unprotected Sex Acts in Previous One Month - 26 Weeks|The mean number of unprotected sex acts in previous one month, assessed at 26 weeks|26 weeks|Number includes enrolled persons who completed the ACASI interview within the window for this visit||unprotected sex acts/month||95% Confidence Interval|Mean
690216|NCT01450189|Secondary|Unprotected Sex Acts in Previous One Month - 12 Weeks|The mean number of unprotected sex acts in previous one month, assessed at 12 weeks|12 weeks|Number includes enrolled persons who completed the ACASI interview within the window for this visit||unprotected sex acts/month||95% Confidence Interval|Mean
690217|NCT01450189|Secondary|Unprotected Sex Acts in Previous One Week - 52 Weeks|The mean number of unprotected sex acts in previous one week, assessed at 52 weeks|52 weeks|Number includes enrolled persons who completed the ACASI interview within the window for this visit||unprotected sex acts/week||95% Confidence Interval|Mean
690218|NCT01450189|Secondary|Unprotected Sex Acts in Previous One Week - 26 Weeks|The mean number of unprotected sex acts in previous one week, assessed at 26 weeks|26 weeks|Number includes enrolled persons who completed the ACASI interview within the window for this visit||unprotected sex acts/week||95% Confidence Interval|Mean
690219|NCT01450189|Secondary|Unprotected Sex Acts in Previous One Week - 12 Weeks|The mean number of unprotected sex acts in previous one week, assessed at 12 weeks|12 weeks|Number includes enrolled persons who completed the ACASI interview within the window for this visit||unprotected sex acts/week||95% Confidence Interval|Mean
690220|NCT01450189|Primary|Number of Adverse Events|Mean number of adverse events per group|one year|||number of events||95% Confidence Interval|Mean
690221|NCT01450189|Primary|Proportion of Persons Completing All Scheduled Visits in Each Study Arm||1 year|||Proportion of participants||95% Confidence Interval|Number
690222|NCT01450189|Primary|Proportion of Participants in Arm BI and BIA (Combined) Who Complete the 4 Behavioral Sessions Within 3 Weeks of Enrollment.|In this pilot study, we addressed our ability to complete the behavioral intervention quickly. As two arms received the behavioral intervention, this outcome is combined across those two arms.|1 year|All persons in the two behavioral intervention arms||proportion of participants||95% Confidence Interval|Number
690223|NCT01450189|Primary|Proportion of Participants Completing Full Course of ARVs in Arm BIA|Proportion of participants in the BIA arm receiving full course of ARVs. This outcome is calculated among the BIA arm only, as that|1 year|Number of persons in BIA arm eligible for study-provided ARVs||proportion of BIA participants||95% Confidence Interval|Number
690224|NCT01450189|Primary|Proportion of Persons With AHI Successfully Recruited Into the Study|This outcome reflects the ability to recruit persons with AHI into a study. The outcome is based on the population prior to randomization.|1 year|||Proportion of persons with AHI recruited||95% Confidence Interval|Number
690225|NCT01450189|Primary|Prevalence of AHI Among Persons Screened|Prevalence of AHI among all persons screened. This measure is among all persons screened, prior to randomization.|1 year|||proportion of participants||95% Confidence Interval|Number
690226|NCT01450189|Primary|Proportion of Persons Agreeing to be Screened for Acute HIV Infection Among Those Offered Screening||1 year|All persons screened||proportion of participants screened||95% Confidence Interval|Number
690227|NCT01450007|Secondary|Patient Satisfaction With Pain Control|Pain was rated on a visual analogue scale with 0 = no pain, 3=mild pain, 5=moderate pain, 7=moderate to severe pain, and 10=severe pain.|24 hours, 48 hours, 1 week|Patients analyzed for each category varied see explanations per row (time point): (n=dexamethasone block, dexamethasone IV, placebo).||units on a scale||Standard Deviation|Mean
690228|NCT01450007|Secondary|Time Until First Dose of Analgesic||Approximately 10 hours after surgery|The number of participants analyzed is different from the number of participants in each arm who completed the trial because data were not available for 1 participant in the Dexamethasone IV group and 1 participant in the placebo group.||hours||Standard Deviation|Mean
690229|NCT01450007|Secondary|Post Operative Opioid Dose at 24 Hours||approximately 24 hours after surgery|The number of participants analyzed is different from the number of participants in each arm who completed the trial because data were not available for 1 participant in the Dexamethasone IV group and 1 participant in the placebo group.||mg morphine equivalents||Standard Deviation|Mean
690230|NCT01450007|Primary|Duration of Sensory Blockade|Duration from time of block until complete resolution of sensory blockade in the shoulder is recorded in minutes by patient report.|Within 48 hours|Patients will be included in the primary analysis on the basis of intention to treat.||hours||Standard Deviation|Mean
690231|NCT01449955|Secondary|PTSD Checklist (PCL)|Self-report measure of the intensity of PTSD symptoms|change in PCL score from baseline to one week posttreatment||||||
690232|NCT01449955|Secondary|Psychophysiological Measurements: Electromyogram|The participant's left lateral frontalis and left corrugator muscle activity is monitored during a script-driven imagery procedure. This procedure involves listening to 4 scripts: 2 neutral, 2 combat-related|one week after medication||||||
690233|NCT01449955|Secondary|Psychophysiology Measurements: Skin Conductance|The participant's skin conductance response is monitored during a script-driven imagery procedure. This procedure involves listening to 4 scripts: 2 neutral, 2 combat-related|one week after medication||||||
690234|NCT01449955|Secondary|Psychophysiology Measurements: Heart Rate|The participant's heart rate is monitored during a script-driven imagery procedure. This procedure involves listening to 4 scripts: 2 neutral, 2 combat-related.|one week after medication||||||
690235|NCT01449955|Secondary|Quick Inventory of Depressive Symptomatology (QIDS)|Self-report measure of depressive symptoms|change in QIDS score from baseline to 1 week posttreatment||||||
690236|NCT01449955|Secondary|Quick Inventory of Depressive Symptomatology (QIDS)|Self-report measure of depressive symptoms|change in QIDS score from baseline to 3 months posttreatment||||||
690237|NCT01449955|Secondary|Quick Inventory of Depressive Symptomatology (QIDS)|Self-report measure of depressive symptoms|change in QIDS score from baseline to 1 month posttreatment||||||
690238|NCT01449955|Secondary|PTSD Checklist (PCL)|Self-report measure of the intensity of PTSD symptoms|change in PCL score from baseline to 3 months posttreatment||||||
690239|NCT01449955|Secondary|PTSD Checklist (PCL)|Self-report measure of the intensity of PTSD symptoms|change in PCL score from baseline to 1 month posttreatment||||||
690240|NCT01449955|Primary|Clinician Administered Posttraumatic Stress Disorder Scale (CAPS)|The CAPS is administered to assess the frequency and intensity of PTSD symptoms at baseline, and then again 3 months posttreatment.|change in CAPS score from baseline to 3 months posttreatment||||||
690241|NCT01449955|Primary|Clinician Administered Posttraumatic Stress Disorder Scale (CAPS)|Clinician administered interview which assesses the symptoms of Posttraumatic Stress disorder at baseline, and then again 1 month posttreatment. The CAPS is a 25 item semi-structured interview that assesses the 17 DSM-IV PTSD criteria as well as social and occupational impairment. For each item the participant can respond with a rating of 0-8 (with 0 indicating no symptom severity and frequency and 8 indicating extreme symptom severity and frequency). The range of total scores on a CAPS is from 0-136, with a greater score indicating greater PTSD symptom severity. The total score is computed by summing the aforementioned 17 items. Additionally, the CAPS assesses for a positive PTSD diagnosis by assessing for the three DSM-IV criteria of B, C, and D. In order to meet a positive screen for each criteria, a person must screen positive for symptoms by reporting a score of 3 or more on the specific symptom criterion.|Baseline and 1 month posttreatment|||scores on a scale||Standard Deviation|Mean
690371|NCT01449279|Secondary|Median Time to Complete Response or Partial Response|Time from the first dose of ipilimumab to the first tumor measurement showing either a complete or partial response to therapy.|2 to 4 weeks after last ipilimumab and then every 3 months until disease progression.|All patients who had either a complete response or partial response.||weeks||95% Confidence Interval|Median
695708|NCT01386632|Secondary|Health-related Quality of Life Among Study Patients by Treatment Arm .||1 year||||||
690258|NCT01449812|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Month 0 up to Month 1)|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who had received the booster dose and for whom data were available.||Participants|||Count of Participants
690259|NCT01449812|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Days 0-30) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who had received the booster dose and for whom data were available.||Participants|||Count of Participants
690260|NCT01449812|Secondary|Number of Subjects With Any Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above 37.1 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade and relationship to vaccination.|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with the symptoms sheet filled in, who had received the booster dose and for whom data were available.||Participants|||Count of Participants
690261|NCT01449812|Secondary|Number of Subjects With Any Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with the symptoms sheet filled in, who had received the booster dose and for whom data were available.||Participants|||Count of Participants
690262|NCT01449812|Primary|Number of Subjects With a Booster Response to Anti-PT, Anti-FHA and Anti-PRN|Booster response was defined as the appearance of antibodies in subjects who were initially seronegative (i.e. with concentrations < cut-off value) or at least maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (i.e. with concentrations ≥ cut-off value), taking into consideration the decreasing maternal antibodies.|One month after the booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.||Participants|||Count of Participants
690263|NCT01449812|Primary|Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrattions|Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL.|One month after the booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
690264|NCT01449812|Primary|Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 5 EL.U/mL.|Before the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
690265|NCT01449812|Primary|Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN|A seropositive subject was defined as a vaccinated subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL.|One month after the booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.||Participants|||Count of Participants
690266|NCT01449812|Primary|Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN|A seropositive subject was defined as a vaccinated subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 ELISA units per milliliter (EL.U/mL).|Before the booster vaccination (At Day 0)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.||Participants|||Count of Participants
690267|NCT01449812|Primary|Anti-polio Type 1, 2 and 3 Antibody Titers|Antibody titers were presented as geometric mean titers (GMTs) for the seroprotection cut-off of ≥ 8.|One month after the booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.||Titers||95% Confidence Interval|Geometric Mean
690268|NCT01449812|Primary|Anti-polio Type 1, 2 and 3 Antibody Titers|Antibody titers were presented as geometric mean titers (GMTs) for the seroprotection cut-off of ≥ the value of 8.|Before the booster vaccination (At Day 0)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.||Titers||95% Confidence Interval|Geometric Mean
690269|NCT01449812|Primary|Number of Seroprotected Subjects Against Polio Type 1, 2 and 3|A seroprotected subject was defined as a vaccinated subject with anti-polivirus antibody concentrations ≥ 8 ED50. ED50 is the estimated serum dilution reducing the signal generated by viral infection with 50%.|One month after the booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.||Participants|||Count of Participants
690270|NCT01449812|Primary|Number of Seroprotected Subjects for Anti-polio Type 1, 2 and 3|A seroprotected subject was defined as a vaccinated subject with anti-polivirus antibody concentration ≥ 8 ED50. ED50 is the estimated serum dilution reducing the signal generated by viral infection with 50%.|Before the booster vaccination (At Day 0)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.||Participants|||Count of Participants
690271|NCT01449812|Primary|Anti-PRP Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 µg/mL.|One month after the booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.||µg/mL||95% Confidence Interval|Geometric Mean
690272|NCT01449812|Primary|Anti-PRP Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 micrograms per milliliter (µg/mL).|Before the booster vaccination (At Day 0)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.||µg/mL||95% Confidence Interval|Geometric Mean
690273|NCT01449812|Primary|Number of Seroprotected Subjects Against PRP|A seroprotected subject was defined as a vaccinated subject with anti-PRP antibody concentrations ≥ 0.15 µg/mL.|One month after the booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.||Participants|||Count of Participants
690274|NCT01449812|Primary|Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP)|A seroprotected subject was defined as a vaccinated subject with anti-PRP antibody concentration ≥ 0.15 µg/mL.|Before the booster vaccination (At Day 0)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.||Participants|||Count of Participants
690275|NCT01449812|Primary|Anti-D and Anti-T Antibody Concentrations|Antibody concentrations were presented as GMCs for the seroprotection cut-off of ≥ 0.1 IU/mL.|One month after the booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.||IU/mL||95% Confidence Interval|Geometric Mean
690276|NCT01449812|Primary|Anti-D and Anti-T Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.1 IU/mL.|Before the booster vaccination (At Day 0)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.||IU/mL||95% Confidence Interval|Geometric Mean
690277|NCT01449812|Primary|Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoids|A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations ≥ 0.1 IU/mL.|One month after the booster vaccination (At Month 1)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.||Participants|||Count of Participants
690278|NCT01449812|Primary|Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoids|A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 IU/mL.|Before the booster vaccination (At Day 0)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.||Participants|||Count of Participants
690279|NCT01449812|Primary|Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL.|Before the booster vaccination (At Day 0)|The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of antibody persistence, which included all subjects who have completed their full three-dose primary vaccination course in the DTPA-IPV-056 study and for whom serological results were available at the persistence time point.||EL.U/mL||95% Confidence Interval|Geometric Mean
690280|NCT01449812|Primary|Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)|A seropositive subject was defined as a vaccinated subject with anti-PT, anti-FHA and anti-PRN antibody concentration ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/ml).|Before the booster vaccination (At Day 0)|The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of antibody persistence, which included all subjects who have completed their full three-dose primary vaccination course in the DTPA-IPV-056 study and for whom serological results were available at the persistence time point.||Participants|||Count of Participants
690281|NCT01449812|Primary|Anti-polio Type 1, 2 and 3 Antibody Titers|Antibody titers were presented as geometric mean titers (GMTs) for the seroprotection cut-off of ≥ 8.|Before the booster vaccination (At Day 0)|The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of antibody persistence, which included all subjects who have completed their full three-dose primary vaccination course in the DTPA-IPV-056 study and for whom serological results were available at the persistence time point.||Titers||95% Confidence Interval|Geometric Mean
690282|NCT01449812|Primary|Number of Seroprotected Subjects Against Polio Type 1, 2 and 3|A seroprotected subject was defined as a vaccinated subject with anti-polio type 1, 2 and 3 antibody concentrations ≥ the cut-off value of 8 Estimated Dose 50% (ED50). ED50 is the estimated serum dilution reducing the signal generated by viral infection with 50%.|Before the booster vaccination (At Day 0)|The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of antibody persistence, which included all subjects who have completed their full three-dose primary vaccination course in the DTPA-IPV-056 study and for whom serological results were available at the persistence time point.||Participants|||Count of Participants
690426|NCT01447914|Post-Hoc|Cycles of Tivantinib Treatment Administered|Number of treatment cycles completed by study participants.|From start of participant treatment to completion or disease progression; Data collected for overall study period January 2012 to February 2014.|||number of treatment cycles||Full Range|Mean
690283|NCT01449812|Primary|Anti-PRP Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 µg/mL.|Before the booster vaccination (At Day 0)|The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of antibody persistence, which included all subjects who have completed their full three-dose primary vaccination course in the DTPA-IPV-056 study and for whom serological results were available at the persistence time point.||µg/mL||95% Confidence Interval|Geometric Mean
690284|NCT01449812|Primary|Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (Anti-PRP)|A seroprotected subject was defined as a vaccinated subject with anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (µg/mL).|Before the booster vaccination (At Day 0)|The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of antibody persistence, which included all subjects who have completed their full three-dose primary vaccination course in the DTPA-IPV-056 study and for whom serological results were available at the persistence time point.||Participants|||Count of Participants
690285|NCT01449812|Primary|Anti-D and Anti-T Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥0.1 IU/mL.|Before the booster vaccination (At Day 0)|The analysis was performed on the ATP cohort for analysis of antibody persistence, which included all subjects who have completed their full three-dose primary vaccination course in the DTPA-IPV-056 study and for whom serological results were available at the persistence time point.||IU/mL||95% Confidence Interval|Geometric Mean
690286|NCT01449812|Primary|Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids|A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).|Before the booster vaccination (At Day 0)|The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of antibody persistence, which included all subjects who have completed their full three-dose primary vaccination course in the DTPA-IPV-056 study and for whom serological results were available at the persistence time point.||Participants|||Count of Participants
690287|NCT01449747|Primary|Change in AUC of Active GLP-1, Total GLP-1 and Total GIP Between Before and After Sitagliptin Treatment|Plasma concentrations of active GLP-1, total GLP-1 and total GIP were measured at 0, 15, 30, 45, 60, 90, 120 and 180 min during the meal tolerance test. Second measurements were measured with MTT after taking sitagliptin 100 mg 1 hour before the test. Comparisons were made using Area under the curve (AUC) values and incremental area under the curve (ΔAUC) of active GLP-1, total GLP-1 and total GIP before and after the addition of sitagliptin.|0, 15, 30, 45, 60, 90, 120, 180 min pre and post-dose|||pmol*min/L||Standard Deviation|Mean
690288|NCT01449747|Primary|Plasma Concentration of Total Glucose-dependent Insulinotropic Polypeptide (GIP) Before and After Sitagliptin Treatment|Plasma concentrations of total GIP were measured at 0, 15, 30, 45, 60, 90, 120 and 180 min during the meal tolerance test. Second measurement of total GIP were measured with MTT after taking sitagliptin 100 mg 1 hour before the test.|0, 15, 30, 45, 60, 90, 120, 180 min pre and post-dose|||pmol/L||Standard Deviation|Mean
690289|NCT01449747|Primary|Plasma Concentration of Total GLP-1 Before and After Sitagliptin Treatment|Plasma concentrations of total GLP-1 were measured at 0, 15, 30, 45, 60, 90, 120 and 180 min during the meal tolerance test. Second measurement of total GLP-1 were measured with MTT after taking sitagliptin 100 mg 1 hour before the test.|0, 15, 30, 45, 60, 90, 120, 180 min pre and post-dose|||pmol/L||Standard Deviation|Mean
690290|NCT01449747|Secondary|Differences of DPP-4 Activity After Sitagliptin Treatment Between Responder and Non-responder Groups|The DPP-4 activity was measured at baseline and 0, 15, 30, 45 and 60 min during the meal tolerance test. Second measurement of DPP-4 activity was measured with MTT after taking sitagliptin 100 mg 1 hour before the test. Plasma DPP-4 activity during meal tolerance test is expressed as percentage activity relative to baseline. DPP-4 activity % was calculated using the following formula : (DPP-4 activity at time t / Baseline DPP-4 activity) × 100.|0, 15, 30, 45, 60 min post-dose|||percentage of DPP4 activity||Standard Deviation|Mean
690291|NCT01449747|Primary|Plasma Concentration of Active Glucagon-like Peptide 1 (GLP-1) Before and After Sitagliptin Treatment|Plasma concentrations of active GLP-1 were measured at 0, 15, 30, 45, 60, 90, 120 and 180 min during the meal tolerance test (MTT). Second measurement of active GLP-1 were measured with MTT after taking sitagliptin 100 mg 1 hour before the test.|0, 15, 30, 45, 60, 90, 120, 180 min pre and post-dose|||pmol/L||Standard Deviation|Mean
690292|NCT01449734|Primary|Family Satisfaction in the ICU (FS-ICU) Questionnaire- Overall Satisfaction Score|Overall satisfaction score is calculated as the mean of 24 Items concerning satisfaction with care, communication and decision-making. After transformation of Items the score has a scale reaching from 0 (highly unsatisfied) to 100 (highly satisfied).|From beginning of ICU stay until death or discharge of patient, whatever came first, assessed up to 2 months|By invitation||units on a scale||Standard Deviation|Mean
690293|NCT01449734|Secondary|Patient Mortality||From beginning of ICU stay until death or discharge of patient, whatever came first, assessed up to 2 months||||||
690294|NCT01449734|Secondary|Patient Length of Stay on the ICU||From beginning of ICU stay until death or discharge of patient, whatever came first, assessed up to 2 months||||||
690295|NCT01449734|Secondary|Patient Severity of Illness||From beginning of ICU stay until death or discharge of patient, whatever came first, assessed up to 2 months||||||
690296|NCT01449721|Secondary|Number of Participants With Experiencing Complications Related to Intravascular Volume Overload|"Composite safety endpoint:
Premature termination of the protocol-directed intravenous fluid administration by the investigator or primary physician due to presumed volume overload
Administration of intravenous diuretic for acute pulmonary edema
Respiratory failure requiring ventilatory assistance (BiPAP, CPAP, or mechanical ventilation) secondary to pulmonary edema per primary care team"|12 hours following treatment initiation|||Participants|||Count of Participants
690297|NCT01449721|Secondary|In-hospital Mortality|Any occurrence of mortality while the participant is in-hospital is counted as an outcome.|In-hospital discharge or up to maximum 30 days|||Participants|||Count of Participants
690317|NCT01449513|Primary|Change in Degree of Necrosis|Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel, 0.05% as assessed by RCM(Reflectance Confocal Microscopy) in AK (actinic keratosis) skin|Baseline to Day 3|As stated in the outcome measure, the degree of necrosis will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.||percentage of change||Standard Deviation|Mean
690298|NCT01449721|Primary|Number of Participants With Worsening Organ System Dysfunction Defined by SOFA Score Increase ≥ 1|"Development of worsening organ failure defined by the Sequential Organ Failure Assessment (SOFA) score. The SOFA score defines the presence and severity of dysfunction within 6 organ systems (cardiovascular, respiratory, coagulation, liver, renal, and nervous system) with a value of 0 for assigned to normal function to a maximum value of 4 for severe dysfunction in each of the organ systems. Each component of the SOFA score is added together, ranging from 0 indicating no organ dysfunction in any of the 6 organ systems, to 24 indicating maximal organ dysfunction across all 6 organ systems.
Within this trial, the occurrence of organ failure was defined by any increase in the total SOFA score by ≥ 1 point over the first 72 hours after randomization."|72 hours|||Participants|||Count of Participants
690299|NCT01449708|Secondary|PONV Between Different Surgical Procedures (Percentage of Participants)||24 hours|analysis was conducted with all participants and NOT per arm||percentage of participants|||Number
690300|NCT01449708|Secondary|Number of Patients Requiring Antiemetic Rescue Medication (AERM)||24hours|||participants|||Number
690301|NCT01449708|Primary|PONV During the First 24 Hours After Bariatric Surgery|Postoperative Nausea and Vomiting|24 hours|||participants|||Number
690302|NCT01449682|Secondary|To Determine if There is a Change in Central Foveal Thickness (Microns on High Resolution OCT) at 48 Weeks Compared to Baseline Values for Both the PRN and Q16weeks Treatment Groups||baseline to 48 weeks|||microns||Standard Error|Mean
690303|NCT01449682|Secondary|To Determine if There is a Change in Visual Acuity (Number of ETDRS Letters) at 48 Weeks Compared to Baseline Values for Both the PRN and Q16weeks Treatment Groups||baseline to 48 weeks|||ETDRS letters||Standard Error|Mean
690304|NCT01449682|Primary|Macular Function Using Multi-focal ERG|To determine if there is a change in central amplitude responses using multifocal ERG at 48 weeks compared to baseline values for both the PRN and Q16weeks treatment groups|baseline to 48 weeks|||nV/deg2||Standard Error|Mean
690305|NCT01449682|Primary|Macular Function Using Microperimetry|To determine if there is change in mean macular sensitivity using microperimetry at 48 weeks compared to baseline for both the PRN and Q16weeks treatment groups|baseline to 48 weeks|||dB||Standard Error|Mean
690306|NCT01449539|Primary|Number of Stem Cells Collected|Total stem cells collected from all participants at one week post-study treatment|one week post-treatment|Four of eight enrolled subjects completed the study.||stem cells|||Number
690307|NCT01449526|Secondary|Slit Lamp > Grade 2|Proportion of eyes with any slit lamp findings greater than grade 2 at any visit between the Test and Control lenses.|3 months|Number of dispensed eyes with non-missing scores in each treatment group.||eyes (2 per participant)|Participants||Number
690308|NCT01449526|Primary|Visual Acuity (VA)|Mean high contrast, distance logMAR VA for each eye between the Test and Control lenses. This measure is an average from 4 visits taking place over 3 months.|4 visits over 3 months|All Eligible, Dispensed Eyes||LogMAR|Participants|Standard Deviation|Least Squares Mean
690309|NCT01449513|Primary|Change in Degree of Necrosis|Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel, 0.05% as assessed by RCM in normal skin|Baseline to Day 57|As stated in the outcome measure, the degree of necrosis will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.||percentage of change||Standard Deviation|Mean
690310|NCT01449513|Primary|Change in Degree of Necrosis|Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in Sub AK (actinic keratosis) skin|Baseline to Day 57|As stated in the outcome measure, the degree of necrosis will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.||percentage of change||Standard Deviation|Mean
690311|NCT01449513|Primary|Change in Degree of Necrosis|Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in AK (actinic keratosis) skin|Baseline to Day 57|As stated in the outcome measure, the degree of necrosis will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.||percentage of change||Standard Deviation|Mean
690312|NCT01449513|Primary|Change in Degree of Necrosis|Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel,0.05% as assessed by RCM (Reflectance Confocal Microscopy) in normal skin|Baseline to Day 8|As stated in the outcome measure, the degree of necrosis will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.||percentage of change||Standard Deviation|Mean
690313|NCT01449513|Primary|Change in Degree of Necrosis|Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in Sub AK (actinic keratosis) skin|Baseline to Day 8|As stated in the outcome measure, the degree of necrosis will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.||percentage of change||Standard Deviation|Mean
690314|NCT01449513|Primary|Change in Degree of Necrosis|Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in AK (actinic keratosis) skin|Baseline to Day 8|As stated in the outcome measure, the degree of necrosis will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.||percentage of change||Standard Deviation|Mean
690315|NCT01449513|Primary|Change in Degree of Necrosis|Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in normal skin|Baseline to Day 3|As stated in the outcome measure, the degree of necrosis will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.||percentage of change||Standard Deviation|Mean
690316|NCT01449513|Primary|Change in Degree of Necrosis|Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in Sub AK (actinic keratosis) skin|Baseline to Day 3|As stated in the outcome measure, the degree of necrosis will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.||percentage of change||Standard Deviation|Mean
695709|NCT01386632|Secondary|Health-related Quality of Life Among Study Patients by Treatment Arm.||Completion of Treatment||||||
690318|NCT01449513|Primary|Change in Degree of Necrosis|Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in normal skin|Baseline to Day 2|As stated in the outcome measure, the degree of necrosis will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.||percentage of change||Standard Deviation|Mean
690319|NCT01449513|Primary|Change in Degree of Necrosis|Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in Sub AK (actinic keratosis) skin|Baseline to Day 2|As stated in the outcome measure, the degree of necrosis will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.||percentage of change||Standard Deviation|Mean
690320|NCT01449513|Primary|Change in Degree of Necrosis|Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in AK (actinic keratosis) skin|Baseline to Day 2|As stated in the outcome measure, the degree of necrosis will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.||percentage of change||Standard Deviation|Mean
690321|NCT01449513|Primary|Change in Degree of Infiltration|"Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in normal skin
The degree of infiltration of the epidermis by inflammatory cells will be based on “inflammation/small bright cells” (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. The degree of infiltration of the dermis by inflammatory cells will be based on “inflammatory cells in the dermis” (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel."|Baseline to Day 57|As stated in the outcome measure, the degree of infiltration will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.||percentage of change||Standard Deviation|Mean
690322|NCT01449513|Primary|Change in Degree of Infiltration|"Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in Sub AK (actinic keratosis) skin
The degree of infiltration of the epidermis by inflammatory cells will be based on “inflammation/small bright cells” (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. The degree of infiltration of the dermis by inflammatory cells will be based on “inflammatory cells in the dermis” (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel."|Baseline to Day 57|As stated in the outcome measure, the degree of infiltration will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.||percentage of change||Standard Deviation|Mean
690323|NCT01449513|Primary|Change in Degree of Infiltration|"Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in AK (actinic keratosis) skin
The degree of infiltration of the epidermis by inflammatory cells will be based on “inflammation/small bright cells” (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. The degree of infiltration of the dermis by inflammatory cells will be based on “inflammatory cells in the dermis” (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel."|Baseline to Day 57|As stated in the outcome measure, the degree of infiltration will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.||percentage of change||Standard Deviation|Mean
690324|NCT01449513|Primary|Change in Degree of Infiltration|"Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in normal skin
The degree of infiltration of the epidermis by inflammatory cells will be based on “inflammation/small bright cells” (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. The degree of infiltration of the dermis by inflammatory cells will be based on “inflammatory cells in the dermis” (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel."|Baseline to Day 8|As stated in the outcome measure, the degree of infiltration will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.||percentage of change||Standard Deviation|Mean
690325|NCT01449513|Primary|Change in Degree of Infiltration|"Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in Sub AK (actinic keratosis) skin
The degree of infiltration of the epidermis by inflammatory cells will be based on “inflammation/small bright cells” (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. The degree of infiltration of the dermis by inflammatory cells will be based on “inflammatory cells in the dermis” (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel."|Baseline to Day 8|As stated in the outcome measure, the degree of infiltration will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.||percentage of change||Standard Deviation|Mean
690326|NCT01449513|Primary|Change in Degree of Infiltration|"Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in AK (actinic keratosis) skin
The degree of infiltration of the epidermis by inflammatory cells will be based on “inflammation/small bright cells” (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. The degree of infiltration of the dermis by inflammatory cells will be based on “inflammatory cells in the dermis” (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel."|Baseline to Day 8|As stated in the outcome measure, the degree of infiltration will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.||percentage of change||Standard Deviation|Mean
690427|NCT01447914|Secondary|Time to Next Treatment (TTNT)|Kaplan and Meier product limit methods will be used to estimate the TTNT with 95% confidence intervals.|From registration on trial to next treatment or death due to any cause, whichever comes first, assessed up to 30 days||||||
690327|NCT01449513|Primary|Change in Degree of Infiltration|"Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in normal skin
The degree of infiltration of the epidermis by inflammatory cells will be based on “inflammation/small bright cells” (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. The degree of infiltration of the dermis by inflammatory cells will be based on “inflammatory cells in the dermis” (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel."|Baseline to Day 3|As stated in the outcome measure, the degree of infiltration will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.||percentage of change||Standard Deviation|Mean
690328|NCT01449513|Primary|Change in Degree of Infiltration|"Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in Sub AK (actinic keratosis) skin.
The degree of infiltration of the epidermis by inflammatory cells will be based on “inflammation/small bright cells” (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. The degree of infiltration of the dermis by inflammatory cells will be based on “inflammatory cells in the dermis” (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel."|Baseline to Day 3|As stated in the outcome measure, the degree of infiltration will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.||percentage of change||Standard Deviation|Mean
690329|NCT01449513|Primary|Change in Degree of Infiltration|Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in AK (actinic keratosis) skin|Baseline to Day 3|As stated in the outcome measure, the degree of infiltration will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.||percentage of change||Standard Deviation|Mean
690330|NCT01449513|Primary|Change in Degree of Infiltration|"Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in normal skin.
The degree of infiltration of the epidermis by inflammatory cells will be based on “inflammation/small bright cells” (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. The degree of infiltration of the dermis by inflammatory cells will be based on “inflammatory cells in the dermis” (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel."|Baseline to Day 2|As stated in the outcome measure, the degree of infiltration will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.||percentage of change||Standard Deviation|Mean
690331|NCT01449513|Primary|Change in Degree of Infiltration|"Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by Reflectance Confocal Microscopy (RCM) in Sub actinic keratosis (AK) skin.
The degree of infiltration of the epidermis by inflammatory cells will be based on “inflammation/small bright cells” (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. The degree of infiltration of the dermis by inflammatory cells will be based on “inflammatory cells in the dermis” (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel."|Baseline to Day 2|As stated in the outcome measure, the degree of infiltration will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.||percentage of change||Standard Deviation|Mean
690332|NCT01449513|Primary|Change in Degree of Infiltration|"Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by Reflectance Confocal Microscopy (RCM) in actinic keratosis (AK) skin.This RCM imaging technique is a relatively new non-invasive, real-time evaluation method to generate horizontal skin sections at a resolution comparable to routine histology.
The degree of infiltration of the epidermis by inflammatory cells will be based on “inflammation/small bright cells” (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. The degree of infiltration of the dermis by inflammatory cells will be based on “inflammatory cells in the dermis” (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel."|Baseline to Day 2|As stated in the outcome measure, the degree of infiltration will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.||percentage change||Standard Deviation|Mean
690333|NCT01449461|Secondary|Intracranial Progression Free Survival (PFS)|PFS is defined as the time interval from the date of the first dose of the study treatment until the first date at which disease progression in brain, or death due to any cause, whichever occurs first. Intracranial PFS was calculated by Kaplan-Meier estimation.|Screening and at 8-week intervals thereafter up to data cut-off date: 16 November 2015 (approximately up to 50 months)|Full analysis set. ALK+ NSCLC participants with measurable and only non-measurable brain metastases at baseline were evaluated for this outcome measure.||months||95% Confidence Interval|Median
690334|NCT01449461|Secondary|Duration of Intracranial Response|Intracranial duration of response is defined as the time interval from the time that the measurement criteria are first met for CR/PR in brain metastases (whichever is first recorded) until the first date that progressive disease is objectively documented or death due to any cause. Participants who did not progress nor die were censored at the last valid response assessment. Duration intracranial of response was calculated by Kaplan-Meier estimation.|Screening and at 8-week intervals thereafter up to data cut-off date: 16 November 2015 (approximately up to 50 months)|Full analysis set. ALK+ NSCLC participants with measurable and only non-measurable brain metastases at baseline were evaluated for this outcome measure.||months||95% Confidence Interval|Median
690357|NCT01449370|Secondary|Ctrough: Observed Concentration at the End of Dosing Interval for TAK-117||Process A: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 24 hrs) post-dose; Process B: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 48 hrs) post-dose|PK population included all participants who took at least 1 dose of study drug and had sufficient concentration-time data to calculate PK parameters.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
695710|NCT01386632|Secondary|Overall Survival for Locally Advanced Head and Neck Squamous Cell Carcinoma Patients Receiving Concurrent Cisplatin, Radiation Therapy, and DCA.||5 year||||||
690335|NCT01449461|Secondary|Intracranial Objective Response Rate|Intracranial objective response rate is defined as the proportion of the participants with CR or PR in the intracranial CNS per modification of RECIST v1.1 after the initiation of study drug. CR for target lesion: disappearance of all extranodal lesions. CR for non-target lesion: disappearance of all extranodal non-target lesions and normalization of tumor marker level. PR: at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline sum diameters. Meta.=Metastases.|Screening and at 8-week intervals thereafter up to data cut-off date: 16 November 2015 (approximately up to 50 months)|Full analysis set. ALK+ NSCLC participants with measurable and only non-measurable brain metastases at baseline were evaluated for this outcome measure. Here, n is the number of participants who were evaluable for specific category.||percentage of participants||95% Confidence Interval|Number
690336|NCT01449461|Secondary|Overall Survival (OS)|OS is defined as the time interval from the date of the first dose of the study treatment until death due to any cause.|Screening and at 8-week intervals thereafter up to data cut-off date: 16 November 2015 (approximately up to 50 months)|Full analysis set. Participants with anaplastic lymphoma kinase (ALK) and non-small cell lung cancer (NSCLC) were evaluated for this outcome measure.||months||95% Confidence Interval|Median
690337|NCT01449461|Secondary|Progression Free Survival (PFS)|PFS is defined as the time interval from the date of the first dose of the study treatment until the first date at which disease progression is objectively documented, or death due to any cause, whichever occurs first. Disease progression for target lesion: SLD increased by at least 20% from the smallest value on study (including baseline, if that is the smallest) and SLD must also demonstrate an absolute increase of at least 5 mm or development of any new lesion. Disease progression for non-target lesion: Unequivocal progression of existing non-target lesions. (Subjective judgment by experienced reader). PFS was calculated by Kaplan-Meier estimation.|Screening and at 8-week intervals thereafter up to data cut-off date: 16 November 2015 (approximately up to 50 months)|Full analysis set. Participants with anaplastic lymphoma kinase (ALK) and non-small cell lung cancer (NSCLC) were evaluated for this outcome measure. Here 'n' is participants analysed for each category.||months||95% Confidence Interval|Median
690338|NCT01449461|Secondary|Duration of Response|Duration of response is defined as time interval from the time that measurement criteria are first met for CR/PR (whichever is first recorded) until first date that progressive disease is objectively documented or death due to any cause. Participants who did not progress nor die were censored at last valid response assessment. CR for target lesion: disappearance of all extranodal lesions and all pathological lymph nodes must have decreased to <10 mm in short axis. CR for non-target lesion: disappearance of all extranodal non-target lesions, all lymph nodes must be non-pathological in size (<10mm short axis) and normalization of tumor marker level. PR: at least a 30% decrease in SLD of target lesions. PD for target lesion: SLD increased by at least 20% from smallest value and must also demonstrate an absolute increase of at least 5 mm or development of any new lesion. PD for non-target lesion: unequivocal progression of existing non-target lesions.|Screening and at 8-week intervals thereafter up to data cut-off date: 16 November 2015 (approximately up to 50 months)|FAS. Participants who were responders among those who were had anaplastic lymphoma kinase (ALK) and non-small cell lung cancer (NSCLC) were evaluated for this outcome measure. Here 'n' is participants analysed for each category. Duration of response was calculated by Kaplan-Meier estimation.||months||95% Confidence Interval|Median
690339|NCT01449461|Secondary|Best Overall Response|Best overall response is defined as proportion of participants with CR, PR, stable disease (SD) or progressive disease (PD) as per of RECIST v1.1 as evaluated by investigator. CR for target lesion: disappearance of all extranodal lesions and all pathological lymph nodes must have decreased to <10 mm in short axis. CR for non-target lesion: disappearance of all extranodal non-target lesions, all lymph nodes must be non-pathological in size (<10mm short axis) and normalization of tumor marker level. PR: at least a 30% decrease in the SLD of target lesions, taking as reference the baseline sum diameters. Disease progression for target lesion: SLD increased by at least 20% from smallest value on study and SLD must also demonstrate an absolute increase of at least 5 mm or development of any new lesion. PD for non-target lesion: unequivocal progression of existing non-target lesions. SD for neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|Screening and at 8-week intervals thereafter up to data cut-off date: 16 November 2015 (approximately up to 50 months)|Full analysis set. Participants with anaplastic lymphoma kinase (ALK) and non-small cell lung cancer (NSCLC) were evaluated for this outcome measure.||percentage of participants||95% Confidence Interval|Number
690340|NCT01449461|Secondary|Terminal Phase Elimination Half-life (T1/2) for Brigatinib||Cycle 2 Day 1|Analysis was performed on all enrolled participants in the study who received at least one dose of brigatinib. Participants of brigatinib 90 mg QD-180 mg QD arm were included as per treatment received at each time point.||hours||Standard Deviation|Mean
690341|NCT01449461|Secondary|AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Post-dose for Brigatinib||Cycle 1 Day 1, 8, 15 and 22 pre-dose and Day 1 multiple timepoints (up to 48 hours) post-dose; Cycle 2 Day 1 and 3 pre-dose and Day 1 multiple time points (up to 48 hours) post-dose|Analysis was performed on all enrolled participants in the study who received at least one dose of brigatinib. Participants of brigatinib 90 mg QD-180 mg QD arm were included as per treatment received at each time point.||h*ng/mL||Standard Deviation|Mean
690342|NCT01449461|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Brigatinib||Cycle 2 Day 1|Analysis was performed on all enrolled participants in the study who received at least one dose of brigatinib.||hour||Standard Deviation|Mean
690343|NCT01449461|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Brigatinib||Cycle 1 Day 1|Analysis was performed on all enrolled participants in the study who received at least one dose of brigatinib. Participants of brigatinib 90 mg QD-180 mg QD arm were included as per treatment received at each time point.||hours||Standard Deviation|Mean
690344|NCT01449461|Secondary|Cmax: Maximum Observed Plasma Concentration for Brigatinib||Cycle 2 Day 2|Analysis was performed on all enrolled participants in the study who received at least one dose of brigatinib. Here number of participants analyzed is the participants who were evaluable for this outcome measure.||ng/mL||Standard Deviation|Mean
690345|NCT01449461|Secondary|Cmax: Maximum Observed Plasma Concentration for Brigatinib||Cycle 1 Day 1|Analysis was performed on all enrolled participants in the study who received at least one dose of brigatinib. Here number of participant analyzed is the participants who were evaluable for this outcome measure.||ng/mL||Standard Deviation|Mean
690346|NCT01449461|Secondary|Number of Participants With Dose Limiting Toxicities (DLTs) Assessed in Dose Escalation Phase of the Study|DLT include any toxicity that is possibly, probably, or definitely drug-related. Toxicity grades will be defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 4.0. DLTs are defined by the following: A) Non-hematologic toxicities: Any grade ≥3 non-hematologic toxicity, with the exception of self-limiting or medically controllable toxicities (eg, nausea, vomiting, fatigue, electrolyte disturbances, hypersensitivity reactions) lasting < 3 days, and excluding alopecia. B) Hematologic toxicities: Febrile neutropenia not related to underlying disease (fever, > 101°F; ANC<500); Prolonged grade 4 neutropenia (> 7 days); Neutropenic infection: ≥ grade 3 neutropenia with ≥ grade 3 infection; Thrombocytopenia ≥ grade 3 with bleeding or grade 4 lasting ≥ 7 days. C) Missed ≥ 25% of planned doses of brigatinib over 28 days due to treatment-related AEs in the first cycle.|Up to Cycle 1 (28 days)|Safety population included all enrolled participants who received at least one dose of study drug.||participants|||Number
690347|NCT01449461|Secondary|Maximum Tolerated Dose (MTD) Assessed in Dose Escalation Phase of the Study|The MTD is defined as the highest dose at which ≤ 1 of 6 evaluable participants experience a DLT within the first 28 days of treatment (end of cycle 1). Evaluable participants must complete at least 75% of their planned doses, unless missed doses are due to AEs. The cohort may be expanded to better define the safety profile for confirmation of the MTD. The maximum administered dose in the trial will likely exceed the MTD.|Up to Cycle 1 (28 days)|Safety population included all enrolled participants who received at least one dose of study drug. MTD was not formally determined.||mg|||Number
690348|NCT01449461|Secondary|Number of Participants Who Had at Least One Treatment-Emergent Adverse Event (TEAE)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|Any adverse event reported on or after the day of first dose of study drug (approximately up to 50 months)|Safety population included all enrolled participants who received at least one dose of study drug.||participants|||Number
690349|NCT01449461|Primary|Objective Response Rate (ORR)|ORR assessed by the investigator, is defined as the proportion of the participants with complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid tumors (RECIST) v1.1 after the initiation of study treatment. CR for target lesion: disappearance of all extranodal lesions and all pathological lymph nodes must have decreased to <10 mm in short axis. CR for non-target lesion: Disappearance of all extranodal non-target lesions, all lymph nodes must be non-pathological in size (<10mm short axis) and normalization of tumor marker level. PR: at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline sum diameters. Crzb=Crizotinib.|Screening and at 8-week intervals thereafter up to data cut-off date: 16 November 2015 (approximately up to 50 months)|Full analysis set (FAS) included all participants who received at least one dose of study drug. Participants with anaplastic lymphoma kinase (ALK) and non-small cell lung cancer (NSCLC) were evaluated for this outcome measure. Here, n is the number of participants who were evaluable for specific category.||percentage of participants||95% Confidence Interval|Number
690350|NCT01449461|Primary|Recommended Phase 2 Dose of Brigatinib|The RP2D is the maximum tolerated dose (MTD) or less. The MTD is defined as the dose range at which ≤ 1 of 6 evaluable participants experience dose limiting toxicities (DLT) within the first 28 days of treatment (end of cycle 1).|28 days|Safety population included all enrolled participants who received at least one dose of study drug.||mg||Full Range|Mean
690351|NCT01449370|Secondary|Percent Change From Baseline in Pharmacodynamic Markers|"Pharmacodynamic markers included phosphorylated ribosomal protein S6 (PS6), phosphorylated eukaryotic initiation factor 4E-binding protein 1 (P4EBP1), phosphorylated N-myc downstream regulated gene 1 (PNDRG1), phosphorylated proline-rich AKT substrate of 40 kilodaltons (PPRAS40), and phosphorylated serine/threonine protein kinase AKT (PAKT). Analysis population (n) for each skin biopsy biomarker is as follow: P4EBP1 (n=6,6,6,2,2,0,0,0,0,1,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0); PAKT and PNDRG1 (n=6,6,7,2,2,0,0,0,0,1,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0); PPRAS40 (n= 6,0,6,2,2,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0); PS6 (n=6,6,7,2,2,0,0,0,0,1,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0).n for each tumor tissue biomarkers is as follow: P4EBP1, PAKT, PNDRG1, and PS6 (n=1,1,0,0,1,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0); PPRAS40 (n= 1,0,0,0,1,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0)."|Cycle 1 Day 8|Asat population where baseline and post-baseline assessments were available. The ASat population included all enrolled participants who received at least 1 dose of TAK-117.||percent change||Standard Deviation|Mean
690352|NCT01449370|Secondary|%AUC Extrapolated: Percentage of Area Under Concentration-extrapolated||Process A: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 24 hrs) post-dose; Process B: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 48 hrs) post-dose|No data is reported since serum concentration of TAK-117 were below the limit of quantification.|||||
690353|NCT01449370|Secondary|AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-117||Process A: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 24 hrs) post-dose; Process B: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 48 hrs) post-dose|No data is reported since serum concentration of TAK-117 were below the limit of quantification.|||||
690354|NCT01449370|Secondary|AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-117||Process A: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 24 hrs) post-dose; Process B: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 48 hrs) post-dose|PK population included all participants who took at least 1 dose of study drug and had sufficient concentration-time data to calculate PK parameters.||nanogram hours per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
690355|NCT01449370|Secondary|T 1/2z: Terminal Disposition Phase Half-life for TAK-117||Process A: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 24 hrs) post-dose; Process B: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 48 hrs) post-dose|PK population included all participants who took at least 1 dose of study drug and had sufficient concentration-time data to calculate PK parameters.||hrs||Standard Deviation|Mean
690356|NCT01449370|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-117||Process A: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 24 hrs) post-dose; Process B: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 48 hrs) post-dose|PK population included all participants who took at least 1 dose of study drug and had sufficient concentration-time data to calculate PK parameters.||hr||Full Range|Median
690358|NCT01449370|Secondary|Cmax: Maximum Observed Plasma Concentration for TAK-117||Process A: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 24 hrs) post-dose; Process B: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 48 hrs) post-dose|Pharmacokinetic (PK) population included all participants who took at least 1 dose of study drug and had sufficient plasma concentration-time data to calculate PK parameters.||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
690359|NCT01449370|Secondary|Clinical Benefit Rate (CBR)|Clinical benefit rate was defined as the participants who achieved stable disease (SD) for at least 15 weeks, CR, or PR. The estimate of the CBR was calculated as crude percentage of participants whose best ORR was CR, PR or SD for at least 90 days.|Cycle 1 Day 8 up to Cycle 27 Day 1 or disease progression or death|The FAS population included participants who received at least 1 dose of TAK-117, baseline data for those analyses that required baseline data and postbaseline endpoint data subsequent to at least 1 dose of study drug.||percentage of participants||95% Confidence Interval|Number
690360|NCT01449370|Secondary|Duration of Objective Response|Duration of response was to be calculated for participants who achieved CR or PR. Duration of objective response was defined as the number of days from the start date of PR or CR (whichever response was achieved first) to the first date that PD or disease progression was objectively documented. The duration of objective response was to be right-censored for participants who achieved CR or PR and met 1 of the following conditions: Non-protocol anticancer treatment started before documentation of PD; Documented PD after more than 1 missed disease assessment visit; Alive and did not have documentation of PD before a data analysis cutoff date.|Cycle 1 Day 8 up to Cycle 27 Day 1 or disease progression or death|The duration of objective response analysis was not performed due to change in planned analysis.|||||
690361|NCT01449370|Secondary|Overall Response Rate (ORR)|The estimate of the ORR is calculated as crude percentage of participants who's best overall response is complete response (CR) or partial response (PR). Objective response (CR and PR) as determined by the participants best tumor response was assessed using response evaluation criteria in solid tumors (RECIST) version 1.1. As per RECIST version 1.1, CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 millimeter [mm]). No new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. Stable disease was defined as not qualifying for CR, PR, and progressive disease (PD).|Cycle 1 Day 8 up to Cycle 27 Day 1 or disease progression or death|The full analysis set (FAS) population included participants who received at least 1 dose of TAK-117, baseline data for those analyses that required baseline data and postbaseline endpoint data subsequent to at least 1 dose of study drug.||percentage of participants||95% Confidence Interval|Number
690362|NCT01449370|Primary|Number of Participants With Clinically Meaningful Changes in Electrocardiogram (ECG)||Baseline up to Cycle 27 Day 45|The ASat population included all enrolled participants who received at least 1 dose of TAK-117.||participants|||Number
690363|NCT01449370|Primary|Number of Participants With Clinically Meaningful Changes in Vital Signs||Baseline up to Cycle 27 day 45|The ASat population included all enrolled participants who received at least 1 dose of TAK-117.||participants|||Number
690364|NCT01449370|Primary|Number of Participants With Clinically Meaningful Changes in Laboratory Values||Baseline up to Cycle 27 Day 45|The ASat population included all enrolled participants who received at least 1 dose of TAK-117.||participants|||Number
690365|NCT01449370|Primary|Number of Participants With Highest Level of TEAEs Severity|Severity of AEs was evaluated based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0 as follow: Grade 1 (mild); Grade 2 (moderate); Grade 3 (severe); Grade 4 (life-threatening); Grade 5 (fatal).|Baseline up to Cycle 27 Day 45|The ASat population included all enrolled participants who received at least 1 dose of TAK-117.||participants|||Number
690366|NCT01449370|Primary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Death, Adverse Events (AEs) Leading to Discontinuation of Study Drug, and DLTs in Cycle 1||Baseline up to Cycle 27 Day 45|The ASat population included all enrolled participants who received at least 1 dose of TAK-117.||participants|||Number
690367|NCT01449370|Primary|Maximum Tolerated Dose (MTD) of TAK-117|MTD is highest dose level of TAK-117 at which no more than 1 out of 6 participants had a dose limiting toxicity (DLT) during first cycle. DLT was any 1 of following events occurring within first 21 days of Cycle 1 of TAK-117 administration, Grade 2: fasting hyperglycemia for >14 days. Grade 3: nausea and/or vomiting/diarrhea for >7 days; rash for >7 days; thrombocytopenia with bleeding; fasting hyperglycemia for >24 hours(hr). Grade >=3:nonhematologic toxicity considered clinically significant by investigator. Grade 4:neutropenia (absolute neutrophil count <=0.5*10^9per liter[/L]) for >7 days in absence of growth factor support; neutropenia of any duration accompanied with fever >=38.5 degree Celsius and/or systemic infection. Grade >=4:hematologic toxicity. Inability to administer at least 75% of planned doses of TAK-117 within Cycle 1 due to its related toxicity;Any clinically significant occurrence that investigators and sponsor agreed would place participants at undue safety risk.|Baseline up to Cycle 1 Day 21|The ASat population included all enrolled participants who received at least 1 dose of TAK-117.||mg|||Number
690368|NCT01449305|Other Pre-specified|Medicine Administration for Pain Relief During Study Period|Continue taking pharmacological pain relief if required for subjects was allowed during study period, and it had been recorded.|first menstrual cycle, second menstrual cycle and third menstrual cycle|It was analyzed based on the PP population.||percentage of participants|||Number
690369|NCT01449305|Primary|The Mean Change in Maximum Pain Level at Each Menstrual Cycle From Baseline|The severity of dysmenorrhea pain experienced by subjects will be evaluated on a VAS, ranging from zero (no pain) to ten (very severe pain).|baseline, first menstrual cycle, second menstrual cycle and third menstrual cycle|Subjects were asked to use the VAS scoring system to record, on a provided sheet, their experienced menstrual pain level daily during menstrual bleeding for a total of three consecutive menstrual cycles in house. Primary objective was analyzed based on the Per-protocol (PP) population.||scores||Standard Deviation|Mean
690370|NCT01449279|Secondary|Progression-free Survival (PFS)|Median time to progression-free survival (PFS) was calculated using the Kaplan-Meier algorithm|2 to 4 weeks after last ipilimumab and then every 3 months until disease progression.|All subject who did not have SAEs during treatment.||weeks||95% Confidence Interval|Median
690372|NCT01449279|Secondary|Stable Disease|Stable disease is measured from the start of the treatment until the criteria for progression are met, taking as reference the smallest measurements recorded since the treatment started, including the baseline measurements|2 to 4 weeks after last ipilimumab and then every 3 months until disease progression.|All patients who did not have SAEs during treatment and did not reach complete response or partial response.||weeks||Full Range|Median
690373|NCT01449279|Secondary|Duration of Partial Response.|Length of time between first dose of ipilimumab and a partial response according to RECIST v1.1 (see above) and immune response criteria|2 to 4 weeks after last ipilimumab and then every 3 months until disease progression.|all patients that did not have SAEs during treatment and did not have complete response.||weeks||Full Range|Median
690374|NCT01449279|Secondary|Duration of Complete Response|The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The duration of overall CR is measured from the time measurement criteria are first met for CR until the first date that progressive disease is objectively documented.|2 to 4 weeks after last ipilimumab dose then every 3 months +/- 2 weeks until progression of disease|all subjects||weeks||Full Range|Median
690375|NCT01449279|Secondary|Overall Survival|Median time to overall survival was calculated using the Kaplan-Meier algorithm.|2 to 4 weeks after last ipilimumab dose then every 3 months +/- 2 weeks until progression of disease|All subjects||weeks||Full Range|Median
690376|NCT01449279|Secondary|Response Rate|"Compare tumor response rate and duration of response at unirradiated sites in patients with Stage IV melanoma with historical controls.
Response assessed per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by physical measurement; magnetic resonance imaging (MRI); computed tomography (CT), positron emission tomography (PET)-CT; and/or X-rays:
Complete Response (CR) = Disappearance of all target lesions
Partial Response (PR) = ≥ 30% decrease in the sum of the longest diameter of target lesions
Overall Response (OR) = CR + PR"|2 to 4 weeks after last ipilimumab dose then every 3 months +/- 2 weeks until progression of disease|All subjects.||Participants|||Count of Participants
690377|NCT01449279|Primary|Safety Measurement - Percentage of Patients Experiencing Serious Adverse Events (SAEs) in the First 4 Months of Treatment.|Serious adverse events (SAEs) defined as untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the subject was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires in subject hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event (defined as a medical event(s) that may not be immediately life-threatening or result in death or hospitalization but, may jeopardize the subject or may require intervention to prevent one of the other serious outcomes listed in the definition above.)|4 months|All subjects.||Participants|||Count of Participants
690378|NCT01449266|Post-Hoc|Percent Change in Gadolinium Serum Concentration 4h After Third Hemodialysis Session, Estimated From Subjects With Concentration Data Above the Limit of Detection|The evaluation of the decrease in seric concentration of gadolinium, 4h after the third hemodialysis session of patients injected with 0.1 mmol/kg of Dotarem®. The percent change of gadolinium concentration was estimated from the concentration of gadolinium after Dotarem® injection. Only subjects with gadolinium concentration above the lower limit of detection were kept for analysis.|Dotarem® dialysability assessed 4h after third hemodialysis session which took place 4 days after Dotarem® administration|8 subjects had a gadolinium concentration <LLQ after third hemodialysis session||percent change in Gd concentration||Full Range|Geometric Mean
690379|NCT01449266|Post-Hoc|Percent Change in Gadolinium Serum Concentration 4h After Second Hemodialysis Session, Estimated From Subjects With Concentration Data Above the Limit of Detection|Evaluation of the decrease in seric concentration of gadolinium, 4h after the second hemodialysis session of patients injected with 0.1 mmol/kg of Dotarem®. The percent change of gadolinium concentration was estimated from the concentration of gadolinium after Dotarem® injection. Only subjects with gadolinium concentration above the lower limit of quantification (LLQ) were kept for analysis.|Dotarem® dialysability assessed 4h after second hemodialysis session which took place 2 days after Dotarem® administration|3 subjects had a gadolinium concentration <LLQ after the second hemodialysis session||Percent change in Gd concentration||Full Range|Geometric Mean
690380|NCT01449266|Secondary|Safety of Dotarem® in Dialysed Patients Evaluated by the Number of Patients Experiencing Adverse Events.|To evaluate the biological and clinical safety of Dotarem® by assessing vital signs, biological parameters, injection-site tolerance, through a 4-day post injection follow-up, adverse events through a 3-week post injection period and serious adverse events through a 3-month post injection period.|Safety assessed from patients inclusion until the last follow-up visit 3 months after Dotarem® administration|||participants|||Number
690381|NCT01449266|Primary|Dialysability of Dotarem® in Dialysed Patients|To evaluate the decrease in seric concentration of gadolinium, after each hemodialysis session of patients injected with 0.1 mmol/kg of Dotarem® . The percent change of gadolinium concentration is calculated by estimating the amount of serum gadolinium before and after each hemodialysis session. Calculations are performed only for subjects with concentration above the lower limit of quantification (LLQ)|Dotarem® dialysability assessed up to 4 days after Dotarem® administration|After second hemodialysis, 3 subjects had Gd concentration<LLQ and are not included in the analysis; after third hemodialysis, 8 subjects had Gd concentration<LLQ and are not included in the analysis||percent change in Gd concentration||Full Range|Geometric Mean
690382|NCT01449240|Secondary|Levels of GAG in Urine|The levels of GAG (including sulfated DS/HS oligosaccharides) in urine were determined by the Blyscan sulfated GAG assay kit. The concentration of GAG in urine was normalized to the urine creatinine value and reported as mg GAG/mmol creatinine.|Day 1|Pharmacodynamic Population: All patients for which an evaluable CSF sample was collected. Urinary GAG was not measured in 2 patients: 1 pediatric patient who provided a retrospective CSF sample only (no urine sample was collected) and 1 adult patient whose CSF sample was not considered evaluable and therefore their urinary GAG was not measured.||mg GAG/mmol Creatinine||95% Confidence Interval|Mean
690428|NCT01447914|Secondary|Duration of Response|Kaplan and Meier product limit methods will be used to estimate the DOR with 95% confidence intervals.|From first observation of partial response to the time of disease progression, assessed up to 30 days||||||
690383|NCT01449240|Primary|Levels of Total Glycosaminoglycan (GAG) in CSF|The concentration of total GAG, including heparan sulfate (HS) and dermatan sulfate (DS) oligosaccharides, in CSF was measured using an enzymatic assay.|Day 1|Pharmacodynamic Population: All patients for which an evaluable CSF sample was collected. This included a pediatric patient who was consented to provide a retrospective CSF sample.||ng/mL||95% Confidence Interval|Mean
690384|NCT01449006|Secondary|Change in MRS Cerebral Metabolite Ratios in Frontal White Matter|Change in major cerebral metabolites in the frontal white matter, as measured by 1H-Magnetic Resonance Spectroscopy (MRS), between baseline and 12-months. Spectra were acquired on a Phillips Achieva 3T MRI scanner using point-resolved spectroscopy (PRESS) sequence with short TE. jMRUI/AMARES algorithm was used to process spectra. Metabolite ratios were calculated for the following metabolites: N-acetyl aspartate (NAA), choline (Cho), creatine (Cr), myo-inositol (mIo), glutamate/glutamine complex (Glx), in relation to internal H2O as standard.|Baseline and 12 months|The analysis included all randomized participants who were included in the primary analysis aside from n=1 control who did not attend MRI appointment at 12-months.||ratio||Standard Error|Least Squares Mean
690385|NCT01449006|Secondary|Change in MRS Cerebral Metabolite Ratios in Basal Ganglia|Change in major cerebral metabolites in the basal ganglia, as measured by 1H-Magnetic Resonance Spectroscopy (MRS), between baseline and 12-months. Spectra were acquired on a Phillips Achieva 3T MRI scanner using point-resolved spectroscopy (PRESS) sequence with short echot time (TE). jMRUI/AMARES algorithm was used to process spectra. Metabolite ratios were calculated for the following metabolites: N-acetyl aspartate (NAA), choline (Cho), creatine (Cr), myo-inositol (mIo), in relation to internal water (H20) as standard.|Baseline and 12 months|The analysis included all randomized participants who were included in the primary analysis aside from n=1 control who did not attend MRI appointment at 12-months.||ratio||Standard Error|Least Squares Mean
690386|NCT01449006|Secondary|Change in CSF Neopterin Concentration|Change in concentration of the CSF neuroinflammatory marker neopterin (measured in nmol/L) from baseline to 12-months.|Baseline and 12-months|The analysis included all randomized participants who were included in the primary analysis aside from n=1 control and n=2 maraviroc who did not provide a CSF sample at 12-months.||nmol/L||Standard Error|Least Squares Mean
690387|NCT01449006|Primary|Change in Neurocognitive Functioning|Change in overall neurocognitive performance, defined as a global neurocognitive z-score, over the study time-period (baseline, 6-months, 12-months). To derive this score, 1) raw scores obtained from a 5-domain brief neurocognitive battery were converted to age-corrected z-scores (M=0, SD=1) and 2) the set of individual subtest z-scores were averaged to generate a single composite (global) z-score for each subject. Lower (negative) scores therefore indicate greater levels of cognitive impairment.|Baseline, 6-months and 12-months|Modified intent-to-treat analysis. All randomized participants were included except for n=2 controls with baseline data only (1 lost to follow-up, 1 withdrew before 6-months) and n=1 control where a protocol violation was noted (randomized without conclusive evidence of neurocognitive impairment - see participant flow section).||Global Neurocognitive Z-Score||Standard Error|Least Squares Mean
690388|NCT01448850|Secondary|Number of Participants Exhibiting Anti-Drug Antibodies for MEDI8968 at Any Visit|Anti-drug antibodies for MEDI8968 were analyzed for participants who received placebo or MEDI8968 as per planned analysis.|Day 1 up to Week 69|Immunogenicity (IM) population included all participants who were randomized, received at least one dose of investigational product, and had at least one post-dose serum sample for IM testing.||participants|||Number
690389|NCT01448850|Secondary|Observed Serum Concentrations of MEDI8968||Pre-dose (Baseline), Post-dose on Week 53|PK population included all participants who were randomized, received at least one dose of investigational product, and had at least one post-dose serum concentration.||nanogram per milliliters (ng/mL)||Standard Deviation|Mean
690390|NCT01448850|Secondary|Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between administration of study drug and up to Week 69 that were absent before treatment or that worsened relative to pre-treatment state. TEAEs reported below included both SAEs and non-serious AEs.|Day 1 up to Week 69|Safety population included all participants who were randomized and received at least one dose of investigational product.||participants|||Number
690391|NCT01448850|Secondary|Percentage of Participants With Improvement in Body Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity (BODE) Score|The BODE index is a multi-dimension COPD grading system that incorporates body-mass index (B), degree of airflow obstruction (O), dyspnea (D), and exercise capacity (E) as measured by the modified medical research council (MMRC) dyspnea scale and the 6-minute walk test. The MMRC dyspnea scale is a 5-point scale that measures the level of dyspnea (trouble breathing) experienced by participants where score range is 0 (none) to 4 (very severe). BODE score is derived into a score range of 0 (healthy) to 10 (severe COPD). Negative change score signifies improvement compared to baseline. Number of participants with improvement in BODE score compared to baseline were reported.|Baseline and Week 53|The mITT population included all participants who were randomized into the study and received any investigational product. Here, 'N' signifies those participants evaluable for this measure.||percentage of participants|||Number
690392|NCT01448850|Secondary|Change From Baseline in Body Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity (BODE) Score at Week 53|The BODE index is a multi-dimension COPD grading system that incorporates body-mass index (B), degree of airflow obstruction (O), dyspnea (D), and exercise capacity (E) as measured by the modified medical research council (MMRC) dyspnea scale and the 6-minute walk test. The MMRC dyspnea scale is a 5-point scale that measures the level of dyspnea (trouble breathing) experienced by participants where score range is 0 (none) to 4 (very severe). BODE score is derived into a score range of 0 (healthy) to 10 (severe COPD).|Baseline and Week 53|The mITT population included all participants who were randomized into the study and received any investigational product. Here, 'N' signifies those participants evaluable for this measure.||units on a scale||Standard Error|Mean
690553|NCT01445873|Secondary|Change From Baseline in Pulmonary Vascular Resistance|Difference between pre-index and follow-up value.|Baseline to Month 6|FAS; N=number of participants with pre-index and follow-up value.||Dyn/s/cm5||95% Confidence Interval|Mean
690393|NCT01448850|Secondary|Percentage of Participants With Improvement in COPD-Specific Saint George’s Respiratory Questionnaire (SGRQ-C) Total Score|The SGRQ is a health related quality of life questionnaire consisting of 40 items in three domains: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). Each question’s response has a unique empirically derived weight where lowest possible weight is zero and the highest is 100. The total score and domain score are derived from the relevant items and converted to a score of 0 to 100 with a higher score indicating poorer health status. A 4-point change in total score demonstrates a clinically meaningful change, while an 8-point change and a 12-point change are interpreted as a moderate and large change in health status, respectively.|Week 53|The mITT population included all participants who were randomized into the study and received any investigational product. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||percentage of participants|||Number
690394|NCT01448850|Secondary|Change From Baseline in COPD-Specific Saint George’s Respiratory Questionnaire (SGRQ-C) Total and Subscales Scores at Week 53|The SGRQ is a health related quality of life questionnaire consisting of 40 items in three domains: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). Each question’s response has a unique empirically derived weight where lowest possible weight is zero and the highest is 100. The total score and domain score are derived from the relevant items and converted to a score of 0 to 100 with a higher score indicating poorer health status.|Baseline and Week 53|The mITT population included all participants who were randomized into the study and received any investigational product. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||units on scale||Standard Error|Mean
690395|NCT01448850|Secondary|Time to First Moderate or Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)|Time to first worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days. The severity of an AECOPD is defined as: Mild exacerbations require treatment with an increase in usual therapy, e.g., increase use of short acting bronchodilators. Moderate exacerbations require treatment with systemic corticosteroids, and or antibiotics. Severe exacerbations require hospitalization.|Day 1 up to 393|The mITT population included all participants who were randomized into the study and received any investigational product.||days||Inter-Quartile Range|Median
690396|NCT01448850|Secondary|Mean Rate of Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)|An AECOPD is defined as worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days. Severe exacerbations require hospitalization. The AECOPD rate was analyzed using a Poisson Regression model adjusted for over dispersion with number of exacerbations as the outcome and the log of follow-up time as an offset variable, with covariates for treatment group (MEDI8986, placebo), background maintenance therapy and previous exacerbations. Mean exacerbations were presented as number of exacerbations/year.|Day 1 up to 393|The mITT population included all participants who were randomized into the study and received any investigational product.||AECOPD events/year||90% Confidence Interval|Mean
690397|NCT01448850|Primary|Mean Rate of Moderate or Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)|An AECOPD is defined as worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days. The severity of an AECOPD is defined as: Moderate exacerbations require treatment with systemic corticosteroids, and or antibiotics. Severe exacerbations require hospitalization. The AECOPD rate was analyzed using a Poisson Regression model adjusted for over dispersion with number of exacerbations as the outcome and the log of follow-up time as an offset variable, with covariates for treatment group (MEDI8986, placebo), background maintenance therapy and previous exacerbations. Mean exacerbations were presented as number of exacerbations/year.|Day 1 up to 393|Modified intent-to-treat (mITT) population included all participants who were randomized into the study and received any investigational product.||AECOPD events/year||90% Confidence Interval|Mean
690398|NCT01448707|Secondary|Number of Participants Reporting Resistance Mutations With Confirmed Virologic Failure Who Have HIV RNA >400 Copies/mL and Genotype Resistance Results|The viral genotype of participants treated with DRV/rtv monotherapy versus triple therapy containing DRV/rtv over 48 and 96 weeks. Genotypic resistance (number of resistance mutations) at any time point when a participant had a confirmed plasma VL >400 copies/mL after randomization was performed per treatment group for the ITT population. Results were summarized based on individual treatment received: Darunavir resistance mutations, non-nucleoside reverse transcriptase inhibitor (NNRTI) mutations, nucleoside reverse transcriptase inhibitor (NRTI) mutations, protease inhibitor (PI) resistance mutations, PR mutations, RT mutations, extended NNRTI mutations, primary PI mutations.|Over 48 and 96 Weeks|The intent-to-treat (ITT) population is the set of all participants who were randomized and who took at least one dose of study medication in the treatment phase.||Participants|||Number
690399|NCT01448707|Secondary|Number of Participants Reporting Treatment-Emergent Phenotypic Drug Resistance|The loss of treatment options of DRV/rtv monotherapy versus triple therapy containing DRV/rtv at Weeks 48 and 96, as defined by treatment-emergent phenotypic drug resistance. Drug resistance is classified as: 1) Confirmed HIV RNA >= 400 copies/mL, 2) Post-baseline phenotypic data and 3) Phenotypic resistance to any of the drug classes (NRTI, NNRTI, or PI).|At Weeks 48 and 96|The intent-to-treat (ITT) population is the set of all participants who were randomized and who took at least one dose of study medication in the treatment phase.||Participants|||Number
690400|NCT01448707|Secondary|Time to Loss of Virologic Response|Time (in days) it takes to show loss of response per time to loss of virologic response (TLOVR) algorithm: confirmed HIV-1 RNA >= 50 copies/mL or premature discontinuation.|Baseline up to Week 96 or early withdrawal|The intent-to-treat (ITT) population is the set of all participants who were randomized and who took at least one dose of study medication in the treatment phase.||Days||Full Range|Median
690410|NCT01448525|Primary|Percentage of Participants Who Are Satisfied or Very Satisfied With Their Eyelashes Overall|"Participants rated their overall eyelash satisfaction by answering Eyelash Satisfaction Questionnaire (ESQ-9) question #3: Overall, how satisfied are you with your eyelashes? using a 5-point scale: -2=very unsatisfied (worst), -1=unsatisfied, 0=neutral, 1=satisfied or 2=very satisfied (best). The percentage of participants who rated their satisfaction as 1=satisfied or 2=very satisfied at Week 16 is reported."|Week 16|Intent to treat population included all randomized participants who had at least 1 post-baseline efficacy assessment.||Percentage of participants|||Number
690401|NCT01448707|Secondary|Change From Baseline in Global Neurocognitive Performance z-Score|Change in neurocognitive function of DRV/rtv monotherapy versus triple therapy containing DRV/rtv over 48 and 96 weeks. Neurocognitive function will be measured by Hopkins Verbal Learning Test (verbal learning and memory), Colour Trail Test (psychomotor speed and cognitive flexibility) and Grooved Pegboard Test (psychomotor speed and fine motor function). Higher values for change in z-score represent an improvement in Neurocognitive Performance (NP).|Baseline, Week 48 and 96|The intent-to-treat (ITT) population is the set of all participants who were randomized and who took at least one dose of study medication in the treatment phase.||Units on a Scale||Standard Error|Mean
690402|NCT01448707|Secondary|Virologic Response (FDA Snapshot, Switch Included)|The percentage of participants who have plasma human immunodeficiency virus type-1 (HIV-1) ribonucleic acid (RNA) levels <50 copies/milliliters [mL] after 48 and 96 weeks of follow-up after switching to DRV/ritonavir(rtv) monotherapy versus triple therapy containing DRV/rtv. Switch included is defined as all participants who discontinued randomized medication were followed up on their subsequent treatment.|Week 48 and 96|The intent-to-treat (ITT) population is the set of all participants who were randomized and who took at least one dose of study medication in the treatment phase.||Percentage of Participants|||Number
690403|NCT01448707|Secondary|Virologic Response (Food Drug and Administration [FDA] Snapshot, Switch = Failure)|The percentage of participants who have plasma human immunodeficiency virus type-1 (HIV-1) ribonucleic acid (RNA) levels <50 copies/milliliters [mL] after 96 weeks of follow-up after switching to DRV/ritonavir(rtv) monotherapy versus triple therapy containing DRV/rtv. Switch = Failure is defined as switch in background nucleoside/nucleotide reverse transcriptase inhibitors (N[t]RTIs) not permitted by the trial protocol.|Week 96|The intent-to-treat (ITT) population is the set of all participants who were randomized and who took at least one dose of study medication in the treatment phase.||Percentage of Participants|||Number
690404|NCT01448707|Primary|Virologic Response (Food Drug and Administration [FDA] Snapshot, Switch = Failure)|The percentage of participants who have plasma human immunodeficiency virus type-1 (HIV-1) ribonucleic acid (RNA) levels <50 copies/milliliters [mL] after 48 weeks of follow-up. Switch = Failure is defined as switch in background nucleoside/nucleotide reverse transcriptase inhibitors (N[t]RTIs) not permitted by the trial protocol or plasma HIV-1 RNA assessment closest to target date of the analysis time point window (44-52 weeks) and next/confirmation of Plasma HIV-1 RNA in the analysis time point window above the threshold or discontinuation for any other reason.|Week 48|The intent-to-treat (ITT) population is the set of all participants who were randomized and who took at least one dose of study medication in the treatment phase.||Percentage of Participants|||Number
690405|NCT01448616|Secondary|Asymptomatic Shedding (Shedding on Days Without Genital Lesions)|"Within person changes in shedding on days without lesions between the lead-in (observational) phase and the study drug (treatment) phase. Each arm is evaluated separately and no inter arm comparisons are made.
We evaluated only weeks 2-5 of HSV shedding during the treatment phase in comparison with the 4 weeks of the lead-in phase. We excluded the first week of samples from the treatment phase in order to allow for physiologic run-in of the treatment."|Comparison of 4 weeks of treatment phase with 4 weeks of lead-in phase|All randomized participants are included in ITT analysis. Per protocol analysis includes persons receiving 30 or more days of study drug with >90% adherence as documented by returned product counts.||% days with asymptomatic shedding||95% Confidence Interval|Number
690406|NCT01448616|Secondary|Genital Lesion Rate|"The within person change in proportion of days with lesions between the lead-in (observational) and study drug (treatment) phase for each arm separately. No between arm comparisons were performed. We include intent to treat with all randomized participants as well as per protocol (persons receiving study drug for at least 30 days with 90% or better reported compliance per returned product counts).
We evaluated only weeks 2-5 of HSV shedding during the treatment phase in comparison with the 4 weeks of the lead-in phase. We excluded the first week of samples from the treatment phase in order to allow for physiologic run-in of the treatment."|Comparison of 4 weeks of treatment phase with 4 weeks of lead-in phase|||percentage of days with lesions (%)||95% Confidence Interval|Number
690407|NCT01448616|Secondary|Within-person Changes in Log-copy Numbers of HSV|"The within-person changes in mean log-copy numbers of HSV shed during treatment phase (oral TDF, vaginal TFV, or double placebo) compared with the lead-in (observation) phase in the same participants. Each treatment arm is analyzed separately without comparison between arms.
We evaluated only weeks 2-5 of HSV shedding during the treatment phase in comparison with the 4 weeks of the lead-in phase. We excluded the first week of samples from the treatment phase in order to allow for physiologic run-in of the treatment."|Comparison of 4 weeks of treatment phase with 4 weeks of lead-in phase|Analysis is within person changes such that the observational group contributed to analyses of those persons in each treatment randomization group||log-copy number of HSV DNA shed||95% Confidence Interval|Mean
690408|NCT01448616|Primary|HSV Shedding Rate in Those Receiving Oral TDF, Vaginal TFV, or Double Placebo|The within-person changes in rate of HSV shedding during study drug administration (treatment phase) compared with the rate of HSV shedding during lead-in observation phase in the same participants. We evaluated only weeks 2-5 of HSV shedding during the treatment phase in comparison with the 4 weeks of the lead-in phase. We excluded the first week of samples from the treatment phase in order to allow for physiologic run-in of the treatment. This is analyzed separately for each treatment arm and not compared between arms.|Comparison of 4 weeks of treatment phase with 4 weeks of lead-in phase|This includes intent to treat, ( all randomized participants) and per-protocol analyses (persons receiving 30 or more days of treatment with >90% compliance as recorded by returned product counts)||percentage of swabs positive (%)||95% Confidence Interval|Number
690409|NCT01448525|Secondary|Percentage of Participants With at Least a 1-Grade Increase in the Global Eyelash Assessment (GEA) Score|The investigator evaluated the patient's overall eyelash prominence using the 4-point GEA scale: 1=minimal (worst), 2=moderate, 3=marked or 4=very marked (best). An at least a 1-grade increase in GEA score indicated improvement.|Baseline, Week 16|Intent to treat population included all randomized participants who had at least 1 post-baseline efficacy assessment.||Percentage of participants|||Number
690411|NCT01448486|Secondary|Cerebrospinal Fluid|To determine if there is improvement in CSF neopterin concentrations with the addition of Raltegravir.|Baseline and 12 months|Study was terminated prematurely with an incomplete study dataset before any meaningful analyses of the data could be conducted. CSF was not collected at 12 months for n=1 raltegravir and n=1 control who refused lumbar puncture.||nmol/L||Standard Error|Mean
690412|NCT01448486|Primary|Neurocognitive Function|Change in overall neurocognitive performance, defined as a global neurocognitive z-score, over the study time-period (baseline, 6-months, 12-months). To derive this score, 1) raw scores obtained from a 5-domain brief neurocognitive battery were converted to age-corrected z-scores (M=0, SD=1) and 2) the set of individual subtest z-scores were averaged to generate a single composite (global) z-score for each subject. Lower (negative) scores therefore indicate greater levels of cognitive impairment.|Baseline, 6 months and 12 months|Study was terminated prematurely with an incomplete study dataset any before any meaningful statistical analysis of the data (including change over the study time-points) could be performed.||Global Neurocognitive Z-Score||Standard Error|Mean
690413|NCT01448356|Secondary|Tear Film Break up Time|After instillation of fluorescein, the participant will then be asked to open the eyes, look ahead at the observer's forehead and not blink for as long as possible. The break up time is defined as the time between the lid opening and the first appearance of any dry spot on the cornea. The participant will be requested to close his eyes for few seconds and the procedure will be repeated for the left eye.|20 minutes after the required temperature and humidity in the chamber is achieved|||seconds||95% Confidence Interval|Mean
690414|NCT01448356|Primary|Tear Evaporation Rate|The rate of tear evaporation is measured by the use of ocular thermography. For each subject,his/her ocular surface temperature will be recorded twice, one for each eye. The subject at first rests his/her chin on a chin rest, with his/her forehead lean against a metal frame (which is part of the chin rest). Then the recording starts lasting approximately 20seconds for each eye. While recording, the subject needs to look straight into the lens, but can blink naturally. After this, the recording data will be analyzed to derive the evaporation rate using a mathematical model.|20 minutes after the required temperature and humidity in the chamber is achieved|||Watt/meter^2||95% Confidence Interval|Mean
690415|NCT01448213|Secondary|Number of Eyes With Intraocular Pressure (IOP) Elevation|Absolute IOP greater than or equal to 24 mm Hg or a relative increase of 10 mm Hg over the baseline preoperative reading.|one day, two days, one week, one month, 3 months, 6 months and 12 months after DMEK|||eyes|Participants||Number
690416|NCT01448213|Primary|Number of Eyes With Immunologic Graft Rejection Episodes||Within 1 year|||eyes|Participants||Number
690417|NCT01448057|Secondary|Daily Average of the Sum of a 100 mm Visual Analog Scale for All Symptoms|Subject will assess Nasal and non Nasal symptoms using a 100 mm Visual Analog Scale for each symptom, 0=no symptoms 100= the worst possible symptoms|Day 3|In the combination product arm 11 subjects had missing assessment and 5 subject in the paracetamol arm||mm||Standard Deviation|Mean
690418|NCT01448057|Primary|Physician Global Evaluation of Effectiveness on Nasal Symptoms|"The Physician will measure the reduction of Nasal Symptoms (Nasal Congestion, Sneezing, and Rhinorrhea) on day 2.
Range from 1 to 5 where 1 is excellent and 5 is bad :
1 = excellent : 75% to 100% remission of signs and symptoms 5 = bad : exacerbation of nasal symptoms"|Day 2|In the combination product arm 8 subjects had missing assessment and 1 subject in the paracetamol arm||score on a scale||Standard Deviation|Mean
690419|NCT01448044|Secondary|Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs) and Who Died|AE was defined as any new unfavorable symptom, sign, or disease or worsening of a pre-existing condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalisation.|From Day 1 (start of study treatment) up to Follow-up Week 4|Analysis was performed on all treated participants.||participants|||Number
690420|NCT01448044|Secondary|Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) or Sustained Virologic Response at Follow-up Week 24 (SVR24) by rs12979860 Single Nucleotide Polymorphism (SNP) in the IL28B Gene|Participants categorized into three genotypes based on SNPs in the IL28B gene were assessed for SVR12 and SVR24, defined as response in which hepatitis C virus RNA levels below lower limit of quantitation or below target detected or target not detected at follow-up Week 12 and Week 24 respectively.|Post Treatment Weeks 12, 24|For SVR12; analysis was performed by backward imputation method, For SVR24: analysis was performed in Modified ITT population.||Percentage of participants|||Number
690421|NCT01448044|Secondary|Percentage of Participants With Undetectable Hepatitis C Virus (HCV) RNA Levels|Participants who achieved HCV RNA undetectable ie, 10 international units per milliliter (IU/mL). Participants in the placebo arm did not have visits beyond post treatment Week 24.|Treatment Weeks 1, 2, 4, 6, 8 and 12; Weeks 4 and 12, End of treatment (EOT), Post treatment Week 24, Post treatment Week 48|The analysis was performed in modified ITT population.||Percentage of participants||95% Confidence Interval|Number
690422|NCT01448044|Secondary|Percentage of Participants Who Achieve HCV Ribonucleic Acid (RNA) < Limit of Quantification (LLOQ)|Participants who achieved HCV RNA levels below LLOQ ie, 25 international unit per milliliter (IU/mL). Participants in the placebo arm did not have visits beyond post treatment Week 24.|Treatment Weeks 1, 2, 4, 6, 8 and 12; Weeks 4 and 12; End of treatment (EOT); Post treatment Week 24; Post treatment Week 48|The analysis was performed in modified ITT population.||Percentage of participants||95% Confidence Interval|Number
690423|NCT01448044|Primary|Percentage of Participants With 12 Week Sustained Virologic Response (SVR12)|Participants were assessed for sustained virologic response 12 weeks post treatment (SVR12) defined as hepatitis C virus (HCV) RNA levels < lower limit of quantitation (LLOQ was 25 IU/mL), target detected (TD) or target not detected (TND) at post-treatment Week 12.|Week 12 (Follow-up period)|The analysis was performed in modified Intent to treat population (ITT), defined as the proportions of participants meeting the response criteria in numerator and denominator based on all treated participants. Missing values were imputed using backward imputation technique.||Percentage of participants||95% Confidence Interval|Number
690424|NCT01447927|Secondary|Overall Adverse Event Rates|"Number of patients that experienced adverse events (grade 1 or above) as measured by NCI CTCAE (Common Terminology Criteria for Adverse Events) v. 4.0.
The data reported in the table include only the commonly occurring adverse events (3 or more events)."|Up to 30 days|||participants|||Number
690425|NCT01447927|Primary|Percent Change in Median pS6K1 Immunostaining Among Participants With Barrett Esophagus|The percent change in pS6K1 was calculated as month 3 pS6k1 values minus baseline pS6k1 values, then divide by baseline pS6k1 values and multiply by 100.|Baseline to 3 months|Participants were considered evaluable for primary endpoint if pS6K1 data were available from both the pre- and post-intervention evaluations based on the intent-to-treat principle.||percentage of change||Full Range|Median
690429|NCT01447914|Secondary|Progression-free Survival (PFS)|Kaplan and Meier product limit methods will be used to estimate the median PFS with 95% confidence intervals. Furthermore, the univariate and multivariate Cox proportional hazards regression model will be used to identify prognostic factors for PFS.|From start of the treatment to disease progression or death (regardless of cause of death), whichever comes first, assessed up to 30 days||||||
690430|NCT01447914|Primary|Toxicities of Single Agent Tivantinib: Grade 3 Nonhematologic or Grade 4 Hematologic Toxicities According to the Common Terminology Criteria for Adverse Events (CTCAE), Version 4|Toxicities with a grade 3 nonhematologic or grade 4 hematologic toxicities according to CTCAE, version 4. Grade 3 and estimated with a 95% credible interval. Summary statistics will be provided for continuous variables.|Up to 30 days||||||
690431|NCT01447914|Primary|Overall Response Rate (ORR)|ORR using International Myeloma Working Group Response Criteria, achieve at least a partial response (PR) or better: Stringent Complete Response (sCR), Complete Response (CR), Very Good Partial Response (VGPR) or Partial Response (PR): CR: Negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow; sCR: CR+Normal free light chain ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; PR: ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90%; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100mg per 24 hour; Stable Disease (SD): Not CR, VGPR, PR or progressive disease; Progressive Disease (PD):>25% from lowest value Serum and/or Urine M-component, new lesions or soft tissue plasmacytomas, or hypercalcemia.|Up to 30 days|Proportion of participants reported on an intent-to-treat basis.||participants|||Number
690432|NCT01447849|Secondary|Change in Viscoelasticity of Gastric Secretion in Controls and Patients With Chronic Constipation.|The viscoelasticity of gastric mucus(centipoises) was measured in gastric juice aspirated in basal conditions and during stimulation with pentagastrin after 1 week of therapy with lubiprostone (Active Comparator) and compared with 1 week of placebo administration (Placebo Comparator).|Measured after 1 week of lubiprostone therapy and compared to 1 week of placebo with 1 week of washout in between.|To provide 0.80 statistical power for detection of significance.||Centipoises||Standard Error|Mean
690433|NCT01447849|Primary|Change of Mucus and Mucin Secretion in Patients With Chronic Constipation and in Controls.|The rate of mucus and mucin secretion(mg/hr) will be measured in gastric juice aspirated in basal conditions and during stimulation with pentagastrin after 1 week of therapy with lubiprostone (Active Comparator) and compared with 1 week of placebo administration (Placebo Comparator).|Measured after 1 week of lubiprostone and 1 week of placebo with 1 week of washout period in between.|Number of participants was calculated to provide statistical power of 0.80 for detection of significance.||mg/hour||Standard Error|Mean
690434|NCT01447719|Other Pre-specified|Individual Reader Results (Autopsy Within 1 Year of Scan)|Reader results (number of false negatives and number of false positives) for blinded independent readers. There were a total of 28 positive and 18 negative scans based on histopathology at autopsy.|at autopsy within 12 months of florbetapir PET scan|Includes only those subjects with time from scan to autopsy less than one year.||florbetapir PET scans|||Number
690435|NCT01447719|Other Pre-specified|Individual Reader Results (All Scans With Autopsy)|Reader results (number of false negatives and number of false positives) for blinded independent readers. There were a total of 39 positive and 20 negative scans based on histopathology at autopsy.|at autopsy within 24 months of florbetapir PET scan|||florbetapir PET scans|||Number
690436|NCT01447719|Other Pre-specified|Median Sensitivity and Specificity vs. CERAD Diagnosis|Median sensitivity and specificity for 5 independent readers to detect moderate to frequent amyloid plaques (per CERAD criteria).|at autopsy within 24 months of florbetapir PET scan|||percentage of true positives/negatives||Full Range|Median
690437|NCT01447719|Secondary|Specificity Analysis in Subjects With Autopsy Within 1 Year of Scan|Specificity of florbetapir-PET scan to detect moderate to frequent amyloid plaques. Plaque density was calculated using CERAD criteria. Florbetpir-PET scans were read by five independent readers blinded to clinical information using the binary read method (amyloid positive/negative).|at autopsy within 12 months of florbetapir PET scan|18 of 46 subjects who died within 1 year of scan had no or sparse neuritic plaques at autopsy||participants|||Number
690438|NCT01447719|Secondary|Sensitivity Analysis in Subjects With Autopsy Within 1 Year of Scan|Sensitivity of florbetapir-PET scan to detect moderate to frequent amyloid plaques. Plaque density was calculated using CERAD criteria. Florbetpir-PET scans were read by five independent readers blinded to clinical information using the binary read method (amyloid positive/negative).|at autopsy within 12 months of florbetapir PET scan|28 of 46 subjects who died within 1 year of scan had moderate to frequent neuritic plaques at autopsy||participants|||Number
690439|NCT01447719|Primary|Correlation of Florbetapir-PET Image and Amyloid Plaque Density|Spearman's rank order correlation of the median visual read of the florbetapir-PET image and the amyloid plaque density assessed post-mortem by quantitative immunohistochemistry (IHC) averaged across 6 brain regions (precuneus, parietal cortex, frontal cortex, temporal cortex, posterior cingulate, anterior cingulate). Spearman's rank order correlation ranges from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation.|at autopsy within 24 months of florbetapir PET scan|||Correlation coefficient||95% Confidence Interval|Number
690440|NCT01447719|Primary|Specificity Analysis in All Autopsy Population|Specificity of florbetapir-PET scan to detect moderate to frequent amyloid plaques. Plaque density was calculated using CERAD criteria. Florbetpir-PET scans were read by five independent readers blinded to clinical information using the binary read method (amyloid positive/negative).|at autopsy within 24 months of florbetapir PET scan|20 of 59 subjects from the all autopsy population had no or sparse neuritic plaques at autopsy||participants|||Number
690441|NCT01447719|Primary|Sensitivity Analysis in All Autopsy Population|Sensitivity of florbetapir-PET scan to detect moderate to frequent amyloid plaques. Plaque density was calculated using CERAD (Consortium to Establish a Registry for AD) criteria. Florbetpir-PET scans were read by five independent readers blinded to clinical information using the binary read method (amyloid positive/negative).|at autopsy within 24 months of florbetapir PET scan|39 of 59 subjects from all autopsy population had moderate to frequent neuritic plaques at autopsy||participants|||Number
690554|NCT01445873|Secondary|Change From Baseline in Left Ventricular End Diastolic Pressure|Difference between pre-index and follow-up value.|Baseline to Month 6|Data not analyzed: no participants had pre-index and follow-up values for this outcome measure.||mm Hg||95% Confidence Interval|Mean
690442|NCT01447706|Post-Hoc|To Explore the Utility of an EGFR Family Receptor-ligand (Heregulin, HRG) as a Predictor of Response to MM-121 and /or Paclitaxel in Formalin Fixed (FFPE) Tumor Samples|Fresh tumor samples were obtained from patients prior to enrollment and formalin-fixed for analysis. Samples were analyzed using RNA-ISH for the expression of the biomarker, heregulin. Progression-free survival was assessed using RECIST v 1.1 to determine whether patients whose tumors express HRG have a lower PFS than those whose tumors do not express HRG, and to assess whether the addition of MM-121 to Paclitaxel can increase PFS in HRG-high patients.|Time from first dose to date of progression, the longest time frame of 3.9 years|Patients with available tissue for RNA-ISH analysis||months PFS||95% Confidence Interval|Median
690443|NCT01447706|Secondary|Overall Survival|To determine whether MM-121 + paclitaxel is more effective than paclitaxel alone in prolonging overall survival. This was a time-to-event analysis of time from first dose to date of death.|Time from first dose to date of death, with a median of approximately 13 months|||months||95% Confidence Interval|Median
690444|NCT01447706|Primary|Progression Free Survival|"To determine whether MM-121 + paclitaxel was more effective than paclitaxel alone in prolonging progression-free survival in advanced ovarian cancers resistant or refractory to platinum agents. PFS was a time to event measure, and progression of disease is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Progression free survival was defined as the number of months from the date of randomization to the date of death or progression. If neither death nor progression was observed during the study, PFS data was censored at the last non-progressive disease valid tumor assessment unless the patient was discontinued due to symptomatic deterioration. If this occurred, the patient was counted as having progressive disease (PD)."|Time from first dose to date of progression, the longest time frame of 3.9 years|||months||95% Confidence Interval|Median
690445|NCT01447576|Secondary|Mean Clinical Global Impression - Improvement (CGI-I) Scale Score.|The items on CGI-I scale are 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse. The score of 0 (= not assessed) was set to missing. The CGI-I is therefore a 7-point scale from 1 through 7. CGI improvement was compared to the participants condition at Baseline.|Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and 52 (LOCF)|Efficacy dataset had participants who received at least 1 dose of brexpiprazole and had a baseline and atleast 1 postbaseline efficacy evaluation for CGI-S. LOCF dataset included data recorded at a given visit in treatment phase or, if no observation was recorded at that visit, data carried forward from the previous visit in the Treatment Phase.||Units on a scale||Standard Deviation|Mean
690446|NCT01447576|Secondary|Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Scale Score.|The CGI-S is a 7-point scale from 1 through 7. The items on CGI-S scale are: 0 = not assessed, 1 = normal, not at all ill, 2 = borderline mentally ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill participants. The score 0 (= not assessed) was set to missing.|Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and 52 (last-observation-carried-forward [LOCF])|Efficacy dataset had participants who received at least 1 dose of brexpiprazole and had a baseline and at least 1 postbaseline efficacy evaluation for CGI-S. LOCF dataset included data recorded at a given visit in treatment phase or, if no observation was recorded at that visit, data carried forward from the previous visit in the Treatment Phase.||Units on a scale||Standard Deviation|Mean
690447|NCT01447576|Primary|Participants With Adverse Events (AEs).|An AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a participant while enrolled in the trial, whether or not it was considered drug-related by the physician. The severity was assessed as mild, moderate, or severe. A treament-emergent AE (TEAE) was defined as any AE that started after start of open-label brexpiprazole; or if the event was continuous from baseline and was worsening, serious, study drug-related, or resulted in death, discontinuation, interruption, or reduction of study drug.|After the Informed Consent Form (ICF) was signed, through Follow up 30 (+2) days after last visit|The primary safety dataset included all participants exposed to at least 1 dose of brexpiprazole.||Participants|||Number
690448|NCT01447511|Primary|Warfarin Clearance.|Warfarin enantiomer (S-warfarin and R-warfarin) clearance was measured in healthy volunteers genotyped for CYP2C9*1/*1, CYP2C9*1B/*1B, CYP2C9*1/*3, CYP2C9*2/*3 and CYP2C9*3/*3 to determine the magnitude of the warfarin-fluconazole (inhibition) and warfarin-rifampin (induction) drug interactions.|Over three (two for CYP2C9*1B/*1B participants) 12-16 day study periods.|Participants with the CYP2C9*1B/*1B haplotype did not participate in the fluconazole period (inhibition). One CYP2C9*1/*3 participant only completed the control period. One CYP2C9*2/*3 participant only completed the control and fluconazole (inhibition) study periods.||mL/h||Standard Deviation|Mean
690449|NCT01447446|Secondary|Percentage of Participants With Adverse Events (AE)|An AE was defined as any adverse medical event that occurred after the participant used the investigational medicinal product (IMP) or other intervention behaviors specified by the protocol in the clinical trial regardless of relationship to the study treatment.|Up to 118 weeks|Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).||percentage of participants|||Number
690450|NCT01447446|Secondary|Percentage of Participants With Concomitant Medical Condition at Baseline||Baseline|Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).||percentage of participants|||Number
690451|NCT01447446|Secondary|Percentage of Participants Who Discontinued Treatment With Direct-Acting Anti-viral (DAA)|Participants who prolonged the treatment period from 72 weeks were not reported. Participants who discontinued their treatment as planned were included. Here, number of participant analyzed is the total number of participants who received direct-acting anti-viral (DAA).|Up to 72 weeks of treatment|Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).||percentage of participants|||Number
690452|NCT01447446|Secondary|Percentage of Participants Who Discontinued Treatment With PEG-IFN and Ribavirin (RBV)|Participants who prolonged the treatment period from 72 weeks were not reported.|Up to 72 weeks of treatment|Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).||percentage of participants|||Number
690453|NCT01447446|Secondary|Percentage of Participants Treated According to Label/Summary of Product Characteristics (SPC)||Up to 118 weeks|The data for this outcome measure were not collected and analyzed because the standard of care has changed significantly since the development of the study protocol, this comparison was no longer of practical value.|||||
690454|NCT01447446|Secondary|Duration of Overall Treatment|Duration of overall treatment was defined as the time between first and last administration of any study drug, in weeks.|Up to 118 weeks|Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).||Weeks||Standard Deviation|Mean
690455|NCT01447446|Secondary|Percentage of Participants Achieving Extended (Rapid) Virological Response (eRVR)|Extended (rapid) virological response (eRVR) defined as UVR at weeks 4 and 12 for telaprevir, and as UVR at weeks 8 and 24 for boceprevir.|Up to 98 weeks|Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).||percentage of participants||95% Confidence Interval|Number
690456|NCT01447446|Secondary|Percentage of Participants With Very Rapid Virological Response, Rapid Virological Response, Complete Early Virological Response and Partial Early Virological Response (pEVR) During First 12 Weeks|Percentage of participants with very rapid virological response (VRVR) (defined as VR/UVR by study week 2), rapid virological response (RVR) (defined as VR/UVR by study week 4, but no VRVR), complete early virological response (cEVR) (defined as VR/UVR by study week 12, but no VRVR or RVR) and partial early virological response (pEVR) (defined as a 2 log10 drop of HCV RNA by study week 12, but no VRVR, RVR or cEVR) were reported.|Up to 12 weeks|The data for all of the above mentioned virological responses were not collected and was not analyzed.|||||
690457|NCT01447446|Secondary|Percentage of Participants With Sustained Virological Response (SVR) in Participants With Dose Reductions or Treatment Interruptions|SVR 12 and 24 rates for dual therapy participants are defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) 50 international unit/milliliters (IU/mL) (as measured by a commercially available HCV RNA test with lower limit of detection less than or equal to [<=] 50 IU/mL) at 12 or 24 weeks post completion of the treatment period. If a qualitative test was used, then the lower limit of detection has to be <=50 IU/mL. SVR12 and 24 rates for triple therapy participants are defined as percentage of participants with undetectable HCV RNA assessed by a test with lower limit of detection <= 50 IU/mL at 12 or 24 weeks post completion of the treatment period. Here, number of participants analyzed excluded the participants with premature withdrawal due to lack of efficacy or non-safety reasons and participants without dose reductions or interruptions during the first 99 study days.|Up to first 12 weeks of treatment|Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).||percentage of participants||95% Confidence Interval|Number
690458|NCT01447446|Secondary|Virological Breakthrough|Virological breakthrough/rebound defined as non-VR/non-UVR during the treatment period (including end of treatment) in participants with prior VR/UVR or an increase of HCV RNA by >=1 log10 during the treatment period in comparison to the lowest HCV RNA (nadir) previously measured during the treatment period in participants without VR/UVR during the treatment period. Here, Number of participants analyzed is the participants with at least 2 on-treatment HCV RNA assessments (including EoT) or 1 on-treatment HCV RNA assessment (excluding EoT) and response at EoT by backward imputation.|Up to EOT (up to 118 weeks)|Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).||percentage of participants||95% Confidence Interval|Number
690459|NCT01447446|Secondary|Virological Relapse After End of Treatment|Virological relapse defined as non-virological response (non-VR)/non-undetectable virological response (non-UVR) at the last HCV RNA assessment during the treatment-free follow-up period in participants with VR/UVR at EOT. Here, number of participants analyzed is the participants with end of treatment response (EoT-R) who also had an HCV RNA test at least 12 weeks after EoT or whose last follow-up HCV RNA test showed non-response (HCV RNA >=50 IU/mL).|Up to 24 weeks after EOT (up to 118 weeks)|Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).||percentage of participants||95% Confidence Interval|Number
690460|NCT01447446|Secondary|Virological Response at Various on Treatment Time Points and End of Treatment (EOT)|Virological response (VR) for dual therapy participants is defined as HCV RNA <50 IU/mL as assessed by a qualitative HCV RNA test with a lower limit of detection (LLD) <=50 IU/mL or as assessed by a quantitative test with a lower limit of quantification (LLQ) <=50 IU/mL for all time points concerned. Results of HCV RNA tests with LLD and LLQ >50 IU/mL were considered as non-response. VR for triple therapy participants is defined as undetectable HCV RNA assessed by a test with lower limit of detection <=50 IU/mL (UVR). Results of HCV RNA tests with an LLD >50 IU/mL were considered as non-response for triple therapy participants.|Week 4, 12 and End of treatment (EOT) (up to 96 weeks)|Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).||percentage of participants||95% Confidence Interval|Number
690461|NCT01447446|Primary|Percentage of Participants With Sustained Virological Response at 12 Weeks Post Completion of the Treatment Period (SVR12)|SVR12 rate for dual therapy participants is defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) 50 international unit/milliliters (IU/mL) (as measured by a commercially available HCV RNA test with lower limit of detection less than or equal to [<=] 50 IU/mL) at 12 weeks post completion of the treatment period. If a quantitative test was used, the lower limit of quantification had to be <=50 IU/mL. SVR12 for triple therapy participants is defined as percentage of participants with undetectable HCV RNA assessed by a test with lower limit of detection <= 50 IU/mL at 12 weeks post completion of the treatment period.|12 weeks after end of treatment (up to 118 weeks)|Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).||percentage of participants||95% Confidence Interval|Number
690462|NCT01447446|Primary|Percentage of Participants With Sustained Virological Response at 24 Weeks Post Completion of the Treatment Period (SVR24)|SVR24 rate for dual therapy participants is defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) 50 international unit/milliliters (IU/mL) (as measured by a commercially available HCV RNA test with lower limit of detection less than or equal to [<=] 50 IU/mL) at 24 weeks post completion of the treatment period. If a quantitative test was used, the lower limit of quantification had to be <=50 IU/mL. SVR24 for triple therapy participants is defined as percentage of participants with undetectable HCV RNA assessed by a test with lower limit of detection <= 50 IU/mL at 24 weeks post completion of the treatment period.|24 weeks after end of treatment (up to 118 weeks)|Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).||percentage of participants||95% Confidence Interval|Number
690463|NCT01447433|Secondary|Change in Energy Intakes||Baseline and 12 weeks|Males were excluded from final analysis for statistical reasons.||kcal/d||Standard Deviation|Mean
690464|NCT01447433|Secondary|Change in Fasting Plasma Insulin||Baseline and 12 weeks|Males were excluded from final analysis for statistical reasons.||mIU/L||Standard Deviation|Mean
690465|NCT01447433|Secondary|Change in Fasting Plasma Glucose||Baseline and 12 weeks|Males were excluded from final analysis for statistical reasons.||mmol/L||Standard Deviation|Mean
690466|NCT01447433|Secondary|Change in Lipid-lipoprotein Profile||Baseline and 12 weeks|Males were excluded from final analysis for statistical reasons.||mmol/L||Standard Deviation|Mean
690467|NCT01447433|Secondary|Change in Blood Pressure|Systolic and diastolic blood pressures were measured in the left arm at heart level of subjects seated for a minimum of 5 minutes using mercurial sphygmomanometer.|Baseline and 12 weeks|Males were excluded from final analysis for statistical reasons.||mm Hg||Standard Deviation|Mean
690468|NCT01447433|Secondary|Change in Waist, Abdominal and Hip Circumference|Waist, abdominal and hip circumference was measured using a plastic tape to the nearest 0.1 cm|Baseline and 12 weeks|Males were excluded from final analysis for statistical reasons.||cm||Standard Deviation|Mean
690469|NCT01447433|Secondary|Change in Visceral Fat Area|BIA (bioelectric impedance analysis, ZEUS9.9, JAWON) was used to determine visceral fat area.|Baseline and 12 weeks|Males were excluded from final analysis for statistical reasons.||cm^2||Standard Deviation|Median
690470|NCT01447433|Secondary|Change in Fat Percentage|BIA (bioelectric impedance analysis, ZEUS9.9, JAWON) was used to determine fat percentage.|Baseline and 12 weeks|Males were excluded from final analysis for statistical reasons.||Percentage of body weight||Standard Deviation|Mean
690471|NCT01447433|Secondary|Change in Body Fat Mass，Body Lean Mass and Visceral Fat Mass|BIA (bioelectric impedance analysis, ZEUS9.9, JAWON) was used to determine body fat mass, body lean mass, and visceral fat mass.|Baseline and 12 weeks|Males were excluded from final analysis for statistical reasons.||kg||Standard Error|Mean
690472|NCT01447433|Primary|Change in Body Weight|Weight was obtained in light clothing to the nearest 0.1kg using a digital scale 8:00am and 10:00am after an overnight fast between.|Baseline and 12 weeks|Males were excluded from final analysis for statistical reasons.||kg||Standard Deviation|Mean
690473|NCT01447420|Secondary|Number of Participants With Viral Load Reduction (HCV-RNA Levels) at Week 4 and 12|Viral load reduction at Week 4 and Week 12 relative to the Baseline (Week 0) in terms of the expression profile of IL-28b was reported. The reduction was measured according to the following ranges: < 1.0 log IU/ml; >= 1.0 and < 2.0 log IU/ml; >= 2.0 and < 3.0 log IU/ml; >= 3.0 and <4.0 log IU/ml; >= 4.0 log IU/ml. Changes in viral load are usually reported as a log change (in powers of 10). For example, a two log decrease in viral load (2 Log10) is a decrease of 10^2 or 100 times to the previously reported levels. N = number of participants, for Week 0 to Week 4 (n = 34, 68, 17) and Week 0 to Week 12 (n = 35, 69, 18) for CC, CT and TT genotypes respectively.|From Baseline (Week 0) to Week 12|The efficacy population included all enrolled participants who received at least one dose of any study medication, excluding one participant who took medication and had HCV RNA undetectable at baseline. Participants with available data at the time of evaluation were analyzed.||participants|||Number
690474|NCT01447420|Secondary|Number of Participants With Sustained Virological Response and Occurrence of Anemia During The First Month of Treatment and After the First Month of Treatment|Participants with sustained virological response (SVR) and development of anemia during the first month and after the first month of treatment according to the different expression profiles of IL-28B were reported.|Up to Week 72|The efficacy population included all enrolled participants who received at least one dose of any study medication, excluding one participant who took medication and had HCV RNA undetectable at baseline.||participants|||Number
690503|NCT01446289|Secondary|Percentages of Infants Reporting SAEs|Percentages of infants born from women who received either one injection of the study vaccine or placebo, reporting SAEs from birth until study termination are reported.|From birth until study termination|The analysis was done on the Safety Set.||Percentages of subjects|||Number
690551|NCT01445873|Secondary|Change From Baseline in Tei Index|Difference between pre-index and follow-up value. Combined myocardial performance index calculated by adding isovolumic contraction time and isovolumic relaxation time and dividing the resulting sum by ejection time.|Baseline to Month 6|FAS; N=number of participants with pre-index and ≥ 1 follow-up value.||ratio||95% Confidence Interval|Mean
690475|NCT01447420|Secondary|Number of Participants With Viral Response Rate (Rapid/Early/End of Treatment) in Relation to IL28-B Expression|Viral Response rate (rapid/early/end of treatment) in relation to IL28-B expression (measured by the rate of non-detection of HCV RNA at treatment Weeks 4, 12, 24 and after the End of Treatment (EOT, i.e. Week 48) based on the expression profile of IL-28B (CC, CT or TT) were reported. Rapid virologic response (RVR) was defined as undetectable HCV RNA at treatment Week 4. Partial early virological response (pEVR) was defined as positive HCV viral load, but with a >= 2 log10 international units (IU) per millilitre (mL) reduction at treatment Week 12 from Baseline (Week 0); Complete early virologic response (cEVR) was defined as undetectable HCV RNA at treatment Week 12; Virologic response at treatment Week 24 (VR 24) was defined as undetectable HCV RNA at treatment Week 24; Virologic response at end of treatment (EOT) was defined as undetectable HCV RNA at treatment Week 48; SVR at 24 weeks after end of treatment was defined as undetectable HCV RNA at 24 weeks after EOT.|Weeks 4, 12, 24, 48, 60 and 72|The efficacy population included all enrolled participants who received at least one dose of any study medication, excluding one participant who took medication and had HCV RNA undetectable at baseline.||participants|||Number
690476|NCT01447420|Primary|Percentage of Participants With Incidence of Anemia|Anemia is a condition marked by a deficiency of red blood cells (RBCs) or of hemoglobin (Hb) in the blood, resulting in pallor and weariness anemia (Hb < 11 gram per decilitre (g/dL) for women and Hb < 12 g/dL for men). Incidence of anemia was calculated by dividing the number of participants who experienced the event by the number of participants in the safety population.|Up to Week 72|Safety population included all enrolled participants who received at least one dose of any study medication.||Percentage of participants||95% Confidence Interval|Number
690477|NCT01447420|Primary|Percentage of Participants With Sustained Virological Response Rate in Relation to Interleukin 28B Expression|Participants with sustained virological response (SVR) rate in relation to interleukin 28B expression were reported. SVR rate is defined as the percentage of participants with undetectable HCV Ribonucleic acid (RNA), measured at least 24 weeks after the end of treatment (48 weeks) in terms of the expression profile of Interleukin 28B (IL-28B) (CC, CT or TT) in participants with genotype 1 hepatitis C virus (HCV) chronic infection. Participants with detectable HCV RNA or without measurement at the end of the follow-up period were considered as non-responders.|At Week 72|The efficacy population included all enrolled participants who received at least one dose of any study medication, excluding one participant who took medication and had HCV RNA undetectable at Baseline (Week 0).||Percentage of participants||95% Confidence Interval|Number
690478|NCT01447225|Secondary|Immunogenicity|Samples were collected to determine the presence of an immunologic reaction to MM-121 (i.e. human anti-human antibodies).|Samples were collected for all patients pre-dose on all cycles for duration of treatment, the longest of which was 88.1 weeks, and a collection was made post-infusion in any case of infusion reaction||||||Number
690479|NCT01447225|Secondary|Pharmacokinetics (AUClast)|Pharmacokinetic (PK) evaluation was performed on plasma samples obtained weekly for the first cycle of the study and then on day 1 of each additional cycle to assess pre-treatment trough concentrations of MM-121. Non-compartmental analysis (NCA) was performed to calculate standard PK parameters, including the AUClast. Serum levels of MM-121 were measured at a central lab using an enzyme-linked immunosorbent assay (ELISA). Data is presented per dose level of MM-121 (12 mg/kg, 20 mg/kg, or 40/20 mg/kg) and per study part (Part 1 or Part 2).|Collections taken at Cycle 1, Week 1 for all patients at the start of the infusion (pretreatment), at the end of the infusion, and at 2, 4, 24 and 48 hours after the start of the MM-121 infusion|||hr* ug/mL||Geometric Coefficient of Variation|Geometric Mean
690480|NCT01447225|Secondary|Pharmacokinetics|Pharmacokinetic (PK) evaluation was performed on plasma samples obtained weekly for the first cycle of the study and then on day 1 of each additional cycle to assess pre-treatment trough concentrations of MM-121. Non-compartmental analysis (NCA) was performed to calculate standard PK parameters, including the maximum observed concentration (Cmax). Serum levels of MM-121 were measured at a central lab using an enzyme-linked immunosorbent assay (ELISA). Data is presented per dose level of MM-121 (12 mg/kg, 20 mg/kg, or 40/20 mg/kg).|Collections taken at Cycle 1, Week 1 for all patients at start of the infusion (pretreatment), at the end of the infusion, and at 2, 4, 24 and 48 hours after the start of the MM-121 infusion|||ug/mL||Geometric Coefficient of Variation|Geometric Mean
690481|NCT01447225|Secondary|Objective Response Rate|To determine the number of patients reporting an objective response using RECIST v 1.1 where a Partial Response (PR) is defined as >20% decrease in tumor burden from baseline and a Complete Response (CR) is defined as complete disappearance from tumor burden from baseline. Objective Response is presented as the total # patients with PR or CR.|patients were assessed for response during their time on study, the longest of which was 88.1 weeks|||participants with objective response|||Number
690482|NCT01447225|Primary|To Characterize Dose-limiting Toxicities (DLTs) Associated With the Combination of MM-121 With Anticancer Therapies|To establish the safety of escalating doses of MM-121 administered in combination with multiple anti-cancer therapies in order to determine the recommended phase 2 dose. Dose-escalation conducted using standard 3+3 model to determine maximum tolerated dose. Reports of Dose-Limiting Toxicities (DLTs) were assessed to determine the MTD to be used for the expansion cohort. DLTs were not measured in the Expansion Cohort.|From date of first dose to 30 days after termination, the longest 88.1 weeks|||participants reporting DLTs|||Number
690483|NCT01447225|Primary|To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Anticancer Therapies: Cabazitaxel|"Using a 3+3 dose escalation model, the maximum tolerated dose of each therapy combination was determined by assessing dose-limiting toxicities in each cohort. If 3 patients were treated and passed the observation window, escalation to the next cohort was initiated. If a DLT was reported, 3-4 additional patients were enrolled and observed. If a DLT was observed in expanded cohort, this dose was considered to be the maximum tolerated dose. The maximum tolerated dose was defined at the cohort in which two dose-limiting toxicities were observed, or as the highest target dose tested in the absence of DLTs. The determined MTD was considered the Recommended Phase 2 Dose.
Dose Levels (3 week cycles) MM-121 doses tested: 20 mg/kg IV one-time loading dose then 12 mg/kg IV QW (20/12 mg/kg); 40/20 mg/kg Cabazitaxel doses tested: 20 or 25 mg/m2 Day 1 of 3"|From date of first dose to 30 days after termination, the longest 88.1 weeks|||mg/m2|||Number
690552|NCT01445873|Secondary|Change From Baseline in Cardiac Output|Difference between pre-index and follow-up value.|Baseline to Month 6|FAS; N=number of participants with pre-index and follow-up value.||L/min||95% Confidence Interval|Mean
731611|NCT00405288|Secondary|Mode of Delivery|Method of delivery for both groups: vaginal or caesarean section|at birth|||participants|||Number
690484|NCT01447225|Primary|To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Anticancer Therapies: Pemetrexed|"Using a 3+3 dose escalation model, the maximum tolerated dose of each therapy combination was determined by assessing dose-limiting toxicities in each cohort. If 3 patients were treated and passed the observation window, escalation to the next cohort was initiated. If a DLT was reported, 3-4 additional patients were enrolled and observed. If a DLT was observed in expanded cohort, this dose was considered to be the maximum tolerated dose. The maximum tolerated dose was defined at the cohort in which two dose-limiting toxicities were observed, or as the highest target dose tested in the absence of DLTs. The determined MTD was considered the Recommended Phase 2 Dose.
Dose Levels (3 week cycles) MM-121 doses tested: 20 mg/kg IV one-time loading dose then 12 mg/kg IV QW (20/12 mg/kg); 40/20 mg/kg Pemetrexed doses tested: 500 mg/m2 Day 1"|From date of first dose to 30 days after termination, the longest 88.1 weeks|||mg/m2|||Number
690485|NCT01447225|Primary|To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Anticancer Therapies: Carboplatin|"Maximum Tolerated Dose reported in Target AUC, as calculated by the Calvert Formula
Using a 3+3 dose escalation model, the maximum tolerated dose of each therapy combination was determined by assessing dose-limiting toxicities in each cohort. If 3 patients were treated and passed the observation window, escalation to the next cohort was initiated. If a DLT was reported, 3-4 additional patients were enrolled and observed. If a DLT was observed in expanded cohort, this dose was considered to be the maximum tolerated dose. The maximum tolerated dose was defined at the cohort in which two dose-limiting toxicities were observed, or as the highest target dose tested in the absence of DLTs. The determined MTD was considered the Recommended Phase 2 Dose.
Dose Levels (3 week cycles) MM-121 doses tested: 20 mg/kg IV one-time loading dose then 12 mg/kg IV QW (20/12 mg/kg); 40/20 mg/kg Carboplatin doses tested: 5 or 6 AUC Day 1"|From date of first dose to 30 days after termination, the longest 88.1 weeks|||target AUC (mg*min/mL)|||Number
690486|NCT01447225|Primary|To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Anticancer Therapies: Gemcitabine|"Using a 3+3 dose escalation model, the maximum tolerated dose of each therapy combination was determined by assessing dose-limiting toxicities in each cohort. If 3 patients were treated and passed the observation window, escalation to the next cohort was initiated. If a DLT was reported, 3-4 additional patients were enrolled and observed. If a DLT was observed in expanded cohort, this dose was considered to be the maximum tolerated dose. The maximum tolerated dose was defined at the cohort in which two dose-limiting toxicities were observed, or as the highest target dose tested in the absence of DLTs. The determined MTD was considered the Recommended Phase 2 Dose.
Dose Levels (3 week cycles) MM-121 doses tested: 20 mg/kg IV one-time loading dose then 12 mg/kg IV QW (20/12 mg/kg); 40/20 mg/kg Gemcitabine doses tested: 1000 mg/m2 Day 1 and 8"|From date of first dose to 30 days after termination, the longest 88.1 weeks|NOTE: Maximum tolerated dose is for the combination of gemcitabine and MM-121. MTD of MM-121 is provided in separate endpoint.||mg/m2|||Number
690487|NCT01447225|Primary|To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Anticancer Therapies: MM-121 Doses|"Using a 3+3 dose escalation model, the maximum tolerated dose of each therapy combination was determined by assessing dose-limiting toxicities in each cohort. If 3 patients were treated and passed the observation window, escalation to the next cohort was initiated. If a DLT was reported, 3-4 additional patients were enrolled and observed. If a DLT was observed in expanded cohort, this dose was considered to be the maximum tolerated dose. The maximum tolerated dose was defined at the cohort in which two dose-limiting toxicities were observed, or as the highest target dose tested in the absence of DLTs. The determined MTD was considered the Recommended Phase 2 Dose.
Dose Levels (3 week cycles) MM-121 doses tested: 20 mg/kg IV one-time loading dose then 12 mg/kg IV QW (20/12 mg/kg); 40/20 mg/kg Gemcitabine doses tested: 1000 mg/m2 Day 1 and 8 Pemetrexed doses tested: 500 mg/m2 Day 1 Carboplatin doses tested: 5 or 6 AUC Day 1 Cabazitaxel doses tested: 20 or 25 mg/m2 Day 1 of 3"|From date of first dose to 30 days after termination, the longest 88.1 weeks|Note: data provided below is for MM-121 doses only for the combination. Combination therapy MTDs are provided in separate endpoint measures.||mg/kg|||Number
690488|NCT01447225|Primary|To Evaluate the Safety and Tolerability of Escalating Doses of the MM-121 Anticancer Therapies|Safety and tolerability data presented in detail in the adverse events and serious adverse events section of the results posting|From date of first dose to 30 days after termination, the longest 88.1 weeks|||participants reporting adverse events|||Number
690489|NCT01447121|Secondary|Number of Study Staff Results Within +/- 15mg/dL (<75 mg/dL) or Within +/- 20% (>=75 mg/dL) of Laboratory Glucose Method When Testing Subject Blood Glucose (BG)|Study staff tested subject fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS), which included an investigational meter and sensor. BGM results were compared with capillary plasma BG results obtained with a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG meter results were used to calculate the number of BG results within +/- 15mg/dL (for reference BG results <75mg/dL) or +/- 20% (for reference BG results >=75mg/dL) of the reference method results.|1 hour|115 (115x1) test results are possible. Staff tested blood from 118 subjects (one of 3 test strip lots). All study results from 2 subjects were excluded from data analyses as already described. Also, one test exceeded time interval (defined in protocol) between meter test and reference method.||BG test results|||Number
690490|NCT01447121|Primary|Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15mg/dL (<75 mg/dL) or Within +/- 20% (>=75 mg/dL) of Laboratory Glucose Method|Untrained subjects with diabetes tested self-test fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS), which included an investigational meter and sensor. BGM results were compared with capillary plasm BG results obtained with a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG meter results were used to calculate the number of BG results within +/- 15 mg/dL (for reference BG results <75mg/dL) or +/- 20% (for reference BG results >=75mg/dL) of the reference method results (YSI capillary plasma).|1 hour|115(115x1)test results are possible. 118 subjects tested one of 3 test strip lots on the BGM system. Study results from 2 subjects were excluded from all data analyses as already described. One subject test exceeded time interval (defined in protocol) between meter test and reference method.||BG test results|Participants||Number
690504|NCT01446289|Secondary|Percentage of Maternal Subjects Reporting Unsolicited AEs and Serious Adverse Events (SAEs)|Percentage of maternal subjects reporting unsolicited AEs, SAEs, AEs requiring a non-routine physician’s visit, AEs leading to withdrawal are reported.|All AEs were recorded until delivery, after delivery all AEs requiring a non-routine physician’s visit and AEs leading to withdrawal from the study. SAEs were collected for the duration of the trial.|The analysis was done on the Safety Set.||Percentages of subjects|||Number
690491|NCT01447017|Primary|Adverse Events (AEs)|"AEs were collected by a non-leading question such as have you experienced any new health problems or worsening of existing conditions as well as reporting events directly observed or spontaneously volunteered by patients. All AEs including but not limited to events reported by the patient, or reported in answer to an open question by the Investigator or member of the study team were recorded as an AE including the following information: Diagnosis; Start date (and time, if relevant), Stop date (and time, if relevant) or resolution; Severity; Action taken; Causality; Seriousness; Outcome."|"AEs occurring during the treatment period were collected on day 8 or 11, as applicable. Four weeks after the last dose of investigational medicinal product (IMP), previously reported AEs were followed up and assessed as recovered or not recovered."|All safety analyses were performed on safety analysis set. All randomised patients who received at least 1 dose of the IMP and had at least 1 safety follow-up performed were included in the safety analysis set.||participants|||Number
690492|NCT01446796|Secondary|Functional Capacity and Symptoms|To determine whether continuous RV pacing improves functional capacity and symptoms as measured by six minute walk test and symptoms questionnaires in the early post-LVAD implantation period.|14 days|Study terminated early due to low accrual. No data analysis completed.|||||
690493|NCT01446796|Secondary|Right Ventricular Function|To determine whether continuous RV pacing improves invasive and non-invasive measures of RV function in the early period post-LVAD implantation. Measured by Pulmonary Artery catheter measures of intra-cardiac pressures and cardiac output in the ICU setting and by qualitative and quantitative Echocardiographic measures of RV function during the hospital course.|14 days|Study terminated early due to low accrual. No data analysis completed.|||||
690494|NCT01446796|Secondary|Post-operative Need for Hemodynamic / Respiratory Support|To determine whether continuous RV pacing reduces the need for inotropic / vasoactive agents, mechanical ventilation, or other circulatory support in the early post-operative period. Measured by the number of hemodynamic and respiratory support interventions and duration of those interventions.|14 days|Study terminated early due to low accrual. No data analysis completed.|||||
690495|NCT01446796|Primary|Length of Hospitalization|To determine whether continuous RV pacing reduces ICU length of stay (number of days) and overall hospital length of stay (number of days) post-LVAD implantation.|14 days|Study terminated early|||||
690496|NCT01446705|Secondary|Health Care Quality: Care Sensitive Admissions|This study will use the Agency for Healthcare Research and Quality's (AHRQ) Prevention Quality Indicators (PQI) to calculate the outcome measure. The PQIs are a set of measures used with hospital inpatient data to identify ambulatory care sensitive conditions. The PQIs consist of 14 conditions. The study will adopt 12 that are commonly used for adult patients: angina, asthma, bacterial pneumonia, chronic obstructive pulmonary disease, congestive heart failure, dehydration, diabetes long-term complications, diabetes short-term complications, diabetes uncontrolled, hypertension, lower-limb amputation among diabetes patients, and urinary infection.|3 years||12/2016||||
690497|NCT01446705|Primary|Health Care Quality: Ambulatory Care Performance Measures|This study will measure the impact of HIE upon health care quality the underuse of ambulatory care services. Measurements of underuse before and after implementation will detect improvements in the quality of care. To measure underuse, the study employs a measurement set that is sensitive to the potential effects and feasible for electronic data capture. 15 measures have been chosen, falling in the areas of prevention, diabetes, asthma, cardiovascular disease, congestive heart failure, mental health and osteoporosis.|3 years||12/2016||||
690498|NCT01446705|Primary|Effect of Health Information Exchange on Cost|Before after analysis of the presence of health information exchange on costs within the VA healthcare system; Measure is cost, unadjusted, in dollars for the year post enrollment in the health information exchange|2 Years|5269 individuals were excluded due to lacking cost information.||$ per year unadjusted total VA cost||Standard Deviation|Median
690499|NCT01446705|Primary|Understanding Utilization of Healthcare Procedures by Veterans According to Source of Data|Determining rates of usage of healthcare by veterans by source of data. This will clue us into any differences in utilization patterns between groups.|2 years|Veterans divided into enrolled and non-enrolled in HIE groups||participants|||Number
690500|NCT01446419|Secondary|Change in ODI From Baseline to 6 Months Post-treatment|"The improvement in ODI at 6 months compared to baseline.
ODI is a patient questionnaire that assesses back dysfunction due to back pain. There are 10 questions that are scored from 0-5. The obtained score is multiplied by 2 to produce a percentage score that is reported on a scale of 0-100. Scores are interpreted as follows: 0-20% minimum disability; 21-40% moderate disability; 41-60% severe disability; 61-80% crippled; 81-100% bed bound or exaggerating their symptoms."|6 months|Per Protocol Population: subjects that received the intended therapy per randomization assignment (appropriate ablation of the basivertebral nerve in the Intracept System arm) and completed follow-up per the study protocol.||units on a scale||95% Confidence Interval|Least Squares Mean
690501|NCT01446419|Secondary|Patient Success at 3 Months|"Proportion of subjects with clinical success at 3 months, where clinical success was defined as:
3 month ODI score represented at least a 15-point reduction from baseline
no device or procedure related SAE between baseline and 3 mos.
no increase in opioid use between procedure and 3 mos.
no deficit in a motor or dermatomal sensory group at the treated level at 3 mos.
no operative interventions or invasive procedures for lumbar back pain by a pain management or spinal specialist between procedure and 3 mos."|3 months|Per Protocol Population: subjects that received the intended therapy per randomization assignment (appropriate ablation of the basivertebral nerve in the Intracept System arm) and completed follow-up per the study protocol.||percentage of patients|||Number
690502|NCT01446419|Primary|Change in ODI From Baseline to 3 Months Post-treatment|"The primary variable is the Oswestry Disability Index (ODI) and the primary efficacy endpoint is the mean improvement from baseline to 3 months in the ODI. The primary endpoint will be evaluated in both the treatment and sham groups with between-group comparisons used to assess the success of the Intracept System in reducing chronic axial low back pain.
ODI is a patient questionnaire that assesses back dysfunction due to back pain. There are 10 questions that are scored from 0-5. The obtained score is multiplied by 2 to produce a percentage score that is reported on a scale of 0-100. Scores are interpreted as follows: 0-20% minimum disability; 21-40% moderate disability; 41-60% severe disability; 61-80% crippled; 81-100% bed bound or exaggerating their symptoms."|3 months|Per Protocol Population: subjects that received the intended therapy per randomization assignment (appropriate ablation of the basivertebral nerve in the Intracept System arm) and completed follow-up per the study protocol.||units on a scale||95% Confidence Interval|Least Squares Mean
690505|NCT01446289|Secondary|Percentage of Maternal Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)|Percentage of maternal subjects reporting solicited local and systemic AEs and other indicators of reactogenicity from day 1 to 7 after vaccination are reported.|From day 1 to 7 after vaccination|The analysis was done on the Safety Set, ie, all subjects in the enrolled population who received a study vaccination, provided post vaccination safety data, provided post-baseline safety data.||Percentages of subjects|||Number
690506|NCT01446289|Secondary|Percentages of Infant Subjects Showing Anti-diphtheria Antibodies GMCs (ELISA) Over 0.1 IU/mL at 1 Month After the Last Routine Infant Immunization|Percentages of infant subjects showing anti-diphtheria antibodies GMCs (ELISA) over 0.1 IU/mL in sera collected at 1 month after the last routine infant immunization (ie, either 5 months or 7 months after birth, depending on the vaccination schedule) are reported.|1 month after the last routine infant immunization|The analysis was done on the Immunogenicity PPS.||Percentages of subjects||95% Confidence Interval|Number
690507|NCT01446289|Secondary|GMRs of Anti-GBS CPS Antibody GMCs (ELISA) in Infants at 3 Months of Age Versus GMCs at Birth|GMRs of anti-GBS CPS antibody GMCs (ELISA) against serotypes Ia, Ib and III in infants at 3 months of age (day 91 after birth) versus GMCs at birth are reported.|Day 91 after birth|The analysis was done on the Immunogenicity PPS.||Ratio||95% Confidence Interval|Geometric Mean
690508|NCT01446289|Secondary|GMC (ELISA) of Anti-GBS CPS Antibodies in Infants|GMC (ELISA) of anti-GBS CPS antibodies against serotypes Ia, Ib and III in infants at birth and at 3 months of age are reported.|Day of birth and day 91 after birth|The analysis was done on the Immunogenicity PPS.||μg/mL||95% Confidence Interval|Geometric Mean
690509|NCT01446289|Secondary|Geometric Mean Ratios (GMRs) of Antibody GMCs (ELISA) in Maternal Subjects|GMRs of GMCs (ELISA) of anti-GBS CPS antibodies against serotypes Ia, Ib and III, in maternal subjects at study day 31, at delivery and at day 91 post-partum versus day 1 (baseline) after one administration of GBS vaccine or placebo are reported.|Day 31, day of delivery, day 91 post-delivery|The analysis was done on the Immunogenicity PPS.||Ratio|Participants|95% Confidence Interval|Geometric Mean
690510|NCT01446289|Secondary|GMCs (Enzyme-linked Immunosorbent Assay, ELISA) Antibodies Against Serotypes Ia, Ib and III in Maternal Subjects|GMCs (ELISA) of anti-GBS CPS antibodies against serotypes Ia, Ib and III in maternal subjects at study day 1, study day 31 and at day 91 post-partum after one administration of GBS vaccine or placebo are reported.|Day 1, day 31 and day 91 post-delivery|The analysis was done on the Immunogenicity PPS.||µg/mL||95% Confidence Interval|Geometric Mean
690511|NCT01446289|Primary|Geometric Mean of the Ratios Between Infant Antibody Level (μg/mL) and Maternal Antibody Level (μg/mL) at Time of Delivery|The Geometric mean transfer ratio of anti-GBS CPS antibodies against serotypes Ia, Ib and III at delivery is calculated as the geometric mean of the pairwise ratios between the antibody concentrations from infant at birth and to maternal serum concentration at delivery.|Day of delivery/birth|The analysis was done on the Immunogenicity PPS.||Ratio||95% Confidence Interval|Geometric Mean
690512|NCT01446289|Primary|Geometric Mean Concentrations (GMCs) of Antibodies in Mothers and Infants at Delivery/Birth|GMCs of anti-Group B Streptococcus (GBS) capsular polysaccharide (CPS) antibodies against serotypes Ia, Ib and III in mothers and in infants at delivery/birth are presented.|Day of delivery/birth|The analysis was done on the Immunogenicity Per Protocol Set (PPS), ie: all subjects in the enrolled population who correctly received the vaccine, provided evaluable serum samples at the relevant time points and had no major protocol violation as defined prior to un-blinding.||µg/mL||95% Confidence Interval|Geometric Mean
690513|NCT01446250|Secondary|Percentage of Participants Who Achieved Sustained Virologic Response (SVR) 24 Weeks After the End of Treatment (SVR24)|SVR24 was defined as hepatitis C virus (HCV) RNA undetectable (by limit of detection) 24 weeks after end of treatment.|24 weeks post-treatment|No data has been reported because planned data analyses were not performed as the study was terminated before the outcome measure time point.|||||
690514|NCT01446250|Secondary|Percentage of Participants With Emergence of Resistant Mutations||within 48 weeks|No data has been reported because planned data analyses were not performed as the study was terminated before the outcome measure time point.|||||
690515|NCT01446250|Primary|Percentage of Participants That Discontinued Study Drug or Required Dose Reduction or Dose Interruption Due to Treatment-emergent Adverse Events||within 48 weeks|No data has been reported because planned data analyses were not performed as the study was terminated before the outcome measure time point.|||||
690516|NCT01446237|Secondary|Mean Change in ISGA From Baseline to Each Study Visit|The investigator assessed efficacy at Baseline (Day 1), Week 1, 2, 4, 8 and 12 by ISGA scale: 0- Clear (clear skin with IL or NIL), 1- Almost clear (Rare NIL with no more than rare papules), 2- Mild (greater than Grade 1, some NIL with no more than a few IL (papules/pustules only, no nodular lesions), 3- Moderate (greater than Grade 2, up to many NIL and may have some IL, but no more than one small nodular lesion), 4- Severe (greater than Grade 3, up to many NIL and IL, but no more than a few nodular lesions) and 5- Very severe (Many NIL and IL and more than a few nodular lesions. May have cystic lesions). Baseline was defined at Day 1. Change from Baseline is value at indicated time point minus the Baseline value.|Baseline (Day 1) and Week 1, 2, 4, 8, 12|ITT population. Only those participants with data available at the indicated time points were analyzed.||Scores on a scale||Standard Deviation|Mean
690517|NCT01446237|Secondary|Absolute Change in IL, NIL, and TL Count From Baseline to Each Study Visit|The investigator assessed efficacy at Baseline (Day 1), Week 1, 2, 4, 8 and 12 by lesion counts- IL (papules and pustules), NIL (open and closed comedones), and TL. The area considered for efficacy assessments was confined to the face. The area of the face to be examined extends from the hairline to the mandible; includes the forehead, cheeks, and chin; and excludes the mouth, nasal region, periocular area, and superior and inferior eyelids. Baseline was defined at Day 1. Change from Baseline is value at indicated time point minus the Baseline value.|Baseline (Day 1) and Week 1, 2, 4, 8, 12|ITT population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in category titles).||Lesions||Standard Deviation|Mean
690549|NCT01445873|Secondary|Change From Baseline in the Total Distance Walked During 6 Minute Walk Test (6MWT)|6MWT was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. Continuous pulse oximetry was conducted during the test for safety. Difference between pre-index and follow-up value.|Baseline to Month 6|FAS; N=number of participants with pre-index and 1 value recorded during follow-up period.||meters||95% Confidence Interval|Mean
690518|NCT01446237|Primary|Number of Participants With ISGA Score of 0 (Clear) or 1 (Almost Clear) at Each Study Visit|The investigator assessed efficacy at baseline (Day 1), Week 1, 2, 4, 8 and 12 by ISGA scale: 0- Clear (clear skin with IL or NIL), 1- Almost clear (Rare NIL with no more than rare papules), 2- Mild (greater than Grade 1, some NIL with no more than a few IL (papules/pustules only, no nodular lesions), 3- Moderate (greater than Grade 2, up to many NIL and may have some IL, but no more than one small nodular lesion), 4- Severe (greater than Grade 3, up to many NIL and IL, but no more than a few nodular lesions) and 5- Very severe (Many NIL and IL and more than a few nodular lesions. May have cystic lesions).|Week 1, 2, 4, 8 and 12|ITT population.||Participants|||Number
690519|NCT01446237|Primary|Number of Participants With a Minimum 2-grade Improvement of Investigator’s Static Global Assessment (ISGA) From Baseline to Each Study Visit|The investigator assessed efficacy at Baseline (Day 1), Week 1, 2, 4, 8 and 12 by ISGA scale: 0- Clear (clear skin with IL or NIL), 1- Almost clear (Rare NIL with no more than rare papules), 2- Mild (greater than Grade 1, some NIL with no more than a few IL (papules/pustules only, no nodular lesions), 3- Moderate (greater than Grade 2, up to many NIL and may have some IL, but no more than one small nodular lesion), 4- Severe (greater than Grade 3, up to many NIL and IL, but no more than a few nodular lesions) and 5- Very severe (Many NIL and IL and more than a few nodular lesions. May have cystic lesions). Baseline was defined at Day 1. Change from Baseline is value at indicated time point minus the Baseline value.|Baseline (Day 1) and Week 1, 2, 4, 8, 12|ITT population. Only those participants with data available at that particular time points were analyzed.||Participants|||Number
690520|NCT01446237|Primary|Mean Percent Changes in Inflammatory (IL), Non-inflammatory (NIL), and Total Lesion (TL) Counts From Baseline to Each Study Visit|The investigator assessed efficacy at Baseline (Day 1), Week 1, 2, 4, 8 and 12 by lesion counts- IL (papules and pustules), NIL (open and closed comedones), and TL. The area considered for efficacy assessments was confined to the face. The area of the face to be examined extended from the hairline to the mandible; includes the forehead, cheeks, and chin; and excludes the mouth, nasal region, periocular area, and superior and inferior eyelids. Baseline was defined at Day 1. Change from Baseline is value at indicated time point minus the Baseline value. Mean percent change from baseline at each study visit was presented.|Baseline (Day 1) and Week 1, 2, 4, 8, 12|Intent-to-treat (ITT) population consisted of all participants that were enrolled in the study. Only those participants with data available at the indicated time points were analyzed.||Percent change in lesions||Standard Deviation|Mean
690521|NCT01446003|Primary|Number of Participants Who Discontinued the Study Medication Due to an AE|An AE is defined as any unfavorable and unintended medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 70 days|The safety population consisted of all participants who received at least one dose of the investigational drug.||Participant|||Number
690522|NCT01446003|Primary|Number of Participants Who Experienced at Least One Adverse Event (AE)|An AE is defined as any unfavorable and unintended medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 70 days|The safety population consisted of all participants who received at least one dose of the investigational drug.||Participant|||Number
690523|NCT01446003|Secondary|Trough Plasma Concentration (Ctrough) of MK-8457|The lowest plasma concentration reached by the drug prior to the next administration was determined for Day 1 (after initial dosing) and Day 10 (after multiple dosing). The placebo group was not included; this endpoint evaluated only the MK-8457 group.|pre-AM dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post AM dose on Days 1 and 10; pre-AM dose on Day 5 or 6|The per-protocol population consisting of participants who comply with the protocol sufficiently to ensure that data were likely to exhibit the effects of treatment according to the underlying scientific model used for analysis (Ctrough).||nM||Geometric Coefficient of Variation|Geometric Mean
690524|NCT01446003|Secondary|Time to Maximum Concentration (Tmax) of MK-8457|Tmax was determined for the AM dose on Day 1 and Day 10. The placebo group was not included; this endpoint evaluated only the MK-8457 group.|pre-AM dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post AM dose on Days 1 and 10; 24 hrs post-AM dose on Day 10|The per-protocol population consisting of participants who comply with the protocol sufficiently to ensure that data were likely to exhibit the effects of treatment according to the underlying scientific model used for analysis (Tmax).||hr||Full Range|Median
690525|NCT01446003|Secondary|Maximum Concentration (Cmax) of MK-8457|Maximum plasma concentrations of MK-8521 were determined for the AM dose on Day 1 and Day 10. The placebo group was not included; this endpoint evaluated only the MK-8457 group.|pre-AM dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post AM dose on Days 1 and 10; 24 hrs post-AM dose on Day 10|The per-protocol population consisting of participants who comply with the protocol sufficiently to ensure that data were likely to exhibit the effects of treatment according to the underlying scientific model used for analysis (Cmax).||nM||Geometric Coefficient of Variation|Geometric Mean
690526|NCT01446003|Secondary|Area Under the Plasma Concentration-time Curve From Time 0 to 12 Hours (AUC0-12hr) of MK-8457|AUC0-12hr is an estimate of total plasma exposure to study drug over the dosing interval (12hr). Plasma concentrations of MK-8457 were determined on Day 1 (after initial dosing) and Day 10 (after multiple dosing). The placebo group is not included; this endpoint evaluated only the MK-8457 group.|pre-AM dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post AM dose on Days 1 and 10|The per-protocol population consisting of participants who comply with the protocol sufficiently to ensure that data were likely to exhibit the effects of treatment according to the underlying scientific model used for analysis (AUC0-12hr).||nM*hr||Geometric Coefficient of Variation|Geometric Mean
690527|NCT01446003|Secondary|Change From Baseline to Day 10 in Maximum Moving Average (maxMAΔ) Blood Pressure Measured Over 4 Hours|The effect of drug on resting blood pressure was estimated using maxMAΔ. The maxMAΔ in blood pressure was calculated as the maximum moving average change from baseline to Day 10 of 3 consecutive 15-minute blood pressure measurements across the first 4 hours after the morning (AM) and evening (PM) doses. In this method, the LS means of three consecutive time points over the 4 hour period were determined and the maximum LS mean was used for the endpoint. Blood pressure was determined using continuous monitoring at rest. Increased values represent an increase in hypertensive severity.|Up to 4 hours postdose on Days 1 and 10|The per-protocol population consisting of participants who comply with the protocol sufficiently to ensure that data were likely to exhibit the effects of treatment according to the underlying scientific model used for analysis (maxMAΔ in blood pressure).||mmHg||95% Confidence Interval|Least Squares Mean
690528|NCT01446003|Secondary|Change From Baseline to Day 10 in 24-hour Mean Ambulatory Diastolic Blood Pressure (DBP)|DBP was measured using ambulatory blood pressure monitoring (ABPM) on Day -1 and Day 10 of each treatment period. The 24-hour LS mean ambulatory DBP change from baseline was then determined for Day 10, the last day of multiple dose treatment. Baseline is defined as the average 24-hour DBP for each participant on Day -1. Increased values represent an increase in hypertensive severity.|Baseline and Day 10|The per-protocol population consisting of participants who comply with the protocol sufficiently to ensure that data were likely to exhibit the effects of treatment according to the underlying scientific model used for analysis (change in 24-hour mean ambulatory DBP).||mmHg||95% Confidence Interval|Least Squares Mean
690529|NCT01446003|Primary|Change From Baseline to Day 10 in 24-hour Mean Ambulatory Systolic Blood Pressure (SBP)|SBP was measured using ambulatory blood pressure monitoring (ABPM) on Day -1 and Day 10 of each treatment period. The 24-hour least squares (LS) mean ambulatory SBP change from baseline was then determined for Day 10, the last day of multiple dose treatment. Baseline is defined as the average 24-hour SBP for each participant on Day -1. Increased values represent an increase in hypertensive severity.|Baseline and Day 10|The per-protocol population consisting of participants who comply with the protocol sufficiently to ensure that data were likely to exhibit the effects of treatment according to the underlying scientific model used for analysis (change in 24-hour mean ambulatory SBP).||mmHg||95% Confidence Interval|Least Squares Mean
690530|NCT01445951|Secondary|Proportion of Responders Achieving HbA1c <= 7.0%|Efficacy as measured in proportion of subjects achieving HbA1c < or = to 7.0%|Week 24|Full analysis set||percentage of participants|||Number
690531|NCT01445951|Other Pre-specified|Severe Hypoglycemia Event Rate|Number of Severe Hypoglycemic Events/Total Subject Exposure Time (in months)|Baseline to Week 24|Safety population||Events/Subject-Month|||Number
690532|NCT01445951|Other Pre-specified|Total Hypoglycemia Event Rate|Number of Hypoglycemic Events/Total Subject Exposure Time (in months)|Baseline to Week 24|Safety population||Events/Subject-Month|||Number
690533|NCT01445951|Other Pre-specified|Incidence of Severe Hypoglycemia|Severe Hypoglycemia defined as: Requiring 3rd party assistance.|Baseline to Week 24|Safety population||percentage of participants|||Number
690534|NCT01445951|Other Pre-specified|Incidence of Total Hypoglycemia|Hypoglycemia, defined as blood glucose <= 70 mg/dL or in absence of blood glucose, symptoms that are resolved by the administration of carbohydrates.|Baseline to Week 24|Safety population||percentage of participants|||Number
690535|NCT01445951|Secondary|Change in Body Weight From Baseline to Week 24|Change in body weight from Baseline to Week 24|Baseline to Week 24|Full analysis set (subjects with data available at Baseline and at Week 24)||kg||Standard Error|Least Squares Mean
690536|NCT01445951|Secondary|Mean 7-point Glucose Week 24 Values||Week 24|Full analysis set||mg/dL||Standard Deviation|Mean
690537|NCT01445951|Secondary|Mean 7-point Glucose Baseline Values|Mean 7-point glucose at baseline|Baseline|Full analysis set||mg/dL||Standard Deviation|Mean
690538|NCT01445951|Secondary|FPG Change From Baseline to Week 24|Comparison of mean change from Baseline to Week 24 visit in fasting plasma glucose (FPG) levels (central laboratory results)|Baseline to Week 24|Full analysis set||mg/dL||Standard Error|Least Squares Mean
690539|NCT01445951|Secondary|FEV1 Change From Baseline to Week 24|Forced Expiratory Volume in 1 second - change from baseline to week 24|Baseline to Week 24|Safety population||Liters||Standard Error|Least Squares Mean
690540|NCT01445951|Primary|Change From Baseline to Week 24 in HbA1c|Effect of treatment as measured by change from baseline in glycated hemoglobin (HbA1c). Primary treatment difference is TI-Gen2 vs. Insulin Aspart at Week 24|Baseline to Week 24|Full analysis set||Percent of hemoglobin||Standard Error|Least Squares Mean
690541|NCT01445873|Secondary|Other Pulmonary Arterial Hypertension (PAH)-Related Outcomes: Atrial Septostomy|Number of participants who received an atrial septostomy (balloon or blade) during hospitalization.|Day 1 to Month 6|FAS; N=number of participants with hospitalizations during follow-up period.||participants|||Number
690542|NCT01445873|Secondary|Other Pulmonary Arterial Hypertension (PAH)-Related Outcomes: Heart/Lung Transplantation|Number of participants who received an heart/lung transplant during hospitalization.|Day 1 to Month 6|FAS; N=number of participants with hospitalizations during follow-up period.||participants|||Number
690543|NCT01445873|Secondary|Other Pulmonary Arterial Hypertension (PAH)-Related Outcomes: Lung Transplantation|Number of participants who received an lung transplant during hospitalization.|Day 1 to Month 6|FAS; N=number of participants with hospitalizations during follow-up period.||participants|||Number
690544|NCT01445873|Secondary|Number of Hospitalizations|All hospitalizations during the follow-up period recorded in medical records.|Day 1 to Month 6|FAS||hospitalizations||95% Confidence Interval|Mean
690545|NCT01445873|Secondary|Other Pulmonary Arterial Hypertension (PAH)-Related Outcomes: Mortality|Number of participants who died during the follow-up period.|Day 1 to Month 6|FAS||participants|||Number
690546|NCT01445873|Secondary|Pulmonary Arterial Hypertension (PAH) Severity and Functional Status: Time to Clinical Worsening|Occurrence of any of the following: death, unplanned PAH-related hospitalization, initiation of epoprostenol, arterial septostomy, lung or heart/lung transplantation, ≥15% decrease from baseline in 6 minute walk test, signs/symptoms of right sided heart failure, and/or worsening WHO functional class.|Day 1 to Month 6|FAS||months||Standard Deviation|Mean
690547|NCT01445873|Secondary|Change From Baseline in Percent of Predicted Peak VO2|Difference between pre-index and follow-up value.|Baseline to Month 6|FAS; N=number of participants with ≥ 1 value recorded during follow-up period.||percent Vo2||95% Confidence Interval|Mean
690548|NCT01445873|Secondary|Change From Baseline in Borg Dyspnoea Score|Borg dyspnoea scale is a 10-point scale where following scores stands for severity of dyspnoea: 0 (no breathlessness at all); 0.5 (very very slight [just noticeable]); 1 (very slight); 2 (slight breathlessness); 3 (moderate); 4 (some what severe); 5 (severe breathlessness); 7 (very severe breathlessness); 9 (very very severe [almost maximum] and 10 (maximum). Difference between pre-index and follow-up value.|Baseline to Month 6|FAS; N=number of participants with ≥ 1 value recorded during follow-up period.||units on a scale||95% Confidence Interval|Mean
690550|NCT01445873|Secondary|Change From Baseline in Tricuspid Regurgitant Velocity|Difference between pre-index and follow-up value.|Baseline to Month 6|FAS; N=number of participants with pre-index and ≥ 1 follow-up value.||m/sec||95% Confidence Interval|Mean
695711|NCT01386632|Secondary|Overall Survival for Locally Advanced Head and Neck Squamous Cell Carcinoma Patients Receiving Concurrent Cisplatin, Radiation Therapy, and DCA.||2 years||||||
690555|NCT01445873|Secondary|Change From Baseline in Pulmonary Capillary Wedge Pressure|Difference between pre-index and follow-up value.|Baseline to Month 6|FAS; N=number of participants with pre-index and follow-up values.||mm Hg||95% Confidence Interval|Mean
690556|NCT01445873|Secondary|Change From Baseline in Mean Pulmonary Artery Pressure|Difference between pre-index and follow-up value.|Baseline to Month 6|Data not analyzed: no participants had pre-index and follow-up values reported for this outcome measure.||mm Hg||95% Confidence Interval|Mean
690557|NCT01445873|Secondary|Change From Baseline in Mean Right Atrial Pressure|Difference between pre-index and follow-up value.|Baseline to Month 6|FAS; N=number of participants with pre-index and ≥ 1 value recorded during follow-up period.||mm Hg||95% Confidence Interval|Mean
690558|NCT01445873|Secondary|Change From Baseline in World Health Organization (WHO) Functional Class of Pulmonary Hypertension|Class I: no limitation of usual (usl) physical activity (PA); PA does not increase(d) (incr) dyspnea (dys), fatigue (ftg), chest pain (CP), or syncope (syn); Class II: mild limitation of usl PA; no discomfort at rest, but normal PA causes incr dys, ftg, CP, or presyncope (presyn); Class III: marked limitation of PA; no discomfort at rest but < ordinary activity causes incr dys, ftg, CP, or presyn; Class IV: unable to perform any PA at rest; may have signs of right ventricular failure; sys and/or ftg at rest and symptoms are incr by almost any PA.|Baseline to Month 6|FAS; N=number of participants with pre-index (prior to Thelin initiation) and ≥ 1 WHO value recorded during follow-up.||participants|||Number
690559|NCT01445873|Secondary|Use of Other Pulmonary Arterial Hypertension (PAH)-Related Medications|Use of PAH-related medications other than Thelin described by class of agent received.|Day 1 to Month 6|FAS||percentage of participants|||Number
690560|NCT01445873|Primary|Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Daily Dosage|Daily dosage of Thelin based on information in the medical record for the baseline visit and all follow-up clinic visits.|Day 1 to Month 6|FAS||mg||95% Confidence Interval|Mean
690561|NCT01445873|Primary|Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Numbers of Therapy-days Dispensed|Duration of Thelin therapy from initial receipt until date of discontinuation of thelin therapy or the end of follow-up, whichever occurred first.|Day 1 to Month 6|Not analyzed: duration of Thelin therapy as number of therapy days dispensed was not summarized; this measure was reported as duration in months only.||days||Standard Deviation|Mean
690562|NCT01445873|Primary|Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Therapy Duration|Duration of Thelin therapy based on time from index date (Day 1 of treatment) until the date of discontinuation of Thelin therapy.|Day 1 to Month 6|FAS; participants without evidence of discontinuation of Thelin therapy were censored at the end of follow-up (at 6 months or death if prior to 6 months).||months||Standard Deviation|Mean
690563|NCT01445873|Primary|Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Therapy Discontinuation|Participants were designated as having discontinued Thelin therapy if there was evidence in the medical records that treatment had been terminated.|Day 1 to Month 6|FAS||participants|||Number
690564|NCT01445873|Primary|Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Therapy Switching|Participants with evidence of discontinuation of Thelin therapy and evidence of receipt of another PAH-related therapy not previously received during the study period.|Day 1 to Month 6|FAS||participants|||Number
690565|NCT01445873|Primary|Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Mean Time to Therapy Augmentation|Participants still receiving Thelin with evidence of receipt of another PAH-related therapy (eg. bosentan, sildenafil) not previously received during the study period. Mean time in months to therapy augmentation.|Day 1 to Month 6|Full analysis set (FAS): participants with idiopathic pulmonary arterial hypertension (PAH) or PAH secondary to connective tissue disease, receipt of Thelin for treatment of PAH, 6 months of follow-up (except for death) after initial receipt (IR) of Thelin, and at least 1 clinic visit in medical record during 6-month period after IR of Thelin.||months||Standard Deviation|Mean
690566|NCT01445847|Primary|Number of Patients With Laryngospasm Postoperatively|"There were 4 scores of laryngospasm:
0 = No Laryngospasm
= Stridor or partial laryngospasm
= Complete Laryngospasm
= Cyanosis"|within first 15 minutes post‐dose|Trial was terminated by data monitoring committee due to safety concerns||participants|||Number
690567|NCT01445769|Other Pre-specified|Dose Distribution at Week 24|Average Daily Dose for the last 28 days on study.|Week 24|Intent-to-treat population: All enrolled participants.||participants|||Number
690568|NCT01445769|Secondary|Number of Participants With Grade 3 or Grade 4 Adverse Events||Baseline to the end of the study|Safety population: All participants who took at least 1 dose of study drug.||participants|||Number
690569|NCT01445769|Secondary|Median Percentage Change in Abdominal Symptom Scores at Week 24.|Symptoms of myelofibrosis were assessed using a symptom diary, the modified MFSAF v2.0. Participants were issued a hand-held device to record answers to queries regarding 7 symptoms of myelofibrosis each night from Baseline through Week 24. The abdominal symptom score was the sum of 3 individual symptom scores (abdominal discomfort, pain under ribs on left side, and feeling of fullness [early satiety]).|Week 24|Intent-to-treat population: All enrolled participants. Note that three subjects did not have the Week 24 TSS; one subject dropped out for disease progression and two withdrew consent prior to the Week 24 TSS assessment. Thus 39 subjects were analyzed.||Percentage change||Full Range|Median
690570|NCT01445769|Secondary|Mean Percentage Change in Abdominal Symptom Scores at Week 24.|Symptoms of myelofibrosis were assessed using a symptom diary, the modified MFSAF v2.0. Participants were issued a hand-held device to record answers to queries regarding 7 symptoms of myelofibrosis each night from Baseline through Week 24. The abdominal symptom score was the sum of 3 individual symptom scores (abdominal discomfort, pain under ribs on left side, and feeling of fullness [early satiety]), each on a scale of 0 to 10. A higher score indicates worse symptoms. A negative change score indicates improvement. The Baseline abdominal symptom score was the mean of daily abdominal symptom scores from the last 7 consecutive days prior to the first study dose and ranged from 0 to 30. The Week 24 abdominal symptom score was the mean of the daily abdominal symptom scores from the last 28 consecutive days prior to the Week 24 visit and ranged from 0 to 30.|Week 24|Intent-to-treat population: All enrolled participants. Note that three subjects did not have the Week 24 TSS; one subject dropped out for disease progression and two withdrew consent prior to the Week 24 TSS assessment. Thus 39 subjects were analyzed.||Percentage change||Standard Deviation|Mean
692601|NCT01426438|Secondary|Change in LDL Cholesterol|Change in LDL cholesterol (mg/dL) from week 0 to week 24.|0 and 24 weeks|This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.||mg/dL||Inter-Quartile Range|Median
690571|NCT01445769|Secondary|Percentage of Participants With Clinically Notable Anemia|Clinically Notable Anemia was a pre-specified safety parameter examined at Weeks 12, 18 and 24 and defined as: 1) New onset Grade 3 or higher anemia in subjects who are transfusion independent at Baseline, 2) New onset transfusion dependence in subjects who are transfusion independent at Baseline, defined as receipt of ≥ 2 units in ≤ a 12-week interval, 3) 50% increase in transfusions compared to Baseline in subjects who are transfusion dependent at Baseline.|Baseline to Weeks 12, 18 and 24|Safety population: All participants who took at least 1 dose of study drug.||Percentage of participants|||Number
690572|NCT01445769|Secondary|Percentage of Participants With a ≥ 50% Improvement From Baseline in Their Transfusion Status or With New Transfusion Independence Status for Those Participants Who Were Transfusion Dependent at Baseline|"Transfusion dependence at Baseline is defined as subjects who received ≥ 2 units of red blood cell product(s) in the 12 consecutive weeks prior to the date of first dose.
Transfusion independence On-Study is defined as subjects who received 0 units of red blood cell products over any 12-week period after starting dosing with ruxolitinib.
Improvement in transfusion dependence On-Study is defined as a 50% or greater reduction in the frequency of red blood cell transfusions over any 12-week period after starting dosing with ruxolitinib."|Baseline to Week 24|Intent-to-treat population: All enrolled participants who were transfusion dependent at baseline (n=15).||Percentage of participants||95% Confidence Interval|Number
690573|NCT01445769|Secondary|Median Percent Change From Baseline in Palpable Spleen Length at Week 24|Spleen length was assessed by manual palpation. The edge of the spleen was determined by palpation and measured in centimeters, using a soft ruler, from the costal margin to the point of greatest splenic protrusion.|Baseline to Week 24|Intent-to-treat population: All enrolled participants. Note that one subject had a non-palpable spleen at baseline, one subject did not have the Week 24 spleen palpation performed; one subject dropped out for disease progression and two withdrew consent prior to the Week 24 spleen palpation. Thus 40 subjects were analyzed.||Percentage change||Full Range|Median
690574|NCT01445769|Secondary|Mean Percentage Change From Baseline in Palpable Spleen Length at Week 24|Spleen length was assessed by manual palpation. The edge of the spleen was determined by palpation and measured in centimeters, using a soft ruler, from the costal margin to the point of greatest splenic protrusion.|Baseline to Week 24|Intent-to-treat population: All enrolled participants. Note that one subject had a non-palpable spleen at baseline, one subject did not have the Week 24 spleen palpation performed; one subject dropped out for disease progression and two withdrew consent prior to the Week 24 spleen palpation. Thus 40 subjects were analyzed.||Percentage change||Standard Deviation|Mean
690575|NCT01445769|Secondary|Percentage of Participants With a ≥ 50% Improvement From Baseline in Total Symptom Score at Week 24|Symptoms of myelofibrosis were assessed using a symptom diary, the modified MFSAF v2.0. Participants were issued a hand-held device to record answers to queries regarding 7 symptoms of myelofibrosis each night from Baseline through Week 24. Symptoms assessed included night sweats, itching, abdominal discomfort, pain under ribs on left, feeling of fullness (early satiety), muscle/bone pain, and inactivity. The daily total symptom score was the sum of the first 6 individual symptom scores (each on a scale of 0-10). Inactivity was not included in the total score. The Baseline total symptom score was the mean of daily total symptom scores from the last 7 consecutive days prior to the first study dose and ranged from 0 to 60. The Week 24 total symptom score was the mean of the daily total symptom scores from the last 28 consecutive days prior to the Week 24 visit and ranged from 0 to 60. A higher score indicates worse symptoms. A negative change score indicates improvement.|Baseline to Week 24|Intent-to-treat population: All enrolled participants.||Percentage of participants||95% Confidence Interval|Number
690576|NCT01445769|Secondary|Percentage of Participants With a ≥ 10% Reduction From Baseline in Spleen Volume at Week 24|Spleen volume was measured using magnetic resonance imaging (MRI) or computed tomography (CT) scan. The MRIs were read in the central imaging laboratory. Spleen volume was obtained by outlining the circumference of the organ and determining the volume using the technique of least squares. MRI was the preferred method for obtaining spleen volume data. CT scans were performed if the participant was not a candidate for MRI. The CT scans were processed by the same central laboratory used for MRIs. The same method (MRI or CT) was used for all visits for a given participant unless a new contraindication to the use of MRI (eg, pacemaker insertion) occurred.|Baseline to Week 24|Intent-to-treat population: All enrolled participants.||Percentage of participants||95% Confidence Interval|Number
690577|NCT01445769|Secondary|Percentage of Participants With a ≥ 35% Reduction From Baseline in Spleen Volume at Week 24|Spleen volume was measured using magnetic resonance imaging (MRI) or computed tomography (CT) scan. The MRIs were read in the central imaging laboratory. Spleen volume was obtained by outlining the circumference of the organ and determining the volume using the technique of least squares. MRI was the preferred method for obtaining spleen volume data. CT scans were performed if the participant was not a candidate for MRI. The CT scans were processed by the same central laboratory used for MRIs. The same method (MRI or CT) was used for all visits for a given participant unless a new contraindication to the use of MRI (eg, pacemaker insertion) occurred.|Baseline to Week 24|Intent-to-treat population: All enrolled participants.||Percentage of participants||95% Confidence Interval|Number
690578|NCT01445769|Secondary|Median Percent Change From Baseline in the Total Symptom Score at Week 24|Symptoms of myelofibrosis were assessed using a symptom diary, the modified MFSAF v2.0. Participants were issued a hand-held device to record answers to queries regarding 7 symptoms of myelofibrosis each night from Baseline through Week 24. Symptoms assessed included night sweats, itching, abdominal discomfort, pain under ribs on left, feeling of fullness (early satiety), muscle/bone pain, and inactivity. The daily TSS was the sum of the first 6 individual symptom scores (each on a scale of 0-10). Inactivity was not included in the total score. The Baseline total symptom score was the mean of daily total symptom scores from the last 7 consecutive days prior to the first study dose and ranged from 0 to 60. The Week 24 total symptom score was the mean of the daily total symptom scores from the last 28 consecutive days prior to the Week 24 visit and ranged from 0 to 60. A higher score indicates worse symptoms. A negative change score indicates improvement.|Baseline to Week 24|Intent-to-treat population: All enrolled participants. Note that 3 subjects did not have the Week 24 TSS; one subject dropped out for disease progression and two withdrew consent prior to the Week 24 TSS assessment. Thus 39 subjects were analyzed.||Percentage change||Full Range|Median
691859|NCT01435031|Secondary|Occurrence of Stent Fracture at Target Lesion|Assessed by fluoroscopy in patients undergoing clinically-driven angiographic follow-up.|1 year|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||percentage of participants|||Number
690579|NCT01445769|Secondary|Mean Percentage Change From Baseline in the Total Symptom Score at Week 24|Symptoms of myelofibrosis were assessed using a symptom diary, the modified Myelofibrosis Symptom Assessment Form (MFSAF v2.0). Participants were issued a hand-held device to record answers to queries regarding 7 symptoms of myelofibrosis each night from Baseline through Week 24. Symptoms assessed included night sweats, itching, abdominal discomfort, pain under ribs on left, feeling of fullness (early satiety), muscle/bone pain, and inactivity. The daily total symptom score (TSS) was the sum of the first 6 individual symptom scores (each on a scale of 0-10). Inactivity was not included in the total score. The Baseline TSS was the mean of daily total symptom scores from the last 7 consecutive days prior to the first study dose and ranged from 0 to 60. The Week 24 TSS was the mean of the daily total symptom scores from the last 28 consecutive days prior to the Week 24 visit and ranged from 0 to 60. A higher score indicates worse symptoms. A negative change score indicates improvement.|Baseline to Week 24|Intent-to-treat population: All enrolled participants. Note that 3 subjects did not have the Week 24 TSS; one subject dropped out for disease progression and two withdrew consent prior to the Week 24 TSS assessment. Thus 39 subjects were analyzed.||Percentage change||Standard Deviation|Mean
690580|NCT01445769|Primary|Median Percent Change From Baseline in Spleen Volume at Week 24|Spleen volume was measured using magnetic resonance imaging (MRI) or computed tomography (CT) scan. The MRIs were read in the central imaging laboratory. Spleen volume was obtained by outlining the circumference of the organ and determining the volume using the technique of least squares. MRI was the preferred method for obtaining spleen volume data. CT scans were performed if the participant was not a candidate for MRI. The CT scans were processed by the same central laboratory used for MRIs. The same method (MRI or CT) was used for all visits for a given participant unless a new contraindication to the use of MRI (eg, pacemaker insertion) occurred.|Baseline to Week 24|Intent-to-treat population: All enrolled participants. Note that 2 subjects did not have the Week 24 MRI; one subject dropped out for disease progression and two withdrew consent prior to the Week 24 MRI. Thus 40 subjects were analyzed.||: Percentage change||Full Range|Median
690581|NCT01445769|Primary|Mean Percentage Change From Baseline in Spleen Volume at Week 24|Spleen volume was measured using magnetic resonance imaging (MRI) or computed tomography (CT) scan. The MRIs were read in the central imaging laboratory. Spleen volume was obtained by outlining the circumference of the organ and determining the volume using the technique of least squares. MRI was the preferred method for obtaining spleen volume data. CT scans were performed if the participant was not a candidate for MRI. The CT scans were processed by the same central laboratory used for MRIs. The same method (MRI or CT) was used for all visits for a given participant unless a new contraindication to the use of MRI (eg, pacemaker insertion) occurred.|Baseline to Week 24|Intent-to-treat population: All enrolled participants. Note that 2 subjects did not have the Week 24 MRI; one subject dropped out for disease progression and two withdrew consent prior to the Week 24 MRI. Thus 40 subjects were analyzed.||Percentage change||Standard Deviation|Mean
690582|NCT01445678|Secondary|The Percentage of Subjects With Clinical Response at LFU Visit in the ME Population|Clinical response is clinical cure at TOC and no signs and symptoms recur or worsen since the TOC visit|LFU; 38 to 45 days after first study drug administration|Microbiologically evaluable: Treated patients, complied with protocol, with pathogens susceptible to study drug.||percentage of subjects|||Number
690583|NCT01445678|Secondary|The Percentage of Subjects With Clinical Response at Long Term Follow-Up (LFU) in the MITT Population|Clinical response is clinical cure at TOC and no signs and symptoms recur or worsen since the TOC visit.|LFU; 38 to 45 days after first study drug administration|MITT: Randomized patients, with baseline pathogen.||percentage of subjects|||Number
690584|NCT01445678|Secondary|The Percentage of Subjects With Clinical Response at End of Therapy in the ME Population|Clinical response is complete resolution or significant improvement in signs and symptoms of the index infection, such that no additional antibacterial therapy or surgical or drainage procedure was required for the index infection.|EOT; Within 24 hours of last study drug administration|Microbiologically evaluable: Treated patients, complied with protocol, with pathogens susceptible to study drug.||percentage of subjects|||Number
690585|NCT01445678|Secondary|The Percentage of Subjects With Clinical Response at End of Therapy (EOT) Visit in the MITT Population|Clinical response is complete resolution or significant improvement in signs and symptoms of the index infection, such that no additional antibacterial therapy or surgical or drainage procedure was required for the index infection.|EOT; Within 24 hours of last study drug administration|MITT: Microbiological Intent-to-Treat: Randomized patients, with baseline pathogen.||percentage of subjects|||Number
690586|NCT01445678|Secondary|The Percentage of Subjects With Microbiological Outcome of Success at the TOC Visit in the Microbiologically Evaluable (ME) Population|Success is eradication (absence of the baseline pathogen in a specimen appropriately obtained from the original site of infection) or presumed eradication (absence of material to culture in a subject who was assessed as a clinical cure) for each baseline pathogen|TOC; 26-30 days after start of study drug administration|Microbiologically evaluable: Treated patients, complied with protocol, with pathogens susceptible to study drug.||percentage of subjects|||Number
690587|NCT01445678|Primary|The Percentage of Subjects With Clinical Outcome of Cure at the Test of Cure (TOC) Visit in the Microbiological Intent to Treat (MITT) Population|Clinical cure is complete resolution or significant improvement in signs and symptoms of the index infection, such that no additional antibacterial therapy or surgical or drainage procedure was required for the index infection.|TOC; 26-30 days after start of study drug administration|MITT: Randomized patients, with baseline pathogen.||percentage of subjects|||Number
690588|NCT01445652|Primary|Subjective Vision With Correction Type|"Participant responded to an SMS message: Please rate your happiness (H) and vision (V) with your [contact lenses/spectacles]: 1=very poor; 2=poor; 3=neither; 4=good; and 5=very good. eg H2V4. Please send N if in you are not wearing [contact lenses/spectacles]."|Month 6|This reporting group includes all participants who sent in an SMS response.||Units on a scale||Standard Deviation|Mean
690589|NCT01445652|Primary|Subjective Happiness With Correction Type|"Participant responded to an SMS message: Please rate your happiness (H) and vision (V) with your [contact lenses/spectacles]: 1=very poor; 2=poor; 3=neither; 4=good; and 5=very good. eg H2V4. Please send N if in you are not wearing [contact lenses/spectacles]."|Month 6|This reporting group includes all participants who sent in an SMS response.||Units on a Scale||Standard Deviation|Mean
694327|NCT01402115|Secondary|Changes in bALP(Bone-specific Alkaline Phosphatase)|bALP(bone-specific alkaline phosphatase) was measured in study visit 1(0 week) and visit 3(12 week).|12weeks|per protocol analysis||U/L||Standard Deviation|Mean
690590|NCT01445626|Secondary|Time to Improvement of 3 Lines or More in BCVA|Time to improvement of 3 lines or more in BCVA is defined as the number of days after the first injection of OZURDEX® to achieve an improvement of 3 or more lines read correctly compared to baseline. BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worse) to 20 (best).|Baseline, Up to 12 months|All participants with data available for analysis.||Days||Full Range|Median
690591|NCT01445626|Secondary|Time to Improvement of 2 Lines or More in BCVA|Time to improvement of 2 lines or more in BCVA is defined as the number of days after the first injection of OZURDEX® to achieve an improvement of 2 or more lines read correctly compared to baseline. BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worse) to 20 (best).|Baseline, Up to 12 months|All participants with data available for analysis.||Days||Full Range|Median
690592|NCT01445626|Secondary|Change From Baseline in Central Retinal Thickness by Optical Coherence Tomography (OCT) 7 to 12 Weeks Following the Last Injection|Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed in the study eye after pupil dilation at baseline and 7 to 12 weeks after the last injection. A negative change from baseline indicates improvement.|Baseline, 7 to 12 weeks following the last injection|All participants with data available for analysis.||µm||Standard Deviation|Mean
690593|NCT01445626|Secondary|Percentage of Patients With an Increase of 3 Lines or More in BCVA|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worse) to 20 (best). An increase of 3 or more lines read correctly compared to baseline is an improvement.|Baseline, Up to 12 months|All treated participants.||Percentage of participants|||Number
690594|NCT01445626|Secondary|Percentage of Patients With an Increase of 2 Lines or More in BCVA|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worse) to 20 (best). An increase of 2 or more lines read correctly compared to baseline is an improvement.|Baseline, Up to 12 months|All treated participants.||Percentage of participants|||Number
690595|NCT01445626|Secondary|Change From Baseline in Best Corrected Visual Acuity (BCVA) 7 to 12 Weeks Following the Last Injection|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of letters ranging from 0 (worse) to 100 (best). The change in BCVA was calculated using the most improved number of letters read correctly between 7 and 12 weeks following the last injection of OZURDEX® - the number of letters read correctly at baseline. A positive change from baseline indicates improvement.|Baseline, 7 to 12 weeks following the last injection|All participants with data available for analysis.||Letters||Standard Deviation|Mean
690596|NCT01445626|Primary|Time to OZURDEX® Re-injection|Time to OZURDEX® re-injection is the time in days between the first and second OZURDEX® injections.|Up to 12 months|All participants with data available for analysis.||Days||Standard Deviation|Mean
690597|NCT01445613|Secondary|Clinical Success|Clinical success is defined as the attainment of < 50% residual stenosis of the target lesion and absence of a death or stroke 30-day post-procedure.|30 days|FAS population||percentage of participants||95% Confidence Interval|Number
690598|NCT01445613|Secondary|Freedom From Clinically Driven Target Lesion Revascularization|Target Lesion Revascularization (TLR) is designated as clinically driven if the subject has recurring symptoms or has become newly symptomatic and has stenosis >50% in the stented lesion, or is asymptomatic and has a stenosis of >80% in the stented lesion.|365 days|FAS population||percentage of participants|||Number
690599|NCT01445613|Secondary|Freedom From Clinically Driven Target Lesion Revascularization|Target Lesion Revascularization (TLR) is designated as clinically driven if the subject has recurring symptoms or has become newly symptomatic and has stenosis >50% in the stented lesion, or is asymptomatic and has a stenosis of >80% in the stented lesion.|180 days|FAS population||percentage of participants|||Number
690600|NCT01445613|Secondary|Freedom From Clinically Driven Target Lesion Revascularization|Target Lesion Revascularization (TLR) is designated as clinically driven if the subject has recurring symptoms or has become newly symptomatic and has stenosis >50% in the stented lesion, or is asymptomatic and has a stenosis of >80% in the stented lesion.|30 days|FAS population||percentage of participants|||Number
690601|NCT01445613|Secondary|Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Through 1 Year by Age||365 days|FAS population||percentage of participants|||Number
690602|NCT01445613|Secondary|Composite of Peri-procedural Death and Stroke by Age||30 days|FAS population. The number of participants analyzed includes subjects with data available at that time frame.||percentage of participants||95% Confidence Interval|Number
690603|NCT01445613|Secondary|Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Through 1 Year by Symptomatic Status||365 days|FAS population||percentage of participants|||Number
690604|NCT01445613|Secondary|Composite of Peri-procedural Death and Stroke by Symptomatic Status||30 days|FAS population||percentage of participants||95% Confidence Interval|Number
690605|NCT01445613|Primary|Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Between 31 and 365 Days||365 days|FAS population||percentage of participants|||Number
690606|NCT01445613|Secondary|Death and All Stroke||30 Days|FAS population. The number of participants analyzed includes subjects with data available at that time frame.||percentage of participants||95% Confidence Interval|Number
690607|NCT01445613|Primary|Composite Rate of Peri-procedural (Within 30 Days of the Procedure) Death and Stroke, Plus Ipsilateral Stroke Between Day 31 and 1 Year (365 Days)||0 to 365 days|FAS population||percentage of participants||Standard Error|Mean
690608|NCT01445548|Secondary|Development of Exudative Age-Related Macular Degeneration (AMD) as Measured by Optical Coherence Tomography (OCT) at 12 Months Compared to Baseline||Baseline and 12 Months||||||
690618|NCT01445548|Secondary|Absolute Change in Drusen Area Based on Masked, Digital Grading of Fundus Photography by an External Reading Center, in the Study Eye at 12 Months Compared to Baseline.|"The total area occupied by drusen was determined using planimetry for color stereoscopic fundus images by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).
One Macular Photocoagulation Study Disc Area (MPS DA) is equivalent to 1.77 mm^2 on the retina."|Baseline and Month 12|The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 3 had drusen area graded at 12 months.||MPS DA|Participants|Standard Deviation|Mean
690609|NCT01445548|Secondary|Relative Change in Area of GA, as Measured by Fundus Autofluorescence (FAF) Imaging Using a Modified Fundus Camera (mFC), in the Fellow Eye at 12 Months Compared to Baseline.|"Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for FAF images obtained with a mFC by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).
This outcome measure was calculated by dividing the absolute change in the total area of GA in the study eye at 12 months by the baseline value."|Baseline and Month 12|The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 5 were followed for 12 months.||Ratio|Participants|Standard Deviation|Mean
690610|NCT01445548|Secondary|Relative Change in Area of GA, as Measured by Fundus Autofluorescence (FAF) Imaging Using a Modified Fundus Camera (mFC), in the Study Eye at 12 Months Compared to Baseline.|"Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for FAF images obtained with a mFC by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).
This outcome measure was calculated by dividing the absolute change in the total area of GA in the study eye at 12 months by the baseline value."|Baseline and Month 12|The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 5 were followed for 12 months.||Ratio|Participants|Standard Deviation|Mean
690611|NCT01445548|Secondary|Relative Change in Area of GA, as Measured by Fundus Autofluorescence (FAF) Imaging Using a Confocal Scanning Laser Ophthalmoscope (SLO), in the Fellow Eye at 12 Months Compared to Baseline.|"Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for FAF images obtained with a SLO by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).
This outcome measure was calculated by dividing the absolute change in the total area of GA in the study eye at 12 months by the baseline value."|Baseline and Month 12|The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 5 were followed for 12 months.||Ratio|Participants|Standard Deviation|Mean
690612|NCT01445548|Secondary|Relative Change in Area of GA, as Measured by Fundus Autofluorescence (FAF) Imaging Using a Confocal Scanning Laser Ophthalmoscope (SLO), in the Study Eye at 12 Months Compared to Baseline.|"Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for FAF images obtained with a SLO by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).
This outcome measure was calculated by dividing the absolute change in the total area of GA in the study eye at 12 months by the baseline value."|Baseline and Month 12|||Ratio|Participants|Standard Deviation|Mean
690613|NCT01445548|Secondary|Absolute Change in Area of GA, as Measured by Fundus Autofluorescence (FAF) Imaging Using a Confocal Scanning Laser Ophthalmoscope (SLO), in the Fellow Eye at 12 Months Compared to Baseline.|"Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss.The area of GA was determined using planimetry for FAF images obtained with a SLO by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).
This outcome measure was calculated by subtracting the GA value for the study eye at baseline from the GA value for the study eye at Month 12."|Baseline and Month 12|The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 5 were followed for 12 months.||mm^2|Participants|Standard Deviation|Mean
690614|NCT01445548|Secondary|Absolute Change in Area of GA, as Measured by Fundus Autofluorescence (FAF) Imaging Using a Confocal Scanning Laser Ophthalmoscope (SLO), in the Study Eye at 12 Months Compared to Baseline.|"Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for FAF images obtained with a SLO by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).
This outcome measure was calculated by subtracting the GA value for the study eye at baseline from the GA value for the study eye at Month 12."|Baseline and Month 12|The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 5 were followed for 12 months.||mm^2|Participants|Standard Deviation|Mean
690615|NCT01445548|Secondary|Absolute Change in Area of GA, as Measured by Fundus Autofluorescence (FAF) Imaging Using a Modified Fundus Camera (mFC), in the Fellow Eye at 12 Months Compared to Baseline.|"Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for FAF images obtained with a mFC by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).
This outcome measure was calculated by subtracting the GA value for the study eye at baseline from the GA value for the study eye at Month 12."|Baseline and Month 12|The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 5 were followed for 12 months.||mm^2|Participants|Standard Deviation|Mean
690616|NCT01445548|Secondary|Absolute Change in Area of GA, as Measured by Fundus Autofluorescence (FAF) Imaging Using a Modified Fundus Camera (mFC), in the Study Eye at 12 Months Compared to Baseline.|"Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for FAF images obtained with a mFC by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).
This outcome measure was calculated by subtracting the GA value for the study eye at baseline from the GA value for the study eye at Month 12."|Baseline and Month 12|The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 5 were followed for 12 months.||mm^2|Participants|Standard Deviation|Mean
690617|NCT01445548|Secondary|Absolute Change in Drusen Area Based on Masked, Digital Grading of Fundus Photography by an External Reading Center, in the Fellow Eye at 12 Months Compared to Baseline.|"The total area occupied by drusen was determined using planimetry for color stereoscopic fundus images by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).
One Macular Photocoagulation Study Disc Area (MPS DA) is equivalent to 1.77 mm^2 on the retina."|Baseline and Month 12|The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 3 had drusen area graded at 12 months.||MPS DA|Participants|Standard Deviation|Mean
690619|NCT01445548|Secondary|Relative Change in Total Area of Macular GA, Based on Masked, Digital Grading of Fundus Photography by an External Reading Center, in the Fellow Eye at 12 Months Compared to Baseline.|"Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for color stereoscopic fundus images by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).
This outcome measure was calculated by dividing the absolute change in the total area of GA in the study eye at 12 months by the baseline value."|Baseline and Month 12|||Ratio||Standard Deviation|Mean
690620|NCT01445548|Secondary|Relative Change in Total Area of Macular GA, Based on Masked, Digital Grading of Fundus Photography by an External Reading Center, in the Study Eye at 12 Months Compared to Baseline.|"Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for color stereoscopic fundus images by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).
This outcome measure was calculated by dividing the absolute change in the total area of GA in the study eye at 12 months by the baseline value."|Baseline and Month 12|The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 5 were followed for 12 months.||Ratio||Standard Deviation|Mean
690621|NCT01445548|Secondary|Absolute Change in Total Area of Macular GA, Based on Masked, Digital Grading of Fundus Photography by an External Reading Center, in the Fellow Eye at 12 Months Compared to Baseline.|"Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for color stereoscopic fundus images by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).
This outcome measure was calculated by subtracting the GA value for the study eye at baseline from the GA value for the study eye at Month 12."|Baseline and Month 12|The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 5 were followed for 12 months.||mm^2|Participants|Standard Deviation|Mean
690622|NCT01445548|Secondary|Absolute Change in Total Area of Macular GA, Based on Masked, Digital Grading of Fundus Photography by an External Reading Center, in the Study Eye at 12 Months Compared to Baseline.|"Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for color stereoscopic fundus images by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).
This outcome measure was calculated by subtracting the GA value for the study eye at baseline from the GA value for the study eye at Month 12."|Baseline and Month 12|The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 5 were followed for 12 months.||mm^2|Participants|Standard Deviation|Mean
690623|NCT01445548|Secondary|Changes in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) in the Fellow Eye at 12 Months Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20. One eye (the study eye) was initially randomized to receive intravitreal sirolimus and the fellow eye was observed as the control.|Baseline and Month 12|The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 5 were followed for 12 months.||ETDRS letters|Participants|Standard Deviation|Mean
690624|NCT01445548|Secondary|Changes in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) in the Study Eye at 12 Months Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20. One eye (the study eye) was initially randomized to receive intravitreal sirolimus and the fellow eye was observed as the control.|Baseline and Month 12|The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 5 were followed for 12 months.||ETDRS letters|Participants|Standard Deviation|Mean
690625|NCT01445548|Primary|Rate of Change in Area of Geographic Atrophy (GA), Based on Masked, Digital Grading of Fundus Photography by an External Reading Center, in the Fellow Eye at 12 Months Compared to Baseline.||Baseline and Month 12|The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 5 were followed for 12 months.||mm^2/month|Participants|Standard Deviation|Mean
690626|NCT01445548|Primary|Rate of Change in Area of Geographic Atrophy (GA), Based on Masked, Digital Grading of Fundus Photography by an External Reading Center, in the Study Eye at 12 Months Compared to Baseline.||Baseline and Month 12|The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 5 were followed for 12 months.||mm^2/month|Participants|Standard Deviation|Mean
690627|NCT01445028|Primary|Rate of Retinal Attachment|We will evaluate all patients for retinal attachment at 3 and 6-months following enrollment in the study.|3 months|||Participants|||Count of Participants
690628|NCT01444924|Secondary|Pain Scores|Pain scores by the Visual Analog Scale (VAS) and Wisconsin Brief Pain Inventory (BPI), collected once the day of surgery (at least 2 hours post-op), and both the morning and afternoon/evening on post-operative day #1.|2 days||||||
690629|NCT01444924|Primary|24 Hour Post Operative Opioid Consumption, Converted to Intravenous Morphine Equivalents||24 hours|||mg||Standard Deviation|Mean
690630|NCT01444911|Secondary|Vaginal Length|Change in vaginal length as measured from baseline to 6 months.|At baseline and 6 months|||Centimeters||Full Range|Mean
690631|NCT01444911|Secondary|FACT-G Score|The FACT-G (Functional Assessment of Cancer Therapy - General) questionnaire assesses general cancer quality-of-life measure for evaluating patients receiving cancer treatment. Scores range from 0 to 108, where 0 is low well-being and 108 is the highest well-being possible. Difference in score from baseline to 6 months is reported.|At baseline and 6 months|||units on a scale||Full Range|Mean
690659|NCT01444651|Primary|Change in Insulin Resistance From Baseline to 3 Months, as Measured by HOMA-IR|The primary endpoint is defined as the treatment group difference in the change in insulin resistance (baseline HOMA-IR minus 3-month HOMA-IR). HOMA-IR = [fasting glucose * fasting insulin]/405|Baseline and 3 months|||mg*microunits/dL*mL||Standard Deviation|Mean
690632|NCT01444911|Secondary|Change in Marinoff Scale at 6 Months|"The Marinoff dyspareunia scale measures pain with intercourse, measured from 0-3, according to the following scale:
0 = no pain with intercourse
= pain with intercourse that doesn't prevent the completion
= pain with intercourse requiring interruption or discontinuance
= pain with intercourse preventing any intercourse
Difference in Marinoff scores reported, value at 6 months minus value at baseline."|At baseline and 6 months|Data for eleven subjects (2 from Standard of Care and 9 from VRP) was not collected at one or more study visits, and the change in scores could not be calculated.||units on a scale||Full Range|Mean
690633|NCT01444911|Primary|Change From Baseline in Female Sexual Function Index (FSFI) Score at 6 Months|Female Sexual Function Index (FSFI), uses a 19-item sexual functioning questionnaire to rate sexual function between 2.0 and 36.0, where 2.0 is low sexual function and 36.0 is high sexual function. Difference in FSFI scores are reported.|At baseline and 6 months|||Units on a scale||Full Range|Mean
690634|NCT01444898|Primary|Appetite Scores|"Appetite scores using a syndrome-validated hyperphagia questionnaire
11 item questionnaire divided into subcategories of behavior (5 questions), drive (4 questions), severity (2 questions). Tallied and analyzed as total and subcategory scores. Each question scored 1-5 with higher scores correlating with worse hyperphagia.
Possible ranges: Total 11-55, behavior 5-25, drive 4-20, severity 2-10"|6 months|||units on a scale||Standard Deviation|Mean
690635|NCT01444898|Primary|Change in Pancreatic Peptide (PP)||6 months|||pg ml^-1||Standard Deviation|Mean
690636|NCT01444898|Primary|Change in Acy Ghr||6 months|||pg ml^-1||Standard Deviation|Mean
690637|NCT01444898|Primary|Change in Leptin||6 months|||ng ml^-1||Standard Deviation|Mean
690638|NCT01444898|Primary|Change in Insulin Levels||6 months|||u/U ml^-1||Standard Deviation|Mean
690639|NCT01444898|Primary|Change in HbA1c (%)||6 months|||percentage||Standard Deviation|Mean
690640|NCT01444898|Primary|Change in BMI Z-Score||6 months|||units on a scale||Standard Deviation|Mean
690641|NCT01444898|Primary|% Change in Body Mass Index (BMI)|Prior to analysis, distributions were evaluated for normality and natural log transformation was performed to analyse data not normally distributed. Data are presented as mean ±SD unless not normally distributed, in which case they are presented as median with intra-quartile ranges (25th and 75th percentiles). Within-subject changes between visits were analysed by mixed model repeated measures. When the overall F-test for difference among visits was significant, Dunnett-adjusted pairwise comparisons were made between baseline and each subsequent visit.|6 months|||% change in BMI||Standard Deviation|Mean
690642|NCT01444898|Primary|Change in Weight|Change in weight (kg) after 6 months of treatment with study drug. Described as mean +/- SD|6 months|||kg||Standard Deviation|Mean
690643|NCT01444781|Secondary|Number of Participants Reporting a Solicited Injection Site Following Booster Vaccination With Prevenar Vaccine|Solicited injection site: Pain, Erythema, Swelling, and Extensive swelling of vaccinated limb. Grade 3 Injection site: Pain, cries if limb is moved or reduced movement; Erythema and Swelling, ≥5 cm; and Extensive swelling of limb, Severe.|Day 0 up to Day 7 after final booster vaccination|Solicited injection site reactions were assessed in the Safety Analysis Set.||Participants|||Number
690644|NCT01444781|Secondary|Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine|Solicited injection site: Pain, Erythema, Swelling, and Extensive swelling of vaccinated limb; Solicited systemic reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability. Grade 3 Injection site: Pain, Cries if limb is moved or reduced movement; Erythema and Swelling, ≥5 cm; Extensive swelling of limb, Severe. Grade 3 Systemic reactions: Pyrexia (Temperature) >39.5˚C; Vomiting, ≥ 6 times per 24 hours or needing parenteral nutrition; Crying, >3 hours; Somnolence, Sleeping often or difficulty waking; Anorexia, refuses ≥3 meals; and Irritability, Inconsolable.|Day 0 up to Day 7 after final booster vaccination|Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set, which includes all persons who received the study or control vaccine.||Participants|||Number
690645|NCT01444781|Secondary|Summary of Geometric Mean Titers to Vaccine Antigens After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine by Age Strata|Anti-Diphtheria antibodies were measured by a toxin neutralization test. Anti-FHA antibodies were measured by ELISA. Anti-Poliovirus types 1, 2, and 3 were measured by neutralization assay.|Day 30 after final booster vaccination|Geometric mean titers to vaccine antigens were assessed in the Per Protocol Analysis Set.||Titers||95% Confidence Interval|Geometric Mean
690646|NCT01444781|Secondary|Summary of Booster Response to Vaccine Antigens Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine By Age Strata|Anti-PT and anti-FHA antibodies were measured by ELISA.|Day 0 (pre-vaccination) and Day 30 after final booster vaccination|Booster responses to vaccine antigens were assessed in the Per Protocol Analysis Set.||Participants|||Number
690647|NCT01444781|Secondary|Summary of Geometric Mean Titers to Prevenar Vaccine Antibodies After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine|Anti-Streptococcus pneumococcal type specific antibody (anti-Pn PS) was measured by ELISA.|Day 30 after final booster vaccination|Geometric mean titers against Prevenar vaccine serotypes were assessed in the Per Protocol Analysis Set.||Titers||95% Confidence Interval|Geometric Mean
690648|NCT01444781|Secondary|Summary of Immune Response Against Serotypes in the Prevenar Vaccine After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine|Anti-Streptococcus pneumococcal type specific antibody (anti-Pn PS) was measured by ELISA. Booster response to pneumococcal serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F was defined as antibody titers ≥0.35 µg/mL at Day 30.|Day 30 after final booster vaccination|Antibody responses against Prevenar vaccine serotypes were assessed in the Per-protocol Analysis Set.||Participants|||Number
690660|NCT01444456|Secondary|Percentage of Participants With Increase in Hemoglobin ≥ 1 g/dL at Any Time|The percentage of participants with increase in hemoglobin (≥ 1 g/dL) at any time from Day 2 until the end-of-study assessment (Week 13).|From Baseline to Week 13|Primary analysis set||percentage of participants|||Number
690692|NCT01444378|Secondary|Quality of Life Measures : Physical Component Summary (PCS)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|6 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||score on a scale||Standard Deviation|Mean
690649|NCT01444781|Secondary|Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.|"Anti-Diphtheria antibodies were measured by a toxin neutralization test. Anti-Tetanus, anti-PT, and anti-FHA antibodies were measured by ELISA. Anti-Poliovirus types 1, 2, and 3 were measured by neutralization assay. Anti-Hepatitis B antibodies were measured by the commercially available VITROS ECi/ECiQ Immunodiagnostic System. Anti-PRP antibodies were measured using a Farr type radioimmunoassay that used radiolabeled PRP (3H PRP) in the presence of 36Cl (volume marker).
Day 140 = Primary series; Day 0 = Pre-booster; and Day 30 = Post-booster titers."|Day 140 after primary vaccination, Day 0 (pre-vaccination), and Day 30 after final booster vaccination|Geometric mean titers against vaccine antibodies were assessed in the Per Protocol Analysis Set.||Titers||95% Confidence Interval|Geometric Mean
690650|NCT01444781|Primary|Summary of Hepatitis B and Haemophilus Influenzae Type B Post Primary Series Antibodies; Antibody Persistence, and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine|"Anti-Hepatitis B antibodies were measured by the commercially available VITROS ECi/ECiQ Immunodiagnostic System. Anti-Haemophilus influenza type b capsular polyribosyl ribitol phosphate (PRP) antibodies were measured using a Farr type radioimmunoassay that used radiolabeled PRP (3H PRP) in the presence of 36Cl (volume marker). Anti-Hepatitis antibody titers ≥ 10 mIU/mL and ≥ 100 mIU/mL at Day 0 confirmed antibody persistence and booster response at Day 30. Anti-PRP antibody titers ≥ 0.15 µg/ml and ≥ 1.0 µg/ml at Day 0 confirmed antibody persistence and booster response at Day 30.
Day 140 = Primary series; Day 0 = Pre-booster; and Day 30 = Post-booster titers."|Day 140 after primary vaccination, Day 0 (pre-vaccination), and Day 30 after final booster vaccination|Antibody responses were assessed in the Per Protocol Analysis Set.||Participants|||Number
690651|NCT01444781|Primary|Summary of Polio Antibodies Post Primary Series, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine|"Anti-Poliovirus types 1, 2, and 3 antibodies were measured by neutralization assay. Antibody persistence for anti-Poliovirus 1, 2, and 3 was defined as antibody titers ≥8 (1/dil) before the booster dose at Day 0. Booster response to Poliovirus 1, 2, and 3 was defined as antibody titers ≥8 (1/dil) at Day 30.
Day 140 = Primary series; Day 0 = Pre-booster; and Day 30 = Post-booster titers."|Day 140 after primary vaccination, Day 0 (pre-vaccination), and Day 30 after final booster vaccination|Antibody responses were assessed in the Per Protocol Analysis Set.||Participants|||Number
690652|NCT01444781|Primary|Summary of Pertussis and Filamentous Haemagglutinin Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine|"Anti-Pertussis toxin (PT) and anti-Filamentous haemagglutinin (FHA) antibodies were measured by ELISA. Antibody persistence for anti-PT and anti-FHA was defined as titers ≥ lower limit of quantitation (LLOQ) before the booster dose at Day 0. Booster responses for PT and FHA at Day 30 were defined as: pre-vaccination antibody concentrations < LLOQ and post-vaccination levels ≥ 4 x LLOQ, pre-vaccination antibody concentrations ≥ LLOQ but < 4 x LLOQ and post/pre vaccination ≥ 4, and pre-vaccination antibody concentrations ≥ 4 x LLOQ and post/pre-vaccination ≥ 2.
Day 140 = Primary series; Day 0 = Pre-booster; and Day 30 = Post-booster titers."|Day 140 after primary vaccination, Day 0 (pre-vaccination), and Day 30 after final booster vaccination|Antibody responses were assessed in the Per-protocol Analysis Set.||Participants|||Number
690653|NCT01444781|Primary|Summary of Diphtheria and Tetanus Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV Hep B-PRP T Vaccine or Infanrix Hexa Vaccine|"Anti-Diphtheria (D) antibodies were measured by a toxin neutralization test. Anti-Tetanus (T) antibodies were measured by enzyme-linked immunosorbent assay (ELISA). Antibody persistence for anti-Diphtheria and anti-Tetanus antibodies was defined as titers ≥0.01 IU/mL and ≥0.1 IU/mL before the booster dose at Day 0. Booster response to Diphtheria and Tetanus was defined as antibody titers ≥0.01 IU/mL and ≥0.1 IU/mL at Day 30 post-booster vaccination.
Day 140 = Primary series; Day 0 = Pre-booster; and Day 30 = Post-booster titers"|Day 140 (Primary series) and Day 0 (Pre-booster)|Antibody responses were assessed in the Per Protocol Analysis Set, which includes all persons who did not have any protocol deviations.||Participants|||Number
690654|NCT01444651|Secondary|Baseline to 3-month Change in Matsuda Disposition Index|Change in disposition index from baseline to 3 months. This index is a composite measure thought to reflect insulin resistance and secretion. Matsuda disposition index = [Matsuda sensitivity index * insulinogenic index]|Baseline and 3 months|||unitless index||Standard Deviation|Mean
690655|NCT01444651|Secondary|Baseline to 3 Month Change in Composite of Insulin Resistance and Sensitivity, as Measured by the Oral Disposition Index|The secondary endpoint is defined as the treatment group difference in the change in oral disposition index (baseline minus 3-month). This is thought to reflect a composite of both insulin resistance and secretion. Oral disposition index = insulinogenic index / fasting insulin|Baseline and 3 months|||unitless index||Standard Deviation|Mean
690656|NCT01444651|Secondary|Insulinogenic Index|The secondary endpoint is defined as the treatment group difference in the change in insulinogenic index (baseline minus 3-month). This index is thought to reflect insulin secretion, and is derived from fasting and 30 min-post oral glucose tolerance testing glucose and insulin values. Insulinogenic index = [fasting insulin - insulin at time 30 min] / [fasting glucose - glucose at time 30 min]|Baseline and 3 months|||unitless index||Standard Deviation|Mean
690657|NCT01444651|Secondary|Baseline to 3-month Change in Endothelial Function Measured by EndoPAT|Endothelial function was measured using the reactive hyperemia index, acquired using EndoPAT device. Peripheral arterial tonometry probes were placed on both index fingers. After a 5 min equilibration period, a blood pressure cuff was inflated to 200 mmHg and kept inflated for 5 min. The cuff was then rapidly deflated and the reactive hyperemic response pulse volume recorded, where RHI = ratio of hyperemic finger pulse volume (post-cuff inflation / pre-cuff inflation) to control finger pulse volume (post-cuff inflation / pre-cuff inflation)|Baseline and 3 months|||unitless index||Standard Deviation|Mean
690658|NCT01444651|Secondary|Baseline to 3-month Change in Insulin Sensitivity, as Measured by the Matsuda Index|The secondary endpoint is defined as the treatment group difference in the change in Matsuda Index (baseline minus 3-month). This index is a measure of insulin resistance derived from a frequently sampled oral glucose tolerance test, obtaining glucose and insulin levels in the fasting state, as well as 30, 60, 90, and 120 min after administration of oral glucose load. Matsuda index = 10,000/SQRT [fasting glucose*fasting insulin* (mean glucose from time 30, 60, 90, 120 min) * (mean insulin at time 30, 60, 90, and 120 min)]|Baseline and 3 months|||unitless index||Standard Deviation|Mean
690661|NCT01444456|Secondary|Percentage of Participants With Improvement in Patient-perceived Fatigue (PPF) at Any Time|The percentage of participants with iimprovement in PPF at any time from Day 2 until the end-of-study assessment (Week 13). Improvement in PPF was defined as improvement in Functional Assessment of Cancer Therapy-Fatigue (FACT-F) score of ≥ 3.5 points from Baseline (the minimally important difference [MID]). The FACT-F MID was determined by the mean FACT-F change score (between Baseline and Week 9) for participants who had an improvement in the fatigue visual analog scale (VAS) score of 5 ± 3 points. The FACT-F subscale consists of 13 fatigue-related items that are a subset of the FACT-An questionnaire. Participants indicate how they feel in response to 13 statements on a scale from 0 for “Not at all” to 4 for “Very much”. Total scores for the FACT-F subscale range from 0 to 52; the higher the score the better the quality of life. The fatigue-VAS is a 100-point scale, where fatigue-levels are rated from 0 (least fatigue) to 100 (worst possible fatigue).|From Baseline to Week 13|Primary analysis set||percentage of participants|||Number
690662|NCT01444456|Secondary|Time to First Increase in Hemoglobin|Time from Baseline to first increase in hemoglobin of ≥ 1 g/dL|From Baseline until Week 9|Primary analysis set||days||95% Confidence Interval|Median
690663|NCT01444456|Secondary|Mean Change From Baseline in FACT-F Score for Participants With a VAS Improvement of 5 ± 3 Points|The FACT-F subscale consists of 13 fatigue-related items (statements) that are a subset of the Functional Assessment of Cancer Therapy - Anaemia (FACT-An) questionnaire. Participants are asked to indicate how they feel in response to each of the 13 statements on a scale from 0 for “Not at all” to 4 for “Very much”. Total scores for the FACT-F subscale can range from 0 to 52; the higher the score the better the quality of life. A positive change (>0) from baseline score constitutes an improvement in fatigue between Baseline and Week 9. The fatigue-visual analog scale (VAS) is a 100-point scale where fatigue-levels are rated from 0 (least fatigue) to 100 (worst possible fatigue).|Baseline and Week 9|Primary analysis set participants with a fatigue VAS score improvement at Week 9 of 5 ± 3 points from Baseline||units on a scale||Standard Deviation|Mean
690664|NCT01444456|Secondary|Percentage of Participants by Tumor Type With Improvement in Patient Perceived Fatigue (PPF) and Increase in Hemoglobin ≥ 1 g/dL|Improvement in PPF was defined as improvement at week 9 in Functional Assessment of Cancer Therapy-Fatigue (FACT-F) score of ≥ 3.5 points from Baseline (the minimally important difference [MID]), and an increase in hemoglobin was defined as ≥ 1 g/dL increase from Baseline. The FACT-F MID was determined by the mean FACT-F change score (between Baseline and Week 9) for participants who had an improvement in the fatigue visual analog scale (VAS) score of 5 ± 3 points. The FACT-F subscale consists of 13 fatigue-related items that are a subset of the Functional Assessment of Cancer Therapy - Anaemia (FACT-An) questionnaire. Participants indicate how they feel in response to 13 statements on a scale from 0 for “Not at all” to 4 for “Very much”. Total scores for the FACT-F subscale range from 0 to 52; the higher the score the better the quality of life. The fatigue-VAS is a 100-point scale, where fatigue-levels are rated from 0 (least fatigue) to 100 (worst possible fatigue).|Baseline to Week 9|Primary analysis set||percentage of participants||95% Confidence Interval|Number
690665|NCT01444456|Primary|Percentage of Participants Receiving Darbepoetin Alfa With Improvement in Patient Perceived Fatigue (PPF) and Increase in Hemoglobin ≥ 1 g/dL|Improvement in PPF was defined as improvement at Week 9 in Functional Assessment of Cancer Therapy-Fatigue (FACT-F) score of ≥ 3.5 points from Baseline (the minimally important difference [MID]), and an increase in hemoglobin was defined as ≥ 1 g/dL increase from Baseline. The FACT-F MID was determined by the mean FACT-F change score (between Baseline and Week 9) for participants who had an improvement in the fatigue visual analog scale (VAS) score of 5 ± 3 points. The FACT-F subscale consists of 13 fatigue-related items that are a subset of the Functional Assessment of Cancer Therapy - Anaemia (FACT-An) questionnaire. Participants indicate how they feel in response to 13 statements on a scale from 0 for “Not at all” to 4 for “Very much”. Total scores for the FACT-F subscale range from 0 to 52; the higher the score the better the quality of life. The fatigue-VAS is a 100-point scale, where fatigue-levels are rated from 0 (least fatigue) to 100 (worst possible fatigue).|Baseline to Week 9 (Treatment Day 57). Due to the observational nature of the study and variation in ESA dosing schedules, assessments closest to day 57 and within Days 43 to 70 (inclusive) were used to calculate the Week 9 visit results.|The Primary analysis set consists of enrolled participants who received at least 1 dose of darbepoetin alfa, have baseline assessments for each of Hemoglobin, FACT-F subscale and VAS, and analyzable post-baseline assessments for each of Hemoglobin, FACT-F subscale, and VAS at Week 9.||percentage of participants||95% Confidence Interval|Number
690666|NCT01444430|Secondary|Number of Participants Experiencing Discontinuation of Investigational Product Due to a Protocol Defined Asthma Exacerbation|Number of participants experiencing discontinuation of investigational product due to a protocol defined asthma exacerbation. An asthma exacerbation was defined as a deterioration of asthma requiring systemic corticosteroids for at least 3 days or an inpatient hospitalization or emergency room visit due to asthma that required systemic corticosteroids. Cox proportional hazards model with terms for randomized treatment and strata for incoming control/asthma treatment was used to compare Symbicort and budesonide. Hazard ratios and 95% confidence intervals were estimated.|Up to 26 weeks|The On treatment Analysis set comprised of all randomized patients and included data that corresponded to each patient’s period of exposure to study drug plus 7 days after the last date of study drug treatment.||Participants|||Number
690667|NCT01444430|Secondary|Percent of Nights With Awakening(s) Due to Asthma|Percent of nights with awakening(s) due to asthma during the randomized treatment period. Analysis of variance (ANOVA) model including the fixed factors of treatment and strata by incoming control/asthma treatment was used to compare Symbicort and budesonide.|Daily up to 26 weeks|Full analysis set (FAS) population comprised of all patients randomized to study drug and had at least one entry of diary data after randomization.||Percentage of nights||Standard Error|Least Squares Mean
690679|NCT01444417|Primary|Percentage of Participants With a Durable Platelet Response|A participant with durable platelet response was defined as achieving at least 6 weekly platelet counts of ≥ 50 x 10^9/L during the last 8 weeks of treatment (platelet counts obtained from week 18 to week 25). If a platelet count from a participant was not available (missing) in a certain week, that week was imputed as non-response for that participant. Platelet counts were not deemed as a positive response for 4 weeks after the administration of rescue medication.|Week 18 to week 25|Efficacy analysis set (all randomized participants)||percentage of participants||95% Confidence Interval|Number
695712|NCT01386632|Secondary|Overall Survival for Locally Advanced Head and Neck Squamous Cell Carcinoma Patients Receiving Concurrent Cisplatin, Radiation Therapy, and DCA.||1 year||||||
690668|NCT01444430|Secondary|Asthma Control Questionnaire (ACQ6)|"The outcome variable for ACQ6 was the difference between the average of values recorded during the treatment period (day 28, day 84 and day 182) and the baseline measure. Analysis of covariance (ANCOVA) model, including the fixed factors of treatment and strata by incoming control/asthma treatment and baseline ACQ6 as covariate was used to compare Symbicort and budesonide.
The asthma control questionnaire, ACQ6, consists of six questions; all assessed on a 7-point scale from 0 to 6, where 0 represents good control and 6 represents poor control. The overall score is the mean of the responses to each of the six questions."|baseline, day 28, day 84, day 182|Full analysis set (FAS) population comprised of all patients randomized to study drug with at least one post-baseline ACQ6 score.||ACQ6 overall score change from baseline||Standard Error|Least Squares Mean
690669|NCT01444430|Secondary|Mean Number of Puffs of Rescue Medication Per 24 Hours|Mean number of puffs of rescue medication per day (24 hours) during the randomized treatment period. Analysis of variance (ANOVA) model including the fixed factors of treatment and strata by incoming control/asthma treatment was used to compare Symbicort and budesonide.|Daily up to 26 weeks|Full analysis set (FAS) population comprised of all patients randomized to study drug and had at least one entry of diary data after randomization.||Inhalations/day||Standard Error|Least Squares Mean
690670|NCT01444430|Secondary|Percent of Days With Activity Limitation Due to Asthma|Percent of days with activity limitation due to asthma during the randomized treatment period. Analysis of variance (ANOVA) model including the fixed factors of treatment and strata by incoming control/asthma treatment was used to compare Symbicort and budesonide.|Daily up to 26 weeks|Full analysis set (FAS) population comprised of all patients randomized to study drug. The analysis set comprises of all patients with at least one day with asthma symptoms, i.e. the denominator is the number of days with asthma symptoms.||Percentage of days||Standard Error|Least Squares Mean
690671|NCT01444430|Secondary|Percent of Days With no Asthma Symptoms|Percent of days with no asthma symptoms during the randomized treatment period. Analysis of variance (ANOVA) model including the fixed factors of treatment and strata by incoming control/asthma treatment was used to compare Symbicort and budesonide.|Daily up to 26 weeks|Full analysis set (FAS) population comprised of all patients randomized to study drug and had at least one entry of diary data after randomization.||Percentage of days||Standard Error|Least Squares Mean
690672|NCT01444430|Primary|Number of Participants Experiencing an Event Included in the Definition of Asthma Exacerbation|Number of participants experiencing an event included in the definition of asthma exacerbation. An asthma exacerbation was defined as a deterioration of asthma requiring systemic corticosteroids for at least 3 days or an inpatient hospitalization or emergency room visit due to asthma that required systemic corticosteroids. Cox proportional hazards model with terms for randomized treatment and strata for incoming control/asthma treatment was used to compare Symbicort and budesonide. Hazard ratios and 95% confidence intervals were estimated.|Up to 26 weeks|The On treatment Analysis set comprised of all randomized patients and included data that corresponded to each patient’s period of exposure to study drug plus 7 days after the last date of study drug treatment.||Participants|||Number
690673|NCT01444430|Primary|Number of Participants Experiencing an Event in the Composite Endpoint (Asthma-related Death, Asthma-related Intubation or Asthma-related Hospitalization)|Number of participants experiencing an event in the composite endpoint (asthma-related death, asthma-related intubation or asthma-related hospitalization), using events adjudicated and confirmed by the Joint Adjudication Committee. Cox proportional hazards model with terms for randomized treatment and strata for incoming control/asthma treatment was used to compare Symbicort and budesonide. Hazard ratios and 95% confidence intervals were estimated.|Up to 27 weeks|Full analysis set (FAS) population comprised of all patients randomized to study drug.||Participants|||Number
690674|NCT01444417|Secondary|Number of Participants With Adverse Events|"A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria:
fatal,
life threatening (places the subject at immediate risk of death),
requires in-patient hospitalization or prolongation of existing hospitalization,
results in persistent or significant disability/incapacity,
congenital anomaly/birth defect, and/or
other significant medical hazard. Adverse events were graded for severity according to the CTCAE version 3.0 grading scale, where Grade 3 = moderate, Grade 4 = life-threatening and Grade 5 = fatal.
Treatment-related adverse events (TRAEs) were those assessed by the investigator as possibly related to study drug. This relationship was determined by a “yes” or “no” response to the question: “Is there a reasonable possibility that the event may have been caused by study drug?”"|From the first dose of study drug until 4 weeks after last dose; 28 weeks.|Safety analysis set (all participants who received at least one dose of study drug)||participants|||Number
690675|NCT01444417|Secondary|Total Number of Composite Bleeding Episodes|A composite bleeding episode was defined as clinically significant bleeding events or the use of a rescue medication to prevent a clinical significant bleeding event during weeks 2 through 25 of the treatment period. A clinically significant bleeding event was defined as a Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 grade ≥ 2 bleeding event.|Week 2 to week 25|Efficacy analysis set||bleeding episodes||Standard Deviation|Mean
690676|NCT01444417|Secondary|Percentage of Participants Who Received Rescue Medication During the Treatment Period|Rescue medication is any medication (other than excluded medications) that is intended to increase platelet counts or prevent bleeding.|24 weeks|Efficacy analysis set||percentage of participants||95% Confidence Interval|Number
690677|NCT01444417|Secondary|Number of Weeks With Platelet Response|Number of weeks with platelet counts ≥ 50 x 10^9/L during week 2 to week 25 measurements. Participants may not have had a weekly response within 4 weeks after receiving any rescue medications.|Week 2 to week 25|Efficacy analysis set||weeks||Full Range|Median
690678|NCT01444417|Secondary|Percentage of Participants With an Overall Platelet Response|"Overall platelet response is defined as either a durable platelet response or transient platelet response.
Durable platelet response was defined as weekly platelet count ≥ 50 x 10^9/L for 6 or more times during week 18 to week 25 measurements. Participants may not have had a weekly response within 4 weeks after receiving any rescue medication.
Transient platelet response was defined as weekly platelet count ≥ 50 x 10^9/L for 4 or more times during week 2 to week 25 measurements but without durable platelet response. Participants may not have had a weekly response within 4 weeks after receiving any rescue medications."|Week 2 to week 25|Efficacy analysis set||percentage of participants||95% Confidence Interval|Number
695713|NCT01386632|Secondary|Local Response Rate for Locally Advanced Head and Neck Squamous Cell Carcinoma Patients Receiving Concurrent Cisplatin, Radiation Therapy, and DCA.||1 year||||||
690680|NCT01444391|Secondary|Tube Retention|Tube retention is the presence of a tympanostomy tube placed successfully by the Tula TDS device across the tympanic membrane at the two-week follow-up visit.|2 weeks post-procedure|"This outcome measure analysis includes evaluation only of ears with TDS-placed tube.
Two subjects (3 ears) were excluded due to missing follow-up data. An additional 3 subjects (4 ears) were excluded because no TDS tube was placed. Three of the 37 participants analyzed had one of two study ears excluded, due to no TDS in that ear."||ears|Participants||Number
690681|NCT01444391|Secondary|Procedure Tolerability|Procedure Tolerability is defined as the proportion of subjects reporting the procedure as tolerable, where tolerable is defined as a score of 0 through 3, using the Wong-Baker FACES pain scale.The Wong-Baker FACES pain scoring system is a scale of 0 to 5, where 0 means 'no hurt', 1 = 'hurts a little bit', 2 = 'hurts little more', 3 = 'hurts even more', 4 = 'hurts whole lot' and 5 = 'hurts worst'. Procedure Tolerability will be determined on a per patient basis, with the patient’s score being the average of the scores for the left and right ear if both ears are successfully treated with the Tube Delivery System.|Day 0 (day of procedure)|The analysis population includes subjects with successful tube placement using the Tube Delivery System (TDS) in one or both ears. Six subjects were excluded for whom one ear had a successful TDS placement and one ear did not.||participants|||Number
690682|NCT01444391|Secondary|Procedure Success|Procedure Success is defined as the successful placement of any tympanostomy tube in all enrolled ears in a given subject. Procedure Success is determined on a per subject basis.|Day 0 (day of procedure)|||participants|||Number
690683|NCT01444391|Primary|Device Success|Device Success is defined as the successful delivery of the tympanostomy tube (TT) across the tympanic membrane (TM) using the Tube Delivery System(TDS). Device Success will be evaluated on a per device basis.|Day 0 (day of procedure)|||devices|Participants||Number
690684|NCT01444391|Primary|Number of Subjects With Procedural, Serious and Device-related Adverse Events.|Adverse events which are procedural, serious, and device-related.|Procedure through 2 weeks post-procedure|||subjects|||Number
690685|NCT01444378|Secondary|Vascular Quality of Life (VascuQol) Total Scores|Vascular Quality of Life (VascuQol) : A standardized, validated questionnaire used to evaluate vascular disease-specific health outcomes. VascuQol total score includes scores of Activity Domain, Symptom Domain, Pain Domain, Emotional Domain and Social Domain. Each item is rated as a 7 point response scale, with a score of 1 being the worst and a score of 7 the best possible. The total average score is the sum of all 25 items scores divided by 25. For each separate domain an average score can be calculated (sum of all items of one domain divided by the number of items of that domain). The highest score for each domain is 7, which indicates best health outcome. There are no sub scales.|1 year|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||score on a scale||Standard Deviation|Mean
690686|NCT01444378|Secondary|Vascular Quality of Life (VascuQol) Total Scores|Vascular Quality of Life (VascuQol) : A standardized, validated questionnaire used to evaluate vascular disease-specific health outcomes. VascuQol total score includes scores of Activity Domain, Symptom Domain, Pain Domain, Emotional Domain and Social Domain. Each item is rated as a 7 point response scale, with a score of 1 being the worst and a score of 7 the best possible. The total average score is the sum of all 25 items scores divided by 25. For each separate domain an average score can be calculated (sum of all items of one domain divided by the number of items of that domain). The highest score for each domain is 7, which indicates best health outcome. There are no sub scales.|6 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||score on a scale||Standard Deviation|Mean
690687|NCT01444378|Secondary|Vascular Quality of Life (VascuQol) Total Scores|"Vascular Quality of Life (VascuQol) : A standardized, validated questionnaire used to evaluate vascular disease-specific health outcomes. VascuQol total score includes scores of Activity Domain, Symptom Domain, Pain Domain, Emotional Domain and Social Domain. Each item is rated as a 7 point response scale, with a score of 1 being the worst and a score of 7 the best possible. The total average score is the sum of all 25 items scores divided by 25. For each separate domain an average score can be calculated (sum of all items of one domain divided by the number of items of that domain). The highest score for each domain is 7, which indicates best health outcome.
There are no sub scales."|1 month|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||score on a scale||Standard Deviation|Mean
690688|NCT01444378|Secondary|Quality of Life Measures : Mental Component Summary (MCS)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|1 year|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||score on a scale||Standard Deviation|Mean
690689|NCT01444378|Secondary|Quality of Life Measures : Mental Component Summary (MCS)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|6 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||score on a scale||Standard Deviation|Mean
690690|NCT01444378|Secondary|Quality of Life Measures : Mental Component Summary (MCS)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|1 month|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||score on a scale||Standard Deviation|Mean
690691|NCT01444378|Secondary|Quality of Life Measures : Physical Component Summary (PCS)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|1 year|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||score on a scale||Standard Deviation|Mean
695714|NCT01386632|Secondary|Local Response Rate for Locally Advanced Head and Neck Squamous Cell Carcinoma Patients Receiving Concurrent Cisplatin, Radiation Therapy, and DCA.||3 months||||||
690693|NCT01444378|Secondary|Quality of Life Measures : Physical Component Summary (PCS)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|1 month|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||score on a scale||Standard Deviation|Mean
690694|NCT01444378|Secondary|Quality of Life Measures : Mental Health (MH)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|1 year|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||score on a scale||Standard Deviation|Mean
690695|NCT01444378|Secondary|Quality of Life Measures : Mental Health (MH)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|6 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||score on a scale||Standard Deviation|Mean
690696|NCT01444378|Secondary|Quality of Life Measures : Mental Health (MH)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|1 month|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||score on a scale||Standard Deviation|Mean
690697|NCT01444378|Secondary|Quality of Life Measures : Role Emotional (RE)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|1 year|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||score on a scale||Standard Deviation|Mean
690698|NCT01444378|Secondary|Quality of Life Measures : Role Emotional (RE)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|6 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||score on a scale||Standard Deviation|Mean
690699|NCT01444378|Secondary|Quality of Life Measures : Role Emotional (RE)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|1 month|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||score on a scale||Standard Deviation|Mean
690700|NCT01444378|Secondary|Quality of Life Measures : Social Functioning (SF)|"SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
rm-Based Scores."|1 year|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||score on a scale||Standard Deviation|Mean
690701|NCT01444378|Secondary|Quality of Life Measures : Social Functioning (SF)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|6 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||score on a scale||Standard Deviation|Mean
690702|NCT01444378|Secondary|Quality of Life Measures : Social Functioning (SF)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|1 month|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||score on a scale||Standard Deviation|Mean
690703|NCT01444378|Secondary|Quality of Life Measures : Vitality (VT)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|1 year|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||score on a scale||Standard Deviation|Mean
690704|NCT01444378|Secondary|Quality of Life Measures : Vitality (VT)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|6 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||score on a scale||Standard Deviation|Mean
690705|NCT01444378|Secondary|Quality of Life Measures : Vitality (VT)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|1 month|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||score on a scale||Standard Deviation|Mean
690706|NCT01444378|Secondary|Quality of Life Measures : General Health (GH)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|1 year|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||score on a scale||Standard Deviation|Mean
690707|NCT01444378|Secondary|Quality of Life Measures : General Health (GH)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|6 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||score on a scale||Standard Deviation|Mean
690708|NCT01444378|Secondary|Quality of Life Measures : General Health (GH)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|1 month|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||score on a scale||Standard Deviation|Mean
690709|NCT01444378|Secondary|Quality of Life Measures : Bodily Pain (BP)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|1 year|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||score on a scale||Standard Deviation|Mean
690710|NCT01444378|Secondary|Quality of Life Measures : Bodily Pain (BP)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|6 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||score on a scale||Standard Deviation|Mean
690711|NCT01444378|Secondary|Quality of Life Measures : Bodily Pain (BP)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|1 month|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||score on a scale||Standard Deviation|Mean
690712|NCT01444378|Secondary|Quality of Life Measures : Role Physical (RP)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|1 year|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||score on a scale||Standard Deviation|Mean
690713|NCT01444378|Secondary|Quality of Life Measures : Role Physical (RP)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|6 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||score on a scale||Standard Deviation|Mean
690714|NCT01444378|Secondary|Quality of Life Measures : Role Physical (RP)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|1 month|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||score on a scale||Standard Deviation|Mean
690715|NCT01444378|Secondary|Quality of Life Measures : Physical Functioning (PF)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|1 year|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||score on a scale||Standard Deviation|Mean
690716|NCT01444378|Secondary|Quality of Life Measures : Physical Functioning (PF)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|6 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||score on a scale||Standard Deviation|Mean
690717|NCT01444378|Secondary|Quality of Life Measures : Physical Functioning (PF)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|1 month|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||score on a scale||Standard Deviation|Mean
690718|NCT01444378|Secondary|Freedom From Ipsilateral Major Amputation|Amputation is defined as the removal of a body extremity by surgery. For this trial, the definition of amputation will only include amputations of the limb that was treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.|0 to 379 days|ITT population. This analysis represents those subjects who were event free at this time point.||percentage of participants|||Number
690719|NCT01444378|Secondary|Freedom From Ipsilateral Major Amputation|Amputation is defined as the removal of a body extremity by surgery. For this trial, the definition of amputation will only include amputations of the limb that was treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.|0 to 365 days|ITT population. This analysis represents those subjects who were event free at this time point.||percentage of participants|||Number
690720|NCT01444378|Secondary|Freedom From Ipsilateral Major Amputation|Amputation is defined as the removal of a body extremity by surgery. For this trial, the definition of amputation will only include amputations of the limb that was treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.|0 to 180 days|ITT population. This analysis represents those subjects who were event free at this time point.||percentage of participants|||Number
690721|NCT01444378|Secondary|Freedom From Ipsilateral Major Amputation|Amputation is defined as the removal of a body extremity by surgery. For this trial, the definition of amputation will only include amputations of the limb that was treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.|0 to 30 days|ITT population. This analysis represents those subjects who were event free at this time point.||percentage of participants|||Number
690722|NCT01444378|Secondary|Freedom From Ipsilateral Major Amputation|Amputation is defined as the removal of a body extremity by surgery. For this trial, the definition of amputation will only include amputations of the limb that was treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.|At day 0 (on the day of index procedure)|ITT population. This analysis represents those subjects who were event free at this time point.||percentage of participants|||Number
690723|NCT01444378|Secondary|In-Stent Percent Diameter Stenosis (%DS)|"Percent Diameter Stenosis:
The value calculated as 100 * (1 - Minimum Lumen Diameter/Reference Vessel Diameter) using the mean values from two orthogonal views (when possible) by Quantitative Analysis."|Post-Procedure (≥ 1 day)|ITT population, per lesion analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||Percent Diameter stenosis||Standard Deviation|Mean
690724|NCT01444378|Secondary|In-Segment Percent Diameter Stenosis (%DS)|"Percent Diameter Stenosis:
The value calculated as 100 * (1 - Minimum Lumen Diameter/Reference Vessel Diameter) using the mean values from two orthogonal views (when possible) by Quantitative Analysis."|Post-Procedure (≥ 1 day)|ITT population, per lesion analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||Percent Diameter stenosis|Target lesions|Standard Deviation|Mean
690725|NCT01444378|Secondary|In-Segment Percent Diameter Stenosis (%DS)|"Percent Diameter Stenosis:
The value calculated as 100 * (1 - Minimum Lumen Diameter/Reference Vessel Diameter) using the mean values from two orthogonal views (when possible) by Quantitative Analysis."|Pre-Procedure|ITT population, per lesion analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||Percent Diameter stenosis|Target lesions|Standard Deviation|Mean
690726|NCT01444378|Secondary|Stent Occlusion|Stent occlusion was defined as total occlusion identified within the stent by arteriography and/or ultrasound that occurs > 30 days post-index procedure.|> 30 Days Post Study Procedure|ITT population.||percentage of participants|||Number
690727|NCT01444378|Secondary|Sub-Acute Stent Thrombosis|Stent thrombosis was defined as total occlusion identified within the stent by arteriography and/or ultrasound that occurs within 30 days post-index procedure.|> 24 Hours – 30 Days Post Study Procedure|ITT population.||percentage of participants|||Number
690728|NCT01444378|Secondary|Acute Stent Thrombosis|Stent thrombosis was defined as total occlusion identified within the stent by arteriography and/or ultrasound that occurs within 30 days post-index procedure.|0 - 24 Hours Post Study Procedure|ITT population.||percentage of participants|||Number
690729|NCT01444378|Secondary|Duplex Ultrasound: In-Stent Peak Systolic Velocity Ratio (PSVR)|In-Stent Restenosis: Re-narrowing within the margins of the stent following the reduction of a previous narrowing. It is defined as the presence of a hemodynamically significant restenosis (≥ 50%), as determined by duplex ultrasound or arteriography. A PSVR of > 2.4 will be used to determine restenosis via duplex ultrasound.|12 months|ITT population, per lesion analysis. In-stent peak systolic velocity (PSV) and in-stent peak systolic velocity ratio (PSVR) are excluded from the analysis, for subjects who had TLR prior to the duplex ultrasound or duplex ultrasound was out of the protocol defined window or duplex ultrasound was not readable.||cm/sec|Target lesions|Standard Deviation|Mean
690730|NCT01444378|Secondary|Duplex Ultrasound: In-Stent Peak Systolic Velocity Ratio (PSVR)|In-Stent Restenosis: Re-narrowing within the margins of the stent following the reduction of a previous narrowing. It is defined as the presence of a hemodynamically significant restenosis (≥ 50%), as determined by duplex ultrasound or arteriography. A PSVR of > 2.4 will be used to determine restenosis via duplex ultrasound.|1 month|ITT population, per lesion analysis. In-stent peak systolic velocity (PSV) and in-stent peak systolic velocity ratio (PSVR) are excluded from the analysis, for subjects who had TLR prior to the duplex ultrasound or duplex ultrasound was out of the protocol defined window or duplex ultrasound was not readable.||cm/sec|Target lesions|Standard Deviation|Mean
690731|NCT01444378|Secondary|Duplex Ultrasound: Maximum In-Stent Peak Systolic Velocity (PSV)|"In-Stent Restenosis:
Re-narrowing within the margins of the stent following the reduction of a previous narrowing. It is defined as the presence of a hemodynamically significant restenosis (≥ 50%), as determined by duplex ultrasound or arteriography."|12 months|ITT population, per lesion analysis. In-stent peak systolic velocity (PSV) and in-stent peak systolic velocity ratio (PSVR) are excluded from the analysis, for subjects who had TLR prior to the duplex ultrasound or duplex ultrasound was out of the protocol defined window or duplex ultrasound was not readable.||cm/sec|Target lesions|Standard Deviation|Mean
690732|NCT01444378|Secondary|Duplex Ultrasound: Maximum In-Stent Peak Systolic Velocity (PSV)|"In-Stent Restenosis:
Re-narrowing within the margins of the stent following the reduction of a previous narrowing. It is defined as the presence of a hemodynamically significant restenosis (≥ 50%), as determined by duplex ultrasound or arteriography."|1 month|ITT population, per lesion analysis. In-stent peak systolic velocity (PSV) and in-stent peak systolic velocity ratio (PSVR) are excluded from the analysis, for subjects who had TLR prior to the duplex ultrasound or duplex ultrasound was out of the protocol defined window or duplex ultrasound was not readable.||cm/sec|Target lesions|Standard Deviation|Mean
690733|NCT01444378|Secondary|Toe Brachial Index (TBI)|The toe brachial index is the ratio of the resting ipsilateral toe systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.|At 1 year|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||ratio||Standard Deviation|Mean
690734|NCT01444378|Secondary|Toe Brachial Index (TBI)|The toe brachial index is the ratio of the resting ipsilateral toe systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.|At 6 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||ratio||Standard Deviation|Mean
691871|NCT01435031|Secondary|Target Lesion Failure (TLF)|Composite of cardiac death, target vessel-related MI, and clinically-driven TLR|2 years|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||Participants|||Count of Participants
690735|NCT01444378|Secondary|Toe Brachial Index (TBI)|The toe brachial index is the ratio of the resting ipsilateral toe systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.|At 1 month|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||ratio||Standard Deviation|Mean
690736|NCT01444378|Secondary|Stent Integrity by X-ray|"Xrays were performed to evaluate stent integrity and to determine the presence of any stent fractures.
Grade of fracture as follows:
0 - No stent fracture(s) identified
- Single strut fracture only
- Multiple strut fractures
- Stent fracture with alignment
- Fracture out of alignment (≥ 2 segments)
- Spiral Fracture"|12 months|ITT population.||percentage of participants|||Number
690737|NCT01444378|Secondary|Maximum Walking Distance||12 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||percentage of participants|||Number
690738|NCT01444378|Secondary|Maximum Walking Distance||6 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||percentage of participants|||Number
690739|NCT01444378|Secondary|Maximum Walking Distance||1 month|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||percentage of participants|||Number
690740|NCT01444378|Secondary|Maximum Walking Distance||Pre-procedure|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||percentage of participants|||Number
690741|NCT01444378|Secondary|Walking Impairment Questionnaire Scores|Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.|12 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||scores on a scale||Standard Deviation|Mean
690742|NCT01444378|Secondary|Walking Impairment Questionnaire Scores|Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.|6 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||scores on a scale||Standard Deviation|Mean
690743|NCT01444378|Secondary|Walking Impairment Questionnaire Scores|Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.|1 month|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||scores on a scale||Standard Deviation|Mean
690744|NCT01444378|Secondary|Walking Impairment Questionnaire Scores|Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.|Pre-procedure|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||scores on a scale||Standard Deviation|Mean
690745|NCT01444378|Secondary|Rutherford-Becker Clinical Category for the Treated Limb|"The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.
Category and Clinical Description:
0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable."|12 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||percentage of participants|||Number
690746|NCT01444378|Secondary|Rutherford-Becker Clinical Category for the Treated Limb|"The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.
Category and Clinical Description:
0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable."|6 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||percentage of participants|||Number
690766|NCT01444378|Secondary|Target Vessel Revascularization (TVR)|TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the ipsilateral superficial femoral artery and the proximal popliteal artery, including the target lesion itself.|At 1 month|ITT population, per subject analysis.||percentage of participants|||Number
690747|NCT01444378|Secondary|Rutherford-Becker Clinical Category for the Treated Limb|"The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.
Category and Clinical Description:
0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable."|1 month|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||percentage of participants|||Number
690748|NCT01444378|Secondary|Rutherford-Becker Clinical Category for the Treated Limb|"The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.
Category and Clinical Description:
0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable."|Pre-procedure|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||percentage of participants|||Number
690749|NCT01444378|Secondary|Embolic Events in the Treated Limb (as Reported by Site)|Embolic Event is defined as formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery.|At 1 year|ITT population, per subject analysis.||percentage of participants|||Number
690750|NCT01444378|Secondary|Embolic Events in the Treated Limb (as Reported by Site)|Embolic Event is defined as formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery.|At 6 months|ITT population, per subject analysis.||percentage of participants|||Number
690751|NCT01444378|Secondary|Embolic Events in the Treated Limb (as Reported by Site)|Embolic Event is defined as formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery.|At 1 month|ITT population, per subject analysis.||percentage of participants|||Number
690752|NCT01444378|Secondary|Freedom From Any Ipsilateral Amputation|Amputation is defined as the removal of a body extremity by surgery. For this trial, the definition of amputation will only include amputations of the limb that was treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.|0 to 379 days|ITT population. This analysis represents those subjects who were event free at this time point.||percentage of participants|||Number
690753|NCT01444378|Secondary|Freedom From Any Ipsilateral Amputation|Amputation is defined as the removal of a body extremity by surgery. For this trial, the definition of amputation will only include amputations of the limb that was treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.|0 to 365 days|ITT population. This analysis represents those subjects who were event free at this time point.||percentage of participants|||Number
690754|NCT01444378|Secondary|Freedom From Any Ipsilateral Amputation|Amputation is defined as the removal of a body extremity by surgery. For this trial, the definition of amputation will only include amputations of the limb that was treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.|0 to 180 days|ITT population. This analysis represents those subjects who were event free at this time point.||percentage of participants|||Number
690755|NCT01444378|Secondary|Freedom From Any Ipsilateral Amputation|Amputation is defined as the removal of a body extremity by surgery. For this trial, the definition of amputation will only include amputations of the limb that was treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.|0 to 30 days|ITT population. This analysis represents those subjects who were event free at this time point.||percentage of participants|||Number
690756|NCT01444378|Secondary|Freedom From Any Ipsilateral Amputation|Amputation is defined as the removal of a body extremity by surgery. For this trial, the definition of amputation will only include amputations of the limb that was treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.|At day 0 (on the day of index procedure)|ITT population. This analysis represents those subjects who were event free at this time point.||percentage of participants|||Number
690757|NCT01444378|Secondary|Freedom From Stent Patency|Primary Stent Patency defined as < 50% stenosis of the stented segment, as determined by duplex ultrasound or arteriography.|0 to 379 days|ITT population. This analysis represents those subjects who were event free at this time point.||percentage of participants|||Number
690758|NCT01444378|Secondary|Freedom From Stent Patency|Primary Stent Patency defined as < 50% stenosis of the stented segment, as determined by duplex ultrasound or arteriography.|0 to 365 days|ITT population. This analysis represents those subjects who were event free at this time point.||percentage of participants|||Number
690759|NCT01444378|Secondary|Freedom From Stent Patency|Primary Stent Patency defined as < 50% stenosis of the stented segment, as determined by duplex ultrasound or arteriography.|0 to 180 days|ITT population. This analysis represents those subjects who were event free at this time point.||percentage of participants|||Number
690760|NCT01444378|Secondary|Freedom From Stent Patency|Primary Stent Patency defined as < 50% stenosis of the stented segment, as determined by duplex ultrasound or arteriography.|0 to 30 days|ITT population. This analysis represents those subjects who were event free at this time point.||percentage of participants|||Number
690761|NCT01444378|Secondary|Death||At 1 year|ITT population, per subject analysis.||percentage of participants|||Number
690762|NCT01444378|Secondary|Death||At 6 months|ITT population, per subject analysis.||percentage of participants|||Number
690763|NCT01444378|Secondary|Death||At 1 month|ITT population, per subject analysis.||percentage of participants|||Number
690764|NCT01444378|Secondary|Target Vessel Revascularization (TVR)|TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the ipsilateral superficial femoral artery and the proximal popliteal artery, including the target lesion itself.|At 1 year|ITT population, per subject analysis.||percentage of participants|||Number
690765|NCT01444378|Secondary|Target Vessel Revascularization (TVR)|TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the ipsilateral superficial femoral artery and the proximal popliteal artery, including the target lesion itself.|At 6 months|ITT population, per subject analysis.||percentage of participants|||Number
690767|NCT01444378|Secondary|Any Target Lesion Revascularization (TLR)|TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be prospectively classified as clinically-driven or not clinically-driven by the investigator prior to repeat angiography. An independent angiographic core laboratory will verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent.|At 1 year|ITT population, per subject analysis.||percentage of participants|||Number
690768|NCT01444378|Secondary|Any Target Lesion Revascularization (TLR)|TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be prospectively classified as clinically-driven or not clinically-driven by the investigator prior to repeat angiography. An independent angiographic core laboratory will verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent.|At 6 months|ITT population, per subject analysis.||percentage of participants|||Number
690769|NCT01444378|Secondary|Any Target Lesion Revascularization (TLR)|TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be prospectively classified as clinically-driven or not clinically-driven by the investigator prior to repeat angiography. An independent angiographic core laboratory will verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent.|At 1 month|ITT population, per subject analysis.||percentage of participants|||Number
690770|NCT01444378|Secondary|Clinically-driven Target Lesion Revascularization (CD-TLR)|"Revascularization within the borders of the stent, +5 mm unstented vessel at both ends, with diameter stenosis ≥ 50% (determined by duplex ultrasound or angiographic core laboratory) (Note: This does not include coincidental overlap of a percutaneous transluminal angioplasty (PTA) balloon or stent into a study stent, that has <50% stenosis, while treating a non-target lesion in the target vessel) plus one or both of the following:
Worsening Rutherford-Becker Clinical Category;
Change in ABI by >0.15 and ABI ≤0.8"|At 1 year|ITT population, per subject analysis.||percentage of participants|||Number
690771|NCT01444378|Secondary|Clinically-driven Target Lesion Revascularization (CD-TLR)|"Revascularization within the borders of the stent, +5 mm unstented vessel at both ends, with diameter stenosis ≥ 50% (determined by duplex ultrasound or angiographic core laboratory) (Note: This does not include coincidental overlap of a percutaneous transluminal angioplasty (PTA) balloon or stent into a study stent, that has <50% stenosis, while treating a non-target lesion in the target vessel) plus one or both of the following:
Worsening Rutherford-Becker Clinical Category;
Change in ABI by >0.15 and ABI ≤0.8"|At 6 months|ITT population, per subject analysis.||percentage of participants|||Number
690772|NCT01444378|Secondary|Clinically-driven Target Lesion Revascularization (CD-TLR)|"Revascularization within the borders of the stent, +5 mm unstented vessel at both ends, with diameter stenosis ≥ 50% (determined by duplex ultrasound or angiographic core laboratory) (Note: This does not include coincidental overlap of a percutaneous transluminal angioplasty (PTA) balloon or stent into a study stent, that has <50% stenosis, while treating a non-target lesion in the target vessel) plus one or both of the following:
Worsening Rutherford-Becker Clinical Category;
Change in ABI by >0.15 and ABI ≤0.8"|At 1 month|ITT population, per subject analysis.||percentage of participants|||Number
690773|NCT01444378|Secondary|Ankle Brachial Index (ABI) for the Treated Limb|"A measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms.
ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure. The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease.
A value greater than 1.3 is considered abnormal suggesting calcification of the walls of the arteries and noncompressible vessels, reflecting severe peripheral vascular disease. For patients in whom the ABI cannot be accurately measured , toe pressure measurement and toe brachial index should be used."|12 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point. ABI > 1.3 was excluded from the analysis.||Ratio||Standard Deviation|Mean
690774|NCT01444378|Secondary|Ankle Brachial Index (ABI) for the Treated Limb|"A measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms.
ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure. The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease.
A value greater than 1.3 is considered abnormal suggesting calcification of the walls of the arteries and noncompressible vessels, reflecting severe peripheral vascular disease. For patients in whom the ABI cannot be accurately measured , toe pressure measurement and toe brachial index should be used."|6 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point. ABI > 1.3 was excluded from the analysis.||Ratio||Standard Deviation|Mean
690788|NCT01444287|Primary|Limbal Redness|Scale of 0 to 4, where 0=none and 4= severe redness. Measure reported as a comparison of 8 hours of wear to baseline with the difference being reported.|Baseline, After 8 hours of treatment conditions|||units on a scale||Standard Error|Least Squares Mean
690789|NCT01444287|Primary|Endothelial Blebs|Corneal images captured with equipment are measured, manually outlined to estimate total bleb area from 0 to 100%. This is measured as a change in percentage after 20 minutes compared to the value prior to lens wear (baseline).|baseline, after 20 minutes of treatment conditions|||percentage of bleb area||Standard Error|Mean
690775|NCT01444378|Secondary|Ankle Brachial Index (ABI) for the Treated Limb|"A measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms.
ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure. The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease.
A value greater than 1.3 is considered abnormal suggesting calcification of the walls of the arteries and noncompressible vessels, reflecting severe peripheral vascular disease. For patients in whom the ABI cannot be accurately measured , toe pressure measurement and toe brachial index should be used."|1 month|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point. ABI > 1.3 was excluded from the analysis.||Ratio||Standard Deviation|Mean
690776|NCT01444378|Secondary|Ankle Brachial Index (ABI) for the Treated Limb|"A measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms.
ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure. The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease.
A value greater than 1.3 is considered abnormal suggesting calcification of the walls of the arteries and noncompressible vessels, reflecting severe peripheral vascular disease. For patients in whom the ABI cannot be accurately measured , toe pressure measurement and toe brachial index should be used."|Pre-Procedure|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point. ABI > 1.3 was excluded from the analysis.||Ratio||Standard Deviation|Mean
690777|NCT01444378|Secondary|Freedom From Vessel Patency|This is the primary effectiveness endpoint which is defined as the absence of in-stent restenosis (≥ 50%) as determined by duplex ultrasonography or arteriography and without clinically driven TLR. The vessel patency rate was estimated by the Kaplan-Meier method with the standard error estimated using the Greenwood formula.|0 to 180 days|ITT population. This analysis represents those subjects who were event free at this time point.||percentage of participants|||Number
690778|NCT01444378|Secondary|Freedom From Vessel Patency|This is the primary effectiveness endpoint which is defined as the absence of in-stent restenosis (≥ 50%) as determined by duplex ultrasonography or arteriography and without clinically driven TLR. The vessel patency rate was estimated by the Kaplan-Meier method with the standard error estimated using the Greenwood formula.|0 to 30 days|ITT population. This analysis represents those subjects who were event free at this time point.||percentage of participants|||Number
690779|NCT01444378|Secondary|Acute Success : Technical Success|Technical success: Device success plus attainment of final residual stenosis of < 30%|With in 2 days of index post procedure|ITT population, per lesion analysis||percentage of target lesions|Target Lesions||Number
690780|NCT01444378|Secondary|Acute Success : Clinical Success|Clinical success: Defined on a per patient basis, as the attainment of a final residual stenosis of < 30% by core laboratory assessment using the study device(s) and/or any adjunctive device at all intended target lesion(s) without complications within 2 days after the index procedure or at hospital discharge, whichever is sooner.|With in 2 days after index post procedure or at hospital discharge (before 1 month)|ITT population, per subject analysis||percentage of participants|||Number
690781|NCT01444378|Secondary|Acute Success : Device Success|Device success defined on a per device basis, as the achievement of successful delivery and deployment of the trial device at the intended target lesion and successful withdrawal of the delivery catheter.|With in 2 days of index post procedure|ITT population, per device analysis.||percentage of devices|Device||Number
690782|NCT01444378|Primary|Freedom From Vessel Patency|This is the primary effectiveness endpoint which is defined as the absence of in-stent restenosis (≥ 50%) as determined by duplex ultrasonography or arteriography and without clinically driven TLR. The vessel patency rate was estimated by the Kaplan-Meier method with the standard error estimated using the Greenwood formula.|0 to 365 days|Intention-to-treat (ITT) population. This analysis represents those subjects who were event free at this time point.||percentage of participants|||Number
690783|NCT01444378|Primary|Major Adverse Event (MAE)|"Primary safety endpoint is freedom from MAE which is defined as a composite of:
Death due to all causes
Index limb major amputation (at or above the ankle)
Clinically-driven target lesion revascularization (TLR)"|30 days|||percentage of participants|||Number
690784|NCT01444300|Secondary|Change in Timed 25 Foot Walking Speed||Baseline to 12 weeks|||seconds||Standard Deviation|Mean
690785|NCT01444300|Secondary|Change in Activities-specific Balance Confidence (ABC) Questionnaire Scores|The ABC is an 11-point scale and subjects are asked to indicate personal level of confidence in doing specific activities without losing balance or becoming unsteady on a scale from 0% to 100%. The ratings are added (possible range =0 -1600) and divide by 16 to get each subject's ABC score. A high ABC score indicates a high degree of confidence and a low ABC score indicates a low degree of confidence.|Baseline to 12 weeks|||Scores on a scale||Standard Deviation|Mean
690786|NCT01444300|Primary|Change in Automatic Postural Response (APR )Latency|Automatic Postural Response (APR) latencies will be measured by Computerized Dynamic Posturography (CDP). The restoration of balance after an unexpected movement by Computerized Dynamic Posturography relies on automated postural responses in the upper and lower legs, trunk, shoulders, and neck muscles. APR latency is the reaction- time response to movements of the support surface on which the subject stands. These responses typically occur at onset latencies of ~100 milliseconds. In response to a change, both feet-in-place and stepping strategies can be used to recover balance, with the incidence of stepping responses becoming larger as the change magnitude increases voluntary movements in human subjects.|Baseline to 12 weeks|||milliseconds||Standard Deviation|Mean
690787|NCT01444287|Secondary|Overall Comfort|Patient reported subjective comfort of lenses or spectacles (range 0-100, where 100 is best).|after 8 hours|||units on a scale||Standard Error|Least Squares Mean
697096|NCT01370408|Secondary|Complete Control Rate for Nausea & Vomiting|Complete control rate (CC; defined as no emetic episodes, no rescue medication use, and no more than mild nausea)|120 hours|||participants|||Number
690790|NCT01444287|Primary|Corneal Thickness|Percentage of corneal swelling (positive value) or deswelling (negative value) measured with Haag-Streit pachymetry equipment in microns, reported as a percent.|After 8 hours of contact lens wear|Subjects are those enrolled and randomized to a trial arm.||Percent Change||Standard Error|Least Squares Mean
690791|NCT01444092|Secondary|IMPACT 3|IMPACT 3 is a self-administered QoL form. The score ranges from 35 (poor) to 175 (best).|Baseline to 8 weeks|Safety analysis set||Units on a scale||Standard Deviation|Mean
690792|NCT01444092|Secondary|PCDAI|Paediatric Crohn’s Disease Activity Index. Range from 0 (best) to 100 (worst).|Baseline to 8 weeks|Full analysis set||Units on a scale||Standard Deviation|Mean
690793|NCT01444092|Primary|Adverse Event|Number of patients with at least one adverse event|12 weeks|Safety analysis set||Patients|||Number
690794|NCT01443923|Secondary|Efficacy (SVR) Rates as Predicted by Viral Response at the End of the 4-week lead-in Therapy With PEG/RBV and Comparison Between HCV Monoinfected and HIV/HCV Coinfected Subjects||6 months post treatment|Due to the change in the standard of care treatment of HCV, it became difficult to recruit patients to receive IFN based therapy with the prospects of IFN free treatment being available sooner. Study was prematurely terminated and no data was collected/analyzed for the Outcome.|||||
690795|NCT01443923|Secondary|Proportion of Subjects Who Are Receiving HAART Who Remain With an HIV RNA & lt; 400 Copies/mL and Those With HIV RNA & gt; 400 Copies/mL at End of Treatment||End of Treatment|Due to the change in the standard of care treatment of HCV, it became difficult to recruit patients to receive IFN based therapy with the prospects of IFN free treatment being available sooner. Study was prematurely terminated and no data was collected/analyzed for the Outcome.|||||
690796|NCT01443923|Secondary|Safety and Treatment Outcome Measures Stratified by ESA Use||6 months|Due to the change in the standard of care treatment of HCV, it became difficult to recruit patients to receive IFN based therapy with the prospects of IFN free treatment being available sooner. Study was prematurely terminated and no data was collected/analyzed for the Outcome.|||||
690797|NCT01443923|Secondary|Change in Early HCV Viral Load Kinetics Between Mono and Co-infected Subjects||Day 0, Day 7|Due to the change in the standard of care treatment of HCV, it became difficult to recruit patients to receive IFN based therapy with the prospects of IFN free treatment being available sooner. Study was prematurely terminated and no data was collected/analyzed for the Outcome.|||||
690798|NCT01443923|Primary|Efficacy, Defined as Sustained Viral Response (SVR) Six Months After the End of Specified Treatment.||6 months post treatment|Due to the change in the standard of care treatment of HCV, it became difficult to recruit patients to receive IFN based therapy with the prospects of IFN free treatment being available sooner. Study was prematurely terminated and no data was collected/analyzed for the Outcome.|||||
690799|NCT01443858|Secondary|Percentage of Change of CO at End of Week 3 When Comparing Abstinent Smokers Versus Non-abstinent Smokers|To further validate the association between a decrease in expired air CO before the quit date and subsequent abstinence, the decrease in expired air CO from baseline to week 3 (Session P3) will be compared between abstinent and non-abstinent smokers, using ANOVA.|After 3 weeks of treatment (relative to baseline)|"Abstinent (n=2 Control, 7 25mg, 2 50mg) Non-abstinent (n=16 Control, 16 25mg, 23 50mg)"||percentage change||Standard Error|Mean
690800|NCT01443858|Secondary|Percentage of Change of CO at End of Week 1 When Comparing Abstinent Smokers Versus Non-abstinent Smokers|To further validate the association between a decrease in expired air CO before the quit date and subsequent abstinence, the decrease in expired air CO from baseline to week 1 (Session P2) will be compared between abstinent and non-abstinent smokers, using ANOVA.|After 1 week of treatment (relative to baseline)|"Abstinent (n=2 Control, 7 25mg, 2 50mg) Non-abstinent (n=16 Control, 16 25mg, 23 50mg)"||percentage change||Standard Error|Mean
690801|NCT01443858|Secondary|Number of Participants Completing the Continuous 4 Week Abstinence From Smoking|Continuous 4 week abstinence from smoking (weeks 3-6 post quit date), based on self-reported abstinence confirmed by expired air CO ≤8ppm, will be compared between each meclizine group and placebo, using logistic regression analyses|weeks 3-6 post quit date|||participants||95% Confidence Interval|Number
690802|NCT01443858|Primary|Percentage of Change in Expired Air Carbon Monoxide (CO) at End of Week 3|To evaluate the effects of meclizine as an augmentation treatment in conjunction with nicotine patch, the percent decrease in expired air carbon monoxide (CO) at the end of week 3 (relative to baseline) will be compared (using ANOVA) between each meclizine group and placebo.|After 3 weeks of treatment (relative to baseline)|||percentage change||Standard Error|Mean
690803|NCT01443858|Primary|Percentage of Change in Expired Air Carbon Monoxide (CO) at End of Week 1|To evaluate the effects of meclizine alone on ad lib smoking, the percent decrease in expired air carbon monoxide (CO) at the end of week 1 (relative to baseline) will be compared (using ANOVA) between each meclizine group and placebo.|After 1 week of treatment (relative to baseline)|||percentage change||Standard Error|Mean
690804|NCT01443845|Secondary|Mean Change in Predose Forced Expiratory Volume in 1 Second (FEV1)|Mean change from randomization (Visit 2) over 52 weeks of treatment in predose forced expiratory volume in 1 second (FEV1)|Week 0 (Visit 2) to Week 52|Intent-to-Treat Population who the completed 52-week treatment period||Liters||Standard Error|Least Squares Mean
690805|NCT01443845|Secondary|Rate of Moderate or Severe COPD Exacerbations or COPD Exacerbations Treated With Antibiotics|Rate of moderate or severe COPD exacerbations treated with antibiotics during the double-blind treatment period.|Week 0 (Visit 2) to Week 52|||COPD Exacerbations per Patient per Year||95% Confidence Interval|Number
690806|NCT01443845|Secondary|Rate of COPD Exacerbations That Led to Hospitalization or Death (ie, Severe COPD Exacerbations)|Rate of moderate or severe COPD exacerbations, defined as requiring hospitalization and/or leading to death (severe), during the double-blind treatment period.|Week 0 (Visit 2) to Week 52|Intent-to-Treat Study Population||COPD exacerbations per patient per year||95% Confidence Interval|Number
690807|NCT01443845|Primary|Rate of Moderate or Severe COPD Exacerbations Per Patient Per Year.|Rate of moderate or severe COPD exacerbations, defined as requiring oral or parenteral glucocorticosteroids (moderate) or requiring hospitalization and/or leading to death (severe), during the double-blind treatment period.|Baseline to Week 52|Intent-to-Treat Study Population||COPD exacerbations per patient per year||95% Confidence Interval|Number
690808|NCT01443494|Secondary|Perfused Vessel Density|Increasing MAP from 65 mm Hg to target level. The sublingual microcirculation was measured by sidestream dark field, including the parameters of perfused vessel density|Target MAP stabilization for 30 min|||vessels/mm^2||Standard Deviation|Mean
690809|NCT01443494|Primary|Mean Arterial Pressure|"As chronic hypertensive patients were supposed to have undergone more blood pressure measurements in daily life than non-hypertensive ones, the averaged MAP acquired from patients’ physical examination records of the last two years was registered and assumed as patients’ usual level of MAP and target MAP. If patients’ medical records were incomplete, a detailed enquiry about the target MAP to their next kin was performed.
After stabilization for 30 min, basal measurements including hemodynamic and microcirculatory measurements were taken, 20 min apart, the NE doses were increased to titrate MAP to the target level. Patients were allowed to stabilize for 30 min before taking new measurements."|Target MAP stabilization for 30 min|||mmHg||Standard Deviation|Mean
690810|NCT01443403|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs)|"Treatment-emergent adverse events (TEAEs) were adverse events that occurred after the first dose of study drug.
Treatment-related TEAEs were defined as TEAEs that were considered by the Investigator to be definitely, probably, or possibly related to study drug."|From first dose of study drug through 28 days after the last dose of study treatment (up to 57 days).|Adverse events were assessed using the safety population. The safety population included all participants who received study drug. This population was analyzed as treated.||participants|||Number
690811|NCT01443403|Secondary|Area Under the Concentration-time Curve From Hour 0 to the Time Point of the Last Measurable Concentration Within the Dose Interval (AUC0-τ)|Pharmacokinetic blood samples for naldemedine (S-297995) and its metabolite, Nor-S-297995, were collected from a subset of participants at selected study sites on Day 1 and in a further subset on Day 28.|Day 1 and Day 28 predose and 1, 2 , 4, 8, and 24 hours postdose|PK population with available data||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
690812|NCT01443403|Secondary|Time to Maximum Concentration (Tmax) of Naldemedine and Metabolite Nor-S-297995|Pharmacokinetic blood samples for naldemedine (S-297995) and its metabolite, Nor-S-297995, were collected from a subset of participants at selected study sites on Day 1 and in a further subset on Day 28.|Day 1 and Day 28 predose and 1, 2 , 4, 8, and 24 hours postdose|PK population with available data||hours||Full Range|Median
690813|NCT01443403|Secondary|Maximum Observed Plasma Concentration (Cmax) of Naldemedine and Metabolite Nor-S-297995|Pharmacokinetic blood samples for naldemedine (S-297995) and its metabolite, Nor-S-297995, were collected from a subset of participants at selected study sites on Day 1 and in a further subset on Day 28.|Day 1 and Day 28 predose and 1, 2, 4, 8, and 24 hours postdose|The PK parameter population (PK population) includes all participants who received study drug with at least one PK parameter estimated adequately on Day 1 or Day 28||ng/mL||Geometric Coefficient of Variation|Geometric Mean
690814|NCT01443403|Secondary|Subject Global Satisfaction at End of Treatment|On day 29 (or at early termination), participants were asked about their degree of satisfaction with constipation and abdominal symptoms from the start of study drug dosing to Day 28 (or early termination visit). The grades were as follows: 1, markedly worsened; 2, moderately worsened; 3, slightly worsened; 4, unchanged; 5, slightly improved; 6, moderately improved; and 7, markedly improved.|Day 29, or at early termination|mITT population||participants|||Number
690815|NCT01443403|Secondary|Change From Baseline to Weeks 1, 2, 3, and 4 in Abdominal Discomfort|Participants were asked to rate their abdominal discomfort for the past 24 hours on a scale from 0 to 4, where 0 = Absent; 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Very Severe.|Baseline and Weeks 1, 2, 3, and 4|mITT population with a value at both baseline and the specified time point.||units on a scale||Standard Deviation|Mean
690816|NCT01443403|Secondary|Change From Baseline to the Last 2 Weeks of the Treatment Period in Abdominal Discomfort|Participants were asked to rate their abdominal discomfort for the past 24 hours on a scale from 0 to 4, where 0 = Absent; 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Very Severe.|Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)|mITT population with a value at both baseline and the last 2 weeks of treatment.||units on a scale||Standard Deviation|Mean
690817|NCT01443403|Secondary|Change From Baseline to Weeks 1, 2, 3, and 4 in Abdominal Bloating|Participants were asked to rate their abdominal bloating for the past 24 hours on a scale of 0 to 4, where 0 = Absent; 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Very Severe.|Baseline and Weeks 1, 2, 3, and 4|mITT population with a value at both baseline and the specified time point.||units on a scale||Standard Deviation|Mean
690818|NCT01443403|Secondary|Change From Baseline to the Last 2 Weeks of the Treatment Period in Abdominal Bloating|Participants were asked to rate their abdominal bloating for the past 24 hours on a scale of 0 to 4, where 0 = Absent; 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Very Severe.|Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)|mITT population with a value at both baseline and the last 2 weeks of treatment.||units on a scale||Standard Deviation|Mean
690819|NCT01443403|Secondary|Mean Rescue Laxative Use Per Week During the Treatment Period|Participants were asked how many doses of rescue laxative medication they had taken within the past 24 hours as part of the Bowel Movement and Constipation Assessment Diary (BMCA).|Weeks 1 to 4|mITT population||doses/week||Standard Deviation|Mean
690820|NCT01443403|Secondary|Change From Baseline to the Last 2 Weeks of the Treatment Period in Rescue Use of Laxative Agents Per Week|Participants were asked how many doses of rescue laxative medication they had taken within the past 24 hours as part of the Bowel Movement and Constipation Assessment Diary (BMCA).|Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)|mITT population||doses/week||Standard Deviation|Mean
690821|NCT01443403|Secondary|Change From Baseline to the Last 2 Weeks of the Treatment Period in Number of False Start BMs Per Week|"Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.
A false start was defined as any attempted, but unsuccessful bowel movement (no solid or liquid fecal material was excreted)."|Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)|mITT population with values at both baseline and the last 2 weeks of the treatment period||false start BMs||Standard Deviation|Mean
690822|NCT01443403|Secondary|Change From Baseline to Weeks 1, 2, 3, and 4 in the Number of SBMs Per Week Without Straining|Straining during BMs was graded using the following scale: 0 = No straining; 1 = Mild straining; 2 = Moderate; 3 = Severe; 4 = Very Severe. A BM without straining is defined as a BM with a straining score of 0 or 1.|Baseline and Weeks 1, 2, 3, and 4|mITT population with values at both baseline and the specified time point.||bowel movements/week||Standard Error|Least Squares Mean
690823|NCT01443403|Secondary|Change From Baseline to the Last 2 Weeks of the Treatment Period in Number of SBMs Per Week With no Straining|Straining during BMs was graded using the following scale: 0 = No straining; 1 = Mild straining; 2 = Moderate; 3 = Severe; 4 = Very Severe. A BM without straining was defined as a BM with a straining score of 0 or 1.|Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)|mITT population||bowel movements/week||Standard Error|Least Squares Mean
690824|NCT01443403|Secondary|Change From Baseline to Weeks 1, 2, 3, and 4 in Number of SBMs Rated as 3 or 4 on the Bristol Stool Scale Per Week|Consistency of BMs was measured using the Bristol Stool Scale, according to the following: 1 = separate hard lumps like nuts; 2 = sausage shaped but lumpy; 3 = like a sausage, but with cracks on its surface; 4 = like a sausage or a snake, smooth and soft; 5 = soft blobs and with clear-cut edges; 6 = floppy pieces with ragged edges/mushy stool; 7 = watery, no solid pieces, entirely liquid.|Baseline and Weeks 1, 2, 3, and 4|mITT population with values at both baseline and the specified time point.||spontaneous bowel movements/week||Standard Error|Least Squares Mean
690825|NCT01443403|Secondary|Change From Baseline to the Last 2 Weeks of the Treatment Period in Number of SBMs Per Week Rated as 3 or 4 on the Bristol Stool Scale|Consistency of BMs was measured using the Bristol Stool Scale, according to the following: 1 = separate hard lumps like nuts; 2 = sausage shaped but lumpy; 3 = like a sausage, but with cracks on its surface; 4 = like a sausage or a snake, smooth and soft; 5 = soft blobs and with clear-cut edges; 6 = floppy pieces with ragged edges/mushy stool; 7 = watery, no solid pieces, entirely liquid.|Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)|mITT population||spontaneous bowel movements/week||Standard Error|Least Squares Mean
690826|NCT01443403|Secondary|Percentage of Participants With CSBMs Within 4, 8, 12, and 24 Hours After the Initial Administration of Study Drug|The percentage of participants who experienced at least one CSBM within 4, 8, 12, and 24 hours after the initial administration of study drug and before the second administration.|4, 8, 12, and 24 hours|mITT population||percentage of participants|||Number
690827|NCT01443403|Secondary|Percentage of Participants With SBMs Within 4, 8, 12, and 24 Hours After the Initial Administration of Study Drug|The percentage of participants who experienced at least one SBM within 4, 8, 12, and 24 hours after the initial administration of study drug and before the second administration.|4, 8, 12, and 24 hours|mITT population||percentage of participants|||Number
690828|NCT01443403|Secondary|Time to the First Complete Spontaneous Bowel Movement|Time to the first CSBM was defined as the time to the first CSBM after the initial administration of study drug. Participants who withdrew from the study before a CSBM was observed or had no CSBM during the treatment period were treated as censored.|28 days|mITT population||hours||95% Confidence Interval|Median
690829|NCT01443403|Secondary|Time to the First Spontaneous Bowel Movement|Time to the first SBM was defined as the time to the first SBM after the initial administration of study drug. Participants who withdrew from the study before an SBM was observed or had no SBM during the treatment period were treated as censored.|28 days|mITT population||hours||95% Confidence Interval|Median
690830|NCT01443403|Secondary|Change From Baseline to Weeks 1, 2, 3 and 4 in Number of Days Per Week With CSBMs|"Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.
A CSBM was defined as a spontaneous BM which was accompanied by the feeling of complete evacuation."|Baseline and Weeks 1, 2, 3, and 4|mITT population with values at both baseline and the specified time point.||days/week||Standard Error|Least Squares Mean
690831|NCT01443403|Secondary|Change From Baseline to the Last 2 Weeks of the Treatment Period in Number of Days Per Week With CSBMs|"Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.
A CSBM was defined as a spontaneous BM which was accompanied by the feeling of complete evacuation."|Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)|mITT population||days/week||Standard Error|Least Squares Mean
690832|NCT01443403|Secondary|Change From Baseline to Weeks 1, 2, 3 and 4 in Number of Days Per Week With SBMs|"Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.
An SBM is defined as a bowel movement unassisted by rescue medication (laxative or enema) taken within the 24 hours preceding the bowel movement."|Baseline and Weeks 1, 2, 3, and 4|mITT population with values at both baseline and the specified time point.||days/week||Standard Error|Least Squares Mean
690833|NCT01443403|Secondary|Change From Baseline to the Last 2 Weeks of the Treatment Period in Number of Days Per Week With SBMs|"Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.
An SBM is defined as a bowel movement unassisted by rescue medication (laxative or enema) taken within the 24 hours preceding the bowel movement."|Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)|mITT population||days/week||Standard Error|Least Squares Mean
690834|NCT01443403|Secondary|Percentage of Participants With a CSBM Response at Weeks 1, 2, 3, and 4|"Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.
A CSBM responder was defined as a participant whose frequency of CSBMs during the treatment period was 3 times or more per week and who had an average increase in the frequency of CSBMs from baseline of 1 or more per week."|Baseline and Weeks 1, 2, 3, and 4|mITT population; missing data were imputed using last observation carried forward (LOCF).||percentage of participants|||Number
690835|NCT01443403|Secondary|Percentage of Participants With a CSBM Response in the Last 2 Weeks of the Treatment Period|"Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.
A CSBM responder was defined as a participant whose frequency of CSBMs within the last 2 weeks of the treatment period was 3 times or more per week and who had an average increase in the frequency of CSBMs from baseline of 1 or more per week."|Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)|mITT population||percentage of participants|||Number
690872|NCT01443364|Secondary|Bone Erosion at Week 12|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 12|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690836|NCT01443403|Secondary|Percentage of Participants With an SBM Response at Weeks 1, 2, 3 and 4|"Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.
An SBM responder was defined as any participant whose frequency of SBM per week during the treatment period was 3 times or more per week, and who had an average increase from baseline of 1 or more per week."|Baseline and Weeks 1, 2, 3, and 4|mITT population; missing data were imputed using last observation carried forward (LOCF).||percentage of participants|||Number
690837|NCT01443403|Secondary|Percentage of Participants With an SBM Response in the Last 2 Weeks of the Treatment Period|"Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.
An SBM responder was defined as a participant whose frequency of SBMs within the last 2 weeks of the treatment period was 3 times or more per week and who had an average increase in the frequency of SBMs from baseline of 1 or more per week."|Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)|mITT population||percentage of participants|||Number
690838|NCT01443403|Secondary|Change From Baseline to Weeks 1, 2, 3, and 4 in the Number of Complete Spontaneous Bowel Movements Per Week|"Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.
A CSBM was defined as a spontaneous BM which was accompanied by the feeling of complete evacuation."|Baseline and Weeks 1, 2, 3, and 4|mITT population with values at both baseline and the specified time point.||complete spontaneous BMs per week||Standard Error|Least Squares Mean
690839|NCT01443403|Secondary|Change From Baseline to the Last 2 Weeks of the Treatment Period in the Number of Complete Spontaneous Bowel Movements (CSBMs) Per Week|"Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.
A CSBM was defined as a spontaneous BM which was accompanied by the feeling of complete evacuation."|Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)|mITT population||complete spontaneous BMs per week||Standard Error|Least Squares Mean
690840|NCT01443403|Secondary|Change From Baseline to Weeks 1, 2, 3, and 4 in the Number of Complete Bowel Movements Per Week|"Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.
A complete BM (CBM) was defined as a BM where the participant answered ‘Yes’ to the following question: ‘Did you have a feeling of complete emptying after the bowel movement?’"|Baseline and Weeks 1, 2, 3, and 4|mITT population with values at both baseline and the specified time point.||complete bowel movements per week||Standard Error|Least Squares Mean
690841|NCT01443403|Secondary|Change From Baseline to the Last 2 Weeks of the Treatment Period in the Number of Complete Bowel Movements (CBMs) Per Week|"Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.
A complete BM (CBM) was defined as a BM where the participant answered ‘Yes’ to the following question: ‘Did you have a feeling of complete emptying after the bowel movement?’"|Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)|mITT population||complete bowel movements per week||Standard Error|Least Squares Mean
690842|NCT01443403|Secondary|Change From Baseline to Weeks 1, 2, 3, and 4 in the Number of Bowel Movements Per Week|"Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.
A BM was defined as all bowel movements observed irrespective of the use of a laxative agent."|Baseline and Weeks 1, 2, 3, and 4|mITT population with values at both baseline and the specified time point.||bowel movements per week||Standard Error|Least Squares Mean
690843|NCT01443403|Secondary|Change From Baseline to the Last 2 Weeks of the Treatment Period in the Number of Bowel Movements (BMs) Per Week|"Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.
A BM was defined as all bowel movements observed irrespective of the use of a laxative agent."|Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)|mITT population||bowel movements per week||Standard Error|Least Squares Mean
690844|NCT01443403|Secondary|Change From Baseline to Weeks 1, 2, 3, and 4 in the Number of Spontaneous Bowel Movements Per Week|"Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.
A spontaneous bowel movement was defined as a bowel movement unassisted by rescue medication (laxative or enema) taken within the 24 hours preceding the bowel movement. Baseline was defined as the average number of SBMs per day during the 2 weeks prior to randomization."|Baseline and Weeks 1, 2, 3, and 4|mITT population with values at both baseline and the specified time point.||spontaneous bowel movements per week||Standard Error|Least Squares Mean
690845|NCT01443403|Primary|Change From Baseline to Last 2 Weeks of the Treatment Period in the Number of Spontaneous Bowel Movements Per Week|"Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.
A spontaneous bowel movement was defined as a bowel movement unassisted by rescue medication (laxative or enema) taken within the 24 hours preceding the bowel movement. Baseline was defined as the average number of SBMs per week during the 2 weeks prior to randomization. The number of SBMs per week in the last 2 weeks of treatment is defined as the average number of SBMs per week recorded in the diary for the 14 days prior to the last dose of study drug."|Baseline (2 weeks prior to randomization) and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)|Modified intention-to-treat population||spontaneous bowel movements per week||Standard Error|Least Squares Mean
690846|NCT01443364|Secondary|Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 0|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|Week 0 (Baseline)|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690873|NCT01443364|Secondary|Bone Erosion at Week 24|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 24|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690847|NCT01443364|Secondary|Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 1|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|Week 1|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690848|NCT01443364|Secondary|Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 2|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|Week 2|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690849|NCT01443364|Secondary|Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 4|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|Week 4|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690850|NCT01443364|Secondary|Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 6|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|Week 6|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690851|NCT01443364|Secondary|Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 8|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|Week 8|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690852|NCT01443364|Secondary|Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 12|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|Week 12|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690853|NCT01443364|Secondary|Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 24|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|Week 24|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690854|NCT01443364|Secondary|Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 36|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|Week 36|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690855|NCT01443364|Secondary|Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 52|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|Week 52|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690856|NCT01443364|Secondary|Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 0|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|Week 0 (Baseline)|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690857|NCT01443364|Secondary|Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 1|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|Week 1|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690858|NCT01443364|Secondary|Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 2|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|Week 2|||units on a scale||Full Range|Median
694328|NCT01402115|Secondary|Changes in CTx(Collagen Type 1 Cross-linked C-telopeptide)|CTx(collagen type 1 cross-linked C-telopeptide) was measured in study visit 1(0 week) and visit 3(12 week).|12weeks|per protocol analysis||µg/L||Standard Deviation|Mean
690859|NCT01443364|Secondary|Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 4|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|Week 4|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690860|NCT01443364|Secondary|Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 6|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|Week 6|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690861|NCT01443364|Secondary|Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 8|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|Week 8|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690862|NCT01443364|Secondary|Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 12|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|Week 12|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690863|NCT01443364|Secondary|Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 24|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|Week 24|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690864|NCT01443364|Secondary|Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 36|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|Week 36|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690865|NCT01443364|Secondary|Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 52|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|Week 52|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690866|NCT01443364|Secondary|Bone Erosion at Week 0|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 0 (Baseline)|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690867|NCT01443364|Secondary|Bone Erosion at Week 1|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 1|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690868|NCT01443364|Secondary|Bone Erosion at Week 2|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 2|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690869|NCT01443364|Secondary|Bone Erosion at Week 4|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 4|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690870|NCT01443364|Secondary|Bone Erosion at Week 6|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 6|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690871|NCT01443364|Secondary|Bone Erosion at Week 8|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 8|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690874|NCT01443364|Secondary|Bone Erosion at Week 36|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 36|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690875|NCT01443364|Secondary|Bone Erosion at Week 52|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 52|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690876|NCT01443364|Secondary|Cartilage Damage at Week 0|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 0 (Baseline)|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690877|NCT01443364|Secondary|Cartilage Damage at Week 1|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 1|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690878|NCT01443364|Secondary|Cartilage Damage at Week 2|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 2|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690879|NCT01443364|Secondary|Cartilage Damage at Week 4|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 4|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690880|NCT01443364|Secondary|Cartilage Damage at Week 6|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 6|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690881|NCT01443364|Secondary|Cartilage Damage at Week 8|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 8|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690882|NCT01443364|Secondary|Cartilage Damage at Week 12|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 12|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690883|NCT01443364|Secondary|Cartilage Damage at Week 24|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 24|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690884|NCT01443364|Secondary|Cartilage Damage at Week 36|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 36|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690885|NCT01443364|Secondary|Cartilage Damage at Week 52|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 52|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690886|NCT01443364|Secondary|Doppler Signal and Blood Flow at Week 0|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 0 (Baseline)|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690887|NCT01443364|Secondary|Doppler Signal and Blood Flow at Week 1|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 1|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
692602|NCT01426438|Secondary|Change in Non-HDL Cholesterol|Change in non-HDL Cholesterol (mg/dL) from week 0 to week 24.|0 and 24 weeks|This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.||mg/dL||Inter-Quartile Range|Median
690888|NCT01443364|Secondary|Doppler Signal and Blood Flow at Week 2|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 2|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690889|NCT01443364|Secondary|Doppler Signal and Blood Flow at Week 4|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 4|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690890|NCT01443364|Secondary|Doppler Signal and Blood Flow at Week 6|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 6|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690891|NCT01443364|Secondary|Doppler Signal and Blood Flow at Week 8|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 8|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690892|NCT01443364|Secondary|Doppler Signal and Blood Flow at Week 12|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 12|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690893|NCT01443364|Secondary|Doppler Signal and Blood Flow at Week 24|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 24|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690894|NCT01443364|Secondary|Doppler Signal and Blood Flow at Week 36|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 36|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690895|NCT01443364|Secondary|Doppler Signal and Blood Flow at Week 52|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 52|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690896|NCT01443364|Secondary|Synovial Fluid and Proliferation at Week 0|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 0 (Baseline)|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690897|NCT01443364|Secondary|Synovial Fluid and Proliferation at Week 1|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 1|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690898|NCT01443364|Secondary|Synovial Fluid and Proliferation at Week 2|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 2|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690899|NCT01443364|Secondary|Synovial Fluid and Proliferation at Week 4|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 4|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690900|NCT01443364|Secondary|Synovial Fluid and Proliferation at Week 6|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 6|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690975|NCT01443130|Secondary|Incidence of Stillbirth|Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of participants' deliveries whose outcome was stillbirth, defined as an infant born without any signs of life at 28 weeks or greater of gestation.|At delivery: Approximately 12-36 weeks after enrollment|The analysis population includes all participants whose pregnancies were followed to delivery.||percentage of deliveries||97.5% Confidence Interval|Number
690901|NCT01443364|Secondary|Synovial Fluid and Proliferation at Week 8|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 8|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690902|NCT01443364|Secondary|Synovial Fluid and Proliferation at Week 12|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 12|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690903|NCT01443364|Secondary|Synovial Fluid and Proliferation at Week 24|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 24|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690904|NCT01443364|Secondary|Synovial Fluid and Proliferation at Week 36|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 36|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690905|NCT01443364|Secondary|Synovial Fluid and Proliferation at Week 52|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 52|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690906|NCT01443364|Secondary|Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 1|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|From Baseline to Week 1|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690907|NCT01443364|Secondary|Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 2|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|From Baseline to Week 2|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690908|NCT01443364|Secondary|Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 4|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|From Baseline to Week 4|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690909|NCT01443364|Secondary|Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 6|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|From Baseline to Week 6|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690910|NCT01443364|Secondary|Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 8|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|From Baseline to Week 8|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690911|NCT01443364|Secondary|Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 12|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|From Baseline to Week 12|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690912|NCT01443364|Secondary|Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 24|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|From Baseline to Week 24|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
731612|NCT00405288|Secondary|Gestational Age at Delivery|Fetal gestational age at delivery|until delivery|||gestational weeks||Standard Deviation|Mean
690913|NCT01443364|Secondary|Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 36|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|From Baseline to Week 36|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690914|NCT01443364|Secondary|Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 52|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|From Baseline to Week 52|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690915|NCT01443364|Secondary|Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 1|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|From Baseline to Week 1|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690916|NCT01443364|Secondary|Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 2|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|From Baseline to Week 2|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690917|NCT01443364|Secondary|Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 4|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|From Baseline to Week 4|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690918|NCT01443364|Secondary|Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 6|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|From Baseline to Week 6|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690919|NCT01443364|Secondary|Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 8|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|From Baseline to Week 8|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690920|NCT01443364|Secondary|Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 12|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|From Baseline to Week 12|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690921|NCT01443364|Secondary|Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 24|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|From Baseline to Week 24|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690922|NCT01443364|Secondary|Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 36|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|From Baseline to Week 36|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690923|NCT01443364|Secondary|Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 52|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|From Baseline to Week 52|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
694329|NCT01402115|Primary|Changes in OSC(Osteocalcin)|OSC(Osteocalcin) was measured in study visit 1(0 week) and visit 3(12 week).|12weeks|per protocol analysis||ng/mL||Standard Deviation|Mean
690924|NCT01443364|Secondary|Change From Baseline in the Bone Erosion at Week 1|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 1|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690925|NCT01443364|Secondary|Change From Baseline in the Bone Erosion at Week 2|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 2|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690926|NCT01443364|Secondary|Change From Baseline in the Bone Erosion at Week 4|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 4|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690927|NCT01443364|Secondary|Change From Baseline in the Bone Erosion at Week 6|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 6|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690928|NCT01443364|Secondary|Change From Baseline in the Bone Erosion at Week 8|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 8|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690929|NCT01443364|Secondary|Change From Baseline in the Bone Erosion at Week 12|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 12|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690930|NCT01443364|Secondary|Change From Baseline in the Bone Erosion at Week 24|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 24|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690931|NCT01443364|Secondary|Change From Baseline in the Bone Erosion at Week 36|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 36|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690932|NCT01443364|Secondary|Change From Baseline in the Bone Erosion at Week 52|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 52|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690933|NCT01443364|Secondary|Change From Baseline in the Cartilage Damage at Week 1|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 1|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690934|NCT01443364|Secondary|Change From Baseline in the Cartilage Damage at Week 2|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 2|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690935|NCT01443364|Secondary|Change From Baseline in the Cartilage Damage at Week 4|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 4|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690936|NCT01443364|Secondary|Change From Baseline in the Cartilage Damage at Week 6|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 6|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
691030|NCT01442038|Secondary|Kaplan-Meier Estimates for Time From Randomization to Cardiovascular Death|Time to event distributions were estimated by the Kaplan-Meier method. 1 month = 28 days; 1 calendar year = 365 days.|Baseline through end of study (average 90 weeks)|Full Analysis Set||percentage of participants|||Number
690937|NCT01443364|Secondary|Change From Baseline in the Cartilage Damage at Week 8|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 8|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690938|NCT01443364|Secondary|Change From Baseline in the Cartilage Damage at Week 12|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 12|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690939|NCT01443364|Secondary|Change From Baseline in the Cartilage Damage at Week 24|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 24|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690940|NCT01443364|Secondary|Change From Baseline in the Cartilage Damage at Week 36|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 36|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690941|NCT01443364|Secondary|Change From Baseline in the Cartilage Damage at Week 52|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 52|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690942|NCT01443364|Secondary|Change From Baseline in the Doppler Signal and Blood Flow at Week 1|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 1|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690943|NCT01443364|Secondary|Change From Baseline in the Doppler Signal and Blood Flow at Week 2|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 2|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690944|NCT01443364|Secondary|Change From Baseline in the Doppler Signal and Blood Flow at Week 4|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 4|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690945|NCT01443364|Secondary|Change From Baseline in the Doppler Signal and Blood Flow at Week 6|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 6|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690946|NCT01443364|Secondary|Change From Baseline in the Doppler Signal and Blood Flow at Week 8|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 8|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690947|NCT01443364|Secondary|Change From Baseline in the Doppler Signal and Blood Flow at Week 12|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 12|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690948|NCT01443364|Secondary|Change From Baseline in the Doppler Signal and Blood Flow at Week 24|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 24|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690949|NCT01443364|Secondary|Change From Baseline in the Doppler Signal and Blood Flow at Week 36|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 36|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
732113|NCT00408694|Secondary|Death During or Within 30 Days of Discontinuation of Protocol Treatment.||From discontinuation of protocol treatment to 30 days after.||||||
690950|NCT01443364|Secondary|Change From Baseline in the Doppler Signal and Blood Flow at Week 52|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 52|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690951|NCT01443364|Secondary|Change From Baseline in the Synovial Fluid and Proliferation at Week 1|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 1|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690952|NCT01443364|Secondary|Change From Baseline in the Synovial Fluid and Proliferation at Week 2|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 2|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690953|NCT01443364|Secondary|Change From Baseline in the Synovial Fluid and Proliferation at Week 4|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 4|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690954|NCT01443364|Secondary|Change From Baseline in the Synovial Fluid and Proliferation at Week 6|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 6|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690955|NCT01443364|Secondary|Change From Baseline in the Synovial Fluid and Proliferation at Week 8|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 8|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690956|NCT01443364|Secondary|Change From Baseline in the Synovial Fluid and Proliferation at Week 12|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 12|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690957|NCT01443364|Secondary|Change From Baseline in the Synovial Fluid and Proliferation at Week 24|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 24|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690958|NCT01443364|Secondary|Change From Baseline in the Synovial Fluid and Proliferation at Week 36|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 36|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690959|NCT01443364|Secondary|Change From Baseline in the Synovial Fluid and Proliferation at Week 52|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints, with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 52|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
690960|NCT01443364|Primary|The Percentage of Subjects With Clinical Response at Week 1 Who Also Had Clinical Response at Week 52|Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 [Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system|From Baseline to Week 1 and Week 52|The Full Analysis Set (FAS) will consist of all subjects in the Safety Set (SS) who have a valid baseline and valid post-baseline efficacy measurement for the primary variable (DAS28-ESR). One Subject from the SS has been excluded from the FAS Set.||percentage of subjects||95% Confidence Interval|Number
690961|NCT01443364|Primary|The Percentage of Subjects With Clinical Response at Week 2 Who Also Had Clinical Response at Week 52|Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 [Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system|From Baseline to Week 2 and Week 52|The Full Analysis Set (FAS) will consist of all subjects in the Safety Set (SS) who have a valid baseline and valid post-baseline efficacy measurement for the primary variable (DAS28-ESR). One Subject from the SS has been excluded from the FAS Set.||percentage of subjects||95% Confidence Interval|Number
691031|NCT01442038|Secondary|Kaplan-Meier Estimates for Time From Randomization to Sudden Cardiac Death|Time to event distributions were estimated by the Kaplan-Meier method. 1 month = 28 days; 1 calendar year = 365 days.|Baseline through end of study (average 90 weeks)|Full Analysis Set||percentage of participants|||Number
690962|NCT01443364|Primary|The Percentage of Subjects With Clinical Response at Week 4 Who Also Had Clinical Response at Week 52|Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 [Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system|From Baseline to Week 4 and Week 52|The Full Analysis Set (FAS) will consist of all subjects in the Safety Set (SS) who have a valid baseline and valid post-baseline efficacy measurement for the primary variable (DAS28-ESR). One Subject from the SS has been excluded from the FAS Set.||percentage of subjects||95% Confidence Interval|Number
690963|NCT01443364|Primary|The Percentage of Subjects With Clinical Response at Week 6 Who Also Had Clinical Response at Week 52|Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 [Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system|From Baseline to Week 6 and Week 52|The Full Analysis Set (FAS) will consist of all subjects in the Safety Set (SS) who have a valid baseline and valid post-baseline efficacy measurement for the primary variable (DAS28-ESR). One Subject from the SS has been excluded from the FAS Set.||percentage of subjects||95% Confidence Interval|Number
690964|NCT01443364|Primary|The Percentage of Subjects With Clinical Response at Week 8 Who Also Had Clinical Response at Week 52|Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 [Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system|From Baseline to Week 8 and Week 52|The Full Analysis Set (FAS) will consist of all subjects in the Safety Set (SS) who have a valid baseline and valid post-baseline efficacy measurement for the primary variable (DAS28-ESR). One Subject from the SS has been excluded from the FAS Set.||percentage of subjects||95% Confidence Interval|Number
690965|NCT01443364|Primary|The Percentage of Subjects With Clinical Response at Week 12 Who Also Had Clinical Response at Week 52|Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 [Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system|From Baseline to Week 12 and Week 52|The Full Analysis Set (FAS) will consist of all subjects in the Safety Set (SS) who have a valid baseline and valid post-baseline efficacy measurement for the primary variable (DAS28-ESR). One Subject from the SS has been excluded from the FAS Set.||percentage of subjects||95% Confidence Interval|Number
690966|NCT01443130|Secondary|Incidence of Infection in the Fetal Circulation|Maternal participants were followed to outcome of the pregnancy. This outcome measure provides the number of positive for malaria cord blood smear and cord PCR results in maternal subjects based on the results of the thick smear and PCR from the cord blood sample.|At delivery: Approximately 12-36 weeks after enrollment|The analysis population includes all maternal participants with cord blood smears and cord PCR results obtained.||percentage of participants||97.5% Confidence Interval|Number
690967|NCT01443130|Secondary|Incidence of Clinical Malaria, All Species|Maternal participants were followed to outcome of the pregnancy. Clinical malaria is defined as malaria infection at any parasite density with associated symptoms including at least one of the following: objective fever measured at the clinic, history of fever in the past 48 hours or other symptoms in the last 48 hours including: headache, myalgia, vomiting, or weakness.|Enrollment to delivery (approximately 12-36 weeks)|The analysis population includes all maternal participants.||percentage of participants||97.5% Confidence Interval|Number
690968|NCT01443130|Secondary|Incidence of Malaria Infection, All Species.|Maternal participants were followed to outcome of the pregnancy. This outcome measure provides the number of malaria infection episodes measured by positive parasitemia in maternal subjects.|Enrollment to delivery (approximately 12-36 weeks)|The analysis population includes all maternal participants.||percentage of participants||97.5% Confidence Interval|Number
690969|NCT01443130|Secondary|Incidence of Active Placental Malaria Infection|Maternal participants were followed to outcome of the pregnancy. This outcome measure provides the number of placental malaria infections in maternal subjects diagnosed by the presence of parasites and/or pigment on histological section or molecular evidence of infection (PCR).|At delivery: Approximately 12-36 weeks after enrollment|This analysis population includes all maternal subjects with placental slides reviewed and PCR results obtained.||percentage of participants||97.5% Confidence Interval|Number
690970|NCT01443130|Secondary|Incidence of Intrauterine Growth Restriction (IUGR)|Infants were followed from the time of delivery until 14 weeks of age. This outcome measure provides the incidence of infants with IUGR at delivery. IUGR is defined as weight below the 10th percentile for gestational age based on the World Health Organization (WHO) fetal growth curve. This classification is supported by literature resulting from the INTERGROWTH-21st Project; José Villar.|At delivery: Approximately 12-36 weeks after enrollment|This analysis population includes all infants with weight captured at delivery and with mothers having reported gestational age at delivery.||percentage of participants||97.5% Confidence Interval|Number
690971|NCT01443130|Secondary|Incidence of Low Birth Weight (LBW) (Birthweight < 2500 Grams)|Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of infants whose birthweight was less than 2500 grams.|At delivery: Approximately 12-36 weeks after enrollment|The analysis population includes all infants born alive with weight data collected at birth.||percentage of infants||97.5% Confidence Interval|Number
690972|NCT01443130|Secondary|Infant Mortality Rate to 14 Weeks of Age|Infants were followed from the time of delivery until 14 weeks of age. This outcome measure provides the incidence of infants who died within 14 weeks of delivery.|For 14 weeks after delivery.|The analysis population includes all enrolled infants.||percentage of infants||97.5% Confidence Interval|Number
690973|NCT01443130|Secondary|Incidence of Preterm Delivery|Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of participants' deliveries whose outcome was preterm delivery, defined as delivery less than 37 weeks of gestation. The outcome of the delivery was not considered, and could have been live birth, stillbirth, or miscarriage.|At delivery: Approximately 12-36 weeks after enrollment|The analysis population includes all participants whose pregnancies were followed to delivery.||percentage of deliveries||97.5% Confidence Interval|Number
690974|NCT01443130|Secondary|Incidence of Miscarriage|Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of participants' deliveries whose outcome was miscarriage, defined as an infant delivered without any signs of life at less than 28 weeks of gestation.|At delivery: Approximately 12-36 weeks after enrollment|The analysis population includes all maternal participants.||percentage of pregnancies||97.5% Confidence Interval|Number
699167|NCT01347840|Secondary|Hemoglobin A1c and Lipid Panel|These laboratory values will be collected at Screening, Visit 8, and Visit 10.|16 months|||units on a scale|||Number
690976|NCT01443130|Secondary|Incidence of Maternal Severe Anemia (Hemoglobin < 7gm/dl)|Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of severe anemia among maternal participants during pregnancy. Severe anemia is defined as having a hemoglobin value less than 7 gm/dl.|From enrollment until delivery, approximately 12-36 weeks|The analysis population includes all maternal participants.||percentage of maternal participants||97.5% Confidence Interval|Number
690977|NCT01443130|Secondary|Incidence of Maternal Anemia (Hemoglobin < 10 Grams/Deciliter)|Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of anemia among maternal participants during pregnancy . Anemia is defined as having a hemoglobin value less than 10 grams/deciliter (gm/dL).|From enrollment until delivery, approximately 12-36 weeks|The analysis population includes all maternal participants.||percentage of maternal participants||97.5% Confidence Interval|Number
690978|NCT01443130|Secondary|Incidence of Placental Malaria by Placental Impression Smear|Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of malaria infection in the placenta based on diagnosis by positive placental impression smear results.|At delivery: Approximately 12-36 weeks after enrollment|The analysis population includes all maternal participants whose pregnancies were followed to delivery and from whom a placenta was collected and an impression smear performed.||percentage of placentas||97.5% Confidence Interval|Number
690979|NCT01443130|Primary|Incidence of Placental Malaria Infection Based on Histology|The placenta was collected at the time of delivery for examination by histology to determine malaria infection. Malaria infection was concluded if histology identified parasites or malaria pigment in the placental tissue.|At delivery: Approximately 12-36 weeks after enrollment|All participants from whom the placental histopathology slides collected at the time of delivery were reviewed are included in the analysis.||percentage of pregnancies||97.5% Confidence Interval|Number
690980|NCT01443078|Secondary|Overall Response Rate|"(FDG PET and CT), rate of pathologic down-staging, rate of pathologic response, and stage-specific disease free and overall survival in patients with resectable Stage Ib-IIIa non-squamous, NSCLC treated with neoadjuvant pemetrexed + cisplatin"|2 years||||||
690981|NCT01443078|Primary|PERCIST Partial Metabolic Response|"The primary endpoint was partial metabolic response after 2 cycles of switch therapy as assessed by PERCIST (SUVmax decrease ≥30% using the pre-switch scan as new baseline)."|2 years|||participants|||Number
690982|NCT01443026|Primary|Changes in Serum Biomarkers|Change in serum lycopene, umol/L|baseline and 6 months|||umol/L||Full Range|Mean
690983|NCT01443026|Secondary|Changes in Nuclear Morphometry|We will use a computerized image analysis system designed for the chemoprevention setting to test the hypothesis that the antioxidants cause a favorable change in a nuclear morphometry index based on nuclear size, shape and chromatin texture.|baseline and 6 months||||||
690984|NCT01443026|Primary|Tissue Biomarkers|We will use conventional immunohistochemistry and computer-based image analysis to test the hypothesis that the lycopene supplements alter the expression of proteins marking the status of proliferation, differentiation, cell regulation and apoptosis in high-risk tissue.|baseline and 6 months||||||
690985|NCT01442844|Primary|Percentage of Wound Re-epithelialization||4 weeks|||percentage of wound re-epithelialization||Full Range|Mean
690986|NCT01442779|Secondary|Participants With Change in Cough|changes in cough status after treatment for 1 month.|1 month|During the course of the study it was noted that subjects experienced a change in the cough that is sometimes associated with IPF. The 6 subjects still enrolled in the study were asked to complete a questionnare regarding the status of the cough.||Participants|||Number
690987|NCT01442779|Primary|Minimal/no Change in Quality of Life||12 months|Analysis was performed only on those subject who continue on medication for at least one year.||Participants|||Number
690988|NCT01442779|Primary|Minimal/no Progression (1 yr) by High Resolution Computed Tomography (HRCT) & Pulmonary Function|Disease progression was determined by comparing results of the High Resolution Computed Tomography(HRCT) and pulmonary function at one year to the baseline HRCT & pulmonary function. The same radiologist did the comparsion for all subjects.|1 yr|||Participants|||Number
690989|NCT01442688|Primary|Maximum Plasma Concentration (Cmax) for Amoxicillin|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Assessed over a 24-hour period starting post-dose on day 4|Pharmacokinetic Analysis Set||ug/ml||Standard Deviation|Mean
690990|NCT01442688|Primary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) for Amoxicillin|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Assessed over a 24-hour period starting post-dose on day 4|The Pharmacokinetic Analysis Set was defined as all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. The Safety Analysis Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 postdose safety assessment.||h*ug/ml||Standard Deviation|Mean
690991|NCT01442675|Secondary|Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra®|Solicited injection-site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3 injection-site reactions: Pain - Significant, prevents daily activity; Erythema and Swelling - >100 mm. Grade 3 systemic reactions: Fever - ≥40˚C or ≥104˚F; Headache, Malaise, Myalgia, and Shivering - Significant, prevents daily activity.|Day 0 up to Day 7 post-vaccination|Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set.||Participants|||Number
690992|NCT01442675|Secondary|Geometric Mean Antibody Titer Ratios Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra®|Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC). Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point.|Day 6 and Day 28 post-vaccination|Geometric mean titers ratios (GMTRs) were assessed in the Per-protocol Analysis Set. Serum samples were also collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC GMTRs at this time point.||Titers ratio||95% Confidence Interval|Geometric Mean
694330|NCT01402115|Primary|Changes in DPD(Deoxypyridinoline)|DPD(Deoxypyridinoline) was measured in study visit 1(0 week) and visit 3(12 week).|12weeks|per protocol analysis||nanoMolar DPD per milliMolar creatine||Standard Deviation|Mean
690993|NCT01442675|Secondary|Geometric Mean Antibody Titers Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®|Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC). Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point.|Day 0 (pre-vaccination), Day 6 and Day 28 post-vaccination|Geometric mean titers (GMTs) were assessed in the Per-protocol Analysis Set. Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC GMTs at this time point.||Titers||95% Confidence Interval|Geometric Mean
690994|NCT01442675|Secondary|Number of Participants Achieving At Least Four-Fold Rise in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra®|Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC). Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point.|Day 6 and Day 28 post-vaccination|SBA-HC antibody titers were assessed in the Per-protocol Analysis Set. Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point.||Participants|||Number
690995|NCT01442675|Secondary|Number of Participants Achieving Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®|"Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC).
Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point."|Day 0 (pre-vaccination), Day 6 and Day 28 post-vaccination|SBA-HC antibody titers were assessed in the Per-protocol Analysis Set. Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point.||Participants|||Number
690996|NCT01442675|Secondary|Number of Participants Achieving Antibody Titers ≥1:4 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®|"Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC).
Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point."|Day 0 (pre-vaccination), Day 6 and Day 28 post-vaccination|SBA-HC antibody titers were assessed in the Per-protocol Analysis Set. Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point.||Participants|||Number
690997|NCT01442675|Primary|Number of Participants Achieving Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra®|Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC)|Day 28 post-vaccination|SBA-HC antibody titers were assessed in the Per-protocol Analysis Set.||Participants|||Number
690998|NCT01442493|Secondary|Number of Participants Meeting DSM-IV Cocaine Dependence Criteria|Number of participants meeting DSM-IV cocaine dependence criteria|12-months post-baseline|Baseline values were used when 12 month data were missing||Participants|||Count of Participants
690999|NCT01442493|Secondary|Number of Participants Meeting DSM-IV Opiate Dependence Criteria|Diagnostic and Statistical Manual (DSM)-IV criteria for opiate dependence|12-months post-baseline|Baseline values were used when 12 month data were missing||Participants|||Count of Participants
691000|NCT01442493|Secondary|Global Score on the World Health Organization Quality of Life Measure|Scale from 1 through 5. A higher score reflects a better quality of life.|12-months post-baseline|Baseline values were used when 12 month data were missing||units on a scale||Standard Deviation|Mean
691001|NCT01442493|Secondary|Criminal Behavior|Days of criminal behavior|12-months post-baseline|||Number of Days in the Past 30 days||Standard Deviation|Mean
691002|NCT01442493|Secondary|Drug Use HIV Risk Behavior|HIV Drug Use Risk Assessment Battery Score ranges from 0 to 22. A higher score is considered to be associated with higher risk.|12-months post-baseline|Baseline values were used when 12 month data were missing.||units on a scale||Standard Deviation|Mean
691003|NCT01442493|Secondary|Number of Participants With Cocaine Positive Urine Tests|Cocaine positive urine drug test|12-months post-baseline|Missing data were considered positive||Participants|||Count of Participants
691004|NCT01442493|Primary|Number of Participants With Opiate Positive Urine Tests|Number of participants with opiate positive urine tests|12-months post-baseline|Missing data were counted as positive||Participants|||Count of Participants
691005|NCT01442376|Secondary|Proportion of Patients With Complete Response >24 to 120 Hours (Delayed Phase) in Cycle 1|Complete Response (CR) was defined as no vomiting, no retching, and no use of antiemetic rescue medication from >24 to 120 hours (delayed phase) after T0 (start of administration of the most emetogenic chemotherapy) during first cycle.|from >24 to 120 hours (delayed phase) after T0|Full Analysis Set (FAS) population.||percentage of patients||95% Confidence Interval|Number
691006|NCT01442376|Primary|Proportion of Patients With Complete Response 0 to 24 Hours (Acute Phase) in Cycle 1|Complete Response (CR) was defined as no vomiting, no retching, and no use of antiemetic rescue medication from 0 to 24 hours (acute phase) after T0 (start of administration of the most emetogenic chemotherapy) during first cycle. Time 0 (T0) is defined as the time when the patient starts the first cycle of chemotherapy.|0 to 24 hours after T0|Full Analysis Set (FAS) population||percentage of patients||95% Confidence Interval|Number
691007|NCT01442181|Other Pre-specified|Directed Fluency, Animals|Compare quality of life of patient satisfaction between the surgery and or the medication in stroke patients with AF (atrial fibrillation). The participant is asked to name as many animals as possible beginning with a letter, for one minute.|Change in Baseline, 3 month, and 6 month|Patients with ischemic stroke or transient ischemic attack (TIA) with documented paroxysmal or persistent atrial fibrillation were eligible for the study if they demonstrated the following symptoms: hemiplegia or hemiparesis, monoplegia, or language disturbance.||animals||Standard Deviation|Mean
691872|NCT01435031|Secondary|Target Lesion Failure (TLF)|Composite of cardiac death, target vessel-related MI, and clinically-driven TLR. Per protocol.|1 year|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||Participants|||Count of Participants
691008|NCT01442181|Other Pre-specified|Stroop Word Test|"Compare quality of life of patient satisfaction between the surgery and or the medication in stroke patients with AF (atrial fibrillation). Only 9 patients in the minimally invasive surgery arm completed the stroop word test, and only 6 patients in the medical therapy group completed the stroop word test.
In this test, subjects are asked to read a list of words. 100 is the maximum amount of correct responses per trial."|Change in Baseline, 3 month, and 6 month|Patients with ischemic stroke or transient ischemic attack (TIA) with documented paroxysmal or persistent atrial fibrillation were eligible for the study if they demonstrated the following symptoms: hemiplegia or hemiparesis, monoplegia, or language disturbance.||words||Standard Deviation|Mean
691009|NCT01442181|Other Pre-specified|Wtar (Wechsler Test of Adult Reading) Word List|"Compare quality of life of patient satisfaction between the surgery and or the medication in stroke patients with AF (atrial fibrillation).
The WTAR is composed of 50 irregularly spelled words and takes approximately 10 minutes to complete. The examiner begins by presenting the first word card and prompting the patient for a single pronunciation of the word. This procedure continues through all 50 word cards and is discontinued if the patient provides 12 consecutive incorrect pronunciations. Each correct pronunciation is given a score of 1, with 50 as the maximum raw score."|Baseline|Patients with ischemic stroke or transient ischemic attack (TIA) with documented paroxysmal or persistent atrial fibrillation were eligible for the study if they demonstrated the following symptoms: hemiplegia or hemiparesis, monoplegia, or language disturbance.||words||Standard Deviation|Mean
691010|NCT01442181|Other Pre-specified|Stroop Color Test|"Compare quality of life of patient satisfaction between the surgery and or the medication in stroke patients with AF (atrial fibrillation). Only 9 patients in the minimally invasive surgery arm completed the stroop color test, and only 6 patients in the medical therapy group completed the stroop color test.
In this test, subjects are asked to read a list of color words. 100 is the maximum amount of correct responses per trial."|Change in baseline, 3 month, and 6 month|Patients with ischemic stroke or transient ischemic attack (TIA) with documented paroxysmal or persistent atrial fibrillation were eligible for the study if they demonstrated the following symptoms: hemiplegia or hemiparesis, monoplegia, or language disturbance.||colors||Standard Deviation|Mean
691011|NCT01442181|Other Pre-specified|Hopkins Verbal Learning Test Version A|Compare quality of life of patient satisfaction between the surgery and or the medication in stroke patients with AF (atrial fibrillation). This test measures word recognition. 12 words are read to the subject and they have to repeat as many as they can recall. There are 4 trials, each with 12 total possible words.|Change in baseline, 3 month, and 6 month|Patients with ischemic stroke or transient ischemic attack (TIA) with documented paroxysmal or persistent atrial fibrillation were eligible for the study if they demonstrated the following symptoms: hemiplegia or hemiparesis, monoplegia, or language disturbance.||words||Standard Deviation|Mean
691012|NCT01442181|Other Pre-specified|Directed Fluency; Cowa (Controlled Oral Word Association Test)|Compare quality of life of patient satisfaction between the surgery and or the medication in stroke patients with AF (atrial fibrillation). The participant is asked to name as many words as possible beginning with a letter, excluding proper nouns, for one minute and this procedure is repeated three times.|Change in baseline, 3 month, and 6 month|Patients with ischemic stroke or transient ischemic attack (TIA) with documented paroxysmal or persistent atrial fibrillation were eligible for the study if they demonstrated the following symptoms: hemiplegia or hemiparesis, monoplegia, or language disturbance.||words||Standard Deviation|Mean
691013|NCT01442181|Other Pre-specified|Montreal Cognitive Assessment (Moca)|Compare quality of life of patient satisfaction between the surgery and or the medication in stroke patients with AF (atrial fibrillation). The score is 0 - 30 point test with the higher the score the better cognitive function.|Change in baseline, 3 month, and 6 month|Patients with ischemic stroke or transient ischemic attack (TIA) with documented paroxysmal or persistent atrial fibrillation were eligible for the study if they demonstrated the following symptoms: hemiplegia or hemiparesis, monoplegia, or language disturbance.||units on a scale||Standard Deviation|Mean
691014|NCT01442181|Other Pre-specified|STAI-Form-Y2 Questionnaire (State-Trait Anxiety Inventory)|Compare quality of life of patient satisfaction between the surgery and or the medication in stroke patients with AF (atrial fibrillation). Scores range from 20 to 80, with higher scores correlating with greater anxiety.|Change in baseline, 3 month, and 6 month|Patients with ischemic stroke or transient ischemic attack (TIA) with documented paroxysmal or persistent atrial fibrillation were eligible for the study if they demonstrated the following symptoms: hemiplegia or hemiparesis, monoplegia, or language disturbance.||units on a scale||Standard Deviation|Mean
691015|NCT01442181|Other Pre-specified|STAI-FormY-1 Questionnaire (State-Trait Anxiety Inventory)|Compare quality of life of patient satisfaction between the surgery and or the medication in stroke patients with AF (atrial fibrillation). Scores range from 20 to 80, with higher scores correlating with greater anxiety.|Change in baseline, 3 month, and 6 month|Patients with ischemic stroke or transient ischemic attack (TIA) with documented paroxysmal or persistent atrial fibrillation were eligible for the study if they demonstrated the following symptoms: hemiplegia or hemiparesis, monoplegia, or language disturbance.||units on a scale||Standard Deviation|Mean
691016|NCT01442181|Primary|Quality of Life RAND 36-Item Health Survey|"Compare quality of life of patient satisfaction between the surgery and or the medication in stroke patients with AF (atrial fibrillation).
The RAND 36-Item Health Survey taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. Note that all items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. Items in the same scale are averaged together to create the 8 scale scores which will have a 0 to 100 range."|Change in baseline, 3 month, and 6 month|Patients with ischemic stroke or transient ischemic attack (TIA) with documented paroxysmal or persistent atrial fibrillation were eligible for the study if they demonstrated the following symptoms: hemiplegia or hemiparesis, monoplegia, or language disturbance.||units on a scale||Standard Deviation|Mean
691873|NCT01435031|Secondary|Target Lesion Failure (TLF)|Composite of cardiac death, target vessel-related MI, and clinically-driven TLR. Per protocol.|6 months|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||Participants|||Count of Participants
691017|NCT01442155|Secondary|Safety: Percentage of Participants With Adverse Events|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|Up to 3 years|Safety population included all participants treated with at least one dose of study drug.||percentage of participants|||Number
691018|NCT01442155|Primary|Disease-Free Survival (Time to Event)|Disease free survival was measured as the time from the date of randomization until the date of first event (recurrence of colon cancer, or death due to any cause).|Up to 3 years|Intent-to-treat (ITT) population included all participants treated with at least one dose of study drug. Here, number of participants analyzed is number evaluable for efficacy.||months||95% Confidence Interval|Median
691019|NCT01442129|Secondary|Functional Status and Ventricular Function|"The key efficacy endpoint of this study is functional status and ventricular function, while weaned from LVAD support, at 90 days post intervention (LVAD implantation + intramyocardial injection of study product). Functional status is defined by the ability to tolerate wean from LVAD support for 30 minutes without signs or symptoms of hypoperfusion, including, but not limited to symptoms of low output or signs of vascular congestion. Ventricular function will be assessed by transthoracic echocardiogram (TTE) in those patients able to be weaned for 30 minutes from LVAD support.
The number of participants who successfully tolerated the 30 minute wean from LVAD support at 90 days is reported."|90 days|||participants|||Number
691020|NCT01442129|Primary|Intervention Related Adverse Events|The primary safety endpoint of this study is the incidence of the following potential study-intervention related adverse events within 90 days post intervention (LVAD implantation + intramyocardial injection of study product): infectious myocarditis, myocardial rupture, neoplasm, hypersensitivity reaction, and immune sensitization.|90 days|||events|||Number
691021|NCT01442103|Secondary|Pain Upon Application of Investigational Product.|VAS pain scale will be used to measuring pain at each dressing change.|4 weeks||||||
691022|NCT01442103|Secondary|Infection Assessment|Erythema, edema, warmth, increased drainage, foul odor and fever will be assessed at each visit.|4 weekks||||||
691023|NCT01442103|Primary|Resolution of Signs and Symptoms of Local Wound Infection/Inflammation.|Signs and symptoms of local wound infection/inflammation will be assessed by visual infection assessment (including body temperature) and wound status.|4 weeks|Popul for the asses.of safety was incld all subjs that received at least one device and that provided data after baseline. Prim.analys:ITT, popul incld all subjs that provid.data for the prim endpoint Parameters were summ for the ITT popul using apt sum. statistics. Data described in a descriptive manner only. Efficacy endpoints were sum.by visit.||participants|||Number
691024|NCT01442064|Secondary|Change From Baseline in Visual Function Composite Score, as Measured by the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25)|"NEI VFQ-25 is a 25 item questionnaire that assesses visual function and quality of life for a total possible score of 0 to 100. A higher score represents better functioning. The change from baseline is calculated at Month 12 and Month 24.
Participants are grouped according to the treatment they received in initial studies FVF4165g BRAVO (NCT00486018) and FVF4166g CRUISE (NCT00485836)."|Baseline (Day 0 of extension study), Months 12 and 24|"Enrolled participants for whom data was available for analyses at the given time-points. Observed data were used with no imputation. The number of participants for whom data was available for analyses is represented by n."||Scores on a scale||Standard Deviation|Mean
691025|NCT01442064|Secondary|Change From Baseline in Central Foveal Thickness at Month 6 and Month 12|Change from baseline in Central foveal (retinal) thickness was assessed by Optical Coherence Tomography (OCT). OCT was conducted at the study sites by personnel who were certified by the University of Wisconsin Fundus Photograph Reading Center.|Baseline (Day 0 of extension study), Months 6 and 12|"Enrolled participants for whom data was available for analyses at the given time-point as indicated by n in the categories. Observed data were used with no imputation."||µm||Standard Deviation|Mean
691026|NCT01442064|Secondary|Change From Baseline in the Best Corrected Visual Acuity (BCVA)|Change from baseline in then BCVA was assessed by the number of letters a patient could read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) Eye Chart at a Starting Test Distance of 4 Meters. An increase in the number of letters read indicates improvement in visual acuity.|Baseline (Day 0 of extension study), Months 6, 12, 18, and 24|"Enrolled participants for whom data was available for analyses at the given time-points. Observed data were used with no imputation. The number of participants for whom data was available for analyses is represented by n."||letters||Standard Deviation|Mean
691027|NCT01442064|Primary|Number of Participants With Non-ocular Adverse Events|"Number of participants with non-ocular adverse events (not occurring in the eye) in the following categories: any adverse events, serious adverse events, adverse events leading to study discontinuation and death.
Only adverse events that occurred during this extension study are reported. For subjects in the crossover groups who started their first ranibizumab injection in this extension study, adverse events that occurred prior to any ranibizumab injection were also excluded.
Additional information about adverse events can be found in the adverse events section."|Up to 24 months|Ranibizumab- Treated Participants includes all participants who received Ranibizumab in one of the initial studies or this extension study. This analysis includes only those adverse events that occurred during this extension study.||participants|||Number
691028|NCT01442064|Primary|Number of Participants With Ocular Adverse Events in the Study Eye|"Number of participants with: any ocular adverse events, ocular adverse events causing treatment discontinuation, ocular serious adverse events, intraocular inflammation and cataracts that occurred in the study eye.
Only adverse events that occurred during this extension study are reported. For subjects in the crossover groups who started their first ranibizumab injection in this extension study, adverse events that occurred prior to any ranibizumab injection were also excluded."|Up to 24 months|Ranibizumab- Treated Participants includes all participants who received Ranibizumab in one of the initial studies or this extension study. This analysis includes only those adverse events that occurred during this extension study.||participants|||Number
691029|NCT01442038|Secondary|Kaplan-Meier Estimates for Time From Randomization to Myocardial Infarction|Time to event distributions were estimated by the Kaplan-Meier method. 1 month = 28 days; 1 calendar year = 365 days.|Baseline through end of study (average 90 weeks)|Full Analysis Set||percentage of participants|||Number
691032|NCT01442038|Primary|Kaplan-Meier Estimates for Time From Randomization to First Occurrence of Ischemia-driven Revascularization or Ischemia-driven Hospitalization Without Revascularization|Time to event distributions were estimated by the Kaplan-Meier (KM) method. 1 month = 28 days; 1 calendar year = 365 days.|Baseline through end of study (average 90 weeks)|Full Analysis Set: all participants in the Safety Analysis Set (randomized and received at least one dose of study drug), except participants with no qualifying percutaneous coronary intervention (PCI; formerly known as angioplasty with stent))||percentage of participants|||Number
691033|NCT01441973|Secondary|Number of Participants With a Dose- or Concentration-related Effect on QTcF Interval, PR Interval, QRS Interval, and Heart Rate|All on-treatment electrocardiograms (ECGs) were performed in triplicates ( 1 ECG test equaled 3 consecutive individual 12-lead ECGs performed within a 4-minute period). The timing of the ECG was critical to the endpoint of the study. The investigative site documented any deviations from the protocol or procedures related to ECG collection or serum sampling. No ECGs were excluded due to timing deviations; no deviations were considered clinically relevant and all ECG data were included.|From day of last patient, first dose to 6 months|All participants who received at least 1 dose of study drug||Participants|||Number
691034|NCT01441973|Secondary|Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality|Clinical laboratory evaluations included hematology, chemistry, and liver and renal functioning.|From day of last patient, first dose to 6 months|All participants who received at least 1 dose of study drug||Participants|||Number
691035|NCT01441973|Primary|Linear Regression of Maximal Percent Reduction in Serum Monoclonal (M) Protein on Baseline Percent CD56^Dim Cells in Bone Marrow|Estimated using linear regression model, with baseline CD56^dim cells as the independent covariate, and maximal percent reduction in serum M protein as the dependent variable. For 1 patient who had nonmeasurable disease at baseline, the percent change in serum kappa-lambda difference was used instead of the percent change in serum M protein. Unit of measure=percent change from baseline in M protein cells/ percent change in CD56^dim cells (% chg from BL in M pro/% chg CD56^dim cs)|From day of last patient, first dose to 6 months|All participants who received at least 1 dose of study drug and had the required data (4 participants did not have baseline data available).||% chg from BL in M pro/% chg CD56^dim cs||95% Confidence Interval|Number
691036|NCT01441973|Secondary|Number of Participants Who Died and With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Infusion Reactions|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|From day of last patient, first dose to 6 months|All participants who received at least 1 dose of study drug||Participants|||Number
691037|NCT01441973|Secondary|Objective Response Rate (ORR)|ORR is defined by criteria of modified International Myeloma Working Group as the number of responders (those with stringent compete response [SCR], complete response [CR], very good partial response [VGPR], and partial response [PR])/number of participants in arm. Confidence intervals computed using the Clopper and Pearson method. SCR=CR plus normal free light chain ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence. CR=Negative immunofixation on serum and urine and 5% or fewer plasma cells in bone marrow. VGPR=Serum and urine monoclonal (M) protein detectable by immunofixation but not on electrophoresis or 90% reduction in serum M protein level plus urine M protein level <100 mg/24 hour. PR=50% reduction of serum M protein and reduction in 24-hour urinary M protein by 90% or to <200 mg/24 hour.|From day of last patient, first dose to 6 months|All participants who received at least 1 dose of study drug||Percentage of participants||90% Confidence Interval|Number
691038|NCT01441960|Secondary|Differences in Seizure Duration Between Compounds|Observational reports suggest that differences in seizure duration might exist depending on the neuromuscular blocking agents used to accomplish muscle strength control during ECT.|Up to six weeks following inclusion|||Seconds||Standard Deviation|Mean
691039|NCT01441960|Secondary|Compound Specific Differences in Time to Recovery From Neuromuscular Blockade|The investigators defined the compound specific differences in time to recovery from neuromuscular blockade - i.e., recovery of spontaneous breathing and recovery of the twitch height to baseline.|Up to six weeks following inclusion|||minutes||Standard Deviation|Mean
691040|NCT01441960|Primary|Optimal Dose of Neuromuscular Blocking Agent During ECT|The optimal dose of muscle neuromuscular blocking is defined as the lowest dose of either compound that predicts 'acceptable' control of muscle strength during ECT. Assessment of the primary end point is based on a dichotomous scale 'acceptable' and 'not acceptable' control of muscle strength during ECT, and the two assessors will be blinded to the dose of neuromuscular blocking agent. The optimal dose was identified for each subject, and results were reported as the average of all lowest doses collected in the study.|Up to six weeks following inclusion|||mg.kg-1||95% Confidence Interval|Mean
691041|NCT01441843|Secondary|Somatic Symptoms and Complaints|Medical records are used to assess somatic symptoms and complaints. Next to the medical records, dimensions of the QoR-40 (physical comfort, physical independence and pain) are used to measure somatic symptoms and complaints.|Baseline; first postoperative working day; 1 week after surgery||||||
691042|NCT01441843|Secondary|Depressive Mood|The Hospital Anxiety and Depression Scale (HADS) is used to assess the change in depression. The HADS is a well known international outcome measurement for anxiety and depression. It is often used in the clinical setting. Scores are calculated by summing the scores on the items, and a higher score indicates a higher level of depression.|baseline; 1 week after surgery||||||
691043|NCT01441843|Secondary|Aggression Regulation|The State-Trait Anger Scale (STAS) is used to assess the aggression regulation. STAS is one of the most used tools for measuring aggression. Scores are calculated by summing the scores on the items, and a higher score indicates a higher level of aggression|baseline; 1 week after surgery||||||
691044|NCT01441843|Secondary|Fatigue|The Multidimensional Fatigue Inventory (MFI) is used to assess the change in fatigue. The MFI is a self-report instrument designed to measure fatigue. Scores are calculated by summing the scores on the items, and a higher score indicates a higher level of fatigue.|baseline; 1 week after surgery||||||
691045|NCT01441843|Secondary|Anxiety|The State-Trait Anxiety Inventory (STAI) is used to assess anxiety. Scores are calculated by summing the scores on the items, and a higher score indicates a higher level of anxiety.|baseline; after surgery but before discharge; 1 week after surgery||||||
691046|NCT01441843|Primary|Quality of Recovery Score|"The Quality of Recovery Score - 40 (QoR-40), a 40-item scale, is used to assess the quality of recovery.
Each item is rated on a five-point Likert scale (1-5), and the QoR-40 score is calculated as the sum of the scores on these items. Minimal possible score = 40, maximal possible score = 200. A higher score indicates a higher level of quality of recovery."|Baseline; first postoperative working day; seventh postoperative day.|||scores on a scale||Standard Deviation|Mean
691047|NCT01441765|Secondary|Number of Participants Who Survived at 2 Years|To evaluate overall survival following treatment with CT-011 alone or CT-011 in conjunction with DC/RCC fusion vaccine.|2 years|||participants|||Number
691048|NCT01441765|Secondary|Effect on Circulating Regulatory T Cells|To evaluate the effect of CT-011 alone or in conjunction with DC/RCC fusions on circulating regulatory T cells and PD-1 expression by circulating and bone marrow derived T cells.|2 years|Data was not analyzed as so few participants were enrolled and no participants achieved a PR.|||||
691049|NCT01441765|Secondary|Immunologic Response|To evaluate immunologic response directed against RCC and tumor specific antigens following therapy with CT-011 alone or CT-011 in conjunction with DC/RCC fusion vaccine. Immunologic response will be characterized as peak response post-therapy and ongoing response at 3 and 6 months following treatment.|2 years|Data was not analyzed as so few participants were enrolled and none of the participants achieved a PR or CR.|||||
691050|NCT01441765|Primary|Number of Participants With PR or CR at 2 Years|"To evaluate the complete and partial response rate following completing 4 cycles of CT-011 alone or CT-011 in conjunction with DC/RCC fusion vaccine. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, (with an absolute increase of at least 5 mm), or the appearance of new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study."|2 years|||participants|||Number
691051|NCT01441765|Primary|Number of Participants With Adverse Events|Assessment of toxicity associated with treating patients with metastatic RCC with CT-011 alone or CT-011 in conjunction with DC/RCC. Toxicity was assessed and classified according to CTCAE Version 4.0.|2 years|||participants|||Number
691052|NCT01441596|Secondary|Overall Survival|Overall Survival is defined as time from randomisation to the date of death from any cause.|From first drug administration until 28 days after end of treatment, up to 805 days|RS including only patients who died||weeks||Inter-Quartile Range|Median
691053|NCT01441596|Secondary|Progression-Free Survival|"Progression-Free Survival is defined as the time from the date of randomisation to the date of disease progression or death whichever came first.
Disease progression was defined as either disease progression in CNS lesions (including worsening in NSS and use of corticosteroid) or disease progression in extra-CNS lesions according to RECIST 1.1."|From first drug administration until 28 days after end of treatment, up to 805 days|RS including only patients who experienced disease progression or death||weeks||Inter-Quartile Range|Median
691054|NCT01441596|Primary|Patient Benefit Rate at 12 Weeks|Percentage of patients with patient benefit at week 12. Patient benefit was defined by the absence of central nervous system (CNS) disease progression according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 in addition to no tumour-related worsening of the neurological signs and symptoms (NSS), no tumour-related increase in corticosteroid dosage and no progression of extra CNS disease according to RECIST 1.1|12 weeks from randomisation|Randomised Set (RS): includes all randomised patients, whether treated or not.||percentage of participants||95% Confidence Interval|Number
691055|NCT01441570|Secondary|Blood Pressure|Evaluate the baseline and follow-up systolic and diastolic blood pressures for all subjects in both groups.|12 weeks|||mmHg||Standard Deviation|Mean
691056|NCT01441570|Primary|Quality of Life|"Primary outcome measure will be the change from the Screening/Enrollment Visit to the End of the Study/Early Termination visit in scores of four quality of life questionnaires. The four quality of life questionnaires that were used included the following:
Short Form (SF)-36v2 Health Survey (Score Range = 0-100; the lower the score the more disability)
Sexual Dysfunction Tool for Men = International Index of Erectile Function (IIEF) Questionnaire (Score Range = 5-25; a score of 22-25 = No erectile dysfunction; 17-21 = Mild erectile dysfunction; 12-16 = Mild to moderate erectile dysfunction; 8-11 = Moderate erectile dysfunction; 5-7 = Severe erectile dysfunction)
Sexual Dysfunction Tool for Women = Changes in Sexual Functioning Questionnaire (CSFQ-14-F; Score Range = 14-70; a score at or below 42 is indicative of sexual dysfunction)
Multidimensional Assessment of Fatigue (MAF) Scale (Score Range = 1-50; the higher the score the more fatigue)"|12 weeks; Baseline scores were measured at the Initial Screening/Enrollment Visit (Visit 1 - beginning of week 1); Follow-Up scores were measured at the End of the Study (Visit 2 – End of week 12)|Adult (>18 years of age) renal transplant recipients, both men and women, requiring pharmacotherapy for high blood pressure were evaluated for inclusion in this analysis.||units on a scale||Standard Deviation|Mean
691057|NCT01441466|Secondary|Cross-infection|nosocomially acquired cross-infection|measured until 1 week after hospital exit|||participants|||Number
691058|NCT01441466|Secondary|Mechanical Ventilation|Mechanical ventilation and endotracheal intubation needed|duration of hospitalisation, an average of 3-4 days|||participants|||Number
691059|NCT01441466|Secondary|Highest Dyspnoea Score|highest dyspnoea score (0-10) recorded during admission (0 is no dsypnoea, 10 is highest dyspnoeascore, thus the worst)|duration of hospitalisation, an average of 3-4 days|||units on a scale (0-10)||Standard Deviation|Mean
691060|NCT01441466|Secondary|Supplemental Oxygen Needed|number of days that supplemental oxygen was needed|duration of hospitalisation, an average of 3-4 days|||days||Standard Deviation|Mean
691061|NCT01441466|Secondary|Number of Days With Tube Feeding|number of days the patient has been tube fed|duration of hospitalisation, an average of 3-4 days|||days||Standard Deviation|Mean
691062|NCT01441466|Primary|Duration of Hospital Stay||duration of hospitalisation, an average of 3-4 days|||days||Standard Deviation|Mean
691073|NCT01441414|Secondary|Cmax (Observed Peak Serum PF-04856884 Concentration)|Pharmacokinetic parameter Cmax (observed peak PF-04856884 serum concentration) was estimated using noncompartmental methods.|Pre-dose, 1, 2, 4, 6, 8, 192, 360, 361, 362, 365, 367 hours post dose and end of treatment|The FA set was the primary population for evaluating all safety and efficacy endpoints per the treatment randomization as well as participant characteristics.||ng/mL||Standard Deviation|Mean
691063|NCT01441440|Secondary|Mean Clinical Global Impression - Improvement (CGI-I) Score at Week 8 or Early Termination|CGI-I is a 7-point clinician rated scale ranging from 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, to 7=very much worse. Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Scores above 4 reflect worsening of illness state as compared to baseline.|Baseline, Week 8 or Early termination|Participants randomly assigned to treatment who took at least one dose of the study drug in the double-blind period and who had both baseline and at least one post-baseline measurements of the primary efficacy variable.||Units on a scale||Standard Error|Mean
691064|NCT01441440|Secondary|Changes From Baseline in 16-item Quick Inventory of Depressive Symptomatology Self-Report Japanese Version (QIDS16-SR-J) Total Score at Week 8 or Early Termination|QIDS16-SR-J is a self-rated scale used in patients with major depressive disorder to measure the overall severity of depressive symptoms: 1) sad mood; 2) concentration; 3) self-criticism; 4) suicidal ideation; 5) interest; 6) energy/fatigue; 7) sleep disturbance (initial, middle, and late insomnia or hypersomnia); 8) decrease/increase in appetite/weight; and 9) psychomotor agitation/retardation. QIDS16-SR-J items are rated on a scale of 0 to 3. The total score ranges from 0 to 27, and higher scores indicate more severe symptoms. Change from baseline: mean score at Week 8 or early termination minus mean score at baseline.|Baseline, Week 8 or Early termination|Participants randomly assigned to treatment who took at least one dose of the study drug in the double-blind period and who had both baseline and at least one post-baseline measurements of the primary efficacy variable.||Units on a scale||Standard Error|Mean
691065|NCT01441440|Secondary|Changes From Baseline in 6-item Hamilton Rating Scale for Depression (HAM-D6) Total Score at Week 8 or Early Termination|HAM-D6 is a subset of the HAM-D17 that assesses 6 items associated with major depression. The scale uses HAM-D17 items 1, 2, 7, 8, 10 and 13. Item 13 is scored 0 to 2 and all others are scored 0 to 4. Total score ranges from 0 to 22; higher score indicates more depression. Change from baseline: mean score at Week 8 or early termination minus mean score at baseline.|Baseline, Week 8 or Early termination|Participants randomly assigned to treatment who took at least one dose of the study drug in the double-blind period and who had both baseline and at least one post-baseline measurements of the primary efficacy variable.||Units on a scale||Standard Error|Mean
691066|NCT01441440|Secondary|Changes From Baseline in Clinical Global Impression-Severity (CGI-S) at Week 8 or Early Termination|CGI-S is a 7-point clinician rated scale to assess severity of participant's current illness state; range: 1=normal, not ill at all, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill patients. Higher scores reflect higher severity of current illness states. Change from baseline: mean score at Week 8 or early termination minus mean score at baseline.|Baseline, Week 8 or Early termination|Participants randomly assigned to treatment who took at least one dose of the study drug in the double-blind period and who had both baseline and at least one post-baseline measurements of the primary efficacy variable.||Units on a scale||Standard Error|Mean
691067|NCT01441440|Secondary|Changes From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 8 or Early Termination|MADRS is a scale used in subjects with major depressive disorder to measure the overall severity of depressive symptoms. It is a 10 item, clinician-rated scale that assesses treatment-sensitive change by evaluating ten areas of depressive symptomatology: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts. The items are rated on a 7 point Likert scale (0 – 6) with anchors at 2 point intervals. The total score ranges from 0 to 60, and higher scores indicate more severe symptoms. Change from baseline: mean score at Week 8 or early termination minus mean score at baseline.|Baseline, Week 8 or Early termination|Participants randomly assigned to treatment who took at least one dose of the study drug in the double-blind period and who had both baseline and at least one post-baseline measurements of the primary efficacy variable.||Units on a scale||Standard Error|Mean
691068|NCT01441440|Primary|Change From Baseline in 17-item Hamilton Raing Scale for Depression (HAM-D17) Total Score at Week 8 or Early Termination|HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, work and activities, sleep, suicide, psychomotor agitation/retardation, appetite, sexual interest, anxiety, and somatic symptoms). The items of the HAM-D17 are rated on a scale of 0 to 2 or 0 to 4, and the total score ranges from 0 to 52. Higher scores indicate more severe symptoms. Change from baseline: mean score at Week 8 or early termination minus mean score at baseline.|Baseline, Week 8 or Early termination|Participants randomly assigned to treatment who took at least one dose of the study drug in the double-blind period and who had both baseline and at least one post-baseline measurements of the primary efficacy variable.||Units on a scale||Standard Error|Mean
691069|NCT01441414|Secondary|Overall Survival (OS) at 2 Years|OS is defined as the time from the first dose date to date of death. For participants not expiring, their survival times will be censored at the last date they are known to be alive, or 2 year whichever is earlier. The 2-year OS rate will be estimated from a time-to event analysis of OS.|5 years|This endpoint was not assessed due to the early termination of the study.|||||
691070|NCT01441414|Secondary|Progression Free Survival (PFS) in Adult Participants With Previously Treated Metastatic Renal Cell Cancer (mRCC) as Measured by an Independent Radiological Assessment|PFS is defined as the time (in days) from date of randomization to first documentation of investigator assessed tumor progression or death, whichever comes first. PFS was to be calculated as (first event date – the date of randomization +1).|3 years|This endpoint of estimating median PFS was not assessed due to early termination of the study.|||||
691071|NCT01441414|Secondary|Number of Anti-drug Antibodies (ADA) Samples Confirmed Positive|Detection of neutralizing anti-PF-04856884 antibodies was based on the ability of anti-PF-04856884 neutralizing antibodies to bind to Tag-PF-04856884.|0 and 360 hours post dose and end of study|The FA set was the primary population for evaluating all safety and efficacy endpoints per the treatment randomization as well as participant characteristics.||ADA samples|Participants||Number
691072|NCT01441414|Secondary|Cmin (Trough PF-04856884 Serum Concentration)|Pharmacokinetic parameter Cmin (trough PF-04856884 serum concentration) was estimated using noncompartmental methods.|Pre-dose, 1, 2, 4, 6, 8, 192, 360, 361, 362, 365, 367 hours post dose and end of treatment|The FA set was the primary population for evaluating all safety and efficacy endpoints per the treatment randomization as well as participant characteristics.||ng/mL||Standard Deviation|Mean
691074|NCT01441414|Secondary|Tmax (Time When Maximum Serum PF-04856884 Concentration Was Reached)|Pharmacokinetic parameter, Tmax (Time when maximum serum PF-04856884 concentration was reached) was done using non-compartmental methods.|Pre-dose, 1, 2, 4, 6, 8, 192, 360, 361, 362, 365, 367 hours post dose and end of treatment|The FA set was the primary population for evaluating all safety and efficacy endpoints per the treatment randomization as well as participant characteristics.||hr||Standard Deviation|Mean
691075|NCT01441414|Secondary|Duration of Response (DR) in Metastatic Renal Cell Cancer (mRCC) Patients Treated With PF-04856884 in Combination With AG-013736 vs. AG-013736 Alone|DR is defined as the time from the first documentation of objective tumor response (CR or PR) that is subsequently confirmed to the first documentation of tumor progression or to death due to cancer. Duration of tumor response was to be calculated as (the end date for DR − first CR or PR that is subsequently confirmed +1).|3 years|This endpoint was not assessed due to the early termination of the study.|||||
691076|NCT01441414|Secondary|Overall Response Rate (ORR) in Metastatic Renal Cell Cancer (mRCC) Patients Treated With PF-04856884 in Combination With AG-013736 vs. AG-013736 Alone.|ORR is defined as the proportion of participants with confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST), relative to all randomized participants as defined in the FA Set. Confirmed responses are those that persist on repeat imaging study ≥ 4 weeks after initial documentation of response. Participants who do not have on-study radiographic tumor evaluation or who die, progress, or drop out for any reason prior to reaching a CR or PR will be counted as non-responders (NR) in the assessment of ORR.|4 months|The FA set was the primary population for evaluating all safety and efficacy endpoints per the treatment randomization as well as participant characteristics.||Percentage of participants|||Number
691077|NCT01441414|Secondary|Number of Participants With Non-serious AEs and SAEs|Incidence and severity of all-causality AEs and SAEs to be presented by PT categorized according to Common Terminology Criteria for Adverse Events (CTCAE) grades. Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice daily. Following the decision on 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week).|3 years|This endpoint was not assessed due to the early termination of the study.|||||
691078|NCT01441414|Primary|Progression Free Survival (PFS) in Adult Participants With Previously Treated Metastatic Renal Cell Cancer (mRCC) in Part II|PFS is defined as the time (in days) from date of randomization to first documentation of investigator assessed tumor progression or death, whichever comes first. Progression free survival was to be calculated as (first event date – the date of randomization +1).|3 years|The primary efficacy endpoint of estimating median PFS in Part II was not assessed due to early termination of the study.|||||
691079|NCT01441414|Primary|Number of Participants With Serious Adverse Events (SAEs) in Part I|Incidence and severity of all-causality serious adverse events (SAEs) are presented by PT categorized according to Common Terminology Criteria for Adverse Events (CTCAE) grades. Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice daily. Following the decision on 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week). Participants with treatment-related TEAE are coded as NA if they appear for the same preferred term under all-causality TEAE.|4 months|The FA set was the primary population for evaluating all safety and efficacy endpoints per the treatment randomization as well as participant characteristics.||participants|||Number
691080|NCT01441414|Primary|Number of Participants With Non-serious Adverse Events (AEs) in Part I (Reported in ≥2 of the Participants Overall).|"Incidence and severity of all treatment-emergent AEs (TEAEs) of both all-causality and treatment-related by preferred term (PT) categorized according to Common Terminology Criteria for Adverse Events (CTCAE) grades reported in ≥2 participants overall (CTCAE Grades 3, 4 and 5, combined) for any PT are presented. Participants who are included under all-causality TEAE PT are coded as NA if they appear for the same PT under treatment-related TEAE below.
Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice daily. Following the decision on 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week)."|4 months|The FA set was the primary population for evaluating all safety and efficacy endpoints per the treatment randomization as well as participant characteristics.||participants|||Number
691081|NCT01441401|Other Pre-specified|Reduction From Baseline in Epileptic Seizure Frequency|Reduction from baseline in epileptic seizure frequency was defined by the following formula, where B represented the baseline frequency of epileptic seizures during the previous 4 weeks from the treatment start date, whereas T represented the frequency of epileptic seizures during the previous 4 weeks from the end of assessment period: Reduction from baseline in epileptic seizure frequency (%) = [(T-B) / B] X 100. The median percentages were presented along with the corresponding minimum and maximum percentages.|MAX 104 weeks|The analysis population comprised of the participants in the efficacy analysis population who had assessable data of the frequency of epileptic seizures at the start of gabapentin treatment and at the end of assessment period. n=number of participants with assessable data at each post-baseline time point.||Percentage||Full Range|Median
691082|NCT01441401|Other Pre-specified|Responder Rate|Responder rate, which was defined as the percentage of participants whose R ratio was – 0.333 or less, was presented along with the corresponding exact 2-sided 95% CI. R ratio of – 0.333 or less corresponded to the decrease of epileptic seizure frequency by 50% or more.|MAX 104 weeks|The analysis population comprised of the participants in the efficacy analysis population who had assessable data of the frequency of epileptic seizures at the start of gabapentin treatment and at the end of assessment period. n=number of participants with assessable data at each post-baseline time point.||Percentage of participants||95% Confidence Interval|Number
691112|NCT01441102|Secondary|Number of Study Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 12 Months Compared to Baseline|Fluorescein angiography (FA) images were obtained via a standard digital imaging system (OIS, Sacramento, CA) at baseline and at Month 6, Month 12, Month 18, and Month 24. Three retinal specialists independently graded the area of late fluorescein leakage (at approximately 10 minutes) using a region-of-interest tool in an image analysis software package (NIH ImageJ, Bethesda, MD).|Baseline and 12 Months|||eyes|eyes||Number
691083|NCT01441401|Other Pre-specified|Response Ratio (R Ratio)|R Ratio was calculated by the following formula, where B represented the baseline frequency of epileptic seizures during the previous 4 weeks from the treatment start date, whereas T represented the frequency of epileptic seizures during the previous 4 weeks from the end of assessment period: R Ratio = (T - B) / (T + B). R Ratio is within the range of -1 to +1, and a negative value represents a reduction in the frequency of seizure.|MAX 104 weeks|The analysis population comprised of the participants in the efficacy analysis population who had assessable data of the frequency of epileptic seizures at the start of gabapentin treatment and at the end of assessment period. n=number of participants with assessable data at each post-baseline time point.||Ratio||Standard Deviation|Mean
691084|NCT01441401|Other Pre-specified|Number of Participants With Key Treatment-Related Adverse Events (Aggressive Behaviors)|Aggressive behaviors including affect lability and hostility were determined as key survey items by the sponsor (Pfizer Japan Inc.). These events were defined as the 101 preferred terms listed by pharmaceuticals and medical devices agency and classified according to MedDRA/J version 17.1. A treatment-related adverse event was any untoward medical occurrence attributed to gabapentin in a participant who received gabapentin. Relatedness to gabapentin was assessed by the investigator and sponsor.|MAX 104 weeks|The safety analysis population comprised of participants who had met the inclusion criteria and had taken gabapentin at least once.||Participants|||Number
691085|NCT01441401|Other Pre-specified|Number of Participants With Key Treatment-Related Adverse Events (Central Nervous System Depressant Actions)|Central nervous system depressant actions including somnolence and ataxia were determined as key survey items by the sponsor (Pfizer Japan Inc.). These events were defined according to MedDRA/J version 17.1 as the events classified in “psychiatric disorders” or “nervous system disorders” of the system organ classes, or those classified in “asthenia” or “gait disturbance” of the preferred terms. A treatment-related adverse event was any untoward medical occurrence attributed to gabapentin in a participant who received gabapentin. Relatedness to gabapentin was assessed by the investigator and sponsor.|MAX 104 weeks|The safety analysis population comprised of participants who had met the inclusion criteria and had taken gabapentin at least once.||Participants|||Number
691086|NCT01441401|Secondary|Number of Participants Who Responded to Treatment With Gabapentin by Treatment Period|Participants who responded to the treatment with gabapentin were counted by the treatment period (non-long term [less than 1 year] or long term [1 year or more]) to assess whether the treatment period with gabapentin was a factor affecting the treatment efficacy.|MAX 104 weeks|The efficacy analysis population comprised of the participants who had at least one post-baseline efficacy evaluation for the clinical efficacy and seizure frequency in the safety analysis population. Participants with diseases not eligible for the survey were excluded from the efficacy analysis population.||Participants|||Number
691087|NCT01441401|Secondary|Number of Participants Who Responded to Treatment With Gabapentin by Number of Concomitant Antiepileptic Drugs at Baseline|Participants who responded to the treatment with gabapentin were counted by the number of concomitant epileptic drugs at baseline across 5 categories (no drug, 1 drug, 2 drugs, 3 drugs, and 4 or more drugs) to assess whether the number of concomitant epileptic drugs at baseline was a factor affecting the treatment efficacy.|MAX 104 weeks|The efficacy analysis population comprised of the participants who had at least one post-baseline efficacy evaluation for the clinical efficacy and seizure frequency in the safety analysis population. Participants with diseases not eligible for the survey were excluded from the efficacy analysis population.||Participants|||Number
691088|NCT01441401|Secondary|Number of Participants Who Responded to Treatment With Gabapentin by Baseline Frequency of Epileptic Seizure|Participants who responded to the treatment with gabapentin were counted by the baseline frequency of epileptic seizure (<=8 versus >8 episodes/per 4 weeks) to assess whether the baseline frequency of epileptic seizure was a factor affecting the treatment efficacy.|MAX 104 weeks|The efficacy analysis population comprised of the participants who had at least one post-baseline efficacy evaluation for the clinical efficacy and seizure frequency in the safety analysis population. Participants with diseases not eligible for the survey were excluded from the efficacy analysis population.||Participants|||Number
691089|NCT01441401|Secondary|Number of Participants Who Responded to Treatment With Gabapentin by Baseline Severity of Epileptic Seizure|Participants who responded to the treatment with gabapentin were counted by the baseline severity of epileptic seizure (mild, moderate and severe) to assess whether the baseline severity of epileptic seizure was a factor affecting the treatment efficacy.|MAX 104 weeks|The efficacy analysis population comprised of the participants who had at least one post-baseline efficacy evaluation for the clinical efficacy and seizure frequency in the safety analysis population. Participants with diseases not eligible for the survey were excluded from the efficacy analysis population.||Participants|||Number
691090|NCT01441401|Secondary|Number of Participants With Risk Factors for Treatment-Related Adverse Events|A treatment-related adverse event was any untoward medical occurrence attributed to gabapentin in a participant who received gabapentin. Participants with treatment-related adverse events were counted by each candidate risk factor (including gender, age, and disease eligible for the survey) to assess whether these were risk factors for the treatment-related adverse events. No inferential analyses of risk factors were performed because of a small number of the events (5 events).|MAX 104 weeks|The safety analysis population comprised of participants who had met the inclusion criteria and had taken gabapentin at least once. No data displayed because outcome measure has zero total participants analyzed.|||||
691091|NCT01441401|Secondary|Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert|A treatment-related adverse event was any untoward medical occurrence attributed to gabapentin in a participant who received gabapentin. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to gabapentin was assessed by the investigator and sponsor (Pfizer Japan Inc.).|MAX 104 weeks|The safety analysis population comprised of participants who had met the inclusion criteria and had taken gabapentin at least once.||Participants|||Number
691113|NCT01441102|Secondary|Number of Study Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 6 Months Compared to Baseline|Fluorescein angiography (FA) images were obtained via a standard digital imaging system (OIS, Sacramento, CA) at baseline and at Month 6, Month 12, Month 18, and Month 24. Three retinal specialists independently graded the area of late fluorescein leakage (at approximately 10 minutes) using a region-of-interest tool in an image analysis software package (NIH ImageJ, Bethesda, MD).|Baseline and 6 Months|||eyes|eyes||Number
691092|NCT01441401|Primary|Clinical Efficacy Rate|Clinical efficacy rate, which was defined as the percentage of participants who achieved clinical efficacy over the total number of efficacy analysis population, was presented along with the corresponding exact 2-sided 95% CI. For the basis of efficacy evaluation, frequencies of epileptic seizure were recorded during the previous 4 weeks from the treatment start date, and that from the end date of assessment period. Clinical efficacy was assessed according to the following categories: (1) effective, (2) not effective, or (3) not assessable.|MAX 104 weeks|The analysis population comprised of the participants in the efficacy analysis population from which those with data not assessable were excluded. n=number of participants with assessable data at each post-baseline time point.||Percentage of participants||95% Confidence Interval|Number
691093|NCT01441401|Primary|Number of Participants With Treatment-Related Adverse Events|A treatment-related adverse event was any untoward medical occurrence attributed to gabapentin in a participant who received gabapentin. Relatedness to gabapentin was assessed by the investigator and sponsor (Pfizer Japan Inc.).|MAX 104 weeks|The safety analysis population comprised of participants who had met the inclusion criteria and had taken gabapentin at least once.||Participants|||Number
691094|NCT01441245|Secondary|Dopamine Infusion During Hospitalization||in-hospital|||percentage of partecipants|||Number
691095|NCT01441245|Primary|Evaluation of Renal Function in Terms of GFR Values at Discharge||from admission to discharge, an average of 12 days|Continuous variables are expressed as mean ± standard deviation (SD) and compared with t test for independent groups. p values <0.05 were considered significant||(ml/min·1.73 m2)||Standard Deviation|Mean
691096|NCT01441245|Primary|Evaluation of Renal Function in Terms of Changes in GFR||from admission to discharge, an average of 12 days|||(ml/min·1.73 m2)||Standard Deviation|Mean
691097|NCT01441245|Primary|Change in Brain Natriuretic Peptide (BNP) Levels From Admission to the Discharge||participants were followed for the duration of hospital stay, an average of 13 days|Continuous variables are expressed as mean ± standard deviation (SD) and compared with t test for independent groups. p values <0.05 were considered significant.||pg/mL||Standard Deviation|Mean
691098|NCT01441245|Primary|Evaluation of B-type Natriuretic Peptide (BNP) Levels From Admission to the End of Treatment||from admission to discharge, an average of 12 days|||pg/ml||Standard Deviation|Mean
691099|NCT01441245|Primary|Evaluation of Renal Function in Terms of Changes in Creatinine Levels|evaluation of renal function in terms of changes in creatinine levels during hospitalization in the two arms.|participants were followed for the duration of hospital stay, an average of 13 days|All data were analyzed with intention-to-treat. Continuous variables are expressed as mean ± standard deviation (SD) and compared with t test for independent groups. p values <0.05 were considered significant.||mg/dL||Standard Deviation|Mean
691100|NCT01441245|Primary|Evaluation of Renal Function in Terms of Creatinine Levels at Discharge||from admission to discharge, an average of 12 days|All data were analyzed with intention-to-treat. Continuous variables are expressed as mean ± standard deviation (SD) and compared with t test for independent groups. p values <0.05 were considered significant.||mg/dL||Standard Deviation|Mean
691101|NCT01441245|Secondary|Length of Hospitalization in the Two Groups|percentage of participants with hospital stay > 10 days|in-hospital|Qualitative variables are expressed as percentage and compared with chi-square test . p values <0.05 were considered significant.||percentage of partecipants|||Number
691102|NCT01441245|Primary|Evaluation of Mean Urine Output Volume During the Infusion Period|this study aimed to evaluate the effects of continuous infusion of furosemide in comparison to twice daily regimens at similar doses with respect to changes in renal function in terms of creatinine levels and GFR, urine output and BNP levels from admission to discharge|time period ranging from 72 h to 120 h.|||mL||Standard Deviation|Mean
691103|NCT01441180|Primary|Sustained Virologic Response|Sustained virology response at 24 weeks post treatment completion|24 weeks post treatment completion|on protocol analysis||percentage of total participants||95% Confidence Interval|Number
691104|NCT01441180|Primary|Participants With Adverse Events|Number of participants with Grade 3-4 Adverse Events During the Study Treatment Period as a measure of safety and tolerability.|24 weeks|||partipants|||Number
691105|NCT01441102|Secondary|Number of Participants Withdrawn From the Study Therapy Due to Vision Loss or Adverse Events||Duration of the study, up to 24 months|||participants|||Number
691106|NCT01441102|Secondary|Changes in Mean Macular Sensitivity in the Study Eye at 24 Months Compared to Baseline|Microperimetry was used to assess macular sensitivity.|Baseline and 24 Months|||dB|eyes|Standard Deviation|Mean
691107|NCT01441102|Secondary|Changes in Mean Macular Sensitivity in the Study Eye at 18 Months Compared to Baseline|Microperimetry was used to assess macular sensitivity.|Baseline and 18 Months|||dB|eyes|Standard Deviation|Mean
691108|NCT01441102|Secondary|Changes in Mean Macular Sensitivity in the Study Eye at 12 Months Compared to Baseline|Microperimetry was used to assess macular sensitivity.|Baseline and 12 Months|||dB|eyes|Standard Deviation|Mean
691109|NCT01441102|Secondary|Changes in Mean Macular Sensitivity in the Study Eye at 6 Months Compared to Baseline|Microperimetry was used to assess macular sensitivity.|Baseline and 6 Months|||dB|eyes|Standard Deviation|Mean
691110|NCT01441102|Secondary|Number of Study Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 24 Months Compared to Baseline|Fluorescein angiography (FA) images were obtained via a standard digital imaging system (OIS, Sacramento, CA) at baseline and at Month 6, Month 12, Month 18, and Month 24. Three retinal specialists independently graded the area of late fluorescein leakage (at approximately 10 minutes) using a region-of-interest tool in an image analysis software package (NIH ImageJ, Bethesda, MD).|Baseline and 24 Months|||eyes|eyes||Number
691111|NCT01441102|Secondary|Number of Study Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 18 Months Compared to Baseline|Fluorescein angiography (FA) images were obtained via a standard digital imaging system (OIS, Sacramento, CA) at baseline and at Month 6, Month 12, Month 18, and Month 24. Three retinal specialists independently graded the area of late fluorescein leakage (at approximately 10 minutes) using a region-of-interest tool in an image analysis software package (NIH ImageJ, Bethesda, MD).|Baseline and 18 Months|||eyes|eyes||Number
691144|NCT01440959|Secondary|Number of Participants With Adverse Events|Adverse events will be graded according to Common Terminology Criteria for Adverse events version 3.0, up to 3 year.|Monitoring of adverse events will be continued for at least 28 days following the last dose of study treatment, up to 3 year.|||participants|||Number
691114|NCT01441102|Secondary|Change in Best-corrected Visual Acuity (BCVA) in the Study Eye at 24 Months Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 24 Months|||ETDRS letters|Eyes|Standard Deviation|Mean
691115|NCT01441102|Secondary|Change in Best-corrected Visual Acuity (BCVA) in the Study Eye at 18 Months Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 18 Months|||ETDRS letters|Eyes|Standard Deviation|Mean
691116|NCT01441102|Secondary|Change in Best-corrected Visual Acuity (BCVA) in the Study Eye at 12 Months Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 12 Months|||ETDRS letters|Eyes|Standard Deviation|Mean
691117|NCT01441102|Secondary|Change in Best-corrected Visual Acuity (BCVA) in the Study Eye at 6 Months Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 6 Months|Two participants withdrew from the study prior to the 6-month visit.||ETDRS letters|Eyes|Standard Deviation|Mean
691118|NCT01441102|Secondary|Percentage Change in Retinal Thickness in the Study Eye at 24 Months Compared to Baseline|Retinal thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue. Changes in OCT will be calculated using the ETDRS grid. Attention will be directed to changes in retinal thickness as measured by OCT in each of the 9 subfields of the grid.|Baseline and 24 Months|||percentage change in retinal thickness|eyes|Standard Deviation|Mean
691119|NCT01441102|Secondary|Percentage Change in Retinal Thickness in the Study Eye at 18 Months Compared to Baseline|Retinal thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue. Changes in OCT will be calculated using the ETDRS grid. Attention will be directed to changes in retinal thickness as measured by OCT in each of the 9 subfields of the grid.|Baseline and 18 Months|||percentage change in retinal thickness|eyes|Standard Deviation|Mean
691120|NCT01441102|Secondary|Percentage Change in Retinal Thickness in the Study Eye at 12 Months Compared to Baseline|Retinal thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue. Changes in OCT will be calculated using the ETDRS grid. Attention will be directed to changes in retinal thickness as measured by OCT in each of the 9 subfields of the grid.|Baseline and 12 Months|||percentage change in retinal thickness|eyes|Standard Deviation|Mean
691121|NCT01441102|Primary|Percentage Change in Retinal Thickness in the Study Eye at 6 Months Compared to Baseline|"Retinal thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue. The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria. The eye not chosen as the study eye is referred to as the fellow eye."|Baseline and 6 months|Two participants withdrew from the study prior to the 6-month visit.||percentage change in retinal thickness|Eyes|Standard Deviation|Mean
691122|NCT01441076|Secondary|Physician Global Score|Global visual analogue scale administered by physicians with a range of score of 0-100. Lower scores indicate least symptoms and higher scores indicate worst symptoms faced by the patient.|Baseline|Analysis included all subjects who enrolled in the trial, including those who terminated the study prior to month 6 due to perceived lack of efficacy of study drug.||Units on a scale||Full Range|Median
691123|NCT01441076|Secondary|Patient Global Score|Global visual analogue scale taken by patients with a range of score of 0-100. Lower scores indicate least symptoms and higher scores indicate worst symptoms faced by the patient.|Baseline|Analysis included all subjects who enrolled in the trial, including those who terminated the study prior to month 6 due to perceived lack of efficacy of study drug.||Units on a scale||Full Range|Median
691124|NCT01441076|Secondary|Number of Oral Ulcers by Physician Evaluation|Number of oral ulcers noted by physician evaluation|Baseline|Analysis included all subjects who enrolled in the trial, including those who terminated the study prior to month 6 due to perceived lack of efficacy of study drug.||oral ulcers in participants||Full Range|Median
691125|NCT01441076|Secondary|Number of Genital Ulcers by Physician Evaluation|Number of genital ulcers noted by physician evaluation|Baseline|Analysis included all subjects who enrolled in the trial, including those who terminated the study prior to month 6 due to perceived lack of efficacy of study drug.||genital ulcers in participants||Full Range|Median
691126|NCT01441076|Secondary|Behcets Disease Current Activity Form (BDCAF) Score|The BDCAF is a standardized assessment form in Behcet's disease to measure patient activity. Scoring is based on the history of new clinical features present over the preceding 4 weeks prior to assessment. The range of score is 0 - 12. A total lower score indicates less disease activity and a higher total score indicates more disease activity.|Baseline|Analysis included all subjects who enrolled in the trial, including those who terminated the study prior to month 6 due to perceived lack of efficacy of study drug.||Units on a scale||Full Range|Median
691304|NCT01439971|Primary|Change From Baseline in Body Temperature|Body temperature was measured by mouth (oral) or ear (tympanic). A temperature greater than 38.5 degree Celsius was considered a fever.|Baseline, Day 2, Day 3, and Day 15|The safety population included all enrolled participants who received the study drug.||degree Celcius||Standard Deviation|Mean
691127|NCT01441076|Secondary|Behcet's Syndrome Activity Scale (BSAS) Score|The BSAS is a standardized assessment form in Behcet's disease. The BSAS score comprises 10 items. The total score possible is between 0-100. A total lower score indicates a less syndrome activity and a higher total score indicates more syndrome activity.|Baseline|Analysis included all subjects who enrolled in the trial, including those who terminated the study prior to month 6 due to perceived lack of efficacy of study drug.||Units on a scale||Full Range|Median
691128|NCT01441076|Secondary|Behcet's Disease Related Quality of Life (BDRQOL) Assessment Score|The BDRQOL is a standardized assessment form in Behcet's disease composed of 30 items (answered true or not true) and each item is scored 0 or 1 (scoring range from 0 to 30). A total lower score indicates a better quality of life and a total higher score indicates a worse quality of life.|Baseline|Analysis included all subjects who enrolled in the trial, including those who terminated the study prior to month 6 due to perceived lack of efficacy of study drug.||Units on a scale||Full Range|Median
691129|NCT01441076|Secondary|Physician Global Score|Global visual analogue scale administered by physicians with a range of score of 0-100. Lower scores indicate least symptoms and higher scores indicate worst symptoms faced by the patient.|Month 6 study visit|Analysis included all subjects who enrolled in the trial, including those who terminated the study prior to month 6 due to perceived lack of efficacy of study drug.||Units on a scale||Full Range|Median
691130|NCT01441076|Secondary|Patient Global Score|Global visual analogue scale taken by patients with a range of score of 0-100. Lower scores indicate least symptoms and higher scores indicate worst symptoms faced by the patient.|Month 6 study visit|Analysis included all subjects who enrolled in the trial, including those who terminated the study prior to month 6 due to perceived lack of efficacy of study drug.||Units on a scale||Full Range|Median
691131|NCT01441076|Secondary|Number of Oral Ulcers by Physician Evaluation|Number of oral ulcers noted by physician evaluation|Month 6 study visit|Analysis included all subjects who enrolled in the trial, including those who terminated the study prior to month 6 due to perceived lack of efficacy of study drug.||oral ulcers in participants||Full Range|Median
691132|NCT01441076|Secondary|Number of Genital Ulcers by Physician Evaluation|Number of genital ulcers noted by physician evaluation|Month 6 study visit|Analysis included all subjects who enrolled in the trial, including those who terminated the study prior to month 6 due to perceived lack of efficacy of study drug.||genital ulcers in participants||Full Range|Median
691133|NCT01441076|Secondary|Behcets Disease Current Activity Form (BDCAF) Score|The BDCAF is a standardized assessment form in Behcet's disease to measure patient activity. Scoring is based on the history of new clinical features present over the preceding 4 weeks prior to assessment. The range of score is 0 - 12. A total lower score indicates less disease activity and a higher total score indicates more disease activity.|Month 6 study visit|Analysis included all subjects who enrolled in the trial, including those who terminated the study prior to month 6 due to perceived lack of efficacy of study drug.||Units on a scale||Full Range|Median
691134|NCT01441076|Secondary|Behcet's Syndrome Activity Scale (BSAS) Score|The BSAS is a standardized assessment form in Behcet's disease. The BSAS score comprises 10 items. The total score possible is between 0-100. A total lower score indicates a less syndrome activity and a higher total score indicates more syndrome activity.|Month 6 study visit|Analysis included all subjects who enrolled in the trial, including those who terminated the study prior to month 6 due to perceived lack of efficacy of study drug.||Units on a scale||Full Range|Median
691135|NCT01441076|Secondary|Behcet's Disease Related Quality of Life (BDRQOL) Assessment Score|The BDRQOL is a standardized assessment form in Behcet's disease composed of 30 items (answered true or not true) and each item is scored 0 or 1 (scoring range from 0 to 30). A total lower score indicates a better quality of life and a total higher score indicates a worse quality of life.|Month 6 study visit|Analysis included all subjects who enrolled in the trial, including those who terminated the study prior to month 6 due to perceived lack of efficacy of study drug.||Units on a scale||Full Range|Median
691136|NCT01441076|Primary|Clinical Remission From Months 3-6|Clinical remission was defined as no oral or vaginal ulcers on physical examination for 2 consecutive monthly visits from months 3-6.|Monthly study visits from months 3-6 during the trial|Analysis included all subjects who enrolled in the trial, including those who terminated the study prior to month 6 due to perceived lack of efficacy of study drug.||Participants|||Number
691137|NCT01440972|Secondary|Change in Isokinetic Knee Extensor Strength||4 weeks|||Nm/kg||Standard Error|Least Squares Mean
691138|NCT01440972|Secondary|Change in Knee Injury and Osteoarthritis Outcome Score Pain Subscale|KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life QOL. The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. KOOS is patient-administered, the format is user friendly, and takes about 10 minutes to fill out. Only the pain sub scale was used for the reported study.|4 weeks|||units on a scale||Standard Deviation|Mean
691139|NCT01440972|Secondary|Change in Lower Limb Muscle Power by Double Leg-press at 40% 1 Repetition Maximum||4 weeks|||Watts||Standard Deviation|Mean
691140|NCT01440972|Secondary|Change in Quadriceps Muscle Volume by Magnetic Resonance Imaging||4 weeks|||Percent change||Standard Deviation|Mean
691141|NCT01440972|Primary|Change in Isotonic Double Leg-press 1 Repetition Maximum Strength Scaled to Body Mass||4 weeks|||kg per kg body mass||Standard Deviation|Mean
691142|NCT01440959|Secondary|Overall Survival|Overall survival duration is calculated as time from the first treatment to the date of death. For patients who are still alive at the cut‐off date for statistical reporting, the overall survival duration will be right censored on the last known alive date.|Up to 3 years|||months||95% Confidence Interval|Median
691143|NCT01440959|Secondary|Progression-free Survival|"Progression-free survival is defined as the time from the first treatment to the onset of progressive disease per RECIST criteria or to the date of death whichever comes first. For patients who do not experience progressive disease or death, the progression-free survival duration will be right censored on the last disease assessment date.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions"|Up to 3 years|||months||95% Confidence Interval|Median
691145|NCT01440959|Secondary|Efficacy According to the Concentrations of Circulating Growth Factors|Correlation between efficacy results, such as response, progression-free survival, and overall survival andcirculating growth factors (including vascular endothelial growth factor, fibroblast growth factor, interleukin‐8, placental growth factor, and fibroblast growth factor23), and soluble receptors (including soluble form of membrane bound vascular endothelial growth factor receptor-1 and -2).|Up to 24weeks||||||
691146|NCT01440959|Secondary|Efficacy According to the Primary Mutation Type|Correlation between efficacy results such as response, progression-free survival and overall survival, and primary mutation type including KIT exons 9, 11, 13, and 17 and PDGFRα exons 12 and 18.|Up to 24weeks||||||
691147|NCT01440959|Secondary|Overall Response Rate Using Both CT and PET Scans|PET scan will be performed at baseline and at 4 weeks of treatment. Metabolic response was defined based on the PET response criteria of the European Organization for Research and Treatment of Cancer (EORTC); a metabolic partial response (mPR) was defined as a 25% reduction in average SUVmax; metabolic stable disease (mSD) between a 25% decrease and 25% increase in average SUVmax; metabolic progressive disease (mPD) as a 25% increase in average SUVmax or the appearance of new uptake in metastatic lesions.|Up to 24 weeks|||Percentage of participants|||Number
691148|NCT01440959|Primary|Disease Control Rate (DCR; OR + Stable Disease)|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR; Progressive disease (PD), >20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD), Insufficient change to qualify for PR or PD
This was evaluated with abdominal and pelvic dynamic CT scan every 4 weeks for the initial 8 weeks, and then every 8 weeks."|Up to 24 weeks|||Percentage of participants||95% Confidence Interval|Number
691149|NCT01440946|Secondary|Incremental Recovery (IR; One-stage aPTT Clotting Assay)|IR for FIX activity following rFIXFc dosing: IU/dL rise in plasma FIX per IU/kg drug administered. Non-compartmental methods. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28±7 days before Day 1) Prestudy FIX Dosing: predose; 30±5 min, 3 hrs±30 min, 10±2 hrs, 24±3 hrs, 48±4 hrs postdose. Day 1 rFIXFc Dosing: predose; 30±5 min, 3 hrs ±30 min, 10±2 hrs, 24±3 hrs, 72±7 hrs, 120±12 hrs, 168±16 hrs postdose.|PK Analysis Set: all participants with adequate PK data, defined as complete and evaluable PK samples through 168 hours after rFIXFc dosing. Complete means the availability of the 168-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.||IU/dL per IU/kg||95% Confidence Interval|Geometric Mean
691150|NCT01440946|Secondary|Mean Residence Time (MRT; One-stage aPTT Clotting Assay)|MRT: the average time for all the drug molecules to reside in the body. Non-compartmental methods. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28±7 days before Day 1) Prestudy FIX Dosing: predose; 30±5 min, 3 hrs±30 min, 10±2 hrs, 24±3 hrs, 48±4 hrs postdose. Day 1 rFIXFc Dosing: predose; 30±5 min, 3 hrs ±30 min, 10±2 hrs, 24±3 hrs, 72±7 hrs, 120±12 hrs, 168±16 hrs postdose.|PK Analysis Set: all participants with adequate PK data, defined as complete and evaluable PK samples through 168 hours after rFIXFc dosing. Complete means the availability of the 168-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.||hours||95% Confidence Interval|Geometric Mean
691151|NCT01440946|Secondary|Dose Normalized Area Under the Curve (DNAUC; One-stage aPTT Clotting Assay)|DNAUC: dose normalized area under the drug concentration-time curve (extent of unmetabolized drug in circulation). Non-compartmental methods. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28±7 days before Day 1) Prestudy FIX Dosing: predose; 30±5 min, 3 hrs±30 min, 10±2 hrs, 24±3 hrs, 48±4 hrs postdose. Day 1 rFIXFc Dosing: predose; 30±5 min, 3 hrs ±30 min, 10±2 hrs, 24±3 hrs, 72±7 hrs, 120±12 hrs, 168±16 hrs postdose.|PK Analysis Set: all participants with adequate PK data, defined as complete and evaluable PK samples through 168 hours after rFIXFc dosing. Complete means the availability of the 168-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.||IU*h/dL per IU/kg||95% Confidence Interval|Geometric Mean
691152|NCT01440946|Secondary|Volume of Distribution at Steady State (Vss; One-stage aPTT Clotting Assay)|Vss: volume of distribution at steady state. Non-compartmental methods. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28±7 days before Day 1) Prestudy FIX Dosing: predose; 30±5 min, 3 hrs±30 min, 10±2 hrs, 24±3 hrs, 48±4 hrs postdose. Day 1 rFIXFc Dosing: predose; 30±5 min, 3 hrs ±30 min, 10±2 hrs, 24±3 hrs, 72±7 hrs, 120±12 hrs, 168±16 hrs postdose.|PK Analysis Set: all participants with adequate PK data, defined as complete and evaluable PK samples through 168 hours after rFIXFc dosing. Complete means the availability of the 168-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.||mL/kg||95% Confidence Interval|Geometric Mean
691153|NCT01440946|Secondary|Clearance (CL; One-stage aPTT Clotting Assay)|CL: the measure of the efficiency of the body to remove the drug and the unit is the volume of the plasma or blood cleared of drug per unit time. Non-compartmental methods. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28±7 days before Day 1) Prestudy FIX Dosing: predose; 30±5 min, 3 hrs±30 min, 10±2 hrs, 24±3 hrs, 48±4 hrs postdose. Day 1 rFIXFc Dosing: predose; 30±5 min, 3 hrs ±30 min, 10±2 hrs, 24±3 hrs, 72±7 hrs, 120±12 hrs, 168±16 hrs postdose.|PK Analysis Set: all participants with adequate PK data, defined as complete and evaluable PK samples through 168 hours after rFIXFc dosing. Complete means the availability of the 168-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.||mL/h/kg||95% Confidence Interval|Geometric Mean
691154|NCT01440946|Secondary|Terminal Half Life (t1/2; One-stage aPTT Clotting Assay)|t1/2: time required for the concentration of the drug to reach half of its original value in the body. Non-compartmental methods. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28±7 days before Day 1) Prestudy FIX Dosing: predose; 30±5 min, 3 hrs±30 min, 10±2 hrs, 24±3 hrs, 48±4 hrs postdose. Day 1 rFIXFc Dosing: predose; 30±5 min, 3 hrs ±30 min, 10±2 hrs, 24±3 hrs, 72±7 hrs, 120±12 hrs, 168±16 hrs postdose.|PK Analysis Set: all participants with adequate PK data, defined as complete and evaluable PK samples through 168 hours after rFIXFc dosing. Complete means the availability of the 168-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.||hours||95% Confidence Interval|Geometric Mean
691155|NCT01440946|Secondary|Maximum Plasma Activity (Cmax; One-stage Activated Partial Thromboplastin Time [aPTT] Clotting Assay)|Cmax: maximum plasma FIX activity during a dosing interval. The values for Cmax were adjusted to the nominal dose of 50 IU/kg. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28±7 days before Day 1) Prestudy FIX Dosing: predose; 30±5 min, 3 hrs±30 min, 10±2 hrs, 24±3 hrs, 48±4 hrs postdose. Day 1 rFIXFc Dosing: predose; 30±5 min, 3 hrs ±30 min, 10±2 hrs, 24±3 hrs, 72±7 hrs, 120±12 hrs, 168±16 hrs postdose.|PK Analysis Set: all participants with adequate PK data, defined as complete and evaluable PK samples through 168 hours after rFIXFc dosing. Complete means the availability of the 168-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.||IU/dL||95% Confidence Interval|Geometric Mean
691156|NCT01440946|Secondary|Total Dose Required for Resolution of a Bleeding Episode|The total dose required to resolve a bleeding episode per participant and per episode, based on the efficacy period. The efficacy period begins with the first prophylactic dose of rFIXFc and ends with the last dose (for prophylaxis or a bleeding episode). Surgery/rehabilitation periods and PK evaluation periods are not included in the efficacy period. For 'Per bleeding episode' values, for each bleeding episode, the total dose is the sum of the doses (IU/kg) administered across all injections given to treat that bleeding episode. For 'Per participant' values, the total dose (IU/kg) used to resolve each bleeding episode is averaged across all bleeding episodes per participant.|Up to 50 weeks +/- 7 days (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFIXFc; number of participants and number of episodes were determined for participants who had complete information on the dose administered to treat a bleeding episode.||IU/kg|Bleeding Episodes|Inter-Quartile Range|Median
691157|NCT01440946|Secondary|Number of Injections Required for Resolution of a Bleeding Episode|The number of injections required to resolve a bleeding episode per participant and per episode, based on the efficacy period. The efficacy period begins with the first prophylactic dose of rFIXFc and ends with the last dose (for prophylaxis or a bleeding episode). Surgery/rehabilitation periods and PK evaluation periods are not included in the efficacy period. All injections given from the initial sign of a bleeding episode, until the last date/time within the bleeding episode window are counted. The resolution of a bleeding episode is defined as no sign of bleeding following injection for the bleeding episode. For 'Per participant' values, the number of injections required to resolve each bleeding episode is averaged across all bleeding episodes per participant.|Up to 50 weeks +/- 7 days (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFIXFc; number of participants and number of episodes were determined for participants with at least 1 evaluable bleeding episode.||injections|Bleeding Episodes|Inter-Quartile Range|Median
691158|NCT01440946|Secondary|Number of Days From the Last Prophylaxis Injection to a Spontaneous Bleeding Episode|The number of days from the last prophylaxis injection to the onset of a new spontaneous bleeding episode, analyzed across all evaluable bleeding episodes per participant and per episode, based on the efficacy period. Evaluable bleeding episodes are those for which both a date and time are available for both the onset of the bleeding episode and the previous prophylactic injection. The efficacy period begins with the first prophylactic dose of rFIXFc and ends with the last dose (for prophylaxis or a bleeding episode). Surgery/rehabilitation periods and PK evaluation periods are not included in the efficacy period. For 'Per participant' values, the number of days from the last prophylactic injection to a spontaneous bleeding episode is averaged across all evaluable spontaneous bleeding episodes per participant.|Up to 50 weeks +/- 7 days (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFIXFc; number of participants and number of episodes were determined for participants with at least 1 evaluable spontaneous bleeding episode.||days|Evaluable Spontaneous Bleeding Episodes|Inter-Quartile Range|Median
691159|NCT01440946|Secondary|Annualized rFIXFc Consumption by Type of Injection|Annualized consumption of rFIXFc for prevention of bleeding (prophylactic), treatment of bleeding, and other rFIXFc injections. Consumption is calculated for the efficacy period. The efficacy period began with the first prophylactic dose of rFIXFc and ended with the last dose (regardless of the reason for dosing). Surgery/rehabilitation and PK evaluation periods were not included in the efficacy period. Annualized consumption = (total IU/kg of study treatment received during the efficacy period / total number of days during the efficacy period)*365.25. Participants who did not have a particular injection type are counted as having zero injections for that type.|Up to 50 weeks +/- 7 days (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFIXFc.||IU/kg rFIXFc per year||Standard Deviation|Mean
691160|NCT01440946|Secondary|Physician's Global Assessment of the Participant's Response to His rFIXFc Regimen|Investigators assessed each participant's response to his rFIXFc regimen using a 4-point scale: excellent=bleeding episodes responded to ≤ the usual number of injections or ≤ the usual dose of rFIXFc or the rate of breakthrough bleeding during prophylaxis was ≤ that usually observed; effective=most bleeding episodes responded to the same number of injections and dose, but some required more injections or higher doses, or there was a minor increase in the rate of breakthrough bleeding; partially effective=bleeding episodes most often required more injections and/or higher doses than expected, or adequate breakthrough bleeding prevention during prophylaxis required more frequent injections and/or higher doses; ineffective=routine failure to control hemostasis, or hemostatic control required additional agents. Percentages are based on the total number of responses; multiple responses per participant are counted.|Up to 50 weeks +/- 7 days|Full Analysis Set: participants who received ≥ 1 dose of rFIXFc; based on the number of responses.||percentage of responses|responses||Number
691171|NCT01440764|Primary|Subject Rating of Breathing Discomfort (Dyspnea)|Change in breathing discomfort (dyspnea) rating at benchmark PETCO2 using a visual analog scale. The change in breathing discomfort is expressed as units on a 0% to 100% continuous scale, where higher values represent more dyspnea. The change is represented as the rating of breathing discomfort after the intervention minus the rating of breathing discomfort before the intervention.|The breathing discomfort ratings were taken as an average of all ratings during runs before intervention and the first two runs after intervention. The 1st and 2nd post-runs began (on average) 12 minutes and 49 minute after intervention, respectively.|||units on a scale||Standard Error|Mean
691172|NCT01440647|Secondary|Percentage of Participants With Reintubation|Reintubation rate is a measure of the efficacy of NIPPV.|0-7 days post-extubation|||% of participants with reintubation|||Number
691173|NCT01440647|Primary|Number of Days Being Intubated||30 days from birth|||days||Full Range|Median
691161|NCT01440946|Secondary|Participant Assessment of Response to Injections to Treat a Bleeding Episode|Participant's assessment of the response (provided by the caregiver) to the first rFIXFc injection for each bleeding episode. Percentages were based on the number of bleeding episodes for which a response was provided for the first injection, using the following 4-point scale: excellent=abrupt pain relief and/or improvement in signs of bleeding within approximately 8 hours after the initial injection; good=definite pain relief and/or improvement in signs of bleeding within approximately 8 hours after an injection, but possibly requiring more than one injection after 24 to 48 hours for complete resolution; moderate=probable or slight beneficial effect within 8 hours after the initial injection and requiring more than one injection; no response=no improvement, or condition worsened, within approximately 8 hours after the initial injection.|Up to 50 weeks +/- 7 days|Full Analysis Set: participants who received at least 1 dose of rFIXFc and had ≥ 1 bleeding episode; based on the number of injections with an evaluation.||percent of 1st injections w/ a response|Injections||Number
691162|NCT01440946|Secondary|Annualized Joint Bleeding Rate (Spontaneous)|Annualized bleeding rate for spontaneous joint bleeding episode=(number of bleeding episodes meeting those criteria during the efficacy period/total number of days during the efficacy period)*365.25. Efficacy period begins with the first prophylactic dose of rFIXFc and ends with the last dose (for prophylaxis or a bleeding episode). Surgery/rehabilitation periods and PK evaluation periods are not included in the efficacy period. A bleeding episode started from the first sign of bleeding and ended ≤ 72 hours after the last treatment for the bleeding episode, within which any symptoms of bleeding at the same location or injections ≤ 72 hours apart were considered the same bleeding episode. Any injection to treat the bleeding episode taken > 72 hours after the preceding 1 was considered the first injection to treat a new bleeding episode at the same location. Any bleeding at a different location was considered a separate bleeding episode, regardless of time from last injection.|Up to 50 weeks +/- 7 days (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFIXFc; based on the number of participants whose efficacy period is of at least 1 day in duration.||bleeding episodes per participant per yr||Inter-Quartile Range|Median
691163|NCT01440946|Secondary|Annualized Bleeding Rate|Annualized bleeding rate = (number of bleeding episodes during the efficacy period / total number of days during the efficacy period)*365.25. The efficacy period begins with the first prophylactic dose of rFIXFc and ends with the last dose (for prophylaxis or a bleeding episode). Surgery/rehabilitation periods and PK evaluation periods are not included in the efficacy period. A bleeding episode started from the first sign of bleeding and ended no more than 72 hours after the last treatment for the bleeding episode, within which any symptoms of bleeding at the same location or injections less than or equal to 72 hours apart were considered the same bleeding episode. Any injection to treat the bleeding episode taken more than 72 hours after the preceding one was considered the first injection to treat a new bleeding episode at the same location. Any bleeding at a different location was considered a separate bleeding episode, regardless of time from last injection.|Up to 50 weeks +/- 7 days (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFIXFc; based on the number of participants whose efficacy period was of at least 1 day in duration.||bleeding episodes per participant per yr||Inter-Quartile Range|Median
691164|NCT01440946|Primary|Occurence of Factor IX (FIX) Inhibitor Development|An inhibitor test result ≥ 0.6 Bethesda units (BU)/mL, confirmed on 2 separate samples drawn 2 to 4 weeks apart, was considered positive. Both tests were to be performed by the central laboratory using the Nijmegen-modified Bethesda Assay. Incidences were summarized for any positive inhibitor for participants with ≥ 50 exposure days (EDs) to rFIXFc. In addition, the incidence for all participants, regardless of their EDs to rFIXFc, was also summarized. An exact 95% CI for the proportion of participants with a confirmed inhibitor was calculated using the Clopper-Pearson exact method for a binomial proportion.|Up to 50 weeks +/- 7 days, or up to 50 EDs if reached prior to Week 50|Safety Analysis Set: participants who received at least 1 dose of prestudy FIX, or at least 1 dose of rFIXFc; n=number of participants with given number of EDs who had a valid inhibitor test.||percentage of participants||95% Confidence Interval|Number
691165|NCT01440881|Primary|The Examine and Measure Urinary NGAL to Measure Kidney Injury|Urinary NGAL,a biomarker for kidney injury was measured.|A change in urinary NGAL 2 hours after bypass was stopped and 5 minutes after the start of spontaneous circulation was resumed.|randomized as outlined in protocol||ng/ml||Inter-Quartile Range|Median
691166|NCT01440881|Primary|The Examine and Measure Endothelin-1 to Measure Kidney Injury|Serial measurements of Endothelin-1 levels were measured to determine if natriuretic peptides exert their renal protective effects by preserving renal afferent arteriole flow by antagonizing the vasoconstrictive effects of Endothelin-1.|30 days from the start of infusion|randomized as outlined in the protocol||pg/ml||Inter-Quartile Range|Median
691167|NCT01440881|Primary|The Examine and Measure Cytokines to Measure Kidney Injury|Serial measurement of serum cytokine profiles were measured with multiplex Luminex plates that enable the simultaneous measurement of 23 cytokines.|30 days from the start of infusion|randomized per protocol||pg/ml||Inter-Quartile Range|Median
691168|NCT01440881|Primary|Measure Neutrophils to Measure Kidney Injury|0.35 mL of whole blood from each patient was applied to a microfluidics chip to isolate neutrophils. Total RNA was subsequently isolated and gene expression (for all genes listed below) was measured with an Affymetrix gene chip. Data was normalized using RMA (Robust multi-array average) and expressed as log2 expression.|30 days from the start of infusion|||log2 expression||Standard Deviation|Mean
691169|NCT01440764|Secondary|Urine Output|Diuresis is an expected effect of furosemide. To the extent that aerosol furosemide is absorbed into the blood, diuresis is an expected 'side effect' of this treatment|Cumulative urine output 1 hour after intervention|||ml of urine||Standard Deviation|Mean
691170|NCT01440764|Secondary|Multidimensional Dyspnea Profile|Characterization of subject's response to laboratory dyspnea model. Data are from a baseline pre-treatment test on the first drug or placebo treatment day for the subjects used in the main analysis. Subjects were asked to complete the MDP with reference to the last 30 sec of each run. To weigh subjects equally, we selected one run from each subject: the first run that terminated in a rating of overall breathing discomfort (A1) of 50 to 90% of full scale. The units of measurement are expressed as units on a 0 to 10 scale measuring intensity of a given quality, with higher values indicating greater intensity and 10 representing maximum perceived intensity.|Measured before intervention|||units on a scale||Standard Error|Mean
733988|NCT00424190|Secondary|Microbiological Reinfection or Recurrence at the LFU Visit||21 to 35 days after the last dose of study drug||||||
691174|NCT01440634|Primary|Effect of an Exercise Intervention on Walking Ability (Functional Outcome)|Walking distance (Six-Minute Walk test). Following a standardized protocol, individuals are instructed to walk back and forth a 100-ft hallway as far as they can in six minutes after instructions to cover as much distance as possible. A research assistant walks slightly behind each participant so as not to pace the individual. The research assistant records whether or not each person stops during the 6-minute walk. During the proposed study, members of the research team and trained lay health promoters (LHPs) will walk directly behind the individuals and give standardized instructions of encouragement at set intervals. Data will be reported on meters walked.|6 months|||meters||Standard Deviation|Mean
691175|NCT01440595|Secondary|Number of Participants Achieving Complete Early Virologic Response (cEVR) at Week 24 in the Placebo Arm|cEVR was defined as undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 24 (i.e., after 12 weeks of placebo + 12 weeks of grazoprevir treatment). HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.|Week 24|The Full Analysis Set (FAS) population includes all randomized participants who received at least 1 dose of study treatment. No participants completed treatment, and no analyses were conducted for this study due to early termination.|||||
691176|NCT01440595|Secondary|Number of Participants Achieving Undetectable HCV RNA at Week 12 in the Placebo Arm|HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.|Week 12|The Full Analysis Set (FAS) population includes all randomized participants who received at least 1 dose of study treatment. No participants completed treatment, and no analyses were conducted for this study due to early termination.|||||
691177|NCT01440595|Secondary|Number of Participants Achieving Sustained Viral Response 24 Weeks After Completion of Therapy (SVR24)|SVR24 was defined as undetectable HCV RNA 24 weeks after completion of study therapy. HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.|Week 36 for Grazoprevir treatment arms, Week 48 for Placebo arm|The Full Analysis Set (FAS) population includes all randomized participants who received at least 1 dose of study treatment. No participants completed treatment, and no analyses were conducted for this study due to early termination.|||||
691178|NCT01440595|Secondary|Number of Participants Achieving Sustained Viral Response 12 Weeks After Completion of Therapy (SVR12)|SVR12 was defined as undetectable HCV RNA 12 weeks after completion of study therapy. HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.|Week 24 for Grazoprevir treatment arms, Week 36 for Placebo arm|The Full Analysis Set (FAS) population includes all randomized participants who received at least 1 dose of study treatment. No participants completed treatment, and no analyses were conducted for this study due to early termination.|||||
691179|NCT01440595|Secondary|Number of Participants Achieving Rapid Viral Response (RVR)|RVR was defined as undetectable HCV RNA at Week 4. HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.|Week 4|The Full Analysis Set (FAS) population includes all randomized participants who received at least 1 dose of study treatment. No participants completed treatment, and no analyses were conducted for this study due to early termination.|||||
691180|NCT01440595|Secondary|Time to First Achievement of Undetectable HCV Ribonucleic Acid (RNA)|Time to first achievement of undetectable HCV RNA was determined by measuring HCV RNA at Treatment Days 1, 3, and 7; Treatment Weeks 2, 4, 8, 12, 16, 20, and 24; as well as Follow-up Weeks 4, 12, and 24. HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.|Baseline to Week 12 for Grazoprevir treatment arms, Week 24 for Placebo arm|The Full Analysis Set (FAS) population includes all randomized participants who received at least 1 dose of study treatment. No participants completed treatment, and no analyses were conducted for this study due to early termination.|||||
691181|NCT01440595|Primary|Number of Participants Achieving Complete Early Virologic Response (cEVR) in the Grazoprevir Treatment Arms|cEVR was defined as undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12. HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v.2.0 assay.|Week 12|The Full Analysis Set (FAS) population includes all randomized participants who received at least 1 dose of study treatment. No participants completed treatment, and no analyses were conducted for this study due to early termination.|||||
691182|NCT01440569|Secondary|Percentage of Participants Experiencing Any Treatment-emergent Adverse Event and Any Treatment-emergent Adverse Event Leading to Discontinuation of Study Drug Through Week 48||Up to 48 weeks|Full Analysis Set||percentage of participants|||Number
691183|NCT01440569|Secondary|Percentage of Participants Experiencing Any Treatment-emergent Adverse Event and Any Treatment-emergent Adverse Event Leading to Discontinuation of Study Drug Through Week 24||Up to 24 weeks|Full Analysis Set||percentage of participants|||Number
691184|NCT01440569|Secondary|Change From Baseline in CD4+ Cell Count at Week 48||Baseline; Week 48|Full Analysis Set; the Missing = Excluded method was used, where participants with missing data were excluded from the analysis.||cells/µL||Standard Deviation|Mean
691185|NCT01440569|Secondary|Change From Baseline in CD4+ Cell Count at Week 24||Baseline; Week 24|Full Analysis Set; the Missing = Excluded method was used, where participants with missing data were excluded from the analysis.||cells/μL||Standard Deviation|Mean
691186|NCT01440569|Secondary|Percentage of Participants Achieving HIV-1 RNA < 50 Copies/mL at Week 48 (Snapshot Analysis)||Week 48|Full Analysis Set||percentage of participants|||Number
691187|NCT01440569|Secondary|Percentage of Participants Achieving HIV-1 RNA < 50 Copies/mL at Week 24 (Snapshot Analysis)||Week 24|Full Analysis Set||percentage of participants|||Number
691188|NCT01440569|Primary|Percentage of Participants With Onset of Any Treatment-emergent Grade 3 or 4 Adverse Event Between Baseline and Week 24||Up to 24 weeks|Full Analysis Set||percentage of participants|||Number
691189|NCT01440543|Primary|Success Rate of Minimal Sedation Colonoscopy|A succesful colonoscopy using assigned technique was defined as reaching the caecum without switching to another insertion method and without additional sedation beyond the initial 2 mg of midazolam. Any time the further insertion of the scope was not possible, the patient reported pain level > 3 using a 7-point Likert scale [7] (0 = no pain, 6 = intolerable pain) or demanded additional sedation, the endoscopist preferentially switched to the other insertion technique. Enhanced sedation was used in case the other technique had not been successful.|6 months|Statistical power was calculated for the primary endpoint. A sample size of 145 subjects per insertion arm was calculated using two-tailed α = 0,05, β = 0,05, assuming that 80% versus 60% success rate in the water (Water/CO2 and Water/Air) and gas (CO2/CO2 and Air/Air) insertion arms would have been clinically relevant.||percentage of all participants|||Number
733989|NCT00424190|Secondary|Clinical Relapse at the Late Follow Up (LFU) Visit||21 to 35 days after the last dose of study drug||||||
691190|NCT01440543|Secondary|Patient Comfort During the Procedure and During First 24 Hours After Procedure|Comfort was assessed using a 18-point questionnaire form based on 0-6 continuous scale (0 = best, 6 = worst)- abdominal pain during, 30 minutes, 3, 12 and 24 hours after the procedure, bloating duringm 30 minutes, 3, 12 and 24 hours after the procedure, flatus during, 30 minutes, 3, 12 and 24 hours after the procedure, impact on patient´s daily activities during first 24 hours after the procedure, willingnes to repeat the colonoscopy and overall satisfaction with the procedure|six months||||||
691191|NCT01440543|Primary|Success Rate of Minimal Sedation Colonoscopy|Successful minimal sedation colonoscopy using assigned technique was defined as reaching the caecum without switch to another insertion method and / or without additional sedation beyond the initial administration of 2 mg of midazolam.|six months||||||
691192|NCT01440517|Secondary|Uptake of 99mTc-maraciclatide Agent in Diabetic Subjects With Heart Failure With Preserved Left Ventricular Fraction and Subjects With Diabetes Mellitus and Asymptomatic Diastolic Dysfunction|Due to the lack of subject enrollment, efficacy data were not analyzed.|Time zero equals the date of contrast imaging and for up to 24 hours for safety monitoring post contrast administration.|Due to the lack of subject enrollment, efficacy data were not analyzed.|||||
691193|NCT01440517|Primary|Evidence of Active Myocardial Angiogenesis/Remodeling|Due to the lack of subject enrollment, efficacy data were not analyzed.|Time zero equals the date of contrast imaging and for up to 24 hours for safety monitoring post contrast administration.|Due to the lack of subject enrollment, efficacy data were not analyzed.|||||
691194|NCT01440387|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|A serious adverse event was any untoward medical occurrence that resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|During the entire study period (Day 0 - Day 20 after vaccination).|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.||Subjects|||Number
691195|NCT01440387|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).|An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 21-day (Days 0-20) post-vaccination period.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.||Subjects|||Number
691196|NCT01440387|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed were chest tightness, chills, cough, fatigue, headache, joint pain at other location, muscle pain, red eyes, sore throat, swelling of the face and fever [oral temperature ≥ 38.0 degrees Celsius (°C)]. Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = oral temperature above 39.0°C|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.||Subjects|||Number
691197|NCT01440387|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal everyday activities. Grade 3 redness and swelling were defined as redness/swelling greater than 100 millimeters (mm). i.e. >100mm.|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.||Subjects|||Number
691198|NCT01440387|Primary|HI Antibody Seroconversion Factors (SCFs) Against Each of the 4 Vaccine Influenza Strains.|SCFs were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains assessed were Yamagata, Victoria, H1N1 and H3N2 antigens.|At Day 21|The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. These included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Fold increase||95% Confidence Interval|Geometric Mean
691199|NCT01440387|Primary|Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains.|A seroconverted subject was defined as a subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Yamagata, Victoria, H1N1 and H3N2 antigens.|At Day 21|The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. These included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
691200|NCT01440387|Primary|Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains.|A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. The vaccine strains assessed were Yamagata, Victoria, H1N1 and H3N2 antigens.|At Day 0 and Day 21|The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. These included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
691305|NCT01439971|Primary|Change From Baseline in Body Weight||Baseline, Day 2, Day 3, and Day 15|The safety population included all enrolled participants who received the study drug.||kilograms (kg)||Standard Deviation|Mean
694331|NCT01402102|Secondary|Changes in FFA(Free Fatty Acid)|FFA(free fatty acid) was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis||µEq/L||Standard Deviation|Mean
691201|NCT01440387|Primary|Humoral Immune Response in Terms of Hemagglutination Inhibition (HI) Antibodies Against Each of the 4 Vaccine Influenza Strains.|Antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu B/Florida/4/06 (Yamagata), FluB/Bri/60/08 (Victoria), Flu A/CAL/7/09 (H1N1) and Flu A/Victoria/210/09 (H3N2) antigens.|At Day 0 and Day 21|The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. These included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Titers||95% Confidence Interval|Geometric Mean
691202|NCT01440374|Secondary|EQ-5D Utility Score Analysis|"EuroQoL Five Dimensions Questionnaire (EQ-5D) is a standardized generic preference based health related quality of life instrument. It records how one’s health is “today” and consists of a descriptive system. The Descriptive system is Comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension on the EQ-5D involves a 3-point response scale which indicates the level of impairment (level 1 = no problem; level 2 = some or moderate problem(s) and level 3 = unable, or extreme problems). Level of problem reported in each EQ-5D dimension determines a unique health state which is converted into a weighted health state index by applying scores from EQ-5D preference weights elicited from general population samples. This generates a unique description of the subjects’ health status, which is valued between 0 (representing death) and 1 (representing perfect health). Higher the score, the better the quality of life.
EQ-ED is a score."|Change from baseline, up to week 12|Part 2 Population (Intent-to-Treat population)||Adjusted mean change from baseline||Standard Error|Mean
691203|NCT01440374|Secondary|Functional Assessment of Cancer Therapy (FACT)|"The FACT-Th-18 is the most widely used and accepted tool evaluating health-related quality-of-life outcomes in cancer patients with chronically low platelets (where Th designates thrombocytopenia). The entire FACT-Th-18 was used in this trial, which includes the 18-item thrombocytopenia subscale used to assess the impact of symptoms, signs, and functional consequences of thrombocytopenia in MDS and AML subjects. The FACT-Th-18 is a validated and reliable instrument with known psychometric properties. FACT-ThS is an 18 item questionnaire specific to assessing the impact of symptoms, signs, and functional consequences of Thrombocytopenia. ThS score ranges from 0 to 72 with higher the score, the better the QoL. FACT G total score moves from 0 to 108 where higher the score, the better the HRQL.
FACT-Th Total Score is calculated by adding the FACT-ThS and FACT-G score. Total score ranges from 0 to 180 and again, higher the score, the better the HRQL."|Change from baseline, up to week 12|Part 2 Population (Intent-to-Treat population)||Adjusted mean change from baseline||Standard Error|Mean
691204|NCT01440374|Secondary|Summary of Health Outcomes|"The number of subject with medical resource utilization (MRU) data are reported in this table.
MRU included number of emergency room visits, number of home healthcare visits, number of hospitalization days, number of medication or surgery specialist visits, number of procedures inpatient, number of procedures outpatient, number of non-study radiology visits, number of non-study laboratory visits, number of nurse practitioner/physician assistance/nurse visits, number of primary care physician visits, number of telephone consultations."|week 12|Part 2 Population (Intent-to-Treat population)||Subject with Events|||Number
691205|NCT01440374|Secondary|Median Overall Survival||Up to 13 months|Part 2 Population (Intent-to-Treat population)||Months||95% Confidence Interval|Median
691206|NCT01440374|Secondary|Independent Reviewer Assessed Disease Progression||Up to week 12|Part 2 Population (Intent-to-Treat population)||Number of subjects|||Number
691207|NCT01440374|Secondary|Independent Reviewer-Assessed Best Response|Participants were evaluated in accordance with the modified International Working Group (Cheson, 2006). CR: Bone marrow blasts <5%, Hgb ≥11g/dL, Hematologic Improvement – Platelets (Baseline <20Gi/L: >20 Gi/L and 2x baseline; Baseline ≥20 Gi/L: ≥50 Gi/L and 2x baseline), Neutrophils ≥1.0 Gi/L, Peripheral blasts 0%. PR: Bone marrow blasts decreased by ≥50% but >5%, Peripheral blood as in CR. Marrow CR: Bone marrow blasts <5% and decrease by ≥50%, Note any Hematologic Improvements, Stable disease: Failure to achieve PR, but no evidence of progression for >8w, Cytogenetic response: Complete: disappearance of chromosomal abnormality; no new abnormalities Partial: ≥50% reduction of chromosomal abnormality.|up to week 12|Part 2 Population (Intent-to-Treat population)||Number of subjects|||Number
691208|NCT01440374|Secondary|Number of Participants With Maximum Bleeding Grade According to World Health Organization on Bleeding Scale|Occurrence and severity of bleeding, measured using the WHO Bleeding Scale Grade 0=no bleeding; Grade 1=petechiae; Grade 2=mild blood loss; Grade 3=gross blood loss; Grade 4=debilitating blood loss.|Weeks 5 to 12|Part 2 Population (Intent-to-Treat population)||Number of subjects|||Number
691209|NCT01440374|Secondary|Maximum Duration of Platelet Transfusion Independence||Weeks 5 to 12|Part 2 Population (Intent-to-Treat population)||maximum duration of platelet transfusion||Standard Deviation|Mean
691210|NCT01440374|Secondary|Change in Mean Platelet Count||Baseline to Week 12|Part 2 Population (Intent-to-Treat population)||Gi/L||Standard Deviation|Mean
691211|NCT01440374|Secondary|Hematologic Improvement|Definitions of hematologic improvement for platelets, neutrophils, and hemoglobin were based on modified International Working Group (IWG) consensus criteria.|Weeks 5 to 12|Part 2 Population (Intent-to-Treat population)||Number of subjects|||Number
691212|NCT01440374|Secondary|Mean Number of Platelet Transfusions||Weeks 5 to 12|Part 2 Population (Intent-to-Treat population)||Number of platelet transfusions||Standard Deviation|Mean
691213|NCT01440374|Secondary|Plasma Eltrombopag Pharmacokinetic Concentration-Time Data - by Visit (Part 2 Subjects)||Day 1 to week 12|Pharmacokinetic population||ug/mL||Standard Deviation|Mean
691214|NCT01440374|Secondary|Plasma Eltrombopag Pharmacokinetic Concentration-Time Data - by Visit (Part 1 Subjects)||Day 1 to week 8|Pharmacokinetic population: all subjects in All Subjects Population who had a PK blood sample obtained/analyzed.||ug/mL||Standard Deviation|Mean
691215|NCT01440374|Primary|Clinically Relevant Thrombocytopenic Events (CRTE) From Week 5 up to Week 12 During Part 2|A participant was considered to have a CRTE at a given assessment if he/she had platelet counts <10 Gi/L, or platelet transfusions, or >=Grade 3 hemorrhagic adverse events. CRTEs during Weeks 5 to 12 were compared between treatments using a generalized linear mixed model. Average of weekly proportion of subjects with CRTE during Week 5 to 12 was estimated for each treatment. Intent to Treat (ITT) Population was comprised of all randomized participants during Part 2.|From Week 5 up to Week 12 during Part 2|Part 2 Population (Intent-To-Treat (ITT) Population: all randomized subjects in part 2)||percentages of participants||95% Confidence Interval|Mean
691216|NCT01440374|Primary|Number of Participants With Platelet Response up to Week 8 During Part 1|A participant was considered as a responder if he/she met the following response criteria: a Baseline platelet count <20 Giga cells per liter (Gi/L) and a post-Baseline increased to >20 Gi/L and at least 2 times the Baseline value; or a Baseline platelet count >=20 Gi/L and a post-Baseline absolute platelet count increased to >=50 Gi/L and at least 2 times the Baseline value. The response criteria was evaluated at each visit. Increase in platelet count observed up to 3 days after a platelet transfusion was not considered as a platelet response. The Part 1 Population was comprised of all participants enrolled into Part 1.|From Baseline up to Week 8 during Part 1|Part 1 Population: all subjects who enrolled in Part 1.||Participants|||Number
691217|NCT01440322|Secondary|Back Surface Deposits (None, Very Slight)|"Back surface deposits on the contact lens, as assessed by the investigator for each eye individually. Back surface deposits were rated on a 5-point scale: 0=none, 1=very slight, 2=slight, 3=moderate, 4=severe. The combined percentage of lenses assessed as none or very slight is reported. Lenses from both eyes contributed to the percentage."|Up to Month 3|"The analysis population includes all enrolled and dispensed participants who completed the study. No imputation was used for missing values. Here, n is the number of eyes with non-missing values at the specific time point for each arm group, used as the denominator for percentage calculation."||Percentage of lenses|Participants||Number
691218|NCT01440322|Secondary|Front Surface Deposits (None, Very Slight)|"Front surface deposits on the contact lens, as assessed by the investigator for each eye individually. Front surface deposits were rated on a 5-point scale: 0=none, 1=very slight, 2=slight, 3=moderate, 4=severe. The combined percentage of lenses assessed as none or very slight is reported. Lenses from both eyes contributed to the percentage."|Up to Month 3|"The analysis population includes all enrolled and dispensed participants who completed the study. No imputation was used for missing values. Here, n is the number of eyes with non-missing values at the specific time point for each arm group, used as the denominator for percentage calculation."||Percentage of lenses|Participants||Number
691219|NCT01440322|Secondary|Dry Areas/Non-Wetting (None, Very Slight)|"Dry areas/non-wetting (i.e., assessment of the disruption of the front surface wettability of the contact lens), as assessed by the investigator for each eye individually. Dry areas/non-wetting was rated on a 5-point scale: 0=none, 1=very slight, 2=slight, 3=moderate, 4=severe. The combined percentage of lenses assessed as none or very slight is reported. Lenses from both eyes contributed to the percentage."|Up to Month 3|"The analysis population includes all enrolled and dispensed participants who completed the study. No imputation was used for missing values. Here, n is the number of eyes with non-missing values at the specific time point for each arm group, used as the denominator for percentage calculation."||Percentage of lenses|Participants||Number
691220|NCT01440322|Secondary|Lens Centration (Centered, Slight Decentration)|"Lens centration, as assessed by the investigator for each eye individually. Lens centration was rated on a 5-point scale: 0=centered, 1=slight decentration, 2=mild decentration, 3=moderate decentration, 4=severe decentration. The combined percentage of lenses assessed as centered or slight decentration is reported. Lenses from both eyes contributed to the percentage."|Up to Month 3|"The analysis population includes all enrolled and dispensed participants who completed the study. No imputation was used for missing values. Here, n is the number of eyes with non-missing values at the specific time point for each arm group, used as the denominator for percentage calculation."||Percentage of lenses|Participants||Number
691221|NCT01440322|Secondary|Lens Fit (Optimal, Acceptably Loose, Acceptably Tight)|"Lens fit, as assessed by the investigator for each eye individually. Lens fit was rated on a 5-point scale: 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, -2=unacceptably tight. The combined percentage of lenses assessed as optimal, acceptably loose, or acceptably tight is reported. Lenses from both eyes contributed to the percentage."|Up to Month 3|"The analysis population includes all enrolled and dispensed participants who completed the study. No imputation was used for missing values. Here, n is the number of eyes with non-missing values at the specific time point for each arm group, used as the denominator for percentage calculation."||Percentage of lenses|Participants||Number
691222|NCT01440322|Secondary|Subjective Rating of Overall Handling|Overall handling, as rated by the participant on a 10-point scale, with 1 being difficult and 10 being easy. The participant rated both eyes together by providing one single rating.|Up to Month 3|"The analysis population includes all enrolled and dispensed participants who completed the study. No imputation was used for missing values. Here, n is the number of participants with non-missing values at the specific time point for each arm group."||Units on a scale||Standard Deviation|Mean
691223|NCT01440322|Secondary|Subjective Rating of Overall Comfort|Overall comfort, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.|Up to Month 3|"The analysis population includes all enrolled and dispensed participants who completed the study. No imputation was used for missing values. Here, n is the number of participants with non-missing values at the specific time point for each arm group."||Units on a scale||Standard Deviation|Mean
691224|NCT01440322|Secondary|Subjective Rating of Overall Vision|Overall vision, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.|Up to Month 3|"The analysis population includes all enrolled and dispensed participants who completed the study. No imputation was used for missing values. Here, n is the number of participants with non-missing values at the specific time point for each arm group."||Units on a scale||Standard Deviation|Mean
691225|NCT01440322|Primary|Contact Lens-Corrected Distance Monocular Snellen Visual Acuity (VA) (20/30 or Better)|Visual acuity, as assessed for each eye individually. Participant read a distance Snellen chart while wearing study lenses. The percentage of eyes with VA recorded as 20/30 or better is reported. Both eyes contributed to the percentage.|Up to Month 3|"The analysis population includes all enrolled and dispensed participants who completed the study. No imputation was used for missing values. Here, n is the number of eyes with non-missing values at the specific time point for each arm group, used as the denominator for percentage calculation."||Percentage of eyes|Participants||Number
691226|NCT01440283|Secondary|Quantify (in mm/cm) the Range of Target Movement During the Breathing Phase Measured by 4DMRI and 4DCT.|Obtain target tissue motion-defining data which can guide future more conformal therapeutic regimens incorporating smaller volumes of uninvolved tissue.|Baseline and approximately 2 weeks following initiation of irradiation.|All participants underwent complete surgery prior to RT, therefore, no visible tumor tissue target was available for movement measurements.|||||
691227|NCT01440283|Secondary|Quantify the Range of Organ Movement During the Breathing Phase Measured by 4-dimensional MRI (4DMRI) and 4DCT.|Normal tissue motion-defining measurements were obtained which can guide future more conformal therapeutic regimens incorporating smaller volumes of uninvolved tissue. Participants underwent CT simulation and 4D-CT acquisition as well as real-time dynamic 4D MRI prior to the start of radiation therapy (RT), and a subsequent repeat 4D-CT was obtained approximately 2 weeks after the start of RT. The imaging position was supine with general anesthesia. Renal edges were marked in a customized graphical interface for each imaging series with the image resolution determining the minimum motion extent. Vectors of renal edge motion were quantified in the anterior-posterior (A-P), medial-lateral (M-L), and superior-inferior (S-I) dimensions. The motion extent derived from the MRI dataset was considered in defining the margins for RT treatment planning.|Baseline and approximately 2 weeks following initiation of irradiation.|Five participants did not receive all scans for motion evaluations and are excluded from the analysis. Age at scan ranges from 8 months to 9.5 years old. The median age was 3.8 years.||mm||Standard Deviation|Mean
691228|NCT01440283|Primary|Pattern of Local-regional Failure.|Categorical measurements of local-regional failure.|2 years after last patient enrollment|There was no local-regional failure noted (please see outcome #1), therefore, no pattern of failure could be determined.|||||
691229|NCT01440283|Primary|Percentage of Participants Who Failed to Reach Local-regional Control|Measured from start of radiation therapy to date of local-regional failure or last follow-up.|2 years after last patient enrollment|||percentage of participants|||Number
691230|NCT01440101|Secondary|Part A: Summary of Lymphocyte Counts Over Time||Baseline [Week 0]); 28 days post-dose; Weeks 12, 24, and 32 (follow-up)|Participants in Part A who received a dose of BG00002 and had at least 1 post-baseline assessment of lymphocytes; n=participants with assessment at timepoint.||cells/microliter||Standard Deviation|Mean
691231|NCT01440101|Secondary|Part A: Natalizumab Binding Saturation Of α4 Integrin Sites On Peripheral Blood Mononuclear Cells (PBMC)|Pharmacodynamic activity was assessed by measuring the degree of saturation by BG00002 of the very late antigen-4 (VLA-4, also known as α4β1 integrin) receptor on peripheral blood mononuclear cell populations. This was accomplished by staining cells with phycoerythrin-conjugated anti-human immunoglobulin G4 (IgG4) antibody (hIgG4-PE) to label the cell-bound BG00002, followed by flow cytometric detection and quantification.|Pre-dose; 4 hours post-dose; 7, 14, 21, and 28 days post-dose; Weeks 8, 12, and 16: pre-dose; Week 20: pre-dose; 4 hours post-dose; 7, 14, 21, and 28 days post-dose|Participants in Part A who received a dose of BG00002 and had at least 1 post-baseline assessment of α4-integrin saturation; n=participants with an assessment at timepoint.||percent saturation||Standard Deviation|Mean
691232|NCT01440101|Secondary|Part B: Number of Participants With Adverse Events (AEs)|AE=any untoward medical occurrence that did not necessarily have a causal relationship with this treatment. Serious AE (SAE)=any untoward medical occurrence that at any dose: resulted in death; in the view of the Investigator, was a life threatening event; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; or any other medically important event that, in the opinion of the Investigator, may have jeopardized the participant or may have required intervention to prevent one of the other outcomes listed in the definition above. Events were categorized as related or not related; severity was categorized as mild, moderate, or severe.|Baseline (Week 0) to Week 24|||participants|||Number
691233|NCT01440101|Secondary|Part B: Status of Serum Antibodies to Natalizumab|Persistent positivity is defined as 2 positive results separated by at least 6 to 12 weeks.|Baseline (Week 0) and Week 24|Participants with one or more post-baseline screening antibody result.||participants|||Number
691234|NCT01440101|Secondary|Part A: Pharmacokinetic (PK) Profile of Natalizumab in Serum: CL|Systemic clearance (CL) was calculated using non-compartmental methods.|Dose 1/Week 0: pre-dose, post-dose and 4, 24, 48 and 96 hours post-dose|Randomized participants who received at least 1 infusion of BG00002 and had at least 1 post-baseline assessment of BG00002 serum concentration.||mL/h||Full Range|Geometric Mean
691235|NCT01440101|Secondary|Part A: Pharmacokinetic (PK) Profile of Natalizumab in Serum: Vd|Volume of distribution (Vd) was calculated using non-compartmental methods.|Dose 1/Week 0: pre-dose, post-dose and 4, 24, 48 and 96 hours post-dose; Dose 6/Week 20 pre-dose, post-dose, and 4, 24, 48 and 96 hours post-dose; 7, 14, and 21 days post-dose|Randomized participants who received at least 1 infusion of BG00002 and had at least 1 post-baseline assessment of BG00002 serum concentration; n = the number of these participants with an assessment at given timepoint.||L||Full Range|Geometric Mean
691236|NCT01440101|Secondary|Part A: Pharmacokinetic (PK) Profile of Natalizumab in Serum: Tmax and T1/2|Time to maximum concentration (Tmax) and half-life (T1/2) were calculated using non-compartmental methods.|Dose 1/Week 0: pre-dose, post-dose and 4, 24, 48 and 96 hours post-dose; Dose 6/Week 20 pre-dose, post-dose, and 4, 24, 48 and 96 hours post-dose; 7, 14, and 21 days post-dose|Randomized participants who received at least 1 infusion of BG00002 and had at least 1 post-baseline assessment of BG00002 serum concentration; n = the number of these participants with an assessment at given timepoint.||hours||Full Range|Geometric Mean
691237|NCT01440101|Secondary|Part A: Pharmacokinetic (PK) Profile of Natalizumab in Serum: AUC(0-last) and (0-AUC∞)|Area under the curve to the last measurable concentration (AUC[0-last]); and area under the curve extrapolated to infinity (0-AUC∞) were calculated using non-compartmental methods.|Dose 1/Week 0: pre-dose, post-dose and 4, 24, 48 and 96 hours post-dose; Dose 6/Week 20 pre-dose, post-dose, and 4, 24, 48 and 96 hours post-dose; 7, 14, and 21 days post-dose|Randomized participants who received at least 1 infusion of BG00002 and had at least 1 post-baseline assessment of BG00002 serum concentration; n = the number of these participants with an assessment at given timepoint.||µg*h/mL||Full Range|Geometric Mean
691238|NCT01440101|Secondary|Part A: Pharmacokinetic (PK) Profile of Natalizumab in Serum: Cmax|Observed maximum concentration (Cmax) was calculated using non-compartmental methods.|Dose 1/Week 0: pre-dose, post-dose and 4, 24, 48 and 96 hours post-dose; Dose 6/Week 20 pre-dose, post-dose, and 4, 24, 48 and 96 hours post-dose; 7, 14, and 21 days post-dose|Randomized participants who received at least 1 infusion of BG00002 and had at least 1 post-baseline assessment of BG00002 serum concentration; n = the number of these participants with an assessment at given timepoint.||µg/mL||Full Range|Geometric Mean
691479|NCT01438229|Other Pre-specified|24hr Ambulatory Systolic BP Change|Average of readings taken every half hour during the course of a 24hr period wearing the ambulatory blood pressure monitor. Includes only subjects who completed the test at both baseline and follow up. If a subject refused to wear the monitor they were excluded.|Baseline to 12 months|||mmHg||Standard Deviation|Mean
691239|NCT01440101|Secondary|Part B: Concentration of Natalizumab in Serum|The concentration of BG00002 in serum was determined using an Enzyme Linked Immunosorbent Assay (ELISA).|Baseline (Week 0), Week 12, Week 24|Randomized participants who received at least 1 infusion of BG00002 and had at least 1 post-baseline assessment of BG00002 serum concentration; n = the number of these participants with an assessment at given timepoint. Participants with values <LLQ were not counted in the n for that timepoint.||µg/mL||Standard Deviation|Mean
691240|NCT01440101|Secondary|Part A: Concentration of Natalizumab in Serum|The concentration of BG00002 in serum was determined using an Enzyme Linked Immunosorbent Assay (ELISA).|Week 0: pre-dose, post-dose and 2, 24, 48 and 96 hours post-dose; 7, 14, and 21 days post-dose; Weeks 4, 8, 12, and 16: pre-dose; Week 20 pre-dose, post-dose, and 2, 24, 48 and 96 hours post-dose; 7, 14, 21, and 28 days post-dose|Participants who received at least 1 infusion of BG00002 with at least 1 post-baseline assessment of BG00002 serum concentration; n = the number of participants with an assessment at given timepoint. At Weeks 8, 12, and 16, one participant had values less than the lower limit of quantitation (<LLQ) and was not counted in the n for that timepoint.||µg/mL||Standard Deviation|Mean
691241|NCT01440101|Secondary|Part B: Change From Baseline to Weeks 12 and 24 in the Global Assessment of Well-Being As Assessed by Participants Using a Visual Analog Scale (VAS)|The participant's self-rating of global impression of his/her well-being was assessed with a VAS. The instrument ranged from 0 to 100 (mm), where a score of 0 denoted 'poor' and a score of 100 denoted 'excellent.'|Baseline (Week 0), Week 12, Week 24|n = all participants with an assessment at baseline and given timepoint.||units on a scale||Standard Deviation|Mean
691242|NCT01440101|Secondary|Part B: Number of Participants Who Were Relapse Free Over 24 Weeks|Participants were categorized as relapse free=yes, relapse free=no, or relapse free=unknown. The category of relapse free=unknown includes participants who withdrew from the study and did not experience a relapse prior to withdrawal.|Baseline (Week 0) to Week 24|All participants who received study drug.||participants|||Number
691243|NCT01440101|Secondary|Part B: Cumulative Number Of New Or Newly Enlarging, Non-Enhancing T2-Hyperintense Lesions Over 24 Weeks||Baseline (Week 0) to Week 24|Missing new Gd+ or new or newly-enlarging, non-enhancing T2 hyperintense lesions were imputed using linear interpolation between the 2 adjacent non-missing values. For participants who discontinued the study, linear interpolation reduced to last observation carried forward (LOCF) was used for imputing any remaining missing values.||lesions||Standard Deviation|Mean
691244|NCT01440101|Secondary|Part B: Cumulative Number of Gd+ Lesions Over 24 Weeks||Baseline (Week 0) to Week 24|Missing new Gd+ or new or newly-enlarging, non-enhancing T2 hyperintense lesions were imputed using linear interpolation between the 2 adjacent non-missing values. For participants who discontinued the study, linear interpolation reduced to last observation carried forward (LOCF) was used for imputing any remaining missing values.||lesions||Standard Deviation|Mean
691245|NCT01440101|Secondary|Part B: Adjusted Annualized Relapse Rate Over 24 Weeks|The frequency of clinical exacerbations over 24 weeks was assessed using an annualized relapse rate that was calculated for each treatment group as the total number of relapses experienced in the group over the 24 weeks of treatment, divided by the total number of subject-years followed in the study. Obtained from a Poisson regression model, adjusted for the baseline relapse rate.|Week 24|||relapses per year|Participants|95% Confidence Interval|Number
691246|NCT01440101|Secondary|Part B: Cumulative Number of New Active Lesions Over 24 Weeks||Baseline (Week 0) to Week 24|Missing new Gd+ or new or newly-enlarging, non-enhancing T2 hyperintense lesions were imputed using linear interpolation between the 2 adjacent non-missing values. For participants who discontinued the study, linear interpolation reduced to last observation carried forward (LOCF) was used for imputing any remaining missing values.||lesions||Standard Deviation|Mean
691247|NCT01440101|Primary|Part B: Rate of Development of New Active Lesions Over 24 Weeks|New active lesions were the sum of the gadolinium-enhancing (Gd+) lesions and any new or newly enlarging T2 hyperintense lesions that did not enhance as seen on cranial magnetic resonance imaging (MRI) scans. The rate is calculated for each participant as the ordinary least squares slope of the cumulative new active lesions over time.|Baseline (Week 0) to Week 24|Missing new Gd+ or new or newly-enlarging, non-enhancing T2 hyperintense lesions were imputed using linear interpolation between the 2 adjacent non-missing values. For participants who discontinued the study, linear interpolation reduced to last observation carried forward (LOCF) was used for imputing any remaining missing values.||lesions per week over 24 weeks||Standard Deviation|Mean
691248|NCT01440101|Primary|Part A: Number of Participants With Adverse Events (AEs)|AE=any untoward medical occurrence that did not necessarily have a causal relationship with this treatment. Serious AE (SAE)=any untoward medical occurrence that at any dose: resulted in death; in the view of the Investigator, was a life threatening event; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; or any other medically important event that, in the opinion of the Investigator, may have jeopardized the participant or may have required intervention to prevent one of the other outcomes listed in the definition above. Events were categorized as related or not related; severity was categorized as mild, moderate, or severe.|Baseline (Week 0) to Week 24|All participants who received study drug.||participants|||Number
691249|NCT01440049|Other Pre-specified|Percentage of Participants With Reason for Starting Eplerenone Treatment in FAS Population|Reasons for starting eplerenone treatment included myocardial infarction, heart failure and other conditions including severe hypertension by primary hyperaldosteronism; hypertension/coronaropathy and hypokalaemia; hypertension; left ventricular failure; not tolerated spironolactone; hypertension: gynecomastia with aldactone; pulmonary suboedema; hypertension: adrenal hyperplasia, gynecomastia with aldactone; hypertension not controlled.|Baseline|FAS population. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.||Percentage of participants||95% Confidence Interval|Number
691264|NCT01440049|Primary|Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 9 in FAS Population|Change of eplerenone dosage = modified dosage (mg daily) – dosage at start of treatment (mg daily). A positive change indicated dosage increase and a negative change indicated dosage decrease.|Baseline, Month 9|FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date. 'N' (number of participants analyzed)= participants evaluable for this measure.||Percentage of participants||95% Confidence Interval|Number
691250|NCT01440049|Other Pre-specified|Percentage of Participants With Signs of Cardiac Insufficiency in FAS Population|New York Health Association (NYHA) functional classification included: Class I (no limitation in physical activity, no dyspnea with normal activity), Class II (slight limitation of physical activity; fatigue, palpitation, or dyspnea with ordinary physical activity), Class III (marked limitation of physical activity; fatigue, palpitation, or dyspnea with less than ordinary physical activity) and Class IV (cannot perform a physical activity without any symptoms, dyspnea at rest). Percentage of participants in each functional class was reported.|Baseline, Months 3, 6, 9, 12|FAS population. Here 'n' is signifying those participants who were evaluable for this measure at given time point for each group respectively.||Percentage of participants||95% Confidence Interval|Number
691251|NCT01440049|Other Pre-specified|Change From Baseline in Maximum Value of Kalaemia Levels in FAS Population|The presence of excess potassium in the circulating blood is called hyperkalaemia. Normal potassium serum level is 3.5 to- 5.0 mmol/L. Change in maximum value kalaemia level was calculated by subtracting the baseline values from the maximum observed value of kalaemia levels during the study.|Baseline up to Month 12|FAS population. 'N' (number of participants analyzed)= participants evaluable for this measure. Here 'n' is signifying those participants who were evaluable for this measure at given time point for each group respectively.||mmol/L||Standard Deviation|Mean
691252|NCT01440049|Other Pre-specified|Maximum Kalaemia Levels in Serum in FAS Population|The presence of excess potassium in the circulating blood is called hyperkalaemia. Normal potassium serum level is 3.5 to- 5.0 mmol/L.|Baseline up to Month 12|FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date. 'N' (number of participants analyzed)= participants evaluable for this measure.||mmol/L||Standard Deviation|Mean
691253|NCT01440049|Other Pre-specified|Number of Measurements Per Month for Kalaemia Levels in FAS Population|The presence of excess potassium in the circulating blood is called hyperkalaemia. Normal potassium serum level is 3.5 to- 5.0 millimole per liter (mmol/L). Number of measurements per month for the kalaemia levels was reported.|Months 3, 6, 9, 12|FAS population. 'N' (number of participants analyzed)= participants evaluable for this measure. Here 'n' is signifying those participants who were evaluable for this measure at given time point for each group respectively.||Measurements per month||Standard Deviation|Mean
691254|NCT01440049|Other Pre-specified|Percentage of Participants With General Practitioner (GP) Consultation in FAS Population||Baseline up to Month 12|FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date.||Percentage of participants||95% Confidence Interval|Number
691255|NCT01440049|Other Pre-specified|Percentage of Participants With Other Notable Events in FAS Population|Other notable events included any clinically significant event other than death or hospitalization (example, ventricular tachycardia treated by defibrillator, imbalanced diabetes, work accident, right foot gout crisis, low back pain-oliguria, chest pain, bronchitis, renal failure, heart failure, hypotension, edema, standardization of gamma glutamyl transpeptidase (GT) after stopping lamisyl (peros) prescribed for a long term for mycosis, pain, nausea, fracture, trauma, gonarthrosis, increased urea, elevation of gamma GT etc.).|Baseline up to Month 12|FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date.||Percentage of participants||95% Confidence Interval|Number
691256|NCT01440049|Secondary|Percentage of Participants Who Discontinued Eplerenone Treatment in FAS Population||Baseline up to Month 12|FAS population. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.||Percentage of participants||95% Confidence Interval|Number
691257|NCT01440049|Secondary|Number of Participants With Concomitant Cardiovascular Treatment in SAS Population|Concomitant cardiovascular treatment included any cardiovascular treatment other than, and in addition to, the study treatment taken at any time during the study.|Baseline up to Month 12|SAS population included all participants who received study medication.||Participants|||Number
691258|NCT01440049|Secondary|Number of Participants With Concomitant Cardiovascular Treatment in FAS Population|Concomitant cardiovascular treatment included any cardiovascular treatment other than, and in addition to, the study treatment taken at any time during the study.|Baseline up to Month 12|FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date.||Participants|||Number
691259|NCT01440049|Secondary|Number of Participants With Reason for Increased or Decreased Eplerenone Dose||Baseline up to Month 12|Data were not statistically summarized and were provided in individual participant listings as per the planned analysis.|||||
691260|NCT01440049|Primary|Number of Participants With Worsened Renal Function||Baseline up to Month 12|Data were not analyzed because the assessment of renal function was not included in the planned analysis of this study.|||||
691261|NCT01440049|Primary|Percentage of Participants Hospitalized in FAS Population||Baseline up to Month 12|FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date. 'N' (number of participants analyzed)= participants evaluable for this measure.||Percentage of participants||95% Confidence Interval|Number
691262|NCT01440049|Primary|Percentage of Participants Who Died in SAS Population||Baseline up to Month 12|SAS population included all participants who received study medication. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.||Percentage of participants||95% Confidence Interval|Number
691263|NCT01440049|Primary|Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 12 in FAS Population|Change of eplerenone dosage = modified dosage (mg daily) – dosage at start of treatment (mg daily). A positive change indicated dosage increase and a negative change indicated dosage decrease.|Baseline, Month 12|FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date. 'N' (number of participants analyzed)= participants evaluable for this measure.||Percentage of participants||95% Confidence Interval|Number
691265|NCT01440049|Primary|Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 6 in FAS Population|Change of eplerenone dosage = modified dosage (mg daily) – dosage at start of treatment (mg daily). A positive change indicated dosage increase and a negative change indicated dosage decrease.|Baseline, Month 6|FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date. 'N' (number of participants analyzed)= participants evaluable for this measure.||Percentage of participants||95% Confidence Interval|Number
691266|NCT01440049|Primary|Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 3 in FAS Population|Change of eplerenone dosage = modified dosage (mg daily) – dosage at start of treatment (mg daily). A positive change indicated dosage increase and a negative change indicated dosage decrease.|Baseline, Month 3|FAS population. Here 'n' is signifying those participants who were evaluable for this measure at given time point for each group respectively.||Percentage of participants||95% Confidence Interval|Number
691267|NCT01440049|Primary|Percentage of Participants With Eplerenone Treatment Compliance at Month 12 in FAS Population|Participants receiving eplerenone on the basis of the approved SmPC were said to be treatment compliant.|Month 12|FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date. 'N' (number of participants analyzed)= participants evaluable for this measure.||Percentage of participants||95% Confidence Interval|Number
691268|NCT01440049|Primary|Percentage of Participants With Eplerenone Treatment Compliance at Month 9 in FAS Population|Participants receiving eplerenone on the basis of the approved SmPC were said to be treatment compliant.|Month 9|FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date. 'N' (number of participants analyzed)= participants evaluable for this measure.||Percentage of participants||95% Confidence Interval|Number
691269|NCT01440049|Primary|Percentage of Participants With Eplerenone Treatment Compliance at Month 6 in FAS Population|Participants receiving eplerenone on the basis of the approved SmPC were said to be treatment compliant.|Month 6|FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date. 'N' (number of participants analyzed)= participants evaluable for this measure.||Percentage of participants||95% Confidence Interval|Number
691270|NCT01440049|Primary|Percentage of Participants With Eplerenone Treatment Compliance at Month 3 in FAS Population|Participants receiving eplerenone on the basis of the approved summary of product characteristics (SmPC) were said to be treatment compliant.|Month 3|FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date. 'N' (number of participants analyzed)= participants evaluable for this measure.||Percentage of participants||95% Confidence Interval|Number
691271|NCT01440049|Primary|Systolic Ejection Fraction as a Measure of Left Ventricular Dysfunction at Inclusion for Safety Analysis Set (SAS) Population|Left ventricular dysfunction, a condition in which the left ventricle of the heart exhibits a decreased functionality, was assessed based on systolic ejection fraction. Systolic ejection fraction was the fraction of the end-diastolic volume (EDV) that was ejected out of left ventricle with each contraction.|Baseline|SAS population included all participants who received study medication. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.||Percentage of EDV||Standard Deviation|Mean
691272|NCT01440049|Primary|Systolic Ejection Fraction as a Measure of Left Ventricular Dysfunction at Inclusion for Full Analysis Set (FAS) Population|Left ventricular dysfunction, a condition in which the left ventricle of the heart exhibits a decreased functionality, was assessed based on systolic ejection fraction. Systolic ejection fraction was the fraction of the end-diastolic volume (EDV) that was ejected out of left ventricle with each contraction.|Baseline|FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date. 'N' (number of participants analyzed)= participants evaluable for this measure.||Percentage of EDV||Standard Deviation|Mean
691273|NCT01439971|Secondary|Maximum Mean Increase From Baseline in Peak Thrombin Generation|The peak height is defined as the maximum thrombin concentration produced. Maximum mean increase from baseline at any time point was reported.|Baseline through Day 3|The safety population included all enrolled participants who received the study drug. The 'Number of Participants Analyzed' is the number of evaluable participants for this measure.||Nanomolar (nM)||Standard Deviation|Mean
691274|NCT01439971|Secondary|Maximum Mean Decrease From Baseline in Thrombin Generation Lag Time|The lag time is defined as the time to reach one sixth of the peak height and is a measure of the initiation phase. It is equivalent to the clotting time. Maximum mean decrease from baseline at any time point was reported.|Baseline through Day 3|The safety population included all enrolled participants who received the study drug. The 'Number of Participants Analyzed' is the number of evaluable participants for this measure.||minutes||Standard Deviation|Mean
691275|NCT01439971|Secondary|Maximum Mean Increase From Baseline in Endogenous Thrombin Potential (ETP)|ETP was evaluated using a Thrombin Generation Assay (TGA), a validated automated ex-vivo assay that measures the ability of plasma to generate thrombin. Thrombin generation curves are generated and calculated using dedicated software. ETP is the area under the thrombin generation curve and represents the total amount of generated thrombin. Maximum mean increase from baseline at any time point was reported.|Baseline through Day 3|The safety population included all enrolled participants who received the study drug. The 'Number of Participants Analyzed' is the number of evaluable participants for this measure.||nanomolar*minute (nM*min)||Standard Deviation|Mean
691276|NCT01439971|Secondary|Maximum Mean Increase From Baseline in D-Dimers|D-dimer is an indicator of fibrin formation and its subsequent lysis and is a useful biomarker representing overall activation of blood coagulation. Maximum mean increase from baseline at any time point was reported.|Baseline through Day 15|The safety population included all enrolled participants who received the study drug.||ng/mL||Standard Deviation|Mean
691277|NCT01439971|Secondary|Maximum Mean Increase From Baseline in Prothrombin Fragments 1+2|Prothrombin fragment 1+2 is a coagulation factor, released when prothrombin is cleaved by activated Factor X. Elevated plasma levels of prothrombin fragment 1+2 indicate high risk of thrombosis. Maximum mean increase from baseline at any time point was reported.|Baseline through Day 3|The safety population included all enrolled participants who received the study drug. The 'Number of Participants Analyzed' is the number of evaluable participants for this measure.||picomoles per liter (pmol/L)||Standard Deviation|Mean
691278|NCT01439971|Secondary|Maximum Mean Increase From Baseline in Thrombin Anti-Thrombin (TAT) Complexes|TAT complex is a parameter of coagulation and fibrinolysis. The normal reference range of values for TAT is 1 to 4.1 mcg/L. Elevated TAT concentrations may signify predisposition to thrombosis. Maximum mean increase from baseline at any time point was reported.|Baseline through Day 3|The safety population included all enrolled participants who received the study drug. The 'Number of Participants Analyzed' is the number of evaluable participants for this measure.||mcg/L||Standard Deviation|Mean
691279|NCT01439971|Secondary|Maximum Mean Decrease From Baseline in Activated Partial Thromboplastin Time (aPTT)|aPTT is a blood test that characterizes blood coagulation. Maximum mean decrease from baseline at any time point was reported.|Baseline through Day 15|The safety population included all enrolled participants who received the study drug.||seconds||Standard Deviation|Mean
691280|NCT01439971|Secondary|Maximum Mean Decrease From Baseline in Prothrombin Time (PT)|PT measures how long it takes blood to clot. Maximum mean decrease from baseline at any time point was reported.|Baseline through Day 15|The safety population included all enrolled participants who received the study drug.||seconds||Standard Deviation|Mean
691281|NCT01439971|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||Day 1 (pre-dose and 5 min, 10 min, 20 min, 30 min, 1 hr, 3 hr, 6 hr, 9 hr, and 12 hrs post-dose), Day 2 (24 hrs post-dose), Day 3 (48 hrs post-dose)|The PK parameter analysis population included enrolled and treated participants who had at least 1 of the PK parameters of interest.||hours||Full Range|Median
691282|NCT01439971|Secondary|Clearance (CL)|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes). Clearance obtained after intravenous infusion dose is influenced by the fraction of the dose absorbed.|Day 1 (pre-dose and 5 min, 10 min, 20 min, 30 min, 1 hr, 3 hr, 6 hr, 9 hr, and 12 hrs post-dose), Day 2 (24 hrs post-dose), Day 3 (48 hrs post-dose)|The PK parameter analysis population included enrolled and treated participants who had at least 1 of the PK parameters of interest.||L/hr/kg||Geometric Coefficient of Variation|Geometric Mean
691283|NCT01439971|Secondary|Volume of Distribution at Steady State (Vss)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.|Day 1 (pre-dose and 5 min, 10 min, 20 min, 30 min, 1 hr, 3 hr, 6 hr, 9 hr, and 12 hrs post-dose), Day 2 (24 hrs post-dose), Day 3 (48 hrs post-dose)|The PK parameter analysis population included enrolled and treated participants who had at least 1 of the PK parameters of interest.||L/kg||Geometric Coefficient of Variation|Geometric Mean
691284|NCT01439971|Secondary|Mean Residence Time (MRT)|MRT is AUMCinf/AUCinf, where AUMC is the area under the first moment curve.|Day 1 (pre-dose and 5 min, 10 min, 20 min, 30 min, 1 hr, 3 hr, 6 hr, 9 hr, and 12 hrs post-dose), Day 2 (24 hrs post-dose), Day 3 (48 hrs post-dose)|The PK parameter analysis population included enrolled and treated participants who had at least 1 of the PK parameters of interest.||hours||Standard Deviation|Mean
691285|NCT01439971|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)|AUCinf is area under the plasma concentration-time curve from time 0 extrapolated to infinite time.|Day 1 (pre-dose and 5 min, 10 min, 20 min, 30 min, 1 hr, 3 hr, 6 hr, 9 hr, and 12 hrs post-dose), Day 2 (24 hrs post-dose), Day 3 (48 hrs post-dose)|The PK parameter analysis population included enrolled and treated participants who had at least 1 of the PK parameters of interest.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
691286|NCT01439971|Secondary|Incremental Recovery (IncRec)|IncRec is the maximum rise in plasma concentration per administered dose.|Day 1 (pre-dose and 5 min, 10 min, 20 min, 30 min, 1 hr, 3 hr, 6 hr, 9 hr, and 12 hrs post-dose), Day 2 (24 hrs post-dose), Day 3 (48 hrs post-dose)|The PK parameter analysis population included enrolled and treated participants who had at least 1 of the PK parameters of interest.||ng/mL/mcg/kg||Geometric Coefficient of Variation|Geometric Mean
691287|NCT01439971|Secondary|Terminal Elimination Half-Life (t1/2)|t1/2 is the time measured for the plasma concentration to decrease by one half.|Day 1 (pre-dose and 5 min, 10 min, 20 min, 30 min, 1 hr, 3 hr, 6 hr, 9 hr, and 12 hrs post-dose), Day 2 (24 hrs post-dose), Day 3 (48 hrs post-dose)|The PK parameter analysis population included enrolled and treated participants who had at least 1 of the PK parameters of interest.||hour||Standard Deviation|Mean
691288|NCT01439971|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|Day 1 (pre-dose and 5 min, 10 min, 20 min, 30 min, 1 hr, 3 hr, 6 hr, 9 hr, and 12 hrs post-dose), Day 2 (24 hrs post-dose), Day 3 (48 hrs post-dose)|The PK parameter analysis population included enrolled and treated participants who had at least 1 of the PK parameters of interest.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
691289|NCT01439971|Secondary|Maximum Observed Plasma Concentration (Cmax)||Day 1 (pre-dose and 5 min, 10 min, 20 min, 30 min, 1 hr, 3 hr, 6 hr, 9 hr, and 12 hrs post-dose), Day 2 (24 hrs post-dose), Day 3 (48 hrs post-dose)|The PK parameter analysis population included enrolled and treated participants who had at least 1 of the PK parameters of interest.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
691290|NCT01439971|Primary|Number of Participants With Positive Immune Response (Anti-Drug Antibodies [ADA], PF-05280602 Inhibitor, Factor VIIa Inhibitor, Factor VII Inhibitor, and Depletion of Factor VII Activity)|Assays for the determination of a positive immune response was performed. An antibody immune response was defined as a confirmed post-treatment positive ELISA result in combination with a negative baseline sample ELISA result. Positive antibody immune responses to PF-05280602 by ELISA was evaluated for cross reactivity to NovoSeven RT and to Factor VII.|Baseline through Day 60|The immunogenicity parameter population included enrolled and treated participants with at least 1 post-treatment anti-PF-05280602 antibody (ADA), PF-05280602 inhibitor, or Factor VII activity level determination.||participants|||Number
733990|NCT00424190|Secondary|Clinical and Microbiological Response by Pathogen at the TOC Visit||8-15 days after last dose of study drug||||||
691291|NCT01439971|Primary|Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria|Clinically significant findings for stopping rules are: hemoglobin <8 grams/deciliter (g/dL) or >20% decrease from normal baseline; WBC >20,000 cells/mm^3 or <1,500 decrease with normal baseline; platelets <100,000/mm^3 or >33% decrease from baseline; total bilirubin >1.5X ULN; AST or ALT >2.5X ULN; alkaline phosphatase >3X ULN; creatinine >1.5X baseline; BUN >31.0 mg/dL; glucose <0.6 or >1.5X reference range; uric acid > ULN; sodium >150 or <130 mEq/L; potassium >5.5 or <3.0 mEq/L; calcium >11.5 or <8.0 mg/dL; albumin <2.0 g/L; total protein <5.0 g/L; positive D-dimer at Day 15; PT prolonged by 3 seconds above baseline; ATIII < LLN and >20% decrease from baseline; troponin-T values above the reference range; fibrinogen <0.75X LLN or >25% decrease from baseline.|Baseline through Day 15|The safety population included all enrolled participants who received the study drug.||participants|||Number
691292|NCT01439971|Primary|Number of Participants With Treatment-Emergent Laboratory Test Abnormalities (Normal Baseline)|The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell [RBC] count, platelets, leukocytes, total neutrophils, eosinophils, basophils, lymphocytes, monocytes); chemistry (total bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase [AST], alanine aminotransferase [ALT], alkaline phosphatase, creatinine, blood urea nitrogen [BUN], glucose, uric acid, sodium, potassium, chloride, bicarbonate, calcium, albumin, total protein, creatine kinase); urinalysis (urine white blood cell [WBC], urine RBC); other (troponin T).|Baseline through Day 15|The safety population included all enrolled participants who received the study drug.||participants|||Number
691293|NCT01439971|Primary|Number of Participants With Treatment-Emergent Abnormal Tissue Factor Pathway Inhibitor (TFPI) Levels by Magnitude|TFPI is a polypeptide that can regulate blood coagulation. TFPI levels of potential clinical concern are values <1X LLN and >1X ULN.|Baseline through Day 3|The safety population included all enrolled participants who received the study drug.||participants|||Number
691294|NCT01439971|Primary|Number of Participants With Treatment-Emergent Abnormal Anti-Thrombin III (ATIII) Levels by Magnitude|ATIII is a protein in the blood that blocks abnormal blood clots from forming. Low levels of ATIII can cause abnormal blood clots. ATIII levels of potential clinical concern are values <1X LLN and >1X ULN.|Baseline through Day 3|The safety population included all enrolled participants who received the study drug.||participants|||Number
691295|NCT01439971|Primary|Number of Participants With Treatment-Emergent Abnormal Troponin-T Levels by Magnitude|Troponin-T is a cardiac marker for the evaluation of possible cardiovascular injury. Troponin-T levels of potential clinical concern are values >1.5 times the upper limit of normal (1.5X ULN) or >=2.5X ULN.|Baseline through Day 15|The safety population included all enrolled participants who received the study drug.||participants|||Number
691296|NCT01439971|Primary|Number of Treatment-Emergent Hemophilia AEs by Severity|Mild severity AEs do not interfere with the participant's usual function. Moderate AEs interfere to some extent with the participant's usual function. Severe AEs interfere significantly with the participant's usual function.|Baseline through Day 60|The safety population included all enrolled participants who received the study drug.||adverse events|||Number
691297|NCT01439971|Primary|Number of Treatment-Emergent AEs and SAEs by Severity (Except Hemophilia AEs)|AE severity were graded as mild, moderate, or severe. Mild severity AEs do not interfere with the participant's usual function. Moderate AEs interfere to some extent with the participant's usual function. Severe AEs interfere significantly with the participant's usual function.|Baseline through Day 60|The safety population included all enrolled participants who received the study drug.||adverse events|||Number
691298|NCT01439971|Primary|Number of Participants With Treatment-Emergent Hemophilia AEs and Withdrawals Due to Hemophilia AEs|Hemophilia AEs included spontaneous (no known contributing factor) and traumatic (known or presumed contributing factor/reason) bleeding episodes.|Baseline through Day 60|The safety population included all enrolled participants who received the study drug.||participants|||Number
691299|NCT01439971|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Withdrawals Due to AEs (Except Hemophilia AEs)|An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Day 15 that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.|Baseline through Day 60|The safety population included all enrolled participants who received the study drug.||participants|||Number
691300|NCT01439971|Primary|Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings|ECG findings of potential clinical concern were: PR interval greater than or equal to (>=)300 milliseconds (msec), >=25% increase from baseline for baseline values >200 msec, >=50% increase from baseline for baseline values less than or equal to (<=)200 msec; QRS complex >=140 msec or >=50% increase from baseline; QTcF interval (Fridericia's correction) >=450 msec or >=30 msec increase from baseline.|Baseline through Day 15|The safety population included all enrolled participants who received the study drug.||participants|||Number
691301|NCT01439971|Primary|Number of Participants With Changes Since Previous Physical Examination|Physical examinations were conducted by a physician, trained physician's assistant, or nurse practitioner. A complete physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, genitourinary, gastrointestinal, musculoskeletal, and neurological systems. The limited or abbreviated physical examination focused on general appearance, the respiratory and cardiovascular systems, as well as towards participant reported symptoms.|Baseline (Day 0), Day 1, Day 2, Day 3, Day 15|The safety population included all enrolled participants who received the study drug.||participants|||Number
691302|NCT01439971|Primary|Change From Baseline in Supine Pulse Rate|Change from baseline is the vital sign value at Day 2, Day 3, and Day 15 minus vital sign value at baseline.|Baseline, Day 2, Day 3, and Day 15|The safety population included all enrolled participants who received the study drug.||beats per minute (bpm)||Standard Deviation|Mean
691303|NCT01439971|Primary|Change From Baseline in Respiration Rate|Respiration rate measured as respirations per minute (resp/min).|Baseline, Day 2, Day 3, and Day 15|The safety population included all enrolled participants who received the study drug.||resp/min||Standard Deviation|Mean
694332|NCT01402102|Secondary|Changes in Apo-B(Apolipoprotein B)|Apo-B(Apolipoprotein B) was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis||g/L||Standard Deviation|Mean
691306|NCT01439971|Primary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Supine blood pressure (BP) was measured with the participant’s arm supported at the level of the heart, and recorded to the nearest millimeters of mercury (mmHg) after 5 minutes of rest. The same arm (preferably the dominant arm) was to be used throughout the study.|Baseline, Day 2, Day 3, and Day 15|The safety population included all enrolled participants who received the study drug.||mmHg||Standard Deviation|Mean
691307|NCT01439945|Secondary|The Intra-patient Changes of Magnesium Level From Baseline to the End of Treatment Period Between Magnesium Oxide and Placebo Arms.|"The intra-patient changes of magnesium level from baseline to the end of treatment period between magnesium oxide and placebo arms will be compared using a repeated measures model.
Serum magnesium concentrations will be performed prior to study medication usage and during the last week of blinded study use. These will be obtained in the first 150 patients. Mean change in serum magnesium concentrations will be compared between the 3 study arms to determine whether there are any apparent changes in the patients receiving placebos vs the two magnesium doses."|Baseline to week 8|All patients that started protocol treatment and had serum magnesium levels obtained at baseline and week 9 were included in this analysis.||mg/dL||Standard Deviation|Mean
691308|NCT01439945|Secondary|The Change of Daily Interference as Measured by the Hot Flash Related Daily Interference Scale (HFRDIS) From Baseline to Treatment Termination.|"We will use the Hot Flash Related Daily Interference Scale (HFRDIS) (SEQ) to evaluate the specific effect of hot flashes have on various life activities such as work, social, leisure and relationships while receiving treatment. The questionnaire is 10 questions and is based on a 0=Do not interfere to 10=Completely interfere scale. The weekly score is the summation of these 10 questions and therefore ranges from 0 to 100. The total change in severity of symptoms is calculated by subtracting the week 8 score from the baseline. Therefore, values below zero indicate a worsening of symptoms and values above zero indicate an improvement and has a maximum range of -100 to 100. A gatekeeper procedure, following a fixed-sequence hypothesis testing method, was used to examine the higher dose of magnesium vs. placebo first and then the lower dose of magnesium vs. placebo, if the former was statistically significant."|Baseline to week 8|All patients that began treatment and completed the HFRDI questionnaire at baseline and week 8 were used in this analysis.||units on a scale||Full Range|Median
691309|NCT01439945|Secondary|The Change of Severity of Symptoms as Measured the Symptom Experience Questionnaire From Baseline to Treatment Termination|"We will use the Symptom Experience Questionnaire (SEQ) to evaluate the specific impact of the study treatment on the effect hot flashes have on various life activities such as work, social, leisure and relationships. The questionnaire is 14 questions and is based on a 0=Not at all to 10=As bad as it can be scale. The change of severity of symptoms as measured by the SEQ from baseline to treatment termination will be first summarized by descriptive statistics as a percent change from baseline."|Baseline to week 8|All patients that started treatment and completed the Symptom Experience Questionnaire at baseline and Cycle 9 were included in this analysis.||percentage change||Full Range|Median
691310|NCT01439945|Secondary|Frequency and Maximum Grade of Adverse Events Reported Via the CTCAE 4.0 During the Treatment Period.|Frequency and severity of adverse events reported by patients in weekly Symptom Experience Questionnaire and evaluated through clinical assessment by NCI CTCAE v3.0. The number of patients reporting grade 3 or higher events are reported in this outcome measure. For a full list of all events, please refer to the Adverse Events section of this report.|Baseline to Week 8|All patients that started protocol treatment and were evaluated for adverse events are included in this analysis.||Participants|||Count of Participants
691311|NCT01439945|Secondary|Weekly Frequency of Hot Flashes as Measured by the Hot Flash Diary During the Treatment Period|As part of the Hot Flash Diary, the number of hot flashes was recorded for each patient for each week. For this endpoint, the mean number of hot flashes for each group is reported. A repeated measure analysis comparing each dose level group and the Placebo is reported.|Baseline to Week 8|All patients that began protocol treatment and completed the Hot Flash Diary were included in this analysis.||number of hot flashes||Standard Deviation|Mean
691312|NCT01439945|Primary|The Intra-patient Changes of Weekly Hot Flash Activity From Baseline During the Treatment Period.|"The primary endpoint is the intra-patient changes of weekly hot flash activity from baseline during the treatment period. The hot flash activity will be measured by the weekly average hot flash score, which is a composite entity of both frequency and severity of hot flashes.
The hot flash severity is graded from 1 to 4 (1=mild, 2=moderate, 3=severe, and 4=very severe). The daily hot flash score is computed by multiplying the mean grade of severity by the frequency during every 24 hour period. Therefore, a score of zero is the lowest possible score and can be interpreted as having no hot flashes. The weekly hot flash score was calculated by adding all scores for the week.
The mean Hot Flash Score for each week for each group is reported and a repeated measures analysis is reported comparing each dose level group to the Placebo group."|Baseline to Week 8|All patients that began protocol treatment and completed the Hot Flash Diary were included in this analysis.||units on a scale||Standard Deviation|Mean
691313|NCT01439867|Secondary|Dose- and Weight-Normalized Area Under the Plasma Concentration-time Curve From Time 0 to the Time of Last Quantifiable Concentration (AUClast) for Cinacalcet||Week 12|The Pharmacokinetic/ Pharmacodynamic (PK/PD) analysis set includes all participants who received at least one dose of study drug and had at least one evaluable PK parameter.||hr*ng/mL/(mgkg)||Standard Deviation|Mean
691314|NCT01439867|Secondary|Dose- and Weight-Normalized Maximum Plasma Concentration (Cmax) of Cinacalcet||Week 12|The Pharmacokinetic/ Pharmacodynamic (PK/PD) analysis set includes all participants who received at least one dose of study drug and had at least one evaluable PK parameter.||ng/mL/(mgkg)||Standard Deviation|Mean
691315|NCT01439867|Secondary|Percentage of Participants Who Achieved iPTH Values < 300 pg/mL During the Study|A participant was considered to have achieved iPTH < 300 pg/mL (31.8 pmol/L) during the study if any post-baseline iPTH value was < 300 pg/mL.|26 weeks|The analysis included all enrolled subjects with at least 1 post-baseline assessment (full analysis set).||percentage of participants||90% Confidence Interval|Number
691350|NCT01439282|Secondary|Number of Patients With Adverse Events of 4 Cycles of Eribulin Plus Capecitabine in the Adjuvant Setting|"Safety will be assessed by the monitoring and recording all AEs and serious adverse events (SAEs), regular monitoring of hematology and clinical chemistry, vital signs, electrocardiograms (ECGs), Eastern Cooperative Oncology Group (ECOG) performance status, regular physician assessments, concomitant medications, medical histories, and physical examinations.
Not posted. Treatment-emergent adverse events (TEAEs) and SAEs will be reported with the AEs and SAEs."|12 weeks||||||
691316|NCT01439867|Secondary|Percentage of Participants Who Achieved iPTH Values Between 200 and 300 pg/mL at Any Two Consecutive Measurements|A participant was considered to have achieved iPTH between 200 and 300 pg/mL (21.2 and 31.8 pmol/L) at any 2 consecutive measurements if any two consecutive post-baseline iPTH values were within the range regardless if there was a missing value in between. The analysis included all enrolled subjects with at least 1 post-baseline assessment.|26 weeks|The analysis included all enrolled participants with at least 1 post-baseline assessment (full analysis set).||percentage of participants||90% Confidence Interval|Number
691317|NCT01439867|Secondary|Percentage of Participants Who Achieved ≥ 30% Reduction in iPTH From Baseline During the Study|A participant was considered to have achieved ≥ 30% reduction in iPTH if the percent change of any post-baseline iPTH value was ≤ -30% from baseline.|26 weeks|The analysis included all enrolled participants with at least 1 post-baseline assessment (full analysis set).||percentage of participants||90% Confidence Interval|Number
691318|NCT01439867|Secondary|Percentage of Participants Who Achieved > 30% Reduction in iPTH From Baseline at Any Two Consecutive Measurements|A participant was considered to have achieved > 30% reduction in iPTH from baseline at any 2 consecutive measurements if percent change of any two consecutive post-baseline iPTH values were < -30% regardless if there was a missing value in between.|26 weeks|The analysis included all enrolled participants with at least 1 post-baseline assessment (full analysis set).||percentage of participants||90% Confidence Interval|Number
691319|NCT01439867|Secondary|Percent Change From Baseline in Calcium Phosphorus Product (Ca x P)||Baseline and weeks 3, 7, 11, 15, 19, 22, and 24|The analysis included all enrolled participants with at least 1 post-baseline assessment (full analysis set) and with available data at each time point.||percent change||Standard Deviation|Mean
691320|NCT01439867|Secondary|Percent Change From Baseline in Serum Phosphorous||Baseline and weeks 3, 7, 11, 15, 19, 22, and 24|The analysis included all enrolled participants with at least 1 post-baseline assessment (full analysis set) and with available data at each time point.||percent change||Standard Deviation|Mean
691321|NCT01439867|Secondary|Percent Change From Baseline in Corrected Serum Calcium||Baseline and weeks 3, 7, 11, 15, 19, 22, and 24|The analysis included all enrolled participants with at least 1 post-baseline assessment (full analysis set) and with available data at each time point.||percent change||Standard Deviation|Mean
691322|NCT01439867|Secondary|Percent Change From Baseline in Intact Parathyroid Hormone (iPTH)||Baseline and weeks 3, 7, 11, 15, 19, 22, and 24|The analysis included all enrolled participants with at least 1 post-baseline assessment (full analysis set) and with available data at each time point.||percent change||Standard Deviation|Mean
691323|NCT01439867|Secondary|Percentage of Participants With Corrected Serum Calcium Levels < 8.8 mg/dL (2.2 mmol/L) During the Study||26 weeks|The analysis included participants who received at least 1 dose of cinacalcet and had at least 1 measured serum calcium value while on cinacalcet (calcium analysis set).||percentage of participants||90% Confidence Interval|Number
691324|NCT01439867|Primary|Percentage of Participants With Hypocalcemia|Hypocalcemia was defined as corrected serum calcium levels < 9.0 mg/dL (2.25 mmol/L) for participants aged 28 days to < 2 years, and < 8.4 mg/dL (2.1 mmol/L) for participants aged ≥ 2 years to < 6 years at any time during the study.|26 weeks|The analysis included participants who received at least 1 dose of cinacalcet and had at least 1 measured serum calcium value while on cinacalcet (calcium analysis set).||percentage of participants||90% Confidence Interval|Number
691325|NCT01439724|Secondary|Oral Mucositis Survival Free, Pain, Opioid Treatment, Hospitalization, Treatment Interruption, Treatment Delay, Patient Weight Loss, Nasogastric Tube or of a Gastrostomy.|Oral mucositis survival free, pain, opioid treatment, hospitalization, treatment interruption, treatment delay, patient weight loss, nasogastric tube or of a gastrostomy.The oral cavities of all patients were evaluated, from the first day to the last day of treatment.|7 weeks||||||
691326|NCT01439724|Primary|Incidence and / or Severity of Oral Mucositis|The oral cavities of all patients were evaluated daily, from the first day until the last day of treatment. We used the scales of mucositis of the World Health Organization (WHO) and the Oral Mucositis Assessment Scale (OMAS) and a visual analogue scale (VAS) for pain assessment.|7 weeks|Data related to the primary endpoint were handled in a per protocol treatment analysis.||Grade 3-4 oral mucositis|||Number
691327|NCT01439672|Primary|Insulin Sensitivity|Measure insulin sensitivity following a mixed meal across admissions. Insulin sensitivity was measured based on the minimal model of glucose kinetics using plasma glucose and insulin obtained frequently (approximately every 5-15 minutes) in response to mixed meal challenge.|24 hours|||1/min per uU/mL||Standard Deviation|Mean
694333|NCT01402102|Secondary|Changes in Apo-A1(Apolipoprotein A1)|Apo-A1(Apolipoprotein A1) was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis||g/L||Standard Deviation|Mean
691451|NCT01438307|Secondary|Number of Patients With Any Graded Adverse Event|Safety will be assessed using the National Cancer Institute Common Toxicity Criteria (Version 4.0) and all adverse events will be recorded prior to each treatment regimen.|Baseline up to 28 months|14 patients in each cohort were included in the toxicity assessment and 13 patients in each cohort in the efficacy assessment.||Participants|||Count of Participants
691452|NCT01438307|Secondary|Progression Free Survival|Progression Free Survival is defined from the initiation of treatment until radiological-clinical evidence of progression according to the RECIST (v 1.1).|Baseline up to 28 months|||months||95% Confidence Interval|Median
733991|NCT00424190|Secondary|Clinical Response at the End of Therapy (EOT) Visit||Last day of study drug administration||||||
691351|NCT01439282|Secondary|Use of Cold Cap for Alopecia|Alopecia (hair loss) is a potential side effect of some chemotherapy agents. Chemotherapeutic drugs are toxic and could potentially harm the hair follicles (wear hair grows from) resulting in the hair falling out. It can occur in small patches on various parts of the body or all over the body and is usually temporary when related to cancer treatment. Cold cap therapy is one form of therapy for alopecia involving hair loss from the scalp. Wearing a cap or head covering with cold packs before, during, or after chemotherapy may help prevent hair loss as the cold narrows the blood vessels in the skin on your head which may lead to less of the drug reaching the hair follicles. Alopecia was one of the most common adverse events (AEs) related to eribulin only.|On the day of study drug infusion treatments during Cycles 1 through 4|Safety analysis set included all participants who received at least one dose of study treatments and had at least one postbaseline safety assessment.||Participants|||Number
691352|NCT01439282|Primary|Percentage of Participants Who Achieved the Target Relative Dose Intensity (RDI) of 85%|Relative Dose Intensity (RDI) is defined as the amount of drug administered over a specific time and is expressed as the fraction of that recommended for standard of care. The RDI for each participant was calculated as follows: (1) based on each participant’s body surface area (BSA), a total planned dose for both eribulin (Dep) and capecitabine (Dcp) calculated for a full 4-cycle regimen; (2) actual total dose of eribulin (Dea) and capecitabine (Dca) for the full 4-cycle regimen as collected on the case report form; (3) overall RDI = (Dea/Dep + Dca/Dcp)/2. For each individual participant, the regimen was considered feasible if that participant was able to achieve an RDI of at least 85% of the 4 cycles of eribulin plus capecitabine treatment. Missing doses due to any reason was counted as zero in the RDI calculation.|21-Day Cycle 1 through 21-Day Cycle 4|Full analysis set included all participants who received at least one dose of eribulin mesylate plus capecitabine.||Percentage of participants||95% Confidence Interval|Number
691353|NCT01439204|Secondary|Number of Participants With a Change From Baseline in QT Interval and Corrected (Fridericia) QT Interval (QTcF) - Safety Population|12-lead electrocardiograms were performed on a supine participant (5 minutes supine) at baseline (baseline = screening; Days -21 to -2) and at Day 71. QT interval and QTc were measured in mille seconds (msec). A change from baseline QT and QTc (corrected for heart rate by Fridericia formula) greater than (>) 30 msec or less than (<) 60 msec were presented, as well as values over 450 and 500 msec. QT interval on ECG image defined as: time from the beginning of the QRS (complex consisting of Q, R and S waves) to the end of the T wave.|Day 1 to Day 71|All participants who received study drug and had at least one ECG value.||participants|||Number
691354|NCT01439204|Secondary|Change From Baseline in Diastolic Blood Pressure on Days 1, 2, 15, 29, 57, and 71 - Safety Population|Blood pressure was obtained while the participant had been quietly seated for at least 5 minutes. Baseline was the 0 hour measurement on Day 1 (day of dosing) or if this value was missing, the last measurement before dosing. Blood pressure was measured in millimeters of mercury (mmHg) on Days 1, 2, 15, 29, 57, and 71.|Day 1 to Day 71|All participants who received study drug (safety population) and had diastolic assessment were included in the analysis. Day 2 N=36 both arms; Day 15 (Lonza arm N=36; Devens arm N=34; Day 29 (N=33 in both arms); Day 57 (Lonza arm N=31; Devens arm N=33); Day 71 (Lonza arm N=36; Devens arm N=34).||mmHg||Standard Deviation|Mean
691355|NCT01439204|Secondary|Change From Baseline in Systolic Blood Pressure - Safety Population|Blood pressure was obtained while the participant had been quietly seated for at least 5 minutes. Baseline was the 0 hour measurement on Day 1 (day of dosing) or if this value was missing, the last measurement before dosing. Blood pressure was measured in millimeters of mercury (mmHg) on Days 1, 2, 15, 29, 57, and 71.|Day 1 to Day 71|All participants who received study drug (safety population) and had systolic assessment were included in the analysis. Days 1 and 2 N=36 both arms; Day 15 (Lonza arm N=36; Devens arm N=34; Day 29 (N=33 in both arms); Day 57 (Lonza arm N=31; Devens arm N=33); Day 71 (Lonza arm N=36; Devens arm N=34).||mmHg||Standard Deviation|Mean
691356|NCT01439204|Secondary|Number of Participants With Marked Hematology Abnormalities on Days 2, 15, 29, 57, and 71 - Safety Population|Blood samples obtained: Days 2, 4, 8, 15, 22, 29, 43, 57 and 71. Male(M); Female (F). Reference ranges (low/high) for laboratory parameters for which participants were identified with marked abnormalities during the study: Leukocytes (quantitative White blood cells) (M/F) 4-11*10^3/microliters (µL); Neutrophils (absolute)(M/F) 1.4- 8.2*10^3/µL.|Day 2 to Day 72|All participants who received study drug (safety population) and had a laboratory assessment were included in the analysis. Day 2 N=36 both arms; Day 15 (Lonza arm N=36; Devens arm N=34; Day 29 (Lonza arm N=34; Devens arm N=33); Day 57 (Lonza arm N=31; Devens arm N=33); Day 71 (Lonza arm N=36; Devens arm N=34).||participants|||Number
691357|NCT01439204|Secondary|Number of Participants With Marked Serum Chemistry Abnormalities on Days 2, 15, 29, 57 and 71 - Safety Population|Blood samples obtained: Days 1, 2, 4, 8, 15, 22, 29, 43, 57 and 71. International Units per liter (U/L); milligram per deciliter (mg/dL); Male(M); Female (F). Reference ranges (low/high) for laboratories for which participants were identified with marked abnormalities during the study: Blood Urea Nitrogen (M/F) 10-20mg/dL ; Creatine Kinase (F) 21-21 U/L,(M) 32-294 U/L; Direct Bilirubin (M/F) 0.1-0.4 mg/dL ; Fasting Glucose (M/F) 70-110 mg/dL; Lactate Dehydrogenase (M/F) 110-209 U/L.|Day 2 to Day 71|All participants who received study drug (safety population) and had a laboratory assessment were included in the analysis. Day 2 N=36 both arms; Day 15 (Lonza arm N=36; Devens arm N=34; Day 29 (Lonza arm N=34; Devens arm N=33); Day 57 (Lonza arm N=31; Devens arm N=33); Day 71 (Lonza arm N=36; Devens arm N=34).||participants|||Number
691358|NCT01439204|Secondary|Number of Participants With Positive Abatacept-induced Immunogenicity Response|Immunogenicity determination was based on titers of anti-abatacept and anti- cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4-T) antibodies in serum over time. A participant had a positive abatacept-induced immunogenicity if 1 of the following criteria were met: missing baseline measurement and a positive response after baseline; negative baseline response and positive response after baseline; a baseline response and a positive response after baseline that has a titer value strictly greater than the baseline titer value. A validated, sensitive, electrochemiluminescence assay (ECL) method was used to analyze the antibodies in serum. Samples confirmed positive with ECL and with abatacept serum concentrations of less than equal to 1 µg/mL were further analyzed with a validated, in vitro, cell-based bioassay to analyze the sera containing the abatacept neutralizing activity. Samples obtained on Days 29, 57 and 71 post dose of abatacept on Day 1 (baseline).|Days 29, 57, 71|Immunogenicity Data Set: All participants with at least 1 postdose visit.||participants|||Number
694334|NCT01402102|Secondary|Changes in Total Cholesterol|Total cholesterol was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis||mg/dL||Standard Deviation|Mean
691359|NCT01439204|Primary|Volume of Distribution at Steady-state (Vss) of Single Dose Abatacept - Pharmacokinetic Evaluable Population|Vss was derived from serum concentration versus time data. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: predose (0 hours), 0.25 hours (h), 0.5, 1, 2, 6, 12, 24, 72, 168, 336, 504, 672, 1008, 1344, and 1688 h post dose (Days 1 to 71). The results were summarized. The lower limit of assay quantitation (LLOQ) was 1.00 nanograms per milliliter (ng/mL). Vss was measured in liters per kg body weight (L/kg).|Day 1 to Day 71|Pharmacokinetic (PK) population: all participants who received study drug and had adequate PK profiles.||L/kg||Geometric Coefficient of Variation|Geometric Mean
691360|NCT01439204|Primary|Total Body Clearance (CLT) of Single Dose Abatacept - Pharmacokinetic Evaluable Population|CLT was the volume of abatacept cleared by the system, normalized by baseline body weight. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: predose (0 hours), 0.25 hours (h), 0.5, 1, 2, 6, 12, 24, 72, 168, 336, 504, 672, 1008, 1344, and 1688 h post dose (Days 1 to 71). The results were summarized. The lower limit of assay quantitation (LLOQ) was 1.00 nanograms per milliliter (ng/mL). CLT was measured in milliliters per hours per kilogram of body weight (mL/h/kg).|Day 1 to Day 71|Pharmacokinetic (PK) population: all participants who received study drug and had adequate PK profiles.||mL/h/kg||Geometric Coefficient of Variation|Geometric Mean
691361|NCT01439204|Primary|Terminal Phase Elimination Half-life (T-HALF) of Single Dose Abatacept - Pharmacokinetic Evaluable Population|T-HALF was derived from serum concentration versus time data. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: predose (0 hours), 0.25 hours (h), 0.5, 1, 2, 6, 12, 24, 72, 168, 336, 504, 672, 1008, 1344, and 1688 h post dose (Days 1 to 71). The results were summarized. The lower limit of assay quantitation (LLOQ) was 1.00 nanograms per milliliter (ng/mL). T-HALF was measured in hours (h).|Day 1 to Day 71|Pharmacokinetic (PK) population: all participants who received study drug and had adequate PK profiles.||h||Standard Deviation|Mean
691362|NCT01439204|Primary|Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity [AUC(0 - INF)] of Single Dose Abatacept - Pharmacokinetic Evaluable Population|AUC (0 - INF) was derived from serum concentration versus time data. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: predose (0 hours), 0.25 hours (h), 0.5, 1, 2, 6, 12, 24, 72, 168, 336, 504, 672, 1008, 1344, and 1688 h post dose (Days 1 to 71). The results were summarized. The lower limit of assay quantitation (LLOQ) was 1.00 nanograms per milliliter (ng/mL). AUC (0 - INF) was measured in µg*h/mL.|Day 1 to Day 71|Pharmacokinetic (PK) population: all participants who received study drug and had adequate PK profiles.||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
691363|NCT01439204|Primary|Area Under the Concentration-time Curve From Zero to the Last Time of the Last Quantifiable Concentration [AUC(0-T)] of Single Dose Abatacept - Pharmacokinetic Evaluable Population|AUC (0 - T) was derived from serum concentration versus time data. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: predose (0 hours), 0.25 hours (h), 0.5, 1, 2, 6, 12, 24, 72, 168, 336, 504, 672, 1008, 1344, and 1688 h post dose (Days 1 to 71). The results were summarized. The lower limit of assay quantitation (LLOQ) was 1.00 nanograms per milliliter (ng/mL). AUC (0 - T) was measured in micro grams*hour per milliliter (µg*h/mL).|Day 1 to Day 71|Pharmacokinetic (PK) population: all participants who received study drug and had adequate PK profiles.||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
691364|NCT01439204|Primary|Area Under the Concentration-time Curve (AUC) From Time Zero to 28 Days [AUC(0-28 Days)] of Single Dose Abatacept - Pharmacokinetic Evaluable Population|AUC (0 - 28) was derived from serum concentration versus time data. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: predose (0 hours), 0.25 hours (h), 0.5, 1, 2, 6, 12, 24, 72, 168, 336, 504, 672, 1008, 1344, and 1688 h post dose (Days 1 to 71). The results were summarized. The lower limit of assay quantitation (LLOQ) was 1.00 nanograms per milliliter (ng/mL). AUC (0 - 28) was measured in micro grams*hours per milliliter (µg*h/mL).|Day 1 to Day 71|Pharmacokinetic (PK) population: all participants who received study drug and had adequate PK profiles.||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
691365|NCT01439204|Primary|Time to Reach Maximum Concentration (Tmax) of Single Dose Abatacept - Pharmacokinetic Evaluable Population|Tmax was derived from serum concentration versus time data. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: predose (0 hours), 0.25 hours (h), 0.5, 1, 2, 6, 12, 24, 72, 168, 336, 504, 672, 1008, 1344, and 1688 h post dose (Days 1 to 71). The results were summarized. The lower limit of assay quantitation (LLOQ) was 1.00 nanograms per milliliter (ng/mL). Tmax was measured in hours (h).|Day 1 to Day 71|Pharmacokinetic (PK) population: all participants who received study drug and had adequate PK profiles.||h||Full Range|Median
691366|NCT01439204|Primary|Maximum Observed Concentration (Cmax) of Single Dose Abatacept - Pharmacokinetic Evaluable Population|Cmax was derived from serum concentration versus time data. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: predose (0 hours), 0.25 hours (h), 0.5, 1, 2, 6, 12, 24, 72, 168, 336, 504, 672, 1008, 1344, and 1688 h post dose (Days 1 to 71). The results were summarized. The lower limit of assay quantitation (LLOQ) was 1.00 nanograms per milliliter (ng/mL). Cmax was measured in micro grams per milliliter (µg/mL).|Days 1 to 71|Pharmacokinetic (PK) population: all participants who received study drug and had adequate PK profiles. All completers had evaluable PK.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
691453|NCT01438307|Primary|Objective Response Rate|The objective response is defined as the percentage of patients that achieve a complete and/or partial response according to The Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1).|Baseline up to 28 months|||participants|||Number
692603|NCT01426438|Secondary|Change in HDL Particles|Change in total HDL particles from week 0 to week 24|0 and 24 weeks|This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.||nmol/L||Inter-Quartile Range|Median
691372|NCT01439126|Secondary|Long-term Safety of KAPVAY in Children and Adolescents With ADHD Based on the Assessment of Changes in the Columbia Suicide Severity Rating Scale (C-SSRS)|"The outcome reported is the number of subjects that responded Yes to the question “Do you have a wish to be dead” at Visit 20.
C-SSRS is a clinician-rated instrument designed to provide consistent and systematic assessment of both suicidal ideation and behavior within a study, as well as across studies. The scale is a feasible, low burden series of questions that appropriately assess and track all suicidal events, including ideation. Suicidal ideation is assessed according to yes/no responses to 5 questions of increasing severity (from a wish to die to an active thought of killing oneself with plan and intent) as follows:
Wish to be Dead
Non-Specific Active Suicidal Thoughts
Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act
Active Suicidal Ideation with Some Intent to Act, without Specific Plan
Active Suicidal Ideation with Specific Plan and Intent"|Visit 20 (Week 40)|Double-Blind Full Analysis Set||participants|||Number
691373|NCT01439126|Secondary|Long-term Safety of KAPVAY in Children and Adolescents With ADHD Based on the Assessment of Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Study Drug Discontinuation, Clinically Significant Changes or Abnormalities in Vital Signs||From study start to study end (40 weeks)|Double-Blind Full Analysis Set||Participants|||Number
691374|NCT01439126|Secondary|Long-term Efficacy of KAPVAY in Children and Adolescents With ADHD as Measured by the Change From Randomization to the End of the Randomized-withdrawal Period on the Epworth Sleepiness Scale for Children (ESS-C)|"Change in the ESS-C scale from randomization to end of randomized-withdrawal period. The ESS-C is a simple eight-tem Likert scale designed to assess daytime sleepiness in children aged 2-18 years. The scale takes less than two minutes to be completed by patient or by parent rating. Sleepiness is a common symptom in both medicated and unmedicated children with ADHD given the predominance of impaired sleep quality. The total score achieved when the chance of dozing in each situation is added up serves as the outcome measure.
The ESS-C comprises 8 items describing various daytime activities. Item scores ranging from 0 (“would never doze or sleep”) to 3 (“high chance of dozing or sleeping”). A total score is derived as the sum of the items, with higher total scores indicative of a greater level of sleepiness (worse outcome). Total scores range from 0 to 24."|From randomization to end of the randomized-withdrawal period (26 weeks)|Double-Blind Full Analysis Set||units on a scale||Standard Deviation|Mean
691375|NCT01439126|Secondary|Long-term Efficacy of KAPVAY in Children and Adolescents With ADHD as Measured by the Change From Randomization to the End of the Randomized-withdrawal Period on the Weiss Functional Impairment Rating Scale-Parent (WFIRS-P)|"The WFIRS-P is designed to assess the impact of child’s behavior or emotional problems on 7 domains related to function: Family (10 items), School Learning (4 items), School Behavior (6 items), Life Skills (10 items), Child’s Self-concept (3 items), Social Activities (7 items), and Risky Activities (10 items). Each item was scored on a scale ranging from 0 (“never or not at all”) to 3 (“very often or very much”). Each scale score was calculated as the average for that scale. The total score is the average of all non-missing items. Higher scores are associated with greater impact of disease on functioning."|From randomization to end of the randomized-withdrawal period (26 weeks)|Double-Blind Full Analysis Set||units on a scale||Standard Deviation|Mean
691376|NCT01439126|Secondary|Long-term Efficacy of KAPVAY in Children and Adolescents With ADHD as Measured by the Change From Randomization to the End of the Randomized-withdrawal Period on the Clinical Global Impressions-Severity of Illness Scale (CGI-S)|"The CGI-S is a clinician rated instrument designed to assess the subject’s current illness state. The CGI-Severity (CGI-S) asks the clinician one question: “Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?” which is rated on the following seven-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients.
This rating is based upon observed and reported symptoms, behavior, and function in the past seven days."|From randomization to end of the randomized-withdrawal period (26 weeks)|Double-Blind Full Analysis Set||scores on a scale||Standard Deviation|Mean
733992|NCT00424190|Secondary|Microbiological Success Rate at the TOC Visit||8-15 days after last dose of study drug||||||
691377|NCT01439126|Secondary|Long-term Efficacy of KAPVAY in Children and Adolescents With ADHD as Measured by the Change From Randomization to the End of the Randomized-withdrawal Period on the ADHD-Rating Scale-4th Edition (ADHD-RS-IV)|The ADHD-RS-IV (clinician version), has been widely used as a measure of efficacy in clinical trials of treatments in children and adolescents with ADHD. It is derived from the 18 inattentive and hyperactive/impulsive diagnostic criteria for ADHD from the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR). The clinician version of the ADHD-RS-IV has a large base of normative data and has demonstrated reliability and discriminant validity in children and adolescents. The ADHD-RS-IV of 2 subscales: inattention - 9 items and hyperactivity-impulsivity - 9 items. Each gives a score ranging from 0 (none, never or rarely) to 3 (severe, very often), for a total score ranging from 0 to 54 (higher score worse and a lower score more favourable). Two subscales are summed.|From randomization to end of the randomized-withdrawal period (26 weeks)|Double-Blind Full Analysis Set||scores on a scale||Standard Deviation|Mean
691378|NCT01439126|Secondary|To Evaluate the Long-term Efficacy of KAPVAY in Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD) as Measured by the Time to Treatment Failure From the Start of Randomized-withdrawal Period|Time to treatment failure was calculated as follows: Treatment failure (not premature termination) = visit date where the failure criteria was met – visit 9 date + 1; Treatment failure (premature termination) = termination date – visit 9 date + 1|Time From randomization to treatment failure (up to 26 weeks)|Double-Blind Full Analysis Set||days||95% Confidence Interval|Median
691379|NCT01439126|Primary|Long-term Maintenance of Efficacy of KAPVAY in Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD) as Measured by the Percentage of Treatment Failures in the KAPVAY vs. Placebo Groups|"Treatment failure a ≥30 percentage increase (worsening)(ADHD-RS-IV, clinician version) total score and a ≥2 point increase (worsening) in Clinical Global Impressions-Severity of Illness Scale (CGI-S) at any two consecutive visits during the randomized-withdrawal period.
The ADHD-RS-IV of 2 subscales: inattention - 9 items and hyperactivity-impulsivity - 9 items. Each gives a score ranging from 0 (none, never or rarely) to 3 (severe, very often), for a total score ranging from 0 to 54 (higher score worse).
The CGI-S is a 7-point scale,1 (Normal, not at all ill) to 7 (extremely ill patients).The CGI-Severity (CGI-S) asks the clinician one question: “Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?” which is rated on the following seven-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients."|From randomization to end of the randomized-withdrawal period (26 weeks)|Double-Blind Full Analysis Set. This set included all randomized subjects who took at least 1 dose of study medication during the double blind (randomized-withdrawal) phase||% of Participants|||Number
691380|NCT01439074|Secondary|% of Study Burn Healed After One Week||1 week|||percentage of study burn healed||Standard Deviation|Mean
691381|NCT01439074|Secondary|Number of Dressing Changes|Including first assembly|4 weeks|||applications||Standard Deviation|Mean
691382|NCT01439074|Secondary|Percent of Burn Epithelised/Healed|Healing will be defined as 95% or more epithelialisation|4 weeks|||percentage of study burn healed||Standard Deviation|Mean
691383|NCT01439074|Primary|Time to Healing|Number of days|4 weeks|||days||Standard Deviation|Mean
691384|NCT01438996|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)||During the 28-day period after vaccination|||participants|||Number
691385|NCT01438996|Secondary|Number of Subjects Reporting AE|AE during 28 days after vaccination(including solicited reactions during 7 days after vaccination)|During the 28-day period after vaccination|||participants|||Number
691386|NCT01438996|Secondary|Number of Subjects Reporting Any (Local, Systemic and Other) Post Vaccination Reaction|Solicited reactions collected during the 7-day period after vaccination are pain, erythema, induration, chills, malaise, myalgia, headache, arthralgia, fatigue and fever.|During the 7-day period after vaccination|||participants|||Number
691387|NCT01438996|Primary|Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titers||At 28 days after vaccination as compared to baseline|||percentage of subjects||95% Confidence Interval|Number
691388|NCT01438996|Primary|Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titers||At 7 days after vaccination as compared to baseline|||percentage of subjects||95% Confidence Interval|Number
691389|NCT01438996|Primary|Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titers||At 3 days after vaccination as compared to baseline|||percentage of subjects||95% Confidence Interval|Number
691390|NCT01438996|Primary|Anti-Vi ELISA GMC|To evaluate the immunogenicity and the kinetics of the immune response induced by one dose of NVGH Vi-CRM197 at study day 28 after vaccination as as measured by ELISA|At 28 days after vaccination|||ELISA Units/mL||95% Confidence Interval|Geometric Mean
691391|NCT01438996|Primary|Anti-Vi ELISA GMC|To evaluate the immunogenicity and the kinetics of the immune response induced by one dose of NVGH Vi-CRM197 at study day 7 after vaccination as as measured by ELISA|At 7 days after vaccination|||ELISA Units/mL||95% Confidence Interval|Geometric Mean
691392|NCT01438996|Primary|Anti-Vi ELISA Geometric Mean Concentration (GMC)|To evaluate the immunogenicity and the kinetics of the immune response induced by one dose of NVGH Vi-CRM197 at study day 3 after vaccination as as measured by enzyme-linked immunosorbent assay (ELISA)|At 3 days after vaccination|||ELISA Units/mL||95% Confidence Interval|Geometric Mean
691393|NCT01438814|Secondary|Change From Baseline in HbA1c Over Time|Means are adjusted by treatment and continuous baseline HbA1c|Baseline, 2 weeks and 8 weeks|Patients from FAS1000 (LOCF)||percent||Standard Error|Mean
691394|NCT01438814|Secondary|Composite Endpoint of Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.8% After 14 Weeks of Treatment) and no Occurrence of Moderate and Severe Metformin Pre-specified GI Side Effects Assessed by Investigators During 14 Weeks|The proportion of patients who achieved all the targets in a composite endpoint (HbA1c lowered by at least 0.8% after 14 weeks of treatment; no occurrence of pre-specified moderate or severe GI side effects of metformin, as assessed by the investigators during 14 weeks of treatment).|14 weeks|Patients from FAS1000 (NCF)||participants|||Number
691395|NCT01438814|Secondary|Change From Baseline in Body Weight by Visit at Week 14|Means are adjusted by treatment, continuous baseline HbA1c and continuous baseline weight|Baseline and 14 weeks|FAS1000 having values for weight at baseline and week 14.||kg||Standard Error|Mean
738602|NCT00450749|Secondary|Modulation of Expression of Androgen-related Genes as Measured by Microarray in Prostatic Surgical Tissue||At 4-7 weeks||||||
691396|NCT01438814|Secondary|Composite Endpoint of Occurence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 14 Weeks of Treatment) and no Occurence of Moderate and Severe Metformin Pre-specified GI Side Effects Assessed by the Investigators During 14 Weeks|The proportion of patients who achieved all the targets in a composite endpoint (HbA1c lowered by at least 0.5% after 14 weeks of treatment; no occurrence of pre-specified moderate or severe GI side effects of metformin, as assessed by the investigators during 14 weeks of treatment).|14 weeks|Patients from FAS1000 (NCF)||participants|||Number
691397|NCT01438814|Secondary|Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.8% After 14 Weeks of Treatment)|The proportion of patients who achieved a relative efficacy response (HbA1c lowering by at least 0.8% after 14 weeks of treatment).|14 weeks|Patients from the FAS1000 (NCF)||participants|||Number
691398|NCT01438814|Secondary|Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 14 Weeks of Treatment)|The proportion of patients who achieved a relative efficacy response (HbA1c lowering by at least 0.5% after 14 weeks of treatment).|14 weeks|Patients from FAS1000 (NCF)||participants|||Number
691399|NCT01438814|Secondary|Composite Endpoint of Occurrence of Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <6.5% After 14 Weeks of Treatment, and no Occurrence of Moderate or Severe Metformin Pre-specified GI Side Effects Assessed by Investigators|The proportion of patients who achieved all the targets in a composite endpoint (HbA1c below 6.5% after 14 weeks of treatment; no occurrence of pre-specified moderate or severe GI side effects of metformin, as assessed by the investigators during 14 weeks of treatment).|14 weeks|Patients from FAS1000 (NCF) having a baseline HbA1c>=6.5%.||participants|||Number
691400|NCT01438814|Secondary|Metformin Pre-specified GI Symptom Intensity Score Assessed by Patients During 14 Weeks of Treatment|The intensity of the GI side effects was also assessed by the patients using VAS scaled from 0 to 10; higher scores indicate more severe events. Means are adjusted by treatment and continuous baseline HbA1c.|14 weeks|Patients from the FAS1000 using original results (OR) and having GI adverse events which were assessed for severity by the patient.||units on a scale||Standard Error|Mean
691401|NCT01438814|Secondary|Metformin Pre-specified GI Symptom Intensity Score Assessed by Investigators During 14 Weeks of Treatment|Patients could experience multiple events, therefore, multiple answers were possible for each patient.|14 weeks|Patients from FAS1000 and having GI adverse events which were assessed for severity by the investigator.||events|Participants||Number
691402|NCT01438814|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) After 14 Weeks of Treatment|Means are adjusted by treatment, continuous baseline HbA1c and continuous baseline fasting plasma glucose.|Baseline and 14 weeks|Patients from FAS1000 with LOCF||mg/dL||Standard Error|Mean
691403|NCT01438814|Secondary|Occurence of Metformin Pre-specified Moderate to Severe GI Side Effects Assessed by Investigators During 14 Weeks of Treatment|Proportion of patients who experienced at least one metformin pre-specified moderate or severe GI side effect during 14 weeks|14 weeks|Patients from FAS1000||participants|||Number
691404|NCT01438814|Secondary|Composite Endpoint of Occurrence of Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <7.0% After 14 Weeks of Treatment, on no Occurrence of Moderate or Severe Gastrointestinal (GI) Side Effects During 14 Weeks of Treatment|The proportion of patients who achieved all the targets in a composite endpoint (HbA1c below 7.0% after 14 weeks of treatment; no occurrence of pre-specified moderate or severe gastrointestinal (GI) side effects of metformin, as assessed by the investigators during 14 weeks of treatment)|14 weeks|Patients from FAS1000 with non-completer considered as failure (NCF) having a baseline HbA1c>=7.0%.||participants|||Number
691405|NCT01438814|Primary|Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) After 14 Weeks Treatment|Adjusted mean change in HbA1c from baseline at Week 14 was analysed using an ANCOVA model. The Model included treatment and continuous baseline HbA1c.|Baseline and 14 weeks|FAS1000mg with last observation carried forward (LOCF): all patients randomised and treated who had a baseline at least 1 on-treatment HbA1c value and who tolerated a daily metformin dose of at least 1000 mg at the end of the titration phase.||percent||Standard Error|Mean
691406|NCT01438710|Primary|Evaluation of Hand Tremor and Stable Kidney Transplant Patients When Switched From Prograf to LCP-Tacro.|"The primary efficacy endpoint is the mean change from baseline (ie Day 7) in the Fahn-Tolosa-Marin Clinical Rating Scale (FTM) for overall tremor score 7 days after (ie, Day 14) LCP-Tacro conversion.
The overall FTM score was 0 to 100 where higher scores denoted worst/more severe tremor.
Below the mean total score and standard deviation for each treatment is given in addition to the mean change."|14 days|"Of the 40 patients who completed the study period, 38 patients were evaluable for efficacy evaluation and included in the modified intention to treat (mITT) population.
The outcome measure is given as total score below."||units on a scale||Standard Deviation|Mean
691407|NCT01438541|Secondary|Evaluate the Dressing Shape|Investigator and Nurses evaluated the shape of the dressing rated on a scale from Very Poor, Poor,Good, Very Good, Excellent|14 days|||participants|||Number
691408|NCT01438541|Secondary|Overall Experience of Use of the Dressing|Investigator and Nurses evaluate the overall Experience of using of the dressing rated on a scale from Very Poor, Poor,Good, Very Good, Excellent, Not measured|14 days|||participants|||Number
691409|NCT01438541|Primary|Erythema ( No/Yes)|Total improvement of erythema|14 days|Vulnerable subjects with high risk of skin breakdown.||participants|||Number
691410|NCT01438489|Secondary|Accumulation Ratio of Trough Concentration (Ctrough,AR) of Anifrolumab at Day 169 and 365|Accumulation ratio for trough concentration (Ctrough,AR) of anifrolumab after multiple administration at Day 169 and 365 was calculated.|Pre-infusion and 15 minutes post-infusion on Day 169 and 365|"The Pharmacokinetic population included all treated participants with at least 1 Pharmacokinetic assessment. Here, N signifies evaluable participants for this outcome measure and n signifies evaluable participants for the specified category of the arms respectively."||Ratio||Full Range|Median
691411|NCT01438489|Secondary|Trough Concentration (Ctrough) of Anifrolumab at Day 29, 169 and 365|Trough concentration (Ctrough) of anifrolumab at Day 29, 169 and 365 were calculated.|Pre-infusion and 15 minutes post-infusion on Day 29, 169 and 365|"The Pharmacokinetic population included all treated participants with at least 1 Pharmacokinetic assessment. Here, N signifies evaluable participants for this outcome measure and n signifies evaluable participants for the specified category of the arms respectively."||microgram per milliliter||Standard Deviation|Mean
694335|NCT01402102|Secondary|Changes in Triglycerides|Triglyceride was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|PP analysis||mg/dl||Standard Deviation|Mean
691412|NCT01438489|Secondary|Accumulation Ratio of Maximum Observed Plasma Concentration (Cmax,AR) of Anifrolumab|Accumulation ratio for maximum plasma concentration (Cmax,AR) of anifrolumab after multiple administration at Day 169 and 337 was calculated.|Pre-infusion and 15 minutes post-infusion on Day 169 and 337|"The Pharmacokinetic population included all treated participants with at least 1 Pharmacokinetic assessment. Here, N signifies evaluable participants for this outcome measure and n signifies evaluable participants for the specified category of the arms respectively."||Ratio||Full Range|Median
691413|NCT01438489|Secondary|Maximum Observed Plasma Concentration (Cmax) of Anifrolumab at Day 1, 169 and 337|Maximum plasma concentration (Cmax) was defined as the peak plasma level of anifrolumab, derived from plasma concentration ­time data.|Pre-infusion and 15 minutes post-infusion on Day 1, 169 and 337|"The Pharmacokinetic population included all treated participants with at least 1 Pharmacokinetic assessment. Here, N signifies evaluable participants for this outcome measure and n signifies evaluable participants for the specified category of the arms respectively."||micrograms/milliliter (mcg/mL)||Standard Deviation|Mean
691414|NCT01438489|Secondary|Neutralization Ratio of 21-Gene Type I Interferon (IFN) Signature for Participants With Positive Baseline Pharmacodynamic (PD) Gene Signature|The PD positive and negative gene signature was determined by comparing the expression of type I IFN-inducible genes in a 21-gene panel in study participants relative to pooled normal blood collected from healthy participants.|Days 29, 85, 141, 169, 253, 337 (treatment phase), on Days 365, 396, and 422 (follow up period)|"The mITT population included all randomized participants who received any investigational product and had a baseline primary efficacy measurement. Here, N signifies evaluable participants for this outcome measure and n signifies evaluable participants for the specified category of the arms respectively."||Ratio||Standard Deviation|Mean
691415|NCT01438489|Secondary|Percentage of SLE Participants With Positive Anti-drug Antibody (ADA)|Anti-drug antibody responses to anifrolumab in serum were evaluated.|Days 1, 85, 141, 169, 253, 337 (Treatment Phase), 365, 396, and 422 (Follow-up Period)|"The safety population included participants who received any investigational product. Here, N and “n” signifies evaluable participants for this outcome measure and for specified category of the arms respectively. One participant from Placebo group received Anifrolumab 1000 mg once and hence, included it in Anifrolumab 1000 mg group."||Percentage of Participants|||Number
691416|NCT01438489|Secondary|Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)|Any medically significant changes from the screening ECG was recorded as TEAEs. An abnormal ECG findings such as QT prolonged were reported as treatment emergent adverse events.|Day 1 (Baseline) to Day 422 (End of Study)|"The safety population included participants who received any investigational product. Here, N signifies evaluable participants for this outcome measure. One participant from Placebo group received Anifrolumab 1000 mg once and hence, included it in the Anifrolumab 1000 mg group."||Participants|||Number
691417|NCT01438489|Secondary|Number of Participants With Vital Signs Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)|Vital sign parameters are temperature, blood pressure, respiratory rate, heart rate and weight. Vital signs abnormalities were reported as TEAEs.|Day 1 (Baseline) to Day 422 (End of Study)|"The safety population included participants who received any investigational product. Here, N signifies evaluable participants for this outcome measure. One participant from Placebo group received Anifrolumab 1000 mg once and hence, included it in the Anifrolumab 1000 mg group."||Participants|||Number
691418|NCT01438489|Secondary|Number of Participants With Clinically Significant Laboratory Abnormalities in Investigations Reported as Treatment-Emergent Adverse Events|Any medically significant change in laboratory evaluations were recorded as Treatment emergent adverse events.|Day 1 (Baseline) to Day 422 (End of Study)|"The safety population included participants who received any investigational product. Here, N signifies evaluable participants for this outcome measure. One participant from Placebo group received Anifrolumab 1000 mg once and hence, included it in the Anifrolumab 1000 mg group."||Participants|||Number
691419|NCT01438489|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESIs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a study participant administered a pharmaceutical product and which does not necessarily have a causal relationship with treatment. A serious AE (SAE) was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly (in offspring of participant). AEs may be treatment emergent (TE) [that is, occurring after initial receipt of investigational product] or non-TE. An AESI is one of scientific and medical concern specific to understanding biologics and requires close monitoring and rapid communication by investigator to sponsor.|Day 1 (Baseline) to Day 422 (End of Study)|"The safety population included participants who received any investigational product. Here, N signifies evaluable participants for this outcome measure. One participant from Placebo group received Anifrolumab 1000 mg once and hence, included it in the Anifrolumab 1000 mg group."||Participants|||Number
691420|NCT01438489|Secondary|Percentage of Participants on Oral Corticosteroids (OCS) >=10 mg/Day of Prednisone or Equivalent at Baseline Who Were Able to Taper to Less Than or Equal to (<=) 7.5 mg/Day at Day 365|Participants on OCS >=10 mg/day of prednisone or equivalent at baseline who were able to taper to <= 7.5 mg/day at Day 365 were evaluated.|Day 365|"The mITT population included all randomized participants who received any investigational product and had a baseline primary efficacy measurement. Here, N signifies evaluable participants for this outcome measure."||Percentage of Participants|||Number
691421|NCT01438489|Secondary|Percentage of Participants Achieving an Systemic Lupus Erythematosus (SLE) Responder Index [SRI (4)] Response With Oral Corticosteroids (OCS) Tapering at Day 365|An SRI (4) Responder was defined as a participant who had 1) a reduction in baseline SLEDAI-2K disease activity score of >= 4 points; 2) no worsening of disease from baseline as measured by the MDGA (worsening was defined as an increase of >= 0.3 from baseline on a 0 to 3.0 visual analog scale); and 3) no new British Isles Lupus Assessment Group 2004 (BILAG-2004) Index A organ system score and no more than one new or worsening BILAG-2004 Index B organ system score. OCS tapering requires a sustained reduction of OCS from Day 281 through Day 365 (less than 10 mg/day and less or equal to the dose received on Day 1). SRI was analyzed by a logistic regression model.|Day 365|"The mITT population included all randomized participants who received any investigational product and had a baseline primary efficacy measurement. Here, N signifies evaluable participants for this outcome measure."||Percentage of Participants|||Number
691422|NCT01438489|Primary|Percentage of Type I Interferon (IFN) Test High Participants Achieving an Systemic Lupus Erythematosus Responder Index (SRI) (4) Response With Oral Corticosteroids (OCS) Tapering at Day 169|Type I IFN signature in whole blood assessed by using a 4-gene diagnostic test. The blood samples collected were to be used to prospectively identify participants as IFN test-high or test-low. The results of this test were used to stratify participants. An SRI (4) Responder was defined as a participant who had 1) a reduction in baseline SLEDAI-2K disease activity score of >= 4 points; 2) no worsening of disease from baseline as measured by the Physician Global Assessment (MDGA) (worsening was defined as an increase of >= 0.3 from baseline on a 0 to 3.0 visual analog scale); and 3) no new British Isles Lupus Assessment Group 2004 (BILAG-2004) Index A organ system score and no more than one new or worsening BILAG-2004 Index B organ system score. OCS tapering requires a sustained reduction of OCS from Day 85 through Day 169 [less than 10 mg/day and less or equal to the dose received on Day 1]. SRI was analyzed by a logistic regression model.|Day 169|"The mITT population included all randomized participants who received any investigational product and had a baseline primary efficacy measurement. Here, N signifies evaluable participants for this outcome measure."||Percentage of Participants|||Number
691423|NCT01438489|Primary|Percentage of Participants Achieving an Systemic Lupus Erythematosus (SLE) Responder Index [SRI (4)] Response With Oral Corticosteroids (OCS) Tapering at Day 169|An SRI (4) responder defined as a participant who had 1) a reduction in baseline Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score of greater than or equal to (>=) 4 points; 2) no worsening of disease from baseline as measured by the Physician Global Assessment (MDGA) (worsening was defined as an increase of >= 0.3 from baseline on a 0 to 3.0 visual analog scale); and 3) no new British Isles Lupus Assessment Group 2004 (BILAG-2004) Index ‘A’ organ system score and no more than one new or worsening BILAG-2004 Index ‘B’ organ system score. OCS tapering requires a sustained reduction of OCS from Day 85 through Day 169 [less than 10 milligram per day (mg/day) and less or equal to the dose received on Day 1]. SRI was analyzed by a logistic regression model.|Day 169|"The modified Intent-To-Treat (mITT) population included all randomized participants who received any investigational product and had a baseline primary efficacy measurement. Here, N signifies evaluable participants for this outcome measure."||Percentage of Participants|||Number
691424|NCT01438424|Secondary|Off-treatment Follow-up: Mean Change in HBV DNA (Amendment 11 Cohort)|The Amendment 11 Cohort consisted of participants who were HBeAg negative and who had compensated liver disease, a minimum of 192 weeks (4 years) of treatment with entecavir, HBV DNA <300 copies/mL by PCR assay for ≥48 weeks before end of dosing and on the last observed result ≤24 weeks prior to end of dosing, and serum ALT levels ≤1.0*ULN at the end of study drug dosing.|End of dosing to Weeks 48 and 96 off-treatment follow-up|Participants who were HBeAg negative and who had liver disease, a minimum of 192 weeks of entecavir treatment, HBV DNA <300 copies/mL by PCR assay for ≥48 weeks before end of dosing and on the last observed result ≤24 weeks before end of dosing, and had serum ALT levels ≤1.0*ULN at the end of study drug dosing. (n=number of evaluable participants)||Log10 copies/mL||Standard Error|Mean
691425|NCT01438424|Secondary|Off-treatment Follow-up: Percentage of Participants With Sustained HBV DNA <1,000, <300, and <10,000 Copies/mL by PCR Assay and With ALT ≤1*ULN (Amendment 11 Cohort)|The Amendment 11 Cohort consisted of participants who were HBeAg negative and who had compensated liver disease, a minimum of 192 weeks (4 years) of treatment with entecavir, HBV DNA <300 copies/mL by PCR Assay for ≥48 weeks before end of dosing and on the last observed result ≤24 weeks prior to end of dosing, and serum ALT levels ≤1.0*ULN at the end of study drug dosing. ULN=upper limit of normal.|End of dosing to Weeks 48 and 96 off-treatment follow-up|Participants who were HBeAg negative and who had liver disease, a minimum of 192 weeks of entecavir treatment, HBV DNA <300 copies/mL by PCR assay for ≥48 weeks before end of dosing and on the last observed result ≤24 weeks before end of dosing, and serum ALT levels ≤1.0*ULN at the end of study drug dosing. (n=number of evaluable participants)||Percentage of participants|||Number
691426|NCT01438424|Primary|Off-treatment Follow-up: Percentage of Participants With Sustained Hepatitis B Virus (HBV) DNA <10,000 Copies by Polymerase Chain Reaction (PCR) Assay (Amendment 11 Cohort)|The Amendment 11 Cohort consisted of participants who were hepatitis B e antigen (HBeAg) negative and who had compensated liver disease, a minimum of 192 weeks (4 years) of treatment with entecavir, HBV DNA <300 copies/mL by PCR assay for ≥48 weeks before end of dosing and on the last observed result ≤24 weeks prior to end of dosing, and serum ALT levels ≤1.0*ULN at the end of study drug dosing.ALT=alanine aminotransferase; ULN=upper limit of normal.|End of dosing to Week 48 off-treatment follow-up|Participants who were HBeAg negative and who had compensated liver disease, a minimum of 192 weeks (4 years) of treatment with entecavir, HBV DNA <300 copies/mL by PCR assay for ≥48 weeks before end of dosing and on the last observed result ≤24 weeks prior to end of dosing, and serum ALT levels ≤1.0*ULN at the end of study drug dosing.||Percentage of participants|||Number
691427|NCT01438424|Secondary|Week 144: Percentage of Participants Who Achieved HBV DNA <300 Copies/mL by PCR Assay and ALT ≤1.0*ULN (Lamivudine Retreatment Switch Cohort)|The Lamivudine Retreatment Switch Cohort consisted of participants who were nucleoside-naive HBeAg negative and enrolled from BMS study AI463-027 (NCT00035789) with >60 days between end of dosing in AI463-027 and the switch to entecavir in the current study. This cohort permitted assessment of entecavir, 1.0 mg, provided as switch therapy in the current study.|Baseline to Week 144|Participants enrolled from study AI463-027 who were nucleoside-naive HBeAg-negative and had >60 days off treatment between the last dose in AI463-027 and the first dose in the current study. (n=number of evaluable participants)||Percentage of participants|||Number
691428|NCT01438424|Secondary|Week 96: Percentage of Participants Who Achieved HBV DNA <300 Copies/mL by PCR Assay and ALT ≤1.0*ULN (Lamivudine Retreatment Switch Cohort)|The Lamivudine Retreatment Switch Cohort consisted of participants who were nucleoside-naive HBeAg negative and enrolled from BMS study AI463-027 (NCT00035789) with >60 days between end of dosing in AI463-027 and the switch to entecavir in the current study. This cohort permitted assessment of entecavir, 1.0 mg, provided as switch therapy in the current study.|Baseline to Week 96|Participants enrolled from AI463-027 who were nucleoside-naive HBeAg-negative, received lamivudine, and had >60 days between end of dosing in AI463-027 and the switch to entecavir in the current study. (n=number of evaluable participants)||Percentage of participants|||Number
691477|NCT01438229|Other Pre-specified|24hr Ambulatory Diastolic BP Change|Average of readings taken every half hour during the course of a 24hr period wearing the ambulatory blood pressure monitor. Includes only subjects who completed the test at both baseline and follow up. If a subject refused to wear the monitor they were excluded.|Baseline to 6 months|||mmHg||Standard Deviation|Mean
691429|NCT01438424|Primary|Week 192: Number of Participants With Death As Outcome, Any AE, Grade 3-4 AEs, SAEs, Discontinuations Due to AEs, and Abnormalities in Selected Laboratory Test Results|An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. CTC Grade 1=mild; Grade 2=moderate; Grade 3=severe; Grade 4=life-threatening or disabling. ALT=alanine aminotransferase; ULN=upper limit of normal.|Continuously from Day 1 through Week 192|Participants who enrolled from Phase 3 studies of nucleoside-naive HBeAg-positive (AI463-022) and HBeAg-negative (AI463-027) participants and received at least 1 dose of study drug in the current study up to Week 192. (n=number of evaluable participants)||Participants|||Number
691430|NCT01438424|Secondary|Week 144: Percentage of Participants Who Achieved HBV DNA <300 Copies/mL by PCR Assay and ALT ≤1.0*ULN (Lamivudine Continuous Switch Cohort)|The Lamivudine Continuous Switch Cohort consisted of participants who were nucleoside-naive, HBeAg-positive and received lamivudine in BMS study AI463-022 (NCT00035633) and enrolled in the current study with ≤35 days off treatment between end of dosing in AI463-022 and the switch to entecavir in the current study. This cohort permitted assessment of entecavir, 1.0 mg, provided as switch therapy in the current study.|Baseline to Week 144|Participants enrolled from AI463-022 who received lamivudine, were nucleoside-naive HBeAg-positive, and had ≤35 days off treatment between end of dosing in AI463-022 and the switch to entecavir in the current study. (n=number of evaluable participants)||Percentage of participants|||Number
691431|NCT01438424|Secondary|Week 96: Percentage of Participants Who Achieved HBV DNA <300 Copies/mL by PCR Assay, Loss of HBeAg, HBeAg Seroconversion, and ALT ≤1.0*ULN (Lamivudine Continuous Switch Cohort)|The Lamivudine Continuous Switch Cohort consisted of participants who were nucleoside-naive, HBeAg-positive and received lamivudine in BMS study AI463-022 (NCT00035633) and enrolled in the current study with ≤35 days off treatment between end of dosing in AI463-022 and the switch to entecavir in the current study. This cohort permitted assessment of entecavir, 1.0 mg, provided as switch therapy in the current study.|Baseline to Week 96|Participants enrolled from AI463-022 who received lamivudine, were nucleoside-naive HBeAg-positive, and had ≤35 days off treatment between end of dosing in AI463-022 and the switch to entecavir in the current study. (n=number of evaluable participants)||Percentage of participants|||Number
691432|NCT01438424|Secondary|Percentage of Participants Who Achieved HBV DNA <300 and <10^4 Copies/mL by PCR Assay and ALT ≤1.0*Upper Limit of Normal (ULN) (Entecavir Retreatment Cohort)|The Entecavir Retreatment Cohort consisted of participants who were nucleoside-naive, HBeAg-negative and enrolled from BMS study AI463-027 with >60 days off treatment between the last dose in AI463-027 and the first dose in the current study. This cohort permitted assessment of entecavir, 1.0 mg, provided as retreatment in the current study.|Baseline to Weeks 48, 96, and 144|Participants enrolled from study AI463-027 who were nucleoside-naive, HBeAg-negative and had >60 days off treatment between the last dose in AI463-027 and the first dose in the current study. (n=number of evaluable participants)||Percentage of participants|||Number
691433|NCT01438424|Secondary|Percentage of Participants Who Achieved HBV DNA <300 Copies/mL by PCR Assay, Loss of HBeAG, Seroconversion, and ALT ≤1.0*Upper Limit of Normal (ULN) (Entecavir Continuous Treatment Cohort)|The Entecavir Continuous Treatment Cohort consisted of participants from study AI463-022 (NCT00035633) who were nucleoside-naive HBeAg-positive and enrolled in the current study with ≤35 days off treatment between the last dose in AI463-022 and the first dose in the current. This cohort is considered to be on continuous entecavir treatment and permitted assessment of continuous administration of entecavir in AI463-022 and the current study.|Baseline to Weeks 48, 96, 144, 192, and 240|Participants enrolled from study AI463-022 who were nucleoside-naive, HBeAg-positive and enrolled in the current study with ≤35 days off treatment between the last dose in AI463-022 and the first dose in the current study and were evaluable. (n=number of evaluable participants)||Percentage of participants|||Number
691434|NCT01438424|Primary|Week 144: Number of Participants With Death As Outcome, Any AE, Grade 3-4 AEs, SAEs, Discontinuations Due to AEs, and Abnormalities in Selected Laboratory Test Results|An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Grade 1=mild; Grade 2=moderate; Grade 3=severe; Grade 4=life-threatening or disabling. AST=aspartate aminotransferase; ULN=upper limit of normal.|Continuously from Day 1 through Week 144|Participants enrolled up to Week 144 who received at least 1 dose of study drug in the current study. (n=number of evaluable participants)||Participants|||Number
691435|NCT01438424|Secondary|Overall Study: Percentage of Participants With a Confirmed ≥1 log10 Increase From Nadir in HBV DNA by PCR Assay||Baseline to Week 144|Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants)||Percentage of participants|||Number
691436|NCT01438424|Primary|Overall Study: Number of Participants With Normal Electrolyte and Fasting Glucose Values at Baseline and Abnormalities in Electrolyte and Fasting Glucose Laboratory Test Results at End of Dosing|Hypochloremia: Grade (Gr) 1=90-93; Gr 2=85-<90; Gr 3=80-<85; Gr 4=40-<80. Hyperchloremia: Gr 1=113-<117; Gr 2=117-<121; Gr 3=121-125; Gr 4>125. Hypocarbia: Gr 1=19-21; Gr 2=15-<19; Gr 3=41-45; Gr 4=>45. Hypercarbia: Gr 1=31-36; Gr 2=37-40; Gr 3=41-45; Gr 4=>45. Hyponatremia: Gr 1=130-132; Gr 2=123-<130; Gr 3=116-<123; Gr 4<116. Hypernatremia: Gr 1=148-<151; Gr 2=151-<158; Gr 3=158-165; Gr 4=>165. Hypokalemia: Gr 1=3-3.4; Gr 2=2.5-<3; Gr 3=2-<2.5; Gr 4=<2. Hyperkalemia: Gr 1=5.6-<6.1; G2=6.1-<6.6; Gr 3=6.6-7; Gr 4=>7. Hypoglycemia: Gr 1=55-64; Gr 2=40-<55; Gr 3=30-< 40; G4=-<30. Hyperglycemia: Gr 1=116-<161; Gr 2=161-<251; Gr 3=251-500; Gr 4>500.|Day 1 of treatment through Week 240|Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants)||Participants|||Number
691478|NCT01438229|Other Pre-specified|24hr Ambulatory Systolic BP Change|Average of readings taken every half hour during the course of a 24hr period wearing the ambulatory blood pressure monitor. Includes only subjects who completed the test at both baseline and follow up. If a subject refused to wear the monitor they were excluded.|Baseline to 24 months|||mmHg||Standard Deviation|Mean
699168|NCT01347840|Secondary|Area Under the Curve of Glucose|This variable will measure the combined effects of glucose concentration and duration.|16 months|||units on a scale|||Number
691437|NCT01438424|Primary|Overall Study: Number of Participants With Normal Pancreatic Enzyme and Renal Function Values at Baseline and Abnormalities in Pancreatic Enzyme and Renal Function Laboratory Test Results at End of Dosing|Amylase: Grade 1=1.10-<1.40*ULN; Grade 2=1.40-< 2.10*ULN; Grade 3=2.10-5.00*ULN; Grade 4=>5.00*ULN. Lipase: Grade 1.1-<1.4*ULN; Grade 2=1.4-<2.1*ULN; Grade 3=2.1-5.0*ULN; Grade 4=>5.0*ULN. Creatinine: Grade 1=1.10-< 1.60*ULN; Grade 2=1.60-<3.10*ULN; Grade 3=3.10-6.00*ULN; Grade 4=>6.00*ULN. Blood urea nitrogen (BUN): Grade 1=1.25-<2.60*ULN; Grade 2=2.60-<5.10*ULN; Grade 3=5.10-10*ULN; Grade 4=>10*ULN. ULN=upper limit of normal.|Day 1 of treatment through Week 240|Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants)||Participants|||Number
691438|NCT01438424|Primary|Overall Study: Number of Participants With Normal Hematology Values at Baseline and Abnormalities in Hematology Laboratory Test Results Through Week 240|Hemoglobin (g/dL): Grade (Gr) 1=9.5-11.0; Gr 2=8.0-<9.5; Gr 3=6.5-<8.0; Gr 4=<6.5 White blood cells (cells/mm^3): Gr 1=2,500-<4,000; Gr 2=1,000-<2,500; Gr 3=800-<1,000; Gr 4=<800. Neutrophils (cells/mm^3): Gr 1=1000-<1500; Gr 2=750-<1000; Gr 3=500-<750; Gr 4=<500. Platelets (cells/mm^3): Gr 1=75,000-99,000; Gr 2=50,000-<75,000; Gr 3=20,000-<50,000; Gr 4=<20,000. Prothrombin time (seconds): Gr 1=1.01-<1.26*ULN; Gr 2=1.26-<1.51 *ULN; Gr 3=1.51-3*ULN; Gr 4=>3*ULN. INR: Gr 1=1.24-1.5; Gr 2=1.5-2; Gr 3=2-3; Gr 4=>3. INR=international normalized ratio; ULN=upper limit of normal. .|Day 1 of treatment through Week 240|Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants)||Participants|||Number
691439|NCT01438424|Secondary|Week 192: Percentage of Participants With Improvement in Fibrosis (Efficacy Evaluable Cohort)|The Ishak Modification for Hepatic Activity Index (HAI) scores necroinflammatory activity in chronic hepatitis. 0=no fibrosis, 1=fibrosis expansion of some portal areas, 2=fibrosis expansion of most portal areas, 3=fibrosis expansion of most portal areas with occasional bridging, 4=fibrosis expansion of portal areas with marked bridging, 5=incomplete cirrhosis, 6=probable or definite cirrhosis. Higher score=more severe necrosis. Improvement in fibrosis=≥1-point reduction in HAI score. Cohort participants had to have adequate baseline and long-term biopsy samples and baseline Knodell scores ≥2.|Baseline to Week 192|Subset of participants who who had evaluable paired liver biopsy results at Phase 3 study baseline and on their last observed biopsies performed in the current study. (n=number of evaluable participants)||Percentage of participants||95% Confidence Interval|Number
691440|NCT01438424|Secondary|Week 192: Percentage of Participants With Histologic Improvement (Efficacy Evaluable Cohort)|The Knodell Histologic Activity Index scores stage of necrosis and grade of inflammation in liver biopsies. Components are necrosis near the portal vein, intralobular degeneration and focal necrosis, portal inflammation, and fibrosis. The 4 components are scored from 1 to 4 and 1 to 10 (necrosis near the portal vein) and combined for a total score, with 22 being the highest possible score. Higher the score for each component=greater liver damage. Histologic improvement=a ≥2-point reduction in total Knodell score and no worsening in fibrosis. Cohort participants had to have adequate baseline and long-term biopsy samples and baseline Knodell necroinflammatory scores ≥2.|Baseline to Week 192|Subset of participants who who had evaluable paired liver biopsy results at Phase 3 study baseline and on their last observed biopsies performed in the current study. (n=number of evaluable participants)||Percentage of participants||95% Confidence Interval|Number
691441|NCT01438424|Secondary|Overall Study: Percentage of Participants Who Achieved ALT Normalization|ULN=upper limit of normal. ALT normalization=ALT levels ≤1.0*ULN.|Study entry to Week 216|Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants)||Percentage of participants|||Number
691442|NCT01438424|Secondary|Overall Study: Mean Alanine Transaminase (ALT) Levels|Observed values.|Study entry to Week 216|Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants)||U/L||Standard Deviation|Mean
691443|NCT01438424|Secondary|Overall Study: Percentage of Participants With HBeAg Seroconversion|Observed values. Seroconversion=negative HBeAg with detectable anti-HBe antibody.|Study entry to Week 216|Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants)||Percentage of participants|||Number
691444|NCT01438424|Secondary|Overall Study: Percentage of Participants Who Achieved a Loss of Hepatitis B e Antigen (HBeAg)|Observed values.|Study entry to Week 216|Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants)||Percentage of participants|||Number
691445|NCT01438424|Secondary|Overall Study: Mean HBV DNA Level by PCR Assay||Study entry to Week 216|Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants)||log10 copies/mL||Standard Deviation|Mean
691446|NCT01438424|Primary|Overall Study: Number of Participants With Death As Outcome, Any Adverse Event (AE), Grade 3-4 AEs, Serious Adverse Events (SAEs), and Discontinuations Due to AEs|An AE is a new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not be causally related to treatment. An SAE is an unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Grade 1=mild; Grade 2=moderate; Grade 3=severe; Grade 4=life-threatening or disabling. ALT=alanine transaminase; ULN=upper limit of normal.|Continuously from Day 1 through Week 240|All participants who received at least 1 dose of study drug in the current study.||Participants|||Number
691447|NCT01438424|Secondary|Overall Study: Percentage of Participants by HBV DNA Category by PCR Assay|Observed values.|Baseline to Week 192|Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants)||Percentage of participants|||Number
691448|NCT01438424|Secondary|Overall Study: Percentage of Participants With Sustained HBV DNA <10^4 Copies/mL by PCR Assay||Study entry to Week 192|Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants)||Percentage of participants|||Number
691449|NCT01438424|Secondary|Overall Study: Percentage of Participants With Sustained HBV DNA Level <300 Copies/mL by PCR Assay||Study entry to Week 192|Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants)||Percentage of participants|||Number
691450|NCT01438307|Secondary|Overall Survival|Assessment will be made in subjects with Stage IV NSCLC who receive Cabazitaxel-SRP6258 after progressing with first line platinum-based chemotherapy.|28 months|||months||95% Confidence Interval|Median
703363|NCT00094900|Secondary|Mean Change in Prednisone Dose||24 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||mg/day||Standard Error|Mean
691454|NCT01438294|Other Pre-specified|Energy Expenditure|Was measured using a biaxial accelerometer (SenseWearTM Pro activity monitor, USA) (Kuys et al. 2011). The equipment was always used on the upper right limb for the determination of skin temperature, galvanic skin response and movement. Energy expenditure was calculated in metabolic equivalents (METS) and calories per minute. The SenseWear arm bandTM was used during the exercise sessions as a comparative parameter of effort intensity in the VGG and TG. The energy expenditure at rest, medium and maximum effort was the average of all sessions of all children.|baseline and during all training sessions 8 weeks||||||
691455|NCT01438294|Other Pre-specified|Asthma Control Questionnaire (ACQ6) - Clinical Control of Disease|"Asthma control questionnaire (ACQ) is a standardized toll to assess clinical control in asthmatic patients and consists of 7 questions, 5 related to asthma symptoms, one regarding the use of short- acting ß2 agonists as rescue medication, and one regarding FEV1 before bronchodilator in percent of predicted.
ACQ score is the average these items and ranges from 0 (completely controlled) to 6 (uncontrolled) obtained in a 7 days period. The total points is divided by six to provide the final score ( six questions with range 0 to 6 points, maximal 36 points divided by six maximal 6 and mimimal 0)
The cutoff point for controlled/uncontrolled asthma is 2 points. Patient was classified according ACQ scores into controlled (<0.75), partially controlled (0.75-1.5) and uncontrolled asthma (>1.5). A minimal clinical important difference is 0.5 on a 7-point scale (Juniper et al.2005, Leite et al. 2008 and Ko et al. 2012)."|clinical control week 8|||units on a scale||Inter-Quartile Range|Median
691456|NCT01438294|Secondary|Pulmonary Function|was performed before and after the inhalation of 400μg of salbutamol (Easy One™, USA), and technical procedures were performed as recommended by ATS/ERS. Predicted normal values were those proposed by Polgar and Promadhat 1971 and a 12% and 200 mL increase in FEV1 from baseline were characterized as a positive response to the bronchodilator) in a climate-controlled room.|baseline and after 8 weeks||||||
691457|NCT01438294|Secondary|Body Composition|All participants were evaluated individually, always during the afternoon to avoid circadian changes. Height, weight and abdominal circumference were determined. Tetrapolar bioimpedance was measured using the Biodynamics™ model 310 (Biodynamics Corporation Seattle WA, USA) by positioning the child in the supine position and electrodes in the extremity of the right upper and lower limbs (Goran et al.1993).|baseline and after 8 weeks||||||
691458|NCT01438294|Secondary|Treadmil Test (Bruce Protocol)|"A maximal exercise testing was performed in a treadmill using Bruce protocol that has been used to provide information on exercise capacity, physiopathological characteristics during effort, the efficacy of medications and the potential risk for diseases ( Zijp et al. 2010). The test was interrupted when the child reported maximal fatigue or reached the maximum heart rate around 200bpm (Peyer et al. 2011). During the test, blood pressure and peripheral oxygen saturation were quantified and an electrocardiogram was performed. The Borg scale was used to quantify for the sensation of shortness of breath during effort and at rest (Lamb 1995).
Change from baseline in the distance walked on treadmill test will be consider as outcome measure."|8 week distance walked on treadmill test|||meters||Standard Deviation|Mean
691459|NCT01438294|Primary|Exhaled Nitric Oxide (FeNO) Level|"The measurement of exhaled FeNO level is performed by several commercially available devices, however the equipment NIOX ® (Aerocrine, Sweden) analyzer is the only FDA-approved and Anvisa (Food and Drug Administration) for clinical monitoring of asthma.
The measure will be performed before and after the training program of exercise, or pulmonary rehabilitation, by means of portable equipment NIOX MINO ®."|The FeNO level was performed in week 8|||ppb||Standard Deviation|Mean
691460|NCT01438229|Other Pre-specified|Cystatin C||24 months|||mg/L||Standard Deviation|Mean
691461|NCT01438229|Other Pre-specified|Cystatin C||18 months|||mg/L||Standard Deviation|Mean
691462|NCT01438229|Other Pre-specified|Cystatin C||12 months|||mg/L||Standard Deviation|Mean
691463|NCT01438229|Other Pre-specified|Cystatin C||6 months|||mg/L||Standard Deviation|Mean
691464|NCT01438229|Other Pre-specified|Cystatin C||Baseline|||mg/L||Standard Deviation|Mean
691465|NCT01438229|Other Pre-specified|Estimated Glomular Filtration Rate|"Calculated using Modifide Diet in Renal Disease formula.
estimated GFR = 186 x SerumCr-1.154 * age-0.203 * 1.212 (if patient is black) * 0.742 (if female)"|24 months|||mL/min per 1.73m^2||Standard Deviation|Mean
691466|NCT01438229|Other Pre-specified|Estimated Glomular Filtration Rate|"Calculated using Modifide Diet in Renal Disease formula.
estimated GFR = 186 x SerumCr-1.154 * age-0.203 * 1.212 (if patient is black) * 0.742 (if female)"|18 months|||mL/min per 1.73m^2||Standard Deviation|Mean
691467|NCT01438229|Other Pre-specified|Estimated Glomular Filtration Rate|"Calculated using Modifide Diet in Renal Disease formula.
estimated GFR = 186 x SerumCr-1.154 * age-0.203 * 1.212 (if patient is black) * 0.742 (if female)"|12 months|||mL/min per 1.73m^2||Standard Deviation|Mean
691468|NCT01438229|Other Pre-specified|Estimated Glomular Filtration Rate|"Calculated using Modifide Diet in Renal Disease formula.
estimated GFR = 186 x SerumCr-1.154 * age-0.203 * 1.212 (if patient is black) * 0.742 (if female)"|6 months|||mL/min per 1.73m^2||Standard Deviation|Mean
691469|NCT01438229|Other Pre-specified|Estimated Glomular Filtration Rate|"Calculated using Modifide Diet in Renal Disease formula.
estimated GFR = 186 x SerumCr-1.154 * age-0.203 * 1.212 (if patient is black) * 0.742 (if female)"|Baseline|||mL/min per 1.73m^2||Standard Deviation|Mean
691470|NCT01438229|Other Pre-specified|Urine Albumin to Creatinine Ratio||24 months|||mg/g||Standard Deviation|Mean
691471|NCT01438229|Other Pre-specified|Urine Albumin to Creatinine Ratio||18 months|||mg/g||Standard Deviation|Mean
691472|NCT01438229|Other Pre-specified|Urine Albumin to Creatinine Ratio||12 months|||mg/g||Standard Deviation|Mean
691473|NCT01438229|Other Pre-specified|Urine Albumin to Creatinine Ratio||6 months|||mg/g||Standard Deviation|Mean
691474|NCT01438229|Other Pre-specified|Urine Albumin to Creatinine Ratio||Baseline|||mg/g||Standard Deviation|Mean
691475|NCT01438229|Other Pre-specified|24hr Ambulatory Diastolic BP Change|Average of readings taken every half hour during the course of a 24hr period wearing the ambulatory blood pressure monitor. Includes only subjects who completed the test at both baseline and follow up. If a subject refused to wear the monitor they were excluded.|Baseline to 24 months|||mmHg||Standard Deviation|Mean
691476|NCT01438229|Other Pre-specified|24hr Ambulatory Diastolic BP Change|Average of readings taken every half hour during the course of a 24hr period wearing the ambulatory blood pressure monitor. Includes only subjects who completed the test at both baseline and follow up. If a subject refused to wear the monitor they were excluded.|Baseline to 12 months|||mmHg||Standard Deviation|Mean
691480|NCT01438229|Other Pre-specified|24hr Ambulatory Systolic BP Change|Average of readings taken every half hour during the course of a 24hr period wearing the ambulatory blood pressure monitor. Includes only subjects who completed the test at both baseline and follow up. If a subject refused to wear the monitor they were excluded.|Baseline to 6 months|||mmHg||Standard Deviation|Mean
691481|NCT01438229|Other Pre-specified|Office Diastolic BP Change||Baseline to 24 months|||mmHg||Standard Deviation|Mean
691482|NCT01438229|Other Pre-specified|Office Diastolic BP Change||Baseline to 18 months|||mmHg||Standard Deviation|Mean
691483|NCT01438229|Other Pre-specified|Office Diastolic BP Change||Baseline to 12 months|||mmHg||Standard Deviation|Mean
691484|NCT01438229|Other Pre-specified|Office Systolic BP Change||Baseline to 24 months|||mmHg||Standard Deviation|Mean
691485|NCT01438229|Other Pre-specified|Office Systolic BP Change||Baseline to 18 months|||mmHg||Standard Deviation|Mean
691486|NCT01438229|Other Pre-specified|Office Systolic BP Change||Baseline to 12M|||mmHg||Standard Deviation|Mean
691487|NCT01438229|Other Pre-specified|Office Diastolic BP Change||Baseline to 6M|||mmHg||Standard Deviation|Mean
691488|NCT01438229|Primary|Office Systolic Blood Pressure Change||Baseline to 6 months|Subjects with both baseline and 6M follow up office blood pressure measurements||mmHg||Standard Deviation|Mean
691489|NCT01438229|Primary|Adverse Events|All device or procedure related adverse events|24 months|All subjects receiving renal artery ablation procedure||percentage of participants|||Number
691490|NCT01438177|Secondary|Median Duration of Response of This Regimen|Duration of response is the time from response (CR or PR) until progression of disease or relapse. Responses and progression were evaluated based on the criteria published by the International Myeloma Working Group (Durie, et al, 2006).|up to 2 years|patients who have responded||months||Full Range|Median
691491|NCT01438177|Secondary|Percentage of Subjects Who Have Complete Response or Partial Response and Have 2+ or Higher Autophagy||until clinical response (up to 2 years)||||||
691492|NCT01438177|Secondary|Number of Participants With Adverse Events of Grade 3 or Higher|Adverse events reported here were at least possibly related to the protocol therapy.|Treatment period plus 30 days post-treatment|Any patients who started the treatment||participants|||Number
691493|NCT01438177|Primary|Response Rate (CR + PR After 2 Cycles)|"Response rate is defined as the percentage of patients who have a complete response (CR) or partial response (PR). Responses were assessed every two cycles of treatment, based on the criteria published by the International Myeloma Working Group (Durie, et al, 2006). Per International Myeloma Working Group response criteria:
CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow PR: > 50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by >90% or to < 200 mg/24 h"|Up to 2 years|Evaluable patients.||percentage of participants|||Number
691494|NCT01438151|Primary|Remicade Dose Escalation|At visit 1 and 2, Remicade given at 5mg/kg. If there is no response to treatment, or flare at any visit (beginning at visit #3), infliximab dose or dosing frequency will be increased in a gradual fashion, up to a maximum of 15 mg/kg every 6 weeks, until response is achieved.|2/16/12-3/22/13|||participants|||Number
691495|NCT01438060|Secondary|Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AE During Treatment Beyond 140 Weeks|AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|Week 140 to Week 328|Participants in France who completed the 130-week open-label extension phase and continued beyond Week 140 were included in safety sample.||Participants|||Number
691496|NCT01438060|Secondary|Participants With Potentially Clinically Significant Laboratory Abnormalities During Extension Phase|Criteria for identifying potentially clinically significant laboratory values were based on guidelines suggested by the FDA Division of Neuropharmacological Drug Products.|Week 11 to Week 140|All the 161 participants (80 in placebo and 81 in aripiprazole group) were included in the Extension Phase Safety Sample.||Participants|||Number
691497|NCT01438060|Secondary|Participants With a Potentially Clinically Significant Electrocardiogram Abnormalities During Extension Phase|Bradycardia:Heart rate ≤50 bpm and ≥15 bpm decrease from baseline; Supraventricular premature beat: ≥2 per 10 seconds and any increase from baseline; 1st degree A-V Block: PR ≥0.20 seconds and increase of ≥0.05 second from baseline; Intraventricular conduction block:QRS ≥0.12 second and increase of ≥0.02 second from baseline; QTcB= ≥450 msec and ≥10% increase from baseline; QTcN =≥450 msec and ≥10% increase from baseline. All other events were not present at baseline but observed during the study|Week 11 to Week 140|All the 161 participants (80 in placebo and 81 in aripiprazole group) were included in the Extension Phase Safety Sample.||Participants|||Number
691498|NCT01438060|Secondary|Participants With a Potentially Clinically Significant Vital Sign Abnormality During Extension Phase|Systolic BP: increase defined as ≥180 and a ≥20-mmHg increase from baseline (BL); decrease defined as ≤90 and a ≤20mmHg decrease from BL. Diastolic BP: increase defined as ≥105 and a ≥15mmHg decrease from BL, decrease defined as ≤50 and a ≤15mmHg decrease from BL. Heart rate: increase defined as ≥120 and ≥15bpm increase from bBL, decrease defined as ≤50 and ≤15bpm decrease from BL; Weight: increase defined as ≥7% from baseline, decrease defined as ≤7% decrease BL. Criteria for identifying PCS measurements based on guidelines suggested by the FDA Division of Neuropharmacological Drug Products|Week 11 to Week 140|All the 161 participants (80 in placebo and 81 in aripiprazole group) were included in the Extension Phase Safety Sample.||Participants|||Number
691499|NCT01438060|Secondary|Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AE During Extension Phase|AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|Week 11 to Week 140|All the 161 participants (80 in placebo and 81 in aripiprazole group)were included in the Extension Phase Safety Sample.||Participants|||Number
691500|NCT01438060|Secondary|Participants With Extrapyramidal Symptoms (EPS) Related Adverse Events During Extension Phase|Extrapyramidal symptoms (EPS) are various movement disorders such as acute dystonic reactions, pseudoparkinsonism, or akathisia|Week 11 to Week 140|All the 161 participants (80 in placebo and 81 in aripiprazole group)were included in the Extension Phase Safety Sample.||Participants|||Number
691501|NCT01438060|Secondary|Change in Barnes Global Clinical Assessment of Akathisia Score During Extension Phase|The Barnes Akathisia Rating Scale is a 4-item scale to assess presence and severity of drug-induced akathisia, including both objective items and subjective items, together with a global clinical assessment of akathisia. Global assessment is made on a scale of 0 to 5 with comprehensive definitions provided for each anchor point on scale: 0=absent; 1=questionable; 2=mild akathisia; 3=moderate akathisia; 4=marked akathisia; 5=severe akathisia. Score has a possible range from 0 (absent) to 5 (severe akathisia). Negative change scores indicate improvement in akathisia.|End of Acute Phase (Week 10), Weeks 18,26, 40, 52|"Observed Cases data set, Efficacy Sample. n=participants with both post-baseline and baseline values.
Of the 161 participants, 158 were included in the Extension Phase Efficacy Sample, (3 treated participants had no efficacy measurements)."||units on a scale||Standard Error|Mean
691502|NCT01438060|Secondary|Change in Simpson-Angus Scale (SAS) Total Score During Extension Phase|The SAS is a 10-item instrument used to evaluate the presence and severity of parkinsonian symptomatology. It is the most commonly used rating scale for Parkinsonism in clinical trials over the past 25 years. The ten items focus on rigidity rather than bradykinesia, and do not assess subjective rigidity or slowness. Items are rated for severity on a 0-4 scale, with definitions given for each anchor point. The total SAS Score has a possible range from 10 to 50 (lower score=less severe). Negative change scores indicate improvement.|End of Acute Phase (Week 10), Weeks 18,26, 40, 52|"Observed Cases data set, Efficacy Sample. n=participants with both post-baseline and baseline values.
Of the 161 participants, 158 were included in the Extension Phase Efficacy Sample, (3 treated participants had no efficacy measurements)."||Units on Scale||Standard Error|Mean
691503|NCT01438060|Secondary|Change in Abnormal Involuntary Movement Scale (AIMS) Total Score During Extension Phase|"AIMS is a rating scale that was designed to measure involuntary movements (tardive dyskinesia). The AIMS test has a total of twelve items rating involuntary movements of various areas of the patient's body. These items are rated on a five-point scale of severity from 0–4. The scale is rated from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe).
AIMS Total Score is from 0 to 28. A negative change score signifies improvement."|End of Acute Phase (Week 10), Weeks 14, 18, 22, 26, 30, 34, 40, 46, 52, 68, 84, 100, 116, 140|"Observed Cases data set, Efficacy Sample. n=participants with both post-baseline and baseline values.
Of the 161 participants (80 in placebo and 81 in aripiprazole group), 158 were included in the Extension Phase Efficacy Sample, (3 treated participants had no efficacy measurements)."||Units on Scale||Standard Error|Mean
691504|NCT01438060|Secondary|Clinical Global Impression (CGI) Improvement Score During Extension Phase|The CGI rating scale, which measures symptom severity, treatment response and the efficacy of treatments, is used in clinical studies on mental disorders. CGI Improvement scale is a 7 point scale that requires the clinician to assess how much the participant’s illness has improved or worsened relative to a baseline state at the beginning of the intervention: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.|Weeks 12, 14, 18, 22, 26, 30, 34, 40, 46, 52, 68, 84, 100, 116, 132, 140|"Observed Cases data set, Efficacy Sample. n=participants with both post-baseline and baseline values.
Of the 161 participants, 158 were included in the Extension Phase Efficacy Sample, (3 treated participants had no efficacy measurements)."||Units on Scale||Standard Error|Mean
691505|NCT01438060|Secondary|Change in Neuropsychiatric Inventory (NPI) Psychosis Subscale Score From Baseline During Extension Phase|The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 behavioral domains there are 4 scores: Frequency (scale:1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing).The NPI Psychosis Subscale consists of the two domains of Delusions and Hallucinations, calculated by adding the Individual Item Scores, to yield a possible total score of 0 to 24. Lower score=less severity. A negative change score from baseline indicates improvement.|Baseline (Day 0), Weeks 18,26,40,52,68,84,100,116,132,140|"Observed Cases data set, Efficacy Sample. n=participants with both post-baseline and baseline values
Of the 161 participants (80 in placebo and 81 in aripiprazole group), 158 were included in the Extension Phase Efficacy Sample, (3 treated participants had no efficacy measurements)."||Units on a Scale||Standard Error|Mean
691506|NCT01438060|Secondary|Participants With Potentially Clinically Significant Electrocardiogram Abnormalities in Acute Phase|Bradycardia:Heart rate ≤50 bpm and ≥15 bpm decrease from baseline; Supraventricular premature beat: ≥2 per 10 seconds and any increase from baseline; 1st degree A-V Block: PR ≥0.20 seconds and increase of ≥0.05 second from baseline; Intraventricular conduction block:QRS ≥0.12 second and increase of ≥0.02 second from baseline; QTcB= ≥450 msec and ≥10% increase from baseline; QTcN =≥450 msec and ≥10% increase from baseline. All other events were not present at baseline but observed during the study. Inc=increase|Week 1 to Week 10|Of the 208 randomized participants, one (randomized to aripiprazole) was excluded from the Safety Sample as the participant withdrew consent prior to receiving study medication. n=Participants who were evaluated for electrocardiogram||Participants|||Number
691507|NCT01438060|Secondary|Participants With Potentially Clinically Significant (PCS) Vital Sign Abnormalities in Acute Phase|Systolic BP: increase defined as ≥180 and a ≥20-mmHg increase from baseline (BL); decrease defined as ≤90 and a ≥20mmHg decrease from BL. Diastolic BP: increase defined as ≥105 and a ≥15mmHg decrease from BL, decrease defined as ≤50 and a ≥15mmHg decrease from BL. Heart rate: increase defined as ≥120 and ≥15bpm increase from BL, decrease defined as ≤50 and ≥15bpm decrease from BL; Weight: increase defined as ≥7% from BL, decrease defined as ≤7% decrease BL. Criteria for identifying PCS measurements are based on guidelines suggested by the FDA Division of Neuropharmacological Drug Products|Week 1 to week 10|Of the 208 randomized participants, one (randomized to aripiprazole) was excluded from the Safety Sample as the participant withdrew consent prior to receiving study medication. n=Participants with values for vital signs||Participants|||Number
691539|NCT01437995|Secondary|Rate of Episodes of Poor Asthma Control|Rate of episodes of poor asthma control (EPAC) defined by unscheduled medical care, hospitalization, use of oral corticosteroids and/or increased use of rescue medications and/or decrease of 30% or more in morning peak expiratory flow rate|48 weeks|||Episodes of poor asthma control|||Number
691508|NCT01438060|Secondary|Participants With Potentially Clinically Significant Laboratory Abnormalities in Acute Phase|Criteria for identifying potentially clinically significant laboratory values were based on guidelines suggested by the FDA Division of Neuropharmacological Drug Products. Normal ranges are local lab data and vary according to the site. M=male, F=female. Criteria for hematocrit also includes a 3 point shift from baseline.|Week 1 to Week 10|Of the 208 randomized participants, one (randomized to aripiprazole) was excluded from the Safety Sample as the participant withdrew consent prior to receiving study medication. n=Participants with values for laboratory findings||Participants|||Number
691509|NCT01438060|Secondary|Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AEs in Acute Phase|AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|Week 1 to week 10|Of the 208 randomized participants, one (randomized to aripiprazole) was excluded from the Safety Sample as the participant withdrew consent prior to receiving study medication.||Participants|||Number
691510|NCT01438060|Secondary|Participants With Extrapyramidal Symptoms (EPS) Related Adverse Events in Acute Phase|Extrapyramidal symptoms (EPS) are various movement disorders such as acute dystonic reactions, pseudoparkinsonism, or akathisia|Week 1 to week 10|Of the 208 randomized participants, one (randomized to aripiprazole) was excluded from the Safety Sample as the participant withdrew consent prior to receiving study medication.||Participants|||Number
691511|NCT01438060|Secondary|Change From Baseline in Barnes Global Clinical Assessment of Akathisia in Acute Phase|The Barnes Akathisia Rating Scale is a 4-item scale to assess presence and severity of drug-induced akathisia, including both objective items and subjective items, together with a global clinical assessment of akathisia. Global assessment is made on a scale of 0 to 5 with comprehensive definitions provided for each anchor point on scale: 0=absent; 1=questionable; 2=mild akathisia; 3=moderate akathisia; 4=marked akathisia; 5=severe akathisia. Score has a possible range from 0 (absent) to 5 (severe akathisia). Negative change scores indicate improvement in akathisia.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"Observed cases data set, efficacy sample. n=Participants with both post-baseline and baseline measures.
Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"||Unit on scale||95% Confidence Interval|Mean
691512|NCT01438060|Secondary|Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score in Acute Phase|"The Abnormal Involuntary Movement Scale (AIMS) is a rating scale that was designed to measure involuntary movements (tardive dyskinesia). The AIMS test has a total of twelve items rating involuntary movements of various areas of the patient's body. These items are rated on a five-point scale of severity from 0–4. The scale is rated from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe).
AIMS Total Score is from 0 to 28. A negative change score signifies improvement."|Baseline (Day 0), Weeks 2, 4, 8, and 10|"Observed Cased data set, efficacy sample. n=Participants who had both post baseline and baseline values.
Of the 208 randomized participants, 5 were excluded from the efficacy data set: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"||Units on scale||95% Confidence Interval|Mean
691513|NCT01438060|Secondary|Change From Baseline in Simpson-Angus Scale (SAS) Total Score in Acute Phase|The SAS is a 10-item instrument used to evaluate the presence and severity of parkinsonian symptomatology. It is the most commonly used rating scale for Parkinsonism in clinical trials over the past 25 years. The ten items focus on rigidity rather than bradykinesia, and do not assess subjective rigidity or slowness. Items are rated for severity on a 0-4 scale, with definitions given for each anchor point. The total SAS Score has a possible range from 10 to 50.(lower score=less severe). Negative change scores indicate improvement.|Baseline (Day 0), Weeks 2, 4, and 10|"Observed cases data set, Efficacy Sample. n=Participants who had both post baseline and baseline values.
Of the 208 randomized participants, 5 were excluded from the efficacy data set: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"||Units on scale||95% Confidence Interval|Mean
691514|NCT01438060|Secondary|Change From Baseline in NPI Individual Item Scores in Acute Phase: Sleep|The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.
Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"||Units on a Scale||95% Confidence Interval|Mean
691515|NCT01438060|Secondary|Change From Baseline in NPI Individual Item Scores in Acute Phase: Appetite/Eating Behaviors|The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.
Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"||Units on a Scale||95% Confidence Interval|Mean
691540|NCT01437995|Secondary|Pulmonary Function- Change in Peak Expiratory Flow|Change in morning peak expiratory flow rate from the patients' daily diary cards, calculated at 48 weeks minus baseline (randomization)|Baseline and 48 weeks|||Liters per minute||95% Confidence Interval|Median
691541|NCT01437995|Primary|Treatment Failure|Rate of treatment failures assessed by decline in peak flow or FEV1, increased need for beta agonists, requirement for non-scheduled medical care for asthma symptoms, or prednisone taper.|48 weeks|||participants|||Number
691516|NCT01438060|Secondary|Change From Baseline in NPI Individual Item Scores in Acute Phase: Aberrant Motor Behavior|The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.
Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"||Units on a Scale||95% Confidence Interval|Mean
691517|NCT01438060|Secondary|Change From Baseline in NPI Individual Item Scores in Acute Phase: Irritability/Lability|The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.
Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"||Units on a Scale||95% Confidence Interval|Mean
691518|NCT01438060|Secondary|Change From Baseline in NPI Individual Item Scores in Acute Phase: Disinhibition|The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.
Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"||Units on a Scale||95% Confidence Interval|Mean
691519|NCT01438060|Secondary|Change From Baseline in NPI Individual Item Scores in Acute Phase: Elation/Euphoria|The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.
Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"||Units on a Scale||95% Confidence Interval|Mean
691520|NCT01438060|Secondary|Change From Baseline in NPI Individual Item Scores in Acute Phase: Apathy/Indifference|The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.
Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"||Units on a Scale||95% Confidence Interval|Mean
691521|NCT01438060|Secondary|Change From Baseline in NPI Individual Item Scores in Acute Phase: Anxiety|The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.
Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"||Units on a Scale||95% Confidence Interval|Mean
691522|NCT01438060|Secondary|Change From Baseline in NPI Individual Item Scores in Acute Phase: Depression/Dysphoria|The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.
Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"||Units on a Scale||95% Confidence Interval|Mean
691542|NCT01437943|Primary|Effect of Aliskiren on Kidney Metabolism|Evaluation of aliskiren on kidney metabolism by P-MR spectroscopy|180 days (completion of treatment)|Only one subject completed study drug and no subjects had completed the 6 month P-MR scan at the time the trial was terminated. Because of this, we were not able to analyze the primary outcome.|||||
703364|NCT00094900|Secondary|Mean Change in Prednisone Dose||12 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||mg/day||Standard Error|Mean
691523|NCT01438060|Secondary|Change From Baseline in NPI Individual Item Scores in Acute Phase: Agitation/Aggression|The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.
Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"||Units on a Scale||95% Confidence Interval|Mean
691524|NCT01438060|Secondary|Change From Baseline in NPI Individual Item Scores in Acute Phase: Hallucinations|The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.
Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"||Units on a Scale||95% Confidence Interval|Mean
691525|NCT01438060|Secondary|Change From Baseline in NPI Individual Item Scores in Acute Phase: Delusions|The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.
Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"||Units on a Scale||95% Confidence Interval|Mean
691526|NCT01438060|Secondary|Change From Baseline in Mini Mental State Examination (MMSE) Total Score in Acute Phase|The MMSE is a screening test for cognitive dysfunction. The test consists of five sections (orientation, registration, attention-calculation, recall, and language). It is a 19 item scale, the total score can range from 0 to 30, with a higher score indicating better function. A positive change score indicates improvement from baseline.|Baseline (Day 0), Week 10|"LOCF data set, efficacy sample. n=Participants who had both post baseline and baseline values.
Of the 208 randomized participants, 5 were excluded from the efficacy data set: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"||Units on Scale||Standard Error|Mean
691527|NCT01438060|Secondary|Change From Baseline in Brief Psychiatric Rating Scale (BPRS) Total Score in Acute Phase|"The BPRS is designed to measure clinical change in participants and is used as a global measure of psychopathology. The BPRS includes 18 items with items devoted to hallucinatory behavior, suspiciousness, unusual thought content, etc. BPRS is an 18-item clinician rated scale with 11 general symptom items, 5 positive-symptom items, and 2 negative symptom items scored on a 7-point scale (1=not present and 7=extremely severe), with higher score indicating greater severity of symptom. Total possible score range=18 to 126.
A negative change score signifies improvement."|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample. n = Participants who had both post baseline and baseline values.
Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"||Unit on Scale||95% Confidence Interval|Mean
691528|NCT01438060|Secondary|CGI Improvement Score in Acute Phase|The CGI rating scale, which measures symptom severity, treatment response and the efficacy of treatments, is used in clinical studies on mental disorders. CGI Improvement scale is a 7 point scale that requires the clinician to assess how much the participant’s illness has improved or worsened relative to a baseline state at the beginning of the intervention: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.|Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample. n = Participants who had both post baseline and baseline values.
Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"||Units on Scale||Standard Error|Mean
691529|NCT01438060|Secondary|Change From Baseline in Clinical Global Impression (CGI) Severity of Illness Score in Acute Phase|The CGI rating scale, which measures symptom severity, treatment response and the efficacy of treatments, is used in clinical studies on mental disorders. CGI Severity scale is a 7-point scale that requires the clinician to rate the severity of the illness at the time of assessment, relative to the clinician's past experience with participants who have the same diagnosis. The assessment is based on severity of mental illness at the time of rating, 0=not assessed, 1=normal, 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; or 7=extremely ill.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.
Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2). An additional participant did not have CGI-Severity score and was not included in the analysis"||Units on Scale||95% Confidence Interval|Mean
691543|NCT01437878|Secondary|Change in Minute Ventilation|Change from baseline to week 4. Minute ventilation was measured during incremental and constant work rate exercise testing.|Baseline to week 4|The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.|||||
697097|NCT01370408|Secondary|Complete Remission During Overall Chemotherapy Time Period|Proportion of patients achieving a CR during the cumulative overall 0-120 hour time period|120 hours|||participants|||Number
691530|NCT01438060|Secondary|Change From Baseline in NPI Total Caregiver Distress Score in Acute Phase|The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 behavioral domains there are 4 scores: Frequency (scale: 1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing).The total NPI Caregiver Distress Score is calculated by adding the 12 Caregiver Distress Individual Item Scores, to yield a possible total score of 0 to 60. Lower score=less severity. A negative change score from baseline indicates improvement.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.
Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"||Units on a Scale||95% Confidence Interval|Mean
691531|NCT01438060|Secondary|Change From Baseline in NPI Psychosis Subscale Caregiver Distress Score in Acute Phase|The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 behavioral domains there are 4 scores: Frequency (scale:1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale:0=not at all distressing to 5=extremely distressing). The NPI Psychosis Subscale Caregiver Distress Score is calculated by adding Individual Item Scores for the domains of Delusions and Hallucinations, to yield a possible total score of 0 to 10. Lower score=less severity. A negative change score from baseline=improvement.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.
Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"||Unit on a Scale||95% Confidence Interval|Mean
691532|NCT01438060|Secondary|Participants Who Demonstrated a ≥ 50% Decrease From Baseline in the Total NPI Score in Acute Phase|The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 behavioral domains there are 4 scores: Frequency (scale: 1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing).The NPI Total Score is calculated by adding the Individual Item Scores for all 12 domains, to yield a possible NPI Total Score of 0 to 144. Lower score=less severity. A negative change score from baseline indicates improvement.|Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.
Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"||Participants|||Number
691533|NCT01438060|Secondary|Participants Who Demonstrated a ≥ 50% Decrease From Baseline to Endpoint in the NPI Psychosis Subscale Score in Acute Phase|The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 behavioral domains there are 4 scores: Frequency (scale:1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing).The NPI Psychosis Subscale consists of the two domains of Delusions and Hallucinations, calculated by adding the Individual Item Scores, to yield a possible total score of 0 to 24. Lower score=less severity. A negative change score from baseline indicates improvement.|Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.
Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"||Participants|||Number
691534|NCT01438060|Secondary|Change From Baseline in NPI Total Score in Acute Phase|The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 behavioral domains there are 4 scores: Frequency (scale: 1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing).The NPI Total Score is calculated by adding the Individual Item Scores for all 12 domains, to yield a possible NPI Total Score of 0 to 144. Lower score=less severity. A negative change score from baseline indicates improvement.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.
Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"||Units on a Scale||95% Confidence Interval|Mean
691535|NCT01438060|Secondary|Change From Baseline in NPI Psychosis Subscale Score Through Week 8 in Acute Phase|The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 behavioral domains there are 4 scores: Frequency (scale:1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing).The NPI Psychosis Subscale consists of the two domains of Delusions and Hallucinations, calculated by adding the Individual Item Scores, to yield a possible total score of 0 to 24. Lower score=less severity. A negative change score from baseline indicates improvement.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, and 8|"LOCF data set, efficacy sample.
Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"||Units on Scale||95% Confidence Interval|Mean
691536|NCT01438060|Primary|Change From Baseline in Neuropsychiatric Inventory (NPI) Psychosis Subscale Score at Week 10 in Acute Phase|The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 behavioral domains there are 4 scores: Frequency (scale:1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing).The NPI Psychosis Subscale consists of the two domains of Delusions and Hallucinations, calculated by adding the Individual Item Scores, to yield a possible total score of 0 to 24. Lower score=less severity. A negative change score from baseline indicates improvement.|Baseline (Day 0), Week 10|"Last Observation Carried forward (LOCF) data set, efficacy sample.
Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"||Units on a scale||Standard Error|Mean
691537|NCT01437995|Secondary|Pulmonary Function: Change in FEV1/FVC Ratio|Change in participant's FEV1/FVC ratio calculated as 48 weeks minus baseline.|Baseline and 48 weeks|||ratio||95% Confidence Interval|Median
691538|NCT01437995|Secondary|Change in Pulmonary Function: FEV1 and FVC|Change in participant's pre-bronchodilator pulmonary function tests (FEV1 and FVC) calculated as 48 weeks minus baseline.|Baseline and 48 weeks|||Liters||95% Confidence Interval|Median
703365|NCT00094900|Secondary|Mean Change in Prednisone Dose||6 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||mg/day||Standard Error|Mean
691544|NCT01437878|Secondary|Change in Tidal Volume|Change from baseline to week 4. Tidal volume was measured during incremental and constant work rate exercise testing.|Baseline to week 4|The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.|||||
691545|NCT01437878|Secondary|Change in Arterial Oxygen Saturation as Indicated by Pulse Oximetry|Change from baseline to week 4. Arterial oxygen was determined by pulse oximetry during incremental and constant work rate exercise testing.|Baseline to week 4|The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.|||||
691546|NCT01437878|Secondary|Change in Heart Rate|Change from baseline to week 4. Heart rate was measured during incremental and constant work rate exercise testing.|Baseline to week 4|The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.|||||
691547|NCT01437878|Secondary|Change in Oxygen Uptake Per Heartbeat|Change from baseline to week 4. Pulmonary gas exchange was measured during incremental and constant work rate exercise testing.|Baseline to week 4|The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.|||||
691548|NCT01437878|Secondary|Change in Carbon Dioxide Output|Change from baseline to week 4. Pulmonary gas exchange was measured during incremental and constant work rate exercise testing.|Baseline to week 4|The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.|||||
691549|NCT01437878|Secondary|Change in Oxygen Uptake|Change from baseline to week 4. Pulmonary gas exchange was measured during incremental and constant work rate exercise testing.|Baseline to week 4|The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.|||||
691550|NCT01437878|Secondary|Change in End Tidal Partial Pressure of Oxygen|Change from baseline to week 4. Pulmonary gas exchange was measured during incremental and constant work rate exercise testing.|Baseline to week 4|The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.|||||
691551|NCT01437878|Secondary|Change in End Tidal Partial Pressure of Carbon Dioxide|Change from baseline to week 4. Pulmonary gas exchange was measured during incremental and constant work rate exercise testing.|Baseline to week 4|The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.|||||
691552|NCT01437878|Secondary|Change in Pulmonary Vascular Resistance|On Day 1 patients underwent acute hemodynamic testing prior to and immediately after (no more than 15 minutes) the first dose of inhaled iloprost or placebo. All hemodynamic variables were measured using a Swan-Ganz catheter.|15 minutes|The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.|||||
691553|NCT01437878|Secondary|Change in Right Ventricular Pressure|On Day 1 patients underwent acute hemodynamic testing prior to and immediately after (no more than 15 minutes) the first dose of inhaled iloprost or placebo. All hemodynamic variables were measured using a Swan-Ganz catheter.|15 minutes|The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.|||||
691554|NCT01437878|Secondary|Change in Cardiac Output|On Day 1 patients underwent acute hemodynamic testing prior to and immediately after (no more than 15 minutes) the first dose of inhaled iloprost or placebo. All hemodynamic variables were measured using a Swan-Ganz catheter.|15 minutes|The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.|||||
691555|NCT01437878|Secondary|Change in Mean Right Atrial Pressure|On Day 1 patients underwent acute hemodynamic testing prior to and immediately after (no more than 15 minutes) the first dose of inhaled iloprost or placebo. All hemodynamic variables were measured using a Swan-Ganz catheter.|15 minutes|The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.|||||
738603|NCT00450749|Secondary|Histological Characteristics of Prostatic Surgical Tissue||At 4-7 weeks||||||
691556|NCT01437878|Secondary|Change in Mean Pulmonary Arterial Pressure|On Day 1 patients underwent acute hemodynamic testing prior to and immediately after (no more than 15 minutes) the first dose of inhaled iloprost or placebo. All hemodynamic variables were measured using a Swan-Ganz catheter.|15 minutes|The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.|||||
691557|NCT01437878|Secondary|Change in Diastolic Pulmonary Arterial Pressure|On Day 1 patients underwent acute hemodynamic testing prior to and immediately after (no more than 15 minutes) the first dose of inhaled iloprost or placebo. All hemodynamic variables were measured using a Swan-Ganz catheter.|15 minutes|The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.|||||
691558|NCT01437878|Secondary|Change in Systolic Pulmonary Arterial Pressure|On Day 1 patients underwent acute hemodynamic testing prior to and immediately after (no more than 15 minutes) the first dose of inhaled iloprost or placebo. All hemodynamic variables were measured using a Swan-Ganz catheter.|15 minutes|The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.|||||
691559|NCT01437878|Secondary|Participants With Treatment-emergent Adverse Events|Treatment-emergent adverse events up to 24 hours post-end of treatment (EOT), approximately 4 weeks|Baseline up to 24 hours post-EOT, approximately 4 weeks|Total population||participants|||Number
691560|NCT01437878|Primary|Change in Endurance Time|Change from baseline to week 4 in endurance time during constant work rate exercise testing|Baseline to week 4|The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.|||||
691561|NCT01437540|Secondary|Percentage of Patients to Experience Potentially Clinically Significant Changes in ECG From Baseline|Potentially clinically significant changes were defined as listed in the table below for QT interval, QTcB, QTcF, QRS interval, PR interval and heart rate (HR)|Up to study Week 56 ± 3 days|Patients with baseline and at least 1 post-baseline assessment value for each parameter||Percentage of patients|||Number
691562|NCT01437540|Secondary|Percentage of Patients to Experience a Potentially Clinically Significant (PCS) Change in Pulse Rate, Systolic and Diastolic Blood Pressure|Systolic BP ≥180 mmHg and increase ≥20 mmHg from baseline or ≤90 mmHg and decrease ≥20 mmHg from baseline; Diastolic BP ≥105 mmHg and increase ≥15 mmHg from baseline or ≤50 mmHg and decrease ≥15 mmHg from baseline; Pulse rate ≥ 110 bpm and increase ≥ 15% from baseline or ≤ 50 bpm and decrease ≥15% from baseline|Up to study Week 56 ± 3 days|Patients with baseline and at least 1 post-baseline assessment of vital signs for each parameter||Percentage of patients|||Number
691563|NCT01437540|Secondary|Percentage of Patients to Experience Any Potentially Clinically Significant (PCS) Post-baseline Change in Clinical Laboratory Values for Hematology, Chemistry or Urinalysis at the End of the Study|"<0.85 x lower limit of normal (LLN) or > 1.15 upper limit of normal (ULN) for hemoglobin, hematocrit, red blood cell, platelet, white blood cell, neutrophil and lymphocyte counts >1.15 × ULN for eosinophil, basophil and monocyte counts
>1.15 x ULN for aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma glutamyl transferase, total bilirubin, creatinine kinase, lactate dehydrogenase, blood urea nitrogen, creatinine, uric acid, total cholesterol, triglycerides <0.85 x LLN or >1.15 ULN for fasting glucose, calcium, phosphorus, total protein and albumin <0.95 x LLN or >1.05 x ULN for sodium, potassium and chloride
Urinary blood, ketones or pH <0.85 x LLN or > 1.15 ULN"|Up to study Week 52|Patients with available non-potentially clinically significant baseline value and at least one post-baseline assessment||Percentage of participants|||Number
691564|NCT01437540|Primary|Percentage of Patients to Experience at Least One Treatment-emergent Adverse Event (TEAE)|TEAEs were coded Version 16.0 of the Medical Dictionary for Regulatory Activities (MedDRA)|Up to study Week 56 ± 3 days|Safety Population defined as all randomized patients who took at least one dose of double-blind investigational product||Percentage of participants|||Number
691565|NCT01437501|Secondary|Change From Baseline in Levels of Glucoraphanin/Sulforaphane and Their Metabolites Over Intervention Period||Endpoints assessed on urine and blood samples collected during the intervention on weeks 0, 1, 2, 4, 6, 8, 10 and 12.||01/2014||||
691566|NCT01437501|Primary|Effect of Treatment on Levels of Air Toxics Mercapturic Acids Over Intervention Period|Urinary excretion of benzene mercapturic acid (S-PMA) in 12 hour overnight void at 12 weeks|Endpoints were assessed on urine samples collected at the end of the intervention on week 12.|Analyses were conducted on all urine samples provided by study participants at week 12.||pmol/mg creatinine||Inter-Quartile Range|Median
691567|NCT01437488|Secondary|Progression Free Survival|To determine the progression free survival (PFS) of patients with advanced or recurrent urothelial carcinoma who have previously been treated with a platinum based regimen while on treatment with cabazitaxel. Defined as a 20% increase in the largest diameter of the largest lesion by CT scan.|Every 3 cycles or 63 days|||Participants|||Count of Participants
691568|NCT01437488|Secondary|Overall Survival|To determine the percentage of patients alive at 12 months from trial entry. Overall survival will be measured from date of randomization to date of death due to any cause.|At 12 months|||Participants|||Count of Participants
691569|NCT01437488|Primary|Overall Response Rate|To determine the overall response rate of patients who have disease response while on treatment with Cabazitaxel. CT scan will be used to measure tumor pre-treatment and then every 3 cycles (every 63 days)|Pre-treatment and then every 3 cycles or 63 days|||Participants|||Count of Participants
691874|NCT01435031|Secondary|Target Lesion Failure (TLF)|Composite of cardiac death, target vessel-related MI, and clinically-driven TLR. Per protocol.|30 days|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||Participants|||Count of Participants
691570|NCT01437423|Other Pre-specified|Occurrence of Adverse Events by Demographic Characteristic of Participants Following A Single Dose of TETRAXIM™.|The number of participants reporting adverse events by demographic characteristic following a primary series injection of TETRAXIM™ (Combined vaccine of adsorbed diphtheria, tetanus, acellular pertussis and enhanced inactivated poliomyelitis) during the 6 years surveillance period is reported.|Up to 30 days post-primary and booster of vaccination|Adverse events were reported from the Safety Analysis Set.||Participants|||Number
691571|NCT01437423|Other Pre-specified|Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™.|The number of participants reporting unsolicited adverse events within 30 days following a primary series and booster injection of TETRAXIM™ (Combined vaccine of adsorbed diphtheria, tetanus, acellular pertussis and enhanced inactivated poliomyelitis) during the 6 year surveillance period|Up to 30 days post-primary and booster of TETRAXIM™ vaccination|Unsolicited adverse events were reported from the Safety Analysis Set.||Participants|||Number
691572|NCT01437423|Other Pre-specified|Number of Participants Reporting Solicited Adverse Events Following A Primary Series Injection of TETRAXIM™.|Injection-site reactions: Tenderness, Erythema, and Swelling. Systemic reactions: Fever (Temperature) and Crying abnormal. Grade 3 Injection-site reactions: Tenderness, Cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, ≥5 cm. Grade 3 Systemic reactions: Fever, >39.5˚C; Crying abnormal, >3 hours.|Up to 30 days post-primary and booster vaccination|Solicited adverse events were reported from the Safety Analysis Set.||Participants|||Number
691573|NCT01437423|Primary|Number of Participants Reporting Unexpected Adverse Events Up 30 Days Following A Primary Series and Booster Injection of TETRAXIM™.|The number of participants reporting unexpected adverse events within 30 days following a primary series and booster injection of TETRAXIM™ (Combined vaccine of adsorbed diphtheria, tetanus, acellular pertussis and enhanced inactivated poliomyelitis)) during 6 year surveillance period.|Up to 30 days post-primary and booster vaccination|Adverse events were reported from the Safety Analysis Set.||Participants|||Number
691574|NCT01437397|Secondary|Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Total Score|St George’s Respiratory Questionnaire (SGRQ) measures COPD-specific health outcomes and consists of 2 parts with 3 dimension scores (a symptom score and an activity and impacts score). SGRQ total score is the sum of these scores and ranges from 0 (best health status) to 100 (worst health status).|Week 24 of treatment|ITT Population defined as all randomized patients who took at least one administration of study medication and had a baseline and at least one post-baseline FEV1 assessment||Scores on a scale||Standard Error|Least Squares Mean
691575|NCT01437397|Secondary|Change in Transition Dyspnea Index (TDI) Focal Score|"The TDI measures the change from baseline in severity of breathlessness in symptomatic patients. The TDI contains a rating for 3 categories (functional impairment, magnitude of task, magnitude of effort).TDI scale ranges from -3 (major deterioration) to +3 (major improvement) including a 0 score to indicate no change. The 3 categories are added to obtain a focal score ranging from -9 (including 0) to +9."|Week 24 of treatment|ITT Population defined as all randomized patients who took at least one administration of study medication and had a baseline and at least one post-baseline FEV1 assessment||Scores on a scale||Standard Error|Least Squares Mean
691576|NCT01437397|Primary|Change From Baseline in Morning Trough Forced Expiratory Volume in One Second (FEV1)||Week 24 of treatment|ITT Population defined as all randomized patients who took at least one administration of study medication and had a baseline and at least one post-baseline FEV1 assessment||Liters||Standard Error|Least Squares Mean
691577|NCT01437397|Primary|Change From Baseline in 1-hour Morning Post-dose Forced Expiratory Volume in One Second (FEV1)||Week 24 of treatment|ITT Population defined as all randomized patients who took at least one administration of study medication and had a baseline and at least one post-baseline FEV1 assessment||Liters||Standard Error|Least Squares Mean
691578|NCT01437319|Primary|Corneal Infiltrate Event- Phase II|The percentage of Subjects that experienced Corneal Inflammatory Events within their Mucin Ball classification.|12-Month Follow-up|The analysis population consists of subjects that were enrolled into Phase II and were correctly classified as either repeat Mucin Ball former or Non-repeat Mucin Ball former. Twenty- three subjects had incorrect Mucin ball classification.||percentage of subjects|||Number
691579|NCT01437319|Primary|Corneal Infiltrate Events - Phase I|The percentage of Subjects that experienced Corneal Inflammatory Events within their Mucin Ball classification.|1-Month Follow-up|The analysis population consists of subjects that completed all study visits in Phase I without a major protocol deviation and were correctly classified as either repeat Mucin Ball former or Non-repeat Mucin Ball former. Five subjects had incorrect Mucin Ball classification and 8 subjects met study objective.||percentage of subjects|||Number
691580|NCT01437267|Secondary|Number of Participants With Any Solicited Local and Systemic Reaction, After Any Vaccination|Solicited local reactions were: erythema, induration, pain/tenderness. Solicited systemic reactions were; lethargy, irritability, vomiting, diarrhoea, loss of appetite (and persistent crying in the older infants and infants age group)|During the 7-day follow-up period after vaccination|Analysis was done on as treated safety population||participants|||Number
691581|NCT01437267|Primary|Anti-Vi ELISA GMC||At 6 months after last vaccination|Intention-to-treat analysis set||ELISA Units/mL||95% Confidence Interval|Geometric Mean
691582|NCT01437267|Primary|Anti-Vi ELISA Geometric Mean Concentration (GMC)||At 28 days after last vaccination|Intention-to-treat analysis set||ELISA Units/mL||95% Confidence Interval|Geometric Mean
691583|NCT01437267|Primary|Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titer||At 6 months after last vaccination as compared to baseline|Intention-to-treat analysis set||percentage of subjects||95% Confidence Interval|Number
691584|NCT01437267|Primary|Percentage of Subjects With at Least 4-fold Increase in Anti-Vi Enzyme-linked Immunosorbent Assay (ELISA) Titer||At 28 days after last vaccination as compared to baseline|Intention-to-treat analysis set, which included all participants who received the vaccination, those in whom at least one post-vaccination blood sample was collected, and those for whom at least one ELISA result was available.||percentage of subjects||95% Confidence Interval|Number
691585|NCT01437124|Secondary|Chromosomal Abnormality|Deviation of karyotype from normal 2 years post THR|2 years post THR|24 colour FISH||% chromosomal abberations||95% Confidence Interval|Mean
691586|NCT01437124|Primary|Cobalt Chromium Levels|Serum cobalt chromium levels post THR|2 years post THR|metal ion levels||micrograms/dl||95% Confidence Interval|Mean
691587|NCT01437111|Secondary|Mean Percent Change From Baseline of Bone Resorption Marker of Serum Beta-CrossLaps at Week 26|Serum samples for Beta-CrossLaps (β-CTx) will be collected at specific visits during the treatment phase of the study.|Baseline and Week 26|Per Protocol Population consisted of FAS but excluded participants who had important deviations from protocol or did not complete study on study drug. For analysis, participants in Per Protocol Population were categorized into 3 subgroups by osteoporosis therapy received at baseline: Recent/Current, Other therapy, and Treatment Naïve.||Percent change||Standard Deviation|Mean
691588|NCT01437111|Primary|Number of Participants With Serum 25-hydroxyvitamin D >=50 ng/mL at Week 26|Serum samples to measure serum 25-hydroxyvitamin D [25(OH)D] will be collected at specific visits during the treatment phase of the study.|Week 26|Full Analysis Set (FAS) consisted of participants who received >=1 dose of study drug; had >=1 post-baseline observation for the analysis endpoint; and had baseline data. For analysis, participants in the FAS were categorized into 3 subgroups by osteoporosis therapy received at baseline: Recent/Current, Other therapy, and Treatment Naïve||Participants|||Number
691716|NCT01436201|Primary|Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of Digoxin||Predose (Digoxin) and up to 24 hours postdose on Days 7, 10, and 17|Participants who received at least one dose of study drug (digoxin or dulaglutide) with evaluable digoxin Cmax data.||nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
691637|NCT01436799|Primary|Regional Cerebral Oxygen Satuation (rSO2)|definitive values of regional cerebral oxygen saturation(rSO2,%) values are described as mean (SD)|1, 3, 5, 7, and 9 min after the beach chair position|A power analysis was calculated based on a previous study.14 In each group, 16 patients were needed to detect a mean intergroup difference of 5% in the rSO2 value with a power of 80% and a type I error of 0.05. To compensate for a dropout rate of 20%, 40 patients were included in this study.||percentage of rSO2 (%)||Standard Deviation|Mean
691638|NCT01436643|Primary|Number of Participants Who Experienced Adverse Events, Serious Adverse Events and Death|"In this analysis patients with all (serious and non-serious) adverse events, and death were reported.
See Safety Section."|21 weeks|The safety set was used for analysis, which consists of 54 patients, of whom 2 patients did not start treatment with any antidepressant||Participants|||Number
691889|NCT01435031|Secondary|Target Vessel Revascularization (TVR)|Repeat PCI or CABG of the target vessel.|5 years||||||
691639|NCT01436526|Secondary|Half-life Associated With the Terminal Slope (t½)|Half-life refers to the elimination of the drug, i.e. the time it takes for the blood plasma concentration to reach half the concentration in the terminal phase of elimination.|0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administration|N=26 valid for pharmacokinetic analysis||hr||Geometric Coefficient of Variation|Geometric Mean
691640|NCT01436526|Secondary|Time to Reach Maximum Drug Concentration in Plasma After Single Dose (Tmax)|Tmax refers to the time after dosing when a drug attains its highest measurable concentration (Cmax). It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content.|0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administration|N=26 valid for pharmacokinetic analysis||hr||Full Range|Median
691641|NCT01436526|Secondary|Mean Residence Time (MRT)|The mean residence time is the average time that the molecules introduced into the body stay in the body.|0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administration|N=26 valid for pharmacokinetic analysis||hr||Geometric Coefficient of Variation|Geometric Mean
691642|NCT01436526|Secondary|Maximum Observed Drug Concentration in Plasma After Single Dose Administration Divided by Dose Per kg Body Weight (Cmax, Norm)|Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample; Cmax,norm is defined as Cmax divided by dose (mg) per kg body weight.|0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administration|N=26 valid for pharmacokinetic analysis||kg/L||Geometric Coefficient of Variation|Geometric Mean
691643|NCT01436526|Secondary|Area Under the Plasma Concentration Versus Time Curve Divided by Dose Per kg Body Weight (AUCnorm)|The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample; AUCnorm is defined as AUC divided by dose per kg body weight.|0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administration|N=26 valid for pharmacokinetic analysis||kg*hr/L||Geometric Coefficient of Variation|Geometric Mean
691644|NCT01436526|Primary|Maximum Observed Drug Concentration in Plasma After Single Dose Administration (Cmax) Incl. Bioequivalence (BE) Evaluation|Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.|0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administration|N=26 valid for pharmacokinetic analysis||µg/L||Geometric Coefficient of Variation|Geometric Mean
691645|NCT01436526|Primary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to Last Quantifiable Concentration [AUC (0-tn)] Incl. Bioequivalence (BE) Evaluation|The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample; [AUC (0-tn)] is defined as AUC from time 0 to the last data point above the Lower Limit of Quantification.|0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administration|N=26 valid for pharmacokinetic analysis||µg*hr/L||Geometric Coefficient of Variation|Geometric Mean
691646|NCT01436526|Primary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity After Single Dose (AUC) Incl. Bioequivalence (BE) Evaluation|The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample (AUC is defined as area under the concentration vs. time curve from zero to infinity after single (first) dose).|0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administration|N=26 valid for pharmacokinetic analysis||µg*hr/L||Geometric Coefficient of Variation|Geometric Mean
691647|NCT01436500|Secondary|Change in 24-hour Urine Volume|The volume of urine collected in a 24-hour post-treatment period minus the volume collected in a 24-hour pre-treatment period.|Baseline to Hour 96|Data were missing for the post-treatment urine volume measurements in 9 of 42 ifetroban patients and 3 of 13 placebo patients so they were excluded from the analysis.||mL||Standard Deviation|Mean
691648|NCT01436500|Secondary|The Percentage of Patients Achieving a Reduction of Creatinine Clearance to Below Baseline on Two Consecutive Daily Measurements||Day 0 to Day 5|||percentage of participants|||Number
691649|NCT01436500|Secondary|Percentage of Patients Achieving a Treatment-period Serum Creatinine Reduction Below 1.5 mg/dL||Day 0 through Day 5|||percentage of participants|||Number
691650|NCT01436500|Secondary|Safety: Day 28 Mortality||28 days|||percentage of participants|||Number
691651|NCT01436500|Primary|Pharmacokinetic Parameters (Concentration) of Ifetroban and Ifetroban Acylglucuronide After Three Days of Treatment|Plasma concentrations of ifetroban and it's major active metabolite were measured at Baseline and Study Hours 1, 2, 4, 8, 12, 24, 48, 49, 50, 52, 56, 60, and 72 to determine the Pharmacokinetic parameters.|3 days|Patients from which a full series of plasma samples were obtained from baseline through Hour 72 were included in the calculations of the PK parameters. Where the number of participants analyzed in an arm is lower than the number exposed for that arm, the patients with missing data did not contribute to the calculation of the PK parameters.||ng/mL||Standard Deviation|Mean
691652|NCT01436500|Primary|Pharmacokinetic Parameters (Exposure) of Ifetroban and Ifetroban Acylglucuronide After Three Days of Treatment|Plasma concentrations of ifetroban and its primary active metabolite were measured at Baseline and Study Hours 1, 2, 4, 8, 12, 24, 48, 49, 50, 52, 56, 60, and 72 to determine the Pharmacokinetic parameters.|3 days|Patients from which a full series of plasma samples were obtained from baseline through Hour 72 were included in the calculations of the PK parameters. Where the number of participants analyzed in an arm is lower than the number exposed for that arm, the patients with missing data did not contribute to the calculation of the PK parameters.||ng*hr/mL||Standard Deviation|Mean
691890|NCT01435031|Secondary|Target Vessel Revascularization (TVR)|Repeat PCI or CABG of the target vessel.|4 years||||||
691891|NCT01435031|Secondary|Target Vessel Revascularization (TVR)|Repeat PCI or CABG of the target vessel.|3 years||||||
691653|NCT01436500|Primary|Half-life (T-1/2) of Ifetroban and Ifetroban Acylglucuronide|Plasma concentrations of ifetroban and its major active metabolite were measured at Baseline and Study Hours 1, 2, 4, 8, 12, 24, 48, 49, 50, 52, 56, 60, and 72 to determine the Pharmacokinetic parameters.|3 days|Patients from which a full series of plasma samples were obtained from baseline through Hour 72 were included in the calculations of the PK parameters. Where the number of participants analyzed in an arm is lower than the number exposed for that arm, the patients with missing data did not contribute to the calculation of the PK parameters.||hours||Standard Deviation|Mean
691654|NCT01436435|Secondary|Major Adverse Events (MAE)|Number of Major Adverse Events as defined by amputation, death, Target Lesion Revascularization, Target Vessel Revascularization, Myocardial Infarction or angiographic distal embolization that requires a separate intervention or hospitalization through 30 days|30 days|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 22 participants were not evaluable.||Major Adverse Events|||Number
691655|NCT01436435|Secondary|Ankle-Brachial Index (ABI)|Improvement in Ankle-Brachial Index (ABI) by ≥0.10 from the pre-procedure value. ABI is a quick, non-invasive test that compares your blood pressure measured at your ankle with your blood pressure measured at your arm.|12 months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 64 participants were not evaluable.||percentage of patients|||Number
691656|NCT01436435|Secondary|Ankle-Brachial Index (ABI)|Improvement in Ankle-Brachial Index (ABI) by ≥0.10 from the pre-procedure value. ABI is a quick, non-invasive test that compares your blood pressure measured at your ankle with your blood pressure measured at your arm.|6 months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 51 participants were not evaluable.||percentage of patients|||Number
691657|NCT01436435|Secondary|Ankle-Brachial Index (ABI)|Improvement in Ankle-Brachial Index (ABI) by ≥0.10 from the pre-procedure value. ABI is a quick, non-invasive test that compares your blood pressure measured at your ankle with your blood pressure measured at your arm.|30 days|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 22 participants were not evaluable.||percentage of patients|||Number
691658|NCT01436435|Secondary|Procedural Success|Percentage of patients with successful revascularization of target vessel defined as ≤ 30% residual diameter stenosis following atherectomy +/- adjunctive therapy|Index Procedure|Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint||percentage of patients|||Number
691659|NCT01436435|Primary|Binary Restenosis|Percentage of patients with binary restenosis at 12 months as defined by duplex ultrasound derived systolic velocity ratio >2.5. Binary restenosis will be measured by duplex ultrasound technology.|12 months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 184 participants were not evaluable.||percentage of patients|||Number
691660|NCT01436370|Secondary|Number of Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received|Blood was collected from all participants prior to vaccination and at the Days 7, 21 and 180 follow up visits for testing in the HAI assay with 2012-2013 seasonal influenza vaccine strains virus as the assay antigens. A participant met the threshold of seroconversion if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to and Days 7, 21 and 180 following immunization|The analysis population includes all subjects enrolled and vaccinated with the 2012-2013 vaccines who had blood collected at the visit. One RA Participant, Standard Dose and one Healthy Control, High Dose recipient are not included at Day 180 because the participant was out of window and lost to follow-up, respectively.||participants|||Number
691661|NCT01436370|Secondary|Number of Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received|Blood was collected from all participants prior to vaccination and at the Days 7, 21 and 180 follow up visits for testing in the HAI assay with 2011-2012 seasonal influenza vaccine strains virus as the assay antigens. A participant met the threshold of seroconversion if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to and Days 7, 21 and 180 following immunization|The analysis population includes all subjects enrolled and vaccinated with the 2011-2012 vaccines.||participants|||Number
691662|NCT01436370|Secondary|Number of RA Participants With a Worsening Rheumatoid Arthritis Status During the Course of the Study, Based on the RAPID3 Score From the NP2 Questionnaire|The RAPID 3 score is an index of the three patient-reported measures from the Multi-Dimensional Health Assessment Questionnaire (MDHAQ) R808 and serves as an assessment of patient status for those with rheumatoid arthritis. The score consists of the cumulative total of the Function (FN), Pain (PN), and Patient Global (PTGL) values. The severity of the RAPID 3 score is categorized as: >12=High Severity; 6.1-12=Moderate Severity; 3.1-6=Low Severity; and ≤3=Remission. The NP2 questionnaire was completed by RA participants at all clinic visits. Scores at Days 7, 21 and 180 were compared to Day 0 to determine worsening, defined as moving from the baseline category to a more severe category.|Day 0 to Days 7, 21 and 180|All RA participants are included in the analysis population for this outcome measure.||participants|||Number
691663|NCT01436370|Secondary|Number of RA Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received|Blood was collected from RA participants prior to vaccination and at the Days 7 and 180 follow up visits for testing in the HAI assay with 2012-2013 seasonal influenza vaccine strains virus as the assay antigens. A participant met the threshold of seroconversion if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to and Days 7 and 180 following immunization|The analysis population includes RA participants enrolled and vaccinated with the 2012-2013 vaccines who had blood collected at the visit. One RA Participant, Standard Dose recipient is not included at Day 180 because the participant was out of window.||participants|||Number
691664|NCT01436370|Secondary|Number of RA Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received|Blood was collected from RA participants prior to vaccination and at the Days 7 and 180 follow up visits for testing in the HAI assay with 2011-2012 seasonal influenza vaccine strains virus as the assay antigens. A participant met the threshold of seroconversion if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to and Days 7 and 180 following immunization|The analysis population includes all RA subjects enrolled and vaccinated with the 2011-2012 vaccines.||participants|||Number
691665|NCT01436370|Primary|Number of RA Participants in the 2012-2013 Season Who Achieved Seroconversion at Day 21 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received|Blood was collected from RA participants prior to vaccination and at the 21 day follow up visit for testing in the HAI assay with 2012-2013 seasonal influenza vaccine strains virus as the assay antigens. A participant met the threshold of seroconversion if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to and Day 21 following immunization|The analysis population includes all RA participants enrolled and vaccinated with the 2012-2013 vaccines.||participants|||Number
691666|NCT01436370|Secondary|Number of Participants Reporting Solicited Quantitative Local Injection Site Reactions|Participants maintained a memory aid to record daily the occurrence of local reactions of redness and swelling for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Day 0 to Day 7|The analysis population includes all participants enrolled and vaccinated in the study.||participants|||Number
691667|NCT01436370|Secondary|Number of Participants Reporting Solicited Local Injection Site Reactions Based on a Functional Grading Scale|Participants maintained a memory aid to record daily the occurrence of local injection site reactions of pain, tenderness, redness, and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities, with a severity grade of mild meaning no interference, moderate as some interference and severe as significant interference/prevented daily activity. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Day 0 to Day 7|The analysis population includes all participants enrolled and vaccinated in the study.||participants|||Number
691668|NCT01436370|Secondary|Number of Participants Reporting Fever|Participants were provided with a thermometer and a memory aid on which to record daily oral temperatures for 8 days after vaccination (Day 0-7). The protocol defined fever as oral temperature of 38.0 degrees Celsius or higher. Participants are counted as experiencing fever if they reported oral temperatures of 38.0 degrees Celsius or higher on any of the 8 days.|Day 0 to Day 7|The analysis population includes all participants enrolled and vaccinated in the study.||participants|||Number
691669|NCT01436370|Secondary|Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale|Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, nausea, chills, arthralgia, shivering, and asthenia for 8 days after vaccination (Day 0-7) based on their interference with daily activities, with a severity grade of mild meaning no interference, moderate as some interference and severe as significant interference/prevented daily activity. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Day 0 to Day 7|The analysis population includes all participants enrolled and vaccinated in the study.||participants|||Number
691670|NCT01436370|Secondary|Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2012-2013 Season|Blood was collected for HAI assay at Day 0 prior to vaccination and again at 7, 21 and 180 days following vaccination. The HAI assay was conducted with the three antigens in the 2012-2013 seasonal inactivated TIV. Within each 2012-2013 study arm, geometric mean titers and 95% confidence intervals were calculated for each antigen separately.|Days 0, 7, 21 and 180|The analysis population includes all participants enrolled and vaccinated with the 2012-2013 vaccines who had blood collected at the visit. One RA Participant, Standard Dose and one Healthy Control, High Dose recipient are not included at Day 180 because the participant was out of window and lost to follow-up, respectively.||titers||95% Confidence Interval|Geometric Mean
691671|NCT01436370|Secondary|Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2011-2012 Season|Blood was collected for HAI assay at Day 0 prior to vaccination and again at 7, 21 and 180 days following vaccination. The HAI assay was conducted with the three antigens in the 2011-2012 seasonal inactivated TIV. Within each 2011-2012 study arm, geometric mean titers and 95% confidence intervals were calculated for each antigen separately.|Days 0, 7, 21 and 180|||titers||95% Confidence Interval|Geometric Mean
691672|NCT01436370|Secondary|Number of Participants Reporting Vaccine-related Serious Adverse Events (SAEs) Throughout the Course of the Study.|Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof; resulted in a congenital anomaly/birth defect; or may have jeopardized the participant or required intervention to prevent one of these outcomes. Association to vaccination was determined by a study clinician licensed to make medical diagnosis.|Day 0 to Day 180|The analysis population includes all participants enrolled and vaccinated in the study.||participants|||Number
691673|NCT01436370|Primary|Number of RA Participants in the 2011-2012 Season Who Achieved Seroconversion at Day 21 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received|Blood was collected from RA participants prior to vaccination and at the 21 day follow up visit for testing in the HAI assay with 2011-2012 seasonal influenza vaccine strains virus as the assay antigens. A participant met the threshold of seroconversion if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to and Day 21 following immunization|The analysis population includes all RA participants enrolled and vaccinated with the 2011-2012 vaccines.||participants|||Number
697098|NCT01370408|Secondary|Complete Remission During Acute Phase Post-chemotherapy|Proportion of patients achieving an acute CINV CR during the acute phase post -chemotherapy (0-24 hours)|24 hours|||participants|||Number
691674|NCT01436305|Secondary|Count of Participants With Fever > 39 Degrees Celsius and Blood Pressure < 90mm Hg Within 24 Hours of Onset of Transplant Procedure|Temperature of >39 degrees Celsius would be an indication of fever most often in response to an infection or illness. Systolic blood pressure <90mm Hg would be an indication of low blood pressure.|24 hours after transplantation|Intent-to-treat||Participants|||Count of Participants
691675|NCT01436305|Secondary|Count of Participants With EBV Infection as Reported on the Case Report Form as Adverse Events|"Viral infections following renal transplantation is a significant source of recipient morbidity and mortality, and a significant cause of allograft dysfunction and loss. Specific viruses were monitored during this study using participant blood samples.
Acronym: Epstein-Barr virus (EBV)"|Transplantation through last study visit (up to week 156)|Intent-to-treat||Participants|||Count of Participants
691676|NCT01436305|Secondary|Count of Participants With BKV and CMV Viremia (Local Center Monitoring) Reported as Adverse Events|"Viral infections following renal transplantation is significant source of recipient morbidity and mortality, and a significant cause of allograft dysfunction and loss. Specific viruses were monitored during this study using participant blood samples.
Acronyms: BK Polyoma Virus (BKV); Cytomegalovirus (CMV)."|Transplantation through last study visit (up to week 156)|Intent-to-treat||Participants|||Count of Participants
691677|NCT01436305|Secondary|Count of Participants With Infections Requiring Hospitalization or Systemic Therapy Reported as Serious Adverse Events|Infections of certain types (i.e., excluding those identified in the protocol as occurring commonly in this study population) were required to be reported as a serious adverse event if they required either inpatient hospitalization of prolongation of a current hospitalization.|Transplantation through last study visit (up to week 156)|Intent-to-treat||Participants|||Count of Participants
691678|NCT01436305|Secondary|Number of All Adverse Events (AEs) and Serious Adverse Events (SAEs)|Adverse events were collected systematically from enrollment through last study visit. Displayed below are counts of all adverse events per treatment group (including both serious and non-serious adverse events). Separately counts of all adverse events determined to be serious are displayed per treatment group. More detail about adverse events for this trial is displayed in the ‘Adverse Event’ section.|Enrollment through last study visit (up to week 156)|Intent-to-treat||Events|||Number
691679|NCT01436305|Secondary|Count of Participants With Rejection|The number of participants who were treated by their local physician for any type of rejection including, but not limited to cellular rejection and antibody- mediated rejection of the transplanted kidney regardless of the presence of a biopsy.|Transplantation through last study visit (up to week 156)|Intent-to-treat||Participants|||Count of Participants
691680|NCT01436305|Secondary|Number of Events of Death or Graft Loss|This measure counts deaths and graft loss occurring at any point post transplantation. Graft loss is defined as need for dialysis for greater than 30 days duration, allograft nephrectomy, or retransplantation.|Transplantation through last study visit (up to week 156)|Intent-to-treat||Events|||Number
691681|NCT01436305|Secondary|Total Daily Prescribed Pill Number at Days 28 and 84, and Wks 24, 36, 52, 72, 104 and 156|This is a measure of the total number of pills a participant was prescribed on a given day|Day 28, Day 84, Week 24, Week 36, Week 52, Week 72, Week 104, Week 156|Intent-to-treat with available data||Number of pills||Standard Deviation|Mean
691682|NCT01436305|Secondary|Count of Participants With Use of Lipid Lowering Medications at Baseline and Wks 24, 52, 104 and 156|Lipid lowering medications are used in the treatment of high levels of fats (lipids), such as cholesterol in blood|Baseline, Week 24, Week 52, Week 104, Week 156|Intent-to-treat||Participants|||Count of Participants
691683|NCT01436305|Secondary|Fasting Lipid Profile (Total Cholesterol, Non-HDL Cholesterol, LDL, HDL, and Triglyceride) at Baseline and Wks 24, 52, 104 and 156|"A fasting lipid profiles measures total cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride levels. These measurements are used in assessing one’s risk of cardiovascular disease. Target ranges for each of these measures are detailed below.
Total cholesterol: 75-169 mg/dL if age ≤ 20; 100-199 mg/dL if age ≥ 21; high values indicate risk of cardiovascular disease
LDL cholesterol: <70 mg/dL for people with documented cardiovascular disease or metabolic syndrome; <100 mg/dL for people considered high risk for cardiovascular disease; <130 mg/dL for people considered low risk for cardiovascular disease; high values indicate risk of cardiovascular disease
HDL cholesterol: 40mg/dL and higher; high values indicate reduced risk of cardiovascular disease
Non-HDL cholesterol: 30 mg/dL above the target value for LDL cholesterol; high values indicate risk of cardiovascular disease
Triglycerides: <150 mg/dL; high values indicate risk of cardiovascular disease"|Baseline, Week 24, Week 52, Week 104, Week 156|Intent-to-treat||mg/dL||Standard Deviation|Mean
691684|NCT01436305|Secondary|Count of Participants With Use of Anti-hypertensive Medications at Wk 52|Anti-hypertensive medications are a class of drugs that are used to treat hypertension. The medications seek to prevent the complications of high blood pressure, such as stoke and myocardial infarction.|Week 52|Intent-to-treat with available data at Week 52||Participants|||Count of Participants
691685|NCT01436305|Secondary|Standardized Blood Pressure Measurement at Wk 52|A blood pressure measurement consists of two numbers: the systolic and diastolic pressures. Systolic pressure measures the pressure in blood vessels when the heart beats. Diastolic pressure measures the pressure in blood vessels between beats of the heart. Systolic measures of <120 and diastolic measures of <80 are considered normal. Systolic measures of 120-139 and diastolic measures of 80-89 are considered at risk (or pre-hypertension). Systolic measures of ≥140 and diastolic measures of ≥90 are considered high.|Week 52|Intent-to-treat with available data at Week 52||mmHg||Standard Deviation|Mean
691686|NCT01436305|Secondary|HbA1c Measured at Days 28 & 84, and Weeks 24, 36, 52, 72, 104 and 156|Hemoglobin A1c (HbA1c) measures the average blood glucose levels over 8-12 weeks, thus acting as a useful long-term gauge of blood glucose control. A value below 6.0% reflects normal levels, 6.0% to 6.4% reflects prediabetes, and a value of ≥ 6.5% reflects diabetes.|Day 28, Day 84, Week 24, Week 36, Week 52, Week 72, Week 104, Week 156|Intent-to-treat with available data||percent||Standard Deviation|Mean
691687|NCT01436305|Secondary|Count of Participants With Treated Diabetes Between Day 14 and Wk 52|Treated diabetes is defined as the receipt of oral medication or insulin for >14 days between 14 days and 52 weeks post-transplant|Day 14 to Week 52|Intent-to-treat with available data||Participants|||Count of Participants
691892|NCT01435031|Secondary|Target Vessel Revascularization (TVR)|Repeat PCI or CABG of the target vessel.|2 years|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||Participants|||Count of Participants
691688|NCT01436305|Secondary|Count of Participants With Either New Onset Diabetes After Transplant (NODAT) or Impaired Fasting Glucose (IFG) at Wk 52 Based on Criteria Specified by the ADA and WHO|"New onset diabetes is the development of diabetes post-kidney transplant. It was identified by the clinical sites caring for each participant and reported directly in the clinical database. Impaired fasting glucose (IFG) is a determination made by referencing glucose measurements obtained from a standard chemistry panel. Any fasting glucose measure that is between 110 and 125 mg/dL is classified as IFG.
Acronyms: American Diabetes Association (ADA); World Health Organization (WHO)."|Week 52|Intent-to-treat||Participants|||Count of Participants
691689|NCT01436305|Secondary|Count of Participants With de Novo Anti-donor HLA Antibodies at Wk 52|The presence of antibodies reactive to Histocompatibility Antigen (HLA) molecules expressed on the renal allograft have been associated with both acute and chronic injury to the transplanted kidney. The development of de novo anti- donor HLA antibodies may mean a person is more likely to reject the graft.|Week 52|Intent-to-treat||Participants|||Count of Participants
691690|NCT01436305|Secondary|Type of Treatment of Rejection|"Upon having a biopsy performed, persons often receive treatment for rejection based on the results of the biopsy, which may or may not have shown signs of rejection. Details of biopsy findings and corresponding treatment are presented here for each instance of treatment for rejection. Acronyms and abbreviations are defined below.
ACR=Acute Cellular Rejection ATG=Anti-thymocyte globulin therapy Chr. AMR=Chronic Antibody Mediated Rejection Gd.=Grade IFTA=Interstitial Fibrosis and Tubular Atrophy IVIG=Intravenous Immunoglobulin therapy.
Only ‘for cause’ biopsies were performed post-transplant; thus, it is possible for a participant to be included in the analysis population and not have a biopsy for this outcome measure."|Transplantation through last study visit (up to week 156)|Intent-to-treat||Biopsy|Biopsies||Number
691691|NCT01436305|Secondary|Count of Participants With Antibody Mediated Rejection|Antibody mediated rejection (AMR) is defined as diffusely positive staining for C4d, presence of circulating anti-donor antibodies and morphologic evidence of acute tissue injury.|Transplantation through last study visit (up to week 156)|Intent-to-treat||Participants|||Count of Participants
691692|NCT01436305|Secondary|Count of Participants by Severity of First Acute Cellular Rejection by Wk 52|Acute cellular rejection is when lesions at the site of the graft characteristically are infiltrated with large numbers of lymphocytes and macrophages that cause tissue damage. Acute cellular rejection for this endpoint is defined as a grade ≥ IA by Banff 2007 criteria. Severity is graded as IA, IB, IIA, IIB, or III, with IA being the mildest form of cellular rejection and III being the most severe form of cellular rejection. Originally, this endpoint was worded as “The severity of first and highest acute cellular rejection within the first 52 weeks.” But since the highest grade for each subject coincided with the first ACR episode for each subject, only a summary of severity of the first episode is presented here.|Transplantation through Week 52|Intent-to-treat||Participants|||Count of Participants
691693|NCT01436305|Secondary|Count of Participants With Acute Cellular Rejection Grade Equal to or Greater Than IA, by the Banff 2007 Criteria|Acute cellular rejection is when lesions at the site of the graft characteristically are infiltrated with large numbers of lymphocytes and macrophages that cause tissue damage. Acute cellular rejection for this endpoint is defined as a grade ≥ IA by Banff 2007 criteria.|Transplantation through last study visit (up to week 156)|Intent-to-treat||Participants|||Count of Participants
691694|NCT01436305|Secondary|Count of Participants With CAN/IFTA Grade I, II or III at Any Time Post-transplant|CAN/IFTA grades were determined per local pathology interpretations of biopsy tissue. These grades reflect the severity of interstitial fibrosis and tubular atrophy present in the tissue obtained during a kidney biopsy. Higher grades indicate greater severity in interstitial fibrosis and tubular atrophy present the kidney biopsy tissue.|Transplantation through last study visit (up to week 156)|Intent-to-treat||Participants|||Count of Participants
691695|NCT01436305|Secondary|An Increase of One or More Grades of CAN/IFTA When Comparing the Implantation and Subsequent Protocol Biopsies|CAN/IFTA grades reflect the severity of interstitial fibrosis and tubular atrophy present in the tissue obtained during a kidney biopsy. Higher grades indicate greater severity in interstitial fibrosis and tubular atrophy present the kidney biopsy tissue. The aim of this measure was to compare central lab reviewed pre-implantation biopsies to post-transplant biopsies, as pre-specified per protocol; however, the central lab had an inadequate set of biopsies to proceed with evaluation.|Week 52, Week 104, and Week 156|There was an insufficient number of biopsies collected for the summarized data to be reliable.|||||
691696|NCT01436305|Secondary|Count of Participants With Delayed Graft Function Post-Transplant|Delayed graft function is defined as dialysis in the first week on one or more occasions for any indication other than the treatment of acute hyperkalemia in the setting of otherwise acceptable renal function|Any time within the first week post-transplant|Intent-to-treat||Participants|||Count of Participants
691697|NCT01436305|Secondary|The Slope of eGFR by CKD-EPI Over Time Based on Serum Creatinine|The estimated Glomerular Filtration Rate (eGFR) was calculated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI). A score of ≥90 means kidney function is normal. A score between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Scores between 30 and 59 indicates moderately reduced kidney function. Scores between 15 and 29 indicate severely reduced kidney function. Scores below 15 indicate very severe or endstage kidney failure. An estimate of the slope, or change over time, in eGFR was produced using standard statistical linear modeling procedures. The estimate was then re-scaled so that it can be interpreted as a change in eGFR per month. Positive numbers indicate increasing kidney function. Larger numbers indicate greater change in kidney function.|Week 52, Week 104, and Week 156|Intent-to-treat with available data||Change in eGFR (mL/min/1.73m^2) by month||Standard Deviation|Mean
691698|NCT01436305|Secondary|Mean Calculated eGFR Using MDRD 4 Variable Model|The estimated Glomerular Filtration Rate (eGFR) was calculated using the Modification of Diet in Renal Disease equation (MDRD). A score of ≥90 means kidney function is normal. A score between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Scores between 30 and 59 indicates moderately reduced kidney function. Scores between 15 and 29 indicate severely reduced kidney function. Scores below 15 indicate very severe or endstage kidney failure.|Week 52, Week 104, and Week 156|Intent-to-treat population with available data at Weeks 52, 104 and 156||mL/min/1.73m^2||Standard Deviation|Mean
691893|NCT01435031|Secondary|Target Vessel Revascularization (TVR)|Repeat PCI or CABG of the target vessel.|1 year|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||Participants|||Count of Participants
691699|NCT01436305|Secondary|Count of Participants With CKD Stage 4 or 5|"The stages of Chronic Kidney Disease are defined using the participant's GFR value as indicated below.
Stage 1 if GFR value is ≥90; Stage 2 if 60 ≤ GFR < 90; Stage 3A if 45 ≤ GFR < 60; Stage 3B if 30 ≤ GFR < 45; Stage 4 if 15 ≤ GFR < 30; Stage 5 if GFR < 15.
Stage 1 means kidney function is normal. Stage 2 indicates mildly reduced kidney function, pointing to kidney disease. Stages 3A abd 3B indicate moderately reduced kidney function. Stage 4 indicates severely reduced kidney function. Stage 5 indicates very severe or end stage kidney failure."|Week 52, Week 104, and Week 156|Intent-to-treat population with available data at Weeks 52, 104 and 156||Participants|||Count of Participants
691700|NCT01436305|Secondary|Count of Participants by Chronic Kidney Disease (CKD) Stage Post-Transplant|"The stages of Chronic Kidney Disease are defined using the participant's GFR value as indicated below:
Stage 1 if GFR value is ≥90; Stage 2 if GFR value is ≥60 and < 90; Stage 3A if 45 ≤GFR < 60; Stage 3B if 30 ≤ GFR < 45; Stage 4 if 15 ≤GFR < 30;l Stage 5 if GFR < 15.
Stage 1 means kidney function is normal. Stage 2 indicates mildly reduced kidney function, pointing to kidney disease. Stages 3A and 3B indicate moderately reduced kidney function. Stage 4 indicates severely reduced kidney function. Stage 5 indicates very severe or end stage kidney failure."|Week 52, Week 104, and Week 156|Intent-to-treat population with available data at Weeks 52, 104 and 156||Participants|||Count of Participants
691701|NCT01436305|Secondary|Count of Participants With Estimated Glomerular Filtration Rate (GFR) < 60 mL/Min/1.73 m^2 by CKD EPI|GFR was calculated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI). A score of ≥90 means kidney function is normal. A score between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Scores between 30 and 59 indicates moderately reduced kidney function. Scores between 15 and 29 indicate severely reduced kidney function. Scores below 15 indicate very severe or endstage kidney failure. This measure specifically looked at participants with scores less than 60.|Week 52, Week 104, and Week 156|Intent-to-treat population with available data at Weeks 52, 104 and 156.||Participants|||Count of Participants
691702|NCT01436305|Secondary|Count of Participants With Biopsy Proven Acute Rejection at Any Time Post-Transplant|Biopsy proven acute rejection was defined as histologic evidence of borderline or higher cellular rejection per local pathologist.|Transplantation through last study visit (up to week 156)|Intent-to-treat||Participants|||Count of Participants
691703|NCT01436305|Primary|Mean Glomerular Filtration Rate (GFR) Calculated for Each Treatment Group Using the CKD-EPI Equation at Wk 52|GFR was calculated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI). A score of ≥ 90 means kidney function is normal. A score between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Scores between 30 and 59 indicates moderately reduced kidney function. Scores between 15 and 29 indicate severely reduced kidney function. Scores below 15 indicate very severe or endstage kidney failure.|Week 52|Intent-to-treat population with measurable data at Week 52||mL/min/1.73m^2||Standard Deviation|Mean
691704|NCT01436279|Secondary|Difficulty of Procedure|"Outcome measure is the number and percentage of participants where the provider rated the procedure as difficult or very difficult. Provider assessment of difficulty of procedure categories were: very easy, easy, moderate, difficult, or very difficult."|After completion of procedure|||Participants|||Count of Participants
691705|NCT01436279|Secondary|Acceptability to Patient|"Patient was asked whether they would choose to be in the same group again if they had a similar procedure again. The number of participants whose response was yes is being reported."|After procedure completion|||Participants|||Count of Participants
691706|NCT01436279|Secondary|Cervical Dilation Achieved|Cervical dilation at start of procedure|At time of abortion|||mm||Standard Deviation|Mean
691707|NCT01436279|Secondary|Pain Medication (Midazolam) During the Abortion|Amount of pain medication used during the procedure: reported as milligrams of midazolam|Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days.|||mg||Standard Deviation|Mean
691708|NCT01436279|Secondary|Pain Medication (Fentanyl) During the Abortion|Amount of pain medication used during the procedure: reported as micrograms of fentanyl|Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days.|||mcg||Standard Deviation|Mean
691709|NCT01436279|Secondary|Subject Discomfort Before the Abortion|Pain was subjectively described by the subjects as : None, Mild, Moderate, Severe|Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days.|||participants|||Number
691710|NCT01436279|Secondary|Operative Time|Interval from initiation of vacuum aspiration to speculum removal|Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days.|||minutes||95% Confidence Interval|Median
691711|NCT01436279|Primary|Length of Procedure|Interval from speculum insertion to speculum removal|Subjects will be followed from the administration of mifepristone/misoprostol or laminaria, until the end of their procedure, a total of two days.|||minutes||95% Confidence Interval|Mean
691712|NCT01436266|Primary|Blood Loss|500 cc or more|one day following the procedure|||Participants|||Count of Participants
691713|NCT01436253|Primary|Percentage of Participants With Reduced Cardiovascular Risk|Cardiovascular risk assessment to determine the 10-year risk for developing cardiovascular disease was done using Framingham risk scoring; categories scored are age, high density lipoprotein (HDL) cholesterol value, total cholesterol value, history of cigarette smoking, and systolic blood pressure. The total of all the points for each risk factor is used to assign a percentage of risk for the occurence of cardiovascular disease within 10 years. Total points for men range from -9 to +37 and for women from -8 to +46; >=17 total points for men, and >=25 total points for women indicates a >=30% risk of developing cardiovascular disease.|Baseline and Month 3|Participants meeting all inclusion and exclusion criteria.||Percentage of participants|||Number
691714|NCT01436253|Primary|Percentage of Participants Achieving Target Lipid Values|Target total cholesterol value was <4.5 mmol/L and target low densisty lipoprotein (LDL) value was <2.5 mmol/L|Baseline and Month 3|Participants meeting all inclusion and exclusion criteria.||Percentage of participants||95% Confidence Interval|Number
691715|NCT01436201|Primary|Pharmacokinetics: Time of Maximum Observed Drug Concentration (Tmax) of Digoxin||Predose (Digoxin) and up to 24 hours postdose on Days 7, 10, and 17|Participants who received at least one dose of study drug (digoxin or dulaglutide) with evaluable digoxin Tmax data.||hours||Full Range|Median
691717|NCT01436201|Primary|Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of Digoxin||Predose (Digoxin) and up to 24 hours postdose on Days 7, 10, and 17|Participants who received at least one dose of study drug (digoxin or dulaglutide) with evaluable digoxin AUC data.||nanograms times hours/milliliter||Geometric Coefficient of Variation|Geometric Mean
691718|NCT01436175|Secondary|PRUQ-MDD – Effect of Depressive Symptoms|The PRUQ-MDD assessed the long term economic outcomes. It collects utilization of healthcare resources reported by the study participants. Participants answered following questions on a 0 to 10 point scale – 1. During past week, how much did depressive symptoms affect work productivity; 2. During past week, how much did depressive symptoms affect regular non-work daily activities. Higher scores indicates more effect of depressive symptoms on work productivity and non-work daily activities.|Week 52/ET|FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure, n = participants evaluable for specified categories||units on scale||Standard Deviation|Mean
691719|NCT01436175|Secondary|PRUQ-MDD – Number of Hours|The PRUQ-MDD assessed the long term economic outcomes. It collects utilization of healthcare resources reported by the study participants. Participants answered following questions - 1. How many hours do you usually work or would you usually be expected to work (hrs/week); 2. How many hours did you actually work last week; 3. On average, how many hours do you volunteer per week. Number of hours are reported.|Week 52/ET|FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure.||hours||Standard Deviation|Mean
691720|NCT01436175|Secondary|PRUQ-MDD – Number of Events (Visit to Health Care Provider/Visit to Hospital Facilities/Number of Times a Test Was Performed)|The PRUQ-MDD assessed the long term economic outcomes. It collects utilization of healthcare resources reported by the study participants. Participants answered following questions – 1. How many times did you visit the following healthcare providers in the past month: Family doctor/primary care, Non-physician healthcare practitioner (NPHP), Psychiatrist/Psychologist/Counselor (PPC); 2. How many times did you take one of the tests, mentioned below, during the past month: Blood test, CT Scan, X Ray, Renal function, Thyroid function; and 3. How many times did you visit the hospital emergency room (ER), urgent care facility (UCF) or an after-hours clinic (AHC) in the past month. Number of events (visit to health care provider, visit to hospital facilities, and number of times a test was performed) are reported.|Week 52/ET|FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure, n = participants evaluable for specified categories||events||Standard Deviation|Mean
691721|NCT01436175|Secondary|PRUQ-MDD – Number of Days of Resource Utilization|The PRUQ-MDD assessed the long term economic outcomes. It collects utilization of healthcare resources reported by the study participants. Number of nights in medical/surgical ward, number of nights in ICU, and number of days a participant received home care in the past month are reported.|Week 52/ET|FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure, n = participants evaluable for specified categories.||days||Standard Deviation|Mean
691722|NCT01436175|Secondary|Patient Resource Utilization Questionnaire - Major Depressive Disorder (PRUQ-MDD)|"The PRUQ-MDD assessed the long term economic outcomes. It collects utilization of healthcare resources reported by the study participants. Participants answered the following questions:
1. Were you hospitalized in the past month, 2. Do you work for pay, 3. If you missed time at work last week, please note all the reasons why, 4. Would you say that the past week was typical, like the rest of the 3 weeks this month, in terms of your working hours, 5. Do you do volunteer work (VW), and 6. If you do not receive money for your work and do not participate in volunteer work, the reason is.
Number of participants with response is reported."|Week 52/ET|FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure||participants|||Number
691723|NCT01436175|Secondary|Amphetamine Cessation Symptom Assessment (ACSA) Total Score|ACSA scale has 16 symptom items rated on a scale from 0 (not at all) to 4 (extremely) with a possible total score range of 0 to 64. Higher scores indicate greater withdrawal symptom severity.|Week 53|FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure.||units on a scale||Standard Deviation|Mean
691724|NCT01436175|Secondary|Change From Baseline in Sexual Functioning Questionnaire - 14 Item Scale (CSFQ-14) Total Score at Week 52/ET|CSFQ-14 is a 14 item self-report tool that evaluates sexual functioning. Each item is scored on a 5-point Likert scale ranging from 1 (never) to 5 (always) with total scores ranging from 14 to 70. Higher scores reflect better sexual functioning. Baseline was defined as the Augmentation Baseline Visit of the antecedent study (SPD489-209 [NCT01435759], SPD489-322 [NCT01436149], and SPD489-323 [NCT01436162]).|Baseline, Week 52/ET|FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure, n = participants evaluable for specified categories.||units on a scale||Standard Deviation|Mean
691725|NCT01436175|Secondary|Quality of Life Enjoyment Satisfaction Questionnaire Short Form (Q-LES-Q-SF)|The Q-LES-Q-SF is a 16-item self-report questionnaire which evaluates general participant satisfaction with health, mood, relationships, functioning in daily life, and their treatment. Each item is rated on a 5-point scale from 1 (very poor) to 5 (very good). The total raw score (summary scale score) was calculated by summing item scores 1 to 14 (total raw score range: 14 to 70). Item 15 (satisfaction with medication, raw score range: 1 to 5) and Item 16 (overall satisfaction and contentment; raw score range: 1 to 5) were stand-alone items. For reporting, summary scale, Item 15 and Item 16 raw scores were transformed into percentage maximum possible score which ranged from 0 to 100, where higher scores are indicative of greater enjoyment or satisfaction.|Week 52/ET|FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure, n = participants evaluable for specified categories||units on a scale||Standard Deviation|Mean
691726|NCT01436175|Secondary|Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)|QIDS-SR is a validated, self-reported rating scale that contains 16 items scored on a scale from 0-3 with total scores ranging from 0 (no depression) to 27 (very severe depression). Lower scores indicate less depression. The QIDS-SR was only assessed in the SPD489-322 antecedent study. The QIDS-SR total score is calculated as the sum of the highest score on any 1 of Items 1-4, Item 5, the highest score on any 1 of Items 6-9, Items 10-14, the highest score on either Item 15 or 16.|Week 52/ET|FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure||units on a scale||Standard Deviation|Mean
691894|NCT01435031|Secondary|Target Vessel Revascularization (TVR)|Repeat PCI or CABG of the target vessel.|6 months|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||Participants|||Count of Participants
691727|NCT01436175|Secondary|EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Visual Analog Scale|EQ-5D-5L is one of the most widely used generic index measures of health-related quality of life. EQ-5D-5L Visual Analog Scale score is numbered from 0 to 100, where a score of 100 is the best health a participant can imagine|Week 52/ET|FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure.||units on a scale||Standard Deviation|Mean
691728|NCT01436175|Secondary|EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Anxiety/Depression|Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses|Week 52/ET|FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure.||participants|||Number
691729|NCT01436175|Secondary|EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Pain/Discomfort|Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses|Week 52/ET|FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure.||participants|||Number
691730|NCT01436175|Secondary|EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Usual Activities|Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses|Week 52/ET|FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure.||participants|||Number
691731|NCT01436175|Secondary|EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Self-Care|Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses|Week 52/ET|FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure.||participants|||Number
691732|NCT01436175|Secondary|EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Mobility|Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses|Week 52/ET|FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure.||participants|||Number
691733|NCT01436175|Secondary|Short Form-12 Health Survey Version 2 (SF-12V2)|SF-12V2 is a multi-purpose, 7-item survey that measures 8 domains of health: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. It is expressed by two summary measures (Aggregate Physical and Aggregate Mental) for which values can range from 0 to 100. A higher score is indicative of a better health state.|Week 52/ET|FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure.||units on a scale||Standard Deviation|Mean
691734|NCT01436175|Secondary|Number of Participants With Improvement on Clinical Global Impressions - Global Improvement (CGI-I)|Participants who did not have Clinical Global Impressions – Severity of Illness (CGI-S) assessed at Week 8 in the antecedent study should not have had CGI-I assessed in this study and were excluded from the summary of CGI-I. CGI-I consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement includes a score of 1 (very much improved) or 2 (much improved) on the scale.|Week 52/ET|FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure.||participants|||Number
691735|NCT01436175|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 52/ET|"Designed to evaluate the extent to which illness symptoms impact a participant's life in 3 areas: work, social, and family/home. Each area is scored on a scale from 0 (no impairment) to 10 (highly impaired) with a total score ranging from 0 (unimpaired) to 30 (highly impaired). Lower scores translate into less impairment.
Baseline was defined as the Augmentation Baseline Visit of the antecedent study (SPD489-209 [NCT01435759], SPD489-322 [NCT01436149], and SPD489-323 [NCT01436162])."|Baseline, Week 52/ET|Full Analysis Set (FAS) included all participants in the Safety Analysis Set who had at least 1 clinical experience outcome assessment in the study. Here n = participants evaluable at specified time-points.||units on a scale||Standard Deviation|Mean
691736|NCT01436175|Primary|Change From Baseline in Pulse Rate at Week 52|Baseline was defined as the Augmentation Baseline Visit of the antecedent study (SPD489-209 [NCT01435759], SPD489-322 [NCT01436149], and SPD489-323 [NCT01436162]).|Baseline, Week 52/ET|Safety Analysis Set. Here n = participants evaluable at specified time-points.||beats per minute(bpm)||Standard Deviation|Mean
691737|NCT01436175|Primary|Change From Baseline in Diastolic Blood Pressure at Week 52|Baseline was defined as the Augmentation Baseline Visit of the antecedent study (SPD489-209 [NCT01435759], SPD489-322 [NCT01436149], and SPD489-323 [NCT01436162]).|Baseline, Week 52/ET|Safety Analysis Set. Here n = participants evaluable at specified time-points.||mmHg||Standard Deviation|Mean
691738|NCT01436175|Primary|Change From Baseline in Systolic Blood Pressure at Week 52|Baseline was defined as the Augmentation Baseline Visit of the antecedent study (SPD489-209 [NCT01435759], SPD489-322 [NCT01436149], and SPD489-323 [NCT01436162]).|Baseline, Week 52/ET|Safety Analysis Set. Here n = participants evaluable at specified time-points.||millimeter of mercury(mmHg)||Standard Deviation|Mean
691750|NCT01436162|Secondary|Percentage of Participants Achieving a 50% Response on the MADRS|The percentage of subjects who achieved a 50% response (i.e. ≥50% reduction in MADRS total score from the Lead-in Baseline, Visit 2).|Up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).||percentage of participants|||Number
691739|NCT01436175|Primary|Columbia-Suicide Severity Rating Scale (C-SSRS)|C-SSRS is a semi-structured interview that captures the occurrence, severity, and frequency of suicide-related thoughts and behaviour during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale.|Week 5 up to Week 52/Early Termination(ET)|Safety analysis set included all participants who took at least 1 dose of investigational product and had at least 1 post-Visit 0 (Week 0) safety assessment in this study||participants|||Number
691740|NCT01436162|Secondary|Amphetamine Cessation Symptom Assessment (ACSA) - Total Aggregate Score|ACSA scale has 16 symptom items rated on a scale from 0 (not at all) to 4 (extremely) with a possible total score range of 0 to 64. Higher scores indicate greater withdrawal symptom severity.|8 weeks|Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 safety assessment (e.g., coming back for any visit, reporting of an AE, or reporting the absence of AEs) after the Augmentation Baseline Visit (Visit 8).||Score||Standard Deviation|Mean
691741|NCT01436162|Secondary|Columbia Suicide Severity Rating Scale (C-SSRS)|C-SSRS is a semi-structured interview that captures the occurence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale.|Up to 8 weeks|Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 safety assessment (e.g., coming back for any visit, reporting of an adverse event [AE], or reporting the absence of AEs) after the Augmentation Baseline Visit (Visit 8).||percentage of participants|||Number
691742|NCT01436162|Secondary|Mean Change From Baseline in the Multidimensional Assessment of Fatigue (MAF) Global Fatigue Index (GFI)|MAF contains 16 items scored on a scale from 1 (not at all) to 10 (a great deal). Answers are converted to a Global Fatigue Index with total scores ranging from 1 (no fatigue) to 50 (severe fatigue). Lower scores indicate less fatigue.|Up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).||units on a scale||Standard Error|Least Squares Mean
691743|NCT01436162|Secondary|Clinical Global Impressions - Global Improvement (CGI-I)|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|Up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).||percentage of participants|||Number
691744|NCT01436162|Secondary|Mean Change in Sexual Functioning Questionnaire - 14 Item Scale (CSFQ-14) Total Score Female|The CSFQ-14 is a short-form interview/questionnaire that measures illness- and medication-related changes in sexual functioning. A 5-point Likert scale is used ranging from 1 (never) to 5 (always). The CSFQ-14 total score can range from 14 to 70, with lower scores being associated with worsened sexual functioning.|Up to 8 weeks|Full Analysis Set: Female subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).||units on a scale||Standard Deviation|Mean
691745|NCT01436162|Secondary|Mean Change in Sexual Functioning Questionnaire - 14 Item Scale (CSFQ-14) Total Score Male|The CSFQ-14 is a short-form interview/questionnaire that measures illness- and medication-related changes in sexual functioning. A 5-point Likert scale is used ranging from 1 (never) to 5 (always). The CSFQ-14 total score can range from 14 to 70, with lower scores being associated with worsened sexual functioning.|Up to 8 weeks|Full Analysis Set: Male subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).||units on a scale||Standard Deviation|Mean
691746|NCT01436162|Secondary|Mean Change From Baseline in the Short Form-12 Health Survey V2 (SF-12V2)|Total score ranges from 0 (lowest level of health) - 100 (highest level of health) on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability (i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability). Higher scores are associated with better quality of life.|Up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).||units on a scale||95% Confidence Interval|Least Squares Mean
691747|NCT01436162|Secondary|Mean Change From Baseline in Abbreviated Brief Assessment of Cognition Affective Disorders (ABAC-A) Composite T-Scores|The ABAC-A is a rater-administered series of activities designed to be sensitive to the critical cognitive deficits in affective disorders and schizophrenia. There are 6 subtests of the ABAC-A: List Learning (verbal memory); Digit Sequencing Task (working memory); Token Motor Task (motor speed); Verbal Fluency; Symbol Coding (attention and processing speed); and Tower of London Test (executive functions). The ABAC-A Composite T-score change from Augmentation Baseline Visit (Visit 8; Week 8) at Visit 14/Early Termination (ET) (Week 16/ET) was analyzed.|up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).||t-score||95% Confidence Interval|Least Squares Mean
691748|NCT01436162|Secondary|Mean Change From Baseline Over Time in MADRS Total Score|MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression.|Up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of MADRS total score after the Augmentation Baseline Visit (Visit 8). Sample size (n) of MADRS total score at each visit differed from sample size (N) of the FAS.||units on a scale||95% Confidence Interval|Least Squares Mean
691749|NCT01436162|Secondary|Percent of Participants Achieving Remission on the MADRS|MADRS remission was defined as a MADRS total score of ≤10.|Up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).||percentage of participants|||Number
691751|NCT01436162|Secondary|Percentage of Participants Achieving a 25% Response on the MADRS|The percentage of subjects who achieved a 25% response (i.e. ≥25% reduction in MADRS total score from the Lead-in Baseline, Visit 2).|Up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).||percentage of participants|||Number
691752|NCT01436162|Secondary|Mean Change From Baseline in Sheehan Disability Scale (SDS) Total Score at 8 Weeks|Designed to evaluate the extent to which illness symptoms impact a subject's life in 3 areas: work/school, social, and family/home. Each area is scored on a scale from 0 (no impairment) to 10 (highly impaired) with a total score ranging from 0 (unimpaired) to 30 (highly impaired). Lower scores translate into less impairment.|8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).||units on a scale||95% Confidence Interval|Least Squares Mean
691753|NCT01436162|Primary|Mean Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at 8 Weeks|MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression.|8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).||units on a scale||95% Confidence Interval|Least Squares Mean
691754|NCT01436149|Secondary|Amphetamine Cessation Symptom Assessment (ACSA)|ACSA scale has 16 symptom items rated on a scale from 0 (not at all) to 4 (extremely) with a possible total score range of 0 to 64. Higher scores indicate greater withdrawal symptom severity.|up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).||units on a scale||Standard Deviation|Mean
691755|NCT01436149|Secondary|Columbia Suicide Severity Rating Scale (C-SSRS)|C-SSRS is a semi-structured interview that captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behavior occurred. The assessment is done by the nature of the responses, not by a numbered scale.|up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).||percentage of participants|||Number
691756|NCT01436149|Secondary|Clinical Global Impressions - Global Improvement (CGI-I)|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).||percentage of participants|||Number
691757|NCT01436149|Secondary|Mean Change From Baseline in the Quality of Life Enjoyment Satisfaction Questionnaire Short Form (Q-LES-Q-SF)|The short form is a 16-item self-report questionnaire which evaluates general subject satisfaction with health, mood, relationships, functioning in daily life, and the treatment being taken. Overall level of satisfaction is evaluated on a 5-point scale from 1 (very poor) to 5 (very good). The total score ranges from 14-70 (last two items on the form are not included in the total score). A higher score indicates a better quality of life.|up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).||units on a scale||95% Confidence Interval|Least Squares Mean
691758|NCT01436149|Secondary|Mean Change From Baseline in the Short Form-12 Health Survey V2 (SF-12V2)|Total score ranges from 0 (lowest level of health) - 100 (highest level of health) on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability (i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability). Higher scores are associated with better quality of life.|up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).||units on a scale||95% Confidence Interval|Least Squares Mean
691759|NCT01436149|Secondary|Mean Change From Baseline in the Quick Inventory of Depressive Symptomatology - Self Report (QIDS SR)|The QIDS-SR is a self-administered questionnaire designed to rate depressive symptoms. The scale contains 16 items, each scored using a 4-point scale ranging from 0 (representing the most favorable response [low amount of symptom]) to 3 (representing the least favorable response [frequent/intense symptom]). The total score could range from 0 (no depression) to 27 (very severe depression). Higher scores represent more severe depressive symptoms.|up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).||units on a scale||95% Confidence Interval|Least Squares Mean
691760|NCT01436149|Secondary|Mean Change From Baseline Over Time in MADRS Total Score|MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression.|Baseline and up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).||units on a scale||95% Confidence Interval|Least Squares Mean
691761|NCT01436149|Secondary|Percentage of Participants Achieving Remission on the MADRS|MADRS remission was defined as a MADRS total score of ≤10. A comparison was performed at Visit 14/ET (Week 16/ET).|up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).||percentage of participants|||Number
691895|NCT01435031|Secondary|Target Vessel Revascularization (TVR)|Repeat PCI or CABG of the target vessel.|30 days|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||Participants|||Count of Participants
691762|NCT01436149|Secondary|Percentage of Participants Achieving a 50% Response on the MADRS|The percentage of subjects who achieved a 50% response (i.e., ≥50% reduction in MADRS total score from Lead-in Baseline, Visit 2; Week 0). A comparison was performed at Visit 14/ET (Week 16/ET).|up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).||percentage of participants|||Number
691763|NCT01436149|Secondary|Percentage of Participants Achieving a 25% Response on the MADRS|The percentage of subjects who achieved a 25% response (i.e., ≥25% reduction in MADRS total score from Lead-in Baseline, Visit 2; Week 0). A comparison was performed at Visit 14/Early Termination (ET) (Week 16/ET).|up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).||percentage of participants|||Number
691764|NCT01436149|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score at up to 8 Weeks|Designed to evaluate the extent to which illness symptoms impact a subject's life in 3 areas: work/school, social, and family/home. Each area is scored on a scale from 0 (no impairment) to 10 (highly impaired) with a total score ranging from 0 (unimpaired) to 30 (highly impaired). Lower scores translate into less impairment.|8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).||units on a scale||95% Confidence Interval|Least Squares Mean
691765|NCT01436149|Primary|Mean Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at up to 8 Weeks|MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression.|8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).||units on a scale||95% Confidence Interval|Least Squares Mean
691766|NCT01436110|Secondary|Number of Participants Who Withdrew Due to Lack of Efficacy During the 24-week Treatment Period|The reason for withdrawal was lack of efficacy if a participant was withdrawn due to: clinic FEV1 falling below the FEV1 stability limit; participant experiencing at least 4 days of AM or PM PEF falling below the PEF stability limit and/or at least 3 days of >=12 inhalations/day of albuterol/salbutamol usage during the 7 days immediately preceding any contact; or the occurrence of an asthma exacerbation, defined as the deterioration of asthma requiring the use of systemic (oral, parenteral, or depot) corticosteroids for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. The FEV1 stability limit was calculated as the best pre-salbutamol/albuterol FEV1 at Visit 2 * 80%. The PEF stability limit was calculated as the mean AM PEF from the available 7 consecutive days preceding Visit 2 * 80%.|From the first dose of the study medication until Week 24/Early Withdrawal|ITT Population||Participants|||Number
691767|NCT01436110|Secondary|Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 24-week Treatment Period|Asthma symptoms were recorded in a daily eDairy by the participants every day in the morning and evening before taking any rescue or study medication and before the peak expiratory flow measurement. A 24-hour period in which a participant’s responses to both the morning and evening assessments indicated no symptoms was considered to be symptom free. A 24-hour period was considered as missing if both the day time and night time data were missing or if one was symptom-free but the other was missing. The Baseline value was the average of the values of the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|From Baseline up to Week 24|ITT Population. Only those participants available at the specified time points were analyzed.||Percentage of symptom-free 24-hr periods||Standard Error|Least Squares Mean
691768|NCT01436110|Secondary|Change From Baseline in Daily Morning (AM) PEF Averaged Over the 24-week Treatment Period|PEF is a measure of lung function and is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning and evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline (defined as the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily AM PEF over the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|From Baseline up to Week 24|ITT Population. Only those participants available at the specified time points were analyzed.||L/min||Standard Error|Least Squares Mean
691769|NCT01436110|Secondary|Change From Baseline in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 24-week Treatment Period|PEF is a measure of lung function and is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning and evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline (defined as the average of the values of the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily trough PM PEF over the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|From Baseline up to Week 24|ITT Population. Only those participants available at the specified time points were analyzed.||Liters/minute (L/min)||Standard Error|Least Squares Mean
691791|NCT01435928|Other Pre-specified|EuroQol (EQ-5D): EQ-VAS Score|"The EQ-5D is a self-administered, standardized measure of health states consisting of two parts: EQ-5D descriptive system consisting of one question in each of five dimensions (mobility, self-care, pain, usual activities, and anxiety) with three possible response levels per question, classifying patients into one of 243 distinct health states, and a 20-cm visual analogue health status rating.
The 20-cm visual analog scale (VAS) has endpoints labeled best imaginable health state and worst imaginable health state that are anchored at 100 and 0, respectively. Respondents are asked to indicate how they rate their own health by drawing a line from an anchor box to that point on the EQ-VAS, which best represents their own health on that day."|Double-blind phase - 28 Weeks|There were 5 Lurasidone subjects and 3 placebo subjects that had no post-baseline assessment.||units on a scale||Standard Deviation|Mean
691770|NCT01436110|Secondary|Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods Over the 24-week Treatment Period|The number of inhalations of rescue bronchodilator, albuterol/salbutamol inhalation aerosol, used during the day and night was recorded by the participants in a daily electronic diary (eDiary). A 24-hour period in which a participant’s responses to both the morning and evening assessments indicated no use of rescue medication was considered to be rescue free. A 24-hour period was considered as missing if both day time and night time values were missing or if one of the day time or night time values were missing and the other value indicated no use of rescue medication. The Baseline value is the average of the values over the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|From Baseline up to Week 24|ITT Population. Only those participants available at the specified time points were analyzed.||Percentage of rescue-free 24-hr periods||Standard Error|Least Squares Mean
691771|NCT01436110|Primary|Change From Baseline in Clinic Visit Evening (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 24-week Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Evening clinic visit FEV1 is defined as the clinic visit (pre-bronchodilator and pre-dose) FEV1 measurement taken at the Week 24 clinic visit. Pre-dose and pre-rescue albuterol/salbutamol trough FEV1 were measured electronically by spirometry in the evening at the Baseline through Week 24 clinic visits. The highest of 3 technically acceptable measurements was recorded. Baseline was the pre-dose value obtained at Visit 2. Change from Baseline was calculated as the Week 24 value minus the Baseline value. Analysis was performed using analysis of covariance (ANCOVA) with covariates of Baseline, region, sex, age, and treatment. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing, pre-dose, post-Baseline, on-treatment measurement at scheduled clinic visits was used to impute the missing measurements.|Baseline and Week 24|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study medication. Only those participants with non-missing covariates and post-Baseline FEV1 data were analyzed.||Liters||Standard Error|Least Squares Mean
691772|NCT01436084|Primary|Number of Participants With Overall Response|Overall response based on hematologic improvement defined by International Working Group (IWG) response criteria in myelodysplasia. Complete remission (CR): Bone marrow of 5% myeloblasts with normal maturation of all cell lines, noted persistent dysplasia; Partial Remission: CR criteria if abnormal before treatment except Bone marrow blasts decreased by 50% over pretreatment but still > 5%; Marrow CR: Bone marrow 5% myeloblasts and decrease by 50% over pretreatment. Bone marrow aspirate pre-therapy (Day 0) and on Day 28 of first cycle then every 3 cycles. Responses must last at least 4 weeks.|28 days to one year|Study was halted prior to completion of treatment and assessment for any participant(s).|||||
691773|NCT01436071|Secondary|Number of Participants Who Withdrew Due to a Lack of Efficacy During the 12-week Treatment Period|The reason for withdrawal was lack of efficacy if a participant was withdrawn due to: clinic FEV1 falling below the FEV1 stability limit; participant experiencing at least 4 days of AM or PM PEF falling below the PEF stability limit and/or at least 3 days of >=12 inhalations/day of albuterol/salbutamol usage during the 7 days immediately preceding any contact; or the occurrence of an asthma exacerbation, defined as the deterioration of asthma requiring the use of systemic (oral, parenteral, or depot) corticosteroids for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. The FEV1 stability limit was calculated as the best pre-salbutamol/albuterol FEV1 at Visit 2 * 80%. The PEF stability limit was calculated as the mean AM PEF from the available 7 consecutive days preceding Visit 2 * 80%.|From the first dose of the study medication until Week 12/Early Withdrawal|ITT Population||Participants|||Number
691774|NCT01436071|Secondary|Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods Over the 12-week Treatment Period|Asthma symptoms were recorded in a daily eDairy by the participants every day in the morning and evening before taking any rescue or study medication and before the peak expiratory flow measurement. A 24-hour period in which a participant’s responses to both the morning and evening assessments indicated no symptoms was considered to be symptom free. A 24-hour period was considered as missing if both the day time and night time data were missing or if one was symptom-free but the other was missing. The Baseline value was the average of the values of the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 12-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|From Baseline up to Week 12|ITT Population. Only those participants available at the specified time points were analyzed.||Percentage of symptom-free 24-hr periods||Standard Error|Least Squares Mean
691775|NCT01436071|Secondary|Change From Baseline in Daily Morning (AM) PEF Averaged Over the 12-week Treatment Period|PEF is a measure of lung function and is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning and evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline (defined as the average of the values of the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily AM PEF over the 12-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|From Baseline up to Week 12|ITT Population. Only those participants available at the specified time points were analyzed.||L/min||Standard Error|Least Squares Mean
691776|NCT01436071|Secondary|Change From Baseline in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 12-week Treatment Period|PEF is a measure of lung function and is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning and evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline (defined as the average of the values of the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily trough PM PEF over the 12-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|From Baseline up to Week 12|ITT Population. Only those participants available at the specified time points were analyzed.||Liters/minute (L/min)||Standard Error|Least Squares Mean
691777|NCT01436071|Secondary|Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods Over the 12-week Treatment Period|The number of inhalations of rescue bronchodilator, albuterol/salbutamol inhalation aerosol, used during the day and night was recorded by the participants in a daily electronic diary (eDiary). A 24-hour period in which a participant’s responses to both the morning and evening assessments indicated no use of rescue medication was considered to be rescue free. A 24-hour period was considered as missing if both day time and night time values were missing or if one of the day time or night time values were missing and the other value indicated no use of rescue medication. The Baseline value is the average of the values over the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|From Baseline up to Week 12|ITT Population. Only those participants available at the specified time points were analyzed.||Percentage of rescue-free 24-hr periods||Standard Error|Least Squares Mean
691778|NCT01436071|Primary|Change From Baseline in Clinic Visit Evening (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 12-week Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Evening clinic visit FEV1 is defined as the clinic visit (pre-bronchodilator and pre-dose) FEV1 measurement taken at the Week 12 clinic visit. Pre-dose and pre-rescue albuterol/salbutamol trough FEV1 were measured electronically by spirometry in the evening at the Baseline through Week 12 clinic visits. The highest of 3 technically acceptable measurements was recorded. Baseline was the pre-dose value obtained at Visit 2. Change from Baseline was calculated as the Week 12 value minus the Baseline value. Analysis was performed using analysis of covariance (ANCOVA) with covariates of Baseline, region, sex, age, and treatment. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing, pre-dose, post-Baseline on-treatment measurement at scheduled clinic visits was used to impute the missing value.|Baseline and Week 12|Intent-to-Treat (ITT) Population: all participants (par.) randomized to treatment who received >=1 dose of study medication, except for the par. of one investigator (excluded after good clinical practice [GCP] issues identified during a site audit). Only those par. with non-missing covariates and a post-Baseline FEV1 measurement were analyzed.||Liters||Standard Error|Least Squares Mean
691779|NCT01436045|Primary|Trails B - Errors|The results are presented as the mean sum of the errors during the Trails B assessment For each of these, a higher number of errors is indicative of a higher cognitive deficit.|20 minutes post-intranasal administration|||mean number of errors||Standard Error|Mean
691780|NCT01436045|Primary|Trails B - Seconds|The results are presented as the number of seconds to complete Trails B. For each of these, a higher number of seconds is indicative of a higher cognitive deficit.|20 minutes post-intranasal administration|||mean seconds||Standard Error|Mean
691781|NCT01436045|Secondary|Olfactory Function|"The Sniff Magnitude Test (SMT) measures olfactory function not influenced by cognitive problems (minimal dependence on language, cognitive ability, memory, and odor naming ability). Sniff magnitude ratios are calculated as a ratio of sniff magnitudes (area under the sniff curve). Lower sniff magnitude ratios indicate more impairment.
[average sniff magnitude of malodor/average sniff magnitude to a null odor]"|60 minute post intranasal administration|||ratio of area under the sniff curve||Standard Error|Mean
691782|NCT01436045|Primary|Cognitive Performance|"The results are presented as a mean number of correct responses for each cognitive assessment.
For each of these, a lower number correct is indicative of a higher cognitive deficit.
Ranges are as follows: RBANS List Learning (0-40), RBANS Story Memory (0-24), RBANS Figure Copy (0-20), RBANSLine Orientation (0-20), RBANS Semantic Fluency (0-unlimited), RBANS List Recall (0-10), RBANS List Recognition (0-20), RBANS Story Recall (0-12), RBANS Figure Recall (0-20), Digit Span Forward (0-16), Digit Span Backward (0-16), Boston Naming (0-15)."|20 minutes post-intranasal administration|||mean total correct responses||Standard Error|Mean
691783|NCT01436006|Primary|Value of Mean Volumetric Computed Tomography Dose Index (CTDI Vol) for Spine CT Examinations.||one year|||mGy||Standard Deviation|Mean
691784|NCT01436006|Primary|Value of Mean Volumetric Computed Tomography Dose Index (CTDI Vol) for Chest Abdomen and Pelvis CT Examinations.||one year|||mGy||Standard Deviation|Mean
691785|NCT01436006|Primary|Value of Mean Volumetric Computed Tomography Dose Index (CTDI Vol) for Cardiac CT Examinations.||one year|||mGy||Standard Deviation|Mean
691786|NCT01436006|Primary|Value of Mean Volumetric Computed Tomography Dose Index (CTDI Vol) for Abdomen CT Examinations.||one year|||mGy||Standard Deviation|Mean
691787|NCT01436006|Primary|Value of Mean Volumetric Computed Tomography Dose Index (CTDI Vol) for Chest CT Examinations.||one year|||mGy||Standard Deviation|Mean
691788|NCT01436006|Primary|Value of Mean Volumetric Computed Tomography Dose Index (CTDI Vol) for Head CT Examinations.||One year|||mGy||Standard Deviation|Mean
691789|NCT01435928|Secondary|Intent to Attend (ITA) Assessment at Open-label Baseline|The ITA assessment will be administered by a research staff member. The response is recorded on a 10-point scale, with 0 = “Not at all” and 9 = “Extremely”. The ITA allowed the site to capture data regarding dropout risk. The following question was completed at the screening visit: “How likely is it that you will complete the study?”|Open Label Baseline|All subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized.||units on a scale||Standard Deviation|Mean
691790|NCT01435928|Secondary|Smoking Questionnaire (Average Number of Cigarettes Per Day) at Week 28 (LOCF)|Smoking history and frequency were assessed during the study by a research staff member. During the study, smoked subjects were asked about the average number of cigarettes per day they smoked over the last week.|28 Weeks - Double Blind Phase|ITT Subjects who smoked||number of cigarettes smoked daily||Standard Deviation|Mean
691792|NCT01435928|Secondary|Brief Adherence Rating Scale|The Brief Adherence Rating Scale (BARS) is a clinician-administered adherence assessment instrument that consists of four items including three questions and a visual analog rating scale (VAS) to assess the percentage (0 - 100%) of doses taken by the subject in the previous month.|Double-blind phase - 28 Weeks|There were 6 Lurasidone subjects and 2 placebo subjects that had no post-baseline assessment.||percentage of monthly doses taken||Standard Deviation|Mean
691947|NCT01435031|Secondary|Resource Utilization: Fluoroscopic Time||Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||Minutes||Standard Deviation|Mean
691793|NCT01435928|Secondary|Change From Double-blind Baseline in Modified Specific Levels of Functioning (SLOF) Total Score|The modified SLOF scale is designed to measure directly observable behavioral functioning and daily living skills of patients with chronic mental illness. The modified SLOF consists of 24 items divided into two subscales: Social functioning (comprised of 7 items from interpersonal relationships section) and Community Living Skills (comprised of 17 items from activities and work skills sections). Each item is rated on a 5-point scale and mapped to 0 to 4 with a higher score indicating worse condition. The total score will be the sum of all 24 items and ranges from 0 to 96.|Double-blind phase - 28 Weeks|There were 19 Lurasidone subjects and 20 placebo subjects that had no post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
691794|NCT01435928|Secondary|Change From Double-blind Baseline in Short Form-12v2 Health Survey (SF-12v2) Physical Component Score|"The SF-12v2 is a self-administered, multipurpose short-form (SF) generic measure of health status. It was developed to be a shorter, yet valid, alternative to the SF-36 for use in large surveys of general and specific populations as well as in large longitudinal studies of health outcomes. The 12 items in the SF-12v2 are a subset of those in the SF-36; SF-12v2 includes one or two items from each of the eight health concepts with higher scores indicative of higher functioning and better health. The Physical Component Score is a composite of the Physical Functioning, Role Functioning, Bodily Pain and General Health scales.
Physical Composite Scores (PCS) is computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health."|Double-blind phase - 28 Weeks|There were 5 Lurasidone subjects and 3 placebo subjects that had no post-baseline SF-12 assessment.||units on a scale||Standard Error|Least Squares Mean
691795|NCT01435928|Secondary|Change From Double-blind Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|The MADRS consists of 10 items, each rated on a Likert scale, from 0=”Normal” to 6=”Most Severe”. The MADRS total score is calculated as the sum of the 10 items. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity.|Double-blind phase - 28 Weeks|There were four Lurasidone subjects and 2 placebo subjects that had no post-baseline MADRS assessment.||units on a scale||Standard Error|Least Squares Mean
691796|NCT01435928|Secondary|Change From Double-blind Baseline in Clinical Global Impression - Severity of Illness Scale (CGI-S) Score|The CGI-S score is a single value, clinician-rated assessment of illness severity and ranges from 1= ‘Normal, not at all ill’ to 7= ‘Among the most extremely ill patients’. A higher score is associated with greater illness severity.|Double-blind phase - 28 Weeks|||units on a scale||Standard Error|Least Squares Mean
691797|NCT01435928|Secondary|Change From Double-blind Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score|The PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items and three scales: the Positive scale contains seven questions to assess delusions, conceptual disorganization, hallucinations behavior, excitement, grandiosity, suspiciousness/persecution, and hostility; the Negative scale contains seven questions to assess blunted effect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, lack of motivation, and similar symptoms; and the General Psychopathology subscale addresses other symptoms such as anxiety, somatic concern, and disorientation. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity.|Double-Blind phase - 28 Weeks|||units on a scale||Standard Error|Least Squares Mean
691798|NCT01435928|Secondary|Time to All-cause Discontinuation|The Kaplan-Meier method was used for estimation.|Double-blind phase - 28 weeks|||days||95% Confidence Interval|Median
691799|NCT01435928|Primary|Time to First Relapse Event During Double-blind Phase|The Kaplan-Meier method is used for the estimation.|Double-blind phase - 28 Weeks|||days||95% Confidence Interval|Median
691800|NCT01435798|Secondary|Satisfaction|Satisfaction with study treatment assessed over the 7 days prior to admission (5-point categorical scale)|Last week prior to admission (end of 1-week maintenance period)|||Participants|||Count of Participants
691801|NCT01435798|Primary|Mean Pain Intensity (Percent Change From Baseline)|Primary outcome was percent change from baseline in mean pain intensity (transformed Gracely Scale; 0-35). Baseline was defined as the week prior to randomization. The greater the percent change, the bigger the reduction in pain intensity.|1st week of maintenance period (week prior to hospital admission for nested study; subjects traveled to Boston on days 6-7 of the maintenance period)|||Percent change from baseline||Standard Error|Mean
691802|NCT01435759|Primary|Change in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Total Score From Augmentation Baseline (Week 8) to Week 16 (Double-blind Phase, Dose Response Evaluable Set)|MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression. CHange in MADRS total score in Augmentsion Baseline to Week 16.|Augmentation Baseline (Week 8) to Week 16|Dose Response Evaluable Set (DRES): All randomized subjects who had at least 1 valid primary efficacy measurement (MADRS total score) during the Dose Maintenance Period (Weeks 11-16) while on the target dose level of investigational product.||units on a scale||90% Confidence Interval|Least Squares Mean
691803|NCT01435759|Secondary|Change in Average Pulse Rate From Augmentation Baseline (Week 8) to Week 16||From Augmentation Baseline (Week 8) to Week 16|Vital Signs Evaluable Set: All randomized subjects who had at least 1 valid vital signs measurement during the Dose Maintenance Period while on the target dose level of investigational product.||bpm||Standard Deviation|Mean
691804|NCT01435759|Secondary|Change in Average Diastolic Blood Pressure From Augmentation Baseline (Week 8) to Week 16||From Augmentation Baseline (Week 8) to Week 16|Vital Signs Evaluable Set: All randomized subjects who had at least 1 valid vital signs measurement during the Dose Maintenance Period while on the target dose level of investigational product.||mmHg||Standard Deviation|Mean
691805|NCT01435759|Secondary|Change in Average Systolic Blood Pressure From Augmentation Baseline (Week 8) to Week 16||From Augmentation Baseline (Week 8) to Week 16|Vital Signs Evaluable Set: All randomized subjects who had at least 1 valid vital signs measurement during the Dose Maintenance Period while on the target dose level of investigational product.||mmHg||Standard Deviation|Mean
691806|NCT01435655|Other Pre-specified|Plasma Concentration of Tafamidis at Week 8, Week 26, Week 52 and Week 78|Mean plasma concentration of tafamidis at 3 hours after administration|Week 8, Week 26, Week 52, Week 78|The PK Analysis Set included all participants treated who had at least 1 quantifiable plasma tafamidis concentration.||ng/mL||Standard Deviation|Mean
691807|NCT01435655|Secondary|Number of Participants With Transthyretin (TTR) Stabilization at Week 26, Week 52, and Week 78 Compared With Baseline as Measured by a Validated Immunoturbidimetric Assay|TTR tetramer was assessed using a validated immunoturbidimetric assay. The TTR tetramer level for each plasma sample was measured before and after urea denaturation. The Fraction of Initial (FOI) tetramer concentration is the ratio of the measured TTR tetramer concentration after denaturation to the measured TTR tetramer concentration before denaturation. TTR tetramer stabilization is based on the difference between the on-treatment FOI and the baseline FOI expressed as a percentage of the baseline FOI. A patient who has the “TTR stabilization” is defined as the patient whose percent stabilization is equal to or more than 32%.|Baseline, Week 26, Week 52, Week 78|Full Analysis Set (FAS) included all participants who received at least one dose of the study drug.||Participants|||Number
691808|NCT01435655|Secondary|Change From Baseline in Ambulatory Status at Week 26, Week 52 and Week 78|Ambulatory status was evaluated using walking ability scale in polyneuropathy disability score. The ambulatory status was evaluated as: 0=Good, 1=Sensory disturbances in the feet but able to walk without difficulty, 2=Some difficulties with walking but can walk without aid, 3a=Able to walk with 1 stick or crutch, 3b=Able to walk with 2 sticks or crutches, 4=Not ambulatory, confined to a wheelchair or bedridden.|Baseline, Week 26, Week 52, Week 78|Full Analysis Set (FAS) included all participants who received at least one dose of the study drug.||Participants|||Number
691809|NCT01435655|Secondary|Change From Baseline in Modified Body Mass Index (mBMI) at Week 8, Week 26, Week 52 and End of Study|The mBMI was calculated by multiplying the BMI (the weight in kilograms divided by the square of the height in meters) by serum albumin level (gram/liter). Change in mBMI was calculated as the mBMI at the given week minus the Baseline mBMI.|Baseline, Week 8, Week 26, Week 52, End of Study|Full Analysis Set (FAS) included all participants who received at least one dose of the study drug.||(kilogram/square meter)*(gram/liter)||Standard Deviation|Mean
691810|NCT01435655|Secondary|Change From Baseline in Summated 3 Nerve Tests Small Fiber Normal Deviate Score (∑ 3 NTSF Nds) as Measured by Cooling and Heat Pain Thresholds by QST and HRDB at Week 26, Week 52 and Week 78|The Σ3 NTSF nds measures small-fiber function. It is a composite score defined as 3 times the mean of non-missing values of normal deviates of cooling threshold for lower limbs, heat pain intermediate response for lower limbs, and HRDB. The total score range is approximately -11.2 to 11.2, with a higher score demonstrating worse nerve function.|Baseline, Week 26, Week 52, Week 78|Full Analysis Set (FAS) included all participants who received at least one dose of the study drug.||Units on a scale||Standard Deviation|Mean
691811|NCT01435655|Secondary|Change From Baseline in Summated 7 Nerve Tests Normal Deviate Score (∑ 7 NTs Nds) as Measured by Nerve Conduction Studies (NCS), Vibration Detection Threshold (VDT) and Heart Rate Response to Deep Breathing (HRDB) at Week 26, Week 52, and Week 78|The Σ7 NTs nds measures primarily large-fiber function. It is a composite score derived from five NCS attributes (peroneal nerve distal motor latency, peroneal nerve compound muscle action potential, peroneal nerve motor conduction velocity, tibial nerve distal motor latency, and sural nerve sensory nerve action potential amplitude) along with VDT obtained in great toes by Quantitative Sensory Testing (QST), and HRDB value. It is defined as 7 times the mean of non-missing values of, the five normal deviates of NCS, HRDB, and average normal deviate for VDT of toes. Score was determined through reference to normal values for age, sex, height and abnormalities scored. Total score range is approximately -26 to 26, where higher score=worse nerve function.|Baseline, Week 26, Week 52, Week 78|Full Analysis Set (FAS) included all participants who received at least one dose of the study drug.||Units on a scale||Standard Deviation|Mean
691812|NCT01435655|Secondary|Change From Baseline in Scores of the Total Quality of Life (TQOL) and 5 Domains as Measured by the Norfolk QOL – Diabetic Neuropathy (Norfolk QOL-DN) at Week 26, Week 52 and Week 78.|Norfolk QOL-DN is a 35-item participant-rated questionnaire. It consists of 5 domains: Physical Functioning/Large Fiber [score range: -4 – 56] , Activities of Daily Living (ADL) [0 - 20], Symptoms [0 - 32], Small Fiber [0 - 16] and Autonomic [0 - 12]. Total of quality of life (TQOL) score is the sum of all five domains with a range of -4 to 136 (Pfizer Data Standards). Higher scores on each item of the Norfolk QOL-DN TQOL indicate worse quality of life.|Baseline, Week 26, Week 52, Week 78|Full Analysis Set (FAS) included all participants who received at least one dose of the study drug.||Units on a scale||Standard Deviation|Mean
691813|NCT01435655|Secondary|Change From Baseline in Neuropathy Impairment Score (NIS); NIS (Total), NIS-LL (Lower Limb) and NIS-UL (Upper Limb) at Week 26, Week 52 and Week 78|The NIS provides a total body single score of neuropathic deficits (score range: 0-122, higher score = more deficit), comprising subset scores for cranial nerves, muscle weakness, reflexes, and sensation (based on mean of 2 scores in 1 week period; each item scored separately for left and right). The NIS-LL is a subscale that provides a score for the lower limbs functions (muscle weakness, reflexes and sensation in great toe) and has a score range of 0-44 (higher score = more deficit). The NIS-UL is a subscale that provides a score for the upper body functions (muscle weakness [including cranial nerves], reflexes and sensation in finger) and has a score range of 0-78 (higher score = more deficit). The components for cranial nerves and muscle weakness are scored from 0 (Normal) to 4 (Paralysis), and those for reflexes and sensation from 0 (Normal) to 2 (Absent). For all items, higher scores indicate greater impairment.|Baseline, Week 26, Week 52, Week 78|Full Analysis Set (FAS) included all participants who received at least one dose of the study drug.||Units on a scale||Standard Deviation|Mean
691814|NCT01435655|Primary|Number of Participants With Transthyretin (TTR) Stabilization at Week 8 Compared With Baseline as Measured by a Validated Immunoturbidimetric Assay|TTR tetramer level for each plasma sample was assessed using a validated immunoturbidimetric assay before and after urea denaturation. The Fraction of Initial (FOI) tetramer concentration is the ratio of the measured TTR tetramer concentration after denaturation to the measured TTR tetramer average concentration before denaturation. TTR tetramer stabilization is based on the difference between the on-treatment FOI and the baseline FOI expressed as a percentage of the baseline FOI. A patient who has the “TTR stabilization” is defined as the patient whose percent stabilization is equal to or more than 32%.|8 weeks|Full Analysis Set (FAS) included all participants who received at least one dose of the study drug.||Participants|||Number
691815|NCT01435577|Secondary|Mean Pain Intensity Scores at Relative Time - Matching Placebo Randomized Participants|The pain intensity at the relative time points are the pain intensity before and one hour after study drug administration. The pain intensity was measured using the Pain Intensity (PI). Pain intensity was assessed on 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine.|Baseline; for the first 6 administrations|Participants contributing data (indicated in brackets)||units on a scale||Standard Deviation|Mean
691816|NCT01435577|Secondary|Mean Pain Intensity Scores at Relative Time- Tapentadol Randomized Participants|The pain intensity at the relative time points are the pain intensity before and one hour after study drug administration. The pain intensity was measured using the Pain Intensity (PI). Pain intensity was assessed on 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine.|Baseline; for the first 6 administrations|Participants contributing data.||units on a scale||Standard Deviation|Mean
691817|NCT01435577|Secondary|Pharmacokinetic Concentrations of Tapentadol-O-glucuronide|"Tapentadol-O-glucuronide is the metabolite of tapentadol. Metabolites are sometimes referred to as breakdown products. The body alters the administered medication to a metabolite so that can be more easily or quickly removed from the body. Tapentadol-O-glucuronide concentrations were measured in participants in the tapentadol treatment arm. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 0.2 ng/mL."|15 minutes to 20 hours after first drug administration|Participants in the placebo arm were not analyzed. Only those participants contributing data were analyzed. Participants that had an early second study drug administration were not part of the analysis.||ng/mL||Full Range|Mean
691818|NCT01435577|Post-Hoc|Number of Participants Scored as a Responder Based on Patient Global Impression of Change|Responders are those participants with Patient Global Impression of Change (PGIC) values “Much improved”, or “Very much improved”. Participants with missing value are considered non-responders.|Fixed time points at 12, 24 and 48 hours after baseline|Participants with early second dose the PGIC assessment from End-of-double-blind Treatment was taken as the 48 hours value. Assessments done more than 4.5 hours after the 12th infusion were excluded from analysis and participants were considered non-responders.||participants|||Number
691819|NCT01435577|Secondary|Pharmacokinetic Concentrations of Tapentadol|Tapentadol concentrations were measured in participants in the tapentadol treatment arm. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 0.2 ng/mL.|15 minutes to 20 hours after first drug administration|Participants in the placebo arm were not analyzed. Only those participants contributing data were analyzed. Participants that had an early second study drug administration were not part of the analysis.||ng/mL||Full Range|Mean
691820|NCT01435577|Secondary|Time to Meaningful Pain Relief|The participant was instructed to stop the stopwatch when they had meaningful pain relief. That is, when the pain relief made a real difference, after the first drug administration.|up to 48 hours|Participants without pain relief (as measured by the double stopwatch method) were censored at 12 hours from the initial dose or at the time of early withdrawal from the Double-blind Treatment Period, whichever occurred first. Time in hours to meaningful pain relief are not reported for matching placebo arm due to the high discontinuation rate.||hours||95% Confidence Interval|Median
691821|NCT01435577|Secondary|Time to Perceptible Pain Relief|When the participant began to feel any pain-relieving effect after the administration of the first dose they were requested to stop the first stopwatch. The time was noted. This measured when the participant first felt any difference in the pain.|up to 48 hours|Participants without pain relief (as measured by the double stopwatch method) were censored at 12 hours from the initial dose or at the time of early withdrawal from the Double-blind Treatment Period, whichever occurred first. Time to perceptible pain relief is not reported for matching placebo arms because of the high number of discontinuations.||hours||95% Confidence Interval|Median
691822|NCT01435577|Secondary|Time to First Rescue Medication|The median time to first rescue medication intake (600 mg ibuprofen) in hours.|up to 48 hours|Full analysis set.||hours||95% Confidence Interval|Median
691823|NCT01435577|Secondary|Number of Participants With 50% Response After 48 Hours, Based on Pain Intensity Scores|Individual participant response. Number of participants that reported a 50% or more reduction in pain intensity from the administration of the first dose to 48 hours after the first study drug administration are counted as having a response if their pain intensity decreased by 50% from their baseline value.|Baseline value to 48 hours after first study drug administration|Full analysis set.||participants|||Number
691824|NCT01435577|Secondary|Number of Participants With 50% Response After 24 Hours, Based on Pain Intensity Scores|Individual participant response. Number of participants that reported a 50% or more reduction in pain intensity from the administration of the first dose to 24 hours after the first study drug administration are counted as having a response if their pain intensity decreased by 50% from their baseline value.|Baseline value to 24 hours after first study drug administration|Full analysis set.||participants|||Number
691825|NCT01435577|Secondary|Number of Participants With 50% Response After 12 Hours, Based on Pain Intensity Scores|Individual participant response. Number of participants that reported a 50% or more reduction in pain intensity from the administration of the first dose to 12 hours after the first study drug administration are counted as having a response if their pain intensity decreased by 50% from their baseline value.|Baseline value to 12 hours after first study drug administration|Full analysis set.||participants|||Number
691826|NCT01435577|Secondary|Number of Participants With 30% Response After 48 Hours, Based on Pain Intensity Scores|Individual participants response. Number of participants that reported a 30% or more reduction in pain intensity from the administration of the first dose to 48 hours after the first study drug administration are counted as having a response if their pain intensity decreased by 30% from their baseline value.|Baseline value to 48 hours after first study drug administration|Full analysis set.||participants|||Number
691827|NCT01435577|Secondary|Number of Participants With 30% Response After 24 Hours, Based on Pain Intensity Scores|Individual participant response. Number of participants that reported a 30% or more reduction in pain intensity from the administration of the first dose to 24 hours after the first study drug administration are counted as having a response if their pain intensity decreased by 30% from their baseline value.|Baseline value to 24 hours after first study drug administration|Full analysis set.||participants|||Number
691828|NCT01435577|Secondary|Number of Participants With 30% Response After 12 Hours, Based on Pain Intensity Scores|Individual participant response. Number of participants that reported a 30% or more reduction in pain intensity from the administration of the first dose to 12 hours after the first study drug administration are counted as having a response if their pain intensity decreased by 30% from their baseline value.|Baseline value to 12 hours after first study drug administration|Full analysis set.||participants|||Number
691857|NCT01435031|Secondary|Occurrence of Stent Fracture at Target Lesion|Assessed by fluoroscopy in patients undergoing clinically-driven angiographic follow-up.|3 years||||||
691829|NCT01435577|Secondary|Sum of Pain Intensity Differences After 48 Hours|Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between the PI after fixed times after first dose and the baseline PI (prior to the first dose). The Sum of Pain Intensity Differences over 60 minutes was calculated. If the values are negative (then the baseline pain intensity was greater than the pain intensity measured after dosing).|Baseline value to 48 hours after first study drug administration|Full Analysis Set.||units on a scale||95% Confidence Interval|Mean
691830|NCT01435577|Secondary|Sum of Pain Intensity Differences After 12 Hours|Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between the PI after fixed times after first dose and the baseline PI (prior to the first dose). The Sum of Pain Intensity Differences over 12 hours was calculated. If the values are negative (then the baseline pain intensity was greater than the pain intensity measured after dosing).|Baseline value to 12 hours after first study drug administration|Full Analysis Set.||units on a scale||95% Confidence Interval|Mean
691831|NCT01435577|Secondary|Sum of Pain Intensity Differences After 8 Hours|Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between the PI after fixed times after first dose and the baseline PI (prior to the first dose). The Sum of Pain Intensity Differences over 8 hours was calculated. If the values are negative (then the baseline pain intensity was greater than the pain intensity measured after dosing).|Baseline value to 8 hours after first study drug administration|Full Analysis Set.||units on a scale||95% Confidence Interval|Mean
691832|NCT01435577|Secondary|Sum of Pain Intensity Differences After 4 Hours|Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between the PI after fixed times after first dose and the baseline PI (prior to the first dose). The Sum of Pain Intensity Differences over 4 hours was calculated. If the values are negative (then the baseline pain intensity was greater than the pain intensity measured after dosing).|Baseline value to 4 hours after first study drug intake|Full analysis set. Primary imputation method was analyzed: Last Observation Carried Forward (LOCF) after dropout, and LOCF for 6 h after each rescue medication intake.||units on a scale||95% Confidence Interval|Mean
691833|NCT01435577|Secondary|Sum of Pain Intensity Differences After 60 Minutes|Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between the PI after fixed times after first dose and the baseline PI (prior to the first dose). The Sum of Pain Intensity Differences over 60 minutes was calculated. If the value is negative then the baseline pain intensity was greater than the pain intensity measured after dosing.|Baseline value to 60 minutes after first study drug administration|Full analysis set.||units on a scale||95% Confidence Interval|Mean
691834|NCT01435577|Secondary|Patient Global Impression of Change After 48 Hours of Treatment|In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant verbally rated their impression of overall status with 1 of 7 possible responses (very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse).|Baseline value to 48 hours after first study drug administration|Participants contributing data. Missing PGIC values were mainly due to participants discontinuing the trial before this time point.||participants|||Number
691835|NCT01435577|Secondary|Patients Global Impression of Change After 24 Hours of Treatment|In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant verbally rated their impression of overall status with 1 of 7 possible responses (very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse).|Baseline value to 24 hours after study drug administration|Participants contributing data. Missing PGIC values were mainly due to participants discontinuing the trial before this time point.||participants|||Number
691836|NCT01435577|Secondary|Patient Global Impression of Change After 12 Hours of Treatment|In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant verbally rated their impression of overall status with 1 of 7 possible responses (very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse).|Baseline value to 12 hours after first study drug administration|Participants contributing data. Missing PGIC values were mainly due to participants discontinuing the trial before this time point.||participants|||Number
691837|NCT01435577|Secondary|Pain Intensity Differences at Fixed Time Points|Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline pain intensity (prior to the first dose) and the pain intensity at the time. A negative number indicates a decrease in pain in the whole treatment group. The greater the negative pain intensity difference value the greater the pain relief in the treatment arm. A score of 0 indicates that there has been no change in pain in a treatment group. A positive value indicates an increase in pain in the treatment group.|Starting at 15 minutes and up to 48 hours after first drug administration|Full Analysis Set (FAS): Participants who took at least one dose of study medication, had a baseline value, and had at least one post-baseline measurement; Last Observation Carried Forward (LOCF) after dropout, and LOCF for 6 hours after each rescue medication intake.||units on a scale||Standard Deviation|Mean
691838|NCT01435577|Secondary|Mean Pain Intensity Scores at Fixed Time Points|The mean pain intensity at fixed time points in the trial for all participants is listed. The pain intensity was measured using the Pain Intensity (PI). Pain intensity was assessed on 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine.|Baseline; up to 48 hours|Full Analysis Set (FAS). Participants who took at least one dose of study medication, had a baseline value, and had at least one post-baseline measurement; Last Observation Carried Forward (LOCF) after dropout, and LOCF for 6 hours after each rescue medication intake.||units on a scale||Standard Deviation|Mean
691858|NCT01435031|Secondary|Occurrence of Stent Fracture at Target Lesion|Assessed by fluoroscopy in patients undergoing clinically-driven angiographic follow-up.|2 years|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||percentage of participants|||Number
698606|NCT01353963|Primary|Change From Baseline in Weight at Week 8.||Week 8|Safety population included all participants who received at least 1 dose of study medication during the observation period.||kg||Standard Deviation|Mean
691839|NCT01435577|Primary|Sum of Pain Intensity Differences (SPID 24)|"Pain Intensity assessed at predefined time points (at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 20 and 24 hours after first drug administration) over a 24 hour period using an 11-point Numeric Rating Scale (NRS) where a score of zero indicates no pain and a score of ten indicates pain as bad as you can imagine. Pain Intensity Differences at each predefined time point (calculated as post-baseline NRS values - baseline NRS values) were analyzed. Negative SPID24 values indicate a decrease in pain intensity and positive values indicate an increase in pain intensity since baseline."|Baseline value; up to 24 hours after first study drug administration|Full Analysis Set (FAS): patients who took at least one dose of study medication, had a baseline value, and had at least one post-baseline measurement; Last Observation Carried Forward (LOCF) after dropout, and LOCF for 6 hours after each rescue medication intake.||units on a scale||95% Confidence Interval|Least Squares Mean
691840|NCT01435460|Secondary|Ocular Itching|Ocular itching (symptom) evaluated using a grading scale from 0-4 where 0 = Absent and 4 = Severe|Change from baseline to day 8 (visit 2)|Participants analyzed from the per protocol (PP) population||units on a scale||Standard Deviation|Mean
691841|NCT01435460|Secondary|Bulbar Conjunctival Injection|Bulbar conjunctival injection (sign) evaluated using a grading scale from 0-3: where 0 = Absent and 3 = Severe|Change from baseline to day 8 (visit 2)|Participants analyzed from the per protocol (PP) population||units on a scale||Standard Deviation|Mean
691842|NCT01435460|Primary|Ocular Itching|Ocular itching (symptom) evaluated using a grading scale from 0-4 where 0 = Absent and 4 = Severe|Change from baseline to day 15 (visit 3)|Participants analyzed from the per protocol (PP) population||units on a scale||Standard Deviation|Mean
691843|NCT01435460|Primary|Bulbar Conjunctival Injection|Bulbar conjunctival injection (sign) evaluated using a grading scale from 0-3: where 0 = Absent and 3 = Severe|Change from baseline to day 15 (visit 3)|Participants analyzed from the per protocol (PP) population||units on a scale||Standard Deviation|Mean
691844|NCT01435265|Secondary|Adherence to Adalimumab Treatment|Adherence measured by average days between doses used, as measured by a Medication Event Monitoring System (MEMS) cap on the disposal container for used syringes.|Baseline to 12 months|All participants||days||Standard Deviation|Mean
691845|NCT01435265|Primary|Investigator's Global Assessment (IGA) of Psoriasis|Investigator's Global Assessment (IGA) is rated on a scale of 0 (clear) to 5 (very severe). The outcome measure to be reported is the number of patients who reached a final IGA of 0 (clear) or 1 (almost clear).|12 months|All participants completing the study.||participants|||Number
691846|NCT01435265|Primary|Change in Psoriasis Area Severity Index (PASI-75)|The Psoriasis Area Severity Index measures severity of psoriasis on a 0-6 scale for head, trunk, upper extremities, and lower extremities and amount of erythema, infiltration, and desquamation for each area. An overall score of 0-72 for the whole body is calculated from the observed severity values. Outcomes will be reported in terms of PASI 75, or number of participants showing at least 75% reduction in PASI score from baseline. Only final PASI 75 will be reported.|Baseline, 1 month, 3 months, 6 months, 9 months, 12 months|All participants who completed the study.||participants|||Number
691849|NCT01435122|Secondary|Occurrence of Possibly Related Adverse Events (AEs)|Grade 2 through 4 toxicities considered at least possibly related to treatment. Percentage of participants affected per category. Safety assessments will consist of monitoring and recording all adverse events and serious adverse events, the regular monitoring of hematology and blood chemistry parameters and regular physical examinations. Adverse events will be evaluated continuously throughout the study. Safety and tolerability will be assessed according to the National Institute of Health/National Cancer Institute (NIH/NCI) Common Terminology Criteria for Adverse Events version 4 (CTCAE v4) available at: http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm.|12 Months|All participants.||percentage of participants|||Number
691850|NCT01435122|Secondary|Time to Treatment Failure|Time to Treatment Failure: Time from administration of the initial dose of axitinib until study discontinuation for any reason (e.g., disease progression, toxicity, death, withdrawal of consent).|12 Months|All participants.||months||95% Confidence Interval|Median
691851|NCT01435122|Secondary|24 Month Overall Survival (OS) Rate|Overall survival by Kaplan Meier, determined from the time of drug administration to death from any cause. The effect of an intervention is assessed by measuring the number of subjects survived or saved after that intervention over a period of time. The time starting from a defined point to the occurrence of a given event, for example death is called as survival time and the analysis of group data as survival analysis.|24 months|All participants||percentage of participants|||Number
691852|NCT01435122|Secondary|Tumor Response Rate|Tumor response rate using RECIST. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.|12 Months|All participants evaluable at time of analysis.||Participants|||Count of Participants
691853|NCT01435122|Primary|Median Progression Free Survival|Post follow-up progression free survival at time of analysis.|Up to 36 Months|All participants.||months||95% Confidence Interval|Median
691854|NCT01435122|Primary|Rate of Progression Free Survival (PFS)|Progression-free survival rate at 12 months. PFS: determined as the time from administration of the initial dose of axitinib until objective tumor progression using Response Evaluation Criteria In Solid Tumors (RECIST), or death. Progressive Disease (PD) Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase. Stable Disease (SD): Neither sufficient shrinkage to qualify for Partial Response (PR) nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|12 Months|All participants.||percentage of participants|||Number
691855|NCT01435031|Secondary|Occurrence of Stent Fracture at Target Lesion|Assessed by fluoroscopy in patients undergoing clinically-driven angiographic follow-up.|5 years||||||
691856|NCT01435031|Secondary|Occurrence of Stent Fracture at Target Lesion|Assessed by fluoroscopy in patients undergoing clinically-driven angiographic follow-up.|4 years||||||
691860|NCT01435031|Secondary|Stent Thrombosis|"Academic Research Consortium (ARC) criteria.
Definite stent thrombosis as defined by ARC criteria: angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy).
Probable stent thrombosis as defined by ARC criteria: any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause."|5 years||||||
691861|NCT01435031|Secondary|Stent Thrombosis|"Academic Research Consortium (ARC) criteria.
Definite stent thrombosis as defined by ARC criteria: angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy).
Probable stent thrombosis as defined by ARC criteria: any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause."|4 years||||||
691862|NCT01435031|Secondary|Stent Thrombosis|"Academic Research Consortium (ARC) criteria.
Definite stent thrombosis as defined by ARC criteria: angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy).
Probable stent thrombosis as defined by ARC criteria: any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause."|3 years||||||
691863|NCT01435031|Secondary|Stent Thrombosis|"Academic Research Consortium (ARC) criteria.
Definite stent thrombosis as defined by ARC criteria: angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy).
Probable stent thrombosis as defined by ARC criteria: any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause."|2 years|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||Participants|||Count of Participants
691864|NCT01435031|Secondary|Stent Thrombosis|"Academic Research Consortium (ARC) criteria; definite and probable.
Definite stent thrombosis as defined by ARC criteria: angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy).
Probable stent thrombosis as defined by ARC criteria: any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause."|1 year|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||Participants|||Count of Participants
691865|NCT01435031|Secondary|Stent Thrombosis|"Academic Research Consortium (ARC) criteria; definite and probable.
Definite stent thrombosis as defined by ARC criteria: angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy).
Probable stent thrombosis as defined by ARC criteria: any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause."|Late (>30 days to 1 year)|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||Participants|||Count of Participants
691866|NCT01435031|Secondary|Stent Thrombosis|"Academic Research Consortium (ARC) criteria; definite and probable. Definite stent thrombosis as defined by ARC criteria: angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy).
Probable stent thrombosis as defined by ARC criteria: any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause."|Subacute (>24 hours to 30 days)|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||Participants|||Count of Participants
691867|NCT01435031|Secondary|Stent Thrombosis|"Academic Research Consortium (ARC) criteria; definite and probable
Definite stent thrombosis as defined by ARC criteria: angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy).
Probable stent thrombosis as defined by ARC criteria: any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause."|Acute (0-24 hours)|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||percentage of participants||95% Confidence Interval|Number
691868|NCT01435031|Secondary|Target Lesion Failure (TLF)|Composite of cardiac death, target vessel-related MI, and clinically-driven TLR|5 years||||||
691869|NCT01435031|Secondary|Target Lesion Failure (TLF)|Composite of cardiac death, target vessel-related MI, and clinically-driven TLR|4 years||||||
691870|NCT01435031|Secondary|Target Lesion Failure (TLF)|Composite of cardiac death, target vessel-related MI, and clinically-driven TLR|3 years||||||
738604|NCT00450749|Secondary|Expression of GST-pi in Prostatic Surgical Tissue||At 4-7 weeks||||||
691875|NCT01435031|Secondary|Target Vessel Failure (TVF)|"Composite endpoint comprised of cardiac death, target vessel MI, or clinically-driven target vessel revascularization. Per protocol.
Target vessel failure will be reported when ANY of the following events occur:
Recurrent MI occurs in territory not clearly attributed to a vessel other than the target vessel.
Cardiac death not clearly due to a non-target vessel endpoint.
Target vessel revascularization is determined."|5 years||||||
691876|NCT01435031|Secondary|Target Vessel Failure (TVF)|"Composite endpoint comprised of cardiac death, target vessel MI, or clinically-driven target vessel revascularization. Per protocol.
Target vessel failure will be reported when ANY of the following events occur:
Recurrent MI occurs in territory not clearly attributed to a vessel other than the target vessel.
Cardiac death not clearly due to a non-target vessel endpoint.
Target vessel revascularization is determined."|4 years||||||
691877|NCT01435031|Secondary|Target Vessel Failure (TVF)|"Composite endpoint comprised of cardiac death, target vessel MI, or clinically-driven target vessel revascularization. Per protocol.
Target vessel failure will be reported when ANY of the following events occur:
Recurrent MI occurs in territory not clearly attributed to a vessel other than the target vessel.
Cardiac death not clearly due to a non-target vessel endpoint.
Target vessel revascularization is determined."|3 years||||||
691878|NCT01435031|Secondary|Target Vessel Failure (TVF)|"Composite endpoint comprised of cardiac death, target vessel MI, or clinically-driven target vessel revascularization. Per protocol.
Target vessel failure will be reported when ANY of the following events occur:
Recurrent MI occurs in territory not clearly attributed to a vessel other than the target vessel.
Cardiac death not clearly due to a non-target vessel endpoint.
Target vessel revascularization is determined."|2 years|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||Participants|||Count of Participants
691879|NCT01435031|Secondary|Target Vessel Failure (TVF)|"Composite endpoint comprised of cardiac death, target vessel MI, or clinically-driven target vessel revascularization. Per protocol.
Target vessel failure will be reported when ANY of the following events occur:
Recurrent MI occurs in territory not clearly attributed to a vessel other than the target vessel.
Cardiac death not clearly due to a non-target vessel endpoint.
Target vessel revascularization is determined."|1 year|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||Participants|||Count of Participants
691880|NCT01435031|Secondary|Target Vessel Failure (TVF)|"Composite endpoint comprised of cardiac death, target vessel MI, or clinically-driven target vessel revascularization. Per protocol.
Target vessel failure will be reported when ANY of the following events occur:
Recurrent MI occurs in territory not clearly attributed to a vessel other than the target vessel.
Cardiac death not clearly due to a non-target vessel endpoint.
Target vessel revascularization is determined."|6 months|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||Participants|||Count of Participants
691881|NCT01435031|Secondary|Target Vessel Failure (TVF)|"Composite endpoint comprised of cardiac death, target vessel MI, or clinically-driven target vessel revascularization. Per protocol.
Target vessel failure will be reported when any of the following events occur:
Recurrent MI occurs in territory not clearly attributed to a vessel other than the target vessel.
Cardiac death not clearly due to a non-target vessel endpoint.
Target vessel revascularization is determined."|30 days|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||Participants|||Count of Participants
691882|NCT01435031|Secondary|Clinically-Driven Target Vessel Revascularization (Clinically-Driven TVR)|Revascularization in the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target vessel with diameter stenosis >= 70% by QCA without either angina or a positive functional study.|5 years||||||
691883|NCT01435031|Secondary|Clinically-Driven Target Vessel Revascularization (Clinically-Driven TVR)|Revascularization in the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target vessel with diameter stenosis >= 70% by QCA without either angina or a positive functional study.|4 years||||||
691884|NCT01435031|Secondary|Clinically-Driven Target Vessel Revascularization (Clinically-Driven TVR)|Revascularization in the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target vessel with diameter stenosis >= 70% by QCA without either angina or a positive functional study.|3 years||||||
691885|NCT01435031|Secondary|Clinically-Driven Target Vessel Revascularization (Clinically-Driven TVR)|Revascularization in the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target vessel with diameter stenosis >= 70% by QCA without either angina or a positive functional study.|2 years|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||Participants|||Count of Participants
691886|NCT01435031|Secondary|Clinically-Driven Target Vessel Revascularization (Clinically-Driven TVR)|Revascularization in the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target vessel with diameter stenosis >= 70% by QCA without either angina or a positive functional study.|1 year|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||Participants|||Count of Participants
691887|NCT01435031|Secondary|Clinically-Driven Target Vessel Revascularization (Clinically-Driven TVR)|Revascularization in the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target vessel with diameter stenosis >= 70% by QCA without either angina or a positive functional study.|6 months|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||Participants|||Count of Participants
691888|NCT01435031|Secondary|Clinically-Driven Target Vessel Revascularization (Clinically-Driven TVR)|Revascularization in the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target vessel with diameter stenosis >= 70% by QCA without either angina or a positive functional study.|30 days|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||Participants|||Count of Participants
691896|NCT01435031|Secondary|Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR)|TLF and MACE component. Revascularization at the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target lesion with diameter stenosis >= 70% by QCA without either angina or a positive functional study.|5 years||||||
691897|NCT01435031|Secondary|Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR)|TLF and MACE component. Revascularization at the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target lesion with diameter stenosis >= 70% by QCA without either angina or a positive functional study.|4 years||||||
691898|NCT01435031|Secondary|Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR)|TLF and MACE component. Revascularization at the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target lesion with diameter stenosis >= 70% by QCA without either angina or a positive functional study.|3 years||||||
691899|NCT01435031|Secondary|Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR)|TLF and MACE component. Revascularization at the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target lesion with diameter stenosis >= 70% by QCA without either angina or a positive functional study.|2 years|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||Participants|||Count of Participants
691900|NCT01435031|Secondary|Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR)|TLF and MACE component. Revascularization at the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target lesion with diameter stenosis >= 70% by QCA without either angina or a positive functional study.|1 year|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||Participants|||Count of Participants
691901|NCT01435031|Secondary|Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR)|TLF and MACE component. Revascularization at the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target lesion with diameter stenosis >= 70% by QCA without either angina or a positive functional study.|6 months|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||Participants|||Count of Participants
691902|NCT01435031|Secondary|Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR)|TLF and MACE component. Revascularization at the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target lesion with diameter stenosis >= 70% by QCA without either angina or a positive functional study.|30 days|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||Participants|||Count of Participants
691903|NCT01435031|Secondary|Target Lesion Revascularization (TLR)|Repeat PCI or CABG to the target lesion/site.|5 years||||||
691904|NCT01435031|Secondary|Target Lesion Revascularization (TLR)|Repeat PCI or CABG to the target lesion/site.|4 years||||||
691905|NCT01435031|Secondary|Target Lesion Revascularization (TLR)|Repeat PCI or CABG to the target lesion/site.|3 years||||||
691906|NCT01435031|Secondary|Target Lesion Revascularization (TLR)|Repeat PCI or CABG to the target lesion/site.|2 years|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||Participants|||Count of Participants
691907|NCT01435031|Secondary|Target Lesion Revascularization (TLR)|Repeat PCI or CABG to the target lesion/site.|1 year|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||Participants|||Count of Participants
691908|NCT01435031|Secondary|Target Lesion Revascularization (TLR)|Repeat PCI or CABG to the target lesion/site.|6 months|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||Participants|||Count of Participants
691909|NCT01435031|Secondary|Target Lesion Revascularization (TLR)|Repeat percutaneous coronary intervention (PCI) or Coronary artery bypass graft (CABG) to the target lesion/site.|30 days|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||Participants|||Count of Participants
691910|NCT01435031|Secondary|Target Vessel-related MI|"TLF Component; per protocol
Target vessel-related MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel."|5 years||||||
691911|NCT01435031|Secondary|Target Vessel-related MI|"TLF Component; per protocol
Target vessel-related MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel."|4 years||||||
691912|NCT01435031|Secondary|Target Vessel-related MI|"TLF Component; per protocol
Target vessel-related MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel."|3 years||||||
691913|NCT01435031|Secondary|Target Vessel-related MI|"TLF Component; per protocol
Target vessel-related MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel."|2 years|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||Participants|||Count of Participants
691914|NCT01435031|Secondary|Target Vessel-related MI|"TLF Component; per protocol
Target vessel-related MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel."|1 year|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||Participants|||Count of Participants
691915|NCT01435031|Secondary|Target Vessel-related MI|"TLF Component; per protocol
Target vessel-related MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel."|6 months|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||Participants|||Count of Participants
699283|NCT00002540|Secondary|T3 DRE Screening Results|Digital Rectal examination (DRE) result|T3 (three years after entry)|All males in the Prostate Screening arm who had a DRE screen at T3 were analyzed.||Participants|||Number
691916|NCT01435031|Secondary|Target Vessel-related MI|"TLF Component; per protocol
Target vessel-related MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel."|30 days|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||Participants|||Count of Participants
691917|NCT01435031|Secondary|Myocardial Infarction Q Wave and Non-Q Wave (MI)|"MACE Component; per protocol. Myocardial Infarction (Protocol Definition)
Q wave MI: development of new, pathological Q wave on the ECG
Non-Q-wave MI: elevation of CK levels to ≥ 2 x ULN with elevated CK-MB in the absence of new pathological Q waves"|5 years||||||
691918|NCT01435031|Secondary|Myocardial Infarction Q Wave and Non-Q Wave (MI)|"MACE Component; per protocol. Myocardial Infarction (Protocol Definition)
Q wave MI: development of new, pathological Q wave on the ECG
Non-Q-wave MI: elevation of CK levels to ≥ 2 x ULN with elevated CK-MB in the absence of new pathological Q waves"|4 years||||||
691919|NCT01435031|Secondary|Myocardial Infarction Q Wave and Non-Q Wave (MI)|"MACE Component; per protocol. Myocardial Infarction (Protocol Definition)
Q wave MI: development of new, pathological Q wave on the ECG
Non-Q-wave MI: elevation of CK levels to ≥ 2 x ULN with elevated CK-MB in the absence of new pathological Q waves"|3 years||||||
691920|NCT01435031|Secondary|Myocardial Infarction Q Wave and Non-Q Wave (MI)|"MACE Component; per protocol. Myocardial Infarction (Protocol Definition)
Q wave MI: development of new, pathological Q wave on the ECG
Non-Q-wave MI: elevation of CK levels to ≥ 2 x ULN with elevated CK-MB in the absence of new pathological Q waves"|2 years|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||Participants|||Count of Participants
691921|NCT01435031|Secondary|Myocardial Infarction Q Wave and Non-Q Wave (MI)|"MACE Component; per protocol. Myocardial Infarction (Protocol Definition)
Q wave MI: development of new, pathological Q wave on the ECG
Non-Q-wave MI: elevation of CK levels to ≥ 2 x ULN with elevated CK-MB in the absence of new pathological Q waves"|1 year|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||Participants|||Count of Participants
691922|NCT01435031|Secondary|Myocardial Infarction Q Wave and Non-Q Wave (MI)|"MACE Component; per protocol. Myocardial Infarction (Protocol Definition)
Q wave MI: development of new, pathological Q wave on the ECG
Non-Q-wave MI: elevation of CK levels to ≥ 2 x ULN with elevated CK-MB in the absence of new pathological Q waves"|6 months|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||Participants|||Count of Participants
691923|NCT01435031|Secondary|Myocardial Infarction Q Wave and Non-Q Wave (MI)|"MACE Component; per protocol
Myocardial Infarction (Protocol Definition)
Q wave MI: development of new, pathological Q wave on the ECG
Non-Q-wave MI: elevation of CK levels to ≥ 2 x upper limit of normal (ULN) with elevated Creatine kinase myocardial-band isoenzyme (CK-MB) in the absence of new pathological Q waves"|30 days|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||Participants|||Count of Participants
691924|NCT01435031|Secondary|Cardiac Death|"TLF component.
Cardiac death was defined as death due to any of the following:
Acute MI
Cardiac perforation/pericardial tamponade
Arrhythmia or conduction abnormality
Stroke within 30 days of the procedure or stroke suspected of being related to the procedure
Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery
Any death in which a cardiac cause cannot be excluded"|5 years||||||
691925|NCT01435031|Secondary|Cardiac Death|"TLF component.
Cardiac death was defined as death due to any of the following:
Acute MI
Cardiac perforation/pericardial tamponade
Arrhythmia or conduction abnormality
Stroke within 30 days of the procedure or stroke suspected of being related to the procedure
Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery
Any death in which a cardiac cause cannot be excluded"|4 years||||||
691926|NCT01435031|Secondary|Cardiac Death|"TLF component.
Cardiac death was defined as death due to any of the following:
Acute MI
Cardiac perforation/pericardial tamponade
Arrhythmia or conduction abnormality
Stroke within 30 days of the procedure or stroke suspected of being related to the procedure
Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery
Any death in which a cardiac cause cannot be excluded"|3 years||||||
691927|NCT01435031|Secondary|Cardiac Death|"TLF component.
Cardiac death was defined as death due to any of the following:
Acute MI
Cardiac perforation/pericardial tamponade
Arrhythmia or conduction abnormality
Stroke within 30 days of the procedure or stroke suspected of being related to the procedure
Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery
Any death in which a cardiac cause cannot be excluded"|2 years|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||Participants|||Count of Participants
691928|NCT01435031|Secondary|Cardiac Death|"TLF component.
Cardiac death was defined as death due to any of the following:
Acute MI
Cardiac perforation/pericardial tamponade
Arrhythmia or conduction abnormality
Stroke within 30 days of the procedure or stroke suspected of being related to the procedure
Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery
Any death in which a cardiac cause cannot be excluded"|1 year|ITT set||Participants|||Count of Participants
691929|NCT01435031|Secondary|Cardiac Death|"TLF component.
Cardiac death was defined as death due to any of the following:
Acute MI
Cardiac perforation/pericardial tamponade
Arrhythmia or conduction abnormality
Stroke within 30 days of the procedure or stroke suspected of being related to the procedure
Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery
Any death in which a cardiac cause cannot be excluded"|6 months|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||Participants|||Count of Participants
691930|NCT01435031|Secondary|Cardiac Death|"TLF component.
Cardiac death was defined as death due to any of the following:
Acute MI
Cardiac perforation/pericardial tamponade
Arrhythmia or conduction abnormality
Stroke within 30 days of the procedure or stroke suspected of being related to the procedure
Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery
Any death in which a cardiac cause cannot be excluded"|30 days|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||Participants|||Count of Participants
694336|NCT01402102|Secondary|Changes in HDL-Cholesterol(High Density Lipoprotein - Cholesterol)|HDL-cholesterol(High Density Lipoprotein - cholesterol) was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|PP analysis||mg/dl||Standard Deviation|Mean
691931|NCT01435031|Secondary|Death|"MACE Component; per protocol.
Death is divided into 2 categories:
Cardiac death is defined as death due to any of the following:
Acute MI
Cardiac perforation/pericardial tamponade
Arrhythmia or conduction abnormality
Stroke within 30 days of the procedure or stroke suspected of being related to the procedure
Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery
Any death in which a cardiac cause cannot be excluded.
Non-cardiac death is defined as a death not due to cardiac causes (as defined above)."|5 years||||||
691932|NCT01435031|Secondary|Death|"MACE Component; per protocol.
Death is divided into 2 categories:
Cardiac death is defined as death due to any of the following:
Acute MI
Cardiac perforation/pericardial tamponade
Arrhythmia or conduction abnormality
Stroke within 30 days of the procedure or stroke suspected of being related to the procedure
Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery
Any death in which a cardiac cause cannot be excluded.
Non-cardiac death is defined as a death not due to cardiac causes (as defined above)."|4 years||||||
691933|NCT01435031|Secondary|Death|"MACE Component; per protocol.
Death is divided into 2 categories:
Cardiac death is defined as death due to any of the following:
Acute MI
Cardiac perforation/pericardial tamponade
Arrhythmia or conduction abnormality
Stroke within 30 days of the procedure or stroke suspected of being related to the procedure
Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery
Any death in which a cardiac cause cannot be excluded.
Non-cardiac death is defined as a death not due to cardiac causes (as defined above)."|3 years||||||
691934|NCT01435031|Secondary|Death|"MACE Component; per protocol.
Death is divided into 2 categories:
Cardiac death is defined as death due to any of the following:
Acute MI
Cardiac perforation/pericardial tamponade
Arrhythmia or conduction abnormality
Stroke within 30 days of the procedure or stroke suspected of being related to the procedure
Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery
Any death in which a cardiac cause cannot be excluded.
Non-cardiac death is defined as a death not due to cardiac causes (as defined above)."|2 years|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||Participants|||Count of Participants
691935|NCT01435031|Secondary|Death|"MACE Component; per protocol.
Death is divided into 2 categories:
Cardiac death is defined as death due to any of the following:
Acute MI
Cardiac perforation/pericardial tamponade
Arrhythmia or conduction abnormality
Stroke within 30 days of the procedure or stroke suspected of being related to the procedure
Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery
Any death in which a cardiac cause cannot be excluded.
Non-cardiac death is defined as a death not due to cardiac causes (as defined above)."|1 year|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||Participants|||Count of Participants
691936|NCT01435031|Secondary|Death|"MACE Component; per protocol.
Death is divided into 2 categories:
Cardiac death is defined as death due to any of the following:
Acute MI
Cardiac perforation/pericardial tamponade
Arrhythmia or conduction abnormality
Stroke within 30 days of the procedure or stroke suspected of being related to the procedure
Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery
Any death in which a cardiac cause cannot be excluded.
Non-cardiac death is defined as a death not due to cardiac causes (as defined above)."|6 months|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||Participants|||Count of Participants
691937|NCT01435031|Secondary|Death|"MACE Component; per protocol.
Death is divided into 2 categories:
Cardiac death is defined as death due to any of the following:
Acute MI
Cardiac perforation/pericardial tamponade
Arrhythmia or conduction abnormality
Stroke within 30 days of the procedure or stroke suspected of being related to the procedure
Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery
Any death in which a cardiac cause cannot be excluded.
Non-cardiac death is defined as a death not due to cardiac causes (as defined above)."|30 days|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||Participants|||Count of Participants
691938|NCT01435031|Secondary|Major Adverse Cardiac Events (MACE)|Per protocol. Defined as death, MI (Q wave and non-Q wave) or clinically-driven target lesion revascularization.|5 years||||||
691939|NCT01435031|Secondary|Major Adverse Cardiac Events (MACE)|Per protocol. Defined as death, MI (Q wave and non-Q wave) or clinically-driven target lesion revascularization.|4 years||||||
691940|NCT01435031|Secondary|Major Adverse Cardiac Events (MACE)|Per protocol. Defined as death, MI (Q wave and non-Q wave) or clinically-driven target lesion revascularization.|3 years||||||
691941|NCT01435031|Secondary|Major Adverse Cardiac Events (MACE)|Per protocol. Defined as death, MI (Q wave and non-Q wave) or clinically-driven target lesion revascularization.|2 years|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||Participants|||Count of Participants
691942|NCT01435031|Secondary|Major Adverse Cardiac Events (MACE)|Per protocol. Defined as death, MI (Q wave and non-Q wave) or clinically-driven target lesion revascularization.|1 year|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||Participants|||Count of Participants
691943|NCT01435031|Secondary|Major Adverse Cardiac Events (MACE)|Per protocol. Defined as death, MI (Q wave and non-Q wave) or clinically-driven target lesion revascularization.|6 months|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||Participants|||Count of Participants
691944|NCT01435031|Secondary|Major Adverse Cardiac Events (MACE)|Per protocol. Defined as death, MI (Q wave and non-Q wave) or clinically-driven target lesion revascularization.|30 days|ITT set.The number of participants analyzed include subjects who had available follow up data at that time frame.||Participants|||Count of Participants
691945|NCT01435031|Secondary|Clinically Significant Perforation|Any perforation resulting in hemodynamic instability and/or requiring intervention including pericardiocentesis, embolization, prolonged balloon occlusion, stent graft or comparable therapy|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT.The number of participants analyzed include subjects who had available follow up data at that time frame.||percentage of participants||95% Confidence Interval|Number
691946|NCT01435031|Secondary|Resource Utilization: Contrast Volume||Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||mL||Standard Deviation|Mean
691948|NCT01435031|Secondary|Resource Utilization: Procedural Time||Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||Minutes||Standard Deviation|Mean
691949|NCT01435031|Secondary|Procedural Success With Multiple Crossing Techniques|per protocol|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set. The number of participants analyzed include the numbers of subjects with corresponding crossing method that were evaluable for procedural success.||percentage of participants|||Number
691950|NCT01435031|Secondary|Procedural Success With Sub Intimal Technique|per protocol|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set. The number of participants analyzed include the numbers of subjects with corresponding crossing method that were evaluable for procedural success.||percentage of participants|||Number
691951|NCT01435031|Secondary|Procedural Success With Kissing Wire Technique|per protocol; combined antegrade and retrograde crossing method|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set.The number of participants analyzed include the numbers of subjects with corresponding crossing method that were evaluable for procedural success.||percentage of participants|||Number
691952|NCT01435031|Secondary|Procedural Success With Reverse CART|per protocol|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set. The number of participants analyzed include the numbers of subjects with corresponding crossing method that were evaluable for procedural success.||percentage of participants|||Number
691953|NCT01435031|Secondary|Procedural Success With Controlled Antegrade-Retrograde Technique (CART)|per protocol|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set. The number of participants analyzed include the numbers of subjects with corresponding crossing method that were evaluable for procedural success.||percentage of participants|||Number
691954|NCT01435031|Secondary|Procedural Success With Primary Retrograde Wire Crossing|per protocol|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set. The number of participants analyzed include the numbers of subjects with corresponding crossing method that were evaluable for procedural success.||percentage of participants|||Number
691955|NCT01435031|Secondary|Procedural Success With Knuckle Wire|per protocol; antegrade crossing method|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set. The number of participants analyzed include the numbers of subjects with corresponding crossing method that were evaluable for procedural success.||percentage of participants|||Number
691956|NCT01435031|Secondary|Procedural Success With Subintimal Tracking and Re-entry (STAR) Technique|per protocol; antegrade crossing method|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set. The number of participants analyzed include the numbers of subjects with corresponding crossing method that were evaluable for procedural success.||percentage of participants|||Number
691957|NCT01435031|Secondary|Procedural Success With Antegrade Crossing|per protocol|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set. The number of participants analyzed include the numbers of subjects with corresponding crossing method that were evaluable for procedural success.||percentage of participants|||Number
691958|NCT01435031|Secondary|Procedure Success|"Device success and absence of in-hospital MACE.
Per-protocol MI definition: Myocardial infarctions per protocol definition were categorized as Q-wave (development of new, pathological Q waves on the ECG) or non-Q-wave (elevation of CK levels to greater than two times the upper limit of normal and elevated CK-MB in the absence of new pathological Q waves).
Per ARC MI definition: Myocardial infarctions per ARC definition were also categorized as Q-wave (development of new pathological Q waves in 2 or more contiguous leads (according to the Minnesota code) with or without post-procedure CK or CK-MB levels elevated above normal) or non-Q-wave (all MIs not classified as Q-wave). ARC defined MIs were further classified as Periprocedural PCI, Periprocedural CABG, Spontaneous, Sudden Death, and Reinfarction based on biomarker and additional criteria and as ST Elevation MI (STEMI) or Non-ST Elevation MI (NSTEMI) based on ST segment."|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||percentage of participants||95% Confidence Interval|Number
691959|NCT01435031|Secondary|Device Success|Achievement of <50% diameter stenosis within the target lesion segment using assigned study device|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||percentage of participants||95% Confidence Interval|Number
691960|NCT01435031|Secondary|Change in TIMI Flow Grade: Post-procedure|"Pre- and post predilatation with the MINI-TREK Coronary Dilatation Catheter.
TIMI Classification:
TIMI 0 No perfusion.
TIMI 1 Penetration with minimal perfusion. Contrast fails to opacify the entire bed distal to the stenosis for the duration of the cine run.
TIMI 2 Partial perfusion. Contrast opacifies the entire coronary bed distal to the stenosis. However, the rate of entry and/or clearance is slower in the coronary bed distal to the obstruction than in comparable areas not perfused by the dilated vessel.
TIMI 3 Complete perfusion. Filling and clearance of contrast equally rapid in the coronary bed distal to stenosis as in other coronary beds."|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||percentage of participants||95% Confidence Interval|Number
691961|NCT01435031|Secondary|Change in Thrombolysis in Myocardial Infarction (TIMI) Flow Grade: Pre-procedure|"Pre- and post predilatation with the MINI-TREK Coronary Dilatation Catheter.
TIMI Classification:
TIMI 0 No perfusion.
TIMI 1 Penetration with minimal perfusion. Contrast fails to opacify the entire bed distal to the stenosis for the duration of the cine run.
TIMI 2 Partial perfusion. Contrast opacifies the entire coronary bed distal to the stenosis. However, the rate of entry and/or clearance is slower in the coronary bed distal to the obstruction than in comparable areas not perfused by the dilated vessel.
TIMI 3 Complete perfusion. Filling and clearance of contrast equally rapid in the coronary bed distal to stenosis as in other coronary beds."|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set.The number of participants analyzed include subjects who had available follow up data at that time frame.||percentage of participants||95% Confidence Interval|Number
691962|NCT01435031|Secondary|Minimum Lumen Diameter (MLD): Post-procedure|"Pre- and post predilatation with the MINI-TREK Coronary Dilatation Catheter.
MLD is the average of 2 orthogonal views (when possible) of the narrowest point within the area of assessment – in lesion, in stent, or in segment. MLD is visually estimated during angiography by the Investigator; it is measured during QCA by the Angiographic Core Laboratory."|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||mm||Standard Deviation|Mean
691963|NCT01435031|Secondary|Minimum Lumen Diameter (MLD): Pre-procedure|"Pre- and post predilatation with the MINI-TREK Coronary Dilatation Catheter.
MLD is the average of 2 orthogonal views (when possible) of the narrowest point within the area of assessment – in lesion, in stent, or in segment. MLD is visually estimated during angiography by the Investigator; it is measured during Quantitative coronary angiography (QCA) by the Angiographic Core Laboratory."|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||mm||Standard Deviation|Mean
691964|NCT01435031|Primary|Angioplasty Predilatation-related: Successful Predilatation of the CTO|"Successful delivery of the MINI-TREK Coronary Dilatation Catheter to and across the target lesion and;
Successful inflation and deflation of the MINI-TREK Coronary Dilatation Catheter and;
Absence of clinically significant vessel perforation, flow-limiting vessel dissection, reduction in thrombolysis in myocardial infarction (TIMI) from baseline or clinically significant arrhythmias requiring medical treatment or device intervention following dilatation with MINI-TREK and;
Achievement of final TIMI flow 3 for the target lesion at the conclusion of the index procedure"|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|Angiographically Evaluable Subjects||percentage of participants||95% Confidence Interval|Number
691965|NCT01435031|Primary|Guide Wire-related: Successful Recanalization of the CTO (MACE Includes Per Protocol Definition of MI)|"Successful recanalization of the CTO defined as:
Confirmation of placement of the guide wire in the distal true lumen (component 1)
Absence of in-hospital MACE, based on protocol MI (component 2)"|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|All the subjects who met the study entry criteria, signed the written informed consent, were enrolled in the trial and in whom an attempt was made to cross the target lesion with the HT Progress or the HT Pilot guide wires, are included in the ITT population for the guide wire-related analysis.||percentage of participants||95% Confidence Interval|Number
691966|NCT01435031|Primary|Guide Wire-related: Successful Recanalization of the Chronic Total Occlusion (CTO) (MACE Includes Per ARC Definition of MI)|"Successful recanalization of the CTO defined as:
Confirmation of placement of the guide wire in the distal true lumen (component 1)
Absence of in-hospital MACE, based on ARC MI (component 2)"|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|All the subjects who met the study entry criteria, signed the written informed consent, were enrolled in the trial and in whom an attempt was made to cross the target lesion with the HT Progress or the HT Pilot guide wires, are included in the ITT population for the guide wire-related analysis.||percentage of participants||95% Confidence Interval|Number
691967|NCT01435031|Primary|Stent-related: Major Adverse Cardiac Events (MACE) (Per Protocol Set)|The primary stent-related endpoint is MACE, defined as death, MI, or clinically-driven TLR at 1 year post-procedure among all enrolled patients, for whom recanalization and pre-dilatation of the target lesion are completed and the study stent(s) (XIENCE V and/or XIENCE PRIME) is inserted into the coronary guiding catheter.|1 year|Per-protocol (PP) definition: The per-protocol population is defined as all ITT subjects in whom at least 1 study stent was implanted, met procedure success, had available follow up data (i.e. a MACE event within 360 days or follow up of at least 330 days), and did not have major protocol deviations due to inappropriate enrollment.||percentage of participants|||Number
691968|NCT01435031|Primary|Stent-related: Major Adverse Cardiac Events (MACE) (Per ITT Set)|The primary stent-related endpoint is MACE, defined as death, MI, or clinically-driven TLR at 1 year post-procedure among all enrolled patients, for whom recanalization and pre-dilatation of the target lesion are completed and the study stent(s) (XIENCE V and/or XIENCE PRIME) is inserted into the coronary guiding catheter.|1 year|Intention-to-treat (ITT) definition: ITT subjects include all subjects who met the study entry criteria, signed the written informed consent, were enrolled in the trial and whose target lesion was successfully crossed and predilated.||percentage of participants|||Number
691969|NCT01434823|Secondary|Duration of Rounds for Daytime Intensivist|This will be a secondary outcome of the Intensivist Sleep and Work sub-study.|Daily||||||
691970|NCT01434823|Secondary|Total Number of Calls Per Night for Daytime Intensivist|This will be a secondary outcome of the Intensivist Sleep and Work sub-study.|Daily||||||
691971|NCT01434823|Secondary|Daytime Intensivist Hours Worked Per Week (Inclusive of Home Call)|This will be a secondary outcome of the Intensivist Sleep and Work sub-study.|Weekly||||||
691972|NCT01434823|Secondary|Daytime Intensivist Hours Worked Per Week (Without Home Call)|This will be a secondary outcome of the Intensivist Sleep and Work sub-study.|Weekly||||||
691973|NCT01434823|Secondary|Daytime Intensivist False Starts (on Vigilance Testing)|This will be a secondary outcome of the Intensivist Sleep and Work sub-study.|Daily on Weekdays||||||
691974|NCT01434823|Secondary|Daytime Intensivist Lapses in Attention (on Vigilance Testing)|This will be a secondary outcome of the Intensivist Sleep and Work sub-study.|Daily on Weekdays||||||
691975|NCT01434823|Secondary|Reaction Time of Daytime Intensivists (on Vigilance Testing)|This will be a secondary outcome of the Intensivist Sleep and Work sub-study.|Daily on Weekdays||||||
691976|NCT01434823|Secondary|Maximal Uninterrupted Sleep Duration for Daytime Intensivists|This will be a secondary outcome of the Intensivist Sleep and Work sub-study.|Daily||||||
691977|NCT01434823|Secondary|Number of Interruptions Per Night for Daytime Intensivists|This will be a secondary outcome of the Intensivist Sleep and Work sub-study.|Daily||||||
691978|NCT01434823|Secondary|Daytime Intensivist Sleep Efficiency|This will be a secondary outcome of the Intensivist Sleep and Work sub-study.|Daily||||||
691979|NCT01434823|Secondary|Daytime Intensivist Daily Sleep Duration|This will be the primary outcome of the Intensivist Sleep and Work sub-study.|Daily||||||
691980|NCT01434823|Secondary|Discharge Home From Hospital|Patients who were discharged from the hospital to their homes|Assessed up to 12 months|||participants|||Number
691981|NCT01434823|Secondary|Re-admission to the MICU Within 48 Hours|The investigators will measure, in hours, the time spent from discharge from the MICU until a patient is re-admitted to the MICU during the same hospital stay.|From time of discharge from MICU, to re-admission to the MICU - assessed up to 12 months|||participants|||Number
691982|NCT01434823|Secondary|In-hospital Mortality|Mortality will be assessed during each patient's stay in the hospital.|From time of admission to MICU to hospital discharge - assessed up to 12 months|||participants|||Number
691983|NCT01434823|Secondary|MICU Mortality|Mortality will be assessed during each patient's stay in the MICU from admission to discharge|From time of admission to MICU until discharge from MICU - assessed up to 12 months|||participants|||Number
691984|NCT01434823|Primary|MICU Length of Stay|Time from ICU admission to discharge|From time of admission in the MICU until time of discharge from the MICU - assessed up to 12 months|||hours||Inter-Quartile Range|Median
691985|NCT01434693|Primary|Incidence of Adverse Events|Comparison of safety and tolerability was performed across the dose levels by evaluating the post-dose tolerability of TSO in patients with Crohn's Disease via incidence of adverse events (i.e. # events) with a specific focus on reported gastrointestinal signs and symptoms|6 mo|All patients who were randomized were treated according to the protocol and therefore were all included in the Safety Population.||events|||Number
691986|NCT01434680|Secondary|Number Of Subjects Reporting Solicited Local And Systemic Adverse Events|"Safety was assessed as the number of subjects who reported solicited local and systemic adverse events following a single injection with either MenC-CRM LIQ or MenC-CRM ROS or MenC-CRM EMV.
Safety was also assessed in subjects who mistakenly received MenC-CRM EMV instead of MenC-CRM ROS."|From day 1 through day 7|Analysis was done on the safety dataset, i.e. the subjects in the exposed population who provided postvaccination safety data.||Number of subjects|||Number
691987|NCT01434680|Secondary|Geometric Mean hSBA Titers Against N Meningitidis Serogroup C 28 Days After Vaccination|Immunogenicity was measured by hSBA GMTs against N meningitidis type C, approximately 28 days (at day 29) after a single vaccination when administered to toddlers to assess the equivalence of MenC-CRM LIQ to MenC-CRM ROS.|1 month postvaccination (day 29)|Analysis was done on the per protocol (PP) set.||Titers||95% Confidence Interval|Geometric Mean
691988|NCT01434680|Primary|Geometric Mean Human Serum Bactericidal Activity Titers Against N Meningitidis Serogroup C 28 Days After Vaccination|Immunogenicity was measured by human serum bactericidal activity (hSBA) geometric mean titers (GMTs)against N meningitidis type C, at day 29 after a single vaccination when administered to toddlers to assess the equivalence of MenC-CRM LIQ to MenC-CRM EMV and MenC-CRM ROS to MenC-CRM EMV.|1 month postvaccination (day 29)|Analysis was done on the per protocol (PP) set, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis.||Titers||95% Confidence Interval|Geometric Mean
691989|NCT01434654|Secondary|Cerebrospinal Fluid|To measure plateaux CSF ARV concentrations. This will identify the proportion of patients achieving levels of specific ARVs capable of inhibiting 95% of in vitro viral replication (IC95).|Baseline to 12 Months|Data presented for n=5 participants with detectable CSF ARV concentrations who had lumbar puncture at Baseline and 12 months. The pre-specified analysis was not conducted as nevirapine, raltegravir, and darunavir were the only ARVs detected in CSF, and of these, only nevirapine was detected above the minimum threshold (set at >50 ug/L).||ug/L||Standard Error|Mean
691990|NCT01434654|Secondary|Change in MRS Cerebral Metabolite Ratios in Frontal White Matter|Change in major cerebral metabolites in the frontal white matter, as measured by 1H-Magnetic Resonance Spectroscopy (MRS), between baseline and 12-months. Spectra were acquired on a Phillips Achieva 3T MRI scanner using point-resolved spectroscopy (PRESS) sequence with short TE. jMRUI/AMARES algorithm was used to process spectra. Metabolite ratios were calculated for the following metabolites: N-acetyl aspartate (NAA), choline (Cho), creatine (Cr), myo-inositol (mIo), glutamate/glutamine complex (Glx), in relation to internal H20 as standard.|Baseline and 12 months|n=1 participant in high CNS penetrance arm did not return for 12-months follow-up visit. Their baseline data were therefore excluded from analysis.||Ratio||Standard Error|Least Squares Mean
691991|NCT01434654|Secondary|Change in MRS Cerebral Metabolite Ratios in Basal Ganglia|Change in major cerebral metabolites in the basal ganglia, as measured by 1H-Magnetic Resonance Spectroscopy (MRS), after a 12 month period of observation. Spectra were acquired on a Phillips Achieva 3T MRI scanner using point-resolved spectroscopy (PRESS) sequence with short echo time (TE). jMRUI/AMARES algorithm was used to process spectra. Metabolite ratios were calculated for the following metabolites: N-acetyl aspartate (NAA), choline (Cho), creatine (Cr), myo-inositol (mIo), in relation to internal water (H20) as standard.|Baseline and 12 months|n=1 participant in high CNS penetrance arm did not return for 12-months follow-up visit. Their baseline data were therefore excluded from analysis.||Ratio||Standard Error|Least Squares Mean
691992|NCT01434654|Primary|Change in Neurocognitive Functioning|Change in overall neurocognitive performance, defined as a global neurocognitive z-score, after a 12-month period of observation, between HIV positive patients taking antiretroviral regimens categorized as being either of high or low CNS penetration. To derive this score, 1) raw scores obtained from a 5-domain brief neurocognitive battery were converted to age-corrected z-scores (M=0, Standard Deviation=1) and 2) the set of individual subtest z-scores were averaged to generate a single composite (global) z-score for each subject. Lower (negative) scores therefore indicate greater levels of cognitive impairment.|Change from baseline Neuropsychological testing at 6 and 12 months|Modified intent-to-treat analysis. All enrolled participants were included aside n=2 low CNS penetrance with baseline data only (1 lost to follow-up, 1 withdrew before 6-months).||Global neurocognitive z-score||Standard Error|Least Squares Mean
691993|NCT01434641|Secondary|Rest/Stress Myocardial Count Density Ratio|"The rest and stress myocardial count densities are determined automatically using Evolution software on the GE Healthcare Xeleris Nuclear Medicine computer workstation. The ratio is calculated by simple division.
Please not that patient outcomes are NOT measured in this research protocol."|immediately following SPECT image processing (1 hour after the test)||||||
692007|NCT01434511|Secondary|Proportion of Bleeding Episodes Responsive to OBI-1 Therapy at Designated Assessment Time Points After the Initiation of Therapy, as Assessed by the Investigator||Through 90 days ± 7days following final OBI-1 dose|This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).|||||
691994|NCT01434641|Primary|Myocardial Perfusion SPECT Image Quality 16 Minutes|"SPECT image quality realized using the stress/rest single-day protocol: 16- minute post-stress acquisitions If myocardial image quality is equivalent or superior to that encountered with standard myocardial perfusion SPECT performed using a standard low-dose rest/high-dose SPECT protocol and OSEM processing and if the rest/stress myocardial count density ratio is > 3.5 the outcome of a particular patient is judged to be favorable (acceptable).If either image quality is poor or if the rest/stress count density ratio is less than 3.5, the outcome is judged unfavorable."|at 16 minutes|Of the total 102 patients enrolled, additional 16-minute post-stress SPECT was performed on 37 patients.||participants|||Number
691995|NCT01434641|Primary|Myocardial Perfusion SPECT Image Quality 12 Minutes|"SPECT image quality realized using the stress/rest single-day protocol: 12- minute post-stress acquisitions If myocardial image quality is equivalent or superior to that encountered with standard myocardial perfusion SPECT performed using a standard low-dose rest/high-dose SPECT protocol and OSEM processing and if the rest/stress myocardial count density ratio is > 3.5 the outcome of a particular patient is judged to be favorable (acceptable).If either image quality is poor or if the rest/stress count density ratio is less than 3.5, the outcome is judged unfavorable."|at 12 minutes|||participants|||Number
691996|NCT01434511|Secondary|Anti-host Cell Protein Baby Hamster Kidney (BHK) Antibody Titer.||Through 90 days ± 7days following final OBI-1 dose|This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).|||||
691997|NCT01434511|Secondary|Anti-OBI-1 Antibody Titer.||Through 90 days ± 7days following final OBI-1 dose|This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).|||||
691998|NCT01434511|Secondary|Anti-human Factor VIII Antibody Titer.||Through 90 days ± 7days following final OBI-1 dose|This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).|||||
691999|NCT01434511|Secondary|Efficacy Assessment of OBI-1 in Participants With Anti-human Factor VIII Titers >30 Bethesda Units (BU)||Through 90 days ± 7days following final OBI-1 dose|This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).|||||
692000|NCT01434511|Secondary|Recovery and Elimination Rate Parameters of OBI-1 in Subjects With Inhibitors Treated With OBI-1 Therapy.||Through 90 days ± 7days following final OBI-1 dose|This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).|||||
692001|NCT01434511|Secondary|Correlation Between the Pre-infusion Anti-OBI-1 Antibody Titers and the Recovery of OBI-1.||Through 90 days ± 7days following final OBI-1 dose|This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).|||||
692002|NCT01434511|Secondary|Correlation Between the Pre-infusion Anti-OBI-1 Antibody Titers, the Total Dose of OBI-1, the Outcome at 24 Hours and the Eventual Control of the Bleeding Episode.||Frame: Through 90 days ± 7days following final OBI-1 dose|This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).|||||
692003|NCT01434511|Secondary|Correlation Between Response to OBI-1 Therapy at Specified Time Points and Eventual Control of Serious Bleeding Episodes.||Through 90 days ± 7days following final OBI-1 dose|This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).|||||
692004|NCT01434511|Secondary|Total Number of Infusions of OBI-1 Required to Successfully Control Qualifying Bleeding Episodes.||Through 90 days ± 7days following final OBI-1 dose|This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).|||||
692005|NCT01434511|Secondary|Total Dose of OBI-1 Required to Successfully Control Qualifying Bleeding Episodes.||Through 90 days ± 7days following final OBI-1 dose|This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).|||||
692006|NCT01434511|Secondary|Frequency of Infusions of OBI-1 Required to Successfully Control Qualifying Bleeding Episodes.||Through 90 days ± 7days following final OBI-1 dose|This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).|||||
692308|NCT01430754|Secondary|Change From Run-In in Subjective Nighttime Total Sleep Time in Lower Quartile of Days (LQ-nTST) During the Randomized Phase|LQ-nTST measures the average nighttime sleep during the patient's worst 25% of nights (shortest total nighttime sleep) from run-in and randomized phase. The higher number indicates improvement.|Approximately 12 weeks|||minutes||Standard Error|Mean
692008|NCT01434511|Secondary|Overall Proportion of Serious Bleeding Episodes Successfully Controlled With OBI-1 Therapy, as Assessed by the Investigator.||Through 90 days ± 7days following final OBI-1 dose|This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).|||||
692009|NCT01434511|Primary|Proportion of Serious Bleeding Episodes Responsive to OBI-1|This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, the study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within the OBI-1-302 study (Congenital Hemophilia A).|24 hours after initiation of treatment|This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).|||||
692010|NCT01434342|Primary|Adherence|Adherence is measured by the percentage of randomized participants who have a Quitline call. Note that this outcome is only defined for the Intervention arm|24 weeks|All randomized participants||Participants|||Count of Participants
692011|NCT01434342|Primary|Feasibility of a Smoking Cessation Intervention Among Cancer Patients|The primary feasibility measures are retention and adherence. This outcome, retention, is the percentage of patient who remain in the study for 24 weeks.|24 Weeks|All randomized participants||Participants|||Count of Participants
692012|NCT01434186|Primary|Mean Change in HbA1c From Baseline to Week 16||16 week short term treatment period|||percentage||Standard Deviation|Mean
692013|NCT01434121|Secondary|Plasma Cytokine/Chemokine Levels||during time of infusions - 96 hours from time of enrollment||||||
692014|NCT01434121|Secondary|Multiple Organ Dysfunction Score||during time of infusion - 96 hours from time of enrollment||||||
692015|NCT01434121|Secondary|Length of Time on Vasopressor Medication||during time of infusion - 96 hours from time of enrollment||||||
692016|NCT01434121|Secondary|Ventilator-free Days||subject will be followed until discharged from the hospital, has deceased, or study duration has reached 28 days from time of enrollment, whichever is first||||||
692017|NCT01434121|Secondary|Duration of Mechanical Ventilation||subject will be followed until mechanical ventilation has been discontinued, the subject has deceased, or study duration has reached 28 days from time of enrollment, whichever is first||||||
692018|NCT01434121|Secondary|Intensive Care Unit Length of Stay||subject will be followed until discharged from the ICU, has deceased, or study duration has reached 28 days from time of enrollment, whichever is first||||||
692019|NCT01434121|Primary|Number of Patients Who Experienced Ascorbic Acid Infusion Related Arterial Hypotension, Vomiting, or Tachycardia in Septic Patients|There were no instances of arterial hypotension, vomiting, or tachycardia within the study population related to the study drug|during time of infusion- 96 hours from time of enrollment|||participants|||Number
692020|NCT01434030|Secondary|Willingness to Follow PGASystem Advice|The categories below indicate types of information that could be received from a PGASystem and the percentage of participants who stated that they would follow this type of advice from a PGASystem.|2 hour focus group|||percentage of participants|||Number
692021|NCT01434030|Primary|Desire to Receive Advice From Personal Glucose Advisory System (PGASystem)|The categories below indicate types of information that could be received from a PGASystem and the percentage of participants who stated that they would like to receive this type of information from a PGASystem.|2 hour focus group|||percentage of participants|||Number
692022|NCT01433913|Secondary|Comparison of Changes in Serum PSA, Fasting Glucose, Fasting Insulin, IGF-1/IGFBP-3, Testosterone, and SHBG Between Study Groups as Assessed by Liquid Chromatography-tandem Mass Spectrometry Assay|Changes in a serum biomarker (from baseline to post-intervention) and secondary tissue endpoints will be compared between intervention groups using a t-test. If the distributions are not normally distributed, a non-parametric rank-sum test will be utilized. Correlations among the biomarkers and between postintervention metformin levels and changes in biomarker levels, will be explored (using Pearson or Spearman Rank correlation coefficients). Plasma levels of metformin will also be compared between groups using a t-test and the correlation of plasma and prostate tissue levels will be examined.|Baseline and 12 weeks||||||
692023|NCT01433913|Secondary|Comparison of Apoptosis (Cleaved Caspase 3), Angiogenesis (CD34), AMPK Activation (p-AMPK), mTOR Regulation (p-p70S6K), Cell Cycle Regulation (Cyclin D1and p-pRb) in the Prostatectomy Tissue Between Study Groups as Assessed by IHC|Changes in a serum biomarker (from baseline to post-intervention) and secondary tissue endpoints will be compared between intervention groups using a t-test. If the distributions are not normally distributed, a non-parametric rank-sum test will be utilized. Correlations among the biomarkers and between postintervention metformin levels and changes in biomarker levels, will be explored (using Pearson or Spearman Rank correlation coefficients). Plasma levels of metformin will also be compared between groups using a t-test and the correlation of plasma and prostate tissue levels will be examined.|12 weeks||||||
692024|NCT01433913|Secondary|Prostate Tissue Metformin Concentration Levels as Assessed by Liquid Chromatography Tandem Mass Spectrometry|Descriptive statistics will be performed on prostate tissue metformin concentrations within each intervention group. Little if any metformin is expected in the placebo group. Data between the two study groups will be compared using a two-group t-test at a two-sided 0.05 level of significance. The means (and 95% confidence intervals) and distribution of actual values will be reported. Linear regression will be performed to the post-intervention metformin concentration levels to adjust for demographics and duration on intervention. Logistic regression will also be performed.|12 weeks||||||
692025|NCT01433913|Primary|Cell Proliferation in the Prostatectomy Tissue as Assessed by Ki67 Expression Using Immunohistochemistry (IHC)|Data between the two study groups will be compared using a two-group t-test at a two-sided 0.05 level of significance. If the data are not normally distributed, a non-parametric rank-sum test will be utilized.|12 weeks|Participants with tissue sections available from prostatectomy||% positively stained nuclei||Standard Deviation|Mean
692606|NCT01426438|Secondary|Change in Triglycerides|Change in Triglycerides (mg/dL) from week 0 to week 24.|0 and 24 weeks|This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.||mg/dL||Inter-Quartile Range|Median
692026|NCT01433731|Primary|Percentage of Patients With Complete or Partial Response as Measured by Change in Lesion Severity Using CAILS (Composite Assessment of Index Lesion Severity)|Response assessed by change in lesion severity using Composite Assessment of Index Lesion Severity (CAILS) Assessment Tool which measures clinical signs of CTCL by erythema; scaling; plaque elevation; hypo- or hyperpigmentation, each on a scale of 0-8; and lesion size (cm2), on a scale of 0 (no lesion; 0 cm2) to 18 (300 cm2). Up to five index lesions are each scored, and a subtotal CAILS score is provided for each index lesion. A total score is calculated by summing these subtotals. Response criteria measure the change in CAILS score from baseline to follow-up as follows: Complete Response (CR): 100% decrease in CAILS score; Partial Response (PR): 50% – 99% decrease in CAILS score; Stable Disease (SD): < 25% increase to < 50% decrease in CAILS score; Progressive Disease (PD) ≥ 25% increase in CAILS score.|Weekly through day 28 (days 1, 7, 14, 21, 28) and again day 42|||percentage of participants|||Number
692027|NCT01433549|Secondary|Mean Non-Invasive Tear Film Break-Up Time (NITBUT)|As assessed by the investigator using a corneal topographer. NITBUT was assessed at the end of each 12-hour (approximate) cycle. During each cycle, contact lenses were worn for 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes. A new pair of contact lenses was dispensed for each 2-hour interval of lens wear. A longer tear film break-up time indicates a more stable tear film and may lead to a more comfortable lens-wearing experience.|Hour 12|All participants who participated in both phases of the study.||Seconds||Standard Deviation|Mean
692028|NCT01433549|Primary|Mean End-of-Day Comfort|As assessed by the participant using a visual analog scale ranging from 0 (extremely uncomfortable) to 100 (very comfortable and fresh) at the end of each 12-hour (approximate) cycle. During each cycle, contact lenses were worn for 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes. A new pair of contact lenses was dispensed for each 2-hour interval of lens wear.|Hour 12|All participants who participated in both phases of the study.||Units on a scale||Standard Deviation|Mean
692029|NCT01433471|Secondary|Change From Baseline of the Simple Clinical Colitis Activity Index at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 Weeks|To assess ulcerative colitis disease activity without requiring endoscopy|Baseline, 2, 4, 6, 8, 10, 14, 16, 18, 20, 22 weeks|Because of the small sample size of this study, investigators decided it was not possible to draw meaningful conclusions from the outcome measures and outcome measures were not collected or analyzed as originally planned. Therefore, no outcome measure data is available.|||||
692030|NCT01433471|Secondary|Change in Mayo Score From Baseline at 12 Weeks and 24 Weeks|To assess ulcerative colitis disease activity|Baseline, 12 weeks, 24 weeks|Because of the small sample size of this study, investigators decided it was not possible to draw meaningful conclusions from the outcome measures and outcome measures were not collected or analyzed as originally planned. Therefore, no outcome measure data is available.|||||
692031|NCT01433471|Primary|Change From Baseline of Gene Expression at 12 Weeks and 24 Weeks as Assessed by Microarray and Real-time Polymerase Chain Reaction Analysis of Pinch Biopsies||Baseline, 12 weeks, 24 weeks|Because of the small sample size of this study, investigators decided it was not possible to draw meaningful conclusions from the outcome measures and outcome measures were not collected or analyzed as originally planned. Therefore, no outcome measure data is available.|||||
692032|NCT01433471|Primary|Change From Baseline of Bacterial Composition and Attachment at 12 Weeks and 24 Weeks as Assessed by Real-time Polymerase Chain Reaction and 454 Sequencing of Pinch Biopsies and Stool Specimens||Baseline, 12 weeks, 24 weeks|Because of the small sample size of this study, investigators decided it was not possible to draw meaningful conclusions from the outcome measures and outcome measures were not collected or analyzed as originally planned. Therefore, no outcome measure data is available.|||||
692033|NCT01433471|Primary|Change From Baseline of Effector Lymphocyte Populations (Th1, Th2, Th17, and T-regulatory Cells) at 12 and 24 Weeks as Assessed by Flow Cytometry of Peripheral Blood Mononuclear Cells and Isolated Leukocytes From Pinch Biopsies||Baseline, 12 weeks, 24 weeks|Because of the small sample size of this study, investigators decided it was not possible to draw meaningful conclusions from the outcome measures and outcome measures were not collected or analyzed as originally planned. Therefore, no outcome measure data is available.|||||
692034|NCT01433471|Primary|Change From Baseline of Mucus Production at 12 Weeks and 24 Weeks as Assessed by Histopathology||Baseline, 12 weeks, 24 weeks|Because of the small sample size of this study, investigators decided it was not possible to draw meaningful conclusions from the outcome measures and outcome measures were not collected or analyzed as originally planned. Therefore, no outcome measure data is available.|||||
692035|NCT01433354|Primary|Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)|"Adverse events were summarized for the open-label treatment period, where the open-label treatment period is defined based on how AEs were collected and reported according to the manner in which participants entered the current study and which treatment (AFQ056 or placebo) they were receiving in the previous study.
AEs which were continuing from the core study or that started after the end of core study but prior to first dose of open-label study medication in the extension study for Category 1 participants are shown under ‘Prior to Ext. first dose’.
AEs which started during the open-label treatment period are presented based on the last AFQ056 dose taken on or before the onset date of the AE (25 mg bid; 50 mg bid; 75 mg bid; or 100 mg bid). No efficacy data presented as study was terminated."|Prior to first dose in extension study, Baseline (start of study treatment in extension study) to End of trial|The analysis was performed in the safety set (SS) population, defined as participants who received at least one dose of study medication and had at least one safety assessment occurring after first dose of extension study medication. Here, ‘Number of Participants Analyzed’ signifies those participants who were evaluable for this outcome measure.||participants|||Number
692036|NCT01433263|Secondary|Percentage Change From Baseline of Physical Activity Levels (Using the ActivPAL™ Device) Time Stepping Compared to Placebo at Week 4 and 7|Each patient was required to wear the ActivPal™ for a span of 6 days at Week 4 and Week 7 for patient home activity recording. The ActivPal™ was given to patients in clinic to wear for 6 consecutive days. The ActivPAL™ records periods spent sitting, standing and walking, sit-to-stand transitions, step count and rate of stepping (cadence) over a maximum period of 10 days with a fully charged new battery.|Baseline, Week 4 and Week 7|Pharmacodynamics (PD) analysis set: Patients with evaluable PD parameter data.||percentage change in time (minutes)||Standard Deviation|Mean
699284|NCT00002540|Secondary|T3 PSA Screening Results|Prostate-Specific Antigen (PSA) result|T3 (three years after entry)|All males in the Prostate Screening arm who had a PSA screen at T3 were analyzed.||Participants|||Number
692037|NCT01433263|Secondary|Percentage Change From Baseline of Physical Activity Levels (Using the ActivPAL™ Device) Time Standing Compared to Placebo at Week 4 and 7|Each patient was required to wear the ActivPal™ for a span of 6 days at Week 4 and Week 7 for patient home activity recording. The ActivPal™ was given to patients in clinic to wear for 6 consecutive days. The ActivPAL™ records periods spent sitting, standing and walking, sit-to-stand transitions, step count and rate of stepping (cadence) over a maximum period of 10 days with a fully charged new battery.|Baseline, Week 4 and Week 7|Pharmacodynamics (PD) analysis set: Patients with evaluable PD parameter data.||percentage change in time (minutes)||Standard Deviation|Mean
692038|NCT01433263|Secondary|Percentage Change From Baseline of Physical Activity Levels (Using the ActivPAL™ Device) Time Sedentary Taken Compared to Placebo at Week 4 and 7|Each patient was required to wear the ActivPal™ for a span of 6 days at Week 4 and Week 7 for patient home activity recording. The ActivPal™ was given to patients in clinic to wear for 6 consecutive days. The ActivPAL™ records periods spent sitting, standing and walking, sit-to-stand transitions, step count and rate of stepping (cadence) over a maximum period of 10 days with a fully charged new battery.|Baseline, Week 4 and Week 7|Pharmacodynamics (PD) analysis set: Patients with evaluable PD parameter data.||percentage change in time (minutes)||Standard Deviation|Mean
692039|NCT01433263|Secondary|Percentage Change From Baseline of Physical Activity Levels (Using the ActivPAL™ Device) Number of Steps Taken Compared to Placebo at Week 4 and 7|Each patient was required to wear the ActivPal™ for a span of 6 days at Week 4 and Week 7 for patient home activity recording. The ActivPal™ was given to patients in clinic to wear for 6 consecutive days. The ActivPAL™ records periods spent sitting, standing and walking, sit-to-stand transitions, step count and rate of stepping (cadence) over a maximum period of 10 days with a fully charged new battery.|Baseline, Week 4 and Week 7|Pharmacodynamics (PD) analysis set: Patients with evaluable PD parameter data.||percentage change in number of steps||Standard Deviation|Mean
692040|NCT01433263|Secondary|Percentage Change From Baseline of Bone Mineral Density (BMD) by Dual-Energy X-ray Absorptiometery (DXA) Compared to Placebo at Week 8|Bone Mineral Density (BMD)is measured by dual energy x-ray absorptiometry (DXA).Percent Change = [(BMD at Visit - BMD at Baseline) / BMD at Baseline] * 100.|Baseline, Week 8|Pharmacodynamics (PD) analysis set: Patients with evaluable PD parameter data. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. week 8||Percentage Change in BMD||Standard Deviation|Mean
692041|NCT01433263|Secondary|Percentage Change From Baseline in Total Lean Body Mass (LBM) by Dual-Energy X-ray Absorptiometery (DXA) Compared to Placebo: at Week 8|total lean body mass (LBM) is measured by dual energy x-ray absorptiometry (DXA).Percent Change = [(LBM at Visit - LBM at Baseline) / LBM at Baseline] * 100.|Baseline, Week 8|Pharmacodynamics (PD) analysis set: Patients with evaluable PD parameter data. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. week 8||Percentage Change in LBM||Standard Deviation|Mean
692042|NCT01433263|Secondary|Time to Reach the Maximum Concentration After Drug Administration (Tmax)|Blood samples for pharmacokinetic (PK) evaluation were drawn on Day 1 30mg/kg BYM338 (Core)or week 8 Late 30mg/kg BYM338 (when placebo subjects were rolled over to active). Tmax was directly determined from the raw serum concentration-time data.|0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Day 1 and Week 8|Pharmacokinetics (PK) analysis set: Patients with evaluable PK data.||hr||Inter-Quartile Range|Median
692043|NCT01433263|Secondary|Maximum Observed Serum Concentration (Cmax)|Blood samples for pharmacokinetic (PK) evaluation were drawn on Day 1 30mg/kg BYM338 (Core)or week 8 Late 30mg/kg BYM338 (when placebo subjects were rolled over to active). PK parameters were calculated from plasma concentration-time data using non-compartmental methods.|0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Day 1 and Week 8|Pharmacokinetics (PK) analysis set: Patients with evaluable PK data.||ng/ml||Standard Deviation|Mean
692044|NCT01433263|Secondary|Percentage Change in Body Weight From Baseline at Week 7 and Week 9|Percentage Change in body weight from baseline in killograms (kg) at week 7 and week 9|Baseline, Week 7 and Week 9|Pharmacodynamics (PD) analysis set: Patients with evaluable PD parameter data.||Percent Change of Weight (kg)||Standard Deviation|Mean
692045|NCT01433263|Primary|Percentage Change From Baseline of Thigh Muscle Volume (TMV) by MRI Scan at Week 8|Thigh Muscle Volume (TMV) change was evaluated by a responder analysis. Patients whose loss of muscle TMV by MRI was no more than or equal to 2% at Week 8 was considered responders.|Baseline, week 8|Pharmacodynamics (PD) analysis set: Patients with evaluable PD parameter data. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. week 8||Percentage Change of TMV||Standard Deviation|Mean
692046|NCT01433250|Secondary|Measure of Disability: Expanded Disability Status Scale (EDSS).|The EDSS is a scale for assessing neurological impairment in MS (Kurtzke 1983) including (1) a series of scores in each of eight functional systems, and (2) the EDSS steps (ranging from 0 (normal) to 10 (death due to MS). The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions.|Baseline to week 97|Not all patients may have been available at all time points for EDSS evaluation||participants|||Number
692047|NCT01433250|Secondary|Change in Brain Volume at End of Study.|Change in volume from start to end of study|week 97|||ml||Standard Deviation|Mean
692048|NCT01433250|Secondary|Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T2 Weighted MRI|Measures of absolute number of gadolinium [Gd]-enhancing lesions on T2-weighted lesions|weeks 13,25,37,53,73 and 97|||lesions||Full Range|Mean
692049|NCT01433250|Secondary|Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T1 Weighted MRI|Measures of absolute number of gadolinium [Gd]-enhancing lesions on T1-weighted scans|weeks 13,25,37,53,73 and 97|||lesions||Full Range|Mean
692050|NCT01433250|Secondary|Distribution of Patients With Relapses to End of Study (EOS) (All Subjects)|Description: number of relapses based on neurological assessments and EDSS|week 97|||Participants|||Number
692051|NCT01433250|Primary|Measure: Number of Subjects With Adverse Events, Number of Abnormalities in Safety Assessments|Safety outcomes will be described in Adverse events section as there was not an efficacy primary outcome|97 weeks|||participants|||Number
692317|NCT01430624|Secondary|PTSD Symptom Scale Self-Report (PSS-SR)|Total scores range from 0 to 51 with higher scores indicating greater frequency of symptoms, Measure of PTSD symptoms.|2 weeks prior to 6 week, 3 month, 6 month followup|Only includes those with complete scale score information||units on a scale||Standard Deviation|Mean
692052|NCT01433172|Secondary|Response Rate|Response according to Response Evaluation in Solid Tumors (RECIST) 1.1. Complete Response (CR): Complete disappearance of all measurable and non-measurable disease; No new lesions. Partial Response (PR): Applies only to patients with at least one measurable lesion; Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. Progressive Disease (PD): 20% or greater increase in the sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline. Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided). Appearance of any new lesion/site. Stable Disease (SD): Does not qualify for CR, PR, Progression or Symptomatic Deterioration; All target measurable lesions must be assessed using the same techniques as baseline.|Up to 12 Months|All Phase II participants||Participants|||Count of Participants
692053|NCT01433172|Primary|Phase II: Progression Free Survival (PFS)|PFS is measured as the time from start of treatment to progression or death. 6 month progression free survival will be estimated from available clinical and radiographic assessments and RECIST 1.1 will be used to make tumor measurements. Progressive Disease (PD) = 20% increase in the sum of the longest diameter of target lesions.|Up to 6 Months|A Phase II participants evaluable at time of analysis.||months||95% Confidence Interval|Median
692054|NCT01433172|Primary|Phase I: Recommend Phase II Dose (RPDII)|Highest dose level of GMCD40L vaccine in combination with CCL21 that induced dose limiting toxicity (DLT) in fewer than 33% of patients. DLT: Intervention-specific acute toxicity; i.e., occurrence within 28 days of drug administration, according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE), V 4: 1.) that precludes further dose escalation. Participants are entered in cohorts of 3 at the first dose level. Doses are not escalated over the course of treatment of an individual patient. If 2 or more patients experience toxicity in dose level 1 (30X10^6 cells per injection), dose de-escalation will occur. Dose level -1 will be defined by 10 % reduction of cells administered from dose level 1 and follow the same rules. It is not feasible to escalate the dose of the vaccine beyond 30X10^6 cells per injection; therefore the Maximum Tolerated Dose (MTD) may not be reached in this study. In that case, the highest dose level will be used in the phase II component.|Up to 6 Months|All Phase I Participants||Recommend Phase II Dose Level|||Number
692055|NCT01433159|Primary|Change From Baseline in Composite PUSH (Pressure Ulcer Scale for Healing) Score|"Change from baseline in composite wound bed scores measured as the PUSH total score on Day 15. The PUSH Tool v.3.0, which monitors the three critical parameters that are the most indicative of healing, was used in this study. Scales for the three measurements were: Area = 0 (healthy skin) to 10 (>24 cm x cm); Exudate = 0 (non) to 3 (heavy); Tissue type = 0 (epithelial tissue) to 4 (necrotic tissue). All values were summed and final values are the cumulative scores.
Cumulative Scores = 0 (Best possible outcome: healthy skin/epithelial tissue with no exudate) to 17 (Worst possible outcome: wound >24 cm x cm, containing necrotic tissue, with heavy exudate)"|baseline, 14 Days|Per Protocol Population||scores on a scale||Standard Deviation|Least Squares Mean
692056|NCT01433107|Secondary|Number of Subjects With Adverse Event|Number of Subjects with adverse event|6 weeks|Number of subject with any adverse events mild or moderate having signed the informed consent. One subject had an adverse event but did not receive any study drug and was not included in the number of subjects started.||participants|||Number
692057|NCT01433107|Secondary|Total Clinical Signs and Symptoms (S/S) Scores|"Each clinical sign or symptom will be assessed separately. The investigator will evaluate the severity of each sign or symptom over the entire target foot. Clinical signs and symptoms including desquamation (scaling), erythema, incrustation (crusting), pustules, vesiculation and pruritus will be evaluated by the investigator or designee and recorded at every visit using the following scale:
0 = absent
= mild
= moderate
= severe In order to calculate the total symptom score, the scores for each individual symptom are added up.
Possible range : 0 to 18"|week 6|||units on a scale||95% Confidence Interval|Mean
692058|NCT01433107|Primary|Effective Treatment Outcome (Direct Microscopy and Culture Negative and Total Signs and Symptom Score Less or Equal to 2)|"Each clinical sign or symptom will be assessed separately. The investigator will evaluate the severity of each sign or symptom over the entire target foot. Clinical signs and symptoms including desquamation (scaling), erythema, incrustation (crusting), pustules, vesiculation and pruritus will be evaluated by the investigator or designee and recorded at every visit using the following scale:
0 = absent
= mild
= moderate
= severe In order to calculate the total symptoms score the rating for all symptoms are added up.
Possible range 0 to 18"|week 6|Number of success. The discrepancy between number of participants analyzed and participants completed is explained by delayed exclusions (people having negative mycology results received after completion of the study).||participants|||Number
692059|NCT01433081|Secondary|Opioid Consumption|Opioid consumption after discharge|24 hours|||miligram morphine equivalents||Inter-Quartile Range|Median
692060|NCT01433081|Primary|Quality of Recovery Scores Post Operative|Quality of recovery scores post operative. Scored on a scale of 40 (poor recovery) to 200 (good recovery).|24 hours post operative|Two drop outs for either arm were removed from analysis.||units on scale 40 (low) - 200 (high)||Inter-Quartile Range|Mean
692061|NCT01433055|Secondary|The Effect of Adjunct Minocycline to Placebo on Global Clinical Improvement of Symptoms.|The Clinical Global Impression Severity score will be used to examine the effect of minocycline compared to placebo. This assessment has 2 items (scored 0-7) with a total minimum socre of 0 and maximum score of 14. The lower the score the better the outcome.|10 Weeks|||units on a scale||Standard Deviation|Mean
692062|NCT01433055|Secondary|The Effect of Adjunct Minocycline to Placebo to Improve Depressive Symptoms as Measured by the Calgary Depression Scale|The total score of the Calgary Depression Rating Scale will be used to examine the efficacy of minocycline compared to placebo in improving depressive symptoms. This assessment has 9 items (scored 0-3) with a total minimum socre of 0 and maximum score of 27. The lower the score the better the outcome.|10 Weeks|||units on a scale||Standard Deviation|Mean
692063|NCT01433055|Secondary|The Effect of Minocycline Compared to Placebo to Improve Negative Symptoms as Measured by the Scale for the Assessment of Negative Symptoms (SANS)|Adjunct minocycline will be compared to placebo to test its efficacy in improving negative symptoms of schizophrenia. The Scale for the Assessment of Negative Symptoms (SANS) will be used to test changes in the total SANS score in adjunct minocycline compared to placebo in the 10 week study. This assessment has 22 items (scored 0-5) with a total minimum score of 0 and maximum score of 110. The lower the score the better the outcome.|10 Weeks|||units on a scale||Standard Deviation|Mean
692064|NCT01433055|Primary|Effect of Minocycline on Cognitive Symptoms as Measured by the MATRICS Consensus Cognitive Battery.|Adjunct minocycline will be compared to placebo to test its efficacy in improving cognitive function. Neuropsychological testing will be done at baseline and endpoint using the MATRICS battery. A composite score as well as individual scores will be will be the primary outcome over the 10 week randomized study. This assessment total minimum score of -10 and maximum score of 80. He higher the score the better the outcome.|10 Weeks|||units on a scale||Standard Deviation|Mean
692065|NCT01433055|Primary|Brief Psychiatric Rating Scale (BPRS) Positive Symptom Domain Scores Between Minocycline and Placebo.|Adjunct minocycline to clozapine will be compared to placebo to test its efficacy to improve positive psychotic symptoms. The 4 item positive sub factor of the Brief Psychiatric Rating Scale (BPRS) will be the primary outcome over the 10 week randomized study. Total maximum score is 28, and total minimum score is 4. The positive domain score consists of conceptual disorganization (item 4), suspiciousness (item 11) hallucinatory behavior (item 12), and unusual thought content (item 15). All data is reported as the difference between baseline and 10 weeks. The lower the score the better the outcome.|10 Weeks|The BPRS is a scale that measures major psychotic and non psychotic symptoms in persons with psychotic disorders. It is an 4 item scale with a score range of 1-7 on each item. Results are reported as total score. Total maximum score is 28, and total minimum score is 4.||units on a scale||Standard Deviation|Mean
692066|NCT01433042|Primary|Precentage of SB3 Images That Were Graded as Superior in Image Quality to SB2 by the Physicians|precentage of SB3 images that were graded as superior in image quality to SB2 by the physicians|up to 6 months from end of recruitment|"Five (2%) cases were excluded from the efficacy analysis due to the following :
1 patient withdrawn prior to any procedure.
1 patient did not meet the inclusion criteria
3 cases, the capsule remained in the stomach during the entire procedure.
Therefore, 220 cases are included in the efficacy analysis."||percentage of cases|||Number
692067|NCT01433016|Primary|PDR Peak|PDR peak - the rate at which the 13C labeled substrate is metabolized, percentage dose recovery.|At study day one after one hour|||percentage of dose recovery||Standard Deviation|Mean
692068|NCT01432938|Secondary|Pharmacodynamics: Maximum Observed International Normalized Ratio (INRmax) of Warfarin|Observed INRmax was assessed from venous blood samples collected to determine the response variable INR at predose and at pre-determined intervals after the administration of warfarin.|Predose (warfarin) and up to 144 hours postdose on Day 1 for Treatment 1 (warfarin alone) and on Day 3 for Treatment 2 (warfarin in combination with dulaglutide)|Participants who received at least 1 dose of warfarin with evaluable warfarin INR data.||ratio||Geometric Coefficient of Variation|Geometric Mean
692069|NCT01432938|Secondary|Pharmacodynamics: Area Under the International Normalized Ratio Curve (AUCINR) of Warfarin|AUCINR was assessed from venous blood samples collected to determine the response variable INR at predose and at pre-determined intervals after the administration of warfarin.|Predose (warfarin) and up to 144 hours postdose on Day 1 for Treatment 1 (warfarin alone) and on Day 3 for Treatment 2 (warfarin in combination with dulaglutide)|Participants who received at least one dose of warfarin with evaluable warfarin INR data.||ratio||Geometric Coefficient of Variation|Geometric Mean
692070|NCT01432938|Primary|Pharmacokinetics: Time to Maximum Concentration (Tmax) of R-warfarin and S-warfarin||Predose (warfarin) and up to 144 hours postdose on Day 1 for Treatment 1 (warfarin alone) and on Day 3 for Treatment 2 (warfarin in combination with dulaglutide)|Participants who received at least one dose of warfarin with evaluable warfarin concentration data.||hours||Full Range|Median
692071|NCT01432938|Primary|Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of R-warfarin and S-warfarin||Predose (warfarin) and up to 144 hours postdose on Day 1 for Treatment 1 (warfarin alone) and on Day 3 for Treatment 2 (warfarin in combination with dulaglutide)|Participants who received at least one dose of warfarin with evaluable warfarin concentration data.||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
692072|NCT01432938|Primary|Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of R-warfarin and S-warfarin|Area under the concentration versus time curve (AUC) from zero to infinity was determined from plasma concentrations of the S- and R- enantiomers of warfarin.|Predose (warfarin) and up to 144 hours postdose on Day 1 for Treatment 1 (warfarin alone) and on Day 3 for Treatment 2 (warfarin in combination with dulaglutide)|Participants who received at least one dose of warfarin with evaluable warfarin concentration data.||nanograms times hours per milliliter||Geometric Coefficient of Variation|Geometric Mean
692073|NCT01432886|Primary|Number of Participants With Adverse Events|The number of subjects who developed 'treatment-emergent adverse events (AEs) and serious adverse events (SAEs) were evaluated.|From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years|The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation.||Participants|||Number
692074|NCT01432886|Primary|Number of Participants With Dose Limiting Toxicity (DLT)|For DLT evaluation, severity (grade) was classified according to common terminology criteria for adverse events version 4.0 (CTCAE v4.0). DLTs were defined as grade 4 neutropenia persisting for more than 7 days; grade 3 or above febrile neutropenia; grade 4 thrombocytopenia or grade 3 thrombocytopenia requiring blood transfusion; non-hematologic toxicity (excluding toxicity related to neutrophils, leukocytes, lymphocytes, platelets, CD4 lymphocytes, anemia, and bone marrow density) greater than or equal to grade 3 (Exceptions: Dose reduction was not required even when the following conditions were met: grade 3 nausea, vomiting, or diarrhea controllable with anti-emetic or anti-diarrheal medication and abnormal laboratory parameter not requiring treatment); and day 8 administration was delayed or skipped as a result of the subject did not meet the dosing riteria within cycle.|Up to 3 weeks|The DLT analysis set included those participants who received at least one dose of study drug and had a DLT assessment in cycle 1 (3 weeks) without deviations from the eribulin mesylate/trastuzumab dosing regimens and other major protocol prescripts. Participants with a DLT, regardless of this criterion, were also included in the DLT analysis set.||Participants|||Number
692086|NCT01432561|Primary|Cysteamine Absorption: Area Under the Plasma Concentration Curve (AUC)|Subjects were randomized to one of two possible treatment sequences using block randomization: Sequence 1 - fasted, high-fat, high-protein or Sequence 2 - high-protein, high-fat, fasted. Sequence assignment determined the treatment condition corresponding to Period I, II & III visits.|0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180 minutes, and 3.5, 4, 4.5, 5, 6 hours post‐dose|||min*uM||Standard Deviation|Mean
738605|NCT00450749|Secondary|Lymphocyte Oxidative DNA Damage Capacity as Measured by Comet Assay||At baseline and at 4-7 weeks||||||
692075|NCT01432756|Primary|Number of Topics Discussed Between Parent and Child|"Measured using the Parent-Child Communication Scale (communication on sexual and HIV topics that the intervention covers) for both parent and child participants in pre- and post-assessments. This is a measurement of the number of sex and HIV topics discussed. 16 topics were assessed, including how women get pregnant, how to use condoms to prevent pregnancy and HIV, and how to recognize sexual pressure.
For each topic, participants answered yes or no if they discussed it, and then rate between 1-16 to indicate their communication (higher scores mean better communication). The total scores is reported as the sum of the 16 items, and can range from 0-16."|6 months|Each dyad consisted of one parent and their adolescent child. Sixty-six parents and 66 adolescents participated.||number of sex and HIV topics discussed||Standard Deviation|Mean
692076|NCT01432626|Primary|Number of Participants Who Had an Abnormal Regional Uptake of I-123 mIBG at Baseline (Acute Phase) and the Number of Participants Who Had an Abnormal I-123 mIBG Uptake on Follow up (Recovery Phase)|Number of participants who had an abnormal regional uptake of I-123 mIBG at baseline (acute phase) and the number of participants who had an abnormal I-123 mIBG uptake on follow up (recovery phase)|During the acute phase (2-5 days with an expected mean 3 days) and after recovery of cardiac function (6 weeks)|||participants|||Number
692077|NCT01432600|Secondary|Phase II - Occurrence of Possibly Related Adverse Events (AEs)|Phase II: Participants with Grade 3 or 4 adverse events at least possibly related to the study treatment in 5% of participants in the Phase 2 portion, by AE category, assessed by the National Cancer Institute Common Terminology Criteria (NCI CTC) version 4.0.|Up to 48 Months|All Phase II Participants who completed allocated intervention.||percentage of participants|||Number
692078|NCT01432600|Secondary|Phase II - Median Overall Survival (OS)|Overall survival per treatment arm. Overall survival is defined as the time from start of treatment to death of any cause.|36 Months|All participants assigned to Arm B and Arm C.||months||95% Confidence Interval|Median
692079|NCT01432600|Secondary|Phase II - Median Progression Free Survival (PFS)|Progression free survival per treatment arm. Progressive Disease (PD) requires one of the following, increase of greater than or equal to 25% from baseline in: Serum M-component; Urine M-component; The difference between involved and uninvolved sFLC levels; The size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia.|36 Months|All Phase II Participants.||months||95% Confidence Interval|Median
692080|NCT01432600|Primary|Phase II - Overall Response Rate (ORR)|Overall response, Minimal Remission (MR) or better per treatment arm, using the uniform response criteria by the International Myeloma Working Group (IMWG) of pomalidomide in combination with high dose dexamethasone with or without cyclophosphamide in participants with relapsed and refractory myeloma. In addition, Minimal response was incorporated in those response criteria as this is a valid endpoint in patients with relapsed or refractory myeloma. MR: 25-49% reduction in serum paraprotein and a 50-89% reduction in urine light chain excretion; A 25-49% reduction in the size of soft tissue plasmacytoma must be demonstrated is applicable.|36 Months|All Phase II Participants.||percentage of participants||95% Confidence Interval|Number
692081|NCT01432600|Primary|Phase I - Maximum Tolerated Dose (MTD)|The maximum tolerated dose of oral weekly cyclophosphamide in milligrams (mg), in combination with pomalidomide and dexamethasone. Dose Escalation of Cyclophosphamide, orallly (PO) days 1, 8, 15 as follows: Level 1: 300 mg; Level 2: 400 mg; Level 3: 500 mg. The period for assessment of Dose Limiting Toxicity (DLT) is the first cycle (28 days). The following toxicities will be considered dose limiting if encountered only in the phase I portion of the study: Febrile neutropenia; Grade 3 or 4 non-hematologic toxicity related to treatment with pomalidomide or cyclophosphamide; Participants must have received optimal symptomatic treatment for Grade 3 or 4 nausea, vomiting, or diarrhea to be considered a DLT; Grade 4 transaminitis; Grade 3 transaminitis must be present for ≥ 7 days to be considered a DLT; Grade 4 thrombocytopenia for 7 or more days; Grade 4 neutropenia for 7 or more days.|28 Days|All Phase I Participants.||mg|||Number
692082|NCT01432574|Secondary|Change in Antibody Titers|Change in antibody titers 1 month post-dose 3 of vaccine. For each vaccine component, the geometric mean titers (GMT) and the corresponding 95% confidence intervals (CI) were calculated for antibody titers at each time-point (Day 1 and Month 7). For each participant, the difference in antibody titers between these 2 time-points (titers at Month 7 minus titers at Day 1) was calculated. The mean of antibody titer change and its 95% CI were calculated. Immune response was measured with a multiplex competitive Luminex immunoassay (anti-HPV-6, -11, -16, and -18 chemiluminescence immunoassay analyzer (cLIA); Merck) at Pharmaceutical Product Development (PPD). Briefly, this assay simultaneously quantitates neutralizing antibodies to HPV 6, 11, 16, and 18 in 50 μL of serum. mMU/ml is an arbitrary unit of measure derived after comparing relative inhibition of mAb-PE binding to a pooled standard reference serum using a four-parameter logistic curve fit and correcting for dilution.|Points: Day 1 and Month 7|Participants who had specimens contributing to both Day 1 and Month 7 serum HPV antibody evaluations.||mMU/mL (geometric mean titer)||95% Confidence Interval|Geometric Mean
692083|NCT01432574|Primary|Percentage of Participants Seropositive at Month 7|Immune response was measured with a multiplex competitive Luminex immunoassay (anti-HPV-6, -11, -16, and -18 chemiluminescence immunoassay analyzer (cLIA); Merck) at Pharmaceutical Product Development (PPD). Briefly, this assay simultaneously quantitates neutralizing antibodies to HPV 6, 11, 16, and 18 in 50 μL of serum. The seronegative study population at Day 1 (no detectable HPV antibody titers at Day 1) were to be categorized as seroconverted due to increase in titer levels for each vaccine component at Month 7.|7 Months|Participants who had specimens contributing to both Day 1 and Month 7 serum HPV antibody evaluations.||percentage of participants|||Number
692084|NCT01432561|Primary|Time to Peak Plasma Cysteamine Concentration (Tmax)|Subjects were randomized to one of two possible treatment sequences using block randomization: Sequence 1 - fasted, high-fat, high-protein or Sequence 2 - high-protein, high-fat, fasted. Sequence assignment determined the treatment condition corresponding to Period I, II & III visits.|0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180 minutes, and 3.5, 4, 4.5, 5, 6 hours post‐dose|||minutes||Standard Deviation|Mean
692085|NCT01432561|Primary|Peak Plasma Cysteamine Concentration (Cmax)|Subjects were randomized to one of two possible treatment sequences using block randomization: Sequence 1 - fasted, high-fat, high-protein or Sequence 2 - high-protein, high-fat, fasted. Sequence assignment determined the treatment condition corresponding to Period I, II & III visits.|0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180 minutes, and 3.5, 4, 4.5, 5, 6 hours post‐dose|||uM||Standard Deviation|Mean
703366|NCT00094900|Secondary|Mean Change in Prednisone Dose||3 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||mg/day||Standard Error|Mean
692087|NCT01432535|Primary|Apparent Volume of Distribution (Vd/F)|Vd/F is defined as the distribution of a medication between the plasma and the rest of the body after the dose. It is the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of the drug.|From hour 0 (pre-dose) up to 288 hours post-dose|All treated participants with the exception of 1 moderate renal impairment participant found to be ineligible for this arm.||Liters||95% Confidence Interval|Geometric Mean
692088|NCT01432535|Primary|Apparent Total Body Clearance (CL/F)|CL/F is a calculation of the rate at which a drug is removed from the body via renal, hepatic and other clearance pathways, expressed as volume (milliliters) per unit of time (minutes).|From hour 0 (pre-dose) up to 288 hours post-dose|All treated participants with the exception of 1 moderate renal impairment participant found to be ineligible for this arm.||mL/min||95% Confidence Interval|Number
692089|NCT01432535|Primary|Apparent Terminal Half-life (T1/2)|T1/2 is the time required for a given drug concentration in the plasma to decrease by 50%.|From hour 0 (pre-dose) up to 288 hours post-dose|All treated participants with the exception of 1 moderate renal impairment participant found to be ineligible for this arm.||Hours||Geometric Coefficient of Variation|Geometric Mean
692090|NCT01432535|Primary|Time to Maximum Observed Serum Concentration (Tmax)|Tmax is a measure of the time to reach the maximum concentration in the plasma after the drug dose.|From hour 0 (pre-dose) up to 288 hours post-dose|All treated participants with the exception of 1 moderate renal impairment participant found to be ineligible for this arm.||hours||95% Confidence Interval|Median
692091|NCT01432535|Primary|Maximum Observed Serum Concentration (Cmax)|Cmax is a measure of the maximum amount of drug in the plasma after the dose is given.|From hour 0 (pre-dose) to 288 hours post-dose|All treated participants with the exception of 1 moderate renal impairment participant found to be ineligible for this arm.||pg/mL||95% Confidence Interval|Geometric Mean
692092|NCT01432535|Primary|AUC From Time 0 to the Last Measurable Sample (AUC0-last)|AUC0-last is a measure of the total amount of drug in the plasma from the dose to the last measurable sample.|From hour 0 (pre-dose) up to 288 hours post-dose|All treated participants with the exception of 1 moderate renal impairment participant found to be ineligible for this arm.||pg*hr/mL||95% Confidence Interval|Least Squares Mean
692093|NCT01432535|Primary|Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞)|AUC0-∞ is a measure of the mean concentration levels of drug in the plasma after the dose.|From hour 0 (pre-dose) to 288 hours post-dose|All treated participants with the exception of 1 moderate renal impairment participant found to be ineligible for this arm.||pg*hr/mL||95% Confidence Interval|Least Squares Mean
692094|NCT01432457|Secondary|Change From Baseline on the Arizona Sexual Experiences (ASEX) Scale Total Score|"The ASEX scale has 5 items to assess sexual functioning with a 1-week recall period. The 5 items assess sex drive, ease of arousal, ease of erection/lubrication, ease of orgasm and orgasm satisfaction. Subjects were encouraged to complete all 5 items regardless of sexual activity during the past week. However, all analyses utilized only the data for the visits where the presence of sexual activity was indicated.
Each individual score ranged from 1 to 6; the total score (based on the sum of the individual items) ranged from 5 to 30; higher scores indicated worse sexual function."|Baseline to Week 8 (final on-therapy)|Safety population: randomized subjects who have taken at least 1 dose of double-blind investigational product. Imputation technique: ASEX scale total score analyzed using analysis of covariance based on LOCF data. ASEX data only analyzed for subjects indicating sexual activity at baseline and a timepoint during post-baseline.||Units on a scale||Standard Error|Mean
692095|NCT01432457|Secondary|Hamilton Rating Scale for Depression, 17-item (HAM-D17) Remission Rate|HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Each item is scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), for a maximum total score of 52; higher scores indicate more depression. Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) total score of ≤ 7.|Baseline to week 8 (final on-therapy)|Intent-to-Treat (ITT) population: randomized subjects who have taken at least 1 dose of double-blind investigational product, and had a baseline and at least one post-baseline HAM-D17 total score. Imputation technique: A logistic regression model based on last- observation-carried-forward (LOCF) data was used.||percentage of the number of participants|||Number
692096|NCT01432457|Secondary|Hamilton Rating Scale for Depression, 17-item (HAM-D17) Response Rate|HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Each item is scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), for a maximum total score of 52; higher scores indicate more depression. A response is defined as ≥ 50% decrease from baseline on Hamilton Psychiatric Rating Scale for Depression (HAM-D17) total score.|Baseline to Week 8 (final on-therapy)|Intent-to-Treat (ITT) population: randomized subjects who have taken at least 1 dose of double-blind investigational product, and had a baseline and at least one post-baseline HAM-D17 total score. Imputation technique: A logistic regression model based on last-observation-carried-forward (LOCF) data was used.||percentage of the number of participants|||Number
692097|NCT01432457|Secondary|Change From Baseline on the Clinical Global Impression-Severity (CGI-S) Score|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = worse state.|Baseline to Week 8 (final on-therapy)|Intent-to-Treat (ITT) population: randomized subjects who have taken at least 1 dose of double-blind investigational product, and had a baseline and at least 1 post-baseline HAM-D17 total score. Imputation technique: Analysis of covariance (ANCOVA) was used based on last-observation-carried-forward (LOCF) data.||Units on scale||Standard Error|Mean
692098|NCT01432457|Secondary|Change From Baseline on the Clinical Global Impression-Severity Score (CGI-S)|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = worse state.|Baseline to Week 8 (final on-therapy)|Intent-To-Treat (ITT) population: randomized subjects who have taken at least 1 dose of double-blind investigational product, and had a baseline and at least 1 post-baseline HAM-D17 total score. Imputation technique: A mixed effects model for repeated measures (MMRM) was used with the baseline CGI-S score as a covariate.||Units on scale||Standard Error|Mean
738606|NCT00450749|Secondary|Serum Concentrations of Insulin-like Growth Factor (IGF)-1 and IGF Binding Protein-3||At baseline and at 4-7 weeks||||||
692099|NCT01432457|Secondary|Change From Baseline on the Clinical Global Impression Scale-Improvement (CGI-I)|CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Higher score = worse outcome.|Baseline to Week 8 (final on-therapy)|Intent-To-Treat (ITT) population: randomized subjects who have taken at least 1 dose of double-blind investigational product, and had a baseline and at least 1 post-baseline HAM-D17 total score. Imputation technique: The Cochran-Mantel-Haenszel row-mean-score-difference test using ridit scores based on last-observation-carried-forward (LOCF) data.||number of participants|||Number
692100|NCT01432457|Primary|Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17) at Week 8|HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Each item is scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), for a maximum total score of 52; higher scores indicate more depression. Change from baseline: score at observation minus score at baseline|Baseline to Week 8 (final on-therapy)|Intent-To-Treat (ITT) population: randomized subjects who have taken at least 1 dose of double-blind investigational product, and had a baseline and at least 1 post-baseline HAM-D17 total score. Imputation technique: Analysis of covariance (ANCOVA) was used based on last-observation-carried-forward (LOCF) data.||Units on a scale||Standard Error|Mean
692101|NCT01432457|Primary|Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17) at Week 8|HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Each item is scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), for a maximum total score of 52; higher scores indicate more depression. Change from baseline: score at observation minus score at baseline.|Baseline to Week 8 (final on-therapy)|Intent-To-Treat (ITT) population: randomized subjects who have taken at least 1 dose of double-blind investigational product, and had a baseline and at least 1 post-baseline HAM-D17 total score. Imputation technique: A mixed effects model for repeated measures (MMRM) was used with the baseline HAM-D17 score as a covariate.||Units on a scale||Standard Error|Mean
692102|NCT01432444|Secondary|Mean Clinical Global Impression-Improvement Score (CGI-I) by Week.|The efficacy of trial medication was rated for each participant using the CGI-I scale. The study physician would rate the participants total improvement whether or not it was entirely due to drug treatment. All responses were compared to the participants condition at Baseline of the appropriate phase. The CGI-I during Phase B were assessed relative to the participants condition at the Phase B Baseline visit. Response choices included: 0 = not assessed; 1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; and 7 = very much worse.|Week 4, 12 and 24|The core dataset for all efficacy analyses is the ITT dataset which consisted of data from all participants who entered Phase B regardless of receiving a dose in the Open-label Aripiprazole IM Depot Treatment Phase.||Units on a scale||Standard Deviation|Mean
692103|NCT01432444|Secondary|Change From Baseline in Clinical Global Impression-Severity Score (CGI-S).|The severity of illness for each participant were rated using the CGI-S scale. To assess CGI-S, study physician were to answer the following question: “Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?” Response choices included: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill patients.|Baseline to Week 24|The core dataset for all efficacy analyses is the ITT dataset which consisted of data from all participants who entered Phase B regardless of receiving a dose in the Open-label Aripiprazole IM Depot Treatment Phase.||Units on a scale||Standard Deviation|Mean
692104|NCT01432444|Secondary|Change From Baseline in PANSS Negative Subscale Score.|The PANSS consists of three subscales with a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicates (absence of symptoms) and a score of 7 indicates (extremely severe symptoms). The symptom constructs for each subscale are as follows: 7 Positive subscale symptom constructs, 7 Negative subscale symptom constructs and 16 General Psychopathology subscale symptom constructs. The 7 negative symptom constructs are blunted affect, emotional withdrawal, poor rapport, passive pathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS Negative Subscale ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms).|Baseline to Week 24|The core dataset for all efficacy analyses is the ITT dataset which consisted of data from all participants who entered Phase B regardless of receiving a dose in the Open-label Aripiprazole IM Depot Treatment Phase.||Units on a scale||Standard Deviation|Mean
692105|NCT01432444|Secondary|Change From Baseline in PANSS Positive Subscale Score.|The PANSS consists of three subscales with a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicates (absence of symptoms) and a score of 7 indicates (extremely severe symptoms). The symptom constructs for each subscale are as follows: 7 Positive subscale symptom constructs, 7 Negative subscale symptom constructs and 16 General Psychopathology subscale symptom constructs. The 7 positive symptom constructs are delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity suspiciousness/ persecution, and hostility. The PANSS Positive Subscale ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms).|Baseline to Week 24|The core dataset for all efficacy analyses is the ITT dataset which consisted of data from all participants who entered Phase B regardless of receiving a dose in the Open-label Aripiprazole IM Depot Treatment Phase.||Units on a scale||Standard Deviation|Mean
692106|NCT01432444|Secondary|Change From Baseline in PANSS (Positive and Negative Syndrome Scale) Total Score.|The PANSS consists of three subscales with a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicates (absence of symptoms) and a score of 7 indicates (extremely severe symptoms). The symptom constructs for each subscale are as follows: 7 Positive subscale symptom constructs, 7 Negative subscale symptom constructs and 16 General Psychopathology subscale symptom constructs. The PANSS total score ranges from 30 to 210.|Baseline to Week 24|The core dataset for all efficacy analyses is the ITT dataset which consisted of data from all participants who entered Phase B regardless of receiving a dose in the Open-label Aripiprazole IM Depot Treatment Phase.||Units on a scale||Standard Deviation|Mean
699285|NCT00002540|Secondary|T2 DRE Screening Results|Digital Rectal Examination (DRE) results|T2 (two years after entry)|All males in the Prostate Screening arm who had a DRE screen at T2 were analyzed.||Participants|||Number
692107|NCT01432444|Primary|Number of Inpatient Psychiatric Hospitalization for Retrospective Period (Months 4-6) and Prospective Period (Months 4-6).|The comparison of inpatient psychiatric hospitalization rates (proportion of patients with ≥ inpatient psychiatric hospitalizations) between the retrospective period months 4-6 (Weeks-12 to -24) while on oral standard of care antipsychotic treatment and the prospective period Phase B months 4-6 (Weeks 12 to 24) after the switch to aripiprazole IM depot. Open-label Aripiprazole IM Depot Treatment Phase 3-month Completer sample comprised of all participants who entered open-label aripiprazole IM depot treatment Phase and completed at least 3 months of treatment. This sample was used for the primary endpoint analysis (N=336).|Retrospective period Months 4-6; Prospective period Months 4-6|The core dataset for all efficacy analyses is the Intent-to-Treat (ITT) dataset which consisted of data from all participants who entered Phase B regardless of receiving a dose in the Open-label Aripiprazole IM Depot Treatment Phase.||participants|||Number
692108|NCT01432405|Secondary|Plasma Adipocytokines|the effect of the intervention on plasma adiponectin levels.|one year|||microgram per ml||Standard Error|Mean
692109|NCT01432405|Primary|Hepatic Fat|The effect of exenatide and pioglitazone on liver fat content after one year of treatment in patients with type 2 diabetes.|one year|||percent of liver fat||Standard Error|Mean
692110|NCT01432379|Secondary|Incidence Rate of Intractable Migraine|Incidence rates are reported for subjects with events per 1,000 person-months and are based on the first reported occurrence of intractable migraine from study enrollment up to 64 weeks. Intractable migraine is a migraine that does not seem to go away.|64 weeks|Treated Population: all patients who received at least 1 dose of botulinum toxin Type A||events per 1,000 person-months||95% Confidence Interval|Number
692111|NCT01432379|Primary|Incidence Rate of Dysphagia|Incidence rates are reported for subjects with events per 1,000 person-months and are based on the first reported occurrence of dysphagia from study enrollment up to 64 weeks. Dysphagia is difficulty or discomfort swallowing.|64 weeks|Treated Population: all patients who received at least 1 dose of botulinum toxin Type A||events per 1,000 person-months||95% Confidence Interval|Number
692112|NCT01432366|Secondary|Correlation Between Demographic and Clinical Factors and Beliefs About Medicines Questionnaire Concerns Score at Baseline|Correlation between BMQ concerns score and participant’s characteristics (demography and clinical factors) was assessed by using Pearson correlation coefficient. BMQ consists of two 5-item scales assessing participants’ beliefs about necessity of prescribed medication for controlling disease (BMQ necessity) and their concerns about potential adverse consequences of taking it (BMQ concerns). Respondents indicate their degree of agreement with each statement on five-point Likert scale, ranging from 1=strongly disagree to 5=strongly agree. Total scores for necessity and concerns scales were summed; range from 5 to 25. Higher scores = stronger beliefs. Participant’s characteristics included age, height, weight, BMI, time since first RA symptoms, diagnosis, number of comorbidities and number of joint replacement or surgery.|Baseline|BAS included all participants who were enrolled in the study and seen at baseline. Here, ‘n’ signifies those participants who were evaluable for the specified characteristics.||correlation coefficient||95% Confidence Interval|Number
692113|NCT01432366|Secondary|Correlation Between Demographic and Clinical Factors and Beliefs About Medicines Questionnaire Necessity Score at Baseline|Correlation between BMQ necessity score and participant’s characteristics (demography and clinical factors) was assessed by using Pearson correlation coefficient. BMQ consists of two 5-item scales assessing participants’ beliefs about necessity of prescribed medication for controlling disease (BMQ necessity) and their concerns about potential adverse consequences of taking it (BMQ concerns). Respondents indicate their degree of agreement with each statement on five-point Likert scale, ranging from 1=strongly disagree to 5=strongly agree. Total scores for necessity and concerns scales were summed; range from 5 to 25. Higher scores = stronger beliefs. Participant’s characteristics included age, height, weight, body mass index (BMI), time since first RA symptoms, diagnosis, number of comorbidities and number of joint replacement or surgery.|Baseline|BAS included all participants who were enrolled in the study and seen at baseline. Here, ‘n’ signifies those participants who were evaluable for the specified characteristics.||correlation coefficient||95% Confidence Interval|Number
692114|NCT01432366|Secondary|Pearson Correlation Coefficient Between Beliefs About Medicines Questionnaire and Medication Adherence Rating Scale at Month 6 and 12|BMQ Necessity and BMQ Concerns are described in outcome measure 1 and 2 respectively. BMQ necessity–concerns: difference between necessity and concerns scales (ranges from -20 to +20, where higher score=better cost–benefit). BMQ Harm scale assesses the degree to which medicines are perceived as harmful. BMQ over use scale assesses beliefs about use of medicines and if they are overprescribed by clinicians. BMQ Harm and overuse scales comprise of 4 items, each item assessed on a 5-point scale (1=strongly disagree to 5=strongly agree). Total BMQ Harm and overuse scores were calculated as the sum of individual items and ranges from 4 to 20. Higher scores =more negative orientation towards medicines. MARS consists of a 5-item scale assessing the frequency of non-adherent behavior of participants for taking medication (5=never, 4=rarely, 3=sometimes, 2=often, 1=very often). Scores for each of the 5 items were summed; ranging from 5 to 25. Higher scores=higher levels of adherence.|Month 6, 12|FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, ‘n’ signifies those participants who were evaluable for each specified subscales.||correlation coefficient||95% Confidence Interval|Number
692115|NCT01432366|Secondary|Pearson Correlation Coefficient Between Beliefs About Medicines Questionnaire and Medication Adherence Rating Scale (MARS) at Baseline|BMQ Necessity and BMQ Concerns are described in outcome measure 1 and 2 respectively. BMQ necessity–concerns: difference between necessity and concerns scales (ranges from -20 to +20, where higher score=better cost–benefit). BMQ Harm scale assesses the degree to which medicines are perceived as harmful. BMQ over use scale assesses beliefs about use of medicines and if they are overprescribed by clinicians. BMQ Harm and overuse scales comprise of 4 items, each item assessed on a 5-point scale (1=strongly disagree to 5=strongly agree). Total BMQ Harm and overuse scores were calculated as the sum of individual items and ranges from 4 to 20. Higher scores =more negative orientation towards medicines. MARS consists of a 5-item scale assessing the frequency of non-adherent behavior of participants for taking medication (5=never, 4=rarely, 3=sometimes, 2=often, 1=very often). Scores for each of the 5 items were summed; ranging from 5 to 25. Higher scores=higher levels of adherence.|Baseline|BAS included all participants who were enrolled in the study and seen at baseline. Here, ‘n’ signifies those participants who were evaluable for each specified subscales.||correlation coefficient||95% Confidence Interval|Number
692116|NCT01432366|Secondary|Change From Baseline in Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 12|BMQ consists of two 5-item scales assessing participants’ agreement or strong agreement with beliefs about BMQ necessity and BMQ concerns. The items were: BMQ1: Necessity (my health at present depends on my medicines); BMQ2: Concern (having to take medications worries me); BMQ3: Necessity (my life would be impossible without my medications); BMQ4: Concern (I sometimes worry about the long term effects of my medications); BMQ5: Necessity (without my medications I would be very ill); BMQ6: Concern (my medications are mystery to me); BMQ7: Necessity (my health in the future will depend on my medications); BMQ8:Concern (my medications disrupt my life); BMQ9: Necessity (I sometimes worry about becoming too dependent on my medications); BMQ10: Concern (my medications protect me from becoming worse); BMQ11: Necessity (these medicines cause to me unpleasant adverse events).|Baseline, Month 12|FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here 'n' signifies those participants who were evaluable at the specified time points for the given sub-scale items.||percentage of participants|||Number
692117|NCT01432366|Secondary|Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 6 and 12|BMQ consists of two 5-item scales assessing participants’ agreement or strong agreement with beliefs about BMQ necessity and BMQ concerns. The items were: BMQ1: Necessity (my health at present depends on my medicines); BMQ2: Concern (having to take medications worries me); BMQ3: Necessity (my life would be impossible without my medications); BMQ4: Concern (I sometimes worry about the long term effects of my medications); BMQ5: Necessity (without my medications I would be very ill); BMQ6: Concern (my medications are mystery to me); BMQ7: Necessity (my health in the future will depend on my medications); BMQ8:Concern (my medications disrupt my life); BMQ9: Necessity (I sometimes worry about becoming too dependent on my medications); BMQ10: Concern (my medications protect me from becoming worse); BMQ11: Necessity (these medicines cause to me unpleasant adverse events).|Month 6, 12|FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here 'n' signifies those participants who were evaluable at the specified time points for the given sub-scale items.||percentage of participants|||Number
692118|NCT01432366|Secondary|Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Baseline|BMQ consists of two 5-item scales assessing participants’ agreement or strong agreement with beliefs about BMQ necessity and BMQ concerns. The items were: BMQ1: Necessity (my health at present depends on my medicines); BMQ2: Concern (having to take medications worries me); BMQ3: Necessity (my life would be impossible without my medications); BMQ4: Concern (I sometimes worry about the long term effects of my medications); BMQ5: Necessity (without my medications I would be very ill); BMQ6: Concern (my medications are mystery to me); BMQ7: Necessity (my health in the future will depend on my medications); BMQ8:Concern (my medications disrupt my life); BMQ9: Necessity (I sometimes worry about becoming too dependent on my medications); BMQ10: Concern (my medications protect me from becoming worse); BMQ11: Necessity (these medicines cause to me unpleasant adverse events).|Baseline|BAS included all participants who were enrolled in the study and seen at baseline. Here 'n' signifies those participants who were evaluable for the given sub-scale items.||percentage of participants|||Number
692119|NCT01432366|Secondary|Correlation Between Evolution of Beliefs About Medicines Questionnaire Concerns and Safety|Correlation between evolution of BMQ concerns score and safety was assessed by calculating Spearman correlation coefficient between change from baseline in BMQ concerns score and safety score at Month 6 and 12. BMQ concerns is a 6-item scale assessing participant’s concerns about potential adverse consequences (range: 1=strongly disagree to 5=strongly agree). Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). Safety was assessed by analyzing the incidence, type and severity of the reported AEs considered related to anti-TNF- alpha therapy.|Month 6, 12|FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, ‘n’ signifies those participants who were evaluable at each specified time point.||correlation coefficient||95% Confidence Interval|Number
692120|NCT01432366|Secondary|Correlation Between Evolution of Beliefs About Medicines Questionnaire Concerns and Disease Activity Score Based on 28 Joints Count|Correlation between evolution of BMQ concerns score and DAS28 score was assessed by calculating Pearson correlation coefficient between change from baseline in DAS28 score and BMQ concerns score at Month 6 and 12. BMQ concerns is a 6-item scale assessing participant’s concerns about potential adverse consequences (range: 1=strongly disagree to 5=strongly agree). Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). DAS28: calculated from number of SJC; TJC using 28 joints count, ESR (mm/hour) and participant's assessment of DA on VAS (range 0 [very well] to 100 mm [extremely bad]). DAS28 <=3.2= low DA; >3.2 to <=5.1= moderate DA; >5.1=high DA; <2.6=remission.|Month 6, 12|FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, ‘n’ signifies those participants who were evaluable at specified time point.||correlation coefficient||95% Confidence Interval|Number
692121|NCT01432366|Secondary|Correlation Between Evolution of Beliefs About Medicines Questionnaire Necessity Score and Safety|Correlation between evolution of BMQ necessity score and safety was assessed by calculating Spearman correlation coefficient between change from baseline in safety score and BMQ necessity score at Month 6 and 12. BMQ necessity: 5-item scale assessing participant’s beliefs about necessity of medications for controlling disease. Participants indicate their degree of agreement on a 5-point scale, ranging from 1=strongly disagree to 5=strongly agree. Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). Safety was assessed by analyzing the incidence, type and severity of the reported AEs considered related to anti-TNF- alpha therapy.|Month 6, 12|FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, ‘n’ signifies those participants who were evaluable at specified time point.||correlation coefficient||95% Confidence Interval|Number
692210|NCT01431521|Primary|Number of Participants Experiencing One or More Adverse Events (AE)|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to 10 weeks|All Subjects as Treated (AST) Population consists of all participants who received at least one dose of the study drug.||Participants|||Number
692122|NCT01432366|Secondary|Correlation Between Evolution of Beliefs About Medicines Questionnaire Necessity Score and Disease Activity Score Based on 28 Joints Count|Correlation between evolution of BMQ necessity score and DAS28 score was assessed by calculating Pearson correlation coefficient between change from baseline in DAS28 score and BMQ necessity score at Month 6 and 12. BMQ necessity: 5-item scale assessing participant’s beliefs about necessity of medications for controlling disease. Participants indicate their degree of agreement on a 5-point scale, ranging from 1=strongly disagree to 5=strongly agree. Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). DAS28: calculated from number of SJC; TJC using 28 joints count, ESR (mm/hour) and participant's assessment of DA on VAS (range 0 [very well] to 100 mm [extremely bad]). DAS28 <=3.2= low DA; >3.2 to <=5.1= moderate DA; >5.1=high DA; <2.6=remission.|Month 6, 12|FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, ‘n’ signifies those participants who were evaluable at specified time point.||correlation coefficient||95% Confidence Interval|Number
692123|NCT01432366|Secondary|Correlation Between Beliefs About Medicines Questionnaire Concerns Score and Safety at Month 12|Correlation between BMQ concerns score and safety was assessed by using Spearman correlation coefficient. BMQ Concerns is a 6-item scale assessing participant’s concerns about potential adverse consequences (range: 1=strongly disagree to 5=strongly agree). Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). Safety was assessed by analyzing the incidence, type and severity of the reported AEs considered related to anti-TNF- alpha therapy.|Month 12|FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||correlation coefficient||95% Confidence Interval|Number
692124|NCT01432366|Secondary|Correlation Between Beliefs About Medicines Questionnaire Concerns Score and Disease Activity Score Based on 28 Joints Count at Month 12|Correlation between BMQ concerns score and DAS28 score was assessed by using Pearson correlation coefficient. BMQ concerns is a 6-item scale assessing participant’s concerns about potential adverse consequences (range: 1=strongly disagree to 5=strongly agree). Participants indicate their degree of agreement on a 5-point scale, ranging from 1=strongly disagree to 5=strongly agree. Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). DAS28: calculated from number of SJC; TJC using 28 joints count, ESR (mm/hour) and participant's assessment of DA on VAS (range 0 [very well] to 100 mm [extremely bad]). DAS28 <=3.2= low DA; >3.2 to <=5.1= moderate DA; >5.1=high DA; <2.6=remission.|Month 12|FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||correlation coefficient||95% Confidence Interval|Number
692125|NCT01432366|Secondary|Correlation Between Beliefs About Medicines Questionnaire Necessity Score and Safety at Month 12|Correlation between BMQ necessity score and safety was assessed by using Spearman correlation coefficient. BMQ necessity: 5-item scale assessing participant’s beliefs about necessity of medications for controlling disease. Participants indicate their degree of agreement on a 5-point scale, ranging from 1=strongly disagree to 5=strongly agree. Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). Safety was assessed by analyzing the incidence, type and severity of the reported adverse events (AEs) considered related to anti-TNF- alpha therapy.|Month 12|FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||correlation coefficient||95% Confidence Interval|Number
692126|NCT01432366|Primary|Correlation Between Beliefs About Medicines Questionnaire (BMQ) Necessity Score and Disease Activity Score Based on 28 Joints Count (DAS28) at Month 12|Correlation between BMQ necessity and DAS28 was assessed by using Pearson correlation coefficient. BMQ necessity: 5-item scale assessing participant’s beliefs about necessity of medications for controlling disease. Participants indicate degree of agreement on a 5-point scale, ranging from 1=strongly disagree to 5=strongly agree. Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). DAS28: calculated from number of swollen joint count (SJC); tender joint count (TJC) using 28 joints count, erythrocyte sedimentation rate (ESR) (millimeter per hour [mm/hour]) and participant's assessment of disease activity (DA) on visual analog scale (VAS) (range 0 [very well] to 100 millimeter (mm) [extremely bad]). DAS28 less than or equal to (<=) 3.2=low DA; greater than (>) 3.2 to <=5.1=moderate DA; >5.1=high DA; <2.6=remission.|Month 12|Full Analysis Set (FAS) included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||correlation coefficient||95% Confidence Interval|Number
692127|NCT01432327|Secondary|Step Count|Daily number of steps|One Year||||||
692128|NCT01432327|Secondary|Stages of Motivational Readiness for Physical Activity|According to The Stages of Motivational Readiness for Change Model (SOC), individuals move through a series of stages as they adopt and maintain a new habit(Prochaska & DiClemente, 1983). Specifically, the stages include Precontemplation, Contemplation, Preparation, Action, and Maintenance.The relevant variables were assessed in a self-administered questionnaire.|One Year||||||
692129|NCT01432327|Secondary|Percent of Participants Losing Fat Percentage|The amount of body fat is measured by bioelectrical impedance analysis (BIA).|One Year||||||
692130|NCT01432327|Secondary|Daily Energy Expenditure in Physical Activity|Minutes of physical activity. Activities can be classified as moderate-intensity, vigorous-intensity or very vigorous-intensity activities based upon the amount of energy used by the body while doing the activity.|One year||||||
692318|NCT01430624|Secondary|Non-medical Use of Prescription Drugs Frequency|Number of days of use within the 14 days prior to follow-up assessment|14 days prior to 6 week, 3 month, 6 month follow-up|2 participants had missing data at 6 month follow-up||days of use||Standard Deviation|Mean
692319|NCT01430624|Primary|Marijuana Use Frequency|Number of days of use within the 14 days prior to follow-up assessment|14 days prior to 6 week, 3 month, 6 month follow-up|||days of use||Standard Deviation|Mean
692131|NCT01432327|Primary|Physical Activity Level|To account for differences in body size and composition, the 24-hour energy requirement (kcal/day) is expressed as a multiple of the basal metabolic rate per 24 hours by using the PAL value (PAL = total energy expenditure/basal metabolic rate). A desirable PAL includes the regular practice of physical activity at work or in spare time with an intensity and duration that will reduce the risk of becoming overweight and developing a variety of non-communicable chronic diseases usually associated as co-morbidities with obesity. This corresponds to PAL values of 1.75 and higher.|One year|Intention to treat analysis was used and analyses data from all participants, including those who did not complete the study||Metabolic Equivalent||Standard Deviation|Mean
692132|NCT01432275|Secondary|Preference Questionnaire (Insulin Calculator Not Activated)|"Result for the question: The meter the subject would change to"|25 days (results recorded after the two 7 day periods)|Subjects used a comparator blood glucose meter for 7 days and a FreeStyle InsuLinx meter for 7 days (insulin calculator deactivated). Subjects then completed a preference questionnaire. Each subject was assigned one of the three competitor systems. Subjects had not previously used either study device. Analysis per protocol.||participants|||Number
692133|NCT01432275|Primary|Overall User Preference for the FreeStyle InsuLinx System Compared to Current Method.|Overall user preference of the FreeStyle InsuLinx system as a diabetes management tool when compared against their usual method.|25 days|A comparator blood glucose meter was used for 7 days and a FreeStyle InsuLinx for 7 days (insulin calculator inactive). For the last 10 days a FreeStyle InsuLinx with the insulin calculator activated was used. Each subject was assigned one of the three competitor systems. Subjects had not previously used any study systems. Analysis per protocol.||participants|||Number
692134|NCT01432262|Secondary|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination to 1 Month Post-Vaccination|Geometric mean fold rises (GMFRs) for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from pre-vaccination to 1 month post-vaccination were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|Pre-vaccination to 1 month (28 to 42 days) after vaccination|EIP: eligible participants who received vaccine, had blood drawn within the pre-specified time frames, had at least 1 valid and determinate assay result, received no prohibited vaccines, and had no other major protocol violations. Here “N” signifies participants with valid and determinate assay results at both pre-vaccination and post-vaccination.||fold rise||95% Confidence Interval|Geometric Mean
692135|NCT01432262|Secondary|Percentage of Participants Achieving Serotype-Specific Opsonophagocytic Activity (OPA) Titer With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination|Percentage of participants achieving OPA GMTs with at least LLOQ for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) determined in blood samples of all participants using microcolony OPA assay. Exact 2-sided CI based on observed proportion of participants. LLOQ for each serotype: 1=1:18, 3=1:12, 4=1:21, 5=1:29, 6A=1:37, 6B=1:43, 7F=1:210, 9V=1:345, 14=1:35, 18C=1:31, 19A=1:18, 19F=1:48, 23F=1:13.|One month (28 to 42 days) after vaccination|EIP: eligible participants who received vaccine, had blood drawn within the pre-specified time frames, had at least 1 valid and determinate assay result for proposed analysis, received no prohibited vaccines, and had no other major protocol violations.||percentage of participants||95% Confidence Interval|Number
692136|NCT01432262|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between vaccination and up to 1 month (28 to 42 days) after vaccination that were absent before treatment or that worsened relative to pre-treatment state.|Baseline up to 1 Month (28 to 42 days) after vaccination|Safety Population included all participants who received the vaccine.||percentage of participants||95% Confidence Interval|Number
692137|NCT01432262|Primary|Percentage of Participants Reporting Pre-Specified Systemic Events Within 14 Days After Vaccination|Systemic events reported using electronic diary. Fever-Any:>=38 degrees Celsius (C), Mild (M):>=38 to <38.5 degrees C, Moderate(Mod):>=38.5 to <39 degrees C, Severe (S):>=39 to <=40 degrees C, Potentially life threatening:>40 degrees C. Headache, fatigue, muscle pain, joint pain- Any: present, M:did not interfere with activity, Mod:some interference, S:activity prevented. Vomiting- Any:present, M:1-2 times/day (d), Mod:>2/d, S:required intravenous hydration. Diarrhoea- Any:present, M:2-3 loose stools/d, Mod:4-5/d, S:>=6/d. All reports of fever >40 degrees C were confirmed as data entry errors.|Within 14 days after vaccination|Safety Population included all participants who received vaccine. N (Number of Participants Analyzed)=participants reporting yes for at least 1 day or no for all 14 days and n=participants reporting yes for at least 1 day or no for all 14 days for specified systemic event for each group respectively. Participants may be represented in >1 category.||percentage of participants||95% Confidence Interval|Number
692138|NCT01432262|Primary|Percentage of Participants Reporting Pre-Specified Local Reactions Within 14 Days After Vaccination|Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present), Mild (2.5 to 5.0 centimeters [cm]), Moderate (5.1 to 10.0 cm), Severe (>10 cm). Pain at injection site scaled as Any (pain present), Mild (does not interfere with activity), Moderate (interferes with activity), Severe (prevents daily activity).|Within 14 days after vaccination|Safety Population included all participants who received vaccine. N (Number of Participants Analyzed)=participants reporting yes for at least 1 day or no for all 14 days and n=participants reporting yes for at least 1 day or no for all 14 days for specified local reaction for each group respectively. Participants may be represented in >1 category.||percentage of participants||95% Confidence Interval|Number
692177|NCT01431976|Secondary|Number of Participants Who Were Seizure Free as Confirmed by HV-EEG at Two Consecutive Visits in the Escalation Phase (EP)|EEG is a diagnostic test for epilepsy. The EEG machine records the brain’s electrical activity as a series of waveforms. HV is an activation technique used to provoke seizures during an EEG recording. An approximately 30-minute EEG with HV was performed on participants in a supine position. In the HV test, participants breathed through their mouths deeply and rapidly (at a rate of approximately 20-25 breaths/minute ) for 4 continuous minutes using a pin-wheel provided to them.|Up to Study Week 49|FAS||Participants|||Number
692139|NCT01432262|Primary|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination|Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using a quantitative functional OPA assay. Confidence intervals (CIs) for GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers. Individual OPA assay values below the assay LLOQ (lower limit of quantification) were set at a titer of 0.5*limit of detection (LOD [8]) = (titer of 4) for the purpose of calculating the OPA GMT.|One month (28 to 42 days) after vaccination|Evaluable Immunogenicity Population (EIP): eligible participants who received vaccine, had blood drawn within the pre-specified time frames, had at least 1 valid and determinate assay result for proposed analysis, received no prohibited vaccines, and had no other major protocol violations.||titer||95% Confidence Interval|Geometric Mean
692140|NCT01432236|Other Pre-specified|Health Utilization Assessment (Time for Help no Payment) at Baseline.|The healthcare utilization assessment was used to capture healthcare utilization data at Baseline. This assessment contained 10 questions related to aspects of healthcare services. 'Time for help no payment' refers to time other people spent without receiving payment to help with activities the patient cannot perform due to fibromyalgia.|Baseline|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.||Hours||Standard Deviation|Mean
692141|NCT01432236|Other Pre-specified|Health Utilization Assessment (Total Office Visits, Number of Hospitalizations and Number of Emergency Room Visits) at Baseline.|The healthcare utilization assessment was used to capture healthcare utilization data at Baseline. This assessment contained 10 questions related to aspects of healthcare services.|Baseline|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.||Visits||Standard Deviation|Mean
692142|NCT01432236|Other Pre-specified|Work Productivity and Activity Index-Specific Health Problem (WPAI-SHP) Questionnaire at Baseline.|WPAI-SHP assessed work productivity and impairment. It was a participant-rated, six-item questionnaire regarding current employment, hours missed and actually worked, and degree to which a specified health problem affected work productivity and regular activities over the past 7 days. Subscale scores included percent work time missed due to the health problem; percent impairment while working due to problem; percent overall work impairment due to problem; and percent activity impairment due to problem. Each subscale score was expressed as an impairment percentage (0-100) where higher numbers indicated greater impairment and less productivity.|Baseline|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.||Units on a scale||Standard Deviation|Mean
692143|NCT01432236|Other Pre-specified|Number of Participants With Categorical Scores on the C-SSRS at Post-Baseline.|C-SSRS assessed whether participant experienced following:completed suicide (1), suicide attempt (2) (response of Yes on “actual attempt”), preparatory acts toward imminent suicidal behavior (3) (Yes on “preparatory acts or behavior”), suicidal ideation (4) (Yes on “wish to be dead”, “non-specific active suicidal thoughts”, “active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7) (Yes on “Has subject engaged in non-suicidal self-injurious behavior”). Below table indicated one participant (10141023) treated with Pregabalin reported preparatory act. However upon study unblinding it was clarified that preparatory act occurred while the participant was taking placebo. Since preparatory act was reported at first visit of Period 2, by convention statistical summaries classified this under Pregabalin treatment.|From Visit 3 to Visit 14|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.||Participants|||Number
692144|NCT01432236|Other Pre-specified|Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) at Baseline.|C-SSRS assessed whether participant experienced following: completed suicide (1), suicide attempt (2) (response of “Yes” on “actual attempt”), preparatory acts toward imminent suicidal behavior (3) (“Yes” on “preparatory acts or behavior”), suicidal ideation (4) (“Yes” on “wish to be dead”, “non-specific active suicidal thoughts”, “active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7) (“Yes” on “Has participant engaged in non-suicidal self-injurious behavior”).|Baseline|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.||Participants|||Number
692145|NCT01432236|Other Pre-specified|Mean PSGA Score at End of Period.|PSGA was a single-item self-rated instrument that measured the participant’s overall status on an 11-point numeric rating scale (NRS) ranging from 0 (very poor) to 10 (very good).|End of each period, at Weeks 6 and 14|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.||Units on a scale||Standard Error|Least Squares Mean
692146|NCT01432236|Other Pre-specified|Mean Patient Static Global Assessment (PSGA) Score at Baseline.|PSGA was a single-item self-rated instrument that measured the participant’s overall status on an 11-point NRS ranging from 0 (very poor) to 10 (very good).|Baseline|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.||Units on a scale||Standard Deviation|Mean
692147|NCT01432236|Secondary|EQ-5D Score at End of Period.|EQ-5D is a standardized, participant-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point visual analog scale (0=worst, 100=best). EQ-5D summary index is obtained with a formula that weights each level of the dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health).|End of each period, at Weeks 6 and 14|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.||Units on a scale||Standard Error|Least Squares Mean
692148|NCT01432236|Secondary|Mean EuroQoL 5-Dimensions (EQ-5D) Score at Baseline.|EQ-5D is a standardized, participant-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point visual analog scale (0=worst, 100=best). EQ-5D summary index is obtained with a formula that weights each level of the dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health).|Baseline|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.||Units on a scale||Standard Deviation|Mean
692149|NCT01432236|Secondary|HADS at End of Period.|HADS: participant rated questionnaire with 2 subscales. HADS-A (anxiety) assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D (depression) assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.|End of each period, at Weeks 6 and 14|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.||Units on a scale||Standard Error|Least Squares Mean
692150|NCT01432236|Secondary|Hospital Anxiety and Depression Scale (HADS) at Baseline.|HADS: participant rated questionnaire with 2 subscales. HADS-A (anxiety) assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D (depression) assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.|Baseline|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.||Units on a scale||Standard Deviation|Mean
692151|NCT01432236|Secondary|Subjective Sleep Questionnaire - Parameter Estimates for Subjective Number of Awakenings Per Night After Sleep Onset at End of Period.|Subjective Sleep Questionnaire included, participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (numeric rating scale) for the previous night. Subjective number of awakenings after sleep onset was the subjective estimate of the total number of times the participant awakened during the night until final awakening.|End of each period, at Weeks 6 and 14|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.||Number of times awakened||Standard Error|Least Squares Mean
692152|NCT01432236|Secondary|Subjective Sleep Questionnaire - Mean Subjective Total Sleep Time at End of Period.|Subjective Sleep Questionnaire included, participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (numeric rating scale) for the previous night. Subjective total sleep time was the subjective estimate of the total amount of time the participant was asleep after lights out until final awakening.|End of each period, at Weeks 6 and 14|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.||Minutes||Standard Error|Least Squares Mean
692153|NCT01432236|Secondary|Subjective Sleep Questionnaire - Mean Latency to Sleep Onset at End of Period.|Subjective Sleep Questionnaire included, participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (numeric rating scale) for the previous night. Subjective latency to sleep onset was the subjective estimate of the amount of time to fall asleep after lights out.|End of each period, at Weeks 6 and 14|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.||Minutes||Standard Error|Least Squares Mean
692154|NCT01432236|Secondary|Subjective Sleep Questionnaire - Mean Subjective Wake After Sleep Onset at End of Period.|Subjective Sleep Questionnaire included, participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (numeric rating scale) for the previous night. Subjective wake after sleep onset was the subjective estimate of the total amount of time the participant was awake after initial sleep onset until final awakening.|End of each period, at Weeks 6 and 14|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.||Minutes||Standard Error|Least Squares Mean
692155|NCT01432236|Secondary|Subjective Sleep Questionnaire - Mean Sleep Quality at End of Period.|Subjective Sleep Questionnaire included 5 items: participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. Subjective rating of quality of sleep during the past night was done by selecting a number between 0 (very poor) and 10 (excellent). Mean sleep quality was calculated as the mean of the last seven days, the potential range of responses was therefore 0-10.|End of each period, at Weeks 6 and 14|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.||Units on a scale||Standard Error|Least Squares Mean
692156|NCT01432236|Secondary|Percentage of Participants With >=30% and >=50% Pain Reduction Based on Daily Pain Diary.|Participant with at least a 30% reduction in mean pain score from baseline (at randomization) to the endpoint at the end of each period (Visits 6 and 12) is considered a 30% responder, for the respective period. Similarly, a subject with at least a 50% reduction in mean pain score from baseline (at randomization) to the endpoint at the end of each period (Visits 6 and 12) is considered a 50% responder, for the respective period.|Visits 2, 6, and 12|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.||Percentage of participants|||Number
692157|NCT01432236|Other Pre-specified|PGIC at the End of Period 2.|PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Because of the crossover design and PGIC recall period (since starting study medication), the Period 1 PGIC data were felt to provide the clearest comparison across treatments, whereas Period 2 PGIC data were felt to have a more complex interpretation. Thus PGIC at End of Period 2 was separately analyzed from PGIC at End of Period 1.|End of Period 2 at Week 14|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.||Percentage of Participants|||Number
692158|NCT01432236|Secondary|Patient Global Impression of Change (PGIC) at the End of Period 1.|PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse).|End of Period 1 at Week 6|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.||Percentage of participants|||Number
692159|NCT01432236|Secondary|FIQ Score at End of Period.|This was a 20-item participant reported outcome instrument. It contained 10 subscales, which were combined to yield a total score. The first 11 questions were related specifically to physical functioning subscale, ranging from 0 to 10. The remaining 9 questions assessed pain, fatigue, stiffness, difficulty working, and symptoms of anxiety and depression ranging from 0 to 10. The higher values indicated greater impairment. All 20 were combined to form a total score ranging from 0 to 100, provides an estimation of fibromyalgia impact with higher scores indicating more impairment. The severity categorizations for the FIQ are: less than 40 (mild), 40-60 (moderate), and above 60 (severe).|End of each period, at Weeks 6 and 14|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation. Different number (N) for each category represents participants that were actually treated with pregabalin and placebo during the study.||Units on a scale||Standard Error|Least Squares Mean
692160|NCT01432236|Secondary|Fibromyalgia Impact Questionnaire (FIQ) Score at Baseline.|This was a 20-item participant reported outcome instrument. It contained 10 subscales, which were combined to yield a total score. The first 11 questions were related specifically to physical functioning subscale, ranging from 0 to 10. The remaining 9 questions assessed pain, fatigue, stiffness, difficulty working, and symptoms of anxiety and depression ranging from 0 to 10. The higher values indicated greater impairment. All 20 were combined to form a total score ranging from 0 to 100, provides an estimation of fibromyalgia impact with higher scores indicating more impairment. The severity categorizations for the FIQ are: less than 40 (mild), 40-60 (moderate), and above 60 (severe).|Baseline|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.||Units on a scale||Standard Deviation|Mean
692161|NCT01432236|Primary|Mean NRS Pain Score at End of Period.|The daily pain diary consists of an 11-point numeric scale (NRS) ranging from 0 (“no pain”) to 10 (“worst possible pain”). Participants describe their pain during the past 24 hours by choosing the appropriate number between 0 and 10. The endpoint mean pain scores for Period 1 and Period 2 are defined as the mean of the last 7 non-missing daily diary pain ratings while taking study medication in the double-blind phase during Period 1 and Period 2, respectively.|End of each period, at Weeks 6 and 14|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.||Units on a scale||Standard Error|Least Squares Mean
692162|NCT01432015|Primary|Overall Complete Response Rate|no emetic episodes or rescue therapy following the initiation of chemotherapy|13 months|Study participants included adult, female patients with a histologically confirmed, newly diagnosed gynecologic cancer (e.g., epithelial ovarian, fallopian tube, primary peritoneal cancer or uterine cancer).||percentage of participants|||Number
692163|NCT01432015|Secondary|Impact on Daily Living Activities|Proportion of patients reporting no impact on daily living activities following initiation of chemotherapy|13 months|Study participants included adult, female patients with a histologically confirmed, newly diagnosed gynecologic cancer (e.g., epithelial ovarian, fallopian tube, primary peritoneal cancer or uterine cancer).||percentage of participants|||Number
692164|NCT01431989|Primary|First-order Rate Constant Associated With the Terminal Portion of the Curve (Kel)|This parameter is estimated via linear regression of time versus log concentration. It allows for the obtainment of estimates of T1/2 (T1/2=ln(2)/Kel) considering the schedule and the detection limits defined.|Collection points (hrs):0.00; 0.25; 0.50; 0.75; 1.00; 1.25; 1.50; 1.75; 2.00; 2.50; 3.00; 4.00; 5.00; 6.00; 8.00 evaluated in both periods: (Day 1 of Period 1 [Day 1 of study]; Day 1 of Period 2 [Day 15 of study])|Entire Study Population||1/hr||Standard Deviation|Mean
692165|NCT01431989|Primary|Terminal Half-life (T1/2_Kel)|T1/2_Kel is calculated by using the formula T1/2_Kel = Ln(2)/Kel.T1/2 is of particular use in measuring bioavailability, by measuring the elimination of the product.|Collection points (hrs):0.00; 0.25; 0.50; 0.75; 1.00; 1.25; 1.50; 1.75; 2.00; 2.50; 3.00; 4.00; 5.00; 6.00; 8.00 evaluated in both periods: (Day 1 of Period 1 [Day 1 of study]; Day 1 of Period 2 [Day 15 of study])|Entire Study Population||hr||Standard Deviation|Mean
692166|NCT01431989|Primary|Percentage of AUC0-inf That is Due to Extrapolation From the Time of the Last Measurable Concentration to Infinity (AUC%Extrapolation)|The percentage of AUC0-inf that is due to extrapolation from Tlast to infinity (AUC%Extrapolation) is calculated by using the formula AUC_%extrapolation = 100*(AUC0-inf minus AUC0-t)/AUC0-inf. The function of this parameter is to provide information about what percentage of the theoretical curve (AUC0-inf) was possible to determine experimentally (AUC0-t) Therefore, on average, it is expected that the residual area (AUCextrapolation) is not greater than 20%.|Collection points (hrs):0.00; 0.25; 0.50; 0.75; 1.00; 1.25; 1.50; 1.75; 2.00; 2.50; 3.00; 4.00; 5.00; 6.00; 8.00 evaluated in both periods: (Day 1 of Period 1 [Day 1 of study]; Day 1 of Period 2 [Day 15 of study])|Entire Study Population||percentage||Standard Deviation|Mean
692167|NCT01431989|Primary|Time of Maximum Observed Concentration (Tmax)|The time of maximum observed concentration (Tmax) is obtained directly from the plasma concentration curve of the drug by non-compartimental method. Tmax is of particular use in measuring bioavailability, by measuring the time at which the maximum concentration is achieved.|Collection points (hrs):0.00; 0.25; 0.50; 0.75; 1.00; 1.25; 1.50; 1.75; 2.00; 2.50; 3.00; 4.00; 5.00; 6.00; 8.00 evaluated in both periods: (Day 1 of Period 1 [Day 1 of study]; Day 1 of Period 2 [Day 15 of study])|Entire Study Population||hr||Standard Deviation|Mean
692168|NCT01431989|Primary|Area Under the Curve of Plasma Concentration of Drug From Time 0 (Zero) Extrapolated to Infinity (AUC0-inf)|Measurement of AUC0-inf is obtained directly from the plasma concentration curve of drug against time (non-compartmental method). AUC0-inf is calculated from time 0 (prior to administration of medication) extrapolated to infinity, by using the formula AUC0-inf = AUC0-t + Clast/Kel, where Clast is the last measurable concentration, and Kel is the first-order rate constant associated with the terminal portion of the curve. AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption.|Collection points (hrs):0.00; 0.25; 0.50; 0.75; 1.00; 1.25; 1.50; 1.75; 2.00; 2.50; 3.00; 4.00; 5.00; 6.00; 8.00 evaluated in both periods (Day 1 of Period 1[Day 1 of study]; Day 1 of Period 2 [Day 15 of study])|Entire Study Population||ng*hr/mL||Standard Deviation|Mean
692169|NCT01431989|Primary|Maximum Observed Concentration of Drug Through Time (Cmax)|Cmax is defined as the maximum or “peak” concentration of a drug observed after its administration. Cmax is one of the parameters of particular use in estimating the bioavailability of drugs, by measuring the total amount of drug absorbed. Measurement is obtained directly from the plasma concentration curve of the drug (non-compartmental method).|Collection points (hrs): 0.00; 0.25; 0.50; 0.75; 1.00; 1.25; 1.50; 1.75; 2.00; 2.50; 3.00; 4.00; 5.00; 6.00; 8.00 evaluated in both periods (Day 1 of Period 1 [Day 1 of study]; Day 1 of Period 2 [Day 15 of study])|Entire Study Population||ng/mL||Standard Deviation|Mean
692170|NCT01431989|Primary|Area Under the Curve of Plasma Concentration of Drug From Time 0 (Zero) to t (Last Measurable Concentration) (AUC0-t)|The area under the plot of plasma concentration of drug against time (non-compartmental method), after drug administration, is defined as the area under the curve (AUC). AUC0-t is calculated from time 0 (prior to administration of medication) to time t (the time of the last quantifiable concentration). AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. ng, nanograms; mL, milliliter.|Collection points (hours [hrs]): 0.00; 0.25; 0.50; 0.75; 1.00; 1.25; 1.50; 1.75; 2.00; 2.50; 3.00; 4.00; 5.00; 6.00; 8.00 evaluated in both periods (Day 1 of Period 1 [Day 1 of study]; Day 1 of Period 2 [Day 15 of study])|Entire Study Population||ng per hour per ml (ng*hr/mL)||Standard Deviation|Mean
692171|NCT01431976|Secondary|Number of Days With Seizure Episodes Per Week in the Extension Phase (ExP) Overall|Participants were asked to record the seizure codes, seizure duration, and their physical condition in a diary provided.|Extension Week 12 (Extension Visit 1 [Ext-V1], every 12 week after Ext-V1 and until withdrawal|FAS. Only those participants given the indicated dose of investigational product were analyzed.||Days||Standard Deviation|Mean
692172|NCT01431976|Secondary|Number of Days With Seizure Episodes Per Week in the Main Study Phase (Fixed Escalation Phase [FEP], Escalation Phase [EP], Maintenance Phase [MP]), and FEP+EP+MP)|Participants were asked to record the seizure codes, seizure duration, and their physical condition in a diary provided. Only participants data available at the analysis time point were analyzed (represented as n=X, X, X in category title)|Up to Study Week 50|FAS||Days||Standard Deviation|Mean
692173|NCT01431976|Secondary|Number of Participants Who Were Seizure Free as Confirmed by HV-clinical Signs at Each Assessment Point in the Extension Phase (ExP)|HV is an activation technique used to provoke seizures. Participants were instructed to breathe through their mouths deeply and rapidly (at a rate of approximately 20-25 breaths/minute) for 4 continuous minutes while sitting using a pin-wheel and were observed for clinical signs of seizures like impairment of consciousness; staring; eye enrollment; eye blinking; chewing movements; hand movement; other automatisms; atonic, tonic, clonic components; autonomic components; or any other signs. During the ExP, HV-clinical signs were assessed to confirm a status of seizure free. Only participants data available at the analysis time point were analyzed (represented as n=X, X, X in category title).|Extension Week 24 (Extension Visit 2 [Ext-V2], every 24 weeks after the Ext-V2 and until withdrawal|FAS. Only those participants given the indicated dose of investigational product were analyzed.||Participants|||Number
692174|NCT01431976|Secondary|Number of Participants Who Were Seizure Free as Confirmed by HV-EEG at Each Assessment Point in the Extension Phase (ExP)|EEG is a diagnostic test for epilepsy. The EEG machine records the brain’s electrical activity as a series of waveforms. HV is an activation technique used to provoke seizures during an EEG recording. An approximately 30-minute EEG with HV was performed on participants in a supine position. In the HV test, participants breathed through their mouths deeply and rapidly (at a rate of approximately 20-25 breaths/minute ) for 4 continuous minutes using a pin-wheel provided to them. Only participants data available at the analysis time point were analyzed (represented as n=X, X, X in category title).|Extension Week 12 (Extension Visit 1 [Ext-V1]), every 24 weeks after Ext-V1 and until withdrawal|FAS. Only those participants given the indicated dose of investigational product were analyzed.||Participants|||Number
692175|NCT01431976|Secondary|Number of Participants Who Were Seizure Free as Confirmed by HV-clinical Signs During Week 4 and Week 8 of the Maintenance Phase|HV is an activation technique used to provoke seizures. Participants were instructed to breathe through their mouths deeply and rapidly (at a rate of approximately 20-25 breaths/minute) for 4 continuous minutes while sitting using a pin-wheel and were observed for clinical signs of seizures like impairment of consciousness; staring; eye enrollment; eye blinking; chewing movements; hand movement; other automatisms; atonic, tonic, clonic components; autonomic components; or any other signs. During the Maintenace Phase, HV-clinical signs were assessed at Visit 1 (Week 4) and Visit 2 (Week 4).|Week 4 and Week 8 of the Maintenance Phase (up to Study Weeks 42 and 46, respectively)|FAS. Only those participants who were dosed with investigational product at the indicated time points were analyzed.||Participants|||Number
692176|NCT01431976|Secondary|Number of Participants Who Were Seizure Free as Confirmed by HV-clinical Signs at Each Dose During the Escalation Phase|HV is an activation technique used to provoke seizures. Participants were instructed to breathe through their mouths deeply and rapidly (at a rate of approximately 20-25 breaths/minute) for 4 continuous minutes while sitting using a pin-wheel and were observed for clinical signs of seizures like impairment of consciousness; staring; eye enrollment; eye blinking; chewing movements; hand movement; other automatisms; atonic, tonic, clonic components; autonomic components; or any other signs. During the Escalation Phase, HV-clinical signs were assessed to confirm a status of seizure free. Only participants data available at the analysis time point were analyzed (represented as n=X, X, X in category title).|Up to Study Week 49|FAS. Only those participants given the indicated dose of investigational product were analyzed.||Participants|||Number
692320|NCT01430624|Primary|Amount of Alcohol Use|estimated number of drinks during the 14 days prior to each follow-up assessment|14 days prior to 6 week, 3 month, 6 month follow-up|1 participant with missing data at 6 week follow-up||Drinks||Standard Deviation|Mean
692178|NCT01431976|Primary|Number of Participants Who Were Seizure Free as Confirmed by Hyperventilation (HV)-Electroencephalography (EEG) at the End of the Maintenance Phase (MP)|EEG is a diagnostic test for epilepsy. The EEG machine records the brain’s electrical activity as a series of waveforms. HV is an activation technique used to provoke seizures during an EEG recording. An approximately 30-minute EEG with HV was performed on participants in a supine position. In the HV test, participants breathed through their mouths deeply and rapidly (at a rate of approximately 20-25 breaths/minute) for 4 continuous minutes using a pin-wheel provided to them.|Week 12 of the Maintenance Phase (up to Study Week 50)|Full Analysis Set (FAS): all participants who took at least one dose of investigational product and contributed data to at least one efficacy measure after the first dosing of investigational product||Participants|||Number
692179|NCT01431963|Secondary|Time to the First Seizure in the Maintenance Phase (Across Seizure Types and by Seizure Type)|The time to the first seizure in the Maintenance Phase is measured at the time the first seizure occurred in the Maintenance Phase. Seizure types are defined as: ALL=any type of seizure; A: simple partial seizures, B: complex partial seizures; C: partial seizures evolving to secondary generation seizures; D5: tonic-clonic seizures. Simple partial seizures are seizures that affect only a small region of the brain, often the temporal lobes or hippocampi. Complex partial seizures are epileptic seizures that are associated with bilateral cerebral hemisphere involvement and cause impairment of awareness or responsiveness. Partial seizures evolving to secondary generation seizures are seizures that start as partial seizures, then spread to include the entire brain. Tonic–clonic seizures are a type of generalized seizure that affects the entire brain.|Weeks 7 to 30|FAS. Only those participants available at the specified time point were analyzed.||Days||Standard Error|Mean
692180|NCT01431963|Secondary|Time to Withdrawal/Dropout From the Study (Across Seizure Types and by Seizure Type in Past 6 Months in the Escalation and Maintenance Phases)|Time to withdrawal is defined as the time from the start of treatment until withdrawal from the study. Seizure types are defined as: ALL=any type of seizure; A: simple partial seizures, B: complex partial seizures; C: partial seizures evolving to secondary generation seizures; D5: tonic-clonic seizures. Simple partial seizures are seizures which affect only a small region of the brain, often the temporal lobes or hippocampi. Simple partial seizures are seizures that affect only a small region of the brain, often the temporal lobes or hippocampi. Complex partial seizures are epileptic seizures that are associated with bilateral cerebral hemisphere involvement and cause impairment of awareness or responsiveness. Partial seizures evolving to secondary generation seizures are seizures that start as partial seizures, then spread to include the entire brain. Tonic–clonic seizures are a type of generalized seizure that affects the entire brain.|up to Week 30|FAS. Only those participants available at the specified time point were analyzed.||Days||Standard Error|Mean
692181|NCT01431963|Primary|Number of Participants Who Were Seizure Free in the Maintenance Phase (Across Seizure Types and by Seizure Type Within 6 Months Prior to the Start of the Study)|Participants were considered to be seizure free if they did not report any seizures during the Maintenance Phase. Seizure types are defined as: ALL=any type of seizure; A: simple partial seizures, B: complex partial seizures; C: partial seizures evolving to secondary generation seizures; D5: tonic-clonic seizures. Simple partial seizures are seizures that affect only a small region of the brain, often the temporal lobes or hippocampi. Complex partial seizures are epileptic seizures that are associated with bilateral cerebral hemisphere involvement and cause impairment of awareness or responsiveness. Partial seizures evolving to secondary generation seizures are seizures that start as partial seizures, then spread to include the entire brain. Tonic–clonic seizures are a type of generalized seizure that affects the entire brain.|Weeks 7 to 30|Full Analysis Set (FAS): all participants in the Safety Population (SP) who provided at least one set of efficacy data after the first dosing of investigational product. The SP is comprised of all participants who had taken at least one dose of investigational product. Only those participants available at the specified time point were analyzed.||participants|||Number
692182|NCT01431950|Secondary|Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods Over the 24-week Treatment Period|Asthma symptoms were recorded in a daily eDairy by the participants every day in the morning and evening before taking any rescue or study medication and before the peak expiratory flow measurement. A 24-hour period in which a participant’s responses to both the morning and evening assessments indicated no symptoms was considered to be symptom free. A 24-hour period was considered as missing if both the day time and night time data were missing or if one was symptom-free but the other was missing. The Baseline value was the average of the values of the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|From Baseline up to Week 24|ITT Population. Only those participants available at the specified time points were analyzed.||Percentage of symptom-free 24-hr periods||Standard Error|Least Squares Mean
692183|NCT01431950|Secondary|Change From Baseline in Daily Morning (AM) PEF Averaged Over the 24-week Treatment Period|PEF is a measure of lung function and is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning and evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline (defined as the average of the values of the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily AM PEF over the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|From Baseline up to Week 24|ITT Population. Only those participants available at the specified time points were analyzed.||L/min||Standard Error|Least Squares Mean
692184|NCT01431950|Secondary|Change From Baseline in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 24-week Treatment Period|PEF is a measure of lung function and is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning and evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline (defined as the average of the values of the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily trough PM PEF over the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|From Baseline up to Week 24|ITT Population. Only those participants available at the specified time points were analyzed.||Liters/minute (L/min)||Standard Error|Least Squares Mean
692185|NCT01431950|Secondary|Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods Over the 24-week Treatment Period|The number of inhalations of rescue bronchodilator, albuterol/salbutamol inhalation aerosol, used during the day and night was recorded by the participants in a daily electronic diary (eDiary). A 24-hour period in which a participant’s responses to both the morning and evening assessments indicated no use of rescue medication was considered to be rescue free. A 24-hour period was considered as missing if both day time and night time values were missing or if one of the day time or night time values were missing and the other value indicated no use of rescue medication. The Baseline value is the average of the values over the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|From Baseline up to Week 24|ITT Population. Only those participants available at the specified time points were analyzed.||Percentage of rescue-free 24-hr periods||Standard Error|Least Squares Mean
692186|NCT01431950|Primary|Change From Baseline in Clinic Visit Evening (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 24-week Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Evening clinic visit FEV1 is defined as the clinic visit (pre-bronchodilator and pre-dose) FEV1 measurement taken at the Week 24 clinic visit. Pre-dose and pre-rescue albuterol/salbutamol trough FEV1 were measured electronically by spirometry in the evening at the Baseline through Week 24 clinic visits. The highest of 3 technically acceptable measurements was recorded. Baseline was the pre-dose value obtained at Visit 2. Change from Baseline was calculated as the Week 24 value minus the Baseline value. Analysis was performed using analysis of covariance (ANCOVA) with covariates of Baseline, region, sex, age, and treatment. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing, pre-dose, post-Baseline on-treatment measurement at scheduled clinic visits was used to impute the missing value.|Baseline and Week 24|Intent-to-Treat (ITT) Population: all participants (par.) randomized to treatment who received >=1 dose of study medication, except for the par. of one investigator (excluded after good clinical practice [GCP] issues identified during a site audit). Only those par. with non-missing covariates and post-Baseline FEV1 data were analyzed.||Liters||Standard Error|Least Squares Mean
692187|NCT01431846|Primary|See Primary Outcome Description Below|Follow up appointment within 2 weeks of discharge back to their primary care providers at a primary care facility from a tertiary referral center.|Within 2 weeks of discharge|||participants|||Number
692188|NCT01431755|Secondary|Number of Subjects Reporting Adverse Event|"Adverse Events (AEs) were collected by open questioning, information obtained from signs and symptoms detected during examination, observed by the study personnel or spontaneous reports from the subjects.
All subjects were injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek."|Up to 12 months|Safety population, 54 subjects.||participants|||Number
692189|NCT01431755|Secondary|Number of Subjects Reporting at Least 1 Diary Complaint Related to the Cheek Treated With Restylane SubQ and Restylane SubQ Lidocaine Respectively After Initial Treatment.|A subject diary was completed for 14 days following the initial treatment and the optional re-treatment at the 3-month visit. Each subject was asked to record the presence of bruising, redness, swelling, pain, tenderness and itching.|14 days|Safety Population. 54/54 subjects.||participants|||Number
692190|NCT01431755|Secondary|Percentage of Subjects With at Least One Step Improvement on Medicis Midface Volume Scale (MMVS) at 2 Weeks|The severity of midface volume loss or midface contour deficiency was assessed by the investigators using a 4-graded scale, Medicis Midface Volume Scale -MMVS (1, fairly full; 2, mild loss of fullness; 3, moderate loss, slight hollowing; and 4, substantial loss, clearly apparent hollowing). Each score were exemplified by photographic images on the scale. A one grade decrease in score from screening was defined as a treatment success/improvement.The efficacy in terms of Medicis Midface Volume Scale (MMVS) was assessed by the Investigator per treatment group. The two cheeks were evaluated separately. MMVS was assessed at the time points 2 weeks, 3 months, 2 weeks after re-treatment and 6, 9 and 12 months after first treatment.|2 weeks|Intention to treat. 54/54 subjects||percentage of participants||95% Confidence Interval|Number
692191|NCT01431755|Secondary|Percentage of Improved Subjects at 2 Weeks After Treatment as Assessed by Use of Global Esthetic Improvement Scale (GEIS)|Esthetic improvement was evaluated by using Global Esthetic Improvement Scale. GEIS was evaluated by comparing current photos with pre-treatment photos and using a 5-graded scale (worse/no change/somewhat improved/much improved/very much improved). A clinically significant global esthetic improvement was defined as a score of somewhat improved, much improved or very much improved. GEIS was assessed by the Investigator and the subject. Each cheek/study product was evaluated separately. GEIS was assessed at the time points 2 weeks, 3 months, 2 weeks after re-treatment and 6, 9 and 12 months after first treatment.|2 weeks|Intention to treat. 54/54 subjects||percentage of participants||95% Confidence Interval|Number
692192|NCT01431755|Secondary|Subject Pain Assessment by Visual Analogue Scale (VAS) 15 and 120 Minutes After Treatment.|"Pain was assessed during the first 2 hours after the initial injection of the study products using a 100 mm VAS. The endpoints of the scale were no pain (0 mm) and worst possible pain (100 mm). Pain was assessed at the time points 15, 30, 60, 90 and 120 minutes after injection."|15 and 120 minutes|Intention to treat. 54/54 subjects||units on a scale||Standard Deviation|Mean
692193|NCT01431755|Primary|Percentage of Subjects Who Assessed Treatment With Restylane SubQ Lidocaine as Least Painful.|When injection of both cheeks was completed, the subject was asked which treatment was least painful (right cheek/left cheek/both cheeks alike).|When injection of both cheeks were completed|Intention to treat. 54/54 subjects||percentage of participants||95% Confidence Interval|Number
692194|NCT01431716|Other Pre-specified|Number of Participants With Adverse Events Leading to Discontinuation of Study Drug From Baseline to EOT.|Adverse events that led to discontinuation of study drug from the start of study treatment until the end of study treatment were recorded.|Approximately 3 months|All-treated set.||participants|||Number
692209|NCT01431521|Primary|Number of Participants Who Discontinued Study Drug Due to an AE|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to 4 weeks|The AST Population consists of all participants who received at least one dose of the study drug.||Participants|||Number
692195|NCT01431716|Other Pre-specified|Change in Global Satisfaction Score of the Abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9) From Baseline to EOT.|Patients were required to complete the TSQM-9 questionnaire at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT. The TSQM-9 is a validated instrument to assess patients' satisfaction with medication, including a three question global satisfaction scale. The TSQM-9 domain scores range from 0 to 100 with higher scores representing higher satisfaction on that domain.|Approximately 3 months|All-treated set who had both a baseline and an EOT assessment.||units on a scale||Standard Deviation|Mean
692196|NCT01431716|Other Pre-specified|Change in Convenience Score of the Abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9) From Baseline to EOT.|Patients were required to complete the TSQM-9 questionnaire at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT. The TSQM-9 is a validated instrument to assess patients' satisfaction with medication, including a three question convenience scale. The TSQM-9 domain scores range from 0 to 100 with higher scores representing higher satisfaction on that domain.|Approximately 3 months|All-treated set who had both a baseline and an EOT assessment.||units on a scale||Standard Deviation|Mean
692197|NCT01431716|Other Pre-specified|Change in Effectiveness Score of the Abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9) From Baseline to EOT.|Patients were required to complete the TSQM-9 questionnaire at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT. The TSQM-9 is a validated instrument to assess patients' satisfaction with medication, including a three question effectiveness scale. The TSQM-9 domain scores range from 0 to 100 with higher scores representing higher satisfaction on that domain.|Approximately 3 months|All-treated set who had both a baseline and an EOT assessment.||units on a scale||Standard Deviation|Mean
692198|NCT01431716|Other Pre-specified|Change in N-terminal Pro-B-type Natriuretic Peptide (NT proBNP) From Baseline to EOT.|Blood sampling for NT proBNP was performed at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.|Approximately 3 months|All-treated set who had both a baseline and an EOT assessment.||ng/L||Standard Deviation|Mean
692199|NCT01431716|Other Pre-specified|Number of Participants With Improved, No Change, or Worsening of New York Heart Association Functional Class (NYHA FC) From Baseline to EOT.|NYHA FC was assessed at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT. Disease severity was assessed by NYHA classification of pulmonary arterial hypertension criteria: Class I: no limitation of physical activity (PA). Ordinary PA: no undue dyspnea/fatigue, chest pain, near syncope. Class II: slight limitation of PA. Comfortable at rest. Ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class III: marked limitation of PA. Comfortable at rest. Less than ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class IV: inability to carry out PA without symptoms. Right heart failure. Dyspnea/fatigue may even have been present at rest. Discomfort increased by any PA.|Approximately 3 months|All-treated set who had both a baseline and an EOT assessment.||participants|||Number
692200|NCT01431716|Other Pre-specified|Change in Borg Dyspnea Score From Baseline to EOT.|"The Borg dyspnea score was assessed at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT. The Borg scale is a category-ratio scale, commonly used to evaluate the effects of exercise on dyspnea. The original and modified scales have ratio properties ranging from 0 = nothing at all to 10 = very, very severe, with descriptors from 0 to 10. Descriptors have been modified by others so that 10 has been labelled extremely severe, or the worst possible dyspnea imaginable."|Approximately 3 months|All-treated set who had both a baseline and an EOT assessment.||units on a scale||Standard Deviation|Mean
692201|NCT01431716|Primary|Change in Mean Cardiac Index From Baseline to End of Treatment (EOT).|Right heart catheterization was performed for cardiac hemodynamic assessment at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.|Approximately 3 months|All treated set without imputation for missing values||L/min/m^2||Standard Deviation|Mean
692202|NCT01431716|Primary|Change in Pulmonary Capillary Wedge Pressure From Baseline to End of Treatment (EOT).|Right heart catheterization was performed for cardiac hemodynamic assessment at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.|Approximately 3 months|All treated set without imputation for missing values. Data was missing for 5 patients.||mmHg||Standard Deviation|Mean
692203|NCT01431716|Primary|Change in Mean Right Atrial Pressure From Baseline to End of Treatment (EOT).|Right heart catheterization was performed for cardiac hemodynamic assessment at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.|Approximately 3 months|All treated set without imputation for missing values||mmHg||Standard Deviation|Mean
692204|NCT01431716|Primary|Change in Mean Pulmonary Arterial Pressure From Baseline to End of Treatment (EOT).|Right heart catheterization was performed for cardiac hemodynamic assessment at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.|Approximately 3 months|All treated set without imputation for missing values||mmHg||Standard Deviation|Mean
692205|NCT01431716|Primary|Change in Total Pulmonary Resistance From Baseline to End of Treatment (EOT).|Right heart catheterization was performed for cardiac hemodynamic assessment at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.|Approximately 3 months|All treated set without imputation for missing values||dyn/sec/cm^5||Standard Deviation|Mean
692206|NCT01431716|Other Pre-specified|Change in 6-minute Walk Distance (6MWD) From Baseline to EOT.|The 6MWD was assessed at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT. The 6-minute walk test is a non-encouraged test that measures the distance walked for the duration of 6 min.|Approximately 3 months|All-treated set who had both a baseline and an EOT assessment.||m||Standard Deviation|Mean
692207|NCT01431716|Primary|Change in Pulmonary Vascular Resistance From Baseline to End of Treatment (EOT).|Right heart catheterization was performed for cardiac hemodynamic assessment at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.|Approximately 3 months|All treated set without imputation for missing values. Data was missing for 5 patients.||dyn/sec/cm^5||Standard Deviation|Mean
692208|NCT01431703|Primary|Accuracy, Sensitivity, and Specificity for Differentiating Neoplastic and Non-neoplastic Lesions||For this training, patients were consecutively enrolled until a total of 45 target and non-target lesions were obtained.|||percentage of lesions||95% Confidence Interval|Number
692321|NCT01430624|Secondary|Any Other Illicit Drug Use|Any reported use of cocaine or other illicit drugs other than marijuana in the 14 days prior to follow-up|14 days prior to 6 week, 3 month, 6 month follow-up|||participants|||Number
692211|NCT01431521|Secondary|Percent Change From Baseline Aspartate Transaminase (AST)|Hepatic steatosis is not uncommonly associated with mild elevations in serum transaminases, including AST, and these elevations may be a marker of more advanced hepatic disease. Serum transaminases were monitored at baseline and once weekly for the duration of the study to permit a better understanding of the time course of potential improvement in hepatic inflammation during the course of this short study.|Baseline and Week 4|The AST Population consists of all participants who received at least one dose of the study drug. One participant in the Placebo group did not have AST data for Day 28.||Percent change||95% Confidence Interval|Least Squares Mean
692212|NCT01431521|Secondary|Percent Change From Baseline in Alanine Transaminase (ALT)|Hepatic steatosis is not uncommonly associated with mild elevations in serum transaminases, specifically ALT, and these elevations may be a marker of more advanced hepatic disease. Serum transaminases were monitored at baseline and once weekly for the duration of the study to permit a better understanding of the time course of potential improvement in hepatic inflammation during the course of this short study.|Baseline and Week 4|The AST Population consists of all participants who received at least one dose of the study drug. One participant in the Placebo group did not have ALT data for Day 28.||Percent change||95% Confidence Interval|Least Squares Mean
692213|NCT01431521|Primary|Percent Change From Baseline in Hepatic Fat|Hepatic fat content was assessed via magnetic resonance imaging (MRI) prior to first dose administration and following 4 weeks of treatment. Percent change in hepatic fat fraction from baseline was calculated for each of the 9 liver regions separately and then these were averaged to calculate overall percent change from baseline for each participant.|Baseline and Week 4|Per-Protocol (PP) Population consists of those participants who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model.||Percent change||95% Confidence Interval|Least Squares Mean
692214|NCT01431508|Primary|Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12|Participants with SiDBP of 95-115 mmHg at the end of Baseline had SiDBP measured after 12 weeks of treatment.|At Baseline and Week 12|Intention-to-Treat||mm Hg||Standard Deviation|Mean
692215|NCT01431391|Secondary|Percentage of Participants With Immune Response As Evaluated by IFN-γ ELISPOT Specific for PA2024|A participant was considered to have an immune response it the post-baseline PA2024-specific IFN-g ELISPOT count was >18|Month 24|The immune response population was defined as all randomized subjects who received 3 infusions of sipuleucel-T.||percentage of participants|||Number
692216|NCT01431391|Primary|Immune Response at Month 24 as Evaluated by IFN-γ ELISPOT Specific for PA2024|Immune response at month 24 as evaluated by IFN-γ ELISPOT specific for PA2024 following sipuleucel-T/ADT treatment regimens to determine if order of administration impacted immune response.|PA2024 ELISPOT counts at Month 24|The immune response population was defined as all randomized subjects who received 3 infusions of sipuleucel-T.||IFN-γ ELISPOT (per 300,000 PBMC)||Standard Error|Mean
692217|NCT01431339|Secondary|Clinical Status|Compare the clinical efficacy at the short term follow-up visit of dalbavancin to the comparator regimen based on lesion size, local signs temperature and receipt of other therapy|Follow-Up Visit (day 28)|Clinical Evaluable Population based on certain inclusion/exclusion criteria, length of study therapy, concomitant antibacterials, concomitant surgical procedure and non-missing data.||participants|||Number
692218|NCT01431339|Secondary|>= 20% Reduction in Lesion Area|Clinical response at 48-72 hours post study drug initiation, based on measurements of acute bacterial skin and skin structure infections (ABSSSI) lesion size|48-72 hours after the initiation of study therapy|The ITT population consisted of all randomly assigned patients regardless of whether or not they received study drug.||participants|||Number
692219|NCT01431339|Secondary|Clinical Status|Compare the clinical efficacy at end of treatment visit of dalbavancin to the comparator regimen based on lesion size, local signs, temperature and receipt of other therapy|End of Treatment Visit (Day 14-15)|Clinical Evaluable Population based on certain inclusion/exclusion criteria, length of study therapy, concomitant antibacterials, concomitant surgical procedure and non-missing data.||participants|||Number
692220|NCT01431339|Primary|Early Clinical Efficacy|Clinical response at 48-72 hours post study drug initiation, based on measurements of acute bacterial skin and skin structure infections (ABSSSI) lesion size and temperature|After 48-72 hours of therapy|The ITT population consisted of all randomly assigned patients regardless of whether or not they received study drug.||participants|||Number
692221|NCT01431300|Secondary|Quantitative Analysis Noise Ratios|"Signal-to-noise and contrast-to-noise ratios were calculated for each central venous segment, to determine the magnitude of difference in each of the three administered doses. The ratio's were calculated as follows:
Signal-to-noise ratio: signal intensity of vessel segment / standard deviation of signal intensity of the background.
Contrast-to-noise ratio = (signal intensity of vessel segment minus signal intensity of adjacent muscle) / standard deviation of signal intensity of the background."|14 weeks|||ratio||Standard Deviation|Mean
692222|NCT01431300|Primary|Imaging Quality Score|"Two radiologists assessed imaging quality of each central venous segment for each patient, in order to compare imaging quality between each of the three doses administered. The visualization score for each venous segments was as follows:
poor / nondiagnostic
adequate
good
excellent"|14 weeks|||Units on a visualization score scale||Full Range|Mean
692223|NCT01431287|Secondary|Mahler Transitional Dyspnoea Index (TDI) Focal Score on Day 365 From the Two Twin Trials, Present 1237.6 (NCT01431287) and 1237.5 (NCT01431274)|"Mahler TDI focal score on Day 365 From the two twin trials, present 1237.6 (NCT01431287) and 1237.5 (NCT01431274).
The Mahler Dyspnoea questionnaire is an instrument which measures change from the baseline state The TDI focal score was used to measure the effect of Tio+Olo FDC on patients' dyspnoea after 24 weeks of treatment (Day 169). The focal score is the sum of the subscale scores for Functional Impairment, Magnitude of Effort and Magnitude of Task. Scores for each subscale range from -3 to 3 so that the Focal score ranges from -9 to 9. For all subscale scores and the Focal score a higher value indicates a better outcome.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group."|Day 365|FAS (day 365). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||points on a scale||Standard Error|Least Squares Mean
692322|NCT01430624|Primary|Cigarettes (Estimated Number)|quantity in 14 days prior to 6 week, 3 month and 6 month follow-up|14 days preceding 6 week, 3 month and 6 month follow-up|1 participant missing 6 week cigarette smoking information||cigarettes||Standard Error|Mean
692224|NCT01431287|Secondary|Mahler Transitional Dyspnoea Index (TDI) Focal Score on Day 85 From the Two Twin Trials, Present 1237.6 (NCT01431287) and 1237.5 (NCT01431274)|"Mahler TDI focal score on Day 85 From the two twin trials, present 1237.6 (NCT01431287) and 1237.5 (NCT01431274).
The Mahler Dyspnoea questionnaire is an instrument which measures change from the baseline state The TDI focal score was used to measure the effect of Tio+Olo FDC on patients' dyspnoea after 24 weeks of treatment (Day 169). The focal score is the sum of the subscale scores for Functional Impairment, Magnitude of Effort and Magnitude of Task. Scores for each subscale range from -3 to 3 so that the Focal score ranges from -9 to 9. For all subscale scores and the Focal score a higher value indicates a better outcome.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group."|Day 85|FAS (day 85). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||points on a scale||Standard Error|Least Squares Mean
692225|NCT01431287|Secondary|Mahler Transitional Dyspnoea Index (TDI) Focal Score on Day 43 From the Two Twin Trials, Present 1237.6 (NCT01431287) and 1237.5 (NCT01431274)|"Mahler TDI focal score on Day 43 From the two twin trials, present 1237.6 (NCT01431287) and 1237.5 (NCT01431274).
The Mahler Dyspnoea questionnaire is an instrument which measures change from the baseline state The TDI focal score was used to measure the effect of Tio+Olo FDC on patients' dyspnoea after 24 weeks of treatment (Day 169). The focal score is the sum of the subscale scores for Functional Impairment, Magnitude of Effort and Magnitude of Task. Scores for each subscale range from -3 to 3 so that the Focal score ranges from -9 to 9. For all subscale scores and the Focal score a higher value indicates a better outcome.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group."|Day 43|FAS (day 43). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||points on a scale||Standard Error|Least Squares Mean
692226|NCT01431287|Secondary|Saint George’s Respiratory Questionnaire (SGRQ) Total Score on Day 365 From the Two Twin Trials, Present 1237.6 (NCT01431287) and 1237.5 (NCT01431274)|"The SGRQ is designed to measure health impairment in patients with COPD. It is divided into 2 parts: part 1 produces the symptoms score, and part 2 the activity and impacts scores. A total score is also produced. Each subscale score is the sum of the weights for the items in the subscale as a percent of the sum of the weights for a patient in the worst possible condition. The total score uses the same calculation except that the weights are summed over the entire questionnaire. The individual subscales as well as the total score can range from 0 to 100 with a lower score denoting a better health status.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group."|Day 365|FAS (day 365). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||points on a scale||Standard Error|Least Squares Mean
692227|NCT01431287|Secondary|Saint George’s Respiratory Questionnaire (SGRQ) Total Score on Day 85 From the Two Twin Trials, Present 1237.6 (NCT01431287) and 1237.5 (NCT01431274)|"The SGRQ is designed to measure health impairment in patients with COPD. It is divided into 2 parts: part 1 produces the symptoms score, and part 2 the activity and impacts scores. A total score is also produced. Each subscale score is the sum of the weights for the items in the subscale as a percent of the sum of the weights for a patient in the worst possible condition. The total score uses the same calculation except that the weights are summed over the entire questionnaire. The individual subscales as well as the total score can range from 0 to 100 with a lower score denoting a better health status.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group."|Day 85|FAS (day 85). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||points on a scale||Standard Error|Least Squares Mean
692228|NCT01431287|Secondary|FVC AUC(0-24h) Response in Sub-set of Patients With 12-hour PFTs on Day 169 From the Two Twin Trials, Present 1237.6 (NCT01431287) and 1237.5 (NCT01431274)|"FVC AUC(0-24h) was calculated as the area under the FVC- time curve from 0 to 24 h post-dose using the trapezoidal rule, divided by the duration (24 h) to report in litres.
FVC AUC(0-24h) response was defined as FVC AUC(0-24h) minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).
The adjusted mean (SE) were obtained from fitting an ANCOVA model with categorical effect of treatment and baseline as covariate.
Number of participants analyzed are the number of patients contributing to the ANCOVA model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h, 23 h, 23 h and 50 min post-dose on Day 169|12-hr PFT set||Litres||Standard Error|Least Squares Mean
692229|NCT01431287|Secondary|FVC AUC(0-12h) Response in Sub-set of Patients With 12-hour PFTs on Day 169 From Two Twin Trials, Present 1237.6 (NCT01431287) and 1237.5 (NCT01431274)|"FVC AUC(0-12h) was calculated as the area under the FVC- time curve from 0 to 12 h post-dose using the trapezoidal rule, divided by the duration (12 h) to report in litres.
FVC AUC(0-12h) response was defined as FVC AUC(0-12h) minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).
The adjusted mean (SE) were obtained from fitting an ANCOVA model with categorical effect of treatment and baseline as covariate. Number of participants analyzed are the number of patients contributing to the ANCOVA model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h post-dose on Day 169|12-hr PFT set||Litres||Standard Error|Least Squares Mean
692300|NCT01431014|Primary|Effect of Perioperative Steroid for the Postoperative Swelling After Orthognathic Surgery|Measure of facial swelling will be performed using 3-dimensional photogrammetry. The 3d photo acquisition is non-invasive without radiation concern. The images will be taken before and after surgery to measure and compare the degree of facial swelling. Side effects from the steroid use are expected to be low under normal clinical dosage, but will also be monitored. Symptoms of wound infection, psychosis, and prolonged wound healing will be studied. There should be no long term complication, since the steroid use is one single dose.|1 year|||ml||Standard Deviation|Mean
692230|NCT01431287|Secondary|FEV1 AUC(0-24h) Response in Sub-set of Patients With 12-hour PFTs on Day 169 From the Two Twin Trials, Present 1237.6 (NCT01431287) and 1237.5 (NCT01431274)|"FEV1 AUC(0-24h) was calculated as the area under the FEV1- time curve from 0 to 24 h post-dose using the trapezoidal rule, divided by the duration (24 h) to report in litres. FEV1 AUC(0-24h) response was defined as FEV1 AUC(0-24h) minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).
The adjusted mean (SE) were obtained from fitting an ANCOVA model with categorical effect of treatment and baseline as covariate.
Number of participants analyzed are the number of patients contributing to the ANCOVA model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h, 23 h, 23 h and 50 min post-dose on Day 169|12−hr PFT set||Litres||Standard Error|Least Squares Mean
692231|NCT01431287|Secondary|FEV1 AUC(0-12h) Response in Sub-set of Patients With 12-hour Pulmonary Function Test (PFT) on Day 169 From the Two Twin Trials, Present 1237.6 (NCT01431287) and 1237.5 (NCT01431274)|"FEV1 AUC(0-12h) was calculated as the area under the FEV1- time curve from 0 to 12 h post-dose using the trapezoidal rule, divided by the duration (12 h) to report in litres.
FEV1 AUC(0-12h) response was defined as FEV1 AUC(0-12h) minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).
The adjusted mean (SE) were obtained from fitting an ANCOVA model with categorical effect of treatment and baseline as covariate.
Number of participants analyzed are the number of patients contributing to the ANCOVA model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h post-dose on Day 169|12 hr PFT set: All patients who have given Informed Consent for the 12-hour PFT testing and had any spirometry measurement after 3-hour and before or at 12-hours post-dose on Days 169 and 170.||Litres||Standard Error|Least Squares Mean
692232|NCT01431287|Secondary|Trough FVC Response on Day 365|"Trough FVC was defined as the FVC value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.
Trough FVC response was defined as trough FVC minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group.
The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and on day 365|FAS (day 365). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Least Squares Mean
692233|NCT01431287|Secondary|Trough FVC Response on Day 170|"Trough FVC was defined as the FVC value at the end of the dosing interval (24 hours) and was calculated as the mean of the 2 FVC measurements performed at 23h and at 23h 50 min after inhalation of study medication at the clinic visit on the previous day.
Trough FVC response was defined as trough FVC minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).
The adjusted means (SE) were obtained from fitting an MMRM including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 23h and at 23h 50 min after inhalation of study medication on day 170|FAS. Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Least Squares Mean
692234|NCT01431287|Secondary|Trough FVC Response on Day 85|"Trough FVC was defined as the FVC value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.
Trough FVC response was defined as trough FVC minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group.
The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and on day 85|FAS (day 85). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Least Squares Mean
692235|NCT01431287|Secondary|Trough FVC Response on Day 43|"Trough FVC was defined as the FVC value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.
Trough FVC response was defined as trough FVC minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group.
The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 10 min pre-dose on day 43|FAS (day 43). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Least Squares Mean
692236|NCT01431287|Secondary|Trough FVC Response on Day 15|"Trough FVC was defined as the FVC value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.
Trough FVC response was defined as trough FVC minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group.
The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 10 min pre-dose on day 15|FAS (day 15). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Least Squares Mean
692237|NCT01431287|Secondary|Forced Vital Capacity (FVC) AUC(0-3h) Response on Day 365|"FVC AUC(0-3h) was calculated as the area under the FVC- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres.
FVC AUC(0-3h) response was defined as FVC AUC(0-3h) minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).
The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 365 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 365|FAS (day 365). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Median
692238|NCT01431287|Secondary|Forced Vital Capacity (FVC) AUC(0-3h) Response on Day 169|"FVC AUC(0-3h) was calculated as the area under the FVC- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres.
FVC AUC(0-3h) response was defined as FVC AUC(0-3h) minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).
The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 169|FAS (day 169). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Median
692239|NCT01431287|Secondary|Forced Vital Capacity (FVC) AUC(0-3h) Response on Day 85|"FVC AUC(0-3h) was calculated as the area under the FVC- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres.
FVC AUC(0-3h) response was defined as FVC AUC(0-3h) minus baseline FVC.Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).
The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 85 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 85|FAS (day 85). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Median
692240|NCT01431287|Secondary|Forced Vital Capacity (FVC) AUC(0-3h) Response on Day 1|"FVC AUC(0-3h) was calculated as the area under the FVC- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres.
FVC AUC(0-3h) response was defined as FVC AUC(0-3h) minus baseline FVC.Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).
The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on the first day of randomized treatment|FAS (day 1). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Median
692301|NCT01430819|Other Pre-specified|Geometric Mean of Titer Ratios (GMTR) of Antibodies to Vaccine Antigens Before and Following Vaccination With Either Fluzone® or Fluzone® High-Dose Vaccine.|"Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay.
Geometric mean of titer ratio is the geometric mean of the individual post-vaccination/pre-vaccination titer ratios."|Day 21 post-vaccination|Geometric mean of titer ratios of antibodies against Influenza vaccine antigens were determined in all enrolled and vaccinated participants, per-protocol population||Titers||95% Confidence Interval|Geometric Mean
692241|NCT01431287|Secondary|Trough FEV1 Response on Day 365|"Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.
Trough FEV1 response was defined as trough FEV1 minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 1 hr and 10 min pre-dose on day 365|FAS (day 365). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Least Squares Mean
692242|NCT01431287|Secondary|Trough FEV1 Response on Day 169|"Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.
Trough FEV1 response was defined as trough FEV1 minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 1hr and 10 min pre-dose on day 169|FAS (day 169). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Least Squares Mean
692243|NCT01431287|Secondary|Trough FEV1 Response on Day 85|"Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.
Trough FEV1 response was defined as trough FEV1 minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 1hr and 10 min pre-dose on day 85|FAS (day 85). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Least Squares Mean
692244|NCT01431287|Secondary|Trough FEV1 Response on Day 43|"Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.
Trough FEV1 response was defined as trough FEV1 minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 10 min pre-dose on day 43|FAS (day 43). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Least Squares Mean
692245|NCT01431287|Secondary|Trough FEV1 Response on Day 15|"Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.
Trough FEV1 response was defined as trough FEV1 minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 10 min pre-dose on day 15|FAS (day 15). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Least Squares Mean
692246|NCT01431287|Secondary|FEV1 AUC(0-3h) Response on Day 365|"FEV1 AUC(0-3h) was calculated as the area under the FEV1- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres.
FEV1 AUC(0-3h) response was defined as FEV1 AUC(0-3h) minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.
The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 365 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 365|FAS (on day 365). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Least Squares Mean
692247|NCT01431287|Secondary|FEV1 AUC(0-3h) Response on Day 85|"FEV1 AUC(0-3h) was calculated as the area under the FEV1- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres.
FEV1 AUC(0-3h) response was defined as FEV1 AUC(0-3h) minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.
The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 85 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 85|FAS (on day 85). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Least Squares Mean
692248|NCT01431287|Secondary|FEV1 AUC(0-3h) Response on Day 1|"FEV1 AUC(0-3h) was calculated as the area under the FEV1- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres.
FEV1 AUC(0-3h) response was defined as FEV1 AUC(0-3h) minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.
The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on the first day of randomized treatment|FAS. Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Least Squares Mean
692249|NCT01431287|Secondary|Mahler Transitional Dyspnoea Index (TDI) Focal Score on Day 169 From the Two Twin Trials, Present 1237.6 (NCT01431287) and 1237.5 (NCT01431274)|"Mahler Transitional Dyspnoea Index (TDI) focal score on Day 169 From the Two Twin Trials, Present 1237.6 (NCT01431287) and 1237.5 (NCT01431274) is the key secondary endpoint.
The Mahler Dyspnoea questionnaire is an instrument which measures change from the baseline state The TDI focal score was used to measure the effect of Tio+Olo FDC on patients' dyspnoea after 24 weeks of treatment (Day 169). The focal score is the sum of the subscale scores for Functional Impairment, Magnitude of Effort and Magnitude of Task. Scores for each subscale range from -3 to 3 so that the Focal score ranges from -9 to 9. For all subscale scores and the Focal score a higher value indicates a better outcome.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group."|Day 169|FAS. Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||points on a scale||Standard Error|Least Squares Mean
692250|NCT01431287|Primary|Saint George’s Respiratory Questionnaire (SGRQ) Total Score on Day 169 From the Two Twin Trials, Present 1237.6 (NCT01431287) and 1237.5 (NCT01431274).|"The SGRQ is designed to measure health impairment in patients with COPD. It is divided into 2 parts: part 1 produces the symptoms score, and part 2 the activity and impacts scores. A total score is also produced. Each subscale score is the sum of the weights for the items in the subscale as a percent of the sum of the weights for a patient in the worst possible condition. The total score uses the same calculation except that the weights are summed over the entire questionnaire. The individual subscales as well as the total score can range from 0 to 100 with a lower score denoting a better health status.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group."|Day 169|FAS. Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||points on a scale||Standard Error|Least Squares Mean
692251|NCT01431287|Primary|Trough FEV1 Response on Day 170|"Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours) and was calculated as the mean of the 2 FEV1 measurements performed at 23 h and at 23 h 50 min after inhalation of study medication at the clinic visit on the previous day.
Trough FEV1 response was defined as trough FEV1 minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).
The adjusted means (SE) were obtained from fitting an MMRM including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 23 h and at 23 h 50 min after inhalation of study medication on Day 170|FAS. Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Least Squares Mean
692252|NCT01431287|Primary|Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) (0-3h) Response on Day 169|"FEV1 AUC(0-3h) was calculated as the area under the FEV1- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres. FEV1 AUC(0-3h) response was defined as FEV1 AUC(0-3h) minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).
The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom. Number of participants analyzed are the number of patients contributing to the MMRM model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 169|The Full analysis set (FAS) included all patients who were randomised, who were dispensed study medication, were documented to have taken any dose of study medication and who had a non-missing baseline and at least one non-missing post-baseline measurement before or at Week 24 for any of the primary and key secondary efficacy endpoints.||Litres||Standard Error|Least Squares Mean
692302|NCT01430819|Other Pre-specified|Number of Participants With Seroconversion Following Vaccination With Either Fluzone® or Fluzone® High-Dose Vaccine|"Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay.
Seroconversion was defined as either a pre-vaccination HAI titer < 1:10 and a post-vaccination titer ≥ 1:40; or a pre-vaccination titer ≥ 1:10 and a four-fold increase in post-vaccination titer."|Day 21 post-vaccination|Seroconversion to Influenza vaccine antigens were determined in all enrolled and vaccinated participants, per-protocol population||Participants|||Number
692645|NCT01425853|Secondary|Number of Participants With at Least One Adverse Events|The safety evaluation was done in the set of randomized patients who took at least one dose of the medication|6 months|Safety population||number of participants|||Number
692253|NCT01431274|Secondary|Mahler Transitional Dyspnoea Index (TDI) Focal Score on Day 365 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287)|"Mahler Transitional Dyspnoea Index (TDI) focal score on Day 365 From the Two Twin Trials, present 1237.5 (NCT01431274) and 1237.6 (NCT01431287).
The Mahler Dyspnoea questionnaire is an instrument which measures change from the baseline state The TDI focal score was used to measure the effect of Tio+Olo FDC on patients' dyspnoea after 24 weeks of treatment (Day 169). The focal score is the sum of the subscale scores for Functional Impairment, Magnitude of Effort and Magnitude of Task. Scores for each subscale range from -3 to 3 so that the Focal score ranges from -9 to 9. For all subscale scores and the Focal score a higher value indicates a better outcome. Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group."|Day 365|FAS (day 365). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||points on a scale||Standard Error|Least Squares Mean
692254|NCT01431274|Secondary|Mahler Transitional Dyspnoea Index (TDI) Focal Score on Day 85 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287)|"Mahler Transitional Dyspnoea Index (TDI) focal score on Day 85 From the Two Twin Trials, present 1237.5 (NCT01431274) and 1237.6 (NCT01431287).
The Mahler Dyspnoea questionnaire is an instrument which measures change from the baseline state The TDI focal score was used to measure the effect of Tio+Olo FDC on patients' dyspnoea after 24 weeks of treatment (Day 169). The focal score is the sum of the subscale scores for Functional Impairment, Magnitude of Effort and Magnitude of Task. Scores for each subscale range from -3 to 3 so that the Focal score ranges from -9 to 9. For all subscale scores and the Focal score a higher value indicates a better outcome.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group."|Day 85|FAS||points on a scale||Standard Error|Least Squares Mean
692255|NCT01431274|Secondary|Mahler Transitional Dyspnoea Index (TDI) Focal Score on Day 43 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287)|"Mahler Transitional Dyspnoea Index (TDI) focal score on Day 43 From the Two Twin Trials, present 1237.5 (NCT01431274) and 1237.6 (NCT01431287).
The Mahler Dyspnoea questionnaire is an instrument which measures change from the baseline state The TDI focal score was used to measure the effect of Tio+Olo FDC on patients' dyspnoea after 24 weeks of treatment (Day 169). The focal score is the sum of the subscale scores for Functional Impairment, Magnitude of Effort and Magnitude of Task. Scores for each subscale range from -3 to 3 so that the Focal score ranges from -9 to 9. For all subscale scores and the Focal score a higher value indicates a better outcome. Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group."|Day 43|FAS (day 43). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||points on a scale||Standard Error|Least Squares Mean
692256|NCT01431274|Secondary|Saint George’s Respiratory Questionnaire (SGRQ) Total Score on Day 365 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287)|The SGRQ is designed to measure health impairment in patients with COPD. It is divided into 2 parts: part 1 produces the symptoms score, and part 2 the activity and impacts scores. A total score is also produced. Each subscale score is the sum of the weights for the items in the subscale as a percent of the sum of the weights for a patient in the worst possible condition. The total score uses the same calculation except that the weights are summed over the entire questionnaire. The individual subscales as well as the total score can range from 0 to 100 with a lower score denoting a better health status. Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group.|Day 365|FAS (day 365). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||points on a scale||Standard Error|Least Squares Mean
692257|NCT01431274|Secondary|Saint George’s Respiratory Questionnaire (SGRQ) Total Score on Day 85 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287)|The SGRQ is designed to measure health impairment in patients with COPD. It is divided into 2 parts: part 1 produces the symptoms score, and part 2 the activity and impacts scores. A total score is also produced. Each subscale score is the sum of the weights for the items in the subscale as a percent of the sum of the weights for a patient in the worst possible condition. The total score uses the same calculation except that the weights are summed over the entire questionnaire. The individual subscales as well as the total score can range from 0 to 100 with a lower score denoting a better health status. Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group.|Day 85|FAS (day 85). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||points on a scale||Standard Error|Least Squares Mean
692258|NCT01431274|Secondary|FVC AUC(0-24h) Response in Sub-set of Patients With 24-h PFTs on Day 169 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287)|"FVC AUC(0-24h) was calculated as the area under the FVC- time curve from 0 to 24 h post-dose using the trapezoidal rule, divided by the duration (24 h) to report in litres.
FVC AUC(0-24h) response was defined as FVC AUC(0-24h) minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).
The adjusted mean (SE) were obtained from fitting an ANCOVA model with categorical effect of treatment and baseline as covariate.
Number of participants analyzed are the number of patients contributing to the ANCOVA model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h, 23 h, 23 h and 50 min post-dose on Day 169.|12−hr PFT set||Litres||Standard Error|Least Squares Mean
692303|NCT01430819|Other Pre-specified|Geometric Mean Titers of Antibodies to Vaccine Antigens Before and Following Vaccination With Either Fluzone® or Fluzone® High-Dose Vaccine.|Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay.|Day 21 post-vaccination|GMTs of antibodies against Influenza vaccine antigens were determined in all enrolled and vaccinated participants, per-protocol population||Titers||95% Confidence Interval|Geometric Mean
703383|NCT00094900|Secondary|Mean Change in C-Reactive Protein||24 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||mg/dl||Standard Error|Mean
692259|NCT01431274|Secondary|FVC AUC(0-12h) Response in the Sub-set of Patients With 12-h PFTs on Day 169 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287)|"FVC AUC(0-12h) was calculated as the area under the FVC- time curve from 0 to 12 h post-dose using the trapezoidal rule, divided by the duration (12 h) to report in litres.
FVC AUC(0-12h) response was defined as FVC AUC(0-12h) minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).
The adjusted mean (SE) were obtained from fitting an ANCOVA model with categorical effect of treatment and baseline as covariate. Number of participants analyzed are the number of patients contributing to the ANCOVA model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h post-dose on Day 169.|12−hr PFT set||Litres||Standard Error|Least Squares Mean
692260|NCT01431274|Secondary|FEV1 AUC(0-24h) Response in the Sub-set of Patients With 12-h PFTs on Day 169 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287)|"FEV1 AUC(0-24h) was calculated as the area under the FEV1- time curve from 0 to 24 h post-dose using the trapezoidal rule, divided by the duration (24 h) to report in litres. FEV1 AUC(0-24h) response was defined as FEV1 AUC(0-24h) minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).
The adjusted mean (SE) were obtained from fitting an ANCOVA model with categorical effect of treatment and baseline as covariate.
Number of participants analyzed are the number of patients contributing to the ANCOVA model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h, 23 h, 23 h and 50 min post-dose on Day 169.|12−hr PFT set||Litres||Standard Error|Least Squares Mean
692261|NCT01431274|Secondary|FEV1 AUC(0-12h) Response in the Sub-set of Patients With 12-hour Pulmonary Function Test (PFT) on Day 169 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287)|"FEV1 AUC(0-12h) was calculated as the area under the FEV1- time curve from 0 to 12 h post-dose using the trapezoidal rule, divided by the duration (12 h) to report in litres.
FEV1 AUC(0-12h) response was defined as FEV1 AUC(0-12h) minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).
The adjusted mean (SE) were obtained from fitting an ANCOVA model with categorical effect of treatment and baseline as covariate.
Number of participants analyzed are the number of patients contributing to the ANCOVA model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h post-dose on Day 169.|12 hr PFT set: All patients who have given Informed Consent for the 12-hour PFT testing and had any spirometry measurement after 3-hour and before or at 12-hours post-dose on Days 169 and 170.||Litres||Standard Error|Least Squares Mean
692262|NCT01431274|Secondary|Trough FVC Response on Day 365.|"Trough FVC was defined as the FVC value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.
Trough FVC response was defined as trough FVC minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group.
The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and on Day 365.|FAS (day 365). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Least Squares Mean
692263|NCT01431274|Secondary|Trough FVC Response on Day 170.|"Trough FVC was defined as the FVC value at the end of the dosing interval (24 hours) and was calculated as the mean of the 2 FVC measurements performed at 23h and at 23h 50 min after inhalation of study medication at the clinic visit on the previous day.
Trough FVC response was defined as trough FVC minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).
The adjusted means (SE) were obtained from fitting an MMRM including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 23 h and at 23 h 50 min after inhalation of study medication on Day 170|FAS. Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Least Squares Mean
692264|NCT01431274|Secondary|Trough FVC Response on Day 85.|"Trough FVC was defined as the FVC value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.
Trough FVC response was defined as trough FVC minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group.
The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and on day 85|FAS (day 85). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Least Squares Mean
692712|NCT01425307|Secondary|Effects on Quality of Life|Standard Quality of Life measure will be taken during specific time points as well as one newly developed Sickle Cell Disease-specific test.|24 months||||||
692265|NCT01431274|Secondary|Trough FVC Response on Day 43.|"Trough FVC was defined as the FVC value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.
Trough FVC response was defined as trough FVC minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group.
The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 10 min pre-dose on day 43|FAS (day 43). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Least Squares Mean
692266|NCT01431274|Secondary|Trough FVC Response on Day 15.|"Trough FVC was defined as the FVC value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.
Trough FVC response was defined as trough FVC minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group.
The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 10 min pre-dose on day 15|FAS (day 15). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Least Squares Mean
692267|NCT01431274|Secondary|FVC (Forced Vital Capacity) AUC(0-3h) Response on Day 365|"FVC AUC(0-3h) was calculated as the area under the FVC- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres.
FVC AUC(0-3h) response was defined as FVC AUC(0-3h) minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).
The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 365 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 365.|FAS (day 365). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Least Squares Mean
692268|NCT01431274|Secondary|FVC (Forced Vital Capacity) AUC(0-3h) Response on Day 169|"FVC AUC(0-3h) was calculated as the area under the FVC- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres.
FVC AUC(0-3h) response was defined as FVC AUC(0-3h) minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).
The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 169.|FAS (day 169). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Least Squares Mean
692269|NCT01431274|Secondary|FVC (Forced Vital Capacity) AUC(0-3h) Response on Day 85|"FVC AUC(0-3h) was calculated as the area under the FVC- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres.
FVC AUC(0-3h) response was defined as FVC AUC(0-3h) minus baseline FVC.Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).
The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 85 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 85.|FAS (day 85). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Least Squares Mean
692304|NCT01430819|Primary|Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Fluzone® or Fluzone® High-Dose Vaccine|"Solicited injection site reactions: Pain, Erythema and Swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.
Grade 3 solicited reactions were defined as: Fever ≥ 39.0°C; Pain, Headache, Malaise and Myalgia, significant, prevents daily activities; Erythema and Swelling > 100 mm."|Day 0 to up to Day 28 post-vaccination|Solicited injection site and systemic reactions were assessed in all enrolled and vaccinated participants, Intent-to-treat population (Safety Analysis Set).||Participants|||Number
692270|NCT01431274|Secondary|FVC (Forced Vital Capacity) AUC(0-3h) Response on Day 1|"FVC AUC(0-3h) was calculated as the area under the FVC- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres.
FVC AUC(0-3h) response was defined as FVC AUC(0-3h) minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).
The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on the first day of randomized treatment.|FAS (day 1). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Least Squares Mean
692271|NCT01431274|Secondary|Trough FEV1 Response on Day 365|"Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.
Trough FEV1 response was defined as trough FEV1 minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed
1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 1 hr and 10 min pre-dose on day 365|FAS (day 365). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Least Squares Mean
692272|NCT01431274|Secondary|Trough FEV1 Response on Day 169|"Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.
Trough FEV1 response was defined as trough FEV1 minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed
1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 1 hr and 10 min pre-dose on Day 169|FAS (day 169). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Least Squares Mean
692273|NCT01431274|Secondary|Trough FEV1 Response on Day 85|"Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.
Trough FEV1 response was defined as trough FEV1 minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed
1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 1 hr and 10 min pre-dose on day 85.|FAS (day 85). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Least Squares Mean
692274|NCT01431274|Secondary|Trough FEV1 Response on Day 43|"Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.
Trough FEV1 response was defined as trough FEV1 minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed
1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 10 min pre-dose on day 43.|FAS (day 43). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Least Squares Mean
692275|NCT01431274|Secondary|Trough FEV1 Response on Day 15.|"Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.
Trough FEV1 response was defined as trough FEV1 minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed
1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 10 min pre-dose on day 15|FAS (day 15). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Least Squares Mean
692276|NCT01431274|Secondary|FEV1 AUC(0-3h) Response on Day 365|"FEV1 AUC(0-3h) was calculated as the area under the FEV1- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres. FEV1 AUC(0-3h) response was defined as FEV1 AUC(0-3h) minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.
The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 365 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 365.|FAS (on day 365). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Least Squares Mean
692277|NCT01431274|Secondary|FEV1 AUC(0-3h) Response on Day 85|"FEV1 AUC(0-3h) was calculated as the area under the FEV1- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres. FEV1 AUC(0-3h) response was defined as FEV1 AUC(0-3h) minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.
The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 85 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 85.|FAS. Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Least Squares Mean
692278|NCT01431274|Secondary|FEV1 AUC(0-3h) Response on Day 1|"FEV1 AUC(0-3h) was calculated as the area under the FEV1- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres.
FEV1 AUC(0-3h) response was defined as FEV1 AUC(0-3h) minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.
The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on the first day of randomized treatment.|FAS. Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Least Squares Mean
692279|NCT01431274|Secondary|Mahler Transitional Dyspnoea Index (TDI) Focal Score on Day 169 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287)|"Mahler Transitional Dyspnoea Index (TDI) focal score on Day 169 From the Two Twin Trials, present 1237.5 (NCT01431274) and 1237.6 (NCT01431287) is the key secondary endpoint.
The Mahler Dyspnoea questionnaire is an instrument which measures change from the baseline state The TDI focal score was used to measure the effect of Tio+Olo FDC on patients' dyspnoea after 24 weeks of treatment (Day 169). The focal score is the sum of the subscale scores for Functional Impairment, Magnitude of Effort and Magnitude of Task. Scores for each subscale range from -3 to 3 so that the Focal score ranges from -9 to 9. For all subscale scores and the Focal score a higher value indicates a better outcome. Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group."|Day 169|FAS. Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||points on a scale||Standard Error|Least Squares Mean
692280|NCT01431274|Primary|Saint George’s Respiratory Questionnaire (SGRQ) Total Score on Day 169 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287)|The SGRQ is designed to measure health impairment in patients with COPD. It is divided into 2 parts: part 1 produces the symptoms score, and part 2 the activity and impacts scores. A total score is also produced. Each subscale score is the sum of the weights for the items in the subscale as a percent of the sum of the weights for a patient in the worst possible condition. The total score uses the same calculation except that the weights are summed over the entire questionnaire. The individual subscales as well as the total score can range from 0 to 100 with a lower score denoting a better health status. Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group.|Day 169|FAS. Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||points on a scale||Standard Error|Least Squares Mean
692281|NCT01431274|Primary|Trough FEV1 Response on Day 170.|"Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours) and was calculated as the mean of the 2 FEV1 measurements performed at 23 h and at 23 h 50 min after inhalation of study medication at the clinic visit on the previous day.
Trough FEV1 response was defined as trough FEV1 minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).
The adjusted means (SE) were obtained from fitting an MMRM including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 23 h and at 23 h 50 min after inhalation of study medication on Day 170|FAS. Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Least Squares Mean
692305|NCT01430754|Secondary|Change From Run-In in Circadian Time to Relapse During the Randomized Phase|Time to relapse is defined as a 45 minute or greater decrement in the weekly average of subjective nighttime total sleep time (nTST) compared to the Run-in Phase.|Approximately 8 weeks|||days||95% Confidence Interval|Median
692306|NCT01430754|Secondary|Change From Run-In in Midpoint of Sleep (MoST) During the Randomized Phase|Midpoint of Sleep Timing (MoST) is the measurement of the average timing of sleep relative to bedtime. The average MoST value will trend to 0 as an individual’s sleep becomes more fragmented. Improvement is defined as an increase in the average.|Approximately 12 weeks|||minutes||Standard Error|Mean
692713|NCT01425307|Secondary|Change of Baseline in Hepatic Iron Overload as Assessed by Serum Ferritin|This secondary objective will compare standard to alternative therapy for hepatic iron overload.|Baseline and 24 months|||ng per mL||Standard Deviation|Mean
692282|NCT01431274|Primary|Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) (0-3h) Response on Day 169.|"FEV1 AUC(0-3h) was calculated as the area under the FEV1- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres. FEV1 AUC(0-3h) response was defined as FEV1 AUC(0-3h) minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).
The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom. Number of participants analyzed are the number of patients contributing to the MMRM model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 169.|The Full analysis set (FAS) included all patients who were randomised, who were dispensed study medication, were documented to have taken any dose of study medication and who had a non-missing baseline and at least one non-missing post-baseline measurement before or at Week 24 for any of the primary and key secondary efficacy endpoints.||Litres||Standard Error|Least Squares Mean
692283|NCT01431170|Post-Hoc|Number of Subjects Treated Successfully at Close-Out Visit (Week 16)|Treatment Success is defined as a grade of 0 or improvement by 2 or more compared to the prior visit.|Baseline to Week 16 (Close-Out Visit)|||Number of Treatment Success|||Number
692284|NCT01431170|Secondary|Medication Safety Outcomes|During each study visit, the Principal Investigator will evaluate any possible adverse events by assessing clinical complaints and symptoms that are experienced by subjects and observed by the parent(s)/legal guardian(s), including findings in external, lacrimal duct system and anterior segment using slit lamp and fundus exam using indirect ophthalmoscope by principal investigator, as well as clinical signs including findings in external, nasolacrimal duct system and anterior segment using slit lamp and fundus exam using indirect ophthalmoscope by principal investigator.|Baseline to Week 16 (Closeout Visit )|No safety issues were reported||Number of Adverse Events|||Number
692285|NCT01431170|Secondary|Treatment Failure|"Possible treatment failure at a follow-up examination is operationally defined as follows: if the physician-grading scale of NLDO is worse than or same as the prior visit at any given follow-up visit, possible treatment failure then exists.
Treatment Failure occurred if at visit #1 (2-week visit), the physician-grading scale of NLDO is worse than or same as the baseline visit. Treatment failure can also occur at recurrence visit #1 if the NLDO grading scale is worse or the same as compared to the previous visit. Subjects who meet the criteria for treatment failure were withdrawn from the study by the principal investigator and no additional data was collected. Subjects were referred for continued care."|Baseline to the time of failure or Week 16 (Closeout Visit)|||Number of Treatment Failures|||Number
692286|NCT01431170|Secondary|Efficacy of Recurrence Treatment as Measured by Change in the Physician- Rated Scale of NLDO|"Subjects who experience recurrence were re-treated as if they were a new patient, with the same study medication, were followed up then classified as Treatment Success or Treatment Failure according to study protocol."|Baseline to Week 16 (Closeout Visit)|||participants|||Number
692287|NCT01431170|Secondary|Number of Recurrences by Randomization Group|"Recurrence is defined as when the NLDO with infection in the subject’s study eye returns, as indicated by a NLDO grading scale of greater than zero after achieving a grade of zero at the previous visit.
Number of subjects who had a recurrence event of the subjects who completed the study by treatment Group."|Baseline to Week 16 (Closeout Visit )|The overall study recurrence rate was 10% study-wide (2 of 20 subjects), with one Besivance subject (11%), and one Polytrim subject (9%) experiencing recurrence.||Recurrence Subjects|||Number
692288|NCT01431170|Primary|Change in Physician-rated Scale of NLDO From Baseline to Follow-Up Visit at Week 8 or From Baseline to Time of Treatment Failure, if Earlier.|"The NLDO grading scale in the study eye at every visit. The scale ranges from 0 to +4:
0: No tearing and discharge.
1: Tearing, moderate mucous discharge around nasolacrimal punctum
2: Moderate redness of the medial eyelid with mucous discharge
3: Redness and swelling of the eyelid with mucopurulent discharge
4: Redness and swelling of eyelid with purulent discharge
Due to varying baseline severity (measured by NLDO grade) among subjects, change from baseline to week 8 in NLDO grade was further classified as the following:
Treatment success: grade of 0 or improvement by 2 or more compared to the prior visit.
Recurrence: NLDO with infection returns in the study eye, as indicated by a NLDO grade >0 after a grade of 0 at the prior visit.
Treatment Failure: grade is worse than or same as the baseline visit."|Baseline to Week 8|||participants|||Number
692289|NCT01431144|Primary|Soft Tissue Thickness Over the Implant|Soft tissue thickness at the facial osseous crest.|1 year|||mm||Standard Deviation|Mean
692290|NCT01431131|Secondary|Histologic Healing of the Osseous Graft|Histologic analysis to determine vital bone, nonvital bone, and trabecular space percentages|4 months|||percentage vital bone||Standard Deviation|Mean
692291|NCT01431131|Primary|Horizontal Ridge Dimension|WIll be measured with a digital caliper at baseline and 4 months.|Baseline and 4 months|||mm||Standard Deviation|Mean
692292|NCT01431079|Secondary|Change From Baseline and After the Interventions to up to 3 Months Follow-up in Score of Self-efficacy for Receiving HPV Vaccine|"Before the interventions and after the interventions the health belief model construct of self-efficacy for receiving HPV vaccine scores will be measured on a paper pencil self-report test and changes noted. Self-efficacy for receiving HPV vaccine will be measured as a summative score on a three item Likert subscale with a range of 0 to 12 (0- not likely to 12- very likely). The subscale has acceptable validity and reliability.
The difference between post and pre-test was taken to determine a change score. This score was then used for regressions."|Post interventions and up to 3 months follow-up|A sample size of 90 men total (Erdfleder, Faul, & Buchner, 1996) was needed for the intervention. This was calculated by G*Power based on: alpha= 0.05, power=.80, groups=2, measurements=2, effect size=.20, correlations among repeated measures-0.5, nonsphericity correction ε=1, giving us total sample of 90.||units on a scale||Standard Deviation|Mean
692307|NCT01430754|Secondary|Change From Run-In in Total Daytime Sleep Duration in Lower Quartile of Days (UQ-dTSD) During the Randomized Phase|UQ-dTSD measures the average daytime sleep during the patient's worst 25% of days (longest total daytime sleep) from run-in and randomized phase. Lower number indicates improvement.|Approximately 12 weeks|||minutes||Standard Error|Mean
738607|NCT00450749|Secondary|Growth Potential Assessed by the Ratio of Proliferation (Ki-67):Apoptosis (TUNEL) in Prostatic Surgical Tissue||At 4-7 weeks||||||
692293|NCT01431079|Secondary|Change From Baseline to After the Interventions to Follow-up up to 3 Months After the Interventions in Score of Cues to Action to Receiving HPV Vaccine|"Before the interventions, and after the interventions and up to 3 months after the interventions the health belief model construct of cues to action to receiving HPV vaccine scores will be measured on a paper pencil self-report test and changes noted. Cues to action to receiving HPV vaccine will be measured as a summative score on a four item Likert subscale with a range of 0 to 16 (0- not at all likely to 16-very likely). The subscale has acceptable validity and reliability.
Difference between post and pre-test were used to obtain a change score. This score was used for regressions."|Post interventions and up to three months after the intervention|A sample size of 90 men total (Erdfleder, Faul, & Buchner, 1996) was needed for the intervention. This was calculated by G*Power based on: alpha= 0.05, power=.80, groups=2, measurements=2, effect size=.20, correlations among repeated measures-0.5, nonsphericity correction ε=1, giving us total sample of 90.||units on a scale||Standard Deviation|Mean
692294|NCT01431079|Secondary|Change From Baseline to Post Test After the Interventions to Follow-up (up to 3 Months) in the Score of Perceived Barriers to Receiving HPV Vaccine|"Before the interventions, post test after the interventions following the interventions the health belief model construct of perceived barriers to receiving HPV vaccine scores will be measured on a paper pencil self-report test and changes noted. Perceived barriers for receiving HPV vaccine will be measured as a summative score on a three item Likert subscale with a range of 0 to 12 (0- not likely to 12- very likely). The subscale has acceptable validity and reliability.
A difference between post-test and pre-test were taken to obtain the score. This score was then used in the regression."|post interventions and up to 3 months after the intervention|A sample size of 90 men total (Erdfleder, Faul, & Buchner, 1996) was needed for the intervention. This was calculated by G*Power based on: alpha= 0.05, power=.80, groups=2, measurements=2, effect size=.20, correlations among repeated measures-0.5, nonsphericity correction ε=1, giving us total sample of 90.||units on a scale||Standard Deviation|Mean
692295|NCT01431079|Secondary|Change From Baseline to Post Test After the Interventions to up to 3 Month Follow-up in Score of Perceived Benefits of HPV Vaccine|"Before the interventions, after the interventions and one month following the interventions the health belief model construct of Perceived benefits of HPV vaccine scores will be measured on a paper pencil self-report test and changes noted. Perceived benefits of HPV vaccine will be measured as a summative score on a four item Likert subscale with a range of 0 to 16 (0-not very likely and 16- very likely). The subscale has acceptable validity and reliability.
Difference between posttest and pre-test was done. This value was then used to run the multiple regressions."|post intervention and up to 3 months after the interventions|A sample size of 90 men total (Erdfleder, Faul, & Buchner, 1996) was needed for the intervention. This was calculated by G*Power based on: alpha= 0.05, power=.80, groups=2, measurements=2, effect size=.20, correlations among repeated measures-0.5, nonsphericity correction ε=1, giving us total sample of 90.||units on a scale||Standard Deviation|Mean
692296|NCT01431079|Secondary|Change From Baseline to Post Test to Upto 3 Month Follow-up After the Interventions in Score for Perceived Severity for HPV|"Before the interventions, after the interventions and up to 3 months following the interventions the health belief model construct of perceived severity for HPV scores will be measured on a paper pencil self-report test and changes noted. Perceived severity for HPV will be measured as a summative score on a three item Likert subscale with a range of 0 to 12 to 12 (0- not likely and 12-very likely). The subscale has acceptable validity and reliability.
Difference between posttest and pre-test was done. This value was then used to run the multiple regressions."|Post interventions and up to 3 months after the intervention|A sample size of 90 men total (Erdfleder, Faul, & Buchner, 1996) was needed for the intervention. This was calculated by G*Power based on: alpha= 0.05, power=.80, groups=2, measurements=2, effect size=.20, correlations among repeated measures-0.5, nonsphericity correction ε=1, giving us total sample of 90.||units on a scale||Standard Deviation|Mean
692297|NCT01431079|Secondary|Change From Baseline to Post Intervention to Follow-up (up to 3 Months) After the Interventions in Score of Perceived Susceptibility for HPV|"Before the interventions, after the interventions and up to 3 months following the interventions the health belief model construct of perceived susceptibility for HPV scores will be measured on a paper pencil self-report test and changes noted. Perceived susceptibility for HPV will be measured as a summative score on a three item Likert subscale with a range of 0 to 12 (0- not likely and 12-very likely). The subscale has acceptable validity and reliability.
Difference between posttest and pre-test was done. This value was then used to run the multiple regressions."|Post interventions and up to 3 months after the interventions|A sample size of 90 men total (Erdfleder, Faul, & Buchner, 1996) was needed for the intervention. This was calculated by G*Power based on: alpha= 0.05, power=.80, groups=2, measurements=2, effect size=.20, correlations among repeated measures-0.5, nonsphericity correction ε=1, giving us total sample of 90.||units on a scale||Standard Deviation|Mean
692298|NCT01431079|Primary|Change From Baseline to Post Intervention to Follow-up up to 3 Months After the Interventions the Number of Participants Who Intend to Take HPV Vaccine Using HPV Intent Scale (Possible Range 0-4 Likert Units)|"Before the interventions, post test after the interventions and follow-up 1 to 3 months after the interventions (health belief model based and knowledge based) participants will be asked about their intent to take the HPV vaccine on a scale of 0-4 Likert units and changes noted.
Posttest was conducted immediately after the intervention. Minimum score = 0 indicating no intent to take vaccine; Maximum score = 4 indicating strong intent to take vaccine. Scale was a single item scale."|Post intervention and up to 3 months after the intervention|A sample size of 90 men total (Erdfleder, Faul, & Buchner, 1996) was needed for the intervention. This was calculated by G*Power based on: alpha= 0.05, power=.80, groups=2, measurements=2, effect size=.20, correlations among repeated measures-0.5, nonsphericity correction ε=1, giving us total sample of 90.||units on a scale||Standard Deviation|Mean
692299|NCT01431079|Primary|Change From Baseline to Post Intervention to Follow-up (up to 3 Months) After the Interventions the Number of Participants Who Have Taken the HPV Vaccine|Before, after and one to three month following the health belief model based educational intervention and knowledge-based educational intervention the participants will be asked if they have taken the first dose of HPV vaccine and changes noted.|Post intervention and up to 3 months after the interventions|A sample size of 90 men total (Erdfleder, Faul, & Buchner, 1996) was needed for the intervention. This was calculated by G*Power based on: alpha= 0.05, power=.80, groups=2, measurements=2, effect size=.20, correlations among repeated measures-0.5, nonsphericity correction ε=1, giving us total sample of 90.||participants|||Number
692309|NCT01430754|Secondary|Maintenance of Entrainment (Cortisol) in Subjects With N24HSWD|Entrainment is a measure of synchronization of the master body clock to the 24-hour day. The circadian period (τ) was calculated using urinary cortisol collected over four separate 48 hour periods, approximately 1 week apart, during the run-in and randomized phases of the trial. Maintenance of entrainment is defined as the proportion of subjects who become non-entrained to a 24 hour day after randomization to tasimelteon or placebo. Non-entrainment was defined as having a post-baseline τ value ≥ 24.1 or the lower bound of the 95% CI >24.0.|Approximately 12 weeks|||participants|||Number
692310|NCT01430754|Primary|Maintenance of Entrainment (aMT6s) in Subjects With N24HSWD.|Entrainment is a measure of synchronization of the master body clock to the 24-hour day. The circadian period (τ) was calculated using urinary aMT6s collected over four separate 48 hour periods, approximately 1 week apart, during the run-in and randomized phases of the trial. Maintenance of entrainment is defined as the proportion of subjects who become non-entrained to a 24 hour day after randomization to tasimelteon or placebo. Non-entrainment was defined as having a post-baseline τ value ≥ 24.1 or the lower bound of the 95% CI >24.0.|Approximately 12 weeks|||participants|||Number
692311|NCT01430741|Post-Hoc|Estimated Proportion of Veterans Without Negative Housing Exits|We obtained information on negative housing exits from the HUD-VASH Exit form, which is available in HOMES and tracks the dates and reasons for all exits from the program. We measured whether and when a Veteran experienced a negative housing over the period from study enrollment (i.e. the first date of MISSION-Vet for those served by case managers in the GTO group and the date of the first MISSION-Vet session provided to any Veteran at the appropriate study site for this in the comparison group) until the end of the study observation period; the maximum follow-up time was 2.4 years, but only for HUD-VASH Exits. A negative exit was defined as an exit from HUD-VASH that occurred due to non-compliance with case management, eviction, Veteran dissatisfaction with housing, inability to locate Veteran and incarceration. Kaplan-Meier survival curves to calculate an estimate of the proportion of Veterans in each arm/group not experiencing a negative exit from housing at the study’s endpoint.|12 months|All MISSION-Vet IU Veterans and GTO Veterans were analyzed from HUD-VASH data monitoring system HOMES (Homeless Operations, Management and Evaluation).||Proportion of Veterans||95% Confidence Interval|Number
692312|NCT01430741|Post-Hoc|Predicted Values of Veteran Emergency Department Visits for Medical and Mental Health Concerns|Number of emergency department visits for medical and for mental health. Assessed on a monthly basis for 12 months following study enrollment. These measures were obtained from the standardized monthly and quarterly status reports completed by case managers, which were extracted from HOMES. A dichotomous measure of whether a veteran experienced an emergency department visit for medical or mental health conditions , and not a count of number of emergency department visits. We used a mixed-effects logistic regression model to calculate a predicted values (i.e. a Least-Squares Mean) for each group/arm at the study’s end-point holding all variables in the model (Veteran age, Veteran sex, presence of an SMI diagnosis, employment) constant at their mean value. Predicted value reported in log-odds (logit) units.|12 months|All MISSION-Vet IU Veterans and GTO Veterans were analyzed from HUD-VASH data monitoring system HOMES (Homeless Operations, Management and Evaluation).||Log Odd Units of Emergency Dept. Visits||Standard Error|Least Squares Mean
692313|NCT01430741|Post-Hoc|Predicted Values of Veteran Inpatient Hospitalizations for Medical and Mental Health Conditions|Number of inpatient hospitalization for medical and mental health conditions. Assessed on a monthly basis for 12 months following study enrollment. These measures were obtained from the standardized monthly and quarterly status reports completed by case managers, which were extracted from HOMES. A dichotomous measure of whether a veteran experienced an inpatient hospitalization for medical or mental health conditions , and not a count of number of hospitalizations. Specifically, we used a mixed-effects logistic regression model to calculate a predicted values (i.e. a Least-Squares Mean) for each group/arm at the study’s end-point holding all variables in the model (Veteran age, Veteran sex, presence of an SMI diagnosis, employment) constant at their mean value. Predicted value reported in log-odds (logit) units.|12 months|All MISSION-Vet IU Veterans and GTO Veterans were analyzed from HUD-VASH data monitoring system HOMES (Homeless Operations, Management and Evaluation).||Inpatient Hospitalization Log Odds Units||Standard Error|Least Squares Mean
692314|NCT01430741|Post-Hoc|Drug and Alcohol Dependence|Examined monthly alcohol and drug use by Veterans. Assessed on a monthly basis for 12 months following study enrollment. These measures were obtained from the standardized monthly and quarterly status reports completed by case managers, which were extracted from HOMES.|12 months|All MISSION-Vet IU Veterans and GTO Veterans were analyzed from HUD-VASH data monitoring system HOMES (Homeless Operations, Management and Evaluation).||Monthly Substance Use||Standard Error|Least Squares Mean
692315|NCT01430741|Post-Hoc|Number of Services Provided by Case Managers and Peers to Veterans|Services provided by Case Managers OR Peers was computed by a count of the number of contacts between case managers OR peers and Veterans. This computed a total of all Veteran contacts, which was the sum of face-to-face contacts with Veterans and contacts on behalf of Veterans (described as Veteran contacts) with other stakeholders (e.g. family, medical providers). Assessed on a monthly basis for 12 months following study enrollment. These measures were obtained from the standardized monthly and quarterly status reports completed by case managers, which were extracted from HOMES. We used a linear-mixed effects model to calculate a Least-Squares Mean for each group at the study’s end-point holding all variables in the model (Veteran age, Veteran sex, presence of an SMI diagnosis, employment) constant at their mean value.|12 months|All MISSION-Vet IU Veterans and GTO Veterans were analyzed from HUD-VASH data monitoring system HOMES (Homeless Operations, Management and Evaluation).||Number of Service Contacts||Standard Error|Least Squares Mean
692316|NCT01430741|Primary|MISSION Fidelity Index|The fidelity index assesses the presence or absences of activities within MISSION-Vet – DRT, peer led sessions, self-guided exercises, referrals made, and/or delivery of the workbook, to each participating Veteran. We analyzed fidelity as the percent of adoption of MISSION-Vet. The threshold for fidelity to adopt MISSION-Vet is 1 contact between the case manager and each participating Veteran. There is no composite score, fidelity to MISSION-Vet is if the case manager conducted at least 1 session with a Veteran.This measure was embedded into the VA Electronic Medical Record System. The investigators will assess the impact GTO has in facilitating adoption and use with fidelity to the MISSION-Vet 12-month service delivery platform, in comparison to implementation as usual.|12-months|Clinician fidelity to MISSION-Vet using IU or GTO. Only assessed Staff population.||percentage of MISSION-Vet staff use|||Number
692323|NCT01430624|Primary|Alcohol Use Disorders Identification Test (AUDIT)|Total scores range from 0 - 40 with higher scores indicating greater problem severity, post assault at 6 months|6 months|Includes only participants with full scale score information at 6 months||units on a scale||Standard Deviation|Mean
692324|NCT01430624|Primary|Drug Abuse Screening Test (DAST-10)|total possible scores range from 0 - 10 with higher scores indicating poor functioning, post assault at 6 months|6 months|Only includes participants with complete scale data at 6 months||units on a scale||Standard Deviation|Mean
692325|NCT01430611|Secondary|Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Vaccination of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine|Solicited injection site: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3 injection site: Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥30 mm. Grade 3 systemic reactions: Fever, temperature >39˚C; Headache, Malaise, and Myalgia, Significant, preventing daily activity.|Day 0 up to Day 7 post-vaccination|Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set (SafAS). A Group 2 subject received the wrong vaccine and was included in Full Analysis Set for Group 2 (where classification was per vaccine randomized to) and also Group 1 SafAS (where classification was according to vaccine actually received).||Participants|||Number
692326|NCT01430611|Secondary|Geometric Mean Titers of Serogroup C Antibodies Following Vaccination With Either Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine|Meningococcal Group C antibodies were measured by 2,3,5 triphenyltetrazolium chloride (TTC) serum bactericidal assay using baby rabbit complement (SBA-BR).|Day 0 (pre-vaccination) and Day 30 post-vaccination|Geometric mean titers were assessed in the Per-protocol Analysis Set.||Titers||95% Confidence Interval|Geometric Mean
692327|NCT01430611|Secondary|Geometric Mean Titers of Serogroup A Antibodies Following Vaccination With Either Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine|Meningococcal Group A antibodies were measured by 2,3,5 triphenyltetrazolium chloride (TTC) serum bactericidal assay using baby rabbit complement (SBA-BR).|Day 0 (pre-vaccination) and Day 30 post-vaccination|Geometric mean titers were assessed in the Per-protocol Analysis Set.||Titers||95% Confidence Interval|Geometric Mean
692328|NCT01430611|Secondary|Geometric Mean Titers of Serogroup A and C Antibodies Following Vaccination With Either Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine|Meningococcal Group A and C antibodies were measured by 2,3,5 triphenyltetrazolium chloride (TTC) serum bactericidal assay using baby rabbit complement (SBA-BR).|Day 0 (pre-vaccination) and Day 30 post-vaccination|Geometric mean titers were assessed in the Full Analysis Set.||Titers||95% Confidence Interval|Geometric Mean
692329|NCT01430611|Secondary|Percentage of Participants With Post-vaccination Titer ≥1:8 for Serogroup C Before and Following Vaccination of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine|Meningococcal Group C antibodies were measured by 2,3,5 triphenyltetrazolium chloride (TTC) serum bactericidal assay using baby rabbit complement (SBA-BR)..|Day 0 (pre-vaccination) and Day 30 post-vaccination|Immunogenicity was assessed in the Per Protocol Analysis Set.||Percentage of participants|||Number
692330|NCT01430611|Secondary|Percentage of Participants With Post-vaccination Titer ≥1:8 for Serogroup A Before and Following Vaccination of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine|Meningococcal Group A antibodies were measured by 2,3,5 triphenyltetrazolium chloride (TTC) serum bactericidal assay using baby rabbit complement (SBA-BR)..|Day 0 (pre-vaccination) and Day 30 post-vaccination|Immunogenicity was assessed in the Per Protocol Analysis Set.||Percentage of participants|||Number
692331|NCT01430611|Primary|Number of Participants With Seroconversion Following Vaccination With Either Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine|Seroconversion status was defined as antibody titers against meningococcal serogroups A and C, 30 days after vaccine administration ≥ 4-fold increase from pre-vaccination level measured by 2,3,5 triphenyltetrazolium chloride (TTC) serum bactericidal assay using baby rabbit complement (SBA-BR).|Day 30 post-vaccination|Seroconversion was assessed in the Per-protocol Analysis Set.||Participants|||Number
692332|NCT01430585|Secondary|Number of Participants With Genetic Alterations: Phase 2|Following genetic alterations were planned to be analyzed: mutations in Phosphoinositide 3-kinase, catalytic, alpha (PIK3CA), amplification of PIK3CA, Phosphate and tensin homolog (PTEN) deficiency, and changes in other genes or proteins in, or impacting V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS), Insulin-like Growth Factor 1 Receptor (IGF-1R), phosphatidylinositol 3-kinase (PI3K)/ mammalian target of rapamycin (mTOR) pathway.|Phase 2: Baseline, Week 2, 6|Data was not analyzed due to premature termination of the study. No participant was enrolled in phase 2 of the study.|||||
692333|NCT01430585|Secondary|Change From Baseline in Pharmacodynamic, Cell Proliferation and Survival Biomarkers in Biopsied Tumor Tissue at Week 2 and 6: Phase 2|Change from baseline in following pharmacodynamic parameters were planned to be calculated: expression and/or phosphorylation of Phosphoinositide-3-kinase (PI3K) pathway proteins in biopsied tumor tissue and markers of cell cycle and survival.|Phase 2: Baseline, Week 2, 6|Data was not analyzed due to premature termination of the study. No participant was enrolled in phase 2 of the study.|||||
692358|NCT01430403|Secondary|Spirometry Measurements: Forced Expiratory Volume in 1 Second (FEV1) % Predicted, Treatment Steps 2-5:Omalizumab vs. Placebo|FEV1 is air volume exhaled in 1 second during spirometry. Asthma severity classification for trial: mild--pre-bronchodilator FEV1 ≥ 80% predicted requiring no/ low-moderate dose of inhaled glucocorticoids; moderate--pre-bronchodilator FEV1 <80% predicted requiring no/ low-moderate dose of inhaled glucocorticoids; severe--requiring high-dose inhaled glucocorticoids with/without continuous/near continuous oral glucocorticoids, or uncontrolled despite treatment. FEV1 percent of predicted value is FEV1 converted to a percentage of normal, based on height, weight, and race.|90 Day outcome period|Intent–to-treat||percent predicted FEV1||Standard Error|Mean
692604|NCT01426438|Secondary|Women: Change in HDL Cholesterol|Among women, change in HDL cholesterol (mg/dL) from week 0 to week 24.|0 and 24 weeks|Women in the as-treated analysis population, limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.||mg/dL||Inter-Quartile Range|Median
692334|NCT01430585|Secondary|Pharmacokinetic (PK) Parameters of PF-04691502 and Letrozole: Phase 1B and 2|Phase 1B: Following PK parameters were planned to be calculated from the plasma concentration time data using standard non-compartmental methods. For PF-04691502: area under the curve from time zero to last quantifiable concentration (AUClast), area under the curve from time zero to end of dosing interval (AUCtau), maximum observed plasma concentration (Cmax), minimum observed plasma trough concentration (Cmin), average plasma concentration (Cavg), time to reach maximum observed plasma concentration (Tmax), observed accumulation ratio (Rac [obs]); for letrozole: AUClast, Cmax. Phase 2: Following PK parameters were planned to be calculated for PF-04691502 from the plasma concentration time data using standard non-compartmental methods- AUClast, Cmax and Tmax.|Phase 1B: 0 (pre-dose), 1, 2, 4, 6, 24 hours on Day 1 (letrozole alone), Day 2 (PF-0491502 alone), Day 12, Week 5 (PF-0491502 and letrozole in combination); Phase 2: 0 (pre-dose), 1, 2, 4, 6, 24 hours on Day 1, pre-dose on Week 2, 6|Data for phase 1B was reported in individual participant listings but not statistically summarized for analysis due to premature termination of the study. No participant was enrolled in phase 2 of the study.|||||
692335|NCT01430585|Secondary|Number of Participants With Objective Response (OR): Phase 1B and 2|Number of participants with objective response based on assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as complete disappearance of all target lesions and non-target lesions, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than [<] 10 millimeter [mm]). No appearance of new lesions and normalization of tumor marker levels. PR was defined as greater than or equal to (>=) 30 percent (%) decrease from baseline of the sum of diameters of all target lesions, using the short diameter in the sum for target nodes and the longest diameter in the sum for all other target lesions.|Phase 1B: Baseline, Week 12, end of treatment (Week 34); Phase 2: Baseline, Week 6, 16 or ET|Data for phase 1B was reported in individual participant listings but not statistically summarized for analysis due to premature termination of the study. No participant was enrolled in phase 2 of the study.|||||
692336|NCT01430585|Secondary|Number of Participants With Clinically Significant Abnormalities in Corrected QT (QTc) Interval: Phase 1B||Phase 1B: Baseline up to end of treatment (Week 34)|Data was not analyzed due to premature termination of the study.|||||
692337|NCT01430585|Secondary|Number of Participants With Clinically Significant Abnormalities in Vital Signs: Phase 1B and 2|Vital signs assessments planned to include measurement of blood pressure and heart rate.|Phase 1B: Baseline up to 28 days after last dose of study treatment (Week 34); Phase 2: Baseline up to Week 16 or ET|Data was not analyzed due to premature termination of the study. No participant was enrolled in phase 2 of the study.|||||
692338|NCT01430585|Secondary|Number of Participants With Clinically Significant Laboratory Tests Abnormalities: Phase 1B and 2|Laboratory analysis planned to include blood chemistry, hematology and urinalysis.|Phase 1B: Baseline up to end of treatment (Week 34); Phase 2: Baseline up to Week 16 or early termination (ET)|Data was not analyzed due to premature termination of the study. No participant was enrolled in phase 2 of the study.|||||
692339|NCT01430585|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Phase 2|An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study treatment and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Phase 2: Baseline up to 28 days after last administration of study treatment|Data was not analyzed due to premature termination of the study. No participant was enrolled in phase 2 of the study.|||||
692340|NCT01430585|Primary|Change From Baseline in Ki-67 Percent Positive Tumor Cells in Biopsied Tumor Tissue at Week 6: Phase 2|Nuclear proliferation marker Ki-67 was to be assessed by immunohistochemistry technique in all specimens.|Phase 2: Baseline, Week 6|Data was not analyzed due to premature termination of the study. No participant was enrolled in phase 2 of the study.|||||
692341|NCT01430585|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Phase 1B|An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study treatment and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Phase 1B: Baseline up to 28 days after last administration of study treatment|Safety analysis set included all enrolled participants who started study treatment.||participants|||Number
692342|NCT01430468|Secondary|Intra-operative Photographs|We will use the intra-operative photographs to qualitatively document the surgical steps. These photos may be useful to explain a deviation in the surgery than what would have been expected by the pre-operative simulator.|Post Op CT within 1 year from surgery||||||
692343|NCT01430468|Primary|Comparing Glenoid Component Positioning to Pre Operative Planning|Final implant position will be determined by comparing the position of the glenoid component on the post-operative CT scans with the implant position planned pre-operatively on the surgical simulator. These measurements will be in millimeters and degrees.|1 month post op|||Degrees||Standard Deviation|Mean
692359|NCT01430403|Secondary|Composite Asthma Severity Index (CASI), Treatment Steps 2-4: Omalizumab vs. ICS|CASI scores include 5 domains: day symptoms and albuterol use, night symptoms and albuterol use, controller treatment, lung function measures, and exacerbations. To calculate CASI, the 5 domain scores are summed to determine a final score, which can range from 0 to 20, with 0 being no severity of asthma and 20 being extremely severe asthma.|90 Day outcome period|Intent-to-treat with available CASI scores||CASI Score||Standard Error|Mean
692360|NCT01430403|Secondary|Composite Asthma Severity Index (CASI), Treatment Steps 2-5: Omalizumab vs. Placebo|CASI scores include 5 domains: day symptoms and albuterol use, night symptoms and albuterol use, controller treatment, lung function measures, and exacerbations. To calculate CASI, the 5 domain scores are summed to determine a final score, which can range from 0 to 20, with 0 being no severity of asthma and 20 being extremely severe asthma.|90 Day outcome period|Intent–to-treat||CASI Score||Standard Error|Mean
692344|NCT01430403|Secondary|Comparison of Home Allergen (Cockroach) Exposure and Asthma Exacerbations: Omalizumab Versus Placebo|Residential environmental exposure to cockroach allergen of participants in the context of the risk of asthma exacerbations and effect of omalizumab versus placebo (control) on asthma exacerbations was explored. Presence of cockroach allergen in household dust samples was assessed. Exacerbation defined as: participant required either 1.)a prescribed course of systemic steroids by a clinician2.)initiation of a course of systemic steroids or 3.)a hospitalization during the fall outcome period (90 day period beginning on the first day of the participant's school year) to prevent a serious asthma outcome. In cases that a participant initiated and completed a course of systemic steroids without clinician involvement, the course was counted as an exacerbation only with fulfillment of the following minimum dosage: prednisone, prednisolone, or methylprednisolone at ≥20mg per day for 3 of any 5 consecutive days; or dexamethasone at ≥10mg per day for ≥1 day).|90 Day outcome period|"Prespecified Outcome Measure: analysis limited to the Omalizumab and Placebo Groups.
Analysis: intent-to-treat (with available data)."||Participants|||Count of Participants
692345|NCT01430403|Secondary|Percent Adherence to Asthma Medication, Treatment Steps 2-4: Omalizumab vs. ICS|Adherence to the study regimen and other asthma treatments, assessed as percent of expected dose taken, by means of study interviews and study physician corroboration.|90 Day outcome period|Intent-to-treat||percent adherence||Standard Error|Mean
692346|NCT01430403|Secondary|Percent Adherence to Asthma Medication, Treatment Steps 2-5: Omalizumab vs. Placebo|Adherence to the study regimen and other asthma treatments, assessed as percent of expected dose taken, by means of study interviews and study physician corroboration.|90 Day outcome period|Intent–to-treat||percent adherence||Standard Error|Mean
692347|NCT01430403|Secondary|School Absences (Percent), Treatment Steps 2-4: Omalizumab vs. ICS|The ratio of the number of school days missed over the numbers of school days in session|90 Day outcome period|Intent-to-treat||Ratio||Standard Error|Mean
692348|NCT01430403|Secondary|School Absences (Percent), Treatment Steps 2-5:Omalizumab vs. Placebo|The ratio of the number of school days missed over the numbers of school days in session|90 Day outcome period|Intent–to-treat||Ratio||Standard Error|Mean
692349|NCT01430403|Secondary|Work Disruptions Due to Child’s Asthma, Treatment Steps 2-4: Omalizumab vs. ICS|The ratio of the work hours missed due to child’s asthma over the numbers of work hours in the past 14 days among caretakers working|90 Day outcome period|Intent-to-treat with available data||Ratio||Standard Error|Mean
692350|NCT01430403|Secondary|Work Disruptions Due to Child’s Asthma, Treatment Steps 2-5: Omalizumab vs. Placebo|The ratio of the work hours missed due to child’s asthma over the numbers of work hours in the past 14 days among caretakers working.|90 Day outcome period|Intent–to-treat with available data||Ratio||Standard Error|Mean
692351|NCT01430403|Secondary|Asthma Control Test Score: Child Asthma Control Test (C-ACT), Treatment Steps 2-4: Omalizumab vs. ICS|The Childhood Asthma Control Test (C-ACT) is a validated tool to assess overall asthma control (over the last 4 weeks) in patients ages 4 to 11 years. Scores can range from 0 to 27. A score of 19 or less is indicative of asthma that is not well controlled. The minimally important difference in C-ACT scores is not defined.|90 Day outcome period|Intent-to-treat with available C-ACT Scores||C-ACT Score||Standard Error|Mean
692352|NCT01430403|Secondary|Asthma Control Test Score: Child Asthma Control Test (C-ACT), Treatment Steps 2-5: Omalizumab vs. Placebo|The Childhood Asthma Control Test (C-ACT) is a validated tool to assess overall asthma control (over the last 4 weeks) in patients ages 4 to 11 years. Scores can range from 0 to 27. A score of 19 or less is indicative of asthma that is not well controlled. The minimally important difference in C-ACT scores is not defined|90 Day outcome period|Intent–to-treat with available C-ACT Scores||C-ACT Score||Standard Error|Mean
692353|NCT01430403|Secondary|Asthma Control Test Scores: Asthma Control Test (ACT), Treatment Steps 2-4: Omalizumab vs. ICS|The Asthma Control Test (ACT) is a validated tool to assess asthma control (over the last 4 weeks) in patients ≥12 yrs old. It is comprised of 5 questions assessing symptoms, use of rescue medications, and the impact of asthma on everyday functioning. All questions are scored on a 5-point Likert scale (higher score indicating better control). Total scores can range from 5-25. A score of ≤19 is indicative of not well-controlled asthma. The minimally important difference is 3 points.|90 Day outcome period|Intent-to-treat with available ACT Scores||ACT Score||Standard Error|Mean
692354|NCT01430403|Secondary|Asthma Control Test Scores: Asthma Control Test (ACT), Treatment Steps 2-5: Omalizumab vs. Placebo|Outcome measure description: The Asthma Control Test (ACT) is a validated tool to assess asthma control (over the last 4 weeks) in patients ≥12 yrs old. It is comprised of 5 questions assessing symptoms, use of rescue medications, and the impact of asthma on everyday functioning. All questions are scored on a 5-point Likert scale (higher score indicating better control). Total scores can range from 5-25. A score of ≤19 is indicative of not well-controlled asthma. The minimally important difference is 3 points.|90 Day outcome period|Intent–to-treat with available ACT scores||ACT Score||Standard Error|Mean
692355|NCT01430403|Secondary|Spirometry Measurements: FEV1:FVCx100, Treatment Steps 2-4: Omalizumab vs. ICS|The FEV1 (forced expiratory volume 1))/ FVC (forced vital capacity) ratio is used to evaluate airways obstructions since pure restrictive ventilatory defects cause an equal reduction in the FEV1 and the FVC. An FEV1/FVC ratio below 80% indicates airflow obstruction. Normal FEV1/FVC: 8 – 19 years of age=85%.|90 Day outcome period|Intent-to-treat||percent FEV1/FVC ratio||Standard Error|Mean
692356|NCT01430403|Secondary|Spirometry Measurements: FEV1:FVCx100, Treatment Steps 2-5: Omalizumab vs. Placebo|The FEV1 (forced expiratory volume 1))/ FVC (forced vital capacity) ratio is used to evaluate airways obstructions since pure restrictive ventilatory defects cause an equal reduction in the FEV1 and the FVC. An FEV1/FVC ratio below 80% indicates airflow obstruction. Normal FEV1/FVC: 8 – 19 years of age=85%.|90 Day outcome period|Intent–to-treat||percent FEV1/FVC ratio||Standard Error|Mean
692357|NCT01430403|Secondary|Spirometry Measurements: Forced Expiratory Volume in 1 Second (FEV1) % Predicted , Treatment Steps 2-4: Omalizumab vs. ICS|FEV1 is air volume exhaled in 1 second during spirometry. Asthma severity classification for trial: mild--pre-bronchodilator FEV1 ≥ 80% predicted requiring no/ low-moderate dose of inhaled glucocorticoids; moderate--pre-bronchodilator FEV1 <80% predicted requiring no/ low-moderate dose of inhaled glucocorticoids; severe--requiring high-dose inhaled glucocorticoids with/without continuous/near continuous oral glucocorticoids, or uncontrolled despite treatment. FEV1 percent of predicted value is FEV1 converted to a percentage of normal, based on height, weight, and race.|90 Day outcome period|Intent-to-treat||percent predicted FEV1||Standard Error|Mean
692361|NCT01430403|Secondary|Number of Exacerbations Evaluated Monthly With Viral Respiratory Infections: Omalizumab vs. Placebo|Asthma exacerbation is defined as a prescribed course of systemic steroids by a clinician or initiation of a course of systemic steroids by a participant or a hospitalization during the fall outcome period (90 day period beginning on the first day of the participant's school year) to prevent a serious asthma outcome. If a participant initiates and completes a course of systemic steroids without clinician involvement, this course will be counted only if it meets the following minimum dosage: prednisone, prednisolone, or methylprednisolone at ≥20mg per day for 3 of any 5 consecutive days; or dexamethasone at ≥10mg per day for ≥1 day. The hypothesis behind this outcome measure is that omalizumab will change virology; thus, the intent of this measure was to assess the comparator group of placebo against omalizumab.|90 Day outcome period|"The pre-specified intent for Outcome Measure: analysis inclusion limited to the Omalizumab and Placebo Groups.
Analysis: intent-to-treat (with available data)."||Total Number of Viral Infections||Standard Error|Mean
692362|NCT01430403|Secondary|Severity of Asthma Symptoms Associated With a Viral Infection:Omalizumab vs. Placebo|Severity asthma symptoms is defined as the highest value among the following 3 variables: number of days with wheezing, tightness in the chest, or cough; number of nights with disturbed sleep as a result of asthma; and number of days on which a participant had to slow down or discontinue play/physical activities over a two week period associated with a viral infection. This outcome looks at the effect by group on number of days with asthma symptoms and infections. The hypothesis behind this outcome measure is that omalizumab will change virology; thus, the the intent of this measure was to assess the comparator group of placebo against omalizumab|90 Day outcome period|"The pre-specified intent for Outcome Measure: analysis inclusion limited to the Omalizumab and Placebo Groups.
Analysis: intent-to-treat (with available data)."||Maximum Symptoms Days||Standard Error|Mean
692363|NCT01430403|Secondary|Virus-induced Exacerbations as Measured by an Exacerbation That is Associated With a Virus Detected Using the Nasal Mucus Samples|Asthma exacerbation:defined by a prescribed course of systemic steroids by a clinician or initiation of a course of systemic steroids by a participant or a hospitalization during the fall outcome period (90 day period beginning on the 1st day of the participant's school year) to prevent a serious asthma outcome. If a participant initiates and completes a course of systemic steroids without clinician involvement, this course will be counted only if it meets the following minimum dosage: prednisone, prednisolone, or methylprednisolone at ≥ 20mg per day for 3 of any 5 consecutive days; or dexamethasone at ≥ 10mg per day for ≥1 day. Exacerbations were then associated with viral respiratory infections based on nasal mucus samples collected monthly. Nasal mucus samples were categorized as having exacerbations or not having exacerbations. Participants could potentially be counted in each group, as participants could have samples with exacerbations and samples without exacerbations.|90 Day outcome period|Nasal mucus samples||Percent Samples with virus|Number of Samples Analyzed||Number
692364|NCT01430403|Primary|Occurrence of One or More Asthma Exacerbations (Treatment Steps 2-4)|Asthma exacerbation defined as a prescription of a course of systemic steroids by a clinician or initiation of a course of systemic steroids by a participant or a hospitalization during the fall outcome period (90 day period beginning on the first day of the participant's school year) to prevent a serious asthma outcome. If a participant initiates and completes a course of systemic steroids without clinician involvement, this course will be counted only if it meets the following minimum dosage: prednisone, prednisolone, or methylprednisolone at ≥20mg per day for 3 of any 5 consecutive days; or dexamethasone at ≥10mg per day for ≥1 day. Odds ratio comparing Inhaled corticosteroid boost therapy (ICS) and Omalizumab arms at Treatment Steps 2-4.|90 Day outcome period|Intent-to-treat||Percent of adjusted prevalence|||Number
692365|NCT01430403|Primary|Occurrence of One or More Asthma Exacerbations (All Treatment Steps [Steps 2-5])|Asthma exacerbation defined as a prescribed course of systemic steroids by a clinician or initiation of a course of systemic steroids by a participant or a hospitalization during the fall outcome period (90 day period beginning on the first day of the participant's school year) to prevent a serious asthma outcome. If a participant initiates and completes a course of systemic steroids without clinician involvement, this course will be counted only if it meets the following minimum dosage: prednisone, prednisolone, or methylprednisolone at ≥ 20mg per day for 3 of any 5 consecutive days; or dexamethasone at ≥10mg per day for ≥1 day. Odds ratio comparing Placebo and Omalizumab arms across all treatment steps (Steps 2-5).|90 Day outcome period|Intent–to-treat||Percent of adjusted prevalence|||Number
692366|NCT01430325|Primary|Participant Perception of Breathing Gas|Percent of participants in each arm guessing that their breathing gas was 100% oxygen.|Within 15 minutes of chamber excursion|40 of 42 participants provided an answer to this question.||percentage of participants|||Number
692367|NCT01430325|Primary|Participant Perception of Depth|Mean depth perception for participants providing a free response.|Within 15 minutes of chamber excursion|"23 of 42 participants provided a numerical response. The remainder selected I do not know."||fsw||Standard Deviation|Mean
692368|NCT01430325|Primary|"Participants Indicating I do Not Know on Depth Questionnaire."|"Participants indicating I do not know on depth questionnaire instead of providing a free response guess."|Within 15 minutes of chamber excursion|All participants who enrolled in the study were analyzed.||participants|||Number
692369|NCT01430182|Primary|Opioid Consumption|Number of morphine equivalents used by subject during first 24 hours after discharge from Post-Anesthesia Care Unit|First 24 hours after discharge from Post-Anesthesia Care Unit|||mg of morphine IV equivalents||Standard Deviation|Mean
692370|NCT01430169|Primary|AUX-II Tmax After Injection 2|Time to maximum AUX-II enzyme concentration. AUX-II plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).|15 minutes before Injection 2 (24 hours after Injection 1 or 0 hour for Injection 2); 5, 10, 20, and 30 minutes after Injection 2; 1, 2, 4, 8, and 12 hours after Injection 2; Day 3 (24 hours after Injection 2)|Pharmacokinetic (PK) population (N=19) In addition, 2 subjects have been excluded from the analysis due to ELISA interference. Of the 38 AUX-II profiles,23 had no quantifiable plasma concentrations at any time point through 24 hours post injection.||hours||Standard Deviation|Mean
692399|NCT01429623|Secondary|Change in Disability Assessment in Dementia for Ladostigil Versus Placebo Population|Mean value change (from baseline) in Disability Assessment in Dementia (DAD) across entire study period. DAD evaluates the basic and instrumental activities in daily activities of elderly people with dementia. Higher scores reflect better functioning. DAD ranges from 0 to 100.|3,6,12,18,24,30 and 36 months|||Change from basline on units on a scale||Standard Deviation|Mean
692371|NCT01430169|Primary|AUX-I Tmax After Injection 2|Time to maximum AUX-I enzyme concentration. AUX-I plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).|15 minutes before Injection 2 (24 hours after Injection 1 or 0 hour for Injection 2); 5, 10, 20, and 30 minutes after Injection 2; 1, 2, 4, 8, and 12 hours after Injection 2; Day 3 (24 hours after Injection 2)|"Pharmacokinetic (PK) population (N=19). In addition, 2 subjects have been excluded from the analysis due to ELISA interference.
Of the 38 AUX-I profiles, 7 had no quantifiable plasma concentrations through 24 hours post injection."||hour||Standard Deviation|Mean
692372|NCT01430169|Primary|AUX-II AUC0-tlast After Injection 2|Area under the curve from zero to tlast within 24 hours after the Injection 2, where tlast is time to last time with a quantifiable concentration of the enzyme AUX-II. AUX-II plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).|15 minutes before Injection 2 (24 hours after Injection 1 or 0 hour for Injection 2); 5, 10, 20, and 30 minutes after Injection 2; 1, 2, 4, 8, and 12 hours after Injection 2; Day 3 (24 hours after Injection 2)|Pharmacokinetic (PK) population (N=19)||ng*h/mL||Standard Deviation|Mean
692373|NCT01430169|Primary|AUX-I AUC0-tlast After Injection 2|Area under the curve from zero to tlast within 24 hours after the Injection 2, where tlast is time to last time with a quantifiable concentration of the enzyme AUX-I. AUX-I plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).|15 minutes before Injection 2 (24 hours after Injection 1 or 0 hour for Injection 2); 5, 10, 20, and 30 minutes after Injection 2; 1, 2, 4, 8, and 12 hours after Injection 2; Day 3 (24 hours after Injection 2)|Pharmacokinetic (PK) population (N=19). Two subjects were excluded from the analysis due to bioanalytical reasons (ELISA interference)||ng*h/mL||Standard Deviation|Mean
692374|NCT01430169|Primary|AUX-II Cmax After Injection 2|Maximum AUX-II enzyme concentration from zero to 24 hours after Injection 2. AUX-II plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).|15 minutes before Injection 2 (24 hours after Injection 1 or 0 hour for Injection 2); 5, 10, 20, and 30 minutes after Injection 2; 1, 2, 4, 8, and 12 hours after Injection 2; Day 3 (24 hours after Injection 2)|Pharmacokinetic (PK) population (N=19)||ng/mL||Standard Deviation|Mean
692375|NCT01430169|Primary|AUX-I Cmax After Injection 2|Maximum AUX-I enzyme concentration from zero to 24 hours after Injection 2.AUX-I plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).|15 minutes before Injection 2 (24 hours after Injection 1 or 0 hour for Injection 2); 5, 10, 20, and 30 minutes after Injection 2; 1, 2, 4, 8, and 12 hours after Injection 2; Day 3 (24 hours after Injection 2)|Pharmacokinetic (PK) population (N=19). Two subjects were excluded from the analysis due to bioanalytical reasons (ELISA interference)||ng/mL||Standard Deviation|Mean
692376|NCT01430169|Primary|AUX-II Tmax After Injection 1|Time to maximum AUX-II enzyme concentration. AUX-II plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).|15 minutes before Injection 1 (0 hour for Injection 1); 5, 10, 20, and 30 minutes after Injection 1; 1, 2, 4, 8, and 12 hours after Injection 1; 15 minutes before Injection 2 (24 hours after Injection 1)|Pharmacokinetic (PK) population (N=19) One subject was excluded from AUX-II PK analyses due to insufficient quantities of plasma for bioanalysis. Of the 38 AUX-II profiles, 23 had no quantifiable plasma concentrations at any time point through 24 hours post injection.||hours||Standard Deviation|Mean
692377|NCT01430169|Primary|AUX-I Tmax After Injection 1|Time to maximum AUX-I enzyme concentration. AUX-I plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).|15 minutes before Injection 1 (0 hour for Injection 1); 5, 10, 20, and 30 minutes after Injection 1; 1, 2, 4, 8, and 12 hours after Injection 1; 15 minutes before Injection 2 (24 hours after Injection 1)|Pharmacokinetic (PK) population (N=19). For 3 subjects Tmax was considered missing if concentration was BLQ for all time points at that injection and 2 subjects were excluded from the analysis due to bioanalytical reasons (ELISA interference)||hours||Standard Deviation|Mean
692378|NCT01430169|Primary|AUX-II AUC0-tlast After Injection 1|Area under the curve from pre-injection to tlast within 24 hours after the Injection 1, where tlast is time to last time with a quantifiable concentration of the enzyme AUX-II. AUX-II plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).|15 minutes before Injection 1 (0 hour for Injection 1); 5, 10, 20, and 30 minutes after Injection 1; 1, 2, 4, 8, and 12 hours after Injection 1; 15 minutes before Injection 2 (24 hours after Injection 1)|Pharmacokinetic (PK) population (N=19)||ng*h/mL||Standard Deviation|Mean
692379|NCT01430169|Primary|AUX-I AUC0-tlast After Injection 1|Area under the curve from pre-injection to tlast within 24 hours after the Injection 1, where tlast is time to last time with a quantifiable concentration of the enzyme AUX-I. AUX-I plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).|15 minutes before Injection 1 (0 hour for Injection 1); 5, 10, 20, and 30 minutes after Injection 1; 1, 2, 4, 8, and 12 hours after Injection 1; 15 minutes before Injection 2 (24 hours after Injection 1)|Pharmacokinetic population (N=19). Two subjects were excluded from the analysis due to bioanalytical reasons (ELISA interference)||ng*h/mL||Standard Deviation|Mean
692380|NCT01430169|Primary|AUX-II Cmax After Injection 1|Maximum AUX-II (clostridium Type II collagenase) enzyme concentration from pre-injection to 24 hours after Injection 1. AUX-II plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).|15 minutes before Injection 1 (0 hour for Injection 1); 5, 10, 20, and 30 minutes after Injection 1; 1, 2, 4, 8, and 12 hours after Injection 1; 15 minutes before Injection 2 (24 hours after Injection 1)|Pharmacokinetic (PK) population (N=19).||ng/mL||Standard Deviation|Mean
692381|NCT01430169|Primary|AUX-I Cmax After Injection 1|Maximum AUX-I (clostridial type I collagenase) enzyme concentration from pre-injection to 24 hours after Injection 1. AUX-I plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).|15 minutes before Injection 1 (0 hour for Injection 1); 5, 10, 20, and 30 minutes after Injection 1; 1, 2, 4, 8, and 12 hours after Injection 1; 15 minutes before Injection 2 (24 hours after Injection 1)|Pharmacokinetic (PK) population (N=19). Two subjects were excluded from the analysis due to bioanalytical reasons (ELISA interference)||ng/mL||Standard Deviation|Mean
692382|NCT01430130|Secondary|Comparison of Scar Smoothness of Treated Side as Compared to the Control Side||Up to 12 months||||||
692383|NCT01430130|Secondary|Comfort Level Related to Study Device Application, Wear and Removal||Up to 12 weeks||||||
692384|NCT01430130|Secondary|Ease of Use||Up to 12 months||||||
692385|NCT01430130|Secondary|Subject and Investigator Satisfaction With the Aesthetic Results||Up to 12 months||||||
692386|NCT01430130|Primary|Visual Analogue Scale (VAS)|"Visual Analogue Scale Scar Score (VAS Scar Score) was defined and validated by Duncan et al 2006[1]. This scale consists of a 10cm line representing scar quality, with 0 representing normal skin and 10 indicating a poor scar. The assessor places a mark along the line to represent the appearance of the scar. This mark is translated into a score by measuring its position on the 10cm line to one decimal place. The independent panel used this to scale the primary outcome.
[1] Duncan J, Bond J, Mason T, Ludlow A, Cridland P, O’Kane S and Ferguson M. Visual Analogue Scale Scoring and Ranking: A Suitable and Sensitive Method for Assessing Scar Quality? Plast. Reconstr. Surg. 118: 909, 2006."|6 months|Per protocol, all eligible patients who did not exit the study prematurely.||Units on a scale||Standard Error|Mean
692387|NCT01430104|Secondary|Concentrations of Serum 1,25-Hydroxy-2-Vitamin D3||Day 1 (Predose, 28-day Teriparatide Treatment Period) and Day 8 and Day 15 and Day 29 (Follow-up Period) and Day 35 (Follow-up Period)|All enrolled participants who received at least 1 dose of Teriparatide and had at least 1 postdose serum 1,25-Hydroxy-Vitamin D3 assessment were included in the analysis.||picogram per milliliter (pg/mL)||Standard Deviation|Mean
692388|NCT01430104|Secondary|Concentrations of Serum 25-Hydroxy-Vitamin D||Day 1 (Predose, 28-day Teriparatide Treatment Period) and Day 8 and Day 15 and Day 29 (Follow-up Period) and Day 35 (Follow-up Period)|All enrolled participants who received at least 1 dose of Teriparatide and had at least 1 postdose serum 25-Hydroxy-Vitamin D assessment were included in the analysis.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
692389|NCT01430104|Secondary|Change From Baseline in Daily Urine Calcium Excreted||Day 1, Day 7, Day 14, Day 28 (28-day Teriparatide Treatment Period)|All enrolled participants who received at least 1 dose of Teriparatide, had a baseline urine calcium assessment, and at least 1 postdose urine calcium assessment were included in the analysis.||grams per day (g/day)||Standard Deviation|Mean
692390|NCT01430104|Secondary|Mean Daily Urine Calcium Excreted||Day 1 and Day 7 and Day 14 and Day 28 (28-day Teriparatide Treatment Period)|All enrolled participants who received at least 1 dose of Teriparatide and had at least 1 postdose urine calcium assessment were included in the analysis.||grams per day (g/day)||Standard Deviation|Mean
692391|NCT01430104|Secondary|Number of Participants With Daily Urine Calcium Excreted Over 0.3 Grams Per Day (g/Day) at Any Time Postbaseline|Urine calcium levels presented are for any day during the 28-day Teriparatide Treatment Period.|Day 1 up to Day 28 (28-day Teriparatide Treatment Period)|All enrolled participants who received at least 1 dose of Teriparatide and had at least 1 postdose urine calcium assessment were included in the analysis.||participants|||Number
692392|NCT01430104|Secondary|Change From Baseline in Serum Calcium|Corrected calcium (milligram per deciliter [mg/dL]) = total serum calcium concentration (mg/dL) + 4.0 – serum albumin concentration (grams per deciliter [g/dL]). The Least Squares (LS) means were controlled for Day, Timepoint, Day*Timepoint, and random error. Postdose refers to after Teriparatide dose.|Baseline (Day -1 of the 14-day Lead-in Period), Day 1, Day 7, Day 14, Day 28 at 0 hours (h), 2 h, 4 h, 6 h, 16 h, and 24 h postdose (28-day Teriparatide Treatment Period)|All enrolled participants who complied received at least 1 dose of Teriparatide, completed all protocol requirements, and had at least 1 postdose serum calcium assessment were included in the analysis.||mg/dL||90% Confidence Interval|Least Squares Mean
692393|NCT01430104|Secondary|Mean Serum Calcium Levels|Daily profiles of corrected mean serum calcium levels were determined for each participant. Corrected calcium (milligram per deciliter [mg/dL]) = total serum calcium concentration (mg/dL) + 4.0 – serum albumin concentration (grams per deciliter [g/dL]). The Least Squares (LS) means were adjusted for Day, Timepoint, Day*Timepoint, and random error. At baseline, participants received only Aspara-CA and Alfarol supplements and the timepoints were based on the times before Aspara-CA and Alfarol administration (predose) and after Aspara-CA and Alfarol administration (postdose). During the 28-day Teriparatide Treatment Period, timepoints were based on before Teriparatide administration (predose) and after Teriparatide administration (postdose).|Baseline (Day -1 of 14-day Lead-in Period) and Day 1 and Day 7 and Day 14 and Day 28 at 0 hours (h), 2 h, 4 h, 6 h, 16 h, and 24 h postdose (28-day Teriparatide Treatment Period)|All enrolled participants who received at least 1 dose of Teriparatide, completed all protocol requirements, and had at least 1 postdose serum calcium assessment were included in the analysis.||mg/dL||90% Confidence Interval|Least Squares Mean
692394|NCT01430104|Secondary|Number of Participants With Serum Calcium Level Over 11.0 Milligrams Per Deciliter (mg/dL) and 13.5 mg/dL, Respectively at Any Time Postbaseline|Total serum calcium concentration adjusted by serum albumin concentration. Corrected calcium (mg/dL) = total serum calcium concentration (mg/dL) + 4.0 – serum albumin concentration (grams per deciliter [g/dL]). Serum calcium levels presented are for any time postdose on any day during the 28-day Teriparatide Treatment Period.|Day 1 up to Day 28 (Teriparatide Treatment Period)|All enrolled participants who received at least 1 dose of Teriparatide and had at least 1 postdose serum calcium assessment were included in the analysis.||participants|||Number
692395|NCT01430104|Primary|Number of Participants With Serum Calcium Level Over 11.0 Milligrams Per Deciliter (mg/dL)|Total serum calcium concentration adjusted by serum albumin concentration. Corrected calcium (mg/dL) = total serum calcium concentration (mg/dL) + 4.0 – serum albumin concentration (grams per deciliter [g/dL]). Postdose refers to after Teriparatide dose.|Day 28 (16 and 24 hours postdose)|All enrolled participants who received at least 1 dose of Teriparatide and had either a 16-hour or 24-hour postdose serum calcium assessment on Day 28 were included in the analysis.||participants|||Number
692396|NCT01430091|Primary|Pharmacokinetics: Time of Maximum Concentration (Tmax) of Prasugrel’s Active Metabolite (PRAS-AM)||Pre-dose up to 8 hours post-dose after each treatment|Pharmacokinetic analyses were conducted on the full analysis set, which included all data from all randomized participants receiving at least 1 dose of prasugrel.||hours||Full Range|Median
692397|NCT01430091|Primary|Pharmacokinetics: Maximum Concentration (Cmax) of Prasugrel’s Active Metabolite (PRAS-AM)||Pre-dose up to 8 hours post-dose after each treatment|Pharmacokinetic analyses were conducted on the full analysis set, which included all data from all randomized participants receiving at least 1 dose of prasugrel.||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
692398|NCT01430091|Primary|Pharmacokinetics: Area Under the Concentration-Time Curve From Time Zero to the Last Measureable Concentration (AUC[0-tlast]) of Prasugrel’s Active Metabolite (PRAS-AM)||Pre-dose up to 8 hours post-dose after each treatment|Pharmacokinetic analyses were conducted on the full analysis set, which included all data from all randomized participants receiving at least 1 dose of prasugrel.||nanogram * hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
692400|NCT01429623|Secondary|Change in Neuropsychiatric Test Battery for Ladostigil Versus Placebo Population|Mean value change (from baseline) in Neuropsychiatric Test Battery (NTB) across entire study period. The NTB included the following well known cognitive tests: Rey Auditory Verbal Learning Test (RAVLT), Controlled Word Association Test (COWAT), Category Fluency Test (CFT), WMS-R Digit Span, and Trail Making Part A and B. The mean value was comprised of the z score of each of these tests with all z scores in the direction of higher scores better functioning. Range -3 to +3.|3,6,12,18,24,30 and 36 months|Modified Intent to treat (all randomized subject with at least one post baseline assessment)||Change from basline on units on a scale||Standard Deviation|Mean
692401|NCT01429623|Secondary|Change in Geriatric Depression Scale for Ladostigil Versus Placebo Population|"Mean value change (from baseline) in Geriatric Depression Scale (GDS) across entire study period. The GDS ranges from 0 to 30. Scores of 0-9 are considered normal, 10-19 mildly depressed, and 20-30 severely depressed."|3,6,12,18,24,30 and 36 months|Modified Intent to Treat||Change from basline on units on a scale||Standard Deviation|Mean
692402|NCT01429623|Primary|Conversion From Mild Cognitive Impairment to Alzheimer's Disease Compared to Placebo|"Total number of conversions from Mild Cognitive Impairment to Alzheimer's disease across entire 3 year study period. Conversion is determined, or defined, by a Clinical Dementia Rating (CDR) score of greater than or equal to one.
Composite rating ranges from 0 no symptoms of dementia to 3 Severe symptoms of dementia."|3,6,12,18,24,30 and 36 months|All randomized subjects with at least one post-baseline visit.||Participants|||Count of Participants
692403|NCT01429584|Secondary|Satisfaction With Pain Control|A follow-up phone call was made to patients within 30 days of surgery to assess the presence of any complications related to the block and overall satisfaction with pain control. Overall satisfaction was assessed on a 7-point Likert scale of 1-not at all satisfied with pain control 2-mostly unsatisfied with pain control 3-slightly unsatisfied with pain control 4-no opinion 5-slightly satisfied with pain control 6-mostly satisfied with pain control 7-completely satisfied with pain control.|Within 30 days|Same as other outcome measures||Likert Satisfaction Scale||Standard Deviation|Mean
692404|NCT01429584|Secondary|Pain Relief|Pain relief was assessed by recording the amount of opioid administered intraoperatively and in the PACU. The Visual Analogue Score of pain scores (0-10, with 0 being no pain and 10 being the worst pain imaginable) were recorded at the time of discharge from the PACU, within 5 hours of the completion of surgery.|At discharge from the post-anesthesia care unit, within 5 hours of the completion of surgery|Same as other outcome measures.||Visual Analogue Scale for pain||Standard Deviation|Mean
692405|NCT01429584|Primary|Abnormal Lung Function|Lung function was evaluated by examining diaphragm movement using ultrasound imaging and change in room air oxygen saturation (SpO2). Diaphragm movement was assessed using ultrasound as Normal (diaphragm moves caudad with inspiration), Abnormal (diaphragm does not move caudad with inspiration), and Paradoxical (diaphragm moves cephalad with inspiration). Both diaphragm function and room air SpO2 were assessed prior to any intervention to establish a baseline, and again on discharge from the PACU, within 5 hours of the completion of surgery.|At discharge from the post-anesthesia care unit, within 5 hours of the completion of surgery|Power analysis was performed and a drop-out rate of 10% was anticipated.||participants w/ abnormal diaphragm fxn|||Number
692406|NCT01429532|Primary|Surgically Induced Astigmatism|Corneal astigmatism was measured using an eye scanner (Pentacam; Oculus, Wetzlar, Germany), and the SIA was calculated at each postoperative visit using the following equation.|post-operative week 1, post-operative month 1, and post-operative month 3|||Diopters||Standard Deviation|Mean
692407|NCT01429532|Secondary|Best-corrected Visual Acuity|The best-corrected visual acuity (BCVA) was measured, using an ETDRS chart and auto-refraction as refined by an ophthalmologist, preoperatively and at postoperative 1 day, 1 week, 1 month and 3 months.|post-operative week 1, post-operative month 1, and post-operative month 3|The SPSS software package (version 17.0, SPSS Inc, Chicago, IL, USA) was used for statistical analysis.||logMAR||Standard Deviation|Mean
692408|NCT01429532|Primary|Central Cornea Endothelial Cell Loss|Central cornea endothelial cell loss was calculated on the basis of preoperative and postoperative endothelial cell density.|post-operative week 1, post-operative month 1, and post-operative month 3|The SPSS software package (version 17.0, SPSS Inc, Chicago, IL, USA) was used for statistical analysis and sample size calculation. Mean ultrasound time (UST), surgical time, cumulative dissipated energy (CDE), total BSS volume, and SIA were compared using multifactor analysis of variance.||% of endothelial cell loss||Standard Deviation|Mean
692409|NCT01429441|Secondary|Proportion of Subjects With a ≥2 Lines Improvement in Best-corrected Visual Acuity (BCVA) From Baseline at Month 24|≥2 lines improvement in BCVA from baseline, irrespective of vitrectomy. Missing data were imputed using the LOCF method.|Month 24|FAS. 1 subject did not have BCVA results at baseline and was excluded from this analysis.||Percentage (weighted across strata)||95% Confidence Interval|Number
692410|NCT01429441|Primary|Proportion of Subjects With Pharmacological Vitreomacular Adhesion (VMA) / (Vitreomacular Traction [VMT]) Resolution at Day 28|Pharmacological VMA resolution without anatomical defect, based on SD-OCT and determined by the masked central reading center (CRC), with post-resolution vitrectomy considered as a failure. Missing data were imputed using the last observation carried forward (LOCF) method.|Day 28|Full Analysis Set (FAS): The FAS is the set of all randomized subjects who received the initial treatment, and for whom data of at least 1 post-injection efficacy assessment was present. Two (2) subjects (1 in each treatment group) were excluded from the FAS as they withdrew consent and did not attend any of the post-injection visits.||Percentage (weighted across strata)||95% Confidence Interval|Number
692411|NCT01429259|Secondary|Meropenem Pharmacodynamics|Meropenem exposures defined from the population model for each participant will be analyzed as a function of the isolated pathogens meropenem minimum inhibitory concentration (MIC) to define the exposure of meropenem associated with an absolute and relative percent change in the Forced Expiratory Volume (FEV1).|14-21 days||||||
692412|NCT01429259|Secondary|Practicality of 3 Hour Prolonged Infusion|This will be an intention to treat analysis of all 30 participants receiving meropenem as a 3 hour prolonged infusion. The Cystic Fibrosis Questionnaire-Revised (CFQ-R) will be utilized to assess patient or parent assessments of the burden of the prolonged infusion treatment. The CFQ-R will be administered at the beginning of the study and then within 7 days after completion of meropenem therapy.|14-21 days||||||
692605|NCT01426438|Secondary|Men: Change in HDL Cholesterol|Among men, change in HDL Cholesterol (mg/dL) from week 0 to week 24.|0 and 24 weeks|Men in the as-treated analysis population, limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.||mg/dL||Inter-Quartile Range|Median
692413|NCT01429259|Secondary|Safety|This will be an intention to treat analysis of all 30 participants receiving meropenem as a 3 hour prolonged infusion. Participants will be monitored for any sign of symptom of adverse events throughout the course of the study. An adverse event will be defined as any pathologic or unintended change in the structure (signs), function (symptoms), or chemistry (laboratory values) of the body associated with the use of the study drug.|14-21 days||||||
692414|NCT01429259|Primary|Population Pharmacokinetics - Volume of Central Compartment|Based on meropenem concentrations, the pharmacokinetics of the study population will be analyzed to determine each patient's volume of the central compartment.|During 8 hour dosing interval after 3rd meropenem dose|||L/kg||Standard Deviation|Mean
692415|NCT01429259|Primary|Population Pharmacokinetics - Total Body Clearance|Based on meropenem concentrations, the pharmacokinetics of the study population will be analyzed to determine each patient's total body clearance.|8 hour dosing interval after 3rd meropenem dose|||L/hr/kg||Standard Deviation|Mean
692416|NCT01429077|Secondary|Participation in Everyday Activities (Maintenance)||Change in participation in everyday activities from 6 weeks to 12 weeks||||||
692417|NCT01429077|Secondary|Functional Communication Skills (Maintenance)||Change in functional communication skills from 6 weeks to 12 weeks||||||
692418|NCT01429077|Secondary|Western Aphasia Battery Reading and Writing Scores (Maintenance)||Change in WAB Reading and Writing Skills from 6 weeks to 12 weeks||||||
692419|NCT01429077|Secondary|Western Aphasia Battery Aphasia Quotient (Maintenance)||Change in Western Aphasia Battery AQ from 6 weeks to 12 weeks||||||
692420|NCT01429077|Secondary|Western Aphasia Battery - Reading and Writing Scores||Change from Baseline in Western Aphasia Battery Reading and Writing scores at 6 weeks||||||
692421|NCT01429077|Secondary|Participation in Everyday Activities|Measures on CETI, QCL,BOSS, CCRSA.|Change from Baseline in participation in everyday activities at 6 weeks||||||
692422|NCT01429077|Secondary|Functional Communication Skills|Scores derived from language sample analyses|Change from Baseline in functional communication skills at 6 weeks||||||
692423|NCT01429077|Primary|Language Quotient (LQ) on the Western Aphasia Battery|"Includes a measure of auditory comprehension, oral expression, reading and written expression skills.
The scale ranges from 1 - 100 with 100 being better. The change or gain score from baseline to immediately post-treatment (at 6 weeks) is reported. The larger the change score, the greater the improvement."|Change from Baseline in Western Aphasia Battery LQ at 6 weeks|||units on a scale||Standard Deviation|Mean
692424|NCT01429064|Primary|Number of Participants With Adverse Events|Adverse events from start of ODM-201 treatment (in ARADES 3104001 study) until end of study visit (in ARADES-EXT 3104002 study). Median duration on study treatment was 11,0 months.|From first dose of study treatment up to 4 weeks after last dose of study treatment|Safety population||participants|||Number
692425|NCT01429051|Secondary|Number of Participants With Adverse Events (AEs)|The severity (intensity of each AE was assessed as mild (transient symptoms, no interference with daily activities), moderate (marked symptoms, moderate interference with daily activities), or severe (considerable interference with daily activities) by the investigator. Serious adverse events are defined as any untoward medical occurrence that at any dose results in death or is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity or is a congenital anomaly/birth defect. The investigator assessed each AE as either related or not related to study treatment.|12 weeks|Safety analysis set||participants|||Number
692426|NCT01429051|Secondary|Efficacy Phase: General Impression (GI) Score at 60 Minutes After First Dose|"Participants assessed their general impression (GI) of treatment efficacy for treated BTP episodes at 60 minutes after first dose of study drug. The validated, categorical 5-point Verbal Rating Scale (VRS) was used for this assessment and scored as follows:
0 =poor;
1 =fair;
2 =good;
3 =very good;
4 =excellent."|During the efficacy phase (II), at each episode of breakthrough pain, 60 minutes after first dose of study drug.|Efficacy Phase, Full Analysis Set||units on a scale||95% Confidence Interval|Least Squares Mean
692427|NCT01429051|Secondary|Efficacy Phase: Proportion of BTP Episodes With a Positive Response Defined as a ≥ 33% or 50% Reduction in Pain Intensity|"Overall responder rate is defined as the proportion of breakthrough pain (BTP) episodes with a positive response to treatment. The following definitions of a positive response were analyzed: • Greater than 33% reduction in PI from time 0; • Greater than or equal to 50% reduction in PI from time 0. Pain intensity was assessed using the 11-point Numerical Rating Scale (NRS) on a scale from 0 to 10, where 0 represents the absence of pain and 10 is worst possible pain."|During the efficacy phase (II) each episode of breakthrough pain, at 0, 5, 30 and 60 minutes after study drug|Efficacy Phase, Full Analysis Set||proportion of breakthrough pain episodes|Participants||Number
692428|NCT01429051|Secondary|Efficacy Phase: Proportion of BTP Episodes With a Positive Response Defined as a ≥ 1, 2 or 3 Point Reduction in Pain Intensity|"Overall responder rate is defined as the proportion of breakthrough pain (BTP) episodes with a positive response to treatment. The following definitions of a positive response were analyzed: • greater than or equal to 1 point reduction in pain intensity (PI) from time 0, • greater than or equal to 2 point reduction in PI from time 0, and • greater than or equal to 3 point reduction in PI from time 0. Pain intensity was assessed using the 11-point Numerical Rating Scale (NRS) on a scale from 0 to 10, where 0 represents the absence of pain and 10 is worst possible pain."|During the efficacy phase (II) each episode of breakthrough pain, at 0, 5, 30 and 60 minutes after study drug|Efficacy Phase, Full Analysis Set||proportion of breakthrough pain episodes|Participants||Number
692429|NCT01429051|Secondary|Efficacy Phase: Sum of Pain Intensity Differences (SPID0-60 and SPID0-30) Derived From PI Scores|"The SPID30 and SPID60 represent the average improvement in pain intensity over the 30 minute interval and 60 minute interval, respectively. SPIDt was calculated as the area under the curve (AUC) for Pain Intensity Difference over the time interval 0 to t minutes, respectively, divided by the length of the time interval (t minutes). A positive value is a decrease (improvement) of the pain.
Pain intensity was assessed at 0, 5, 30 and 60 minutes after study drug using the 11-point Numerical Rating Scale (NRS) on a scale from 0 to 10, where 0 represents the absence of pain and 10 is worst possible pain. PID is calculated as the difference in pain intensity from time 0 to each time point."|During the efficacy phase (II) each episode of breakthrough pain, at 0, 5, 30 and 60 minutes after study drug|Efficacy Phase, Full Analysis Set||units on a scale||95% Confidence Interval|Least Squares Mean
703384|NCT00094900|Secondary|Mean Change in C-Reactive Protein||12 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||mg/dl||Standard Error|Mean
692430|NCT01429051|Secondary|Efficacy Phase: Pain Intensity Difference (PID) at 5, 30, and 60 Minutes After First Dose of Study Drug|"During the efficacy phase participants assessed their pain intensity at each breakthrough pain (BTP) episode at 0, 5, 30 and 60 minutes after first dose using the 11-point Numerical Rating Scale (NRS) on a scale from 0 to 10, where 0 represents the absence of pain and 10 is worst possible pain. PID is calculated as the difference in pain intensity from time 0 to each time point. A positive value is a decrease (improvement) of the pain; a ≥ 2-point difference is considered as clinically important."|During the efficacy phase (II) each episode of breakthrough pain, at 0, 5, 30 and 60 minutes after study drug.|Efficacy Phase, Full Analysis Set||units on a scale||95% Confidence Interval|Least Squares Mean
692431|NCT01429051|Secondary|Incidence of Improvement or Worsening in Nasal Mucosa Sign or Abnormality Score|Medical examination of the nasal cavity by rhinoscopy was performed by an oto-rhino-laryngologist before the start of study treatment and at 12 weeks. Signs and any abnormalities were observed for each nostril using the following 4 points assessment scale: • 0 =not present; • 1 =present in a mild degree; • 2 =present in a moderate degree; • 3 =present in a severe degree. A difference in score of 1 or more from Baseline to the end of treatment represented a worsening, while a negative value indicated an improvement of the observed clinical sign. The oto-rhino-laryngologist also assessed whether worsening of a sign was related to study drug. Assessments for both left and right nostrils are presented together. The incidence is calculated as the number of assessments (n) in the improvement or worsening category divided by the number of assessments with a non-missing score for the Nasal Mucosa or Abnormality assessment. Only those signs or abnormalities with n>0 were included|Baseline and at 12 weeks|Safety Analysis Set, which included all patients who received at least 1 dose of INFS (including the initial test dose) with non-missing assessments.||proportion of nostril assessments|Participants|95% Confidence Interval|Number
692432|NCT01429051|Primary|Induction Phase: Pain Intensity Difference at 10 Minutes (PID10) After Treatment|"During the efficacy phase participants assessed their pain intensity at each breakthrough pain (BTP) episode at 0 and 10 minutes after first dose using the 11-point Numerical Rating Scale (NRS) on a scale from 0 to 10, where 0 represents the absence of pain and 10 is worst possible pain. PID10 is calculated as the difference in pain intensity from time 0 to 10 minutes. A positive value is a decrease (improvement) of the pain; a ≥ 2-point difference is considered as clinically important."|During the efficacy phase (II), at each episode of breakthrough pain, at 0 and 10 minutes after first dose of study drug.|The Full Analysis Set consisted of all randomly assigned participants who entered the Efficacy Phase (II) of the trial and were treated for at least 1 BTP episode with double-blind INFS in the Efficacy Phase of the trial.||units on a scale||95% Confidence Interval|Least Squares Mean
692433|NCT01428882|Secondary|Rate of Patients and Physician Satisfaction With Sedation|"Endoscopists and patients rated their satisfaction with sedation in a 10-cm visual analogue scale after discharge.The patients were contacted 24–48 h after the procedure to answer a questionnaire regarding if they remembered scope insertion or scope removal and willingness to repeat it with a similar protocol and rated their satisfaction and pain perception from 0 to 10. This phone survey was done by the nurse specifically making the measurements in the endoscopy room, who was blinded to the sedation regimen.
For the interpretation of results of the 0-10 point numerical scale, 0 stands for 'extremely dissatisfied with sedation level during the endoscopic procedure', whereas 10 stands for 'extremely satisfied with sedation level during the endoscopic procedure."|Up to 1 hour after colonoscopy for endoscopists and up to 48 hours for patients|||units on a scale||Full Range|Mean
692434|NCT01428882|Secondary|Rate of Sedation-related Complications During the Procedure and the Recovery Phases|The following events were considered complications of procedural sedation: a decline in oxygen saturation to less than 85 % longer than 30 s after increasing the oxygen flow rate to 5 L/min and transient propofol interruption, a heart rate less than 40 beats per minute and blood pressure less than 80/50 mmHg. Major complications were defined as need for mechanical ventilation or any cardiorespiratory event requiring anaesthesiologist assistance.|Up to two hours, including colonoscopy performance and recovery period|||participants|||Number
692435|NCT01428882|Secondary|Duration of Recovery After the Endoscopic Procedure|"After completion of the procedure, the patient stood in the examination room monitored continuously by a nurse. When patients responded to normal verbal command, they were asked to sit up and were offered a drink. This was considered the early recovery time.
If they were able to stand unassisted by the bed and had stable hemodynamics parameters (saturation>90 % on room air and blood pressure and heart rate within 20 % of baseline), they were transferred to a locker room accompanied by a relative. The discharge criteria included ability to stand unassisted and tolerate clear liquids once dressed. Once a patient met discharge criteria, they were allowed to leave at their own discretion"|Up to 1 hour after colonoscopy|||minutes||Full Range|Mean
692436|NCT01428882|Primary|Level of Sedation Throughout the Entire Procedure|Assessment every two minutes of the level of sedation during the endoscopic procedure, rating it as minimal, moderate or deep.|Up to 1 hour after introduction of the colonoscope|||participants|||Number
692437|NCT01428765|Primary|Concomitant Medication||Baseline|||participants|||Number
692438|NCT01428765|Primary|Medical History||Baseline|||participants|||Number
692439|NCT01428765|Primary|Age Group||Baseline|||participants|||Number
692440|NCT01428765|Primary|Gender||Baseline|||participants|||Number
692441|NCT01428765|Primary|Antithrombotic Treatment Choice at Baseline||Baseline|||participants|||Number
692442|NCT01428765|Primary|HAS-BLED Risk Score|The HAS-BLED score is based on a point system in which 1 point is assigned for hypertension (systolic blood pressure >160 mmHg), 1 point for each of abnormal renal (presence of chronic dialysis or renal transplantation or serum creatinine ≥200 μmol/L) and liver (chronic hepatic disease or biochemical evidence of significant hepatic derangement) function, 1 point each is assigned for stroke, bleeding (previous bleeding history and/or predisposition to bleeding), labile Internation Normalized Ratios (INRs,unstable/high INRs or poor time in therapeutic range), age >65 years and 1 point each for drugs (such as antiplatelet agents, non-steroidal anti-inflammatory drugs) or alcohol.|Baseline|||participants|||Number
692443|NCT01428765|Primary|CHA2DS2-VASc Score|The CHA2DS2-VASc risk score is based on a point system in which 2 points are assigned for a history of stroke or TIA, or age ≥75; and 1 point each is assigned for age 65–74 years, a hypertension, diabetes, cardiac failure, vascular disease and female sex. On the basis of the risk strata defined in previous guidelines, a CHA2DS2-VASc score of 0 corresponds to “low risk”, a score of 1 corresponds to “intermediate risk”, and a score of 2 or more corresponds to “high risk”.|Baseline|||participants|||Number
692444|NCT01428765|Primary|CHADS2 Score|CHADS2 score is based on a point system in which 2 points are assigned for a history of stroke or transient ischemic attack and 1 point each is assigned for age equal to or greater more than 75 years, hypertension, diabetes, or clinical heart failure or impaired left ventricular systolic function (generally interpreted as an ejection fraction ≤ 40%).|Baseline|||participants|||Number
692445|NCT01428713|Primary|To Assess the Efficacy of Oral TA and COCP in Adolescents With Menorrhagia.|"To assess
change in Pictorial Blood Assessment Chart Score (PBAC Score) from baseline to the end of 3 cycles of TA
change in quality of life (QOL) as evaluated by the PedsQL instrument from baseline to the end of 3 cycles of TA
change in Pictorial Blood Assessment Chart Score (PBAC Score) from baseline to the end of 3 cycles of COCP
change in quality of life (QOL) as evaluated by the PedsQL instrument from baseline to the end of 3 cycles of COCP
PBAC score:
Quantitative score to measure menstrual blood loss. Scale range: Minimum - 0 score, Maximum: No maximum Interpretation: Score > 100 indicates heavy menstrual bleeding
Peds QL score:
Score to measure quality of life in children Scale range: Minimum: 0, Maximum 100 Calculation: Subscales are reverse scored (using formula 100 - a x 25) and then all subscales are averaged Eg: Subscale score of 3 is reverse scored as: 100 - (3 x 25) = 25 Interpretation: Higher score indicates better quality of life"|Baseline, 3 cycles|10 patients completed TA and their results were analyzed. 11 patients completed COCP and their results were analyzed.||Scores on a scale||Standard Error|Mean
692446|NCT01428661|Primary|Change From Baseline to Endpoint at Week 8 Using the Total Score of the Hamilton Depression Rating Scale (HAM-D)|Hamilton Rating Scale for Depression (HAM-D) assesses the range of symptoms that are most frequently observed in subjects with major depressive disorder (MDD) on a scale from 0 to 52. Higher HAM-D scores indicate more severe levels of depressive symptoms, thus, a negative change from baseline indicates a reduction (or improvement) in depressive symptoms.|8 weeks|The Intent-to-Treat (ITT) Population included any subject randomized into the study that receives a dose of study medication and that has completed at least one post-baseline efficacy measurement while on study medication.||units on a scale||Standard Error|Mean
692447|NCT01428583|Other Pre-specified|Mean Change From Baseline in Worst Pain Score at Weeks 1, 4, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 12 or Early Termination|The pain intensity scale consisted of 4 questions (pain at its worst in the last 24 hours, pain at its least in the last 24 hours, pain on the average in the last 24 hours and pain right now) each scored on an 11-point numerical rating scale, where 0 = no pain and 10 = pain as bad as you can imagine. “Pain at its worst in the last 24 hours” was reported.|Baseline, Week 1, 4, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 12 or Early Termination|"ITT. Here N (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies those participants who were evaluable at specified time point."||unit on a scale||Standard Deviation|Mean
692448|NCT01428583|Other Pre-specified|Mean Change From Baseline in Average Pain Score at Weeks 1, 4, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 12 or Early Termination|"The pain intensity scale consisted of 4 questions (pain at its worst in the last 24 hours, pain at its least in the last 24 hours, pain on the average in the last 24 hours and pain right now) each scored on an 11-point numerical rating scale, where 0 = no pain and 10 = pain as bad as you can imagine. Pain on average in the last 24 hours was reported."|Baseline, Week 1, 4, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 12 or Early Termination|"ITT. Here N (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies those participants who were evaluable at specified time point."||unit on a scale||Standard Deviation|Mean
692449|NCT01428583|Other Pre-specified|Mean Change From Baseline in Pain Right Now Score at Weeks 1, 4, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 12 or Early Termination|The pain intensity scale consisted of 4 questions (pain at its worst in the last 24 hours, pain at its least in the last 24 hours, pain on the average in the last 24 hours and pain right now) each scored on an 11-point numerical rating scale, where 0 = no pain and 10 = pain as bad as you can imagine. “Pain right now” was reported.|Baseline, Week 1, 4, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 12 or Early Termination (ET)|"ITT. Here N (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies those participants who were evaluable at specified time point."||units on a scale||Standard Deviation|Mean
692450|NCT01428583|Other Pre-specified|Participants Global Assessment of Treatment Satisfaction|"Participant global assessment of treatment satisfaction was scored on a 5-point categorical scale based on response to the question Please rate your overall satisfaction with the study drug you received?” where 1 = very dissatisfied, 2 = dissatisfied, 3 = neither satisfied nor dissatisfied, 4 = satisfied, 5 = very satisfied."|Week 1, 4, Month 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, end of treatment|"ITT. Here N (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies those participants who were evaluable at specified time point."||unit on a scale||Standard Deviation|Mean
692451|NCT01428583|Other Pre-specified|Mean Daily Dose of Immediate-release Oxycodone as Rescue Medication|Immediate-release oxycodone as a single ingredient product was used as a rescue medication only during the first 4 weeks of the treatment period to support the initiation of oxycodone HCl and naltrexone HCl treatment.|Up to Week 4|Data for mean daily dose of immediate-release oxycodone was not reported because as per protocol and analysis plan it was not planned to be summarized.|||||
692452|NCT01428583|Other Pre-specified|Percentage of Participants With Current Opioid Misuse Measure (COMM) Score of 9 or Above|The COMM is a 17-item self-report questionnaire to monitor for aberrant medication-related behaviors among chronic pain participants. Participants are asked to indicate the frequency of individual behaviors on a scale from 0 to 4 (0 = never, 1 = seldom, 2 = sometimes, 3 = often, 4= very often). The total COMM score is the sum of the 17 item scores with a range from 0 to 68. Higher score indicated a higher risk for aberrant medication- related behavior. A score of 9 or higher was defined as high risk for aberrant medication- related behavior.|Baseline, Week 4, Month 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 or early termination|"Safety analysis set included all enrolled participants who had at least 1 dose of oxycodone HCl and naltrexone HCl extended-release capsules. Here n signifies those participants who were evaluable at specified time point."||percentage of participants|||Number
692518|NCT01427920|Primary|Change in HbA1c (Glycosylated Haemoglobin) - PP|Estimated mean change from baseline in HbA1c after 20 Weeks of treatment in per protocol (PP) analysis set.|Week 0, week 20|Per protocol (PP) analysis set - analysis included subjects exposed to BIAsp 30 for more than 12 weeks without any major protocol violations. 24 subjects did not contribute to the statistical analysis after Week 20.||percentage of glycosylated haemoglobin||Standard Error|Least Squares Mean
692453|NCT01428583|Other Pre-specified|Percentage of Participants With Response to Urine Drug Test|Participants with a positive urine drug test for illicit drug substances (marijuana, cocaine, amphetamines, methamphetamines, phencyclidine, and ecstasy), or unexpected drug substances (those other than reported by the participant as therapeutic concomitant medications such as opiates and methadone), or a negative urine test for the expected opioid (oxycodone) was assessed.|Screening, Week 4, Month 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 or early termination|"Safety analysis set. Here N (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies those participants who were evaluable at specified time point."||percentage of participants|||Number
692454|NCT01428583|Other Pre-specified|Number of Participants With Rescue Medication (Acetaminophen Tablets)|Participants had acetaminophen up to 2 grams per day during the treatment period of the study as rescue medication.|Baseline- less than (<) Week 1, Week 1-<4, Week 4-<Month 2, Month 2-<3, Month 3-<4, Month 4-< 5, Month 5-<6, Month 6-<7, Month 7-<8, Month8-<9, Month 9-<10, Month 10-<11, Month 11-<12, Month 12-<End of study (2 weeks post end of Month 12)|"Intent-to-treat (ITT) included all participants in the safety analysis set who had at least 1 pain intensity score reported during treatment. Here n signifies those participants who were evaluable at specified time point."||participants|||Number
692455|NCT01428583|Other Pre-specified|Mean Daily Dose of Study Medication (Oxycodone Component)||Baseline- less than (<) Week 1, Week 1-<4, Week 4-<Month 2, Month 2-<3, Month 3-<4, Month 4-< 5, Month 5-<6, Month 6-<7, Month 7-<8, Month8-<9, Month 9-<10, Month 10-<11, Month 11-<12, Month 12-<End of study (2 weeks post end of Month 12)|"Safety analysis set. Here N (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies those participants who were evaluable at specified time point."||milligram/day||Standard Deviation|Mean
692456|NCT01428583|Other Pre-specified|Duration of Exposure to Study Medication|Duration of exposure to study medication during the course of the study was assessed.|Baseline up to 2 weeks after last dose|Safety analysis set included all enrolled participants who had at least 1 dose of oxycodone HCl and naltrexone HCl extended-release capsules.||days||Full Range|Median
692457|NCT01428583|Other Pre-specified|Time to Stabilization of Study Medication|Stabilization was considered to have occurred when: total daily dose of oxycodone and naltrexone remained unchanged for greater than or equal to (>=) 3 consecutive days, daily acetaminophen used remained at 1 gram or less and immediate-release oxycodone was not being used as a rescue medication. Days to stabilization = date of stabilization - date of first dose + 1.|Baseline up to Month 12|"Safety analysis set included all enrolled participants who had at least 1 dose of oxycodone HCl and naltrexone HCl extended-release capsules. Here N (number of participants analyzed) signifies those participants who were evaluable for this measure."||days||Full Range|Median
692458|NCT01428583|Other Pre-specified|Observed Steady-state Plasma Concentrations (Cobs) of 6-Beta-naltrexol|6-Beta-naltrexol was a metabolite of naltrexone.|Week 1, 4, Month 2, 3, 6, 9, 12 or early termination|Data was not available to report as PK parameters were plotted by individual participant listings but not summarized for analysis, as per planned analysis.|||||
692459|NCT01428583|Other Pre-specified|Observed Steady-state Plasma Concentrations (Cobs) of Naltrexone||Week 1, 4, Month 2, 3, 6, 9, 12 or early termination|Data was not available to report as PK parameters were plotted by individual participant listings but not summarized for analysis, as per planned analysis.|||||
692460|NCT01428583|Other Pre-specified|Observed Steady-state Plasma Concentrations (Cobs) of Noroxycodone|Noroxycodone was a metabolite of Oxycodone.|Week 1, 4, Month 2, 3, 6, 9, 12 or early termination|Data was not available to report as PK parameters were plotted by individual participant listings but not summarized for analysis, as per planned analysis.|||||
692461|NCT01428583|Other Pre-specified|Observed Steady-state Plasma Concentrations (Cobs) of Oxycodone||Week 1, 4, Month 2, 3, 6, 9, 12 or early termination|Data was not available to report as PK parameters were plotted by individual participant listings but not summarized for analysis, as per planned analysis.|||||
692462|NCT01428583|Secondary|Subjective Opiate Withdrawal Scale (SOWS) Score|The presence and level of clinical opiate withdrawal signs or symptoms was determined by participant-reported instrument, subjective opiate withdrawal scale (SOWS). It contains 16 symptoms of opiate withdrawal rated by the participant (anxiety, yawning, sweating, tearing, running nose, goose bumps, shaking, hot flashes, cold flashes, bone or muscle aches, restlessness, nauseous, vomiting, muscle twitch, stomach cramps and feel like using now). Each item is rated on a 5-point scale (0= not at all, 1= a little, 2= moderate, 3= quite a bit, 4= extreme). The total score is the sum of all items, ranging from 0 to 64, higher score indicated severe withdrawal.|Baseline, Week 1, 4, Month 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12|"Safety analysis set included all enrolled participants who had at least 1 dose of oxycodone HCl and naltrexone HCl extended-release capsules. Here n signifies those participants who were evaluable at specified time point."||units on a scale||Standard Deviation|Mean
692463|NCT01428583|Secondary|Percentage of Participants With Clinical Opiate Withdrawal Scale (COWS) Score|The presence and level of clinical opiate withdrawal signs or symptoms was determined by clinician-administered, clinical opiate withdrawal scale (COWS). It contains 11 common opiate withdrawal signs or symptoms rated by clinician (resting pulse rate, gastrointestinal upset, sweating, tremor, restlessness, yawning, pupil size, anxiety or irritability, bone or joint aches, gooseflesh skin, runny nose or tearing), rated on either 3-point, 4-point or 5-point scale, higher score indicated more symptoms of withdrawal. The total score is the sum of all items, ranging from 0 to 48, higher score indicated severe withdrawal. Participants were categorized as less than mild (score 0-4) mild (score 5-12), moderate (score 13-24), moderately severe (score 25-36) or severe (score greater than 36). Percentage of participants with mild (score 5-12), moderate (score 13-24), moderately severe (score 25-36) or severe (score greater than 36) were reported.|Baseline up to Month 12|Safety analysis set included all enrolled participants who had at least 1 dose of oxycodone HCl and naltrexone HCl extended-release capsules.||percentage of participants|||Number
692506|NCT01427933|Other Pre-specified|Number of Participants With Adverse Events (AE) and Participants Who Died|Participants who died or who had clinically significant events defined as serious AEs (SAEs) and other non-serious AEs (regardless of causality). A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.|Baseline up to end of treatment and within 30 days of last dose of study drug (22.6 months)|All randomized participants who received at least 1 dose of study drug and according to the treatment received.||participants|||Number
738608|NCT00450749|Secondary|Serum Concentrations of Total Prostate-specific Antigen (PSA), Free PSA, and Human Kallikrein 2||Baseline and at 4-7 weeks||||||
692464|NCT01428583|Secondary|Number of Participants With Treatment Emergent (TE) Adverse Events (AEs) Based on Intensity|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Intensity of adverse event was defined on the basis of severity of an event and was classified as; mild (does not interfere with participant's usual function), moderate (interferes to some extent with participant’s usual function) and severe (interferes significantly with participant’s usual function). Treatment-emergent are events between first dose of study drug and up to end of study (2 weeks post-end of month 12) that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to end of study (2 weeks post-end of month 12)|Safety analysis set included all enrolled participants who had at least 1 dose of oxycodone HCl and naltrexone HCl extended-release capsules.||participants|||Number
692465|NCT01428583|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Adverse Reactions|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An AE that was attributed to study drug in a participant who received study drug was defined as an adverse reaction. Treatment-emergent are events between first dose of study drug and up to end of study (2 weeks post-end of month 12) that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to end of study (2 weeks post-end of month 12)|Safety analysis set included all enrolled participants who had at least 1 dose of oxycodone HCl and naltrexone HCl extended-release capsules.||participants|||Number
692466|NCT01428336|Secondary|Peak Total Cortisol Values|Peak total cortisol values during cortrosyn stimulation tests(CST)|1 hour for the CST interventions and 2 hour for the ITT interventions|||ug/dl||Full Range|Median
692467|NCT01428336|Secondary|Pearson Correlation of Free Cortisol Values During CSTs With ITT|Correlation of free cortisol levels of 1 ug, 25 ug and 250 ug cortrosyn stimulation test with Insulin Tolerance test is described in the outcome table|1 hour for the CST interventions and 2 hour for the ITT interventions|Correlation of free cortisol levels with 1 ug, 25 ug and 250 ug cortrosyn stimulation test with Insulin Tolerance test is described in the outcome table. The two groups of patients and volunteers were combined to get a full range of values for each intervention.||correlation coefficient||95% Confidence Interval|Number
692468|NCT01428336|Primary|Pearson Correlation of the Total Cortisol Levels Between the ITT and CSTs|Correlation of total cortisol levels of 1 ug, 25 ug and 250 ug cortrosyn stimulation test with Insulin Tolerance test is described in the outcome table|1 hour for the CST interventions and 2 hour for the ITT interventions|Correlation of total cortisol levels with 1 ug, 25 ug and 250 ug cortrosyn stimulation test with Insulin Tolerance test is described in the outcome table. The two groups of patients and volunteers were combined to get a full range of values for each intervention.||correlation coefficient||95% Confidence Interval|Number
692469|NCT01428258|Other Pre-specified|Bone Mineral Density Determined by Dual-energy X-ray Absorptiometry (DXA) Scan|Subjects will have a single DXA test to assess bone mineral density of the lumbar spine and total body during the first dietary treatment that they are randomly assigned to start with.|once during first 3 week dietary treatment||||||
692470|NCT01428258|Secondary|N-terminal Telopeptide (NTX) Plasma Concentration at Day 22|Plasma concentration of NTX was determined as a measure of bone resorption; higher levels indicate greater bone breakdown|day 22 of each dietary treatment|Samples were not obtained from 3 subjects due to a collection error by research staff. Thus the sample size is reduced from 30 to 27.||nmol per liter bone collagen equivalents||Standard Error|Mean
692471|NCT01428258|Secondary|Bone-specific Alkaline Phosphatase (BSAP) Plasma Concentration at Day 22|Plasma concentration of BSAP was determined as a measure of bone turnover.|day 22 of each dietary treatment|Samples were not obtained from 4 subjects due to a collection error by research staff. Thus the sample size is reduced from 30 to 26.||micro gram per liter||Standard Error|Mean
692472|NCT01428258|Secondary|Comparison of Phe Concentrations in Plasma With Concentrations in Dried Blood Spots|Concentrations of Phe in plasma and in dried blood spots collected simultaneously by subjects will be compared using 2 methodologies, regardless of intervention. At each of the 4 study visits (baseline and final for each dietary treatment): 1) venipuncture was used to collect blood and plasma was isolated and analyzed for Phe with ion exchange chromatography and 2) subjects were asked right after the venipuncture to spot their blood on filter paper for analysis of Phe with tandem mass spectroscopy (MS/MS). The discrepancy in Phe concentrations with these 2 methods was compared for each sample pair using Bland-Altman statistical analysis. Each subject should have had 4 sample pairs, 29 x 4 = 116, but we ended up with only 110 sample pairs, as explained below.|4 times total, 2 per treatment|Analysis of sample pairs is required to determine the discrepancy in Phe levels with the 2 methods. Each subject should have had 4 sample pairs, 29 x 4 = 116, but we ended up with only 110 sample pairs. The explanation for the difference is that several subjects did not provide dried blood spots because research staff forgot to obtain them.||micro moles per liter||Standard Error|Mean
692473|NCT01428258|Secondary|Vitamin D (25-OH) Plasma Concentration at Day 22|Vitamin D was measured as a measure of the capacity for calcium absorption. Higher levels of plasma vitamin D are consistent with higher calcium absorption.|day 22 of each dietary treatment|||ng per ml||Standard Error|Mean
692474|NCT01428258|Secondary|Executive Function Assessed by BRIEF|Completion of a standardized test, the Behavior Rating Inventory of Executive Function (BRIEF), by each subject for the GMP diet and the AA diet. Values are T-scores which have a mean of 50 points and a SD of 10 points. A T score of <50 is considered within the normative range. Data are analyzed with a paired t-test.|day 22 of each dietary treatment|||T score||Standard Error|Mean
692475|NCT01428258|Secondary|Dietary Compliance|Compliance with the glycomacropeptide and amino acid dietary treatments will be assessed by comparison of the intake of medical food in grams of protein from medical food per day based on subject completion of 3-day food records prior to the final study visit on day 22. Statistical analysis for a dietary treatment effect will consist of ANOVA.|3 week dietary treatment|||g protein from MF/kg/day||Standard Error|Mean
692517|NCT01427920|Secondary|Change in Fasting Plasma Glucose (FPG) (Central Laboratory Values)|Estimated mean change from baseline in FPG after 20 Weeks of treatment|Week 0, week 20|Full analysis set (FAS) - analysis included endpoint derived after 20 weeks of treatment and missing data was imputed using last observation carried forward (LOCF) where any post-baseline measurements were available. 13 subjects did not contribute to the statistical analysis after Week 20.||mmol/L||Standard Error|Least Squares Mean
738609|NCT00450749|Secondary|Ratio of T:DHT in Prostatic Surgical Tissue||At 4-7 weeks||||||
692476|NCT01428258|Primary|Change in the Plasma Phenylalanine Concentration of PKU Subjects Fed the Glycomacropeptide Diet Compared With the Change When Fed the Amino Acid Diet|Plasma will be collected at each base week and after 3 weeks on each of the dietary treatments, glycomacropeptide and amino acid, following an overnight fast. Plasma phenylalanine concentration (along with the complete profile of free amino acids) will be determined with an amino acid analyzer in the Wisconsin State Lab of Hygiene. Statistical analysis to determine the significance of the change in plasma phe concentration when comparing the 2 diets will consist of ANCOVA with covariates for baseline Phe and dietary Phe intake. The change in plasma Phe concentration from day 22 (final) to day 1 (baseline) was determined after adjusting for baseline Phe level and dietary Phe intake.|baseline to day 22 on each diet|||micro moles per liter plasma||Standard Error|Mean
692477|NCT01428219|Secondary|Time-to-progression.||18 months||||||
692478|NCT01428219|Secondary|Change in Serum PSA With Treatment of Cabozantinib|PSA response.|18 months||09/2017||||
692479|NCT01428219|Secondary|Duration of Response.||18 months||||||
692480|NCT01428219|Secondary|Response Proportion in Both Soft Tissue and Bone Disease.||18 months||||||
692481|NCT01428219|Secondary|Progression-free Survival Time||18 months||09/2017||||
692482|NCT01428219|Secondary|Change in Bone Metabolism Biomarker Expression With Cabozantinib|"Changes in markers of bone metabolism in bone and serum with cabozantinib.
Changes in MET, AKT and VEGFR2 expression and phosphorylation status (activation) in osteoblasts/osteoclasts and prostate cancer cells from bone biopsy specimens with cabozantinib.
Changes in perfusion and diffusion MRI and CT images in bone lesions with cabozantinib and correlate those with response."|18 months||09/2017||||
692483|NCT01428219|Secondary|Incidence of Adverse Events (AEs) Related to Treatment|Toxicity will be analyzed.|18 months||09/2017||||
692484|NCT01428219|Primary|Percentage of Participants Who Remain Progression-free at 12 Weeks|Efficacy will be measured by the proportion of participants who remain progression-free at 12 weeks after initiation of the study. RECIST 1.1 will be used to measure progression. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, or the appearance of one or more new lesions. Kaplan-Meier methods will be used to report progression-free survival.|12 weeks after participant initiates study|||Percentage of participants||95% Confidence Interval|Number
692485|NCT01428128|Secondary|Complete Blood Count (CBC)|Another objective of this trial is to assess if arsenic protects the blood counts that are adversely affected by chemotherapy|Day 9 of chemotherapy||||||
692486|NCT01428128|Primary|Change in p53 Protein Production|A main objective of this trial is to find the dose of arsenic that blocks the activation of p53. Blockage will reduce the amount of p53 production as measured by Western Blot.|Day 1 of chemotherapy|||mg/kg|||Number
692487|NCT01428115|Secondary|Hospital Anxiety and Depression Score (HADS) – Depression Scores by Visit|HADS is used to detect emotional disturbances (such as anxiety and depression) in non-psychiatric patients treated at hospital clinics. It consists of 14 items with 7 items relating to anxiety and to depression respectively. Each item is scored from 0 to 3 therefore scores for each subscale range from 0 to 21 with higher scores indicating higher levels of anxiety and depression. The scores were categorized as follows: 0 to 7 was normal, 8 to 10 was suggestive, and 11 to 21 was case.|Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6]|All data were analyzed as observed and missing values were not replaced by any imputation method.||participants|||Number
692488|NCT01428115|Secondary|Hospital Anxiety and Depression Score (HADS) – Anxiety Scores by Visit|HADS is used to detect emotional disturbances (such as anxiety and depression) in non-psychiatric patients treated at hospital clinics. It consists of 14 items with 7 items relating to anxiety and to depression respectively. Each item is scored from 0 to 3 therefore scores for each subscale range from 0 to 21 with higher scores indicating higher levels of anxiety and depression. The scores were categorized as follows: 0 to 7 was normal, 8 to 10 was suggestive, and 11 to 21 was case.|Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6]|All data were analyzed as observed and missing values were not replaced by any imputation method.||participants|||Number
692489|NCT01428115|Secondary|State Trait Anxiety Index (STAI) Trait Scores by Visit|The STAI questionnaire consists of 40 questions with 20 items allocated to each of the State Anxiety and Trait Anxiety subscales. The scores for each subtest range from 20 to 80, with higher scores indicating higher levels of anxiety.|Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6]|All data were analyzed as observed and missing values were not replaced by any imputation method.||scores on a scale||Standard Deviation|Mean
692490|NCT01428115|Secondary|State Trait Anxiety Index (STAI) State Scores by Visit|The STAI questionnaire consists of 40 questions with 20 items allocated to each of the State Anxiety and Trait Anxiety subscales. The scores for each subtest range from 20 to 80, with higher scores indicating higher levels of anxiety.|Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6]|All data were analyzed as observed and missing values were not replaced by any imputation method.||scores on a scale||Standard Deviation|Mean
692491|NCT01428115|Secondary|Harvey-Bradshaw Index (HBI) Scores by Visit|Harvey-Bradshaw Index (HBI) is for use in the assessment and quantification of symptoms and the present level of disease activity of patients with Crohn’s disease. It is a validated clinical index for Crohn's disease, including the 5 categories of: general well-being, abdominal pain, number of liquid stools, abdominal mass and complications. The score ranges from 0 to 25 with higher scores indicating higher disease activity. The scores were classified as follows: less than 5 is remission, 5 to 7 is mild, 8 to 16 is moderate, and greater than 16 is severe.|Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6]|All data were analyzed as observed and missing values were not replaced by any imputation method.||participants|||Number
692492|NCT01428115|Secondary|Short Inflammatory Bowel Disease Questionnaire (sIBDQ) Scores by Visit|The sIBDQ is a disease-specific health-related quality of life (HRQoL) questionnaire, able to detect and define meaningful clinical changes in inflammatory bowel disease (IBD) patients by measuring physical, social and emotional status. The sIBDQ consists of 10 questions, each question is scored on a scale from 1 (poor QoL) to 7 (good QoL). The scores are summed up and divided by 10 for a mean score ranging from 1 (poor QoL) to 7 (good QoL). A higher score indicates a better HRQoL.|Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6]|All data were analyzed as observed and missing values were not replaced by any imputation method.||scores on a scale||Standard Deviation|Mean
699286|NCT00002540|Secondary|T2 PSA Screening Results|Prostate-Specific Antigen (PSA) result.|T2 (two years after entry)|All males in the Prostate Screening arm who had a PSA screen at T2 were analyzed.||Participants|||Number
692493|NCT01428115|Primary|Change in Hospital Anxiety and Depression Score (HADS) – Depression, From Baseline to After 6 Months of Treatment With Adalimumab|HADS is used to detect emotional disturbances (such as anxiety and depression) in non-psychiatric patients treated at hospital clinics. It consists of 14 items with 7 items relating to anxiety and to depression respectively. Each item is scored from 0 to 3 therefore scores for each subscale range from 0 to 21 with higher scores indicating higher levels of anxiety and depression. The scores were categorized as follows: 0 to 7 was normal, 8 to 10 was suggestive, and 11 to 21 was case.|Baseline and Visit 3 [Month 6]|All data were analyzed as observed and missing values were not replaced by any imputation method. In analyses of changes between visits, only patients with values at both visits were include.||participants|||Number
692494|NCT01428115|Primary|Change in Hospital Anxiety and Depression Score (HADS) – Anxiety, From Baseline to After 6 Months of Treatment With Adalimumab|HADS is used to detect emotional disturbances (such as anxiety and depression) in non-psychiatric patients treated at hospital clinics. It consists of 14 items with 7 items relating to anxiety and to depression respectively. Each item is scored from 0 to 3 therefore scores for each subscale range from 0 to 21 with higher scores indicating higher levels of anxiety and depression. The scores were categorized as follows: 0 to 7 was normal, 8 to 10 was suggestive, and 11 to 21 was case.|Baseline and Visit 3 [Month 6]|All data were analyzed as observed and missing values were not replaced by any imputation method. In analyses of changes between visits, only patients with values at both visits were include.||participants|||Number
692495|NCT01428115|Primary|Change in State Trait Anxiety Index (STAI) Trait Scores From Baseline to After 6 Months of Treatment With Adalimumab|The STAI questionnaire consists of 40 questions with 20 items allocated to each of the State Anxiety and Trait Anxiety subscales. The scores for each subtest range from 20 to 80, with higher scores indicating higher levels of anxiety.|Baseline and Visit 3 [Month 6]|All data were analyzed as observed and missing values were not replaced by any imputation method. In analyses of changes between visits, only patients with values at both visits were include.||scores on a scale||Standard Deviation|Mean
692496|NCT01428115|Primary|Change in State Trait Anxiety Index (STAI) State Scores From Baseline to After 6 Months of Treatment With Adalimumab|The STAI questionnaire consists of 40 questions with 20 items allocated to each of the State Anxiety and Trait Anxiety subscales. The scores for each subtest range from 20 to 80, with higher scores indicating higher levels of anxiety.|Baseline and Visit 3 [Month 6]|All data were analyzed as observed and missing values were not replaced by any imputation method. In analyses of changes between visits, only patients with values at both visits were include.||scores on a scale||Standard Deviation|Mean
692497|NCT01428076|Primary|Weight-adjusted Polidocanol Cmax (Serum)|Cmax measured and adjusted for weight|pharmacokinetics measured- predose, 1, 4, 5, 7, 9, 11, 14, 15, 17, 20, 25, 30 minutes post dose, 1, 2, 3, 4, 5, 6, 8 hours post dose|PK population||ng/mL||Standard Deviation|Mean
692498|NCT01428063|Secondary|Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Who Died During the Study|AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.|For AEs: Day 1 until last visit. For SAEs: Day 1 until 30 days post discontinuation of dosing or participation|The analysis was performed in all treated participants defined as participants who received at least 1 dose of study therapy.||Participants|||Number
692499|NCT01428063|Secondary|Percentage of Participants With Sustained Virologic Response at Post Treatment Week 24 (SVR24)|SVR24 was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected at follow-up week 24.|Week 24 (Follow-up)|The analysis was performed in all treated participants defined as participants who received at least 1 dose of study therapy.||Percentage of participants|||Number
692500|NCT01428063|Secondary|Percentage of Participants With End of the Treatment Response (EOTR)|EOTR was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target not detected at end of treatment.|End of the study (Week 24)|The analysis was performed in all treated participants defined as participants who received at least 1 dose of study therapy.||Percentage of participants|||Number
692501|NCT01428063|Secondary|Percentage of Participants With Complete Early Virologic Response (cEVR)|cEVR was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target not detected at week 12.|Week 12|The analysis was performed in all treated participants defined as participants who received at least 1 dose of study therapy.||Percentage of participants|||Number
692502|NCT01428063|Secondary|Percentage of Participants With Extended Rapid Virologic Response (eRVR)|eRVR was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target not detected at both weeks 4 and 12.|Week 4 and 12|The analysis was performed in all treated participants defined as participants who received at least 1 dose of study therapy.||Percentage of participants|||Number
692503|NCT01428063|Secondary|Percentage of Participants With Rapid Virologic Response (RVR) at Post Treatment Week 4|RVR was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target not detected at Week 4.|Week 4|The analysis was performed in all treated participants defined as participants who received at least 1 dose of study therapy.||Percentage of participants|||Number
692504|NCT01428063|Secondary|Percentage of Participants Other Than Genotype 1 With Sustained Virologic Response at Post Treatment Week 12 (SVR12)|SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected at follow-up Week 12.|Week 12 (Follow-up period)|The analysis was performed in all treated participants who did not exhibit Genotype 1. One subject with indeterminate genotype in the Daclatasvir + Asunaprevir + pegIFN-2a+ Ribavirin Arm/Group was excluded from the analysis||Percentage of participants||95% Confidence Interval|Number
692505|NCT01428063|Primary|Percentage of Participants With Sustained Virologic Response at Week 12 (SVR12) for All Nonresponders With Genotype 1 Hepatitis C Virus (HCV)|SVR12 defined as HCV RNA<limit of quantitation at follow-up Week 12. Nonresponder (NR)=prior NR to pegIFN-2a or ribavirin.|Week 12 (Follow-up period)|Participants with genotype 1 HCV who received at least 1 dose of study drug||Percentage of participants||95% Confidence Interval|Number
692507|NCT01427933|Secondary|Number of Participants With Anti-Ramucirumab Antibodies|The number of participants who developed treatment-emergent antibody responses after baseline. The antibody test can produce positive results in participants without ramucirumab exposure. Treatment emergent anti-ramucirumab antibody positive was defined as: when baseline titer was greater than 0 and post baseline titer was equal to or greater than 4-fold the baseline titer or if the baseline titer was not detected and post baseline titer is equal to or greater than a value of 20.|Day 1 of Cycle 1, Cycle 3, Cycle 5 and 30 days after last dose of study drug up to 17.7 months|All randomized participants who received at least 1 dose of study drug and assessed for treatment emergent antibodies.||participants|||Number
692508|NCT01427933|Secondary|Change in Tumor Size (CTS)|CTS was defines as the change from baseline measurement of target lesions to the post treatment measurement in participants with measurable disease. Change was assessed using radiographic imagining. Log ratio calculated as: log of (tumor size post baseline) divided by (tumor size at baseline). A negative result indicated a shrinking tumor.|Baseline, 6 weeks|All participants with measurable disease at baseline and at 6 weeks.||log ratio||Standard Deviation|Mean
692509|NCT01427933|Secondary|Duration of Response (DOR) Time of Response to Progressive Disease|DOR was measured from the time criteria were met for first objectively recorded CR or PR until first date criteria for PD was met or death. Response defined using RECIST v1.1 criteria. CR defined as disappearance of all lesions and pathological lymph nodes reduction in short axis to <10 mm. PR was defined as ≥30% decrease in sum of diameter (SOD) of target lesions. PD defined ≥20% increase in SOD of target lesion with the sum demonstrating an increase of ≥5 mm; appearance of ≥1 new lesions or unequivocal progression of non-target lesions. Participants who were not known to have died and who did not have PD were censored at the date of the last tumor assessment prior to the date of any subsequent systemic anticancer therapy.|Time from Observed CR or PR to PD up to 12.1 months|ITT population: all participants according to their randomized treatment group and who had CR or PR. Participants censored: Ramucirumab+Eribulin=1, Eribulin=3.||months||95% Confidence Interval|Median
692510|NCT01427933|Secondary|Objective Response Rate (ORR) Percentage of Participants With Measurable Disease Achieving a Best Overall Response of Partial Response (PR) or Complete Response (CR)|ORR was defined as the percentage of participants with measurable disease achieving a best overall response of PR or CR as defined by RECIST v.1.1. CR defined as disappearance of all lesions and pathological lymph nodes reduction in short axis to <10 mm. PR was defined as ≥30% decrease in SOD of target lesions. Participants who did not have any post baseline tumor response assessments for any reason were considered non-responders and included in the denominator when calculating the response rate. ORR for each treatment arm calculated as: [(CR + PR in the treatment arm) divided by (total number of participants in the treatment arm)] x 100.|Start of treatment until documented CR or PR up to 16.5 months|ITT population: all participants according to their randomized treatment group.||percentage of participants||95% Confidence Interval|Number
692511|NCT01427933|Secondary|Overall Survival (OS) Randomization to Date of Death From Any Cause|Time from the date of randomization to the date of death from any cause. For participants who were not known to have died as of the data-inclusion cut-off date, OS data were censored on the last date the participants were known to be alive prior to that cut-off date.|Randomization to date of death from any cause up to 28.6 months|ITT Population: All randomized participants. Participants censored: Ramucirumab and Eribulin=24 , Eribulin Monotherapy=28||Months||95% Confidence Interval|Median
692512|NCT01427933|Primary|Progression‐Free Survival (PFS)|PFS was defined as time from date of randomization until the date of objectively determined progression defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria or death from any cause, whichever is first. Progressive disease (PD) defined as ≥20% increase in sum of diameter (SOD) of target lesion with the sum demonstrating an increase of ≥5 mm; appearance of ≥1 new lesions or unequivocal progression of non-target lesions. Participants with no baseline disease assessment were censored at randomization date, regardless of whether or not objectively determined PD or death was observed; participants not known to have died or to have objective progression as of data inclusion cutoff date were censored at last post baseline radiological assessment date or randomization date, if there was no post baseline radiological assessment.|Start of treatment until documented disease progression or death from any cause up to 16.5 months|Intent-to-treat Population (ITT): all participants according to their randomized treatment group. Participants censored: Ramucirumab+Eribulin=14; Eribulin=17.||months||95% Confidence Interval|Median
692513|NCT01427920|Secondary|Patient Reported Outcomes Evaluated: Treatment-Related Impact Measures for Diabetes (TRIM-D) - Total Score|From the 20 TRIM-D items, an overall score was derived. The scores were transformed to a 0 - 100 scale with higher scores indicating a better health state.|Week 20|Full analysis set (FAS) - analysis included endpoint derived after 20 weeks of treatment and missing data was imputed using last observation carried forward (LOCF) where any post-baseline measurements were available. 17 subjects did not contribute to data.||scores on a scale||Standard Deviation|Mean
692514|NCT01427920|Secondary|Patient Reported Outcomes Evaluated: Treatment-Related Impact Measures for Diabetes (TRIM-D) - Total Score|From the 20 TRIM-D items, an overall score was derived. The scores were transformed to a 0 - 100 scale with higher scores indicating a better health state.|Week 4|Full analysis set (FAS) - analysis included endpoint derived after 20 weeks of treatment and missing data was imputed using last observation carried forward (LOCF) where any post-baseline measurements were available. 20 subjects did not contribute to data.||scores on a scale||Standard Deviation|Mean
692515|NCT01427920|Secondary|Patient Reported Outcomes Evaluated: Treatment-Related Impact Measures for Diabetes (TRIM-D) - Total Score|From the 20 TRIM-D items, an overall score was derived. The scores were transformed to a 0 - 100 scale with higher scores indicating a better health state.|Week 0|Full analysis set (FAS) - analysis included endpoint derived after 20 weeks of treatment and missing data was imputed using last observation carried forward (LOCF) where any post-baseline measurements were available. 10 subjects did not contribute to data.||scores on a scale||Standard Deviation|Mean
692516|NCT01427920|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes|A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of trial product, and no later than one day after product administration. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to week 20|Safety analysis set included all subjects who received at least one dose of BIAsp 30. One subject did not contribute to data.||episodes|||Number
692519|NCT01427920|Primary|Change in HbA1c (Glycosylated Haemoglobin) - FAS|Estimated mean change from baseline in HbA1c after 20 Weeks of treatment in full analysis set (FAS).|Week 0, week 20|Full analysis set (FAS) - analysis included endpoint derived after 20 Weeks of treatment and missing data was imputed using last observation carried forward (LOCF) where any post-baseline measurements were available. 13 subjects did not contribute to the statistical analysis after Week 20.||percentage of glycosylated haemoglobin||Standard Error|Least Squares Mean
692520|NCT01427907|Primary|Serum Phosphorus Levels|The average phosphorus level of non-missing laboratory assessments from the last two weeks of each treatment period for each subject|2 weeks|Modified intent-to-treat: subjects who were randomized, received at least one prescribed dose of the study medication and provided at least one of the last 4 laboratory assessments of each treatment period||mg/dL||Standard Deviation|Mean
692521|NCT01427881|Secondary|Graft Failure|Descriptive statistics will be used to assess the incidence of primary graft failure and secondary graft failure. Primary graft failure is defined as failure to achieve a sustained neutrophil count of >= 500/uL by >= 28 days post-transplant. Secondary graft failure is defined as the decline in neutrophil count to < 500/uL after achieving engraftment which is unrelated to infection or drug effect and is unresponsive to stimulation by growth factors.|By greater than or equal to 28 days post-transplant|||percentage of patients|||Number
692522|NCT01427881|Secondary|Hematologic Recovery|Descriptive statistics will be used to assess the median days of neutrophil and platelet recovery. The day of neutrophil recovery is defined as the first day of three consecutive lab values on different days, after the conditioning regimen-induced nadir of blood counts, that the absolute neutrophil count is > 500/uL. The day of platelet recovery is defined as the first day of three consecutive lab values on different days, after the conditioning regimen-induced nadir of blood counts, that the platelet count is >= 20,000/uL without platelet transfusion support in the seven days prior.|Up to day +100|||days||Full Range|Median
692523|NCT01427881|Secondary|Disease-free Survival|Disease-free survival will be evaluated as Kaplan-Meier estimates.|At 1 year post-transplant|||percentage of patients||95% Confidence Interval|Number
692524|NCT01427881|Secondary|Overall Survival|Overall survival will be evaluated as Kaplan-Meier estimates.|At 1 year post-transplant|||percentage of patients||95% Confidence Interval|Number
692525|NCT01427881|Secondary|Non-relapse Mortality|Defined as death in the absence of recurrent or progressive malignancy after HCT. Non-relapse morality will be assessed with the use of cumulative incidence plots. This secondary endpoint will be characterized and presented as a cumulative incidence.|At 2 years|||percentage of patients||95% Confidence Interval|Number
692526|NCT01427881|Secondary|Persistent or Recurrent Malignancy After HCT|Recurrent or progressive malignancy will be assessed with the use of cumulative incidence plots. Recurrent malignancy will be defined by hematologic criteria. Recurrent malignancy will also be defined as any unplanned medical intervention designed to prevent progression of malignant disease in patients who have molecular, cytogenetic or flow-cytometric evidence of malignant cells after transplantation.|At 2 years|||percentage of patients||95% Confidence Interval|Number
692527|NCT01427881|Secondary|Duration of Systemic Immunosuppressive Treatment|The need for additional immunosuppressive treatment with agents other than those used for prophylaxis, the reasons for their administration (acute GVHD, chronic GVHD, or other reasons) and the duration of its administration will be determined. Patients will be monitored to determine the duration of systemic immunosuppressive treatment. Primary and secondary treatment of acute GVHD and withdrawal of systemic immunosuppressive treatment will be assessed with the use of cumulative incidence plots.|Up to 5 years|This data was not collected.|||||
692528|NCT01427881|Secondary|Grades II-IV and III-IV Acute GVHD|Grades II-IV and III-IV GVHD will be assessed with the use of cumulative incidence plots.|Through day +100 post-transplant|||percentage of patients|||Number
692529|NCT01427881|Secondary|Donor Engraftment|Donor engraftment is defined as the count (percent) of patients with full donor chimerism. Full donor chimerism is defined as at least 95% donor CD3 cells in peripheral blood.|At day 28|||Participants|||Count of Participants
692530|NCT01427881|Primary|Chronic GVHD Requiring Systemic Immunosuppressive Treatment|Chronic GVHD will be defined by National Institutes of Health (NIH) criteria and requiring systemic treatment. A reduction in the cumulative incidence of GVHD from ~35% to ~15% at 1 year would represent a reasonable goal. A sample size of 42 patients provides 90% power to observe such a difference with one-side 5% type-1 error.|At 1 year after transplantation|||percent of patients||95% Confidence Interval|Number
692531|NCT01427803|Secondary|Percentage of Dosing Occasions Where a Dose Was Taken Less Than 22 Hours After the Most Recent Previous Dose|Percentage of dosing occasions where a dose was taken less than 22 hours after the most recent previous dose. 22 hrs was chosen to allow for some imprecision in subjects' recollection|28 days|Participants in Patterns of Use cohort who took the product||Percentage of dosing occasions|Participants||Number
692532|NCT01427803|Secondary|Percentage of Participants Where a Dose Was Taken Less Than 22 Hours After the Most Recent Previous Dose|Percentage of participants where a dose was taken less than 22 hours after the most recent previous dose thus exceeding the label directions. 22 hrs was chosen to allow for some imprecision in subjects' recollection.|28 days|Participants in Patterns of Use cohort who took the product||Percentage of participants|||Number
692533|NCT01427803|Secondary|Percentage of Dosing Occasions Where More Than One Tablet Was Taken|Percentage of dosing occasions where more than one tablet was taken thus exceeding the label directions.|28 days|Participants in Patterns of Use cohort who took the product||Percentage of dosing occasions|Participants||Number
692534|NCT01427803|Secondary|Percentage of Participants With at Least One Dosing Occasion Where More Than One Tablet Was Taken|Percentage of participants with at least one dosing occasion where more than one tablet was taken thus exceeding the label directions.|28 days|Participants in Patterns of Use cohort who took the product||Percentage of participants|||Number
692535|NCT01427803|Secondary|Percentage of Participants Who Took Product With Mean Daily Use >/= 2 Tablets /Use Day|Percentage of participants who took product with mean daily use >/= 2 tablets /use day thus exceeding the label directions on any use day.|28 days|Participants in Patterns of Use User Population who had at least 10 use days of the product||Percentage of participants|||Number
692536|NCT01427803|Secondary|Percentage of Participants Took >/= 2 Tablets/Use Day in Any 10 Use Days|Percentage of participants took >/= 2 tablets/use day in any 10 use days thus exceeding the label directions during a treatment course.|28 days|Participants in Patterns of Use User Population who had at least 10 use days of the product||Percentage of participants|||Number
692537|NCT01427803|Secondary|Estimated Percentage of Misuse for Non-Therapeutic Reasons Using the First 10-Day Treatment Course|This endpoint was an assessment of whether the rate of non-therapeutic misuse exceeded the pre-defined acceptable threshold for non-therapeutic misuse. The difference lay in the estimation of misuse in the Patterns of Use Cohort by using 10-day treatment courses rather than by “use day”. A treatment course for each subject began on the first day they recorded taking one or more tablets which was followed by nine consecutive “evaluable days.”|28 days|Participants in Patterns of Use cohort who took the product + Reasons for misuse interviewed population||Percentage of participants|||Number
692538|NCT01427803|Secondary|Non-therapeutic Reasons for Misuse|Those subjects in the Reasons for Misuse Cohort who did not state misuse due to need for additional pain relief were categorized to Non-therapeutic misuse.|28 days|Participants in Reason for Misuse cohort who misused the product due to non-therapeutic reasons were included in this analysis||Participants|||Number
692539|NCT01427803|Primary|Estimated Percentage of Misuse for Non-Therapeutic Reasons|The primary objective of this trial was to determine the percentage of non-therapeutic misuse. Two aspects of consumer use of Aleve 24 Hour were examined: the frequency at which consumers exceeded the label-defined daily dose modified by those who did so for non-therapeutic reasons.|28 days|Participants in Patterns of Use cohort who took the product + Participants in Reason for Misuse cohort who completed interview||Percentage of Participants|||Number
692540|NCT01427751|Secondary|Percentage of Participants Not Completing the Month 12 Visit Due to Treatment Failure|Treatment failure was defined as withdrawal of the participant from treatment or from the study by the investigator before the final visit because of a lack of efficacy.|12 Months|Intent-to-treat population included all randomized participants.||percentage of participants|||Number
692541|NCT01427751|Secondary|Change From Baseline in National Eye Institute Visual Functioning Questionnaire-25 (VFQ-25)|The VFQ-25 includes 25 vision-targeted questions plus one general health question which assess visual impairment on functioning and specific aspects of health-related quality of life for a total possible composite score of 0 (worst) to 100 (best functionality). A positive change from Baseline indicates improvement.|Baseline, Month 12|Participants from the intent-to-treat population, all randomized participants, with data available for analysis.||score on a scale||Standard Deviation|Mean
692542|NCT01427751|Secondary|Time to BCVA Improvement of 15-or-More Letters|BCVA was measured in the study eye using an eye chart and was recorded as the number of letters read correctly for a total possible score of 0 to 100. The time in days to BCVA improvement of 15-or-More letters.|12 Months|Participants from the intent-to-treat population, all randomized participants, with data available for analysis.||days||Standard Deviation|Mean
692543|NCT01427751|Secondary|Percentage of Patients With a 15-or-More Letter Decrease in BCVA|BCVA was measured in the study eye using an eye chart and was recorded as the number of letters read correctly for a total possible score of 0 to 100. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity).|Baseline, Month 12|Participants from the intent-to-treat population, all randomized participants, with data available for analysis.||percentage of participants|||Number
692544|NCT01427751|Secondary|Percentage of Patients With 15-or-More Letter Improvement in BCVA|BCVA was measured in the study eye using an eye chart and was recorded as the number of letters read correctly for a total possible score of 0 to 100. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). An improvement in the number of letters read means that the vision has improved.|Baseline, Month 12|Participants from the intent-to-treat population, all randomized participants, with data available for analysis.||percentage of participants|||Number
692545|NCT01427751|Secondary|Change From Baseline in Central Retinal Subfield Thickness Using Optical Coherence Tomography (OCT)|Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed in the study eye after pupil dilation at Baseline and Month 12. A negative change from Baseline indicates improvement.|Baseline, Month 12|Participants from the intent-to-treat population, all randomized participants, with data available for analysis.||microns||Standard Deviation|Mean
692546|NCT01427751|Primary|Change From Baseline in Best Corrected Visual Acuity (BCVA)|BCVA was measured in the study eye using an eye chart and was recorded as the number of letters read correctly for a total possible score of 0 to 100. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity) A positive change from Baseline (more letters read correctly) indicates improvement.|Baseline, Month 12|Participants from the intent-to-treat population, all randomized participants, with data available for analysis.||letters||Standard Deviation|Mean
692547|NCT01427738|Secondary|Number of Participants Who Found GV and Nystatin Acceptable.|Acceptability was defined as the willingness to use the drug if it is proven effective to treat oral candidiasis. Participants were asked whether or not they would be willing to use the assigned treatment via questionnaires.|After 14 days of treatment|The analysis for acceptability of treatment was based on 209 subjects.||participants|||Number
692548|NCT01427738|Secondary|Self-Assessment of General Health|Participants rated their general health on two scales. One is a five point scale ranging from 1 to 5 (1=Excellent; 2=Very Good; 3=Good; 4=Fair; 5=Poor)|Weeks 0, 6|N=110 (GV), 110 (Nystatin) wk 0 N= 96 (GV), 95 (Nystatin) wk 6||participants|||Number
692549|NCT01427738|Secondary|Number of Participants Who Were Adherent.|Adherence was reported as a dichotomous variable (adherence vs. non-adherence). Participants who have missing doses less than 15% will be considered as adherent, i.e., if a participant is in the GV arm, then the cutoff point is 28*0.15=4 doses; and for the nystatin arm is 56*0.15=8 doses.|After 14 days of treatment|The analysis for adherence was based on 209 observations.||participants|||Number
692550|NCT01427738|Secondary|Tolerance|The investigators will measure tolerance using a scale from 0 to 3 (0=No side effects experienced, no changes in treatment; 1=Some side effects experienced, but not enough to modify treatment; 2=Some side effects experienced, resulted in treatment interruption; 3=Side effects experienced, resulted in treatment discontinuation.)|After 14 days of treatment|The analysis for tolerance was based on 208 observations.||participants|||Number
692566|NCT01427504|Primary|Boceprevir AUC Pharmacokinetics|Determine boceprevir area-under-the concentration time curve (AUC) when administered alone.|Pre-dose and, 1, 2, 3, 4, 5, 6, and 8 hours post dose on day 11-14|The number of participants was based on the number of subjects that completed all three sequences of medication.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
692551|NCT01427738|Secondary|Quantitative Yeast Colony Counts|If quantitative yeast culture yielding < 20 CFU/mL of Candida spp., then we call this mycological success|At weeks 0, 2, 6|"At entry, 210 observations were available (182 had positive culture result for Candida specimen, and 175 of those had colony count performed) to evaluate quantitative yeast colony counts.
N= 78 (GV), 70 (Nystatin) at end of treatment; N= 51 (GV), 35 (Nystatin) at week 6;"||CFU/mL||Standard Deviation|Mean
692552|NCT01427738|Secondary|Number of Participant With Symptom|Symptoms were assessed using a visual analog scale where the level of discomfort and pain were recorded and quantified using a scoring system from 0 to 3. 0=no discomfort/pain; 1=mild discomfort/pain; 2=Moderate discomfort/pain; 3=Severe discomfort/pain.|after 14 days of treatment|At entry, a total of 217 observations (106 in GV arm; 111 in nystatin arm) were available to evaluate the symptoms (pain and discomfort) associated with OC. At the end of treatment, a total of 204 observations were available to evaluate the symptoms associated with OC using extended Mantel-Haenszel test between GV and nystatin arms.||participants|||Number
692553|NCT01427738|Primary|Number of Participants With Clinical Efficacy|The primary endpoint is clinical efficacy defined as cure (absence of lesions) or improvement (a decrease in severity of lesions) after 14 days of treatment. The oral cavity will be split arbitrarily into 6 sites: left lower and upper labial mucosa and buccal mucosa, right lower and upper labial mucosa and buccal mucosa, hard palate, soft palate, tongue (dorsum, lateral, and ventral), and floor of mouth. Severity is scored using a scoring system from 0 to 3 (0 corresponds to absence of lesions, and 3 corresponds to presence of extensive confluent lesions) which leads to a composite severity score ranging from 0 to 18 after adding up the scores from all 6 sites. Complete success is assigned if the composite score after treatment equals to 0. Improved/partial response is assigned if the composite score after treatment is less than the baseline score. The blinded evaluator scores the severity of lesions by examining different lesion characteristics.|After 14 days of treatment|Out of 221 subjects,17 had oral exams at entry but not week 2: 11 premature discontinuation, 2 missed visits, and 4 without specific reasons. 204 subjects received oral exams at both entry and week 2. 2 more participants were excluded from the final analysis because they had no pseudomem candi at entry, which led to a total of 202 subjects.||participants|||Number
692554|NCT01427517|Primary|Brain GSH|change in brain GSH levels from baseline to post-NAC administration (90 - 110 minutes) in all subjects|Baseline and up to 110 minutes post-NAC administration|||percent increase from baseline||Standard Deviation|Mean
692555|NCT01427504|Primary|Etravirine Cmin Pharmacokinetics Coadministered With Boceprevir|Determine etravirine Cmin when coadministered with boceprevir. [Ratio = etravirine administered with boceprevir / etravirine administered alone]|Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose on day 11-14|The number of participants is based on the number of subjects that completed all three sequences of medication.||Ratio||90% Confidence Interval|Geometric Mean
692556|NCT01427504|Primary|Etravirine Cmax Pharmacokinetics Coadministered With Boceprevir|Determine etravirine Cmax when coadministered with boceprevir. [Ratio = etravirine administered with boceprevir / etravirine administered alone]|Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose on day 11-14|The number of participants is based on the number of subjects that completed all three sequences of medication.||Ratio||90% Confidence Interval|Geometric Mean
692557|NCT01427504|Primary|Etravirine AUC Pharmacokinetics Coadministered With Boceprevir|Determine etravirine AUC when coadministered with boceprevir. [Ratio = Etravirine administered with bocepreivr / etravirine administered alone]|Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours Post-dose on day 11-14|The number of participants is based on the number of subjects that completed all three sequences of medication.||Ratio||90% Confidence Interval|Geometric Mean
692558|NCT01427504|Primary|Boceprevir C8 Pharmacokinetics Coadministered With Etravirine|Determine boceprevir 8 hour concentration when coadministered with etravirine. [Ratio = boceprevir administered with etravirine / boceprevir administered alone]|Pre-dose, 1, 2, 3, 4, 5, 6, and 8 hours post dose on day 11-14|The number of participants is based on the number of subjects that completed all three sequences of medication.||Ratio||90% Confidence Interval|Geometric Mean
692559|NCT01427504|Primary|Boceprevir Cmax Pharmacokinetics Coadministered With Etravirine|Determine boceprevir Cmax when coadministered with etravirine. [Ratio = boceprevir administered with etravirine / boceprevir alone]|Pre-dose and, 1, 2, 3, 4, 5, 6, and 8 hours post dose on day 11-14|The number of participants is based on the number of subjects that completed all three sequences of medication.||Ratio||90% Confidence Interval|Geometric Mean
692560|NCT01427504|Primary|Boceprevir AUC Pharmacokinetics Coadministered With Etravirine|Determine boceprevir AUC when coadministered with etravirine. [Ratio = boceprevir administered with etravirine/ boceprevir alone]|Pre-dose and, 1, 2, 3, 4, 5, 6, and 8 hours post dose on day 11-14|The number of participants is based on the number of subjects that completed all three sequences of medication.||Ratio||90% Confidence Interval|Geometric Mean
692561|NCT01427504|Primary|Etravirine Cmin Pharmacokinetics|Determine etravirine Cmin when administered alone|Pre-dose and, 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post dose on day 11-14|The number of participants is based on the number of subjects that completed all three sequences of medication.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
692562|NCT01427504|Primary|Etravirine Cmax Pharmacokinetics|Determine etravirine Cmax when administered alone|Pre-dose and, 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post dose on day 11-14|The number of participants is based on the number of subjects that completed all three sequences of medication.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
692563|NCT01427504|Primary|Etravirine AUC Pharmacokinetics|Determine etravirine area under the concentration vs. time curve (AUC)when administered alone.|Pre-dose and, 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post dose on day 11-14|The number of participants is based on the number of subjects that completed all three sequences of medication.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
692564|NCT01427504|Primary|Boceprevir C8 Pharmacokinetics|Determine boceprevir 8 hour concentration when administered alone.|Pre-dose and, 1, 2, 3, 4, 5, 6, and 8 hours post dose on day 11-14|The number of participants is based on the number of subjects that completed all three sequences of medication.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
692565|NCT01427504|Primary|Boceprevir Cmax Pharmacokinetics|Determine the Cmax of boceprevir when administered alone.|Pre-dose and, 1, 2, 3, 4, 5, 6, and 8 hours post dose on day 11-14|The number of participants is based on the number of subjects that completed all three sequences of medication.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
738610|NCT00450749|Secondary|Ratio of Testosterone (T) to Dihydrotestosterone (DHT) in Serum||Baseline and at 4-7 weeks||||||
692567|NCT01427309|Other Pre-specified|Safety Overview After Injection With Either Fluzone High Dose or Fluzone Vaccine Through the End of Surveillance Period|All serious adverse events, including deaths and adverse events (AEs) of special interest (Guillain Barre Syndrome, Bell's Palsy, encephalitis/myelitis, optic neuritis, Stevens Johnson Syndrome, and toxic epidermal necrolysis) were collected.|Day 0 up to Day 240 post-vaccination|Safety was assessed in the Full Analysis Set.||Participants|||Number
692568|NCT01427309|Secondary|Occurrences of Culture-confirmed Influenza Caused by Any Influenza Viral Types/Subtypes, in Association With a Respiratory Illness|"Influenza positive cultures were confirmed by using direct immunofluorescence techniques with influenza type–specific (i.e., for Influenza A and Influenza B) antibodies. For culture confirmation of influenza, 3 different culture methods were utilized for each NP sample (Classic Flu A and B culture using Madin Darby Canine Kidney cells, Classic Flu A and B culture using Rhesus Monkey Kidney cells, and R Mix Flu A and B culture).
Respiratory illness is defined as the occurrence of a new onset (or exacerbation of a pre-existing condition/symptom) of one or more of the following symptoms (that persist for or reoccur after a period of at least 12 hours): sneezing, stuffy or runny nose (nasal congestion), sore throat, cough, sputum production, wheezing, or difficulty breathing."|≥14 days post-vaccination|Occurrences of culture-confirmed influenza caused by any influenza viral types/subtypes, in association with a respiratory illness were assessed in the Per-Protocol Analysis Set.||Participants|||Number
692569|NCT01427309|Secondary|Occurrences of Culture-confirmed Influenza Caused by Influenza Viral Types/Subtypes That Are Antigenically Similar to Those Contained in the Vaccine Formulations, in Association With a Respiratory Illness|"Influenza positive cultures were confirmed by using direct immunofluorescence techniques with influenza type–specific antibodies. For culture confirmation of influenza, 3 different culture methods were utilized for each NP sample (Classic Flu A and B culture using Madin Darby Canine Kidney cells, Classic Flu A and B culture using Rhesus Monkey Kidney cells, and R Mix Flu A and B culture). For antigenic similarity determinations, a standard hemagglutination inhibition test using a panel of ferret antisera (ferret antigenicity testing) was used.
Respiratory illness was defined as the occurrence of a new onset (or exacerbation of a pre-existing condition/symptom) of one or more of the following symptoms (that persist for or reoccur after a period of at least 12 hours): sneezing, stuffy or runny nose (nasal congestion), sore throat, cough, sputum production, wheezing, or difficulty breathing."|≥14 days post-vaccination|Occurrences of culture-confirmed influenza caused by influenza viral types/subtypes that are antigenically similar to those contained in the vaccine formulations, in association with a respiratory illness were assessed in the Per-Protocol Analysis Set.||Participants|||Number
692570|NCT01427309|Secondary|Occurrences of Culture-confirmed Influenza Caused by Any Influenza Viral Types/Subtypes, in Association With a Modified CDC-defined Influenza-like Illness|"Influenza positive cultures were confirmed by using direct immunofluorescence techniques with influenza type–specific antibodies. For culture confirmation of influenza, 3 different culture methods were utilized for each NP sample (Classic Flu A and B culture using Madin Darby Canine Kidney cells, Classic Flu A and B culture using Rhesus Monkey Kidney cells, and R Mix Flu A and B culture). For antigenic similarity determinations, a standard hemagglutination inhibition test using a panel of ferret antisera (ferret antigenicity testing) was used.
The modified Centers for Disease Control and Prevention-defined influenza-like illness is the occurrence of fever (defined as temperature > 99.0°F [> 37.2°C]) with cough or sore throat."|≥14 days post-vaccination|Occurrences of culture-confirmed influenza caused by any influenza viral types/subtypes, in association with a modified CDC-defined influenza-like illness were assessed in the Per-Protocol Analysis Set.||Participants|||Number
692571|NCT01427309|Secondary|Occurrences of Culture-confirmed Influenza Caused by Influenza Viral Types/Subtypes That Are Antigenically Similar to Those Contained in the Vaccine Formulations, in Association With a Modified CDC-defined Influenza-like Illness.|"Influenza positive cultures were confirmed by using direct immunofluorescence techniques with influenza type–specific antibodies. For culture confirmation of influenza, 3 different culture methods were utilized for each NP sample (Classic Flu A and B culture using Madin Darby Canine Kidney cells, Classic Flu A and B culture using Rhesus Monkey Kidney cells, and R Mix Flu A and B culture). For antigenic similarity determinations, a standard hemagglutination inhibition test using a panel of ferret antisera (ferret antigenicity testing) was used.
The modified Centers for Disease Control and Prevention-defined influenza-like illness is the occurrence of fever (defined as temperature > 99.0°F [> 37.2°C]) with cough or sore throat."|≥14 days post-vaccination|Occurrences of culture-confirmed influenza caused by influenza viral types/subtypes that are antigenically similar to those contained in the vaccine formulations, in association with a modified CDC-defined influenza-like illness were assessed in the Per-Protocol Analysis Set.||Participants|||Number
692572|NCT01427309|Secondary|Occurrences of Culture-confirmed Influenza Caused by Any Influenza Viral Types/Subtypes, in Association With a Protocol-defined Influenza-like Illness|"For culture confirmation of influenza, 3 different culture methods were utilized for each NP sample (Classic Flu A and B culture using Madin Darby Canine Kidney [MDCK] cells, Classic Flu A and B culture using Rhesus Monkey Kidney [RhMK] cells, and R Mix Flu A and B culture).
A protocol-defined influenza-like illness (ILI) was determined by the occurrence of at least one of the following respiratory symptoms: sore throat, cough, sputum production, wheezing, or difficulty breathing; concurrently with at least one of the following systemic symptoms: fever (defined as temperature > 99.0°F [> 37.2°C]), chills (shivering), tiredness (fatigue), headache, or myalgia (muscle aches)."|≥14 days post-vaccination|Occurrences of culture-confirmed influenza caused by any influenza viral types/subtypes, in association with a protocol-defined influenza-like illness was assessed in the Per-Protocol Analysis Set.||Participants|||Number
692594|NCT01426516|Primary|Efficacy Measured by Change in Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR), Adjusted for Baseline Severity, at 6 Months|"To determine the efficacy of assay-guided treatment (AGT) versus treatment-as-usual (TAU), in terms of depression severity as measured by change in Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR), adjusted for baseline severity, at 6 months
Add:
highest score on any 1 of the 4 sleep items (items 1 to 4)
highest score on any 1 of the 4 weight items (items 6 to 9)
highest score on either of the 2 psychomotor items (15 and 16)
scores for each of the 6 MDD symptom domains
Total scores range from 0-27. 0 = no signs of depression; 27 = severe depression"|6 months|Invalid Data Collection|||||
692595|NCT01426438|Secondary|Change in D-Dimer|Change in D-Dimer from week 0 to week 24|0 and 24 weeks|This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.||ug/ml||Inter-Quartile Range|Median
692573|NCT01427309|Secondary|Occurrences of Culture-confirmed Influenza Caused by Influenza Viral Types/Subtypes That Are Antigenically Similar to Those Contained in the Vaccine Formulations, in Association With a Protocol-defined Influenza-like Illness (ILI)|Influenza positive cultures were confirmed by using direct immunofluorescence techniques with influenza type–specific (i.e., for Influenza A and Influenza B) antibodies. For culture confirmation of influenza, 3 different culture methods were utilized for each NP sample (Classic Flu A and B culture using Madin Darby Canine Kidney [MDCK] cells, Classic Flu A and B culture using Rhesus Monkey Kidney [RhMK] cells, and R Mix Flu A and B culture. For antigenic similarity determinations, a standard hemagglutination inhibition test using a panel of ferret antisera (ferret antigenicity testing) was used.|≥14 days post-vaccination|Clinical efficacy was assessed in subjects who met all eligibility criteria, received the vaccine they were randomized to, had successful surveillance contact, did not received additional influenza vaccinations and did not have protocol deviations likely to impact their responses for the primary and secondary endpoints (Per-protocol analysis set).||Participants|||Number
692574|NCT01427309|Primary|Occurrences of Culture- or Polymerase Chain Reaction (PCR)-Confirmed Influenza Caused by Any Influenza Viral Types/Subtypes, in Association With a Protocol-defined Influenza-like Illness (ILI).|"Influenza positive cultures were confirmed using direct immunofluorescence techniques with influenza type–specific antibodies. 3 culture methods were utilized for each NP sample (Classic Flu A and B culture using Madin Darby Canine Kidney cells, Classic Flu A and B culture using Rhesus Monkey Kidney cells, and R Mix Flu A and B culture). The initial molecular test (PCR) was the validated ProFlu+™ assay by Prodesse, Inc., Waukesha, WI, which had been approved by the Food and Drug Administration through a 510K evaluation for specific detection of Influenza A, B or Respiratory Syncytial Virus.
A protocol-defined influenza-like illness was determined by the occurrence of at least 1 of the following respiratory symptoms: sore throat, cough, sputum production, wheezing, or difficulty breathing; concurrently with at least one of the following systemic symptoms: fever (defined as temperature > 99.0°F [> 37.2°C]), chills (shivering), tiredness (fatigue), headache, or myalgia (muscle aches)."|≥14 days post-vaccination|Clinical efficacy was assessed in subjects who met all eligibility criteria, received the vaccine they were randomized to, had successful surveillance contact, did not received additional influenza vaccinations and did not have protocol deviations likely to impact their responses for the primary and secondary endpoints (Per-protocol analysis set).||Participants|||Number
692575|NCT01426958|Primary|Area Under Curve From 0 to ∞ Hours (AUC0-∞)|AUC0-∞ represents the area under the concentration curve of the analyte in plasma from 0 extrapolated to infinity.|0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post|This subject set includes all evaluable subjects of the treated set who were assigned to the final dose groups and who provide at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
692576|NCT01426958|Primary|Maximum Concentration (Cmax)|Cmax represents the maximum concentration of the analyte in plasma.|0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post|This subject set includes all evaluable subjects of the treated set who were assigned to the final dose groups and who provide at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
692577|NCT01426958|Primary|Area Under Curve From 0 to tz (AUC0-tz)|AUC0-tz represents the area under the concentration curve of the analyte in plasma from 0 to the time of the last quantifiable plasma contentration of the analyte.|0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post|This subject set includes all evaluable subjects of the treated set who were assigned to the final dose groups and who provide at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
692578|NCT01426867|Primary|Mean Ocular Discomfort Score|Ocular discomfort was assessed by the subject immediately following the 8 AM instillation of study drug and rated on a 5-point scale: 0 (none), 1 (mild), 2 (moderate), 3 (severe), and 4 (very severe).|Week 1|Intent-to-Treat (ITT): All subjects who received study medication and had at least 1 scheduled on-therapy visit.||Units on a scale||Standard Deviation|Mean
692579|NCT01426854|Secondary|Proportion of Subjects Who Were Pain-Free at All Postoperative Visits|Ocular pain is defined as a positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching. The Investigator scored ocular pain based on the description of pain by the subject. Pain was scored on a 6-unit scale ranging from 0 (none, absence of positive sensation) to 5 (severe, subject reports intense ocular, periocular or radiating pain requiring prescription analgesic). To be considered pain-free at all post operative visits, the patient must have had a score of 0 at Days 1, 3, 7, and 14 and any unscheduled visit. The proportion of subjects who were pain-free at all post-operative visits is reported as percentage.|Up to Day 14|Intent-to-treat: All randomized subjects who completed cataract/IOL implant surgery and returned for at least one postoperative primary efficacy assessment.||Percentage of subjects|||Number
692580|NCT01426854|Primary|Proportion of Subjects With Clinical Cure at Day 14|Ocular inflammation was assessed by the Investigator during slit lamp examination. Aqueous cells were scored on a 5-unit scale from 0 (none) to 4 (>30 cells), and aqueous flare (protein escaping from dilated vessels) was scored on a 4-unit scale from 0 (no visible flare when compared with the normal eye) to 3 (severe - very dense flare). To be considered cured, the patient must have had a score of 0 for both aqueous cells and aqueous flare. The proportion of subjects with a clinical cure is reported as percentage.|Day 14 postoperative|Intent-to-treat: All randomized subjects who completed cataract/IOL implant surgery and returned for at least one postoperative primary efficacy assessment.||Percentage of subjects|||Number
692596|NCT01426438|Secondary|Change in C-reactive Protein (CRP)|Change in C-reactive protein from week 0 to week 24.|0 and 24 weeks|This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.||ug/ml||Inter-Quartile Range|Median
692597|NCT01426438|Secondary|Change in IL-6|Change in IL-6 from week 0 to week 24|0 and 24 weeks|This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.||pg/ml||Inter-Quartile Range|Median
692598|NCT01426438|Secondary|Change in HOMA-IR|Absolute change from week 0 to week 24 in insulin resistance as estimated by HOMA-IR|0 and 24 weeks|This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.||HOMA IR Score||Inter-Quartile Range|Median
692581|NCT01426789|Secondary|Change From Baseline in DAS28 in Association With the Presence or Absence of HLA-DRB1 *SE (Positive), HLA-DRB1 *401 (Carrier) and HLA-DRB1 Position 11 V/L and in Association With Other Biomarkers|The DAS28 is a measure of disease activity in RA. The score is calculated by a complex mathematical formula, which includes the tender joint count(TJC) and swollen joint count (SJC) out of a total of 28 joints, the high-sensitivity C-reactive protein (hsCRP), and the subject's 'global assessment' of disease activity/general health (GH). The subject's global assessment/GH was indicated by a visual analogue scale of 100 mm where the participant marked a point on a 100 mm line between 0 and 100 (0 indicated very good and 100 indicated very bad). The following formula was used to calculate DAS28: DAS-CRP = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) = 0.36*ln(CRP+1) + 0.014*GH = 0.96. A DAS28-CRP score > 5.1 implies active disease, <3.2 implies controlled disease and <2.6 implied remission. A negative change from baseline indicates improvement.|baseline, 12 weeks|Participants, who completed part 1, were included in the analysis. Statistical analysis was not done on the other biomarkers: osteoprotegerin (OPG), rheumatoid factor (RF), anti-cyclic citrullinated peptide antibodies (CCP) and hsCRP. Therefore, data is provided for the alleles only.||score on a scale||Standard Error|Least Squares Mean
692582|NCT01426789|Secondary|Percentage of Participants Who Achieve ACR50 and ACR70 With the Presence/Absence of the HLA-DRB1*04 Allelic Group|A participant was considered to be a responder according to the ACR50 or ACR70 criteria if the participant had at least 50% or 70% improvement, respectively, in both the tender joint count and swollen joint count measures, and in at least 3 of the following 5 measures: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score, and/or C-reactive protein (CRP)/Erythrocyte Sedimentation Rate (ESR).|12 weeks|Participants, who completed part 1, were included in the analysis.||Percentage of participants|||Number
692583|NCT01426789|Primary|Change From Baseline in Disease Activity Score 28 (DAS28) in Association With the Presence or Absence of HLA-DRB1 04|The DAS28 is a measure of disease activity in RA. The score is calculated by a complex mathematical formula, which includes the tender joint count(TJC) and swollen joint count (SJC) out of a total of 28 joints, the high-sensitivity C-reactive protein (hsCRP), and the subject's 'global assessment' of disease activity/general health (GH). The subject's global assessment/GH was indicated by a visual analogue scale of 100 mm where the participant marked a point on a 100 mm line between 0 and 100 (0 indicated very good and 100 indicated very bad). The following formula was used to calculate DAS28: DAS-CRP = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) = 0.36*ln(CRP+1) + 0.014*GH = 0.96. A DAS28-CRP score > 5.1 implies active disease, <3.2 implies controlled disease and <2.6 implied remission. A negative change from baseline indicates improvement.|baseline, 12 weeks|Participants, who completed part 1, were included in the analysis.||score on a scale||Standard Error|Least Squares Mean
692584|NCT01426789|Primary|Percentage of Participants Who Achieve American College of Rheumatology Response of 20 (ACR20 ) in Association With the Presence or Absence of the HLA-DRB1 *4 Allelic Group|A participant was considered to be a responder according to the ACR20 criteria if the participant had at least 20% improvement in both the tender joint count and swollen joint count measures, and in at least 3 of the following 5 measures: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score, and/or C-reactive protein (CRP)/Erythrocyte Sedimentation Rate (ESR).|12 weeks|Participants, who completed part 1, were included in the analysis.||Percentage of participants|||Number
692585|NCT01426763|Secondary|Number of Subjects With C1 INH Antibodies||Through 30 days after final dose||||||
692586|NCT01426763|Secondary|C1 Inhibitor (C1 INH) and C4 Levels||18 days||||||
692587|NCT01426763|Primary|Incidence and Severity of Adverse Events, Number of Subjects With Local Injection Site Reactions, and Number of Subjects Who Discontinue Study Drug or Withdraw From the Study||18 days|||participants|||Number
692588|NCT01426555|Secondary|Validation of DXA Scanning in Patients With SCI|This study has been designed to evaluate whether sequential DXA scanning of the distal femur and proximal femur is an appropriate clinical tool to monitor bone changes in response to either treatment. Evaluation of bone density by DXA was planned to be compared to CT scans of the distal femur and proximal tibia.|12 months|Dataset unavailable for analysis to VABHS study team. The study was closed by the VABHS IRB.|||||
692589|NCT01426555|Primary|Improvement of Bone Mass as Measured by Sequential Evaluation of Bone Density and Bone Structure|This work was designed to determine if FES-rowing plus Zoledronic acid is superior to FES-rowing alone reversing deterioration and weakening of the bones due to SCI and was planned to confirm the effects of FES-rowing in bone structure in patients not receiving Zoledronic Acid.|12 months|Data was never analyzed because the study was closed by the VABHS IRB. Full dataset is unavailable for analysis.|||||
692590|NCT01426516|Secondary|Acceptability of the Use of AGT for Subjects and Clinicians as Measured by Satisfaction Survey|To determine the acceptability to patients and clinicians of assay-guided treatment (AGT) versus treatment-as-usual (TAU) in outpatient treatment of nonpsychotic major depressive disorder|6 months||||||
692591|NCT01426516|Secondary|Cost|To compare costs of AGT versus TAU in outpatient treatment of nonpsychotic major depressive disorder as measured by claims data.|6 months||||||
692592|NCT01426516|Secondary|Quality of Life as Measured by Self Reported Assessment of Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ)|To determine the efficacy of assay-guided treatment (AGT) versus treatment-as-usual (TAU) in outpatient treatment of nonpsychotic major depressive disorder, in terms of patient quality of life (Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ)) The minimum raw score on the QLESQ is 14, and the maximum score is 70.|baseline, 3, 6 months||||||
692593|NCT01426516|Secondary|Clinician Behavior as Measured by Change in Recorded Treatment Choice Before and After the Assay Results Are Made Available.|Clinicians will rank first and alternative treatment choice and dosage prior to assay and first and two alternative treatment choices after receiving assay results (for AGT group). Clinician choices will be compared.|one week||||||
692599|NCT01426438|Secondary|Change in Large HDL Particles|Change in Large HDL Particles from week 0 to week 24|0 and 24 weeks|This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.||nmol/L||Inter-Quartile Range|Median
692600|NCT01426438|Secondary|Change in Small LDL Particles|Change in Small LDL particles from week 0 to week 24.|0 and 24 weeks|This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.||nmol/L||Inter-Quartile Range|Median
692607|NCT01426438|Secondary|Change in Cholesterol|Absolute change in total cholesterol from week 0 to week 24.|0 and 24 weeks|This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan and had lipid panels at weeks 0 and 24.||mg/dL||Inter-Quartile Range|Median
692608|NCT01426438|Primary|Absolute Change in Relative FMD (%)|The absolute change in maximum relative flow mediated dilation (FMD) (%) of the brachial artery from baseline to week 24.|0 and 24 weeks|This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.||% FMD||Inter-Quartile Range|Median
692609|NCT01426425|Secondary|Chronic Effectiveness (Through 6 Months) of the Freezor Xtra Catheter for the Treatment of AVNRT in Subjects Who Achieved Acute Procedural Success.|If there was no documented evidence of AVNRT recurrence in the post-procedure 6-month follow-up period, the subject is counted as a chronic effectiveness success. The AE Adjudication Committee adjudication of AVNRT recurrence is used to classify subjects for this endpoint.|6 Months|The 378 mITT subjects who had acute procedural success with cryoablation for the treatment of AVNRT are included in this analysis.||Participants|||Count of Participants
692610|NCT01426425|Primary|Chronic Safety (Through 6 Months) of the Freezor Xtra Catheter When Used for the Treatment of AVNRT Using an Endocardial Approach.|Subjects who had at least one safety event during or after their cryoablation procedure or through 6 months of follow-up are considered a primary (chronic) safety failure. A safety event is defined as the occurrence of any adverse event that is adjudicated by the AE Adjudication Committee as being serious and study ablation procedure-related and/or Freezor Xtra Catheter related that: 1) Resulted in death, 2) Resulted in a life-threatening illness or injury, 3) Resulted in permanent impairment of a body function or permanent damage to a body structure, 4) Necessitated significant intervention, such as major surgery or even intravenous medical therapy (e.g., vasopressors), to prevent permanent impairment of a body function or permanent damage to a body structure, or 5) Required in-patient hospitalization or a prolongation of an existing hospital stay.|6 Months|The modified intent-to-treat (mITT) set consists of subjects who signed the ICY-AVNRT consent form and met all Pre-EP and Post-EP study inclusion and no exclusion criteria who had a Freezor Xtra Cardiac Cryoablation Catheter inserted into the vasculature for the purpose of the ICY-AVNRT study.||Participants|||Count of Participants
692611|NCT01426425|Primary|Chronic Effectiveness (Through 6 Months) of the Freezor Xtra Catheter for the Treatment of AVNRT Using an Endocardial Approach.|"Subjects must have met both of the following acute and chronic conditions to be considered a chronic effectiveness (treatment) success:
Acute Success: The inability to induce more than one echo beat by the same pacing maneuvers that induced AVNRT before cryoablation (with drug provocation if required for induction before cryoablation) at the conclusion of the study cryoablation procedure assessment.
Chronic Success: Lack of documented recurrence of clinical AVNRT during the 6-month follow-up period after the study cryoablation procedure."|6 months|The modified intent-to-treat (mITT) set consists of subjects who signed the ICY-AVNRT consent form and met all Pre-EP and Post-EP study inclusion and no exclusion criteria who had a Freezor Xtra Cardiac Cryoablation Catheter inserted into the vasculature for the purpose of the ICY-AVNRT study.||Participants|||Count of Participants
692612|NCT01426373|Secondary|Change From Baseline in Line Drawing Assessment|Each participant was given 2 example line drawings representing each of the 5 submental fat grades (0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme) and asked to select the drawing that best represents their current profile. Improvement is any decrease in grade, and worsening is any increase in grade.|Baseline and month 3 after last treatment|Treatment effect population with available data||participants|||Number
692613|NCT01426373|Secondary|Change From Baseline in Submental Skin Laxity Grade (SMSLG)|"SMSLG assessment was based on clinical evaluation and palpation of the submental area. The SMSLG scale incorporates 3 features: skin wrinkling, adherence to underlying neck structures (bone and muscle) and redundancy (horizontal and vertical folds).
Grade 1 (none): no or minimal superficial wrinkling, skin well apposed to deeper neck structures, no skin redundancy (no skin draping (vertical folds) or skin sagging (horizontal folds));
Grade 2 (mild): mild superficial wrinkling, skin well apposed to deeper neck structures, minimal skin redundancy (slight skin draping and sagging);
Grade 3 (moderate): may have mild to moderate superficial wrinkling, skin has mild to moderate separation from deeper neck structures, moderate skin redundancy (moderate skin draping and skin sagging);
Grade 4 (severe): mild to marked superficial wrinkling, loose skin separated from deeper neck structures, marked skin redundancy (marked skin draping and sagging)."|Baseline and month 3 and month 12 after last treatment|"Treatment effect population with available data (indicated by n)"||units on a scale||Standard Deviation|Mean
692614|NCT01426373|Secondary|Percent Change From Baseline in Submental Fat Thickness|Submental fat thickness was measured using calipers.|Baseline and month 3 and month 12 after last treatment|Treatment effect population with available data at baseline (164) and at each time point||percent change||Standard Deviation|Mean
692615|NCT01426373|Secondary|Response to Subject Global Questions|"Participants answered 3 questions on a 7-point scale that ranged from a great deal worse to a great deal better (questions 1 and 2) or from extremely dissatisfied to extremely satisfied (question 3).
Question 1: Since the start of the study, how would you rate the fat under your chin right now?
Question 2: Since the start of the study, how would you rate the definition between your chin and neck right now?
Question 3: How satisfied are you with the treatment you received in this study?"|Month 3 and month 12 after last treatment|Treatment effect population with available data at each time point||participants|||Number
692616|NCT01426373|Secondary|Mean Change From Baseline in Self-rating of Attractiveness|"Self-rating of Attractiveness assesses aspects of appearance from the participant's perspective with a series of 6 questions: How attractive do you think your overall appearance (chin/neck, eyes, nose, mouth, entire face) is/are? Each question was answered on a scale from 1 to 9 (1 = not at all attractive, 5 = neither attractive nor unattractive, and 9 = extremely attractive). A positive change from baseline indicates improvement."|Baseline and month 3 and month 12 after last treatment|Treatment effect population with available data at baseline (163), month 3 (144), and month 12 (130)||units on a scale||Standard Deviation|Mean
692617|NCT01426373|Secondary|Mean Change From Baseline in Subject Self Rating Scale (SSRS)|The SSRS assesses participants' satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6 (0 = extremely dissatisfied, 1 = dissatisfied, 2 = slightly dissatisfied, 3 = neither satisfied nor dissatisfied, 4 = slightly satisfied, 5 = satisfied and 6 = extremely satisfied). A positive change from baseline indicates improvement.|Baseline and month 3 and month 12 after last treatment|"Treatment effect population with available data (indicated by n)"||units on a scale||Standard Deviation|Mean
692618|NCT01426373|Secondary|Mean Change From Baseline in Patient-Reported Submental Fat Impact Scale (PR-SMFIS)|The PR-SMFIS assesses the impact of submental fat on self-perception of 6 emotional and visual characteristics (unhappy, bothered, self-conscious, embarrassed, look older, and look overweight) related to the appearance of submental fullness as evaluated by the participant. Each item is rated on an 11-point numeric scale from 0 to 10. Scores for the 6 items were averaged to generate a PR-SMFIS total scale score ranging from 0 to 10 where 0 is a positive outcome and 10 is a negative outcome. A negative change from baseline indicates improvement.|Baseline and month 3 and month 12 after last treatment|"Treatment effect population with available data at baseline and each time point (indicated by n)"||units on a scale||Standard Deviation|Mean
692619|NCT01426373|Secondary|Percentage of Participants Who Achieved a Composite 2-grade Response|"A composite 2-grade response is defined as at least a 2-grade improvement from baseline on both the CR-SMFRS and PR-SMFRS.
The CR-SMFRS score is based on the investigator’s clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme).
The PR-SMFRS is based on the participant's response to the question How much fat do you have under your chin right now? and answered on a 5-point ordinal scale (0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat)."|Baseline and month 3 and month 12 after last treatment|"Treatment effect population with available data at baseline and at each time point (indicated by n)"||percentage of participants|||Number
692620|NCT01426373|Secondary|Percentage of Participants Who Achieved a Composite 1-grade Response|"A composite 1-grade response is defined as at least a 1-grade improvement from baseline on both the CR-SMFRS and PR-SMFRS.
The CR-SMFRS score is based on the investigator’s clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme).
The PR-SMFRS is based on the participant's response to the question How much fat do you have under your chin right now? and answered on a 5-point ordinal scale (0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat)."|Baseline and month 3 and month 12 after last treatment|"Treatment effect population with available data at baseline and at each time point (indicated by n)"||percentage of participants|||Number
692621|NCT01426373|Secondary|Mean Change From Baseline in Patient-Reported Submental Fat Scale Rating Scale (PR-SMFRS)|"The PR-SMFRS is based on the participant's response to the question How much fat do you have under your chin right now? and answered on a 5-point ordinal scale (0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat). A negative change from baseline indicates improvement."|Baseline and month 3 and month 12 after last treatment|"Treatment effect population with available data at baseline (163) and at each time point (indicated by n)"||units on a scale||Standard Deviation|Mean
692622|NCT01426373|Secondary|Mean Change From Baseline in Clinician-Reported Submental Fat Rating Scale Scores (CR-SMFRS)|The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme). A negative change from baseline indicates improvement.|Baseline and months 3, 6, 9, and 12 after last treatment|"Treatment effect population (all participants who received at least 1 injection with study drug and had any posttreatment data for treatment effect variables or for the submental skin laxity grade) and with available data at each time point (indicated by n)."||units on a scale||Standard Deviation|Mean
692623|NCT01426373|Primary|Number of Participants With Adverse Events (AEs)|"Serious AEs include any event that met one or more of the following criteria: was fatal or life-threatening, required inpatient hospitalization or prolonged a hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or a significant medical hazard.
The severity of each AE was defined as either:
Mild: The participant was aware of the sign or symptom, but it was easily tolerated.
Moderate: The sign or symptom caused discomfort and interfered with usual activity.
Severe: The sign or symptom was incapacitating, and the participant was unable to engage in usual activity.
The investigator determined the relationship of each AE to the study drug using the question: “Is there a reasonable possibility that the event may have been caused by treatment with the study drug?"|Up to 12 months after last treatment (maximum of 18 months from first treatment)|Safety population||participants|||Number
692624|NCT01426360|Primary|Air Blast Hypersensitivity Score 3 Days After Dentifrice Use|"After 3 days, tooth was isolated. Air was delivered from a standard dental unit air syringe and directed at exposed buccal surface of the hypersensitive tooth for 1 second. The Schiff Cold Air Sensitivity Scale was used to assess the subjects’ response.
0 - Subject does not respond to air stimulus;
- Subject responds to air stimulus, but does not request discontinuation of stimulus;
- Subject responds to air stimulus and requests discontinuation or moves from stimulus;
- Subject responds to air stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus."|3 days after dentifrice use|||scale||Standard Deviation|Mean
692625|NCT01426360|Primary|Tactile Hypersensitivity Score After 3 Days of Dentifrice Use|After 3 days, tactile hypersensitivity assessments were done using an Electronic Force Sensing Probe (Yeaple Probe Model 200A, Xinix Research Inc., USA). Scores were recorded in terms of a quantified, reproducible force applied by a #19 explorer tip. After presetting the probe to 10 grams, the tip of the probe was run across the exposed dentin perpendicular to the examined surface. Subsequent passes were made, each time the applied force was increased by 10 grams, until the subject indicated that he/she was experiencing discomfort, or until the maximum force of 50 grams had been reached.|3 days after dentifrice use|||gram||Standard Deviation|Mean
692626|NCT01426360|Primary|Air Blast Hypersensitivity Scores Immediately After Topical Dentifrice Use|"The tooth was isolated. Air was delivered from a standard dental unit air syringe and directed at the exposed buccal surface of the hypersensitive tooth for 1 second. The Schiff Cold Air Sensitivity Scale was used to assess the subjects’ response.
0 - Subject does not respond to air stimulus;
- Subject responds to air stimulus, but does not request discontinuation of stimulus;
- Subject responds to air stimulus and requests discontinuation or moves from stimulus;
- Subject responds to air stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus."|immediately after dentifrice use|||scale||Standard Deviation|Mean
692714|NCT01425307|Secondary|Non-stroke Neurological Events|This secondary objective will compare standard to alternative treatment for the incidence of non-stroke neurological events. Data for this outcome will be collected through entry and exit neurological exams.|24 months||||||
692627|NCT01426360|Primary|Tactile Hypersensitivity Scores Immediately After Topical Dentifrice Use|Immediately after dentifice use, tactile hypersensitivity assessments were done using an Electronic Force Sensing Probe (Yeaple Probe Model 200A, Xinix Research Inc., USA). Scores were recorded in terms of a quantified force applied by a #19 explorer tip. After presetting the probe to 10 grams, the tip of the probe was run across the exposed dentin perpendicular to the examined surface. Subsequent passes were made, each time the applied force was increased by 10 grams, until the subject indicated that he/she was experiencing discomfort, or until the maximum force of 50 grams had been reached.|immediately after dentifrice use|||gram||Standard Deviation|Mean
692628|NCT01426347|Secondary|Physical Function as Measured by Arthritis Impact Measurement Scales - Short Form (AIMS2 - SF)|In each dimension and component of AIMS2-SF, item scores are from 0 to 10 with 10 being worst health.|Baseline and 16 weeks (end of RCT)|For placebo, analysis is based on 26 at baseline and 33 at the end of RCT For treatment, analysis is based on 27 at baseline and 38 at the end of RCT||units on a scale||Standard Deviation|Mean
692629|NCT01426347|Primary|Disease Activity Score (DAS) 28|"We measured disease activity as measured by DAS 28 at baseline and at the completion of Randomized Controlled trial, both in the placebo and the active treatment group.
We used DAS-28 scores to indicate disease activity. The DAS -28 scale has a minimum of 0 and a maximum of 10, with higher numbers indicating higher disease activity.
We used the following cut-offs: Remission (< 2.6), low disease activity (< 3.2), moderate disease activity (< 5.1) and high disease activity (> 5.1)."|Baseline and 16 weeks (end of Randomized Controlled Trial (RCT))|||composite score||Standard Deviation|Mean
692630|NCT01426269|Other Pre-specified|Period 1: Tolerability (Dryness)|Scaling, dryness, and stinging/burning were graded at baseline and weeks 4, 8, and 12 for subjects taking oral doxycycline and topical metronidazole.|Period 1 (12 Weeks)|||participants|||Number
692631|NCT01426269|Other Pre-specified|Period 1: Tolerability (Stinging/Burning)|Scaling, dryness, and stinging/burning were graded at baseline and weeks 4, 8, and 12 for subjects taking oral doxycycline and topical metronidazole.|Period 1 (12 Weeks)|||participants|||Number
692632|NCT01426269|Other Pre-specified|Period 1: Tolerability (Scaling)|Scaling, dryness, and stinging/burning were graded at baseline and weeks 4, 8, and 12 for subjects taking oral doxycycline and topical metronidazole.|Period 1 (12 Weeks)|||participants|||Number
692633|NCT01426269|Secondary|Period 2: Inflammatory Lesion Count|The evaluator (investigator or a designee) performed lesion counts at each postbaseline visit.|Period 2 (40 Weeks)|||lesions||Standard Deviation|Mean
692634|NCT01426269|Secondary|Period 2: Clinician's Erythema Assessment|The evaluator (investigator) assessed the severity of erythema at baseline and each postbaseline visit using a total erythema score. The erythema of 5 areas of the face (forehead, chin, nose, right cheek, left cheek) was scored using a 5 point Clinician's Erythema Assessment scale (0 = none, 1 = mild, 2 = moderate, 3 = significant, 4 = severe). The total of the 5 individual erythema scores scores was the total erythema score.|Period 2 (40 Weeks)|||units on a scale||Standard Deviation|Mean
692635|NCT01426269|Secondary|Period 2: Investigator's Global Assessment Success|The evaluator (investigator) assessed the severity of rosacea at baseline and each postbaseline visit using a 5 point Investigator's Global Assessment scale. Subjects scores were then dichotomized into success (clear or near clear score) or failure (mild, moderate, or severe score).|Period 2 (40 weeks)|||participants|||Number
692636|NCT01426269|Primary|Period 2: Number of Subjects Who Relapsed|"Subjects who relapsed during phase 2 were discontinued. Relapse was defined as meeting any one of the following criteria:
A return to the baseline lesion count
A return to the baseline IGA score
The investigator determines that a change in rosacea treatment is warranted due to the subject’s clinical condition. The numbers reported here are accumulative numbers for each arm."|Period 2 (40 weeks)|||participants|||Number
692637|NCT01426230|Primary|Change From Baseline to End of Study in LOCF VAS|"Change from baseline in pain score on visual analog scale (VAS) (intensity scored from No Pain (0mm) to Worst Possible Pain (100mm)) at Week 8 of treatment; last observation carried forward (LOCF) analysis"|8 weeks (Baseline and Week 8)|The Number of Participants Analyzed was based on the available VAS.||scores on a scale||95% Confidence Interval|Mean
692638|NCT01426113|Primary|Change From Baseline in Intraocular Pressure (IOP) in the Study Eye|IOP is a measure of the fluid pressure inside the study eye. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive change from baseline indicates an increase in IOP (worsening). Due to lack of enrollment, analysis was not performed for this outcome measure.|Baseline, Week 6|Due to early termination of the study, no statistical analysis was performed and no data summaries were generated. From a target of 120 patients, only 6 patients (3 in each group) were enrolled.|||||
692639|NCT01425879|Secondary|Progression-free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|From start of treatment to time of documented progression or death whichever occurs first, assessed up to 4 weeks after completion of study treatment|||months||95% Confidence Interval|Mean
692640|NCT01425879|Secondary|Overall Survival|Analyzed using Kaplan-Meier method.|From study initiation to time of death, assessed up to 4 weeks after completion of study treatment|||months||95% Confidence Interval|Median
692641|NCT01425879|Secondary|Frequency of Adverse Events Related to MK-2206|Severity of adverse events is graded according to the NCI CTCAE 4.0.|Up to 4 weeks after completion of study treatment, for total treatment time of up to 1 year|||percentage of patients|||Number
692642|NCT01425879|Primary|Overall Response Rate (Complete and Partial Response) as Defined by RECIST 1.1|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 4 weeks after completion of study treatment, for total treatment time of up to 1 year|||patients|||Number
692643|NCT01425853|Secondary|Biomarker Analysis|The following biomarkers will be evaluated: COMP, Coll2-1, Coll2-1 NO2 and Fib3-2|6 months||||||
692644|NCT01425853|Secondary|Number of Adverse Events Defined by Relationship With Treatment|The safety evaluation was done in the set of randomized patients who took at least one dose of the medication|6 months|Safety population||number of events|||Number
692715|NCT01425307|Secondary|Primary Stroke Events|This secondary outcome measure will compare standard to alternative therapy for primary stroke events (a) primary ischemic stroke; b) primary hemorrhagic stroke|24 months||||||
692646|NCT01425853|Secondary|Health Status According to EuroQoL|"EuroQoL-5D was a standardized instrument for use as a measure of health outcome that provides a simple descriptive profile and a single index value for health status. It was assessed at all of the study visits.
The EQ-5D-3L essentially consists of 2 pages - the EQ-5D descriptive system (page 2) and the EQ visual analogue scale (EQ VAS) (page 3). The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. Total scale range for each dimension reported is 1 to 3.
The EQ VAS records the respondent’s self-rated health on a vertical, visual analogue scale where the endpoints are labelled ‘Best imaginable health state’ and ‘Worst imaginable health state’. This information can be used as a quantitative measure of health outcome as judged by the individual respondents.
Total scale range for VAS dimension reported is 0 to 100."|6 months|ADO on PP population||points||Standard Deviation|Mean
692647|NCT01425853|Secondary|Patient’s and Investigator's Global Assessment of Response to Therapy|The investigator were asked to evaluated the patient’s response to therapy of the index knee by marking a (I) a VAS scale with range 0 mm (best) and 100 mm (worst) as follows: Left hand marker “Excellent-Best possible anticipated response, considering the severity and stage of the disease”, right hand marker “None-no response, absence of drug effect”.|6 months|Investigator and Patient's global assessment assessment of response to therapy. ADO on PP population.||units on a scale||Standard Deviation|Mean
692648|NCT01425853|Secondary|Patient’s Global Assessment (PGA) and Investigator's Global Assessment (IGA) of Disease Activity|Patients were asked to quantify their disease status on a VAS scale with range 0 mm (best) and 100 mm (worst) as follows: “Considering all the ways your arthritis of the knee affects you, mark (I) on the scale how well you are doing.” Left hand marker “Very Well”, Right hand marked “Very Poor”.|6 months|Patient and Investigator's global assessment of disease activity. ADO on PP population||units on a scale||Standard Deviation|Mean
692649|NCT01425853|Secondary|Consumption of Rescue Medication|"Use of rescue medication as number of paracetamol tablets 500 mg since the last visit. The tablet count was reconciled with the patient diary.
Total Number of pills per month"|6 months|Consumption of rescue medication (number of daily tablets consumed). ADO on PP population. daily tablets consumed/month||daily tablets consumed/month||Standard Deviation|Mean
692650|NCT01425853|Secondary|Percentage of Presence of Joint Effusion|Study knees were evaluated at each visit for the presence or absence of swelling and/or effusion.|6 months|ADO on PP population||percentage of participants|||Number
692651|NCT01425853|Secondary|Percentage of Presence of Joint Swelling|Study knees were evaluated at each visit for the presence or absence of swelling and/or effusion.|6 months|ADO on PP population||percentage of participants|||Number
692652|NCT01425853|Secondary|Percentage of Participants With Response as Defined by Outcome Variables for Osteoarthritis Clinical Trials - Osteoarthritis Research Society International (OMERACT-OARSI)|"The OARSI Standing Committee for Clinical Trials Response Criteria Initiative and the OMERACT committee, in concert with the international rheumatology community, has led to the development of a uniform core set of outcome measures for OA. One of the objectives was to propose a set of criteria for measurement based on multiple domains to present the results of changes after treatment in symptomatic parameters as a single variable for clinical trials.
To be considered as responder patients should met one the following criteria:
High improvement in pain or in function ≥ 50% and absolute change ≥ 20 or
Improvement in at least 2 of the 3 following:
Pain ≥ 20% and absolute change ≥ 10
Function ≥ 20% and absolute change ≥ 10
Patient’s global assessment ≥ 20% and absolute change ≥ 10"|6 months|ADO on PP population||percentage of participants|||Number
692653|NCT01425853|Secondary|Huskisson’s VAS|Visual Analogue Scale: 0 No Pain 100 Maximum Pain Huskisson’s VAS measures global pain intensity. Patients were asked to quantify their disease status on a 100 mm VAS as follows: “Please indicate the severity of knee pain experienced during the last 48 hours by marking a (I) through the line”. Left hand marker represents “No pain” and right hand marker represents “The worst pain imaginable”.|6 months|ADO on PP population||units on a scale||Standard Deviation|Mean
692654|NCT01425853|Secondary|WOMAC Function Subscale|Western Ontario & McMaster Universities Osteoarthritis Index, from 0 No Function to 1700 Maximum Function WOMAC functional limitation subscale was used to measure the functionality of the knee with pain. Seventeen items are used to assess functionality of the knee: tair use, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy household duties, light household duties.|6 months|||units on a scale||Standard Deviation|Mean
692655|NCT01425853|Secondary|WOMAC Stiffness Subscale|Western Ontario & McMaster Universities Osteoarthritis Index, from 0 No Stiffness to 200 Maximum Stiffness WOMAC stiffness subscale was used to measure the stiffness of the knee with pain. Two items are used to assess stiffness grade: after first waking and later in the day.|6 months|ADO on PP population||units on a scale||Standard Deviation|Mean
692656|NCT01425853|Primary|WOMAC Pain Subscale|Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) Pain subscale Score Range: 0 (no pain) - 500 (maximum pain) The study was designed such that the outcome of primary interest is knee pain related to OA. The measure selected to best evaluate this is an improvement in the WOMAC pain subscales. This subscale consists of 5 items which assesses the pain during walking, using stairs, in bed, sitting or lying, and standing.|6 months|Imputed data on PP population||units on a scale||Standard Deviation|Mean
692657|NCT01425814|Secondary|Absolute Inspiratory Capacity (IC) Values|At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS|Up to Day 2|ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period||Liters||Standard Error|Least Squares Mean
692658|NCT01425814|Secondary|Change From Baseline in Inspiratory Capacity (IC)|Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min) At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS|Up to Day 2|ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period||Liters||Standard Error|Least Squares Mean
692659|NCT01425814|Secondary|Time to Peak Forced Vital Capacity (FVC)|At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected|Day 1|ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period||Hours||Standard Error|Mean
692660|NCT01425814|Secondary|Change From Baseline in Peak Forced Vital Capacity (FVC)|Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min) At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected|Day 1|ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period||Liters||Standard Error|Least Squares Mean
692661|NCT01425814|Secondary|Absolute Forced Vital Capacity (FVC) Values|At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected|Up to Day 2|ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period||Liters||Standard Error|Least Squares Mean
692662|NCT01425814|Secondary|Change From Baseline in Forced Vital Capacity (FVC)|Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min) At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected|Up to Day 2|ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period||Liters||Standard Error|Least Squares Mean
692663|NCT01425814|Secondary|Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve|Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min) At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected|Day 1|ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period||Liters||Standard Error|Least Squares Mean
692664|NCT01425814|Secondary|Change From Baseline in Trough Forced Vital Capacity (FVC)|Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min) Trough at Day 2 was computed as the average of the two values measured at 23 and 24 hours after administration of the morning dose of investigational medicinal product on Day 1 At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected|Day 2|ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period||Liters||Standard Error|Least Squares Mean
692665|NCT01425814|Secondary|Time to Peak Forced Expiratory Volume in One Second (FEV1)|At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected|Day 1|ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period||Hours||Standard Error|Mean
692666|NCT01425814|Secondary|Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1)|Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min) At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected|Day 1|ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period||Liters||Standard Error|Least Squares Mean
692667|NCT01425814|Secondary|Absolute Forced Expiratory Volume in One Second (FEV1) Values|At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected|Up to Day 2|ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period||Liters||Standard Error|Least Squares Mean
692668|NCT01425814|Secondary|Change From Baseline in Forced Expiratory Volume in One Second (FEV1)|Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min) At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected|Up to Day 2|ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period||Liters||Standard Error|Least Squares Mean
692669|NCT01425814|Secondary|Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve|Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min) At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected|Day 1|ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period||Liters||Standard Error|Least Squares Mean
692670|NCT01425814|Primary|Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1)|Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min) Trough at Day 2 was computed as the average of the two values measured at 23 and 24 hours after administration of the morning dose of investigational medicinal product on Day 1 At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected|Day 2|ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period||Liters||Standard Error|Least Squares Mean
692671|NCT01425749|Secondary|A Preliminary Evaluation of Cellular Components of the Injection Site Microenvironment for Cutaneous Immunization With MAGE-A3 ASCI (Activated T Cells, Th1,Th2, Th17 Infiltrating CD4 Cells, Regulatory T Cells, and Myeloid-derived Suppressor Cells).|Cells per mm^2 in the superficial dermis at the vaccine site microenvironment, by enumeration of immunohistochemically stained slides. Biopsies of the vaccine sites were taken at week 1 (1 week after the first vaccine) and week 7 (1 week after the 3rd vaccine). This only was evaluable in Arm B patients.|Over 6 months|Participants enrolled on Arm B who had sufficient biopsy site samples.||cells per mm^2 of dermis||Standard Deviation|Mean
692672|NCT01425749|Secondary|Characterization of the Maturation and Activation of Dendritic Cell (DC) Populations in the Sentinel Immunized Node (SIN) After Treatment With MAGE-A3 ASCI.|Number of CD83+ cells (mature DC) and CD1a+ cells (immature DC/Langerhans cells) per mm^2 in cross-sections of sentinel immunized nodes|Over 3 weeks|Evaluable patients with sufficient node sample for the analysis of DC infiltrates.||cells per mm^2 in SIN||Standard Deviation|Mean
692673|NCT01425749|Secondary|Identification of Antibody Responses to MAGE-A3 After MAGE-A3 ASCI Administration as a Measure of Immunogenicity.|Antibody responses were assessed in serum by ELISA, assay for IgG. Seroconversion was defined as a detectable Ab response by ELISA (>20 EU/ml).|Over 6 months, typically weeks 1, 7, 13, 26|All eligible participants.||percentage of evaluable participantes|||Number
692674|NCT01425749|Secondary|Enumeration of CD4+ and CD8+ T Cells Reactive to MAGE-A3 Epitopes in Peripheral Blood as a Measure of Immunogenicity.|The analysis determined the proportion of CD4+ (and/or CD8+) T cells producing IFN-gamma or TNFα, or both, in response to MAGE-A3 peptide pools (with irrelevant peptide as negative control). T cell response was defined when T cells producing both IFNγ and TNFα in response to MAGE-A3 peptides exceeded (a) twice the maximum of 2 negative controls (PRAME peptides, media only), corrected for pre-existing response; and (b) exceeded the negative controls by at least 0.2% of the T cell population. These criteria also were used to define immunogenicity by ELIspot (IFNγ only). If the negative control values for a given sample were zero, a meaningful fold-increase could not be calculated; so, in those cases, we used the minimum detectable value among all similar assays (0.06%) as the negative control value for that sample.|Over 6 months|All eligible patients with evaluable peripheral blood mononuclear cells; this corresponds to all enrolled patients.||participants|||Number
692675|NCT01425749|Primary|Enumeration of CD4 and CD8 T Cell Responses to MAGE-A3 Epitopes in the Injection Site-draining Lymph Node (Sentinel Immunized Node, SIN) as a Measure of Immunogenicity.|Flow cytometry on in vitro stimulated lymphocytes. A positive immune response was identified as one with bifunctional CD4+ or CD8+ T cells, producing both TNF alpha and IFN-gamma after exposure to antigen.|One week after 3 doses of study drug, on day 22.|Eligible participants with evaluable sentinel immunized node specimens.||participants|||Number
692676|NCT01425749|Primary|Number of Participants With Treatment-related Adverse Events as a Measure of Safety and Tolerability|grade 2 treatment-related adverse events graded by CTCAE v4|Over 6 months|All eligible patients.||participants|||Number
692677|NCT01425632|Secondary|Plasma Concentrations of Unchanged TAU-284 (Bepotastine Besilate) (at a Total of 3 Time Points, i.e., Before and 2 (±1) Hours After Study-drug Administration at Week 1 and Before Study-drug Administration at Week 2)||Week 2||||||
692678|NCT01425632|Secondary|Adverse Events and Adverse Drug Reactions||Week 2||||||
692679|NCT01425632|Secondary|Change From Baseline in Severity Score||Week 2||||||
692680|NCT01425632|Secondary|Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings)||Week 2||||||
692681|NCT01425632|Secondary|Change From Baseline in Individual Nasal Symptom Scores (Sneezing, Rhinorrhea, Nasal Congestion, and Impairment in Daily Activities)||Week 2||||||
692682|NCT01425632|Secondary|Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion]||Week 2||||||
692683|NCT01425632|Primary|Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] (at Final Evaluation)|Total score for the three major nasal symptoms (sneezing, rhinorrhea, and nasal congestion) were rated on 4-point scale ranging from 0 (no symptoms) to 3 (severe) .|Baseline and Week 2|||units on a scale||Standard Error|Least Squares Mean
692684|NCT01425528|Secondary|Pittsburgh Sleep Quality Index||Baseline, 8 wks, 12 wks, 24 wks (optional)||||||
692685|NCT01425528|Secondary|Brief Symptom Inventory||Baseline, 8 wks, 12 wks, 24 wks (optional)||||||
692686|NCT01425528|Secondary|Beck Depression Inventory||Baseline, 8 wks, 12 wks, 24 wks (optional)||||||
692687|NCT01425528|Secondary|Behavior Rating Inventory of Executive Function (BRIEF) Adult Version||Baseline, 8 wks, 12 wks, 24 wks (optional)||||||
692688|NCT01425528|Secondary|Hamilton Depression Rating Scale||Baseline, 8 wks, 12 wks, 24 wks (optional)||||||
692689|NCT01425528|Secondary|Hamilton Anxiety Rating Scale||Baseline, 8 wks, 12 wks, 24 wks (optional)||||||
692690|NCT01425528|Primary|Change in Neurotransmitter Metabolite Levels in Cerebral Spinal Fluid||Baseline, 8 wks, 12 wks||||||
692691|NCT01425528|Primary|Change in BH4 Levels in Cerebral Spinal Fluid|Identify dosing range of oral Kuvan® necessary and sufficient to normalize CSF BH4 levels in adults with GTPCH Deficiency.|Baseline, 8 wks, 12 wks|Data from 4 of 6 participants was analyzed for Kuvan Cohort 1 and for Kuvan Cohort 2 for this outcome measure. 2 participant withdrew, 1 participant's diagnosis was reclassified and we were unable to obtain baseline CSF on 1 participant.||nmol/L||Standard Deviation|Mean
692744|NCT01424813|Other Pre-specified|Percent of Rescue Medication Free Days in the Patient Diary||Treatment days 1 through 85||||||
692745|NCT01424813|Other Pre-specified|Percent of Symptom Free Days on the Patient Diary||Treatment days 1 through 85||||||
692692|NCT01425463|Secondary|Percentage of Responders at Week 12|Responders are defined as having an increment of Hemoglobin (Hb) > 15 g/L and post-treatment Hb > 120 g/L (male) or > 110 g/L (female) at Visit 6 (Week 12).|End of Treatment Period (Week 12)|The Analysis Population refers to the Per-Protocol Set (PPS), which is defined as a subset of the FAS, excluding all subjects with protocol deviations considered important for the subjects’ validity concerning the efficacy analysis.||percentage of participants|||Number
692693|NCT01425463|Secondary|Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 8||From Baseline to Week 8|The Analysis Population refers to the Per-Protocol Set (PPS), which is defined as a subset of the FAS, excluding all subjects with protocol deviations considered important for the subjects’ validity concerning the efficacy analysis.||gramm per liter (g/L)||Standard Deviation|Mean
692694|NCT01425463|Secondary|Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 4||From Baseline to Week 4|The Analysis Population refers to the Per-Protocol Set (PPS), which is defined as a subset of the FAS, excluding all subjects with protocol deviations considered important for the subjects’ validity concerning the efficacy analysis.||gramm per liter (g/L)||Standard Deviation|Mean
692695|NCT01425463|Secondary|Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 2||From Baseline to Week 2|The Analysis Population refers to the Per-Protocol Set (PPS), which is defined as a subset of the FAS, excluding all subjects with protocol deviations considered important for the subjects’ validity concerning the efficacy analysis.||gramm per liter (g/L)||Standard Deviation|Mean
692696|NCT01425463|Primary|Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 12||From Baseline to Week 12|The Analysis Population refers to the Per-Protocol Set (PPS), which is defined as a subset of the FAS, excluding all subjects with protocol deviations considered important for the subjects’ validity concerning the efficacy analysis.||gramm per liter (g/L)||Standard Deviation|Mean
692697|NCT01425359|Secondary|Patient's Global Impression of Change (PGIC) Scale Score|The PGIC was completed at the end of treatment/last visit.The PGIC scale measures the change in the participant's overall status since the beginning of the study on a scale ranging from 1 (no change or worse) to 7 (very much improved).|8 weeks|Participants in the Full Analysis Set with available data were analyzed.||units on a scale||Standard Error|Mean
692698|NCT01425359|Secondary|Change From Baseline in the Short-Form 36® (SF-36) Mental and Physical Component Scores|The range of each health domain score is 0-100, with 0 indicating a poorer health state and 100 indicating a better health state. An increase in score indicates an improvement in health state. Participants were asked to complete the survey at randomization (prior to receiving treatment), and at end of treatment visit (Week 8) or early study drug discontinuation or early termination visit. The survey asked participants for responses specific to the preceding 4 weeks prior to completing the survey.|Up to 8 weeks|Participants in the Full Analysis Set with available data were analyzed.||units on a scale||Standard Error|Mean
692699|NCT01425359|Secondary|Percentage of the Last 6 Weeks on Treatment During Which the Angina Frequency Was ≤ 50% of the Baseline Average Weekly Angina Frequency||6 weeks|Full Analysis Set||percentage of weeks||Standard Error|Mean
692700|NCT01425359|Secondary|Percentage of Weeks Participants Achieved at Least a 50% Reduction in Angina Frequency|For each participant, the percentage of the last 6 weeks on treatment during which the angina frequency was less than or equal to 50% of the baseline average weekly angina frequency was determined.|6 weeks|Participants in the Full Analysis Set with available data were analyzed.||percentage of weeks||Standard Deviation|Mean
692701|NCT01425359|Secondary|Average Weekly Frequency of Sublingual Nitroglycerin Use Over the Last 6 Weeks of Treatment|Average weekly frequency of sublingual nitroglycerin use was defined as the total number reported during the last 6 weeks of treatment divided by the duration corresponding to the last 6 weeks of treatment.|6 weeks|Full Analysis Set||nitroglycerin uses per week||Standard Deviation|Mean
692702|NCT01425359|Primary|Average Weekly Angina Frequency Over the Last 6 Weeks of Treatment|"Average weekly angina frequency was defined as the total number of angina episodes reported during the last 6 weeks of treatment divided by 6 weeks.
For subjects who terminated with less than 6 weeks of treatment, frequency was calculated as the total number of angina episodes reported during the treatment period divided by the subject’s actual duration of treatment."|6 weeks|Full Analysis Set (FAS): randomized participants who received at least 1 dose of randomized study drug with at least 1 postbaseline primary efficacy measurement and did not have any major eligibility violations. Participants were included in the FAS if they did not discontinue study drug prior to Day 14.||angina attacks per week||Standard Deviation|Mean
692703|NCT01425307|Secondary|Change of Baseline in Hepatic Iron Overload as Assessed by Liver Iron Concentration|This secondary objective will compare standard to alternative therapy for hepatic iron overload.|Baseline and 24 months|Participants with available data||mg FE per g dry weight liver||Standard Deviation|Mean
692704|NCT01425307|Secondary|Number of Participants With Serious Adverse Events||24 Months||||||
692705|NCT01425307|Secondary|Number of Participants With Liver MRI Complications|This outcome will be recorded through questions asking whether there have been Liver MRI complications at baseline, middle, and end of treatment. Any complication higher than a CTCAE grade 2 event will be reported as a SAE.|24 months||||||
692706|NCT01425307|Secondary|Number of Participants With Phlebotomy Complications|This outcome will be recorded on every interval visit form through questions asking whether there have been phlebotomy complications. Any complication higher than a CTCAE grade 2 event will be reported as a SAE.|24 months||||||
692707|NCT01425307|Secondary|Number of Participants With Hydroxyurea Toxicities|This measure will be performed on a monthly basis throughout the trial by recording the CBC and retic count.|24 Months||||||
692708|NCT01425307|Secondary|Number of Participants With Transfusion Events|This outcome will be recorded on every interval visit form through questions asking whether there have been transfusion complications. Any complication higher than a CTCAE grade 2 event will be reported as a SAE.|24 months||||||
692709|NCT01425307|Secondary|Growth and Development|This outcome will be measured by capturing height and weight monthly and conducting an annual pubertal assessment.|24 months||||||
692710|NCT01425307|Secondary|Neuropsychological Decline|This outcome will be measured using standardized neurocognitive tests at baseline and exit.|24 months||||||
692711|NCT01425307|Secondary|Functional Status|This outcome will be measured using Barthel Index testing at the beginning, middle, and end of the treatment period.|24 months||||||
692716|NCT01425307|Secondary|TCD Time-averaged Mean Velocity on the Non-index Side|This secondary endpoint for the TWiTCH trial will be maximum TCD time-averaged mean velocity on the non-index side. The non-index side is the side with the lower mean (averaged over baseline evaluations) of the maximum (over arteries on that side) TCD time-averaged velocity. Values of the secondary endpoint will be obtained at clinic visits during baseline and during the 24-month treatment period.|24 months||||||
692717|NCT01425307|Primary|Difference in TCD Time-averaged Mean Velocity (TAMV) on the Index Side|The primary endpoint for the TWiTCH trial was the difference between the treatment groups of the maximum TCD TAMV on the index side, calculated from a mixed model. The index side is the side with the higher mean (averaged over baseline evaluations) of the maximum (over arteries on that side) TCD time-averaged velocity. Values of the TAMV on the index site were obtained at clinic visits during baseline and during the treatment period.|Since the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 24 Months).|Intention-to-Treat||cm/sec||95% Confidence Interval|Mean
692718|NCT01425268|Secondary|Expansion Days|The median number of days taken to complete the expansion process.|12 months|All breasts successfully exchange from expander to standard breast implant were analyzed for the length of time to complete the expansion process (days)||days|breasts|Full Range|Median
692719|NCT01425268|Primary|Successful Tissue Expansion and Exchange to a Permanent Breast Implant Unless Precluded by a Non-device Related Event|The primary endpoint is assessed when the subject has completed tissue expansion and completed an exchange to standard breast implants. Subjects not completing the exchange procedure due to a device related event are considered failures.|12 months|Primary Analysis Population (Per Protocol Cohort) = Subjects with an expander implanted successfully with no major protocol violation (evaluated per breast). Subjects who had a bilateral procedure have each breast evaluated separately.||Breasts|Breasts||Count of Units
692720|NCT01425229|Primary|Cmax|Cmax after the first dose of bosentan, at steady-state, during clarithromycin|after first dose, at steady-state, during clarithromycin|||ng/ml||95% Confidence Interval|Geometric Mean
692721|NCT01425229|Primary|AUC|AUC of bosentan after first-dose, at steady-state and during clarithromycin therapy|0-infinity; dosing interval|||h*ng/ml||95% Confidence Interval|Geometric Mean
692722|NCT01425203|Secondary|Percentage of Participants Achieving Early Virologic Response (EVR) At Treatment Week (TW) 8|EVR was defined as an undetectable HCV-RNA level at TW 8. This analysis was conducted when all participants had completed 8 weeks of the study or had discontinued prior to TW 8.|Treatment Week 8|Full Analysis Set (FAS); all randomized participants who received at least 1 dose of any trial medication (PEG, RBV, or BOC) in the Treatment Phase. The Crossover arm had zero participants at TW8 since the first opportunity for participants in the PBO + PR Control arm to roll over to the Crossover arm was at TW12.||percentage of participants|||Number
692723|NCT01425203|Secondary|Percentage of Participants Achieving SVR24 Among Participants Who Received At Least One Dose of Experimental Trial Drug (Modified Intent-To-Treat [mITT] Population)|SVR24 was defined as an undetectable plasma HCV-RNA level at FW24. If a participant was missing FW24 data and had undetectable HCV-RNA at FW12, the participant was considered a sustained virologic responder.|Follow-up Week 24 (up to 72 weeks)|mITT population included all randomized participants who received ≥1 dose of experimental trial drug: BOC (for Experimental RGT BOC + PR arm) or Placebo (for PBO + PR Control arm). Participants in the PBO Control Arm who switched to the Crossover Arm were considered failures for SVR24 in this analysis and are not reported here.||percentage of participants|||Number
692724|NCT01425203|Primary|Percentage of Participants Achieving Sustained Virologic Response At Follow-up Week 24 (SVR24) Among Participants Who Received At Least One Dose of Any Trial Medication (Full Analysis Set Population)|SVR24 was defined as an undetectable plasma Hepatitis C Virus-ribonucleic acid (HCV-RNA) level at Follow-up Week 24 (FW24). If a participant was missing FW24 data and had undetectable HCV-RNA at FW12, the participant was considered a sustained virologic responder.|Follow-up Week 24 (up to 72 weeks)|Full Analysis Set (FAS); all randomized participants who received at least 1 dose of any trial medication (PEG, RBV, or BOC) in the Treatment Phase. Participants in the PBO Control Arm who switched to the Crossover Arm were considered failures for SVR24 in this analysis and are not reported here.||percentage of participants|||Number
692725|NCT01425190|Primary|Final Dose of Boceprevir By Age Group||Day 1|This outcome measure could not be analyzed due to termination of the study prior to enrolling Cohorts 2 and 3.|||||
692726|NCT01425190|Primary|Time of Maximum Plasma Concentration (Tmax) of Single Dose Boceprevir|The time at which the maximum plasma boceprevir concentration was observed.|0 (pre-dose), 0.5, 1, 2, 2.5, 4.5, 5.5, 8, and 10 hours post dose|The Per Protocol (PP) population includes all participants who complied with the protocol sufficiently to ensure that data for this assessment were likely to exhibit the effects of treatment, according to the underlying scientific model.||Hour||Full Range|Mean
692727|NCT01425190|Primary|Maximum Plasma Concentration (Cmax) of Single Dose Boceprevir|The maximum observed plasma concentration of boceprevir across sampling intervals was determined.|0 (pre-dose), 0.5, 1, 2, 2.5, 4.5, 5.5, 8, and 10 hours post dose|The Per Protocol (PP) population includes all participants who complied with the protocol sufficiently to ensure that data for this assessment were likely to exhibit the effects of treatment, according to the underlying scientific model.||ng/mL||Full Range|Mean
692728|NCT01425190|Primary|Area Under the Plasma Concentration Time Curve (AUC) From 0-Infinity of Single Dose Boceprevir|Plasma concentrations of boceprevir were determined at 0 (pre-dose), 0.5, 1, 2, 2.5, 4.5, 5.5, 8, and 10 hours post dose.|0 (pre-dose), 0.5, 1, 2, 2.5, 4.5, 5.5, 8, and 10 hours post dose|The Per Protocol (PP) population includes all participants who complied with the protocol sufficiently to ensure that data for this assessment were likely to exhibit the effects of treatment, according to the underlying scientific model.||ng hr/mL||Full Range|Mean
692729|NCT01424943|Secondary|Parent Symptoms of Depression, Anxiety and Stress|DASS-21, brief screening measure of symptoms of depression, anxiety, and stress. Scores on each scale range from 0-21. Higher scores indicate more symptoms in each area.|baseline, 5 months|||scores on a scale||Standard Deviation|Mean
692730|NCT01424943|Primary|KIPS|KIPS observational measure of the quality of the parent-child relationship. scores range from 1-5. Higher scores indicate a higher quality of relationship.|Baseline, 5 months|||scores on a scale||Standard Deviation|Mean
693448|NCT01414413|Secondary|Loss to Retention|Comparison between study arms of the proportion of participants who initiate ART during the first 6-months of the HIV-testing intervention who are lost to retention within 6 months after initiating ART 6-months|The first 6-months following availability of home-based HIV testing|||participants|||Number
692731|NCT01424943|Primary|Parenting Self-confidence|Toddler Care Questionnaire. Measures parent reported self-confidence in parenting a toddler. Parents rate their confidence in performing parenting tasks specific to toddlers. Higher scores indicate more confidence. Scores range from 37-185. The total sum score derived from adding the scores for the 37 items in this survey was used for this outcome measure.|Baseline, 5 months|||units on a scale||Standard Deviation|Mean
692732|NCT01424943|Primary|Child Behavior|Child Behavior Checklist 1/5-5. A parent report measure of child behavioral problems. The score used for this outcome was the CBCL Total Score, which is a T-Score. T scores average 50 with a standard deviation of 10. Scores above 65 considered in the clinical range.|Baseline, 5 months|||T-score||Standard Deviation|Mean
692733|NCT01424943|Primary|Parenting Style|Parenting Scale (Total Score; measure of parenting style). 30 items on the scale, scores range from 1-7 for each item with higher scores indicating dysfunctional parenting styles (laxness, over-reactivity, hostility). Scores summed and divided by 30 for total score.|Baseline, 5 months|||scores on a scale||Standard Deviation|Mean
692734|NCT01424930|Secondary|Area Under the Plasma Concentration-time Curve From the Time of Administration to 24 Hours After Dosing (AUC24h)|The table below shows mean AUC24h. The Area Under the Plasma Concentration-Time Curve (AUC) is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption.|Day 7 and Day 14|Participants who received at least 1 dose of study medication and were included in the pharmacokinetics analysis.||ng*h/mL||Standard Deviation|Geometric Mean
692735|NCT01424930|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Abiraterone|The table below shows median Tmax of Abiraterone. The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.|Day 7 and Day 14|Participants who received at least 1 dose of study medication and were included in the pharmacokinetics analysis.||hours||Full Range|Median
692736|NCT01424930|Secondary|Maximum Observed Plasma Concentration (Cmax) of Abiraterone|The table below shows mean Cmax of Abiraterone. The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration.|Day 7 and Day 14|Participants who received at least 1 dose of study medication and were included in the pharmacokinetics analysis.||ng/mL||Standard Deviation|Geometric Mean
692737|NCT01424930|Primary|Number of Participants With Grade 3 or Higher Adverse Events (AEs) of Special Interest or Grade 3 or Higher Serious AEs Due to Study Medication|AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Events with Grade 3 or higher (3=Severe; 4=life-threatening; 5=fatal) are events that significantly interrupt usual daily activity, require systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable events.|Postdose on Cycle 1 Day 8 to predose on Cycle 2 Day 1|Safety population: Participants who received at least 1 dose of study medication and contributed any safety data after the start of study treatment.||Participants|||Number
692738|NCT01424813|Other Pre-specified|Morning Peak Expiratory Flow Reading Reported on Patient Diary||Treatment days 1 through 85||||||
692739|NCT01424813|Secondary|Participants With Clinically Significant Vital Sign Assessments|"For both standard and serial vital signs, participants were seated for at least 5 minutes before vital signs were assessed. Heart rate was obtained prior to the blood pressure measurement. Serial heart rate and blood pressure were conducted in the sitting position prior to the spirometry assessment; baseline measures were taken pre-dose at -30 ± 5 and -5 minutes on Day 1. Day 85 serial vital sign measures were taken in the sitting position prior to spirometry assessments pre-dose at -30 ± 5 and -5 minutes, then post-dose at 30 (±5) minutes, 1hr (± 10 min), 2hr (± 10 min), 3hr (± 10 min), 4hr (± 10 min), 5hr (± 10 min) and 6 hr (± 10 min).
Serial heart rate and blood pressure measurements that were elevated to the following criteria were considered clinically significant:
Systolic blood pressure: > 160 beats/minute Diastolic blood pressure: >100 beats/minute Heart rate: >120 beats/minute"|Day 8, Day 85|Safety population||participants|||Number
692740|NCT01424813|Secondary|Physical Examination Findings Shifts From Baseline to Endpoint by Treatment Group|Physical exam was recorded as normal or abnormal based on physician assessment. Format for results is: Test Baseline/Endpoint HEENT = head, eyes, ears, nose, throat|Day 1 (Baseline), Day 85|Safety population. Only participants with both baseline and endpoint physical examination findings are summarized. Two placebo participants were missing endpoint physical examinations.||participants|||Number
692741|NCT01424813|Secondary|Participants With Adverse Events|Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 to Day 92|Safety analysis set||participants|||Number
692742|NCT01424813|Secondary|Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 85|"FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. The baseline was the average of the 2 pre-dose FEV1 measurements on that study day. The baseline-adjustment refers to change from baseline at each post dose timepoint recorded on Day 85.
FEV1 was measured using spirometry. Spirometry assessments were obtained predose at -30 ± 5, and - 5 minutes, then post dose at 5 ± 2, 15 ± 5, 30 ± 5, 45 ± 5 minutes, and at 1hr ± 5 min, 2hr ± 5 min, 3hr ± 5 min, 4hr ± 5 min, 5hr ± 5 min, and 6hr ± 5 min."|Day 85|Full analysis set of participants with data at the time point||L*hr||95% Confidence Interval|Mean
692743|NCT01424813|Secondary|Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 8|"FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. The baseline was the average of the 2 pre-dose FEV1 measurements on that study day. The baseline-adjustment refers to change from baseline at each post dose timepoint recorded on Day 8.
FEV1 was measured using spirometry. Spirometry assessments were obtained predose at -30 ± 5, and - 5 minutes, then post dose at 5 ± 2, 15 ± 5, 30 ± 5, 45 ± 5 minutes, and at 1hr ± 5 min, 2hr ± 5 min, 3hr ± 5 min, 4hr ± 5 min, 5hr ± 5 min, and 6hr ± 5 min."|Day 8|Full analysis set of participants with data at the time point||L*hr||95% Confidence Interval|Mean
692746|NCT01424813|Other Pre-specified|Duration of Response on Days 1, 8 and 85|Duration of response measured from the time post-dosing to the first time after the response onset (increase ≥15% above baseline) when the FEV1 decreases to less than 15% above baseline (within 6 hours after dosing) for those who responded within 30 minutes|Day 1, Day 8, Day 85||||||
692747|NCT01424813|Other Pre-specified|Time to Onset of Effect (Change in FEV1 of 15% From Baseline Within 30 Minutes Postdose)for Those Who Responded in 30 Minutes||Day 1, Day 8, Day 85||||||
692748|NCT01424813|Other Pre-specified|Duration of Response Measured From the Time Post-dosing to the First Time After the Response Onset (Increase ≥12% Above Baseline) When the FEV1 Decreases to Less Than 12% Above Baseline (Within 6 Hours After Dosing) for Those Who Responded in 30 Minutes||Day 1, Day 8, Day 85||||||
692749|NCT01424813|Other Pre-specified|Time to Onset of Effect (Change in FEV1 of 12% From Baseline Within 30 Minutes Postdose)||Day 1, Day 8, Day 85||||||
692750|NCT01424813|Other Pre-specified|Maximum Percent Change From Baseline in FEV1 Within 2 Hours Post Dose on Day 85||Day 85||||||
692751|NCT01424813|Other Pre-specified|Maximum Percent Change From Baseline in FEV1 Within 2 Hours Post Dose on Day 8||Day 8||||||
692752|NCT01424813|Other Pre-specified|Maximum Percent Change From Baseline in FEV1 Within 2 Hours Post Dose on Day 1||Day 1||||||
692753|NCT01424813|Other Pre-specified|Maximum Percent Change From Baseline in FEV1 Within 2 Hours Post Dose Over the 12-week Treatment Period||Day 1, Day 8, Day 85||||||
692754|NCT01424813|Other Pre-specified|Percent Change From Baseline in FEV1 AUC||Day 85||||||
692755|NCT01424813|Other Pre-specified|Percent Change From Baseline in FEV1 AUC||Day 8||||||
692756|NCT01424813|Other Pre-specified|Percent Change From Baseline in FEV1 AUC 0-6||Day 1||||||
692757|NCT01424813|Other Pre-specified|Percent Change From Baseline in FEV1 AUC 0-6 Over the 12-week Treatment Period||Day 1, Day 8, Day 85||||||
692758|NCT01424813|Secondary|Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 1|"FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. The baseline was the average of the 2 pre-dose FEV1 measurements on that study day. The baseline-adjustment refers to change from baseline at each post dose timepoint recorded on Day 1.
FEV1 was measured using spirometry. Spirometry assessments were obtained predose at -30 ± 5, and - 5 minutes, then post dose at 5 ± 2, 15 ± 5, 30 ± 5, 45 ± 5 minutes, and at 1hr ± 5 min, 2hr ± 5 min, 3hr ± 5 min, 4hr ± 5 min, 5hr ± 5 min, and 6hr ± 5 min."|Day 1|Full analysis set||L*hr||95% Confidence Interval|Mean
692759|NCT01424813|Primary|Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) Over the 12-week Treatment Period|"FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. It represents the weighted average (by the trapezoidal rule) of FEV1 AUC 0-6 measures adjusted for the baseline measure (i.e., change from baseline at each timepoint) recorded on days 1, 8 and 85 of the treatment period. The baseline for each study day was the average of the 2 pre-dose FEV1 measurements on that study day.
FEV1 was measured using spirometry. Spirometry assessments were obtained predose at -30 ± 5, and - 5 minutes, then post dose at 5 ± 2, 15 ± 5, 30 ± 5, 45 ± 5 minutes, and at 1hr ± 5 min, 2hr ± 5 min, 3hr ± 5 min, 4hr ± 5 min, 5hr ± 5 min, and 6hr ± 5 min."|Day 1, Day 8 and Day 85|Full analysis set which includes all participants in the intent-to-treat (ITT) population who received at least 1 dose of study medication and had at least 1 post-baseline assessment.||L*hr||Standard Error|Mean
692760|NCT01424644|Secondary|Number of Subjects With Unsolicited Adverse Events When Tdap and HPV Are Concomitantly Administered With MenACWY-CRM Compared to When Tdap and HPV Are Concomitantly Administered With Placebo|"The number of subjects reporting any unsolicited adverse reactions (AEs) when Tdap and HPV are concomitantly administered with MenACWY-CRM as compared to when Tdap and HPV vaccine are concomitantly administered with placebo.
Note: A total of 2 MenACWY-CRM+Tdap+HPV subjects reported AEs leading to premature withdrawal – one subject due to treatment emergent AE and another subject prior to study vaccination on day 1."|Throughout the study (Day 1 to Day 211).|Analysis was done on overall safety population - All subjects in the exposed population who provided postvaccination and post-baseline safety data.||Subjects|||Number
692761|NCT01424644|Secondary|Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap and HPV Are Concomitantly Administered With MenACWY-CRM Compared to When Tdap and HPV Are Concomitantly Administered With Placebo|The number of subjects reporting solicited local and systemic reactions following concomitant administration of MenACWY-CRM vaccine, Tdap and HPV vaccine as compared to concomitant administration of placebo with Tdap and HPV.|Day 1-7 after any vaccination.|Analysis was done on solicited safety Set - All subjects in the exposed population who provided solicited AEs.||Subjects|||Number
692762|NCT01424644|Secondary|Geometric Mean hSBA Titers Against N. Meningitidis Serogroups A,C,W and Y at 1 Month After Men ACWY Vaccination.|The immunogenicity was assessed in terms of geometric mean hSBA titers of MenACWY when administered concomitantly with Tdap and HPV at 1 month after 1 dose of MenACWY vaccination.|1 month post MenACWY-CRM vaccination.|Analysis was done on the MenACWY per-protocol population - all subjects who received all the relevant doses of vaccine correctly, and provided evaluable serum samples at baseline and one month postvaccination for at least one serogroup, and had no major protocol violation as defined prior to unblinding.||Titers||95% Confidence Interval|Geometric Mean
692763|NCT01424644|Primary|Geometric Mean Concentrations of Antibodies Against Pertussis Antigens After Concomitant Administration of Tdap With HPV and MenACWY-CRM Compared to Concomitant Administration of Tdap With HPV and Placebo|The geometric mean concentrations (GMCs) of antibodies against pertussis antigens (PT, FHA and PRN), as measured by ELISA, following concomitant administration of Tdap with HPV and MenACWY-CRM as compared to concomitant administration of Tdap with HPV and placebo.|1 month post Tdap vaccination.|Analysis was done on the Tdap per-protocol population.||EU/mL||95% Confidence Interval|Geometric Mean
692783|NCT01424501|Secondary|Frequency of M72-specific CD8+ T Cells Per Million Cells Expressing Any Combination of Immune Markers|Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0 - PRE), post-dose 1 (Days 7 – D7 and 30 – D30), post-dose 2 (Days 37 – D37, 60 – D60 and 210 – D210)|The analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects who did not meet any of the criteria for elimination from ATP analysis,who complied with the procedures and intervals defined in the protocol and for whom data concerning immunogenicity endpoint measures were available at the time of each analysis.||T cells/million cells||Inter-Quartile Range|Median
692764|NCT01424644|Primary|Percentages of Subjects With Anti-diphtheria and Anti-tetanus Antibody Concentrations ≥ 0.1 IU/mL When Tdap is Administered Concomitantly With HPV and MenACWY-CRM Vaccine Compared to Tdap Given Concomitantly With HPV and Placebo|The percentages of subjects with anti-diphtheria and anti-tetanus antibody concentrations ≥ 0.1 IU/mL (as measured by ELISA) following concomitant administration of Tdap with HPV and MenACWY-CRM vaccine as compared to concomitant administration of Tdap with HPV and placebo.|1 month post Tdap vaccination.|Analysis was done on the Tdap per-protocol population, i.e., all subjects who received all the relevant doses of vaccine correctly, and provided serology results at one month postvaccination, and had no major protocol violation as defined prior to unblinding.||percentages of subjects||95% Confidence Interval|Number
692765|NCT01423617|Secondary|Global Evaluation of Efficacy by Subjects|"The subjects evaluate independently the efficacy of the investigational product, using a scale with scores of very good, good, moderate and poor."|12 weeks||||||
692766|NCT01423617|Secondary|Global Evaluation of Safety by Subjects|"The subjects evaluate independently the safety of the investigational product, using a scale with scores of “very good”, “good”, “moderate” and “poor."|12 weeks||||||
692767|NCT01423617|Secondary|Global Evaluation of Safety by Investigators|"The investigators evaluate independently the safety of the investigational product, using a scale with scores of “very good”, “good”, “moderate” and “poor."|12 weeks||||||
692768|NCT01423617|Secondary|Changes in Body Fat Free Mass (kg)||12 weeks||||||
692769|NCT01423617|Secondary|Subjects' Global Feeling of Satiety|Subject’s feeling of satiety (subsequent to the three main meals) is judged globally by the subjects on the basis of a 4 point rating scale: 0 = ”no”; 1 = ”slightly”, 2 = ”moderate” and 3 = ”strong”.|12 weeks||||||
692770|NCT01423617|Secondary|Changes in Hunger, Eating, and Food-craving Related Items From the Control of Eating Questionnaire (COEQ)||12 weeks||||||
692771|NCT01423617|Secondary|Changes in Body Fat Content (%)||12 weeks||||||
692772|NCT01423617|Secondary|Changes in Waist-hip-ratio||12 weeks||||||
692773|NCT01423617|Secondary|Changes in Hip Circumference||12 weeks|||cm||Standard Deviation|Mean
692774|NCT01423617|Secondary|Changes in Waist Circumference (cm)||12 weeks|||cm||Standard Deviation|Mean
692775|NCT01423617|Secondary|Number of Subjects Who Lost at Least 3% of Baseline Body Weight||12 weeks|||participants|||Number
692776|NCT01423617|Primary|Change in Mean Body Fat (kg)|Change in mean body fat at week 12 compared to baseline|12 weeks|||kg||Standard Deviation|Mean
692777|NCT01423617|Primary|Change in Mean Body Weight (kg)|Change in mean body weight at week 12 compared to baseline.|12 weeks|||kg||Standard Deviation|Mean
692778|NCT01424501|Secondary|Frequency of M72-specific CD8+ T Cells Per Million Cells Expressing Any Combination of Immune Markers|Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0 - PRE), post-dose 1 (Days 7 – D7 and 30 – D30), post-dose 2 (Days 37 – D37, 60 – D60 and 210 – D210)|The analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects who did not meet any of the criteria for elimination from ATP analysis,who complied with the procedures and intervals defined in the protocol and for whom data concerning immunogenicity endpoint measures were available at the time of each analysis.||T cells/million cells||Inter-Quartile Range|Median
692779|NCT01424501|Secondary|Frequency of M72-specific CD8+ T Cells Per Million Cells Expressing Any Combination of Immune Markers|Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0 - PRE), post-dose 1 (Days 7 – D7 and 30 – D30), post-dose 2 (Days 37 – D37, 60 – D60 and 210 – D210)|The analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects who did not meet any of the criteria for elimination from ATP analysis,who complied with the procedures and intervals defined in the protocol and for whom data concerning immunogenicity endpoint measures were available at the time of each analysis.||T cells/million cells||Inter-Quartile Range|Median
692780|NCT01424501|Secondary|Frequency of M72-specific CD8+ T Cells Per Million Cells Expressing Any Combination of Immune Markers|Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0 - PRE), post-dose 1 (Days 7 – D7 and 30 – D30), post-dose 2 (Days 37 – D37, 60 – D60 and 210 – D210)|The analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects who did not meet any of the criteria for elimination from ATP analysis,who complied with the procedures and intervals defined in the protocol and for whom data concerning immunogenicity endpoint measures were available at the time of each analysis.||T cells/million cells||Inter-Quartile Range|Median
692781|NCT01424501|Secondary|Frequency of M72-specific CD8+ T Cells Per Million Cells Expressing Any Combination of Immune Markers|Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0 - PRE), post-dose 1 (Days 7 – D7 and 30 – D30), post-dose 2 (Days 37 – D37, 60 – D60 and 210 – D210)|The analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects who did not meet any of the criteria for elimination from ATP analysis,who complied with the procedures and intervals defined in the protocol and for whom data concerning immunogenicity endpoint measures were available at the time of each analysis.||T cells/million cells||Inter-Quartile Range|Median
692782|NCT01424501|Secondary|Frequency of M72-specific CD8+ T Cells Per Million Cells Expressing Any Combination of Immune Markers|Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0 - PRE), post-dose 1 (Days 7 – D7 and 30 – D30), post-dose 2 (Days 37 – D37, 60 – D60 and 210 – D210)|The analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects who did not meet any of the criteria for elimination from ATP analysis,who complied with the procedures and intervals defined in the protocol and for whom data concerning immunogenicity endpoint measures were available at the time of each analysis.||T cells/million cells||Inter-Quartile Range|Median
692803|NCT01424501|Primary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. They were assessed after each dose (Dose 1 = D1, Dose 2 = D2) and across doses.|During the 7 day (Days 0-6), after each vaccine dose|The analysis was performed on the Total Vaccinated cohort which included all subjects with study vaccine administered and for whom data were available.||Subjects|||Number
692784|NCT01424501|Secondary|Frequency of M72-specific CD8+ T Cells Per Million Cells Expressing Any Combination of Immune Markers|Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0 - PRE), post-dose 1 (Days 7 – D7 and 30 – D30), post-dose 2 (Days 37 – D37, 60 – D60 and 210 – D210)|The analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects who did not meet any of the criteria for elimination from ATP analysis,who complied with the procedures and intervals defined in the protocol and for whom data concerning immunogenicity endpoint measures were available at the time of each analysis.||T cells/million cells||Inter-Quartile Range|Median
692785|NCT01424501|Secondary|Frequency of M72-specific CD8+ T Cells Per Million Cells Expressing Any Combination of Immune Markers|Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0 - PRE), post-dose 1 (Days 7 – D7 and 30 – D30), post-dose 2 (Days 37 – D37, 60 – D60 and 210 – D210)|The analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects who did not meet any of the criteria for elimination from ATP analysis,who complied with the procedures and intervals defined in the protocol and for whom data concerning immunogenicity endpoint measures were available at the time of each analysis.||T cells/million cells||Inter-Quartile Range|Median
692786|NCT01424501|Secondary|Frequency of M72-specific CD8+ T Cells Per Million Cells Expressing 2 or More Immune Markers Among 6|Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a), CD40-ligand (CD40-L), Interleukin-17 (IL-17) and/or Interleukin-17 (IL-17).|Prior to dose 1 (Day 0 - PRE), post-dose 1 (Days 7 – D7 and 30 – D30), post-dose 2 (Days 37 – D37, 60 – D60 and 210 – D210)|The analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects who did not meet any of the criteria for elimination from ATP analysis,who complied with the procedures and intervals defined in the protocol and for whom data concerning immunogenicity endpoint measures were available at the time of each analysis.||T cells/million cells||Inter-Quartile Range|Median
692787|NCT01424501|Secondary|Frequency of M72-specific CD8+ T Cells Per Million Cells Expressing at Least 2 Immune Markers|Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0 - PRE), post-dose 1 (Days 7 – D7 and 30 – D30), post-dose 2 (Days 37 – D37, 60 – D60 and 210 – D210)|The analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects who did not meet any of the criteria for elimination from ATP analysis,who complied with the procedures and intervals defined in the protocol and for whom data concerning immunogenicity endpoint measures were available at the time of each analysis.||T cells/million cells||Inter-Quartile Range|Median
692788|NCT01424501|Secondary|Frequency of M72-specific CD4+ T Cells Per Million Cells Expressing Any Combination of Immune Markers|Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0 - PRE), post-dose 1 (Days 7 – D7 and 30 – D30), post-dose 2 (Days 37 – D37, 60 – D60 and 210 – D210)|The analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects who did not meet any of the criteria for elimination from ATP analysis,who complied with the procedures and intervals defined in the protocol and for whom data concerning immunogenicity endpoint measures were available at the time of each analysis.||T cells/million cells||Inter-Quartile Range|Median
692789|NCT01424501|Secondary|Frequency of M72-specific CD4+ T Cells Per Million Cells Expressing Any Combination of Immune Markers|Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0 - PRE), post-dose 1 (Days 7 – D7 and 30 – D30), post-dose 2 (Days 37 – D37, 60 – D60 and 210 – D210)|The analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects who did not meet any of the criteria for elimination from ATP analysis,who complied with the procedures and intervals defined in the protocol and for whom data concerning immunogenicity endpoint measures were available at the time of each analysis.||T cells/million cells||Inter-Quartile Range|Median
692790|NCT01424501|Secondary|Frequency of M72-specific CD4+ T Cells Per Million Cells Expressing Any Combination of Immune Markers|Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0 - PRE), post-dose 1 (Days 7 – D7 and 30 – D30), post-dose 2 (Days 37 – D37, 60 – D60 and 210 – D210)|The analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects who did not meet any of the criteria for elimination from ATP analysis,who complied with the procedures and intervals defined in the protocol and for whom data concerning immunogenicity endpoint measures were available at the time of each analysis.||T cells/million cells||Inter-Quartile Range|Median
692791|NCT01424501|Secondary|Frequency of M72-specific CD4+ T Cells Per Million Cells Expressing Any Combination of Immune Markers|Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0 - PRE), post-dose 1 (Days 7 – D7 and 30 – D30), post-dose 2 (Days 37 – D37, 60 – D60 and 210 – D210)|The analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects who did not meet any of the criteria for elimination from ATP analysis,who complied with the procedures and intervals defined in the protocol and for whom data concerning immunogenicity endpoint measures were available at the time of each analysis.||T cells/million cells||Inter-Quartile Range|Median
692792|NCT01424501|Secondary|Frequency of M72-specific CD4+ T Cells Per Million Cells Expressing Any Combination of Immune Markers|Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0 - PRE), post-dose 1 (Days 7 – D7 and 30 – D30), post-dose 2 (Days 37 – D37, 60 – D60 and 210 – D210)|The analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects who did not meet any of the criteria for elimination from ATP analysis,who complied with the procedures and intervals defined in the protocol and for whom data concerning immunogenicity endpoint measures were available at the time of each analysis.||T cells/million cells||Inter-Quartile Range|Median
693449|NCT01414413|Secondary|Reporting of HIV-positive Results|Comparison of the proportion of all cluster adults confiding HIV-positive results to the resident community counsellor between study arms during the 1-year study period|The first 6-months following availability of home-based HIV testing|||participants|||Number
692793|NCT01424501|Secondary|Frequency of M72-specific CD4+ T Cells Per Million Cells Expressing Any Combination of Immune Markers|Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0 - PRE), post-dose 1 (Days 7 – D7 and 30 – D30), post-dose 2 (Days 37 – D37, 60 – D60 and 210 – D210)|The analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects who did not meet any of the criteria for elimination from ATP analysis,who complied with the procedures and intervals defined in the protocol and for whom data concerning immunogenicity endpoint measures were available at the time of each analysis.||T cells/million cells||Inter-Quartile Range|Median
692794|NCT01424501|Secondary|Frequency of M72-specific CD4+ T Cells Per Million Cells Expressing Any Combination of Immune Markers|Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0 - PRE), post-dose 1 (Days 7 – D7 and 30 – D30), post-dose 2 (Days 37 – D37, 60 – D60 and 210 – D210)|The analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects who did not meet any of the criteria for elimination from ATP analysis,who complied with the procedures and intervals defined in the protocol and for whom data concerning immunogenicity endpoint measures were available at the time of each analysis.||T cells/million cells||Inter-Quartile Range|Median
692795|NCT01424501|Secondary|Frequency of M72-specific CD4+ T Cells Per Million Cells Expressing Any Combination of Immune Markers|Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0 - PRE), post-dose 1 (Days 7 – D7 and 30 – D30), post-dose 2 (Days 37 – D37, 60 – D60 and 210 – D210)|The analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects who did not meet any of the criteria for elimination from ATP analysis,who complied with the procedures and intervals defined in the protocol and for whom data concerning immunogenicity endpoint measures were available at the time of each analysis.||T cells/million cells||Inter-Quartile Range|Median
692796|NCT01424501|Secondary|Frequency of M72-specific CD4+ T Cells Per Million Cells Expressing 2 or More Immune Markers Among 6|Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a), CD40-ligand (CD40-L), Interleukin-17 (IL-17) and/or Interleukin-17 (IL-17).|Prior to dose 1 (Day 0 - PRE), post-dose 1 (Days 7 – D7 and 30 – D30), post-dose 2 (Days 37 – D37, 60 – D60 and 210 – D210)|The analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects who did not meet any of the criteria for elimination from ATP analysis,who complied with the procedures and intervals defined in the protocol and for whom data concerning immunogenicity endpoint measures were available at the time of each analysis.||T cells/million cells||Inter-Quartile Range|Median
692797|NCT01424501|Secondary|Frequency of M72-specific CD4+ T Cells Per Million Cells Expressing Any Combination of the Different Immune Markers|Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0 - PRE), post-dose 1 (Days 7 – D7 and 30 – D30), post-dose 2 (Days 37 – D37, 60 – D60 and 210 – D210)|The analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects who did not meet any of the criteria for elimination from ATP analysis,who complied with the procedures and intervals defined in the protocol and for whom data concerning immunogenicity endpoint measures were available at the time of each analysis.||T cells/million cells||Inter-Quartile Range|Median
692798|NCT01424501|Secondary|Concentrations of Mycobacterium Tuberculosis Fusion Protein M72|Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EU/mL).|Prior to dose 1 (Day 0 - PRE), post-dose 1 (Day 30 – D30), post-dose 2 (Days 60 – D60 and 210 – D210)|The analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects who did not meet any of the criteria for elimination from ATP analysis,who complied with the procedures and intervals defined in the protocol and for whom data concerning immunogenicity endpoint measures were available at the time of each analysis.||EU/mL||95% Confidence Interval|Geometric Mean
692799|NCT01424501|Secondary|Number of Subjects With Anti-mycobacterium Tuberculosis Fusion Protein M72 Antibodies|Cut-off values assessed were greater than or equal to 2.8, measured by ELISA (Enzyme Linked Immunosorbent Assay) in the sera of subjects seronegative before vaccination.|Prior to dose 1 (Day 0 - PRE), post-dose 1 (Day 30 – D30), post-dose 2 (Days 60 – D60 and 210 – D210)|The analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects who did not meet any of the criteria for elimination from ATP analysis,who complied with the procedures and intervals defined in the protocol and for whom data concerning immunogenicity endpoint measures were available at the time of each analysis.||Subjects|||Number
692800|NCT01424501|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Up to day 210|The analysis was performed on the Total Vaccinated cohort which included all subjects with study vaccine administered and for whom data were available.||Subjects|||Number
692801|NCT01424501|Primary|Number of Subjects With Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 30 day (Days 0-29), after vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with study vaccine administered and for whom data were available.||Subjects|||Number
692802|NCT01424501|Primary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, malaise, myalgia and temperature [body temperature equal to or above 37.5 degrees Celsius (°C)]. The symptoms were assessed after each dose (Dose 1 = D1, Dose 2 = D2) and across doses.|During the 7 day (Days 0-6), after each vaccine dose|The analysis was performed on the Total Vaccinated cohort which included all subjects with study vaccine administered and for whom data were available.||Subjects|||Number
693480|NCT01414166|Secondary|Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 16|The percentage change from baseline in participants' Apo B was to be evaluated at study Week 16.|Baseline and Week 16|Due to early study termination, this efficacy endpoint was not analyzed.|||||
692804|NCT01424306|Secondary|Adipose Tissue Inflammation - Tissue Expression of IFN-gamma mRNA|A subgroup of the study population will be enrolled into an ancillary study that will aim to assess the effects of consuming fructose- vs. high-fructose corn syrup- vs. glucose-sweetened beverages on adipose tissue inflammation. Adipose tissue inflammation will be assessed by whole adipose tissue gene expression analysis of IFN-gamma mRNA. Abdominal subcutaneous adipose tissue samples will be obtained from subjects enrolled into the ancillary study by needle aspiration biopsy on day 9 of each 8-day dietary period.|End (day 9) of each diet period.|A subset of the study population opted to undergo voluntary adipose tissue biopsy||copy number/ng total RNA||Inter-Quartile Range|Median
692805|NCT01424306|Secondary|Adipose Tissue Inflammation - Tissue Expression of CCL2 mRNA|A subgroup of the study population will be enrolled into an ancillary study that will aim to assess the effects of consuming fructose- vs. high-fructose corn syrup- vs. glucose-sweetened beverages on adipose tissue inflammation. Adipose tissue inflammation will be assessed by whole adipose tissue gene expression analysis of CCL2 mRNA. Abdominal subcutaneous adipose tissue samples will be obtained from subjects enrolled into the ancillary study by needle aspiration biopsy on day 9 of each 8-day dietary period.|End (day 9) of each diet period.|A subset of the study population opted to undergo voluntary adipose tissue biopsy||copy number/ng total RNA||Inter-Quartile Range|Median
692806|NCT01424306|Secondary|Adipose Tissue Inflammation - Tissue Expression of IL-10 mRNA|A subgroup of the study population will be enrolled into an ancillary study that will aim to assess the effects of consuming fructose- vs. high-fructose corn syrup- vs. glucose-sweetened beverages on adipose tissue inflammation. Adipose tissue inflammation will be assessed by whole adipose tissue gene expression analysis of IL-10 mRNA. Abdominal subcutaneous adipose tissue samples will be obtained from subjects enrolled into the ancillary study by needle aspiration biopsy on day 9 of each 8-day dietary period.|End (day 9) of each diet period.|A subset of the study population opted to undergo voluntary adipose tissue biopsy||copy number/ng total RNA||Inter-Quartile Range|Median
692807|NCT01424306|Secondary|Adipose Tissue Inflammation - Tissue Expression of IL-6 mRNA|A subgroup of the study population will be enrolled into an ancillary study that will aim to assess the effects of consuming fructose- vs. high-fructose corn syrup- vs. glucose-sweetened beverages on adipose tissue inflammation. Adipose tissue inflammation will be assessed by whole adipose tissue gene expression analysis of IL-6 mRNA. Abdominal subcutaneous adipose tissue samples will be obtained from subjects enrolled into the ancillary study by needle aspiration biopsy on day 9 of each 8-day dietary period.|End (day 9) of each diet period.|A subset of the study population opted to undergo voluntary adipose tissue biopsy||copy number/ng total RNA||Inter-Quartile Range|Median
692808|NCT01424306|Secondary|Adipose Tissue Inflammation - Tissue Expression of IL-1beta mRNA|A subgroup of the study population will be enrolled into an ancillary study that will aim to assess the effects of consuming fructose- vs. high-fructose corn syrup- vs. glucose-sweetened beverages on adipose tissue inflammation. Adipose tissue inflammation will be assessed by whole adipose tissue gene expression analysis of IL-1beta mRNA. Abdominal subcutaneous adipose tissue samples will be obtained from subjects enrolled into the ancillary study by needle aspiration biopsy on day 9 of each 8-day dietary period.|End (day 9) of each diet period.|A subset of the study population opted to undergo voluntary adipose tissue biopsy||copy number/ng total RNA||Inter-Quartile Range|Median
692809|NCT01424306|Secondary|Adipose Tissue Inflammation - Tissue Expression of TNF-alpha mRNA|A subgroup of the study population will be enrolled into an ancillary study that will aim to assess the effects of consuming fructose- vs. high-fructose corn syrup- vs. glucose-sweetened beverages on adipose tissue inflammation. Adipose tissue inflammation will be assessed by whole adipose tissue gene expression analysis of TNF-alpha mRNA. Abdominal subcutaneous adipose tissue samples will be obtained from subjects enrolled into the ancillary study by needle aspiration biopsy on day 9 of each 8-day dietary period.|End (day 9) of each diet period.|A subset of the study population opted to undergo voluntary adipose tissue biopsy||copy number/ng total RNA||Standard Deviation|Mean
692810|NCT01424306|Secondary|Fasting Plasma Lipopolysaccharide-binding Protein (LBP)|Lipopolysaccharide-binding protein (LBP) will be measured by enzyme-linked immunosorbent assay in fasting plasma collected on day 9 of each diet period. LBP is an acute phase protein secreted by the liver in response to endotoxin (lipopolysaccharide) exposure.|End (day 9) of each diet period.|All completed participants combined for protocol analysis||ug/mL||Inter-Quartile Range|Median
692811|NCT01424306|Secondary|Fasting Plasma Zonulin Concentrations|Zonulin concentrations will be measured by enzyme-linked immunosorbent assay in fasting plasma collected on day 9 of each diet period. Plasma zonulin is a marker of intestinal permeability.|End (day 9) of each diet period.|All completed participants combined in per protocol analysis||ng/mL||Standard Deviation|Mean
692812|NCT01424306|Secondary|Intestinal Permeability, as Assessed by the 5-hour Urinary Lactulose/Mannitol Test|Intestinal permeability will be assessed on day 9 of each diet period by administering a beverage containing 2 g of mannitol and 5 g of lactulose followed by collecting urine for 5 hours afterwards. Recovery of mannitol and lactulose in urine will be measured by gas chromatography, and will be indicative of the degree of intestinal permeability.|End (day 9) of each diet period.|All completed participants combined in per protocol analysis||ratio||Inter-Quartile Range|Median
692813|NCT01424306|Secondary|Mean Daily Calorie Intake|Mean daily calorie intake will be assessed during each of the three 8-day diet periods. All foods will be provided to the subjects in excess of what they are estimated to require, and calorie intake will be assessed by subtracting returned foods from foods administered.|The mean daily calorie intake during each of the 8-day diet periods will be calculated.|All completed participants combined in per protocol analysis||kcal/d||Standard Deviation|Mean
692814|NCT01424306|Secondary|Fasting Plasma Adiponectin|The concentration of adiponectin in fasting plasma will be measured by enzyme-linked immunosorbent assay at the end (day 9) of each 8-day dietary period.|End (day 9) of each diet period.|All completed participants combined in per protocol analysis||ng/mL||Standard Deviation|Mean
692815|NCT01424306|Primary|Fasting Plasma Interleukin-6 on Day 9 of Each Diet Period|The concentration of interleukin-6 in fasting plasma will be measured by high-sensitivity enzyme-linked immunosorbent assay at the end (day 9) of each 8-day dietary period.|End (day 9) of each diet period|All completed participants combined in per protocol analysis||pg/mL||Inter-Quartile Range|Median
692816|NCT01424306|Primary|Fasting Plasma C-reactive Protein|The concentration of C-reactive protein in fasting plasma will be measured by high-sensitivity assay at the beginning (day 1) and end (day 9) of each 8-day dietary period.|Beginning (day 1) and end (day 9) of each diet period.|All completed participants combined in per protocol analysis||mg/L||Inter-Quartile Range|Median
692817|NCT01424228|Secondary|Change From Baseline in the Short Form-36 Health Survey (SF-36) Score at Up to the Final On Treatment Assessment Value|The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Total score ranges from 0 (lowest level of health) - 100 (highest level of health) on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability (i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability). Higher scores are associated with better quality of life.|Baseline and Over 24 week treatment period|ITT population. Not all subjects in the ITT population had data for this outcome.||units on a scale||Standard Deviation|Mean
692818|NCT01424228|Secondary|Change From Baseline in the Patient Assessment of Constipation - Quality of Life (PAC-QOL) Score at Up to the Final On Treatment Assessment Value|The PAC-QOL is a validated 28-item questionnaire for the evaluation of quality of life in subjects with constipation. Items are rated on a 5-point Likert scale: 0=not at all/none of the time, 1=a little bit/a little bit of the time, 2=moderately/some of the time, 3=quite a bit/most of the time, 4=extremely/all of the time. Total score ranges from 0-112. Lower scores indicate improvement in symptoms. A 1-point improvement in PAC-QOL total score was considered clinically meaningful.|Baseline and Over 24 week treatment period|ITT population. Not all subjects in the ITT population had data for this outcome.||units on a scale||Standard Deviation|Mean
692819|NCT01424228|Secondary|Change From Baseline in the Patient Assessment of Constipation – Symptom (PAC-SYM) Questionnaire Score at Up to the Final On Treatment Assessment Value|The PAC-SYM is a validated 12-item questionnaire for the evaluation of severity of symptoms of constipation in subjects with constipation. Items are rated on a 5-point Likert scale: 0=absent, 1=mild, 2=moderate, 3=severe, 4=very severe. Total score ranges from 0 to 48. Lower scores indicate improvement in symptoms. A 1-point improvement in PAC-SYM total score was considered clinically meaningful.|Baseline and Over 24 week treatment period|ITT population. Not all subjects in the ITT population had data for this outcome.||units on a scale||Standard Deviation|Mean
692820|NCT01424228|Secondary|Change From Baseline in the Number of Days With Rescue Medication Taken Per Week at Up to 24 Weeks|Rescue medications include laxatives and enemas.|Baseline and Over 24 week treatment period|ITT population. Not all subjects in the ITT population had data for this outcome.||days/week||Standard Deviation|Mean
692821|NCT01424228|Secondary|Change From Baseline in the Number of Bisacodyl Tablets Taken Per Week at Up to 24 Weeks||Baseline and Over 24 week treatment period|ITT population. Not all subjects in the ITT population had data for this outcome.||tablets/week||Standard Deviation|Mean
692822|NCT01424228|Secondary|Time to First SCBM After Investigational Product Intake on Day 1 and Day 28||Day 1 and 28|Intent-to-Treat Population (ITT) includes all subjects randomized into the study who took at least 1 dose of investigational product. The 21 subjects with a risk of potential unblinding due to an error in the randomization system were excluded from the ITT Population to avoid the risk of bias to the study results.||hours||95% Confidence Interval|Median
692823|NCT01424228|Secondary|Change From Baseline in Percent SBM With Sensation of Complete Evacuation at Up to 24 Weeks||Baseline and Over 24 week treatment period|ITT population. Not all subjects in the ITT population had data for this outcome.||percentage of SBM||Standard Deviation|Mean
692824|NCT01424228|Secondary|Change From Baseline in Percent SCBM With No Straining and Severe/Very Severe Straining at Up to 24 Weeks||Baseline and Over 24 week treatment period|ITT population. Not all subjects in the ITT population had data for this outcome.||percentage of SCBM||Standard Deviation|Mean
692825|NCT01424228|Secondary|Change From Baseline in Straining Per SCBM at Up to 24 Weeks|Straining was evaluated on a 5-point scale (0=none, 1=mild, 2=moderate, 3=severe, or 4=very severe)|Baseline and Over 24 week treatment period|ITT population. Not all subjects in the ITT population had data for this outcome.||units on a scale||Standard Deviation|Mean
692826|NCT01424228|Secondary|Change From Baseline in Percent SCBM With a Consistency of Normal and Hard/Very Hard at Up to 24 Weeks||Baseline and Over 24 week treatment period|ITT population. Not all subjects in the ITT population had data for this outcome.||percentage of SCBM||Standard Deviation|Mean
692827|NCT01424228|Secondary|Change From Baseline in Average Consistency Per SCBM at Up to 24 Weeks|Consistency measured using the 7-point Bristol scale where 1-2 indicate constipation (=hard/very hard), 3-4 are ideal stools (=normal), and 5-7 tending toward diarrhea.|Baseline and Over 24 week treatment period|ITT population. Not all subjects in the ITT population had data for this outcome.||units on a scale||Standard Deviation|Mean
692828|NCT01424228|Secondary|Percent of Subjects With an Average Weekly Frequency of at Least 3 SCBM by 4-Week Treatment Period||Over 24 week treatment period|Intent-to-Treat Population (ITT) includes all subjects randomized into the study who took at least 1 dose of investigational product. The 21 subjects with a risk of potential unblinding due to an error in the randomization system were excluded from the ITT Population to avoid the risk of bias to the study results.||percentage of subjects|||Number
692829|NCT01424228|Secondary|Percent of Subjects With an Average Weekly Frequency of at Least 3 SCBM by Week||Over 24 week treatment period|Intent-to-Treat Population (ITT) includes all subjects randomized into the study who took at least 1 dose of investigational product. The 21 subjects with a risk of potential unblinding due to an error in the randomization system were excluded from the ITT Population to avoid the risk of bias to the study results.||percentage of subjects|||Number
692830|NCT01424228|Secondary|Change From Baseline in Spontaneous Complete Bowel Movements Per Week at Up to 24 Weeks||Baseline and Over 24 week treatment period|ITT population. Not all subjects in the ITT population had data for this outcome.||SCBM/week||Standard Deviation|Mean
692831|NCT01424228|Secondary|Average Number of Spontaneous Complete Bowel Movements (SCBM) Per Week Up to 24 Weeks||Over 24 week treatment period|ITT population. Not all subjects in the ITT population had data for this outcome.||SCBM/week||Standard Deviation|Mean
692832|NCT01424228|Secondary|Percentage of Subjects With an Increase of ≥1 Spontaneous Complete Bowel Movement (SCBM) Per Week Up to 24 Weeks||Over 24 week treatment period|Intent-to-Treat Population (ITT) includes all subjects randomized into the study who took at least 1 dose of investigational product. The 21 subjects with a risk of potential unblinding due to an error in the randomization system were excluded from the ITT Population to avoid the risk of bias to the study results.||percentage of subjects|||Number
693481|NCT01414166|Secondary|Percent Change From Baseline in Lipoprotein(a) (LP[a]) at Week 16|The pecentage change from baseline in participants LP(a) was to be evaluated at study Week 16.|Baseline and Week 16|Due to early study termination, this efficacy endpoint was not analyzed.|||||
692833|NCT01424228|Primary|The Percentage of Subjects With an Average of ≥3 Spontaneous Complete Bowel Movements (SCBM) Per Week Over the 24 Week Treatment Period|Spontaneous Bowel Movements defined as a bowel movement that is not preceded within a period of 24 hours by the intake of a laxative agent or by the use of an enema.|Over 24 week treatment period|Intent-to-Treat Population (ITT) includes all subjects randomized into the study who took at least 1 dose of investigational product. There were 21 subjects with a risk of potential unblinding due to an error in the randomization system who were excluded from the ITT Population to avoid the risk of bias to the study results.||percentage of subjects|||Number
692834|NCT01424189|Secondary|Rate of Severe Visual Disturbances/Distortions Reported on the Assessment of Photic Phenomena & Lens EffectS (APPLES) Questionnaire at Visit 5|"Visual disturbances/distortions were reported by the participant on the Assessment of Photic Phenomena and Lens EffectS (APPLES) questionnaire, a Patient Reported Outcome (PRO) questionnaire intended to evaluate 10 distinct visual phenomena associated with cataract extraction and IOL implantation. The first 20 questions addressed both the frequency and severity of the phenomena using a 4-point categorical scale ranging from never” to “always” (frequency) or “none” to “severe” (severity). The final (21st) question indicated whether the participant answered the questions based on experiences with or without glasses. The participant completed the assessment as a retrospective analysis of the previous week. Rate is presented as the percentage of participants with severity score severe for the visual phenomenon."|Month 12 from second eye implantation|This analysis population includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).||percentage of participants|||Number
692835|NCT01424189|Primary|Rate of Actual and Potential Secondary Surgical Interventions (SSIs) Related to the Optical Properties of the IOL for First and Second Operative Eyes Separately at Visit 5|The rate of actual and potential secondary surgical interventions (SSIs) related to the optical properties of the IOL was estimated. If an ocular surgical intervention was performed, it qualified as an actual SSI; however; if the participant met the protocol-specified criteria that would warrant an SSI, but didn’t actually undergo the SSI, it qualified as a potential SSI. Rate is presented as percentage of participants.|Month 12 from second eye implantation|This analysis population includes all participants with attempted IOL implantation (successful or aborted after contact with the eye). For participants with actual SSIs, performance testing outcomes conducted prior to the secondary intervention were carried forward to the final analysis.||percentage of participants|||Number
692836|NCT01424189|Primary|Mean Monocular Uncorrected Near Visual Acuity (UCNVA) at Fixed Distance at Visit 5|VA was measured monocularly without visual correction using a hand-held ETDRS chart at a fixed distance that differed by lens model implanted. The logMAR ETDRS near visual acuity chart was designed for use at 40 cm; results obtained at other distances were converted to reflect the change in apparent letter size that results from the change in distance. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the first operative eye.|Month 12 from second eye implantation|This analysis population includes all participants with successful IOL implantation in the first implanted eye with data at visit.||logMAR||Standard Deviation|Mean
692837|NCT01424189|Primary|Mean Monocular Uncorrected Distance Visual Acuity (UCDVA) at Fixed Distance at Visit 5|Visual acuity (VA) was measured monocularly (each eye separately) without visual correction using a 100% contrast ETDRS (Early Treatment of Diabetic Retinopathy Study) chart positioned 4 meters (m) from the participant under well-lit conditions. +0.25 diopter (D) spherical power was applied to correct for optical infinity. VA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the first operative eye.|Month 12 from second eye implantation|This analysis population includes all participants with successful IOL implantation in the first implanted eye with data at visit.||logMAR|eyes|Standard Error|Least Squares Mean
692838|NCT01424072|Primary|Coping Strategy: Social Support Domain|"Scale information: Folkman and Lazarus Coping Strategy Inventory with 66 items. The scale is constructed by 8 different domains: confrontation, distancing, self-control, social support, acceptance of responsibility, escape avoidance, problem solving and positive reappraisal.The questions are scored by Likert scale: 0 (not used this strategy); 1 (used somewhat); 2 (used enough) and 3(used in large quantities) to the 66 items (Folkman and Lazarus Coping Strategy Inventory). It performed a summation of items and defined the scores: 0-4 points (not use this strategy), 5-9 (use this strategy a bit), 10-14 ( use this strategy quite) 14-18 (use strategy plenty)."|after 60 days|Of the 109 subjects, four were eliminated for having a low level of stress and three for not belonging to nursing staff;seven didn’t appear in the first session. Some lost sessions and were also excluded. One abandoned the treatment because of the side effects, one didn’t complete the questionnaire, seven went on vacation or sick leave(2).||units on a scale||Standard Deviation|Mean
692839|NCT01424072|Primary|Coping Strategy: Distancing Domain|The questions are scored by Likert scale: 0 (not used this strategy); 1 (used somewhat); 2 (used enough) and 3(used in large quantities) to the 66 items (Folkman and Lazarus Coping Strategy Inventory). It performed a summation of items and defined the scores: 0-4 points (not use this strategy), 5-9 (use this strategy a bit), 10-14 ( use this strategy quite) 14-18 (use strategy plenty).|after 75 days|||units on a scale||Standard Deviation|Mean
692840|NCT01424072|Primary|Coping Strategy: Domain Social Support(After 60 Days)|"Scale information: Folkman and Lazarus Coping Strategy Inventory with 66 items. The scale is constructed by 8 different domains: confrontation, distancing, self-control, social support, acceptance of responsibility, escape avoidance, problem solving and positive reappraisal.The questions are scored by Likert scale: 0 (not used this strategy); 1 (used somewhat); 2 (used enough) and 3(used in large quantities) to the 66 items (Folkman and Lazarus Coping Strategy Inventory). It performed a summation of items and defined the scores: 0-4 points (not use this strategy), 5-9 (use this strategy a bit), 10-14 ( use this strategy quite) 14-18 (use strategy plenty)."|after 60days|Of the 109 subjects, four were eliminated for having a low level of stress and three for not belonging to nursing staff;seven didn’t appear in the first session. Some lost sessions and were also excluded. One abandoned the treatment because of the side effects, one didn’t complete the questionnaire, seven went on vacation or sick leave(2).||units on a scale||Standard Deviation|Mean
694337|NCT01402102|Primary|Changes in LDL-cholesterol(Low Density Lipoprotein - Cholesterol)|LDL-C(Low Density Lipoprotein - cholesterol) was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis||mg/dl||Standard Deviation|Mean
692841|NCT01424072|Secondary|Stress Scale|Scale information: Stress Symptoms List (LSS)with 60 items (better outcome)Low score: 12/29 points; Medium score: 30/60 points; High score: 61/120 points; Very high score (worse outcome): >120 points.|after 60 days|Of the 109 subjects, four were eliminated for having a low level of stress and three for not belonging to nursing staff;seven didn’t appear in the first session. Some lost sessions and were also excluded. One abandoned the treatment because of the side effects, one didn’t complete the questionnaire, seven went on vacation or sick leave(2).||units on a scale||Standard Deviation|Mean
692842|NCT01424033|Primary|Pulmonary Function Tests|Not recorded. Study terminated due to departure of PI.|Every 3 months||||||
692843|NCT01423916|Secondary|Number of Participants With Maximum Change From Baseline to the On-treatment ECG Values on Day 11 for Heart Rate (HR), PR Interval, and QRS Interval.|Changes in HR with values 25% decrease from Day −1 and HR < 50 bpm and 25% increase from Day −1 and HR > 100 bpm; PR interval of greater than or equal to 25% change from Day −1 and PR > 200 msec; QRS interval of Greater than or equal to 25% change from Day −1 and > 100 msec were noted on Day 11. Maximum change from baseline to the on-treatment ECG values on Day 11 for heart rate.|Day 11|Electrocardiograms were sampled at predose and approximately 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose on Days -1, 1, 11, and 12.||participants|||Number
692844|NCT01423916|Secondary|Number of Participants With New Incidence of ECG Morphology Abnormalities on Day 11.|Participants with incidence of ECG morphology abnormalities on Day 11 (participants who had abnormalities during Day 11 but not at Day -1) were noted. Types of abnormalities included appearance of abnormal U waves, negative T waves, elevation of ST segment, depression of ST segment, second degree heart block, third degree heart block, right bundle branch block, and left bundle branch block. ECGs were sampled at predose and approximately 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose on Days -1, 1, 11, and 12.|Day 11|Number of participants who took at least one dose of study drug post Day −1, and had evaluations of the ECG parameters at Baseline and Post Baseline.||participants|||Number
692845|NCT01423916|Secondary|Number Participants Noted With New Incidence of QT Interval of > 500 Msec on Day 11.|The number of participants who were noted with new incidence of QT interval of > 500 msec on Day 11 and a 12-lead ECG was used.|Day 11|Assay sensitivity sample dataset demonstrated the ability of the trial that detected the effect of moxifloxacin on the QTcI that consisted from randomized participants in moxifloxacin and placebo arms, who had evaluable time-matched ECG assessments in both periods (Day -1/1 or Day 11/12) in placebo and moxifloxacin on Days -1, 1, 11, and 12.||participants|||Number
692846|NCT01423916|Secondary|Number of Participants With QTcI Interval > 60 Msec on Day 11.|The primary QT to QTc correction formula (QTcI) were determined for each participant using the participant's Baseline (Day -1 placebo) ECG data. The QT correction formula QT / (RR)k were derived using log-log-linear regression, where log (QT) = a + k × log (RR) + ε to estimate the exponent (k). Participants with QTcI interval change of > 60 msec on Day 11 were presented here.|Day 11|Assay sensitivity dataset demonstrated the effect of moxifloxacin on QTcI from randomized participants in moxifloxacin and placebo arms who had evaluable time-matched ECG assessments on Days -1, 1, 11, and 12. Number of participants analyzed included those who had observations in QTc at both Days −1 and 11.||participants|||Number
692847|NCT01423916|Secondary|Number of Participants With QTcI Interval Between 30 and 60 Msec on Day 11.|The primary QT to QTc correction formula (QTcI) were determined for each participant using the participant's Baseline (Day -1 placebo) ECG data. The QT correction formula QT / (RR)k were derived using log-log-linear regression, where log (QT) = a + k × log (RR) + ε to estimate the exponent (k). Participants with QTcI interval change between 30 to 60 msec were presented here.|Day 11|Assay sensitivity dataset shows the effect of moxifloxacin on QTcI from randomized participants in moxifloxacin and placebo arms who had evaluable time-matched ECG assessments on Days -1, 1, 11, and 12. Number of participants analyzed were total number of participants with both Baseline and at least one observation of the given parameter.||participants|||Number
692848|NCT01423916|Secondary|Change From Baseline in Summary of Maximum QTcI on Day 11 Minus Maximum QTcI on Day -1 (Baseline).|The primary QT to QTc correction formula (QTcI) were determined for each participant using the participant's Baseline (Day -1 placebo) ECG data. The QT correction formula QT / (RR)k were derived using log-log-linear regression, where log (QT) = a + k × log (RR) + ε to estimate the exponent (k). The change from Baseline in summary of maximum QTcI on Day 11 minus maximum QTcI on Day -1 (Baseline) is presented here.|Baseline, Day 11|Assay sensitivity dataset demonstrated the effect of moxifloxacin on QTcI from randomized participants in moxifloxacin and placebo arms who had evaluable time-matched ECG assessments on Days -1, 1, 11, and 12. Number of participants analyzed included those who had observations in QTc at both Days −1 and 11.||msec||Standard Deviation|Mean
692849|NCT01423916|Secondary|Change From Baseline in Summary of Maximum QTcI on Day 11 Minus Mean QTcI on Day -1 (Baseline).|The primary QT to QTc correction formula (QTcI) were determined for each participant using the participant's Baseline (Day -1 placebo) ECG data. The QT correction formula QT / (RR)k were derived using log-log-linear regression, where log (QT) = a + k × log (RR) + ε to estimate the exponent (k). The change form Baseline in summary of maximun QTcI on Day 11 minus mean QTcI on Day -1 (Baseline) is presented here.|Baseline, Day 11|Assay sensitivity dataset shows the effect of moxifloxacin on QTcI from randomized participants in moxifloxacin and placebo arms who had evaluable time-matched ECG assessments on Days -1, 1, 11, and 12. Number of participants analyzed were total number of participants with both Baseline and at least one observation of the given parameter.||msec||Standard Deviation|Mean
692850|NCT01423916|Secondary|Number of Participants Noted With Time-matched Change in Mean QTcI Change From Baseline for Assay Sensitivity of Moxifloxacin Treatment Corrected for Placebo at Day 11.|New onset (> 450, > 480, or > 500 msec) in QTc was defined as a participant who attained a QTc > 450, > 480, > 500 msec during Day 11 but not on Day −1. The number of participants were noted with time-matched change in mean QTcI change from Baseline for assay sensitivity of moxifloxacin treatment corrected for placebo. The primary QT to QTc correction formula (QTcI) were determined for each participant using the participant's Baseline (Day -1 placebo) ECG data. The QT correction formula QT / (RR)k were derived using log-log-linear regression, where log (QT) = a + k × log (RR) + ε to estimate the exponent (k).|Baseline, Day 11|Assay sensitivity dataset demonstrated the effect of moxifloxacin on QTcI from randomized participants in moxifloxacin and placebo arms who had evaluable time-matched ECG assessments on Days -1, 1, 11, and 12. Number of participants analyzed included those who had observations in QTc at both Days −1 and 11.||participants|||Number
692851|NCT01423916|Primary|Area Under the Plasma Concentration-time Curve During Dosing (AUCT).|Pharmacokinetics endpoint is the area under the concentration-time curve from time zero to 24 hours (AUC0-24h) of brexpiprazole and moxifloxacin. Area under the plasma concentration-time curve during the dosing interval at steady-state (AUCT) value was estimated using the linear trapezoidal rule; the value reported represent the area under the curves to the last time point during that day. Blood samples were collected on Days -1, 1, 11, and 12 at predose, and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose or at ET.|Day 11|PK analysis dataset consisted of all evaluable PK parameters from randomized participants who had plasma concentrations. For Moxifloxacin group, area under the plasma concentration-time curve was calculated to the last observable concentration.||ng*h/mL||Standard Deviation|Mean
692852|NCT01423916|Primary|Time to Maximum (Peak) Plasma Concentration (Tmax) of Brexpiprazole and Moxifloxacin.|Pharmacokinetics endpoint is the time to maximum (peak) plasma concentration (tmax) of brexpiprazole and moxifloxacin. Values for tmax were determined directly from the observed data. Blood samples were collected on Days -1, 1, 11, and 12 at predose, and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose or at ET.|Day 11|PK analysis dataset consisted of all evaluable PK parameters from randomized participants who had plasma concentrations.||Hours||Full Range|Median
692853|NCT01423916|Primary|Maximum Peak Plasma Concentration (Cmax) of Brexpiprazole and Moxifloxacin.|Pharmacokinetics endpoint is the maximum (peak) plasma concentration (Cmax) of brexpiprazole and moxifloxacin. Values for Cmax were determined directly from the observed data. Blood samples were collected on Days -1, 1, 11, and 12 at predose, and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose or at ET.|Day 11|Pharmacokinetics (PK) analysis dataset consisted of all evaluable PK parameters from randomized participants who had plasma concentrations.||ng/mL||Standard Deviation|Mean
692854|NCT01423916|Primary|Number of Participants With Adverse Events (AE) and Clinically Important Changes in Vital Signs, Physical Examinations, Laboratory Tests, and Standard ECGs (Electrocardiogram).|Clinically important changes in vital signs, physical examinations, laboratory tests and ECGs were by and large reflected in AE/SAE (which are presented in safety section) of this report.|AEs were recorded from Screening (informed consent was signed) during the 12-day treatment period to follow-up 30 (+ 2) days post-last dose of study medication|Safety dataset of randomized participants received 1 dose of study medication after Day 1.||participants|||Number
692855|NCT01423916|Primary|Time-matched QTcI Change From Baseline (Day −1) Corrected for Placebo on Day 11 Following Brexpiprazole Treatment.|Pharmacodynamics endpoint is the time-matched corrected QT interval (QTcI) change from baseline (Day -1) corrected for placebo on Day 11 following brexpiprazole treatment. The primary QT to QTc correction formula (QTcI) was determined for each participant using the participant's baseline (Day -1 placebo) ECG data. The QT correction formula QT / (RR)k was derived using log-log-linear regression, where log (QT) = a + k × log (RR) + ε to estimate the exponent (k).|Day 11 (Hours 1, 2, 3, 4, 5, 6, 8, 12, 16, 24)|The dataset quantitates effect of brexpiprazole on individual QTcI corrected for placebo of the completer population where participants received study medication from Day 1 to Day 11 (placebo at Day 1) had 1 Predose and Post-dose time-matched ECG assessments on Day 1 and Day 11. The first 5 time points for moxifloxacin arm only were 2-sided 98% CI.||msec||90% Confidence Interval|Mean
692856|NCT01423773|Primary|Final Comfort|"Comfort was assessed by the participant on a Visual Analog Scale of 0 to 100, where 0=Extremely Uncomfortable (My eyes are in pain. I cannot tolerate my lenses) and 100=Extremely Comfortable (My eyes feel GREAT, better than normal. I cannot feel my lenses)."|Day 2, Hour 10|All enrolled participants||Units on a scale||Standard Deviation|Mean
692857|NCT01423760|Secondary|Overall Survival (OS)|Overall survival time was defined as the time from randomization to death. Subjects without events were censored at the last date they were known to be alive.|From randomization to death, assessed up to 3.6 years|Efficacy analysis was not performed due to the premature termination of this safety follow-up study and the tecemotide program based on negative results in EMR 63325-009 (NCT00960115)|||||
692858|NCT01423760|Primary|Number of Subjects With Adverse Events (AEs), Serious AEs, AEs Leading to Discontinuation and AEs Leading to Death|An Adverse Event (AE) is defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A Serious AE is an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect, AEs leading to discontinuation and AEs leading to death.|Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years|Only subjects treated with tecemotide were included in the safety analysis set.||Subjects|||Number
692859|NCT01423604|Secondary|Summary of Clinical Benefit|"A subject was considered a clinical benefit responder if he/she met at least 1 of the following criteria:
Subject showed improvement in at least one of the following parameters on successive scheduled observations without worsening in the others: pain intensity, analgesic use, or performance status
Subject was stable or improved on the pain intensity, analgesic use, and performance status and had a ≥ 7% increase in body weight maintained for 2 consecutive reporting periods that was not because of fluid accumulation."|Measured every 4 weeks until death or PD, whichever was earlier (up to 8 months)|The intent-to-treat (ITT) population included subjects randomized in Part 2 of the study.||percentage of participants|||Number
692860|NCT01423604|Secondary|Durable Response Rate|Durable response was defined as subjects with a response of Partial response (PR) or better at 2 subsequent measurements that were at least 4 weeks apart.|Measured every 4 weeks until death or PD, whichever was earlier (up to 8 months)|The intent-to-treat (ITT) population included subjects randomized in Part 2 of the study.||percentage of participants|||Number
692861|NCT01423604|Secondary|Objective Response Rate|Objective response rate (ORR) was defined as the percentage of participants with either a confirmed complete response (CR) or partial response (PR) measured by the investigator per modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 criteria during the treatment period. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Measured every 4 weeks for duration of study treatment (up to 8 months)|The intent-to-treat (ITT) population included subjects randomized in Part 2 of the study.||percentage of participants|||Number
694454|NCT01401153|Primary|Tonic Alertness (Commission Errors)|Reactions when no stimulus had been presented|Participants were tested twice with one week wash out (1h after having/skipping lunch)|Complete case analysis||Commission errors||Inter-Quartile Range|Median
692862|NCT01423604|Secondary|Progression-Free Survival (PFS)|Progression-free survival was defined as the length of time between the date of randomization and the earlier of death or progressive disease (PD), whichever was earlier, as assessed by RECIST. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Analysis includes study data from the start of the study (first dose for that subject) until death or PD, whichever was earlier up to 8 months.|The intent-to-treat (ITT) population included subjects randomized in Part 2 of the study.||days||95% Confidence Interval|Median
692863|NCT01423604|Primary|Overall Survival|Overall survival was measured as the length of time (in days) between the randomization date and the date of death.|Primary analysis includes study data from the start of the study (first dose for that subject) until the death of the subject (up to 8 months).|The intent-to-treat (ITT) population included subjects randomized in Part 2 of the study.||days||95% Confidence Interval|Median
692872|NCT01423162|Primary|Percent Iron Absorption|Percentage of iron available for absorption from fortified oat drink with and without added vitamin C|14 days after administration|Per protocol||percentage of Iron absorbed||Standard Error|Mean
692873|NCT01423084|Secondary|Number of Subjects Reporting SAEs and AE Leading to Withdrawal|Number of subjects reporting any Serious AEs (SAEs), medically attended AEs and AEs that result in a subject’s withdrawal from the study after any vaccination.|Throughout the study period.|Safety Set||Number of subjects|||Number
692874|NCT01423084|Secondary|Number of Subjects Reporting Unsolicited AEs|Number of subjects reporting any Unsolicited AEs after any vaccination.|From day 1 to day 7 after any vaccination.|Safety Set||Number of subjects|||Number
692875|NCT01423084|Secondary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)|Number of subjects reporting solicited local and systemic Adverse Events and other indicators of reactogenicity after any vaccination.|From day 1 to day 7 after any vaccination|Safety Set||Number of subjects|||Number
692876|NCT01423084|Secondary|GMR of ELISA GMCs Against Antigen 287-953 at Day 45.|The immune response of two different lots of rMenB+OMV NZ against antigen 287-953 is evaluated in terms of GMRs between ELISA GMCs (day 45 vs baseline).|Two weeks after the second vaccination (day 45)|Per Protocol Set, immunogenicity subset||Ratio of GMTs||95% Confidence Interval|Geometric Mean
692877|NCT01423084|Primary|ELISA Geometric Mean Concentration (GMCs) Against Vaccine Antigen 287-953|The immune response of two different lots of rMenB+OMV NZ is evaluated in terms of ELISA GMCs against vaccine antigen 287-953.|One month after the second vaccination (day 61)|Per Protocol Set population||IU/ml||95% Confidence Interval|Geometric Mean
692878|NCT01423084|Secondary|ELISA GMCs Against Vaccine Antigen 287-953 at Day 45.|The immune response of two different lots of rMenB+OMV NZ is evaluated in terms of ELISA GMCs against vaccine antigen 287-953.|Two weeks after the second vaccination (day 45)|Per Protocol Set, immunogenicity subset.||IU/ml||95% Confidence Interval|Geometric Mean
703385|NCT00094900|Secondary|Mean Change in C-Reactive Protein||6 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||mg/dl||Standard Error|Mean
692879|NCT01423084|Secondary|Percentage of Subjects With hSBA ≥1:5 Against Each of N. Meningitidis Serogroup B Reference Strains at Day 45.|The immune response of two different lots of rMenB+OMV NZ against each of N. Meningitidis serogroup B reference strains is evaluated in terms of percentages of subjects with hSBA ≥1:5 two weeks after the last vaccination.|Two weeks after the second vaccination (day 45)|Per Protocol Population, immunogenicity subset||Percentage of subjects||95% Confidence Interval|Number
692880|NCT01423084|Secondary|GMRs of GMT Against 3 N. Meningitidis Serogroup B Reference Strains at Day 45.|"The immunogenicity of two different lots of rMenB+OMV NZ is evaluated in terms of GMRs of GMT against 3 N.
meningitidis serogroup B reference strains at two weeks after last vaccination."|Two weeks after the second vaccination (day 45)|Per Protocol Set, Immunogenicity subset||Ratio of GMTs||95% Confidence Interval|Geometric Mean
692881|NCT01423084|Secondary|hSBA GMT Against 3 N. Meningitidis Serogroup B Reference Strains at Day 45.|The immunogenicity of two different lots of rMenB+OMV NZ is evaluated in terms of hSBA GMT against 3 N. Meningitidis serogroup B reference strains at two weeks after last vaccination.|Two weeks after the second vaccination (day 45)|Per Protocol Set, immunogenicity subset||Titers||95% Confidence Interval|Geometric Mean
692882|NCT01423084|Secondary|Geometric Mean Ratio (GMR) of ELISA Geometric Mean Concentration (GMCs) Against Antigen 287-953|The immune response of two different lots of rMenB+OMV NZ against antigen 287-953 is evaluated in terms of GMRs between ELISA GMCs (day 61 vs baseline).|One month after the second vaccination (day 61)|Per Protocol Set Population||Ratio of GMTs||95% Confidence Interval|Geometric Mean
692883|NCT01423084|Secondary|Geometric Mean Ratio (GMR) of GMTs Against Each of N. Meningitidis Serogroup B Reference Strains.|The immune response of two different lots of rMenB+OMV NZ against each of N. meningitidis serogroup B test strains is evaluated in terms of GMR between GMTs (1month after the second vaccination vs baseline).|One month after the second vaccination (day 61)|Per Protocol Set Population||Ratio of GMTs||95% Confidence Interval|Geometric Mean
692884|NCT01423084|Secondary|Percentage of Subjects in Each Lot With hSBA ≥ 1:5|The percentage of subjects in each lot with hSBA ≥ 1:5 at one month after the second vaccination for each of the three reference strains (H44/76, 5/99, and NZ98/254) for each vaccine group|One month after the second vaccination (day 61)|Per Protocol Set population||Percentage of subjects||95% Confidence Interval|Number
692885|NCT01423084|Primary|Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against 3 Neisseria.Meningitidis (N. Meningitidis) Serogroup B Reference Strains.|Consistency of the immune response of the two lots of rMenB+OMV NZ will be assessed at one month after the second vaccination based on the ratio of the vaccine lot hSBA GMTs for each of three serogroup B reference strains (H44/76, 5/99, and NZ98/254) and based on the ratio of Enzyme-linked Immunosorbent Assay (ELISA) GMCs for vaccine antigen 287-953. The equivalence interval will be (0.5, 2.0).|One month after the second vaccination (day 61)|Per Protocol Set population||Titers||95% Confidence Interval|Geometric Mean
692886|NCT01422915|Primary|Protoporphyrin Concentration in Blood|"erythrocyte protoporphyrin concentration, ug/dl
plasma protoporphyrin concentration, ug/dl"|Samples collected while on treatment (range 93-208 treatment days)|||ug/dl||Standard Deviation|Mean
692887|NCT01422915|Primary|Photosensitivity, Assessed by Measuring the Number of Minutes of Sun Tolerance|Minutes of sun tolerance|At 60 days of treatment|All of the original 4 subjects had bona fide erythropoietic protoporphyria (EPP). One subject was removed during Perdiod 1. The data from the same 3 subjects who completed periods 1 and 2 were analyzed for the study results. Data collected was not tractable for statistical analysis given the range of results||minutes||Standard Deviation|Mean
692888|NCT01422889|Secondary|Stent Thrombosis|Academic Research Consortium (ARC) defined (definite/probable) stent thrombosis (ST) in the ION registry population. For the protocol specified secondary endpoint analysis including data pooled from the PERSEUS SV, PERSEUS WH and TE Prove patient populations please see the citations.|Annually, after the first year, through 2 years.|There were 57 subjects not evaluable for 2-year cardiac events (No follow-up ≥ 700 days and events-free within 730-day) leaving a total of 1054 subjects evaluated for ARC ST Definite/Probable.||percentage of participants|||Number
692889|NCT01422889|Primary|Cardiac Death or Myocardial Infarction (CD/MI)|Cardiac Death or myocardial infarction (CD/MI) in the ION registry population. For the protocol specified primary endpoint analysis including data pooled from the PERSEUS SV, PERSEUS WH and TE Prove patient populations please see the citations.|12 Months|There were 83 subjects not evaluable for 12-month cardiac events (No follow-up ≥ 335 days and events-free within 365-day) leaving a total of 1028 subjects evaluated for 12 month CD/MI.||percentage of paricipants|||Number
692890|NCT01422876|Secondary|Occurrence of Treat to Target Efficacy Response for Treatment Naive Patients|Occurrence of the treat-to-target efficacy response for Treatment Naive patients measured as HbA1c < 7.0% after 24 weeks of treatment for patients with HbA1c >=7.0% at baseline.|24 Weeks|Full Analysis Set (FAS) with non-completers considered failures (NCF). FAS-treatment naive patients randomised and treated who had a baseline (HbA1c>= 7% at baseline are included) and at least 1 on treatment HbA1c value with NCF approach, in which missing data due to premature discontinuation of a patient were considered as failure.||% of patients satisfying HbA1c <7.0%||95% Confidence Interval|Number
692891|NCT01422876|Secondary|Occurrence of Treat to Target Efficacy Response for Metformin Background Patients|Occurrence of the treat-to-target efficacy response for Metformin Background patients measured as HbA1c < 7.0% after 24 weeks of treatment for patients with HbA1c >=7.0% at baseline.|24 Weeks|Full Analysis Set (FAS) with non-completers considered failures (NCF). FAS- Metformin background patients randomised and treated who had a baseline (HbA1c>= 7% at baseline are included) and at least 1 on treatment HbA1c value with NCF approach, in which missing data due to premature discontinuation of a patient were considered as failure.||% of patients satisfying HbA1c <7.0%||95% Confidence Interval|Number
692892|NCT01422876|Secondary|Change From Baseline in Body Weight for Treatment Naive Patients|Change from baseline in body weight for Treatment Naive patients.|Baseline and 24 Weeks|Full Analysis Set (FAS) with last observation carried forward (LOCF). FAS - all treatment naive patients randomised and treated who had a baseline and at least 1 on treatment HbA1c value.||kg change from baseline||Standard Error|Least Squares Mean
692998|NCT01421667|Secondary|Progression-Free Survival With Brentuximab Vedotin Monotherapy by Kaplan-Meier Analysis|Progression-free survival, defined as time from start of study treatment to disease progression per investigator or death due to any cause|Up to approximately 3 years|All participants who received treatment with brentuximab vedotin monotherapy and had both a baseline and at least one post-baseline disease assessment.||months||Full Range|Median
692893|NCT01422876|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) for Treatment Naive Patients|Glycosylated hemoglobin (HbA1c) is a measurement of the percentage of hemoglobin that is glycated. The change from baseline in HbA1c is calculated as the week 24 HbA1c minus the baseline HbA1c. Since HbA1c is measured as a percentage the change from baseline is also a percentage.|Baseline and 24 weeks|Full Analysis Set (FAS) with last observation carried forward (LOCF). FAS - all treatment naive patients randomised to and treated who had a baseline and at least 1 on treatment HbA1c value.||% change from baseline||Standard Error|Least Squares Mean
692894|NCT01422876|Secondary|Change From Baseline in Body Weight for Metformin Background Patients|Change from baseline in body weight for Metformin Background patients.|Baseline and 24 Weeks|Full Analysis Set (FAS) with last observation carried forward (LOCF). FAS - all Metformin Background patients randomised and treated who had a baseline and at least 1 on treatment HbA1c value.||kg change from baseline||Standard Error|Least Squares Mean
692895|NCT01422876|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 24 for Treatment Naive Patients|Change from baseline in fasting plasma glucose at week 24 for Treatment Naive patients.|Baseline and 24 Weeks|Full Analysis Set (FAS) with last observation carried forward (LOCF). FAS - all treatment naive patients randomised and treated who had a baseline and at least 1 on treatment HbA1c value.||mg/dL change from baseline||Standard Error|Least Squares Mean
692896|NCT01422876|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 24 for Metformin Background Patients|Change from baseline in fasting plasma glucose at week 24 for Metformin Background patients.|Baseline and 24 Weeks|Full Analysis Set (FAS) with last observation carried forward (LOCF). FAS - all Metformin Background patients randomised and treated who had a baseline and at least 1 on treatment HbA1c value.||mg/dL change from baseline||Standard Error|Least Squares Mean
692897|NCT01422876|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) for Metformin Background Patients|Glycosylated hemoglobin (HbA1c) is a measurement of the percentage of hemoglobin that is glycated. The change from baseline in HbA1c is calculated as the week 24 HbA1c minus the baseline HbA1c. Since HbA1c is measured as a percentage the change from baseline is also a percentage.|Baseline and 24 weeks|Full Analysis Set (FAS) with last observation carried forward (LOCF). FAS - all Metformin Background patients randomised and treated who had a baseline and at least 1 on treatment HbA1c value.||% change from baseline||Standard Error|Least Squares Mean
692898|NCT01422850|Primary|Blood Pressure, Pulse and Temperature|Blood pressure, pulse and temperature were monitored frequently during 48 hours post injection of the study product, and thereafter at each follow up visit.|At planned study visit´s at study week 0, 4, 5, 6, 7, 9, 10, 11, 12, 14, 15, 16, 18, 21, 24 and at study visit week 25|||participants|||Number
692899|NCT01422850|Secondary|The Secondary Endpoint for This Study is to Establish if Any Indications of a Positive Therapeutic Effect on the Prostate Cancer May be Observed.|No significant conclusion of efficacy is possible due to the study design with only one group of patients. However by analyzing and comparing the outcome with the data the individual patient presented at baseline some trends of efficacy, defined as stable disease or partial response, are possible. Trends towards possible treatment response were measured by monitoring PSA, a potential marker for prostate cancer disease progression; by other blood markers; and by Quality of life questionnaire (EORTC QLQ-C30) and WHO/ECOG (Eastern Cooperative Oncology Group). Control of any bone metastases were followed by hotspots and bone scan index measured by skeletal scintigraphy.|Within 12 weeks|||participants|||Number
692900|NCT01422850|Primary|Adverse Events|"To show safety and tolerability patients was monitored closely after administration of ALECSAT and during the follow up period. Heart rate, temperature, blood pressure, Performance status was monitored. Blood samples analysed were: PSA, Alkaline Phosphatase (ALP), Lactate DeHydogenase (LDH), Creatinine (CREAT) and Standard haematology: Blood picture (complete blood count, haemogram), leucocytes, Differential count, electrolytes, renal function, and liver count (liver enzymes).
AE and SAE was reported during the study period and the Investigator was urged to judge whether the event was related to the study product or not."|At planned study visit´s at study week 0, 4, 5, 6, 7, 9, 10, 11, 12, 14, 15, 16, 18, 21, 24 and at study visit week 25|No formal statistical analysis plan was considered for this study. Any subject that received one administration of ALECSAT and a 6 week follow-up period will be considered as having received ALECSAT and be included in the efficacy part of the report. All patients that received at least one injection of ALECSAT was assessed for safety.||Events|||Number
692901|NCT01422824|Secondary|Hemoglobin Levels||Baseline; Weeks 8, 16, 24, 48|Efficacy intent-to-treat population included all treated participants. Here, 'n' signifies the number of participants with available data for hemoglobin at specified visits.||gram per liter||Standard Deviation|Mean
692902|NCT01422824|Primary|Number of Participants With Adverse Events (AEs)|AE: any unfavorable and unintended sign, symptom, or disease associated with use of study drug, regardless of relation to study drug. Pre-existing conditions that worsened and laboratory or clinical tests that resulted in change in treatment or discontinuation from study drug were reported as AEs. Serious AE (SAE): resulted in death, life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was congenital anomaly/birth defect, or was medically significant. Any AE included participants with both serious and non-serious AEs.|Up to 12 months|Safety population||participants|||Number
692903|NCT01422720|Secondary|Change From Baseline in Standardized Seizure Frequency|Absolute and relative changes from baseline of seizure frequency standardised to a frequency per 4 weeks.|8-week Baseline Period and 26-week Treatment Period|||seizures/4 weeks||Standard Deviation|Mean
692904|NCT01422720|Primary|Number of Subjects With Reported Adverse Events (AE)|"An AE was defined as Treatment-Emergent Adverse Event (TEAE), if first onset or worsening was after the first intake of investigational medicinal product (IMP) and not more than 14 days after the last administration of IMP.
TEAE assessment:
patients who died
patients who died due to Treatment-emergent adverse event (TEAE)
patients with at least one Serious Adverse Event (SAE)
patients with at least one Treatment-emergent Serious Adverse Event (TESAE)
patients prematurely terminated due to TEAE
patients with at least one TEAE
patients with at least one related TEAE
patients with at least one severe TEAE
patients without any TEAE"|throughout the study|||participants|||Number
693016|NCT01421511|Secondary|Change From Baseline in Patient-reported Pain, by Study Visit|0=no pain, 10=worst pain Only 1 visit per participant for Day 4-6, only 1 visit for Day 7-9, and only 1 visit for Day 10-13.|Multiple|The Intent to Treat analysis set includes data from all randomized participants.||units on a scale||Standard Deviation|Mean
692905|NCT01422538|Secondary|Subject Satisfaction at 180 Days Post-treatment|Subjects rated their satisfaction as Very Satisfied, Satisfied, Dissatisfied or Very Dissatisfied using a Patient Satisfaction Questionnaire (PSQ). Responses at 180 days post-treatment Responses were tabulated.|180 days post-treatment|Data analyzed includes PSQ responses at 180 days post-treatment assessing subjects' satisfaction with study treatment. Responses were tabulated. Outcomes reported represent the percentage of subjects reporting any satisfaction, i.e., Very Satisfied and Satisfied.||percentage of participants Satisfied|||Number
692906|NCT01422538|Secondary|Subject Satisfaction at 90 Days Post-treatment|Subjects rated their satisfaction as Very Satisfied, Satisfied, Dissatisfied or Very Dissatisfied using a Patient Satisfaction Questionnaire (PSQ). Responses at 90 days post-treatment Responses were tabulated.|90 days post-treatment.|Data analyzed includes PSQ responses at 90 days post-treatment assessing subjects' satisfaction with study treatment. Responses were tabulated. Outcomes reported represent the percentage of subjects reporting any satisfaction, i.e., Very Satisfied or Satisfied.||percentage of participants Satisfied|||Number
692907|NCT01422538|Other Pre-specified|Subject's Assessment of Pain|Subjects' sensory response to the Ulthera treatment exposures were recorded for each anatomical region treated using a validated Numeric Rating Scale (0-10), with 1 representing no pain and 10 representing the worst pain possible. Pain assessment data were obtained from Group A and Group C subjects only.|During Ulthera study treatment|||units on a scale||Full Range|Mean
692908|NCT01422538|Secondary|Overall Aesthetic Improvement at 180 Days Post-treatment|"At 180 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS) (Physician GAIS - PGAIS; Subject GAIS - SGAIS), comparing to pre-treatment photos. The GAIS is 5-point scale (1-5) describing an overall assessment as follows:
= Very Much Improved
= Much Improved
= Improved
= No Change
= Worse Any Improvement includes subjects assessed in categories 1-3."|180 days post-treatment|||percentage of participants improved|||Number
692909|NCT01422538|Secondary|Overall Aesthetic Improvement at 90 Days Post-treatment|"At 90 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS) (Physician GAIS - PGAIS; Subject GAIS - SGAIS), comparing to pre-treatment photos. The GAIS is 5-point scale (1-5) describing an overall assessment as follows:
= Very Much Improved
= Much Improved
= Improved
= No Change
= Worse Any Improvement includes subjects assessed in categories 1-3."|90 days post-treatment.|||percentage of participants improved|||Number
692910|NCT01422538|Primary|Lifting and Tightening of Skin as Determined by Masked Assessment of Pre- and Post-treatment Photographs.|Three masked assessors reviewed pre- and 90 days post-treatment photos from 29 subjects who returned for their 90-day follow-up visit, assessing for improvement in skin laxity at 90 days post-treatment compared to baseline, i.e., lifted and tightened skin in the areas treated with the assigned study treatment based on the assigned study arm.|90 days post-treatment|||percentage of participants improved|||Number
692911|NCT01422434|Secondary|Change in mPASI From Baseline to Week 1|The extent of and severity of redness, thickness and scaliness of psoriasis were recorded for each of three regions (arms, trunk and legs) and these were used to calculate mPASI. The m-PASI could range from 0 to 64.8. The least severe outcome is 0 and the most severe outcome is 64.8|Baseline to Week 1|||percentage of change||Standard Deviation|Mean
692912|NCT01422434|Secondary|Physician's Global Assessment of Psoriasis|"Subjects with ‘clear’ or ‘almost clear’ disease by physician’s global assessment on the following 6 point scale: clear, almost clear, mild, moderate, severe, very severe.
The assessment represents the average lesion severity on the trunk and limbs. The assessment was based on the condition of the disease at the time of evaluation, and not in relation to the condition at a previous visit."|Week 4|||participants|||Number
692913|NCT01422434|Secondary|Change From Baseline in Target Lesion Assessment|"Percentage change in composite severity score of the target lesion from baseline to Week 4.
At Visit 1, the investigator selected a target lesion. Location was recorded as trunk, limb excluding elbow and/or knee.
At Visits 1-4, the investigator assessed the severity of the target lesion for each sign (redness, thickness and scaliness) on a scale from 0 to 8 where 0 is no signs of redness, thickness or scaliness and 8 is the most severe signs of redness, thickeness or scaliniess.
The individual scores for redness, thickness and scaliness were added together to give a single composite score for severity of the target lesion which could range from 0 to 24. The percentage change in the composite severity score from baseline to each visit was also calcutated."|Baseline to Week 4|||percentage of change||Standard Deviation|Mean
692914|NCT01422434|Primary|Change From Baseline in Modified Psoriasis Area and Severity Index (mPASI)|"The primary response criterion was the percentage change in m-PASI from baseline to Week 4.
The extent of and severity of redness, thickness and scaliness of psoriasis were recorded for each of three regions (arms, trunk and legs) and these were used to calculate mPASI using the following formula:
Arms: 0.2(R+T+S)E = X Trunk: 0.2(R+T+S)E = Y Legs: 0.2(R+T+S)E = Z where R = score for redness (using a scale from 0 to 4, where o is non signs and 4 is the most severe signs) T = score for thickness (using a scale from 0 to 4, where o is non signs and 4 is the most severe signs) S = score for scaliness (using a scale from 0 to 4, where o is non signs and 4 is the most severe signs) E = score for extent (using a scale from 0 to 6, where 0 is no involvement and 6 is 90-100% involvemnet) The sum of X + Y + Z gave the total m-PASI, which could range from 0 to 64.8."|Baseline to Week 4|||percentage of change||Standard Deviation|Mean
699287|NCT00002540|Secondary|T1 DRE Screening Results|Digital Rectal Examination (DRE) result.|T1 (one year after entry)|All males in the Prostate Screening arm who had a DRE screen at T1 were analyzed.||Participants|||Number
693017|NCT01421511|Secondary|Investigator's Assessment of Clinical Response at the Day-7 Visit|Clinical improvement defined as improvement in overall clinical status.|Day 7|The Intent to Treat analysis set includes data from all randomized participants.||participants|||Number
693018|NCT01421511|Secondary|Investigator's Assessment of Clinical Response at the 48-72 Hour Visit|Clinical improvement defined as improvement in overall clinical status.|48-72 Hours|The Intent to Treat analysis set includes data from all randomized participants.||participants|||Number
693110|NCT01420081|Secondary|Maximum Plasma Concentration (Cmax) of PF-05212384 at Each Specified Time Points.||Pre-dose: 0 hours, and Post dose: 0.5 (after end of infusion), 1, 2, 4, 6, 24, 72, and 120 hours at Day 1|Participants were analyzed on PK parameter analysis set which was defined as all treated patients who had at least one of the PK parameters of interest estimated.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
692941|NCT01422382|Secondary|Number of Participants With at Least One Adverse Event.||24 Days|||Participants|||Number
692942|NCT01422382|Primary|NK-104 AUC||15 Days|All subjects with measurable pharmacokinetic (PK) values||ng * h/mL||Standard Deviation|Mean
692943|NCT01422369|Secondary|Number of Participants With at Least One Adverse Event.||16 Days|All subjects who took at least one dose of study medication.||Participants|||Number
692944|NCT01422369|Primary|NK-104 AUC||16 Days|All subjects with measurable pharmacokinetic (PK) values.||ng * h/mL||Standard Deviation|Mean
692945|NCT01422356|Primary|HPV Prevalence|Prevalence of anal HPV of any type at baseline|Baseline|Number of men at baseline visit||participants|||Number
693143|NCT01419769|Primary|Safety - Freedom From Major Complications: Stent Migration/Dislodement|Treated subjects are free of stent migration/ dislodgement into the pseudocyst or enteral lumen|Through the duration of the 1-week post-stent removal study period|Per protocol population of subjects with stent successfully placed||percentage of patients|||Number
692946|NCT01422304|Other Pre-specified|Number of Participants With One or More Postoperative Anemia Adverse Events With Onset Within 72 Hours After Study Drug Administration|This measure is the incidence of postoperative anaemia with an onset within 72 hours after study drug administration. A participant is included in the count for this measure if an adverse event with any of the following event terms occurred in the participant with onset within the defined time frame: postoperative anaemia, anaemia, haemorrhagic anaemia, haemoglobin decreased or haemoglobin S decreased.|Up to 72 hours post study drug administration|APaT population||participants|||Number
692947|NCT01422304|Other Pre-specified|Postoperative Changes in Hgb Concentrations Using the Bleeding Index|The Bleeding Index was used to describe postoperative changes in Hgb concentrations at Visit 3. Bleeding Index = Hgb level at Visit 3 – Hgb level at baseline, adjusted for the amount of RBCs transfused. Missing baseline Hgb values were imputed using the overall mean Hgb value at baseline.|Baseline and Visit 3 (24-48 hours post study drug administration)|APaT population||g/L||Standard Deviation|Mean
692948|NCT01422304|Other Pre-specified|Total Transfusion Volume in Participants Who Required Postoperative Transfusion|Among participants who received a transfusion unit (e.g., whole blood, packed RBCs, cell saver RBCs, fresh frozen plasma, platelets) that started after study drug administration and within 120 hours after study drug administration (or within 48 hours after any previous [i.e., predose] transfusion for participants who had received a previous transfusion), the total volume of blood transfused post study drug was calculated. The volume of blood transfused post study drug (using linear interpolation when transfusions were ongoing at the time of study drug administration) was converted to grams of Hgb transfused, using RBC concentration information received from the investigators. The sum of Hgb transfused was standardized to “normal” volume Hgb in homologous whole blood, using 20 g/dL Hgb for calculation of the standardized volume.|From end of study drug administration through approximately 120 hours after study drug administration|Participants in APaT population who received a transfusion unit that started after study drug administration and within 120 hours after study drug administration (or within 48 hours after any previous [i.e., predose] transfusion for participants who had received a previous transfusion)||mL||Geometric Coefficient of Variation|Geometric Mean
692949|NCT01422304|Other Pre-specified|Number of Participants Requiring Any Postoperative Transfusion|The number of participants who received a transfusion unit (e.g., whole blood, packed RBCs, cell saver RBCs, fresh frozen plasma, platelets) that started after study drug administration and within 120 hours after study drug administration (or within 48 hours after any previous [i.e., predose] transfusion for participants who had received a previous transfusion) was determined.|From end of study drug administration through approximately 120 hours after study drug administration|APaT population||participants|||Number
692950|NCT01422304|Other Pre-specified|Postoperative Drainage Volume Within 24 Hours After Study Drug Administration|The total volume of postoperative drainage from the surgical site over the 24 hours after study drug administration was recorded.|Up to 24 hours post study drug administration|APaT population||mL||Standard Deviation|Mean
692951|NCT01422304|Secondary|Number of Participants With One or More Adjudicated Events of Anaphylaxis With Onset Within 14 Days After Study Drug Administration|This Measure is identified in study protocol as an Other Secondary Outcome Measure. Anaphylaxis is a serious allergic reaction that is rapid in onset and may cause death. Adverse events suggestive of hypersensitivity which met defined criteria (e.g., serious event) and/or suspected events of anaphylaxis were evaluated by a blinded external Adjudication Committee to determine whether such events met either of the following two criteria for anaphylaxis (Sampson et al. J Allergy Clin Immunol 2006;117:391-7) - 1. Acute onset of an illness with involvement of the skin, mucosal tissue or both, and at least one of the following: a) respiratory compromise, b) reduced blood pressure (BP) or associated symptoms of end-organ dysfunction. 2. Two or more of the following that occur rapidly after exposure to a likely allergen for that participant: a) involvement of the skin-mucosal tissue, b) respiratory compromise, c) reduced BP or associated symptoms, d) persistent gastrointestinal symptoms.|Up to 14 days post study drug administration|APaT population||participants|||Number
692952|NCT01422304|Secondary|Number of Participants With One or More Adjudicated Venous Thromboembolic (VTE) Events With Onset Within 14 Days After Study Drug Administration|This Measure is identified in study protocol as an Other Secondary Outcome Measure. Suspected symptomatic VTE events were evaluated by a blinded external Adjudication Committee. The confirmation of a VTE event was based on determination of a clinically meaningful venous thrombosis (e.g., pulmonary embolism or deep vein thrombosis).|Up to 14 days post study drug administration|APaT population||participants|||Number
692953|NCT01422304|Secondary|Number of Participants With One or More Adjudicated Major Events of Bleeding With Onset Within 14 Days After Study Drug Administration|This Measure is identified in study protocol as an Other Secondary Outcome Measure. All SUAEB were evaluated by a blinded external Adjudication Committee. MBE = one or more of the following: 1) Fatal bleeding; 2) Bleeding that is symptomatic and occurs in critical area/organ, in a non-operated joint, or is intramuscular with compartment syndrome; 3) Extrasurgical site bleeding causing a fall in Hgb level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or RBCs, occurring within 24 hours of the bleeding; 4) Surgical site bleeding requiring second intervention, or bleeding at operated joint that interferes with rehabilitation; or 5) Surgical site bleeding that is unexpected/prolonged and/or causes hemodynamic instability, with fall in Hgb level of at least 20 g/L (1.24 mmol/L) or transfusion of at least two units of whole blood or RBCs, occurring within 24 hours of the bleeding.|Up to 14 days post study drug administration|APaT population||participants|||Number
692954|NCT01422304|Secondary|Number of Participants With One or More Adjudicated Major Events of Bleeding With Onset Within 24 Hours After Study Drug Administration|This Measure is identified in study protocol as an Other Secondary Outcome Measure. All SUAEB were evaluated by a blinded external Adjudication Committee. Major bleeding event (MBE) = one or more of the following: 1) Fatal bleeding; 2) Bleeding that is symptomatic and occurs in critical area/organ, in a non-operated joint, or is intramuscular with compartment syndrome; 3) Extrasurgical site bleeding causing a fall in hemoglobin (Hgb) level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red blood cells (RBCs), occurring within 24 hours of the bleeding; 4) Surgical site bleeding requiring second intervention, or bleeding at operated joint that interferes with rehabilitation; or 5) Surgical site bleeding that is unexpected/prolonged and/or causes hemodynamic instability, with fall in Hgb level of at least 20 g/L (1.24 mmol/L) or transfusion of at least two units of whole blood or RBCs, occurring within 24 hours of the bleeding.|Up to 24 hours post study drug administration|APaT population||participants|||Number
692955|NCT01422304|Secondary|Number of Participants With One or More Adjudicated Events of Bleeding (Major or Non-major) With Onset Within 14 Days After Study Drug Administration|"This Measure is identified in study protocol as an Other Secondary Outcome Measure. Post-treatment events of bleeding were evaluated by a medically-qualified, blinded member of the surgical team (Blinded Safety Assessor), in consultation with the surgeon, to determine if an event was a suspected, unanticipated adverse event of bleeding (SUAEB). A SUAEB is an event of bleeding outside the usual boundaries of expectations for a participant considering the type of procedure as well as participant’s specific surgical experience and underlying risk of bleeding. In addition, blinded review of clinical and laboratory databases was performed to identify any event potentially consistent with a SUAEB; these were reviewed by the Blinded Safety Assessor, who determined if any was a SUAEB. All SUAEBs were evaluated by a blinded external Adjudication Committee, which classified each as either: 1) a major bleeding event, 2) a non-major bleeding event, or 3) not an unanticipated event of bleeding."|Up to 14 days post study drug administration|APaT population||participants|||Number
692956|NCT01422304|Secondary|Percent Change From Baseline in Prothrombin Time (International Normalized Ratio) (PT[INR]) at 10 and 60 Minutes Post Study Drug Administration|Change from baseline in PT(INR) is identified in study protocol as an Other Secondary Outcome Measure. Blood samples for determination of PT(INR) values were obtained at baseline and at 10 and 60 minutes after study drug administration. PT(INR) is a performance indicator measuring the efficacy of the extrinsic and common blood coagulation (blood clotting) pathways. The INR is the ratio of a participant's prothrombin time to a normal (control) sample, raised to the power of the International Sensitivity Index (ISI) value for the analytical system used (INR = [PT-Test/PT-Normal]^ISI). Higher values of PT(INR) indicate a reduction in the clotting tendency of blood.|Baseline, 10 and 60 minutes post study drug administration|Participants in APaT population who had baseline and at least one post baseline PT(INR) measurement within defined assessment window (10 or 60 minutes post study drug).||percent change||Standard Deviation|Mean
692957|NCT01422304|Secondary|Percent Change From Baseline in Activated Partial Thromboplastin Time (aPTT) at 10 and 60 Minutes Post Study Drug Administration|Change from baseline in aPTT is identified in study protocol as the Key Secondary Outcome Measure. Blood samples for determination of aPTT values were obtained at baseline and at 10 and 60 minutes after study drug administration. aPTT is a performance indicator measuring the efficacy of the intrinsic and common blood coagulation (blood clotting) pathways. Higher values of aPTT indicate a reduction in the clotting tendency of blood.|Baseline, 10 and 60 minutes post study drug administration|Participants in APaT population who had baseline and at least one post baseline aPTT measurement within defined assessment window (10 or 60 minutes post study drug).||percent change||Standard Deviation|Mean
692958|NCT01422304|Primary|Number of Participants With One or More Adjudicated Events of Bleeding (Major or Non-major) With Onset Within 24 Hours After Study Drug Administration|"Post-treatment events of bleeding were evaluated by a medically-qualified, blinded member of the surgical team (Blinded Safety Assessor), in consultation with the surgeon, to determine if an event was a suspected, unanticipated adverse event of bleeding (SUAEB). A SUAEB is an event of bleeding outside the usual boundaries of expectations for a participant (e.g., in amount of blood lost, prolonged duration of bleeding, or other factors) considering the type of procedure as well as participant’s specific surgical experience and underlying risk of bleeding. In addition, blinded review of clinical and laboratory databases was performed to identify any event potentially consistent with a SUAEB; these were reviewed by the Blinded Safety Assessor, who determined if any was a SUAEB. All SUAEBs were evaluated by a blinded external Adjudication Committee, which classified each as either: 1) a major bleeding event, 2) a non-major bleeding event, or 3) not an unanticipated event of bleeding."|Up to 24 hours post study drug administration|APaT population||participants|||Number
692959|NCT01422239|Secondary|Change in Smoking From Baseline to the Followup Assessment (Week 12)|Change in number of cigarettes per day (CPD) (averaged over the previous week) from the baseline assessment (Week 0) to the followup assessment (Week 12) for participants who did not quit smoking during the study.|Week 0 (baseline), Week 12 (one month followup)|Participants who completed the week 8 appointment and provided the number of cigarettes smoked per day were included.||CPD||Standard Deviation|Mean
692960|NCT01422239|Secondary|Point-prevalence Smoking Abstinence Four Weeks After the End of the Trial Assessed by Self-report and Carbon Monoxide Levels|point-prevalence smoking abstinence assessed at one month after the completion of counseling and measured by self-report (no smoking reported in the previous 7 days) and confirmed by carbon monoxide levels (CO levels < 5ppm)|12 weeks|participants who did not complete the appointment were considered to be smoking||participants|||Number
692961|NCT01422239|Primary|Point-prevalence Smoking Abstinence Assessed at the End of the Trial and Measured by Self-report and Confirmed by Carbon Monoxide Levels|point-prevalence smoking abstinence assessed at the end of the trial and measured by self-report (no smoking reported in the previous 7 days) and confirmed by carbon monoxide levels (CO levels < 5ppm)|Up to 8 weeks|Participants who dropped out of the study were considered to be smoking.||participants|||Number
692962|NCT01422226|Primary|Ease of IUD Insertion (Use of Ancillary Measures)|The primary outcome is the proportion in each group able to have the IUD inserted in a standard fashion without the ancillary measures of mechanical dilation of the cervix, placement of paracervical nerve block, or using abdominal ultrasound for guidance. The null hypothesis for the primary outcome is that misoprostol does not influence difficulty of insertion.|During the IUD insertion procedure, up to 2 hours|||participants|||Number
692963|NCT01422213|Secondary|Risk of Suicidality Using C-SSRS Scores|"The Columbia-Suicide Severity Rating Scale (C-SSRS) was developed by researchers at Columbia University as a tool to systematically assess suicidal ideation and behaviour in patients during participation in a clinical study. The C-SSRS is composed of questions that address suicidal behaviour and questions that address suicidal ideation, with subquestions that assess severity. The tool was administered via an interview with the patient.
For 2 patients in each treament group (6 in total) the CSSRS assessments are missing during study."|Up to 8 weeks|APTS||participants|||Number
692978|NCT01422213|Secondary|Change From Baseline to Week 8 in RAVLT (Acquisition)|Rey Auditory Verbal Learning Task (RAVLT) is a cognitive test designed to assess verbal learning and memory, including immediate memory, efficiency of learning, retroactive and proactive interference effects, and encoding versus retrieval. It consists of a number of tasks, including immediate recall and delayed recall. The number of words correctly recalled on each task is recorded.|Baseline and Week 8|FAS||number of words correctly recalled||Standard Error|Mean
692964|NCT01422213|Secondary|Change From Baseline to Week 8 Using the MADRS Total Score and the Composite Z-score|"Effect on cognitive dysfunction after correcting for the effect on depressive symptoms.
The estimation of the effect on cognitive dysfunction after correcting for the effect on depressive symptoms was based on the composite z-score and the MADRS total score. The effect was estimated in an ANCOVA model using the composite z-score at week 1 as dependent variable and the change from baseline to week 1 in the MADRS total score, the baseline MADRS total score, the baseline composite z-score, the treatment group and site as independent variables."|Baseline and Week 8|FAS, LOCF||z score||Standard Error|Least Squares Mean
692965|NCT01422213|Secondary|Change From Baseline to Week 1 Using the MADRS Total Score and the Composite Z-score|"Effect on cognitive dysfunction after correcting for the effect on depressive symptoms.
The estimation of the effect on cognitive dysfunction after correcting for the effect on depressive symptoms was based on the composite z-score and the MADRS total score. The effect was estimated in an ANCOVA model using the composite z-score at week 1 as dependent variable and the change from baseline to week 1 in the MADRS total score, the baseline MADRS total score, the baseline composite z-score, the treatment group and site as independent variables.
In the week 1 analysis the vortioxetine 10 and 20 mg groups were pooled because patients randomized to vortioxetine 20 mg received vortioxetine 10 mg in the first week of the study."|Baseline and Week 1|FAS, LOCF||z score||Standard Error|Least Squares Mean
692966|NCT01422213|Secondary|Proportion of Remitters at Week 8 (Remission is Defined as a MADRS Total Score <=10)||Week 8|FAS, LOCF||percentage of participants|||Number
692967|NCT01422213|Secondary|Proportion of Responders at Week 8 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline||Baseline and Week 8|FAS, last observation carried forward (LOCF)||percentage of participants|||Number
692968|NCT01422213|Secondary|Clinical Status Using CGI-I Score at Week 8|The Clinical Global Impression - Global Improvement (CGI-I) is a 7-point scale rated from 1 (very much improved) to 7 (very much worse). The investigator rated the patient's overall improvement relative to baseline, whether or not, in the opinion of the investigator, this was entirely due to the drug treatment.|Week 8|FAS||units on a scale||Standard Error|Mean
692969|NCT01422213|Secondary|Change From Baseline to Week 8 in CGI-S Score|The Clinical Global Impression - Severity of Illness (CGI-S) is a 7-point scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The investigator should use his/her total clinical experience with this patient population to judge how mentally ill the patient is at the time of rating.|Baseline and Week 8|FAS||units on a scale||Standard Error|Mean
692970|NCT01422213|Secondary|Change From Baseline to Week 8 in MADRS Total Score|The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe.|Baseline and Week 8|FAS||units on a scale||Standard Error|Mean
692971|NCT01422213|Secondary|Change From Baseline to Week 8 in the CRT (Attention)||Baseline and Week 8|FAS||log10 (ms)||Standard Error|Mean
692972|NCT01422213|Secondary|Change From Baseline to Week 8 in the SRT (Speed of Processing)|"Simple Reaction Time (SRT) is designed to assess psychomotor speed, and Choice Reaction Time (CRT) is designed to assess visual attention. Two computerised tests, part of the CogState battery were used to measure SRT and CRT in milliseconds:
The detection task measures SRT: the patient presses a yes button, whenever an onscreen playing card is turned over.
The identification task measures CRT: the patient presses a yes button whenever an onscreen playing card is turned over and is red, or a no button if the card is not red."|Baseline and Week 8|FAS||log10 (ms)||Standard Error|Mean
692973|NCT01422213|Secondary|Change From Baseline to Week 8 in Incongruent STROOP Time to Complete (Executive Function)||Baseline and Week 8|FAS||seconds||Standard Error|Mean
692974|NCT01422213|Secondary|Change From Baseline to Week 8 in Congruent STROOP Time to Complete (Executive Function)|Stroop Colour Naming Test (STROOP) is a cognitive test designed to assess the ability to inhibit a prepotent response to reading words while performing a task that requires attention control. It comprises two sheets with 50 words on each, and each word is the name of a colour. On the first sheet, the Congruent STROOP Sheet, the word and ink colour match; on the Incongruent STROOP Sheet, the word and ink colour do not match. For each sheet, the patient has 4 minutes to name the ink colour of each word. When the patient finishes the sheet, or once 4 minutes is up, the clinician notes the time taken and counts the number of correct and incorrect responses. The scale ranges from 0-100, the higher score the greater the cognitive flexibility.|Baseline and Week 8|FAS||seconds||Standard Error|Mean
692975|NCT01422213|Secondary|Change From Baseline to Week 8 in the TMT B (Executive Function)|TMT is a cognitive test designed to assess scanning, visuomotor tracking, executive function, and cognitive flexibility. It consists of two parts, A and B: the patient must draw lines to connect consecutively numbered circles (part A) and then connect consecutively numbered and lettered circles alternating between the two sequences (part B). The time taken to complete the two parts is recorded. Part B examines executive functioning and ability to shift cognitive set. The lower the score the faster the ability to shift cognitive set.|Baseline and Week 8|FAS||seconds||Standard Error|Mean
692976|NCT01422213|Secondary|Change From Baseline to Week 8 in the TMT A (Speed of Processing)|Trail Making Test (TMT) is a cognitive test designed to assess scanning, visuomotor tracking, executive function, and cognitive flexibility. It consists of two parts, A and B: the patient must draw lines to connect consecutively numbered circles (part A) and then connect consecutively numbered and lettered circles alternating between the two sequences (part B). The time taken to complete the two parts is recorded. Part A assesses cognitive processing speed. The lower the score the faster the processing speed.|Baseline and Week 8|FAS||seconds||Standard Error|Mean
692977|NCT01422213|Secondary|Change From Baseline to Week 8 in RAVLT (Delayed Recall)|Rey Auditory Verbal Learning Task (RAVLT) is a cognitive test designed to assess verbal learning and memory, including immediate memory, efficiency of learning, retroactive and proactive interference effects, and encoding versus retrieval. It consists of a number of tasks, including immediate recall and delayed recall. The number of words correctly recalled on each task is recorded.|Baseline and Week 8|FAS||number of words correctly recalled||Standard Error|Mean
694661|NCT01398982|Secondary|Daily Pain Intensity Scores at Rest and With Movement|Daily pain intensity scores at rest and with movement using a visual pain analogue scale (0-10)|In Hospital postoperative measures, average 4-5 days||||||
692979|NCT01422213|Secondary|Change From Baseline to Week 8 in DSST (Number of Correct Symbols)|"Digit Symbol Substitution Test (DSST) is a cognitive test designed to assess psychomotor speed of performance requiring visual perception, spatial decision-making, and motor skills. It consists of 133 digits and requires the patient to substitute each digit with a simple symbol in a 90-second period. Each correct symbol is counted, and the total score ranges from 0 (less than normal functioning) to 133 (greater than normal functioning). as a description of DSST."|Baseline and Week 8|FAS||number of correct symbols||Standard Error|Mean
692980|NCT01422213|Primary|Change From Baseline to Week 8 in DSST (Number of Correct Symbols) and RAVLT (Acquisition and Delayed Recall) Using the Composite Z-score Defined as the Weighted Sum of the Individual Patient Z-scores|"DSST assesses psychomotor speed of performance requiring visual perception, spatial decision-making, and motor skills. It consists of 133 digits and requires the patient to substitute each digit with a simple symbol in a 90-s period. Each correct symbol is counted, and the total score ranges from 0 (< normal functioning) to 133 (> normal functioning).
RAVLT assesses verbal learning and memory, including immediate memory, efficiency of learning, retroactive and proactive interference effects, and encoding versus retrieval. It consists of a number of tasks, including immediate recall and delayed recall. The number of words correctly recalled on each task is recorded.
The scores are standardized by subtracting the overall mean change from baseline from the individual change from baseline and dividing by the standard deviation estimate of the change from baseline. The 2 tests, DSST and RAVLT are each assigned a weight of 0.5, the 2 subtests of RAVLT are each assigned a weight of 0.25."|Baseline and Week 8|FAS||z score||Standard Error|Mean
692981|NCT01422187|Secondary|Hemoglobin|Hemoglobin measure yearly|60 months|||mg/dL||Standard Error|Mean
692982|NCT01422187|Secondary|Platelet Count|Platelet count measure annually|60 months|||platelets/mm^3||Standard Error|Mean
692983|NCT01422187|Secondary|Liver Volume|Liver volume by MRI|60 months|||Milliliters||Standard Error|Mean
692984|NCT01422187|Primary|Spleen Volume|Spleen volume measured by MRI|60 months|||Milliliters||Standard Error|Mean
692985|NCT01422070|Secondary|Number of ICU Readmissions|Number of readmissions to intensive care unit during the same hospital course|Max 90 days after admission to the Study Unit|||readmissions|||Number
692986|NCT01422070|Secondary|Length of Hospital Stay|Number of days (calendar days -1) from admission to the Study Unit to discharge from the hospital|Max 90 days after admission to the Study Unit|||days||Inter-Quartile Range|Median
692987|NCT01422070|Secondary|Length of ICU Stay|Number of days (calendar days -1) from admission to and discharge from the Study Unit|Max 90 days after admission to intensive care unit|||days||Inter-Quartile Range|Median
692988|NCT01422070|Primary|Vital Status at Hospital Discharge|Hospital mortality of the patients admitted to intensive care units with or without intermediate care unit in the hospital|Max 90 days after admission to the Study Unit|||participants|||Number
692989|NCT01421719|Primary|Number of Patients Requiring Catheterization for Urinary Retention Secondary to Treatment.|Requirement for catheter because of urinary retention.|zero to six months|||participants|||Number
692990|NCT01421719|Secondary|Number of Incontinence Episodes Per Day|Urinary incontinence 6 months after treatment (n=16). Data are included for participants who completed all diary entries and attended the Month 6 visit|6 months|Per protocol. Quantified from 3-day voiding diary at baseline and each clinical evaluation to 6 months. Mean change in daily incontinence made up analysis.||leaks/day||Standard Deviation|Mean
692991|NCT01421667|Secondary|Baseline Soluble CD30 Expression|Serum concentration of soluble CD30 before first dose of brentuximab vedotin|Baseline|All patients who were treated with brentuximab vedotin monotherapy and had baseline sCD30 expression results.||ng/mL||Full Range|Median
692992|NCT01421667|Secondary|Time to Maximum Concentration (Tmax) of Brentuximab Vedotin Monomethyl Auristatin E (MMAE)|Time of maximum serum concentration of MMAE from 0 to 21 days following the first dose of brentuximab vedotin|3 weeks|All patients who were treated with brentuximab vedotin monotherapy and had Tmax of MMAE results.||days||Full Range|Median
692993|NCT01421667|Secondary|Maximum Concentration (Cmax) of Brentuximab Vedotin Monomethyl Auristatin E (MMAE) (Cycle 1)|Maximum serum concentration of MMAE from 0 to 21 days following the first dose of brentuximab vedotin|3 weeks|All patients who were treated with brentuximab vedotin monotherapy and had Cmax of MMAE results.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
692994|NCT01421667|Secondary|Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Trough Concentration (Ctrough) (Cycle 1)|Trough concentration of ADC from 0 to 21 days following the first dose of brentuximab vedotin|3 weeks|All patients who were treated with brentuximab vedotin monotherapy and had Ctrough of ADC results.||ug/mL||Geometric Coefficient of Variation|Geometric Mean
692995|NCT01421667|Secondary|Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Concentration at End of Infusion (Ceoi) (Cycle 1)|End of infusion concentration of ADC following the first dose of brentuximab vedotin|1 day|All patients who were treated with brentuximab vedotin monotherapy and had Ceoi of ADC results.||ug/mL||Geometric Coefficient of Variation|Geometric Mean
692996|NCT01421667|Secondary|Adverse Events by Severity, Seriousness, and Relationship to Treatment With Brentuximab Vedotin Monotherapy|Counts of participants who had treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose on Study SGN35-012). Serious adverse events are reported from the time of informed consent. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.03) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life-threatening/disabling, 5=fatal). Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an adverse event within a category are counted once within the category.|Up to 3 years|All participants who received treatment with brentuximab vedotin monotherapy.||participants|||Number
692997|NCT01421667|Secondary|Correlation Between Antitumor Activity of Brentuximab Vedotin Monotherapy and CD30 Expression|Percentage of participants treated with brentuximab vedotin monotherapy who achieved a best response of complete remission (CR, disappearance of all evidence of disease), partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites), or stable disease (SD, no new sites and no change in size of previous lesions) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma. Patients are grouped by CD30-positivity or CD30u (undetectable CD30).|Up to 3 years|All participants who received treatment with brentuximab vedotin monotherapy and had both a baseline and at least one post-baseline disease assessment.||percentage of participants||95% Confidence Interval|Number
692999|NCT01421667|Secondary|Duration of Complete Remission With Brentuximab Vedotin Monotherapy by Kaplan-Meier Analysis|Duration of complete remission (CR), defined as time of initial response until disease progression or death. Response criteria per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.|Up to approximately 3 years|All participants who received treatment with brentuximab vedotin monotherapy and achieved CR||months||Full Range|Median
693000|NCT01421667|Secondary|Duration of Objective Response With Brentuximab Vedotin Monotherapy by Kaplan-Meier Analysis|Duration of complete remission (CR) or partial remission (PR), defined as time of initial response until disease progression or death. Response criteria per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.|Up to approximately 3 years|All participants who received treatment with brentuximab vedotin monotherapy and achieved a CR or PR.||months||Full Range|Median
693001|NCT01421667|Secondary|Complete Remission (CR) Rate by Investigator|Percentage of participants treated with brentuximab vedotin monotherapy or brentuximab vedotin plus rituximab who achieved a best response of complete remission (CR, disappearance of all evidence of disease) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.|Up to approximately 3 years|All participants who received brentuximab vedotin monotherapy or brentuximab vedotin plus rituximab and had both a baseline and at least one post-baseline disease assessment.||percentage of participants||95% Confidence Interval|Number
693002|NCT01421667|Secondary|Objective Response Rate (ORR) by Investigator With Brentuximab Vedotin Plus Rituximab|Percentage of participants treated with brentuximab vedotin plus rituximab who achieved a best response of complete remission (CR, disappearance of all evidence of disease) or partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.|Up to approximately 3 years|All participants who received treatment with brentuximab vedotin plus rituximab and had both a baseline and at least one post-baseline disease assessment.||percentage of participants||95% Confidence Interval|Number
693003|NCT01421667|Primary|Adverse Events by Severity, Seriousness, and Relationship to Treatment With Brentuximab Vedotin Plus Rituximab|Counts of participants who had treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose on Study SGN35-012). Serious adverse events are reported from the time of informed consent. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.03) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life-threatening/disabling, 5=fatal). Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an adverse event within a category are counted once within the category.|Up to 3 years|All participants who received treatment with brentuximab vedotin plus rituximab.||participants|||Number
693004|NCT01421667|Primary|Objective Response Rate (ORR) by Investigator With Brentuximab Vedotin Monotherapy|Percentage of participants treated with brentuximab vedotin monotherapy who achieved a best response of complete remission (CR, disappearance of all evidence of disease) or partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.|Up to approximately 3 years|All participants who received treatment with brentuximab vedotin monotherapy and had both a baseline and at least one post-baseline disease assessment.||percentage of participants||95% Confidence Interval|Number
693005|NCT01421654|Primary|Hours Used|The number of hours that each group used the device will be compared between subjects using fixed pressure with the Acclimate mode and subjects using fixed pressure without the Acclimate mode.|30 days|||Total Hours Used||Standard Deviation|Mean
693006|NCT01421641|Secondary|Tenaculum Placement Satisfaction|Satisfaction with overall tenaculum placement procedure. Subjects asked to answer their overall satisfaction with the pain control. Subjects asked to complete 100mm Visual Analog Scale (0mm=not at all satisfied to 100mm=very satisfied)|After placement of the tenaculum|||mm||Standard Deviation|Mean
693007|NCT01421641|Secondary|Intervention Pain|Pain with the intervention (injection or gel application). Subjects are asked to complete pain scale using a 100mm Visual Analog Scale (0mm=no pain and 100mm=worst pain of my life)|after application of randomized intervention|||mm||Standard Deviation|Mean
693008|NCT01421641|Primary|Tenaculum Pain|The primary outcome was pain at the time of tenaculum placement. Patient asked to pain scale using 100mm Visual Analog Scale (0mm=no pain, 100mm=worst pain of my life) during after tenaculum placement.|After tenaculum placement|4 subjects were excluded due to protocol violations||mm||Standard Deviation|Mean
693009|NCT01421589|Secondary|Change in Phosphocreatine Recovery|Change in phosphocreatine recovery, represented by ViPCr, from Baseline to 12-weeks is reported.|Baseline and 12-weeks|Obese men with reduced GH secretion were treated with rhGH for 12 weeks. All 15 subjects underwent 31P-MRS, however, two scans were not evaluable due to technical difficulties.||mM/min||Standard Error|Mean
693010|NCT01421589|Secondary|Change in Insulin Sensitivity|Change in fasting glucose from Baseline to 12-weeks is reported.|Baseline and 12-weeks|||mg/dl||Standard Error|Mean
693011|NCT01421589|Secondary|Change in Inflammatory Marker|Change in high sensitivity C-reactive protein (hsCRP) from Baseline to 12-weeks is reported.|Baseline and 12-weeks|||mg/l||Standard Error|Mean
693012|NCT01421589|Secondary|Change in Body Composition|Change in waist circumference from Baseline to 12-weeks is reported.|Baseline and 12-weeks|||cm||Standard Error|Mean
693013|NCT01421589|Secondary|Change in Skeletal Muscle IGF-1 Gene Expression|Change in skeletal muscle IGF-1 gene mRNA expression from Baseline to 12-weeks is reported.|Baseline and 12-weeks|Paired analyses (both Baseline and 12-weeks) from only 10 subjects are available for gene expression||fold change||Standard Error|Mean
693014|NCT01421589|Secondary|Change in Circulating IGF-1 Concentration|Change in circulating IGF-1 from Baseline to 12-weeks is reported.|Baseline and 12-weeks|||ug/l||Standard Error|Mean
693015|NCT01421589|Primary|Phosphocreatine Recovery|The primary objective of this study is to determine the effects of growth hormone on mitochondrial function as assessed by 31P-MRS in obese subjects with reduced GH secretion. Mitochondrial function was represented by ViPCr, a measure of phosphocreatine recovery after sub-maximal exercise. Univariate regression analyses was performed to assess the relationship between the change in skeletal muscle IGF-1 mRNA after 12 weeks treatment with rhGH to change in ViPCr.|12-weeks|All 15 subjects underwent 31P-MRS, however, two scans were not evaluable due to technical difficulties. In addition, paired analyses (both Baseline and 12-weeks) from only 10 subjects were available for gene expression analyses. Therefore univariate regression analyses between IGF-1 mRNA and PCr recovery could only be performed in 10 subjects.||correlation coefficient|||Number
693019|NCT01421511|Secondary|Investigator's Assessment of Clinical Success of the Post Therapy Evaluation Visit in Clinically Evaluable-Post Treatment Evaluation Analysis Set.|Clinical success defined as resolution/near resolution of disease specific signs and symptoms, absence/near resolution of baseline systemic signs of infection, no new signs, symptoms or complications attributable to the ABSSSI and no further antibiotic therapy required for treatment of primary ABSSSI lesion.|Post-Treatment Evaluation (7-14 days after the End of Therapy)|All randomized participants receiving minimal study therapy, completed EOT and PTE Investigator's assessments, no concomitant systemic antibiotic therapy through PTE, and no confounding events or factors.||participants|||Number
693020|NCT01421511|Secondary|Investigator’s Assessment of Clinical Success at the Post Treatment Evaluation Visit|Clinical success defined as resolution/near resolution of disease specific signs and symptoms, absence/near resolution of baseline systemic signs of infection, and no further antibiotic therapy required for treatment of primary ABSSSI lesion.|Post-Treatment Evaluation (7-14 days after the End of Therapy)|The Intent to Treat analysis set includes data from all randomized participants.||participants|||Number
693021|NCT01421511|Secondary|Clinical Response at the End of Therapy Visit in the Clinically Evaluable at End of Therapy Analysis Set|Responder: No increase in lesion surface area from baseline.|End of Therapy Day 11|All randomized participants receiving minimal study therapy, completed EOT assessment, no concomitant systemic antibiotic therapy and no confounding events or factors.||participants|||Number
693022|NCT01421511|Secondary|Clinical Response at the End of Therapy Visit|Responder: No increase in lesion surface area from baseline.|Day 11|The Intent to Treat analysis set includes data from all randomized participants.||participants|||Number
693023|NCT01421511|Primary|The Early Clinical Response Rate|Responder: No increase in lesion surface area from baseline.|48-72 hours|The Intent to Treat analysis set includes data from all randomized participants.||participants|||Number
693024|NCT01421498|Primary|Ocular Symptom: Change From Baseline in Visual-Related Subscale of the Symptom Functional Scale Score to Day 84|The symptom functional scale is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers. The 12 items of the symptom functional scale questionnaire were graded on a scale of 0 (none of the time) to 4 (all of the time). The index consisted of 3 sub scales: symptoms (sensitivity to light, gritty sensation, pain, blurred vision, and poor vision [Items 1-5]), visual-related sub scale of the symptom functional scale (ability to read, drive at night, use a computer, watch television [Items 6–9]), and environmental triggers (windy conditions, low humidity, air conditioning [Items 10–12]). The symptom functional scale was scored on a scale of 0 to 100, with higher scores representing greater disability. Negative change from baseline indicates improvement.|Baseline (Day 0) to Day 84|ITT population with LOCF.||units on a scale||Standard Deviation|Mean
693025|NCT01421498|Primary|Ocular Sign: Change From Baseline in Inferior Corneal Fluorescein Staining to Day 84|Corneal staining was performed to grade the degree of corneal epithelial cell injury as measured by fluorescence using slit-lamp examination. The staining was graded with the Ophthalmic Research Associates, Inc. (ORA) scale. The corneal surface is divided into three regions: superior, central and inferior. The scores for each of these 3 regions ranged from 0 to 4 (0=no staining/none; 1=occasional/trace; 2=countable/mild; 3=uncountable, but not confluent/moderate; 4=confluent/severe) with 0.5 point increments, and lower score indicates a better outcome. Inferior corneal fluorescein staining scores from the study eye only were reported. Study eye is the ‘worse eye’, defined as the eye with worse (higher) score at baseline.|Baseline (Day 0) to Day 84|Intent-to-Treat (ITT) population with Last Observation Carried Forward (LOCF) included all randomized participants who received at least 1 dose of investigational product.||units on a scale||Standard Deviation|Mean
693026|NCT01421472|Primary|Number of Participants With Pathologic Complete Response (pCR) (Rate of pCR)|Pathologic Complete Response was defined as the absence of invasive cancer in the breast and lymph nodes following completion of neoadjuvant systemic therapy and reported according to the current AJCC staging system for neoadjuvant clinical studies. The endpoint was to determine the pathologic Complete Response (pCR) rates associated with weekly treatment of MM-121 plus paclitaxel followed by the combination treatment of doxorubicin plus cyclophosphamide compared with weekly paclitaxel alone followed by the combination treatment of doxorubicin plus cyclophosphamide in patients with human epidermal growth factor receptor 2 (HER2)-negative primary breast cancer.|At time of surgery, an expected average of 24-26 weeks|Subjects with evaluable resection.||participants|||Number
693027|NCT01421459|Other Pre-specified|Percentage of Participants With Treatment Emergent Antibody Response (TEAR)|TEAR is defined as an absolute increase of at least 1% in insulin antibody levels (measured in % binding) and at least 30% relative increase from Baseline for participants who are insulin antibody-positive at Baseline, or turning from insulin antibody-negative status at Baseline to antibody-positive during the course of the study following treatment with study drug.|4 weeks and 12 weeks and 24 weeks and Endpoint (up to 24 weeks) and Baseline to 24 weeks (Overall)|All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline analysis to detect insulin antibodies; last observation carried forward (LOCF).||percentage of participants|||Number
693028|NCT01421459|Other Pre-specified|Percentage of Participants With Detectable Insulin Antibody Levels||Baseline and 4 weeks and 12 weeks and 24 weeks and Endpoint (up to 24 weeks) and Baseline to 24 weeks (Overall)|All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline analysis to detect insulin antibodies; last observation carried forward (LOCF).||percentage of participants|||Number
693029|NCT01421459|Secondary|Rate Per 30 Days of Hypoglycemic Events|The rate of hypoglycemic events per 30 days between two visits is defined as the total number of events between the visits divided by the actual number of days between the visits, and then multiplied by 30 days. A hypoglycemic event is defined as any time a participant has a blood glucose (BG) level of ≤70 milligrams per deciliter (mg/dL) even if the event was not associated with signs, symptoms, or treatment consistent with current guidelines (American Diabetes Association 2005). Nocturnal hypoglycemia is defined as any hypoglycemic event that occurs between bedtime and waking. Severe hypoglycemia is defined as a hypoglycemic event requiring assistance of another person to actively administer carbohydrates, glucagons, or other resuscitative actions. Severe Hypoglycemic events may or may not have a reported BG ≤70 mg/dL. These events may be associated with sufficient neuroglycopenia to induce seizure or coma.|Baseline, Endpoint (up to 24 weeks)|All randomized participants who received at 1 dose of study drug with Baseline at least 1 post-Baseline hypoglycemic event.||hypoglycemic events per 30 days||Standard Deviation|Mean
693030|NCT01421459|Secondary|Incidence of Hypoglycemic Events|A hypoglycemic event is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia, or has blood glucose (BG) concentration of ≤70 milligrams/deciliter (mg/dL) even if it was not associated with signs, symptoms, or treatment consistent with current American Diabetes Association (ADA: 2005) guidelines. Severe hypoglycemia is defined as a hypoglycemic event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions (these episodes may be associated with sufficient neuroglycopenia to induce seizure or coma; also, BG measurements may not be available during such an event). Nocturnal hypoglycemia is defined as any hypoglycemic event that occurs between bedtime and waking.|Baseline and Endpoint (up to 24 weeks)|All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline hypoglycemic event measure.||hypoglycemic events in 24 weeks|||Number
693031|NCT01421459|Secondary|Percentage of Participants With HbA1c <7 % and HbA1c ≤6.5%|Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time.|Baseline and 4 weeks and 8 weeks and 12 weeks and 16 weeks and 20 weeks and 24 weeks and Endpoint (up to 24 weeks)|All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline HbA1c measure; last observation carried forward (LOCF).||percentage of participants|||Number
693032|NCT01421459|Secondary|Insulin Dose (Units)|Units of insulin taken daily. Least Square (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1C, country, sulfonylurea use, time of basal insulin injection and treatment.|Endpoint (up to 24 weeks)|All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline insulin dose measure; last observation carried forward (LOCF).||units per day (U/day)||Standard Error|Least Squares Mean
693033|NCT01421459|Secondary|Insulin Dose Per Body Weight (U/kg) Per Day|Insulin dose in units (U) per body weight in kilograms (kg) per day. Least Squares (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1c, country, sulfonylurea use, time of basal insulin injection, and treatment.|Endpoint (up to 24 weeks)|All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline Insulin Dose per Body Weight measure; last observation carried forward (LOCF).||units per kilogram per day (U/kg/day)||Standard Error|Least Squares Mean
693034|NCT01421459|Secondary|Insulin Treatment Satisfaction Questionnaire (ITSQ)|ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. Items divided into 5 domains of satisfaction: Inconvenience of Regimen [(IR) 5 items: domain scores range (DSR) 5-35], Lifestyle Flexibility [(LF) 3 items: DSR 3-21], Glycemic Control [(GC) 3 items: DSR 3-21], Hypoglycemic Control [(HC) 5 items: DSR 5-35], Insulin Delivery Device [(IDD) 6 items: DSR 6-42]. All items measured on a 7-point scale: 1 (no bother at all) to 7 (a tremendous bother), with lower scores reflecting better outcomes. ITSQ Total Overall Raw Scores range from 22-154. Both raw domain and overall scores are transformed on a scale of 0-100, where transformed score=100*[(7-mean raw score)/6]. Higher scores indicate better treatment satisfaction. Least Squares (LS) mean are determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1c, country, sulfonylurea use, time of basal insulin injection, and treatment.|4 weeks (wk) and 12 wk and Endpoint (EP) (up to 24 wk)|All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline ITSQ measure; last observation carried forward (LOCF).||units on a scale||Standard Error|Least Squares Mean
693035|NCT01421459|Secondary|Adult Low Blood Sugar Survey (ALBSS)|"ALBSS contains 33 items, with each item scored on a 5-point response scale: 0 (never) to 4 (almost always). Items are categorized in 2 domains: Behavior (or avoidance) Items 1 to 15 and Worry (or affect) Items 16 to 33. Behavior Total Score range is 0 to 60 and Worry Total Score range is 0 to 72. Higher scores on “Behavior” items (related to avoidance of hypoglycemia) reflect greater awareness and/or effort of the participant to prevent low blood sugar. Higher scores on Worry items (related to worries about low blood sugar and its consequences) reflect greater participant concern about having low blood sugar. The ALBSS Total Scores (Worry and Behavior item scores combined) range is 0 to 132. Least Squares (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1c, country, sulfonylurea use, time of basal insulin injection, and treatment."|4 weeks (wk) and 12 wk and Endpoint (up to 24 wk)|All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline ALBSS measure; last observation carried forward (LOCF).||units on a scale||Standard Error|Least Squares Mean
693036|NCT01421459|Secondary|Change From Baseline in Body Weight|Change from baseline in body weight. Least Squares (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1c, country, sulfonylurea use, time of basal insulin injection, and treatment.|Baseline and 4 weeks (wk) and 8 wk and 12 wk and 16 wk and 20 wk and 24 wk and Endpoint (up to 24 wk)|All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline body weight measure; last observation carried forward (LOCF).||kilogram (kg)||Standard Error|Least Squares Mean
693037|NCT01421459|Secondary|Glycemic Variability of Fasting Blood Glucose|Glycemic variability is measured by the intra-participant standard deviation (SD) value of fasting blood glucose as measured by the actual morning pre-meal blood glucose value from the 7-point self-monitoring blood glucose [SMBG] profiles. Least Squares (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for baseline HbA1c, country, sulfonylurea use, time of basal insulin injection, and treatment.|Baseline and Endpoint (up to 24 weeks)|All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline fasting blood glucose measure; last observation carried forward (LOCF).||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
693038|NCT01421459|Secondary|7-Point Self-Monitored Blood Glucose (SMBG) Profiles|Seven-point SMBG are completed at the following timepoints: Morning (AM) Pre-Meal, Morning (AM) Post-Prandial (PP), Midday (MD) Pre-Meal, Midday PP, Evening (EV) Pre-Meal, Bed Time and 0300 hours. PP glucose is measured 2 hours (hrs) after the start of the meal. Least Squares (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1c, country, sulfonylurea use, time of basal insulin injection, and treatment.|Baseline and Endpoint [up to 24 weeks (wk)]|All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline SMBG measure; last observation carried forward (LOCF).||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
694662|NCT01398982|Secondary|Total In-hospital Cumulative Opioid Consumption|Total in-hospital cumulative opioid consumption levels|In-patient hospital stay average of 4 - 5 days||||||
693039|NCT01421459|Secondary|Change From Baseline in Hemoglobin A1c (HbA1c)|HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1c, country, sulfonylurea use, time of basal insulin injection and treatment.|Baseline and 4 weeks and 8 weeks and 12 weeks and 16 weeks and 20 weeks and 24 weeks|All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline HbA1c measure.||percentage of HbA1c||Standard Error|Least Squares Mean
693040|NCT01421459|Secondary|Change From Baseline in Insulin Antibody Levels|Blood samples are collected from participants and percentage of insulin antibody binding measured. Least Squares (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for Baseline of response and treatment.|Baseline and 4 weeks and 12 weeks and Endpoint (24 weeks and up to 24 weeks)|All randomized participants who received at least 1 dose of study drug and with a Baseline and at least 1 post-Baseline insulin antibody measure; last observation carried forward (LOCF).||percentage of insulin antibody binding||Standard Error|Least Squares Mean
693041|NCT01421459|Primary|Change From Baseline up to 24 Weeks in Hemoglobin A1c (HbA1c)|HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1c, country, sulfonylurea use, time of basal insulin injection and treatment.|Baseline, Endpoint (up to 24 weeks)|All randomized participants who received at least 1 dose of study drug and with a Baseline and at least 1 post-Baseline HbA1c measure; last observation carried forward (LOCF).||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
693042|NCT01421355|Primary|Change in Brachial Artery Diameter|The primary endpoint is the difference in the change in brachial artery diameter in response to a flow stimulus at visit 2 and 3. It is anticipated that a response will occur following atazanavir therapy compared with baseline. The principal secondary endpoints are the serum measures of oxidant stress and antioxidant capacity.|Day 0 and Day 4|||percentage of dilation||Standard Deviation|Mean
693043|NCT01421303|Secondary|Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and Euro Quality of Life (EQ-5D) Visual Analog Scale (VAS) Score at Month 6 and 24|WPAI-AS:6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment due to AS for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed(absenteeism), impairment while working(presenteeism), overall work impairment(work productivity), activity impairment(daily activity impairment). These sub-scores are transformed to impairment percentages(range 0 to 100), with higher numbers indicating greater impairment, less productivity. EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. Correlation coefficient between change from baseline in WPAI-AS and EQ-5D VAS score at Month 6, 24 was reported.|Month 6, Month 24|FAS consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable at the specified time points for the given sub-scale items.||Correlation coefficient|||Number
693044|NCT01421303|Secondary|Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and Euro Quality of Life (EQ-5D) Visual Analog Scale (VAS) Score at Baseline|WPAI-AS:6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment due to AS for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed(absenteeism), impairment while working(presenteeism), overall work impairment(work productivity), activity impairment(daily activity impairment). These sub-scores are transformed to impairment percentages(range 0 to 100), with higher numbers indicating greater impairment, less productivity. EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. Correlation coefficient between WPAI-AS and EQ-5D VAS score at baseline was reported.|Baseline|BAS consisted of all participants enrolled in the study, who were seen at baseline and started the treatment with etanercept (Enbrel). Here 'n' signifies those participants who were evaluable for the given scale item at baseline.||Correlation coefficient|||Number
693045|NCT01421303|Secondary|Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and Euro Quality of Life-5 Dimensions (EQ-5D) Total Score at Month 6 and 24|WPAI-AS:6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment due to AS during 7 days prior to each visit. It yields 4 sub-scores: work time missed(absenteeism), impairment while working(presenteeism), overall work impairment(work productivity), activity impairment(daily activity impairment). These sub-scores are transformed to impairment percentages(range 0 to 100), with higher numbers=greater impairment, less productivity. EQ-5D:participant rated questionnaire to assess health-related quality of life in terms of single utility score. Health state profile component assesses level of current health for 5 domains: mobility,self-care,usual activities,pain/discomfort and anxiety/depression; Scale range 1 to 3 (1=better health state [no problems], 3=worst health state [confined to bed]). Correlation coefficient between change from baseline in WPAI-AS and EQ-5D total score at Month 6, 24 was reported.|Month 6, Month 24|FAS consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable at the specified time points for the given sub-scale items.||Correlation coefficient|||Number
693046|NCT01421303|Secondary|Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and Euro Quality of Life-5 Dimensions (EQ-5D) Total Score at Baseline|WPAI-AS:6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment due to AS during 7 days prior to each visit. It yields 4 sub-scores: work time missed(absenteeism), impairment while working(presenteeism), overall work impairment(work productivity), activity impairment(daily activity impairment). These sub-scores are transformed to impairment percentages(range 0 to 100), with higher numbers=greater impairment, less productivity. EQ-5D:participant rated questionnaire to assess health-related quality of life in terms of single utility score. Health state profile component assesses level of current health for 5 domains: mobility,self-care,usual activities,pain/discomfort and anxiety/depression; Scale range 1 to 3 (1=better health state [no problems], 3=worst health state [confined to bed]). Correlation coefficient between WPAI-AS and EQ-5D total score at baseline was reported.|Baseline|BAS consisted of all participants enrolled in the study, who were seen at baseline and started the treatment with etanercept (Enbrel). Here 'n' signifies those participants who were evaluable for the given scale item at baseline.||Correlation coefficient|||Number
693047|NCT01421303|Secondary|Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and 36-Item Short-Form Health Survey (SF-36) Mental Component Summary Score (MCS) at Month 6 and 24|WPAI-AS:6-item questionnaire to determine amount of absenteeism,presenteeism,work productivity loss,daily activity impairment attributable to AS during 7 days prior to each visit.It yields 4 sub-scores:work time missed(absenteeism),impairment while working(presenteeism),overall work impairment(work productivity), activity impairment(daily activity impairment).Sub-scores transformed to impairment percentages(range 0 to 100), higher numbers=greater impairment,less productivity.SF-36:standardized survey evaluating 8 aspects of functional health,well being(physical,social functioning; physical,emotional role limitations; bodily pain; general health; vitality; mental health).8 aspects summarized as PCS and MCS. Scores normalized to United States population to have mean=50,standard deviation=10(norm based scoring with <50=lower level of functioning and >50=higher level of functioning). Correlation coefficient between change from baseline in WPAI-AS and MCS score at Month 6, 24 was reported.|Month 6, Month 24|FAS consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable at the specified time points for the given sub-scale items.||Correlation coefficient|||Number
693048|NCT01421303|Secondary|Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and 36-Item Short-Form Health Survey (SF-36) Mental Component Summary Score (MCS) at Baseline|WPAI-AS: 6-item questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment attributable to AS during 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism), overall work impairment (work productivity), activity impairment (daily activity impairment). Sub-scores transformed to impairment percentages (range 0 to 100), higher numbers=greater impairment,less productivity. SF-36:standardized survey evaluating 8 aspects of functional health, well being (physical, social functioning; physical, emotional role limitations; bodily pain; general health; vitality; mental health). 8 aspects summarized as PCS and MCS. Scores normalized to United States population to have mean=50, standard deviation=10 (norm based scoring with <50=lower level of functioning and >50=higher level of functioning). Correlation coefficient between WPAI-AS and MCS score at baseline was reported.|Baseline|BAS consisted of all participants enrolled in the study, who were seen at baseline and started the treatment with etanercept (Enbrel). Here 'n' signifies those participants who were evaluable for the given scale item at baseline.||Correlation coefficient|||Number
693049|NCT01421303|Secondary|Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and 36-Item Short-Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Month 6 and 24|WPAI-AS:6-item questionnaire to determine amount of absenteeism,presenteeism,work productivity loss,daily activity impairment attributable to AS during 7 days prior to each visit.It yields 4 sub-scores:work time missed(absenteeism),impairment while working(presenteeism),overall work impairment(work productivity),activity impairment(daily activity impairment).Sub-scores transformed to impairment percentages(range 0 to 100),higher numbers=greater impairment,less productivity.SF-36:standardized survey evaluating 8 aspects of functional health,well being(physical,social functioning; physical,emotional role limitations; bodily pain; general health; vitality; mental health).8 aspects summarized as PCS and MCS. Scores normalized to United States population to have mean=50,standard deviation=10 (norm based scoring with <50=lower level of functioning and >50=higher level of functioning). Correlation coefficient between change from baseline in WPAI-AS and PCS score at Month 6, 24 was reported.|Month 6, Month 24|FAS consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable at the specified time points for the given sub-scale items.||Correlation coefficient|||Number
693050|NCT01421303|Secondary|Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and 36-Item Short-Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Baseline|WPAI-AS:6-item questionnaire to determine amount of absenteeism,presenteeism,work productivity loss,daily activity impairment attributable to AS during 7 days prior to each visit.It yields 4 sub-scores:work time missed(absenteeism),impairment while working(presenteeism),overall work impairment(work productivity), activity impairment(daily activity impairment).Sub-scores transformed to impairment percentages(range 0 to 100), higher numbers=greater impairment,less productivity.SF-36:standardized survey evaluating 8 aspects of functional health,well being(physical,social functioning; physical,emotional role limitations; bodily pain; general health; vitality; mental health).8 aspects summarized as PCS and mental component summary (MCS).Scores normalized to United States population to have mean=50,standard deviation=10 (norm based scoring with <50=lower level of functioning and >50=higher level of functioning). Correlation coefficient between WPAI-AS and PCS score at baseline was reported.|Baseline|BAS consisted of all participants enrolled in the study, who were seen at baseline and started the treatment with etanercept (Enbrel). Here 'n' signifies those participants who were evaluable for the given scale item at baseline.||Correlation coefficient|||Number
699288|NCT00002540|Secondary|T1 PSA Screening Results|Prostate-Specific Antigen (PSA) result.|T1 (one year after entry)|All males in the Prostate Screening arm who had a PSA screen at T1 were analyzed.||Participants|||Number
693051|NCT01421303|Secondary|Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Global Score (BAS-G) at Month 6 and 24|WPAI-AS:6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment due to AS for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed(absenteeism), impairment while working(presenteeism), overall work impairment(work productivity), activity impairment(daily activity impairment). These sub-scores are transformed to impairment percentages(range 0 to 100), with higher numbers indicating greater impairment, less productivity. BAS-G is used to indicate the effect of disease on participant's well-being. This scale is composed of 2 items ranging from 0 = very good to 10 =very bad. Total score ranges from 0 to 10: the higher the BAS-G score, the worse the participant’s health status. Correlation coefficient between change from baseline in WPAI-AS and BAS-G score at Month 6, 24 was reported.|Month 6, Month 24|FAS consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable at the specified time points for the given sub-scale items.||Correlation coefficient|||Number
693052|NCT01421303|Secondary|Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Global Score (BAS-G) at Baseline|WPAI-AS:6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment due to AS for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed(absenteeism), impairment while working(presenteeism), overall work impairment(work productivity), activity impairment(daily activity impairment). These sub-scores are transformed to impairment percentages(range 0 to 100), with higher numbers indicating greater impairment, less productivity. BAS-G is used to indicate the effect of disease on participant's well-being. This scale is composed of 2 items ranging from 0 = very good to 10 =very bad. Total score ranges from 0 to 10: the higher the BAS-G score, the worse the participant’s health status. Correlation coefficient between WPAI-AS and BAS-G score at baseline was reported.|Baseline|BAS consisted of all participants enrolled in the study, who were seen at baseline and started the treatment with etanercept (Enbrel). Here 'n' signifies those participants who were evaluable for the given scale item at baseline.||Correlation coefficient|||Number
693053|NCT01421303|Secondary|Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Metrology Index (BASMI) Total Score at Month 6 and 24|WPAI-AS:6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment due to AS for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed(absenteeism), impairment while working(presenteeism), overall work impairment(work productivity), activity impairment(daily activity impairment). These sub-scores are transformed to impairment percentages(range 0 to 100), with higher numbers indicating greater impairment, less productivity. BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Final score ranges from 0 to 10: the higher the BASMI score, the more severe the participant’s limitation of movement due to their AS. Correlation coefficient between change from baseline in WPAI-AS and BASMI score at Month 6, 24 was reported.|Month 6, Month 24|FAS consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable at the specified time points for the given sub-scale items.||Correlation coefficient|||Number
693054|NCT01421303|Secondary|Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Metrology Index (BASMI) Total Score at Baseline|WPAI-AS:6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment due to AS for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed(absenteeism), impairment while working(presenteeism), overall work impairment(work productivity), activity impairment(daily activity impairment). These sub-scores are transformed to impairment percentages(range 0 to 100), with higher numbers indicating greater impairment, less productivity. BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Final score ranges from 0 to 10: the higher the BASMI score, the more severe the participant’s limitation of movement due to their AS. Correlation coefficient between WPAI-AS and BASMI score at baseline was reported.|Baseline|BAS consisted of all participants enrolled in the study, who were seen at baseline and started the treatment with etanercept (Enbrel). Here 'n' signifies those participants who were evaluable for the given scale item at baseline.||Correlation coefficient|||Number
693055|NCT01421303|Secondary|Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Month 6 and 24|WPAI-AS:6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment due to AS for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed(absenteeism), impairment while working(presenteeism), overall work impairment(work productivity), activity impairment(daily activity impairment). These sub-scores are transformed to impairment percentages(range 0 to 100), with higher numbers indicating greater impairment, less productivity. BASFI:validated self-assessment tool to determine degree of functional limitation in AS. Utilizing a scale of 0-10(0=easy, 10=impossible),participants answered 10 questions assessing ability in completing normal daily activities/physically demanding activities. BASFI total score=mean score of 10 questions (range: 0 to 10, higher score=more severity). Correlation coefficient between change from baseline in WPAI-AS and BASFI score at Month 6, 24 was reported.|Month 6, Month 24|FAS consisted of all participants enrolled in the study, who were seen at visit 1 (baseline), started the treatment with etanercept and had at least one visit during follow-up. Here 'n' signifies those participants who were evaluable at specified time points for the given sub-scale items.||Correlation coefficient|||Number
693056|NCT01421303|Secondary|Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Baseline|WPAI-AS:6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment due to AS for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed(absenteeism), impairment while working(presenteeism), overall work impairment(work productivity), activity impairment(daily activity impairment). These sub-scores are transformed to impairment percentages(range 0 to 100), with higher numbers indicating greater impairment, less productivity. BASFI:validated self-assessment tool to determine degree of functional limitation in AS. Utilizing a scale of 0-10(0=easy, 10=impossible),participants answered 10 questions assessing ability in completing normal daily activities/physically demanding activities. BASFI total score=mean score of 10 questions (range: 0 to 10, higher score=more severity). Correlation coefficient between WPAI-AS and BASFI score at baseline was reported.|Baseline|BAS consisted of all participants enrolled in the study, who were seen at baseline and started the treatment with etanercept (Enbrel). Here 'n' signifies those participants who were evaluable for the given scale item at baseline.||Correlation coefficient|||Number
693057|NCT01421303|Secondary|Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at Month 6 and Month 24|WPAI-AS: 6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment attributable to AS for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism), overall work impairment (work productivity), activity impairment (daily activity impairment). These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity. BASDAI: validated self-assessment tool to determine disease activity in participants with AS. Utilizing a scale of 0-10 (0=none and 10=very severe), participants answered 6 questions measuring discomfort, pain, fatigue. The BASDAI total score averages the individual assessments and ranges from 0-10 (0=none, 10=very severe). Correlation coefficient between change from baseline in WPAI-AS and BASDAI score at Month 6 and 24 was reported.|Month 6, Month 24|FAS consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable at the specified time points for the given sub-scale items.||Correlation coefficient|||Number
693058|NCT01421303|Secondary|Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at Baseline|WPAI-AS: 6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment attributable to AS for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism), overall work impairment (work productivity), activity impairment (daily activity impairment). These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity. BASDAI: validated self-assessment tool to determine disease activity in participants with AS. Utilizing a scale of 0-10 (0=none and 10=very severe), participants answered 6 questions measuring discomfort, pain, fatigue. The BASDAI total score averages the individual assessments and ranges from 0-10 (0=none, 10=very severe). Correlation coefficient between WPAI-AS and BASDAI score at baseline was reported.|Baseline|BAS consisted of all participants enrolled in the study, who were seen at baseline and started the treatment with etanercept (Enbrel). Here 'n' signifies those participants who were evaluable for the given scale item at baseline.||Correlation coefficient|||Number
693059|NCT01421303|Secondary|Change From Baseline in Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 6 and 24|WPAI: AS is 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to ankylosing spondylitis (AS) for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism), overall work impairment (work productivity) and activity impairment (daily activity impairment). These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.|Baseline, Month 6, Month 24|FAS consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable at the specified time points for the given sub-scale items.||Percentage of impairment||Standard Deviation|Mean
693060|NCT01421303|Primary|Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 24|WPAI-AS is 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to ankylosing spondylitis for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.|Month 24|FAS consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable for the given sub-scale items at Month 24.||Percentage of impairment||Standard Deviation|Mean
693144|NCT01419769|Primary|Safety - Freedom From Major Complications: Perforation|Subjects are free of surgery for access-site related perforation|Through the duration of the 1-week post-stent removal study period|Intent-to-Treat population||percentage of patients|||Number
693061|NCT01421303|Primary|Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 18|WPAI-AS is 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to ankylosing spondylitis for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.|Month 18|FAS consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable for the given sub-scale items at Month 18.||Percentage of impairment||Standard Deviation|Mean
693062|NCT01421303|Primary|Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 12|WPAI-AS is 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to ankylosing spondylitis for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.|Month 12|FAS consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable for the given sub-scale items at Month 12.||Percentage of impairment||Standard Deviation|Mean
693063|NCT01421303|Primary|Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 6|WPAI-AS is 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to ankylosing spondylitis for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.|Month 6|Follow-up analysis set (FAS) consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable for the given sub-scale items at Month 6.||Percentage of impairment||Standard Deviation|Mean
693064|NCT01421303|Primary|Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores at Baseline|WPAI-AS is 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to ankylosing spondylitis for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.|Baseline|Baseline analysis set (BAS) consisted of all participants enrolled in the study, who were seen at baseline and started the treatment with etanercept (Enbrel). Here 'n' signifies those participants who were evaluable for the given sub-scale items at baseline.||Percentage of impairment||Standard Deviation|Mean
693065|NCT01421277|Primary|Main Reason for Stopping Triptan Use||Up to 3 months|All screened participants who were fully eligible for the study.||Number of partiicpants|||Number
693066|NCT01421277|Primary|Number of Participants Continuing Triptan Therapy|Participants reported information online. For this measure, the number of participants who continued to use a triptan after the first migraine attack were counted; switching from one triptan to another was considered continued use.|Up to 3 monoths|All screened participants who were fully eligible for the study.||Number of participants|||Number
693067|NCT01421277|Primary|Number of Participants Using a Triptan for Migraine Attacks|Participants reported information online. For this measure, the number of participants who used at least one dose of any newly prescribed triptan for the first time in response to a migraine attack were counted.|Up to 3 months|All screened participants who were fully eligible for the study.||Number of participants|||Number
693068|NCT01421147|Secondary|Rate Per 30 Days of Hypoglycemic Events|The rate of hypoglycemic events per 30 days is defined as the total number of events between visits divided by the actual number of days between visits, and then multiplied by 30 days. A hypoglycemic event is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia, or has blood glucose (BG) concentration of ≤ 70 milligrams/deciliter [mg/dL (3.9 millimoles/liter (mmol/L)], even if it was not associated with signs, symptoms, or treatment consistent with current guidelines (ADA 2005). Severe hypoglycemia is defined as a hypoglycemic event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions (these episodes may be associated with sufficient neuroglycopenia to induce seizure or coma; also, BG measurements may not be available during such an event). Nocturnal hypoglycemia is defined as any hypoglycemic event that occurs between bedtime and waking.|Baseline through 24 weeks (wk) and 52 weeks|All randomized participants who received at least 1 dose of study drug.||hypoglycemic events per 30 days||Standard Deviation|Mean
693069|NCT01421147|Secondary|Incidence of Hypoglycemic Events|Incidence of hypoglycemic events is defined as the number of hypoglycemic events. A hypoglycemic event is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia, or has a blood glucose (BG) concentration of ≤ 70 milligrams/deciliter [mg/dL (3.9 millimoles/liter (mmol/L)], even if it was not associated with signs, symptoms, or treatment consistent with current guidelines [American Diabetes Association (ADA) 2005]. Severe hypoglycemia is defined as a hypoglycemic event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions (these episodes may be associated with sufficient neuroglycopenia to induce seizure or coma; also, BG measurements may not be available during such an event). Nocturnal hypoglycemia is defined as any hypoglycemic event that occurs between bedtime and waking.|Baseline through 24 weeks (wk) and 52 weeks|All randomized participants who received at least 1 dose of study drug.||events|||Number
693070|NCT01421147|Secondary|Percentage of Participants With Hemoglobin A1c (HbA1c) <7.0% and HbA1c ≤6.5%|HbA1c is the glycosylated fraction of hemoglobin A which provides an estimate of a participant’s blood sugar control over a 6- to 12-week period. The percentage of participants with Hemoglobin A1c (HbA1c) <7.0% or HbA1c ≤6.5% is calculated as the number of participants with an HbA1c level of the cut-off value (<7.0% or ≤6.5%) divided by the number of participants treated, then multiplied by 100.|Baseline and 6 weeks and 12 weeks and 24 weeks and 36 weeks and 52 weeks and Endpoints (up to 24 weeks and up to 52 weeks)|All randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-baseline HbA1c measurement. Last observation carried forward (LOCF) principle was used for Endpoints (up to 24 weeks and up to 52 weeks).||percentage of participants|||Number
693071|NCT01421147|Secondary|Insulin Dose - Units [Total and by Component [Basal and Bolus (Lispro)])|Units of insulin taken daily were presented. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.|Endpoints [up to 24 weeks (wk) and up to 52 weeks]|All randomized participants who received at least 1 dose of study drug and had at least 1 insulin daily dose measurements. Last observation carried forward (LOCF) principle was used.||units of insulin per day (U/day)||Standard Error|Least Squares Mean
693072|NCT01421147|Secondary|Insulin Dose Per Body Weight (U/kg) (Total and by Component [Basal and Bolus (Lispro)])|Total daily insulin dose was adjusted for body weight [units of insulin/kilogram/day (U/kg/day)]. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.|Endpoints [up to 24 weeks (wk) and up to 52 weeks]|All randomized participants who received at least 1 dose of study drug and had at least 1 daily insulin dose per body weight measurements. Last observation carried forward (LOCF) principle was used.||U/kg/day||Standard Error|Least Squares Mean
693073|NCT01421147|Secondary|Insulin Treatment Satisfaction Questionnaire (ITSQ)|ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. Items measured on a 7-point scale: 1 (no bother at all) to 7 (a tremendous bother), with lower scores reflecting better outcomes. Items divided into 5 domains: Inconvenience of Regimen [(IR) 5 items: scores range 5-35], Lifestyle Flexibility [(LF) 3 items: scores range 3-21], Glycemic Control [(GC) 3 items: scores range 3-21], Hypoglycemic Control [(HC) 5 items: scores range 5-35], Insulin Delivery Device [(IDD) 6 items: scores range 6-42]. ITSQ Total Overall Scores range from 22-154. Data presented are the transformed score on a scale of 0-100, where transformed score=100×[(7-raw score)/6]. Higher scores indicate better treatment satisfaction. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.|Baseline and 24 weeks and Endpoint (up to 52 weeks)|All randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-baseline ITSQ measurements. Last observation carried forward (LOCF) principle was used for Endpoint (up to 52 weeks).||units on a scale||Standard Error|Least Squares Mean
693074|NCT01421147|Secondary|Adult Low Blood Sugar Survey (ALBSS)|"ALBSS contains 33 items, with each item scored on a 5-point response scale: 0 (never) to 4 (almost always). Items are categorized in 2 domains: Behavior (or avoidance) Items 1 to 15 and Worry (or affect) Items 16 to 33. Behavior Total Score (TS) range is 0 to 60 and Worry TS range is 0 to 72. Higher scores on Behavior items (related to avoidance of hypoglycemia) reflect greater awareness and/or effort of the participant to prevent low blood sugar. Higher scores on Worry items (related to worries about low blood sugar and its consequences) reflect greater participant concern about having low blood sugar. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country."|Baseline and 24 weeks and Endpoint (up to 52 weeks)|All randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-baseline ALBSS measurement. Last observation carried forward (LOCF) principle was used for Endpoint (up to 52 weeks).||units on a scale||Standard Error|Least Squares Mean
693075|NCT01421147|Secondary|Change From Baseline in Body Weight|Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.|Baseline, 6 weeks and 12 weeks and 18 weeks and Endpoints (up to 24 weeks and up to 52 weeks)|All randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-baseline body weight measurement. Last observation carried forward (LOCF) principle was used for Endpoints (up to 24 weeks and up to 52 weeks).||kilogram (kg)||Standard Error|Least Squares Mean
693076|NCT01421147|Secondary|Glycemic Variability of Fasting Blood Glucose|Glycemic variability is the intra-participant standard deviation (SD) value of fasting blood glucose as measured by the actual morning premeal blood glucose value from the 7-point self-monitoring blood glucose (SMBG) profiles. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.|Baseline and Endpoints (up to 24 weeks and up 52 weeks)|All randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-baseline fasting blood glucose measurement. Last observation carried forward (LOCF) principle was used.||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
698607|NCT01353963|Primary|Change From Baseline in Weight at Week 4.||Week 4|Safety population included all participants who received at least 1 dose of study medication during the observation period.||kilogram (kg)||Standard Deviation|Mean
693077|NCT01421147|Secondary|7-Point Self-Monitored Blood Glucose (SMBG) Profiles|7-point SMBG measurements are completed at the following timepoints: Morning (AM) Pre-Meal, AM Post-Prandial (PP), Midday (MD) Pre-Meal, MD PP, Evening (EV) Pre-Meal, Bed Time and 0300 hours. PP glucose is measured 2 hours (hrs) after the start of the meal. Values for the 7-point SMBG profiles were averaged over the three 7-point SMBG profiles during 2-week period prior to each visit. If only 1 of the 3 days of data was collected, then the value of the 1 day was used. If only 2 of the 3 days of data were collected, then the average of the 2 days was used. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.|Baseline and Endpoints [up to 24 weeks (wk) and up to 52 weeks]|All randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-baseline SMBG measurement. Last observation carried forward (LOCF) principle was used.||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
693078|NCT01421147|Secondary|Change From Baseline in Hemoglobin A1c (HbA1c)|HbA1c is the glycosylated fraction of hemoglobin A which provides an estimate of a participant’s blood sugar control over a 6- to 12-week period. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline HbA1c, treatment and time of basal insulin injection (daytime, evening/bedtime) and country.|Baseline, 6 weeks and 12 weeks and 24 weeks and 36 weeks and 52 weeks and Endpoint (up to 52 weeks)|All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline HbA1c measurements. Last observation carried forward (LOCF) principle was used for Endpoint (up to 52 weeks).||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
693079|NCT01421147|Secondary|Change From Baseline in Insulin Antibody Levels|Blood samples are collected from participants and percentage of insulin antibody binding was measured to determine the insulin antibody levels. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.|Baseline, 6 weeks and 12 weeks and Endpoints (up to 24 weeks and up to 52 weeks)|All randomized participants who received at least 1 dose of study drug and were insulin antibody positive at baseline and had at least 1 post-baseline insulin antibody positive measurement. Last observation carried forward (LOCF) principle was used for Endpoints (up to 24 and up to 52 weeks).||percentage of insulin antibody binding||Standard Error|Least Squares Mean
693080|NCT01421147|Primary|Change From Baseline up to 24 Weeks in Hemoglobin A1c (HbA1c)|HbA1c is the glycosylated fraction of hemoglobin A which provides an estimate of a participant’s blood sugar control over a 6- to 12-week period. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline HbA1c, treatment and time of basal insulin injection (daytime, evening/bedtime) and country.|Baseline, Endpoint (up to 24 weeks)|All randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-baseline HbA1c measurement. Last observation carried forward (LOCF) principle was used.||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
693081|NCT01421134|Secondary|Percentage of Subjects Who Achieve a Remission, Defined as a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of ≤ 12 at Week 6 (LOCF)||Baseline to Week 6|Intent to treat population||percentage of subjects|||Number
693082|NCT01421134|Secondary|Percentage of Subjects Who Achieve a Response, Defined as ≥ 50% Reduction From Baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 6 (LOCF).||Baseline to Week 6|Intent to treat population||percentage of subjects|||Number
693083|NCT01421134|Secondary|Mean Change From Baseline to Week 6 in the Hamilton Rating Scale for Anxiety(HAM-A) Total Score|The HAM-A is used to quantify the severity of anxiety symptomatology and consists of 14 items. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe/disabling). The HAM-A total score is calculated as the sum of the 14 individual items and ranges from 0 to 56. Higher scores are associated with greater degree of anxiety.|Baseline to Week 6|Intent to treat population. 3 Lurasidone subjects and 2 placebo subjects did not have post-baseline HAM-A assessment.||units on a scale||Standard Error|Least Squares Mean
693084|NCT01421134|Secondary|Mean Change From Baseline to Week 6 in the Sheehan Disability Scale (SDS) Total Score|The SDS is a composite of three self-rated items designed to measure the extent to which three major sectors (work/school, social life/leisure, and family life/home responsibility) in the patient’s life are impaired by depressive symptoms. These three items are responded to on a visual analogue scale (VAS) ranging through 0 (no impairment), 1–3 (mild), 4–6 (moderate), 7–9 (marked) and 10 (extreme) disability. The SDS total score is calculated as the sum of the three items and ranges from 0 (unimpaired) to 30 (highly impaired).|Baseline to Week 6|Intent to treat population: If a subject has not worked/studied at all during the past week for reasons unrelated to the disorder, the SDS total score will be set to missing.||units on a scale||Standard Error|Least Squares Mean
693085|NCT01421134|Secondary|Mean Change From Baseline to Week 6 in the Young Mania Rating Scale (YMRS) Total Score|The YMRS is an 11-item clinician-rated instrument used to assess the severity of mania. Seven items are rated on a 5-point scale, ranging from 0 to 4, and four items are rated on a 9-point scale, ranging from 0 to 8. The YMRS total score is calculated as the sum of the 11 individual items and ranges from 0 to 60. Higher scores are associated with greater severity of mania.|Baseline to Week 6|Intent to treat population||units on a scale||Standard Error|Least Squares Mean
693086|NCT01421134|Secondary|Mean Change From Baseline to the 6-week Study Endpoint in the Clinical Global Impression-Severity of Illness (CGI-S) Score|The CGI-S score is a single value, clinician-rated assessment of illness severity and ranges from 1= ‘Normal, not at all ill’ to 7= ‘Among the most extremely ill patients’. A higher score is associated with greater illness severity.|Baseline to Week 6|Intent to treat population||units on a scale||Standard Error|Least Squares Mean
693087|NCT01421134|Primary|Mean Change From Baseline to the 6-week Study Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Scores|The MADRS consists of 10 items, each rated on a Likert scale, from 0=”Normal” to 6=”Most Severe”. The MADRS total score is calculated as the sum of the 10 items. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity.|Baseline to Week 6|Intent to treat population||units on a scale||Standard Error|Least Squares Mean
693109|NCT01420081|Secondary|Terminal Elimination Half Life (t½) of PF-05212384 at Each Specified Time Points.||Pre-dose: 0 hours, and Post dose: 0.5 (after end of infusion), 1, 2, 4, 6, 24, 72, and 120 hours at Day 1|Participants were analyzed on PK parameter analysis set which was defined as all treated patients who had at least one of the PK parameters of interest estimated.||hours||Standard Deviation|Mean
693093|NCT01420848|Secondary|Students Anxiety Levels|The State-Trait Anxiety Inventory consists of 2 scales, each one containing 20 items. One of the scales evaluates state anxiety, characterized by subjective feelings of tension and apprehension, followed by autonomic nervous system responses at a given moment. Trait anxiety, assessed by the other scale, refers to a relatively stable tendency to perceive situations at threatening and react anxiously to them. The scores are divided into low, moderate, high and very high and are determined by the sum of 20 symptoms from a 5-point Likert-type scale.The range of scores is 20-80, the higher the score indicating greater anxiety for both the Trait and State Anxiety.|90 days|It was analysed only the number of participants that ended the study.||units on a scale||Standard Deviation|Mean
693094|NCT01420848|Primary|Students Stress Levels|The List of Symptoms of Stress is an evaluation questionnaire which consists of a list of 59 psycho-physiological and psychosocial stress, in which the subject must associate to each symptom of the four answers: never (0), rarely (1 ), often (2) or always (3). The scores are added together and the answers provide the level of stress the individual.In this questionnaire to score from 0 to 11 is void, 12 to 29 (low level), 30 to 59 (medium level), 60 to 120 (high level) and 120 to 177, very high level. Participants below 29 points were excluded.|90 days|It was analysed only the subjects that ended the study.||units on a scale||Standard Deviation|Mean
693095|NCT01420289|Secondary|Wound Pain as Determined by a Visual Analog 10 Point Scale (VAS) for Pain.|Percent change (improvement)in mean VAS pain scores at baseline and at 16 weeks|16 weeks|||Percent improvement in mean VAS pain sco||Standard Error|Mean
693096|NCT01420289|Secondary|Perceived Improvement in Physical Function After 16 Weeks|"Percent improvement in SF-36 Quality of life (QOL) questionnaire score at baseline and at week-16.
The higher the score on the SF-36 questionnaire the better the QOL."|16 weeks|||Percent improvement in Sf-36 QOL score||Standard Error|Mean
693097|NCT01420289|Secondary|Percent Improvement in Peak Walking Time|Percentage Improvement in the amount of time one can walk without pain|16 weeks|||Percentage Change||Standard Error|Mean
693098|NCT01420289|Primary|Mean Percent Reduction in Wound Surface Area||baseline and 16 weeks|||Percent reduction in wound surface area||Standard Error|Mean
693099|NCT01420146|Secondary|HER2 Extracellular Domain|evaluate the concentration of circulating HER2 extracellular domain in the blood and study his possible role as on imaging quality|within 60 min before tracer injection||||||
693100|NCT01420146|Secondary|Time Activity Curve|Time activity curve of normal organ and tumor lesions: pharmacokinetic|blood sample at 5, 15, 30, 60 minutes, 1 day, 2 days and 4 or 6 days after tracer injection. Images : Day 0, Day 2 and Day 4 or 6||||||
693101|NCT01420146|Primary|Test the Diagnostic Accuracy of the HER2 Imaging Using the Labelled Monoclonal Antibody Trastuzumab by Correlating the HER2 PET/CT Imaging With the FDG-PET/CT and Molecular Characterization of Tumor Samples With Discordant Image Findings|A visual ‘patient-based’ classification capturing the whole disease burden was developed by using a side-by-side display, comparing baseline FDG–PET/CT(showing all FDG-positive mets independent of their HER2-imaging status) & day4 HER2–PET/CT. Pts were grouped into 4 HER2–PET/CT patterns according to the proportion of FDG avid tumour load showing relevant 89Zr-T uptake. Pattern A: entire tumor load showed pertinent tracer uptake; B: dominant part of tumour load showed tracer uptake; C: minor part of tumor load showed tracer uptake; D: entire tumor load lacked tracer uptake. Patterns A+B='HER2-positive’ & C+D=‘HER2-negative’. In the 20 pts: 4 pts were classified “A”, 5“B”, 1“C” & 10“D”. This classification indicates substantial heterogeneity of 89Zr-T uptake within this so called ‘HER2-positive’ pt population. After dichotomization, 11(55%) pts were considered as HER2–PET/CT negative. Furthermore, HER2–PET/CT revealed intrapatient heterogeneity of tumour uptake(pts classified B or C).|4 years|||Participants|||Count of Participants
693102|NCT01420081|Secondary|Summary of Treatment-related TEAEs|"Safety of subject in terms of number of participants with treatment related AEs.
Note: One subject treated with PF-05212384 had the stathmin status changed after randomization and was categorized under the corresponding arm."|From baseline (-3 days) until 35 days post last dose|Participants were analyzed on safety analysis set which was defined as all enrolled patients who started treatment.||Number of participants|||Number
693103|NCT01420081|Secondary|Number of Treatment-related TEAEs|"Safety of subject in terms of number of participants with treatment related AEs.
Note: One subject treated with PF-05212384 had the stathmin status changed after randomization and was categorized under the corresponding arm."|From baseline (-3 days) until 35 days post last dose|Participants were analyzed on safety analysis set which was defined as all enrolled patients who started treatment.||Number of AEs|||Number
693104|NCT01420081|Secondary|Summary of Treatment-emergent Adverse Events (TEAEs) - All Causalities|Safety of participants in terms of TEAEs. Note: One subject treated with PF-05212384 had the stathmin status changed after randomization and was categorized under the corresponding arm.|From baseline (-3 days) until 35 days post last dose|Participants were analyzed on safety analysis set which was defined as all enrolled patients who started treatment.||Number of participants|||Number
693105|NCT01420081|Secondary|Number of Treatment-emergent Adverse Events (TEAEs) - All Causalities|Safety of participants in terms of TEAEs. Note: One subject treated with PF-05212384 had the stathmin status changed after randomization and was categorized under the corresponding arm.|From baseline (-3 days) until 35 days post last dose|Participants were analyzed on safety analysis set which was defined as all enrolled patients who started treatment.||Number of AEs|||Number
693106|NCT01420081|Secondary|Steady State Volume of Distribution (Vss) of PF-05212384 at Each Specified Time Points.||Pre-dose: 0 hours, and Post dose: 0.5 (after end of infusion), 1, 2, 4, 6, 24, 72, and 120 hours|Participants were analyzed on PK parameter analysis set which was defined as all treated patients who had at least one of the PK parameters of interest estimated.||Litres||Geometric Coefficient of Variation|Geometric Mean
693107|NCT01420081|Secondary|Clearance (CL) of PF-05212384 at Each Specified Time Points.||Pre-dose: 0 hours, and Post dose: 0.5 (after end of infusion), 1, 2, 4, 6, 24, 72, and 120 hours at Day 1|Participants were analyzed on PK parameter analysis set which was defined as all treated patients who had at least one of the PK parameters of interest estimated.||L/hr||Geometric Coefficient of Variation|Geometric Mean
693108|NCT01420081|Secondary|Time for Cmax (Tmax) of PF-05212384 at Each Specified Time Points.||Pre-dose: 0 hours, and Post dose: 0.5 (after end of infusion), 1, 2, 4, 6, 24, 72, and 120 hours at Day 1|Participants were analyzed on PK parameter analysis set which was defined as all treated patients who had at least one of the PK parameters of interest estimated.||hours||Full Range|Median
693111|NCT01420081|Secondary|Area Under the Serum Concentration Time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PF-05212384 at Each Specified Time Points.||Pre-dose: 0 hours, and Post dose: 0.5 (after end of infusion), 1, 2, 4, 6, 24, 72, and 120 hours at Day 1|Participants were analyzed on PK parameter analysis set which was defined as all treated patients who had at least one of the PK parameters of interest estimated.||ng.hr/mL||Geometric Coefficient of Variation|Geometric Mean
693112|NCT01420081|Secondary|Area Under the Serum Concentration Time Profile From Time Zero Extrapolated to Infinity (AUCinf) of PF-05212384 at Each Specified Time Points.||Pre-dose: 0 hours, and Post dose: 0.5 (after end of infusion), 1, 2, 4, 6, 24, 72, and 120 hours at Day 1|Participants were analyzed on PK parameter analysis set which was defined as all treated patients who had at least one of the PK parameters of interest estimated.||ng.hr/mL||Geometric Coefficient of Variation|Geometric Mean
693113|NCT01420081|Secondary|Percentage of Participants in Each Treatment Arm With Gene and/or Protein Expression Biomarkers- PIK3CA Amplification, KRAS Mutation P/N, KRAS Mutation OBSV, PTEN Stroma Manual Score, PTEN Tumor Manual Score, KRAS SCC and Stathmin H/L,Tissue.|"Gene and/or protein expression biomarkers in biopsied tumor tissue relating to PI3K and/or mTOR pathway activation, such as PIK3CA and PIK3R1 mutations, Phosphatase And Tensin Homolog (PTEN) protein levels, and PIK3CA gene amplification were to be assessed.
Stained tissues were evaluated by a board-certified pathologist who provided a manual pathology score (i.e., 0, 1+, 2+, or 3+) and, if appropriate, comments upon the staining of the specimen.
The directionality increases from 0 to 3+ with 0 being no staining for PTEN by IHC and 3+ being high staining intensity for PTEN."|Baseline and Cycle1 to Cycle 5 where each cycle consist of 28 days|Participants were analyzed as the molecular profiling tumor analysis set was defined as all enrolled patients who started treatment and had baseline tumor tissues (archived paraffin block or unstained slides or fresh tumor tissue sample) successfully analyzed for at least one of the biomarkers.||Percentage of participants|||Number
693114|NCT01420081|Secondary|Stathmin H Score [Mean (SD)] for Each Treatment Arm With Gene and/or Protein Expression Biomarkers in Biopsied Tumor Tissue|"Gene and/or protein expression biomarkers in biopsied tumor tissue relating to PI3K and/or mTOR pathway activation, such as PIK3CA and PIK3R1 mutations, PTEN protein levels, and PIK3CA gene amplification were to be assessed.
Each slide was imaged by whole slide scanning and patient samples were scored as follows:
Pathologist manual score (0, 1+, 2+, 3+) for overall staining intensity of tumor tissue.
Percentage of positive tumor cells staining at 0, 1+, 2+, and 3+.
H-score value (integer between 0 and 300) for tumor cell staining was calculated. The higher the stathmin staining, the higher the stathmin H-score."|Prior to Cycle 1 Day 1|Participants were analyzed as the molecular profiling tumor analysis set was defined as all enrolled patients who started treatment and had baseline tumor tissues (archived paraffin block or unstained slides or fresh tumor tissue sample) successfully analyzed for at least one of the biomarkers.||Score||Standard Deviation|Mean
693115|NCT01420081|Secondary|Level of Each Pharmacodynamic Parameter at Specified Timepoints- Triglycerides (mg/dL)|PD biomarkers are measured at screening (baseline) and multiple time points post baseline. Baseline is defined as the last measurement prior to dosing, which is the measurement at screening or the cycle 1 day 1 pre-dose measurement if collected. This outcome measure will be updated once the data is available with the supplemental clinical study report.|Baseline (Day -3) and Cycle1 to Cycle 3 where each cycle consist of 28 days|Participants were analyzed on PD analysis set which consisted of all enrolled patients who started treatment and had a baseline as well as at least one post-baseline measurement for at least one PD biomarker. The PD biomarkers include serum glucose, insulin, HbA1c, cholesterol, and triglycerides.||Triglycerides (mg/dL)||Standard Deviation|Mean
693116|NCT01420081|Secondary|Level of Each Pharmacodynamic Parameter at Specified Timepoints- Cholesterol (mg/dL)|PD biomarkers are measured at screening (baseline) and multiple time points post baseline. Baseline is defined as the last measurement prior to dosing, which is the measurement at screening or the cycle 1 day 1 pre-dose measurement if collected. This outcome measure will be updated once the data is available with the supplemental clinical study report.|Baseline (Day -3) and Cycle1 to Cycle 3 where each cycle consist of 28 days|Participants were analyzed on PD analysis set which consisted of all enrolled patients who started treatment and had a baseline as well as at least one post-baseline measurement for at least one PD biomarker. The PD biomarkers include serum glucose, insulin, HbA1c, cholesterol, and triglycerides.||Cholesterol (mg/dL)||Standard Deviation|Mean
693117|NCT01420081|Secondary|Level of Each Pharmacodynamic Parameter at Specified Timepoints- Glycosylated Hemoglobin (HbA1c)|PD biomarkers are measured at screening (baseline) and multiple time points post baseline. Baseline is defined as the last measurement prior to dosing, which is the measurement at screening or the cycle 1 day 1 pre-dose measurement if collected. This outcome measure will be updated once the data is available with the supplemental clinical study report.|Baseline (Day -3) and Cycle1 to Cycle 5 where each cycle consist of 28 days|participants were analyzed on PD analysis set which consisted of all enrolled patients who started treatment and had a baseline as well as at least one post-baseline measurement for at least one PD biomarker. The PD biomarkers include serum glucose, insulin, HbA1c, cholesterol, and triglycerides.||HbA1c (mg/dL)||Standard Deviation|Mean
693118|NCT01420081|Secondary|Level of Each Pharmacodynamic Parameter at Specified Timepoints- Insulin (UIU/mL)|PD biomarkers are measured at screening (baseline) and multiple time points post baseline. Baseline is defined as the last measurement prior to dosing, which is the measurement at screening or the cycle 1 day 1 pre-dose measurement if collected. This outcome measure will be updated once the data is available with the supplemental clinical study report.|Baseline (Day -3) and Cycle1 to Cycle 5 where each cycle consist of 28 days|Participants were analyzed on PD analysis set which consisted of all enrolled patients who started treatment and had a baseline as well as at least one post-baseline measurement for at least one PD biomarker. The PD biomarkers include serum glucose, insulin, HbA1c, cholesterol, and triglycerides.||Insulin (UIU/mL)||Standard Deviation|Mean
693145|NCT01419769|Primary|Safety - Freedom From Major Complications: Access Site-related Infection|Subjects are free of access site-related infection requiring intravenous or intramuscular antibiotics and/or extended hospitalization|Through the duration of the 1-week post-stent removal study period|Per protocol population||percentage of patients|||Number
693146|NCT01419769|Secondary|Clinical Success|Clinical success is defined as at least a 50% decrease in pseudocyst size, based on radiographic analysis, at 30 days and/or 60 days.|Up to 60 days|Patients treated per protocol.||percentage of patients|||Number
693119|NCT01420081|Secondary|Level of Each Pharmacodynamic Parameter at Specified Timepoints- Glucose (mg/dL)|PD biomarkers are measured at screening (baseline) and multiple time points post baseline. Baseline is defined as the last measurement prior to dosing, which is the measurement at screening or the cycle 1 day 1 pre-dose measurement if collected. This outcome measure will be updated once the data is available with the supplemental clinical study report.|Baseline (Day -3) and Cycle1 to Cycle 5 where each cycle consist of 28 days|Participants were analyzed on PD analysis set which consisted of all enrolled patients who started treatment and had a baseline as well as at least one post-baseline measurement for at least one PD biomarker. The PD biomarkers include serum glucose, insulin, HbA1c, cholesterol, and triglycerides.||Glucose (mg/dL)||Standard Deviation|Mean
693120|NCT01420081|Secondary|Overall Survival (OS) for PF-05212384|OS is defined as the time from the date of Cycle 1 Day 1 to the date of death.|12 months|Survival analysis was not performed as the study was terminated early. No data are available because data were not collected. The LIC reporting arm were not a part of the per protocol analysis set for summarizing response.|||||
693121|NCT01420081|Secondary|Percentage of Participants With Progression Free Survival (PFS) at 6 Months for PF-05212384|Progression free survival is defined as the time from the date of cycle 1 day 1 to the date that objective progressive disease is documented or death due to any cause, whichever occurs first. PFS was characterized in terms of the probability of remaining progression-free at 6 months (based on Kaplan-Meier estimates). Progression is defined using RECIST v1.1, as a 20% increase in the sum of the longest diameter of target lesions with a minimum absolute increase of 5 mm, or an unequivocal progression of non-target lesion, or the appearance of new lesions.|6 months|Per protocol dataset included participants enrolled for treatment, with baseline tumor, measurable disease and with disease under study. The LIC reporting arm were not a part of the per protocol analysis set for summarizing response.||Percentage of participants||95% Confidence Interval|Number
693122|NCT01420081|Secondary|Progression Free Survival for PF-05212384|PFS is defined as the time from the date of cycle 1 day 1 to the date that objective progressive disease is documented or death due to any cause, whichever occurs first. PFS was characterized in terms of the median. Approximate 95% confidence interval corresponding to this estimate was computed. Progression is defined using RECIST v1.1, as a 20% increase in the sum of the longest diameter of target lesions with a minimum absolute increase of 5 mm, or an unequivocal progression of non-target lesion, or the appearance of new lesions.|From Cycle 1 Day 1 to objective progressive disease or death due to any cause whichever occurs first (up to 12 months)|Per protocol dataset included participants enrolled for treatment, with baseline tumor, measurable disease and with disease under study. The LIC reporting arm were not a part of the per protocol analysis set for summarizing response.||Days||95% Confidence Interval|Median
693123|NCT01420081|Secondary|Progression Free Survival for PF-04691502|PFS is defined as the time from the date of cycle 1 day 1 to the date that objective progressive disease is documented or death due to any cause, whichever occurs first. PFS was characterized in terms of the median. Approximate 95% confidence interval corresponding to this estimate was computed. Progression is defined using RECIST v1.1, as a 20% increase in the sum of the longest diameter of target lesions with a minimum absolute increase of 5 mm, or an unequivocal progression of non-target lesion, or the appearance of new lesions. On 09 Oct 2012, Pfizer decided to stop enrollment into PF-04691502. While tumor assessment for PF-04691502 was included as a listing in the final report, formal efficacy analysis for PF-04691502 was not performed.|From Cycle 1 Day 1 to objective progressive disease or death due to any cause whichever occurs first (up to 12 months)|Per protocol dataset included participants enrolled for treatment, with baseline tumor, measurable disease and with disease under study. The LIC reporting arm were not a part of the per protocol analysis set for summarizing response.||Time to Event (Days)|||Number
693124|NCT01420081|Secondary|Percentage of Participants With Objective Response for PF-05212384|Objective response is defined as CR or PR. CR: Complete response: 2 or more objective statuses of CR a minimum of 4 weeks apart documented before PD. Partial response: 2 or more objective statuses of PR or better a minimum of 4 weeks apart documented before PD, but not qualifying as CR. Per RECIST v1.1 for target lesions: CR defined as disappearance of all target lesions; PR defined as >=30% decrease in the sum of the longest diameter of target lesions.|Randomization to objective progression, death or last tumor assessment without progression (up to 12 months)|Per protocol dataset included participants enrolled for treatment, with baseline tumor, measurable disease and with disease under study. The LIC reporting arm were not a part of the per protocol analysis set for summarizing response.||Percentage of participants||95% Confidence Interval|Number
693125|NCT01420081|Secondary|Objective Response for PF-04691502|"Objective response is defined as CR or PR. CR: Complete response: 2 or more objective statuses of CR a minimum of 4 weeks apart documented before PD. Partial response: 2 or more objective statuses of PR or better a minimum of 4 weeks apart documented before PD, but not qualifying as CR. Per RECIST v1.1 for target lesions: CR defined as disappearance of all target lesions; PR defined as >=30% decrease in the sum of the longest diameter of target lesions. The outcome data table below presents the number of participants with objective response as yes or no. On 09 Oct 2012, Pfizer decided to stop enrollment into PF-04691502. While tumor assessment for PF-04691502 was included as a listing in the final report, formal efficacy analysis for PF-04691502 was not performed."|Randomization to objective progression, death or last tumor assessment without progression (up to 12 months)|Per protocol dataset included participants enrolled for treatment, with baseline tumor, measurable disease and with disease under study. The LIC reporting arm were not a part of the per protocol analysis set for summarizing response.||Participants response|||Number
693147|NCT01419769|Secondary|Effectiveness: Technical Success|Placement of the AXIOS Stent using the AXIOS Delivery System and removal of the AXIOS Stent using a standard endoscopic snare.|Up to 60 days|Intent-to-Treat population||participants|||Number
693148|NCT01419769|Secondary|Effectiveness: Stent Removability at 30 Days and/or 60 Days|AXIOS stent removal was indicated at the time of pseudocyst resolution (≤ 3 cm diameter) or at 60 the day post procedure visit. Scheduled examination for pseudocyst resolution was designated at 30 days for removal if the pseudocyst resolution criterion was met. Otherwise, the stent was left in place for removal at the 60 day visit.|Up to 60 days|Patients who had AXIOS stent successfully placed during index procedure.||percentage of patients|||Number
693149|NCT01419769|Secondary|Effectiveness: Stent Lumen Patency at 30 Days and/or 60 Days|Stent lumen patency at 30 days and/or 60 days.|Up to 60 days|Patients treated per protocol with successful stent placement.||percentage of patients|||Number
693126|NCT01420081|Primary|Percentage of Participants With Clinical Benefit Response for PF-05212384|Clinical benefit response was defined as best overall response of complete response (CR), partial response (PR) or stable disease (SD) for at least 16 weeks from Cycle 1 Day 1 (C1D1) to the first time of disease progression. The primary analysis is based on the clinical benefit rate which is calculated as proportion of participants with a clinical benefit response relative to total number of response evaluable participants. Per RECIST v1.1 for target lesions: CR defined as disappearance of all target lesions; PR defined as >=30% decrease in the sum of the longest diameter of target lesions; SD does not qualify for CR, PR or Progression. All target lesions must be assessed. SD can follow PR only in the rare case that the sum increases by less than 20% from the nadir, but enough that a previously documented 30% decrease no longer holds. A Clopper-Pearson exact 95% CI for the clinical benefit rate is presented in the below table.|16 weeks from Cycle 1 Day 1|Per protocol dataset included participants enrolled for treatment, with baseline tumor, measurable disease and with disease under study. The LIC reporting arm were not a part of the per protocol analysis set for summarizing response.||Percentage of participants||95% Confidence Interval|Number
693127|NCT01420081|Primary|Clinical Benefit Response for PF-04691502|"Clinical benefit response was defined as best overall response of complete response (CR), partial response (PR) or stable disease (SD) for at least 16 weeks from Cycle 1 Day 1 (C1D1) to the first time of disease progression. The outcome data table below presents the number of participants with clinical benefit response as yes or no. On 09 Oct 2012, Pfizer decided to stop enrollment into PF-04691502. While tumor assessment for PF-04691502 was included as a listing in the final report, formal efficacy analysis for PF-04691502 was not performed."|16 weeks from Cycle 1 Day 1|Per protocol dataset included participants enrolled for treatment, with baseline tumor, measurable disease and with disease under study. The LIC reporting arm were not a part of the per protocol analysis set for summarizing response.||Participants|||Number
693128|NCT01419977|Primary|Change in Clinical Pain Scores|The primary pain assessment tool will be a 10-cm horizontal visual analog scale (VAS), with “0” corresponding to no pain at one end and “10” indicating the worst pain at the other.|Baseline to day 3|9 subjects were discharged prior to obtaining day 3 VAS score.||units on a scale||Standard Deviation|Mean
693129|NCT01419977|Primary|Change in Thrombin Generation Assay - Endogenous Thrombin Potential|Patients will have thrombin generation assay samples drawn on Day 1 and 3|Day 1 and Day 3|9 subjects were discharged prior to day 3 so the day 3 blood sample was not obtained.||nM||Standard Deviation|Mean
693130|NCT01419977|Primary|Change in Clinical Pain Scores|The primary pain assessment tool will be a 10-cm horizontal visual analog scale (VAS), with “0” corresponding to no pain at one end and “10” indicating the worst pain at the other.|Baseline to day 1|||units on a scale||Standard Deviation|Mean
693131|NCT01419977|Primary|Change in D-dimer|Patients will have D-dimer,for samples drawn on Day 1 and Day 3|Day 1 and Day 3|9 subjects were discharged prior to day 3 so the day 3 blood sample was not obtained.||ng/mL||Standard Deviation|Mean
693132|NCT01419795|Secondary|Donor and Host Polymorphisms of the FCgamma RIIIa Receptor and Their Impact on Disease Response and Relapse||Baseline, day 7 and 28 of course 1, and day 28 of course 3|With only 3 participants enrolled to the first arm, meaningful comparisons could not be made and data for this objective was not collected.|||||
693133|NCT01419795|Secondary|Pharmacokinetics of Rituximab: Evaluation of Serum Concentrations and Correlations to Drug Dose and Clinical Responses||Baseline, day 7 and 28 of course 1, and day 28 of course 3|With only 3 participants enrolled to the first arm, meaningful comparisons could not be made and data for this objective was not collected.|||||
693134|NCT01419795|Secondary|Comparison of Incidences of Adverse Events Between the First, Second, and Third Cohorts||Assessed up to 30 days after completion of study treatment|No participants enrolled in the second arm. Not enough participants in first arm to make meaningful comparisons to historic controls.||Number of adverse events|||Number
693135|NCT01419795|Secondary|Changes in Plasma Cytokines and Peripheral Blood Lymphocytes in Correlation to Treatment With Lenalidomide||From baseline to day 28 of course 3|With only 3 participants enrolled to the first arm, meaningful comparisons could not be made and data for this objective was not collected.|||||
693136|NCT01419795|Secondary|Comparison of Rates of Overall Response and Complete Remission Between the First, Second, and Third Cohorts||Assessed up to 18 months|No participants enrolled in the second arm. Not enough participants in first arm to make meaningful comparisons to historic controls.||Participants|||Count of Participants
693137|NCT01419795|Secondary|Incidences of Grades II-IV Acute GVHD and Limited or Extensive Chronic GVHD||Assessed up to 30 days after completion of study treatment|No participants enrolled in the second arm.||Participants|||Count of Participants
693138|NCT01419795|Secondary|Grade III-IV Toxicity in Patients Receiving Lenalidomide With or Without Rituximab||Assessed up to 30 days after completion of study treatment|No participants enrolled in the second arm.||Participants|||Count of Participants
693139|NCT01419795|Secondary|Rate of Response (CR, PR, or SD) and Time to Progression|Estimated using the Kaplan-Meier method in all cohorts. Assessed at day 100.|Assessed up to 18 months|No participants enrolled in the second arm.||progression free survival probability||95% Confidence Interval|Number
693140|NCT01419795|Primary|Improvement in Overall Survival of Patients Receiving Lenalidomide With or Without Rituximab in Comparison to Historical Controls Managed by Single or Multiple Chemotherapeutic Agents or Donor Lymphocyte Infusion (DLI) (Cohort 1)|Estimated using the Kaplan-Meier method in all cohorts.|12 months|Primary objective could not be completed because there were no patients enrolled in the second experimental arm (lenalidomide). Additionally, having only three patients in one arm does not allow for a meaningful comparison to historic controls.||survival probability||95% Confidence Interval|Number
693141|NCT01419769|Primary|Safety - Freedom From Major Complications: SAE's|Treated subjects are free of serious adverse event classified as implant-associated or implant/endoscopic procedure-associated.|Through the duration of the 1-week post-stent removal study period|Intent-to-Treat population||percentage of patients|||Number
693142|NCT01419769|Primary|Safety - Freedom From Major Complications: Tissue Injury|Subjects are free of tissue injury (ulceration to the submucosa) at stent site persisting through 1-week post-stent removal.|Through the duration of the 1-week post-stent removal study period|Per protocol population||percentage of patients|||Number
693150|NCT01419769|Primary|Safety - Freedom From Major Complications: Access Site-related Bleeding|Subjects are free of access site-related bleeding requiring transfusion|Through the duration of the 1-week post-stent removal study period|Intent-to-Treat population||percentage of patients|||Number
693152|NCT01419639|Secondary|Audiologic Response|"Defined as improvement in speech discrimination score (SDS), defined as an improvement in the score above the 95% critical difference threshold, compared to baseline audiogram at initiation of treatment. Audiologic worsening: decrease in SDS score below the 95% critical difference threshold, compared to baseline audiogram at initiation of treatment.
Patients with vestibular schwannomas will receive baseline audiograms within 28 days before enrollments and subsequent audiograms at the time of each MRI."|1 Year|||participants|||Number
693153|NCT01419639|Primary|Radiographic Response|To estimate the objective response rates to RAD001 in patients with NF2-related tumors including cranial nerve schwannomas, meningiomas and ependymomas. Radiographic response for study purposes = greater than or equal to 15% reduction in tumor volume in any of the target tumors (partial response). Complete disappearance of any of the target tumors = complete response. MRI of the brain and spine will be performed every 3 months. If an objective response (15% reduction in tumor volume compared to baseline) is observed in any target tumor or stable disease, drug will be continued.|1 Year|||participants|Tumors||Number
693154|NCT01419314|Secondary|Function-Walking Distance|"Six minute walk test
For this test the participants were instructed to: Please walk as far, as fast and as safe as you can for up to six minutes. The walking test will be performed in a climate-controlled environment, on a level surface void of obstacles and with a pre-determined path of 68 feet (or approximately 20 m) per lap. The beginning and end of the 34-foot path were clearly marked with taped trapezoids to the non-skid floor."|week 6|The number of participants returning for the 6 week follow-up||Meters (m)||Standard Deviation|Mean
693155|NCT01419314|Secondary|Function-Walking Distance|"Six minute walk test
For this test the participants were instructed to: Please walk as far, as fast and as safe as you can for up to six minutes. The walking test will be performed in a climate-controlled environment, on a level surface void of obstacles and with a pre-determined path of 68 feet (or approximately 20 m) per lap. The beginning and end of the 34-foot path were clearly marked with taped trapezoids to the non-skid floor."|week 3|The number of participants returning for the 3 week follow-up with complete data||Meters (m)||Standard Deviation|Mean
693156|NCT01419314|Primary|Sleep Quality/Quantity Scores (PSQI)|The Pittsburgh Sleep Quality Index (PSQI) is a ten item questionnaire, covering the following seven components of sleep: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunctions. Buysse et al. reported sensitivity and specificity values of 89.6% and 86.5%, respectively for this scale in identifying good and poor sleepers.|week 6|The number of participants returning for the second follow-up||Scores ranging 0-21, 0=no disturbances||Standard Deviation|Mean
693157|NCT01419314|Primary|Sleep Quality/Quantity Scores (PSQI)|The Pittsburgh Sleep Quality Index (PSQI) is a ten item questionnaire, covering the following seven components of sleep: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunctions.|week 3|The number of participants returning for the first follow-up with complete data.||Scores ranging 0-21, 0=no disturbances||Standard Deviation|Mean
693158|NCT01419314|Secondary|Function-Reach|"Forward reach test
For this test, the investigators asked the participants to stand next to a wall without shoes and with their feet positioned hip-width apart on the floor with one shoulder close to the wall. The participants were instructed to reach as far forward as possible, without losing your balance, touching the wall or stepping and crossing the tile threshold on the floor. The average distance of three reaching attempts was recorded and used in the analysis."|week 6|The number of participants returning for the first follow-up. One participant in the liner group had baseline scores greater than 3 standard deviation difference from the mean and was excluded from the analysis.||Centimeters (cm)||Standard Deviation|Mean
693159|NCT01419314|Secondary|Function-Reach|"Forward reach test
For this test, the investigators asked the participants to stand next to a wall without shoes and with their feet positioned hip-width apart on the floor with one shoulder close to the wall. The participants were instructed to reach as far forward as possible, without losing your balance, touching the wall or stepping and crossing the tile threshold on the floor. The average distance of three reaching attempts was recorded and used in the analysis."|week 3|The number of participants returning for the first follow-up. One participant in the liner group had baseline scores greater than 3 standard deviation difference from the mean and was excluded from the analysis.||Centimeters (cm)||Standard Deviation|Mean
693160|NCT01419314|Primary|Pain Scores|A composite pain score was collected using the self-reported Neuropathic Pain Scale (NPS). In this zero to 100 scale, the participant is asked to quantify the different aspects of the pain experience in the presence of neuropathies.|Week 6|The total number of participants that completed the 6 week trial in each investigational group||units on a scale 0-100 (0=no pain)||Standard Deviation|Mean
693161|NCT01419314|Primary|Pain Scores at Week 3|A composite pain score was collected using the self-reported Neuropathic Pain Scale (NPS). In this zero to 100 scale, the participant is asked to quantify the different aspects of the pain experience in the presence of neuropathies.|Week 3|The total number of participants returning for the first follow-up at week three with complete data.||units on a scale 0-100 (0= no pain)||Standard Deviation|Mean
693162|NCT01419275|Primary|Percentage of Regions With Collateral Versus Antegrade Blood Flow (Sensitivity) Correctly Identified Using MRI With Xenon Contrast Agent (Specificity)|Sensitivity and specificity for MRI-based ASL measure of presence of collaterals was measured using digital subtraction angiography as a gold standard. Measurements were for 20 regions per patient were scored as either positive or negative for collateral flow. A positive value (results) means the region is supplied by collateral flow. Negative means the region is supplied by antegrade (normal) flow. Sensitivity measures the proportion of positives that are correctly identified as such. Specificity measures the proportion of negatives that are correctly identified as such.|performed one time within 1 week prior to surgery|One participant did not undergo MRI and was not included in the analysis.||percentage of regions|Cerebral regions|95% Confidence Interval|Number
693199|NCT01419171|Secondary|12 Month Non-cardiac Death Rate||Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months|12-Month rates: the percentage of patients who experience an event through 365 days post-procedure out of the patients who have either had an event within 365 days post-procedure or who were event-free with last follow-up at least 335 days post-procedure.||percentage of participants||95% Confidence Interval|Number
698608|NCT01353963|Primary|Change From Baseline in Heart Rate at Week 8.||Week 8|Safety population included all participants who received at least 1 dose of study medication during the observation period.||bpm||Standard Deviation|Mean
693163|NCT01419249|Primary|Height Velocity Standard Deviation Score (SDS) at Year 1|Height velocity SDS was calculated as height velocity minus reference mean height velocity divided by standard deviation of the reference population. Height velocity SDS reflects the height velocity relative to a reference population of the same age and gender. Height velocity SDS at Year 1 was one of the growth parameter to assess the first year growth response to r-hGH treatment.|Year 1|FAS population included all the participants who had provided informed consent and had non-missing height at start (defined as within one month prior to treatment start date) and at 1 year (+/- 120 days) of r-hGH treatment and had pharmacogenomics data available.||standard deviation score||Standard Deviation|Mean
693164|NCT01419249|Primary|Change From Baseline in Height Standard Deviation Score (SDS) at Year 1|Height SDS was calculated as height minus reference mean height divided by standard deviation of the reference population. Height SDS reflects the height relative to a reference population of the same age and gender. Change from baseline in height SDS at Year 1 was one of the growth parameter to assess the first year growth response to r-hGH treatment.|Baseline and Year 1|FAS population included all the participants who had provided informed consent and had non-missing height at start (defined as within one month prior to treatment start date) and at 1 year (+/- 120 days) of r-hGH treatment and had pharmacogenomics data available.||standard deviation score||Standard Deviation|Mean
693165|NCT01419249|Secondary|Evaluation of the Contribution of Validated Genetic Markers to the Amplitude of First Year Growth Response to r-hGH Therapy in TS Girls Using Turner Syndrome Kabi-Pharmacia International Growth Study (TS KIGS) Predictive Model|TS KIGS predictive model includes various clinical, auxological and biological markers which are as follows: maximum GH response to provocation test; age at onset of therapy; birth weight SDS; average GH dose received during the first year of r-hGH therapy; height SDS at start of therapy; the difference between the pre-treatment height SDS of the subject and the mid parental height SDS; and weight SDS at start of therapy.|Year 1|No genetic markers were identified during the study therefore, the data for this outcome measure was not analyzed.|||||
693166|NCT01419249|Secondary|Evaluation of the Contribution of Validated Genetic Markers to the Amplitude of First Year Growth Response to r-hGH Therapy in IGHD Children Using Growth Hormone Deficiency Kabi-Pharmacia International Growth Study (GHD KIGS) Predictive Model|GHD KIGS predictive model includes various clinical, auxological and biological markers which are as follows: maximum growth hormone (GH) response to provocation test; age at onset of therapy; birth weight SDS; average GH dose received during the first year of r-hGH therapy; height SDS at start of therapy; the difference between the pre-treatment height SDS of the subject and the mid parental height SDS; and weight SDS at start of therapy.|Year 1|No genetic markers were identified during the study therefore, the data for this outcome measure was not analyzed.|||||
693167|NCT01419249|Primary|Change From Baseline in Height at Year 1|Change from baseline in height at year 1 was one of the growth parameter to assess the first year growth response to r-hGH treatment.|Baseline and Year 1|FAS population included all the participants who had provided informed consent and had non-missing height at start (defined as within one month prior to treatment start date) and at 1 year (+/- 120 days) of r-hGH treatment and had pharmacogenomics data available.||centimeter||Standard Deviation|Mean
693168|NCT01419236|Secondary|Change From Baseline in MSHQ-EjD-SF Bother/Satisfaction Score at 16 Weeks|"The MSHQ-EjD-SF was a 4 item, self-reported questionnaire used for the assessment of EjD during the past month. The MSHQ-EjD-SF Bother/Satisfaction Score was based on Q4: If you have had any ejaculation difficulties or have been unable to ejaculate, have you been bothered by this? Scores ranged from 0 (no problem with ejaculation), 1 (not at all bothered) to 5 (extremely bothered). LS mean of change from baseline was calculated using MMRM including treatment, visit, treatment-by-visit interaction, region, baseline total testosterone level (≥200 ng/dL vs. <200 ng/dL), baseline ED severity (normal, mild, moderate, severe), and centered baseline Bother/Satisfaction Score as fixed effects, and unstructured covariance structure for modeling correlation."|Baseline, 16 weeks|Randomized participants who received at least 1 dose of study drug and completed the MSHQ-EjD-SF questionnaire at least once post-baseline.||units on a scale||Standard Error|Least Squares Mean
693169|NCT01419236|Secondary|Change From Baseline in the International Index of Erectile Function (IIEF)-Orgasmic Function Domain Score at 16 Weeks|IIEF: 15 item, self-reported questionnaire assessing overall erectile function and satisfaction during past month. Orgasmic Function Domain Score: sum of IIEF scores for Q9 and Q10. In Q9, participants (pts) identified how often they ejaculated when having sexual stimulation or intercourse. In Q10, pts identified how often they had a feeling of an orgasm with or without ejaculation when having sexual stimulation or intercourse. For each Q, scores ranged from 0 (no sexual stimulation or intercourse), 1 (almost never or never) to 5 (almost always or always). Total Orgasmic Function Domain Scores ranged from 0 to 10. LS mean of change from baseline calculated using MMRM including treatment, visit, treatment-by-visit interaction, region, baseline total testosterone level (≥200 ng/dL vs. <200 ng/dL), baseline ED severity (normal, mild, moderate, severe), and centered baseline Orgasmic Function Domain Score as fixed effects, and unstructured covariance structure for modeling correlation.|Baseline, 16 weeks|Randomized participants who received at least 1 dose of study drug and completed the MSHQ-EjD-SF questionnaire at least once post-baseline.||units on a scale||Standard Error|Least Squares Mean
693170|NCT01419236|Secondary|Change From Baseline in Sexual Activity Log: Orgasmic Pleasure at 16 Weeks|The sexual activity log was used by study participants to document ejaculatory functioning and orgasmic pleasure for each sexual activity attempt over 4 weeks. Reported is orgasmic pleasure rated from 0 (no pleasure) to 10 (excellent). LS mean of change from baseline was calculated using MMRM including treatment, visit, treatment-by-visit interaction, region, baseline total testosterone level (≥200 ng/dL vs. <200 ng/dL), baseline ED severity (normal, mild, moderate, severe), and centered baseline orgasmic pleasure as fixed effects, and unstructured covariance structure for modeling correlation.|Baseline, 16 weeks|Randomized participants who received at least 1 dose of study drug and completed the MSHQ-EjD-SF questionnaire at least once post-baseline.||units on a scale||Standard Error|Least Squares Mean
693200|NCT01419171|Secondary|12 Month Cardiac Death Rate||Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months|12-Month rates: the percentage of patients who experience an event through 365 days post-procedure out of the patients who have either had an event within 365 days post-procedure or who were event-free with last follow-up at least 335 days post-procedure.||percentage of participants||95% Confidence Interval|Number
703386|NCT00094900|Secondary|Mean Change in C-Reactive Protein||3 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||mg/dl||Standard Error|Mean
693171|NCT01419236|Secondary|Change From Baseline in Sexual Activity Log: Frequency of Sexual Attempts at 16 Weeks|The sexual activity log was used by study participants to document ejaculatory functioning and orgasmic pleasure for each sexual activity attempt over 4 weeks. Ejaculatory functioning included perceived volume of ejaculate, perceived force of ejaculation, delayed ejaculation, and frequency. Reported is the change from baseline number of sexual attempts at 16 weeks. LS mean of change from baseline was calculated using an analysis of covariance (ANCOVA) including treatment group, region, baseline total testosterone level, baseline ED severity (normal, mild, moderate, severe) as fixed effects, and centered baseline as a covariate.|Baseline, up to 16 weeks|Randomized participants who received at least 1 dose of study drug and completed the MSHQ-EjD-SF questionnaire at least once post-baseline; Last observation carried forward (LOCF).||sexual attempts||Standard Error|Least Squares Mean
693172|NCT01419236|Secondary|Change From Baseline in Sexual Activity Log: Delayed Ejaculation at 16 Weeks|The sexual activity log was used by study participants to document ejaculatory functioning and orgasmic pleasure for each sexual activity attempt over 4 weeks. Ejaculatory functioning included perceived volume of ejaculate, perceived force of ejaculation, delayed ejaculation, and frequency. Reported is delayed ejaculation rated from 0 (did not ejaculate) to 10 (optimal/best ejaculate time). LS mean of change from baseline was calculated using MMRM including treatment, visit, treatment-by-visit interaction, region, baseline total testosterone level (≥200 ng/dL vs. <200 ng/dL), baseline ED severity (normal, mild, moderate, severe), and centered baseline delayed ejaculation as fixed effects, and unstructured covariance structure for modeling correlation.|Baseline, 16 weeks|Randomized participants who received at least 1 dose of study drug and completed the MSHQ-EjD-SF questionnaire at least once post-baseline.||units on a scale||Standard Error|Least Squares Mean
693173|NCT01419236|Secondary|Change From Baseline in Sexual Activity Log: Perceived Force of Ejaculation at 16 Weeks|The sexual activity log was used by study participants to document ejaculatory functioning and orgasmic pleasure for each sexual activity attempt over 4 weeks. Ejaculatory functioning included perceived volume of ejaculate, perceived force of ejaculation, delayed ejaculation, and frequency. Reported is the perceived force of ejaculation rated from 0 (could not ejaculate) to 10 (strong ejaculation). LS mean of change from baseline was calculated using MMRM including treatment, visit, treatment-by-visit interaction, region, baseline total testosterone level (≥200 ng/dL vs. <200 ng/dL), baseline ED severity (normal, mild, moderate, severe), and centered baseline perceived force of ejaculation as fixed effects, and unstructured covariance structure for modeling correlation.|Baseline, 16 weeks|Randomized participants who received at least 1 dose of study drug and completed the MSHQ-EjD-SF questionnaire at least once post-baseline.||units on a scale||Standard Error|Least Squares Mean
693174|NCT01419236|Secondary|Change From Baseline in Sexual Activity Log: Perceived Volume of Ejaculate at 16 Weeks|The sexual activity log was used by study participants to document ejaculatory functioning and orgasmic pleasure for each sexual activity attempt over 4 weeks. Ejaculatory functioning included perceived volume of ejaculate, perceived force of ejaculation, delayed ejaculation, and frequency. Reported is the perceived volume of ejaculate rated from 0 (no ejaculate) to 10 (high volume of ejaculate). LS mean of change from baseline was calculated using MMRM including treatment, visit, treatment-by-visit interaction, region, baseline total testosterone level (≥200 ng/dL vs. <200 ng/dL), baseline ED severity (normal, mild, moderate, severe), and centered baseline ejaculatory volume as fixed effects, and unstructured covariance structure for modeling correlation.|Baseline, 16 weeks|Randomized participants who received at least 1 dose of study drug and completed the MSHQ-EjD-SF questionnaire at least once post-baseline.||units on a scale||Standard Error|Least Squares Mean
693175|NCT01419236|Secondary|Change From Baseline in Ejaculate Volume at 16 Weeks|The change from baseline in ejaculate volume was determined by actual measurement of semen volume in milliliters (mL). LS mean of change from baseline was calculated using MMRM including treatment, visit, treatment-by-visit interaction, region, baseline total testosterone level (≥200 ng/dL vs. <200 ng/dL), baseline ED severity (normal, mild, moderate, severe), and centered baseline ejaculatory volume as fixed effects, and unstructured covariance structure for modeling correlation.|Baseline, 16 weeks|Randomized participants who received at least 1 dose of study drug and completed the MSHQ-EjD-SF questionnaire at least once post-baseline.||mL||Standard Error|Least Squares Mean
693176|NCT01419236|Primary|Change From Baseline in the Male Sexual Health Questionnaire-Ejaculatory Dysfunction-Short Form (MSHQ-EjD-SF) Ejaculatory Function Score at 16 Weeks|MSHQ-EjD-SF: 4 item, self-reported questionnaire assessing ejaculatory dysfunction. MSHQ-EjD-SF Ejaculatory Function Score: sum of scores for questions (Q)1 through Q3 about frequency and strength of ejaculations and volume of ejaculate for sexual activity attempts during past month. Ejaculation frequency was rated 1 (could not ejaculate) to 5 (all the time); strength and volume from 0 (could not ejaculate) to 5 (as strong/much as it always has been). Total Ejaculatory Function Score ranged from 1 to 15. Least-squares (LS) mean of change from baseline calculated using repeated measures mixed‐effects model (MMRM) including treatment, visit, treatment-by-visit interaction, region, baseline total testosterone level [≥200 nanograms per deciliter (ng/dL) versus (vs.) <200 ng/dL], baseline erectile dysfunction (ED) severity (normal, mild, moderate, severe), and centered baseline ejaculatory function score as fixed effects, and unstructured covariance structure for modeling correlation.|Baseline, 16 weeks|Randomized participants who received at least 1 dose of study drug and completed the MSHQ-EjD-SF questionnaire at least once post-baseline.||units on a scale||Standard Error|Least Squares Mean
693177|NCT01419197|Secondary|6-month and 1-year Survival (Final Analysis)|6-month and 1-year survival were defined as the percentage of participants who were alive at 6 months and 1 year, respectively, as estimated using Kaplan-Meier method.|Baseline to the clinical cut-off date of 13 Feb 2015 (up to 4 years)|Randomized population: All participants who were randomized to the study. Participants were included in the treatment group to which they were randomized.||Percentage of participants||95% Confidence Interval|Number
693178|NCT01419197|Secondary|Overall Survival (Final Analysis)|Overall survival was defined as the time from randomization to death from any cause.|Baseline to the clinical cut-off date of 13 Feb 2015 (up to 4 years)|Randomized population: All participants who were randomized to the study. Participants were included in the treatment group to which they were randomized.||Months||95% Confidence Interval|Median
693232|NCT01417936|Secondary|Time to Reach Minimum Serum Concentration (Tmin)||Pre-treatment, 1, 2, 4, 8, 24, and 48 hours post-infusion at Week 0 and Week 3|The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment. ‘n’ signifies subjects who were evaluable at given time points.||hour||Standard Deviation|Mean
693179|NCT01419197|Secondary|Change From Baseline in the EORTC QLQ-BM22 Pain Score on Day 1 of Each Cycle|The EORTC QLQ-BM22 assesses the symptoms of bone metastases using 22 items: 5 items for sites of pain, 3 pain characteristics, 8 functional interference aspects, and 6 psychosocial aspects. The pain score was derived from the 3 pain characteristic items. Each item was rated on a 4-point scale, where 1=Not at all to 4=Very much. The pain score was the sum of the 3 pain characteristic scores and was normalized to a scale of 0 to 100. A higher score indicates greater pain. A negative change score indicates improvement.|Baseline to the clinical cut-off date of 11 Feb 2013 (up to 2 years)|Randomized population: All participants who were randomized to the study. Only participants with a Baseline pain score and at least 1 post-baseline pain score were included in the analysis. Participants were included in the treatment group to which they were randomized.||Units on a scale||Standard Deviation|Mean
693180|NCT01419197|Secondary|Time to Pain Symptom Progression|Time to pain symptom progression was defined as the time from randomization to the first documentation of an increase in narcotic use and/or a 10 point increase from Baseline in the pain score as measured by the European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire for patients with bone metastases (EORTC QLQ-BM22). The EORTC QLQ-BM22 assesses the symptoms of bone metastases using 22 items: 5 items for sites of pain, 3 pain characteristics, 8 functional interference aspects, and 6 psychosocial aspects. The pain score was derived from the 3 pain characteristic items. Each item was rated on a 4-point scale, where 1=Not at all to 4=Very much. The pain score was the sum of the 3 pain characteristic scores and was normalized to a scale of 0 to 100. A higher score indicates greater pain.|Baseline to the clinical cut-off date of 11 Feb 2013 (up to 2 years)|Randomized population: All participants who were randomized to the study. Only participants with a Baseline pain score and at least 1 post-baseline pain score were included in the analysis. Participants were included in the treatment group to which they were randomized.||Months||95% Confidence Interval|Median
693181|NCT01419197|Secondary|6-month and 1-year Survival|6-month and 1-year survival were defined as the percentage of participants who were alive at 6 months and 1 year, respectively, as estimated using Kaplan-Meier method.|Baseline to the clinical cut-off date of 11 Feb 2013 (up to 2 years)|Randomized population: All participants who were randomized to the study. Participants were included in the treatment group to which they were randomized.||Percentage of participants||95% Confidence Interval|Number
693182|NCT01419197|Secondary|Duration of the Objective Response|Duration of the objective response was defined as the time from the first tumor assessment that was judged to indicate that the patient had an objective response to the time of first documented disease progression using RECIST v1.1 per investigator assessment or death from any cause, whichever occurred first.|Baseline to the clinical cut-off date of 11 Feb 2013 (up to 2 years)|Randomized population: All participants who were randomized to the study. Only participants with an objective response were included in the analysis. Participants were included in the treatment group to which they were randomized.||Months||95% Confidence Interval|Median
693183|NCT01419197|Secondary|Percentage of Participants With an Objective Response|An objective response was defined as a complete or partial response determined on 2 consecutive occasions ≥ 4 weeks apart using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Complete response was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must be < 10 mm on the short axis. Partial response was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum. Participants who had no post-baseline tumor assessment were counted as non-responders.|Baseline to the clinical cut-off date of 11 Feb 2013 (up to 2 years)|Randomized population: All participants who were randomized to the study. Only participants with measurable disease at Baseline were included in the analysis. Participants were included in the treatment group to which they were randomized.||Percentage of participants||95% Confidence Interval|Number
693184|NCT01419197|Primary|Overall Survival|Overall survival (OS) was defined as the time from randomization to death from any cause. Overall survival was a co-primary endpoint.|Baseline to the clinical cut-off date of 11 Feb 2013 (up to 2 years)|Randomized population: All participants who were randomized to the study. Participants were included in the treatment group to which they were randomized.||Months||95% Confidence Interval|Median
693185|NCT01419197|Primary|Progression-free Survival|Progression-free survival was defined as the time from randomization to the first documented disease progression by investigator assessment using Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 or death from any cause, whichever occurred first. Progression-free survival was a co-primary endpoint.|Baseline to the clinical cut-off date of 11 Feb 2013 (up to 2 years)|Randomized population: All participants who were randomized to the study. Participants were included in the treatment group to which they were randomized.||Months||95% Confidence Interval|Median
693186|NCT01419184|Secondary|cSSSI-related Medical Resource Utilization and Costs|Direct medical costs were based on utilization of health resources. Unit cost data were obtained from sources external to the trial and assigned to corresponding medical resource utilization observed within the trial to estimate costs of care. cSSSI-related costs were reported from a societal perspective, and further broken down into a health care system perspective. The health care system perspective includes hospital and outpatient costs. The societal perspective includes the health care system perspective plus participant and caregiver time loss from work and participant and caregiver out-of-pocket expenses. Total cost (including both total inpatient and total post-discharge costs) per participant is presented.|Baseline (Day 0) through 30 days post hospital discharge|The primary analytic sample (subset of the entire sample) comprised participants receiving at least 1 dose of study drug with complete data to calculate the primary outcome, IRLOS.||dollars (United States)||Standard Deviation|Mean
693187|NCT01419184|Secondary|30-day cSSSI-related Hospital Readmission Rates|Hospital readmission rates were defined as readmission to an inpatient hospital facility within 30 days of hospital discharge for management of cSSSI relapse or treatment of adverse events related to cSSSI treatment. It did not include all-cause readmissions (for completeness, all-cause readmissions are reported in the descriptive tables). Participants were asked if they had been readmitted to the hospital since their discharge and whether the admission was specifically for their skin infection. The number of participants who were re-hospitalized for skin infection or side effects due to skin infection medication within 30 days since the initial hospital discharge (Day 14) is presented.|End of Hospital Stay (up to Day 14) through 30 days post hospital discharge|The primary analytic sample (subset of the entire sample) comprised participants receiving at least 1 dose of study drug with complete data to calculate the primary outcome, IRLOS.||participants|||Number
693188|NCT01419184|Secondary|Participant Global Impression of Improvement (PGI-I) at Hospital Discharge|PGI-I assessments of improvement were measured by asking participants: How is your skin infection today compared to how it was yesterday? Scores were calculated based on response to the single item, where 1 = improved a lot; 2 = improved moderately; 3 = improved a little; 4 = no change; 5 = worsened a little; 6 = worsened moderately; 7 = worsened a lot. Mean PGI-I scores are presented at hospital discharge; lower values represent greater improvement.|End of Hospital Stay (up to Day 14)|The primary analytic sample (subset of the entire sample) comprised participants receiving at least 1 dose of study drug with complete data to calculate the primary outcome, IRLOS. Participants also had evaluable PGI-I data at hospital discharge.||units on a scale||Standard Deviation|Mean
693189|NCT01419184|Secondary|Mean Change From Baseline to Hospital Discharge in Participant-reported Health-related Quality of Life (HRQoL)|Health-related quality of life (HRQoL) was measured using the EuroQol-5 Dimensions, 5 Level (EQ-5D-5L) multi-attribute questionnaire. The 5 dimensions measured were: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant's health state was expressed by a descriptive profile of a 5 digit number. The EQ-5D health states were converted into a single summary index (from 0 to 1, with 0 representing death, to 1 representing perfect health) by applying weights to each of the levels in each dimension. Change from baseline to hospital discharge is presented; positive values represent an increase in health utility.|Baseline (Day 0), End of Hospital Stay (up to Day 14)|The primary analytic sample (subset of the entire sample) comprised participants receiving at least 1 dose of study drug with complete data to calculate the primary outcome, IRLOS. Participants also had evaluable EQ-5D data at baseline and at hospital discharge.||units on a scale||Standard Deviation|Mean
693190|NCT01419184|Secondary|Mean Change From Baseline to Hospital Discharge in Pain According to the Brief Pain Inventory-Short Form (BPI-SF)|Pain was measured as the amount of pain experienced “right now” by the participant using an 11-point numerical rating scale adapted from Brief Pain Inventory-Short Form (BPI-SF). Participants were asked to rate pain in his or her skin infection from 0 to 10, where 0 is no pain and 10 is pain as bad as he or she could imagine. Change from baseline to hospital discharge is presented; a negative value represents a decrease in pain.|Baseline (Day 0), End of Hospital Stay (up to Day 14)|The primary analytic sample (subset of the entire sample) comprised participants receiving at least 1 dose of study drug with complete data to calculate the primary outcome, IRLOS. Participants also had evaluable BPI-SF data at baseline and at hospital discharge.||units on a scale||Standard Deviation|Mean
693191|NCT01419184|Primary|Infection-Related Hospital Length of Stay|Infection Related Hospital Length of Stay (IRLOS) is defined as the number of hours of hospitalization associated with antibiotic treatment of the complicated skin and skin structure infections (cSSSI) beginning at initiation of study-antibiotic administration and ending at discontinuation of all antibiotic therapy for cSSSI or at hospital discharge (whichever occurred first). This included continued hospitalization for treatment of adverse events resulting from use of the study antibiotic or subsequent antimicrobial therapy. The mean number of hours for each treatment group is presented.|Baseline (Day 0) through the End of Hospital Stay (up to Day 14)|The primary analytic sample (subset of the entire sample) comprised participants receiving at least 1 dose of study drug with complete data to calculate the primary outcome, IRLOS. As the end of the IRLOS depended upon the participant’s course of treatment, no static set of items were answered to determine if a participant had complete data.||Hours||Standard Deviation|Mean
693192|NCT01419171|Secondary|Clinical Procedural Success Rate|Clinical Procedural Success: lesion diameter stenosis < 30% in 2 near-orthogonal projections with TIMI 3 flow, as visually assessed by the physician, without the occurrence of in-hospital MI, TVR, or cardiac death. Summarized per patient.|Participants will be followed for the duration of hospital stay, an expected average of 1 day|||percentage of patients||95% Confidence Interval|Number
693193|NCT01419171|Secondary|Periprocedural Endpoints: Technical Success Rate|Technical success: successful delivery and deployment of the study stent to the target vessel, without balloon rupture or embolization. Summarized per attempted study stent.|Participants will be followed for the duration of hospital stay, an expected average of 1 day|||percentage of patients|Participants|95% Confidence Interval|Number
693194|NCT01419171|Secondary|12 Month Stent Thrombosis Rate (Definite or Probable by Academic Research Consortium [ARC] Definitions)||Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months|12-Month rates: the percentage of patients who experience an event through 365 days post-procedure out of the patients who have either had an event within 365 days post-procedure or who were event-free with last follow-up at least 335 days post-procedure.||percentage of participants||95% Confidence Interval|Number
693195|NCT01419171|Secondary|12 Month All Death/MI/TVR Rate||Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months|12-Month rates: the percentage of patients who experience an event through 365 days post-procedure out of the patients who have either had an event within 365 days post-procedure or who were event-free with last follow-up at least 335 days post-procedure.||percentage of participants||95% Confidence Interval|Number
693196|NCT01419171|Secondary|12 Month All Death or MI Rate||Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months|12-Month rates: the percentage of patients who experience an event through 365 days post-procedure out of the patients who have either had an event within 365 days post-procedure or who were event-free with last follow-up at least 335 days post-procedure.||percentage of participants||95% Confidence Interval|Number
693197|NCT01419171|Secondary|12 Month Cardiac Death or MI Rate||Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months|12-Month rates: the percentage of patients who experience an event through 365 days post-procedure out of the patients who have either had an event within 365 days post-procedure or who were event-free with last follow-up at least 335 days post-procedure.||percentage of participants||95% Confidence Interval|Number
693198|NCT01419171|Secondary|12 Month All Death Rate||Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months|12-Month rates: the percentage of patients who experience an event through 365 days post-procedure out of the patients who have either had an event within 365 days post-procedure or who were event-free with last follow-up at least 335 days post-procedure.||percentage of participants||95% Confidence Interval|Number
698609|NCT01353963|Primary|Change From Baseline in Heart Rate at Week 4.||Week 4|Safety population included all participants who received at least 1 dose of study medication during the observation period.||beats per minute (bpm)||Standard Deviation|Mean
693201|NCT01419171|Secondary|12 Month Myocardial Infarction (MI)(Q-wave and Non-Q-wave) Rate||Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months|12-Month rates: the percentage of patients who experience an event through 365 days post-procedure out of the patients who have either had an event within 365 days post-procedure or who were event-free with last follow-up at least 335 days post-procedure.||percentage of participants||95% Confidence Interval|Number
693202|NCT01419171|Secondary|12 Month Target Vessel Failure (TVF) Rate|Target vessel failure is any ischemia-driven revascularization of the target vessel, MI (Q-wave and non–Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.|Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months|12-Month rates: the percentage of patients who experience an event through 365 days post-procedure out of the patients who have either had an event within 365 days post-procedure or who were event-free with last follow-up at least 335 days post-procedure.||percentage of participants||95% Confidence Interval|Number
693203|NCT01419171|Secondary|12 Month Target Vessel Revascularization (TVR) Rate||Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months|12-Month rates: the percentage of patients who experience an event through 365 days post-procedure out of the patients who have either had an event within 365 days post-procedure or who were event-free with last follow-up at least 335 days post-procedure.||percentage of participants||95% Confidence Interval|Number
693204|NCT01419171|Secondary|12 Month Target Lesion Revascularization (TLR) Rate|Any ischemia-driven repeat percutaneous coronary intervention (PCI), to improve blood flow, of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.|Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months|12-Month rates: the percentage of patients who experience an event through 365 days post-procedure out of the patients who have either had an event within 365 days post-procedure or who were event-free with last follow-up at least 335 days post-procedure.||percentage of participants||95% Confidence Interval|Number
693205|NCT01419171|Primary|9-month Target Lesion Failure (TLF) Rate|The primary endpoint is 9-month target lesion failure (TLF) rate, defined as any ischemia-driven revascularization of the target lesion (TLR), Myocardial Infarction (MI) (Q-wave and non-Q-wave) related to the target vessel, or cardiac death.|Nine Month|N=323 (5 patients were not evaluable for the endpoint: Follow-up < 240 days and event-free)||percentage of participants||95% Confidence Interval|Number
693206|NCT01419028|Secondary|Invasive Ventilator-free Survival Time|Invasive ventilator-free survival is defined as the time during which the patient is alive and not invasively ventilated. For the purpose of this study, invasive ventilation is defined as mechanical ventilation via intubation of trachaeostomy.|Retrospective data collected on or before the date of abstraction.|||days||95% Confidence Interval|Median
693207|NCT01419028|Primary|Survival|Overall survival is defined as the time from birth to time of death.|Retrospective data collected on or before the data of abstraction.|||days||95% Confidence Interval|Median
693208|NCT01418937|Primary|Number of Pregnant Subjects Reporting Pregnancy Outcomes|The pregnancy outcomes were based on reports from pregnant subjects in the study population. Pregnancy outcomes are pregnancies resulting in live births.|Throughout the study period (from Month 0 up to Month 12)|The analysis was performed on the number of pregnant subjects participating in the study.||Subjects|||Number
693209|NCT01418937|Primary|Number of Subjects With Medically Significant Conditions (MSCs)|MSCs include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|Throughout the study period (from Month 0 up to Month 12)|The analysis was based on the Total Vaccinated cohort, which included all subjects with the study vaccine administered||Subjects|||Number
693210|NCT01418937|Primary|Number of Subjects With Potential Immune-mediated Disease (pIMDs)||Throughout the study period (from Month 0 up to Month 12)|The analysis was based on the Total Vaccinated cohort, which included all subjects with the study vaccine administered||Subjects|||Number
693211|NCT01418937|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Throughout the study period (from Month 0 up to Month 12)|The analysis was based on the Total Vaccinated cohort, which included all subjects with the study vaccine administered||Subjects|||Number
693212|NCT01418703|Secondary|Mean Glucose|Average plasma glucose concentration in mg/dl|Throughout each 22-hour closed-loop and open-loop admission for sCTR and eCTR|||mg/dL||Standard Deviation|Mean
693213|NCT01418703|Secondary|Percent Time Spent in Near Normoglycemia|Comparison of time spent in near normoglycemia (3.9 to 10 mmol/mL) in open-loop vs closed-loop sCTR and eCTR.|Throughout each 22-hour closed-loop and open-loop admission for sCTR and eCTR|||percentage of time||Standard Deviation|Mean
693214|NCT01418703|Primary|Hypoglycemic Events|Number of hypoglycemic events below 70 mg/dL per patient per day|Throughout each 22-hour closed-loop and open-loop admission for sCTR and eCTR|||events/admission per patient||Standard Deviation|Mean
693215|NCT01418482|Secondary|Pain|To evaluate pain during dressing removal at visit 4,(after one week) with John Hopkins pain scale. Measured 0=no pain, 100= worst pain, scale from 0-100 mm|3 weeks|||units on a scale||Inter-Quartile Range|Median
693216|NCT01418482|Secondary|Evaluate the Comfort|Comfort level and overall experience were each assessed using a scale that ranged from very poor to very good.|3 weeks|||participants|||Number
693217|NCT01418482|Primary|Evaluate the Experience of Using Mepilex Border Ag ( a Silver Dressing) in Normal Clinical Practice|burns healed|3 weeks|small thickness partial burns||burns healed|||Number
693218|NCT01418365|Primary|Maximum Plasma Concentration (Cmax) at Steady State for Metronidazole|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Assessed over a 24-hour period starting post-dose on day 4|Pharmacokinetic Analysis Set||ng/ml||Standard Deviation|Mean
703387|NCT00094900|Secondary|Mean Change in Serum Amyloid A||24 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||mg/liter||Standard Error|Mean
693219|NCT01418365|Primary|Area Under the Plasma Concentration Curve (AUC) at Steady State for Metronidazole|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Assessed over a 24-hour period starting post-dose on day 4|Pharmacokinetic Analysis Set defined as all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. The Safety Analysis Set consists of subjects who took at least 1 dose of investigational product and had at least 1 postdose safety assessment.||ng*h/ml||Standard Deviation|Mean
693220|NCT01418209|Secondary|Perceived Hot Flash Interference (Hot Flash Related Daily Interference Scale; HFRDIS) -- Week 8|The perceived hot flash related daily interference scale (HFRDIS) is a tool for assessing the impact of hot flashes on quality of life. There are 10 questions with each having a score ranging from 0 to 10. The scores from each question are summed for a total score ranging from 0 to 100. Lower numbers indicate less interference and higher numbers indicate more interference.|Week 8|Intention-to-treat, i.e., all participants with follow-up data were included.||units on a scale||95% Confidence Interval|Mean
693221|NCT01418209|Secondary|Perceived Hot Flash Interference (Hot Flash Related Daily Interference Scale; HFRDIS) -- Week 4|The perceived hot flash related daily interference scale (HFRDIS) is a tool for assessing the impact of hot flashes on quality of life. There are 10 questions with each having a score ranging from 0 to 10. The scores from each question are summed for a total score ranging from 0 to 100. Lower numbers indicate less interference and higher numbers indicate more interference.|Week 4|Intention-to-treat, i.e., all participants with follow-up data were included.||units on a scale||95% Confidence Interval|Mean
693222|NCT01418209|Secondary|Bothersomeness of Hot Flashes -- Week 8|Measured by self-report diary twice daily (day and night) for 7 days. Bothersomeness ratings ranged from 0 to 3 with lower numbers being less bothersome and higher numbers being more bothersome. Data from the day and night bothersomeness ratings were averaged for a single daily score. The single daily scores for the week prior to the week 8 study assessment were summed and averaged to produce a mean daily VMS bothersomeness for week 8.|Week 8|Intention-to-treat, i.e., all participants with follow-up data were included.||units on a scale||95% Confidence Interval|Mean
693223|NCT01418209|Secondary|Bothersomeness of Hot Flashes -- Week 4|Measured by self-report diary twice daily (day and night) for 7 days. Bothersomeness ratings ranged from 0 to 3 with lower numbers being less bothersome and higher numbers being more bothersome. Data from the day and night bothersomeness ratings were averaged for a single daily score. The single daily scores for the week prior to the week 4 study assessment were summed and averaged to produce a mean daily VMS bothersomeness for week 4.|Week 4|Intention-to-treat, i.e., all participants with follow-up data were included.||units on a scale||95% Confidence Interval|Mean
693224|NCT01418209|Primary|Frequency of Hot Flashes (Daily Vasomotor Symptom [VMS] Frequency) -- Week 8|Measured by self-report diary twice daily (day and night). The day and night frequencies were summed to produce a single number of hot flashes per day. The single number of hot flashes per day were summed and averaged for one week prior to the week 8 study assessment to produce a mean daily frequency for week 8.|Week 8|Intention-to-treat, i.e., all participants with follow-up data were included.||number of hot flashes per day||95% Confidence Interval|Mean
693225|NCT01418209|Secondary|Severity of Hot Flashes -- Week 8|Measured by self-report diary twice daily (day and night) for 7 days. Severity ratings ranged from 0 to 3 with lower numbers being less severe and higher numbers being more severe. Data from the day and night severity ratings were averaged for a single daily score. The single daily scores for the week prior to the week 8 study assessment were summed and averaged to produce a mean daily VMS severity for week 8.|Week 8|Intention-to-treat, i.e., all participants with follow-up data were included.||units on a scale||95% Confidence Interval|Mean
693226|NCT01418209|Secondary|Severity of Hot Flashes -- Week 4|Measured by self-report diary twice daily (day and night) for 7 days. Severity ratings ranged from 0 to 3 with lower numbers being less severe and higher numbers being more severe. Data from the day and night severity ratings were averaged for a single daily score. The single daily scores for the week prior to the week 4 study assessment were summed and averaged to produce a mean daily VMS severity for week 4.|Week 4|Intention-to-treat, i.e., all participants with follow-up data were included.||units on a scale||95% Confidence Interval|Mean
693227|NCT01418209|Primary|Frequency of Hot Flashes (Vasomotor Symptom [VMS] Frequency) -- Week 4|Measured by self-report diary twice daily (day and night). The day and night frequencies were summed to produce a single number of hot flashes per day. The single number of hot flashes per day were summed and averaged for one week prior to the week 4 study assessment to produce a mean daily frequency for week 4.|Week 4|Intention-to-treat, i.e., all participants with follow-up data were included.||number of hot flashes per day||95% Confidence Interval|Mean
693228|NCT01418001|Secondary|Pathologic Response|will be assessed by both MRI and by pathologic review after surgery. An estimate of each response rate and the 95% CI will be provided|2 years||||||
693229|NCT01418001|Primary|Overall Objective Response|Overall objective response measured using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.|Every 6 weeks|||participants|||Number
693230|NCT01417936|Secondary|Number of Subjects With Adverse Events (AEs), Serious AEs, AEs Leading to Death and AEs Leading to Discontinuation|An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.|From the first dose of study drug administration up to 4 weeks after the last dose of study drug administration|The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment.||Subjects|||Number
693231|NCT01417936|Secondary|Volume of Distribution (Vz)|Volume of distribution was defined as the theoretical volume in which the total amount of drug needed to be uniformly distributed to produce the desired serum concentration of a drug.|Pre-treatment, 1, 2, 4, 8, 24, and 48 hours post-infusion at Week 0 and Week 3|The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment. ‘n’ signifies subjects who were evaluable at given time points.||milliliter/kilogram||Standard Deviation|Mean
693260|NCT01417377|Secondary|Time to Achieve Hb Level to 11-12 g/dL||Up to 6 months|None of the enrolled participants in the study achieved Hb level between 11 to 12 g/dL during the final 2 months of study, therefore this particular endpoint was not analyzed.|||||
693233|NCT01417936|Secondary|Time to Reach Maximum Serum Concentration (Tmax)||Pre-treatment, 1, 2, 4, 8, 24, and 48 hours post-infusion at Week 0 and Week 3|The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment. ‘n’ signifies subjects who were evaluable at given time points.||hour||Standard Deviation|Mean
693234|NCT01417936|Secondary|Terminal Half Life (T1/2)|The apparent terminal half-life was defined as the time required for the serum concentration of Sym004 to decrease 50% in the final stage of its elimination.|Pre-treatment, 1, 2, 4, 8, 24, and 48 hours post-infusion at Week 0 and Week 3|The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment. ‘n’ signifies subjects who were evaluable at given time points.||hour||Standard Deviation|Mean
693235|NCT01417936|Secondary|Clearance (CL)|Clearance of a drug was a measure of the rate at which a drug was metabolized or eliminated by normal biological processes.|Pre-treatment, 1, 2, 4, 8, 24, and 48 hours post-infusion at Week 0 and Week 3|The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment. ‘n’ signifies subjects who were evaluable at given time points.||milliliter/hour/kilogram||Standard Deviation|Mean
693236|NCT01417936|Secondary|Minimum Serum Concentration (Cmin)||Pre-treatment, 1, 2, 4, 8, 24, and 48 hours post-infusion at Week 0 and Week 3|The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment. ‘n’ signifies subjects who were evaluable at given time points.||microgram/milliliter||Standard Deviation|Mean
693237|NCT01417936|Secondary|Maximum Serum Concentration (Cmax)||Pre-treatment, 1, 2, 4, 8, 24, and 48 hours post-infusion at Week 0 and Week 3|The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment. ‘n’ signifies subjects who were evaluable at given time points.||microgram/milliliter||Standard Deviation|Mean
693238|NCT01417936|Secondary|Area Under the Serum Concentration Curve From Time Zero to Infinity (AUC [0-inf])|The AUC (0-inf) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity.|Pre-treatment, 1, 2, 4, 8, 24, and 48 hours post-infusion at Week 0 and Week 3|The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment. ‘n’ signifies subjects who were evaluable at given time points.||microgram-hour/milliliter||Standard Deviation|Mean
693239|NCT01417936|Secondary|Area Under the Serum Concentration Curve From Time Zero to 168 Hours (AUC [0-168])|The AUC (0-168h) was estimated by determining the total area under the curve of the concentration versus time curve.|Pre-treatment, 1, 2, 4, 8, 24, and 48 hours post-infusion at Week 0 and Week 3|The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment. ‘n’ signifies subjects who were evaluable at given time points.||microgram-hour/milliliter||Standard Deviation|Mean
693240|NCT01417936|Secondary|Number of Subjects With Detectable Biomarkers at Any Visit|The biomarkers human papilloma virus (HPV), mutated epidermal growth factor receptor (EGFRvIII), c-MET and human epidermal growth factor receptor (HER) 2, HER3 were analyzed only in tumor cells while EGFR, phosphorylated epidermal growth factor receptor (pEGFR), and Ki-67 were analyzed both in tumor and skin biopsy cells.|Weeks 0 and 4; and 4 weeks after last dose|"The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment. n signifies subjects evaluable for specified biomarker type."||Subjects|||Number
693241|NCT01417936|Secondary|Overall Survival Time|Overall survival time was defined as the time from first infusion of Sym004 until date of death. Subjects who withdraw the consent or lost to follow-up were censored.|Time from first infusion of Sym004 until death, assessed up to 18 months|The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment.||days||95% Confidence Interval|Median
693242|NCT01417936|Secondary|Time to Progression (TTP)|The TTP was defined as the time from first infusion of Sym004 until disease progression according to RECIST Version 1.1 criteria. Disease progression was defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. The subjects who died without prior assessment of PD were censored for TTP.|Time from first infusion of Sym04 until disease progression, assessed up to 18 months|The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment.||days||95% Confidence Interval|Median
693243|NCT01417936|Secondary|Duration of Overall Response|Duration of overall response was defined as the time from the first time point where measurement criteria are met for CR or PR until first date of recurrence or PD was objectively documented according to RECIST Version 1.1. Duration of overall response was censored at date of last imaging data of measured lesions if no confirmation of recurrence or PD was available.|Time from first infusion of Sym004 until disease progression or death, assessed up to 18 months|Duration of overall response could not be calculated as no subject showed CR or PR.|||||
693244|NCT01417936|Secondary|Objective Tumor Response and Derived Endpoints (Objective Response Rate and Disease Control Rate)|"Best objective tumor response was defined as the occurrence of complete response (CR), partial response (PR), stable disease (SD), or PD according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
Objective response was defined as the occurrence of CR or PR according to RECIST Version 1.1. Disease control was defined as the occurrence of CR, PR or SD according to RECIST Version 1.1.
CR: Disappearance of all lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 mm; PR: At least a 30% decrease in the sum of diameters of all - lesions, taking as reference the baseline sum diameters; SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on trial."|Time from first infusion of Sym004 until disease progression or death, assessed up to 18 months|The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment.||Percentage of subjects||95% Confidence Interval|Number
693261|NCT01417377|Primary|Percentage of Participants Maintaining Hemoglobin (Hb) Levels Between 11-12 Gram Per Deciliter (g/dL) During Final 2 Months of Study||Month 4 up to Month 6|None of the enrolled participants in the study achieved Hb level between 11 to 12 g/dL during the final 2 months of study, therefore this particular endpoint was not analyzed.|||||
703388|NCT00094900|Secondary|Mean Change in Serum Amyloid A||12 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||mg/liter||Standard Error|Mean
693245|NCT01417936|Primary|Progression Free Survival (PFS) Time|The PFS time was defined as the time from first infusion of Sym004 until progressive disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. or death. PD was defined as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on trial. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). The unequivocal progression of existing non-target lesions and the appearance of one or more lesions was also considered progression. Subjects who died without confirmed PD were considered as progressed. Subjects who died or showed PD more than 21 days after last treatment were censored (that is, were considered alive without progression on Day 21 after last treatment). Evaluation was done using Kaplan-Meier estimates.|Time from the first infusion of Sym004 until progressive disease or death, assessed up to 24 weeks|The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment.||days||95% Confidence Interval|Median
693246|NCT01417481|Secondary|Changes in Other Spirometric Variables|To correct for the baseline variability, all measurements were expressed as percentage of baseline (value at week 8 with respect to baseline value [beginning of the glycine or placebo period, respectively]).|8 weeks|||Percentage of baseline||Standard Error|Mean
693247|NCT01417481|Secondary|Changes in FEV1, FEF25, and FEFmax|To correct for the baseline variability, all measurements were expressed as percentage of baseline (value at week 8 with respect to baseline value [beginning of the glycine or placebo period, respectively]).|8 weeks|||Percentage of baseline||Standard Error|Mean
693248|NCT01417481|Secondary|Changes in Pulse Oximetry, FEV1/FVC, and FEF50.|To correct for the baseline variability, all measurements were expressed as percentage of baseline (value at week 8 with respect to baseline value [beginning of the glycine or placebo period, respectively]).|8 weeks|||Percentage of baseline||Standard Error|Mean
693249|NCT01417481|Secondary|Changes in Score for Sputum Production, Dyspnea and Global Symptoms|"To correct for the baseline variability, all measurements were expressed as percentage of baseline (value at week 8 with respect to baseline value [beginning of the glycine or placebo period, respectively]).
In the symptoms questionnaire, each respiratory symptom (Cough severity, Sputum features, Appetite, Dyspnea, and Energy perception) was evaluated in a 5-options Likert scale, ranging from 1 (better) to 5 (worse). The total score was computed by the simple sum of the five symptoms."|8 weeks|||Percentage of baseline||Standard Error|Mean
693250|NCT01417481|Primary|Changes in Sputum Concentration of Inflammatory Biomarkers (G-CSF)|To correct for the baseline variability, all measurements were expressed as percentage of baseline (value at week 8 with respect to baseline value [beginning of the glycine or placebo period, respectively]). Then, percentage change was log-transformed to adjust to a normal distribution.|8 weeks|||log (percent change)||Standard Error|Mean
693251|NCT01417481|Primary|Changes in Sputum Concentration of Inflammatory Biomarkers (IL-6)|To correct for the baseline variability, all measurements were expressed as percentage of baseline (value at week 8 with respect to baseline value [beginning of the glycine or placebo period, respectively]). Then, percentage change was log-transformed to adjust to a normal distribution.|8 weeks|From the 13 patients who initiated the study, some children did not expectorate at some visits. Thus, only a non-paired population of 9 children under glycine and 11 under placebo could be analyzed.||log (percent change)||Standard Error|Mean
693252|NCT01417481|Primary|Changes in Serum Concentration of Inflammatory Biomarkers (TNF-alpha)|To correct for the baseline variability, all measurements were expressed as percentage of baseline (value at week 8 with respect to baseline value [beginning of the glycine or placebo period, respectively]). Then, percentages were log-transformed to adjust to a normal distribution.|8 weeks|From the 13 patients who initiated the study, some parents did not give consent for blood sampling, and some children refused the venous puncture at some visits. Thus, only a non-paired population of 9 children per group could be analyzed.||log (percent change)||Standard Error|Mean
693253|NCT01417481|Primary|Changes in Sputum Concentration of Inflammatory Biomarkers (Other Than IL-6 and G-CSF)|To correct for the baseline variability, all measurements were expressed as percentage of baseline (value at week 8 with respect to baseline value [beginning of the glycine or placebo period, respectively]). Then, percentage change was log-transformed to adjust to a normal distribution.|8 weeks|From the 13 patients who initiated the study, some children at some visits could not give an appropriate sputum sample. Thus, only a non-paired population of 9 (glycine group) and 11 (placebo group) children could be analyzed.||log (percent change)||Standard Error|Mean
693254|NCT01417481|Primary|Changes in Serum Concentration of Inflammatory Biomarkers (Other Than TNF-alpha)|To correct for the baseline variability, all measurements were expressed as percentage of baseline (value at week 8 with respect to baseline value [beginning of the glycine or placebo period, respectively]). Then, percentages were log-transformed to adjust to a normal distribution.|8 weeks|From the 13 patients who initiated the study, some parents did not give consent for blood sampling, and some children refused the venous puncture at some visits. Thus, only a non-paired population of 9 children per group could be analyzed.||log (percent change)||Standard Error|Mean
693255|NCT01417481|Secondary|Changes in Clinical Data Scores (Other Than Sputum Production, Dyspnea and Global Symptoms)|"To correct for the baseline variability, all measurements were expressed as percentage of baseline (value at week 8 with respect to baseline value [beginning of the glycine or placebo period, respectively]).
Each respiratory symptom (Cough severity, Sputum features, Appetite, Dyspnea, and Energy perception) was evaluated in a 5-options Likert scale, ranging from 1 (better) to 5 (worse). The total score was computed by the simple sum of the five symptoms."|8 weeks|||Percentage of baseline||Standard Error|Mean
693256|NCT01417455|Primary|Osteoclast Activity Ex-vivo|Total area resorbed by osteoclasts as percentage of total area analyzed|at baseline and at 6 months|||percentage of resorbed area||Inter-Quartile Range|Median
693257|NCT01417455|Primary|Osteoclast Differentiation Ex-vivo|Osteoclasts will be differentiated from untreated patients and patients under several TNF blockers.|at baseline and at 6 months|||OC/mm2||Inter-Quartile Range|Median
693258|NCT01417377|Secondary|Number of Doses of Mircera Taken as Per the Schedule in Summary of Product Characteristics (SmPC)||Up to 6 months|The number of doses were not collected because the participants never achieved Hb level of 11 to 12 g/dL.|||||
693259|NCT01417377|Secondary|Number of Dose Adjustments Required to Maintain Hb Levels||Up to 6 months|None of the enrolled participants in the study achieved Hb level between 11 to 12 g/dL during the final 2 months of study, therefore this particular endpoint was not analyzed.|||||
693262|NCT01417195|Secondary|Participants With Treatment Emergent Adverse Events (TEAEs), Including Ovarian Hyperstimulation Syndrome (OHSS)|A treatment-emergent AE was any AE occurring after start of investigational medicinal product (IMP) and within the time of residual drug effect, or a pretreatment AE or pre-existing medical condition that worsened in intensity after start of IMP and within the time of residual drug effect. The time of residual drug effect was the estimated period of time after the last dose of the IMP, where the effect of the product was still considered to be present based on pharmacokinetic, pharmacodynamic, or other IMP characteristics.|Day 1 up to Day 20|Safety population||participants|||Number
693263|NCT01417195|Secondary|Summary of Assessor Questionnaire on Day 6|"Participants assigned to the Menopur and Bravelle treatment arm prepared and self-administered her daily dose on Day 6 in the presence of the study coordinator or designee assessor. The assessor then completed a 7 question questionnaire with YES or NO answers to document their assessment of participant understanding of drug administration procedures. Reported data represent the number of participants for whom the assessor answered the question YES.
Gonadotropins are referred to as investigational medicinal product (IMP)."|Day 6|Intent to treat population for the combination treatment arm only||participants|||Number
693264|NCT01417195|Secondary|Summary of Assessor Questionnaire on Day 1|"Participants assigned to the Menopur and Bravelle treatment arm read the Mixing Instructions Guide on how to mix and administer the medications at home. Participants were given enough time to read and understand the instructions and ask any questions. After completing the SCQ, participants prepared and self-administered her assigned first daily dose in the presence of the study coordinator or designee assessor. The assessor then completed a 7 question questionnaire with YES or NO answers to document their assessment of participant understanding of drug administration procedures. Reported data represent the number of participants for whom the assessor answered the question YES.
Gonadotropins are referred to as investigational medicinal product (IMP)."|Day 1|Intent to treat population for the combination treatment arm only||participants|||Number
693265|NCT01417195|Secondary|Summary of the Subject Comprehension Questionnaire (SCQ) on Day 6|Subject comprehension questionnaires were repeated on Day 6 after 5 days of combination therapy by participants assigned to the Menopur and Bravelle treatment arm. The SCQ consists of 7 questions with YES/NO answers to self-gauge participants' understanding of drug administration procedures. Reported data represent the number of participants who answered the question YES. Gonadotropins are referred to as investigational medicinal product (IMP).|Day 6|Intent to treat population for the combination treatment arm only||participants|||Number
693266|NCT01417195|Secondary|Summary of the Subject Comprehension Questionnaire (SCQ) on Day 1|Subject comprehension questionnaires were completed on Day 1 only by participants assigned to the Menopur and Bravelle treatment arm. On Day 1, the participant read the Mixing Instructions Guide on how to mix and administer the medications at home. The participant was given enough time to read and understand the instructions and ask any questions. The participant then completed the SCQ which consists of 7 questions with YES/NO answers, to self-gauge their understanding of drug administration procedures. Reported data represent the number of participants who answered the question YES. Gonadotropins are referred to as investigational medicinal product (IMP).|Day 1|Intent to treat population for the combination treatment arm only||participants|||Number
693267|NCT01417195|Primary|Fertilization Rate|The fertilization rate was defined for each participant and calculated as the number of 2 pronuclei (fertilized) (2PN) oocytes divided by the total number of oocytes retrieved multiplied by 100.|approximately day 13 (16-20 hours post insemination by in vitro fertilization (IVF) insemination or intracytoplasmic sperm injection (ICSI))|Intent to treat population||percentage of oocytes retrieved||Standard Deviation|Mean
693268|NCT01417156|Secondary|Percentage of Patient With First Occurrence of Acute Exacerbations of Idiopathic Pulmonary Fibrosis (IPF) Until Week 234.|The percentage of patient having first acute exacerbation of Idiopathic Pulmonary Fibrosis (IPF) based on investigator reported adverse events until week 234.|Week 234|TS||percentage of participants|||Number
693269|NCT01417156|Secondary|Acute Exacerbations of IPF: Risk (Incidence Rate) of Acute Exacerbations of IPF.|The risk (incidence rate calculated as number of patients with at least 1 exacerbation, divided by the total time at risk ×100) of acute exacerbation of IPF.|First drug administration until end of treatment, up to 5 years|TS||patients per 100 patient-year||95% Confidence Interval|Number
693270|NCT01417156|Secondary|Annual Rate of Decline in Haemoglobin (Hb) Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)|"Adjusted annual rate of decline in Hb corrected DLCO. The means presents actually adjusted rate based on random coefficient regression with fixed effects for gender, age, height & random effect of patient specific intercept & time. Within-patient errors are modelled by Unstructured variance-covariance matrix.Inter-individual variability is modelled by a variance-Components variance−covariance matrix.
mmHg: millimeters of mercury"|Baseline & every 8 weeks after drug administration until end of treatment, up to 5 years|OC-TS||mL/Minute(min)/mmHg per year||Standard Error|Mean
693271|NCT01417156|Secondary|Annual Rate of Decline in Forced Vital Capacity (FVC).|"The adjusted annual rate of decline in Forced Vital Capacity (FVC). The means presents actually the adjusted rate based on a random coefficient regression with fixed effects for gender, age, height and random effect of patient specific intercept and time. Within−patient errors are modelled by an Unstructured variance−covariance matrix. Inter−individual variability is modelled by a Variance−Components variance−covariance matrix.
The result for Annual rate of decline (ROD) in FVC should be interpreted with caution and along with descriptive statistics, because inferences used for this analysis might not be valid as suggested by skewed distribution of the data."|Baseline and every 8 weeks after drug administration until end of treatment, up to 5 years|TS-OC Observed Case (OC): This method was used for the replacement of missing values.||(mililitre (mL)/year)||Standard Error|Least Squares Mean
693272|NCT01417156|Primary|Incidence of Overall Adverse Events|Incidence (Number of patients) of Adverse events (AEs) over the course of treatment period including serious adverse events (SAEs), AEs leading to discontinuation of study medication, and fatal AEs.|First drug administration until end of treatment, up to 5 years|Treated set (TS)||participants|||Number
693273|NCT01417104|Other Pre-specified|Change From Baseline in Resting Diastolic Blood Pressure|Difference between end of treatment and baseline in resting diastolic blood pressure|baseline to end of treatment ( up to 36 weeks)|Intent to treat analysis including only participants who had at least one post-baseline assesment||mm Hg||95% Confidence Interval|Mean
699289|NCT00002540|Secondary|T0 (Baseline) DRE Screening Results|Digital Rectal Examination (DRE) result.|T0 (at study entry)|All males in the Prostate Screening arm who had a DRE screen at T0 were analyzed.||Participants|||Number
693274|NCT01417104|Secondary|Change in the Percentage Wall Volume (PWV) Between Baseline and End of Treatment|Using an approach similar to intravascular atheroma volume calculations, percentage wall volume (PWV) for thoracic region, abdominal region and total aorta for each patient and each exam was generated. and a difference between baseline and end of treatment was calculated.|Baseline and end of treatment ( 17 to 36 weeks)|3 MRI not analyzable, 23 final MRI not obtained due to trial termination||Percentage of the Outer Wall Volume||Standard Deviation|Mean
693275|NCT01417104|Primary|Change in Normalized Total Aortic Wall Volume (TWV) Between the Trial Arms at the End of the Treatment|"All patients underwent imaging using a 3T, MRI system. The MRI sequence method used for wall depiction was a 3D, fat suppressed, dark blood, turbo spin echo sequence with variable flip angles (SPACE). Following co-registration of pre and post treatment MR images, and generation of MPR sections, images were magnified, contrast adjusted and patient/exam identifier information was removed and replaced by pre-assigned code to blind images for measurements.
An experienced observer performed manual measurements of lumen and lumen plus wall areas by delineating the inner border and the outer border of the vessel wall in each cross-section image of the aorta. Using an approach similar to intravascular atheroma volume calculations, normalized total aortic wall volume (TWV) for thoracic region, abdominal region and total aorta for each patient and each exam was generated."|Baseline and end of treatment ( 17 to 36 weeks)|3 MRI data sets were not analyzable ( low quality images), and 23 post-treatment MRI not obtained ( <17 weeks on drug when trial terminated owing to ALTITUDE results)||mm3||Standard Deviation|Mean
693276|NCT01417078|Primary|Pharmacokinetic (PK) Parameter: Area Under The Concentration Curve From Time 0 to 12 Hours (AUC(0-12)) and AUC Time to Last Measurable Plasma Concentration|"Summary of Dose-Adjusted Diazepam and Nordiazepam PK parameter AUC(0-12) and AUC(last).
The mean estimate of AUC(0-12) was adjusted to a 20 mg dose. AUC(last) was used for the calculation of AUC for nordiazepam. AUC(0-12) values could not be estimated for nordiazepam given that nordiazepam concentrations were rising between 6 and 12 hours."|Pre-dose, 10, 15, 30, and 45 mins, and 1, 1.5, 2, 4, 6, 9,and 12 hours|"PK Population: patients who had adequate concentration-time data to permit estimation of noncompartmental PK parameters.
One patient was not included in the analysis of nordiazepam due to receiving clorazepate, which interfered with the analysis of nordiazepam from diazepam administration."||hour*nanogram/milliliter (h*ng/mL)||Standard Deviation|Mean
693277|NCT01417078|Primary|Pharmacokinetic (PK) Parameter: Time to Maximum Plasma Concentration (Tmax)|"Summary of Dose-Adjusted Diazepam and Nordiazepam PK parameter Tmax.
The mean Tmax value was adjusted to a 20 mg dose."|Pre-dose, 10, 15, 30, and 45 mins, and 1, 1.5, 2, 4, 6, 9,and 12 hours|"PK Population: patients who had adequate concentration-time data to permit estimation of noncompartmental PK parameters.
One patient was not included in the analysis of nordiazepam due to receiving clorazepate, which interfered with the analysis of nordiazepam from diazepam administration."||hour (h)||Standard Deviation|Mean
693278|NCT01417078|Secondary|Number of Patients With Treatment Emergent Adverse Events (TEAEs)|"TEAEs refer to adverse events with start dates occurring after dosing. Treatment-Related TEAEs refer to those 'possibly' or 'probably' related to study drug.
Intensity definitions:
Mild: Usually transient, required no special treatment, and did not interfere with the patient’s daily activities.
Moderate: Usually caused a low degree of inconvenience or concern to the patient, and may have interfered with daily activities, but was usually ameliorated by simple therapeutic measures.
Severe: Interrupted a patient’s usual daily activities, and generally required systemic drug therapy or other treatment."|Pre-dose to 48 hours post-dose|Safety Population (dosed with study drug)||participants|||Number
693279|NCT01417078|Primary|Pharmacokinetic (PK) Parameter: Maximum Measure Plasma Concentration (Cmax),|Summary of Dose-Adjusted Diazepam and Nordiazepam PK parameter Cmax. The mean Cmax value was adjusted to a 20 mg dose.|Pre-dose, 10, 15, 30, and 45 mins, and 1, 1.5, 2, 4, 6, 9,and 12 hours|"PK Population: patients who had adequate concentration-time data to permit estimation of noncompartmental PK parameters.
One patient was not included in the analysis of nordiazepam due to receiving clorazepate, which interfered with the analysis of nordiazepam from diazepam administration."||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
693280|NCT01417026|Secondary|"Changes From Baseline to Post-testing (After Max. 12 Days) on the Happy Faces Measure of Social Attention"|"The Happy Faces task requires that participants look at a series of faces of men and women. Faces are presented on the screen one by one and children are asked just to look at the faces. Eye movements are measured with a Tobii x120 tabletop eye-tracker to evaluate participants’ looking patterns towards the eyes versus the mouth region."|Baseline and Post-testing (after max. 12 days)|||change in proportion of looking||Standard Deviation|Mean
693281|NCT01417026|Primary|Change From Baseline to Post-testing (After Max. 12 Days) on the Reading the Mind in the Eyes Test (Child Version)|This is a test of emotion recognition. This test asks children to pick the best word out of four options to describe the mental state of a set of eyes. The test includes 28 photographs of eyes with both affective (e.g., upset) and cognitive (e.g., thoughtful) mental state words as choices.|Baseline and Post-testing (after max. 12 days)|||change in items correct||Standard Deviation|Mean
693282|NCT01417026|Primary|Change From Baseline to Post-testing (After Max. 12 Days) on the Part/Whole Identity Test (LFI Skills Battery)|This test measures the extent to which the participant employed a featural or holistic face recognition strategy. A sample face is presented, followed by a test face composed of either two whole faces or two face parts.|Baseline and Post-testing (after max. 12 days)|||change in percent correct||Standard Deviation|Mean
693283|NCT01416610|Secondary|Beck Depression Inventory (BDI) Score by Visit|The BDI questionnaire items were scored by generating the sum of the responses to all answered items. Each result was categorized into one of four categories: 0-13= no depression or clinically not significant or in remission; 14-19= mild depression; 20-28= moderate depression; or 29-63= severe depression. Mean scores are presented by visit.|at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months|Participants with a viable score at the given time point||units on a scale||Standard Deviation|Mean
693284|NCT01416610|Secondary|Beschwerdeliste (BL) Score by Visit|"The BL questionnaire items were scored by calculating the average response to all answered items. Items can be graded 1=stark (affliction is strong) to 4=gar nicht (not present). The higher the BL score, the less afflictions were present for a participant. Mean scores are presented by visit."|at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months|Participants with a viable score at the given time point||units on a scale||Standard Deviation|Mean
703389|NCT00094900|Secondary|Mean Change in Serum Amyloid A||6 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||mg/liter||Standard Error|Mean
693285|NCT01416610|Secondary|Fatigue Severity Scale (FSS) Score by Visit|The Fatigue Severity Scale (FSS) consists of 9 questions, each answered within a range of 1-7, where lower scores indicate less fatigue in everyday life. The FSS score is the mean of the 9 numbers. Mean scores are presented by visit.|at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months|Participants with a viable score at the given time point||units on a scale||Standard Deviation|Mean
693286|NCT01416610|Secondary|Short Form Health Survey (SF-36) Scores by Visit|The SF-36 questionnaire items were scored and transformed according to the SF-36 Health Survey Manual & Interpretation Guide. Summary scores for SF-36 dimensions of physical functioning, role functioning, bodily pain, general health, vitality, social functioning, and mental health were scored on a scale of 0 (worst) to 100 (best), and health transition was scored on a scale of 0 (worst) to 5 (best). Summary SF-36 scores are reported by category and by visit.|at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months|Participants with a viable score at the given time point||units on a scale||Standard Deviation|Mean
693287|NCT01416610|Secondary|Percentage of Participants With Virological Relapse|Virological relapse is defined as no SVR24 in a participant with undetectable HCV RNA at end of treatment who has at least one post-treatment polymerase chain reaction (PCR) result available, using a LOCF approach. Percentage is based on the number of non-missing observations (total).|by end of follow-up, within 3 years, 6 months|Participants who completed treatment||percentage of participants||95% Confidence Interval|Number
693288|NCT01416610|Secondary|Percentage of Participants With End of Treatment Response|A participant was considered to have end of treatment response if there was undetectable HCV RNA after completing treatment, using a LOCF approach. Percentage is based on the number of non-missing observations (total).|at end of treatment, within 3 years, 6 months|||percentage of participants||95% Confidence Interval|Number
693289|NCT01416610|Secondary|Percentage of Participants With SVR 12|SVR 12 is defined as percentage of participants with undetectable HCV RNA 12 weeks after completing treatment, using a LOCF approach. Percentage is based on the number of non-missing observations (total).|12 weeks after completing treatment, within 3 years, 6 months|||percentage of participants||95% Confidence Interval|Number
693290|NCT01416610|Primary|Percentage of Participants With Sustained Virological Response 24 Weeks After Completing Treatment (SVR24)|SVR24 is defined as percentage of participants with undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) 24 weeks after completing treatment, using a last observation carried forward (LOCF) approach. Percentage is based on the number of non-missing observations (total).|24 weeks after completing treatment, within 3 years, 6 months|||percentage of participants||95% Confidence Interval|Number
693301|NCT01416571|Secondary|Number of Subjects With Any and Related Serious Adverse Events (SAEs)|A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or resulted in a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|From Day 0 to Day 84 and from Day 0 to Day 385|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.||Subjects|||Number
693311|NCT01416571|Secondary|Duration of Solicited General Symptoms After Vaccination.|Assessed solicited general symptoms were fatigue, gastrointestinal, headache, joint pain at other location (joint pain), muscle aches, increased sweating and shivering. Duration was defined as the number of days with any grade of general symptoms.|During the 7-day (Days 0-6) post-vaccination period following each dose|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination, on subjects who experienced the specific symptom.||days||Inter-Quartile Range|Median
693302|NCT01416571|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an unsolicited AE regardless of intensity grade or relationship to vaccination. Grade 3 = event which prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination.|From Day 0 to Day 20 and from Day 0 to Day 84.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.||Subjects|||Number
693303|NCT01416571|Secondary|Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.|Assessed biochemical and haematological parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS), blood urea nitrogen (BUN), creatinine (CREA), eosinophils (EOS), haematocrit (HCRIT), haemoglobin (HBIN), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC), total bilirubin (Total BIL), bilirubin conjugated/direct (BIL con/dir). Per parameter, it was assessed whether subjects had laboratory values unknown, below, within or above the normal ranges. This outcome presents Total BIL, BIL con/dir, CREA and BUN results.|At Day 0 and Day 42|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.||Subjects|||Number
693304|NCT01416571|Secondary|Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.|Assessed biochemical and haematological parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS), blood urea nitrogen (BUN), creatinine (CREA), eosinophils (EOS), haematocrit (HCRIT), haemoglobin (HBIN), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC), total bilirubin (Total BIR), bilirubin conjugated/direct (BIL con/dir). Per parameter, it was assessed whether subjects had laboratory values unknown, below, within or above the normal ranges. This outcome presents WBC, ALT and AST results.|At Day 0 and Day 42|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.||Subjects|||Number
693305|NCT01416571|Secondary|Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.|Assessed biochemical and haematological parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS), blood urea nitrogen (BUN), creatinine (CREA), eosinophils (EOS), haematocrit (HCRIT), haemoglobin (HBIN), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC), total bilirubin (Total BIR), bilirubin conjugated/direct (BIL con/dir). Per parameter, it was assessed whether subjects had laboratory values unknown, below, within or above the normal ranges. This outcome presents NEU, PLA and RBC results.|At Day 0 and Day 42|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.||Subjects|||Number
693306|NCT01416571|Secondary|Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.|Assessed biochemical and haematological parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS), blood urea nitrogen (BUN), creatinine (CREA), eosinophils (EOS), haematocrit (HCRIT), haemoglobin (HBIN), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC), total bilirubin (Total BIR), bilirubin conjugated/direct (BIL con/dir). Per parameter, it was assessed whether subjects had laboratory values unknown, below, within or above the normal ranges. This outcome presents HBIN, LYM and MON results.|At Day 0 and Day 42|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.||Subjects|||Number
693307|NCT01416571|Secondary|Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.|Assessed biochemical and haematological parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS), blood urea nitrogen (BUN), creatinine (CREA), eosinophils (EOS), haematocrit (HCRIT), haemoglobin (HBIN), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC), total bilirubin (Total BIR), bilirubin conjugated/direct (BIL con/dir). Per parameter, it was assessed whether subjects had laboratory values unknown, below, within or above the normal ranges. This outcome presents BAS, EOS and HCRIT results.|At Day 0 and Day 42|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.||Subjects|||Number
693308|NCT01416571|Secondary|Number of Subjects With Potential Immune Mediated Disease (s) (pIMDs).|pIMDs are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune aetiology.|From Day 0 to Day 84 and from Day 0 to Day 385|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.||Subjects|||Number
693309|NCT01416571|Secondary|Number of Subjects With Any, Grade 3 and Related Medically Attended Adverse Events (MAEs).|MAE was defined as any unsolicited symptom that received medical attention such as hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel for any reason. Any = occurrence of any MAEs regardless of intensity grade or relationship to vaccination. Grade 3 = event which prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination.|From Day 0 to Day 385|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.||Subjects|||Number
693310|NCT01416571|Secondary|Number of Subjects With Any, Grade 3 and Related Medically Attended Adverse Events (MAEs).|MAE was defined as any unsolicited symptom that received medical attention such as hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any = occurrence of any MAEs regardless of intensity grade or relationship to vaccination. Grade 3 = event which prevented normal activities Related = event assessed by the investigator as causally related to the study vaccination.|From Day 0 to Day 84|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.||Subjects|||Number
699169|NCT01347840|Secondary|Subject Questionnaires|The subscales and total scores as set out in the scoring algorithms for Food Craving Inventory-II and Questionnaire on Craving for Sweet and Rich Foods will be presented.|16 months|||participants|||Number
693312|NCT01416571|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal, headache, joint pain at other location (joint pain), muscle aches, shivering, sweating and fever. Any = occurrence of any solicited general symptoms regardless of intensity grade or relationship to vaccination. Any fever was defined as axillary temperature ≥ 38 degrees Celsius (°C). Grade 3 = general symptom that prevented normal activities. Grade 3 fever = fever ≥ 39.0°C. Related = general symptom assessed by the investigator as causally related to the vaccination.|During the 7-day follow-up period (Days 0-6) after any vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.||Subjects|||Number
693313|NCT01416571|Secondary|Duration of Solicited Local Symptoms After Vaccination.|Assessed solicited local symptoms were pain, redness and swelling. Duration was defined as the number of days with any grade of local symptoms.|During the 7-day (Days 0-6) post-vaccination period following each dose|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination, on subjects who experienced the specific symptom.||days||Inter-Quartile Range|Median
693314|NCT01416571|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any solicited local symptoms regardless of intensity grade. Grade 3 pain = significant pain at rest; prevented normal activities. Grade 3 Redness/Swelling = Redness/Swelling >100 millimeters (mm).|During the 7-day follow-up period (Days 0-6) after any vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.||Subjects|||Number
693315|NCT01416571|Secondary|Mean Geometric Increase (MGI) for the H5N1 Strain of Influenza Disease.|MGI was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer for the vaccine virus.|At Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for persistence at Day 182, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against the vaccine-homologous H5N1 HA antigen for the blood samples taken at Day 0 and Day 182 were available.||ratio||95% Confidence Interval|Geometric Mean
693316|NCT01416571|Secondary|Number of Seroconverted Subjects Against the H5N1 Strain of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer < 1:10 and a post-vaccination reciprocal HI titer (≥) 1:40 or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a four-fold increase in post-vaccination reciprocal titer against the vaccine virus.|At Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for persistence at Day 182, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against the vaccine-homologous H5N1 HA antigen for the blood samples taken at Day 0 and Day 182 were available.||Subjects|||Number
693317|NCT01416571|Secondary|Number of Seroprotected Subjects Against the H5N1 Strain of Influenza Disease.|A seroprotected subject was defined as a vaccinated subject who had H5N1 reciprocal HI titers ≥ 1:40 against the vaccine-homologous virus.|At Day 0 and Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for persistence at Day 182, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against the vaccine-homologous H5N1 HA antigen for the blood samples taken at Day 0 and Day 182 were available.||Subjects|||Number
693318|NCT01416571|Secondary|Titers for Serum HI Antibodies Against the H5N1 Strain of Influenza Disease.|Titers are presented as geometric mean titers (GMTs).|At Day 0 and Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for persistence at Day 182, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against the vaccine-homologous H5N1 HA antigen for the blood samples taken at Day 0 and Day 182 were available.||titers||95% Confidence Interval|Geometric Mean
693319|NCT01416571|Secondary|Number of Seropositive Subjects Against the H5N1 Strain of Influenza Disease.|A seropositive subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:10.|At Day 0 and Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for persistence at Day 182, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against the vaccine-homologous H5N1 HA antigen for the blood samples taken at Day 0 and Day 182 were available.||Subjects|||Number
693320|NCT01416571|Secondary|Titers for Serum HI Antibodies Against the H5N1 Strain of Influenza Disease.|Titers are presented as geometric mean titers (GMTs).|At Day 0 and Day 42|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against vaccine-homologous H5N1 Hemagglutinin (HA) antigen for the blood samples taken at Day 0, and Day 42 were available.||titers||95% Confidence Interval|Geometric Mean
693321|NCT01416571|Secondary|Number of Seropositive Subjects Against the H5N1 Strain of Influenza Disease.|A seropositive subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:10.|At Day 0 and Day 42|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against vaccine-homologous H5N1 Hemagglutinin (HA) antigen for the blood samples taken at Day 0, and Day 42 were available.||Subjects|||Number
693322|NCT01416571|Primary|Number of Seroprotected Subjects Against the H5N1 Strain of Influenza Disease.|A seroprotected subject was defined as a vaccinated subject who had H5N1 reciprocal HI titers ≥ 1:40 against the vaccine-homologous virus.|At Day 42|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against vaccine-homologous H5N1 Hemagglutinin (HA) antigen for the blood samples taken at Day 0, and Day 42 were available.||Subjects|||Number
693323|NCT01416571|Primary|Mean Geometric Increase (MGI) for the H5N1 Strain of Influenza Disease.|MGI was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer for the vaccine virus.|At Day 42|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against vaccine-homologous H5N1 Hemagglutinin (HA) antigen for the blood samples taken at Day 0, and Day 42 were available.||ratio||95% Confidence Interval|Geometric Mean
693324|NCT01416571|Primary|Number of Seroconverted Subjects Against the H5N1 Strain of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer less than (<) 1:10 and a post-vaccination reciprocal HI titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a four-fold increase in post-vaccination reciprocal titer against the vaccine virus.|At Day 42|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against vaccine-homologous H5N1 Hemagglutinin (HA) antigen for the blood samples taken at Day 0, and Day 42 were available.||Subjects|||Number
693325|NCT01416272|Secondary|Visual Acuity - High Contrast|High contrast visual acuity measured with high ambient illumination (HCHI)|4 visits over 1 year|DUE TO THE CANCELLATION OF THIS PROJECT, NO STATISTICAL OR CLINICALLY MEANINGFUL CONCLUSIONS RELATED TO THE STUDY ENDPOINTS WERE MADE.|||||
693326|NCT01416272|Secondary|Visual Acuity - Low Contrast|Low contrast visual acuity measured with high ambient illumination (LCHI)|4 visits over 1 year|DUE TO THE CANCELLATION OF THIS PROJECT, NO STATISTICAL OR CLINICALLY MEANINGFUL CONCLUSIONS RELATED TO THE STUDY ENDPOINTS WERE MADE.|||||
693327|NCT01416272|Primary|Comfort|Symptoms and complaints measured on an analog scale|4 visits over 1 year|DUE TO THE CANCELLATION OF THIS PROJECT, NO STATISTICAL OR CLINICALLY MEANINGFUL CONCLUSIONS RELATED TO THE STUDY ENDPOINTS WERE MADE.|||||
693328|NCT01416181|Secondary|Part 2: Percentage Change From Baseline (Part 1) in Number of New/Enlarging T2 Lesions|New or enlarging T2 lesions as measured by MRI.|Baseline (Part 1) and Weeks 156 and 204|Summary new/enlarging T2 lesion values are provided in previous Outcome Measure. Due to the nature of self-selected population in an extension trial and sparse data up to Week 204, further tabulations on percentage changes on these endpoints were deemed less meaningful and unnecessary, and the analysis was not done.|||||
693329|NCT01416181|Secondary|Part 2: Summary of New/Enlarging T2 Lesion Counts|New or enlarging T2 lesions as measured by MRI.|Baseline (Part 1) up to Week 204|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment (Part 2); n=participants who had an assessment at Baseline and given time point.||lesions||Standard Deviation|Mean
693330|NCT01416181|Secondary|Part 2: Percentage Change From Baseline (Part 1) in Whole Gray Matter Brain Volume|Whole grey matter brain volume as measured by MRI.|Baseline (Part 1) and Weeks 156 and 204|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment (Part 2); n=participants who had an assessment at Baseline and given time point.||percentage change||Standard Deviation|Mean
693331|NCT01416181|Secondary|Part 2: Percentage Change From Week 24 (Part 1) in Whole Brain Volume|Whole brain volume as measured by MRI.|Week 24 (Part 1) and Weeks 156 and 204|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment (Part 2); n=participants who had an assessment at Baseline and given time point.||percentage change||Standard Deviation|Mean
693332|NCT01416181|Secondary|Part 2: Percentage Change From Baseline (Part 2) in the WPAI-MS Questionnaire|The WPAI questionnaire is a validated instrument to measure impairments in work and activities. The WPAI yields four types of scores: 1. Absenteeism (percentage of work time missed) 2. Presenteesism (percentage of impairment at work/reduced on-the-job effectiveness) 3. Work productivity loss (WPL; percentage of overall work impairment [absenteeism plus presenteeism]) 4. Activity Impairment (AI; percentage of overall activity impairment). WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.|Part 2 Baseline (Week 108) and Weeks 156 and 204|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment (Part 2); n=participants who had an assessment at Baseline and given time point.||percentage change||Standard Deviation|Mean
693333|NCT01416181|Secondary|Part 2: Absolute Change From Baseline (Part 2) in the Work Productivity and Activity Impairment – Multiple Sclerosis (WPAI-MS) Questionnaire|The WPAI questionnaire is a validated instrument to measure impairments in work and activities. The WPAI yields four types of scores: 1. Absenteeism (percentage of work time missed) 2. Presenteesism (percentage of impairment at work/reduced on-the-job effectiveness) 3. Work productivity loss (percentage of overall work impairment [absenteeism plus presenteeism]) 4. Activity Impairment (percentage of overall activity impairment). WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.|Part 2 Baseline (Week 108) and Weeks 156 and 204|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment (Part 2) who had an assessment at Baseline and given time point.||percentage of impairment||Standard Deviation|Mean
693334|NCT01416181|Secondary|Part 2: Percentage Change From Baseline (Part 1) in the SDMT|SDMT is a screening test for cognitive impairment. Participants are given 90 seconds in which to pair specific numbers with given geometric figures using a key. Scores range from 0 to 110 (best).|Baseline (Part 1) and every 4 weeks from Week 108 to Week 204|Actual change from baseline tables are provided in previous Outcome Measure. Due to the nature of self-selected population in an extension trial and sparse data up to Weeks 204 and 252, further tabulations on percentage changes on these endpoints were deemed less meaningful and unnecessary, and the analysis was not done.|||||
693335|NCT01416181|Secondary|Part 2: Absolute Change From Baseline (Part 1) in the Symbol Digit Modalities Test (SDMT)|SDMT is a screening test for cognitive impairment. Participants are given 90 seconds in which to pair specific numbers with given geometric figures using a key. Scores range from 0 to 110 (best).|Baseline (Part 1) and every 4 weeks from Week 108 to Week 204|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment (Part 2). Missing values were imputed using last observation carried forward.||units on a scale||Standard Deviation|Mean
693336|NCT01416181|Secondary|Part 2: Percentage Change From Baseline (Part 1) in the MSIS-29 Physical Score|The 29-item MSIS-29 is a patient-reported outcome measure to assess the impact of MS on day-to-day life during the past 2 weeks from a patient’s perspective; it measures 20 physical items and 9 psychological items. The physical score is generated by summing individual items and then transforming to a scale with a range of 0 to 100, where high scores indicate worse health. A negative number on change from baseline value indicates an improvement in MSIS-29.|Baseline (Part 1) and Weeks 156, 204|Actual change from baseline tables are provided in previous Outcome Measure. Due to the nature of self-selected population in an extension trial and sparse data on Weeks 204 and 252, further tabulations on percentage changes on these endpoints were deemed less meaningful and unnecessary.|||||
693337|NCT01416181|Secondary|Part 2: Absolute Change From Baseline (Part 1) in the MSIS-29 Physical Score|The 29-item MSIS-29 is a patient-reported outcome measure to assess the impact of MS on day-to-day life during the past 2 weeks from a patient’s perspective; it measures 20 physical items and 9 psychological items. The physical score is generated by summing individual items and then transforming to a scale with a range of 0 to 100, where high scores indicate worse health. A negative number on change from baseline value indicates an improvement in MSIS-29.|Baseline (Part 1) and Weeks 156 and 204|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment (Part 2) who had an assessment at Baseline and given time point.||units on a scale||Standard Deviation|Mean
693338|NCT01416181|Secondary|Part 2: Percentage Change From Baseline (Part 1) in the 6MWT|The 6MWT measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes.|Baseline (Part 1) and Weeks 156, 204|Actual change from baseline tables are provided in previous Outcome Measure. Due to the nature of self-selected population in an extension trial and sparse data on Weeks 204 and 252, further tabulations on percentage changes on these endpoints were deemed less meaningful and unnecessary.|||||
693339|NCT01416181|Secondary|Part 2: Absolute Change From Baseline (Part 1) in the 6-Minute Walk Test (6MWT)|The 6MWT measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes.|Baseline (Part 1) and Weeks 156 and 204|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment (Part 2); n=participants who had an assessment at Baseline and given time point.||meters||Standard Deviation|Mean
693340|NCT01416181|Secondary|Part 2: Percentage Change From Baseline (Part 1) in EDSS|The EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. Scoring is based on measures of impairment in eight functional systems on examination by a neurologist. Values are presented for the overall group, as well as the CP (defined in the primary outcome measure description above) and NP subgroups.|Baseline (Part 1) and Weeks 156, 204|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment (Part 2); n=participants who had an assessment at Baseline and given time point.||percentage change||Standard Deviation|Mean
693341|NCT01416181|Secondary|Part 2: Absolute Change From Baseline (Part 1) in EDSS|The EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. Scoring is based on measures of impairment in eight functional systems on examination by a neurologist. Values are presented for the overall group, as well as the CP (defined in the primary outcome measure description above) and NP subgroups.|Baseline (Part 1) and Weeks 156, 204|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment (Part 2); n=participants who had an assessment at Baseline and given time point.||units on a scale||Standard Deviation|Mean
693342|NCT01416181|Secondary|Part 2: Percentage Change From Baseline (Part 1) in 9HPT (Non-Dominant Hand)|The 9HPT is a brief, standardized, quantitative test of upper extremity function. The participant picks up 9 pegs puts them in a block containing nine empty holes, and, once they are in the holes, removes them again as quickly as possible one at a time. The total time to complete the task is recorded. Two consecutive trials with the dominant hand are immediately followed by two consecutive trials with the non-dominant hand. The two trials for each hand are averaged. Values are presented for the overall group, as well as the CP (defined in the primary outcome measure description above) and NP subgroups.|Baseline (Part 1) and Weeks 156, 204|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment (Part 2); n=participants who had an assessment at Baseline and given time point.||percentage change||Standard Deviation|Mean
693343|NCT01416181|Secondary|Part 2: Absolute Change From Baseline (Part 1) in 9HPT (Non-Dominant Hand)|The 9HPT is a brief, standardized, quantitative test of upper extremity function. The participant picks up 9 pegs puts them in a block containing nine empty holes, and, once they are in the holes, removes them again as quickly as possible one at a time. The total time to complete the task is recorded. Two consecutive trials with the dominant hand are immediately followed by two consecutive trials with the non-dominant hand. The two trials for each hand are averaged. Values are presented for the overall group, as well as the CP (defined in the primary outcome measure description above) and NP subgroups.|Baseline (Part 1) and Weeks 156, 204|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment (Part 2); n=participants who had an assessment at Baseline and given time point.||seconds||Standard Deviation|Mean
693344|NCT01416181|Secondary|Part 2: Percentage Change From Baseline (Part 1) in 9HPT (Dominant Hand)|The 9HPT is a brief, standardized, quantitative test of upper extremity function. The participant picks up 9 pegs puts them in a block containing nine empty holes, and, once they are in the holes, removes them again as quickly as possible one at a time. The total time to complete the task is recorded. Two consecutive trials with the dominant hand are immediately followed by two consecutive trials with the non-dominant hand. The two trials for each hand are averaged. Values are presented for the overall group, as well as the CP (defined in the primary outcome measure description above) and NP subgroups.|Baseline (Part 1) and Weeks 156, 204|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment (Part 2); n=participants who had an assessment at Baseline and given time point.||percentage change||Standard Deviation|Mean
693345|NCT01416181|Secondary|Part 2: Absolute Change From Baseline (Part 1) in 9HPT (Dominant Hand)|The 9HPT is a brief, standardized, quantitative test of upper extremity function. The participant picks up 9 pegs puts them in a block containing nine empty holes, and, once they are in the holes, removes them again as quickly as possible one at a time. The total time to complete the task is recorded. Two consecutive trials with the dominant hand are immediately followed by two consecutive trials with the non-dominant hand. The two trials for each hand are averaged. Values are presented for the overall group, as well as the CP (defined in the primary outcome measure description above) and NP subgroups.|Baseline (Part 1) and Weeks 156, 204|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment (Part 2); n=participants who had an assessment at Baseline and given time point.||seconds||Standard Deviation|Mean
693365|NCT01416129|Primary|Balance and Stability|Balance and stability will be assessed for limits of stability and postural stability.|Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.||||||
693346|NCT01416181|Secondary|Part 2: Percentage Change From Baseline (Part 1) in T25FW|The T25FW is a quantitative mobility and leg function performance test based on a timed 25-foot walk. The participant is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The time is calculated from the initiation of the instruction to start and ends when the participant has reached the 25-foot mark. The task is immediately repeated; the score for the T25FW is the average of the two completed trials. Values are presented for the overall group, as well as the CP (defined in the primary outcome measure description above) and NP subgroups.|Baseline (Part 1) and Weeks 156, 204|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment (Part 2); n=participants who had an assessment at Baseline and given time point.||percentage change||Standard Deviation|Mean
693347|NCT01416181|Secondary|Part 2: Absolute Change From Baseline (Part 1) in T25FW|The T25FW is a quantitative mobility and leg function performance test based on a timed 25-foot walk. The participant is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The time is calculated from the initiation of the instruction to start and ends when the participant has reached the 25-foot mark. The task is immediately repeated; the score for the T25FW is the average of the two completed trials. Lower scores on time taken to reach 25 foot mark reflect a better outcome. Values are presented for the overall group, as well as the Confirmed Progressor (CP, defined in the primary outcome measure description above) and Non-Progressor (NP) subgroups.|Baseline (Part 1) and Weeks 156, 204|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment (Part 2); n=participants who had an assessment at Baseline and given time point.||seconds||Standard Deviation|Mean
693348|NCT01416181|Secondary|Part 2: Percentage of Participants With Disability Worsening at 156 Weeks|Percentage of participants with disability worsening at each scheduled efficacy visit in Part 2, defined as one or more of the following: • ≥ 20% worsening from Part 1 baseline in T25FW; • ≥ 20% worsening from Part 1 baseline in 9HPT; • Worsening from Part 1 baseline in EDSS (≥ 1 point increase if Part 1 baseline EDSS ≤ 5.5 or ≥ 0.5 point increase if Part 1 baseline EDSS > 5.5). The EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. The T25FW is a quantitative mobility and leg function performance test where the participant is timed while walking for 25 feet. The 9HPT is a quantitative test of upper extremity function that measures the time it takes to place 9 pegs into 9 holes and then remove the pegs. 95% CIs of percentages are based on normal approximation.|Week 156|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment (Part 2).||percentage of participants||95% Confidence Interval|Number
693349|NCT01416181|Secondary|Part 1: Percentage of Participants Defined as Confirmed Progressors on EDSS Functional System Scores|"The EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. Scoring is based on measures of impairment in eight functional systems on examination by a neurologist. Participants with confirmed progression of disability in EDSS physical functional system scores will be defined as those who met one of the following criteria:
an increase of ≥ 1 point from baseline system score of ≥ 1 or an increase of ≥ 2 points from baseline system score of 0 in at least 2 physical functional systems, or
an increase of ≥ 2 points from baseline system score of ≥ 1 or an increase of ≥ 3 points from baseline system score of 0 in any 1 physical functional system.
A confirmed progressor was defined as a participant who met the criteria for disability progression at any given visit and at the 6-Month Confirmation Visit. The 95% CIs are based on normal approximation."|Up to 96 weeks|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment.||percentage of participants||95% Confidence Interval|Number
693350|NCT01416181|Secondary|Part 1: Percentage Change From Week 24 in Whole Brain Volume at Week 96|Whole brain volume as measured by MRI.|Week 24 and Week 96|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment. Includes those participants with an assessment at Weeks 24 and 96.||percentage change||Standard Deviation|Mean
693351|NCT01416181|Secondary|Part 1: Change From Baseline in the Multiple Sclerosis Impact Scale-29 Physical (MSIS-29 Physical) Score|The 29-item MSIS-29 is a participant-reported outcome measure to assess the impact of MS on day-to-day life during the past 2 weeks from a participant’s perspective; it measures 20 physical items and 9 psychological items. The physical score is generated by summing individual items and then transforming to a scale with a range of 0 to 100, where high scores indicate worse health. A negative number on change from baseline value indicates an improvement in MSIS-29.|Baseline and Week 96|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment. Excludes participants who withdrew prior to 1 year (defined as stopping treatment prior to Week 48) of participation in the study.||units on a scale||Standard Deviation|Mean
693352|NCT01416181|Secondary|Part 1: Change From Baseline in Manual Ability Score Based on the ABILHAND Questionnaire|The ABILHAND Questionnaire measures the participant’s perceived difficulty in performing everyday manual activities in the last 3 months. The participant completes a 56-item questionnaire by estimating their own difficulty or ease in performing each of 56 activities. Items are summed to generate a total score and transformed to a scale with a range of 0 to 100, where high scores indicate greater impact on manual ability. A positive number on change from baseline value indicates an improvement in ABILHAND.|Baseline and Week 96|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment. Excludes participants who withdrew prior to 1 year (defined as stopping treatment prior to Week 48) of participation in the study.||units on a scale||Standard Deviation|Mean
693353|NCT01416181|Secondary|Part 1: Change From Baseline in the 12-Item MS Walking Scale (MSWS-12)|MSWS-12 is a participant self-assessment of the walking limitations due to MS during the past 2 weeks. It contains 12 items that measure the impact of MS on walking. Items are summed to generate a total score and transformed to a scale with a range of 0 to 100, where higher scores indicate greater impact on walking. A negative number on change from BL value indicates an improvement in MSWS-12.|Baseline and Week 96|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment. Excludes participants who withdrew prior to 1 year (defined as stopping treatment prior to Week 48) of participation in the study.||units on a scale||Standard Deviation|Mean
693366|NCT01416129|Primary|Gait|Gait will be assessed in terms of biomechanics and spatiotemporal parameters.|Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.||||||
693354|NCT01416181|Secondary|Part 1: Percentage of Participants With a T25FW Response|T25FW response is defined as any improvement from the best pre-dose T25FW in at least 75% of the scheduled on-treatment visits through Week 96. The T25FW is a quantitative mobility and leg function performance test based on a timed walk over 25 feet. The participant is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The time is calculated from the initiation of the instruction to start and ends when the participant has reached the 25-foot mark. The task is immediately administered again by having the patient walk back the same distance. The score for the T25FW is the average of the 2 completed trials. The 95% CI of the percentage is based on normal approximation.|Up to 96 weeks|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment. Excludes participants who withdrew prior to 1 year (defined as stopping treatment prior to Week 48) of participation in the study.||percentage of participants||95% Confidence Interval|Number
693355|NCT01416181|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: any untoward medical occurrence that did not necessarily have a causal relationship with this treatment. SAE: any untoward medical occurrence that at any dose: resulted in death; in the view of the Investigator, placed the participant at immediate risk of death (a life-threatening event); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect. An SAE may have also been any other medically important event in the opinion of the Investigator.|218 weeks|Safety population: all participants who were randomized in Part 1 and received at least 1 infusion of study treatment in Part 2.||participants|||Number
693356|NCT01416181|Primary|Part 1: Percentage of Participants With Confirmed Progression of Disability in One or More of the Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW), or 9-Hole Peg Test (9HPT)|"Confirmed disability progression, defined as ≥1 of the following criteria (confirmed at a second visit ≥6 months later and at Week 96):
Confirmed progression in EDSS (EDSS score increased from baseline [BL] by ≥1 point if BL EDSS ≤5.5 or by ≥0.5 points if BL EDSS ≥6);
Confirmed progression in T25FW (T25FW increased by ≥20% of the BL walk);
Confirmed progression in 9HPT (9HPT increased by ≥20% of the time taken at BL on either hand and confirmed on the same hand).
The EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. The T25FW is a quantitative mobility and leg function performance test where the participant is timed while walking for 25 feet. The 9HPT is a quantitative test of upper extremity function that measures the time it takes to place 9 pegs into 9 holes and then remove the pegs. The 95% confidence interval (CI) of the percentage is based on normal approximation."|Up to 96 weeks (2 years)|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment.||percentage of participants||95% Confidence Interval|Number
693357|NCT01416155|Secondary|Mean Change From Baseline in the Assessment of Expanded Disability Status Scale (EDSS) up to Week 192|The EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. Scoring is based on measures of impairment in eight functional systems on examination by a neurologist.|Day 1 up to Week 192|n=number of participants with an assessment at given timepoint.||units on a scale||Standard Deviation|Mean
693358|NCT01416155|Secondary|Adjusted Annualized Relapse Rate|Clinical relapses are defined as new or recurrent neurologic symptoms, not associated with fever or infection, lasting for at least 24 hours, and accompanied by new objective neurological findings upon examination by the neurologist. The annualized relapse rate is calculated overall as the total number of relapses experienced in the study divided by the number of days followed in the study, and the ratio multiplied by 365. Obtained from a Poisson regression model, adjusted for the baseline relapse rate from study 101MS203 (NCT01440101).|Day 1 up to approximately 50 months|||relapses per subject-years|Participants|95% Confidence Interval|Number
693359|NCT01416155|Primary|Number of Participants With Serum Antibodies to Natalizumab|Negative is defined as negative for antibodies at all post-baseline results. Transient positivity is defined as only 1 positive result. Persistent positivity is defined as 2 positive results separated by at least 6 to 12 weeks.|Day 1 up to approximately 50 months|Immunogenicity population: all participants who had received at least 1 infusion of BG00002, were negative for BG00002 antibodies at baseline and had at least 1 nonmissing post-baseline assessment of antibody status.||participants|||Number
693360|NCT01416155|Primary|Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations Due to AEs|An AE was any untoward medical occurrence that did not necessarily have a causal relationship with this treatment. An SAE was any untoward medical occurrence that at any dose: resulted in death; in the view of the Investigators, placed the subject at immediate risk of death (a life-threatening event); however, this did not include an event that, had it occurred in a more severe form, might have caused death; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigators, could have jeopardized the subject or may have required intervention to prevent one of the other outcomes listed in the definition above.|Day 1 through First Follow-Up (12 Weeks After Last Infusion) +/- 7 days. Approximately 62 months|Safety population: all participants who received at least 1 dose of study treatment.||participants|||Number
693361|NCT01416142|Secondary|Preference for Test Lens|Proportion of participants preferring the Test lens over their spectacles. Participants changed from Spectacles to PureVision Lenses or PureVision Lenses to spectacles during movie intermission.|During the movie (Visit 2)|All eligible, dispensed subjects||participants|||Number
693362|NCT01416142|Primary|Visual Acuity|Visual acuity(VA) measured at the screening visit (all eligible participants) while wearing spectacles and the VA measured at the end of study (Visit 3) 1-Week wearing PureVision2 HD lenses. VA wearing spectacles vs. VA wearing PureVision2 HD Lenses, lower the number the better the VA.|Screening visit (Visit 1) and one week follow-up(Visit 3)|Mean scores are based on the number of eyes with nonmissing logMAR VAs. All eligible, dispensed eyes while wearing spectacles vs. wearing PureVision2 lenses.||logMAR|Participants|Standard Deviation|Mean
693363|NCT01416129|Primary|Socket Pressure|Pressure sensors are placed on the skin and measured.|10 minutes after fitting with both sockets|||mm Hg||Standard Deviation|Mean
693364|NCT01416129|Primary|Quality of Life|Validated surveys will be used to solicit participants' subjective experience and feedback.|Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.||||||
693367|NCT01416025|Primary|Number of Participants With Treatment Failure|"The primary endpoint of the study will be a binary outcome, called Failure, defined as one of the following: measured at 42 days from initiation of drug administration:
Progression of underlying infection (clinical failure)
Death
Development of a voriconazole-associated SAE: LFTs, Rash, Visual disturbance, Neurologic abnormality (e.g: hallucinations)"|42 days|||participants|||Number
693368|NCT01415986|Secondary|Changes in the Quality of Life (QoL)|The change in the overall score of the University of Washington quality of life questionnaire (UW-QOL). Each of the domain-specific items is scored from 0 (worst quality of life (QOL) to 100 (Best QOL). The composite score is created by averaging the scores.|Within 1 month of enrollment or as scheduled at screening and at 3 and 5 months after treatment.|No data was collected because the participant was lost to follow up.|||||
693369|NCT01415986|Primary|Local Tumor Response to Interstitial Photodynamic Therapy (I-PDT) With Temoporfin|Longitudinal changes in tumor size (cm) and standardized uptake value (SUV) measured with Positron Emission Tomography - Computed Tomography (PET- CT).|Within 1 month of enrollment or as scheduled at screening and at 3 and 5 months after treatment|No data was collected because the participant was lost to follow up.|||||
693370|NCT01415960|Secondary|Determination of Leuprolide Tmax|Leuprolide Pharmacokinetic Parameters (PK Population).|84 days|||day||Standard Deviation|Mean
693371|NCT01415960|Secondary|Safety Endpoints|"The WHO/ECOG, bone pain, urinary pain and urinary symptoms data reported are the most frequent percentage at the assessment time.
The WHO/ECOG performance status was summarized using the 0 to 4 WHO/ECOG performance status scale. (0= fully active, able to carry on all pre-disease performances without restriction).
Bone pain, urinary pain and urinary symptoms were determined using a 10-point scale (1= no pain/symptoms, 10= worst pain/symptom imaginable)."|168 Days|Safety endpoints adverse events (AEs), local tolerability, vital signs, performance status, bone pain, urinary pain, and urinary symptoms, occurrence of hot flushes and clinical laboratory and electrocardiogram (ECG) results.||percentage of participants|||Number
693372|NCT01415960|Secondary|Determination of Leuprolide Cmax|Leuprolide Pharmacokinetic Parameters (PK Population).|Cmax1: 0, 1 and 4 hours post-dose on Day 0 and once on Days 2, 14, 28, 56; Cmax2: 0, 1 and 4 hours post-dose on Day 84 and once on Days 86, 112 and 168.|||ng/mL||Standard Deviation|Mean
693373|NCT01415960|Secondary|Prostate-specific Antigen (PSA) Concentrations|For purposes of calculating summary statistics, any concentration values Below Limit Quantification (BLQ) were to be assigned ½ the Low Limit Quantification (LLOQ) (LLOQ=0.36). If the calculated mean, median or minimum value at a time point was less than LLOQ, “BLQ” is presented. In addition, since a high proportion of BLQ values may affect the Standard Deviation (SD); if more than 50% of values were imputed, then no mean or median was calculated for that time point.|168 days|||ng/mL||Standard Deviation|Mean
693374|NCT01415960|Secondary|Follicle-stimulating Hormone (FSH)|For purposes of calculating summary statistics, any concentration values Below Limit of Quantification (BLQ) were to be assigned ½ the Low Limit of Quantification (LLOQ) (LLOQ=3.66). If the calculated mean, median or minimum value at a time point was less than LLOQ, “BLQ” is presented. In addition, since a high proportion of BLQ values may affect the Standard Deviation (SD); if more than 50% of values were imputed, then no mean or median was to be calculated for that time point.|168 days|||mIU/mL||Standard Deviation|Mean
693375|NCT01415960|Secondary|Determination of Serum Luteinizing Hormone (LH)|For purposes of calculating summary statistics, any concentration values Below Limit of Quantification (BLQ) were to be assigned ½ the Low Limit of Quantification (LLOQ) (LLOQ=2.00). If the calculated mean, median or minimum value at a time point was less than LLOQ, “BLQ” is presented. In addition, since a high proportion of BLQ values may affect the Standard Deviation (SD); if more than 50% of values were imputed, then no mean or median was calculated for that time point.|168 days|||mIU/mL||Standard Deviation|Mean
693376|NCT01415960|Primary|Percentage of Participants Achieving Chemical Castration (Defined as Testosterone Levels ≤ 0.5 ng/mL) at Days 28, 84, and 168.|The primary endpoint was testosterone ≤ 0.5 ng/mL assessed on Days 28, 84, and 168. Thereby, maintenance of castration was to be demonstrated through Day 168 with no missing data at these key time points, unless the missing data were due to an event unrelated to the study drug (ITT patients).|168 days|||percentage of participants||95% Confidence Interval|Number
693377|NCT01415921|Primary|Post Exercise Heart Rate Recovery|Change in heart rate from peak exercise to 1 minute post-exercise (beats per minute)|12 weeks|Heart rate recovery is also measured as beats/min (peak HR at end of exercise – HR 1 min post exercise = HRR).||beats per minute||Standard Deviation|Mean
693378|NCT01415921|Primary|Baseline Heart Rate Recovery|Change in peak HR at end of exercise to 1 minute post-exercise (beats per minute)|Baseline|Heart rate recovery is also measured as beats/min (peak HR at end of exercise – HR 1 min post exercise = HRR).||beats per minute||Standard Deviation|Mean
693379|NCT01415908|Secondary|Hospital Stay||During the time of hospital stay|||days||Standard Deviation|Mean
693380|NCT01415908|Secondary|Blood Loss||During the operation, an average of 200 minutes for investigational group and 281.5 minutes for control group|||mls||Standard Deviation|Mean
693381|NCT01415908|Secondary|Operative Time||Operative time was recorded from skin incision to wound closure|||minutes||Standard Deviation|Mean
693382|NCT01415908|Secondary|Percent of Subjects Who Had Additional Surgical Procedures/Interventions||24 months|||percentage of participants|||Number
693383|NCT01415908|Secondary|Success Rate of General Health Status|The Medical Outcomes Study 36-Item Short Form (SF-36) health survey was used to assess general health status. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The scores for PCS and MCS are between 0 and 100, with higher scores denoting better quality of life. To be classified as a success, the following criteria must be met for SF-36 PCS and MCS, respectively: post-operative score - pre-operative score >= 0. The results are reported as percent of subjects who have SF-36 PCS success, SF-36 MCS success, and overall SF-36 success.|24 months|||percentage of participants|||Number
693399|NCT01415518|Secondary|Change in COPD Symptoms - Breathing|Change in breathing symptom score (from 0 (none) to 4 (severe)) from run-in period|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements in the whole treatment period (12 weeks)|||Score from 0 to 4||95% Confidence Interval|Least Squares Mean
693523|NCT01413542|Secondary|Assess Effect of ACE and/or DPP4 Inhibition on Heart Rate Response to Substance P (SP)||Heart rate was measured every 5 minutes throughout the study day (and thus during each dose of peptide infusion)|||beats per minute||Standard Error|Mean
693384|NCT01415908|Secondary|Success Rate of Leg Pain|Numerical rating scales were used to evaluate leg pain intensity and frequency. Subjects rated their leg pain intensity on a scale from 0-10, with a score of 0 representing “no pain” and a score of 10 representing “pain as bad as it could be.” Similarly, subjects recorded their leg pain frequency on a scale from 0-10, with a score of 0 being “pain none of the time” and a score of 10 being “pain all of the time.” The total leg pain score were the sum of pain intensity and frequency scores. Success rate of leg pain is reported as percent of subjects whose leg pain improvement met: pre-operative score - post-operative score > 0.|24 months|||percentage of participants|||Number
693385|NCT01415908|Secondary|Success Rate of Back Pain|Numerical rating scales were used to evaluate back pain intensity and frequency. Subjects rated their back pain intensity on a scale from 0-10, with a score of 0 representing “no pain” and a score of 10 representing “pain as bad as it could be.” Similarly, subjects recorded their back pain frequency on a scale from 0-10, with a score of 0 being “pain none of the time” and a score of 10 being “pain all of the time.” The total back pain score were the sum of pain intensity and frequency scores. Success rate of back pain is reported as percent of subjects whose back pain improvement met: pre-operative score - post-operative score > 0.|24 months|||percentage of participants|||Number
693386|NCT01415908|Secondary|Success Rate of Neurological Status|Neurological status was assessed in six sections: motor, sensory, reflexes, straight leg raising, bowel function, and bladder function. Each of the sections had a number of elements. Success rate of neurological status is reported as percent of subjects whose neurological status was maintained or improved in three key neurological assessments—motor, sensory, and deep tendon reflexes.|24 months|||percentage of participants|||Number
693387|NCT01415908|Secondary|Success Rate of Oswestry Disability Index|ODI Questionnaire was used to assess patient back function. The ODI score ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability). Success rate of Oswestry Disability Index (ODI) is reported as percent of subjects whose ODI score met: pre-operative score - post-operative score ≥ 15.|24 months|||percentage of participants|||Number
693388|NCT01415908|Secondary|Rate of Fusion Success|"Rate of fusion success is reported as percent of subjects having fusion success. The fusion success was defined radiologically as:
evidence of bridging bone;
no evidence of motion;
no evidence of radiolucency at greater than 50% of the superior or inferior PEEK spacer-vertebra interface."|24 months|Eight investigational and 3 control subjects were evaluated for fusion success at 24 months.||percentage of participants|||Number
693389|NCT01415908|Primary|Rate of Overall Success|"Rate of overall success is reported as percent of subjects who met all of the following criteria:
fusion at all treated levels (e.g., one level for a one level fusion and two levels for a two level fusion);
pain/disability (Oswestry Disability Index) success;
neurological status success;
no serious adverse event classified as implant associated or implant/surgical procedure associated;
no additional surgical procedure classified as a failure."|24 months|||percentage of participants|||Number
693390|NCT01415583|Primary|Number of Participants With Post-tonsillectomy Bleeding||2 weeks after surgery|||participants||97.5% Confidence Interval|Number
693391|NCT01415531|Secondary|Trough Seated Systolic Blood Pressure (SBP)|Change from baseline in mean seated trough cuff Systolic Blood Pressure (SBP) at Week 8 as measured by an Omron device. The secondary efficacy analysis was based on the Intent to Treat (ITT) population using a Last Observation Carried Forward (LOCF) approach.|Change from Baseline to Week 8|641 patients were randomized to receive double-blind treatment. The Safety population consisted of 641 patients who received at least 1 dose of double-blind treatment. The Intent to Treat population (ITT) consisted of 634 patients who had at least 1 postbaseline seated diastolic blood pressure (DBP) assessment||mm Hg||Standard Deviation|Mean
693392|NCT01415531|Primary|Trough Seated Diastolic Blood Pressure (DBP)|Change from baseline in mean seated trough cuff Diastolic Blood Pressure (DBP) at Week 8 as measured by an Omron device. The primary efficacy analysis was based on the Intent to Treat (ITT) population using a Last Observation Carried Forward (LOCF) approach.|Change from Baseline to Week 8|641 patients were randomized to receive double-blind treatment. The Safety population consisted of 641 patients who received at least 1 dose of double-blind treatment. The Intent to Treat population (ITT) consisted of 634 patients who had at least 1 postbaseline seated diastolic blood pressure (DBP) assessment||mmHG||Standard Deviation|Mean
693393|NCT01415518|Secondary|Use of Reliever Medication During Night in the Whole Treatment Period|Change in the number of inhalations of reliever medication during day from run-in to the whole treatment period|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during night in the whole treatment period (12 weeks)|||times/day||95% Confidence Interval|Least Squares Mean
693394|NCT01415518|Secondary|Use of Reliever Medication During Night in the First Week on Treatment|change in the number of inhalations of reliever medication during day from run-in to the first week on treatment|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during night in the first week on treatment|||times/day||95% Confidence Interval|Least Squares Mean
693395|NCT01415518|Secondary|Use of Reliever Medication During Night in the Last Week on Treatment|Change in the number of inhalations of reliever medication during day from run-in to the whole treatment period|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during night in the last week on treatment|||times/day||95% Confidence Interval|Least Squares Mean
693396|NCT01415518|Secondary|COPD Exacerbations|Severe exacerbations requiring systemic steroids (oral ≥3 days or parenteral) or hospitalisation or emergency room treatment due to worsening of COPD symptoms|Whole treatment period (12 weeks)|||exacerbations/12 weeks||95% Confidence Interval|Least Squares Mean
693397|NCT01415518|Secondary|COPD Symptoms Sputum|Change in sputum symptom score (from 0 (none) to 4 (severe)) from run-in period|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements in the whole treatment period (12 weeks)|||Score from 0 to 4||95% Confidence Interval|Least Squares Mean
693398|NCT01415518|Secondary|COPD Symptoms - Cough|Change in cough symptom score (from 0 (none) to 4 (almost constant)) from run-in period|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements in the whole treatment period (12 weeks)|||Score from 0 to 4||95% Confidence Interval|Least Squares Mean
699170|NCT01347840|Secondary|Adiponectin and Lectin|These laboratory values will be collected at Visit 3, Visit 5, Visit 6, and Visit 10.|16 months|||units on a scale|||Number
693400|NCT01415518|Secondary|Use of Reliever Medication During Day in the Whole Treatment Period|Change in the number of inhalations of reliever medication during day from run-in to the whole treatment period|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during day in the whole treatment period (12 weeks)|||times/day||95% Confidence Interval|Least Squares Mean
693401|NCT01415518|Secondary|Use of Reliever Medication During Day in the First Week on Treatment|Change in the number of inhalations of reliever medication during day from run-in to the first week on treatment|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during day in the first week on treatment|||times/day||95% Confidence Interval|Least Squares Mean
693402|NCT01415518|Secondary|Use of Reliever Medication During Day in the Last Week on Treatment|Change in the number of inhalations of reliever medication during day from run-in to the last week on treatment|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during day in the last week on treatment|||times/day||95% Confidence Interval|Least Squares Mean
693403|NCT01415518|Secondary|Post-dose PEF in Whole Treatment Period|Change in post-dose morning PEF at 5 minutes from run-period to whole treatment period|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured at 5 minutes after inhalation of study drug in whole treatment period (12 weeks)|||L/min||95% Confidence Interval|Least Squares Mean
693404|NCT01415518|Secondary|Post-dose PEF in First Week of Treatment|Change in post-dose morning PEF at 5 minutes from run-in period to first week of treatment|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurments measured at 5 minutes after inhalation of study drug in the first week of treatment|||L/min||95% Confidence Interval|Least Squares Mean
693405|NCT01415518|Secondary|Post-dose PEF in Last Week of Treatment|Change in post-dose morning PEF at 5 minutes from run-period to last week of treatment|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured at 5 minutes after inhalation of study drug in the last week of treatment|||L/min||95% Confidence Interval|Least Squares Mean
693406|NCT01415518|Secondary|Pre-dose PEF in Whole Treatment Period|Change in pre-dose morning PEF from run-in period to whole treatment period|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured before inhalation of study drug in whole treatment period (12 weeks)|||L/min||95% Confidence Interval|Least Squares Mean
693407|NCT01415518|Secondary|Pre-dose PEF in First Week of Treatment|Change in pre-dose morning PEF from run-in period to first week of treatment|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurments measured before inhalation of study drug in the first week of treatment|||L/min||95% Confidence Interval|Least Squares Mean
693408|NCT01415518|Secondary|Pre-dose PEF in Last Week of Treatment|Change in pre-dose morning PEF (Peak Expiratory Flow) from run-in period to last week of treatment|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured before inhalation of study drug in the last week of treatment|||L/min||95% Confidence Interval|Least Squares Mean
693409|NCT01415518|Secondary|Post-dose IC at 60 Minutes|Ratio of post-dose IC at 60 minutes to baseline|Baseline (meaured before inhalation of study drug at week 0) and mean in treatment period (measured at 1 hour after inhalation of study drug at weeks 0, 1, 6, 12)|||Ratio||95% Confidence Interval|Geometric Mean
693410|NCT01415518|Secondary|Pre-dose IC|Ratio of pre-dose IC (Inspiratory Capacity) to baseline|Baseline (meaured before inhalation of study drug at week 0) and mean in treatment period (measured at 1 hour after inhalation of study drug at weeks 0, 1, 6, 12)|||Ratio||95% Confidence Interval|Geometric Mean
693411|NCT01415518|Secondary|Post-dose FVC at 60 Minutes|Ratio of post-dose FVC at 60 minutes to baseline|Baseline (meaured before inhalation of study drug at week 0) and mean in treatment period (measured at 1 hour after inhalation of study drug at weeks 0, 1, 6, 12)|||Ratio||95% Confidence Interval|Geometric Mean
693412|NCT01415518|Secondary|Post-dose FVC at 5 Minutes|Ratio of post-dose FVC at 5 minutes to baseline|Baseline (meaured before inhalation of study drug at week 0) and mean in treatment period (measured at 5 minutes after inhalation of study drug at weeks 0, 1, 6, 12)|||Ratio||95% Confidence Interval|Geometric Mean
693413|NCT01415518|Secondary|Pre-dose FVC|Ratio of pre-dose FVC (Forced Vital Capacity) to baseline|Baseline (meaured before inhalation of study drug at week 0) and mean in treatment period (measured at 1 hour after inhalation of study drug at weeks 0, 1, 6, 12)|||Ratio||95% Confidence Interval|Geometric Mean
693414|NCT01415518|Secondary|Post-dose FEV1 at 60 Minutes|Ratio of post-dose FEV1 at 60 minutes to baseline value|Baseline (meaured before inhalation of study drug at week 0) and mean in treatment period (measured at 1 hour after inhalation of study drug at weeks 0, 1, 6, 12)|FAS||Ratio||95% Confidence Interval|Geometric Mean
693415|NCT01415518|Secondary|Post-dose FEV1 at 5 Minutes|Ratio of post-dose FEV1 at 5 minutes to baseline value|Baseline (-2 weeks) and mean in treatment period (1, 6, 12 weeks) measured at 5 minutes after inhalation of study drug|FAS||Ratio||95% Confidence Interval|Geometric Mean
693416|NCT01415518|Primary|Pre-dose FEV1|Ratio of pre-dose FEV1 (Forced Expiratory Volume in 1 second) in treatment period to baseline value|Baseline (week 0) and mean in treatment period (weeks 1, 6, 12) measured before inhalation of study drug|FAS||Ratio||95% Confidence Interval|Geometric Mean
693417|NCT01415453|Primary|Phosphene Perception in Response to Ultrasound Pulse.|The investigators will test the hypothesis that compression of retinal nerves by ultrasound force will cause perception of light (phosphenes) in blind subjects lacking functioning photoreceptors (retinitis pigmentosa). With each of two 5 msec ARFI exposures, if the subject either perceived the spark of light (phosphene), then it was documented as a positive response; if they did not, it was marked as a negative response.|Subjects will undergo a single examination of approximately 15 minute duration during which they will report perception of phosphenes during ultrasound exposure.|Only one subject was examined.||participants|||Number
693418|NCT01415427|Secondary|Change From Baseline in Urine Keratan Sulfate - MPP|Efficacy was assessed by changes from baseline in urine keratan sulfate (normalized to urine creatinine.)|Baseline to week 168|MPP- modified per-protocol population, define as the ITT(intent to treat) after removing patients who had orthosurgery in first 120 weeks or <96 doses in first 120 weeks||ug/mg||Standard Deviation|Mean
693419|NCT01415427|Secondary|Change From Baseline in Urine Keratan Sulfate - ITT|Efficacy was assessed by changes from baseline in urine keratan sulfate (normalized to urine creatinine.)|Baseline to week 168|ITT-intent-to-treat population, defined as all patients enrolled in the study who received patient IDs regardless of whether they received study drug or not||ug/mg||Standard Deviation|Mean
693420|NCT01415427|Secondary|Change From Baseline in 3-minute Stair Climb Test - MPP|Efficacy was assessed by changes from baseline in 3-minute stair climb test.|Baseline to week 168|MPP- modified per-protocol population, define as the ITT(intent to treat) after removing patients who had orthosurgery in first 120 weeks or <96 doses in first 120 weeks||stairs/min||Standard Deviation|Mean
693421|NCT01415427|Secondary|Change From Baseline in 3-minute Stair Climb Test - ITT|Efficacy was assessed by changes from baseline in 3-minute stair climb test.|Baseline to week 168|ITT-intent-to-treat population, defined as all patients enrolled in the study who received patient IDs regardless of whether they received study drug or not||stairs/min||Standard Deviation|Mean
693422|NCT01415427|Primary|Change From Baseline in 6-minute Walk (6MW) Test - MPP|Efficacy was assessed by changes from baseline in 6-minute walk test|Baseline to week 168|MPP- modified per-protocol population, define as the ITT(intent to treat) after removing patients who had orthosurgery in first 120 weeks or <96 doses in first 120 weeks.||meters||Standard Deviation|Mean
693423|NCT01415427|Primary|Change From Baseline in 6-minute Walk (6MW) Test - ITT|Efficacy was assessed by changes from baseline in 6-minute walk test|Baseline to week 168|ITT-intent-to-treat population, defined as all patients enrolled in the study who received patient IDs regardless of whether they received study drug or not.||meters||Standard Deviation|Mean
693424|NCT01415401|Secondary|Percentage of Subjects Who Reach Target IOP (≤ 18 mmHg)|IOP (fluid pressure inside the eye) was assessed by Goldmann applanation tonometry and measured in mmHg. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.|Week 8|This analysis population includes all subjects who received study medication, completed all study visits, and satisfied inclusion/exclusion criteria. In addition, no imputation methods were employed; therefore only efficacy measurements available at each visit and time point were analyzed.||percentage of participants|||Number
693425|NCT01415401|Primary|Change in IOP at the Final Visit From Prior Brimonidine 0.2%/Timolol 0.5% Fixed Combination (COMBIGAN®) Therapy (i.e. From Baseline)|IOP (fluid pressure inside the eye) was assessed by Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.|Baseline, Week 8|This analysis population includes all subjects who received study medication and had at least one on-therapy study visit. Last observation carried forward (LOCF) was used.||mmHg||Standard Deviation|Mean
693426|NCT01415349|Primary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) for SSP-002358|Area under the plasma concentration versus time curve from time 0 to infinity. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Assessed over 48 hours post-dose|Pharmacokinetic Analysis Set defined as all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Subjects who vomited or experienced significant diarrhea between dosing and 10 hours post-dose were excluded from the pharmacokinetic descriptive statistics and statistical analysis.||ng*h/ml||Standard Deviation|Mean
693427|NCT01415349|Primary|Maximum Plasma Concentration (Cmax) for SSP-002358|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Assessed over 48 hours post-dose|Pharmacokinetic Analysis Set defined as all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Subjects who vomited or experienced significant diarrhea between dosing and 10 hours post-dose were excluded from the pharmacokinetic descriptive statistics and statistical analysis.||ng/ml||Standard Deviation|Mean
693430|NCT01414855|Secondary|Pharmacodynamics: Peripheral Blood CD19-positive B-cell Count||Up to approximately 24 months||||||
693431|NCT01414855|Secondary|Pharmacokinetics: Area Under the Concentration-Time Curve 7 Day (AUC7day)|Blood was collected for PK parameters. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in in day times micrograms per milliliter (day*μg/mL).|Cycle 1 Day 1 pre and post dose, Days 3,5, Day 8 pre and post-dose, Day 15 pre-dose. Cycle 8 Day 1 pre and post-dose, Days 5,8,12|PK-Evaluable included all participants with viable PK data for analysis.||day*μg/mL||Standard Deviation|Mean
693432|NCT01414855|Secondary|Pharmacokinetics: Volume of Distribution (V) for Obinutuzumab|V is the apparent volume in which a drug is distributed in the body. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in milliliters (mL).|Cycle 1 Day 1 pre and post dose, Days 3,5, Day 8 pre and post-dose, Day 15 pre-dose. Cycle 8 Day 1 pre and post-dose, Days 5,8,12|PK-Evaluable included all participants with viable PK data for analysis.||mL||Standard Deviation|Mean
693433|NCT01414855|Secondary|Pharmacokinetics: Clearance (Cl) for Obinutuzumab|Cl is the volume of serum cleared of the drug per unit of time. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in milliliters/day (mL/day).|Cycle 1 Day 1 pre and post dose, Days 3,5, Day 8 pre and post-dose, Day 15 pre-dose. Cycle 8 Day 1 pre and post-dose, Days 5,8,12|PK-Evaluable included all participants with viable PK data for analysis.||mL/day||Standard Deviation|Mean
703390|NCT00094900|Secondary|Mean Change in Serum Amyloid A||3 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||mg/liter||Standard Error|Mean
693434|NCT01414855|Secondary|Pharmacokinetics: Terminal Half-Life (t1/2) for Obinutuzumab|T1/2 is the time required for the concentration of the drug to reach half of its original value. Blood was collected for PK Parameters. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in days|Cycle 1 Day 1 pre and post dose, Days 3,5, Day 8 pre and post-dose, Day 15 pre-dose. Cycle 8 Day 1 pre and post-dose, Days 5,8,12|PK-Evaluable included all participants with viable PK data for analysis.||days||Standard Deviation|Mean
693435|NCT01414855|Secondary|Pharmacokinetics (PK): Maximum Concentration Observed (Cmax) for Obinutuzumab|Blood was collected for PK Parameters. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in micrograms per milliliter (μg/mL).|Cycle 1 Day 1 pre and post dose, Days 3,5, Day 8 pre and post-dose, Day 15 pre-dose. Cycle 8 Day 1 pre and post-dose, Days 5,8,12|PK-Evaluable included all participants with viable PK data for analysis.||μg/mL||Standard Deviation|Mean
693436|NCT01414855|Secondary|Number of Participants With Grade 3 to 4 Infusion-Related (IRR) Adverse Events (AE) in Participants Receiving Shorter Duration Infusion (SDI)|"SDI 120 is a shorter duration infusion of 120 minutes and SDI 90 is shorter duration infusion of 90 minutes.
Grade 3 IRR AE: Prolonged (e.g., not rapidly responsive to symptomatic medication and/or brief interruption of infusion); recurrence of symptoms following initial improvement; hospitalization indicated for clinical sequelae.
Grade 4 IRR AE: Life-threatening consequences; urgent intervention indicated."|From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days)|Participants from the Safety population, all randomized participants who received at least 1 dose of study drug, who received shorter duration infusions.||participants|||Number
693437|NCT01414855|Secondary|Percentage of Participants With Adverse Events as a Measure of Safety|An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug or other protocol-imposed intervention. Preexisting conditions that worsened during the study were reported as adverse events.|From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days)|Safety population included all randomized participants who received study drug.||percentage of participants|||Number
693438|NCT01414855|Secondary|Duration of Response (DOR)|DOR is defined as first occurrence of documented response (CR or PR) until the first occurrence of relapse or progression or death of any cause.|From the first dose of study treatment to response assessment (Up to 28 months)|All participants with data available. Participants who had not progressed, relapsed, or died at the time of analysis, the participants was censored for duration of response at the date of the last valid response assessment.||months||Full Range|Median
693439|NCT01414855|Secondary|Progression-Free Survival (PFS) as Assessed by the Investigator|PFS was defined as the time from the date of the first dose of study treatment until the date of disease progression, relapse, or death from any cause.|From the first dose of study treatment to PFS assessment (Up to 28 months)|All participants. Patients who had not progressed, relapsed or died at the time of analysis were censored on the date of last valid disease assessment. If no tumor assessments were performed after the baseline visit, the patient was censored for PFS at the date after the first dose of study treatments.||months||Full Range|Median
693440|NCT01414855|Secondary|Overall Response Rate (ORR) as Assessed by the IRF at the End of Treatment|Overall response rate was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) according to the Revised Response Criteria for Malignant Lymphoma (Cheson et al., 2007). Disease response was evaluated by the IRF using CT scans, PET scans and pertinent clinical information. CR is the disappearance of all evidence of disease. PR is at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites.|From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days)|All participants||percentage of participants||95% Confidence Interval|Number
693441|NCT01414855|Secondary|Complete Response (CR) Rate as Assessed by the Independent Review Facility (IRF) at the End of Treatment|Complete response rate is defined as the percentage of participants with Complete Response (CR) according to the Revised Response Criteria for Malignant Lymphoma (Cheson et al., 2007). Disease response was evaluated by the IRF using CT scans, PET scans and pertinent clinical information. CR is the disappearance of all evidence of disease.|From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days)|All participants.||percentage of participants||95% Confidence Interval|Number
693442|NCT01414855|Primary|Overall Response Rate (ORR) as Assessed by the Investigator at the End of Treatment|Overall response rate was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) according to the Revised Response Criteria for Malignant Lymphoma (Cheson et al., 2007). Disease response was evaluated by the investigator using regular clinical and laboratory examinations, FDG-PET and computed tomography (CT). CR is the disappearance of all evidence of disease. PR is at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites.|From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days)|All participants||percentage of participants||95% Confidence Interval|Number
693443|NCT01414855|Primary|Complete Response (CR) Rate as Assessed by the Investigator at the End of Treatment|Complete response rate is defined as the percentage of participants with Complete Response (CR) according to the Revised Response Criteria for Malignant Lymphoma (Cheson et al., 2007). Disease response was evaluated by the investigator using regular clinical and laboratory examinations, fluorodeoxyglucose-positron emission tomography (FDG-PET) and computed tomography (CT). CR is the disappearance of all evidence of disease.|From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days)|All participants.||percentage of participants||95% Confidence Interval|Number
693444|NCT01414634|Primary|Number of Adverse Events||3 months after treatment|||Number of AE|||Number
693445|NCT01414634|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability||12 months||||||
693446|NCT01414413|Secondary|Adult Mortality|Comparison between study arms of non-traumatic and HIV-related adult (15-49) mortality rates during the first 6 months of the HIV-testing intervention|The first 6-months following availability of home-based HIV testing||||||
693447|NCT01414413|Secondary|Adherence to ART|Comparison between study arms of the proportion of HIV-positive participants who are adherent to ART during the 1-year study period|First 6-months following availability of home-based HIV testing||||||
693450|NCT01414413|Secondary|Uptake of Home-based HIV Testing|Comparison between study arms of the proportion of all resident adults who request HIV testing (either as standard HTC or as supervised HIV self-testing) from the resident community counsellor during the first year of the study.|The first 6-months following home assessment and initiation of ART being made available|||participants|||Number
693451|NCT01414413|Primary|ART Initiation|Comparison between study arms of the proportion of all resident adults (per capita, and irrespective of HIV status or participation in home-based HIV testing intervention) who initiate ART during the first 6 months of the home-based HIV-testing intervention.|First six months following introduction of home-based HIV testing|||participants|||Number
693452|NCT01412983|Secondary|Overall Comfort|The mean difference in comfort-related symptoms/complaints scores between lens groups. Rated on a scale of 0-100 with 100 being the most favorable score.|One week|All eligible dispensed eyes||units on a scale|Participants|Standard Deviation|Least Squares Mean
693453|NCT01412983|Primary|Visual Acuity|The mean difference in high contrast logMAR, over all lens visual acuities (VAs) between lens groups.|One week|All eligible dispensed eyes||LogMAR|Participants|Standard Deviation|Least Squares Mean
693454|NCT01414244|Secondary|Stool Consistency|Bristol Stool Scale The Bristol Stool Scale characterizes stool characteristics and ranges from a minimum score of 1 with depicts hard or constipated stool to a maximum score of 7 which is watery or diarrheal stools. In this trial, stool that is less than 7 is better and depicts a good outcome.|Baseline and 8 weeks following therapy|||units on a scale (1-7)||Standard Deviation|Mean
693455|NCT01414244|Secondary|Stool Frequency|Baseline and 8 week at the conclusion of therapy|Baseline and 8 weeks following therapy|||stools per day||Standard Deviation|Mean
693456|NCT01414244|Secondary|Intestinal Permeability|The secondary outcome measure will be a change in intestinal permeability from baseline to 8 weeks at the conclusion of therapy. Intestinal permeability is measured by the urinary lactulose/mannitol ratio following ingestion of a solution of lactulose and mannitol.|baseline and 8 weeks following therapy|||lactulose/mannitol (L/M)||Standard Deviation|Mean
693457|NCT01414244|Primary|Change in the Irritable Bowel Symptom Severity Scale|The primary outcome measure will be a change in the Irritable Bowel Symptom Severity Scale (IBS-SS) from baseline to 8 weeks at the conclusion of therapy. The IBS-SS scale ranges from 0 to 500 (worst). A decrease in 50 or greater in the IBS-SS is considered a positive response.|baseline and 8 weeks following therapy|||units on a scale||Standard Deviation|Mean
693458|NCT01414205|Secondary|Pharmacodynamics: Number of Participants With Peripheral Blood B-cell Recovery|Blood was sent to a central laboratory for the evaluation of cluster of differentiation 19 (CD19) by flow cytometry. B-cell recovery was defined as a CD19 result ≥ 0.07 × 10^9/L, where CD19 was previously depleted. B-cell recovery was only considered possible following the last dose of study treatment. The number of participants with B-cell recovery from End of Treatment to 6 months of Follow-up is reported in two categories: Recovery with Progressive Disease (PD) [PD before B-cell recovery or PD within 45 days after recovery] or Recovery without PD. PD required one of the following: 50% increase in the absolute number of circulating lymphocytes, Appearance of new palpable lymph nodes, 50% increase in the longest diameter of any previous site of lymphadenopathy, 50% increase in the enlargement of the liver and/or spleen or Transformation to a more aggressive histology.|Up to 4 years, 5 months|Participants from the Safety Evaluable Population, all randomized participants who received at least one dose of study drug, with B-Cell depletion.||Participants|||Number
693459|NCT01414205|Secondary|Pharmacodynamics: Number of Participants With Peripheral Blood B-cell Depletion|Blood was sent to a central laboratory for the evaluation of cluster of differentiation 19 (CD19) by flow cytometry. B-cell depletion was defined as a CD19 result < 0.07 × 10^9/L after at least one dose of study drug has been administered.|Up to 4 years, 5 months|Participants from the Safety Evaluable Population, all randomized participants who received at least one dose of study drug, who had data available for this outcome measure.||Participants|||Number
693460|NCT01414205|Secondary|PK: Serum Concentrations of Obinutuzumab (Follow-Up Visits)|Blood serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in micrograms per milliliter (μg/mL).|Months 3, 6, 9, and 12|All randomized participants who received study drug with PK data available for analysis. Participants with insufficient data points for PK estimation were excluded.||μg/mL||Standard Deviation|Mean
693461|NCT01414205|Secondary|PK Parameter: Terminal Half-Life (t1/2)|Blood was collected for PK Parameters before and after dose administration on Day 1 of Cycle 8. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA). T1/2 was reported in Days.|Day 148 (pre-infusion, at end of infusion, 5, 8 and 12 days after start of infusion)|All randomized participants who received study drug with PK data available for analysis. Participants with insufficient data points for PK estimation were excluded.||Days||Geometric Coefficient of Variation|Geometric Mean
693462|NCT01414205|Secondary|PK Parameter: Volume of Distribution at Steady State (Vss)|Blood was collected for PK Parameters before and after dose administration on Day 1 of Cycle 8. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA). Vss is reported in liters.|Day 148 (pre-infusion, at end of infusion, 5, 8 and 12 days after start of infusion)|All randomized participants who received study drug with PK data available for analysis. Participants with insufficient data points for PK estimation were excluded.||Liters||Geometric Coefficient of Variation|Geometric Mean
693463|NCT01414205|Secondary|PK Parameter: Clearance at Steady State (CLss)|Blood was collected for PK Parameters before and after dose administration on Day 1 of Cycle 8. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA). CLss is reported in milliliters per day (mL/day).|Day 148 (pre-infusion, at end of infusion, 5, 8 and 12 days after start of infusion)|All randomized participants who received study drug with PK data available for analysis. Participants with insufficient data points for PK estimation were excluded.||mL/day||Geometric Coefficient of Variation|Geometric Mean
693478|NCT01414192|Primary|Rate of Cardiovascular (CV) Events|Number of participants who experienced myocardial infarction, acute coronary syndrome, unstable angina, ischemic stroke, revascularization procedure, fatal stroke, and/or sudden death was recorded. The number of events was divided by the total number of patient-years calculated for each treatment group to produce the rate of CV events per 1000 patient years.|up to 48 months|All participants with available data for endpoint.||Events per 1000 patient-years||95% Confidence Interval|Number
693464|NCT01414205|Secondary|PK Parameter: Area Under the Serum Concentration-Time Curve Between Dosing Interval Tau (AUCt )|Blood was collected for PK Parameters before and after dose administration on Day 1 of Cycle 8. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in day times micrograms per milliliter (day*μg/mL).|Day 148 (pre-infusion, at end of infusion, 5, 8 and 12 days after start of infusion)|All randomized participants who received study drug with PK data available for analysis. Participants with insufficient data points for PK estimation were excluded.||day*μg/mL||Geometric Coefficient of Variation|Geometric Mean
693465|NCT01414205|Secondary|PK Parameter: Maximum Serum Concentration (Cmax)|Blood was collected for Pharmacokinetic (PK) Parameter Cmax after dose administration on Day 1 of Cycle 8. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in micrograms per milliliter (μg/mL).|Day 148 (at end of infusion)|All randomized participants who received study drug with PK data available for analysis.||μg/mL||Geometric Coefficient of Variation|Geometric Mean
693466|NCT01414205|Secondary|Percentage of Participants With Adverse Events Leading to Study Discontinuation|An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution.|Up to 4 years, 5 months|Safety population included all randomized participants who received at least 1 dose of study drug.||Percentage of participants|||Number
693467|NCT01414205|Secondary|Percentage of Participants With Adverse Events of Interest|Adverse Events of interest for this study were: serious infusion related reactions during or within 24 hours of infusion, serious neutropenia, serious infection, tumor lysis syndrome and Hepatitis B reactivation.|Up to 4 years, 5 months|Safety population included all randomized participants who received at least 1 dose of study drug.||Percentage of participants|||Number
693468|NCT01414205|Secondary|Percentage of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. A SAE was any AE that was one of the following: fatal, life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the investigational product or considered a significant medical event by the investigator. Additional information about AEs can be found in the Adverse Event Section.|Up to 4 years, 5 months|Safety population included all randomized participants who received at least 1 dose of study drug.||Percentage of participants|||Number
693469|NCT01414205|Secondary|Number of Participants Surviving at End-of-Study||Up to 4 years, 5 months|Intent-to-treat population included all randomized participants.||Participants|||Number
693470|NCT01414205|Secondary|Duration of Response||Up to 4 years, 5 months||||||
693471|NCT01414205|Secondary|Progression-free Survival (PFS)|PFS was defined as the time from the randomization to the first occurrence of progression or death, whichever occurred first.|Up to 4 years, 5 months|Intent-to-treat population included all randomized participants.||Months||95% Confidence Interval|Median
693472|NCT01414205|Primary|Objective Response Rate (ORR)|ORR was defined as the percentage of participants with complete response (CR), CR with incomplete marrow recovery (CRi) or partial response (PR) as assessed by the investigator according to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) guidelines two months after last treatment. CR required: blood lymphocytes < 4 x 10^9/Liter (L), absence of lymphadenopathy (≤ 1.5 centimeter (cm) in long axis by Computed Tomography), no hepatomegaly or splenomegaly, absence of disease, Neutrophils > 1.5 x 10^9/L, Platelets > 100 x 10^9/L, Hemoglobin >11 g/dL, bone marrow normal and lymphoid nodules absent. CRi was CR with incomplete marrow recovery. PR required: 50% decrease in peripheral blood lymphocyte count, 50% reduction in lymphadenopathy, 50% reduction of liver and/or spleen enlargement if enlarged at baseline, Neutrophils > 1.5 x 10^9/L or > 50% of pretreatment value, Platelets > 100 x 10^9/L or 50% of pretreatment value and Hemoglobin > 11 g/dL or > 50% of pretreatment value.|Week 32|Intent-to-treat population included all randomized participants.||Percentage of participants|||Number
693473|NCT01414192|Secondary|Mortality Rate|The number of participants who died from any cause was recorded. The number of deaths was then extrapolated to produce the number of deaths per 100,000 patient-years.|up to 48 months|All enrolled participants with available data.||Deaths per 100,000 patient-years||95% Confidence Interval|Number
693474|NCT01414192|Secondary|Percentage of Participants With at Least 1 Discontinuation of Study Drug|The percentage of participants who stopped study drug at least once during the study period was recorded and summarized.|up to 48 months|All enrolled participants with available data.||Percentage of Participants|||Number
693475|NCT01414192|Secondary|Percentage of Participants Who Continued Treatment for 12, 24, 36, and 48 Months|Participants' data reviewed and the number of participants who had continued treatment for 12, 24, 36, and 48 months was recorded.|up to 48 months|All enrolled participants with available data. The ezetimibe monotherapy with or without previous lipid-lowering treatment groups were combined for this outcome.||Percentage of Participants|||Number
693476|NCT01414192|Secondary|Percentage of Participants With CV Risk Factors|Enrolled participants' data were reviewed for presence of CV risk factors that included smoking, alcohol & substance abuse, high blood pressure, Type 1 and Type 2 diabetes mellitus, cholesterol level, hypertriglyceridemia, body mass index, cardiovascular disease history, family history of early cardiovascular disease. The sum of all risk factors was tabulated for each participant and totals were summarized by group.|At enrollment (baseline)|All enrolled participants with available data||Percentage of Participants|||Number
693477|NCT01414192|Secondary|Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) Levels at 12 Months|LDL-C levels at baseline and after 12 months of treatment were compared and the percentage change was recorded. In the model, it is assumed that the 5th and 95th percentiles represent the minimum and maximum effect of treatment, respectively.|Baseline and Month 12|All participants with available data for endpoint. The ezetimibe plus statin and ezetimibe/simvastatin arms were combined for this outcome.||Percentage Change||Full Range|Mean
693479|NCT01414166|Secondary|Percent Change From Baseline in Apolipoprotein A-I (Apo A-I) at Week 16|The percentage change from baseline in participants' Apo A-I was to be evaluated at study Week 16.|Baseline and Week 16|Due to early study termination, this efficacy endpoint was not analyzed.|||||
693482|NCT01414166|Secondary|Percent Change From Baseline in the Ratio of Total Cholesterol (TC) to HDL-C at Week 16|The percentage change from baseline in the ratio of TC to HDL-C was to be evaluated at study Week 16.|Baseline and Week 16|Due to early study termination, this efficacy endpoint was not analyzed.|||||
693483|NCT01414166|Secondary|Percent Change From Baseline in Non-HDL-C at Week 16|The percentage change from baseline in participants' non-HDL-C was to be calculated at study Week 16.|Baseline and Week 16|Due to early study termination, this efficacy endpoint was not analyzed.|||||
693484|NCT01414166|Secondary|Percent Change From Baseline in Triglycerides (TG) at Week 16|The percentage change from baseline in participants' TG level was to be evaluated at study Week 16.|Baseline and Week 16|Due to early study termination, this efficacy endpoint was not analyzed.|||||
693485|NCT01414166|Secondary|Percent Change From Baseline in HDL-C at Week 16|The percentage change from baseline in the participants' HDL-C was to be evaluated at study Week 16.|Baseline and Week 16|Due to early study termination, this efficacy endpoint was not analyzed.|||||
693486|NCT01414166|Secondary|Percent Change From Baseline in the Ratio of LDL-C to High-Desity Lipoprotein Cholesterol (HDL-C) at Week 16|The percentage from baseline in the participants' ration of LDL-C to HDL-C was to be evaluated at study Week 16.|Baseline and Week 16|Due to early study termination, this efficacy endpoint was not analyzed|||||
693487|NCT01414166|Primary|Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) Averaged Across Week 12 and Week 16|The percentage change from baseline in the participants' LDL-C was to be evaluated and averaged across treatment Week 12 and Week 16.|Baseline and Weeks 12 to 16|Due to early study termination, this efficacy endpoint was not analyzed.|||||
693488|NCT01414153|Secondary|Proportion of Subjects With Adverse Events.||Baseline to Day 120|||percentage of subjects|||Number
693489|NCT01414153|Secondary|Proportion of Subjects With ETDRS BCVA of 20/40 or Better.|Visual function was assessed using the ETDRS protocol, for which numerical scores range from 0 to 100 (roughly equivalent to 20/10 vision as measured by Snellen). A higher score represents better functioning. A positive number represents an increase in number of letters read correctly. 20/40 Snellen corresponds to a range of 69-73 letters by ETDRS.|Baseline to Day 120|||percentage of subjects||80% Confidence Interval|Number
693490|NCT01414153|Secondary|Proportion of Subjects Losing 3 Lines or More in ETDRS BCVA.|Visual function was assessed using the ETDRS protocol, for which numerical scores range from 0 to 100 (roughly equivalent to 20/10 vision as measured by Snellen). A higher score represents better functioning. A positive number represents an increase in number of letters read correctly. One line is equivalent to 5 letters, so a loss of 3 lines is a loss of 15 letters.|Baseline to Day 120|||percentage of subjects||80% Confidence Interval|Number
693491|NCT01414153|Secondary|Proportion of Subjects Gaining Greater Than or Equal to 0, 5, 10 and 15 Letters on the ETDRS Chart.|Visual function was assessed using the ETDRS protocol, for which numerical scores range from 0 to 100 (roughly equivalent to 20/10 vision as measured by Snellen). A higher score represents better functioning. A positive number represents an increase in number of letters read correctly.|Baseline to Day 120|||percentage of subjects||80% Confidence Interval|Number
693492|NCT01414153|Secondary|Mean Change in CNV Lesion Area as Determined by Fluorescein Angiography (FA).||Baseline to Day 120|ITT population||mm^2||Standard Error|Least Squares Mean
693493|NCT01414153|Secondary|Mean Change in Central Subfield Retinal Thickness||Baseline to Day 120|ITT population||μM||Standard Error|Least Squares Mean
693494|NCT01414153|Primary|Mean Change in Best Corrected Visual Acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS)|Visual function was assessed using the ETDRS protocol, for which numerical scores range from 0 to 100 (roughly equivalent to 20/10 vision as measured by Snellen). A higher score represents better functioning. A positive number represents an increase in number of letters read correctly.|Baseline to Day 120|Intent-to-treat (ITT) Population||letters||Standard Deviation|Least Squares Mean
693495|NCT01414114|Secondary|Percent Change From Baseline in Phosphorus During the Efficacy Period|Baseline was defined as the average of 3 predialysis PTH results obtained within 3 weeks of and prior to the first dose of study drug. The efficacy period (defined as the period from 14 days prior to and 3 days after the last dose of study drug) value was the mean of the prehemodialysis values obtained during that period.|Baseline and the efficacy period, defined as from 14 days prior to and 3 days after the last dose of study drug (approximately days 68 - 85 for participants who completed 12 weeks of treatment)|Modified intent-to-treat population with available data at both time points||percent change||Standard Deviation|Mean
693496|NCT01414114|Secondary|Percent Change From Baseline in Corrected Calcium During the Efficacy Period|Baseline was defined as the average of 3 predialysis PTH results obtained within 3 weeks of and prior to the first dose of study drug. The efficacy period (defined as the period from 14 days prior to and 3 days after the last dose of study drug) value was the mean of the prehemodialysis values obtained during that period.|Baseline and the efficacy period, defined as from 14 days prior to and 3 days after the last dose of study drug (approximately days 68 - 85 for participants who completed 12 weeks of treatment)|Modified intent-to-treat population with available data at both time points||percent change||Standard Deviation|Mean
693497|NCT01414114|Secondary|Percentage of Participants With PTH ≤ 300 pg/mL During the Efficacy Period|The efficacy period (defined as the period from 14 days prior to and 3 days after the last dose of study drug) value was the mean of the prehemodialysis values obtained during that period.|The efficacy period, defined as from 14 days prior to and 3 days after the last dose of study drug (approximately days 68 - 85 for participants who completed 12 weeks of treatment)|Modified intent-to-treat population with available data||percentage of participants||95% Confidence Interval|Number
693498|NCT01414114|Secondary|Percentage of Participants With ≥ 30% Reduction in PTH From Baseline During the Efficacy Period|The efficacy period (defined as the period from 14 days prior to and 3 days after the last dose of study drug) value was the mean of the prehemodialysis values obtained during that period.|Baseline and the efficacy period, defined as from 14 days prior to and 3 days after the last dose of study drug (approximately days 68 - 85 for participants who completed 12 weeks of treatment)|Modified intent-to-treat population with available data||percentage of participants||95% Confidence Interval|Number
693572|NCT01412801|Secondary|Percentages of Infants Who Experienced Unsolicited Adverse Events|Safety in Infants was assessed in terms of the number of subjects who experienced Unsolicited Adverse Events since birth to study termination|Birth to Study Termination, for up to 24 weeks|Safety Set (Unsolicited AEs, Infants)||percentages of Infant subjects|||Number
693499|NCT01414114|Primary|Percent Change From Baseline in Parathyroid Hormone (PTH) During the Efficacy Period|Baseline was defined as the average of 3 predialysis PTH results obtained within 3 weeks of and prior to the first dose of study drug. The efficacy period (defined as the period from 14 days prior to and 3 days after the last dose of study drug) value was the mean of the prehemodialysis values obtained during that period.|Baseline and the efficacy period, defined as from 14 days prior to and 3 days after the last dose of study drug (approximately days 68 - 85 for participants who completed 12 weeks of treatment)|The modified intent-to-treat population (all participants who were randomized and received treatment) with available data at both time points.||percent change||Standard Deviation|Mean
693500|NCT01414036|Secondary|Use of Other Tobacco Treatment Support|self-report of all tobacco treatment support received, including support from non-study sources, including the internet, during the study period.|3 months|14 out of the 23 in control group completed 3 month survey and 19 out of 24 in patient navigation group completed the 3 month survey.||participant|||Number
693501|NCT01414036|Secondary|Stage of Change With Regard to Smoking Cessation|Stage of change is assessed at baseline and 3 months. Three months after study entry, 7 of patient navigation-intervention participants who had initially said that they did not have a time frame in mind for quitting reported that they now had a time frame in mind for quitting, relative to 1 of ETC-control participants.|3 months|14 out of the 23 in control group completed 3 month survey and 19 out of 24 in patient navigation group completed the 3 month survey.||participant|||Number
693502|NCT01414036|Primary|Engagement in Smoking Cessation Treatment|This is a dichotomous variable, Y/N, based on a) completion of > 1 quit line counseling session (based on self-report) OR b) > 1 PCP visit in which smoking cessation treatment is discussed (patient self-report and medical record review of progress notes) OR c) Completion of > 1 session of a BMC smoking cessation group (medical record review).|3 months|14 out of the 23 in control group completed 3 month survey and 19 out of 24 in patient navigation group completed the 3 month survey.||participant|||Number
693503|NCT01414010|Primary|Bacteria Prevalence in Stool|"The most prevalent bacterial genera within the study population
Before Treatment: Average of Day -7 and Day 0 During Treatment: Average of Days 10 and 14 After Treatment: Average of Days 21, 28, and 56"|Day 0 to 56|The investigators expanded their studies on the probiotic (Saccharomyces boulardii) to constitute a full, separate study. Reference: NCT01473368.||percentage of bacterial genera in stool||Standard Deviation|Mean
693504|NCT01413958|Secondary|Rhinoconjunctivitis Quality of Life Questionnaire With Standardized Activities (RQLQ)|"The RQLQ is a disease-specific quality of life questionnaire developed to measure the physical, emotional, and social problems in adults with rhinoconjunctivitis. Questions were divided into 7 domains: sleep (3 questions), non-hay fever symptoms (7 questions), practical problems (3
questions), nasal symptoms (4 questions), eye symptoms (4 questions), and activities (3 questions), and emotions (4 questions). Individual items within the RQLQ are equally weighted. The questionnaire is analyzed directly from the scores recorded and the results are expressed as the mean score for each of the domains (i.e., domain scores range from 0 to 6). Six represents the greatest impairment and 0 represents the least impairment. Overall quality of life score is the mean score for all domains."|Up to Day 8|The Intent-To-Treat Population was used in this analysis. There were 285 evaluable participants for the Placebo Group at Day 8.||Scores on a scale||Standard Deviation|Mean
693505|NCT01413958|Secondary|Mean Change From Baseline for the Evening Instantaneous Symptom Assessment Scores for Each Day During the Treatment Period.|The instantaneous assessment is a self-evaluation of the symptom severity at the moment of the assessment prior to the next dose. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The daily nasal congestion score was calculated from data captured daily (evening) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = worst symptoms. The average of individual instantaneous nasal scores was reported as the daily instantaneous nasal congestion score for each day of the treatment period.|Baseline and Day 1, 2, 3, 4, 5, 6, and 7|Intent-To-Treat Population was used in this analysis. For the Phenylephrine Group, there were 288 evaluable participants on Days 5 and 7, 287 on Days 1, 3, 4 and 286 on Days 2 and 6. For the Placebo Group, there were 286 evaluable participants on Days 1, 2, 3, 5, 6 and 285 on Day 7 and 284 on Day 4.||Scores on a scale||Standard Deviation|Mean
693506|NCT01413958|Secondary|Mean Change From Baseline for the Morning Instantaneous Symptom Assessment Scores for Each Day During the Treatment Period|The instantaneous assessment is a self-evaluation of the symptom severity at the moment of the assessment prior to the next dose. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The daily nasal congestion score was calculated from data captured daily (morning) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = worst symptoms. The average of individual instantaneous nasal scores was reported as the daily instantaneous nasal congestion score for each day of the treatment period.|Baseline and Day 2, 3, 4, 5, 6, and 7|The Intent-To-Treat Population was used in this analysis. For the Phenylephrine Group, there were 288 evaluable participants on Days 1, 2, 3, 4, 5, 7 and 286 evaluable participants at Day 6. For the Placebo Group, there were 287 evaluable participants on Day 1, 286 on Days 3, 5, 6 and 285 on Days 2, 4, 7.||Scores on a scale||Standard Deviation|Mean
693507|NCT01413958|Secondary|Mean Change From Baseline for the Evening Reflective Symptom Assessment Scores for Each Day During the Treatment Period|The reflective assessment is a self-evaluation of the symptom severity over the preceding 12 hours. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The nasal congestion score was calculated from data captured daily (evening) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = severe symptoms. The average of individual reflective nasal scores were reported as the daily reflective nasal congestion score for each day of the treatment period.|Baseline and Day 1, 2, 3, 4, 5, 6, and 7|The Intent-To-Treat Population was used in this analysis. For the Phenylephrine Group, there were 288 evaluable participants on Day 5, 287 on Days 1, 3, 4, 6 and 286 on Day 2. For the Placebo Group, there were 287 evaluable participants on Day 1, 286 on Days 2, 5, 6, 285 on Days 3 and 7 and 284 on Day 4.||Scores on a scale||Standard Deviation|Mean
699290|NCT00002540|Secondary|T0 (Baseline) PSA Screening Results|Prostate-Specific Antigen (PSA) result.|T0 (at study entry)|All males in the Prostate Screening arm who had a PSA screen at T0 were analyzed.||Participants|||Number
693508|NCT01413958|Secondary|Mean Change From Baseline for the Morning Reflective Symptom Assessment Scores for Each Day During the Treatment Period.|The reflective assessment is a self-evaluation of the symptom severity over the preceding 12 hours. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The nasal congestion score was calculated from data captured daily (morning) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = severe symptoms. The average of individual reflective nasal scores were reported as the daily reflective nasal congestion score for each day of the treatment period.|Baseline and Day 2, 3, 4, 5, 6, and 7|The Intent-To-Treat Population was used in this analysis. For the Phenylephrine Group, there were 288 evaluable participants on Days 2 - 5 and 287 on Day 6. For the Placebo Group, there were 287 evaluable participants on Day 1, 286 on Days 2, 5, and 6 and 285 on Days 3, 4, and 7.||Scores on a scale||Standard Deviation|Mean
693509|NCT01413958|Secondary|Mean Change From Baseline in Morning Predose Instantaneous Nasal Congestion Symptom Score|The instantaneous assessment is a self-evaluation of the symptom severity at the moment of the assessment prior to the next dose. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The nasal congestion score was calculated from data captured daily (morning) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = worst symptoms. The average of individual morning instantaneous nasal scores was reported as the daily morning instantaneous nasal congestion score over the entire treatment period.|Baseline and Days 1-7|Efficacy analysis was performed on the intent-to-treat population (all randomized participants who received at least 1 dose of study medication). Number of participants evaluable in the placebo group at baseline was 287 and for the treatment period was 286.||Scores on a scale||Standard Deviation|Mean
693510|NCT01413958|Secondary|Day 7 Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score|The instantaneous assessment is a self-evaluation of the symptom severity at the moment of the assessment prior to the next dose. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The nasal congestion score was calculated from data captured twice daily (morning and evening) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = worst symptoms). The average of individual instantaneous nasal scores was reported as the daily instantaneous nasal congestion score over the entire treatment period.|Baseline and Day 7|Efficacy analysis was performed on the intent-to-treat population (all randomized participants who received at least 1 dose of study medication). Number of participants evaluable in the placebo group at baseline was 287 and at Day 7 was 285.||Scores on a scale||Standard Deviation|Mean
693511|NCT01413958|Secondary|Time to Maximal Phenylephrine Effect|The time to maximal phenylephrine effect was defined as the earliest time that the nasal congestion symptom score in the Phenylephrine treatment group demonstrated the greatest numerical difference from the Placebo treatment group in change from baseline. The mean change from baseline scores for a Phenylephrine treatment arm and for the Placebo treatment arm at each timepoint of the treatment period (Day 1 morning, Day 1 evening, etc) was calculated. The difference between the Phenylephrine treatment arm and Placebo treatment arm mean at each timepoint of the treatment period was calculated. The time to maximal phenylephrine effect was the first timepoint at which the difference between the Phenylephrine treatment arm and the Placebo treatment arm was greatest. The results for the Placebo treatment arm are not presented as the result of this outcome measure is only relevant for the Phenylephrine treatment group.|Baseline up to Day 7|All participants in the intent-to-treat population (all randomized participants who received at least 1 tablet of study medication).||Days|||Number
693512|NCT01413958|Secondary|Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score Per Day|The instantaneous assessment is a self-evaluation of the symptom severity at the moment of the assessment prior to the next dose. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The daily nasal congestion score was calculated from data captured twice daily (morning and evening) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = worst symptoms. The average of individual instantaneous nasal scores was reported as the daily instantaneous nasal congestion score for each day of the treatment period.|Baseline and Day 1, 2, 3, 4, 5, 6, 7|The Intent-To-Treat Population was used in this analysis. For the Phenylephrine Group, there were 287 evaluable participants on Day 1 and 288 on Day 2 - 7. For the Placebo Group, there were 286 evaluable participants on Days 1, 2, 3, 4, 5, 6 and 285 on Day 7.||Scores on a scale||Standard Deviation|Mean
693513|NCT01413958|Secondary|Mean Change From Baseline in Daily Reflective Nasal Congestion Score Per Day|The reflective assessment is a self-evaluation of the symptom severity over the preceding 12 hours. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The nasal congestion score was calculated from data captured twice daily (morning and evening) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = severe symptoms. The average of individual reflective nasal scores were reported as the daily reflective nasal congestion score for each day of the treatment period.|Baseline and Day 1, 2, 3, 4, 5, 6, and 7|Efficacy analysis was performed on the intent-to-treat population (all randomized participants who received at least 1 dose of study medication). For the Phenylephrine Group, there were 287 evaluable participants on Day 1 and 288 on Days 2 - 7. For Placebo Group, there were 286 evaluable participants on Days 1, 2, 3, 4, 5, 6, and 285 on Day 7.||Scores on a scale||Standard Deviation|Mean
693524|NCT01413542|Secondary|Assess Tissue Type Plasminogen Activator (tPA) Release|Following measurement of FBF, samples will be obtained to determine the effect of ACE inhibition and/or DPP4 inhibition on tPA release in response to bradykinin and substance P (SP) (group 1)|Blood for analysis of tPA release was obtained 60 minutes after sitagliptin (DPP4 inhibition) vs. placebo and after each assessment of FBF (see primary outcome measure)|||estimate of difference (ng/min/100mL)||95% Confidence Interval|Number
693573|NCT01412801|Secondary|Percentages of Subjects Who Experienced Unsolicited Adverse Events|Safety was assessed in terms of the number of subjects who experienced Unsolicited Adverse Events after receiving one dose of the GBS Trivalent Vaccine|Day 1 to Study Termination, for up to 24 weeks|Safety Set (Unsolicited AEs, Maternal Subjects)||percentages of subjects|||Number
693514|NCT01413958|Secondary|Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score|The instantaneous assessment is a self-evaluation of the symptom severity at the moment of the assessment prior to the next dose. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The daily nasal congestion score was calculated from data captured twice daily (morning and evening) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = worst symptoms. The average of individual instantaneous nasal scores was reported as the daily instantaneous nasal congestion score over the entire treatment period.|Baseline and Days 1-7|Efficacy analysis was performed on the intent-to-treat population (all randomized participants who received at least 1 dose of study medication). Number of participants evaluable in the placebo group at baseline was 287 and for the treatment period was 286.||Scores on a scale||Standard Deviation|Mean
693515|NCT01413958|Secondary|Mean Change From Baseline in the Evening Reflective Symptom Assessment Score|The reflective assessment is a self-evaluation of the symptom severity over the preceding 12 hours. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The daily evening nasal congestion score was calculated from data captured daily (evening) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = worst symptoms). The average of individual reflective nasal scores was reported as the daily reflective nasal congestion score over the entire treatment period.|Baseline and Days 1-7|Efficacy analysis was performed on the intent-to-treat population (all randomized participants who received at least 1 dose of study medication). Number of participants evaluable in the placebo group at baseline was 287 and for the treatment period was 286.||Scores on a scale||Standard Deviation|Mean
693516|NCT01413958|Secondary|Mean Change From Baseline in the Morning Reflective Symptom Assessment Score|The reflective assessment is a self-evaluation of the symptom severity over the preceding 12 hours. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The daily morning nasal congestion score was calculated from data captured daily (morning) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = worst symptoms. The average of individual reflective nasal scores was reported as the daily reflective nasal congestion score over the entire treatment period.|Baseline and Days 1-7|Efficacy analysis was performed on the intent-to-treat population (all randomized participants who received at least 1 dose of study medication). Number of participants evaluable in the placebo group at baseline was 287 and for the treatment period was 286.||Scores on a scale||Standard Deviation|Mean
693517|NCT01413958|Primary|Mean Change From Baseline in Daily Reflective Nasal Congestion Score|The reflective assessment is a self-evaluation of the symptom severity over the preceding 12 hours. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The nasal congestion score was calculated from data captured twice daily (morning and evening) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = absent symptoms (no sign/symptom evident), 1 = mild symptoms (sign/symptom clearly present, but minimal awareness; easily tolerated), 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), and 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping). The average of individual reflective nasal scores was reported as the daily reflective nasal congestion score over the entire treatment period.|Baseline and Days 1-7|Efficacy analysis was performed on the intent-to-treat population (all randomized participants who received at least 1 dose of study medication). Number of participants evaluable in the placebo group at baseline was 287 and for the treatment period was 286.||Scores on a scale||Standard Deviation|Mean
693518|NCT01413750|Secondary|Maximum Tolerated Dose (MTD) (Phase I)|The highest dose tested in which fewer than 33% of patients experience an attributable DLT to the study drug, when at least 6 patients are treated at that dose and are evaluable for toxicity. The MTD is one dose level below the lowest dose in which 33% or more of the patients experience a DLT. The MTD is based on the first cycle of therapy. The recommended Phase II dose is generally the MTD, although secondary considerations of toxicity and dose reductions on subsequent cycles and other secondary considerations may result in the recommended Phase II dose being below the MTD.|4 weeks from start of treatment, up to 1 year|||mg|||Number
693519|NCT01413750|Secondary|Dose Limiting Toxicity (DLT) (Phase I)|DLT is defined as any grade III or higher non-hematological toxicity except nausea, vomiting or alopecia. Nausea or vomiting (> grade 2) that last longer than 48 hours despite maximal medical therapy. Absolute neutrophil count < 1000/uL lasting longer than 7 days. Grade 4 thrombocytopenia (platelet < 25,000/uL). Grade 3 or 4 neutropenia associated with sepsis or fever > 38 C. Delay in starting cycle 2 by more than 2 weeks due to toxicity.Abnormal non-hematological laboratory criteria (Grade 3 or higher) will be considered a DLT, if clinically significant and drug-related. If baseline value is elevated prior to drug therapy, an increase will not be considered a DLT unless there is an elevation by more than 2 grades, and it is of clinical significance. Dose escalation schedule for vorinostat: 600 mg QD; 800 mg QD.|4 weeks from start of treatment, up to 1 year|||participants with DLTs|||Number
693520|NCT01413750|Primary|Progression-free Survival (PFS)|"Estimated using the product-limit method of Kaplan and Meier.
PFS defined as time from randomization to progression or death due to any cause.
Progression defined as Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions."|From first day of treatment to the first observation of disease progression or death due to any cause, assessed up to 1 year|Due to early termination phase II portion of the study did not reach planned accrual.||months||95% Confidence Interval|Median
693521|NCT01413542|Secondary|Effect of Treatment (DPP4 Inhibition vs. Placebo) on Venous GLP-1 Levels in Response to Arterial GLP-1 Infusion||Blood for analysis of GLP-1 levels was obtained one hour after sitagliptin (DPP4 inhibition) vs. placebo administration and after each dose of GLP-1|||pmol/L||Standard Error|Mean
693522|NCT01413542|Secondary|Effect of Treatment (ACE or DPP4 Inhibition, or Combined) on Norepinephrine (NE) Release (Arterial Venous Gradient) in Response to Substance P (SP)||Blood for analysis of norepinephrine (NE) release was obtained 60 minutes after sitagliptin (DPP4 inhibition) vs. placebo and after each assessment of FBF (see primary outcome measure)|||pg/mL||Standard Error|Mean
693525|NCT01413542|Primary|The Effect of Enalaprilat (ACE Inhibition), Sitagliptin (DPP4 Inhibition), or the Combination on the Vasodilator Response (Forearm Blood Flow) to Substance P (SP) and Bradykinin (Group 1) or Glucagon Like Peptide-1 and Brain Naturetic Peptide (Group 2).|Forearm blood flow (FBF) was measured by strain gauge plethysmography at the completion of each dose of intra-arterial peptide. A dose response curve was therefore constructed for each vasoactive peptide substrate. The effect of sitagliptin (DPP4 inhibition) vs. placebo and enalaprilat (ACE inhibition) vs. vehicle on the forearm blood flow response to each peptide could then be determined.|60 minutes post-placebo or sitagliptin (DPP4 inhibition) and over last 2 minutes of each 5 min infusion per peptide dose (30 min washout between peptides); sequence repeated with enalaprilat (ACE inhibition) or vehicle|In Group 1: Peptide 1=Max dose Bradykinin; Peptide 2=Substance P (SP) In Group 2: Peptide 1=GLP-1; Peptide 2=BNP (FBF expressed as percent change for both peptides) ACE inhibition=enalaprilat DPP4 inhibition=sitagliptin||estimate of difference(ml/min/100ml FBF)||95% Confidence Interval|Mean
693526|NCT01413516|Secondary|Adverse Events|Adverse effects assessed by structured checklist with choices of not present, mild, moderate, severe graded by FDA toxicity criteria.|4 weeks||12/2017||||
693527|NCT01413516|Secondary|Stage of Change||4 weeks||12/2017||||
693528|NCT01413516|Secondary|Time to First Cigarette Post-hospitalization||4 weeks||12/2017||||
693529|NCT01413516|Secondary|Medication Compliance Rate|This will be measured using two biomarkers collected from blood, urine, and saliva samples.|4 weeks after initial assessment||12/2017||||
693530|NCT01413516|Secondary|Nicotine Withdrawal and Urges to Smoke||4 weeks||12/2017||||
693531|NCT01413516|Primary|7 Day Point Prevalence Abstinence From All Forms of Tobacco|Self report of being quit for 7 continuous days at the time of the 4-week follow-up survey confirmed by saliva cotinine or urine anabasine verification.|4 weeks after beginning study|||participants|||Number
693532|NCT01413360|Secondary|The Change in Serum Interleukin 22 Level From Baseline to 12 Weeks|Serum interleukin 22(IL-22)level after 12 weeks of high vitamin C administration and Baseline IL-22 level|Baseline and 12 weeks|||pg/mL||Full Range|Median
693533|NCT01413360|Primary|The Change in Serum Alanine Aminotransferase Level From Baseline to 12 Weeks|Serum alanine aminotransferase (ALT) level after 12 weeks of high dose vitamin C administration and Baseline serum ALT level|Baseline and 12 weeks|||IU/L||Full Range|Median
693534|NCT01413204|Secondary|Safety and Tolerability Assessed by Adverse Events, Hypoglycemic Events, Laboratory Tests, 12-lead ECG and Vital Signs||Week 24||||||
693535|NCT01413204|Secondary|Change in Postprandial Plasma Glucose, Insulin and Urinary Glucose Excretion After a 75 g Oral Glucose Tolerance Test||Week 24||||||
693536|NCT01413204|Secondary|Change in Blood Pressure||Week 24||||||
693537|NCT01413204|Secondary|Change in Body Weight||Week 24||||||
693538|NCT01413204|Secondary|Change in Fasting Plasma Glucose||Week 24||||||
693539|NCT01413204|Primary|Change in Hemoglobin A1c (A1C) From Baseline (NGSP Value)||baseline and 24 weeks|Full analysis set, last observation carried forward||percent HbA1C||Standard Error|Least Squares Mean
693540|NCT01413191|Secondary|Tumor Shrinkage for All Efficacy-evaluable Patients||Up to 2 years||||||
693541|NCT01413191|Secondary|Overall Survival (OS)||Up to 2 years||||||
693542|NCT01413191|Secondary|Progression-free Survival (PFS)||Up to 2 years||||||
693543|NCT01413191|Secondary|Duration of Response|Duration of response will be summarized by using descriptive statistics. Median duration of response will be estimated by using the Kaplan-Meier method.|From the date criteria are first met for complete or partial response until the first date of documented progression, assessed up to 2 years||||||
693544|NCT01413191|Secondary|Durable Response Rate (i.e., the Proportion of Subjects With a Confirmed Complete or Partial Response ≥ 6 Months in Duration)|The durable response rate will be presented and the adjusted 95% confidence interval will be calculated.|Up to 2 years||||||
693545|NCT01413191|Secondary|Disease Control Rate (i.e., the Proportion of Subjects With a Confirmed Complete or Partial Response of Any Duration or Stable Disease ≥3 Months in Duration)|The disease control rate will be presented and the adjusted 95% confidence interval will be calculated.|Up to 2 years||||||
693546|NCT01413191|Primary|Response Rate (% Participants With Complete or Partial Response)|Response rate is the percentage of subjects with a confirmed complete or partial response using revised Response Evaluation Criteria in Solid Tumors (RECIST) where changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria: Complete Response (CR): Disappearance all target lesions; pathological lymph nodes reduction in short axis to <10 mm. Partial Response (PR): 30% or > decrease in sum diameters of target lesions, reference baseline sum diameters. Progressive Disease (PD): 20% or > increase in sum diameters of target lesions, reference smallest sum on study (includes baseline sum if smallest on study); and sum must demonstrate absolute increase of 5+ mm. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum diameters while on study.|Baseline to 2 years|One participant was not evaluable for response assessment.||participants|||Number
693547|NCT01412957|Secondary|Maximum Post-baseline Change From Baseline in Corrected QT (QTc) Interval|QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle as measured by electrocardiogram (ECG). QTc is the QT interval corrected for heart rate. To evaluate the effect of panitumumab treatment on the QTc interval length among participants treated with panitumumab, ECGs were collected at the following time points from participants randomized to panitumumab arm at a limited number of sites: Week 1 prior to the first panitumumab infusion (Baseline) and within 30 minutes following the end of the first infusion of panitumumab (Cmax), Week 7 after 3 doses of panitumumab (steady state), and at the safety follow-up visit. The ECGs were submitted for independent central review to calculate the reported QTc interval. QTc was calculated using both the Bazett correction (QTcB) and the Fridericia correction (QTcF).|Baseline (pre-dose), Week 1 and Week 7 (post-dose) and 4 weeks after the last dose (Safety Follow-up visit)|QTc Analysis Set is defined as the subset of participants in the Safety Analysis Set who received at least one panitumumab dose and were enrolled at the limited number of sites participating in QTc evaluation and had baseline and at least 1 post-baseline QTc assessment.||msec||Standard Deviation|Mean
693802|NCT01410357|Primary|Montgomery Asberg Depression Rating Scale (MADRS) at 60 Weeks|The MADRS is a 10-item depression severity scale widely utilized in studies with patients with serious mental illness. Possible scores range from 0 to 60 with higher scores indicating worse depression.|60 weeks|||scores on a scale||Standard Deviation|Mean
693548|NCT01412957|Secondary|Number of Participants With Adverse Events (AEs)|The severity of each AE was graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (Grade 1 = Mild; 2 = Moderate (discomfort enough to cause interference with usual activity); 3 = Severe (incapacitating with inability to work or do usual activity); 4 = Life-threatening and 5 = Fatal), with the exception of the skin-or nail-related AEs which were graded using a CTCAE version 3.0 with modifications. A serious AE was defined as an AE that met at least 1 of the following criteria: • fatal, • life-threatening, • required in-patient hospitalization or prolongation of existing hospitalization, • resulted in persistent or significant disability/incapacity, • congenital anomaly/birth defect, and/or • other medically important serious event. Treatment-related AEs (TRAEs) are those the investigator considered there was reasonable possibility that the event might have been caused by study drug.|From first dose until 30 days after last dose; median safety reporting periods were 4.2 months and 2.2 months for panitumumab plus BSC arm and BSC alone arm, respectively.|Safety Analysis Set (all randomized participants)||participants|||Number
693549|NCT01412957|Secondary|Objective Response Rate in Participants With Wild-type RAS|Objective response rate is defined as the percentage of participants with either a complete response (CR) or partial response (PR) per RECIST version 1.1. Radiographic tumor assessments and investigator’s assessment of response were performed at Week 4, Week 8, and then every 8 weeks until disease progression (radiographic or clinical progression). CR: Disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR: At least a 30% decrease in the size of target lesions with no progression of non-target lesions and no new lesions, or, the disappearance of all target lesions with persistence of one or more non-target lesions not qualifying for either CR or PD and no new lesions.|Response was assessed at Week 4, Week 8, and then every 8 weeks until the data cut-off date of 10 June 2014. The median follow-up time was 36.1 weeks (panitumumab plus BSC: 43.7 weeks; BSC alone: 23.6 weeks).|Wild-type RAS Efficacy Analysis Set||percentage of participants||95% Confidence Interval|Number
693550|NCT01412957|Secondary|Objective Response Rate|Objective response rate (ORR) is defined as the percentage of participants with either a complete response (CR) or partial response (PR) per RECIST version 1.1. Radiographic tumor assessments and investigator’s assessment of response were performed at Week 4, Week 8, and then every 8 weeks until disease progression (radiographic or clinical progression). CR: Disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR: At least a 30% decrease in the size of target lesions with no progression of non-target lesions and no new lesions, or, the disappearance of all target lesions with persistence of one or more non-target lesions not qualifying for either CR or PD and no new lesions.|Response was assessed at Week 4, Week 8, and then every 8 weeks until the data cut-off date of 10 June 2014. The median follow-up time was 34.9 weeks (panitumumab plus BSC: 41.0 weeks; BSC alone: 25.5 weeks).|ITT analysis set||percentage of participants||95% Confidence Interval|Number
693551|NCT01412957|Secondary|Progression Free Survival (PFS) in Participants With Wild-type RAS|"PFS was defined as the time from the randomization date to the date of disease progression per RECIST version 1.1 or death.
Progressive disease (PD): At least a 20% increase in the size of target lesions compared with the smallest size since treatment started and an absolute increase of at least 5 mm, any new lesions, or an increase in size of non-target lesions thought be ≥ 20% with an absolute increase of at least 5 mm, or significant increase in pleural effusions, ascites or other fluid collections with cytologic proof of malignancy. Participants who were alive and did not meet the criteria for progression by the analysis data cut-off date were censored at their last evaluable disease assessment date."|From randomization to the last on-study or long-term follow-up visit, as of the data cut-off date of 10 June 2014. The median follow-up time was 36.1 weeks (panitumumab plus BSC: 43.7 weeks; BSC alone: 23.6 weeks).|Wild-type RAS Efficacy Analysis Set||months||95% Confidence Interval|Median
693552|NCT01412957|Secondary|Overall Survival in Participants With Wild-type RAS|A secondary efficacy endpoint was overall survival in participants with wild-type rat sarcoma viral oncogene homolog (RAS) (without mutation in exons 2 [codons 12 and 13], 3 [codons 59 and 61], and 4 [codons 117 and 146] of KRAS and neuroblastoma RAS viral oncogene (NRAS)). In participants with wild-type RAS, RAS mutation status was defined by KRAS exon 2 mutation status per clinical trial assay testing and mutation status of KRAS exon 3 and 4 and NRAS exons 2, 3 and 4 per Sanger bi-directional sequencing. Overall survival was defined as the time from the randomization date to the date of death. Participants who had not died by the analysis data cut-off date were censored at their last contact date and participants with survival data obtained after the planned analysis data cut-off date had survival censored at the cut-off date.|From randomization to the last on-study or long-term follow-up visit, as of the data cut-off date of 10 June 2014. The median follow-up time was 36.1 weeks (panitumumab plus BSC: 43.7 weeks; BSC alone: 23.6 weeks).|Wild-type RAS Efficacy Analysis Set (subset of participants in the ITT Analysis Set without mutation in exon 2, 3, and 4 of KRAS or NRAS)||months||95% Confidence Interval|Median
693553|NCT01412957|Secondary|Progression-free Survival|Progression-free survival (PFS) was defined as the time from the randomization date to the date of disease progression per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 or death. Progressive disease (PD): At least a 20% increase in the size of target lesions compared with the smallest size since treatment started and an absolute increase of at least 5 mm, any new lesions or an increase in size of non-target lesions thought be ≥ 20% and an absolute increase of at least 5 mm, or significant increase in pleural effusions, ascites or other fluid collections with cytologic proof of malignancy. Participants who were alive and did not meet the criteria for progression by the analysis data cut-off date were censored at their last evaluable disease assessment date.|From randomization to the last on-study or long-term follow-up visit, as of the data cut-off date of 10 June 2014. The median follow-up time was 34.9 weeks (panitumumab plus BSC: 41.0 weeks; BSC alone: 25.5 weeks).|ITT Analysis Set||months||95% Confidence Interval|Median
693574|NCT01412801|Secondary|Percentages of Subjects With Solicited Systemic AEs|Safety was assessed in terms of the number of subjects with solicited systemic AEs after receiving one dose of the GBS Trivalent Vaccine|From 6 Hours to Day 7 After Each Vaccination, for up to 24 weeks|Safety Set (Solicited AEs, Maternal Subjects)||percentages of Subjects|||Number
693575|NCT01412801|Secondary|Percentages of Subjects With Solicited Local Adverse Events (AEs)|Safety was assessed in terms of the number of subjects with solicited local AEs after receiving one dose of the GBS Trivalent Vaccine|From 6 Hours to Day 7 After Each Vaccination, for up to 24 weeks|Safety Set (Solicited AEs, Maternal Subjects)||percentage of Subjects|||Number
693554|NCT01412957|Primary|Overall Survival|Overall survival was defined as the time from the randomization date to the date of death. Participants who had not died by the analysis data cut-off date were censored at their last contact date and participants with survival data obtained after the planned analysis data cut-off date had survival censored at the cut-off date.|From randomization to the last on-study or long-term follow-up visit, as of the data cut-off date of 10 June 2014. The median follow-up time was 34.9 weeks (panitumumab plus BSC: 41.0 weeks; BSC alone: 25.5 weeks).|Intent to Treat (ITT) Analysis Set (all randomized participants); participants in the ITT Analysis Set were required to have wild-type KRAS exon 2 (codons 12 and 13, alleles G12A, G12D, G12R, G12C, G12S, G12V, or G13D) per protocol.||months||95% Confidence Interval|Median
693555|NCT01412944|Secondary|Relationship Between Response to AIN457 and Failed Response to Previous Biologic Psoriasis Therapy|This outcome measure was not analyzed due to the small sample size of the study (43 participants).|End of study||||||
693556|NCT01412944|Secondary|Number of Participants Who Developed Anti-secukinumab Antibodies|The development of anti-secunimubab anti-bodies would decrease a participant’s ability to respond to secukinumab treatment.|Baseline, weeks 12, 24 and 40|Participants from full analysis set (FAS), who had values at baseline and post-baseline, were included in the analysis. The FAS included all participants to whom treatment was assigned.||Number of participants|||Number
693557|NCT01412944|Secondary|Mean Percent Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment (From 0 to 100)|The EQ-5D is an instrument used to assess a participant's health status. The instrument includes a descriptive profile and a visual analog scale (VAS). The descriptive profile includes 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension had 3 response levels: no problems, some problems and severe problems. The VAS is a vertical scale that assesses the health status from 0 (worst possible health state) to 100 (best possible health state). This outcome measures the percent change in VAS score. Positive mean percent changes indicate improvement.|Baseline, weeks 8, 16, 24, 32 and 40|The FAS population was used for this analysis. The FAS included all participants to whom treatment was assigned. Only participants from the FAS, who had values at a given week, were included in the analysis for that week.||Percent change||Standard Deviation|Mean
693558|NCT01412944|Secondary|Mean Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Scores|"The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). Not relevant is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative mean percentage change from baseline indicates improvement."|Baseline, weeks 8, 16, 24, 32 and 40|The FAS population was used for this analysis. The FAS included all participants to whom treatment was assigned. Only participants from the FAS, who had post-baseline values at the given weeks, were included in the analysis for that week.||Percent change||Standard Deviation|Mean
693559|NCT01412944|Secondary|Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) of 0 or 1|"The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral warts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). Not relevant is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A DLQI of 0 or 1 indicates no impairment or little impairment, respectively. A negative mean percentage change from baseline indicates improvement."|Baseline, Week 8, Week 16, Week 24, Week 32,up to Week 40|The full analysis set (FAS) population was used for this analysis. The FAS included all participants to whom treatment was assigned. Only participants from the FAS, who had post-baseline values at the given weeks, were included in the analysis for that week.||Percentage of participants|||Number
693560|NCT01412944|Secondary|Percentage of Participants in Each IGA Mod 2011 Score Category|The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.|Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40|The full analysis set (FAS) population was used for this analysis. The FAS included all participants to whom treatment was assigned. Only participants from the FAS, who had post-baseline values at the given weeks, were included in the analysis for that week.||Percentage of participants|||Number
693561|NCT01412944|Secondary|Mean Percent Change From Baseline in PASI Scores|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). A negative mean percentage change indicates improvement.|Baseline, weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40|The full analysis set (FAS) population was used for this analysis. The FAS included all participants to whom treatment was assigned. Only participants from the FAS, who had post-baseline values at the given weeks, were included in the analysis for that week.||Percent change||Standard Deviation|Mean
693571|NCT01412801|Primary|Geometric Mean Antibody Transfer Ratio Between Infant Antibody Level (μg/mL) and Maternal Antibody Level (μg/mL), for GBS Serotypes Ia, Ib and III at Delivery/Birth.|The Geometric mean transfer ratio of GBS-specific Ab against serotypes Ia, Ib and III at delivery is calculated as the geometric mean of the pairwise ratios between the antibody concentrations from infant at birth and to maternal serum concentration at delivery.|Day of delivery/birth|Full Analysis Set (FAS)-Maternal and Infant Subjects: Maternal subjects provided at least one evaluable serum sample result at delivery; infant subjects provided at least one evaluable sample result at birth (from cord blood, or peripheral blood within 72 hours when cord blood was unavailable).||Ratios||95% Confidence Interval|Geometric Mean
693562|NCT01412944|Secondary|Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.|Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40|The full analysis set (FAS) population was used for this analysis. The FAS included all participants to whom treatment was assigned. Only participants from the FAS, who had values at a given week, were included in the analysis for that week.||Percentage of participants|||Number
693563|NCT01412944|Primary|Percentage of Participants (Who Achieved a Partial Response Defined as ≥ 50% But < 75% Improvement in PASI After 12 Weeks of Treatment in Study AIN457A2304) With Investigator's Global Assessment Model 2011 (IGA Mod 2011) 0 or 1 Response|The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. Treatment success was defined as achievement of IGA mod 2001 score of 0 or 1.|Week 8|The full analysis set (FAS) population was used for this analysis. The FAS included all participants to whom treatment was assigned. Only participants from the FAS, who had week 8 values, were included in the analysis.||Percentage of participants|||Number
693564|NCT01412944|Primary|Percentage of Participants (Who Achieved a Partial Response Defined as ≥ 50% But < 75% Improvement in Psoriasis Area and Severity Index (PASI) After 12 Weeks of Treatment in Study AIN457A2304) With 75% Improvement From Baseline in PASI|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).|Week 8|The full analysis set (FAS) population was used for this analysis. The FAS included all participants to whom treatment was assigned. Only participants from the FAS, who had week 8 values, were included in the analysis.||Percentage of participants|||Number
693565|NCT01412918|Secondary|Percentage of Participants Which Showed Presence of SCN9 Gene Expression.|Percentage of participants with and without tinnitus provided a genetic sample via saliva to determine presence of SCN9 gene expression.|Single visit (day 1), evaluated at the time of the genetic collection.|||% of participants with gene expression|||Number
693566|NCT01412918|Primary|Determine the Percentage of Participants for Which the Inhibitor™ Tinnitus Masking Device Effected Tinnitus Perception|Determine percentage of particpants with a change in tinnitus perception to evaluate the effectiveness of the Inhibitor™ Tinnitus Masking Device.|Single visit (day 1), assessed the day of visit|||percentage of participants|||Number
693567|NCT01412879|Secondary|Overall Survival (OS)|Measured from date of registration to date of death due to any cause. Patients last known to be alive and are censored at date of last contact.|Up to 2 years|All eligible patients who started treatment were included in the analysis.||percentage of participants||95% Confidence Interval|Number
693568|NCT01412879|Secondary|Response Rate (Complete and Partial Response)|Complete Response (CR) is a complete disappearance of all disease with the exception of the following. If no PET scan or when the PET scan was positive before therapy, a post-treatment residual mass of any size is permitted if it is PET negative. If the PET scan was negative before therapy, all nodal masses at baseline must have regressed. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow (BM) must be negative if positive at baseline. Normalization of markers. Partial Response (PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. If PET scan or when the PET scan was positive before therapy, PET should be positive in at least one previously involved site.|Up to 9 months|All eligible patients who started treatment were included in the analysis.||percentage of participants||95% Confidence Interval|Number
693569|NCT01412879|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|Up to 8 months (Assessed at the beginning of each cycle of treatment, at restaging, and at post transplant.)|Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 4.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.||Participants|||Number
693570|NCT01412879|Primary|Progression-Free Survival (PFS) at 2 Years|Disease progression is defined using the 2007 revised Cheson et al. criteria that is at least 50% increase in sum of the product of the diameters (SPD) of target measurable nodal lesions over the smallest sum observed, or >= 50% increase in greatest transverse diameter (GTD) of any nodal > 1 cm in shortest axis, or >= 50% increase in the SPD of other target measurable lesions over the smallest sum observed, any new bone marrow involvement, any new lesion, lymph node with long axis is > 1.5 cm or if both long and short axes are > 1 cm, PET positive if patients with no pretreatment PET scan or when PET scan was positive before therapy. Progression-free survival is measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.|Up to 2 years|All eligible patients who started treatment were included in the analysis||percentage of participants||95% Confidence Interval|Number
693923|NCT01409837|Primary|Proportion of Sperm Cells With Abnormal Morphology (%)|Proportion (per cent) of sperm cells with abnormal appearance|Week 96|All the patients randomized into each group was analyzed on the basis of intention-to-treat.||per cent||Standard Deviation|Geometric Mean
693576|NCT01412801|Secondary|Percentages of Maternal Subjects With The Enzyme-linked Immunosorbent Assay (ELISA) Antibody Levels for GBS Serotypes Ia, Ib and III Above a Specific Threshold at Delivery|Immunogenicity was measured in terms of the percentages of maternal subjects with ELISA Antibody Levels for GBS Serotypes Ia, Ib and III Above a Specific Threshold after receiving one dose of GBS Trivalent Vaccine.Threshold values of 0.1, 0.2, 0.5, 1, 2, 3, 5, and 8 μg/mL were used for serum concentrations for maternal subjects.|Day of Delivery|FAS (Maternal Subjects)||Percentage of maternal subjects|||Number
693577|NCT01412801|Secondary|Vaccine Induced Maternal Serotype Specific GBS Antibody Levels for GBS Serotypes Ia, Ib and III at Day 1, 15, 31 and at Delivery|Immunogenicity was measured as Geometric Mean Concentration of Antibody levels for GBS Serotypes Ia, Ib and III after receiving one dose of GBS Trivalent Vaccine.|Day 1, 15, 31 and at Delivery|FAS (Maternal Subjects in the Exposed Population) who -Secondary objective serum GMC: provided at least one evaluable sample result at day 1 (prior to vaccination), day 15, day 31, or at delivery;- Secondary objective kinetics: provided at least one evaluable serum sample at day 1 (prior to vaccination), day 15, day 31, and at delivery.||µg/mL||95% Confidence Interval|Geometric Mean
693578|NCT01412801|Primary|Geometric Mean Concentrations (GMCs) of Antibodies in Maternal Subjects and Infants at Delivery/Birth|GMCs of Group B Streptococcus (GBS)-specific Abs against serotypes Ia, Ib and III in mothers and in infants at delivery/birth are presented.|Day of delivery/birth|Full Analysis Set (FAS)-Maternal and Infant Subjects: Maternal subjects provided at least one evaluable serum sample result at delivery; infant subjects provided at least one evaluable sample result at birth (from cord blood, or peripheral blood within 72 hours when cord blood was unavailable).||μg/mL||95% Confidence Interval|Geometric Mean
693579|NCT01412541|Secondary|Secondary Safety #8 - Percentage of Subjects With Readmission for Cardiovascular Events at 12 Months.|Percentage of subjects with Readmission for cardiovascular events at 12 Months|12 Months|The sample size were subjects that had data available for analysis of the endpoint.||percentage of participants||95% Confidence Interval|Number
693580|NCT01412541|Secondary|Secondary Safety #8 - Percentage of Subjects With Readmission for Cardiovascular Events at 6 Months.|Percentage of subjects with Readmission for cardiovascular events at 6 Months|6 Months|The sample size were subjects that had data available for analysis of the endpoint.||percentage of participants||95% Confidence Interval|Number
693581|NCT01412541|Secondary|Secondary Safety #8 - Percentage of Subjects With Readmission for Cardiovascular Events at 1 Month.|Percentage of subjects with Readmission for cardiovascular events at 1 Month|1 Month|The sample size were subjects that had data available for analysis of the endpoint.||percentage of participants||95% Confidence Interval|Number
693582|NCT01412541|Secondary|Secondary Safety #7 - Percentage of Subjects With Major Vascular Complications at 12 Months.|Percentage of subjects with Major vascular complications at 12 Months|12 Months|The sample size were subjects that had data available for analysis of the endpoint.||percentage of participants||95% Confidence Interval|Number
693583|NCT01412541|Secondary|Secondary Safety #7 - Percentage of Subjects With Major Vascular Complications at 6 Months.|Percentage of subjects with Major vascular complications at 6 Months|6 Months|The sample size were subjects that had data available for analysis of the endpoint.||percentage of participants||95% Confidence Interval|Number
693584|NCT01412541|Secondary|Secondary Safety #7 - Percentage of Subjects With Major Vascular Complications at 1 Month.|Percentage of subjects with Major vascular complications at 1 Month|1 Month|The sample size were subjects that had data available for analysis of the endpoint.||percentage of participants||95% Confidence Interval|Number
693585|NCT01412541|Secondary|Secondary Safety #6 - Percentage of Subjects With Reintervention for Treatment of Thrombosis of the Target Vessel or Embolization to Its Distal Vasculature at 12 Months.|Percentage of subjects with Reintervention for treatment of thrombosis of the target vessel or embolization to its distal vasculature at 12 Months|12 Months|The sample size were subjects that had data available for analysis of the endpoint.||percentage of participants||95% Confidence Interval|Number
693586|NCT01412541|Secondary|Secondary Safety #6 - Percentage of Subjects With Reintervention for Treatment of Thrombosis of the Target Vessel or Embolization to Its Distal Vasculature at 6 Months.|Percentage of subjects with Reintervention for treatment of thrombosis of the target vessel or embolization to its distal vasculature at 6 Months|6 Months|The sample size were subjects that had data available for analysis of the endpoint.||percentage of participants||95% Confidence Interval|Number
693587|NCT01412541|Secondary|Secondary Safety #6 - Percentage of Subjects With Reintervention for Treatment of Thrombosis of the Target Vessel or Embolization to Its Distal Vasculature at 1 Month.|Percentage of subjects with Reintervention for treatment of thrombosis of the target vessel or embolization to its distal vasculature at 1 Month|1 Month|The sample size were subjects that had data available for analysis of the endpoint.||percentage of participants||95% Confidence Interval|Number
693588|NCT01412541|Secondary|Secondary Safety #5 - Percentage of Subjects With Target Vessel Revascularization (TVR) at 12 Months.|Percentage of subjects with Target Vessel Revascularization (TVR) at 12 Months|12 Months|The sample size were subjects that had data available for analysis of the endpoint.||percentage of participants||95% Confidence Interval|Number
693589|NCT01412541|Secondary|Secondary Safety #5 - Percentage of Subjects With Target Vessel Revascularization (TVR) at 6 Months.|Percentage of subjects with Target Vessel Revascularization (TVR) at 6 Months|6 Months|The sample size were subjects that had data available for analysis of the endpoint.||percentage of participants||95% Confidence Interval|Number
693590|NCT01412541|Secondary|Secondary Safety #5 - Percentage of Subjects With Target Vessel Revascularization (TVR) at 1 Month.|Percentage of subjects with Target Vessel Revascularization (TVR) at 1 Month|1 Month|The sample size were subjects that had data available for analysis of the endpoint.||percentage of participants||95% Confidence Interval|Number
693591|NCT01412541|Secondary|Secondary Safety #4 - Percentage of Subjects With Amputation (Above the Ankle)-Free Survival (AFS) 12 Months.|Percentage of subjects with Amputation (above the ankle)-Free Survival (AFS) 12 Months|12 Months|The sample size were subjects that had data available for analysis of the endpoint.||percentage of participans||95% Confidence Interval|Number
693592|NCT01412541|Secondary|Secondary Safety #4 - Percentage of Subjects With Amputation (Above the Ankle)-Free Survival (AFS) 6 Months.|Percentage of subjects with Amputation (above the ankle)-Free Survival (AFS) 6 Months|6 Months|The sample size were subjects that had data available for analysis of the endpoint.||percentage of partiipants||95% Confidence Interval|Number
693593|NCT01412541|Secondary|Secondary Safety #4 - Percentage of Subjects With Amputation (Above the Ankle)-Free Survival (AFS) 1 Month.|Percentage of subjects with Amputation (above the ankle)-Free Survival (AFS) 1 Month|1 Month|The sample size were subjects that had data available for analysis of the endpoint.||percentage of participants||95% Confidence Interval|Number
693594|NCT01412541|Secondary|Secondary Safety #3 - Percentage of Subjects With All-cause Death at 12 Months.|Percentage of subjects with All-cause death at 12 Months|12 Months|The sample size were subjects that had data available for analysis of the endpoint.||percentage of participants||95% Confidence Interval|Number
693595|NCT01412541|Secondary|Secondary Safety #3 - Percentage of Subjects With All-cause Death at 6 Months.|Percentage of subjects with All-cause death at 6 Months|6 Months|The sample size were subjects that had data available for analysis of the endpoint.||percentage of participants||95% Confidence Interval|Number
693596|NCT01412541|Secondary|Secondary Safety #3 - Percentage of Subjects With All-cause Death at 1 Month.|Percentage of subjects with All-cause death at 1 Month|1 month|The sample size were subjects that had data available for analysis of the endpoint.||percentage of participants||95% Confidence Interval|Number
693597|NCT01412541|Secondary|Secondary Safety #2 - Percentage of Subjects With Composite of Freedom From All-cause Perioperative (≤30 Day) Death and Freedom From the Following at 6 Months: Index Limb Amputation, Index Limb Re-intervention, and Index-limb-related Death.|Percentage of subjects with Composite of freedom from all-cause perioperative (≤30 day) death and freedom from the following at 6 months: index limb amputation, index limb re-intervention, and index-limb-related death.|6 Months|The sample size were subjects that had data available for analysis of the endpoint.||percentage of Participants||95% Confidence Interval|Number
693598|NCT01412541|Secondary|Secondary Safety #2 - Percentage of Subjects With Composite of Freedom From All-cause Perioperative (≤30 Day) Death and Freedom From the Following at 1 Month: Index Limb Amputation, Index Limb Re-intervention, and Index-limb-related Death at 1 Month.|Percentage of subjects with Composite of freedom from all-cause perioperative (≤30 day) death and freedom from the following at 1 Month: index limb amputation, index limb re-intervention, and index-limb-related death at 1 month.|1 Month|The sample size were subjects that had data available for analysis of the endpoint.||percentage of Participants||95% Confidence Interval|Number
693599|NCT01412541|Secondary|Secondary Safety #1 - Percentage of Subjects With Freedom From All-cause Death, Index Limb Amputation Above the Ankle and Target Vessel Revascularization (TVR) (VIVA Safety Endpoint).|Percentage of subjects with Freedom from all-cause death, index limb amputation above the ankle and Target Vessel Revascularization (TVR) (VIVA Safety Endpoint)|30 days|The sample size were subjects that had data available for analysis of the endpoint.||percentage of participants||95% Confidence Interval|Number
693600|NCT01412541|Secondary|Secondary Efficacy #10A - Mean Change in Quality of Life Physical Component and Mental Component of SF-36 v2 From Baseline to 12 Months.|Mean change in quality of life physical component and mental component of SF-36 v2 from baseline to 12 months. The SF-36 v2 United States (US) average normative score is 50, scores can range from 30 (Worst) to 70 (Best).|Baseline and 12 Months|The sample size were subjects that had data available for analysis of the endpoint.||units on a scale||Standard Deviation|Mean
693601|NCT01412541|Secondary|Secondary Efficacy #10A - Mean Change in Quality of Life Physical and Mental Component of SF-36 v2 From Baseline to 6 Months.|Mean change in quality of life physical and mental component of SF-36 v2 from baseline to 6 months. The SF-36 v2 United States (US) average normative score is 50, scores can range from 30 (Worst) to 70 (Best).|Baseline and 6 Months|The sample size were subjects that had data available for analysis of the endpoint.||units on a scale||Standard Deviation|Mean
693602|NCT01412541|Secondary|Secondary Efficacy #10 - Mean Change of the EuorQol (EQ-5D) Index From Baseline to 12 Months.|Mean change of the EuorQol (EQ-5D) index from baseline to 12 months. The EQ-5D index range is 0 to 1.0 with a positive change indicating improvment in health state.|Baseline and 12 Months|The sample size were subjects that had data available for analysis of the endpoint.||units on a scale||Standard Deviation|Mean
693603|NCT01412541|Secondary|Secondary Efficacy #10 - Mean Change of the EuorQol (EQ-5D) Index From Baseline to 6 Months.|Mean change of the EuorQol (EQ-5D) index from baseline to 6 months. The EQ-5D index range is 0 to 1.0 with a positive change indicating improvment in health state.|Baseline and 6 Months|The sample size were subjects that had data available for analysis of the endpoint.||units on a scale||Standard Deviation|Mean
693604|NCT01412541|Secondary|Secondary Efficacy #9 - Mean of Subjects With Change in Six Minute Walk Test Distance From Baseline Through 12 Months.|Mean of subjects with change in Six Minute Walk Test distance from baseline through 12 months|Baseline and 12 Months|The sample size were subjects that had data available for analysis of the endpoint.||meters||Standard Deviation|Mean
693605|NCT01412541|Secondary|Secondary Efficacy #9 - Mean of Subjects With Change in Six Minute Walk Test Distance From Baseline to 6 Months.|Mean of subjects with change in Six Minute Walk Test distance from baseline to 6 months|Baseline and 6 Months|The sample size were subjects that had data available for analysis of the endpoint.||meters||Standard Deviation|Mean
693606|NCT01412541|Secondary|Secondary Efficacy #8 - Mean Differences Between the Total Walking Impairment Questionnaire Score From Baseline to 12 Months.|Mean differences between the total Walking Impairment Questionnaire score from baseline to 12 months. The total score is calculated as the mean of the distance, speed, and stair scores with a range between 0 to 100. A positive change would indicate improvment.|Baseline and 12 Months|The sample size were subjects that had data available for analysis of the endpoint.||units on a scale||Standard Deviation|Mean
693607|NCT01412541|Secondary|Secondary Efficacy #8 - Mean Differences Between the Total Walking Impairment Questionnaire Score From Baseline to 6 Months.|Mean differences between the total Walking Impairment Questionnaire score from baseline to 6 months. The total score is calculated as the mean of the distance, speed, and stair scores with a range between 0 to 100. A positive change would indicate improvment.|Baseline and 6 months|The sample size were subjects that had data available for analysis of the endpoint.||units on a scale||Standard Deviation|Mean
693608|NCT01412541|Secondary|Secondary Efficacy #7 - Mean Difference Between the Baseline and 12 Months of Resting Ankle Brachial Index (ABI).|Mean difference between the baseline and 12 months of resting ankle brachial index (ABI).|Baseline and 12 Months|The sample size were subjects that had data available for analysis of the endpoint.||ratio||Standard Deviation|Mean
699575|NCT00012012|Secondary|Pelvic Tumor Control||From registration to date of pelvic tumor failure or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years.||||||
693609|NCT01412541|Secondary|Secondary Efficacy #7 - Mean Difference Between the Baseline and 6 Months of Resting Ankle Brachial Index (ABI).|Mean difference between the baseline and 6 months of resting ankle brachial index (ABI).|Baseline and 6 Months|The sample size were subjects that had data available for analysis of the endpoint.||ratio||Standard Deviation|Mean
693610|NCT01412541|Secondary|Secondary Efficacy #6 - Percentage of Subjects With Change of Rutherford Classification From Baseline to 12 Months.|Percentage of subjects with change of Rutherford classification from baseline to 12 months Rutherford 0 Asymptomatic, no hemodynamically significant occlusive disease Rutherford 1 Mild claudication Rutherford 2 Moderate claudication Rutherford 3 Severe claudication Rutherford 4 Ischemic rest pain|Baseline and 12 Months|The sample size were subjects that had data available for analysis of the endpoint.||percentage of participants improving|||Number
693611|NCT01412541|Secondary|Secondary Efficacy #6 - Percentage of Subjects With Change of Rutherford Classification From Baseline to 6 Months (%Improved).|"Percentage of subjects with change of Rutherford classification from baseline to 6 months (%Improved).
Rutherford 0 Asymptomatic, no hemodynamically significant occlusive disease Rutherford 1 Mild claudication Rutherford 2 Moderate claudication Rutherford 3 Severe claudication Rutherford 4 Ischemic rest pain"|Baseline and 6 Months|The sample size were subjects that had data available for analysis of the endpoint.||percentage of participants improving|||Number
693612|NCT01412541|Secondary|Secondary Efficacy #5A - Percentage of Subjects With Freedom From Target Lesion Revascularization (TLR) Total (Clinical and DUS/Angiography - Driven) at 12 Months.|Percentage of subjects with Freedom from Target Lesion Revascularization (TLR) Total (Clinical and DUS/Angiography - driven) at 12 Months|12 Month|The sample size were subjects that had data available for analysis of the endpoint.||percentage of participants||95% Confidence Interval|Number
693613|NCT01412541|Secondary|Secondary Efficacy #5A - Percentage of Subjects With Freedom From Target Lesion Revascularization (TLR) Total (Clinical and DUS/Angiography - Driven) at 6 Months.|Percentage of subjects with Freedom from Target Lesion Revascularization (TLR) Total (Clinical and DUS/Angiography - driven) at 6 Months|6 Months|The sample size were subjects that had data available for analysis of the endpoint.||percentage of participants||95% Confidence Interval|Number
693614|NCT01412541|Secondary|Secondary Efficacy #5 - Percentage of Subjects With Freedom From Target Lesion Revascularization (TLR) Clinically-driven at 12 Months.|Percentage of subjects with Freedom from Target Lesion Revascularization (TLR) Clinically-driven at 12 Months|12 Months|The sample size were subjects that had data available for analysis of the endpoint.||percentage of partcipants||95% Confidence Interval|Number
693615|NCT01412541|Secondary|Secondary Efficacy #5 - Percentage of Subject With Freedom From Target Lesion Revascularization (TLR) Clinically-driven at 6 Months.|Percentage of subject with Freedom from Target Lesion Revascularization (TLR) Clinically-driven at 6 Months|6 Months|The sample size were subjects that had data available for analysis of the endpoint.||percentage of participants||95% Confidence Interval|Number
693616|NCT01412541|Secondary|Secondary Efficacy #4 - Percentage of Subjects With Alternative Primary Patency Based on Alternative Definitions of Duplex Ultrasound (DUS) Peak Systolic Velocity Ratio (PSVR) <2.5 Through 12 Months.|Percentage of subjects with Alternative Primary Patency based on alternative definitions of Duplex Ultrasound (DUS) peak systolic velocity ratio (PSVR) <2.5 through 12 Months. DUS PSVR is calculated by dividing the maximum peak systolic velocity (PSV) from the stenosis by the PSV from the nearest segment of normal artery above the site of increase.|12 Months|The sample size were subjects that had data available for analysis of the endpoint.||percentage of participants||95% Confidence Interval|Number
693617|NCT01412541|Secondary|Secondary Efficacy #4 - Percentage of Subjects With Alternative Primary Patency Based on Alternative Definitions of Suplex Ultrasound (DUS) Peak Systolic Velocity Ration (PSVR) <2.5 Through 6 Months.|Percentage of subjects with Alternative Primary Patency based on alternative definitions of Suplex Ultrasound (DUS) peak systolic velocity ration (PSVR) <2.5 through 6 Months. DUS PSVR is calculated by dividing the maximum peak systolic velocity (PSV) from the stenosis by the PSV from the nearest segment of normal artery above the site of increase.|6 Months|The sample size were subjects that had data available for analysis of the endpoint.||percentage of participants||95% Confidence Interval|Number
693618|NCT01412541|Secondary|Secondary Efficacy #3A - Percentage of Subjects With Alternative Primary Patency Based on Alternative Definitions of Duplex Ultrasound (DUS) Peak Systolic Velocity Ration (PSVR) <3.0 Through 12 Months.|Percentage of subjects with Alternative Primary Patency based on alternative definitions of Duplex Ultrasound (DUS) peak systolic velocity ration (PSVR) <3.0 through 12 Months. DUS PSVR is calculated by dividing the maximum peak systolic velocity (PSV) from the stenosis by the PSV from the nearest segment of normal artery above the site of increase.|12 Months|The sample size were subjects that had data available for analysis of the endpoint.||percentage of participants||95% Confidence Interval|Number
693619|NCT01412541|Secondary|Secondary Efficacy #3A - Percentage of Subjects With Alternative Primary Patency Based on Alternative Definitions of Duplex Ultrasound (DUS) Peak Systolic Velocity Ratio (PSVR) <3.0 Through 6 Months.|Percentage of subjects with Alternative Primary Patency based on alternative definitions of Duplex Ultrasound (DUS) peak systolic velocity ratio (PSVR) <3.0 through 6 Months. DUS PSVR is calculated by dividing the maximum peak systolic velocity (PSV) from the stenosis by the PSV from the nearest segment of normal artery above the site of increase.|6 Months|The sample size were subjects that had data available for analysis of the endpoint.||percentage of participants||95% Confidence Interval|Number
693620|NCT01412541|Secondary|Secondary Efficacy #3 - Percentage of Subjects With Alternative Primary Patency Based on Alternative Definitions of Duplex Ultrasound (DUS) Peak Systolic Velocity Ratio (PSVR) <2.0 Through 12 Months.|Percentage of subjects with Alternative Primary Patency based on alternative definitions of duplex ultrasound (DUS) peak systolic velocity ratio (PSVR) <2.0 through 12 Months. DUS PSVR is calculated by dividing the maximum peak systolic velocity (PSV) from the stenosis by the PSV from the nearest segment of normal artery above the site of increase.|12 Months|The sample size were subjects that had data available for analysis of the endpoint.||percentage of participants||95% Confidence Interval|Number
693641|NCT01412333|Secondary|Number of Participants With Adverse Events (AEs)|AEs included infusion related reactions (IRRs) and serious MS relapses, but excluded non-serious MS relapses. Serious Adverse Events (SAEs) included serious MS relapses and serious IRRs.|Baseline up to Week 96|The safety population included all participants who received any study drug.||participants|||Number
704524|NCT00091949|Secondary|Composite Outcome of Fatal or Non-fatal Stroke, Fatal or Non-fatal MI or Episode of Serious Congestive Heart Failure||5 years|||participants|||Number
693621|NCT01412541|Secondary|Secondary Efficacy #3 - Percentage of Subjects With Alternative Primary Patency Based on Alternative Definitions of Duplex Ultrasound Peak Systolic Velocity Ratio (DUS PSVR) <2.0 Through 6 Months.|Percentage of subjects with Alternative Primary Patency based on alternative definitions of duplex ultrasound peak systolic velocity ratio (DUS PSVR) <2.0 through 6 Months. DUS PSVR is calculated by dividing the maximum peak systolic velocity (PSV) from the stenosis by the PSV from the nearest segment of normal artery above the site of increase.|6 Months|.The sample size were subjects that had data available for analysis of the endpoint.||percentage of participants||95% Confidence Interval|Number
693622|NCT01412541|Secondary|Secondary Efficacy #2A - Percentage of Subjects With Secondary Patency Rate at 12 Months (Defined by Core Lab Adjudication).|Percentage of subjects with Secondary Patency Rate at 12 Months (defined by core lab adjudication)|12 Months|The sample size were subjects that had data available for analysis of the endpoint.||percentage of participants||95% Confidence Interval|Number
693623|NCT01412541|Secondary|Secondary Efficacy #2A - Percentage of Subjects With Secondary Patency (Absence of Target Lesion Restenosis by Core Lab Adjudication) at 6 Months.|Percentage of subjects with Secondary Patency (absence of target lesion restenosis by core lab adjudication) at 6 Months|6 Months|The sample size were subjects that had data available for analysis of the endpoint.||percentage of Participants||95% Confidence Interval|Number
693624|NCT01412541|Secondary|Secondary Efficacy #2 - Percentage of Subjects With Duplex Ultrasound Clinical Primary Patency [Freedom From Clinically Driven Target Lesion Revascularization (TLR) and Binary Restenosis] at 12 Months.|Percentage of subjects with duplex ultrasound Clinical Primary Patency [Freedom from Clinically Driven Target Lesion Revascularization (TLR) and binary restenosis] at 12 months|12 Months|The sample size were subjects that had data available for analysis of the endpoint.||percentage of participants||95% Confidence Interval|Number
693625|NCT01412541|Secondary|Secondary Efficacy #2 - Percentage of Subjects With Duplex Ultrasound Clinical Primary Patency [Freedom From Clinically Driven Target Lesion Revascularization (TLR) and Binary Restenosis] at 6 Months.|Percentage of subjects with Duplex Ultrasound Clinical Primary Patency [Freedom from Clinically Driven Target Lesion Revascularization (TLR) and binary restenosis] at 6 months|6 Months|The sample size were subjects that had data available for analysis of the endpoint.||percentage of participants||95% Confidence Interval|Number
693626|NCT01412541|Secondary|Secondary Efficacy #1B - Number of Subjects With Procedural Success.|Number of subjects with Procedural Success defined as attainment of ≤30% residual stenosis in the treatment area by independent core lab analysis without serious adverse events during the index procedure.|During the procedure|Based on number of subjects with Procedural success as identified by the core lab.||participants|||Number
693627|NCT01412541|Secondary|Secondary Efficacy #1A - Number of Subjects With Technical Success.|Number of subjects with Technical Success defined as successful access and deployment of the device and visual estimate of ≤30% diameter residual stenosis during the index procedure without deployment of a bailout stent.|During the procedure|Based on number of subjects with Technical success as identified by the core lab.||participants|||Number
693628|NCT01412541|Secondary|Secondary Efficacy #1 - Number of Devices With Device Success.|Number of devices with Device Success defined on a per device basis, the achievement of successful delivery and deployment of the study device(s) as intended at the intended target lesion, without balloon rupture or inflation/deflation abnormalities and a successful withdrawal of the study system.|During the procedure|Based upon devices used in the study (432 for DCB and 180 for PTA).||devices|Devices||Number
693629|NCT01412541|Primary|Primary Efficacy - Percentage of Subjects With Primary Patency of the Target Lesion at One Year.|Percentage of subjects with Primary patency of the target lesion at one year. Primary patency is defined as freedom from target lesion restenosis (defined by duplex ultrasound core lab adjudication) and target lesion revascularization (TLR).|12 months|Overall, 83.5% (264/316) test DCB subjects and 84.4% (135/160) control PTA subjects were evaluable for the primary efficacy endpoint testing.||percentage of participants||95% Confidence Interval|Number
693630|NCT01412541|Primary|Primary Safety - Percentage of Subjects With Composite of Freedom From All-cause Peri-operative (≤30 Day) Death and Freedom From the Following: Index Limb Amputation, Index Limb Re-intervention, and Index-limb-related Death at 12 Months.|Percentage of subjects with Composite of freedom from all-cause peri-operative (≤30 day) death and freedom from the following: index limb amputation, index limb re-intervention, and index-limb-related death at 12 months.|12 months|Overall, 90.5% (286/316) test DCB subjects and 89.4% (143/160) control PTA subjects were evaluable for primary safety endpoint testing.||percentage of participants||95% Confidence Interval|Number
693631|NCT01412424|Secondary|Percentage of Participants With ≥ 1, 2, or 3 Acromegaly Symptoms at Baseline and at the End of the Extension Treatment Period|Reported is the percentage of participants who had ≥ 1, 2, or 3 of the 5 symptoms of acromegaly (headaches, perspiration, asthenia, swelling of extremities, or joint pain) of any severity (mild, moderate, or severe). This was a post hoc analysis.|Baseline and the end of the extension treatment period (up to 13 months)|Extension intent-to-treat population: All participants who entered the extension treatment period and received any amount of study drug during the extension treatment period.||Percentage of participants|||Number
693632|NCT01412424|Secondary|Percentage of Participants With Improved or Maintained Acromegaly Symptoms at the End of the Extension Treatment Period|The severity (absent, mild, moderate, severe) of the 5 acromegaly symptoms headache, perspiration, asthenia, swelling of extremities, and joint pain was assessed at Baseline and at the end of the extension treatment period. The percentage of participants with improved or maintained (no change) acromegaly symptoms from Baseline at the end of the extension treatment period is reported.|Baseline and the end of the extension treatment period (up to 13 months)|Extension intent-to-treat population: All participants who entered the extension treatment period and received any amount of study drug during the extension treatment period.||Percentage of participants||95% Confidence Interval|Number
693650|NCT01412333|Secondary|Number of T1 Gadolinium (Gd)-Enhancing Lesions as Detected by Brain Magnetic Resonance Imaging (MRI) During the Double-Blind Treatment|The total number of T1 gadolinium-enhancing lesions for all participants in the treatment group was calculated as the sum of the individual number of lesions at Weeks 24, 48, and 96.|Baseline up to week 96|ITT population included all randomized participants in the study.||lesions|||Number
694363|NCT01401582|Secondary|Person With Dementia: Change in Social Support|The F-SozU (Fydrich et al. 2007) will be used to assess social support in several domains|participants will be followed yearly until institutionalisation or death after an expected average of 5 years||05/2017||||
693633|NCT01412424|Secondary|Maintenance of Response During the Extension Treatment Period|Maintenance of an insulin-like growth factor-1 (IGF-1) response during the extension treatment period was defined as the percentage of participants with an IGF-1 concentration < 1.3 times the upper limit of normal at the beginning of the extension treatment period and at the end of the extension treatment period. IGF-1 concentration was determined in serum samples taken at the same visits growth hormone concentration was assessed.|Beginning of the extension treatment period and the end of the extension treatment period (up to 13 months)|Extension intent-to-treat population: All participants who entered the extension treatment period and received any amount of study drug during the extension treatment period.||Percentage of participants||95% Confidence Interval|Number
693634|NCT01412424|Secondary|Percentage of Participants With Specified IGF-1 and GH Concentrations at the Beginning and at the End of the Extension Treatment Period|Percentage of participants with the following serum insulin-like growth factor-1 (IGF-1) and growth hormone (GH) concentrations at the beginning (BETP) and at the end (EETP) of the extension treatment period: IGF-1 < 1.3 times the upper level of normal (ULN) and GH < 5.0 ng/mL, IGF-1 < 1.3 times ULN and GH < 1.0 ng/mL, IGF-1 ≤ 1.0 times ULN and GH < 5.0 ng/mL, IGF-1 ≤ 1.0 times ULN and GH < 2.5 ng/mL, IGF-1 ≤ 1.0 times ULN and GH < 1.0 ng/mL, IGF-1 < 1.3 times ULN, IGF-1 ≤ 1.0 times ULN, GH < 5.0 ng/mL, GH < 2.5 ng/mL, GH < 1.0 ng/mL, IGF-1 ≥ 1.3 times ULN and GH < 2.5 ng/mL, IGF-1 < 1.3 times ULN and GH ≥ 2.5 ng/mL, and IGF-1 ≥ 1.3 times ULN and GH ≥ 2.5 ng/mL. The growth hormone concentration was the mean of 5 fasted GH serum concentrations collected at 30 minute intervals for 2 hours, 2 to 4 hours post-octreotide dose. IGF-1 concentration was determined in serum samples taken at the same visits GH concentration was assessed.|Beginning and the end of the extension treatment period (up to 6 months)|Extension intent-to-treat population: All participants who entered the extension treatment period and received any amount of study drug during the extension treatment period.||Percentage of participants|||Number
693635|NCT01412424|Secondary|Maintenance of Response During the Fixed Dose Phase of the Core Treatment Period|Maintenance of response during the fixed dose phase of the core treatment period was defined as the percentage of participants with an insulin-like growth factor-1 (IGF-1) concentration < 1.3 times the upper limit of normal at the beginning of the fixed dose phase of the core treatment period and at the end of the core treatment period. IGF-1 concentration was determined in serum samples taken at the same visits growth hormone concentration was assessed.|Beginning of the fixed dose phase of the core treatment period and the end of the core treatment period (up to 7 months)|Fixed dose population: All enrolled participants who received any amount of study drug, who had at least 1 IGF-1 or GH assessment after the first dose of octreotide, and who entered the fixed dose phase of the core treatment period.||Percentage of participants|||Number
693636|NCT01412424|Secondary|Percentage of Participants With Specified IGF-1 and GH Concentrations at Baseline and at the End of the Core Treatment Period|Percentage of participants with the following serum insulin-like growth factor-1 (IGF-1) and growth hormone (GH) concentrations at Baseline and at the end of the core treatment period (ECTP): IGF-1 < 1.3 times the upper limit of normal (ULN) and GH < 5.0 ng/mL, IGF-1 < 1.3 times ULN and GH < 1.0 ng/mL, IGF-1 ≤ 1.0 times ULN and GH < 5.0 ng/mL, IGF-1 ≤ 1.0 times ULN and GH < 2.5 ng/mL, IGF-1 ≤ 1.0 times ULN and GH < 1.0 ng/mL, IGF-1 < 1.3 times ULN, IGF-1 ≤ 1.0 times ULN, GH < 5.0 ng/mL, GH < 2.5 ng/mL, GH < 1.0 ng/mL, IGF-1 ≥ 1.3 times ULN and GH < 2.5 ng/mL, IGF-1 < 1.3 times ULN and GH ≥ 2.5 ng/mL, and IGF-1 ≥ 1.3 times ULN and GH ≥ 2.5 ng/mL. The growth hormone concentration was the mean of 5 fasted GH serum concentrations collected at 30 minute intervals for 2 hours, 2 to 4 hours post-octreotide dose. IGF-1 concentration was determined in serum samples taken at the same visits GH concentration was assessed.|Baseline and the end of the core treatment period (up to 7 months)|Modified intent-to-treat population: All enrolled participants who received any amount of study drug and who had at least 1 IGF-1 or GH assessment after the first dose of octreotide.||Percentage of participants|||Number
693637|NCT01412424|Primary|Percentage of Responders at the End of the Extension Treatment Period|A responder was defined as a participant with a serum insulin-like growth factor-1 (IGF-1) concentration < 1.3 times the upper limit of normal (adjusted for age and gender) and a growth hormone (GH) concentration < 2.5 ng/mL. The growth hormone concentration was the mean of 5 fasted GH serum concentrations collected at 30 minute intervals for 2 hours, 2 to 4 hours post-octreotide dose. IGF-1 concentration was determined in serum samples taken at the same visits GH concentration was assessed.|End of the extension treatment period (up to 13 months)|Extension intent-to-treat population: All participants who entered the extension treatment period and received any amount of study drug during the extension treatment period.||Percentage of responders||95% Confidence Interval|Number
693638|NCT01412424|Primary|Percentage of Responders at the End of the Core Treatment Period|A responder was defined as a participant with a serum insulin-like growth factor-1 (IGF-1) concentration < 1.3 times the upper limit of normal (adjusted for age and gender) and a growth hormone (GH) concentration < 2.5 ng/mL. The growth hormone concentration was the mean of 5 fasted GH serum concentrations collected at 30 minute intervals for 2 hours, 2 to 4 hours post-octreotide dose. IGF-1 concentration was determined in serum samples taken at the same visits GH concentration was assessed.|End of the core treatment period (up to 7 months)|Modified intent-to-treat population: All enrolled participants who received any amount of study drug and who had at least 1 IGF-1 or GH assessment after the first dose of octreotide.||Percentage of responders||95% Confidence Interval|Number
693639|NCT01412333|Secondary|Number of Participants With Anti-Drug Antibodies (ADAs) to Ocrelizumab|Number of participants positive for anti-drug antibodies (ADAs) to ocrelizumab is the number of post- baseline evaluable participants determined to have treatment-induced ADA or treatment-enhanced ADA during the study period.|Baseline up to Week 96|Baseline evaluable participants with an ADA assay result from a baseline sample(s). The safety population included all participants who received any study drug. Here, n signifies the number of participants evaluable at the specified time points.||participants|||Number
693640|NCT01412333|Secondary|Exposure to Ocrelizumab (Area Under the Concentration - Time Curve, AUC)|AUC represents total drug exposure for one dosing interval after the 4th dose.|Pre-infusion at Weeks 1, 24, 48, 72; and 30 minutes post-infusion at Week 72; at any time during Weeks 84 and 96|The pharmacokinetics (PK) population included all participants in the ocrelizumab group who had at least 1 measurable concentration value.||micrograms per milliter*day||Standard Deviation|Mean
693947|NCT01409213|Primary|Change From Baseline for Mean Fasting Blood Glucose (FBG)|Change from baseline was defined as mean FBG baseline value minus mean FBG end of observation value.|Baseline and end of Observation (up to Month 6)|Participants from the full analysis set with available data.||mg/dL||Standard Deviation|Mean
693642|NCT01412333|Secondary|Percentage of Participants Who Have No Evidence of Disease Activity (NEDA) up to Week 96|NEDA was defined only for participants with a baseline EDSS score >=2.0. The EDSS scale ranges from 0 (normal neurological exam) to 10 (death due to multiple sclerosis). Participants who completed the 96- week treatment period were considered as having evidence of disease activity if at least one protocol- defined relapse (PDR), a confirmed disability progression (CDP) event or at least one MRI scan showing MRI activity (defined as Gd-enhancing T1 lesions, or new or enlarging T2 lesions) was reported during the 96-week treatment period, otherwise the participant was considered as having NEDA.|Week 96|ITT population included all randomized participants in the study. Here, number of participants analysed signifies number of participants who were evaluable for this outcome measure.||percentage of participants||95% Confidence Interval|Number
693643|NCT01412333|Secondary|Change From Baseline in Short Form Health Survey-36 (SF-36) Physical Component Summary (PCS) Score at Week 96|The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and mental composite t-score (MCS). The range for all 8 domains as well as for the composite t- scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.|Baseline, Week 96|Descriptive statistics at baseline include participants with assessment at baseline and at least one post- baseline value. ITT population included all randomized participants in the study. Here, n signifies the number of participants evaluable at specified time points.||t-score||Standard Error|Mean
693644|NCT01412333|Secondary|Percent Change in Brain Volume as Detected by Brain Magnetic Resonance Imaging (MRI) From Week 24 to Week 96|Brain volume was recorded as an absolute “normalized” value at the baseline visit then recorded at subsequent visits as a percentage change relative to the absolute value at the baseline visit. Therefore, brain volume at Week 24 was calculated as the brain volume at the baseline visit multiplied by 1 + ([percentage change in brain volume from baseline visit to Week 24]/100). Estimates are from analysis based on mixed-effect model of repeated measures (MMRM) using unstructured covariance matrix: Percentage Change = Brain Volume at Week 24 + Geographical Region (US vs. ROW) + Baseline EDSS (< 4.0 vs. >= 4.0) + Week + Treatment + Treatment*Week (repeated values over Week) + Brain Volume at Week 24*Week. The EDSS scale ranges from 0 (normal neurological exam) to 10 (death due to multiple sclerosis).|From week 24 up to week 96|ITT population included all randomized participants in the study. Here, number of participants analyzed signifies number of participants who were evaluable for this outcome measure.||percent change||Standard Error|Mean
693645|NCT01412333|Secondary|Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Score to Week 96|MSFC score consists of: A) Timed 25-Foot walk; B) 9-Hole Peg Test (9-HPT); and C) Paced Auditory Serial Addition Test (PASAT-3 version). The MSFCS is based on the concept that scores for these three dimensions (arm, leg, and cognitive function) are combined to create a single score (the MSFC) that can be used to detect change over time in a group of participants with MS. Since the three primary measures differ in what they actually measure, a common composite score for the three different measures i.e., Z- score was selected for the purpose. MSFC Score = {Z arm, average + Z leg, average + Z cognitive} / 3.0. The results from each of these three tests are transformed into Z-scores and averaged to yield a composite score for each participant at each time point. A score of +1 indicates that, on average, an individual scored 1 standard deviation (SD) better than the reference population and a score of -1 indicates that an individual scored 1 SD worse than the reference population.|Baseline, Week 96|ITT population included all randomized participants in the study. Here, n signifies the number of participants evaluable at specified time points.||Z-score||Standard Error|Mean
693646|NCT01412333|Secondary|Number of T1 Hypointense Lesions During the Double-Blind Treatment|The total number of new T1-Hypo-Intense Lesions (Chronic Black Holes) for all participants in the treatment group was calculated as the sum of the individual number of new lesions at Weeks 24, 48, and 96.|Baseline up to week 96|ITT population included all randomized participants in the study.||lesions|||Number
693647|NCT01412333|Secondary|Time to Onset of Confirmed Disability Progression (CDP) for at Least 24 Weeks During the Double-Blind Treatment Period|Disability progression was defined as an increase in the Expanded Disability Status Scale (EDSS) score of: A) >=1.0 point from the baseline EDSS score when the baseline score was less than or equal to (<=) 5.5 B) >=0.5 point from the baseline EDSS score when the baseline score was >5.5 The EDSS scale ranges from 0 (normal neurological exam) to 10 (death due to multiple sclerosis). This outcome measure was considered confirmatory only when results of both studies WA21092 and WA21093 were combined. Disability progression was considered confirmed when the increase in the EDSS was confirmed at a regularly scheduled visit at least 24 weeks after the initial documentation of neurological worsening. Participants who had initial disability progression with no confirmatory EDSS assessment and who were on treatment at time of clinical cut-off date were censored at the date of their last EDSS assessment.|Week 104|ITT population included all randomized participants in the study.||weeks||Full Range|Median
693648|NCT01412333|Secondary|Percentage of Participants With Confirmed Disability Improvement (CDI) for at Least 12 Weeks|Disability improvement was assessed only for the subgroup of participants with a baseline EDSS score of >= 2.0. It was defined as a reduction in EDSS score of: A) >=1.0 from the baseline EDSS score when the baseline score was >=2 and <=5.5 B) >= 0.5 when the baseline EDSS score > 5.5. The EDSS scale ranges from 0 (normal neurological exam) to 10 (death due to multiple sclerosis). This outcome measure was considered confirmatory only when results of both studies WA21092 and WA21093 were combined.|Week 96|ITT population included all randomized participants in the study. Here, number of participants analyzed signifies number of participants who were evaluable for this outcome measure.||percentage of participants||95% Confidence Interval|Number
693649|NCT01412333|Secondary|Number of New, and/or Enlarging T2 Hyperintense Lesions as Detected by Brain Magnetic Resonance Imaging (MRI) During the Double Blind Treatment|The total number of new and/or enlarging T2 lesions for all participants in the treatment group was calculated as the sum of the individual number of lesions at Weeks 24, 48, and 96.|Baseline up to week 96|ITT population included all randomized participants in the study.||lesions|||Number
694561|NCT01400412|Secondary|Change in CD4 Count From Baseline to Week 48|Change in CD4 count from baseline (week 0) to week 48|Week 0, week 48|Change in total CD4 count is analyzed in the same as-treated population as in the primary as-treated analysis.||cells/mm^3||Inter-Quartile Range|Median
693651|NCT01412333|Secondary|Time to Onset of Confirmed Disability Progression (CDP) for at Least 12 Weeks During the Double-Blind Treatment Period|Disability progression was defined as an increase in the Expanded Disability Status Scale (EDSS) score of: A) >=1.0 point from the baseline EDSS score when the baseline score was less than or equal to (<=) 5.5 B) >=0.5 point from the baseline EDSS score when the baseline score was >5.5 The EDSS scale ranges from 0 (normal neurological exam) to 10 (death due to multiple sclerosis). This outcome measure was considered confirmatory only when results of both studies WA21092 and WA21093 were combined. Disability progression was considered confirmed when the increase in the EDSS was confirmed at a regularly scheduled visit at least 12 weeks after the initial documentation of neurological worsening. Participants who had initial disability progression with no confirmatory EDSS assessment and who were on treatment at time of clinical cut-off date were censored at the date of their last EDSS assessment.|Week 104|ITT population included all randomized participants in the study.||weeks||Full Range|Median
693652|NCT01412333|Primary|Annualized Relapse Rate (ARR) in Participants With Relapsing Multiple Sclerosis (MS) at 96 Weeks|ARR was protocol-defined and calculated as the total number of relapses for all participants in the treatment group divided by the total participant-years of exposure to that treatment.|Week 96|Intent-to-treat (ITT) population included all randomized participants in the study.||relapses/participant year of treatment||95% Confidence Interval|Number
693653|NCT01412281|Secondary|Number of Participants With Local and Systemic Adverse Events, as a Measure of Safety and Tolerability|"Solicited local and systemic AEs, Unsolicited AEs, Tolerability and acceptability
Unsolicited AEs were collected from baseline (Day 1) to 3 weeks after vaccination (Day 22 ± 2 days).
Solicited local and systemic AEs were collected by subjects diary from Day 1 (day of vaccination) to Day 4"|Baseline (Day 1) and 3 weeks after vaccination (Day 22 ± 2 days)|Safety population, all vaccinated subjects||participants|||Number
693654|NCT01412281|Primary|Seroconversion|"Seroconversion rate, defined as proportion of subjects with ≥4-fold increase in HI antibody titer and with a titer of ≥1:40 (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA Note for guidance on harmonisation of requirements for influenza vaccines, 1997)"|3 weeks after vaccination (Day 22 ± 2 days)|Intent-to-treat population, vaccinated subjects with available pre- and post-vaccination titers||percentage of seroconverted subjects||95% Confidence Interval|Number
693655|NCT01412281|Primary|Seroprotection|"Seroprotection rate, defined as proportion of subjects with HI antibody titer ≥1:40 (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA Note for guidance on harmonisation of requirements for influenza vaccines, 1997)"|3 weeks after vaccination (Day 22 ± 2 days)|Intent-to-treat, vaccinated subjects with available pre- and post-vaccination titers||percentage of seroprotected subjects||95% Confidence Interval|Number
693656|NCT01412281|Primary|Geometric Mean Titer|"GMT of HI antibodies and fold-increase in GMT (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA Note for guidance on harmonisation of requirements for influenza vaccines, 1997)"|3 weeks after vaccination (Day 22 ± 2 days)|Intent-to-treat, vaccinated subjects with available pre- and post-vaccination titers||GMT fold increase from baseline||95% Confidence Interval|Number
693657|NCT01412229|Secondary|Quality of Life|Functional Assessment of Cancer Therapy - Head & Neck (FACT-HN) is the FACT-G and a 12 item head and neck cancer specific subscale completed at screening (Screening), 3 weeks post induction chemotherapy (Treatment Break), 7 weeks post concomitant chemoradiotherapy (7 weeks Off Treatment), one year post off-treatment (1 year Off Treatment). The FACT-G is a 27 item measure of general QOL assessing function in 4 domains: physical well-being (PWB), social-family well-being (SFWB), emotional well-being (EWB) and functional well-being (FWB). Items are rated by patients on a Likert scale from 0 to 4 (resulting in potential total scores between 0 and 156). Higher scores represent better QOL.|screening until one year after treatment|All patients on treatment who returned completed questionnaires at each time point||FACT-HN score||Full Range|Median
693658|NCT01412229|Secondary|Number of Participants With at Least One Grade 3-4 Toxicity, Listed by Event|Toxicity will be assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.|24 Weeks|Patients who received study treatment||participants|||Number
693659|NCT01412229|Secondary|Number of Participants With at Least One Grade 3-4 Toxicity|Toxicity will be assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.|9 Weeks|Patients who received treatment on study||Participants|||Count of Participants
693660|NCT01412229|Secondary|Overall Survival|Rate of Overall Survival|1 year|Patients who completed treatment||Participants|||Count of Participants
693661|NCT01412229|Secondary|Complete Response Rate (CR)|Complete Response Rate as defined by RECIST 1.1 after induction chemotherapy followed by definitive chemoradiation|20 weeks|Patients who completed treatment||Participants|||Count of Participants
693662|NCT01412229|Secondary|Objective Response Rate (CR+PR)|Objective Response Rate as defined by RECIST 1.1 after induction chemotherapy followed by definitive chemoradiation. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.|20 weeks|Patients who completed treatment||Participants|||Count of Participants
693663|NCT01412229|Secondary|Progression Free Survival|Rate of Progression Free Survival (Time to death or progression defined by imaging of target lesions via CT or MRI scan post induction chemotherapy and chemoradiotherapy every 3 months for one year)|1 year|||percentage of participants||95% Confidence Interval|Number
693664|NCT01412229|Secondary|Rate of Complete Response Following Induction Chemotherapy|Report the rate of complete responses, defined as disappearance of all target lesions, following induction chemotherapy. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions.|Baseline evaluation to 3 weeks after induction chemotherapy|||Participants|||Count of Participants
693785|NCT01410357|Other Pre-specified|Comparison of Utilization (Phys Ed) Score Between TTIM and TAU at 60 Weeks|The Utilization of Physical Education score looks at how many times a participant used these resources. Analyses include a simple mean and SD.|60 weeks|While 74 participants completed the TTIM arm and 76 completed TAU, there was some missing data for this scale, resulting in 74 TTIM and 75 TAU.||times utilized||Standard Deviation|Mean
693665|NCT01412229|Primary|Clinical Response Rate Following Induction Chemotherapy|Evaluation of target lesions via imaging with CT or MRI scans at 2-3 weeks post induction chemotherapy. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.|9 weeks|||Participants|||Count of Participants
693666|NCT01412164|Secondary|Stent Implantation Success Rate|30 days, 6 months, and 2-5 years TLF, cardiovascular composite endpoints, ARC defined stent thrombosis|5 years||||||
693667|NCT01412164|Primary|Device Related Cardiovascular Composite Endpoint|Device-related cardiovascular composite endpoint, including cardiac death, target vessel MI and clinically driven TLR at 12 months post procedure|12 months|||participants|||Number
693668|NCT01412151|Secondary|Biological Markers of Disease Progression|Biological indicators that creatine treatment might affect the progression of HD: serum creatine levels, neuroimaging, metabolomic and gene expression analysis|310 Weeks||||||
693669|NCT01412151|Secondary|Clinical Measures|Components of the UHDRS (Unified Huntington Disease Rating Scale)|310 Weeks||||||
693670|NCT01412151|Primary|Tolerability|Proportion of subjects able to complete treatment|306 Weeks|||Participants|||Number
693671|NCT01412086|Primary|Intra-rater Reliability of Physician Raters Using the Global Eyebrow Assessment (GEBA) Scale|Intra-rater (within raters) agreement of the GEBA scores (1=very sparse, 2=sparse, 3=full, 4=very full) to assess eyebrow fullness was evaluated by weighted Kappa statistics. Weighted Kappa statistics were calculated for each of 7 raters who evaluated 112 subjects using GEBA scale, assessing agreement between 2 different time points at day 1. The overall intra-rater agreement for Kappa statistics for all raters combined was estimated by pooling Kappa statistics for each rater using a chi-square statistic. The degree of agreement of the point estimates of Kappa statistics was interpreted according to the reference range scale that was predefined as: ≤ 0: poor, 0.00-0.20: slightly, 0.21-0.40: fair, 0.41-0.60: moderate, 0.61-0.80: substantial and 0.81-1:00: almost perfect. The 95% confidence interval for Kappa statistics was provided.|Day 1|All enrolled participants.||Kappa statistics||95% Confidence Interval|Number
693672|NCT01412086|Primary|Inter-rater Reliability of Physician Raters Using the Global Eyebrow Assessment (GEBA) Scale|Inter-rater agreement (among raters) of the GEBA scores (1=very sparse, 2=sparse, 3=full, 4=very full) to assess eyebrow fullness was evaluated using Kendall’s coefficient of concordance (Kendall’s W). Each of 7 raters scored 112 subjects’ eyebrows using the GEBA Scale at 2 different time points at day 1. The overall inter-rater agreement for Kendall’s W for all raters combined was estimated based on the average of the scores from those 2 different time points. The degree of agreement of the point estimates of Kendall’s W was interpreted according to the reference range scale that was pre-defined as: ≤ 0: poor, 0.00-0.20: slightly, 0.21-0.40: fair, 0.41-0.60: moderate, 0.61-0.80: substantial and 0.81-1:00: almost perfect. The 95% confidence interval for Kendall’s W was provided.|Day 1|||Kendall's W||95% Confidence Interval|Number
693673|NCT01411891|Primary|Femoral Nerve Catheter Bacterial Colonization|Describes rate of femoral nerve catheter bacterial colonization.|Colonization measured following catheter removal (approximately 48 hours after placement).|Patients presenting for elective TKA.||participants|||Number
693674|NCT01411891|Secondary|Catheter Insertion Site Colonization.|Skin at the FNC insertion site will be swabbed with a sterile cotton tip applicator moistened with sterile normal saline. The swab will be placed in a sterile container. The swab will be inoculated onto a blood agar plate/eosin-methylene blue plate/chocolate agar plate and incubated for 3 days aerobically, then inoculated onto an anaerobic brucella-agar plate and incubated for 7 days anaerobically. Bacterial growth found in the first quadrant of the inoculated plate will be defined as low grade, in the second and/or third will be moderate, and in the fourth quadrant will be heavy.|24-48 hours.||||||
693675|NCT01411891|Primary|Catheter Tip Colonization|Three cm of the for research purposes only, a 3 cm distal portion will be cut using sterile scissors into a sterile container, and sent to the lab for culture in a sterile container. The catheter segments will be rolled onto blood agar plates at 35°C under aerobic and anaerobic conditions. Number of colonies will be counted at 1 week. The peripheral nerve catheter tip will be considered colonized if the culture yields 15 or greater colony forming units.|24-48 hours after placement of femoral nerve catheter.||||||
693800|NCT01410357|Primary|Global Assessment of Functioning (GAF) at 60 Weeks|The GAF is a 100-point single-item scale that measures global functioning. Possible scores range from 1 to 100, with higher scores indicating better functioning.|60 weeks|||scores on a scale||Standard Deviation|Mean
693695|NCT01411696|Secondary|Change From Baseline in Central Retinal Thickness by Optical Coherence Tomography (OCT) 4 to 20 Weeks After Each Injection|Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed in the study eye after pupil dilation at baseline and 4 to 20 weeks after each injection. A negative change from baseline indicates improvement.|Baseline, 4 to 20 Weeks after Each injection (up to 6 months)|All participants with data available for analysis.||Micron (μm)||Standard Deviation|Mean
693696|NCT01411696|Secondary|Percentage of Participants With an Increase of 3 Lines or More in BCVA|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). An increase of 3 or more lines read correctly compared to baseline is an improvement.|Baseline, Up to 6 months|All participants.||Percentage of participants|||Number
693697|NCT01411696|Secondary|Percentage of Participants With an Increase of 2 Lines or More in BCVA|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). An increase of 2 or more lines read correctly compared to baseline is an improvement.|Baseline, Up to 6 months|All participants.||Percentage of participants|||Number
693698|NCT01411696|Primary|Change From Baseline in Best Corrected Visual Acuity (BCVA) 4 to 20 Weeks Following the Last OZURDEX® (Dexamethasone Intravitreal Implant) Injection|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). The change in BCVA was calculated using the most improved number of lines read correctly between 4 and 20 weeks following the last injection of OZURDEX® - the number of lines read correctly at baseline. A positive change from baseline indicates improvement.|Baseline, 4 to 20 weeks after last injection (Up to 6 months)|All participants with data available for analysis.||Lines||Full Range|Mean
693699|NCT01411592|Secondary|Debonding of the RBFDP|Restoration was rebonded without any impairment of function|5 years|||participants|||Number
693700|NCT01411592|Primary|Final Loss of the Restauration||5 years|||participants|||Number
693701|NCT01411501|Secondary|Change From Baseline in Difficulty Degree of Defecation at the 8th Week|"This outcome describes how much effort the patients with while defecating. It ranges from 0 to 3.
0—Without difficulty
Defecation straining
Severe defecation straining
Defecation with the help of hands, A 0 is considered better than 3 for outcome. Patients score for themselves according to their own feelings.
[the average score of one week at the 8th week]-[the average score of one week at baseline]"|baseline and at 8 weeks|||participants|||Number
693702|NCT01411501|Secondary|Change From Baseline in the Bristol Stool Scale at the 8th Week|Bristol stool scale provides illustration of seven stool types. It ranges from 1 to 7 with the meaning that 1 referring to separate hard lumps and 7 referring to watery, no solid pieces. For patients with constipation, a higher score means a better outcome. This outcome means the Bristol Stool Scale at the 8th week-the Bristol Stool Scale at baseline.|baseline and at 8 weeks|||units on a scale||Full Range|Mean
693703|NCT01411501|Secondary|Changes of the SBMs From Baseline at Week 8|[average number of spontaneous bowel movements in a week at week 8]-[average number of spontaneous bowel movements in a week at baseline]|baseline and at 8 weeks|||times per week||95% Confidence Interval|Mean
693704|NCT01411501|Secondary|Change From Baseline in Difficulty Degree of Defecation at the 4th Week|"This outcome describes how much effort the patients with while defecating.It ranges from 0 to 3.
0—Without difficulty
Defecation straining
Severe defecation straining
Defecation with the help of hands, A 0 is considered better than 3 for outcome. Patients score for themselves according to their own feelings.
[the average score of one week at the 4th week]-[the average score of one week at baseline]"|baseline and at 4 weeks|||participants|||Number
693705|NCT01411501|Secondary|Change From Baseline in the Bristol Stool Scale at the 4th Week|Bristol stool scale provides illustration of seven stool types. It ranges from 1 to 7 with the meaning that 1 referring to separate hard lumps and 7 referring to watery, no solid pieces. For patients with constipation, a higher score means a better outcome. This outcome means the Bristol Stool Scale at the 4th week-the Bristol Stool Scale at baseline.|baseline and at 4 weeks|||units on a scale||95% Confidence Interval|Mean
693706|NCT01411501|Primary|Change of the SBMs From Baseline at Week 4|[average number of spontaneous bowel movements in a week at week 4]-[average number of spontaneous bowel movements in a week at baseline]|baseline and at 4 weeks|||times per week||95% Confidence Interval|Mean
693707|NCT01411488|Primary|Number of Patients With Anal Erosion Within 14 Days After Insertion of FMS|anal erosion within 14 days after insertion of FMS|up to 14 days|Pearson's chi square test (categorical data) and Wilcoxon test (continuous measures). Logistic regression was used to assess primary endpoint by time the device was in use.||Participants|||Count of Participants
693708|NCT01411228|Secondary|Liver Volume|Liver volume by MRI or Ultrasound. Baseline is the value obtained from the parent study: PB-06-005 for 30 and 60 Units/kg arms and PB-06-002 from Switchover arm.|Baseline, months 12 and 24|Two Switchover Patients completed 18 months treatment due to early closure of the study site and continued in a compassionate use program||Milliliters||Standard Error|Mean
693709|NCT01411228|Secondary|Platelet Count|Platelet count. Baseline is the value obtained from the parent study: PB-06-005 for 30 and 60 Units/kg arms and PB-06-002 from Switchover arm.|Baseline, months 9, 12, 24 and 33-36|Two Switchover Patients completed 18 months treatment due to early closure of the study site and continued in a compassionate use program||Platelets/mm^3||Standard Error|Mean
693710|NCT01411228|Secondary|Spleen Volume|Spleen volume measured by MRI (or ultrasound). Baseline is the value obtained from the parent study: PB-06-005 for 30 and 60 Units/kg arms and PB-06-002 from Switchover arm.|Baseline, months 12 and 24|Two Switchover Patients completed 18 months treatment due to early closure of the study site and continued in a compassionate use program||Milliliters||Standard Error|Mean
693711|NCT01411228|Secondary|Chitotriosidase|Chitotriosidase. Baseline is the value obtained from the parent study: PB-06-005 for 30 and 60 Units/kg arms and PB-06-002 from Switchover arm.|Baseline, months 9, 12 and 24|Chitotriosidase was not analyzed for the subjects in the Switchover group||nmol/mL*h||Standard Deviation|Mean
693712|NCT01411228|Primary|Hemoglobin|Median and interquartile range. Baseline is the value obtained from the parent study: PB-06-005 for 30 and 60 Units/kg arms and PB-06-002 from Switchover arm.|Baseline, months 9, 12 and 24|Two Switchover Patients completed 18 months treatment due to early closure of the study site and continued in a compassionate use program||g/dL||Inter-Quartile Range|Median
693713|NCT01411215|Secondary|Number of RA Participants Had Remission of Disease|Counts of participants had remission of disease. Remission of disease was defined by a DAS28-4 (ESR) <2.6.|Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 36, Week 52|All enrolled participants who received at least 1 dose of etanercept. Participants analyzed were participants who were evaluated for DAS28-4 (ESR). n=number of evaluable participants at the corresponding visit.||Participants|||Number
693714|NCT01411215|Secondary|Number of RA Participants Had DAS28-4 (ESR) Improvement|Counts of participants had good, moderate and no response to treatment with etanercept. Good response was present DAS28-4 (ESR) <=3.2, DAS28-4 (ESR) improvement from baseline >1.2. Moderate response was 1) present DAS28-4 (ESR) >3.2 and <=5.1, DAS28-4 (ESR) improvement from baseline >1.2, or >0.6 and <=1.2; 2) present DAS28-4 (ESR) <=3.2, DAS28-4 (ESR) improvement from baseline >0.6 and <=1.2; or 3) present DAS28-4 (ESR) >5.1, DAS28-4 (ESR) improvement from baseline > 1.2. No response was 1) DAS28-4 (ESR) improvement from baseline <=0.6 regardless present DAS28-4 (ESR), or 2) present DAS28-4 (ESR) >5.1, DAS28-4 (ESR) improvement from baseline >0.6 and <=1.2.|Week 2, Week 4, Week 8, Week 12, Week 36, Week 52|All enrolled participants who received at least 1 dose of etanercept. Participants analyzed were participants who were evaluated for DAS28-4 (ESR) improvement. n=number of evaluable participants at the corresponding visit.||Participants|||Number
693715|NCT01411215|Secondary|Disease Activity Score (DAS) Based on 28-joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])|DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity on a 0-100 mm VAS: DAS28-4 (ESR)=0.56*square root(TJC 28 joints) + 0.28*square root(SJC 28 joints) + 0.70*ln(ESR) + 0.014*PtGA. DAS28-4 (ESR) above 5.1 indicated high disease activity whereas a DAS28-4 (ESR) below 3.2 indicated low disease activity.|Baseline (Week 0), Week 2, Week 4, Week 12, Week 52|All enrolled participants who received at least 1 dose of etanercept. Participants analyzed were RA participants who were evaluated for DAS28-4 (ESR). n=number of evaluable participants at the corresponding visit.||units on a scale||Standard Deviation|Mean
693716|NCT01411215|Secondary|Swollen Joint Count (SJC) for RA Participants|SJC (28 joints) include the joints of shoulders, elbows, wrists, MCP, PIP, and the knees. The joints were assessed for swelling using the following scale: Present (1), Absent (2), Not Done (3), Not Applicable (4). Artificial joints were not assessed.|Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52|All enrolled participants who received at least 1 dose of etanercept. Participants analyzed were RA participants who were evaluated for SJC. n=number of evaluable participants at the corresponding visit.||Joints||Standard Deviation|Mean
693717|NCT01411215|Secondary|Tender Joint Count (TJC) for RA Participants|TJC (28 joints) include the joints of shoulders, elbows, wrists, metacarpophalangeal (MCP), proximal interphalangeal (PIP), and the knees. The joints were assessed for tenderness using the following scale: Present (1), Absent (2), Not Done (3), Not Applicable (4). Artificial joints were not assessed.|Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52|All enrolled participants who received at least 1 dose of etanercept. Participants analyzed were RA participants who were evaluated for TJC. n=number of evaluable participants at the corresponding visit.||Joints||Standard Deviation|Mean
693718|NCT01411215|Secondary|Number of Participants With Any Abnormal Laboratory Test Results|Number of participants with any abnormal laboratory test results, criteria for abnormalities were complete blood count (CBC) including hemoglobin (<0.8*lower limit of normal[LLN]), mean corpuscular volume (MCV, <0.9*LLN or >1.1*upper limit of normal[ULN]), hematocrit (<0.8*LLN), red blood cell count (<0.8*LLN), platelets (<0.5*LLN or >1.75*ULN), white blood cell count (<0.6*LLN or >1.5*ULN), lymphocytes (<0.8*LLN or >1.2*ULN), neutrophils (<0.8*LLN or >1.2*ULN), basophil (>1.2*ULN), eosinophil (>1.2*ULN), and monocytes (>1.2*ULN); ESR (>1.5*ULN); aspartate aminotransferase (AST,>3.0*ULN); alanine aminotransferase (ALT,>3.0*ULN); blood urea nitrogen (BUN,>1.3*ULN); and creatinine (CRE,>1.3*ULN).|Baseline (Week 0) up to Week 52|All enrolled participants who received at least 1 dose of etanercept. Participants analyzed were participants who were evaluated for laboratory test abnormalities.||Participants|||Number
693719|NCT01411215|Secondary|Evaluate the Association Between Participant's Age and Treatment Adherence Rate|Participants were allocated to 5 groups by age as 10 years separately: <20 years, >=20 and <30 years, >=30 and <40 years, >=40 and <50 years, >50 years. The number of participants with treatment adherence rate 1), <50%, 2), >=50% and <70%, 3), >=70% and <80%, 4), >=80% and <100%, 5), >=100% and <120%, and 6), >=120% were provided for each age group described above.|First day of receiving etanercept up to Week 52|All enrolled participants who received at least 1 dose of etanercept. Participants analyzed were participants who were evaluated for treatment adherence rate; those participants with partial dosing dates were excluded. n=number of evaluable participants at the corresponding age group.||Participants|||Number
693720|NCT01411215|Secondary|Number of Participants With Treatment Adherence Rate of 1), <50 Percents (%), 2), >=50% and <70%, 3), >=70% and <80%, 4), >=80% and <100%, 5), >=100% and <120%, and 6), >=120%|Treatment adherence rate was calculated using the following formula: [Actual dosing/expected dosing on the basis of approved product label] × 100%. Counts of participants by 6 levels of treatment adherence rate: 1), <50%, 2), >=50% and <70%, 3), >=70% and <80%, 4), >=80% and <100%, 5), >=100% and <120%, and 6), >=120%.|First day of receiving etanercept up to Week 52|All enrolled participants who received at least 1 dose of etanercept. Participants analyzed were participants who were evaluated for treatment adherence rate; those participants with partial dosing dates were excluded.||Participants|||Number
693721|NCT01411215|Secondary|VAS Score for Pain|Participants placed a mark on a 0-100 mm VAS to indicate the magnitude of pain, with 0 meaning no pain and 100 meaning the most severe pain.|Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52|All enrolled participants who received at least 1 dose of etanercept. Participants analyzed were participants who were evaluated for pain. n=number of evaluable participants at the corresponding visit.||mm||Standard Deviation|Mean
693722|NCT01411215|Secondary|Participant’s Global Assessment (PtGA) of Disease Activity|Participants placed a vertical line on a 0-100 mm VAS to indicate the magnitude of their global disease activity, with 0 meaning no disease activity (disease inactive) and 100 meaning extreme disease activity (disease extremely active).|Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52|All enrolled participants who received at least 1 dose of etanercept. Participants analyzed were participants who were evaluated for PtGA of disease activity. n=number of evaluable participants at the corresponding visit.||mm||Standard Deviation|Mean
693723|NCT01411215|Secondary|Physician’s Global Assessment of Disease Activity|Physicians indicated on a 0-100 millimeters (mm) visual analogue scale (VAS) to assess the activity of the participant’s disease according to the participant’s clinical condition, with 0 meaning no disease activity (disease inactive) and 100 meaning extreme disease activity (disease extremely active).|Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52|All enrolled participants who received at least 1 dose of etanercept. Participants analyzed were participants who were evaluated for physician’s global assessment of disease activity. n=number of evaluable participants at the corresponding visit.||mm||Standard Deviation|Mean
693724|NCT01411215|Primary|Number of Participants With AEs Per System Organ Class During 52 Weeks|An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Participants with multiple AEs within a category (system organ class) were counted once within the category.|First day of receiving etanercept through 52 weeks|All enrolled participants who received at least 1 dose of etanercept.||Participants|||Number
693725|NCT01411215|Primary|Number of Participants With AEs Per System Organ Class During 24 Weeks|An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Participants with multiple AEs within a category (system organ class) were counted once within the category.|First day of receiving etanercept through 24 weeks|All enrolled participants who received at least 1 dose of etanercept.||Participants|||Number
693726|NCT01411215|Primary|Number of Participants Who Had Any SAEs During 52 Weeks|An SAE was defined as an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Informed consent or signed data privacy statement through 52 weeks|All enrolled participants who received at least 1 dose of etanercept.||Participants|||Number
693727|NCT01411215|Primary|Number of Participants Who Had Any Serious Adverse Events (SAEs) During 24 Weeks|An SAE was defined as an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Informed consent or signed data privacy statement through 24 weeks|All enrolled participants who received at least 1 dose of etanercept.||Participants|||Number
693728|NCT01411215|Primary|Number of Participants Who Had Any AEs During 52 Weeks|An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|First day of receiving etanercept through 52 weeks|All enrolled participants who received at least 1 dose of etanercept.||Participants|||Number
693729|NCT01411215|Primary|Number of Participants Who Had Any Adverse Events (AEs) During 24 Weeks|An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|First day of receiving etanercept through 24 weeks|All enrolled participants who received at least 1 dose of etanercept.||Participants|||Number
693730|NCT01411137|Primary|Parkinson’s Disease Questionnaire-8 (PDQ-8)|Change from Baseline in Parkinson's disease Questionnaire-8 (PDQ-8) at End of Study or early discontinuation. The PDQ-8 is a self-reported questionnaire consisting of 8 questions regarding the subject's disease symptoms, each item ranging from 0 to 4, and the responses consist of 0=Never, 1=Occasionally, 2=Sometimes, 3=Often, and 4=Always or cannot do at all, total score ranging from 0 (never have problems/issues) to 32 (always have problems or cannot do at all).|6 months|||units on a scale||Standard Deviation|Mean
693731|NCT01411137|Primary|Clinical Global Impression (CGI)|"Clinician-reported satisfaction outcome of IPX066 using Clinical Global Impression (PGI) 7-point scale.
At Part 1 Week 6; Part 2 Month 3, and Month 6 or at Early Termination, the Investigator rated how much a subject’s overall condition had changed since Part 1 Visit 1 (Baseline) using 7-point scale. 1=very much worse and 7=very much improved."|6 months|||units on a scale||Standard Deviation|Mean
693732|NCT01411137|Primary|Patient Global Impression (PGI)|At Part 1 Week 6, Part 2 Month 3 and Month 6 or at Early Termination, the subjects rated the change in their condition with IPX066 treatment from their condition prior to Part 1 Visit 1(Baseline) using Patient Global Impression (PGI) 7-point scale. 1=very much worse and 7=very much improved.|6 months|||units on a scale||Standard Deviation|Mean
693733|NCT01410773|Secondary|Number of Alternative Site (AST) Palm Blood Glucose (BG) Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method|Untrained subjects with diabetes self-test subject Alternative Site (AST) Palm blood using an investigational Blood Glucose Monitoring System (BGMS). BGM meter results are compared with capillary plasma BG results obtained with a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG meter results are used to calculate the number of BG results within +/- 15mg/dL (for reference BG results <75mg/dL) or +/- 20% (for reference BG results >=75mg/dL) of the YSI capillary plasma reference method results.|1 hour|One subject had low blood sugar. The protocol (and User Guide) do not allow alternative site testing when blood sugar is low. The remaining 109 subjects tested one strip lot on the BGM system. 109 test results were available.||participants|||Number
693734|NCT01410773|Primary|Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/-15mg/dL(<75 mg/dL) or Within +/- 20% (>=75 mg/dL) of Laboratory Glucose Method|Untrained subjects with diabetes self-test fingerstick blood using an investigational Blood Glucose Meter (BGM). BGM results are compared with capillary plasma BG results obtained with a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG meter results are used to calculate the number of BG results within +/- 15mg/dL (for reference BG results <75mg/dL) or within +/- 20%(for reference BG results >=75mg/dL) of the reference method results (YSI capillary plasma).|1 hour|110 subjects tested one of 3 test strip lots on the BGM system. 110 (1x110) test results are available.||participants|||Number
693735|NCT01410604|Secondary|Waist Circumference|Change from baseline in Waist circumference after 3 months of treatment.|baseline and 3 months|||cm||Standard Deviation|Mean
693736|NCT01410604|Secondary|Body Mass Index|Change from baseline in Body Mass Index after 3 months of treatment.|baseline and 3 months|||kg/m^2||Standard Deviation|Mean
693737|NCT01410604|Secondary|Fasting Insulin|Change from baseline in Fasting insulin after 3 months of treatment.|baseline and 3 months|||µU/mL||Standard Deviation|Mean
693738|NCT01410604|Secondary|Fasting Plasma Glucose|Change from baseline in Fasting plasma glucose after 3 months of treatment.|baseline and 3 months|||mg/dL||Standard Deviation|Mean
693739|NCT01410604|Primary|Tumour Necrosis Factor Alpha|Change from baseline in Tumour necrosis factor alpha after 3 months of treatment.|baseline and 3 months|||pg/mL||Standard Deviation|Mean
693740|NCT01410604|Primary|Interleukin 6|Change from baseline in Interleukin 6 after 3 months of treatment.|baseline and 3 months|||pg/mL||Standard Deviation|Mean
693741|NCT01410604|Primary|High-sensitivity C-reactive Protein|Change from baseline in High-sensitivity C-reactive protein after 3 months of treatment.|baseline and 3 months|||mg/dL||Standard Deviation|Mean
693742|NCT01410604|Primary|Adiponectin|Change from baseline in Adiponectin after 3 months of treatment.|baseline and 3 months|||µg/mL||Standard Deviation|Mean
693743|NCT01410565|Secondary|Participants With Treatment Emergent Adverse Events (TEAEs)|TEAEs will be mainly characterized by the number of treatment emergent adverse events and treatment related AEs that occur or worsen after the first dose of study treatment.|24 Months from Randomization|All patients who received Apaziquone in the Open Label Phase and subsequently randomized to one of the treatment arms in the Double Blind Phase.||participants|||Number
693744|NCT01410565|Secondary|Recurrence Rate at 24 Months|Measurement the number of participants with the recurrence at 24 months.|24 months|All patients who received Apaziquone in the Open Label Phase and subsequently randomized to one of the treatment arms in the Double Blind Phase.||participants|||Number
699917|NCT00025506|Secondary|Overall Survival|The observed length of life from entry into the study to death or the date of last contact.|From study entry to death or last contact, up to 5 years.|Eligible and treated patients.||months||95% Confidence Interval|Median
693745|NCT01410565|Primary|Time to Recurrence|Time to recurrence is the time from randomization to the date of first histologically confirmed recurrence of bladder cancer (for eligible patients with Low- intermediate risk NMIBC, who had undergone TURBT followed by, a single instillation of apaziquone immediately post TURBT and multiple instillations of apaziquone or placebo).|Recurrence of cancer in the bladder during 24 months of follow-up|All patients who received Apaziquone in the Open Label Phase and subsequently randomized to one of the treatment arms in the Double Blind Phase. Participants without recurrence were censored.||months||Full Range|Mean
693746|NCT01410474|Secondary|Number of Subjects Who Reported Solicited Local and Systemic AEs After MenACWY-CRM Vaccination, Age 6 to 18 Years|Safety was assessed as the number of subjects aged 6 to 18 years who reported solicited local and systemic AEs within days 1 through 7 after MenACWY-CRM vaccination.|From day 1 through day 7 postvaccination|Analysis was done on safety population.||Subjects|||Number
693747|NCT01410474|Secondary|Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After MenACWY-CRM Vaccination, Age 2 to 5 Years|Safety was assessed as the number of subjects aged 2 to 5 years who reported solicited local and systemic adverse events (AEs) within days 1 through 7 after MenACWY-CRM vaccination.|From day 1 through day 7 postvaccination|Analysis was done on safety population i.e. the subjects in the exposed population who provided post-baseline safety data.||Subjects|||Number
693748|NCT01410474|Secondary|Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination|Immunogenicity was measured as the percentage of subjects with hSBA titer ≥1:8 and associated 95% CI, before vaccination (Day 1) and 28 days after MenACWY-CRM vaccination (Day 29), bye age group and overall.|Day 1 and 29|Analysis was done on MITT population||Percentages of Subjects||95% Confidence Interval|Number
693749|NCT01410474|Secondary|Geometric Mean Ratios (GMRs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination|Immunogenicity was measured as ratio of postvaccination GMTs to prevaccination GMTs and associated 95% CI, against N. meningitidis serogroups A, C, W and Y, at 28 days after MenACWY-CRM vaccination (Day 29), by age group and overall.|Day 1 and Day 29|Analysis was done on MITT population||Ratio||95% Confidence Interval|Geometric Mean
693750|NCT01410474|Secondary|Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination|Immunogenicity was measured as hSBA GMTs and associated 95% CI, against N. meningitidis serogroups A, C, W and Y, before the vaccination (Day 1) and 28 days after MenACWY-CRM vaccination (Day 29), by age group and overall.|Day 1 and 29|Analysis was done on MITT population||hSBA Titers||95% Confidence Interval|Geometric Mean
693751|NCT01410474|Secondary|Percentage of Subjects With Seroresponse, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination, by Age Group|"Immunogenicity was measured as the percentage of subjects with hSBA response and associated 95% CI, directed against N. meningitidis serogroups A, C, W and Y, at Day 29, by age groups.
Seroresponse is defined as:
for subjects with a prevaccination hSBA titer <1:4, a postvaccination hSBA titer ≥1:8.
for subjects with a prevaccination hSBA titer ≥1:4, an increase in hSBA titer of at least four times the prevaccination titer."|Day 1 and Day 29|Analysis was done on MITT population||Percentages of Subjects||95% Confidence Interval|Number
693752|NCT01410474|Primary|Percentage of Overall Subjects With Seroresponse, Directed Against Neisseria Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination|"Immunogenicity was measured as the percentage of subjects with hSBA seroresponse and associated 95% Clopper-Pearson confidence interval (CI), directed against N. meningitidis serogroups A, C, W and Y, evaluated by serum bactericidal assay using human complement (hSBA), at 28 days after one vaccination of MenACWY-CRM (day 29).
Seroresponse is defined as:
for subjects with a prevaccination hSBA titer <1:4, a postvaccination hSBA titer ≥1:8.
for subjects with a prevaccination hSBA titer ≥1:4, an increase in hSBA titer of at least four times the prevaccination titer."|Day 1 and Day 29|Analysis was done on modified intention-to-treat (MITT) population i.e subjects in the exposed population who provided evaluable serum samples whose assay results were available for at least one serogroup on day 1 and/or day 29.||Percentages of Subjects||95% Confidence Interval|Number
693753|NCT01410448|Secondary|Percentage of Participants With a New Onset of Diabetes|The percentage of participants with a new onset of diabetes was assessed.|12 months|Participants from the modified ITT, who had values at 12 months, were analyzed. The modified ITT included participants who completed the Core Phase (at 3 months) without discontinuing the treatment and performed the subsequent follow-up evaluation at 12 months after transplant.||Percentage of participants|||Number
693754|NCT01410448|Secondary|Percentage of Participants With a New Onset of Malignancy|The percentage of participants with a new onset of malignancy was assessed.|12 months|Participants from the modified ITT, who had values at 12 months, were analyzed. The modified ITT included participants who completed the Core Phase (at 3 months) without discontinuing the treatment and performed the subsequent follow-up evaluation at 12 months after transplant.||Percentage of participants|||Number
693755|NCT01410448|Secondary|Percentage of Participants With Acute Rejection (AR)|AR was defined as an episode of increased serum creatinine >30% that was clinically diagnosed as an acute rejection but was not biopsy proven.|12 months|The intent to treat (ITT) population, which included all randomized participants who were treated, was analyzed.||Percentage of participants|||Number
693756|NCT01410448|Secondary|Percentage of Participants With Proteinuria|Incidence of proteinuria (>1,000 mg/day in urine collected in 24 hours or > 1.0 if measured on the urine protein/creatinine concentration ratio in a spot urine sample) was assessed.|3 months|The intent to treat (ITT) population, which included all randomized participants who were treated, was analyzed.||Percentage of participants|||Number
693757|NCT01410448|Secondary|Change From Baseline in Serum Creatinine - Modified ITT|Blood samples were collected to assess serum creatinine measurements. A negative change from baseline indicates improvement.|baseline, 12 months|Participants from the modified ITT, who had both baseline and month 12 measurements, were included in the analysis for the month 12 time point. The modified ITT included participants who completed the Core Phase (at 3 months) without discontinuing the treatment and performed the subsequent follow-up evaluation at 12 months after transplant.||mg/dL||Standard Deviation|Mean
693801|NCT01410357|Primary|Clinical Global Impression (CGI) at 60 Weeks|The Clinical Global Impression (CGI) is a broad measure of global psychopathology that evaluates illness severity on a 1 to 7 point continuum. Possible scores range from 0 to 7, with higher scores indicating greater psychopathology.|60 weeks|||scores on a scale||Standard Deviation|Mean
693758|NCT01410448|Secondary|Change From Baseline in Serum Creatinine - ITT|Blood samples were collected to assess serum creatinine measurements. A negative change from baseline indicates improvement.|baseline, 3 months|Participants from the ITT, who had both baseline and the post-baseline measurement for a given post-baseline time point, were included in the analysis for that post-baseline time point. The ITT population included all randomized participants who were treated.||mg/dL||Standard Deviation|Mean
693759|NCT01410448|Secondary|Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) (Calculated With Modified Diet in Renal Disease (MDRD)-4 Formula - Modified ITT|Renal function was assessed by measuring serum creatinine and serum urea and by calculating creatinine clearance using the MDRD-4 formula. eGFR = 186.3*(serum creatinine [mg/dL])^-1.154 * (age at screening) -0.203 * (0.742 if female) * (1.21 if African American). A positive change from baseline indicates improvement.|baseline, 12 months|Participants from the modified ITT, who had both baseline and month 12 measurements, were included in the analysis for the month 12 time point. The modified ITT included participants who completed the Core Phase (at 3 months) without discontinuing the treatment and performed the subsequent follow-up evaluation at 12 months after transplant.||mL/min||Standard Deviation|Mean
693760|NCT01410448|Secondary|Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) (Calculated With Modified Diet in Renal Disease (MDRD)-4 Formula - ITT|Renal function was assessed by measuring serum creatinine and serum urea and by calculating creatinine clearance using the MDRD-4 formula. eGFR = 186.3*(serum creatinine [mg/dL])^-1.154 * (age at screening) -0.203 * (0.742 if female) * (1.21 if African American). A positive change from baseline indicates improvement.|baseline, 3 Months|Participants from the ITT, who had both baseline and month 3 measurements, were included in the analysis for the month 3 time point. The ITT population included all randomized participants who were treated.||mL/min||Standard Deviation|Mean
693761|NCT01410448|Secondary|Duration of DGF|The duration of DGF was defined as the elapsed time from first to last day of post-transplant dialysis.|3 months|Participants from the Intent-to-Treat (ITT) populations who required dialysis, 46 (23.83%) of the IE group and 60 (31.58%) of the DE group, were analyzed. The ITT population included all randomized participants who were treated.||Days||Full Range|Median
693762|NCT01410448|Secondary|Percentage of Participants With Delayed Graft Function (DGF) -|DGF was defined as the need for dialysis in the first week after transplant, excluding Renal Replacement Therapy within the first 24 hours after transplantation.|3 Months|The intent to treat (ITT) population, which included all randomized participants who were treated, was analyzed.||Percentage of participants|||Number
693763|NCT01410448|Secondary|Percentage of Participants With BPAR - Worst-case Scenario|A biopsy-proven acute rejection was defined as a biopsy graded IA, IB, IIA, IIB or III. In the worst-case scenario, failure, i.e. BPAR, was identified in one of the following cases: occurrence of BPAR or study discontinuation due to any reason.|3 Months, 12 months|The intent to treat (ITT) population, which included all randomized participants who were treated, was analyzed.||Percentage of participants|||Number
693764|NCT01410448|Secondary|Graft Survival Rate: Percentage of Participants With Graft Loss - Worst-case Scenario|The percentage of participants who experienced graft loss was assessed. In the worst-case scenario, failure, i.e. graft loss, was identified in one of the following cases: occurrence of graft loss or discontinuation due to any reason.|3 months, 12 months|The intent to treat (ITT) population, which included all randomized participants who were treated, was analyzed.||Percentage of participants|||Number
693765|NCT01410448|Secondary|Participant/Graft Survival Rate: Percentage of Participants With Failure Events of Death or Graft Loss - Worst-case Scenario|The percentage of participants who experienced death or graft loss was assessed. In the worst-case scenario, failure, i.e. participants death or graft loss, was identified in one of the following cases: occurrence of at least one failure event or study discontinuation due to any reason.|3 months|The intent to treat (ITT) population, which included all randomized participants who were treated, was analyzed.||Percentage of participants|||Number
693766|NCT01410448|Secondary|Patient Survival Rate: Percentage of Deaths - Worst-case Scenario|The percentage of deaths was assessed. In the worst-case scenario, failure, i.e. death, was identified in one of the following cases: participant's death or study discontinuation due to any reason.|3 Months, 12 months|The intent to treat (ITT) population, which included all randomized participants who were treated, was analyzed.||Percentage of participants|||Number
693767|NCT01410448|Secondary|Percentage of Participants Who Experienced Treatment Failure - Worst-case Scenario|The percentage of participants who experienced treatment failure was assessed. Treatment failure was defined as the occurrence of at least one failure event among death, graft loss or biopsy-proven acute rejection (BPAR). In the worst-case scenario, treatment failure was identified in one of the following cases: occurrence of at least one treatment failure event or study discontinuation due to any reason.|3 months|The intent to treat (ITT) population, which included all randomized participants who were treated, was analyzed.||Percentage of participants|||Number
693768|NCT01410448|Secondary|Percentage of Participants Without Wound Healing Complications - Worst-case Scenario|The percentage of participants without wound healing complications was assessed. Wound healing complications consisted of lymphorrhea, fluid collections, wound dehiscence, wound infections and incisional hernia. In the worst-case scenario, failure, i.e. at least one healing complication occurrence, was identified in one of the following cases: wound complication occurrence, missing information about wound complication occurrence or study discontinuation due to any reason for participants who did not complete the 12 month follow-up visit.|12 months|The safety population, which included all randomized participants who were treated and had at least one safety assessment, was analyzed.||Percentage of participants|||Number
693769|NCT01410448|Primary|Percentage of Participants Without Wound Healing Complications - Worst-case Scenario|The percentage of participants without wound healing complications was assessed. Wound healing complications consisted of lymphorrhea, fluid collections, wound dehiscence, wound infections and incisional hernia. In the worst-case scenario, failure, i.e. at least one healing complication occurrence, was identified in one of the following cases: wound complication occurrence, missing information about wound complication occurrence, or study discontinuation due to any reason.|3 months|The safety population, which included all randomized participants who were treated and had at least one safety assessment, was analyzed.||Percentage of participants|||Number
694149|NCT01405027|Secondary|Number of Participants With Adverse Events|Description of the adverse events and rate of events of boceprevir, peginterferon and ribavirin in HCV patients treated at community sites and at HCEEs|Throughout entire study, at end of treatment and follow up week 24|||participants|||Number
693779|NCT01410357|Other Pre-specified|Comparison of PMHSMS (Perceived Mental Health Self-Management Scale) Score Between TTIM and TAU at 60 Weeks|The Perceived Mental Health Self-Management Scale is an 8-item Likert scale, with each question ranging from 1-5. Total summed scores range from 8-40, with higher scores indicating higher perceived self-management competence in regards to mental health.|60 weeks|While 74 participants completed the TTIM arm and 76 completed TAU, there was some missing data for this scale, resulting in 70 TTIM and 74 TAU.||scores on a scale||Standard Deviation|Mean
693780|NCT01410357|Other Pre-specified|Comparison of PDSMS (Perceived Diabetes Self Management Scale)Score Between TTIM and TAU at 60 Weeks|The Perceived Diabetes Self-Management Scale is an 8-item Likert scale, with each question ranging from 1-5. Items 1, 2, 6, and 7 are reverse coded. Total summed scores range from 8-40, with higher scores indicating higher perceived self-management competence in regards to diabetes.|60 weeks|While 74 participants completed the TTIM arm and 76 completed TAU, there was some missing data for this scale, resulting in 67 TTIM and 72 TAU.||scores on a scale||Standard Deviation|Mean
693781|NCT01410357|Other Pre-specified|Comparison of MSPSS (Multidimensional Scale of Perceived Social Support) Score Between TTIM and TAU at 60 Weeks|The Multidimensional Scale of Perceived Social Support is a 12 question Likert scale, with each item ranging from 1-5. Total scores range from 12-60, with higher scores indicating more perceived social support.|60 weeks|While 74 participants completed the TTIM arm and 76 completed TAU, there was some missing data for this scale, resulting in 73 TTIM and 74 TAU.||scores on a scale||Standard Deviation|Mean
693782|NCT01410357|Other Pre-specified|Comparison of Diabetes Knowledge Score Between TTIM and TAU at 60 Weeks|The diabetes knowledge score has 23 questions which assess how much knowledge one has about diabetes. They are in multiple choice format, with 4 choices, and only one is correct. The total amount correct is added up, and then calculated into a percentage of answers correct.|60 weeks|While 74 participants completed the TTIM arm and 76 completed TAU, there was some missing data for this scale, resulting in 73 TTIM and 74 TAU.||percent correct||Standard Deviation|Mean
693783|NCT01410357|Other Pre-specified|Comparison of Utilization (Mental Hospital) Score Between TTIM and TAU at 60 Weeks|The Utilization of Mental Hospital score looks at how many times a participant used these resources. Analyses include a simple mean and SD.|60 weeks|While 74 participants completed the TTIM arm and 76 completed TAU, there was some missing data for this scale, resulting in 73 TTIM and 74 TAU.||time utilized||Standard Deviation|Mean
693784|NCT01410357|Other Pre-specified|Comparison of Utilization (Mental Ed) Score Between TTIM and TAU at 60 Weeks|The Utilization of Mental Education score looks at how many times a participant used these resources. Analyses include a simple mean and SD.|60 weeks|While 76 completed TAU, there was some missing data for this scale, resulting in 74 TAU.||times utilized||Standard Deviation|Mean
693786|NCT01410357|Secondary|Comparison of ISMI (Stigma Resistance) Score Between TTIM and TAU at 60 Weeks|The ISMI (Internalized Stigma of Mental Illness) has 29 questions, broken into 5 subscales. This subscale, Stigma Resistance, has 5 Likert-scale items. Each question is rated as 0= strongly disagree, 1= disagree, 2= neutral, 3= agree, 4= strongly agree. These scores are all reverse coded. Total scores on the Stigma Resistance subscale range from 0-20, with higher scores reflecting higher levels of reported internalized stigma of mental illness.|60 weeks|While 74 participants completed the TTIM arm and 76 completed TAU, there was some missing data for this scale, resulting in 70 TTIM and 74 TAU.||scores on a scale||Standard Deviation|Mean
693787|NCT01410357|Secondary|Comparison of ISMI (Social Withdrawal) Score Between TTIM and TAU at 60 Weeks|The ISMI (Internalized Stigma of Mental Illness) has 29 questions, broken into 5 subscales. This subscale, Social Withdrawal, has 6 Likert-scale items. Each question is rated as 1= strongly disagree, 2= disagree, 3= neutral, 4= agree, 5= strongly agree. Total scores on the Social Withdrawal subscale range from 6-30, with higher scores reflecting higher levels of reported internalized stigma of mental illness.|60 weeks|While 74 participants completed the TTIM arm and 76 completed TAU, there was some missing data for this scale, resulting in 70 TTIM and 74 TAU.||scores on a scale||Standard Deviation|Mean
693788|NCT01410357|Secondary|Comparison of ISMI (Discrimination Experience) Between TTIM and TAU at 60 Weeks|The ISMI (Internalized Stigma of Mental Illness) has 29 questions, broken into 5 subscales. This subscale, Discrimination Experience, has 5 Likert-scale items. Each question is rated as 1= strongly disagree, 2= disagree, 3= neutral, 4= agree, 5= strongly agree. Total scores on the Discrimination Experience subscale range from 5-25, with higher scores reflecting higher levels of reported internalized stigma of mental illness.|60 weeks|While 74 participants completed the TTIM arm and 76 completed TAU, there was some missing data for this scale, resulting in 70 TTIM and 74 TAU.||scores on a scale||Standard Deviation|Mean
693789|NCT01410357|Secondary|Comparison of ISMI (Stereotype Endorsement) Score Between TTIM and TAU at 60 Weeks|The ISMI (Internalized Stigma of Mental Illness) has 29 questions, broken into 5 subscales. This subscale, Stereotype Endorsement, has 7 Likert-scale items. Each question is rated as 1= strongly disagree, 2= disagree, 3= agree, 4= strongly agree. Total scores on the Stereotype Endorsement subscale range from 7-28, with higher scores reflecting higher levels of reported internalized stigma of mental illness.|60 weeks|While 74 participants completed the TTIM arm and 76 completed TAU, there was some missing data for this scale, resulting in 69 TTIM and 74 TAU.||scores on a scale||Standard Deviation|Mean
693790|NCT01410357|Secondary|Comparison of ISMI (Internalized Stigma of Mental Illness -Alienation) Between TTIM and TAU at 60 Weeks|The ISMI (Internalized Stigma of Mental Illness) has 29 questions, broken into 5 subscales. This subscale, Alienation, has 6 Likert-scale items. Each question is rated as 1= strongly disagree, 2= disagree, 3= neutral, 4= agree, 5= strongly agree. Total scores on the Alienation subscale range from 6-30, with higher scores reflecting higher levels of reported internalized stigma of mental illness.|60 weeks|While 74 participants completed the TTIM arm and 76 completed TAU, there was some missing data for this scale, resulting in 70 TTIM and 74 TAU.||scores on a scale||Standard Deviation|Mean
693791|NCT01410357|Secondary|Comparison of AUDIT (Alcohol Use Disorders Identification Test) Score Between TTIM and TAU (Treatment as Usual) at 60 Weeks|The AUDIT scale (Alcohol Use Disorders Identification Test) has 10 questions, with scores on each question ranging from 0 to 4 (0= never, 1= less than monthly, 2= monthly, 3= weekly 4= daily/almost daily). Questions 9 and 10 only have three anchors: 0, 2, and 4. The scores are summed to get total. Therefore, the range of possible scores are 0-40, with higher scores indicating indicating a greater likelihood of hazardous and harmful drinking. However, such scores may also reflect greater severity of alcohol problems and dependence, as well as a greater need for more intensive treatment.|60 weeks|While 74 participants completed the TTIM arm and 76 completed TAU, there was some missing data for this scale, resulting in 69 TTIM and 73 TAU.||Scores on a scale||Standard Deviation|Mean
693792|NCT01410357|Secondary|Self-rated Diabetes Self-Care Activities (SDSCA) Questionnaire at 60 Weeks|The SDSCA measure is a brief self-report questionnaire of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: general diet, specific diet, exercise, blood-glucose testing, foot care, and smoking. It is comprised of 10 questions, to which each have a 5 point scale with anchors 1= never through 5= always. The items are summed to a total score, which ranges from 10-50.|60 weeks|||scores on a scale||Standard Deviation|Mean
693793|NCT01410357|Secondary|Tablets Routine Questionnaire (TRQ) at 60 Weeks|The self-reported Tablets Routine Questionnaire (TRQ) measures change in treatment adherence. The TRQ determines proportion of prescribed medication missed, and ranges from 0 (no medication missed/100% adherent) to 100 (no medication taken/0% adherent). The TRQ format captured an exact proportion (%) of days with a missed medication dose for each oral maintenance psychotropic medication and then an average combined TRQ was calculated for all orally-prescribed medications.|60 weeks|||percentage of days adherent||Standard Deviation|Mean
693794|NCT01410357|Primary|SF-36 Health Survey at 60 Weeks; Physical Health Component|The Short Form 36 Health Survey (SF-36) is a self-report of general health divided into a physical component summary (PCS) and mental component summary (MCS). Norm-based scores are placed on the same metric with a mean of 50 and standard deviation of 10. Scores above 50 reflect higher functional status than the average population and scores below 50 reflect lower than average function.|60 weeks|||scores on a scale||Standard Deviation|Mean
693795|NCT01410357|Primary|Body Mass Index (BMI) at 60 Weeks||60 weeks|||kg/m^2||Standard Deviation|Mean
693796|NCT01410357|Primary|Systolic Blood Pressure at 60 Weeks||60 weeks|||mmHg||Standard Deviation|Mean
693797|NCT01410357|Primary|Glycosylated Hemoglobin (HbA1c) at 60 Weeks||60 weeks|||mmol/mol||Standard Deviation|Mean
693798|NCT01410357|Primary|SF-36 (Short-form) Health Survey at 60 Weeks; Mental Health Component|The Short Form 36 Health Survey (SF-36) is a self-report of general health divided into a physical component summary (PCS) and mental component summary (MCS). Norm-based scores are placed on the same metric with a mean of 50 and standard deviation of 10. Scores above 50 reflect higher functional status than the average population and scores below 50 reflect lower than average function.|60 weeks|||scores on a scale||Standard Deviation|Mean
693799|NCT01410357|Primary|Sheehan Disability Scale (SDS) at 60 Weeks|The SDS measures role impairment in three domains (work/school; family life/home; social life). Possible total scores range from 0 to 30, with higher scores indicating greater disability. Only the total score was reported in our analyses, and is denoted here. The total score is calculated by summing the three domain scores, each which range from 0-10.|60 weeks|||scores on a scale||Standard Deviation|Mean
693803|NCT01410357|Primary|Brief Psychiatric Rating Scale (BPRS) at 60 Weeks|The BPRS measures psychotic and non-psychotic symptoms in serious mental illness. Possible total scores range from 7 to 126, with higher scores indicating greater symptom severity. For this study, the BPRS with 18 items was used. Each symptom measured ranges from 1-7, and all 18 items/symptoms are summed to create the total score. Only the BPRS total score was utilized in the analyses.|60 weeks|||scores on a scale||Standard Deviation|Mean
693804|NCT01410240|Secondary|Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk|The number of participants responding affirmative in their rehabilitation diaries for each day|60 days|Full Analysis Set||participants|||Number
693805|NCT01410240|Secondary|Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed|The number of participants responding affirmative in their rehabilitation diaries for each day|60 days|Full Analysis Set||participants|||Number
693806|NCT01410240|Secondary|Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair)|The number of participants responding affirmative in their rehabilitation diaries for each day|60 days|Full Analysis Set||participants|||Number
693807|NCT01410240|Secondary|Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair|The number of participants responding affirmative in their rehabilitation diaries for each day|60 days|Full Analysis Set||participants|||Number
693808|NCT01410240|Secondary|Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane|The number of participants responding affirmative in their rehabilitation diaries for each day|60 days|Full Analysis Set||participants|||Number
693809|NCT01410240|Secondary|Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker|The number of participants responding affirmative in their rehabilitation diaries for each day|60 days|Full Analysis Set||participants|||Number
693810|NCT01410240|Secondary|Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance|The number of participants responding affirmative in their rehabilitation diaries for each day|60 days|Full Analysis Set||participants|||Number
693811|NCT01410240|Secondary|Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist|The number of participants responding affirmative in their rehabilitation diaries for each day|60 days|Full Analysis Set||participants|||Number
693812|NCT01410240|Secondary|Proportion of Participants With Any Adverse Events or Serious Injuries During or After Surgery||Day 0; Post-operative Days 1, 3 and Weeks 1, 2, 6|"Safety Analysis Set
Note: The FLOSEAL (+ Standard of Care (SoC)) Arm/Group Includes the 12 Run-In participants"||Proportion of participants||95% Confidence Interval|Number
693813|NCT01410240|Secondary|Proportion of Participants With Wound Complications (ie, Hematoma, Cellulitis, Dehiscence, Superficial or Deep Infection, and Persistent Drainage)||Day 0; Post-operative Days 1, 3 and Weeks 1, 2, 6|"Safety Analysis Set
Note: The FLOSEAL (+ Standard of Care (SoC)) Arm/Group Includes the 12 Run-In participants"||Proportion of participants||95% Confidence Interval|Number
693814|NCT01410240|Secondary|Proportion of Participants With Transfusion Requirements||Intra-operative|"Safety Analysis Set
Note: The FLOSEAL (+ Standard of Care (SoC)) Arm/Group Includes the 12 Run-In participants"||Proportion of participants||95% Confidence Interval|Number
693815|NCT01410240|Secondary|Length of Hospital Stay||From the day of hospitalization to the day of discharge|Full Analysis Set||Days||Standard Deviation|Mean
693816|NCT01410240|Primary|Proportion of Participants Who Have Adverse Events Related to Investigational Product (IP)|"Proportion of Participants who have serious injuries (SIs) related to IP
Proportion of Participants who have non-serious adverse events (non-SAEs) related to IP"|Throughout the study period, 1 year and 4 months|"Safety Analysis Set
Note: The FLOSEAL (+ Standard of Care (SoC)) Arm/Group Includes the 12 Run-In participants"||Proportion of participants||95% Confidence Interval|Number
693817|NCT01410240|Secondary|Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6|"Physical Functioning (PF); Role Limitation Due to Physical Health (RP); Bodily Pain (BP); General Health (GH); Vitality (VT); Social Functioning (SF); Role Limitation Due to Emotional Problems (RE); Mental Health (MH), Physical Component Score (PCS); Mental Component Score (MCS). Scores range 0-100, higher scores represent better health. There is no total overall score; scoring is done for subscores and summary scores. Scores were included where data was available.
Change in SF-36 Scores From Baseline = (Postoperative Week 1,2, or 6 Scores) – (Baseline Scores)."|Baseline and Postoperative Weeks 1, 2, and 6|||Scores on a scale||Standard Deviation|Mean
693818|NCT01410240|Secondary|Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6|Physical Functioning (PF); Role Limitation Due to Physical Health (RP); Bodily Pain (BP); General Health (GH); Vitality (VT); Social Functioning (SF); Role Limitation Due to Emotional Problems (RE); Mental Health (MH), Physical Component Score (PCS); Mental Component Score (MCS). Scores range 0-100, higher scores represent better health. There is no total overall score; scoring is done for subscores and summary scores. Scores were included where data was available.|Preoperative, and Postoperative Weeks 1, 2, and 6|Full Analysis Set||Scores on a scale||Standard Deviation|Mean
693819|NCT01410240|Secondary|Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores|"A well-validated scale to reflect problems in people with lower limb issues.
Pain scale (5 items): 0 (none) to 10 (extreme pain) is used to grade each item, higher scores indicate greater pain. The overall pain scale = 0 (no pain) to 50 (extreme pain)
Stiffness scale (2 items): 0 (none) to 10 (extreme stiffness) is used to grade each item, higher scores indicate greater stiffness. The overall stiffness scale = 0 (no stiffness) to 20 (extreme stiffness)
Physical Activity Difficulty (PAD) scale (17 items): 0 (none) to 10 (extreme PAD) is used to grade each item, with higher scores indicating greater PAD. The overall PAD scale = 0 (no PAD) to 170 (extreme PAD) Averages calculated by taking sum of all individual item scores listed above and dividing by total number of items, range = 0 (no issues) to 10 (extreme issues).
Total Scores calculated by taking sum of all individual item scores listed above, range = 0 (no issues) to 240 (extreme issues).
Postoperative (Postop)"|Pre-operatively (Day -1 to Day 0), and post-operatively at Day 3 and Week 1, 2 and 6|Full Analysis Set||score on a scale||Standard Deviation|Mean
693924|NCT01409837|Primary|Proportion of Sperm Cells With Normal Motility (%)|This was determined as the proportion (percent) of the total sperm cells exhibiting both rhythmic and propulsive movements considered to be of normal intensity.|Week 96|All the patients randomized into each group was analyzed on the basis of intention-to-treat||Per cent||Standard Deviation|Geometric Mean
693820|NCT01410240|Secondary|Western Ontario and McMaster Universities (WOMAC) Function Index Scores|"A well-validated scale to reflect problems in people with lower limb issues.
Pain scale (5 items): 0 (none) to 10 (extreme pain) is used to grade each item, higher scores indicate greater pain. The overall pain scale = 0 (no pain) to 50 (extreme pain)
Stiffness scale (2 items): 0 (none) to 10 (extreme stiffness) is used to grade each item, higher scores indicate greater stiffness. The overall stiffness scale = 0 (no stiffness) to 20 (extreme stiffness)
Physical Activity Difficulty (PAD) scale (17 items): 0 (none) to 10 (extreme PAD) is used to grade each item, with higher scores indicating greater PAD. The overall PAD scale = 0 (no PAD) to 170 (extreme PAD)
Averages calculated by taking sum of all individual item scores listed above and dividing by total number of items, range = 0 (no issues) to 10 (extreme issues).
Total Scores calculated by taking sum of all individual item scores listed above, range = 0 (no issues) to 240 (extreme issues)
Postoperative (Postop)"|Pre-operatively (Day -1 to Day 0), and post-operatively at Day 3 and Week 1, 2 and 6|Full Analysis Set||score on a scale||Standard Deviation|Mean
693821|NCT01410240|Secondary|Change From Baseline in Visual Analogue Scale (VAS) Pain Scores at Postoperative Week 6|Participant rated assessment of the level of pain they are experiencing with their operated knee. The VAS Pain Scale rates pain on a scale from 0 (no pain) to 10 (worst possible pain). For the pain scale, a higher score indicates worse pain.|Pre-operatively (Day -1 to Day 0) and post-operatively at Week 6|Full Analysis Set||score on a scale||Standard Deviation|Mean
693822|NCT01410240|Secondary|Change From Baseline in Visual Analogue Scale (VAS) Pain Scores at Postoperative Week 2|Participant rated assessment of the level of pain they are experiencing with their operated knee. The VAS Pain Scale rates pain on a scale from 0 (no pain) to 10 (worst possible pain). For the pain scale, a higher score indicates worse pain.|Pre-operatively (Day -1 to Day 0) and post-operatively at Week 2|Full Analysis Set||score on a scale||Standard Deviation|Mean
693823|NCT01410240|Secondary|Change From Baseline in Visual Analogue Scale (VAS) Pain Scores at Postoperative Week 1|Participant rated assessment of the level of pain they are experiencing with their operated knee. The VAS Pain Scale rates pain on a scale from 0 (no pain) to 10 (worst possible pain). For the pain scale, a higher score indicates worse pain.|Pre-operatively (Day -1 to Day 0) and post-operatively at Week 1|Full Analysis Set||score on a scale||Standard Deviation|Mean
693824|NCT01410240|Secondary|Change From Baseline in Visual Analogue Scale (VAS) Pain Scores at Postoperative Day 3|Participant rated assessment of the level of pain they are experiencing with their operated knee. The VAS Pain Scale rates pain on a scale from 0 (no pain) to 10 (worst possible pain). For the pain scale, a higher score indicates worse pain.|Pre-operatively (Day -1 to Day 0) and post-operatively at Day 3|Full Analysis Set||score on a scale||Standard Deviation|Mean
693825|NCT01410240|Secondary|Visual Analogue Scale (VAS) Pain Scores|Participant rated assessment of the level of pain they are experiencing with their operated knee. The VAS Pain Scale rates pain on a scale from 0 (no pain) to 10 (worst possible pain). For the pain scale, a higher score indicates worse pain.|Pre-operatively (Day -1 to Day 0) and post-operatively at Day 3, Week 1, 2 and 6|Full Analysis Set||score on a scale||Standard Deviation|Mean
693826|NCT01410240|Secondary|Pain Management - Number of Days When Pain Medication Was Used|"Each participant kept a knee pain management diary. The diary was used to document the pain medication taken on a daily basis.
While the participants were hospitalized, either they filled out the diary, or study team members collected the pain diary data and filled out the diary."|Pre-operatively (Day -1 to Day 0); and post-operatively daily thru week 6|Full Analysis Set||days||Standard Deviation|Mean
693827|NCT01410240|Secondary|Total Drain Output at Day 1 Post-operatively||1 day post-operatively|Full Analysis Set||mL||Standard Deviation|Mean
693828|NCT01410240|Secondary|Transfusion Requirements - Packed Red Blood Cells||Intra-operatively (Day 0) thru Postoperative Day 3|Full Analysis Set - participants with transfusion requirement||mL||Standard Deviation|Mean
693829|NCT01410240|Secondary|Duration of Surgery||Time from first incision to complete wound closure (Day 0)|Full Analysis Set||minutes||Standard Deviation|Mean
693830|NCT01410240|Secondary|Amount of FLOSEAL Applied||Intra-operatively (Day 0)|"Safety Analysis Set
Note: The FLOSEAL (+ Standard of Care (SoC)) Arm/Group Includes the 15 Run-In participants"||mL||Standard Deviation|Mean
693831|NCT01410240|Secondary|Total Tourniquet Time|Measured from the time point of the tourniquet inflation to deflation using the same watch/clock|Intra-operatively (on day of surgery = Day 0)|Full Analysis Set||minutes||Standard Deviation|Mean
693832|NCT01410240|Secondary|Change From Baseline in Hematocrit (Hct) at Postoperative Day 3||Pre-operative and day 3 post-operatively|"Full Analysis Set
Participants who required a transfusion prior to the outcome assessments were excluded from the efficacy analyses of Hct levels."||percent||Standard Deviation|Mean
693833|NCT01410240|Secondary|Change From Baseline in Hematocrit (Hct) at Postoperative Day 2||Pre-operative and day 2 post-operatively|"Full Analysis Set
Participants who required a transfusion prior to the outcome assessments were excluded from the efficacy analyses of Hct levels."||percent||Standard Deviation|Mean
693834|NCT01410240|Secondary|Change From Baseline in Hematocrit (Hct) at Postoperative Day 1|Participants who required a transfusion prior to the outcome assessments were excluded from the efficacy analyses of Hct levels.|Pre-operative and day 1 post-operatively|"Full Analysis Set
Participants who required a transfusion prior to the outcome assessments were excluded from the efficacy analyses of Hct levels."||percent||Standard Deviation|Mean
693835|NCT01410240|Secondary|Change in Hemoglobin (Hgb) Levels at Day 3 Post-operatively|Participants who required a transfusion prior to the outcome assessments were excluded from the efficacy analyses of Hgb levels.|Pre-operative and day 3 post-operatively|"Full Analysis Set
Participants who required a transfusion prior to the outcome assessments were excluded from the efficacy analyses of Hgb levels."||g/dL||Standard Deviation|Mean
693836|NCT01410240|Secondary|Change in Hemoglobin (Hgb) Levels at Day 1 Post-operatively||Pre-operative and day 1 post-operatively|"Full Analysis Set
Participants who required a transfusion prior to the outcome assessments were excluded from the efficacy analyses of Hgb levels."||g/dL||Standard Deviation|Mean
693837|NCT01410240|Primary|Change in Hemoglobin (Hgb) Level at Day 2 Post-operatively||Pre-operative and 2 days post-operatively|"Full Analysis Set
Participants who required a transfusion prior to the primary outcome assessment of Hgb level at postoperative Day 2 were excluded from the primary outcome analysis."||g/dL||Standard Deviation|Mean
699995|NCT00033371|Secondary|Percent Change in the Area of Plaque-like Duodenal Polyps|The two-sample t-test or its non-parametric analogue, the Wilcoxon rank sums test will be used.|Baseline up to 2 months after completion of study treatment||||||
693838|NCT01410227|Secondary|PK80- Ratio of Intra-participant PK of VWF:RCo, VWF:Ag and VWF:CB at Baseline and After 6 Months|Area under the plasma concentration curve (AUC) from time 0 to infinity per dose (AUC0-∞/dose) for von Willebrand Factor Ristocetin cofactor (VWF:RCo), von Willebrand Factor Antigen (VWF:Ag) and von Willebrand Factor Collagen Binding (VWF:CB). Each parameter was compared between the two PK assessments after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. 13 participants had data available for this endpoint i.e. data for PK1 and PK2.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|Participants from the PK80 Arm who had pharmacokinetic (PK) data available after both the first infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] [PK1] and the second infusion of 80 IU/kg rVWF [PK2].||ratio of AUC0-∞/dose||90% Confidence Interval|Geometric Mean
693839|NCT01410227|Secondary|PK80 - Area Under the Plasma Concentration/Time Curve From Time 0 to 96 Hours (AUC0-96h/Dose) of FVIII:C|Area under the plasma concentration curve (AUC) from time 0 to 96 hours of Factor VIII activity (FVIII:C) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||(hours*U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
693840|NCT01410227|Secondary|PK80 - Area Under the Plasma Concentration/Time Curve From Time 0 to Infinity (AUC0-∞/Dose) of FVIII:C|Area under the plasma concentration curve (AUC) from time 0 to infinity of Factor VIII activity (FVIII:C) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||(hours*U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
693841|NCT01410227|Secondary|PK80 - Volume of Distribution at Steady State of VWF:CB|Volume of Distribution at Steady State (Vss) of von Willebrand Factor Collagen Binding (VWF:CB) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||dL/kg||95% Confidence Interval|Median
693842|NCT01410227|Secondary|PK80 - Elimination Phase Half-Life of VWF:CB|Elimination Phase Half-Life (T1/2) of von Willebrand Factor Collagen Binding (VWF:CB) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||hours||95% Confidence Interval|Median
693843|NCT01410227|Secondary|PK80 - Incremental Recovery of VWF:CB|Incremental Recovery (IR) at the maximum plasma concentration Area under the plasma concentration curve (AUC) from time 0 to infinity of von Willebrand Factor Collagen Binding (VWF:CB) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||(U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
693844|NCT01410227|Secondary|PK80 - Clearance of VWF:CB|Clearance (CL) of von Willebrand Factor Collagen Binding (VWF:CB) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||dL/kg/hours||95% Confidence Interval|Median
693845|NCT01410227|Secondary|PK80 - Mean Residence Time of VWF:CB|Mean Residence Time (MRT) of von Willebrand Factor Collagen Binding (VWF:CB) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||hours||95% Confidence Interval|Median
693846|NCT01410227|Secondary|PK80 - Area Under the Plasma Concentration/Time Curve From Time 0 to 96 Hours (AUC0-96h/Dose) of VWF:CB|Area under the plasma concentration curve (AUC) from time 0 to 96 hours of von Willebrand Factor Collagen Binding (VWF:CB) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participatns from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||(hours*U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
693847|NCT01410227|Secondary|PK80 - Area Under the Plasma Concentration/Time Curve From Time 0 to Infinity (AUC0-∞/Dose) of VWF:CB|Area under the plasma concentration curve (AUC) from time 0 to infinity of von Willebrand Factor Collagen Binding (VWF:CB) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||(hours*U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
693848|NCT01410227|Secondary|PK80 - Volume of Distribution at Steady State of VWF:Ag|Volume of Distribution at Steady State (Vss) of von Willebrand Factor Antigen (VWF:Ag) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||dL/kg||95% Confidence Interval|Median
693849|NCT01410227|Secondary|PK80 - Elimination Phase Half-Life of VWF:Ag|Elimination Phase Half-Life (T1/2) of von Willebrand Factor Antigen (VWF:Ag) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||hours||95% Confidence Interval|Median
693850|NCT01410227|Secondary|PK80 - Incremental Recovery of VWF:Ag|Incremental Recovery (IR) at the maximum plasma concentration Area under the plasma concentration curve (AUC) from time 0 to infinity of von Willebrand Factor Antigen (VWF:Ag) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||(U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
693851|NCT01410227|Secondary|PK80 - Clearance of VWF:Ag|Clearance (CL) of von Willebrand Factor Antigen (VWF:Ag) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||dL/kg/hours||95% Confidence Interval|Median
693925|NCT01409837|Primary|Total Sperm Cell Count Per Milliliter of Seminal Fluid.|the number of sperm cells counted per milliliter volume of seminal fluid|Week 96|All the patients randomized into each group were analyzed on the basis of intention-to-treat||Millions/ml||Standard Deviation|Mean
694455|NCT01401153|Primary|Tonic Alertness (Deviation of Reaction Time)|Deviation of reaction time --> logarithmic standard deviation of the reaction times|Participants were tested twice with one week wash out (1h after having/skipping lunch)|Complete case analysis||Unitless||Inter-Quartile Range|Median
693852|NCT01410227|Secondary|PK80 - Mean Residence Time of VWF:Ag|Mean Residence Time (MRT) of von Willebrand Factor Antigen (VWF:Ag) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||hours||95% Confidence Interval|Median
693853|NCT01410227|Secondary|PK80 - Area Under the Plasma Concentration/Time Curve From Time 0 to 96 Hours (AUC0-96h/Dose) of VWF:Ag|Area under the plasma concentration curve (AUC) from time 0 to 96 hours of von Willebrand Factor Antigen (VWF:Ag) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||(hours*U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
693854|NCT01410227|Secondary|PK80 - Area Under the Plasma Concentration/Time Curve From Time 0 to Infinity (AUC0-∞/Dose) of VWF:Ag|Area under the plasma concentration curve (AUC) from time 0 to infinity of von Willebrand Factor Antigen (VWF:Ag) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||(hours*U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
693855|NCT01410227|Secondary|PK80 - Volume of Distribution at Steady State of VWF:RCo|Volume of Distribution at Steady State (Vss) of von Willebrand Factor Ristocetin cofactor (VWF:RCo) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study. PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||dL/kg||95% Confidence Interval|Median
693856|NCT01410227|Secondary|PK80 - Elimination Phase Half-Life of VWF:Co|Elimination Phase Half-Life (T1/2) of von Willebrand Factor Ristocetin cofactor (VWF:RCo) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||hours||95% Confidence Interval|Median
693857|NCT01410227|Secondary|PK80 - Incremental Recovery of VWF:RCo|Incremental Recovery (IR) at the maximum plasma concentration Area under the plasma concentration curve (AUC) from time 0 to infinity of von Willebrand Factor Ristocetin cofactor (VWF:RCo) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||(U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
693858|NCT01410227|Secondary|PK80 - Clearance of VWF:RCo|Clearance (CL) of von Willebrand Factor Ristocetin cofactor (VWF:RCo) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||dL/kg/hours||95% Confidence Interval|Median
693943|NCT01409382|Primary|Neonatal Hypoglycemia|Any glucose level equal or below 40mg/dL at 1, 2 or 4 h after birth, obtained by heelstick.|1, 2 and 4 h after birth.|||neonates|Participants||Number
693944|NCT01409291|Secondary|Fast Food Meals Per Week|Mean number of fast food meals per week|1 year|||meals per week||Standard Deviation|Mean
693859|NCT01410227|Secondary|PK80 - Mean Residence Time of VWF:RCo|Mean Residence Time (MRT) of von Willebrand Factor Ristocetin cofactor (VWF:RCo) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||hours||95% Confidence Interval|Median
693860|NCT01410227|Secondary|PK80 - Area Under the Plasma Concentration/Time Curve From Time 0 to 96 Hours (AUC0-96h/Dose) of VWF:RCo|Area under the plasma concentration curve (AUC) from time 0 to 96 hours of von Willebrand Factor Ristocetin cofactor (VWF:RCo) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||(hours*U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
693861|NCT01410227|Secondary|PK80 - Area Under the Plasma Concentration/Time Curve From Time 0 to Infinity (AUC0-∞/Dose) of VWF:RCo|Area under the plasma concentration curve (AUC) from time 0 to infinity of von Willebrand Factor Ristocetin cofactor (VWF:RCo) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||(hours*U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
693862|NCT01410227|Secondary|PK50 - Volume of Distribution at Steady State of FVIII:C|Volume of Distribution at Steady State (Vss) of Factor VIII activity (FVIII:C) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII] for participants in the PK50 arms (Arm 1 and Arm 2).|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||dL/kg||95% Confidence Interval|Median
693863|NCT01410227|Secondary|PK50 - Elimination Phase Half-Life of FVIII:C|Elimination Phase Half-Life (T1/2) of Factor VIII activity (FVIII:C) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant FVIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII] for participants in the PK50 arms (Arm 1 and Arm 2).|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||hours||95% Confidence Interval|Median
693864|NCT01410227|Secondary|PK50 - Incremental Recovery of FVIII:C|Incremental Recovery (IR) at the maximum plasma concentration of Factor VIII activity (FVIII:C) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII] for participants in the PK50 arms (Arm 1 and Arm 2).|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||(U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
693865|NCT01410227|Secondary|PK50 - Clearance of FVIII:C|Clearance (CL) of Factor VIII activity (FVIII:C) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII] for participants in the PK50 arms (Arm 1 and Arm 2).|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||dL/kg/hours||95% Confidence Interval|Median
693866|NCT01410227|Secondary|PK50 - Mean Residence Time of FVIII:C|Mean Residence Time (MRT) of Factor VIII activity (FVIII:C) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII] for participants in the PK50 arms (Arm 1 and Arm 2).|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||hours||95% Confidence Interval|Median
693867|NCT01410227|Secondary|PK50 - Area Under the Plasma Concentration/Time Curve From Time 0 to 96 Hours (AUC0-96h/Dose) of FVIII:C|Area under the plasma concentration curve (AUC) from time 0 to 96 hours of Factor VIII activity (FVIII:C) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||hours*U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
693868|NCT01410227|Secondary|PK50 - Area Under the Plasma Concentration/Time Curve From Time 0 to Infinity (AUC0-∞/Dose) of FVIII:C|Area under the plasma concentration curve (AUC) from time 0 to infinity of Factor VIII activity (FVIII:C) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||hours*U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
693869|NCT01410227|Secondary|PK50 - Volume of Distribution at Steady State of VWF:CB|Volume of Distribution at Steady State (Vss) of von Willebrand Factor Collagen Binding (VWF:CB) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants[N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||dL/kg||95% Confidence Interval|Median
693870|NCT01410227|Secondary|PK50 - Elimination Phase Half-Life of VWF:CB|Elimination Phase Half-Life (T1/2) of von Willebrand Factor Collagen Binding (VWF:CB) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant FVIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||hours||95% Confidence Interval|Median
693871|NCT01410227|Secondary|PK50 - Incremental Recovery of VWF:CB|Incremental Recovery (IR) at the maximum plasma concentration of von Willebrand Factor Collagen Binding (VWF:CB) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||(U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
693872|NCT01410227|Secondary|PK50 - Clearance of VWF:CB|Clearance (CL) of von Willebrand Factor Collagen Binding (VWF:CB) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||dL/kg/hours||95% Confidence Interval|Median
693873|NCT01410227|Secondary|PK50 - Mean Residence Time of VWF:CB|Mean Residence Time (MRT) of von Willebrand Factor Collagen Binding (VWF:CB) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||hours||95% Confidence Interval|Median
693874|NCT01410227|Secondary|PK50 - Area Under the Plasma Concentration/Time Curve From Time 0 to 96 Hours (AUC0-96h/Dose) of VWF:CB|Area under the plasma concentration curve (AUC) from time 0 to 96 hours of von Willebrand Factor Collagen Binding (VWF:CB) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||(hours*U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
693875|NCT01410227|Secondary|PK50 - Area Under the Plasma Concentration/Time Curve From Time 0 to Infinity (AUC0-∞/Dose) of VWF:CB|Area under the plasma concentration curve (AUC) from time 0 to infinity of von Willebrand Factor Collagen Binding (VWF:CB) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||(hours*U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
693945|NCT01409291|Primary|Minutes of Exercise Per Week|Mean minutes of exercise per week|1 year|||minutes||Standard Deviation|Mean
693876|NCT01410227|Secondary|PK50 - Volume of Distribution at Steady State of VWF:Ag|Volume of Distribution at Steady State (Vss) of von Willebrand Factor Antigen (VWF:Ag) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||dL/kg||95% Confidence Interval|Median
693877|NCT01410227|Secondary|PK50 - Elimination Phase Half-Life of VWF:Ag|Elimination Phase Half-Life (T1/2) of von Willebrand Factor Antigen (VWF:Ag) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant FVIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||hours||95% Confidence Interval|Median
693878|NCT01410227|Secondary|PK50 - Incremental Recovery of VWF:Ag|Incremental Recovery (IR) at the maximum plasma concentration of von Willebrand Factor Antigen (VWF:Ag) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||(U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
693879|NCT01410227|Secondary|PK50 - Clearance of VWF:Ag|Clearance (CL) of von Willebrand Factor Antigen (VWF:Ag) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||dL/kg/hours||95% Confidence Interval|Median
693880|NCT01410227|Secondary|PK50 - Mean Residence Time of VWF:Ag|Mean Residence Time (MRT) of von Willebrand Factor Antigen (VWF:Ag) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII] or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||hours||95% Confidence Interval|Median
693881|NCT01410227|Secondary|PK50 - Area Under the Plasma Concentration/Time Curve From Time 0 to 96 Hours (AUC0-96h/Dose) of VWF:Ag|Area under the plasma concentration curve (AUC) from time 0 to 96 hours of von Willebrand Factor Antigen (VWF:Ag) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout|||(hours*U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
693882|NCT01410227|Secondary|PK50 - Area Under the Plasma Concentration/Time Curve From Time 0 to Infinity (AUC0-∞/Dose) of VWF:Ag|Area under the plasma concentration curve (AUC) from time 0 to infinity of von Willebrand Factor Antigen (VWF:Ag) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||(hours*U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
693883|NCT01410227|Secondary|PK50 - Volume of Distribution at Steady State of VWF:RCo|Volume of Distribution at Steady State (Vss) of von Willebrand Factor Ristocetin cofactor (VWF:RCo) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||dL/kg||95% Confidence Interval|Median
693946|NCT01409239|Primary|Difference Between Heart Rate Variability Between Intravenous and Subcutaneous Group|difference in mean low frequency/high frequency heart rate variability (LF/HF HRV)at 6 hour. 2 patients were excluded who did not have usable LF/HF HRV data at 6 hours. These patients remained in the study as they did have other measures.|6 hour|||none (ratio)||Inter-Quartile Range|Median
693884|NCT01410227|Secondary|PK50 - Elimination Phase Half-Life of VWF:Co|Elimination Phase Half-Life (T1/2) of von Willebrand Factor Ristocetin cofactor (VWF:RCo) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant FVIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||hours||95% Confidence Interval|Median
693885|NCT01410227|Secondary|PK50 - Incremental Recovery of VWF:RCo|Incremental Recovery (IR) at the maximum plasma concentration of von Willebrand Factor Ristocetin cofactor (VWF:RCo) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||(U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
693886|NCT01410227|Secondary|PK50 - Clearance of VWF:RCo|Clearance (CL) of von Willebrand Factor Ristocetin cofactor (VWF:RCo) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||dL/kg/hours||95% Confidence Interval|Median
693887|NCT01410227|Secondary|PK50 - Mean Residence Time of VWF:RCo|Mean Residence Time (MRT) of von Willebrand Factor Ristocetin cofactor (VWF:RCo) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||hours||95% Confidence Interval|Median
693888|NCT01410227|Secondary|PK50 - Area Under the Plasma Concentration/Time Curve From Time 0 to 96 Hours (AUC0-96h/Dose) of VWF:RCo|Area under the plasma concentration curve (AUC) from time 0 to 96 hours of von Willebrand Factor Ristocetin cofactor (VWF:RCo) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||(hours*U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
693889|NCT01410227|Secondary|PK50 - Area Under the Plasma Concentration/Time Curve From Time 0 to Infinity (AUC0-∞/Dose) of VWF:RCo|Area under the plasma concentration curve (AUC) from time 0 to infinity of von Willebrand Factor Ristocetin cofactor (VWF:RCo) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for subjects in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||(hours*U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
693890|NCT01410227|Secondary|Number of Adverse Events by Infusion Related to Study Product Including Clinically Significant Changes in Laboratory Parameters and Vital Signs|Adverse Events (AEs) by infusion related to study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) are described. Only laboratory parameters (hematology and clinical chemistry) and vital signs (physical examination, ECG) with clinically significant findings that are recorded as AEs are included. Categories presented as Severity-System Organ Class-Preferred Term Seriousness: serious adverse event (SAE); non serious adverse event (nsAE) System Organ Class: Cardiac disorders (CARD); General disorders and administration site conditions (GEN); Investigations (INV); Nervous system disorders (NERV); Skin and subcutaneous tissue disorders (SKN); Vascular disorders (VAS).|For 12 months after first infusion of rVWF:rFVIII or rVWF|||Number of Adverse Events|Participants||Number
693891|NCT01410227|Secondary|Number of Participants With Adverse Events Related to Study Product Including Clinically Significant Changes in Laboratory Parameters and Vital Signs|Number of participants with Adverse Events (AEs) related to study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) are described. Only laboratory parameters (hematology and clinical chemistry) and vital signs (physical examination, ECG) with clinically significant findings that are recorded as AEs are included. Categories presented as Severity-System Organ Class-Preferred Term Seriousness: serious adverse event (SAE); non serious adverse event (nsAE) System Organ Class: Cardiac disorders (CARD); General disorders and administration site conditions (GEN); Investigations (INV); Nervous system disorders (NERV); Skin and subcutaneous tissue disorders (SKN); Vascular disorders (VAS).|For 12 months after first infusion of rVWF:rFVIII or rVWF|||Number of participants|||Number
693892|NCT01410227|Secondary|Number of Adverse Events Related to Study Product Including Clinically Significant Changes in Laboratory Parameters and Vital Signs|Adverse Events (AEs) related to study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) are described. Only laboratory parameters (hematology and clinical chemistry) and vital signs (physical examination, ECG) with clinically significant findings that are recorded as AEs are included. Categories presented as Severity-System Organ Class-Preferred Term Seriousness: serious adverse event (SAE); non serious adverse event (nsAE) System Organ Class: Cardiac disorders (CARD); General disorders and administration site conditions (GEN); Investigations (INV); Nervous system disorders (NERV); Skin and subcutaneous tissue disorders (SKN); Vascular disorders (VAS). Category title includes number of AEs [N] for the category.|For 12 months after first infusion of rVWF:rFVIII or rVWF|||Number of Adverse Events|Participants||Number
693893|NCT01410227|Secondary|Percentage of Participants Who Had an Occurrence of Thrombotic Events||After signing informed consent until 12 months after first infusion of rVWF:rFVIII or rVWF|||Percent of participants|||Number
693894|NCT01410227|Secondary|Percentage of Participants Who Develop Binding Antibodies to Mouse Immunoglobulin|The presence of total binding anti-Murine immunoglobulin (IgG) antibodies was determined using an enzyme-linked immunosorbent assay (ELISA). Category title includes number of participants [N] who provided data for the category.|After signing informed consent until 12 months after first infusion of rVWF:rFVIII or rVWF|||Percent of participants|||Number
693895|NCT01410227|Secondary|Percentage of Participants Who Develop Binding Antibodies to rFurin|The presence of total binding anti-rFurin antibodies was determined by measuring total immunoglobulin (Ig) antibodies (IgG, IgA, IgM) against rFurin protein using an enzyme-linked immunosorbent assay (ELISA). Category title includes number of participants [N] who provided data for the category.|After signing informed consent until 12 months after first infusion of rVWF:rFVIII or rVWF|||Percent of participants|||Number
693896|NCT01410227|Secondary|Percentage of Participants Who Develop Binding Antibodies to CHO|The presence of total binding anti-CHO antibodies was determined by measuring total immunoglobulin (Ig) antibodies (IgG, IgA, IgM) against Chinese Hamster Ovary (CHO) protein using an enzyme-linked immunosorbent assay (ELISA). Category title includes number of participants [N] who provided data for the category.|After signing informed consent until 12 months after first infusion of rVWF:rFVIII or rVWF|||Percent of participants|||Number
693897|NCT01410227|Secondary|Percentage of Participants Who Develop Binding Antibodies to VWF|The presence of total binding anti-VWF antibodies was determined by an enzyme-linked immunosorbent assay (ELISA) employing polyclonal anti-human immunoglobulin (Ig) antibodies (IgG, IgM and IgA). Category title includes number of participants [N] who provided data for the category.|After signing informed consent until 12 months after first infusion of rVWF:rFVIII or rVWF|||Percent of participants|||Number
693898|NCT01410227|Secondary|Percentage of Participants Who Develop Inhibitory Antibodies to VWF|Neutralizing antibodies (inhibitors) to Von Willebrand Factor Ristocetin cofactor (VWF:RCo), VWF collagen binding (VWF:CB) and VWF Factor VIII binding (VWF:FVIIIB) activities were measured using Nijmegen modification of the Bethesda assay. One Bethesda Unit (BU) is thereby defined as the amount of inhibitor that decreased the measured activity in the assays to 50% of that of the negative control samples. The assays were validated using human plasma samples from two type 3 VWD patients with low (1-2 BU/mL) and high (~10 BU/mL) titer inhibitors and plasma samples from non-human primates immunized with human rVWF (>100 BU/mL). Category title includes number of participants [N] who provided data for the category.|After signing informed consent until 12 months after first infusion of rVWF:rFVIII or rVWF|||Percent of participants|||Number
693899|NCT01410227|Secondary|Percentage of Participants Who Develop Inhibitory Antibodies to FVIII|Development of neutralizing antibodies (inhibitors) to factor VIII (FVIII) was assessed by the Nijmegen modification of the Bethesda assay. Positive FVIII inhibitor tests were defined as ≥ 0.4 Bethesda units/mL (BU/mL) by the Nijmegen-modified Bethesda assay that is confirmed by a second test performed on an independent sample obtained 2-4 weeks following the first test. Category title includes number of participants [N] who provided data for the category.|For 12 months after first infusion of rVWF:rFVIII or rVWF|||Percent of participants|||Number
693900|NCT01410227|Secondary|Number of Units of rVWF:rFVIII and/or rVWF Per Bleeding Episode|The number of units is provided as the actual dose [IU/kg] of recombinant von Willebrand factor:recombinant factor VIII (rVWF:rFVIII) and/or rVWF required to treat a bleeding episode (BE). BEs were to be initially treated with an infusion of rVWF:rFVIII and subsequently with rVWF with or without rFVIII, based on FVIII levels, if available. In cases, where no FVIII levels were available, the individual participant’s PK data was used to determine the rFVIII dose. The data set included prospectively estimated BEs treated with study product of known lot number with an available efficacy rating from participants in the Full Analysis Set.|For 12 months after first infusion of rVWF:rFVIII or rVWF|||IU/kg|Participants|90% Confidence Interval|Median
693901|NCT01410227|Secondary|Number of Infusions of rVWF:rFVIII and/or rVWF Per Bleeding Episode|The actual number of infusions of recombinant von Willebrand factor:recombinant factor VIII (rVWF:rFVIII) and/or rVWF required to treat a bleeding episode (BE). BEs were to be initially treated with an infusion of rVWF:rFVIII and subsequently with rVWF with or without rFVIII, based on FVIII levels, if available. In cases, where no FVIII levels were available, the individual participant's PK data was used to determine the rFVIII dose. The data set included prospectively estimated BEs treated with study product with an available efficacy rating from participants in the Full Analysis Set.|For 12 months after first infusion of rVWF:rFVIII or rVWF|||Number of infusions|Participants|90% Confidence Interval|Median
693902|NCT01410227|Secondary|"Percentage of Treated Bleeding Episodes With an Efficacy Rating of Excellent or Good, Excluding Gastrointestinal Bleeds"|"Efficacy ratings of excellent or good for the control of bleeding episodes (BEs) with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) are defined as follows: Excellent - actual infusions ≤ estimated number of infusions required to treat BE; no additional von Willebrand Factor (VWF) required (all BEs); Good - >1-2 infusions (minor/moderate BEs) or <1.5 infusions (major BEs) greater than estimated required to control BE; no additional VWF required (all BEs). The data set included prospectively estimated BEs excluding gastrointestinal (GI) bleeds treated with study product with an available efficacy rating from participants in the Full Analysis Set."|For 12 months after first infusion of rVWF:rFVIII or rVWF|||Percent of bleeding episodes|Participants|90% Confidence Interval|Geometric Mean
699996|NCT00033371|Secondary|Change in Global Colorectal Polyp Burden|The two-sample t-test or its non-parametric analogue, the Wilcoxon rank sums test will be used.|Baseline up to 2 months after completion of study treatment||||||
693903|NCT01410227|Secondary|"Percentage of Treated Bleeding Episodes With an Efficacy Rating of Excellent or Good"|"Efficacy ratings excellent or good for the control of bleeding episodes (BEs) with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) are defined as follows: Excellent - actual infusions ≤ estimated number of infusions required to treat BE; no additional von Willebrand Factor (VWF) required (all BEs); Good - >1-2 infusions (minor/moderate BEs) or <1.5 infusions (major BEs) greater than estimated required to control BE; no additional VWF required (all BEs). The data set included prospectively estimated BEs treated with study product with an available efficacy rating from participants in the Full Analysis Set"|For 12 months after first infusion of rVWF:rFVIII or rVWF|||Percent of bleeding episodes|Participants|90% Confidence Interval|Number
693904|NCT01410227|Primary|Percentage of Participants With Treatment Success for Treated Bleeding Episodes|Treatment success was defined as the extent of control of bleeding episodes (BEs) using a mean efficacy rating score of <2.5 for a participant’s BEs treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) during the study period. Scores used: Excellent = 1 - actual infusions ≤ estimated number of infusions required to treat BE; no additional VWF required (all BEs); Good = 2 - >1-2 infusions (minor/moderate BEs) or <1.5 infusions (major BEs) greater than estimated required to control BE; no additional VWF required (all BEs); Moderate = 3 ≥ 3 infusions (minor/moderate BEs) or ≥ 1.5 infusions (major BEs) greater than estimated required to control BE; no additional VWF required (all BEs); None = 4 - severe uncontrolled bleeding or intensity of bleeding not changed; additional VWF required. Included participants with available primary efficacy rating (prospective-excluding gastrointestinal bleeds) in the Full Analysis Set.|For 12 months after first infusion of rVWF:rFVIII or rVWF|||Percent of participants||90% Confidence Interval|Number
693905|NCT01410110|Secondary|Global Index|Comprised of the average of 5 Index T Scores (Attention, Processing Speed, Visual and Verbal Memory and Learning, Working Memory and Executive Function). T Scores range from 30 to 80 with a mean of 50. Higher scores are better.|Baseline, 3 Months, 6 Months|||T Scores||Standard Deviation|Mean
693906|NCT01410110|Secondary|Executive Function|Mazes, Wisconsin Card Sorting Task (WCST) Perseverative Error, Non-Perseverative Error, Conceptual Level. T Scores for each variable were averaged together. T Scores have a range of 30 to 80 with a mean of 50. Higher scores are better.|Baseline, 3 Months, 6 Months|||T Scores||Standard Deviation|Mean
693907|NCT01410110|Secondary|Verbal and Visual Working Memory|WAIS Digit Span and Wechsler Memory Scale (WMS) Spatial Span. T Scores are averaged. T Scores range from 30 to 80 with a mean of 50. Higher scores are better.|Baseline, 3 Month, 6 Months|||T Scores||Standard Deviation|Mean
693908|NCT01410110|Secondary|Verbal and Visual Learning and Memory|Brief Visual-Spatial Memory Test (BVMT) and Hopkins Verbal Learning and Memory Test (HVLT). Total Score T Scores for tests were averaged. T score range is 30 to 80 with a mean of 50. Higher scores are better.|Baseline, 3 Months, 6 Months|||T Scores||Standard Deviation|Mean
693909|NCT01410110|Secondary|Processing Speed Index|Wechsler Adult Intelligence Scale (WAIS) Digit Coding and Symbol Search. T scores for the assessments are averaged. T scores range from 30 to 80 with a mean of 50. Higher scores are better.|Baseline, 3 Months, 6 Months|||T Scores||Standard Deviation|Mean
693910|NCT01410110|Primary|Weeks of Sobriety|0 to 26 Weeks. Higher number of Weeks is better.|26 weeks|1 additional participant in Work Therapy Only had missing data for this variable.||Weeks||Standard Deviation|Mean
693911|NCT01410110|Primary|Days of Use in Prior 30 Days|Days of Use based on Time-Line Follow-back, Toxicology Screen, Breathalyzer, and Chart Review. The range at 6 month follow-up is 0 to 30 days of use with more days being a worse outcome.|30 Days Prior to 6 month follow-up|||Days of Use||Standard Deviation|Mean
693912|NCT01410110|Secondary|Attention Index|Index comprised on Trails A and Continuous Performance Test. T scores for the assessments are averaged. T scores range from 30 to 80 with a mean of 50. Higher scores are better.|Baseline, 3 month and 6 month follow-up|||T Scores||Standard Deviation|Mean
693913|NCT01410110|Primary|Days of Sobriety in First 90 Days|Abstinence will be determined by toxicology screening, breathalyzer and substance abuse calendar weekly during 3 months of active intervention. Days of sobriety has a range of 0 to 90 with higher being a better outcome.|3 months|||Days of Sobriety||Standard Deviation|Mean
693914|NCT01409993|Secondary|Blood Pressure|Systolic blood pressure|3 months|||mmHg||Standard Deviation|Mean
693915|NCT01409993|Secondary|Fasting Plasma Glucose||3 months|||mg/dL||Standard Deviation|Mean
693916|NCT01409993|Primary|Glucose Infusion Rate|In the group of subjects undergoing euglycemic clamp (Aim 2)|2.5 hours after 3 months of therapy|one subject in the sildenafil Aim 2 arm has incomplete data from the three-month clamp due to infusion dysfunction||mL/hr||Standard Deviation|Mean
693917|NCT01409993|Primary|Index of Tissue Sensitivity to Insulin|in the group of subjects undergoing hyperglycemic clamp (Aim 1), calculated by dividing the average glucose infusion rate during the last hour of the clamp by the average plasma insulin concentration during the same interval|2.5 hours after 3 months of therapy|||(mg/kg/min per microU/mL)*100||Standard Error|Mean
693918|NCT01409993|Primary|Insulin Secretion|in the group of subjects undergoing hyperglycemic clamp (Aim 1)|2.5 hours after 3 months of therapy|Glucose-stimulated insulin secretion from 90 to 120 minutes of hyperglycemic clamp||microU/mL||Standard Error|Mean
693919|NCT01409837|Primary|Proportion of Sperm Cells With Abnormal Morphology (%)|The proportion (per cent) of the total number of sperm cell with abnormal appearance.|Week 282|All the patients who were randomized into each group were analyzed on the basis of intention-to-treat.||Per cent||Standard Deviation|Geometric Mean
693920|NCT01409837|Primary|Proportion of Sperm Cells With Normal Motility (%)|The proportion (per cent) of the sperm cells exhibiting both rhythmic and propulsive movements considered to be of normal intensity.|Week 282|All the patients who were randomized into each group were analyzed on the basis of intention-to-treat||Per cent||Standard Deviation|Geometric Mean
693921|NCT01409837|Primary|Total Sperm Cell Count|The total number of sperm cells found in each milliliter of seminal fluid.|Week 282|All the patients who were randomized into each group were analyzed on the basis of intention-to-treat.||Millions/ml||Standard Deviation|Geometric Mean
693922|NCT01409837|Primary|Ejaculate Volume|The volume in milliliters of seminal fluid produced per ejaculation.|Week 282|All the patients who were randomized into eacg group was analyzed on the basis of intention-to-treat||ml||Standard Deviation|Geometric Mean
704782|NCT00100932|Secondary|Overall Survival|Defined as the time from the start of study medication until death from any cause.|From time of start of study medication until death||||||
693926|NCT01409837|Secondary|Adverse Events Monitoring|The patients were encouraged to report every event promptly by phone to one of the authors (NOG), no matter however minor.Blood pressure measurements were done with mercury sphygmomanometers fitted with adult-size cuffs (Accoson, England). Serum potassium levels were estimated using the flame photometric method as described by Davidson and Henry|At weeks 6, 12, 24, 48, 96, 102, 114,138, 186 and 282|All the patients who were randomized into each group were monitored for adverse events.||participants|||Number
693927|NCT01409837|Primary|Changes From Baseline in the Seminal Fluid Characteristics Throughout the Study|The seminal fluid characteristics were assessed twice before the entry of each patient and both at least two-weeks apart. The two values were averaged and recorded as baseline for week 0 while subsequent changes from the baseline were monitored during each of the scheduled visits at weeks 6, 12, 24, 48, 96, 102, 114, 138, 186 and 282. The two groups swopped treatments at the 96th week. The number of pregnancies achieved was also documented throughout the study period.|Week 96.|All the patients randomized into each group were included in the analysis on the basis of intention-to-treat (last value carried forward)||ml||Standard Deviation|Geometric Mean
693928|NCT01409707|Primary|Timeline Follow Back|The timeline follow back is a measure of drug and alcohol consumption in the prior 90 days. The timeline follow back is a calendar-based retrospective account of drug and alcohol consumption for a specified period of time (e.g., past 90 days). One of the most commonly reported metrics of drug and alcohol consumption from this measure is percent days abstinent (PDA). Percent days abstinent is simply the proportion of days for the specified period of time (e.g., 90 days) in which drugs or alcohol were not consumed. Percent days abstinent can range from 0 to 100 with 0 representing no abstinence during a specified period of time (i.e., consumed alcohol every day) and 100 representing complete abstinence during a specified period of time.|3-months posttreatment|All participants who started the study were included in the analyses (ITT). Missing data were estimated using maximum likelihood estimation.||percentage of days abstinent||Standard Error|Mean
693929|NCT01409707|Primary|Impact of Event Scale-Revised|The Impact of Event Scale-Revised is a 22-item self-report measure of posttraumatic stress disorder symptoms. The total score for the Impact of Event Scale-Revised ranges from 0 to 88 with lower scores representing less severe symptoms of posttraumatic stress disorder and higher scores representing more severe symptoms of posttraumatic stress disorder.|3-months posttreatment|All participants who started the study were included in the analyses (ITT). Missing data were estimated using maximum likelihood estimation.||units on a scale||Standard Error|Mean
693930|NCT01409564|Secondary|Fazekas Scale|"Level of severity of white matter lesions in AD patients who can be legitimately administered with cilostazol. Measured by professionally trained clinicians.
The higher score indicates more severe white matter lesion. Max-min: 0-3"|Baseline|||participants|||Number
693931|NCT01409564|Secondary|Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB)|"Measured by professionally trained clinicians. Higher score indicates more severe AD symptoms.
Score Scale: 0-18 (min-MAX)"|Baseline, 12-month, 24-month|||units on a scale||Standard Deviation|Mean
693932|NCT01409564|Secondary|Activities of Daily Living (ADCS-ADL)|"The caregiver answered to the questions given to measure the cognitive function level of the patients in daily living. Lower scores indicate greater severity.
23 questions Score Scale: 0-78 (min-MAX)"|Baseline, 12-month, 24-month|||units on a scale||Standard Deviation|Mean
693933|NCT01409564|Secondary|Mini-Mental State Examination (MMSE) in the Korean Version of the CERAD Assessment Packet)|Basic cognitive functions are checked. (0-30) The score is better when higher.|Baseline, 12-month, 24-month|||units on a scale||Standard Deviation|Mean
693934|NCT01409564|Secondary|Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-cog)|"The ADAS-Cog score is measured by the number of questions answered incorrectly, therefore the higher is the worse.
Score Scale: 0-75 (min-MAX)
Each subcategory scores are summed.
Word-recall test (0-10)
Commands (0-5)
Constructional praxis (0-5)
Naming Objects/ Fingers (0-5)
Ideational Praxis (0-5)
Orientation (0-8)
Word Recognition (0-12)
Remembering Test Instructions (0-5)
Spoken Language Ability (0-5)
Word Finding Difficulty (0-5)
Comprehension (0-5)"|Baseline, 12-week, 24-week|||units on a scale||Standard Deviation|Mean
693935|NCT01409564|Primary|Regionally Averaged Cerebral Glucose Uptake Changes Measured by FDG PET Uptake With Voxel-based Method|Regional cerebral glucose uptake level was measured as the ratio value of FDG uptake of the each unit level to the global mean uptake value.|Baseline, 24-week|Number of patients with increased whole brain glucose uptake level. In the real analysis, however, a voxel-based image analysis results were used; therefore, data which can be entered here is not much meaningful.||Bq/Bq (no unit)||Standard Deviation|Mean
693936|NCT01409434|Secondary|High Density Lipoprotein (mg/dL)||High Density Lipoprotein was obtained at time 0 min.|||mg/dL||Standard Deviation|Mean
693937|NCT01409434|Secondary|Low Density Lipoprotein (mg/dL)||Low Density Lipoprotein was obtained at time 0 min.|||mg/dL||Standard Deviation|Mean
693938|NCT01409434|Secondary|Triglycerides (mg/dL)||Triglycerides was obtained at time 0 min.|||mg/dl||Standard Deviation|Mean
693939|NCT01409434|Secondary|Oral Glucose Tolerance Test (mg/dl h)|Area under the curve for the OGTT was calculated for each patient using the 3 time points (0 hour, 1 hour and 2 hour). Average value for participants is provided.|one oral glucose tolerance test was performed with 3 time points (0 hour, 1 hour, 2 hour)|Patients that underwent an OGTT||mg/dL*h||Standard Deviation|Mean
693940|NCT01409434|Primary|Fasting Glucose (mg/dL)||Fasting glucose was obtained at time 0 min.|A total of 44 patients were included in the study, however 4 patients were treated with anti-diabetic medications and so were excluded from the analysis. Therefore there are a total of 40 patients that were included in the analysis.||mg/dL||Standard Deviation|Mean
693941|NCT01409382|Other Pre-specified|Pregnancy and Neonatal Outcomes|Early miscarriages, 2nd and 3rd trimester losses, preterm deliveries, take-home babies, neonatal hypoglycemia: number of babies|Three years|||participants (babies)|||Number
693942|NCT01409382|Secondary|Refractory Hypoglycemia|"Any glucose level ≤ 40/dL at 1, 2 or 4 h:
Neonates with hypoglycemia (glucose level equal or below 40 mg/dL at 1, 2 or 4 h) will be offered milk. Neonates unable to suckle, will be treated with intravenous dextrose for one hour.
A new heel stick blood sample will be drawn to assess glucose levels.
Neonates with persistent hypoglycemia will be considered as refractory hypoglycemia."|One hour after feeding or after intravenous dextrose|All hypoglycemic neonates were screened for refractory hypoglycemia. Only neonates born to mothers who were physically inactive and reported excessive carbohydrate consumption displayed refractory hypoglycemia.||neonates with refractory hypoglycemia|||Number
693948|NCT01409213|Primary|Change From Baseline for Mean Hemoglobin A1c (HbA1C)|Change from baseline was defined as mean HbA1c baseline value minus the mean HbA1c end of observation value.|Baseline and end of Observation (up to Month 6)|Participants from the full analysis set with available data.||Percent of glycosylated hemoglobin||Standard Deviation|Mean
693953|NCT01408992|Primary|Standard Hearing Test|Hearing loss is defined as an elevation, at least more than 25 dB of air-conduction, pure tone average threshold at speech frequencies. The severity loss is categorized into mild (26-40 dB), moderate (41-55 dB), moderately severe (56-74 dB), severe (75-90 dB), and profound (>90 dB). In this study, we aim to use FMHT as a screening tool for hearing disability (Better hearing ear has hearing threshold greater than 40 dB).|Baseline|||participants|||Number
693954|NCT01408992|Post-Hoc|Sensitivity of FMHT to Detect the Hearing Loss.|"FMHT has 15 questions and there are 4 possible answer for each question. The best possible answer is never and is scored 0, occasionally is scored 1, half the time is scored 2 and almost always the worst answer is scored 3. The total possible range for the FMHT scores 0-45. We then compared the total score with the better hearing ears as in Outcome measure 1. The total number of participants with a score from 0 to 45, and that all participants in the study had a score within this range. It would appear, from information provided in the previous version of this record, that the total score might range from 0 to 45."|baseline|The frequencies of subjects who had FMHT score from 0 to 45 were counted.||participants|||Number
693955|NCT01408992|Secondary|Prevalence of Ear Diseases|the frequency of diseased ears per the total examined ears|Immediate|||ears|Participants||Number
693956|NCT01408914|Secondary|Incidence of Rifampin-related Grade 2 or Higher Adverse Events|Number of participants experiencing at least one rifampin-related grade 2 or higher adverse events during the initial 8 weeks of treatment and up to four weeks after.|Throughout the 12 weeks post treatment initiation|||Participants|||Count of Participants
693957|NCT01408914|Secondary|Difference in Frequency of Sputum Culture Sterilization During the Initial 8 Weeks of Treatment|Number of participants that are sputum culture (in LJ) negative for TB at 8 weeks|Until 8 weeks of treatment are completed|||Participants|||Count of Participants
693958|NCT01408914|Primary|Steady State Pharmacokinetic Exposure of RIF|AUC0-6/MIC across treatment arms.|At any time during the intensive phase of treatment, after steady state has been reached (at a minimum, after 14 days of daily RIF delivery)|Analysis was completed in 168 participants evaluable for pharmacokinetics, as samples were unable to be collected in 12 study participants.||AUC0-6 (h*mcg/mL) / MIC99.9 (mcg/mL)||Inter-Quartile Range|Median
693959|NCT01408888|Secondary|Pharmacokinetics: Time of Maximum Observed Drug Concentration (Tmax) of LY2189265||Predose and up to 168 hours postdose on Day 1 of Treatment 1 and on Day 5 and Day 12 of Treatment 2|Participants who received at least one dose of LY2189265 with evaluable LY2189265 tmax data.||hours||Full Range|Median
693960|NCT01408888|Secondary|Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of LY2189265||Predose and up to 168 hours postdose on Day 1 of Treatment 1 and on Day 5 and Day 12 of Treatment 2|Participants who received at least one dose of LY2189265 with evaluable LY2189265 Cmax data.||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
693961|NCT01408888|Secondary|Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of LY2189265|Area under the LY2189265 pharmacokinetic (PK) concentration versus time curve (AUC [0-tau]) during one dosing interval (168 hours) is summarized.|Predose and up to 168 hours postdose on Day 1 of Treatment 1 and on Day 5 and Day 12 of Treatment 2|Participants who received at least one dose of LY2189265 with evaluable LY2189265 AUC data.||nanograms times hour/milliliter(ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
693962|NCT01408888|Secondary|Pharmacokinetics: Time of Maximum Observed Drug Concentration (Tmax) of Sitagliptin||Predose and up to 24 hours post dose on Day 4, Day 6, and Day 13 of Treatment 2|Participants who received at least one dose of sitagliptin with evaluable sitagliptin tmax data||hours||Full Range|Median
693963|NCT01408888|Primary|Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of Sitagliptin||Predose and up to 24 hours postdose on Day 4, Day 6, and Day 13 of Treatment 2|Participants who received at least one dose of sitagliptin with evaluable sitagliptin Cmax data.||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
693964|NCT01408888|Primary|Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of Sitagliptin|Area under the sitagliptin pharmacokinetic (PK) concentration versus time curve (AUC [0-tau]) during one dosing interval (24 hours) is summarized.|Predose and up to 24 hours postdose on Day 4, Day 6, and Day 13 of Treatment 2|Participants who received at least one dose of sitagliptin with evaluable sitagliptin AUC data.||nanograms times hour/milliliter(ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
694015|NCT01407276|Primary|Maximum Concentration (Cmax) of Omarigliptin|Cmax is a measure of the maximum amount of drug in the plasma after the dose is given.|Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 (Panel G only), 96, 168, 240, and 336 hours post-dose|All participants that received a single 3 mg dose of omarigliptin.||nM||95% Confidence Interval|Geometric Mean
706384|NCT00114972|Primary|Repeat Revascularization (PCI and/or CABG).|Number of participants with repeat revascularization (PCI and/or CABG).|12 Months post enrollment|||Participants|||Number
693965|NCT01408862|Primary|Changes in Basal or Aggregant-induced Platelet Activation (With and Without Glucose Added to the Media, 200 mg/dl, 400 mg/dL) by GLP-1-(7-36)NH2 and Its Metabolite (GLP-1-(9-36)NH2)and a GIP Agonist at Different Concentrations.|"1 Direct effect of GLP-1-(7-36)NH2 and its metabolite (GLP-1-(9-36)NH2) and GIP agonist on platelet aggregation, with and without preincubation at different glucose concentrations.
2. GLP-1-(7-36)NH2 and its metabolite (GLP-1-(9-36)NH2) and GIP agonist modulation (with and without 300 mg/dL glucose added to the media) of platelet activation and aggregation induced by classical platelet agonists such as ADP, collagen and bovine von Willebrand factor.
Data points from various conditions were combined (averaged),"|Platelets drawn from a volunteer will be evaluated 1 time (in 1-2 days)|We assume that with 10 samples per condition divided in 5 categories (1 control plus 4 concentrations of GLP1 and GIP agonists) for a standardized difference of 0.5 between groups and a p=0.05, the statistical power would be higher than 90%. We used a similar design to test the effect of GLP1 and GIP agonists on platelet aggregants.||% of Inhibition||Standard Deviation|Mean
693966|NCT01408862|Primary|Expression of Glucagon Like Peptide -1 (GLP-1) and Gastric Inhibitory Peptide (GIP) Receptors in Normal Human Platelets|1.1 Measurement of GLP-1 and GIP receptors at the platelet RNA level by Real Time-PCR 1.2 GLP-1 and GIP receptors detection at the protein level: 1.2.1 Expression on platelet membrane by flow cytometry. 1.2.2 Detection in total platelet proteins by western-blot. Data of flow cytometry are provided below|Platelets drawn from a volunteer were evaluated 1 time (in 1-2 days)|||percentage of positive cells||Standard Deviation|Mean
693967|NCT01408719|Secondary|Changes in Body Weight and Waist Circumference(WC)|Body weight will be monitored every day when subject visits the Richardson Centre. Waist circumference will be measured at the beginning and end of each study phase.|Every day for body weight; beginning and end of each phase for WC||||||
693968|NCT01408719|Primary|Changes in LDL Cholesterol|Serum LDL cholesterol will be estimated using the Friedewald equation.|Beginning and end of each phase||||||
693969|NCT01408719|Secondary|Potential Gene-nutrient Interactions: CYP7A1 and APOE|The Single Nucleotide Polymorphism (SNP) rs3808607 of CYP7A1 gene, rs429358 and rs7412 of APOE gene, and their associations with different blood lipid responses to beta-glucan interventions will be determined.|Once for each participant||||||
693970|NCT01408719|Secondary|Cholesterol Absorption/Synthesis|The rate of cholesterol absorption and synthesis will be measured in each intervention phase using single stable isotope labelling technique.|End of each phase||||||
693971|NCT01408719|Primary|Changs in Total Cholesterol|Fasted total cholesterol concentration will be measured using the automated enzymatic methods.|Beginning and end of each phase|||mmol/L||Standard Error|Least Squares Mean
693972|NCT01408706|Secondary|Patient Expression of Discomfort|Patient expression of discomfort was scored for each insertion by the treating radiation therapist on a scale from 1(none) to 5(intolerable). An average score was obtained at completion of therapy for each patient. At completion of the study, an average value was obtained for each immobilization device by averaging the average score for each patient .|Up to nine weeks|||units on a scale||Full Range|Mean
693973|NCT01408706|Secondary|Difficulty of Insertion.|Difficulty of device insertion was scored for each treatment by the treating radiation therapist on a scale from 1(easiest) to 5(most difficult). An average score was obtained at completion of therapy for each patient. At completion of the study, an average value was obtained for each immobilization device by averaging the average score for each patient .|Up to nine weeks|||units on a scale||Full Range|Mean
693974|NCT01408706|Primary|Deviation of the Prostate Rectal Interface From Its Position at Time of Simulation.|Measurements will be taken for at least 5, and up to 9, occasions on a weekly basis during each patient's course of treatment. An average value will be determined for each patient. An average of individual patient values will be determined for each immobilization device.|Up to 9 weeks|||CENTIMETERS||Standard Deviation|Mean
693975|NCT01408628|Secondary|Severity of Self-reported Hypoglycemia|Severity was defined by the scale used by the DCCT: grade 1 - subject was able to recognize and treat appropriately without assistance; grade 2 - subject required help from another person either to recognize or recognize/treat; grade 3 - subject required injection of glucagon or treatment in ER|6 Months|Subjects who completed both the Internet intervention and the 6 months of follow up||incidents (count)|||Number
693976|NCT01408628|Secondary|Change in HbA1c|Change in HbA1c (average measure of the % of glycosolated hemoglobin in the blood over the past 3 months) from baseline to end of follow up period.|Change from Baseline through Month 6 of follow-up period|Subjects who both completed the Internet intervention and the six months of follow up||percentage of glycosolated hemoglobin||Standard Deviation|Mean
693977|NCT01408628|Primary|Frequency of Hypoglycemia|Hypoglycemia was defined in the study as either a blood glucose reading <70 mg/dL or symptomatic to the patient/subject.|6-month follow up period following the Internet Intervention|Subjects who both completed the Internet intervention AND the 6 months of follow up||incidents per person-year||Standard Deviation|Mean
693978|NCT01408537|Secondary|Neutralizing Antibody Persistence One Year After the Primary Vaccination|To determine the neutralizing antibody persistence one year after the primary JEVAC vaccination.|1 year after primary vaccination|The analysis was excluded 5 subjects who had NT titer >10 on D0||participants|||Number
693979|NCT01408537|Secondary|Adverse Events of Vaccine|To determine the adverse events of JEVAC|7, 14, 28 days after each vaccination and throughout the study period for local, solicited systemic, unsolicited systemic and serious adverse events, respectively|Determined AEs by number of injections 152 injection for the first dose 151 injection for the second dose 145 injection for the third dose||events|Participants||Number
693980|NCT01408537|Secondary|Geometric Mean Titer of NT After Primary and Booster Vaccination|To determine the geometric mean titers (GMT) of neutralizing antibody of JEVAC 1 month after primary and then before and after booster vaccinations.|28 days after second vaccination, before and 28 days after booster vaccination with JEVAC|152 were enrolled, 1 withdrawn consent before second vaccine, 5 had NT >= 10 before first vaccine, 146 included in D28 after second vaccine. At 1 year, 3 received JE vaccine outside the study, 3 lost follow up, 140 included in before booster, At D28 after booster, 1 could not draw blood, 139 included in D28 after booster.||titer||95% Confidence Interval|Geometric Mean
694016|NCT01407276|Primary|Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞) of Omarigliptin|AUC0-∞ is a measure of the mean concentration levels of drug in the plasma after the dose.|Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 (Panel G only), 96, 168, 240, and 336 hours post-dose|All participants that received a single 3 mg dose of omarigliptin.||nM*hr||95% Confidence Interval|Geometric Mean
693981|NCT01408537|Primary|Seroconversion Rate After Primary Vaccination|To determine the seroconversion rate by using neutralizing antibody (NT) against JE virus (Beijing P3 strain) JE virus from <10 on before first vaccination To >= 10 at 28 days after second vaccination (primary vaccination). Those who have NT titer >=10 before first vaccination, will not be included in immunogenicity evaluation.|28 days after second dose of JEVAC|There were 152 enrolled subjects in the study. However, 5 subjects had NT titer >= 10 before first vaccination and one subject whom blood on 28days after second vaccination was not drawn due to withdrawn consent. Therefore, the number of subjects for the outcome measurement should be 146.||percentage of seroconversion|||Number
693982|NCT01408485|Secondary|Secondary Efficacy|Secondary efficacy or chronic success is defined as freedom from recurrence of typical atrial flutter 3 mos. post ablation. Flutter recurrence will be documented on an ECG. Repeat ablations, new antiarrhythmia medications or increase in the existing anti-arrhythmic medications during the 3 mos. post ablation are considered chronic failures.|3 months|||participants|||Number
693983|NCT01408485|Primary|Primary Efficacy|Primary efficacy or acute success is defined as achievement of bi-directional block in the cavo-tricuspid isthmus and non-inducibility of typical atrial flutter at least 30 minutes following the last RF ablation with the investigational system.|30 minutes|||participants|||Number
693984|NCT01408485|Primary|Primary Safety: Incidence of Composite, Serious Adverse Events Within 7 Days Post-Procedure|Primary safety is defined as the incidence of composite, serious adverse events within 7 days post-procedure, regardless of whether a determination can be made regarding device relatedness.|7 days|200 subjects who met Inc/Excl criteria were enrolled. 21 subjects were withdrawn prior to the use of the investigational device, thus, 179 were treated. 5 subjects had composite adverse events that were serious and occurred within 7 days of the ablation procedure. These events are part of the primary safety endpoint analysis per protocol.||participants|||Number
693985|NCT01408329|Primary|Plasma Glucose Concentration||Glucose measurements were made at baseline, 3, 6, & 10 weeks. Blood was collected consistently after a 10–12 h fast the morning after a CVAC session (except for baseline).|Those that completed the study||mg/dl||Standard Deviation|Mean
693986|NCT01408303|Primary|Serum Non-HDL Cholesterol|The primary endpoints are the differences in mean percent changes from baseline to end-of-treatment in non-HDL cholesterol between placebo and the 2g/day and 4g/day Epanova groups.|6 weeks|"The Intent-to-Treat (ITT) Population was comprised of all subjects who were randomized. In the event that randomized subjects terminated before treatment or had no post-treatment efficacy assessments, a modified ITT Population was implemented."||Percent change from baseline||95% Confidence Interval|Least Squares Mean
693987|NCT01408277|Primary|Mean Percent Change in Wound Area|Wound area was measured using the ARANZ Silhouette digital wound imaging and measurement device. The average percent (%) of change from baseline of the target wound area at the end of the 6-week treatment period and the end of the entire 12-week study period respectively, was calculated using a two-way ANCOVA model.|6 and 12 weeks|Primary analysis was based on the Intent-to-treat dataset which consisted of all subjects randomized to treatment.||percentage of change in wound area||Standard Error|Mean
693988|NCT01407575|Primary|Weight|Participant weight|6 weeks|||lbs||Standard Deviation|Mean
693989|NCT01407575|Primary|Heart Rate|Heart Rate (Beats per minute) 60-100 beats per minute is considered normal lower heart rate represent healthier outcome|6 weeks|||Beats per minute||Standard Deviation|Mean
693990|NCT01407575|Secondary|Positive and Negative Affect Scale|"Positive Affect Score: Scores can range from 10 – 50, with higher scores representing higher levels of positive affect.
Negative Affect Score: Scores can range from 10 – 50, with lower scores representing lower levels of negative affect."|6 weeks|reduced sample size verified. This was secondary to administrative error.||units on a scale||Standard Deviation|Mean
693991|NCT01407575|Secondary|Brief Symptom Inventory -- Anxiety Subscale|measure of anxiety Lower numbers indicate better outcome Theoretical Range 0-2.4|6 weeks|||units on a scale||Standard Deviation|Mean
693992|NCT01407575|Primary|UKU Side Effect Rating Scale|measure of side effects 46 items with scores of 0,1,2,3 possible. Theoretical range 0-138 Lower scores indicate fewer side effects|6 weeks|||units on a scale||Standard Deviation|Mean
693993|NCT01407575|Primary|Blood Pressure|Measure of systolic and diastolic blood pressure. 140/90 or lower is considered normal and indicates a better outcome.|6 weeks|||mm Hg||Standard Deviation|Mean
693994|NCT01407575|Primary|Montgomery Asberg Depression Rating Scale|measure of depression severity Theoretical Range 0-60 lower values represent better outcome|6 weeks|||units on a scale||Standard Deviation|Mean
693995|NCT01407523|Secondary|Partial (Type 1) Seizure Frequency Per Day Over the Evaluation Period|Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures.|During the Evaluation Period (Day 1 to Day 4)|Full Analysis Set (FAS). The FAS consisted of all subjects in the Safety Set (SS) with evaluable seizure frequency data over the Evaluation Period. All 16 subjects in the SS are included in the FAS.||Seizures per day||Inter-Quartile Range|Median
693996|NCT01407523|Secondary|Dose Normalized Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on Day 4|"Plasma sample for determination of Plasma trough concentration of Levetiracetam was taken prior to intravenous infusion of Levetiracetam in the morning of Day 4.
Plasma trough concentration (Ctrough) was normalized to a dose of 500 mg as follows:
Dose normalized Ctrough = Ctrough/last dose [mg] x 500 mg."|Day 4|Pharmacokinetic Per Protocol Set (PK-PPS). This was defined as a subset of the Safety Set (SS) and consisted of subjects who had at least 1 evaluable Levetiracetam plasma concentration after intravenous administration. All 16 subjects from the SS are included in the PK-PPS.||micrograms per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
693997|NCT01407523|Secondary|Dose Normalized Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on Day 1|"Plasma sample for determination of Plasma trough concentration of Levetiracetam was taken prior to intravenous infusion of Levetiracetam in the morning of Day 1.
Plasma trough concentration (Ctrough) was normalized to a dose of 500 mg as follows:
Dose normalized Ctrough = Ctrough/last dose [mg] x 500 mg."|Day 1|Pharmacokinetic Per Protocol Set (PK-PPS). This was defined as a subset of the Safety Set (SS) and consisted of subjects who had at least 1 evaluable Levetiracetam plasma concentration after intravenous administration. All 16 subjects from the SS are included in the PK-PPS.||micrograms per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
706385|NCT00114972|Secondary|Freedom From MACCE and Its Components at 3 Years Post-allocation||3 years post allocation||||||
693998|NCT01407523|Secondary|Observed Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on Day 4|Plasma sample for determination of Plasma trough concentration of Levetiracetam was taken prior to intravenous infusion of Levetiracetam in the morning of Day 4.|Day 4|Pharmacokinetic Per Protocol Set (PK-PPS). This was defined as a subset of the Safety Set (SS) and consisted of subjects who had at least 1 evaluable Levetiracetam plasma concentration after intravenous administration. All 16 subjects from the SS are included in the PK-PPS.||micrograms per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
693999|NCT01407523|Secondary|Observed Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on Day 1|Plasma sample for determination of Plasma trough concentration of Levetiracetam was taken prior to intravenous infusion of Levetiracetam in the morning of Day 1.|Day 1|Pharmacokinetic Per Protocol Set (PK-PPS). This was defined as a subset of the Safety Set (SS) and consisted of subjects who had at least 1 evaluable Levetiracetam plasma concentration after intravenous administration. All 16 subjects from the SS are included in the PK-PPS.||micrograms per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
694000|NCT01407523|Primary|Incidence of Treatment Emergent Serious Adverse Events During the Entire Study Period (up to 32 Days)|A Serious Adverse Event (SAE) is any untoward medical occurrence that results in death, is life-threatening, results in significant or persistent disability/incapacity, is a congenital anomaly/birth defect (including that occurring in a fetus), or is an important medical event that may jeopardize the subject or may require medical or surgical intervention.|During the entire Study Period from Screening (Day -14 to Day -1) over Evaluation Period (Day 1 to Day 4) to Follow-Up Period (Day 5 to Day 18)|Safety Set (SS)||participants|||Number
694001|NCT01407523|Primary|Incidence of Treatment Emergent Adverse Events During the Entire Study Period (up to 32 Days)|An Adverse Event (AE) is any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|During the entire Study Period from Screening (Day -14 to Day -1) over Evaluation Period (Day 1 to Day 4) to Follow-Up Period (Day 5 to Day 18)|Safety Set (SS)||participants|||Number
694002|NCT01407354|Secondary|Number of Movement Recorded by Activity Monitor (SAM)|SAM movements not just steps were gathered one time pre, crossover and post and worn on ankle for 5 days; percent change for each intervention|7 months|||number of movements||Standard Deviation|Mean
694003|NCT01407354|Primary|Number of Participants Demonstrating 10% Change: Arm Ergometer and Lokomat Metabolic Cart VO2 Peak|Peak VO2 via Arm Ergometer and Lokomat with metabolic cart|7 months|||participants|||Number
694004|NCT01407276|Secondary|Number of Participants Withdrawn From Study||Up to Day 15|All participants that received a single 3 mg dose of omarigliptin.||Participants|||Number
694005|NCT01407276|Secondary|Number of Participants Experiencing an Adverse Event (AE)|An AE was defined as any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a Sponsor product, whether or not considered related to the use of the product.|From pre-dose to 14 days post-dose (Up to Day 15)|All participants that received a single 3 mg dose of omarigliptin.||Participants|||Number
694006|NCT01407276|Primary|Apparent Terminal Half-life (t1/2) of Omarigliptin|T1/2 is the time required for the maximum concentration of a drug in the plasma to decrease by 50%.|Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 (Panel G only), 96, 168, 240, and 336 hours post-dose|All participants that received a single 3 mg dose of omarigliptin.||hour||Standard Deviation|Mean
694007|NCT01407276|Primary|Time to Maximum Concentration (Tmax) of Omarigliptin|Tmax is a measure of the time to reach the maximum drug plasma concentration post-dose.|Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 (Panel G only), 96, 168, 240, and 336 hours post-dose|All participants that received a single 3 mg dose of omarigliptin.||hour||Full Range|Median
694008|NCT01407276|Primary|Cumulative Amount of Drug Excreted in Urine Over 48 Hours (Ae0-48h) of Omarigliptin|Ae0-48h is a measure of the cumulative amount of drug excreted in the urine for 48 hours post-dose. Ae0-48h was only determined for Panels A-F.|Up to 48 hours post-dose|All participants that received a single 3 mg dose of omarigliptin.||mg||95% Confidence Interval|Least Squares Mean
694009|NCT01407276|Primary|Fraction of Dose Excreted Unchanged in Urine Through 48 Hours Post-dose (fe48h) of Omarigliptin|fe48h is expressed as percentage of omarigliptin not metabolized and excreted in urine. fe48h was only determined for Panels A-F.|Up to 48 hours post-dose|All participants that received a single 3 mg dose of omarigliptin.||Percentage of total dose||95% Confidence Interval|Geometric Mean
694010|NCT01407276|Primary|Renal Clearance (CLr) of Omarigliptin|CLr is a calculation of the rate at which a drug is removed from the body via renal clearance pathways, expressed as volume (milliliters) per unit of time (minutes). CLr was only determined for Panels A-F.|Up to 336 hours post-dose|All participants that received a single 3 mg dose of omarigliptin.||mL/min||95% Confidence Interval|Geometric Mean
694011|NCT01407276|Primary|Apparent Total Body Clearance (CL/F) of Omarigliptin|CL/F is a calculation of the rate at which a drug is removed from the body via renal, hepatic, and other clearance pathways, expressed as volume (milliliters) per unit of time (minutes).|Up to 336 hours post-dose|All participants that received a single 3 mg dose of omarigliptin.||mL/min||95% Confidence Interval|Geometric Mean
694012|NCT01407276|Primary|Apparent Volume of Distribution (Vd/F) of Omarigliptin|Vd/F is defined as the distribution of a medication between the plasma and the rest of the body after the dose. It is the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of the drug.|Up to 336 hours post-dose|All participants that received a single 3 mg dose of omarigliptin.||L||95% Confidence Interval|Geometric Mean
694013|NCT01407276|Primary|Concentration at 168 Hours Post-dose (C168h) of Omarigliptin|C168h is a measure of the plasma drug concentration 168 hours post-dose.|168 hours post-dose|All participants that received a single 3 mg dose of omarigliptin.||nM||95% Confidence Interval|Geometric Mean
694014|NCT01407276|Primary|Area Under the Concentration-time Curve From Time 0 to 168 Hours Post Dose (AUC0-168h) of Omarigliptin|AUC0-168h is a measure of the total amount of drug in the plasma from the dose to 168 hours after the dose.|Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 (Panel G only), 96, and 168 hours post-dose|All participants that received a single 3 mg dose of omarigliptin.||nM*hr||95% Confidence Interval|Geometric Mean
694017|NCT01407068|Secondary|Clinical Success by Joint Type|Clinical success is defined as a reduction in fixed flexion contracture to 5° or less 30 days after injection of AA4500.|30 days after injection|Efficacy analysis is based of the intent-to-treat population (ITT). The population is defined as all enrolled subjects who received two injections of AA4500 and had at least one-post-injection measurement.||number of joints|Number of joints||Number
694018|NCT01407068|Primary|Change in Total Range of Motion|The total range of motion is the sum of the range of motion measurements of the two treated joints. Range of motion is defined as difference between full flexion angle and full extension angle expressed in degrees.|30 days after last injection|Efficacy analysis is based of the intent-to-treat population (ITT). The population is defined as all enrolled subjects who received two injections of AA4500 and had at least one-post-injection measurement.||degrees||Standard Deviation|Mean
694019|NCT01407068|Secondary|Investigator Assessment of Improvement With Treatment|"At the Day 60 follow-up visit, the investigator will determine the degree of improvement in the severity of the subject’s treated finger(s) compared with screening as follows:
Very Much Improved
Much improved
Minimally Improved
No Change
Minimally Worse
Much Worse
Very Much Worse"|60 days after last injection|Efficacy analysis is based of the intent-to-treat population (ITT). The population is defined as all enrolled subjects who received two injections of AA4500 and had at least one-post-injection measurement.||participants|||Number
694020|NCT01407068|Secondary|Subject Satisfaction With Treatment|"At the Day 60 follow-up visit, each subject will be asked to rate his/her satisfaction with treatment as follows:
Very Satisfied
Quite Satisfied
Neither Satisfied nor Dissatisfied
Quite Dissatisfied
Very Dissatisfied"|60 days after last injection|Efficacy analysis is based of the intent-to-treat population (ITT). The population is defined as all enrolled subjects who received two injections of AA4500 and had at least one-post-injection measurement.||participants|||Number
694021|NCT01407068|Primary|Percent Change From Baseline in Total Fixed Flexion|Total fixed flexion is defined as the sum of the fixed flexion contractures of the two joints receiving treatment. Change in fixed-flexion contracture is measured in degrees where a decrease of 100% would correspond to a reduction in contracture to 0 degrees|30 days after last injection|Efficacy analysis is based of the intent-to-treat population (ITT). The population is defined as all enrolled subjects who received two injections of AA4500 and had at least one-post-injection measurement.||percentage of contracture change||Standard Deviation|Mean
694022|NCT01406990|Primary|Women With Known CAD Who Are Hyporesponsive to Low Dose (81 mg) Aspirin|Hyporesponsive was defined as Aspirin Response Unit (ARU) > 550 equating to less than 50% platelet inhibition.|Time of enrollment|||participants|||Number
694023|NCT01406938|Secondary|Number of Participants Developing Anti-secukinumab Antibodies|The development of anti-secunimubab anti-bodies will decrease a participant’s ability to respond to secukinumab treatment. The number of participants developing anti-secukinumab anti-bodies was measured from Baseline to week 12, 24, 52 and 8 weeks after treatment at week 60|Baseline, weeks 12, 24, 52 and 60|Full analysis set (FAS) - All patients to whom study treatment was assigned||Number of participants|||Number
694024|NCT01406938|Secondary|Number of Secukinumab Injections Needed to Regain PASI 75 Response From Start of Relapse After Week 12|The number of secukinumab injections needed for participants to regain PASI 75 response from the start of relapse after week 12|week 16, 20, 24,28,32,36,40,44,48,and Week 52|Full analysis set (FAS) - All patients to whom study treatment was assigned||percent of participants|||Number
694025|NCT01406938|Secondary|Number of Visits With PASI 50, 75, 90, 100 Score and IGA Mod 2011 0 or 1|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.|Week 16, 20, 24,28,32,36,40,44,48,and Week 52|Full analysis set (FAS) - All patients to whom study treatment was assigned||Percent of participants|||Number
694026|NCT01406938|Secondary|Percent of Responders With PASI Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100 and Percent of Responders With IGA Score of 0 or 1 Who Failed to Respond to a Previous Biologic Psoriasis Therapy|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.|Week 52|Full analysis set (FAS) - All patients to whom study treatment was assigned, only participants with evaluable data were included||Percent of participants|||Number
694035|NCT01406938|Secondary|Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Maintenance Period))|The IGA mod 2011 is a static scale, i.e., it refers exclusively to the participant’s disease state at the time of the assessments and does not attempt a comparison to any of the participant’s previous disease states at prior visits. The score ranges from 0 (clear) to 4 (severe. The score 0 is clear, 1 is almost clear, 2 is mild, 3 is moderate, and 4 is severe|Baseline, week 16,20,24,28,32,36,40,44,48, and Week 52|Full analysis set (FAS) - All patients to whom study treatment was assigned||Percent of participants|||Number
694364|NCT01401582|Secondary|Person With Dementia: Change in Cognitive Status - Omitted in 2014 Due to Burden on the Proband|The CERAD-test battery (Monsch, 1998) will be used to measure cognitive functioning in several domains|participants will be followed yearly until institutionalisation or death after an expected average of 5 years||05/2017||||
694027|NCT01406938|Secondary|Percent of Responders With PASI Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100 and Percent of Responders With IGA Score of 0 or 1 Who Failed to Respond to a Previous Biologic Psoriasis Therapy|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.|Week 12|Full analysis set (FAS) - All patients to whom study treatment was assigned, only participants with evaluable data were included||Percent of participants|||Number
694028|NCT01406938|Secondary|Median Time to Relapse (Weeks) From Week 12.|Median time to relapse (weeks) from week 12. Relapse is defined as greater than 50% loss of the maximal PASI improvement from baseline. PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). A negative mean percentage change indicates improvement|Week 12 to week 16, 20, 24, 28, 32, 36, 40, 44, 48, and Week 52.|Full analysis set (FAS) - All patients to whom study treatment was assigned||Number of weeks||95% Confidence Interval|Median
694029|NCT01406938|Secondary|% of Participants Achieving a DLQI Score of 0 or 1 at Each Visit up to Week 52, (Maintenance).|"The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). Not relevant is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions"|Baseline to week 16, 20, 24, 28, 32, 36, 40, 44, 48, and Week 52|Full analysis set (FAS) - All patients to whom study treatment was assigned||Percent of participant|||Number
694030|NCT01406938|Secondary|% of Participants Achieving a DLQI Score of 0 or 1 at Each Visit up to Week 52, (Induction)|"The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). Not relevant is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions"|Baseline to week 2, 4, 6, 8, 12|Full analysis set (FAS) - All patients to whom study treatment was assigned||Percent of participants|||Number
694031|NCT01406938|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Score. up to Week 52, (Maintenance)|"The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). Not relevant is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions"|Baseline to week 16, 20, 24, 28, 32, 36, 40, 44, 48, and Week 52.|Full analysis set (FAS) - All patients to whom study treatment was assigned||Units on a scale||Standard Deviation|Mean
694032|NCT01406938|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Score. up to Week 52, (Induction)|"The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). Not relevant is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions"|Baseline to week 2, 4, 8, 12|Full analysis set (FAS) - All patients to whom study treatment was assigned||Units on a scale||Standard Deviation|Mean
694033|NCT01406938|Secondary|Change From Baseline in EQ-5D at Each Visit, up to Week 52, (Maintenance)|ED-5Q: Participant rated questionnaire to assess health related quality of life in terms of a single utility score. Five domains are assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with three possible score: 1 indicates no problems, better state of health; 3 indicates worst state of health (example “confined to bed”) A visual analog scale (VAS) assesses the health status from 0 (worst possible health state) to 100 (best possible health state)|Baseline to week 16, 20, 24, 28, 32, 36, 40, 44, 48, and Week 52.|Full analysis set (FAS) - All patients to whom study treatment was assigned||Units on a scale||Standard Deviation|Mean
694034|NCT01406938|Secondary|Change From Baseline in EQ-5D at Each Visit, up to Week 52, (Induction)|ED-5Q: Participant rated questionnaire to assess health related quality of life in terms of a single utility score. Five domains are assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with three possible score: 1 indicates no problems, better state of health; 3 indicates worst state of health (example “confined to bed”) A visual analog scale (VAS) assesses the health status from 0 (worst possible health state) to 100 (best possible health state)|Baseline to week 2, 4, 8, 12|Full analysis set (FAS) - All patients to whom study treatment was assigned||Units on a scale||Standard Deviation|Mean
694051|NCT01406574|Secondary|Best Overall Response|Overall response was evaluated based on the Response Evaluation Criteria in Solid Tumors (RECIST guideline) - mRECIST 1.0.|From first dose of study medication up to 28 weeks|"Efficacy population included all treated subjects who had received at least 1 dose of study drug.
No statistical analysis provided for Best Overall Responders."||participants|||Number
694036|NCT01406938|Secondary|Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Induction)|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe|Baseline, week 2, 4, 6, 8, 12|Full analysis set (FAS) - All patients to whom study treatment was assigned||Percent of participant|||Number
694037|NCT01406938|Secondary|Absolute Change From Baseline for PASI 50 / 75 / 90 / 100 and IGA 2011 Score of 0 or 1 at Week at Week 16, 20, 24,28,32,36,40,44,48,and Week 52|PASI: Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section(head:01, arms:0.2 body:0.3 legs:0.4)|Baseline, week 12,16,20,24,28,32,36,40,44,48 and week 52|Full analysis set (FAS) - All patients to whom study treatment was assigned||Units on a scale||Standard Deviation|Mean
694038|NCT01406938|Secondary|Absolute Change From Baseline for PASI 50 / 75 / 90 / 100 and IGA 2011 Score of 0 or 1 at Week 2, 4, 6, 8, 12|PASI: Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section(head:01, arms:0.2 body:0.3 legs:0.4)|Baseline, week 2, 3 , 4, 8, 12|Full analysis set (FAS) - All patients to whom study treatment was assigned||Units on a scale||Standard Deviation|Mean
694039|NCT01406938|Primary|For the Fixed Interval Group and the Start of Relapse (SoR) Group, the Percentage of Participants (Who Responded to Treatment at Week 12) Maintaining a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 52|PASI: Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section(head: 0.1, arms: 0.2 body: 0.3 legs: 0.4)|Week 40 , week 52|Full analysis set (FAS) - All patients to whom study treatment was assigned.||Percent of participants|||Number
694040|NCT01406795|Secondary|Villalta PTS Scale|The Villalta PTS Scale is a score based on the patient's symptoms, includes cramps, pain, and redness. It is scaled from 0 to 48, with a higher score representing more severe disease.|up to 2 years|Data were not collected for this outcome.|||||
694041|NCT01406795|Secondary|VEINS-QOL|The VEINS-QOL is a questionnaire that represents a patient's quality of life, using measures like how well the patient can walk, sleep, and enjoy life. Responses are graded on a scale of 1-5, with 1 being very good, and 5 being very poor. The VEINS-QOL measure is defined by the count of participants that showed a decreased overall score following their procedure.|Up to 2 years|||Participants|||Count of Participants
694042|NCT01406795|Secondary|Venous Clinical Severity Score|Venous Clinical Severity represents the severity of the venous pathology, which includes measures like pain, inflammation, and number of ulcers. It is scored on a scale of 0-3 with the upper end representing very severe outcomes for the patient.|up to 2 years|Data were not collected for this outcome|||||
694043|NCT01406795|Secondary|Decrease in Swelling of Affected Extremity|The count of participants that experienced a decrease in swelling after the stent was placed.|up to 2 years|||Participants|||Count of Participants
694044|NCT01406795|Secondary|Adverse Events|Adverse events were reported as the count of participants that experienced an adverse event within two years of their procedure.|up to two years 2 years|||Participants|||Count of Participants
694045|NCT01406795|Secondary|Secondary Patency|Secondary patency means that the initial intervention failed and a second intervention was performed to establish or maintain patency. Secondary patency is defined as the count of participants that required a second intervention to establish patency.|up to 1 year|||Participants|||Count of Participants
694046|NCT01406795|Secondary|Assisted-primary Patency|Patency refers to whether the stent is unoccluded (open). Primary refers to the first time a stent was placed (or the first time patency needed to be established). Assisted refers to the fact that a device (like a balloon) was used to open the stent. Assisted-primary patency is defined as the count of participants that demonstrated the need for an intervention to establish patency.|up to 1 year|||Participants|||Count of Participants
694047|NCT01406795|Secondary|Freedom From Device-related Amputation|Freedom from device-related amputation (amputation of infected limb) is reported as the count of participants with no device-related amputation within 1 year following stent placement.|up to 1 year following the procedure|||Participants|||Count of Participants
694048|NCT01406795|Primary|Primary Patency Rate|Patency refers to whether the stent is unoccluded (open). Primary patency rate was defined as the count of participants with >= 50% patency following initial stent placement, and is reported as the count of participants meeting this criteria.|up to 1 year following the procedure|||Participants|||Count of Participants
694049|NCT01406795|Primary|Stent Migration|Stent migration is reported as the count of participants with stent migration within 1 year following stent placement.|up to one year following the procedure 1 year|||Participants|||Count of Participants
694050|NCT01406795|Primary|Stent Migration|Stent migration is reported as the count of participants with stent migration within 1 month following stent placement.|up to 1 month following the procedure|||Participants|||Count of Participants
694052|NCT01406574|Primary|Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)|"Recommended Dose (RD) of OPB-31121 was defined as the highest dose at which Dose Limited Toxicity (DLT) occurred at an incidence of < 30%.
DLT was defined as adverse events related to OPB-31121 occurring until Day 32, and 1) Grade 4 neutrophil count decreased persisting for ≧ 8 days, or Grade 3 or 4 febrile neutropenia, or infection with neutrophil count decreased 2) Grade 4 Plt decreased, or Grade 3 Plt decreased persisting for ≧ 8 days 3) Grade 3 or 4 nausea, vomiting, or diarrhoea that occurred despite the use of an anti-emetic or anti-diarrheal agents 4) Grade 3 or more severe AEsa excluding the AEs presented above 1) to 3) 5) AEs requiring interruption of IMP administration for a period of ≧ 8 consecutive days 6) Same AEs causing interruption of IMP administration twice"|From first study medication to on Day 32 (after repeated 28 days medication from Day 4 to 32)|"DLT evaluated subjects who had achieved ≧75% study drug compliance during a 4-week (28-day) treatment period starting from Day 4.
No statistical analysis provided for Subjects With DLTs."||participants|||Number
694053|NCT01406574|Primary|Subjects With Treatment Emergent Adverse Events|Treatment emergent adverse events observed during outcome measure time frame.|From first study medication to on Day 32 (after repeated 28 days medication from Day 4 to 32)|Safety population No statistical analysis provided for Subjects With Treatment Emergent Adverse Events.||participants|||Number
694056|NCT01406015|Secondary|Change From Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)|Insulin resistance was measured using the 75 G glucose tolerance test. Participants ingested 75 grams of glucose in 300-400 mL of water over 5 minutes. Blood samples were taken before ingesting glucose and then every 30 minutes for 120 minutes. HOMA-IR was calculated using the Insulin and glucose levels obtained. A negative change (decrease in insulin resistance) indicates improvement.|Baseline and Week 6 (Prior to ingesting glucose and every 30 minutes for 120 minutes)|All randomized participants who completed the study.||IR index||Standard Deviation|Mean
694057|NCT01406015|Secondary|Change From Baseline in Insulin Sensitivity Index (ISI)|Insulin sensitivity was measured using the 75 gram (G) glucose tolerance test. Participants ingested 75 grams of glucose in 300-400 milliliters (mL) of water over 5 minutes. Blood samples were taken before ingesting glucose and then every 30 minutes for 120 minutes. Insulin sensitivity index was calculated by Matsuda and Defronzo’s formula using the values obtained. A positive change from Baseline (increase in insulin sensitivity) indicates improvement.|Baseline and Week 6 (Prior to ingesting glucose and every 30 minutes for 120 minutes)|All randomized participants who completed the study.||IS index||Standard Deviation|Mean
694058|NCT01406015|Secondary|Change From Baseline in Markers of Inflammation|Blood was to be collected and tested for Tumor Necrosis Factor Alpha (TNF-α) and Monocyte Chemotactic Protein-1 (MCP-1), markers of inflammation; However, due to lack of funding, blood samples were not analyzed and data for levels of inflammation markers were not collected.|Baseline and Week 6|Analysis was not performed.|||||
694059|NCT01406015|Secondary|Change From Baseline in Para-aminohippurate (PAH) Clearance|Renal plasma blood flow was determined by clearance of para-aminohippurate (PAH). A loading dose of PAH (8 mg/kg) was given intravenously followed by a 1 hour constant infusion of PAH at a rate of 12 mg/minute (min). Plasma samples were obtained at Baseline and at 50 and 60 minutes. PAH clearance was calculated from the plasma levels and infusion rates and reported in millimeters (mL)/minute (min). A positive change from Baseline indicates improvement.|Baseline and Week 6 (Prior to PAH infusion and at 50 and 60 minutes post PAH infusion)|All randomized participants who completed the study.||mL/min||Standard Deviation|Mean
694060|NCT01406015|Primary|Change From Baseline in Post-ischemic Dilatation|Ultrasonography of the brachial artery was performed to evaluate endothelial function by flow mediated dilatation (FMD) studies. A blood pressure cuff was placed on the participant's upper arm and was compressed for 5 minutes. After release of compression, brachial artery diameter and blood flow velocity were measured. FMD was expressed as the percentage change in brachial artery diameter. A positive change from Baseline indicates improvement.|Baseline and Week 6|All randomized participants who completed the study.||percent dilalation||Standard Deviation|Mean
694061|NCT01405950|Secondary|Pharmacokinetic (PK) Parameter Cmax (Maximum Observed Drug Concentration in Plasma) of a Single Dose of Tizanidine at 4 Different Dose Levels in Children and Adolescents With Cerebral Palsy and Mild to Moderate Spasticity.|"Baseline: immediately before the standardized meal (i.e., before administration of tizanidine) on dosing day
0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours after administration of tizanidine
PK parameters will be derived by using WinNonlin Pro (version 5.0.1 or later, Pharsight Corp)."|Baseline and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours|Pharmacokinetics Population||nanogram/mililiter||Standard Error|Mean
694062|NCT01405950|Primary|Pharmacokinetic (PK) Parameter AUC0–8 (Area Under the Concentration-time Curve From Time 0 to 8 Hours) of a Single Dose of Tizanidine at 4 Different Dose Levels in Children and Adolescents With Cerebral Palsy and Mild to Moderate Spasticity.|"Baseline: immediately before the standardized meal (i.e., before administration of tizanidine) on dosing day
0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours after administration of tizanidine
PK parameters will be derived by using WinNonlin Pro (version 5.0.1 or later, Pharsight Corp)."|Baseline and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours|Pharmacokinetics Population||hour*nanogram/mililiter||Standard Error|Mean
694091|NCT01405794|Primary|Cytochrome P450 Assay on Caffeine in Participants|Assessment Placebo (14 Days) and 32ppm Oral Silver (14 Days). Cytochrome P450 assay is used to determine the function of how Dextromethorphan metabolized. The value represents the peak absorption of the 450 enzyme when dextromethorphan is given during the Silver or Placebo Arm.|14 Days|||ng/ml||Standard Deviation|Mean
694063|NCT01405937|Primary|Percentage of Participants Who Discontinued Study Drug Due to an AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the product, was also an AE.|From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 48 weeks)|All Participants Treated (APaT) Population; all participants receiving at least one dose of study treatment||percentage of participants|||Number
694064|NCT01405937|Secondary|Mean Change From Baseline in HCV RNA (Log 10)|"HCV RNA levels were assessed at baseline (BL) and during treatment weeks 2, 4, 8, 12, and 24 using the Roche TaqMan HCV assay, and transformed to Log 10 values. HCV RNA values below the limit of reliable quantification (LoQ) or the limit of detection (LoD) at any time point were handled as follows (imputations done for computational purposes): values below the LoQ but above the LoD were imputed with the LoQ minus 0.1; values below the LoD were imputed with the value of 0 Log IU/mL. HCV RNA levels below the LoD were considered undetectable."|Baseline, Week 2, Week 4, Week 8, Week 12, Week 24|Participants in the FAS population (all randomized participants who received at least one dose of study treatment) that had HCV RNA data available.||Log IU/ml||Standard Deviation|Mean
694065|NCT01405937|Primary|Percentage of Participants With One or More Specific Adverse Events (AEs) of Special Interest During the Study|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the product, was also an AE. For this study, safety parameters or AEs of special interest that were identified a priori included serious rash, anemia (anemia plus haemoglobin decreased), neutropenia (neutropenia plus neutrophil count decreased), bilirubin increased and gastrointestinal (GI) adverse experiences (vomiting, nausea, and diarrhea). The percentage of participants with ≥1 specific AEs were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen.|From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 48 weeks)|All Participants Treated (APaT) Population; all participants receiving at least one dose of study treatment||percentage of participants||95% Confidence Interval|Number
694066|NCT01405937|Secondary|Percentage of Participants Achieving Undetectable HCV RNA at the End of Treatment (EOT)|Participants were assessed for undetectable HCV RNA levels at the end of all study therapy. The percentage of participants with undetectable HCV RNA levels at EOT were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen.|At Week 24|FAS population; all randomized participants who received at least one dose of study treatment.||Percentage of participants||95% Confidence Interval|Number
694067|NCT01405937|Secondary|Percentage of Participants Achieving Complete Early Virologic Response (cEVR)|cEVR was defined as having an undetectable HCV RNA level at Week 12. The percentage of participants achieving cEVR were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen.|At Week 12|FAS population; all randomized participants who received at least one dose of study treatment.||Percentage of participants||95% Confidence Interval|Number
694068|NCT01405937|Secondary|Percentage of Participants Achieving Rapid Virologic Response (RVR)|RVR was defined as having an undetectable HCV RNA level at Week 4. The percentage of participants achieving RVR were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen.|At Week 4|FAS population; all randomized participants who received at least one dose of study treatment.||percentage of participants||95% Confidence Interval|Number
694069|NCT01405937|Secondary|Percentage of Participants Achieving SVR12|SVR12 was defined as having an undetectable HCV RNA level 12 weeks after completion of all study therapy. The percentage of participants achieving SVR12 were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen.|12 weeks after 24 weeks of study therapy (up to 36 weeks)|FAS population; all randomized participants who received at least one dose of study treatment.||percentage of participants||95% Confidence Interval|Number
694070|NCT01405937|Primary|Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Completion of All Study Therapy (SVR24)|SVR24 was defined as having an undetectable HCV RNA level 24 weeks after completion of all study therapy. The percentage of participants achieving SVR24 were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen.|24 weeks after 24 weeks of study therapy (up to 48 weeks)|Full Analysis Set (FAS) population; all randomized participants who received at least one dose of study treatment.||percentage of participants||95% Confidence Interval|Number
694071|NCT01405924|Secondary|Percentage of Participants Who Used No Rescue Medication During Cycle 2 of Chemotherapy|Participants recorded any use of rescue medication for established nausea/vomiting in their daily diaries from initiation of chemotherapy infusion through the morning of Day 6. The percentage of participants who used no rescue medication during Cycle 2 of chemotherapy was calculated.|Up to 120 hours following initiation of chemotherapy in Cycle 2|The population consisted of all participants who received chemotherapy, received a dose of study drug, had no protocol deviations and had complete data.||Percentage of Participants|||Number
694072|NCT01405924|Secondary|Percentage of Participants With No Significant Nausea During Cycle 2 of Chemotherapy|"Participants rated their degree of nausea in response to How much nausea have you had over the last 24 hours? using a 100-mm visual analog scale (VAS, 0=no nausea, 100=nausea as bad as it could be) on Days 2-6 following initiation of chemotherapy. No significant nausea was defined as VAS score <25 mm over the 24-120 hours following initiation of chemotherapy. The percentage of participants who experienced no significant nausea during Cycle 2 of chemotherapy was calculated."|From 24 to 120 hours following initiation of chemotherapy in Cycle 2|The population consisted of all participants who received chemotherapy, received a dose of study drug, had no protocol deviations and had complete data.||Percentage of Participants|||Number
694092|NCT01405794|Primary|Cytochrome P450 Assay on Losartan in Participants|Assessment Placebo (14 Days) and 32ppm Oral Silver (14 Days). Cytochrome P450 assay is used to determine the function of how Dextromethorphan metabolized. The value represents the peak absorption of the 450 enzyme when dextromethorphan is given during the Silver or Placebo Arm.|14 Days|||ng/ml||Standard Deviation|Mean
707213|NCT00121225|Secondary|Effect of Vorinostat on HP1 and macroH2A Nuclear Foci|Compared with Fisher’s exact test to determine utility as biomarkers of response.|Baseline and day 15||||||
694073|NCT01405924|Secondary|Functional Living Index - Emesis (FLIE) Total Score During Cycle 2 of Chemotherapy|"The FLIE Total Score is an 18-question quality-of-life questionnaire on the impact of nausea and vomiting (9 questions on nausea and 9 questions on vomiting) on daily life. Each question uses a visual analog scale (VAS) to rate the impact of nausea/vomiting from 1 to 7. FLIE Total Scores are calculated by summing the responses to the 18 questions and can range from 18-126 (18=a great deal of impairment, 126=no impairment), with a higher score indicating less impairment due to nausea and vomiting. No Impact on daily life was defined as a FLIE Total Score >108. Participants completed the FLIE questionnaire on the morning of Day 6 following initiation of chemotherapy in Cycle 2; their responses covered their experiences with nausea and vomiting over the previous 5 days."|From Day 1 (prior to initiation of chemotherapy in Cycle 2) to morning of Day 6 (up to ~120 hours following initiation of chemotherapy in Cycle 2)|The population consisted of all participants who received chemotherapy, received a dose of study drug, had no protocol deviations and had complete data.||Score on a Scale||Standard Deviation|Mean
694074|NCT01405924|Secondary|Percentage of Participants With a Complete Response During Cycle 2 of Chemotherapy|A complete response is defined as no vomiting/no retching episodes and no use of rescue medication during the 120 hours following initiation of chemotherapy. The percentage of participants with a complete response during Cycle 2 of chemotherapy was calculated.|Up to 120 hours following initiation of chemotherapy in Cycle 2|The population consisted of all participants who received chemotherapy, received a dose of study drug, had no protocol deviations and had complete data.||Percentage of Participants|||Number
694075|NCT01405924|Secondary|Percentage of Participants With No Vomiting and No Retching During Cycle 2 of Chemotherapy Per Type of Chemotherapy|A vomiting episode is defined as one or more episodes of emesis (expulsion of stomach contents through the mouth) or retching (an attempt to vomit that is not productive of stomach contents). Distinct vomiting episodes are separated by the absence of emesis and retching for at least one minute. The date and time of each vomiting episode was recorded by participants in diaries at the time of occurrence. The percentage of partcipants with no vomiting and no retching episodes 0-120 hours following initiation of chemotherapy in Cycle 2 was calculated based on type of chemotherapy received.|Up to 120 hours following initiation of chemotherapy in Cycle 2|The population consisted of all participants who received chemotherapy, received a dose of study drug, had no protocol deviations and had complete data. Participants were grouped into 2 cohorts based on type of chemotherapy received.||Percentage of Participants|||Number
694076|NCT01405924|Primary|Percentage of Participants With No Vomiting and No Retching During Cycle 2 of Chemotherapy|A vomiting episode is defined as one or more episodes of emesis (expulsion of stomach contents through the mouth) or retching (an attempt to vomit that is not productive of stomach contents). Distinct vomiting episodes are separated by the absence of emesis and retching for at least one minute. The date and time of each vomiting episode was recorded by participants in diaries at the time of occurrence. The percentage of partcipants with no vomiting and no retching episodes 0-120 hours following chemotherapy in Cycle 2 was calculated.|Up to 120 hours following initiation of chemotherapy in Cycle 2|The population consisted of all participants who received chemotherapy, received a dose of study drug, had no protocol deviations and had complete data.||Percentage of Participants|||Number
694077|NCT01405898|Secondary|Difference in Change in Arterial Stiffness From Baseline|carotid-femoral pulse wave velocity [m/s] measured by Vicorder|4 weeks|||m/s||Standard Deviation|Mean
694078|NCT01405898|Primary|Difference in Change in Ambulatory Diastolic Blood Pressure From Baseline||4 weeks|||mmHg||Standard Deviation|Mean
694079|NCT01405898|Primary|Difference in Change in Ambulatory Systolic Blood Pressure From Baseline||4 weeks|||mmHg||Standard Deviation|Mean
694080|NCT01405898|Primary|Difference in Change in Clinic Diastolic Blood Pressure From Baseline||4 weeks|||mmHg||Standard Deviation|Mean
694081|NCT01405898|Secondary|Difference in Change in Endothelial Function From Baseline|as measured by flow-mediated dilatation [%change in diameter of vessel] - an increase in diameter demonstrates an improvement in endothelial function|4 weeks|||% dilatation||Standard Deviation|Mean
694082|NCT01405898|Secondary|Difference in Change in Plasma Nitrite Concentration From Baseline||4 weeks|||umol/L||Standard Deviation|Mean
694083|NCT01405898|Primary|Difference in Change in Clinic Systolic Blood Pressure From Baseline||4 weeks|||mmHg||Standard Deviation|Mean
694084|NCT01405820|Primary|Cumulative Number of Combined Unique Active Lesions|Cumulative number of combined unique active lesions (sum of the number of new gadolinium (Gd)-enhancing lesions and new or newly enlarging T2 hyperintense lesions not associated with Gd-enhancement on T1 weighted scans) based on brain magnetic resonance imaging (MRI) scans Up to Week 60.|Up to Week 60|Modified intent-to-treat (mITT) population: all randomized participants who received at least 1 dose of study drug, had at least 1 efficacy assessment, and had no statistical protocol deviations.||lesions||Standard Deviation|Mean
694085|NCT01405794|Secondary|Total Change in Heart Rate in Silver Participants|Assessment only completed on the 32ppm Oral Silver part of the trail|Baseline and 14 Days|||beats per minute||95% Confidence Interval|Mean
694086|NCT01405794|Secondary|Total Change in Diastolic Blood Pressure Silver Participants|Assessment only completed on the 32ppm Oral Silver part of the trail|Baseline and 14 Days|||mmhg||95% Confidence Interval|Mean
694087|NCT01405794|Secondary|Total Change in Systolic Blood Pressure Silver Participants|Assessment only completed on the 32ppm Oral Silver part of the trail|Baseline and 14 Days|||mmhg||95% Confidence Interval|Mean
694088|NCT01405794|Primary|Cytochrome P450 Assay on Midazolam in Participants|Assessment Placebo (14 Days) and 32ppm Oral Silver (14 Days). Cytochrome P450 assay is used to determine the function of how Dextromethorphan metabolized. The value represents the peak absorption of the 450 enzyme when dextromethorphan is given during the Silver or Placebo Arm.|14 Days|||ng/ml||Standard Deviation|Mean
694089|NCT01405794|Secondary|Cytochrome P450 Assay on Chlorozoxazone in Participants Dosed With Silver|Assessment Placebo (14 Days) and 32ppm Oral Silver (14 Days). Cytochrome P450 assay is used to determine the function of how Dextromethorphan metabolized. The value represents the peak absorption of the 450 enzyme when dextromethorphan is given during the Silver or Placebo Arm.|14 Days|||ng/ml||Standard Deviation|Mean
694090|NCT01405794|Primary|Cytochrome P450 Assay on Omeprazole in Participants|Assessment Placebo (14 Days) and 32ppm Oral Silver (14 Days). Cytochrome P450 assay is used to determine the function of how Dextromethorphan metabolized. The value represents the peak absorption of the 450 enzyme when dextromethorphan is given during the Silver or Placebo Arm.|14 Days|||ng/ml||Standard Deviation|Mean
694093|NCT01405794|Primary|Cytochrome P450 Assay on Dextromethorphan in Participants|Assessment Placebo (14 Days) and 32ppm Oral Silver (14 Days). Cytochrome P450 assay is used to determine the function of how Dextromethorphan metabolized. The value represents the peak absorption of the 450 enzyme when dextromethorphan is given during the Silver or Placebo Arm.|14 Days|||ng/ml||Standard Deviation|Mean
694094|NCT01405794|Primary|Change In Eosinophils Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days|||percent||Standard Deviation|Mean
694095|NCT01405794|Primary|Change In Basophils Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days|||percent||Standard Deviation|Mean
694096|NCT01405794|Primary|Change In Monocytes Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days|||percent||Standard Deviation|Mean
694097|NCT01405794|Primary|Change In Lymphocytes Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days|||percent||Standard Deviation|Mean
694098|NCT01405794|Primary|Change In Granulocytes Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days|||percent||Standard Deviation|Mean
694099|NCT01405794|Primary|Change In Platelet Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days|||k/uL||Standard Deviation|Mean
694100|NCT01405794|Primary|Change In Mean Corpuscular Hemoglobin Concentration Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days|||gm/dL||Standard Deviation|Mean
694101|NCT01405794|Primary|Change In Mean Corpuscular Volume Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days|||fL||Standard Deviation|Mean
694102|NCT01405794|Primary|Change In Hematocrit Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days|||percent||Standard Deviation|Mean
694103|NCT01405794|Primary|Change In Hemoglobin Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days|||gm/dL||Standard Deviation|Mean
694104|NCT01405794|Primary|Change In Red Blood Count Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days|||M/uL||Standard Deviation|Mean
694105|NCT01405794|Primary|Change In White Blood Count Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days|||k/uL||Standard Deviation|Mean
694106|NCT01405794|Primary|Change In Calcium Blood Level|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days|||mg/dL||Standard Deviation|Mean
694107|NCT01405794|Primary|Change In Albumin Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days|||g/dL||Standard Deviation|Mean
694108|NCT01405794|Primary|Change In Total Bilirubin Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days|||mg/dL||Standard Deviation|Mean
694109|NCT01405794|Primary|Change in Total Protein Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days|||g/dL||Standard Deviation|Mean
694110|NCT01405794|Primary|Change In Alanine Aminotransferase Blood Level|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days|||U/L||Standard Deviation|Mean
694111|NCT01405794|Primary|Change In Aspartate Aminotransferase Blood Level|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days|||U/L||Standard Deviation|Mean
694112|NCT01405794|Primary|Change In Alkaline Phosphatase Blood Level|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days|||U/L||Standard Deviation|Mean
694113|NCT01405794|Primary|Change In Glucose Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days|||mg/dl||Standard Deviation|Mean
694114|NCT01405794|Primary|Change In Creatinine Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days|||mg/dL||Standard Deviation|Mean
694115|NCT01405794|Primary|Change In Urea Nitrogen Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 days|||mg/dL||Standard Deviation|Mean
694116|NCT01405794|Primary|Change in Carbon Dioxide Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 days|||mmol/L||Standard Deviation|Mean
694117|NCT01405794|Primary|Change in Chloride Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 days|||mmol/L||Standard Deviation|Mean
694118|NCT01405794|Primary|Change Potassium Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 days|||mmol/L||Standard Deviation|Mean
694119|NCT01405794|Primary|Change Sodium Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days|||mmol/L||Standard Deviation|Mean
694120|NCT01405768|Secondary|Overall LEEP Procedure Pain Including Procedural Pain and Cramping (Median)|"A Likert visual analog scale will be used to determine the overall pain experienced by each study participant including injection pain, procedural pain, and cramping.
Within 30 minutes of completion of the procedure and after instruction by the investigators, women reported the intensity of their pain by marking single lines across 100-mm Likert visual analog scales. Scales did not include hashmarks or internal descriptors, as these have been shown to bias responses and diminish reliability.
Patient marks on 100-mm Likert scale lines were measured, and a score was determined by the length marked off in millimeters. Patients who wrote no pain were considered to have marked 0 mm."|Within 30 minutes of completion of procedure|||units on a scale||Full Range|Median
694121|NCT01405768|Primary|Injection Pain Score (Median)|"A Likert visual analog scale will be used to document each study participant's level of pain experienced during injection of the cervical block.
Within 30 minutes of completion of the procedure and after instruction by the investigators, women reported the intensity of their pain by marking single lines across 100-mm Likert visual analog scales. Scales did not include hashmarks or internal descriptors, as these have been shown to bias responses and diminish reliability.
Patient marks on 100-mm Likert scale lines were measured, and a score was determined by the length marked off in millimeters. Patients who wrote no pain were considered to have marked 0 mm."|Within 30 minutes of completion of the procedure|||units on a scale||Full Range|Median
694134|NCT01405560|Primary|Percentage of Participants Achieving Sustained Virologic Response (SVR)24|SVR24 was defined as having an undetectable HCV RNA level 24 weeks after completion of all study therapy. The percentage of participants achieving SVR24 were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen.|24 weeks after 24 weeks of study therapy (up to 48 weeks)|Full Analysis Set (FAS) population; all randomized participants who received at least one dose of study treatment.||percentage of participants||95% Confidence Interval|Number
694122|NCT01405768|Secondary|Overall LEEP Procedure Pain Including Procedural Pain and Cramping (Mean)|"A Likert visual analog scale will be used to determine the overall pain experienced by each study participant including injection pain, procedural pain, and cramping.
Within 30 minutes of completion of the procedure and after instruction by the investigators, women reported the intensity of their pain by marking single lines across 100-mm Likert visual analog scales. Scales did not include hashmarks or internal descriptors, as these have been shown to bias responses and diminish reliability.
Patient marks on 100-mm Likert scale lines were measured, and a score was determined by the length marked off in millimeters. Patients who wrote no pain were considered to have marked 0 mm."|Within 30 minutes of completion of procedure|||units on a scale||Standard Deviation|Mean
694123|NCT01405768|Primary|Injection Pain Score (Mean)|"A Likert visual analog scale will be used to document each study participant's level of pain experienced during injection of the cervical block.
Within 30 minutes of completion of the procedure and after instruction by the investigators, women reported the intensity of their pain by marking single lines across 100-mm Likert visual analog scales. Scales did not include hashmarks or internal descriptors, as these have been shown to bias responses and diminish reliability.
Patient marks on 100-mm Likert scale lines were measured, and a score was determined by the length marked off in millimeters. Patients who wrote no pain were considered to have marked 0 mm."|Within 30 minutes of completion of procedure|||units on a scale||Standard Deviation|Mean
694124|NCT01405742|Secondary|F.VIII Activity|F.VIII Activity (IU/mL) performed at week 8 and week 34, i.e. 8 weeks after initiation of factor dosing in Weeks 1-26, and 8 weeks after initiation of factor dosing in Weeks 27-52.|The time frame is 52 weeks per subject.|||IU/mL||Full Range|Median
694125|NCT01405742|Secondary|Inter-dose Hypocoagulability by Thrombin Generation|Thrombin generation was performed at week 8 and week 34, i.e. 8 weeks after initiation of factor dosing in Weeks 1-26, and 8 weeks after initiation of factor dosing in Weeks 27-52.|The time frame is 52 weeks per subject.|||nMs||Full Range|Median
694126|NCT01405742|Primary|Number of Bleeds|The primary outcome was bleed frequency. The data were total number of events for each Arm, and not per-participant.|Weeks 26 (first intervention) and 52 (second intervention)|3 completing study were analyzed||bleeds per 26 weeks|||Number
694127|NCT01405560|Primary|Percentage of Participants Who Discontinued Study Drug Due to an AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the product, was also an AE.|From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 48 weeks)|All Participants Treated (APaT) Population; all participants receiving at least one dose of study treatment||percentage of participants|||Number
694128|NCT01405560|Secondary|Mean Change From Baseline in HCV RNA (Log 10)|"HCV RNA levels were assessed at baseline (BL) and during treatment weeks 2, 4, 8, 12, and 24 using the Roche TaqMan HCV assay, and transformed to Log 10 values. HCV RNA values below the limit of reliable quantification (LoQ) or the limit of detection (LoD) at any time point were handled as follows (imputations done for computational purposes): values below the LoQ but above the LoD were imputed with the LoQ minus 0.1; values below the LoD were imputed with the value of 0 Log IU/mL. HCV RNA levels below the LoD were considered undetectable."|Baseline, Week 2, Week 4, Week 8, Week 12, Week 24|FAS population; all randomized participants who received at least one dose of study treatment.||Log IU/ml||Standard Deviation|Mean
694129|NCT01405560|Secondary|Percentage of Participants Achieving Undetectable HCV Ribonucleic Acid (RNA) at the End of Treatment (EOT)|Participants were assessed for undetectable HCV RNA levels at the end of all study therapy. The percentage of participants with undetectable HCV RNA levels at EOT were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen.|At Week 24|FAS population; all randomized participants who received at least one dose of study treatment.||percentage of participants||95% Confidence Interval|Number
694130|NCT01405560|Secondary|Percentage of Participants Achieving Complete Early Virologic Response (cEVR)|cEVR was defined as having an undetectable HCV RNA level at Week 12. The percentage of participants achieving cEVR were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen.|At Week 12|FAS population; all randomized participants who received at least one dose of study treatment.||percentage of participants||95% Confidence Interval|Number
694131|NCT01405560|Secondary|Percentage of Participants Achieving Rapid Virologic Response (RVR)|RVR was defined as having an undetectable HCV RNA level at Week 4. The percentage of participants achieving RVR were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen.|At Week 4|FAS population; all randomized participants who received at least one dose of study treatment.||percentage of participants||95% Confidence Interval|Number
694132|NCT01405560|Secondary|Percentage of Participants Achieving SVR12|SVR12 was defined as having an undetectable HCV RNA level 12 weeks after completion of all study therapy. The percentage of participants achieving SVR12 were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen.|12 weeks after 24 weeks of study therapy (up to 36 weeks)|FAS population; all randomized participants who received at least one dose of study treatment.||percentage of participants||95% Confidence Interval|Number
694133|NCT01405560|Primary|Percentage of Participants With One or More Specific Adverse Events (AEs) of Special Interest During the Study|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the product, was also an AE. For this study, safety parameters or AEs of special interest that were identified a priori included serious rash, anemia (anemia plus haemoglobin decreased), neutropenia (neutropenia plus neutrophil count decreased), bilirubin increased and gastrointestinal adverse experiences (vomiting, nausea, and diarrhea). The percentage of participants with ≥1 specific AEs were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen.|From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 48 weeks)|All Participants Treated (APaT) Population; all participants receiving at least one dose of study treatment||percentage of participants||95% Confidence Interval|Number
707214|NCT00121225|Secondary|Time to Progression Assessed by RECIST||Up to 5 years||||||
694135|NCT01405508|Secondary|Number of Subjects With at Least One Injection-related Treatment-emergent Adverse Event (TEAE) During the Evaluation Period.|An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|4.5-day Evaluation Period|Safety Population consisting of all subjects who took at least 1 dose of study drug.||Participants|||Number
694136|NCT01405508|Secondary|Number of Subjects Who Withdrew Due to a Treatment-emergent Adverse Event During the Study (Maximum 40 Days)|An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|40 days|Safety Population consisting of all subjects who took at least 1 dose of study drug.||Participants|||Number
694137|NCT01405508|Primary|Number of Subjects With at Least One Treatment-emergent Adverse Event During the Study (Maximum 40 Days)|An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|40 days|Safety Population consisting of all subjects who took at least 1 dose of study drug.||Participants|||Number
694138|NCT01405469|Secondary|Percentage of Participants Who Achieved Treatment Success 3 Months After Treatment|"eckhardt score is a score to evaluate achalasia discomfort in patients. Patients are being interrogated for dysphagia, regurgitation, and retrosternal pain , correlated with the time frame of occurrence. with every meal giving 3 points, daily (2 points), sometimes (1 Point) or no (0 Points), as well as weight loss,(>10 kg= 3 points, 5-10 kg=2 points, 0-5 kg=1 point, None=0 points. Scale range is from 0 Points (no achalasia) up to 12 points for the worst achalasia symptoms. Post-myotomy eckhardt score ≤ 3 n individuals has been reached in 15 individuals."|3 months after treatment|Pilot study group to evaluate feasibility and safety of POEM procedure before initiating studies evaluating long-term efficacy.Patients with primary achalasia, diagnosed by established methods(contrast fluoroscopy, manometry, esophagogastroduodenoscopy(EGD)) and age greater than 18 years were included.||percentage of treated patients|||Number
694139|NCT01405469|Secondary|cm Myotomy Length|myotomy length in cm|POEM procedure|Pilot study group to evaluate feasibility and safety of POEM procedure before initiating studies evaluating long-term efficacy.Patients with primary achalasia, diagnosed by established methods(contrast fluoroscopy, manometry, esophagogastroduodenoscopy(EGD)) and age greater than 18 years were included.||cm||Standard Deviation|Mean
694140|NCT01405469|Secondary|Days Duration Hospitalization|participants were followed for the duration of hospital stay, an average of 4 days|days of hospitalization for POEM procedure, an average of 4 days|Pilot study group to evaluate feasibility and safety of POEM procedure before initiating studies evaluating long-term efficacy.Patients with primary achalasia, diagnosed by established methods(contrast fluoroscopy, manometry, esophagogastroduodenoscopy(EGD)) and age greater than 18 years were included.||days||Standard Deviation|Mean
694141|NCT01405469|Secondary|Duration Time Procedure|duration time of POEM procedures in minutes|procedure|Pilot study group to evaluate feasibility and safety of POEM procedure before initiating studies evaluating long-term efficacy.Patients with primary achalasia, diagnosed by established methods(contrast fluoroscopy, manometry, esophagogastroduodenoscopy(EGD)) and age greater than 18 years were included.||minutes||Standard Deviation|Mean
694142|NCT01405469|Secondary|Medication 3 Months After POEM|proton pump inhibitor (PPI) use at 3 months after POEM procedure|3 months|||participants|||Number
694143|NCT01405469|Secondary|Number of Participants With Procedure-related Adverse Events|procedure-related adverse events per protocol|procedure to 3 months post procedure|||Participants|||Count of Participants
694144|NCT01405469|Primary|Treatment Success Defined as Symptom Relief 3 Months After Treatment Based on an Eckhardt Score ≤ 3|"eckhardt score is a score to evaluate achalasia discomfort in patients. Patients are being interrogated for dysphagia, regurgitation, and retrosternal pain , correlated with the time frame of occurrence. with every meal giving 3 points, daily (2 points), sometimes (1 Point) or no (0 Points), as well as weight loss,(>10 kg= 3 points, 5-10 kg=2 points, 0-5 kg=1 point, None=0 points. Scale range is from 0 Points (no achalasia) up to 12 points for the worst achalasia symptoms."|3 months after treatment|Pilot study group to evaluate feasibility and safety of POEM procedure before initiating studies evaluating long-term efficacy.Patients with primary achalasia, diagnosed by established methods(contrast fluoroscopy, manometry, esophagogastroduodenoscopy(EGD)) and age greater than 18 years were included.||Eckardt Score||Standard Deviation|Mean
694145|NCT01405469|Secondary|Number of Participants With Reflux Symptoms|Number of Participants with Reflux Symptoms during procedure, and 3 and 6 months, and 1, 2 and 5 years after treatment|during procedure, and 3 and 6 months, and 1, 2 and 5 years after treatment|||participants|||Number
694146|NCT01405469|Secondary|mmHg of the Lower Esophageal Sphincter 3 Months After POEM Procedure|esophageal manometry is done 3 months after POEM procedure to evaluate resting lower esophageal sphincter pressure|manometry at 3 month after therapy|Pilot study group to evaluate feasibility and safety of POEM procedure before initiating studies evaluating long-term efficacy.Patients with primary achalasia, diagnosed by established methods(contrast fluoroscopy, manometry, esophagogastroduodenoscopy(EGD)) and age greater than 18 years were included.||mmHg||Standard Deviation|Mean
694147|NCT01405313|Secondary|Oxygen Desaturation Index (ODI)|Oxygen desaturation index based on SpO2 measurement of number of dips (number of times per hour of sleep that SpO2 Drops by at least 3% below the basic value) will be recorded, analysed and reported.|One night|||Events per hour||Standard Deviation|Mean
694148|NCT01405313|Primary|Apnea/Hypopnea Index (AHI)|Physiological sleep signals including pulse oximetry (SpO2), respiratory effort and nasal flow, will be recorded, analysed and reported in the form of an index per hour of sleep. Apnea-Hypopnea Index is calculated counting all apneas (reduction of respiratory flow by >90% for at least 10 seconds) plus all hypopneas (reduction of respiratory flow by >30% for at least 10 seconds with a 4% SpO2 reduction) divided by hours of sleep.|One night|||Events per hour||Standard Deviation|Mean
694150|NCT01405027|Secondary|Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions)|"Determination of the quality of life for HCV patients treated with boceprevir, peginterferon and ribavirin at community sites and at HCEEs.
Patient scores per subscale (8) were obtained by subtracting the lowest possible raw score from the actual raw score x 100, divided by the lowest possible raw score subtracted from the highest possible raw score. Subscale scores were averaged (with standard deviation) for Group A and Group B. Composite Scores are standardized to the general US population having a mean of 50 and a standard deviation of 10. Higher score = improved quality of life."|Baseline, end of treatment, follow-up week 24|The Quality of Life scores are derived from the responses from subjects who completed questionnaires at protocol-scheduled timepoints.||score||Standard Deviation|Mean
694151|NCT01405027|Secondary|Determination of the Rate of Sustained Viral Response (SVR) for HCV Patients Treated With Boceprevir, Peginterferon and Ribavirin at Community Sites and at HCEEs.|Rate of SVR was defined as the percentage of participants with HCV-RNA undetectable at follow-up Week 24. All percentages were based on the total number of participants originally randomized/enrolled to that particular arm.|Follow-up week 24|Follow-up SVR includes data collected 10 weeks or greater from last treatment.||percentage of participants|||Number
694152|NCT01405027|Secondary|Drug Exposure|Total number of patients receiving treatment over specified time intervals.|End of treatment up to treatment week 48|||participants|||Number
694153|NCT01405027|Primary|Treatment Duration Compliance Rate|The primary objective will be to define treatment duration compliance rate (calculated as the actual treatment duration in weeks divided by the expected duration in weeks) based on individual patient treatment goals as defined in the OPTIMAL protocol for HCV patients treated with boceprevir, peginterferon and ribavirin for up to 48 weeks. Rates will be reported for HCEEs (Group A) and community sites enrolled in the Program (Group B).|End of treatment up to treatment week 48|Population analyzed represents patients who had a PCR at treatment weeks where expected duration of treatment could have been determined. Subjects who discontinued the study due to Treatment Futility were considered to have 100% treatment duration compliance.||Percentage of compliance||95% Confidence Interval|Mean
694154|NCT01404988|Secondary|Self-reported Medication Adherence|Assessed using Morisky medication-taking scale. Higher score corresponds to worse adherence.|6 months from baseline|||participants|||Number
694155|NCT01404988|Secondary|Adherence to Beta Blockers|"Refill compliance is an objective measurement of medication adherence that utilizes pharmacy records to assess the proportion of time a patient has medication available to take. At the original release of the medication, and each subsequent refill, individuals are given enough medication to last a set number of days. This number is referred to as the Days Supply and can be calculated by dividing the number of pills prescribed by the number of pills taken per day. To calculate compliance, the Days Supply is subtracted by the number of days between Actual Refill dates, a time span referred to as the Days Passed. If the Days Passed exceeds the Days Supply the absolute value of the difference represents the number of days the individual was non-adherent. This absolute value is referred to as a Gap. The sum of the Gaps/total number of days passed between the original release of the medication and the final recorded refill date represents non-compliance over that period of time."|6 months from baseline|||proportion of refill compliance||Inter-Quartile Range|Median
694156|NCT01404988|Secondary|Adherence to ACE Inhibitors and ARB|"Refill compliance is an objective measurement of medication adherence that utilizes pharmacy records to assess the proportion of time a patient has medication available to take. At the original release of the medication, and each subsequent refill, individuals are given enough medication to last a set number of days. This number is referred to as the Days Supply and can be calculated by dividing the number of pills prescribed by the number of pills taken per day. To calculate compliance, the Days Supply is subtracted by the number of days between Actual Refill dates, a time span referred to as the Days Passed. If the Days Passed exceeds the Days Supply the absolute value of the difference represents the number of days the individual was non-adherent. This absolute value is referred to as a Gap. The sum of the Gaps/total number of days passed between the original release of the medication and the final recorded refill date represents non-compliance over that period of time."|6 months after baseline|||proportion of refill compliance||Inter-Quartile Range|Median
694157|NCT01404988|Primary|Medication Adherence (Refill Compliance for All HF Medications)|"Refill compliance is an objective measurement of medication adherence that utilizes pharmacy records to assess the proportion of time a patient has medication available to take. At the original release of the medication, and each subsequent refill, individuals are given enough medication to last a set number of days. This number is referred to as the Days Supply and can be calculated by dividing the number of pills prescribed by the number of pills taken per day. To calculate compliance, the Days Supply is subtracted by the number of days between Actual Refill dates, a time span referred to as the Days Passed. If the Days Passed exceeds the Days Supply the absolute value of the difference represents the number of days the individual was non-adherent. This absolute value is referred to as a Gap. The sum of the Gaps/total number of days passed between the original release of the medication and the final recorded refill date represents non-compliance over that period of time."|6 months from baseline visit|||proportion of refill compliance||Inter-Quartile Range|Median
694158|NCT01404936|Primary|Participants' Response|Complete Response (CR): Disappearance of all clinical evidence of active tumors for a minimum of 8 weeks. Partial Response (PR): 50% or greater decrease in sum of products all measured lesions persisting for at least 4 weeks. No Change: Steady state or change of +/- 25% of tumor size and no progression for minimum of 8 weeks with no appearance of new lesions. Progressive Disease: > 25 % increase in size of any measurable lesion or appearance of significant new lesions.|After 6 courses (3 months)|Two patients did not complete therapy; however, they were included in the intent-to-treat analysis. One patient was censored at the last follow-up date since no events had occurred.||participants|||Number
694159|NCT01404923|Primary|Percentage of Improvement of the Total IBSQoL Scores|Improvement of the total IBSQoL scores from baseline to month 6 calculated in percentage|Baseline and 6 Months|The efficacy population included all patients with a calculable IBSQoL score at baseline and at lesat one of the following visit, i.e 173 and 167 patients, respectively in Meteospasmyl and standard of care group.||% of improvement of IBSQoL total scores||Standard Deviation|Mean
694456|NCT01401153|Primary|Tonic Alertness (Mean Reaction Time)|Mean reaction time to response to a simple visual stimulus without a preceding warning signal|Participants were tested twice with one week wash out (1h after having/skipping lunch)|Complete case analysis||Milliseconds||Inter-Quartile Range|Median
694160|NCT01404923|Primary|Change From Baseline in Irritable Bowel Syndrome Quality Of Life Overall Score|Irritable Bowel Syndrome Quality of Life total score (IBSQoL) is a health-related Quality of Life (QoL) disease-specific scale adapted for French patients. Total score ranges from minimum=0 to maximum = 100 representing the best outcome.|Baseline and 6 months|The efficacy population included all patients with a calculable IBSQoL score at baseline and at least one of the following visit, i.e 173 and 167 patients, respectively in Meteospasmyl and standard of care group.||units on a scale||Standard Error|Mean
694161|NCT01404832|Secondary|Number of Patients Who Had Resolution of Heartburn With Lansoprazole|Resolution of heartburn defined as >50% improvement in symptoms|After 8 weeks of treatment|||participants|||Number
694162|NCT01404832|Primary|Number of Participants With Eosinophilic Esophagitis||8 weeks|||participants|||Number
694163|NCT01404650|Secondary|Number of Patients With Adverse Events as a Measure of Safety and Tolerability|Worst toxicity grades per patient were tabulated for select adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v 4.0|Days 1, 8 and 15 of each 21-day cycle plus 30 days after treatment discontinuation.|All participants who received at least one dose of study drug.||participants|||Number
694164|NCT01404650|Secondary|Overall Survival (OS)|Evidence of survival was obtained by clinic visit or telephone contact from the time of first dose until death from any cause.|Every 3 months until patient death or lost to follow-up, for up to 4 years.|All 25 patients who received treatment were included in the analysis of overall survival.||months||95% Confidence Interval|Median
694165|NCT01404650|Secondary|Response Rate (RR)|Defined as the proportion of complete and partial responses, assessed per RECIST v1.1. Complete response (CR) defined as a disappearance of all lesions; partial response (PR) defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking the baseline sum LD as reference. Stable Disease (SD) defined as neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for progressive disease, taking as reference the smallest (nadir) sum LD since start of treatment.|At 6 and 12 weeks then every 9 weeks thereafter until progressive disease or intolerable toxicity, for up to 4 years.|Of 25 patients enrolled, 4 patients were not evaluable for response due to treatment discontinuation prior to first disease evaluation.||percentage of participants|||Number
694166|NCT01404650|Primary|Progression-free Survival (PFS)|Measured from time of randomization until objective tumor progression or death; assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. Progressive disease (PD) defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest (nadir) sum since the treatment started, or the appearance of one or more new lesions.|At 6 and 12 weeks then every 9 weeks thereafter until progression or intolerable toxicity, up to 4 years.|||months||95% Confidence Interval|Median
694167|NCT01404611|Primary|Time to Cessation of Otorrhea||From baseline until the end of the study (up to 22 days)|||days||95% Confidence Interval|Median
694168|NCT01404572|Secondary|Number of Participants With Clinically Relevant Changes in Vital Signs||Study Day 1|All participants who tasted at least 1 dose of atazanavir. No postdose clinical laboratory assessments were conducted because no participants swallowed any treatment blends.|||||
694169|NCT01404572|Secondary|Number of Participants Who Died and With Adverse Events (AEs) and Serious Adverse Events (SAEs)||Study Day 1|All participants who tasted at least 1 dose of atazanavir||Participants|||Number
694170|NCT01404572|Secondary|Number of Participants With Abnormal Findings on Electrocardiograms||Study Day 1|All participants who tasted at least 1 dose of atazanavir. No postdose clinical laboratory assessments were conducted because no participants swallowed any treatment blends.|||||
694171|NCT01404572|Secondary|Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests||Study Day 1|All participants who tasted at least 1 dose of atazanavir. No postdose clinical laboratory assessments were conducted because no participants swallowed any treatment blends.|||||
694172|NCT01404572|Primary|Mean Scores on a Subjective Sweet Intensity Scale for Current and New Powder for Oral Use (POU) Formulations of Atazanavir|Tasting atazanavir (15 mg, administered as a 5 mL oral suspension) was defined as taking the sample into the mouth, swishing it across the tongue for approximately 30 seconds without swallowing, and then spitting it out. Immediately after tasting each treatment, participants scored the treatments for sweetness using a subjective sweet intensity scoring system: 0=not sweet, 1=mildly sweet, 2=moderately sweet, 3=very sweet. Participants were permitted to select a whole or half score number (for example, 1.5) between the minimum score of 0 and the maximum score of 3.0. The higher the score, the greater the sweetness.|Study Day 1|All participants who tasted at least 1 dose of atazanavir||Units on a scale||Standard Deviation|Mean
694173|NCT01404572|Secondary|Mean Palatability Score for Current and New Powder for Oral Use (POU) Formulations of Atazanavir|Overall palatability was scored on a scale of 1 through 5, with 1 being least palatable and 5 being most palatable. Only whole score numbers were accepted.|Study Day 1|All participants who tasted at least 1 dose of atazanavir||Units on a scale||Standard Deviation|Mean
694174|NCT01404572|Secondary|Median Palatability Score for Current and New Powder for Oral Use Formulations of Atazanavir|Overall palatability was scored on a scale of 1 through 5, with 1 being least palatable and 5 being most palatable. Only whole score numbers were accepted.|Study Day 1|All participants who tasted at least 1 dose of atazanavir||Units on a scale||Full Range|Median
694175|NCT01404572|Primary|Median Scores on a Subjective Sweet Intensity Scale for Current and New Powder for Oral Use (POU) Formulations of Atazanavir|Tasting atazanavir (15 mg, administered as a 5 mL oral suspension) was defined as taking the sample into the mouth, swishing it across the tongue for approximately 30 seconds without swallowing, and then spitting it out. Immediately after tasting each treatment, participants scored the treatments for sweetness using a subjective sweet intensity scoring system: 0=not sweet, 1=mildly sweet, 2=moderately sweet, 3=very sweet. Participants were permitted to select a whole or half score number (for example, 1.5) between the minimum score of 0 and the maximum score of 3.0. The higher the score, the greater the sweetness.|Study Day 1|All participants who tasted at least 1 dose of atazanavir||Units on a scale||Full Range|Median
694227|NCT01403051|Secondary|The Changes From Baseline in Fasting Total Cholesterol to Weeks 24 and 48|Fasting total cholesterol changes from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively).|Weeks 0, 24 and 48|"Included all available data regardless of treatment change/discontinuation, but was limited to eligible subjects who had both baseline and follow-up data.
n=74 and 80 for changes at week 24, n=68 and 73 for changes at week 48."||mg/dL||Inter-Quartile Range|Median
694176|NCT01404559|Primary|Bioenergetics Between Feet Components 21 Days After Fitting Prostheses|Measures of energy expenditure while walking on a treadmill were measured. Expired gas (e.g. oxygen and carbon dioxide) are breathed into a face mask worn by participants. The mask contains sensors to detect the levels of the respective gas. Oxygen uptake is correlated with effort to ambulate and therefore, the more oxygen consumed during walking, the more difficult the bout of activity. Thus, if one prosthetic foot requires the consumption of more or less oxygen than other feet, then this is an indicator of the relative difficulty of walking with that particular foot condition.|21 days total (7days per prosthetic foot condition)|||ml O2/kg/min||Standard Deviation|Mean
694177|NCT01404559|Primary|Obstacle Course Completion Time|Laser timing lights were used to measure time necessary to complete a 17 task obstacle course. Participants trigger the laser timing lights when they run past them and the times are recorded in a laptop computer. Laser lights are set up in pairs at the beginning and end of the obstacle course.|21 days total (7days per prosthetic foot condition)|||seconds||Standard Deviation|Mean
694178|NCT01404429|Secondary|Proportion Who Withdrew Due to Intolerance||3 months|||participants|||Number
694179|NCT01404429|Secondary|Proportion Requiring Stoppage/Decrease/Inability to Hike MTX Due to Cytopenia or Transaminitis (SGOT or SGPT More Than 80IU)||3 months||||||
694180|NCT01404429|Secondary|Proportion of Patients Who Withdrew Because of Any Cause||3 months|||participants|||Number
694181|NCT01404429|Primary|Patients With Good Response (Final DAS28-3 Less Than 3.2 and Fall More Than 1.2)||3 months|||participants|||Number
694182|NCT01404429|Primary|Mean Change in the DAS28-3 (Disease Activity Score Using 28 Joints and Using 3 Variables) - Difference Between This Score at 12 Weeks and This Score at Baseline|DAS28-3 is disease activity score using 28 joints and using 3 variables (tender and swollen joint count for 28 joints and ESR(westergren 1st hour) It ranges from 0 to 9.3 where a lower value implies lower disease activity|12 weeks|||units on a scale||Standard Deviation|Mean
694183|NCT01404260|Primary|Progression Free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or progression in existing non-target lesions,or the appearance of one or more new lesions .|The evaluation of disease is demanded every two months for the patients receiving maintenance use of Gefitinib or patients in observation after chemotherapy,until disease progression occured|Efficacy analysis, including PFS will be based on intent to treat (ITT) population.. ITT population includes all the randomised patients who receive at least one dose of study treatment with at least one baseline data of volume of plaque and at least one data after treatment.||months||95% Confidence Interval|Median
694184|NCT01404234|Secondary|Adverse Event Rates Adjusted for Study Duration|Adverse events occurring in ≥ 5% of participants adjusted for study duration were summarized. The adjustment was made by using a standardized rate calculated as the sum of study duration across patients divided by 28 for the total number of patient months. Rate calculations presented are the number of adverse events (AEs) per patient month.|Baseline to Day 168|Full Analysis Set||AEs (per patient month)|||Number
694185|NCT01404234|Secondary|Percentage of Participants With Study-drug Induced Bronchospasm|Study-drug induced bronchospasm (airway reactivity) was assessed at the baseline visit as the percent change in FEV1 from the pretreatment measurement to 30 minutes following treatment for subjects ≥ 6 years or as from the Investigator's assessment for subjects < 6 years.|Pretreatment at Baseline to 30 minutes following treatment|Full Analysis Set||percentage of participants|||Number
694186|NCT01404234|Secondary|Time to Pulmonary Exacerbation|The median days to first pulmonary exacerbation was summarized using Kaplan-Meier (KM) summary statistics.|Baseline to Day 168|Full Analysis Set||days||95% Confidence Interval|Median
694187|NCT01404234|Secondary|Percentage of Participants With Pulmonary Exacerbations|Pulmonary exacerbations were defined as respiratory hospitalizations or discrete courses of non-study IV/inhaled antipseudomonal antibiotics. Use of oral antibiotics alone for respiratory signs or symptoms was considered to be representative of milder clinical events and, therefore, was not included in the definition of pulmonary exacerbations.|Baseline to Day 168|Full Analysis Set||percentage of participants|||Number
694188|NCT01404234|Secondary|Number of Days Participants Were Hospitalized Due to a Respiratory Event|The average number of days hospitalized due to a respiratory event, among the 11 participants who were hospitalized for respiratory event, was reported.|Baseline to Day 168|Full Analysis Set||days||Standard Deviation|Mean
694189|NCT01404234|Secondary|Percentage of Participants Hospitalized at Least Once Due to a Respiratory Event||Baseline to Day 168|Full Analysis Set||percentage of participants|||Number
694190|NCT01404234|Secondary|Percentage of Participants Who Used Additional (Non-study) Antipseudomonal Antibiotics|The percentage of participants who used additional (non-study) antipseudomonal antibiotics (IV, inhaled, oral, IV/inhaled, IV/inhaled/oral) was summarized (number and percent) for all subjects.|Baseline to Day 168|Full Analysis Set||percentage of participants|||Number
694191|NCT01404234|Secondary|Change in Pseudomonas Aeruginosa (PA) Sputum Density|The change in PA sputum density (log10 colony-forming units per gram [cfu/g]) was assessed at the end of each 28-day AZLI treatment course.|Baseline to Day 28, 84, and 140|Participants in the Full Analysis Set ≥ 6 years of age were analyzed.||log10 CFU/g||Standard Deviation|Mean
694192|NCT01404234|Secondary|Change From Baseline in CFQ-R Respiratory Symptoms Scale (RSS) Score in Subjects Aged ≥ 6 Years|"The change in CFQ-R RSS score was assessed at the end of each 28-day AZLI treatment course.
The range of scores (units) was 0 to 100 with higher scores indicating fewer symptoms."|Baseline to Day 28, 84, and 140|Participants in the Full Analysis Set ≥ 6 years of age were analyzed.||units on a scale||Standard Deviation|Mean
694193|NCT01404234|Secondary|Change From Baseline in FEV1 % Predicted in Subjects Aged ≥ 6 Years|"The change in FEV1 % predicted was assessed at the end of each 28-day AZLI treatment course.
FEV1 % predicted is defined as FEV1 of the patient divided by the average FEV1 in the population for any person of similar age, sex, race, and body composition."|Baseline to Day 28, 84, and 140|Participants in the Full Analysis Set ≥ 6 years of age were analyzed.||percentage of FEV1 % predicted||Standard Deviation|Mean
694283|NCT01402869|Secondary|Time to Peak Methemoglobin Blood Levels|The length of time between the administration of local anesthetic (Prilocaine and Lidocaine Groups) or start of restorative dental procedures (No local anesthetic Group) and the time at which the maximum methemoglobin blood level is observed.|Measured at 10 second intervals during dental treatment for an average of 2 hours|per protocol||minutes||Standard Deviation|Mean
694194|NCT01404234|Primary|Percentage of Participants Who Discontinued Study Drug Due to Safety or Tolerability Reasons|Participants who discontinued study drug due to safety or tolerability reasons were defined as those with “Adverse Event (AE)/Safety or Tolerability” on the Study Drug Completion electronic case report form as the reason for early discontinuation. The 95% confidence interval (CI) was calculated using the exact binomial method.|Baseline to Day 168|Participants in the Full Analysis Set (enrolled and received at least 1 dose of study medication) who completed the study or discontinued study drug due to safety or tolerability reasons were analyzed. Two participants voluntarily withdrew from the study prior to completion (not due to AEs/safety or tolerability reasons).||percentage of participants||95% Confidence Interval|Number
694195|NCT01404208|Secondary|Clinical Global Impression-Severity (CGI-Severity)|The Clinical Global Impression-Severity is a 7-point clinician rating of illness severity, with a score of 0 indicating no illness and a score of 6 indicating extremely severe symptoms. Because the secondary outcome was the change in score from randomization to post treatment, a more negative score indicates a greater reduction in symptom severity.|Change from Randomization Point to Post Treatment|||Change in score from randomization||Standard Deviation|Mean
694196|NCT01404208|Primary|Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)|The CY-BOCS is a measure of severity of OCD symptoms, including interference, time spent on thoughts or behaviors, distress, resistance, etc. The CY-BOCS is measured from 0 to 40, with larger values indicating more severe symptoms. Our outcome measure was the difference between the post treatment and randomization scores. When those values are negative, it indicates a reduction in symptom severity.|Change from Score at Randomization to Post Treatment|||Change in score from randomization||Standard Deviation|Mean
694197|NCT01404078|Secondary|Blood Pressure Reduction and Lipid Lowering in Type 2 Diabetics||8 weeks||||||
694198|NCT01404078|Primary|Tolerability of a Double Dose of Half Strength Polycap||8 weeks||||||
694199|NCT01404078|Primary|BLOOD PRESSURE LIPIDS|Amongst patients with cardiovascular disease or type 2 diabetes, the study aims to test the safety and efficacy of giving double dose of polycap versus a single dose of polycap for 8 weeks; efficacy to lower blood pressure and elevated lipids and safety assessed as difference with tolerance to double dose of polycap compared to a single dose.|8 weeks|||mmHG||95% Confidence Interval|Mean
694200|NCT01404039|Primary|Change in Motor Cortex Excitability MEP Amplitude|"We aim to assess the effects of the intervention (ML, SL, OT and MI) on motor cortex excitability as measured by the change in motor evoked potential (using transcranial magnetic stimulation) before and after the given intervention.
For ML: MEP will be measured before and after each ML sessions in the same subject (crossover design - ML sighted/MLblind/ML control).
For SL: MEP will be measured before and after the treatment session in the each groups (parallel design - 1 session per group).
For OT: MEP will be measured before and after the treatment session in the each groups (parallel - 1 session per group).
For MI: MEP will be measured before and after the treatment session in the each groups (parallel design - 1 session per group)."|after each intervention|"ML: crossover design - ML sighted/MLblind/ML control. 15 patients were enrolled, but one participant dropped-out after the first intervention - participants with available data: 14.
SL: parallel design - SL sighted/SLblind/Sactivation/SLcontrol. OT: parallel design - OT real and OT control. MI: parallel design - MI real and MI control."||microV||Standard Deviation|Mean
694201|NCT01403987|Secondary|Readmission and Mortality Rates|Percentage of patients in each arm that were either readmitted within 30 days or died within 90 days (ie a combined endpoint of either/or readmission or death)|18 months|||percentage of patients|||Number
694202|NCT01403987|Secondary|Improvement in Guideline Adherence|Improvement in adherence to AASLD guidelines is summarized as yes or no improvement based on investigator chart review performed prior to and after the intervention. This is not a measure of resident reporting adherence but rather investigator interpretation of patient care and whether care was in line with published guidelines.|18 months|||percentage of participants|||Number
694203|NCT01403987|Primary|Score Out of Total Possible 25 on a Likert Scale.|"Primary outcome is quantified by summation of Likert scale responses to five questions assessing for comfort level in caring for and managing inpatients with ascites. The scale ranges from strongly disagree, which is assigned a value of 1, to strongly agree, assigned a value of 5. The summation scores will therefore range from 5 to 25 points out of a total of 25 possible points. The post-intervention scores will be compared between groups using a multiple regression model with terms for treatment, baseline summary scores, and other baseline demographic variables as needed."|6 months|Those who provided both baseline and follow up surveys||units on a Likert scale (maximum is 25)||Standard Deviation|Mean
694204|NCT01403805|Other Pre-specified|Died Before Oral Care Starting|Number of resident died before the start of oral care|This participant was died before treatment, Day 1|"This participant was determined as Not Completed due to Died before oral care starting. We excluded this participant from analysis for outcome measure."||participants|||Number
694205|NCT01403805|Other Pre-specified|Reject Vaccine|Number of resident to reject vaccine|These participants rejected vaccine before treatment, Day 1|"These participants were determined as Not Completed due to Reject vaccine. We excluded these participants from analysis for outcome measure."||participants|||Number
694206|NCT01403805|Other Pre-specified|Reject Oral Care|Number of resident to reject oral care|This participant rejected oral care before treatment, Day 1|"This participant was determined as Not Completed due to Reject oral care. We excluded this participant from analysis for outcome measure."||participants|||Number
694207|NCT01403805|Other Pre-specified|Leaving Nursing Home|Numer of resident for leaving nursing home|These participants were followed for the duration of nursing home stay, an average of 22 weeks.|"These participants were determined as Not Completed due to Leaving nursing home. We excluded these participants from analysis for outcome measure."||participants|||Number
694208|NCT01403805|Secondary|Death From Pneumonia|Number of participants for the death from pneumonia|1 year|||participants|||Number
694209|NCT01403805|Primary|Number of Participants With Pneumonia|Number of Participants with Pneumonia sufferers|1 year|||participants|||Number
694228|NCT01403051|Secondary|The Changes From Baseline in HOMA-IR to Weeks 24 and 48|Homeostatic model assessment insulin resistance (HOMA-IR) changes from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively).|Weeks 0, 24 and 48|"Included all available data regardless of treatment change/discontinuation, but was limited to eligible subjects who had both baseline and follow-up data.
n=69 and 73 for changes at week 24, n=64 and 69 for changes at week 48."||HOMA-IR||Inter-Quartile Range|Median
694210|NCT01403441|Secondary|Delis-Kaplan Executive Function System (D-KEFS) Composite Score|D-KEFS is a neurocognitive assessment of executive function. The composite score is derived from scores on tests that include Trails A, Color Word Interference, Verbal Fluency, Sorting, WAIS III Digit Span, and CVLT II Long Delay Free Recall. The scores are reported as deviation from a mean of 10, with a standard deviation of 3. A score of 7 is one standard deviation below the mean, while a score of 13 is 1 standard deviation above the mean. Higher numeric outcomes reflect better performance on the test, lower values reflect poorer performance. Results reflect scores at baseline, and 12 month observation period following Cyberknife System|Baseline and 12 months|||units on a scale||Standard Deviation|Mean
694211|NCT01403441|Secondary|Clinical Global Impression - Severity (CGI-S) at Baseline and 12 Months|The CGI-S assess the overall severity of depression over the 12 month observation period following Cyberknife System. It is rated from 1 (well or remitted) to 7 (severely ill, among the most depressed).|Baseline and 12 months|||units on a scale||Standard Deviation|Mean
694212|NCT01403441|Secondary|Hamilton Depression Rating Scale (HDRS) - 17 Item|The HDRS is a rating scale measures the severity of depressive symptoms. The scale consists of 17 symptoms with severity anchors that are scored from 0 to 4. The maximum score (most severe depression) is 68, the lowest (no depressive symptoms) is 0.|Baseline and 12 months|Patients with Bipolar disorder in the depressive phase that have not responded to available treatments||units on a scale||Standard Deviation|Mean
694213|NCT01403441|Primary|Serious Adverse Event|An event that required hospitalization due to an unanticipated worsening of the subjects bipolar disorder.|Baseline and 12 months.|Patients with bipolar disorder in the depressive phase who have not responded to any available treatment||event|||Number
694214|NCT01403376|Secondary|Immunoglobulin Levels||pre vaccination (baseline) and 28 days post vaccination|Per-protocol population as previously defined||g/L||Standard Deviation|Mean
694215|NCT01403376|Secondary|Geometric Mean of Titers (GMT) Ratio Post/Pre Vaccination||pre vaccination (baseline) and 28 days post vaccination|Per-protocol population as previously defined||ratio post/pre vaccination||90% Confidence Interval|Geometric Mean
694216|NCT01403376|Secondary|Percentage of Participants With 4 Fold or More Increase in Antibody Titer at 28 Days Post Vaccination|Percentages of participants with an increase from baseline of 4-fold or more in antibody titers and 90% CIs using normal approximation were calculated for each strain and treatment group.|pre vaccination (baseline) and 28 days post vaccination|Per-protocol population as previously defined||percentage of participants||90% Confidence Interval|Number
694217|NCT01403376|Secondary|Percentage of Participants With 2 Fold or More Increase in Antibody Titer at 28 Days Post Vaccination|Percentages of participants with an increase from baseline of 2-fold or more in antibody titers and 90% CIs using normal approximation were calculated for each strain and treatment group.|pre vaccination (baseline) and 28 days post vaccination|Per-protocol population as previously defined||percentage of participants||90% Confidence Interval|Number
694218|NCT01403376|Primary|Percentage of Participants With Antibody Titer ≥40 at 28 Days Post Vaccination|"For each viral strain (H1N1, H3N2, and B), the antibody titer, level of antibodies in blood sample when exposed to antigen, was calculated as the mean of two replicates. If the titer was below or above the limit of detection, the threshold value was used.
The percentage of participants achieving a titer of 40 or more, as well as the 90% confidence interval (CI) using normal approximation were calculated for each strain and treatment group."|28 days post vaccination|Per-protocol population: Enrolled and vaccinated participants with antibody assessments at Day 28, but excluding those with important events/deviations potentially impacting analysis (multiple sclerosis relapse, poor compliance to treatment, interfering concomitant drug). Participants were considered according to the treatment actually received.||percentage of participants||90% Confidence Interval|Number
694219|NCT01403194|Secondary|Change in Level of Lipids||baseline, 3 months|Only one participant returned for the 3 month visit.|||||
694220|NCT01403194|Secondary|Change in Level of Fasting Insulin||baseline, 3 months|Only one participant returned for the 3 month visit.|||||
694221|NCT01403194|Primary|Change in Level of Fasting Glucose||baseline, 3 months|Only one participant returned for the 3 month visit.|||||
694222|NCT01403090|Primary|Safety|Device safety was evaluated on the basis of identification and summarization of the incidence rates of complications and adverse effects.|30 days|||participants|||Number
694223|NCT01403051|Secondary|The Changes From Baseline in iPTH to Weeks 24 and 48|iPTH (Parathyroid Hormone, intact) changes from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively).|Weeks 0, 24 and 48|"Included all available data regardless of treatment change/discontinuation, but was limited to eligible subjects who had both baseline and follow-up data.
n=72 and 77 for changes at week 24, n=66 and 72 for changes at week 48."||pg/mL||Inter-Quartile Range|Median
694224|NCT01403051|Secondary|The Changes From Baseline in CD4 to Weeks 4, 12, 24 and 48|Total CD4 count changes from baseline to weeks 4, 12, 24 and 48 [week 4/12/24/48 - baseline].|Weeks 0, 4, 12, 24 and 48|"Included all available data regardless of treatment change/discontinuation, but was limited to eligible subjects who had both baseline and follow-up data.
n=78 and 86 for changes at week 4, n=77 and 85 for changes at week 4, n=76 and 84 for changes at week 24, n=69 and 80 for changes at week 48."||cells/mm^3||Inter-Quartile Range|Median
694225|NCT01403051|Secondary|The Changes From Baseline in Urinary Phosphate Excretion to Weeks 24 and 48|"Fractional excretion of phosphate changes from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively).
Fractional Excretion of Phosphate (in %) is defined as:
[Urine Phosphate x Serum Creatinine] / [Urine Creatinine x Serum Phosphate] x 100%"|Weeks 0, 24 and 48|"Included all available data regardless of treatment change/discontinuation, but was limited to eligible subjects who had both baseline and follow-up data.
n=58 and 70 for changes at week 24, n=59 and 69 for changes at week 48."||percent||Inter-Quartile Range|Median
694226|NCT01403051|Secondary|The Changes From Baseline in Fasting LDL to Weeks 24 and 48|Fasting LDL cholesterol changes from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively).|Weeks 0, 24 and 48|"Included all available data regardless of treatment change/discontinuation, but was limited to eligible subjects who had both baseline and follow-up data.
n=70 and 72 for changes at week 24, n=65 and 67 for changes at week 48."||mg/dL||Inter-Quartile Range|Median
694284|NCT01402869|Primary|Peak Methemoglobin Blood Levels|The maximum percentage of methemoglobin in blood|Measured at 10 second intervals during dental treatment for an average of 2 hours|Per protocol||percentage of methemoglobin in blood||Standard Deviation|Mean
694229|NCT01403051|Secondary|The Changes From Baseline in CTX to Weeks 24 and 48|CTX (marker of bone resorption) changes from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively).|Weeks 0, 24 and 48|"Included all available data regardless of treatment change/discontinuation, but was limited to eligible subjects who had both baseline and follow-up data.
n=72 and 77 for changes at week 24, n=66 and 72 for changes at week 48."||ng/mL||Inter-Quartile Range|Median
694230|NCT01403051|Secondary|The Changes From Baseline in P1NP to Weeks 24 and 48|P1NP (marker of bone formation) changes from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively).|Weeks 0, 24 and 48|"Included all available data regardless of treatment change/discontinuation, but was limited to eligible subjects who had both baseline and follow-up data.
n=72 and 77 for changes at week 24, n=66 and 72 for changes at week 48."||ng/mL||Inter-Quartile Range|Median
694231|NCT01403051|Secondary|The Changes From Baseline in sCD14 to Weeks 24 and 48|Soluble cluster of differentiation 14 (sCD14) changes from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively).|Weeks 0, 24 and 48|"Included all available data regardless of treatment change/discontinuation, but was limited to eligible subjects who had both baseline and follow-up data.
n=68 and 68 for changes at week 24, n=62 and 63 for changes at week 48."||log10 ng/mL||Inter-Quartile Range|Median
694232|NCT01403051|Secondary|The Changes From Baseline in IL-6 to Weeks 24 and 48|Interleukin 6 (IL-6) changes from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively).|Weeks 0, 24 and 48|"Included all available data regardless of treatment change/discontinuation, but was limited to eligible subjects who had both baseline and follow-up data.
n=66 and 68 for changes at week 24, n=58 and 62 for changes at week 48."||log10 pg/mL||Inter-Quartile Range|Median
694233|NCT01403051|Secondary|The Change in Total 25-OH Vitamin D Level From Baseline to Weeks 24 and 48|"Changes in total 25-OH vitamin D from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively).
Total 25-OH vitamin D is the sum of vitamin 25-OH D2 and D3 levels. All 25-OH vitamin D2 or D3 values below the lower limit of 1.25 ng/mL were imputed to 0 ng/mL"|Weeks 0, 24, and 48|"Included all available data regardless of treatment change/discontinuation, but was limited to eligible subjects who had both baseline and follow-up data.
n=71 and 74 for changes at week 24, n=65 and 68 for changes at week 48."||ng/mL||Inter-Quartile Range|Median
694234|NCT01403051|Secondary|Number of Participants With Primary Adverse Events|Primary adverse events include all SAEs defined according to ICH guidelines and targeted protocol events, which include all diagnoses of hypercalcemia, hypophoatemia, and nephrolithiasis as well as signs and symptoms grade 2 or higher that may be associated with hypercalcemia and all laboratory toxicities grade 2 or higher defined by the 2004 DAIDS grading table|From first study treatment to week 48|All enrolled subjects including subjects excluded from efficacy analysis due to eligibility violation.||participants|||Number
694235|NCT01403051|Secondary|The Percent Change From Baseline in Bone Mineral Density (BMD) at Spine|The percent change from baseline to week 48 in bone mineral density (BMD) at spine as measured by DXA scan|Weeks 0 and 48|This analysis is intent-to-treat (ITT) which is limited to eligible subjects who have baseline and week 48 follow-up regardless of treatment change or discontinuation.||percentage change||Inter-Quartile Range|Median
694236|NCT01403051|Primary|The Percent Change From Baseline in Bone Mineral Density (BMD) at Total Hip|The efficacy endpoint is the percent change from baseline to week 48 in bone mineral density (BMD) at total hip (as measured by DXA scan)|Weeks 0 and 48|The primary analysis is intent-to-treat (ITT) which is limited to eligible subjects who have baseline and week 48 follow-up regardless of treatment change or discontinuation.||percentage change||Inter-Quartile Range|Median
694237|NCT01402986|Secondary|Percent Change From Baseline in Peak Expiratory Flow (PEF) at Week 53 at Home|The PEF is a participant’s maximum speed of expiration, as measured with a peak flow meter. Peak flow testing for PEF was performed at home (morning and evening) while sitting or standing prior to using any medication (if needed) for asthma. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Day 1 - Day 7 (Baseline) and Day 365 - Day 371 (Week 53)|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||percentage change||Standard Error|Mean
694238|NCT01402986|Secondary|Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 53 at Home|Pre- and post-bronchodilator FEV1 at home (morning and evening) were measured. FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Day 1 - Day 7 (Baseline) and Day 365 - Day 371 (Week 53)|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||percentage change||Standard Error|Mean
694239|NCT01402986|Secondary|Percent Change From Baseline in Inspiratory Capacity (IC) at Week 53|Pre- and post-bronchodilator IC at clinic visits (morning) were measured. IC was measured by spirometry. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms. Baseline for IC was measured in liters.|Baseline and Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||percentage change in liters||Standard Error|Mean
694240|NCT01402986|Secondary|Percent Change From Baseline in Forced Vital Capacity (FVC) at Week 53|Pre- and post-bronchodilator FVC at clinic visits (morning) were measured. FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms. Baseline for FVC was measured in liters.|Baseline and Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||percentage change in liters||Standard Error|Mean
694241|NCT01402986|Secondary|Percent Change From Baseline in Forced Expiratory Volume in 6 Second (FEV6) at Week 53|Pre- and post-bronchodilator FEV6 at clinic visits (morning) were measured. FEV6 was the maximal volume of air exhaled in the six second of a forced expiration from a position of full inspiration. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms. Baseline for FEV6 was measured in liters.|Baseline and Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||percentage change in liters||Standard Error|Mean
694242|NCT01402986|Secondary|Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 53|Pre- and post-bronchodilator FEV1 at clinic visits (morning) were measured. FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms. Baseline for FEV1 was measured in liters.|Baseline and Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||percentage change in liters||Standard Error|Mean
694243|NCT01402986|Secondary|Change From Baseline in Overall Activity Limitations at Week 53|There were 3 activity limitation questions in the ASMA diary. All activity questions were scored from 0 to 4 and averaged, where the higher score indicated greater limitation. Activity limitation scores were averaged weekly for participants with at least 4 non-missing records each week. The baseline score was calculated from Day -7 to Day -1. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Day -7 - Day -1 (Baseline) and Day 365 - Day 371 (Week 53)|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||units on a scale||Standard Deviation|Mean
694244|NCT01402986|Secondary|Change From Baseline in Percentage of Nighttime Awakening at Week 53|Scores for nighttime awakenings were generated based on the single item (question 5) that had a dichotomous response option (YES/NO). Nighttime awakenings were averaged weekly for participants with at least 4 non-missing records each week. The baseline score was calculated with data from Day -7 to Day -1. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.|Day -7 - Day -1 (Baseline) and Day 365 - Day 371 (Week 53)|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||percentage change||Standard Deviation|Mean
694245|NCT01402986|Secondary|Annual Asthma Exacerbation Rate (AER) by Chronic OCS Use|Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. It was considered resolved 7 days after the last dose of OCS administered (10 days after an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. AER evaluated by subgroup chronic OCS use. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Week 1 up to Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||AER events/person-year||95% Confidence Interval|Number
694246|NCT01402986|Secondary|Annual Asthma Exacerbation Rate (AER) by Atopic Asthma Status|Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. AER was evaluated by subgroup Atopic and Non-atopic asthma status. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Week 1 up to Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||AER events/person-year||95% Confidence Interval|Number
694247|NCT01402986|Secondary|Change From Baseline in Total AQLQ(S) Scores at Week 53 in Subgroups|AQLQ: a 32-item questionnaire evaluating quality of life of participants with asthma including 4 domains (symptoms, activity limitations, emotional function, and environmental stimuli). Participants were asked to recall their experiences during the previous 2 weeks and to score each of the 32 questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score was calculated as the mean response to all questions. The 4 domain scores were the means of the responses to the questions in each of the domains. Overall AQLQ score and 4 domain scores ranged from 7 (no impairment) to 1 (severe impairment). Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Week 1 up to Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||units on a scale||Standard Error|Mean
694248|NCT01402986|Secondary|Change From Baseline in Mean ACQ-6 Scores at Week 53 in Subgroups|Asthma Control Questionnaire (ACQ) is a participant-reported questionnaire to assess the asthma control with 6 items assessing night-time waking, symptoms on waking, activity limitation, shortness of breath, wheeze, and rescue short-acting beta agonist use. Each item was rated on a 7-point Likert scale ranging from 0 (no impairment) to 6 (maximum impairment). Overall ACQ score was the mean of the 6 item scores with a score range of 0 (well controlled) to 6 (extremely poor controlled). Data collected on Day 1 prior to dosing was considered as baseline. Results were reported for overall ACQ score. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Week 1 up to Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||units on a scale||Standard Error|Mean
694249|NCT01402986|Secondary|Percent Change From Baseline in Prebronchodilator FEV1 at Week 53 in Subgroups|Prebronchodilator FEV1 was evaluated by subgroups. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Week 1 up to Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||Percent change||Standard Error|Mean
694285|NCT01402817|Secondary|Volumetric Disease Evaluation|To determine the response rate with Sutent® in patients with plexiform neurofibromas using volumetric analysis of MRI scans|6 months|||percentage of subjects|||Number
694562|NCT01400412|Secondary|Change in CD4 Count From Baseline to Week 24|Change in CD4 count from baseline (week 0) to week 24|Week 0, week 24|Change in total CD4 count is analyzed in the same as-treated population as in the primary as-treated analysis.||cells/mm^3||Inter-Quartile Range|Median
694250|NCT01402986|Secondary|Severe Asthma Exacerbation Rate (AER) by Baseline Peripheral Blood Eosinophil Count|Severe AER was assessed based on AER data up to Week 53. Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. It was considered resolved 7 days after the last dose of OCS administered (10 days after an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. Severe AER was evaluated by subgroup baseline peripheral blood eosinophil count. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Week 1 up to Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||AER events/person-year||95% Confidence Interval|Number
694251|NCT01402986|Secondary|Severe Asthma Exacerbation Rate (AER) by T-helper-2 (Th2) Status|Severe AER was assessed based on AER data up to Week 53. An asthma exacerbation is a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 days. It was considered resolved 7 days after last dose of OCS administered (10 days after injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. Severe AER was evaluated by subgroup Th2 status. Th2-high include participants who had IgE >100 IU/mL and blood eosinophils >=0.14*10^9/Liter. Th2 low would include participants who do not meet Th2 high status. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Week 1 up to Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||AER events/person-year||95% Confidence Interval|Number
694252|NCT01402986|Secondary|Severe Asthma Exacerbation Rate (AER) by Baseline FEV1 Reversibility|Severe AER was assessed based on AER data up to Week 53. Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. It was considered resolved 7 days after the last dose of OCS administered (10 days after an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. Severe AER was evaluated by subgroup FEV1 reversibility. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Week 1 up to Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||AER events/person-year||95% Confidence Interval|Number
694253|NCT01402986|Secondary|Severe Asthma Exacerbation Rate (AER) by Baseline Serum Periostin|Severe AER was assessed based on AER data up to Week 53. Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. It was considered resolved 7 days after the last dose of OCS administered (10 days after an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. Severe AER evaluated by subgroup baseline serum periostin. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Week 1 up to Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||AER events/person-year||95% Confidence Interval|Number
694254|NCT01402986|Secondary|Annual Asthma Exacerbation Rate (AER) by Asthma Exacerbations in the Past Year|Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. It was considered resolved 7 days after the last dose of OCS administered (10 days after an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. AER evaluated by subgroup as asthma exacerbations in the past year. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Week 1 up to Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||AER events/person-year||95% Confidence Interval|Number
694262|NCT01402986|Secondary|Severe Annual Asthma Exacerbation Rate (AER)|Severe annualized AER was assessed based on AER data up to Week 53. Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed or administered by the investigator; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. An asthma exacerbation event was considered resolved 7 days after the last dose of oral corticosteroids is administered (10 days after an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Week 1 up to Week 53|The ITT population included all participants who were randomized into the study.||AER events/person-year||95% Confidence Interval|Number
694255|NCT01402986|Secondary|Annual Asthma Exacerbation Rate (AER) by Baseline FEV1% Predicted|Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. It was considered resolved 7 days after the last dose of OCS administered (10 days after an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. AER was evaluated by subgroup baseline FEV1% predicaed. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Week 1 up to Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||AER events/person-year||95% Confidence Interval|Number
694256|NCT01402986|Secondary|Annual Asthma Exacerbation Rate (AER) by Baseline FEV1 Reversibility|Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. It was considered resolved 7 days after the last dose of OCS administered (10 days after an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. AER evaluated by subgroup baseline FEV1 reversibility >=12% and <12%. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Week 1 up to Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||AER events/person-year||95% Confidence Interval|Number
694257|NCT01402986|Secondary|Annual Asthma Exacerbation Rate (AER) by Baseline Peripheral Blood Eosinophil Count|Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. It was considered resolved 7 days after the last dose of OCS administered (10 days after an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. AER evaluated by subgroups baseline peripheral blood eosinophil counts. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Week 1 up to Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||AER events/person-year||95% Confidence Interval|Number
694258|NCT01402986|Secondary|Annual Asthma Exacerbation Rate (AER) by T-helper-2 (Th2) Status|Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. AER was evaluated by subgroup Th2 status. Th2-high included those participants who had immunoglobulin E (IgE) >100 international unit per milliliter (IU/mL) and blood eosinophils >= 0.14 * 10 power 9 per Liter. Th2 low would include those participants who do not meet Th2 high status. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Week 1 up to Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||AER events/person-year||95% Confidence Interval|Number
694259|NCT01402986|Secondary|Annual Asthma Exacerbation Rate (AER) by Baseline Serum Periostin|Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. It was considered resolved 7 days after the last dose of OCS administered (10 days after an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. AER was evaluated by subgroup baseline serum periostin greater than or equal to (>=) or less than (<) median, >= or < 25th percentile and >= or < 75th percentile. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Week 1 up to Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||AER events/person-year||95% Confidence Interval|Number
694260|NCT01402986|Secondary|Time to First Severe Exacerbation Through Week 53|Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Week 1 up to Week 53|The ITT population included all participants who were randomized into the study.||days||95% Confidence Interval|Median
694261|NCT01402986|Secondary|Time to First Exacerbation Through Week 53|Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Week 1 up to Week 53|The ITT population included all participants who were randomized into the study.||days||95% Confidence Interval|Median
694263|NCT01402986|Secondary|Percentage of Participants With Anti-Drug Antibodies (ADA) to Tralokinumab|Immunogenicity assessment included determination of anti-drug (tralokinumab) antibodies in serum samples. ADA positive was defined as a titer greater than or equal to (>=13) at any point in the study. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Baseline and Week 75|"The PK population included all participants who received at least one dose of tralokinumab and had at least one quantifiable PK observation. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||percentage of participants|||Number
694264|NCT01402986|Secondary|Observed Serum Tralokinumab Concentration at Week 53|Tralokinumab concentrations that were below limit of quantification (LOQ) of the pharmacokinetic (PK) assay (LOQ = 0.500 microgram per milliliter [mcg/mL]) were replaced by LOQ/2 = 0.250 mcg/mL; results were reported to 3 significant figures level of precision. Observed serum tralokinumab concentration at Week 53 was reported.|Week 53|"The PK population included all participants who received at least one dose of tralokinumab and had at least one quantifiable PK observation. Here N signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||microgram per milliliter||Standard Deviation|Mean
694265|NCT01402986|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between administration of study drug and up to Week 75 that were absent before treatment or that worsened relative to pre-treatment state. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Baseline and Week 75|The safety population included all participants who received any investigational product and had safety data available for analysis.||participants|||Number
694266|NCT01402986|Secondary|Change From Baseline in Rescue Medication Use at Week 53|Rescue medication use was collected from 3 questions: daytime use in response to symptoms (question 3), daytime prophylactic use (question 4) and nighttime use (question 7). Rescue medication use questions were first assessed using a dichotomous response option (YES/NO). If the participants reported YES, there was a subsequent question about the number of times rescue medication was used (questions 3a, 4a, and 7a). Daily average scores were summarized each week for all participants with at least 4 non-missing records each week. Days with no reported rescue medication use were represented as 0 and included in the calculation with participants who reported yes and completed questions 3a, 4a and 7a. The baseline scores were calculated from Day -7 to Day -1. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Day -7 - Day -1 (Baseline) and Day 365 - Day 371 (Week 53)|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||use per day||Standard Deviation|Mean
694267|NCT01402986|Secondary|Change From Baseline in Assessing Symptoms of Moderate-to-severe Asthma (ASMA) at Week 53|There were 3 symptom questions in the ASMA diary: daytime frequency (question 1), daytime severity (question 2) and nighttime severity (question 6). All symptom questions were scored from 0 to 4 averaged, where a higher score indicated greater frequency or severity. Daily Asthma symptom scores were averaged weekly for participants with at least 4 non-missing records each week. The baseline score was calculated from Day -7 to Day -1. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.|Day -7 - Day -1 (Baseline) and Day 365 - Day 371 (Week 53)|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||units on a scale||Standard Deviation|Mean
694268|NCT01402986|Secondary|Change From Baseline in European Quality of Life 5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Week 53|The utility-based EQ-5D questionnaire comprises of two parts and provides a generic measure of health for clinical and economic appraisal. The EQ-5D VAS was measured from 0 (worst imaginable health state) to 100 (best imaginable health state). Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Baseline and Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||units on a scale||Standard Error|Mean
694269|NCT01402986|Secondary|Number of Participants With European Quality of Life 5 Dimensions (EQ-5D) Scores at Week 53|The utility-based EQ-5D questionnaire comprises of two parts and provides a generic measure of health for clinical and economic appraisal. The health state valuation was the summary score of mobility, self-care, usual activities, pain/discomfort and anxiety/depression on a 3 category scale (no problem, moderate problem, severe problems) that reflects increasing levels of difficulty. The minimum possible value is 5 (one point for each dimension) and the maximum possible values is 15 (3 points for each dimension). Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Week 53|The ITT population included all participants who were randomized into the study.||participants|||Number
694270|NCT01402986|Secondary|Change From Baseline in Asthma Quality of Life Questionnaire Standardized Version (AQLQ[S]) Score at Week 53|AQLQ: a 32-item questionnaire evaluating quality of life of participants with asthma including 4 domains (symptoms, activity limitations, emotional function, and environmental stimuli). Participants were asked to recall their experiences during the previous 2 weeks and to score each of the 32 questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score was calculated as the mean response to all questions. The 4 domain scores were the means of the responses to the questions in each of the domains. Overall AQLQ score and 4 domain scores ranged from 7 (no impairment) to 1 (severe impairment). Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Baseline and Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||units on a scale||Standard Error|Mean
694271|NCT01402986|Secondary|Change From Baseline in Mean Asthma Control Questionnaire (6-items) (ACQ-6) Score at Week 53|Asthma Control Questionnaire (ACQ) is a participant-reported questionnaire to assess the asthma control with 6 items assessing night-time waking, symptoms on waking, activity limitation, shortness of breath, wheeze, and rescue short-acting beta agonist use. Each item was rated on a 7-point Likert scale ranging from 0 (no impairment) to 6 (maximum impairment). Overall ACQ score was the mean of the 6 item scores with a score range of 0 (well controlled) to 6 (extremely poor controlled). Data collected on Day 1 prior to dosing was considered as baseline. Results were reported for overall ACQ score. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Baseline and Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||units on a scale||Standard Error|Mean
694272|NCT01402986|Secondary|Mean Change From Baseline in Peak Expiratory Flow (PEF) at Week 53 at Home|The PEF is a participant’s maximum speed of expiration, as measured with a peak flow meter. Peak flow testing for PEF was performed at home (morning and evening) while sitting or standing prior to using any medication (if needed) for asthma. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Day 1 - Day 7 (Baseline) and Day 365 - Day 371 (Week 53)|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||liters per minute||Standard Error|Mean
694273|NCT01402986|Secondary|Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 53 at Home|Pre- and post-bronchodilator FEV1 at home (morning and evening) were measured. FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Day 1 - Day 7 (Baseline) and Day 365 - Day 371 (Week 53)|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||liters||Standard Error|Mean
694274|NCT01402986|Secondary|Mean Change From Baseline in Inspiratory Capacity (IC) at Week 53|Pre- and post-bronchodilator IC at clinic visits (morning) were measured. IC was measured by spirometry. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Baseline and Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||liters||Standard Error|Mean
694275|NCT01402986|Secondary|Mean Change From Baseline in Ratio of Forced Expiratory Volume in 1 Second (FEV1)/Forced Vital Capacity (FVC) at Week 53|Pre- and post-bronchodilator FEV1 and FVC at clinic visits (morning) were measured. FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Ratio of FEV1/FVC was analysed. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Baseline and Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||percentage of ratio||Standard Error|Mean
694276|NCT01402986|Secondary|Mean Change From Baseline in Forced Vital Capacity (FVC) at Week 53|Pre- and post-bronchodilator FVC at clinic visits (morning) were measured. FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Baseline and Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||liters||Standard Error|Mean
694277|NCT01402986|Secondary|Mean Change From Baseline in Forced Expiratory Volume in 6 Second (FEV6) at Week 53|Pre- and post-bronchodilator FEV6 at clinic visits (morning) were measured. FEV6 was the maximal volume of air exhaled in the six second of a forced expiration from a position of full inspiration. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Baseline and Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||liters||Standard Error|Mean
694278|NCT01402986|Secondary|Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 53|Pre- and post-bronchodilator FEV1 at clinic visits (morning) were measured. FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Baseline and Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||liters||Standard Error|Mean
694279|NCT01402986|Primary|Annual Asthma Exacerbation Rate (AER)|Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed or administered by the investigator or healthcare provider; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. An asthma exacerbation event was considered resolved 7 days after the last dose of oral corticosteroids (OCS) is administered (10 days after administration of an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Week 1 up to Week 53|The intent-to-treat (ITT) population included all participants who were randomized into the study.||AER events/person-year||95% Confidence Interval|Number
694280|NCT01402947|Primary|Maximum Plasma Concentration (Cmax) of Ciprofloxacin XR|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Assessed over a 24-hour period starting post-dose on day 4|Pharmacokinetic Analysis Set defined as all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Analysis Set defined as subjects who took at least 1 dose of investigational product and had at least 1 postdose safety assessment.||ng/ml||Standard Deviation|Mean
694281|NCT01402947|Primary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) of Ciprofloxacin XR|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Assessed over a 24-hour period starting post-dose on day 4|Pharmacokinetic Analysis Set defined as all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Analysis Set defined as subjects who took at least 1 dose of investigational product and had at least 1 postdose safety assessment.||ng*h/ml||Standard Deviation|Mean
694282|NCT01402869|Secondary|Delta Methemoglobin Blood Level|Change in percentage of methemoglobin in blood from baseline level to peak level|From administration of local anesthetic or start of restorative procedures to time at which maximum methemoglobin blood level was documented during dental treatment for an average of 2 hours|Per protocol||percentage of methemoglobin in blood||Standard Deviation|Mean
694286|NCT01402817|Primary|Disease Response|To estimate the disease control rate (SD, PR, CR) with Sutent® in patients with neurofibromas (NF1). Tumor response criteria are determined by changes in size using all 3 dimensional measurements: width (W), transvers (T) , and length (L) measurements. Partial Response: ≥20% decrease in the sum of the products of the three perpendicular diameters of all target lesions (up to 5), taking as reference the initial baseline measurements.Stable Disease (SD): Neither sufficient decrease in the sum of the products of the three perpendicular diameters of all target lesions to qualify for PR (taking as reference the initial baseline measurements), nor sufficient increase in a single target lesions to qualify for PD, (taking as reference the smallest disease measurement since the treatment started).Progressive Disease (PD): 40% or more increase in the product of perpendicular diameters of ANY target lesion, taking as reference the smallest product observed.|6 months|||percentage of subjects||95% Confidence Interval|Number
694287|NCT01402700|Primary|Major Adverse Event Rate at 9 Months|The Major Adverse Event rate at 9 months is defined as a composite of periprocedural death, in-hospital MI, clinically-driven target lesion revascularization and amputation of the treated limb through 9 months postprocedure.|9 months|||percentage of participants|||Number
694288|NCT01402570|Primary|PROMIS (Patient Reported Outcomes Measurement Information System) Fatigue|Assesses fatigue from mild subjective feelings to an overwhelming, debilitating, and sustained sense of exhaustion that is likely to decrease one’s ability to carry out daily activities, including the ability to work effectively and to function at one’s usual level in family or social roles. Fatigue is divided conceptually into the experience of fatigue (e.g., frequency, duration, and intensity), and the impact of fatigue upon physical, mental and social activities. Scores are on a T-metric with mean of 50 and standard deviation of 10; higher scores indicate greater fatigue.|Baseline, 1 month, 2 months and 3 months|||units on a scale||Standard Deviation|Mean
694289|NCT01402570|Primary|Steps Per Day|Count of steps per day using activity monitor worn on upper arm.|Baseline, 1 month, 2 months and 3 months|||steps per day||Standard Deviation|Mean
694290|NCT01402570|Primary|Sleep Efficiency|The ratio of time asleep over time in bed gathered from sleep diaries completed at bedtime and at awakening. Scores range from 0 to 100%, higher values indicate better sleep efficiency or more time sleeping in bed.|Baseline, 1 month, 2 months and 3 months|||units on a scale||Standard Deviation|Mean
694291|NCT01402570|Primary|PROMIS (Patient Reported Outcomes Measurement Information System) Physical Functioning|Ability to carry out activities that require physical actions, ranging from self-care (activities of daily living) to more complex activities that require a combination of skills, often within a social context. Scores are standardized T-scores with mean of 50 and standard deviation of 10; higher scores indicate better physical function.|Baseline, 1 month, 2 months and 3 months|||units on a scale||Standard Deviation|Mean
694292|NCT01402427|Secondary|Subjective Pain|Analysis of the rates of signiﬁcant pain deﬁned as pain score ≥4 on a semiquantitative scale ranging from 1 to 6.|Subjective pain will be assessed within 1 minute after completion of coronary angiography or intervention.|||participants|||Number
694293|NCT01402427|Secondary|Contrast Volume||The amount of contrast medium will be assessed within 1 minute after completion of coronary angiography or intervention.|||milliliter||Inter-Quartile Range|Median
694294|NCT01402427|Secondary|Fluoroscopic Time||Fluoroscopic time will be assessed within 1 minute after completion of coronary angiography or intervention.|||minutes||Inter-Quartile Range|Median
694295|NCT01402427|Secondary|Procedural Time||Procedural time will be assessed within 1 minute after completion of coronary angiography or intervention.|||minutes||Inter-Quartile Range|Median
694296|NCT01402427|Secondary|Rate of Vasodilator Use||Vasodilator use will be assessed within 1 minute after completion of coronary angiography or intervention.|||participants|||Number
694297|NCT01402427|Secondary|Rate of Code Breaks|Code break: a composite of access site conversion and unplanned use of vasodilators.|Occurrence of code breaking will be assessed within 1 minute after completion of coronary angiography or intervention.|||participants|||Number
694298|NCT01402427|Primary|Rate of Access Site Conversions||Occurrence of access site conversion will be assessed within 1 minute after completion of coronary angiography or intervention.|||participants|||Number
694299|NCT01402284|Secondary|Complete Response (CR) and Minimal Residual Disease Neg (MRDneg) CR Rates at Treatment Intervals With Carfilzomib, Lenalidomide & Dexamethasone (CRd) in New Multiple Myeloma Patients After 8 Cycles of Induction, 1 Year Maintenance, and 2 Years Maintenance|Response is assessed by the International Myeloma Working Group Criteria. MRD is defined by M-spike, plasma cell burden, and abnormal free light chains (FLC). Complete response is negative immunofixation on serum, and urine and disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow. Stringent complete response (sCR) is normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence. Near complete response (nCR) is the absence of myeloma protein on electrophoresis, independent of immunofixation status. Very good partial response (VGPR) is serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100mg per 24h. Overall response rate (ORR) is patients who attained a partial response (PR) (≥50% reduction of serum M-protein and reduction in 24h urinary M-protein) or better (BoR) response.|up to 2 years|*Six patients withdrew from the study, four due to non-compliance and two to continue treatment at another institution. `One patient refused to have a bone marrow biopsy procedure and one patient withdrew due to non-compliance. CR (n=0) after 8 cycles.||percentage of participants||95% Confidence Interval|Number
694300|NCT01402284|Secondary|Rate of Minimal Residual Disease (MRD) by Flow Cytometry|Response is assessed by the International Myeloma Working Group Criteria. Complete response is negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow. MRD is defined by M-spike, plasma cell burden, and abnormal free light chains. Immunophenotyping is performed by multi-parametric flow cytometry.|Day 100|||percentage of participants||95% Confidence Interval|Number
694301|NCT01402284|Secondary|Cluster of Differentiation 138 (CD138) + Plasma Cells Gene Expression Profiling on Pre and Post Carfilzomib Exposure Bone Marrow Samples|Cluster of differentiation 138+ (CD138)+ plasma cells purified from bone marrow aspirates to identify potential markers of early progression. Changes in selected genes were confirmed by quantitative polymerase chain reaction (PCR) if suggested to be related to risk of progression to multiple myeloma.|Cycle 1 Day 1, an average of 28 days ± 2 days|Data were not collected due to lack of financial resources.|||||
694303|NCT01402284|Secondary|Percentage of Responders With Duration of Response (DOR) at 48 Months|Response is assessed by the International Myeloma Working Group Criteria. DOR is measured from the time measurement criteria are met for a partial response or better until first date that recurrent or progressive disease is objectively documented. Partial response is ≥50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥90% or to <200mg per 24h. Progressive disease requires any one or more of the following: increase of ≥25% from lowest response value in the following on 2 consecutive measurements: serum M-component and/or (the absolute increase must be ≥0.5g/dl). Urine M-component and/or (the absolute increase must be ≥200mg/24h. Only in patients without measureable serum and urine M-protein levels: the difference between involved and uninvolved free light chain (FLC) levels. The absolute increase must be >10mg/dl. Bone marrow plasma cell percentage: the absolute % must be ≥10%.|48 months|||percentage of participants||95% Confidence Interval|Number
694304|NCT01402284|Secondary|Progression Free Survival (PFS) at 48 Months|PFS is defined as time of start of treatment to time of progression or death, whichever occurs first. Response is assessed by the International Myeloma Working Group Criteria. Progressive disease requires any one or more of the following: increase of ≥25% from lowest response value in the following on 2 consecutive measurements: serum M-component and/or (the absolute increase must be ≥0.5g/dl). Urine M-component and/or (the absolute increase must be ≥200mg/24h. Only in patients without measureable serum and urine M-protein levels: the difference between involved and uninvolved free light chain (FLC) levels. The absolute increase must be >10mg/dl. Bone marrow plasma cell percentage: the absolute % must be ≥10%. Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in size of existing bone lesions or soft tissue plasmacytomas. Development of hypercalcemia that can be attributed solely to the plasma cell proliferative disorder.|48 months|||percentage of participants||95% Confidence Interval|Number
694305|NCT01402284|Secondary|Overall Response Rate|Response is assessed by the International Myeloma Working Group Criteria. Patients who attained a partial response or better (BoR) response by the end of induction. Partial response is ≥50% reduction of serum M-protein and reduction in 24h urinary M-protein.|48.3 months|||percentage of participants||95% Confidence Interval|Number
694306|NCT01402284|Primary|Number of Participants With Serious and Non-serious Adverse Events|Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|4 years and 9 months and 2 days|||Participants|||Count of Participants
694307|NCT01402141|Primary|Number of Participants With Greater Than 40% Decrease in Histamine-induced Wheal Size (Wheal Size by More Than 40% Decrease in the Number of Subjects Compared With Placebo)|"Number of Participants with Greater than 40% Decrease in Histamine-induced Wheal Size was measured in study visit 1(0 week) and visit 3(12 week).
Percentage change in histamine-induced wheal size calculations were calculated by the formula ((12weeks - 0weeks) * 100/0weeks).
Number of Participants with Greater than 40% Decrease in Histamine-induced Wheal Size compared with placebo."|12weeks|per protocol analysis||participants|||Number
694308|NCT01402141|Secondary|Changes in Eosinophil Cationic Protein(ECP)|Eosinophil Cationic Protein(ECP) was measured in study visit 1(0 week) and visit 3(12 week).|12weeks|per protocol analysis||μg/L||Standard Deviation|Mean
694309|NCT01402141|Secondary|Changes in Eosinophil|Eosinophil was measured in study visit 1(0 week) and visit 3(12 week).|12weeks|per protocol analysis||Percentage of WBCs(white blood cells)||Standard Deviation|Mean
694310|NCT01402141|Secondary|Changes in Interleukin-4|Interleukin-4 was measured in study visit 1(0 week) and visit 3(12 week).|12weeks|per protocol analysis||pg/ml||Standard Deviation|Mean
694311|NCT01402141|Secondary|Changes in Interferon-gamma|Interferon-gamma was measured in study visit 1(0 week) and visit 3(12 week).|12weeks|per protocol analysis||IU/ml||Standard Deviation|Mean
694312|NCT01402141|Secondary|Changes in Serum Histamine|Serum histamine was measured in study visit 1(0 week) and visit 3(12 week).|12weeks|per protocol analysis||μg/g creatinine||Standard Deviation|Mean
694313|NCT01402141|Secondary|Changes in Immunoglobulin E|Immunoglobulin E was measured in study visit 1(0 week) and visit 3(12 week).|12weeks|per protocol analysis||IU/mL||Standard Deviation|Mean
694314|NCT01402141|Primary|Changes in Histamine-induced Wheal Size|Histamine-induced wheal size was measured in study visit 1(0 week) and visit 3(12 week).|12weeks|per protocol analysis||mm^2||Standard Deviation|Mean
694315|NCT01402128|Secondary|Changes in Subcutaneous Adipose Tissue|Subcutaneous adipose tissue was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis||cm^3||Standard Deviation|Mean
694316|NCT01402128|Primary|Changes in Percent Body Fat(%)|Percent body fat(%) was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis||percentage of body fat||Standard Deviation|Mean
694317|NCT01402128|Secondary|Changes in Apo-B(Apolipoprotein B)|Apo-B(Apolipoprotein B) was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis||g/L||Standard Deviation|Mean
694318|NCT01402128|Secondary|Changes in Apo-A1(Apolipoprotein A1)|Apo-A1(Apolipoprotein A1) was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis||g/l||Standard Deviation|Mean
694319|NCT01402128|Secondary|Changes in FFA(Free Fatty Acid)|FFA(free fatty acid) was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis||µEq/L||Standard Deviation|Mean
694320|NCT01402128|Secondary|Changes in Triglyceride|Triglyceride was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis||mg/dL||Standard Deviation|Mean
694321|NCT01402128|Secondary|Changes in Total Cholesterol|Total cholesterol was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis||mg/dL||Standard Deviation|Mean
694322|NCT01402128|Secondary|Changes in HDL-C(High Density Lipoprotein-cholesterol)|HDL-C(High Density Lipoprotein-cholesterol) was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis||mg/dl||Standard Deviation|Mean
694323|NCT01402128|Secondary|Changes in LDL-C (LDL Low Density Lipoprotein-cholesterol)|LDL-C (LDL Low Density Lipoprotein-cholesterol) was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis||mg/dl||Standard Deviation|Mean
694338|NCT01402063|Primary|Progression Free Survival PPX/RT Versus TMZ/RT for Patients With GBM Without Methylation|"MRI response evaluated by RANO criteria
Complete Response (CR): Circumstance when the enhancing tumor is no longer seen by neuroimaging, with the patient off all steroids or on adrenal maintenance only; CR will be coded only if confirmed by a second CT/MR scan performed a minimum of 4 weeks after the initial scan coding a response.
Partial Response (PR): Decrease of > 50% in the product of two diameters. Patients should be receiving stable or decreasing doses of steroids. PR will be coded only if confirmed by a second CT/MR scan performed a minimum of 4 weeks after the initial scan.
Progression (P): A > 25% increase in tumor area (two diameters) provided that the patient has not had his/her dose of steroids decreased since the last evaluation period. This will not need a confirmatory scan. A concomitant decrease in steroid dose will rule out a progression designation during the first 2 months after completion of XRT."|Q 3 months on study then Q3 months in f/u for yr 1, q 4 months yr 2, q 6 months for approximately 4 ys.|||participants|||Number
694339|NCT01401907|Other Pre-specified|Survival||from date of randomization until date of death, assessed up to 3 years||12/2018||||
694340|NCT01401907|Other Pre-specified|Additional Resource Utilization|hospital admissions, hospice utilization emergency room admissions intensive care unit admissions resuscitation attempt|from date of randomization until date of death, assessed up to 3 years||12/2018||||
694341|NCT01401907|Secondary|Coping (Brief Cope)|compare coping between study arms|Week-12 and Week-24||||||
694342|NCT01401907|Secondary|Code Status Documentation|examine rates and timing of code status documenation|study participants will be followed until death or for a minimium of 2 years after enrollment||12/2017||||
694343|NCT01401907|Secondary|Health Care Costs||study participants will be followed until death or for a minimium of 2 years after enrollment||06/2018||||
694344|NCT01401907|Secondary|Resource Utilization at the End of Life (EOL)|chemotherapy utilization at the EOL hospice utilization (enrollment rate and length of stay)|study participants will be followed until death or for a minimium of 2 years after enrollment||12/2017||||
694345|NCT01401907|Secondary|Number and Percentage of Family Caregivers Who Reported the Goal of Treatment is to Cure Cancer|We used the response to an item on Perception of Treatment and Prognosis Questionnaire to compare rates of accurate prognostic understanding between study arms. Family caregivers reported their primary goal of the current cancer treatment: 1) to cure my cancer; 2) to lesson my suffering as much as possible; 3) for me and/or my family to be able to keep hoping; 4) to make sure I have done everything; 5) to extend my life as long as possible; 6) to help cancer research. Family caregivers' responses were dichotomized as 1) to cure my cancer vs. all other.|12 and 24 weeks|Proportion of caregiver goal is cure at week-12 and week-24. Please note the number of participants reflect those who completed the Perception of Treatment and Prognosis Questionnaire at week-12 and week-24, which explains the discrepancy with the participants flow.||Participants|||Count of Participants
694346|NCT01401907|Secondary|Family Caregiver Psychological Distress (Based on the Hospital Anxiety and Depression Scale)|We used the Hospital Anxiety and Depression scale to measure overall psychological distress in family caregivers. The Hospital Anxiety and Depression Scale contains two subscales measuring depression and anxiety respectively. When examined continuously, this scale reflects degree of psychological distress with higher scores indicating more psychological distress (range 0-42). We compared overall psychological distress (HADS-total) among family caregivers between the two study arms|Week 12 and Week 24|Looking at the HADS-total score at week-12 and week-24. Please note the number of participants included in week-12 and week-24 analyses reflect the participants who completed the hospital anxiety and depression scale at these time points (study completers), which explains the discrepancy with the flow chart.||units on a scale||95% Confidence Interval|Mean
694347|NCT01401907|Secondary|Family Caregiver Quality of Life as Measured by the SF-36|The Medical Health Outcomes Survey- Short Form (SF-36) is a measure of QOL. The SF-36 measures eight domains of health-related quality of life: physical functioning, role limitation due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitation due to emotional health, and mental health. The response choices are scored and summed to yield two physical (PCS) and mental (MCS) component summary measures with ranges from 0-100. Higher scores indicate better quality of life. We compared family caregiver PCS and MCS scores between the two study arms at week-12 and week-24 adjusting for baseline scores.|Week-12 and Week-24|Adjusted Means controlling for baseline scores. The different rows reflect Week-12 and Week-24 outcomes on SF-36 PCS and MCS domains. The number of participants included in week-12 and week-24 analyses reflect the participants who completed the SF-36 at these time points, which explains the discrepancy with the flow chart.||units on a scale||95% Confidence Interval|Mean
694348|NCT01401907|Secondary|Number and Percentage of Participants Who Reported Goal of Their Cancer Treatment is to Cure Their Cancer|We used the response to an item on Perception of Treatment and Prognosis Questionnaire to compare rates of accurate prognostic understanding between study arms. Participants reported their primary goal of their current cancer treatment: 1) to cure my cancer; 2) to lesson my suffering as much as possible; 3) for me and/or my family to be able to keep hoping; 4) to make sure I have done everything; 5) to extend my life as long as possible; 6) to help cancer research. Participants' responses were dichotomized as 1) to cure my cancer vs. all other.|Week12 and Week 24|The different rows reflect analyses at week-12 and week-24. Please note the number of participants included in week-12 and week-24 analyses reflect the participants who completed the Perception of Treatment and Prognosis Questionnaire at these time points (study completers), which explains the discrepancy with the flow chart.||Participants|||Count of Participants
694349|NCT01401907|Secondary|Rate of Clinically Significant Depression Symptoms Based on Hospital Anxiety and Depression Scale|The hospital anxiety and depression scale examines symptoms of depression and anxiety. We compared rates of clinically significant depression symptoms (using a cut off of 8 on the depression subscale score) between study arms at week-12 and week-24.|Week-12 and Week-24|The two rows examine outcomes at two different time points week-12 and week-24. Please note the number of participants included in week-12 and week-24 analyses reflect the participants who completed the hospital anxiety and depression scale at these time points (study completers), which explains the discrepancy with the flow chart.||Participants|||Count of Participants
694457|NCT01401101|Primary|PTSD Symptoms|same as baseline and 6 months|12 months|Clinician-Administered PTSD Scale (CAPS) severity score: sum of ratings (from 0-4) for frequency and intensity across each of the 17 symptom items for a possible range of 0-136, where a higher score indicated higher severity.||CAPS scores||95% Confidence Interval|Mean
694350|NCT01401907|Secondary|Functional Assessment of Cancer Therapy (Quality of Life Measure)|The Functional Assessment of Cancer Therapy - General is a quality of life measure with higher scores indicating better quality of life (range 0-108). We are examining the adjusted mean difference from baseline to 24 weeks.|24 weeks|The analysis focuses on participants who completed week-24 questionnaires (N = 118 in the early palliative care arm, and N = 124 in the standard of care arm)||units on a scale||95% Confidence Interval|Mean
694351|NCT01401907|Primary|Functional Assessment of Cancer Therapy (Quality of Life Measure)|The Functional Assessment of Cancer Therapy - General is a quality of life measure with higher scores indicating better quality of life (range 0-108). We are examining the adjusted mean difference from baseline to 12 weeks in this study|12 weeks|||units on a scale||95% Confidence Interval|Mean
694352|NCT01401842|Secondary|Dynamic Lumbar Extension Muscular Endurance at 11 Weeks|Dynamic lumbar extension muscular endurance (# repetitions at 50% peak torque) as assessed by a validated physical performance test on the lumbar dynamometer|11 weeks|Adjusted (by baseline score) isometric core muscular endurance in seconds (mean ± SE) at follow-up. Differences in sample sizes for this outcome (compared with primary outcome) are due to invalid test data for this outcome (n = 11 stabilization arm; n = 18 strengthening arm).||repetitions||Standard Error|Mean
694353|NCT01401842|Secondary|Isometric Core Muscular Endurance at 11 Weeks|Isometric core muscular endurance as assessed by a validated physical performance test (prone static plank test)|11 weeks|Adjusted (by baseline score) isometric core muscular endurance in seconds (mean ± SE) at follow-up. Differences in sample sizes for this outcome (compared with primary outcome) are due to invalid test data for primary outcome (n = 4 stabilization arm; n = 1 strengthening arm), and incomplete data for this outcome (n = 1 stabilization arm).||seconds||Standard Error|Mean
694354|NCT01401842|Primary|Isometric Lumbar Extension Muscular Strength at 11 Weeks|Isometric lumbar extension muscular strength (torque - Nm) as assessed by a validated physical performance test on the lumbar dynamometer|11 weeks|Adjusted (by baseline score) isometric lumbar extension muscular strength in Nm (mean ± SE) at follow-up||Nm||Standard Error|Mean
694355|NCT01401647|Secondary|Number of Participants Scoring at or Below a 3 on the MRS Scale|Neurologic status at discharge will be assessed using the modified Rankin Score (MRS). A higher value indicates a worse outcome. 0-No symptoms at all; 1-No significant disability despite symptoms; able to carry out all usual duties and activities, 2-Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance, 3-Moderate disability; requiring some help, but able to walk without assistance; 4-Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance, 5-Severe disability; bedridden, incontinent and requiring constant nursing care and attention; 6-Dead|Patients will be followed from the time of the cardiac arrest until death, hospital discharge, or December 31, 2015, whichever occurs first.|MRS as a secondary outcome is not available on all patients that we have survival for.||Participants|||Count of Participants
694356|NCT01401647|Primary|Number of Participants Who Survive From the Time of Cardiac Arrest to Hospital Discharge|Patients may die in the field (outside of the hospital at the time of the cardiac arrest), at the emergency room, in the hospital, or they are discharged alive from the hospital.|Patients will be followed from the time of the cardiac arrest until death, hospital discharge, or December 31, 2015, whichever occurs first.|The primary objective is to determine if survival to hospital discharge is improved with early therapeutic administration of IV amiodarone (PM101) compared to placebo.The secondary objectives of the trial are to determine if survival to hospital discharge is improved with early therapeutic administration of Lidocaine vs placebo; PM101 vs lidocaine.||participants|||Number
694357|NCT01401595|Secondary|Night Eating Symptoms|"The responses on the Night Eating Symptom Scale (NESS) will be examined over time.
Subjects will complete the NESS at their baseline visit, and at every treatment visit thereafter. The Night Eating Symptom Scale-II (NESS-II) (Lundgren, Allison, Vinai, & Gluck, 2012) is a 14-item questionnaire (possible range of 0–56, with higher scores indicating more severe symptoms) that assesses the presence of NES features over the course of the previous week. The NESS will indicate whether or not escitalopram is having an effect on our participants' night eating symptoms."|12 weeks|||units on a scale||Standard Error|Mean
694358|NCT01401595|Secondary|Night Eating Symptoms|Number of nocturnal ingestions (waking and having something to eat) were reported at each visit.|12 weeks|||units on a scale||Standard Error|Mean
694359|NCT01401595|Primary|Change in Symptoms of NES|Outcome of treatment will be measured by self report questionnaire, the Night Eating Symptom Scale ( higher score indicates worse symptoms). The percentage of calories consumed after dinner was estimated by recall at each treatment visit, as compared to their baseline % of intake after dinner, which was calculated through food diaries. The number of nocturnal ingestions (waking during the night and eating) per week was also recalled at each treatment visit.|12 weeks|||percentage of calories after dinner||Standard Error|Mean
694360|NCT01401582|Secondary|Person With Dementia: Change in Medication|The DCM will conduct an IT-supported home medication review (Fiss et al., 2010) at the patients home with subsequent medication management by the local pharmacy regarding frequency of drug related problems, intake of PIM, clinically relevant drug-drug interaction, adherence, utilisation of adherence supporting activities (medication plan, drug dispenser, support by care service, reduction of the number of drugs taken|participants will be followed yearly until institutionalisation or death after an expected average of 5 years||05/2017||||
694361|NCT01401582|Secondary|Person With Dementia: Change in Utilization of Health Care Resources|"frequency of utilisation of
general physicians and physicians of other specialties
out-patient treatments
in-patient treatments
hospitalisations
institutionalisation
therapeutic appliances
standardised assessment with the Resource Utilization in Dementia (RUD, Wimo et al. 1998)."|participants will be followed yearly until institutionalisation or death after an expected average of 5 years||05/2017||||
694362|NCT01401582|Secondary|Person With Dementia and Caregiver: Change in Health Status|"Several instruments will be used to assess the health of the person with dementia:
the GP records the Fragebogen zum SF12- health survey (SF-12, Bullinger et al. 1998) the standardized assessment of elderly in primary care (STEP; Sandholzer et al. 2004) the Brief Symptom Inventory (BSI; Derogatis et al. 1983) the Patient´s health questionnaire (PHQ-D; Löwe et al. 2002, Spitzer et al. 1999)"|participants will be followed yearly until institutionalisation or death after an expected average of 5 years||05/2017||||
703391|NCT00094900|Secondary|Mean Change in Ferritin|Ferritin level change from baseline to 24 months|24 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||mcg/L||Standard Error|Mean
694365|NCT01401582|Secondary|Person With Dementia: Change in Activities of Daily Living|"The functional status was assessed using the Bayer Activities of Daily Living Scale (B-ADL). It coonsits of 25 Items indicating everyday problems/ challenges. Their occurence is rated on a scale of 1 never, to 10 always. All ratings are added and divided by the number of items. This yields a mean score of 1 to 10, where 1 indicates the lowest possible impairment and 10 indicates the highest possible impairment."|one year after baseline assessment|||units on a scale||Standard Deviation|Mean
694366|NCT01401582|Primary|Reduction of Potential Inapropriate Medication (PIM)|Having to deal with multimorbidity and polypharmacy in a sample of chronically ill elderly, we also analyze potentially inappropriate medication (PIM), defined as “a drug for which the risk of an adverse event outweighs the clinical benefit, particularly when there is evidence in favor of a safer or more effective alternative therapy for the same condition”. The PIM were identified using the Priscus list, which contains 83 drugs from 18 different drug classes.|one year after baseline assessment|||Participants|||Count of Participants
694367|NCT01401582|Primary|Change in Medical Treatment With Antidementia Drugs|medication was systematically reviewed; A computer-based home medication review (HMR) encompasses all medications used by the study participants and includes questions about compliance, adverse effects and drug administration. The collection of primary data on medication in the context of the HMR includes both prescription drugs and over-the-counter drugs. The assignment was then integrated using a master file of the Pharmaceutical Index. The following antidementia drugs were considered: donepezil (N06AD02), rivastigmine (N06AD03), galantamine (N06AD04) and memantine (N06AX01).|one year after baseline assessment|||participants|||Number
694368|NCT01401582|Primary|Change in Behavioral and Psychological Symptoms of Dementia|Neuropsychiatric Inventory (NPI; Cummings 1997); The NPI represents an interview by proxy on twelve dimensions of neuropsychiatric behaviors, i.e. delusions, hallucinations, agitation, dysphoria, anxiety, apathy, irritability, euphoria, disinhibition, aberrant motor behavior, night-time behavior disturbances, and appetite and eating abnormalities. The presence (0= no, 1= yes) is asked. If present, the severity (rated 1 through 3; mild to severe) and frequency (1 to 4, rarely to very often) of each neuropsychiatric symptom are rated on. Thus the score for each dimension ranges from 0 = not present, 1= mildly and rarely to 12 = severe and often. A total NPI score is calculated as the sum of the frequency by severity scores ofeach domain range: 0 to 144, the higher the more neuropsychiatric symptomatic).|one year after baseline assessment|||units on a scale||Standard Deviation|Mean
694369|NCT01401582|Primary|Change in Caregiver Burden|Caregiver burden was assessed using the „Berliner Inventar zur Angehörigenbelastung – Demenz“ (BIZA-D) (Zank et al., 2006). The BIZAD was developed to assess objective as well as subjective burden due to caring for a person wit dementia (PWD). It consists of 88 items covering 20 dimensions of caregiver burden. Objective burden is divided into six dimensions: 1) basic care tasks like support eating, hygiene etc (7 items), 2) extended care tasks like supporting grocery shopping, legal affairs etc. (3 items), 3) Motivation and Guidance (4 items), 4) emotional support (4 items), 5) supporting maintenance of social contacts (3 items) and 6) supervision (4 items). Each item has to be rated regarding the frequency of the support needed on a 5-Point scale (example: supervision; Does the patient need this kind of support: 1=always, 2= mostly, 3=partly, 4=hardly, 5= not at all). Then each item asks: Who is providing this support: all by someone else, mostly by someone else, evenly distributed|one year after baseline assessment|||units on a scale||Standard Deviation|Mean
694370|NCT01401582|Primary|Change in Quality of Life|The Quality of Life in Alzheimer's Disease (Qol-AD; Logsdon et al. 2002) was used. This measure designed specifically to obtain a rating of the patient's quality of life from both the patient and the caregiver. Each item is rated on a four point scale, with 1 being poor and 4 being excellent. Total scores, obtained by the sum of all 13 items, range from 13 to 52.|one year after baseline assessment|||units on a scale||Standard Deviation|Mean
694371|NCT01401517|Secondary|Assessment of Improvement of Quality of Life.|Demonstrate the pharmacodynamic effect of sodium nitrite on changes in measures of claudication symptoms at 10 weeks following the first administration of a dose. Quality of Life questionnaires (WIQ & RAND 36)will be completed prior to the first dose of the investigational product and again after 10 weeks of administration but before dose escalation.|10 weeks||||||
694372|NCT01401517|Secondary|Assessment of Changes in Walking Distance.|Demonstrate the pharmacodynamic effect of sodium nitrite on changes in functional measures of walking distance. The distance a subject can walk in 6 minutes will be measured prior to the first administration of the investigational product and 10 weeks after taking the investigational product but before the dose escalation.|10 weeks||||||
694373|NCT01401517|Secondary|Assessment of Changes in Brachial Artery Flow-Mediated Dilation (FMD)at 10 Weeks From Baseline|Demonstrate the pharmacodynamic effect of sodium nitrite on changes in FMD by imaging before investigational product administration and 10 weeks after administration of investigational product but before dose escalation.|10 weeks||||||
694374|NCT01401517|Primary|Reporting of Adverse Events During 11 Week Treatment Period.|The primary objective of this clinical study is to evaluate the safety and tolerability of multiple doses of twice daily 40mg and 80mg sodium nitrite compared with placebo over a 10 week treatment period. Subjects will be asked to report any adverse events during the trial period, and blood pressure, methemoglobin levels and other blood chemistries will be assessed during the trial period for changes from baseline.|11 weeks|||participants|||Number
694375|NCT01401478|Secondary|Percentage of Participants Who Developed Hypercalcemia and Hyperphosphatemia Leading to Study Termination|"The percentage of participants who developed hypercalcemia (too much calcium in the blood) and hyperphosphatemia (too much phosphate in the blood) leading to study termination was recorded.
Hypercalcemia was defined as calcium level greater than 11.2 mg/dL for more than 8 weeks, and hyperphosphatemia was defined as phosphate level greater than 6.5 mg/dL for more than 8 weeks."|6 months|||Percentage of participants||95% Confidence Interval|Number
694376|NCT01401478|Secondary|Percentage of Participants Who Developed Elevated Normalized Total Calcium (> 11.2 mg/dL) at Each Visit Post-baseline During the Study|The percentage of participants who developed elevated normalized total calcium (> 11.2 mg/dL) at each visit post-baseline during the study was recorded.|6 months|||Percentage of participants||95% Confidence Interval|Number
694377|NCT01401478|Secondary|Percentage of Participants Who Developed Elevated Normalized Total Calcium (> 11.2 mg/dL) at Least Once Post-baseline During the Study|The percentage of participants who developed elevated normalized total calcium (> 11.2 mg/dL) at least once post-baseline during the study was recorded.|6 months|||Percentage of participants||95% Confidence Interval|Number
694378|NCT01401478|Secondary|Percentage of Participants Who Developed Elevated Calcium (Ca) x Phosphate (P) (> 75 mg˄2/dL˄2) Levels at Each Visit Post-baseline During the Study|The percentage of participants who developed elevated calcium (Ca) x phosphate (P) (> 75 mg˄2/dL˄2) levels at each visit post-baseline during the study was recorded.|6 months|||Percentage of participants||95% Confidence Interval|Number
694379|NCT01401478|Secondary|Percentage of Participants Who Developed Elevated Calcium (Ca) x Phosphate (P) (> 75 mg˄2/dL˄2) Levels at Least Once Post-baseline During the Study|The percentage of participants who developed elevated calcium (Ca) x phosphate (P) (> 75 mg˄2/dL˄2) levels at least once post-baseline during the study was recorded.|6 months|||Percentage of participants||95% Confidence Interval|Number
694380|NCT01401478|Secondary|Percentage of Participants Who Reached the Kidney Disease Improving Global Outcomes Target Level of Intact Parathyroid Hormone (iPTH) at Each Visit During the Study|The percentage of participants who reached the Kidney Disease Improving Global Outcomes target level of intact parathyroid hormone (iPTH) (defined as the achievement of iPTH level 2 to 9 times the upper limit of normal) at each visit during the study was recorded.|6 months|The analysis for this outcome was based on the number of participants (55) who completed the study.||Percentage of participants||95% Confidence Interval|Number
694381|NCT01401478|Secondary|Percentage of Participants Who Reached the Kidney Disease Improving Global Outcomes Target Level of Intact Parathyroid Hormone (iPTH) at Least Once During the Study|The percentage of participants who reached the Kidney Disease Improving Global Outcomes target level of intact parathyroid hormone (iPTH) (defined as achievement of iPTH level 2 to 9 times the upper limit of normal) at least once during the study was recorded.|6 months|||Percentage of participants||95% Confidence Interval|Number
694382|NCT01401478|Primary|The Percentage of Participants Who Reached a Target Level of Intact Parathyroid Hormone (iPTH) (150-300 pg/mL) Post-baseline at Least Once During the Study|The percentage of participants who had a post-baseline intact parathyroid hormone (iPTH) level in the range of 150 to 300 pg/mL at least once during the study was recorded.|6 months|||Percentage of participants||95% Confidence Interval|Number
694383|NCT01401465|Secondary|The Percentage of Subjects Experiencing AEs||Over both two-week treatment periods combined|ITT||percentage of participants|||Number
694384|NCT01401465|Secondary|The Number of Subjects Experiencing AEs||Over both two-week treatment periods combined|ITT||participants|||Number
694385|NCT01401465|Secondary|The Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation||Over both two-week treatment periods combined|ITT||percentage of participants|||Number
694386|NCT01401465|Secondary|The Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation||Over both two-week treatment periods combined|ITT||participants|||Number
694387|NCT01401465|Secondary|Work/Disability Days: Reduced Activity Days|Assessed at the end of each two-week treatment period|Period 1 (days 0-14), Period 2 (days 29-43)|IIT||Incidence Rate (#events/person-days)|||Number
694388|NCT01401465|Secondary|Work/Disability Days: Missed Work|Assessed at the end of each two-week treatment period|Period 1 (days 0-14), Period 2 (days 29-43)|ITT Population||Incidence Rate (#events/person-days)|||Number
694389|NCT01401465|Secondary|Work/Disability Days: Bed Days|Assessed at the end of each two-week treatment period|Period 1 (days 0-14), Period 2 (days 29-43)|ITT Population||Incidence Rate (#events/person-days)|||Number
694390|NCT01401465|Secondary|Treatment Outcome Composite Score Assessed at the End of the Study|Reflects preference on items concerned with perceived drug effectiveness (longer relief; symptom relief; prefer if both were the same price; for feeling better about your appearance; for few problems with irritation to nose; faster relief; how it makes your nose feel). The score is based on the proportion of items (x 100) preferred for ciclesonide and a score of 50 indicates an equal number of items preferred in the two groups. Larger values than 50 indicated greater than 50 percent of the subjects indicated preference for ciclesonide, while smaller values than 50 indicated greater than 50 percent preference for mometasone. Data is presented as the mean treatment outcome composite score. This analysis presents the comparison of ciclesonide versus mometasone in relation to preference for ciclesonide.|End of Study - Day 43|ITT Population||Scores on a scale||Standard Deviation|Mean
694391|NCT01401465|Secondary|The Change From Baseline in Health-Related Quality of Life: Work Well Being Questionnaire Scale|The mean of 1 question on how many days worked and 12 questions on level of satisfaction with work, ability to do work, problems completing work (physical and emotional); 1 questions on rating of leisure activities. Scores range from 1 (lower satisfaction) to 10 (higher satisfaction).|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population||units on a scale||Standard Error|Least Squares Mean
694392|NCT01401465|Secondary|The Change From Baseline in Health-Related Quality of Life: General Health Perceptions Scale|The mean of 11 questions on sleep disturbance, vitality and general health status. Scores range from 100 (lower satisfaction) to 500 (higher satisfaction).|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population||units on a scale||Standard Error|Least Squares Mean
694393|NCT01401465|Secondary|The Change From Baseline in Health-Related Quality of Life: Mental and Emotional Health Scale|The mean of 24 questions encompassing anxiety, depression, and loss of behavioral and emotional control (Psychological Distress), life satisfaction, positive well being and emotional ties (Psychological Well Being).Scores range from 100 (lower satisfaction) to 500 (higher satisfaction)|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population||units on a scale||Standard Error|Least Squares Mean
694394|NCT01401465|Secondary|The Change From Baseline in Health-Related Quality of Life: Symptoms and Side-Effects Distress Scale|The mean of 48 questions including allergic-rhinitis and allergic-rhinitis treatment specific and general symptoms measured for prevalence, frequency and distress severity. Scores range from 100 (lower satisfaction) to 600 (higher satisfaction).|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population||units on a scale||Standard Error|Least Squares Mean
703392|NCT00094900|Secondary|Mean Change in Ferritin|Ferritin level change from baseline to 12 months|12 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||mcg/L||Standard Error|Mean
694395|NCT01401465|Secondary|The Change From Baseline in Health-Related Quality of Life: General Symptom Interference Scale|The mean of 7 questions concerning life interference due to nonallergic rhinitis specific symptoms (“other symptoms or health problems such as fatigue, pain and depression” with the same life activities: 1) work, 2) social events, 3) recreational activities, 4) exercise and physical activities, 5) work effectiveness, 6) enjoying life and 7) “feeling your best”. Scores range from 1 (lower satisfaction) to 10 (higher satisfaction)|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population||units on a scale||Standard Error|Least Squares Mean
694396|NCT01401465|Secondary|The Change From Baseline in Health-Related Quality of Life: Allergic-Rhinitis Specific Symptom Interference Scale|The mean of 7 questions concerning interference with life activities due to the symptoms of allergic-rhinitis (nasal congestion, runny nose, itchy throat or sneezing) interfered with your ability to perform life activities. The life activities included: 1) work, 2) social events, 3) recreational activities, 4) exercise and physical activities, 5) work effectiveness, 6) enjoying life and 7) “feeling your best”. Scores range from 1 (lower satisfaction) to 6 (higher satisfaction)|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population||units on a scale||Standard Error|Least Squares Mean
694397|NCT01401465|Secondary|The Change From Baseline in Health-Related Quality of Life: Perceived Health (Global Analogue Scale)|The mean of 5 questions: Feeling past month 1) overall or in general, 2) physically, 3) emotionally, 4) personal life and 5) about job or work. Scores range from 100 (lower satisfaction) to 500 (higher satisfaction)|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population||units on a scale||Standard Error|Least Squares Mean
694398|NCT01401465|Secondary|The Change From Baseline in Overall Quality of Life Composite Score|Mean of all items in the Mental and Emotional Health and General Health Perceptions scales. Scores range from 100 (lower satisfaction) to 500 (higher satisfaction)|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT||scores on a scale||Standard Error|Least Squares Mean
694399|NCT01401465|Secondary|The Change From Baseline in the Treatment Satisfaction Rating Scale: Perceived Relief|The patient’s perceived level of relief along with the degree of satisfaction associated with that amount of relief was evaluated within this scale. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction).|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population||units on a scale||Standard Error|Least Squares Mean
694400|NCT01401465|Secondary|Change From Baseline in the Treatment Satisfaction Rating Scale: Regimen Management|This subscale evaluates the patient’s assessment of issues relating to dosing (number of times and the time required to dose), ability to remember to use the spray, the ease/difficulty of the spray and several questions further pertaining to the convenience of the treatment. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction).|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population||units on a scale||Standard Error|Least Squares Mean
694401|NCT01401465|Secondary|Change From Baseline in the Treatment Satisfaction Rating Scale: Burden|This subscale evaluates the patient’s assessment of the level of degree of burden that treatment for allergic rhinitis imposes on a number of areas, including adherence to the treatment regimen, exercise, performing daily activities, social activities, and enjoying life. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction).|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population||units on a scale||Standard Error|Least Squares Mean
694402|NCT01401465|Secondary|Change From Baseline in the Treatment Satisfaction Rating Scale: Hassle|This subscale focuses specifically on the patient’s assessment of the amount of bother and hassle of the treatment regimen, including coordinating activities, dosing, carrying supplies, rubbing nose or eyes, blowing nose repeatedly, or facial puffiness. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction). Scores range from 0 (lower satisfaction) to 100 (higher satisfaction).|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population||units on a scale||Standard Error|Least Squares Mean
694403|NCT01401465|Secondary|Change From Baseline in the Treatment Satisfaction Rating Scale: Sensory Impact|This subscale evaluates the patient’s assessment of the sensory attributes including medication running out of the nose, medication running down the throat, and impact on smell and taste. Issues regarding skipping the medication because of the way the nose feels and wanting to try other medications to find a better one are also included. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction).|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population||units on a scale||Standard Error|Least Squares Mean
694404|NCT01401465|Secondary|Change From Baseline in the Treatment Satisfaction Rating Scale: Regimen Difficulties|This subscale evaluates the patient’s degree of pain, discomfort and side effects perceived to be associated with treatment, and the extent to which pain and discomfort were bothersome. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction).|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population||units on a scale||Standard Error|Least Squares Mean
694405|NCT01401465|Secondary|Change From Baseline in the Treatment Satisfaction Rating Scale: Role Limitation|This subscale evaluates the patient’s assessment of the degree of interference with social interactions with family, friends, travel, having fun, problems in performing work or social roles and how flexible the treatment was with scheduling life activities. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction).|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population||units on a scale||Standard Error|Least Squares Mean
694406|NCT01401465|Secondary|Change From Baseline in the Treatment Satisfaction Rating Scale: Regimen Adaptation|This subscale evaluates the patient’s assessment of the convenience of the treatment, whether the treatment was one the subject would recommend to other persons with the same condition, and the level of satisfaction with the current treatment. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction).|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population||units on a scale||Standard Error|Least Squares Mean
694407|NCT01401465|Secondary|Change From Baseline in the Treatment Satisfaction Rating Scale: Interference|This subscale evaluates the patient’s assessment of the degree to which allergy symptoms or side effects of the nasal spray interfered with daily routine, meals, recreation, family life, sleep schedules, energy levels, making plans, traveling, having fun and overall quality of life. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction).|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population||units on a scale||Standard Error|Least Squares Mean
694408|NCT01401465|Secondary|Change From Baseline in the Regimen Acceptance Composite Score|A combination of the Perceived Relief Scale and the Regimen Adaptation Scale. The composite score and all subscales range from 0 (lower satisfaction) to 100 (higher satisfaction). This is an unweighted average of the combined scales.|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population||scores on a scale||Standard Error|Least Squares Mean
694409|NCT01401465|Secondary|Change From Baseline in the Treatment Functional Impact Composite Score|A combination of the Interference Scale, the Role Limitation Scale, and the Burden Scale. The composite score and the subscales all range from 0 (lower satisfaction) to 100 (higher satisfaction). This is an unweighted average of the combined scales.|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population||scores on scale||Standard Error|Least Squares Mean
694410|NCT01401465|Secondary|Change From Baseline in Subject-reported AM and PM rTNSS Averaged Over Each 2-week Treatment Period.|The reflective Total Nasal Symptom Score (rTNSS) is the sum of 4 Nasal Symptoms: Runny Nose, Sneezing, Itchy Nose, and Nasal Congestion. These symptoms were assessed each morning and evening, and their totals averaged to obtain a daily average rTNSS. These daily averages were averaged over the 6 days prior to treatment to obtain the baseline value, and over the 14 days of each two-week period to obtain the on-treatment averages. The baseline values were then subtracted from the on-treatment averages to obtain the change from baseline scores. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent, 1 = mild ,2 = moderate ,3 = severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval.|Averages over each two week treatment period|Per Protocol (PP) Population||units on a scale||Standard Error|Least Squares Mean
694411|NCT01401465|Secondary|Treatment Process Composite Preference Score|The Treatment Process Composite Preference Score is a standardized sum of 9 individual preference items (Ease of use, Convenience, Flexibility Daily Activity, Taste, Use in public, Smell. Less “Run out” of nose, Less “Run down” of throat, Number Sprays Dose). For each of these 9 individual items, patients were forced to choose their preference between ciclesonide nasal aerosol 74 mcg and mometasone AQ 200 mcg. Larger values greater than 50 indicated greater preference for ciclesonide, while smaller values less than 50 indicated greater preference for mometasone.|End of Study - Day 43|ITT||scores on a scale||Standard Deviation|Mean
694412|NCT01401465|Primary|Change From Baseline in Regimen Attributes Composite Score|The Regimen Attributes Composite Score is a composite of the Sensory Impact and Regimen Management Scales of the Allergic Rhinitis Treatment Satisfaction and Preference Scales. The Regimen Management Scale assess patient satisfaction with issues relating to dosing, ability to remember to use the spray, the ease/difficulty of the spray, and convenience of the treatment. The Sensory Impact Scale assess patient satisfaction with issues relating to sensory attributes, including medication running out of the nose, medication running down the throat, impact on smell/taste, etc. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction).|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population||scores on a scale||Standard Error|Least Squares Mean
694413|NCT01401465|Primary|Total Preference Composite Score Assessed at the End of the Study. The Total Preference Score is the Standardized Sum of 17 Individual Preference Items|"For the 17 individual items, patients were forced to choose their preference between ciclesonide and mometasone (item choices: 1 = prefer ciclesonide; 0 = prefer mometasone). The items for the Total Preference Score assessed 16 treatment attributes and one overall treatment preference: Ease of use, Convenience, Flexibility in daily activities, Taste, Use in public, Smell, Less run out of nose, Longer relief, Less run down of throat, Symptom relief, If both were the same price, Better appearance, Less nasal irritation, Faster relief, Number of sprays per dose, Makes nose feel, and Overall - the one preferred. The score is based on the proportion of items (x 100) preferred for ciclesonide and a score of 50 indicates no preference and scores over 50 indicate preference for ciclesonide. This analysis presents the comparison of ciclesonide versus mometasone and provides the score in relation to the preference for ciclesonide."|End of Study - Day 43|Intent to Treat (ITT)- All randomized subjects who received at least one dose of study medication||scores on a scale||Standard Deviation|Mean
694421|NCT01401452|Secondary|Mean Dermatology Life Quality Index (DLQI) Scores|The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment- related feelings. Participants respond to 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means that psoriasis has an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all.|Baseline, Months 1, 3, 6, and 9|Participants with available data||units on a scale||Standard Deviation|Mean
694498|NCT01400841|Secondary|Cardiac Index - Change From Baseline|Hemodynamic parameter computed as cardiac output divided by body surface area|Baseline, 6 months postprocedure|Both baseline and 6-month measure available for 7 of 15 participants.||l/min/m^2||Standard Deviation|Mean
694414|NCT01401452|Secondary|Percentage of Participants Achieving Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Short Form 36 (SF-36) Mental Component Summary (MCS) Scores at 1, 3, 6, and 9 Months|"The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 worst-100 best). Increases from baseline indicate improvement. Assessments were conducted at baseline, 1 month, 6 months, and 9 months. The percentage of participants achieving MCID in the SF-36 MCS was defined as an increase in MCS of at least 5 points from the baseline score."|Baseline, Months 1, 3, 6, and 9|Participants with available data||percentage of participants|||Number
694415|NCT01401452|Secondary|Percentage of Participants Achieving Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Short Form 36 (SF-36) Physical Component Summary (PCS) Scores at 1, 3, 6, and 9 Months|"The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 worst-100 best). Increases from baseline indicate improvement. Assessments were conducted at baseline, 1 month, 6 months, and 9 months. The percentage of participants achieving MCID in the SF-36 PCS was defined as an increase in PCS of at least 3 points from the baseline score."|Baseline, Months 1, 3, 6, and 9|Participants with available data||percentage of participants|||Number
694416|NCT01401452|Secondary|Mean Health Assessment Questionnaire Short Form 36 (SF-36) Mental Component Summary (MCS) Scores at 1, 3, 6, and 9 Months|"The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 worst-100 best). Increases from baseline indicate improvement. Assessments were conducted at baseline, 1 month, 6 months, and 9 months."|Baseline, Months 1, 3, 6, and 9|Participants with available data. Missing values were imputed if single answers were missing for one dimension.||units on a scale||Standard Deviation|Mean
694417|NCT01401452|Secondary|Mean Health Assessment Questionnaire Short Form 36 (SF-36) Physical Component Summary (PCS) Scores at 1, 3, 6, and 9 Months|"The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 worst-100 best). Increases from baseline indicate improvement. Assessments were conducted at baseline, 1 month, 6 months, and 9 months."|Baseline, Months 1, 3, 6, and 9|Participants with available data. Missing values were imputed if single answers were missing for one dimension.||units on a scale||Standard Deviation|Mean
694418|NCT01401452|Secondary|Percentage of Participants Achieving a Psoriasis Area and Severity Index 100 (PASI 100) Response at Months 1, 3, 6, and 9|The percentage of participants with a ≥ 100% reduction (improvement) in the Psoriasis Area and Severity Index (PASI) score from baseline was calculated. PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.|Baseline, Months 1, 3, 6, and 9|Participants with available data||percentage of participants|||Number
694419|NCT01401452|Secondary|Percentage of Participants Achieving a Psoriasis Area and Severity Index 90 (PASI 90) Response at Months 1, 3, 6, and 9|The percentage of participants with a ≥ 90% reduction (improvement) in the Psoriasis Area and Severity Index (PASI) score from baseline was calculated. PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.|Baseline, Months 1, 3, 6, and 9|Participants with available data||percentage of participants|||Number
694420|NCT01401452|Secondary|Percentage of Participants Achieving a Psoriasis Area and Severity Index 50 (PASI 50) Response at Months 1, 3, 6, and 9|The percentage of participants with a ≥ 50% reduction (improvement) in the Psoriasis Area and Severity Index (PASI) score from baseline was calculated. PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.|Baseline, Months 1, 3, 6, and 9|Participants with available data||percentage of participants|||Number
694422|NCT01401452|Primary|Percentage of Participants Achieving a Psoriasis Area and Severity Index 75 (PASI 75) Response at Months 1, 3, 6, and 9|The percentage of participants with a ≥ 75% reduction (improvement) in the Psoriasis Area and Severity Index (PASI) score from baseline was calculated. PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.|Baseline, Months 1, 3, 6, and 9|Participants with available data||percentage of participants|||Number
694423|NCT01401361|Secondary|Secondary Efficacy|"Secondary efficacy / Chronic success is defined as freedom from recurrence of typical atrial flutter 3 months post ablation. Flutter recurrence will be documented on an ECG (or similar such as Holter, telemetry, rhythm strips, etc.). Repeat ablations, new antiarrhythmia medication (Class Ia, Ic, or III) or increase in the dosage of existing anti-arrhythmic medication (Class 1a,
1c, III) during the 3 months post ablation are considered chronic failures."|3 months|134 subjects were treated with the investigational catheter and system with 10 subjects experiencing recurring AFL. Thus 124 subjects comprised the secondary efficacy cohort (freedom from AFL at 90 days).||participants|||Number
694424|NCT01401361|Primary|Primary Efficacy|Primary efficacy or Acute success is defined as achievement of bidirectional block in the cavo-tricuspid isthmus and non-inducibility of typical atrial flutter at least 30 minutes following the last RF ablation with the investigational system.|30 minutes|134 subjects were treated with the investigational catheter and system with 1 subject failing to pass the bidirectional block inducibility test 30 minutes post ablation. Thus 133 subjects comprised the primary efficacy cohort.||participants|||Number
694425|NCT01401361|Primary|Primary Safety:Incidence of Composite, Serious Adverse Events Within 7 Days Post Procedure|Primary safety is defined as the incidence of composite, serious adverse events within 7 days post-procedure, regardless of whether a determination can be made regarding device relatedness.|7 days|150 subjects who met Inc/Excl criteria were enrolled. 16 subjects were withdrawn prior to the use of the investigational device, thus,134 were treated. 3 subjects had composite adverse events that were serious and occurred within 7 days of the ablation procedure. These events are part of the primary safety endpoint analysis per protocol.||participants|||Number
694426|NCT01401322|Primary|Time-to-Progression (TTP)||12 weeks|||Days||Full Range|Median
694427|NCT01401283|Secondary|Hospital Stay|length of stay in the postoperative care unit, length of hospital stay|Participants will be followed for the duration of hospital stay, an expected average of 10 days|||days||Inter-Quartile Range|Median
694428|NCT01401283|Primary|Postoperative Complications|Categories of postoperative complications: Infection (respiratory, abdominal, UTI, wound), Respiratory (prolonged need for ventilation), Cardiovascular (edema, arrythmia, hypotension, AMI, stroke), Abdominal (constipation), Renal (urine output <500ml/d, ARF)|Participants will be followed from end of surgery for the duration of stay in the recovery room, for the duration of the complete hospital stay, an expected average of ten 10 days|||numbers of complications|||Number
694429|NCT01401257|Secondary|To Assess the Plasma Concentrations of PXT3003|PXT3003 plasmatic concentrations after one administration (randomization) and after 1-,6-and 12-months of treatment.|Randomization, 1-, 6- and 12-month treatment||||||
694430|NCT01401257|Secondary|To Assess the Pharmacodynamic Effect of PXT3003 on a Series of Biochemical Biomarkers|"Dosages of biochemical biomarkers in plasma.
Change from baseline after 3-month of treatment."|Randomization and 3-month treatment||||||
694431|NCT01401257|Secondary|To Assess the Pharmacodynamic Effect of PXT3003 on Selected Neurophysiological Parameters|"Electrophysiological examination will be performed to assess sensory and motor responses of the median and ulnar nerves (non-dominant side) including: NCV, compound muscle action potential (CMAP) and SNAP.
Change from baseline after 3-,6-, 9- and 12-months of treatment."|Screening, randomization, 3-, 6-, 9- and 12-month treatment||||||
694432|NCT01401257|Secondary|To Assess the Pharmacodynamic Effect of PXT3003 on PMP22 mRNA Levels and Intra-epidermal Axon Density in Cutaneous Biopsy|"A cutaneous biopsy (consisting in 2 small punch biopsies) will be performed to assess PMP22 mRNA expression and intra-epidermal axon density.
Change from baseline after 12-month of treatment."|Randomization and 12-month treatment||||||
694433|NCT01401257|Secondary|To Obtain Preliminary Data on the Efficacy of PXT3003 on Clinical Scores and Functional Tests|"Efficacy scores and functional tests will be assessed CMTNS/CMTES:ONLS, VAS, fatigue, pain, six minute walk test (6MWT), nine-hole peg test, quantified muscular testing (QMT; hand grip and foot dorsiflexion), CGI.
For each test or score, change from baseline after 3-,6-, 9- and 12-months of treatment."|Screening, randomization, 3-, 6-, 9- and 12-months treatment||||||
694434|NCT01401257|Primary|Safety and Tolerability of PXT3003|"The Primary Objective is to assess the clinical and laboratory safety and tolerability of three doses of PXT3003 administered orally for 12 months to CMT1A patients versus placebo.
Number of participants with adverse events in each arm."|Screening, randomization, 1-, 3-, 6-, 9-, 12-month treatment and 1-month follow-up|||Participants|||Count of Participants
694435|NCT01401166|Secondary|Percentage of Participants With Anti-Trastuzumab or Anti-Recombinant Human Hyaluronidase (rHuPH20) Antibodies|Participants in Cohort 1 provided blood samples for immunogenicity testing to assess for anti-drug antibodies (ADAs) to trastuzumab or rHuPH20, a component of the SC Herceptin formulation. The percentage of participants who were trastuzumab ADA-positive and the percentage of participants who were rHuPH20 ADA-positive were each reported.|Baseline, pre-dose (0 hours) during Cycle 5 (cycle length of 3 weeks)|Safety Population. Results were planned to be analyzed for only Cohort 1 because the objective of the study was to evaluate immunogenicity within participants who received the SID formulation of Herceptin. The number of participants who provided ADA samples at each timepoint (n) is shown in the table.||percentage of participants|||Number
694452|NCT01401153|Primary|Immediate Block Span|Longest sequence correctly reproduced in at least two of three items (the test is a task of reproducing prescribed sequences from two to eight blocks)|Participants were tested twice with one week wash out (1h after having/skipping lunch)|Complete case analysis||Longest sequence correctly reproduced||Inter-Quartile Range|Median
694453|NCT01401153|Primary|Tonic Alertness (Omission Errors)|Stimuli to which no reaction follows within 1.5s|Participants were tested twice with one week wash out (1h after having/skipping lunch)|Complete case analysis||Omission errors||Inter-Quartile Range|Median
694436|NCT01401166|Secondary|"Percentage of Participants With Responses of Agree or Strongly Agree on the SC SID Satisfaction Questionnaire"|Participants who performed self-administration of SC Herceptin via SID were given an evaluation questionnaire during the continuation period (Weeks 25 to 52) after their first self-administration. Participants responded to 5 statements about their comfort with self-injection, the convenience of the SID, their self-confidence using the SID, their satisfaction with the SID, and whether they would consider using the SID again in the future. Each statement used a 5-item rating scale with responses from “Strongly Disagree” to “Strongly Agree”. The percentage of participants with a positive response (either “Agree” or “Strongly Agree”) to each questionnaire statement was reported.|Immediately following first self-administration of SC Herceptin via SID (once during Weeks 25 to 52)|"Safety Population. The Number of Participants Analyzed reflects those who self-administered SC Herceptin using the SID and completed the SC SID questionnaire. Results were planned to be analyzed for only Cohort 1 because the objective of the study was to evaluate satisfaction among those who self-administered the SID formulation of Herceptin."||percentage of participants|||Number
694437|NCT01401166|Secondary|3-Year EFS Rate|EFS events included local, regional, or distant recurrence of the original breast cancer, occurrence of contralateral breast cancer, or death due to any cause. The proportion of participants without an EFS event (i.e., the EFS rate) and corresponding 95% CI at 3 years after randomization was reported.|Year 3|ITT Population||proportion of participants||95% Confidence Interval|Number
694438|NCT01401166|Secondary|Duration of EFS According to Kaplan-Meier Estimate|EFS was defined as the time from randomization to a local, regional, or distant recurrence of the original breast cancer, occurrence of contralateral breast cancer, or death due to any cause. The median duration of EFS and corresponding 95 percent (%) CI according to Kaplan-Meier estimates were planned to be reported and expressed in months.|From Baseline until time of event; assessed every 6 months (median follow-up of 3 years)|ITT Population||months||95% Confidence Interval|Median
694439|NCT01401166|Secondary|Percentage of Participants With an Event-Free Survival (EFS) Event|EFS events included local, regional, or distant recurrence of the original breast cancer, occurrence of contralateral breast cancer, or death due to any cause. The percentage of participants who had an EFS event at any time on study was reported.|From Baseline until time of event; assessed every 6 months (median follow-up of 3 years)|ITT Population||percentage of participants|||Number
694440|NCT01401166|Secondary|Percentage of HCPs by Time Required to Perform Each Method of Drug Administration|"The time required to perform each method of drug administration was assessed via questionnaire with each HCP by asking to rate the amount of time it took to administer each method of drug administration (IV or SC Herceptin) at the end of the crossover period (Week 24). Time was rated in the following time block categories: less than (<) 5 minutes, 6 to 10 minutes, 11 to 15 minutes, 16 to 20 minutes, and greater than (>) 20 minutes. Responses of Not Sure and Unknown were also allowed. The percentage of HCPs who rated the amount of time in each of the categories was reported."|Week 24|HCP Population. Results were planned to be analyzed for all HCPs combined because the objective of the study was to compare HCP perceived time savings with use of SC over IV Herceptin.||percentage of HCPs|HCPs||Number
694441|NCT01401166|Secondary|Percentage of HCPs by Most Satisfied Method of Drug Administration|The method of drug administration with which HCPs were most satisfied (IV or SC Herceptin) was assessed via questionnaire with each HCP using the question, “All things considered, with which method of administration were you most satisfied?” at the end of the crossover period (Week 24). The percentage of HCPs who were most satisfied with each method of drug administration was reported.|Week 24|HCP Population: All HCPs who participated in the study and completed the HCP questionnaire. Results were planned to be analyzed for all HCPs combined because the objective of the study was to compare preference between SC and IV Herceptin.||percentage of HCPs|HCPs||Number
694442|NCT01401166|Primary|Percentage of Participants by Preferred Method of Drug Administration|The preferred method of drug administration (IV or SC Herceptin) was assessed in trial-specific telephone interviews with each study participant. Participants were asked, “All things considered, which method of administration did you prefer?” at the end of the crossover period (Week 24). The percentage of participants who preferred each method of drug administration was reported.|Week 24|Intent-to-Treat (ITT) Population: All participants who received both IV and SC Herceptin and who completed the trial-specific telephone interview conducted after the end of the crossover period.||percentage of participants|||Number
694443|NCT01401153|Primary|Mean Time Incorrect Reactions|Mean time to react incorrectly|Participants were tested twice with one week wash out (1h after having/skipping lunch)|Complete case analysis||Seconds||Inter-Quartile Range|Median
694444|NCT01401153|Primary|Mean Time Correct Reactions|Mean time to react correctly|Participants were tested twice with one week wash out (1h after having/skipping lunch)|Complete case analysis||Seconds||Inter-Quartile Range|Median
694445|NCT01401153|Primary|Incorrect Reactions|Number of incorrect reactions|Participants were tested twice with one week wash out (1h after having/skipping lunch)|Complete case analysis||Incorrect reactions||Inter-Quartile Range|Median
694446|NCT01401153|Primary|Number Correct Reactions|Number of correct reactions|Participants were tested twice with one week wash out (1h after having/skipping lunch)|Complete case analysis||Correct reactions||Inter-Quartile Range|Median
694447|NCT01401153|Primary|Percentage Incorrect Reactions|Percentage of incorrect reactions|Participants were tested twice with one week wash out (1h after having/skipping lunch)|Complete case analysis||Incorrect reactions %||Inter-Quartile Range|Median
694448|NCT01401153|Primary|Reactions|Number of total reactions (Subjects have to decide whether a displayed figure is identical with one of four figures shown or not)|Participants were tested twice with one week wash out (1h after having/skipping lunch)|Complete case analysis||Total reactions||Inter-Quartile Range|Median
694449|NCT01401153|Primary|Sequencing Errors|Sequences including all the blocks of a prescribed sequence, but in the wrong order|Participants were tested twice with one week wash out (1h after having/skipping lunch)|Complete case analysis||Sequences with wrong order||Inter-Quartile Range|Median
694450|NCT01401153|Primary|Correct Immediate Block Span|Number of sequences correctly reproduced|Participants were tested twice with one week wash out (1h after having/skipping lunch)|Complete case analysis||Sequences correctly reproduced||Inter-Quartile Range|Median
694451|NCT01401153|Primary|Incorrect Immediate Block Span|Number of sequences incorrectly reproduced|Participants were tested twice with one week wash out (1h after having/skipping lunch)|Complete case analysis||Sequences incorrectly reproduced||Inter-Quartile Range|Median
694458|NCT01401101|Primary|PTSD Symptoms|same as baseline|6 months|Clinician-Administered PTSD Scale (CAPS) severity score: sum of ratings (from 0-4) for frequency and intensity across each of the 17 symptom items for a possible range of 0-136, where a higher score indicated higher severity.||CAPS scores||95% Confidence Interval|Mean
694459|NCT01401101|Primary|PTSD Symptoms|Clinician-Administered PTSD Scale (CAPS) severity score: sum of ratings (from 0-4) for frequency and intensity across each of the 17 symptom items for a possible range of 0-136, where a higher score indicated higher severity.|0 months (baseline)|all patients who completed the assessment||CAPS scores||95% Confidence Interval|Mean
694460|NCT01401062|Primary|Abscopal Response Rate|Defined as the percentage of patients who have responses (complete or partial) outside the irradiated lesions. The abscopal response is assessed at 15 weeks, and confirmed minimum 4 weeks later. The abscopal response is evaluated based on immune-related response criteria (irRC) (Wolchok et al, 2009).|up to 20 weeks|||Participants|||Count of Participants
694461|NCT01401049|Secondary|To Compare Patient Satisfaction With Sedation Including the Recall of Pain.|We hypothesize that we can reject the null hypothesis that results from all 3 arms are from the same sample, and then show (in pair wise tests) that fospropofol is superior to propofol, and not-inferior to propofol plus lidocaine.|2 hours after the end of the procedure.||||||
694462|NCT01401049|Primary|Compare Incidence and Intensity of Pain on Injection That is Caused by Propofol (Lipid Emulsion) Versus the Test Drug Fospropofol.|We hypothesize that we can reject the null hypothesis that results from all 3 arms are from the same sample, and then show (in pair wise tests) that fospropofol is superior to propofol, and not-inferior to propofol plus lidocaine.|2 hours|Due to flooding from Hurricane Sandy at our site, all files and pertinent patient data were lost.|||||
694463|NCT01401023|Primary|Mean (SD) Stool Tigecycline Concentration Level|Fecal samples were obtained from each patient at the end of a dosing interval (trough concentration) on day 3 of tigecycline therapy. Fecal concentrations were determined with the use of a validated high-performance liquid chromatography assay|day 3 of tigecycline therapy|||micrograms/gram||Standard Deviation|Mean
694464|NCT01401023|Primary|Mean (SD) Serum Tigecycline Concentration Level|Blood samples were obtained from each patient at the end of a dosing interval (trough concentration) on day 3 of tigecycline therapy. Serum concentrations were determined with the use of a validated high-performance liquid chromatography assay.|day 3 of tigecycline therapy|||milligram/liter||Standard Deviation|Mean
694465|NCT01401023|Primary|Mean (SD) Minimun Inhibitory Concentration of Tigecycline of Clostridium Difficile Isolates||day 1 stool sample|||milligram/liter||Standard Deviation|Mean
694466|NCT01401023|Primary|Pharmacokinetics of Tigecycline Along With Standard Treatments for Clostridium Difficile|Serum and stool levels of tigecycline|day 3 of treatment||||||
694467|NCT01401010|Primary|Mean (SD) Doripenem Pharmacokinetic (PK) Area Under Serum Curve (mg*h/L) Parameter in Febrile Neutropenic Patients|To determine the serum pharmacokinetic area under serum curve of doripenem in febrile neutropenic patients with pneumonia. We obtained blood at 1, 4, 6, 8 hours after at least two doses of doripenem and measured these levels (mg/L)by HPLC assay.|1, 4, 6, 8 hours after at least two doses of drug|Each subject received drug and had serum samples drawn at 1, 4, 6, 8 hours after dosing.||milligrams * hour/liters||Standard Deviation|Mean
694468|NCT01401010|Primary|Mean (SD) Doripenem Pharmacokinetic (PK) Clearance of Drug Parameter in Febrile Neutropenic Patients|To determine the serum pharmacokinetic clearance of drug of doripenem in febrile neutropenic patients with pneumonia. We obtained blood at 1, 4, 6, 8 hours after at least two doses of doripenem and measured these levels (mg/L)by HPLC assay.|1, 4, 6, 8 hours after at least two doses of drug|Each subject received drug and had serum samples drawn at 1, 4, 6, 8 hours after dosing.||Liters/hour||Standard Deviation|Mean
694469|NCT01401010|Primary|Mean (SD) Doripenem Pharmacokinetic (PK) Half Life Parameter in Febrile Neutropenic Patients|To determine the serum pharmacokinetic half life of doripenem in febrile neutropenic patients with pneumonia. We obtained blood at 1, 4, 6, 8 hours after at least two doses of doripenem and measured these levels (mg/L)by HPLC assay.|1, 4, 6, 8 hours after at least two doses of drug|Each subject received drug and had serum samples drawn at 1, 4, 6, 8 hours after dosing.||hours||Standard Deviation|Mean
694470|NCT01401010|Primary|Mean (SD) Doripenem Pharmacokinetic (PK) Elimination Rate Constant Parameter in Febrile Neutropenic Patients|To determine the serum pharmacokinetic elimination rate constant of doripenem in febrile neutropenic patients with pneumonia. We obtained blood at 1, 4, 6, 8 hours after at least two doses of doripenem and measured these levels (mg/L)by HPLC assay.|1, 4, 6, 8 hours after at least two doses of drug|Each subject received drug and had serum samples drawn at 1, 4, 6, 8 hours after dosing.||hour^-1||Standard Deviation|Mean
694471|NCT01401010|Secondary|Monte Carlo Simulations Tested Against Various Gram-negative Isolates and Reported as Probability of Target Attainment (40% Time (fT) > Minimum Inhibitory Concentrations (MIC))|"Following determination of pharmacokinetic (PK) parameters from patients with febrile neutropenia, Monte Carlo simulations were then conducted to determine time of serum concentrations above the MIC (40% of the time) against Gram-negative isolates.
These Gram-negative isolates had a range of minimum inhibitory concentrations (MIC) to Doripenem."|1, 4, 6, 8 hours after an infusion of doripenem to determine the PK parameters|Each subject received drug and had serum samples drawn at 1, 4, 6, 8 hours after dosing.||probability of target attainment|||Number
694472|NCT01401010|Primary|Mean (SD) Doripenem Pharmacokinetic Volume of Distribution Parameter in Febrile Neutropenic Patients|To determine the serum pharmacokinetic volume of distribution of doripenem in febrile neutropenic patients with pneumonia. We obtained blood at 1, 4, 6, 8 hours after at least two doses of doripenem and measured these levels (mg/L)by HPLC assay.|1, 4, 6, 8 hours after at least two doses of drug|Each subject received drug and had serum samples drawn at 1, 4, 6, 8 hours after dosing.||Liters||Standard Deviation|Mean
694473|NCT01400958|Secondary|Occurrence of Improved Cognitive Performance|Determine if Nuvigil® improves cognitive function of patients receiving external beam radiation therapy for the treatment of malignant gliomas. Participants who maintained average (T=50) to slightly below average (T=40 or greater) cognitive function.|5 months|Available, evaluable participants with average T Score range cognitive function at baseline||participants|||Number
694474|NCT01400958|Primary|Occurrence of Improved Fatigue Experience After Treatment|Determine if Nuvigil® improves fatigue experienced by patients receiving external beam radiation therapy for the treatment of malignant gliomas. Participants who maintained minimal, or experienced improved fatigue experience on a scale of 0 (No fatigue) - 10 (As bad as you can imagine).|5 months|Available, evaluable participants with minimal fatigue at baseline||participants|||Number
694475|NCT01400932|Secondary|Mean Change From Baseline in Itching and Burning/Stinging Scores at Weeks 1, 2, 4, 8, 12/Withdrawal|Itching and burning/stinging were evaluated by the participant as: 0 (none)=normal, no discomfort; 1 (slight)=noticeable discomfort that caused intermittent awareness; 2 (mild)=noticeable discomfort that caused continuous awareness; 3 (moderate)=noticeable discomfort that caused intermittent awareness and interfered occasionally with normal daily activities; 4 (severe)=definite continuous discomfort that interfered with normal daily activities. Change from Baseline was calculated as the post-Baseline/Withdrawal value minus the Baseline value.|Baseline; Weeks 1, 2, 4, 8, 12 or withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points/for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||Scores on a scale||Standard Deviation|Mean
694476|NCT01400932|Secondary|Mean Change From Baseline in Erythema, Dryness, and Peeling Scores at Weeks 1, 2, 4, 8, 12/Withdrawal|Erythema (redness), dryness, and peeling were evaluated independently by the investigator as: 0 (absent)=no erythema, dryness, or peeling; 1 (slight)=faint red/pink coloration, barely perceptible dryness with no flakes or fissure, mild localized peeling; 2 (mild)=light red/pink coloration, perceptible dryness with no flakes/fissure, mild and diffuse peeling; 3 (moderate)=medium red coloration, easily noted dryness and flakes but no fissure, moderate and diffuse peeling; 4 (severe)=beet red coloration, dryness with flakes and fissure, prominent dense peeling. Change from Baseline was calculated as the post-Baseline/Withdrawal value minus the Baseline value.|Baseline; Weeks 1, 2, 4, 8, 12 or Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points/for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||Scores on a scale||Standard Deviation|Mean
694477|NCT01400932|Secondary|Number of Participants Who Had a Reduction in Total Lesions of at Least 50% From Baseline to Weeks 1, 2, 4, 8, and 12|The proportion of participants who have a reduction in total lesions (inflammatory and non-inflammatory) of at least 50% from Baseline at Weeks 1, 2, 4, 8, and 12 was measured.|Baseline; Weeks 1, 2, 4, 8, and 12|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Participants|||Number
694478|NCT01400932|Secondary|Number of Participants Who Had an ISGA Score of 0 or 1 at Weeks 1, 2, 4, 8, and 12|Investigators evaluated the acne severity of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no inflammatory lesions (ILs) or non-inflammatory lesions (NILs); 1=almost clear: rare NILs with no more than rare papules; 2=mild acne: greater than Grade 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate acne: greater than Grade 2, up to many NILs and had some ILs, but no more than one small NL; 4=severe acne: greater than Grade 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe acne: many NILs and ILs and more than a few NLs, had cystic lesions.|Weeks 1, 2, 4, 8, and 12|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Participants|||Number
694479|NCT01400932|Secondary|Number of Participants Who Had a Minimum 2-grade Improvement in the Investigator’s Static Global Assessment (ISGA) Score From Baseline to Week 12|Investigators evaluated the acne severity of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no inflammatory lesions (ILs) or non-inflammatory lesions (NILs); 1=almost clear: rare NILs with no more than rare papules; 2=mild acne: greater than Grade 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate acne: greater than Grade 2, up to many NILs and had some ILs, but no more than one small NL; 4=severe acne: greater than Grade 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe acne: many NILs and ILs and more than a few NLs, had cystic lesions.|Baseline and Week 12|ITT Population. Only those participants with data available at the specified time point were analyzed.||Participants|||Number
694480|NCT01400932|Secondary|Percent Change From Baseline in Total, Inflammatory, and Non-inflammatory Lesion Counts to Weeks 1, 2, 4, 8, and 12|The percent change from Baseline to Weeks 1, 2, 4, 8, and 12 in lesion counts (total [inflammatory and non-inflammatory], inflammatory [IL], and non-inflammatory [NIL]) was analyzed using an ANOVA model with terms for treatment and center. Percent change from Baseline was calculated as: (post-Baseline value minus Baseline value) * 100.|Baseline; Weeks 1, 2, 4 and 8 and 12|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Percent change in lesion counts||Standard Error|Least Squares Mean
694481|NCT01400932|Secondary|Absolute Change From Baseline in Inflammatory Lesion (IL) Count and Non-inflammatory Lesion (NIL) Count to Weeks 1, 2, 4, 8, and 12|The investigator/subinvestigator counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedo) on the face at each study visit. An open comedo is an open, widely dilated follicle with black-colored sebum, due to melanin and oxidation, and keratinous material that forms a plug, thereby obstructing the pilosebaceous duct. A closed comedo is a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule is a small, raised, red, dome-shaped palpable lesion. A pustule is a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule may be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter. Data were analyzed using an ANCOVA model with terms for Baseline value, treatment, and center.|Baseline; Weeks 1, 2, 4, 8, and 12|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Lesion counts||Standard Error|Least Squares Mean
694499|NCT01400841|Secondary|Cardiac Output - Change From Baseline|Stroke volume x heart rate. Transthoracic echocardiography parameter.|Baseline, 2 years postprocedure (extended follow-up)|Both baseline and 2-year measure available for 5 of 11 participants.||l/min||Standard Deviation|Mean
707215|NCT00121225|Primary|Objective Response Rate Assessed by Response Evaluation Criteria for Solid Tumors (RECIST)||Up to 5 years|||participants|||Number
694482|NCT01400932|Secondary|Absolute Change in Total Lesion Counts From Baseline to Weeks 1, 2, 4, and 8|The investigator/subinvestigator counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedo) on the face at each study visit. An open comedo is an open, widely dilated follicle with black-colored sebum, due to melanin and oxidation, and keratinous material that forms a plug, thereby obstructing the pilosebaceous duct. A closed comedo is a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule is a small, raised, red, dome-shaped palpable lesion. A pustule is a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule may be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter.Data were analyzed using an ANCOVA model with terms for Baseline value, treatment, and center.|Baseline; Weeks 1, 2, 4, and 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Lesion counts||Standard Error|Least Squares Mean
694483|NCT01400932|Primary|Absolute Change in Total Lesion Counts From Baseline to Week 12|The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedos; diagnosis based on palpation) on the face at each study visit. An open comedo is an open, widely dilated follicle with black-colored sebum, due to melanin and oxidation, and keratinous material that forms a plug, thereby obstructing the pilosebaceous duct. A closed comedo is a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule is a small, raised, red, dome-shaped palpable lesion. A pustule is a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule may be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter.|Baseline and Week 12|Intent-to-Treat (ITT) Population: all randomized participants who received at least one application of investigational product. Only those participants with data available at the specified time point were analyzed. Analysis was based on an analysis of covariance (ANCOVA) model with terms for Baseline value, treatment, and center.||Lesion counts||Standard Error|Least Squares Mean
694484|NCT01400919|Primary|Major Adverse Event Rate||9 months|||percentage of participants|||Number
694485|NCT01400906|Secondary|Neutrophil and Eosinophil Cell Counts in Induced Sputum on Day 7 of Each Treatment Period|Sputum induction was performed using hypertonic saline solution to collect an adequate sample of secretions from lungs. The collected sputum was analyzed for neutrophil and eosinophil counts. Sputum induction was performed after methacholine challenge and post-dose administration on Day 7. Zero values are imputed to 0.001 for this analysis. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.|Day 7 of each treatment period (up to 11 weeks)|PD Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the PD Population.||10^4 cells per gram of sputum||95% Confidence Interval|Geometric Mean
694486|NCT01400906|Primary|LAR - Non-smokers: Absolute Change From Saline in WM FEV1 Between 4-10 Hrs Following Post-treatment Allergen Challenge on Day 6 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 1 hour after dosing on Day 6. The WM FEV1 was derived by calculating the area under the curve, and then dividing the value by the relevant time interval. LAR WM FEV1 was measured at 4 hrs, 4.5 hrs, 5 hrs, 5.5 hrs, 6 hrs, 6.5 hrs, 7 hrs, 7.5 hrs, 8 hrs, 8.5 hrs, 9 hrs, 9.5 hrs, and 10 hrs post-allergen challenge on Day 6. Absolute change from saline at each time point was calculated as the highest allergen challenge FEV1 value minus the highest saline FEV1 value. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.|Day 6 of each treatment period (up to 11 weeks)|PD Population. Only those participants were non-smokers were analyzed.||Liters||95% Confidence Interval|Least Squares Mean
694487|NCT01400906|Primary|LAR - Smokers: Absolute Change From Saline in Weighted Mean (WM) FEV1 Between 4-10 Hrs Following Post-treatment Allergen Challenge on Day 6 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 1 hour after dosing on Day 6. The WM FEV1 was derived by calculating the area under the curve, and then dividing the value by the relevant time interval. LAR WM FEV1 was measured at 4 hrs, 4.5 hrs, 5 hrs, 5.5 hrs, 6 hrs, 6.5 hrs, 7 hrs, 7.5 hrs, 8 hrs, 8.5 hrs, 9 hrs, 9.5 hrs, and 10 hrs post-allergen challenge on Day 6. Absolute change from saline at each time point was calculated as the highest allergen challenge FEV1 value minus the highest saline FEV1 value. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.|Day 6 of each treatment period (up to 11 weeks)|PD Population. Only those participants who were smokers were analyzed.||Liters||95% Confidence Interval|Least Squares Mean
694488|NCT01400906|Primary|LAR - Non-smokers: Absolute Change From Saline in Minimum FEV1 Between 4-10 Hours (Hrs) After Allergen Challenge on Day 6 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 1 hr after dosing on Day 6. Minimum FEV1 over 4-10 hours post-allergen challenge is the minimum value of all of the post-saline time points between 4 and 10 hrs post-allergen challenge, inclusive of the 4 hr and 10 hr timepoints (i.e., minimum over 4 hrs, 4.5 hrs, 5 hrs, 5.5 hrs, 6 hrs, 6.5 hrs, 7 hrs, 7.5 hrs, 8 hrs, 8.5 hrs, 9 hrs, 9.5 hrs, and 10 hrs). Absolute change from saline at each time point was calculated as the highest allergen challenge FEV1 value minus the highest saline FEV1 value. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.|Day 6 of each treatment period (up to 11 weeks)|PD Population. Only those participants who were non-smokers were analyzed.||Liters||95% Confidence Interval|Least Squares Mean
694500|NCT01400841|Secondary|Cardiac Output - Change From Baseline|Stroke volume x heart rate. Transthoracic echocardiography parameter.|Baseline, 6 months postprocedure|Both baseline and 6-month measure available for 7 of 15 participants.||l/min||Standard Deviation|Mean
699997|NCT00033371|Secondary|Percent Change in Polyp Size in Focal Area(s) of the Colorectum|The two-sample t-test or its non-parametric analogue, the Wilcoxon rank sums test will be used.|Baseline up to 2 months after completion of study treatment||||||
694489|NCT01400906|Secondary|Concentration of Exhaled Nitric Oxide (eNO) on Day 6 and Day 7 of Each Treatment Period|The concentration of eNO was measured on Day 6 pre-dose and on Day 7 post-study medication administration. eNO was measured 3 times at each time point, and all 3 measurements were recorded. The mean of the 3 measurements was calculated and was used in the derivation of summary statistics.|Day 6 and Day 7 of each treatment period (up to 11 weeks)|PD Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PD Population.||Parts per billion||Standard Deviation|Mean
694490|NCT01400906|Secondary|Provocative Concentration of Methacholine Resulting in a 20% Reduction in FEV1 (PC20) on Day 7 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants inhaled doubling increments of methacholine until a >=20% decrease in FEV1 from the post-saline value was achieved.|Day 7 of each treatment period (up to 11 weeks)|PD Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the PD Population.||milligrams per milliliter||95% Confidence Interval|Geometric Mean
694491|NCT01400906|Secondary|Absolute Change From Baseline in FEV1 Post-dose on Day 1, Day 6 (Prior to Allergen Challenge), and Day 7|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Baseline FEV1 was measured on Day 1 pre-dose administration. FEV1 was measured on Day 1 post-dose, on Day 6 (prior to allergen challenge), and on Day 7 pre dose administration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.|Baseline, Day 1, Day 6, and Day 7|PD Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PD Population.||Liters||95% Confidence Interval|Least Squares Mean
694492|NCT01400906|Secondary|Early Asthmatic Response (EAR): Absolute Change From Saline in Minimum FEV1 and WM FEV1 Between 0-2 Hours (Hrs) After Allergen Challenge on Day 6 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 1 hr after dosing on Day 6. Minimum FEV1 over 0-2 hrs post-allergen challenge (Minimum EAR) is the minimum value of all of the post-allergen challenge timepoints up to and including 2 hours post-allergen challenge (i.e., minimum over 5 minutes [min], 10 min, 15 min, 20 min, 30 min, 45 min and 1 hr, 1.5 hrs, and 2 hrs). The WM FEV1 was derived by calculating the area under the curve, and then dividing the value by the relevant time interval. Absolute change from saline at each time point was calculated as the highest allergen challenge FEV1 value minus the highest saline FEV1 value. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.|Day 6 of each treatment period (up to 11 weeks)|PD Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the PD Population.||Liters||95% Confidence Interval|Least Squares Mean
694493|NCT01400906|Primary|Late Asthmatic Response (LAR) - Smokers: Absolute Change From Saline in Minimum Forced Expiratory Volume in One Second (FEV1) Between 4-10 Hours (Hrs) After Allergen Challenge on Day 6 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 1 hr after dosing on Day 6. Minimum FEV1 over 4-10 hours post-allergen challenge is the minimum value of all of the post-saline time points between 4 and 10 hrs post-allergen challenge, inclusive of the 4 hr and 10 hr timepoints (i.e., minimum over 4 hrs, 4.5 hrs, 5 hrs, 5.5 hrs, 6 hrs, 6.5 hrs, 7 hrs, 7.5 hrs, 8 hrs, 8.5 hrs, 9 hrs, 9.5 hrs, and 10 hrs). Absolute change from saline at each time point was calculated as the highest allergen challenge FEV1 value minus the highest saline FEV1 value. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.|Day 6 of each treatment period (up to 11 weeks)|Pharmacodynamic (PD) Population: all participants in the All Subjects Population (all participants who received at least one dose of study medication) who had a post-dose FEV1 assessment in the same period. Only those participants who were smokers were analyzed.||Liters||95% Confidence Interval|Least Squares Mean
694494|NCT01400893|Secondary|Renal Replacement Therapy Dependency at Day 60.|RRT dependency at day 60 is defined as patient not receiving any form of intermittent or continuous renal replacement therapy at 60 days post enrollment in the study with no plans for additional intermittent or continuous renal replacement therapy.|Day 60 following treatment initiation|per protocol.||Participants|||Count of Participants
694495|NCT01400893|Primary|The Primary Clinical Efficacy Endpoint in This Trial is All Cause Mortality Through 60 Days Post-randomization.|"All cause mortality through day 60 post-randomization.
The outcome data reported here describe the mortality at Day 60 (primary endpoint) of the treated subjects which received the recommended ionized calcium (riCa) for ≥ 90% of treatment time."|Day 60 following treatment initiation|Outcome data is reported for those subjects in which the calcium levels were maintained in the protocol's recommended range (≤0.4 mmol/L) for greater or equal to 90% of the therapy time.||Participants|||Count of Participants
694496|NCT01400880|Primary|Comparison of Electrode Sensor and TOCO Detection of Contraction Events, as Compared to IUPC|Contraction timing as measured by the electrode sensor and contraction timing as measure by the TOCO, both compared to the contraction timing as measured by the IUPC gold standard. The contraction timing values of the electrode sensor and TOCO were then compared.|Stage I and II Labor|Pregnant women between the ages of 18-50 with a single viable fetus in stages I and/or II of labor||seconds||Standard Deviation|Mean
694497|NCT01400841|Secondary|Cardiac Index - Change From Baseline|Hemodynamic parameter computed as cardiac output divided by body surface area|Baseline, 2 years postprocedure (extended follow-up)|Both baseline and 2-year measure available for 5 of 11 participants.||l/min/m^2||Standard Deviation|Mean
694501|NCT01400841|Secondary|LVEF - Change From Baseline|Left ventricular ejection fraction. Transthoracic echocardiography parameter.|Baseline, 2 years postprocedure (extended follow-up)|Both baseline and 2-year measure available for 5 of 11 participants.||percentage of blood volume||Standard Deviation|Mean
694502|NCT01400841|Secondary|LVEF - Change From Baseline|Left ventricular ejection fraction. Transthoracic echocardiography parameter.|Baseline, 6 months postprocedure|Both baseline and 6-month measure available for 7 of 15 participants.||percentage of blood volume||Standard Deviation|Mean
694503|NCT01400841|Secondary|LV Systolic Volume - Change From Baseline|Left ventricular systolic volume. Transthoracic echocardiography parameter.|Baseline, 2 years postprocedure (extended follow-up)|Both baseline and 2-year measure available for 5 of 11 participants.||ml||Standard Deviation|Mean
694504|NCT01400841|Secondary|LV Systolic Volume - Change From Baseline|Left ventricular systolic volume. Transthoracic echocardiography parameter.|Baseline, 6 months postprocedure|Both baseline and 6-month measure available for 7 of 15 participants.||ml||Standard Deviation|Mean
694505|NCT01400841|Secondary|LV Diastolic Volume - Change From Baseline|Left ventricular diastolic volume. Transthoracic echocardiography parameter.|Baseline, 2 years postprocedure (extended follow-up)|Both baseline and 2-year measure available for 5 of 11 participants.||ml||Standard Deviation|Mean
694506|NCT01400841|Secondary|LV Diastolic Volume - Change From Baseline|Left ventricular diastolic volume. Transthoracic echocardiography parameter.|Baseline, 6 months postprocedure|Both baseline and 6-month measure available for 7 of 15 participants.||ml||Standard Deviation|Mean
694507|NCT01400841|Secondary|LVID Systole - Change From Baseline|Left ventricular internal dimension. Transthoracic echocardiography parameter.|Baseline, 2 years postprocedure (extended follow-up)|Both baseline and 2-year measure available for 3 of 11 participants.||cm||Standard Deviation|Mean
694508|NCT01400841|Secondary|LVID Systole - Change From Baseline|Left ventricular internal dimension. Transthoracic echocardiography parameter.|Baseline, 6 months postprocedure|Both baseline and 6-month measure available for 5 of 15 participants.||cm||Standard Deviation|Mean
694509|NCT01400841|Secondary|LVID Diastole - Change From Baseline|Left ventricular internal dimension. Transthoracic echocardiography parameter.|Baseline, 2 years postprocedure (extended follow-up)|Both baseline and 2-year measure available for 7 of 11 participants.||cm||Standard Deviation|Mean
694510|NCT01400841|Secondary|LVID Diastole - Change From Baseline|Left ventricular internal dimension. Transthoracic echocardiography parameter.|Baseline, 6 months postprocedure|Both baseline and 6-month measure available for 8 of 15 participants.||cm||Standard Deviation|Mean
694511|NCT01400841|Secondary|LV Mass - Change From Baseline|Left ventricular mass. Transthoracic echocardiography parameter.|Baseline, 2 years postprocedure (extended follow-up)|Both baseline and 2-year measure available for 6 of 11 participants.||g||Standard Deviation|Mean
694512|NCT01400841|Secondary|LV Mass - Change From Baseline|Left ventricular mass. Transthoracic echocardiography parameter.|Baseline, 6 months postprocedure|Both baseline and 6-month measure available for 8 of 15 participants||g||Standard Deviation|Mean
694513|NCT01400841|Secondary|Mean Gradient - Change From Baseline|Transthoracic echocardiography parameter|Baseline, 2 years postprocedure (extended follow-up)|Baseline measure not available for 1 of 11 participants.||mm Hg||Standard Deviation|Mean
694514|NCT01400841|Secondary|Mean Gradient - Change From Baseline|Transthoracic echocardiography parameter|Baseline, 6 months postprocedure|Baseline measure not available for 1 of 15 participants.||mm Hg||Standard Deviation|Mean
694515|NCT01400841|Secondary|Peak Gradient - Change From Baseline|Transthoracic echocardiography parameter|Baseline, 2 years postprocedure (extended follow-up)|Baseline measure not available for 1 of 11 participants.||mm Hg||Standard Deviation|Mean
694516|NCT01400841|Secondary|Peak Gradient - Change From Baseline|Transthoracic echocardiography parameter|Baseline, 6 months postprocedure|Baseline measure not available for 1 of 15 participants.||mm Hg||Standard Deviation|Mean
694517|NCT01400841|Secondary|New York Heart Association (NYHA) Functional Capacity Classification|Four classes describing the effect of cardiac disease on physical activity: Class I - disease does not limit activity; Class II - slight limitation; Class III - marked limitation; Class IV - inability to carry out any physical activity without discomfort|2 years postprocedure (extended follow-up)|||participants|||Number
694518|NCT01400841|Secondary|New York Heart Association (NYHA) Functional Capacity Classification|Four classes describing the effect of cardiac disease on physical activity: Class I - disease does not limit activity; Class II - slight limitation; Class III - marked limitation; Class IV - inability to carry out any physical activity without discomfort|6 months postprocedure|NYHA evaluation not done on 1 of 15 participants||participants|||Number
694519|NCT01400841|Secondary|Event-free Survival|Event-free survival is defined as survival free from device-related death|6 months postprocedure|||percentage of participants||95% Confidence Interval|Number
694520|NCT01400841|Secondary|Actuarial Freedom From Clinical Cardiovascular Events|"Freedom from specified clinical cardiovascular events 2 years postprocedure:
Device-related mortality
Complete heart block
Structural device failure
Endocarditis
Periprosthetic leak or dehiscence
Thromboembolism
Bleeding Event
Native Valve Deterioration
Valve Thrombosis
Hemolysis
Reoperation and explant at 2 years"|2 years postprocedure|||percentage of implant procedures||95% Confidence Interval|Number
694521|NCT01400841|Secondary|Actuarial Freedom From Clinical Cardiovascular Events|"Freedom from specified clinical cardiovascular events 1 month postprocedure:
Device-related mortality
Complete heart block
Structural device failure
Endocarditis
Periprosthetic leak or dehiscence
Thromboembolism
Bleeding Event
Native Valve Deterioration
Valve Thrombosis
Hemolysis
Reoperation and explant at 1 month"|1 month postprocedure|||percentage of implant procedures||95% Confidence Interval|Number
694522|NCT01400841|Secondary|Implant Procedure Success|"Success is defined as the absence of specified adverse events evaluated through discharge or 14 days after the procedure:
Aortic annular dissection, rupture, or leaflet damage
Paravalvular leak > +2 or requiring intervention
Mitral valve impingement due to implant
implant dehiscence/migration into aorta
implant dehiscence/migration into left ventricle
Hemodynamics requiring intervention
Other adverse event resulting in reoperation, explantation, or permanent disability."|2 years postprocedure (extended follow-up)|||percentage of implant procedures||95% Confidence Interval|Number
694620|NCT01399619|Secondary|The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment (EoT) When SVR12=Yes|The number of participants with Alanine Aminotransferase (ALT) normalisation at End of Treatment (EoT) when SVR12=yes. BL stands for baseline.|48 weeks|FAS||participants|||Number
694523|NCT01400841|Secondary|Implant Procedure Success|"Success is defined as the absence of specified adverse events evaluated through discharge or 14 days after the procedure:
Aortic annular dissection, rupture, or leaflet damage
Paravalvular leak > +2 or requiring intervention
Mitral valve impingement due to implant
implant dehiscence/migration into aorta
implant dehiscence/migration into left ventricle
Hemodynamics requiring intervention
Other adverse event resulting in reoperation, explantation, or permanent disability."|discharge or 14 days postprocedure, whichever comes first|||percentage of implant procedures||95% Confidence Interval|Number
694524|NCT01400841|Primary|Primary Efficacy Outcome Measure: Aortic Valvular Regurgitation at 2 Years Postprocedure|Aortic valvular regurgitation assessed by transthoracic echocardiography and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+)|2 years postprocedure (extended follow-up)|||participants|||Number
694525|NCT01400841|Primary|Primary Efficacy Outcome Measure: Aortic Valvular Regurgitation at 6 Months Postprocedure|Aortic valvular regurgitation assessed by transthoracic echocardiography and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+)|6 months postprocedure|||participants|||Number
694526|NCT01400841|Primary|Primary Safety Outcome Measure: Event-free Survival|Event-free survival is defined as survival free from device-related death|2 years postprocedure (extended follow-up)|Extended follow-up participants||percentage of participants||95% Confidence Interval|Number
694527|NCT01400841|Primary|Primary Safety Outcome Measure: Event-free Survival|Event-free survival is defined as survival free from device-related death|1 month postprocedure|||percentage of participants||95% Confidence Interval|Number
694528|NCT01400698|Post-Hoc|Duration of Participation in the Study||Up to 10.6 years|ITT population included all participants enrolled in this study. Safety population was identical in this study. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluated for this measure.||years||Standard Deviation|Mean
694529|NCT01400698|Post-Hoc|Duration of Treatment||Up to 10.6 years|ITT population included all participants enrolled in this study. Safety population was identical in this study. Here, ‘N’ (number of participants analyzed) signifies those participants who were treated and hence, were evaluated for this measure.||years||Standard Deviation|Mean
694530|NCT01400698|Secondary|Parental Adjusted Height Standard Deviation Score (PAHSDS)|PAHSDS is the distance between the participant’s current and target heights, expressed in units of SD of the height distribution of the reference population. Target height is a measure of the height which the participant could hypothetically reach based only on his parents’ heights. Target height standard deviation score (THSDS) was calculated as target height minus mean adult height of the reference population divided by SD of the mean adult height of the reference population.|One year after final height was attained up to 10.6 years|ITT population included all participants enrolled in this study. Safety population was identical in this study.||standard deviation score||Standard Deviation|Mean
694531|NCT01400698|Primary|Height Standard Deviation Score (HSDS)|HSDS was calculated as height minus reference mean height divided by SD of the reference mean height, both given by the reference growth table (Sempe) for the corresponding chronological age at the height measurement. Greater HSDS indicate greater height. (Sempe M et al., 1979)|One year after final height was attained up to 10.6 years|ITT population included all participants enrolled in this study. Safety population was identical in this study.||standard deviation score||Standard Deviation|Mean
694532|NCT01400698|Primary|Final Height|Final height was defined as the height reached 1 year after height velocity (HV) was less than 2 centimeter/year (cm/year). Height velocity was the change in height since the previous year’s measurement. Height was measured with a wall-mounted stadiometer (or in supine position if the participant’s age was less than 3 years) and the measurement was repeated thrice by the same observer. The mean of the values obtained in the repeated measurements was taken for the analysis.|One year after final height was attained up to 10.6 years|Intention-to-treat (ITT) population included all participants enrolled in this study. Safety population was identical in this study.||cm||Standard Deviation|Mean
694533|NCT01400516|Secondary|Change From Baseline in Disease Activity Score 28 Joint Count C-Reactive Protein (DAS-28 CRP)|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and C-Reactive Protein (CRP) for a total possible score of 2 to 10. Higher values indicate higher disease activity. A negative change from baseline indicates improvement.|Baseline and Month 12|Analysis includes 24 participants who were randomized, 2 participants withdrew prematurely and are not included.||score on a scale||Standard Deviation|Mean
694534|NCT01400516|Secondary|Change From Baseline in Bone Mineral Density (BMD) Measured by Dual-Energy X-ray Absorptiometry (DXA) and Instant Vertebral Assessment (IVA) Scan|BMD was measured at the lumbosacral spine antero-posterior and at the femoral neck using a densitometer. A positive change from Baseline (increased bone density) indicates improvement.|Baseline and Month 12|Analysis includes 24 participants who were randomized, 2 participants withdrew prematurely and are not included.||grams/centimeters squared (g/cm^2)||Standard Deviation|Mean
694535|NCT01400516|Primary|Change From Baseline in Joint Erosion Volume Measured by 3-Dimensional Computed Tomography (3D CT) Scan|Both hands were scanned using a CT scanner. A semi-automated software tool was used to segment the erosion margins in 3D. A board certified radiologist identified the individual erosions in six sub-regions: radius, ulna, proximal carpals, distal carpals, metacarpophalangeal (MCP) joints and proximal interphalangeal (PIP) joints. The average total in a single hand/wrist was calculated. A negative change from Baseline(less joint erosions) indicates improvement.|Baseline and Month 12|Analysis includes 24 participants who were randomized, 2 participants withdrew prematurely and are not included.||cubic millimeter (mm^3)||Inter-Quartile Range|Median
694559|NCT01400412|Secondary|Percentage Change in Expression of CD38+/HLA-DR+ on CD4+ T Cells From Baseline to Week 48|percentage change is define as [ (week 48 - week 0) / week 0 ] * 100%|At weeks 0 and 48|As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks.||percentage change||Inter-Quartile Range|Median
694560|NCT01400412|Secondary|CD8+ T-cell Change From Baseline to Week 48||At weeks 0 and 48|As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks.||cell/mm^3||Inter-Quartile Range|Median
694536|NCT01400451|Primary|Number of Participants With Hepatic Dose Limiting Toxicities (DLT) in Participants Treated With Concurrent Ipilimumab and Vemurafenib|DLT defined as a >= Grade 3 drug-related AE during induction with ipilimumab in combination with vemurafenib excluding: Grade 3 AE of tumor flare (defined as local pain, irritation, or rash localized at sites of known or suspected tumor); Grade 3 cutaneous squamous cell carcinoma; Grade 3 photosensitivity that resolved to a Grade 1 or baseline within 15 days; Grade 3 immune-mediated events of the skin (rash, pruritis) or endocrine systems (hypothyroidism, hyperthyroidism, hypopituitarism, adrenal insufficiency, hypogonadism and cushingoid) that resolved to a Grade 1 or baseline within 28 days; a transient (resolving within 6 hours of onset) Grade 3 infusion-related AE. Hepatic=elevated aspartate aminotransferase and alanine aminotransferase. Maximum tolerable dose (MTD) was defined as the maximum dose of combination treatment that could be given to 6 subjects such that no more than 2 subjects experience DLT. Day 1=first day of concurrent therapy with ipilimumab and vemurafenib.|Day 1 to last dose of drug + 90 (approximately 2 years)|All participants who received at least one dose of concurrent study drugs.||participants|||Number
694537|NCT01400451|Primary|During the Combination Treatment Period: Number of Participants With Adverse Events (AEs), AEs Leading to Drug Discontinuation, Serious Adverse Events (SAEs), and Deaths in Participants Treated With Concurrent Ipilimumab and Vemurafenib|AEs graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling, Gr 5=Death. Related=relationship to study drug reported as certain, probable, possible, or missing. AEs: onset on or after ipilimumab start and within 90 days of last dose. Immune-related AEs (irAEs) characterized by potential association with inflammation and considered by investigator as drug related. Day 1=first dose of ipilimumab.|Combination drugs: Day 1 to last dose of drug + 90 days (approximately 2 years)|All participants who received at least one dose of study drug.||participants|||Number
694538|NCT01400451|Primary|During the Lead In Period: Number of Participants With Adverse Events (AEs), AEs Leading to Drug Discontinuation, Serious Adverse Events (SAEs), and Deaths in Participants Treated With Vemurafenib Alone|AEs graded using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling, Gr 5=Death. Related=relationship to study drug reported as certain, probable, possible, or missing. Immune-related AEs (irAEs) characterized by potential association with inflammation and considered by investigator as drug related. Lead In Period: between the first vemurafenib dose and the day prior to the first ipilimumab dose.|From first vemurafenib dose to day prior to first ipilimumab dose (28 days); Patients who never progressed from Lead-in to combination treatment (720 mg Alone): first dose to last dose + 90 days (approximately 2 years)|All participants who received at least one dose of study drug.||participants|||Number
694539|NCT01400425|Other Pre-specified|Percentage of Subjects Who Undergo a Hypothetical Change in Clinical Diagnosis After Obtaining a Florbetapir F 18 PET Scan.|The impact of a florbetapir F 18 PET scan on a physician's clinical diagnosis of a subject was evaluated on a hypothetical basis because at the start of this study Florbetapir F 18 was an investigational drug and the data collected is for research purposes only. The percentage of subjects who received a florbetapir scan that led to a change in hypothetical clinical diagnosis is presented below.|6 weeks|Subjects who have received a florbetapir scan (either positive or negative).||Percentage of subjects||95% Confidence Interval|Number
694540|NCT01400425|Secondary|Change in Physician Management Plans|Determine the percentage of subjects that had at least one hypothetical change between pre and post scan physician management plans. Change in management is defined as the number of subjects prescribed different item-wise plans at the two assessments divided by the total number of subjects in the population with both a pre and post florbetapir F 18 PET scan physician management plan.|6 weeks|All subjects with progressive cognitive decline who have received a florbetapir scan.||Percentage of subjects||95% Confidence Interval|Number
694541|NCT01400425|Secondary|Change in Confidence of the Clinical Diagnosis|Change in confidence of the clinical diagnosis prior to obtaining a florbetapir F 18 PET scan to the confidence after obtaining a florbetapir F 18 PET scan among subjects in whom the clinical diagnosis remains unchanged. Confidence levels were self-determined by physicians based on their diagnostic certainty and ranged from 0-100%. The mean (SD) change in confidence reflects the average change in diagnostic confidence along the 0-100% scale for the 62 subjects analyzed.|6 weeks|The hypothetical clinical diagnosis remained unchanged in 62 of 229 subjects who received a florbetapir scan.||Percent Change in Confidence||Standard Deviation|Mean
694542|NCT01400425|Other Pre-specified|Item Wise Changes in Physician Management Plan|This outcome analyzed the percentage of subjects who had a hypothetical change in one of the medication or diagnostic categories listed below after receiving a florbetapir scan.|6 weeks|The number of subjects analyzed for each reporting group is determined by scan status. There were 229 total subjects with progressive cognitive decline of whom 113 received a positive florbetapir scan and 116 received a negative florbetapir scan.||Percentage of subjects|||Number
694543|NCT01400425|Secondary|Percentage of Subjects Who Undergo a Hypothetical Change in Clinical Diagnosis and Physician Management Plan After Obtaining a Positive Florbetapir F 18 PET Scan|The impact of a positive florbetapir F 18 PET scan on a physician's clinical diagnosis and management of a subject was evaluated on a hypothetical basis because at the start of this study Florbetapir F 18 was an investigational drug and the data collected is for research purposes only. The percentage of subjects who received a positive florbetapir scan that led to a change in hypothetical clinical diagnosis and physician management plans are presented below. A positive florbetapir PET scan is indicative of moderate to frequent β-amyloid neuritic plaque density according to the modified Consortium to Establish a Registry for Alzheimer's Disease (CERAD) criteria.|6 weeks|113 out of 229 subjects with progressive cognitive decline received a positive florbetapir scan.||Percentage of subjects||95% Confidence Interval|Number
694544|NCT01400425|Primary|Percentage of Subjects Who Undergo a Hypothetical Change in Clinical Diagnosis and Physician Management Plan After Obtaining a Negative Florbetapir F 18 PET Scan.|The impact of a negative florbetapir F 18 PET scan on a physician's clinical diagnosis and management of a subject was evaluated on a hypothetical basis because at the start of this study Florbetapir F 18 was an investigational drug and the data collected is for research purposes only. The percentage of subjects who received a negative florbetapir scan that led to a change in hypothetical clinical diagnosis and physician management plans are presented below. A negative florbetapir PET scan is indicative of none to sparse β-amyloid neuritic plaque density according to the modified Consortium to Establish a Registry for Alzheimer's Disease (CERAD) criteria.|6 weeks|116 of 229 subjects with progressive cognitive decline received a negative florbetapir scan.||Percentage of subjects||95% Confidence Interval|Number
694545|NCT01400412|Secondary|Number of Participants Who Developed Grade 3 or 4 Primary Adverse Events|"Grade 3 or 4 primary adverse events includes primary signs/symptoms, primary laboratory abnormalities, or primary diagnoses.
See DAIDS AE Grading Table Version 1.0, Dec 2004 (Clarification, Aug 2009)"|From study treatment initiation to week 48|All participants who initiated study treatment||participants|||Number
694546|NCT01400412|Secondary|Number of Participants Who Died During the Study||From study treatment initiation to week 48|All participants who started study treatment||participants|||Number
694547|NCT01400412|Secondary|Number of Participants Who Experienced Bone Fractures|Number of participants who experienced bone fractures during the study|From study treatment initiation to week 48|All participants who started study treatment||participants|||Number
694548|NCT01400412|Secondary|Cumulative Probability of Virologic Failure by Week 48|"Confirmed virologic failure is defined as confirmed plasma HIV-1 RNA levels > 1000 copies/mL at or after week 16 and before week 24, or confirmed HIV-1 RNA levels> 200 copies/mL at or after week 24. Participants who discontinued the study with an unconfirmed virologic failure (HIV-1 RNA > 1000 copies at 16 weeks or HIV-1 RNA level > 200 copies/mL at or after week 24) are considered as virologic failures at the study visit week of the unconfirmed value. Time to virologic failure is defined as the time from study entry to the planned visit week of the initial failure.
Product-limit estimates for the survival function were used to estimate the cumulative probability of virologic failure over time and its corresponding 95% confidence interval for each treatment group."|From study treatment initiation to week 48|All participants who started study treatment||cumulative probability per 100 persons||95% Confidence Interval|Number
694549|NCT01400412|Secondary|Change in Levels of D-dimer From Baseline||At weeks 0 and 48|As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks.||ng/ml||Inter-Quartile Range|Median
694550|NCT01400412|Secondary|Change in Levels of sCD14 From Baseline|Change in levels of soluble CD14 from baseline|At weeks 0 and 48|As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks.||pg/ml||Inter-Quartile Range|Median
694551|NCT01400412|Secondary|Change in Levels of sCD163 From Baseline to Week 48|Change in levels of soluble CD163 from baseline to week 48|At weeks 0 and 48|As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks.||ng/ml||Inter-Quartile Range|Median
694552|NCT01400412|Secondary|Change in Level of IP-10 From Baseline to Week 48|Change in level of Interferon gamma-induced protein 10 (IP-10) from baseline to week 48|At weeks 0 and 48|As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks.||pg/ml||Inter-Quartile Range|Median
694553|NCT01400412|Secondary|Change in Levels of IL-6 From Baseline to Week 48|Change in levels of Interleukin 6 (IL-6) from baseline to week 48|At weeks 0 and 48|As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks.||pg/ml||Inter-Quartile Range|Median
694554|NCT01400412|Secondary|Percent Change in Expression of RANKL+ on CD8+ T Cells From Baseline to Week 48|percentage change is defined as [ (week 48 - week 0) / week 0 ] * 100%|At weeks 0 and 48|As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks.||percentage change||Inter-Quartile Range|Median
694555|NCT01400412|Secondary|Percent Change in Expression of CD28+ on CD8+ T Cells From Baseline to Week 48|percentage change is define as [ (week 48 - week 0) / week 0 ] * 100%|At weeks 0 and 48|As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks.||percentage change||Inter-Quartile Range|Median
694556|NCT01400412|Secondary|Percent Change in Expression of CD57+ on CD8+ T Cells From Baseline to Week 48|percentage change is define as [ (week 48 - week 0) / week 0 ] * 100%|At weeks 0 and 48|As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks.||percentage change||Inter-Quartile Range|Median
694557|NCT01400412|Secondary|Percent Change in Expression of CD28+/CD57+ on CD8+ T Cells From Baseline to Week 48|percentage change is define as [ (week 48 - week 0) / week 0 ] * 100%|At weeks 0 and 48|As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks.||percentage change||Inter-Quartile Range|Median
694558|NCT01400412|Secondary|Percentage Change in Expression of CD38+/HLA-DR+ on CD8+ T Cells From Baseline to Week 48|percentage change is defined as [ (week 48 - week 0) / week 0 ] * 100%|At weeks 0 and 48|As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks.||percentage change||Inter-Quartile Range|Median
694563|NCT01400412|Secondary|Percent Change in Lumbar Spine Bone Mineral Density (BMD)|The percent change in bone mineral density (BMD) at lumbar spine (as measured by DXA scan) from baseline (week 0) to week 48.|Week 0, week 48|As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks.||percentage change||Inter-Quartile Range|Median
694564|NCT01400412|Primary|Percent Change From Baseline in Total Hip Bone Mineral Density (BMD)|The primary endpoint is the percent change in bone mineral density (BMD) at total hip (as measured by DXA scan) from baseline (week 0) to week 48.|Week 0, week 48|The primary analysis was as-treated which included only participants with total hip BMD measurements available at both week 0 and week 48 who remained on their randomized MVC or TDF component by the time week 48 measurement was taken without an interruption of treatment of more than 10 weeks.||percentage change||Inter-Quartile Range|Median
694565|NCT01400243|Primary|POMS Vigor/Positive Affect (PA)|"Profile of Mood State questionnaire Vigor/Positive Affect scale. The potential range of the Vigor/Positive Affect scale is from 0 (no vigor) to 32 (maximally high vigor score)."|16 days (baseline through day 15 of treatment)|||units on a scale||Standard Error|Mean
694566|NCT01400243|Primary|Marijuana Withdrawal Questionnaire (MWC) Total Score|"The Marijuana Withdrawal Questionnaire Total Score includes items assessing anxiety, depression, irritability, appetite, aggression/anger, sleep disturbance, somatic disturbances, and craving to use marijuana. The potential range of this total score is from 0 = no withdrawal symptoms to 47 = maximally high levels of withdrawal."|16 days (prequit baseline and at 1, 3, 5, 7, 9, 11, 13, and 15 days of abstinence)|||units on a scale||Standard Error|Mean
694567|NCT01400243|Secondary|Diastolic Blood Pressure (DBP)|Diastolic blood pressure measured during each of the experimental sessions-- baseline through 15-days post-quit.|From baseline to Day 15 of abstinence|||mm Hg||Standard Error|Mean
694568|NCT01400243|Secondary|Heart Rate|Heart rate measured during laboratory assessment sessions.|Baseline through Day 15 of abstinence|||beats per minute||Standard Error|Mean
694569|NCT01400243|Secondary|Urinary Tetrahydrocannabinol (THC) Concentration in ng/ml.|Tetrahydrocannabinol (THC) Intake assessed by assessing urine sample creatinine corrected THC in ng/ml urine.|across baseline and at 3, 5, 7, 9, 11, 13, and 15 days of abstinence|||ng/ml urine creatinine-corrected THC||Standard Error|Mean
694570|NCT01400243|Secondary|Tobacco and Nicotine Intake|Nicotine intake was assessed by self-reported tobacco cigarettes per month (30 days) at baseline (prior to treatment) and also across the 30 days starting immediately after the end of treatment.|Basesline 30 days prior to study and during the 30 days following the 15-day abstinence phase.|||Cigarettes per 30 days||Standard Error|Mean
694571|NCT01400243|Secondary|Systolic Blood Pressure (SBP)|Systolic blood pressure was measured in mmHg during each experimental session prior and subsequent to quitting marijuana.|From baseline to Day 15 of abstinence|||mmHg||Standard Error|Mean
694572|NCT01400243|Secondary|Patch Guess and Attributions Questionnaire|The Patch Guess and Attributions Questionnaire assesses which type of patch (active versus placebo) the subject believes that he or she was given during the study. This assessment was made at end of treatment (Day 15 of abstinence), the last day on a patch. Scores range from 0 percent to 100 percent chance of being on the nicotine patch for those actually on the placebo patch and from 0 percent to 100 percent chance of being on the nicotine patch for those subjects actually on the nicotine patch. Each subject was asked to indicate the percentage chance that he or she was on the nicotine (as opposed to the placebo) patch. The mean values reported below are the group mean percentage averages.|Day 15 of abstinence|||Percentage chance on nicotine patch||Standard Error|Mean
694573|NCT01400243|Primary|Profile of Mood Scale Total Negative Affect (Tension + Depression + Anger)|"POMS Total negative affect was assessed during the final pre-quit baseline session and the 8 post-quit sessions (1, 3, 5, 7, 9, 11, 13, and 15 days post-quit). The Total negative affect score has a minimum potential value of 0 = best possibly level and a maximum value of 154 = worst possible level."|16 days (prequit baseline and 15 days of abstinence)|||units on a scale||Standard Error|Mean
694621|NCT01399619|Secondary|Early Treatment Success (ETS)|Early Treatment Success (ETS): Plasma HCV RNA level<25 IU/mL (detected or undetected) at Week 4 and HCV RNA< 25 IU/mL, undetected at Week 8|Week 4, week 8 and week 60|FAS||participants|||Number
699998|NCT00033371|Secondary|Global Duodenal Polyp Burden|The two-sample t-test or its non-parametric analogue, the Wilcoxon rank sums test will be used.|Up to 2 months after completion of study treatment||||||
694583|NCT01400113|Secondary|Clinical Global Impression Scale|Secondary outcome measures will include the Clinical Global Impression -Severity (CGI-S) and Clinical Global Impression-Improvement (CGI-I) scales.|2 hours||||||
694584|NCT01400113|Primary|Positive and Negative Syndrome Scale - Excited Component|The primary outcome measure is change in the Positive and Negative Syndrome Scale - Excited Component (PANSS-EC) from baseline to 2 hours after medication administration. The PANSS-EC consists of 5 items: excitement, tension, hostility, uncooperativeness, and poor impulse control. The 5 items from the PANSS-EC are rated from 1 (not present) to 7 (extremely severe); scores range from 5 to 35; mean scores ≥ 20 clinically correspond to severe agitation. This set of items detects differences between drug and placebo when evaluating acute agitation and aggression in psychiatric patients with different psychiatric pathologies.|Change in PANSS-EC score from baseline to 2 hours post drug/placebo administration.|||PANSS SCORE||95% Confidence Interval|Mean
694585|NCT01399866|Secondary|Effect of D-cycloserine + Cue-exposure Treatment on Attentional Bias Toward Smoking Cues|Recently abstinent smokers assigned to receive D-cycloserine + CET will have less attentional bias (Smoking Stroop task) toward smoking cues at the Post-Extinction Assessment than those who receive placebo + CET|Up to 6 weeks||||||
694586|NCT01399866|Secondary|Effect of D-cycloserine + Cue-exposure Treatment on Craving|Recently abstinent smokers assigned to receive D-cycloserine + CET will have less craving at the Post-Extinction Assessment than those who receive placebo + CET|Up to 6 weeks||||||
694587|NCT01399866|Secondary|Effect of D-cycloserine + Cue-exposure Treatment on Electromyogram|Recently abstinent smokers assigned to receive D-cycloserine + CET will have less physiologic (electromyogram) reactivity to smoking cues at the Post-Extinction Assessment than those who receive placebo + CET.|Up to 6 weeks||||||
694588|NCT01399866|Secondary|Effect of D-cycloserine + Cue-exposure Treatment on Heart Rate|Recently abstinent smokers assigned to receive D-cycloserine + CET will have less physiologic (heart rate) reactivity to smoking cues at the Post-Extinction Assessment than those who receive placebo + CET.|Up to 6 weeks||||||
694589|NCT01399866|Secondary|Effect of D-cycloserine + Cue-exposure Treatment on Skin Conductance|Recently abstinent smokers assigned to receive D-cycloserine + CET will have less physiologic (skin conductance) reactivity to smoking cues at the Post-Extinction Assessment than those who receive placebo + CET.|Up to 6 weeks||||||
694590|NCT01399866|Primary|Effect of D-cycloserine + Cue-exposure Treatment on Continuous Abstinence From Tobacco Smoking.|Participants assigned to receive D-cycloserine + CET will achieve better maintenance of tobacco abstinence, as assessed with self-report and saliva cotinine measurements, than those who receive placebo + CET at week 6 follow up visits|Up to 6 weeks|||percentage of participants|||Number
694591|NCT01399788|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 hrs post-dose for rifampicin, isoniazid and ethambutol and additional 36 and 48 hrs post-dose for pyrazinamide|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters for one of four analytes in at least 1 treatment period.||hr||Full Range|Median
694965|NCT01396044|Primary|Empiric Antibiotic Duration||During intensive care unit admission, an average of 5 days per patient (although individual patients may vary)|All patients who received at least one day of empirical antibiotics during their ICU admission.||days||Inter-Quartile Range|Median
694592|NCT01399788|Secondary|Plasma Decay Half-life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 hrs post-dose for rifampicin, isoniazid and ethambutol and additional 36 and 48 hrs post-dose for pyrazinamide|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters for one of four analytes in at least 1 treatment period. Here, 'n' is number of participants who were evaluable for this measure.||hr||Standard Deviation|Mean
694593|NCT01399788|Secondary|Dose Normalized Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0-∞][dn]) for Pyrazinamide|AUC [0-∞][dn] = Dose normalized area under the plasma concentration versus time curve (AUC[dn]) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-∞) divided by dose and then multiplied by 1500. The test and reference for pyrazinamide were given at different doses, so dose-normalized parameters were used for analysis for adjusting the dose effect on bioequivalence conclusion.|0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hrs post-dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters for one of four analytes in at least 1 treatment period.||(ng*hr/mL)/mg||Standard Deviation|Geometric Mean
694594|NCT01399788|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC[0-∞])|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 hrs post-dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters for one of four analytes in at least 1 treatment period. Here, 'n' is number of participants who were evaluable for this measure.||ng*hr/mL||Standard Deviation|Geometric Mean
694595|NCT01399788|Primary|Dose Normalized Maximum Observed Plasma Concentration (Cmax[dn]) for Pyrazinamide|It is obtained from Cmax divided by dose and then multiplied by 1500. The test and reference for pyrazinamide were given at different doses, so dose-normalized parameters were used for analysis for adjusting the dose effect on bioequivalence conclusion.|0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hrs post-dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters for one of four analytes in at least 1 treatment period.||(ng/mL)/mg||Standard Deviation|Geometric Mean
694596|NCT01399788|Primary|Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast[dn]) for Pyrazinamide|AUClast[dn] = Dose normalized area under the plasma concentration-time curve (AUC[dn]) from time zero (pre-dose) to the time of last measured concentration. It is obtained from AUClast divided by dose and then multiplied by 1500. The test and reference for pyrazinamide were given at different doses, so dose-normalized parameters were used for analysis for adjusting the dose effect on bioequivalence conclusion.|0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hrs post-dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters for one of four analytes in at least 1 treatment period.||(ng*hr/mL)/mg||Standard Deviation|Geometric Mean
694597|NCT01399788|Primary|Maximum Observed Plasma Concentration (Cmax)||0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 hrs post-dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters for one of four analytes in at least 1 treatment period.||ng/mL||Standard Deviation|Geometric Mean
694598|NCT01399788|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration-time curve from time zero (pre-dose) to the time of last measured concentration (AUClast).|0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 hours (hrs) post-dose|Pharmacokinetic (PK) parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters for one of four analytes in at least 1 treatment period.||ng*hr/mL||Standard Deviation|Geometric Mean
694599|NCT01399723|Secondary|Outcome (Death/Readmission) at 14 Days as Determined by Telephone or Direct Interview|Definition of death as described in third secondary outcome measure.|Day 14|||participants|||Number
694600|NCT01399723|Secondary|Death at or Before Five Days Following Enrollment|Death defined as: in-hospital death occurring at any time after randomisation (recruitment for HIV-exposed participants) or verbal report of death of the enrolled patient from parent/guardian communicated either directly or via telephone conversation.|Day 0 to Day 5||||||
694601|NCT01399723|Secondary|Readmission With Diagnosis of Severe or Very Severe Pneumonia Within 14 Days of Enrollment||Day 0 to Day 14||||||
694602|NCT01399723|Secondary|Treatment Failure at or Before Discharge / Day 5 Post Enrollment (Whichever Occurs First)|Treatment failure as defined in the primary outcome measure.|Patients will be followed up from the day of hospitalisation (day 0) until the day of medical discharge (average duration of 3 days) or until day 5 of hospitalisation (whichever occurs first).|Intention to treat analysis||participants|||Number
694603|NCT01399723|Primary|Treatment Failure at 48 Hours (Two Full Days After Enrollment)|Development of any signs of very severe pneumonia at any time Hypoxemia defined as SpO2 <85% or <80% for altitude < or ≥1500m respectively measured after minimum of 3 minutes on ambient air Persistent vomiting (occurring within 30 minutes of administration of amoxicillin with failure to retain drug after 3 successive attempts at administration) at any time Clinical diagnosis of new bacterial co-morbid condition requiring revision of antibiotic treatment at any time Lower chest wall indrawing Temperature ≥38◦C Respiratory rate ≥5bpm of admission rate if above age-adjusted normal upper limit|48 hours|Intention to treat analysis||participants|||Number
694604|NCT01399697|Secondary|Change From Week 16 to Week 28 in Global Assessment of Disease Activity Assessed Using the VAS Performed by the Investigator|Participants were asked to rate their global assessment of disease activity on a scale ranging from 0=very good to 100=very bad. The scale was represented by a line with 0 at the left edge and 100 at the right edge. The participant was asked to mark the line corresponding to the assessment of their disease activity. The distance from the left edge was measured in mm.|Week 16 and Week 28|ITT Population; only participants with non missing values were included in the analysis.||units on a scale||Standard Deviation|Mean
694622|NCT01399619|Secondary|Virological Response 24 Weeks Post Treatment (SVR24)|Percentage of participants with virological response 24 weeks post treatment (SVR24): Plasma HCV RNA level<25IU/mL (undetected) 24 weeks after the planned end of treatment.|72 weeks|FAS||percentage of participants||95% Confidence Interval|Number
694605|NCT01399697|Secondary|Change From Week 16 to Week 28 in Global Assessment of Disease Activity as Assessed With the Visual Analogue Scale (VAS) Performed by Participant|Participants were asked to rate their global assessment of disease activity on a scale ranging from 0=very good to 100=very bad. The scale was represented by a line with 0 at the left edge and 100 at the right edge. The participant was asked to mark the line corresponding to the assessment of their disease activity. The distance from the left edge was measured in mm.|Week 16 and Week 28|ITT Population; only participants with non missing values were included in the analysis.||units on a scale||Standard Deviation|Mean
694606|NCT01399697|Secondary|Change in the Quality of Life Questionnaire (SF-12) From Week 16 to Week 28 in Physical Health|Quality of life questionnaire (SF-12) scores were computed using the scores of 12 questions and ranged from 0 to 100, where a 0 score indicated the lowest level of health measured by the scales and 100 indicated the highest level of health. A negative change from baseline indicated a worsening of quality of life.|Week 16 and Week 28|ITT Population; only participants with non missing data were included in the analysis.||units on a scale||Standard Deviation|Mean
694607|NCT01399697|Secondary|Change in the Quality of Life Questionnaire (Short Form-12 [SF-12]) From Week 16 to Week 28 in Mental Health|Quality of life questionnaire (SF-12) scores were computed using the scores of 12 questions and ranged from 0 to 100, where a 0 score indicated the lowest level of health measured by the scales and 100 indicated the highest level of health. A negative change from baseline indicated decline in health and higher scores indicated improvement in health.|Week 16 and Week 28|ITT Population; only participants with non missing values were included in the analysis.||units on a scale||Standard Deviation|Mean
694608|NCT01399697|Secondary|Change in the Health Assessment Questionnaire Disability Index (HAQ-DI) From Week 16 to Week 28|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0 = no difficulty; 1 = some difficulty; 2 = much difficulty; 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Week 16 and Week 28|ITT Population; only participants with non missing values were included in the analysis.||units on a scale||Standard Deviation|Mean
694609|NCT01399697|Secondary|Percentage of Participants With Simplified Disease Activity Index (SDAI) <3.3 at Week 28|SDAI is calculated by a simple numerical sum of tender and swollen joint count (based on a 28-joint assessment), participant and physician global assessment of disease activity (VAS 0-10 cm), and level of C-reactive protein in milligram per deciliter (mg/dL). SDAI total score 0-86; higher scores = greater affect due to disease activity. SDAI <3.3 = clinical remission.|28 weeks|ITT Population; only participants with SDAI scores at Week 28 were included in the analysis.||percentage of participants|||Number
694610|NCT01399697|Secondary|Percentage of Participants With Clinical Disease Activity Index (CDAI) <2.8 at Week 28|CDAI is the sum of tender and swollen joint count based on 28 joints and the participant and physician global disease assessment (VAS 0-10 centimeters [cm]). CDAI total score 0-76; higher scores = greater affect due to disease activity. CDAI <2.8 = clinical remission.|Week 28|ITT Population; only participants with CDAI scores at Weeks 28 were included in the analysis.||percentage of participants|||Number
694611|NCT01399697|Secondary|Percentage of Participants With DAS28 Score Less Than (<) 2.6 at Week 28|The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores indicate worsening. DAS28 <2.6 equals (=) remission.|Week 28|ITT Population; only participants with Week 28 DAS28 values were included in the analysis.||percentage of participants|||Number
694612|NCT01399697|Primary|Change in Disease Activity Score Based on 28-Joint Count (DAS28) From Week 16 to Week 28|The DAS28 is a combined index for measuring disease activity in rheumatoid arthritis (RA). The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (erythrocyte sedimentation rate [ESR] in millimeters per hour [mm/hr]), and general health status (participant global assessment of disease activity using visual analog scale [VAS], range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.|Baseline, Week 16, and Week 28|Intent-to-treat (ITT) population: all randomized participants who received at least one dose of study medication and who had at least one efficacy measurement performed.||units on a scale||Standard Deviation|Mean
694613|NCT01399619|Secondary|The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=no|The number of participants with AST in normal range at Post Treatment (SVR12 Visit) when SVR12=no. BL = baseline.|60 weeks|FAS||participants|||Number
694614|NCT01399619|Secondary|The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=Yes|The number of participants with AST in normal range at Post Treatment (SVR12 Visit) when SVR12=yes. BL = baseline.|60 weeks|FAS||participants|||Number
694615|NCT01399619|Secondary|The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=no|The number of participants with Aspartate Aminotransferase (AST) normalisation at End of Treatment when SVR12=no. BL = baseline.|48 weeks|FAS||participants|||Number
694616|NCT01399619|Secondary|The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=Yes|The number of participants with Aspartate Aminotransferase (AST) normalisation at End of Treatment when SVR12=yes. BL = baseline.|48 weeks|FAS||participants|||Number
694617|NCT01399619|Secondary|The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=no|The number of participants with ALT in normal range at post treatment (SVR12 Visit) when SVR12=no. BL = baseline.|60 weeks|FAS||participants|||Number
694618|NCT01399619|Secondary|The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=Yes|The number of participants with ALT in normal range at post treatment (SVR12 Visit) when SVR12=yes. BL = baseline.|60 weeks|FAS||participants|||Number
694619|NCT01399619|Secondary|The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment When SVR12=no|The number of participants with Alanine Aminotransferase (ALT) normalisation: ALT in normal range at End of Treatment when SVR12=no. BL stands for baseline.|48 weeks|FAS||participants|||Number
694623|NCT01399619|Primary|Sustained Virological Response (SVR12)|Percentage of participants with sustained Virological Response SVR12: Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) level <25 IU/mL, undetected 12 weeks after the planned end of treatment.|60 weeks|FAS||percentage of participants||95% Confidence Interval|Number
694624|NCT01399593|Primary|Treatment Failure Rate|The primary efficacy variable was a binary outcome variable where patients meeting the composite endpoint of the occurrence of 1) biopsy-proven acute AMR, 2) graft loss, 3) patient death, or 4) loss to follow-up definition at Week 9 post-transplantation were considered treatment failures and all others were considered treatment successes.|9 weeks post-transplantation|Full analysis set, defined as patients who were randomized, received a living donor kidney transplant, and were treated (either with eculizumab or SOC), based on randomized treatment groups.||Participants|||Count of Participants
694625|NCT01399268|Secondary|Ability to Ambulate||48 hours|||Participants|||Count of Participants
694626|NCT01399268|Secondary|Mortality||Length of hospital stay, an expected average of 5 days|||Participants|||Count of Participants
694627|NCT01399268|Secondary|In Hospital Infection Rate||Length of hospital stay, an expected average of 5 days|||Participants|||Count of Participants
694628|NCT01399268|Secondary|Length of Hospital Stay||Length of hospital stay, an expected average of 5 days|||days||Standard Deviation|Mean
694629|NCT01399268|Secondary|Blood Glucose||24 hours postoperative|||mg/dL||Standard Deviation|Mean
694630|NCT01399268|Secondary|Desmosine Level||24 hours postoperative|Data were not collected|||||
694631|NCT01399268|Primary|Decrease in IL6 Level||24 hours postoperative|||pg/ml||99% Confidence Interval|Mean
694632|NCT01399229|Primary|Comparison of SureCALL® and Tocodynamometer Detection of Contraction Event Timing|Time Stamps of the Peaks of Corresponding Contractions|9 - 41 Minutes|||Seconds||Standard Deviation|Mean
694633|NCT01399190|Secondary|Percentage of Participants With Adverse Events|An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Up to approximately 30 months|Includes enrolled participants eligible for inclusion in the final analysis.||percentage of participants|||Number
694634|NCT01399190|Secondary|Response Rate (Tumor Assessments According to RECIST)|Response to treatment (Response Rate) was defined as the percentage of participants with a complete remission (CR) or partial remission (PR), and was assessed by the investigators according to modified RECIST criteria. CR was defined as disappearance of all lesions. PR was defined as a decrease in sum of lesions size by more than 30%. Response Rate = CR +PR|Up to approximately 30 months|Includes enrolled participants who were evaluable for the primary endpoint analysis.||percentage of participants|||Number
694635|NCT01399190|Primary|Progression-free Survival|Progression-free survival was defined as the interval between the day of first treatment and the first documentation of disease progression or death and was assessed by the investigators according to modified Response Evaluation Criteria in Solid Tumors (RECIST). Disease progression was defined as an increase in sum of lesions size by more than 20% or new lesions.|From randomization to progression or death during the study (up to approximately 30 months)|Includes enrolled participants who were evaluable for the primary endpoint analysis.||months||95% Confidence Interval|Median
694636|NCT01399125|Secondary|Change From Baseline in Mini-Mental State Examination (MMSE) Total Score|The Mini-Mental State Examination (MMSE) was used to establish patient’s eligibility for the study and it was also used as an efficacy parameter in the Double-blind Treatment Period. The MMSE is a brief, practical screening test for cognitive dysfunction. The test consists of five sections (orientation, registration, attention-calculation, recall, and language) and results in a total possible score of 30, with higher scores indicating betterfunction. The total MMSE score at screening was between 10 and 20, inclusive, in order forthe patient to be eligible to participate in the trial.|Change at 24 weeks|Per Protocol (PP): patients who received at least one dose of study drug, had a baseline assessment and at least one post-baseline assessment on treatment (after Day 140 and not more than 2 days after the last known date of study drug) of the primary efficacy variable and have no major protocol deviations.||scores on a scale||Standard Deviation|Mean
694637|NCT01399125|Secondary|Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score|NPI including Caregiver Distress Scale (NPI-D) assesses a wide range of behavior problems encountered in dementia patients to provide a means of distinguishing frequency and severity of changes in behavioral problems & facilitates rapid behavioral assessment using screening questions.10 behavioral problems & 2 neurovegetative domains were evaluated through an interview of the caregiver by a mental health professional. The scale includes both frequency & severity ratings of ea. domain as well as a composite domain score(frequency x severity). Frequency: 1(occasionally) - 4(very frequently)&severity:1(mild) - 3(marked).The sum of the composite scores of the 12 domains yields the NPI total score. The NPI-D: 0(not severe & not at all distressing) - 5 (very severe or extremely distressing) for each of the 12 domains. NPI-12 total score: from 0-144, the NPI-10 total score: from 0-120, & NPI-D score: from 0-60, all with higher scores indicating more severe behavioral disturbance.|Change at 24 weeks|Per Protocol (PP): patients who received at least one dose of study drug, had a baseline assessment and at least one post-baseline assessment on treatment (after Day 140 and not more than 2 days after the last known date of study drug) of the primary efficacy variable and have no major protocol deviations.||scores on a scale||Standard Deviation|Mean
694654|NCT01398982|Secondary|Sedation Level|Sedation score in-patient|In Hospital postoperative measures, average 4-5 days||||||
694655|NCT01398982|Secondary|Postoperative Nausea and Vomiting|Postoperative nausea and vomiting (score of 0-3)|In Hospital postoperative measures, average 4-5 days||||||
694656|NCT01398982|Secondary|Duration of Hospital Stay|Duration of hospital stay (# of days)|In-patient hospital stay, average of 4-5 days||||||
694657|NCT01398982|Secondary|Quality of Recovery|Quality of Recovery (QOR) score (0-18)|In-patient hospital stay, first post operative 48 hours||||||
694658|NCT01398982|Secondary|Anti-nausea Consumption|Total in-hospital cumulative anti-nausea consumption|In-patient hospital stay, average 4-5 days||||||
694659|NCT01398982|Secondary|First Bowel Movement|Time to first bowel movement (# of days)|In-patient hospital stay, average 4-5 days||||||
694660|NCT01398982|Secondary|Pain Disability|Pain Disability Index Scores|Hospital discharge, average 4-5 days, 6 months and 1 year following discharge||||||
694638|NCT01399125|Secondary|Change From Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Total Score|"Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) is a caregiver-based Activities of Daily Living (ADL) scale composed of 23 items developed for use in dementia clinical studies. It was designed to assess the patient’s performance of both basic and instrumental activities of daily living such as those necessary for personal care, communicating and interacting with other people, maintaining a household, conducting hobbies and interests, as well as making judgments and decisions. Responses for each item were obtained from the caregiver through an interview. For each basic ADL, there was a forced choice of best response or a yes or no question with additional sub questions. Higher numbered scores and answers of yes reflected a more self-sufficient individual. Therefore, the higher total score, the higher functioning the patient was. The total score was the sum of all items and sub questions. The range for the total ADCS-ADL score was 0 to 78."|Change at 24 weeks|Per Protocol (PP): patients who received at least one dose of study drug, had a baseline assessment and at least one post-baseline assessment on treatment (after Day 140 and not more than 2 days after the last known date of study drug) of the primary efficacy variable and have no major protocol deviations.||scores on a scale||Standard Deviation|Mean
694639|NCT01399125|Secondary|Change From Baseline in Global Functioning, Assessed by the Alzheimer's Disease Assessment Scale Clinical Impression of Change (ADCS-CGIC)|Alzheimer’s disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) scale provides a single global rating of change from baseline. It was recommended that the baseline interview be conducted by two raters, one designated as the primary rater, the other as a backup. Both raters were independent trained clinicians, experienced in the assessment of patients with dementia. Neither rater was involved in any other way with the patients’ treatment or evaluation throughout the study. At baseline, both raters had access to all of the patient’s available records and evaluations. Subsequently, for all ratings of change from baseline, the rater relied solely on information obtained during the baseline interview of the patient and caregiver, including written notes and, if available, the baseline interview audio- or videotape. The rater had no access to any other safety or efficacy data, including all previous post-baseline ADCS-CGIC ratings by either rater.|Change at 24 weeks|Per Protocol (PP): patients who received at least one dose of study drug, had a baseline assessment and at least one post-baseline assessment on treatment (after Day 140 and not more than 2 days after the last known date of study drug) of the primary efficacy variable and have no major protocol deviations.||participants|||Number
694640|NCT01399125|Primary|Change From Baseline on Cognition, Assessed by the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog)|The Alzheimer’s Disease Assessment Scale (ADAS) is a performance-based test that measures specific cognitive and behavioral dysfunctions in patients with Alzheimer's Disease. The cognitive subscale of the ADAS (ADAS-Cog) comprises 11 items that are summed to a total score ranging from 0 to 70, with lower scores indicating less severe impairment. It was assessed by a mental health professional (e.g., M.D., Ph.D., Pharm.D., R.N., or other equivalent qualifications) with a minimum of 2 years research experience meeting certification requirements.|Change at 24 weeks|Per Protocol (PP): patients who received at least one dose of study drug, had a baseline assessment and at least one post-baseline assessment on treatment (after Day 140 and not more than 2 days after the last known date of study drug) of the primary efficacy variable and have no major protocol deviations.||Scores on a scale||Standard Deviation|Mean
694641|NCT01399099|Secondary|Comparison of Scar Smoothness of Treated Side as Compared to the Control Side||Up to 12 months||||||
694642|NCT01399099|Secondary|Comfort Level Related to Study Device Application, Wear and Removal||Up to 12 weeks||||||
694643|NCT01399099|Secondary|Ease of Use||Up to 12 months||||||
694644|NCT01399099|Secondary|Subject and Investigator Satisfaction With the Aesthetic Results||Up to 12 months||||||
694645|NCT01399099|Primary|Visual Analogue Scale (VAS)|"Visual Analogue Scale Scar Score (VAS Scar Score) was defined and validated by Duncan et al 2006[1]. This scale consists of a 10cm line representing scar quality, with 0 representing normal skin and 10 indicating a poor scar. The assessor places a mark along the line to represent the appearance of the scar. This mark is translated into a score by measuring its position on the 10cm line to one decimal place. The independent panel used this to scale the primary outcome.
[1] Duncan J, Bond J, Mason T, Ludlow A, Cridland P, O'Kane S and Ferguson M. Visual Analogue Scale Scoring and Ranking: A Suitable and Sensitive Method for Assessing Scar Quality? Plast. Reconstr. Surg. 118: 909, 2006."|12 months|Per protocol, all eligible patients who did not exit the study prematurely.||Units on a scale||Standard Error|Mean
694646|NCT01399047|Secondary|Feasibility of Clinical Trials in Rare Disorder|To pilot the feasibility of conducting controlled clinical trials of this rare neurological disorder base on collaboration between a national center of excellence in the disease (URBC), and children's local care-providers (pediatricians and/or local neurologists.|||||||
694647|NCT01399047|Secondary|Preliminary Evidence of Efficacy|To gather preliminary evidence of the short-term (8 week) impact of mycophenolate mofetil on clinically relevant features of Juvenile Neuronal Ceroid Lipofuscinosis as measured by the Unified Batten Disease Rating Scale, including motor features, seizures, behavior, cognitive and functional measures.|8 week||||||
694648|NCT01399047|Primary|Tolerability|The primary outcome measure is tolerability, defined as the completion of 8 weeks on the assigned dosage of study drug.|8 weeks|||Participants|||Count of Participants
694649|NCT01399008|Primary|Serum Uric Acid|Percent change from baseline in serum uric acid in Per Protocol population|Percent change from baseline in serum uric acid at Week 4|Per Protocol population (all randomized patients who received at least 1 dose of blinded study drug, had at least 1 post-treatment evaluation, had not violated any major entry criterion likely to confound an efficacy analysis and had not deviated significantly from the protocol between enrollment and study completion).||percent change||Standard Deviation|Mean
694650|NCT01398982|Secondary|Time to Ambulation|Time to ambulation (# of days)|In-patient hospital stay, average 4-5 days||||||
694651|NCT01398982|Secondary|Health Related Quality of Life|Short-form health-related quality of life 36 Scores|Hospital discharge, average 4-5 days, 6 months and 1 year following discharge||||||
694652|NCT01398982|Secondary|Anxiety and Depression|Hospital Anxiety and Depression Scale Score|Hospital discharge, average 4-5 days, 6 months and 1 year following discharge||||||
694653|NCT01398982|Secondary|Pain Frequency and Intensity|Short-form McGill Pain Questionnaire Score|Hospital discharge, average 4-5 days, 6 months and 1 year following discharge||||||
694663|NCT01398982|Primary|Mean Total Opioid Consumption|The primary objective of this study is to compare the mean total opioid consumption in the first postoperative 48 hours between the control and study groups in intravenous morphine equivalent units. By directly blocking the neural afferents, the mean opioid consumption will be significantly lower in the group receiving intermittent local anaesthetic boluses compared to the placebo group through a TAP catheter.|first postoperative 48 hours|||mg||Standard Deviation|Mean
694664|NCT01398956|Secondary|The Incidence of Adverse Drug Reactions During the Entire Study Period|Adverse drug reactions excludes Adverse Events (AEs) described by the investigators with no relationship to study drug.|Through study completion, an average of 3 years|The Safety Set (SS) consisted of all subjects who took at least one dose of study medication in this study.||Adverse Drug Reactions|||Number
694665|NCT01398956|Secondary|The Percentage Change in Generalized Tonic-Clonic (GTC) Seizure Frequency Per Week Over the Evaluation Period From Either of the Combined Baseline Periods of the Previous Studies (N01159 or N01363).|"Percentage change in generalized tonic-clonic (GTC) seizure frequency per week from Baseline of previous studies B over the Treatment Period A is calculated using the equation:
Percentage change from Baseline = ((A-B)/B)*100. Percentage change from baseline is not defined for subjects whose baseline information is missing / unknown or equal to zero, or whose seizure frequency per week is missing/unknown. A negative value in change in generalized tonic-clonic (GTC) seizure frequency indicates a reduction of generalized tonic-clonic (GTC) seizure frequency over the Treatment Period."|During the Treatment Period (up to 4.8 years)|The Full Analysis Set (FAS) consisted of all subjects with evaluable baseline and post-baseline values of generalized tonic-clonic (GTC) seizure frequency as the efficacy analysis, excluding those patients who seriously violated Good Clinical Practice (GCP).||percent change||95% Confidence Interval|Median
694666|NCT01398956|Primary|Incidence of Treatment Emergent Adverse Events During the Entire Study Period||Through study completion, an average of 3 years|The Safety Set (SS) consisted of all subjects who took at least one dose of study medication in this study.||Treatment Emergent Adverse Events|||Number
694667|NCT01398943|Secondary|Pulse Wave Velocity|A measure of vascular stiffness at baseline and several hours after each experimental intervention.|Post PWV was taken approximately 90 min after baseline|Patients diagnosed with COPD compared to healthy age-matched controls.||m/sec||Standard Deviation|Mean
694668|NCT01398943|Primary|Flow-Mediated Dilation (FMD)|Brachial artery FMD induced by reactive hyperemia will be used to assess vascular endothelial function at baseline and several hours after each experimental intervention.|Post FMD was taken approximately 110 min after baseline|Participants included patients diagnosed with COPD and healthy age-matched controls.||percentage of change in FMD||Standard Deviation|Mean
694669|NCT01398852|Primary|Changes in Corneal Curvature||24 MO|The CXL-003 study was terminated and data analysis was not done. The sponsor, Topcon Medical Systems, decided to terminate the study for administrative reasons only, and not as a result of any safety issues or concerns relating to the study.|||||
694670|NCT01398839|Primary|Changes in Corneal Curvature||6 Months|The CXL-002 study was terminated and data analysis was not done. The sponsor, Topcon Medical Systems, decided to terminate the study for administrative reasons only, and not as a result of any safety issues or concerns relating to the study.|||||
694671|NCT01398787|Primary|Percent Positive Purchase Intent (Definitely Would Buy, Probably Would Buy)|"The participant compared Pair 1 study lenses and indicated purchase intent by answering the following question, Assuming these lenses were at a price you would expect to pay, how likely would you be to purchase these lenses? using a 5-point Likert scale (definitely would buy, probably would buy, might or might not buy, probably would not buy, definitely would not buy). The combined percentage of the top two responses (definitely would buy, probably would buy) is reported. Each lens was assessed separately. This outcome measure was pre-specified for Analysis Population 1 (AP1)."|Day 1, 2-10 minutes after lens insertion|The analysis population includes all enrolled and exposed participants in AP1, minus any discontinuations, missing responses, or protocol violations as determined by masked review.||Percentage of participants|||Number
694672|NCT01398787|Primary|Percent Positive Responses: Cosmetic Appearance (Strongly Agree, Agree)|The participant compared the cosmetic appearance of Pair 1 study lenses on eye and answered 9 appearance-related questions using a 4-point Likert scale (strongly agree, agree, disagree, strongly disagree). The combined percentage of the top two responses (strongly agree, agree) is reported for each question. Each lens was assessed separately. This outcome measure was pre-specified for Analysis Population 1 (AP1).|Day 1, 2-10 minutes after lens insertion|The analysis population includes all enrolled and exposed participants in AP1, minus any discontinuations, missing responses, or protocol violations as determined by masked review.||Percentage of participants|||Number
694673|NCT01398787|Primary|Subjective Rating of Initial Comfort|The participant compared the initial comfort (way it feels) of Pair 1 study lenses and rated initial comfort using a 10-point scale (1=poor, 10=excellent). Each lens was assessed separately. This outcome measure was pre-specified for Analysis Population 1 (AP1).|Day 1, 2 minutes after lens insertion|The analysis population includes all enrolled and exposed participants in AP1, minus any discontinuations, missing responses, or protocol violations as determined by masked review.||Units on a scale||Standard Deviation|Mean
694674|NCT01398787|Primary|Appearance Preference|The participant compared the appearance (way it looks) of Pair 1 study lenses on eye and indicated preference using a 4-point Likert scale (prefer lens in the left eye, prefer lens in the right eye, no preference, or both eyes are equal). Appearance preference is reported as the percentage of participants who preferred the study lens. Each lens was assessed separately. This outcome measure was pre-specified for Analysis Population 1 (AP1).|Day 1, 2-10 minutes after lens insertion|The analysis population includes all enrolled and exposed participants in AP1, minus any discontinuations, missing responses, or protocol violations as determined by masked review.||Percentage of participants|||Number
694675|NCT01398787|Primary|Initial Comfort Preference|The participant compared the initial comfort (way it feels) of Pair 1 study lenses and indicated preference using a 4-point Likert scale (prefer lens in the left eye, prefer lens in the right eye, no preference, or both eyes are equal). Initial comfort preference is reported as the percentage of participants who preferred the study lens. Each lens was assessed separately. This outcome measure was pre-specified for Analysis Population 1 (AP1).|Day 1, 2 minutes after lens insertion|The analysis population includes all enrolled and exposed participants in AP1, minus any discontinuations, missing responses, or protocol violations as determined by masked review.||Percentage of participants|||Number
694676|NCT01398787|Primary|Overall Preference|The participant compared Pair 1 study lenses on eye and indicated overall preference using a 4-point Likert scale (prefer lens in the left eye, prefer lens in the right eye, no preference, or both eyes are equal). Overall preference is reported as the percentage of participants who preferred the study lens. Each lens was assessed separately. This outcome measure was pre-specified for Analysis Population 1 (AP1).|Day 1, 2-10 minutes after lens insertion|The analysis population includes all enrolled and exposed participants in AP1, minus any discontinuations, missing responses, or protocol violations as determined by masked review.||Percentage of participants|||Number
694677|NCT01398514|Primary|Physiological Reactivity as Measured by Square-root Transformed Skin Conductance Conditioned Response in Acquisition Trials 1 to 5|"Three-way interaction between group (active vs. placebo), CS (+ vs. -), and trials (1 - 5).
CS+ refers to the conditioned stimulus associated with the unconditioned stimulus (electric shock). Higher numbers reflect higher skin conductance response to the CS+ (conditioned stimulus).
CS- refers to the stimulus not associated with the unconditioned stimulus. Higher numbers reflect higher skin conductance response to a CS-.
Square-root transformed skin conductance conditioned response are reported for trials 1 to 5 of the Acquisition Phase."|Baseline on Day 1 of Fear Conditioning Paradigm (14 to 17 days post medication initiation)|||micro-Siemens (square rooted)||Standard Error|Mean
694678|NCT01398514|Primary|Physiological Reactivity as Measured by Square-root Transformed Skin Conductance Conditioned Response in Early Extinction Trials 1 to 4|"Three-way interaction between group (active vs. placebo), CS (+ vs. -), and trials (1 - 4).
CS+ refers to the conditioned stimulus associated with the unconditioned stimulus (electric shock). Higher numbers reflect higher skin conductance response to the CS+ (conditioned stimulus).
CS- refers to the stimulus not associated with the unconditioned stimulus. Higher numbers reflect higher skin conductance response to a CS-.
Square-root transformed skin conductance conditioned response are reported for trials 1 to 4 of the Early Extinction Phase."|Day 2 of Fear Conditioning Paradigm (15 to 18 days post medication initiation)|||micro-Siemens (square rooted)||Standard Error|Mean
694679|NCT01398475|Secondary|Pharmacokinetics: Time to Maximum Plasma Concentration (Tmax)||Predose up to 48 hours postdose for each of the 4 treatment periods|Randomized participants who received at least 1 dose of study drug.||hours (h)||Full Range|Median
694680|NCT01398475|Secondary|Pharmacokinetics: Maximum Plasma Concentration (Cmax)||Predose up to 48 hours postdose for each of the 4 treatment periods|Randomized participants who received at least 1 dose of study drug.||nanomoles per liter (nmol/L)||Geometric Coefficient of Variation|Geometric Mean
694681|NCT01398475|Primary|Pharmacokinetics: Plasma Concentration-Time Curve (AUC)|The area under the concentration-time curve from time 0 to infinity [AUC(0-inf)] is reported for participants who received either LY3009104 tablets or capsules in a fasted or fed state.|Predose up to 48 hours postdose for each of the 4 treatment periods|Randomized participants who received at least 1 dose of study drug.||nanomoles*hours per liter (nmol*h/L)||Geometric Coefficient of Variation|Geometric Mean
694682|NCT01398410|Secondary|Cumulative Recurrent Rate of Gastric or Duodenal Ulcers|Mucosal injuries with a white coat measuring greater than or equal to 3 mm in diameter was diagnosed as ulcers. When ulcer was confirmed by endoscopic examination during the trial, it was regarded as recurrence of ulcer and the trial was discontinued for the participant involved. The presence or absence of ulcer recurrence was determined by the endoscopy central review panel that were blinded to the investigators' assessments. Cumulative recurrent rate was estimated by the Kaplan-Meier method. The data is presented as percentage of participants with cumulative recurrent rate of gastric or duodenal ulcers.|Baseline, Week 12, Week 24, Week 52, and Week 76 (including data from the Double-Blind Phase)|The analysis was performed using Full Analysis Set, defined as all participants who received at least one dose of rabeprazole, with at least one post-initiation endoscopic assessment results, and showed no ulcers on baseline endoscopy; excluding participants from the newly-initiated rabeprazole groups of study E3810-J081-309.||Percentage of participants||95% Confidence Interval|Number
694683|NCT01398410|Primary|Percentage of Participants With Treatment Emergent Adverse Events (AEs)|An AE was defined as any untoward medical occurrence in a participant administered with the study drug. A serious adverse event (SAE) was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening (ie, the participant was at immediate risk of death from the AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was as a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug up to 30 days after the final dose of study drug) were assessed. The data is presented as percentage of participants with treatment emergent AEs.|For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug (rabeprazole) or up to 76 weeks (including data from the Double-Blind Phase)|The analysis was performed using Safety Analysis Set, defined as all participants who received at least one dose of rabeprazole.||Percentage of participants|||Number
694684|NCT01398176|Primary|Physiological Modifications to Gamma Delta T Cell Function|Proliferation of γδ-T cells when cultured ex vivo in autologous serum. Values are expressed as a percent of CD3 cells, which means a percent of the total T cell population. Only T cells express CD3.|4 weeks|Intent to treat||percent of T lymphocytes||Standard Error|Mean
694685|NCT01397890|Secondary|COPD Exacerbations|Severe exacerbations requiring systemic steroids (oral ≥3 days or parenteral) or hospitalisation or emergency room treatment due to worsening of COPD symptoms|Whole treatment period of 12 weeks|FAS (287 + 290); less number of patients analyzed was caused by missing values.||exacerbations/participant/12 weeks||95% Confidence Interval|Least Squares Mean
694686|NCT01397890|Secondary|Change in COPD Symptoms - Sputum|Change in Sputum symptom score (from 0:none to 4:severe) from run-in period|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements in the whole treatment period of 12 weeks|FAS (287 + 290); less number of patients analyzed was caused by missing values.||score on a scale||95% Confidence Interval|Least Squares Mean
694687|NCT01397890|Secondary|Change in COPD Symptoms - Cough|Change in Cough symptom score (from 0:none to 4:severe) from run-in period|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements in the whole treatment period of 12 weeks|FAS (287 + 290); less number of patients analyzed was caused by missing values.||score on a scale||95% Confidence Interval|Least Squares Mean
694688|NCT01397890|Secondary|Change in COPD Symptoms - Breathing|Change in breathing symptom score (from 0:none to 4:severe) from run-in period|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements in the whole treatment period of 12 weeks|FAS (287 + 290); less number of patients analyzed was caused by missing values.||score on a scale||95% Confidence Interval|Least Squares Mean
694689|NCT01397890|Secondary|Use of Reliever Medication During Night in the Whole Treatment Period|Change in the number of inhalations of reliever medication during night from run-in period to the whole treatment period|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during day in the whole treatment period of 12 weeks|FAS (287 + 290); less number of patients analyzed was caused by missing values.||times/day||95% Confidence Interval|Least Squares Mean
694690|NCT01397890|Secondary|Use of Reliever Medication During Night in the First Week on Treatment|Change in the number of inhalations of reliever medication during day from run-in period to the first week on treatment|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during night in the first week on treatment|FAS (287 + 290); less number of patients analyzed was caused by missing values.||times/day||95% Confidence Interval|Least Squares Mean
694691|NCT01397890|Secondary|Use of Reliever Medication During Night in the Last Week on Treatment|Change in the number of inhalations of reliever medication during night from run-in period to the last week on treatment|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during day in the last week on treatment, up to 12 weeks|FAS (287 + 290); less number of patients analyzed was caused by missing values.||times/day||95% Confidence Interval|Least Squares Mean
694692|NCT01397890|Secondary|Use of Reliever Medication During Day in the Whole Treatment Period|Change in the number of inhalations of reliever medication during day from run-in period to the whole treatment period|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during day in the whole treatment period of 12 weeks|FAS (287 + 290); less number of patients analyzed was caused by missing values.||times/day||95% Confidence Interval|Least Squares Mean
694693|NCT01397890|Secondary|Use of Reliever Medication During Day in the First Week on Treatment|Change in the number of inhalations of reliever medication during day from run-in period to the first week on treatment|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during day in the first week on treatment|FAS (287 + 290); less number of patients analyzed was caused by missing values.||times/day||95% Confidence Interval|Least Squares Mean
694694|NCT01397890|Secondary|Use of Reliever Medication During Day in the Last Week on Treatment|Change in the number of inhalations of reliever medication during day from run-in period to the last week on treatment|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during day in the last week on treatment, up to 12 weeks|FAS (287 + 290); less number of patients analyzed was caused by missing values.||times/day||95% Confidence Interval|Least Squares Mean
694695|NCT01397890|Secondary|Post-dose PEF in Whole Treatment Period|Change in post-dose morning PEF at 5 minutes from run-period to whole treatment period|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured at 5 minutes after inhalation of study drug in whole treatment period of 12 weeks|FAS (287 + 290); less number of patients analyzed was caused by missing values.||L/min||95% Confidence Interval|Least Squares Mean
694696|NCT01397890|Secondary|Post-dose PEF in First Week of Treatment|Change in post-dose morning PEF at 5 minutes from run-in period to first week of treatment|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured at 5 minutes after inhalation of study drug in the first week of treatment|FAS (287 + 290); less number of patients analyzed was caused by missing values.||L/min||95% Confidence Interval|Least Squares Mean
694697|NCT01397890|Secondary|Post-dose PEF in Last Week of Treatment|Change in post-dose morning PEF at 5 minutes from run-period to last week of treatment|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured at 5 minutes after inhalation of study drug in the last week of treatment, up to 12 weeks|FAS (287 + 290); less number of patients analyzed was caused by missing values.||L/min||95% Confidence Interval|Least Squares Mean
694698|NCT01397890|Secondary|Pre-dose PEF in Whole Treatment Period|Change in pre-dose morning PEF from run-in period to whole treatment period|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured before inhalation of study drug in whole treatment period of 12 weeks|FAS (287 + 290); less number of patients analyzed was caused by missing values.||L/min||95% Confidence Interval|Least Squares Mean
694699|NCT01397890|Secondary|Pre-dose PEF in First Week of Treatment|Change in pre-dose morning PEF (Peak Expiratory Flow) from run-in period to first week of treatment|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured before inhalation of study drug in the first week of treatment|FAS (287 + 290); less number of patients analyzed was caused by missing values.||L/min||95% Confidence Interval|Least Squares Mean
694700|NCT01397890|Secondary|Pre-dose PEF in Last Week of Treatment|Change in pre-dose morning PEF (Peak Expiratory Flow) from run-in period to last week of treatment|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured before inhalation of study drug in the last week of treatment, up to 12 weeks|FAS (287 + 290); less number of patients analyzed was caused by missing values.||L/min||95% Confidence Interval|Least Squares Mean
694701|NCT01397890|Secondary|Post-dose IC at 60 Minutes|Ratio of post-dose IC at 60 minutes to baseline value|Baseline (measured before inhalation of study drug at week 0) and mean in treatment period (measured at 1 hour after inhalation of study drug at weeks 0, 1, 6, 12)|FAS (287 + 290); less number of patients analyzed was caused by missing values.||Ratio||95% Confidence Interval|Geometric Mean
694702|NCT01397890|Secondary|Pre-dose IC|Ratio of pre-dose IC (Inspiratory Capacity) in treatment period to baseline value|Baseline (week 0) and mean in treatment period (weeks 1, 6, 12) measured before inhalation of study drug|FAS (287 + 290); less number of patients analyzed was caused by missing values.||Ratio||95% Confidence Interval|Geometric Mean
694976|NCT01395914|Primary|Percentage of Participants With Treatment-emergent Adverse Events|To Evaluate the Safety and Tolerability of Anamorelin HCl.|Over the 12-week treatment period|Safety Population, defined as patients who received any extension trial study drug.||percentage of participants|||Number
694703|NCT01397890|Secondary|Post-dose FVC at 60 Minutes|Ratio of post-dose FVC at 60 minutes to baseline value|Baseline (measured before inhalation of study drug at week 0) and mean in treatment period (measured at 1 hour after inhalation of study drug at weeks 0, 1, 6, 12)|FAS (287 + 290); less number of patients analyzed was caused by missing values.||Ratio||95% Confidence Interval|Geometric Mean
694704|NCT01397890|Secondary|Post-dose FVC at 5 Minutes|Ratio of post-dose FVC at 5 minutes to baseline value|Baseline (measured before inhalation of study drug at week 0) and mean in treatment period (measured at 5 minutes after inhalation of study drug at weeks 0, 1, 6, 12)|FAS (287 + 290); less number of patients analyzed was caused by missing values.||Ratio||95% Confidence Interval|Geometric Mean
694705|NCT01397890|Secondary|Pre-dose FVC|Ratio of pre-dose FVC (Forced Vital Capacity) in treatment period to baseline value|Baseline (measured before inhalation of study drug at week 0) and mean in treatment period (measured at 1 hour after inhalation of study drug at weeks 0, 1, 6, 12)|FAS (287 + 290); less number of patients analyzed was caused by missing values.||Ratio||95% Confidence Interval|Geometric Mean
694706|NCT01397890|Secondary|Post-dose FEV1 at 60 Minutes|Ratio of post-dose FEV1 at 60 minutes to baseline value|Baseline (measured before inhalation of study drug at week 0) and mean in treatment period (measured at 1 hour after inhalation of study drug at weeks 0, 1, 6, 12)|FAS (287 + 290); less number of patients analyzed was caused by missing values.||Ratio||95% Confidence Interval|Geometric Mean
694707|NCT01397890|Secondary|Post-dose FEV1 at 5 Minutes|Ratio of post-dose FEV1 at 5 minutes to baseline value|Baseline (-2 weeks) and mean in treatment period (1, 6, 12 weeks) measured at 5 minutes after inhalation of study drug|FAS (287 + 290); less number of patients analyzed was caused by missing values.||Ratio||95% Confidence Interval|Geometric Mean
694708|NCT01397890|Primary|Pre-dose FEV1|Ratio of pre-dose FEV1 (Forced Expiratory Volume in 1 second) in treatment period to baseline value|Baseline (week 0) and mean in treatment period (weeks 1, 6, 12) measured before inhalation of study drug|FAS (287 + 290); less number of patients analyzed was caused by missing values.||Ratio||95% Confidence Interval|Geometric Mean
694709|NCT01397851|Secondary|Self-reported Malaria Prevalence|Over two weeks before interview, collected through validation survey. Odds ratio calculated in accordance with NIH guidance http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2938757/|2010-2011 season (up to 1 year)|Subset of study population selected for validation survey||odds ratio|||Number
694710|NCT01397851|Secondary|Increase in Maize Productivity|Increase in self-reported maize productivity (yield on maize plots divided by size of maize plots), collected through validation survey; calculated as maize productivity 2010-11 minus maize productivity 2009-10, measured in bags (ordinarily 50kg bags; however, kg measure not specified)|2009-2010 and 2010-2011 seasons (up to 2 years)|Subset of study population selected for validation survey||bags (not further specified)||Standard Error|Mean
694711|NCT01397851|Secondary|Contract Defaults|Defaults on input loans, as defined in the routine data collection system of the participating cotton outgrowing agribusiness. Odds ratios calculated in accordance with NIH guidance: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2938757/|2010-2011 season (up to 1 year)|||odds ratio|||Number
694712|NCT01397851|Primary|Cotton Yields|Farmer's cotton yields (kg delivered per household), as defined in the routine data collection system of the participating cotton outgrowing agribusiness|2010-2011 season (up to 1 year)|||kg||Standard Deviation|Mean
694713|NCT01397786|Secondary|Mean Change From Baseline in PANSS Marder Factor Scores - Anxiety/Depression Score|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The anxiety/depression factor score is the sum of score from the 4 items (anxiety (G2), guilt feelings (G3), tension (G4) and depression (G6)) on the anxiety/depression subscale (range: 4 - best possible outcome to 28 - worst possible outcome).|From Baseline up to 52 Weeks|The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score.||Units on a scale||Standard Deviation|Mean
694714|NCT01397786|Secondary|Mean Change From Baseline in PANSS Marder Factor Scores - Hostility/ Excitement Score|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The uncontrolled hostility/excitement factor score is the sum of score from the 4 items (excitement (P4), hostility (P7), uncooperativeness (G8) and poor impulse control (G14)) on the uncontrolled hostility/excitement subscale (range: 4 - best possible outcome to 28 - worst possible outcome).|From Baseline up to 52 Weeks|The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score.||Units on a scale||Standard Deviation|Mean
694715|NCT01397786|Secondary|Mean Change From Baseline in PANSS Marder Factor Scores - Disorganized Thought Score|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The disorganized thoughts factor score is the sum of score from the 7 items (conceptual disorganization (P2), difficulty in abstract thinking (N5), mannerisms and posturing (G5), disorientation (G10), poor attention (G11), disturbance of volition (G13) and preoccupation (G15)) on the disorganized thoughts subscale (range: 7 - best possible outcome to 49 - worst possible outcome).|From Baseline up to 52 Weeks|The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score.||Units on a scale||Standard Deviation|Mean
694725|NCT01397786|Secondary|Mean Change From Baseline in PANSS Positive Subscale Score|The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. In positive subscale, the 7 positive symptom constructs were: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility.|From Baseline up to 52 Weeks|The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score.||Units on a scale||Standard Deviation|Mean
694716|NCT01397786|Secondary|Mean Change From Baseline in PANSS Marder Factor Scores - Negative Symptoms Score|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The negative factor score is the sum of the 7 items (blunted affect (N1), emotional withdrawal (N2), poor rapport (N3), passive/apathetic social withdrawal (N4), lack of spontaneity and conversation flow (N6), motor retardation (G7) and active social avoidance (G16)) of the negative subscale (range: 8 - best possible outcome to 56 - worst possible outcome).|From Baseline up to 52 Weeks|The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score.||Units on a scale||Standard Deviation|Mean
694717|NCT01397786|Secondary|Mean Change From Baseline in PANSS Marder Factor Scores - Positive Symptoms Score|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The positive factor score was the sum of the 8 components (delusions (P1), hallucinatory behavior (P3), grandiosity (P5), suspiciousness/persecution (P6), stereotyped thinking (N7), somatic concern (G1), unusual thought content (G9) and lack of judgment and insight (G12)) of the positive symptoms scale (range: 8 - best possible outcome to 56 - worst possible outcome).|From Baseline up to 52 Weeks|The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score.||Units on a scale||Standard Deviation|Mean
694718|NCT01397786|Secondary|Mean Change From Baseline in Positive and Negative Syndrome Scale Excited Component Score|The PEC score consisted of five PANSS items: excitement (P4), hostility (P7), tension (G4), uncooperativeness (G8), and poor impulse control (G14). Each of the items were rated on a scale of 1 (absent) to 7 (extreme). The PEC scores ranged from 5 (not present) to 35 (extremely severe).|From Baseline up to 52 Weeks|The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score.||Units on a scale||Standard Deviation|Mean
694719|NCT01397786|Secondary|Discontinuation Rate for Lack of Efficacy|Discontinuation rate for the participants who discontinued due to lack of efficacy were examined.|From Baseline up to 52 Weeks|The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score.||percentage of participants|||Number
694720|NCT01397786|Secondary|Response Rate|Response rate was defined as a reduction of ≥ 30% from Baseline in PANSS total score or CGI-I score of 1 (very much improved) or 2 (much improved) at the Last Visit.|From Baseline up to 52 Weeks|The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score.||percentage of participants|||Number
694721|NCT01397786|Secondary|Mean Clinical Global Impression - Improvement Score|The efficacy of study medication was rated for each participant using the CGI-I. The investigator rated the participant's total improvement whether or not it was due to the drug treatment. All responses were compared to the participant's condition at Screening/Baseline (i.e, Week 6 visit of Protocol NCT00905307). Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.|From Baseline up to 52 Weeks|The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score.||Units on a scale||Standard Deviation|Mean
694722|NCT01397786|Secondary|Mean Change From Baseline in Personal and Social Performance Scale Total Score|The PSP was a validated clinician-rated scale that measured personal and social functioning in four domains: socially useful activities (e.g, work and study), personal and social relationships, self-care, and disturbing and aggressive behaviors. Impairment in each of these domains was rated as absent, mild, manifest, marked, severe, or very severe. These ratings were then converted to a total score based on a 100-point scale using algorithms to identify the appropriate 10-point interval, and the rater’s judgment that determined the total score within the 10-point interval. Participants with a PSP total score of 71 to 100 were considered to have mild functional difficulty. Scores of 31 to 70 represented manifest disabilities of various degrees and ratings of 1 to 30 indicated minimal functioning that required intense support and/or supervision.|From Baseline up to 52 Weeks|The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score.||Units on a scale||Standard Deviation|Mean
694723|NCT01397786|Secondary|Mean Change From Baseline in Clinical Global Impression - Severity of Illness Scale Score|The severity of illness for each participant was rated using the CGI-S. To perform this assessment, the investigator were to answer the following question: “Considering your total clinical experience with this particular population, how mentally ill was the participant at that time?” Response choices include: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.|From Baseline up to 52 Weeks|The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score.||Units on a scale||Standard Deviation|Mean
694724|NCT01397786|Secondary|Mean Change From Baseline in PANSS Negative Subscale Score|The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. In negative subscale the severity was rated for the following 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking.|From Baseline up to 52 Weeks|The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score.||Units on a scale||Standard Deviation|Mean
694775|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The term myocardial infarction should be used when there is evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.|3 years|ITT population.This analysis represents those subjects who were event free at this time point.||percentage of participants|||Number
694726|NCT01397786|Secondary|Mean Change From Baseline in Positive and Negative Syndrome Scale Total Score|The PANSS consisted of 3 subscales with 30 symptom constructs (positive subscale (7): delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/perseckion, and hostility; negative subscale (7): blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and conversation flow, stereotyped thinking and general psychopathology subscale (16): somatic concern, anxiety, guilt feelings, tension, mannerisms and posturing, depression, motor retardation, uncooperativeness, unusual thought content, disorientation, poor attention, lack of judgment and insight, disturbance of volition, poor impulse control, preoccupation, and active social avoidance). Severity was rated on 7-point scale with scores 1 (absence) & 7 (extremely severe). The PANSS total score was sum of rating scores for 7 positive, 7 negative, and 16 general psychopathology subscale items of PANSS panel.|From Baseline up to 52 Weeks|The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score.||Units on a scale||Standard Deviation|Mean
694727|NCT01397786|Primary|Percentage of Participants With Adverse Events (AEs)|A treatment-emergent adverse event (TEAE) is defined as an AE that started after start of investigational medicinal product (IMP) treatment; or if the event was continuous from baseline and was serious, IMP-related, or resulted in death, discontinuation, interruption or reduction of IMP.|From Baseline up to 52 Weeks|Safety sample included those participants who had at least one post-baseline efficacy evaluation for Positive and Negative Syndrome Scale (PANSS) total score.||percentage of participants|||Number
694728|NCT01397747|Primary|Sensitivity and Specificity of the Exact CRC Screening Test With Comparison to Colonoscopy, Both With Respect to Cancer.|An optical colonoscopic procedure is the reference method. Lesions will be confirmed as malignant by histopathologic examination. The DNA test includes quantitative molecular assays for KRAS mutations, aberrant NDRG4 and BMP3 methylation, and Beta-actin, plus a hemoglobin immunoassay. Results were generated with the use of a logistic-regression algorithm, with values of 183 or more considered to be positive. FIT values of more than 100 ng of hemoglobin per milliliter of buffer were considered to be positive. Tests were processed independently of colonoscopic findings. The test functions as a screening tool by generating a score, based on the detection of hemoglobin and multiple DNA methylation and mutational markers, together with an assessment of the total amount of human DNA in each sample. Sensitivity= 100*(multitarget DNA or FIT positive test/positive colonoscopy); Specificity= 100*(multitarget DNA or FIT negative test/negative colonoscopy).|90 Days|||percent||95% Confidence Interval|Number
694729|NCT01397617|Secondary|Implant Survival Rate From the Time of Implant Insertion to Follow-up Visits (3,6,12,24,36 and 60 Months).|An implant was reported to be a surviving implant when it remained in the jaw and was functionally loaded even if not all the individual success criteria were fulfilled (i) an implant that causes no allergic, toxic or gross infectious reactions either locally or systemically, ii) offered anchorage to a functional prosthesis, iii) showed no signs of fracture or bending, iv) showed no signs of peri-implant radiolucency on an intraoral radiograph using a paralleling technique strictly perpendicular to the implant-bone interface, and v) showed no mobility when individually tested by either tapping or rocking with a hand instrument).|baseline, 3 months, 6 months, 12 months, 24 months, 36 months and 60 months|Intention to treat analysis.||percentage of surviving implants|Participants||Number
694730|NCT01397617|Primary|The Primary Endpoint Was the Change in Marginal Bone Levels (in mm) From the Time of Implant Insertion to Follow-up Visits (3,6,12,24,36 and 60 Months).|"Marginal bone remodeling is calculated for each side of the implant (mesial and distal) separately, as the difference between bone levels at two time points. The average of mesial and distal remodeling is then calculated for each implant site (paired for each side between two different points). Negative numbers indicate bone loss. Implant insertion was defined as a baseline.
Missing data was not imputed and not included in evaluation."|baseline, 3 months, 6 months, 12 months, 24 months, 36 months and 60 months|Intent to treat analysis (all participants who received at least one implant were analyzed). Missing data was not imputed and not included in evaluation.||mm||Standard Deviation|Mean
694731|NCT01397591|Secondary|Number of Participants With Adverse Events (Toxicity)|Toxicities and adverse experiences will be assessed at each visit using the NCI Common Toxicity Criteria for Adverse Events v4.0 Interim analyses on toxicity will be implemented based on the toxicity endpoints of the first 6 patients, and will be conducted sequentially 4 weeks after the treatment of each patient, or when serious toxicity has been observed for the patient, whichever comes earlier. we assume a non-informative prior distribution (Beta (0.001, 0.001)) for toxicity rate, and compute the posterior distribution of toxicity rate sequentially.|Days 1, 8, and 15 of each course and 4-6 weeks after final treatment|||participants|||Number
694732|NCT01397591|Secondary|Disease Free Survival|The period of time between complete remission and recurrence of disease.|Up to every 3 months for 2 years|Study closed by PI due to lack of accrual before this outcome measure could be analyzed.|||||
694733|NCT01397591|Secondary|Progression Free Survival|This outcome measure is defined as the length of time after treatment during which the patient survives with no sign of the disease.|Up to every 3 months for 2 years|Study closed by PI due to lack of accrual before this outcome measure could be analyzed.|||||
694734|NCT01397591|Secondary|Overall Survival|This outcome measure is defined as the time from initiation of treatment to death due to any cause.|Up to every 3 months for 2 years|Study closed by PI due to lack of accrual before this outcome measure could be analyzed.|||||
694735|NCT01397591|Primary|Response Rate of Ofatumumab in Combination With Bortezomib in Patients With Relapsed CD20+ (Cluster of DIfferentiation Antigen 20) Diffuse Large B Cell Lymphoma, Follicular Lymphoma, or Mantle Cell Lymphoma|Based on International Working Group (IWG) criteria, recorded in four categories: Complete Response (CR), disappearance of all evidence of disease; Partial Response (PR), regression of measurable disease and no new sites of disease; Progressive Disease (PD), Any new lesion or increase by >= 50% of previously involved sites from nadir. Stable Disease (SD), failure to attain CR/PR or PD. A response is defined to be either CR/PR. A failure in response includes SD/PD.|Every 2 cycles during treatment and then every 3 months for 2 years|||participants|||Number
694776|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The term myocardial infarction should be used when there is evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.|2 years|ITT population.This analysis represents those subjects who were event free at this time point.||percentage of participants|||Number
694736|NCT01397461|Primary|Clinical Success|"Clinical response (clinical success or clinical failure) at end of therapy (Visit 3) in the intent to treat clinical (ITTC) population.
Clinical succes at Visit 3 was defined as: SIRS score 0 for exudates/pus, crusting, tissue warmth and pain and no more than 1 each for erythema/inflammation, tissue edema and itching such that no additional antimicrobial therapy in the baseline (Visit 1) affected area is necessary.
The SIRS is a severity index based on seven signs or symptoms:
Exudate/pus
Crusting
Erythema/inflammation
Tissue warmth
Tissue oedema
Itching
Pain
Each sign/symptom is rated on a scale from 0 to 6:
0 = absent
1 2 = mild 3 4 = moderate 5 6 = severe"|2 weeks|||percentage of participants|||Number
694737|NCT01397448|Primary|Cumulative Recurrent Rates of Gastric or Duodenal Ulcers|Mucosal injuries with a white coat measuring 3 mm in diameter will be diagnosed as ulcers. When ulcer is confirmed by endoscopic examination during the trial, it will be regarded as recurrence of ulcer and the trial will be discontinued for the patient involved.|24 weeks|Defined as all randomized participants who received at least one dose of the study drug and showed no ulcers at baseline, and from whom the results of at least one endoscopic assessment was available.||Events/100 participants/24 weeks||95% Confidence Interval|Number
694738|NCT01397448|Secondary|Cumulative Incidence of Bleeding Ulcers||24 weeks|Defined as all randomized participants who received at least one dose of the study drug and showed no ulcers at baseline, and from whom the results of at least one endoscopic assessment was available.||Events/100 participants/24 weeks||95% Confidence Interval|Number
694739|NCT01397409|Secondary|Stage 3: Change From Baseline in BCVA in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|Baseline, Week 4|Per-protocol Population included all treated participants who received all scheduled treatments.||letters||Standard Deviation|Mean
694740|NCT01397409|Secondary|Stage 3: Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye|CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from Baseline indicated improvement.|Baseline, Week 4|Per-protocol Population included all treated participants who received all scheduled treatments.||microns||Standard Deviation|Mean
694741|NCT01397409|Secondary|Stage 2: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|Baseline, Week 4|Per-protocol Population included all treated participants who received all scheduled treatments.||letters||Standard Deviation|Mean
694742|NCT01397409|Secondary|Stage 2: Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye|CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from Baseline indicated improvement.|Baseline, Week 4|Per-protocol Population included all treated participants who received all scheduled treatments.||microns||Standard Deviation|Mean
694743|NCT01397409|Secondary|Stage 2: Time Between Second Treatment and Recurrence of Active Disease|Recurrence of active disease is defined as the time in days to escape to standard of care. Time is calculated as (date of Escaping to Standard of Care/Censoring minus the date of the Second Injection) +1.|32 Weeks|mITT Population||days||Inter-Quartile Range|Median
694744|NCT01397409|Primary|Stage 3: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|Baseline, Week 16|Modified-Intent-to-Treat (mITT) Population||letters||Standard Deviation|Mean
694745|NCT01397409|Primary|Stage 2: Time Between Baseline Treatment and Recurrence of Active Disease|Recurrence of Active Disease was based on Best Corrected Visual Acuity (BCVA), Central Retinal Thickness (CRT) values as evaluated by the Central Reading Center (CRC) and the investigator assessments of haemorrhage.|Baseline, Week 16|Per-protocol Population included all treated participants who received all scheduled treatments.||days||Inter-Quartile Range|Median
694746|NCT01397409|Primary|Stage 1: Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye|CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from Baseline indicated improvement.|Baseline, Week 4|Safety population included all treated participants.||microns||Standard Deviation|Mean
694747|NCT01397409|Primary|Highest Tolerated Dose (HTD) of AGN-150998|Stage 1 evaluated the safety of a single intravitreal injection of AGN-150998 with doses ranging from 1.0 to 4.2 mg.|24 Weeks|Safety population included all treated participants.||mg|||Number
694748|NCT01397253|Secondary|Patient PCP Visits, Emergency Room Visits and Rehospitalizations Within 30 Days Post-discharge.|Details regarding patient PCP follow-up office appointments, ER visits and rehospitalizations occuring within 30 days post-discharge will be collected from the EMR.|Within 30 post-discharge from hospital||||||
694749|NCT01397253|Primary|Medication Errors at Hospital Discharge|Medication name, dose, and frequency of administration for patient pre-admission medications will be recorded. Medications received during the hospitalization and discharge medications will be obtained by medical record review following hospital discharge. Pre-admission medications will be compared to discharge medications and differences will be considered discharge medication variances. Two trained pharmacists will independently review medication variances to determine clinical indications or medication errors.|Approximately 1-30 days|Hospitalized medical patients with ≥2 comorbidities and ≥5 chronic medications, at a single center||Errors|Participants||Number
694777|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The term myocardial infarction should be used when there is evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.|18 months|ITT population. This analysis represents those subjects who were event free at this time point.||percentage of participants|||Number
694750|NCT01397084|Secondary|Change in the Maximum Severity of Heartburn During the 7-day Period Prior to the 8 Week Visit (Visit 3) Compared to the Maximum Severity of Heartburn During the 7-day Period Prior to Baseline (Visit 1).|"Maximum severity of heartburn during 7 days at baseline and at 8 weeks was obtained (None, Mild, Moderate, Severe). If the value at 8 weeks was better than at baseline in a participant, the participant was s categorized into Improved. If the value was same, then categorised into Unchanged. If the value was worsened, categorised into Worsened."|Baseline and 8 weeks|Efficacy Population (104 participants)||Participants|||Number
694751|NCT01397084|Secondary|Change in the Maximum Severity of Heartburn During the 7-day Period Prior to the 4 Week Visit (Visit 2) Compared to the Maximum Severity of Heartburn During the 7-day Period Prior to Baseline (Visit 1).|"Maximum severity of heartburn during 7 days at baseline and at 4 weeks was obtained (None, Mild, Moderate, Severe). If the value at 4 weeks was better than at baseline in a participant, the participant was s categorized into Improved. If the value was same, then categorised into Unchanged. If the value was worsened, categorised into Worsened."|Baseline and 4 weeks.|101 Participants out of efficacy population (104 participants) who had data related to heartburn at Week 4 were used.||Participants|||Number
694752|NCT01397084|Secondary|Change in the Frequency of Heartburn During the 7-day Period Prior to the 4 Week Visit (Visit 2) Compared to the Frequency of Heartburn During the 7-day Period Prior to Baseline (Visit 1).|The number of days with heartburn during the 7-day period prior to the 4 week visit (Visit 2) was compared to the number of days with heartburn during the 7-day period prior to baseline (Visit 1). The difference in the number of days with heartburn from baseline to 4 weeks was analysed.|Baseline and 4 weeks|101 Participants out of efficacy population (104 participants) who had data related to heartburn at Week 4 were used.||Days with heartburn||Standard Deviation|Mean
694753|NCT01397084|Primary|Change in the Frequency of Heartburn During the 7-day Period Prior to the 8 Week Visit (Visit 3) Compared to the Frequency of Heartburn During the 7-day Period Prior to Baseline (Visit 1).|The number of days with heartburn during the 7-day period prior to the 8 week visit (Visit 3) was compared to the number of days with heartburn during the 7-day period prior to baseline (Visit 1). The difference in the number of days with heartburn from baseline to 8 weeks was analysed.|Baseline and 8 weeks|Efficacy Population (104 participants)||Days with heartburn||Standard Deviation|Mean
694754|NCT01396525|Secondary|Changes in Quality of Life Measures: Mental Component Summary|"This measure indicates the absolute change between two timepoints represented by the mean.
SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|Baseline and 3 years|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||score on a scale||Standard Deviation|Mean
694755|NCT01396525|Secondary|Changes in Quality of Life Measures: Mental Component Summary|"This measure indicates the absolute change between two timepoints represented by the mean.
SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|Baseline and 2 years|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||score on a scale||Standard Deviation|Mean
694756|NCT01396525|Secondary|Changes in Quality of Life Measures: Mental Component Summary|"This measure indicates the absolute change between two timepoints represented by the mean.
SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|Baseline and 9 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||score on a scale||Standard Deviation|Mean
694757|NCT01396525|Secondary|Changes in Quality of Life Measures: Mental Component Summary|"This measure indicates the absolute change between two timepoints represented by the mean.
SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|Baseline and 1 month|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||score on a scale||Standard Deviation|Mean
694758|NCT01396525|Secondary|Changes in Quality of Life Measures: Physical Component Summary|"This measure indicates the absolute change between two timepoints represented by the mean.
SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|Baseline and 3 years|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||score on a scale||Standard Deviation|Mean
694759|NCT01396525|Secondary|Changes in Quality of Life Measures: Physical Component Summary|"This measure indicates the absolute change between two timepoints represented by the mean.
SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|Baseline and 2 years|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||score on a scale||Standard Deviation|Mean
694760|NCT01396525|Secondary|Changes in Quality of Life Measures: Physical Component Summary|"This measure indicates the absolute change between two timepoints represented by the mean.
SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|Baseline and 9 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||score on a scale||Standard Deviation|Mean
694977|NCT01395901|Secondary|Proportion of Patients Without Nausea (Patient Aged > 6 Years)||0-24 hours after T0|The Full Analysis Set (FAS) population aged ≥ 6 years||percentage of patients||95% Confidence Interval|Number
694761|NCT01396525|Secondary|Changes in Quality of Life Measures: Physical Component Summary|"This measure indicates the absolute change between two timepoints represented by the mean.
SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|Baseline and 1 month|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||score on a scale||Standard Deviation|Mean
694762|NCT01396525|Secondary|Stent Thrombosis|Defined as a total occlusion documented by duplex ultrasound and/or arteriography at the stent site with or without symptoms that occurs ≤ 30 days post index procedure.|1 month|ITT population, per lesion analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||percentage of target lesions|Participants|95% Confidence Interval|Number
694763|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Amputations (Minor) of the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A minor amputation will be defined as below the ankle.|3 years|ITT population.This analysis represents those subjects with target limbs who were event free at this time point.||percentage of target limbs|Participants||Number
694764|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Amputations (Minor) of the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A minor amputation will be defined as below the ankle.|2 years|ITT population.This analysis represents those subjects with target limbs who were event free at this time point.||percentage of target limbs|Participants||Number
694765|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Amputations (Minor) of the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A minor amputation will be defined as below the ankle.|18 months|ITT population.This analysis represents those subjects with target limbs who were event free at this time point.||percentage of target limbs|Participants||Number
694766|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Amputations (Minor) of the Treated Limb(s)|Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A minor amputation will be defined as below the ankle.|1 month and 9 months|ITT population.This analysis represents those subjects with target limbs who were event free at this timepoint||percentage of target limbs|Participants||Number
694767|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Embolic Events|Outcome measure analyzed at 1 and 9 months and at 2 and 3 years. Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery.|3 years|ITT population.This analysis represents those subjects who were event free at this time point.||percentage of participants|||Number
694768|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Embolic Events|Outcome measure analyzed at 1 and 9 months and at 2 and 3 years. Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery.|2 years|ITT population.This analysis represents those subjects who were event free at this time point.||percentage of participants|||Number
694769|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Embolic Events|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery.|18 months|ITT population.This analysis represents those subjects who were event free at this timepoint||percentage of particpants|||Number
694770|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Embolic Events|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery.|1 month and 9 months|ITT population.This analysis represents those subjects who were event free at this timepoint||percentage of particpants|||Number
694771|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A major amputation will be defined as at or above the ankle.|3 years|ITT population.This analysis represents those subjects with target limbs who were event free at this time point.||percentage of target limbs|Participants||Number
694772|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A major amputation will be defined as at or above the ankle.|2 years|ITT population.This analysis represents those subjects with target limbs who were event free at this time point.||percentage of target limbs|Participants||Number
694773|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A major amputation will be defined as at or above the ankle.|18 months|ITT population.This analysis represents those subjects with target limbs who were event free at this time point.||percentage of target limbs|Participants||Number
694774|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)|Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A major amputation will be defined as at or above the ankle.|1 month and 9 months|ITT population.This analysis represents those subjects with target limbs who were event free at this timepoint||percentage of target limbs|Participants||Number
695478|NCT01389882|Secondary|Capillary Blood pH|Capillary blood pH checked immediately after the 4-hour respiratory support with each ventilator mode|four hours|"The analysis was per protocol. 19 patients who had completed the study was used for the analysis."||pH||Standard Deviation|Mean
694778|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The term myocardial infarction should be used when there is evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.|1 month and 9 months|ITT population. This analysis represents those subjects who were event free at this timepoint||percentage of participants|||Number
694779|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Death (All Cause)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years.|3 years|ITT population.This analysis represents those subjects who were event free at this time point.||percentage of participants|||Number
694780|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Death (All Cause)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years.|2 years|ITT population. This analysis represents those subjects who were event free at this time point.||percentage of participants|||Number
694781|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Death (All Cause)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years.|18 months|ITT population. This analysis represents those subjects who were event free at this time point.||percentage of participants|||Number
694782|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Death (All Cause)|Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years|1 month and 9 months|ITT population. This analysis represents those subjects who were event free at this timepoint.||percentage of participants|||Number
694783|NCT01396525|Secondary|Restenosis|Defined as ≥ 50% stenosis at follow-up.|3 years|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||percentage of limbs|Participants|95% Confidence Interval|Number
694784|NCT01396525|Secondary|Restenosis|Defined as ≥ 50% stenosis at follow-up.|2 years|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||percentage of limbs|Participants|95% Confidence Interval|Number
694785|NCT01396525|Secondary|Restenosis|Defined as ≥ 50% stenosis at follow-up.|9 months|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||percentage of limbs|Participants|95% Confidence Interval|Number
694786|NCT01396525|Secondary|Primary Stent Patency|Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure|3 years|ITT population, per lesion analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||percentage of limbs|Participants||Number
694787|NCT01396525|Secondary|Primary Stent Patency|Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure|2 years|ITT population, per lesion analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||percentage of limbs|Participants||Number
694788|NCT01396525|Secondary|Primary Stent Patency|Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure.|9 months|ITT population, per lesion analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||percentage of limbs|Participants||Number
694789|NCT01396525|Secondary|Primary Stent Patency|Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure.|1 month|ITT population, per lesion analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||percentage of limbs|Participants||Number
694790|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target extremity revascularization (TER) is defined as any revascularization of a target extremity vessel (distal to the superior border of the inguinal ligament on the ipsilateral side) with or without evidence of vessel diameter stenosis ≥ 50% determined by DUS or arteriography, and with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category).|3 years|ITT population. This analysis represents those subjects with vessels in the extremity with the target lesions who were event free at this timepoint.||percentage of limbs|Participants||Number
694791|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target extremity revascularization (TER) is defined as any revascularization of a target extremity vessel (distal to the superior border of the inguinal ligament on the ipsilateral side) with or without evidence of vessel diameter stenosis ≥ 50% determined by DUS or arteriography, and with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category).|2 years|ITT population. This analysis represents those subjects with vessels in the extremity with the target lesions who were event free at this timepoint.||percentage of limbs|Participants||Number
694792|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target extremity revascularization (TER) is defined as any revascularization of a target extremity vessel (distal to the superior border of the inguinal ligament on the ipsilateral side) with or without evidence of vessel diameter stenosis ≥ 50% determined by DUS or arteriography, and with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category).|18 months|ITT population. This analysis represents those subjects with vessels in the extremity with the target lesions who were event free at this timepoint.||percentage of limbs|Participants||Number
694793|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target extremity revascularization (TER) is defined as any revascularization of a target extremity vessel (distal to the superior border of the inguinal ligament on the ipsilateral side) with or without evidence of vessel diameter stenosis ≥ 50% determined by DUS or arteriography, and with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category).|1 month and 9 months|ITT population. This analysis represents those subjects with vessels in the extremity with the target lesions who were event free at this timepoint.||percentage of limbs|Participants||Number
695479|NCT01389882|Secondary|Fraction of Oxygen|Fraction of oxygen measured by a ventilator for 4 hours with each ventilator mode|four hours|||percentage of concentration||Full Range|Median
694794|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Clinically DrivenTarget Vessel Revascularization (TVR) for the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven Target Vessel Revascularization is defined as revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography).|3 years|ITT population. This analysis represents those subjects with lesions in target vessels who were event free at this timepoint.||percentage of target vessels|Participants||Number
694795|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Clinically Driven Target Vessel Revascularization (TVR) for the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven Target Vessel Revascularization is defined as revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography).|2 years|ITT population. This analysis represents those subjects with lesions in target vessels who were event free at this timepoint.||percentage of target vessels|Participants||Number
694796|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (TVR) for the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven Target Vessel Revascularization is defined as revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography)|18 months|ITT population. This analysis represents those subjects with lesions in target vessels who were event free at this timepoint||percentage of target vessels|Participants||Number
694797|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (CD-TVR) for the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven Target Vessel Revascularization is defined as revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography).|1 month and 9 months|ITT population. This analysis represents those subjects with lesions in target vessels who were event free at this timepoint||percentage of target vessels|Participants||Number
694798|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) is defined as any revascularization of the target vessel, outside of the target lesion, with or without evidence of diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target vessel).|3 years|ITT population. This analysis represents those subjects with lesions in target vessels who were event free at this time point.||percentage of target vessels|Participants||Number
694799|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) is defined as any revascularization of the target vessel, outside of the target lesion, with or without evidence of diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target vessel).|2 years|ITT population. This analysis represents those subjects with lesions in target vessels who were event free at this time point.||percentage of target vessels|Participants||Number
694800|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) is defined as any revascularization of the target vessel, outside of the target lesion, with or without evidence of diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target vessel).|18 months|ITT population. This analysis represents those subjects with lesions in target vessels who were event free at this time point.||percentage of target vessels|Participants||Number
694801|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) is defined as any revascularization of the target vessel, outside of the target lesion, with or without evidence of diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target vessel).|1 month and 9 months|ITT population. This analysis represents those subjects with lesions in target vessels who were event free at this timepoint||percentage of target vessels|Participants||Number
694802|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven TLR is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a PTA balloon or stent into a study stent, that has <50% stenosis, while treating a non-target lesion in the target vessel).|3 years|ITT population. This analysis represents those subjects with target lesions who were event free at this time point.||percentage of target lesions|Participants||Number
694803|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven TLR is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a PTA balloon or stent into a study stent, that has <50% stenosis, while treating a non-target lesion in the target vessel).|2 years|ITT population. This analysis represents those subjects with target lesions who were event free at this time point.||percentage of target lesions|Participants||Number
695480|NCT01389882|Secondary|Peak EAdi|Peak electrical activity of the diaphragm|four hours|"The analysis was per protocol. 19 patients who had completed the study was used for the analysis."||uV||Standard Deviation|Mean
694804|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven TLR is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a PTA balloon or stent into a study stent, that has <50% stenosis, while treating a non-target lesion in the target vessel).|18 months|ITT population. This analysis represents those subjects with target lesions who were event free at this time point.||percentage of target lesions|Participants||Number
694805|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)|Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a percutaneous transluminal angioplasty (PTA) balloon or stent into a study stent, that has <50% stenosis, while treating a non-target lesion in the target vessel).|1 month and 9 months|ITT population. This analysis represents those subjects with target lesions who were event free at this timepoint.||percentage of target lesions|Participants||Number
694806|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target lesion revascularization (TLR) is defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).|3 years|ITT population. This analysis represents those subjects with target lesions who were event free at this time point.||percentage of target lesions|Participants||Number
694807|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target lesion revascularization (TLR) is defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).|2 years|ITT population. This analysis represents those subjects with target lesions who were event free at this time point.||percentage of target lesions|Participants||Number
694808|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target lesion revascularization (TLR) is defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).|18 months|ITT population. This analysis represents those subjects with target lesions who were event free at this time point.||percentage of target lesions|Participants||Number
694809|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)|Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years.Target lesion revascularization (TLR) is defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by Duplex ultrasonography (DUS) or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).|1 month and 9 months|ITT population. This analysis represents those subjects with target lesions who were event free at this timepoint.||percentage of target lesions|Participants||Number
694810|NCT01396525|Secondary|Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s)|"Change in Rutherford Becker Clinical Category:
Worsening Rutherford Becker Clinical Category:
Deterioration (an increase) in the Rutherford Becker Clinical Category by at least two categories from baseline and subsequently from the earliest post-procedural measurement or to a category 5 or 6.
Improved Rutherford Becker Clinical Category:
An improvement (a decrease) in the Rutherford Becker Clinical Category of at least one category from baseline and subsequently from the earliest post-procedural measurement."|Baseline and 3 years|ITT population, per limb analysis.The number of participants analyzed includes the subjects with available follow-up data at that time-point.||percentage of target limbs|Participants||Number
694811|NCT01396525|Secondary|Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s)|"Change in Rutherford Becker Clinical Category:
Worsening Rutherford Becker Clinical Category:
Deterioration (an increase) in the Rutherford Becker Clinical Category by at least two categories from baseline and subsequently from the earliest post-procedural measurement or to a category 5 or 6.
Improved Rutherford Becker Clinical Category:
An improvement (a decrease) in the Rutherford Becker Clinical Category of at least one category from baseline and subsequently from the earliest post-procedural measurement."|Baseline and 2 years|ITT population, per limb analysis.The number of participants analyzed includes the subjects with available follow-up data at that time-point.||percentage of target limbs|Participants||Number
694812|NCT01396525|Secondary|Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s)|"Change in Rutherford Becker Clinical Category:
Worsening Rutherford Becker Clinical Category:
Deterioration (an increase) in the Rutherford Becker Clinical Category by at least two categories from baseline and subsequently from the earliest post-procedural measurement or to a category 5 or 6.
Improved Rutherford Becker Clinical Category:
An improvement (a decrease) in the Rutherford Becker Clinical Category of at least one category from baseline and subsequently from the earliest post-procedural measurement."|Between baseline and 9 months|ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||percentage of target limbs|Participants||Number
694836|NCT01396525|Secondary|Technical Success|Technical success is defined as device success (the achievement of successful delivery and deployment of the trial device(s) at the intended target lesion(s), successful withdrawal of the delivery catheter(s)), and attainment of a final residual stenosis of < 30% by QA or as reported by the investigator.|Acute: from beginning of index procedure to end of procedure|ITT population, per lesion analysis||percentage of target lesions|Participants|95% Confidence Interval|Number
700031|NCT00026221|Other Pre-specified|Toxicity|Evaluated using the National Cancer Institute (NCI) Common Toxicity Criteria version 2.0.|Continuously from the start of treatment to the end of study||||||
694813|NCT01396525|Secondary|Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s)|"Change in Rutherford Becker Clinical Category:
Worsening Rutherford Becker Clinical Category:
Deterioration (an increase) in the Rutherford Becker Clinical Category by at least two categories from baseline and subsequently from the earliest post-procedural measurement or to a category 5 or 6.
Improved Rutherford Becker Clinical Category:
An improvement (a decrease) in the Rutherford Becker Clinical Category of at least one category from baseline and subsequently from the earliest post-procedural measurement."|Between baseline and 1 month|ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||percentage of target limbs|Participants||Number
694814|NCT01396525|Secondary|Rutherford Becker Clinical Category for the Treated Limb(s)|"The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.
Category and Clinical Description:
0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable"|3 years|ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||percentage of target limbs|Participants||Number
694815|NCT01396525|Secondary|Rutherford Becker Clinical Category for the Treated Limb(s)|"The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.
Category and Clinical Description:
0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable"|2 years|ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||percentage of target limbs|Participants||Number
694816|NCT01396525|Secondary|Rutherford Becker Clinical Category for the Treated Limb(s)|"The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.
Category and Clinical Description:
0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable"|9 months|ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||percentage of target limbs|Participants||Number
694817|NCT01396525|Secondary|Rutherford Becker Clinical Category for the Treated Limb(s)|"The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.
Category and Clinical Description:
0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable"|1 month|ITT population, per limb analysis.The number of participants analyzed includes the subjects with available follow-up data at that time-point.||percentage of target limbs|Participants||Number
694818|NCT01396525|Secondary|Rutherford Becker Clinical Category for the Treated Limb(s)|"The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.
Category and Clinical Description:
0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable"|Pre-Procedure|ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||percentage of target limbs|Participants||Number
694819|NCT01396525|Secondary|Walking Impairment Questionaire Scores|Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.|3 years|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||score on a scale||Standard Deviation|Mean
694820|NCT01396525|Secondary|Walking Impairment Questionaire Scores|Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.|2 years|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||score on a scale||Standard Deviation|Mean
694821|NCT01396525|Secondary|Walking Impairment Questionaire Scores|Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.|9 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||score on a scale||Standard Deviation|Mean
695392|NCT01390857|Secondary|Number of Participants With Any Unexpected Adverse Drug Reactions|An unexpected adverse drug reaction is an adverse event whose casual relationship to the study drug is not ruled out by the reporting physician and also is not listed in a package insert of the drug.|1 month|ITT Safety Population||participants|||Number
694822|NCT01396525|Secondary|Walking Impairment Questionaire Scores|Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.|1 month|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||score on a scale||Standard Deviation|Mean
694823|NCT01396525|Secondary|Walking Impairment Questionaire Scores|Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.|Pre-procedure|ITT population, per subject analysis||score on a scale||Standard Deviation|Mean
694824|NCT01396525|Secondary|Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)|The changes in thigh brachial index is the ratio of change between the pre-procedure measure and the stated timepoint measure.|Between baseline and 3 years|ITT population, per limb analysis.The number of participants analyzed includes the subjects with available follow-up data at that time-point.||Ratio|Participants|Standard Deviation|Mean
694825|NCT01396525|Secondary|Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)|The changes in thigh brachial index is the ratio of change between the pre-procedure measure and the stated timepoint measure.|Between baseline and 2 years|ITT population, per limb analysis.The number of participants analyzed includes the subjects with available follow-up data at that time-point.||Ratio|Participants|Standard Deviation|Mean
694826|NCT01396525|Secondary|Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)|The changes in thigh brachial index is the absolute change between the pre-procedure measure and the stated timepoint measure.|Between baseline and 9 months|ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||Ratio|Participants|Standard Deviation|Mean
694827|NCT01396525|Secondary|Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)|The changes in thigh brachial index is the absolute change between the pre-procedure measure and the stated timepoint measure.|Between Baseline and 1 month|ITT population, per limb analysis.The number of participants analyzed includes the subjects with available follow-up data at that time-point.||Ratio|Participants|Standard Deviation|Mean
694828|NCT01396525|Secondary|Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)|The changes in thigh brachial index is the absolute change between the pre-procedure measure and the stated timepoint measure.|Between baseline and Post-procedure|ITT population, per limb analysis.The number of participants analyzed includes the subjects with available follow-up data at that time-point.||Ratio|Participants|Standard Deviation|Mean
694829|NCT01396525|Secondary|Thigh Brachial Index (TBI) for the Treated Limb(s)|The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.|3 years|ITT population, per limb analysis.The number of participants analyzed includes the subjects with available follow-up data at that time-point.||Ratio|Participants|Standard Deviation|Mean
694830|NCT01396525|Secondary|Thigh Brachial Index (TBI) for the Treated Limb(s)|The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.|2 years|ITT population, per limb analysis.The number of participants analyzed includes the subjects with available follow-up data at that time-point.||Ratio|Participants|Standard Deviation|Mean
694831|NCT01396525|Secondary|Thigh Brachial Index (TBI) for the Treated Limb(s)|The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.|9 months|ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||Ratio|Participants|Standard Deviation|Mean
694832|NCT01396525|Secondary|Thigh Brachial Index (TBI) for the Treated Limb(s)|The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.|1 month|ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||Ratio|Participants|Standard Deviation|Mean
694833|NCT01396525|Secondary|Thigh Brachial Index (TBI) for the Treated Limb(s)|The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.|Post-Procedure|ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||Ratio|Participants|Standard Deviation|Mean
694834|NCT01396525|Secondary|Thigh Brachial Index (TBI) for the Treated Limb(s)|The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.|Pre-procedure|ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||Ratio|Participants|Standard Deviation|Mean
694835|NCT01396525|Secondary|Procedure Success|Procedure success is defined as technical success (device success and attainment of a final residual stenosis of < 30% by QA) without complications within two (2) days after the index procedure or at hospital discharge, whichever is sooner.|Beginning of index procedure to 2 days post-index procedure or discharge, whichever is sooner|ITT population, per subject analysis||percentage of participants||95% Confidence Interval|Number
695060|NCT01393899|Secondary|Change From Baseline in Fecal Calprotectin by Week|Fecal calprotectin is an inflammatory marker for the gastrointestinal tract and considered as a measurement of neutrophil migration to the gastrointestinal tract. Higher values indicate more serious inflammation.|Weeks 8, 12 and 26|mFAS||milligrams per kilogram (mg/kg)||Standard Deviation|Mean
694837|NCT01396525|Secondary|Device Success|On a per device basis, the achievement of successful delivery and deployment of the trial device(s) at the intended location(s) and successful withdrawal of the delivery catheter(s).|Acute: from beginning of index procedure to end of procedure|ITT population, per device analysis. Included 210 stents plus 1 stent inserted but not implanted due to device malfunction, 2 stents excluded due to inappropriate sizing (stents were not implanted), 1 stent excluded as stent was not implanted per physician's choice and had no device malfunction.||percentage of devices|Participants|95% Confidence Interval|Number
694838|NCT01396525|Primary|Major Adverse Event (MAE)|Defined as death, myocardial infarction (MI), clinically-driven target lesion revascularization, and limb loss (major amputation only) on the treated side(s).|9 months|Intent to treat (ITT) population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||percentage of participants||95% Confidence Interval|Number
694839|NCT01396512|Secondary|Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine|Solicited injection site: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Loss, and Irritability. Grade 3 injection site: Pain - Cries when injected limb is moved or the movement of injected limb is reduced; Erythema and Swelling longest diameter ≥50 mm. Grade 3 systemic reactions: Fever >39.5°C; Vomiting ≥6 episodes per 24 hours or requiring parenteral hydration; Crying Abnormal - >3 hours; Drowsiness - sleeping most of the time or difficult to wake; Appetite Loss - refuses ≥3 feeds or most feeds; Irritability - inconsolable.|Day 0 up to Day 14 post-vaccination|Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set.||Participants|||Number
694840|NCT01396512|Secondary|Number of Participants With Seroprotection Against Japanese Encephalitis Chimeric Virus Before And Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine|Immunogenicity was assessed using a Japanese encephalitis chimeric virus (JE-CV) PRNT50 assay. Seroprotection was defined as the percentage of participants with a titer ≥10 (1/dil) at pre-vaccination and at Day 28 post-vaccination.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Seroprotection against JE-CV was assessed in the Per-Protocol Analysis Set.||Participants|||Number
694841|NCT01396512|Secondary|Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus Before And Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine|"Geometric mean titers were assessed using a Japanese encephalitis chimeric virus (JE-CV) 50% Plaque Reduction Neutralization Test (PRNT50).
JE-CV PRNT50 antibody titer >10 (1/dil, Day 0)"|Day 0 (pre-vaccination) and Day 28 post-vaccination|Geometric mean titers against the JE-CV was assessed in the Per-Protocol Analysis Set.||Titers||95% Confidence Interval|Geometric Mean
694842|NCT01396512|Primary|Percentage of Participants With Seroconversion to Japanese Encephalitis Chimeric Virus Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine|Immunogenicity assessed using a Japanese encephalitis chimeric virus (JE-CV) 50% Plaque Reduction Neutralization Test (PRNT50). Seroconversion was defined as the percentage of participants who developed neutralizing antibody titers above 10 (1/dil) when seronegative at baseline (<1/10) or who presented a ≥4-fold rise in their neutralizing antibody titers when seropositive (≥1/10) at baseline.|Day 28 post-vaccination|Seroconversion to JE-CV was assessed in the Per-Protocol Analysis Set.||Percentage of Participants|||Number
694843|NCT01396434|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to 13vPnC were reported. An AE was any untoward medical occurrence in a participant who received 13vPnC. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-SAEs.|Baseline through and including 28 calendar days after the last administration of study vaccine within the observation period|Participants who received at least 1 dose of 13vPnC.||participants|||Number
694844|NCT01396421|Secondary|Change From Baseline to Week 6 in PANSS Marder Anxiety Depression Score|The PANSS Marder Factor score - Anxiety/Depression Score consists of 4 PANSS items (anxiety [G2], guilt feelings [G3], tension [G4], depression [G6]). The PANSS Marder Factor score - Anxiety/Depression Score for participants was calculated as the sum of the rating assigned to each of the 4 items, and ranged from 4 to 28 with a higher score indicating greater severity of symptoms.|Baseline to Week 6|Efficacy: consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. At Week 6, 121, 123, 56 and 108 participants in the Brex 4mg, Brex 2mg, Brex 0.25 mg and placebo group, respectively had data.||Units on a scale||Standard Error|Least Squares Mean
694845|NCT01396421|Secondary|Change From Baseline to Week 6 in PANSS Marder Uncontrolled Hostility/Excitement Score|The PANSS Marder Factor score - Uncontrolled Hostility/Excitement Score consists of 4 PANSS items (excitement [P4], hostility [P7], uncooperativeness [G8], poor impulse control [G14]). The PANSS Marder Factor score - Uncontrolled Hostility/Excitement Score for participants was calculated as the sum of the rating assigned to each of the 4 items, and ranged from 4 to 28 with a higher score indicating greater severity of symptoms.|Baseline to Week 6|Efficacy: consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. At Week 6, 121, 123, 56 and 108 participants in the Brex 4mg, Brex 2mg, Brex 0.25 mg and placebo group, respectively had data.||Units on a scale||Standard Error|Least Squares Mean
694846|NCT01396421|Secondary|Change From Baseline to Week 6 in PANSS Marder Disorganised Thought Score|The PANSS Marder Factor score -Disorganized Thought Score consists of 7 PANSS items (conceptual disorganization [P2], difficulty in abstract thinking [N5], mannerisms and posturing [G5], disorientation [G10], poor attention [G11], disturbance of violation [G13], preoccupation [G15]). The PANSS Marder Factor score - Disorganized Thought Score for participants was calculated as the sum of the rating assigned to each of the 7 items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms.|Baseline to Week 6|Efficacy: consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. At Week 6, 121, 123, 56 and 108 participants in the Brex 4mg, Brex 2mg, Brex 0.25 mg and placebo group, respectively had data.||Units on a scale||Standard Error|Least Squares Mean
700131|NCT00036738|Secondary|Transplant-related Mortality|Number of patients with TRM within one year post-transplant.|At 1 year|||Participants|||Count of Participants
694847|NCT01396421|Secondary|Change From Baseline to Week 6 in PANSS Marder Factor Score - Negative Symptoms Score|The PANSS Marder Factor score - Negative Symptoms Score consists of 7 PANSS items (blunted effect [N1], emotional withdrawal [N2], poor rapport [N3], passive/apathetic social withdrawal [N4], lack of spontaneity and conversation flow [N6], motor retardation [G7], active social avoidance [G16]). The PANSS Marder Factor score - Negative Symptoms Score for participants was calculated as the sum of the rating assigned to each of the 7 items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms.|Baseline to Week 6|Efficacy: consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. At Week 6, 121, 123, 56 and 108 participants in the Brex 4mg, Brex 2mg, Brex 0.25 mg and placebo group, respectively had data.||Units on a scale||Standard Error|Least Squares Mean
694848|NCT01396421|Secondary|Change From Baseline to Week 6 in PANSS Marder Factor Score - Positive Symptoms Score|The PANSS Marder Factor score - Positive Symptoms Score consists of 8 PANSS items (delusions [P1], hallucinatory behaviour [P3], grandiosity [P5], suspiciousness [P6], stereotyped thinking [N7], somatic concern [G1], unusual thought content [G9], lack of judgment and insight [G10]. Each was rated on a scale of 1 (absent) to 7 (extreme). The PANSS Marder Factor score - Positive Symptoms Score for participants was calculated as the sum of the rating assigned to each of the 8 items, and ranged from 8 to 42 with a higher score indicating greater severity of symptoms.|Baseline to Week 6|Efficacy: consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. At Week 6, 121, 123, 56 and 108 participants in the Brex 4mg, Brex 2mg, Brex 0.25 mg and placebo group, respectively had data.||Units on a scale||Standard Error|Least Squares Mean
694849|NCT01396421|Secondary|Discontinuation Rate for Lack of Efficacy at Week 6||Week 6|Efficacy: consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation.||Percentage of participants|||Number
694850|NCT01396421|Secondary|Mean Change From Baseline to Week 6 in PANSS Excited Component (PEC) Score|The PEC consists of 5 PANSS items (excitement [P4], hostility [P7], tension [G4], uncooperativeness [G8], and poor impulse control [G14]). Each rated on a scale of 1 (absent) to 7 (extreme). The PEC for participants was calculated as the sum of the rating assigned to each of the 5 items, and ranged from 5 to 35 with a higher score indicating greater severity of symptoms.|Baseline to Week 6|Efficacy: consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. At Week 6, 121, 123, 56 and 108 participants in the Brex 4mg, Brex 2mg, Brex 0.25 mg and placebo group, respectively had data.||Units on a scale||Standard Error|Least Squares Mean
694851|NCT01396421|Secondary|Response Rate at Week 6|Response rate was defined as improvement in mean change of ≥30% from baseline in PANSS Total Score at Week 6 or CGI-I score of 1 (very much improved) or 2 (much improved) at Week 6.|Week 6|Efficacy: consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation.||Percentage of participants|||Number
694852|NCT01396421|Secondary|Clinical Global Impression- Improvement Scale (CGI-I) Score at Week 6|The participant’s overall improvement was rated using the CGI-I. The rater or study physician rated the participant’s total improvement whether or not it was due entirely to drug treatment. All responses were compared with the participant’s condition at screening/baseline. Response choices were: 0=not assessed, 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse.|Week 6|Efficacy: consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation.||Units on a scale||Standard Deviation|Mean
694853|NCT01396421|Secondary|Mean Change From Baseline to Week 6 in PANSS Negative Subscale Score|For each symptom construct of the PANSS Negative Subscale, severity was rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. The symptom constructs were as follows: blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS Negative Subscale Score for each participant was calculated as the sum of the rating assigned to each of the 7 subscale items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms.|Baseline to Week 6|Efficacy: consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. At Week 6, 121, 123, 56 and 108 participants in the Brex 4mg, Brex 2mg, Brex 0.25 mg and placebo group, respectively had data.||Units on a scale||Standard Error|Least Squares Mean
694854|NCT01396421|Secondary|Mean Change From Baseline to Week 6 in PANSS Positive Subscale Score|For each symptom construct of the PANSS Positive Subscale, severity was rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. The symptom constructs were as follows: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS Positive Subscale Score for each participant was calculated as the sum of the rating assigned to each of the 7 subscale items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms.|Baseline to Week 6|Efficacy: consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. At Week 6, 121, 123, 56 and 108 participants in the Brex 4mg, Brex 2mg, Brex 0.25 mg and placebo group, respectively had data.||Units on a scale||Standard Error|Least Squares Mean
694855|NCT01396421|Secondary|Mean Change From Baseline to Week 6 in Personal and Social Performance Scale (PSP)|The PSP is a clinician-rated scale that measures personal and social functioning in 4 domains: socially useful activities (eg, work and study), personal and social relationships, self-care, and disturbing and aggressive behaviors. Impairment in each of these domains was rated as absent, mild, manifest, marked, severe, or very severe. These ratings were then converted to a total score based on a 100-point scale using algorithms to identify the appropriate 10-point interval, and the rater’s judgment to determine the total score within the 10-point interval. Participants with a PSP total score of 71 to 100 were considered to have mild functional difficulty. Scores of 31 to 70 represented manifest disabilities of various degrees and ratings of 1 to 30 indicated minimal functioning that required intense support and/or supervision.|Baseline to Week 6|Efficacy: consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. At Week 6, 121, 122, 55 and 108 participants in the Brex 4mg, Brex 2mg, Brex 0.25 mg and placebo group, respectively had data.||Units on a scale||Standard Error|Least Squares Mean
694856|NCT01396421|Secondary|Mean Change From Baseline to Week 1, 2, 3, 4 and 5 in Clinical Global Impression - Severity of Illness Scale (CGI-S) Score.|The severity of illness was rated using the CGI-S. To perform this assessment, the rater or study physician answered the following question: “Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?” Response choices included: 0=not assessed; 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; and 7=among the most extremely ill participant.|Baseline to Week 1, 2, 3, 4 and 5|Efficacy: consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation.||Units on a scale||Standard Error|Least Squares Mean
694857|NCT01396421|Secondary|Mean Change From Baseline to Week 1, 2, 3, 4 and 5 Positive and Negative Syndrome Scale (PANSS) Total Score.|The PANSS consists of 3 subscales (positive subscale, negative subscale and general psychology subscale) containing a total of 30 symptom constructs and was administered using the Structured Clinical Interview (SCI)-PANSS. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline to Week 1, 2, 3, 4, 5|Efficacy: consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation.||Units on a scale||Standard Error|Least Squares Mean
694858|NCT01396421|Secondary|Mean Change From Baseline to Week 6 in Clinical Global Impression - Severity of Illness Scale (CGI-S) Score.|The severity of illness was rated using the CGI-S which is the key secondary endpoint. To perform this assessment, the rater or study physician answered the following question: “Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?” Response choices included: 0=not assessed; 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; and 7=among the most extremely ill participant.|Baseline to Week 6|Efficacy: consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. At Week 6, 121, 124, 56 and 109 participants in the Brex 4mg, Brex 2mg, Brex 0.25 mg and placebo group, respectively had data.||Units on a scale||Standard Error|Least Squares Mean
694859|NCT01396421|Primary|Mean Change From Baseline to Week 6 Positive and Negative Syndrome Scale (PANSS) Total Score.|The PANSS consists of 3 subscales (positive subscale, negative subscale and general psychology subscale) containing a total of 30 symptom constructs and was administered using the Structured Clinical Interview (SCI)-PANSS. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline to Week 6|Efficacy: consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. At Week 6, 134, 132, 62 and 124 participants in the Brex 4mg, Brex 2mg, Brex 0.25 mg and placebo group, respectively had data.||Units on a scale||Standard Error|Least Squares Mean
694860|NCT01396395|Secondary|Number of Subjects Who Showed Compliance to Nicorandil|Compliance percent (%) was calculated by using the formula: (actual total dose divided by planned total dose) multiplied by 100. If subject compliance was less than 80% or greater than 120%, then that subject was considered as non compliant. The compliance of subjects taking nicorandil was evaluated.|Baseline up to 12 Weeks|Safety analysis population included all the subjects who received at least one dose of the study drug. 4 subjects randomized to standard+nicorandil group were included in standard group for safety analysis as they did not receive nicorandil. 1 subject randomized to standard group was included in standard+nicorandil group as nicorandil was received.||subjects|||Number
694861|NCT01396395|Secondary|Number of Subjects With Any Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Death, and AEs Leading to Discontinuation|An AE was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. SAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs were defined as the AEs that occurred between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|From the first dose of study drug administration up to 30 days after the last dose of study drug administration (up to 16 weeks )|Safety analysis population included all the subjects who received at least one dose of the study drug. 4 subjects randomized to standard+nicorandil group were included in standard group for safety analysis as they did not receive nicorandil. 1 subject randomized to standard group was included in standard+nicorandil group as nicorandil was received.||subjects|||Number
694862|NCT01396395|Secondary|Walk Distance in Six Minute Walk (6-MWT) Test at Week 12|The 6-MWT distance was the distance that a subject could walk in 6 minutes. Subjects were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. The 6-MWT was completed within 1-hour after wearing Holter.|At Week 12|FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies number of subjects evaluable for this outcome measure.||meters||Standard Deviation|Mean
694863|NCT01396395|Secondary|Number of Nitroglycerin Tablets Consumed in a Week||At Week 12|FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure.||tablets per week||Inter-Quartile Range|Median
694864|NCT01396395|Secondary|Number of Subjects Relieved From Angina Attack After the Consumption of Nitroglycerin||At Week 12|FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure.||subjects|||Number
694865|NCT01396395|Secondary|Frequency of Angina Attack|The total number of times angina attacks occurred within a week (number of times/week)|At Week 12|FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure.||angina attacks per week||Inter-Quartile Range|Median
694866|NCT01396395|Secondary|Number of Subjects Experienced Angina Attack||Baseline up to 12 Weeks|FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure.||subjects|||Number
694867|NCT01396395|Secondary|ECG QT Dispersion|The ECG QT dispersion was defined as the difference between the longest (QTmax) and the shortest (QTmin) QT intervals within a 12‐lead ECG.|At Week 12|FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure.||milliseconds||Standard Deviation|Mean
694868|NCT01396395|Secondary|Number of Arrhythmia Occurred Within 24 Hours|The number of ventricular tachycardia and premature ventricular beats that occurred within 24 hours.|At Week 12|FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure.||beats per 24 hours||Standard Deviation|Mean
694869|NCT01396395|Secondary|Heart Rate Variability (HRV) Rate: Frequency Domain Power-24 Hour|HRV is the degree of fluctuation in the length of the intervals between heart beats. All HRV parameters are calculated on ‘normal-to-normal’ (NN) inter-beat intervals (or NN intervals) caused by normal heart contractions. The HRV was evaluated based on frequency domain power-24 hours.|At Week 12|FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure.||millisecond square (ms^2)||Standard Deviation|Mean
694870|NCT01396395|Secondary|Heart Rate Variability (HRV) Rate: Time Domain|HRV is the degree of fluctuation in the length of the intervals between heart beats. All HRV parameters are calculated on ‘normal-to-normal’ (NN) inter-beat intervals (or NN intervals) caused by normal heart contractions. Standard deviation of all NN intervals (SDNN) and Standard deviation of the averages of NN intervals (SDANN) are the two time domain methods used to determine heart rate variability. Two variants of the SDNN, created by dividing the 24-hour monitoring period into 5-minute segments, are the SDNN index and the SDANN index. The SDNN index is the mean of all the 5-minute standard deviations of NN (normal RR) intervals during the 24-hour period, while the SDANN index is the standard deviation of all the 5-minute NN interval means.|At Week 12|"FAS included all randomized subjects who received at least one dose of study treatment. n signifies the number of subjects evaluable for each category in each group for this outcome measure, respectively."||millisecond||Standard Deviation|Mean
694871|NCT01396395|Secondary|Percentage of Subjects Experienced Ischemic Heart Attack During the Six-minute Walk Test|The percentage of subjects who experienced ischemic heart attack during the Six-minute walk test (6-MWT) were evaluated.The 6-MWT was the distance that a subject could walk in 6 minutes. Subjects were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. The 6-MWT was completed within 1-hour after wearing Holter.|At Week 12|FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure. Analysis was done only for subjects with myocardial ischemia attack.||percentage of subjects|||Number
694872|NCT01396395|Secondary|Change From Baseline in Longest Duration of ST Segment Depression at Week 12|The maximum ST- depression was evaluated from sum of all leads for all the subjects with myocardial ischemia attack. The longest duration of ST segment depression of all leads for all the subjects with myocardial ischemia attack.|Baseline, Week 12|FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure. Analysis was done only for subjects with myocardial ischemia attack.||seconds||Standard Deviation|Mean
694873|NCT01396395|Secondary|Change From Baseline in Maximum ST-depression at Week 12|The maximum ST- depression was evaluated from sum of all leads for all the subjects with myocardial ischemia attack. Absolute value of maximum ST-depression was used for calculation.|Baseline, Week 12|FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure. Analysis was done only for subjects with myocardial ischemia attack.||millimeter||Standard Deviation|Mean
694874|NCT01396395|Secondary|Change From Baseline in Total Myocardial Ischemic Burden at Week 12|The total myocardial ischemic burden was defined as the product of the decrease, total array and total time of ST-segment in symptomatic and asymptomatic myocardial ischemia subjects within 24 hours.|Baseline, Week 12|FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure. Analysis was done only for subjects with myocardial ischemia attack.||millimeter*minutes||Standard Deviation|Mean
694875|NCT01396395|Primary|Number of Myocardial Ischemia Attacks in 24 Hours|Myocardial ischemia attack was evaluated by 24-hour Holter monitoring based on the following criteria: 0.08 seconds after the J point in electrocardiogram (ECG) or compared with baseline levels, ST-segment with horizontal or downward sloping down greater than or equal to (>=) 0.1 millivolts (mV), and lasted for >= 1 minute, and at least 1 minute of interval with another ischemic attack, as one array myocardial ischemia.|At Week 12|FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure.||ischemic attacks per 24 hours||Standard Deviation|Mean
694876|NCT01396382|Primary|Number of Patients That Experienced a Change in Care Plans After 68GA-DOTATATE PET Scan|Determine if the 68Ga-DOTATATE PET scan changes patient care plans compared to conventional imaging/diagnostic techniques (Octreoscan, MRI, CT, U/S).|at 1 year|A major change in management is defined as:planned surgery cancelled, added, or a different type of surgery was planned, or a medication was added or stopped, or a new treatment modality (e.g. radiation) was added. A minor change was adjustment to planned surgery or radiation field, or in current medication dosage.||participants|||Number
694877|NCT01396382|Secondary|Number of Severe Adverse Events Occurences Resulting in Changes to Patient Treatment Plans, as a Measure of Safety and Tolerability|Determine if any adverse effects are associated with the 68Ga-DOTATATE PET scan and the number of patients that experience them using NCI Common Terminology Criteria for Adverse Events v4.0, where: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life‐threatening; Grade 5, death. Toxicities present at baseline and continuing without change in grade were excluded for assessment of this outcome measure.|at 1 year|||participants|||Number
694936|NCT01396083|Secondary|Changes in the Quality of Life According to the Short Form (36) Health Survey (SF-36)Questionnaires|SF-36 summary measures are norm-based scores with mean = 50 and SD = 10. Higher scores indicate better health|Baseline, month 6|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. observed is only described in this analysis.||Units on a scale||Standard Deviation|Mean
694878|NCT01396265|Secondary|Apparent Volume of Distribution During the Terminal Phase lambda_z Following an Extravascular Dose (V_z/F)|V_z/F represents the apparent volume of distribution during the terminal phase λz following an extravascular dose|0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose|PK analysis set - all subjects of the treated set who provided at least 1 observation for at least 1 primary PK endpoint in any trial period without important protocol violations relevant to the evaluation for PL, and who did not experience vomiting at or before 2 times median tmax for afatinib.||Litres||Geometric Coefficient of Variation|Geometric Mean
694879|NCT01396265|Secondary|Apparent Clearance of Afatinib in the Plasma After Extravascular Administration (CL/F)|CL/F represents the apparent clearance of the analyte in the plasma after extravascular administration|0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose|PK analysis set - all subjects of the treated set who provided at least 1 observation for at least 1 primary PK endpoint in any trial period without important protocol violations relevant to the evaluation for PL, and who did not experience vomiting at or before 2 times median tmax for afatinib.||mL/min||Geometric Coefficient of Variation|Geometric Mean
694880|NCT01396265|Secondary|Mean Residence Time of Afatinib in the Body After Oral Administration (MRTpo)|MRTpo represents the mean residence time of the analyte in the body after oral administration|0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose|PK analysis set - all subjects of the treated set who provided at least 1 observation for at least 1 primary PK endpoint in any trial period without important protocol violations relevant to the evaluation for PL, and who did not experience vomiting at or before 2 times median tmax for afatinib.||hours||Geometric Coefficient of Variation|Geometric Mean
694881|NCT01396265|Secondary|Percentage of the AUCtz-∞ Obtained by Extrapolation (%AUCtz-∞)|%AUCtz-∞ represents the percentage of the AUCtz-∞ obtained by extrapolation|0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose|PK analysis set - all subjects of the treated set who provided at least 1 observation for at least 1 primary PK endpoint in any trial period without important protocol violations relevant to the evaluation for PL, and who did not experience vomiting at or before 2 times median tmax for afatinib.||percentage of AUCtz-∞||Geometric Coefficient of Variation|Geometric Mean
694882|NCT01396265|Secondary|Area Under Curve From 0 to 24 h (AUC0-24)|AUC0-24 represents the area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 hours (h)|0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose|PK analysis set - all subjects of the treated set who provided at least 1 observation for at least 1 primary PK endpoint in any trial period without important protocol violations relevant to the evaluation for PL, and who did not experience vomiting at or before 2 times median tmax for afatinib.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
694883|NCT01396265|Secondary|Terminal Half-life of Afatinib in Plasma (t1/2)|t1/2 represents the terminal half-life of the analyte in plasma|0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose|PK analysis set - all subjects of the treated set who provided at least 1 observation for at least 1 primary PK endpoint in any trial period without important protocol violations relevant to the evaluation for PL, and who did not experience vomiting at or before 2 times median tmax for afatinib.||hours||Geometric Coefficient of Variation|Geometric Mean
694884|NCT01396265|Secondary|Time From Dosing to the Maximum Concentration of Afatinib in Plasma (Tmax)|tmax represents the time from dosing to the maximum concentration of the analyte in plasma|0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose|PK analysis set - all subjects of the treated set who provided at least 1 observation for at least 1 primary PK endpoint in any trial period without important protocol violations relevant to the evaluation for PL, and who did not experience vomiting at or before 2 times median tmax for afatinib.||hours||Full Range|Median
694885|NCT01396265|Primary|Maximum Concentration (Cmax)|Cmax represents the maximum concentration of the analyte in plasma.|0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose|PK analysis set - all subjects of the treated set who provided at least 1 observation for at least 1 primary PK endpoint in any trial period without important protocol violations relevant to the evaluation for PL, and who did not experience vomiting at or before 2 times median tmax for afatinib.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
694886|NCT01396265|Primary|Area Under Curve From 0 to tz (AUC0-tz)|AUC0-tz represents the area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable drug plasma concentration.|0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose|PK analysis set - all subjects of the treated set who provided at least 1 observation for at least 1 primary PK endpoint in any trial period without important protocol violations relevant to the evaluation for PL, and who did not experience vomiting at or before 2 times median tmax for afatinib.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
694887|NCT01396265|Primary|Area Under Curve From 0 to Infinity Hours (AUC0-∞)|AUC0-∞ represents the area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity.|0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose|PK analysis set - all subjects of the treated set who provided at least 1 observation for at least 1 primary PK endpoint in any trial period without important protocol violations relevant to the evaluation for PL, and who did not experience vomiting at or before 2 times median tmax for afatinib.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
694888|NCT01396239|Post-Hoc|Frequency of AEs Related to Eteplirsen|Frequency of AEs that the study physician considered to be any of the following: Related; Possibly related; or Probably related to eteplirsen.|24 Weeks|||Number of patients|||Number
694889|NCT01396239|Post-Hoc|Adverse Events >30%|Adverse events that occurred in >30% of the overall patient population across treatment arms.|24 Weeks|||Number of patients|||Number
694890|NCT01396239|Secondary|Change From Baseline: 6 Minute Walk Test (6MWT) - Modified Intent to Treat Population (mITT)|A key secondary efficacy endpoint will be based on the pre-treatment and post-treatment of the 6-MWT distance. Change from baseline: 6 Minute Walk Test (6MWT) - modified Intent-to-Treat population (mITT).|24 weeks|The mITT population excludes 2 patients in the 30mg/kg arm who showed rapid disease progression within weeks of enrollment, and were unable to complete assessments that required ambulation at or beyond Week 24.||Meters||Standard Error|Mean
694891|NCT01396239|Secondary|Change From Baseline: 6 Minute Walk Test (6MWT) - Intent to Treat Population (ITT)|A key secondary efficacy endpoint will be based on the pre-treatment and post-treatment Change from baseline: 6 Minute Walk Test (6MWT) - Intent to Treat population (ITT)|24 weeks|||Meters||Standard Error|Mean
694892|NCT01396239|Primary|Change in the Number (%) of Dystrophin Positive Fibers|The primary efficacy endpoint will be based on the pre-treatment and post-treatment change in the number (%) of dystrophin positive fibers as measured in the muscle biopsy tissue on immunohistochemistry (IHC).|After 12 weeks for 4 patients who received 50 mg/kg and 2 patients who received placebo. After 24 weeks for 4 patients who received 30 mg/kg and 2 patients who received placebo.|The sample size for the study was selected based on Proof of Principal approach.||percentage of dystrophin Pos. fibers||Full Range|Least Squares Mean
694893|NCT01396226|Secondary|Paced QT Interval|Change in CS Paced QT interval (P600 MS) from before and after IP infusion during electrophysiological measurements|Baseline to last assessment during IP infusion|PP||msec||Standard Deviation|Mean
694894|NCT01396226|Secondary|Ventricular Effective Refractory Period|Change in VERP from before IP infusion to 1st and 2nd assessments during IP infusion|Baseline to last assessment during IP infusion|PP||msec||Standard Deviation|Mean
694895|NCT01396226|Primary|Left Atrial Effective Refractory Period|Change in LAERP from before IP infusion to 1st and 2nd assessments during IP infusion|Baseline to last assessment during IP infusion|Per Protocol (PP)||msec||Standard Deviation|Mean
694896|NCT01396226|Secondary|RR Interval|Change from observation before IP infusion to 6 to 8 hours and 20 to 24 hours after IP infusion|Baseline to last assessment during IP infusion|FAS||msec||Standard Deviation|Mean
694897|NCT01396226|Secondary|QRS Duration|Change from observation before IP infusion to 6 to 8 hours and 20 to 24 hours after IP infusion|Baseline to last assessment during IP infusion|FAS||msec||Standard Deviation|Mean
694898|NCT01396226|Secondary|PR Interval|Interval from the onset of the P-wave to the start of the QRS complex. Change from observation before IP infusion to 6 to 8 hours and 20 to 24 hours after IP infusion|Baseline to last assessment during IP infusion|FAS||msec||Standard Deviation|Mean
694899|NCT01396226|Secondary|HV Interval|Change from observation before IP infusion to 30 mins after IP start. HV interval - represents conduction time from the proximal His bundle to the ventricular myocardium, ie, infra-nodal conduction time.|Baseline to last assessment during IP infusion|FAS||msec||Standard Deviation|Mean
694900|NCT01396226|Secondary|AH Interval|Change from observation before IP infusion to 30 mins after IP start. AH interval- the conduction time from the low right atrium at the inter-atrial septum through the AV node to the His bundle, ie, intra-nodal conduction time.|Baseline to last assessment during IP infusion|FAS||msec||Standard Deviation|Mean
694901|NCT01396226|Secondary|PA Interval|Reflects intra-atrial conduction and is defined as the interval from the onset of the P wave in the surface ECG to the onset of atrial activation (A) in the His bundle electrogram. Change from observation before IP infusion to 30 min after IP start|Baseline to last assessment during IP infusion|FAS||msec||Standard Deviation|Mean
694902|NCT01396226|Secondary|Atrio-ventricular Effective Refractory Period|Change from observation before IP infusion to during 1st and 2nd LAERP Mean|Baseline to last assessment during IP infusion|FAS||msec||Standard Deviation|Mean
694903|NCT01396226|Secondary|Paced QT Interval|Change in CS Paced QT interval (P600 MS) from before and after IP infusion during electrophysiological measurements|Baseline to last assessment during IP infusion|FAS||msec||Standard Deviation|Mean
694904|NCT01396226|Secondary|Ventricular Effective Refractory Period|Change in VERP from before IP infusion to 1st and 2nd assessments during IP infusion|Baseline to last assessment during IP infusion|FAS||msec||Standard Deviation|Mean
694905|NCT01396226|Primary|Left Atrial Effective Refractory Period|Change in LAERP from before IP infusion to 1st and 2nd assessments during IP infusion|Baseline to last assessment during IP infusion|Full A analysis Set (FAS)||msec||Standard Deviation|Mean
694906|NCT01396187|Secondary|Average Plasma Concentration (Cav) of PF-05231023 at Steady State|Participants who received PF-05231023 with C-terminal and N-terminal Cmax at steady state were reported.|0 hour (pre-dose) 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 25; Day 26, 29|PK parameter analysis set included all enrolled and treated participants who had at least 1 of the PK parameters of interest. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||ng/mL||Standard Deviation|Geometric Mean
694907|NCT01396187|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) of PF-05231023 at Steady State|Participants who received PF 05231023 with C-terminal and N-terminal Cmax at steady state were reported.|0 hour (pre-dose) 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 25; Day 26, 29|PK parameter analysis set included all enrolled and treated participants who had at least 1 of the PK parameters of interest. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||ng/mL||Standard Deviation|Geometric Mean
694908|NCT01396187|Secondary|Volume of Distribution of PF-05231023 at Steady State (Vss)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vss is the apparent volume of distribution at steady-state. PF-05231023 with C-terminal and N-terminal Vss at steady state were reported.|0 hour (pre-dose) 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 25; Day 26, 29|"PK parameter analysis set included all enrolled and treated participants who had at least 1 of the PK parameters of interest. n signifies those participants who were evaluated for this measure at the specified terminal for each arm."||liter||Standard Deviation|Geometric Mean
694909|NCT01396187|Secondary|Apparent Clearance (CL) of PF-05231023 at Steady State|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. Participants who received PF-05231023 with C-terminal and N-terminal CL at steady state were reported.|0 hour (pre-dose) 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 25; Day 26, 29|PK parameter analysis set included all enrolled and treated participants who had at least 1 of the PK parameters of interest. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||liter per hour||Standard Deviation|Geometric Mean
694910|NCT01396187|Secondary|Plasma Terminal Half-Life (t1/2) of PF-05231023 at Steady State|Plasma terminal half-life is the time measured for the plasma concentration to decrease by one half at the terminal phase. Participants who received PF-05231023 with C-terminal and N-terminal t1/2 at steady state were reported.|0 hour (pre-dose) 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 25; Day 26, 29|"PK parameter analysis set included all enrolled and treated participants who had at least 1 of the PK parameters of interest. n signifies those participants who were evaluated for this measure at the specified terminal for each arm."||hour||Standard Deviation|Mean
694911|NCT01396187|Secondary|Accumulation Ratio for Maximum Observed Plasma Concentration (Rac,Cmax) of PF- 05231023|Accumulation ratio based on maximum plasma concentration (Cmax) was calculated as: Rac,Cmax = Cmax at steady state (Day 25) divided by Cmax at first dose (Day 1). Participants who received PF-05231023 with C-terminal and N-terminal Rac,Cmax at steady state were reported.|0 hour (pre-dose) on Day 1, 4, 25; 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 1, 25; Day 2, 3, 26, 29|PK parameter analysis set included all enrolled and treated participants who had at least 1 of the PK parameters of interest. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||ratio||Standard Deviation|Geometric Mean
694912|NCT01396187|Secondary|Accumulation Ratio for Area Under the Curve From Time Zero to End of Dosing Interval of PF-05231023 (Rac)|Rac was obtained from AUCtau at steady state (Day 25) divided by AUCtau after single dose (Day 1). AUCtau was the area under the concentration-time profile from time zero to end of dosing interval, where tau = 72 hours for Day 1 and tau = 96 hours for Day 25. Participants who received PF-05231023 with C-terminal and N-terminal Rac at steady state were reported.|0 hour (pre-dose) on Day 1, 4, 25; 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 1, 25; Day 2, 3, 26, 29|PK parameter analysis set included all enrolled and treated participants who had at least 1 of the PK parameters of interest. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||ratio||Standard Deviation|Geometric Mean
694913|NCT01396187|Secondary|Maximum Observed Plasma Concentration (Cmax) of PF-05231023 at Steady State|Participants who received PF 05231023 with C-terminal and N-terminal Cmax at steady state were reported.|0 hour (pre-dose) 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 25; Day 26, 29|PK parameter analysis set included all enrolled and treated participants who had at least 1 of the PK parameters of interest. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||ng/mL||Standard Deviation|Geometric Mean
694914|NCT01396187|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05231023 at Steady State|Participants who received PF-05231023 with C-terminal and N-terminal Tmax at steady state were reported.|0 hour (pre-dose) 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 25; Day 26, 29|PK parameter analysis set included all enrolled and treated participants who had at least 1 of the PK parameters of interest. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||hour||Full Range|Median
694915|NCT01396187|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-05231023 at Steady State|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) at steady state. Participants who received PF-05231023 with C-terminal and N-terminal AUClast at steady state were reported.|0 hour (pre-dose) 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 25; Day 26, 29|PK parameter analysis set included all enrolled and treated participants who had at least 1 of the PK parameters of interest. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||ng*hr/mL||Standard Deviation|Geometric Mean
694916|NCT01396187|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-05231023 at Steady State|Participants who received PF-05231023 with C-terminal and N-terminal AUCtau at steady state were reported.|0 hour (pre-dose) 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 25; Day 26, 29|PK parameter analysis set included all enrolled and treated participants who had at least 1 of the PK parameters of interest. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||ng*hr/mL||Standard Deviation|Geometric Mean
694917|NCT01396187|Secondary|Maximum Observed Plasma Concentration (Cmax) of PF-05231023 After Single Dose|Participants who received PF 05231023 with C-terminal and N-terminal Cmax were reported.|0 hour (pre-dose) on Day 1, 4; 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 1; Day 2, 3|PK parameter analysis set included all enrolled and treated participants who had at least 1 of the PK parameters of interest.||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
694918|NCT01396187|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05231023 After Single Dose|Participants who received PF-05231023 with C-terminal and N-terminal Tmax were reported.|0 hour (pre-dose) on Day 1, 4; 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 1; Day 2, 3|PK parameter analysis set included all enrolled and treated participants who had at least 1 of the PK parameters of interest.||hour||Full Range|Median
694919|NCT01396187|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-05231023 After Single Dose|Participants who received PF-05231023 with C-terminal and N-terminal AUCtau were reported.|0 hour (pre-dose) on Day 1, 4; 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 1; Day 2, 3|Pharmacokinetic (PK) parameter analysis set included all enrolled and treated participants who had at least 1 of the PK parameters of interest.||nanogram*hour per milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
694920|NCT01396187|Primary|Number of Participants With Blood Glucose Abnormalities|Criteria for blood glucose abnormality: Blood glucose levels <0.6* LLN or >1.5* ULN.|Baseline up to Day 32|Safety population included all participants who received at least 1 dose of study medication.||participants|||Number
694921|NCT01396187|Primary|Number of Participants With Electrocardiogram (ECG) Abnormalities|Criteria for potential clinical concern in ECG parameters: maximum PR interval of greater than or equal to (>=) 300 milliseconds (msec), maximum QRS interval >=140 msec, maximum QTCF interval (Fridericia’s Correction) of 450 to <480 msec, 480 to <500 msec and >=500 msec, maximum increase of >=25 percent (%) for baseline value of >200 msec and >=50% for baseline value of less than or equal to (<=) 200 msec for PR interval, maximum increase from baseline of >=50% for QRS interval, maximum increase from baseline of >=30 msec to <60 msec and maximum increase from baseline of >60 msec in QTCF interval (Fridericia’s Correction).|Baseline up to Day 77|Safety population included all participants who received at least 1 dose of study medication.||participants|||Number
694922|NCT01396187|Primary|Number of Participants With Vital Signs Abnormalities|Criteria for vital signs abnormalities: supine systolic blood pressure (SBP) <90 millimeter of mercury (mm Hg), supine diastolic BP (DBP) <50 mm Hg, supine pulse rate <40 beats per minute (bpm), > 120 bpm. Maximum increase or decrease from baseline in supine SBP >=30 mm Hg and maximum increase or decrease from baseline in supine DBP >=20 mm Hg.|Baseline up to Day 77|Safety population included all participants who received at least 1 dose of study medication.||participants|||Number
694923|NCT01396187|Primary|Number of Participants With Abnormal Laboratory Values|Criteria for laboratory tests abnormalities included: hemoglobin, hematocrit and red blood cells (RBCs)(less than [<] 0.8*lower limit of normal[LLN]); leucocytes (<0.6/greater than [>]1.5*upper limit of normal [ULN]); platelets (<0.5*LLN></0>1.75*ULN); neutrophils, lymphocytes (<0.8*LLN></0>1.2*ULN); eosinophils, basophils, monocytes (>1.2*ULN); total bilirubin, direct bilirubin, indirect bilirubin (>1.5*ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (>3*ULN), total protein, albumin (<0.8*LLN></0>1.2*ULN); creatinine, urea (>1.3*ULN); glucose (<0.6*LLN></0>1.5*ULN); uric acid (>1.2*ULN); sodium, potassium, chloride, calcium, bicarbonate (<0.9*LLN></0>1.1*ULN); urine RBCs, urine white blood cells (WBCs) (> or equal[=]20 high-powered field), urine bacteria >20 high-powered field. Total number of participants with any laboratory abnormalities were reported.|Baseline up to Day 42|Safety population included all participants who received at least 1 dose of study medication.||participants|||Number
694924|NCT01396187|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Day 77 which were absent before treatment or that worsened relative to pretreatment state.|Baseline up to Day 77|Safety population included all participants who received at least 1 dose of study medication.||participants|||Number
694925|NCT01396187|Primary|Number of Participants With Abnormal Physical Examination Findings|Physical examination included assessment of height, weight, blood pressure, pulse rate and body temperature. Criteria for abnormal physical findings was based on investigator’s discretion and were reported as adverse event (AE), as planned.|Baseline up to Day 42|Physical examination data reported in this study was for identification of adverse events and were reported as adverse event in the AE section.|||||
694926|NCT01396161|Secondary|Urinary Recovery|Percentage of PF-05175157 excreted unchanged in urine over the dosing interval.|Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11|PKP analysis population; Participants Analyzed (N): number of participants with evaluable data||percentage||Standard Deviation|Mean
694927|NCT01396161|Secondary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11|It was not possible to calculate data for half-life as the calculation required the slope of terminal elimination phase and the PK sampling was insufficient to characterize the terminal elimination phase, which is needed for the calculation of the half-life.|||||
694928|NCT01396161|Secondary|Renal Clearance (CLr)|CLr is the amount of unchanged drug excreted in the participants urine from time zero to end of dosing interval.|Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11|PKP analysis population; Participants Analyzed (N): number of participants with evaluable data||mL/min||Standard Deviation|Mean
694929|NCT01396161|Secondary|Accumulation Ratio for Area Under the Concentration-Time Curve (Rˇac, AUC)|Rˇac for the AUC is defined as AUC (τ, single dose [ss]) / AUC (τ, multiple dose [sd]).|Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11|PKP analysis population; Participants Analyzed (N): number of participants with evaluable data||ratio||Standard Deviation|Mean
694930|NCT01396161|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)||Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11|PKP analysis population; Participants Analyzed (N): number of participants with evaluable data||µg times (*)hr divided by mL (µg *hr/mL)||Standard Deviation|Mean
694931|NCT01396161|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11|Pharmacokinetic Parameter (PKP) Analysis Population: all enrolled participante who received at least 1 dose of PF05175157 and had at least 1 PKP of interest calculated;Number of Participants Analyzed (N): number of participants with evaluable data||hours (hrs)||Full Range|Median
694932|NCT01396161|Secondary|Maximum Observed Plasma Concentration (Cmax)||Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11|Pharmacokinetic Concentration (PKC) Analysis Population: all enrolled participants who received at least 1 dose of PF-05175157 and had at least 1 concentration value reported. Number of Participants Analyzed (N): number of participants with evaluable data||micrograms per milliliter (µg/mL)||Standard Deviation|Mean
694933|NCT01396161|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to PF-05175157 was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.|2 weeks|Safety Analysis Set: all participants who received at least 1 dose of study medication (PF-05175157 or placebo).||participants|||Number
694934|NCT01396083|Secondary|Increase Rate of the Internal Ocular Pressure (IOP ) : Patients With ≥10% Increase in IOP Compared to Baseline|The proportion of patients with ≥ 10% increase in Internal Ocular Pressure (IOP) compared to baseline at any post-baseline visit.|Baseline, month 6|The Safety Set consisted of all patients from the RS who had received at least one application of study treatment and had at least one post-baseline safety assessment. Patients were analyzed according to treatment received. The statement that a patient had no adverse events also constituted a safety assessment||Participants|||Number
694935|NCT01396083|Secondary|Changes in the Quality of Life According to Euro Quality of Life (EQ-5D) Questionnaires|The EQ-5D visual analog scale ranges from 0 to 100, 0 representing the worst and 100 the best imaginable health state.|Baseline, month 6|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Observed participants are only described in this analysis||Units on a scale||Standard Deviation|Mean
694937|NCT01396083|Secondary|Changes in the Quality of Life According to the National Eye Institute Visual Function Questionnaire (NEI-VFQ 25) Questionnaires|The VFQ-25 composite and subscale scores range from 0 to 100, a higher score indicating better functioning. The 12 subscales in the VFQ-25 are general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. The scores on the subscales were added together for a total score, which ranged from 0 to 100. A higher score indicated improvement in quality of life due to vision function|Baseline, month 6|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned||Score on a scale||Standard Deviation|Mean
694938|NCT01396083|Secondary|Change Over Time of the Central Retinal Thickness (CRT)|Retinal thickness was measured using Optical Coherence Tomography (OCT). The images were reviewed by a central reading center to ensure a standardized evaluation|Baseline, month 6|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned||µm||Standard Deviation|Mean
694939|NCT01396083|Secondary|Change Over Time in BCVA|The analysis was performed by an analysis of covariance (ANCOVA) model with average change in BCVA (letters) from Visit 1 through Visit 6 as dependent variable, and with the factors center, treatment and covariate baseline BCVA as predictors|Baseline, month 6|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned||letters||95% Confidence Interval|Least Squares Mean
694940|NCT01396083|Secondary|Time to Achieve a Significant Improvement ≥ 15 Letters|The time was analyzed by the Kaplan-Maier-Method, adjusting the calculation for dropouts|Baseline, month 6|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned||Time to event (Days)||95% Confidence Interval|Median
694941|NCT01396083|Secondary|Number of Patients Gaining / Losing ≥ 15 / 10 / 5 Letters|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the number of participants who gained 15, 10 or 5 more letters of visual acuity at month 6 as compared with baseline|Baseline, 6 month|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned||Participants|||Number
694942|NCT01396083|Secondary|Mean BCVA Change at Month 6|The analysis was performed by an analysis of covariance (ANCOVA) model with average change in BCVA (letters) from Visit 1 through Visit 6 as dependent variable, and with the factors center, treatment and covariate baseline BCVA as predictors|Baseline, month 6|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned||Letters||95% Confidence Interval|Least Squares Mean
694943|NCT01396083|Primary|Mean Average BCVA Change From Month 1 Through Month 6 to Baseline|the average of the changes in BCVA (letters) from baseline to any post-baseline visit, i.e. the mean of six differences to baseline for the six post-baseline visits at month 1 to 6. BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is pproximately 20/20. An increased score indicates improvement in acuity|Baseline, month 6|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned||Letters||Standard Deviation|Mean
694944|NCT01396070|Secondary|Overall Non-Evaluable Response|"Overall Non-Evaluable Response of full patient population
3 subjects were not evaluable."|4 weeks|||Participants|||Count of Participants
694945|NCT01396070|Secondary|Overall Partial Response Rate|"Overall Partial Response Rate (PR) in this study population.
3 subjects were not evaluable."|2 years|||Participants|||Count of Participants
694946|NCT01396070|Secondary|Overall Stable Disease Rate|"Overall Stable Disease Rate (SD) in this study population.
3 subjects were not evaluable."|2 years|||Participants|||Count of Participants
694947|NCT01396070|Primary|Overall Response Rate (ORR)|Overall response rate of brentuximab vedotin in this study population.|2 years|The percentage was calculated by adding Complete response (CR) + Partial Response (PR) = Overall rate. 3 subjects were not evaluable.||percentage|||Number
694948|NCT01396057|Secondary|Rate of the Internal Ocular Pressure (IOP)|The proportion of patients with ≥ 10% increase in IOP compared to baseline at any post-baseline visit.|Baseline, month 6|The Safety Set consisted of all patients from the RS who had received at least one application of study treatment and had at least one post-baseline safety assessment. Patients were analyzed according to treatment received. The statement that a patient had no adverse events also constituted a safety assessment||Participants|||Number
694949|NCT01396057|Secondary|Changes in the Quality of Life According to Euro Quality of Life (EQ-5D) Questionnaires|The EQ-5D visual analog scale ranges from 0 to 100, 0 representing the worst and 100 the best imaginable health state.|Baseline, month 6|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Observed participants are only described in this analysis||Units on a scale||Standard Deviation|Mean
694964|NCT01396044|Primary|Proportion of Empiric Antibiotics|The difference between the electronic checklist and prompted groups' proportion of all antibiotics that were administered empirically (empiric/total antibiotics).|ICU admission|All patients who received at least one day of empirical antibiotics during their ICU admission.||proportion of antibiotic-days||Standard Deviation|Mean
694950|NCT01396057|Secondary|Changes in the Quality of Life According to the Short Form (36) Health Survey (SF-36)Questionnaires|SF-36 summary measures are norm-based scores with mean = 50 and SD = 10. Higher scores indicate better health|Baseline, month 6|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. observed is only described in this analysis.||Units on a scale||Standard Deviation|Mean
694951|NCT01396057|Secondary|Changes in the Quality of Life According to the National Eye Institute Visual Function Questionnaire (NEI-VFQ 25) Questionnaires|The VFQ-25 composite and subscale scores range from 0 to 100, a higher score indicating better functioning. The 12 subscales in the VFQ-25 are general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. The scores on the subscales were added together for a total score, which ranged from 0 to 100. A higher score indicated improvement in quality of life due to vision function.|Baseline, month 6|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned||Score on a scale||Standard Deviation|Mean
694952|NCT01396057|Secondary|Change Over Time of the Central Retinal Thickness (CRT)|Retinal thickness was measured using Optical Coherence Tomography (OCT). The images were reviewed by a central reading center to ensure a standardized evaluation|Baseline, month 6|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned||µm||Standard Deviation|Mean
694953|NCT01396057|Secondary|Change Over Time in BCVA|The analysis was performed by an analysis of covariance (ANCOVA) model with average change in BCVA (letters) from Visit 1 through Visit 6 as dependent variable, and with the factors center, treatment and covariate baseline BCVA as predictors|baseline, month 6|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned||Letters||95% Confidence Interval|Least Squares Mean
694954|NCT01396057|Secondary|Time to Achieve a Significant Improvement ≥ 15 Letters|The time was analyzed by the Kaplan-Maier-Method, adjusting the calculation for dropouts|Baseline, month 6|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned||Time to event (Days)||95% Confidence Interval|Median
694955|NCT01396057|Secondary|Percentage of Patients Gaining / Losing ≥ 15 / 10 / 5 Letters After 6 Month Treatment|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained 15, 10 or 5 more letters of visual acuity at month 6 as compared with baseline|Baseline, 6 month|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned||Participants|||Number
694956|NCT01396057|Secondary|Mean BCVA Change From Baseline to Endpoints Month 1 to Month 6|The analysis was performed by an analysis of covariance (ANCOVA) model with average change in BCVA (letters) from Visit 1 through Visit 6 as dependent variable, and with the factors center, treatment and covariate baseline BCVA as predictors|Baseline, month 6|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned||Letters (EDTRS)||95% Confidence Interval|Least Squares Mean
694957|NCT01396057|Primary|Mean Average Best Corrected Visual Acuity (BCVA) Change From Month 1 Through Month 6 to Baseline|the average of the changes in BCVA (letters) from baseline to any post-baseline visit, i.e. the mean of six differences to baseline for the six post-baseline visits at month 1 to 6|Baseline, month 6|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned||Letters||Standard Deviation|Mean
694958|NCT01396044|Secondary|Standardized Mortality Ratio||Hospital admission|All patients treated with at least one day of empirical antibiotics.||observed/expected deaths||95% Confidence Interval|Mean
694959|NCT01396044|Secondary|Proportion of Patients-days on Which Empirical Antibiotics Were Used|Proportion of patients-days on which empirical antibiotics were used|ICU admission|All patients who received at least one day of empirical antibiotics.||Number of patient-days|||Number
694960|NCT01396044|Secondary|Proportion of Successful Prompts|"Prompting group: number of patient-days that prompting led to empirical antibiotics being discontinued or narrowed/number of patient-days prompting occurred
Electronic checklist group: number of patient-days that electronic checklist led to empirical antibiotics being discontinued or narrowed/number of patient-days electronic checklist was completed"|During ICU admission, an average of 5 days (although individual patients may vary)|All patients treated with at least one day of empirical antibiotics.||proportion of patient-days|||Number
694961|NCT01396044|Secondary|Ventilator-free Days|Number of days within the first 28 days after ICU admission that a patient does not require mechanical ventilation.|During hospitalization, an average of 2 weeks per patient (although individual patients may vary)|All patients treated with at least one day of empirical antibiotics.||days||Inter-Quartile Range|Median
694962|NCT01396044|Secondary|Length of Stay||During hospitalization, an average of 2 weeks per patient (although individual patients may vary)|All patients treated with at least one day of empirical antibiotics.||days||Inter-Quartile Range|Median
694963|NCT01396044|Secondary|Hospital Mortality||During hospitalization, an average of 2 weeks per patient (although individual patients may vary)|All patients treated with at least one day of empirican antibiotics during ICU admission||number of deaths|||Number
694966|NCT01396005|Secondary|Cmax of Naloxone (Administered in Combination With Buprenorphine) at Steady State With or Without Boceprevir|Cmax is a measure of the maximum level of drug in the blood, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). The Day 1, 0 through 24 hour samples were for buprenorphine/naloxone levels in the absence of boceprevir co-administration. The Day 7, 0 through 24 hour samples were for buprenorphine/naloxone levels in the presence of boceprevir co-administration. The Day 5 and 6 predose samples were to check steady state for buprenorphine/naloxone + boceprevir.|Buprenorphine/naloxone samples collected Day 1, 0 (predose) through 24 hours post-dose (Day 2). Boceprevir and buprenorphine/naloxone samples collected Day 7, 0 (predose) through 24 hours post-dose (Day 8). Predose samples also collected on Days 5-6.|All participants on Day 1; 1 participant discontinued on Day 6.||(pg/mL)/mg||Geometric Coefficient of Variation|Geometric Mean
694967|NCT01396005|Secondary|AUC of Naloxone (Administered in Combination With Buprenorphine) at Steady State With or Without Boceprevir|AUC is a measure of the amount of drug in the blood over time, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). The Day 1, 0 through 24 hour samples were for buprenorphine/naloxone levels in the absence of boceprevir co-administration. The Day 7, 0 through 24 hour samples were for buprenorphine/naloxone levels in the presence of boceprevir co-administration. The Day 5 and 6 predose samples were to check steady state for buprenorphine/naloxone + boceprevir.|Buprenorphine/naloxone samples collected Day 1, 0 (predose) through 24 hours post-dose (Day 2). Boceprevir and buprenorphine/naloxone samples collected Day 7, 0 (predose) through 24 hours post-dose (Day 8). Predose samples also collected on Days 5-6.|All participants on Day 1; 2 participants were discontinued from study (Days 2-8).||(pg.hr/mL)/mg||Geometric Coefficient of Variation|Geometric Mean
694968|NCT01396005|Primary|Cmax of Buprenorphine (Administered in Combination With Naloxone) at Steady State With or Without Boceprevir|Cmax is a measure of the maximum level of drug in the blood, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). The Day 1, 0 through 24 hour samples were for buprenorphine/naloxone levels in the absence of boceprevir co-administration. The Day 7, 0 through 24 hour samples were for buprenorphine/naloxone levels in the presence of boceprevir co-administration. The Day 5 and 6 predose samples were to check steady state for buprenorphine/naloxone + boceprevir.|Buprenorphine/naloxone samples collected Day 1, 0 (predose) through 24 hours post-dose (Day 2). Boceprevir and buprenorphine/naloxone samples collected Day 7, 0 (predose) through 24 hours post-dose (Day 8). Predose samples also collected on Days 5-6.|All participants on Day 1; 1 participant discontinued from study on Day 6.||(pg/mL)/mg||Geometric Coefficient of Variation|Geometric Mean
694969|NCT01396005|Primary|AUC of Buprenorphine (Administered in Combination With Naloxone) at Steady State With or Without Boceprevir|AUC is a measure of the amount of drug in the blood over time, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). The Day 1, 0 through 24 hour samples were for buprenorphine/naloxone levels in the absence of boceprevir co-administration. The Day 7, 0 through 24 hour samples were for buprenorphine/naloxone levels in the presence of boceprevir co-administration. The Day 5 and 6 predose samples were to check steady state for buprenorphine/naloxone + boceprevir.|Buprenorphine/naloxone samples collected Day 1, 0 (predose) through 24 hours post-dose (Day 2). Boceprevir and buprenorphine/naloxone samples collected Day 7, 0 (predose) through 24 hours post-dose (Day 8). Predose samples also collected on Days 5-6.|All participants on Day 1; 2 participants were discontinued from study (Days 2-8).||(pg.hr/mL)/mg||Geometric Coefficient of Variation|Geometric Mean
694970|NCT01396005|Primary|Maximum Concentration (Cmax) at Steady State of Methadone Enantiomers When Administered With or Without Boceprevir|Cmax is a measure of the maximum level of drug in the blood, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). The Day 1, 0 through 24 hour samples were for methadone levels in the absence of boceprevir co-administration. The Day 7, 0 through 24 hour samples were for methadone levels in the presence of boceprevir co-administration. The Day 5 and 6 predose samples were to check steady state for methadone + boceprevir.|Methadone samples collected Day 1, 0 (predose) through 24 hours post-dose (Day 2). Boceprevir and methadone samples collected Day 7, 0 (predose) through 24 hours post-dose (Day 8). Predose samples also collected on Days 5-6.|All participants receiving standard methadone maintenance therapy + boceprevir||(ng/mL)/mg||Geometric Coefficient of Variation|Geometric Mean
694971|NCT01396005|Primary|Area Under the Concentration Versus Time Curve (AUC) at Steady State of Methadone Enantiomers When Administered With or Without Boceprevir|AUC is a measure of the amount of drug in the blood over time, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). The Day 1, 0 through 24 hour samples were for methadone levels in the absence of boceprevir co-administration. The Day 7, 0 through 24 hour samples were for methadone levels in the presence of boceprevir co-administration. The Day 5 and 6 predose samples were to check steady state for methadone + boceprevir.|Methadone samples collected Day 1, 0 (predose) through 24 hours post-dose (Day 2). Boceprevir and methadone samples collected Day 7, 0 (predose) through 24 hours post-dose (Day 8). Predose samples also collected on Days 5-6.|All participants receiving standard methadone maintenance therapy + boceprevir||(ng.hr/mL)/mg||Geometric Coefficient of Variation|Geometric Mean
694972|NCT01395966|Primary|Time to Cessation of Otorrhea||From baseline until the end of the study ( up to 22 days)|||days||95% Confidence Interval|Median
694973|NCT01395914|Secondary|Change in A/CS Domain Score|"Change in the Functional Assessment of Anorexia/Cachexia Treatment (FAACT) 12-item Additional Concerns Subscale (A/CS) domain score is a 12-item scale. Each item is answered on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much).
The 12-items are summed together to obtain the domain score. Note that negatively phrased questions are reverse scored so that higher scores always represent improvement/less symptom burden. The total possible score for the A/CS domain ranges from 0 (worst) to 48 (best)."|Change in FAACT A/CS Domain Score from baseline of the original trial through Week 12 of this extension trial|||scores on a scale||Standard Error|Least Squares Mean
694974|NCT01395914|Secondary|Change in Handgrip Strength of the Non-Dominant Hand||Change in HGS from baseline of the original trial through Week 12 of this extension trial.|Intent-to-Treat Population||kg||Standard Error|Least Squares Mean
694975|NCT01395914|Secondary|Change in Body Weight||Change in body weight from baseline of the original trial through Week 12 of this extension trial.|Intent-to-Treat Population||kg||Standard Error|Least Squares Mean
694978|NCT01395901|Secondary|Proportion of Patients Without Antiemetic Rescue Medication|Rescue medications are any medications with potential antiemetic effect taken in the 24 hours after patient wake-up from anaesthesia (T0).Time 0 (T0) was defined as the time when the patient wakes up and is able to show any active reaction postoperatively.|0-24 hours after T0|The Full Analysis Set (FAS) population.||percentage of patients||95% Confidence Interval|Number
694979|NCT01395901|Secondary|Proportion of Patients Without Emetic Episodes|An emetic episode was defined as one or more continuous vomits (expulsion of stomach contents through the mouth) or retches (an attempt to vomit that is not productive of stomach contents). Time 0 (T0) was defined as the time when the patient wakes up and is able to show any active reaction postoperatively.|0-24 hours after T0|The Full Analysis Set (FAS) population.||percentage of patients||95% Confidence Interval|Number
694980|NCT01395901|Secondary|Proportion of Patients With no Vomiting|Time 0 (T0) was defined as the time when the patient wakes up and is able to show any active reaction postoperatively.|0-24 hours after T0|The Full Analysis Set (FAS) population.||percentage of patients||95% Confidence Interval|Number
694981|NCT01395901|Primary|Proportion of Patients With Complete Response|Complete Response was defined as no vomiting, no retching, and no use of antiemetic rescue medication during the first 24 hours postoperatively, starting at T0. Time 0 (T0) was defined as the time when the patient wakes up and is able to show any active reaction postoperatively.|0-24 hours after T0|The Full Analysis Set (FAS) included all randomized patients who received the active study drug, general anesthesia and surgery (evaluable patients). Following the intent-to-treat principle, patients were assigned to the study treatment arm according to their randomized treatment.||percentage of patients||95% Confidence Interval|Number
694982|NCT01395888|Primary|Mean Change From Baseline (BL) in Aortic Pulse Wave Velocity (aPWV) at the End of the 12-week Treatment Period (Day 84)|PWV is defined as the speed of travel of the pressure pulse along an arterial segment and can be obtained for any arterial segment accessible to palpation. aPWV is measured with tonometers positioned transcutaneously at the base of the common carotid artery and over the femoral artery. PWV increases with arterial stiffness and is defined by the Moens-Korteweg equation: PWV=square root of Eh/2pR, where E is Young’s modulus of the arterial wall, h is the wall thickness, R is the arterial radius at the end of diastole, and p is the blood density. Change from Baseline was calculated as the Day 84 value minus the Baseline value. The analysis was performed using a repeated measures model with covariates of treatment, visit, age, gender, smoking status at screening, geographical region, Baseline aPWV, and interaction terms of Baseline by visit and treatment by visit.|Baseline to Day 84 (Early Withdrawal)|Intent-to-Treat (ITT) Population: all participants (par.) who were randomized to and received >=1 dose of randomized medication in the TP. The analysis model included all par. in the ITT Population without missing covariate information (MCI) and with >=1 post-BL measurement. Par. presented represent those with data available at Day 84 without MCI.||meters per second (m/sec)||Standard Error|Least Squares Mean
694983|NCT01395823|Primary|EPO Dose|The primary outcome is the change in the median EPO dose from baseline to 6 months after ergocalciferol supplementation.|Baseline, 6 months|||units/week||Inter-Quartile Range|Median
694984|NCT01395797|Secondary|Measures of Subjective Drug Effects Most Commonly Indicative of Abuse Liability.|"Visual analog scale ratings of Liking reported by the participant will be the primary endpoint (0-100 mm, 0=Not at all, 100=Extremely)."|Following 2 weeks of Pioglitazone (PIO) maintenance.|||units on a scale||Standard Error|Mean
694985|NCT01395797|Primary|Drug's Break Point|Number of operant responses (mouse clicks) participants were willing to provide in order to receive the drug under investigation (heroin or nicotine). The Breakpoint is the point at which participants stopped responding for the drug, i.e., the total number of clicks they were willing to provide in order to receive the drug.|Following 2 weeks of Pioglitazone (PIO) maintenance.|||Mouse clicks||Standard Deviation|Mean
694986|NCT01395784|Secondary|Analgesic Responses Using the Cold Pressor Test|Latency to withdraw hand from cold water during the cold pressor test.|Measured during the lab session conducted at the end of each maintenance period|||seconds||Standard Deviation|Mean
694987|NCT01395784|Primary|"Subjective Ratings of Good Drug Effect"|Visual analog scale ratings (0-100 mm scale, 0=Not at all, 100=Extremely)|Measured during the lab session conducted at the end of each maintenance period|Shown below are peak drug effects from each of the 3 maintenance periods (Placebo, Pioglitazone (PIO) 15, and PIO 45)||units on a scale||Standard Deviation|Mean
694988|NCT01395524|Primary|Incidence of Patients Experiencing Severe Adverse Events (SAEs)|The incidence of patients experiencing SAEs during the randomized treatment and follow-up periods was calculated.|Baseline (Week 0) to end of the follow-up period (Week 14)|The Safety analysis set included all patients who participated in Study D3820C00004 and received at least 1 dose of study drug in Study D3820C00007, with the exception of patients who were found to have randomized multiple times within the program at different centers.||Participants|||Number
694989|NCT01395524|Primary|Incidence of Patients Experiencing AEs That Resulted in Discontinuation of Investigational Product (IP)|The incidence of patients experiencing AEs that resulted in discontinuation of IP during the randomized treatment or follow-up periods was calculated.|Baseline (Week 0) to end of the follow-up period (Week 14)|The Safety analysis set included all patients who participated in Study D3820C00004 and received at least 1 dose of study drug in Study D3820C00007, with the exception of patients who were found to have randomized multiple times within the program at different centers.||Participants|||Number
694990|NCT01395524|Secondary|Change From Baseline in Patient Assessment of Constipation Quality of Life (PAC-QOL)|The PAC-QOL scale is a 28-item self-report instrument designed to evaluate the burden of constipation on patients’ everyday functioning and well-being in the 2 weeks (14 days) prior to assessment. Each item is rated on a 5-point Likert scale ranging from 0 (not at all) to 4 (extremely). The instrument can be used to generate an overall score, but is also reported to assess 4 specific constipation-related domains including: 1) Worries and concerns (11 items), 2) Physical discomfort (4 items), 3) Psychosocial discomfort (8 items), and 4) Satisfaction (5 items). Each domain score is the mean of the non-missing items for that domain. The total score is the mean of all non-missing items. The range of the domain or total score is 0 (response is 'not at all' for each item) to 4 (response is 'extremely' for each item). A negative change from baseline indicates improvement.|Baseline (prior to treatment) to last on-treatment assessment (up to Week 12)|The modified intent-to-treat (ITT) analysis set included all randomized patients, with the exception of patients who were found to have randomized multiple times within the program at different centers.The N denotes the number of patients with a baseline and last on-treatment value.||units on a scale||Standard Deviation|Mean
694991|NCT01395524|Secondary|Change From Baseline in Patient Assessment of Constipation Symptoms Questionnaire (PAC-SYM)|The PAC-SYM questionnaire is a 12-item questionnaire that evaluates the severity of symptoms of constipation in 3 domains (stool, rectal, and abdominal symptoms) on a 5-point Likert scale ranging from 0 (absent) to 4 (very severe) in the 2 weeks (14 days) prior to assessment. Each domain score is the mean of the non-missing items for that domain. The total score is the mean of all non-missing items (ie, symptoms). The range of the domain or total score is 0 (response is 'absent' for each item) to 4 (response is 'very severe' for each item). A negative change from baseline indicates improvement.|Baseline (prior to treatment) to last on-treatment assessment (up to Week 12)|The modified intent-to-treat(ITT) analysis set included all randomized patients, with the exception of patients who were found to have randomized multiple times within the program at different centers. The N denotes the number of patients with a baseline and last on-treatment value.||units on a scale||Standard Deviation|Mean
694992|NCT01395524|Primary|Incidence of Patients Experiencing at Least One Adverse Event (AE)|The incidence of patients experiencing at least one AE during the randomized treatment and follow-up periods was calculated.|Baseline (Week 0) to end of the follow-up period (Week 14)|The Safety analysis set included all patients who participated in Study D3820C00004 and received at least 1 dose of study drug in Study D3820C00007, with the exception of patients who were found to have randomized multiple times within the program at different centers.||Participants|||Number
694993|NCT01395394|Primary|C-Reactive Protein (CRP)|Markers will be assessed every other hour for each 6-hour study visit. Kuvan responders and healthy controls will only be assessed at one 6-hour study visit. Kuvan non-responders will be assessed at two study visits (a baseline visit, and a visit after two weeks of Kuvan therapy). Values will be assessed groupwise and also assessed for intrapersonal change in the Kuvan non-responsive group. Time frame of participation is estimated at one month.|CRP will be measured every other hour for six hours at baseline (study visit 1) for all study groups and again during a second visit 2 weeks after baseline in BH4 Non-Responders only (study visit 2)|Study was terminated due to difficulty recruiting patients, thus analysis was limited to preliminary data on 11 patients only. CRP was measured in 10 subjects - data were unavailable for 1 control participant due to inadequate sample volume.||mg/dl||Standard Deviation|Mean
694994|NCT01395394|Primary|Lipid Peroxidation|Markers will be assessed every other hour for each 6-hour study visit. Kuvan responders and healthy controls will only be assessed at one 6-hour study visit. Kuvan non-responders will be assessed at two study visits (a baseline visit, and a visit after two weeks of Kuvan therapy). Values will be assessed groupwise and also assessed for intrapersonal change in the Kuvan non-responsive group. Time frame of participation is estimated at one month.|Lipid peroxidation will be measured every other hour for six hours at baseline (study visit 1) for all study groups|Study was terminated due to difficulty recruiting patients, thus analysis was limited to preliminary data on 11 patients only. TBARS was measured in 3 BH4 responders only - data were unavailable for 8 other participants (2 responders, 3 non-responders, and 3 controls) due to inadequate sample volume.||umole/L||Standard Deviation|Mean
694995|NCT01395368|Primary|Brain Speed Test|Standardized Z-scores of the Brain Speed Test (BST-Z scores) calculated based on age group-matched normal population data were used for analysis in order to control for the impact of age on test scores. Age-standardized Z-scores, which reflect the distance from the mean in standard deviation values, allow for the comparison of scores across age groups. A z-score of 0 indicates a value of the average, while absolute z-score values above 2 indicate observations significantly different from normal populations.|Participants completed brain speed test on the same day as enrollment. No follow-up required.|Number of participants who completed the study with the exception of 4 subjects whose data was excluded due to the fact that they were younger than the the normative age-specific data available and BST Z-scores were not able to be calculated.||z-score||95% Confidence Interval|Mean
694996|NCT01395277|Secondary|Pulse Wave Velocity / Arterial Stiffness|Assessment of pulse wave velocity in the common carotid artery and the femoral artery provides an index of arterial stiffness.|Prior to (baseline) and 2 hours following beverage consumption|||cm / sec||Standard Deviation|Mean
694997|NCT01395277|Primary|Cutaneous Blood Flow Response to Local Heating of the Skin.|Local heating of the cutaneous vasculature to 42 degree C is commonly used to evoke a maximal skin blood flow response (only at the site of local heating). This response is almost entirely dependent on nitric oxide mediated vasodilation.|prior to (baseline) and 2 hours post beverage consumption|||percent change in mean skin blood flow||Standard Deviation|Mean
694998|NCT01395043|Primary|Postoperative Pain Using Numerical Rating Scale (NRS) 0-10|"NRS is a pain score and the score can vary between 0 and 10 by which 0 means no pain and 10 equals the worst possible pain.
NRS was evaluated at the time 0, 1, 2, 4, 8 , 12, 18 , 24 and 36 hours after arriving in the post anesthesia care unit at rest and during coughing."|0-36 hours postoperative|||Units on Numerical Rating Score||Inter-Quartile Range|Median
694999|NCT01395043|Secondary|Opioid Requirements Postoperative|Supplementary opioid requirements for the first 48 hours from arriving in the post anesthesia care unit. Results are total opioid-requirements for the first 48 hours. Way of administration was intravenous in all but 6 administrations. If given orally, a 1:3 ratio was used for conversion from oral to intravenous morphine.|48 hours from arriving in the post anesthesia care unit.|||mg iv morphin equivalent||95% Confidence Interval|Mean
695000|NCT01395017|Secondary|Progression Free Survival (PFS)|PFS - time from randomization to unequivocal local or distant disease progression, death or discontinuation from trial for any reason by 02 December 2013. Progression events were determined according to Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 every 8 weeks.|Time from randomization to earliest PFS event by 02 December 2013|The ITT data which was composed of all randomized participants.||Days||95% Confidence Interval|Median
695001|NCT01395017|Primary|Overall Survival|Overall survival (OS) is the time from randomization until time of death from any cause by 02 December 2013.|From randomization until date of death from any cause by 02 December 2013|The intent-to-treat (ITT) data which was composed of all randomized participants.||Days||95% Confidence Interval|Median
695002|NCT01394991|Secondary|Red Blood Cell Transfusions|The number of participants who received at least 1 red blood cell (RBC) transfusion (packed RBC or whole blood) during the study.|during the study (randomization through week 26)|All participants who were randomized, regardless of whether or not they received study drug.||participants|||Number
700132|NCT00036738|Secondary|Transplant-related Mortality|Number of patients with TRM within 100 days post-transplant.|At day 100|||Participants|||Count of Participants
695003|NCT01394991|Secondary|Number of Hemoglobin Responders|Hemoglobin response was defined as a hemoglobin increase of ≥2 g/dL from baseline or reaching a hemoglobin concentration of 12 g/dL, regardless of dose adjustment.|during the study (randomization through week 26)|All participants who were randomized, regardless of whether or not they received study drug.||participants|||Number
695004|NCT01394991|Secondary|Mortality|Number of participants who died during the study.|during the study (randomization through week 26)|All randomized participants who received at least 1 dose of study drug.||participants|||Number
695005|NCT01394991|Secondary|Time to First Suspected Thrombovascular Event|Analysis of time to first suspected thrombovascular event (TVE) measured from the date of randomization to the date of the first suspected TVE during the study. Median time is non-estimable because of too few events, incidence was reported instead.|during the study (randomization through week 26)|All randomized participants who received at least 1 dose of study drug.||participants|||Number
695006|NCT01394991|Secondary|Number of Suspected Thrombovascular Events|Number of participants who have at least 1 suspected thrombovascular events (TVEs) during the entire study. Suspected TVEs were defined as suspected TVEs during the entire study, whether clinically relevant and objectively confirmed by the Adjudication Committee or not, whether confirmed by the investigator or not.|during the study (randomization through week 26)|All randomized participants who received at least 1 dose of study drug.||participants|||Number
695007|NCT01394991|Secondary|Time to First Positively Adjudicated Thrombovascular Event|Analysis of time to first positively adjudicated thrombovascular event (TVE) measured from the date of randomization to the date of the first clinically relevant and objectively confirmed TVE as determined by the Adjudication Committee. Median time is non-estimable because of too few events, incidence was reported instead.|during the study (randomization through week 26)|All randomized participants who received at least 1 dose of study drug.||participants|||Number
695008|NCT01394991|Secondary|Number of Positively Adjudicated Thrombovascular Events|The number of participants who have at least 1 clinically relevant and objectively confirmed (adjudicated) thrombovascular event (TVE) during the study.|during the study (randomization through week 26)|The modified intent-to-treat (mITT) population used for safety analysis population included all randomized participants who received at least 1 dose of study drug.||participants|||Number
695009|NCT01394991|Primary|Number of Participants With at Least 1 Clinically Relevant and Objectively Confirmed Thrombovascular Event From Randomization Through Week 16|Clinically relevant and objectively confirmed thrombovascular event (TVE) was determined by the Adjudication Committee from randomization through Week 16. Clinically relevant TVEs were defined as deep vein thrombosis (DVT) of the limbs; thromboses of other major veins; pulmonary embolism (PE);acute coronary syndrome (ACS);ischemic stroke of arterial or cardiac origin; cerebral venous thrombosis; and arterial thrombosis. Objectively confirmed was defined as the confirmation of the clinical diagnosis of a TVE by appropriate medical imaging studies and laboratory tests.|from randomization through Week 16|The modified intent-to-treat (mITT) population was defined to include all randomized participants who received at least 1 dose of study drug.||particpants|||Number
695010|NCT01394978|Primary|Safety Endpoints|"Pulmonary adverse events: pneumothorax, persistent air leak, late onset air leak, residual pleural space, and acute respiratory distress syndrome
Renal adverse events
Cardiac adverse events
Death (all causes)
Hospital readmission"|90 days|Units analyzed represents the number of adverse events that occurred among all study participants in each arm.||Events|Events||Count of Units
695011|NCT01394926|Secondary|Detecting the Presence of Greater Than or Equal to 50% Stenosis and Greater Than or Equal to 75% Stenosis in the Carotid Arteries When Comparing Pre-contrast to Post-contrast Ultrasound by Dose Group.|Detecting the presence of greater than or equal to 50% stenosis and greater than or equal to 75% stenosis in the carotid arteries when comparing pre contrast to post-contrast U/S by dose group.Using the 3 different dose levels of 0.15 mL, 0.5 mL and 1.5 mL of Optison.|Up to 10 minutes post contrast administration.|Due to difficulty enrolling subjects in all three dose levels of Optison , this study was stopped prematurely. No efficacy analyses were performed.|||||
695012|NCT01394926|Primary|Finding the Optimal Dose of Optison From 3 Different Dose Levels; 0.15mL, 0.5mL, and 1.5mL.|Assessing the presence of disease of the carotid arteries when comparing pre-contrast to post-contrast ultrasound (U/S) by dose group. Using the optimal dose from 3 different dose levels - 0.15 mL, 0.5 mL and 1.5 mL of Optison.|Up to 10 minutes post contrast administration.|Due to difficulty enrolling subjects in all three dose levels of Optison, this study was stopped prematurely. No efficacy analyses were performed.|||||
695013|NCT01394718|Secondary|Average Pruritus Score|Pruritus scores were recorded by the nursing staff approximately 4 times over the first 24 hours and then averaged for the 24 hour period. Pruritus scores range from 1 (none) to 3 (intolerable).|24 hours|Subjects were deemed evaluable if a minimum of 24 hours of data was collected post-operatively, with receipt of at least four doses of study drug, prior to study withdrawal or unblinding, with T0 (time zero) being time of administration of first dose of either treatment drug or placebo||units on a scale||Full Range|Median
695014|NCT01394718|Secondary|Average Nausea Score|Nausea scores were recorded by the nursing staff approximately 4 times over the first 24 hours and then averaged for the 24 hour period. Nausea Scores range from 1 (none) to 4 (severe).|24 hours|Subjects were deemed evaluable if a minimum of 24 hours of data was collected post-operatively, with receipt of at least four doses of study drug, prior to study withdrawal or unblinding, with T0 (time zero) being time of administration of first dose of either treatment drug or placebo||units on a scale||Full Range|Median
695015|NCT01394718|Secondary|Average Pain Score|Pain Scores were monitored using the numeric pain assessment scale in both treatment arms of the study and recorded and averaged for the first 24 hours after initial intra-operative dose of study drug. The numeric pain assessment scale is a verbal self-reported pain assessment that ranges between 1 (no pain) to 10 (worst pain imaginable).|24 hours|Subjects were deemed evaluable if a minimum of 24 hours of data was collected post-operatively, with receipt of at least four doses of study drug, prior to study withdrawal or unblinding, with T0 (time zero) being time of administration of first dose of either treatment drug or placebo||units on a scale||Standard Deviation|Mean
695061|NCT01393899|Secondary|Fecal Calprotectin by Week|Fecal calprotectin is an inflammatory marker for the gastrointestinal tract and considered as a measurement of neutrophil migration to the gastrointestinal tract. Higher values indicate more serious inflammation.|Baseline and Weeks 8, 12 and 26|mFAS||milligrams per kilogram (mg/kg)||Standard Deviation|Mean
695016|NCT01394718|Primary|Total Opiate Requirement|Total opiate requirement was monitored 24 hours post-operatively. Morphine and hydromorphone measurements were totaled and recorded in mg/kg/day of morphine equivalents.|24 hours|Subjects were deemed evaluable if a minimum of 24 hours of data was collected post-operatively, with receipt of at least four doses of study drug, prior to study withdrawal or unblinding, with T0 (time zero) being time of administration of first dose of either treatment drug or placebo.||mg/kg||Standard Deviation|Mean
695017|NCT01394692|Secondary|Neurological Deficit|Assessment of new postoperative deficits following tumor surgery|7 days||||||
695018|NCT01394692|Secondary|Volumetric Assessment|Volumetric assessment of the extent of resection on early (within 72h) postoperative MRI|72 hours||||||
695019|NCT01394692|Secondary|Progression-free Survival|Progression-free survival (radiological and/or clinical progression) at 6 months following surgery|6 months||||||
695020|NCT01394692|Primary|Extent of Resection|Number of patients with contrast-enhancing glioma in whom a complete excision of the tumor according to postoperative high-field MRI within 72 hours is achieved|72 hours|Patients in whom histological examination of tumor specimens did not result in diagnosis of a glioma were excluded for final analysis.||participants|||Number
695021|NCT01394614|Primary|Incidence of Narcolepsy Among Narcoleptic Subjects Exposed or Unexposed to Vaccine|Incidence rates will be computed by comparing narcolepsy incidence rates in exposed and non-exposed subjects. Comparison of narcolepsy incidence rates in the period prior to vaccine administration and pseudo-vaccine administration will be used to test the comparability of exposed and non-exposed group.|Narcolepsy onset during the 16-week post-vaccination period.|||events per 100,000 person-years|||Number
695022|NCT01394510|Secondary|Oral Disposition Index|The change in the oral disposition index defined was the change in the early insulin response divided by the change in glucose from 0-30 minutes during the oral glucose tolerance test divided by fasting insulin.|4 weeks|||mg/dl||Standard Deviation|Mean
695023|NCT01394510|Secondary|Area Under the Curve for Glucose (AUCg)|Change in AUCg from 0-120 minutes during the oral glucose tolerance test at 4 weeks compared to baseline|4 weeks|||mg/dl x 120 minutes||Standard Deviation|Mean
695024|NCT01394510|Primary|Fasting Urine F2 Alpha Isoprostane Levels|Change in fasting urine isoprostane levels at 4 weeks vs baseline as a marker of oxidative stress|4 weeks|Change in urine F2 alpha isoprostanes/mg urine creatinine. Urine isoprostanes were only measured in a subset of participants due to lack of effect of the intervention on glucose tolerance.||ng/ml||Standard Deviation|Mean
695025|NCT01394276|Secondary|Mean Score of Health Assessment Questionnaire in the Participants With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs and Anti-Tumor Necrosis Factors Agents|The HAQ is a participant-completed questionnaire specific for RA, recommended by the American college of Rheumatology for the evaluation of quality of life. It consists of 20 questions referring to 8 component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities. There are 4 possible responses for each question: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, 3 = unable to do. To calculate HAQ, participant must have a component set score for at least 6 of 8 component set. The HAQ is the sum of the scores, divided by the number of component set that have a score (in range 6-8) for a total possible score minimum/maximum 0 (best) to 3 (worst). Data allowing the evaluation of HAQ was available for 73 participants in DMARD-IR group and 157 participants in DMARD + anti-TNF-IR group.|Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12|The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication. The “n” represents the number of participants analyzed at a specified time point.||units on a scale||Standard Deviation|Mean
695026|NCT01394276|Secondary|Mean Score of Fatigue Based on Visual Analogue Scale in the Participants With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs and Anti-Tumor Necrosis Factors Agents|VAS for fatigue is a 100 mm scale for participant’s assessment of their current level of fatigue: 0 mm corresponds to “no perception of fatigue”; 100 mm is the “maximum that may be perceived”. The mean VAS fatigue scores were evaluated after the first infusion of TCZ in two different sub populations, classified according to the previous pharmacological treatment: participants with inadequate response to DMARD (DMARD-IR: group A) or to DMARD and anti-TNF drugs (DMARD + anti-TNF-IR: group B). Data allowing the evaluation of fatigue (VAS) was available for 45 participants in DMARD-IR group and 113 participants in DMARD + anti-TNF-IR group.|Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12|"The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication. The n represents the number of participants analyzed at a specified time point."||units on a scale||Standard Deviation|Mean
695027|NCT01394276|Secondary|Mean Disease Activity Score Based on 28 Joint Count Score in the Participants With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs and Anti-Tumor Necrosis Factors Agents|The DAS28 index applies a mathematical formula based on the following parameters: 1. Tender joints count (28 joints), 2. Swollen joints count (28 joints) 3. ESR or CRP measurement, 4. Participant’s judgment on his own overall health status expressed by a VAS and calculates total score of 0 to approximately 10. The DAS28 scale ranges from 0 to 10, where scores below 2.6 indicate best disease control, scores above 5.1 indicate worse disease control. The response to therapy is defined according to the disease activity detected, compared to the previous clinical evaluation. The mean DAS28 scores were evaluated after the first infusion of TCZ in two different sub populations: participants with inadequate response (IR) to DMARD (DMARD-IR: group A) or to DMARD and anti-TNF drugs (DMARD + anti-TNF-IR: group B). Data allowing the evaluation of DAS28 was available for 81 participants in DMARD-IR group and 203 participants in DMARD + anti-TNF-IR group.|Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12|"The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication. The n represents the number of participants analyzed at a specified time point."||units on a scale||Standard Deviation|Mean
695062|NCT01393899|Secondary|Change From Baseline in CRP by Week|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Weeks 4, 8, 12, 20 and 26|mFAS||milligram per liter (mg/L)||Standard Deviation|Mean
695481|NCT01389882|Secondary|Work of Breathing|Work of breathing of patients measured by a ventilator for 4 hours with each ventilator mode|four hours|"The analysis was per protocol. 19 patients who had completed the study was used for the analysis."||mJ/L||Full Range|Median
695028|NCT01394276|Secondary|Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand.|The presence and severity of SH and JE of third MCP joint of left hand was determined by ultrasound examination. According to the method proposed by Naredo, SH and JE were evaluated based on scoring from 1 to 3 (1 = mild, 2 = moderate, 3 = marked). Vascularization of third MCP joint of left hand was evaluated with power doppler ultrasound and the score was assessed by a semi quantitative scale ranging from 0 to 3 (0 = normal; 1 = slight, evidence of a single flow signal; 2 = moderate, confluent vessels; 3 = marked, evidence of multiple flow signals in over half the intra-articular surface).|Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12|The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication.||participants|||Number
695029|NCT01394276|Secondary|Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand|The presence and severity of SH and JE of second MCP joint of left hand was determined by ultrasound examination. According to the method proposed by Naredo, SH and JE were evaluated based on scoring from 1 to 3 (1 = mild, 2 = moderate, 3 = marked). Vascularization of second MCP joint of left hand was evaluated with power doppler ultrasound and the score was assessed by a semi quantitative scale ranging from 0 to 3 (0 = normal; 1 = slight, evidence of a single flow signal; 2 = moderate, confluent vessels; 3 = marked, evidence of multiple flow signals in over half the intra-articular surface).|Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12|The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication.||participants|||Number
695030|NCT01394276|Secondary|Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand.|The presence and severity of SH and JE of third MCP joint of right hand was determined by ultrasound examination. According to the method proposed by Naredo, SH and JE were evaluated based on scoring from 1 to 3 (1 = mild, 2 = moderate, 3 = marked). Vascularization of third MCP joint of right hand was evaluated with power doppler ultrasound and the score was assessed by a semi quantitative scale ranging from 0 to 3 (0 = normal; 1 = slight, evidence of a single flow signal; 2 = moderate, confluent vessels; 3 = marked, evidence of multiple flow signals in over half the intraarticular surface).|Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12|The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication.||participants|||Number
695031|NCT01394276|Secondary|Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand.|The presence and severity of synovial hyperplasia (SH) and joint effusion (JE) of second metacarpo-phalangeal (MCP) joint of right hand was determined by ultrasound examination. According to the method proposed by Naredo, synovial hyperplasia and joint effusion were evaluated based on scoring from 1 to 3 (1 = mild, 2 = moderate, 3 = marked). Vascularization was evaluated with power doppler ultrasound and the score was assessed by a semi quantitative scale ranging from 0 to 3 (0 = normal; 1 = slight, evidence of a single flow signal; 2 = moderate, confluent vessels; 3 = marked, evidence of multiple flow signals in over half the intra articular surface).|Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12|The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication.||participants|||Number
695032|NCT01394276|Secondary|Percentage of Participants Still on Tocilizumab Treatment Till 12 Months After the 1st Infusion|Percentage of participants who continued treatment till 12 months after the first infusion with TCZ was reported.|Up to 12 months|The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication.||percentage of participants|||Number
695033|NCT01394276|Secondary|Number of Participants With Any Adverse Events and Serious Adverse Events|An adverse event (AE) was defined as any untoward medical occurrence in a participant who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment. A Serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.|Up to 12 months|The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication.||participants|||Number
695034|NCT01394276|Secondary|Percentage of Participants Discontinuing Treatment With Tocilizumab|The percentage of participants who prematurely discontinued treatment with TCZ during the study period was reported.|Up to 12 months|The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication.||percentage of participants|||Number
695035|NCT01394276|Secondary|Number of Participants With Concomitant Medications|Number of participants treated with at least one concomitant medication i.e., corticosteroid (Prednisone, Methyl prednisolone) was reported.|Up to 12 months|The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication.||participants|||Number
695036|NCT01394276|Secondary|Mean Score of Health Assessment Questionnaire in Participants on Monotherapy With Tocilizumab|The health assessment questionnaire (HAQ) is a participant-completed questionnaire specific for RA, recommended by the American college of Rheumatology for the evaluation of quality of life. It consists of 20 questions referring to 8 component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities. There are 4 possible responses for each question: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, 3 = unable to do. To calculate HAQ, the participant must have a component set score for at least 6 of 8 component set. The HAQ is the sum of the scores, divided by the number of component set that have a score (in range 6-8) for a total possible score of minimum/maximum i.e., 0 (best) to 3 (worst).|Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12|The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication. Data allowing the evaluation of HAQ was available for 66 participants in TCZ group. The “n” represents the number of participants analyzed at a specified time point.||units on a scale||Standard Deviation|Mean
695037|NCT01394276|Secondary|Mean Score of Fatigue Based on Visual Analogue Scale in Participants on Monotherapy With Tocilizumab|VAS for fatigue is a 100 mm scale for participant’s assessment of their current level of fatigue. The ‘0 ‘mm corresponds to “no perception of fatigue,” ‘100 mm’ is the “maximum level of fatigue that may be perceived.” Mean score of VAS fatigue in participants were reported.|Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12|The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication. Data allowing the evaluation of fatigue based on VAS was available for 50 participants in TCZ group. The “n” represents the number of participants analyzed at a specified time point.||units on a scale||Standard Deviation|Mean
695038|NCT01394276|Secondary|Mean Score of Disease Activity Based on 28 Joint Count in Participants on Monotherapy With Tocilizumab|The DAS28 is an evaluation index of RA. DAS28 applies a mathematical formula based on the following parameters: 1. Tender joints count (28 joints), 2. Swollen joints count (28 joints), 3.ESR or CRP measurement, 4. Participant’s judgment on his own overall health status expressed by a VAS and calculates total score of 0 to approximately 10. The DAS28 scale ranges from 0 to 10, where scores below 2.6 indicate best disease control, scores above 5.1 indicate worse disease control, higher scores represent higher disease activity and negative change from baseline score indicates improvement. The response to therapy is defined according to the disease activity detected, compared to the previous clinical evaluation.|Baseline (Month 0), Month 1, Month 2, Month 4, Month 6, and Month 12|The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication. Data allowing the evaluation of disease activity based on 28 joints count was available for 93 participants in TCZ group.||units on a scale||Standard Deviation|Mean
695039|NCT01394276|Primary|Percentage of Participants Achieving Disease Remission After 6 Months of Treatment|Disease remission is defined as a DAS28 score < 2.6. The DAS28 is an evaluation index of RA. DAS28 applies a mathematical formula based on the following parameters: 1. Tender joints count (28 joints), 2. Swollen joints count (28 joints), 3. ESR or CRP measurement, 4. Participant’s judgment on his own overall health status expressed by a VAS and calculates total score of 0 to approximately 10. The DAS28 scale ranges from 0 to 10, where scores below 2.6 indicate best disease control, scores above 5.1 indicate worse disease control, higher scores represent higher disease activity and negative change from baseline score indicates improvement. The response to therapy is defined according to the disease activity detected, compared to the previous clinical evaluation. Percentage of participants with disease remission was reported.|Up to 12 months|The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication. Data allowing the evaluation of disease remission was available for 226 participants in TCZ group.||percentage of participants|||Number
695040|NCT01394276|Primary|Percentage of Participants Achieving Low Disease Activity After 6 Months of Treatment|Low disease activity is defined as a disease activity score based on 28 joint count (DAS28) score lesser or equal to (</=) 3.2. The DAS28 is an evaluation index of RA. DAS28 applies a mathematical formula based on the following parameters: 1. Tender joints count (28 joints), 2. Swollen joints count (28 joints), 3. Erythrocyte sedimentation rate (ESR) or C reactive protein (CRP) measurement, 4. Participant’s judgement on his own overall health status expressed by a visual analogue scale (VAS). The DAS28 scale ranges from 0 to 10, where scores below 2.6 indicate best disease control, scores above 5.1 indicate worse disease control, higher scores represent higher disease activity and negative change from baseline score indicates improvement. Percentage of participants with low disease activity was reported.|Up to 12 months|The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication. Data allowing the evaluation of low disease activity was available for 226 participants in TCZ group.||percentage of participants|||Number
695041|NCT01394250|Secondary|Comparison of the Face, Legs, Activity, Cry, Consolability Scale (FLACC) Score Immediately After IV Cannulation Between Groups|The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0–10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2. The FLACC score was completed immediately after IV cannulation by a member of the clinical care team who was not part of the study. During initial trial design, the goal was to collect FLACC score pre and post cannulation; however, it was decided prior to enrollment that FLACC score would not be collected pre cannulation, only post.|Up to 5 minutes after IV Cannulation|Analysis population includes only subjects whose first intravenous (IV) cannulation attempt was successful.||units on a scale||95% Confidence Interval|Median
695042|NCT01394250|Primary|Change From Baseline in Faces Pain Scale Revised (FPS-R) at 30 Minutes After IV Cannulation|The Faces Pain Scale Revised (FPS-R) is numerical self-report measure of pain intensity developed for children to score the sensation of pain from 0-10. Pictures of 6 cartoon faces ranging from neutral expression of “no pain” (0) to “very much pain” (10).|Baseline and 30 minutes|Analysis population includes only subjects whose first intravenous (IV) cannulation attempt was successful.||units on a scale||95% Confidence Interval|Mean
695043|NCT01394185|Primary|Marijuana Self-administration - Drug Vs Money Choice|Participants will be able to self-administer cannabis cigarettes (weighing about 0.8 grams and with about 6% THC) in 5 discrete choices each day between one cannabis cigarette and $1. The number of cannabis cigarettes chosen (and subsequently self-administered) is the primary study endpoint|12-day Dronabinol maintenance period|||Cannabis Cigarettes Chosen||Standard Error|Mean
695044|NCT01394185|Primary|Marijuana Self-administration - Progressive Ratio|Participants will be able to self-administer cannabis cigarettes (weighing about 0.8 grams and with about 6% THC) under a progressive ratio schedule. The number of progressive ratios completed (and thus, cannabis cigarettes consumed) is the primary study endpoint|12-day Dronabinol maintenance period|||Progressive Ratios Completed||Standard Error|Mean
695045|NCT01394159|Secondary|Technical Failure|Malfunction of the needle during endoscopic ultrasound-guided sampling of the pancreatic mass lesion before a diagnosis is achieved|6 months|||participants|||Number
695046|NCT01394159|Secondary|Diagnosis Achieved With the Needle||6 months|||participants|||Number
695047|NCT01394159|Primary|Compare the Median Number of Passes Required to Establish a Diagnosis||6 months|||No. of passes for diagnosis||Inter-Quartile Range|Median
695048|NCT01393964|Other Pre-specified|Geometric Mean Apparent Volume of Distribution (Vz) of Elotuzumab Following Cycle 1, Day 1 Dose Administration - Grouping by Cockcroft-Gault Creatinine Clearance Method|The quantification of elotuzumab in human serum was performed using validated ELISA. Cycle 1, day 1 sample times for all participants: 0 hour (h) pre-dose, end of infusion, 30 minutes (min) post end of infusion, 2 h, 4 h , and 24 h post end of infusion. Trough samples were obtained in subsequent cycles and at 30 day and 60 day follow-up visits at end of treatment. ESRD had 2 additional samples: immediately prior to and immediately after dialysis. Vz was measured in mL per kilogram body weight (mL/kg). PK parameter renal function group assignment criteria differed slightly from the criteria for safety and efficacy analyses (specifically for the SRI group). PK criteria: All participants with at least one pretreatment value ≥ 90 mL/min were assigned to the NRF group. All those with at least one pretreatment value < 30 mL/min were assigned to the SRI group. All those with a screening diagnosis of ESRD, were assigned to the ESRD group.|Day 1 of Cycle 1 to 28 days post dose|The analyses of PK parameters were conducted by renal functions as determined by CrCl C-G method in those participants who were treated with at least one dose of study drug and had evaluable pre- and post-treatment values.||mL/kg||Geometric Coefficient of Variation|Geometric Mean
695049|NCT01393964|Other Pre-specified|Geometric Mean Total Body Clearance (CLT) of Elotuzumab Following Cycle 1, Day 1 Dose Administration - Grouping by Cockcroft-Gault Creatinine Clearance Method|The quantification of elotuzumab in human serum was performed using validated ELISA. Cycle 1, day 1 sample times for all participants: 0 hour (h) pre-dose, end of infusion, 30 minutes (min) post end of infusion, 2 h, 4 h , and 24 h post end of infusion. Trough samples were obtained in subsequent cycles and at 30 day and 60 day follow-up visits at end of treatment. ESRD had 2 additional samples: immediately prior to and immediately after dialysis. CLT was measured in mL per hour per kilogram body weight (mL/h/kg). PK parameter renal function group assignment criteria differed slightly from the criteria for safety and efficacy analyses (specifically for the SRI group). PK criteria: All participants with at least one pretreatment value ≥ 90 mL/min were assigned to the NRF group. All those with at least one pretreatment value < 30 mL/min were assigned to the SRI group. All those with a screening diagnosis of ESRD, were assigned to the ESRD group.|Day 1 of Cycle 1 to 28 days post dose|The analyses of PK parameters were conducted by renal functions as determined by CrCl C-G method in those participants who were treated with at least one dose of study drug and had evaluable pre- and post-treatment values.||mL/h/kg||Geometric Coefficient of Variation|Geometric Mean
695050|NCT01393964|Other Pre-specified|Median Time to Maximal Concentration (Tmax) of Elotuzumab Following Cycle 1, Day 1 Dose Administration - Grouping by Cockcroft-Gault Creatinine Clearance Method|The quantification of elotuzumab in human serum was performed using validated ELISA. Cycle 1, day 1 sample times for all participants: 0 hour (h) pre-dose, end of infusion, 30 minutes (min) post end of infusion, 2 h, 4 h , and 24 h post end of infusion. Trough samples were obtained in subsequent cycles and at 30 day and 60 day follow-up visits at end of treatment. ESRD had 2 additional samples: immediately prior to and immediately after dialysis. Tmax was measured in hours (h). PK parameter renal function group assignment criteria differed slightly from the criteria for safety and efficacy analyses (specifically for the SRI group). PK criteria: All participants with at least one pretreatment value ≥ 90 mL/min were assigned to the NRF group. All those with at least one pretreatment value < 30 mL/min were assigned to the SRI group. All those with a screening diagnosis of ESRD, were assigned to the ESRD group.|Day 1 of Cycle 1 to 28 days post dose|The analyses of PK parameters were conducted by renal functions as determined by CrCl C-G method in those participants who were treated with at least one dose of study drug and had evaluable pre- and post-treatment values.||h||Full Range|Median
695051|NCT01393964|Other Pre-specified|Mean Terminal-phase Elimination Half-life (T-Half) of Elotuzumab Following Cycle 1, Day 1 Dose Administration - Grouping by Cockcroft-Gault Creatinine Clearance Method|The quantification of elotuzumab in human serum was performed using validated ELISA. Cycle 1, day 1 sample times: 0 hour (h) pre-dose, end of infusion, 30 minutes (min) post end of infusion, 2 h, 4 h , and 24 h post end of infusion. Trough samples were obtained in subsequent cycles and at 30 day and 60 day follow-up visits at end of treatment. ESRD had 2 additional samples: immediately prior to and immediately after dialysis. T-Half was measured in hours (h). PK parameter renal function group assignment criteria differed slightly from the criteria for safety and efficacy analyses (specifically for the SRI group). PK criteria: All participants with at least one pretreatment value ≥ 90 mL/min were assigned to the NRF group. All those with at least one pretreatment value < 30 mL/min were assigned to the SRI group. All those with a screening diagnosis of ESRD, were assigned to the ESRD group.|Day 1 of Cycle 1 to 28 days post dose|The analyses of PK parameters were conducted by renal functions as determined by CrCl C-G method in those participants who were treated with at least one dose of study drug and had evaluable pre- and post-treatment values.||h||Standard Deviation|Mean
695052|NCT01393964|Secondary|Number of Participants With Worst Toxicity Grade Chemistry Laboratory Tests|Sodium high (H) Gr 1:>ULN - 150; Gr 2: >150 – 155; Gr 3: >155 – 160; Gr 4: >160 mmol/L; Sodium low(L) Gr 1:<LLN – 130; Gr 3: <130 – 120; Gr 4: <120 mmol/L. Potassium (H) Gr 1: >ULN – 5.5; Gr 2: >5.5 – 6.0; Gr 3: > 6.0 – 7.0; Gr 4: >7.0 mmol/L; Potassium (L) Gr 1: <LLN – 3.0; Gr 2: <LLN – 3.0; Gr 3: < 3.0 – 2.5; Gr 4: <2.5 mmol/L. Bicarbonate Gr1: 16-<LLN, Gr2: 11-16, Gr3, 8-11, Gr4: <8 milliequivalents per liter (mEq/L). Phosphorus Gr 1: 2.5 - <LLN, Gr2 2.0-<2.5, Gr3: 1.0-<2.0, Gr4: <1.0. Calcium (L) Gr 1: <LLN to 8.0; Gr2: 7.0 – 8.0; Gr3: 6.0-7.0; Gr 4: <6.0 mg/dL; calcium (H) Gr1:>ULN – 11.5, Gr2:>11.5 – 12.5, Gr3: 12.5 – 13.5, Gr4: >13.5.|From first dose (Day 1) to last dose plus 60 days (Assessed up to July 2016, approximately 54 months)|All participants who received at least one dose of study treatment (at least one dose of any drug) were summarized.||participants|||Number
695059|NCT01393899|Secondary|Tofacitinib Plasma Concentration by Nominal Post-Dose Sampling Time and Tofacitinib Dose|Plasma samples were collected from participants for the determination of tofacitinib concentrations. Only samples from tofacitinib-treated participants were subsequently analyzed. Plasma concentration data are summarized by nominal sample collection times specified in the protocol, and actual sample collection times may be different.|Pre-dose, 20 minutes, 40 minutes, 1 hour and 2 hours post-dose at Weeks 12 and 26/early termination visit|Pharmacokinetic analysis set - included all participants who received at least 1 dose of study medication and had at least 1 measurable plasma concentration. n=number of observations above lower limit of quantification.||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
700133|NCT00036738|Secondary|Overall Survival|Number of patients surviving up to five years post-transplant.|Assessed up to 5 years||09/2018||||
695053|NCT01393964|Secondary|Number of Participants With Worst Toxicity Grade Renal and Liver Function Laboratory Tests|NCI CTCAE, version 3.0 was used to measure toxicity scale. Lower Limits of Normal (LLN). Upper Limits of Normal (ULN). Alanine transaminase (ALT); Aspartate aminotransferase (AST); Alkaline phosphatase (ALP). ALT Grade (Gr)1:>1.0 to 2.5*ULN; Gr 2: >2.5 to 5.0*ULN; Gr 3: >5.0 to 20.0*ULN; Gr 4: >20.0*ULN. AST Gr 1: >1.0 to 2.5*ULN; Gr 2: >2.5 to 5.0*ULN; Gr 3: >5.0 to 20.0*ULN; Gr 4: >20.0*ULN. Total bilirubin Gr 1: >1.0 to 1.5*ULN; Gr 2: >1.5 to 3.0*ULN; Gr 3: >3.0 to 10..0*ULN; Gr 4: >10.0.0*ULN. ALP (U/L) Gr1:>1.0 to 2.5*ULN, Gr2:>2.5 to 5.0*ULN, Gr3:>5.0 to 20.0*ULN, Gr4:>20.0*ULN. Albumin (low) Gr 1:<LLN to 3 grams per deciliter (g/dL); Gr 2: <3.0 – 2.0 g/L; Gr 3: < 2 g/dL. Creatinine Gr 1: >1 – 1.5*baseline (BL)to >ULN – 1.5*ULN; Gr 2: >1.5 – 3.0*BL to > 1.5 – 3.0*ULN; Gr 3: >3.0*BL to > 3.0 – 6.0*ULN; Gr 4: >6.0*ULN.|From first dose (Day 1) to last dose plus 60 days (Assessed up to July 2016, approximately 54 months)|All participants who received at least one dose of study treatment (at least one dose of any drug) were summarized.||participants|||Number
695054|NCT01393964|Secondary|Number of Participants With Worst Toxicity Grade Hematology Laboratory Tests|National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 was used to measure toxicity scale. Lower Limits of Normal (LLN). Hemoglobin Gr 1:<LLN to 10.0 g/dL, Gr 2:<10.0 to 8.0 g/dL, Gr 3:<8.0 to 6.5 g/dL, Gr 4:<6.5 g/dL. Lymphocytes absolute (abs) Gr 1: <1.5 to 0.8 *10^3 c/µL, Gr 2 <0.8 to 0.5 *10^3 c/µL, Gr 3: <0.5 to 0.2 *10^3 c/µL, Gr 4: <0.2*10^3 c/µL. Neutrophils abs: Gr 1:<LLN to 1.5*10^9/L, Gr 2:<1.5 to 1.0*10^9/L, Gr 3:<1.0 to 0.5*10^9/L, Gr 4:<0.5*10^9/L. Platelet count Gr 1:LLN to 75.0*10^9/L, Gr 2:<75.0 to 50.0*10^9/L, Gr 3:<50.0 to 25.0*10^9/L, Gr 4:<25.0 to 10^9/L. Leukocytes Gr 1:<LLN to 3.0 *10^3 c/µL, Gr 2; <3.0 to 2.0 *10^3 c/µL, Gr 3: <2.0 to 1.0 *10^3 c/µL, Gr 4: <1.0 *10^3 c/µL.|From first dose (Day 1) to last dose plus 60 days (Assessed up to July 2016, approximately 54 months)|All participants who received at least one dose of study treatment (at least one dose of any drug) were summarized.||participants|||Number
695055|NCT01393964|Secondary|Number of Participants With Persistent Elotuzumab Anti-drug Antibodies (ADA) and Number of Participants ADA Positive at Cycle 2 Pre-dose.|Serum samples were evaluated for the presence of ADAs using a validated bridging electrochemiluminescence (ECL) immunoassay. Samples in: Cycle 1, Day 1 0 h (pre-dose), Cycle 2, Day 1(Study Day 29), 0 h (pre-dose; 672 h post-dose), Cycle 3, Day 1, 0 h and in cycle thereafter, at end of study/discontinuation, and at 30 and 60 day follow up visits post treatment. ADA Positive Participant: baseline negative with at least one ADA positive sample at any time after initiation of treatment or baseline positive with at least one ADA positive sample at any time after initiation of treatment with a titer 9-fold greater than the baseline; Persistent Positive: ADA positive at 2 or more sequential timepoints at least 12 weeks apart; Last Sample Positive: Not persistent positive and ADA Positive Sample in the last sampling timepoint; Other Positive: not persistent positive with ADA negative sample in the last sampling; ADA Negative: no ADA positive sample after the initiation of treatment.|From first dose (Day 1) to last dose plus 60 days, up to Primary Endpoint (June 2014), approximately 2 years|All participants with baseline ADA result and at least one on-treatment ADA result.||participants|||Number
695056|NCT01393964|Secondary|Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Who Died|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|From first dose (Day 1) to last dose plus 60 days (Assessed up to July 2016, approximately 54 months)|All participants who received at least one dose of study treatment (at least one dose of any drug) were summarized.||participants|||Number
695057|NCT01393964|Primary|Geometric Mean Area Under Serum Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration AUC(0-T) and From Time Zero Extrapolated to Infinite Time AUC(INF) of Elotuzumab Following Cycle 1, Day 1 - Grouping by C-G CrCl Method|The quantification of elotuzumab in human serum was performed using validated ELISA. Cycle 1, day 1 sample times for all participants: 0 hour (h) pre-dose, end of infusion, 30 minutes (min) post end of infusion, 2 h, 4 h , and 24 h post end of infusion. Trough samples were obtained in subsequent cycles and at 30 day and 60 day follow-up visits at end of treatment. ESRD participants had 2 additional sample times: immediately prior to and immediately after dialysis. AUC was measured in µg*h/mL. PK parameter renal function group assignment criteria differed slightly from the criteria for safety and efficacy analyses (specifically for the SRI group). PK criteria: All participants with at least one pretreatment value ≥ 90 mL/min were assigned to the NRF group. All those with at least one pretreatment value < 30 mL/min were assigned to the SRI group. All those with a screening diagnosis of ESRD, were assigned to the ESRD group|Day 1 of Cycle 1 to 28 days post dose|The analyses of primary endpoint of PK parameters were conducted by renal functions as determined by CrCl C-G method in those participants who were treated with at least one dose of study drug and had evaluable pre- and post-treatment values.||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
695058|NCT01393964|Primary|Geometric Mean Maximum Observed Serum Concentration (Cmax) of Elotuzumab Following Cycle 1, Day 1 Dose Administration - Grouping by Cockcroft-Gault Creatinine Clearance Method|The quantification of elotuzumab in human serum was performed using a validated Enzyme-linked immunoassay (ELISA). Cycle 1, day 1 sample times for all participants: 0 hour (h) pre-dose, end of infusion, 30 minutes (min) post end of infusion, 2 h, 4 h , and 24 h post end of infusion. Trough samples were obtained in subsequent cycles and at 30 day and 60 day follow-up visits at end of treatment. ESRD had 2 additional samples: immediately prior to and immediately after dialysis. Cmax was measured in micrograms per milliliter (µg/mL). Pharmacokinetic (PK) parameter renal function group assignment criteria differed slightly from the criteria for safety and efficacy analyses (specifically for the SRI group). PK criteria: All participants with at least one pretreatment value ≥ 90 mL/min were assigned to the NRF group. All those with at least one pretreatment value < 30 mL/min were assigned to the SRI group. All those with a screening diagnosis of ESRD, were assigned to the ESRD group.|Day 1 of Cycle 1 to 28 days post dose|The analyses of primary endpoint of PK parameters were conducted by renal functions as determined by CrCl C-G method in those participants who were treated with at least one dose of study drug and had evaluable pre- and post-treatment values.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
695482|NCT01389882|Secondary|Dynamic Compliance|Dynamic Compliance measured by a ventilator for 4 hours with each ventilator mode|four hours|"The analysis was per protocol. 19 patients who had completed the study was used for the analysis."||mL/cmH2O||Standard Deviation|Mean
695063|NCT01393899|Secondary|C-Reactive Protein (CRP) by Week|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline and Weeks 4, 8, 12, 20 and 26|mFAS||milligram per liter (mg/L)||Standard Deviation|Mean
695064|NCT01393899|Secondary|Percentage of Participants Achieving a Steroid-Free Clinical Remission at Week 26 of the Maintenance Phase - Among Participants on Steroids at A3921084 Baseline|Clinical remission was a CDAI <150 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general wellbeing, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body eight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.|Week 26|mFAS who were on steroids at A3921084 Baseline||Percentage of participants||80% Confidence Interval|Number
695065|NCT01393899|Secondary|Kaplan-Meier Estimate of the Rate of Time to Relapse|Time to relapse was defined as increase in CDAI of more than (>)100 points from the maintenance phase baseline and a CDAI score of >220 points, or an increase to or above the baseline CDAI score in A3921083. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general wellbeing, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.|Weeks 4, 8 12, 20 and 26|mFAS, n=number of participants remaining at risk||Percent Probability||80% Confidence Interval|Number
695066|NCT01393899|Secondary|Change From Baseline in CDAI Score by Week|CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general wellbeing, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity|Weeks 4, 8, 12, 20 and 26|mFAS||Score on a scale||Standard Deviation|Mean
695067|NCT01393899|Secondary|CDAI Score by Week|CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general wellbeing, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity|Baseline and Weeks 4, 8, 12, 20 and 26|mFAS||Score on a scale||Standard Deviation|Mean
695068|NCT01393899|Secondary|Percentage of Participants With Sustained Clinical Response-100 (Defined as Having at Least a Clinical Response-100 at Both Weeks 20 and 26 From the A3921083 Baseline) in the Maintenance Phase|Clinical response-100 was defined as a reduction in CDAI score from baseline of at least 100 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.|Weeks 20 and 26|mFAS||Percentage of participants||80% Confidence Interval|Number
695069|NCT01393899|Secondary|Percentage of Participants in Sustained Clinical Remission (Defined as Being in Clinical Remission at Both Weeks 20 and 26) in the Maintenance Phase|Clinical remission was a CDAI score <150 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for anti-diarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.|Weeks 20 and 26|mFAS||Percentage of participants||80% Confidence Interval|Number
695070|NCT01393899|Secondary|Percentage of Participants in Clinical Remission at Week 4, 8, 12, 20 and 26 Among Participants in Remission at Baseline of Maintenance Study|Clinical remission was a CDAI score <150 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for anti-diarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.|Weeks 4, 8, 12, 20 and 26|mFAS||Percentage of participants||80% Confidence Interval|Number
695071|NCT01393899|Secondary|Percentage of Participants in Clinical Remission at Weeks 4, 8, 12, 20 and 26|Clinical remission was a CDAI score <150 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for anti-diarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.|Weeks 4, 8, 12, 20 and 26|mFAS||Percentage of participants||80% Confidence Interval|Number
695072|NCT01393899|Secondary|Percentage of Participants Achieving Clinical Response-100 at Weeks 4, 8, 12, 20 and 26|Clinical response-100 was defined as a reduction in CDAI score from baseline of at least 100 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for anti-diarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.|Weeks 4, 8, 12, 20 and 26|mFAS||Percentage of participants||80% Confidence Interval|Number
695073|NCT01393899|Secondary|Percentage of Participants With Clinical Response-100 or Clinical Remission at Weeks 4, 8, 12 and 20|Clinical response-100 was defined as a reduction in CDAI score of at least 100 points from baseline of the parent A3921083 study. Clinical remission was a CDAI score <150 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for anti-diarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.|Weeks 4, 8, 12 and 20|mFAS||Percentage of participants||80% Confidence Interval|Number
695483|NCT01389882|Secondary|Expiratory Tidal Volume|Expiratory tidal volume measured by a ventilator for 4 hours with each ventilator mode|four hours|"The analysis was per protocol. 19 patients who had completed the study was used for the analysis."||mL/Kg||Standard Deviation|Mean
695074|NCT01393899|Primary|Percentage of Participants With Clinical Response-100 (as Defined by a Decrease in Crohn’s Disease Activity Index [CDAI] Score of at Least 100 Points From Baseline) or Clinical Remission (CDAI Score Less Than [<]150) at Week 26|Clinical response-100 was defined as a reduction in CDAI score of at least 100 points from baseline of the parent A3921083 study. Clinical remission was a CDAI score <150 points. CDAI is a composite index consisting of a weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal symptoms, need for anti-diarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant’s diary kept while on study. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.|Week 26|Modified full analysis set (mFAS), defined as all randomized participants who received at least 1 dose of investigational product (ie, active or placebo study medication) in this study and who were randomized into 1 of the tofacitinib (CP-690,550) dose groups in Study A3921083.||Percentage of participants||80% Confidence Interval|Number
695075|NCT01393743|Secondary|Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events as a Measure of Safety and Tolerability of Perampanel in Subjects With Inadequately Controlled PGTC Seizures - (for Core Study)|An Adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered an investigational product. A serious adverse event (SAE) was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening (i.e., the subject was at immediate risk of death from the AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect (in the child of a subject who was exposed to the study drug). In this study, treatment emergent adverse events (TEAEs) (defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.|For each participant, from the first treatment dose till 30 days after the last dose or up to 21 weeks for core study and 142 weeks for extension phase.|The Safety Analysis Set included participants who were randomized to study drug, received at least 1 dose of study drug, and had at least 1 postbaseline safety assessment.||Participants|||Number
695076|NCT01393743|Secondary|Summary of Percent Change From Pre-Perampanel Baseline in Seizure Frequency Per 28 Days - (for Extension Phase)|Efficacy assessments included seizure counts from participant diaries. The percent change in seizure frequency was assessed during the perampanel treatment duration, with the pre-perampanel baseline being used for evaluating the change. The pre-perampanel baseline was defined as follows: 1) for all participants who had been assigned to placebo treatment in the Core Study, the pre-perampanel baseline was computed from all valid seizure diary data during the Core Study, and 2) for participants who had been assigned to perampanel in the Core Study, the pre-perampanel baseline was computed from all valid seizure diary data during the Prerandomization Phase plus the 4 weeks prior to the Prerandomization Phase of the Core Study. The perampanel treatment duration consisted of: 1) the Randomization Phase of the Core Study plus the Extension Phase for participants assigned to perampanel in the Core Study, and 2) the Extension Phase for participants assigned to placebo in the Core Study.|Weeks: 1 to 13, 14 to 26, 27 to 39, 40 to 52, 53 to 65, 66 to 78, 79 to 91, 92 to 104, 105 to 117, 118 to 130, 131 to 143, greater than or equal to 144|Full Analysis Set, which comprised all participants who were eligible to participate in the Extension Phase, received at least 1 dose of perampanel in this phase, and had baseline seizure frequency data and at least 1 observation of valid seizure diary data during the perampanel treatment duration.||Percent change in seizure frequency||Full Range|Median
695077|NCT01393743|Secondary|Percent Change From Core Study Prerandomization Phase in Primary Generalized Tonic-Clonic (PGTC) Seizure Frequency Per 28 Days - (for Extension Phase)|Week 1 began on the date of first dose of the perampanel treatment regardless of whether it occurred in the Core Study or Extension Phase and continued to and included the date of the last dose of perampanel in the Extension Phase. For any given analysis window and seizure type(s), a 50% responder from Core Study Randomization is a participant whose seizure frequency per 28 days for that seizure type(s) during that analysis window is 50% to 100% lower than his or her Core Study Prerandomization baseline seizure frequency per 28 days for that same seizure type(s). In Part B of the Extension Phase (after Visit 15), the seizure diary is only completed for days on which a seizure occurred and missing days were imputed as non-seizure days.|Date of first dose of study drug to date of last dose of study drug in the Extension Phase|Full analysis set included all participants who were eligible to participate in the Extension Phase, received at least 1 dose of perampanel in this phase, and had baseline seizure frequency data and at least 1 observation of valid seizure diary data during the perampanel treatment duration.||Percent change in PGTC seizure frequency||Full Range|Median
695078|NCT01393743|Secondary|50% Responder Rate for Primary Generalized Seizure Subtype During Maintenance Period - LOCF - (for Core Study)|Primary generalized seizure subtype included absence and myoclonic seizures. A responder was a participant who experienced a 50% or greater reduction in seizure frequency per 28 days during Maintenance - (LOCF) from prerandomization. The data was presented as the percentage of participants.|Baseline (4 or 8 weeks) and Maintenance (13 weeks)|Only a subset of participants in the Full Analysis Set who experienced these seizure types during the Prerandomization Phase of the study were included in this analysis.||Percentage of participants|||Number
695079|NCT01393743|Secondary|50% Responder Rate for All Seizures During Maintenance-LOCF - (for Core Study)|All seizures included PGTC, myoclonic, absence and all other seizures that occur during the study. A responder was a participant who experienced a 50% or greater reduction in seizure frequency per 28 days during Maintenance- LOCF from prerandomization. The data was presented as percentage of participants.|Baseline (4 or 8 weeks) and Maintenance (13 weeks)|Full Analysis Set||Percentage of participants|||Number
695125|NCT01393613|Secondary|Percentage of Participants With Discontinuation Rate for Lack of Efficacy at Week 6.|Participants discontinued for lack of efficacy during the trial were reported here.|Week 6|Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation.||percentage of participants|||Number
695484|NCT01389882|Secondary|Minute Ventilation|Minute ventilation measured by a ventilator for 4 hours with each ventilator mode|four hours|"The analysis was per protocol. 19 patients who had completed the study was used for the analysis."||L/min/Kg||Standard Deviation|Mean
695080|NCT01393743|Secondary|Median Percent Change in Primary Generalized Seizure Subtype Frequency Per 28 Days During the Titration and Maintenance Periods (Combined) Relative to Baseline (Prerandomization) - (for Core Study)|Seizure frequency per 28 days was derived from the information recorded in the participant diaries. PGTC seizure frequency per 28 days was calculated as the number of PGTC seizures divided by the number of days in the interval and multiplied by 28. The percent change in seizure frequency relative to baseline (prerandomization) for primary generalized seizure subtype (myoclonic and absence) per 28 days during the Titration and Maintenance Periods combined was analyzed.|Baseline (4 or 8 weeks), Titration (4 weeks), and Maintenance (13 weeks)|Full Analysis Set||Percent Change||Full Range|Median
695081|NCT01393743|Secondary|Median Percent Change in All Seizure Frequency Per 28 Days During the Titration and Maintenance Periods (Combined) Relative to Baseline (Prerandomization) - (for Core Study)|Seizure frequency per 28 days was derived from the information recorded in the participant diaries. PGTC seizure frequency per 28 days was calculated as the number of PGTC seizures divided by the number of days in the interval and multiplied by 28. The percent change in seizure frequency relative to baseline (prerandomization) for all seizures (PGTC, myoclonic, absence and all other seizures that occur during the study) per 28 days during the Titration and Maintenance Periods combined was analyzed.|Baseline (4 or 8 weeks), Titration (4 weeks), and Maintenance (13 weeks)|Full Analysis Set||Percent Change||Full Range|Median
695082|NCT01393743|Primary|50% Responder Rate in Primary Generalized Tonic-Clonic Seizure Frequency Per 28 Days Relative to the Core Study Prerandomization Phase – (for Extension Phase)|Responder rate was defined as the percentage of participants who experienced a 50% or greater reduction in PGTC and total seizure frequency during treatment per 28 days relative to baseline (responder). Week 1 began on the date of first dose of the perampanel treatment regardless of whether it occurred in the Core Study or Extension Phase and continued to and included the date of the last dose of perampanel in the Extension Phase. For any given analysis window and seizure type(s), a 50% response from Core Study Prerandomization is a participant whose seizure frequency per 28 days for that seizure type(s) during that analysis window is 50% to 100% lower than his or her Core Study Prerandomization baseline seizure frequency per 28 days for that same seizure type(s). In Part B of the Extension Phase (after Visit 15), the seizure diary is only completed for days on which a seizure occurred and missing days were imputed as non-seizure days.|Week 1 of perampanel treatment to date of last dose of perampanel in the Extension Phase|The Extension Phase FAS included participants who were eligible to participate in the Extension Phase, received at least 1 dose of study drug in this phase, and had baseline seizure frequency data and at least 1 observation of valid seizure diary data during study drug treatment duration.||Percentage of participants|||Number
695083|NCT01393743|Primary|50% Responder Rate for Primary Generalized Tonic Clonic Seizure During Maintenance - LOCF - (for Core Study)|A responder was a participant who experienced a 50% or greater reduction in seizure frequency per 28 days during Maintenance-last observation carried forward (LOCF) from prerandomization. The data was presented as the percentage of participants.|Baseline (4 or 8 weeks) and Maintenance (13 weeks)|Full Analysis Set included all randomized participants who received as least 1 dose of study drug and had any postbaseline seizure frequency data. Last observation carried forward (LOCF).||Percentage of participants|||Number
695084|NCT01393743|Primary|Median Percent Change in Primary Generalized Tonic Clonic Seizure Frequency (PGTC) Per 28 Days During the Titration and Maintenance Periods (Combined) Relative to Baseline (Prerandomization) - (for Core Study)|Seizure frequency per 28 days was derived from the information recorded in the participant diaries. PGTC seizure frequency per 28 days (as determined from participant diaries) was calculated as the number of PGTC seizures divided by the number of days in the interval and multiplied by 28. The percent change from baseline in PGTC seizure was analyzed over the Titration and Maintenance Periods combined, while baseline was defined as seizure frequency per 28 days based on all valid diary data during the Prerandomization Phase.|Baseline (4 or 8 weeks), Titration (4 weeks), and Maintenance (13 weeks)|The Full Analysis Set included participants who were randomized to study drug, received at least 1 dose of study drug, and had any postbaseline seizure frequency data during the Randomization Phase.||Percent change||Full Range|Median
695085|NCT01393730|Secondary|Change in Circulating Tumor Cells (CTCs) Levels|CTCs were measured based on established methods.|Pairs of patients' samples were evaluated at baseline and time of progression. In this study cohort, participants were followed up to 48 months for this endpoint.|Data were not collected for this secondary endpoint.|||||
695086|NCT01393730|Secondary|Change in Serum Androgen Levels|Serum androgen levels measured based on established methods. The change from baseline to progression was calculated for each participant.|Pairs of patients' samples for androgen analyses were obtained at baseline and at time of progression. In this study cohort, participants were followed up to 48 months for this endpoint.|The analysis dataset is comprised of all treated patients.||ng/dl||Inter-Quartile Range|Median
695087|NCT01393730|Secondary|Presence of AR Amplification|Presence of AR amplification was measured by established methods.|Patients' samples were evaluated at baseline and every 12 weeks on treatment. In this study cohort, participants were followed up to 48 months for this endpoint.|The analysis dataset is comprised of all evaluable patients.||Participants|||Count of Participants
695088|NCT01393730|Secondary|Time to Progression (TTP)|TTP based on the Kaplan-Meier method is defined as the duration of time from study entry to documented first observation of progressive disease (PD). Per RECIST 1.0 for target lesions, PD is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or appearance of new lesions. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|Disease evaluation occurred every 12 weeks while patients were receiving treatment. In this study cohort, participants were followed up to 48 months for this endpoint.|The analysis dataset is comprised of all treated patients.||Months||95% Confidence Interval|Median
695126|NCT01393613|Secondary|Percentage of Participants With Response at Week 6.|The response rate was defined as reduction of ≥30% from Baseline in PANSS Total Score or CGI-I score of 1 or 2.|Week 6|Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation.||percentage of participants|||Number
695485|NCT01389882|Secondary|Mean Airway Pressure|mean airway pressure measured by a ventilator for 4 hours with each ventilator mode|four hours|"The analysis was per protocol. 19 patients who had completed the study was used for the analysis."||cmH2O||Standard Deviation|Mean
695089|NCT01393730|Secondary|Best Overall Response|Overall response (OR) rate was defined as achieving partial response (PR) or complete response (CR) based on RECIST 1.0 criteria on treatment. Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.|Disease was evaluated radiologically at baseline and every 12 weeks cycles on treatment. In this study cohort, participants were followed up to 48 months for this endpoint.|The analysis dataset is comprised of all treated patients.||Participants|||Count of Participants
695090|NCT01393730|Secondary|Time to PSA Progression|Time to PSA progression based on the Kaplan-Meier method was defined as the time between registration and documented PSA progression. PSA progression based on Prostate-Specific Antigen Working Group-2 (PSAWG-2) (2008) criteria was an increase of >/=25% and >/= 2 ng/ml after 12 weeks for patients without a PSA decline from baseline and an increase of >/=25% and >/= 2 ng/ml above the nadir, confirmed by a 2nd value 3 weeks or later for patients with a PSA decline from baseline. PSA progression was reported not duration of response.|PSA was measured at baseline and day 1 of every cycle on treatment. In this study cohort, participants were followed up to 48 months for this endpoint.|The analysis dataset is comprised of all treated patients.||months||95% Confidence Interval|Median
695091|NCT01393730|Secondary|Prostate-Specific Antigen (PSA) Response|PSA response was defined as decline of 50% from baseline confirmed by a PSA at least 4 weeks later based on Prostate-specific Antigen Working Group-2 (PSAWG-2) (2008) criteria.|PSA was measured at baseline and day 1 of every cycle on treatment. In this study cohort, participants were followed up to 48 months for this endpoint.|The analysis dataset is comprised of all treated patients.||Participants|||Count of Participants
695092|NCT01393730|Secondary|Change in Serum Levels of Testosterone|Serum testosterone levels were estimated based on established methods. The change from baseline to progression was calculated for each participant.|Samples for testosterone analyses were obtained at baseline and at time of progression. In this study cohort, participants were followed up to 48 months for this endpoint.|The analysis dataset is comprised of all treated patients.||ng/dL||Inter-Quartile Range|Median
695093|NCT01393730|Primary|Number of Participants With Androgen Receptor (AR) Related Mutations|AR related mutation was defined as presence of T878A mutation. Expression of T878A was measured by established methods.|Pairs of patients samples were evaluated at baseline and time of progression. In this study cohort, participants were followed up to 48 months for this endpoint.|The analysis dataset is comprised of all patients evaluable for AR mutation.||Participants|||Count of Participants
695094|NCT01393704|Secondary|Total Operation Time|Time from incision to end of surgery|5 minutes postoperatively|||minutes||Standard Deviation|Mean
695095|NCT01393704|Secondary|Number of Participants With Peri-operative Complications|Intra or post-operative complications (including but not limited to need for blood transfusion or adverse effect related to Vasopressin).|8 weeks postoperatively|||Participants|||Count of Participants
695096|NCT01393704|Primary|Estimating Blood Loss at the End of Myomectomy - Suction Canister Estimated Blood Loss Calculation|To evaluate whether volume of dilute Vasopressin administered during minimally-invasive myomectomy affects blood loss, three parameters will be collected to assess this outcome. Objective calculation of blood loss via the measurement of suction canister fluid (ml) was one of these. The calculation for estimated blood loss will be as follows: EBL = [total suction canister volume] - [volume of irrigation used] - [volume of vasopressin solution injected /2].|5 minutes post-operatively|Due to practice pattern differences among sites, there was some missing data for suction canister blood loss calculation. In these cases, total suction canister volume and/or volume of irrigation used were not measured.||millileters||Standard Deviation|Mean
695097|NCT01393704|Primary|Estimating Blood Loss at the End of Myomectomy - Surgeon Estimated Blood Loss|To evaluate whether volume of dilute Vasopressin administered during minimally-invasive myomectomy affects blood loss, three parameters will be collected to assess this outcome: Subjective surgeon's estimate of blood loss (ml) was one measurement method.|5 minutes post-operatively|||millileters||Standard Deviation|Mean
695098|NCT01393704|Primary|Estimating Blood Loss at the End of Myomectomy - Hematocrit Percentage|To evaluate whether volume of dilute Vasopressin administered during minimally-invasive myomectomy affects blood loss, three parameters will be collected to assess this outcome. Pre and post-operative hematocrit change (%) was one of these measurement methods.|5 minutes post-operatively|Due to practice pattern differences among sites, there was some missing data for the change in hematocrit variable, where the hematocrit either pre-operatively or post-operatively was not collected.||hematocrit percentage||Standard Deviation|Mean
695099|NCT01393626|Secondary|Change From Baseline EQ-5D VAS Scores at Week 8/ET Visit Using ANCOVA|"EQ-5D is a participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeters (mm) (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Adjusted means were derived from the ANCOVA model with baseline value as a covariate, treatment group & prior use of anti-TNF alpha treatments as factors.
The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size."|Baseline, Week 8/ET visit|FAS. N is the number of subjects in the analysis set, Number of Participants Analyzed is the maximum number of subjects with non-missing data.||mm||Standard Error|Mean
695100|NCT01393626|Secondary|EQ-5D Visual Analogue Scale (VAS) Scores at Baseline and Week 8/ET Visit|EQ-5D is a participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeters (mm) (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Week 8/ET visit|FAS. N is the number of subjects in the analysis set, Number of Participants Analyzed is the maximum number of subjects with non-missing data.||mm||Standard Deviation|Mean
695486|NCT01389882|Primary|Peak Inspiratory Pressure|peak inspiratory pressure measured by a ventilator for 4 hours with each ventilator mode|four hours|"The analysis was per protocol. 19 patients who had completed the study was used for the analysis."||cmH2O||Standard Deviation|Mean
695101|NCT01393626|Secondary|Change From Baseline EQ-5D Utility Scores at Week 8/ET Visit Using ANCOVA|"EQ-5D is a participant rated questionnaire to assess health-related QoL via a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain & discomfort, anxiety & depression; 1 = better health state (no problems); 3 = worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain. Score is transformed to a total score ranging from -0.594 to 1.000; higher score indicates better health state. Adjusted means were derived from the ANCOVA model with baseline value as a covariate, treatment group & prior use of anti-TNFα treatments as factors.
The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size."|Baseline, Week 8/ET visit|FAS. N is the number of subjects in the analysis set, Number of Participants Analyzed is the number of subjects with non-missing data.||Score on a Scale||Standard Error|Mean
695102|NCT01393626|Secondary|EuroQoL 5 Dimensions Questionnaire (EQ-5D) Utility Scores at Baseline and Week 8/ET Visit|"EQ-5D is a participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range from -0.594 to 1.000; a higher score indicates a better health state."|Baseline, Week 8/ET visit|FAS. N is the number of subjects in the analysis set, Number of Participants Analyzed is the maximum number of subjects with non-missing data.||Score on a Scale||Standard Deviation|Mean
695103|NCT01393626|Secondary|Change From Baseline SF-36 Component and Domain Scores at Week 8/ET Visit Using ANCOVA|"The component and domain scores were scored using the US 1998 general population norms. The resulting norm-based T scores for both the SF-36 version 2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. Higher scores indicate better health-related QOL.
Adjusted means were derived from the ANCOVA model with baseline value as a covariate, treatment group and prior use of anti-TNF alpha treatments as factors.
The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size."|Baseline, Week 8/ET visit|FAS. N is the number of subjects in the analysis set, Number of Participants Analyzed is the maximum number of subjects with non-missing data.||Score on a Scale||Standard Error|Mean
695104|NCT01393626|Secondary|Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit|The component and domain scores were scored using the United States (US) 1998 general population norms. The resulting norm-based T scores for both the SF-36 version 2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. Higher scores indicate better health-related QOL.|Baseline, Week 8/ET visit|FAS. N is the number of subjects in the analysis set, Number of Participants Analyzed is the maximum number of subjects with non-missing data.||Score on a Scale||Standard Deviation|Mean
695105|NCT01393626|Secondary|Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category|The IBD Patient Reported Treatment Impact Modified (PRTI) questionnaire comprises 3 individual questions administered to the participant: participant satisfaction with study treatment; participant preference for study drug over prior treatment (this question on participant preference for study drug is prefaced by a simple question of previous treatment/s for IBD received in order to place the preference question into context) and participant willingness to re-use the study treatment again. Each of these questions (except the question on previous treatment, which is informational only) is scored on a 5 point Likert scale. PSA = Patient Satisfaction Assessment; PPTA = Patient Previous Treatment Assessment; PPA = Patient Preference Assessment; PWA = Patient Willingness Assessment.|Week 8/ET visit|FAS. Number of Participants Analyzed is the number of participants in the analysis set.||Percentage of Participants|||Number
695106|NCT01393626|Secondary|Percentage of Participants With ≥16 Point Increase From Baseline in IBDQ Total Score at Week 8/ET Visit|The IBDQ is a psychometrically validated PRO instrument for measuring disease-specific QOL in participants with IBD. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). Total score is the sum of each item score, and ranged from 32 to 224 with a higher score indicating a better QOL. Positive change in total score indicated improvement in QOL.|Week 8/ET visit|FAS. Number of Participants Analyzed is the number of participants in the analysis set.||Percentage of Participants|||Number
695107|NCT01393626|Secondary|Percentage of Participants With an IBDQ Total Score of Greater Than or Equal to (≥) 170 at Week 8/ET Visit|The IBDQ is a psychometrically validated PRO instrument for measuring disease-specific QOL in participants with IBD. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). Total score is the sum of each item score, and ranged from 32 to 224 with a higher score indicating a better QOL. Positive change in total score indicated improvement in QOL.|Week 8/ET visit|FAS||Percentage of Participants|||Number
695108|NCT01393626|Secondary|Change From Baseline IBDQ Total Score and Domain Scores (Bowel Function, Emotional Status, Systemic Symptoms, and Social Function) at Week 8/ET Visit Using Analysis of Covariance (ANCOVA)|"IBDQ is a validated PRO instrument for measuring QOL in IBD consisting of 32 items scored from 1 (worst response) to 7 (best response). 32 items are grouped into 4 domains scored as follows: bowel symptoms 10 - 70; systemic symptoms 5 - 35; emotional function 12 - 84; social function 5 - 35. For each domain, higher score indicates better QOL. Total score is the sum of each item score, & ranged from 32 to 224 with a higher score indicating better QOL. Positive change in total score indicated improvement in QOL.
Adjusted means were derived from an ANCOVA model with baseline value as covariate, treatment group & prior use of anti-tumor necrosis factor (TNF) alpha (α) treatments as factors.
The 15 mg BID treatment group was closed to further enrolment early in the study by Protocol Amendment 5 after only 16 participants were enrolled in this group. Therefore, the efficacy analysis was not performed for this group as the results may be difficult to interpret due to the small sample size."|Baseline, Week 8/ET visit|FAS. N is the number of subjects in the analysis set, Number of Participants Analyzed is the maximum number of subjects with non-missing data.||Score on a scale||Standard Error|Mean
695109|NCT01393626|Secondary|Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score and Domain Scores (Bowel Function, Emotional Status, Systemic Symptoms, and Social Function) at Baseline and Week 8/ET Visit|The IBDQ is a psychometrically validated patient reported outcome (PRO) instrument for measuring disease-specific quality of life (QOL) in participants with inflammatory bowel disease (IBD). IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). The 32 items are grouped into 4 domains: bowel function, emotional status, systemic symptoms and social function. The 4 domains are scored as follows: bowel symptoms 10 to 70; systemic symptoms 5 to 35; emotional function 12 to 84; social function 5 to 35. For each domain, a higher score indicates better QOL. Total score is the sum of each item score, and ranged from 32 to 224 with a higher score indicating a better QOL. Positive change in total score indicated improvement in QOL.|Baseline, Week 8/ET visit|FAS. N is the number of subjects in the analysis set, Number of Participants Analyzed is the number of subjects with non-missing data.||Score on a scale||Standard Deviation|Mean
695110|NCT01393626|Secondary|Tofacitinib Plasma Concentrations From 0 to 2 Hours Post Dose on Day 1 and at Week 8/Early Termination (ET) Visit|Plasma samples were collected from participants for the determination of tofacitinib concentrations. Only samples from tofacitinib-treated participants were subsequently analyzed. Plasma concentration data are summarized by nominal sample collection times specified in the protocol, and actual sample collection times may be different.|Pre-dose, 20 minutes, 40 minutes, 1 hour, and 2 to 3 hours post-dose on Day 1 and Week 8/ET visit|Pharmacokinetic analysis set - included all participants who received at least one dose of study medication and had at least one measurable plasma concentration. n is the number of observations (i.e. non-missing concentrations) at each timepoint.||nanograms per milliliter||Standard Deviation|Mean
695111|NCT01393626|Secondary|Calprotectin Fecal Concentrations at Weeks 2, 4, and 8|Fecal calprotectin is an inflammatory marker for the gastrointestinal tract and considered as a measurement of neutrophil migration to the gastrointestinal tract. Higher values indicate more serious inflammation.|Weeks 2, 4, and 8|FAS. Number of Participants Analyzed is the number of participants in the analysis set, n is the number of participants with non-missing data.||mg per kilogram (mg/kg)||Standard Deviation|Mean
695112|NCT01393626|Secondary|C-Reactive Protein (CRP) Serum Concentrations at Weeks 2, 4, and 8|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Weeks 2, 4, and 8|FAS. Number of Participants Analyzed is the number of participants in the analysis set, n is the number of participants with non-missing data.||Milligrams per liter (mg/L)||Standard Deviation|Mean
695113|NCT01393626|Secondary|CDAI Scores at Weeks 2, 4, and 8|CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.|Weeks 2, 4, and 8|FAS. Number of Participants Analyzed is the number of participants in the analysis set, n is the number of participants with non-missing data.||Score on a scale||Standard Deviation|Mean
695114|NCT01393626|Secondary|Percentage of Participants Achieving Either Clinical Response-100 or Clinical Remission (CDAI<150) at Weeks 2, 4, and 8|"Clinical response-100 was defined as a reduction in CDAI score from baseline of at least 100 points. Clinical remission was a CDAI < 150 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.
The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size."|Baseline, Weeks 2, 4, and 8|FAS, participants with missing values were treated as non-responders.||Percentage of Participants||95% Confidence Interval|Number
695115|NCT01393626|Secondary|Percentage of Participants Achieving Clinical Response-100 (as Defined by a Decrease in CDAI Score of at Least 100 Points From Baseline) at Weeks 2, 4, and 8|"Clinical response-100 was defined as a reduction in CDAI score from baseline of at least 100 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.
The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size."|Baseline, Weeks 2, 4, and 8|FAS, participants with missing values were treated as non-responders.||Percentage of Participants||95% Confidence Interval|Number
695116|NCT01393626|Secondary|Percentage of Participants Achieving Clinical Response-70 (as Defined by a Decrease in CDAI Score of at Least 70 Points From Baseline) at Weeks 2, 4, and 8|"Clinical response-70 was defined as a reduction in CDAI score from baseline of at least 70 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.
The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size."|Baseline, Weeks 2, 4, and 8|FAS, participants with missing values were treated as non-responders.||Percentage of Participants||95% Confidence Interval|Number
695177|NCT01392677|Secondary|Proportion of Participants With HbA1c Value < 7.0% at Week 24 (LOCF)|To compare the proportion of subjects achieving a therapeutic glycemic response, defined as HbA1c <7.0%, at week 24 (LOCF) between dapagliflozin and placebo|Baseline to week 24|Full Analysis Set, participants with non-missing baseline and week 24 (LOCF) values||Percentage of participants||95% Confidence Interval|Least Squares Mean
695117|NCT01393626|Secondary|Percentage of Participants in Clinical Remission (CDAI <150) at Weeks 2 and 4|"Clinical remission was a CDAI <150 points. CDAI is a composite index consisting of a weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant’s diary kept while on study. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.
The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size."|Weeks 2 and 4|FAS, participants with missing values were treated as non-responders.||Percentage of Participants||95% Confidence Interval|Number
695118|NCT01393626|Primary|Percentage of Participants in Clinical Remission (as Defined by a Crohn’s Disease Activity Index [CDAI] Score of Less Than [<] 150 Points) at Week 8|"Clinical remission was a CDAI < 150 points. CDAI is a composite index consisting of a weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant’s diary kept while on study. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.
The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size."|Week 8|Full analysis set (FAS) – included all randomized participants who received at least 1 dose of investigational product and who had a qualified CDAI score calculated using the hematocrit value measured at baseline visit (Day 1). Participants with missing values were treated as non-responders.||Percentage of Participants||95% Confidence Interval|Number
695119|NCT01393613|Secondary|Mean Change From Baseline to Week 6 in PANSS Marder Factor Scores: Anxiety and Depression Score.|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The anxiety/depression factor score is the sum of score from the 4 items on the anxiety/depression subscale (range: 4 - best possible outcome to 28 - worst possible outcome).|Baseline, Weeks 1, 2, 3, 4, 5, and 6|Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation.||Units on a scale||Standard Error|Least Squares Mean
695120|NCT01393613|Secondary|Mean Change From Baseline to Week 6 in PANSS Marder Factor Scores: Uncontrolled Hostility and Excitement Score.|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The uncontrolled hostility/excitement factor score is the sum of score from the 4 items on the uncontrolled hostility/excitement subscale (range: 4 - best possible outcome to 28 - worst possible outcome).|Baseline, Weeks 1, 2, 3, 4, 5, and 6|Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation.||Units on a scale||Standard Error|Least Squares Mean
695121|NCT01393613|Secondary|Mean Change From Baseline to Week 6 in PANSS Marder Factor Scores: Disorganized Thought Score.|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The disorganized thoughts factor score is the sum of score from the 7 items on the disorganized thoughts subscale (range: 7 - best possible outcome to 49 - worst possible outcome).|Baseline, Weeks 1, 2, 3, 4, 5, and 6|Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation.||Units on a scale||Standard Error|Least Squares Mean
695122|NCT01393613|Secondary|Mean Change From Baseline to Week 6 in PANSS Marder Factor Scores: Negative Symptoms Score.|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The negative factor score is the sum of the 7 items of the negative subscale (range: 8 - best possible outcome to 56 - worst possible outcome).|Baseline, Weeks 1, 2, 3, 4, 5, and 6|Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation.||Units on a scale||Standard Error|Least Squares Mean
695123|NCT01393613|Secondary|Mean Change From Baseline to Week 6 in PANSS Marder Factor Scores: Positive Symptoms Score.|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The positive factor score is the sum of the 8 components of the positive symptoms scale (range: 8 - best possible outcome to 56 - worst possible outcome).|Baseline, Weeks 1, 2, 3, 4, 5, and 6|Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation.||Units on a scale||Standard Error|Least Squares Mean
695124|NCT01393613|Secondary|Mean Change From Baseline to Week 6 in PANSS Excited Component (PEC) Score.|The PEC score consisted of five PANSS items: excitement (P4), hostility (P7), tension (G4), uncooperativeness (G8), and poor impulse control (G14). Each of the items were rated on a scale of 1 (absent) to 7 (extreme). The PEC scores ranged from 5 (not present) to 35 (extremely severe).|Baseline, Weeks 1, 2, 3, 4, 5, and 6|Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation.||Units on a scale||Standard Error|Least Squares Mean
695127|NCT01393613|Secondary|Mean Clinical Global Impression-Improvement (CGI-I) Scale Score at Week 6.|The efficacy of trial medication was rated for each participant using the CGI-I. The study physician would rate the participant's total improvement whether or not it is due entirely to drug treatment. All responses were compared to the participant's condition at Baseline prior to the first dose of double-blind study medication. Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.|Week 6|Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation.||Units on a scale||Standard Deviation|Mean
695128|NCT01393613|Secondary|Mean Change From Baseline to Week 6 in PANSS Negative Subscale Score.|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS negative subscale score ranged from 7 (best possible outcome) to 49 (worst possible outcome).|Baseline, Weeks 1, 2, 3, 4, 5, and 6|Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation.||Units on a scale||Standard Error|Least Squares Mean
695129|NCT01393613|Secondary|Mean Change From Baseline to Week 6 in PANSS Positive Subscale Score.|PANSS consisted of three subscales: a total of 30 symptom constructs. For each construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS positive subscale score was the sum of the rating scores for the 7 positive scale items from the PANSS panel. The 7 positive symptom constructs are delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS positive subscale score ranged from 7 (best possible outcome) to 49 (worst possible outcome). The analysis of secondary endpoints was conducted if both comparisons of brexpiprazole 4 mg/day vs placebo and brexpiprazole 2 mg/day vs placebo of the primary endpoint were significant. Although only the comparison of brexpiprazole 4 mg/day vs placebo met the gatekeeping threshold in the primary analysis, statistical testing for the other doses was reported for information.|Baseline, Weeks 1, 2, 3, 4, 5, and 6|Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation.||Units on a scale||Standard Error|Least Squares Mean
695130|NCT01393613|Secondary|Mean Change From Baseline to Week 6 in Personal and Social Performance (PSP) Score.|PSP is a validated clinician-rated scale that measures personal and social functioning in 4 domains: socially useful activities (e.g. work and study), personal and social relationships, self-care, and disturbing and aggressive behaviors. Impairment in each of these domains was rated as absent, mild, manifest, marked, severe, or very severe. These ratings were then converted to a total score based on a 100-point scale using algorithms to identify the appropriate 10-point interval, and the rater’s judgment to determine the total score within the 10-point interval. Participants with a PSP total score of 71 to 100 were considered to have mild functional difficulty. Scores of 31 to 70 represented manifest disabilities of various degrees and ratings of 1 to 30 indicated minimal functioning that required intense support and/or supervision.|Baseline, Week 3 and Week 6|Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation.||Units on a scale||Standard Error|Least Squares Mean
695131|NCT01393613|Secondary|Mean Change From Baseline to Week 6 in Clinical Global Impression-Severity (CGI-S) Score.|Severity of illness for each participant was rated using the CGI-S, which was the key secondary efficacy endpoint. To perform this assessment, the study physician answered the following question: “Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?” Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.|Baseline, Weeks 1, 2, 3, 4, 5, and 6|Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation.||Units on a scale||Standard Error|Least Squares Mean
695132|NCT01393613|Primary|Mean Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score.|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline, Weeks 1, 2, 3, 4, 5, and 6|Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation.||Units on a scale||Standard Error|Least Squares Mean
695133|NCT01393600|Post-Hoc|Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score for Combined NBI-98854 Dose Groups (Excluding 1 Site)|Severity of TD symptoms assessed by AIMS dyskinesia total score (sum of items 1 through 7), as assessed by blinded central AIMS video raters. The AIMS Total Dyskinesia Score rates a total of 7 items, rating involuntary movement from 0 (no dyskinesia) to 4 (severe dyskinesia). Items 1 through 7 include facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). The AIMS dyskinesia total score for Items 1-7 ranges from 0 to 28; a higher score reflects increased severity.|Day 15 and 29, averaged|Intent to treat (ITT) analysis set (all subjects who received at least 8 doses of study drug during Treatment Period 1 and had an AIMS dyskinesia total score value for Day 15).||units on a scale||Standard Error|Least Squares Mean
695134|NCT01393600|Secondary|Clinical Global Impression - Global Improvement of TD (CGI-TD)|Clinician's perspective of the participant's overall improvement of TD symptoms over time. The CGI-TD is based on a 7-point scale (range: 1=very much improved to 7=very much worse).|Day 15 and 29, averaged|Intent to treat (ITT) analysis set (all subjects who received at least 8 doses of study drug during Treatment Period 1 and had an AIMS dyskinesia total score value for Day 15).||units on a scale||Standard Error|Mean
700134|NCT00036738|Secondary|Leukemia-free Survival|Number of patients surviving in CR up to five years post-transplant.|Assessed up to 5 years||09/2018||||
695135|NCT01393600|Primary|Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score|Severity of TD symptoms assessed by AIMS dyskinesia total score (sum of items 1 through 7), as assessed by blinded central AIMS video raters. The AIMS Total Dyskinesia Score rates a total of 7 items, rating involuntary movement from 0 (no dyskinesia) to 4 (severe dyskinesia). Items 1 through 7 include facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). The AIMS dyskinesia total score for Items 1-7 ranges from 0 to 28; a higher score reflects increased severity.|Day 15 and 29, averaged|Intent to treat (ITT) analysis set (all subjects who received at least 8 doses of study drug during Treatment Period 1 and had an AIMS dyskinesia total score value for Day 15).||units on a scale||Standard Error|Least Squares Mean
695136|NCT01393444|Secondary|Number of Participants Able to Achieve Direct Brain Control of Assistive Devices Using an Electrocorticography (ECoG)-Based Brain-computer Interface System|Participants will be asked to perform, attempt, or imagine performing motor tasks while their brain activity is recorded in order to observe the changes in neural activity during each task.|Up to 29 days of device implantation|Individuals with limited or no ability to use one or both hands due to cervical spinal cord injury, brachial plexus injury, brainstem stroke, muscular dystrophy, cerebral palsy or amyotrophic lateral sclerosis (ALS) or other motor neuron disease.||participants|||Number
695137|NCT01393444|Primary|Number of Participants Able to Successfully Control of a Variety of External Devices Using Neural Data Recorded With ECoG|Participants will attempt to control devices such as computer cursors, virtual reality environments and assistive devices such as hand orthoses or surface functional electrical stimulators using their brain activity recorded through ECoG.|Up to 29 days of device implantation|Individuals with limited or no ability to use one or both hands due to cervical spinal cord injury, brachial plexus injury, brainstem stroke, muscular dystrophy, cerebral palsy or amyotrophic lateral sclerosis (ALS) or other motor neuron disease.||participants|||Number
695138|NCT01393132|Secondary|Tear Film Break up Time|"Tear film break up time (TFBUT) was measured to evaluating the quality of tear at 56 day (+28 day follow up).
The tear film break-up time is defined as the interval between the last complete blink and the first appearance of a dry spot, or disruption in the tear film.
Range : >10 seconds is thought to be normal, <5 seconds low (with high likelihood of dry eye symptoms)."|Days 56 (+28 day follow up)|||seconds||Standard Deviation|Mean
695139|NCT01393132|Secondary|Ocular Discomfort Index|"Dry eye causes ocular discomfort, which is measured using a Ocular Surface Disease Index at 56 day (+28 day followup).
(Symptomatic improvement using the validated Ocular Surface Disease Index (OSDI).
The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision.
For every question, participants check a score between 0 and 4, where 0 equals none of the time and 4 equals all of the time.
OSDI scores are calculated according to: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4].
The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability."|Days 56 (+28 day follow up)|||units on a scale||Standard Deviation|Mean
695140|NCT01393132|Secondary|Corneal Fluorescein Staining|"Ocular surface irregularity as measured by Slit Lamp Examination (SLE) with fluorescein dye staining of the cornea at days 56 (+28 day follow up).
The scale used to determine the difference in corneal fluorescein staining is the Oxford scale. (The Oxford Scale measures corneal fluorescein staining) Corneal staining type was assessed by the investigator for each of 5 regions of the cornea, i.e., four quadrants plus central. The five regions were summed, for a maximum score of 25. A higher score represents greater disability."|Days 56 (+28 day follow up)|||units on a scale||Standard Deviation|Mean
695141|NCT01393132|Primary|Safety|Sum of adverse events observed at Day 1, Day 14, Day 28 and Day 56. Measurable by Intra-ocular pressure (IOP) by applanation tonometry, Complete ophthalmologic evaluation including fundoscopy, An adverse event (baseline and all subsequent study visits).|Day 1, Day 14, Day 28 and Day 56|||event|||Number
695142|NCT01393106|Secondary|Idelalisib Trough and Peak Plasma Concentration at Week 4|Plasma samples were collected predose (trough) and 1.5 hours postdose (peak). The minimum and maximum value among participants sampled at each time point are presented. Results of less than the lower limit of quantitation (ie, 5 ng/mL) were treated as zero prior to the achievement of the first quantifiable concentration and as missing otherwise.|Predose and 1.5 hours postdose at Week 4|Participants in the ITT Analysis Set with available data were analyzed.||ng/mL|||Number
695143|NCT01393106|Secondary|Compliance With Study Drug Dosing as Assessed by Accounting for Used and Unused Drug||Up to Week 110|ITT Analysis Set||number of doses||Standard Deviation|Mean
695144|NCT01393106|Secondary|Overall Safety Profile of Idelalisib|"The overall safety of idelalisib was assessed as the percentage of participants experiencing adverse events (AEs; Serious AEs, Grade ≥ 3 AEs, AEs related to idelalisib, and AEs leading to discontinuation of idelalisib), clinically significant abnormal electrocardiograms (ECG), and laboratory abnormalities. Clinically significant abnormalities in ECG were as determined by the investigator."|Up to Week 110|ITT Analysis Set||percentage of participants|||Number
695145|NCT01393106|Secondary|Changes in the Plasma Concentrations of Disease-associated Chemokines and Cytokines||Up to Week 110|This analysis was not conducted due to discrepancies with the transfer of samples.|||||
695146|NCT01393106|Secondary|Changes in Performance Status as Documented Using the Karnofsky Performance Criteria for Participants ≥ 16 Years of Age and the Lansky Performance Criteria for Participants < 16 Years of Age|Changes in performance status were assessed using the Karnofsky performance criteria for participants ≥ 16 years of age and the Lansky performance criteria for participants < 16 years of age. Since there were no participants < 16 years of age, only the Karnofsky performance criteria were used. The change in Karnofsky performance status was reported as the best (highest change score) and worst (lowest change score) change from baseline using the Karnofsky performance criteria. The Karnofsky score classifies patients according to their functional impairment. Scores are on a scale from 0-100, the lower the score, the worse the survival for most serious illnesses.|Baseline and up to Week 110|Participants in the ITT Analysis Set with available data were analyzed.||units on a scale||Standard Deviation|Mean
695178|NCT01392677|Secondary|Adjusted Mean Change From Baseline in Total Body Weight|To compare the change from baseline in total body weight to week 24 (LOCF) between dapagliflozin and placebo|Baseline to week 24|Full Analysis Set, participants with non-missing baseline and week 24 (LOCF) values||kg||95% Confidence Interval|Least Squares Mean
701092|NCT00058825|Secondary|Donor Chimerism Engraftment of Greater Than 50%|Number of patients that engrafted who showed a chimerism (donor cells) of greater than 50% in the first 30 days|30 days|Patients engrafted||participants|||Number
695147|NCT01393106|Secondary|Changes in Health-related Quality of Life as Reported Using the Functional Assessment of Cancer Therapy: Lymphoma (FACT-Lym) Questionnaire|"Change in health-related quality of life was reported by participants using the FACT-Lym questionnaire assessment tool. Results are presented as the mean (SD) best change from baseline in FACT-Lym total score, which was defined as the highest change score (improvement) after baseline.
The FACT-Lym total score is on a scale from 0-168, with higher scores associated with a better quality of life."|Baseline and up to Week 110|FACT-Lym Evaluable Analysis Set: participants who had sufficient baseline and on-study measurements to provide interpretable results for this endpoint.||units on a scale||Standard Deviation|Mean
695148|NCT01393106|Secondary|Time to Treatment Failure|Time to treatment failure (TTF) was defined as the interval from the start of idelalisib treatment to the earlier of the first documentation of disease progression, the permanent cessation of idelalisib therapy due to an adverse event, or death from any cause.|Up to Week 110|No data are presented because time to treatment failure data were not collected.|||||
695149|NCT01393106|Secondary|Progression Free Survival|Progression free survival (PFS) was defined as the interval from the start of idelalisib treatment to the earlier of the first documentation of disease progression or death from any cause.|Up to Week 110|ITT Analysis Set||months||95% Confidence Interval|Median
695150|NCT01393106|Secondary|Overall Survival|Overall survival was defined as the time from start of idelalisib treatment to death from any cause.|Up to Week 110|ITT Analysis Set||months||95% Confidence Interval|Median
695151|NCT01393106|Secondary|Time to Response|Time to response (TTR) was defined as the interval from the start of idelalisib treatment to the first documentation of CR or PR.|Up to Week 110|Responding Analysis Set||months||Full Range|Median
695152|NCT01393106|Secondary|Change From Baseline in Fluorodeoxyglucose (FDG) Uptake in Lymph Nodes as Assessed by Positron-emission Tomography (PET)||Up to Week 110|An analysis of changes in FDG uptake by the tumor was not conducted due to unavailability of lymph node biopsy samples.|||||
695153|NCT01393106|Secondary|Percent Change From Baseline in the Sum of the Product of the Greatest Perpendicular Diameters (SPD) of Target Lymph Nodes as Documented Radiographically||Baseline, Week 8, Week 48, and up to Week 110|ITT Analysis Set||percent change in SPD||Full Range|Median
695154|NCT01393106|Secondary|Duration of Response|Duration of response (DOR) was defined as the interval from the first documentation of PR or CR to the earlier of the first documentation of disease progression or death from any cause.|Up to Week 110|Responding Analysis Set: participants who achieved a best response of CR or PR.||months||95% Confidence Interval|Median
695155|NCT01393106|Primary|Overall Response Rate|"Overall response rate (ORR) was assessed based on the International Working Group Revised Response Criteria for Malignant Lymphoma (Cheson, 2007), and was defined as the proportion of participants achieving a complete response (CR) or partial response (PR) as assessed by the investigator.
CR was defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease.
PR was defined as a ≥ 50% reduction in the sum of the products of the longest perpendicular diameters of all index lesions, with no new lesions."|Up to Week 110|Intent-to-treat (ITT) Analysis Set: participants who received at least one dose of study drug.||percentage of participants||95% Confidence Interval|Number
695156|NCT01392742|Secondary|Percentage of Participants With Virological Response|The Virological response at the end of treatment was defined as the percentage of participants with undetectable HCV RNA, HCV test (based on a single last undetectable HCV RNA PCR falling in the 4 weeks' time window at end of treatment), is basically the sum of participants with SVR and with relapse.|4 weeks after EOT (up to Week 76)|PP population.||percentage of participants|||Number
695157|NCT01392742|Secondary|Cumulative Ribavirin Dose in Participants With SVR by HCV Genotype|SVR was defined as undetectable HCV RNA 24 weeks after end of treatment.|Up to Week 72|"PP population. Here number of participants analyzed included participants evaluable for the outcome measure and n signified evaluable participants for specific HCV genotype."||mg||Full Range|Mean
695158|NCT01392742|Secondary|Cumulative PEG-IFN Alfa-2a Dose in Participants With SVR by HCV Genotype|SVR was defined as undetectable HCV RNA 24 weeks after end of treatment.|Up to Week 72|"PP population. Here number of participants analyzed included participants evaluable for the outcome measure and n signified evaluable participants for specific HCV genotype."||µg||Full Range|Mean
695159|NCT01392742|Secondary|Duration of Treatment in Participants With SVR by HCV Genotype|SVR was defined as undetectable HCV RNA 24 weeks after end of treatment.|Up to Week 72|"PP population. Here number of participants analyzed included participants evaluable for the outcome measure and n signified evaluable participants for specific HCV genotype."||days||Full Range|Mean
695160|NCT01392742|Secondary|Predictive Power Values of Host-, Virus- and Treatment-related Factors and Virological Response|Predictive value determined the relationship of host factors to virological response. Host factors included; RVR (EVR for Week 12), gender, liver fibrosis, HCV genotype, height and treatment duration for Week 4 after EOT excluding HCV genotype at Week 12 EOT. RVR was defined as having undetectable HCV RNA 4 weeks after start of treatment and EVR was defined as having undetectable HCV RNA 12 weeks after start of treatment.|Week 4 and 12|PP population. Here “number of participants analyzed” included participants who were evaluable for this outcome measure||predictive value|||Number
695161|NCT01392742|Secondary|Correlation of SVR With Early Virological Response (EVR)|Correlation of SVR with EVR was based on 3 symmetric measures; Kendall's tau-b, Kendall's tau-c and Gamma. SVR was defined as undetectable HCV RNA 24 weeks after end of treatment. EVR was defined as having undetectable HCV RNA 12 weeks after start of treatment.|Up to 24 weeks after EOT (up to Week 96)|"PP population. Here number of participants analyzed included participants who were evaluable for this outcome measure."||correlation coefficient|||Number
695162|NCT01392742|Secondary|Correlation of SVR With Rapid Virological Response (RVR)|Correlation of SVR with RVR was based on 3 symmetric measures; Kendall's tau-b, Kendall's tau-c and Gamma. SVR was defined as undetectable HCV RNA 24 weeks after end of treatment. RVR was defined as having undetectable HCV RNA 4 weeks after start of treatment.|Up to 24 weeks after EOT (up to Week 96)|"PP population. Here number of participants analyzed included participants who were evaluable for this outcome measure."||correlation coefficient|||Number
695179|NCT01392677|Secondary|Adjusted Mean Change From Baseline in FPG|To compare the change from baseline in fasting plasma glucose (FPG) to week 24 (LOCF) between dapagliflozin and placebo|Baseline to week 24|Full Analysis Set, participants with non-missing baseline and week 24 (LOCF) values||mg/dL||95% Confidence Interval|Least Squares Mean
695163|NCT01392742|Secondary|Percentage of Participants With Positive Predictive Value on SVR at Week 12|Predictive value determined the relationship of the virological response at specified time to the total response. Positive predicted value= number of true positives/( number of true positives+ number of false positives). SVR was defined as undetectable HCV RNA 24 weeks after end of treatment. Percentage of participants who showed positive predictive value in treatment naive and those who failed previous treatment with interferon were reported.|Week 12|"PP population. Here number of participants analyzed included participants evaluable for the outcome measure and n signified evaluable participants for specific group."||percentage of participants|||Number
695164|NCT01392742|Secondary|Percentage of Participants With Positive Predictive Value on SVR at Week 4|Predictive value determined the relationship of the virological response at specified time to the total response. Positive predicted value= number of true positives/(number of true positives+ number of false positives). SVR was defined as undetectable HCV RNA 24 weeks after end of treatment. Percentage of participants who showed positive predictive value in treatment naive and those who failed previous treatment with interferon were reported.|Week 4|"PP population. Here number of participants analyzed included participants who were evaluable for this outcome measure and n signified evaluable participants for specific group."||percentage of participants|||Number
695165|NCT01392742|Primary|Percentage of Participants Who Were Non-Responders|Non-responders were those participants who had not reached аn undetectable HCV RNA during the treatment period.|Up to 24 weeks after EOT (up to Week 96)|PP population.||percentage of participants|||Number
695166|NCT01392742|Primary|Percentage of Participants With Relapse|Relapse was define as аn undetectable HCV RNA during the treatment period, but without such during the follow-up.|Up to 24 weeks after EOT (up to Week 96)|PP population.||percentage of participants|||Number
695167|NCT01392742|Primary|Percentage of Participants With Sustained Virological Response (SVR)|SVR was defined as undetectable Hepatitis C Virus Ribonucleic Acid (HCV RNA) 24 weeks after completion of the actual treatment period (a single last undetectable HCV RNA Polymerase Chain Reaction [PCR] measured greater than or equal to >=140 days post-treatment).|24 weeks after End of treatment (EOT) (up to Week 96)|Per Protocol (PP) population included all participants without any protocol violation.||percentage of participants|||Number
695168|NCT01392703|Secondary|Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests|Criteria for normal: bilirubin (0.2 to 1.3 mg/dL); lactate dehydrogenase (101 to 227 U/L); eosinophils (0.06 to 0.87*103 c/μL); erythrocytes (4.2 to 5.8*10^6 c/μL). Participants were required to fast for a minimum of 4 hours prior to the collection of specimens for clinical laboratory tests at screening and for at least 8 hours prior to collection on Day -1. Marked abnormalities were reported for the treatment regiment that participants received just prior to clinical laboratory testing.|Day -1, Screening, and Day 9 of current treatment regimen|All participants who received at least 1 dose of any study drug.||Participants|||Number
695169|NCT01392703|Secondary|Number of Participants With Clinically Significant Changes in Vital Signs or Electrocardiogram (ECG) Findings|Blood pressure and heart rate were measured after the participant had been seated quietly for at least 5 minutes. ECG findings were recorded after the participant had been supine for at least 5 minutes. Clinically significant as reported by principal investigator.|Day -1, Screening, and Days 1, 5, 9 and 10 (at study discharge)|All participants who received at least 1 dose of any study drug.||Participants|||Number
695170|NCT01392703|Secondary|Number of Participants With at Least 1 Adverse Event (AE), With at Least 1 Treatment-related AE, Who Discontinued Due to AEs, and With at Least 1 Serious Adverse Event (SAE)|An AE is any new untoward medical occurrence or worsening of a preexisting medical condition in a patient or clinical investigation participant who has received an investigational (medicinal) product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE is an untoward medical event that at any dose results in death, persistent or significant disability/incapacity; is life-threatening or a congenital anomaly/birth defect; or requires or prolongs hospitalization; is an important medical event that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention.|Continually from enrollment through Day 9 and at study discharge on Day 10|All participants who received at least 1 dose of any study drug.||Participants|||Number
695171|NCT01392703|Secondary|Half-life of Dasatinib||Days 1-2, Days 5-6, and Days 9-10|All participants who received at least 1 dose of any study drug and had pharmacokinetic data available.||Hours||Standard Deviation|Mean
695172|NCT01392703|Secondary|Time of Maximum Observed Plasma Concentration (Tmax) of Dasatinib|Single-dose pharmacokinetic parameters, such as Tmax, were derived using noncompartmental methods from plasma dasatinib concentration-time data.|Days 1-2, Days 5-6, and Days 9-10|All participants who received at least 1 dose of any study drug and had pharmacokinetic data available.||Hours||Full Range|Median
695173|NCT01392703|Primary|Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC[0-INF]) of Dasatinib|Single-dose pharmacokinetic parameters, such as AUC(0-INF) were derived using noncompartmental methods from plasma dasatinib concentration-time data.|Days 1-2, Days 5-6, and Days 9-10|All participants who received at least 1 dose of any study drug and had pharmacokinetic data available.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
695174|NCT01392703|Primary|Area Under the Plasma Concentration-time Curve From Zero to the Last Time of the Last Quantifiable Concentration (AUC[0-T])of Dasatinib|Single-dose pharmacokinetic, such as AUC(0-T),parameters were derived using noncompartmental methods from plasma dasatinib concentration-time data.|Days 1-2, Days 5-6, and Days 9-10|All participants who received at least 1 dose of any study drug and had pharmacokinetic data available.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
695175|NCT01392703|Primary|Maximum Observed Concentration (Cmax) of Dasatinib|Single-dose pharmacokinetic parameters, including Cmax, were derived using noncompartmental methods from plasma dasatinib concentration-time data.|Days 1-2, Days 5-6, and Days 9-10|All participants who received at least 1 dose of any study drug and had pharmacokinetic data available.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
695176|NCT01392677|Secondary|Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure|To compare the change from baseline in seated systolic blood pressure (SBP) to week 8 (LOCF) between dapagliflozin and placebo|Baseline to week 8|Full Analysis Set, participants with non-missing baseline and week 8 (LOCF) values||mmHg||95% Confidence Interval|Least Squares Mean
695180|NCT01392677|Primary|Adjusted Mean Change From Baseline in HbA1c Levels|To compare the change from baseline in HbA1c to week 24 between dapagliflozin 10 mg in combination with metformin and sulfonylurea and placebo in combination with metformin and sulfonylurea.|Baseline to week 24|Full Analysis Set, participants with non-missing baseline and week 24 values||Percent||95% Confidence Interval|Least Squares Mean
695183|NCT01392560|Primary|Change in Glomerular Filtration Rate (GFR) After 8 Weeks of Treatment With Empagliflozin Under Controlled Conditions of Euglycaemia and Hyperglycaemia|The primary endpoint is change in glomerular filtration rate (GFR) after 8 weeks of treatment with empagliflozin under controlled conditions of euglycaemia and hyperglycaemia|Baseline and 8 weeks|Per protocol set for renal (PPS_RENAL) consists of all patients who were treated with study drug and had a baseline measurement and evaluable post-dosing renal data under the clamped hyperglycemia condition for the primary endpoint.||mL/min/1.73 m^2||Standard Error|Mean
695184|NCT01392547|Secondary|Immunogenicity (Inhibitor Development)|Immunogenicity was tested by formation of neutralising antibodies towards vatreptacog alfa and/or FVII. Radioimmunoassay using [125I]-labelled vatreptacog alfa or rFVIIa was used to screen plasma samples for development of anti-drug antibodies|Adverse events were captured from the time of consent to the end of trial visit 1 month (+14 days) after last administration of trial product.|All patients exposed to at least one dose of trial product was included in the safety analysis set. Patients received scheduled doses with rFVIIa, and treatment (rVIIa and vatreptacog alfa) for each bleeding episode.||Subjects|||Number
695185|NCT01392547|Secondary|Number of Adverse Events|Any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Adverse events were captured from the time of consent to 1 month (+14 days) after last administration of trial product.|All patients exposed to at least one dose of trial product was included in the safety analysis set. Patients received scheduled doses with rFVIIa, and treatment (rVIIa and vatreptacog alfa) for each bleeding episode.||events|||Number
695186|NCT01392547|Secondary|Number of Doses of Trial Product Given for Each Acute Bleed||Up to 6 hours after first trial product administration|Patients with ≥1 efficacy data point. 567 bleeds in 69 patients were treated with vatreptacog/rFVIIa in random sequence. Bleeds excluded in case of identical consecutive treatments, use of both trial products, unknown dispensing unit number.||bleeding episodes|||Number
695187|NCT01392547|Secondary|Effective and Sustained Bleeding Control||Up to 48 hours after first trial product administration|Patients with ≥1 efficacy data point. 567 bleeds in 69 patients were treated with vatreptacog/rFVIIa in random sequence. Bleeds excluded in case of identical consecutive treatments, use of both trial products, unknown dispensing unit number.||bleeding episodes|||Number
695188|NCT01392547|Primary|Effective Bleeding Control Defined as no Additional Haemostatic Medication (Other Than Trial Product) Given||Within 12 hours of first trial product administration|Patients with ≥1 efficacy data point. 567 bleeds in 69 patients were treated with vatreptacog/rFVIIa in random sequence. Bleeds excluded in case of identical consecutive treatments, use of both trial products, unknown dispensing unit number.||bleeding episodes|||Number
695189|NCT01392495|Secondary|Medical Resource Utilization||144 weeks|The study terminated early. No statistical analysis was performed on the efficacy outcomes.|||||
695190|NCT01392495|Secondary|Time to Clinical Worsening (TTCW) Endpoints||144 weeks|The study terminated early. No statistical analysis was performed on the efficacy outcomes.|||||
695191|NCT01392495|Secondary|Change From Baseline in the Six Minute Walk Distance (6MWD)||baseline, 144 weeks|The study terminated early. No statistical analysis was performed on the efficacy outcomes.|||||
695192|NCT01392495|Primary|Number of Patients With Adverse Events, Serious Adverse Events and Deaths|Adverse event monitoring was conducted throughout the trial.|144 weeks|Safety Analysis Set: The safety analysis set included all participants who received at least one dose of study drug during the extension and had at least one post-baseline safety assessment.||Participants|||Number
695193|NCT01392378|Secondary|Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): Toddler Dose|An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events for toddler dose were events between toddler dose and up to 1 month (28 to 42 days) after toddler dose that were absent before treatment or that worsened relative to pre-treatment state. Reported non-SAEs included AEs other than SAEs collected using electronic diary (fever, systematic assessment) and events spontaneously collected on case report form at each visit (non-systematic assessment).|Toddler dose up to 1 Month (28 to 42 days) after toddler dose|Safety analysis set toddler dose included all participants who receive toddler dose of 13vPnC or INFANRIX hexa and had AE or temperature data available.||participants|||Number
695194|NCT01392378|Secondary|Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): After the Infant Series|An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events after the infant series were events between 1 month (28 to 42 days) after infant series to toddler dose that were absent before treatment or that worsened relative to pre-treatment state. Reported non-SAEs included AEs other than SAEs spontaneously collected on case report form (non-systematic assessment).|1 Month (28 to 42 days) after infant series Dose 3 up to toddler dose|Safety analysis set Dose 3 included all participants who receive Dose 3 of 13vPnC or INFANRIX hexa in infant series and had AE or temperature data available.||participants|||Number
695195|NCT01392378|Secondary|Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): Infant Series|An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events for infant series were events between infant series Dose 1 and up to 1 month (28 to 42 days) after infant series that were absent before treatment or that worsened relative to pre-treatment state. Reported non-SAEs included AEs other than SAEs collected using electronic diary (fever, systematic assessment) and events spontaneously collected on case report form at each visit (non-systematic assessment).|Baseline up to 1 Month (28 to 42 days) after infant series|Safety analysis set Dose 1 included all participants who receive Dose 1 of 13vPnC or INFANRIX hexa in infant series and had AE or temperature data available.||participants|||Number
695196|NCT01392378|Secondary|Percentage of Participants Reporting Fever Within 4 Days: Toddler Dose|Participants' rectal temperature was collected for 4 days after each vaccination using an electronic diary. Participants' temperature was collected at 6 to 8 hours after vaccination, 6 to 8 hours following that and coincidentally with antipyretic administration for groups receiving antipyretics. Temperature was recorded at bedtime daily for 3 following days (Day 2 to Day 4) and at any time during the 3 days when fever was suspected. The highest temperature for each day was recorded in the e-diary. Incidences of fever were presented in following categories: >=38 but <=39 degree C, >39 but <=40 degree C and >40 degree C.|Within 4 days after toddler dose|Safety analysis set toddler dose: participants who receive toddler dose of 13vPnC or INFANRIX hexa and had AE or temperature data available. ‘N’ (number of participants analyzed) =participants reported yes for >=1 day or no for all days, ‘n’ =participants reporting yes for >=1 day or no for all days for specified event for each arm, respectively.||percentage of participants|||Number
695197|NCT01392378|Secondary|Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 3|Participants' rectal temperature was collected for 4 days after each vaccination using an electronic diary. Participants' temperature was collected at 6 to 8 hours after vaccination, 6 to 8 hours following that and coincidentally with antipyretic administration for groups receiving antipyretics. Temperature was recorded at bedtime daily for 3 following days (Day 2 to Day 4) and at any time during the 3 days when fever was suspected. The highest temperature for each day was recorded in the e-diary. Incidences of fever were presented in following categories: >=38 but <=39 degree C, >39 but <=40 degree C and >40 degree C. Report of fever >40 degrees C after 13vPnC Infant Series Dose 3 was confirmed as data entry error.|Within 4 days after infant series Dose 3|Safety analysis set Dose 3: participants who received Dose 3 of 13vPnC/INFANRIX hexa in infant series and had AE or temperature data available. ‘N’ (number of participants analyzed) =participants reported yes for >=1 day or no for all days, ‘n’=participants reporting yes for >=1 day or no for all days for specified event for each arm respectively.||percentage of participants|||Number
695198|NCT01392378|Secondary|Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 2|Participants' rectal temperature was collected for 4 days after each vaccination using an electronic diary. Participants' temperature was collected at 6 to 8 hours after vaccination, 6 to 8 hours following that and coincidentally with antipyretic administration for groups receiving antipyretics. Temperature was recorded at bedtime daily for 3 following days (Day 2 to Day 4) and at any time during the 3 days when fever was suspected. The highest temperature for each day was recorded in the e-diary. Incidences of fever were presented in following categories: >=38 but <=39 degree C, >39 but <=40 degree C and >40 degree C.|Within 4 days after infant series Dose 2|Safety analysis set Dose 2: participants who received Dose 2 of 13vPnC/INFANRIX hexa in infant series and had AE or temperature data available. ‘N’ (number of participants analyzed) =participants reported yes for >=1 day or no for all days, ‘n’=participants reporting yes for >=1 day or no for all days for specified event for each arm respectively.||percentage of participants|||Number
695199|NCT01392378|Secondary|Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 1|Participants' core (rectal) temperature was collected for 4 days after each vaccination using an electronic diary. Participants' temperature was collected at 6 to 8 hours after vaccination, 6 to 8 hours following that and coincidentally with antipyretic administration for groups receiving antipyretics. Temperature was recorded at bedtime daily for 3 following days (Day 2 to Day 4) and at any time during the 3 days when fever was suspected. The highest temperature for each day was recorded in the e-diary. Incidences of fever were presented in following categories: >=38 but <=39 degree Celsius (degree C), greater than (>) 39 but <=40 degree C and >40 degree C.|Within 4 days after infant series Dose 1|Safety analysis set Dose 1: participants who received Dose 1 of 13vPnC/INFANRIX hexa in infant series, had Adverse Event (AE) or temperature data. ‘N’(number of participants analyzed)=participants reported yes for >=1 day or no for all days, ‘n’=participants reporting yes for >=1 day or no for all days for specified event for each arm respectively.||percentage of participants|||Number
695200|NCT01392378|Secondary|Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose|Percentage of participants achieving pre-specified criteria for concomitant antigens contained in INFANRIX hexa (Hib polyribosylribitol phosphate [PRP] >=0.15 mcg/mL; Hib PRP >=1 mcg/mL; Pertussis PT >=14.8 EU/mL, FHA >=46.5 EU/mL, PRN >=43.5 EU/mL; Tetanus >=0.1 IU/mL; Diphtheria >=0.1 IU/mL; HBV >=10 mIU/mL; Poliomyelitis Type 1, 2, 3 >=1:8 titer) along with the corresponding 95% CIs were presented. Exact 2-sided CI based on the observed proportion of participants. Pre-specified criteria for pertussis was the level that 95% of the participants achieved in 13vPnC + INFANRIX hexa group.|1 month after the toddler dose|mITT toddler immunogenicity population. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies participants with a determinate antibody concentration or titer to the given concomitant vaccine antigen for each arm respectively.||percentage of participants||95% Confidence Interval|Number
695280|NCT01391325|Primary|Safety of Allopurinol|Proportion of subjects who experienced at least one Treatment Emergent Adverse Event (TEAE) during the study.|Every month for 6 months.|All subjects who received at least one dose of allopurinol||percentage of subjects|||Number
695422|NCT01390818|Secondary|Half-Life (t1/2) of MSC1936369B (Pimasertib)||Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts|The PK analysis set. Here “n” signifies the number of subjects evaluable at the specific time points.||hour||Full Range|Median
695201|NCT01392378|Secondary|Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series|Percentage of participants achieving pre-specified criteria for concomitant antigens contained in INFANRIX hexa (Hib polyribosylribitol phosphate [PRP] >=0.15 mcg/mL; Hib PRP >=1 mcg/mL; Pertussis PT >=14.6 EU/mL, FHA >=16.1 EU/mL, PRN >=24.0 EU/mL; Tetanus >=0.1 IU/mL; Diphtheria >=0.1 IU/mL; HBV >=10 mIU/mL; Poliomyelitis Type 1, 2, 3 >=1:8 titer) along with the corresponding 95% CIs were presented. Exact 2-sided CI based on the observed proportion of participants. Pre-specified criteria for pertussis was the level that 95% of the participants achieved in 13vPnC + INFANRIX hexa group.|1 month after the infant series|mITT infant immunogenicity population. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies participants with a determinate antibody concentration or titer to the given concomitant vaccine antigen for each arm respectively.||percentage of participants||95% Confidence Interval|Number
695202|NCT01392378|Secondary|Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Toddler Dose|Geometric LS mean concentration (GMCs) were measured as titers and corresponding 2-sided 95% CIs were evaluated for poliomyelitis type 1, 2 and 3 antibodies.|1 month after the toddler dose|mITT toddler immunogenicity population. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||titer||95% Confidence Interval|Geometric Mean
695203|NCT01392378|Secondary|Geometric Mean Concentration (GMC) for Antigen-specific Hepatitis B Virus (HBV) Antibody 1 Month After the Toddler Dose|Geometric LS mean concentration (GMCs) were measured in mIU/mL and corresponding 2-sided 95% CIs were evaluated for hepatitis B virus (HBV) antibody.|1 month after the toddler dose|mITT toddler immunogenicity population. Here ‘N’ (number of participants analyzed) signifies participants with a determinate antibody concentration to the given concomitant vaccine antigen.||mIU/mL||95% Confidence Interval|Geometric Mean
695204|NCT01392378|Secondary|Geometric Mean Concentration (GMC) for Antigen-specific Tetanus and Diphtheria Antibodies 1 Month After the Toddler Dose|Geometric LS mean concentration (GMCs) were measured in IU/mL and corresponding 2-sided 95% CIs were evaluated for tetanus and diphtheria antibodies.|1 month after the toddler dose|mITT toddler immunogenicity population. Here ‘N’ (number of participants analyzed) signifies participants with a determinate antibody concentration to the given concomitant vaccine antigen.||IU/mL||95% Confidence Interval|Geometric Mean
695205|NCT01392378|Secondary|Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibodies 1 Month After the Toddler Dose|Geometric LS mean concentration (GMCs) were measured in EU/mL and corresponding 2-sided 95% CIs were evaluated for pertussis (pertussis toxin [PT], filamentous hemagglutinin [FHA] and pertactin [PRN]) antibodies.|1 month after the toddler dose|mITT toddler immunogenicity population. Here ‘N’ (number of participants analyzed) signifies participants with a determinate antibody concentration to the given concomitant vaccine antigen.||EU/mL||95% Confidence Interval|Geometric Mean
695206|NCT01392378|Secondary|Geometric Mean Concentration (GMC) for Antigen-specific Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) Antibody 1 Month After the Toddler Dose|Geometric LS mean concentration (GMCs) were measured in mcg/mL and corresponding 2-sided 95% CIs were evaluated for Hib PRP antibody.|1 month after the toddler dose|mITT toddler immunogenicity population. Here ‘N’ (number of participants analyzed) signifies participants with a determinate antibody concentration to the given concomitant vaccine antigen.||mcg/mL||95% Confidence Interval|Geometric Mean
695207|NCT01392378|Secondary|Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Infant Series|Geometric LS mean concentrations (GMCs) were measured as titers and corresponding 2-sided 95% CIs were evaluated for poliomyelitis type 1, 2 and 3 antibodies.|1 month after the infant series|mITT infant immunogenicity population. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||titer||95% Confidence Interval|Geometric Mean
695208|NCT01392378|Secondary|Geometric Mean Concentration (GMC) for Antigen-specific Hepatitis B Virus (HBV) Antibody 1 Month After the Infant Series|Geometric LS mean concentration (GMCs) were measured in milli international units/mL (mIU/mL) and corresponding 2-sided 95% CIs were evaluated for hepatitis B virus (HBV) antibody.|1 month after the infant series|mITT infant immunogenicity population. Here ‘N’ (number of participants analyzed) signifies participants with a determinate antibody concentration to the given concomitant vaccine antigen.||mIU/mL||95% Confidence Interval|Geometric Mean
695209|NCT01392378|Secondary|Geometric Mean Concentration (GMC) for Antigen-specific Tetanus and Diphtheria Antibody 1 Month After the Infant Series|Geometric LS mean concentration (GMCs) were measured in International Units/mL (IU/mL) and corresponding 2-sided 95% CIs were evaluated for tetanus and diphtheria antibodies.|1 month after the infant series|mITT infant immunogenicity population. Here ‘N’ (number of participants analyzed) signifies participants with a determinate antibody concentration to the given concomitant vaccine antigen.||IU/mL||95% Confidence Interval|Geometric Mean
695210|NCT01392378|Secondary|Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibody 1 Month After the Infant Series|Geometric LS mean concentration (GMCs) were measured in Enzyme-linked Immunosorbent Assay (ELISA) units/mL (EU/mL) and corresponding 2-sided 95% CIs were evaluated for pertussis (pertussis toxin [PT], filamentous hemagglutinin [FHA] and pertactin [PRN]) antibodies.|1 month after the infant series|mITT infant immunogenicity population. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||EU/mL||95% Confidence Interval|Geometric Mean
695211|NCT01392378|Secondary|Geometric Mean Concentration (GMC) for Antigen-specific Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) Antibody 1 Month After the Infant Series|Geometric LS mean concentrations (GMCs) and corresponding 2-sided 95% CIs were evaluated for Hib PRP antibody.|1 month after the infant series|mITT infant immunogenicity population. Here ‘N’ (number of participants analyzed) signifies participants with a determinate antibody concentration to the given concomitant vaccine antigen.||mcg/mL||95% Confidence Interval|Geometric Mean
695296|NCT01391273|Primary|Percentage of Participants With at Least a 1-Grade Increase in Overall Eyelash Prominence Using the Global Eyelash Assessment Scale (GEA)|The investigator evaluated the patient's eyelash prominence using the GEA 4-point scale: 1= minimal, 2= moderate, 3= marked and 4= very marked at Baseline and Month 4. At least a 1-grade increase in the GEA score from Baseline indicated improvement.|Baseline, Month 4|Intent to treat population included all randomized participants.||Percentage of participants|||Number
695212|NCT01392378|Secondary|Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series|Antibody-mediated serum OPA against the 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) was measured centrally using a pneumococcal OPA assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs).|1 month after the infant series|mITT infant immunogenicity population. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies participants with a determinate OPA titer to the given serotype for each arm respectively.||titer||95% Confidence Interval|Geometric Mean
695213|NCT01392378|Secondary|Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series|Percentage of participants achieving serotype-specific pneumococcal OPA titer >= LLOQ, along with the corresponding 95% CIs for 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants. The OPA LLOQ in titers for each serotype: 1 = 1:18; 3 = 1:12; 4 = 1:21; 5 = 1:29; 6A = 1:37; 6B = 1:43; 7F = 1:210; 9V = 1:345; 14 = 1:35; 18C = 1:31; 19A = 1:18; 19F = 1:48; 23F = 1:13.|1 month after the infant series|mITT infant immunogenicity population. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies participants with a determinate IgG concentration to the given serotype for each arm respectively.||percentage of participants||95% Confidence Interval|Number
695214|NCT01392378|Secondary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose|Antibody geometric LS mean concentrations (GMCs) for 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies participants with a determinate IgG concentration to the given serotype for each arm respectively.|1 month after the toddler dose|mITT toddler immunogenicity set: eligible participants who had >=1 valid,determinate assay result, 56-98 days of age at Vaccination 1, received antipyretic regimen as per randomization, received all vaccinations, may have had received additional anti-pyretic medication, had blood drawn within specified time frames, had no major protocol violations.||mcg/mL||95% Confidence Interval|Geometric Mean
695215|NCT01392378|Secondary|Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series|Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.|1 month after the infant series|mITT infant immunogenicity population. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.||percentage of participants||95% Confidence Interval|Number
695216|NCT01392378|Primary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series|Antibody geometric least squares (LS) mean concentrations (GMCs) for 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) confidence interval (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.|1 month after the infant series|Modified intent-to-treat (mITT) infant immunogenicity set: all eligible participants who had >=1 valid,determinate assay result, 56-98 days of age at Vaccination 1, received antipyretic regimen as per randomization,may have had received additional anti-pyretic medication,had blood drawn within specified time frames,had no major protocol violations.||microgram per milliliter (mcg/mL)||95% Confidence Interval|Geometric Mean
695217|NCT01392326|Secondary|Percent of Patients With Enthesitis in the Subset of Subjects Who Have Enthesitis at Baseline||Week 24|Full Analysis set||% participants|||Number
695218|NCT01392326|Secondary|Percent of Patients With Dactylitis in the Subset of Subjects Who Have Dactylitis at Baseline||Week 24|Full analysis set||% participants|||Number
695219|NCT01392326|Secondary|Change From Baseline for Joint/Bone Structural Damage (Van Der Heijde Modified Total Sharp Score) for Secukinumab 75 and 150 mg (Pooled Doses)|Measured are 44 joints for erosions: scored 0 to 5 in hands; 0 to 10 in feet;40 joints for joint space narrowing; summed for total score by two experienced readers scored every film blinded to patient identity, treatment, sequence of film. Lower score equals better outcome. With score of zero being normal. Joint structural damage change from baseline at Week 24 using non-parametric ANCOVA, Linear extrapolation. Estimate (for the difference in mean), SE are from a non-parametric ANCOVA model with the change from baseline van der Heijde total modified Sharp score as the dependent variable, treatment and randomization stratum (TNFa status -naive or IR ) as factors, and weight and baseline van der Heijde total modified Sharp score as covariates.|Week 24|.Full analysis set.||units on a scale||Standard Error|Mean
695220|NCT01392326|Secondary|Percent of Patients Achieving ACR50 Response Criteria on Secukinumab 75 or 150 mg vs. Placebo|ACR50 = 50 % improvement in at least 3 of the 5 measures( Patient's assessment of pain, Patient's global assessment of disease activity, Physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score, C-reactive protein (CRP)/Erythrocyte Sedimentation Rate (ESR) and 50 % improvement in the swollen and tender joint count.|Week 24|Full analysis set||% participant|||Number
695281|NCT01391312|Secondary|Percentage of Facial Wrinkle Scale Responders at Maximum Attempted Muscle Contraction at Day 60|The Investigator rated the subject’s severity of glabellar lines (between the eyebrows) at maximum attempted muscle contraction using the 4-point Facial Wrinkle scale where 0=None (Best), 1=Mild, 2=Moderate, 3=Severe (Worse) at day 60. Responders were defined as participants with a score of 0=None or 1=Mild.|Day 60|Participants from the Intent-to-treat population (all randomized participants) with data available for the time-point.||Percentage of participants|||Number
695221|NCT01392326|Secondary|Change From Baseline in HAQ-DI for Secukinumab 75 or 150 mg|"HAQ-DI, assesses a patient's level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities. There are 20 questions in eight categories of functioning which represent a comprehensive set of functional activities – dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. The stem of each item asks over the past week Are you able to … perform a particular task. The patient's responses are made on a scale from zero (no disability) to three (completely disabled)."|Week 24|Full Analysis Set||units on a scale||Standard Error|Least Squares Mean
695222|NCT01392326|Secondary|Change From Baseline in SF36-PCS for Secukinumab 75 or 150 mg|The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.|Week 24|Full Analysis Set||units on scale||Standard Error|Least Squares Mean
695223|NCT01392326|Secondary|Change From Baseline in DAS28-CRP for Secukinumab 75 or 150 mg|"DAS-CRP values range from 2.0 to 10.0 while higher values mean a higher disease activity. A DAS-CRP below the value of 2.6 is interpreted as Remission.DAS28 the DAS-CRP uses 28 different joints for its calculation: proximal interphalangeal joints (10 joints) metacarpophalangeal joints (10) wrists (2) elbows (2) shoulders (2) knees (2) With the above mentioned parameters, DAS-CRP is calculated as: <math>DAS-CRP=0.56 \times \sqrt{TEN28} + 0.28 \times \sqrt{SW28} + 0.36 \times \ln(CRP+1) + 0.014 \times SA+0.96</math> With: TEN28: number of joints with tenderness upon touching SW28: number of swollen joints CRP: C-reactive Protein SA: subjective assessment of disease activity by the patient during the preceding 7 days on a scale betweenn 0 and 100 (0:no activity, 100: highest activity possible)"|Week 24|Full Analysis Set||units on scale||Standard Error|Least Squares Mean
695224|NCT01392326|Secondary|Percent of Subjects Achieving a PASI90 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis at Baseline|A 90% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 90) is above the current benchmark of primary endpoints for most clinical trials with endpoints of psoriasis|Week 24|Full Analysis Set||% of participants acheiving goal|||Number
695225|NCT01392326|Secondary|Percent of Subjects Achieving a PASI75 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis at Baseline|A 75% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 75) is the current benchmark of primary endpoints for most clinical trials with end points of psoriasis|Week 24|Full Analysis Set||% participants acheiving goal|||Number
695226|NCT01392326|Primary|Percent of Patients Achieving ACR20 Response Criteria on Secukinumab 75 or 150 mg vs. Placebo|A patient will be considered as improved according the ACR20 criteria if she/he has at least 20 % improvement in the two following measures:Tender joint count,Swollen joint count and at least 3 of the following 5 measures: Patient's assessment of pain, Patient's global assessment disease activity,Physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score,Acute phase reactant (hsCRP or ESR)|Week 24|Full analysis set||% participant|||Number
695227|NCT01392300|Secondary|Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Pain|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Week 12|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.||units on a scale||Standard Error|Least Squares Mean
695228|NCT01392300|Secondary|Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Pain|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Week 8|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.||units on a scale||Standard Error|Least Squares Mean
695229|NCT01392300|Secondary|Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Pain|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.||units on a scale||Standard Error|Least Squares Mean
695230|NCT01392300|Secondary|Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Limb Position|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Week 12|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.||units on a scale||Standard Error|Least Squares Mean
695231|NCT01392300|Secondary|Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Limb Position|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Week 8|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.||units on a scale||Standard Error|Least Squares Mean
695232|NCT01392300|Secondary|Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Limb Position|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.||units on a scale||Standard Error|Least Squares Mean
695233|NCT01392300|Secondary|Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Dressing|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Week 12|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.||units on a scale||Standard Error|Least Squares Mean
695234|NCT01392300|Secondary|Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Dressing|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Week 8|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.||units on a scale||Standard Error|Least Squares Mean
695235|NCT01392300|Secondary|Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Dressing|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.||units on a scale||Standard Error|Least Squares Mean
695236|NCT01392300|Secondary|Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Hygiene|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Week 12|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.||units on a scale||Standard Error|Least Squares Mean
695237|NCT01392300|Secondary|Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Hygiene|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Week 8|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.||units on a scale||Standard Error|Least Squares Mean
695238|NCT01392300|Secondary|Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Hygiene|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.||units on a scale||Standard Error|Least Squares Mean
695239|NCT01392300|Secondary|Changes From Baseline to Week 12 in Disability Assessment Scale - Principal Therapeutic Target Domain|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Week 12|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.||units on a scale||Standard Error|Least Squares Mean
695240|NCT01392300|Secondary|Changes From Baseline to Week 8 in Disability Assessment Scale - Principal Therapeutic Target Domain|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Week 8|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.||units on a scale||Standard Error|Least Squares Mean
695241|NCT01392300|Secondary|Changes From Baseline to Week 4 in Disability Assessment Scale - Principal Therapeutic Target Domain|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.||units on a scale||Standard Error|Least Squares Mean
695242|NCT01392300|Secondary|Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Pronated Forearm.|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|Week 12|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.||units on a scale||Standard Error|Least Squares Mean
695243|NCT01392300|Secondary|Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Pronated Forearm.|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|Week 8|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.||units on a scale||Standard Error|Least Squares Mean
695244|NCT01392300|Secondary|Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Pronated Forearm.|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.||units on a scale||Standard Error|Least Squares Mean
695245|NCT01392300|Secondary|Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Thumb-in-palm.|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|Week 12|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.||units on a scale||Standard Error|Least Squares Mean
695246|NCT01392300|Secondary|Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Thumb-in-palm.|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|Week 8|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.||units on a scale||Standard Error|Least Squares Mean
695247|NCT01392300|Secondary|Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Thumb-in-palm.|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.||units on a scale||Standard Error|Least Squares Mean
695248|NCT01392300|Secondary|Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Clenched Fist.|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|Week 12|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.||units on a scale||Standard Error|Least Squares Mean
695249|NCT01392300|Secondary|Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Clenched Fist.|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|Week 8|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.||units on a scale||Standard Error|Least Squares Mean
695250|NCT01392300|Secondary|Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Clenched Fist.|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.||units on a scale||Standard Error|Least Squares Mean
695295|NCT01391273|Secondary|Change From Baseline in Eyelash Length as Measured by Digital Image Analysis (DIA)|Photographs were taken of the eyelashes and assessed using DIA. Length was measured in millimeters (mm). Data from both eyes were averaged for each participant for analysis. A positive change from Baseline indicated longer length (improvement).|Baseline, Month 4|Intent to treat population included all randomized participants.||mm||Standard Deviation|Mean
695251|NCT01392300|Secondary|Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Flexed Elbow.|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|Week 12|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.||units on a scale||Standard Error|Least Squares Mean
695252|NCT01392300|Secondary|Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Flexed Elbow.|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|Week 8|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.||units on a scale||Standard Error|Least Squares Mean
695253|NCT01392300|Secondary|Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Flexed Elbow.|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.||units on a scale||Standard Error|Least Squares Mean
695254|NCT01392300|Secondary|Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Flexed Wrist.|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|Week 12|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.||units on a scale||Standard Error|Least Squares Mean
695255|NCT01392300|Secondary|Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Flexed Wrist.|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|Week 8|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.||units on a scale||Standard Error|Least Squares Mean
695256|NCT01392300|Secondary|Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Flexed Wrist.|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.||units on a scale||Standard Error|Least Squares Mean
695257|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Pronated Forearm|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 12|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).||participants|||Number
695258|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Pronated Forearm|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 8|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).||participants|||Number
695259|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Pronated Forearm|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).||participants|||Number
695352|NCT01391468|Post-Hoc|Change of Serum Endotoxin Level at 6 Months|endotoxin is a marker of inflammation in chronic kidney disease patients|6 months follow-up|||EU/ml||Standard Deviation|Mean
701093|NCT00058825|Secondary|Time in Days to ANC Engraftment|Engraftment was defined as the day of absolute neutrophil counts (ANC) exceeded 0.5 X 10^9/L on the first of 3 days.|30 days|||days||Full Range|Median
695260|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Thumb-in-palm|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 12|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).||participants|||Number
695261|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Thumb-in-palm|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 8|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).||participants|||Number
695262|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Thumb-in-palm|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).||participants|||Number
695263|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Clenched Fist|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 12|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).||participants|||Number
695264|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Clenched Fist|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 8|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).||participants|||Number
695265|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Clenched Fist|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).||participants|||Number
695266|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Flexed Elbow|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 12|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).||participants|||Number
695267|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Flexed Elbow|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 8|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).||participants|||Number
695268|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Flexed Elbow|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).||participants|||Number
701094|NCT00058825|Primary|Transplant Related Mortality (TRM)|Percentage of patients with transplant related mortality|100 days|||percentage of participants||97.5% Confidence Interval|Number
695269|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Flexed Wrist|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 12|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).||participants|||Number
695270|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Flexed Wrist|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 8|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).||participants|||Number
695271|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Flexed Wrist|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).||participants|||Number
695272|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 12 Calculated for the Primary Target Clinical Pattern|Primary target clinical pattern was defined by investigator for each subject at baseline visit and was either flexed wrist or clenched fist or flexed elbow. Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 12|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).||participants|||Number
695273|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 8 Calculated for the Primary Target Clinical Pattern|Primary target clinical pattern was defined by investigator for each subject at baseline visit and was either flexed wrist or clenched fist or flexed elbow. Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 8|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).||participants|||Number
695274|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 4 Calculated for the Primary Target Clinical Pattern|Primary target clinical pattern was defined by investigator for each subject at baseline visit and was either flexed wrist or clenched fist or flexed elbow. Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).||participants|||Number
695275|NCT01392300|Primary|Investigator's Global Impression of Change|This is the co-primary outcome measure. The Global Impression of Change Scale [GICS] is used to measure the investigator's impression of change due to treatment. The response option is a common 7-point Likert scale that ranges from -3 = very much worse to +3 = very much improved.|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by zero change (worst case).||units on a scale||Standard Error|Least Squares Mean
695276|NCT01392300|Primary|Change From Baseline in Ashworth Scale (AS) Score of Primary Target Clinical Pattern|"Primary target clinical pattern was defined by investigator for each subject at baseline visit and was either flexed wrist or clenched fist or flexed elbow.
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension)."|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.||units on a scale||Standard Error|Least Squares Mean
695277|NCT01391325|Secondary|Mean Change From Baseline to Month 6 in SF-36 PCS+MCS|The SF-36 is a short-form health survey with 36 questions that yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical (PCS) and mental health (MCS) summary. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability. The higher the score the less disability. The component scores (PCS and MCS) are norm-based to a standard population with a mean of 50 and a standard deviation of 10.|Month 6|Subjects who recieved at least one dose of allopurinol||units on a scale||Standard Deviation|Mean
695278|NCT01391325|Secondary|Incidence of Gout Flares|Proportion of subjects who experienced at least one gout flare requiring treatment during the study.|Every month for 6 months.|Subjects who received at least one dose of allopurinol||percentage of subjects||95% Confidence Interval|Number
695279|NCT01391325|Secondary|Proportion of Subjects With Serum Urate (sUA) Less Than 6.0 mg/dL|Proportion of subjects with serum urate (sUA) less than 6.0 mg/dL at Month 6 using Last Observation Carried Forward (LOCF) for subjects with missing values at Month 6.|Month 6|All subjects who received at least one dose of allopurinol||percentage of subjects||95% Confidence Interval|Number
695282|NCT01391312|Secondary|Percentage of Facial Wrinkle Scale Responders at Maximum Attempted Muscle Contraction at Day 30|The Investigator rated the subject’s severity of glabellar lines (between the eyebrows) at maximum attempted muscle contraction using the 4-point Facial Wrinkle scale where 0=None (Best), 1=Mild, 2=Moderate, 3=Severe (Worse) at day 30. Responders were defined as participants with a score of 0=None or 1=Mild.|Day 30|Participants from the Intent-to-treat population (all randomized participants) with data available for the time-point.||Percentage of participants|||Number
695283|NCT01391312|Primary|Percentage of Participants With Improvement in Subject Global Assessment of Change at Day 30|Subjects assessed the improvement of their glabellar lines (area between the eyebrows) by answering the question: Compared to before receiving the study treatment, How do you currently feel about the appearance of your glabellar lines? on a 7-point scale where 0=Very much improved, 1=Much improved, 2=Minimally improved, 3=No change, 4=Minimally worse, 5=Much worse, 6=Very much worse. Improvement was defined as responses: 0=Very much improved, 1=Much improved and 2=Minimally improved.|Day 30|Participants from the Intent-to-treat population (all randomized participants) with data available for the time-point.||Percentage of participants|||Number
695284|NCT01391299|Secondary|Percentage of Participants With a ≥1 Grade Improvement From Baseline by Subject-Assessed FWS in Forehead Lines at Rest|Participants assessed the severity of their forehead lines at rest using the 4-point FWS: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a ≥1 grade improvement from baseline.|Baseline, Day 30|Participants from the intent-to-treat population (all randomized participants) with a Facial Wrinkle Score of at least mild at baseline.||Percentage of participants|||Number
695285|NCT01391299|Secondary|Percentage of Participants With a ≥1 Grade Improvement From Baseline by Investigator-Assessed FWS in Forehead Lines at Rest|The Investigator assessed the severity of the patient's forehead lines at rest using the 4-point FWS: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a ≥1 grade improvement from baseline.|Baseline, Day 30|Participants from the intent-to-treat population (all randomized participants) with a Facial Wrinkle Score of at least mild at baseline.||Percentage of participants|||Number
695286|NCT01391299|Secondary|Percentage of Participants Achieving Satisfied or Very Satisfied by Subject Assessment of Satisfaction of Appearance of Forehead Lines|Participants rated their overall satisfaction with the appearance of the forehead line area using a 5-point scale: 1=very unsatisfied, 2=unsatisfied, 3=neutral, 4=satisfied or 5=very satisfied. The percentage of participants with a rating of satisfied or very satisfied at Day 30.|Day 30|Includes participants from the Intent-to-treat Population (all randomized participants) with a rating of very unsatisfied, unsatisfied or neutral in the Subject's Assessment of Satisfaction of Appearance at baseline.||Percentage of participants|||Number
695287|NCT01391299|Primary|Percentage of Participants Achieving a Score of None or Mild by Subject-Assessed Facial Wrinkle Scale With Photonumeric Guide (FWS) in Forehead Lines at Maximum Eyebrow Elevation|The patient assessed the severity of their forehead lines at maximum eyebrow elevation using the 4-point FWS: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30.|Day 30|Intent-to-treat population included all randomized participants.||Percentage of participants|||Number
695288|NCT01391299|Primary|Percentage of Participants Achieving a Score of None or Mild by Investigator-Assessed Facial Wrinkle Scale With Photonumeric Guide (FWS) in Forehead Lines at Maximum Eyebrow Elevation|The Investigator assessed the severity of the patient's forehead lines at maximum eyebrow elevation using the 4-point FWS: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30.|Day 30|Intent-to-treat population included all randomized participants.||Percentage of participants|||Number
695289|NCT01391286|Secondary|Change From Baseline in Eyelash Darkness as Measured by DIA|Photographs were taken of the eyelashes and assessed using DIA. Eyelash darkness was measured in both eyes and averaged for analysis using a scale where 0=black and 255=white. A negative change from Baseline indicated darker eyelashes (improvement).|Baseline, Month 4|Participants from the Intent to treat population with data available for analysis.||Units on a scale||Full Range|Median
695290|NCT01391286|Secondary|Change From Baseline in Eyelash Thickness as Measured by DIA|Photographs were taken of the eyelashes and assessed using DIA. Eyelash thickness (fullness) was assessed across both eyes as an average and is measured in millimeters squared (mm^2). A positive change from Baseline indicated fuller eyelashes (improvement).|Baseline, Month 4|Participants from the Intent to treat population with data available for analysis.||mm^2||Full Range|Median
695291|NCT01391286|Secondary|Change From Baseline in Eyelash Length as Measured by Digital Image Analysis (DIA)|Photographs were taken of the eyelashes and assessed using DIA. Length was measured in millimeters (mm). Data from both eyes were averaged for each participant for analysis. A positive change from Baseline indicated longer length (improvement).|Baseline, Month 4|Participants from the Intent to treat population with data available for analysis.||mm||Full Range|Median
695292|NCT01391286|Primary|Percentage of Participants With at Least a 1-Grade Increase in Overall Eyelash Prominence Using the Global Eyelash Assessment Scale (GEA)|The investigator evaluated the patient's eyelash prominence using the GEA 4-point scale: 1= minimal, 2= moderate, 3= marked and 4= very marked at Baseline and Month 4. At least a 1-grade increase in the GEA score from Baseline indicated improvement.|Baseline, Month 4|Intent to treat population included all randomized participants.||Percentage of participants|||Number
695293|NCT01391273|Secondary|Change From Baseline in Eyelash Darkness as Measured by DIA|Photographs were taken of the eyelashes and assessed using DIA. Eyelash darkness was measured in both eyes and averaged for analysis using a scale where 0=black and 255=white. A negative change from Baseline indicated darker eyelashes (improvement).|Baseline, Month 4|Participants from the Intent to treat population with data available for analysis.||Units on a scale||Standard Deviation|Mean
695294|NCT01391273|Secondary|Change From Baseline in Eyelash Thickness as Measured by DIA|Photographs were taken of the eyelashes and assessed using DIA. Eyelash thickness (fullness) was assessed across both eyes as an average and is measured in millimeters squared (mm^2). A positive change from Baseline indicated fuller eyelashes (improvement).|Baseline, Month 4|Participants from the Intent to treat population with data available for analysis.||mm^2||Standard Deviation|Mean
695353|NCT01391468|Secondary|Change of Gastrointestinal Symptoms at 6 Months|The change in gastrointestinal symptom rating scale (min and maximum scores 0-45) after treatment. The total score is reported. The higher scale represents a worse outcome.|6 months follow-up|||units on a scale||Standard Deviation|Mean
695297|NCT01392170|Primary|Number of Participants Achieved of Major Molecular Response (MMR) or Complete Molecular Response (CMR)|Molecular response defined as: major molecular response (MMR) corresponds to a BCR-ABL1/ABL1 ratio of <=0.01. Complete molecular response (CMR) is defined as undetectable BCR-ABL1 transcripts. Molecular response measured every 3 months (a total of 4 assessments within one year of therapy).|12 months from start of treatment with PEG-IFNá-2a|Study terminated due to low accrual. No participants were evaluable for outcome.|||||
695298|NCT01392053|Secondary|Satisfaction of Mothers With the Presence of a Professional by Their Side During the Study Period.|Considering the first labour to be a unique experience to every women, and also a moment of many doubts and insecurities, it is considered that the presence of a healthcare professional, providing information and support, during this moment, could be benefitial to most first time mothers. Therefore, the presence of a physiotherapist could have helped minimize the suffering in both groups. The questionnaire applied after labour intended to assess how most women felt regarding this subject.|30 minutes|All patients participatin in the study answered a satisfaction questionnaire after labour.||participants|||Number
695299|NCT01392053|Secondary|Obstetric Outcomes - Moment of Utilization of Oxytocin|Oxytocin is a drug used to induce or enhance the muscular activity of the uterus. In this study, the moment when this event happened was associated to the dilation of the uterus cervyx, considering this to be a more reliable data rather than the timelapse of labor. This outcome is measured in centimeter when the women is assessed by the doctor.|10 hours|All patients in both groups were analyzed||centimeters||Standard Deviation|Mean
695300|NCT01392053|Secondary|Obstetric Outcome - Moment of Corioamniorrhexis|Corioamniorrhexis may occur during the normal evolution of labour or due to medical conditions. In this study, the moment when this event happened was associated to the dilation of the uterus cervyx, considering this to be a more reliable datum rather than the timelapse of labor. This outcome is measured in centimeter when the women is assessed by the doctor.|10 hours|All patients in both groups were analyzed||centimeters||Standard Deviation|Mean
695301|NCT01392053|Secondary|Obstetric Outcomes - Duration of Labour|"The time elapsed between hospital admission and delivery was measured to compare the influence of the procedures established in the study design. It was defined two sets of measures dichotomizing the groups into up to 7 hours or more than 7 hours."|10 hours|All patients in both groups were analyzed||percentage of participants|||Number
695302|NCT01392053|Secondary|Obstetric Outcomes - Delivery|Labour can either occur via vaginal canal, also called natural birth, or via caesarian section, which is a surgical procedure used when either the mother or the baby are in distress.|10 hours|All patients of both groups were analyzed.||participants|||Number
695303|NCT01392053|Secondary|Pharmacological Analgesia Request According to the Cervical Dilation.|In the institution where this study was conducted, the request for analgesia, made by the patient, is granted promptly. Considering that the further the cervyx dilation grows, the greater the pain intensity is, the cervical dilation was used as an indicator of the moment that the women in labour requested this procedure, and, therefore, could provide a comparison between methods.|10 hours|Of the 46 patients who where evaluated, only 1 (one) in each group didn't request pharmacological analgesia and, thus, were excluded of the analysis of this specific outcome||centimeters||Standard Deviation|Mean
695304|NCT01392053|Primary|Effectiveness of Massage Therapy in Pain Relief During Labor.|The Visual Analogue Scale was used to assess the pain intensitiy after each procedure according to the study design. The VAS is a scale composed by a straight line printed on a paper measuring 100 milimeters, where only the 0 (Zero) and the 100 (one hundred) points are marked. The patient is then asked to mark this line accordingly to the intensity of the pain felt in that moment, considering 0 (Zero) to be no pain at all, and 100 (one hundred) to be the most unbearable pain ever suffered. The researcher would measure the distance, in milimeters, from the 0 (Zero)mm to the point were the patient marked, wich was considered to be the intensity of the pain felt by the patient in that moment. A reduction of 13mm or more in this scale is considered to be a significative pain reduction.|30 minutes|A pilot study was conducted previously to determine the size of the population needed. Using a paired sample t-test, with a power of 95% and 5% significance level, it was determined a minimum of 12 patients for Control Group and 16 patients for Massage Group||milimeters||Standard Deviation|Mean
695305|NCT01391858|Secondary|Pain Scores|Visual Analog Pain Scores (VAS); 0 (no pain) to 10 (worst possible pain)|Participants` pain score was assessed after discharge on the 90th day after mastectomy|||units on a scale||Inter-Quartile Range|Median
695306|NCT01391858|Secondary|Pain Scores|Visual Analog Pain Scores (VAS); 0 (no pain) to 10 (worst possible pain)|Participants` pain score was assessed after discharge on the 30th day after mastectomy|||units on a scale||Inter-Quartile Range|Median
695307|NCT01391858|Secondary|Pain Scores|Visual Analog Pain Scores (VAS); 0 (no pain) to 10 (worst possible pain)|Participants` pain score was assessed after discharge on the 14th day after mastectomy|||units on a scale||Inter-Quartile Range|Median
695308|NCT01391858|Secondary|Pain Scores|Visual Analog Pain Scores (VAS); 0 (no pain) to 10 (worst possible pain)|Participants` pain score was assessed after discharge on the 7th day after mastectomy|||units on a scale||Inter-Quartile Range|Median
695309|NCT01391858|Secondary|Pain Scores|Visual Analog Pain Scores (VAS); 0 (no pain) to 10 (worst possible pain)|Participants` pain score was assessed at hospital discharge, an average of 3 days after mastectomy|||units on a scale||Inter-Quartile Range|Median
695310|NCT01391858|Secondary|Pain Scores|Visual Analog Pain Scores (VAS); 0 (no pain) to 10 (worst possible pain)|Participants` pain score was assessed on the first postoperative day after mastectomy|||units on a scale||Inter-Quartile Range|Median
695311|NCT01391858|Primary|Oral Opioids Consumption|Oral opioids consumption after mastectomy until hospital discharge.|Participants were followed for the consumption of oral opioid for the duration of hospital stay, an average of 3 days after mastectomy|||milligram (mg)||Inter-Quartile Range|Median
695312|NCT01391858|Primary|The Postoperative Opioid Requirement After Mastectomy|IV Patient Controlled Analgesia (PCA) morphine for rescue pain management in the immediate postoperative period for an average of 24 hrs after mastectomy|Participants received PCA pump, an average of 24 hrs after mastectomy|||milligram (mg)||Inter-Quartile Range|Median
695354|NCT01391468|Primary|the Occurrence of Cardiovascular Event and Peritonitis Events||6 month follow-up|||participants|||Number
695454|NCT01390415|Primary|Number of Participants With Macroalbuminuria After 6 Months of Treatment|Macroalbuminuria was defined as having an albumin/creatinine ratio (ACR) >300 mg/g and ≥30% increase from baseline.|Baseline and Month 6|||participants|||Number
695313|NCT01391819|Secondary|Number of Dengue Episodes Associated With Clinical Symptoms|Dengue related clinical symptoms included general symptoms, digestive symptoms, respiratory symptoms, hemorrhagic symptoms and any other signs among first symptoms.|From Day 0 to Year 3|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.||Dengue episodes|||Number
695314|NCT01391819|Secondary|Number of Dengue Episodes With Any Temperature Interval|Temperature intervals assessed varied from hipotermia 33.5 to 36.4 degrees celsius (°C), to normal temperature 36.5-35.9 °C and hipertermia 37 - 39.9 °C, or were unknown.|From Day 0 to Year 3|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.||Dengue episodes|||Number
695315|NCT01391819|Secondary|Dengue Infection Episodes Related Temperature|Temperature, expressed in degrees Celsius (°C), was among symptoms of symptomatic dengue infection.|From Day 0 to Year 3|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.||°C||Standard Deviation|Mean
695316|NCT01391819|Secondary|Number of Hospitalization Days Due to Suspected Dengue Cases|Length of hospitalization was part of the direct medical resource, associated with dengue infection.|From Day 0 to Year 3|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.||Days||Standard Deviation|Mean
695317|NCT01391819|Secondary|Direct Medical Resource Associated With Suspected Dengue Cases|Direct medical resource included hospitalization, stay in intensive care units (ICU), medications, diagnostic and therapeutic procedures|From Day 0 to Year 3|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.||Suspected dengue infection|||Number
695318|NCT01391819|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Day 0 to Year 3|The analysis was performed on the Total cohort, which included all subjects enrolled in the study||Subjects|||Number
695319|NCT01391819|Secondary|Subjects Absenteeism Associated With Dengue Illness|The number of suspected dengue infections with subjects missing from school due to dengue infection were recorded as part of the dengue active surveillance.|Up to Day 35 post laboratory confirmed dengue onset|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.||Suspected dengue infection|||Number
695320|NCT01391819|Secondary|Number of School Days Missed by Subjects|The number of school days missed by subjects due to dengue infection were recorded as part of the dengue active surveillance.|Up to Day 35 post laboratory confirmed dengue onset|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.||Days||Standard Deviation|Mean
695321|NCT01391819|Secondary|Caregiver Absenteeism Associated With Subject Dengue Illness|The number of suspected dengue infections with primary caregivers missing from work was recorded as part of health economics indirect resource utilization.|Up to Day 35 post laboratory confirmed dengue onset|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.||Suspected dengue infection|||Number
695322|NCT01391819|Secondary|Number of Working Days Missed of Primary Care Giver 1 and 2|The number of days off work from caregiver were recorded as part of health economics indirect resource utilization.|Up to Day 35 post laboratory confirmed dengue onset|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.||Days||Standard Deviation|Mean
695323|NCT01391819|Secondary|Number of Secondary Laboratory Confirmed Symptomatic Dengue Infection Cases|Secondary symptomatic dengue infection cases are defined as laboratory confirmed symptomatic dengue cases whose previous sample collected at scheduled visits to detect anti-dengue IgG antibodies were seronegative or seropositive, respectively.|From Day 0 to Year 3|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.||Subjects|||Number
695324|NCT01391819|Secondary|Number of Primary Laboratory Confirmed Symptomatic Dengue Infection Cases|Primary symptomatic dengue infection cases are defined as laboratory confirmed symptomatic dengue cases whose previous sample collected at scheduled visits to detect anti-dengue IgG antibodies were seronegative or seropositive, respectively. Analysis was done by calendar year and age strata.|From Day 0 to Year 3|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.||Subjects|||Number
695325|NCT01391819|Secondary|Number of Dengue Infection Cases by Virus Type|Among virus types causing dengue infection were DENV-4 in 2012 and 2013 and DENV-1 in 214, as assessed by PCR.|From Day 0 to Year 3|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.||Subjects|||Number
695355|NCT01391013|Secondary|Change From Baseline in Cluster of Differentiation 4 (CD4) Count Over Week 48||Screening (Week -4), Week 1 (Day 1), Week 4, Week 12, Week 24, Week 36, Week 48, and follow-up (Week 52)|Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.||CD4 cells||Inter-Quartile Range|Median
695326|NCT01391819|Secondary|Number of Subjects With Laboratory Confirmed and Probable Dengue Cases|"A case of primary or secondary symptomatic dengue infection was defined as laboratory confirmed or probable symptomatic dengue case whose previous sample collected at scheduled Visits 1- 4 (Day 0- Year 3) to detect anti-dengue IgG antibodies was seronegative or seropositive, respectively.
A probable dengue case was defined as a suspected symptomatic dengue case with the following laboratory findings: -anti-dengue IgM or anti-dengue IgG positivity in at least one sample (in either blood sample 1 or 2); no evidence of viremia (negative dengue virus identification through RT-qPCR) in blood sample 1; and no evidence of anti-dengue Ig M or IgG seroconversion between blood sample 1 and blood sample 2."|From Year 0 to Year 3|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.||Subjects|||Number
695327|NCT01391819|Secondary|Number of Subjects With Asymptomatic Dengue Primary Infection|Asymptomatic dengue primary infection was defined as a documented seroconversion (anti-dengue IgG antibodies) between two sequential sera samples obtained during the scheduled visits, without suspicion of dengue.|From Day 0 to Year 3|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.||Subjects|||Number
695328|NCT01391819|Secondary|Number of Subjects With Immunoglobulin Type G (IgG) Antibodies Against Dengue|Immune response against dengue was assessed via the Enzyme-linked Immunosorbent Assay (ELISA)|From Day 0 to Year 3|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.||Subjects|||Number
695329|NCT01391819|Primary|Number of Laboratory Confirmed Symptomatic Dengue Cases|Laboratory-confirmed dengue infection refers to suspected symptomatic dengue cases with positive dengue virus identification or serologic evidence of dengue infection through Reverse Transcriptase quantitative Polymerase Chain Reaction (RT-qPCR) from first blood sample or anti-dengue Immunoglobulin type M/G (IgM/G) seroconversions between first and second blood sampling.|At Year 3 (2014)|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.||Cases|||Number
695330|NCT01391819|Primary|Number of Laboratory Confirmed Symptomatic Dengue Virus Cases|Laboratory-confirmed dengue infection refers to suspected symptomatic dengue cases with positive dengue virus identification or serologic evidence of dengue infection through Reverse Transcriptase quantitative Polymerase Chain Reaction (RT-qPCR) from first blood sample or anti-dengue Immunoglobulin type M/G (IgM/G) seroconversions between first and second blood sampling.|At Year 2 (2013)|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.||Cases|||Number
695331|NCT01391819|Primary|Number of Laboratory Confirmed Symptomatic Dengue Infection Cases|Laboratory-confirmed dengue infection refers to suspected symptomatic dengue cases with positive dengue virus identification or serologic evidence of dengue infection through Reverse Transcriptase quantitative Polymerase Chain Reaction (RT-qPCR) from first blood sample or anti-dengue Immunoglobulin type M/G (IgM/G) seroconversions between first and second blood sampling.|At Year 1 (2012)|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.||Cases|||Number
695332|NCT01391663|Primary|Oral Clearance (CL/F) Pharmacokinetic Parameter|CL/F is apparent clearance of the drug from the plasma after administration of a single dose of the study drug.|Day 1-4|Healthy Korean Participants||L/hr||Standard Deviation|Mean
695333|NCT01391663|Primary|Terminal Phase Elimination Half-life (T1/2) Pharmacokinetic Parameter|Time required for half of the drug to be eliminated from the plasma after administration of a single dose of the study drug.|Day 1-4|Healthy Korean Participants||hr||Standard Deviation|Mean
695334|NCT01391663|Primary|AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Pharmacokinetic Parameter.|Area under the curve from 0 to 24 hours after administrations of a single dose and multiple doses of the study drug.|Day 1-4, Day 10.|Healthy Korean Participants||ng·hr/mL||Standard Deviation|Mean
695335|NCT01391663|Primary|AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Pharmacokinetic Parameter|Area under the plasma concentration-time curve from time 0 to infinity after administration of a single dose of the study drug.|Day 1-4|Healthy Korean Participants||ng·hr/mL||Standard Deviation|Mean
695336|NCT01391663|Primary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) Pharmacokinetic Parameter|Time to reach the maximum plasma concentration (Tmax) after administrations of a single dose and multiple doses of the study drug|Day 1-4, Day 10.|Healthy Korean Participants||hr||Full Range|Median
695337|NCT01391663|Primary|Cmax: Maximum Observed Plasma Concentration Pharmacokinetic Parameter|Maximum observed plasma concentration (Cmax) is the peak plasma concentration after administrations of a single dose and multiple doses of the study drug|Day 1-4, Day 10|Healthy Korean Participants||ng/mL||Standard Deviation|Mean
695338|NCT01391611|Secondary|Response Per Choi Criteria|"Response per Choi criteria
Complete response - Disappearance of all lesions; no new lesion
Partial response - A decrease in size of > or = 10% or a decrease in tumor density (HU) > or = 15% on CT. No new lesions. No obvious progression of nonmeasurable disease.
Stable disease - Does not meet the criteria for CR, PR, or PD. No symptomatic deterioration attributed to tumor progression.
Progressive disease - An increase in tumor size of > or = 10% and does not meet criteria of PR by tumor density (HU) on CT. New lesions. New intratumoral nodules or increase in the size of the existing intratumoral nodules."|6 months|Choi criteria measurements were not done due to technical difficulties.|||||
695370|NCT01391013|Secondary|Change From Baseline to Week 48 in Brachial Artery FMD: Median Change in FMD (%)|Brachial artery FMD is calculated as the percentage increase in brachial artery diameter with hyperemia induced relative to the resting brachial artery diameter. Percentage of brachial artery diameter is measured as FMD diameter/basal diameter.|Baseline to Week 48|Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.||Percentage of brachial artery diameter||Inter-Quartile Range|Median
695339|NCT01391611|Primary|Non-progression Rate Based on RECIST 1.0 Criteria (CR+PR+SD)|"4-mo non-progression rate
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression"|24 weeks|||months||95% Confidence Interval|Median
695340|NCT01391559|Primary|Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline at Two Hours After Inhalation of the Study Medication|FEV1|2 hours|||mL||Standard Deviation|Mean
695341|NCT01391507|Secondary|Number of Participants With Holter Electrocardiography (ECG) Parameters|A Holter monitor is a portable device which monitors the electrical activity (electrocardiography) of the heart. Block, Heart rhythm, AV junctional, Ventricular, Lown classification, Results were evaluated.|Baseline and Month 6|Safety population included all participants who received at least 1 dose of the study agent.||Participants|||Number
695342|NCT01391507|Secondary|Change From Baseline in Holter Electrocardiography (ECG) Parameters (Heart Rate) at Month 6|A Holter monitor is a portable device which monitors the electrical activity (electrocardiography) of the heart. Mean heart rate, maximum heart rate and minimum heart rate were evaluated.|Baseline and Month 6|Safety population included all participants who received at least 1 dose of the study agent.||Beats per minute||Standard Deviation|Mean
695343|NCT01391507|Secondary|Change From Baseline in Minnesota Living With Heart Failure Questionnaire Score at Month 6|Minnesota living with heart failure questionnaire is a self-administered, disease-specific measure of health related quality of life (QOL) that assesses participant’s perceptions of the influence of heart failure on physical, socioeconomic and psychological aspects of life. Participants responded to 21 items using a six-point response scale (0-5). The total summary score can range from 0-105 with a lower score reflecting better heart failure related QOL.|Baseline and Month 6|ITT population included all participants who were randomly assigned to treatment. Missing data was imputed using LOCF method. Here, “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.||Units on a scale||Standard Deviation|Mean
695344|NCT01391507|Secondary|Number of Participants With New York Heart Association (NYHA) Classification of Disease Progression|Disease progression (morbidity) was measured by the NYHA classification. The NYHA classification assesses the severity of symptoms of heart failure as judged by the investigator and is comprised of 4 stages. Stage I- No symptoms/limitation in ordinary physical activity (for example, shortness of breath when walking, climbing stairs); Stage II-Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity; Stage III- Marked limitation in activity due to symptoms, even during less-than-ordinary activity, (for example, walking short distances [20-100 m]), comfortable only at rest; and Stage IV- Severe limitations in activity/experiences symptoms while at rest (mostly bedbound participants).|Baseline and Month 6|ITT population included all participants who were randomly assigned to treatment. Missing data was imputed using LOCF method. Here ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.||Participants|||Number
695345|NCT01391507|Secondary|Change From Baseline in Distance Walked During Six-minute Walk Test at Month 6|A standardized 6-minute walk test was performed and the distance covered in 6 minutes was measured.|Baseline and Month 6|ITT population included all participants who were randomly assigned to treatment. Missing data was imputed using LOCF method.||Meter||Standard Deviation|Mean
695346|NCT01391507|Secondary|Change From Baseline in Central Tissue E-Wave Doppler Mitral Annular Velocity at Month 6|Tissue doppler mitral annular velocity is a measure of how well the heart fills with blood. This was measured by echocardiogram. Most of the values for E-wave were not provided in the reports from central core echocardiographic laboratory due to technical reasons.|Baseline and Month 6|ITT population included all participants who were randomly assigned to treatment. Missing data was imputed using LOCF method. Here, “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.||Centimeter (cm)/ Second (sec)||Standard Deviation|Mean
695347|NCT01391507|Secondary|Change From Baseline in Central Transmitral Flow Velocity Time Integral (VTI) at Month 6|Transmitral flow VTI measures how blood flows through the heart. This was measured by echocardiogram. Most of the values for transmitral flow VTI were not provided in the reports from central core echocardiographic laboratory due to technical reasons.|Baseline and Month 6|ITT population included all participants who were randomly assigned to treatment. Missing data was imputed using LOCF method. Here, “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure. No participants were evaluable for arms COR-1 80 mg and COR-1 160 mg.||Centimeter (cm)||Standard Deviation|Mean
695348|NCT01391507|Secondary|Change From Baseline in N-Terminal Pro B-Type Natriuretic Peptide (NT-ProBNP) Level at Month 6|The NT-ProBNP is a biomarker (a biologic molecule) that has been shown to predict cardiac events.|Baseline and Month 6|ITT population included all participants who were randomly assigned to treatment. Missing data was imputed using LOCF method.||Picogram (pg)/ Milliliter (mL)||Standard Deviation|Mean
695349|NCT01391507|Secondary|Change From Baseline in Local Left Ventricular Ejection Fraction (LVEF) at Month 9|The LVEF is a measure of how much blood is pumped out of the left ventricle of the heart (the main pumping chamber). Ejection fraction percentages greater than (>) 55% are considered normal. It was measured by biplane echocardiography (local assessment).|Baseline and Month 9|ITT population included all participants who were randomly assigned to treatment. Missing data was imputed using LOCF method.||Percentage of blood pumped out||Standard Deviation|Mean
695350|NCT01391507|Primary|Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Month 6|The LVEF is a fraction of blood (in percent) pumped out of the left ventricle of the heart (the main pumping chamber). Ejection fraction percentages greater than (>) 55% are considered normal. It was measured by biplane echocardiography (central assessment).|Baseline and Month 6|Intention-to-treat (ITT) population included all participants who were randomly assigned to treatment. Missing data was imputed using last observation carried forward (LOCF) method.||Percentage of blood pumped out||Standard Deviation|Mean
695351|NCT01391468|Post-Hoc|Change of Serum IL-10 Level at 6 Months|IL-10 is an anti-inflammatory cytokine; The change of serum IL-10 level at 6 months was measured|6 months|||pg/ml||Standard Deviation|Mean
695356|NCT01391013|Secondary|Change From Baseline to Week 48 in Lumbar Z Score: Median Change in Lumbar Z Score|Z score is used to calculate bone mineral density (calcium and other types of minerals) in an area of the bone. Z score is the number of standard deviations above or below the mean for the participant's age, sex and ethnicity. This score is calculated from participant's age, gender and race and skeletal site. Z score has a mean of ‘0’ and a standard deviation of ‘1’. Z score lower than its mean indicate low bone mineral density.|Baseline to Week 48|Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.||Z score||Inter-Quartile Range|Median
695357|NCT01391013|Secondary|Change From Baseline to Week 48 in Lumbar T Score: Median Change in Lumbar T Score|T score is used to calculate bone mineral density (calcium and other types of minerals) in an area of the bone. T score is the number of standard deviations above or below the mean for a healthy 30 year old adult of the same sex and ethnicity as a participant. This score is calculated from participant's age, gender and race and skeletal site. T score has a mean of ‘50’ and a standard deviation of ‘10’. T score lower than its mean indicate low bone mineral density.|Baseline to Week 48|Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.||T score||Inter-Quartile Range|Median
695358|NCT01391013|Secondary|Change From Baseline to Week 48 in Femoral Neck Z Score: Median Change in Femoral Neck Z Score|Z score is used to calculate bone mineral density (calcium and other types of minerals) in an area of the bone. Z score is the number of standard deviations above or below the mean for the participant's age, sex and ethnicity. This score is calculated from participant's age, gender and race and skeletal site. Z score has a mean of ‘0’ and a standard deviation of ‘1’. Z score lower than its mean indicate low bone mineral density.|Baseline to Week 48|Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.||Z score||Inter-Quartile Range|Median
695359|NCT01391013|Secondary|Change From Baseline to Week 48 in Femoral Neck T Score: Median Change in Femoral Neck T Score|T score is used to calculate bone mineral density (calcium and other types of minerals) in an area of the bone. T score is the number of standard deviations above or below the mean for a healthy 30 year old adult of the same sex and ethnicity as a participant. This score is calculated from participant's age, gender and race and skeletal site. T score has a mean of ‘50’ and a standard deviation of ‘10’. T score lower than its mean indicate low bone mineral density.|Baseline to Week 48|Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.||T score||Inter-Quartile Range|Median
695360|NCT01391013|Secondary|Change From Baseline to Week 48 in Visceral Fat Content in Abdomen: Median Change in Visceral Abdominal Tissue (VAT)|Visceral fat content in abdomen will be analyzed with median change in VAT by an abdomen Computerized Tomography.|Baseline to Week 48|Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.||cm square||Inter-Quartile Range|Median
695361|NCT01391013|Secondary|Change From Baseline to Week 48 in Leg Fat Content: Median Change in Leg Fat (Total)|Leg fat content will be analyzed by Dual Energy X-ray Absortiometry (DEXA scan).|Baseline to Week 48|Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.||Percentage of fat||Inter-Quartile Range|Median
695362|NCT01391013|Secondary|Change From Baseline in Mean Framingham Risk Score at Week 24 and Week 48: Medican Change in Framingham Risk Score|The Framingham Risk Score is used to estimate the 10-year cardiovascular risk of a participant. It is calculated according to age, laboratory values of total cholesterol and HDL cholesterol, smoking status, and systolic blood pressure. The framingham risk score is calculated as: for males: 0 point (1 percentage) up to 17 points (30 percentages); whereas for females: 0 to 9 points (1 percentage) up to 25 points (30 percentage). Higher scores indicate high cardiovascular risk.|Baseline, Week 24, and Week 48|Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.||Framingham risk score||Inter-Quartile Range|Median
695363|NCT01391013|Secondary|Change From Baseline in Insulin Sensitivity at Week 24 and Week 48: Median Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)|The Homeostatic Model Assessment (HOMA) is a method used to quantify insulin resistance and beta-cell function. HOMA-IR is reflected in the diminished effect of insulin on hepatic glucose production. HOMA-IR is calculated as: (Glucose [mg/dL] X Insulin [pmol/L]) / (405 X 6.945). Higher scores indicate worse insulin resistance.|Baseline, Week 24, and Week 48|Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.||HOMA score||Inter-Quartile Range|Median
695364|NCT01391013|Secondary|Change From Baseline in Mean Triglycerides at Week 24 and Week 48: Median Change in Triglycerides||Baseline, Week 24, and Week 48|Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.||mg/dL||Inter-Quartile Range|Median
695365|NCT01391013|Secondary|Change From Baseline in Mean High-density Lipoprotein (HDL) Cholesterol at Week 24 and Week 48: Median Change in HDL||Baseline, Week 24, and Week 48|Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.||mg/dL||Inter-Quartile Range|Median
695366|NCT01391013|Secondary|Change From Baseline in Mean Low-density Lipoprotein (LDL) Cholesterol at Week 24 and Week 48: Median Change in LDL||Baseline (Day1 of Week 1), Week 24, and Week 48|Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.||mg/dL||Inter-Quartile Range|Median
695367|NCT01391013|Secondary|Change From Baseline to Week 48 in Precursors of Circulating Endothelial Cells||Baseline to Week 48|Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.||Endothelial cells||Full Range|Median
695368|NCT01391013|Secondary|Change From Baseline to Week 48 in Circulating Endothelial Cells||Baseline to Week 48|Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.||Endothelial cells||Full Range|Median
695369|NCT01391013|Secondary|Number of Participants With a Human Immunodeficiency Virus- Ribonucleic Acid (HIV-RNA) Greater Than or Equal to 50 Copies/mL||Screening (Week -4), Week 1 (Day 1), Week 4, Week 12, Week 24, Week 36, Week 48, and follow-up (Week 52)|Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.||Participants|||Number
695371|NCT01391013|Primary|Change From Baseline to Week 24 in Brachial Artery Flow Mediated Vasodilatation (FMD): Median Change in FMD (%)|Brachial artery FMD is calculated as the percentage increase in brachial artery diameter with hyperemia (an increase in the quantity of blood flow to a body part) induced relative to the resting brachial artery diameter. Percentage of brachial artery diameter is measured as FMD diameter/basal diameter.|Baseline (Day 1 of Week 1) to Week 24|Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.||Percentage of brachial artery diameter||Inter-Quartile Range|Median
695372|NCT01391000|Secondary|Short Form 12-PCS for Quality of Life Assessment|The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health. SF-12 score measures substantially limited physical disability, general well-being and the perception of one's state of health, (Physical Component Summary) and also measure the psychological attitude of the patient, the limitation in social and personal activities (Mental Component Summary). Physical and Mental Health Composite Scores are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.|Change from baseline in quality of life at the end of the rehabilitation cycle (two weeks)|||units on a scale||95% Confidence Interval|Mean
695373|NCT01391000|Secondary|Constant Murley Score for Range of Motion and Shoulder Function Assessment.|The Constant Murley scale had values from 0 to 100 where zero represented the worst possible range of motion and shoulder function and 100 the best.|Change from baseline in range of motion at the end of the rehabilitation cycle (two weeks)|||units on a scale||95% Confidence Interval|Mean
695374|NCT01391000|Primary|Visual Analogue Scale Mean Score|To evaluate the analgesic efficacy of Light Amplification by Stimulated Emission of Radiation carbon dioxide therapy vs Transcutaneous Electrical Nerve Stimulator during the first cycle of rehabilitation through Visual Analogue Scale, calculating the mean score in values of beginning and end of daily treatment. The scale had values from 0 to 10 where zero represented no pain and 10 the worst possible pain. More than 3 means pain.|Change from baseline in pain at the end of the rehabilitation cycle (two weeks)|||units on a scale||95% Confidence Interval|Mean
695389|NCT01390909|Primary|Average Annualized Costs|Average annualized overall healthcare costs and epilepsy-related healthcare costs were calculated for each treatment group. Epilepsy-related costs were those with a code for epilepsy. ED, Emergency Department; AMC, All Medical Costs; Ep Rel, Epilepsy Related. United States dollars were consumer price index adjusted for 2009.|1 year|For Arms 1 - 4, Medicaid-enrolled participants with uncontrolled epilepsy (see Arm Descriptions for Arm Title 1 and Arm Title 3) or matched participants with well-controlled or intermediate epilepsy. For Arms 5 - 8, privately-insured participants with uncontrolled epilepsy or matched participants with well-controlled or intermediate epilepsy.||United States dollars||Standard Deviation|Mean
695390|NCT01390870|Primary|Number of Participants Reporting Compliance With Medication|"Compliance was calculated based on the participant's response to the following question: In general, how many times did you miss taking your prostate medication? Responses were measured on a 5-point scale. Participants who answered I never miss a dose of my medication were considered compliant. All other responses were considered non-compliant."|Cross sectional survey administered once to each participant during a 17-month study period (May 2009 to September 2010)|All enrolled participants taking 5-alpha reductase inhibitors and/or alpha blockers||participants|||Number
695391|NCT01390857|Secondary|Number of Participants Classified as Effective and Not Effective|"The course of symptoms was comprehensively assessed by the investigator on a four-category scale (Improved, Unchanged, Worsen, and Unassessable) before and after the initiation of valaciclovir therapy. “Improved” was regarded as “Effective,” and “Unchanged” and ” Worsen” were regarded as “Not effective. The two participants classifed as “Not effective” were classified as “Unchanged.”"|1 month|Efficacy Analysis Set: all participants assessed for efficacy who completed all study visits; 7 participants did not undergo an efficacy evaluation, and 13 participants failed to visit after the first visit.||participants|||Number
695393|NCT01390857|Secondary|Number of Participants With the Indicated Adverse Drug Reactions|"An adverse drug reaction (ADR) is an adverse event whose causal relationship to study drug was not ruled out by the reporting physician. An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. For a list of all ADRs occurring during the course of the study, please also see the table entitled Other (non-serious) adverse events in the Adverse Event section of the results record."|1 month|ITT Safety Population||participants|||Number
695394|NCT01390857|Primary|Number of Participants With Any Serious Adverse Event|"A serious adverse event is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or results in prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. For a list of all serious adverse events occurring during the course of the study, please see the table entitled Serious Adverse Events in the Adverse Event section of the results record."|1 month|Intent-to-Treat Safety Population: all participants to whom the drug was administered, excluding 10 withdrawal participants.||participants|||Number
695395|NCT01390844|Secondary|Percentage of Participants With an AE of Neutropenia in India|Neutropenia is an abnormally low level of white blood cells (neutrophils). This measure gives the percentage of participants who experienced an occurrence of modified WHO grade 1-4 neutropenia during the treatment phase. A higher grade indicates a higher degree of neutropenia. This table summarizes the worst category observed within the period for each participant.|Up to 96 weeks|APaT - population consists of all randomized participants in India who received ≥ 1 dose of study treatment, corresponding to the study treatment they actually received. Only participants with at least one treatment value for a given laboratory test are included; participants who did not demonstrate GCP compliance were excluded from analysis.||Percentage of Participants|||Number
695396|NCT01390844|Secondary|Percentage of Participants With an AE of Neutropenia in Korea and Taiwan|Neutropenia is an abnormally low level of white blood cells (neutrophils). This measure gives the percentage of participants who experienced an occurrence of modified WHO grade 1-4 neutropenia during the treatment phase. A higher grade indicates a higher degree of neutropenia. This table summarizes the worst category observed within the period for each participant.|Up to 96 weeks|APaT - population consists of all randomized participants in Korea and Taiwan who received at least one dose of study treatment, corresponding to the study treatment they actually received. Only participants with at least one treatment value for a given laboratory test are included.||Percentage of Participants|||Number
695397|NCT01390844|Secondary|Percentage of Participants With an AE of Anemia in India|Anemia is a condition in which the number of red blood cells (hemoglobin) is insufficient to meet the body's physiologic needs. This measure gives the percentage of participants who experienced an occurrence of modified WHO grade 1-4 anemia during the treatment period. A higher grade indicates a higher degree of anemia. This table summarizes the worst category observed within the period per participant per laboratory test (i.e., the lowest value for the hemotologic parameters).|Up to 96 weeks|APaT - population consists of all randomized participants in India who received ≥ 1 dose of study treatment, corresponding to the study treatment they actually received. Only participants with at least one treatment value for a given laboratory test are included; participants who did not demonstrate GCP compliance were excluded from analysis.||Percentage of Participants|||Number
695398|NCT01390844|Secondary|Percentage of Participants With an Adverse Event (AE) of Anemia in Korea and Taiwan|Anemia is a condition in which the number of red blood cells or hemoglobin concentration is insufficient to meet the body's physiologic needs. This measure gives the percentage of participants who experienced an occurrence of modified World Health Organization (WHO) grade 1-4 anemia during the treatment period. A higher grade indicates a higher degree of anemia. This table summarizes the worst category observed within the period per participant per laboratory test (i.e., the lowest value for the hemotologic parameters).|Up to 96 weeks|All Participants as Treated (APaT) - population consists of all randomized participants in Korea and Taiwan who received at least one dose of study treatment, corresponding to the study treatment they actually received. Only participants with at least one treatment value for a given laboratory test are included.||Percentage of Participants|||Number
695399|NCT01390844|Secondary|Percentage of Participants in India Achieving EVR at Treatment Week 8|Percentage of participants achieving early virologic response (undetectable HCV-RNA at Treatment Week 8)|Treatment Week 8|FAS - population includes all randomized participants who received at least one (1) dose of any study medication (i.e., PEG, RBV, or BOC); participants who did not demonstrate GCP compliance were excluded from analysis.||Percentage of Participants|||Number
695400|NCT01390844|Secondary|Percentage of Participants in Korea and Taiwan Achieving Early Virologic Response (EVR) at Treatment Week 8|Percentage of participants achieving early virologic response (undetectable HCV-RNA at Treatment Week 8)|Treatment Week 8|FAS - population includes all randomized participants who received at least one (1) dose of any study medication (i.e., PEG, RBV, or BOC).||Percentage of Participants|||Number
695401|NCT01390844|Secondary|Percentage of Participants in India With SVR at Follow-Up Week 24 - mITT Population|SVR is defined as undetectable plasma HCV-RNA at FW24. If FW24 is missing and other HCV-RNA values after FW24 are available, the last available value would be used for FW24. The LOCF method was used to impute missing values; if a participant is missing at and after FW24 and has FW12 data, then FW12 data will be carried forward to FW24. Cross-over participants are considered as non-responders in SVR.|Follow-up Week 24|mITT - population includes all randomized participants who received at least one (1) dose of experimental study drug (i.e., BOC for the Experimental Arm or placebo for the Control Arm); participants who did not demonstrate GCP compliance were excluded from analysis.||Percentage of Participants|||Number
695402|NCT01390844|Secondary|Percentage of Participants in Korea and Taiwan With SVR at Follow-Up Week 24 - Modified Intent-to-Treat (mITT) Population|SVR is defined as undetectable plasma HCV-RNA at FW24. If FW24 is missing and other HCV-RNA values after FW24 are available, the last available value would be used for FW24. The LOCF method was used to impute missing values; if a participant is missing at and after FW24 and has FW12 data, then FW12 data will be carried forward to FW24. Cross-over participants are considered as non-responders in SVR.|Follow-up Week 24|mITT - population includes all randomized participants who received at least one (1) dose of experimental study drug (i.e., BOC for the Experimental Arm or placebo for the Control Arm).||Percentage of Participants|||Number
703393|NCT00094900|Secondary|Mean Change in Ferritin|Ferritin level change from baseline to 6 months|6 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||mcg/L||Standard Error|Mean
695403|NCT01390844|Primary|Percentage of Participants in India With SVR at Follow-Up Week 24 - FAS Population|SVR is defined as undetectable plasma HCV-RNA at FW24. If FW24 is missing and other HCV-RNA values after FW24 are available, the last available value would be used for FW24. The LOCF method was used to impute missing values; if a participant is missing at and after FW24 and has FW12 data, then FW12 data will be carried forward to FW24. Cross-over participants are considered as non-responders in SVR.|Follow-up Week 24|FAS - population includes all randomized participants who received at least one (1) dose of any study medication (i.e., PEG, RBV, or BOC); participants who did not demonstrate GCP compliance were excluded from analysis.||Percentage of Participants|||Number
695404|NCT01390844|Primary|Percentage of Participants in Korea and Taiwan With Sustained Virologic Response (SVR) at Follow-Up Week 24 - Full Analysis Set (FAS) Population|SVR is defined as undetectable plasma HCV-RNA at Follow-up Week (FW) 24. If FW24 is missing and other HCV-RNA values after FW24 are available, the last available value would be used for FW24. The last observation carried forward (LOCF) method was used to impute missing values; if a participant is missing at and after FW24 and has FW12 data, then FW12 data will be carried forward to FW24. Cross-over participants are considered as non-responders in SVR.|Follow-up Week 24|FAS - population includes all randomized participants who received at least one (1) dose of any study medication (i.e., PEG, RBV, or BOC).||Percentage of Participants|||Number
695405|NCT01390818|Secondary|Number of Subjects With Complete Tumor Response (CR), Partial Tumor Response (PR), or Stable Disease (SD)|CR=Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeter (mm). PR=At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. PD= At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.|From the date of randomisation every 6 weeks up to assessed up to 4 years|The Efficacy Analysis Set (EEF) included all subjects who received at least 1 trial treatment dose (Pimasertib or SAR245409) and had radiographic baseline and at least one evaluable post baseline tumor assessment.||subjects|||Number
695406|NCT01390818|Secondary|pERK Concentrations in PBMCs|"pERK Concentrations in PBMCs was measured during DDI Evaluation period and Cycle 1 for DE cohorts. DDI evaluation period is a 4-day period that was performed within 1 week prior to Day 1 Cycle 1. In DDI evaluation period, On Day 1, SAR245409 was be administered alone, and on Day 3, Pimasertib was administered alone. No data were planned to be collected for Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily, Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily, Pimasertib (MSC1936369) 30mg and SAR245409 70mg Once Daily and Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily reporting arms."|DDI Evaluation: Day 1 and 3 (predose, 2, 4, 8 and 24 hours (hr) postdose); Day 2 and 4 (24 hr postdose); C1D1 and C1D15 (predose, 2, 4, 8, 24 hr postdose); C1D2 and C1D16 (24 hr postdose); C1D19 (predose, 2 hr postdose)|Biomarker Analysis Set for pharmacodynamics marker analysis in PBMC included all subjects who received at least first dose of both drugs and had provided at least one pre-dose sample and one post-dose sample. Here “N” signifies number of subject analysed for this outcome measure” and “n” signifies number of subject analysed at specific time point.||fluorescence intensity||Standard Deviation|Mean
695407|NCT01390818|Secondary|pS6 Concentrations in Peripheral Blood Mononuclear Cells (PBMCs)|"pS6 Concentrations in PBMCs was measured during DDI Evaluation period and Cycle 1 for DE cohorts. DDI evaluation period is a 4-day period that was performed within 1 week prior to Day 1 Cycle 1. In DDI evaluation period, On Day 1, SAR245409 was be administered alone, and on Day 3, Pimasertib was administered alone. No data were planned to be collected for Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily, Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily, Pimasertib (MSC1936369) 30mg and SAR245409 70mg Once Daily and Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily reporting arms."|DDI Evaluation: Day 1 and 3 (predose, 2, 4, 8 and 24 hours (hr) postdose); Day 2 and 4 (24 hr postdose); Cycle 1 Day 1 (C1D1) and C1D15 (predose, 2, 4, 8, 24 hr postdose); C1D2 and C1D16 (24 hr postdose); C1D19 (predose, 2 hr postdose)|The Biomarker Analysis Set for pharmacodynamics (PD) marker analysis in PBMC included all subjects who received at least the first dose of both drugs and had provided at least one pre-dose sample and one post-dose sample. Here “n” signifies the number of subjects evaluable at the specific time points.||fluorescence intensity||Standard Deviation|Mean
695408|NCT01390818|Secondary|Accumulation Ratio (Racc) for Cmax of SAR245409: Day 15|Accumulation ratio (Racc) for Cmax, calculated as Day 15 Cmax divided by Day 1 Cmax.|Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts|"The PK analysis set. Here N signifies number of participant analyzed for this outcome measure and “n” signifies the number of subjects evaluable at the specific time points."||Ratio||95% Confidence Interval|Geometric Mean
695409|NCT01390818|Secondary|Accumulation Ratio (Racc) for AUCtau of SAR245409: Day 15|Accumulation ratio (Racc) for AUCtau, calculated as Day 15 dosing interval AUCtau divided by Day 1 dosing interval AUCtau.|Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts|"The PK analysis set. Here N signifies number of participant analyzed for this outcome measure and “n” signifies the number of subjects evaluable at the specific time points."||ratio||95% Confidence Interval|Geometric Mean
695410|NCT01390818|Secondary|Apparent Volume of Distribution of Total SAR245409 During the Terminal Phase Following Oral Administration (Vz/f)|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/f) was influenced by the fraction absorbed. Apparent volume of distribution during the terminal phase, calculated by CL/f/λz. Terminal rate constant (λz). The regression analysis (determination of λz) was to contain as many data points as possible (but excluding Cmax) and had to include concentration data from at least 3 different time points, consistent with the assessment of a straight line (the terminal elimination phase) on the log-transformed scale.|Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts|The PK analysis set. Here “n” signifies the number of subjects evaluable at the specific time points.||litre||95% Confidence Interval|Geometric Mean
695411|NCT01390818|Secondary|Total Body Clearance (CL/f) of SAR245409|The total body clearance of drug from plasma following oral administration (Cl/f) and the total body clearance of drug from plasma following intravenous administration was calculated by dividing the dose with area under the plasma concentration time curve from time zero to infinity (AUC 0-inf)=Dose/AUC 0-inf.|Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts|The PK analysis set. Here “n” signifies the number of subjects evaluable at the specific time points.||litre per hour||95% Confidence Interval|Geometric Mean
695412|NCT01390818|Secondary|Apparent Terminal Half-Life (t1/2) of SAR245409||Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts|The PK analysis set. Here “n” signifies the number of subjects evaluable at the specific time points.||hour||Full Range|Median
695413|NCT01390818|Secondary|Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to Infinity (0-inf) of SAR245409: Day 1|"Area under the concentration-time curve from time 0 extrapolated to infinity, calculated as AUC0-t + last observed concentration (Clast)/terminal rate constant (λz), using the Linear up/Log down method.
Terminal rate constant (λz). The regression analysis (determination of λz) was to contain as many data points as possible (but excluding Cmax) and had to include concentration data from at least 3 different time points, consistent with the assessment of a straight line (the terminal elimination phase) on the log-transformed scale."|Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1 for DE cohorts|"The PK analysis set. Here N signifies number of subjects evaluable for this outcome measure and “n” signifies the number of subjects evaluable at the specific time points."||hr*ng/mL||95% Confidence Interval|Geometric Mean
695414|NCT01390818|Secondary|Area Under the Concentration-Time Curve (AUC) During a Dosing Interval (Tau) of SAR245409||Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts|The PK analysis set. Here “n” signifies the number of subjects evaluable at the specific time points.||hr*ng/mL||95% Confidence Interval|Geometric Mean
695415|NCT01390818|Secondary|Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to the Last Sampling Time (0-24 Hours) of SAR245409|Area under the plasma concentration-time curve (AUC) from time zero to the last sampling time (0-24 hours) at which the concentration is at or above the lower limit of quantification. Unit of assessment was hour*nanogram per milliliter (hr*ng/mL).|Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts|The PK analysis set. Here “n” signifies the number of subjects evaluable at the specific time points.||hr*ng/mL||95% Confidence Interval|Geometric Mean
695416|NCT01390818|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of SAR245409|The time to reach maximum plasma concentration (Tmax) of SAR245409 was calculated.|Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts|The PK analysis set. Here “n” signifies the number of subjects evaluable at the specific time points.||hours||Full Range|Median
695417|NCT01390818|Secondary|Maximum Observed Plasma Concentration (Cmax) for SAR245409||Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts|The PK analysis set. Here “n” signifies the number of subjects evaluable at the specific time points.||nanogram per millilitre (ng/mL)||95% Confidence Interval|Geometric Mean
695418|NCT01390818|Secondary|Accumulation Ratio (Racc) for Cmax of Pimasertib (MSC1936369B): Day 15|Accumulation ratio (Racc) for Cmax, calculated as Day 15 Cmax/Day 1 Cmax.|Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts|"The PK analysis set. Here N signifies number of subjects evaluable for this outcome measure and “n” signifies the number of subjects evaluable at the specific time points."||ratio||95% Confidence Interval|Geometric Mean
695419|NCT01390818|Secondary|Accumulation Ratio (Racc) for AUCtau of Pimasertib (MSC1936369B): Day 15|Accumulation ratio (Racc) for AUCtau, calculated as Day 15 dosing interval AUCtau per Day 1 dosing interval AUCtau.|Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts|"The PK analysis set. Here N signifies number of subjects evaluable for this outcome measure and “n” signifies the number of subjects evaluable at the specific time points."||ratio||95% Confidence Interval|Geometric Mean
695420|NCT01390818|Secondary|Apparent Volume of Distribution of Total Pimasertib During the Terminal Phase Following Oral Administration (Vz/f) of Pimasertib|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/f) was influenced by the fraction absorbed. Apparent volume of distribution during the terminal phase, calculated by CL/f/λz. Terminal rate constant (λz). The regression analysis (determination of λz) was to contain as many data points as possible (but excluding Cmax) and had to include concentration data from at least 3 different time points, consistent with the assessment of a straight line (the terminal elimination phase) on the log-transformed scale.Data was not available for 'Pimasertib (MSC1936369B) 60mg Twice Daily' arm as no subjects were considered evaluable because of limited number of samples collected to characterize the terminal phase rate constant needed for the calculation of Vz/f.|Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts|"The PK analysis set. Here N signifies number of subjects evaluable for this outcome measure and “n” signifies the number of subjects evaluable at specific time points."||liter||95% Confidence Interval|Geometric Mean
695421|NCT01390818|Secondary|Total Body Clearance (CL/f) of Pimasertib (MSC1936369B)|The total body clearance of drug from plasma following oral administration (Cl/f) and the total body clearance of drug from plasma following intravenous administration was calculated by dividing the Dose with area under the plasma concentration time curve from time zero to infinity (AUC0 inf)=Dose/AUC0- inf.|Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts|"The PK analysis set. Here N signifies number of subjects evaluable for this outcome measure and “n” signifies the number of subjects evaluable at the specific time points."||litre per hour (L/hr)||95% Confidence Interval|Geometric Mean
695423|NCT01390818|Secondary|Area Under the Concentration-Time Curve (AUC) During a Dosing Interval (Tau) of Pimasertib (MSC1936369B)||Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts|The PK analysis set. Here “n” signifies the number of subjects evaluable at the specific time points.||hr*ng/mL||95% Confidence Interval|Geometric Mean
695424|NCT01390818|Secondary|Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC 0-inf) of Pimasertib (MSC1936369B) at Day 1|"Area under the concentration-time curve from time 0 extrapolated to infinity, calculated as AUC0-t + last observed concentration (Clast)/terminal rate constant (λz), using the Linear up/Log down method.
Terminal rate constant (λz)."|Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1 for DE cohorts|"The PK analysis set. Here N signifies the number of subjects evaluable for this outcome measure. Data was not available for 'Pimasertib (MSC1936369B) 60mg Twice Daily' arm as no subjects were considered evaluable because of limited number of samples collected to characterize the terminal phase rate constant needed for the calculation of AUCinf."||hr*ng/mL||95% Confidence Interval|Geometric Mean
695425|NCT01390818|Secondary|Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to the Last Sampling Time (0-24 Hours) of Pimasertib (MSC1936369B)|Area under the concentration-time curve from time 0 to the last quantifiable concentration.|Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts|"The PK analysis set . Here n signifies the number of subjects evaluable at the specific time points."||hour*nanogram per millilitre (hr*ng/mL)||95% Confidence Interval|Geometric Mean
695426|NCT01390818|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Pimasertib (MSC1936369B)||Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts|"The PK analysis set. Here n signifies the number of subjects evaluable at the specific time points."||hour||Full Range|Median
695427|NCT01390818|Secondary|Maximum Observed Plasma Concentration (Cmax) for Pimasertib (MSC1936369B)||Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts|The pharmacokinetic (PK) analysis set. Here “n” signifies the number of subjects evaluable at the specific time points.||nanogram/millilitre (ng/mL)||95% Confidence Interval|Geometric Mean
695428|NCT01390818|Secondary|Number of Subjects Experiencing Any Treatment-Emergent Adverse Events (TEAEs)|An adverse event (AE) was defined as any untoward medical occurrence in a subject administered a pharmaceutical product, which did not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs were defined as those AEs that started between first dose of study drug and up to 30 days after last dose.|Baseline up to 30 Days after last dose; assessed up to 4 years|The safety analysis set (SAF) analysis set was to include all subjects who had received at least 1 (non-zero) administration of the trial investigational medicinal products (IMPs) MSC1936369B (pimasertib) and/or SAR245409.||subjects|||Number
695429|NCT01390818|Primary|Number of Subjects With Dose Limiting Toxicities (DLT)|DLT was defined as any of the following toxicities experienced during the first cycle of treatment at any dose level (DL) and judged not to be related to the underlying disease or any concomitant medication by the Investigator and/or the Sponsor: A treatment emergent adverse event (TEAE) of potential clinical significance such that further dose escalation (DE) would have exposed subjects to unacceptable risk. Any Grade greater than or equal to (>=) 3 non-hematological toxicity, except for: Grade 3 diarrhea, nausea and vomiting with a duration less than or equal to (<=) 48 hours despite adequate supportive care and Alopecia. Grade 4 neutropenia of > 5 days duration or febrile neutropenia. Grade 3 thrombocytopenia with bleeding or Grade 4 thrombocytopenia. Any treatment interruption > 2 weeks due to AEs not related to the underlying disease or concomitant medication at any dose level and any severe, life-threatening impairing daily functions complication or abnormality.|Day 1 up to Day 16 in cycle 1|The dose escalation (DE) analysis set included all subjects treated in DE cohorts who received at least 80 percent (%) of pimasertib and 80% of SAR245409 full planned doses in the first cycle (ie, 21-day period from Day 1) of treatment or who experienced a DLT during the first cycle of treatment regardless of the received amount of each drug.||subjects|||Number
695430|NCT01390779|Primary|SENSIMED Triggerfish Efficacy|Device's ability to detect ocular pulse frequency concurrent to heart rate, defined as the number of SENSIMED Triggerfish recording intervals showing oscillation at a frequency matching that of heart rate +/- 15%. In absence of eye blinks during sleep, an oscillating pattern is recorded. The frequency of oscillation was determined by independent reviewers for selected SENSIMED Triggerfish 30-second recording intervals for which simultaneous or close to simultaneous heart rate data was recorded. Intervals for which the oscillation frequency on SENSIMED Triggerfish pattern matched heart rate +/- 15% (tolerance due to noise caused by eye and lid movements) were considered accurate. The percentage of accurate intervals was calculated and expected to be at least 75%.|in selected 30-second SENSIMED Triggerfish recording intervals during sleep|One subject was excluded from the analysis due to the absence of a 3-mmHg difference in IOP from wake to sleep. Two subjects were excluded since they had less than 80% of expected SENSIMED Triggerfish data. One subject was excluded from the analysis due to an invalid SENSIMED Triggerfish recording.||% of accurate recording intervals||95% Confidence Interval|Number
695431|NCT01390779|Primary|SENSIMED Triggerfish Efficacy|"Investigate the device's capacity to detect changes in IOP from wake to sleep, defined as a significantly positive slope on the SENSIMED Triggerfish recording (obtained on one eye in each subject), based on the established phenomenon that IOP increases from waking to sleep hours. The IOP from wake to sleep was measured in the eye contralateral to that of SENSIMED Triggerfish using pneumatonomtery. Subjects were included in the primary analysis if a difference in IOP of at least 3 mmHg was detected from wake to sleep.
One subject was excluded from the analysis due to the absence of a 3-mmHg difference in IOP from wake to sleep. Two subjects were excluded since they had less than 80% of expected SENSIMED Triggerfish data. One subject was excluded from the analysis due to an invalid SENSIMED Triggerfish recording."|from 1 hour before sleep to 1 hour after sleep|Subjects were included in this analysis if the difference in IOP from wake to sleep was at least 3 mmHg, as determined using pneumatonometry on the eye contralateral to that of SENSIMED Triggerfish, and if the SENSIMED Triggerfish recording contained at least 80% of the expected data points.||mV/h||Standard Deviation|Mean
695432|NCT01390649|Secondary|Responder Rate|The responder rate is the percentage of subjects who have a platelet response (defined as a platelet count increase at least once to ≥ 50 x 10^9/L after the first IgPro10 administration).|Within 6 days after the first infusion|Full analysis set: all subjects who received at least 1 IgPro10 infusion.||percentage of participants||95% Confidence Interval|Number
695433|NCT01390649|Primary|Set of Antibodies Most Frequently Bound to Red Blood Cells (RBCs) in Subjects Experiencing Clinically Significant Intravascular Hemolysis|The occurrence of clinically significant intravascular hemolysis was determined by an independent Adjudication Committee. No subject experienced clinically significant intravascular hemolysis; therefore, the primary safety endpoint could not be analyzed.|Within 3 days of infusion||||||
695434|NCT01390441|Primary|Number of Participants Positive for Anti-Drug Antibody (ADA) Formation in the Extension Study|Serum ADA positivity is determined over course of therapy with MK-8808 in the Extension Study.|Week 54, Week 56, Week 68, Week 80, Week 82, Week 94, Week 106|The analysis was not performed due to early termination of the study after Part A. Blood sampling in the Extension Study was performed without further laboratory quantification for this outcome measure.|||||
695435|NCT01390441|Primary|Number of Participants With Immunoglobulin G (IgG) Response in the Extension Study|Serum IgG levels are determined over course of therapy with MK-8808 in the Extension Study.|Week 54, Week 68, Week 80, Week 94, Week 106|The analysis was not performed due to early termination of the study after Part A. Blood sampling in the Extension Study was performed without further laboratory quantification for this outcome measure.|||||
695436|NCT01390441|Other Pre-specified|Change From Baseline in Disease Activity in 28 Joints C-Reactive Protein Score (DAS28-CRP) by Time-point|The DAS28-CRP is a combination scoring method for function using the European League against Rheumatism (EULAR) 28 joint count and the CRP value. The DAS28-CRP scores range from 2.0 to 10.0 with higher values indicating a higher disease activity. A DAS28-CRP below the score of 2.6 is interpreted as Remission. CRP values below lower limit of quantification (LLQ) (<0.4 mg/dL) were set to 0.2 mg/dL in the calculation of DAS28-CRP.|Baseline, Week 6, Week 12|FAS defined as all randomized participants who received at least one complete treatment course (2 doses) and had at least one post-treatment measurement. Patients were included in the treatment group to which they were randomized. A patient might have been be excluded from the FAS population for a given endpoint for multiple reasons.||Score||Standard Deviation|Mean
695437|NCT01390441|Other Pre-specified|Part B: Number of ACR20, ACR50, and ACR70 Responders at Week 24|"American College of Rheumatology (ACR) Responder Index is based on a set of evaluations: the Investigator Tender Joint Count/Number of Tender Joints (out of 68 Joints); Investigator Swollen Joint Count/Number of Swollen Joints (out of 66 Joints); Patient Global Assessment of Disease Activity (PGAD); Investigator Global Assessment of Disease Activity (IGAD); Patient Global Assessment of Pain (PGAP); Health Assessment Questionnaire Disability Index (HAQ-DI); and ESR. ACR response indicates percent change (ie, improvement) from baseline (20%, 50%, 70%) PGAD & IGAD: assessment of function on a 4-point Likert scale: 0=very well to 3=unable to do PGAP: pain due to arthritis measured on a 0-100 mm visual analog scale: Left hand marker-no pain; right hand marker-extreme pain HAQ-DI: assessment of 8 daily living activities (dress/groom; arise; eat; walk; reach; grip; hygiene; common daily activities) on 4-point Likert scale: 0=no difficulty to 3=unable to do"|Week 24|FAS defined as all randomized participants who received at least one complete treatment course (2 doses) and had at least one post-treatment measurement. Patients were included in the treatment group to which they were randomized. A patient might have been be excluded from the FAS population for a given endpoint for multiple reasons.||Participants|||Number
695438|NCT01390441|Other Pre-specified|Part A: Number of ACR20, ACR50, and ACR70 Responders at Week 24|"American College of Rheumatology (ACR) Responder Index is based on a set of evaluations: the Investigator Tender Joint Count/Number of Tender Joints (out of 68 Joints); Investigator Swollen Joint Count/Number of Swollen Joints (out of 66 Joints); Patient Global Assessment of Disease Activity (PGAD); Investigator Global Assessment of Disease Activity (IGAD); Patient Global Assessment of Pain (PGAP); Health Assessment Questionnaire Disability Index (HAQ-DI); and ESR. ACR response indicates percent change (ie, improvement) from baseline (20%, 50%, 70%) PGAD & IGAD: assessment of function on a 4-point Likert scale: 0=very well to 3=unable to do PGAP: pain due to arthritis measured on a 0-100 mm visual analog scale: Left hand marker-no pain; right hand marker-extreme pain HAQ-DI: assessment of 8 daily living activities (dress/groom; arise; eat; walk; reach; grip; hygiene; common daily activities) on 4-point Likert scale: 0=no difficulty to 3=unable to do"|Week 24|Full Analysis Set defined as all randomized participants who received at least one complete treatment course (2 doses) and had at least one post-treatment measurement. Patients were included in the treatment group to which they were randomized. A patient might have been be excluded from the FAS population for a given endpoint for multiple reasons.||Participants|||Number
695439|NCT01390441|Secondary|Part B: Cmax After the Second Infusion of a Single Course of Treatment|Cmax is a measure of the maximum plasma concentration of drug; samples are collected on Day 15 after the second infusion of the first course of treatment.|Day 15|PK analysis for Part B was not performed due to early termination of the study after Part A. Blood sampling in Part B was performed without further laboratory quantification for this outcome measure.|||||
695440|NCT01390441|Secondary|Part A: Maximum Concentration (Cmax) After the Second Infusion of a Single Course of Treatment|Cmax is a measure of the maximum plasma concentration of drug; samples are collected on Day 15 after the second infusion of the first course of treatment. Descriptive data values and associated dispersion measures (confidence intervals) are expressed in terms of the factor 10E3.|Day 15|Participants who completed a full course of MK-8808 or MabThera® (two full doses of 500 mg/m^2 on Days 1 and 15); had no major protocol violations; had a complete PK profile; had serum MK-8808 or MabThera® concentrations prior to the first dose of the first course not exceeding 5% of Cmax after the first dose of the first course.||ng/mL||95% Confidence Interval|Geometric Mean
695441|NCT01390441|Primary|Number of Participants Who Discontinued Study Drug Due to Adverse Events|Discontinuation/withdrawal of study treatment due to an adverse event was performed at the discretion of the investigator or the Sponsor for safety concerns. An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.|Parts A and B: Up to Week 28; Extension A and B: Up to 82 weeks|APaT population defined as all participants who received at least one dose of study drug.||Participants|||Number
695442|NCT01390441|Primary|Number of Participants Who Experienced at Least One Adverse Event|An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.|Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks|All Participants as Treated (APaT) population defined as all participants who received at least one dose of study drug.||Participants|||Number
695443|NCT01390441|Primary|Part B: Area Under the Concentration-time Curve From Day 0 to Day 84 (AUC0-84day) After a Single Course of Treatment|AUC is a measure of the amount of drug in the plasma over time; samples are collected at intervals from pre-dose up to 84 days after the dose.|Day 1 (pre- and post-dose), Day 3, Day 5, Day 8, Day 15, Day 17, Day 19, Day 22, Day 29, Day 43, Day 57, Day 85|PK analysis for Part B was not performed due to early termination of the study after Part A. Blood sampling in Part B was performed without further laboratory quantification for this outcome measure.|||||
695444|NCT01390441|Primary|Part A: Area Under the Concentration-time Curve From Day 0 to Day 84 (AUC0-84day) After a Single Course of Treatment|AUC is a measure of the amount of drug in the plasma over time; samples are collected at intervals from pre-dose up to 84 days after the dose. Descriptive data values and associated dispersion measures (confidence intervals) are expressed in terms of the factor 10E6.|Day 1 (pre- and post-dose), Day 3, Day 5, Day 8, Day 15, Day 17, Day 19, Day 22, Day 29, Day 43, Day 57, Day 85|Participants who completed a full course of MK-8808 or MabThera® (two full doses of 500 mg/m^2 on Days 1 and 15), had no major protocol violations, had a complete pharmacokinetic (PK) profile, had serum MK-8808 or MabThera® concentrations prior to the first dose of the first course not exceeding 5% of Cmax after the first dose of the first course||hr*mg/mL||95% Confidence Interval|Geometric Mean
695445|NCT01390428|Primary|Apparent Terminal Half-life (t1/2) of Grazoprevir|Blood samples were collected at pre-dose, and from 0.5 to 24 hours post-dose on Day 10 in order to determine the plasma t1/2 of Grazoprevir. Classification of HI based on the Child-Pugh scale, where a score of 5-6 = Mild HI; a score of 7-9 = Moderate HI; and a score of 10-15 = Severe HI.|Day 10 at the following timepoints: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose|Participants who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model.||hr.||Geometric Coefficient of Variation|Geometric Mean
695446|NCT01390428|Primary|Concentrations 24 Hours Post-dose (C24) of Grazoprevir on Day 10|Blood samples were collected at 24 hours post-dose on Day 10 in order to determine the plasma C24 of Grazoprevir. Classification of HI based on the Child-Pugh scale, where a score of 5-6 = Mild HI; a score of 7-9 = Moderate HI; and a score of 10-15 = Severe HI.|Days 10 at 24 hours postdose|Participants who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model.||nM||95% Confidence Interval|Geometric Mean
695447|NCT01390428|Primary|Concentrations 24 Hours Post-dose (C24) of Grazoprevir on Day 1 for Participants With Severe HI and Healthy Matched to Severe HI|Blood samples were collected at 24 hours post-dose on Day 1 in order to determine the plasma C24 of Grazoprevir. Classification of HI based on the Child-Pugh scale, where a score of 5-6 = Mild HI; a score of 7-9 = Moderate HI; and a score of 10-15 = Severe HI.|Day 1 at 24 hours postdose|Participants who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Participants with Mild HI, Moderate HI and Healthy Matched to Mild HI or Moderate HI are absent because they had a different Measure Type and Method of Dispersion||nM||Full Range|Median
695448|NCT01390428|Primary|Concentrations 24 Hours Post-dose (C24) of Grazoprevir on Day 1 for Participants With Mild HI and Moderate HI and Healthy Matched to Mild HI and Moderate HI|Blood samples were collected at 24 hours post-dose on Day 1 in order to determine the plasma C24 of Grazoprevir. Classification of HI based on the Child-Pugh scale, where a score of 5-6 = Mild HI; a score of 7-9 = Moderate HI; and a score of 10-15 = Severe HI.|Day 1 at 24 hours postdose|Participants who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Participants with Severe HI and Matched Healthy to Severe HI are absent because they had a different Measure Type and Method of Dispersion||nM||95% Confidence Interval|Geometric Mean
695449|NCT01390428|Primary|Time to Peak Concentration (Tmax) of Grazoprevir|Blood samples were collected at pre-dose, and from 0.5 to 24 hours post-dose on Days 1 and 10 in order to determine the plasma Tmax of Grazoprevir. Classification of HI based on the Child-Pugh scale, where a score of 5-6 = Mild HI; a score of 7-9 = Moderate HI; and a score of 10-15 = Severe HI.|Days 1 and 10 at the following timepoints: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose|Participants who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model.||hr.||Full Range|Median
695450|NCT01390428|Primary|Maximum Concentration (Cmax) of Grazoprevir|Blood samples were collected at pre-dose, and from 0.5 to 24 hours post-dose on Days 1 and 10 in order to determine the plasma Cmax of Grazoprevir. Classification of HI based on the Child-Pugh scale, where a score of 5-6 = Mild HI; a score of 7-9 = Moderate HI; and a score of 10-15 = Severe HI.|Days 1 and 10 at the following timepoints: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose|Participants who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model.||uM||95% Confidence Interval|Geometric Mean
695451|NCT01390428|Primary|Area Under the Concentration Time-curve From 0 to 24 Hours (AUC0-24) of Grazoprevir|Blood samples were collected at pre-dose, and from 0.5 to 24 hours post-dose on Days 1 and 10 in order to determine the plasma AUC0-24 of Grazoprevir. Classification of HI based on the Child-Pugh scale, where a score of 5-6 = Mild HI; a score of 7-9 = Moderate HI; and a score of 10-15 = Severe HI.|Days 1 and 10 at the following timepoints: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose|Participants who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model.||uM*hr||95% Confidence Interval|Geometric Mean
695452|NCT01390415|Secondary|Diastolic Blood Pressure (DBP)|DBP at baseline and month 6.|Baseline and Month 6|||mmHg||Standard Deviation|Mean
695453|NCT01390415|Secondary|Systolic Blood Pressure (SBP)|SBP at baseline and month 6.|Baseline and Month 6|||mmHg||Standard Deviation|Mean
710606|NCT00165698|Primary|Bone Mineral Density BMD (Percentage) Change in Collum Femoris After 12 Months||Baseline and 12 months|Per Protocol Set (PPS)||percentage of BMD||Full Range|Median
695455|NCT01390402|Primary|Number of Participants With Molecular Complete Remission at 3 Month Post Transplant|Molecular Complete Remission is defined as participant alive and engrafted with molecular complete remission 100 days post transplant where molecular complete response is no BCR-ABL transcripts detected and engraftment is defined as the evidence of donor derived cells (more than 95%) by chimerism studies in the presence of neutrophil recovery by day 28 post stem cell infusion.|Baseline to up to 4 months post-transplant|||participants|||Number
695458|NCT01390259|Secondary|Mean Glucose|Average plasma glucose concentration in mg/dl|22 hours|||mg/dL||Standard Error|Mean
695459|NCT01390259|Secondary|Percent Time in Euglycemia|Percent of time the patient plasma glucose as measured by YSI is between 70mg/dl and 180mg/dl|22 hours|||percentage of time in range||Standard Error|Mean
695460|NCT01390259|Primary|Hypoglycemic Events|"Number of hypoglycemic events below 70 mg/dL per patient per day
Hypoglycemic event is defined as consecutive YSI plasma glucose measurements below 70 or moderate hypoglycemic symptoms"|22 hours|||events/patient||Standard Error|Mean
695461|NCT01390233|Primary|Vaginal Delivery|The primary outcome of this study is vaginal delivery of a liveborn singleton pregnancy. The outcome is considered a vaginal delivery if accomplished by spontaneous vaginal delivery, operative forceps or vacuum forceps. The alternate outcome is delivery by cesarean section.|Gestational age 26-42 weeks|||participants|||Number
695462|NCT01390181|Primary|Inflammatory Markers Levels|Changes in levels of Matrix Metalloproteinase (MMP-2, MMP-9), Tissue Inhibitor of Metalloproteinases (TIMP 1, TIMP 2), & Transforming Growth Factor-Beta (TGFB) in circulation while taking medication from baseline at 3 months, 6 months and 12 months. The 12 month levels were the primary outcome.|Baseline and 12 months|No participants were analyzed because the study terminated prior to data collection for final primary outcome measure.|||||
695463|NCT01390038|Secondary|Pain: Visual Analog Scale|0 (best) - 10 (worst)|24 Months|||units on a scale||Standard Deviation|Mean
695464|NCT01390038|Secondary|American Shoulder and Elbow Surgeon Score|0 (worst) - 100 (best)|24 Months|||units on a scale||Standard Deviation|Mean
695465|NCT01390038|Secondary|Device Parameters|"Devices will be assessed to determine percentage of participants that demonstrated the following after total shoulder arthroplasty:
Migration
Osteolysis
Subsidence"|24 months|||Percentage of participants|||Number
695466|NCT01390038|Secondary|Strength|Strength of a Specific shoulder motion as measured in pounds of force on a dynamometer machine supplied by Tornier|24 months|||Pounds||Standard Deviation|Mean
695467|NCT01390038|Secondary|Range of Motion|"Elevation in the scapula plane
Internal rotation with arm at the side
External rotation with arm at the side"|24 months|||Degrees||Standard Deviation|Mean
695468|NCT01390038|Secondary|Quality of Life|"Simple Shoulder Test
1 (worse) - 12 (best)"|24 months|||units on a scale||Standard Deviation|Mean
695469|NCT01390038|Primary|Device Success Rate|"A subject is a Patient Success at 24-months if:
There is NO continuous radiolucent line around the prosthesis; and
The adjusted Constant Score is > 85 (successful outcome); and
They did not have revision surgery; and
They did not have a system-related serious adverse event."|24 months|||participants|||Number
695470|NCT01389973|Secondary|Part 1: Percent Change From Baseline in Alanine Aminotransferase, Aspartate Aminotransferase, and Bilirubin Concentration at Week 28||Baseline and Week 28|"Efficacy analysis set included all participants who received at least 1 administration of ustekinumab (full or partial). N (number of participants analyzed) signifies participants who were evalubale for this outcome measure. n signifies participants who were evalubale for each specified category."||percent change||Standard Deviation|Mean
695471|NCT01389973|Secondary|Part 1: Percent Change From Baseline in ALP Concentration at Week 28||Baseline and Week 28|Efficacy analysis set included all participants who received at least 1 administration of ustekinumab (full or partial).||percent change||Standard Deviation|Mean
695472|NCT01389973|Secondary|Part 1: Number of Participants With ALP Remission at Week 28|ALP remission is defined as either normalization of ALP (for participants with baseline ALP between 1.67*and 2.8* upper limit of normal [ULN] or an ALP less than [˂]1.67*ULN [for participants with baseline ALP greater than {˃} 2.8* ULN]). ALP levels above 1.67* ULN level were associated with an increased rate of disease progression.|Week 28|Efficacy analysis set included all participants who received at least 1 administration of ustekinumab (full or partial).||participants|||Number
695473|NCT01389973|Secondary|Part 1: Number of Participants With ALP Response at Week 28||Week 28|Efficacy analysis set included all participants who received at least 1 administration of ustekinumab (full or partial).||participants|||Number
695474|NCT01389973|Primary|Part 1: Number of Participants With Alkaline Phosphatase (ALP) Response at Week 12|The ALP response was defined as a greater than 40 percent (%) decrease from Baseline in ALP concentration at Week 12.|Week 12|Efficacy analysis set included all participants who received at least 1 administration of ustekinumab (full or partial).||participants|||Number
695475|NCT01389882|Secondary|Capillary Blood HCO3|Capillary blood HCO3 checked immediately after the 4-hour respiratory support with each ventilator mode|four hours|"The analysis was per protocol. 19 patients who had completed the study was used for the analysis."||mmol/L||Standard Deviation|Mean
695476|NCT01389882|Secondary|Capillary Blood pO2|Capillary blood pO2 checked immediately after the 4-hour respiratory support with each ventilator mode|four hours|"The analysis was per protocol. 19 patients who had completed the study was used for the analysis."||mmHg||Standard Deviation|Mean
695477|NCT01389882|Secondary|Capillary Blood pCO2|Capillary blood pCO2 checked immediately after the 4-hour respiratory support with each ventilator mode|four hours|"The analysis was per protocol. 19 patients who had completed the study was used for the analysis."||mmHg||Standard Deviation|Mean
703394|NCT00094900|Secondary|Mean Change in Ferritin|Ferritin level change from baseline to 3 months|3 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||mcg/L||Standard Error|Mean
695487|NCT01389856|Secondary|Accumulation Index (AI) for Bosentan|Concentrations were measured directly in dried blood spot samples scheduled to be taken immediately prior to first study drug administration and at 0.5, 1, 2, 3, 7.5 and 12 hours post-dose on Days 1 and 5. Pharmacokinetic parameters were determined on the basis of scheduled blood sampling time points using non-compartmental analysis. Actual blood sampling times were used only if there was a deviation of more than 5% from the scheduled times. AI was calculated as the ratio AUCtau /AUC0-12 for the subjects having PK samples collected on Day 1 and Day 5 and with AUC0-12 > 0 ng.h/mL.|5 days|PK analysis set. This analysis set comprised all patients included in the all-treated set who were able to provide at least 5 of the 7 blood samples requested for at least one evaluable profile of PK assessment and who did not violate the protocol in a way that might affect the evaluation of the PK endpoints.||accumulation index||95% Confidence Interval|Geometric Mean
695488|NCT01389856|Secondary|Area Under the Concentration-time Curve Over a Period of 24 h (Dose-corrected to 2 mg/kg) on Day 5 (AUC0-24C Day 5) for Bosentan and Its Metabolites, Ro 47-8634, Ro 48-5033, and Ro 64-1056|Concentrations were measured directly in dried blood spot samples scheduled to be taken immediately prior to study drug administration and at 0.5, 1, 2, 3, 7.5, and 12 hours post-dose on Day 5. Pharmacokinetic parameters were determined on the basis of scheduled blood sampling time points using non-compartmental analysis. Actual blood sampling times were used only if there was a deviation of more than 5% from the scheduled times. AUC0-24C Day 5 was calculated as a multiple of AUCtau, (2 × AUCtau for 2 times daily dosing) corrected to 2 mg/kg.|24 hours|PK analysis set. This analysis set comprised all patients included in the all-treated set who were able to provide at least 5 of the 7 blood samples requested for at least one evaluable profile of PK assessment and who did not violate the protocol in a way that might affect the evaluation of the PK endpoints.||h*ng/mL||95% Confidence Interval|Geometric Mean
695489|NCT01389856|Secondary|Area Under the Concentration-time Curve Over a Period of 24 h (Dose-corrected to 2 mg/kg) on Day 1 (AUC0-24C Day 1) for Bosentan and Its Metabolites, Ro 47-8634, Ro 48-5033, and Ro 64-1056|Concentrations were measured directly in dried blood spot samples scheduled to be taken immediately prior to first study drug administration and at 0.5, 1, 2, 3, 7.5 and 12 hours post-dose on Day 1. Pharmacokinetic parameters were determined on the basis of scheduled blood sampling time points using non-compartmental analysis. Actual blood sampling times were used only if there was a deviation of more than 5% from the scheduled times. AUC0-24C Day 1 was calculated as a multiple of AUC0-12, (2 × AUC0-12 for 2 times daily dosing) corrected to 2 mg/kg.|24 hours|PK analysis set. This analysis set comprised all patients included in the all-treated set who were able to provide at least 5 of the 7 blood samples requested for at least one evaluable profile of PK assessment and who did not violate the protocol in a way that might affect the evaluation of the PK endpoints.||h*ng/mL||95% Confidence Interval|Geometric Mean
695490|NCT01389856|Secondary|Area Under the Concentration-time Curve Over a Dosing Interval at Steady State on Day 5 (AUCtau) for Bosentan and Its Metabolites, Ro 47-8634, Ro 48-5033, and Ro 64-1056|Concentrations were measured directly in dried blood spot samples scheduled to be taken immediately prior to study drug administration and at 0.5, 1, 2, 3, 7.5, and 12 hours post-dose on Day 5. Pharmacokinetic parameters were determined on the basis of scheduled blood sampling time points using non-compartmental analysis. Actual blood sampling times were used only if there was a deviation of more than 5% from the scheduled times. AUCtau Day 5 was calculated according to the trapezoidal rule using the measured concentration-time values above the limit of quantification.|5 days|PK analysis set. This analysis set comprised all patients included in the all-treated set who were able to provide at least 5 of the 7 blood samples requested for at least one evaluable profile of PK assessment and who did not violate the protocol in a way that might affect the evaluation of the PK endpoints.||h*ng/mL||95% Confidence Interval|Geometric Mean
695491|NCT01389856|Secondary|Area Under the Concentration-time Curve Over a Period of 12 h (AUC0-12 Day 1)) for Bosentan and Its Metabolites, Ro 47-8634, Ro 48-5033, and Ro 64-1056 on Day 1|Concentrations were measured directly in dried blood spot samples scheduled to be taken immediately prior to first study drug administration and at 0.5, 1, 2, 3, 7.5 and 12 hours post-dose on Day 1. Pharmacokinetic parameters were determined on the basis of scheduled blood sampling time points using non-compartmental analysis. Actual blood sampling times were used only if there was a deviation of more than 5% from the scheduled times. AUC0-12 Day 1 was calculated according to the trapezoidal rule using the measured concentration-time values above the limit of quantification.|12 hours|PK analysis set. This analysis set comprised all patients included in the all-treated set who were able to provide at least 5 of the 7 blood samples requested for at least one evaluable profile of PK assessment and who did not violate the protocol in a way that might affect the evaluation of the PK endpoints.||h*ng/mL||95% Confidence Interval|Geometric Mean
695492|NCT01389856|Secondary|Tmax for Ro 64-1056 on Day 5|Concentrations were measured directly in dried blood spot samples scheduled to be taken immediately prior to study drug administration and at 0.5, 1, 2, 3, 7.5, and 12 hours post-dose on Day 5. Tmax was obtained directly from the measured concentrations.|12 hours|PK analysis set. This analysis set comprised all patients included in the all-treated set who were able to provide at least 5 of the 7 blood samples requested for at least one evaluable profile of PK assessment and who did not violate the protocol in a way that might affect the evaluation of the PK endpoints.||hours||Full Range|Median
695493|NCT01389856|Secondary|Tmax for Ro 48-5033 on Day 5|Concentrations were measured directly in dried blood spot samples scheduled to be taken immediately prior to study drug administration and at 0.5, 1, 2, 3, 7.5, and 12 hours post-dose on Day 5. Tmax was obtained directly from the measured concentrations.|12 hours|PK analysis set. This analysis set comprised all patients included in the all-treated set who were able to provide at least 5 of the 7 blood samples requested for at least one evaluable profile of PK assessment and who did not violate the protocol in a way that might affect the evaluation of the PK endpoints.||hours||Full Range|Median
695494|NCT01389856|Secondary|Tmax for Ro 47-8634 on Day 5|Concentrations were measured directly in dried blood spot samples scheduled to be taken immediately prior to study drug administration and at 0.5, 1, 2, 3, 7.5, and 12 hours post-dose on Day 5. Tmax was obtained directly from the measured concentrations.|12 hours|PK analysis set. This analysis set comprised all patients included in the all-treated set who were able to provide at least 5 of the 7 blood samples requested for at least one evaluable profile of PK assessment and who did not violate the protocol in a way that might affect the evaluation of the PK endpoints.||hours||Full Range|Median
706183|NCT00105482|Secondary|Cigarettes Smoked Per Day.|Average number of cigarettes smoked per day at 26 weeks.|26 weeks|Patients were analyzed per protocol.||number of cigarettes||Standard Deviation|Mean
695495|NCT01389856|Secondary|Tmax for Bosentan on Day 5|Concentrations were measured directly in dried blood spot samples scheduled to be taken immediately prior to study drug administration and at 0.5, 1, 2, 3, 7.5, and 12 hours post-dose on Day 5. Tmax was obtained directly from the measured concentrations.|12 hours|PK analysis set. This analysis set comprised all patients included in the all-treated set who were able to provide at least 5 of the 7 blood samples requested for at least one evaluable profile of PK assessment and who did not violate the protocol in a way that might affect the evaluation of the PK endpoints.||hours||Full Range|Median
695496|NCT01389856|Secondary|Tmax for Ro 64-1056 on Day 1|Concentrations were measured directly in dried blood spot samples scheduled to be taken immediately prior to first study drug administration and at 0.5, 1, 2, 3, 7.5 and 12 hours post-dose on Day 1. Tmax was obtained directly from the measured concentrations.|up to 12 hours|PK analysis set. This analysis set comprised all patients included in the all-treated set who were able to provide at least 5 of the 7 blood samples requested for at least one evaluable profile of PK assessment and who did not violate the protocol in a way that might affect the evaluation of the PK endpoints.||hours||Full Range|Median
695497|NCT01389856|Secondary|Tmax for Ro 48-5033 on Day 1|Concentrations were measured directly in dried blood spot samples scheduled to be taken immediately prior to first study drug administration and at 0.5, 1, 2, 3, 7.5 and 12 hours post-dose on Day 1. Tmax was obtained directly from the measured concentrations.|up to 12 hours|PK analysis set. This analysis set comprised all patients included in the all-treated set who were able to provide at least 5 of the 7 blood samples requested for at least one evaluable profile of PK assessment and who did not violate the protocol in a way that might affect the evaluation of the PK endpoints.||hours||Full Range|Median
695498|NCT01389856|Secondary|Tmax for Ro 47-8634 on Day 1|Concentrations were measured directly in dried blood spot samples scheduled to be taken immediately prior to first study drug administration and at 0.5, 1, 2, 3, 7.5 and 12 hours post-dose on Day 1. Tmax was obtained directly from the measured concentrations.|up to 12 hours|PK analysis set. This analysis set comprised all patients included in the all-treated set who were able to provide at least 5 of the 7 blood samples requested for at least one evaluable profile of PK assessment and who did not violate the protocol in a way that might affect the evaluation of the PK endpoints.||hours||Full Range|Median
695499|NCT01389856|Secondary|Time to Maximum Whole Blood Concentration (Tmax) for Bosentan on Day 1|Concentrations were measured directly in dried blood spot samples scheduled to be taken immediately prior to first study drug administration and at 0.5, 1, 2, 3, 7.5 and 12 hours post-dose on Day 1. Tmax was obtained directly from the measured concentrations.|up to 12 hours|PK analysis set. This analysis set comprised all patients included in the all-treated set who were able to provide at least 5 of the 7 blood samples requested for at least one evaluable profile of PK assessment and who did not violate the protocol in a way that might affect the evaluation of the PK endpoints.||hours||Full Range|Median
695500|NCT01389856|Secondary|Cmax for Bosentan and Its Metabolites, Ro 47-8634, Ro 48-5033, and Ro 64-1056 on Day 5|Concentrations were measured directly in dried blood spot samples scheduled to be taken immediately prior to study drug administration and at 0.5, 1, 2, 3, 7.5, and 12 hours post-dose on Day 5. Cmax obtained directly from the measured concentrations . Cmax was corrected to a dose of 2 mg/kg bosentan (Cmaxc). The target dose was 2 mg/kg. However, as the smallest dose unit was 8 mg (quarter of a tablet), it was not possible to achieve the exact target dose in all patients. Therefore, Cmax was divided by the actual dose (in mg/kg) and multiplied by 2 mg/kg.|12 hours|PK analysis set. This analysis set comprised all patients included in the all-treated set who were able to provide at least 5 of the 7 blood samples requested for at least one evaluable profile of PK assessment and who did not violate the protocol in a way that might affect the evaluation of the PK endpoints.||ng/mL||95% Confidence Interval|Geometric Mean
695501|NCT01389856|Secondary|Maximum Whole Blood Concentration (Cmax) for Bosentan and Its Metabolites, Ro 47-8634, Ro 48-5033, and Ro 64-1056 on Day 1|Concentrations were measured directly in dried blood spot samples scheduled to be taken immediately prior to first study drug administration and at 0.5, 1, 2, 3, 7.5 and 12 hours post-dose on Day 1. Cmax was obtained directly from the measured concentrations. Cmax was corrected to a dose of 2 mg/kg bosentan (Cmaxc). The target dose was 2 mg/kg. However, as the smallest dose unit was 8 mg (quarter of a tablet), it was not possible to achieve the exact target dose in all patients. Therefore, Cmax was divided by the actual dose (in mg/kg) and multiplied by 2 mg/kg.|up to 12 hours|Pharmacokinetic (PK) analysis set. This analysis set comprised all patients included in the all-treated set who were able to provide at least 5 of the 7 blood samples requested for at least one evaluable profile of PK assessment and who did not violate the protocol in a way that might affect the evaluation of the PK endpoints.||ng/mL||95% Confidence Interval|Geometric Mean
695502|NCT01389856|Secondary|Change in Fraction of Inspired Oxygen (FiO2) From Baseline to 72 Hours Following Study Drug Administration|FiO2 was determined according to each study centers’ standard procedure at baseline and 72 h after the first study drug administration|72 hours|Randomized and treated patients with available data||percentage of oxygen||95% Confidence Interval|Median
695503|NCT01389856|Secondary|Change in Post-ductal Peripheral Oxygen Saturation (SpO2) From Baseline to 72 Hours Following Study Drug Administration|Simultaneous pre- (right hand) and post-ductal (lower extremities) SpO2 were measured using pulse oximetry device at baseline and 72 h after the first study drug administration|72 hours|Randomized and treated patients with available data||percentage saturation||95% Confidence Interval|Median
695504|NCT01389856|Secondary|Change in Pre-ductal Peripheral Oxygen Saturation (SpO2) From Baseline to 72 Hours Following Study Drug Administration|Simultaneous pre- (right hand) and post-ductal (lower extremities) SpO2 were measured using pulse oximetry device at baseline and 72 h after the first study drug administration|72 hours|Randomized and treated patients with available data||percentage saturation||95% Confidence Interval|Median
695505|NCT01389856|Secondary|Change in Partial Pressure of Carbon Dioxide (PaCO2) in Arterial Blood From Baseline to 72 Hours Following Study Drug Administration|PaCO2 was determined in arterial blood samples at baseline and 72 h after the first study drug administration|72 hours|Randomized and treated patients with available data||mm Hg||95% Confidence Interval|Median
695506|NCT01389856|Secondary|Change in Partial Pressure of Oxygen (PaO2) in Arterial Blood From Baseline to 72 Hours Following Study Drug Administration|PaO2 was determined in arterial blood samples at baseline and 72 h after the first study drug administration|72 hours|Randomized and treated patients with available data||mm Hg||95% Confidence Interval|Median
695507|NCT01389856|Secondary|Change in Arterial Blood Oxygen Saturation (SaO2) From Baseline to 72 Hours Following Study Drug Administration|SaO2 was determined in arterial blood samples at baseline and 72 h after the first study drug administration|72 hours|Randomized and treated patients with available data||percentage saturation||95% Confidence Interval|Median
695508|NCT01389856|Secondary|Change in Arterial Blood Gas (ABG) pH From Baseline to 72 Hours Following Study Drug Administration|pH was determined in arterial blood samples at baseline and 72 h after the first study drug administration|72 hours|Randomized and treated patients with available data||pH||95% Confidence Interval|Median
695509|NCT01389856|Secondary|Change in Oxygenation Index (OI) From Baseline to 72 Hours Following Study Drug Administration|The change in OI from baseline following study drug administration was determined. OI was calculated as the mean airway pressure multiplied by the fraction of inspired oxygen (expressed in %), and the product was divided by the partial pressure of oxygen in arterial blood.|72 hours|Randomized and treated patients with available data||oxygenation index||95% Confidence Interval|Median
695510|NCT01389856|Secondary|Change in Oxygenation Index (OI) From Baseline to 48 Hours Following Study Drug Administration|The change in OI from baseline following study drug administration was determined. OI was calculated as the mean airway pressure multiplied by the fraction of inspired oxygen (expressed in %), and the product was divided by the partial pressure of oxygen in arterial blood.|48 hours|Randomized and treated patients with available data||oxygenation index||95% Confidence Interval|Median
695511|NCT01389856|Secondary|Change in Oxygenation Index (OI) From Baseline to 24 Hours Following Study Drug Administration|The change in OI from baseline following study drug administration was determined. OI was calculated as the mean airway pressure multiplied by the fraction of inspired oxygen (expressed in %), and the product was divided by the partial pressure of oxygen in arterial blood.|24 hours|Randomized and treated patients||oxygenation index||95% Confidence Interval|Median
695512|NCT01389856|Secondary|Change in Oxygenation Index (OI) From Baseline to 12 Hours Following Study Drug Administration|The change in OI from baseline following study drug administration was determined. OI was calculated as the mean airway pressure multiplied by the fraction of inspired oxygen (expressed in %), and the product was divided by the partial pressure of oxygen in arterial blood.|12 hours|Randomized and treated patients||oxygenation index||95% Confidence Interval|Median
695513|NCT01389856|Secondary|Change in Oxygenation Index (OI) From Baseline to 5 Hours Following Study Drug Administration|The change in OI from baseline following study drug administration was determined. OI was calculated as the mean airway pressure multiplied by the fraction of inspired oxygen (expressed in %), and the product was divided by the partial pressure of oxygen in arterial blood.|5 hours|Randomized and treated patients||oxygenation index||95% Confidence Interval|Median
695514|NCT01389856|Secondary|Change in Oxygenation Index (OI) From Baseline to 3 Hours Following Study Drug Administration|The change in OI from baseline following study drug administration was determined. OI was calculated as the mean airway pressure multiplied by the fraction of inspired oxygen (expressed in %), and the product was divided by the partial pressure of oxygen in arterial blood.|3 hours|Randomized and treated patients||oxygenation index||95% Confidence Interval|Median
695515|NCT01389856|Secondary|Percentage of Patients With Pulmonary Hypertension (PH) at End of Treatment|"The presence of PH was assessed by echocardiography. PH was reported as ‘present’ if at least one of the following criteria was met:
Shunt through ductus arteriosus was either ‘predominant right to left’ or ‘bidirectional’
Shunt through foramen ovale was either ‘predominant right to left’ or ‘bidirectional’
Marked right ventricular dilation was ticked ‘present’
Paradoxical shift of intraventricular septum was ticked ‘present’
Right ventricular systolic pressure (mmHg) was > 2/3 of the reported systemic blood pressure"|From baseline to up to 14 days|Randomized and treated patients||percentage of participants|||Number
695516|NCT01389856|Secondary|Percentage of Patients Requiring Re-initiation of iNO Therapy|Re-initiation of iNO therapy following weaning from iNO therapy|From baseline to up to 21 days|Randomized and treated patients||percentage of participants|||Number
695517|NCT01389856|Primary|Time to Complete Weaning From Mechanical Ventilation|Calculated from the time from first study drug administration to complete weaning from mechanical ventilation|From baseline to up to 21 days|Randomized and treated patients||days||95% Confidence Interval|Median
695518|NCT01389856|Primary|Time to Complete Weaning From iNO|Calculated from the time from first study drug administration to complete weaning from iNO. Weaning from iNO was considered complete if there was no requirement for the re-initiation of iNO within 24 h after stopping|From baseline to up to 21 days|Randomized and treated patients||days||95% Confidence Interval|Median
695519|NCT01389856|Primary|Percentage of Patients With Treatment Failure|Treatment failure was defined as the need for extra corporeal membrane oxygenation or initiation of alternative pulmonary vasodilator treatment|From baseline to up to 21 days|Randomized and treated patients||percentage of participants|||Number
695520|NCT01389817|Primary|N95 Peak Via pERG and fERG -PhNR|The primary comparison will be a paired comparison of pre- and post-treatment retinal ganglion cell N95 pattern electroretinogram (pERG) peaks and fERG - Photopic Negative Response (PhNR). Pairing will be done between a subject's treatment and control eye.|12 months|All participants were withdrawn before any data could be obtained.|||||
695521|NCT01389596|Other Pre-specified|Number of Participants With Clinically Significant Change From Baseline in Physical Examinations at Week 13|Physical examinations evaluated the following body systems/organs: general appearance; dermatological; head and eyes; ears, nose, mouth, and throat; pulmonary; cardiovascular; abdominal; genitourinary (optional); lymphatic; musculoskeletal/extremities; and neurological. Clinical significance was determined by the investigator.|Baseline (from 8 weeks prior to Day 1 of treatment) up to Week 13|Safety population included all randomized participants who took at least 1 dose of the study drug.||participants|||Number
695533|NCT01389596|Other Pre-specified|Number of Adverse Events by Severity|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs were classified according to the severity in 3 categories a) mild: AEs does not interfere with participant’s usual function b) moderate: AEs interferes to some extent with participant’s usual function c) severe: AEs interferes significantly with participant’s usual function.|Day 1 up to 7 days after last dose of study drug (up to 13 weeks)|Safety population included all randomized participants who took at least 1 dose of the study drug.||events|||Number
707921|NCT00128180|Secondary|Duration of Hospital Stay in Days|Days|6 months|Per protocol, efficacy analysis was limited to participants with confirmed hantairus infection.||days||Standard Deviation|Mean
695522|NCT01389596|Other Pre-specified|Number of Participants With Electrocardiogram (ECG) Abnormalities|Criteria for abnormalities in ECG findings: 1) Time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization (QRS complex): >=140 milliseconds (msec); 2) The interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization (PR interval): >=200 msec; 3) Time from ECG Q wave to the end of the T wave corresponding to electrical systole corrected for heart rate using Fridericia’s formula (QTCF interval): absolute value 450 to <480 msec, 480 to <500 msec, >=500 msec; 4) Maximum QT interval: >=500 msec; 5) Maximum QTCB interval (Bazett’s correction): 450 to< 480 msec, 480 to <500 msec, >=500 msec. Only those categories of ECG abnormalities in which participants were found abnormal, were reported in this outcome measure.|Baseline (from 8 weeks prior to Day 1 of treatment) up to Week 13|"Safety population included all randomized participants who took at least 1 dose of the study drug. Here, N signifies number of participants who were evaluable for this outcome measure."||participants|||Number
695523|NCT01389596|Other Pre-specified|Number of Participants With Clinically Significant Change From Baseline in Neurological Examinations|Neurological examinations included: level of consciousness, mental status, cranial nerve assessment, muscle strength and tone, reflexes, pin prick and vibratory sensation (the latter using a 128-Hertz tuning fork), coordination and gait. Clinical significance was based on investigator's discretion.|Baseline (from 8 weeks prior to Day 1 of treatment) up to Week 13|Safety population included all randomized participants who took at least 1 dose of the study drug.||participants|||Number
695524|NCT01389596|Other Pre-specified|Number of Participants With Vital Signs Abnormalities|Criteria for abnormalities in vital signs included: sitting systolic blood pressure (SBP) values: maximum increase and decrease of >=30 millimeter of mercury (mmHg) from baseline; sitting diastolic blood pressure (DBP) value: maximum increase and decrease of >=20 mmHg from baseline.|Baseline (from 8 weeks prior to Day 1 of treatment) up to Week 13|"Safety population included all randomized participants who took at least 1 dose of the study drug. Here, N signifies number of participants who were evaluable for this outcome measure."||participants|||Number
695525|NCT01389596|Other Pre-specified|Number of Participants With Clinically Significant Laboratory Abnormalities|Criteria for abnormality: hematology (hemoglobin, hematocrit, red blood cells count:<]0.8*lower limit of normal [LLN],platelets:<0.5*LLN/greater than [>]1.75*upper limit of normal [ULN],leukocytes:<0.6*LLN or>1.5*ULN, lymphocytes, total neutrophils:<0.8*LLN or >1.2*ULN, basophils, eosinophil, monocytes:>1.2*ULN); Liver Function(aspartate aminotransferase ,alanine aminotransferase, alkaline phosphatase, Gamma glutamyl transferase:>0.3*ULN, total protein, albumin:<0.8*LLN or >1.2*ULN); bilirubin:>1.5*ULN; renal function(blood urea nitrogen, creatinine:>1.3*ULN); Electrolytes(sodium:<0.95*LLN or>1.05*ULN, potassium, chloride, calcium, bicarbonate:<0.9*LLN or >1.1*ULN); Lipids(cholesterol, triglycerides >1.3*ULN); creatine kinase:>2.0*ULN; glucose fasting:<0.6*LLN or >1.5*ULN, urine white blood corpuscles and RBC:>= 20/High Power Field [HPF];urine casts: >1/Low Power Field(LPF);urine bacteria:>20/HPF. Hormones (tetraiodothyronine and thyroid stimulating hormone:<0.8*LLN or >1.2*ULN).|Baseline (from 8 weeks prior to Day 1 of treatment) up to Week 13|"Safety population included all randomized participants who took at least 1 dose of the study drug. Here, N signifies number of participants who were evaluable for this outcome measure."||participants|||Number
695526|NCT01389596|Other Pre-specified|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Week 12: Paediatric Identification (Go-No Go: Attention) Tasks|CogState battery: computerized test battery used to assess cognitive domains through cognition tests/tasks. The test battery was presented on computer with external response buttons. Paediatric identification task: a measure of choice reaction time and valid assessment of visual attention. In this task, a playing card turning face up was presented in center of the computer screen. As soon as this happened, participant had to decide whether color of card was black or not. If color was black, participants was to press “Yes” response key, otherwise “no”. There was no minimum/maximum scores since it was a time-based assessment. The software measured speed of accurate responses (correct identification of color) to each event. In this outcome measure, speed of performance of participants to correctly identify the color (calculated as mean of the logarithmic base 10 transformed reaction times) for correct responses was reported. Lower scores indicated better performance.|Baseline (pre-dose at Day 1), Week 12|"Safety population included all randomized participants who took at least 1 dose of the study drug.Here, N signifies number of participants who were evaluable for this measure and ‘n’ signifies number of participants evaluated for specific categories for each arm respectively."||log10 milliseconds||Standard Deviation|Mean
695527|NCT01389596|Other Pre-specified|Change From Baseline in Cognitive Test Battery (CogState Battery) Scores at Week 12: Detection Task|CogState battery:computerized test battery used to assess cognitive domains through cognition tests/tasks. The test battery was presented on computer with external response buttons. In this study, Cogstate battery consisted of 2 tasks which measured psychomotor function (detection task) and attention (paediatric identification task). Detection task was a measure of simple reaction time and provided a valid assessment of psychomotor function in participants. In this task, a playing card turning face up was presented in the center of the computer screen. As soon as this happened, the participant was to press the 'Yes' response key. There was no minimum or maximum scores since it was a time-based assessment. The software measured the speed of accurate responses to each event. In this outcome measure, speed of performance of participants (calculated as mean of the logarithmic base 10 transformed reaction times) for correct responses was reported. Lower scores indicated better performance.|Baseline (pre-dose at Day 1), Week 12|"Safety population included all randomized participants who took at least 1 dose of the study drug.Here, N signifies number of participants who were evaluable for this measure and ‘n’ signifies number of participants evaluated for specific categories for each arm respectively."||log10 milliseconds||Standard Deviation|Mean
695554|NCT01389102|Primary|Mean Change in the Number of Moderate to Severe Vasomotor Symptoms Per Day|"Patients completed a daily diary to record the number of mild, moderate and number of moderate or severe vasomotor symptoms [hot flushes and sweating] experienced each day.
Mild, moderate and severe hot flushes and sweating were defined as follows:
Mild = sensation of heat without sweating Moderate = sensation of heat with sweating, ability to continue activity Severe = sensation of heat with sweating, causing discontinuation of activity"|baseline to week 12|||Vasomotor symptoms per day||Standard Deviation|Mean
695555|NCT01389076|Secondary|Number of Participants That Experienced SAEs During Treatment.||Up to week 13|||participants|||Number
695528|NCT01389596|Other Pre-specified|Child Behaviour Checklist (CBCL): Total Problem Subscale Score in Participants Less Than 6 Years of Age|CBCL assessed suicidal behavior in children below 6 years. It is 100-item questionnaire completed by parent/legal guardian, based on participant’s behavior in past 2 months. All 100 items rated on 3-point scale: 0=not true for that child; 1=sometimes true; 2=very/often true. Total CBCL score ranges from 0 (not true) to 200 (very/often true). Higher scores=higher levels of problematic behaviors or dysfunction. Scores from all items were used to calculate 3 subscale scores: Withdrawn subscale scores, Internalizing problems subscale scores and total problem subscale scores. All subscale scores reported scaled to T Scores. Higher scores for each CBCL subscales indicated higher levels of problematic behaviors or dysfunction. In this study, a cut-off of >=68 on the T-scores was used for all 3 subscales. If a participant T Score was >=68 in any of the sub-scales, the participant was referred for Mental Health Risk Assessment that included assessment of participant continuation to the study|Week -8 (8 weeks prior to Day 1 of treatment), Week -4 (4 weeks prior to Day 1 of treatment), Day 1 (Week 0), Week 1, 2, 3, 6, 9, 12, end of study visit (Week 13)|"Safety population included all randomized participants who took at least 1 dose of the study drug.Here, N signifies number of participants who were evaluable for this measure and ‘n’ signifies number of participants evaluated for specific categories for each arm respectively."||T scores||Standard Deviation|Mean
695529|NCT01389596|Other Pre-specified|Child Behaviour Checklist (CBCL): Withdrawn Subscale Score in Participants Less Than 6 Years of Age|CBCL assessed suicidal behavior in children below 6 years. It is 100-item questionnaire completed by parent/legal guardian, based on participant’s behavior in past 2 months. All 100 items rated on 3-point scale: 0=not true for that child; 1=sometimes true; 2=very/often true. Total CBCL score ranges from 0 (not true) to 200 (very/often true). Higher scores=higher levels of problematic behaviors or dysfunction. Scores from all items were used to calculate 3 subscale scores: Withdrawn subscale scores, Internalizing problems subscale scores and total problem subscale scores. All subscale scores reported scaled to T Scores. Higher scores for each CBCL subscales indicated higher levels of problematic behaviors or dysfunction. In this study, a cut-off of >=68 on the T-scores was used for all 3 subscales. If a participant T Score was >=68 in any of the sub-scales, the participant was referred for Mental Health Risk Assessment that included assessment of participant continuation to the study|Week -8 (8 weeks prior to Day 1 of treatment), Week -4 (4 weeks prior to Day 1 of treatment), Day 1 (Week 0), Week 1, 2, 3, 6, 9, 12, end of study visit (Week 13)|"Safety population included all randomized participants who took at least 1 dose of the study drug.Here, N signifies number of participants who were evaluable for this measure and ‘n’ signifies number of participants evaluated for specific categories for each arm respectively."||T scores||Standard Deviation|Mean
695530|NCT01389596|Other Pre-specified|Child Behaviour Checklist (CBCL): Internalizing Subscale Score in Participants Less Than 6 Years of Age|CBCL assessed suicidal behavior in children below 6 years. It is 100-item questionnaire completed by parent/legal guardian, based on participant’s behavior in past 2 months. All 100 items rated on 3-point scale: 0=not true for that child; 1=sometimes true; 2=very/often true. Total CBCL score ranges from 0 (not true) to 200 (very/often true). Higher scores=higher levels of problematic behaviors or dysfunction. Scores from all items were used to calculate 3 subscale scores: Withdrawn subscale scores, Internalizing problems subscale scores and total problem subscale scores. All subscale scores reported scaled to T Scores. Higher scores for each CBCL subscales indicated higher levels of problematic behaviors or dysfunction. In this study, a cut-off of >=68 on the T-scores was used for all 3 subscales. If a participant T Score was >=68 in any of the sub-scales, the participant was referred for Mental Health Risk Assessment that included assessment of participant continuation to the study.|Week -8 (8 weeks prior to Day 1 of treatment), Week -4 (4 weeks prior to Day 1 of treatment), Day 1 (Week 0), Week 1, 2, 3, 6, 9, 12, end of study visit (Week 13)|"Safety population included all randomized participants who took at least 1 dose of the study drug.Here, N signifies number of participants who were evaluable for this measure and ‘n’ signifies number of participants evaluated for specific categories for each arm respectively."||T scores||Standard Deviation|Mean
695531|NCT01389596|Other Pre-specified|Number of Participants (6-16 Years of Age) With Positive Response to Columbia Suicide-Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories During Post Baseline Time Period|C-SSRS (mapped to C-CASA):participant-rated questionnaire to assess suicidal ideation and suicidal behavior. For suicidal ideation and behaviour, data from C-SSRS was mapped to C-CASA codes 1, 2, 3, 4 and 7. C-SSRS assessed whether participant experienced the following: completed suicide (C-CASA code 1); suicide attempt (response of “Yes” on “actual attempt”) (C-CASA code 2); preparatory acts toward imminent suicidal behavior (ISB) (“Yes” on “preparatory acts or behavior”)(C-CASA code 3); suicidal ideation (“Yes” on “wish to be dead”, “non-specific active suicidal thoughts”, “active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent) (C-CASA code 4); any self-injurious behavior with no suicidal intent (C-CASA code 7). Number of participants with positive response (response of “yes”) to C-SSRS (mapped to C-CASA categories 1, 2, 3, 4 and 7) during post baseline time period (Day 1 up to Week 13) were reported|Day 1 up to Week 13|"Safety population included all randomized participants who took at least 1 dose of the study drug. Here, N signifies number of participants who were evaluable for this outcome measure."||participants|||Number
695532|NCT01389596|Other Pre-specified|Number of Participants (6-16 Years of Age) With Positive Response to Columbia Suicide-Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories At Baseline|The C-SSRS (mapped to C-CASA) is a participant-rated questionnaire to assess suicidal ideation and suicidal behavior. For suicidal ideation and behaviour, data from C-SSRS was mapped to C-CASA codes 1, 2, 3, 4 and 7. C-SSRS assessed whether participant experienced the following: completed suicide (C-CASA code 1); suicide attempt (response of “Yes” on “actual attempt”) (C-CASA code 2); preparatory acts toward imminent suicidal behavior (ISB) (“Yes” on “preparatory acts or behavior”)(C-CASA code 3); suicidal ideation (“Yes” on “wish to be dead”, “non-specific active suicidal thoughts”, “active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent) (C-CASA code 4); any self-injurious behavior with no suicidal intent (C-CASA code 7). In this outcome, number of participants with positive response (response of “yes”) to C-SSRS (mapped to C-CASA categories 2, 3, 4 and 7) at baseline were reported.|Baseline (4 week prior to Day 1 of treatment)|"Safety population included all randomized participants who took at least 1 dose of the study drug. Here, N signifies number of participants who were evaluable for this outcome measure."||participants|||Number
695534|NCT01389596|Other Pre-specified|Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)|Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 7 days after last dose of study drug (up to 13 weeks) that were absent before treatment or that worsened relative to pre-treatment state. Relatedness to drug was assessed by the investigator. AEs included both serious and non-serious adverse events.|Day 1 up to 7 days after last dose of study drug (up to 13 weeks)|Safety population included all randomized participants who took at least 1 dose of the study drug.||participants|||Number
695535|NCT01389596|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 7 days after last dose of study drug (up to 13 weeks) that were absent before treatment or that worsened relative to pre- treatment state. AEs included both serious and non-serious adverse events.|Day 1 up to 7 days after last dose of study drug (up to 13 weeks)|Safety population included all randomized participants who took at least 1 dose of the study drug.||participants|||Number
695536|NCT01389596|Secondary|Percentage of Participants With at Least 50 Percent (%) or Greater Reduction From Baseline in 28-day Seizure Rate During the 12 Week Treatment Phase|Percentage of participants with 50 percent (%) or greater reduction from baseline in 28-day seizure rate during the 12 week treatment phase were reported. 28-day seizure rate for all partial onset seizures = ([number of seizures in the treatment phase] divided by [number of days in treatment phase minus {–} number of missing diary days in treatment phase])*28.|Day 1 up to Week 12|ITT population included all randomized participants who received at least 1 dose of study drug during the double-blind treatment phase and had a baseline and at least 1 follow-up efficacy assessment.||percentage of participants|||Number
695537|NCT01389596|Primary|Log-Transformed 28-Day Seizure Rate For All Partial Onset Seizures During 12-Week Treatment Phase|"All partial onset seizures experienced during treatment phase were recorded by the participants or their parents/legal guardian in a daily seizure diary. 28-day seizure rate for all partial onset seizures = ([number of seizures in the treatment phase] divided by [number of days in treatment phase minus {–} number of missing diary days in treatment phase])*28. For log-transformation, the quantity 1 was added to the 28-day seizure rate for all participants to account for any possible 0 seizure incidence. This resulted in final calculation as: log transformed (28-day seizure rate +1)."|Day 1 up to Week 12|"ITT population included all randomized participants who received at least 1 dose of study drug during the double-blind treatment phase and had a baseline and at least 1 follow-up efficacy assessment. Here, Number of Participants Analyzed (N) signifies number of participants who were evaluable for this outcome measure."||Seizures per 28 days||Standard Error|Least Squares Mean
695538|NCT01389596|Primary|Log-Transformed 28-Day Seizure Rate For All Partial Onset Seizures During Baseline Phase|"All partial onset seizures experienced during baseline phase were recorded by the participants or their parents/legal guardian, in a daily seizure diary. 28-day seizure rate for all partial onset seizures = ([number of seizures in the baseline phase] divided by [number of days in baseline phase minus {–} number of missing diary days in baseline phase])*28. For log-transformation, the quantity 1 was added to the 28-day seizure rate for all participants to account for any possible 0 seizure incidence. This resulted in final calculation as: log transformed (28-day seizure rate +1)."|Baseline phase (up to 8 weeks prior to treatment phase [Day 1])|Intent-to-treat (ITT) population included all randomized participants who received at least 1 dose of study drug during the double-blind treatment phase and had a baseline and at least 1 follow-up efficacy assessment.||Seizures per 28 days||Standard Deviation|Mean
695539|NCT01389323|Secondary|Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Who Died|An AE was defined as any new unfavorable symptom, sign, or disease or worsening of a pre-existing condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Treatment-related AE was defined as an AE that had certain, probable, possible, or unknown relationship to study drug. For analysis purpose, participants were assigned to following 4 race/ethnicity cohorts: Black/African American, White/Caucasian, Latino and Non-Latino. Some participants were represented in more than one race/ethnicity cohort.|From first dose to last dose plus 7 days (treatment period [TP]) through 48 weeks after the end of TP (follow-up period [FUP])|"All treated participants for TP and all follow-up participants for FUP. Here, n signifies the number of participants evaluable in their respective study periods."||participants|||Number
695540|NCT01389323|Secondary|Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Not Detected, at Specified Time Points|The limit of detection for HCV RNA levels was 10 IU/mL and the LLOQ was 25 IU/mL. For analysis purpose, participants were assigned to following 3 race/ethnicity cohorts: Black/African American, Latino, and White non-Latino. Some participants were represented in more than one race/ethnicity cohort.|Weeks 1, 2, 4, 6, 8, 12; both Weeks 4 and 12; end-of-treatment (up to 48 weeks), or post-treatment Weeks 12 and 24|All treated participants. Here, 'N' (number of participants analyzed) signifies number of participants evaluable at the specified time-points.||percentage of participants||95% Confidence Interval|Number
695556|NCT01389076|Secondary|Median Progression Free Survival (PFS) Time|The median time patients survived without progression.|2 Years|Due to the withdrawal of Bexxar by the manufacture and failure to find another supplier, the trial was abandoned and follow-up scans were not obtained. Therefore only survival is known. Progression information is not available.|||||
695557|NCT01389076|Secondary|The Percentage of Participants Alive at 2 Years|Overall survival was examined at 2 years|2 years|||percentage of participants|||Number
695541|NCT01389323|Secondary|Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Detected or Target Not Detected, at Specified Time Points|The limit of detection for HCV RNA levels was 10 IU/mL and the LLOQ was 25 IU/mL. Data for post-treatment Weeks 36 and 48 were based on participants who had achieved virologic response (defined as HCV RNA levels <LLOQ, target not detected) at both Weeks 4 and 12, and completed 24 weeks of study treatment. For analysis purpose, participants were assigned to following 3 race/ethnicity cohorts: Black/African American, Latino, and White non-Latino. Some participants were represented in more than one race/ethnicity cohort.|Weeks 1, 2, 4, 6, 8, 12; both Weeks 4 and 12; end-of-treatment (up to 48 weeks), or post-treatment Week 24|All treated participants. Here, 'N' (number of participants analyzed) signifies number of participants evaluable at the specified time-points.||percentage of participants||95% Confidence Interval|Number
695542|NCT01389323|Secondary|Percentage of Participants Achieving Sustained Virologic Response at Post-treatment Week 12 (SVR12) With rs12979860 Single Nucleotide Polymorphisms at Baseline in the Interleukin-28B Gene|SVR12 was defined as Hepatitis C Virus (HCV) RNA levels <lower limit of quantitation (LLOQ), (target detected or target not detected) at Post-treatment Week 12. The limit of detection for HCV RNA was 10 IU/mL and the LLOQ was 25 IU/mL. For analysis purpose, participants were assigned to following 3 race/ethnicity cohorts: Black/African American, Latino, and White non-Latino. Some participants were represented in more than one race/ethnicity cohort.|Post-treatment Week 12|All treated participants. Here, 'n' signifies the number of participants evaluable in the specified category.||percentage of participants||95% Confidence Interval|Number
695543|NCT01389323|Primary|Percentage of Participants Achieving Sustained Virologic Response at Post-treatment Week 12 (SVR12)|SVR12 was defined as Hepatitis C Virus (HCV) RNA levels <lower limit of quantitation (LLOQ), (target detected or target not detected) at Post-treatment Week 12. The limit of detection for HCV RNA was 10 IU/mL and the LLOQ was 25 IU/mL. For analysis purpose, participants were assigned to following 3 race/ethnicity cohorts: Black/African American, Latino, and White non-Latino. Some participants were represented in more than one race/ethnicity cohort.|Post-treatment Week 12|All treated participants. Modified intent-to-treat analysis (participants meeting the response criteria / all treated participants) was performed for Black/African American and Latino cohorts.||percentage of participants||95% Confidence Interval|Number
695544|NCT01389284|Secondary|Global Assessment of the Investigational Product as a Pain Reliever|Global assessment of investigational product as a pain reliever was rated on a 5-point categorical scale: 0 = poor, 1 = fair, 2 = good, 3 = very good, 4 = excellent|24 hours postdose or immediately before the first intake of rescue medication|Intent-to-treat (ITT)||Participants|||Number
695545|NCT01389284|Secondary|Number of Times the Participants Took Rescue Medication Over the 24-hour Period||24 hours postdose|Intent-to-treat (ITT)||Rescue medication intakes||Standard Deviation|Mean
695546|NCT01389284|Secondary|Cumulative Percentage of Participants Who Took Rescue Medication||At 0.25, 0.5, 0.75, 1, 2, 3, 4 ,5 ,6, 8, 12, 16, 20 and 24 hours postdose|Intent-to-treat (ITT)||Percentage of participants|||Number
695547|NCT01389284|Secondary|Median Time to First Intake of Rescue Medication|Time to first use of rescue medication was estimated using Kaplan-Meier method and analyzed by a logrank test stratified by baseline pain intensity. If at least 50% of subjects in a treatment group took rescue medication, the median time to first rescue was determined for that treatment group.|Up to 24 hours postdose|Intent-to-treat (ITT)||Hours||Full Range|Median
695548|NCT01389284|Secondary|Pain Relief From Initial Dose|Pain Relief was evaluated using the 5-point overall pain relief scale: 0 = No relief, 1 = A little relief, 2 = Some relief, 3 = A lot of relief, 4 = Complete relief|At 0.25, 0.5, 0.75, 1, 2, 3, 4 ,5 ,6, 8, 12, 16, 20 and 24 hours postdose|Intent-to-treat (ITT)||Score on the scale||Standard Deviation|Mean
695549|NCT01389284|Secondary|Pain Intensity Differences (PIDs) by Time From Initial Dose|Pain intensity was evaluated using a 4-point Categorical Pain Intensity Rating Scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe|At 0, 0.25, 0.5, 0.75, 1, 2, 3, 4 ,5 ,6, 8, 12, 16, 20 and 24 hours postdose|Intent-to-treat (ITT)||Score on the scale||95% Confidence Interval|Mean
695550|NCT01389284|Secondary|Summed, Time-weighted Total Pain Relief Scores (TOTPARs)|TOTPARs were derived by multiplying the pain relief score at each post-dose timepoint by the duration (in hours) since the preceding timepoint and then summing these values over the specified interval. Pain Relief was evaluated at 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 24 hours postdose, using the 5-point overall pain relief scale: 0 = No relief, 1 = A little relief, 2 = Some relief, 3 = A lot of relief, 4 = Complete relief. The possible total score ranges of TOTPARs are: TOTPAR0-6: 0 to 18, TOTPAR0-8: 0 to 24, TOTPAR0-12: 0 to 36, TOTPAR0-16: 0 to 48, TOTPAR0-24: 0 to 72, TOTPAR16-24: 0 to 24.|0-6, 0-8, 0-12, 0-16, 0-24, and 16-24 hours postdose|Intent-to-treat (ITT)||Score on the scale||95% Confidence Interval|Mean
695551|NCT01389284|Secondary|Summed, Time-weighted Pain Intensity Differences (SPID)|Pain intensity was measured at baseline, 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 24 hours using the 4-point categorical pain intensity scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total possible score ranges of SPIDs are SPID0-6: -6 to 18, SPID0-8: -8 to 24, SPID0-12: -12 to 36, SPID0-16: -16 to 48, SPID16-24: -8 to 24. The positive SPID value indicates improvement of pain relief. The higher the SPID value, the more improvement of pain relief.|0-6, 0-8, 0-12, 0-16 and 16-24 hours postdose|Intent-to-treat (ITT)||Score on the scale||95% Confidence Interval|Mean
695552|NCT01389284|Primary|Summed, Time-weighted Pain Intensity Difference From 0 to 24 Hours Postdose (SPID0-24)|SPID0-24 was calculated by multiplying the pain intensity difference score at each post-dose timepoint by the duration (in hours) since the preceding timepoint and then summing these values over 0 to 24 hours. Pain intensity was measured at baseline, 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 24 hours using the 4-point categorical pain intensity scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe. SPID0-24 can vary from -24 to 72. The positive SPID value indicates improvement of pain relief. The higher the SPID value, the more improvement of pain relief.|From 0 to 24 hours post-dose|Intent-to-treat (ITT)||Score on the scale||Standard Error|Mean
695553|NCT01389102|Primary|Mean Change the Severity of Moderate to Severe Vasomotor Symptoms|"Patients completed a daily diary to record the number of mild, moderate and severe vasomotor symptoms experienced each day.
Mild, moderate and severe were defined as follows:
Mild = sensation of heat without sweating Moderate = sensation of heat with sweating, ability to continue activity Severe = sensation of heat with sweating, causing discontinuation of activity Severity of hot flushes was measured on a scale of none = 0, mild = 1, moderate = 2 and severe = 3."|baseline to week 12 (12 weeks)|||Scores on a scale||Standard Deviation|Mean
695558|NCT01389076|Secondary|Percentage of Participants That Respond to Treatment|"The overall response rate (PR [partial response] + CR [complete response]) was determined.
Partial response is defined as the regression of measurable disease with no new sites of disease.
Complete response is defined as the disappearance of all evidence of disease."|2 years|||percentage of participants||95% Confidence Interval|Number
695559|NCT01389076|Primary|Rate of Early Onset HAMA (Human Anti-mouse Antibody) Conversion Following Treatment|The percentage of patients that experience early onset HAMA conversion following treatment. Early-onset HAMA is defined as antimouse antibody levels (in blood serum) of at least 5 times the level of detection, occurring at or prior to the 7th week of I-131 tositumomab therapy.|7 weeks|||percentage of participants||95% Confidence Interval|Number
695560|NCT01388946|Secondary|Chronic Pain|Number and incidence of patients with persisting pain (burning pain, loss of sensation) three month postoperatively|three months|Below the number of patients with pain three months postoperatively. For the chronic pain assessment in the control group we had two dropouts as contact for two patients was not feasible.||Number of participants|||Number
695561|NCT01388946|Secondary|Chronic Pain|Number and incidence of patients with persisting pain (burning pain, loss of sensation) one month postoperatively|one month postoperatively|Below the number of patients with pain one month postoperatively For the chronic pain assessment in the control group we had two dropouts as contact for two patients was not feasible.||number of participants|||Number
695562|NCT01388946|Secondary|Pain Scores During Cough 48 h Postoperatively|Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.|48 h|Fifty patients in the Ropivacaine group were analyzed for the primary and secondary outcomes 24 hours postoperatively. One patient in this group presented ileus after the first 24 h and was not assessed for pain 48 h after surgery Below are the VAS values (mean and standard deviation) during cough 48 h postoperatively||mm||Standard Deviation|Mean
695563|NCT01388946|Secondary|Pain Scores During Cough 8 h Postoperatively|Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.|8 h|Fifty patients in the Ropivacaine group were analyzed for the primary and secondary outcomes 24 hours postoperatively. One patient presented ileus after the first 24 h and was not assessed for pain 48 h after surgery Below are the VAS values (mean and standard deviation) 8 h postoperatively||mm||Standard Deviation|Mean
695564|NCT01388946|Secondary|Pain Scores During Cough 4 h Postoperatively|Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.|4 h|Fifty patients in the Ropivacaine group were analyzed for the primary and secondary outcomes 24 hours postoperatively. One patient presented ileus after the first 24 h and was not assessed for pain 48 h after surgery Below are the VAS values (mean and standard deviation) during cough 4 h postoperatively||mm||Standard Deviation|Mean
695565|NCT01388946|Secondary|Pain Scores During Cough 2 h Postoperatively|Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.|2 h|Fifty patients in the Ropivacaine group were analyzed for the primary and secondary outcomes 24 hours postoperatively. One patient presented ileus after the first 24 h and was not assessed for pain 48 h after surgery Below are the VAS values (mean and standard deviation) during cough 2 h postoperatively||mm||Standard Deviation|Mean
695566|NCT01388946|Secondary|Pain Scores During Cough in the PACU|Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.|PACU|Fifty patients in the Ropivacaine group were analyzed for the primary and secondary outcomes 24 hours postoperatively. One patient presented ileus after the first 24 h and was not assessed for pain 48 h after surgery Below are the VAS values (mean and standard deviation) during cough in PACU||mm||Standard Deviation|Mean
695567|NCT01388946|Secondary|Pain Scores at Rest 48 h Postoperatively|Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.|48 h|50 patients in the Ropivacaine group were analyzed for the primary and secondary outcomes 24 hours postoperatively. 1 patient in this group presented ileus after the first 24 h assessment, remaining 49 patients for assessment at 48 hours postoperatively Below are the VAS values (mean and standard deviation) at rest 48 hours postoperatively||mm||Standard Deviation|Mean
695568|NCT01388946|Secondary|Pain Scores at Rest 24 h Postoperatively|Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.|24h|Fifty patients in the Ropivacaine group were analyzed for the primary and secondary outcomes 24 hours postoperatively. One patient presented ileus after the first 24 h and was not assessed for pain 48 h after surgery Below are the VAS values (mean and standard deviation) at rest 24 h postoperatively||mm||Standard Deviation|Mean
695569|NCT01388946|Secondary|Pain Scores at Rest 8 h Postoperatively|Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.|8 h|Fifty patients in the Ropivacaine group were analyzed for the primary and secondary outcomes 24 hours postoperatively. One patient presented ileus after the first 24 h and was not assessed for pain 48 h after surgery Below are the VAS values (mean and standard deviation) at rest 8 h postoperatively||mm||Standard Deviation|Mean
695570|NCT01388946|Secondary|Pain Scores at Rest 4 h Postoperatively|Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.|4 h|Fifty patients in the Ropivacaine group were analyzed for the primary and secondary outcomes 24 hours postoperatively. One patient presented ileus after the first 24 h and was not assessed for pain 48 h after surgery Below are the VAS values (mean and standard deviation) at rest 4 h postoperatively||mm||Standard Deviation|Mean
695571|NCT01388946|Secondary|Pain Scores at Rest 2 h Postoperatively|Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.|2 h postoperatively|"Fifty patients in the Ropivacaine group were analyzed for the primary and secondary outcomes 24 hours postoperatively. One patient presented ileus after the first 24 h and was not assessed for pain 48 h after surgery.
Below are the VAS values (mean and standard deviation) 2 h postoperatively at rest"||mm||Standard Deviation|Mean
695683|NCT01387022|Secondary|Genital Viral Shedding (Viral Load on Tear Flow)||3 years|Data were not collected for this Outcome Measure|||||
695572|NCT01388946|Secondary|Pain Scores in the Postoperative Care Unit (PACU) at Rest|Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.|in PACU|Below is the mean and standard deviation of the VAS scores in PACU at rest Fifty patients in the Ropivacaine group were analyzed for the primary and secondary outcomes 24 hours postoperatively. One patient presented ileus after the first 24 h and was not assessed for pain 48 h after surgery||mm||Standard Deviation|Mean
695573|NCT01388946|Primary|VAS Score Changes ( Cough) During 24 h Postoperatively|Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.|24 h|Fifty patients in the Ropivacaine group were analyzed for the primary (VAS score at cough) and secondary outcomes 24 hours postoperatively. One patient presented ileus after the first 24 h and was not assessed for pain 48 h after surgery||mm||Standard Deviation|Mean
695574|NCT01388920|Secondary|Plasma Glucose|Changes from baseline in fasting blood glucose|6 months||||||
695575|NCT01388920|Secondary|COPD Exacerbations|Frequency and severity of COPD exacerbations|6 months||||||
695576|NCT01388920|Secondary|Adverse Events|Number and percentage of subjects with adverse events|6 months||||||
695577|NCT01388920|Secondary|Change From Baseline in Patient-reported Outcomes at 6 Months||6 months||||||
695578|NCT01388920|Secondary|Change From Baseline in Peripheral Muscle Strength at 6 Months||6 months||||||
695579|NCT01388920|Secondary|Change From Baseline in Exercise Capacity at 6 Months||6 months||||||
695580|NCT01388920|Primary|Change From Baseline in Lean Body Mass at 6 Months|The primary objective of the study was to evaluate the effect of tesamorelin on lean body mass by Dual-energy X-ray absorptiometry (DXA) scan|6 months|The primary objective of the study was the change in lean body mass between baseline and Month 6. However, the study was halted approximately 1 month after patient enrollment.|||||
695581|NCT01388907|Secondary|mAFS Abdominopelvic Adhesion Score|mAFS abdominopelvic adhesion score in 23 sites (at the anterior caudal peritoneum; parietocolic gutter right; right and left colon; right and left anterior cranial peritoneum; rectosigmoid; omentum; small intestine; anterior and posterior uterus; posterior cul-de-sac; right and left ovaries [internal and lateral sides], pelvic side walls, ovarian fossae, tubes, and bulbs). It ranges from 0 (best possible outcome) to 16 (worse possible outcome).|10 to 20 weeks post surgery|||units on a scale||Standard Deviation|Mean
695582|NCT01388907|Secondary|Adnexal Adhesions|Adnexal Adhesions were assessed by AFS score. AFS (= American Fertility Society) score was developed in 1980’s by the American Fertility Society in an effort to address needs for a classification scheme for adnexal adhesions suspected to be associated with infertility. 4 anatomic sites evaluated: R-tube; R-ovary; L-tube; L-ovary. Final AFS score for a patient is the score of the side with lower summed score. The higher score, representing the side with the higher adhesion burden, is dropped; Score AFS is from 0 (best possible outcome) to 32 (worse possible outcome).|10 to 20 weeks post surgery|||units on a scale||Standard Deviation|Mean
695583|NCT01388907|Secondary|Fertility|Fertility was assessed by pregnancy and deliveries rates at 3 years.|3 years|||participants|||Number
695584|NCT01388907|Primary|Number of Patients With Adhesions to Uterine Scars|"The primary endpoint was the assessment of adhesions to uterine scars and comprised the incidence (expressed per patient and per uterine scar), extent, and severity of adhesions observed during the second-look laparoscopy performed 10 to 20 weeks after the myomectomy.
This assessment was made by the surgeon (investigator) on the one hand and by two independent surgeons who reviewed the video recordings on the other hand."|10 to 20 weeks post surgery|Two patients in group Prevadh group were withdrawn from the study, at 1 and 6 days post-myomectomy. One patient was re-operated for compress removal in Prevadh group and was excluded. Two patients in group Lactate Ringer group were withdrawn from the study, at 1 and 6 days post-myomectomy.||participants|||Number
695585|NCT01388816|Secondary|Changes in Other Lipids and Apolipoproteins|Change from baseline (LOCF, ITT population)|28 days|ITT with LOCF||percentage change from baseline||95% Confidence Interval|Least Squares Mean
695586|NCT01388816|Secondary|Changes in CETP Inhibition in Plasma|Percent change from baseline in CETP Inhibition|28 days|ITT with LOCF||percentage from baseline||95% Confidence Interval|Least Squares Mean
695587|NCT01388816|Secondary|To Evaluate Trough Levels of DRL-17822 in Plasma|Trough levels of DRL-17822 in plasma after 28 days of treatment|28 days|||ng/mL||Standard Deviation|Mean
695588|NCT01388816|Secondary|Changes in Vital Signs Including Blood Pressure|Vital sign abnormalities reported as treatment-emergent AEs|28 days|ITT/Safety Population||participants|||Number
695589|NCT01388816|Secondary|Safety and Tolerability of DRL-17822|Incidence of treatment-related adverse events|28 days|Safety/ITT Population||participants|||Number
695590|NCT01388816|Primary|Percent Change in HDL-C From Baseline|Percent change from baseline in HDL-C after 28 days of treatment in patients with Type II hyperlipidemia|28 days|Intention to treat (ITT) analysis with last observation carried forward (LOCF) for missing data.||percent change from baseline||95% Confidence Interval|Least Squares Mean
695591|NCT01388790|Secondary|Median Progression-free Survival (PFS) Time - Independent Review Committee (IRC) Assessments|The PFS time is defined as the duration from start of treatment until radiological progression (based on RECIST v 1.0 criteria) or death due to any cause within 60 days of the last tumor assessment or start of treatment. Participants without event are censored on the date of last tumor assessment.|Time from start of treatment to disease progression, death or last tumor assessment, reported between day of first participant treated, that is July 2011, until cut-off date, (14 August 2012)|ITT population included all participants who received at least one dose of study treatment.||months||95% Confidence Interval|Median
695592|NCT01388790|Primary|Best Overall Response (BOR) Rate - Independent Review Committee (IRC) Assessments|The best overall response rate is defined as the percentage of participants having achieved confirmed complete response plus partial response as the best overall response according to radiological assessments (based on Response Evaluation Criteria in Solid Tumors version 1.0 [RECIST v 1.0] criteria).|Evaluations were performed every 6 weeks until disease progression, reported between day of first participant treated, that is July 2011, until cut-off date, (14 August 2012)|ITT population included all participants who received at least one dose of study treatment.||percentage of participants||95% Confidence Interval|Number
701618|NCT00054717|Secondary|Median Change From Baseline in Viral Load to Week 4||Baseline to Week 4|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Log(Copies/mL)||Inter-Quartile Range|Median
695593|NCT01388647|Other Pre-specified|Dose Limiting Toxicity (DLT)|DLT is defined as grade 4 thrombocytopenia; grade 4 anemia; grade 4 neutropenia lasting > 5 days; or any grade 3 or 4 non-hematologic toxicity occurring during Cycle 1 which is attributable to eribulin, carboplatin, trastuzumab or the combination, or the inability to deliver all three agents at the assigned dose and scheduled time during Cycle 1.The following events are excluded from the DLT definition: grade 3 nausea and/or vomiting responsive to antiemetics; grade 3 fever or infection; grade 3 diarrhea responsive to antidiarrheal therapy.|Approximately 22 days from study treatment start, per subject|||participants|||Number
695594|NCT01388647|Other Pre-specified|Maximum Tolerated Dose (MTD) of Eribulin in Combination With Carboplatin and Trastuzuamb|The MTD is defined as the dose at which <= 1 of 6 subjects experience DLT (Dose Limiting Toxicity) and above which >= 2 of 6 subjects experience DLT.|Approximately 22 days from study treatment start, per subject|The MTD of ECH as neoadjuvant therapy for HER2+ breast cancer was determined per protocol definitions; however, due to the combination of increased hematologic toxicity and possible reduced efficacy, Phase II of this trial was not initiated.||mg/m^2|||Number
695595|NCT01388647|Secondary|Clinical Response|Clinical assessment of response will be performed 3 weeks after completion of study treatment. The treating physician will assess clinical response using physical examination and radiologic evaluation. Clinical response options are complete response (no invasive tumor in breast and lymph nodes), partial response (> 50% reduction in longest diameter of pretreatment tumor), no response (< 50% response to 10% growth of tumor as determined by longest diameter of pretreatment tumor size), and progression.|Assessed prior to definitive surgery, approximately 18 weeks from study treatment start.|||percentage of participants||95% Confidence Interval|Number
695596|NCT01388647|Primary|Pathologic Response|Definitive surgery will be performed 3 to 8 weeks after completion of study treatment. The pathology report will be scored for pathologic response: complete pathologic response (no invasive cancer in breast or lymph nodes; residual DCIS or LCIS is acceptable), partial pathologic response (residual invasive cancer in breast and/or lymph nodes), or no response (pathologic staging is equal to or worse than pretreatment clinical staging).|Assessed at time of definitive surgery, approximately 21-26 weeks from study treatment start|||percentage of participants||95% Confidence Interval|Number
695597|NCT01388530|Secondary|Attention Network Task - Incongruent Reaction Time|"Laboratory measure of response inhibition. The measure assessed the reaction time in milliseconds (ms) using the Attention Network Task (ANT), which is a computerized test designed to evaluate the efficiency of an attention network.
Outcome measure represents a change from Baseline at Week 8 for the ANT - Incongruent reaction time. Lower reaction time is consider a better outcome."|Baseline and Week 8.|Participants with data at baseline and week 4. We included participants who completed 4 weeks of treatment, but comparison is based on Week 8 vs. baseline.||milliseconds (ms).||Standard Deviation|Mean
695598|NCT01388530|Secondary|Conners Global Index - Parent|"A standard, parent completed measure of ADHD symptoms.
Scale range from 0 (best) to 27 (worst).
Unit of Measure - units on a scale.
Outcome value reflects change from baseline at endpoint (Week 8)."|Baseline and Week 8.|Participants with data at baseline and week 4. We required 4 weeks treatment to include in analysis, but analysis is based on comparison of baseline and week 8.||units on a scale||Standard Deviation|Mean
695599|NCT01388530|Secondary|Clinical Global Impression - Improvement (CGI-I)|"A global measure of clinical improvement compared with baseline.
A standard clinical trials rating scale with value from 1 (very much improved) to 7 (very much worse).
Unit of measure - percentage improved based on CGI-I scores of 1 and 2 versus all others."|Week 8|Participants with data at baseline and week 4. As with the ADHD-RS, we included participants with at least 4 weeks of treatment, but outcome was assessed at Visit 8 compared with baseline.||percentage of improved|||Number
695600|NCT01388530|Primary|ADHD-IV Rating Scale (ADHD-RS)|"A standard, frequently used, clinician completed measure of Diagnostic and Statistical Manual -IV (DSM-IV) ADHD symptoms.
Scale ranges from 0 (best) to 54 (worst).
Unit of Measure - units on a scale.
Outcome value reflects change from baseline at endpoint (Week 8) in ADHD-RS."|Baseline and Week 8.|Participants with data at baseline and week 4. We included participants who participated in 4 weeks of treatment, but change comparison is baseline vs. week 8.||units on a scale||Standard Deviation|Mean
695601|NCT01388491|Secondary|Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Sex Hormone Binding Globulin|Normal range for this parameter was 28 to 146 nmol/L. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.|Baseline through Month 6|Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received.||nmol/L||Standard Error|Least Squares Mean
695602|NCT01388491|Secondary|Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Thyroid-Stimulating Hormone (TSH)|Normal range for this parameter was 0.35 to 5.5 mIU/L. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.|Baseline through Month 6|Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received.||mIU/L||Standard Error|Least Squares Mean
695603|NCT01388491|Secondary|Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Serum Random Total Cortisol|Normal range for this adrenal parameter was 85.6 to 618.2 nmol/L. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.|Baseline through Month 6|Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received.||nmol/L||Standard Error|Least Squares Mean
695684|NCT01387022|Secondary|Cellular and Humoral Immune Responses|We will assess whether exposure to tenofovir gel at the time of HIV acquisition alters the subsequent humoral and cellular immune responses following antiretroviral treatment initiation|3 years|Data were not collected for this Outcome Measure|||||
695685|NCT01387022|Secondary|Reported Adverse Events With Severity Grades 3 and 4 Based on the DAIDS Toxicity Grading Tables||From randomisation until either time of termination or time of death|All participants who randomised and initiated on ART||Participants|||Count of Participants
695604|NCT01388491|Secondary|Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Corticosteroid-Binding Globulin|Normal range for this adrenal parameter was 1906.448 to 4520.504 mg/L. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.|Baseline through Month 6|Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received.||mg/L||Standard Error|Least Squares Mean
695605|NCT01388491|Secondary|Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Endogenous Thrombin Potential (EPT)-Based Activated Protein-C (APC) Resistance|This hemostatic parameter is calculated by dividing the clotting time with APC by the clotting time without APC. Normal range for this measure was defined as a ratio of 0.32 to 1.79. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.|Baseline through Month 6|Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received.||ratio||Standard Error|Least Squares Mean
695606|NCT01388491|Secondary|Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Activated Partial Thromboplastin Time (APTT)-Based Activated Protein-C (APC) Resistance|This hemostatic parameter is calculated by dividing the clotting time with APC by the clotting time without APC. Normal range for this measure was defined as a ratio of 2.00 to 3.36. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.|Baseline through Month 6|Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received.||ratio||Standard Error|Least Squares Mean
695607|NCT01388491|Secondary|Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Factor VIII|Normal range for this hemostatic parameter was 50% to 180%. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.|Baseline through Month 6|Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received.||percentage of normal||Standard Error|Least Squares Mean
695608|NCT01388491|Secondary|Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Factor VII|Normal range for this hemostatic parameter was 60% to 150%. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.|Baseline through Month 6|Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received.||percentage of normal||Standard Error|Least Squares Mean
695609|NCT01388491|Secondary|Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Factor II Activity|Normal range for this hemostatic parameter was 70% to 150%. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.|Baseline through Month 6|Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received.||percentage of normal||Standard Error|Least Squares Mean
695610|NCT01388491|Secondary|Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Antithrombin|Normal range for this hemostatic parameter was 75% to 130%. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.|Baseline through Month 6|Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received.||percentage of normal||Standard Error|Least Squares Mean
695611|NCT01388491|Secondary|Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Protein C Activity|The normal range for this hemostatic parameter was 70% to 180%. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.|Baseline through Month 6|Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received.||percentage of normal||Standard Error|Least Squares Mean
695686|NCT01387022|Secondary|Tenofovir Resistance, Defined as Presence of K65R, K70E or Any of the TAMS Mutations||From randomisation until either time of termination or time of death|Resistance testing was only done on participants who were failing first line antiretroviral therapy.||Participants|||Count of Participants
695756|NCT01385644|Secondary|Percentage Change in 6 Minute Walk Distance Compared to Baseline|At 6 months 6 Minute Walk Distance was mesured and compared as a percentage to baseline|Baseline and 6 months post MSC infusion|||percentage of baseline||Inter-Quartile Range|Median
695612|NCT01388491|Secondary|Least Squares Mean Change From Baseline Over the 6-Month Period in Protein S Total Antigen|The normal range for this hemostatic parameter was 50% to 147%. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.|Baseline through Month 6|Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received.||percentage of normal 50% to 147%||Standard Error|Least Squares Mean
695613|NCT01388491|Secondary|Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in D-Dimer|Normal range for this hemostatic parameter was 0 to 729 mcg/L. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.|Baseline through Month 6|Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received.||mcg/L||Standard Error|Least Squares Mean
695614|NCT01388491|Primary|Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Prothrombin Fragment 1 + 2 Levels|Normal range for this hemostatic parameter was 41 to 372 pmol/L. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.|Baseline through Month 6|Per-protocol (PP) population. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received.||pmol/L||Standard Error|Least Squares Mean
695615|NCT01388361|Secondary|Number of Severe and Minor Treatment Emergent Hypoglycaemic Episodes|Corresponds to number of treatment emergent hypoglycaemic events from onset on or after the first day of exposure to investigational product and no later than 7 days after last exposure to investigational product. Confirmed hypoglycaemia was defined as the pool of severe hypoglycaemic episodes and minor episodes with a plasma glucose (PG) value < 3.1 mmol/L (56 mg/dL).|Onset on or after the first day of exposure to investigational product for 26 weeks of treatment period and no later than 7 days after last exposure to investigational product.|The safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or its comparator||events|||Number
695616|NCT01388361|Secondary|Change From Baseline in Body Weight|Corresponds to the values of change in body weight in kilograms from baseline to week 26.|week 0, week 26|Both sets of FAS and NAS included all randomised and non-randomised subjects in the treatment period and missing data was imputed using LOCF. At baseline, the body weight values were missing for 1 subject in IDeg + Liraglutide arm from FAS and 3 subjects in NAS for IDeg arm.||kg||Standard Deviation|Mean
695617|NCT01388361|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|Values for change in FPG in mmol/L from baseline to week 26 of randomised period.|week 0, week 26|Both sets of FAS and NAS included all randomised and non-randomised subjects in the treatment period. The FPG values were missing for 7 subjects in FAS (2 subjects with IDeg+ liraglutide; 5 subjects with IDeg+IAsp arm) and 10 subjects in NAS for IDeg arm at baseline. The missing data was imputed using LOCF.||mmol/L||Standard Deviation|Mean
695618|NCT01388361|Primary|Change From Baseline in HbA1c (%) (Glycosylated Haemoglobin)|Values for change in HbA1c from baseline to 26 weeks of treatment period.|week 0, week 26|The FAS and NAS included all randomised and non-randomised subjects respectively, and missing data was imputed using last observation carried forward (LOCF).||percentage of glycosylated haemoglobin||Standard Deviation|Mean
695619|NCT01388166|Secondary|Mean Change of Morisky Medication Adherence Scale -8 (MMAS-8) Score at the End of the Observational Period After 12 Months From Baseline|The MMAS-8 scale is a recognized indicator of medication adherence, consisting of 8 questions with a sum score ranging between 0 and 8 points. The higher score indicates higher adherence to the prescribed therapy recommendation. It has been agreed that the score of 8 could be categorized as having high adherence, score between 6 and 7 as medium adherence and scores of 5 and less as low adherence. The change is presented as the score on visit 4 minus the score at visit 1 (baseline). Therefore, a positive change score reflects an improvement in the adherence.|12 months and baseline|This patient set includes all patients in the TS who have valid MMAS-8 questionnaire results both at baseline and after 6 months.||units on a scale||Standard Deviation|Mean
695620|NCT01388166|Secondary|Mean Change of Morisky Medication Adherence Scale -8 (MMAS-8) Score at the End of the Observational Period After 12 Months From End of Educational Period After 6 Months.|The MMAS-8 scale is a recognized indicator of medication adherence, consisting of 8 questions with a sum score ranging between 0 and 8 points. The higher score indicates higher adherence to the prescribed therapy recommendation. It has been agreed that the score of 8 could be categorized as having high adherence, score between 6 and 7 as medium adherence and scores of 5 and less as low adherence. The change is presented as the score on visit 4 minus the score at visit 3. Therefore, a positive change score reflects an improvement in the adherence.|6 months and 12 months|This patient set includes all patients in the TS who have valid MMAS-8 questionnaire results after 6 and 12 months.||units on a scale||Standard Deviation|Mean
695621|NCT01388166|Primary|Mean Change of Morisky Medication Adherence Scale -8 (MMAS-8) Score at the End of the Educational Period After 6 Months From Baseline|The MMAS-8 scale is a recognized indicator of medication adherence, consisting of 8 questions with a sum score ranging between 0 and 8 points. The higher score indicates higher adherence to the prescribed therapy recommendation. It has been agreed that the score of 8 could be categorized as having high adherence, score between 6 and 7 as medium adherence and scores of 5 and less as low adherence. The change is presented as the score on visit 3 minus the score at baseline. Therefore, a positive change score reflects an improvement in the adherence.|Baseline and 6 months|This patient set includes all patients in the TS who have valid MMAS-8 questionnaire results both at baseline and after 6 months.||units on a scale||Standard Deviation|Mean
708222|NCT00129246|Primary|Point Prevalence Abstinence|Point prevalence abstinence is defined as the number of patients reporting point prevalence abstinence over the last 7 days.|Week 6|Per protocol analysis||participants|||Number
695622|NCT01387789|Secondary|Change in Health Assessment Questionnaire Short Form 36 (SF-36) Scores From Baseline to 3 Months|The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 “worst”-100 “best”). The standard recall period is four weeks. Increases from baseline indicate improvement. Assessments were conducted at baseline and 3 months.|Baseline and 3 months|||units on a scale||Standard Deviation|Mean
695623|NCT01387789|Secondary|Change in Health Assessment Questionnaire Visual Analog Scale (HAQ-VAS) Scores From Baseline to 3 Months|The Health Assessment Questionnaire Visual Analog Scale (HAQ-VAS) is a patient-reported questionnaire designed to assess the presence or absence of arthritis-related pain and its severity. It consists of a doubly anchored, horizontal VAS, that is scored from 0 (no pain) to 100 (severe pain). Decreases from baseline indicate improvement. Assessments were conducted at baseline and 3 months.|Baseline and 3 months|Participants with available data at this time point||centimeters||Standard Deviation|Mean
695624|NCT01387789|Secondary|Change in Overall Health Assessment Questionnaire Disability Index (HAQ-DI) Scores From Baseline to 3 Months|The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. The minimal clinically important difference (MCID) defined for the HAQ-DI is ≥0.22. HAQ remission indicating normal physical function is defined by HAQ-DI < 0.5. Negative mean changes from baseline in the overall score indicate improvement. Assessments were conducted at baseline and 3 months.|Baseline and 3 months|||units on a scale||Standard Deviation|Mean
695625|NCT01387789|Secondary|Change in Mean Health Assessment Questionnaire Short Form 36 (SF-36) Scores From Baseline to 1 Month|The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 “worst”-100 “best”). The standard recall period is four weeks. Increases from baseline indicate improvement. Assessments were conducted at baseline and 1 month.|Baseline and 1 month|||units on a scale||Standard Deviation|Mean
695626|NCT01387789|Secondary|Change in Health Assessment Questionnaire Visual Analog Scale (HAQ-VAS) Scores From Baseline to 1 Month|The Health Assessment Questionnaire Visual Analog Scale (HAQ-VAS) is a patient-reported questionnaire designed to assess the presence or absence of arthritis-related pain and its severity. It consists of a doubly anchored, horizontal VAS, that is scored from 0 (no pain) to 100 (severe pain). Decreases from baseline indicate improvement. Assessments were conducted at baseline and 1 month.|Baseline and 1 month|Participants with available data at this time point||centimeters||Standard Deviation|Mean
695627|NCT01387789|Secondary|Change in Overall Health Assessment Questionnaire Disability Index (HAQ-DI) Scores From Baseline to 1 Month|The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. The minimal clinically important difference (MCID) defined for the HAQ-DI is ≥0.22. HAQ remission indicating normal physical function is defined by HAQ-DI < 0.5. Negative mean changes from baseline in the overall score indicate improvement. Assessments were conducted at baseline and 1 month.|Baseline and 1 month|||units on a scale||Standard Deviation|Mean
695628|NCT01387789|Primary|Change in Health Assessment Questionnaire Short Form 36 (SF-36) Scores From Baseline to 6 Months|The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 “worst”-100 “best”). The standard recall period is four weeks. Increases from baseline indicate improvement. Assessments were conducted at baseline and 6 months.|Baseline and 6 months|||units on a scale||Standard Deviation|Mean
695629|NCT01387789|Primary|Change in Health Assessment Questionnaire Visual Analog Scale (HAQ-VAS) Scores From Baseline to 6 Months|The Health Assessment Questionnaire Visual Analog Scale (HAQ-VAS) is a patient-reported questionnaire designed to assess the presence or absence of arthritis-related pain and its severity. It consists of a doubly anchored, horizontal VAS, that is scored from 0 (no pain) to 100 (severe pain). Decreases from baseline indicate improvement. Assessments were conducted at baseline and 6 months.|Baseline and 6 months|||centimeters||Standard Deviation|Mean
695687|NCT01387022|Secondary|Change in CD4+ Cell Count From Randomisation to 12 Months Post-randomisation|Difference between 12 months and randomisation CD4+ count was calculated and then summarised|Measured at 12 months post ART initiation|All participants for whom CD4+ count measurements were recorded at randomisation and at 12 months||cells/uL||Inter-Quartile Range|Median
695630|NCT01387789|Primary|Change in Overall Health Assessment Questionnaire Disability Index (HAQ-DI) Scores From Baseline to 6 Months|The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. The minimal clinically important difference (MCID) defined for the HAQ-DI is ≥ 0.22. HAQ remission indicating normal physical function is defined by HAQ-DI < 0.5. Negative mean changes from baseline in the overall score indicate improvement. Assessments were conducted at baseline and 6 months.|Baseline and 6 months|||units on a scale||Standard Deviation|Mean
695631|NCT01387737|Secondary|Change in Blood Pressure||Week 52||||||
695632|NCT01387737|Secondary|Change in Body Weight||Week 52||||||
695633|NCT01387737|Secondary|Change in Fasting Plasma Glucose||Week 52||||||
695634|NCT01387737|Secondary|Change in HbA1c||Week 52||||||
695635|NCT01387737|Primary|Safety and Tolerability Assessed by Adverse Events, Hypoglycemic Events||54 weeks|||percentage of incidences|||Number
695636|NCT01387672|Secondary|Headache|"Severity of headaches. Subjects recorded the severity of headaches upon awakening every day during the run-in phase using a visual analogue scale (VAS). The scale is represented by a line (continuum) 10 cm long. Subjects were asked to make a vertical line along the continuum to indicate the severity of their headache each morning upon awakening. The score is recorded in cm from 0 to 10. A vertical line marked at 0 means no headache (score recorded = 0), a vertical line marked at 10 means a terrible headache (score recorded = 10)."|Run-in phase - 2 days|The mean headache score considering all subjects in each of the treatment/formulation group was calculated.||score on a scale||Standard Deviation|Mean
695637|NCT01387672|Primary|Bone Turnover Markers|"Markers of Bone Formation:
Serum Procollagen type 1 amino- terminal propeptide (P1NP)
Serum Osteocalcin (OC)
Serum Bone-specific alkaline phosphatase (BALP)
Markers of Bone Resorption:
- Serum C-telopeptides of collagen cross-links (CTX)"|3 months|One subject from the Treatment Arm 3 had outlier bone turnover markers values and was excluded from the analysis. Total number of subjects analyzed in Treatment Arm 3 was therefore 32.||Percent change from baseline||Standard Deviation|Mean
695638|NCT01387594|Secondary|Cohorts 1 and 2: Number of Participants With Injection Site Reactions by Severity|Injection site reaction AEs include: injection site irritation, injection site pain, injection site rash, contusion, and erythema.|Baseline till End of Study/Early Withdrawal, up to Week 12|All participants who received at least one dose of study drug.||participants|||Number
695639|NCT01387594|Secondary|Cohorts 1 and 2: Number of Participants Who Developed Anti-Drug Antibodies (ADAs) to PF-00547659|Serum samples were analysed for presence of ADAs to PF-00547659. Participants who showed positive results for PF-00547659 were reported.|Day 1; Weeks 4, 8, 9-11 (Cohort 2 only), 12, 20, 28, and 36; Early Withdrawal|All participants who received at least one dose of study drug.||participants|||Number
695640|NCT01387594|Secondary|Cohorts 1 and 2: Total Number of Participants With Non-Lumbar Puncture (LP) Related Treatment-Emergent Adverse Events (AEs), Withdrawals Due to AEs, and Serious Adverse Events (SAEs) During the 12-week Treatment Period|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect. Treatment-emergent for this measure are events between first dose of study drug and up to 85 days (Week 12) after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included serious and non-serious AEs.|Baseline up to Week 12|All participants who received at least one dose of study drug were analyzed for AEs/safety. Combined data for both cohorts is presented.||participants|||Number
695641|NCT01387594|Primary|Cohort 2: Percent Change From Baseline in Absolute Lymphocyte Count in CSF at Month 3|The primary CSF endpoint of Cohort 2 was the percent change from baseline in absolute lymphocyte counts in CSF after 3 doses of PF-00547659. The hypothesis for the primary endpoint was evaluated using the CSF evaluable population in Cohort 2. CSF samples were obtained via lumbar puncture and analyzed by FACS for total lymphocyte counts. Lumbar punctures were performed by a highly qualified physician using a 20-22 gauge needle, preferably an atraumatic needle.|Baseline, Month 3|All Cohort 2 participants who were enrolled, had 2 evaluable lumbar punctures, and who received all 3 doses of study drug.||percent change||Full Range|Median
695642|NCT01387594|Primary|Cohort 2: Baseline Absolute Lymphocyte Count in Cerebrospinal Fluid (CSF)|The primary CSF endpoint of Cohort 2 was the percent change from baseline in absolute lymphocyte counts in CSF after 3 doses of PF-00547659. The hypothesis for the primary endpoint was evaluated using the CSF evaluable population in Cohort 2. CSF samples were obtained via lumbar puncture and analyzed by fluorescence-activated cell sorting (FACS) for total lymphocyte counts. Lumbar punctures were performed by a highly qualified physician using a 20-22 gauge needle, preferably an atraumatic needle.|Baseline|All Cohort 2 participants who were enrolled, had 2 evaluable LPs, and who received all 3 doses of study drug.||cells per milliliter (cells/mL)||Full Range|Median
695643|NCT01387581|Primary|Specificity|"Dermatologist specificity is the percent of non-melanomas that dermatologists selected not to biopsy. MelaFind specificity is the percent of non-melanomas that MelaFind called Negative."|Within 120 days of Data Lock|||percent of true negatives||95% Confidence Interval|Mean
695644|NCT01387581|Primary|Sensitivity|"Dermatologist sensitivity is the percent of melanomas that dermatologists selected to biopsy. MelaFind sensitivity is the percent of melanomas that MelaFind called Positive."|Within 120 days of Data Lock|||percent of true positives||95% Confidence Interval|Mean
695688|NCT01387022|Primary|The Antiretroviral Treatment Failure Rate at 12 Months.|Treatment failure is defined as viral load > 50 copies/ml, antiretroviral regimen changes for treatment failure or death|12 months post ART intiation or until time of death|All participants who randomised and initiated on ART||participants|||Number
695757|NCT01385644|Secondary|Percentage Change in Lung Function as Assessed by FVC Compared to Baseline|Forced Vital Capacity (FVC) was measured and reported as a percentage of predicted and comapred from 6 months post-infusion to baseline|6 months post MSC infusion|||percentage of baseline||Inter-Quartile Range|Median
695645|NCT01387542|Primary|Change From Baseline in Personal and Social Performance (PSP) Total Score at Week 10|The PSP scale assesses degree of a participant’s dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. Score ranges from 1 to 100, divided into 10 equal intervals to rate degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Based on 4 domains there will be 1 total score. Participants with score of 71 to 100 have mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision.|Baseline, Week 10|Intent-To-Treat (ITT) population included participants who received at least 1 dose of study medication and had at least one post-baseline efficacy evaluation.||Units on a scale||Standard Deviation|Mean
695646|NCT01387542|Primary|Change From Baseline in Personal and Social Performance (PSP) Total Score at Week 6|The PSP scale assesses degree of a participant’s dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. Score ranges from 1 to 100, divided into 10 equal intervals to rate degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Based on 4 domains there will be 1 total score. Participants with score of 71 to 100 have mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision.|Baseline, Week 6|Intent-To-Treat (ITT) population included participants who received at least 1 dose of study medication and had at least one post-baseline efficacy evaluation.||Units on a scale||Standard Deviation|Mean
695647|NCT01387542|Primary|Change From Baseline in Personal and Social Performance (PSP) Total Score at Week 2|The PSP scale assesses degree of a participant’s dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. Score ranges from 1 to 100, divided into 10 equal intervals to rate degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Based on 4 domains there will be 1 total score. Participants with score of 71 to 100 have mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision.|Baseline, Week 2|Intent-To-Treat (ITT) population included participants who received at least 1 dose of study medication and had at least one post-baseline efficacy evaluation.||Units on a scale||Standard Deviation|Mean
695648|NCT01387542|Primary|Change From Baseline in Clinical Global Impression Severity (CGI-S) Scale at Week 10|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher scores indicate worsening ."|Baseline, Week 10|Intent-To-Treat (ITT) population included participants who received at least 1 dose of study medication and had at least one post-baseline efficacy evaluation.||Units on a scale||Standard Deviation|Mean
695649|NCT01387464|Primary|Mean Aqueous Humor Bromfenac Concentration||Approximately 3 hours post last dose|Per-Protocol Population||ng/mL||Standard Deviation|Mean
695650|NCT01387347|Secondary|Number of Adverse Events as a Measure of Safety and Tolerability|The Adverse events, which will be followed, are: impairment of visual acuity, an increase in intraocular pressure (IOP), and an increase in corneal sensitivity in both eyes.|Throughout the study till Day 29|Intention to treat (ITT)||Events|||Number
695651|NCT01387347|Primary|Ocular Discomfort in the Worst Eye in the Controlled Adverse Environment(CAE) Model, Which is a Regulated Environmental Setting Aimed at Exacerbating the Signs and Symptoms of Dry Eye.|"Dry eye causes ocular discomfort, which is measured using a validated 4-point ORA Scale from the start of the dosing till the end of treatment (Day 29). 0 = no discomfort to 4 = constant discomfort.
If the measurement is lower, then improvement of ocular discomfort can be inferred. The test is carried out throughout the study till end of treatment Day 29. However, the primary outcome measure itself is determined on Day 29.
Worst eye: In the case that both eyes were eligible for analysis, the worst eye was chosen as the eye with the greater increase of inferior corneal staining from Visit 1 to Visit 2. If both eyes were equal, the eye with greater ocular discomfort at Visit 2 was chosen as the worst eye. If both eyes had were equal at Visit 2, then the right eye was chosen as the worst eye."|Day 29 (end of treatment)|Intent to Treat (ITT)||Units on a Scale||Standard Deviation|Mean
695652|NCT01387347|Primary|Corneal Staining (Inferior Region) in the Worst Eye in the Controlled Adverse Environment (CAE) Model, Which is a Regulated Environmental Setting Aimed at Exacerbating the Signs and Symptoms of Dry Eye|"This is a test that uses orange dye (fluorescein) and a blue light to detect ocular surface defects associated with dry eye. If the test result is normal, the dye remains in the tear film on the surface of the eye and does not adhere to the eye itself. The test is carried out throughout the study till end of treatment Day 29. However, the primary outcome measure itself is determined on Day 29. The scale used to determine the difference in corneal fluorescein staining between RGN-259 and placebo is the ORA scale: 0= no staining (no detectable ocular defect)to 4= confluent staining( severe ocular defect).
Worst eye: In the case that both eyes were eligible for analysis, the worst eye was chosen as the eye with the greater increase of inferior corneal staining from Visit 1 to Visit 2. If both eyes were equal, the eye with greater ocular discomfort at Visit 2 was chosen as the worst eye. If both eyes were equal at Visit 2, then the right eye was chosen as the worst eye."|Day 29 (end of treatment)|Intent to Treat population||units on a scale||Standard Deviation|Mean
696396|NCT01378962|Secondary|Percentage of Participants Who Died||Every 8 weeks during treatment, after discontinuation participants were followed for up to 1 year after enrollment of the last participant (maximum up to 27 months)|ITT population.||percentage of participants|||Number
695663|NCT01387230|Secondary|Change From Baseline in Serial FEV1 Over 24 Hours Post-dose at Days 1 and 84 (Week 12)|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Serial FEV1 measurements were taken electronically by spirometry. Serial FEV1 measurements of interest for Day 1 were collected at 1, 3, 6, 23 and 24 hours post-dose on Day 1 and for Day 84, the measures were pre-dose (24 hours post-dose of Day 83 morning dose but prior to Day 84’s dose) and 1, 3, 6, 23 and 24 hours post dose on Day 84. Baseline is the mean of the two assessments made 30 minutes and 5 minutes pre-dose on Day 1. Change from Baseline was calculated as FEV1 value at the evaluated time point minus Baseline. Analysis performed separately by Visit/Day using a repeated measures model with covariates of treatment, Baseline, smoking status, center group, time, time by Baseline and time by treatment interactions.|Baseline, Day 1 and Day 84|ITT Population. All participants with >=1 post-BL assessment and non-missing covariate data are included in the analysis. Different participants may have been analyzed at different time points (represented by n=X, X, X in the category titles), so the overall number of participants analyzed reflects everyone in the ITT Population.||Liters||Standard Error|Least Squares Mean
695689|NCT01386983|Secondary|Dollar Amount of Enlarged Prostate (EP)-Related Medical Costs Incurred Per Month|EP-related charges were defined as medical claims submitted to The Health Alliance Plan (HAP), a Health Maintenance Organization (HMO) owned and operated by the Henry Ford Heath System (HFHS) for reimbursement and internal billing data that had a primary diagnosis of EP. Charges were assessed during months 5 to 12 of the variable follow-up period. Follow-up could end only due to end of continuous eligibility, end of study period, or end of 1-year follow-up. Charges were computed on a per-month basis due to differences in the length of follow-up in the sample.|3 months prior to and 12 months following index date|Enrolled Population||dollars||95% Confidence Interval|Mean
695664|NCT01387230|Secondary|Change From Baseline in Weighted Mean (WM) 0-6 Hour FEV1 Obtained Post-dose at Days 1, 28 (Week 4) and 84 (Week 12)|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The WM FEV1 was derived by calculating the area under the FEV1/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. The WM was calculated at Days 1, 28, and Day 84 using the 0-6-hour post-dose FEV1 measurements collected on that day, which included pre-dose (Day 1: 30 minutes [min] and 5 min prior to dosing; other serial visits: 23 and 24 hours after the previous morning dose) and post-dose at 1 hour, 3 hours, and 6 hours. Change from Baseline was the WM minus Baseline. Analysis was performed using a repeated measures model with covariates of treatment, Baseline (mean of the two assessments made 30 minutes and 5 minutes pre-dose on Day 1), smoking status, center group, day, and day by Baseline and day by treatment interactions.|Baseline and Days 1, 28 and 84|ITT Population. All participants with >=1 post-BL assessment and non-missing covariate data are included in the analysis. Different participants may have been analyzed at different time points (represented by n=X, X, X in the category titles), so the overall number of participants analyzed reflects everyone in the ITT Population.||Liters||Standard Error|Least Squares Mean
695665|NCT01387230|Primary|Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 85|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 measurements were taken electronically by spirometry on Days 2, 14, 28, 56, 84, and 85. Baseline is defined as the mean of the assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1. Trough FEV1 is defined as the mean of the FEV1 values obtained at 23 and 24 hours after the previous morning's dosing (ie., trough FEV1 on Day 85 is the mean of the FEV1 values obtained 23 and 24 hours after the morning dosing on Day 84). Change from Baseline was calculated as the trough FEV1 minus the Baseline. Analysis was performed using a repeated measures model with covariates of treatment, Baseline , smoking status, center group, day, and day by Baseline and day by treatment interactions.|Baseline and Day 85|Intent-to-Treat (ITT) Population: all randomized par. who received >=1 dose of study drug. Par. analyzed are those with data available at the presented time point; but, all par. without missing covariate information and with >=1 post-BL measurement were included in the analysis.||Liters||Standard Error|Least Squares Mean
695666|NCT01387178|Secondary|Number of COPD-related Healthcare Encounters||1 year|A subpopulation of participants with an index date between January 1, 2004 and September 30, 2007||number of encounters|||Number
695667|NCT01387178|Primary|Mean Number of COPD Exacerbations|Moderate COPD exacerbations were defined as the occurrence of a COPD-related emergency department (ED) visit or a COPD-related office visit that is closely followed by a prescription claim for oral steroids or antibiotics. Severe exacerbations were defined as the occurrence of a COPD-related hospital admission.|1 year|The total population including participants with index dates between January 1,2004 and June 30, 2008.||number of exacerbations||Standard Deviation|Mean
695668|NCT01387178|Primary|Post-index Period COPD-related, Unadjusted Costs|The mean cost per participant for COPD-related healthcare interventions for one year following the index date (first pharmacy claim for fluticasone propionate/salmeterol 250 µg/50 µg [FSC] or tiotropium bromide [TIO]) was calculated. Total medical costs included inpatient, emergency department, and outpatient costs associated with the treatment of COPD. Total pharmacy costs included costs of all COPD-related medications, and total healthcare costs included all medical and pharmacy costs that were related to COPD treatment. These costs were unadjusted and reflect the actual costs.|1 year|A subpopulation of participants with an index date between January 1, 2004 and September 30, 2007||United States (US) dollars||Standard Deviation|Mean
695669|NCT01387139|Secondary|Nurse Satisfaction|Measured on a 10-point scale (1= least satisfied, 10= most satisfied)|After procedure is completed, on average less than 1 hour|||units on a scale||Inter-Quartile Range|Median
695670|NCT01387139|Secondary|Physician Performing Procedure Satisfaction|Measured on a 10-point scale (1= least satisfied, 10= most satisfied)|After procedure is completed, on average less than 1 hour|||units on a scale||Inter-Quartile Range|Median
695671|NCT01387139|Secondary|Parent Satisfaction|Measured on a 10-point scale (1= least satisfied, 10= most satisfied)|After procedure is completed, on average less than 1 hour|||units on a scale (1-10)||Inter-Quartile Range|Median
695672|NCT01387139|Secondary|Efficacy of Sedation|"Efficacy is defined as:
The patient does not have unpleasant recall of the procedure.
The patient did not experience sedation-related adverse events resulting in abandonment of the procedure or a permanent complication or an unplanned admission to the hospital or prolonged emergency department (ED) observation
The patient did not actively resist or require physical restraint for completion of the procedure. The need for minimal redirection of movements should not be considered as active resistance or physical restraint.
The procedure was successful"|After procedure is completed, on average less than 1 hour|||participants|||Number
695673|NCT01387139|Secondary|Recovery Time|Time until the patient has a Vancouver Sedation Recovery Scale Score of 18 or greater.|Once Vancouver Sedation Recovery Scale Score reaches 18 or greater, on average less than 1 hour|||minutes||Inter-Quartile Range|Median
695674|NCT01387139|Primary|Frequency of Adverse Events|We will record all adverse events during the sedation, and then perform a follow-up call to determine if any additional adverse events occured after discharge.|From enrollment through completion of follow-up, up to 7 days|Adverse events||participants|||Number
695675|NCT01387074|Primary|Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Thumb at Week 24|The MAS assessed the degree of muscle tone during movement of the thumb compared to normal muscle tone using a 6-point scale where: 0=no increase in muscle tone, 1=Slight increase in muscle tone manifested by a catch and release or by minimal resistance at the end of the range of motion when the part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). The number of participants in each score category is presented.|Week 24|Participants from the Efficacy population (all participants who received BOTOX® not previously treated with botulinum toxin) who had data available for this outcome measure.||Participants|||Number
695699|NCT01386788|Primary|Overall Survival After 24 Hours|Number of participants who survived at 24 hours after smoke inhalation were reported.|24 hours|||participants|||Number
695676|NCT01387074|Primary|Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Thumb at Baseline|The MAS assessed the degree of muscle tone during movement of the thumb compared to normal muscle tone using a 6-point scale where: 0=no increase in muscle tone, 1=Slight increase in muscle tone manifested by a catch and release or by minimal resistance at the end of the range of motion when the part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). The number of participants in each score category is presented.|Baseline|Efficacy population included all participants who received BOTOX® not previously treated with botulinum toxin.||Participants|||Number
695677|NCT01387074|Primary|Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Fingers at Week 24|The MAS assessed the degree of muscle tone during movement of the fingers compared to normal muscle tone using a 6-point scale where: 0=no increase in muscle tone, 1=Slight increase in muscle tone manifested by a catch and release or by minimal resistance at the end of the range of motion when the part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). The number of participants in each score category is presented.|Week 24|Participants from the Efficacy population (all participants who received BOTOX® not previously treated with botulinum toxin) who had data available for this outcome measure.||Participants|||Number
695678|NCT01387074|Primary|Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Fingers at Baseline|The MAS assessed the degree of muscle tone during movement of the fingers compared to normal muscle tone using a 6-point scale where: 0=no increase in muscle tone, 1=Slight increase in muscle tone manifested by a catch and release or by minimal resistance at the end of the range of motion when the part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). The number of participants in each score category is presented.|Baseline|Efficacy population included all participants who received BOTOX® not previously treated with botulinum toxin.||Participants|||Number
695679|NCT01387074|Primary|Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Wrist at Week 24|The MAS assessed the degree of muscle tone during movement of the wrist compared to normal muscle tone using a 6-point scale where: 0=no increase in muscle tone, 1=Slight increase in muscle tone manifested by a catch and release or by minimal resistance at the end of the range of motion when the part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). The number of participants in each score category is presented.|Week 24|Participants from the Efficacy population (all participants who received BOTOX® not previously treated with botulinum toxin) who had data available for this outcome measure.||Participants|||Number
695680|NCT01387074|Primary|Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Wrist at Baseline|The MAS assessed the degree of muscle tone during movement of the wrist compared to normal muscle tone using a 6-point scale where: 0=no increase in muscle tone, 1=Slight increase in muscle tone manifested by a catch and release or by minimal resistance at the end of the range of motion when the part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). The number of participants in each score category is presented.|Baseline|Efficacy population included all participants who received BOTOX® not previously treated with botulinum toxin.||Participants|||Number
695681|NCT01387074|Primary|Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Elbow at Week 24|The MAS assessed the degree of muscle tone during movement of the elbow compared to normal muscle tone using a 6-point scale where: 0=no increase in muscle tone, 1=Slight increase in muscle tone manifested by a catch and release or by minimal resistance at the end of the range of motion when the part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). The number of participants in each score category is presented.|Week 24|Participants from the Efficacy population (all participants who received BOTOX® not previously treated with botulinum toxin) who had data available for this outcome measure.||Participants|||Number
695682|NCT01387074|Primary|Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Elbow at Baseline|The MAS assessed the degree of muscle tone during movement of the elbow compared to normal muscle tone using a 6-point scale where: 0=no increase in muscle tone, 1=Slight increase in muscle tone manifested by a catch and release or by minimal resistance at the end of the range of motion when the part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). The number of participants in each score category is presented.|Baseline|Efficacy population included all participants who received BOTOX® not previously treated with botulinum toxin.||Participants|||Number
695690|NCT01386983|Primary|Number of Participants With Clinical Progression|Participants with clinical progression are defined as those with acute urinary retention and/or receiving prostate-related surgery.|3 months prior to and 12 months following index date|Participants with enlarged prostate during the enrollment period (EP)/pre-index period; treated with AB and 5ARI within 180 days of index date (ID), or 5ARI only, in the EP; and with continuous Health Maintenance Organization enrollment (access to medical/pharmacy services) for at least 3 months prior to and 5 months of ID.||participants|||Number
695691|NCT01386944|Secondary|Change in Treatment Regimen Used for Switching to Neupro® up to 28 Days After Entering in the Study|Case reports from clinical practice refer to different switching regimens for patients taking oral dopaminergics who experienced augmentation and then switched to Neupro®. The previous dopaminergic treatment might have been partly or completely down-titrated prior to switching to Neupro®. Physicians were requested to document the change of treatment at each recommended visit in the electronic Case Report Form (eCRF) considering their total clinical experience with this particular Restless Legs Syndrome (RLS) patients population. Documentation comprised changes in the RLS medication last prescribed, and the dosage of Neupro® and concomitant medications. The change of treatment regimen was entirely at the physicians’ discretion.|From Baseline up to 28 days|The Analysis Population refers to the Eligibility Completer Set (ECS). The ECS is a subset of the Completer Set excluding patients with Parkinson’s disease and/or treated Polyneuropathy as concomitant disease identified by the preferred term (PT) of the MedDRA coding and patients treated with Neupro up to 4 weeks before Visit 1.||participants|||Number
695692|NCT01386944|Primary|Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 7|"The CGI scales document a global assessment of the severity of RLS at single visits according to the treating physician. To this end the physician judges severity of disease by following a simple seven step severity rating scale:
= Normal, not ill at all
= Borderline ill
= Mildly ill
= Moderately ill
= Markedly ill
= Severely ill
= Among the most extremely ill subjects
A negative change from Baseline to Visit 7 indicates an improvement in CGI Item 1."|From Baseline up to 13 months|The Analysis Population refers to the Full Analysis Set (FAS). The FAS is a subset of the Safety Set and consists of all patients who received treatment with Neupro at least once and had a Visit 1 and at least one post-Visit 1 measurement on the primary variable documented.||score on a scale||Standard Deviation|Mean
695693|NCT01386944|Primary|Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 6|"The CGI scales document a global assessment of the severity of RLS at single visits according to the treating physician. To this end the physician judges severity of disease by following a simple seven step severity rating scale:
= Normal, not ill at all
= Borderline ill
= Mildly ill
= Moderately ill
= Markedly ill
= Severely ill
= Among the most extremely ill subjects
A negative change from Baseline to Visit 6 indicates an improvement in CGI Item 1."|From Baseline up to 10 months|The Analysis Population refers to the Full Analysis Set (FAS). The FAS is a subset of the Safety Set and consists of all patients who received treatment with Neupro at least once and had a Visit 1 and at least one post-Visit 1 measurement on the primary variable documented.||score on a scale||Standard Deviation|Mean
695694|NCT01386944|Primary|Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 5|"The CGI scales document a global assessment of the severity of RLS at single visits according to the treating physician. To this end the physician judges severity of disease by following a simple seven step severity rating scale:
= Normal, not ill at all
= Borderline ill
= Mildly ill
= Moderately ill
= Markedly ill
= Severely ill
= Among the most extremely ill subjects
A negative change from Baseline to Visit 2 indicates an improvement in CGI Item 1."|From Baseline up to 7 months|The Analysis Population refers to the Full Analysis Set (FAS). The FAS is a subset of the Safety Set and consists of all patients who received treatment with Neupro at least once and had a Visit 1 and at least one post-Visit 1 measurement on the primary variable documented.||score on a scale||Standard Deviation|Mean
695695|NCT01386944|Primary|Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 4|"The CGI scales document a global assessment of the severity of RLS at single visits according to the treating physician. To this end the physician judges severity of disease by following a simple seven step severity rating scale:
= Normal, not ill at all
= Borderline ill
= Mildly ill
= Moderately ill
= Markedly ill
= Severely ill
= Among the most extremely ill subjects
A negative change from Baseline to Visit 4 indicates an improvement in CGI Item 1."|From Baseline up to 4 months|The Analysis Population refers to the Full Analysis Set (FAS). The FAS is a subset of the Safety Set and consists of all patients who received treatment with Neupro at least once and had a Visit 1 and at least one post-Visit 1 measurement on the primary variable documented.||score on a scale||Standard Deviation|Mean
695696|NCT01386944|Primary|Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 3|"The CGI scales document a global assessment of the severity of RLS at single visits according to the treating physician. To this end the physician judges severity of disease by following a simple seven step severity rating scale:
= Normal, not ill at all
= Borderline ill
= Mildly ill
= Moderately ill
= Markedly ill
= Severely ill
= Among the most extremely ill subjects
A negative change from Baseline to Visit 3 indicates an improvement in CGI Item 1."|From Baseline up to 28 days|The Analysis Population refers to the Full Analysis Set (FAS). The FAS is a subset of the Safety Set and consists of all patients who received treatment with Neupro at least once and had a Visit 1 and at least one post-Visit 1 measurement on the primary variable documented.||score on a scale||Standard Deviation|Mean
695697|NCT01386944|Primary|Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 2|"The CGI scales document a global assessment of the severity of RLS at single visits according to the treating physician. To this end the physician judges severity of disease by following a simple seven step severity rating scale:
= Normal, not ill at all
= Borderline ill
= Mildly ill
= Moderately ill
= Markedly ill
= Severely ill
= Among the most extremely ill subjects
A negative change from Baseline to Visit 2 indicates an improvement in CGI Item 1."|From Baseline up to 7 days|The Analysis Population refers to the Full Analysis Set (FAS). The FAS is a subset of the Safety Set and consists of all patients who received treatment with Neupro at least once and had a Visit 1 and at least one post-Visit 1 measurement on the primary variable documented.||score on a scale||Standard Deviation|Mean
695698|NCT01386788|Primary|Serum Cyanide Levels||blood sampling within 2 hours after smoke inhalation|All recruited patients that met all inclusion criteria including blood sampling for cyanide serum level||participants|||Number
695715|NCT01386632|Secondary|Two-year and Five-year Progression-free Survival Rate in Locally Advanced Head and Neck Squamous Cell Carcinoma in Patients Receiving Concurrent Cisplatin, Radiation Therapy, and DCA.|Progression will be determined using RECIST 1.1 definition of 20% increase in the sum of the diameters of target lesions, in either primary or nodal lesions or the appearance of one or more new lesion(s) and/or unequivocal progression of existing non-target lesions.|Year 5||06/2020||||
695716|NCT01386632|Secondary|Two-year Progression-free Survival Rate in Locally Advanced Head and Neck Squamous Cell Carcinoma in Patients Receiving Concurrent Cisplatin, Radiation Therapy, and DCA.|"Outcome of tumor change will be compared in two separate ways. First, change in measured tumor size at 8 weeks and 3 months will be compared using standard linear models methods (using appropriate transformation to reduce statistical skew).
Progression was determined using RECIST 1.1 definition of 20% increase in the sum of the diameters of target lesions, in either primary or nodal lesions or the appearance of one or more new lesion(s) and/or unequivocal progression of existing non-target lesions."|Year 2|||percentage of patients||95% Confidence Interval|Number
695717|NCT01386632|Primary|Percentage of Participants Who Experienced Adverse Events During Treatment.|Percentage of Participants Who Experienced Adverse Events During Treatment including but are not limited to mucositis, leucopenia, neuropathy, and treatment breaks. This will be done according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0|Adverse events (AE) will be assessed from the time the subject begins the study until the 30-days after receiving the last dose of the study medication.|||percentage of patients||95% Confidence Interval|Number
695718|NCT01386606|Other Pre-specified|Enclomiphene Pharmacokinetic Parameters at Week 6 - AUC0-24.|The area under the curve for plasma concentration over time from zero to 24 hours (AUC0-24).|Week 6|PK population||ng*h/mL||Standard Deviation|Mean
695719|NCT01386606|Other Pre-specified|Enclomiphene Pharmacokinetic Parameters at Week 6 - Tmax.|The Tmax for plasma concentration.|Week 6|PK population||h||Standard Deviation|Mean
695720|NCT01386606|Secondary|Change in Follicle Stimulating Hormone (FSH)|Changes in morning FSH after continuous dosing|Baseline, Week 2, Week 4, Week 6|ITT, subjects who received at least one dose of study drug and had at least one post-dose efficacy measure.||mIU/mL||Standard Deviation|Mean
695721|NCT01386606|Other Pre-specified|Enclomiphene Pharmacokinetic Parameters at Week 6 - Cmax.|The Cmax for plasma concentration.|Week 6|PK population||ng/mL||Standard Deviation|Mean
695722|NCT01386606|Post-Hoc|Morning Testosterone Correlated With Serial Testosterone.|"9 AM morning testosterone correlated with Week 6 serial testosterone Cavg, Cmin, and Cmax.
If a subject did not have a Week 6 serial testosterone Cavg, Cmin, or Cmax then they were not included for that particular correlation calculation."|Week 6|All Androxal subjects with Week 6 serial testosterone measurements.||Number of Subjects|||Number
695723|NCT01386606|Secondary|Change in Leuteinizing Hormone (LH)|Changes in morning LH after continuous dosing|Baseline, Week 2, Week 4, Week 6|ITT, subjects who received at least one dose of study drug and had at least one post-dose efficacy measure.||mIU/mL||Standard Deviation|Mean
695724|NCT01386606|Primary|24 Hour Average and Maximum Testosterone Concentration|"The primary efficacy endpoint will be 24-hour average (TTavg) and maximum (TTmax) testosterone concentration compared to baseline after 6 weeks of treatment.
Time points (in hours after dosing) at which testosterone concentration was measured are: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24."|Baseline and Week 6|ITT, subjects who received at least one dose of study drug and had at least one post-dose efficacy measure.||ng/dL||Standard Deviation|Mean
695725|NCT01386528|Secondary|Incidence of Inhibitors Against FIX (Coagulation Factor Nine)|Number of patients with inhibitory antibodies|During the trial period (2-8 weeks prior to day of surgery (transferred subjects) or 2-4 weeks prior to day of surgery (new subjects) and every 4 weeks after post-operative period (day 1 to day 13)|The full analysis set consisted of all patients exposed to nanacog beta pegol.||patients|||Number
695726|NCT01386528|Secondary|Incidence of Serious Adverse Events (SAE)|The number of serious adverse events per patient years of exposure, reported during the trial period. Number is the only available option here, the data presented are rate of AEs.|During the trial period (2-8 weeks prior to day of surgery (transferred subjects) or 2-4 weeks prior to day of surgery (new subjects) until 4 weeks after post-operative period (day 1 to day 13)|The safety analysis set consisted of all patients exposed to nanacog beta pegol.||Events per patient year of exposure|||Number
695727|NCT01386528|Secondary|Incidence of Adverse Events (AEs)|The number of adverse events per patient years of exposure, reported during the trial period. Number is the only available option here, the data presented are rate of AEs.|during the trial period (2-8 weeks prior to day of surgery (transferred subjects) or 2-4 weeks prior to day of surgery (new subjects) until 4 weeks after post-operative period (day 1 to day 13)|The safety analysis set consisted of all patients exposed to nanacog beta pegol.||events per patient year of exposure|||Number
695728|NCT01386528|Secondary|Haemoglobin Pre- and Post-surgery Start|The mean pre-surgery and post surgery haemoglobin level.|0, 1 hour, 24 hours.|The full analysis set consisted of all patients exposed to nanacog beta pegol.||mmol/L||Standard Deviation|Mean
695729|NCT01386528|Secondary|Transfusion Requirements (Fulfilling Transfusion Criteria)|Mean quantity of transfusion during surgery (the time from knife to skin until last stitch) and the postoperative period (Day 1-13).None of the patients required transfusions beyond Day 6 hence no values presented for days 7-13.|during surgery (the time from knife to skin until last stitch) and post-operative period (day 1 to day 13)|The full analysis set consisted of all patients exposed to nanacog beta pegol.||mL||Standard Deviation|Mean
695730|NCT01386528|Secondary|Consumption of NNC-0156-0000-0009 (U/kg Body Weight)|Mean consumption of nonacog beta pegol (U/kg) used for treatment per patient before surgery, during surgery (the time from knife to skin until last stitch) and post-operative period.|During surgery (the time from knife to skin until last stitch) and post-operative period (day 1 to day 13)|The full analysis set consisted of all patients exposed to nanacog beta pegol.||U/Kg||Standard Deviation|Mean
695754|NCT01385696|Primary|Percentage of Patients Who Prefer Genuair Device Versus Handihaler Device at Visit 2|Patients will be asked to answer which device they prefer after 2 weeks of daily practice (visit 2)|14 days|ITT: all randomized patients who used both devices at least once and expressed a preference for either or neither inhaler. 24 patients (12 each arm) received the incorrect treatment allocation and were excluded from the ITT population. Missing data was handled via the observed cases approach.||Percentage of Patients|||Number
695731|NCT01386528|Primary|Haemostatic Effect During Surgery Evaluated by the Four-point Response Scale (Excellent, Good, Moderate, Poor)|"Haemostatic effect during surgery was evaluated immediately after surgery (last stitch) using a fourpoint response scale:
– Four-point response scale: Excellent, good, moderate, poor. The evaluation was done by the surgeon, anaesthesiologist and/or investigator based on experience as follows:
Excellent: Better than expected/predicted in this type of procedure.
Good: As expected in this type of procedure.
Moderate: Less than optimal for the type of procedure but haemostatic response maintained without change of treatment regimen.
Poor: Bleeding due to inadequate therapeutic response with adequate dosing, change of regimen required."|At the day of surgery|The full analysis set consisted of all patients exposed to nanacog beta pegol.||Haemostatic responses|||Number
695732|NCT01386125|Primary|Change From Baseline in Total Polyp Size Score|An endoscopic nasal examination was performed by the Investigator. Bilateral nasal polyps were scored as follows for each notril (left and right): 0=no polyps, 1=polyps in middle meatus not reaching below inferior border of middle turbinate, 2=polyps reaching below inferior border of middle turbinate but not inferior border of inferior turbinate, 3=large polyps reaching to or below the lower borders of the inferior turbinate or polyps medial to the middle turbinate. Total polyp size score ranged from 0 to 6 (scored 0 to 3 for each nostril), with a lower score indicating smaller-sized polyps. LS Mean Change from Baseline = LS Mean Score for Week 16 - LS Mean Score for Baseline.|Baseline and Week 16|The FAS population consisted of all randomized participants who received at least one dose of study treatment and who had a baseline and at least one post-baseline efficacy assessment.||score on a scale||Standard Error|Least Squares Mean
695733|NCT01386125|Primary|Change From Baseline in Congestion/Obstruction Score|At Baseline, the Investigator and participant jointly evaluated the signs and symptoms of congestion/obstruction. After Baseline, participants scored the signs and symptoms of congestion/obstruction every morning immediately prior to dosing using a morning instantaneous congestion/obstruction score. This score reflected the participant's condition at that time (instantaneous) and ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3= severe), with a lower score indicating less congestion/obstruction. Congestion/obstruction scores were averaged over Weeks 1-4 of the treatment period. Data are compared using Least Square (LS) Means. LS Mean Change from Baseline = LS Mean Score averaged over Weeks 1-4 - LS Mean Score for Baseline.|Baseline and Weeks 1-4|The Full Analysis Set (FAS) population consisted of all randomized participants who received at least one dose of study treatment and who had a baseline and at least one post-baseline efficacy assessment.||score on a scale||Standard Error|Least Squares Mean
695734|NCT01386008|Secondary|Investigator Fit Preference|Investigator Fit Preference rated on a linear scale (Lens assessment biomicroscopy: 1=strong R, 2=slight R, 3=No Pref, 4=slight L, 5=strong L)|V1 (Initial), V2 (Day-7), V3 (Day-14), V4 (Day-30)|Not all subjects completed the study measures at each outcome measurement time frame before the study was terminated. 20 participants completed V1 and only 1 participant completed the V2 follow-up. V3 and V4 cannot be analyzed.||participants|||Number
695735|NCT01386008|Primary|Ocular Health|Ocular health determined by biomicroscopy recorded on a severity scale (0-4) for change from baseline over 30 days.|Change from baseline over 30 days measured at V1 (Initial), V2 (Day-7), V3 (Day-14), V4 (Day-30)|Not all subjects completed the study measures at each outcome measurement time frame before the study was terminated. 20 participants completed V1 and only 1 participant completed the V2 follow-up. Change from baseline V1 over 30 days V4 cannot be analyzed.|||||
695736|NCT01386008|Primary|Subjective Comfort Preference - Participants Preference Response|Subjective responses of participants administered by questionnaire and measured on a linear scale (0-100) measured at each visit.|V1 (Initial), V2 (Day-7), V3 (Day-14), V4 (Day-30)|Not all subjects completed the study measures at each outcome measurement time frame before the study was terminated. 20 participants completed V1 and only 1 participant completed the V2 follow-up. V3 and V4 cannot be analyzed.||participants|||Number
695737|NCT01386008|Secondary|Investigator Surface Preference|Investigator Surface Preference rated on a linear scale (Lens assessment biomicroscopy: 1=strong R, 2=slight R, 3=No Pref, 4=slight L, 5=strong L)|V1 (Initial), V2 (Day-7), V3 (Day-14), V4 (Day-30)|Not all subjects completed the study measures at each outcome measurement time frame before the study was terminated. 20 participants completed V1 and only 1 participant completed the V2 follow-up. V3 and V4 cannot be analyzed.||participants|||Number
695738|NCT01385995|Secondary|Mean and Standard Deviation of Insulin Sensitivity Index (ISI(0,120)) With Therapeutic CPAP vs. Sham|Insulin Sensitivity Index derived from the Gutt Index, uses the plasma glucose and insulin concentration from fasting (0 min) and 120-min samples from the OGTT, to calculate (Metabolic Clearance Rate)/log (Mean Serum Insulin). The range of possible values is based on the subset ranges of fasting and oral glucose tolerance test (OGTT) insulin and fasting and OGTT glucose, which calculate to be a range of 1.6 to 206.8. An increase in the ISI (0,120) indicates an improvement in the insulin sensitivity.|20 Weeks|||units on a scale||Standard Deviation|Mean
695739|NCT01385995|Secondary|Mean and Standard Deviation of Indices of Insulin Resistance With Therapeutic CPAP vs. Sham|Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) with therapeutic CPAP vs. Sham CPAP|20 weeks|All subjects with available fasting insulin, glucose measurements||percentage of beta cell function||Standard Deviation|Mean
695740|NCT01385995|Secondary|Mean and Standard Deviation of Insulin Indices After Therapeutic CPAP vs. Sham|The data for fasting and 2 hour Insulin (iIU/dL) are presented according to therapeutic CPAP vs. Sham CPAP.|20 weeks|All subjects with available fasting and and 2-hour insulin measurements are included.||iIU/dL||Standard Deviation|Mean
695741|NCT01385995|Secondary|Mean and Standard Deviation of Glucose Indices After Therapeutic CPAP vs. Sham|Reported values include: fasting glucose (mg/dL), 2 hour Oral Glucose Tolerance Test (OGTT) (mg/dL)|20 weeks|||mg/dL||Standard Deviation|Mean
695742|NCT01385995|Primary|Number of Subjects With Normalization of Impaired Glucose Tolerance (IGT)|Number of subjects who experienced normalization of the mean 2-hour oral glucose tolerance test (OGTT) in the overall sample undergoing therapeutic CPAP vs. sham CPAP. (2-hour OGTT glucose< 140 mg/dL)|20 weeks|All available oral glucose tolerance test data was analyzed for the total sample.||subjects|||Number
695743|NCT01385748|Other Pre-specified|Overall Treatment Compliance According to the Patient Diary|"All participants complete a daily questionnaire during the active phase (radiotherapy). Compliance = [ number of tablets / (end date of treatment - start date treatment + 1 ) ] * 100. The number of tablets is the number of days with a tablet applied and treatment start and end dates are the first and last dates of the patient diary with a tablet applied."|8 weeks|Participants with evaluable data.||percentage of compliance||Standard Deviation|Mean
695744|NCT01385748|Other Pre-specified|Salivary Flow Assessment Using the National Cancer Institute-Common Terminology Criteria (NCI-CTC) for Xerostomia: Time to First Grade 2 or Higher|Salivary flow was assessed and scored by the investigator weekly using the NCI-CTC scale for xerostomia for up to 8 weeks during the active phase (radiotherapy). Time to appearance of Grade 2 or higher on the following 4-point scoring scale is reported: 0 = normal; 1 = symptomatic (dry or thick saliva) without significant dietary alteration (unstimulated saliva flow greater than 0.2 mL/minute); 2 = symptomatic and significant oral intake alterations (e.g. copious water, other lubricants, diet limited to purees and/or soft, moist foods) (unstimulated saliva 0.1 to 0.2 mL/minute); and 3 = symptoms leading to inability to adequately aliment orally, intravenous fluids, tube feedings, or total parenteral nutrition indicated (unstimulated saliva < 0.1 mL/minute).|8 weeks|Two of the 183 participants received study treatment but withdrew early without any safety assessments (1 in the clonidine Lauriad 50 μg group and 1 in the clonidine Lauriad 100 μg group). The safety population therefore included 181 participants.||weeks||95% Confidence Interval|Median
695745|NCT01385748|Other Pre-specified|The Overall Incidence of Grade 3/4 Mucositis During the Active Phase.|The presence of grade 3 or 4 oral mucositis on the World Health Organization (WHO) oral mucositis severity scale was assessed twice weekly during the active phase (radiotherapy) by a trained radiation oncologist or an ear nose and throat specialist who took into account the field of radiation treatment. WHO score 3 = ulcers, extensive erythema, and the inability of the participant to swallow a solid diet; WHO score 4 = mucositis to the extent that alimentation was not possible.The number of participants with at least one Grade 3 or Grade 4 mucositis score during the active phase is reported.|8 weeks|Missing = participants without a WHO score during the active phase||participants|||Number
695746|NCT01385748|Other Pre-specified|The Maximum Severity of Oral Mucositis|Participants were assessed using the World Health Organization (WHO) oral mucositis severity scale twice weekly during the active phase (radiotherapy) by a trained radiation oncologist or an ear nose and throat specialist who took into account the field of radiation treatment. The WHO scores were as follows: 0 = None; 1 = oral soreness, erythema; 2 = oral erythema, ulcers, solid diet tolerated; 3 = oral ulcers, liquid diet only; 4 = oral alimentation impossible. The maximum severity was the maximum score reported during the active phase.|8 weeks|||participants|||Number
695747|NCT01385748|Other Pre-specified|Time to Onset of Severe Oral Mucositis|Time to onset is the duration until first Severe Oral Mucositis. Severe Oral Mucositis was defined as a Grade 3 or Grade 4 score on the World Health Organization (WHO) oral mucositis severity scale. Participants were assessed twice weekly during the active phase (radiotherapy) by a trained radiation oncologist or an ear nose and throat specialist who took into account the field of radiation treatment. WHO score 3 = ulcers, extensive erythema, and the inability of the participant to swallow a solid diet; WHO score 4 = mucositis to the extent that alimentation was not possible.|8 weeks|||weeks||95% Confidence Interval|Median
695748|NCT01385748|Secondary|Opioid Use: Minimal Total Cumulative Dose Administered (Median, Range)|Opioid use was recorded twice weekly for up to 8 weeks during the active phase (radiotherapy). The sum of non-missing total cumulative doses across all class 3 analgesics recorded for the considered participant is reported.|8 weeks|Participants with at least one use of an opioid during the active phase with evaluable data.||morphine dose equivalent||Full Range|Median
695749|NCT01385748|Secondary|Opioid Use: Minimal Total Cumulative Dose Administered (Mean, Standard Deviation)|Opioid use was recorded twice weekly for up to 8 weeks during the active phase (radiotherapy). The sum of non-missing total cumulative doses across all class 3 analgesics recorded for the considered participant is reported.|8 weeks|Participants with at least one use of an opioid during the active phase with evaluable data.||morphine dose equivalent||Standard Deviation|Mean
695750|NCT01385748|Secondary|At Least One Opioid Use (Class 3 Analgesic)|Opioid use was recorded twice weekly during the active phase (radiotherapy)|8 weeks|||participants|||Number
695751|NCT01385748|Primary|Cumulative Radiation Dose at Which Severe Oral Mucositis (World Health Organization [WHO] Score ≥ 3) Was First Observed|The primary endpoint planned in the protocol was the percentage of participants with an oral mucositis score greater than or equal to 3 using the WHO oral mucositis severity scale at a cumulative radiation dose of 50 Gy. This was modified by protocol amendment to the cumulative radiation dose at which a WHO score greater than or equal to 3 was first observed. This change was made to account for the fact that in real practice most patients receive a cumulative dose between 60 and 70 Gy. The presence of grade 3 or 4 oral mucositis was assessed twice weekly during the active phase (radiotherapy) by a trained radiation oncologist or an ear nose and throat specialist who took into account the field of radiation treatment. WHO score 3 = oral ulcers, liquid diet only; WHO score 4 = oral alimentation impossible. Each assessment was associated with the actual cumulative dose of radiotherapy.|8 weeks|The analysis was conducted on the Intent to treat population, defined as all participants who received at least one dose of investigational drug.||Cumulative radiation dose (Gy)||95% Confidence Interval|Median
695752|NCT01385696|Secondary|Percentage of Patients Making at Least 1 Critical Error Using the Genuair and Handihaler Devices at Visit 2|"The correct use of devices will be assessed measuring the errors made by patients when using each device after 2 weeks of daily practice (visit 2).
Critical error is defined as the one that compromise the potential benefit of the treatment such as those that impede drug deposition in the lungs or delivery of sufficient dose."|14 days|ITT: all randomized patients who used both devices at least once and expressed a preference for either or neither inhaler. 24 patients from the safety population (12 each arm) received the incorrect treatment allocation and were excluded from the ITT population. Missing data were handled via the observed cases approach.||Percentage of Patients|||Number
695753|NCT01385696|Secondary|Mean Overall Satisfaction With Genuair and Handihaler at Visit 2|The patient will be asked to rate the overall satisfaction with each device using a Likert-type scale (from 1 [very dissatisfied] to 5 [very satisfied]) after 2 weeks of daily practice (visit 2)|14 days|ITT: all randomized patients who used both devices at least once and expressed a preference for either or neither inhaler. 24 patients from the safety population (12 each arm) received the incorrect treatment allocation and were excluded from the ITT population. Missing data were handled via the observed cases approach.||Units on a scale (1-5)||95% Confidence Interval|Mean
695755|NCT01385644|Secondary|Percentage Change in Lung Function as Assessed by DLCO Compared to Baseline|DLCO was measured as a percentage of predicted, and the percentage change between 6 months post-infusion and baseline is reported.|6 months post MSC infusion|||percentage of baseline||Inter-Quartile Range|Median
695758|NCT01385644|Primary|Number of Participants Who Demonstrated Acute Adverse Events Following Infusion|Acute adverse events following infusion was defined as the development of anaphalaxis and/or a 25% increase or decrease from baseline of hemodynamic measurements.|4 hours post-infusion|Data from 8 participants was analyzed. (4 from each group)||participants|||Number
695759|NCT01385579|Primary|Completion of a Colorectal Cancer Screening|Patients who have documentation within the electronic health record of completion of a guideline approved form of colorectal cancer screening (colonoscopy, sigmoidoscopy, or fecal occult blood testing (FOBT)) within 4 months of the initiation of the outreach intervention (by June 30, 2010)|within 4 months of the initiation of outreach (by June 30, 2010)|||participants|||Number
695760|NCT01385566|Primary|Number of Participants Reporting a Non-injection-site Rash (Varicella, Varicella-like, Herpes Zoster, or Herpes Zoster-like)|Non-injection-site rashes were examined by a study physician. Rashes suspected to be varicella/varicella-like or herpes zoster/herpes zoster-like were sampled for verification by polymerase chain reaction.|Up to 42 days following vaccine administration|The population analyzed was all randomized participants who received study vaccination||participants|||Number
695761|NCT01385566|Primary|Number of Participants Reporting Systemic Adverse Experiences|Systemic AEs included all reported AEs except injection-site AEs|Up to 42 days following vaccine administration|The population analyzed was all randomized participants who received study vaccination||participants|||Number
695762|NCT01385566|Primary|Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC)|The VRC actively prompts for local injection-site AEs of redness, swelling, and pain/tenderness and for the size of local injection-site reactions of redness and swelling that occur within 5 days of vaccination. The presence of varicella/varicella-like rash and herpes zoster/herpes zoster-like rash is also captured on the VRC. Participants receiving an injection in both limbs will be instructed to complete injection-site reaction information for each limb. All injection-site AEs were reported for the limb in which they occurred: V211 vaccine or placebo.|Up to 5 days following vaccine administration|The population analyzed was all randomized participants who received study vaccination||Participants|||Number
695763|NCT01385566|Primary|Number of Participants Reporting a Serious Adverse Experience|An SAE is any adverse experience that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in or prolongs an existing inpatient hospitalization, is a congenital anomaly/birth defect in offspring of a study participant, is a cancer, or is another important medical event when, based on appropriate medical judgment, the event may jeopardize the participant and may require medical or surgical intervention|Within 5 days after the blood draw at approximately 20 months following vaccine administration|The population analyzed was all randomized participants who received study vaccination and had a Month 20 visit and follow-up||Participants|||Number
695764|NCT01385566|Primary|Number of Participants Reporting a Serious Adverse Experience (SAE)|An SAE is any adverse experience that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in or prolongs an existing inpatient hospitalization, is a congenital anomaly/birth defect in offspring of a study participant, is a cancer, or is another important medical event when, based on appropriate medical judgment, the event may jeopardize the participant and may require medical or surgical intervention.|Up to 42 days following vaccine administration|The population analyzed was all randomized participants who received study vaccination||participants|||Number
695765|NCT01385566|Primary|Number of Participants Reporting an Adverse Experience (AE)|"An AE is defined as any unfavorable and unintended change in the
structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse experience."|Up to 42 days following vaccine administration|The population analyzed was all randomized participants who received study vaccination||participants|||Number
695766|NCT01385566|Primary|Geometric Mean Fold Change From Baseline in Varicella Zoster Virus (VZV)-Specific Antibodies|VZV antibody titers were measured by glycoprotein enzyme-linked immunosorbent assay at baseline and at 6 weeks after vaccine administration. The geometric mean fold change represents the 6-week value / the baseline value.|Baseline and 6 weeks following vaccine administration|The population analyzed included participants who received vaccination and did not have any protocol deviations that may have interfered with the immune response.||Geometric mean fold change||90% Confidence Interval|Geometric Mean
695767|NCT01385371|Secondary|Average Paediatric Standardised Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Overall Score Over the Peak GPS (Participants 6 to <12 Years of Age)|For PRQLQ, participants assessed a total of 19 items within 5 domains: Nose Symptoms, Eye Symptoms, Practical Problems, Activity Limitation and Other Symptoms, each on a scale of 0 to 6 (0=Not troubled, 6=Extremely troubled; score range: 0 to 6 [mean of all domain scores]), with a higher score indicating more significant impairment due to seasonal allergic rhinoconjunctivitis.|Peak GPS (expected average duration of 2 weeks)|The FAS population consisted of all randomized participants <12 years of age who received at least one dose of study drug and had at least one post-treatment observation for the analysis endpoint.entry.||score on a scale||Full Range|Median
695768|NCT01385371|Secondary|Average Rhinoconjunctivitis DMS Over the Peak GPS|For rhinoconjunctivitis DMS, participants reported their use of specific rescue medications with specific scores assigned to each medication (score range: 0 to 36), with a lower score representing less use of medications for rhinoconjunctivitis.|Peak GPS (expected average duration of 2 weeks)|The FAS population consisted of all randomized participants who received at least one dose of study drug and had at least one post-treatment observation for the analysis endpoint.||score on a scale||Standard Error|Mean
695769|NCT01385371|Secondary|Average Rhinoconjunctivitis DSS Over the Peak GPS|For rhinoconjunctivitis DSS, participants assessed a total of 6 rhinoconjunctivitis symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes, and watery eyes) each on a scale of 0 to 3 (0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms; score range: 0 to 18), with a lower score representing less rhinoconjunctivitis symptoms.|Peak GPS (expected average duration of 2 weeks)|The FAS population consisted of all randomized participants who received at least one dose of study drug and had at least one post-treatment observation for the analysis endpoint.||score on a scale||Full Range|Median
701619|NCT00054717|Secondary|Median Change From Baseline in Viral Load to Week 2||Baseline to Week 2|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Log(Copies/mL)||Inter-Quartile Range|Median
695770|NCT01385371|Secondary|Average Rhinoconjunctivitis DMS Over the Entire GPS|For rhinoconjunctivitis DMS, participants reported their use of specific rescue medications with specific scores assigned to each medication (score range: 0 to 36), with a lower score representing less use of medications for rhinoconjunctivitis.|Entire GPS (expected average duration of 5 to 6 weeks)|The FAS population consisted of all randomized participants who received at least one dose of study drug and had at least one post-treatment observation for the analysis endpoint.||score on a scale||Standard Error|Mean
695771|NCT01385371|Secondary|Average Rhinoconjunctivitis Quality of Life Questionnaire With Standardized Activities for Participants ≥12 Years of Age (RQLQ12+) Over the Peak GPS|The RQLQ12+ consists of 7 domains: Activities, Sleep, Non-Nose/Eye Symptoms, Practical Problems, Nasal Symptoms, Eye Symptoms, Emotional. Participants reflect on their experience over the previous 7 days and assess 28 items on a scale of 0 to 6 (0=Not troubled, 6=Extremely troubled; score range: 0-6 [mean of all domain scores]), with a higher score indicating more significant impairment due to seasonal allergic rhinoconjunctivitis.|Peak GPS (expected average duration of 2 weeks)|The FAS population consisted of all randomized participants ≥12 years of age who received at least one dose of study drug and had at least one post-treatment observation for the analysis endpoint.||score on a scale||Full Range|Median
695772|NCT01385371|Secondary|Average Total Combined Rhinoconjunctivitis DSS and Rhinoconjunctivitis DMS Over the Peak GPS|"The total combined score was the sum of the rhinoconjunctivitis DSS and rhinoconjunctivitis DMS for the entire GPS (total score range: 0 to 54), with a lower score representing less rhinoconjunctivitis symptoms and use of medications.
For rhinoconjunctivitis DSS, participants assessed a total of 6 rhinoconjunctivitis symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes, and watery eyes) each on a scale of 0 to 3 (0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms; score range: 0 to 18), with a lower score representing less rhinoconjunctivitis symptoms.
For rhinoconjunctivitis DMS, participants reported their use of specific rescue medications with specific scores assigned to each medication (score range: 0 to 36), with a lower score representing less use of medications for rhinoconjunctivitis."|Peak GPS (expected average duration of 2 weeks)|The FAS population consisted of all randomized participants who received at least one dose of study drug and had at least one post-treatment observation for the analysis endpoint.||score on a scale||Full Range|Median
695773|NCT01385371|Secondary|Average Rhinoconjunctivitis DSS Over the Entire GPS|For rhinoconjunctivitis DSS, participants assessed a total of 6 rhinoconjunctivitis symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes, and watery eyes) each on a scale of 0 to 3 (0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms; score range: 0 to 18), with a lower score representing less rhinoconjunctivitis symptoms.|Entire GPS (expected average duration of 5 to 6 weeks)|The FAS population consisted of all randomized participants who received at least one dose of study drug and had at least one post-treatment observation for the analysis endpoint.||score on a scale||Full Range|Median
695774|NCT01385371|Primary|Average Total Combined Rhinoconjunctivitis Daily Symptom Score (DSS) and Rhinoconjunctivitis Daily Medication Score (DMS) Over the Entire Grass Pollen Season (GPS)|"The total combined score was the sum of the rhinoconjunctivitis DSS and rhinoconjunctivitis DMS for the entire GPS (total score range: 0 to 54), with a lower score representing less rhinoconjunctivitis symptoms and use of medications.
For rhinoconjunctivitis DSS, participants assessed a total of 6 rhinoconjunctivitis symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes, and watery eyes) each on a scale of 0 to 3 (0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms; score range: 0 to 18), with a lower score representing less rhinoconjunctivitis symptoms.
For rhinoconjunctivitis DMS, participants reported their use of specific rescue medications with specific scores assigned to each medication (score range: 0 to 36), with a lower score representing less use of medications for rhinoconjunctivitis."|Entire GPS (expected average duration of 5 to 6 weeks)|The Full Analysis Set (FAS) population consisted of all randomized participants who received at least one dose of study drug and had at least one post-treatment observation for the analysis endpoint.||score on a scale||Full Range|Median
695775|NCT01385293|Secondary|Time to New Metastatic Disease From the Baseline Visit|Time in days from the start of study treatment to time of new metastatic disease. Time to new metastatic disease is, defined from the date of first study agent administration to the onset of a new evaluable site of disease as per PCWG2 and RECIST 1.1 guidelines, excluding the primary site and all sites documented at baseline will be assessed. Only those patients that experienced a new lesion per this definition are included.|5 years|Only those patients that experienced a new lesion per this definition are included.||days||Full Range|Median
695776|NCT01385293|Secondary|Change in Circulating Tumor Cell (CTC) Levels From Baseline|The number of patients with a baseline CTC level of at least 5 who achieved a CTC level of less than 5 during the study.|2 years|13 patients had measured CTC levels above 5 at baseline||participants|||Number
695777|NCT01385293|Secondary|Overall Survival of Participants.|Time in months from the start of study treatment to date of death due to any cause. Patients alive as of the last follow-up had OS censored at the last follow-up date. Median OS was estimated using a Kaplan-Meier curve.|5 years|Intent to treat||months||95% Confidence Interval|Median
695778|NCT01385293|Secondary|Prostate Specific Antigen (PSA) Response|The number of patients with a 30% and 50% decrease in PSA from baseline.|2 years|Intent to treat||participants|||Number
695779|NCT01385293|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Number of patients experiencing grade 3-5 adverse events as defined by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0|Up to 28 days post last study drug dose. This is the follow-up safety visit.|Intent to treat||participants|||Number
695780|NCT01385293|Secondary|Radiologic Response|The number of patients achieving a complete response (CR) or partial response (PR) based on RECIST 1.1 criteria. Response and progression is evaluated using a combination of the Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) and the guidelines for prostate cancer endpoints developed by the Prostate Cancer Clinical Trials Working Group (PCWG2). Per RECIST, progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|2 years|Intent to treat||participants|||Number
695989|NCT01382251|Primary|Functional Autonomy Measurement System (SMAF)|29-item scale, each item graded on a four-point scale. 0= independent, 1= needs supervision,2 = needs help, 3 = dependent. Total score ranges from 0 to 87 with higher scores indicating increased disability|Baseline, one week, and one month following surgery|||units on a scale||Standard Deviation|Mean
695781|NCT01385293|Primary|Progression Free Survival (PFS) Prostate Cancer Working Group 2 (PCWG2) Criteria or Based on the Onset of a Skeletal Related Event.|"Time in months from the start of study treatment to the date of first progression or death due to any cause. Progression was determined either radiographically using a composite of the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and Prostate Cancer Working Group 2 (PCWG2) criteria or clinically as judged from a skeletal-related event, need for change in therapy, or clinical deterioration. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve.
Response and progression are evaluated using a combination of Response Evaluation Criteria in Solid Tumors (RECIST v1.1) and guidelines for prostate cancer endpoints developed by the Prostate Cancer Clinical Trials Working Group (PCWG2). Per RECIST, progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions."|5 years|Intent to treat||months||95% Confidence Interval|Median
695782|NCT01385202|Secondary|Rate of Acute Success|Acute success is defined as confirmation of entrance block in all Pulmonary veins (PV).|End of procedure|The analysis population for this endpoint includes two groups; a): Calibration Roll-in subjects who were prospectively identified prior to the study procedure and b) the Effectiveness Cohort. Both groups underwent an AF ablation procedure with the study catheter.||percentage of participants|||Number
695783|NCT01385202|Primary|Incidence of Early Onset (Within 7 Days of the AF Ablation Procedure) Primary Adverse Events.|Primary adverse events (AE) include Death, Myocardial infarction (MI), Pulmonary vein (PV) stenosis, Diaphragmatic paralysis, Atrio-esophageal fistula, Transient Ischemic Attack (TIA), Stroke / Cerebrovascular accident (CVA), Thromboembolism, Pericarditis, Cardiac Tamponade, Pericardial effusion, Pneumothorax, Atrial perforation, Vascular Access Complications, Pulmonary edema, Hospitalization (initial and prolonged), and Heart block.|7 days of the AF ablation procedure|Safety cohort includes all enrolled subjects who had the study catheter inserted.||Percentage of patients with primary AE||95% Confidence Interval|Number
695784|NCT01385202|Primary|The Rate of Subjects Who Were Free From Documented Symptomatic Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes Through 12-month Follow-up|The primary effectiveness endpoint for this study will be freedom from documented symptomatic atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) episodes through 12-month follow-up (includes a three month blanking period).|12-months|Primary Effectiveness Cohort includes those enrolled who met the inclusion/exclusion criteria and had undergone insertion of the study catheter and Atrial Fibrillation (AF) ablation procedure, excluding those with radiofrequency energy not delivered, with calibration roll-in, and with only non-study arrhythmia.||percentage of participants||95% Confidence Interval|Number
695785|NCT01385189|Secondary|IgG Antibody Response to Na-GST-1|Dose and formulation of Na-GST-1 that generates the highest IgG antibody response at Day 126, as determined by an indirect enzyme-linked immunosorbent assay (ELISA)|126 days post dose 1|||Arbitrary Units||Standard Deviation|Mean
695786|NCT01385189|Primary|Immediate Vaccine Related Adverse Events|Frequency of vaccine-related AEs, graded by severity, for each dose and formulation of Na-GST-1|2 hours post vaccination|||Participants|||Count of Participants
695787|NCT01385137|Secondary|Week 12 Functional Assessment of Cancer Therapy–Endocrine Symptoms (FACT-ES) Score|FACT-ES measures physical, social and family, emotional, and functional well-being and endocrine symptoms. The FACT scaleshave five response levels (“not at all” to “very much”), where higher scores reflect better well-being and fewer symptoms. This scale provided a measure of the broader impact of join pain and stiffness symptoms. Score range is 0 to 220.|12 weeks post-registration|||FACT-ES score||95% Confidence Interval|Mean
695788|NCT01385137|Secondary|Week 12 Modified Score for the Assessment and Quantification of Chronic Rheumatoid Affections of the Hands (M-SACRAH) Score|Linear regression model-adjusted week 12 mean score by treatment group. Higher scores represent higher symptom burden. Range is 0 to 100.|12 weeks post-registration|||M-SACRAH score||95% Confidence Interval|Mean
695789|NCT01385137|Secondary|Week 12 Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score|Linear regression model-adjusted week 12 mean score by treatment group The WOMAC measures five items for pain (score range 0–20), two for stiffness (score range 0–8), and 17 for functional limitation (score range 0–68). Higher scores indicate higher symptom burden.|12 weeks post-registration|||WOMAC score||95% Confidence Interval|Mean
695790|NCT01385137|Secondary|Number of Patients With Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Up to 25 weeks|All participants receiving at least some protocol treatment||Participants|||Number
695791|NCT01385137|Primary|Week 12 Brief Pain Inventory (BPI) Worst Pain/Stiffness Score|"Linear regression model-adjusted week 12 mean score by treatment group.
Purpose: To assess the severity of pain Population: Patients with pain from chronic diseases or conditions such as cancer, osteoarthritis and low back pain, or with pain from acute conditions such as postoperative pain Responsiveness: Responds to both behavioral and pharmacological pain interventions Method: Self-report or interview Scoring: Higher scores indicate more pain Range: 0-10"|12 weeks post-registration|||BPI score||95% Confidence Interval|Mean
695792|NCT01385033|Primary|Amyloid Plaque Burden Threshold Determined by the Trimmed HE Sample Mean and SD Brain Cortical [18F]MK-3328 SUVR|Using PET brain images acquired after dosing, ROIs are drawn in identified brain areas. ROIs are projected onto all frames of the dynamic PET scans in order to generate [18F]MK-3328 tissue TACs. SUVR is calculated as the ratio of the average [18F]MK-3328 uptake over 60-90 minutes post dose in the target brain region and the cerebellum. Cortical SUVR is determined, which is a mean SUVR derived from SUVR from multiple brain regions. The 1st and 2nd quartiles of the cortical SUVR distribution, Q1 and Q2, are computed for HE data; values with SUVR ≥(Q2-Q1)*3 are removed before calculation of HE mean (trimmed) and SD (trimmed). This step is performed to remove HE participants with positive plaque burden. Using HE data, the threshold for classification of plaque burden as positive/negative will be calculated as mean (trimmed) + k*SD (trimmed). Value of k will be chosen to fine tune sensitivity/specificity, with specificity of at least 0.9 in the sub-group remaining after trimming of data.|60-90 minutes post dose|The study was terminated early before completion of Part I. Given the low number of enrolled AD participants (6 of up to 15 planned in Part I), the interim analysis for futility in Part I was not conducted and the determination of an amyloid plaque burden threshold using PET imaging data obtained after [18F]MK-3328 administration was not performed.|||||
695793|NCT01385033|Primary|Brain Cortical [18F]MK-3328 SUVR in AD Participants and HE Participants|Using PET brain images acquired after dosing, ROIs are drawn in identified brain areas. The ROIs are projected onto all frames of the dynamic PET scans in order to generate [18F]MK-3328 tissue TACs. SUVR is calculated as the ratio of the average [18F]MK-3328 uptake over 60-90 minutes post dose in the target brain region and the cerebellum. Cortical SUVR is reported, which is a mean SUVR derived from SUVR from multiple brain regions (frontal cortex, parietal cortex, anterior cingulated gyrus, posterior cingulated gyrus, temporal cortex, lateral temporal cortex and occipital cortices). A trimming procedure will be applied to remove the sub-population of HE participants who have positive amyloid plaque burden. The 1st and 2nd quartiles of the cortical SUVR distribution, Q1 and Q2, are computed for HE data; values with SUVR ≥(Q2-Q1)*3 are removed before calculation of HE mean (trimmed) and standard deviation (SD)(trimmed).|60-90 minutes post dose|The study was terminated early before completion of Part I. Given the low number of enrolled AD participants (6 of up to 15 planned in Part I), the interim analysis for futility in Part I was not conducted and the determination of brain cortical [18F]MK-3328 SUVR values in AD and HE participants was not performed.|||||
695794|NCT01385033|Primary|Area Under the Receiver Operating Curve (AUC of ROC) for Distinguishing Between AD and HE Participants Based on Brain Cortical [18F]MK-3328 Standard Uptake Value Ratio (SUVR)|Using PET brain images acquired after dosing, regions of interest (ROIs) are drawn in identified brain areas. The ROIs are projected onto all frames of the dynamic PET scans in order to generate [18F]MK-3328 tissue time-activity curves (TACs). SUVR is calculated as the ratio of the average [18F]MK-3328 uptake over 60-90 minutes post dose in the target brain region and the cerebellum. Cortical SUVR is determined, which is a mean SUVR derived from SUVR from multiple brain regions (frontal cortex, parietal cortex, anterior cingulate gyrus, posterior cingulate gyrus, temporal cortex, lateral temporal cortex and occipital cortices). The receiver operating curve (ROC) for determining whether a participant is in HE or AD group by using cortical SUVR values is determined. The ROC is a plot of sensitivity on the y-axis versus 1-specificity (false positive rate) on the x-axis for the range of cortical SUVR threshold values. The AUC of ROC is determined.|60-90 minutes post dose|The study was terminated early before completion of Part I. Given the low number of enrolled AD participants (6 of up to 15 planned in Part I), the interim analysis for futility in Part I was not conducted and the potential of [18F]MK-3328 to distinguish between AD and HE participants was not assessed.|||||
695795|NCT01384760|Secondary|Epworth Sleepiness Score (ESS)|The Epworth Sleepiness Scale (ESS) is a questionnaire for assessing daytime sleepiness. It was first described in 1991 as a simple, self-administered questionnaire. The questionnaire is based on eight common situations in life. Subjects are asked to rate on a scale of 0-3 about how likely they would fall asleep or doze off in these circumstances. This gives a total score of 0 to 24 in each subject.The total score ranges from 0 to 24, with higher scores indicating higher sleepiness.|1 year|||units on a scale||Standard Deviation|Mean
695796|NCT01384760|Primary|Apnea-hypopnea Index (AHI) at One Year|AHI is a count of the number of upper airway obstruction per hour of sleep. The index will be derived from the overnight home sleep study.|1 year|||events per hour||Standard Deviation|Mean
695797|NCT01384539|Secondary|To Compare the Effect of Calcitriol and Cholecalciferol Supplementation on Vascular Endothelial Cell Expression of Nf-kB||6 months||||||
695798|NCT01384539|Secondary|To Compare the Efficacy of Calcitriol and Cholecalciferol Supplementation on Plasma Concentrations of C-reactive Protein|Secondary aims are focused to explore whether vitamin D improves vascular endothelial function through decreases in inflammation|6 months||||||
695799|NCT01384539|Primary|Difference Between the Calcitriol and Cholecalciferol Groups in Conduit Artery Endothelium-dependent Dilation (EDD) in Response to Treatment.|EDD measured by brachial artery flow-mediated dilation (FMD)|6 months|||% change in FMD from baseline||Standard Deviation|Mean
695800|NCT01384292|Primary|Response (Responder/Non-responder) to Study Drug|Response (responder/non-responder) to study drug, where a responder was defined as having at least 3 rescue-free bowel movements (RFBMs) per week during the 4-week Part A treatment period, with at least 1 RFBM per week increase over baseline for at least 3 out of 4 weeks. An RFBM was defined as a bowel movement (BM) without rescue laxatives in the previous 24 hours.|Baseline to Week 4|All randomized patients||Participants|||Number
695801|NCT01384019|Secondary|Reperfusion Success|microvascular obstruction, myocardial salvage, and infarct size measured using post-PCI CMR|3-5 days||||||
695802|NCT01384019|Primary|Postinfarct Remodeling|postinfarct remodeling as evidenced by decreased left ventricular (LV) dilatation measured by CMR 6 months post PCI|6 months|Forty one patients underwent 6 month CMR in distal protection group and 43 patients, in conventional PCI group.||Number of participants with remodeling|||Number
695803|NCT01383993|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration||Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing|The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.||hrs||Full Range|Median
695804|NCT01383993|Secondary|Maximum Observed Plasma Concentration at Steady State (Cmax,ss) of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration||Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing|The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
695805|NCT01383993|Secondary|Area Under the Plasma Concentration-time Profile From Time Zero to Twelve Hours at Steady-State (AUC12,ss) of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration|AUC12,ss was obtained by the Linear/Log trapezoidal method.|Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing|The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
695806|NCT01383993|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration||Day 7 (up to Day 20): predose, 1 hour after the start of infusion, 10-20 minutes after the end of infusion, and 4, 6, 8, and 12 hours after the start of infusion|The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.||hrs||Full Range|Median
695807|NCT01383993|Secondary|Maximum Observed Plasma Concentration at Steady State (Cmax,ss) of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration||Day 7 (up to Day 20): predose, 1 hour after the start of infusion, 10-20 minutes after the end of infusion, and 4, 6, 8, and 12 hours after the start of infusion|The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
695808|NCT01383993|Secondary|Area Under the Plasma Concentration-time Profile From Time Zero to Twelve Hours at Steady-State (AUC12,ss) of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration|AUC12,ss was obtained by the Linear/Log trapezoidal method.|Day 7 (up to Day 20): predose, 1 hour after the start of infusion, 10-20 minutes after the end of infusion, and 4, 6, 8, and 12 hours after the start of infusion|The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
695809|NCT01383993|Secondary|Ratio of AUC12,ss Following IV Administration Relative to AUC12,ss Following Oral Administration|Ratio was calculated from the following formula; AUC12,ss Following Oral Administration over AUC12,ss Following IV Administration|AUC12, ss for IV:Day 7 (up to Day 20): predose, 1 hour after the start of infusion, 10-20 minutes after the end of infusion. AUC12,ss for oral: Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing.|The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.||ratio||Standard Deviation|Mean
695810|NCT01383993|Primary|Number of Participants Assessed Visual Questionnaire||Screening, Day 7 (the 7th day of IV treatment), Day 8 (the 1st day of oral treatment), Day 14 (the 7th day of oral treatment), and the 30-day follow-up visit|The safety analysis was performed on all subjects who received at least 1 dose of study medication.||participants|||Number
695811|NCT01383993|Primary|Number of Participants Assessed Color Vision Test||Screening, Day 7 (the 7th day of IV treatment), Day 8 (the 1st day of oral treatment), Day 14 (the 7th day of oral treatment), and the 30-day follow-up visit|The safety analysis was performed on all subjects who received at least 1 dose of study medication.||participants|||Number
695812|NCT01383993|Primary|Number of Participants Assessed Near Distance Visual Acuity Test||Screening, Day 7 (the 7th day of IV treatment), Day 8 (the 1st day of oral treatment), Day 14 (the 7th day of oral treatment), and the 30-day follow-up visit|The safety analysis was performed on all subjects who received at least 1 dose of study medication.||participants|||Number
695813|NCT01383993|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) Following Oral Administration||Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing|The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.||hrs||Full Range|Median
695814|NCT01383993|Primary|Maximum Observed Plasma Concentration at Steady State (Cmax,ss) Following Oral Administration||Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing|The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
695815|NCT01383993|Primary|Area Under the Plasma Concentration-time Profile From Time Zero to Twelve Hours at Steady-State (AUC12,ss) Following Oral Administration|AUC12,ss was obtained by the Linear/Log trapezoidal method.|Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing|The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
695816|NCT01383993|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) Following IV Administration||Day 7 (up to Day 20): predose, 1 hour after the start of infusion, 10-20 minutes after the end of infusion, and 4, 6, 8, and 12 hours after the start of infusion|The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.||hrs||Full Range|Median
695817|NCT01383993|Primary|Maximum Observed Plasma Concentration at Steady State (Cmax,ss) Following IV Administration||Day 7 (up to Day 20): predose, 1 hour after the start of infusion, 10-20 minutes after the end of infusion, and 4, 6, 8, and 12 hours after the start of infusion|The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
695818|NCT01383993|Primary|Area Under the Plasma Concentration-time Profile From Time Zero to Twelve Hours at Steady-State (AUC12,ss) Following IV Administration|AUC12,ss was obtained by the Linear/Log trapezoidal method.|Day 7 (up to Day 20): predose, 1 hour after the start of infusion, 10-20 minutes after the end of infusion, and 4, 6, 8, and 12 hours after the start of infusion|The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
695819|NCT01383954|Primary|Percent Change From Baseline in Pain Score During Week 2|Participants assessed their knee pain using a visual analog scale (VAS) where 0=no pain and 100=worst possible pain. Pain scores were recorded in an electronic diary prior to and 4 hours after the first daily application of diclofenac gel for breakthrough pain. The daily percent change in pain scores over the 7 days prior to Week 2 were averaged. Percent change from baseline (average pain score 7 days prior to first treatment) was calculated as (value at baseline - value at post-baseline visit)/ (value at baseline) x 100. A positive change from baseline indicates improvement.|Baseline and Week 2|Modified Intent-to-Treat Population, all participants who completed at least 50% of the study (at least 2 weeks of drug treatment), who had pain data available for analysis at the given timepoints.||percent change||Standard Deviation|Mean
698610|NCT01353963|Primary|Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Week 8.||Week 8|Safety population included all participants who received at least 1 dose of study medication during the observation period.||millimeter of mercury (mmHg)||Standard Deviation|Mean
695820|NCT01383954|Primary|Percent Change From Baseline in Pain Score During Week 1|Participants assessed their knee pain using a visual analog scale (VAS) where 0=no pain and 100=worst possible pain. Pain scores were recorded in an electronic diary prior to and 4 hours after the first daily application of diclofenac gel for breakthrough pain. The daily percent change in pain scores over the 7 days prior to Week 1 were averaged. Percent change from Baseline (average pain score 7 days prior to first treatment) was calculated as (value at baseline - value at post-baseline visit) / (value at baseline) x 100. A positive change from Baseline indicates improvement.|Baseline and Week 1|Modified Intent-to-Treat Population, all participants who completed at least 50% of the study (at least 2 weeks of drug treatment), who had pain data available for analysis at the given timepoints.||percent change||Standard Deviation|Mean
697099|NCT01370408|Primary|Complete Response Rate for Delayed Chemotherapy Induced Nausea & Vomiting|Proportion of patients achieving a delayed CINV complete response (CR) defined as no emetic episode and no use of rescue medications during the 24-120 hour period post chemotherapy.|120 hours|||participants|||Number
708223|NCT00129246|Primary|Smoking Cessation|Smoking cessation is defined as the number of patients that displayed continuous 6-week abstinence from the quit date.|Week 6|Per protocol analysis||participants|||Number
698611|NCT01353963|Primary|Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Week 4.||Week 4|Safety population included all participants who received at least 1 dose of study medication during the observation period.||millimeter of mercury (mmHg)||Standard Deviation|Mean
695850|NCT01383720|Other Pre-specified|Acute Kidney Injury - Stage 2 or 3|"Stage 2: Increase in serum creatinine to 200-300% (2.0-3.0 times increase compared with baseline).
Stage 3: Increase in serum creatinine to ≥ 300% (> 3 times increase compared with baseline) or serum creatinine of ≥ 4.0 mg/d (≥ 354 μmol/L) with an acute increase of at least 0.5 mg/dl (44 μmol/L). Subjects receiving renal replacement therapy are considered to meet Stage 3 criteria irrespective of other criteria."|Discharge or 7 days post-procedure, whichever comes first|||participants|||Number
695851|NCT01383720|Other Pre-specified|Bleeding|"Life-threatening or Disabling Bleeding
Fatal bleeding OR
Bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, or pericardial necessitating pericardiocentesis, or intramuscular with compartment syndrome OR
Bleeding causing hypovolemic shock or severe hypotension requiring vasopressors or surgery OR
Overt source of bleeding with drop in hemoglobin of ≥5 g/dL or whole blood or packed red blood cells (RBC) transfusion ≥4 units
Major Bleeding
Overt bleeding either associated with a drop in the hemoglobin level of at least 3.0g/dL or requiring transfusion of 2 or 3 units of whole blood/RBC AND
Does not meet criteria of life-threatening or disabling bleeding"|Discharge or 7 days post-procedure, whichever comes first|||participants|||Number
695852|NCT01383720|Other Pre-specified|New Conduction Disturbances or Arrhythmias Requiring Permanent Pacemaker||Discharge or 7 days post-procedure, whichever comes first|||participants|||Number
695853|NCT01383720|Other Pre-specified|Major Vascular Complication|"Any thoracic aortic dissection
Access site or access-related vascular injury (dissection, stenosis, perforation, rupture, arterio-venous fistula, pseudoaneurysm, hematoma, irreversible nerve injury, or compartment syndrome) leading to either death, need for significant blood transfusions (≥4 units), unplanned percutaneous or surgical intervention, or irreversible end-organ damage (e.g. hypogastric artery occlusion causing visceral ischemia or spinal artery injury causing neurologic impairment)
Distal embolization (non-cerebral) from a vascular source requiring surgery or resulting in amputation or irreversible end-organ damage"|Discharge or 7 days post-procedure, whichever comes first|||participants|||Number
695854|NCT01383720|Other Pre-specified|Urgent/Emergent Conversion to Surgery or Repeat Procedure for Valve-related Dysfunction||Discharge or 7 days post-procedure, whichever comes first|||participants|||Number
695855|NCT01383720|Other Pre-specified|Major Stroke|Confirmed with a Modified Rankin score >/= 2 at 30 and 90 days|Discharge or 7 days post-procedure, whichever comes first|||participants|||Number
695856|NCT01383720|Other Pre-specified|Peri-procedural Myocardial Infarction|"Peri-Procedural Myocardial Infarction (≤72 hours after the index procedure)
New ischemic symptoms (e.g., chest pain or shortness of breath), or new ischemic signs (e.g. ventricular arrhythmias, new or worsening heart failure, new ST-segment changes, hemodynamic instability, or imaging evidence of new loss of viable myocardium or new wall motion abnormality), AND
Elevated cardiac biomarkers (preferably creatine kinase-myoglobin band) within 72 h after the index procedure, consisting of two or more post-procedure samples that are > 0.6 to 8 h apart with a 20% increase in the second sample and a peak value exceeding 10X the 99th percentile upper reference limit (URL), or a peak value exceeding 5X the 99th percentile URL with new pathological Q waves in at least 2 contiguous leads"|72 hours|||participants|||Number
695857|NCT01383720|Other Pre-specified|Death||Discharge or 7 days post-procedure, whichever comes first|||participants|||Number
695858|NCT01383720|Other Pre-specified|Aortic Valve Area|As determined by echocardiography|Discharge or 7 days post-procedure, whichever comes first|||cm^2||Standard Deviation|Mean
695859|NCT01383720|Other Pre-specified|Mean Aortic Valve Gradient|As determined by echocardiography|Discharge or 7 days post-procedure, whichever comes first|||mm Hg||Standard Deviation|Mean
695860|NCT01383720|Other Pre-specified|No Major Adverse Cardiovascular and Cerebrovascular Events Through Discharge|Major adverse cardiovascular or cerebrovascular events include all-cause mortality, periprocedural myocardial infarction ≤72 hours, major stroke, urgent/emergent conversion to surgery or repeat procedure for valve-related dysfunction|Discharge or 7 days post-procedure, whichever comes first|||participants|||Number
695861|NCT01383720|Other Pre-specified|Single Valve Implanted in the Proper Anatomical Location||procedure|||participants|||Number
695862|NCT01383720|Other Pre-specified|Intended Performance of the Lotus Valve|Aortic valve area >1.0 cm2 plus either a mean aortic valve gradient <20 mmHg or peak velocity <3m/sec, without moderate or severe prosthetic valve aortic regurgitation|At time of discharge or 7 days post procedure|||participants|||Number
695863|NCT01383720|Other Pre-specified|Successful Access, Device Delivery, Deployment and Positioning and Retrieval of Delivery System||Procedure|||participants|||Number
695864|NCT01383720|Secondary|Paravalvular Aortic Regurgitation|As determined by echocardiography|Discharge or 7 days post-procedure, whichever comes first|||participants|||Number
695865|NCT01383720|Secondary|Central Aortic Regurgitation|As determined by echocardiography|Discharge or 7 days post-procedure, whichever comes first|||participants|||Number
695866|NCT01383720|Secondary|Device Performance Endpoint-Valve Retrieval, if Attempted|Successful retrieval of the Lotus Valve System if retrieval is attempted|procedure|||participants|||Number
695867|NCT01383720|Secondary|Device Performance Endpoint-Repositioning|Successful repositioning of the Lotus Valve System if repositioning is attempted|procedure|Patients in whom repositioning of the Lotus Valve was attempted||participants|||Number
699443|NCT00004978|Secondary|Number of Participants With Changes in Anti-retroviral Treatment (ART)|Number of participants who changed ART at least once during the study period.|From randomization through study end - median of 7.6 years follow-up|||participants|||Number
695868|NCT01383720|Primary|Clinical Procedural Success|Clinical procedural success defined as successful implantation of a Lotus Valve System (Device Success) without in-hospital Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) through discharge or 7 days post-procedure, whichever comes first.|Discharge or 7 days post-procedure, whichever comes first|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis||participants|||Number
695869|NCT01383707|Secondary|Overall Survival (OS)|OS was defined as the time from the date of first study drug administration to the date of death due to any cause. Participants who were alive at the time of the analysis were censored at the last date the participant was known to be alive. OS was calculated as follows: OS (months) = ([Date of Death - first study drug administration] + 1)/30|End of study up to approximately 3 years|The ITT set, which included all enrolled participants, who received at least one dose of any study medication.||months||95% Confidence Interval|Median
695870|NCT01383707|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time from the date of first study drug administration to the date of disease progression or death due to any cause, whichever came first. Progression was defined according to RECIST, v1.1 as at least a 20% increase in the sum of diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions. Participants, who did not progress were censored at the date of the last assessment performed. Participants who withdrew from the study without documented progression and for whom an electronic case report form (eCRF) existed as evidence that evaluations had been made, were censored at the date of the last tumor assessment when the participant was known to be progression-free. Participants without post-baseline tumor assessments, but known to be alive were censored at the time of first study drug administration. PFS was calculated: PFS (months) = ([Date of Event - Date of first study drug administration] + 1)/30.|End of study up to approximately 3 years|The ITT set, which included all enrolled participants, who received at least one dose of any study medication.||months||95% Confidence Interval|Median
695871|NCT01383707|Secondary|Disease-free Interval (DFI)|DFI was defined as the time from the date of R0/R1 surgery to the date of disease relapse or death due to any cause. Participants who did not progress were considered censored at the date of the last assessment performed. For participants receiving two-stage resection, the date of R0/R1 surgery was the date of the second surgery. Participants, who did not receive surgery and participants without R0/R1 surgery were censored at Day 1. DFI was calculated as follows: DFI (months) = ([Date of R0/R1 surgery ‐ Date of 1st relapse/Death] + 1)/30|End of study up to approximately 3 years|The ITT set, which included all enrolled participants, who received at least one dose of any study medication.||months||95% Confidence Interval|Median
695872|NCT01383707|Secondary|Percentage of Participants Achieving No Residual Tumor (R0)/Surgical Margin With Microscopic Residual Tumor (R1) Liver Resection|The percentage of participants achieving R0/R1 liver resection was defined as the percentage of participants achieving R0 surgery (no residual tumor) plus percentage of participants achieving R1 surgery (surgical margin with microscopic residual tumor).|End of study up to approximately 3 years|The ITT set, which included all enrolled participants, who received at least one dose of any study medication.||percentage of participants||95% Confidence Interval|Number
695873|NCT01383707|Primary|Objective Response Rate (ORR) in the Per-protocol Analysis Set (PPAS)|ORR was defined as the percentage of participants with shrinkage (PR) or disappearance of cancer (CR). Tumor response was evaluated according to the RECIST v1.1. The same method of tumor measurement and assessment had to be used to characterize each lesion throughout the study. Tumor assessment consisted of CT scan (abdomen + pelvis + chest) or CE-MRI (abdomen + pelvis) + non CE-CT (chest) according to the choice of the center. CR, Disappearance of all target lesions; PR, >=30% decrease in the sum of the longest diameter of target lesions; OR = CR + PR.|Up to 11 cycles of treatment (up to Week 22)|The PPAS included all subjects in the ITT set, who did not experience any major protocol violations.||percentage of participants||95% Confidence Interval|Number
695874|NCT01383707|Primary|Objective Response Rate (ORR) in the Intent-to-treat (ITT) Analysis Set|ORR was defined as the percentage of participants with shrinkage (partial response [PR]) or disappearance of cancer (complete response [CR]). Tumor response was evaluated according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). The same method of tumor measurement and assessment had to be used to characterize each lesion throughout the study. Tumor assessment consisted of computerized tomography (CT) scan (abdomen + pelvis + chest) or contrast-enhanced magnetic resonance imaging (CE-MRI) (abdomen + pelvis) + non CE-CT (chest) according to the choice of the center. CR, Disappearance of all target lesions; PR, >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 11 cycles of treatment (up to Week 22)|The ITT set, which included all enrolled participants, who received at least one dose of any study medication.||percentage of participants||95% Confidence Interval|Number
695875|NCT01383681|Primary|Physician Assessment of Spasticity|The physician assessed spasticity as per local standard practice. Not enough data was collected for analysis of this outcome measure.|Month 12|Planned analysis: All participants. Not enough data was collected for analysis of this outcome measure.|||||
695876|NCT01383681|Primary|Physician Assessment of Spasticity|The physician assessed spasticity as per local standard practice. Not enough data was collected for analysis of this outcome measure.|Baseline|Planned analysis: All participants. Not enough data was collected for analysis of this outcome measure.|||||
695877|NCT01383616|Secondary|Middle Vertebral Body Height Restoration Following Surgery With Kyphoplasty|Preoperative and postoperative thoracolumbar radiographs were used to calculate the percent changes of the middle vertebral body heights.|Preoperative assessment within 3 weeks before surgery and postoperative day 1|Pre and postoperative measurements were available for 14 patients in the unipedicular group, and 17 patients in the bipedicular group.||percent change||Standard Deviation|Mean
695878|NCT01383616|Secondary|Comparison of 12 Month VAS Score Between Unipedicular and Bipedicular Kyphoplasty Groups|A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured.[1] It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. The scale is from 1-10 with 10 as the highest level of pain, and 0 being no pain|12 months post-op|From the period of intervention to 12 month follow-up, 9 total patients were lost in the unipedicular kyphoplasty arm, resulting in analysis of 14 patients from this arm at 12 months. 6 total patients were lost in the bipedicular kyphoplasty arm, resulting in analysis of 15 patients from this arm at 12 months.||units on a scale||Standard Deviation|Mean
695879|NCT01383616|Secondary|Comparison of 12 Month RDQ Score Between Unipedicular and Bipedicular Kyphoplasty Groups|The Roland Morris Disability Questionnaire is a widely used health status measure for low back pain. The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore vary from 0 to 24. It is not recommended to give patients a ‘Yes’ / ‘No’ option. If patients indicate in any way that an item is not applicable to them, the item is scored ‘No’, i.e. the denominator remains 24. A score of 0 indicates no back pain, while a score of 24 indicates significant back pain.|12 months post-op|From the period of intervention to 12 month follow-up, 9 total patients were lost in the unipedicular kyphoplasty arm, resulting in analysis of 14 patients from this arm at 12 months. 6 total patients were lost in the bipedicular kyphoplasty arm, resulting in analysis of 15 patients from this arm at 12 months.||units on a scale||Standard Deviation|Mean
695880|NCT01383616|Secondary|Comparison of 12 Month ODI Score Between Unipedicular and Bipedicular Kyphoplasty Groups|Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0–5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability.[2] The scores for all questions answered are summed. Zero is equated with no disability and 50 is the maximum disability possible|12 months post-op|From the period of intervention to 12 month follow-up, 9 total patients were lost in the unipedicular kyphoplasty arm, resulting in analysis of 14 patients from this arm at 12 months. 6 total patients were lost in the bipedicular kyphoplasty arm, resulting in analysis of 15 patients from this arm at 12 months.||units on a scale||Standard Deviation|Mean
695881|NCT01383616|Secondary|Comparison of 3 Month VAS Score Between Unipedicular and Bipedicular Kyphoplasty Groups|A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured.[1] It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. The scale is from 1-10 with 10 as the highest level of pain, and 0 being no pain|3 months post-op|From the period of intervention to 3 month follow-up, 5 patients were lost in the unipedicular kyphoplasty arm, resulting in analysis of 18 patients from this arm at 3 months. 3 patients were lost in the bipedicular kyphoplasty arm, resulting in analysis of 18 patients from this arm at 3 months.||units on a scale||Standard Deviation|Mean
695882|NCT01383616|Secondary|Comparison of 3 Month RDQ Score Between Unipedicular and Bipedicular Kyphoplasty Groups|The Roland Morris Disability Questionnaire is a widely used health status measure for low back pain. The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore vary from 0 to 24. It is not recommended to give patients a ‘Yes’ / ‘No’ option. If patients indicate in any way that an item is not applicable to them, the item is scored ‘No’, i.e. the denominator remains 24. A score of 0 indicates no low back pain, while a score of 24 indicates significant low back pain.|3 months post-op|From the period of intervention to 3 month follow-up, 5 patients were lost in the unipedicular kyphoplasty arm, resulting in analysis of 18 patients from this arm at 3 months. 3 patients were lost in the bipedicular kyphoplasty arm, resulting in analysis of 18 patients from this arm at 3 months.||units on a scale||Standard Deviation|Mean
695883|NCT01383616|Secondary|Measurement of Change in Kyphotic (Cobb) Angle Following Kyphoplasty|Preoperative and postoperative thoracolumbar radiographs used to calculate the change in kyphotic (Cobb) angle of the spine following surgery|Preoperative assessment within 3 weeks before surgery and postoperative day 1|Pre and postoperative measurements were available for 14 patients in the unipedicular group, and 17 patients in the bipedicular group.||percent change||Standard Deviation|Mean
695884|NCT01383616|Secondary|Anterior Vertebral Body Height Restoration Following Surgery With Kyphoplasty|Preoperative and postoperative thoracolumbar radiographs were used to calculate the percent changes of the anterior vertebral body heights.|Preoperative assessment within 3 weeks before surgery and postoperative day 1|Pre and postoperative measurements were available for 14 patients in the unipedicular group, and 17 patients in the bipedicular group.||percent change||Standard Deviation|Mean
695885|NCT01383616|Primary|Change in RDQ in the Bipedicular Group From 3 to 12 Months|The Roland Morris Disability Questionnaire is a widely used health status measure for low back pain. The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore vary from 0 to 24. It is not recommended to give patients a ‘Yes’ / ‘No’ option. If patients indicate in any way that an item is not applicable to them, the item is scored ‘No’, i.e. the denominator remains 24. A score of 0 indicates no low back pain, while a score of 24 indicates significant low back pain.|3-12 months post operation|From the period of intervention to 12 month follow-up, 6 total patients were lost in the bipedicular kyphoplasty arm, resulting in analysis of 15 patients from this arm at 12 months.||units on a scale||Standard Deviation|Mean
695886|NCT01383616|Primary|Comparison of 3 Month ODI Score Between Unipedicular and Bipedicular Kyphoplasty Groups|The Oswestry Disability Index (ODI) is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain. The self-completed questionnaire contains ten topics. Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0–5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.|Preoperative questionnaire within 3 weeks before surgery and postoperative questionnaires at 3 months after surgery|From the period of intervention to 3 month follow-up, 5 patients were lost in the unipedicular kyphoplasty arm, resulting in analysis of 18 patients from this arm at 3 months. 3 patients were lost in the bipedicular kyphoplasty arm, resulting in analysis of 18 patients from this arm at 3 months.||units on a scale||Standard Deviation|Mean
695901|NCT01383447|Secondary|Predictive Values of Levels of Flow Cytometric Minimal Residual Disease (MRD) on Duration of Progression Free Survival for the Study Population|Kaplan-Meier PFS curves and cumulative incidence of progression curves will be generated for patients above vs. below each threshold, and log rank will be used to compare the curves.|Day 29|This study was halted prematurely by the NCI for low accrual. No results were analyzed.|||||
695887|NCT01383499|Secondary|Change From Baseline in Mean Number of Nighttime Awakenings|Mean number of nighttime awakenings due to asthma symptoms as assessed by patients eDiary incorporated in the AM3® device. Analysis adjusted for treatment, period, patient and baseline using a mixed model. The scores for this question used the following scale where: 1='Did not wake up', 2='Woke up once', 3='Woke up 2-5 times', 4='Woke up more than 5 times' and 5='Was awake all night'.|Baseline and last week of treatment (week 4)|"FAS with at least one on-treatment value. For outcome measures obtained by AM3 device one patient in the TioR2.5 group had no on-treatment data."||scores on a scale||Standard Error|Least Squares Mean
695888|NCT01383499|Secondary|Control of Asthma as Assessed by Asthma Control Questionnaire (ACQ)|ACQ is a questionnaire consisting of seven point Likert scale ranging from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The scale describes the frequency and severity of asthma symptoms. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|4 weeks|FAS with at least one on-treatment value.||Score||Standard Error|Least Squares Mean
695889|NCT01383499|Secondary|Change From Baseline in the Number of Puffs of Rescue Medication Per Period (24 h, Daytime and Night-time Use)|Mean number of inhalations (puffs) of unscheduled rescue salbutamol therapy during whole day (24 h, daytime and night-time use). Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|"FAS with at least one on-treatment value. For outcome measures obtained by AM3 device one patient in the TioR2.5 group had no on-treatment data."||Puffs||Standard Error|Least Squares Mean
695890|NCT01383499|Secondary|Mean Evening PEF Response|Mean Evening PEF assessed by patients at home. Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|"FAS with at least one on-treatment value. For outcome measures obtained by AM3 device one patient in the TioR2.5 group had no on-treatment data."||Litre/min||Standard Error|Least Squares Mean
695891|NCT01383499|Secondary|Mean Morning Peak Expiratory Flow (PEF) Response|Mean morning PEF assessed by patients at home. Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|"FAS with at least one on-treatment value. For outcome measures obtained by AM3 device one patient in the TioR2.5 group had no on-treatment data."||Litre/min||Standard Error|Least Squares Mean
695892|NCT01383499|Secondary|FVC Area Under the Curve From 0 to 3 h (AUC0-3h) Response|FVC (AUC0-3h) will be calculated as the area under the curve from 0 to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|FAS with at least one on-treatment value.||Litre||Standard Error|Least Squares Mean
695893|NCT01383499|Secondary|FEV1 Area Under the Curve From 0 to 3 h (AUC0-3h) Response|FEV1 (AUC0-3h) will be calculated as the area under the curve from 0 to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|FAS with at least one on-treatment value.||Litre||Standard Error|Least Squares Mean
695894|NCT01383499|Secondary|FVC Trough Response|The trough FVC response is defined as the pre-dose FVC measured just prior to the last administration of randomised treatment. Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|FAS with at least one on-treatment value.||Litre||Standard Error|Least Squares Mean
695895|NCT01383499|Secondary|Forced Vital Capacity (FVC) Peak (0-3h) Response|The FVC peak (0-3h) response is determined at the end of the 4 week treatment period. This is the difference between the maximum FVC measured within the first 3 hours post dosing and the FVC baseline measurement. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|FAS with at least one on-treatment value.||Litre||Standard Error|Least Squares Mean
695896|NCT01383499|Secondary|Trough FEV1 Response|The trough FEV1 is defined as the pre-dose FEV1 measured just prior to the last administration of randomised treatment. Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|FAS with at least one on-treatment value.||Litre||Standard Error|Least Squares Mean
695897|NCT01383499|Primary|Forced Expiratory Volume (FEV1) Peak (0-3h) Response|The FEV1 peak (0-3h) response is determined at the end of the 4 week treatment period. This is the difference between the maximum FEV1 measured within the first 3 hours post dosing and the FEV1 baseline measurement. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|The Full analysis set (FAS) is defined as patients randomised, treated, with baseline data and at least one on-treatment efficacy measurement after 4 weeks on treatment within a period.||Litre||Standard Error|Least Squares Mean
695898|NCT01383486|Secondary|The Percentage of Low Literacy Participants Who Selected Naproxen Sodium ER and Expected Their Pain to Last More Than 12 Hours|In addition to the primary outcome measure evaluated for all selection evaluable participants, this secondary outcome was evaluated separately for low literacy participants. Low Literacy Participants are defined as those who had REALM (Rapid Estimate of Adult Literacy in Medicine) score </= 60 at visit 1.|Up to 14 days|Subgroup of Selection Evaluation Population: low literacy participants who had REALM score </= 60 at visit 1 and chose naproxen sodium.||Percentage of participants|||Number
695899|NCT01383486|Secondary|The Percentage of Participants Who Selected Naproxen Sodium ER , Expected Their Pain to Last More Than 12 Hours and Reported Their Selection Decision Within First 24 Hours||Within 24 hours of their selection decision taken up to 14 days|Subgroup of Selection Evaluation Population||Percentage of participants|||Number
695900|NCT01383486|Primary|The Percentage of Participants Who Selected Naproxen Sodium ER and Expected Their Pain to Last More Than 12 Hours|Participants were instructed to select a product for use upon their pain episode and then call a toll-free number for an interview within 30 minutes of the selection decision. Participants who did not call were interviewed after 14 days for data collection. The primary endpoint was derived from 2 variables: 1) number of participants who selected Naproxen Sodium ER and reported expected duration of pain less than or equal to 12 hrs (A); 2) number of participants who selected Naproxen Sodium ER and report expected duration of pain greater than 12 hrs (B). The results was calculated as B/(A+B).|up to 14 days|Only subjects who chose naproxen sodium were included in the analysis.||Percentage of participants|||Number
695902|NCT01383447|Secondary|Comparative Pharmacokinetics (PK) and Pharmacodynamics (PD) of Entinostat Alone vs. Entinostat Plus Imatinib Mesylate|Entinostat concentrations will be compared when administered alone or in combination with imatinib by paired Student’s t test (day 4 vs 11 concentrations) or Wilcoxon signed rank tests as appropriate. Association between exposure parameters and PD endpoints (e.g., apoptosis, histone acetylation, BCR-ABL expression) will be assessed using Fisher’s exact tests or Wilcoxon rank sum tests as appropriate.|Day 4 and 11|This study was halted prematurely by the NCI for low accrual. No results were analyzed.|||||
695903|NCT01383447|Secondary|Progression Free Survival (PFS) for Adults With Relapsed/Refractory Ph+ ALL Treated With Combination of Entinostat and Imatinib Mesylate|The Kaplan-Meier estimator will be used to estimate PFS with a 95% confidence interval from study entry.|At 1 year|This study was halted prematurely by the NCI for low accrual. No results were analyzed.|||||
695904|NCT01383447|Secondary|Rate of Complete Response (CR) for Adults With Relapsed/Refractory Ph+ ALL Treated With a Combination of Entinostat (at the Dose Determined in Phase 1) and Imatinib Mesylate||Up to 30 days post-treatment|This study was halted prematurely by the NCI for low accrual. No results were analyzed.|||||
695905|NCT01383447|Primary|Maximum Tolerated Dose (MTD) of Entinostat When Given in Combination With Imatinib Mesylate|The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.|Up to 30 days post-treatment|This study was halted prematurely by the NCI for low accrual. No results were analyzed.|||||
695906|NCT01383421|Other Pre-specified|PSP Satisfaction Questionnaire Responses at Week 78|The PSP satisfaction questionnaire evaluates the participant's satisfaction with specific PSP components as well as overall program satisfaction through the participant's selecting the response that best reflects their opinion: 1=very good; 2=good; 3=less satisfying; 4=I do not use the services. The percentage of participants at each response level per question is presented.|Week 78|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment. Observed cases.||percentage of participants|||Number
695907|NCT01383421|Other Pre-specified|PSP Satisfaction Questionnaire Responses at Week 52|The PSP satisfaction questionnaire evaluates the participant's satisfaction with specific PSP components as well as overall program satisfaction through the participant's selecting the response that best reflects their opinion: 1=very good; 2=good; 3=less satisfying; 4=I do not use the services. The percentage of participants at each response level per question is presented.|Week 52|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment. Observed cases.||percentage of participants|||Number
695908|NCT01383421|Other Pre-specified|PSP Satisfaction Questionnaire Responses at Week 24|The PSP satisfaction questionnaire evaluates the participant's satisfaction with specific PSP components as well as overall program satisfaction through the participant's selecting the response that best reflects their opinion: 1=very good; 2=good; 3=less satisfying; 4=I do not use the services. The percentage of participants at each response level per question is presented.|Week 24|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment. Observed cases.||percentage of participants|||Number
695909|NCT01383421|Other Pre-specified|PSP Satisfaction Questionnaire Responses at Week 12|The PSP satisfaction questionnaire evaluates the participant's satisfaction with specific PSP components as well as overall program satisfaction through the participant's selecting the response that best reflects their opinion: 1=very good; 2=good; 3=less satisfying; 4=I do not use the services. The percentage of participants at each response level per question is presented.|Week 12|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment. Observed cases.||percentage of participants|||Number
695910|NCT01383421|Other Pre-specified|Change From Baseline Means in the Beliefs About Medicines Questionnaire (BMQ) at Week 78|The BMQ consists of 11 questions used to assess the participant's beliefs about medication and the necessity of medications prescribed to them for rheumatoid arthritis. Each question answered from 'strongly disagree' to 'strongly agree,' with some questions attributed to the necessity sub-scale, and others to the concern sub-scale. Each answer is scaled from 1 to 5. The necessity sub-scale is calculated by taking the average of necessity scores, and the concern sub-scale is calculated by taking the average of the concern scores. Higher scores on the necessity sub-scale represent the stronger perceptions of the participant for the necessity of their medication. Similarly, higher scores on the concerns sub-scale represent stronger concerns about the potential negative effects of their medications.|Baseline, Week 78|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had non-missing Baseline and at least 1 non-missing post-Baseline value. Observed cases.||units on a scale||Standard Deviation|Mean
695911|NCT01383421|Other Pre-specified|Percentage of Participants Who Started at Level 3 (or Above) at Baseline and Remained at Level 3 or Improved to Level 4 on the PAM-13 at Week 78|The PAM-13 is a measure used to assess the participant's knowledge, skill, and confidence for self-management of his/her health. Participants are given a questionnaire of 13 statements to which they responded that they strongly disagree (1), disagree (2), agree (3), or strongly agree (4). Responses are summed and averaged to come up with an overall score of level 1 through level 4, with higher levels indicating more knowledge, skill and confidence for self-management.|Baseline, Week 78|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and were at Level 3 or 4 at Baseline. Non-responder imputation.||percentage of participants|||Number
695912|NCT01383421|Other Pre-specified|Percentage of Participants Who Started and Remained at Level 4 From Baseline to Week 78 on the PAM-13|The PAM-13 is a measure used to assess the participant's knowledge, skill, and confidence for self-management of his/her health. Participants are given a questionnaire of 13 statements to which they responded that they strongly disagree (1), disagree (2), agree (3), or strongly agree (4). Responses are summed and averaged to come up with an overall score of level 1 through level 4, with higher levels indicating more knowledge, skill and confidence for self-management.|Baseline, Week 78|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and were at Level 4 at Baseline. Non-responder imputation.||percentage of participants|||Number
696411|NCT01378429|Secondary|Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation.|Local Treatment-Emergent Adverse Events (ITT Population)|weeks 0-6|Intent-to-treat (ITT) Population: All randomized subjects who received at least 1 dose of double blind study medication.||percentage of participants|||Number
695913|NCT01383421|Other Pre-specified|Percentage of Participants Who Demonstrated Improvement From Baseline or Who Remained at Level 4 From Baseline on the Patient Activation Measure (PAM-13) at Week 78|The PAM-13 is a measure used to assess the participant's knowledge, skill, and confidence for self-management of his/her health. Participants are given a questionnaire of 13 statements to which they responded that they strongly disagree (1), disagree (2), agree (3), or strongly agree (4). Responses are summed and averaged to come up with an overall score of level 1 through level 4, with higher levels indicating more knowledge, skill and confidence for self-management.|Baseline, Week 78|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab. Non-responder imputation.||percentage of participants|||Number
695914|NCT01383421|Other Pre-specified|Mean Change From Baseline in Compliance Questionnaire Rheumatology (CQR) at Weeks 24, 52, and 78|"The CQR includes 19 items and measures RA treatment-specific compliance/adherence. Participants select an answer based on whether they agree with each statement. The agreements are based on a 4-point Likert scale with anchors don't agree at all (score = 1), don't agree (score = 2), agree (score = 3), and agree very much (score = 4). The total score is calculated by summing all 19 items and subtracting 19 from the total and dividing by 0.57. The compliance score ranges between 0 (complete non-compliance) to 100 (perfect compliance)."|Baseline, Week 24, 52, and 78|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment at given time point. Last observation carried forward.||units on a scale||Standard Deviation|Mean
695915|NCT01383421|Other Pre-specified|Mean Change From Baseline in TSQM Scores at Week 78|TSQM is a 14-point measure to show that adherence is expected to be related with participants' satisfaction with therapy and such satisfaction can be a function of not only the effect of the treatment, but also the services offered. TSQM responses are used to derive scores for scales measuring effectiveness, side effects, convenience, and global satisfaction (based on participant evaluation over the last 2 to 3 weeks, or since last medication use). Scores for each of the 4 scales range from 0 to 100 with higher scores indicating a better state or outcome (e.g., greater perceived effectiveness or satisfaction).|Baseline, Week 78|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment at given time point. Last observation carried forward.||units on a scale||Standard Deviation|Mean
695916|NCT01383421|Other Pre-specified|Mean Change From Baseline in TSQM Scores at Week 52|TSQM is a 14-point measure to show that adherence is expected to be related with participants' satisfaction with therapy and such satisfaction can be a function of not only the effect of the treatment, but also the services offered. TSQM responses are used to derive scores for scales measuring effectiveness, side effects, convenience, and global satisfaction (based on participant evaluation over the last 2 to 3 weeks, or since last medication use). Scores for each of the 4 scales range from 0 to 100 with higher scores indicating a better state or outcome (e.g., greater perceived effectiveness or satisfaction).|Baseline, Week 52|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment at given time point. Last observation carried forward.||units on a scale||Standard Deviation|Mean
695917|NCT01383421|Other Pre-specified|Mean Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Scores at Week 24|TSQM is a 14-point measure to show that adherence is expected to be related with participants' satisfaction with therapy and such satisfaction can be a function of not only the effect of the treatment, but also the services offered. TSQM responses are used to derive scores for scales measuring effectiveness, side effects, convenience, and global satisfaction (based on participant evaluation over the last 2 to 3 weeks, or since last medication use). Scores for each of the 4 scales range from 0 to 100 with higher scores indicating a better state or outcome (e.g., greater perceived effectiveness or satisfaction).|Baseline, Week 24|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment at given time point. Last observation carried forward.||units on a scale||Standard Deviation|Mean
695918|NCT01383421|Other Pre-specified|Mean Change From Baseline in WPAI at Week 78|"The WPAI assessed impact of RA on work productivity and non-work activity limitation. Participants were asked during the past 7 days: how many hours did you miss from work because of problems associated with RA (absenteeism), how many hours did you miss from work because of any other reason, such as vacation, holidays, time off to participate in this study (presenteeism), how much did your RA affect your productivity while you were working (overall work impairment), and much did RA affect your ability to do your regular daily activities, other than work at a job (activity impairment). Answers were rated on an 11-point scale, with 0 indicating RA had no effect on this and 10 indicating RA completely prevented me from this. A decrease in the WPAI score indicates improvement."|Baseline, Week 78|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment. Last observation carried forward.||units on a scale||Standard Deviation|Mean
695919|NCT01383421|Other Pre-specified|Mean Change From Baseline in WPAI at Week 52|"The WPAI assessed impact of RA on work productivity and non-work activity limitation. Participants were asked during the past 7 days: how many hours did you miss from work because of problems associated with RA (absenteeism), how many hours did you miss from work because of any other reason, such as vacation, holidays, time off to participate in this study (presenteeism), how much did your RA affect your productivity while you were working (overall work impairment), and much did RA affect your ability to do your regular daily activities, other than work at a job (activity impairment). Answers were rated on an 11-point scale, with 0 indicating RA had no effect on this and 10 indicating RA completely prevented me from this. A decrease in the WPAI score indicates improvement."|Baseline, Week 52|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment. Last observation carried forward.||units on a scale||Standard Deviation|Mean
695927|NCT01383421|Secondary|Percentage of Participants Achieving a MCID in the HAQ-DI at Week 64|The HAQ-DI is a self-reported assessment of how the participant's illness affects their ability to function in their daily life over the past week. The HAQ-DI for a participant is calculated as the mean of the following 8 category scores (range: 0 to 3): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. A lower score demonstrates less disability. The MCID in HAQ-DI was defined as an improvement of at least 0.22 in HAQ-DI compared to Baseline.|Baseline, Week 64|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab. Non-responder imputation.||percentage of participants||95% Confidence Interval|Number
695920|NCT01383421|Other Pre-specified|Mean Change From Baseline in Work Productivity and Activity Impairment (WPAI) at Week 24|"The WPAI assessed impact of RA on work productivity and non-work activity limitation. Participants were asked during the past 7 days: how many hours did you miss from work because of problems associated with RA (absenteeism), how many hours did you miss from work because of any other reason, such as vacation, holidays, time off to participate in this study (presenteeism), how much did your RA affect your productivity while you were working (overall work impairment), and much did RA affect your ability to do your regular daily activities, other than work at a job (activity impairment). Answers were rated on an 11-point scale, with 0 indicating RA had no effect on this and 10 indicating RA completely prevented me from this. A decrease in the WPAI score indicates improvement."|Baseline, Week 24|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment. Last observation carried forward.||units on a scale||Standard Deviation|Mean
695921|NCT01383421|Other Pre-specified|Percentage of Participants With a Good or Moderate EULAR Response (Using DAS28[CRP] at Week 78|"A EULAR response reflects improvement in disease activity and attainment of a lower degree of disease activity based on the DAS28(CRP) score. The DAS28(CRP) score ranges from 0-10, with higher scores indicating more disease activity.
A Good Response is defined as an improvement (decrease) in the DAS28 of >1.2 compared with Baseline and attainment of a DAS28 score of ≤ 3.2.
A Moderate Response is defined as either: an improvement (decrease) in the DAS28 of > 0.6 and ≤ 1.2 from Baseline and attainment of a DAS28 score of ≤ 5.1; or, an improvement (decrease) in the DAS28 of > 1.2 from Baseline and attainment of a DAS28 score of > 3.2.
No Response is defined as either an improvement (decrease) in the DAS28 of ≤ 0.6, or an improvement (decrease) in the DAS28 of > 0.6 and ≤ 1.2 and attainment of a DAS28 of > 5.1"|Week 78|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had non-missing visit values. Observed cases.||percentage of participants|||Number
695922|NCT01383421|Other Pre-specified|Percentage of Participants With a Good or Moderate European League Against Rheumatism (EULAR) Response (Using DAS28[ESR] at Week 78|"A EULAR response reflects improvement in disease activity and attainment of a lower degree of disease activity based on the DAS28(ESR) score. The DAS28(ESR) score ranges from 0-10, with higher scores indicating more disease activity.
A Good Response is defined as an improvement (decrease) in the DAS28 of > 1.2 compared with Baseline and attainment of a DAS28 score of ≤ 3.2.
A Moderate Response is defined as either: an improvement (decrease) in the DAS28 of > 0.6 and ≤ 1.2 from Baseline and attainment of a DAS28 score of ≤ 5.1; or, an improvement (decrease) in the DAS28 of > 1.2 from Baseline and attainment of a DAS28 score of > 3.2.
No Response is defined as either an improvement (decrease) in the DAS28 of ≤ 0.6, or an improvement (decrease) in the DAS28 of > 0.6 and ≤ 1.2 and attainment of a DAS28 of > 5.1"|Week 78|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had non-missing visit values. Observed cases.||percentage of participants|||Number
695923|NCT01383421|Other Pre-specified|Percentage of Participants Achieving American College of Rheumatology 20%, 50%, 70% (ACR20, ACR50, ACR70) Response at Week 78|"ACR20/50/70 response is a 20%/50%/70% improvement in a participant's disease condition compared to Baseline. A participant is considered an ACR20/50/70 responder if the following 3 criteria are met: ≥ 20/50/70% improvement in 28 tender joint count; ≥ 20/50/70% improvement in swollen joint count; ≥ 20/50/70% improvement in at least 3 of the following 5 assessments:
Patient's assessment of pain
Patient's global assessment of disease activity
Physician's global assessment of disease activity
HAQ-DI
Acute phase reactant value (CRP or erythrocyte sedimentation date [ESR])"|Week 78|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had non-missing visit values. Observed cases.||percentage of participants|||Number
695924|NCT01383421|Other Pre-specified|Mean Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 24, 52, and 78|The CDAI is a validated measure of RA disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global health assessed by the participant on a visual analogue scale from 0 to 10 (cm), and global health assessed by an investigator on a visual analogue scale from 0 to 10 (cm) were included in the CDAI score. Scores on the CDAI range from 0 to 76. A CDAI score ≥22.1 indicates high disease activity, a CDAI score between 10.1 and 22.0 indicates moderate disease activity, a CDAI score between 2.9 and 10.0 indicates low disease activity, and a CDAI score ≤2.8 indicates clinical remission.|Baseline, Weeks 24, 52, and 78|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment at given time point. Last observation carried forward.||units on a scale||Standard Deviation|Mean
695925|NCT01383421|Other Pre-specified|Mean Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 24, 52, and 78|The SDAI is a validated measure of RA disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global disease activity assessed by the participant on a visual analogue scale from 0 to 10 (cm) , global disease activity assessed by an investigator on a visual analogue scale from 0 to 10 (cm), and serum levels of C-reactive protein (mg/dL) were included in the SDAI score. Scores on the SDAI range from 0 to 86. An SDAI score ≥26.1 indicates high disease activity, an SDAI score between 11.1 and 26.0 indicates moderate disease activity, an SDAI score between 3.4 and 11.0 indicates low disease activity, and an SDAI score ≤3.3 indicates clinical remission.|Baseline, Weeks 24, 52, and 78|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment at given time point. Last observation carried forward.||units on a scale||Standard Deviation|Mean
695926|NCT01383421|Other Pre-specified|Mean Change From Baseline in With 28-Joint Disease Activity Score of C-reactive Protein (DAS28[CRP]) at Weeks 24, 52, and 78|The DAS28 is a validated combined index of RA disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher numbers indicating more disease activity.|Baseline and Weeks 24, 52, 78|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment at given time point. Last observation carried forward.||units on a scale||Standard Deviation|Mean
695982|NCT01382303|Secondary|Mean Change of Creatinine|changes serum creatinine from baseline to 24 weeks|baseline and 24 weeks|||mg/dL||Standard Deviation|Mean
695983|NCT01382303|Secondary|Mean Change of eGFR|changes in eGFR from baseline to 24 weeks|baseline and 24 weeks|||ml/min per 1.73m2||Standard Deviation|Mean
695984|NCT01382303|Secondary|Percentage Change in Albuminuria|Changes of urine albumin to creatinie ratio from baseline to 24 weeks|baseline and 24 weeks|||% change from baseline||Inter-Quartile Range|Mean
695928|NCT01383421|Secondary|Percentage of Participants Achieving a MCID in the HAQ-DI at Week 52|The HAQ-DI is a self-reported assessment of how the participant's illness affects their ability to function in their daily life over the past week. The HAQ-DI for a participant is calculated as the mean of the following 8 category scores (range: 0 to 3): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. A lower score demonstrates less disability. The MCID in HAQ-DI was defined as an improvement of at least 0.22 in HAQ-DI compared to Baseline.|Baseline, Week 52|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab. Non-responder imputation.||percentage of participants||95% Confidence Interval|Number
695929|NCT01383421|Secondary|Percentage of Participants Achieving a MCID in the HAQ-DI at Week 36|The HAQ-DI is a self-reported assessment of how the participant's illness affects their ability to function in their daily life over the past week. The HAQ-DI for a participant is calculated as the mean of the following 8 category scores (range: 0 to 3): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. A lower score demonstrates less disability. The MCID in HAQ-DI was defined as an improvement of at least 0.22 in HAQ-DI compared to Baseline.|Baseline, Week 36|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab. Non-responder imputation.||percentage of participants||95% Confidence Interval|Number
695930|NCT01383421|Secondary|Percentage of Participants Achieving a MCID in the HAQ-DI at Week 24|The HAQ-DI is a self-reported assessment of how the participant's illness affects their ability to function in their daily life over the past week. The HAQ-DI for a participant is calculated as the mean of the following 8 category scores (range: 0 to 3): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. A lower score demonstrates less disability. The MCID in HAQ-DI was defined as an improvement of at least 0.22 in HAQ-DI compared to Baseline.|Baseline, Week 24|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab. Non-responder imputation.||percentage of participants||95% Confidence Interval|Number
695931|NCT01383421|Secondary|Percentage of Participants Achieving a MCID in the HAQ-DI at Week 12|The HAQ-DI is a self-reported assessment of how the participant's illness affects their ability to function in their daily life over the past week. The HAQ-DI for a participant is calculated as the mean of the following 8 category scores (range: 0 to 3): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. A lower score demonstrates less disability. The MCID in HAQ-DI was defined as an improvement of at least 0.22 in HAQ-DI compared to Baseline.|Baseline, Week 12|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab. Non-responder imputation.||percentage of participants||95% Confidence Interval|Number
695932|NCT01383421|Primary|Percentage of Participants Achieving a Minimal Clinically Important Difference (MCID) in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 78|The HAQ-DI is a self-reported assessment of how the participant's illness affects their ability to function in their daily life over the past week. The HAQ-DI for a participant is calculated as the mean of the following 8 category scores (range: 0 to 3): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. A lower score demonstrates less disability. The MCID in HAQ-DI was defined as an improvement of at least 0.22 in HAQ-DI compared to Baseline.|Baseline, Week 78|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab. Non-responder imputation.||percentage of participants|||Number
695933|NCT01383356|Secondary|Area Under the Curve 0 to Inf (AUC0-inf)|AUC0-inf is the area under the concentration versus time curve of metformin in plasma from time zero extrapolated to infinity.|Prior to drug administration and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 30, and 36 hours post dose in each treatment period|All subjects having all samples in all periods and subjects who missed samples that may not affect the estimation of pharmacokinetic parameters in any period||ng*h/ml||Standard Deviation|Mean
695934|NCT01383356|Primary|Area Under the Curve 0 to Last Measurable Value (AUC0-t)|AUC0-t is the area under the concentration versus time curve of metformin in plasma, from time zero (0) to the time of the last measurable analyte concentration (t), as calculated by the linear trapezoidal method.|Prior to drug administration and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 30, and 36 hours post dose in each treatment period|All subjects having all samples in all periods and subjects who missed samples that may not affect the estimation of pharmacokinetic parameters in any period||ng*h/ml||Standard Deviation|Mean
695935|NCT01383356|Primary|Maximum Plasma Concentration (Cmax)|Maximum measured concentration of metformin in plasma, per period.|Prior to drug administration and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 30, and 36 hours post dose in each treatment period|All subjects having all samples in all periods and subjects who missed samples that may not affect the estimation of pharmacokinetic parameters in any period.||ng/ml||Standard Deviation|Mean
695936|NCT01383213|Secondary|to Compare the Efficacy of the Two Treatments in Terms of In-hospital Mortality|"The secondary endpoint of this study will be evaluated, if appropriate, on 3 subpopulations composed of:
CPAP: patients randomised to CPAP treatment who have changed treatment only after the reaching of the primary endpoint
Control: patients randomised to Venturi mask treatment
Mixed: patients who, after the treatment with Venturi mask, have needed to be treated with non-invasive CPAP"|participants will be followed for the duration of hospital stay, an expected average of 4 weeks||||||
695937|NCT01383213|Primary|to Evaluate the Efficacy of CPAP (Group A) in Comparison With Oxygen Therapy With Venturi Mask (Group B, Standard Therapy) in Terms of Achievement of Criteria for Endotracheal Intubation.|"Endotracheale intubation criteria:≥1 among the major criteria or ≥2 among the minor criteria MAJOR CRITERIA:Respiratory arrest;Respiratory pauses with unconsciousness;Severe hemodynamic instability; Need of sedation MINOR CRITERIA:Reduction ≥ 30% of basal PaO2/FiO2; Increasing of 20% PaCO2 if basal PaCO2 is≥40mmHg; Worsening of alertness;Distress;SpO2<90%;Exhaustion.
The reaching of these criteria does not automatically imply the actual intubation of the patient, since this decision will depend on the treating physician."|the reaching of the following endotracheal intubation criteria maintained for at least one hour:|||participants|||Number
695938|NCT01383200|Primary|Participants Score on Pain Scale|Do you have sharp pain in your eye? Pain will be assessed by units on a scale of 1-5: 1 means no symptoms, 2 means slight discomfort, 3 means mild discomfort, 4 means moderate discomfort, and 5 means severe discomfort|1 hour (60minutes) post LASIK operation|Five participants received tetracaine right eye and lidocaine left eye and six participants received lidocaine right eye and tetracaine left eye. A total of 22 eyes were analyzed for pain.||Score on scale|eyes|Standard Deviation|Mean
695939|NCT01383174|Secondary|Breast Cancer-Specific Distress of the Intrusive Thoughts Scale|Breast cancer-specific distress was measured with the 7 item Intrusive Thoughts Scale (anchored to the breast cancer experience), a subscale of the revised Impact of Event Scale (RIES). Response options were 0=not at all, 1=rarely, 2=sometimes, and 3=often. Using the published scoring algorithm, items were summed after recoding responses to 0, 1, 3, and 5. Possible score ranges were 0-35. Higher scores indicate greater distress.|Baseline and 6 month assessment|Using intention-to-treat analyses, used repeated-measures linear regression models to estimate the intervention effects on outcomes. Likelihood-based model estimation assumed outcome responses were missing at random.||units on a scale||Standard Deviation|Mean
695940|NCT01383174|Secondary|Somatization a Subscale of the Brief Symptom Inventory (BSI)|BSI was used to measure general symptoms of distress. BSI consists of 3 scale scores pertaining to general symptoms of distress (anxiety, depression, somatization). Response options were 0=not at all, 1=a little bit, 2=moderately, 3=quite a bit, and 4=extremely. Scores were the mean of nonmissing items. Possible score ranges for somatization were 0-4. Higher scores indicated more distress.|Baseline and 6 month assessment|Using intention-to-treat analyses, used repeated-measures linear regression models to estimate the intervention effects on outcomes. Likelihood-based model estimation assumed outcome responses were missing at random.||units on a scale||Standard Deviation|Mean
695941|NCT01383174|Secondary|Depression a Subscale of the Brief Symptom Inventory (BSI)|BSI was used to measure general symptoms of distress. BSI consists of 3 scale scores pertaining to general symptoms of distress (anxiety, depression, somatization). Response options were 0=not at all, 1=a little bit, 2=moderately, 3=quite a bit, and 4=extremely. Scores were the mean of nonmissing items. Possible score ranges for depression were 0-4. Higher scores indicated more distress.|Baseline and 6 month assessment|Using intention-to-treat analyses, used repeated-measures linear regression models to estimate the intervention effects on outcomes. Likelihood-based model estimation assumed outcome responses were missing at random.||units on a scale||Standard Deviation|Mean
695942|NCT01383174|Primary|Total Score of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)|"FACT-B was used as the breast cancer–specific quality-of-life measure. FACT-B consists of 5 subscale scores pertaining to 4 well-being dimensions (physical, social–family, emotional, functional) and additional breast cancer concerns. A total overall score is the sum of all subscales. Response options were 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much.
Psychometric analysis in our Spanish-speaking Latina sample resulted in modifications to each of the FACT-B subscale. The total overall score is based on the sum of modified subscales (see above primary outcomes for modifications to subscales). Possible score ranges for the total overall score were 0–108. Higher scores indicated greater well-being."|Baseline and 6 month assessment|Using intention-to-treat analyses, used repeated-measures linear regression models to estimate the intervention effects on outcomes. Likelihood-based model estimation assumed outcome responses were missing at random.||units on a scale||Standard Deviation|Mean
695943|NCT01383174|Primary|Enjoyment of Life a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)|"FACT-B was used as the breast cancer–specific quality-of-life measure. FACT-B consists of 5 subscale scores pertaining to 4 well-being dimensions (physical, social–family, emotional, functional) and additional breast cancer concerns. A total overall score is the sum of all subscales. Response options were 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much.
Psychometric analysis in our Spanish-speaking Latina sample resulted in modifications to FACT-B: functional well-being subscale. Of 7 items, 3 were dropped because items were conceptually different and did not converge psychometrically with the other items on that scale; the remaining 4 items were specific to enjoyment of life, thus we renamed the subscale to Enjoyment of Life. Modified subscale was scored by summing items. Possible score ranges for enjoyment of life were 0–16. Higher scores indicated greater well-being."|Baseline and 6 month assessment|Using intention-to-treat analyses, used repeated-measures linear regression models to estimate the intervention effects on outcomes. Likelihood-based model estimation assumed outcome responses were missing at random.||units on a scale||Standard Deviation|Mean
695944|NCT01383174|Primary|Breast Cancer Concerns a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)|"FACT-B was used as the breast cancer–specific quality-of-life measure. FACT-B consists of 5 subscale scores pertaining to 4 well-being dimensions (physical, social–family, emotional, functional) and additional breast cancer concerns. A total overall score is the sum of all subscales. Response options were 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much.
Psychometric analysis in our Spanish-speaking Latina sample resulted in modifications to FACT-B: breast cancer concerns subscale. Of 7 items, 2 were dropped because of low item-scale correlations and were conceptually different from the other items on that scale. Modified subscale was scored by summing items. Possible score ranges for emotional well-being were 0–28. Higher scores indicated greater well-being."|Baseline and 6 month assessment|Using intention-to-treat analyses, used repeated-measures linear regression models to estimate the intervention effects on outcomes. Likelihood-based model estimation assumed outcome responses were missing at random.||units on a scale||Standard Deviation|Mean
695945|NCT01383174|Primary|Emotional Well-being a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)|"FACT-B was used as the breast cancer–specific quality-of-life measure. FACT-B consists of 5 subscale scores pertaining to 4 well-being dimensions (physical, social–family, emotional, functional) and additional breast cancer concerns. A total overall score is the sum of all subscales. Response options were 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much.
Psychometric analysis in our Spanish-speaking Latina sample resulted in modifications to FACT-B: emotional well-being subscale. Of 6 items, 1 was dropped because of low item-scale correlations and it was conceptually different from the other items on that scale (only positively worded item on the scale). Modified subscale was scored by summing items. Possible score ranges for emotional well-being were 0–20. Higher scores indicated greater well-being."|Baseline and 6 month assessment|Using intention-to-treat analyses, used repeated-measures linear regression models to estimate the intervention effects on outcomes. Likelihood-based model estimation assumed outcome responses were missing at random.||units on a scale||Standard Deviation|Mean
695985|NCT01382303|Primary|Percentage Change in Proteinuia|Changes of urine protein to creatinie ratio from baseline to 24 weeks|baseline and 24 weeks|||% change from baseline||Inter-Quartile Range|Mean
709759|NCT00150969|Secondary|Effect of Vitamin K1 Supplementation on Level of Bone Resorption Markers (C-telopeptide: CTX)|measured by CTX Elisa assay on elecsys platform|0-24 months|||ng/ml||Standard Deviation|Mean
695946|NCT01383174|Primary|Social/Family Well-being a Subcale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)|"FACT-B was used as the breast cancer–specific quality-of-life measure. FACT-B consists of 5 subscale scores pertaining to 4 well-being dimensions (physical, social–family, emotional, functional) and additional breast cancer concerns. A total overall score is the sum of all subscales. Response options were 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much.
Psychometric analysis in our Spanish-speaking Latina sample resulted in modifications to FACT-B: social/family well-being subscale. Of 7 items, 2 were dropped because the items were conditional on having a partner (resulting in lots of missing data). Modified subscale was scored by summing items. Possible score ranges for social/family well-being were 0–20. Higher scores indicated greater well-being."|Baseline and 6 month assessment|Using intention-to-treat analyses, used repeated-measures linear regression models to estimate the intervention effects on outcomes. Likelihood-based model estimation assumed outcome responses were missing at random.||units on a scale||Standard Deviation|Mean
695947|NCT01383174|Secondary|Anxiety a Subscale of the Brief Symptom Inventory (BSI)|BSI was used to measure general symptoms of distress. BSI consists of 3 scale scores pertaining to general symptoms of distress (anxiety, depression, somatization). Response options were 0=not at all, 1=a little bit, 2=moderately, 3=quite a bit, and 4=extremely. Scores were the mean of nonmissing items. Possible score ranges for anxiety were 0-4. Higher scores indicated more distress.|Baseline and 6 month assessment|Using intention-to-treat analyses, used repeated-measures linear regression models to estimate the intervention effects on outcomes. Likelihood-based model estimation assumed outcome responses were missing at random.||units on a scale||Standard Deviation|Mean
695948|NCT01383174|Primary|Physical Well-being a Subcale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)|"FACT-B was used as the breast cancer–specific quality-of-life measure. FACT-B consists of 5 subscale scores pertaining to 4 well-being dimensions (physical, social–family, emotional, functional) and additional breast cancer concerns. A total overall score is the sum of all subscales. Response options were 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much.
Psychometric analysis in our Spanish-speaking Latina sample resulted in modifications to FACT-B: physical well-being subscale. Of 7 items, 1 was dropped because it was conceptually different from other items on that scale. Modified subscale was scored by summing items. Possible score ranges for physical well-being were 0–24. Higher scores indicated greater well-being."|Baseline and 6 month assessment|Using intention-to-treat analyses, used repeated-measures linear regression models to estimate the intervention effects on outcomes. Likelihood-based model estimation assumed outcome responses were missing at random.||units on a scale||Standard Deviation|Mean
695949|NCT01383096|Primary|OZ439 t1/2|Apparent terminal half life (t1/2)|1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post dosing|Pharmacokinetic Population: all subjects who received study drug, and completed at least one treatment (provided they had adequate OZ439 plasma concentration data) were included in the pharmacokinetic analysis.||hours||Geometric Coefficient of Variation|Geometric Mean
695950|NCT01383096|Primary|OZ439 AUC0-∞|Area under the plasma concentration-time curve from zero to infinity (AUC0-∞)|1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post dosing|Pharmacokinetic Population: all subjects who received study drug, and completed at least one treatment (provided they had adequate OZ439 plasma concentration data) were included in the pharmacokinetic analysis.||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
695951|NCT01383096|Primary|OZ439 Cmax|The maximum observed plasma drug concentrations (Cmax)|1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post dosing|Pharmacokinetic Population: all subjects who received study drug, and completed at least one treatment (provided they had adequate OZ439 plasma concentration data) were included in the pharmacokinetic analysis.||ng/ml||Geometric Coefficient of Variation|Geometric Mean
695952|NCT01383005|Secondary|Percentage of Participants With Missing Doses During “the Past 4 Days” and “the Last Weekend” in KAPITAL-2 and QD-KAPITAL Studies|Adherence to LPV/r QD therapy (overall study population of QD-KAPITAL) compared with that of LPV/r BID therapy using data of Cohort 2 from a 2007-2008 study, respectively (KAPITAL2, Casado et al. See Detailed Description for full reference). The KAPITAL2 cohort was comprised of HIV-infected participants treated with LPV/r BID from ≥3 months to <2 years for at least 1 month before inclusion in the study. (A full comparison of the adherence between the QD-KAPITAL study and the KAPITAL2 study could not be made due to formal differences in the applied adherence questionnaires; therefore, the above in-common specified item was compared.) Data for the overall study population of QD-KAPITAL are provided here, but a comparison to Cohort 2 from the KAPITAL2 study is not presented.|at the single study visit, performed after at least 12 weeks of treatment with Kaletra|All participants with evaluable data.||percentage of participants|||Number
695953|NCT01383005|Secondary|Comparison of Mean Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Dimension Scores From QD-KAPITAL and KAPITAL2 Studies|Participants' perceptions of the QD and BID LPV/r regimens using data from the overall study population of QD-KAPITAL and from Cohort 2 of a 2007-2008 study, respectively (KAPITAL2, Casado et al. See Detailed Description for full reference). The KAPITAL2 cohort was comprised of HIV-infected participants treated with LPV/r BID from ≥3 months to <2 years for at least 1 month before inclusion in the study. Data for the overall study population of QD-KAPITAL are provided here, but a comparison to Cohort 2 from the KAPITAL2 study is not presented.|at the single study visit, performed after at least 12 weeks of treatment with Kaletra|All participants with evaluable data. n=the number of participants with data for given dimension.||units on a scale||Standard Deviation|Mean
695954|NCT01383005|Secondary|Mean Number of Days on LPV/r QD|This independent variable was correlated with the percentage of participants with the dependent variable of an HIVTSQ Overall Satisfaction dimension mean score value of <5 (see Outcome Measure 8), to determine the factors associated with a participant's lower perception of QD LPV/r treatment (see statistical analysis for odds ratio).|At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD|All participants, per responses to the HIVTSQ Overall Satisfaction Dimension||days||Standard Deviation|Mean
695986|NCT01382251|Secondary|Brief Pain Inventory (BPI) Functional Interference Score.|Comprised of seven questions in which the subject is asked to describe the extent to which pain interferes with activity. Scores are anchored at 0 for “does not interfere” and 10 for “completely interferes.” The seven resulting scores are averaged and reported as a single value (0 - 10) with higher scores indicating greater interference with function.|Baseline, one week, and one month following surgery|||units on a scale||Standard Deviation|Mean
695955|NCT01383005|Secondary|Viral Load (VL) Change After at Least 12 Weeks of Treatment With the Lopinavir/Ritonavir (LPV/r)|Viral load change was categorized as either 'detectable to undetectable,' 'undetectable to undetectable,' or 'current detectable' (includes participants whose viral load changed from undetectable to detectable and those whose viral load was detectable throughout). This independent variable was correlated with the percentage of participants with the dependent variable of a Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Overall Satisfaction dimension mean score value of <5 (see Outcome Measure 8), to determine the factors associated with a participant's lower perception of QD LPV/r treatment (see statistical analyses for odds ratio).|At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD|All participants, per responses to the HIVTSQ Overall Satisfaction Dimension||participants|||Number
695956|NCT01383005|Secondary|Percentage of Participants With a Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Overall Satisfaction Dimension Mean Score Value of ≥5 and <5|The HIVTSQ consists of 10 items (1-Satisfaction, 2-HIV Control, 3-Adverse Effects, 4-Level of Demand, 5-Convenience, 6-Flexibility, 7-Knowledge, 8-Life Habits, 9-Recommendability, and 10-Willingness to Continue). Items are scored from 0 (very dissatisfied) to 6 (very satisfied), other than item 4, which has an inverted score from 6 (very demanding) to 0 (very undemanding). The items are aggregated to 3 different dimensions. The Overall Satisfaction dimension has a maximum score of 54 (items 1, 2, 3, 5, 6, 7, 8, 9 and 10). The mean of the individual item scores were dichotomized as 'mean score <5 (lower participant perception of LPV/r QD)' and 'mean score ≥5 (high or very high participant perception of LPV/r QD).' The dependent variable of a mean score <5 was correlated with the independent variables of viral load and time on treatment (see Outcome Measures 9 and 10), to determine the factors associated with a participant's lower perception of QD LPV/r treatment.|At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD|All participants||percentage of participants|||Number
695957|NCT01383005|Secondary|Reasons for Starting or Switching to a Lopinavir/Ritonavir Once Daily (LPV/r QD)Regimen|Participants’ cumulative reasons for starting or switching to a LPV/r QD regimen were tabulated via the following yes/no questions entered on the case report form by the physician: simplification (simp) as reason to change to LPV/r QD; preference (pref) of patient as reason to change to LPV/r QD; adjustment to other antiretrovirals (adjust to ARV) as reason to change to LPV/r QD; adherence as reason to change to LPV/r QD; patient’s lifestyle as reason to change to LPV/r QD; tolerability as reason to change to LPV/r QD.|At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD|All participants||participants|||Number
695958|NCT01383005|Secondary|Adherence Classification of Participants Per Simplified Medication Adherence Questionnaire (SMAQ)|Participants' adherence was classified according to answers for 5 of 6 items on the participant questionnaire Simplified Medication Adherence Questionnaire (SMAQ): 4 yes/no questions: Do you ever forget to take your medicines? Do you take your medicines at the instructed time? If you ever feel ill, do you stop taking the medication? Have you ever missed your medication during weekends?; plus the following: In the past week, how many times have you missed your medication? (0, 1-2, 3-5, 6-10, >10). (Please see Outcome Measure 5 for details regarding the 6th item on the SMAQ.) Perfect adherence = no dose was forgotten, medication was not skipped for any reason, and the schedule was not modified; adequate adherence = no dose was forgotten, but at least one dose was not taken at the indicated time; poor adherence = one or more doses were not taken.|At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD|All participants with complete data.||participants|||Number
695959|NCT01383005|Secondary|Number of Days Without Medication, Per Simplified Medication Adherence Questionnaire (SMAQ)|Number of days without medication was assessed by 1 of the 6 items on the patient questionnaire Simplified Medication Adherence Questionnaire (SMAQ): How many full days have you missed your medication since your last visit? (Please see Outcome Measure 6 for details regarding the remaining 5 items on the SMAQ.)|At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD|All participants with complete data.||participants|||Number
695960|NCT01383005|Secondary|Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Dimension (Overall Satisfaction, General/Clinical Satisfaction, Lifestyle) Scores Comparison Between Cohorts|The HIVTSQ consists of 10 items (1-Satisfaction, 2-HIV Control, 3-Adverse Effects, 4-Level of Demand, 5-Convenience, 6-Flexibility, 7-Knowledge, 8-Life Habits, 9-Recommendability, and 10-Willingness to Continue). Items are scored from 0 (very dissatisfied) to 6 (very satisfied), other than item 4, which has an inverted score from 6 (very demanding) to 0 (very undemanding). The items are aggregated to 3 different dimensions: the Overall Satisfaction dimension, with a maximum score of 54 (items 1, 2, 3, 5, 6, 7, 8, 9 and 10); General/Clinical Satisfaction dimension, with a maximum score of 30 (items 1, 2, 3, 9 and 10); Lifestyle dimension, with a maximum score of 24 (items 5, 6, 7 and 8). The mean score per dimension was compared between cohorts.|At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD|All participants with complete data. n=number of participants with complete data for given HIVTSQ item.||units on a scale||Standard Deviation|Mean
695961|NCT01383005|Primary|Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ)Dimension (Overall Satisfaction, General/Clinical Satisfaction, Lifestyle) Scores for the Overall Study Population|The HIVTSQ consists of 10 items (1-Satisfaction, 2-HIV Control, 3-Adverse Effects, 4-Level of Demand, 5-Convenience, 6-Flexibility, 7-Knowledge, 8-Life Habits, 9-Recommendability, and 10-Willingness to Continue). Items are scored from 0 (very dissatisfied) to 6 (very satisfied), other than item 4, which has an inverted score from 6 (very demanding) to 0 (very undemanding). The items are aggregated to 3 different dimensions: the Overall Satisfaction dimension, with a maximum score of 54 (items 1, 2, 3, 5, 6, 7, 8, 9 and 10); General/Clinical Satisfaction dimension, with a maximum score of 30 (items 1, 2, 3, 9 and 10); Lifestyle dimension, with a maximum score of 24 (items 5, 6, 7 and 8). Each dimension was considered for the evaluation of the primary outcome. For each participant, each dimension score was calculated as a sum of the individual item scores.|At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD|All participants with complete data. n=number of participants with complete data for given HIVTSQ item.||units on a scale||Standard Deviation|Mean
695987|NCT01382251|Secondary|Short Form 12|A validated measure of health related quality of life comprised of 12 questions regarding participant experience over the preceding week. Generate Physical And Mental Component scores ranging from 0-100 with higher scores indicating better quality of life.|Baseline, one week, and one month following surgery|||units on a scale||Standard Deviation|Mean
695962|NCT01383005|Secondary|Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Individual Item Scores Comparison Between Cohorts|The HIVTSQ consists of 10 items (1-Satisfaction, 2-HIV Control, 3-Adverse Effects, 4-Level of Demand, 5-Convenience, 6-Flexibility, 7-Knowledge, 8-Life Habits, 9-Recommendability, and 10-Willingness to Continue). Items are scored from 0 (very dissatisfied) to 6 (very satisfied), other than item 4, which has an inverted score from 6 (very demanding) to 0 (very undemanding). The mean score per item was compared between cohorts.|At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD|All participants with complete data. n=number of participants with complete data for given HIVTSQ item.||units on a scale||Standard Deviation|Mean
695963|NCT01383005|Primary|Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Individual Item Scores for the Overall Study Population|Participant treatment satisfaction was measured using the HIVTSQ, which consists of 10 items (1-Satisfaction, 2-HIV Control, 3-Adverse Effects, 4-Level of Demand, 5-Convenience, 6-Flexibility, 7-Knowledge, 8-Life Habits, 9-Recommendability, and 10-Willingness to Continue). Items are scored from 0 (very dissatisfied) to 6 (very satisfied), other than item 4, which has an inverted score from 6 (very demanding) to 0 (very undemanding). Each single item was considered for the evaluation of the primary outcome.|At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD|All participants with complete data. n=number of participants with complete data for given HIVTSQ item.||units on a scale||Standard Deviation|Mean
695964|NCT01382940|Secondary|Percentage of Participants Experiencing the Stopping, Slowing or Interrupting of the Third Rituximab Infusion|"Participants who experienced a moderate or serious IRR had their infusion interrupted immediately and received aggressive symptomatic treatment. The CTCAE includes the following severity descriptions: - “Moderate” means mild to moderate interference with the patient’s daily activities, no or minimal medical intervention/therapy required; - Severe means considerable interference with the patient's daily activities, medical intervention/therapy required, hospitalization possible. If the IRR was moderate, the infusion was not to be restarted before all the symptoms disappeared, and then at half the rate. If the participant tolerated the reduced rate for 30 minutes, the infusion rate was increased to the next rate on the protocol-specified infusion schedule. If the symptoms did not resolve with treatment, the participant was withdrawn from the treatment period of the study. Participants who experienced a severe IRR to rituximab treatment were discontinued from the study."|During the infusion (a 2-hour period) on Day 168|All randomized participants who received infusion at the faster rate on Day 168. One participant received the Day 168 rituximab infusion at the labeled rate rather than at the faster rate and was excluded from the analysis population.||percentage of participants||95% Confidence Interval|Number
695965|NCT01382940|Secondary|Percentage of Participants Experiencing Any Common Toxicity Criteria (CTC) Grade 3 or 4 Adverse Events (AEs) Associated With the Third Rituximab Infusion|"The intensity of AEs experienced within 24 hours of beginning infusion were graded on NCI's CTCAE (v. 4.0) intensity scale from Grade 1 (Mild) to Grade 5 (Death). Grade 3 AEs are Severe and Grade 4 AEs are Life-threatening, Disabling."|Within 24 hours of beginning infusion on Day 168|All randomized participants who received infusion at the faster rate on Day 168. One participant received the Day 168 rituximab infusion at the labeled rate rather than at the faster rate and was excluded from the analysis population.||percentage of participants||95% Confidence Interval|Number
695966|NCT01382940|Secondary|Percentage of Participants Experiencing the Stopping, Slowing or Interrupting of the Second Rituximab Infusion|"Participants who experienced a moderate or serious IRR had their infusion interrupted immediately and received aggressive symptomatic treatment. The CTCAE includes the following severity descriptions: - “Moderate” means mild to moderate interference with the patient’s daily activities, no or minimal medical intervention/therapy required; - Severe means considerable interference with the patient's daily activities, medical intervention/therapy required, hospitalization possible. If the IRR was moderate, the infusion was not to be restarted before all the symptoms disappeared, and then at half the rate. If the participant tolerated the reduced rate for 30 minutes, the infusion rate was increased to the next rate on the protocol-specified infusion schedule. If the symptoms did not resolve with treatment, the participant was withdrawn from the treatment period of the study. Participants who experienced a severe IRR to rituximab treatment were discontinued from the study."|During the infusion (a 2-hour period) on Day 15|All randomized participants who received infusion at the faster rate on Day 15. Four participants who received the Day 15 rituximab infusion were excluded from the primary analysis population because their infusion rates could not be determined.||percentage of participants||95% Confidence Interval|Number
695967|NCT01382940|Secondary|Percentage of Participants Experiencing Any Common Toxicity Criteria (CTC) Grade 3 or 4 Adverse Events (AEs) Associated With the Second Rituximab Infusion|"The intensity of AEs were graded on a 5-point scale (Grade 1 to 5) according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v. 4.0), where Grade 1 indicates Mild severity and Grade 5 indicates Death. The CTCAE defines Grades 3 and 4 as follows: - Grade 3 means Severe, indicating considerable interference with the patient's daily activities; medical intervention/therapy required; and hospitalization possible. - Grade 4 means Life-threatening, Disabling, based on extreme limitation in activity; significant medical intervention/therapy required, and hospitalization probable."|Within 24 hours of beginning infusion on Day 15|All randomized participants who received infusion at the faster rate on Day 15. Four participants who received the Day 15 rituximab infusion were excluded from the primary analysis population because their infusion rates could not be determined.||percentage of participants||95% Confidence Interval|Number
695968|NCT01382940|Secondary|Percentage of Participants Experiencing Any IRR or SIRR Associated With the Third Rituximab Infusion|IRRs are AEs that occurred within 24 hours of beginning infusion that were included on a pre-specified list of MedDRA preferred terms, and an SIRR is an IRR that suggests a significant hazard, contraindication, side effect or precaution.|Within 24 hours of beginning infusion on Day 168|All randomized participants who received infusion at the faster rate on Day 168. One participant received the Day 168 rituximab infusion at the labeled rate rather than at the faster rate and was excluded from the analysis population.||percentage of participants||95% Confidence Interval|Number
695988|NCT01382251|Secondary|Zarit Burden Interview (ZBI)|"A 22-item questionnaire in which subjects rate how often they experience negative feelings associated with caregiving. Each item rated on a 5 point scale anchored at 0 for never and 4 for nearly always. Scores range from 0-88 with higher scores indicating increased burden of care."|Baseline, one week, and one month following surgery|||units on a scale||Standard Deviation|Mean
695969|NCT01382940|Secondary|Percentage of Participants Experiencing Any Serious IRR (SIRR) Associated With the Second Rituximab Infusion|A serious infusion-related reaction (SIRR) is an IRR that meets the definition of a serious adverse event. A serious adverse event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution.|Within 24 hours of beginning infusion on Day 15|All randomized participants who received infusion at the faster rate on Day 15. Four participants who received the Day 15 rituximab infusion were excluded from the primary analysis population because their infusion rates could not be determined.||percentage of participants||95% Confidence Interval|Number
695970|NCT01382940|Primary|Percentage of Participants Experiencing Any Infusion-related Reaction (IRR) Associated With the Second Rituximab Infusion|"The primary criterion for assessing safety of the faster infusion was the incidence of infusion related reaction (IRRs). IRRs were adverse events (AEs) that occurred within 24 hours of beginning infusion that were among a pre-specified list of preferred terms from the Medical Dictionary for Regulatory Activities (MedDRA). Incidence is defined as the percentage of participants experiencing an IRR."|Within 24 hours of beginning infusion on Day 15|All randomized participants who received infusion at the faster rate on Day 15. Four participants who received the Day 15 rituximab infusion were excluded from the primary analysis population because their infusion rates could not be determined.||percentage of participants||95% Confidence Interval|Number
695971|NCT01382901|Primary|International Restless Legs Syndrome (IRLS) Total Score|The scale represents the patients symptoms of RLS. The patient rates his/her symptoms based on 10 questions with a maximum possible score of 40 representing the most severe symptoms while a score of 0 represents no symptoms at all.|Change from Baseline to Day 28|Evaluable Population||Scores on a scale||Standard Deviation|Mean
695972|NCT01382719|Secondary|FSDS–DAO Total Score|"FSDS-DAO (Female Sexual Distress Scale - Desire/Arousal/Orgasm) is an assessment tool to measure female sexual distress. The change from baseline to end of study in the FSDS-DAO (total score) was measured. There are 15 questions, eg, How often do you feel: Distressed about your sex life and the score range was 0 (Never), 1 (Rarely), 2 (Occasionally), 3 (Frequently), 4 (Always). The score for each subject at each time point was computed as the sum of the scores from the 15 questions, resulting in a possible score at each time point between 0 and 60."|4 - 12 weeks from baseline to end of study (total study duration 20 weeks)|||units on a scale||Standard Deviation|Mean
695973|NCT01382719|Secondary|Quality of Relationship With Partner as Measured by GAQ Question 4|"This is the change in Baseline to End-of-Study in Quality of Relationship with Partner as Measured by GAQ Question 4. GAQ (Global Assessment Questions) is a questionnaire that evaluates overall satisfaction level experienced while using the study drug. Question 4 is Compared to the start of the study (prior to taking the study drug), how has taking the study drug changed your relationship with your partner? The score range is 1 (very much worse) to 7 (very much better)."|4-12 weeks from baseline to end of study (total study duration 20 weeks)|||units on a scale||Standard Deviation|Mean
695974|NCT01382719|Secondary|Satisfaction With Desire as Measured by GAQ Question 2|"This is the change in Baseline to End-of-Study in Satisfaction with Desire as Measured by GAQ Question 2. GAQ (Global Assessment Questions) is a questionnaire that evaluates overall satisfaction level experienced while using the study drug. Question 2 is Compared to the start of the study (prior to taking the study drug), how would you describe your satisfaction with your desire while using the study drug? The score range is 1 (very much worse) to 7 (very much better)."|4-12 weeks from baseline to end of study (total study duration 20 weeks)|||units on a scale||Standard Deviation|Mean
695975|NCT01382719|Secondary|Desire Domain From Female Sexual Function Index|The FSFI is brief self-report questionnaire that measures female sexual function. The change from baseline to end of study in the desire domain were obtained from the FSFI Q1 and Q2. The score range is 1-5. For each of the 2 time points, the score was computed programmatically using the algorithm described by Rosen [6], resulting in a score from 0 (min) to 6 (max).|4-12 weeks from baseline to end of study (total study duration 20 weeks)|||units on a scale||Standard Deviation|Mean
695976|NCT01382719|Secondary|Satisfaction With Arousal as Measured by GAQ Question 1|"This is the change in Baseline to End-of-Study in Satisfaction with Arousal as measured by GAQ Question 1. GAQ (Global Assessment Questions) is a questionnaire that evaluates overall satisfaction level experienced while using the study drug. Question 1 is Compared to the start of the study (prior to taking the study drug), how would you describe your satisfaction with your arousal while using the study drug? The score range is 1 (very much worse) to 7 (very much better)."|4-12 weeks from baseline to end of study (total study duration 20 weeks)|||units on a scale||Standard Deviation|Mean
695977|NCT01382719|Secondary|Change From Baseline to End-of-Study in Arousal Domain Score From Female Sexual Function Index|The FSFI is brief self-report questionnaire that measures female sexual function. The change from baseline to end of study in the arousal domain were obtained from the FSFI Q3 through Q6. The score range is 0-5. For each of the 2 time points, the score was computed programmatically using the algorithm described by Rosen [6], resulting in a score from 0 (min) to 6 (max).|4-12 weeks from baseline to end of study (total study duration 20 weeks)|||units on a scale||Standard Deviation|Mean
695978|NCT01382719|Primary|The Primary Efficacy Endpoint is Change From Baseline to End of Study in the Number of Satisfying Sexual Events (SSE)|"The primary efficacy endpoint is change from baseline to end of study in the number of satisfying sexual events (SSEs), computed as the number of events during the last 4 weeks of treatment with FSEP-R Q10 = Yes minus the number of baseline events with FSEP-R Q10 = Yes. Efficacy analyses were done with the MITT population which consisted of all randomized subjects who took at least 1 dose of double-blind treatment after the 2 in-clinic doses of double-blind medication and who had at least 1 follow-up visit (Visit 10 or later) to ensure that FSEP-R data were reviewed and confirmed by the investigative site."|4 - 12 weeks from baseline to end of study (total study duration 20 weeks). Baseline was the 4-week single-blind placebo period.|||SSEs||Standard Deviation|Mean
695979|NCT01382446|Primary|Effectiveness of Chlorhexidine Gluconate Oral Care for Trauma Patients|Examination of number of participants who do not develop oral bacteria and Ventilator Associated Pneumonia when an oral rinse containing 0.12% Chlorhexidine Gluconate is used as part of a oral care protocol.|18 Months|Intention to Treat Analysis Used||participants|||Number
695980|NCT01382303|Secondary|Mean Change of TNF-a|changes in TNF-a from baseline to 24 weeks|baseline and 24 weeks|||pg/mL||Standard Deviation|Mean
695981|NCT01382303|Secondary|Mean Change of Fasting Glucose|changes serum fasting glucose from baseline to 24 weeks|baseline and 24 weeks|||mg/dL||Standard Deviation|Mean
695990|NCT01382225|Secondary|Proportion of Improved Scores on the Global Impact on Dry Eye Syndrome on Daily Life (GIDL) Rating|"The subject was asked on a questionnaire, Please consider how your dry eyes feel when doing daily activities such as working on the computer, watching television, reading, and driving. Based on this, please rate the impact of your dry eye symptoms on your daily life, and responded on a 4-point scale from 0-3 (0=Absent to 3=Severe). Improved was defined as a change in score of <0 from baseline. Proportion is reported as a percentage of participants. A greater percentage of subjects reporting a lower score indicates an improvement."|Baseline, Up to Day 14|Modified Intent-to-Treat||Percentage of Participants|||Number
695991|NCT01382225|Secondary|Percentage Change From Baseline in Global Symptom Composite Index (GSCI) Score|For each of 5 common dry eye symptoms, the frequency (0-3) and intensity (0-100) scores were multiplied to obtain the symptom score (0-300). The 5 symptom scores were summed to obtain the Global Symptom Composite Index Score (0-1500). A more negative percentage change indicates a greater amount of improvement.|Baseline, up to Day 14|Modified Intent-to-Treat||Percentage change||Standard Deviation|Mean
695992|NCT01382225|Secondary|Percentage Change From Baseline in Global Symptom Intensity (GSI) Total Score|The subject completed a questionnaire and rated the intensity of five common dry eye symptoms. Intensity was rated on a visual analog scale from 0-100 (0=no symptoms to 100=severe symptoms). The GSI Total Score (0 to 500) is the sum of the five individual ratings. A more negative percentage change indicates a greater amount of improvement.|Baseline, up to Day 14|Modified Intent-to-Treat||Percent change||Standard Deviation|Mean
695993|NCT01382225|Secondary|Percentage Change From Baseline in Schirmer I Score|The investigator placed a paper strip on the eye under the lower lid and left it in place for 5 minutes. The Schirmer I Score was the length of the strip wetted by the tears (0-35 millimeters). A more positive percentage change indicates a greater amount of improvement.|Baseline, up to Day 14|Modified Intent-to-Treat||Percent change||Standard Deviation|Mean
695994|NCT01382225|Secondary|Percentage Change From Baseline in Corneal Fluorescein Staining (CFS) Total Score|The investigator instilled an ophthalmic dye on the eye and rated corneal staining by type, extent/surface area, and depth. Each staining was rated on a 5-point scale from 0 to 4 (0=no staining/0% to 4=patch/>45%/immediate diffuse stromal glow). The CFS Total Score (0-12) is the sum of the three individual ratings. A more negative percentage change indicates a greater amount of improvement.|Baseline, up to Day 14|Modified Intent-to-Treat||Percent change||Standard Deviation|Mean
695995|NCT01382225|Secondary|Change From Baseline in GSF Total Score at Day 14|The subject completed a questionnaire and rated the frequency of five common dry eye symptoms. Frequency was rated on a 4-point scale from 0 to 3 (0=never to 3=constantly). The GSF Total Score (0-15) is the sum of the five individual ratings. A more negative change indicates a greater amount of improvement.|Baseline, Day 14|Modified Intent-to-Treat||Units on a scale||Standard Deviation|Mean
695996|NCT01382225|Secondary|Change From Baseline in LGS Total Score at Day 14|The investigator instilled an ophthalmic dye on the eye and rated staining in three areas (cornea, nasal, and temporal conjunctiva). Staining was rated on a 5-point scale from 0 to 4 (0=0% to 4=>45%). The LGS Total Score (0-12) is the sum of the three individual ratings. A more negative change indicates a greater amount of improvement.|Baseline, Day 14|Modified Intent-to-Treat||Units on a scale||Standard Deviation|Mean
695997|NCT01382225|Primary|Change From Baseline in Global Symptom Frequency (GSF) Total Score at Day 7|The subject completed a questionnaire and rated the frequency of five common dry eye symptoms. Frequency was rated on a 4-point scale from 0 to 3 (0=never to 3=constantly). The GSF Total Score (0-15) is the sum of the five individual ratings. A more negative change indicates a greater amount of improvement.|Baseline, Day 7|Modified Intent-to-Treat||Units on a scale||Standard Deviation|Mean
695998|NCT01382225|Primary|Change From Baseline in Lissamine Green Staining (LGS) Total Score at Day 7|The investigator instilled an ophthalmic dye on the eye and rated staining in three areas (cornea, nasal, and temporal conjunctiva). Staining was rated on a 5-point scale from 0 to 4 (0=0% to 4=>45%). The LGS Total Score (0-12) is the sum of the three individual ratings. A more negative change indicates a greater amount of improvement.|Baseline, Day 7|Modified Intent-to-Treat (mITT): The set of all randomized subjects who received at least one administration of the allocated product, had baseline efficacy measurement, had at least 1 post-baseline measurement and received the correct formulation of the lissamine green solution.||Units on a scale||Standard Deviation|Mean
695999|NCT01382212|Secondary|Number of Subjects With Potentially Clinically Significant Physical Examination Findings||Baseline (Day 1) and Final Visit (up to Week 12)|All-treated data set||participants|||Number
696000|NCT01382212|Secondary|Oral Body Temperature: Mean Change From Baseline to Final Visit||Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)|All-treated data set||degrees Celsius||Standard Deviation|Mean
696001|NCT01382212|Secondary|Heart Rate: Mean Change From Baseline to Final Visit|Heart rate was measured after the subject had been sitting for at least 3 minutes.|Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)|All-treated data set||bpm||Standard Deviation|Mean
696002|NCT01382212|Secondary|Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Mean Change From Baseline to Final Visit|Blood pressure was measured after the subject had been sitting for at least 3 minutes.|Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)|All-treated data set||mm Hg||Standard Deviation|Mean
696003|NCT01382212|Secondary|Number of Subjects With Potentially Clinically Significant Electrocardiogram (ECG) Findings|12-lead ECGs were recorded after the subject had been in the supine position for at least 5 minutes. The number of subjects with potentially clinically significant ECG findings, as determined by the investigator, is presented.|Baseline (Day 1) to Final Visit (up to Week 12)|All-treated data set||participants|||Number
696022|NCT01382186|Primary|Intention to Use Secure Messaging in the Future|Veteran respondent intention to use Secure Messaging in the future|baseline|This is a primary outcome for phase 2 of the study which was measured in random sample of 819 Veterans registered for My HealtheVet and opted in to use Secure Messaging. The sample of 33 Veterans from phase 1 was not included in this method of the study.||participant|||Number
696023|NCT01382186|Primary|Benefits of Using Secure Messaging|Veterans report benefits of using Secure Messaging|baseline|This is a primary outcome for phase 2 of the study which was measured in random sample of 819 Veterans registered for My HealtheVet and opted in to use Secure Messaging. The sample of 33 Veterans from phase 1 was not included in this method of the study.||participant|||Number
696004|NCT01382212|Secondary|Number of Subjects With Adverse Events|An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.|From first dose of study drug until 30 days following last dose of study drug (up to 16 weeks).|All-treated data set||participants|||Number
696005|NCT01382212|Secondary|Osteocalcin: Mean Change From Baseline to Final Visit||Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)|All subjects in the all-treated data set with evaluable data||ng/mL||Standard Deviation|Mean
696006|NCT01382212|Secondary|Fibroblast Growth Factor-23 (FGF-23), 1,25-Hydroxy Vitamin D, 25-Hydroxy Vitamin D, and Intact Parathyroid Hormone (iPTH): Mean Change From Baseline to Final Visit|n=subjects with evaluable Baseline and Post-baseline data for each parameter.|Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)|All-treated data set||pg/mL||Standard Deviation|Mean
696007|NCT01382212|Secondary|Total Protein and Albumin: Mean Change From Baseline to Final Visit|n=subjects with evaluable Baseline and Post-baseline data for each parameter.|Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)|All-treated data set||g/dL||Standard Deviation|Mean
696008|NCT01382212|Secondary|Sodium, Potassium, Chloride, Bicarbonate: Mean Change From Baseline to Final Visit||Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)|All subjects in the all-treated data set with evaluable data||mEq/L||Standard Deviation|Mean
696009|NCT01382212|Secondary|Alkaline Phosphatase: Mean Change From Baseline to Final Visit||Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)|All subjects in the all-treated data set with evaluable data||IU/L||Standard Deviation|Mean
696010|NCT01382212|Secondary|Bilirubin, Blood Urea Nitrogen (BUN), Uric Acid, Magnesium, Glucose, Cholesterol, Triglycerides, High Sensitivity C-Reactive Protein (hsCRP), Inorganic Phosphate, Corrected Calcium, and Creatinine: Mean Change From Baseline to Final Visit|n=subjects with evaluable Baseline and Post-baseline data for each parameter.|Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)|All subjects in the all-treated data set with evaluable data||mg/dL||Standard Deviation|Mean
696011|NCT01382212|Secondary|Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactic Dehydrogenase (LDH), and Bone-Specific Alkaline Phosphatase (BSAP): Mean Change From Baseline to Final Visit|n=subjects with evaluable Baseline and Post-baseline data for each parameter.|Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)|All subjects in the all-treated data set with evaluable data||U/L||Standard Deviation|Mean
696012|NCT01382212|Secondary|Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils: Mean Change From Baseline to Final Visit||Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)|All subjects in the all-treated data set with evaluable data||cells x 10^9/µL||Standard Deviation|Mean
696013|NCT01382212|Secondary|White Blood Cells (WBC) and Platelet Count: Mean Change From Baseline to Final Visit||Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)|All subjects in the all-treated data set with evaluable data||cells x 10^3/µL||Standard Deviation|Mean
696014|NCT01382212|Secondary|Red Blood Cells: Mean Change From Baseline to Final Visit||Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)|All subjects in the all-treated data set with evaluable data||cells x 10^6/µL||Standard Deviation|Mean
696015|NCT01382212|Secondary|Hematocrit: Mean Change From Baseline to Final Visit||Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)|All subjects in the all-treated data set with evaluable data||percent||Standard Deviation|Mean
696016|NCT01382212|Secondary|Hemoglobin: Mean Change From Baseline to Final Visit||Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)|All subjects in the all-treated data set with evaluable data||g/dL||Standard Deviation|Mean
696017|NCT01382212|Secondary|Percentage of Subjects With 2 Consecutive iPTH Reductions of at Least 30% From Baseline||Baseline (last measurement collected prior to the first dose) to Week 12|All-treated data set||percentage of participants||95% Confidence Interval|Number
696018|NCT01382212|Secondary|Percentage of Subjects With 2 Consecutive Intact Parathyroid Hormone (iPTH)/120 Between 150 and 300 pg/mL||Baseline (last measurement collected prior to the first dose) to Week 12|All-treated data set||percentage of participants||95% Confidence Interval|Number
696019|NCT01382212|Primary|Percentage of Subjects With Hypercalcemia|The percentage of subjects with hypercalcemia, defined as at least 2 consecutive post-baseline corrected calcium values > 10.2 mg/dL (2.55 mmol/L).|Day 1 to Week 12|All-treated data set: all subjects enrolled and administered at least 1 dose of paricalcitol||percentage of participants||95% Confidence Interval|Number
696020|NCT01382186|Primary|Veteran Need for Education Support for My HealtheVet and Secure Messaging Use.|Veterans were asked to report if they would like to have education and support using My HealtheVet and the Secure Messaging tool.|baseline|This is a primary outcome for phase 2 of the study which was measured in random sample of 819 Veterans registered for My HealtheVet and opted in to use Secure Messaging. The sample of 33 Veterans from phase 1 was not included in this method of the study.||participant|||Number
696021|NCT01382186|Primary|Veterans That Believed Improvements to the Secure Messaging System Would Make the Tool More Useful in the Future Are Presented in the Table.|Veterans were asked to report if improvements to the secure messaging system would make the tool more useful for use in the future.|baseline|This is a primary outcome for phase 2 of the study which was measured in random sample of 819 Veterans registered for My HealtheVet and opted in to use Secure Messaging. The sample of 33 Veterans from phase 1 was not included in this method of the study.||participant|||Number
709760|NCT00150969|Secondary|Effect of Vitamin K1 Supplementation on Levels of Bone Formation Marker|measured by osteocalcin on elecsys platform|0-24 months|||ng/ml||Standard Deviation|Mean
696024|NCT01382186|Primary|Reasons for Using Secure Messaging Tool on My HealtheVet|Participants reported reasons for Using Secure Messaging tool on My HealtheVet|baseline|This is a primary outcome for phase 2 of the study which was measured in random sample of 819 Veterans registered for My HealtheVet and opted in to use Secure Messaging. The sample of 33 Veterans from phase 1 was not included in this method of the study.||participant|||Number
696025|NCT01382186|Primary|Frequency of Electronic Resource Use|Mail surveys examine Veterans frequency of electronic resource use.|baseline|This is a primary outcome for phase 2 of the study which was measured in random sample of 819 Veterans. The purposive sample of 33 Veterans from phase 1 was not included in this method of the study.||participants|||Number
696026|NCT01382186|Primary|Secure Messaging Use and Content Patterns|Extraction of secure messages over a three-month time frame to examine message content type, including: general, tests, medication, and appointments.|3 months|This method of secondary data collection was conducted with the purposive sample of 33 Veterans in phase 1 of the study. The random sample of 819 Veteran survey respondents in phase 2 were not included in this method of data collection.||secure messages|Participants||Number
696027|NCT01382186|Primary|Usability of Secure Messaging|To determine ease of use and usefulness of secure messaging. Purposive sample of 33 participants were assessed for their ability to complete the following tasks: navigate to Secure Messaging, log-in to My HealtheVet and Secure Messaging, Set user preferences, check Secure Message inbox, open and send Secure Message, Open and read Secure Message attachment. Measured as: (1) able to complete task; (2) able to complete task with some difficulty; (3) not able to complete task.|baseline|This user-testing method was conducted with the first purposive sample of 33 participants in phase 1 of the study. The random sample of 819 participants in phase 2 were not a part of the user-testing study method.||participants|||Number
696028|NCT01382108|Primary|Tear Meniscus Height (TMH). The Height of the Tear Film Meniscus at the Eyelid Margin.|Assessments will be made in normal participants (no MGD) and participants with MGD and compared between the two groups at baseline and after the use of a meibomian gland evaluator.|Before and after the use of a meibomian gland evaluator. Assessments will be separated by a period of at least 10 minutes.|||mm||Standard Deviation|Mean
696029|NCT01382108|Primary|Tear Breakup Time (TBUT). The Time Taken, in Seconds, for the Tear Film to Break up on the Surface of the Cornea.|Measurements will be made in normal participants (no MGD) and participants with MGD and compared between the two groups at baseline and after the use of a meibomian gland evaluator.|Before and after the use of a meibomian gland evaluator. Assessments will be separated by a period of at least 10 minutes.|||seconds||Standard Deviation|Mean
696030|NCT01382108|Primary|Meibomium Gland Dropout Score - Evidence of Meibomian Gland Dysfunction (MGD) Confirmed by Meibograhpy Imaging Using the Keratograph 4 Measured on a Subjective Grading Scale (0-3) (Summing the Score for the Upper and Lower Lids for a Final Scale of 0-6)|"Assessments will be made in normal participants (no MGD) and participants with MGD and compared between the two groups at baseline and after the use of a meibomian gland evaluator.
The meibomium gland dropout score subjective grading scale:
0 = no loss of mebomium glands
= area of meibomium gland loss less than 33%
= area of meibomium gland loss between 33% and 67%
= area of meibomium gland loss more than 67%."|Before and after the use of a meibomian gland evaluator. Assessments will be separated by a period of at least 10 minutes.|||units on a scale||Standard Deviation|Mean
696031|NCT01381952|Other Pre-specified|Radiation Dose Measurements: Air Kerma (AK)|Percentage of dose reduction of ClarityIQ vs. AlluraXper in Air Kerma (AK) calculated by AK/frame.|Participants were followed for the duration of the procedure|All patients with recorded dose information and images for both angiograms were included (n=20)||percentage of dose reduction||Standard Deviation|Mean
696032|NCT01381952|Secondary|Radiation Dose Measurements: Dose Area Product (DAP)|Percentage of dose reduction of ClarityIQ vs. AlluraXper in Dose Area Product (DAP) calculated by DAP/frame.|Participants were followed for the duration of the procedure|All patients with recorded dose information and images for both angiograms were included (n=20)||percentage of dose reduction||Standard Deviation|Mean
696033|NCT01381952|Primary|Image Quality. For Each Included Participant 2 Images (1 AlluraXper; 1 AlluraClarity) Were Evaluated.|"The images were evaluated in randomized, blinded, offline readings. The anonymized images were displayed in pairs, i.e. the reference image run on one monitor (randomly left or right side) with the corresponding quarter-dose image run on the adjacent monitor. Three neuroradiologists graded the arterial, capillary, and venous phases separately. For each characteristic the images quality (IQ) were rated on a scale of 1 to 5 as 1 (very poor), 2 (mediocre), 3 (average), 4 (good), 5 (very good/excellent). An overall IQ score (3-15) was calculated as the sum of the score for these characteristics.
A paired Student's t test is used to compare the overall IQ score between the 2 imaging techniques. If the upper limit of the 97.5% one-sided CI for the difference overall IQ between the two treatment groups does not exceed the pre-defined non-inferiority margin of 2.5 Clarity will be declared non-inferior to the current image acquisition settings for DSA."|1 day|||Scores on a scale||95% Confidence Interval|Mean
696034|NCT01381926|Primary|Determine Changes in Bone Turnover Markers by Tartrate-Resistant Acid Phosphatase 5b (TRACP5b) During the Treatment With a GLP-1 Receptor Agonist (Exenatide) Compared to Placebo in Patients With T2DM.|Bone turnover by Tartrate-Resistant Acid Phosphatase 5b (TRACP5b) was assessed. Distribution of the Difference between EX/PBO Low/High Dose and Baseline Levels were calculated.|Baseline to 20 weeks|For Crossover, study, participants were matched for the placebo and study drug arms. As such, only data from participants completing both arms were included in the statistical analysis.||U/L||Standard Deviation|Mean
696035|NCT01381926|Primary|Determine Changes in Bone Turnover Markers by Serum N-Telo Peptide During the Treatment With a GLP-1 Receptor Agonist (Exenatide) Compared to Placebo in Patients With T2DM.|Bone turnover by Serum N-Telo peptide (NTX) was assessed. Distribution of the Difference between EX/PBO Low/High Dose and Baseline Levels were calculated|Baseline to 20 weeks|For Crossover, study, participants were matched for the placebo and study drug arms. As such, only data from participants completing both arms were included in the statistical analysis.||nMBCE/L||Standard Deviation|Mean
696036|NCT01381926|Primary|Determine Changes in Bone Resorption Markers During the Treatment With a GLP-1 Receptor Agonist (Exenatide) Compared to Placebo in Patients With T2DM.|Bone reabsorption by bone-specific alkaline phosphatase (BAP) was assessed. Distribution of the Difference between EX/PBO Low/High Dose and Baseline Levels were calculated.|Baseline to 20 weeks|For Crossover study, participants were matched for the placebo and study drug arms. As such, only data from participants completing both arms were included in the statistical analysis.||mg/L||Standard Deviation|Mean
696037|NCT01381900|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) <6.5% at Week 18|The table below shows the percentage of patients with HbA1c <6.5% at Week 18 in each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage.|Day 1 (Baseline) and Week 18|Analysis used overall mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 18 values. Table includes only participants with both baseline and post baseline values.||Percentage of patients|||Number
696038|NCT01381900|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) <7% at Week 18|The table below shows the percentage of patients with HbA1c <7% at Week 18 in each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage.|Day 1 (Baseline) and Week 18|Analysis used overall mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 18 values. Table includes only participants with both baseline and post baseline values.||Percentage of patients|||Number
696039|NCT01381900|Secondary|Percent Change in Body Weight From Baseline to Week 18|The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 18 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.|Day 1 (Baseline) and Week 18|Analysis used overall mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 18 values. Table includes only participants with both baseline and post baseline values.||Pecent change||Standard Error|Least Squares Mean
696040|NCT01381900|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 18|The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 18 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 18|Analysis used overall mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 18 values. Table includes only participants with both baseline and post baseline values.||mg/dL||Standard Error|Least Squares Mean
696041|NCT01381900|Primary|Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 18|The table below shows the least-squares (LS) mean change in HbA1c from baseline to Week 18 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 18|Analysis used overall mITT analysis set (all randomized patients who received at least 1 dose of double-blind study drug). Last-observation-carried-forward method used for missing Week 18 values. Table includes only participants with both baseline and post baseline values.||Percent||Standard Error|Least Squares Mean
696042|NCT01381679|Secondary|Change From Baseline in TG at Month 12||Baseline and Month 12|Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for TG.||mg/dL||95% Confidence Interval|Mean
696043|NCT01381679|Secondary|Change From Baseline in Triglycerides (TG) at Month 3||Baseline and Month 3|Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for TG.||mg/dL||95% Confidence Interval|Mean
696044|NCT01381679|Secondary|Change From Baseline in HDL-C at Month 12||Baseline and Month 12|Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for HDL-C.||mg/dL||95% Confidence Interval|Mean
696045|NCT01381679|Secondary|Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Month 3||Baseline and Month 3|Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for HDL-C.||mg/dL||95% Confidence Interval|Mean
696046|NCT01381679|Secondary|Change From Baseline in LDL-C at Month 12||Baseline and Month 12|Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for LDL-C.||mg/dL||95% Confidence Interval|Mean
696047|NCT01381679|Secondary|Change From Baseline in LDL-C at Month 3||Baseline and Month 3|Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for LDL-C.||mg/dL||95% Confidence Interval|Mean
696048|NCT01381679|Secondary|Change From Baseline in TC at Month 12||Baseline and Month 12|Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for TC.||mg/dL||95% Confidence Interval|Mean
696049|NCT01381679|Secondary|Change From Baseline in Total Cholesterol (TC) at Month 3||Baseline and Month 3|Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for TC.||mg/dL||95% Confidence Interval|Mean
696050|NCT01381679|Primary|Number of Participants Achieving Individual LDL Cholesterol (LDL-C) Target Level|Individual LDL-C target values were set according to the Austrian Cholesterol Consensus (ACC) 2007 for patients for patients suffering from coronary heart disease (CHD) or CHD equivalent in an office-based, routine medical care setting. Participants were categorized as either high-risk or very high-risk based on ACC criteria. The LDL-C target levels for each category were 100 mg/dL and 70 mg/dL, respectively|Up to 12 months|||Participants|||Number
696051|NCT01381575|Secondary|Anti-HPV-16 and Anti-HPV-18 Antibody Titres (by Pseudovirion-Based Neutralisation Assay [PBNA])|Antibody titers were given as Geometric mean titers (GMTs). The cut-off of the assay were ≥ 40 ED50 for anti-HPV-16 and anti-HPV-18.|At Day 0 and Months 7, 12, 18, 24 and 36|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Titer||95% Confidence Interval|Geometric Mean
696052|NCT01381575|Secondary|Anti-HPV-16 and Anti-HPV-18 Antibody Titres (by Pseudovirion-Based Neutralisation Assay [PBNA])|Antibody titers were given as Geometric mean titers (GMTs). The cut-off of the assay were ≥ 40 ED50 for anti-HPV-16 and anti-HPV-18.|At Months 0, 13, 18, 24 and 36|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Titer||95% Confidence Interval|Geometric Mean
696412|NCT01378429|Secondary|Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation.|Local Treatment-Emergent Adverse Events (ITT Population)|weeks 0-6|Intent-to-treat (ITT) Population: All randomized subjects who received at least 1 dose of double blind study medication.||participants|||Number
696053|NCT01381575|Secondary|Number of Subjects Completing the Vaccination Course|The number of subjects completing the vaccination course was assessed as the number of subjects with at least one dose received during the study.|Up to Month 13|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects, i.e. subjects who received at least one dose of vaccine in this study, for whom data were available.||Subjects|||Number
696054|NCT01381575|Secondary|Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific B Cell-mediated Immune Response|"The cell-mediated immune response was assessed as being the frequency of B-cell memory of HPV-18 antigen-specific memory B-cells per million memory B-cells in subjects with detectable B-cells. The results are presented by pre-vaccination status, where S- = seronegative subjects (antibody concentration < 7 EL.U/mL) prior to vaccination and S+ = seropositive subjects (antibody concentration ≥ 7 EL.U/mL) prior to vaccination.
For this group, results were only made available one month after the last vaccine dose, at Month 13."|At Months 0, 13, 18 and 36|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||cells/million B-cells||Inter-Quartile Range|Median
696055|NCT01381575|Secondary|Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific B Cell-mediated Immune Response|The cell-mediated immune response was assessed as being the frequency of B-cell memory of HPV-16 antigen-specific memory B-cells per million memory B-cells in subjects with detectable B-cells. The results are presented by pre-vaccination status, where S- = seronegative subjects (antibody concentration < 8 EL.U/mL) prior to vaccination and S+ = seropositive subjects (antibody concentration ≥ 8 EL.U/mL) prior to vaccination.|At Months 0, 13, 18 and 36|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||cells/million T-cells||Inter-Quartile Range|Median
696056|NCT01381575|Secondary|Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific B Cell-mediated Immune Response|The cell-mediated immune response was assessed as being the frequency of B-cell memory of HPV-18 antigen-specific memory B-cells per million memory B-cells in subjects with detectable B-cells. The results are presented by pre-vaccination status, where S- = seronegative subjects (antibody concentration < 7 EL.U/mL) prior to vaccination and S+ = seropositive subjects (antibody concentration ≥ 7 EL.U/mL) prior to vaccination.|At Day 0 and Months 7, 12, 24 and 36|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination and B-cell pre-vaccination status.||cells/million B-cells||Inter-Quartile Range|Median
696057|NCT01381575|Secondary|Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific B Cell-mediated Immune Response|The cell-mediated immune response was assessed as being the frequency of B-cell memory of HPV-16 antigen-specific memory B-cells per million memory B-cells in subjects with detectable B-cells. The results are presented by pre-vaccination status, where S- = seronegative subjects (antibody concentration < 8 EL.U/mL) prior to vaccination and S+ = seropositive subjects (antibody concentration ≥ 8 EL.U/mL) prior to vaccination.|At Day 0 and Months 7, 12, 24 and 36|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||cells/million B-cells||Inter-Quartile Range|Median
696058|NCT01381575|Secondary|Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T Cell-mediated Immune Response (CMI)|The CMI response was the measure of the cytokines production [IL-2, IFN-γ, TNF-α and CD40L] by HPV-antigen specific T lymphocytes and measured by intracellular cytokine staining (ICS) assay for HPV-18. The frequency was presented as number of cytokine-producing CD4+/CD8+ cells per million CD4+/CD8+ cells. All doubles= T cell expressing at least 2 cytokines. Results were tabulated by the pre-vaccination status of the subjects, where S- = seronegative subjects (antibody titre lower than the cut-off value of 7 EL.U/mL) prior to vaccination. S+ = seropositive subjects (antibody titre ≥ 7 EL.U/mL) prior to vaccination.|At Months 0, 13, 18 and 36|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||cells/million T-cells||Inter-Quartile Range|Median
696059|NCT01381575|Secondary|Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI)|The CMI response was the measure of the cytokines production [i.e.interleukin-2 (IL-2), interferon gamma (IFN-γ), tumor necrosis factor alpha (TNF-α) and cluster of differentiation 40 Ligand (CD40L)] by HPV-antigen specific T lymphocytes and measured by intracellular cytokine staining (ICS) assay for HPV-16 The frequency was presented as number of of cytokine-positive cluster of differentiation (CD)4 i.e.CD4+/CD8+ cells per million CD4+/CD8+ cells. All doubles= T cell expressing at least 2 cytokines. Results were tabulated by the pre-vaccination status of the subjects, where S- = seronegative subjects (antibody titre lower than the cut-off value of 8 EL.U/mL) prior to vaccination. S+ = seropositive subjects (antibody titre ≥ 8 El.U/mL) prior to vaccination.|At Months 0, 13, 18 and 36|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||cells/million T cells||Inter-Quartile Range|Median
696069|NCT01381575|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms.|Assessed solicited local symptoms were pain, redness and swelling. Any = Occurrence of any solicited local symptom regardless of their intensity grade. Grade 3 pain = Significant pain at rest, that prevented normal every day activity. Grade 3 redness/swelling = Redness/swelling above 50 millimeters (mm).|During the 7-day period (Days 0-6) following any vaccination|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects, i.e. subjects who received at least one dose of vaccine in this study, for whom data were available and symptom sheet completed.||Subjects|||Number
696413|NCT01378429|Secondary|Percentage of Subjects Experiencing AEs||weeks 0-6|Intent-to-treat (ITT) Population: All randomized subjects who received at least 1 dose of double blind study medication.||percentage of participants|||Number
696060|NCT01381575|Secondary|Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T Cell-mediated Immune Response (CMI)|"The CMI response was the measure of the cytokines production [IL-2, IFN-γ, TNF-α and CD40L] by HPV-antigen specific T lymphocytes and measured by intracellular cytokine staining (ICS) assay for HPV-18. The frequency was presented as number of cytokine-producing CD4+/CD8+ cells per million CD4+/CD8+ cells.
All doubles= T cell expressing at least 2 cytokines. Results were tabulated by the pre-vaccination status of the subjects, where S- = seronegative subjects (antibody titer lower than the cut-off value of 7 EL.U/mL) prior to vaccination. S+ = seropositive subjects (antibody titer ≥ 7 EL.U/mL) prior to vaccination."|At Day 0 and Months 7, 12, 24 and 36|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||cells/million T cells||Inter-Quartile Range|Median
696061|NCT01381575|Secondary|Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI)|"The CMI response was the measure of the cytokines production [i.e.interleukin-2 (IL-2), interferon gamma (IFN-γ), tumor necrosis factor alpha (TNF-α) and cluster of differentiation 40 Ligand (CD40L)] by HPV-antigen specific T lymphocytes and measured by intracellular cytokine staining (ICS) assay for HPV-16 The frequency was presented as number of of cytokine-positive cluster of differentiation (CD)4 i.e.CD4+/CD8+ cells per million CD4+/CD8+ cells.
All doubles= T cell expressing at least 2 cytokines. Results were tabulated by the pre-vaccination status of the subjects, where S- = seronegative subjects (antibody titre lower than the cut-off value of 8 EL.U/mL) prior to vaccination. S+ = seropositive subjects (antibody titre ≥ 8 El.U/mL) prior to vaccination."|At Day 0 and Months 7, 12, 24 and 36|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||cells/million T cells||Inter-Quartile Range|Median
696062|NCT01381575|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs)|"Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination."|From Day 0 up to Months 7, 13, 18, 24 and 36|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects, i.e. subjects who received at least one dose of vaccine in this study, for whom data were available.||Subjects|||Number
696063|NCT01381575|Secondary|Number of Subjects With Pregnancies Ongoing and Their Outcome|Specific pregnancy outcomes were elective termination with apparent congenital anomaly and ectopic pregnancy.|From Day 0 up to Months 7, 13, 24 and 36|The analysis was based on pregnant subjects from the Total Vaccinated cohort, which included all vaccinated subjects, i.e. subjects who received at least one dose of vaccine in this study, for whom data were available.||Subjects|||Number
696064|NCT01381575|Secondary|Number of Subjects With Medically Significant Conditions (MSCs)|MSC include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|From Day 0 to Months 7, 13, 24 and 36|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects, i.e. subjects who received at least one dose of vaccine in this study, for whom data were available.||Subjects|||Number
696065|NCT01381575|Secondary|Number of Subjects With Any Potential Immune-Mediated Diseases (pIMDs)|"pIMDs are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.
Note: Results up to Months 24 and 36 will be updated once they become available."|From Day 0 up to Months 7, 13, 18, 24 and 36|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects, i.e. subjects who received at least one dose of vaccine in this study, for whom data were available.||Subjects|||Number
696066|NCT01381575|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = Any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 = Unsolicited AE preventing normal activity. Related = Unsolicited AE assessed by the investigator as causally related to the study vaccination.|During the 30-day (Days 0-29) post vaccination period|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects, i.e. subjects who received at least one dose of vaccine in this study, for whom data were available.||Subjects|||Number
696067|NCT01381575|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.|Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, rash, fever and urticaria. Any = Occurrence of any solicited general symptom regardless of intensity grade or relationship to vaccination. Any Fever = Axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C). Grade 3 symptom = Symptom that prevented normal activity. Grade 3 fever = Fever > 39.0 °C. Related = General symptom assessed by the investigator as causally related to the vaccination.|During the 7-day period (Days 0-6) following any vaccination|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects, i.e. subjects who received at least one dose of vaccine in this study, for whom data were available and symptom sheet completed.||Subjects|||Number
696068|NCT01381575|Secondary|Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA).|Antibody concentrations were expressed as geometric mean titers (GMTs) and given in EL.U/mL, with the cut-off values of ≥ 8 ELISA units per millilitre (EL.U/mL) for HPV-16 and ≥ 7 EL.U/mL for HPV-18.|At Months 0, 13, 18, 24 and 36|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||EL.U/mL||95% Confidence Interval|Geometric Mean
696070|NCT01381575|Secondary|Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies|Seroconversion was defined as the appearance of antibodies (anti-HPV-16 titres ≥ 8 EL.U/mL and anti-HPV-18 titres ≥ 7 EL.U/mL) in the serum of subjects seronegative before vaccination. A seronegative subject was a subject with anti-HPV-16/18 antibody concentration < 8/7 EL.U/mL. A seropositive subject was a subject with anti-HPV-16/18 antibody concentration ≥ 8/7 EL.U/mL.|At Day 0 and Months 7, 12, 18, 24 and 36|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
696071|NCT01381575|Secondary|Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA).|Antibody concentrations were expressed as geometric mean titers (GMTs) and given in EL.U/mL, with the cut-off values of ≥ 8 ELISA units per millilitre (EL.U/mL) for HPV-016 and ≥ 7 EL.U/mL for HPV-018|At Day 0 and Months 7, 12, 18, 24 and 36|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||EL.U/mL||95% Confidence Interval|Geometric Mean
696072|NCT01381575|Secondary|Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies|Seroconversion was defined as the appearance of antibodies (anti-HPV-16 titres ≥ 8 EL.U/mL and anti-HPV-18 titres ≥ 7 EL.U/mL) in the serum of subjects seronegative before vaccination. A seronegative subject was a subject with anti-HPV-16/18 antibody concentration < 8/7 EL.U/mL. A seropositive subject was a subject with anti-HPV-16/18 antibody concentration ≥ 8/7 EL.U/mL.|At Months 0, 13, 18, 24 and 36|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
696073|NCT01381575|Primary|Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA).|Antibody concentrations were and expressed as geometric mean concentrations (GMCs) and expressed as enzyme-linked immunosorbent assay [ELISA] units per millilitre (EL.U/mL), with the cut-off values of 8 EL.U/mL for HPV-016 and 7 EL.U/mL for HPV-018.|1 month after the last dose of study vaccine (Month 7)|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||EL.U/mL||95% Confidence Interval|Geometric Mean
696074|NCT01381575|Primary|Number of Subjects Seroconverted for Anti- Human Papilloma Virus 16 (Anti-HPV-16) and Anti-Human Papilloma Virus 18 (Anti-HPV-18) Antibodies|Seroconversion was defined as the appearance of antibodies (anti-HPV-16 titres ≥ 8 ELISA units per millilitre (EL.U/mL) and anti-HPV-18 titres ≥ 7 EL.U/mL) in the serum of subjects seronegative before vaccination. A seronegative subject was a subject with anti-HPV-16/18 antibody concentration < 8/7 EL.U/mL. A seropositive subject was a subject with anti-HPV-16/18 antibody concentration ≥ 8/7 EL.U/mL.|1 month after the last dose of study vaccine (Month 7)|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
696075|NCT01381549|Secondary|Tmax of GSK2251052 Using Intensive PK Sampling|The planned pharmacokinetic (PK) and PK/pharmacodynamic analyses were not performed, because the PK data was not collected.|Day 4: Pre-dose (just prior to the start of the first infusion of the day) 0.5, 1 hour (just prior to the end of the infusion), 1.25, 1.5, 2, 3, 4, 8 and 12 hours post-dose||||||
696076|NCT01381549|Secondary|AUC of GSK2251052 Using Intensive PK Sampling|The planned pharmacokinetic (PK) and PK/pharmacodynamic analyses were not performed, because the PK data was not collected.|Day 4: Pre-dose (just prior to the start of the first infusion of the day) 0.5, 1 hour (just prior to the end of the infusion), 1.25, 1.5, 2, 3, 4, 8 and 12 hours post-dose||||||
696077|NCT01381549|Secondary|Cmax of GSK2251052 Using Intensive PK Sampling|The planned pharmacokinetic (PK) and PK/pharmacodynamic analyses were not performed, because the PK data was not collected.|Day 4: Pre-dose (just prior to the start of the first infusion of the day) 0.5, 1 hour (just prior to the end of the infusion), 1.25, 1.5, 2, 3, 4, 8 and 12 hours post-dose||||||
696078|NCT01381549|Secondary|Tmax of GSK2251052 Using Non-intensive PK Sampling|The planned pharmacokinetic (PK) and PK/pharmacodynamic analyses were not performed, because the PK data was not collected.|Day 4: Pre- dose (just prior to the start of the first infusion of the day) and 1 hour (just prior to the end of the infusion), 2, 4, and 12 hours post-dose||||||
696079|NCT01381549|Secondary|AUC of GSK2251052 Using Non-intensive PK Sampling|The planned pharmacokinetic (PK) and PK/pharmacodynamic analyses were not performed, because the PK data was not collected.|Day 4: Pre- dose (just prior to the start of the first infusion of the day) and 1 hour (just prior to the end of the infusion), 2, 4, and 12 hours post-dose||||||
696080|NCT01381549|Secondary|Cmax of GSK2251052 Using Non-intensive PK Sampling|The planned pharmacokinetic (PK) and PK/pharmacodynamic analyses were not performed, because the PK data was not collected.|Day 4: Pre- dose (just prior to the start of the first infusion of the day) and 1 hour (just prior to the end of the infusion), 2, 4, and 12 hours post-dose||||||
696081|NCT01381549|Secondary|Time to Cmax (Tmax) of GSK2251052|The planned pharmacokinetic (PK) and PK/pharmacodynamic analyses were not performed, because the PK data was not collected.|Day 3: Pre- dose (just prior to the start of the first infusion of the day) and 1 hour (just prior to the end of the infusion), 2, 4, and 12 hours post-dose||||||
696082|NCT01381549|Secondary|Area Under the Concentration Time Curve (AUC) of GSK2251052|The planned pharmacokinetic (PK) and PK/pharmacodynamic analyses were not performed, because the PK data was not collected.|Day 3: Pre- dose (just prior to the start of the first infusion of the day) and 1 hour (just prior to the end of the infusion), 2, 4, and 12 hours post-dose||||||
696083|NCT01381549|Secondary|Maximum Plasma Concentration (Cmax) of GSK2251052|The planned pharmacokinetic (PK) and PK/pharmacodynamic analyses were not performed, because the PK data was not collected.|Day 3: Pre- dose (just prior to the start of the first infusion of the day) and 1 hour (just prior to the end of the infusion), 2, 4, and 12 hours post-dose||||||
696084|NCT01381549|Secondary|Therapeutic Response (Combined Clinical and Microbiological Response) at the End of IV Visit and Late Follow-Up Visit|The therapeutic response was the combination of a participant’s clinical and microbiological response. It was assessed at the Test of Cure visit in participants who have a qualifying Gram-negative uropathogen at Baseline and have had a minimum of 5 days of IV therapy. Therapeutic response was a measure of the overall efficacy response, and a therapeutic success referred to participants who have been deemed both a 'clinical success' and a 'microbiological success'. All other combinations (other than 'clinical success' + 'microbiological success') were deemed failures for therapeutic response.|End of IV therapy (0-24 hours post-therapy) and Late Follow-up (21-28 days post-therapy)|MITT Population.||Participants|||Count of Participants
696085|NCT01381549|Secondary|Clinical Response at the End of IV Therapy Visit, Test of Cure Visit and Late Follow-Up Visit|Clinical response was a combination of clinical success and clinical failure. In clinical success, participants showed no signs and symptoms of pyelonephritis and lower complicated urinary tract infection and antibiotics are not used for the same. In clinical failure, there is reappearance of signs and symptoms of and lower complicated urinary tract infection and participant required antibiotics for the same.|End of IV therapy (0-24 hours post-therapy), Test of Cure Visit (5 to 9 days post-IV therapy) and Late Follow-up (21-28 days post-therapy)|MITT Population.||Participants|||Count of Participants
696086|NCT01381549|Secondary|Microbiological Response at the End of IV Therapy Visit, Test of Cure Visit and Late Follow-Up Visit|Microbiological response involved both microbiological success and microbiological failure. A reduction in the uropathogens in the urine culture and no growth on blood culture was termed as microbiological success. Increase in the uropathogens in the urine culture and pathogens identified in the blood culture or use of antibacterials other than study treatments were classified as microbiological failures.|End of IV therapy (0-24 hours post-therapy), Test of Cure Visit (5 to 9 days post-IV therapy) and Late Follow-up (21-28 days post-therapy)|MITT Population.||Participants|||Count of Participants
696087|NCT01381549|Primary|Change From Baseline in Hematology Parameters- Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils and White Blood Cell Count (WBC)|Hematology parameters included basophils, eosinophils, lymphocytes, monocytes, platelet count, total neutrophils and WBC. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in basophils, eosinophils, lymphocytes, monocytes, platelet count, total neutrophils and WBC are presented.|Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)|Safety Population. Only those participants available at the specified time points were analyzed.||Gigacells per Liter||Standard Deviation|Mean
696088|NCT01381549|Primary|Change From Baseline in Hematology Parameters- Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC)|Hematology parameters included hemoglobin and MCHC. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in hemoglobin and MCHC are presented.|Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)|Safety Population. Only those participants available at the specified time points were analyzed.||Gram per Liter||Standard Deviation|Mean
696089|NCT01381549|Primary|Change From Baseline in Hematology Parameters- Red Blood Cell (RBC) Count and Reticulocytes|Hematology parameters included RBC count and reticulocytes. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in RBC count and reticulocytes are presented.|Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)|Safety Population. Only those participants available at the specified time points were analyzed.||Trillion cells per liter||Standard Deviation|Mean
696090|NCT01381549|Primary|Change From Baseline in Hematology Parameters- Mean Corpuscle Volume (MCV)|Hematology parameters included MCV. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in MCV are presented.|Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)|Safety Population. Only those participants available at the specified time points were analyzed.||Femtoliters||Standard Deviation|Mean
696091|NCT01381549|Primary|Change From Baseline in Hematology Parameters- Mean Corpuscle Hemoglobin (MCH)|Hematology parameters included MCH. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in MCH are presented.|Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)|Safety Population. Only those participants available at the specified time points were analyzed.||Picograms||Standard Deviation|Mean
696092|NCT01381549|Primary|Change From Baseline in Hematology Parameters- Hematocrit|Hematology parameters included hematocrit. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in hematocrit are presented.|Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)|Safety Population. Only those participants available at the specified time points were analyzed.||Fraction||Standard Deviation|Mean
696093|NCT01381549|Primary|Therapeutic Response at the Test of Cure Visit|The therapeutic response was the combination of a participant’s clinical and microbiological response. It was assessed at the Test of Cure visit in participants who have a qualifying Gram-negative uropathogen at Baseline and have had a minimum of 5 days of IV therapy. Therapeutic response was a measure of the overall efficacy response, and a therapeutic success referred to participants who have been deemed both a 'clinical success' and a 'microbiological success'. All other combinations (other than 'clinical success' + 'microbiological success') were deemed failures for therapeutic response.|Test of Cure Visit (5 to 9 days post-IV therapy)|Microbiological Intent to Treat (MITT) comprised of all randomized participants who received at least one dose of study medication and had at least one gram-negative uropathogen and no more than two gram-negative uropathogens (≥10^5 Colony forming units [CFU]/mL for each pathogen) identified from Baseline urine culture.||Participants|||Count of Participants
696094|NCT01381549|Primary|Summary of Vital Signs- Mean Temperature|Vital sign measurements included temperature (oral, tympanic or rectal). Measurements that deviated substantially from previous readings were repeated immediately. Temperature was assessed as normal hospital practice dictated and the maximum daily temperature was recorded in the electronic case report form (eCRF).|Up to Late Follow up Visit (21 to 28 days post-IV therapy)|Safety Population. Only those participants available at the specified time points were analyzed.||Celsius||Standard Deviation|Mean
696095|NCT01381549|Primary|Summary of Vital Signs- Mean Respiration Rate|Vital sign measurements included respiratory rate. Measurements that deviated substantially from previous readings were repeated immediately. Mean respiration rate are presented.|Up to Late Follow-up Visit (21 to 28 days post-IV therapy)|Safety Population. Only those participants available at the specified time points were analyzed.||Breaths/minute||Standard Deviation|Mean
696096|NCT01381549|Primary|Summary of Vital Signs- Mean Heart Rate|Vital sign measurements included heart rate. Measurements that deviated substantially from previous readings were repeated immediately. Mean heart rate is presented.|Up to Late Follow-up Visit (21 to 28 days post-IV therapy)|Safety Population. Only those participants available at the specified time points were analyzed.||Beats per minute||Standard Deviation|Mean
696097|NCT01381549|Primary|Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Vital sign measurements included SBP and DBP (supine or semi-supine). Measurements that deviated substantially from previous readings were repeated immediately. Mean SBP and DBP are presented.|Up to Late Follow up Visit (21 to 28 days post-IV therapy)|Safety Population. Only those participants available at the specified time points were analyzed.||Millimeters of mercury (mmHg)||Standard Deviation|Mean
696098|NCT01381549|Primary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings|Twelve lead ECGs were obtained during the study using an ECG machine that automatically measured PR, QRS, QT, and QT corrected by Bazett's formula (QTcB), QT corrected by Fridericia's formula (QTcF) intervals. Twelve lead ECGs were performed with the participant in a semi-supine position having rested in this position for at least 10 minutes beforehand. Measurements that deviated substantially from previous readings were repeated immediately. Three measurements were taken at pre-dose on Day 1 at least 5 min apart. One additional ECG measurement was taken after completion of the first infusion of study medication. Two ECG measurements (pre and post-1st infusion of the day) were taken on Day 4 while the participant was on IV therapy. When there was an abnormal finding, two more were taken and the mean PR interval, QRS duration, QT interval and QTcB were calculated from automated ECG readings. One ECG measurement was taken at the early safety follow-up visit.|Up to Late Follow-up Visit (21 to 28 days post-IV therapy)|Safety Population. Only those participants available at the specified time points were analyzed.||Participants|||Count of Participants
696099|NCT01381549|Primary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant.|Up to 28 days post-therapy|Safety Population.||Participants|||Count of Participants
696100|NCT01381549|Primary|Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT)|Clinical laboratory parameters included ALT, ALP, AST, Creatine kinase and GGT. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in ALT, ALP, AST, Creatine kinase and GGT are presented.|Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)|Safety Population. Only those participants available at the specified time points were analyzed.||International units per Liter||Standard Deviation|Mean
696101|NCT01381549|Primary|Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN)|Clinical laboratory parameters included C02 content/bicarbonate, chloride, glucose, potassium, sodium and urea/BUN. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in C02 content/bicarbonate, chloride, glucose, potassium, sodium and urea/BUN are presented.|Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)|Safety Population. Only those participants available at the specified time points were analyzed.||Millimole per Liter||Standard Deviation|Mean
696102|NCT01381549|Primary|Change From Baseline in Clinical Laboratory Parameters- Creatinine, Direct Bilirubin and Total Bilirubin|Clinical laboratory parameters included creatinine, direct bilirubin and total bilirubin. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in creatinine, direct bilirubin and total bilirubin are presented.|Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)|Safety Population. Only those participants available at the specified time points were analyzed.||Micromole per liter||Standard Deviation|Mean
696103|NCT01381549|Primary|Change From Baseline in Clinical Laboratory Parameters- Creatinine Clearance, Estimated (CCE)|Clinical laboratory parameters included CCE. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in CCE are presented.|Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)|Safety Population. Only those participants available at the specified time points were analyzed.||Milliliter per minute||Standard Deviation|Mean
696104|NCT01381549|Primary|Change From Baseline in Clinical Laboratory Parameters- Albumin and Total Protein|Clinical laboratory parameters included albumin and total protein. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in albumin and total protein are presented.|Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)|Safety Population which comprised of all participants who received at least one dose of study medication. Only those participants available at the specified time points were analyzed.||Gram per Liter||Standard Deviation|Mean
696117|NCT01380782|Other Pre-specified|Exploratory Objective #4: Determination if Any Correlation Exists Between Patient Outcomes (Survival, PFS3, PFS6) and Perfusion MRI, Diffusion MRI|To explore the correlation between perfusion MRI, diffusion MRI and response to therapy.|2 years||||||
696414|NCT01378429|Secondary|Number of Subjects Experiencing AEs||weeks 0-6|Intent-to-treat (ITT) Population: All randomized subjects who received at least 1 dose of double blind study medication.||participants|||Number
696105|NCT01381471|Primary|Mean Number of Healthcare Encounters Incurred by Participants During the Post-Index Period|The mean number of outpatient office visits, inpatient visits, and emergency department visits incurred by participants during the one-year post-index period was measured.|One Year|Participants age 40 or older with at least one pharmacy claim for FSC, at least one medical claim with a primary or secondary diagnosis of COPD (ICD-9 codes 490.xx, 491.xx, 492.xx, or 496.xx), and at least one pharmacy claim for an anticholinergic medication but no diagnosis for cystic fibrosis (ICD-9 = 277.0x)||healthcare encounters||Standard Deviation|Mean
696106|NCT01381471|Primary|Mean Number of Pharmacy Claims by Participants During the Post-Index Period|The mean number of pharmacy claims incurred by participants during the one-year post-index period was measured.|One Year|Participants age 40 or older with at least one pharmacy claim for FSC, at least one medical claim with a primary or secondary diagnosis of COPD (ICD-9 codes 490.xx, 491.xx, 492.xx, or 496.xx), and at least one pharmacy claim for an anticholinergic medication but no diagnosis for cystic fibrosis (ICD-9 = 277.0x)||pharmacy claims||Standard Deviation|Mean
696107|NCT01381406|Secondary|Incidence Rate of Hospitalizations and Emergency Room Visits Per 100 Person Years|Unadjusted incidence rates per 100 person years of chronic obstructive pulmonary disease (COPD)-related hospitalizations and emergency department visits by treatment group are presented. Incidence rate is calculated by dividing the number of healthcare service encounters by the number of person years of follow up. Person years adjust for different lengths of follow up for individual participants|Data were collected over a maximum period of 4 years|Managed care enrollees (aged >40 years) with at least one COPD-related exacerbation at baseline and newly initiating therapy with TIO with or without the addition of FSC during the study enrollment period was the target population. The date of TIO-alone therapy or TIO+FSC add-on date was the index date.||visits per 100 person years|||Number
696108|NCT01381406|Secondary|Adjusted Mean Monthly Costs Per COPD Patient by Treatment Group|The mean costs of health care encounters adjusted to control for baseline differences between treatment groups and reported in 2008 United States dollars as calculated with the consumer price index (CPI) are presented. CPI is standard multiplier for adjusting the cost of goods and services to a single year. Total costs include pharmacy and medical costs. Medical costs were computed from the paid amounts of medical claims with a primary diagnosis code for COPD. COPD-related pharmacy costs were computed from paid amounts of COPD-related prescription medications.|Data were collected over a maximum period of 4 years|Managed care enrollees (aged >40 years) with at least one COPD-related exacerbation at baseline and newly initiating therapy with TIO with or without the addition of FSC during the study enrollment period was the target population. The date of TIO-alone therapy or TIO+FSC add-on date was the index date.||United States dollars||95% Confidence Interval|Mean
696109|NCT01381406|Primary|Incidence Rate Per 100 Person Years of Hospitalization or Emergency Department (ED) Visit Related to Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)|A severe exacerbation is defined as one with a primary diagnosis of COPD. A moderate exacerbation is an ED visit with a primary diagnosis of COPD, a physician visit with a diagnosis of COPD and a prescription for an oral corticosteroid, a physician visit with a diagnosis code for COPD and an antibiotic for respiratory infection, or physician administration of nebulized albuterol within 3 days of an office visit. Incidence rate is calculated by dividing the number of exacerbations by the number of person years. Person years adjust for different lengths of follow up for participants.|Data were collected over a maximum period of 4 years|Managed care enrollees (aged >40 years) with at least one COPD-related exacerbation at baseline and newly initiating therapy with TIO with or without the addition of FSC during the study enrollment period was the target population. The date of TIO-alone therapy or TIO+FSC add-on date was the index date.||exacerbations per 100 person years|||Number
696110|NCT01381120|Secondary|Change in Post-ureteroscopy Stent-induced Lower Urinary Tract Symptoms.|Measured through the use of the ureteral stent symptom questionnaire. Patients reported symptoms on a scale of 1 to 5 (1 being the absence of symptoms and 5 being very debilitating symptoms). The questionnaire was administered a couple days post-op and once again several weeks later. The mean difference (baseline minus 3 months) on this continuous scale was used for this outcome measure.|Baseline and three months.|||units on a scale||95% Confidence Interval|Mean
696111|NCT01381120|Primary|Change in Post-ureteroscopy Stent-induced Pain|Measured through the use of the ureteral stent symptom questionnaire. Patients reported pain on a scale of 0 to 10 (0 being the absence of pain and 10 being the most excruciating pain of their life). The questionnaire was administered a couple days post-op and once again several weeks later. The mean difference (baseline minus 3 months) on this continuous scale was used for this outcome measure.|Baseline and 3 months.|||units on a scale||95% Confidence Interval|Mean
696112|NCT01381016|Primary|Luteinizing Hormone Pulse Amplitude||Post estradiol at one month|||IU/L||Standard Error|Mean
696113|NCT01381016|Primary|Luteinizing Hormone Pulse Amplitude|The study is powered on luteinizing hormone pulse amplitude because it is the clinical outcome for which the most data is available. The primary comparison is whether there is a significant reduction in the pulse amplitude in the obese between the pre- and post-treatment periods and whether there is no change in the pulse amplitude in the normal weight patients between the pre and post-treatment periods.|Baseline|||IU/L||Standard Error|Mean
696114|NCT01380834|Secondary|Opioid Consumption|Other secondary end points will total amount of fentanyl (mcg/kg), dilaudid (mcg/kg), oxycodone (mg/kg) and morphine (mg/kg) (after conversion of above opioids to morphine based on opioids potency) used at 24 hours postoperatively (or until the patient is discharged, if sooner).|24 hrs after blocks were done or until the patient is discharged|||mg/kg||Standard Deviation|Mean
696115|NCT01380834|Secondary|Postoperative Pain Scores Assessed Using Visual Analog Scale (VAS).|The VAS (Visual Analog Scale, 0 mm “no pain”, to 100 mm,” the worst pain possible “) is used to assess postoperative pain for patients. Postoperative pain scores will be assessed and compared at 4, 8, 12, 18 and 24 hr after paravertebral block.|24 hrs after blocks were done or until the patient is discharged|||units on a scale||Standard Deviation|Mean
696116|NCT01380834|Primary|Opioids Consumption Via PCA|The primary end-point of this research is the amount of dilaudid (ng/kg/min) administered via Patient Controlled Analgesia (PCA), 12 hours after administration of ropivacaine 0.5% /normal saline in paravertebral space and administration of normal saline/ropivacaine 0.5% at all four laparoscopic ports.|12 hrs after the blocks were done|||ng/kg/min||Standard Deviation|Mean
702002|NCT00075088|Primary|Hospital Time to Treatment for Patients With ST-elevation Myocardial Infarction (STEMI)|Mean door-to-balloon time|Day 1|42 patients with STEMI who received primary percutaneous coronary intervention||minutes||Standard Deviation|Mean
696118|NCT01380782|Other Pre-specified|Exploratory Objective #3: Determination if Any Correlation Exists Between Patient Outcomes (Survival, PFS3, PFS6) and Serum Angiogenic Peptides, Circulating Endothelial Cells, and/or Circulating Progenitor Cells|To explore the correlation between serum angiogenic peptides, circulating endothelial cells, and circulating progenitor cells with response to therapy.|2 years||||||
696119|NCT01380782|Other Pre-specified|Exploratory Objective #2: Determination if Any Correlation Exists Between Patient Outcomes (Survival, PFS3, PFS6) and Tumor Genotype and/or Expression Profile|To explore the extent to which the tumor's genotype and expression profile correlate with outcome.|2 years||||||
696120|NCT01380782|Other Pre-specified|Exploratory Objective #1: Progression-free Survival at 3- and 6-months for Participants With Recurrent Anaplastic Gliomas (AG)|To explore the efficacy of BIBF 1120 in bevacizumab-naïve and bevacizumab-treated participants with recurrent anaplastic gliomas (AG) survival was assessed at 6 months for Arm A and 3 months for Arm B.|Arm A - 6 months; Arm B - 3 months|||percentage of participants|||Number
696121|NCT01380782|Secondary|Safety Profile as Summarized With Descriptive Statistics (Using Toxicity Data Gathered on Trial)|Safety profile in both populations - as adverse events are posted separately in detail, these results will demonstrate serious adverse events (defined as grades 3-5) that were judged at least possibly related to Nintedanib (BIBF 1120).|2 years|||number of incidents|||Number
696122|NCT01380782|Secondary|Time-to-tumor Progression|Time-to-tumor progression in both populations.|2 years|||days||95% Confidence Interval|Median
696123|NCT01380782|Secondary|Overall Survival|Overall survival in both populations|2 years|||months||95% Confidence Interval|Median
696124|NCT01380782|Secondary|Proportion of Participants Experiencing Stable Disease (SD) as Their Best Radiographic Response|Best radiographic response in both populations. There were no participants with partial or complete responses, so the results are being reported in the proportion of participants who experienced stable disease (SD) as their best response (as opposed to progressive disease).|2 years|||% of patients with best response SD|||Number
696125|NCT01380782|Primary|3-Month Progression Free Survival|To determine the efficacy of BIBF 1120 in bevacizumab-treated participants with recurrent GBM as measured by 3-month progression free survival (PFS3).|3 months|||percentage of participants|||Number
696126|NCT01380782|Primary|6-Month Progression Free Survival|To determine the efficacy of BIBF 1120 in bevacizumab-naive participants with recurrent glioblastoma (GBM) as measured by 6-month progression-free survival (PFS6).|Six months|||percentage of participants|||Number
696127|NCT01380769|Secondary|Assess Objective Response Rate (ORR) of CRLX101+ BSC Compared to BSC Only|Comparison of objective response rate in subjects treated with CRLX101+BSC versus subjects treated with BSC alone.|12 months|Intention-To-Treat (ITT)||Percentage of Participants|||Number
696128|NCT01380769|Primary|To Compare Overall Survival of Patients Treated With CRLX101 + BSC to Those Patients Treated With BSC Only|Comparison of survival among patients treated with CRLX101 + best supportive care vs patients treated wiht best supportive care only.|Up to 18 months|Intention-to-treat (ITT) and Patient Safety Population (PSP), includes all CRLX101 + BSC subjects who received at least 1 dose of study treatment and all randomized BSC alone subjects who attended at least 1 study visit. (Confidence interval if insufficient data to estimate NE = 99999.99)||months||95% Confidence Interval|Median
696129|NCT01380730|Secondary|Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12||Baseline and Week 12|Full analysis set; missing data at Week 12 were imputed using LOCF.||percent change||Standard Error|Least Squares Mean
696130|NCT01380730|Secondary|Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12||Baseline and Week 12|Full analysis set; missing data at Week 12 were imputed using LOCF.||percent change||Standard Error|Least Squares Mean
696131|NCT01380730|Secondary|Percent Change From Baseline in Apolipoprotein B at Week 12||Baseline and Week 12|Full analysis set; missing data at Week 12 were imputed using LOCF.||percent change||Standard Error|Least Squares Mean
696132|NCT01380730|Secondary|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12||Baseline and Week 12|Full analysis set; missing data at Week 12 were imputed using LOCF.||percent change||Standard Error|Least Squares Mean
696133|NCT01380730|Secondary|Change From Baseline in LDL-C at Week 12|LDL-C was measured using ultracentrifugation.|Baseline and Week 12|Full analysis set; missing data at Week 12 were imputed using LOCF.||mg/dL||Standard Error|Least Squares Mean
696134|NCT01380730|Primary|Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12|LDL-C was measured using ultracentrifugation.|Baseline and Week 12|Full analysis set; missing ultracentrifugation LDL-C at Week 12 was imputed using last observation carried forward (LOCF) and calculated LDL-C.||percent change||Standard Error|Least Squares Mean
696135|NCT01380639|Secondary|Brain Natruretic Peptide (BNP)|change in BNP from baseline to day 19|day 1, day 19||||||
696136|NCT01380639|Secondary|Arterial Blood Gas||day 1||||||
696137|NCT01380639|Secondary|Lung Function||day 1||||||
696138|NCT01380639|Secondary|BODE-Score|Change in Bode-Score from baseline to day 19|day 1, day 19||||||
696139|NCT01380639|Secondary|Isometric Maximum Handgrip Force|change in isometric max. handgrip force from baseline to day 19|day 1, day 19||||||
696140|NCT01380639|Secondary|Body Composition|Change in body composition from baseline to day 19|day 1 and 19||||||
696141|NCT01380639|Primary|6-Minute-Walking-Distance|Change in 6-minute-walking-distance from baseline to day 19|day 1, day 19|||m||Standard Deviation|Mean
696142|NCT01380379|Secondary|Change in Assertiveness Between Baseline and Post-intervention|"Measured by the Rathus Assertiveness Schedule (Rathus, 1973). Rathus Assertiveness Scale is a 30-item scale assessing assertive behavior in a variety of situations. Each item is rated on a 6-point Likert scale from +3 (very characteristic of me) to -3 (very uncharacteristic of me). Total scores range from +90, which is equivalent of very assertive behavior to -90, which is equivalent to very unassertive behavior.
The positive change indicates an increase in assertive behavior."|Change in assertiveness from baseline to post-class (8 weeks)|||units on a scale||Standard Deviation|Mean
696143|NCT01380379|Primary|Change in Self-efficacy From Baseline to Post-treatment|General self-efficacy (Schwartz and Jerusalem, 1993) is a measure of one's perceived self-competence. Scores are summed across 10 items, and range between 10-40, where higher scores reflect a stronger sense of personal competence.|Change in GSE from baseline to 8 weeks|The data is the change in general self efficacy from baseline to post-class, with higher scores indicating a greater increase in self-efficacy||units on a scale||Standard Deviation|Mean
696144|NCT01380366|Secondary|To Evaluate Liver Enzymes in Total Parenteral Nutrition (TPN)-Dependent Short Bowel Syndrome Patients Before and After Administration of Zorbtive®.|Following completion of Visit 2, study staff will obtain results of liver injury/function tests (ALT, Aspartate transaminase (AST), bilirubin, alkaline phosphatase (ALK or ALP), GGT) from the medical record from each routine clinical exam from Month 3 through Month 24. Results that show decreased liver injury (ALT, AST, bilirubin, alkaline phosphate (ALK or ALP), GGT) will show Zorbtive administration enhanced intestinal permeability and enhanced liver function.|(Visit 1) Baseline, (Visit 2) 28-31 days after baseline, then at regularly scheduled follow-up clinic visits for two years from Month 3 through Month 24|||participants|||Number
696145|NCT01380366|Primary|To Identify Small Intestinal Permeability Changes in Short Bowel Syndrome Patients After Administration of Recombinant Human Growth Hormone (Zorbtive®).|Permeability changes will be identified in short bowel syndrome patients by evaluating concentration of lactulose, mannitol and sucralose from Visit 1 to Visit 2. A decrease in concentration of sucralose in urine indicates Zorbtive potentially enhancing intestinal barrier function.|(Visit 1) Baseline to (Visit 2) 28-31 days after baseline|||participants|||Number
696146|NCT01380327|Secondary|Percent of Participants With the Occurrence of Adverse Events (AEs)|Percent of participants who experienced at least one AE.|Participant enrollment to end of study (up to 3 months post-baseline)|||Percentage of population|||Number
696147|NCT01380327|Secondary|Change in IgE Fragment Antibody Binding (FAB) Activity Over Time|Outcome is change in mean IgE FAB activity level from baseline to post-baseline (status post 3 months of treatment). Serum from cockroach sublingual immunotherapy (SLIT)-treated participants were analyzed to determine if treatment inhibits in-vitro cockroach SLIT, using the per protocol allergenic extract doses. This result is an indicator of immune modulation over time, however its clinical significance is unclear.(Reference: Shamji MH et al. The IgE-facilitated allergen binding (FAB) assay: validation of a novel flow-cytometric based method for the detection of inhibitory antibody responses. J Immunol Methods 2006;317(1-2): 71-9).|Baseline through 3 months of treatment|Intent-to-treat population with complete data.||Percent antibody binding||95% Confidence Interval|Mean
696148|NCT01380327|Secondary|Change in German Cockroach-Specific Serum IgG4 Over Time|Outcome is the ratio of geometric means for baseline versus post-baseline German cockroach-specific serum immunoglobulin subclass 4 (IgG4). This result is an indicator of immune modulation over time, however its clinical significance is unclear.|Baseline through 3 months of treatment|Intent-to-treat population with complete data.||Ratio||95% Confidence Interval|Geometric Mean
696149|NCT01380327|Secondary|Change in German Cockroach-Specific Serum IgG Over Time|Outcome is the ratio of geometric means for baseline versus post-baseline German cockroach-specific serum immunoglobulin G (IgG). This result is an indicator of immune modulation over time, however its clinical significance is unclear.|Baseline through 3 months of treatment|Intent-to-treat population with complete data.||Ratio||95% Confidence Interval|Geometric Mean
696150|NCT01380327|Primary|Change in German Cockroach-Specific Serum IgE Over Time|Outcome is the ratio of geometric means for baseline versus post-baseline German cockroach-specific serum IgE. This result is an indicator of immune modulation over time, however its clinical significance is unclear.|Baseline through 3 months of treatment|Intent-to-treat population with complete data.||Ratio||95% Confidence Interval|Geometric Mean
696151|NCT01380197|Secondary|Pain Relief||2 days|||participants|||Number
696152|NCT01380197|Primary|Acute Chest Syndrome|A new pulmonry infiltrate on Chest X-ray|3 days|||participants|||Number
696153|NCT01380145|Secondary|Assessment of Survival and Time to Subsequent Therapy|Progression-free survival (PFS) was calculated as the date from first immunization to first observation of disease progression or death due to any cause, censored on the start date of subsequent therapy or at the last date of disease assessment for subjects without a PFS event. Overall survival (OS) was calculated as the date from first immunization to death due to any cause, censored at the date of last follow-up for subjects who were alive at the time of the analysis. Time to subsequent therapy was calculated as the date from first immunization to start of subsequent therapy for myeloma, censored at the date of death or last follow-up for subjects who did not receive subsequent therapy.|Continuously on study and for up to 5 years post-study|The Evaluable Analysis Set comprises all subjects who received at least 1 immunization with study drug and had a baseline and at least 1 post-baseline disease assessment.||days||Full Range|Median
696154|NCT01380145|Secondary|Assessment of Tumor Response|"Tumor responses were evaluated using appropriate imaging methods and were categorized according to the IMWG criteria, which includes the following response designations:
Complete Response (CR): negative immunofixation on serum/urine, disappearance of soft tissue plasmacytomas, <5% plasma cells in bone marrow; Stringent CR (sCR): CR + normal free light chain (FLC) ratio and absence of clonal cells in bone marrow; Very Good Partial Response (VGPR): Serum/urine M-component detectable by immunofixation but not electropheresis OR ≥90% reduction in serum M-component + urine M-component <100 mg/24 hrs; Partial Response (PR): ≥50% reduction of serum M-protein and reduction in 24-hr urinary M-protein by ≥90% or to <200 mg/24 hrs Stable disease: not response or progression"|At 3 and 12 months after auto-SCT|The Evaluable Analysis Set comprises all subjects who received at least 1 immunization with study drug and had a baseline and at least 1 post-baseline disease assessment.||participants|||Number
696155|NCT01380145|Secondary|Induction or Augmentation of MAGE-A3-Specific Cellular Immunity|Cellular immunity was determined by enzyme-linked immunosorbent spot assay (ELISPOT) or intracellular flow cytometry to determine peripheral blood levels of interferon gamma-producing CD4+ and CD8+ T cells specific for MAGE-A3. Results were considered significant if > 50 spots and > 2 times the number of spots to negative control were observed.|Baseline, first immunization, and first and second leukopheresis prior to auto-SCT; Days 31, 73, 194, 284, and 374 after auto-SCT|The Immunogenicity Analysis Set comprises all subjects who received at least 1 immunization with study drug and had a baseline and at least 1 post-baseline immunity assessment.||participants|||Number
696171|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-4)] of Naltrexone|AUC (0-4) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-4).|Pre-dose, 0.5, 1, 1.5, 2, 3 and 4 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.||hrs*pg/mL||Standard Deviation|Mean
697100|NCT01370369|Secondary|Frequency of Adverse Events (AEs)|The data were presented using descriptive statistics for this outcome.|From Baseline to Day 43|Safety Analysis Set population was used for this analysis, which comprised of all subjects who received at least one dose of the IMP.||number of event|||Number
696156|NCT01380145|Secondary|Induction or Augmentation of MAGE-A3-Specific Humoral Immunity|Humoral immunity was determined by enzyme-linked immunosorbent assay (ELISA) to measure the presence of circulating antibodies to MAGE-A3. Titers against an antigen were considered significant if they were >100. Induction of responses was considered significant if there was a change from undetectable (<100) to detectable (>100) or if there was an at least 4-fold increase in titers over time.|Baseline, first immunization, and first and second leukopheresis prior to auto-SCT; Days 31, 73, 194, 284, and 374 after auto-SCT|The Immunogenicity Analysis Set comprises all subjects who received at least 1 immunization with study drug and had a baseline and at least 1 post-baseline immunity assessment.||participants|||Number
696157|NCT01380145|Primary|Assessment of Safety of recMAGE-A3 + AS15|Analysis of treatment-emergent adverse events (TEAEs) reported from clinical laboratory tests, physical examinations, and vital signs, with severity graded according to the NCI CTCAE, Version 4.0.|Continuously for up to 14 months|The Safety Analysis Set comprises all subjects who received at least 1 immunization with study drug.||participants|||Number
696158|NCT01380093|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Naltrexone Metabolite (6-beta-naltrexol)|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.||hrs*pg/mL||Standard Deviation|Mean
696159|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)] of Naltrexone Metabolite (6-beta-naltrexol)|AUC (0-24) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-24).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.||hrs*pg/mL||Standard Deviation|Mean
696160|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-12)] of Naltrexone Metabolite (6-beta-naltrexol)|AUC (0-12) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-12).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.||hrs*pg/mL||Standard Deviation|Mean
696161|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-8)] of Naltrexone Metabolite (6-beta-naltrexol)|AUC (0-8) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-8).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.||hrs*pg/mL||Standard Deviation|Mean
696162|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-4)] of Naltrexone Metabolite (6-beta-naltrexol)|AUC (0-4) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-4).|Pre-dose, 0.5, 1, 1.5, 2, 3 and 4 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.||hrs*pg/mL||Standard Deviation|Mean
696163|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-2)] of Naltrexone Metabolite (6-beta-naltrexol)|AUC (0-2) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-2).|Pre-dose, 0.5, 1, 1.5 and 2 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.||hrs*pg/mL||Standard Deviation|Mean
696164|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-1)] of Naltrexone Metabolite (6-beta-naltrexol)|AUC (0-1) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-1).|Pre-dose, 0.5 and 1 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.||hrs*pg/mL||Standard Deviation|Mean
696165|NCT01380093|Secondary|Maximum Observed Plasma Concentration (Cmax) of Naltrexone Metabolite (6-beta-naltrexol)||Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.||pg/mL||Standard Deviation|Mean
696166|NCT01380093|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Naltrexone Metabolite (6-beta-naltrexol)||Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.||hrs||Standard Deviation|Mean
696167|NCT01380093|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Naltrexone|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.||hrs*pg/mL||Standard Deviation|Mean
696168|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)] of Naltrexone|AUC (0-24) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-24).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.||hrs*pg/mL||Standard Deviation|Mean
696169|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-12)] of Naltrexone|AUC (0-12) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-12).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.||hrs*pg/mL||Standard Deviation|Mean
696170|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-8)] of Naltrexone|AUC (0-8) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-8).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.||hrs*pg/mL||Standard Deviation|Mean
697240|NCT01369030|Secondary|Change in Overall Patient Satisfaction With Deplin® Using a 9-point Satisfaction Scale|"Mean satisfaction with medication was rated on 1 to 9 point scale, 1 indicating not at all satisfied and 9 as very satisfied."|Baseline to Endpoint (90 days)|||units on a scale||Full Range|Mean
696172|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-2)] of Naltrexone|AUC (0-2) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-2).|Pre-dose, 0.5, 1, 1.5 and 2 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.||hrs*pg/mL||Standard Deviation|Mean
696173|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-1)] of Naltrexone|AUC (0-1) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-1).|Pre-dose, 0.5 and 1 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.||hrs*pg/mL||Standard Deviation|Mean
696174|NCT01380093|Secondary|Maximum Observed Plasma Concentration (Cmax) of Naltrexone||Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.||pg/mL||Standard Deviation|Mean
696175|NCT01380093|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Naltrexone||Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.||hrs||Standard Deviation|Mean
696176|NCT01380093|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Morphine|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.||hrs*pg/mL||Standard Deviation|Mean
696177|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)] of Morphine|AUC (0-24) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-24).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.||hrs*pg/mL||Standard Deviation|Mean
696178|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-12)] of Morphine|AUC (0-12) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-12).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.||hrs*pg/mL||Standard Deviation|Mean
696179|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-8)] of Morphine|AUC (0-8) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-8).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.||hrs*pg/mL||Standard Deviation|Mean
696180|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-4)] of Morphine|AUC (0-4) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-4).|Pre-dose, 0.5, 1, 1.5, 2, 3 and 4 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.||hrs*pg/mL||Standard Deviation|Mean
696181|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-2)] of Morphine|AUC (0-2) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-2).|Pre-dose, 0.5, 1, 1.5 and 2 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.||hrs*pg/mL||Standard Deviation|Mean
696182|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-1)] of Morphine|AUC (0-1) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-1).|Pre-dose, 0.5 and 1 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.||hrs*pg/mL||Standard Deviation|Mean
696183|NCT01380093|Secondary|Maximum Observed Plasma Concentration (Cmax) of Morphine||Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.||picogram/milliliter (pg/mL)||Standard Deviation|Mean
696184|NCT01380093|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Morphine||Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.||hrs||Standard Deviation|Mean
696185|NCT01380093|Secondary|Pupillometry: Time to Maximum (Peak) Effect (TEmax)|Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. TEmax = Time to smallest post-dose pupil size.|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs||Standard Deviation|Mean
696186|NCT01380093|Secondary|Pupillometry: Peak Effect (Emax)|Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. Emax = Smallest post-dose pupil size.|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||mm||Standard Deviation|Mean
696197|NCT01380093|Secondary|Dizzy: Area Under Effect Curve (AUE) From 0-24 Hours|Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
696187|NCT01380093|Secondary|Pupillometry: Area Under Effect Curve (AUE) From 0-24 Hours|Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
696188|NCT01380093|Secondary|Pupillometry: Area Under Effect Curve (AUE) From 0-12 Hours|Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
696189|NCT01380093|Secondary|Pupillometry: Area Under Effect Curve (AUE) From 0-8 Hours|Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
696190|NCT01380093|Secondary|Pupillometry: Area Under Effect Curve (AUE) From 0-4 Hours|Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).|Pre-dose, 0.5, 1, 1.5, 2, 3 and 4 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
696191|NCT01380093|Secondary|Pupillometry: Area Under Effect Curve (AUE) From 0-2 Hours|Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).|Pre-dose, 0.5, 1, 1.5 and 2 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
696192|NCT01380093|Secondary|Pupillometry: Area Under Effect Curve (AUE) From 0-1 Hour|Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).|Pre-dose, 0.5 and 1 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
696193|NCT01380093|Secondary|Take Drug Again Effect at 24 Hours|Take drug again VAS is a subjective assessment of the degree to which a participant would desire to take the drug again if given the opportunity. It is presented on a 100 mm VAS with score ranging from 0 mm to 100 mm (score of 0 mm = “definitely would not”, 50 mm = “do not care”, and 100 mm = “definitely would”).|24 hrs post dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||mm||Standard Deviation|Mean
696194|NCT01380093|Secondary|Overall Drug Liking Effect at 24 Hours|Overall drug liking VAS assesses the participant’s global perception of drug liking (that is, effects over the whole course of the drug experience including any carryover effects). A 100 mm VAS is used to assess response based on a score ranging from 0 mm to 100 mm (0 mm = “strong disliking”, 50 mm= “neither like nor dislike”, and 100 mm= “strong liking”).|24 hrs post dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||mm||Standard Deviation|Mean
696195|NCT01380093|Secondary|Dizzy: Time to Maximum (Peak) Effect (TEmax)|Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs||Standard Deviation|Mean
696196|NCT01380093|Secondary|Dizzy: Peak Effect (Emax)|Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||mm||Standard Deviation|Mean
702057|NCT00075504|Secondary|Overall Survival||Up to 2 years|||months||95% Confidence Interval|Median
696198|NCT01380093|Secondary|Dizzy: Area Under Effect Curve (AUE) From 0-12 Hours|Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).|0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
696199|NCT01380093|Secondary|Dizzy: Area Under Effect Curve (AUE) From 0-8 Hours|Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).|0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
696200|NCT01380093|Primary|High: Peak Effect (Emax)|High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||mm||Standard Deviation|Mean
696201|NCT01380093|Secondary|Dizzy: Area Under Effect Curve (AUE) From 0-4 Hours|Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).|0.5, 1, 1.5, 2, 3 and 4 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
696202|NCT01380093|Secondary|Dizzy: Area Under Effect Curve (AUE) From 0-2 Hours|Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).|0.5, 1, 1.5 and 2 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
696203|NCT01380093|Secondary|Dizzy: Area Under Effect Curve (AUE) From 0-1 Hour|Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).|0.5 and 1 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
696204|NCT01380093|Secondary|Sleepy: Time to Maximum (Peak) Effect (TEmax)|Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs||Standard Deviation|Mean
696205|NCT01380093|Secondary|Sleepy: Peak Effect (Emax)|Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||mm||Standard Deviation|Mean
696206|NCT01380093|Secondary|Sleepy: Area Under Effect Curve (AUE) From 0-24 Hours|Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
696207|NCT01380093|Secondary|Sleepy: Area Under Effect Curve (AUE) From 0-12 Hours|Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).|0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
696208|NCT01380093|Secondary|Sleepy: Area Under Effect Curve (AUE) From 0-8 Hours|Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).|0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
696220|NCT01380093|Secondary|Nausea: Time to Maximum (Peak) Effect (TEmax)|Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs||Standard Deviation|Mean
696209|NCT01380093|Secondary|Sleepy: Area Under Effect Curve (AUE) From 0-4 Hours|Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).|0.5, 1, 1.5, 2, 3 and 4 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
696210|NCT01380093|Secondary|Sleepy: Area Under Effect Curve (AUE) From 0-2 Hours|Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).|0.5, 1, 1.5 and 2 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
696211|NCT01380093|Secondary|Sleepy: Area Under Effect Curve (AUE) From 0-1 Hour|Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr(0-1).|0.5 and 1 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
696212|NCT01380093|Secondary|Feel Sick: Time to Maximum (Peak) Effect (TEmax)|Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs||Standard Deviation|Mean
696213|NCT01380093|Secondary|Feel Sick: Peak Effect (Emax)|Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||mm||Standard Deviation|Mean
696214|NCT01380093|Secondary|Feel Sick: Area Under Effect Curve (AUE) From 0-24 Hours|Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
696215|NCT01380093|Secondary|Feel Sick: Area Under Effect Curve (AUE) From 0-12 Hours|Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).|0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
696216|NCT01380093|Secondary|Feel Sick: Area Under Effect Curve (AUE) From 0-8 Hours|Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).|0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
696217|NCT01380093|Secondary|Feel Sick: Area Under Effect Curve (AUE) From 0-4 Hours|Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).|0.5, 1, 1.5, 2, 3 and 4 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
696218|NCT01380093|Secondary|Feel Sick: Area Under Effect Curve (AUE) From 0-2 Hours|Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).|0.5, 1, 1.5 and 2 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
696219|NCT01380093|Secondary|Feel Sick: Area Under Effect Curve (AUE) From 0-1 Hour|Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).|0.5 and 1 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
696415|NCT01378429|Secondary|Change From Baseline in Urinary Free Cortisol-Uncorrected for Urine Creatinine||weeks 0-6|The PP population consisted of all ITT subjects who had sufficient blood sample collection at Visit 4/BL and Visit 7/End of Week 6 for serum cortisol measurements, completed the study on treatment medication and had no IPDs.||mcg/g||Standard Error|Least Squares Mean
696221|NCT01380093|Secondary|Nausea: Peak Effect (Emax)|Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||mm||Standard Deviation|Mean
696222|NCT01380093|Secondary|Nausea: Area Under Effect Curve (AUE) From 0-24 Hours|Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
696223|NCT01380093|Secondary|Nausea: Area Under Effect Curve (AUE) From 0-12 Hours|Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
696224|NCT01380093|Secondary|Nausea: Area Under Effect Curve (AUE) From 0-8 Hours|Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
696225|NCT01380093|Secondary|Nausea: Area Under Effect Curve (AUE) From 0-4 Hours|Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).|Pre-dose, 0.5, 1, 1.5, 2, 3 and 4 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
696226|NCT01380093|Secondary|Nausea: Area Under Effect Curve (AUE) From 0-2 Hours|Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).|Pre-dose, 0.5, 1, 1.5 and 2 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
696227|NCT01380093|Secondary|Nausea: Area Under Effect Curve (AUE) From 0-1 Hour|Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).|Pre-dose, 0.5 and 1 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
696228|NCT01380093|Secondary|Bad Effects: Time to Maximum (Peak) Effect (TEmax)|Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs||Standard Deviation|Mean
696229|NCT01380093|Secondary|Bad Effects: Peak Effect (Emax)|Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||mm||Standard Deviation|Mean
696230|NCT01380093|Secondary|Bad Effects: Area Under Effect Curve (AUE) From 0-24 Hours|Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
696231|NCT01380093|Secondary|Bad Effects: Area Under Effect Curve (AUE) From 0-12 Hours|Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).|0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
696416|NCT01378429|Secondary|Change From Baseline in Urinary Free Cortisol-Corrected for Urine Creatinine||weeks 0-6|The PP population. Subjects with either missing baseline data or post dose data, or both were not included in the analysis||mcg/g||Standard Error|Least Squares Mean
697241|NCT01369030|Secondary|Proportion of Patients Reporting Difficulty in Daily Functioning Due to Depressive Symptoms||Baseline to Endpoint (90 days)|||percentage of participants|||Number
696232|NCT01380093|Secondary|Bad Effects: Area Under Effect Curve (AUE) From 0-8 Hours|Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).|0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
696233|NCT01380093|Secondary|Bad Effects: Area Under Effect Curve (AUE) From 0-4 Hours|Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).|0.5, 1, 1.5, 2, 3 and 4 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
696234|NCT01380093|Secondary|Bad Effects: Area Under Effect Curve (AUE) From 0-2 Hours|Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).|0.5, 1, 1.5 and 2 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
696235|NCT01380093|Secondary|Bad Effects: Area Under Effect Curve (AUE) From 0-1 Hour|Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).|0.5 and 1 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
696236|NCT01380093|Secondary|Any Effects: Time to Maximum (Peak) Effect (TEmax)|Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs||Standard Deviation|Mean
696237|NCT01380093|Secondary|Any Effects: Peak Effect (Emax)|Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||mm||Standard Deviation|Mean
696238|NCT01380093|Secondary|Any Effects: Area Under Effect Curve (AUE) From 0-24 Hours|Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
696239|NCT01380093|Secondary|Any Effects: Area Under Effect Curve (AUE) From 0-12 Hours|Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).|0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
696240|NCT01380093|Secondary|Any Effects: Area Under Effect Curve (AUE) From 0-8 Hours|Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).|0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
696241|NCT01380093|Secondary|Any Effects: Area Under Effect Curve (AUE) From 0-4 Hours|Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).|0.5, 1, 1.5, 2, 3 and 4 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
696242|NCT01380093|Secondary|Any Effects: Area Under Effect Curve (AUE) From 0-2 Hours|Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).|0.5, 1, 1.5 and 2 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
696462|NCT01378065|Primary|Palpability of the Restorelle Direct Fix A&P|Measured via palpability scale with possible outcomes of none, mild, moderate, or severe.|3 months|All study subjects||participants|||Number
696463|NCT01378065|Primary|Palpability of the Restorelle Direct Fix A&P|Measured via palpability scale with possible outcomes of none, mild, moderate, or severe.|6 weeks|All subjects||participants|||Number
696243|NCT01380093|Secondary|Any Effects: Area Under Effect Curve (AUE) From 0-1 Hour|Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).|0.5 and 1 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
696244|NCT01380093|Secondary|Good Effects: Time to Maximum (Peak) Effect (TEmax)|Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs||Standard Deviation|Mean
696245|NCT01380093|Secondary|Good Effects: Peak Effect (Emax)|Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||mm||Standard Deviation|Mean
696246|NCT01380093|Secondary|Good Effects: Area Under Effect Curve (AUE) From 0-24 Hours|Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
696247|NCT01380093|Secondary|Good Effects: Area Under Effect Curve (AUE) From 0-12 Hours|Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).|0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
696248|NCT01380093|Secondary|Good Effects: Area Under Effect Curve (AUE) From 0-8 Hours|Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).|0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
696249|NCT01380093|Secondary|Good Effects: Area Under Effect Curve (AUE) From 0-4 Hours|Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).|0.5, 1, 1.5, 2, 3 and 4 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
696250|NCT01380093|Secondary|Good Effects: Area Under Effect Curve (AUE) From 0-2 Hours|Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).|0.5, 1, 1.5 and 2 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
696251|NCT01380093|Secondary|Good Effects: Area Under Effect Curve (AUE) From 0-1 Hour|Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).|0.5 and 1 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
696252|NCT01380093|Secondary|High: Time to Maximum (Peak) Effect (TEmax)|High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs||Standard Deviation|Mean
696253|NCT01380093|Secondary|High: Area Under Effect Curve (AUE) From 0-24 Hours|High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
696478|NCT01377636|Other Pre-specified|Number of Participants With Significant Change in Heart Rate|Heart rate measured by standard EKG monitor during anesthesia. Pre- and Post Heart rates where noted. An increase of 8 percent or more was defined as a significant change in heart rate.|Within 20 minutes of starting isoproterenol infusion|||participants|||Number
696254|NCT01380093|Secondary|High: Area Under Effect Curve (AUE) From 0-12 Hours|High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).|0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
696255|NCT01380093|Secondary|High: Area Under Effect Curve (AUE) From 0-8 Hours|High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).|0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
696256|NCT01380093|Secondary|High: Area Under Effect Curve (AUE) From 0-4 Hours|High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).|0.5, 1, 1.5, 2, 3 and 4 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
696257|NCT01380093|Secondary|High: Area Under Effect Curve (AUE) From 0-1 Hour|High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).|0.5 and 1 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
696258|NCT01380093|Secondary|Drug Liking: Time to Maximum (Peak) Effect (TEmax)|"Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of neither like nor dislike (score of 50 mm), on the left with strong disliking (score of 0 mm) and on the right with strong liking (score of 100 mm). TEmax = Time to maximum observed score."|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs||Standard Deviation|Mean
696259|NCT01380093|Secondary|Drug Liking: Area Under Effect Curve (AUE) From 0-24 Hours|"Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of neither like nor dislike (score of 50 mm), on the left with strong disliking (score of 0 mm) and on the right with strong liking (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24)."|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
696260|NCT01380093|Secondary|Drug Liking: Area Under Effect Curve (AUE) From 0-12 Hours|"Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of neither like nor dislike (score of 50 mm), on the left with strong disliking (score of 0 mm) and on the right with strong liking (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12)."|0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
696261|NCT01380093|Secondary|Drug Liking: Area Under Effect Curve (AUE) From 0-8 Hours|"Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of neither like nor dislike (score of 50 mm), on the left with strong disliking (score of 0 mm) and on the right with strong liking (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8)."|0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
696262|NCT01380093|Secondary|Drug Liking: Area Under Effect Curve (AUE) From 0-4 Hours|"Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of neither like nor dislike (score of 50 mm), on the left with strong disliking (score of 0 mm) and on the right with strong liking (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4)."|0.5, 1, 1.5, 2, 3 and 4 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
696263|NCT01380093|Secondary|Drug Liking: Area Under Effect Curve (AUE) From 0-1 Hour|"Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of neither like nor dislike (score of 50 mm), on the left with strong disliking (score of 0 mm) and on the right with strong liking (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1)."|0.5 and 1 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
696264|NCT01380093|Primary|High: Area Under Effect Curve (AUE) From 0-2 Hours|High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).|0.5, 1, 1.5 and 2 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
696265|NCT01380093|Primary|Drug Liking: Peak Effect (Emax)|"Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of neither like nor dislike (score of 50 mm), on the left with strong disliking (score of 0 mm) and on the right with strong liking (score of 100 mm). Emax = Maximum observed score."|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||mm||Standard Deviation|Mean
696266|NCT01380093|Primary|Drug Liking: Area Under Effect Curve (AUE) From 0-2 Hours|"Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 millimeter (mm) bipolar visual analogue scale (VAS) anchored in the center with a neutral anchor of neither like nor dislike (score of 50 mm), on the left with strong disliking (score of 0 mm) and on the right with strong liking (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hours (hrs) (0-2)."|0.5, 1, 1.5 and 2 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose pharmacodynamic (PD) data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
696267|NCT01380080|Secondary|Proportion of Participants Who Prematurely Discontinued Antiretroviral Therapy by Week 48|Proportion of participants with premature discontinuation of antiretroviral therapy (ART) by Week 48|From study entry to week 48||12/2020||||
696268|NCT01380080|Secondary|Proportion of Participants Who Prematurely Discontinued Any Component of TB Treatment by Week 48|Proportion of participants with premature discontinuation of any component of TB treatment by Week 48|From study entry to week 48||12/2020||||
696269|NCT01380080|Secondary|Proportion of Participants With Reportable Hospitalization by Week 48|Proportion of participants with any hospitalization reported by Week 48|From study entry to week 48||12/2020||||
696270|NCT01380080|Secondary|Proportion of Participants With IRIS (Using Current ACTG Definition) by Week 48|Proportion of participants with IRIS (using current ACTG definition Appendix 60) by Week 48|From study entry to week 48||12/2020||||
696271|NCT01380080|Secondary|Proportion of Participants With at Least One New Grade 3 or 4 That is at Least a One-grade Increase From Baseline for the Following Targeted Laboratory Values by Week 48|"Proportion of participants with at least one new Grade 3 or 4 that is at least a one-grade increase from baseline for the following targeted laboratory values by Week 48
The targeted laboratory events include hemoglobin, serum creatinine, ALT and AST"|From study entry to week 48||12/2020||||
696272|NCT01380080|Secondary|Proportion of Participants With at Least One New Grade 3 or 4 Adverse Event That is at Least a One-grade Increase From Baseline by Week 48|Proportion of participants with at least one new Grade 3 or 4 laboratory or sign or symptom that is at least a one-grade increase from baseline by Week 48|From study entry to week 48||12/2020||||
696273|NCT01380080|Secondary|Proportion of Participants With TB Diagnosis Per Current ACTG Diagnosis Appendix by Week 96|Proportion of participants with TB diagnosis per current ACTG Diagnosis Appendix 60 by week 96|From study entry to week 96||12/2020||||
696274|NCT01380080|Secondary|Time to Initiation of TB Treatment by Week 96|Median time to TB treatment initiation by week 96|From study entry to week 96||12/2020||||
696275|NCT01380080|Secondary|CD4+ T-cell Count Change From Baseline|Change was calculated as the CD4+ T-cell count at week (4 and 24) minus the baseline CD4+ T-cell count. The results at week 48 will be submitted after the study is completed|From study entry to weeks 4, 24 and 48|Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment. Missing data were assumed missing completely at random.||cells/ mm^3||Inter-Quartile Range|Median
696276|NCT01380080|Secondary|CD4+ T-cell Count|The absolute levels of CD4+ T-cell counts (cells/mm^3) at weeks 0, 4, and 24. The results at week 48 will be submitted after the study is completed|At weeks 0, 4, 24, and 48|Intent to treat: All eligible participants were included in the analysis: Participants were analyzed per original assigned randomized treatment. Missing data were assigned missing completely at random.||cells/ mm^3||Inter-Quartile Range|Median
696277|NCT01380080|Secondary|Proportion of Participants With HIV-1 RNA Level <400 Copies/mL|Proportion of participants with HIV-1 RNA level <400 copies/mL at weeks 0, 4, and 24. The results at week 48 will be submitted after the study is completed|At weeks 0, 4, 24, and 48|Intent to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment. Missing data were assumed missing completed at random||Proportion of participants||95% Confidence Interval|Number
696278|NCT01380080|Secondary|Cumulative Probability of Death or AIDS Progression by Week 24|"The Kaplan-Meier estimate of the cumulative probability of death or AIDS progression by week 24
The result of cumulative probability of death or AIDS progression by week 48 will be submitted after the study is completed. AIDS progression was defined as new WHO stage 3 or 4 conditions occurred after study entry."|From study entry to week 24|Intent to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment||Cumulative probablity per 100 persons||95% Confidence Interval|Number
696279|NCT01380080|Secondary|Cumulative Probability of First AIDS Progression by Week 96|The Kaplan-Meier estimate of the cumulative probability of first AIDS progression which was defined as the identification of a new World Health Organization (WHO) stage 3 or 4 condition|From study entry to week 96||12/2020||||
696280|NCT01380080|Secondary|Cumulative Probability of Death by Week 24|The Kaplan-Meier estimate of cumulative probability of death by week 24|From study entry to week 24|Intent to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment||Cumulative probablity per 100 persons||95% Confidence Interval|Number
696281|NCT01380080|Primary|Cumulative Probability of Death or Unknown Vital Status by Week 24|"The Kaplan-Meier estimate of the cumulative probability of death or unknown vital status by week 24.
Vital status at week 48 and again at weeks 60, 72, 84, and 96 was determined for participants who do not complete study follow-up, including those who are prematurely discontinued from the study before week 24 without coming in to the clinic. Vital status for participants who are not discontinued from the study whenever a scheduled visit of any type is missed was also obtained. The vital status was considered unknown at week 24 if a participant prematurely discontinued from the study before week 24 and no vital status was obtained at week 48."|From study entry to week 24|Intent to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment||Cumulative probablity per 100 persons||95% Confidence Interval|Number
696282|NCT01379963|Secondary|Percentage of Participants Who Achieved a 6-month Hemoglobin Level Stabilization in the Range of 11-12 g/dL|Hemoglobin level Level stabilization within the range of 11-12 g/dL was measured on a monthly basis according to KDOQI guidelines, for enrolled participants who had received methoxy-polyethylene-glycol-epoetin beta treatment.|Up to 6 months|Analysis population included all enrolled participants who had received study treatment and were monitored for hemoglobin level on a monthly basis, according to standard clinical practice. Here, number of participants analyzed signifies those participants who were evaluable for this outcome.||Percentage of participants|||Number
696283|NCT01379963|Primary|Percentage of Participants Who Achieved a 3-month Hemoglobin Level Stabilization in the Range of 11-12 Grams Per Deciliter (g/dL)|Hemoglobin level stabilization within the range of 11-12 g/dL was measured on a monthly basis according to Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines, for enrolled participants who had received methoxy-polyethylene-glycol-epoetin beta treatment.|Up to 6 months|Analysis population included all enrolled participants who had received study treatment and were monitored for hemoglobin level on a monthly basis, according to standard clinical practice. Here, number of participants analyzed signifies those participants who were evaluable for this outcome.||Percentage of participants|||Number
696284|NCT01379937|Secondary|Number of Subjects With Booster Vaccine Response for H5N1 Neutralizing Antibodies|This outcome concerns solely subjects in the GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group as required by the protocol.|At Days 192 and 364|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.||Subjects|||Number
696285|NCT01379937|Secondary|Number of Subjects With Vaccine Response Rates (VRR) for H5N1 Neutralizing Antibodies||At Days 42, 182 192 and 364|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.||Subjects|||Number
696286|NCT01379937|Secondary|Number of Subjects With Neutralizing Anti-H5N1 Antibody Titers|"Seropositivity rates against the A/Indonesia/5/2005 (H5N1 virus) strain, were tabulated on Days 0,42,182 for all subjects, 192 for GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group, GSK1562902A Formulation 2 - Havrix / Havrix Jr Group and 364 for GSK1562902A Formulation 1 - Havrix / Havrix Jr Group and GSK1562902A Formulation 1 - Havrix / Havrix Jr Group.
Seropositivity rates against the A/turkey/Turkey/01/2005 (H5N1 virus) strain, were tabulated on Days 0, 42,182, 192 and 364."|At Days 0, 42, 182 192 and 364|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.||Subjects|||Number
696287|NCT01379937|Secondary|Booster Factor for Hemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/01/2005 Strain of H5N1 Influenza Disease|Boooster factor against the A/turkey/Turkey/01/2005 (H5N1 VIRUS) strain were tabulated 95% CI on Days 192,364. This outcome concerns solely subjects in the GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group as required by the protocol.|At Days 192 and 364|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.||Titer||95% Confidence Interval|Geometric Mean
696288|NCT01379937|Secondary|Number of Seroconverted Subjects Against the A/Turkey/Turkey/01/2005 Strains of H5N1 Influenza Disease|"Booster seroconversion rates against the A/turkey/Turkey/01/2005 (H5N1 VIRUS) strain were tabulated on Days 192 and 364.
This outcome concerns solely subjects in the GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group as required by the protocol."|At Days 192 and 364|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.||Subjects|||Number
696289|NCT01379937|Secondary|Mean Geometric Increase for Anti-H5N1 Antibody Titers|"MGI against the A/Indonesia/05/2005 (H5N1 VIRUS) strain were tabulated on Days 0,42,182 for all subjects, 192 for GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group, GSK1562902A Formulation 2 - Havrix / Havrix Jr Group and 364 for GSK1562902A Formulation 1 - Havrix / Havrix Jr Group and GSK1562902A Formulation 1 - Havrix / Havrix Jr Group.
MGI against the A/turkey/Turkey/01/2005 (H5N1 virus) strain were tabulated on Days 42, 182 and 364."|At Days 42, 182, 192 and 364|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.||Titer||95% Confidence Interval|Geometric Mean
696479|NCT01377636|Secondary|Number of Participants Who Follow Verbal Command to Squeeze Hands|"Increasing doses of isoproterenol (5,10,15,20 mcg/minute) were administered to patients undergoing catheter ablation for atrial fibrillation. Ability to follow verbal commands before and after isoproterenol infusion was assessed by asking subjects to squeeze my hands."|Within 20 minutes of starting isoproterenol infusion|||participants|||Number
696290|NCT01379937|Secondary|Number of Seroprotected Subjects Against the A/Indonesia/05/2005 and A/Turkey/Turkey/01/2005 Strains of H5N1 Influenza Disease|"A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.
Seroprotection rates against the A/Indonesia/5/2005 (H5N1 virus) strain, were tabulated 95% CI on Days 0,42,182 for all subjects, 192 for GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group, GSK1562902A Formulation 2 -Havrix / Havrix Jr Group and 364 for GSK1562902A Formulation 1 - Havrix / Havrix Jr Group and GSK1562902A Formulation 1 - Havrix / Havrix Jr Group.
Seroprotection rates against the A/turkey/Turkey/01/2005 (H5N1 virus) strain, were tabulated on Days 182 and 192."|At Days 0,42, 182, 192 and 364|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.||Subjects|||Number
696291|NCT01379937|Secondary|Number of Seroconverted Subjects Against the A/Indonesia/05/2005 Strains of H5N1 Influenza Disease|"A seroconverted subject was defined as a vaccinee with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.
Seroconversion rates against the A/Indonesia/05/2005 (H5N1 VIRUS) strain were tabulated on Days 0,42,182 for all subjects, 192 for GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group, GSK1562902A Formulation 2 - Havrix / Havrix Jr Group and 364 for GSK1562902A Formulation 1 - Havrix / Havrix Jr Group and GSK1562902A Formulation 1 - Havrix / Havrix Jr Group."|At Days 42, 182, 192 and 364|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.||Subjects|||Number
696292|NCT01379937|Secondary|Number of Subjects With Anti-H5N1 Antibodies Above the Cut Off Values ≥1:10|"Seropositivity rates against the A/Indonesia/5/2005 (H5N1 virus) strain, were tabulated on Days 0,42,182 for all subjects, 192 for GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group, GSK1562902A Formulation 2 - Havrix / Havrix Jr Group and 364 for GSK1562902A Formulation 1 - Havrix / Havrix Jr Group and GSK1562902A Formulation 1 - Havrix / Havrix Jr Group.
Seropositivity rates against the A/turkey/Turkey/01/2005 (H5N1 virus) strain, were tabulated on Days 182, 192 and 364."|At Days 0, 42, 182, 192 and 364|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.||Subjects|||Number
696293|NCT01379937|Secondary|Number of Subjects With Serious Adverse Events (SAEs).|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (Day 0 to 364)|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.||Subjects|||Number
696294|NCT01379937|Secondary|Number of Subjects With Any Potential Immune-Mediated Diseases (pIMDs)||During the entire study period (Day 0 to 364)|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.||Subjects|||Number
696295|NCT01379937|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During Day 0 to Telephone Contact (TC) Day 84 overall.|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.||Subjects|||Number
696296|NCT01379937|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During a 21-day (Days 0 – 20) follow-up period after vaccination|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.||Subjects|||Number
696297|NCT01379937|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.|Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia and temperature[defined as axillary temperature equal to or above 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. The symptoms were assessed for subjects aged 6 years or more.|During a 7-day (Day 0-6) follow-up period after vaccination|The analysis was based on subjects aged 6 years or more, comprised in the Total vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.||Subjects|||Number
696298|NCT01379937|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.|Assessed solicited general symptoms were diarrhea/vomiting, drowsiness, irritability/fussiness, loss of appetite and temperature [defined as axillary temperature equal to or above 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. The symptoms were assessed for subjects aged less than 6 years.|During a 7-day (Day 0-6) follow-up period after each vaccination|The analysis was based on subjects aged less than 6 years, comprised in the Total vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.||Subjects|||Number
696299|NCT01379937|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Relationship analysis was not performed.|During a 7-day (Day 0-6) follow-up period after each vaccination|The analysis was based on the Total vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.||Subjects|||Number
696300|NCT01379937|Secondary|H5N1 HI Neutralizing Antibody Titres Against the A/Indonesia/5/2005 and A/Turkey/Turkey/01/2005 (H5N1 Virus) Strains|Antibody titers were given as GMTs. A/Indonesia/5/2005 = A/INDO and A/Turkey/Turkey/01/2005 = A/TURK.|At Days 0, 42, 182, 192, 364|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.||Titer||95% Confidence Interval|Geometric Mean
696301|NCT01379937|Secondary|H5N1 HI Antibody Titres Against the A/Indonesia/5/2005 and A/Turkey/Turkey/01/2005 (H5N1 Virus) Strains|The antibody titres were given as Geometric Mean Titer (GMT). A/Indonesia/5/2005 = A/INDO and A/Turkey/Turkey/01/2005 = A/TURK.|At Days 0, 42, 182, 192, 364|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.||Titer||95% Confidence Interval|Geometric Mean
696302|NCT01379937|Primary|Number of Subjects With Any Medically Attended Adverse Events (MAEs)|Any = occurrence of the symptom regardless of intensity grade.|From Day 0 to Day 364.|The analysis was based on the Total vaccinated Cohort, which included all subjects with at least 1 vaccine administration documented.||Subjects|||Number
696303|NCT01379937|Primary|Number of Subjects With Any Medically Attended Adverse Events (MAEs)|Any = occurrence of the symptom regardless of intensity grade. This outcome concerns solely subjects in the GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group as required by the protocol.|From Day 0 to Day 182|The analysis was based on the Total vaccinated Cohort, which included all subjects with at least 1 vaccine administration documented.||Subjects|||Number
696304|NCT01379937|Primary|Haemagglutination Inhibition (HI) Antibody Titers for the A/Turkey/Turkey/01/2005 (H5N1) Vaccine Strain.|Antibody titers were expressed as Geometric mean titers (GMTs). The H5N1 vaccine strain included A/Turkey/Turkey/01/2005 antigen. The A/Turkey/Turkey/01/2005 (A/TURK) vaccine strain was administered to groups receiving the adjuvanted Influenza vaccine GSK1562902A. This outcome concerns solely subjects in the GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group as required by the protocol.|At Day 192.|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.||Titer||95% Confidence Interval|Geometric Mean
696305|NCT01379781|Primary|Hamilton Rating Scales of Depression|"Assessing severity of depression; clinician rated
24 questions
13 items are scored on a 5 point scale ranging from 0=not present to 4=severe
11 items are scored from 0-2
A composite score is created by the sum of the scores from all items. Scores can range from 0-74
0-7: normal
8-13: mild depression
14-18: moderate depression
19-23: severe depression
24: very severe depression
Higher summed values indicate a greater severity of depression"|6 weeks postpartum|Those in the analysis received both baseline and 6-week assessment sessions.||units on a scale||Standard Deviation|Mean
696306|NCT01379768|Primary|Change From Week 1 in Relative Oxidative Response of PMNs at Week 5|A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA) and analyzed on a flow cytometer. Oxidative response is reported as a ratio of activated to non-activated samples. The difference between the ratio data for contact lens wearers and non-lens wearers (Week 5 minus Week 1) is presented.|Week 1, Week 5|This reporting group includes all participants who completed the study per protocol.||Ratio||Standard Deviation|Mean
696307|NCT01379768|Primary|Change From 1 Week in Relative Cell Adhesion Response of PMNs at Week 5|A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA) and analyzed on a flow cytometer. Cell adhesion response is reported as a ratio of activated to non-activated samples. The difference between the ratio data for contact lens wearers and non-lens wearers (Week 5 minus Week 1) is presented.|Week 1, Week 5|This reporting group includes all participants who completed the study per protocol.||Ratio||Standard Deviation|Mean
696308|NCT01379768|Primary|Change From Week 1 in Leukocyte Population at Week 5|A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA). Different types of white blood cells (leukocytes) were identified, which included neutrophils, monocytes, and lymphocytes. The difference between total leukocytes for contact lens wearers and non-lens wearers (Week 5 minus Week 1) is presented.|Week 1, Week 5|This reporting group includes all participants who completed the study per protocol.||Leukocytes||Standard Deviation|Mean
696309|NCT01379768|Primary|Relative Oxidative Response of Polymorphonuclear Leukocytes (PMNs)|A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA) and analyzed on a flow cytometer. Oxidative response is reported as a ratio of activated to non-activated samples. DCF (dichlorofluorescein diacetate) is a molecular probe that measures the oxidative burst. Upon stimulation, the PMNs synthesize reactive oxygen species, such as superoxide or hydrogen peroxide, which is detected by the probe. Differences in the oxidative response between contact lens wearers and non-lens wearers is indicated by a shift in the ratio (stimulated/unstimulated).|Week 5|This reporting group includes all participants who completed the study per protocol.||Ratio||Standard Deviation|Mean
696310|NCT01379768|Primary|Relative Cell Adhesion Response of Polymorphonuclear Leukocytes (PMNs)|A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA) and analyzed on a flow cytometer. CD54 is a protein typically found in the cell membrane of leukocytes, which up-regulates during inflammation and promotes cell adhesion. Cell adhesion response is reported as a ratio of stimulated to non-stimulated samples.|Week 5|This reporting group includes all participants who completed the study per protocol.||Ratio||Standard Deviation|Mean
696311|NCT01379768|Primary|Leukocyte Population|A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA). Different types of white blood cells (leukocytes) were identified, which included neutrophils, monocytes, and lymphocytes. The total amount of leukocytes for contact lens wearers and non-lens wearers is presented. Potential differences in leukocyte count between lens wearers and non-lens wearers may indicate a different immune response.|Week 5|This reporting group includes all participants who completed the study per protocol.||Leukocytes||Standard Deviation|Mean
696312|NCT01379703|Secondary|Adverse Events Observed on Treatment With Lopinavir/Ritonavir.|"Total number of adverse events with causal relationship (rated by Investigator as probably or possibly related) to lopinavir/ritonavir treatment.
All serious adverse events and non serious adverse events (0.2% or greater frequency) are summarized in the Reported Adverse Events section of this record."|18 months|||Events|||Number
696313|NCT01379703|Secondary|Compliance With Lopinavir/Ritonavir|Participants reported whether they had missed any doses of their antiretroviral treatment.|18 months|Only participants receiving lopinavir/ritonavir capsules for followed for up to 18 months.||Participants|||Number
696314|NCT01379703|Secondary|Compliance With Lopinavir/Ritonavir|Participants reported whether they had missed doses of their antiretroviral treatment.|9 months|||Participants|||Number
696315|NCT01379703|Secondary|Reasons for Discontinuation of Lopinavir/Ritonavir|For participants who discontinued lopinavir/ritonavir treatment, the reasons for discontinuation are provided.|18 months|Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months.||Participants|||Number
696316|NCT01379703|Secondary|Reasons for Discontinuation of Lopinavir/Ritonavir|For participants who discontinued lopinavir/ritonavir treatment, the reasons for discontinuation are provided.|9 months|||Participants|||Number
696317|NCT01379703|Primary|Laboratory Parameter Lipids|A blood lipid panel consisting of total cholesterol, triglyceride, high-density lipoprotein (HDL), and low-density lipoprotein (LDL) levels was performed at baseline and scheduled study visits. Normal ranges are based on the standards for individual facilities in each country.|Baseline, 9 months, 18 months|Analysis was based on participants with laboratory values at each time point. Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months.||millimoles per liter||Standard Deviation|Mean
696318|NCT01379703|Primary|Laboratory Parameter Transaminases|Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory values were assessed at baseline and scheduled study visits. Normal ranges are based on the standards for individual facilities in each country.|Baseline, 9 months, 18 months|Analysis was based on participants with laboratory values at each time point. Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months.||international units per liter||Standard Deviation|Mean
696319|NCT01379703|Primary|Laboratory Parameter Blood Glucose|Blood glucose laboratory values were assessed at baseline and scheduled study visits. Normal ranges are based on the standards for individual facilities in each country.|Baseline, 9 months, 18 months|Analysis was based on participants with laboratory values at each time point. Only participants receiving lopinavir/ritonavir capsules were planned to be followed after 9 months.||millimoles per liter||Standard Deviation|Mean
696320|NCT01379703|Primary|Viral Load|Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.|18 months|Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months. Change from baseline analysis is based on last observation carried forward (N=660).||Log10 copies per ml||Standard Deviation|Mean
696321|NCT01379703|Primary|Viral Load|Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.|15 months|Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months.||Log10 copies per ml||Standard Deviation|Mean
696322|NCT01379703|Primary|Viral Load|Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.|12 months|Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months.||Log10 copies per ml||Standard Deviation|Mean
696323|NCT01379703|Primary|Viral Load|Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.|9 months|Change from baseline analysis is based on last observation carried forward for total study population (N=1341) and tablet formulation group (N=677).||Log10 copies per ml||Standard Deviation|Mean
696324|NCT01379703|Primary|Viral Load|Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.|6 months|||Log10 copies per ml||Standard Deviation|Mean
696325|NCT01379703|Primary|Viral Load|Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.|3 months|||Log10 copies per ml||Standard Deviation|Mean
696326|NCT01379703|Primary|Viral Load|Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.|1 month|||Log10 copies per ml||Standard Deviation|Mean
696327|NCT01379703|Primary|Viral Load|Viral load is a direct measure of the viral burden by providing a count of the number of HIV-RNA copies in blood (plasma). The number of HIV-RNA copies in the blood was measured at baseline.|Baseline|Mean viral load is based on number of participants in each group who had laboratory results for viral load at baseline.||Log10 copies per ml||Standard Deviation|Mean
696328|NCT01379703|Primary|Changes in CD4 Count|Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.|Baseline to 18 months|Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months. Change from baseline analysis is based on participants receiving capsule formulation with CD4 count results available at 18 months.||cells per mm³||Standard Deviation|Mean
710607|NCT00165698|Primary|Bone Mineral Density BMD (Percentage) Change in Lumber Spine After 12 Months||Baseline and 12 months|Per Protocol Set (PPS)||percentage of BMD||Full Range|Median
696329|NCT01379703|Primary|Changes in CD4 Count|Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.|Baseline to 15 months|Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months. Change from baseline analysis is based on participants receiving capsule formulation with CD4 count results available at 15 months.||cells per mm³||Standard Deviation|Mean
696330|NCT01379703|Primary|Changes in CD4 Count|Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.|Baseline to 12 months|Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months. Change from baseline analysis is based on participants receiving capsule formulation with CD4 count results available at 12 months.||cells per mm³||Standard Deviation|Mean
696331|NCT01379703|Primary|Changes in CD4 Count|Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.|Baseline to 9 months|Change from baseline analysis is based on participants with CD4 count results available at 9 months.||cells per mm³||Standard Deviation|Mean
696332|NCT01379703|Primary|Changes in CD4 Count|Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.|Baseline to 6 months|Change from baseline analysis is based on participants with CD4 count results available at 6 months.||cells per mm³||Standard Deviation|Mean
696333|NCT01379703|Primary|Changes in CD4 Count|Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.|Baseline to 3 months|Change from baseline analysis is based on participants with CD4 count results available at 3 months.||cells per mm³||Standard Deviation|Mean
696334|NCT01379703|Primary|Changes in CD4 Count|Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.|Baseline to 1 month|Change from baseline analysis is based on participants with CD4 count results available at 1 month.||cells per mm³||Standard Deviation|Mean
696335|NCT01379703|Primary|CD4 Count|CD4 lymphocyte count is a measure of a participant's immunologic health. Participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the number of CD4+ cells at baseline.|Baseline|Mean CD4 count is based on number of participants in each group who had CD4 count results at Baseline.||cells per mm³||Standard Deviation|Mean
696336|NCT01379664|Secondary|Total Intraoperative Opioid Consumption|Total amount of opioid in IV morphine equivalents used during surgeyr|intraoperative|||mg||Standard Deviation|Mean
696337|NCT01379664|Secondary|Time-weighted Average Verbal Rating Pain Score|Time-weighted average VRS (Verbal Rating Scale) pain score over the first 72 h after surgery as recorded by nurses at approximately 4-h intervals. The VRS pain score is from 0 (no pain) to 10 (worst imaginable pain).|up to 72 hours after surgery|Postoperative pain measurements were not available for 19 isoflurane patients and 20 sevoflurane patients.||units on a scale||Standard Deviation|Mean
696338|NCT01379664|Primary|Hospital Length of Stay||participants will be followed for the duration of hospital stay, an expected average of 3 days|||Days||Inter-Quartile Range|Median
696339|NCT01379651|Secondary|Changes in the Median Weal Diameter, Using Egg White SPTs, End-point SPT and PP|Before and after SOTI, we evaluated the change in the median weal diameter in millimeters, using egg white SPTs, end-point SPT and PP.|Baseline and 6 months|We were unable to calculate sample size because no quantitative data about the clinical outcome could be hypothesized. Indeed, the few reports of food causing allergy, the protocol, the way of SOTI administration and food doses administered yielded reported variable results. the analysis was per intention to treat||mm diameter||Full Range|Median
696340|NCT01379651|Primary|Number of Children That Achieved Total (40 ml) or Partial (Less Than 40 ml But at Least 10 ml) Tolerance to Raw Egg|To evaluate the efficacy of a 6-month Specific Oral Tolerance Induction (SOTI) protocol in inducing tolerance (maximal dose of raw egg emulsion tolerated after 6 months) in children with severe IgE-mediated egg allergy and a history of at least 1 anaphylactic reaction after accidental exposure to egg.|baseline and 6 months|||participants|||Number
696341|NCT01379625|Secondary|Exercise Heart Rate|Subjects will complete a submaximal treadmill exercise study at baseline. Exercise heart heart, ventilation and perceived exertion will be measured. Subjects will be randomized to MCT or triheptanoin supplementation for 4 months. At the end of treatment, the exercise test will be repeated keeping work performed constant. Change in exercise heart rate, ventilation and exertion will be compared between groups.|change from baseline to 4 months of treatment|||beats per minute||Standard Deviation|Mean
696342|NCT01379625|Primary|Ejection Fraction|Change in resting ejection fraction over 4 month treatment period|4 months|Change in resting ejection fraction over 4 month treatment period calculated as: 4 month ejection fraction-baseline ejection fraction. Only participants with available data are included in this analysis.||percent||Standard Deviation|Mean
696343|NCT01379625|Primary|Energy Expenditure|Total energy expenditure will be measured by doubly labeled water and resting energy expenditure will be measured by indirect calorimetry at baseline and again after 4 months of either MCT or trihpetanoin treatment.|change from baseline after 4 months of treatment|One subject in each group did not complete the doubly labeled water measures. A total of 15 in each group measured total energy expenditure at baseline and at the end of the study. This value compares the change over treatment.||kcal/day||Standard Deviation|Mean
696344|NCT01379534|Secondary|Number of Participants With Adverse Events, Serious Adverse Events and Deaths|Adverse event monitoring was conducted throughout the study.|up to 30 days after the last dose of study drug, up to 18 weeks|Safety analysis set: The safety set included all participants who received at least one dose of study medication.||Participants|||Number
696345|NCT01379534|Secondary|Progression Free Survival (PFS)|PFS was defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause. If a participant did not have an event, PFS was censored at the date of last adequate response assessment before the data analysis cut-off date or the start date of new antineoplastic therapy after study drug discontinuation.|up to 18 weeks|Primary endpoint analysis set (PEAS): The PEAS included all participants who received at least one dose of study medication and had measurable disease at baseline as confirmed by a local Investigator.||Months||95% Confidence Interval|Median
696346|NCT01379534|Secondary|Overall Survival (OS)|OS was defined as the time from date of treatment to the date of death from any cause. If a participant was not known to have died at the date of analysis cut-off, the OS was censored at the last date of contact.|up to 18 weeks|Full Analysis Set (FAS): The FAS included all participants who received at least one dose of study medication.||Months||95% Confidence Interval|Median
696347|NCT01379534|Secondary|Duration of Response (DR)|Duration of response was defined for participants with a CR or PR as the time from the date of the first documented response (CR or PR) to the date of the first documented progression or death due to disease. If a participants did not have a progression event, duration of response was censored at the date of the last adequate tumor assessment before the data analysis cut-off date or the antineoplastic therapy start date or the death date.|up to 18 weeks|This outcome measure was not analyzed. The analysis was not required because there were too few responders.|||||
696348|NCT01379534|Secondary|Disease Control Rate (DCR)|DCR was defined as the percentage of participants with a best overall response of CR or PR or stable disease (SD).|Baseline and every 6 weeks until disease progression, up to 18 weeks|Primary endpoint analysis set (PEAS): The PEAS included all participants who received at least one dose of study medication and had measurable disease at baseline as confirmed by a local Investigator.||Percentage of participants|||Number
696349|NCT01379534|Secondary|Overall Response Rate (ORR)|ORR is defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR).|Baseline and every 6 weeks until disease progression, up to 18 weeks|Primary endpoint analysis set (PEAS): The PEAS included all participants who received at least one dose of study medication and had measurable disease at baseline as confirmed by a local Investigator.||Percentage of participants|||Number
696350|NCT01379534|Primary|Progression Free Survival (PFS) Rate|The 18-week PFS was defined as the percentage of participants who did not have a progression event at week 18. Participants who progressed, died, had response assessment of unknown (UNK) or discontinued before 18 weeks of observation without progression were counted as “failure”. Progressive disease was assessed as per investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.|up to 18 weeks|Primary endpoint analysis set (PEAS): The PEAS included all participants who received at least one dose of study medication and had measurable disease at baseline as confirmed by a local Investigator.||Percentage of participants|||Number
696351|NCT01379521|Secondary|Percentage of Participants With a Decrease in the Sum of the of Longest Diameters (SLD) of Target Lesions From Baseline to 30 Months|Percentage of participants with a decrease in the sum of the of longest diameters (SLD) of target lesions from Baseline to 30 months|baseline, 30 months|Full Analysis Set (FAS) comprises all randomized patients.||Percentage of participants|||Number
696352|NCT01379521|Secondary|Incidences of Cumulative New Nodular Recurrence, Portal Vein Invasion and Extra Hepatic Metastases|Incidences of cumulative new nodular recurrence, portal vein invasion and extra hepatic metastases but incidence of portal vein invasion meant those patients without documented vascular invasion at screening/baseline. The study was terminated early due to slow enrollment of 4 years, higher than anticipated screen failure rate due to a higher than anticipated proportion of patients having advanced liver disease and a change in clinical practice the total of 80 patients was not reached with only 59 patients recruited in total. The study was underpowered due to termination therefore data was not collected and the outcome measure was not analyzed.|30 months|Full Analysis Set (FAS) comprises all randomized patients. The trial results are inconclusive as the study was underpowered due to termination therefore data was not collected and the outcome measure was not analyzed.|||||
696353|NCT01379521|Secondary|Overall Survival (OS)|Overall survival was defined as the time from date of randomization to date of death due to any cause. If death had not occurred at the date of the analysis cut-off then OS was censored at the date of the last contact.|6, 12, 18, 24, 30 months|Full Analysis Set (FAS) comprises all randomized patients. The trial results are inconclusive as the study was underpowered||months||90% Confidence Interval|Median
696354|NCT01379521|Secondary|Overall Response Rate (ORR) and Disease Control Rate (DCR) Based on Original RECIST|Overall response rate was defined as the number of patients whose best overall response was either complete response or partial response according to the Complete response: Disappearance of all target lesions or lymph nodes <10 mm in the short axis Partial response: >30% decrease in sum of the longest diameters (SLD) of target lesions Disease control rate was defined as the number of patients with a best overall response of complete response, partial response or stable disease. The study was terminated early due to slow enrollment of 4 years, higher than anticipated screen failure rate due to a higher than anticipated proportion of patients having advanced liver disease and a change in clinical practice the total of 80 patients was not reached with only 59 patients recruited in total. The study was underpowered due to termination therefore data was not collected and the outcome measure was not analyzed.|6, 12 months, end of study|Full Analysis Set (FAS) comprises all randomized patients. The trial results are inconclusive as the study was underpowered due to termination therefore data was not collected and the outcome measure was not analyzed.|||||
696355|NCT01379521|Secondary|Time to Progression Based on Original RECIST|Time to Progression (TTP) defined as the time from the date of randomization to the date of first documented radiological confirmation of disease progression based on original RECIST criteria. Progressive Disease: >20% increase in sum of the longest diameters (SLD) of target lesions with an absolute increase of ≥5 mm; new lesions. The study was terminated early due to slow enrollment of 4 years, higher than anticipated screen failure rate due to a higher than anticipated proportion of patients having advanced liver disease and a change in clinical practice the total of 80 patients was not reached with only 59 patients recruited in total. The study was underpowered due to termination therefore data was not collected and the outcome measure was not analyzed.|6, 12 months, end of study|Full Analysis Set (FAS) comprises all randomized patients. The trial results are inconclusive as the study was underpowered due to termination therefore data was not collected and the outcome measure was not analyzed.|||||
696356|NCT01379521|Secondary|Overall Response Rate (ORR) and Disease Control Rate (DCR) Based on the Modified RECIST|Overall response rate was defined as the number of patients whose best overall response was either complete response or partial response according to the modified RECIST. Complete response: Disappearance of arterial phase enhance-ment in all target lesions. Partial response: >30% decrease in sum of the longest diameters (SLD) of “viable” target lesion (arterial phase enhance-ment)Disease control rate was defined as the number of patients with a best overall response of complete response, partial response or stable disease. The study was terminated early due to slow enrollment of 4 years, higher than anticipated screen failure rate due to a higher than anticipated proportion of patients having advanced liver disease and a change in clinical practice the total of 80 patients was not reached with only 59 patients recruited in total. The study was underpowered due to termination therefore data was not collected and the outcome measure was not analyzed.|6, 12 months, end of study|Full Analysis Set (FAS) comprises all randomized patients. The trial results are inconclusive as the study was underpowered due to termination therefore data was not collected and the outcome measure was not analyzed.|||||
696357|NCT01379521|Primary|Time to Progression (TTP) Based on the Modified RECIST Criteria|Time to Progression (TTP) defined as the time from the date of randomization to the date of first documented radiological confirmation of disease progression based on modified RECIST criteria. Progressive Disease: >20% increase in sum of the longest diameters (SLD) of “viable” target lesion (arterial phase enhancement)|3, 6, 12, 18 and 24 months|Full Analysis Set (FAS) comprises all randomized patients.||months||90% Confidence Interval|Median
696358|NCT01379183|Secondary|Small Intestine and Colon Volume|A Magnetic Resonance (MR) enterography procedure uses magnetic resonance imaging (MRI) technology to obtain detailed images of the small bowel. Small bowel volumes were evaluated with 5 mm thick coronal slices using a fat-suppressed true fast imaging with steady state precession sequence while the participant held his or her breath.|Approximately 60 minutes after beginning ingestion of fluid volume|||mL||Standard Error|Mean
696359|NCT01379183|Secondary|Small Intestine Volume|A Magnetic Resonance (MR) enterography procedure uses magnetic resonance imaging (MRI) technology to obtain detailed images of the small bowel. Small bowel volumes were evaluated with 5 mm thick coronal slices using a fat-suppressed true fast imaging with steady state precession sequence while the participant held his or her breath.|Approximately 60 minutes after beginning ingestion of fluid volume|||mL||Standard Error|Mean
696360|NCT01379183|Secondary|Colonic Volume|A Magnetic Resonance (MR) enterography procedure uses magnetic resonance imaging (MRI) technology to obtain detailed images of the small bowel. Small bowel volumes were evaluated with 5 mm thick coronal slices using a fat-suppressed true fast imaging with steady state precession sequence while the participant held his or her breath.|Approximately 60 minutes after beginning ingestion of fluid volume|||mL||Standard Error|Mean
696361|NCT01379183|Secondary|Ileal Volume|The Ileal is the terminal portion of the small intestine extending from the jejunum to the cecum. A Magnetic Resonance (MR) enterography procedure uses magnetic resonance imaging (MRI) technology to obtain detailed images of the small bowel. Small bowel volumes were evaluated with 5 mm thick coronal slices using a fat-suppressed true fast imaging with steady state precession sequence while the participant held his or her breath.|Approximately 60 minutes after beginning ingestion of fluid volume|||mL||Standard Error|Mean
696362|NCT01379183|Secondary|Jejunal Volume|The jejunum is the section of the small intestine between the duodenum and the ileum. A Magnetic Resonance (MR) enterography procedure uses magnetic resonance imaging (MRI) technology to obtain detailed images of the small bowel. Small bowel volumes were evaluated with 5 mm thick coronal slices using a fat-suppressed true fast imaging with steady state precession sequence while the participant held his or her breath.|Approximately 60 minutes after beginning ingestion of fluid volume|||mL||Standard Error|Mean
696363|NCT01379183|Primary|Gastric Volume|A Magnetic Resonance (MR) enterography procedure uses magnetic resonance imaging (MRI) technology to obtain detailed images of the small bowel. MR images of the abdomen were acquired with a torso phased array coil and a 1.5 tesla magnet MRI. Gastric volumes were assessed with an axial 3D axial gradient echo sequence, which imaged the entire stomach in 13 seconds.|Approximately 60 minutes after beginning ingestion of fluid volume|||mL||Standard Error|Mean
696364|NCT01378988|Primary|Number of Subjects Who Received Rescue Medication for Sedation and Analgesic|Participants who received rescue medication midazolam for sedation and/or fentanyl for analgesic during study drug Infusion|During the treatment (6 to 24 hours)|Full Evaluable Population consisted of all subjects who received study drug for at least 5 hours with adequate pharmacokinetic samples to estimate primary parameters.||participants|||Number
696365|NCT01378988|Primary|Absolute Time That Subject is in UMSS Range 2-4 During Treatment Period|"The level of sedation will be assessed using the University of Michigan Sedation Scale (UMSS).
Score 0 (awake/alert); Score 1 (sleepy/responds appropriately); Score 2 (somnolent/arouses to light stimuli); Score 3 (deep sleep/arouses to deeper physical stimuli); Score 4 (unarousable).
The UMSS scores obtained just prior the loading dose (LD) and 5 and 10 minutes during LD; 0, 5, 10, 15, 30, and 60 minutes and thereafter every 4 hours of the maintenance infusion; within 5 minutes of obtaining each pharmacokinetic sample; within 5 minutes prior and after any midazolam rescue during dexmedetomidine infusion period."|During the treatment (6 to 24 hours)|Full Evaluable Population consisted of all subjects who received study drug for at least 5 hours with adequate PK samples to estimate primary parameters.||Hours||Standard Deviation|Mean
696366|NCT01378988|Primary|Average Total Faces, Legs, Activity, Cry, and Consolability (FLACC) Score|FLACC scale is a 5 category observational measure to assess pediatric pain on face, legs, activity, cry and consolability. Responses in each category are scored between 0 to 2 (0 = normal, relaxed to 2 = upset, rigid), for a maximum total score of 10.|Prior to loading dose and every hour during the maintenance infusion; within 5 minutes after any fentanyl administration during DEX infusion or every 4 hours in case of continuous fentanyl infusion; within 5 minutes prior and after titration of fentanyl|Full Evaluable Population consisted of all subjects who received study drug for at least 5 hours with adequate PK samples to estimate primary parameters.||units on a scale||Standard Deviation|Mean
696498|NCT01377467|Other Pre-specified|Percent Change From Baseline in Cortical Volumetric Bone Mineral Densitiy (Ct.vBMD) at the Distal Tibia|Volumetric BMD (vBMD) was measured via HR-pQCT (Xtreme CT) at the distal tibia and was expressed as mg HA/cm3.|Baseline and month 12|Subgroup of patients (n=24) who participated in the HR-pQCT (Xtreme CT) subprotocol.||Percent change||95% Confidence Interval|Median
696367|NCT01378988|Primary|Weight-Adjusted Volume of Distribution (Vdw)|Weight-Adjusted Volume of distribution of dexmedetomidine after intravenous administration.|30 minutes prior to loading dose (LD); 5 minutes before finishing LD; 0.5, 1, 2 and 4-6 hours during maintenance infusion (MI); 30 minutes prior (within 24 hours of start of MI) and 10 minutes, 0.5, 1, 2, 4 and 10 hours end of MI|Full Evaluable Population consisted of all subjects who received study drug for at least 5 hours with adequate PK samples to estimate primary parameters.||Litre per Kilogram||Standard Deviation|Mean
696368|NCT01378988|Primary|Volume of Distribution (Vd)|Volume of distribution of dexmedetomidine after intravenous administration. Volume of distribution measures how much the drug spreads through the body after the dose.|30 minutes prior to loading dose (LD); 5 minutes before finishing LD; 0.5, 1, 2 and 4-6 hours during maintenance infusion (MI); 30 minutes prior (within 24 hours of start of MI) and 10 minutes, 0.5, 1, 2, 4 and 10 hours end of MI|Full Evaluable Population consisted of all subjects who received study drug for at least 5 hours with adequate PK samples to estimate primary parameters.||Litre||Standard Deviation|Mean
696369|NCT01378988|Primary|Plasma Clearance (CL)|Clearance of dexmedetomidine after intravenous administration. Clearance is the rate at which the drug is removed from the plasma after the dose.|30 minutes prior to loading dose (LD); 5 minutes before finishing LD; 0.5, 1, 2 and 4-6 hours during maintenance infusion (MI); 30 minutes prior (within 24 hours of start of MI) and 10 minutes, 0.5, 1, 2, 4 and 10 hours end of MI|Full Evaluable Population consisted of all subjects who received study drug for at least 5 hours with adequate PK samples to estimate primary parameters.||Litre per Hour||Standard Deviation|Mean
696370|NCT01378988|Primary|Weight-Adjusted Plasma Clearance (CLw)|Weight-Adjusted Plasma Clearance of dexmedetomidine after intravenous administration.|30 minutes prior to loading dose (LD); 5 minutes before finishing LD; 0.5, 1, 2 and 4-6 hours during maintenance infusion (MI); 30 minutes prior (within 24 hours of start of MI) and 10 minutes, 0.5, 1, 2, 4 and 10 hours end of MI|Full Evaluable Population consisted of all subjects who received study drug for at least 5 hours with adequate PK samples to estimate primary parameters.||Litre per Hours per Kilogram||Standard Deviation|Mean
696371|NCT01378988|Primary|Time to Reach Maximum Plasma Concentration (Tmax)|Observed time to reach maximum plasma concentration of dexmedetomidine, expressed in hours|30 minutes prior to loading dose (LD); 5 minutes before finishing LD; 0.5, 1, 2 and 4-6 hours during maintenance infusion (MI); 30 minutes prior (within 24 hours of start of MI) and 10 minutes, 0.5, 1, 2, 4 and 10 hours end of MI|Full Evaluable Population consisted of all subjects who received study drug for at least 5 hours with adequate PK samples to estimate primary parameters.||Hours||Standard Deviation|Mean
696372|NCT01378988|Primary|Terminal Elimination Half-life (t1/2)|Terminal elimination half-life of dexmedetomidine. Half-life is the time required for plasma concentration of the drug to decrease by 50%.|30 minutes prior to loading dose (LD); 5 minutes before finishing LD; 0.5, 1, 2 and 4-6 hours during maintenance infusion (MI); 30 minutes prior (within 24 hours of start of MI) and 10 minutes, 0.5, 1, 2, 4 and 10 hours end of MI|Full Evaluable Population consisted of all subjects who received study drug for at least 5 hours with adequate PK samples to estimate primary parameters.||Hours||Standard Deviation|Mean
696373|NCT01378988|Primary|Steady State Concentration (Css)|Concentration of dexmedetomidine at steady state in plasma|30 minutes prior to loading dose (LD); 5 minutes before finishing LD; 0.5, 1, 2 and 4-6 hours during maintenance infusion (MI); 30 minutes prior (within 24 hours of start of MI) and 10 minutes, 0.5, 1, 2, 4 and 10 hours end of MI|Full Evaluable Population consisted of all subjects who received study drug for at least 5 hours with adequate PK samples to estimate primary parameters.||picogram per millilitre||Standard Deviation|Mean
696374|NCT01378988|Primary|Observed Peak Plasma Concentration (Cmax)|Maximum observed concentration of dexmedetomidine in plasma|30 minutes prior to loading dose (LD); 5 minutes before finishing LD; 0.5, 1, 2 and 4-6 hours during maintenance infusion (MI); 30 minutes prior (within 24 hours of start of MI) and 10 minutes, 0.5, 1, 2, 4 and 10 hours end of MI|Full Evaluable Population consisted of all subjects who received study drug for at least 5 hours with adequate PK samples to estimate primary parameters.||picogram per millilitre||Standard Deviation|Mean
696375|NCT01378988|Primary|Area Under the Plasma Concentration-time Curve (AUC0-∞)|Area under the plasma concentration-time curve of dexmedetomidine at 0 to Infinity hours|30 minutes prior to loading dose (LD); 5 minutes before finishing LD; 0.5, 1, 2 and 4-6 hours during maintenance infusion (MI); 30 minutes prior (within 24 hours of start of MI) and 10 minutes, 0.5, 1, 2, 4 and 10 hours end of MI|Full Evaluable Population consisted of all subjects who received study drug for at least 5 hours with adequate PK samples to estimate primary parameters.||picogram*hour per millilitre||Standard Deviation|Mean
696376|NCT01378975|Secondary|Percentage of Participants With Adverse Events (AE)|An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.|From signing of informed consent form up to 28 days after the last dose of study drug (approximately up to 4 years)|The safety population included all participants who received at least one dose of study medication.||percentage of participants|||Number
696377|NCT01378975|Secondary|Best Overall Response Rate (BORR) Within the Brain and Outside Brain (Not Necessarily Follows the RECIST Criteria - as Assessed by Investigator)|Percentage of participants who were responders (with best overall response (BOR) documented as confirmed complete response [CR] or partial response [PR]) were reported.|Baseline up to the disease progression or death from any cause (approximately 4 years)|The ITT population included all participants who were enrolled in the study.||percentage of participants||95% Confidence Interval|Number
696394|NCT01378962|Secondary|Percentage of Participants With a Response by Best Overall Response|Tumor response was assessed according to RECIST v1.1. Complete response (CR): complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes must decrease to normal (short axis less than 10 mm), with no new lesions. Partial response (PR): greater than or equal to (>=) 30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease, and no new lesions. PD: >=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Stable disease (SD): not qualifying for CR, PR, or PD.|Baseline up to disease progression or end of study (up to 12 Months)|ITT population.||percentage of participants|||Number
696378|NCT01378975|Secondary|Best Overall Response Rate (BORR) Within the Brain and Outside Brain (Assessed by Investigator)|Percentage of participants who were responders with BOR documented as confirmed CR or PR, stable disease (SD), progressive disease (PD). CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.|Baseline up to the disease progression or death from any cause (approximately 4 years)|The ITT population included all participants who were enrolled in the study. Here, ‘n’ indicates the number participants who were evaluable for within brain assessment and who had measurable disease outside brain at baseline for outside brain assessment.||percentage of participants|||Number
696379|NCT01378975|Secondary|Overall Survival|Overall survival was defined as time between enrollment on Day 1 and date of death, irrespective of the cause of death. Participants for whom no death was captured on the clinical database were censored at the latest date they were known to be alive prior to or on the cutoff date.|Baseline up to the disease progression or death from any cause (approximately 4 years)|The ITT population included all participants who were enrolled in the study.||months||Full Range|Median
696380|NCT01378975|Secondary|Time to Development of New Brain Metastases in Responders|Time to development of new lesions within the brain was defined as the interval between the date of first treatment and the earliest date of documentation of new brain lesions. Participants who were known to be free of new lesions were censored on the date of last tumor assessment.|Date of first treatment and the earliest date of documentation of new brain lesions (approximately up to 4 years)|The ITT population included all participants who were enrolled in the study. Here, number of participants analyzed is the participants who were responders.||months||Full Range|Median
696381|NCT01378975|Secondary|Progression-Free Survival (PFS) Based on Tumor Assessment Within Brain Only (Assessed by Investigator )|Progression-free survival was defined as the time between enrollment on Day 1 and the date of first radiographically documented progressive disease (within brain), clinical progressive disease, as assessed by the investigator or death whichever occurred first.|Baseline up to the disease progression or death from any cause (approximately 4 years)|The ITT population included all participants who were enrolled in the study.||months||Full Range|Median
696382|NCT01378975|Secondary|Progression-Free Survival (PFS) Based on Overall Tumor Response (Assessed by Investigator)|Progression-free survival was defined as the time between enrollment on Day 1 and the date of first radiographically documented progressive disease (within or outside the brain), clinical progressive disease, as assessed by the investigator or death whichever occurred first.|Baseline up to the disease progression or death from any cause (approximately 4 years)|The ITT population included all participants who were enrolled in the study.||months||Full Range|Median
696383|NCT01378975|Secondary|Duration of Response (DOR) (Assessed by Investigator and IRC)|Duration of response was defined as the time interval between the date of the earliest qualifying response and the earliest date of PD or death from any cause. For participants who were alive without progression following the qualifying response, DOR were censored on the date of last available tumor assessment on or before the data cutoff date.|Date of the earliest qualifying response until the earliest date of PD or death from any cause (approximately up to 4 years)|The ITT population included all participants who were enrolled in the study. Here, 'n' indicates number of participants who were responders within brain or outside brain assessed by investigator or IRC.||months||Full Range|Median
696384|NCT01378975|Secondary|Best Overall Response Rate Outside the Brain (Assessed by IRC)|BORR outside of brain assessed by IRC is defined as percentage of participants who were responders (with BOR documented as confirmed CR or PR). According to RECIST v1.1 criteria modified for brain metastases, CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm, PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|Baseline up to the disease progression or death from any cause (approximately 4 years)|The ITT population included all participants who were enrolled in the study. Here, number participants analyzed is the total number of participants who had measurable disease outside brain at baseline.||percentage of participants||95% Confidence Interval|Number
696385|NCT01378975|Secondary|Best Overall Response Rate (BORR) in the Brain of Participants With Previously Treated Brain Metastases as Assessed by the IRC Using RECIST v1.1|BORR within brain assessed by IRC is defined as percentage of participants who were responders (with BOR documented as confirmed CR or PR). According to RECIST v1.1 criteria modified for brain metastases, CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm, PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|Baseline up to the disease progression or death from any cause (approximately 4 years)|The ITT population included all participants who were enrolled in the study.||percentage of participants||95% Confidence Interval|Number
696386|NCT01378975|Secondary|Best Overall Response Rate (BORR) in the Brain of Participants With Previously Treated or Untreated Brain Metastases as Assessed by the IRC Using RECIST v1.1|Percentage of participants who were responders with BOR documented as confirmed CR or PR, stable disease (SD), progressive disease (PD). CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.|Baseline up to the disease progression or death from any cause (approximately 4 years)|The ITT population included all participants who were enrolled in the study.||percentage of participants|||Number
702058|NCT00075504|Secondary|Progression Free Survival|PFS will be measured from the time of the patient’s initial best response (PR or CR) until documented progression.|Up to 2 years|||months||95% Confidence Interval|Median
696387|NCT01378975|Primary|Best Overall Response Rate (BORR) Within Brain of Previously Untreated Participants (Assessed by Independent Review Committee [IRC] Using Modified Response Evaluation Criteria in Solid Tumors [RECIST])|BORR assessed by IRC is defined as percentage of participants who were responders [with best overall response (BOR) documented as confirmed complete response (CR) or partial response (PR)]. The RECIST v1.1 criteria modified for independent review of body and brain lesions was based on current radiology practices. The modifications to RECIST v1.1 included allowing target lesions in the brain to be >=5 mm by contrast-enhanced magnetic resonance imaging scan (in traditional RECIST v1.1 this is >=10 mm), allowing up to 5 target lesions in the brain (in traditional RECIST v1.1 only 2 target lesions), and examining the lesions within the brain and outside the brain separately for analytical purposes. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeters (mm), PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|Baseline up to the disease progression or death from any cause (approximately 4 years)|The intent to treat (ITT) population included all participants who were enrolled in the study.||percentage of participants||95% Confidence Interval|Number
696388|NCT01378962|Secondary|Percentage of Participants With Epidermal Growth Factor Receptor (EGFR) Mutation by Mutation Type|EGFR is a gene in the tumor tissues and mutations in this gene have been linked to a variety of tumors. Presence or absence of EGFR mutation was determined in liquid biopsies by reverse transcriptase-polymerase chain reaction (RT-PCR /Cobas).|Baseline, At progression of disease (up to 12 Months)|Analysis population included all participants enrolled in the study who received at least 1 dose of treatment and who had samples for EGFR mutation. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.||percentage of participants|||Number
696389|NCT01378962|Secondary|Percentage of Participants With Primary and Secondary Resistance|Primary resistance: participants did not reach SD or PR or CR before going to PD. Secondary resistance: participants experienced PD after having reached SD or PR or CR at least once. CR: complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes must decrease to normal (short axis less than 10 mm), with no new lesions. PR: >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease, and no new lesions. PD: >=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.|Baseline up to disease progression (up to 12 Months)|Analysis population included all participants enrolled in the study who received at least 1 dose of treatment and who had a documented PD response during the study period.||percentage of participants|||Number
696390|NCT01378962|Secondary|Percentage of Participants Achieving CR, PR, or SD as Best Overall Response|The Disease Control Rate was defined as the percentage of participants who had CR or PR or SD as Best Overall Response achieved within the time between the first drug administration and documented disease progression or end of study. According to RECIST v1.1, CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than 10 mm), with no new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease, and no new lesions. SD was defined as not qualifying for CR, PR, or PD.|Baseline up to disease progression or end of study (up to 12 Months)|ITT population.||percentage of participants||95% Confidence Interval|Number
696391|NCT01378962|Primary|Probability of Being Progression Free 12 Months After Baseline|According to RECIST v1.1, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.|12 months|ITT population.||probability of being progression-free||Standard Error|Mean
696392|NCT01378962|Primary|Progression-Free Survival (PFS)|PFS was defined as the time from baseline to the date of first occurrence of disease progression or death. According to RECIST v1.1, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. PFS was assessed using Kaplan-Meier method.|Up to 1 year after enrollment of the last participant (maximum up to 27 months)|ITT population.||months||90% Confidence Interval|Median
696393|NCT01378962|Secondary|Percentage of Participants With Objective Response|Objective response was defined as the percentage of participants with CR or PR as best overall response by RECIST v1.1. To be assigned the status of PR or CR, changes in tumor measurements were to be confirmed by repeated assessments no less than 4 weeks after the criteria for response were first met. CR was defined as complete disappearance of all target lesions and non-target disease, with exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than 10 mm), with no new lesions. PR was defined as >=30% decrease under baseline of sum of diameters of all target lesions. The short axis was used in sum for target nodes, while longest diameter was used in sum for all other target lesions. No unequivocal progression of non-target disease, and no new lesions. Participants with no tumor assessment after start of study treatment were considered as non-responders. The percentage of participants with response is presented.|Baseline up to disease progression or end of study (up to 12 Months)|ITT population.||percentage of participants||95% Confidence Interval|Number
696395|NCT01378962|Secondary|Overall Survival (OS)|OS was defined as the time from randomization to the date of death due to any cause. OS was assessed using Kaplan-Meier method.|Every 8 weeks during treatment, after discontinuation participants were followed for up to 1 year after enrollment of the last participant (maximum up to 27 months)|ITT population.||months||Standard Error|Mean
710631|NCT00165984|Primary|To Evaluate the Incidence of the Pre-proendothelin SNP at Nucleotide 5665||7 years|165 enrolled patients were analyzed for this polymorphism||participants|||Number
696397|NCT01378962|Primary|Percentage of Participants With Disease Progression or Death at 12 Months After Baseline|According to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), progressive disease (PD) was defined as at least a 20 percent (%) increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.|12 months|Intent to treat (ITT) population included all participants enrolled in the study who received at least 1 dose of treatment.||percentage of participants|||Number
696398|NCT01378520|Secondary|Change in Level of B-endorphin Immunoreactivity|Change in serum levels of beta-endorphin immunoreactivity measured in pmol/L|At the end of resistance load breathing (4.5 hours after receiving the test article)|||pmol/L||Standard Deviation|Mean
696399|NCT01378520|Primary|Intensity of Breathlessness|"The average of all ratings for the intensity of breathlessness at equivalent times for each subject during Resistive Load Breathing (RLB). For example, if 1 subject provided 6 ratings during 6 minutes of RLB with Ketoconazole and 10 ratings during 10 minutes of RLB with inert powder, then ratings for intensity through 6 minutes were used for analysis for that patient. This approach was used for all subjects to yield a total of 252 ratings for Ketoconazole and for inert powder.
Subject rating of intensity of breathlessness was obtained at 1 minute intervals during RLB on a 100 mm Visual Analog Scale anchored at the bottom by No Intensity and at the top by Greatest Intensity."|At 1 minute intervals during Resistive Load Breathing at Period 1 (Day 3 or 4) and Period 2 (Day 5, 6 or 7)|||units on a scale||Standard Deviation|Mean
696400|NCT01378520|Primary|Unpleasantness of Breathlessness|"The average of all ratings for the unpleasantness of breathlessness at equivalent times for each subject during Resistive Load Breathing (RLB). For example, if 1 subject provided 6 ratings during 6 minutes of RLB with Ketoconazole and 10 ratings during 10 minutes of RLB with inert powder, then ratings for unpleasantness through 6 minutes were used for analysis for that patient. This approach was used for all subjects to yield a total of 252 ratings for Ketoconazole and for inert powder.
Subject rating of intensity of unpleasantness was obtained during RLB on a 100 mm Visual Analog Scale anchored at the bottom by No Unpleasantness and at the top by Greatest Unpleasantness."|At 1 minute intervals during Resistive Load Breathing at Period 1 (Day 3 or 4) and Period 2 (Day 5, 6 or 7)|||units on a scale||Standard Deviation|Mean
696401|NCT01378429|Secondary|Change From Baseline in Averaged Daily Subject-reported AM and PM Reflective TNSS Averaged Over the 6 Weeks of Double-blind Treatment|TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1 = mild 2 = moderate 3 = severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement|weeks 0-6|Intent-to-treat (ITT) Population: All randomized subjects who received at least 1 dose of double blind study medication.||units on a scale||Standard Deviation|Mean
696402|NCT01378429|Secondary|Percentage of Devices With Actuation Consistency, Where Actuation Consistency is Defined as a Dose Indicator Count Within ± 20% of the Subject Self-report of Study Medication Administration||weeks 0-6|Intent-to-treat (ITT) Population: All randomized subjects who received at least 1 dose of double blind study medication.||percentage of devices|Participants||Number
696403|NCT01378429|Secondary|Number of Devices With Actuation Consistency, Where Actuation Consistency is Defined as a Dose Indicator Count Within ± 20% of the Subject Self-report of Study Medication Administration||weeks 0-6|Intent-to-treat (ITT) Population: All randomized subjects who received at least 1 dose of double blind study medication.||Devices|Participants||Number
696404|NCT01378429|Secondary|Ratio (Percentage) of the Number of Correct Advances of the Dose Indicator to the Number of Expected Advances Based on Subject Self-report of Study Medication Administration Plus Extra Non-nasal Actuations||weeks 0-6|Intent-to-treat (ITT) Population: All randomized subjects who received at least 1 dose of double blind study medication.||percentage of number of correct advances||Standard Deviation|Mean
696405|NCT01378429|Secondary|Apparent Volume of Distribution (Vz/F)|Vz/F Liters (L) is the apparent volume of distribution|Week 6|PK Population: Subjects in the ITT population who completed the study on treatment medication and had assayed serum concentrations of ciclesonide and/or des ciclesonide. Descriptive statistics were presented for serum drug/metabolite concentrations and evaluable pharmacokinetic parameters.||L||Standard Deviation|Mean
696406|NCT01378429|Secondary|Apparent Clearance of the Drug (CL/F)|CL/F liter per hour (L/hour) is the apparent clearance of the drug|Week 6|PK Population: Subjects in the ITT population who completed the study on treatment medication and had assayed serum concentrations of ciclesonide and/or des ciclesonide. Descriptive statistics were presented for serum drug/metabolite concentrations and evaluable pharmacokinetic parameters.||L/hour||Standard Deviation|Mean
696407|NCT01378429|Secondary|Terminal Half Life (t1/2)|Terminal half-life (t1/2) (hour)|Weeks 6|PK Population: Subjects in the ITT population who completed the study on treatment medication and had assayed serum concentrations of ciclesonide and/or des ciclesonide. Descriptive statistics were presented for serum drug/metabolite concentrations and evaluable pharmacokinetic parameters.||Hour||Standard Deviation|Mean
696408|NCT01378429|Secondary|Time to the Occurrence of Cmax|tmax (hour) (PK Population)|Week 6|PK Population: Subjects in the ITT population who completed the study on treatment medication and had assayed serum concentrations of ciclesonide and/or des ciclesonide. Descriptive statistics were presented for serum drug/metabolite concentrations and evaluable pharmacokinetic parameters.||Hour||Standard Deviation|Mean
696409|NCT01378429|Secondary|Maximum Observed Concentration|Cmax (ng/mL) (PK Population)|Week 6|PK Population: Subjects in the ITT population who completed the study on treatment medication and had assayed serum concentrations of ciclesonide and/or des ciclesonide. Descriptive statistics were presented for serum drug/metabolite concentrations and evaluable pharmacokinetic parameters.||ng/mL||Standard Deviation|Mean
696410|NCT01378429|Secondary|AUC(0-24h)|Area under the concentration-time curve from time 0 to 24 hours. Collected at 0, 30 min, 60 min, 90 min, 2 hours (h), 4 h, 8 h, 12 h, 16 h, and 24h after dosing.|Week 6|PK Population: Subjects in the ITT population who completed the study on treatment medication and had assayed serum concentrations of ciclesonide and/or des ciclesonide. Descriptive statistics were presented for serum drug/metabolite concentrations and evaluable pharmacokinetic parameters.||ng*hr/mL||Standard Deviation|Mean
696417|NCT01378429|Primary|The Change in Serum Cortisol Area Under the Curve (AUC) From Time 0 to 24 Hours (0-24), Calculated Using a Trapezoidal Rule, From Baseline to the End of the 6 Week Treatment Period|Area under the concentration-time curve from time 0 to 24 hours [AUC(0-24h)]. Timepoints at which data were collected: 0, 2, 4, 8, 12, 16, and 24 at week 0 and 6.|Week 0 and 6|The Per Protocol (PP) population consisted of all ITT subjects who had sufficient blood sample collection at Visit 4/BL and Visit 7/End of Week 6 for serum cortisol measurements, completed the study on treatment medication and had no important protocol deviations (IPDs).||mcg•hour/dL||Standard Error|Least Squares Mean
696418|NCT01378416|Primary|AUC (0-∞) - Area Under the Plasma Concentration-time Curve Extrapolated to Infinity|3-hour IV infusion, every 8 hours for three consecutive days. AUC (0-∞) was measured post first dose (Day 1), fourth dose (Day 2), and seventh dose (Day 3).|Day 1, Day 2, day 3|||ng∙hr/mL||Standard Deviation|Mean
696419|NCT01378416|Primary|Tmax (Time at Which Cmax First Observed)|3-hour IV infusion, every 8 hours for three consecutive days. Tmax was measured post first dose (Day 1), fourth dose (Day 2), and seventh dose (Day 3).|Day 1, Day 2, Day 3|||hours||Standard Deviation|Mean
696420|NCT01378416|Primary|Cmax (Maximum Plasma Concentration)|3-hour IV infusion, every 8 hours for three consecutive days. Cmax was measured post first dose (Day 1), fourth dose (Day 2), and seventh dose (Day 3).|Day 1, Day 2, Day 3|||ng/mL||Standard Deviation|Mean
696421|NCT01378416|Primary|Average Total Body Clearance (Calculated From Rate and Concentration)|3-hour IV infusion, every 8 hours for three consecutive days. Average Total Body Clearance was measured post first dose (Day 1), fourth dose (Day 2), and seventh dose (Day 3).|Day 1, Day 2, Day 3|||L/hr/m^2|||Number
696422|NCT01378416|Secondary|Safety: The Most Frequently Reported Adverse Events (Regardless of Causality)|Summary of All Adverse Events (AEs) by Maximum Grade Occurring in >= 10% Patients|6 weeks|||Participants|||Number
696423|NCT01378325|Primary|Number of Physician Interventions Needed to Maintain Maternal Blood Pressure After Spinal Anesthesia Within 20% of Baseline and to Treat Bradycardia During Cesarean Delivery.|"Physician interventions are triggered by hemodynamic changes more than 20% of baseline. The intervention can be one or more of the following:
stopping the phenylephrine infusion
changing the rate of phenylephrine infusion
rescue intravenous bolus of phenylephrine (100 µg) for hypotension
rescue intravenous bolus of atropine (0.4 mg) for bradycardia"|Patients will be followed up throughout the Cesarean delivery (average of 1.5 hours).|||number of interventions||Full Range|Median
696424|NCT01378221|Primary|Peri- and Postoperative Time Course of Circulating 1,25-dihydroxyvitamin D in the First Postoperative Month in Cardiac Surgery Patients||change from baseline within 1 month after cardiac surgery|||percentage||Standard Error|Mean
696425|NCT01378195|Secondary|Perceived Quality of Life|"The Perceived Quality of Life (PQoL instrument) measures quality of life by the evaluation of major categories of fundamental life needs. This measure was developed using a normative sample of older individuals, and has been used in a number of studies investigating the effects of chronic disorders on the perceived quality of life. The scale contains items describing level of satisfaction with needs and resources in various categories. The scale refers to the caregiver. Minimum (worst value) = 0. Maximum score (best value=10. Higher values represent a better outcome."|3 months|||units on a scale||Standard Deviation|Mean
696426|NCT01378195|Secondary|Revised Memory and Behavior Problems Checklist|"This scale measures the type/number of dementia patients disturbing behaviors, and how much they bother caregivers with 24 items describing possible troublesome behaviors that the patient might evidence in the past month. Caregivers are first asked whether the dementia patient had displayed any of these in the time period, and secondly to rate on a 5-point scale (0=not at all; 4= extremely) how much this bothered or upset them. A conditional bother score is calculated which is the upset or bother ratings for only the problematic behavior that occurred. The scale refers to the caregiver. Minimum score (best value)=0. Maximum score (worst value)=4. Higher values represent a worse outcome."|3 months|||units on a scale||Standard Deviation|Mean
696427|NCT01378195|Primary|Perceived Stress Scale|"The Perceived Stress Scale measures the overall level of stress. This instrument contains 10 items accessing overall appraisals of stress in the past month. The scale refers to the caregiver. Minimum score (best value)=0. Maximum score (worst value)=40. Higher values represent a worse outcome."|3 months|||units on a scale||Standard Deviation|Mean
696428|NCT01378117|Secondary|Hospital Mortality|Hospital mortality. Mortality is defined as death occurring during admission|during hospitalization, average 5 days||||||
696429|NCT01378117|Secondary|Acute Renal Failure|Acute renal failure is defined as a clinical diagnosis of acute renal failure with documented new-onset abnormal renal function (serum creatinine > 2.2 mg/dL or an increment > 0.5 mg/dL from baseline).|during hospitalization, average 5 days||||||
696430|NCT01378117|Secondary|Composite Cardiac Complications|Cardiac complications are defined as myocardial infarction, cardiac arrhythmia requiring medical treatment, congestive heart failure, or cardiac arrest.|during hospitalization, average 5 days||||||
696431|NCT01378117|Secondary|ICU Need|Need for ICU care (transfer to ICU)|during hospitalization, average 5 days||||||
696432|NCT01378117|Secondary|Total Daily Dose of Insulin||during hospitalization, average 5 days||||||
696433|NCT01378117|Secondary|Hyperglycemia|Number of episodes of hyperglycemia (BG > 300 mg/dl) after the first day of treatment.|during hospitalization, average 5 days||||||
696434|NCT01378117|Secondary|Severe Hypoglycemia|severe hypoglycemic events (<40 mg/dl).|during hospitalization, average 5 days||||||
696435|NCT01378117|Secondary|Hypoglycemia|Number of hypoglycemic events (<70 mg/dl)|during hospitalization, average 5 days||||||
696436|NCT01378117|Primary|Glucose Levels|The primary outcome of the study is to determine differences in glycemic control as measured by mean daily BG concentration between sitagliptin once daily and basal bolus therapy with glargine once daily plus supplemental lispro insulin in hospitalized patients with T2DM.|during hospitalization, average 5 days|||mg/dl||Standard Deviation|Mean
696437|NCT01378104|Secondary|IL28B Polymorphism Effect on SVR|We additionally investigate the IL28B polymorphism and this result can effect on the SVR depending on dosage of peginterferon alfa-2a.|post treatment 24 weeks|The patients who agreed to check the genotype were analysed.||percentage of SVR|||Number
696438|NCT01378104|Primary|Sustained Virologic Response Depending on the Dosage of Peginterferon Alfa 2a|We investigate whether the SVR between 100% and 80% group of peginterferon alfa 2a is not different.|post treatment 24 weeks|We present the result of intention-to-treat analysis.||participants who achieved SVR|||Number
696439|NCT01378065|Secondary|Bowel Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Colorectal-Anal Distress Inventory 8 (CRADI-8) Questionnaire at the12 Month Visit|Colorectal-anal Distress Inventory is measured by the CRADI-8 at 12 months. The range of responses is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit. Scores are calculated by multiplying the mean value of all questions answered by 25. The range of responses is: 0-100 with 0 (least distress) to 100 (most distress).|Baseline and 12 months|All subjects||units on a scale||Standard Deviation|Mean
696440|NCT01378065|Secondary|Bowel Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Colorectal-Anal Distress Inventory 8 (CRADI-8) Questionnaire at the 6 Month Visit|Colorectal-anal Distress Inventory is measured by the CRADI-8 at 6 months. The range of responses is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit. Scores are calculated by multiplying the mean value of all questions answered by 25. The range of responses is: 0-100 with 0 (least distress) to 100 (most distress).|Baseline and 6 months|All subjects||units on a scale||Standard Deviation|Mean
696441|NCT01378065|Secondary|Bowel Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Colorectal-Anal Distress Inventory 8 (CRADI-8) Questionnaire at the 3 Month Visit|Colorectal-anal Distress Inventory is measured by the CRADI-8 at 3 months. The range of responses is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit. Scores are calculated by multiplying the mean value of all questions answered by 25. The range of responses is: 0-100 with 0 (least distress) to 100 (most distress).|Baseline and 3 months|All subjects||units on a scale||Standard Deviation|Mean
696442|NCT01378065|Secondary|Bowel Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Colorectal-Anal Distress Inventory 8 (CRADI-8) Questionnaire at the 6 Week Visit|Colorectal-anal Distress Inventory is measured by the CRADI-8 at 6 weeks. The range of responses is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit. Scores are calculated by multiplying the mean value of all questions answered by 25. The range of responses is: 0-100 with 0 (least distress) to 100 (most distress).|Baseline and 6 weeks|All subjects||units on a scale||Standard Deviation|Mean
696443|NCT01378065|Secondary|Sexual Function After Vaginal Reconstruction With Restorelle Direct Fix Measured by Participant Sexual Function Questionnaire-12 (PISQ-12) at 12 Months|Sexual function in women with pelvic organ prolapse is measured by the PISQ-12 at12 months. The scores range from 0-48 with lower scores indicating better sexual function. Scores are calculated by totalling the scores for each question with (4) always, (3) usually, (2) sometimes, (1) seldom, and (0) never. Reverse scoring is used for items 1, 2, 3 and 4. The short form questionnaire can be used with up to two missing responses. To handle missing values, the sum is calculated by multiplying the number of items by the mean of the answered items.|Baseline and 12 months|The 25 subjects who completed the PISQ-12 at the twelve month follow up visit.||units on a scale||Standard Deviation|Mean
696444|NCT01378065|Secondary|Sexual Function After Vaginal Reconstruction With Restorelle Direct Fix Measured by Participant Sexual Function Questionnaire-12 (PISQ-12) at 6 Months|Sexual function in women with pelvic organ prolapse is measured by the PISQ-12 at 6 months. The scores range from 0-48 with lower scores indicating better sexual function. Scores are calculated by totalling the scores for each question with (4) always, (3) usually, (2) sometimes, (1) seldom, and (0) never. Reverse scoring is used for items 1, 2, 3 and 4. The short form questionnaire can be used with up to two missing responses. To handle missing values, the sum is calculated by multiplying the number of items by the mean of the answered items.|Baseline and 6 months|The 26 subjects who completed the PISQ-12 at the six month follow up visit.||units on a scale||Standard Deviation|Mean
696445|NCT01378065|Secondary|Sexual Function After Vaginal Reconstruction With Restorelle Direct Fix Measured by Participant Sexual Function Questionnaire-12 (PISQ-12) at 3 Months|Sexual function in women with pelvic organ prolapse is measured by the PISQ-12 at 3 months. The scores range from 0-48 with lower scores indicating better sexual function. Scores are calculated by totalling the scores for each question with (4) always, (3) usually, (2) sometimes, (1) seldom, and (0) never. Reverse scoring is used for items 1, 2, 3 and 4. The short form questionnaire can be used with up to two missing responses. To handle missing values, the sum is calculated by multiplying the number of items by the mean of the answered items.|Baseline and 3 months|The 25 subjects who completed the PISQ-12 at the three month follow up visit.||units on a scale||Standard Deviation|Mean
696446|NCT01378065|Secondary|Sexual Function After Vaginal Reconstruction With Restorelle Direct Fix Measured by Participant Sexual Function Questionnaire-12 (PISQ-12) at 6 Weeks|Sexual function in women with pelvic organ prolapse is measured by the PISQ-12 at 6 weeks. The scores range from 0-48 with lower scores indicating better sexual function. Scores are calculated by totalling the scores for each question with (4) always, (3) usually, (2) sometimes, (1) seldom, and (0) never. Reverse scoring is used for items 1, 2, 3 and 4. The short form questionnaire can be used with up to two missing responses. To handle missing values, the sum is calculated by multiplying the number of items by the mean of the answered items.|Baseline and 6 weeks|The 28 subjects who completed the PISQ-12 at the six week follow up visit.||units on a scale||Standard Deviation|Mean
696447|NCT01378065|Secondary|Bladder Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Urinary Distress Inventory-6 (UDI-6) Questionnaire at 12 Months|Bladder function is measured by UDI-6 Questionnaire at 12 months. The UDI-6 measures bladder function. The range of responses is: 1-4 with (1) not at all, (2) somewhat, (3) moderately, and (4 quite a bit). To allow for missing responses, the average score of items responded to, rather than the total, is taken. The average, which ranges from 1 to 4, is multiplied by 25 to put scores on a scale of 0 to 100. Higher scores indicate worse symptoms.|Baseline and 12 months|All subjects.||units on a scale||Standard Deviation|Mean
696448|NCT01378065|Secondary|Bladder Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Urinary Distress Inventory-6 (UDI-6) Questionnaire at 6 Months|Bladder function is measured by UDI-6 Questionnaire at 6 months. The UDI-6 measures bladder function. The range of responses is: 1-4 with (1) not at all, (2) somewhat, (3) moderately, and (4 quite a bit). To allow for missing responses, the average score of items responded to, rather than the total, is taken. The average, which ranges from 1 to 4, is multiplied by 25 to put scores on a scale of 0 to 100. Higher scores indicate worse symptoms.|Baseline and 6 months|All subjects.||units on a scale||Standard Deviation|Mean
700135|NCT00036738|Primary|Relapse Free Survival|Number of patients with relapsed disease within 1 Year post-transplant. Relapse is defined as the detection of > 5% blasts after a documented complete remission.|Assessed up to 1 year|||Participants|||Count of Participants
696449|NCT01378065|Secondary|Bladder Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Urinary Distress Inventory-6 (UDI-6) Questionnaire at 3 Months|Bladder function is measured by UDI-6 Questionnaire at 3 months. The UDI-6 measures bladder function. The range of responses is: 1-4 with (1) not at all, (2) somewhat, (3) moderately, and (4 quite a bit). To allow for missing responses, the average score of items responded to, rather than the total, is taken. The average, which ranges from 1 to 4, is multiplied by 25 to put scores on a scale of 0 to 100. Higher scores indicate worse symptoms.|Baseline and 3 months|All subjects.||units on a scale||Standard Deviation|Mean
696450|NCT01378065|Secondary|Bladder Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Urinary Distress Inventory-6 (UDI-6) Questionnaire at 6 Weeks|Bladder function is measured by UDI-6 Questionnaire at 6 weeks. The UDI-6 measures bladder function. The range of responses is: 1-4 with (1) not at all, (2) somewhat, (3) moderately, and (4 quite a bit). To allow for missing responses, the average score of items responded to, rather than the total, is taken. The average, which ranges from 1 to 4, is multiplied by 25 to put scores on a scale of 0 to 100. Higher scores indicate worse symptoms.|Baseline and 6 weeks|All subjects.||units on a scale||Standard Deviation|Mean
696451|NCT01378065|Secondary|Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 12 Months.|"The PGI-I Index consists on one question and was collected at 12 months. The question is Check the box that best describes how your condition is now, compared with how it was before you had the operation. There are seven possible responses including very much better, much better, a little better, no change, a little worse, much worse and very much worse and the subject chooses one response."|12 months|All subjects||participants|||Number
696452|NCT01378065|Secondary|Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 6 Months.|"The PGI-I Index consists on one question and was collected at 6 months. The question is Check the box that best describes how your condition is now, compared with how it was before you had the operation. There are seven possible responses including very much better, much better, a little better, no change, a little worse, much worse and very much worse and the subject chooses one response."|6 months|The 29 subjects who completed the PGI-I at the six month follow up visit.||participants|||Number
696453|NCT01378065|Secondary|Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 3 Months.|"The PGI-I Index consists on one question and was collected at 3 months. The question is Check the box that best describes how your condition is now, compared with how it was before you had the operation. There are seven possible responses including very much better, much better, a little better, no change, a little worse, much worse and very much worse and the subject chooses one response."|3 months|The 29 subjects who completed the PGI-I at the three month follow up visit.||participants|||Number
696454|NCT01378065|Secondary|Patient Global Impression of Improvement (PGI-I) Questionnaire Since Treatment at 6 Weeks.|"The PGI-I Index consists on one question and was collected at 6 weeks. The question is Check the box that best describes how your condition is now, compared with how it was before you had the operation. There are seven possible responses including very much better, much better, a little better, no change, a little worse, much worse and very much worse and the subject chooses one response."|6 weeks|The 29 subjects who completed the PGI-I at the six week follow up visit.||participants|||Number
696455|NCT01378065|Secondary|Percentage of Participants With Surgical Success of the Posterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at the12 Month Visit|Percentage of participants with surgical success of the posterior compartment after vaginal reconstruction surgery via Pelvic Organ Prolapse Quantification system (POP-Q) at the 12 month visit. Surgical success is defined as the post-operative point of maximal prolapse being less than 0 cm (i.e. above the hymenal ring).|12 month|The 6 subjects who were treated in the posterior compartment with Restorelle Direct Fix.||percentage of subjects|||Number
696456|NCT01378065|Secondary|Percentage of Participants With Surgical Success of the Posterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at the 6 Month Visit|Percentage of participants with surgical success of the posterior compartment after vaginal reconstruction surgery via Pelvic Organ Prolapse Quantification system (POP-Q) at the 6 month visit Surgical success is defined as the post-operative point of maximal prolapse being less than 0 cm (i.e. above the hymenal ring).|6 month|The 5 subjects who were treated in the posterior compartment with Restorelle Direct Fix and have POP-Q measurement recorded at the six month follow-up visit.||percentage of subjects|||Number
696457|NCT01378065|Secondary|Percentage of Participants With Surgical Success of the Posterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at the 3 Month Visit|Percentage of participants with surgical success of the posterior compartment after vaginal reconstruction surgery via Pelvic Organ Prolapse Quantification system (POP-Q) at the 3 month visit. Surgical success is defined as the post-operative point of maximal prolapse being less than 0 cm (i.e. above the hymenal ring).|3 month|The six subjects who had posterior compartment vaginal reconstruction surgery.||percentage of subjects|||Number
696458|NCT01378065|Secondary|Percentage of Participants With Surgical Success of the Posterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at the 6 Week Visit|Percentage of participants with surgical success of the posterior compartment after vaginal reconstruction surgery via Pelvic Organ Prolapse Quantification system (POP-Q) at the 6 week visit. Surgical success is defined as the post-operative point of maximal prolapse being less than 0 cm (i.e. above the hymenal ring).|6 week|The 6 subjects who were treated in the posterior compartment with Restorelle Direct Fix.||percentage of subjects|||Number
696459|NCT01378065|Secondary|Percentage of Participants With Mesh Exposure/Extrusion After Vaginal Reconstruction Surgery at 12 Months.|"Percentage of participants with anterior and posterior compartment mesh exposure/extrusion after vaginal reconstruction with Restorelle Direct Fix at 12 months. Per the protocol, mesh extrusion is defined as passage gradually out of a body structure or tissue. Mesh exposure is defined as  a condition of displaying, revealing, exhibiting or making accessible e.g. vaginal mesh visualized through separated vaginal epithelium."|12 months|All study subjects.||percentage of subjects|||Number
696460|NCT01378065|Primary|Palpability of the Restorelle Direct Fix A&P|Measured via palpability scale with possible outcomes of none, mild, moderate, or severe.|12 months|All subjects||participants|||Number
696461|NCT01378065|Primary|Palpability of the Restorelle Direct Fix A&P|Measured via palpability scale with possible outcomes of none, mild, moderate, or severe.|6 months|All subjects||participants|||Number
696464|NCT01378065|Secondary|Percentage of Participants With Surgical Success Rates of the Anterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at 12 Months|Percentage of participants with surgical success rates of the anterior compartments after vaginal reconstruction surgery via Pelvic Organ Prolapse Quantification system (POP-Q) at 12 months. Surgical success rate is defined as the post-operative point of maximal prolapse being less than 0 cm (i.e. above the hymenal ring).|12 months|The 27 subjects who were treated with Restorelle Direct Fix in the anterior compartment.||percentage of subjects|||Number
696465|NCT01378065|Secondary|Percentage of Participants With Surgical Success Rates of the Anterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at 6 Months|Percentage of participants with surgical success rates of the anterior compartments after vaginal reconstruction surgery via Pelvic Organ Prolapse Quantification system (POP-Q) at 6 months. Surgical success rate is defined as the post-operative point of maximal prolapse being less than 0 cm (i.e. above the hymenal ring).|6 months|The 27 subjects who were treated with Restorelle Direct Fix in the anterior compartment.||percentage of subjects|||Number
696466|NCT01378065|Secondary|Percentage of Participants With Surgical Success Rates of the Anterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at 3 Months|Percentage of participants with surgical success rates of the anterior compartments after vaginal reconstruction surgery via Pelvic Organ Prolapse Quantification system (POP-Q) at 3 months. Surgical success rate is defined as the post-operative point of maximal prolapse being less than 0 cm (i.e. above the hymenal ring).|3 months|The 27 subjects who were treated with Restorelle Direct Fix in the anterior compartment.||percentage of subjects|||Number
696467|NCT01378065|Secondary|Percentage of Participants With Surgical Success Rates of the Anterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at 6 Weeks|Surgical success rates of the anterior compartments after vaginal reconstruction surgery via Pelvic Organ Prolapse Quantification system (POP-Q) at 6 weeks. Surgical success rate is defined as the post-operative point of maximal prolapse being less than 0 cm (i.e. above the hymenal ring).|6 weeks|The 27 subjects who were treated with Restorelle Direct Fix in the anterior compartment.||percentage of subjects|||Number
696468|NCT01378065|Secondary|Rates of de Novo Dyspareunia|"Percentage of de novo dyspareunia measured via validated Participant Sexual Function Questionnaire-12 (PISQ-12) questionnaire at 12 months. The specific PISQ-12 score was based upon Question 3.5, Do you feel pain during sexual intercourse? The subjects' response was counted as having de novo dyspareunia if the response was sometimes usually or always."|12 months|The 11 sexually active subjects without dyspareunia at baseline. At the 12 month follow-up visit, only 11 subjects were sexually active and thus only 11 subjects completed Question 3.5 on the PISQ-12 questionnaire. Therefore, the number of participants analyzed for this outcome was 11 at the 12 month follow-up visit.||percentage of subjects|||Number
696469|NCT01378065|Secondary|Rates of de Novo Dyspareunia|"Percentage of de novo dyspareunia measured via validated Participant Sexual Function Questionnaire-12 (PISQ-12) questionnaire at six months. The specific PISQ-12 score was based upon Question 3.5, Do you feel pain during sexual intercourse? The subjects' response was counted as having de novo dyspareunia if the response was sometimes usually or always."|6 months|The 12 sexually active subjects without dyspareunia at baseline.||percentage of subjects|||Number
696470|NCT01378065|Secondary|Rates of de Novo Dyspareunia|"Percentage of de novo dyspareunia measured via validated Participant Sexual Function Questionnaire-12 (PISQ-12) questionnaire at 3 months. The specific PISQ-12 score was based upon Question 3.5, Do you feel pain during sexual intercourse? The subjects' response was counted as having de novo dyspareunia if the response was sometimes usually or always."|3 months|The 12 sexually active subjects without dyspareunia at baseline.||percentage of subjects|||Number
696471|NCT01378065|Secondary|Rates of de Novo Dyspareunia|"Percentage of de novo dyspareunia measured via validated Participant Sexual Function Questionnaire-12 (PISQ-12) questionnaire at 6 weeks. The specific PISQ-12 score was based upon Question 3.5, Do you feel pain during sexual intercourse? The subjects' response was counted as having de novo dyspareunia if the response was sometimes usually or always."|6 weeks|The 12 sexually active subjects without dyspareunia at baseline.||percentage of subjects|||Number
696472|NCT01378065|Primary|Palpability of the Restorelle Direct Fix Anterior and Posterior (A&P)|Measured via palpability scale with possible outcomes of none, mild, moderate, or severe.|Baseline|All subjects||participants|||Number
696473|NCT01377636|Primary|BIS Change|The BIS scale ranges from 0 to 100. The individual's baseline BIS was measured continuously and was maintained in an anesthetic steady state with minimum variance prior to isoproterenol. A deviation from the mean in excess of 3 points (2 STD) was defined categorically as a positive response and was counted dichotomously.The difference between Pre-BIS and Post-BIS was calculated.|Within 20 minutes of starting isoproterenol infusion|||units on a scale||95% Confidence Interval|Mean
696474|NCT01377636|Other Pre-specified|Number of Participants Who Developed Ischemia or ST Segment Changes|The (ST) segment on the EKG was monitored for changes suggestive of demand ischemia. An observable EKG change compared to baseline was defined categorically as a positive response and was counted dichotomously.|Within 20 minutes of starting isoproterenol infusion|||participants|||Number
696475|NCT01377636|Other Pre-specified|Number of Participants With New Arrhythmia During Steady State.|Increasing doses of isoproterenol (5,10,15,20 mcg/minute) were administered to patients undergoing catheter ablation for atrial fibrillation after return to sinus rhythm. If a non-sinus arrhythmia resulted from the infusion, the arrhythmia was defined categorically as a positive response and was counted dichotomously.|Within 20 minutes of start of isoproterenol|||participants|||Number
696476|NCT01377636|Other Pre-specified|Number of Participants With Amnesia or No Recall During Steady State|Increasing doses of isoproterenol (5,10,15,20 mcg/minute) were administered to patients undergoing catheter ablation for atrial fibrillation. Specific pre-determined test words were spoken to the subject during administration of isoproterenol. After anesthesia, patients were tested for possible recall of those specific words. If no words were recalled, the result was categorically defined as amnesia.|Within one hour of completing anesthesia|||participants|||Number
696477|NCT01377636|Other Pre-specified|Number of Participants With Change in Blood Pressure|Non-Invasive Blood Pressure (NIBP) is measured routinely as part of an anesthetic. Pre- and Post Blood Pressures where noted. An increase or decrease of 10 percent or more was defined as a significant change in systolic blood pressure.|Within 20 minutes of starting isoproterenol infusion|||participants|||Number
696480|NCT01377636|Secondary|Number of Participants With Spontaneous Musculoskeletal Movement|Increasing doses of isoproterenol (5,10,15,20 mcg/minute) were administered to patients undergoing catheter ablation for atrial fibrillation. Patients under steady state total venous anesthesia (TIVA) with propofol and remifentanil infusions with BIS around 50 normally do not move even in the absence of neuromuscular blockade. Spontaneous movement appearing like restlessness during sleep is unusual. Several patients under anesthesia after isoproterenol appear to wake up and move spontaneously.|Within 20 minutes of starting isoproterenol infusion|||participants|||Number
696481|NCT01377636|Primary|Number of Participants With an Increase in BIS Readings During Steady State|Increasing doses of isoproterenol (5,10,15,20 mcg/minute) were administered to patients undergoing catheter ablation for atrial fibrillation. BIS levels were measured continuously before and after isoproterenol administration. Number of participants with increase in BIS reading during anesthetic steady state are reported below. The BIS scale ranges from 0 to 100. The individual's baseline BIS was measured continuously and was maintained in an anesthetic steady state with minimum variance prior to isoproterenol. A deviation from the mean in excess of 3 points (2 STD) was defined categorically as a positive response and was counted dichotomously.|During time of Electrophysiology (EP) studies.|||participants|||Number
696482|NCT01377623|Secondary|Concentration of IL-8||Post-operative Day 1|||pg/ml||Inter-Quartile Range|Median
696483|NCT01377623|Secondary|Concentration of IL-6||Post-operative Day 1|||pg/ml||Inter-Quartile Range|Median
696484|NCT01377623|Secondary|Concentration of IL-1a||Post-operative Day 1|||pg/ml||Inter-Quartile Range|Median
696485|NCT01377623|Secondary|Concentration of TNF-alpha||Post-operative Day 1|||pg/ml||Inter-Quartile Range|Median
696486|NCT01377623|Primary|Quality of Recovery Score (QoR-40)|The QoR-40 is a 40 item questionnaire in which each question is answered with a score of 1-5. QoR-40 scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery).|Post-operative Day 3|||units on a scale||Standard Deviation|Mean
696487|NCT01377584|Secondary|Continuous Positive Airway Pressure (CPAP) Adherence|Adherence will be measured as the amount of time that the CPAP machine is turned on and maintained at prescribed pressure. The latter number represents the amount of time power is on and the mask is positioned properly on the face. All patients will be using a CPAP machine with remote monitoring capabilities. Adherence reports are automatically uploaded to a secure data center daily. Adherence data can be accessed through the web-based patient compliance management system, EncoreAnywhere.|one week, one month, and 3 months after CPAP initiation|||hours of use||Standard Deviation|Mean
696488|NCT01377584|Primary|Sleep Quality|The Pittsburgh Sleep Quality Index (PSQI) is a 19 item questionnaire that measures self-reported sleep quality and disturbances over the last 1 month time period. The questionnaire measures 7 components of sleep quality: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. A global PSQI score is obtained by summing the 7 component scores (range = 0-21). A PSQI global score > 5 indicates a poor sleeper.|baseline and 3 months after CPAP initiation|||units on a scale||Standard Deviation|Mean
696489|NCT01377584|Primary|Sleep-related Functional Outcomes|The Functional Outcomes of Sleep Questionnaire-10 is 10-item questionnaire assesses the impact of sleep disorders of excessive sleepiness on multiple activities of everyday living. Scores for five domains of functioning (e.g., activity, vigilance, intimacy and sexual relationships, general productivity, and social outcome) are obtained. Each domain score ranges from 1 to 4 (1 indicating more difficulty). The total score is derived by calculating the mean of the domain scores and multiplying by five. The total score ranges from 5 to 20, with higher scores indicating greater functioning.|baseline and 3 months after CPAP initiation|||units on a scale||Standard Deviation|Mean
696490|NCT01377584|Primary|Daytime Sleepiness|The Epworth Sleepiness Scale is an 8-item questionnaire that assesses daytime sleepiness.Total scores range from 0 to 24. A score of > 10 indicates excessive daytime sleepiness.|baseline and 3 months after CPAP initiation|||units on a scale||Standard Deviation|Mean
696491|NCT01377480|Primary|Percentage of Participants With a Successful Response as Measured by Qualitative Polymerase Chain Reaction|Blood samples were collected for qualitative polymerase chain reaction (PCR) assay for Trypanosoma cruzi deoxyribonucleic acid (DNA). Successful response was defined as a negative qualitative PCR value at the Day 180 follow up visit.|Day 180|The Full Analysis Population included all randomized subjects who received at least one dose of study drug.||Percentage of participants||95% Confidence Interval|Number
696492|NCT01377467|Other Pre-specified|Percent Change From Baseline in Cortical Thickness (Ct.Th) at the Distal Radius|Cortical thickness was measured via HR-pQCT (Xtreme CT) at the distal radius and was expressed as mm.|Baseline and month 12|Subgroup of patients (n=24) who participated in the HR-pQCT (Xtreme CT) subprotocol.||Percent change||95% Confidence Interval|Median
696493|NCT01377467|Other Pre-specified|Percent Change From Baseline in Trabecular Volumetric Bone Mineral Densitiy (Tb.vBMD) at the Distal Radius|Volumetric BMD (vBMD) was measured via HR-pQCT (Xtreme CT) at the distal radius and was expressed as mg HA/cm3.|Baseline and month 12|Subgroup of patients (n=24) who participated in the HR-pQCT (Xtreme CT) subprotocol.||Percent change||95% Confidence Interval|Median
696494|NCT01377467|Other Pre-specified|Percent Change From Baseline in Cortical Volumetric Bone Mineral Densitiy (Ct.vBMD) at the Distal Radius|Volumetric BMD (vBMD) was measured via HR-pQCT (Xtreme CT) at the distal radius and was expressed as mg HA/cm3.|Baseline and month 12|Subgroup of patients (n=24) who participated in the HR-pQCT (Xtreme CT) subprotocol.||Percent change||95% Confidence Interval|Median
696495|NCT01377467|Other Pre-specified|Percent Change From Baseline in Total Volumetric Bone Mineral Densitiy (Tot.vBMD) at the Distal Radius|Volumetric BMD (vBMD) was measured via HR-pQCT (Xtreme CT) at the distal radius and was expressed as mg HA/cm3.|Baseline and month 12|Subgroup of patients (n=24) who participated in the HR-pQCT (Xtreme CT) subprotocol.||Percent change||95% Confidence Interval|Median
696496|NCT01377467|Other Pre-specified|Percent Change From Baseline in Cortical Thickness (Ct.Th) at the Distal Tibia|Cortical thickness was measured via HR-pQCT (Xtreme CT) at the distal tibia and was expressed as mm.|Baseline and month 12|Subgroup of patients (n=24) who participated in the HR-pQCT (Xtreme CT) subprotocol.||Percent change||95% Confidence Interval|Median
696497|NCT01377467|Other Pre-specified|Percent Change From Baseline in Trabecular Volumetric Bone Mineral Densitiy (Tb.vBMD) at the Distal Tibia|Volumetric BMD (vBMD) was measured via HR-pQCT (Xtreme CT) at the distal tibia and was expressed as mg HA/cm3.|Baseline and month 12|Subgroup of patients (n=24) who participated in the HR-pQCT (Xtreme CT) subprotocol.||Percent change||95% Confidence Interval|Median
696499|NCT01377467|Other Pre-specified|Percent Change From Baseline in Total Volumetric Bone Mineral Densitiy (Tot.vBMD) at the Distal Tibia|Volumetric BMD (vBMD) was measured via HR-pQCT (Xtreme CT) at the distal tibia and was expressed as mg HA/cm3.|Baseline and month 12|Subgroup of patients (n=24) who participated in the HR-pQCT (Xtreme CT) subprotocol.||Percent change||95% Confidence Interval|Median
696500|NCT01377467|Other Pre-specified|1,25-(OH)2 Vitamin D3|Blood levels of 1,25-(OH)2 vitamin D3 were measured as ng/L|baseline, months 3, 6, and 12|For this endpoint, an available case analysis was performed, i.e., all randomised patients with valid data at all time points were included.||ng/L||95% Confidence Interval|Least Squares Mean
696501|NCT01377467|Other Pre-specified|25-OH-vitamin D3|Blood levels of 25-OH-vitamin D3 were measured as microgramm/L|baseline, months 3, 6, and 12|For this endpoint, an available case analysis was performed, i.e., all randomised patients with valid data at all time points were included.||microgramm/L||95% Confidence Interval|Least Squares Mean
696502|NCT01377467|Other Pre-specified|Blood Levels of PTH (ng/L) at Baseline and Months 3, 6, and 12|Blood levels of PTH (ng/L) were measured at baseline and at months 3, 6, and 12|baseline and months 3, 6, and 12|For this endpoint, an available case analysis was performed, i.e., all randomised patients with valid data at all time points were included.||ng/L||95% Confidence Interval|Least Squares Mean
696503|NCT01377467|Other Pre-specified|Blood Levels of Phosphate (mmol/L) at Baseline and Months 0.5, 1, 2, 3, 6, 12|Blood levels of phosphate (mmol/L) were measured at baseline and at months 0.5, 1, 2, 3, 6, 12|baseline, months 0.5, 1, 2, 3, 6, 12|For this endpoints, an available case analysis was performed, i.e., all randomised patients with valid data at all time points were included.||mmol/L||95% Confidence Interval|Least Squares Mean
696504|NCT01377467|Other Pre-specified|Blood Levels of Calcium (mmol/L) at Baseline and Months 0.5, 1, 2, 3, 6, 12|Blood levels of calcium (mmol/L) were measured at baseline and at months 0.5, 1, 2, 3, 6, and 12|baseline, months 0.5, 1, 2, 3, 6, 12|For this endpoints, an available case analysis was performed, thus all randomised patients with valid data at all time points were included.||mmol/L||95% Confidence Interval|Least Squares Mean
696505|NCT01377467|Secondary|P1NP at Baseline and Months 3, 6 and 12|Blood concentrations of P1NP were measured in microgram/L|baseline, month 3, month 6, and month 12|For this endpoints, an available case analysis was performed, i.e., all randomised patients with valid data at all time points were included.||microgram/L||95% Confidence Interval|Least Squares Mean
696506|NCT01377467|Secondary|Beta-CTX at Baseline and Months 3, 6 and 12|Blood concentrations of beta-CTX (microgram/L)|baseline, month 3, month 6, and month 12|For this endpoint, an available case analysis was performed, i.e., all randomised patients with valid data at all time points were included.||microgram/L||95% Confidence Interval|Least Squares Mean
696507|NCT01377467|Secondary|Percent Change in BMD at the Femoral Neck From Baseline to Month 6|The femoral neck BMD was measured via DXA and was expressed in g/cm2 hydroxylapatite|Baseline and month 6|The intention-to-treat (ITT) population was used for the analysis of this endpoint, i.e. all subjects were included in the analysis that have been randomized to the control group or to the denosumab group. Missing values were replaced with a last-value-carried-forward approach (LVCF).||percent change||Standard Deviation|Mean
696508|NCT01377467|Secondary|Percent Change in BMD at the Total Hip From Baseline to Month 6|The total hip BMD was measured via DXA and was expressed in g/cm2 hydroxylapatite|Baseline and month 6|The intention-to-treat (ITT) population was used for the analysis of this endpoint, i.e. all subjects were included in the analysis that have been randomized to the control group or to the denosumab group. Missing values were replaced with a last-value-carried-forward approach (LVCF).||percent change||Standard Deviation|Mean
696509|NCT01377467|Secondary|Percent Change in BMD at the Total Lumbar Spine From Baseline to Month 6|The total lumbar spine BMD was measured via DXA and was expressed in g/cm2 hydroxylapatite.|Baseline and month 6|The intention-to-treat was used for the analysis of this endpoint, i.e. all subjects were included in the analysis that have been randomized to the control group or to the denosumab group. Missing values were replaced with a last-value-carried-forward approach (LVCF).||percent change||Standard Deviation|Mean
696510|NCT01377467|Secondary|Percent Change in BMD at the Femoral Neck From Baseline to Month 12|The total femoral neck BMD was measured via Dual Energy X-ray Absorptiometry (DXA) and was expressed in g/cm2 hydroxylapatite|Baseline and month 12|The intention-to-treat (ITT) was used for the analysis of this endpoint, i.e. all subjects were included in the analysis that have been randomized to the control group or to the denosumab group. Missing values were replaced with a last-value-carried-forward approach (LVCF).||percent change||Standard Deviation|Mean
696511|NCT01377467|Secondary|Percent Change in BMD at the Total Hip From Baseline to Month 12|The total hip BMD was measured via Dual Energy X-ray Absorptiometry (DXA) and was expressed in g/cm2 hydroxylapatite|Baseline and month 12|The intention-to-treat (ITT) population was used for the analysis of this endpoint, i.e. all subjects were included in the analysis that have been randomized to the control group or to the denosumab group. Missing values were replaced with a last-value-carried-forward approach (LVCF).||percent change||Standard Deviation|Mean
696512|NCT01377467|Primary|Percent Change in BMD at the Total Lumbar Spine From Baseline to Month 12|The total lumbar spine BMD was measured via Dual Energy X-ray Absorptiometry (DXA) and was expressed in g/cm2 hydroxylapatite|Baseline and month 12|The intention-to-treat (ITT) population was used for the primary efficacy analysis, i.e. all subjects were included that have been randomized to the control group or to the denosumab group. Missing values were replaced with a last-value-carried-forward approach (LVCF).||percent change||Standard Deviation|Mean
696513|NCT01377441|Secondary|Quality of Recovery Score (QoR-40).|The secondary outcome parameters will be the quality of recovery score (QoR-40) to measure quality of recovery from surgery, a simple fatigue scale, digits forward and backward, and the global depression schedule. Forty questions in five dimensions will be scored by patients on a five-point Likert scale. Seven point fatigue scales (in- and out-patient) is often used to assess progress of recovery in head trauma patients. Metrics will be administered on at the baseline visit and or on the day of surgery and on postoperative days 1, 2, 4 and 6.|48h||||||
696526|NCT01377012|Secondary|Extension Phase: Proportion of Subjects Achieving ACR/(EULAR) Remission|ACR/EULAR remission is defined as SDAI ≤ 3.3, where SDAI is a measure of disease activity in RA based on 28 tender and swollen joint counts, CRP, Physician and Patient's Global Assessments of Disease|up to week 260|The outcome measures were not analyzed, as a result of the lack of efficacy found in study AIN457F2309 and as per changes to the planned analysis plan for CAIN457f2302/E1|||||
696514|NCT01377441|Primary|Concentrations of the Cytokines Tumor Necrosis Factor Alpha (TNF-alpha), Interleukin IL-1Beta (IL-1Beta), IL-2, IL-6, IL-10, and Interferon-gamma (IFN-gamma) as Well as Prostaglandin E2 at Different Time Points.|Concentration of the cytokines TNF-alpha, IL-1Beta, IL-2, IL-6, IL-10, and IFN-gamma as well as prostaglandin E2 at different time points will be our primary outcome. Changes in mediator levels in the IV ibuprofen versus placebo groups will be compared. Plasma samples will be collected before administration of any drug (after placement of IV lines), at the end of the surgery, and on the first postoperative day.|48h|Unfortunately, due to major flooding at our site, due to Hurricane Sandy, all data and samples for this study were lost. Therefore, it was impossible to analyze any data for this study.|||||
696515|NCT01377402|Secondary|Participants With Cardiac Events During Follow-up.|Cardiovascular Death. Myocardial infarctions (re-MIs) defined according to WHO criteria of 1979.|2-5 years|||Participants|||Number
696516|NCT01377402|Primary|Total Mortality.|Mortality for any reason|2-5 years|Patients with suspected ACS||participants|||Number
696517|NCT01377233|Secondary|Clinical Global Impression Improvement Scale (CGI-I)|The CGI-I provides the clinician’s impression of the patient’s improvement (or worsening). The clinician assesses the patient’s condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). In all cases, the assessment is made independent of whether the rater believes the improvement is drug-related or not.|8 weeks post-baseline (3 weeks open-label period plus 5 weeks double-blind period)|All patients who were randomized to the double-blind study period, who took at least one dose of drug, and who had at least one valid PANSS assessment were included in the full analysis set (FAS)||units on a scale||Standard Deviation|Mean
696518|NCT01377233|Secondary|Clinical Global Impression Severity Scale (CGI-S) Change From Baseline|The CGI-S provides the clinician’s impression of the patient’s current state of mental illness. The clinician uses their clinical experience of this patient population to rate the severity of the patient’s current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients).|8 weeks post-baseline (3 weeks open-label period plus 5 weeks double-blind period)|All patients who were randomized to the double-blind study period, who took at least one dose of drug, and who had at least one valid PANSS assessment were included in the full analysis set (FAS)||units on a scale||Standard Error|Mean
696519|NCT01377233|Secondary|Positive and Negative Syndrome Scale (PANSS) Total and Subscales Change From Baseline|The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 that indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. The PANSS total score was the sum of the rating scores for 7 positive subscale items, 7 negative subscale items, and 16 general psychopathology subscale items from the PANSS panel. PANSS Total Score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|8 weeks post-baseline (3 weeks open-label period plus 5 weeks double-blind period)|All patients who were randomized to the double-blind study period, who took at least one dose of drug, and who had at least one valid PANSS assessment were included in the analysis.||units on a scale||Standard Error|Mean
696520|NCT01377233|Primary|Number of Patients With Adverse Events as a Measure of Safety and Tolerability|Number of patients with treatment-emergent adverse events during each of the two study periods plus corresponding safety follow-up period. Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total)|11 weeks for open-label period; 13 weeks for double-blind period|Adverse events for the 46 patients enrolled in the open-label period are reported in the first (open-label) study arm. Adverse events for the 42 patients (out of the 46 enrolled) who were subsequently randomized to the double-blind period are reported across the last four (randomized) study arms.||participants|||Number
696521|NCT01377194|Secondary|Change in Sheehan Disability Scale (SDS) Total Score|The Sheehan Disability Scale (SDS) is a 3-item clinician-rated questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. All items are rated on an 11-point continuum (0 = no impairment to 10 = most severe) with the total SDS score ranging from 0 (no impairment) to 30 (most severe)|From Baseline to Week 8|Of the 568 patients randomized to receive double-blind treatment, 562 patients received at least 1 dose of treatment and were included in the Safety Population, and 557 patients received at least 1 dose of treatment and had at least 1 postbaseline MADRS assessment and were included in the ITT Population.||units on a scale||Standard Error|Least Squares Mean
696522|NCT01377194|Primary|Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score - Mixed-effects Model for Repeated Measures (MMRM) Analysis.|The Montgomery-Asberg Depression Rating Scale (MADRS) rates patients on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest. Each item was scored on a 7-point scale. A score of 0 indicated the absence of symptoms, and a score of 6 indicated symptoms of maximum severity. The minimum overall score possible was 0 (absence of symptoms), with a maximum overall score of 60 (maximum severity).|From Baseline to Week 8|Of the 568 patients randomized to receive double-blind treatment, 562 patients received at least 1 dose of treatment and were included in the Safety Population, and 557 patients received at least 1 dose of treatment and had at least 1 postbaseline MADRS assessment and were included in the ITT Population.||Units on a scale||Standard Deviation|Mean
696523|NCT01377012|Primary|Extension Phase: Percentage of Patients Achieving a American College of Rheumatology Response ACR20, ACR50 and ACR70||up to week 260|The outcome measures were not analyzed, as a result of the lack of efficacy found in study AIN457F2309 and as per changes to the planned analysis plan for CAIN457f2302/E1|||||
696524|NCT01377012|Secondary|Extension Phase: Immunogenicity Against Secukinumab||up to week 260|The outcome measures were not analyzed, as a result of the lack of efficacy found in study AIN457F2309 and as per changes to the planned analysis plan for CAIN457f2302/E1|||||
696525|NCT01377012|Secondary|Extension Phase: Changes in Baseline of Quality of Life (Qol) Outcomes Measured by Medical Outcome Short Form SF-36 v2|Short Form Health Survey (SF-36) consists of eight subscales that can be scored individually: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Two overall summary scores, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) also can be computed.|Baseline, up to week 260|The outcome measures were not analyzed, as a result of the lack of efficacy found in study AIN457F2309 and as per changes to the planned analysis plan for CAIN457f2302/E1|||||
696527|NCT01377012|Secondary|Extension Phase: Proportion of Subjects Achieving Low Disease Activity and Good/Moderate European League Against Rheumatism (EULAR) Responses|Low Disease Activity is defined as DAS28 ≤ 3.2. EULAR good response requires an improvement of > 1.2 in the DAS28 score with a present score of ≤3.2; EULAR moderate response is defined as an improvement of >0.6 to ≤1.2 in DAS28 and a present score of ≤5.1; or an improvement of >1.2 and a present score of >3.2.|up to week 260|The outcome measures were not analyzed, as a result of the lack of efficacy found in study AIN457F2309 and as per changes to the planned analysis plan for CAIN457f2302/E1|||||
696528|NCT01377012|Secondary|Extension Phase: Change in Baseline of RA Disease Activity as Measured by Disease Activity Score (DAS28)|"The DAS28 score is a measure of RA disease activity calculated using variables such as swollen joint count, the Erythrocyte Sedimentation Rate (ESR) and patient reported assessment of health.
Using this data, the DAS28 calculation provides a number on a scale from 0-10 indicating the current activity of a patient's RA. A DAS28 score above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity. Remission is achieved by a DAS28 score lower than 2.6."|week 260|The outcome measures were not analyzed, as a result of the lack of efficacy found in study AIN457F2309 and as per changes to the planned analysis plan for CAIN457f2302/E1|||||
696529|NCT01377012|Primary|Core Study: Percentage of Participants Achieving an American College of Rheumatology Response 20 (ACR20) at Week 24|ACR20 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 20% improvement in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient’s assessment of RA pain, patient’s global assessment of disease activity, physician’s global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire [HAQ-DI] score), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR). The ACR20 response results at week 24 used non-responder imputation.|Week 24|The Full analysis set (FAS) comprised all patients who were randomized and to whom study treatment had been assigned.||Percentage of Participants|||Number
696530|NCT01377012|Secondary|Core Study Percentage of Patients Achieving Major Clinical Response (Continuous Six-month Period of ACR70 Response During the 1 Year Period) at Week 52|The major clinical response is defined as continuous six-month period of ACR70 response during the 1 year period. ACR70 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 70% improvement in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient’s assessment of RA pain, patient’s global assessment of disease activity, physician’s global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire [HAQ-DI] score), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR). The ACR70 response results at week 24 used non-responder imputation.|52 week|The Full analysis set (FAS) comprised all patients who were randomized and to whom study treatment had been assigned. N=The total number of subjects in the treatment groups with evaluation||Percentage of Participants|||Number
696531|NCT01377012|Secondary|Core Study: Change From Baseline at Week 24 in Van Der Heijde Total Modified Sharp Score|Separate radiographs of each hand/wrist and each foot were taken at basline and Week 24. The radiographs were assessed using the van der Heijde modified Sharp score. The change in the Van der Heijde modified Sharp score is calculated against the baseline value. The total van der Heide modified Sharp score goes from 0 to 448, the bigger the change, the worse it is for the patient.|Week 24|Participants from the full analysis set were considered for the analysis. Participants with measurements at both baseline and week 24 were analyzed.||Score on a scale||Standard Error|Mean
696532|NCT01377012|Secondary|Core Study: Change From Baseline and Week 24 in Stanford Health Assessment Questionnaire Disability Index (HAQ-DI)|"The HAQ-DI assesses a subject's level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities. There are 20 questions in 8 categories of functioning including dressing, rising, eating, walking, hygiene, reach, grip and usual activities. The stem of each item asks 'Over the past week, are you able to... perform a particular task'. Each item is scored on a 4 point scale from 0 - 3, representing normal, no difficulty (0), some difficulty (1), much difficulty (2) and unable to do (3). The disability index score is calculated as the mean of the available category scores, ranging from 0 to 3. A negative change from baseline indicates improvement."|Baseline, Week 24|Participants from the full analysis set were considered for the analysis. Participants with measurements at both baseline and week 24 were analyzed. The full analysis set was comprised of all randomized participants (excluding mis-randomized participants) who were assigned to study treatment.||Score on a scale||Standard Error|Least Squares Mean
696533|NCT01376908|Secondary|Population PK Parameter: Time to Maximum Plasma Concentration (Tmax)||Up to Week 26|Tmax could not be calculated from the model derived parameters because shrinkage was over 20% for V/F and interindividual variability could not be estimated for Ka.|||||
696534|NCT01376908|Secondary|Population PK Parameter: Maximum Observed Plasma Concentration (Cmax)||Up to Week 26|Cmax could not be calculated from the model derived parameters because shrinkage was over 20% for V/f and interindividual variability could not be estimated for absorption rate constant (Ka).|||||
696535|NCT01376908|Secondary|Population PK Parameter: Terminal Elimination Half-life (t1/2)|The t1/2 was defined as the time required for plasma concentration of drug to decrease 50 percent (%) in the final stage of elimination. Since t1/2 could not be obtained from non-compartmental analysis because of sparse data, t1/2 was estimated as Log(2)*(V/F)/(CL/F), where V/F & CL/F were the population apparent central Volume & clearance, estimated from population PK model. The reason for pooling subjects receiving Kuvan & subjects with Phe-restricted Diet was to facilitate the estimation of baseline endogenous value of BH4 which can only observed in subjects not receiving treatment. Ignoring this baseline endogenous value would have led biased stimated of the Kuvan PK parameters. This pooling assumes that the addition of Kuvan does not confound the BH4 measurements in these analyses as a consequence the population PK parameters describing the PK of BH4 are the same for the 2 arms and so cannot be presented in terms of per arm/per treatment group based as per the planned analysis.|Weeks 5 to 12|All enrolled subjects for whom at least one adequately documented BH4 concentration value and dose record were included in the population PK analysis. ‘N’ (number of subjects analyzed) =subjects evaluable for this outcome measure.||hours|||Number
714979|NCT00247273|Secondary|Number of Participants With New Vertebral Fracture at Month 12, ITT Population|At least 1 new fractured vertebra|Baseline to Month 12|ITT||Participants|||Number
696536|NCT01376908|Secondary|Population PK Parameter: Area Under the Plasma Concentration Curve, Time 0 to Infinity (AUC [0-infinity])|AUC [0-infinity] was estimated by determining total area under the curve of the concentration versus time curve extrapolated to infinity. Since AUC could not be obtained from non-compartmental analysis because of sparse data, AUC = Dose/(CL/F); CL/F was population apparent clearance estimated from the population PK model, & Dose the actual total dose received by the patient on one dosing interval. The reason for pooling subjects receiving Kuvan &subjects with Phe-restricted Diet was to facilitate estimation of baseline endogenous value of BH4 which can only be observed in subjects not receiving treatment. Ignoring this baseline endogenous value would have led to biased estimated of Kuvan PK parameters. This pooling assumes that the the addition of Kuvan does not confound the BH4 measurements in these analyses as a consequence the population PK parameters describing the PK of BH4 were same for the 2 arms and cannot be presented per arm/per treatment group as per planned analysis.|Weeks 5 to 12|All enrolled subjects for whom at least one adequately documented BH4 concentration value and dose record were included in the population PK analysis. ‘N’ (number of subjects analyzed) =subjects evaluable for this outcome measure.||microgram*hour per liter(mcg*hour/liter)||Standard Deviation|Mean
696537|NCT01376908|Secondary|Population PK Parameter: Apparent Volume of Distribution (V/f)|V/f is defined as the distribution of a medication between the plasma and the rest of the body after the dose. It is the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of the drug. The reason for pooling subjects receiving Kuvan and subjects with Phe-restricted Diet was to facilitate the estimation of baseline endogenous value of BH4 which can only be observed in subjects not receiving the treatment. Ignoring this baseline endogenous value would have led to biased stimated of the Kuvan PK parameters. This pooling assumes that the addition of Kuvan does not confound the BH4 measurements in these analyses as a consequence the population PK parameters describing the PK of BH4 are the same for the 2 arms and so cannot be presented in terms of per arm/per treatment group based as per the planned analysis.|Weeks 5 to 12|All enrolled subjects for whom at least one adequately documented BH4 concentration value and dose record were included in the population PK analysis. 'N' (number of subjects analyzed) =subjects evaluable for this outcome measure.||liter||Standard Error|Mean
696538|NCT01376908|Secondary|Population Pharmacokinetic (PK) Parameter: Apparent Clearance (CL/f)|CL/f is the rate at which a drug is removed from the body via renal, hepatic and other clearance pathways.The reason for pooling subjects receiving Kuvan and subjects with Phe-restricted Diet was to facilitate the estimation of baseline endogenous value of BH4 which can only be observed in subjects not receiving the treatment. Ignoring this baseline endogenous value would have led to biased stimated of the Kuvan PK parameters. This pooling assumes that the addition of Kuvan does not confound the BH4 measurements in these analyses as a consequence the population PK parameters describing the PK of BH4 are the same for the 2 arms and so cannot be presented in terms of per arm/per treatment group based as per the planned analysis.|Weeks 5 to 12|All enrolled subjects for whom at least one adequately documented BH4 concentration value and dose record were included in the population PK analysis. 'N' (number of subjects analyzed) =subjects evaluable for this outcome measure.||liter per hour||Standard Error|Mean
696539|NCT01376908|Secondary|Number of Samples With Phenylalanine Hydroxylase (PAH) Gene Mutations|The DNA samples received were quantified by using a nanophotometer, and were aliquoted to a concentration of 20 nanogram/microliter DNA and aliquots from each sample were distributed to one 96-well plate. All samples were Sanger sequenced regarding exons 1 to 13 of the PAH gene in forward direction using the DNAs in the 96-well plate. All samples showing variants were Sanger sequenced regarding the concerned exon in reverse direction using DNA from the original tube. All samples showing a homozygous mutation were analyzed by MLPA. All samples showing only 1 mutation were analyzed by MLPA. All samples showing only 1 or no mutation were resequenced completely (exons 1 to 13) in both directions.|Screening (within 42 days prior to Day 1 of the 26-week study period)|Analysis population included subjects who signed pharmacogenetics (PGx) informed consent and whose samples were available for analysis. Out of 109 subjects screened for the study, 77 PGx informed consent forms were signed and 73 samples were analyzed.||Sample|||Number
696540|NCT01376908|Secondary|Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)||Baseline, Weeks 4, 8, 12, 16, 20, and 26|"Intention-to-treat (ITT) population consisted of all the randomized subjects at the start of the study and were analyzed according to the group allocated. n signifies number of evaluable subjects in the specified categories for each reporting group, respectively."||mmHg||Standard Deviation|Mean
696541|NCT01376908|Secondary|Dietary Phe Tolerance During Extension Period|Phe tolerance was defined as the amount of dietary Phe ingested (mg/kg/day) while maintaining blood Phe levels within the selected therapeutic target range (defined as >=120 to <360 mcmol/L).|Every 6 months during 3 year extension period or until product is commercially approved|The extension period of this study is ongoing. Data will be provided after completion of extension period i.e first quarter 2017|||||
696542|NCT01376908|Secondary|Number of Subjects With Hypophenylalanemia|Hypophenylalanemia is defined as the condition of blood Phe levels <120 mcmol/L.|Week 26|Safety population consisted of all subjects who had some safety assessment data available (at least one visit in vital signs, AE or laboratory results) in the Study Period and who received at least one dose of Kuvan in the Study Period, or who were randomized to Phe-restricted diet alone.||Subjects|||Number
696543|NCT01376908|Secondary|Growth Parameters Standard Deviation Scores (SDS)|Growth assessment was performed by monitoring body mass index, height (or length), weight, and maximal occipital-frontal head circumference (MOFHC). Supine length was measured up to 2 years of age thereafter standing height was measured unless subject was unable to stand upright, in which case supine length was measured. Respective parameter SDS was calculated as the value of parameter minus reference mean value of parameter divided by standard deviation of the reference population.|Baseline, Weeks 4, 8, 12, 16, 20, and 26|"Intention-to-Treat (ITT) population consisted of all subjects who were randomized at the start of the Study Period and analyzed according to the group allocated. n signifies number of evaluable subjects in the specified categories for each reporting group, respectively."||SDS||Standard Deviation|Mean
696602|NCT01376362|Secondary|Change in Excess Central Macular Thickening in the Study Eye, as Measured by Optical Coherence Tomography (OCT), at Week Two Compared to Baseline|Central macular thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|Baseline and 2 Weeks|||µm||Standard Deviation|Mean
696544|NCT01376908|Secondary|Neurodevelopmental Status Assessed Using Bayley III Scales of Infant and Toddler Development|Neurodevelopmental assessments was done using the following age-dependent scales: Bayley III for subjects less than (<) 3.5 years of age and WPPSI III for subjects greater than or equal to (>=) 3.5 to <4 years of age, based on following scores: adaptive behavior composite (ABC) score, cognitive composite (CC) score, language composite (LC) score, motor composite (MC) score., and social-emotional composite (SEC) score. Composite scores ranged from 40 (very poor) to 160 (excellent) and are classified as following: >=115: accelerated performance; 85-114: development within normal limits; 70-84: mildly delayed development; less than or equal to (<=) 69: significant delayed development.|Baseline and Week 26|"Intention-to-Treat (ITT) population consisted of all subjects who were randomized at the start of the Study Period and analyzed according to the group allocated. n signifies number of evaluable subjects in the specified categories, for each reporting group, respectively."||Units on a scale||Standard Deviation|Mean
696545|NCT01376908|Secondary|Number of Subjects With Normal Neuromotor Developmental Milestones Assessed Using Denver Developmental Scale (DDS)|"Subjects with normal neuromotor development were assessed by standardized developmental milestones using a parent/guardian report form in the following areas: fine motor, gross motor, language, and personal-social using DDS Test. DDS Test is a widely used to examine the developmental progress of 0-6 years of children. The scale reflects what percentage of a certain age group is able to perform a certain task. Tasks are grouped into 4 categories (social contact, fine motor skill, language, and gross motor skill) and include items such as smiles spontaneously (performed by 90% of three-month-olds), knocks 2 building blocks against each other (90% of 13-month-olds), speaks 3 words other than mom and dad (90% of 21-month-olds), or hops on 1 leg (90% of 5-year-olds). The more items a child fails to perform (passed by 90% of his/her peers), the more likely the child manifests a significant developmental problems."|Baseline, Weeks 12, 26|"Intention-to-Treat (ITT) population consisted of all subjects who were randomized at the start of the Study Period and analyzed according to the group allocated. n signifies number of evaluable subjects in the specified categories, for each reporting group, respectively."||subjects|||Number
696546|NCT01376908|Secondary|Number of Subjects With Any TEAEs, AEs Related to Kuvan, Serious AEs, AEs Leading to Death, and AEs Leading to Discontinuation|An AE was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. Treatment-emergent are events between first dose of study treatment and up to 31 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|From the first dose of study drug administration up to 31 days after the last dose of study drug administration|Safety population included all subjects who either received at least one dose of Kuvan in the study period, or were randomized to Phe-restricted diet alone and who had some safety assessment data available.||subjects|||Number
696547|NCT01376908|Secondary|Change From Baseline in Dietary Phe Tolerance After 26 Weeks|Phe tolerance was defined as the amount of dietary Phe ingested (mg/kg/day) while maintaining blood Phe levels within the selected therapeutic target range (defined as >=120 to <360 mcmol/L).|Baseline and at Week 26 (last observation carried-forward [LOCF])|Intention-to-treat (ITT) population consisted of all the randomized subjects at the start of the study and were analyzed according to the group allocated. ‘n’ signifies number of subjects evaluable for this measure at given time points for each reporting group respectively.||mg/kg/day||Standard Error|Mean
696548|NCT01376908|Secondary|Mean Blood Phe Levels|Mean blood phe levels were defined as the mean of blood phe levels assessed over each 2-week intervals|Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26|Intention-to-treat (ITT) population consisted of all the randomized subjects at the start of the study and were analyzed according to the group allocated. ‘n’ signifies number of subjects evaluable for this measure at given time points for each reporting group respectively.||micromol per liter (mmol/L)||Standard Deviation|Mean
696549|NCT01376908|Primary|Dietary Phenylalanine (Phe) Tolerance at Week 26|Phe tolerance was defined as the amount of dietary Phe prescribed (milligram per kilogram per day [mg/kg/day]) while maintaining blood Phe levels within the selected therapeutic target range (defined as greater than or equal to [>=] 120 to less than [<] 360 micromoles per liter [mcmol/L]).|Week 26|Intention-to-treat (ITT) population consisted of all the randomized subjects at the start of the study and were analyzed according to the group allocated.||mg/kg/day||Standard Error|Mean
696550|NCT01376804|Secondary|Number of Participants With Known Ganciclovir Resistance (Mutations in Either UL54 or UL97 Genes)|All patients with measurable CMV had both UL54 and UL97 genes sequenced to assess for known CMV resistance to ganciclovir.|52 Weeks|All patients meeting the resistance analysis criteria are included into the resistance analysis.||Participants|||Number
696551|NCT01376804|Secondary|Number of Participants With Death||52 Weeks|ITT population included all enrolled patients who had taken at least one dose of study medication.||Participants|||Number
696552|NCT01376804|Secondary|Number of Participants With Graft Loss|Graft loss was defined as the institution of chronic dialysis (at least 6 consecutive weeks), transplant nephrectomy, or retransplantation.|52 Weeks|ITT population included all enrolled patients who had taken at least one dose of study medication.||Participants|||Number
696553|NCT01376804|Secondary|Number of Participants With Biopsy Proven Rejection|Renal biopsies were performed as medically indicated. Biopsies were assessed histologically using the updated Banff criteria 1997.|52 Weeks|ITT population included all enrolled patients who had taken at least one dose of study medication.||Participants|||Number
696554|NCT01376804|Secondary|Number of Participants With Peak Cytomegalovirus (CMV) Viral Load up to Week 52 Post-Transplant|Blood samples were sent to a central lab for the quantitative assessment of CMV viral load (amount of CMV in the blood) by an FDA-approved molecular-based assay. The number of participants in each category is reported in copies/milliliter (CP/mL). CMV DNA is detected in all categories < 150 CP/mL and above.|52 weeks|ITT population included all enrolled patients who had taken at least one dose of study medication.||Participants|||Number
696603|NCT01376362|Secondary|Change in Excess Central Macular Thickening in the Fellow Eye, as Measured by Optical Coherence Tomography (OCT), at Week One Compared to Baseline|Central macular thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|Baseline and 1 Week|||µm||Standard Deviation|Mean
696555|NCT01376804|Secondary|Number of Participants With Cytomegalovirus (CMV) Disease in the First 52 Weeks Post-Transplant as Assessed by the Investigator|A polymerase chain reaction (PCR) based assay or antigenaemia assay was used for the qualitative assessment of CMV viremia by each study center as part of the clinical assessment required for diagnosis of CMV infection. CMV disease included CMV syndrome or tissue invasive CMV. CMV syndrome required fever ≥ 38 degrees Celsius, severe malaise, leukopenia on 2 separate measurements, atypical lymphocytosis ≥ 5%, thrombocytopenia, elevation of hepatic transaminases and presence of CMV in blood. Tissue Invasive CMV required evidence of localized CMV infection in a biopsy or other appropriate symptom and relevant symptoms or signs of organ dysfunction.|52 weeks|Intent-to-treat (ITT) population included all enrolled patients who had taken at least one dose of study medication.||Participants|||Number
696556|NCT01376804|Secondary|Number of Participants With Cytomegalovirus (CMV) Infection in the First 52 Weeks Post-Transplant as Assessed by the Investigator|A polymerase chain reaction (PCR) based assay or antigenaemia assay was used for the qualitative assessment of CMV viremia (presence of CMV in the blood) by each study center as part of the clinical assessment required for diagnosis of CMV infection.|52 weeks|Intent-to-treat (ITT) population included all enrolled patients who had taken at least one dose of study medication.||Participants|||Number
696557|NCT01376804|Primary|Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) or Withdrawal Due to AEs|"An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. Pre-existing conditions which worsen during a study were reported as AEs.
A SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant."|52 weeks|Safety Population included all enrolled patients who received at least one dose of study medication and had at least one post-baseline assessment of safety.||Participants|||Number
696558|NCT01376700|Post-Hoc|Number of Inhibitors in Previously Untreated Patients (PUPs) and Minimally Treated Patients (MTPs) - (Only ‘True’ Inhibitors)|"PUPs = no previous FVIII exposure; MTPs ≤4 previous FVIII exposures
’True’ positive inhibitor (PI) = any FVIII inhibitor assay result ≥0.6 Bethesda Units (BU)/mL confirmed by central lab on 2 consecutive samples, ie ≥2 PI results (including first PI test, per study protocol) assessed as either:
i. High FVIII inhibitor titer (>5 BU/mL)
ii. Low FVIII inhibitor titer (≥0.6 - ≤5.0 BU/mL). In addition, to be classified as ‘true’ positive low FVIII inhibitors titer (≥0.6 - ≤5.0 BU/mL), one of following criteria must be met:
a) Lower or absent therapeutic response at infusion of standard replacement doses (“clinically relevant”) as deemed by clinician in charge.
b) Any lab result of binding FVIII antibodies (IgM, IgA, IgG, IgG1, IgG2, IgG3, or IgG4) must be positive.
Classification based on first positive FVIII inhibitor assessment. Inhibitor test result is:
> 5 BU/mL, categorized as high-titer inhibitor
≥0.6 BU/mL but ≤5 BU/mL, categorized as low-titer"|50 exposure days to ADVATE|Safety Analysis Set||inhibitors|||Number
696559|NCT01376700|Post-Hoc|Number of Participants With Factor VIII (FVIII) Inhibitors by Inhibitor Type (Only ‘True’ Inhibitors)|"’True’ positive inhibitor (PI) defined as any FVIII inhibitor assay result ≥0.6 Bethesda Units (BU)/mL confirmed by central lab on 2 consecutive samples, ie ≥2 PI results (including first PI test, in accordance with study protocol) assessed as either:
i. High FVIII inhibitor titer (> 5 BU/mL)
ii. Low FVIII inhibitor titer (≥0.6 - ≤5.0 BU/mL). In addition, to be classified as ‘true’ positive low FVIII inhibitors titer (≥0.6 - ≤5.0 BU/mL), one of following criteria must be met:
a) Lower or absent therapeutic response at infusion of standard replacement doses (“clinically relevant”) as deemed by the clinician in charge.
b) Any lab result of binding FVIII antibodies (IgM, IgA, IgG, IgG1, IgG2, IgG3, or IgG4) must be positive.
Classification based on first positive FVIII inhibitor assessment. Inhibitor test result is:
> 5 BU/mL, then categorized as a high-titer inhibitor
≥0.6 BU/mL but ≤5 BU/mL, then categorized as a low-titer."|50 exposure days to ADVATE|Safety Analysis Set||participants|||Number
696560|NCT01376700|Secondary|Number of Serious Adverse Events (SAEs) and Non-serious Adverse Events (Non-SAEs) at Least Possibly Related to ADVATE|Possibly or probably related adverse events|50 exposure days to ADVATE|Safety Analysis Set||adverse events|||Number
696561|NCT01376700|Secondary|FVIII-Specific Antibody Isotype for All Participants at Study Entry and Every 10 Exposure Days (EDs)||50 exposure days to ADVATE|Summary statistics of FVIII-Specific Antibody Isotypes were not performed due to the early termination of the study|||||
696562|NCT01376700|Secondary|Total Factor VIII (FVIII) Consumption by Participant||50 exposure days to ADVATE|Due to the low number of subjects available for evaluation, no statistical tests were performed to assess the total FVIII consumption by participant|||||
696563|NCT01376700|Secondary|Correlation of Known Risk Factors to Factor VIII (FVIII) Inhibitor Formation||50 exposure days to ADVATE|Due to the low number of subjects available for evaluation, no statistical tests were performed to assess associations between known risk factors to inhibitor formation.|||||
696564|NCT01376700|Secondary|Number and Type of Surgeries|"Elective surgery is not allowed during period of first 20 exposure days (EDs)
Peripherally inserted central catheter (PICC)"|50 exposure days to ADVATE|Safety Analysis Set||surgeries|||Number
696565|NCT01376700|Secondary|Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)|"Nominal Dosing Frequency:
1 time per week
2 times per week
Unknown dosing frequency (UK)
Bleeding Type (BT):
Skin
Muscle and Soft Tissue
Mucosal
Joint
Other
Multiple
Total
Bleeding severity:
Minor
Moderate
Severe
Total"|50 exposure days to ADVATE|Safety Analysis Set||Bleeds|Participants||Number
696566|NCT01376700|Secondary|Number of Participants With Low-titer, High-titer, Transient, and All Factor VIII (FVIII) Inhibitors|"High FVIII inhibitor titer (> 5 Bethesda Unit (BU)/mL)
Low FVIII inhibitor titer (≥0.6 - ≤5.0 BU/mL)"|50 exposure days to ADVATE|Safety Analysis Set||participants|||Number
696567|NCT01376700|Secondary|Number of Exposure Days of Treatment With Advate Prior to First Positive Factor VIII (FVIII) Confirmed Inhibitor Assessment|"Confirmed inhibitor is defined as any FVIII inhibitor assay result equal or greater than 0.6 BU/mL confirmed by the central laboratory on 2 consecutive samples, i.e. at least 2 positive inhibitor results (including the first positive inhibitor test, in accordance with the study protocol) assessed as either:
i. High FVIII inhibitor titer (> 5 BU/mL) or
ii. Low FVIII inhibitor titer (≥0.6 - ≤5.0 BU/mL)."|50 exposure days to ADVATE|Safety Analysis Set||days||Inter-Quartile Range|Median
696568|NCT01376700|Secondary|Number of Participants With Severe Hemophilia A (FVIII ≤ 1%) With Factor VIII (FVIII) Inhibitor Formation Within the First 50 Exposure Days to ADVATE|"Inhibitor testing will be performed in the central laboratory and a non-zero result must be confirmed in the central laboratory as soon as possible, preferably 1 week after inhibitor testing.
Confirmed FVIII inhibitor is defined as any FVIII inhibitor assay result equal or greater than 0.6 Bethesda Units (BU)/mL confirmed by the central laboratory on 2 consecutive samples, i.e. at least 2 positive inhibitor results (including the first positive inhibitor test, in accordance with the study protocol) assessed as either:
i. High FVIII inhibitor titer (> 5 BU/mL) or
ii. Low FVIII inhibitor titer (≥0.6 - ≤5.0 BU/mL)."|50 exposure days to ADVATE|Safety Analysis Set||participants|||Number
696569|NCT01376700|Primary|Number of Participants With Severe and Moderately Severe Hemophilia A (FVIII ≤ 2%) With Factor VIII (FVIII) Inhibitor Formation Within the First 50 Exposure Days to ADVATE|"Inhibitor testing will be performed in the central laboratory and a non-zero result must be confirmed in the central laboratory as soon as possible, preferably 1 week after inhibitor testing.
Confirmed FVIII inhibitor is defined as any FVIII inhibitor assay result equal or greater than 0.6 Bethesda Units (BU)/mL confirmed by the central laboratory on 2 consecutive samples, i.e. at least 2 positive inhibitor results (including the first positive inhibitor test, in accordance with the study protocol) assessed as either:
i. High FVIII inhibitor titer (> 5 BU/mL) or
ii. Low FVIII inhibitor titer (≥0.6 - ≤5.0 BU/mL)."|50 exposure days to ADVATE|"Safety Analysis Set
All study participants had severe Hemophilia A, less than 1% Factor VIII levels. (ie there were no moderately severe hemophilia A participants (FVIII levels >1% to ≤ 2%) in this study."||participants|||Number
696570|NCT01376557|Secondary|Change From Baseline in Triglycerides at Week 12||12 weeks|ITT||mg/dL||Standard Deviation|Mean
696571|NCT01376557|Secondary|Change From Baseline in Systolic Blood Pressure (SPB) at Week 12||12 weeks|ITT||mm Hg||Standard Deviation|Mean
696572|NCT01376557|Secondary|Change From Baseline in Body Weight at Week 12||12 weeks|ITT||kg||Standard Deviation|Mean
696573|NCT01376557|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12||12 weeks|ITT||mg/dL||Standard Deviation|Mean
696574|NCT01376557|Secondary|Number of Participants Achieving a HbA1c Value of <7% at Week 12||12 weeks|ITT||participants|||Number
696575|NCT01376557|Primary|Change From Baseline in HbA1c to Week 12||12 weeks|ITT||% change||Standard Deviation|Mean
696576|NCT01376388|Secondary|Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings at the Indicated Time Points|A 12-lead ECG was recorded in a supine position after the participant was kept at rest in this position for at least 5 minutes. Data are presented as clinically significant (CS) or not clinically significant (NCS) abnormal findings. An abnormal and significant ECG finding includes the presence of a QT interval corrected for heart rate (QTc interval) >500 milliseconds (msec) or an uncorrected QT interval >600 msec, for participants with Bundle Branch Block QTc >530 msec based on an average QTc value of triplicate ECGs. The study investigator determined if the abnormal ECG finding was CS or NCS. The WD visit was conducted for participants who withdrew at any point during the study. The Week 24/WD and Week 52/WD visits were conducted for participants who completed the Week 24 visit or withdrew before Week 24 and completed the Week 52 visit or withdrew before Week 52, respectively. The Baseline value for clinical laboratory tests was the value recorded on Week -2 (Screening visit).|Baseline (Screening visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD|"ITT Population. Only those participants remaining in the study and contributing evaluable data at the indicated time points were analyzed. The number of participants assessed at each time point is indicated by n=X in the category title."||Participants|||Number
696577|NCT01376388|Secondary|Change From Baseline in Heart Rate|Heart rate was measured in a sitting position after the participant was kept at rest for at least 5 minutes. Change from Baseline was calculated as the assessment value at the time of interest minus the Baseline value. The WD visit was conducted for participants who withdrew at any point during the study. The Week 24/WD visit was conducted for participants who completed the Week 24 visit or withdrew before Week 24. The Week 52/WD visit was conducted for participants who completed the Week 52 visit or withdrew before Week 52.|Baseline (Week 0), Week 4, Week 8, Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD|"ITT Population. Only those participants with post-Baseline data available at the indicated time points were analyzed (represented by n=X in the category title). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population."||Beats per minute||Standard Deviation|Mean
696578|NCT01376388|Secondary|Change From Baseline in Blood Pressure|Blood pressure measurements included systolic blood pressure (SBP) and diastolic blood pressure (DBP). Blood pressure was measured in a sitting position after the participant was kept at rest for at least 5 minutes. Change from Baseline was calculated as the assessment value at the time of interest minus the Baseline value. The WD visit was conducted for participants who withdrew at any point during the study. The Week 24/WD visit was conducted for participants who completed the Week 24 visit or withdrew before Week 24. The Week 52/WD visit was conducted for participants who completed the Week 52 visit or withdrew before Week 52.|Baseline (Week 0), Week 4, Week 8, Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD|"ITT Population. Only those participants with post-Baseline data available at the indicated time points were analyzed (represented by n=X in the category title). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population."||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
696579|NCT01376388|Secondary|Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD|Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 visit or withdrew before Week 52). The Baseline value for clinical laboratory tests was the value recorded on Week -2 (Screening visit).|BL (Screening visit: Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD|"ITT Population. Only those participants remaining in the study and contributing evaluable data at the indicated time points were analyzed. The number of participants assessed for each parameter is indicated by n=X in the category title."||Millimoles/Liter (MMOL/L)||Standard Deviation|Mean
696580|NCT01376388|Secondary|Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD|Blood samples were collected for the measuremnt of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 visit or withdrew before Week 52). The Baseline value for clinical laboratory tests was the value recorded on Week -2 (Screening visit).|BL (Screening visit: Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD|"ITT Population. Only those participants remaining in the study and contributing evaluable data at the indicated time points were analyzed. The number of participants assessed for each parameter is indicated by n=X in the category title."||Micromoles/Liter (µM/L)||Standard Deviation|Mean
696581|NCT01376388|Secondary|Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD|Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 visit or withdrew before Week 52). The Baseline value for clinical laboratory tests was the value recorded on Week -2 (Screening visit).|BL (Screening visit: Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD|"ITT Population. Only those participants remaining in the study and contributing evaluable data at the indicated time points were analyzed. The number of participants assessed for each parameter is indicated by n=X in the category title."||International Units/Liter (IU/L)||Standard Deviation|Mean
696582|NCT01376388|Secondary|Hematocrit Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD|Blood samples were collected for the measurement of hematocrit at the following time points: BL (Week -2), Week 12, Week 24, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 visit or withdrew before Week 52). The Baseline value for clinical laboratory tests was the value recorded on Week -2 (Screening visit).|BL (Screening visit: Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD|"ITT Population. Only those participants remaining in the study and contributing evaluable data at the indicated time points were analyzed. The number of participants assessed at each time point is indicated by n=X in the category title."||Proportion||Standard Deviation|Mean
696583|NCT01376388|Secondary|Hemoglobin, Albumin, and Total Protein Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/Withdrawal (WD)|Blood samples were collected for the measurement of hemoglobin, albumin, and total protein at the following time points: BL (Week -2), Week 12, Week 24, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 visit or withdrew before Week 52). The Baseline value for clinical laboratory tests was the value recorded on Week -2 (Screening visit).|BL (Screening visit: Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD|"ITT Population. Only those participants remaining in the study and contributing evaluable data at the indicated time points were analyzed. The number of participants assessed for each parameter is indicated by n=X in the category title."||Grams/Liter (G/L)||Standard Deviation|Mean
696584|NCT01376388|Secondary|Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD|Blood samples were collected for the measurment of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 visit or withdrew before Week 52). The Baseline value for clinical laboratory tests was the value recorded on Week -2 (Screening visit).|BL (Screening visit: Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD|ITT Population. Only those participants remaining in the study and contributing evaluable data at the indicated time points were analyzed. The number of participants assessed for each parameter is indicated by ''n=X'' in the category title.||10^9 cells/Liter (GI/L)||Standard Deviation|Mean
696585|NCT01376388|Secondary|Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD|Blood samples were collected for the measurement of the indicated laboratory parameters at following time points: BL (Week -2), Week 12, Week 24, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 visit or withdrew before Week 52). The Baseline value for clinical laboratory tests was the value recorded on Week -2 (Screening visit).|BL (Screening visit: Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD|"ITT Population. Only those participants remaining in the study and contributing evaluable data at the indicated time points were analyzed. The number of participants assessed for each parameter is indicated by ''n=X in the category title."||Percentage of cells in blood||Standard Deviation|Mean
696586|NCT01376388|Primary|Number of Participants With AEs Classified by the Indicated Maximum Grade Throughout the Treatment Period|An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. AEs were classified according to intensity based upon the investigators' clinical judgment. The intensity was categorized as: mild (an event that is easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities); moderate (an event that is sufficiently discomforting to interfere with normal everyday activities); or severe (an event that prevents normal everyday activities).|52 weeks|ITT Population||Participants|||Number
696587|NCT01376388|Primary|Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Treatment Period|An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs (occuring at a frequency threshold of >=5%) and SAEs.|52 weeks|Intent-to-Treat (ITT) Population: all participants who had received at least one dose of study drug||Participants|||Number
696588|NCT01376362|Secondary|Proportion of Participants With a Visual Loss of 15 or More Early Treatment Diabetic Retinopathy Study (ETDRS) Letters in the Study Eye|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 2 Weeks|||Percentage of Participants|||Number
696589|NCT01376362|Secondary|Change in Intraocular Pressure (IOP) in the Fellow Eye at Week Two Compared to Baseline|Intraocular pressure was recorded using a standard Goldmann applanation tonometer, a device for the measurement of intraocular pressure between 0 to 78 mm Hg.|Baseline and 2 Weeks|||mm Hg||Standard Deviation|Mean
696590|NCT01376362|Secondary|Change in Intraocular Pressure (IOP) in the Study Eye at Week Two Compared to Baseline|Intraocular pressure was recorded using a standard Goldmann applanation tonometer, a device for the measurement of intraocular pressure between 0 to 78 mm Hg.|Baseline and 2 Weeks|||mm Hg||Standard Deviation|Mean
696591|NCT01376362|Secondary|Change in Intraocular Pressure (IOP) in the Fellow Eye at Week One Compared to Baseline|Intraocular pressure was recorded using a standard Goldmann applanation tonometer, a device for the measurement of intraocular pressure between 0 to 78 mm Hg.|Baseline and 1 Week|||mm Hg||Standard Deviation|Mean
696592|NCT01376362|Secondary|Change in Intraocular Pressure (IOP) in the Study Eye at Week One Compared to Baseline|Intraocular pressure was recorded using a standard Goldmann applanation tonometer, a device for the measurement of intraocular pressure between 0 to 78 mm Hg.|Baseline and 1 Week|||mm Hg||Standard Deviation|Mean
696593|NCT01376362|Secondary|Change in ETDRS Best-corrected Visual Acuity (BCVA) in the Fellow Eye at Week Two Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 2 Weeks|||ETDRS Letters||Standard Deviation|Mean
696594|NCT01376362|Secondary|Change in ETDRS Best-corrected Visual Acuity (BCVA) in the Study Eye at Week Two Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 2 Weeks|||ETDRS Letters||Standard Deviation|Mean
696595|NCT01376362|Secondary|Change in ETDRS Best-corrected Visual Acuity (BCVA) in the Fellow Eye at Week One Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 1 Week|||ETDRS Letters||Standard Deviation|Mean
696596|NCT01376362|Secondary|Change in ETDRS Best-corrected Visual Acuity (BCVA) in the Study Eye at Week One Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 1 Week|||ETDRS Letters||Standard Deviation|Mean
696597|NCT01376362|Secondary|Change in Macular Volume in the Fellow Eye, as Measured by Optical Coherence Tomography (OCT), at Week Two Compared to Baseline|Macular volume was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|Baseline and 2 Weeks|||mm^3||Standard Deviation|Mean
696598|NCT01376362|Secondary|Change in Macular Volume in the Study Eye, as Measured by Optical Coherence Tomography (OCT), at Week Two Compared to Baseline|Macular volume was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|Baseline and 2 Weeks|||mm^3||Standard Deviation|Mean
696599|NCT01376362|Secondary|Change in Macular Volume in the Fellow Eye, as Measured by Optical Coherence Tomography (OCT), at Week One Compared to Baseline|Macular volume was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|Baseline and 1 Week|||mm^3||Standard Deviation|Mean
696600|NCT01376362|Secondary|Change in Macular Volume in the Study Eye, as Measured by Optical Coherence Tomography (OCT), at Week One Compared to Baseline|Macular volume was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|Baseline and 1 Week|||mm^3||Standard Deviation|Mean
696601|NCT01376362|Secondary|Change in Excess Central Macular Thickening in the Fellow Eye, as Measured by Optical Coherence Tomography (OCT), at Week Two Compared to Baseline|Central macular thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|Baseline and 2 Weeks|||µm||Standard Deviation|Mean
696604|NCT01376362|Primary|Change in Excess Central Macular Thickening in the Study Eye, as Measured by Optical Coherence Tomography (OCT), at Week One Compared to Baseline|Central macular thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|Baseline and 1 Week|||µm||Standard Deviation|Mean
696605|NCT01376349|Primary|Alleviation of the Most Bothersome Vaginal Symptom (Vaginal Dryness or Dyspareunia) Over 12 Weeks|"The primary outcome is severity of the most bothersome vaginal symptom: dryness or dyspareunia. The Vaginal Symptom Measure (VSM) was used to evaluate the severity of vaginal dryness and dyspareunia. The VSM uses a 5- point ordinal response scale; 1=none, 2=mild, 3=moderate, 4=severe and 5=very severe to measure the severity associated with vaginal dryness and/or dyspareunia. For each patient, the change in severity was calculated by subtracting the baseline from the week 12 reported score. Therefore, the full range of scores ranges from -4 (greatest decrease in severity) to 4 (greatest increase in severity). A negative score indicates a decrease in severity from baseline, zero indicates no reported affect and positive scores indicate a more severe report at week 12. The primary assessment method will be a comparison of the averages of the changes over time in the severity items for the most bothersome symptom from baseline to 12 weeks (as indicated at baseline)."|At baseline and 12 weeks|All patients that started treatment and completed their week 12 evaluation are included in this analysis.||change in units on a scale||Full Range|Median
696606|NCT01376297|Primary|Percentage of Patients With Adverse Events|This was a safety study where Adverse Events is the primary outcome (defined by the current ICH Guideline for Good Clinical Practice). Patients were randomized according to a 3:1 ratio (netupitant/palonosetron:aprepitant/palonosetron). No formal comparison was planned, the presence of a control in the same patient population helped interpret any unexpected safety finding in the experimental arm.The number of patients was estimated in order to have more than 100 patients treated with the netupitant/palonosetron comination for up to at least six cycles. Based on 100 patients, if a given AE is not observed, an AE incidence of 3% or greater can be excluded with 95% confidence.|Participants will be followed for the duration of the chemotherapy, an expected average duration of up to 24 weeks assuming 6 chemotherapy cycles given every 4 weeks|Safety Population||percentage of patients with TEAE|||Number
696607|NCT01376245|Secondary|Mean Change From Baseline in Chronic Respiratory Disease Questionnaire Self-administered Standardized (CRQ-SAS) Dyspnea Domain Score at Day 168|CRQ-SAS measures 4 domains (fatigue, emotional function, mastery and dyspnea) of functioning of participants (par.) with COPD: mastery (amount of control the par. feels he/she has over COPD symptoms); fatigue (how tired the par. feels); emotional function (how anxious/depressed the par. feels); and dyspnea (how short of breath the par. feels during physical activities). Each domain is calculated separately and measured on a scale of 1-7 (1=maximum impairment; 7=no impairment). Dyspnea domain score is the mean of all non-missing responses for that domain. Only the dyspnea domain was measured as a secondary outcome. BL scores are the derived scores for each domain and total at Day 1 pre-dose. Change from BL was calculated as the average of the Day 168 values minus the BL value. Analysis performed used a repeated measures model with covariates of treatment, smoking status at screening (stratum), BL (derived scores at Day 1 pre-dose), day, day by BL, and day by treatment interactions.|Baseline (BL) and Day 168|ITT Population. Only those participants available at the indicated time point were assessed.||Scores on a scale||Standard Error|Least Squares Mean
696608|NCT01376245|Primary|Mean Change From Baseline in Clinic Visit Pre-dose Trough FEV1 at Day 169|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 was defined as the pre-dose and pre-bronchodilator FEV1, which was obtained at each clinic visit. Baseline is defined as the mean of the two assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1.Trough FEV1 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing at each clinic visit. Change from Baseline was calculated as the average at each clinic visit minus the Baseline value. Analysis was performed using a repeated measures model with covariates of treatment, smoking status at screening (stratum), baseline - mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1, day, day by baseline and day by treatment interactions.|Baseline to Day 169|Intent-to-Treat (ITT) Population: all randomized par. who received at least one dose of study medication. Number of par. presented represents those with data available at the time point being presented, however, all par. in the ITT population without missing covariate information with at least one post BL measurement are included in the analysis.||Liters||Standard Error|Least Squares Mean
696609|NCT01376089|Secondary|Comparison of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis.|Overall Image Quality rated as ‘Excellent, Adequate or Poor’ by radiologists blinded to the contrast administration.|Ten minutes post contrast administration.|||Number of subject images|||Number
696610|NCT01376089|Primary|Frequency of Subjects With Moderate / Severe Discomfort When Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis.|Number of subjects experiencing moderate (score of 4 -7) to severe (score of 8 - 10) discomfort for cold, heat or pain between Iodixanol and Iopamidol.|Within 10 minutes post contrast administration.|||Number of Subjects with discomfort|||Number
696611|NCT01376089|Primary|Frequency of Subjects With Moderate/Severe Discomfort When Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis.|Number of subjects experiencing any moderate (score of 4 - 7) to severe (score 8 - 10) discomfort for cold or heat or pain between Iodixanol and Iopamidol.|Within 10 minutes post contrast administration|||Number of Subjects with discomfort|||Number
696612|NCT01376050|Secondary|Change in Ulcer Size|The study ulcer was digitally photographed, and the ulcer size/area calculated in centimeters squared (cm²) using the Aranz Medical SilhouetteMobile™ System, a portable handheld computer device with custom camera and software that enables capturing of a wound image at the point of care. The change in ulcer size from baseline to study endpoint (12 weeks) was calculated. A decrease in ulcer size indicates an improvement in the ulcer status and is positive for study success. An increase in ulcer size indicates a worsening of the ulcer status and is negative for study success.|Baseline and 12 Weeks|||cm²||Standard Deviation|Mean
697279|NCT01368536|Secondary|Percentage of Patients Achieving Blood Pressure Control After Treatment|Patient with blood pressure control is defined as patients achieving MSSBP <130 mmHg and MSDBP <80 mmHg.|12 weeks|The study was terminated and consequentially was underpowered for adequate statistical analysis|||||
696613|NCT01376050|Primary|Difference in the Proportion of Venous Stasis Ulcers Attaining Complete Wound Closure Between Treatment Groups|'Complete wound closure' is defined as skin re-epithelialization without drainage or dressing requirements confirmed across a consecutive two-week evaluation period. Efficacy success was defined as a statistically significant greater proportion of venous stasis ulcers in the test procedure group achieving complete wound closure compared with the proportion of venous stasis ulcers in the placebo procedure group achieving complete wound closure.|Baseline and 12 Weeks|||participants|||Number
696614|NCT01376037|Primary|Change in Combined Upper Arm Circumference Measurements From Baseline to Endpoint|Change in combined upper arm circumference measurements is calculated as the difference in combined upper arm circumference measurements from baseline to endpoint (2 weeks) for each of the right upper arm and the left upper arm, separately. A change of at least +1.25 centimeters, for each of the right upper arm and the left upper arm, separately, is considered positive for study success for an individual subject. It was pre-determined that the overall study would be considered a success if at least 50% (16 or more out of 31) of the test group subjects attained individual subject success and individual subject successes in the placebo group were at least 35% lower than for test group subjects (5 or less out of 31).|baseline and 2 weeks|||participants|||Number
696615|NCT01375777|Secondary|Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12||Baseline and Week 12|Full analysis set; missing data at Week 12 were imputed using LOCF.||percent change||Standard Error|Least Squares Mean
696616|NCT01375777|Secondary|Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12||Baseline and Week 12|Full analysis set; missing data at Week 12 were imputed using LOCF.||percent change||Standard Error|Least Squares Mean
696617|NCT01375777|Secondary|Percent Change From Baseline in Apolipoprotein B at Week 12||Baseline and Week 12|Full analysis set; missing data at Week 12 were imputed using LOCF.||percent change||Standard Error|Least Squares Mean
696618|NCT01375777|Secondary|Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12||Baseline and Week 12|Full analysis set; missing data at Week 12 were imputed using LOCF.||percent change||Standard Error|Least Squares Mean
696619|NCT01375777|Secondary|Change From Baseline in LDL-C at Week 12|LDL-C was measured using ultracentrifugation.|Baseline and Week 12|Full analysis set; missing ultracentrifugation (UC) LDL-C at Week 12 was imputed using LOCF.||mg/dL||Standard Error|Least Squares Mean
696620|NCT01375777|Primary|Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12|LDL-C was measured using ultracentrifugation.|Baseline and Week 12|Full analysis set; missing ultracentrifugation (UC) LDL-C at Week 12 was imputed using last observation carried forward (LOCF) and calculated LDL-C.||percent change||Standard Error|Least Squares Mean
696621|NCT01375764|Secondary|Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe|LS means are based off an ANCOVA model which includes treatment group (evoloumab + ezetimibe and ezetimibe alone) and stratification factors as covariates.|Baseline and Week 12|Full analysis set; missing data at Week 12 were imputed using LOCF.||percent change||Standard Error|Least Squares Mean
696622|NCT01375764|Secondary|Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12|LS means are based off an ANCOVA model which includes treatment group (3 evolocumab alone dose groups and the ezetimibe group) and stratification factors as covariates.|Baseline and Week 12|Full analysis set; missing data at Week 12 were imputed using LOCF.||percent change||Standard Error|Least Squares Mean
696623|NCT01375764|Secondary|Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe|LS means are based off an ANCOVA model which includes treatment group (evoloumab + ezetimibe and ezetimibe alone) and stratification factors as covariates.|Baseline and Week 12|Full analysis set; missing data at Week 12 were imputed using LOCF.||percent change||Standard Error|Least Squares Mean
696624|NCT01375764|Secondary|Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12|LS means are based off an ANCOVA model which includes treatment group (3 evolocumab alone dose groups and the ezetimibe group) and stratification factors as covariates.|Baseline and Week 12|Full analysis set; missing data at Week 12 were imputed using LOCF.||percent change||Standard Error|Least Squares Mean
696625|NCT01375764|Secondary|Percent Change From Baseline in Apolipoprotein B at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe|LS means are based off an ANCOVA model which includes treatment group (evoloumab + ezetimibe and ezetimibe) and stratification factors as covariates.|Baseline and Week 12|Full analysis set; missing Apolipoprotein B at Week 12 was imputed using LOCF.||percent change||Standard Error|Least Squares Mean
696626|NCT01375764|Secondary|Percent Change From Baseline in Apolipoprotein B at Week 12|LS means are based off an ANCOVA model which includes treatment group (3 evolocumab alone dose groups and the ezetimibe group) and stratification factors as covariates.|Baseline and Week 12|Full analysis set; missing Apolipoprotein B at Week 12 was imputed using LOCF.||percent change||Standard Error|Least Squares Mean
696627|NCT01375764|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe|LS means are based off an ANCOVA model which includes treatment group (evolocumab + ezetimibe and ezetimibe alone) and stratification factors as covariates.|Baseline and Week 12|Full analysis set; missing non-HDL-C at Week 12 was imputed using LOCF.||percent change||Standard Error|Least Squares Mean
696628|NCT01375764|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12|LS means are based off an ANCOVA model which includes treatment group (3 evolocumab alone dose groups and the ezetimibe group) and stratification factors as covariates.|Baseline and Week 12|Full analysis set; missing non-HDL-C at Week 12 was imputed using LOCF.||percent change||Standard Error|Least Squares Mean
696629|NCT01375764|Secondary|Change From Baseline in LDL-C at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe|LDL-C was measured using ultracentrifugation. LS means are based off an ANCOVA model which includes treatment group (evoloumab + ezetimibe and ezetimibe alone) and stratification factors as covariates.|Baseline and Week 12|Full analysis set; Missing UC LDL-C at Week 12 was imputed using LOCF.||mg/dL||Standard Error|Least Squares Mean
696630|NCT01375764|Secondary|Change From Baseline in LDL-C at Week 12|LDL-C was measured using ultracentrifugation. LS means are based off an ANCOVA model which includes treatment group (3 evolocumab alone dose groups and the ezetimibe group) and stratification factors as covariates.|Baseline and Week 12|Full analysis set; Missing UC LDL-C at Week 12 was imputed using LOCF.||mg/dL||Standard Error|Least Squares Mean
696631|NCT01375764|Primary|Percent Change From Baseline in LDL-C at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe|LDL-C was measured using ultracentrifugation. LS means are based off an ANCOVA model which includes treatment group (evolocumab + ezetimibe and ezetimibe alone) and stratification factors as covariates.|Baseline and Week 12|Full analysis set; Missing UC LDL-C at Week 12 was imputed using LOCF and calculated LDL-C.||percent change||Standard Error|Least Squares Mean
696632|NCT01375764|Primary|Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12|LDL-C was measured using ultracentrifugation. Least squares (LS) means are based off an analysis of covariance (ANCOVA) model which includes treatment group (3 evolocumab alone dose groups and the ezetimibe group) and stratification factors as covariates.|Baseline and Week 12|Full analysis set; Missing ultracentrifugation (UC) LDL-C at Week 12 was imputed using last observation carried forward (LOCF) and calculated LDL-C.||percent change||Standard Error|Least Squares Mean
696633|NCT01375751|Secondary|Percent Change From Baseline in Apolipoprotein B /Apolipoprotein A-1 Ratio at Week 12||Baseline and Week 12|Full analysis set; LOCF imputation was used.||percent change||Standard Error|Least Squares Mean
696634|NCT01375751|Secondary|Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12||Baseline and Week 12|Full analysis set; LOCF imputaton was used.||percent change||Standard Error|Least Squares Mean
696635|NCT01375751|Secondary|Percent Change From Baseline in Apolipoprotein B at Week 12||Baseline and Week 12|Full analysis set; LOCF imputation was used||percent change||Standard Error|Least Squares Mean
696636|NCT01375751|Secondary|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (HDL-C) at Week 12||Baseline and Week 12|Full analysis set; LOCF imputation was used.||percent change||Standard Error|Least Squares Mean
696637|NCT01375751|Secondary|Absolute Change From Baseline in LDL-C at Week 12|LDL-C was measured using ultracentrifugation.|Baseline and Week 12|Full analysis set; LOCF imputation was used.||mg/dL||Standard Error|Least Squares Mean
696638|NCT01375751|Primary|Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12|LDL-C was measured using ultracentrifugation.|Baseline and Week 12|Full analysis set; Missing ultracentrifugation (UC) LDL-C data at Week 12 were imputed using last observation carried forward (LOCF) and calculated LDL-C.||percent change||Standard Error|Least Squares Mean
696639|NCT01375660|Secondary|Incident Diabetes||12 Months|||participants|||Number
696640|NCT01375660|Post-Hoc|Change in Glycemia||12 Months|||percentage of participants|||Number
696641|NCT01375660|Secondary|C-Peptidogenic Index-30|"Index of insulin secretion, higher index means higher insulin secretion. C-peptide circulates in blood in amounts equal to insulin because insulin and C-peptide are linked when first made by the pancreas. C-peptide is more stable in blood than insulin; therefore it can be reliably used to evaluate insulin secretion. It is calculated by a special formula using C-peptide and glucose measured at 0 min and at 30 min (hence 30 in the name) in Oral Glucose Tolerance test.
Insulin secretion was assessed based on formula C-Peptidogenic index-30 [(C-Peptide at 30 min – fasting C-peptide)/(glucose at 30 min – fasting glucose)]Bergstrom RW, Wahl PW, Leonetti DL, Fujimoto WY. Association of fasting glucose levels with a delayed secretion of insulin after oral glucose in subjects with glucose intolerance. J Clin Endocrinol Metab. 1990;71:1447-1453.)"|12 Month|||(ng/mL)/(mg/dL)||Standard Deviation|Mean
696642|NCT01375660|Secondary|Insulinogenic Index-30|"Index of insulin secretion, higher index means higher insulin secretion. It is calculated by a special formula using insulin and glucose measured at 0 min and at 30 min (hence 30 in the name) in Oral Glucose Tolerance test.
Insulin secretion was assessed based on formula Insulinogenic index-30 [(insulin at 30 min - fasting insulin)/(glucose at 30 min - fasting glucose)] (Kosaka K, Hagura R, Kuzuya T. Insulin responses in equivocal and definite diabetes, with special reference to subjects who had mild glucose intolerance but later developed definite diabetes. Diabetes. 1977;26:944-952)"|12 Month|||(µU/mL)/(mg/dL)||Standard Deviation|Mean
696643|NCT01375660|Secondary|Insulin Sensitivity by Matsuda Composite|"Insulin Sensitivity by Matsuda Composite – index of insulin sensitivity, higher index means higher insulin sensitivity. Low insulin sensitivity means high insulin resistance and high risk of type 2 diabetes mellitus. It is calculated by a special formula using insulin and glucose measured in Oral Glucose Tolerance test. The formula is different from a formula for OGIS.
Matsuda composite calculated based on formula 10^4/Square Root of [(fasting glucose x fasting insulin) x (mean glucose x mean insulin)] (Matsuda M, DeFronzo RA. Insulin sensitivity indices obtained from oral glucose tolerance testing: comparison with the euglycemic glucose clamp. Diabetes Care. 1999;22:1462-1470) Unit of measure is 10000/√[(µU/mL)/(mg/dL)]x[(µU/mL)/(mg/dL)]."|12 Months|||10^4/√[(µU/mL)/(mg/dL)x(µU/mL)/(mg/dL)]||Standard Deviation|Mean
696644|NCT01375660|Secondary|Change in HbA1c From Baseline at 12 Months||Baseline and 12 Months|||percentage of A1C||Standard Deviation|Mean
696645|NCT01375660|Primary|Oral Glucose Insulin Sensitivity (OGIS)|"Oral glucose insulin sensitivity = index of insulin sensitivity, higher index means higher insulin sensitivity. Low insulin sensitivity means high insulin resistance and high risk of type 2 diabetes mellitus. It is calculated by a special formula using insulin and glucose measured in Oral Glucose Tolerance test.
The primary outcome was the change in oral glucose insulin sensitivity (OGIS, from oral glucose tolerance test) after 12 months of treatment calculated as OGIS at 12-months minus OGIS baseline."|12 months|||ml/min/m^2 of body surface area||Standard Deviation|Mean
696646|NCT01375608|Primary|The Percentage Change in HbF Level From Baseline to the Average Over the Final 1 Month of Study.||Final 1 month of study|||Participants|||Count of Participants
696647|NCT01375569|Secondary|Count of Participants With Adverse Events|here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|25 months, 15 days|||Participants|||Count of Participants
696648|NCT01375569|Primary|Time to Tumor Progression (TTP) for TRC105 in Hepatocellular Carcinoma (HCC).|Time to tumor progression is defined as the proportion of participants who are progression free after 4 months on study. Progression is defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Progression is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. (Note: the appearance of one or more new lesions is also considered progressions).|2 years|||Weeks||Full Range|Mean
703395|NCT00094900|Secondary|Mean Change in WBCs|White Blood Cell count change from baseline to 24 months|24 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||x 10^3 cells/microliter||Standard Error|Mean
696653|NCT01375127|Primary|Number of Participants Who Died||Baseline through Month 12|Safety analysis included all eligible participants who had provided an informed consent for this study.||participants|||Number
696654|NCT01375127|Primary|Number of Participants With Graft Failure|Graft failure which occurred within 12 months after the last dose of tofacitinib was reported. Graft failure was defined as graft nephrectomy, re-transplantation, or return to dialysis for greater than or equal to (>=) 6 consecutive weeks.|Baseline through Month 12|Safety analysis included all eligible participants who had provided an informed consent for this study.||participants|||Number
696655|NCT01375127|Primary|Number of Participants With Central Nervous System (CNS) Infection|Participants with CNS infection involving the brain or spinal cord, within 12 months after the last dose of tofacitinib were reported.|Baseline through Month 12|Safety analysis included all eligible participants who had provided an informed consent for this study.||participants|||Number
696656|NCT01375127|Primary|Number of Participants With Clinical Outcome of Post Transplant Lymphoproliferative Disease (PTLD)|All lymphoproliferative disorders diagnosed locally as PTLD based on histopathology were reported.|Baseline through Month 12|Safety analysis included all eligible participants who had provided an informed consent for this study.||participants|||Number
696657|NCT01375049|Primary|Percentage of Participants With PA-negative Cultures at All Time Points After Cessation of Active Treatment (Sensitivity Analysis Set)|The percentage of participants with PA-negative cultures at all time points after cessation of active treatment at Day 28 (assessed at Days 56, 112, and 196) was summarized for the Sensitivity Analysis Set.|Day 28 to Day 196|Sensitivity Analysis Set||percentage of participants||95% Confidence Interval|Number
696658|NCT01375049|Secondary|Pharmacokinetics (PK) Peak and Trough Plasma Concentrations of Aztreonam|The plasma concentration of aztreonam for participants < 6 years of age was obtained 1 hour after the first dose of AZLI on Day 1 and immediately prior to the last dose of AZLI on Day 28.|Day 1 (1 hour postdose) and Day 28 (immediately prior to dosing)|Participants in the Full Analysis Set < 6 years of age with evaluable PK profiles were analyzed.||ng/mL||Standard Deviation|Mean
696659|NCT01375049|Secondary|Change From Baseline in Body Mass Index (BMI)||Baseline to Days 28, 56, 112, and 196|Full Analysis Set||kg/m^2||Standard Deviation|Mean
696660|NCT01375049|Secondary|Change From Baseline in Height||Baseline to Days 28, 56, 112, and 196|Full Analysis Set||cm||Standard Deviation|Mean
696661|NCT01375049|Secondary|Change From Baseline in Weight||Baseline to Days 28, 56, 112, and 196|Full Analysis Set||kg||Standard Deviation|Mean
696662|NCT01375049|Secondary|Use of Additional (Non-study) Antipseudomonal Antibiotics|The percentage of participants who used additional (non-study) antipseudomonal antibiotics (an indication of PA exacerbation) while on treatment and posttreatment was summarized.|Baseline to Day 196|Full Analysis Set||percentage of participants|||Number
696663|NCT01375049|Secondary|Percentage of Participants With PA-negative Cultures|The percentage of participants with a PA-negative culture was summarized at each visit.|Days 28, 56, 112, and 196|Participants from the Full Analysis Set who completed study drug and did not receive an additional antipseudomonal antibiotic during the 28-day AZLI treatment course were included in the analysis at all time points.||percentage of participants|||Number
696664|NCT01375049|Secondary|Change From Baseline in CFQ-R RSS Score|Respiratory symptoms (eg, coughing, congestion, wheezing) were assessed with the Cystic Fibrosis Questionnaire – Revised (CFQ-R) Respiratory Symptoms Scale (RSS) only in participants ≥ 6 years of age. The range of scores (units) is 0 to 100 with higher scores indicating fewer symptoms.|Baseline to Days 28, 56, 112, and 196|Participants in the Sensitivity Analysis Set ≥ 6 years of age with available data for this assessment were analyzed.||units on a scale||Standard Deviation|Mean
696665|NCT01375049|Secondary|Change From Baseline in FEV1% Predicted|Spirometry assessments were performed only in participants ≥ 6 years of age. Forced expiratory volume in 1 second (FEV1) % predicted was defined as FEV1 of the participant divided by the average FEV1 in the population for any person of similar age, sex and body composition.|Baseline to Days 28, 56, 112, and 196|Participants in the Sensitivity Analysis Set ≥ 6 years of age with available data for this assessment were analyzed.||percentage of FEV1% predicted||Standard Deviation|Mean
697280|NCT01368536|Secondary|Percentage of Responders After Treatment|Responders are defined as patients with MSSBP <130 mmHg or a decrease from baseline in MSSBP of ≥20 mmHg|Baseline, 12 weeks|The study was terminated and consequentially was underpowered for adequate statistical analysis|||||
696666|NCT01375049|Primary|Percentage of Participants With PA-negative Cultures at All Time Points After Cessation of Active Treatment (Evaluable Analysis Set)|The percentage of participants with PA-negative cultures at all time points after cessation of active treatment at Day 28 (assessed at Days 56, 112, and 196) was summarized for the Evaluable Analysis Set.|Day 28 to Day 196|Evaluable Analysis Set||percentage of participants||95% Confidence Interval|Number
696667|NCT01374971|Secondary|Percent Change From Screening in Disease Activity Score (DAS) 28 ESR After 14 Weeks of Treatment|The DAS 28 ESR is a score calculated from the results of a 28-count joint assessment (total number of tender joint possible is 28, and total number of swollen joints possible is 28), the Erythrocyte Sedimentation Rate (ESR), and the Patient Global Assessment (measured using a 100 mm visual analogue scale, with the lowest possible score of 0 mm meaning the subject is not affected at all by arthritis and the highest possible score of 100 mm meaning the subject is severely affected by arthritis). A lower DAS 28 ESR indicates less active disease, and a higher DAS 28 ESR indicates more active disease. The DAS 28 ESR was calculated for each subject at the screening visit and at the Week 14 final visit. The percent change was then calculated for each patient, and a mean percent change for all subjects was determined.|Screening and Week 14|||percent change||Standard Deviation|Mean
696668|NCT01374971|Primary|Percent Change From Baseline in Synovial TNFa, CXCL13, IL-8, IL-6, IL-1b, IL-10, IP-10, BCL3, CD3E, DUSP4, FOXP3, CD79A, CD138, MMP-3, and MMP-1 After 12 Weeks of Treatment With Certolizumab Pegol (CZP) in Patients With Rheumatoid Arthritis|Synovial tissue biopsy samples were taken at baseline and at 12 weeks after starting treatment with CZP. These samples were analyzed to determine the concentrations of select biomarkers and to determine the percent change in concentration from baseline to week 12.|Baseline and Week 12|||Percent change||95% Confidence Interval|Geometric Mean
696669|NCT01374919|Secondary|Number of Participants With Treatment Related Serious Adverse Events. Calls for Minor Side Effects Will Occur at 24 and 48 Hours and One Week. A Followup Visit Will Occur at 4 Weeks.||immediate, 24 and 48 hours, one week and followup visit at 4 weeks|||participants|||Number
696670|NCT01374919|Primary|Efficacy of 1020 mg of Ferumoxytol Over 15 Minutes. Hemoglobin Measurements Will Take Place at Four and Eight Week Visit.|Percentage of participates with indicated increase in hemoglobin from baseline to week 4 and week 8|baseline 4 weeks and 8 weeks|Two patients had minor infusion reactions and refused rechallenge. All other patients completed the study. Their hemoglobin levels, the primary outcome, were obtained at 4 and 8 weeks.||percentage of participants|||Number
696671|NCT01374802|Secondary|Tmax,ss of Darunavir|time from last dosing to maximum concentration of the analyte in plasma at steady state|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00,12:00 hours (h) after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r)|PK set||h||Full Range|Median
696672|NCT01374802|Primary|Cmax,ss of Darunavir|maximum measured concentration of the analyte in plasma at steady-state|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00,12:00 h after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r)|PK set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
696673|NCT01374802|Primary|Cτ,ss of Darunavir|concentration of the analyte in plasma at steady-state after a uniform dosing interval τ=24h of darunavir|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00,12:00 h after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r)|PK set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
696674|NCT01374802|Primary|AUCτ,ss of Darunavir|"area under the concentration-time curve of the analyte in plasma at steadystate over a uniform dosing interval τ of darunavir.
The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities"|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00,12:00 hours (h) after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r)|Pharmacokinetic (PK) set: all subjects in the treated set who provided at least one observation for at least one primary endpoint without any important protocol violations relevant to the pharmacokinetic evaluation and who did not experience vomiting at or before 2 times median tmax.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
696675|NCT01374568|Primary|Bone Turnover in Subjects Treated With Sitagliptin When Compared to Those Treated With Placebo|Bone turnover assessed using change in bone-specific alkaline phosphatase (BAP) over 8 weeks of treatment.|8 WEEKS|The difference between the bone turnover markers bone alkaline phosphatase (BAP) from baseline to end of study were calculated for treatment and placebo groups. Serum samples were not available for one placebo participant at baseline and for one placebo patient at end of study.||mg/L||Standard Deviation|Mean
696676|NCT01374568|Primary|Bone Turnover in Subjects Treated With Sitagliptin When Compared to Those Treated With Placebo.|Bone turnover assessed using change in TRACP5b over 8 weeks of treatment.|8 weeks|The difference between the bone turnover markers TRACP5b from baseline to end of study were calculated for treatment and placebo groups. Serum samples were not available for one placebo participant at baseline and for one placebo patient at end of study. As a result we were unable to analyze the 2 participants with missing data.||U/L||Standard Deviation|Mean
696677|NCT01374451|Secondary|Summary of Pasireotide Concentrations Following Intramuscular Injection of Pasireotide LAR 60mg||Cycle 1 Day 21, Cycle 2 Day 29|PK analysis set consisted of all patients who had at least 1 pasireotide LAR injection or 1 everolimus administration and 1 evaluable concentration data.||ng/mL||Standard Deviation|Mean
696678|NCT01374451|Secondary|Summary of Pharmacokinetics (PK) for Everolimus for Tmax||Cycle 2 Day 1|PK analysis set consisted of all patients who had at least 1 pasireotide LAR injection or 1 everolimus administration and 1 evaluable concentration data.||hr||Inter-Quartile Range|Median
696679|NCT01374451|Secondary|Summary of Pharmacokinetics (PK) for Everolimus for Cmax and Cmin||Cycle 2 Day 1|PK analysis set consisted of all patients who had at least 1 pasireotide LAR injection or 1 everolimus administration and 1 evaluable concentration data.||ng/mL||Standard Deviation|Mean
696680|NCT01374451|Secondary|Summary of Pharmacokinetics (PK) for Everolimus for CL/F||Cycle 2 Day 1|PK analysis set consisted of all patients who had at least 1 pasireotide LAR injection or 1 everolimus administration and 1 evaluable concentration data.||L/hr||Standard Deviation|Mean
696681|NCT01374451|Secondary|Summary of Pharmacokinetics (PK) for Everolimus for AUClast||Cycle 2 Day 1|PK analysis set consisted of all patients who had at least 1 pasireotide LAR injection or 1 everolimus administration and 1 evaluable concentration data.||ng*hr/mL||Standard Deviation|Mean
697308|NCT01368211|Primary|Change in Maximum Amplitude at 1-hour Post-transfusion|Thromboelastography (TEG) Parameter: Pre- to post-transfusional modification of Maximum Amplitude at 1-hour post-transfusion|pre-transfusion, 1-hour post transfusion|||mm||Standard Deviation|Mean
696682|NCT01374451|Secondary|Disease Control Rate (DCR) as Per Radiology Review|Disease control rate is the percentage of patients with a best overall response of CR or PR or stable disease (SD) determined by the local radiologist according to the Response Evaluation Criteria In Solid Tumors Criteria (RECIST) Version 1.0. CR: Disappearance of all nontarget lesions. PR: At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the smallest sum of the longest diameter of all target lesions recorded at or after baseline. SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease (PD). PD: Any progression ≤ 18 weeks after randomization (and not qualifying for CR, PR or stable disease SD.|Once 80 PFS events had occurred|The FAS consisted of all randomized patients.1 patient in the everolimus + pasireotide LAR treatment arm was untreated due to administrative problems. The study was terminated because the study did not meet its primary objective so minimal efficacy data was obtained.||Percentage of participants||95% Confidence Interval|Number
696683|NCT01374451|Secondary|PFS and the Predictive Probability of Success in Phase III|105 PFS events expected after approximately 36 months|Once 105 PFS events had occurred occurred|Since the study was terminated because the study did not meet its primary objective which was based on PFS as per local radiology assessment, minimal efficacy data was obtained. Only 80 PFS events occurred before study was terminated so 105 PFS events was not reached to analyze this data.|||||
696684|NCT01374451|Secondary|Overall Survival (OS) Using Kaplan Meier Method|Overall survival was defined as the time from date of randomization/start of treatment to date of death due to any cause. If a patient is not known to have died, survival was to be censored at the date of last contact.|Once 80 PFS events had occurred|The FAS consisted of all randomized patients.1 patient in the everolimus + pasireotide LAR treatment arm was untreated due to administrative problems. The study was terminated because the study did not meet its primary objective so minimal efficacy data was obtained.||Percentage of participants||95% Confidence Interval|Number
696685|NCT01374451|Secondary|Duration of Response (DoR)|80 PFS are expected after approximately 24 months. Kaplan Meier was initially planned to be used to depict duration of response by treatment group and by stratum. Later based on the mode of action of everolimus and pasireotide and based on study experience, only a low number of objective responses per RECIST were expected. Therefore, protocol was amended to only list duration of response, and confirmed responses were flagged in the listing. Hence, statistical analyses were not planned and such data are not available for the following table.|Once 80 PFS events had occurred|The FAS consisted of all randomized patients. Only a low number of objective responses per RECIST was expected. Therefore, protocol was amended to only list duration of response, and confirmed responses were flagged in the listing. Hence, statistical analyses were not planned and such data are not available for the following table.|||||
696686|NCT01374451|Secondary|Objective Response Rate (ORR) as Per Radiology Review|"Objective response was determined by the local radiologist according to the RECIST Version 1.0. ORR is the percentage of patients with a best overall response of complete response (CR) or partial response (PR). This is also referred to as Overall response rate.
CR: Disappearance of all nontarget lesions. PR: At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the smallest sum of the longest diameter of all target lesions recorded at or after baseline."|Once 80 PFS events had occurred|The FAS consisted of all randomized patients.1 patient in the everolimus + pasireotide LAR treatment arm was untreated due to administrative problems. The study was terminated because the study did not meet its primary objective so minimal efficacy data was obtained.||Percentage of participants||95% Confidence Interval|Number
696687|NCT01374451|Secondary|Safety and Tolerability Profile of Everolimus Alone or in Combination With Pasireotide LAR|Consisted of monitoring and recording the rate, type, severity, and causal relationship of adverse events (AEs) and serious AEs (SAEs) to treatment. The safety analysis was based mainly on the frequency of AEs or SAEs and on the number of laboratory values that fell outside of pre-determined range.|Once 80 PFS events had occurred|"Safety analysis population included all patients who received any study medication (i.e. at least 1 dose of the study drug in case of monotherapy or at least 1 dose of any 1 compound of the study treatment in case of a combination therapy) with a post-Baseline safety assessment.
See Adverse Events (AE) section for all AEs collected."||Participants|||Number
696688|NCT01374451|Primary|Progression-free Survival (PFS) Per Local Radiological Review|PFS per RECIST 1.0. (Response Evaluation Criteria in Solid Tumors). PFS was defined as the time from the date of randomization to the date of the first radiologically documented disease progression or death due to any cause.|Once 80 PFS events had occurred aproximately after 24 months|"The FAS consisted of all randomized patients. Following the intention to treat principle patients were analyzed according to the treatment (and stratum) they were assigned to at randomization.
One patient in the everolimus + pasireotide LAR treatment arm was untreated due to administrative problems."||months||95% Confidence Interval|Median
696689|NCT01374438|Secondary|Change From Baseline in HMW Adiponectin of MSDC-0160 or Placebo Over 12 Weeks|Estimate the effect of 150 mg daily MSDC-0160 versus placebo on levels of high molecular weight adiponectin. Increases in HMW adiponectin suggest improved insulin sensitivity.|Days 1(baseline) and 91|||micromol/L||Standard Deviation|Mean
696690|NCT01374438|Secondary|Change From Baseline in Cognitive Function as Estimate With the Executive Function Scale|Estimate of the effect of 3-months of MSDC-0160 treatment versus placebo on a 9-item executive function scale. A summary measure of executive function was constructed by converting raw scores from 9 individual tests into z-scores as described by Bennett DA, et al., The Rush Memory and Aging Project: study design and baseline characteristics of the study cohort, Neuroepidemiology. 2005;25(4):163-175.|Days 1 (baseline) and 91|One subject in the MSDC-0160 group and 2 subjects in the placebo group were not able to complete the executive function tests at both study time points.||z-score||Standard Deviation|Mean
696691|NCT01374438|Secondary|Change From Baseline in Cognitive Function as Determined by the ADAS-Cog Subscale|Alzheimer’s Disease Assessment Scale – Cognitive Subscale, an assessment of cognitive ability. Scores on 11 individual tasks were summed to produce the reported total score, with a possible range of 0 (no impairment) to 70 (severe impairment).|Days 1 (baseline) and 91|One subject in the MSDC-0160 group and 2 subjects in the placebo group were not able to complete the ADAS-Cog tests at both study time points.||Scores on a scale||Standard Deviation|Mean
697309|NCT01368185|Secondary|Systolic Blood Pressure (SBP)|SBP at baseline and month 3.|Baseline and Month 3|||mmHg||Standard Deviation|Mean
697310|NCT01368185|Secondary|Diastolic Blood Pressure (DBP)|DBP at baseline and month 3.|Baseline and Month 3|||mmHg||Standard Deviation|Mean
696692|NCT01374438|Secondary|Change From Baseline in Global Cognitive Function Tests|Change from baseline in cognitive function, as determined by global cognitive function on a neuropsychological battery of 19 tests, following 3 months treatment with MSDC-0160 versus placebo. A summary measure of global cognitive function was constructed by converting raw scores from 19 individual tests into z-scores as described by Bennett DA, et al., The Rush Memory and Aging Project: study design and baseline characteristics of the study cohort, Neuroepidemiology. 2005;25(4):163-175.|Days 1 (baseline) and 91|||z-scores||Standard Deviation|Mean
696693|NCT01374438|Primary|Effects of MSDC-0160 on Cerebral Metabolic Glucose Rate or Placebo Over 12 Weeks in Pre-specified Regions of Interest Analysis Referenced to Cerebellum|Investigate the effect of 150 mg daily MSDC-0160 vs placebo on 3-month change in brain glucose utilization using FDG-PET pre-specified regions of interest analysis referenced to cerebellum, including five bilateral regions: posterior cingulate, parietal cortex (angular gyrus), lateral temporal cortex, medial temporal cortex, and anterior cingulate-medial frontal cortex. Results are reported as Standardized Uptake Value Ratios. A change from baseline in the metabolic rate of glucose that is ≥0 indicates maintenance of brain glucose utilization, whereas values <0 indicate a decline in brain glucose utilization.|Days 1(baseline) and 91|Intent-to-treat||Ratio||Standard Deviation|Mean
696694|NCT01374425|Secondary|Percentage of Participants With Complete Liver Metastasis Resection in Participants With High VEGF-A Levels Versus Participants With Low VEGF-A Levels|The timing of resective surgery was not defined in the protocol and was left at the discretion of the Investigator. Resection was classified as R0, R1, or R2 following surgery. R0 was defined as complete resection with clear margins ≥1 mm. The percentage of participants with R0 resection of liver or liver plus lymph node metastases was reported. The 95% CI was computed using normal approximation to the binomial distribution.|At time of resective surgery during study (maximum up to 45 months overall)|"ITT Population; only those participants with liver or liver plus lymph node metastases were included in the analysis. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."||percentage of participants||95% Confidence Interval|Number
696695|NCT01374425|Secondary|Percentage of Participants With Liver Metastasis Resection in Participants With High VEGF-A Levels Versus Participants With Low VEGF-A Levels|The timing of resective surgery was not defined in the protocol and was left at the discretion of the Investigator. Resection was classified as R0, R1, or R2 following surgery. R0 was defined as complete resection with clear margins ≥1 mm. R1 was defined as the presence of exposed tumor or histologically detected tumor cells at the line of transection, or <1 mm microscopic margins. In the case of use of radiofrequency ablation or cryotherapy, the resection was considered as R1. R2 was defined as macroscopic positive margins or incomplete resection at time of surgery. The percentage of participants with resection of liver or liver plus lymph node metastases was reported. The 95% CI was computed using normal approximation to the binomial distribution.|At time of resective surgery during study (maximum up to 45 months overall)|"ITT Population; only those participants with liver or liver plus lymph node metastases were included in the analysis. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."||percentage of participants||95% Confidence Interval|Number
696696|NCT01374425|Secondary|Percentage of Participants With Disease Control According to RECIST Version 1.1 in Participants With High VEGF-A Levels Versus Participants With Low VEGF-A Levels|Disease control was defined as CR, PR, or SD according to RECIST Version 1.1. CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. Confirmation of response at a consecutive assessment was not required. SD was defined as neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for disease progression (≥20% increase in sum of LD of target lesions plus absolute increase ≥5 mm) in reference to the smallest sum of LD on study. The percentage of participants with CR, PR, or SD was reported. The 95% CI was computed using normal approximation to the binomial distribution.|From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."||percentage of participants||95% Confidence Interval|Number
696697|NCT01374425|Secondary|Percentage of Participants With Objective Response According to RECIST Version 1.1 in Participants With Wild-Type KRAS Versus Participants With Mutant KRAS|Objective response was defined as CR or PR according to RECIST Version 1.1. CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. Confirmation of response at a consecutive assessment was not required. The percentage of participants with CR or PR was reported. The 95% CI was computed using normal approximation to the binomial distribution.|From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."||percentage of participants||95% Confidence Interval|Number
696698|NCT01374425|Secondary|Percentage of Participants With Objective Response According to RECIST Version 1.1 in Participants With High VEGF-A Levels Versus Participants With Low VEGF-A Levels|Objective response was defined as CR or PR according to RECIST Version 1.1. CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. Confirmation of response at a consecutive assessment was not required. The percentage of participants with CR or PR was reported. The 95% CI was computed using normal approximation to the binomial distribution.|From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."||percentage of participants||95% Confidence Interval|Number
696699|NCT01374425|Secondary|OS in Participants With Wild-Type KRAS Versus Participants With Mutant KRAS|Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. OS was defined as the time from randomization to death. The median duration of OS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.|From Baseline until death (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."||months||95% Confidence Interval|Median
696700|NCT01374425|Secondary|OS in Participants With High VEGF-A Levels Versus Participants With Low VEGF-A Levels|Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. OS was defined as the time from randomization to death. The median duration of OS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.|From Baseline until death (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."||months||95% Confidence Interval|Median
696701|NCT01374425|Secondary|PFS According to RECIST Version 1.1 in Participants With Wild-Type V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Versus Participants With Mutant KRAS|Tumor assessments were performed according to RECIST Version 1.1. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm. Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy. Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. PFS was defined as the time from randomization to death or disease progression, whichever occurred first. The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.|From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."||months||95% Confidence Interval|Median
696702|NCT01374425|Secondary|Percentage of Participants With Complete Liver Metastasis Resection in Participants With High ERCC-1 Levels Versus Participants With Low ERCC-1 Levels|The timing of resective surgery was not defined in the protocol and was left at the discretion of the Investigator. Resection was classified as R0, R1, or R2 following surgery. R0 was defined as complete resection with clear margins ≥1 mm. The percentage of participants with R0 resection of liver or liver plus lymph node metastases was reported. The 95% CI was computed using normal approximation to the binomial distribution.|At time of resective surgery during study (maximum up to 45 months overall)|"ITT Population; only those participants with liver or liver plus lymph node metastases were included in the analysis. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."||percentage of participants||95% Confidence Interval|Number
696703|NCT01374425|Secondary|Percentage of Participants With Liver Metastasis Resection in Participants With High ERCC-1 Levels Versus Participants With Low ERCC-1 Levels|The timing of resective surgery was not defined in the protocol and was left at the discretion of the Investigator. Resection was classified as R0, R1, or R2 following surgery. R0 was defined as complete resection with clear margins ≥1 mm. R1 was defined as the presence of exposed tumor or histologically detected tumor cells at the line of transection, or <1 mm microscopic margins. In the case of use of radiofrequency ablation or cryotherapy, the resection was considered as R1. R2 was defined as macroscopic positive margins or incomplete resection at time of surgery. The percentage of participants with resection of liver or liver plus lymph node metastases was reported. The 95% CI was computed using normal approximation to the binomial distribution.|At time of resective surgery during study (maximum up to 45 months overall)|"ITT Population; only those participants with liver or liver plus lymph node metastases were included in the analysis. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."||percentage of participants||95% Confidence Interval|Number
696704|NCT01374425|Secondary|Percentage of Participants With Complete Liver Metastasis Resection in Participants With Low ERCC-1 Levels|The timing of resective surgery was not defined in the protocol and was left at the discretion of the Investigator. Resection was classified as R0, R1, or R2 following surgery. R0 was defined as complete resection with clear margins ≥1 mm. The percentage of participants with R0 resection of liver or liver plus lymph node metastases was reported. The 95% CI was computed using normal approximation to the binomial distribution.|At time of resective surgery during study (maximum up to 45 months overall)|"ITT Population; only those participants with liver or liver plus lymph node metastases were included in the analysis. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."||percentage of participants||95% Confidence Interval|Number
696705|NCT01374425|Secondary|Percentage of Participants With Liver Metastasis Resection in Participants With Low ERCC-1 Levels|The timing of resective surgery was not defined in the protocol and was left at the discretion of the Investigator. Resection was classified as R0, R1, or R2 following surgery. R0 was defined as complete resection with clear margins ≥1 mm. R1 was defined as the presence of exposed tumor or histologically detected tumor cells at the line of transection, or <1 mm microscopic margins. In the case of use of radiofrequency ablation or cryotherapy, the resection was considered as R1. R2 was defined as macroscopic positive margins or incomplete resection at time of surgery. The percentage of participants with resection of liver or liver plus lymph node metastases was reported. The 95% CI was computed using normal approximation to the binomial distribution.|At time of resective surgery during study (maximum up to 45 months overall)|"ITT Population; only those participants with liver or liver plus lymph node metastases were included in the analysis. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."||percentage of participants||95% Confidence Interval|Number
696706|NCT01374425|Secondary|Percentage of Participants With Complete Liver Metastasis Resection in Participants With High ERCC-1 Levels|The timing of resective surgery was not defined in the protocol and was left at the discretion of the Investigator. Resection was classified as R0, R1, or R2 following surgery. R0 was defined as complete resection with clear margins ≥1 mm. The percentage of participants with R0 resection of liver or liver plus lymph node metastases was reported. The 95% CI was computed using normal approximation to the binomial distribution.|At time of resective surgery during study (maximum up to 45 months overall)|"ITT Population; only those participants with liver or liver plus lymph node metastases were included in the analysis. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."||percentage of participants||95% Confidence Interval|Number
696867|NCT01372813|Secondary|Progression-free Survival as Defined by the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria|"Progression free survival is defined as the time from initiation of treatment to either progression or death.
RECIST evaluates tumor response. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria. For detailed information about RECIST, see the protocol Link module."|12 months|||Days||95% Confidence Interval|Median
696707|NCT01374425|Secondary|Percentage of Participants With Liver Metastasis Resection in Participants With High ERCC-1 Levels|The timing of resective surgery was not defined in the protocol and was left at the discretion of the Investigator. Resection was classified as R0, R1, or R2 following surgery. R0 was defined as complete resection with clear margins ≥1 mm. R1 was defined as the presence of exposed tumor or histologically detected tumor cells at the line of transection, or <1 mm microscopic margins. In the case of use of radiofrequency ablation or cryotherapy, the resection was considered as R1. R2 was defined as macroscopic positive margins or incomplete resection at time of surgery. The percentage of participants with resection of liver or liver plus lymph node metastases was reported. The 95% CI was computed using normal approximation to the binomial distribution.|At time of resective surgery during study (maximum up to 45 months overall)|"ITT Population; only those participants with liver or liver plus lymph node metastases were included in the analysis. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."||percentage of participants||95% Confidence Interval|Number
696708|NCT01374425|Secondary|Percentage of Participants With Complete Liver Metastasis Resection|The timing of resective surgery was not defined in the protocol and was left at the discretion of the Investigator. Resection was classified as R0, R1, or R2 following surgery. R0 was defined as complete resection with clear margins ≥1 mm. The percentage of participants with R0 resection of liver or liver plus lymph node metastases was reported. The 95% CI was computed using normal approximation to the binomial distribution.|At time of resective surgery during study (maximum up to 45 months overall)|ITT Population; only those participants with liver or liver plus lymph node metastases were included in the analysis.||percentage of participants||95% Confidence Interval|Number
696709|NCT01374425|Secondary|Percentage of Participants With Liver Metastasis Resection|The timing of resective surgery was not defined in the protocol and was left at the discretion of the Investigator. Resection was classified as R0, R1, or R2 following surgery. R0 was defined as complete resection with clear margins ≥1 mm. R1 was defined as the presence of exposed tumor or histologically detected tumor cells at the line of transection, or <1 mm microscopic margins. In the case of use of radiofrequency ablation or cryotherapy, the resection was considered as R1. R2 was defined as macroscopic positive margins or incomplete resection at time of surgery. The percentage of participants with resection of liver or liver plus lymph node metastases was reported. The 95% CI was computed using normal approximation to the binomial distribution.|At time of resective surgery during study (maximum up to 45 months overall)|ITT Population; only those participants with liver or liver plus lymph node metastases were included in the analysis.||percentage of participants||95% Confidence Interval|Number
696710|NCT01374425|Secondary|Percentage of Participants With Disease Control According to RECIST Version 1.1 in Participants With High ERCC-1 Levels Versus Participants With Low ERCC-1 Levels|Disease control was defined as CR, PR, or SD according to RECIST Version 1.1. CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. Confirmation of response at a consecutive assessment was not required. SD was defined as neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for disease progression (≥20% increase in sum of LD of target lesions plus absolute increase ≥5 mm) in reference to the smallest sum of LD on study. The percentage of participants with CR, PR, or SD was reported. The 95% CI was computed using normal approximation to the binomial distribution.|From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."||percentage of participants||95% Confidence Interval|Number
696711|NCT01374425|Secondary|Percentage of Participants With Disease Control According to RECIST Version 1.1 in Participants With Low ERCC-1 Levels|Disease control was defined as CR, PR, or SD according to RECIST Version 1.1. CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. Confirmation of response at a consecutive assessment was not required. SD was defined as neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for disease progression (≥20% increase in sum of LD of target lesions plus absolute increase ≥5 mm) in reference to the smallest sum of LD on study. The percentage of participants with CR, PR, or SD was reported. The 95% CI was computed using normal approximation to the binomial distribution.|From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."||percentage of participants||95% Confidence Interval|Number
696712|NCT01374425|Secondary|Percentage of Participants With Disease Control According to RECIST Version 1.1 in Participants With High ERCC-1 Levels|Disease control was defined as CR, PR, or SD according to RECIST Version 1.1. CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. Confirmation of response at a consecutive assessment was not required. SD was defined as neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for disease progression (≥20% increase in sum of LD of target lesions plus absolute increase ≥5 mm) in reference to the smallest sum of LD on study. The percentage of participants with CR, PR, or SD was reported. The 95% CI was computed using normal approximation to the binomial distribution.|From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."||percentage of participants||95% Confidence Interval|Number
696713|NCT01374425|Secondary|Percentage of Participants With Disease Control According to RECIST Version 1.1|Disease control was defined as CR, PR, or stable disease (SD) according to RECIST Version 1.1. CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. Confirmation of response at a consecutive assessment was not required. SD was defined as neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for disease progression (≥20% increase in sum of LD of target lesions plus absolute increase ≥5 mm) in reference to the smallest sum of LD on study. The percentage of participants with CR, PR, or SD was reported. The 95% CI was computed using normal approximation to the binomial distribution.|From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)|ITT Population||percentage of participants||95% Confidence Interval|Number
696714|NCT01374425|Secondary|Percentage of Participants With Objective Response According to RECIST Version 1.1 in Participants With High ERCC-1 Levels Versus Participants With Low ERCC-1 Levels|Objective response was defined as CR or PR according to RECIST Version 1.1. CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. Confirmation of response at a consecutive assessment was not required. The percentage of participants with CR or PR was reported. The 95% CI was computed using normal approximation to the binomial distribution.|From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."||percentage of participants||95% Confidence Interval|Number
696715|NCT01374425|Secondary|Percentage of Participants With Objective Response According to RECIST Version 1.1 in Participants With Low ERCC-1 Levels|Objective response was defined as CR or PR according to RECIST Version 1.1. CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. Confirmation of response at a consecutive assessment was not required. The percentage of participants with CR or PR was reported. The 95% CI was computed using normal approximation to the binomial distribution.|From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."||percentage of participants||95% Confidence Interval|Number
696716|NCT01374425|Secondary|Percentage of Participants With Objective Response According to RECIST Version 1.1 in Participants With High ERCC-1 Levels|Objective response was defined as CR or PR according to RECIST Version 1.1. CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. Confirmation of response at a consecutive assessment was not required. The percentage of participants with CR or PR was reported. The 95% CI was computed using normal approximation to the binomial distribution.|From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."||percentage of participants||95% Confidence Interval|Number
696717|NCT01374425|Secondary|Percentage of Participants With Objective Response According to RECIST Version 1.1|Objective response was defined as complete response (CR) or partial response (PR) according to RECIST Version 1.1. CR was defined as disappearance of all target lesions and short-axis reduction to less than (<) 10 mm of any pathological lymph nodes. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. Confirmation of response at a consecutive assessment was not required. The percentage of participants with CR or PR was reported. The 95% CI was computed using normal approximation to the binomial distribution.|From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)|ITT Population||percentage of participants||95% Confidence Interval|Number
696718|NCT01374425|Secondary|OS in Participants With High ERCC-1 Levels Versus Participants With Low ERCC-1 Levels|Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. OS was defined as the time from randomization to death. The median duration of OS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.|From Baseline until death (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."||months||95% Confidence Interval|Median
696719|NCT01374425|Secondary|OS in Participants With Low ERCC-1 Levels|Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. OS was defined as the time from randomization to death. The median duration of OS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.|From Baseline until death (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."||months||95% Confidence Interval|Median
696720|NCT01374425|Secondary|OS in Participants With High ERCC-1 Levels|Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. OS was defined as the time from randomization to death. The median duration of OS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.|From Baseline until death (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."||months||95% Confidence Interval|Median
696721|NCT01374425|Secondary|Overall Survival (OS)|Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. OS was defined as the time from randomization to death. The median duration of OS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.|From Baseline until death (maximum up to 45 months overall)|ITT Population||months||95% Confidence Interval|Median
696722|NCT01374425|Secondary|PFS According to RECIST Version 1.1 in Participants With Low ERCC-1 and Low VEGF-A Levels|Tumor assessments were performed according to RECIST Version 1.1. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm. Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy. Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. PFS was defined as the time from randomization to death or disease progression, whichever occurred first. The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.|From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."||months||95% Confidence Interval|Median
696884|NCT01372501|Secondary|Change in Absolute Weight Loss From Baseline to Week 52||Week 52|Per Protocol Population (n=14); subjects who had the device implanted for 52 weeks.||kg||Standard Deviation|Mean
697311|NCT01368185|Secondary|The Percentage of Patients With Hyperuricemia|Hyperuricemia was defined as SUA >6.6mg/dL in females and >7.7mg/dL in males.|Baseline and Month 3|||percent of participants|||Number
696723|NCT01374425|Secondary|PFS According to RECIST Version 1.1 in Participants With Low ERCC-1 and High VEGF-A Levels|Tumor assessments were performed according to RECIST Version 1.1. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm. Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy. Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. PFS was defined as the time from randomization to death or disease progression, whichever occurred first. The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.|From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."||months||95% Confidence Interval|Median
696724|NCT01374425|Secondary|PFS According to RECIST Version 1.1 in Participants With High ERCC-1 and Low VEGF-A Levels|Tumor assessments were performed according to RECIST Version 1.1. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm. Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy. Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. PFS was defined as the time from randomization to death or disease progression, whichever occurred first. The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.|From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."||months||95% Confidence Interval|Median
696725|NCT01374425|Secondary|PFS According to RECIST Version 1.1 in Participants With High ERCC-1 and High VEGF-A Levels|Tumor assessments were performed according to RECIST Version 1.1. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm. Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy. Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. PFS was defined as the time from randomization to death or disease progression, whichever occurred first. The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.|From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."||months||95% Confidence Interval|Median
696726|NCT01374425|Primary|PFS According to RECIST Version 1.1 in Participants With High Vascular Endothelial Growth Factor (VEGF)-A Levels Versus Participants With Low VEGF-A Levels|Tumor assessments were performed according to RECIST Version 1.1. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm. Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy. Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. PFS was defined as the time from randomization to death or disease progression, whichever occurred first. The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.|From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."||months||95% Confidence Interval|Median
696727|NCT01374425|Primary|PFS According to RECIST Version 1.1 in Participants With High ERCC-1 Levels Versus Participants With Low ERCC-1 Levels|Tumor assessments were performed according to RECIST Version 1.1. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm. Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy. Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. PFS was defined as the time from randomization to death or disease progression, whichever occurred first. The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.|From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."||months||95% Confidence Interval|Median
696728|NCT01374425|Primary|PFS According to RECIST Version 1.1 in Participants With Low ERCC-1 Levels|Tumor assessments were performed according to RECIST Version 1.1. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm. Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy. Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. PFS was defined as the time from randomization to death or disease progression, whichever occurred first. The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.|From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."||months||95% Confidence Interval|Median
696787|NCT01374269|Secondary|Roland-Morris Questionnaire|Improvement in function assessed by the Roland-Morris questionnaire, a widely used health status measure for low back pain. The RMDQ can be used in research or clinical practice. Scoring the RMDQ. The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore vary from 0 to 24. It is not recommended to give patients a ‘Yes’ / ‘No’ option. If patients indicate in any way that an item is not applicable to them, the item is scored ‘No’, i.e. the denominator remains 24. Being worst 24.|At the beginning|||units on a scale||Standard Deviation|Mean
696729|NCT01374425|Primary|PFS According to RECIST Version 1.1 in Participants With High ERCC-1 Levels|Tumor assessments were performed according to RECIST Version 1.1. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm. Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy. Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. PFS was defined as the time from randomization to death or disease progression, whichever occurred first. The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.|From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."||months||95% Confidence Interval|Median
696730|NCT01374425|Primary|Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1|Tumor assessments were performed according to RECIST Version 1.1. Disease progression was defined as greater than or equal to (≥) 20 percent (%) increase in sum of largest diameters (LD) of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 millimeters (mm). Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy. Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. PFS was defined as the time from randomization to death or disease progression, whichever occurred first. The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months. The 95% confidence interval (CI) was computed using the method of Brookmeyer and Crowley.|From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)|Intent-to-treat (ITT) Population||months||95% Confidence Interval|Median
696731|NCT01374269|Secondary|Medical Consultations.|This result shows, the total number of participants received additional medical consultations.|24 weeks|We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.||participants|||Number
696732|NCT01374269|Secondary|Medical Consultations.|This result shows, the total number of participants received additional medical consultations.|12 weeks|We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.||participants|||Number
696733|NCT01374269|Secondary|Medical Consultations.|This result shows, the total number of participants received additional medical consultations.|4 weeks|||participants|||Number
696734|NCT01374269|Secondary|Missing Workdays|This result shows the average of the number of missed work days.|24 weeks|We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.||Days||Standard Deviation|Mean
696735|NCT01374269|Secondary|Missing Workdays|This result shows the average of the number of missed work days.|12 weeks|We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.||Days||Standard Deviation|Mean
696736|NCT01374269|Secondary|Missing Workdays|This result shows the average of the number of missed work days.|4 weeks|||Days||Standard Deviation|Mean
696737|NCT01374269|Secondary|Missing Workdays|This result shows the average of the number of missed work days.|6 weeks before starting|||Days||Standard Deviation|Mean
696738|NCT01374269|Secondary|Treatments Associated With Low Back Pain at 6 Months|we are showing in this result, the number of patients who had to receive any additional treatment in either group. The measure is the number of participants who received additional treatment throughout the duration of the study.|6 months|||participants|||Number
696739|NCT01374269|Secondary|Relapses of Lumbar Pain|The percentage of patients with relapsed of low back pain was measured.|24 weeks|We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.||percentage of participants|||Number
696740|NCT01374269|Secondary|Relapses of Lumbar Pain|The percentage of patients with relapsed of low back pain was measured.|12 weeks|We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.||percentage of participants|||Number
696741|NCT01374269|Secondary|PHQ-9 Patient Health Questionnaire (PHQ-9) Depression|Depression was measured with the Patient Health Questionnaire (PHQ-9), which ranged from 0 (no depression) to 27 (severe depression).|24 weeks|We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.||units on a scale||Standard Deviation|Mean
696742|NCT01374269|Secondary|PHQ-9 Patient Health Questionnaire (PHQ-9) Depression|Depression was measured with the Patient Health Questionnaire (PHQ-9), which ranged from 0 (no depression) to 27 (severe depression).|12 weeks|We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.||units on a scale||Standard Deviation|Mean
696743|NCT01374269|Secondary|PHQ-9 Patient Health Questionnaire (PHQ-9) Depression|Depression was measured with the Patient Health Questionnaire (PHQ-9), which ranged from 0 (no depression) to 27 (severe depression).|At the beginning|||units on a scale||Standard Deviation|Mean
696744|NCT01374269|Secondary|PHQ-9 Patient Health Questionnaire (PHQ-9) Depression|Depression was measured with the Patient Health Questionnaire (PHQ-9), which ranged from 0 (no depression) to 27 (severe depression).|4 weeks|||units on a scale||Standard Deviation|Mean
697312|NCT01368185|Primary|Serum Uric Acid (SUA) Level|SUA at baseline and Month 3.|Baseline and Month 3|||mg/dL||Standard Deviation|Mean
696745|NCT01374269|Secondary|Quality of Life, Vitality.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Vitality.|24 weeks|We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.||units on a scale||Standard Deviation|Mean
696746|NCT01374269|Secondary|Quality of Life, Vitality.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Vitality.|12 weeks|We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.||units on a scale||Standard Deviation|Mean
696747|NCT01374269|Secondary|Quality of Life, Vitality.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Vitality.|4 weeks|||units on a scale||Standard Deviation|Mean
696748|NCT01374269|Secondary|Quality of Life, Vitality.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Vitality.|At the beginning|||units on a scale||Standard Deviation|Mean
696749|NCT01374269|Secondary|Quality of Life, Mental Health.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Mental Health.|24 weeks|We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.||units on a scale||Standard Deviation|Mean
696750|NCT01374269|Secondary|Quality of Life, Mental Health.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Mental Health.|12 weeks|We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.||units on a scale||Standard Deviation|Mean
696751|NCT01374269|Secondary|Quality of Life, Mental Health.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Mental Health.|4 weeks|||units on a scale||Standard Deviation|Mean
696752|NCT01374269|Secondary|Quality of Life, Mental Health.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Mental Health.|At the beginning|||units on a scale||Standard Deviation|Mean
696802|NCT01374087|Secondary|Overall Survival|"Overall survival was defined as the time in months from diagnosis (biopsy date for local recurrence) to death due to any cause, the last visit or the loss to follow-up.
No deaths were reported during the study. As the study was prematurely terminated, no data analyses were conducted. The study was terminated prior to completion of the 5-year follow-up."|5 years||||||
696753|NCT01374269|Secondary|Quality of Life, General Health Perceptions.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: General Health Perceptions.|24 weeks|We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.||units on a scale||Standard Deviation|Mean
696754|NCT01374269|Secondary|Quality of Life, General Health Perceptions.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: General Health Perceptions.|12 weeks|We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.||units on a scale||Standard Deviation|Mean
696755|NCT01374269|Secondary|Quality of Life, General Health Perceptions.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: General Health Perceptions.|4 weeks|||units on a scale||Standard Deviation|Mean
696756|NCT01374269|Secondary|Quality of Life, General Health Perceptions.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: General Health Perceptions.|At the beginning|||units on a scale||Standard Deviation|Mean
696757|NCT01374269|Secondary|Quality of Life, Social Function.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Social Function.|24 weeks|We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.||units on a scale||Standard Deviation|Mean
696758|NCT01374269|Secondary|Quality of Life, Social Function.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Social Function.|12 weeks|We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.||units on a scale||Standard Deviation|Mean
696759|NCT01374269|Secondary|Quality of Life, Social Function.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Social Function.|4 weeks|||units on a scale||Standard Deviation|Mean
696760|NCT01374269|Secondary|Quality of Life, Social Function.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Social Function.|At the beginning|||units on a scale||Standard Deviation|Mean
696885|NCT01372501|Primary|Assessment of the % Excess Weight Loss at Week 52 or Last Assessment|Excess weight was determined from ideal body weights based on a BMI of 25 kg/m2|52 Weeks|Full Analysis Set (FAS) population had a device successfully implanted.||%EWL||Standard Deviation|Mean
696761|NCT01374269|Secondary|Quality of Life, Physical Function.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Function.|24 weeks|We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.||units on a scale||Standard Deviation|Mean
696762|NCT01374269|Secondary|Quality of Life, Physical Function.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Function.|12 weeks|We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.||units on a scale||Standard Deviation|Mean
696763|NCT01374269|Secondary|Quality of Life, Physical Function.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Function.|4 weeks|||units on a scale||Standard Deviation|Mean
696764|NCT01374269|Secondary|Quality of Life, Physical Function.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Function.|At the beginning|||units on a scale||Standard Deviation|Mean
696765|NCT01374269|Secondary|Quality of Life, Physical Performance.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Performance.|24 weeks|We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.||units on a scale||Standard Deviation|Mean
696766|NCT01374269|Secondary|Quality of Life, Physical Performance.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Performance|12 weeks|We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.||units on a scale||Standard Deviation|Mean
696767|NCT01374269|Secondary|Quality of Life, Physical Performance.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Performance|4 weeks|||units on a scale||Standard Deviation|Mean
696768|NCT01374269|Secondary|Quality of Life, Physical Performance.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Performance|At the beginning|||units on a scale||Standard Deviation|Mean
697313|NCT01368081|Other Pre-specified|Confirmed Hypoglycaemic Adverse Events|Number of patients with confirmed hypoglycaemic adverse events|After the first drug intake until 7 days after the last treatment administration, up to 383 days|Treated patients||participants|||Number
696769|NCT01374269|Secondary|Quality of Life, Emotional Performance.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Emotional Performance.|24 weeks|We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.||units on a scale||Standard Deviation|Mean
696770|NCT01374269|Secondary|Quality of Life, Emotional Performance.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Emotional Performance.|12 weeks|We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.||units on a scale||Standard Deviation|Mean
696771|NCT01374269|Secondary|Quality of Life, Emotional Performance.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Emotional Performance.|4 weeks|||units on a scale||Standard Deviation|Mean
696772|NCT01374269|Secondary|Quality of Life, Emotional Performance.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Emotional Performance.|At the beginning|||units on a scale||Standard Deviation|Mean
696773|NCT01374269|Secondary|Quality of Life, Bodily Pain|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: bodily pain.|24 weeks|We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.||units on a scale||Standard Deviation|Mean
696774|NCT01374269|Secondary|Quality of Life, Bodily Pain|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: bodily pain.|12 weeks|We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.||units on a scale||Standard Deviation|Mean
696775|NCT01374269|Secondary|Quality of Life, Bodily Pain|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: bodily pain.|4 weeks|||units on a scale||Standard Deviation|Mean
696776|NCT01374269|Secondary|Quality of Life, Bodily Pain|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: bodily pain.|At the beginning|||units on a scale||Standard Deviation|Mean
697025|NCT01370863|Secondary|Change From Baseline in the Number of Days With Heartburn and/or Regurgitation at 4 Weeks||Baseline and 4 weeks|Pharmacodynamics Population (PD) defined as all randomized subjects with at least 1 administration of the investigational product and with both a baseline and post-baseline PD assessment.||Number of days||Standard Deviation|Mean
696777|NCT01374269|Secondary|Quality of Life, Change in Health|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: change in health.|24 weeks|We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.||units on a scale||Standard Deviation|Mean
696778|NCT01374269|Secondary|Quality of Life, Change in Health|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: change in health.|12 weeks|We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.||units on a scale||Standard Deviation|Mean
696779|NCT01374269|Secondary|Quality of Life, Change in Health|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: change in health.|4 weeks|||units on a scale||Standard Deviation|Mean
696780|NCT01374269|Primary|Visual Analogue Scale of Pain|The best result is 0 and the worst is 100, Pain relief more than 25 mm on the Visual Analogue Scale, assessed 24 weeks after intervention.|24 weeks|We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.||units on a scale||Standard Deviation|Mean
696781|NCT01374269|Primary|Visual Analogue Scale of Pain|In the VAS the best result is 0 and the worst is 100. The primary outcome was pain improvement of ≥25 mm on the Visual Analog Scale (VAS) (0 [no pain] to 100 [maximum pain]) at 12 weeks.|12 weeks|We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.||units on a scale||Standard Deviation|Mean
696782|NCT01374269|Primary|Visual Analogue Scale of Pain|In the VAS the best result is 0 and the worst is 100. The primary outcome was pain improvement of ≥25 mm on the Visual Analog Scale (VAS) (0 [no pain] to 100 [maximum pain]) at 4 weeks.|4 weeks|||units on a scale||Standard Deviation|Mean
696783|NCT01374269|Secondary|Quality of Life, Change in Health|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: change in health.|At the beginning|||units on a scale||Standard Deviation|Mean
696784|NCT01374269|Secondary|Roland-Morris Questionnaire|Improvement in function assessed by the Roland-Morris questionnaire, a widely used health status measure for low back pain. The RMDQ can be used in research or clinical practice. Scoring the RMDQ. The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore vary from 0 to 24. It is not recommended to give patients a ‘Yes’ / ‘No’ option. If patients indicate in any way that an item is not applicable to them, the item is scored ‘No’, i.e. the denominator remains 24. Being worst 24.|24 weeks|We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.||units on a scale||Standard Deviation|Mean
696785|NCT01374269|Secondary|Roland-Morris Questionnaire|Improvement in function assessed by the Roland-Morris questionnaire, a widely used health status measure for low back pain. The RMDQ can be used in research or clinical practice. Scoring the RMDQ. The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore vary from 0 to 24. It is not recommended to give patients a ‘Yes’ / ‘No’ option. If patients indicate in any way that an item is not applicable to them, the item is scored ‘No’, i.e. the denominator remains 24. Being worst 24.|12 weeks|We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.||units on a scale||Standard Deviation|Mean
696786|NCT01374269|Secondary|Roland-Morris Questionnaire|Improvement in function assessed by the Roland-Morris questionnaire, a widely used health status measure for low back pain. The RMDQ can be used in research or clinical practice. Scoring the RMDQ. The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore vary from 0 to 24. It is not recommended to give patients a ‘Yes’ / ‘No’ option. If patients indicate in any way that an item is not applicable to them, the item is scored ‘No’, i.e. the denominator remains 24. Being worst 24.|4 weeks|||units on a scale||Standard Deviation|Mean
703396|NCT00094900|Secondary|Mean Change in WBCs|White Blood Cell count change from baseline to 12 months|12 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||x 10^3 cells/microliter||Standard Error|Mean
696788|NCT01374269|Secondary|Oswestry Disability Index|Function was assessed using the Oswestry Disability Index questionnaire Version 2.1a, which ranges from 0 to 100 (greater disability), being worst 100. The Oswestry Disability Index is currently considered by many as the gold standard for measuring degree of disability and estimating quality of life in a person with low back pain. 0% to 20%: Minimal disability, 21%-40%: Moderate Disability, 41%-60%: Severe Disability, 61%-80%: Crippling back pain, 81%-100%: These patients are either bed-bound or have an exaggeration of their symptoms.|24 weeks|We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.||units on a scale||Standard Deviation|Mean
696789|NCT01374269|Secondary|Oswestry Disability Index|Function was assessed using the Oswestry Disability Index questionnaire Version 2.1a, which ranges from 0 to 100 (greater disability), being worst 100. The Oswestry Disability Index is currently considered by many as the gold standard for measuring degree of disability and estimating quality of life in a person with low back pain. 0% to 20%: Minimal disability, 21%-40%: Moderate Disability, 41%-60%: Severe Disability, 61%-80%: Crippling back pain, 81%-100%: These patients are either bed-bound or have an exaggeration of their symptoms.|12 weeks|We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.||units on a scale||Standard Deviation|Mean
696790|NCT01374269|Secondary|Oswestry Disability Index|Function was assessed using the Oswestry Disability Index questionnaire Version 2.1a, which ranges from 0 to 100 (greater disability), being worst 100. The Oswestry Disability Index is currently considered by many as the gold standard for measuring degree of disability and estimating quality of life in a person with low back pain. 0% to 20%: Minimal disability, 21%-40%: Moderate Disability, 41%-60%: Severe Disability, 61%-80%: Crippling back pain, 81%-100%: These patients are either bed-bound or have an exaggeration of their symptoms.|4 weeks|||units on a scale||Standard Deviation|Mean
696791|NCT01374269|Secondary|Oswestry Disability Index|Function was assessed using the Oswestry Disability Index questionnaire Version 2.1a, which ranges from 0 to 100 (greater disability), being worst 100. The Oswestry Disability Index is currently considered by many as the gold standard for measuring degree of disability and estimating quality of life in a person with low back pain. 0% to 20%: Minimal disability, 21%-40%: Moderate Disability, 41%-60%: Severe Disability, 61%-80%: Crippling back pain, 81%-100%: These patients are either bed-bound or have an exaggeration of their symptoms.|At the beginning|||units on a scale||Standard Deviation|Mean
696792|NCT01374269|Primary|Visual Analogue Scale of Pain|In the Visual Analogue Sacale the best result is 0 and the worst is 100, The primary outcome was pain the mesurement of the Visual Analog Scale (VAS) (0 [no pain] to 100 [maximum pain]) at the beginning.|At the beginning|||units on a scale||Standard Deviation|Mean
696793|NCT01374178|Secondary|Number of Participants With Clinically Significant Effects|Clinically significant effects were defined as serious and nonserious adverse events. A summary of serious and all other nonserious adverse events is located in the Reported Adverse Event module.|Baseline up to 30 days|All randomized participants were included in the analysis.||participants|||Number
696794|NCT01374178|Secondary|Time of Maximum Glucose Infusion Rate (tRmax)||Periods 1 and 2: Baseline up to 24 hours|All randomized participants who received at least 1 dose of study drug, completed at least 1 clamp procedure, and had evaluable glucodynamic data.||hour (h)||Full Range|Median
696795|NCT01374178|Secondary|Total Glucose Infused (Gtot)||Periods 1 and 2: Baseline up to 24 hours|All randomized participants who received at least 1 dose of study drug, completed at least 1 clamp procedure, and had evaluable glucodynamic data were included in the analysis.||gram (g)||Geometric Coefficient of Variation|Geometric Mean
696796|NCT01374178|Secondary|Maximum Glucose Infusion Rate (Rmax)||Periods 1 and 2: Baseline up to 24 hours|All randomized participants who received at least 1 dose of study drug, completed at least 1 clamp procedure, and had evaluable glucodynamic data were included in the analysis.||grams per hour (g/h)||Geometric Coefficient of Variation|Geometric Mean
696797|NCT01374178|Secondary|Pharmacokinetics: Maximum Concentration (Cmax)||Periods 1 and 2: Baseline up to 24 hours|All randomized participants who received at least 1 dose of study drug, completed at least 1 clamp procedure, and had evaluable pharmacokinetic data were included in the analysis.||picomole per liter (pmol/L)||Geometric Coefficient of Variation|Geometric Mean
696798|NCT01374178|Primary|Pharmacokinetics: Area Under the Concentration-Time Curve (AUC)|AUC from time zero to 24 hours (AUC0-24) is reported for this outcome measure.|Periods 1 and 2: Baseline up to 24 hours|All randomized participants who received at least 1 dose of study drug, completed at least 1 clamp procedure, and had evaluable pharmacokinetic data were included in the analysis.||picomole*hour per liter (pmol*hr/L)||Geometric Coefficient of Variation|Geometric Mean
696799|NCT01374087|Secondary|Quality of Life (QoL) Modifications (Spanish Version of the Expanded Prostate Cancer Index Composite (EPIC) Questionnaire)|"EPIC assessed the disease-specific aspects of prostate cancer and its therapies and comprised four summary domains (Urinary, Bowel, Sexual and Hormonal). Factor analysis supported dividing the Urinary Domain Summary Score into two different Incontinence and Irritative/Obstructive subscales. In addition, each Domain Summary Score had measurable Function Subscale and Bother Subscale components. Response options for each EPIC item formed a Likert scale, and multi-item scale scores were transformed linearly to a 0-100 scale, with higher scores representing better Health-Related QoL.
As the study was prematurely terminated, no data analyses were conducted. The study was terminated prior to completion of the 5-year follow-up."|At every visit (except for Visit 2 (treatment administration visit))||||||
696800|NCT01374087|Secondary|Change in PSA Levels|"Blood samples were to be drawn for serum PSA at study initiation, and then at 3, 6, 12, 18, 24, 30, 36, 48 and 60 months.
As the study was prematurely terminated, no data analyses were conducted. The study was terminated prior to completion of the 5-year follow-up."|5 years||||||
696801|NCT01374087|Secondary|Change in Total Testosterone Level|"Blood samples were drawn for serum testosterone at study initiation, and then at 3, 6 and 12 months.
As the study was prematurely terminated, no data analyses were conducted. The study was terminated prior to completion of the 5-year follow-up."|12 months||||||
697164|NCT01369784|Secondary|Relationship Between Global Response Rate to 2nd (Second) Line of Treatment and Bcl-2 Expression at Diagnosis|Global response rate was assessed using the National Cancer Institute-sponsored Working Group guidelines. Responses are: complete response, partial response, stable disease, progression and relapse|At diagnosis|||participants|||Number
696803|NCT01374087|Secondary|BFFS Percentage 5 Years From Treatment Initiation|"A subject had a biochemical failure if there was an increase of PSA of 2 ng/mL or more in comparison with the pre-study nadir PSA confirmed in the course of follow-up by a second value after 3 or more weeks or with diagnosis of a new clinical recurrence of their prostate cancer over the 5-year follow-up.
As the study was prematurely terminated, no data analyses were conducted. The study was terminated prior to completion of the 5-year follow-up."|5 years||||||
696804|NCT01374087|Secondary|Time to Progression|"Time to progression (in months) was measured from the informed consent date to the date of first event occurrence. Progression was defined as either: death from all causes or disease progression (defined as PSA increased by 2 ng/mL as compared to the pre-trial nadir PSA, confirmed during follow-up by a second value after 3 or more weeks, or the diagnosis of a new clinical recurrence of their prostate cancer (metastasis, new injury, etc.)).
As the study was prematurely terminated, no analyses were conducted. Data for time to progression are listed by subject for those individuals who reported progression."|5 years|A total of 3 subjects in the brachytherapy group and 4 subjects in the brachytherapy + triptorelin 22.5 mg group reported treatment failure. The subject numbers assigned in the study are not presented. The subjects with progression are listed as Subjects 1 to 7, with these bearing no relation to the subject numbers used for other endpoints herein.||Time to progression (Months)|||Number
696805|NCT01374087|Primary|Biochemical Failure-free Survival (BFFS)|"BFFS was determined by a Prostate Specific Antigen (PSA) increase of 2 ng/mL or more in comparison with the pre-study nadir PSA (as per the Phoenix criteria) confirmed in the course of follow-up by a second value 3 weeks later or longer over the 5-year follow-up. Time to BFFS was defined from the “start date” to the first time when PSA increase of 2 mL was observed.
As the study was prematurely terminated, no analyses were conducted. Data for BFFS are listed by subject for those individuals who reported biochemical failure. Time (months) to biochemical failure is relative to the date of brachytherapy."|5 years|A total of 3 subjects in each treatment group reported biochemical failure. The subject numbers assigned in the study are not presented. The subjects with biochemical failure are listed as Subject 1 to Subject 6, with these bearing no relation to the subject numbers used for other endpoints herein.||Months to Biochemical Failure|||Number
696806|NCT01373918|Secondary|Anthropometric Measurements|Growth will be assessed by weight at the time of hospital discharge (approximately 5 weeks)|approximately 5 weeks|||g||Standard Deviation|Mean
696807|NCT01373918|Secondary|Anthropometric Measurements|Growth will be assessed by growth velocity at 28 days of age|28 days of age|||g/d||Standard Deviation|Mean
696808|NCT01373918|Secondary|Mortality Rate|death|at the end of the hospital stay which is expected to be an average of 5 weeks|||participants|||Number
696809|NCT01373918|Primary|Presence of Cholestasis|Cholestasis will be defined by a direct bilirubin > 2 mg/dL|prior to 100 days of life, hospital discharge, or death whichever comes first|||participants|||Number
696810|NCT01373671|Primary|Efficacy Based on the Area Under the Receiver Operating Characteristic (ROC) Curve in Breasts Analyzed With DBT as an Adjunct to FFDM vs. FFDM Alone|The primary objective of this study was to demonstrate the superiority of DBT and FFDM images together in comparison to FFDM images alone with respect to the ability of readers to detect and diagnose malignant lesions. A comparison of the breast-level ROC areas was used to evaluate the superiority of DBT as an adjunct to FFDM vs. FFDM alone.|1 year|Per protocol 300 subjects were selected for analysis based on 89% power & 5% type one error rate determination.||unitless|breasts|Standard Error|Mean
696811|NCT01373450|Secondary|Change From Baseline in Insulinotrophic Effect (ISR/G) After Single Doses of 0.6 mg Lg, or 1.2 mg Lg, Compared With Single Doses of Placebo or OXM|Participants received on Day (-1) an overnight IV infusion of insulin titrated to achieve baseline fasting plasma glucose on Day 1 of between 90 and 130 mg/dL. Participants also received on Day (-1) a single dose of Lg or placebo for Lg, after which insulin infusion was discontinued. Following overnight fast, participants received on Day 1 a single dose of OXM or placebo for OXM, accompanied by up to 160 minutes of GGI. During GGI glucose (20% D/W) was gradually infused at rates of 2,4,6 and 10 mg/kg/min, with each rate lasting approximately 40 minutes. Glucose (G), insulin and C-peptide levels were measured from blood collected at baseline and during GGI; with the decay in C-peptide concentration used to indirectly estimate the Insulin Secretion Rate (ISR) and hence determine ISR/G.|Baseline and up to 160 minutes after start of GGI|All treated participants. Six participants were treated for two periods with placebo, resulting in placebo n = 18.||ISR (ng/min) / Glucose (mg/dL)||Standard Deviation|Least Squares Mean
696812|NCT01373450|Secondary|Change From Baseline in Gmax After Single Doses of 0.6 mg Lg, or 1.2 mg Lg, Compared With Single Doses of Placebo or OXM|Participants received on Day (-1) an overnight IV infusion of insulin titrated to achieve baseline fasting plasma glucose on Day 1 of between 90 and 130 mg/dL. Participants also received on Day (-1) a single dose of Lg or placebo for Lg, after which insulin infusion was discontinued. Following overnight fast, participants received on Day 1 a single dose of OXM or placebo for OXM, accompanied by up to 160 minutes of GGI. During GGI glucose (20% D/W) was gradually infused at rates of 2,4,6 and 10 mg/kg/min, with each rate lasting approximately 40 minutes. Glucose levels were measured from blood collected at baseline and during GGI to determine the maximum ambient glucose concentration above baseline.|Baseline and up to 160 minutes after start of GGI|All treated participants. Six participants were treated for two periods with placebo, resulting in a placebo n = 18.||mg/dL||Standard Deviation|Least Squares Mean
696819|NCT01373346|Secondary|HbA1c : Good Response Group|"At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 – 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as good response group. We analyzed the change of HbA1c after operation in good response group.
HbA1c is formed in a non-enzymatic glycation pathway by hemoglobin's exposure to plasma glucose and measured by high-performance liquid chromatography (HPLC)
The HbA1c was calculated as a ratio to total hemoglobin."|Before operation, 6 months after operation, Until end of study (on average 14.8 months)|"At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 – 21.7 months). Normal FPG level and HbA1c < 6% without any antidiabetic medications were observed in 11 patients (78.6 %). We called this group as good responder group. We analyzed the change of HbA1c after operation in good responder group."||percentage of glycated hemoglobin||Standard Deviation|Mean
697165|NCT01369784|Primary|Predictive Value of R-IPI at Diagnosis||At diagnosis|||participants|||Number
703397|NCT00094900|Secondary|Mean Change in WBCs|White Blood Cell count change from baseline to 6 months|6 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||x 10^3 cells/microliter||Standard Error|Mean
696813|NCT01373450|Secondary|Change From Baseline in Insulinotrophic Effect (ISR/G) at the Highest Glucose Infusion Rate After Two Periods of Placebo Treatment|The reproducibility of insulinotrophic effects was compared after two separate placebo treatment periods within the same treatment sequence. Participants received on Day (-1) an overnight IV infusion of insulin titrated to achieve baseline fasting plasma glucose on Day 1 of between 90 and 130 mg/dL. Participants also received on Day (-1) a single subcutaneous dose of placebo for Lg, after which insulin infusion was discontinued. Following overnight fast, participants received on Day 1 placebo for OXM, accompanied by up to 160 minutes of GGI. During GGI glucose (20% D/W) was gradually infused at rates of 2,4,6 and 10 mg/kg/min, with each rate lasting approximately 40 minutes. Over these two treatment periods glucose (G), insulin and C-peptide levels were measured from blood collected at the highest glucose infusion rate; with the decay in C-peptide concentration used to indirectly estimate the Insulin Secretion Rate (ISR), and hence to determine the insulinotrophic effect, ISR/G.|Baseline and 160 minutes after start of GGI at each placebo treatment period|Participants within the same treatment sequence who were treated with Placebo in two separate treatment periods. Participants treated with Oxyntomodulin or Liraglutide were not analyzed for this outcome measure.||ISR (ng/mg) / Glucose (mg/dL)||Standard Deviation|Mean
696814|NCT01373450|Primary|Change From Baseline in Beta Cell Sensitivity to Glucose (Φ) After a Single Dose of OXM|Beta cell sensitivity measures the ability to mount an insulin secretory response relative to the level of ambient plasma glucose. Participants received on Day (-1) an overnight IV infusion of insulin titrated to achieve baseline fasting plasma glucose on Day 1 of between 90 and 130 mg/dL. Participants also received on Day (-1) a single dose of Lg or placebo for Lg, after which insulin infusion was discontinued. Following overnight fast, participants received on Day 1 a single dose of OXM or placebo for OXM, accompanied by up to 160 minutes of GGI. During GGI glucose (20% D/W) was gradually infused at rates of 2,4,6 and 10 mg/kg/min, with each rate lasting 40 minutes. Glucose (G), insulin and C-peptide levels were measured from blood collected at baseline and during GGI, with the decay in C-peptide concentration used to indirectly estimate the Insulin Secretion Rate (ISR). Beta Cell Sensitivity (Φ) was determined from the regression of the ISR on ambient plasma glucose (G).|Baseline and up to160 minutes after start of GGI|Participants treated with Oxyntomodulin or placebo. Six participants were treated for two periods with placebo, resulting in placebo n = 18. Participants treated with Liraglutide were not analyzed for this outcome measure.||ISR (ng/mL) / Glucose (mg/dL)||Standard Deviation|Least Squares Mean
696815|NCT01373450|Primary|Change From Baseline in Maximum Ambient Glucose Concentration (Gmax) After a Single Dose of OXM|Participants received on Day (-1) an overnight IV infusion of insulin titrated to achieve baseline fasting plasma glucose on Day 1 of between 90 and 130 mg/dL. Participants also received on Day (-1) a single dose of Lg or placebo for Lg, after which insulin infusion was discontinued. Following overnight fast, participants received on Day 1 OXM or placebo for OXM, accompanied by up to 160 minutes of GGI. During GGI glucose (20% D/W) was gradually infused at rates of 2,4,6 and 10 mg/kg/min, with each rate lasting approximately 40 minutes. Glucose levels were measured from blood collected at baseline and during GGI to determine the maximum ambient glucose concentration above baseline.|Baseline and up to 160 minutes after start of GGI|Participants treated with Oxyntomodulin or placebo. Six participants were treated for two periods with placebo, resulting in placebo n = 18. Participants treated with Liraglutide were not analyzed for this outcome measure.||mg/dL||Standard Deviation|Least Squares Mean
696816|NCT01373450|Primary|Change From Baseline in Time-weighted Average of Glucose Measured by Area Under the Curve (AUC) After a Single Dose of Oxyntomodulin (OXM)|Participants received on Day (-1) an overnight intravenous (IV) infusion of insulin titrated to achieve baseline fasting plasma glucose on Day 1 of between 90 and 130 mg/dL. Participants also received on Day (-1) a single dose of liraglutide (Lg) or placebo for Lg, after which insulin infusion was discontinued. Following overnight fast, participants received on Day 1 OXM or placebo for OXM, accompanied by up to 160 minutes of graded glucose infusion (GGI). During GGI glucose (20% D/W) was gradually infused at rates of 2,4,6 and 10 mg/kg/min, with each rate lasting approximately 40 minutes. Glucose levels were measured from blood collected at baseline and during GGI at the following minutes: 0, 20, 40, 60, 80, 100, 120, 140, 160 and 165 in order to calculate the time-weighted average change from baseline in glucose AUC from 0-160 minutes.|Baseline and during GGI at time points 0, 20, 40, 60, 80, 100, 120, 140, 160 and 165 minutes|Participants treated with Oxyntomodulin or placebo. Six participants were treated for two periods with placebo, resulting in placebo n = 18. Participants treated with Liraglutide were not analyzed for this outcome measure.||mg/dL||Standard Deviation|Least Squares Mean
696817|NCT01373346|Secondary|Albumin : Good Response Group|"At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 – 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as good response group. We analyzed the change of albumin level after operation in good response group for the evaluation of long-term safety."|Before operation, 6 months after operation, Until end of study (on average 14.8 months)|At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 – 21.7 months). Normal FPG level and HbA1c < 6% without any antidiabetic medications were observed in 11 patients (78.6 %). We analyzed the change of albumin level after operation for the evaluation of long-term safety in good responder group.||g/dl||Standard Deviation|Mean
696818|NCT01373346|Secondary|Hemoglobin : Good Response Group|"At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 – 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as good response group. For the evaluation of long-term safety, hemoglobin was measured to determine the degree of anemia and malnutrition in good response group."|Before operation, 6 months after operation, Until end of study (on average 14.8 months)|At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 – 21.7 months). Normal FPG level and HbA1c < 6% without any antidiabetic medications were observed in 11 patients (78.6 %). We analyzed the change of hemoglobin after operation in good responder group for the evaluation of long-term safety.||g/dl||Standard Deviation|Mean
696829|NCT01373346|Secondary|Body Mass Index|"BMI(Body Mass index , kg/㎡) was measured.
BMI was obtained using the following formula:
Weight (kg) / (Height (m) x Height (m))"|Before operation, 6 Months After Operation, Until End of Study(on Average 14.8 Months)|Fifteen patients were enrolled for this study. During the follow-up period, there was one patient, who had poorly differentiated neuroendocrine carcinoma which is one of most aggressive gastric cancer, and died due to recurrence four months after surgery. The patient who died of recurrence was excluded from the efficacy evaluation.||kg/㎡||Standard Deviation|Mean
696820|NCT01373346|Secondary|Body Mass Index : Good Response Group|"At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 – 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as good response group. We analyzed the change of weight change after operation in good response group.
BMI(Body Mass index , kg/㎡) was measured.
BMI was obtained using the following formula:
Weight (kg) / (Height (m) x Height (m))"|Before operation, 6 months after operation, Until end of study (on average 14.8 months)|"At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 – 21.7 months). Normal FPG level and HbA1c < 6% without any antidiabetic medications were observed in 11 patients (78.6 %). We called this group as good responder group. We analyzed the change of weight after operation in good responder group."||kg/㎡||Standard Deviation|Mean
696821|NCT01373346|Secondary|HOMA-B : Good Response Group|"At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 – 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as good response group. We analyzed the change of beta-cell function after operation in good response group. HOMA-B(Homoeostasis model assessment-derived beta-cell function) was measured.
HOMA-B was obtained using the following formula:
225 × 18/fasting insulin(mU/L) × fasting glucose(mg/dL)"|Before operation, 6 months after operation, Until end of study (on average 14.8 months)|"At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 – 21.7 months). Normal FPG level and HbA1c < 6% without any antidiabetic medications were observed in 11 patients (78.6 %). We called this group as good responder group. We analyzed the change of beta cell function after operation in good responder group."||percentage of beta cell function||Standard Deviation|Mean
696822|NCT01373346|Secondary|HOMA-IR : Good Response Group|"At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 – 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as good response group. We analyzed the change of insulin resistance after operation in good response group.
HOMA-IR(Homeostasis model assessment-estimated insulin resistance) was measured.
HOMA-IR was obtained using the following formula:
Glucose(mg/dl) x Insulin/405"|Before operation, 6 months after operation, Until end of study (on average 14.8 months)|"At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 – 21.7 months). Normal FPG level and HbA1c < 6% without any antidiabetic medications were observed in 11 patients (78.6 %). We called this group as good responder group. We analyzed the change of HOMA-IR after operation in good responder group."||units on a scale||Standard Deviation|Mean
696823|NCT01373346|Secondary|QUICKI : Good Response Group|"At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 – 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as good response group. We analyzed the change of insulin sensitivity after operation in good response group. The quantitative insulin sensitivity check index (QUICKI) was measured.
The QUICKI is obtained using the following formula:
1 / (log(fasting insulin µU/mL) + log(fasting glucose mg/dL))"|Before operation, 6 months after operation, Until end of study (on average 14.8 months)|"At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 – 21.7 months). Normal FPG level and HbA1c < 6% without any antidiabetic medications were observed in 11 patients (78.6 %). We called this group as good responder group. We analyzed the change of QUICKI after operation in good responder group."||units on a scale||Standard Deviation|Mean
696824|NCT01373346|Secondary|Matsuda Index : Good Response Group|"At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 – 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications after operation. We called this group as good response group. We analyzed the change of insulin sensitivity after operation in good response group.
The Matsuda index(Insulin Sensitivity Index) was obtained using the following formula:
Matsuda index = 10000/square root of [(fasting glucose × fasting insulin) × (mean glucose × mean insulin during OGTT)]"|Before operation , 6 months after operation, Until end of study (on average 14.8 months)|"At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 – 21.7 months). Normal FPG level and HbA1c < 6% without any antidiabetic medications were observed in 11 patients (78.6 %). We called this group as good responder group. We analyzed the change of insulin sensitivity after operation in good responder group."||units on a scale||Standard Deviation|Mean
696825|NCT01373346|Primary|Operation Related Mortality|Operation related mortality was measured for the evaluation of safety for the operation. Operation related mortality was defined as any complication resulting in the death of the patient within 1 month or during hospitalization after operation.|Until end of study (on average 14.8 months)|All of enrolled patient were included.(N=15)||participants|||Number
696826|NCT01373346|Primary|Albumin|For the evaluation of long-term safety, albumin was measured to determine malnutrition.|Before operation , 6 months after operation, Until end of study (on average 14.8 months)|Fifteen patients were enrolled for this study. During the follow-up period, there was one patient, who had poorly differentiated neuroendocrine carcinoma which is one of most aggressive gastric cancer, and died due to recurrence four months after surgery. The patient who died of recurrence was excluded from the long-term safety evaluation.||g/dl||Standard Deviation|Mean
696827|NCT01373346|Primary|Hemoglobin|For the evaluation of long-term safety, hemoglobin was measured to determine the degree of anemia and malnutrition.|Before operation , 6 months after operation, Until end of study (on average 14.8 months)|Fifteen patients were enrolled for this study. During the follow-up period, there was one patient, who had poorly differentiated neuroendocrine carcinoma which is one of most aggressive gastric cancer, and died due to recurrence four months after surgery. The patient who died of recurrence was excluded from the long-term safety evaluation.||g/dl||Standard Deviation|Mean
696828|NCT01373346|Primary|HbA1c|"For the evaluation of efficacy for the operation, HbA1c(%) was measured serially (preop. 6months after op. until end of study(on average 14.8 months)).
HbA1c is formed in a non-enzymatic glycation pathway by hemoglobin's exposure to plasma glucose and measured by high-performance liquid chromatography (HPLC) The HbA1c was calculated as a ratio to total hemoglobin."|Before operation , 6 months after operation, Until end of study (on average 14.8 months)|Fifteen patients were enrolled for this study. During the follow-up period, there was one patient, who had poorly differentiated neuroendocrine carcinoma which is one of most aggressive gastric cancer, and died due to recurrence four months after surgery. The patient who died of recurrence was excluded from the efficacy evaluation.||percentage of glycated hemoglobin||Standard Deviation|Mean
712146|NCT00193063|Secondary|Overall Survival (OS)|The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death|24 months|||months||95% Confidence Interval|Median
696830|NCT01373346|Secondary|HOMA-B|"HOMA-B(Homoeostasis model assessment-derived beta-cell function) was measured.
HOMA-B was obtained using the following formula:
225 × 18/fasting insulin(mU/L) × fasting glucose(mg/dL)"|Before operation , 6 months after operation, Until end of study (on average 14.8 months)|Fifteen patients were enrolled for this study. During the follow-up period, there was one patient, who had poorly differentiated neuroendocrine carcinoma which is one of most aggressive gastric cancer, and died due to recurrence four months after surgery. The patient who died of recurrence was excluded from the efficacy evaluation.||percentage of beta cell function||Standard Deviation|Mean
696831|NCT01373346|Secondary|HOMA-IR|"HOMA-IR(Homeostasis model assessment-estimated insulin resistance) was measured.
HOMA-IR was obtained using the following formula:
Glucose(mg/dl) x Insulin/405"|Before operation , 6 months after operation, Until end of study (on average 14.8 months)|Fifteen patients were enrolled for this study. During the follow-up period, there was one patient, who had poorly differentiated neuroendocrine carcinoma which is one of most aggressive gastric cancer, and died due to recurrence four months after surgery. The patient who died of recurrence was excluded from the efficacy evaluation.||units on a scale||Standard Deviation|Mean
696832|NCT01373346|Secondary|QUICKI|"The quantitative insulin sensitivity check index (QUICKI) was measured.
The QUICKI was obtained using the following formula:
1 / (log(fasting insulin µU/mL) + log(fasting glucose mg/dL))"|Before operation , 6 months after operation , Until end of study (on average 14.8 months)|Fifteen patients were enrolled for this study. During the follow-up period, there was one patient, who had poorly differentiated neuroendocrine carcinoma which is one of most aggressive gastric cancer, and died due to recurrence four months after surgery. The patient who died of recurrence was excluded from the efficacy evaluation.||units on a scale||Standard Deviation|Mean
696833|NCT01373346|Primary|Morbidity|"For the evaluation of safety, morbidity were analyzed. For the evaluation of short-term safety, complications higher than the Clavien-Dindo grade II (Dindo et. Ann Surg 240:205 2004) were collected.
*Clavien-dindo classification of surgical complications Grade II: Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included.
Grade III: Requiring surgical, endoscopic or radiological intervention Grade IV:Life-threatening complication (including CNS complications)‡ requiring IC/ICU-management Grade V:Death of a patient Suffix'd' : If the patient suffers from a complication at the time of discharge ,the suffix “d” (for ‘disability’) is added to the respective grade of complication. This label indicates the need for a follow-up to fully evaluate the complication.
For the evaluation of long-term safety, the patients were evaluated every month after discharge."|Until end of study (on average 14.8 months)|All of enrolled patient were included. (N=15)||participants|||Number
696834|NCT01373346|Secondary|Matsuda Index|"Matsuda Index(Insulin Sensitivity Index) was measured.
The Matsuda index was obtained using the following formula:
Matsuda index = 10000/square root of [(fasting glucose × fasting insulin) × (mean glucose × mean insulin during OGTT)]"|Before operation , 6 months after operation, Until end of study (on average 14.8 months)|Fifteen patients were enrolled for this study. During the follow-up period, there was one patient, who had poorly differentiated neuroendocrine carcinoma which is one of most aggressive gastric cancer, and died due to recurrence four months after surgery. The patient who died of recurrence was excluded from the efficacy evaluation.||units on a scale||Standard Deviation|Mean
696835|NCT01373294|Other Pre-specified|Comparison of the Correlative Assay|For comparing the correlative assay results of ever-relapsers vs non-relapsers, the combined data with the monotherapy and combination therapy groups would be applied. The participants would be categorized based on 1-year relapse.|1 year post disease response||||||
696836|NCT01373294|Other Pre-specified|Effect of Addition of Revlimid on Cytokines|The immunologic impact of the addition of Revlimid™ to BCG for secondary prevention of non-muscle-invasive transitional cell bladder cancer, in terms of a panel of correlative assays. The effect of addition of Revlimid on cytokines associated with generation of immune response and on cytotoxic T lymphocytes and memory phenotype lymphocytes.|Duration of study treatment and follow-up - average of 12 months||||||
696837|NCT01373294|Secondary|Treatment Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|Number of participants with treatment emergent AEs or SAEs per category. SAEs will be specifically labeled as such. Participants were assessed at monthly intervals (corresponding to Revlimid™ refill points for adverse events), classified by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, and these were tabulated.|Duration of study treatment and follow-up - average of 12 months|All participants.||participants|||Number
696838|NCT01373294|Primary|Arm A: Progression Free Survival (PFS)|The 1-year progression free/ recurrence free/ bladder-intact survival was tabulated for the experimental arm for a median follow-up period of 369 days. The progression free/ recurrence free/ bladder-intact survival is defined as the time from start of study treatment to first documentation of objective tumor progression, recurrence, bladder resection or irradiation or to death due to any cause, whichever comes first. PFS data was not collected for participants in the Arm B: Control because too few participants were enrolled in Arm B to conduct the planned per Arm comparison|1 year|Experimental Arm A Group Only.||participants|||Number
696839|NCT01373281|Primary|Density Incidence of Symptomatic Virologically Confirmed Dengue Cases Due to Any Serotype During the Active Phase Post-dose 3 Injection With CYD Dengue Vaccine|"Symptomatic virologically-confirmed dengue (VCD) cases were defined as acute febrile illness (temperature ≥38°C on at least 2 consecutive days) and confirmed by dengue reverse transcriptase polymerase chain reaction and/or dengue NS1 enzyme-linked immunosorbent assay. Cases defined as number of subjects with at least one symptomatic VCD episode from 28 days post-injection 3 to the end of Active Phase.
Density incidence: data are cases per 100 person-years at risk. Data presented is the sum of individual units of time for which the participants contributed to the analyses. Incidence density was calculated as the number of VCD cases divided by the cumulative person-years at risk."|28 days and up to 14 months post-injection 3|Density incidence of symptomatic virologically confirmed dengue cases were assessed in the Per-Protocol Analysis Set.||Cases per 100 person-year at risk|||Number
696853|NCT01372995|Primary|Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 84|The number of participants with a plasma 25(OH)D concentration in the desirable range (defined as greater than 30 ng/mL) at the Day 84 measurement.|Day 84|Blood samples were obtained every 7 days while participants remained hospitalized. Follow up discontinued once the participant was discharged from the hospital. The number of participants analyzed at each time point decreased over the course of the study as participants were discharged from the hospital.||participants|||Number
696840|NCT01373281|Primary|The Person-years at Risk for Participants With Symptomatic Virologically Confirmed Dengue Cases (Vaccine Efficacy) Due to Any Serotype During the Active Phase Post-dose 3 Injection With CYD Dengue Vaccine|The person-years at risk was the cumulative time (in years) until the participant was diagnosed with VCD or until the end of the active period, whichever came first. Data presented is the sum of individual units of time for which the participants contributed to the analyses. Incidence density was calculated as the number of VCD cases divided by the cumulative person-years at risk. The vaccine efficacy is considered as significant if the lower bound of its 95% CI (exact method by Breslow & Day) is greater than 25%.|28 days and up to 14 months post-injection 3|Vaccine Efficacy Against Symptomatic Virologically confirmed Dengue Cases were assessed in the Per-Protocol Analysis Set.||Cumulative time (in years) until VCD|||Number
696841|NCT01373281|Secondary|Percentage of Subjects With Solicited Injection-site and Systemic Reactions Following Any and Each Injection With CYD Dengue Tetravalent Vaccine|Solicited injection-site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Asthenia. Grade 3 Solicited injection site reactions (2-11 years): Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥50 mm. Grade 3 Solicited injection site reactions (12-14 years): Pain, Significant, prevents daily activity; Erythema and Swelling, >100 mm. Grade 3 Solicited injection site reactions: Fever, ≥39°C; Headache, Malaise, Myalgia, and Asthenia, Significant, prevents daily activity.|Day 0 up to Day 14 post each vaccination|Solicited injection site reactions and systemic reactions were assessed in a subset of the Safety Analysis Set, which includes all persons who received at least one dose of study vaccine.||Percentage of participants|||Number
696842|NCT01373281|Secondary|Percentage of Flavi Virus-Immuned Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine|Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT). Flavi virus (FV) immune participants at baseline are defined as those participants with ≥ 10 1/dil for at least one serotype with the parental dengue virus strain or for Yellow Fever titer.|Pre-vaccination 1 and Day 28 post each vaccination up to 25 months (visit 07)|Antibody titers against each dengue virus serotype strain were assessed in the Per-Protocol Analysis Set for Immunogenicity population, i.e. those who received vaccine 3 doses in the Immunogenicity subset only.||Percentage of participants|||Number
696843|NCT01373281|Secondary|Geometric Mean Titers of Antibodies Against Each Serotype With the Parental Dengue Virus Strain Before and Following Injection With CYD Dengue Tetravalent Vaccine|Geometric mean titers against each serotypes of the Dengue virus strains were assessed using the plaque reduction neutralization test (PRNT) in a pre-defined subset of 2,000 subjects from each country (1,333 in the CYD Dengue Vaccine Group and 667 in the Control Group).|Pre-vaccination 1 and Day 28 post each vaccination up to 25 months (visit 07)|Antibody titers against each dengue virus serotype strain were assessed in a subset of the Full Analysis Set for Immunogenicity (FASI), subjects who received at least one dose of vaccine.||Titers||95% Confidence Interval|Geometric Mean
696844|NCT01373281|Primary|Number of Symptomatic Virologically Confirmed Dengue Cases (Vaccine Efficacy) Due to Any Serotype During the Active Phase Post-dose 3 Injection With CYD Dengue Vaccine|"Symptomatic virologically-confirmed dengue (VCD) cases were defined as acute febrile illness (temperature ≥38°C on at least 2 consecutive days) and confirmed by dengue reverse transcriptase polymerase chain reaction and/or dengue NS1 enzyme-linked immunosorbent assay. Cases defined as number of subjects with at least one symptomatic VCD episode from 28 days post-injection 3 to the end of Active Phase.
The vaccine efficacy is considered as significant if the lower bound of its 95% CI (exact method by Breslow & Day) is greater than 25%."|28 days and up to 13 months post-injection 3|Number of symptomatic virologically confirmed dengue cases were assessed in the Per-Protocol Analysis Set.||Cases per 100 person-years at risk|||Number
696845|NCT01372995|Secondary|Day 84 Mortality|The number of participants who died prior to the end of the study (Day 84) was collected.|Day 84|The number of participants in the hospital mortality analysis for the arm receiving 500,000 IU of Vitamin D3 was 10, rather than 11, as one participant withdrew.||participants|||Number
696846|NCT01372995|Secondary|Number of Hospital Mortality Cases|The number of study participants who died while in the hospital was collected.|12 weeks|The number of participants in the hospital mortality analysis for the arm receiving 500,000 IU of Vitamin D3 was 10, rather than 11.||participants|||Number
696847|NCT01372995|Secondary|Number of Hospital Acquired Infections|The number of study participants who had a hospital acquired infection.|12 weeks|||participants|||Number
696848|NCT01372995|Secondary|Change in Sequential Organ Failure Assessment (SOFA) Score|Change in Sequential Organ Failure Assessment (SOFA) score between Baseline and Day 7. The Sequential Organ Failure Assessment (SOFA) score is a mortality prediction score that is based on the degree of dysfunction of 6 organ systems (respiratory, nervous, cardiovascular, liver, coagulation, and kidneys). A score ranges from 0-24. 0 (normal) to 4 (high degree of dysfunction) is given for each organ system, with a higher score indicating greater severity. A score of 0-6 is associated with a mortality rate of less than 10% while a score between 16 and 24 is associated with a greater than 90% mortality rate. Scores decreasing between the Baseline and Day 7 measurements are represented as negative values for the change in SOFA score.|Baseline, Day 7|SOFA score obtained daily while in the ICU. The portion of the study participants included in the analysis of the change in SOFA score between Baseline and Day 7 is limited to participants having values for both time points..||units on a scale||Standard Deviation|Mean
696849|NCT01372995|Secondary|Duration of Time in Hospital|The number of days that each participant spent in the hospital was collected and the average number of days for each study arm is reported.|12 weeks|||days||Standard Deviation|Mean
696850|NCT01372995|Secondary|Duration of Time in Intensive Care Unit (ICU)|The number of days spent in the intensive care unit (ICU) was collected for each participant and the average number of days for each study arm is reported.|12 weeks|||days||Standard Deviation|Mean
696851|NCT01372995|Secondary|Duration of Time on Ventilator|The number of days spent on mechanical ventilation was collected for all study participants and the average number of days for each study arm is reported.|12 weeks|||days||Standard Deviation|Mean
696852|NCT01372995|Secondary|Change in Plasma LL-37 Levels|Plasma LL-37 was measured at Baseline, Day 7 and Day 14.|Baseline, Day 7, Day 14|For the Day 14 analysis there were 8 participants in the Placebo arm, 6 participants in the 250,000 of Vitamin D arm, and 5 participants in the 500,000 of Vitamin D arm.||ng/mL||Inter-Quartile Range|Median
696854|NCT01372995|Primary|Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 28|The number of participants with a plasma 25(OH)D concentration in the desirable range (defined as greater than 30 ng/mL) at the Day 28 measurement.|Day 28|Blood samples were obtained every 7 days while participants remained hospitalized. Follow up discontinued once the participant was discharged from the hospital. The number of participants analyzed at each time point decreased over the course of the study as participants were discharged from the hospital.||participants|||Number
696855|NCT01372995|Primary|Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 21|The number of participants with a plasma 25(OH)D concentration in the desirable range (defined as greater than 30 ng/mL) at the Day 21 measurement.|Day 21|Blood samples were obtained every 7 days while participants remained hospitalized. Follow up discontinued once the participant was discharged from the hospital. The number of participants analyzed at each time point decreased over the course of the study as participants were discharged from the hospital.||participants|||Number
696856|NCT01372995|Primary|Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 14|The number of participants with a plasma 25(OH)D concentration in the desirable range (defined as greater than 30 ng/mL) at the Day 14 measurement.|Day 14|Blood samples were obtained every 7 days while participants remained hospitalized. Follow up discontinued once the participant was discharged from the hospital. The number of participants analyzed for each time point decreased over the course of the study as participants were discharged from the hospital.||participants|||Number
696857|NCT01372995|Primary|Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 7|The number of participants with a plasma 25(OH)D concentration in the desirable range (defined as greater than 30 ng/mL) at the Day 7 measurement.|Day 7|Blood samples were obtained every 7 days while participants remained hospitalized. Follow up discontinued once the participant was discharged from the hospital. The number of participants analyzed at each time point decreased over the course of the study as participants were discharged from the hospital.||participants|||Number
696858|NCT01372995|Primary|Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Baseline|The number of participants with a plasma 25(OH)D concentration in the desirable range (defined as greater than 30 ng/mL) at the baseline measurement.|Baseline|Blood samples were obtained every 7 days while participants remained hospitalized. Follow up discontinued once the participant was discharged from the hospital. At the baseline time point, 10 patients were randomized to the placebo arm, 9 to the arm receiving 250,000 IU of Vitamin D3, and 11 to the arm receiving 500,000 of Vitamin D3.||participants|||Number
696859|NCT01372878|Secondary|Sensitivity and Specificity of PillCam Platform With the PillCam COLON 2 Capsule in Detecting Patients With Polyps ≥10 mm Where OC Considered as the Gold Standard Reference|Sensitivity and specificity of PillCam Platform with the PillCam COLON 2 capsule in detecting subjects with polyps equal to or larger than 6 mm. For a given polyp, a match between the PillCam Colon 2 Capsule and optical colonoscopy was considered if the polyp size was assessed within plus or minus 50% of the size of the estimate of the OC measurement and the polyp as appearing within the same colon segment or in adjacent segments. The polyp size measurement by optical colonoscopy was used as the reference standard.|1 year, same as study duration|||percentage of participants||95% Confidence Interval|Number
696860|NCT01372878|Primary|Sensitivity and Specificity of PillCam Platform With the PillCam COLON 2 Capsule in Detecting Patients With Polyps ≥6 mm Where OC Considered as the Gold Standard Reference|"Sensitivity and specificity of PillCam Platform with the PillCam COLON 2 capsule in detecting subjects with polyps equal to or larger than 6 mm. For a given polyp, a match between the PillCam Colon 2 Capsule and optical colonoscopy was considered if the polyp size was assessed within plus or minus 50% of the size of the estimate of the OC measurement and the polyp as appearing within the same colon segment or in adjacent segments. The polyp size measurement by optical colonoscopy was used as the reference standard.
Sensitivity measures the proportion of actual positives which are correctly identified as such.
Specificity measures the proportion of negatives which are correctly identified as such.
positive event defined as patients with polyps ≥6 mm detected by OC procedure."|1 year, same as study duration|||percentage of participants||95% Confidence Interval|Number
696861|NCT01372813|Secondary|Evaluate The Correlation Between Von Hippel-Lindau (VHL) Mutational Status and Response to ZD6474 (Vandetanib)|If an adequate number of responses were seen, the relation of these responses to the presence/absence of inactivating VHL mutations in tumor tissue would have been assessed.|12 months|Not enough samples for meaningful analysis.|||||
696862|NCT01372813|Secondary|The Effects of ZD6474 (Vandetanib) on Tumor Microvessel Density|Tumor tissue sections were to be stained with hematoxylin and eosin (H and E) and endothelial cell markers at baseline and specified timepoints following initiation of therapy (when tumor tissue was available)|12 months|Not enough samples for meaningful analysis.|||||
696863|NCT01372813|Secondary|Tumor Tissue Used to Evaluate Von Hippel-Lindau (VHL) Status and/or Components of the Vascular Endothelial Growth Factor (VEGF)/Epidermal Growth Factor Receptor (EGFR) Pathway|Components of the VEGF and EGFR pathways were to be evaluated using Western blot analysis at baseline and specified timepoints following initiation of therapy when tumor tissue was available.|12 months|Not enough samples for meaningful analysis.|||||
696864|NCT01372813|Secondary|Number of Participants With Vandetanib (ZD6474) Effects on Tumor Vascular Flow and Permeability Using Dynamic Contrast Enhanced Magnetic Resonance Imaging (DCE-MRI)|Flow dynamics within specific tumor sites will be evaluated based on the results of the DCE-MRI obtained first without contrast enhancement and then after contrast enhancement. The parameter to be measured is the forward contrast transfer rate (Ktrans), the reverse contrast transfer rate (Kep), and/or the extravascular extracellular space volume fraction (Ve). Flow dynamics are a measure of blood flow changes in the tumor and are determined using the parameters previously defined (Ktrans, Kep, etc.).|12 months|||Participants with changes|||Number
696865|NCT01372813|Secondary|Number of Circulating Endothelial Cells (CEC) Per 10^6 Mononuclear Cells or Per Microliter of Peripheral Blood Analyzed in Samples Taken Before and After Treatment|CEC cell concentrations are calculated as a percentage of the total number of mononuclear cells or as the number of cells/microliter of whole blood after an evaluation of a minimum of 10^5 cellular events, and preferably 10^6 cellular events.|12 months|Not enough samples for meaningful analysis.|||||
696866|NCT01372813|Secondary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|11.5 months|||Participants|||Number
696868|NCT01372813|Secondary|Number of Circulating Endothelial Progenitor Cells (CEP) Per 10^6 Mononuclear Cells or Per Microliter of Peripheral Blood Analyzed in Samples Taken Before and After Treatment|CEP cell concentrations are calculated as a percentage of the total number of mononuclear cells or as the number of cells/microliter of whole blood after an evaluation of a minimum of 10^5 cellular events, and preferably 10^6 cellular events.|12 months|Not enough samples for meaningful analysis.|||||
696869|NCT01372813|Secondary|Effect of Vandetanib on Plasma Biomarkers-vascular Endothelial Growth Factor (VEGF), Vascular Endothelial Growth Factor 2 (VEGFR2)|Plasma VEGFR and VEGFR2 would have been measured using the (enzyme-linked immunosorbent assay)ELISA at baseline and specified timepoints following initiation of therapy.|12 months|Not enough samples for meaningful analysis.|||||
696870|NCT01372813|Primary|Number of Participants With a Clinical Response (Partial Response (PR) + Clinical Response (CR))|Clinical response is the best response recorded from the start of treatment until disease progression. Clinical response is assessed by the Response Evaluation in Solid Tumors (RECIST) criteria. A partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as a reference the baseline sum LD. A complete response (CR) is the disappearance of all target lesions.|12 months|||Participants|||Number
696871|NCT01372748|Secondary|Percentage of Participants Scoring at or Below a 3 on the MRS Scale|Neurologic status at discharge will be assessed using the modified Rankin Score (MRS). A higher value indicates a worse outcome. 0-No symptoms at all; 1-No significant disability despite symptoms; able to carry out all usual duties and activities, 2-Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance, 3-Moderate disability; requiring some help, but able to walk without assistance; 4-Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance, 5-Severe disability; bedridden, incontinent and requiring constant nursing care and attention; 6-Dead|Patients will be followed from the time of the cardiac arrest until death or hospital discharge, whichever occurs first.|||percentage of participants|||Number
696872|NCT01372748|Primary|Number of Participants Who Survive From the Time of Cardiac Arrest to Hospital Discharge|Patients may die in the field (outside of the hospital at the time of the cardiac arrest), at the emergency room, in the hospital, or they are discharged alive from the hospital.|Patients will be followed from the time of the cardiac arrest until death or hospital discharge, whichever occurs first.|The primary aim of the trial is to compare survival to hospital discharge after continuous chest compressions (CCC) versus standard American Heart Association (AHA) recommended cardiopulmonary resuscitation (CPR) with interrupted chest compressions (ICC) in patients with out-of-hospital cardiac arrest (OOHCA).||participants|||Number
696873|NCT01372605|Secondary|Depression-free Days|Total depression-free days over 12 months as calculated from Hamilton Rating Scale for Depression scores at baseline and 3, 6, 9, and 12 months|12 months|All participants with at least one depression measure contributed to this analysis.||days||Standard Deviation|Mean
696874|NCT01372605|Secondary|Safety Endpoint|Psychiatric hospitalizations|12 months|||participants|||Number
696875|NCT01372605|Secondary|Self-reported Adherence|Antiretroviral medication adherence, self-reported, over past 30 days using a visual analog scale. On the scale, participants report the percentage of prescribed antiretroviral pills that were taken in the past 30 days, ranging from 0 (no pills) to 100% (all pills).|12 months|All participants completing the 12-month interview contributed data to this analysis. Some participants did not complete the 12-month interview but still completed the study and contributed other data.||units on a scale||Standard Deviation|Mean
696876|NCT01372605|Secondary|Self Reported Adherence|Antiretroviral medication adherence, self-reported, over past 30 days using a visual analog scale. On the scale, participants report the percentage of prescribed antiretroviral pills that were taken in the past 30 days, ranging from 0 (no pills) to 100% (all pills).|6 months|All participants completing the 6-month interview and currently on antiretrovirals contributed to this analysis. Some participants did not complete the 6-month interview but still continued in the study and contributed to later data.||units on a scale||Standard Deviation|Mean
696877|NCT01372605|Secondary|Quality of Life|Short Form-12 Mental Composite score. Scores range from 0-100, with 50 corresponding to the mean and 10 points to the standard deviation in a normative US population. Higher scores indicate better health.|6 months|All participants who completed a 6-month research interview contributed data to this endpoint. Some participants did not complete the 6-month interview but still continued in the study and contributed later data.||units on a scale||Standard Deviation|Mean
696878|NCT01372605|Secondary|Number of Participants With Viral Load Below Detection|HIV RNA viral load below the limit of detection at 6 months|6 months|All participants with a viral load available at 6 months. Some individuals without a viral load at 6 months still continued in the study and provided later data.||participants|||Number
696879|NCT01372605|Secondary|Appointment Adherence|Kept HIV appointments as a percentage of all kept or missed appointments during 12 months post-enrollment|12 months|All participants with available medical chart data on appointment attendance were analyzed. Some participants did not complete the study but still contributed chart abstraction data.||Percent of appts that were kept||Standard Deviation|Mean
696880|NCT01372605|Secondary|Health Care Costs|Total health care costs over 12 months|12 months|All participants were analyzed using all available time points, with multiple imputation used to address missing data.||dollars||Standard Error|Mean
696881|NCT01372605|Secondary|Antiretroviral Medication Adherence|Antiretroviral medication adherence assessed by unannounced pill count, assessed by blinded assessor|12 months|Includes all individuals who completed a 6-month pill count that could be linked to an earlier (usually, 5-month) pill count, so as to calculate adherence. Some individuals did not complete this data point but still continued in the study and contributed later data.||Percentage of expected pills||Standard Deviation|Mean
696882|NCT01372605|Secondary|Depressive Symptoms|Hamilton Rating Scale for Depression (HAMD) symptom score at 6 months, assessed by blinded assessor. Possible score ranges from 0 to 50. Higher scores indicate worse depressive symptoms.|Six months|All those completing a 6-month outcomes interview which resulted in a valid HAMD measure||units on a scale||Standard Deviation|Mean
696883|NCT01372605|Primary|Antiretroviral Medication Adherence|Antiretroviral medication adherence assessed by monthly unannounced pill count, assessed by blinded assessor|Six months post-enrollment|All those completing a 6-month pill count which resulted in a valid adherence measure||observed pills taken as % of expected||Standard Deviation|Mean
696886|NCT01372462|Secondary|Borg Dyspnea Score During Constant Workrate Exercise at Isotime|"Mean differences between NIOV - oxygen, NIOV - Room Air, Nasal Cannula Oxygen, and no treatment (control) at isotime. Borg Dyspnea Score ranges in values from 0 to 10. The lower score represent better outcome.
0 = No breathlessness at all, representing better outcome 10 = Maximum breathlessness, representing worse outcome"|Outcome was measured in each Study day 1,2,3 and 4. Study days 1,2,3, and 4; Day 1 for no treatment; day 2 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 3 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 4 for NIOV - oxygen and N|Per Protocol||units on a scale||Standard Deviation|Mean
696887|NCT01372462|Secondary|SpO2 During Constant Workrate Exercise at Isotime|Mean differences between NIOV - oxygen, NIOV - Room Air, Nasal Cannula Oxygen, and no treatment (control).|Outcome was measured in each of the Study day 1,2, 3 and 4. Study days 1,2,3, and 4; Day 1 for no treatment; day 2 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 3 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 4 for NIOV - oxyg|Per Protocol||percentage of oxyHb saturation||Standard Deviation|Mean
696888|NCT01372462|Primary|Exercise Duration for Constant Work Rate Exercise Tests Under 4 Test Conditions|Mean differences between NIOV - oxygen, NIOV - Room Air, Nasal Cannula Oxygen, and no treatment (control).|Study days 1,2,3, and 4; Day 1 for no treatment; day 2 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 3 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 4 for NIOV - oxygen and Nasal Cannula Oxygen.|Per protocol analysis||minutes||Standard Deviation|Mean
696889|NCT01372410|Primary|Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) on Day 8 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Treatment Day 8 is defined as the value obtained 24 hours after the morning dose administered on Day 7. Analysis was performed using a mixed model with covariates of mean Baseline, period Baseline, treatment, and period as fixed effects and participant as a random effect. Baseline is the FEV1 value recorded pre-dose on Day 1 of each treatment period, mean Baseline is the mean of the Baselines for each participant, and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each particiapant. Change from Baseline for each treatment period is the trough FEV1 at Day 8 minus the Baseline value for that treatment period.|Baseline and Day 8 of each treatment period (up to Study Day 50)|mITT Population. All participants with >=1 post-baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 8.||Liters||Standard Error|Least Squares Mean
696890|NCT01372410|Primary|Final Dose-response Model Parameter β-FEV1MB-S0 for Trough FEV1|The trough FEV1 data for both the once-daily (QD) and twice-daily (BID) UMEC doses were included in a parametric analysis in order to evaluate dose response. Both a Day 8 dataset and a pooled dataset for Day 7 and Day 8 were analyzed and reported. The rationale for pooling Day 7 and Day 8 (post-hoc analysis) was to ensure informative interpretation of FEV1 response as a function of dose given the repeated measures for trough FEV1 response within each participant on different days. β-FEV1MB-S0 is defined as the covariate (Baseline trough FEV1) effect on the mean Baseline trough FEV1 estimate (S0). FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second.|Day 7 and Day 8 of each treatment period (up to Study Day 50)|mITT Population: par. randomized to treatment who received >=1 dose of study medication. Par. with >=1 post-BL assessment and non-missing covariate data are included in the analysis. Different par. may have been analyzed at different time points (n=X in category titles); the overall number of par. analyzed reflects everyone in the mITT Population.||fraction of mean estimated Baseline FEV1|||Number
696891|NCT01372410|Primary|Final Dose-response Model for Trough FEV1 for ED50 (Potency) Parameter|The trough FEV1 data for both the once-daily (QD) and twice-daily (BID) UMEC doses were included in a parametric analysis in order to evaluate dose response. Both a Day 8 dataset and a pooled dataset for Day 7 and Day 8 were analyzed and reported. The rationale for pooling Day 7 and Day 8 (post-hoc analysis) was to ensure informative interpretation of FEV1 response as a function of dose given the repeated measures for trough FEV1 response within each participant on different days. ED50 is defined as the potency and is the dose that yields 50% of Emax (maximum predicted FEV1 response). FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second.|Day 7 and Day 8 of each treatment period (up to Study Day 50)|mITT Population: par. randomized to treatment who received >=1 dose of study medication. Par. with >=1 post-BL assessment and non-missing covariate data are included in the analysis. Different par. may have been analyzed at different time points (n=X in category titles); the overall number of par. analyzed reflects everyone in the mITT Population.||micrograms||95% Confidence Interval|Geometric Mean
696892|NCT01372410|Secondary|Change From Baseline (BL) in Weighted Mean FEV1 Over 0 to 24 Hours After the Morning Dosing on Day 7 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The weighted mean FEV1 was derived by calculating the area under the FEV1/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. The weighted mean FEV1 was calculated using 0-24 hour post-dose measurements at Day 7 of each treatment period, which included pre-dose and post-dose 1, 3, 6, 9, 12, 13, 15, 23, and 24 hours. Analysis was performed using a mixed model with covariates of mean BL, period BL, treatment, and period as fixed effects and participant as a random effect. BL is the FEV1 value recorded pre-dose on Day 1 of each TP, mean BL is the mean of the BLs for each participant, and period BL is the difference between the BL and the mean BL in each TP for each participant. Change from BL for each TP is the weighted mean FEV1 at Day 7 minus the BL value for that TP.|Baseline and Day 7 of each treatment period (TP; up to Study Day 49)|mITT Population. All participants with >=1 post-Baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 7.||Liters||Standard Error|Least Squares Mean
696904|NCT01372150|Secondary|Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8|A 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Baseline and Weeks 1, 2, 3, 4, 6, and 8|ITT Population||Percentage of Participants|||Number
698218|NCT01358864|Secondary|Early Treatment Success (ETS)|Percentage of participants with early Treatment Success (ETS) defined as a plasma HCV RNA level <25 IU/mL (undetected or detected) at Week 4 and <25 IU/mL (undetected) at Week 8.|Week 4 and Week 8|FAS||percentage of participants|||Number
696893|NCT01372410|Secondary|Change From Baseline (BL) in Serial FEV1 Over Time on Day 7 of Each Treatment Period|Serial FEV1 for once daily dosing is recorded at the pre-AM dose (AMD; time 0 hour [h]) and at 1, 3, 6, 9, 12,13, 15, 23, and 24 hours after the AMD on Day 7. For twice daily dosing, the 12 h AMD corresponds to the pre-PM dose (PMD), the 13 h AMD corresponds to the 1 h PMD, the 15 h AMD corresponds to the 3 h PMD, the 23 h AMD corresponds to the 11 h PMD, and the 24 h AMD corresponds to the 12 h PMD in this table. Analysis was performed using a mixed model with covariates of mean BL, period BL, treatment, period, time, time by period BL interaction, time by mean BL interaction, and time by treatment interaction as fixed effects and participant as a random effect. BL is the value recorded pre-dose on Day 1 of each TP, mean BLis the mean of the BLs for each participant, and period BL is the difference between the BL and the mean BL in each TP for each participant. Change from BL for each timepoint within a TP is the serial FEV1 measure at that timepoint minus the BL value for that TP.|Baseline and Day 7 of each treatment period (TP; up to Study Day 49)|mITT Population. All participants (par.) with >=1 post-BL assessment and non-missing covariate data are included in the analysis. Different par. may have been analyzed at different time points (n=X, X, X, X in the category titles), so the overall number of par. analyzed reflects everyone in the mITT Population with data available at >=1 time point.||Liters||Standard Error|Least Squares Mean
696894|NCT01372410|Primary|Final Dose-response Model for Trough Forced Expiratory Volume in One Second (FEV1)|The trough FEV1 data for both the once-daily (QD) and twice-daily (BID) UMEC doses were included in a parametric analysis in order to evaluate trough FEV1dose response. The Day 8 dataset and a pooled dataset for Day 7 and Day 8 were analyzed separately and reported. The rationale for pooling Day 7 and Day 8 (post-hoc analysis) was to ensure informative interpretation of FEV1 response as a function of dose given the repeated measures for trough FEV1 response within each participant on different days. The fixed-effects parameters of the dose response model include Emax (the maximum predicted FEV1 response), ED50 (potency), and S0 (estimated Baseline FEV1). FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Data for Emax and S0 are reported in this table. mITT=Modified Intent-to-Treat; par.=participants; BL=Baseline.|Day 7 and Day 8 of each treatment period (up to Study Day 50)|mITT Population: par. randomized to treatment who received >=1 dose of study medication. Par. with >=1 post-BL assessment and non-missing covariate data are included in the analysis. Different par. may have been analyzed at different time points (n=X in category titles); the overall number of par. analyzed reflects everyone in the mITT Population.||Liters||95% Confidence Interval|Geometric Mean
696895|NCT01372384|Secondary|Overall Survival|The overall survival (OS) is defined as the time from the first dose of Erlotinib to the date of death due to any cause.|Until participants had disease progression, unacceptable toxicity, or died; approximately 24 months.|The ITT population included all patients with at least one valid post-baseline assessment.||Days||Full Range|Median
696896|NCT01372384|Secondary|Safety: Incidence of Adverse Events|An AE is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. An SAE is any experience that suggests a significant hazard, contraindication, side effect, or precaution.|Until participants had disease progression, unacceptable toxicity, or died; approximately 24 months.|All participants who received at least one dose of study medication and had a safety assessment performed post baseline were included in the safety population. Participants were analyzed according to the first dose received during the study.||participants|||Number
696897|NCT01372384|Secondary|Objective Response Rate (Investigator Assessed)|Objective response rate (ORR) was defined by RECIST criteria: Partial response (PR) was defined as ≥ 30% decrease in the sum of longest diameter of all target lesions, from the baseline sum. Complete response (CR) was defined as disappearance of all target and non-target lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments within 4 weeks. Progression of disease (PD) = 20% increase in the sum of longest diameter of all target lesions, from smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions. Stable Disease (SD) = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on the study.|Visit 4, Visit 6, Visit 10 and Visit 22; (up to approximately 24 months)|The ITT population included all patients with at least one valid post-baseline assessment. Only those participants available at the specified time points were analyzed (represented by n=X).||Percentage||95% Confidence Interval|Number
696898|NCT01372384|Primary|Progression-free Survival (Tumour Assessments According to RECIST Criteria)|Progression free survival is (PFS) defined as the time from the first dose of Erlotinib to the date of first occurrence of disease progression or death.|Until participants had disease progression, unacceptable toxicity or died; approximately 24 months.|The Intent-to-treat (ITT population) included all patients with at least one valid post-baseline assessment.||Days||Inter-Quartile Range|Median
696899|NCT01372202|Secondary|Esophageal Tumor CHFR Methylation and Detection in Plasma|To determine the agreement between tumor CHFR methylation and detection in plasma.|3 years||||||
696900|NCT01372202|Secondary|Time to Disease Progression|To determine time to disease progression with this treatment strategy.|3 years||||||
696901|NCT01372202|Secondary|Survival|To determine the survival outcome with this treatment strategy.|3 years||||||
696902|NCT01372202|Primary|Pathological Complete Response|CHFR methylation status correlates with response to taxane containing platinum-based combination therapy and tumor response involving operable Esophageal Cancer. Perform analysis comparing detection of CHFR in tumor and plasma.|3 years|||Participants|||Count of Participants
696903|NCT01372150|Secondary|Percentage of Participants With a CGI-I Response Defined as a Score of 'Very Much Improved' or 'Much Improved'|A 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Weeks 1, 2, 3, 4, 6, and 8|ITT Population||Percentage of Participants|||Number
697314|NCT01368081|Primary|Number of Patients With Drug Related Adverse Events|Number of Patients With Drug Related Adverse Events after the first drug intake until 7 days after the last treatment administration, up to 383 days|After the first drug intake until 7 days after the last treatment administration, up to 383 days|Treated patients||participants|||Number
696905|NCT01372150|Secondary|Change From Baseline to Week 8 in the Clinical Global Impression of Severity (CGI-S) Score|A 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Change: score at observation minus score at baseline. Adjusted mean presented.|Baseline and Week 8|ITT Population||Score on a Scale||Standard Error|Mean
696906|NCT01372150|Primary|Change From Baseline to Week 8 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score|Clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment. Adjusted mean presented.|Baseline and Week 8|Intention-To-Treat (ITT) Population - included all randomized participants who received at least 1 dose of study drug, had a baseline primary efficacy assessment, and had at least one post-baseline primary efficacy assessment.||Score on a Scale||Standard Error|Mean
696907|NCT01371994|Secondary|Time From Baseline to First Day of Returning to Work|The time from Baseline to first day of returning to work was estimated using the Kaplan-Meier method.|From Baseline to Week 12|Full analysis set participants who were employed prior to the study.||days||95% Confidence Interval|Median
696908|NCT01371994|Secondary|Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment|Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent activity impairment is derived from the participant’s assessment of the degree to which their urinary leakage affected their regular daily activities. A higher percentage indicates greater impairment and less productivity. A negative change from Baseline indicates improvement.|Baseline and Week 12|"Full analysis set with available WPAI data at both Baseline and each time point; n indicates the number of participants with available data at each time point."||Percent activity impairment||Standard Error|Least Squares Mean
696909|NCT01371994|Secondary|Baseline Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment|Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent activity impairment is derived from the participant's assessment of the degree to which their urinary leakage affected their regular daily activities. A higher percentage indicates greater impairment and less productivity.|Baseline|Full analysis set participants with available WPAI data at Baseline.||percent activity impairment||Standard Deviation|Mean
696910|NCT01371994|Secondary|Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment|Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent overall work impairment takes into account both hours missed due to urinary leakage and the participant’s assessment of the degree to which urinary leakage affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from Baseline indicates improvement.|Baseline and Week 12|"Full analysis set including participants who were employed prior to the study and with available WPAI data at both Baseline and each time point; n indicates the number of participants with available data at each time point."||percent overall work impairment||Standard Error|Least Squares Mean
696911|NCT01371994|Secondary|Baseline Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment|Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent overall work impairment takes into account both hours missed due to urinary leakage and the participant's assessment of the degree to which urinary leakage affected their productivity while working. A higher percentage indicates greater impairment and less productivity.|Baseline|Full analysis set participants who were employed prior to the study and with available WPAI data at Baseline.||percent overall work impairment||Standard Deviation|Mean
696912|NCT01371994|Secondary|Change From Baseline in Work Productivity Assessment Index (WPAI): Percent Impairment While Working|Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent impairment while working was derived from the participant’s assessment of the degree to which urinary leakage affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from Baseline indicates improvement.|Baseline and Week 12|"Full analysis set including participants who were employed prior to the study and with available WPAI data at both Baseline and each time point; n indicates the number of participants with available data at each time point."||percent impairment while working||Standard Error|Least Squares Mean
696913|NCT01371994|Secondary|Baseline Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working|Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent impairment while working was derived from the participant's assessment of the degree to which urinary leakage affected their productivity while working. A higher percentage indicates greater impairment and less productivity.|Baseline|Full analysis set participants who were employed prior to the study and with available WPAI data at Baseline.||percent impairment while working||Standard Deviation|Mean
696938|NCT01371838|Secondary|Per-Pathogen Microbiological Response at Test of Cure (TOC) Visit by Pathogen in ME Population||7-20 days after last dose of study drug|ME population: includes patients who meet criteria for both the CE and mMITT populations. In fact, there were different pathogens isolated and we decided to focus on the 5 ones that occurred the most. Additionally please be informed that patients number will not match even if we present all 18 pathogens due to polymicrobial infections.||Participants|||Number
696914|NCT01371994|Secondary|Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed|Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent work time missed is derived from the number of hours of work missed due to urinary leakage as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed. A negative change from Baseline indicates improvement.|Baseline and Week 12|"Full analysis set including participants who were employed prior to the study and with available WPAI data at both Baseline and each time point; n indicates the number of participants with available data at each time point."||Percent work time missed||Standard Error|Least Squares Mean
696915|NCT01371994|Secondary|Baseline Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed|Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent work time missed is derived from the number of hours of work missed due to urinary leakage as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed.|Baseline|Full analysis set participants who were employed prior to the study and with available WPAI data at Baseline.||percent work time missed||Standard Deviation|Mean
696916|NCT01371994|Secondary|Change From Baseline in International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) QOL Score|The ICIQ-SF is a validated self-administered questionnaire designed for patients with urinary incontinence. The ICIQ-SF assessed urinary incontinence using 3 scored questions which ask patients about their frequency of urine leakage, how much urine leakage, and perceived impact of leakage on daily lives over the past 4 weeks. The ICIQ-SF is a sum of the 3 scores and ranges from 0 (low bother) to 21 (maximum bother).|Baseline and Week 12|"Full analysis set with available ICIQ-SF data at both Baseline and each time point; n indicates the number of participants with available data at each time point."||units on a scale||Standard Error|Least Squares Mean
696917|NCT01371994|Secondary|International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) QOL Score at Baseline|The ICIQ-SF is a validated self-administered questionnaire designed for patients with urinary incontinence. The ICIQ-SF assessed urinary incontinence using 3 scored questions which ask patients about their frequency of urine leakage, how much urine leakage, and perceived impact of leakage on daily lives over the past 4 weeks. The ICIQ-SF is a sum of the 3 scores and ranges from 0 (low bother) to 21 (maximum bother).|Baseline|Full analysis set with available ICIQ-SF QOL data at Baseline.||units on a scale||Standard Deviation|Mean
696918|NCT01371994|Secondary|Change From Baseline in American Urology Association Quality of Life (QOL) Score|"The American Urology Association (AUA) includes a single bother question which asked participants how they would feel if they had to live with their urinary condition the way it is now for the rest of their life. The bother question score ranges from 0 (delighted) to 6 (terrible).
End of treatment is the last on-treatment assessment during the treatment period."|Baseline and Week 12|"Full analysis set with available AUA data at both Baseline and each time point; n indicates the number of participants with available data at each time point."||units on a scale||Standard Error|Least Squares Mean
696919|NCT01371994|Secondary|American Urology Association Quality of Life (QOL) Score at Baseline|The American Urology Association (AUA) includes a single bother question which asked participants how they would feel if they had to live with their urinary condition the way it is now for the rest of their life. The bother question score ranges from 0 (delighted) to 6 (terrible).|Baseline|Full analysis set with available AUA QOL data at Baseline.||units on a scale||Standard Deviation|Mean
696920|NCT01371994|Secondary|Change From Baseline in American Urology Association Symptom Score (AUASS)|"Quality of life was measured by the American Urology Association Symptom Score (AUASS). The AUASS includes 7 questions addressing symptoms of frequency, urgency, nocturia (waking during the night to urinate), hesitancy, weak urinary, incomplete emptying, and intermittence. The questionnaire asked participants to consider how these symptoms affected them over the past month on a scale from 0 (not at all) to 5 (almost always).
The AUASS Symptom Score is a sum of the 7 symptom scores and ranges from 0 (best) to 35 (worst).
End of treatment is the last on-treatment assessment during the treatment period."|Baseline and Week 12|"Full analysis set with available AUASS data at both Baseline and each time point; n indicates the number of participants with available data at each time point."||units on a scale||Standard Error|Least Squares Mean
696921|NCT01371994|Secondary|American Urology Association Symptom Score (AUASS) at Baseline|"Quality of life was measured by the American Urology Association Symptom Score (AUASS). The AUASS includes 7 questions addressing symptoms of frequency, urgency, nocturia (waking during the night to urinate), hesitancy, weak urinary, incomplete emptying, and intermittence. The questionnaire asked participants to consider how these symptoms affected them over the past month on a scale from 0 (not at all) to 5 (almost always).
The AUASS is a sum of the 7 symptom scores and ranges from 0 (best) to 35 (worst)."|Baseline|Full analysis set with available AUASS data at Baseline.||units on a scale||Standard Deviation|Mean
696922|NCT01371994|Secondary|Change From Baseline in Average Daily Pad Usage|"Participants recorded their daily pad usage in an electronic diary during the 12-week treatment period. A 7-day window was used to calculate the average daily pad usage.
End of treatment is the last on-treatment assessment during the treatment period."|Baseline and Weeks 4, 8 and 12|"Full analysis set with available pad usage data at both Baseline and each time point; n indicates the number of participants with available data at each time point."||pads||Standard Error|Least Squares Mean
696923|NCT01371994|Secondary|Average Daily Pad Usage at Baseline|Participants recorded their daily pad usage in an electronic diary during the 12-week treatment period. A 7-day window was used to calculate the average daily pad usage.|Baseline (7 days prior to Day 1)|Full analysis set with available pad usage data at Baseline.||pads||Standard Deviation|Mean
696924|NCT01371994|Secondary|Percentage of Participants Who Gain Continence During 12-week Treatment Period|"Urinary continence is defined as three consecutive 24-hour days in which a participant uses no pads or a pad for security which remains completely dry. Participants recorded their daily pad usage in an electronic diary during the 12-week treatment period.
End of treatment is the last on-treatment assessment during the treatment period."|Weeks 4, 8, and 12|Full analysis set; the calculation of percentage of participants uses the full analysis set as the denominator at each time point.||percentage of participants|||Number
696925|NCT01371994|Primary|Time From First Dose to Urinary Continence|Urinary continence is defined as the first of three consecutive 24-hour days in which a participant uses no pads, or a pad for security which remains completely dry, during the 12-week treatment period. Participants recorded their daily pad usage in an electronic diary. Kaplan-Meier curves were used to estimate the distribution of cumulative incidence of urinary continence over the 12-week study treatment period. Participants who did not experience the event during the 12-week treatment period were considered as censored at the End of Treatment (EOT) visit or Week 12, whichever occurs first.|12 weeks|Full analysis set defined as all randomized participants who took at least one dose of study drug and had at least one efficacy endpoint evaluation.||days||95% Confidence Interval|Median
696926|NCT01371877|Secondary|Number of Participants With Adverse Events|Unit of Measure is Safety and Tolerability. The number of participants with adverse events will be compared between the groups using the independent sample t-test (assuming the distribution is normal).|3 month study trial|No significant adverse events. All subjects in the high vitamin D3 group completed the study; 4 subjects in the low vitamin D3 600 IU/day withdrew from the study (1 for pregnancy and 3 unknown). There was no evidence of hypercalcemia.||participants|||Number
696927|NCT01371877|Secondary|Total Urticaria Severity Score at 3 Months|The Unit of Measure is Efficacy. The Total Urticaria Severity Score (USS) ranges from 0 to 93, higher scores = worse symptoms. This secondary outcome of this study is to determine if high dose vitamin D supplementation improves the urticaria severity score (USS). The change in USS will be compared between the groups using the independent sample t-test (assuming the distribution is normal). Logistic regression and multiple linear regression will be used to adjust for possible confounders.|3 month intervention|||units on a scale||Standard Error|Mean
696928|NCT01371877|Primary|Medication Usage|The Unit of Measure is Efficacy. The primary outcome of this study is to determine if vitamin D supplementation reduces the medication usage in subjects with CUA. Thus, for the outcome of reduction in pills, at 12 weeks, subjects whose pill usage decreases by 2 or more pills per day will be classified as improved. Subjects whose pill consumption did not change or increased will be classified as unchanged.|12 week intervention|||number of pills/day||Standard Deviation|Mean
696929|NCT01371851|Primary|Change in Psychostimulant-positive Urines Over Time|Urine samples positive for methamphetamine or cocaine via twice-weekly urine drug screens. Weekly urine results data were averaged within subjects and the mean proportion across subjects within each group was calculated for graphic representation.|twice-weekly urine samples (8 weeks)|Those eligible participants who received at least one dose of study medication.||proportion of psychostimulant-pos urines|Participants|Standard Deviation|Mean
696930|NCT01371838|Secondary|Microbiological Re-infection/Recurrence at LFU Visit in ME Population||21-42 days after last dose of study drug|ME population: The ME population includes patients who meet criteria for both the CE and mMITT populations||Participants|||Number
696931|NCT01371838|Secondary|Microbiological Re-infection/Recurrence at LFU Visit in mMITT Population||21-42 days after last dose of study drug|mMITT population: All subjects in MITT population who meet the minimal disease criteria for CABP and who have at least one typical bacterial organism consistent with a CABP pathogen identified from an appropriate microbiological specimen (eg, blood, sputum, or pleural fluid).||Participants|||Number
696932|NCT01371838|Secondary|Clinical Relapse at the LFU Visit for Clinical Cure Patients at Test of Cure (TOC) Visit in CE Population||21-42 days after last day of study drug administration|CE population: All patients in the MITT population who also meet the minimal disease criteria for CABP and for whom sufficient information regarding CABP is available to determine the patient’s outcome (ie, the patient does not have an indeterminate outcome). For this measure only patients who were cured at TOC could be assessed for relapse.||Participants|||Number
696933|NCT01371838|Secondary|Clinical Relapse at the LFU Visit for Clinical Cure Patients at Test of Cure (TOC) Visit in MITT Population||21-42 days after last day of study drug administration|All randomized subjects who were intended to receive study treatment and were of PORT risk class III and IV. For this measure only patients who were cured at TOC could be assessed for relapse.||Participants|||Number
696934|NCT01371838|Secondary|Overall (Clinical and Radiographic) Success Rate at Test of Cure (TOC) Visit in CE Population||7-20 days after last dose of study drug|CE population: All patients in the MITT population who also meet the minimal disease criteria for CABP and for whom sufficient information regarding CABP is available to determine the patient’s outcome (ie, the patient does not have an indeterminate outcome).||Participants|||Number
696935|NCT01371838|Secondary|Overall (Clinical and Radiographic) Success Rate at Test of Cure (TOC) Visit in MITT Population||7-20 days after last day of study drug administration|All randomized subjects who were intended to receive study treatment and were of PORT risk class III and IV.||Participants|||Number
696936|NCT01371838|Secondary|Per-Patient Microbiological Response at Test of Cure (TOC) Visit in ME Population|An outcome is considered as favourable if the per-pathogen response for that subject is either Eradication (An adequate source specimen demonstrates absence of the original baseline pathogen) or presumed eradication (An adequate source specimen was not available to culture and the patient was assessed as a clinical cure). Here, an adequate source specimen is defined as any sample that may yield the growth of a CABP pathogen eg, blood, respiratory specimens, or pleural fluid.|7-20 days after last day of study drug administration|ME population: The ME population includes patients who meet criteria for both the CE and mMITT populations.||Participants|||Number
696937|NCT01371838|Secondary|Per-Patient Microbiological Response at Test of Cure (TOC) Visit in mMITT Population|An outcome is considered as favourable if the per-pathogen response for that subject is either Eradication (An adequate source specimen demonstrates absence of the original baseline pathogen) or presumed eradication (An adequate source specimen was not available to culture and the patient was assessed as a clinical cure). Here, an adequate source specimen is defined as any sample that may yield the growth of a CABP pathogen eg, blood, respiratory specimens, or pleural fluid.|7-20 days after last day of study drug administration|mMITT population: All subjects in MITT population who meet the minimal disease criteria for CABP and who have at least one typical bacterial organism consistent with a CABP pathogen identified from an appropriate microbiological specimen (eg, blood, sputum, or pleural fluid).||Participants|||Number
696994|NCT01371565|Primary|Number of Participants With Adverse Events|Safety was assessed at all visits and adverse events were recorded.|6 months|Due to the small number of patients enrolled (N=4), no formal assessments were planned. All patients who received study drug were included in the safety review.||participants|||Number
696939|NCT01371838|Secondary|Clinical Response at Test of Cure (TOC) Visit by Pathogen in ME Population||7-20 days after last dose of study drug|ME population: includes patients who meet criteria for both the CE and mMITT populations. In fact, there were different pathogens isolated and we decided to focus on the 5 ones that occurred the most. Additionally please be informed that patients number will not match even if we present all 18 pathogens due to polymicrobial infections.||Participants|||Number
696940|NCT01371838|Secondary|Clinical Response at the Test of Cure (TOC) Visit in ME Population||7-20 days after last day of study drug administration|ME population: The ME population includes patients who meet criteria for both the CE and mMITT populations.||Participants|||Number
696941|NCT01371838|Secondary|Clinical Response at the Test of Cure (TOC) Visit in mMITT Population||7-20 days after last day of study drug administration|mMITT population: All subjects in MITT population who meet the minimal disease criteria for CABP and who have at least one typical bacterial organism consistent with a CABP pathogen identified from an appropriate microbiological specimen (eg, blood, sputum, or pleural fluid).||Participants|||Number
696942|NCT01371838|Secondary|Clinical Response at the Test of Cure (TOC) Visit in MITT Population||7-20 days after last day of study drug administration|All randomized subjects who were intended to receive study treatment and were of PORT risk class III and IV.||Participants|||Number
696943|NCT01371838|Secondary|Clinical Response at End of Treatment (EOT) Visit in CE Population||Last day of study drug administration|CE population: All patients in the MITT population who also meet the minimal disease criteria for CABP and for whom sufficient information regarding CABP is available to determine the patient’s outcome (ie, the patient does not have an indeterminate outcome).||Participants|||Number
696944|NCT01371838|Secondary|Clinical Response at End of Treatment (EOT) Visit in MITT Population||Last day of study drug administration|All randomized subjects who were intended to receive study treatment and were of PORT risk class III and IV.||Participants|||Number
696945|NCT01371838|Primary|Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at Test of Cure (TOC) in CE Population|Cure:Total resolution of all signs and symptoms of pneumonia (ie,CABP), or improvement to such an extent that further antimicrobial therapy was not necessary Failure: Any of the following: •Persistence, incomplete clinical resolution, or worsening in signs and symptoms of CABP that required alternative antimicrobial therapy •Treatment-limiting AE leading to discontinuation of study drug therapy, when subject required alternative antimicrobial therapy to treat the pneumonia •Death wherein pneumonia (ie,CABP) was considered causative Indeterminate: Inability to determine an outcome|7-20 days after last dose of study drug|CE population: All patients in the MITT population who also meet the minimal disease criteria for CABP and for whom sufficient information regarding CABP is available to determine the patient’s outcome (ie, the patient does not have an indeterminate outcome).||Participants|||Number
696946|NCT01371825|Secondary|Percentage of Subjects Achieving Transfusion-free Hemoglobin Normalization|The percentage of subjects achieving transfusion-free hemoglobin normalization (TFHN) of ≥ 4 weeks at any time during the study (also referred to as short-term TFHN), and the percentage of subjects who maintained TFHN for ≥ 13 weeks beginning at Week 6 (also referred to as sustained early TFHN). A subject was considered to have achieved short-term TFHN if the/she had two post-baseline measurements of hemoglobin, obtained at least 4 weeks apart, that were above the age-adjusted lower limit of normal (LLN), and had no additional hemoglobin measurements below LLN during this minimum 4-week period and no transfusions administered during the minimum 4-week period or for 2 weeks prior to the start of this period.|from week 0 to data cut-off (27 to 164 weeks of treatment)|Subjects in the Primary Efficacy Analysis Set (PES) who received treatment with sebelipase alfa for at least 4 weeks (and could therefore be assessed for short-term TFHN). The PES included subjects who received any amount of sebelipase alfa and who were ≤ 8 months of age on the date of their first infusion of sebelipase alfa.||percentage of subjects|||Number
696947|NCT01371825|Secondary|Change in Serum Ferritin|Change from baseline in serum ferritin|from week 0 to week 1|Subjects in the Primary Efficacy Analysis Set (PES) with available data at both baseline and week 1. The PES included subjects who received any amount of sebelipase alfa and who were ≤ 8 months of age on the date of their first infusion of sebelipase alfa.||change from baseline (µg/L)||Full Range|Median
696948|NCT01371825|Secondary|Changes in Serum Transaminases|Change from baseline for alanine aminotransferase (ALT) and aspartate aminotransferase (AST)|from week 0 to weeks 1 and 4|Subjects in the Primary Efficacy Analysis Set (PES) with available data at both baseline and week 1 (or week 4). The PES included subjects who received any amount of sebelipase alfa and who were ≤ 8 months of age on the date of their first infusion of sebelipase alfa.||Change from baseline (U/L)||Full Range|Median
696949|NCT01371825|Secondary|Dichotomous Growth Status Indicators|The percentages of subjects meeting criteria for each dichotomous indicator of under nutrition, i.e., underweight (at least 2 SD below median for weight-for-age [WFA]), wasting (at least 2 SD below median for weight-for-length or -height [WFL/WFH]), and stunting (at least 2 SD below median for length- or height-for-age [LFA/HFA])|Month 12 of treatment|Subjects in the Primary Efficacy Analysis Set (PES) with available anthropometric data at Month 12 of treatment as of the data cut-off date (10 June 2014). The PES included subjects who received any amount of sebelipase alfa and who were ≤ 8 months of age on the date of their first infusion of sebelipase alfa.||percentage of subjects|||Number
696950|NCT01371825|Secondary|Effect on Growth Parameters (Weight-for-age)|Changes from baseline in percentiles for weight-for-age (WFA)|from week 0 to data cut-off (27 to 164 weeks of treatment)|Subjects in the Primary Efficacy Analysis Set (PES) who had growth failure at baseline and who survived beyond week 4 of treatment. The PES included subjects who received any amount of sebelipase alfa and who were ≤ 8 months of age on the date of their first infusion of sebelipase alfa.||subjects|||Number
696951|NCT01371825|Secondary|Median Age at Death||from week 0 to data cut-off (27 to 164 weeks of treatment)|Subjects in the Primary Efficacy Ananlysis Set (PES) who died. The PES included subjects who received any amount of sebelipase alfa and who were ≤ 8 months of age on the date of their first infusion of sebelipase alfa.||months||Full Range|Median
696952|NCT01371825|Secondary|Percentage of Subjects in the PES Surviving at 24 Months of Age|The percentage of subjects in the Primary Efficacy Analysis Set (PES) who survived to at least 24 months of age.|from week 0 to data cut-off (27 to 164 weeks of treatment)|Evaluable subjects in the Primary Efficacy Analysis Set (PES), which included subjects who received any amount of sebelipase alfa and who were ≤ 8 months of age on the date of their first infusion of sebelipase alfa. Non-evaluable subjects (n=4) were defined as subjects who were alive, still in the study, and had not yet reached 24 months of age.||percentage of subjects|||Number
696953|NCT01371825|Secondary|Percentage of Subjects in the PES Surviving at 18 Months of Age|The percentage of subjects in the Primary Efficacy Analysis Set (PES) who survived to at least 18 months of age.|from week 0 to data cut-off (27 to 164 weeks of treatment)|Evaluable subjects in the Primary Efficacy Analysis Set (PES), which included subjects who received any amount of sebelipase alfa and who were ≤ 8 months of age on the date of their first infusion of sebelipase alfa. Non-evaluable subjects (n=3) were defined as subjects who were alive, still in the study, and had not yet reached 18 months of age.||percentage of subjects|||Number
696954|NCT01371825|Primary|Percentage of Subjects in the PES Surviving to 12 Months of Age|The primary efficacy endpoint was the percentage of subjects (%) in the Primary Efficacy Analysis Set (PES) who survived to at least 12 months of age.|From week 0 to data cut-off (27 to 164 weeks of treatment)|Evaluable subjects in the Primary Efficacy Analysis Set (PES), which included subjects who received any amount of sebelipase alfa and who were ≤ 8 months of age on the date of their first infusion of sebelipase alfa. All 9 subjects were evaluable.||% of subjects||95% Confidence Interval|Number
696955|NCT01371786|Secondary|Deposition of Radioactivity Within on Nasal Wipes Over 10 Minutes as a Percent of Delivered Dose|The scintigraphic measure of radioactivity deposited on nasal wipes, expressed as a percent of the delivered dose (i.e., the total amount of radioactivity delivered), over 10 minutes (at approximately 2 minute intervals post-dose) following nasal inhalation of a ciclesonide radiolabeled solution via a novel nasal MDI and a mometasone radiolabeled suspension via an aqueous nasal spray.|Average of 2, 4, 6, 8, and 10 minutes post dose|Scinitigraphic Population||percentage of radiolabeled||Standard Deviation|Mean
696956|NCT01371786|Secondary|Initial Deposition of Radioactivity on Nasal Wipes as a Percent of Delivered Dose|The scintigraphic measure of radioactivity initially deposited (approximately 2 minutes post-dose) on nasal wipes, expressed as a percent of the delivered dose (i.e., the total amount of radioactivity delivered), following nasal inhalation of a ciclesonide radiolabeled solution via a novel nasal MDI and a mometasone radiolabeled suspension via an aqueous nasal spray.|Day 1 at 2 minutes post-dose|Scintigraphic Population||percentage of radiolabeled||Standard Deviation|Mean
696957|NCT01371786|Secondary|Deposition of Radioactivity Within the Nasal Cavity Over 10 Minutes as a Percent of Delivered Dose|The scintigraphic measure of radioactivity deposited within the nasal cavity, expressed as a percent of the delivered dose (i.e., the total amount of radioactivity delivered), over 10 minutes (at approximately 2 minute intervals post-dose) following nasal inhalation of a ciclesonide radiolabeled solution via a novel nasal MDI and a mometasone radiolabeled suspension via an aqueous nasal spray.|Average of 2, 4, 6, 8 and 10 minutes post dose|Scinitgraphic Population||percentage of of radiolabled||Standard Deviation|Mean
696958|NCT01371786|Secondary|Initial Deposition of Radioactivity Within the Nasopharynx as a Percent of Delivered Dose|The scintigraphic measure of radioactivity initially deposited (approximately 2 minutes post-dose) within the nasopharynx, expressed as a percent of the delivered dose (i.e., the total amount of radioactivity delivered), following nasal inhalation of a ciclesonide radiolabeled solution via a novel nasal MDI and a mometasone radiolabeled suspension via an aqueous nasal spray.|Day 1 at 2 minutes post-dose|Scintigraphic Population||percentage of radiolabeled||Standard Deviation|Mean
696959|NCT01371786|Primary|Initial Deposition of Radioactivity Within the Nasal Cavity as a Percent of Delivered Dose|The scintigraphic measure of radioactivity initially deposited (approximately 2 minutes post-dose) within the nasal cavity, expressed as a percent of the delivered dose (i.e., the total amount of radioactivity delivered), following nasal inhalation of a ciclesonide radiolabeled solution via a novel nasal MDI and a mometasone radiolabeled suspension via an aqueous nasal spray.|Day 1 at 2 minutes post dose|Scintigraphic Population||percentage of radiolabeled||Standard Deviation|Mean
696960|NCT01371747|Secondary|Proportions of Participants Achieving Serum Potassium Levels Within 3.8 to 5.0 mEq/L at Week 52 for Each Individual Starting Dose Group||Baseline to Week 52|Included all randomized participants who received at least 1 dose of patiromer. Analyses of endpoints included participants with available central laboratory potassium values at the time point of interest.||percentage of participants||95% Confidence Interval|Number
696961|NCT01371747|Secondary|Time to First Serum Potassium Measurement of 4.0 - 5.0 mEq/L During Treatment Initiation Period for Each Individual Starting Dose Group||Baseline to Week 8|Included all randomized participants who received at least 1 dose of patiromer. Analyses of endpoints included participants with available central laboratory potassium values at the time point of interest.||Days||95% Confidence Interval|Median
696962|NCT01371747|Secondary|Proportion of Participants Achieving Serum Potassium Levels Within 4.0 to 5.0 mEq/L at Week 8 for Each Individual Starting Dose Group||Baseline to Week 8|Included all randomized participants who received at least 1 dose of patiromer. Analyses of endpoints included participants with available central laboratory potassium values at the time point of interest.||percentage of participants||95% Confidence Interval|Number
696963|NCT01371747|Secondary|Proportion of Participants Achieving Serum Potassium Levels Within 3.5 to 5.5 mEq/L at Week 8 for Each Individual Starting Dose Group||Baseline to Week 8|Included all randomized participants who received at least 1 dose of patiromer. Analyses of endpoints included participants with available central laboratory potassium values at the time point of interest.||percentage of participants||95% Confidence Interval|Number
696964|NCT01371747|Secondary|Mean Change in Serum Potassium From Week 52 or Last Patiromer Dose (if Occurred Before Week 52) to Follow-up Visits Plus 7 Days||Week 52 or Last Patiromer Dose (if Occurred before Week 52) to Following up Visit Plus 7 Days|Included all randomized participants who received at least 1 dose of patiromer. Analyses of endpoints included participants with available central laboratory potassium values at the time point of interest.||mEq/L||Standard Deviation|Mean
696965|NCT01371747|Secondary|Mean Change in Serum Potassium From Baseline to Week 52 During the Long-term Maintenance Period for Each Individual Starting Dose Group||Baseline to Week 52|Included all randomized participants who received at least 1 dose of patiromer. Analyses of endpoints included participants with available central laboratory potassium values at the time point of interest.||mEq/L||Standard Deviation|Mean
696966|NCT01371747|Secondary|Least Squares Mean Change in Serum Potassium From Baseline to Day 3 During the Treatment Initiation Period for Each Individual Starting Dose Group|Least squares mean changes from Baseline to Day 3 were derived from parallel lines ANCOVA model with randomized starting dose and baseline serum potassium value as covariates.|Baseline to Day 3|Included all randomized participants who received at least 1 dose of patiromer. Analyses of endpoints included participants with available central laboratory potassium values at the time point of interest.||mEq/L||Standard Error|Least Squares Mean
696967|NCT01371747|Secondary|Least Squares Mean Change in Serum Potassium From Baseline to Week 8 or Time of First Titration for Each Individual Starting Dose Group|Least squares mean changes from Baseline to Week 8/first titration were derived from parallel lines ANCOVA model with randomized starting dose and baseline serum potassium value as covariates.|Baseline to Week 8 or First Titration which could occur at any scheduled study visit after patiromer initiation.|Included all randomized participants who received at least 1 dose of patiromer. Analyses of endpoints included participants with available central laboratory potassium values at the time point of interest.||mEq/L||Standard Error|Least Squares Mean
696968|NCT01371747|Primary|Least Squares Mean Change in Serum Potassium From Baseline to Week 4 or Time of First Titration for Each Individual Starting Dose Group|Least square mean changes from Baseline to Week 4/first titration were derived from parallel lines ANCOVA model with randomized starting dose and baseline serum potassium value as covariates.|Baseline to Week 4 or First Titration which could occur at any scheduled study visit after patiromer initiation.|Included all randomized participants who received at least 1 dose of patiromer. Analyses of endpoints included participants with available central laboratory potassium values at the time point of interest.||mEq/L||Standard Error|Least Squares Mean
696969|NCT01371734|Secondary|Percentage of Participants With a CGI-I Response Defined as a Score of 'Very Much Improved' or 'Much Improved'|A 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale. Higher score = more affected.|Weeks 1, 2, 3, 4, 6, and 8|ITT Population n is the number of participants with non-missing values||Percentage of Participants|||Number
696970|NCT01371734|Secondary|Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8|A 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score equals (=) more affected.|Weeks 1, 2, 3, 4, 6, and 8|ITT Population n is the number of participants with non-missing values||Percentage of Participants|||Number
696971|NCT01371734|Secondary|Change From Baseline to Week 8 in the Clinical Global Impression of Severity (CGI-S) Score (n=102, 105, 106)|A 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Change: score at observation minus score at baseline. Mean change from baseline was adjusted for the baseline total score, age group and gender.|Baseline and Week 8|ITT Population n is the number of participants with evaluable data.||Score on a scale||Standard Error|Least Squares Mean
696972|NCT01371734|Primary|Change From Baseline to Week 8 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score (n=102, 104, 106)|Clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment. Mean change from baseline was adjusted for the baseline total score, age group and gender.|Baseline and Week 8|"Intention-To-Treat (ITT) Population - included all randomized participants who received at least 1 dose of study drug, had a baseline primary efficacy assessment, and had at least one post-baseline primary efficacy assessment.
n is the number of participants with evaluable data."||Score on a scale||Standard Error|Least Squares Mean
696973|NCT01371721|Secondary|Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Week 26 Based on Observed Cases|A 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study|ITT-included all randomized participants who had a baseline (of study B2061031) CDRS-R evaluation (Week 9 of study B2061014) took at least 1 dose of study drug and had at least 1 CDRS-R evaluation after the first dose of study drug in the B2061031 study period.||Percentage of Participants|||Number
696974|NCT01371721|Primary|Percentage of Participants Experiencing a Treatment Emergent Adverse Event||Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study|Safety Population-includes all treatment-assigned participants who took at least one dose of investigational product in the period of study B2061031.||Percentage of Participants|||Number
696975|NCT01371721|Secondary|Percentage of Participants With Remission as Determined by a CDRS-R Score of ≤28 at Week 26 Based on Observed Cases|Clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment. Adjusted mean presented.|Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study|ITT-included all randomized participants who had a baseline (of study B2061031) CDRS-R evaluation (Week 9 of study B2061014) took at least 1 dose of study drug and had at least 1 CDRS-R evaluation after the first dose of study drug in the B2061031 study period.||Percentage of Participants|||Number
696976|NCT01371721|Secondary|Percentage of Participants With a Clinical Global Impression, Improvement (CGI-I) Response Defined as a Score of 'Very Much Improved' or 'Much Improved' at Week 26|A 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Higher score = more affected.|Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study|ITT-included all randomized participants who had a baseline (of study B2061031) CDRS-R evaluation (Week 9 of study B2061014) took at least 1 dose of study drug and had at least 1 CDRS-R evaluation after the first dose of study drug in the B2061031 study period.||Percentage of Participants|||Number
696977|NCT01371721|Secondary|Change From Baseline at Week 26 in the Clinical Global Impression of Severity (CGI-S) Score Based on Observed Cases|A 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Change: score at observation minus score at baseline. Adjusted mean presented.|Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study|ITT-included all randomized participants who had a baseline (of study B2061031) CDRS-R evaluation (Week 9 of study B2061014) took at least 1 dose of study drug and had at least 1 CDRS-R evaluation after the first dose of study drug in the B2061031 study period.||Score on a Scale||Standard Deviation|Mean
696978|NCT01371721|Secondary|Change From Baseline at Week 26 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score Based on Observed Cases|Clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment. Adjusted mean presented.|Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study|ITT-included all randomized participants who had a baseline (of study B2061031) CDRS-R evaluation (Week 9 of study B2061014) took at least 1 dose of study drug and had at least 1 CDRS-R evaluation after the first dose of study drug in the B2061031 study period.||Score on a Scale||Standard Deviation|Mean
696979|NCT01371708|Secondary|Percentage of Participants With Remission at Week 26, Based on a Score on the Children's Depression Rating Scale, Revised (CDRS-R), <=28 and on Observed Cases (Combination Group)|Remission on the CDRS-R was defined as a CDRS-R score <=28. The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total s cores indicate lower intensity of symptoms.|From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030|All participants who had a CDRS-R evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030, and were available for evaluation.||Percentage of participants|||Number
696980|NCT01371708|Secondary|Percentage of Participants With Remission at Week 26, Based on Score on the Children's Depression Rating Scale, Revised (CDRS-R), <=28 and on Observed Cases|Remission on the CDRS-R was defined as a CDRS-R score <=28. The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total s cores indicate lower intensity of symptoms.|From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030|All participants who had a CDRS-R evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, and had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030.||Percentage of participants|||Number
696981|NCT01371708|Secondary|Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases (Combination Group)|The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale used a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing “very much improved” and 7 representing “very much worse”; a value of 0 meant not assessed. Lower score indicates greater improvement. Response on the CGI-I defined as the CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.|From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030|All participants who had a Children's Depression Rating Scale-Revised (CDRS-R) evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030, and were available for evaluation.||Percentage of participants|||Number
696982|NCT01371708|Secondary|Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases|The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale used a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing “very much improved” and 7 representing “very much worse”; a value of 0 meant not assessed. Lower score indicates greater improvement. Response on the CGI-I defined as the CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.|From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030|All participants who had a Children's Depression Rating Scale-Revised (CDRS-R) evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, and had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030.||Percentage of participants|||Number
696983|NCT01371708|Secondary|Percentage of Participants With a Response of Very Much Improved or Much Improved on the Clinical Global Impression-Improvement (CGI-I) Scale at Week 26, Based on Observed Cases (Combination Group)|The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing “very much improved” and 7 representing “very much worse”; a value of 0 meant not assessed. Lower score indicates greater improvement. Response on the CGI-I defined as the CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.|From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030|All participants who had a Children's Depression Rating Scale-Revised (CDRS-R) evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030, and were available for evaluation.||Percentage of participants|||Number
696995|NCT01371552|Primary|"Percentage of Participants Responding Yes"|The participant responded to 11 subjective, performance-related statements on a questionnaire by circling 1 = yes, 2 = no, or 3 = don't know.|Part 2: Day 7|This reporting group includes all participants who completed Part 2.||Percentage of participants|||Number
696996|NCT01371552|Primary|Lens Wettability|Lens wettability was assessed by the investigator during slit-lamp examination and graded on a 0-4 scale in 0.25 steps, where 0 = excellent and 4 = severely reduced.|Part 1: Day 1 at Dispense, Day 1 at 8 hours, Day 3 at 8 hours|This reporting group includes all participants who completed all three lens wear periods in Part 1.||Units on a scale||Standard Deviation|Mean
697315|NCT01368081|Secondary|Change From Baseline in HbA1c|Change from baseline in HbA1c after 52 weeks of treatment|Baseline and 52 weeks|Full analysis set||percentage of HbA1c||Standard Error|Least Squares Mean
696984|NCT01371708|Secondary|Percentage of Participants With a Response of Very Much Improved or Much Improved on the Clinical Global Impression-Improvement (CGI-I) Scale at Week 26, Based on Observed Cases|The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing “very much improved” and 7 representing “very much worse”; a value of 0 meant not assessed. Lower score indicates greater improvement. Response on the CGI-I defined as the CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.|From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030|All participants who had a Children's Depression Rating Scale-Revised (CDRS-R) evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, and had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030.||Percentage of participants|||Number
696985|NCT01371708|Secondary|Change in Score From Baseline to Week 26 on the Clinical Global Impression-Severity (CGI-S) Scale, Based on Observed Cases (Combination Group)|The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-S, which rates the severity of illness from 1 to 7, and the CGI-Improvement Scale, which assesses improvement in illness since baseline. The CGI-S is a 7-point scale a clinician uses to rate a patient's severity of illness. Scores range from 1 to 7, with 1 indicating “normal, not at all ill” and 7, “among the most extremely ill patients.” Higher score on the CGI-S indicates greater severity of illness. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.|From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030|All participants who had a Children's Depression Rating Scale-Revised (CDRS-R) evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030, and were available for evaluation.||Units on a scale||Standard Deviation|Mean
696986|NCT01371708|Secondary|Change in Score From Baseline to Week 26 on the Clinical Global Impression-Severity (CGI-S) Scale, Based on Observed Cases|The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-S, which rates the severity of illness from 1 to 7, and the CGI-Improvement Scale, which assesses improvement in illness since baseline. The CGI-S is a 7-point scale a clinician uses to rate a patient's severity of illness. Scores range from 1 to 7, with 1 indicating “normal, not at all ill” and 7, “among the most extremely ill patients.” Higher score on the CGI-S indicates greater severity of illness. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.|From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030|All participants who had a Children's Depression Rating Scale-Revised (CDRS-R) evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, and had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030.||Units on a scale||Standard Deviation|Mean
696987|NCT01371708|Secondary|Change From Baseline to Week 26 in Total Score on the Children's Depression Rating Scale, Revised (CDRS-R), Based on Observed Cases (Combination Group)|The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total scores indicate lower intensity of symptoms. Remission on the CDRS-R was defined as a CDRS-R score <=28. It was recommended that the CDRS-R be performed prior to the Clinical Global Impression assessments. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.|From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030|All participants who had a CDRS-R evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030, and were available for evaluation.||Units on a scale||Standard Deviation|Mean
696988|NCT01371708|Secondary|Change From Baseline to Week 26 in Total Score on the Children's Depression Rating Scale, Revised (CDRS-R), Based on Observed Cases|The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total scores indicate lower intensity of symptoms. Remission on the CDRS-R was defined as a CDRS-R score <=28. It was recommended that the CDRS-R be performed prior to the Clinical Global Impression assessments. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.|From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030|All participants who had a CDRS-R evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, and had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030.||Units on a scale||Standard Deviation|Mean
696989|NCT01371708|Primary|Percentage of Participants With a Treatment-emergent Adverse Event (TEAE) (Combination Group)|A TEAE was defined as an event that was absent before treatment and emerged or worsened during the treatment period.|From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030|All participants who received at least 1 dose of study drug in study B2061030||Percentage of participants|||Number
696990|NCT01371708|Primary|Percentage of Participants With a Treatment-emergent Adverse Event (TEAE)|A TEAE was defined as an event that was absent before treatment and emerged or worsened during the treatment period.|From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030|All participants who received at least 1 dose of study drug in study B2061030||Percentage of participants|||Number
696991|NCT01371643|Secondary|Percentage of Responders (Only Including Surgical Failures in Arm 2)|Nadir growth hormone <1 ng/mL during a standard 2 hour oral glucose tolerance test using 75 g glucose and normal IGF-I according to age and gender-matched standards.|3 months|||percentage of participants||95% Confidence Interval|Number
696992|NCT01371643|Primary|Percentage of Responders (All Treatments)|Nadir growth hormone <1 ng/mL during a standard 2 hour oral glucose tolerance test using 75 g glucose and normal IGF-I according to age and gender-matched standards.|3 months|||percentage of participants||95% Confidence Interval|Number
696993|NCT01371643|Primary|Percentage of Responders (Primary Medical Treatment in Arm 1, Primary Surgical Treatment in Arm 2)|Nadir growth hormone <1 ng/mL during a standard 2 hour oral glucose tolerance test using 75 g glucose and normal IGF-I according to age and gender-matched standards.|3 months|||percentage of participants||95% Confidence Interval|Number
696997|NCT01371552|Primary|Percentage of Participants Preferring Study Lens Either Strongly or Slightly (of Those With a Preference) vs. Their Habitual Lenses at End of Wear|"The participant circled a number from 1 to 5 in response to the question, Overall, which lens do you prefer - the lens you wore today or your regular lenses? in which 1 = strongly prefer my regular lenses, 2 = prefer my regular lenses, 3 = no preference, 4 = prefer test lens, 5 = strongly prefer test lens. The end of wear questionnaire was completed at time of lens removal for that day."|Part 1: Day 3|This reporting group includes all participants who completed all three lens wear periods in Part 1.||Percentage of participants|||Number
696998|NCT01371552|Primary|Percentage of Participants Reporting That Their Eyes Rarely or Never Felt Dry at End of Wear|"The participant circled a number from 0 to 4 in response to the question, Over the entire day while wearing these contact lenses, how often did your eyes feel dry? in which 0 = never, 1 = rarely, 2 = sometimes, 3 = frequently, 4 = constantly. The end of wear questionnaire was completed at time of lens removal for that day."|Part 1: Day 2|This reporting group includes all participants who completed all three lens wear periods in Part 1.||Percentage of participants|||Number
696999|NCT01371552|Primary|Mean Overall Ease of Handling at End of Wear|"The participant recorded a number from 0 to 100 in response to the question, How would you rate the overall ease of handling these lenses? in which 0 = very difficult and 100 = very easy. The end of wear questionnaire was completed at time of lens removal for that day."|Part 1: Day 3|This reporting group includes all participants who completed all three lens wear periods in Part 1.||Units on a scale||Standard Deviation|Mean
697000|NCT01371552|Primary|Mean Overall Quality of Vision at End of Wear|"The participant recorded a number from 0 to 100 in response to the question, How would you rate the overall quality of vision while wearing these lenses? in which 0 = very poor and 100 = excellent. The end of wear questionnaire was completed at time of lens removal for that day."|Part 1: Day 3|This reporting group includes all participants who completed all three lens wear periods in Part 1.||Units on a scale||Standard Deviation|Mean
697001|NCT01371552|Primary|Mean Overall Comfort Given at End of Wear|"The participant recorded a number from 0 to 100 in response to the question, How would you rate the overall comfort of these lenses? in which 0 = very poor and 100 = excellent. The end of wear questionnaire was completed at time of lens removal for that day."|Part 1: Day 3|This reporting group includes all participants who completed all three lens wear periods in Part 1.||Units on a scale||Standard Deviation|Mean
697002|NCT01371552|Primary|Mean Value of Comfort During the Day|"The participant recorded a number from 0 to 100 in response to the question, How would you rate the comfort of your lenses over the last hour? in which 0 = very poor and 100 = excellent. Comfort was assessed at 4 hours, 8 hours, and 12 hours, and the responses were averaged."|Part 1: Day 2 at 4 hours, 8 hours, and 12 hours|This reporting group includes all participants who completed 12 hours of lens wear on Day 2.||Units on a scale||Standard Deviation|Mean
697003|NCT01371539|Primary|Corrected Near Binocular Visual Measurement in Normal Illumination Reported as Binocular Near Visual Acuity|The participant read a Snellen chart at 40 centimeters with both eyes together while wearing study lenses. The Snellen acuity was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equated to a logMAR acuity of 0.0 and was considered normal near eyesight. A positive logMAR value indicated poorer vision, and a negative value denoted better visual acuity.|1 week|The Efficacy Evaluable Set (EES) contained all enrolled and dispensed subjects with no major protocol deviations as determined by masked review that also completed a minimum of 4 days of lens wear with either study product and attended an assessing follow-up visit.||logMAR||Standard Deviation|Mean
697004|NCT01371539|Primary|Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity|The participant read a Snellen chart at a 20-foot equivalent distance with both eyes together while wearing study lenses. The Snellen acuity was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equated to a logMAR acuity of 0.0 and was considered normal distance eyesight. A positive logMAR value indicated poorer vision, and a negative value denoted better visual acuity.|1 week|The Efficacy Evaluable Set (EES) contained all enrolled and dispensed subjects with no major protocol deviations as determined by masked review that also completed a minimum of 4 days of lens wear with either study product and attended an assessing follow-up visit.||logMAR||Standard Deviation|Mean
697007|NCT01371006|Secondary|Group B - Number of Participants With Drug Related Adverse Events|"Number of participants with investigator-defined drug related adverse events (AE) in sequence group B. AEs occurring up to 5 days after last intake of Faldaprevir were assigned to Faldaprevir+Midazolam+Efavirenz treatment.
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone."|From Day 1 up to 30 days after last treatment (Days 1,2,6,8,9,10,11,14,17,18,19,24)|all subjects entered in sequence group B of the treated set.||participants|||Number
697008|NCT01371006|Secondary|Group A - Number of Participants With Drug Related Adverse Events|"Number of participants with investigator-defined drug related adverse events (AE) in sequence group A. AEs occurring up to 5 days after last intake of Faldaprevir on day 19 were assigned to Efavirenz+Faldaprevir treatment.
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone."|From Day 1 up to 30 days after last treatment (Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24)|all subjects entered in sequence group A of the treated set.||participants|||Number
697009|NCT01371006|Secondary|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Physical Examination and ECG|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Physical Examination and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.|From first treatment administration (Day 1) up to Day 24|treated set: All subjects who were dispensed study medication and were documented to have taken at least 1 dose of trial medication||participants|||Number
697010|NCT01371006|Secondary|Group B - Midazolam: AUC0-∞|Area under the concentration-time curve of of Midazolam over the time interval 0 to infinity on days 1, 9 and 18, calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam)|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 14:00, 24:00 h after administration of Midazolam|all subjects entered in sequence group B of the PK set.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
697011|NCT01371006|Secondary|Group B - Midazolam: Tmax|Time of maximum concentration after a single dose of Midazolam on days 1, 9 and 18, calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam)|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 14:00, 24:00 h after administration of Midazolam|all subjects entered in sequence group B of the PK set.||hours||Full Range|Median
697012|NCT01371006|Secondary|Group B - Midazolam: Cmax|Maximum plasma concentration of Midazolam on days 1, 9 and 18, calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam)|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 14:00, 24:00 h after administration of Midazolam|all subjects entered in sequence group B of the PK set.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
697013|NCT01371006|Secondary|Group B - Faldaprevir: Tmax,ss|Time of maximum concentration of Faldaprevir on Day 9 and 10 at steady state, calculated for patients in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam)|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Faldaprevir|All patients entered in sequence group B of the PK set||hours||Full Range|Median
697014|NCT01371006|Secondary|Group A - Efavirenz: Tmax|Time of maximum concentration of Efavirenz on day 14, calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz)|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Efavirenz|All patients entered in sequence group A of the PK set||hours||Full Range|Median
697015|NCT01371006|Secondary|Group A – Faldaprevir: C12,ss|Plasma concentration 12 h after dosing of Faldaprevir on day 14 at steady state, calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz)|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Faldaprevir|All patients entered in sequence group A of the PK set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
697016|NCT01371006|Secondary|Group A – Faldaprevir: AUC0-12h,ss|Area under the concentration-time curve of Faldaprevir over the time interval 0-12h on day 14 at steady state, calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz)|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Faldaprevir|All patients entered in sequence group A of the PK set||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
697017|NCT01371006|Secondary|Group A – Faldaprevir: Tmax,ss|Time of maximum concentration of Faldaprevir on day 14 at steady state, calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz)|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Faldaprevir|All patients entered in sequence sequence group A of the PK set||hours||Full Range|Median
697018|NCT01371006|Secondary|Group A – Faldaprevir: Cmax,ss|Maximum plasma concentration of Faldaprevir on day 14 at steady state, calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz)|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Faldaprevir|All patients entered in sequence group A of the PK set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
697019|NCT01371006|Primary|Group B - Faldaprevir: C12,ss|Plasma concentration 12 h after dosing of Faldaprevir at steady state calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam)|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after first administration of Faldaprevir|all subjects entered in sequence group B of the PK set.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
697020|NCT01371006|Primary|Group B - Faldaprevir: AUC0-12h,ss|Area under the concentration-time curve of Faldaprevir at steady state over the time interval 0 to 12h calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam)|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after first administration of Faldaprevir|all subjects entered in sequence group B of the PK set.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
697021|NCT01371006|Primary|Group B - Faldaprevir: Cmax,ss|Maximum plasma concentration at steady state of Faldaprevir calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam)|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after first administration of Faldaprevir|all subjects entered in sequence group B of the PK set.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
697022|NCT01371006|Primary|Group A - Efavirenz: AUC0-∞|Area under the concentration-time curve of the analyte in plasma over the time interval 0 to infinity of Efavirenz calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz)|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00, 144:00 h after administration of Efavirenz|all subjects entered in sequence group A of the PK set.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
697023|NCT01371006|Primary|Group A - Efavirenz: Cmax|Maximum plasma concentration (Cmax) of Efavirenz calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz)|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00, 144:00 hours(h) after administration of Efavirenz|all subjects entered in sequence group A of the PK set. Pharmacokinetic (PK) set: This subject set included all subjects of the treated set who provided evaluable data for at least1 observation for at least 1 primary PK endpoint in any trial period without important protocol violations.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
697024|NCT01370863|Secondary|Change From Baseline in the Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM) Questionnaire at 4 Weeks|The PAGI-SYM contains 20 items and the scores range from 0 (no symptoms)-5 (very severe symptoms) for each item with a total score of 0-100. Higher scores indicate more severe gastrointestinal symptoms.|Baseline and 4 weeks|Pharmacodynamics Population (PD) defined as all randomized subjects with at least 1 administration of the investigational product and with both a baseline and post-baseline PD assessment.||Units on a scale||Standard Deviation|Mean
697026|NCT01370863|Primary|Change From Baseline in the Number of Liquid-containing Reflux Events (pH/MII Monitoring) at 4 Weeks|This is used to characterize gastric reflux events. The measurements were made over a 24-hour period at baseline and again at week 4.|Baseline and 4 weeks|Pharmacodynamics Population (PD) defined as all randomized subjects with at least 1 administration of the investigational product and with both a baseline and post-baseline PD assessment.||Number of Reflux Events||Standard Deviation|Mean
697027|NCT01370837|Primary|Induration Size as a Response to Intracutaneous Candida Albicans.||48 hours after injection.|||millimeters||95% Confidence Interval|Median
697028|NCT01370733|Secondary|Number of Subjects Who Demonstrate Clinical Remission at Week 6 or Early Termination (Per Protocol - Non-Naive Subjects)|"The Hamilton Rating Scale for Depression (HAM-D17) was utilized to determine clinical remission. Remission is defined as a total HAM-D17 score ≤ 7. All subjects in the Per Protocol population completed Week 6. This analysis includes only PP subjects exposed to an antidepressant medication in their current episode (non-naive).
This outcome provides the total number of subjects in each arm that achieved clinical remission at Week 6 within the Non-Naive, Per Protocol population.
The Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity."|Baseline to End of Double-Blind Treatment Period (Week 6)|Per Protocol Population - Non-Naive Subjects||participants|||Number
697029|NCT01370733|Secondary|Number of Subjects Who Demonstrate Clinical Remission at Week 6 (Per Protocol - All)|"For this outcome, the Hamilton Rating Scale for Depression (HAM-D17) was utilized to determine clinical remission. Remission is defined as a total HAM-D17 score ≤ 7. All subjects in the Per Protocol population completed Week 6.
This outcome provides the total number of subjects in each arm that achieved clinical remission within the Per Protocol population at Week 6.
The Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity."|Baseline to End of Double-Blind Treatment Period (up to week 6)|Per Protocol Population||participants|||Number
697030|NCT01370733|Secondary|Number of Subjects Who Demonstrate Clinical Remission at Week 6 or Early Termination (Intent to Treat)|"The Hamilton Rating Scale for Depression (HAM-D17) was utilized to determine clinical remission. Remission is defined as a total HAM-D17 score ≤ 7. If any subject did not complete the double-blind phase (Week 6) in the Intent to Treat (ITT) population, the assessment last observation carried forward (LOCF) was used.
This outcome provides the total number of subjects in each arm that achieved clinical remission within the ITT population.
The Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity."|Baseline to End of Double-Blind Treatment Period (Week 6)|Includes all subjects who signed an informed consent, met all I/E criteria, were subsequently randomized and received at least 1 treatment (active sTMS or sham) session in the double-blind phase.||participants|||Number
697031|NCT01370733|Secondary|Number of Subjects Who Demonstrate Clinical Response at Week 6 (Per Protocol - Non-Naive Subjects)|"The Hamilton Rating Scale for Depression (HAM-D17) was utilized to determine clinical response, defined as a reduction of at least 50% in total HAM-D17 score from Baseline through Week 6. All subjects in the Per Protocol (PP) population completed Week 6. This analysis includes only PP subjects exposed to an antidepressant medication in their current episode (non-naive).
This outcome provides the total number of subjects in each arm that achieved clinical response within the Non-Naive, Per Protocol population.
The Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity."|Baseline to End of Double-Blind Treatment Period (Week 6)|Per Protocol Population - Non-Naive Subjects||participants|||Number
697032|NCT01370733|Secondary|Number of Subjects Who Demonstrate Clinical Response at Week 6 (Per Protocol - All)|"For this outcome, the Hamilton Rating Scale for Depression (HAM-D17) was utilized to determine clinical response. Response is defined as a reduction of at least 50% in total HAM-D17 score from Baseline through Week 6. All subjects in the Per Protocol population completed Week 6.
This outcome provides the total number of subjects in each arm that achieved clinical response within the Per Protocol population.
The Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity."|Baseline to End of Double-Blind Treatment Period (Week 6)|Per Protocol Population||participants|||Number
697033|NCT01370733|Secondary|Number of Subjects Who Demonstrate Clinical Response at Week 6 or Early Termination (Intent to Treat)|"For this outcome, the Hamilton Rating Scale for Depression (HAM-D17) was utilized to determine clinical response. Response is defined as a reduction of at least 50% in total HAM-D17 score from Baseline through Week 6. If any subject did not complete the double-blind phase (Week 6) in the ITT population, the assessment last observation carried forward (LOCF) was used.
This outcome provides the total number of subjects in each arm that achieved clinical response within the Intent to Treat population.
The Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity."|Baseline to End of Double-Blind Treatment Period (Week 6)|||participants|||Number
697034|NCT01370733|Secondary|Mean HAM-D17 Total Score Change (Per Protocol - Non-Naive Subjects)|"All subjects in the Per Protocol analysis completed Week 6. Baseline HAM-D17 total score was directly compared to Week 6 HAM-D17 total score. The single value provided in each arm reflects this change.
This analysis included only Per Protocol subjects exposed to an antidepressant medication in their current episode (non-naive). This includes past history of intolerance, resistance, or inadequate dosing/duration.
The Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset of the HAM-D28, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. The HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity. A reduction of 50% or more in total score from Baseline indicates clinical response."|Baseline to End of Double-Blind Treatment Period (Week 6)|Per Protocol Population - Non-Naive Subjects||units on a scale||Standard Deviation|Mean
697035|NCT01370733|Primary|Mean HAM-D17 Total Score Change (Per Protocol - All)|"The mean HAM-D17 total score change from Baseline (Day 0) to Week 6 compared between the active treatment and sham-controlled groups. All subjects in the Per Protocol analysis completed Week 6. Baseline HAM-D17 total score was directly compared to the HAM-D17 total score at Week 6. The single value provided in each arm reflects the change seen.
For this trial, the Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset of the HAM-D28, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. The HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity. A reduction of 50% or more in total score from Baseline indicates clinical response."|Baseline to End of Double-Blind Treatment Period (Week 6)|Per Protocol Population||units on a scale||Standard Deviation|Mean
697036|NCT01370733|Primary|Mean HAM-D17 Total Score Change (Intent to Treat - All)|"The mean HAM-D17 total score change from Baseline (Day 0) to Week 6 compared between the active treatment and sham-controlled groups. If any subject did not complete the double-blind phase in the ITT population, the assessment last observation carried forward (LOCF) was used. The single value provided in each arm reflects the change seen.
For this trial, the Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset of the HAM-D28, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. The HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity. A reduction of 50% or more in total score from Baseline indicates clinical response."|Baseline to End of Double-Blind Treatment Period (Week 6)|Includes all subjects who signed an informed consent, met all I/E criteria, were subsequently randomized and received at least 1 treatment (active sTMS or sham) session in the double-blind phase.||units on a scale||Standard Deviation|Mean
697037|NCT01370694|Secondary|Clinical Response of Tumor to MK-8808/CVP Combination Therapy|The response of the tumor to MK-8808/CVP combination therapy was radiographically assessed using Response Criteria Evaluation in Solid Tumors (RECIST). Response categories of partial response (PR), complete resonse (CR), and uncomfirmed (CRu) central review.|Up to 2 years|All participants with evaluable data||Participants|||Number
697038|NCT01370694|Secondary|Ctrough of Plasma Levels of MK-8808 When Used as Single Agent Maintenance|Ctrough is a measure of the lowest level of drug in the plasma over time, using plasma samples collected at specified time points.|Predose and end of infusion in every other cycle and at end of therapy visit (up to 2 years)|No participants progressed to MK-8808 single agent maintenance therapy; this outcome measure was not assessed.|||||
697039|NCT01370694|Secondary|Lowest Concentration (Ctrough) of Plasma Levels of MK-8808 When Used in Combination With CVP|Ctrough is a measure of the lowest level of drug in the plasma over time, using plasma samples collected at specified time points.|Pre-dose and end of infusion in each 21-day cycle and at end of therapy visit (up to 24 weeks)|This analysis was not done due to early termination of the study.|||||
697040|NCT01370694|Secondary|Cmax of Plasma Levels of MK-8808 During Single Agent Maintenance Therapy|Cmax is a measure of the maximum amount of drug in the plasma over time using samples taken at specified time points.|Predose and end of infusion in every other cycle and at end of therapy visit (up to 2 years)|No participants progressed to MK-8808 single agent maintenance therapy; this outcome measure was not assessed.|||||
697041|NCT01370694|Secondary|Maximum Concentration (Cmax) of Plasma Levels of MK-8808 When Used in Combination With CVP|Cmax is a measure of the maximum concentration of the drug in the plasma as measured using plasma samples taken over specified time points.|Pre-dose and end of infusion in each 21-day cycle and at end of therapy visit (up to 24 weeks)|This analysis was not done due to early termination of the study.|||||
697042|NCT01370694|Primary|Number of Participants Experiencing Clinical and Laboratory AEs During MK-8808 Maintenance Therapy|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.|From first dose of single agent MK-8808 up to 2 years|No participants progressed to MK-8808 single agent maintenance therapy; this outcome measure was not assessed.|||||
697043|NCT01370694|Primary|Number of Participants Experiencing Clinical and Laboratory Adverse Events (AEs) During MK-8808/CVP Combination Therapy|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.|From first dose of combination therapy up to 24 weeks|All participants receiving at least one dose of any study drug.||Participants|||Number
697044|NCT01370655|Secondary|Change From Baseline in Urine Potassium at 24 Hours Post-dose on Day 28|Urine potassium (K+) levels were measured over 24-hours on Day -1 and on Day 28. The total amount of K+ excreted in the urine for Day-1 (baseline) and Day 28 were calculated and the difference between the 2 values was recorded.|Baseline (Day -1) and Day 28|All participants who received at least 1 dose of study drug, complied with protocol sufficiently and had available data for endpoint. Participants are grouped by study drug taken at the time of the evaluation and not by randomly assigned sequence.||mmol/day||90% Confidence Interval|Least Squares Mean
697338|NCT01367860|Secondary|VAS for Leg Pain - 6rd Month|Pain Score for leg pain - Visual Analog Scale (VAS) -> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome.|6th month from surgery|Intention to treat||units on a scale||Standard Deviation|Mean
697045|NCT01370655|Primary|Percentage of Participants Who Experienced at Least 1 Drug-related Adverse Event (AE)|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants who experienced an AE that was reported as at least possibly-related to the study was summarized by study drug taken at the time of the AE.|Up to 14 days post last dose of each treatment period (total of 6 weeks for each treatment period)|All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence.||Percentage of Participants|||Number
697046|NCT01370655|Primary|Percentage of Participants Who Had Study Discontinued During the Study Due to an Adverse Event (AE)|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants who had the administration of the study drug discontinued during the study was summarized by study drug taken at the time of the AE. Participants may or may not have completed the study.|up to 4 weeks of each treatment period|All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence.||Percentage of Participants|||Number
697047|NCT01370655|Primary|Percentage of Participants Who Experienced at Least 1 Adverse Event (AE)|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants who experienced an AE during the study was summarized by study drug taken at the time of the AE.|Up to 14 days post last dose of each treatment period (total of 6 weeks for each treatment period)|All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence.||Percentage of Participants|||Number
697048|NCT01370655|Primary|Change From Baseline in Urine Sodium at 24 Hours Post-dose on Day 1|Urine sodium (Na) levels were measured over 24-hours on Day -1 (baseline) and on Day 1. The total amount of Na excreted in the urine for Day-1 (baseline) and Day1 were calculated and the difference between the 2 values was recorded.|Baseline (Day-1) and Day 1|All participants who received at least 1 dose of study drug, complied with protocol sufficiently and had available data for endpoint. Participants are grouped by study drug taken at the time of the evaluation and not by randomly assigned sequence.||mmol/day||90% Confidence Interval|Least Squares Mean
697049|NCT01370655|Primary|Change From Baseline in Time-weighted Average Over 24 Hours Post Dose (TWA [0-24]) in Diastolic Blood Pressure (DBP)|Each participant had their blood pressure monitored by continuous 24-hour ambulatory blood pressure monitoring (ABPM) on Days -1 and 28 of each treatment period. The average diastolic blood pressure over the 24-hour monitoring period was calculated for baseline (Day -1) and Day 28. The difference between baseline and Day 28 was calculated and recorded.|Baseline and Day 28|All participants who received at least 1 dose of study drug, complied with protocol sufficiently and had available data for endpoint. Participants are grouped by study drug taken at the time of the evaluation and not by randomly assigned sequence.||mmHg||90% Confidence Interval|Least Squares Mean
697050|NCT01370655|Primary|Change From Baseline in Time-weighted Average Over 24 Hours Post Dose (TWA [0-24]) in Systolic Blood Pressure (SBP)|Each participant had their blood pressure monitored by continuous 24-hour ambulatory blood pressure monitoring (ABPM) on Days -1 and 28 of each treatment period. The average systolic blood pressure over the 24-hour monitoring period was calculated for baseline (Day -1) and Day 28. The difference between baseline and Day 28 was calculated and recorded.|Baseline and Day 28|All participants who received at least 1 dose of study drug, complied with protocol sufficiently and had available data for endpoint. Participants are grouped by study drug taken at the time of the evaluation and not by randomly assigned sequence.||mmHg||90% Confidence Interval|Least Squares Mean
697051|NCT01370642|Primary|Percentage of Participants Who Discontinued Study Drug Due to an AE|An adverse experience was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the product, was also an adverse experience.|From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks)|All Participants Treated (APaT) Population; all participants receiving at least one dose of study treatment. One treated participant was excluded from the APaT due to a protocol violation.||percentage of participants|||Number
697052|NCT01370642|Secondary|Least Squares (LS) Mean Change From Baseline in HCV RNA (Log 10)|"HCV RNA levels were assessed at baseline (BL) and during treatment weeks 2, 4, 8, 12, and 24 using the Roche TaqMan HCV assay, and transformed to Log 10 values. HCV RNA values below the limit of reliable quantification (LoQ) or the limit of detection (LoD) at any time point were handled as follows (imputations done for computational purposes): values below the LoQ but above the LoD were imputed with the LoQ minus 0.1; values below the LoD were imputed with the value of 0 Log IU/mL. HCV RNA levels below the LoD were considered undetectable."|Baseline, Week 2, Week 4, Week 8, Week 12, Week 24|FAS population; all randomized participants who received at least one dose of study treatment. One treated participant was excluded from the FAS due to a protocol violation.||Log IU/ml||95% Confidence Interval|Least Squares Mean
697074|NCT01370590|Secondary|Percent Change From Baseline in Triglycerides (TG) After 6 Weeks of Treatment|Serum TG measured at baseline and after 6 weeks of treatment in each of the 2 treatment periods.|Baseline and Week 6|Per-Protocol Population, which excluded participants due to important deviations from the protocol that may have substantially affected the results of the primary efficacy endpoint(s). A participant could be excluded from 1 or more of the analyses. Results are reported by treatment formulation and not by sequence.||Percentage Change||95% Confidence Interval|Least Squares Mean
697053|NCT01370642|Primary|Percentage of Participants With One or More Tier 1 Adverse Events (AEs) During the Study|An adverse experience was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the product, was also an adverse experience. For this study, safety parameters or AEs of special interest that were identified a priori constituted “Tier 1” safety endpoints that were subject to inferential testing for statistical significance. Tier 1 AEs on this study included serious rash, anemia (anemia plus haemoglobin decreased), neutropenia (neutropenia plus neutrophil count decreased), bilirubin increased and gastrointestinal adverse (GI) experiences (vomiting, nausea, and diarrhea).|From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks)|All Participants Treated (APaT) Population; all participants receiving at least one dose of study treatment. One treated participant was excluded from the APaT due to a protocol violation.||percentage of participants|||Number
697054|NCT01370642|Secondary|Percentage of Participants Achieving Undetectable HCV RNA at the End of Treatment (EOT)|Participants were assessed for undetectable HCV RNA levels at the end of all study therapy.|At Week 24 or 48|FAS population; all randomized participants who received at least one dose of study treatment. One treated participant was excluded from the FAS due to a protocol violation.||percentage of participants|||Number
697055|NCT01370642|Secondary|Percentage of Participants Achieving Complete Early Virologic Response (cEVR)|cEVR was defined as having an undetectable HCV RNA level at Week 12.|At Week 12|FAS population; all randomized participants who received at least one dose of study treatment. One treated participant was excluded from the FAS due to a protocol violation.||percentage of participants|||Number
697056|NCT01370642|Secondary|Percentage of Participants Achieving Rapid Virologic Response (RVR)|RVR was defined as having an undetectable HCV RNA level at Week 4.|At Week 4|FAS population; all randomized participants who received at least one dose of study treatment. One treated participant was excluded from the FAS due to a protocol violation.||percentage of participants|||Number
697057|NCT01370642|Secondary|Percentage of Participants Achieving SVR12|SVR12 was defined as having an undetectable HCV RNA level 12 weeks after completion of all study therapy.|12 weeks after 24 or 48 weeks of study therapy (up to 60 weeks)|FAS population; all randomized participants who received at least one dose of study treatment. One treated participant was excluded from the FAS due to a protocol violation.||percentage of participants|||Number
697058|NCT01370642|Primary|Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Completion of All Study Therapy (SVR24)|SVR24 was defined as having an undetectable HCV RNA level 24 weeks after completion of all study therapy.|24 weeks after 24 or 48 weeks of study therapy (up to 72 weeks)|Full Analysis Set (FAS) population; all randomized participants who received at least one dose of study treatment. One treated participant was excluded from the FAS due to a protocol violation.||percentage of participants|||Number
697059|NCT01370616|Secondary|Percentage of Participants Who Discontinued Treatment Due to an AE|Participants chose to discontinue treatment or were discontinued from the study by the investigator due to any untoward effects, or for safety reasons such as an AE. The investigator determined whether or not the AE caused the test drug to be discontinued.|Up to day 28|Participants who received at least one dose of IV study therapy||Percentage of participants|||Number
697060|NCT01370616|Secondary|Percentage of Participants With Serious AEs (SAEs)|A SAE is an AE occurring at any dose that resulted in any of the following: death, was life threatening, a persistent or significant disability/incapacity, prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect in an offspring, was a cancer, an overdose, or other important medical events requiring medical or surgical intervention.|Up to day 42|Participants who received at least one dose of IV study therapy||Percentage of participants|||Number
697061|NCT01370616|Secondary|Percentage of Participants With Drug-related AEs|A drug-related AE is any AE caused by the test drug as determined by an investigator who is a qualified physician. Drug-relatedness of the AE was assessed by evidence that the participant was actually exposed to the test drug, whether the AE followed a reasonable temporal sequence from administration of the test drug, and whether or not the AE was more reasonably explained by another source.|Up to day 42|Participants who received at least one dose of IV study therapy||Percentage of participants|||Number
697062|NCT01370616|Secondary|Percentage of Participants With One or More Adverse Events (AEs)|An AE is any unfavorable and unintended change in the structure, function, or chemistry of the body that is temporally associated with the use of the investigational product, whether or not considered related to the use of the medicinal product. This also includes any change in frequency and/or intensity of a preexisting condition which is temporally associated with the use of the medicinal product.|Up to day 42|Participants who received at least one dose of IV study therapy||Percentage of participants|||Number
697063|NCT01370616|Secondary|Percentage of Participants With Both Favorable Clinical and Microbiological Response Assessments at FUA Day 10 of Post-antibiotic Study Therapy|The investigator assessed participants for both a favorable clinical response (clinical improvement or cure) and a favorable microbiological response (eradication or presumptive eradication). Clinical improvement means that most pretherapy signs and symptoms of the index infection, had resolved, and no further IV antibiotic therapy is required. Cure means that all pretherapy signs and symptoms of the index infection had resolved, and no further IV antibiotic therapy was required. Eradication means that the original pathogen was absent from the last available culture obtained from the original site of infection. Presumptive eradication means that the participant showed cure or improvement and no appropriate material is available to follow-up culture from the original site of infection, or collection of such a specimen would cause undue discomfort.|Day 15 up to Day 38|Participants with proper clinical diagnosis, adequate study therapy and clinical assessment, appropriate antimicrobial therapy, and microbiological assessment. One participant from the Ertapenem arm with indeterminate clinical response, was excluded from the analysis. A modified LOCF (failure was carried forward), was used to impute missing data.||Percentage of participants||95% Confidence Interval|Number
697093|NCT01370408|Secondary|Number of Patients That Required First Administration of Rescue Medication Within 24 Hours|Number of patients who required the use of rescue medication (lorazepam, prochlorperazine, promethazine, metoclopramide, scopolamine, or dronabinol) within the first 24 hours|24 hours|||participants|||Number
697064|NCT01370616|Secondary|Percentage of Participants With Favorable Microbiological Response Assessments at FUA Day 10 of Post-antibiotic Study Therapy|The investigator assessed participants for a favorable microbiological response, defined as eradication or presumptive eradication. Eradication means that the original pathogen was absent from the last available culture of an adequate specimen obtained from the original site of infection. Presumptive eradication means that the participant showed cure or improvement and no appropriate material is available to follow-up culture from the original site of infection, or collection of such a specimen would cause undue discomfort.|Day 15 up to Day 38|Participants with proper clinical diagnosis, adequate study therapy, adequate clinical assessment, appropriate antimicrobial therapy, and proper microbiological assessment. A modified LOCF, where only failure was carried forward, was used to impute missing data.||Percentage of participants||95% Confidence Interval|Number
697065|NCT01370616|Secondary|Percentage of Participants With Favorable Clinical Response Assessments at Follow-up Assessment (FUA) Day 10 of Post-antibiotic Study Therapy|The investigator assessed participants for a favorable clinical response, defined as clinical improvement or cure. Clinical improvement means that most pretherapy signs and symptoms of the index infection, in particular fever, lympangitis, and purulent drainage had resolved, and no further IV antibiotic therapy was required. Cure means that all pretherapy signs and symptoms of the index infection had resolved, and no further IV antibiotic therapy was required.|Day 15 up to Day 38|Participants with a confirmed clinical diagnosis, adequate length of IV study therapy, protocol-specified visit at FUA, and no documented protocol-specific exclusions. A modified LOCF, where only failure was carried forward, was used to impute missing data.||Percentage of participants||95% Confidence Interval|Number
697066|NCT01370616|Secondary|Percentage of Participants With Favorable Clinical Response Assessments at Day 5 of IV Study Therapy|The investigator assessed participants for a favorable clinical response, defined as clinical improvement or cure. Clinical improvement means that most pretherapy signs and symptoms of the index infection, in particular fever, lympangitis, and purulent drainage had resolved, and no further IV antibiotic therapy was required. Cure means that all pretherapy signs and symptoms of the index infection had resolved, and no further IV antibiotic therapy was required.|Day 5|Participants with a confirmed clinical diagnosis, adequate length of IV study therapy, protocol-specified visit at Day 5, and no documented protocol-specific exclusions. A modified LOCF, where only failure was carried forward, was used to impute missing data.||Percentage of participants||95% Confidence Interval|Number
697067|NCT01370616|Primary|Percentage of Participants With Favorable Clinical Response Assessments at Discontinuation of Intravenous (IV) Study Therapy (DCIV)|The investigator assessed participants for a favorable clinical response, defined as clinical improvement or cure. Clinical improvement means that most pretherapy signs and symptoms of the index infection, in particular fever, lympangitis, and purulent drainage had resolved, and no further IV antibiotic therapy was required. Cure means that all pretherapy signs and symptoms of the index infection had resolved, and no further IV antibiotic therapy was required.|Day 5 up to Day 28|Participants with confirmed clinical diagnosis, adequate IV study therapy, protocol-specified visit at DCIV, and no protocol-specific exclusions. A modified last-observation-carried-forward (LOCF), where only failure was carried forward, was used to impute missing data.||Percentage of participants||95% Confidence Interval|Number
697068|NCT01370603|Secondary|Percent Change From Baseline in Triglycerides (TG) After 6 Weeks of Treatment|Serum TG measured at baseline and after 6 weeks of treatment in each of the 2 treatment periods.|Baseline and Week 6|Per-Protocol (PP) population, which excluded participants due to important deviations from the protocol that may have substantially affected the results of the primary efficacy endpoint(s). A participant may have been a protocol violator in 1 treatment period and not in the other treatment period.||Percentage Change||95% Confidence Interval|Least Squares Mean
697069|NCT01370603|Secondary|Percent Change From Baseline in Apolipoprotein (Apo) B After 6 Weeks of Treatment|Serum Apo B measured at baseline and after 6 weeks of treatment in each of the 2 treatment periods.|Baseline and Week 6|Per-Protocol (PP) population, which excluded participants due to important deviations from the protocol that may have substantially affected the results of the primary efficacy endpoint(s). A participant may have been a protocol violator in 1 treatment period and not in the other treatment period.||Percentage Change||95% Confidence Interval|Least Squares Mean
697070|NCT01370603|Secondary|Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) After 6 Weeks of Treatment|Non-HDL-C calculated at baseline and after 6 weeks of treatment in each of the 2 treatment periods.|Baseline and Week 6|Per-Protocol (PP) population, which excluded participants due to important deviations from the protocol that may have substantially affected the results of the primary efficacy endpoint(s). A participant may have been a protocol violator in 1 treatment period and not in the other treatment period.||Percentage Change||95% Confidence Interval|Least Squares Mean
697071|NCT01370603|Secondary|Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) After 6 Weeks of Treatment|Serum HDL-C measured at baseline and after 6 weeks of treatment in each of the 2 treatment periods.|Baseline and Week 6|Per-Protocol (PP) population, which excluded participants due to important deviations from the protocol that may have substantially affected the results of the primary efficacy endpoint(s). A participant may have been a protocol violator in 1 treatment period and not in the other treatment period.||Percentage Change||95% Confidence Interval|Least Squares Mean
697072|NCT01370603|Secondary|Percent Change From Baseline in Total Cholesterol (TC) After 6 Weeks of Treatment|Serum TC measured at baseline and after 6 week of treatment in each of the 2 treatment periods.|Baseline and Week 6|"Per-Protocol (PP) population, which excluded participants due to important deviations from the protocol that may have
substantially affected the results of the primary efficacy endpoint(s). A participant may have been a protocol violator in 1 treatment period and not in the other treatment period."||Percentage Change||95% Confidence Interval|Least Squares Mean
697073|NCT01370603|Primary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After 6 Weeks of Treatment|Serum LDL-C calculated using Friedewald formula at baseline and after 6 weeks of treatment in each of the 2 treatment periods.|Baseline and Week 6|Per-Protocol (PP) population, which excluded participants due to important deviations from the protocol that may have substantially affected the results of the primary efficacy endpoint(s). A participant may have been a protocol violator in 1 treatment period and not in the other treatment period.||Percentage Change||95% Confidence Interval|Least Squares Mean
697094|NCT01370408|Secondary|Patients Who Experience First Emetic Episode Within 24 Hours|Number of patients with first emetic episode experienced within 24 hours|24 hours|||participants|||Number
697075|NCT01370590|Secondary|Percent Change From Baseline in Apolipoprotein (Apo) B After 6 Weeks of Treatment|Serum Apo B measured at baseline and after 6 weeks of treatment in each of the 2 treatment periods.|Baseline and Week 6|Per-Protocol Population, which excluded participants due to important deviations from the protocol that may have substantially affected the results of the primary efficacy endpoint(s). A participant could be excluded from 1 or more of the analyses. Results are reported by treatment formulation and not by sequence.||Percentage Change||95% Confidence Interval|Least Squares Mean
697076|NCT01370590|Secondary|Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) After 6 Weeks of Treatment|Non-HDL-C measured at baseline and after 6 weeks of treatment in each of the 2 treatment periods.|Baseline and Week 6|Per-Protocol Population, which excluded participants due to important deviations from the protocol that may have substantially affected the results of the primary efficacy endpoint(s). A participant could be excluded from 1 or more of the analyses. Results are reported by treatment formulation and not by sequence.||Percentage Change||95% Confidence Interval|Least Squares Mean
697077|NCT01370590|Secondary|Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) After 6 Weeks of Treatment|Serum HDL-C calculated at baseline and after 6 weeks of treatment in each of the 2 treatment periods.|Baseline and Week 6|Per-Protocol Population, which excluded participants due to important deviations from the protocol that may have substantially affected the results of the primary efficacy endpoint(s). A participant could be excluded from 1 or more of the analyses. Results are reported by treatment formulation and not by sequence.||Percentage Change||95% Confidence Interval|Least Squares Mean
697078|NCT01370590|Secondary|Percent Change From Baseline in Total Cholesterol (TC) After 6 Weeks of Treatment|Serum TC measured at baseline and after 6 week of treatment in each of the 2 treatment periods.|Baseline and Week 6|Per-Protocol Population, which excluded participants due to important deviations from the protocol that may have substantially affected the results of the primary efficacy endpoint(s). A participant could be excluded from 1 or more of the analyses. Results are reported by treatment formulation and not by sequence.||Percentage Change||95% Confidence Interval|Least Squares Mean
697079|NCT01370590|Primary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After 6 Weeks of Treatment|Serum LDL-C calculated using Friedewald formula at baseline and after 6 weeks of treatment in each of the 2 treatment periods.|Baseline and Week 6|Per-Protocol Population, which excluded participants due to important deviations from the protocol that may have substantially affected the results of the primary efficacy endpoint(s). A participant could be excluded from 1 or more of the analyses. Results are reported by treatment formulation and not by sequence.||Percentage Change||95% Confidence Interval|Least Squares Mean
697080|NCT01370538|Primary|Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment||From randomisation to day 14|Per-protocol analysis set||Percentage of heartburn free days||Standard Deviation|Mean
697081|NCT01370538|Secondary|Number of Subjects With Heartburn 1 Day or Less During the Final Week, Second Week, First Week of Treatment|There were three separate 7 day time periods during the treatment period; The first week (days 1-7), the second week (days 8-14), and the last 7 consecutive days (last day subject reported and the prior 6). For a given subject, the second week and last 7 consecutive days are the same if the subject has recorded measurements for the entire 14 day treatment period. However, for subjects reporting anything less than 14 days the two will not be identical. For all three 7 day time periods, days when a subject did not call in (i.e., missing values) were imputed as a day with heartburn.|From randomisation to day 14|Full Analysis Set||Participants|||Number
697082|NCT01370538|Secondary|Comparison of Number of Subjects With 0, 1, 2, 3 or 4 Days With no Heartburn Over Days 1 to 4 Between Esomeprazole 20 mg and Placebo|The first 4 consecutive days subjects were on randomized treatment, between V3 and V4.|From randomisation to day 14|Full Analysis Set||Participants|||Number
697083|NCT01370538|Secondary|Number of Subjects Reporting Heartburn 2 Days or Less During the 14 Days Randomized Treatment Period|Treatment period is considered to be both weeks 1 and 2 between V3 and V4.|From randomisation to the day 14|Full Analysis Set||Participants|||Number
697084|NCT01370538|Primary|Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment||From randomisation to day 14|Full analysis set||Percentage of heartburn free days||Standard Deviation|Mean
697085|NCT01370525|Primary|Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment||From randomization to day 14|Per-protocol analysis set||Percentage||Standard Deviation|Mean
697086|NCT01370525|Secondary|Number of Subjects With Heartburn 1 Day or Less During the Final Week, Second Week, First Week of Treatment|There were three separate 7 day time periods during the treatment period; The first week (days 1-7), the second week (days 8-14), and the last 7 consecutive days (last day subject reported and the prior 6). For a given subject, the second week and last 7 consecutive days are the same if the subject has recorded measurements for the entire 14 day treatment period. However, for subjects reporting anything less than 14 days the two will not be identical. For all three 7 day time periods, days when a subject did not call in (i.e., missing values) were imputed as a day with heartburn.|From randomisation to day 14|||Participants|||Number
697087|NCT01370525|Secondary|Comparison of Number of Subjects With 0, 1, 2, 3 or 4 Days With no Heartburn Over Days 1 to 4 Between Esomeprazole 20 mg and Placebo|The first 4 consecutive days subjects were on randomized treatment, between V3 and V4.|From randomisation to the day 14|Full Analysis Set||Participants|||Number
697088|NCT01370525|Secondary|Number of Subjects Reporting Heartburn 2 Days or Less During the 14 Days Randomized Treatment Period|Randomized treatment period is considered as both weeks 1 and 2 between V3 and V4.|From randomisation to day 14|Full Analysis Set||Participants|||Number
697089|NCT01370525|Primary|Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment||From randomisation to day 14|Full analysis set||Percentage||Standard Deviation|Mean
697090|NCT01370460|Secondary|Postoperative Transfusion Rate|Number of patients with symptomatic (tachycardia, hypotension, presyncope) anemia of < 8.0g/dL hemoglobin, or any hemoglobin <7.0 g/dL, precipitated transfusion.|participants will be followed for the duration of hospital stay, an expected average of 3 days|||participants|||Number
697091|NCT01370460|Primary|Blood Loss|Preoperative and lowest postoperative hemoglobin|participants will be followed for the duration of hospital stay, an expected average of 3 days|||mL||Standard Deviation|Mean
697092|NCT01370408|Secondary|Number of Patients That Experience Treatment Failure Within the First 24 Hours|Number of patients with first emetic episode or time to administration of rescue therapy, whichever occurred first, within the first 24 hours|24 hours|||participants|||Number
697101|NCT01370369|Secondary|Pharmacokinetic Parameter : AUC0-24 Observed for DHT With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.|The data were presented using descriptive statistics for this outcome.|Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43|ITT population was used for this analysis, which comprised of all subjects who received at least one dose of the IMP. Number of subjects was less than 20 in some group(s) for AUC0-24 as parameter could not be calculated due to missing concentration for 0 and/or 24 hr.||ng*hour/dL||Standard Deviation|Mean
697102|NCT01370369|Secondary|Pharmacokinetic Parameter - Tmax for DHT With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.|The data were presented using descriptive statistics for this outcome.|Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43|ITT population was used for this analysis, which comprised of all subjects who received at least one dose of the IMP.||hour||Full Range|Median
697103|NCT01370369|Secondary|Pharmacokinetic Parameter - Cmax for Dihydrotestosterone (DHT) With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.|The data were presented using descriptive statistics for this outcome.|Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43|ITT population was used for this analysis, which comprised of all subjects who received at least one dose of the IMP.||ng/dL||Standard Deviation|Mean
697104|NCT01370369|Secondary|Pharmacokinetic Parameter : AUC0-24 Observed for Free Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.|The data were presented using descriptive statistics for this outcome.|Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43|ITT population was used for this analysis, which comprised of all subjects who received at least one dose of the IMP. Number of subjects was less than 20 in some group(s) for AUC0-24 as parameter could not be calculated due to missing concentration for 0 and/or 24 hr.||pg*hour/mL||Standard Deviation|Mean
697105|NCT01370369|Secondary|Pharmacokinetic Parameter - Tmax for Free Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.|The data were presented using descriptive statistics for this outcome.|Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43|ITT population was used for this analysis, which comprised of all subjects who received at least one dose of the IMP.||hour||Full Range|Median
697106|NCT01370369|Secondary|Pharmacokinetic Parameter - Cmax for Free Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.|The data were presented using descriptive statistics for this outcome.|Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43|ITT population was used for this analysis, which comprised of all subjects who received at least one dose of the IMP.||pg/mL||Standard Deviation|Mean
697107|NCT01370369|Secondary|Pharmacokinetic Parameter : AUC0-24 Observed for Total Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.|The data were presented using descriptive statistics for this outcome.|Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43|ITT population was used for this analysis, which comprised of all subjects who received at least one dose of the IMP. Number of subjects was less than 20 in some group(s) for AUC0-24 as parameter could not be calculated due to missing concentration for 0 and/or 24 hr.||ng*hour/dL||Standard Deviation|Mean
697108|NCT01370369|Secondary|Pharmacokinetic Parameter - Tmax for Total Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.|The data were presented using descriptive statistics for this outcome.|Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43|ITT population was used for this analysis, which comprised of all subjects who received at least one dose of the IMP.||hour||Full Range|Median
697109|NCT01370369|Secondary|Pharmacokinetic Parameter - Cmax for Total Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.|The data were presented using descriptive statistics for this outcome.|Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43|ITT population was used for this analysis, which comprised of all subjects who received at least one dose of the IMP.||ng/dL||Standard Deviation|Mean
697110|NCT01370369|Secondary|Pharmacokinetic Parameter : Area Under the Plasma Concentration Time Curve From 0 to 24 hr (AUC0-24) Observed for Total Testosterone, After an Initial Single Treatment (Testosterone) on the Abdomen, Inner Thigh and Shoulder/Upper Arm.|The data were presented using descriptive statistics for this outcome.|Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 1, 7 and 13|ITT population was used for this analysis, which comprised of all subjects who received at least one dose of the IMP. Number of subjects was less than 20 in some group(s) for AUC0-24 as parameter could not be calculated due to missing concentration for 0 hr.||ng*hour/dL||Standard Deviation|Mean
697111|NCT01370369|Secondary|Pharmacokinetic Parameter : Time of Maximum Observed Concentration (Tmax) for Total Testosterone, After an Initial Single Treatment (Testosterone) on the Abdomen, Inner Thigh, and Shoulder/Upper Arm.|The data were presented using descriptive statistics for this outcome.|Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 1, 7 and 13|ITT population was used for this analysis, which comprised of all subjects who received at least one dose of the IMP.||hour||Full Range|Median
697112|NCT01370369|Secondary|Pharmacokinetic Parameter : Maximum Concentration Observed (Cmax) for Total Testosterone, After an Initial Single Treatment (Testosterone) on the Abdomen, Inner Thigh and Shoulder/Upper Arm.|The data were presented using descriptive statistics for this outcome.|Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 1, 7 and 13|ITT population was used for this analysis, which comprised of all subjects who received at least one dose of the IMP.||ng/dL||Standard Deviation|Mean
697113|NCT01370369|Primary|Responder Rate - the Percentage of Subjects Whose Minimum Concentration Observed (Cmin) and Average Steady State Concentration (Cave) of Serum Testosterone Levels Were Between 298 and 1043 ng/dL.|Responder rate was calculated for the subjects who received 10 days of treatment with three doses of testosterone gel; 1.25 mL, 2.50 mL, and 3.75 mL, respectively. The data were presented using descriptive statistics for this outcome.|From Baseline to Day 43|ITT population was used for this analysis, which comprised of all subjects who received at least one dose of the IMP.||percentage of subjects|||Number
697339|NCT01367860|Secondary|VAS for Leg Pain - 3rd Month|Pain Score for leg pain - Visual Analog Scale (VAS) -> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome.|3rd month from surgery|||units on a scale||Standard Deviation|Mean
697114|NCT01370356|Secondary|Percentage of Participants With 4-Week Point Prevalence of Smoking Cessation|"The 4-week point prevalence of abstinence was defined as being abstinent from smoking and using tobacco products during the last 4 weeks of the study. The participant`s smoking status and other nicotine use was evaluated based on the last 4 weeks questions on the NUI and confirmed by CO expiration. Responders were defined as those, who answered no to both questions (Has the subject smoked any cigarettes (even a puff) in the last 4 weeks?; and Has the subject used any nicotine products and/or other tobacco.... in the last 4 weeks?) and whose expired CO < 10 ppm. Missing CO was imputed as negative (CO ≤ 10 ppm)."|Week 52|The Full Analysis Set was referred to as the ITT population and was defined as all randomized participants. The ITT population was the primary analysis set for the efficacy analyses in this study.||percentage of participants|||Number
697115|NCT01370356|Secondary|Percentage of Participants With 7-Day Point Prevalence of Smoking Cessation|"The 7-day point prevalence of abstinence was defined as being abstinent from smoking and using tobacco products during the last 7 days at Week 12, 24, and 52. The participant`s smoking status and other nicotine use was evaluated based on the last 7 days questions on the NUI and confirmed by CO expiration. Responders were defined as those, who answered no to both questions (Has the subject smoked any cigarettes (even a puff) in the last 7 days?; and Has the subject used any nicotine products and/or other tobacco.... in the last 7 days?) and whose expired CO < 10 ppm. Missing CO was imputed as negative (CO ≤ 10 ppm)."|Week 12, 24, and 52|The Full Analysis Set was referred to as the ITT population and was defined as all randomized participants. The ITT population was the primary analysis set for the efficacy analyses in this study.||percentage of participants|||Number
697116|NCT01370356|Secondary|Percentage of Participants With CO Confirmed Long Term CA From Smoking|Percentage of participants who remained abstinent from Week 21 to Week 52, inclusive, reporting no smoking and no use of nicotine-containing products since the last study visit or contact on the NUI and confirmed by expired CO < 10 ppm at any time point (CO measurements conducted at the clinic visits) during Weeks 21 through 52, inclusive. Missing CO was imputed as negative (CO ≤ 10 ppm).|Weeks 21 - 52|The Full Analysis Set was referred to as the ITT population and was defined as all randomized participants. The ITT population was the primary analysis set for the efficacy analyses in this study.||percentage of participants|||Number
697117|NCT01370356|Secondary|Percentage of Participants With CO Confirmed 4-Week CA From Smoking|Percentage of participants who remained abstinent from Week 21 to Week 24, inclusive, reporting no smoking and no use of nicotine-containing products since the last study visit or contact on the NUI and confirmed by expired CO < 10 ppm at any time point (CO measurements conducted at the clinic visits) during Weeks 21 through 24, inclusive. Missing CO was imputed as negative (CO ≤ 10 ppm).|Week 21 - 24|The Full Analysis Set was referred to as the ITT population and was defined as all randomized participants. The ITT population was the primary analysis set for the efficacy analyses in this study.||percentage of participants|||Number
697118|NCT01370356|Primary|Percentage of Participants With Carbon Monoxide (CO) Confirmed 10-Week Continuous Abstinence (CA) From Smoking|Percentage of participants who remained abstinent from Week 15 to Week 24, inclusive, reporting no smoking and no use of nicotine-containing products since the last study visit or contact on the Nicotine Use Inventory (NUI) and confirmed by expired CO < 10 ppm at any time point (CO measurements conducted at the clinic visits) during Weeks 15 through 24, inclusive. Missing CO was imputed as negative (CO ≤ 10 ppm).|Week 15 - 24|The Full Analysis Set was referred to as the Intent-to-Treat (ITT) population and was defined as all randomized participants. The ITT population was the primary analysis set for the efficacy analyses in this study.||percentage of participants|||Number
697119|NCT01370265|Secondary|Hyperemic Blood Pressure (mmHg)|Blood pressure was measured approximately 4 hours after arrival in the PET unit, depending on the randomization.|Day 2, approximately 4 hours after arrival in the PET unit|Analysis per protocol; one participant in each group experienced an ischemic ECG with the first stress drug, and they were withdrawn from the study. This is a per intervention presentation.||mmHg||Standard Deviation|Mean
697120|NCT01370265|Secondary|Heart Rate (Beats Per Minute (BPM))|The resting heart rate was measured approximately 35 minutes after arrival in the PET unit. The hyperemic heart rate was measured approximately 4 hours after arrival in the PET unit, depending on the randomization.|Day 2, approximately 35 minutes and approximately 4 hours after arrival in the PET unit|Analysis per protocol; one participant in each group experienced an ischemic ECG with the first stress drug, and they were withdrawn from the study. This is a per intervention presentation.||bpm||Standard Deviation|Mean
697121|NCT01370265|Secondary|Segmental CFR|CFR was calculated using the equation: hyperemic MBF/resting MBF.|Day 2, approximately 4 hours after arrival in positron emission tomography (PET) unit|Analysis per protocol, one participant in each group experienced an ischemic ECG with the first stress drug, and they were withdrawn from the study. This is a per intervention presentation.||ratio||Standard Deviation|Mean
697122|NCT01370265|Secondary|Hyperemic Segmental MBF|"Regional MBFs were calculated using commercial software (PMOD Technologies, version 2.4). After the apical and basal slices of the left ventricular myocardium were chosen, the software automatically defined 4 myocardial regions of interest (segments) in the apical planes.
The hyperemic MBF was measured approximately 4 hours after arrival in the PET unit, depending on the randomization."|Day 2, approximately 4 hours after arrival in positron emission tomography (PET) unit|Analysis per protocol; one participant in each group experienced an ischemic ECG with the first stress drug, and they were withdrawn from the study. This is a per intervention presentation.||mL/min/gm||Standard Deviation|Mean
697123|NCT01370265|Secondary|Global Cardiac Flow Rate|Cardiac Flow Rate was calculated using the equation: hyperemic MBF/resting MBF.|Day 2, approximately 4 hours after arrival in positron emission tomography (PET) unit|Analysis per protocol, one participant in each group experienced an ischemic ECG with the first stress drug, and they were withdrawn from the study. This is a per intervention presentation.||ratio||Standard Deviation|Mean
697124|NCT01370265|Secondary|Resting Global MBF and Resting Segmental MBF|"MBF is the rate of blood supplied to the myocardium, or heart muscle. Global Myocardial blood flow was calculated using commercial software (PMOD Technologies, version 2.4).
Regional MBFs were calculated using commercial software (PMOD Technologies, version 2.4). After the apical and basal slices of the left ventricular myocardium were chosen, the software automatically defined 4 myocardial regions of interest (segments) in the apical planes."|Day 2, approximately 35 minutes after arrival in positron emission tomography (PET) unit|Resting MBF was measured on all subjects prior to the interventions.||ml/min/gm||Standard Deviation|Mean
697125|NCT01370265|Primary|Global Hyperemic Myocardial Blood Flow (MBF)|"MBF is the rate of blood supplied to the myocardium, or heart muscle. Hyperemic MBF is the rate of myocardial blood flow in the heart muscle during either regadenoson or adenosine stress. Myocardial blood flow was calculated using commercial software (PMOD Technologies, version 2.4).
The Hyperemic MBF was measured approximately 4 hours after arrival in the PET unit."|Day 2, approximately 4 hours after arrival in positron emission tomography (PET) unit|Analysis per protocol; one participant in each group experienced an ischemic ECG with the first stress drug, and they were withdrawn from the study. This is a per intervention presentation.||mL/min/gm||Standard Deviation|Mean
697126|NCT01370083|Secondary|Tongue-palate Pressure Amplitude for Maximum Isometric Pressures|We will measure the amplitude of peak tongue-pressure amplitudes on maximum isometric pressure tasks performed using the Iowa Oral Performance Instrument. The maximum amplitude across a series of 3 maximum isometric pressure tasks performed with the bulb in a posterior position (flat end aligned with the first molar tooth) will be used to document tongue strength.|Post-treatment value|Individuals with complete pre and post-treatment data available||Kilopascals||Standard Deviation|Mean
697127|NCT01370083|Secondary|Penetration-Aspiration Scale Score for 5 cc Thin Liquid Swallows|The Penetration-Aspiration Scale is an 8-point ordinal scale that addresses the depth of airway invasion and response to airway invasion during swallowing. We will measure penetration-aspiration for a series of 3 X 5 cc thin liquid swallows in videofluoroscopy. The participant's worst score will be taken to reflect their swallowing safety. This score will be collapsed into a binary score < vs. > 3 on the scale, reflecting material entering and remaining in or below the supraglottic space (versus transient entry or no entry at all).|Post-treatment (12 weeks)|Participants with complete pre and post-treatment videofluoroscopy data available.||participants|||Number
697128|NCT01370083|Primary|Change in Swallow Response Time for 5 cc Thin Liquid Swallows|Swallow response time (the time duration between bolus passing the ramus of the shadow of the mandible and onset of hyolaryngeal excursion for airway protection 5cc thin liquid barium boluses in videofluoroscopy. Measures > 350 ms are considered to reflect impairment and a heightened risk of penetration-aspiration. The participant's mean swallow response time will be calculated across a series of 3 X 5 cc swallows and then reduced to a binary score < vs > 350 milliseconds.|Post treatment (12 weeks)|||participants|||Number
697129|NCT01370005|Other Pre-specified|Confirmed Hypoglycaemic Adverse Events|Number of participants with confirmed hypoglycaemic adverse events|From drug administration until last drug administration plus seven days, up to 171 days|Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken.||participants|||Number
697130|NCT01370005|Secondary|Orthostatic Blood Pressure|Orthostatic blood pressure (BP) at baseline and after 12 weeks of treatment.|Baseline and 12 weeks|Treated set for patients with available measurements at baseline and week 12. Treatment assignment as first medication taken.||participants|||Number
697131|NCT01370005|Secondary|Composite Endpoint of Change From Baseline of HbA1c, Systolic Blood Pressure and Body Weight|A composite endpoint of the following conditions at week 12 compared to baseline (all 3 fulfilled): reduction of HbA1c from baseline of at least 0.5%, reduction of systolic blood pressure > 3 mmHg from baseline and reduction of weight from baseline > 2%|Baseline and 12 weeks|"Patients in the full analysis set (FAS). Treatment assignment as randomised.
Non-completers (missing data due to early discontinuation, values after start of rescue medication or changes in antihypertensive therapy) considered 'failure' was used as the imputation rule."||participants|||Number
697132|NCT01370005|Secondary|Proportion of Patients Reaching Blood Pressure <130/80 mmHg|Proportion of patients reaching blood pressure <130/80 mmHg after 12 weeks of treatment|Baseline and 12 weeks|"Patients in the FAS without blood pressure control at baseline. Blood pressure control is defined as DBP<80 mmHg and SBP <130 mmHg. Treatment assignment as randomised.
Non-completers (missing data due to early disc, values after start of rescue medication or changes in antihyp. therapy) considered 'failure' was used as the imputation rule."||participants|||Number
697133|NCT01370005|Secondary|Trough Mean Seated Diastolic Blood Pressure (DBP) Change From Baseline|Change from baseline in trough mean seated DBP after 12 weeks of treatment.|Baseline and 12 weeks|"FAS which included all randomised and treated patients who had a baseline HbA1c value and a baseline mean 24-h systolic blood pressure (SBP) value. Treatment assignment as randomised.
Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and LOCF was used for imputation of missing values."||mmHg||Standard Deviation|Mean
697134|NCT01370005|Secondary|Trough Mean Seated Systolic Blood Pressure (SBP) Change From Baseline|Change from baseline in Trough Mean Seated SBP after 12 weeks of treatment.|Baseline and 12 weeks|"FAS which included all randomised and treated patients who had a baseline HbA1c value and a baseline mean 24-h systolic blood pressure (SBP) value. Treatment assignment as randomised.
Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and LOCF was used for imputation of missing values."||mmHg||Standard Deviation|Mean
697135|NCT01370005|Secondary|Nighttime Mean Diastolic Blood Pressure (DBP) Change From Baseline|Change from baseline in nighttime mean DBP after 12 weeks of treatment.|Baseline and 12 weeks|"FAS which included all randomised and treated patients who had a baseline HbA1c value and a baseline mean 24-h systolic blood pressure (SBP) value. Treatment assignment as randomised.
Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and LOCF was used for imputation of missing values."||mmHg||Standard Deviation|Mean
697136|NCT01370005|Secondary|Nighttime Mean Systolic Blood Pressure (SBP) Change From Baseline|Change from baseline in nighttime mean SBP after 12 weeks of treatment.|Baseline and 12 weeks|"FAS which included all randomised and treated patients who had a baseline HbA1c value and a baseline mean 24-h systolic blood pressure (SBP) value. Treatment assignment as randomised.
Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and LOCF was used for imputation of missing values."||mmHg||Standard Deviation|Mean
697137|NCT01370005|Secondary|Daytime Mean Diastolic Blood Pressure (DBP) Change From Baseline|Change from baseline in daytime mean DBP after 12 weeks of treatment.|Baseline and 12 weeks|"FAS which included all randomised and treated patients who had a baseline HbA1c value and a baseline mean 24-h systolic blood pressure (SBP) value. Treatment assignment as randomised.
Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and LOCF was used for imputation of missing values."||mmHg||Standard Deviation|Mean
697138|NCT01370005|Secondary|Daytime Mean Systolic Blood Pressure (SBP) Change From Baseline|Change from baseline in daytime mean SBP after 12 weeks of treatment.|Baseline and 12 weeks|"FAS which included all randomised and treated patients who had a baseline HbA1c value and a baseline mean 24-h systolic blood pressure (SBP) value. Treatment assignment as randomised.
Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and LOCF was used for imputation of missing values."||mmHg||Standard Deviation|Mean
697139|NCT01370005|Secondary|Body Weight Change From Baseline|Change from baseline in body weight after 12 weeks of treatment.|Baseline and 12 weeks|"Full analysis set (FAS) which included all randomised and treated patients who had a baseline HbA1c value and a baseline mean 24-h systolic blood pressure (SBP) value. Treatment assignment as randomised.
Values after start of antidiabetic rescue therapy were set to missing and LOCF was used for imputation of missing values."||kg||Standard Deviation|Mean
697140|NCT01370005|Secondary|Fasting Plasma Glucose (FPG) Change From Baseline|Change from baseline in FPG after 12 weeks of treatment.|Baseline and 12 weeks|"Full analysis set (FAS) which included all randomised and treated patients who had a baseline HbA1c value and a baseline mean 24-h systolic blood pressure (SBP) value. Treatment assignment as randomised.
Values after start of antidiabetic rescue therapy were set to missing and LOCF was used for imputation of missing values."||mg/dL||Standard Deviation|Mean
697141|NCT01370005|Secondary|Proportion of Patients With HbA1c <7%|Proportion of patients with HbA1c <7% after 12 weeks.|Baseline and 12 weeks|"Patients in the full analysis set (FAS) and with baseline HbA1c >= 7%. Treatment assignment as randomised.
Non-completers (missing data due to early discontinuation or values after start of rescue medication) considered 'failure' was used as the imputation rule."||participants|||Number
697142|NCT01370005|Secondary|Mean 24-hour Diastolic Blood Pressure Change From Baseline|Change from baseline in mean 24-hour diastolic blood pressure (DBP) after 12 weeks.|Baseline and 12 weeks|"FAS which included all randomised and treated patients who had a baseline HbA1c and a baseline mean 24-h systolic blood pressure value. Treatment assignment as randomised.
Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and LOCF was used for imputation of missing values."||mmHg||Standard Deviation|Mean
697143|NCT01370005|Primary|Mean 24-hour Systolic Blood Pressure Change From Baseline|Change from baseline of mean 24-hour systolic blood pressure (SBP).|Baseline and 12 weeks|"FAS, which included all randomised and treated patients who had a baseline HbA1c and a baseline mean 24-h systolic blood pressure value. Treatment assignment as randomised.
Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and LOCF was used for imputation of missing values."||mmHg||Standard Deviation|Mean
697144|NCT01370005|Primary|HbA1c Change From Baseline|Change from baseline in HbA1c after 12 weeks of treatment.|Baseline and 12 weeks|"Full analysis set (FAS), which included all randomised and treated patients who had a baseline HbA1c and a baseline mean 24-h systolic blood pressure value. Treatment assignment as randomised.
Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values."||percentage of HbA1c||Standard Deviation|Mean
697145|NCT01369888|Primary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|8 months, 9 days|||participants|||Number
697146|NCT01369888|Primary|Phase 1: Maximum Tolerated Dose (MTD) of Intravenous Recombinant IL-15 as a Daily Intravenous Bolus for 10 Consecutive Days in Patients With Metastatic Melanoma Who Have Received a Lymphodepleting Chemotherapy and ACT TIL.|Intravenous recombinant IL-15 as a daily intravenous bolus for 10 consecutive days in patients with metastatic melanoma who have received a lymphodepleting chemotherapy and ACT TIL with dose escalation (i.e., dose level 1: 0.25 mcg, dose level 2: 0.50 mcg, dose level 3: 1 mcg, and dose level 4: 2 mcg) to further characterize the safety of the MTD prior to starting the phase 2 portion.|2 years|||mcg/kg/day|||Number
697147|NCT01369875|Secondary|Toxicity|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|3 years|||Participants|||Number
697148|NCT01369875|Primary|Clinical Tumor Regression.|Clinical tumor regression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is a disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progression (PD) is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum LD.|3 years|||Participants|||Number
697149|NCT01369849|Secondary|Treatment-free Survival|Treatment free survival is defined to be the time from registration to the date of initation of subsequent therapy or death. The distribution of treatment free survival will be estimated using the method of Kaplan-Meier.|Time from registration to the date of initiation of subsequent therapy or death, median follow-up time is 37 months|All patients that were treated and evaluable were included in this endpoint.||months||95% Confidence Interval|Median
697150|NCT01369849|Secondary|Overall Response Rate|The Overall response rate is estimated by the total number of complete or partial responses (CR, CRi, CCR, nPR, or PR) divided by the total number of evaluate patients. Complete and partial responses were scored using the NCI Working Group criteria. A Complete Response (CR, CRi, and CCR) is characterized by an absence of lymphadenopathy, heptomegaly and splenomegaly with or without normalized blood counts and bone marrow assessment . A PR is defined as having >50% decrease in lymphocyte count and reduction in sum of the products of measured nodes and an improvement in blood counts. Exact binomial 95% confidence intervals for the true overall response rate will be calculated.|3 months post-treatment|All patients that were treated and evaluable for response were included together in this endpoint.||proportion of patients||95% Confidence Interval|Number
697151|NCT01369849|Secondary|Minimal-residual Disease|Minimal residual disease (MRD) will be evaluated after treatment in patients who achieve a complete clinical response. Flow cytometry will be used to detect approximately 1 CLL cell per 10,000 leukocytes following induction. A score of positive means CLL cells were found and a negative score means no CLL cells were found. The number of patients with an MRD negative score are reported here.|Cycle 6 assessment (maximum of 231 days post-registration)|5 patients achieved a complete response and were analyzed for MRD||Participants|||Count of Participants
697152|NCT01369849|Secondary|Duration of Response|Duration of response is defined for all evaluable patients who have achieved a clinical response as the date at which the patient’s objective status is first noted to be a CR, CRi, CCR, nPR, or PR to the earliest date progression is documented. The distribution of duration of response will be estimated using the method of Kaplan-Meier.|Median follow-up of 39 months and maximum follow-up of 54 months|12 patients achieved a response and were included in this analysis.||months||95% Confidence Interval|Median
697153|NCT01369849|Secondary|Fluorescent in Situ Hybridization (FISH) Biomarker Analysis|Fluorescent in situ hybridization (FISH) is a molecular cytogenetic technique that uses fluorescent probes that bind to only those parts of the chromosome with a high degree of sequence complementarity. It was developed by biomedical researchers in the early 1980s and is used to detect and localize the presence or absence of specific DNA sequences on chromosomes. In this disease group, there are recognized patterns of DNA sequences that play a role in prognostic outcomes. Patterns named 11q-, 13q-, Trisomy 12 may lead to different responses to treatments. Here we report the number of patients with each FISH prognosis evaluated pre-treatment. These factors will be summarized and used to help characterize the types of patients accrued to this trial.|Baseline|All patients that started treatment and had baseline biomarkers completed were included in this analysis. One of the 4 patients accrued to dose level 2 was not eligible for this endpoint. Therefore, 6 patients at Dose Level 1 and 3 patients at Dose Level 2 and 4 patients accrued to the Phase II portion of the study are included in this endpoint.||Participants|||Count of Participants
697154|NCT01369849|Secondary|Biomarker Analysis (CD38, CD49d, and ZAP-70)|CD38, CD49d, and ZAP-70 status will be evaluated pre-treatment. These factors will be summarized and used to help characterize the types of patients accrued to this trial.|Baseline|All patients that started treatment and had baseline biomarkers completed were included in this analysis. One of the 4 patients accrued to dose level 2 was not eligible for this endpoint. Therefore, 6 patients at Dose Level 1 and 3 patients at Dose Level 2 and 4 patients accrued to the Phase II portion of the study are included in this endpoint.||Participants|||Count of Participants
697155|NCT01369849|Secondary|Biomarker Analysis (IgVH Gene Mutation)|IgVH gene mutationwill be evaluated pre-treatment. This factors will be summarized and used to help characterize the types of patients accrued to this trial.|Baseline|All patients that started treatment and had baseline biomarkers completed were included in this analysis. One of the 4 patients accrued to dose level 2 was not eligible for this endpoint. Therefore, 6 patients at Dose Level 1 and 3 patients at Dose Level 2 and 4 patients accrued to the Phase II portion of the study are included in this endpoint.||Participants|||Count of Participants
697156|NCT01369849|Primary|Proportion of Complete Response Defined to be a CR or CRi Noted as the Objective Status (Phase II)|"A Complete Response (CR) is defined by the NCI Working Group criteria and requires all of the following for a period of at least 2 months:
Absence of lymphadenopathy (e.g. lymph nodes >1.5 cm) by physical examination.
No hepatomegaly or splenomegaly by physical examination.
Absence of constitutional symptoms.
Neutrophils ≥1500/ul.
Platelets >100,000/ul (untransfused).
Hemoglobin >11.0 gm/dl (untransfused)
Peripheral blood lymphocytes <4000/uL
Patients who fulfill all criteria for a CR but who have a persistent anemia, thrombocytopenia, or neutropenia related to drug toxicity rather than residual CLL will be classified as CR with incomplete marrow recovery (CRi).
The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner."|From registration to response, up to 84 days|All eligible patients treated at Dose Level 1 were included in the Phase II primary endpoint. All 6 patients from Phase I, Dose level 1 and 4 of the 5 patients registered to the Phase II portion of the study were eligible for this endpoint.||percentage of participants||95% Confidence Interval|Number
697157|NCT01369849|Primary|Number of Phase I Participants With Dose-Limiting Toxicity Events (Phase I)|The Maximum Tolerated Dose (MTD) is defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Dose-limiting toxicities include non-hematologic events graded 3 or higher and deemed at least possibly related to treatment. A total of 6 patients treated at the MTD will be sufficient to identify common toxicities at the MTD.The number of patients reporting a dose-limiting event are reported.|Up to 35 days|Only the patients registered to the Phase I portion of this study were analyzed for this endpoint. One of the 4 patients accrued to dose level 2 was not eligible for this endpoint. Therefore, 6 patients at Dose Level 1 and 3 patients at Dose Level 2 are included in this endpoint.||Patients reporting Dose-Limiting Events|||Number
697158|NCT01369784|Post-Hoc|Relationship Between Global Response Rate to 2nd Line of Treatment and Beta-2 Microglobulin at Relapse|Global response rate was assessed using the National Cancer Institute-sponsored Working Group guidelines. Responses are: complete response, partial response, stable disease, progression and relapse|At relapse|||mg/100ml||Standard Deviation|Mean
697159|NCT01369784|Post-Hoc|Relationship Between Global Response Rate to 2nd Line of Treatment and Lymphocyte/Monocyte Rate on Relapse|Global response rate was assessed using the National Cancer Institute-sponsored Working Group guidelines. Responses are: complete response, partial response, stable disease, progression and relapse|At relapse|||participants|||Number
697160|NCT01369784|Post-Hoc|Relationship Between Global Response Rate to 2nd Line of Treatment and Absolute Lymphocyte Count on Relapse|Global response rate was assessed using the National Cancer Institute-sponsored Working Group guidelines. Responses are: complete response, partial response, stable disease, progression and relapse|At relapse|||participants|||Number
697161|NCT01369784|Secondary|Relationship Between Global Response Rate to 2nd Line of Treatment and Multiple Myeloma Oncogene 1 (MUM1) Expression at Diagnosis|Global response rate was assessed using the National Cancer Institute-sponsored Working Group guidelines. Responses are: complete response, partial response, stable disease, progression and relapse|At diagnosis|||participants|||Number
697162|NCT01369784|Secondary|Relationship Between Global Response Rate to 2nd Line of Treatment and p53 Expression at Diagnosis|Global response rate was assessed using the National Cancer Institute-sponsored Working Group guidelines. Responses are: complete response, partial response, stable disease, progression and relapse|At diagnosis|||participants|||Number
697163|NCT01369784|Secondary|Relationship Between Global Response Rate to 2nd Line of Treatment and Bcl-6 Expression at Diagnosis|Global response rate was assessed using the National Cancer Institute-sponsored Working Group guidelines. Responses are: complete response, partial response, stable disease, progression and relapse|At diagnosis|||participants|||Number
697166|NCT01369784|Secondary|Response to Second Line of Treatment|"Complete Response (CR), Disappearance of all target lesions for at least 8 weeks.
Partial response (PR): At least a 50% dicrease in the sum of the products of two measurements (the maximum diameter of a tumor and the largest diameter perpendicular to this maximum diameter) of 6 biggest individual tumors. Not increased of measure of other tumors, spleen or liver Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Progressive Disease (PD): At least a 50% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions during or at the end of the treatment."|After second line of treatment|||participants|||Number
697167|NCT01369784|Secondary|Response to First Line of Treatment|"Complete Response (CR), Disappearance of all target lesions for at least 8 weeks.
Partial response (PR): At least a 50% dicrease in the sum of the products of two measurements (the maximum diameter of a tumor and the largest diameter perpendicular to this maximum diameter) of 6 biggest individual tumors. Not increased of measure of other tumors, spleen or liver Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Progressive Disease (PD): At least a 50% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions during or at the end of the treatment."|After first line treatment|||participants|||Number
697168|NCT01369784|Secondary|Ann Arbor Staging|Ann Arbor=I: Best condition Ann Arbor=IV: Worst condition|At the beginning of the 2nd line of treatment|||percentage of patients|||Number
697169|NCT01369784|Secondary|Eastern Cooperative Oncology Group Performance Status (ECOG) Performance Status|ECOG=0: Fully active, able to carry on all pre-disease performance without restriction ECOG=5: Exitus|At the beginning of the 2nd line of treatment|||participants|||Number
697170|NCT01369784|Secondary|MUM-1 Expression|immunohistochemical reaction of cells with MUM-1 antibody|At the beginning of the 2nd line of treatment|||percentage of participants|||Number
697171|NCT01369784|Secondary|Multiple Myeloma Oncogene 1 (MUM-1) Expression|immunohistochemical reaction of cells with MUM-1 antibody|At diagnosis|||percentage of participants|||Number
697172|NCT01369784|Secondary|p53 Expression|immunohistochemical reaction of cells with p-53 antibody|At the beginning of the 2nd line of treatment|||percentage of participants|||Number
697173|NCT01369784|Secondary|p-53 Expression|immunohistochemical reaction of cells with p-53 antibody|At diagnosis|||percentage of participants|||Number
697174|NCT01369784|Primary|R-IPI Index (Revised International Prognostic Index)|The IPI is based on the evaluation of 5 clinical factors: age > 60 years Ann Arbor stage III or IV disease > 1 extra nodal site European Cooperative Oncology Group performance status (ECOG PS) _ 2, increased serum LDH (lactate dehydrogenase) levels Revised IPI (R-IPI) evaluates the same parameters, but groups them differently to form 3 prognostic groups of patients with significantly different progression-free survival and overall survival outcomes.|At the beginning of the 2nd line of treatment, an average of 2 years|||percentage of patients|||Number
697175|NCT01369784|Secondary|Bcl-6 Expression|immunohistochemical reaction of cells with Bcl-6 antibody|At the beginning of the second line of treatment|||percentage of participants|||Number
697176|NCT01369784|Secondary|Bcl-6 Expression|immunohistochemical reaction of cells with Bcl-6 antibody|At diagnosis|||participants|||Number
697177|NCT01369784|Secondary|Bcl-2 Expression|immunohistochemical reaction of cells with Bcl-2 antibody|At the beginning of the 2nd line of treatment|||participants|||Number
697178|NCT01369784|Secondary|Bcl-2 Expression|immunohistochemical reaction of cells with Bcl-2 antibody|At diagnosis|||percentage of participants|||Number
697179|NCT01369784|Primary|R-IPI Index (Revised International Prognostic Index)|Data will be recorded from diagnosis to second line response, an expected average of 7 months|At diagnoses|||percentage of participants|||Number
697180|NCT01369758|Secondary|Percentage of Subjects That Achieve 100% Removal of Target Pathology|Percentage of subjects that achieve 100% removal of target pathology, as determined by hysteroscopic exam following the treatment procedures.|1 hour post treatment|||percentage of participants||95% Confidence Interval|Number
697181|NCT01369758|Primary|Procedure Efficacy|Mean percent of pathology removed, based on hysteroscopic assessment immediately following completion of the treatment procedure|1 hour post treatment|559 pathologies, 187 Fibroids and 372 polyps, were removed from 278 patients.||percent of pathology||95% Confidence Interval|Mean
697182|NCT01369745|Secondary|Time to Failure (Days)|Patients will be monitored for addition of any DMARD or withdrawal due to flare. The time to failure is defined as the duration of study participation (in days) until a qualifying event or completion of study treatment, whichever comes first.|Baseline to 12 weeks|Because the study never progressed past the first stage of the adaptive randomization, the number of subjects who were allocated to the dipyridamole 360 mg, prednisolone 2.7 mg, and prednisone 5 mg treatment arms was insufficient (underpowered) to allow analysis of the secondary objectives.|||||
697183|NCT01369745|Secondary|Multidimensional Assessment of Fatigue (MAF) at Week 12|"The Multidimensional Assessment of Fatigue (MAF) scale contains 16 items and measures four dimensions of fatigue: severity (#1-2), distress (#3), degree of interference in activities of daily living (#4-14), and timing (#15-16). Fourteen items contain numerical rating scales (#1-14) and two items have multiple-choice responses (#15-16). Respondents are asked to reflect on fatigue patterns for the past week.
To calculate the Global Fatigue Index (GFI): Convert item #15 to a 0-10 scale by multiplying each score by 2.5 and then sum items #1, 2, 3, average #4-14, and newly scored item #15.
Scores range from 1 (no fatigue) to 50 (severe fatigue). Do not assign a score to items #4-14 if respondent indicated they do not do any activity for reasons other than fatigue. If respondents select no fatigue on item #1, assign a zero to items #2-16. Item #16 is not included in the Global Fatigue Index."|week 12|Because the study never progressed past the first stage of the adaptive randomization, the number of subjects who were allocated to the dipyridamole 360 mg, prednisolone 2.7 mg, and prednisone 5 mg treatment arms was insufficient (underpowered) to allow analysis of the secondary objectives.|||||
697340|NCT01367860|Secondary|VAS for Leg Pain - 1st Month|Pain Score for leg pain - Visual Analog Scale (VAS) -> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome.|1st month from surgery|||units on a scale||Standard Deviation|Mean
697184|NCT01369745|Secondary|Percentage of Subjects Achieving ACR20, ACR50 and ACR70 at 12 Weeks|The American College of Rheumatology (ACR) 20 is a widely accepted composite index of improvement in RA proposed by the ACR (Fransen and van Riel 2009). ACR20 refers to a composite improvement of 20% in swollen joint count, tender joint count, and 3 or more of the following 5 measures:Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, Patient Pain VAS, Patient's self-addressed disability (HAQ) (Arnet 1988 and Felson 1995), Acute-phase reactant (ESR or CRP) The ACR 50 and ACR 70 are similar tools, used to indicate 50% and 70% improvement, respectively.|Week 12|Because the study never progressed past the first stage of the adaptive randomization, the number of subjects who were allocated to the dipyridamole 360 mg, prednisolone 2.7 mg, and prednisone 5 mg treatment arms was insufficient (underpowered) to allow analysis of the secondary objectives.|||||
697185|NCT01369745|Secondary|Change From Baseline in DAS28-CRP Individual Components at 12 Weeks|"The mean change in the individual components of the Disease Activity Score 28 using C-reactive protein (DAS28-CRP) from baseline to Week 12 which included individual assessment of Tender Joint Count (28-joint assessment), Swollen Joint Count (28-joint assessment), Patient Global Assessment of Disease Activity and absolute CRP level. In each case, higher scores indicate more disease activity.
The DAS28-CRP is a composite measure of inflammation in Rheumatoid Arthritis and incorporates a tender and swollen joint count, CRP and Patient Global Assessment of Disease Activity expressed in a Gaussian distribution of variables ranging from 0 to 10. A DAS28-CRP score of <3.2 suggests a low level of disease activity, while a score of >5.1 suggests a high level of disease activity."|Baseline to week 12|Because the study never progressed past the first stage of the adaptive randomization, the number of subjects who were allocated to the dipyridamole 360 mg, prednisolone 2.7 mg, and prednisone 5 mg treatment arms was insufficient (underpowered) to allow analysis of the secondary objectives.|||||
697186|NCT01369745|Primary|Change From Baseline in DAS28-CRP at 12 Weeks|"The primary efficacy endpoint was the mean change in Disease Activity Score 28 using C-reactive protein (DAS28-CRP) from baseline to Week 12.
The DAS28-CRP is a composite measure of inflammation in Rheumatoid Arthritis and incorporates a tender and swollen joint count, CRP and Patient Global Assessment of Disease Activity expressed in a Gaussian distribution of variables ranging from 0 to 10. A DAS28-CRP score of <3.2 suggests a low level of disease activity, while a score of >5.1 suggests a high level of disease activity. Using the DAS-CRP as a continuous scale allows investigators (and clinicians) to measure a clinically meaningful endpoint following institution of a therapeutic intervention. In RA, clinical remission would therefore be graded as a DAS28 score of ≤3.2 with disease flare accompanying scores of ≥5.1; well-controlled disease is best characterized as fitting in between these two scores."|baseline to week 12|The efficacy analysis population includes all 252 subjects who received at least one dose of study drug after randomization and who provided at least one post-baseline measurement of the primary endpoint||units on a scale||Standard Deviation|Mean
697187|NCT01369732|Primary|Incidence of Acute Kidney Injury Based on RIFLE Criteria||upto 7 days after surgery|||participants|||Number
697188|NCT01369732|Secondary|the Duration of Hospital Stay|Participants will be followed for the duration of hospital stay, an expected average of 1 month after surgery.|upto 1 month after surgery||||||
697189|NCT01369732|Secondary|the Duration of ICU Stay|Participants will be followed for the duration of ICU stay, an expected average of 2 weeks after surgery.|upto 2 weeks after surgery||||||
697190|NCT01369732|Secondary|the Duration of Mechanical Ventilation|Participants will be followed for the duration of mechanical ventilation, an expected average of 2 weeks after surgery.|upto 2 weeks after surgery||||||
697191|NCT01369732|Secondary|Mortality|Participants will be followed for the mortality, an expected average of 1 month after surgery.|upto 1 month after surgery||||||
697192|NCT01369732|Primary|Incidence of Acute Kidney Injury Based on RIFLE Criteria|Serum creatinine, GFR, urine output will be measured at 6:00 AM everyday up to 7 days after surgery.|upto 7 days after surgery||||||
697193|NCT01369706|Primary|Electromagnetic Interference|inhibition of the pacemaker, loss of capture, inappropriate mode switch, ventricular oversensing, power-on-reset, device reprogramming or loss of function|time during exposure to hand-held metal detector (2x 30 sec)|Electromagnetic interference||participants|||Number
697194|NCT01369680|Secondary|Pain Control|"Subjects will be assessed for clinically significant change in pain scores during and after study drug administration. Significant change in pain scores were determined at week 2, though week 14 scores were collected as well.
Participants with a 2 point (or greater) decrease in pain scores compared to baseline were considered to have responded. The NRS scale was used, the scale ranges from 0-10, with 10 being the most pain."|Week 2|Number of participants for analysis was determined in negotiation with the FDA for safety of all participants.||participants|||Number
697195|NCT01369680|Secondary|Norketamine Cmax (Measured in ng/mL).|Pharmacokinetic testing will be done during chronic ketamine administration on subjects consenting to additional testing one week into study drug administration. This is to further describe the activity of ketamine in the blood of children when administered chronically and to enable comparison of any clinical effect or toxicity with steady state levels of ketamine in children.|At week 1|All participants consenting for pharmacokinetics were analyzed. No participants in ketamine 1.5 mg/kg/dose group consented for pharmacokinetics.||ng/mL||Full Range|Mean
697196|NCT01369680|Secondary|Neurocognitive Effect|"Baseline neurocognitive testing will be done before study drug is given. Subjects will be reassessed for any changes in neurocognitive scores at end of dosing (week 2) and at three weeks off study drug (week 14). Significant changes were measured at week 14 compared to baseline. Week 2 was measured to inform future studies.
The neurocognitive scores are standardized scores with a mean of 100; low scores correlate with low neurocognitive function, while high scores correlate with high function. A significant change is defined as greater than or equal to 10% decrease in scores."|At 14 weeks|All participants not lost to follow-up were analyzed||participants|||Number
697197|NCT01369680|Primary|Number of Participants Tolerating Dose|According to CTCae any dose causing grade 2 or worse toxicity will be an untolerated dose. Tolerability is defined as ability to take the medication for 2 weeks without having a grade 2 or worse toxicity.|Up to 2 weeks|Number of participants was determined through negotiation with the FDA for safety of all participants.||participants|||Number
697341|NCT01367860|Secondary|VAS for Leg Pain - 1st Week|Pain Score for leg pain- Visual Analog Scale (VAS) -> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome.|1st week from surgery|||units on a scale||Standard Deviation|Mean
697199|NCT01369615|Primary|The Number of Participants With Adverse Events as a Measure of Safety.|Safety assessments included adverse events (AEs), vital sign measurements, clinical laboratory test results, and somnolence (University of Michigan Sedation Scale [UMSS]). Safety variables were summarized descriptively within age group for the extension safety population.|Up to 6 months (during the study) and 7-10 days poststudy (safety follow-up assessment).|The extension safety population was the group of patients who received at least 1 dose of study drug during the Extension Study.||participants|||Number
697200|NCT01369485|Primary|Evaluate the Median Change From Baseline in Mean Urgency (Urinary) Incontinence Episodes (Leaks) Between the Active and Sham Treatment Groups|"The primary objective of the randomized phase of the study is to evaluate the 12 week and 12 month median change from baseline in mean urgency (urinary) incontinence episodes (leaks) between treatment groups. The mean of the number of urinary incontinence episodes over 24 hours” is defined as the mean of the number of UIEs recorded per 24 hour period for three consecutive days (via a 3-day diary).
Mean urinary frequency episodes calculated for each patient during time period. The median change in frequency was then calculated for each treatment group. Distribution of changes from baseline were then assessed prospectively for normality using the Kolmogorov – Smirnoff test. Since departure from normality was actually observed in the distribution, the Wilcoxon Rank-Sum test was performed to compare the median change between treatment groups and the p-values for the test of equality of medians were reported along with the medians."|12 weeks (Randomized Phase) and 12 Months (Open Label)|||Episodes/day||Inter-Quartile Range|Median
697201|NCT01369485|Secondary|Change Clinical Global Impressions at 12 Weeks|"CGI is an Investigator assessment, which rates the severity of illness at baseline on a scale of 1 (normal, not ill at all) to 7 (Amongst the most extremely ill patients), and then rates improvement at 12 weeks on a scale of 1 (very much improved) to 10 (very much worse). The analysis was based upon the number of patients that much and very much improved."|12 weeks (Randomized Phase) and 12 Months (Open Label Phase)|Intent to treat||% patients much or very much improved|||Number
697202|NCT01369485|Secondary|Assessment of Improvement as Measure by Overactive Bladder Satisfaction With Treatment Questionnaire (OAB-SAT)|Overall satisfaction with treatment was assessed (OAB-SAT-q) an 11 question list with multiple scaled checkboxes to allow the subject to rate the treatment with regard to satisfaction, bother from side effects, treatment endorsement, and convenience.|12 weeks|Intent to treat population for those who had prior treatment for OAB.||percentage of patient prefer treatment|||Number
697203|NCT01369485|Secondary|Assessment of Treatment Benefit Scale (TBS)|TBS is a patient-reported outcome comprised of a 4-point scale of checkboxes to describe the change in condition during treatment (greatly improved to worsened). Improvement was defined as a change in the patient's assessment of overall condition to improved or greatly improved over the course of treatment. Analysis was based upon the number of patients who reported an improvement in condition.|12 Weeks|Intent to Treat||percentage patients improved (responded)|||Number
697204|NCT01369485|Secondary|Change in Patient Perception of Bladder Condition (PPBC) From Baseline (Screening Period) to Week 12 as Defined as an Improvement in Severity.|PPBC is a 6-point scale (from 'no problems at all' to ‘many severe problems’) describing the problem level of the bladder condition at that moment. Improvement is defined as a reduction in the number and/or severity of observed problems.|12 Weeks (Randomized Phase) and 12 Months (Open Label Phase)|Intent to Treat||percentage of patients that improved|||Number
697205|NCT01369485|Secondary|Change in Median Total Health Related Quality of Life (HRQL) of OAB-q From Baseline (Screening) to Week 12|The OAB-q is validated to measure symptom bother and life impact due to OAB. It consists of an 8-item Bother Scale to assess individual symptoms and a 25-item HRQL scale that in turn consists of 4 subscales (coping-8 items, concern-7 items, sleep-5 items and social-5 items) to assess impact on life. Responses for each item in the Bother Scale range from 1 (bothered not at all by the symptom) to 6 (Bothered A Very Great Deal). Scores are then added generating an overall Bother Score (severity) ranging from 8 to 48. For HRQL, individual responses range between 1-None of the Time to a 6-All of the Time. Subscale scores range from 8-48 (coping) 7-42 (concern), 5-30 (sleep) and 5-30 (social). Subscale scores are then added to generate the HRQL ranging between 25-150. Raw HRQL scores are transformed for standardization purposes as follows: ((Highest Possible Score-Actual Raw Score)/Range of Scores)*1 00 so that scores could range from 0 (All of the Time) to 100 (None of the Time).|12 Weeks (Randomized Phase) and 12 Months (Open Label).|Intent to Treat||units on a scale||Inter-Quartile Range|Median
697206|NCT01369485|Secondary|Measure Improvement in the Median of the Mean OAB-Symptom Composite Score|"OAB Symptom Composite Score (OAB-SCS) is a composite symptom score of toilet voids, urgency severity and urge urinary incontinence combining the Indevus Urgency Severity Scale (IUSS) for capture of urgency severity per toilet void with 24-hour frequency and UUI episodes.
IUSS Score/void and/or UUI is assigned an OAB-SCS Point/Void: 0(none)=1, 1(mild/easily tolerated)=2, 2(moderate discomfort interfering with activities)=3, 3(severe/extreme urgency discomfort that abruptly stopped all activity or tasks)=4, UUI without void=5.
Overall OAB-SCS Score is calculated for each day by multiplying the OAB-SCS Points/Void and/or UUIs by the number of events meeting criteria and adding the individual scores together. The minimum overall OAB-SCS score in a 24 hour period would be a 1 (representing a single mild void with a OAB –SCS Point/Void score of 0). The score would increase based upon the number voids/events and overall severity each event. Medians calculated for each treatment group."|12 weeks|||units on a scale||Inter-Quartile Range|Median
715368|NCT00252187|Secondary|Change in Blood Pressure at 8 Weeks|Blood pressure was measured during the MRI|Baseline and 8 weeks|Per protocol population||mmHg||Standard Deviation|Mean
697207|NCT01369485|Secondary|Measure Decrease in the Median Change From Baseline in Mean Urgency Episodes|"Evaluate the 12 week change from baseline in median for mean number of urgency episodes between the active and sham treatment groups.
Patients were required to complete seven 3-day voiding diaries throughout the course of the study. The voiding diary collected the following information: amount voided (in ml); urgency associated with each toileted void , approximate time of leak, and presence of urge preceding leak.The mean number of urgency episodes over 24 hours was then calculated for each patient during the observation period. The change in median for the mean of the number of urgency episodes over 24 hours) for each treatment group was then calculated.
Distribution of changes from baseline were assessed prospectively using the Kolmogorov – Smirnoff test. The Wilcoxon Rank-Sum test was performed to compare the median change between treatment groups and the p-values for the test of equality of medians were reported along with the medians."|12 weeks|||Difference in episodes/24 Hours||Inter-Quartile Range|Median
697208|NCT01369485|Secondary|Measure Median Change in Mean Volume Per Void|Evaluate the 12 week median change from baseline in mean volume (ml) per void between the active and sham treatment groups|12 weeks|||ml||Inter-Quartile Range|Median
697209|NCT01369485|Secondary|Measure Change in the Median of the Mean Urinary Frequency|"Evaluate the 12 week change from baseline in median urinary frequency between the active and sham treatment groups.
Mean urinary frequency episodes calculated for each patient during time period. The median change in frequency was then calculated for each treatment group. Distribution of changes from baseline were then assessed prospectively for normality using the Kolmogorov – Smirnoff test. Since departure from normality was actually observed in the distribution, the Wilcoxon Rank-Sum test was performed to compare the median change between treatment groups and the p-values for the test of equality of medians were reported along with the medians."|12 weeks and 12 Months|||Episodes/24 hours||Inter-Quartile Range|Median
697210|NCT01369485|Primary|Evaluate Proportion of Responders Based on the Change From Baseline in Mean Urgency (Urinary) Incontinence Episodes (Leaks) Between the Active and Sham Treatment Groups|"The primary objective of the randomized phase of the study is to evaluate the 12 week change from baseline in mean urgency (urinary) incontinence episodes (leaks) between the active and sham treatment groups. The mean of the number of urinary incontinence episodes over 24 hours” is defined as the mean of the number of UIEs recorded per 24 hour period for three consecutive days (via a 3-day diary).
The primary objective of the open label phase of the study is to evaluate and confirm the continued efficacy of the VERV™ System for long-term use. The primary objective was assessed with rate of responders, where responder was defined as a subject who achieved a decrease of ≥50% in mean urgency urinary incontinence episodes at 12 weeks compared to baseline."|12 weeks (Randomized Phase) and 12 Months (Open Label)|Intent to treat population. Responders are defined as patients who had a greater than or equal to 50% decrease in mean number urgency incontinence episodes over 24 hours.||Number of responders|||Number
697211|NCT01369355|Secondary|Number of Participants in Clinical Remission at Week 44 in the Subset of Participants Who Were Refractory or Intolerant to Tumor Necrosis Factor (TNF) Antagonist Therapy|Clinical remission at Week 44 was defined as a CDAI score of <150 points in the subset of participants who were refractory or Intolerant to tumor necrosis factor antagonist therapy.|Week 44|The primary efficacy analysis population in this study was randomized participants (ie, participants who were in clinical response to ustekinumab induction dosing at Week 8 from one of the induction studies CRD3001 and CRD3002) after study restart.||participants|||Number
697212|NCT01369355|Secondary|Number of Participants With Corticosteroid-free Remission at Week 44|Corticosteroid-free remission at Week 44 was defined as a CDAI score of <150 points without receiving corticosteroids at Week 44.|Week 44|The primary efficacy analysis population in this study was randomized participants (ie, participants who were in clinical response to ustekinumab induction dosing at Week 8 from one of the induction studies CRD3001 and CRD3002) after study restart.||participants|||Number
697213|NCT01369355|Secondary|Number of Participants in Clinical Remission at Week 44 Among Participants in Clinical Remission to Ustekinumab at Week 0 of Maintenance Study|Clinical remission at week 44 was defined as a CDAI score of < 150 points among participants in clinical remission to Ustekinumab at week 0 of maintenance study.|Week 44|Analysis population included all randomized participants after the study was restarted (who were in clinical remission at Week 0 of maintenance study). 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||participants|||Number
697214|NCT01369355|Secondary|Number of Participants With Clinical Response at Week 44|Clinical response at Week 44 was defined as a reduction from baseline in the Crohn's Disease Activity Index (CDAI) score of greater than or equal (>=) 100 points. Participants with a baseline CDAI score of > = 220 to less than or equal (< =) 248 were considered to be in clinical response if a CDAI score of less than (<) 150 was attained. A CDAI score of less than 150 indicates clinical remission. A decrease in CDAI score over time indicates improvement in disease activity.|Week 44|The primary efficacy analysis population in this study was randomized participants (ie, participants who were in clinical response to ustekinumab induction dosing at Week 8 from one of the induction studies CRD3001 and CRD3002) after study restart.||participants|||Number
697215|NCT01369355|Primary|Number of Participants With Clinical Remission at Week 44|Clinical remission at Week 44 was defined as a Crohn’s Disease Activity Index (CDAI) score of <150 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). CDAI was assessed by collecting information on 8 different Crohn’s disease-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being). A decrease in CDAI over time indicates improvement in disease activity.|Week 44|The primary efficacy analysis population in this study was randomized participants (ie, participants who were in clinical response to ustekinumab induction dosing at Week 8 from one of the induction studies CRD3001 and CRD3002) after study restart.||participants|||Number
697226|NCT01369225|Other Pre-specified|Change From Baseline in Mini-Mental State Exam (MMSE) Scores at Week 52|The MMSE is a brief 30-point questionnaire test that is used to assess cognition. Scores range from 0 to 30, with higher scores indicating better cognitive state.|Baseline, Week 52|The full analysis set included participants who were randomized and received at least 1 infusion of study medication; n=number of evaluable participants at the specified time point.||units on a scale||Standard Deviation|Mean
697227|NCT01369225|Other Pre-specified|Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) Scores at Week 52|The CDR scale is a dementia staging instrument that tracks the progression of cognitive impairment in the following 6 categories: memory, orientation, judgment and problem solving, involvement in community affairs, home and hobbies, and personal care. The CDR-SB scale is obtained by summing the ratings in each of the 6 categories, ranging from 0 to 18. Higher scores indicate greater disease severity.|Baseline, Week 52|The full analysis set included participants who were randomized and received at least 1 infusion of study medication; n=number of evaluable participants at the specified time point.||units on a scale||Standard Deviation|Mean
697228|NCT01369225|Other Pre-specified|Change From Baseline in Neuropsychiatric Inventory (NPI) Behavioral Symptoms at Week 52|The NPI is an instrument used to assess changes of behavior that have appeared in a defined period of time in subjects with Alzheimer's Disease and other dementias. Twelve behavioral areas are assessed: delusions, apathy, hallucinations, disinhibition, agitation, irritability, depression, aberrant motor behavior, anxiety, nighttime behaviors, euphoria, appetite, and eating changes. The NPI score is based on frequency and severity of specific behaviors within these categories. Severity (1=Mild to 3=Severe), frequency (1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score (range 0-12). Total score=sum of each domain score (range 0-144); higher score=greater behavioral disturbances; negative change score from baseline=improvement.|Baseline, Week 52|The full analysis set included participants who were randomized and received at least 1 infusion of study medication; n=number of evaluable participants at the specified time point.||units on a scale||Standard Deviation|Mean
697229|NCT01369225|Other Pre-specified|Change From Baseline in Disability Assessment in Dementia (DAD) at Week 52|The DAD is a functional assessment comprised of 40 items (17 items related to self-care and 23 items involving instrumental activities of daily living). The DAD assessment is scored from 0 to 100; higher scores indicate better function.|Baseline, Week 52|The full analysis set included participants who were randomized and received at least 1 infusion of study medication; n=number of evaluable participants at the specified time point.||units on a scale||Standard Deviation|Mean
697230|NCT01369225|Other Pre-specified|Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Scores at Week 52|ADAS-Cog is a structured scale that evaluates memory, orientation, attention, reasoning, language and constructional praxis. The ADAS-Cog comprises 11 items that are summed to a total score ranging from 0 to 70, with higher scores indicate greater cognitive impairment.|Baseline, Week 52|The full analysis set included participants who were randomized and received at least 1 infusion of study medication; n=number of evaluable participants at the specified time point.||units on a scale||Standard Deviation|Mean
697231|NCT01369225|Other Pre-specified|Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer|Number of participants with positive sample(s) in the ADA assay and in the neutralizing anti-drug antibodies (NAb) assay. An endpoint titer >=6.64 corresponded to positive ADA category value. The number of participants who tested positive on 1 or more occasions is reported.|Baseline, Week 52|The safety analysis set included participants who received at least 1 infusion of study medication (including partial infusions); n=number of evaluable participants at the specified time point.||participants|||Number
697232|NCT01369225|Primary|Number of Participants With Any New Magnetic Resonance Imaging (MRI) Findings|Brain MRIs were collected to assess for potential drug-related changes that might have constituted a safety concern. Findings suggestive of either vasogenic edema or intracranial hemorrhage were to be reported as AEs of special circumstance.|Baseline up to Week 52|The safety analysis set included participants who received at least 1 infusion of study medication (including partial infusions).||participants|||Number
697233|NCT01369225|Primary|Number of Participants With Suicidal Ideation or Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)|The C-SSRS captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. C-SSRS assesses whether participant experienced the following: completed suicide; suicide attempt; preparatory acts towards imminent suicidal behavior; suicidal ideation; self-injurious behavior, no suicidal intent. The results presented are the number of participants with completed suicide or non-fatal suicide events or behaviors. Worsening of suicidal ideation was an increase in severity of suicidal ideation from baseline.|Baseline up to Week 52|The safety analysis set included participants who received at least 1 infusion of study medication (including partial infusions).||participants|||Number
697234|NCT01369225|Primary|Number of Participants With Abnormal Neurological Examination Findings|Neurological examinations were done to the extent needed to assess the subject for any potential changes in neurological status, as determined by the investigator. Examinations included level of consciousness, speech, cranial nerves, motor, sensory, coordination, gait, and tendon reflexes. Only tests with at least 1 participant abnormality are reported.|Baseline up to Week 52|The safety analysis set included participants who received at least 1 infusion of study medication (including partial infusions).||participants|||Number
697235|NCT01369225|Primary|Number of Participants With Abnormal Physical Examination Findings|A full physical examination consisted of an examination of the abdomen, genitourinary and cardiovascular systems, lungs, lymph nodes, mouth, musculoskeletal and neurological systems, skin, extremities, head, ears, eyes, nose, throat and thyroid gland. Criteria for abnormal physical findings was based on the investigator's discretion and any new physical examination findings were documented as AEs. Only sites with at least 1 participant abnormality are reported.|Baseline up to Week 52|The safety analysis set included participants who received at least 1 infusion of study medication (including partial infusions).||participants|||Number
697236|NCT01369225|Primary|Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings|ECG parameters included PR interval, QRS interval, and QT interval. Criteria for ECG changes meeting potential clinical concern included: PR interval >=300 milliseconds (msec) or >=25% increase when baseline is >200 msec and >=50% increase when baseline is less than or equal to (<=)200 msec; QRS interval >=200 msec or >=50% increase from baseline when baseline is less than or equal to 100 msec and >=25% increase when baseline is >100 msec; and QTcF >=450 msec or >=30 msec increase.|Baseline up to Week 52|The safety analysis set included participants who received at least 1 infusion of study medication (including partial infusions).||participants|||Number
697237|NCT01369225|Primary|Number of Participants With Potentially Clinically Important Vital Sign Findings|Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: supine/sitting pulse rate <40 or >120 beats per minute (bpm); standing pulse rate <40 or >140 bpm; systolic blood pressure (SBP) of more than or equal to (>=)30 millimeters of mercury (mm Hg) change from baseline in same posture or SBP <90 mm Hg, diastolic blood pressure (DBP) >=20 mmHg change from baseline in same posture or DBP <50 mm Hg.|Baseline up to Week 52|The safety analysis set included participants who received at least 1 infusion of study medication (including partial infusions).||participants|||Number
697238|NCT01369225|Primary|Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern|The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell [RBC] count, RBC morphology, platelet count, white blood cell [WBC] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen [BUN], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, alkaline phosphatase, uric acid, albumin, and total protein; urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, microscopy [if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase]); others (coagulation panel, circulating immune complex, and complement activation).|Baseline up to Week 52|The safety analysis set included participants who received at least 1 infusion of study medication (including partial infusions).||participants|||Number
697239|NCT01369225|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.|Baseline up to Week 52|The safety analysis set included participants who received at least 1 infusion of study medication (including partial infusions).||participants|||Number
697242|NCT01369030|Primary|Change in Depression Severity as Measured by the 9-item Patient Health Questionnaire (PHQ-9)|"The PHQ-9 is a depression scale used to assess brief depression severity by rating symptoms and functional impairment experienced in the last two weeks. The questionnaire contains a total of 9 questions, and each question is scored on a range from 0-3. The minimum value 0 represents not at all, 1 several days, 2 indicates more than half the days, and the maximum value 3 stands for nearly every day. The total possible range is 0-27. The total number of each 0, 1, 2, 3 is added and multiplied by its value (0=0, 1=1, etc.) to produce a total score generated from the subtotal sum. The PHQ-9 total score is interpreted as follows: 0-4 represents minimal depression, 5-9 as mild depression, 10-14 as moderate depression, 15-19 moderately severe depression, and 20-27 severe depression."|Baseline to Endpoint (90 days)|Analyses were performed on the 554 patients who had a baseline PHQ-9>=5 and further analyzed by baseline depression severity groups defined by baseline PHQ-9 scores: 5<=PHQ-9<=9; 10<=PHQ-9<=14; 15<=PHQ-9<=19; and 20<=PHQ-9<=27.||units on a scale||Standard Deviation|Mean
697243|NCT01368965|Other Pre-specified|Subject Assessment of Pain|Subject assessment of pain using a validated Numeric Rating Scale (NRS), 0-10, where 0 = no pain and 10=worse pain possible. Subjects' sensory responses to the treatment exposures were recorded using the NRS for each anatomical region.|During Ulthera treatment|||Average NRS score||Full Range|Mean
697244|NCT01368965|Secondary|Patient Satisfaction Questionnaire|Subjects indicated whether they saw improvement, i.e., providing a Yes/No response, in face and neck characteristics at six months (D180) post Ulthera treatment. Pre-treatment and Day 180 post-treatment photographs were available for viewing during the assessment. Subjects also had a mirror in hand for real time assessment. Subjects' Yes/No responses were tabulated.|180 days post-treatment|Data analyzed includes PSQ responses at 180 days post-treatment assessing subjects' satisfaction with study treatment. Responses were tabulated. Outcomes reported represent the percentage of subjects reporting any satisfaction, i.e., Very Satisfied and Satisfied.||percentage of participants Satisfied|||Number
697245|NCT01368965|Secondary|Patient Satisfaction Questionnaire|Subjects indicated whether they saw improvement, i.e., providing a Yes/No response, in face and neck characteristics at three months (D90) post Ulthera treatment. Pre-treatment and Day 90 post-treatment photographs were available for viewing during the assessment. Subjects also had a mirror in hand for real time assessment. Subjects' Yes/No responses were tabulated.|90 Days post-treatment|Data analyzed includes PSQ responses at 90 days post-treatment assessing subjects' satisfaction with study treatment. Responses were tabulated. Outcomes reported represent the percentage of subjects reporting any satisfaction, i.e., Very Satisfied and Satisfied.||percentage of participants Satisfied|||Number
697246|NCT01368965|Secondary|Global Aesthetic Improvement at 180 Days Post-treatment|At 180 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS), comparing with pre-treatment photos. PGAIS = Physician Global Aesthetic Improvement Scale; SGAIS = Subject Global Aesthetic Improvement Scale.|180 days post-treatment|"Subjects completing the 180-Day SGAIS = 39; however, the 180-Day PGAIS was not obtained for 2 subjects. PGAIS data are based on n=37.
The GAIS is 5-point scale (1-5) describing an overall assessment as follows:
= Very Much Improved
= Much Improved
= Improved
= No Change
= Worse"||percentage of participants improved|||Number
697247|NCT01368965|Secondary|Global Aesthetic Improvement at 90 Days Post-treatment|At 90 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS), comparing with pre-treatment photos. PGAIS = Physician Global Aesthetic Improvement Scale; SGAIS = Subject Global Aesthetic Improvement Scale.|90 Days post-treatment|"The GAIS is 5-point scale (1-5) describing an overall assessment as follows:
= Very Much Improved
= Much Improved
= Improved
= No Change
= Worse"||percentage of participants improved|||Number
697248|NCT01368965|Primary|Change in Overall Lifting and Tightening of Treated Tissue|The percentage of participants assessed to have improvement in skin laxity, i.e., lifted and tightened skin in the areas treated with the Ulthera System, as determined by three masked assessors comparing pre-treatment and 90-days post-treatment photos|90 days post treatment|Masked, qualitative assessment of standardized photographs at 90 days post treatment compared to baseline, could not be completed as images taken at one site were not recovered due to poor data management and staffing issues at the site.|||||
697249|NCT01368900|Other Pre-specified|Subject Assessment of Pain|Subjects' sensory responses to the treatment exposures were recorded for each anatomical region treated using a validated Numeric Rating Scale, 0-10, where 0 = no pain and 10 = worse pain possible.|Average pain scores reported during study treatment|The subjects' sensory responses to the treatment exposures were recorded for each anatomical region treated, using a validated numeric rating scale of 0-10 with 1 representing no pain and 10 representing the highest degree of pain.||units on a scale||Full Range|Mean
697250|NCT01368900|Secondary|Patient Satisfaction Questionnaire at 180 Days Post-treatment|Subject satisfaction determined by scores on a patient satisfaction questionnaire at 180 days post-treatment.|180 days post-treatment|Data analyzed included subjects completing a 180 day visit and a questionnaire assessing treatment satisfaction, comparing pre-treatment and day 180 post-treatment photographic images. Responses were tabulated. 60 of 61 subjects provided responses. One subject's response was missing.||percentage of participants Satisfied|||Number
697251|NCT01368900|Secondary|Patient Satisfaction Questionnaire 90 Days Post-treatment|Subject satisfaction determined by scores on a patient satisfaction questionnaire at 90 days post-treatment.|90 days post-treatment|Data analyzed included subjects completing a 90 day visit and a questionnaire assessing treatment satisfaction, comparing pre-treatment and day 90 post-treatment photographic images. Responses were tabulated.||percentage of participants Satisfied|||Number
697252|NCT01368900|Secondary|Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 180 Days Post-treatment|"At 180 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS), comparing with pre-treatment photos. The GAIS is 5-point scale (1-5) describing an overall assessment as follows:
= Very Much Improved
= Much Improved
= Improved
= No Change
= Worse
Any Improvement includes subjects assessed in categories 1-3."|180 days post-treatment|Data analysis was based on participants who completed a Subject Global Aesthetic Improvement scale (SGAIS) and were assessed by a study investigator via completion of a Physician Global Aesthetic Improvement scale (PGAIS)at 180 days post-treatment, per protocol.||percentage of participants improved|||Number
701114|NCT00059787|Primary|The Percentage of Participants Experiencing Toxicty (Grade 2 and Grade 3/4) Associated With the Combined Regimen|Adverse event assessment|For the duration of the study up to 7 years|Patients enrolled on all stratums included||percentage of participants|||Number
697253|NCT01368900|Secondary|Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 90 Days Post-treatment|"At 90 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS), comparing with pre-treatment photos. The GAIS is 5-point scale (1-5) describing an overall assessment as follows:
= Very Much Improved
= Much Improved
= Improved
= No Change
= Worse
Any Improvement includes subjects assessed in categories 1-3."|90 days post-treatment|Data analysis was based on participants who completed a Subject Global Aesthetic Improvement scale (SGAIS) and were assessed by a study investigator via completion of a Physician Global Aesthetic Improvement scale (PGAIS)at 90 days post-treatment, per protocol.||percentage of participants improved|||Number
697254|NCT01368900|Secondary|Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 60 Days Post-treatment|"At 60 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS), comparing with pre-treatment photos. The GAIS is 5-point scale (1-5) describing an overall assessment as follows:
= Very Much Improved
= Much Improved
= Improved
= No Change
= Worse
Any Improvement includes subjects assessed in categories 1-3."|60 days post-treatment|At 60 days, the PI and subject completed a GAIS (PGAIS and SGAIS, respectively)for comparison to pre-treatment.||percentage of participants improved|||Number
697255|NCT01368900|Primary|Overall Improvement in Periorbital Wrinkles and Rhytids Around the Eyes|Improvement in periorbital skin laxity and rhytids as determined by masked assessor review of photographs at 90days post-treatment compared to baseline.|90 days post-treatment|Primary endpoint: Three masked assessors reviewed pre- and 90 days post-treatment photos, assessing each eye separately. 41 right, 42 left eye photos were found to be usable. Photos excluded had photographic lighting, focus and exposure inconsistencies obscuring key physical details making pre- vs. post-treatment photo comparisons impossible.||percentage of participants improved|||Number
697256|NCT01368874|Secondary|L'Oreal Photographic Scale 180 Days Post-treatment|"At 180 days post-treatment, the Principal Investigator (PI) assessed the subjects' horizontal neck folds, neck sagging, and texture and ptosis changes using the L'Oreal Photographic Scales. The L'Oreal scales include the following categories, with a higher grade denoting an increased severity in each category:
Horizontal neck folds (Grades 0-6)
Neck sagging (Grades 0-7);
Texture (Female grades 0-5; male grades 0-7);
Ptosis (Female grades 0-5; males grades 0-7)."|180 Days post-treatment|||units on a scale||Full Range|Mean
697257|NCT01368874|Secondary|L'Oreal Photographic Scale 90 Days Post-treatment|"At 90 days post-treatment, the Principal Investigator (PI) assessed the subjects' horizontal neck folds, neck sagging, and texture and ptosis changes using the L'Oreal Photographic Scales. The L'Oreal scales include the following categories, with a higher grade denoting an increased severity in each category:
Horizontal neck folds (Grades 0-6)
Neck sagging (Grades 0-7);
Texture (Female grades 0-5; male grades 0-7);
Ptosis (Female grades 0-5; males grades 0-7)."|90 Days post-treatment|||units on a scale||Full Range|Mean
697258|NCT01368874|Secondary|L'Oreal Photographic Scale Baseline|"At baseline, the Principal Investigator (PI) assessed the subjects’ horizontal neck folds, neck sagging, and texture and ptosis changes using the L’Oreal Photographic Scales. The L’Oreal scales include the following categories, with a higher grade denoting an increased severity in each category:
Horizontal neck folds (Grades 0-6)
Neck sagging (Grades 0-7);
Texture (Female grades 0-5; male grades 0-7);
Ptosis (Female grades 0-5; males grades 0-7)."|Baseline|||units on a scale||Full Range|Mean
697259|NCT01368874|Secondary|Patient Satisfaction Questionnaire 180 Days Post-treatment|Patient satisfaction was determined by scores on a patient satisfaction questionnaire (PSQ) completed at 180 days post-treatment. Subjects indicated on a PSQ whether they saw improvement in the ares treated, i.e., providing a Yes/No response, and how satisfied they were with their Ulthera treatment, i.e., Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Pre-treatment and Day 180 post-treatment photographs were available for viewing during the assessment. Subjects also had a mirror in hand for real time assessment, comparing pre-treatment and 180 day post-treatment photos. Proportions of subjects reporting Improvement, and Very Satisfied and Satisfied are included.|180 days post-treatment|||Percentage of participants|||Number
697260|NCT01368874|Secondary|Patient Satisfaction 90 Days Post-treatment|Patient satisfaction was determined by scores on a patient satisfaction questionnaire (PSQ) completed at 90 days post-treatment. Subjects indicated on a PSQ whether they saw improvement in the areas treated, i.e., providing a Yes/No response, and how satisfied they were with their Ulthera treatment, i.e., Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Pre-treatment and Day 90 post-treatment photographs were available for viewing during the assessment. Subjects also had a mirror in hand for real time assessment, comparing pre-treatment and 90 day post-treatment photos. Proportions of subjects reporting Improvement, and Very Satisfied and Satisfied are included.|90 Days post-treatment|||Percentage of participants|||Number
697261|NCT01368874|Secondary|Improvement in Overall Lifting and Tightening of Jowl and/or Neck Laxity , as Assessed by the Principal Investigator (PI) and the Subject Using the Global Aesthetic Improvement Scale, i.e., PGAIS and SGAIS, Respectively.|"At 180 days post-treatment, a PGAIS and SGAIS were completed based on a live assessment of the subject and a photographic assessment comparing post-treatment photos to baseline photos, to assess overall aesthetic improvement. The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:
- Very Much Improved
- Much Improved
- Improved
- No Change
- Worse Any Improvement includes participants assessed in categories 1-3"|180 days post-treatment|At 180 days post-treatment, the PI and subject completed a Global Aesthetic Improvement Scale (PGAIS and SGAIS, respectively)for comparison to pre-treatment.||percentage of participants improved|||Number
697262|NCT01368874|Other Pre-specified|Subjects' Assessment of Pain|Subjects' sensory response to the Ulthera treatment exposures were recorded for each anatomical region treated using a validated Numeric Rating Scale (0-10), with 0 representing no pain and 10 representing the worst pain possible.|During Ulthera treatment|||units on a scale||Full Range|Mean
697263|NCT01368874|Primary|Improvement in Overall Lifting and Tightening of the Jowls and/or Neck Laxity - RE-ANALYZED GROUP|"Improvement in overall lifting and tightening of skin as determined by masked, qualitative assessment of photographs at 90 days post-treatment compared to baseline. Efficacy was based on the number of treated subjects assessed as improved in skin laxity, horizontal neck folds, neck sagging, texture and/or ptosis.
A data set of 42 of the 61 participants were re-analyzed. Data were removed for 19 participants whose pre-treatment and/or post-treatment photos were of poor photo quality, i.e., poor lighting, poor focus, poor positioning, creating the potential for biasing the masked assessment results."|90 Days post-treatment|||participants|||Number
697264|NCT01368874|Secondary|Improvement in Overall Lifting and Tightening of Jowl and/or Neck Laxity, as Assessed by the Principal Investigator (PI) and the Subject Using the Global Aesthetic Improvement Scale, i.e., PGAIS and SGAIS, Respectively.|"At 90 days post-treatment, a PGAIS and SGAIS were completed based on a live assessment of the subject and a photographic assessment comparing post-treatment photos to baseline photos, to assess overall aesthetic improvement. The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:
- Very Much Improved
- Much Improved
- Improved
- No Change
- Worse Any Improvement includes participants assessed in categories 1-3"|90 days post-treatment|At 90 days post-treatment, the PI and subject completed a Global Aesthetic Improvement Scale (PGAIS and SGAIS, respectively)for comparison to pre-treatment.||percentage of participants improved|||Number
697265|NCT01368874|Secondary|Improvement in Overall Lifting and Tightening of Jowl and/or Neck Laxity, as Assessed by the Principal Investigator (PI) and the Subject Using the Global Aesthetic Improvement Scale, i.e., PGAIS and SGAIS, Respectively.|"At 60 days post-treatment, a PGAIS and SGAIS were completed based on a live assessment of the subject and a photographic assessment comparing post-treatment photos to baseline photos, to assess overall aesthetic improvement. The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:
- Very Much Improved
- Much Improved
- Improved
- No Change
- Worse Any Improvement includes participants assessed in categories 1-3"|60 days post-treatment|At 60 days post-treatment, the PI and subject completed a Global Aesthetic Improvement Scale (PGAIS and SGAIS, respectively)for comparison to pre-treatment.||percentage of participants improved|||Number
697266|NCT01368874|Primary|Improvement in Overall Lifting and Tightening of the Jowls and/or Neck Laxity|Improvement in overall lifting and tightening of skin as determined by masked, qualitative assessment of photographs at 90 days post-treatment compared to baseline. Efficacy was based on the number of treated subjects assessed as improved in skin laxity, horizontal neck folds, neck sagging, texture and/or ptosis.|90 Days post-treatment|||participants|||Number
697267|NCT01368835|Other Pre-specified|Subject Assessment of Pain|Subject assessment of pain using a validated Numeric Rating Scale (NRS), 0-10, where 0 = no pain and 10=worse pain possible. Subjects' sensory responses to the treatment exposures were recorded using the NRS for each anatomical region.|During Ulthera study treatment|Evaluable subjects, i.e., n=70, who received an Ulthera treatment and for whom an NRS was completed.||Average NRS score||Full Range|Mean
697268|NCT01368835|Secondary|Patient Satisfaction Questionnaire|Subjects indicated whether they saw improvement, i.e., providing a Yes/No response, in face and neck characteristics at three months (D90) post Ulthera treatment. Pre-treatment and Day 90 post-treatment photographs were available for viewing during the assessment. Subjects also had a mirror in hand for real time assessment. Subjects' Yes/No responses were tabulated.|90D|The number of participants who received an Ulthera treatment and for whom pre-treatment and 90-day post-treatment photos were available.||percentage of participants improved|||Number
697269|NCT01368835|Secondary|Change in Submental and Neck Skin Laxity by Quantitative Analysis|The percentage of participants assessed as having an improvement in tissue lift, i.e., >20mm2 in submental and neck skin laxity, at 90 Days post-treatment compared to baseline based on quantitative analysis.|90D|The number of participants who received an Ulthera treatment and for whom pre-treatment and 90-day post-treatment photos were available, i.e., evaluable participants.||percentage of participants improved|||Number
697270|NCT01368835|Primary|Change in Overall Lifting and Tightening of Treated Tissue on the Lower Face and Submental Regions.|The percentage of participants assessed to have improvement in skin laxity, i.e., lifted and tightened skin in the areas treated with the Ulthera System, as determined by three masked assessors comparing pre-treatment and 90-days post-treatment photos from 70 subjects who returned for their 90-day follow-up visit.|90D|The number of participants who received an Ulthera treatment and for whom pre-treatment and 90-day post-treatment photos were available, i.e., evaluable participants, for a masked assessment.||percentage of participants improved|||Number
697271|NCT01368809|Secondary|Postoperative Pain|"Postoperative pain measured using a Verbal Rating Scale (VRS) at post-anesthesia care unit (PACU), (90 minutes after arriving).
Postoperative pain VRS scores: 0 = none pain to 10 = intolerable pain."|one day|||Scores on a scale||Standard Deviation|Mean
697272|NCT01368809|Secondary|Incidence of Nausea and Vomiting|Postoperative nausea and vomiting using a Verbal Rating Scale (0-10) at PACU (post-anesthesia care unit.|1 day|||participants|||Number
697273|NCT01368809|Primary|Incidence of Coughing|during the perioperative period (insertion of an LMA device, maintenance of anesthesia, and emergence from general anesthesia) for ambulatory surgery procedures.|one day|||participants|||Number
697274|NCT01368653|Secondary|Prolonged Abstinence|This outcome measures whether regular smoking (7 days in a row) occurred between the 4th and 10th weeks of the quit attempt.|10 weeks|||participants|||Number
697275|NCT01368653|Secondary|Mediators of Treatment Effects|Emotional, mental, and behavioral measures that may help explain treatment effects on tobacco use outcomes will be assessed intensively in the three weeks leading up to a quit attempt and the first week of a quit attempt to examine mediators of the first phase treatment. Additional analyses of reports of emotions, thoughts, and behaviors will explore mediators of non-nicotine cigarette effects on smoking. These measures will be analyzed to see if treatment affects them and if they predict smoking behavior.|1 week post-quit and 6 weeks post-quit||||||
697276|NCT01368653|Secondary|10-week Abstinence|This captures whether any tobacco use occurred in the past 7 days at the 10-week follow up (i.e., whether any tobacco use occurred in the 10th week of the quit attempt), as reported by participants in a timeline follow-back telephone interview and confirmed by a follow-up expired carbon monoxide reading less than or equal to 8 parts per million.|10 weeks|||participants|||Number
697277|NCT01368653|Primary|4-week Abstinence|7-day point prevalence abstinence captures whether participants have used tobacco in the past 7 days at the 4-week post-quit follow-up (i.e., whether any tobacco use occurred in the 4th week of the quit attempt).|4 weeks|||participants|||Number
697278|NCT01368536|Secondary|Number of Patients With Adverse Events, Serious Adverse Events and Death to Assess Safety and Tolerability of Treatment With Valturna and Chlorthalidone or Valturna and Amlodipine Versus Valturna Alone||12 weeks|Safety Set — Consists of all patients who received at least one dose of the double-blind study drug. Patients were analyzed according to the treatment that they received.||Participants|||Number
701115|NCT00059787|Primary|Pathologic Complete Response Rates|Pathologic complete response was defined as having no pathologic or cytologic evidence of disease following surgical reassessment.|Up to 7 years|Patients who had optimally debulking surgery||participants|||Number
697281|NCT01368536|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) After 12 Weeks of Treatment|Sitting blood pressure (BP) was measured at trough (24 hours ± 3 hours postdose) and recorded at all study visits. At the first study visit, the patient had his/her BP measured in both arms; the arm in which the highest sitting DBP was found was used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for 5 minutes, DBP were measured 3 times using a standard mercury sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1- to 2-minute intervals and the mean of those 3 measurements was used as the average sitting office BP for that visit.|Baseline, 12 weeks|The study was terminated and consequentially was underpowered for adequate statistical analysis|||||
697282|NCT01368536|Secondary|Change From Baseline in MSSBP After 12 Weeks of Treatment Ending With Between the Valturna + Chlorthalidone Combination and Valturna Alone|Sitting BP was measured at trough (24 hours ± 3 hours postdose) and recorded at all study visits. At the first study visit, the patient had his/her BP measured in both arms; the arm in which the highest sitting DBP was found was used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for 5 minutes, SBP were measured 3 times using a standard mercury sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1- to 2-minute intervals and the mean of those 3 measurements was used as the average sitting office BP for that visit.|Baseline, 12 weeks|The study was terminated and consequentially was underpowered for adequate statistical analysis|||||
697283|NCT01368536|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) After 12 Weeks of Treatment Ending With the Combination of Valturna and Amlodipine Versus Valturna Alone|Sitting BP was measured at trough (24 hours ± 3 hours postdose) and recorded at all study visits. At the first study visit, the patient had his/her BP measured in both arms; the arm in which the highest sitting DBP was found was used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for 5 minutes, SBP were measured 3 times using a standard mercury sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1- to 2-minute intervals and the mean of those 3 measurements was used as the average sitting office BP for that visit.|Baseline, 12 weeks|The study was terminated and consequentially was underpowered for adequate statistical analysis|||||
697284|NCT01368432|Secondary|Mini Mental Status Exam (MMSE)|"This outcome measure assess the participants Cognitive status. Scores range from 0 ( significantly impaired) -30 ( normal).
A score of 23 or lower is indicative of cognitive impairment. In this study the score was used as a continuous variable."|At 12 weeks|||units on a scale||Standard Deviation|Mean
697285|NCT01368432|Secondary|Mini Mental Status Exam (MMSE)|"This outcome measure assess the participants Cognitive status. Scores range from 0 ( significantly impaired) -30 ( normal).
A score of 23 or lower is indicative of cognitive impairment. In this study the score was used as a continuous variable."|At baseline|||units on a scale||Standard Deviation|Mean
697286|NCT01368432|Secondary|Disability Rating Scale (DRS)|"This scale is a measure of impairment, disability and handicap. It is intended to measure accurately general functional changes over the course of recovery and has found to be both valid and reliable.
Scores range from 0 (normal) and 29 (extreme vegetative state)."|At 12 weeks|||units on a scale||Standard Deviation|Mean
697287|NCT01368432|Secondary|Disability Rating Scale (DRS)|"This scale is a measure of impairment, disability and handicap. It is intended to measure accurately general functional changes over the course of recovery and has found to be both valid and reliable.
Scores range from 0 (normal) and 29 (extreme vegetative state)."|At baseline|||units on a scale||Standard Deviation|Mean
697288|NCT01368432|Secondary|Quality of Life (QWL)|"This outcome measure is assessing the participants impression of their quality of life as measured by the QWL scale.
Scores range from 16 ( terrible quality of life ) to 112 (Very delighted). Used as a continuous variable."|At 12 weeks|||units on a scale||Standard Deviation|Mean
697289|NCT01368432|Secondary|Quality of Life (QWL)|"This outcome measure is assessing the participants impression of their quality of life as measured by the QWL scale.
Scores range from 16 ( terrible quality of life ) to 112 (Very delighted). Used as a continuous variable."|At baseline|||units on a scale||Standard Deviation|Mean
697290|NCT01368432|Secondary|Satisfaction With Life (SWL)|"This outcome measure asses the participants overall satisfaction with life as measured by the SWL scale.
The scores range from 5 ( absolutely no satisfaction ) to 35 ( very satisfied with life).
It is used as continuous variable."|12 weeks|||units on a scale||Standard Deviation|Mean
697291|NCT01368432|Secondary|Satisfaction With Life (SWL)|"This outcome measure asses the participants overall satisfaction with life as measured by the SWL scale.
The scores range from 5 ( absolutely no satisfaction ) to 35 ( very satisfied with life).
It is used as continuous variable."|baseline|||units on a scale||Standard Deviation|Mean
697292|NCT01368432|Secondary|Clinical Anxiety Scale (CAS)|"This outcome measure is assessing the participant's anxiety as assessed by the CAS.
The scores range from 0( normal; no anxiety) to 21 ( severe anxiety). It is used as a continuous variable."|12 weeks|||units on a scale||Standard Deviation|Mean
697293|NCT01368432|Secondary|Clinical Anxiety Scale (CAS)|"This outcome measure is assessing the participant's anxiety as assessed by the CAS.
The scores range from 0( normal; no anxiety) to 21 ( severe anxiety). It is used as a continuous variable."|Baseline|||units on a scale||Standard Deviation|Mean
697294|NCT01368432|Secondary|Clinical Global Impression (CGI)- Improvement|"This outcome measure is assessing the participant's overall psychiatric health based upon the CGI score as assessed by the investigator.
The scores range from 1-7
= Very much improved
= Much improved
= Minimally improved
= No change
= Minimally worse
= Much worse
= Very much worse"|at 12 weeks|||units on a scale||Standard Deviation|Mean
697295|NCT01368432|Secondary|Clinical Global Impression (CGI) - Severity at Baseline|"This outcome measure is assessing the participant's overall psychiatric health based upon the CGI score as assessed by the investigator. Scores range from 1-7
= Normal—not at all ill
= Borderline mentally ill
= Mildly ill
= Moderately ill
= Markedly ill
= Severely ill
= Among the most extremely ill patients."|Baseline|||units on a scale||Standard Deviation|Mean
697296|NCT01368432|Primary|Montgomery-Asberg Depression Rating Scale (MADRS)|"This scale assesses the range of symptoms most frequently observed in patients with major depression. This measure will be used to assess the difference in Montgomery-Asberg Depression Rating Scale (MADRS) at baseline and 12 weeks. The scores range from 0-60.
0 to 6 – normal; 7 to 19 – mild depression; 20 to 34 – moderate depression; >34 – severe depression.
In this study the score was used as a continuous variable."|MADRS score at 12 weeks|||units on a scale||Standard Deviation|Mean
697297|NCT01368432|Primary|Montgomery-Asberg Depression Rating Scale (MADRS) at Baseline|"This scale assesses the range of symptoms most frequently observed in patients with major depression. This measure will be used to assess the difference in Montgomery-Asberg Depression Rating Scale (MADRS) at baseline and 12 weeks. The scores range from 0-60.
0 to 6 – normal; 7 to 19 – mild depression; 20 to 34 – moderate depression; >34 – severe depression.
In this study the score was used as a continuous variable."|MADRS score at baseline|||units on a scale||Standard Deviation|Mean
697298|NCT01368406|Primary|Change in Weight From Baseline to Endpoint|All patients were weighed in the morning, on the same scale, without shoes, with the individuals wearing light clothes.Measures were collected by the same investigator in all assessments.|baseline, 3-month|||kg||95% Confidence Interval|Mean
697299|NCT01368276|Secondary|Durable Response Rate|"Durable response rate is defined as the percentage of participants with a complete response (CR) or partial response (PR) assessed by the investigator, initiating at any time while receiving talimogene laherparepvec or GM-CSF therapy on the 005/05 or the 005/05-E study and maintained continuously for at least 6 months from response initiation. This reflects all new sites of disease as well as disease sites identified at baseline.
Disease assessments were performed at the beginning of each treatment cycle in accordance with modified World Health Organization criteria.
CR: Disappearance of all clinical evidence of tumor (both measurable and non-measurable but evaluable disease); PR: ≥ 50% reduction in the sum of the products of the perpendicular diameters of all measurable tumors at the time of assessment as compared to baseline."|From randomization in study 005/05 until the data-cut-off date for the extension period of 08 August 2014; median treatment duration for 005/05 and 005/05-E studies combined was 88 weeks for talimogene laherparepvec and 100 weeks for GM-CSF.|Full analysis set||percentage of participants||95% Confidence Interval|Number
697300|NCT01368276|Secondary|Objective Response Rate|"Objective response rate was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) assessed by the investigator. Best overall response for a patient is the best overall response observed across all time points and is cumulative (ie, includes responses during the parent study 005/05 and during Study 005/05-E).
Disease assessments were performed at the beginning of each treatment cycle and assessed in accordance with modified World Health Organization criteria.
CR: Disappearance of all clinical evidence of tumor (both measurable and non-measurable but evaluable disease); PR: ≥ 50% reduction in the sum of the products of the perpendicular diameters of all measurable tumors at the time of assessment as compared to baseline."|From randomization in study 005/05 until the data-cut-off date for the extension period of 08 August 2014; median treatment duration for 005/05 and 005/05-E studies combined was 88 weeks for talimogene laherparepvec and 100 weeks for GM-CSF.|The full analysis set for the extension study is defined as all participants who received at least one dose of extension treatment.||percentage of participants||95% Confidence Interval|Number
697301|NCT01368276|Primary|Number of Participants With Treatment-emergent Adverse Events (AEs)|"AEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 based on the following guideline:
Grade 1: Mild AE; Grade 2: Moderate AE; Grade 3: Severe AE; Grade 4: Life-threatening or disabling AE; Grade 5: Death related to AE.
Treatment-related AE refers to AEs that have possible or probable relation to study treatment as determined by the investigator.
A serious AE is one that meets one or more of the following criteria/outcomes:
Results in death.
Is life-threatening.
Requires inpatient hospitalization or prolongation of existing hospitalization.
Results in persistent or significant disability/incapacity.
Is a congenital anomaly/birth defect.
Is an important medical event."|From first administration of study drug in the extension period until 30 days after last dose. Median duration of treatment was 50 weeks in the GM-CSF group and 36 weeks in the talimogene laherparepvec group.|Safety population (randomized participants who received at least one dose of extension treatment).||participants|||Number
697302|NCT01368263|Secondary|PEPI-0 Rate in Patients Whose Estradiol is Fully Suppressed (< or = 15 pg/mL) and Tumor Ki67 Level is 10% or Less||16 weeks|(1) of the participants in Group 1 had an inconclusive PEPI score at week 16 and was not evaluable. (1) of the participants in Group 1 did not have surgery and was not evaluable. Participants in Group 2 and Group 3 were not evaluable for this outcome as the estradiol and Ki67 levels were above outcome specified levels.||percentage of participants|||Number
697303|NCT01368263|Secondary|Preoperative Endocrine Prognostic Index Score (PEPI Score)|To obtain the PEPI score, risk points for relapse-free survival (RFS) and breast cancer-specific survival (BCSS) are assigned depending on the hazard ratio (HR) from the multivariable analysis. The total PEPI score assigned to each patient is the sum of the risk points derived from the pT stage, pN stage, Ki67 level, and estrogen receptor status of the surgical specimen. A HR in the range of 1 to 2 receives one risk point; a HR in the 2 to 2.5 range, two risk points; a HR greater than 2.5, three risk points. The total risk point score for each patient is the sum of all the risk points accumulated from the four factors in the model, ranges from 0 (best possible outcome) to 12 (worst possible outcome).|At time of definitive surgery|2 participants in Group 1 did not have a PEPI score at time of surgery as (1) participant did not have nodal dissection and (1) did not have surgery. Both participants in Group 2 and Group 3 did not have surgery study tissue collected||participants|||Number
697304|NCT01368263|Secondary|Relationship Between Pretreatment FFNP-PET Standard Uptake Value (SUV) and 4-week Post-treatment Ki-67||Baseline and 4 weeks post-treatment|This outcome was not analyzed due to funding issues.|||||
697305|NCT01368263|Primary|Acceptability of Management With Surgical Oophorectomy/Continued LHRH With Continued Oral Endocrine Therapy and no Chemotherapy|Proportion of patients with a PEPI score of 0 and pathological stage 1 who choose to forego chemotherapy.|6 months post neoadjuvant endocrine therapy and surgery|None of the participants had a PEPI score and 0 and pathological stage 1.|||||
697306|NCT01368263|Primary|Pathologic Complete Response (CR) Rate|"In patients with Ki67 >10% and <= 15 pg/ml at 4 weeks.
The pCR rate for neo-adjuvant chemotherapy is defined as 100 times the number of eligible patients with no histologic evidence of invasive tumor cells in the surgical breast specimen and the axillary or sentinel lymph nodes divided by the total number of eligible patients who received neo-adjuvant chemotherapy."|1 month|There were no evaluable participants to analyze in Group 1, 2, or 3. No participants met the criteria for Ki67 >10% and estradiol levels of <= 15 pg/ml at 4 weeks.|||||
697307|NCT01368211|Secondary|Change in Maximum Amplitude at 24-hours Post-transfusion|Thromboelastography parameter: Pre- to post-transfusional modification in Maximum Amplitude at 24-hours post-transfusion|pre-transfusion, 24-hour post transfusion|||mm||Standard Deviation|Mean
697316|NCT01368042|Secondary|Change Per Month From Baseline to 6 Months in Parathyroid Hormone (PTH) Levels (pg/mL Per Month)|PTH levels were recorded at each study visit prior to hemodialysis according to routine clinical practice and at the discretion of the physician. Linear models based on Generalized Estimating Equations (GEE) were used to assess the effect of time on change from enrollment (at least 1 month after starting treatment with paricalcitol iv) through 3 months post-enrollment and 6 months post-enrollment.|Enrollment, 3 months post-enrollment, 6 months post-enrollment|All participants in the enrolled population with available data at the study timepoints, regardless of whether or not they completed the study (i.e., the 6-month post-enrollment follow-up). Of the 265 participants enrolled, 11 were considered to have protocol deviations and excluded; therefore, 254 participants were included in the study analyses.||pg/mL per month||95% Confidence Interval|Mean
697317|NCT01368042|Secondary|Change From Enrollment to 6 Months in Parathyroid Hormone (PTH) Levels (pg/mL)|PTH levels were recorded at each study visit prior to hemodialysis according to routine clinical practice and at the discretion of the physician. The change from enrollment (at least 1 month after starting treatment with paricalcitol iv) to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit value minus the enrollment value.|Enrollment, 6 months|All enrolled participants with available data at the study timepoints, regardless of whether or not they completed the study (i.e., the 6-month post-enrollment follow-up).||pg/mL||Standard Deviation|Mean
697318|NCT01368042|Secondary|Change From Enrollment to 6 Months Post-enrollment in Calcium-Phosphorous (Ca×P) Product Levels (mg˄2/dL˄2)|Ca×P product levels were recorded at each study visit prior to hemodialysis according to routine clinical practice and at the discretion of the physician. The change from enrollment (at least 1 month after starting treatment with paricalcitol iv) to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit value minus the enrollment value.|Enrollment, 6 months post-enrollment|All participants in the enrolled population with available data at the study timepoints, regardless of whether or not they completed the study (i.e., the 6-month post-enrollment follow-up). Of the 265 participants enrolled, 11 were considered to have protocol deviations and excluded; therefore, 254 participants were included in the study analyses.||mg˄2/dL˄2||Standard Deviation|Mean
697319|NCT01368042|Secondary|Change From Enrollment to 6 Months Post-enrollment in Phosphorous Levels (mg/dL)|Phosphorous levels were recorded at each study visit prior to hemodialysis according to routine clinical practice and at the discretion of the physician. The change from enrollment (at least 1 month after starting treatment with paricalcitol iv) to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit value minus the enrollment value.|Enrollment, 6 months post-enrollment|All participants in the enrolled population with available data at the study timepoints, regardless of whether or not they completed the study (i.e., the 6-month post-enrollment follow-up). Of the 265 participants enrolled, 11 were considered to have protocol deviations and excluded; therefore, 254 participants were included in the study analyses.||mg/dL||Standard Deviation|Mean
697320|NCT01368042|Secondary|Change From Enrollment to 6 Months Post-enrollment in Calcium Levels (mg/dL)|Calcium levels were recorded at each study visit prior to hemodialysis according to routine clinical practice and at the discretion of the physician. The change from enrollment (at least 1 month after starting treatment with paricalcitol iv) to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit value minus the enrollment value.|Enrollment, 6 months post-enrollment|All participants in the enrolled population with available data at the study timepoints, regardless of whether or not they completed the study (i.e., the 6-month post-enrollment follow-up). Of the 265 participants enrolled, 11 were considered to have protocol deviations and excluded; therefore, 254 participants were included in the study analyses.||mg/dL||Standard Deviation|Mean
697321|NCT01368042|Secondary|Change From Enrollment to 6 Months Post-enrollment in Creatinine Levels (mg/dL)|Creatinine levels were recorded at each study visit prior to hemodialysis according to routine clinical practice and at the discretion of the physician. The change from enrollment (at least 1 month after starting treatment with paricalcitol iv) to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit value minus the enrollment value.|Enrollment, 6 months post-enrollment|All participants in the enrolled population with available data at the study timepoints, regardless of whether or not they completed the study (i.e., the 6-month post-enrollment follow-up). Of the 265 participants enrolled, 11 were considered to have protocol deviations and excluded; therefore, 254 participants were included in the study analyses.||mg/dL||Standard Deviation|Mean
697322|NCT01368042|Secondary|Change From Enrollment to 6 Months Post-enrollment in Urea Levels (mg/dL)|Urea levels were recorded at each study visit prior to hemodialysis according to routine clinical practice and at the discretion of the physician. The change from enrollment (at least 1 month after starting treatment with paricalcitol iv) to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit value minus the enrollment value.|Enrollment, 6 months post-enrollment|All participants in the enrolled population with available data at the study timepoints, regardless of whether or not they completed the study (i.e., the 6-month post-enrollment follow-up). Of the 265 participants enrolled, 11 were considered to have protocol deviations and excluded; therefore, 254 participants were included in the study analyses.||mg/dL||Standard Deviation|Mean
697323|NCT01368042|Primary|Change Per Month From Baseline to 6 Months Post-enrollment on the 8 Scales of the RAND 36-Item Health Survey|The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales (physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, bodily pain, general health perception, health change). Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the enrollment and post-enrollment visits was calculated as the visit score minus the baseline score. Linear models based on Generalized Estimating Equations (GEE) were used to assess the effect of time on change from baseline through enrollment, 3 months post-enrollment, and 6 months post-enrollment.|Baseline, enrollment, 3 months post-enrollment, 6 months post-enrollment|All participants in the enrolled population with an available RAND 36-Item Health Survey score at the study timepoints. Of the 265 participants enrolled, 11 were considered to have protocol deviations and were excluded from the enrolled population; therefore, 254 participants were included in the study analyses.||scores on a scale/month||95% Confidence Interval|Mean
715369|NCT00252187|Secondary|Change in Heart Rate at 8 Weeks|Heart rate was measured when MRI was performed|Baseline and 8 weeks|Per protocol population||beats per minute||Standard Deviation|Mean
697324|NCT01368042|Primary|Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Health Change' Item Scores|The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes a single question pertaining to the participant's health change over the last year. The scores range from 0 to 100, with 100: much better than 1 year ago; 75: somewhat better than 1 year ago; 50: about the same; 25: somewhat worse than 1 year ago; 0: much worse than 1 year ago. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.|Baseline, 6 months post-enrollment|All participants in the enrolled population with an available RAND 36-Item Health Survey score at the study timepoints. Of the 265 participants enrolled, 11 were considered to have protocol deviations and were excluded from the enrolled population; therefore, 254 participants were included in the study analyses.||scores on a scale||Standard Deviation|Mean
697325|NCT01368042|Primary|Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey ‘General Health Perceptions’ Scale Scores|The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales, including general health perceptions. The scores for each scale range from 0 to 100, with 0 representing the worst possible score and 100 representing the best possible score. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.|Baseline, 6 months post-enrollment|All participants in the enrolled population with an available RAND 36-Item Health Survey score at the study timepoints. Of the 265 participants enrolled, 11 were considered to have protocol deviations and were excluded from the enrolled population; therefore, 254 participants were included in the study analyses.||scores on a scale||Standard Deviation|Mean
697326|NCT01368042|Primary|Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey ‘Bodily Pain’ Scale Scores|The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales, including bodily pain. The scores for each scale range from 0 to 100, with 0 representing the worst possible score and 100 representing the best possible score. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.|Baseline, 6 months post-enrollment|All participants in the enrolled population with an available RAND 36-Item Health Survey score at the study timepoints. Of the 265 participants enrolled, 11 were considered to have protocol deviations and were excluded from the enrolled population; therefore, 254 participants were included in the study analyses.||scores on a scale||Standard Deviation|Mean
697327|NCT01368042|Primary|Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey ‘Social Functioning’ Scale Scores|The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales, including social functioning. The scores for each scale range from 0 to 100, with 0 representing the worst possible score and 100 representing the best possible score. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.|Baseline, 6 months post-enrollment|All participants in the enrolled population with an available RAND 36-Item Health Survey score at the study timepoints. Of the 265 participants enrolled, 11 were considered to have protocol deviations and were excluded from the enrolled population; therefore, 254 participants were included in the study analyses.||scores on a scale||Standard Deviation|Mean
697328|NCT01368042|Primary|Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey ‘Emotional Well-Being’ Scale Scores|The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales, including emotional well-being. The scores for each scale range from 0 to 100, with 0 representing the worst possible score and 100 representing the best possible score. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.|Baseline, 6 months post-enrollment|All participants in the enrolled population with an available RAND 36-Item Health Survey score at the study timepoints. Of the 265 participants enrolled, 11 were considered to have protocol deviations and were excluded from the enrolled population; therefore, 254 participants were included in the study analyses.||scores on a scale||Standard Deviation|Mean
697329|NCT01368042|Primary|Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey ‘Energy/Fatigue’ Scale Scores|The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales, including energy/fatigue. The scores for each scale range from 0 to 100, with 0 representing the worst possible score and 100 representing the best possible score. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.|Baseline, 6 months post-enrollment|All participants in the enrolled population with an available RAND 36-Item Health Survey score at the study timepoints. Of the 265 participants enrolled, 11 were considered to have protocol deviations and were excluded from the enrolled population; therefore, 254 participants were included in the study analyses.||scores on a scale||Standard Deviation|Mean
697342|NCT01367860|Secondary|Oswestry Disability Index (ODI) - 12th Month|"Oswestry Disability Index (ODI) -> The Oswestry Disability Index (ODI) is one of the principal condition-specific outcome measures used in the management of spinal disorders. The ODI is the most commonly outcome measures in patients with low back pain.
Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. If the FIRST statement is marked, the section score = 0, If the LAST statement is marked, it = 5.
0 is the best outcome and 50 is the worst outcome."|12th month from surgery|||units on a scale||Standard Deviation|Mean
701579|NCT00054717|Secondary|Virologic Response (VL < 400 Copies/ml) at Week 72|Percentage of participants with Viral Load < 400 copies/mL|Week 72|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
697330|NCT01368042|Primary|Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Role Limitations Due to Emotional Problems' Scale Scores|The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales, including role limitations due to emotional problems. The scores for each scale range from 0 to 100, with 0 representing the worst possible score and 100 representing the best possible score. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.|Baseline, 6 months post-enrollment|All participants in the enrolled population with an available RAND 36-Item Health Survey score at the study timepoints. Of the 265 participants enrolled, 11 were considered to have protocol deviations and were excluded from the enrolled population; therefore, 254 participants were included in the study analyses.||scores on a scale||Standard Deviation|Mean
697331|NCT01368042|Primary|Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Role Limitations Due to Physical Health' Scale Scores|The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales, including role limitations due to physical health. The scores for each scale range from 0 to 100, with 0 representing the worst possible score and 100 representing the best possible score. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.|Baseline, 6 months post-enrollment|All participants in the enrolled population with an available RAND 36-Item Health Survey score at the study timepoints. Of the 265 participants enrolled, 11 were considered to have protocol deviations and were excluded from the enrolled population; therefore, 254 participants were included in the study analyses.||scores on a scale||Standard Deviation|Mean
697332|NCT01368042|Primary|Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Physical Functioning' Scale Scores|The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales, including physical functioning. The scores for each scale range from 0 to 100, with 0 representing the worst possible state of physical functioning and 100 representing the best possible state of physical functioning. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.|Baseline, 6 months post-enrollment|All participants in the enrolled population with an available RAND 36-Item Health Survey score at the study timepoints. Of the 265 participants enrolled, 11 were considered to have protocol deviations and were excluded from the enrolled population; therefore, 254 participants were included in the study analyses.||scores on a scale||Standard Deviation|Mean
697333|NCT01367886|Secondary|Overactive Bladder Questionnaire (OAB-q) Will be Used to Assess Bother From Urinary Urgency at Baseline and at 6 Weeks..|Overactive bladder subjects answered the Overactive Bladder questionnaire (OAB-q) before starting Fesoterodine and at the end of taking 6 weeks of Fesoterodine. The OAB-q consists of 8 questions asking how bothered subject was in the past 4 weeks. Questions #2 (An uncomfortable urge to urinate?); #3 (A sudden urge to urinate with little or no warning?); #4 (Accidental loss of small amounts of urine?); #7 (An uncontrollable urge to urinate?); #8 (Urine loss associated with a strong desire to urinate?) are asking about urgency. Choices for answers are: 1 (Not at all); 2 (A little bit); 3 (Somewhat); 4 (Quite a bit); 5 (A great deal); 6 (A very great deal). Multiple responses to the questionnaire was averaged per participant at baseline and at 6 weeks and then all participants answers were totaled and then averaged at baseline and at 6 weeks.|Outcome measures were assessed at baseline and after the 6 week visit.|||scores on a scale||Standard Deviation|Mean
697334|NCT01367886|Primary|Bladder Diary (Using Urinary Sensation Scale Found in Bladder Diary) to Assess Urinary Urgency at Baseline and at 6-week Treatment|The Urinary Sensation Scale found in the bladder diary given to subjects was used to assess urinary urgency. The Urinary Sensation Scale was filled out by the subject for 3 days before starting Fesoterodine and filled out again for 3 days at the end of taking 6 weeks of Fesoterodine. The scale ranges from 1 (no feeling of urgency), 2 (mild), 3 (moderate), 4 (severe) to 5 (unable to hold; leak urine). The urgency scale with the most check marks per day over a period of 3 days before start of medication was averaged for each subject. The urgency scale with the most check marks per day over a period of 3 days at the end of taking 6 weeks of medication was averaged for each subject. Then, the average before start of medication for all subjects and the average at the end of taking 6 weeks of medication for all subjects were compared.|Outcome measure was assesses at baseline and at the end of the 6-week treatment period.|||scores on Urinary Sensation Scale||Standard Deviation|Mean
697335|NCT01367886|Secondary|Overactive Bladder Questionnaire (OAB-q) to Assess Bother From Urinary Frequency at Baseline and at 6 Weeks.|Overactive Bladder subjects answered the Overactive Bladder Questionnaire (OAB-q) before starting Fesoterodine and at the end of taking 6 weeks of Fesoterodine. The OAB-q consists of 8 questions asking how bothered subject was in the past 4 weeks. Questions # 1 (Frequent urination during the daytime hours?); #5 (Nighttime urination?) and #6 (Waking up at night because you have to urinate?) are asking about frequency. Choices of answers are: 1 (Not at all); 2 (A little bit); 3 (Somewhat); 4 (Quite a bit); 5 (A great deal) 6 (A very great deal). Multiple responses to the questionnaire were averaged for each participant at baseline and at 6 weeks and then all participants' answers were totaled and averaged at baseline and at 6 weeks.|Outcome measure was assessed at baseline and after the 6 week visit.|||scores on a scale||Standard Deviation|Mean
697336|NCT01367886|Primary|Bladder Diary to Assess Urinary Frequency at Baseline and at End of 6-week Treatment|Overactive bladder subjects filled out a 3-day bladder diary before starting Fesoterodine and another 3-day bladder diary at the end of taking 6 weeks of Fesoterodine. The bladder diary was used to assess urinary frequency. The average number of urinations (frequency) per day over a period of 3 days before the start of medication and at the end of 6 weeks of medication were compared for each subject and then as a group.|Outcome measure was assessed at baseline and at the end of the 6-week treatment|||urinations/day||Standard Deviation|Mean
697337|NCT01367860|Secondary|VAS for Leg Pain - 12th Month|pain scale - VAS for leg pain - 12th month|12th month from surgery|||units on a scale||Standard Deviation|Mean
715370|NCT00252187|Primary|Change in Left Ventricular (LV) Mass Index at 8 Weeks||Baseline and 8 weeks|Per protocol population||mg/m^2||Standard Deviation|Mean
697343|NCT01367860|Secondary|Oswestry Disability Index (ODI) - 6th Month|"Oswestry Disability Index (ODI) -> The Oswestry Disability Index (ODI) is one of the principal condition-specific outcome measures used in the management of spinal disorders. The ODI is the most commonly outcome measures in patients with low back pain.
Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. If the FIRST statement is marked, the section score = 0, If the LAST statement is marked, it = 5.
0 is the best outcome and 50 is the worst outcome."|6th month from surgery|Intention to treat||units on a scale||Standard Deviation|Mean
697344|NCT01367860|Primary|Oswestry Disability Index (ODI) - 3th Month|"Oswestry Disability Index (ODI) -> The Oswestry Disability Index (ODI) is one of the principal condition-specific outcome measures used in the management of spinal disorders. The ODI is the most commonly outcome measures in patients with low back pain.
Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. If the FIRST statement is marked, the section score = 0, If the LAST statement is marked, it = 5.
0 is the best outcome and 50 is the worst outcome."|3th month|Intention to treat||units on a scale||Standard Deviation|Mean
697345|NCT01367860|Secondary|Oswestry Disability Index (ODI) - 1st Month|"Oswestry Disability Index (ODI) -> The Oswestry Disability Index (ODI) is one of the principal condition-specific outcome measures used in the management of spinal disorders. The ODI is the most commonly outcome measures in patients with low back pain.
Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. If the FIRST statement is marked, the section score = 0, If the LAST statement is marked, it = 5.
0 is the best outcome and 50 is the worst outcome."|1st month from baseline|||units on a scale||Standard Deviation|Mean
697346|NCT01367860|Secondary|Oswestry Disability Index (ODI) - 1st Week|"Oswestry Disability Index (ODI) -> The Oswestry Disability Index (ODI) is one of the principal condition-specific outcome measures used in the management of spinal disorders. The ODI is the most commonly outcome measures in patients with low back pain.
Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. If the FIRST statement is marked, the section score = 0, If the LAST statement is marked, it = 5.
0 is the best outcome and 50 is the worst outcome."|1st week minus baseline|Intention to treat||units on a scale||Standard Deviation|Mean
697347|NCT01367860|Secondary|VAS for Lumbar Pain - 12th Month|Pain Score - Visual Analog Scale (VAS) -> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome.|12th month from surgery|||units on a scale||Standard Deviation|Mean
697348|NCT01367860|Secondary|VAS for Lumbar Pain - 6th Month|Pain Score - Visual Analog Scale (VAS) -> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome.|6th month from surgery|||units on a scale||Standard Deviation|Mean
697349|NCT01367860|Secondary|VAS for Lumbar Pain - 3rd Month|Pain Score - Visual Analog Scale (VAS) -> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome.|3rd month from surgery|||units on a scale||Standard Deviation|Mean
697350|NCT01367860|Secondary|VAS for Lumbar 1st Month|Pain Score - Visual Analog Scale (VAS) -> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome.|1st month from surgery|intention to treat||units on a scale||Standard Error|Mean
697351|NCT01367860|Secondary|VAS for Lumbar - 1st Week|Pain Score - Visual Analog Scale (VAS) -> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome.|1st week from surgery|||units on a scale||Standard Deviation|Mean
697352|NCT01367860|Secondary|Clinical Evaluation|"Will be measured dichotomously: (present or absent)
Variables:
Infection; residual pain; herniation recurrency"|6th month|Infection||participants|||Number
697353|NCT01367860|Primary|VAS for Lumbar Pain in 3 Months|Pain Score - Visual Analog Scale (VAS) -> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome.|VAS for Lumbar Pain at 3 Months|intention to treat||units on a scale||Standard Deviation|Mean
697354|NCT01367834|Secondary|Volume of Brain Lobes (Insular Cortex)|Percent change in volumes of parietal lobes as determined by MRI.|Change in volume from 12 months of age scan in 24 months of age scan|Note that only subjects with usable MRI data are included in this analysis (this is a subset of all children completing the protocol).||percentage change||Standard Deviation|Mean
697355|NCT01367834|Secondary|Volume of Brain Lobes (Limbic)|Percent change in volumes of parietal lobes as determined by MRI.|Change in volume from 12 months of age scan in 24 months of age scan|Note that only subjects with usable MRI data are included in this analysis (this is a subset of all children completing the protocol).||percentage change||Standard Deviation|Mean
697356|NCT01367834|Secondary|Volume of Brain Lobes (Parietal)|Percent change in volumes of parietal lobes as determined by MRI.|Change in volume from 12 months of age scan in 24 months of age scan|Note that only subjects with usable MRI data are included in this analysis (this is a subset of all children completing the protocol).||percentage change||Standard Deviation|Mean
697357|NCT01367834|Secondary|Volume of Brain Lobes (Temporal)|Percent change in volumes of temporal lobes as determined by MRI.|Change in volume from 12 months of age scan in 24 months of age scan|Note that only subjects with usable MRI data are included in this analysis (this is a subset of all children completing the protocol).||percentage change||Standard Deviation|Mean
697358|NCT01367834|Secondary|Volume of Brain Lobes (Frontal)|Percent change in volumes of frontal lobes as determined by MRI.|Change in volume from 12 months of age scan in 24 months of age scan|Note that only subjects with usable MRI data are included in this analysis (this is a subset of all children completing the protocol).||percentage change||Standard Deviation|Mean
697359|NCT01367834|Secondary|Volume of Brain Lobes (Central)|Percent change in volumes of central brain region (precentral gyrus, postcentral gyrus, rolandic operculum) as determined by MRI.|Change in volume from 12 months of age scan in 24 months of age scan|Note that only subjects with usable MRI data are included in this analysis (this is a subset of all children completing the protocol).||percentage change||Standard Deviation|Mean
697360|NCT01367834|Secondary|White Matter Tracts (SLF)|Change in the fractional anisotropy (FA) of white matter tracts using Diffusion Tensor Imaging (DTI); superior longitudinal fasciculus|Change in FA from 12 months of age scan in 24 months of age scan|Note that only subjects with usable MRI data are included in this analysis (this is a subset of all children completing the protocol).||percentage change||Standard Deviation|Mean
697361|NCT01367834|Secondary|Volume of Brain Lobes (Occipital)|Percent change in volumes of occipital lobes as determined by MRI.|Change in volume from 12 months of age scan in 24 months of age scan|Note that only subjects with usable MRI data are included in this analysis (this is a subset of all children completing the protocol).||percentage change||Standard Deviation|Mean
697362|NCT01367834|Primary|Total Brain Volume|Percent change in total brain volume as determined by magnetic resonance imaging (MRI)|Change in volume from 12 months of age scan in 24 months of age scan|Note that only subjects with usable MRI data are included in this analysis (this is a subset of all children completing the protocol).||percentage change||Standard Deviation|Mean
697363|NCT01367704|Primary|Change From Baseline to 3 Months Using the Intentions to Intervene Scale|Proclivity to intervene when witnessing disrespectful and harmful behaviors among peers comparing baseline and follow up mean scores, using a 5-point Likert-like scale ranging from “very unlikely” to “very likely” (minimum = 1 and maximum = 5). This scale was investigator developed by Miller (PI) et al to assess participants report of how likely they would be to do something to stop the behavior and modeled as a mean of 8 items.|3 months|||mean scores||Standard Deviation|Mean
697364|NCT01367704|Primary|Change From Baseline to 3 Months Using the Gender Equitable Attitudes Scale|Assessment of gender-equitable attitudes comparing baseline mean score with follow up mean score, using a 5-point Likert-like scale ranging from “strongly agree” to “strongly disagree” (minimum = 1 and maximum = 5). This scale includes questions modified from Barker’s Gender-Equitable Norms Scale and modeled as a mean of responses to 11 items.|3 months|||mean scores||Standard Deviation|Mean
697365|NCT01367704|Primary|Change From Baseline to 3 Months Using the Recognition of Abusive Behavior Scale|Recognition of disrespectful and harmful behaviors against girls as abusive comparing baseline and follow up mean scores, using a 5-point Likert-like scale ranging from “not abusive” to “extremely abusive” (minimum = 1 and maximum = 5). This scale was developed by Silverman et al to assess perceptions of the degree of abusiveness of specified relationship behaviors and modeled as a mean of responses to 12 items.|3 months|||mean scores||Standard Deviation|Mean
697366|NCT01367457|Primary|Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events were between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-serious adverse events (Non-SAEs).|Baseline to the 28 calendar days after the last administration of study drug (upto 80 months)|Safety population included all participants with RCC or MCL who received atleast 1 dose of study treatment.||participants|||Number
697367|NCT01367457|Primary|Overall Survival (OS)|Overall survival (OS) was defined as the interval from the day of the start of the treatment to death, or censored to the last date when the participant was identified to be alive.|From initiation of treatment untill death (up to 80 months)|Evaluable population included all participants with RCC or MCL who received atleast 1 dose of study treatment.||months||95% Confidence Interval|Median
697368|NCT01367457|Primary|Duration of Response (DOR)|Duration of response (DOR) was defined as the interval from the date the response was documented to the first date that progression of disease (PD) was observed in participants with PR or CR. RECIST criteria was used for participants with RCC and Cheson criteria for participants with MCL. PD, CR and PR are defined in primary outcome 1 and 2.|From initiation of treatment up to disease progression (up to 80 months)|Evaluable population included all participants with RCC or MCL who received atleast 1 dose of study treatment. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure.||months||95% Confidence Interval|Median
697369|NCT01367457|Primary|Percentage of Participants With Objective Response|Objective response: percentage of participants who achieved complete remission (CR) or partial response (PR). RECIST criteria was used for participants with RCC and Cheson criteria for participants with MCL. RECIST criteria (CR: disappearance of all target lesions, any pathological lymph nodes(target or non-target) reduced in short axis to <10 mm, PR: at least 30% decrease in sum of diameters of target lesions). Cheson criteria (CR: all lymph node masses regressed to normal size, each lymph node mass that was >1.5 cm in longest transverse dimension regressed to <=1.5 cm, lymph node mass that was 1.1-1.5 cm regressed to <=1 cm, complete disappearance of all radiographic evidence of disease, PR: at least 50% decrease in sum of products of the longest perpendicular dimensions of the previously identified dominant lymph node masses, no increase in size of other lymph nodes.)|From initiation of treatment up to disease progression (up to 80 months)|Evaluable population included all participants with RCC or MCL who received atleast 1 dose of study treatment.||percentage of participants|||Number
697370|NCT01367457|Primary|Progression-free Survival (PFS)|Progression-free survival: interval between start of treatment to first day when progressive disease (PD) was evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) for participants with RCC and Cheson criteria for participants with MCL, or death due to any cause. RECIST criteria: at least 20% increase in sum of diameters of target lesions, taking as reference the smallest sum. In addition to relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). Appearance of one or more new lesions also considered progression. Cheson criteria: appearance of any new sites of lymphoma OR at least 50% increase in product of longest perpendicular dimensions of any previously identified lymph node mass (LNM) OR at least 50% increase in longest dimension of any previously identified LNM greater than 1 cm in longest transverse dimension OR at least 50% increase in size of any previously involved site of lymphoma.|From initiation of treatment up to disease progression (up to 80 months)|Evaluable population included all participants with RCC or MCL who received atleast 1 dose of study treatment.||months||95% Confidence Interval|Median
697371|NCT01367249|Secondary|Ocular Pain|The proportion of subjects who were free of ocular pain at Day 1. Pain Free defined as a score of “None” on the pain scale of the Ocular Comfort Grading Assessment in the subject diary.|Day 1|LOCF Analysis, ITT Population||eyes|Participants||Number
697372|NCT01367249|Primary|Ocular Inflammation|The proportion of subjects who had cleared ocular inflammation summed ocular inflammation score (SOIS) of grade 0 by Day 15.|Day 15|LOCF Analysis, ITT Population||eyes|Participants||Number
697499|NCT01365611|Primary|Cmax (the Maximum Observed Plasma Concentration of Ketorolac Tromethamine)||PK parameters were determined using the following blood sampling times: pre-dose (within 10 minutes of ketorolac tromethamine administration), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 h post administration of study drug on Days 1 and 6|||ng/mL||Standard Deviation|Mean
697373|NCT01367158|Secondary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) After Vaccination|Solicited local and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.|From Day 1 to Day 7 after vaccination|Analysis was done on Safety Set (all subjects in the exposed set who provided post-vaccination solicited AE data).||Number of Subjects|||Number
697374|NCT01367158|Secondary|Numbers of Subjects With Other Unsolicited AEs|Unsolicited AEs were collected from Day 8 After vaccination Through Study Termination. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.|Day 8 After vaccination Through Study Termination, up to 6 months|Analysis was done on the Safety Set (all subjects in the exposed set who provided post-vaccination unsolicited AE data).||Number of Subjects|||Number
697375|NCT01367158|Secondary|Number of Subjects Reporting Unsolicited Adverse Events After Vaccination|Unsolicited AEs were collected with onset from Day 1 through Day 7 After Vaccination. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.|From Day 1 to Day 7 after vaccination|Analysis was done on the Safety Set (all subjects in the exposed set who provided post-vaccination unsolicited AE data).||Number of Subjects|||Number
697376|NCT01367158|Secondary|GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo|Antibody response was measured as Geometric Mean Ratios (95%CI) Against Serogroup B Test Strains after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, after 6 month of the first vaccination (6 month) in the parent study and after the third vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo|At month 1, 3, 6, 7 and 12|Analysis was done by MITT Set.||Ratio||95% Confidence Interval|Geometric Mean
697377|NCT01367158|Secondary|GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo|Antibody response was measured as Geometric Mean hSBA Titers Against Serogroup B Test Strains after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, after 6 month of the first vaccination (6 month) in the parent study and after the third vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo|At month 1, 3, 6, 7 and 12|Analysis was done by MITT Set.||Titers||95% Confidence Interval|Geometric Mean
697378|NCT01367158|Secondary|GMR Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo|Antibody response was measured as Geometric Mean Ratios (95%CI) Against Serogroup B Test Strains after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, after 6 month of the first vaccination (6 month) in the parent study and after the third vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo|At month 1, 3, 6, 7 and 12|Analysis was done by MITT Set.||Ratio||95% Confidence Interval|Geometric Mean
697379|NCT01367158|Secondary|GMT Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo|Antibody response was measured as Geometric Mean hSBA Titers Against Serogroup B Test Strains after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, after 6 month of the first vaccination (6 month) in the parent study and after the third vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo|At month 1, 3, 6, 7 and 12|Analysis was done by MITT Set.||Titers||95% Confidence Interval|Geometric Mean
697380|NCT01367158|Secondary|GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo|Antibody response was measured as Geometric Mean Ratios (95%CI) Against Serogroup B Test Strains after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, after 6 month of the first vaccination (month 6) in the parent study and after the third vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo|At month 1, 3, 6, 7 and 12|Analysis was done by MITT Set.||Ratio||95% Confidence Interval|Geometric Mean
697381|NCT01367158|Secondary|GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo|Antibody response was measured as Geometric Mean hSBA Titers Against Serogroup B Test Strains after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, After Third Vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo|At month 1, 3, 6, 7 and 12|Analysis was done by MITT Set.||Titers||95% Confidence Interval|Geometric Mean
697382|NCT01367158|Secondary|GMR for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo|Antibody response was measured as Geometric Mean Ratios (95%CI) Against N meningitidis Serogroups A, C, W and Y after after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, after 6 month of the first vaccination (6 month) in the parent study and after the third vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo|At month 1, 3, 6, 7 and 12|Analysis was done by Per MITT Set.||Ratio||95% Confidence Interval|Geometric Mean
697383|NCT01367158|Secondary|GMT for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo|Antibody response was measured as Geometric Mean hSBA Titers Against N meningitidis Serogroups A, C, W and Y after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, after 6 month of the first vaccination (6 month) in the parent study and after the third vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo.|At month 1, 3, 6, 7 and 12|Analysis was done by MITT Set.||Titers||95% Confidence Interval|Geometric Mean
697384|NCT01367158|Secondary|Percentages of Subjects With 4-fold Increase in hSBA Titers Against Serogroup B Test Strains at One Month After Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo|Antibody response was measured as the percentage of subjects with 4-fold Increase in human serum bactericidal assay (hSBA) titers and associated 95% CI, Against Serogroup B Test Strains at One Month After Third Vaccination (month 7) with One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo|At month 7|Analysis was done by MITT month 7 Set.||Percentages of subjects||95% Confidence Interval|Number
697385|NCT01367158|Secondary|Percentages of Subjects With Seroresponse Against N Meningitidis Serogroups A, C, W and Y at 1 Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo|Antibody response was measured as the percentage of subjects with seroresponse Against N meningitidis Serogroups A, C, W and Y, after pre and post vaccination at month 6 and after the third vaccination (month 7) with One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo. Seroresponse to N meningitidis serogroups A, C, W and Y is defined as: For subjects with a prevaccination hSBA <1:4, a postvaccination hSBA ≥1:8;For subjects with a prevaccination hSBA ≥1:4, an increase in hSBA titer of at least four times the prevaccination titer.|At month 7|Analysis was done by MITT month 7 Set.||Percentages of subjects||95% Confidence Interval|Number
697386|NCT01367158|Secondary|GMR for (95%CI) for N Meningitidis Against Serogroup B Test Strains at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo|Antibody response was measured as Geometric Mean Ratio (95% CI), against Serogroup B Test Strains at One Month After the Third Vaccination (month 7) with One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo|At month 7|Analysis was done by MITT Month 7 Set.||Ratio||95% Confidence Interval|Geometric Mean
697387|NCT01367158|Secondary|GMT for N Meningitidis Against Serogroup B Test Strains at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo|Antibody response was measured as Geometric Mean hSBA Titers Against Serogroup B Test Strains at 6 months following first vaccine during the parent study NCT01210885 and one month after third vaccination (Month 7) with One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo|At month 6 and month 7|Analysis was done by MITT Month 7 Set.||Titers||95% Confidence Interval|Geometric Mean
697388|NCT01367158|Secondary|Geometric Mean Ratio (GMR) for (95%CI) for N Meningitidis Serogroups A, C, W and Y at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo|Antibody response was measured as Geometric Mean Ratio (95% CI), against N meningitidis Serogroups A, C, W and Y at One Month After the Third Vaccination (month 7) With One of Four MenABCWY Formulations or rMenB|At month 7|Analysis was done by MITT Month 7 Set.||Ratio||95% Confidence Interval|Geometric Mean
697389|NCT01367158|Secondary|Geometric Mean Titers (GMT) for N Meningitidis Serogroups A, C, W and Y at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo|Antibody response was measured as Geometric Mean hSBA Titers against N meningitidis Serogroups A, C, W and Y at One of Four MenABCWY Formulations or rMenB at 6 months following first vaccine during the parent study NCT01210885 and one month after third vaccination (Month 7)|At month 6 and month 7|Analysis was done by MITT Month 7 Set.||Titers||95% Confidence Interval|Geometric Mean
697390|NCT01367158|Primary|Percentages of Subjects With hSBA ≥1:5 Against Serogroup B Test Strains at One Month After Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo|Antibody response was measured as the percentage of subjects with human serum bactericidal assay (hSBA) titers ≥1:5 and associated 95% CI, directed against to Serogroup B Test Strains at 6 months following first vaccine during the parent study NCT01210885 and one month after third vaccination (Month 7)|At month 6 and month 7|Analysis was done by MITT Month 7 Set.||Percentages of subjects||95% Confidence Interval|Number
697391|NCT01367158|Primary|Percentages of Subjects With hSBA ≥1:8 Against Serogroups A, C, W and Y at One Month After the Third Vaccination With Either One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo|Antibody response was measured as the percentage of subjects with human serum bactericidal assay (hSBA) titers ≥1:8 and associated 95% CI, directed against to N meningitidis serogroups A, C, W, and Y at 6 months following first vaccine during the parent study NCT01210885 and one month after third vaccination (Month 7).|At month 6 and month 7|Analysis was done by Modified Intention-To-Treat (MITT) Month 7 Set. MITT is defined as all subjects in the enrolled set who received a study vaccination at Month 6 and provided one evaluable serum sample at Month 7.||Percentages of subjects||95% Confidence Interval|Number
697392|NCT01367119|Secondary|Mean Post Anesthesia Recovery Side Effects|Post anesthesia recovery side effects were assessed at the time of discharge from recovery with five patient self-report items: nausea, headache, myalgia, visual disturbance, and confusion. These were rated by the patients on a four point scale (0, 1, 2, 3) – absent, mild, moderate, severe. This means that for each item a subject could score between 0 (no symptoms) and 3 (severe symptoms). Also, degree of recovery room agitation was rated by the nurse on a similar four point scale.|Time of discharge from recovery after ECT for each treatment, approximately 30 minutes after the end of the seizure|||units on a scale||Standard Deviation|Mean
697393|NCT01367119|Secondary|Mean Depression Rating Using the Patient Health Questionnaire-9 (PHQ-9)|"The PHQ-9 is the nine item depression scale of the Patient Health Questionnaire. The PHQ-9 is based directly on the diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual Fourth Edition (DSM-IV). Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 (no symptoms) and 27 (severe symptoms) for depression.
The questionnaire was administered to the subjects prior to the first treatment, the morning of the third treatment, the morning of the fifth treatment, and the morning of the seventh treatment. For subjects whos treatment series ws cancelled prior to a scheduled next administration of the rating scale, every effort was mde to administer them 2 days after the last treatment.
Means are reported overall across all treatments; p-values also take into account variability across treatments and within subject."|Baseline and after every second treatment for 7 treatments|Analysis was intent to treat; for the ketamine arm there were 65 observations, for the methohexital arm there were 63 observations.||units on a scale||Standard Deviation|Mean
697432|NCT01366534|Secondary|Number of Days Until the Onset of P. Falciparum Parasitemia Following Sporozoite Challenge|The onset of P. falciparum parasitemia was defined by a positive blood slide.|From day of challenge (Day 0) up to 159 days post-challenge|The analyses were performed on the According-to-Protocol (ATP) cohort for Efficacy, which included all evaluable subjects who did not use any medication or blood products forbidden by the protocol, who did not report any under lying medical condition influencing immune responses, for whom efficacy data were available.||Days||Standard Deviation|Mean
697394|NCT01367119|Primary|Mean Depression Rating Using the Hospital Anxiety and Depression Scale (HADS)|"The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 (no symptoms) and 42 (severe symptoms) for either anxiety or depression.
The questionnaire was administered to the subjects prior to the first treatment, the morning of the third treatment, the morning of the fifth treatment, and the morning of the seventh treatment. For subjects whose treatment series ws cancelled prior to a scheduled next administration of the rating scale, every effort was made to administer them 2 days after the last treatment.
Means are reported overall across all treatments; p-values also take into account variability across treatments and within subject."|Baseline and after every second treatment for 7 treatments|Analysis was intent to treat; for the ketamine arm there were 54 observations, for the methohexital arm there were 55 observations.||units on a scale||Standard Deviation|Mean
697395|NCT01367080|Secondary|t1/2|Terminal half-time(t1/2) of Amitryptyline in Plasma|Up to 72 hours|||hour||Standard Deviation|Mean
697396|NCT01367080|Secondary|Tmax|Time for Maximum Concentration(Tmax) of Amitryptyline in Plasma|Up to 72 hours|||hour||Standard Deviation|Mean
697397|NCT01367080|Secondary|Cmax|Maximum Concentration(Cmax) of amitryptyline in plasma|Up to 72 hours|||ng/mL||Standard Deviation|Mean
697398|NCT01367080|Primary|AUClast and AUCinf|Area Under the Plasma concentration-time curve from time Zero to Infinity(AUCinf) and Area Under the Plasma concentration-time curve from time Zero to last time(AUClast) of Amitryptiline in plasma|Up to 72 hours|||ng*hr/mL||Standard Deviation|Mean
697399|NCT01366976|Secondary|Serum Creatinine|Serum creatinine measured over a 72 hour period|72 hours|||mg/dL||Standard Error|Mean
697400|NCT01366976|Primary|Plasma F2-isoprostane Concentrations|Plasma F2-isoprostane concentrations as a measure of lipid peroxidation|24 hours|||pg/mL||Standard Error|Mean
697401|NCT01366976|Secondary|Urinary NGAL (Neutrophil Gelatinase-associated Lipocalin)|Changes in urinary NGAL (neutrophil gelatinase-associated lipocalin) as marker of acute kidney injury|24 hours|||ng/mL||Standard Error|Mean
697402|NCT01366976|Primary|Plasma Isofuran Concentrations|Plasma isofuran concentrations as a measure of lipid peroxidation|24 hours|||pg/mL||Standard Error|Mean
697403|NCT01366885|Secondary|Number of Mothers Who Developed Side Effects From Vitamin D|Mother will be followed by blood and urine screening for hypercalcemia and hypercalciuria which is the primary side effects of too much vitamin D.|During pregnancy and the 3 years of the child's development|The children born were assessed for whether they developed autism or not.||participants|||Number
697404|NCT01366885|Primary|Number of Children Who Developed Autism|The child will be screened by an Modified Checklist for Autism in Toddlers (MCHAT) interview at 18 months of age, and by a questionnaire, the Pervasive Developmental Disorder Behavioral Inventory (PDDBI) at 3 years of age to determine whether the child has developed autism or not.|Child assessed at 3 years of age|Children who developed autism||Children who developed autism|||Number
697405|NCT01366872|Secondary|Radiographic Predictors of Implant Failures and Poor Outcomes|Post-Operative radiographic disposition. Subsidence is described as the component sinking into the bone. Ingrowth is described as the implant components to conform into the tibia and talus.|A Minimum of 2 Years Post Index Procedure|Per protocol, patients who were completely revised were excluded.||participants|||Number
697406|NCT01366872|Secondary|Evaluation of Complication and Reoperation Rates|Number of reported complications/reoperations following the index procedure.|A Minimum of 2 Years Post Index Procedure|Per Protocol||participants|||Number
697407|NCT01366872|Primary|Assessment of Functional Outcomes Following Agility LP Ankle Replacement|Range of Motion - Combined total of dorsiflexion and plantarflexion. Full range of motion is described as 30 degrees or more. Partial limitation is described as 29 to 15 degrees. Range of motion that is less than 15 degrees is described as severely limited.|A Minimum of 2 Years Post Index Procedure|Per surgical history (protocol).||Degrees||Standard Deviation|Mean
697408|NCT01366846|Secondary|Number of Peanut Avoidance After Peanut Consumption Group Participants With Peanut Allergy (PA) at 60- and 72-month Visits Within in the Per Protocol Population|At 60 and 72 months of age, eligible participants were given an oral food challenge (intake of 5g of peanut protein in a single dose). Participants were considered to have no peanut allergy (PA) if they experienced no reaction following the food challenge. Those who did react were offered a double-blind, placebo-controlled food challenge with a total of 9.4g/13.7g (month 60/month 72) of peanut protein administered in increments. These participants were considered to have PA if they experienced a reaction at any point during the dose escalation. For participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on the results of a SPT and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have PA.|60 months and 72 months|Per Protocol||Participants|||Count of Participants
697409|NCT01366846|Secondary|Number of Participants With Peanut Allergy (PA) at 60- and 72-month Visits Within the Peanut Avoidance After Peanut Consumption Group|At 60 and 72 months of age, eligible participants were given an oral food challenge (intake of 5g of peanut protein in a single dose). Participants were considered to have no peanut allergy (PA) if they experienced no reaction following the food challenge. Those who did react were offered a double-blind, placebo-controlled food challenge with a total of 9.4g/13.7g (month 60/month 72) of peanut protein administered in increments. These participants were considered to have PA if they experienced a reaction at any point during the dose escalation. For participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on the results of a SPT and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have PA.|60 months and 72 months|Intent-to-treat||Participants|||Count of Participants
697433|NCT01366534|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Throughout the study period (Day 0 - Day 236)|The analyses were performed on the Intention-to-treat (ITT) cohort, which included all subjects with at least one vaccine administration documented. All challenged infectivity controls were also included in this cohort and presented as a separate group.||Participants|||Count of Participants
698981|NCT01349959|Other Pre-specified|Circulating DNA Evaluated Using QM-MSP|Data will also be graphically displayed showing trend in median values across time. Nonparametric Wilcoxon signed rank tests will be used to determine whether or not the data shows evidence of changes from baseline.|Up to 8 weeks||||||
697410|NCT01366846|Primary|Number of Participants With Peanut Allergy (PA) at 72 Months of Age – by Treatment Group in the Per Protocol Population|At 72 months of age, eligible participants were given an oral food challenge (oral intake of 5g of peanut protein in a single dose Participants were considered to have no peanut allergy (PA) if they experienced no reaction following the food challenge. Those who did react were offered a double-blind, placebo-controlled food challenge with a total of 13.7g of peanut protein administered in increments. These participants were to have PA if they experienced a reaction at any point during the dose escalation. For participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on the results of a SPT and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have PA.|72 months|Per Protocol||Participants|||Count of Participants
697411|NCT01366846|Primary|Number of Participants With Peanut Allergy (PA) at 72 Months of Age – by Skin Prick Test Stratum in the Per Protocol Population|At 72 months of age, eligible participants were given an oral food challenge (oral intake of 5g of peanut protein in a single dose Participants were considered to have no peanut allergy (PA) if they experienced no reaction following the food challenge. Those who did react were offered a double-blind, placebo-controlled food challenge with a total of 13.7g of peanut protein administered in increments. These participants were considered to have PA if they experienced a reaction at any point during the dose escalation. For participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on the results of a SPT and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have peanut allergy.|72 months|Per Protocol||Participants|||Count of Participants
697412|NCT01366846|Primary|Number of Participants With Peanut Allergy (PA) at 72 Months of Age – by Treatment Group|At 72 months of age, eligible participants were given an oral food challenge (oral intake of 5g of peanut protein in a single dose). Participants were considered to have no peanut allergy (PA) if they experienced no reaction following the food challenge. Those who did react were offered a double-blind, placebo-controlled food challenge with a total of 13.7g of peanut protein administered in increments. These participants were considered to have PA if they experienced a reaction at any point during the dose escalation. For participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on the results of a SPT and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have PA.|72 months|Intent-to-treat with available data at 72 Months||Participants|||Count of Participants
697413|NCT01366846|Primary|Number of Participants With Peanut Allergy (PA) at 72 Months of Age – by Skin Prick Test Stratum|At 72 months of age, eligible participants were given an oral food challenge (oral intake of 5g of peanut protein in a single dose). Participants were considered to not have peanut allergy (PA) if they experienced no reaction following the food challenge. Those who did react were offered a double-blind, placebo-controlled food challenge with a total of 13.7g of peanut protein administered in increments. These participants were considered to have PA if they experienced a reaction at any point during the dose escalation. For participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on the results of a SPT and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have PA.|72 months|Intent-to-treat with available data at 72 months||Participants|||Count of Participants
697414|NCT01366638|Primary|Plasma Concentrations of TMC435|"The table below shows the median (range) TMC435 predose plasma concentrations (C0h) and maximum concentration (Cmax) values for participants in each treatment group. “Overall” is the median exposure estimate using all available data for each participant in the study. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Overall (Up to Week 12)|Pharmacokinetic (PK) analysis was performed in the PK population, defined as all participants from whom sparse blood samples were drawn and who received at least 1 dose of study medication.||ng/mL||Full Range|Median
697415|NCT01366638|Primary|The Area Under the Plasma Concentration-Time Curve (From 0 to 24 Hours) (AUC24h)|"The table below shows the median (range) AUC24h values for TMC435 for all participants in each TMC435 treatment group who received TMC435 for up to 12 weeks. “Overall” is the median exposure estimate using all available data for each participant in the study. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Overall (Up to Week 12)|Pharmacokinetic (PK) analysis was performed in the PK population, defined as all participants from whom sparse blood samples were drawn and who received at least 1 dose of study medication.||ng·h/mL||Full Range|Median
697416|NCT01366638|Primary|The Percentage of Participants Who Met Response Guided Treatment (RGT) Criteria and Completed Treatment With Peginterferon Alpha-2b (PegIFNα-2b) and Ribavirin (RBV) at Week 24|"The table below shows the percentage of participants in each treatment group who met RGT criteria (ie, who had plasma levels of hepatitis C virus ribonucleic acid [HCV RNA] <1.2 log10 IU/mL detectable/undetectable at Week 4 and <1.2 log 10 IU/mL undetectable at Week 12) and completed treatment with PegIFNα-2b and RBV at Week 24. Participants in the TMC435 Treatment-Naïve and TMC435 Prior Relapser treatment groups not meeting RGT criteria continued treatment with PegIFNα-2a and RBV to Week 48 (does not apply to the TMC435 Non-responder treatment group because the specified treatment duration was 48 weeks and RGT criteria was not assessed at Week 24). NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Week 24 or 48|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.||Percentage of participants|||Number
697434|NCT01366534|Primary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within the 30-day (Day 0 - Day 29) follow-up period post-challenge|The analyses were performed on the Intention-to-treat (ITT) cohort, which included all subjects with at least one vaccine administration documented. All challenged infectivity controls were also included in this cohort and presented as a separate group.||Participants|||Count of Participants
697417|NCT01366638|Primary|The Percentage of Participants Who Achieved a Greater Than or Equal to 2 log10 IU/mL Drop From Baseline in Plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) at Each Time Point During Treatment and Follow-up|"The table below shows the percentage of participants in each treatment group with greater than or equal to 2 log10 IU/mL drop from baseline in plasma hepatitis C virus (HCV) ribonucleic acid (RNA) at each time point during treatment and post-treatment follow-up. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Day 3, Day 7 and Weeks 2, 3, 4, 8, 12, 16, 20, 24, 28, 36, 48, 60, 72, EOT (up to Week 24 or 48), follow-up (FU) Week 4, 12, and 24|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.||Percentage of participants|||Number
697418|NCT01366638|Primary|The Number of Participants With Abnormal Alanine Aminotransferase (ALT) Levels at Baseline Who Achieved Normal Limit of ALT at the End of Treatment (EOT)|"The table below shows the number of participants in each treatment group with abnormal ALT levels at Baseline who achieved normalization of ALT levels defined as having an ALT value less than or equal to the Upper Limit of Normality (ie, 40 IU/mL) at EOT. At Baseline, 15 treatment-naïve participants, 13 prior relapsers, and 13 prior non-responders had abnormal ALT levels at Baseline. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Up to Week 48|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.||Percentage of participants|||Number
697419|NCT01366638|Primary|The Number of Participants Demonstrating Viral Relapse|"The table below shows the number of participants in each treatment group who demonstrated viral relapse, defined as having undetectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels at end of treatment (EOT [Week 24 or 48]) and detectable HCV RNA during follow-up or detectable HCV RNA at the time points of an assessment of sustained virologic response (SVR). The number of participants analyzed in each treatment group below are those with undetectable HCV RNA levels at EOT and with at least one follow-up HCV RNA measurement. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Up to 72 weeks|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.||Participants|||Number
697420|NCT01366638|Primary|The Number of Participants With Viral Breakthrough|"The table below shows the number of participants in each treatment group who experienced viral breakthrough during the TMC435 treatment period. Viral breakthrough is defined as a confirmed increase of greater than 1 log10 IU/mL in plasma hepatitis C virus (HCV) ribonucleic acid (RNA) level from the lowest level reached or a confirmed value of plasma HCV RNA of greater than 2.0 log10 IU/mL in participants whose plasma HCV RNA level had previously been reported below 1.2 log10 IU/mL detectable or undetectable. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Up to 48 Weeks|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.||Participants|||Number
697421|NCT01366638|Primary|The Percentage of Participants With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) During Treatment and at the End of Treatment|"The table below shows the percentage of participants in each treatment group with undetectable HCV RNA less than 1.2 log10 IU/mL during treatment and at end of treatment (EOT). NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Weeks 4, 12, 24, 36, 48, 60, 72, and EOT (up to Week 48)|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.||Percentage of participants|||Number
697422|NCT01366638|Primary|The Percentage of Participants With a Sustained Virologic Response 24 Weeks After the Actual End of Treatment (SVR24)|"The table below shows the percentage of participants in each treatment group with a SVR24 defined as participants with undetectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) at the end of treatment and at 24 weeks after the last dose of treatment (Week 48 or 72). NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|24 weeks after the last dose of treatment (Week 48 or 72)|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.||Percentage of participants|||Number
697423|NCT01366638|Primary|The Percentage of Participants With a Sustained Virologic Response 12 Weeks After the Actual End of Treatment (SVR12)|"The table below shows the percentage of participants in each treatment group with an SVR12 defined as participants with undetectable plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) at the end of treatment (Week 24 or 48) who also had undetectable plasma HCV RNA 12 weeks after the last dose of treatment (Week 36 or 60). NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Week 36 or 60|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.||Percentage of Participants|||Number
697424|NCT01366534|Secondary|Frequency of CS-specific T-cells Producing IFN-γ|The analysis was performed via Enzyme-Linked Immunospot (ELISPOT) N-terminal assay. Data are presented as the number of spots per million peripheral blood mononuclear cells (PBMCs).|14 days post-dose 1 (Day 14)|The analyses were performed on the According-to-Protocol (ATP) cohort for Immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements, who did not report any underlying medical condition influencing immune responses and for whom immunogenicity data were available.||spots/million PBMCs||Standard Deviation|Mean
697425|NCT01366534|Secondary|Frequency of CS-specific T-cells Producing IFN-γ|The analysis was performed via Enzyme-Linked Immunospot (ELISPOT) full length assay. Data are presented as the number of spots per million peripheral blood mononuclear cells (PBMCs). Volunteers from Control Group did not receive any immunization, but were subjected to the sporozoite challenge, therefore the frequency for this group is presented as from Day 77.|14 days post-dose 1 (Day 14), 14 days post-dose 2 (Day 42), 21 days post-dose 3 (Day 77 = Day of challenge), 28 days post-challenge (Day 105), 63 days post-challenge (Day 140), 159 days post-challenge (Day 236)|The analyses were performed on the According-to-Protocol (ATP) cohort for Immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements, who did not report any underlying medical condition influencing immune responses and for whom immunogenicity data were available.||spots/million PBMCs||Standard Deviation|Mean
697426|NCT01366534|Secondary|Frequency of HBs-specific CD4+ T-cells|HB-specific CD4+ T-cells expressing at least 2 cytokines/activation markers between IL-2, IFN-γ, TNF-α and CD40-L are presented here. Analysis was performed via intra-cellular staining (ICS) assays, data are presented as frequency of T-cells per million peripheral blood mononuclear cells (PBMCs). Volunteers from Control Group did not receive any immunization, but were subjected to the sporozoite challenge, therefore the frequency for this group is presented as from Day 77.|14 days post-dose 1 (Day 14), 14 days post-dose 2 (Day 42), 21 days post-dose 3 (Day 77 = Day of challenge), 28 days post-challenge (Day 105), 63 days post-challenge (Day 140), 159 days post-challenge (Day 236)|The analyses were performed on the According-to-Protocol (ATP) cohort for Immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements, who did not report any underlying medical condition influencing immune responses and for whom immunogenicity data were available.||T-cells/million PBMCs||Standard Deviation|Mean
697427|NCT01366534|Secondary|Frequency of CS (Total CS or Repeat)-Specific CD8+ T Cells|CS-specific CD8+ T-cells expressing at least 2 cytokines/activation markers between IL-2, IFN-γ, TNF-α and CD40-L are presented here. Analysis was performed via intra-cellular staining (ICS) assays, data are presented as frequency of T-cells per million peripheral blood mononuclear cells (PBMC). Volunteers from Control Group did not receive any immunization, but were subjected to the sporozoite challenge, therefore the frequency for this group is presented as from Day 77.|14 days post-dose 1 (Day 14), 14 days post-dose 2 (Day 42), 21 days post-dose 3 (Day 77 = Day of challenge), 28 days post-challenge (Day 105), 63 days post-challenge (Day 140), 159 days post-challenge (Day 236)|The analyses were performed on the According-to-Protocol (ATP) cohort for Immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements, who did not report any underlying medical condition influencing immune responses and for whom immunogenicity data were available.||T-cells/million PBMCs||Standard Deviation|Mean
697428|NCT01366534|Secondary|Frequency of CS (Total CS or Repeat)-Specific CD4+ T-cells|CS-specific CD4+ T-cells expressing at least 2 cytokines/activation markers between IL-2, IFN-γ, TNF-α and CD40-L are presented here. Analysis was performed via intra-cellular staining (ICS) assays, data are presented as frequency of T-cells per million peripheral blood mononuclear cells (PBMCs).Volunteers from Control Group did not receive any immunization, but were subjected to the sporozoite challenge, therefore the frequency for this group is presented as from Day 77.|14 days post-dose 1 (Day 14), 14 days post-dose 2 (Day 42), 21 days post-dose 3 (Day 77 = Day of challenge), 28 days post-challenge (Day 105), 63 days post-challenge (Day 140), 159 days post-challenge (Day 236)|The analyses were performed on the According-to-Protocol (ATP) cohort for Immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements, who did not report any underlying medical condition influencing immune responses and for whom immunogenicity data were available.||T-cells/million PBMCs||Standard Deviation|Mean
697429|NCT01366534|Secondary|Anti-Adenovirus Type 35 (Ad35) Neutralizing Antibody Titers at Specified Time Points|Titers are presented as geometric mean titers (GMTs) and are measured in titers. Volunteers from Control Group did not receive any immunization, but were subjected to the sporozoite challenge, therefore GMTs for this group are presented as from Day 77.|28 days post-dose 1 (Day 28), 28 days post-dose 2 (Day 56), 21 days post-dose 3 (Day 77 = Day of challenge), 28 days post-challenge (Day 105), 63 days post-challenge (Day 140), 159 days post-challenge (Day 236)|The analyses were performed on the According-to-Protocol (ATP) cohort for Immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements, who did not report any underlying medical condition influencing immune responses and for whom immunogenicity data were available.||Titers||95% Confidence Interval|Geometric Mean
697430|NCT01366534|Secondary|Anti-hepatitis B (Anti-HBs) Antibody Titers|Titers are presented as geometric mean titers (GMTs) and are measured in titers. Volunteers from Control Group did not receive any immunization, but were subjected to the sporozoite challenge, therefore GMTs for this group are presented as from Day 77.|28 days post-dose 1 (Day 28), 28 days post-dose 2 (Day 56), 21 days post-dose 3 (Day 77 = Day of challenge), 28 days post-challenge (Day 105), 63 days post-challenge (Day 140), 159 days post-challenge (Day 236)|The analyses were performed on the According-to-Protocol (ATP) cohort for Immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements, who did not report any underlying medical condition influencing immune responses and for whom immunogenicity data were available.||Titers||95% Confidence Interval|Geometric Mean
697431|NCT01366534|Secondary|Anti-circumsporozoite Protein (Anti-CS) Antibody Titers|Titers are presented as geometric mean titers (GMTs) and are measured in titers. Volunteers from Control Group did not receive any immunization, but were subjected to the sporozoite challenge, therefore GMTs for this group are presented as from Day 77.|28 days post-dose 1 (Day 28), 28 days post-dose 2 (Day 56), 21 days post-dose 3 (Day 77 = Day of challenge), 28 days post-challenge (Day 105), 63 days post-challenge (Day 140), 159 days post-challenge (Day 236)|The analyses were performed on the According-to-Protocol (ATP) cohort for Immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements, who did not report any underlying medical condition influencing immune responses and for whom immunogenicity data were available.||Titers||95% Confidence Interval|Geometric Mean
697646|NCT01363700|Secondary|Mean Ocular Itching Score Compared to Olopatadine Period2|"A conjunctivitis allergic challenge (CAC) was performed 4 hours after drop instillation. Mean ocular itching score was assessed by the subject at 3, 5, and 10 min post challenge on a 5 points scale of 0-4 where 0=no itching and 4=incapacitating itch.
The endpoint used the average score of three time points (3, 5, and 10 minutes) after allergen challenge ."|Visit 7 (3, 5, and 10 minutes post-CAC)|||score||Standard Error|Mean
697435|NCT01366534|Primary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within the 30-day (Day 0 - Day 29) follow-up period post-vaccination|The analyses were performed on the Intention-to-treat (ITT) cohort, which included all subjects with at least one vaccine administration documented.||Participants|||Count of Participants
697436|NCT01366534|Primary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were chills, fatigue, gastrointestinal symptoms, headache and temperature [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade.Grade 3 Chills = rigors [uncontrollable shivering more than (>) 15 seconds]. Grade 3 Fatigue, Gastrointestinal symptoms and Headache = symptoms that prevented normal activity. Grade 3 fever = fever higher than (>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|Within the 7-day (Day 0 – Day 6) follow-up period post-vaccination|The analyses were performed on the Intention-to-treat (ITT) cohort, which included all subjects with at least one vaccine administration documented, who had their symptoms sheet filled in.||Participants|||Count of Participants
697437|NCT01366534|Primary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest, pain that prevented normal every day activities. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|Within the 7-day (Day 0 – Day 6) follow-up period post-vaccination|The analyses were performed on the Intention-to-treat (ITT) cohort, which included all subjects with at least one vaccine administration documented, who had their symptoms sheet filled in.||Participants|||Count of Participants
697438|NCT01366534|Primary|Number of Subjects With Plasmodium Falciparum Parasitemia Following Sporozoite Challenge|P. falciparum parasitemia was defined as a positive blood slide.|28 days following sporozoite challenge (Day 105)|The analyses were performed on the According-to-Protocol (ATP) cohort for Efficacy, which included all evaluable subjects who did not use any medication or blood products forbidden by the protocol, who did not report any under lying medical condition influencing immune responses, for whom efficacy data were available.||Participants|||Count of Participants
697439|NCT01366521|Secondary|Mean Dose Normalized Cmax Ratio to Assess the Relative Bioavailability of SC Mepolizumab as Compared With IV Mepolizumab|Maximum plasma concentration was estimated by population modelling techniques using non-linear mixed effect methods for the individual and population pharmacokinetic parameters from the sparse sampling. Log-transformed dose-normalized (DM) Cmax were be analyzed using an analysis of variance (ANOVA) model. The ratio for each SC dose group versus IV and across SC doses versus IV will be estimated from the model together with associated 90% confidence intervals. Blood samples for PK analyses of mepolizumab were collected on dosing days (Days 1, 28 and 56) at pre-dose and 0.5 h, 1 h and 2 h post-dose (time was relative to the end of infusion in the IV cohort) as well as on Days 3, 7, 70, 84, 112 and 140 (follow-up visit).|Days 1, 3, 7, 28, 56, 70, 84, 112 and 140|PK Population. Only those participants available at the indicated time points were analyzed (represented by n=X, X, X, X in the category titles).||Percentage||90% Confidence Interval|Mean
697440|NCT01366521|Secondary|Mean AUC to Assess the Absolute Bioavailability of SC Mepolizumab|Population modelling techniques using non-linear mixed effect methods were used to estimate individual and population pharmacokinetic parameters from the sparse sampling. Log-transformed individual clearance estimates were analysed using an analysis of variance (ANOVA) model. The absolute bioavailability for each SC dose group and across SC doses will be estimated from the model together with associated 90% confidence intervals. Blood samples for PK analyses were collected on dosing days (Days 1, 28 and 56) at pre-dose and 0.5 h, 1 h and 2 h post-dose (time was relative to the end of infusion in the IV cohort) as well as on Days 3, 7, 70, 84, 112 and 140 (follow-up visit).|Days 1, 3, 7, 28, 56, 70, 84, 112 and 140|PK Population||Percentage||90% Confidence Interval|Mean
697441|NCT01366521|Secondary|Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Screening and Day 3|The number of participants with normal, abnormal - clinically significant (CS), and abnormal - not clinically significant (NCS) ECG findings, as well as the number of participants with no results (NR), at Screening (SCR) and Day 3 are presented. Findings were determined to be normal, abnormal CS, and NCS by the investigator.|Screening (SCR) and at Day 3|Safety Population||Participants|||Number
697442|NCT01366521|Secondary|Number of Participants With Levels of Anti-mepolizumab Antibodies at Indicated Time Points|Blood samples were collected for the determination of anti-mepolizumab antibodies by antibody detection (AD) and antibody neutralisation (AN) assay. For participants who prematurely withdrew from the study and had been dosed, immunogenicity testing occurred (if possible) at the time of premature withdrawal and at 16 weeks after dosing (or the end of the study, whichever came first). Serum was tested for the presence of anti-mepolizumab antibodies using the currently approved analytical methodology incorporating screening, confirmation and titration steps. Samples confirmed positive for the presence of anti-mepolizumab antibodies in the original assay were tested for the presence of neutralizing antibodies.|Day 1, Day 112 and Day 140|Safety Population. Only those participants available at the indicated time points were analyzed (represented by n=X, X, X, X in the category titles).||Participants|||Number
697443|NCT01366521|Secondary|Change From Baseline in Heart Rate Assessed at Baseline, Day 1, Day 28, Day 56, Day 84, Day 112 and Day 140|Vital sign measurements including heart rate (HR) was measured at Baseline (Pre-dose Day 1), Day 1 (30 minutes, 1 h, 2 h), Day 28 (pre-dose, 30 minutes, 1 h, 2 h), Day 56 (pre-dose, 30 minutes, 1 h, 2 h), Day 84, Day 112 and follow-up (Day 140).|Baseline (Day 1 pre-dose) and at Day 1, Day 28, Day 56, Day 84, Day 112 and Day 140|Safety Population. Only those participants available at the indicated time points were analyzed (represented by n=X, X, X, X in the category titles).||beats per minute (BPM)||Standard Deviation|Mean
697905|NCT01362244|Secondary|Absolute Values of the Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count (RC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25|RBC count and RC were assessed at Weeks 1, 2, 5, 9, 13, 17, 21, and 25.|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Safety Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.||10^12 cells per litre||Standard Deviation|Mean
697444|NCT01366521|Secondary|Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Assessed at Baseline, Day 1, Day 28, Day 56, Day 84, Day 112 and Day 140|Vital sign measurements including systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured at Baseline (pre-dose Day 1), Day 1 (30 minutes, 1 h, 2 h), Day 28 (pre-dose, 30 minutes, 1 h, 2 h), Day 56 (pre-dose, 30 minutes, 1 h, 2 h), Day 84, Day 112 and follow-up (Day 140).|Baseline (Day 1 pre-dose) and at Day 1, Day 28, Day 56, Day 84, Day 112 and Day 140|Safety Population. Only those participants available at the indicated time points were analyzed (represented by n=X, X, X, X in the category titles).||Millimeter of mercury (mmHg)||Standard Deviation|Mean
697445|NCT01366521|Secondary|Number of Participants With Hematology Laboratory Parameters Outside the Normal Range at Following Treatment|Hematology laboratory parameters included platelet count, red blood cells (RBC) count, white blood cell (WBC) count, hemoglobin, hematocrit, reticulocyte count, mean corpuscle volume (MCV), mean corpuscle hemoglobin (MCH), mean corpuscle hemoglobin concentration (MCHC), neutrophils, segmented neutrophils (SN), total neutrophils (TN), lymphocytes, monocytes, eosinophils and basophils assessed at Baseline, Weeks 4, 8, 12 and 20. Hematology abnormalities outside the normal range (high and low values) at any time post-Baseline are presented.|Days 1, 3, 7, 28, 56, 70, 84, 112 and 140 (follow-up visit)|Safety Population||Participants|||Number
697446|NCT01366521|Secondary|Number of Participants With Clinical Chemistry Parameters Outside the Normal Range Following Treatment|Clinical chemistry laboratory parameters included blood urea nitrogen (BUN), potassium, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin (TB) and direct bilirubin, creatinine, chloride, uric acid, glucose, total carbondioxide (CO2), gamma glutamyltransferase (GGT), albumin, sodium, calcium, alkaline phosphatase (ALP) and total protein assessed at Baseline, Weeks 4, 8, 12 and 20. Laboratory abnormalities outside the normal range (high and low values) at any time post-Baseline are presented.|Baseline (Day 1 pre-dose), Weeks 4, 8, 12 and 20|Safety Population: all participants randomized to treatment who received at least one dose of study medication. Only those participants available at the indicated time points were analyzed (represented by n=X, X, X, X in the category titles).||Participants|||Number
697447|NCT01366521|Primary|Terminal Half-life (t½) From Pre-dose (Day 1) to Day 140 for Mepolizumab|Terminal half-life (t1/2) was estimated by modelling techniques using non-linear mixed effect methods for the individual and population pharmacokinetic parameters for mepolizumab from the sparse sampling. Blood samples for PK analyses of mepolizumab were collected on dosing days (Days 1, 28 and 56) at pre-dose and 0.5 h, 1 h and 2 h post-dose (time was relative to the end of infusion in the IV cohort) as well as on Days 3, 7, 70, 84, 112 and 140 (follow-up visit).|Days 1, 3, 7, 28, 56, 70, 84, 112 and 140|PK Population||Days||95% Confidence Interval|Mean
697448|NCT01366521|Primary|Time to Maximum Plasma Concentration (Tmax) From Pre-dose (Day 1) to Day 140 for Mepolizumab|Time to maximum plasma concentration was estimated by population modelling techniques using non-linear mixed effect methods for the individual and population pharmacokinetic parameters from the sparse sampling. Blood samples for PK analyses of mepolizumab were collected on dosing days (Days 1, 28 and 56) at pre-dose and 0.5 h, 1 h and 2 h post-dose (time was relative to the end of infusion in the IV cohort) as well as on Days 3, 7, 70, 84, 112 and 140 (follow-up visit).|Days 1, 3, 7, 28, 56, 70, 84, 112 and 140|PK Population. Only those participants with the blood samples available at the indicated time points were analyzed (represented by n=X, X, X, X in the category titles).||hours||Full Range|Median
697449|NCT01366521|Primary|Maximum Plasma Concentration (Cmax) From Pre-dose (Day 1) to Day 140 for Mepolizumab|Maximum plasma concentration was estimated by population modelling techniques using non-linear mixed effect methods for the individual and population pharmacokinetic parameters from the sparse sampling. Blood samples for PK analyses of mepolizumab were collected on dosing days (Days 1, 28 and 56) at pre-dose and 0.5 h, 1 h and 2 h post-dose (time was relative to the end of infusion in the IV cohort) as well as on Days 3, 7, 70, 84, 112 and 140 (follow-up visit).|Days 1, 3, 7, 28, 56, 70, 84, 112 and 140|PK Population. Only those participants with the blood samples available at the indicated time points were analyzed (represented by n=X, X, X, X in the category titles).||Nanogram per milliliter (ng/mL)||95% Confidence Interval|Geometric Mean
697450|NCT01366521|Primary|Mean Area Under the Plasma-concentration Time Curve (AUC) Following SC and IV Administration of Mepolizumab|AUC of mepolizumab was estimated by population modeling techniques using non-linear mixed effect methods for the individual and population pharmacokinetic parameters from the sparse sampling. Individual cumulative plasma of mepolizumab AUC to Day 84 (cumAUC(0-day 84)), is the sum of the AUCs over each dosing interval after each of the three doses administered, for those participants with data up to Day 84. Individual cumulative plasma of mepolizumab AUC to Day 140 (cumAUC(0-day 140) is the sum of the AUCs over each dosing interval after each of the three doses administered plus the AUC post the last dose interval up to Day 140 (i.e. from Day 84 to Day 140). Blood samples for PK analyses were collected on dosing days (Days 1, 28 and 56) at pre-dose and 0.5 hour (h), 1 h and 2 h post-dose (time was relative to the end of infusion in the IV cohort) as well as on Days 3, 7, 70, 84, 112 and 140 (follow-up visit).|Days 1, 3, 7, 28, 56, 70, 84, 112 and 140|Pharmacokinetic (PK) Population: all participants randomized to treatment and who received at least one dose of study treatment and who have at least one PK sample taken and analyzed. Only those participants with the blood samples available at the indicated time points were analyzed (represented by n=X, X, X, X in the category titles).||Nanogramper milliliter per hour(ng*h/mL)||95% Confidence Interval|Geometric Mean
697451|NCT01366521|Primary|Number of Participants Who Achieved >=50% Eosinophil Repletion by Day 140|This summarizes the number of participants who returned to at least 50% of their Baseline blood eosinophil levels after maximum inhibition had been achieved and without any subsequent decrease in blood eosinophil levels. Blood samples were collected at Days 1, 3, 7, 28, 56, 70, 84, 112 and 140.|Days 1, 3, 7, 28, 56, 70, 84, 112 and 140|PD Population||Participants|||Number
697452|NCT01366521|Primary|Time to Maximum Change in Blood Eosinophils Levels (Tmaxeos)|Blood samples were collected at Days 1, 3, 7, 28, 56, 70, 84, 112 and 140 to assess the time to first occurrence of maximum reduction from baseline in blood eosinophil levels between Day 1 pre-dose and last quantifiable study measurement.|Days 1, 3, 7, 28, 56, 70, 84, 112 and 140|PD Population.||Days||95% Confidence Interval|Mean
697906|NCT01362244|Secondary|Absolute Values of the Hematology Parameters of Hemoglobin and Mean Corpuscular Hemoglobin Concentration (MCHC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Hemoglobin and MCHC were assessed at Weeks 1, 2, 5, 9, 13, 17, 21, and 25.|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Safety Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.||Grams per liter (g/L)||Standard Deviation|Mean
697453|NCT01366521|Primary|Maximum Change From Baseline in Blood Eosinophils (Emax)|Blood samples were collected at Days 1, 3, 7, 28, 56, 70, 84, 112 and 140 to assess the maximum reduction from Baseline in blood eosinophils between Day 1 pre-dose and last quantifiable study measurement. Change from Baseline was calculated as the ratio of the post-Baseline value divided by the Baseline value. The maximum reduction from Baseline in eosinophils is represented by the minimum ratio to Baseline.|Days 1, 3, 7, 28, 56, 70, 84, 112 and 140|PD Population||Giga units per liter (GI/L)||95% Confidence Interval|Geometric Mean
697454|NCT01366521|Primary|Area Under the Blood Eosinophil Time Curve (AUEC) up to Day 84|Area under the absolute blood eosinophil time curve to Day 84 (AUECeos[0-day 84]) determined using the linear trapezoidal rule for subset of participants with blood eosinophil data to Day 84. Blood samples for the analyses of AUEC(eos) (0-day 84) were collected at Days 1, 3, 7, 28, 56, 70 and 84.|Days 1, 3, 7, 28, 56, 70 and 84|PD Population. Only participants with eosinophil data to Day 84 were analyzed.||Giga unit per liter per day (GI*d/L)||95% Confidence Interval|Geometric Mean
697455|NCT01366521|Primary|Change From Baseline in Blood Eosinophil Levels at Week 12 (Day 84)|Change from Baseline in blood eosinophils was calculated as the post-Baseline value minus the Baseline value. The change from Baseline in log-transformed blood eosinophil levels at Week 12 was analyzed using both a linear and non-linear (Imax) dose response models. The dose response was found to be non-linear and hence only the results of the non-linear model are presented. Mepolizumab 75mg IV assumed to equate to 100 mg SC within model. Prior to log10-transformation, zero values were imputed with half the minimum value across all dose groups and time points. An adjustment for Baseline eosinophil count was also incorporated into the model.|Baseline (Day 1 pre-dose) and Week 12|Pharmacodynamic (PD) Population: all participants randomized to treatment and who received at least one dose of study medication and who also had a Baseline PD or biomarker measurement and at least one post-treatment PD or biomarker measurement. Only participants who were available at the specified time point were analyzed.||Proportion of Baseline blood eosinophil||95% Confidence Interval|Number
697456|NCT01366443|Primary|Pregnant Women Positive and Negative for Membrane Rupture Measured Via Clinical Assessment, Chart Review and ROM Plus|Patients underwent two assessments to determine positive or negative membrane rupture status: (1) Standard clinical assessment using fluid leaking from the cervical os, or two of the following; pooling, positive nitrazine test, or ferning and (2) A new combination immunoassay ROM Plus containing a combination of monoclonal and polyclonal antibodies to Placental Protein 12 (PP12) and Alpha-fetoprotein (AFP). Then, membrane rupture status was determined by chart review for reference based on a post delivery patient chart review by an experienced physician blinded to ROM Plus results.|1 week|Healthy pregnant women between 15 or greater weeks gestation reporting with signs or symptoms of rupture of membranes who underwent all three assessments.||participants|||Number
697457|NCT01366417|Primary|Antimicrobial Efficacy|Antimicrobial efficacy will be measured by the change (+/-) in bacterial count on the skin 10 minutes after a single application of test material relative to the baseline bacterial count.|10 minutes after treatment|Subjects whose Treatment Day Baseline bacterial counts met qualification criteria||log 10 colony forming units / cm^2||95% Confidence Interval|Mean
697458|NCT01366417|Primary|Antimicrobial Efficacy|Antimicrobial efficacy will be measured by the change (+/-) in bacterial count on the skin 30 seconds after a single application of test material relative to the baseline bacterial count.|30 seconds after treatment|subjects whose treatment day baseline microbial count met the qualification criteria and completed all assessments.||log 10 colony forming units / cm^2||95% Confidence Interval|Mean
697459|NCT01366209|Primary|Change in Percent Predicted Forced Vital Capacity (%FVC) From Baseline to Week 52||52 weeks|Intent to Treat all randomized Patient||percentage of patients|||Number
697460|NCT01366196|Secondary|Oral Analgesic Supplementation Use|Tabulate number of patients that used supplemental oral analgesics|Day of surgery|||Participants|||Count of Participants
697461|NCT01366196|Primary|Patient Controlled Analgesia (PCA) Hydromorphone Usage||Postoperative day 1|||mL||Standard Deviation|Mean
697462|NCT01366092|Secondary|Immunologic Effects of Low-dose Daily SC IL-2: Treg/Tcon Ratio|Blood samples were collected throughout the patient's 12 weeks of IL-2 treatment and after the 4 week hiatus. The ratio between CD4+CD25+FOXP3+ regulatory T cells (Treg) and CD4 conventional T cell (Tcon) counts were measured.|16 weeks of study follow-up|||ratio||Inter-Quartile Range|Median
697463|NCT01366092|Secondary|Immunologic Effects of Low-dose Daily SC IL-2: Treg Cell Counts|Blood samples were collected throughout the patient's 12 weeks of IL-2 treatment and after the 4 week hiatus. The CD4+CD25+FOXP3+ regulatory T cells (Treg) counts were measured.|16 weeks of study follow-up|||cell count/ uL||Inter-Quartile Range|Median
697464|NCT01366092|Secondary|Overall Survival and Progression-free Survival|Overall survival (OS) and progression-free survival (PFS) were calculated using the Kaplan-Meier method. OS was defined as from the study entry to death from any cause. Patients who were alive or lost to follow-up were censored at the time last seen alive. PFS was defined from the study entry to disease relapse or progression or death from any cause, whichever occurred first.|2 years from start of IL-2|||probability|||Number
697465|NCT01366092|Secondary|Prednisone Taper With IL-2 Therapy|Participants had their steroid dose assessed at weeks 6, 12,16, and every 8 weeks while on extended duration IL-2 therapy.|End of treatment after 16 weeks or most recent follow-up date for patients on extended|Participant's steroid taper was measured using their steroid dose at the start of therapy and their dose at the end of 16 weeks. For participants who continued on extended duration therapy, their final steroid dose was determined at the time of stopping treatment or, if still ongoing, the last clinic visit at the time of data analysis.||percent taper||Full Range|Mean
697466|NCT01366092|Secondary|Toxicity of 12-week Course of Low-dose SC IL-2 Therapy|Participants were evaluated at clinical visits for toxicities related to IL-2 throughout their 12-week treatment course|12 weeks|Grade 2 or higher, related to IL-2, adverse events (AE) were recorded for participants during their 12-week IL-2 treatment course. AE's were evaluated based on the CTCAE version 4.0.||Grade 2 or higher related AEs|||Number
697482|NCT01365650|Primary|MRT (the Mean Residence Time)|PK analysis by standard model was performed by a pharmacokineticist using model-independent analysis methods in WinNonlin Professional. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each time, together with individual plasma concentrations of ketorolac.|Blood samples for PK analyses were obtained at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 hours post administration of ketorolac tromethamine|||hours||Standard Deviation|Mean
697467|NCT01366092|Primary|Overall Response Rate of Low-dose Daily SC IL-2 in Steroid-refractory cGVHD|Participants were evaluated according to the cGVHD NIH Consensus criteria at baseline, 6 weeks, and 12 weeks on study. Per cGVHD NIH Consensus criteria, cGVHD involved organ systems are given a grade 0-3 and an overall cGVHD score, from 0-10, is given. Complete Response is defined as resolution of all reversible manifestations in each organ or site of cGVHD. A partial response is defined as an improvement in measure at least one organ or site, or decrease in global ratings by at least a 2-point change on the 10-point scale, without progression measured at any other organ or site. Non-responders have no change in cGVHD meeting criteria for either partial response or disease progression. Progressive disease is defined as an increase in organ or site scales (1-point change on a 3-point scale) or 2- to 3-point increase on the global cGVHD ratings. Clinical worsening of cGVHD is not synonymous with progressive cGVHD per NIH criteria.|Baseline, 6 weeks, and 12 weeks|33 of 35 patients were evaluable for response criteria. To be evaluable, patients had to receive at least 6 weeks of daily IL-2 and had their disease re-assessed.||participants|||Number
697468|NCT01365910|Secondary|Number of Patients With Each Worst‐Grade Toxicity|"Count of patients according to the worst‐grade toxicity experienced by each, where worst‐grade toxicity is per NCI common toxicity criteria: grade 1= mild; grade 2 = moderate; grade 3 = severe; grade 4 = life‐threatening; grade 5 = death
Assessed: days 1 &15 of cycle 1; day 1 of each subsequent 28-day cycle; at 30-day follow-up for two years"|date on‐study up to 2 years following final dose of study|Total number of patients reported with any toxicity||participants|||Number
697469|NCT01365910|Secondary|Overall Survival|Estimated probable duration of life from on‐study date to date of death from any cause, using the Kaplan‐Meier method with censoring.|Every 3 months, up to 2 years|All patients are included in the analysis on intention‐to-treat basis. Analysis is by Kaplan‐Meier method, where death is an event, with censoring for non‐expired patients at greater of off‐study date or last known alive date.||days||95% Confidence Interval|Median
697470|NCT01365910|Secondary|Progression-free Survival|Estimated probable duration of life without disease progression, from on‐study date to earlier of progression date or date of death from any cause, using the Kaplan‐Meier method with censoring. Disease progression is defined under RECIST v1.1 as >=20% increase in sum of longest diameters of target lesions, unequivocal progression of non‐target lesions, or appearance of new lesions.|Every 3 months, up to 2 years|All patients are included in the analysis on intention‐to-treat basis. Analysis is by Kaplan‐Meier method, where either death or progression is an event, with censoring for non‐progressed, non‐expired patients at greater of off‐study date or last known alive date.||days||95% Confidence Interval|Median
697471|NCT01365910|Primary|Overall Response Rate (Complete Response + Partial Response) With a Target of at Least 15%|Per Response Evaluation in Solid Tumors (RECIST) criteria v. 1.1: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) > 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions. Defined as the CR + PR recorded from the start of the treatment until disease progression/recurrence, the exact two-sided 95% confidence intervals will be reported.|Baseline and every 8 weeks, up to 2 years|All patients are included in the analysis on intention‐to-treat basis. Analysis is by Kaplan‐Meier method, where death is an event, with censoring for non‐expired patients at greater of off‐study date or last known alive date.||percentage of target lesions||95% Confidence Interval|Median
697472|NCT01365845|Secondary|Assessment of Cardiac Function Markers|Assess levels of cardiac function markers Troponin and Brain Naturietic Peptide before and after treatment.|after treatment||||||
697473|NCT01365845|Secondary|Assessment of Longterm Side Effects and Disease Specific End Points.|"Assess late toxicities including clinical and sub-clinical heart disease, pulmonary fibrosis, soft tissue fibrosis, rib fracture, and secondary malignancies.
Analyze local control, progression-free survival, and overall survival."|1 month following completion of treatment, then every 6 months for 5 years, then annually thereafter.||||||
697474|NCT01365845|Secondary|Assessment of Acute Side Effects|Assess acute toxicities including pericarditis, pneumonitis, dermatitis, fatigue, and nausea.|Participants will be assessed weekly during radiation therapy for an expected average of 7 weeks.||||||
697475|NCT01365845|Secondary|Secondary Dosimetric Endpoint|Assess improvements in other dosimetry endpoints including lung dose (mean lung dose, V20, V5), heart dose (mean heart, V20, V5), mean dose to the thyroid, mean esophageal dose, D95 coverage for axillary, supraclavicular and internal mammary nodes, maximal spinal cord dose (Dmax) and skin Dmax.|2 weeks prior to starting radiation therapy.||||||
697476|NCT01365845|Primary|Volume of Heart Receiving ≥ 5 Gray (Gy)/Cobalt Gray Equivalent (CGE)|A reduction of 50% in heart volume exposed to radiation doses ≥ 5 Gy/CGE was considered preferred outcome in this study plan.|2 weeks prior to starting radiation therapy.|||% of heart receiving >= 5 Gray (Gy)||Full Range|Median
697477|NCT01365819|Other Pre-specified|Reduction in Cigarette Smoking|3) To determine whether varenicline reduces cigarette smoking more than placebo among cigarette smoking MA dependent participants.|9 weeks||||||
697478|NCT01365819|Other Pre-specified|Reduced MA Withdrawal Symptoms|2) To determine whether varenicline reduces MA withdrawal symptoms more than placebo among MA- dependent participants over the course of the trial.|9 weeks||||||
697479|NCT01365819|Other Pre-specified|Delayed Time to Relapse|1) To determine whether varenicline reduces MA use and delays time to MA relapse more than placebo among MA dependent participants during the outpatient treatment period.|7 weeks||||||
697480|NCT01365819|Secondary|Number of Days Retained in Trial|Secondary aims will compare treatment retention, MA withdrawal symptoms, cognitive function, and cigarette smoking among participants randomly assigned to receive varenicline or placebo|9 weeks||||||
697481|NCT01365819|Primary|End of Treatment Abstinence|The primary analysis will compare two weeks continuous MA abstinence at end of treatment during weeks 8 and 9 among participants randomly assigned to receive varenicline versus those randomly assigned to receive placebo.|9 weeks|||Participants|||Count of Participants
697497|NCT01365611|Primary|AUC 0-t (the Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Last Quantifiable Time Point Post-dose of Ketorolac Tromethamine).||PK parameters were determined using the following blood sampling times: pre-dose (within 10 minutes of ketorolac tromethamine administration), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 h post administration of study drug on Days 1 and 6|||ng*hours/mL||Standard Deviation|Mean
697483|NCT01365650|Primary|t1/2z (the Terminal Half-life, Where Possible)|PK analysis by standard model was performed by a pharmacokineticist using model-independent analysis methods in WinNonlin Professional. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each time, together with individual plasma concentrations of ketorolac.|Blood samples for PK analyses were obtained at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 hours post administration of ketorolac tromethamine|||hours||Standard Deviation|Mean
697484|NCT01365650|Primary|AUC 0-∞ (the AUC From Time Zero to Infinity, Where Possible)|PK analysis by standard model was performed by a pharmacokineticist using model-independent analysis methods in WinNonlin Professional. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each time, together with individual plasma concentrations of ketorolac.|Blood samples for PK analyses were obtained at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 hours post administration of ketorolac tromethamine|||ng*h/mL||Standard Deviation|Mean
697485|NCT01365650|Primary|AUC 0-t (the Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Last Quantifiable Time Point Post-dose)|PK analysis by standard model was performed by a pharmacokineticist using model-independent analysis methods in WinNonlin Professional. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each time, together with individual plasma concentrations of ketorolac.|Blood samples for PK analyses were obtained at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 hours post administration of ketorolac tromethamine|||ng*h/mL||Standard Deviation|Mean
697486|NCT01365650|Primary|Tmax (the Time to Maximum Concentration)|PK analysis by standard model was performed by a pharmacokineticist using model-independent analysis methods in WinNonlin Professional. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each time, together with individual plasma concentrations of ketorolac.|Blood samples for PK analyses were obtained at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 hours post administration of ketorolac tromethamine|||hours||Full Range|Median
697487|NCT01365650|Primary|Cmax (the Maximum Observed Plasma Concentration)|PK analysis by standard model was performed by a pharmacokineticist using model-independent analysis methods in WinNonlin Professional. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each time, together with individual plasma concentrations of ketorolac.|Blood samples for PK analyses were obtained at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 hours post administration of ketorolac tromethamine|||ng/mL||Standard Deviation|Mean
697488|NCT01365624|Primary|MRT (Mean Residence Time)||Blood samples for PK analyses were obtained at pre-dose (15 minutes prior to ketorolac administration), 15 minutes, 30 minutes, 45 minutes, 1 hour, 1 hour and 30 minutes, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours and 24 hours post-dose|Two subjects had abnormally low plasma ketorolac concentration-time profiles that were inconsistent with the rest of the elderly population.||hours||Standard Deviation|Mean
697489|NCT01365624|Primary|t1/2z (Terminal Half-life)||Blood samples for PK analyses were obtained at pre-dose (15 minutes prior to ketorolac administration), 15 minutes, 30 minutes, 45 minutes, 1 hour, 1 hour and 30 minutes, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours and 24 hours post-dose|Two subjects had abnormally low plasma ketorolac concentration-time profiles that were inconsistent with the rest of the elderly population.||hours||Standard Deviation|Mean
697490|NCT01365624|Primary|AUC (Area Under the Plasma Concentration-time Profile From Time 0 to Infinity||Blood samples for PK analyses were obtained at pre-dose (15 minutes prior to ketorolac administration), 15 minutes, 30 minutes, 45 minutes, 1 hour, 1 hour and 30 minutes, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours and 24 hours post-dose|Two subjects had abnormally low plasma ketorolac concentration-time profiles that were inconsistent with the rest of the elderly population.||ng*hours/mL||Standard Deviation|Mean
697491|NCT01365624|Primary|AUClast (Area Under the Plasma Concentration-time Profile From Time Zero to the Last Quantifiable Time Point Post-dose||Blood samples for PK analyses were obtained at pre-dose (15 minutes prior to ketorolac administration), 15 minutes, 30 minutes, 45 minutes, 1 hour, 1 hour and 30 minutes, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours and 24 hours post-dose|||ng*hours/mL||Standard Deviation|Mean
697492|NCT01365624|Primary|Tmax (Time to Reach Maximum Plasma Concentration)||Blood samples for PK analyses were obtained at pre-dose (15 minutes prior to ketorolac administration), 15 minutes, 30 minutes, 45 minutes, 1 hour, 1 hour and 30 minutes, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours and 24 hours post-dose|||hours||Full Range|Median
697493|NCT01365624|Primary|Cmax (Maximum Plasma Concentration)||Blood samples for PK analyses were obtained at pre-dose (15 minutes prior to ketorolac administration), 15 minutes, 30 minutes, 45 minutes, 1 hour, 1 hour and 30 minutes, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours and 24 hours post-dose|||ng/mL||Standard Deviation|Mean
697494|NCT01365611|Primary|MRT (the Mean Residence Time of Ketorolac Tromethamine, Where Possible)||PK parameters were determined using the following blood sampling times: pre-dose (within 10 minutes of ketorolac tromethamine administration), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 h post administration of study drug on Days 1 and 6|The half-life could not be estimated for a subject due to the nature of the subject's PK profile.||hours||Standard Deviation|Mean
697495|NCT01365611|Primary|t1/2z (the Terminal Half-life of Ketorolac Tromethamine, Where Possible)||PK parameters were determined using the following blood sampling times: pre-dose (within 10 minutes of ketorolac tromethamine administration), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 h post administration of study drug on Days 1 and 6|The half-life could not be estimated for a subject due to the nature of the subject's PK profile.||hours||Standard Deviation|Mean
697496|NCT01365611|Primary|AUC Inf (the AUC From Time Zero to Infinity, Where Possible)||PK parameters were determined using the following blood sampling times: pre-dose (within 10 minutes of ketorolac tromethamine administration), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 h post administration of study drug on Days 1 and 6|The half-life could not be estimated for a subject due to the nature of the subject's PK profile.||ng*hours/mL||Standard Deviation|Mean
697498|NCT01365611|Primary|Tmax (the Time to Maximum Concentration of Ketorolac Tromethamine)||PK parameters were determined using the following blood sampling times: pre-dose (within 10 minutes of ketorolac tromethamine administration), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 h post administration of study drug on Days 1 and 6|||hours||Full Range|Median
697500|NCT01365585|Secondary|Change From Baseline in Borg Dyspnea Index at Year 1, 2, 3 and 4|Borg dyspnea scale: 10-point scale where following scores stands for severity of dyspnea: 0=no breathlessness at all;0.5=very very slight (just noticeable); 1=very slight; 2=slight breathlessness; 3=moderate; 4=some what severe; 5=severe; 7=very severe breathlessness; 9=very very severe (almost maximum) and 10=maximum.|Baseline, Year 1, 2, 3, 4|Analysis population included all participants who satisfied the eligibility criteria for the study. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time points.||units on a scale||Standard Deviation|Mean
697501|NCT01365585|Secondary|Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at Year 1, 2, 3 and 4|PCWP was measured by pulmonary artery catheterization and provided an indirect measure of left atrial pressure.|Baseline, Year 1, 2, 3, 4|Data was not summarized because results were available for very few participants and were insufficient for analysis.|||||
697502|NCT01365585|Secondary|Change From Baseline in Cardiac Index (CI) at Year 1, 2, 3 and 4|CI: calculated as COsys divided by BSA.|Baseline, Year 1, 2, 3, 4|Data was not summarized because results were available for very few participants and were insufficient for analysis.|||||
697503|NCT01365585|Secondary|Change From Baseline in Pulmonary Vascular Resistance (PVR) at Year 1, 2, 3 and 4|PVR: calculated by subtracting PCWP from mPAP and dividing by cardiac output in pulmonary circulation (COpulm).|Baseline, Year 1, 2, 3, 4|Data was not summarized because results were available for very few participants and were insufficient for analysis.|||||
697504|NCT01365585|Secondary|Change From Baseline in Mean Pulmonary Arterial Pressure (mPAP) at Rest at Year 1, 2, 3 and 4|mPAP was measured using a pressure transducer positioned at the mid-axillary line with the participant in the supine position.|Baseline, Year 1, 2, 3, 4|Data was not summarized because results were available for very few participants and were insufficient for analysis.|||||
697505|NCT01365585|Secondary|Change From Baseline in Right Atrial Pressure (RAP) at Year 1, 2, 3 and 4|RAP was measured using a pressure transducer positioned at the mid-axillary line with the participant in the supine position.|Baseline, Year 1, 2, 3, 4|Data was not summarized because results were available for very few participants and were insufficient for analysis.|||||
697506|NCT01365585|Secondary|Change From Baseline in New York Heart Association, World Health Organization (NYHA/WHO) Functional Class in Participants With Pulmonary Arterial Hypertension (PAH) at Year 1, 2, 3 and 4|NYHA/WHO functional classification for PAH range from Class I (no limitation in physical activity, no dyspnea with normal activity) to Class IV (can not perform a physical activity without any symptoms, dyspnea at rest). Improvement=reduction in functional class, deterioration = increase in functional class, no change = no change in functional class. Number of participants in each functional class was reported.|Baseline, Year 1, 2, 3, 4|Analysis population included all participants who satisfied the eligibility criteria for the study. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure. Here, 'n' included those participants who were evaluable for this measure at specified time points.||participants|||Number
697507|NCT01365585|Primary|Change From Baseline in 6-Minute Walk Distance (6MWD) at Year 4|6MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed.|Baseline, Year 4|Analysis population included all participants who satisfied the eligibility criteria for the study. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure.||meter||Standard Deviation|Mean
697508|NCT01365585|Primary|Change From Baseline in 6-Minute Walk Distance (6MWD) at Year 3|6MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed.|Baseline, Year 3|Analysis population included all participants who satisfied the eligibility criteria for the study. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure.||meter||Standard Deviation|Mean
697509|NCT01365585|Primary|Change From Baseline in 6-Minute Walk Distance (6MWD) at Year 2|6MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed.|Baseline, Year 2|Analysis population included all participants who satisfied the eligibility criteria for the study. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure.||meter||Standard Deviation|Mean
697510|NCT01365585|Primary|Change From Baseline in 6-Minute Walk Distance (6MWD) at Year 1|6MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed.|Baseline, Year 1|Analysis population included all participants who satisfied the eligibility criteria for the study. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure.||meter||Standard Deviation|Mean
697511|NCT01365546|Secondary|Post-operative Efficacy Assessment|Post-operative efficacy was assessed by the investigator, covering the time period from the end of the procedure up to 24 hours following the last infusion of study medication. This assessment took the post-operative bleeding and oozing into consideration|up to 30 days|||participants|||Number
697512|NCT01365546|Secondary|Assessment of Intra-operative Hemostatic Efficacy|The efficacy of Wilate during surgical procedures was assessed by a 4-point ordinal efficacy scale by the surgeon at the end of the surgical procedure and took the predicted versus actual blood loss and transfusion requirements into consideration. Outcome measure 1 takes the results of outcome measure 2 and 3 into consideration and is an overall assessment covering intra- and post-operative efficacy.|1 Day|||participants|||Number
697513|NCT01365546|Primary|Overall Hemostatic Efficacy (Success or Failure) of Wilate, Based on the Intra-operative Assessment of the Surgeon and the Post-operative Assessment by the Investigator Using a 4-point Ordinal Efficacy Scale.|Efficacy of Wilate in surgical procedures was assessed intra-operatively by the surgeon and post-operatively by the investigator. The IDMC additionally conducted an independent adjudication of all hemostatic efficacy results (‘secondary adjudication’) and adjudicated the surgeons’/investigators’ assessments of the intra- and post-operative assessments where there were discrepancies between the two assessments (‘primary adjudication’). It was specified in the SAP that the study will be terminated early and success claimed if the two-sided 98.75% confidence interval (CI) for the overall success rate excludes and is greater than 0.60 (equivalent to 25 or more successes out of the 30 procedures).|30 Days|||participants||95% Confidence Interval|Number
697514|NCT01365507|Secondary|Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of nocturnal confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 a.m.|Week 0 to Week 26 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product.||Episodes/100 years of patient exposure|||Number
697515|NCT01365507|Secondary|Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 26 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product.||Episodes/100 years of patient exposure|||Number
697516|NCT01365507|Secondary|Rate of Treatment Emergent Adverse Events (AEs)|Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.|Week 0 to Week 26 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product.||Events/100 years of patient exposure|||Number
697517|NCT01365507|Secondary|Change in Fasting Plasma Glucose (FPG)|Change from baseline in FPG after 26 weeks of treatment.|Week 0, week 26|The full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). For 2 subjects baseline values were missing, hence not included in the analysis.||mmol/L||Standard Deviation|Mean
697518|NCT01365507|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Change from baseline in HbA1c after 26 weeks of treatment.|Week 0, week 26|The full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF).||percentage of glycosylated haemoglobin||Standard Deviation|Mean
697519|NCT01365494|Secondary|Percentages of Subjects Reporting Adverse Events (AEs)|Adverse events (AEs) were collected for 7 days following administration of each study vaccination or until time of next vaccination (whichever occurred sooner). All reported SAEs and medically attended AEs or AEs that resulted in the premature withdrawal of subjects during the study were collected throughout the study period and all AEs were unsolicited.|All reported SAEs and medically attended AEs or AEs that resulted in the premature withdrawal of subjects were collected up to 42 days after first vaccination. Adverse events were collected throughout the study period|Safety population- All subjects in the Exposed population who provide post vaccination safety data and as vaccinated (as treated)||percentages of subjects|||Number
697520|NCT01365494|Secondary|Ratio of GMCs in Study Groups (Zagreb/Essen Schedules) on Days 7 and 42 as Measured by RVNA Geometric Mean Concentrations|Immunogenicity was measured as the ratio of GMCs of RVNA titer , evaluated using the rapid fluorescent focus inhibition test, on Days 7 and 42 as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedules|Day 0, Day 7, Day 14 and Day 42|Full Analysis Set- All subjects in the exposed population who provided at least one evaluable serum sample and as randomized||IU\ml||95% Confidence Interval|Geometric Mean
697521|NCT01365494|Secondary|Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Zagreb and Essen Groups at Days 7, 14 and 42|Immunogenicity was measured as the percentage of subjects who achieved anti-RVNA titer ≥0.5 IU/mL, at days 0, 7, 14 and 42 as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.|Study day 7, 14 and 42|Full Analysis Set- All subjects in the exposed population who provided at least one evaluable serum sample and as randomized||Percentages of Subjects|||Number
697522|NCT01365494|Primary|Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration in Each of the Zagreb and Essen Groups on Study Day 14|Immunogenicity was measured as the geometric mean concentrations (GMCs) of rabies virus neutralizing antibody (RVNA) titer , evaluated using the rapid fluorescent focus inhibition test, before vaccination and on study day 14 as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule|On Day 0 and Day 14|Per Protocol Set-All subjects in the FAS (Full analysis set) population who:correctly receive the vaccine, provide evaluable serum sample at day 14, and have no major protocol violation as defined prior to analysis||IU/mL||95% Confidence Interval|Geometric Mean
697523|NCT01365481|Secondary|Percentage of Chronic Kidney Disease (CKD) Patients Who Had Estimated Glomerular Filtration Rate (eGFR) Decrease > 25 % From Baselinefrom Baseline to End Point|Percentage of Patients with CKD who had eGFR decrease > 25 % from Baseline|Baseline, End Point (Week 78 or Last observation carried forward (LOCF)|The Safety set (SAF) included all patients who received at least one dose of study medication.that has Chronic Kidney Disease (CKD)||Percentage of patients|||Number
697524|NCT01365481|Primary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (MsDBP) at End Point (Week 78 or Last Observation Carried Forward (LOCF)|Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 2 to 3 minute intervals and the mean of three sDBP measurements were used as the average sitting office blood pressure for that visit.|Baseline, End Point (Week 78 or Last observation carried forward (LOCF)|The Full Analysis set (FAS) included all patients who entered the treatment period. ) This OM looked at the Valsartan + Antihypertensive and Valsartan alone for ALL patients and did not break up the analysis between CKD and non-CKD patients.||millimeter(s) of mercury (mmHg)||Standard Deviation|Mean
697525|NCT01365481|Secondary|Percentage of Chronic Kidney Disease (CKD) Patients Who Had >=50% Reduction in Urine Albumin/Creatinine Ratio (UACR) From Baseline to End Point|Percentage of Patients with CKD who had Urine albumin creatinine reduction >/= 50% from baseline|Baseline, End Point (Week 78 or Last observation carried forward (LOCF)|The Safety set (SAF) included all patients who received at least one dose of study medication that has Chronic Kidney Disease (CKD) only||Percentage of patients|||Number
697526|NCT01365481|Secondary|Number of Participants With MSSBP, MSDBP and (MSSBP and MSDBP Combined) < 95th Percentile for Gender, Age, and Height|Number of Participants with Mean sitting systolic (MSSBP) and mean sitting diastolic(MSDBP) blood pressure and both combined less than the 95th percentile for age, gender and height|End Point (Week 78 or Last observation carried forward (LOCF)|The Full Analysis set (FAS) included all patients who entered the treatment period. This analysis includes only participants with baseline MSSBP or MSDBP or (MSSBP or MSDBP combined) ≥95th percentile for gender, age and height. n analyzed is displayed in left column. This OM did not break up the analysis between CKD and non-CKD patients.||Number of Participants|||Number
697527|NCT01365481|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at End Point (Week 78 or Last Observation Carried Forward (LOCF)|Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 2 to 3 minute intervals and the mean of three sSBP measurements were used as the average sitting office blood pressure for that visit.|Baseline, End Point (Week 78 or Last observation carried forward (LOCF)|The Full Analysis set (FAS) included all patients who entered the treatment period. ) This OM looked at the Valsartan + Antihypertensive and Valsartan alone for ALL patients and did not break up the analysis between CKD and non-CKD patients.||millimeter(s) of mercury (mmHg)||Standard Deviation|Mean
697528|NCT01365468|Other Pre-specified|Physician’s Global Assessment of Clinical Condition (PGA) of Skin Lesions|The Physician‟s Global Assessment of Clinical Condition (PGA) is a 7-point grading scale for the investigator's assessment of the overall extent of improvement or worsening of the patient‟s skin disease as compared to baseline. Responses must be confirmed by at least two assessments separated in time by at least 4 weeks. The grading ranges from 0 to 6; 0 is Completely clear where as 6 is for worse condition. A complete clinical response (CCR) requires a grading of 0 indicating the absence of disease (histological confirmation is not required). Grades 1, 2, and 3 constitute partial response, indicating improvement of at least 50 percent, but less than 100 percent improvement.|Screening, after course #3, #6, #12, #18, #24, End of Treatment (1 course = 28 days)|Study got terminated because of poor patient's accrual. Enrolled patients were less than planned number of patients required for analysis. Hence, planned analysis was not done.|||||
697529|NCT01365468|Other Pre-specified|Number of Patients With Clinical Response|Clinical response is defined as improvement of function, performance status, or decrease in PN related pain persisting for at least 28 days on treatment.|Screening, Day 1, after course #3, #6, #12, #18, #24, End of Treatment (1 course = 28 days)|Study got terminated because of poor patient's accrual. Enrolled patients were less than planned number of patients required for analysis. Hence, planned analysis was not done.|||||
697530|NCT01365468|Primary|Number of Patients With Adverse Events Assessed by Common Toxicity Criteria for Adverse Events (CTCAE) V.04|Adverse events were assessed according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0. If CTCAE grading does not exist for an adverse event, the severity of mild, moderate, severe, and life-threatening, corresponding to grades 1 - 4 respectively, were used. CTCAE grade 5 (death) was not used in this study.|From the time ICF was signed until 28 days after End of Treatment (up to a maximum of 25 months)|The Safety Population consisted of all patients who received at least one dose of study treatment and had at least one post-baseline safety assessment.||Patients|||Number
697531|NCT01365468|Primary|Number of Patients With Objective Radiographic Responses Based on Volumetric MRI Measurements (In Stratum 2 Only)|"Response was assessed at the time that a follow up volumetric MRI scan is performed (after course 6 and then every 6 months and at the end of treatment).
Complete response (CR): complete resolution of all measurable or palpable PN for ≥ 28days and no appearance of new lesions.
Partial response (PR): A ≥ 20% reduction in the sum of the volume of all index PN lesions for ≥ 28days.
Stable disease (SD): A ‹ 20% increase and ‹ 20% decrease in the sum of the volume of all index PN lesions for ≥ 28days."|Screening, after course #6, then every 6 months and end of treatment(1 course=28days)|The Full Analysis Set (FAS) consisted of all enrolled patients.||Patients|||Number
697532|NCT01365468|Primary|Time to Disease Progression (TTP) Based on Change in Volumetric MRI Measurements in Children and Adults (In Stratum I Only)|This endpoint was planned to be analyzed for only Stratum 1 patients. Progression of disease defined as a ≥ 20% increase in the volume (by volumetric MRI) of at least one of the index plexiform neurofibromas (PN) compared to the pretreatment volume measured prior to the start of the current treatment phase.|Screening, after course #6, #12, #18, #24, End of Treatment(1 course=28days)|The Full Analysis Set (FAS) consisted of all enrolled patients.||Days||95% Confidence Interval|Median
697533|NCT01365455|Secondary|Number of Participants Who Developed Anti-secukinumab Antibodies|The development of anti-secunimubab anti-bodies would decrease a participant’s ability to respond to secukinumab treatment.|Week 12|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.||participants|||Number
697534|NCT01365455|Secondary|Percentage of Participants Achieving PASI 75, PASI 90 and IGA Mod 2011 0 or 1 Response at Week 12 by Previous Exposure to Biologic Systemic Therapy or Anti-TNF-α Therapy and Failed to Respond to a Previous Biologic or Anti-TNF-α Therapy Psoriasis Therapy|PASI is an assessment of lesion severity & affected area into a single score:0(no disease)to 72(max. disease).Body is divided into 4 areas for scoring(head,arms,trunk,legs)each area is scored separately & then added for final PASI.For each area, % of skin involved is estimated:0(0%)to 6(90-100%)& severity is estimated by clinical signs, erythema,induration & desquamation;scale 0(none) to 4(max). Final PASI=sum of severity parameters for each area* area score weight of section(head:0.1,arms:0.2 body:0.3 legs:0.4).PASI 75, 90 is patients achieving≥75%or90% improvement from baseline.The IGA mod 2011 scale is static, exclusively to the patients disease at assessment,& not with any of the patient's previous disease states at other visits.The scores are:0=clear,1=almost clear,2= mild,3=moderate&4=severe.Response variables PASI 75,90, IGA mod 2011 0 or 1 response at wk 12 was scored versus previous psoriasis systemic therapy & response to previous biologic systemic therapy by treatment|Week 12|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.||Percentage of participants|||Number
697535|NCT01365455|Secondary|Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) of 0 or 1 During Maintenance Period|"The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). Not relevant is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative mean percentage change from baseline indicates improvement."|Week 12,24,36, & 52|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.||Percentage of Participants|||Number
697536|NCT01365455|Secondary|Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) of 0 or 1 During Induction Period|"The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). Not relevant is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative mean percentage change from baseline indicates improvement."|Week 4, 8, 12|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.||Percentage of Participants|||Number
697537|NCT01365455|Secondary|Percentage Changes in the Dermatology Life Quality Index (DLQI) During Maintenance Period|"The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). Not relevant is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative mean percentage change from baseline indicates improvement."|Week 12,24, 36 & 52|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.||Percent Change||95% Confidence Interval|Median
697538|NCT01365455|Secondary|Percentage Changes in the Dermatology Life Quality Index (DLQI) During Induction Period|"The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). Not relevant is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative mean percentage change from baseline indicates improvement."|Baseline, Week 4, 8 & 12|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.||Percent Change||95% Confidence Interval|Median
697539|NCT01365455|Secondary|Mean Percent Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment (From 0 to 100) Maintenance Period|The EQ-5D is an instrument used to assess a participant's health status. The instrument includes a descriptive profile and a visual analog scale (VAS). The descriptive profile includes 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension had 3 response levels: no problems, some problems and severe problems. The VAS is a vertical scale that assesses the health status from 0 (worst possible health state) to 100 (best possible health state). This outcome measures the percent change in VAS score. Positive mean percent changes indicate improvement.|Week 12, 24, 36, 52|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.||Percent Change||Standard Deviation|Mean
697540|NCT01365455|Secondary|Mean Percent Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment (From 0 to 100) Induction Period|The EQ-5D is an instrument used to assess a participant's health status. The instrument includes a descriptive profile and a visual analog scale (VAS). The descriptive profile includes 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension had 3 response levels: no problems, some problems and severe problems. The VAS is a vertical scale that assesses the health status from 0 (worst possible health state) to 100 (best possible health state). This outcome measures the percent change in VAS score. Positive mean percent changes indicate improvement.|Baseline, Week 4,8, 12|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.||percent change||Standard Deviation|Mean
697969|NCT01361854|Primary|Failure Rate of Sleep Study|"failure rate of polysomnography according to the hook-up protocol. Polysomnographies scored as poor or unsatisafctory according to Redline et al. SLEEP 1998 are considered as failed."|1 day|||percentage of participants|||Number
697541|NCT01365455|Secondary|Time to PASI 75 Response up to 12 Weeks|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (max). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 75 was defined as participants achieving ≥ 75% improvement from baseline.|Week 12|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.||days||Inter-Quartile Range|Median
697542|NCT01365455|Secondary|Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52|The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.|Week 13,14,15,16,20,24,28,32,36,40,44,48,52|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.||Percentage of participants|||Number
697543|NCT01365455|Secondary|Percentage of Participants in Each IGA Mod 2011 Score Category up to Week 12 - Induction Period|The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.|Baseline, Week 1,2,3,4,8,12,|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.||Percentage of participants|||Number
697544|NCT01365455|Secondary|Mean Percent Change From Baseline in PASI Scores Maintenance Period After Week 12 to Week 52|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). A negative mean percentage change indicates improvement.|Week 13,14,15,16,20,24,28,32,36,40,44,48,52|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.||Percent change||Standard Deviation|Mean
697545|NCT01365455|Secondary|Mean Percent Change From Baseline in PASI Scores up to Week 12 - Induction Period|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). A negative mean percentage change indicates improvement.|Baseline, Week 1,2,3,4,8,12,|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.||Percent Change||Standard Deviation|Mean
697546|NCT01365455|Secondary|Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (max). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.|Week 13,14,15,16,20,24,28,32,36,40,44,48,52|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.||Percentage of participants|||Number
697571|NCT01364922|Secondary|Participant’s Global Assessment of Back Pain Status at Final Evaluation|"The participant’s overall impression of their back pain status was obtained by having the participant answer the question Considering all the ways your chronic low back pain affects you, how are you doing today? on a 5-point categorical scale: very good (no symptoms and no limitation of normal activities); good (mild symptoms and no limitation of normal activities); fair (moderate symptoms and limitation of some normal activities); poor (severe symptoms and inability to carry out most normal activities); very poor (very severe symptoms which are intolerable and inability to carry out all normal activities)."|Double-blind baseline to Day 29|||participants|||Number
697970|NCT01361633|Secondary|Implicit Memory Task|Assesses implicit memory for anxious and neutral words|Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up||||||
697547|NCT01365455|Secondary|Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response up to 12 Weeks Induction Period|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (max). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.|Week 1,2,3,4,8,12,|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.||Percentage of participants|||Number
697548|NCT01365455|Secondary|Change From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Placebo|The Psoriasis Symptom Diary©, a 16-item patient reported outcome (PRO) measure developed and validated in accordance with the FDA PRO Guidance (FDA Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims, 2009), demonstrated favorable psychometric properties and usefulness for treatment efficacy evaluation alongside other measures of disease severity in clinical trials for chronic plaque psoriasis.Weekly averages will be derived for each of the 16 questions of the Psoriasis Diary up to Week 12. A weekly average is the sum of the scored item over the course of the study week divided by the number of days on which the item was completed and will be set to missing if four or more daily assessments were missing of the corresponding question. A reduction in score from baseline shows efficacy. Each question has a score of 0 (no symptoms) up to 10 (Severe symptoms)|Week 12|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.||Scores on a Scale||Standard Error|Mean
697549|NCT01365455|Secondary|Number of Participants That Maintained the IGA Mod 2011 0 or 1 Response at 52 Weeks of Treatment for Participants Who Were IGA Mod 2011 0 or 1 Responders at Week 12|The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. Treatment success was defined as achievement of IGA mod 2001 score of 0 or 1.|12 and 52 weeks|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.||number of participants|||Number
697550|NCT01365455|Secondary|Number of Participants That Maintained the Psoriasis Area and Severity Index (PASI) 75 Response at 52 Weeks of Treatment for Participants Who Were PASI 75 Responders at Week 12|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).|12 and 52 weeks|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.||number of participants|||Number
697551|NCT01365455|Secondary|Percentage of Participants Who Achieved a PASI (Psoriasis Area and Severity Index) Score of 90 or Better at Week 12|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 90 was defined as participants who achievied ≥ 90% improvement from baseline.|12 weeks|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.||Percentage of Participants|||Number
697552|NCT01365455|Primary|Percentage of Participants Who Achieved (Investigator's Global Assessment) IGA Score of 0 or 1|The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. Treatment success was defined as achievement of IGA mod 2001 score of 0 or 1. IGA score of 0 or 1 as an indicator of efficacy.|12 weeks|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.||Percentage of Participants|||Number
697624|NCT01363908|Secondary|Change From Baseline in Cardiac Iron Load Assessed by T2* MRI|The efficacy of SPD602 was assessed by determining cardiac iron load. Cardiac MRI data were collected by using T2* standard procedures and used to determine iron load. A negative change from baseline indicates that iron load increased.|Baseline, 24 weeks, and 48 weeks|The FAS, defined as all participants in the Safety Analysis Set who had at least 1 post-baseline primary efficacy assessment, which was considered as the LICs assessed from FerriScan R2 MRI.||milliseconds||Standard Deviation|Mean
697553|NCT01365455|Primary|Percentage of Participants Who Achieved >75 or Higher (Psoriasis Area and Severity Index) PASI Score at 12 Weeks|A 75% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 75) is the current benchmark of primary endpoints for most clinical trials of psoriasis. PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).|12 weeks|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.||Percentage of participants|||Number
697554|NCT01365273|Primary|VAS Score for Pain After Dressing Removal|"Pain after the dressing removal measued with Visual Analogue Scale (VAS).0 = no pain till 100 = worst pain."|Visit 6, day 7|All subjects to post-randomization treatment and that provided some data for the primary endpoint were included in the ITT analysis.||units on a scale||Standard Deviation|Median
697555|NCT01365273|Primary|VAS Score for Pain During Dressing Removal|"Pain when half of the study product(s) has been removed measued with Visual Analogue Scale (VAS).0 = no pain till 100 = worst pain."|Visit 6, day 7|All included subjects to post-randomization treatment and that provided some data for the primary endpoint was included in the Intention To Treat analyses.||units on a scale||Standard Deviation|Median
697556|NCT01365273|Primary|VAS Score for Pain Before Dressing Removal|"Pain was measured with Visual Analogue Scale (VAS)(100 mm) measuring from 0 = no pain at one end to 100 = most intense pain imagaginable at the other end."|At visit 6, day 7|All subjects to post-randomization treatment and that provided some data for the primary endpoint were included in the ITT analysis.||units on a scale||Standard Deviation|Median
697557|NCT01365130|Secondary|To Assess the Toxicity Associated With Cabazitaxel for Patients With Metastatic Gastroesophageal Adenocarcinomas That Have Progressed After at Least One Line of Therapy for Metastatic Disease.|We will look at the number of patients who have Hematologic Toxicity as well as non-hematologic toxicity|at approx 6, 12 and 18 months||||||
697558|NCT01365130|Primary|Number of Patients Without Progression at 3 Months|Response will be assessed via RECIST 1.1 criteria|every three cycles approx every 63 days|||participants|||Number
697559|NCT01365091|Primary|AUC From Time 0 Extrapolated to Infinite Time (AUC[0-inf]) for Metformin, Saxagliptin, and 5-Hydroxy (5-OH) Saxagliptin as a Fixed-dose Combination (FDC) and as Individual Tablets|AUC=Area Under the Concentration-time Curve|Days 1, 2, and 3 of Periods 1 and 2|Participants who received study medication and were evaluable||ng*h/mL||Standard Deviation|Mean
697560|NCT01365091|Secondary|Number of Participants With Death as Outcome and Serious Adverse Events (SAEs)|SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|Continuously, from screening through Day 1 to within 30 days of drug discontinuation on Day 1|All enrolled participants who receive study medication||Participants|||Number
697561|NCT01365091|Primary|AUC From Time 0 to Time of the Last Quantifiable Concentration (AUC[0-T])of Metformin, Saxagliptin, and 5-Hydroxy (5-OH) Saxagliptin as a Fixed-dose Combination (FDC) and as Individual Tablets|AUC=Area under the concentration-time curve|Days 1, 2, and 3 of Periods 1 and 2|Participants who received study medication and were evaluable||pg*h/mL||Standard Deviation|Mean
697562|NCT01365091|Primary|Maximum Observed Concentrations (Cmax) of Metformin, Saxagliptin, and 5-Hydroxy (5-OH) Saxagliptin as a Fixed-dose Combination (FDC) and as Individual Tablets||Days 1, 2, and 3 of Periods 1 and 2|Participants who received study medication and were evaluable||μg/mL||Standard Deviation|Mean
697563|NCT01365052|Other Pre-specified|Treatment Compliance - Duration of Exposure to Treatment in Days||10 days after randomization|Safety population||Days||Standard Deviation|Mean
697564|NCT01365052|Other Pre-specified|Treatment Compliance - Number of Capsules Taken||10 days after randomization|Safety population||Capsules||Standard Deviation|Mean
697565|NCT01365052|Primary|Percentage of Subjects With Any Serious Adverse Event for Those Subjects Who Were Randomized and Took at Least One Dose of Investigational Product|Please see further details in AE section|10 days after randomization|Safety population||Percentage of participants|||Number
697566|NCT01365052|Primary|Percentage of Subjects With Any Adverse Event for Those Subjects Who Were Randomized and Took at Least One Dose of Investigational Product|Please see further details in Adverse Events (AE) section|10 days after randomization|Safety population||Percentage of participants|||Number
697567|NCT01365052|Other Pre-specified|Percentage of Subjects Who Discontinued Due to an Adverse Event for Those Subjects Who Are Randomized and Take at Least One Dose of Investigational Product||10 days after randomization|Safety population||Percentage of participants|||Number
697568|NCT01365039|Primary|High Contrast, Distance logMAR Visual Acuity (VA)|Mean high contrast, distance logMAR VA for each eye between the Test and Control lenses. For each eye, logMAR VA will be averaged over all follow-up visits as the primary endpoint|4 visits over 3 months|All Eligible, Dispensed Eyes||logMAR|Participants|Standard Deviation|Mean
697569|NCT01365039|Primary|Slit Lamp Findings > Grade 2|Statistical non-inferiority of Slit Lamp Findings > Grade 2 at any visit between the Test and Control lenses|4 visits over 3 months|Over All Follow-up Visits, Eyes with Findings > Grade 2 (All Dispensed Eyes)||eyes|Participants||Number
697570|NCT01364922|Secondary|Participant’s Global Assessment of Study Drug at Final Evaluation|"The participant’s overall impression of the study drug was obtained by having the participant answer the question How would you rate your overall response to the study medication? on a 5-point categorical scale: excellent; very good; good; fair; poor."|Double-blind baseline to Day 29|Double-blind intent to treat population; scores for participants with no post-randomization assessment were excluded from this analysis.||participants|||Number
697971|NCT01361633|Secondary|Stroop|Assesses executive functioning|Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up||||||
697572|NCT01364922|Primary|Change From Double-blind Baseline in Chronic Lower Back Pain (CLBP) Intensity by Visual Analog Scale (VAS)|The change from the double-blind randomization baseline (DB baseline: the last assessment before first dose in the double-blind period) to the final assessment in pain intensity, assessed using the CLBP Intensity VAS (0 mm = No Pain and 100 mm = Worst Pain Imaginable). Least squares means and standard errors from an ANCOVA model.|Double-blind baseline to Day 29|The analysis of the primary outcome measure included all randomized participants who received at least 1 dose of study drug during the double-blind period (double-blind intent-to-treat) and had at least 1 assessment during the double-blind period.||scores on a scale||Standard Error|Least Squares Mean
697573|NCT01364896|Primary|Number of Participants With High-grade Anal Dysplasia Lesions|High resolution anoscopy and biopsy of all visible high-grade dysplastic lesions based on validated colposcopic criteria|Baseline and 6 to 12 months|||participants|||Number
697574|NCT01364896|Primary|Number of Participants Who Had One or More Anal Biopsies|High resolution anoscopy and biopsy of all visible high-grade dysplastic lesions based on validated colposcopic criteria|Baseline and 6 to 12 months|||participants|||Number
697575|NCT01364896|Primary|Number of Participants With Abnormal Anal Cytology (ASC-US, ASC-H, LSIL, HSIL, Cancer)|High-resolution anoscopy with anal cytology testing|Baseline and 6 to 12 months|||participants|||Number
697576|NCT01364896|Primary|Percent of Participants With HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and/or 58||Baseline and 6 to 12 months|||percentage of participants|||Number
697577|NCT01364896|Primary|Number of Participants With Anal HPV of Any Type, Single Type, and Multiple Types|Anal (and vaginal for female participants) HPV PCR typing (6, 11, 16, 18, 31, 33, 45, 52, 58) using the SYBR-Green-based real-time PCR assay with a reverse line blot assay for genotyping of HPV in the positive samples and Taqman probe-based real-time PCR assays for quantification of individual HPV subtypes|Baseline and 6 to 12 months|||participants|||Number
697578|NCT01364740|Other Pre-specified|Attitude Toward Device Use Questionnaire Scores|Questionnaire consisting of multiple questions, scored as 1 = disagree completely to 5 = agree completely, revealed the following mean scores|one night|||units on a scale||Standard Deviation|Mean
697579|NCT01364740|Secondary|Oxygen Saturation|Mean oxygen saturation|One night|||percent||Standard Deviation|Mean
697580|NCT01364740|Secondary|Hypopnea Index|Number of events/hour of sleep. Hypopneas scored without EEG arousals.|One night|||events/hour||Standard Deviation|Mean
697581|NCT01364740|Secondary|Apnea Index|Number of events/hour of sleep|One night|||events/hour||Standard Deviation|Mean
697582|NCT01364740|Primary|AHI|Apnea-Hypopnea Index (number of events/hour of sleep). Hypopneas scored without EEG arousals.|One night|||events/hour||Standard Deviation|Mean
697583|NCT01364727|Secondary|Disease Control Rate (DCR)|"Disease control rate (DCR) is the sum of Complete Response (CR) rate + Partial Response (PR) rate + Stable Disease (SD) rate , and is expressed here as the sum of the Overall Response Rate (ORR = CR + PR) plus the Stable Disease (SD) rate, ORR + SD.
Response was assessed by the RECIST criteria, elaborated above."|2 years|Includes those participants with Complete Response (CR) plus those with Partial Response (PR), plus those with Stable Disease).||Participants|||Count of Participants
697584|NCT01364727|Secondary|Median Progression-free Survival (PFS)|Median Progression-free survival in patients with thymic malignancies treated with amrubicin|2 years|Some participants (2) continue to survive without progression, although a median and the 95% confidence interval (95% CI) for the 33 participants have been defined.||Months||95% Confidence Interval|Median
697585|NCT01364727|Primary|Overall Response Rate (ORR)|"Participants received amrubicin 35 mg/m2 IV days 1 to 3, every 3 weeks, until progression or toxicity.
Tumor response rate was assessed radiographically by the Response Evaluation Criteria In Solid Tumors (RECIST), and the overall response rate (ORR) was expressed as the sum of the Complete Response (CR) rate and the Partial Response (PR) rate.
RECIST criteria define when cancer patients improve (respond); stay the same (stable); or worsen (progression) during treatments. The criteria presume that linear measures are an adequate substitute for 2-dimensional (2D) methods and includes 4 response categories:
CR = Disappearance of all target lesions
PR = 30% decrease in the sum of the longest diameter of target lesions
Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions
Stable disease (SD) = Small changes that do not meet above criteria"|2 years|Includes those participants with Complete Response (CR) plus those with Partial Response (PR).||Participants|||Count of Participants
697586|NCT01364649|Secondary|Number of Participants With Shifts in the CSFQ-14 From Abnormal to Normal at Each Week Assessed|The CSFQ-14 is a structured self reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), and orgasm (3 items), rated on an 5 point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning. Normal sexual functioning is defined as a CSFQ-14 total score of >41 for women and >47 for men. Abnormal sexual functioning is defined as a CSFQ-14 total score of ≤41 for women and ≤47 for men. All subjects entered the study with abnormal sexual functioning. A shift to normal indicates that symptoms have improved.|Baseline and Weeks 1, 2, 4, 6 and 8|Participants from the FAS, defined as all participants who were randomized and received at least 1 dose of study drug, who had data available for this outcome measure. Last observation carried forward.||number of participants|||Number
697587|NCT01364649|Secondary|Change From Baseline in the CSFQ-14 Total Score at All Other Time Points Assessed|The CSFQ-14 is a structured self reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), and orgasm (3 items), rated on an 5 point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning. A positive change from Baseline indicates that symptoms have improved. The primary analysis was based on a mixed model for repeated measurements (MMRM) analysis of covariance with treatment, center, week, treatment-by-week interaction as fixed effects, Baseline CSFQ-14 total score-by-week as covariate, and a completely unstructured covariance matrix.|Baseline and Weeks 1, 2, 4 and 6|Participants from the FAS, defined as all participants who were randomized and received at least 1 dose of study drug, who had data available for this outcome measure.||scores on a scale||Standard Error|Least Squares Mean
697588|NCT01364649|Primary|Change From Baseline in the Changes in Sexual Functioning Questionnaire Short-Form (CSFQ-14) Total Score at Week 8|The CSFQ-14 is a structured self reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), and orgasm (3 items), rated on an 5 point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning. A positive change from Baseline indicates that symptoms have improved. The primary analysis was based on a mixed model for repeated measurements (MMRM) analysis of covariance with treatment, center, week, treatment-by-week interaction as fixed effects, Baseline CSFQ-14 total score-by-week as covariate, and a completely unstructured covariance matrix.|Baseline, Week 8|Participants from the Full Analysis Set (FAS), defined as all participants who were randomized and received at least 1 dose of study drug, who had data available for this outcome measure.||scores on a scale||Standard Error|Least Squares Mean
697589|NCT01364558|Primary|Comparison of the Absolute Bioavailability of Two Intranasal Diazepam Formulations.|"To calculate bioavailability we used the following formula:
Area Under the Curve (Intranasal Spray)*100/Area Under the Curve (Intravenous Injection)"|2 days|||Percentage of Bioavailability||90% Confidence Interval|Geometric Mean
697590|NCT01364428|Secondary|Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 a.m.|Week 0 to Week 22 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||Episodes/100 years of patient exposure|||Number
697591|NCT01364428|Secondary|Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 22 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||Episodes/100 years of patient exposure|||Number
697592|NCT01364428|Secondary|Rate of Treatment Emergent Adverse Events (AEs)|Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.|Week 0 to Week 22 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||Events/100 years of patient exposure|||Number
697593|NCT01364428|Secondary|Change in Fasting Plasma Glucose (FPG)|Change from baseline in FPG after 22 weeks of treatment.|Week 0, Week 22|The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF). For 5 subjects baseline values were missing.||mmol/L||Standard Deviation|Mean
697594|NCT01364428|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Change from baseline in HbA1c after 22 weeks of treatment|Week 0, Week 22|The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF).||percentage of glycosylated haemoglobin||Standard Deviation|Mean
697595|NCT01364389|Secondary|Effect on Health-related Quality of Life||6 months||||||
697596|NCT01364389|Secondary|Comparison Between the Initial Response to AIN457 and ACZ885 and the Response After Re-dosing of AIN457 and ACZ885||6 months||||||
697597|NCT01364389|Secondary|Pharmacokinetics of AIN457 and ACZ885||Day 15||||||
697598|NCT01364389|Secondary|Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Deaths||6 months|Safety analysis set: This set included all participants who received at least one dose of study medication.||Participants|||Number
697599|NCT01364389|Secondary|Cumulative and/or Mean Steroid Dose Over a 6 Month Period||6 months||||||
697600|NCT01364389|Secondary|Number of Flares Over a 6 Month Period||6 months||||||
697601|NCT01364389|Secondary|Time to First Flare||6 months||||||
697602|NCT01364389|Secondary|Time to Complete Clinical Response|The time to complete clinical response was assessed in patients who received a single dose of AIN457 or ACZ885 (canakinumab). Daily monitoring (home-based) of CRP was performed. This outcome shows the percentage of patients who achieved a complete clinical response at Day 15. A participant was defined as a complete responder if the participant had: >70% reduction in patient global assessment VAS compared with baseline, morning stiffness < 30 min, CRP < 1.0 mg/dL and/or ESR < 30 mm/1st hr.|Day 15|PD analysis set||Percentage of participants|||Number
697603|NCT01364389|Secondary|Time to Partial Clinical Response|"The time to partial clinical response was assessed in patients who received a single dose of AIN457 or ACZ885 (canakinumab). Daily monitoring (home-based) of CRP was performed. This outcome shows the percentage of patients who achieved a partial clinical response at Day 15. A participant was defined as a partial responder if the participant had:
>50% reduction in patient global assessment VAS compared with baseline and morning stiffness < 60 minutes."|Day 15|PD analysis set||Percentage of participants|||Number
697625|NCT01363908|Secondary|Change From Baseline in LIC Adjusted by Transfusional Iron Intake And Assessed by R2* MRI|The efficacy of SPD602 was assessed by determining LIC and adjusting for transfusional iron intake. Abdominal MRI data were collected by using R2* standard procedures and used to determine LIC. A negative change from baseline indicates that LIC decreased.|Baseline, 24 weeks, and 48 weeks|The FAS, defined as all participants in the Safety Analysis Set who had at least 1 post-baseline primary efficacy assessment, which was considered as the LICs assessed from FerriScan R2 MRI.||mg Fe/g*dw||Standard Deviation|Mean
712408|NCT00201123|Primary|Sputum Conversion||Measured at 16 Weeks|Intention to Treat analysis performed. Only subjects excluded were those who did not receive treatment.||percentage of participants|||Number
697604|NCT01364389|Primary|Polymyalgia Rheumatica Activity Score (PMR-AS)|The efficacy of a single dose of AIN457 and ACZ885 (canakinumab) was measured by the polymyalgia rheumatica activity score. A composite PMR-AS was developed from the following components: measure of C-reactive protein (CRP), measure of Erythrocyte Sedimentation Rate (ESR), assessment of early morning stiffness, assessment of the patient’s elevation on upper limbs, patient’s assessment of pain, and physician’s global assessment of disease activity. Treatment effect was measured by the percent reduction in PMR-AS. N=3 for the ACZ885 arm because CRP values at Day 15 were missing for 2 participants.|Baseline, Day 15|Pharmacodynamic (PD) Analysis Set: This set included participants who received at least one dose of study medication and had no major protocol deviation that may impact the PD data.||Percent reduction||Standard Error|Least Squares Mean
697605|NCT01364298|Secondary|Number of Participants With Adverse Events (AEs)|An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.|Day 7 up to Day 84 (+7 days)|Safety population included all the randomized participants who received at least one dose of study drug.||participants|||Number
697606|NCT01364298|Secondary|Percentage of Participants With at Least 30 and 50 Percent (%) Improvement in Numeric Pain Intensity Scale (NPIS) From Baseline at Day 84 (Week 12)|NPIS is a 11-point scale, with 0 representing no pain and 10 representing the worst possible pain. The participants were asked to mark the number that best represents the current level of pain they have experienced during the previous 24 hours.|Baseline and Day 84 (Week 12)|Per protocol population (PPP) included all the treated participants who showed no major protocol violations and were compliant with study inclusion criteria and with the proper administration of the study drug.||percentage of participants|||Number
697607|NCT01364298|Secondary|Number of Participants With Various Health Conditions Based on Clinical Global Impression of Change (CGIC) Scale|CGIC is an assessment that the physician performs to assess the participant’s global change in health condition from start of the study on a 7-point scale (1 = extremely improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse 6 = much worse, 7 = extremely worse).|Baseline and Day 84 (Week 12)|Per protocol population (PPP) included all the treated participants who showed no major protocol violations and were compliant with study inclusion criteria and with the proper administration of the study drug. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.||participants|||Number
697608|NCT01364298|Secondary|Number of Participants With Various Health Conditions Based on Global Impression of Patient Change (GIPC) Scale|GIPC is an assessment that the participant's global change in health condition from start of the study on a 7-point scale (1 = extremely improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse 6 = much worse, 7 = extremely worse).|Baseline and Day 84 (Week 12)|Per protocol population (PPP) included all the treated participants who showed no major protocol violations and were compliant with study inclusion criteria and with the proper administration of the study drug. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.||participants|||Number
697609|NCT01364298|Secondary|Sleep Evaluation: Number of Participants Who Fell Asleep in Pre-specified Time Duration|Sleep evaluation was performed by assessing number of participants who fell asleep in a particular pre-specified range of time duration, that is, 0-15 minutes, 16-30 minutes, 31-45 minutes, 46-60 minutes and greater than 60 minutes at Day 84 (Week 12).|Day 84 (Week 12)|Per protocol population (PPP) included all the treated participants who showed no major protocol violations and were compliant with study inclusion criteria and with the proper administration of the study drug.||participants|||Number
697610|NCT01364298|Secondary|Profile of Mood States (POMS) Score|"POMS is a rating scale, which comprises of 65 items that are evaluated in a 0-4 scale, where 0 means not at all and 4 extremely. The scores for the 65 items are added in various combinations to throw six validated factors which are used to calculate total POMS score: (tension-anxiety) + (depression-dejection) + (anger-hostility)+ (fatigue-Inertia) + (confusion-bewilderment) - (vigor-activity). Score range (-40 to 192). Score -40 denotes the best score and score 192 denotes the worst score."|Day 84 (Week 12)|Per protocol population (PPP) included all the treated participants who showed no major protocol violations and were compliant with study inclusion criteria and with the proper administration of the study drug.||units on a scale||Standard Deviation|Mean
697611|NCT01364298|Secondary|Change From Baseline in Visual Analogue Scale (VAS) Score at Day 84|VAS is used to rate the pain as per 10 centimeter (cm) line. The pain intensity score ranges from '0=no pain' to '10=worst possible pain'. Change from baseline data has been calculated as value at baseline minus value at Day 84.|Baseline and Day 84 (Week 12)|Per protocol population (PPP) included all the treated participants who showed no major protocol violations and were compliant with study inclusion criteria and with the proper administration of the study drug. 'n' signifies number of participants who were evaluable for specified categories at different time points.||centimeter||Standard Deviation|Mean
697612|NCT01364298|Secondary|Change From Baseline in Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Scale Score at Day 84|The LANSS scale score is 7-item pain scale that consists of grouped sensory description and sensory examination with simple scoring system. Evaluations in two main areas: pain and sensorial exploration. The ﬁrst 5 questions asks for presence of unpleasant skin sensations (pricking, tingling, pins and needles), appearance of skin (mottled, red, or pink), increased sensitivity of skin to touch, sudden bursts of electric shock sensations, and hot or burning skin sensations. Last 2 questions involve sensory testing for the presence of allodynia and altered pinprick threshold. Different numbers of points, relative to their signiﬁcance to neuropathic pain, are given to positive answers for maximum of 24 points. A score less than 12 makes unlikely that participant's symptoms are neuropathic in nature, whereas score more than 12 make neuropathic mechanisms likely to be contributing to participant's pain. Change from baseline data has been calculated as value at baseline minus value at Day 84.|Baseline and Day 84 (Week 12)|Per protocol population (PPP) included all the treated participants who showed no major protocol violations and were compliant with study inclusion criteria and with the proper administration of the study drug. 'n' signifies number of participants who were evaluable for specified categories at different time points.||units on a scale||Standard Deviation|Mean
697972|NCT01361633|Secondary|Trails B|Assesses executive functioning|Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up||||||
697613|NCT01364298|Primary|Change From Baseline in Average Numeric Pain Intensity Scale (NPIS) Score at Day 84|An average NPIS pain score (daily average records of the past seven days) was evaluated. Numeric pain intensity scale (NPIS) is a 11-point scale, with 0 representing no pain and 10 representing the worst possible pain. The participants were asked to mark the number that best represents the current level of pain they have experienced during the previous 24 hours. Change from baseline data has been calculated as value at baseline minus value at Day 84.|Baseline and Day 84 (Week 12)|Per protocol population (PPP) included all the treated participants who showed no major protocol violations and were compliant with study inclusion criteria and with the proper administration of the study drug. 'n' signifies number of participants who were evaluable for specified categories at different time points.||units on a scale||Standard Deviation|Mean
697614|NCT01364259|Secondary|Pain Relief Following Radiosurgery|Pain improvement as assessed by the Barrow Neurological Institute (BNI) facial pain score from pre-treatment baseline of BNI 3-5 (3-some pain/controlled on medications, 4-some pain/not controlled on medications, 5-severe pain) to BNI 1-2 (1-no pain/ no medication, 2- occasional pain/no medication)|1 year|8 subjects were enrolled on the Amifostine arm, however, one subject was enrolled but withdrew prior to treatment.||Participants|||Count of Participants
697615|NCT01364259|Primary|Facial Numbness Following Radiosurgery|Percent of patients with facial numbness following radiosurgery will be determined at one year follow up.|1 year|One subject randomized to drug arm did not have data.||Participants|||Count of Participants
697616|NCT01364207|Primary|Change in Intraocular Pressure at 90 Minutes|"At the caffeinated coffee visit: Change in intraocular pressure at 90 minutes = intraocular pressure at 90 minutes post caffeinated coffee ingestion minus intraocular pressure at baseline prior to caffeinated coffee ingestion
At the decaffeinated coffee visit: Change in intraocular pressure at 90 minutes = intraocular pressure at 90 minutes post decaffeinated coffee ingestion minus intraocular pressure at baseline prior to decaffeinated coffee ingestion"|Prior to coffee ingestion (baseline), 90 minutes post coffee ingestion|Only those 106 participants who completed both study visits were included in baseline and final data analyses. The 6 participants who did not complete both study visits were not included in any baseline or final data analyses.||mm Hg||Standard Deviation|Mean
697617|NCT01364207|Primary|Change in Intraocular Pressure at 60 Minutes|"At the caffeinated coffee visit: Change in intraocular pressure at 60 minutes = intraocular pressure at 60 minutes post caffeinated coffee ingestion minus intraocular pressure at baseline prior to caffeinated coffee ingestion
At the decaffeinated coffee visit: Change in intraocular pressure at 60 minutes = intraocular pressure at 60 minutes post decaffeinated coffee ingestion minus intraocular pressure at baseline prior to decaffeinated coffee ingestion"|Prior to coffee ingestion (baseline), 60 minutes post coffee ingestion|Only those 106 participants who completed both study visits were included in baseline and final data analyses. The 6 participants who did not complete both study visits were not included in any baseline or final data analyses.||mm Hg||Standard Deviation|Mean
697618|NCT01363986|Secondary|Brain Progression-Free Survival (B-PFS)|B-PFS was defined as the time from the date of first study drug assumption and the date of documented evidence of brain progression (defined as appearance of new brain metastases or progression of pre-existing lesions) or death for brain progression, whichever came first. Progression in other metastatic sites, deaths not due to brain-progression and withdrawals due to adverse events were to be considered as competing risk.|Baseline, weekly for 3 weeks (pre-WBRT phase), Cycles 1 through 15 (treatment phase Weeks 1 through 15), and 4 weeks after Cycle 15 (Week 15) or the last dose of study treatment|Due to the premature interruption of the study and the small number of enrolled participants (3 nerolled), all participant data were listed only, without any descriptive statistics or data analysis. The endpoint of B-PFS was thus not analyzed.|||||
697619|NCT01363986|Secondary|Overall Survival|The number of participants surviving at the final visit.|Baseline, weekly for 3 weeks (pre-WBRT phase), Cycles 1 through 15 (treatment phase Weeks 1 through 15), and 4 weeks after Cycle 15 (Week 15) or the last dose of study treatment|ITT population; survival status of 1 participant was unknown at the final visit.||participant|||Number
697620|NCT01363986|Secondary|Number of Participants With Brain Objective Response Defined According to RECIST Criteria at the Final Visit|Brain objective response was defined as either a CR or PR), provided that there was no increase in steroid requirements, or worsening of neurological signs and symptoms. CR was defined as the disappearance of all CNS lesions. PR was defined as ≥30% reduction in the volumetric sum of all measurable CNS lesions.|BL and 4 weeks after Cycle 15 (Week 15, approximately 13 weeks after completion of WBRT) or the last dose of study treatment|ITT population; 1 participant was not assessed at the final visit.||participant|||Number
697621|NCT01363986|Secondary|Number of Participants With Brain Objective Response According to RECIST Criteria at Cycle 15|Brain objective response was defined as either a CR or PR, provided that there was no increase in steroid requirements or worsening of neurological signs and symptoms. CR was defined as the disappearance of all CNS lesions. PR was defined as ≥30% reduction in the volumetric sum of all measurable CNS lesions.|Baseline and Cycle 15 (Week 15, approximately 13 weeks after completion of WBRT)|ITT population; 2 participants were not assessed at Cycle 15.||participants|||Number
697622|NCT01363986|Primary|Number of Participants With Brain Objective Response According to Response Evaluation Criteria In Solid Tumors (RECIST) Criteria at Cycle 7|Brain objective response was defined as either a complete response (CR) or partial response (PR), provided that there was no increase in steroid requirements or worsening of neurological signs and symptoms. CR was defined as the disappearance of all central nervous system (CNS) lesions. PR was defined as a greater than or equal to (≥) 30 percent (%) reduction in the volumetric sum of all measurable CNS lesions.|Baseline and Cycle 7 (Week 7, approximately 5 weeks after completion of whole brain radiotherapy [WBRT])|ITT population; 1 participant was not assessed at Cycle 7.||participants|||Number
697623|NCT01363908|Secondary|Change From Baseline in Serum Ferritin|Serum ferritin levels were assessed to determine if a participant was a successful responder and were determined from serum biochemistry analyses conducted at the central laboratories. A negative change from baseline indicates that serum ferritin decreased.|Baseline, 24 weeks, and 48 weeks|The FAS, defined as all participants in the Safety Analysis Set who had at least 1 post-baseline primary efficacy assessment, which was considered as the LICs assessed from FerriScan R2 MRI.||ng/mL||Standard Deviation|Mean
697973|NCT01361633|Secondary|Tower of London|Assesses executive functioning|Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up||||||
697626|NCT01363908|Secondary|Change From Baseline in LIC Assessed by R2* MRI|The efficacy of SPD602 was assessed by determining LIC. Abdominal MRI data were collected by using R2* standard procedures and used to determine LIC. A negative change from baseline indicates that LIC decreased.|Baseline, 24 weeks, and 48 weeks|The FAS, defined as all participants in the Safety Analysis Set who had at least 1 post-baseline primary efficacy assessment, which was considered as the LICs assessed from FerriScan R2 MRI.||mg Fe/g*dw||Standard Deviation|Mean
697627|NCT01363908|Primary|Change From Baseline in LIC Adjusted by Transfusional Iron Intake And Assessed by FerriScan R2 MRI|The efficacy of SPD602 was assessed by determining LIC and adjusting for transfusional iron intake. Abdominal MRI data were collected by using FerriScan R2 standard procedures and used to determine LIC. A negative change from baseline indicates that LIC decreased.|Baseline, 24 weeks, and 48 weeks|The FAS, defined as all participants in the Safety Analysis Set who had at least 1 post-baseline primary efficacy assessment, which was considered as the LICs assessed from FerriScan R2 MRI.||mg Fe/g*dw||Standard Deviation|Mean
697628|NCT01363908|Primary|Change From Baseline in Liver Iron Concentration (LIC) Assessed by FerriScan R2 Magnetic Resonance Imaging (MRI)|The efficacy of SPD602 was assessed by determining LIC. Abdominal MRI data were collected by using FerriScan R2 standard procedures and used to determine LIC. A negative change from baseline indicates that LIC decreased.|Baseline, 24 weeks, and 48 weeks|The Full Analysis Set (FAS), defined as all participants in the Safety Analysis Set who had at least 1 post-baseline primary efficacy assessment, which was considered as the LICs assessed from FerriScan R2 MRI.||mg Fe/g*dw||Standard Deviation|Mean
697629|NCT01363908|Primary|Fraction Of Orally Administered Drug Excreted Unchanged In Urine (fe) of SPD602 After a Single Oral Dose|The pharmacokinetic (PK) parameters of SPD602 were measured in urine of patients following a single capsule dose of SPD602 at 16 mg/kg at start of treatment on Day 1 and at the clinic visit on Day 2. Children who could cooperate provided urine samples for PK assessment on Day 1 over 3 time intervals: 0-4, 4-8, and 8-24 hours after the last dose (continued into Day 2). Urine concentrations of SPD602 were determined using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. The PK parameters were determined from urine concentration-time data for SPD602 (total) by non-compartmental analysis.|Day 1 and up to 24 hours post-dose|The PK set, defined as all participants in the Safety Analysis Set for whom the primary PK data were considered sufficient and interpretable.||percentage of total dose||Standard Deviation|Mean
697630|NCT01363908|Primary|Amount Excreted Into Urine (Ue) of SPD602 After a Single Oral Dose|The pharmacokinetic (PK) parameters of SPD602 were measured in urine of patients following a single capsule dose of SPD602 at 16 mg/kg at start of treatment on Day 1 and at the clinic visit on Day 2. Children who could cooperate provided urine samples for PK assessment on Day 1 over 3 time intervals: 0-4, 4-8, and 8-24 hours after the last dose (continued into Day 2). Urine concentrations of SPD602 were determined using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. The PK parameters were determined from urine concentration-time data for SPD602 (total) by non-compartmental analysis.|Day 1 and up to 24 hours post-dose|The PK set, defined as all participants in the Safety Analysis Set for whom the primary PK data were considered sufficient and interpretable.||mg||Standard Deviation|Mean
697631|NCT01363908|Primary|Renal Clearance (CLr) of SPD602 After a Single Oral Dose|The pharmacokinetic (PK) parameters of SPD602 were measured in urine of patients following a single capsule dose of SPD602 at 16 mg/kg at start of treatment on Day 1 and at the clinic visit on Day 2. Children who could cooperate provided urine samples for PK assessment on Day 1 over 3 time intervals: 0-4, 4-8, and 8-24 hours after the last dose (continued into Day 2). Urine concentrations of SPD602 were determined using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. The PK parameters were determined from urine concentration-time data for SPD602 (total) by non-compartmental analysis.|Day 1 and up to 24 hours post-dose|The PK set, defined as all participants in the Safety Analysis Set for whom the primary PK data were considered sufficient and interpretable.||L/h||Standard Deviation|Mean
697632|NCT01363908|Primary|Terminal Half-life (t1/2) of SPD602 After a Single Oral Dose|The pharmacokinetic (PK) parameters of SPD602 were measured in plasma of all patients following a single capsule dose of SPD602 at 16 mg/kg at start of treatment on Day 1 and at the clinic visit on Day 2. PK blood samples were collected as follows: Pre-dose on Day 1 (within 60 minutes prior to investigational product administration) and at 0.5, 1, 2, 3, 4, 8 hours (±3 minutes) and 24 hours (±30 minutes) post-dose. Plasma concentrations of SPD602 were determined using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. The PK parameters were determined from plasma concentration-time data for SPD602 (total) by non-compartmental analysis.|Day 1 and up to 24 hours post-dose|The PK set, defined as all participants in the Safety Analysis Set for whom the primary PK data were considered sufficient and interpretable.||hours||Standard Deviation|Mean
697633|NCT01363908|Primary|Area Under The Plasma Concentration-Time Curve (AUC) From The Time of Dosing to The Last Measurable Concentration (AUClast) of SPD602 After a Single Oral Dose|The pharmacokinetic (PK) parameters of SPD602 were measured in plasma of all patients following a single capsule dose of SPD602 at 16 mg/kg at start of treatment on Day 1 and at the clinic visit on Day 2. PK blood samples were collected as follows: Pre-dose on Day 1 (within 60 minutes prior to investigational product administration) and at 0.5, 1, 2, 3, 4, 8 hours (±3 minutes) and 24 hours (±30 minutes) post-dose. Plasma concentrations of SPD602 were determined using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. The PK parameters were determined from plasma concentration-time data for SPD602 (total) by non-compartmental analysis.|Day 1 and up to 24 hours post-dose|The PK set, defined as all participants in the Safety Analysis Set for whom the primary PK data were considered sufficient and interpretable.||h*mg/L||Standard Deviation|Mean
697634|NCT01363908|Primary|Time of Maximum Observed Plasma Concentration Sampled During a Dosing Interval (Tmax) of SPD602 After a Single Oral Dose|The pharmacokinetic (PK) parameters of SPD602 were measured in plasma of all patients following a single capsule dose of SPD602 at 16 mg/kg at start of treatment on Day 1 and at the clinic visit on Day 2. PK blood samples were collected as follows: Pre-dose on Day 1 (within 60 minutes prior to investigational product administration) and at 0.5, 1, 2, 3, 4, 8 hours (±3 minutes) and 24 hours (±30 minutes) post-dose. Plasma concentrations of SPD602 were determined using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. The PK parameters were determined from plasma concentration-time data for SPD602 (total) by non-compartmental analysis.|Day 1 and up to 24 hours post-dose|The PK set, defined as all participants in the Safety Analysis Set for whom the primary PK data were considered sufficient and interpretable.||hours||Full Range|Median
697635|NCT01363908|Primary|Maximum Observed Plasma Concentration (Cmax) of SPD602 After a Single Oral Dose|The pharmacokinetic (PK) parameters of SPD602 were measured in plasma of all patients following a single capsule dose of SPD602 at 16 mg/kg at start of treatment on Day 1 and at the clinic visit on Day 2. PK blood samples were collected as follows: Pre-dose on Day 1 (within 60 minutes prior to investigational product administration) and at 0.5, 1, 2, 3, 4, 8 hours (±3 minutes) and 24 hours (±30 minutes) post-dose. Plasma concentrations of SPD602 were determined using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. The PK parameters were determined from plasma concentration-time data for SPD602 (total) by non-compartmental analysis.|Day 1 and up to 24 hours post-dose|The Pharmacokinetic (PK) set, defined as all participants in the Safety Analysis Set for whom the primary PK data were considered sufficient and interpretable. The Safety Analysis Set was defined as all participants who had taken at least 1 dose of investigational product. Treatment assignment was based on the treatment actually received.||ng/mL||Standard Deviation|Mean
697636|NCT01363843|Secondary|Evaluate the Toxicity of Study Therapy|"Evaluate the toxicity of induction FOLFOX and subsequent infusional 5-FU or capecitabine/radiation.
•Secondary efficacy measures include the clinical response rate, as measured endorectal ultrasound or pelvic MRI, and incidence and severity of toxicities seen during the various phases of study treatment, including treatment delays, bleeding and post-op complications. Each visit will have a toxicity assessment completed"|approx 1 year||||||
697637|NCT01363843|Primary|Incidence of Complete Resection|The primary objective of this study is to determine the incidence of pCRs and complete (R0) resections at surgery after induction chemotherapy with 8 cycles of modified FOLFOX6 followed by standard chemoradiation with IMRT with concurrent infusional 5-FU or capecitabine|approx 6 months|||participants|||Number
697638|NCT01363765|Secondary|NRR of Negative-laboratory TB (Cluster-averaged).|"The notification rate (NR, i.e., number of notifications/100,000 population/year) ratio (NRR) is defined as the NR in the intervention period/NR in the observation period, and is presented in the statistical analysis section.
Numbers are driven from linkage between lab (all tests done) and notification databases; denominators are population taking into account growth of the population during the study period, adjusted for variations in monthly number of opening days (by weighing the number of person-months for the proportion of suspects with samples examined each month out of the total number examined by the laboratory during the whole study period), stratified by sex and age group.
Routine practices were not changed; patients with a high suspicion of TB were, as prior to the study, notified regardless of a confirmatory test."|October 2012 (up to 2 years)|||notifications/100,000 persons/year||95% Confidence Interval|Number
697639|NCT01363765|Secondary|NRR of Non-laboratory Tested TB (Cluster-averaged).|"The notification rate (NR, i.e., number of notifications/100,000 population/year) ratio (NRR) is defined as the NR in the intervention period/NR in the observation period, and is presented in the statistical analysis section.
Numbers are participants in the notification database who were not in the lab (all tests done) database; denominators are population taking into account growth of the population during the study period, adjusted for variations in monthly number of opening days (by weighing the number of person-months for the proportion of suspects with samples examined each month out of the total number examined by the laboratory during the whole study period), stratified by sex and age group.
Routine practices were not changed; patients with a high suspicion of TB were, as prior to the study, notified regardless of a confirmatory test."|October 2012 (up to 2 years)|The result is the notification rate ratio||notifications/100,000 persons/year||95% Confidence Interval|Number
697640|NCT01363765|Primary|Costs Per Detected Case|Costs per detected case were analyzed using a decision tree model from the national health system perspective. Incremental cost-effectiveness ratio (ICER) was calculated as (costs with Xpert - costs with smears)/(cases detected with Xpert - cases detected with smears). Negative ICERs mean cost saving.|October 2012 (up to 2 years)|||American dollars|||Number
697641|NCT01363765|Primary|Notification Rate Ratio|Proportion of additional bacteriologically confirmed notified TB cases during intervention period compared to the observation period Patients notified who had a positive test result. The notification rate (NR, i.e., number of notifications/100,000 population/year) ratio (NRR) is defined as the NR in the intervention period/NR in the observation period, and is presented in the statistical analysis section.|October 2012 (up to 2 years)|Only patients found both in laboratory and in the notification databases were included since this is an outcome based on notification rates. Population growth during time was estimated. NR per 100,000 population||notifications/100,000 persons/year||95% Confidence Interval|Number
697642|NCT01363713|Other Pre-specified|Change in Bulbar Conjunctiva Hyperemia Score by Visit|"Change from baseline of bulbar conjunctiva hyperemia score. Bulbar conjunctiva hyperemia was assessed by the investigator and graded on a 4 points scale of 0-3 (0=none and 3= extremely severe).
The main purpose of this study is not to confirm but to evaluate safety of long term use of this drug, so primary variable was not defined."|From baseline to 8-week|||score||Standard Error|Mean
697643|NCT01363713|Other Pre-specified|Change in Palpebral Hyperemia Score by Visit|"Change from baseline of palpebral hyperemia score. Palpebral hyperemia was assessed by the investigator and graded on a 4 points scale of 0-3 (0=none and 3= extremely severe).
The main purpose of this study is not to confirm but to evaluate safety of long term use of this drug, so primary variable was not defined."|From baseline to 8-week|||score||Standard Error|Mean
697644|NCT01363713|Primary|Change in Ocular Itching Score by Visit|"Change from baseline in the average of Ocular itching score over the past 3 days. Ocular itching was assessed by the subject and graded on a 5 points scale of 0-4 (0=no itching, 4=incapacitating itch).
The main purpose of this study is not to confirm but to evaluate safety of long term use of this drug, so primary variable was not defined."|From baseline to 8-week|||score||Standard Error|Mean
697645|NCT01363700|Secondary|Mean Hyperemia Score Compared to Olopatadine Period2|"A conjunctivitis allergic challenge (CAC) was performed 4 hours after drop instillation. Mean palpebral and bulbar conjunctiva hyperemia was assessed by the investigator at 5, 10, and 20 min post challenge and graded on a 4 points scale of 0-3 (0=none and 3= extremely severe). Total hyperemia score is defined as the sum of the palpebral and bulbar conjunctiva scores.
The endpoint used the average score of three time points (5, 10, and 20 minutes) after allergen challenge ."|Visit 7 (5, 10, and 20 minutes post-CAC)|||score||Standard Error|Mean
697974|NCT01361633|Secondary|Wisconsin Card Sort Test|Assesses executive functioning|Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up||||||
697647|NCT01363700|Primary|Mean Hyperemia Score Compared to Placebo Period1|"A conjunctivitis allergic challenge (CAC) was performed 4 hours after drop instillation. Mean palpebral and bulbar conjunctiva hyperemia was assessed by the investigator at 5, 10, and 20 min post challenge and graded on a 4 points scale of 0-3 (0=none and 3= extremely severe). Total hyperemia score is defined as the sum of the palpebral and bulbar conjunctiva scores. Count unit was defined each eye.
The endpoint used the average score of three time points (5, 10, and 20 minutes) after allergen challenge ."|Visit 5 (5, 10, and 20 minutes post-CAC)|||score||Standard Error|Mean
697648|NCT01363700|Primary|Mean Ocular Itching Score Compared to Placebo Period1|"A conjunctivitis allergic challenge (CAC) was performed 4 hours after drop instillation. Mean ocular itching score was assessed by the subject at 3, 5, and 10 min post challenge and graded on a 5 points scale of 0-4 where 0=no itching and 4=incapacitating itch. Count unit was defined each eye.
The endpoint used the average score of three time points (3, 5, and 10 minutes) after allergen challenge ."|Visit 5 (3, 5, and 10 minutes post-CAC)|||score||Standard Error|Mean
697649|NCT01363661|Secondary|Frequency of AEs and SAEs in the Two Groups After Twelve Months of Treatment (Month 12).|Sum of the events collected during 12 months.|Month 12|Intention-to-treat population||Number of events|||Number
697650|NCT01363661|Secondary|Frequency of Serious Cardiovascular Events (SCEs) in the Two Groups After Twelve Months of Treatment (Month 12).|Sum of the events collected during 12 months.|Month 12|Intention-to-treat population||Number of events|||Number
697651|NCT01363661|Secondary|Change Versus Baseline in Some Specific Endothelial Biomarkers After Twelve Months of Treatment (Month 12).||Month 12|Per protocol population||Relative change versus baseline (%)||Standard Deviation|Mean
697652|NCT01363661|Secondary|Change Versus Baseline in the Augmentation Index in the Two Groups After Six and Twelve Months of Treatment (Months 6 and 12).|The results are expressed mean relative change (%) between month 6 or month 12, and baseline. A positive result means improvement in the augmentation index between baseline and month 6 or month 12. It could be considered as a surrogate of a decrease of the arterial stiffness. A negative percentage means the inverse. The are no fixed limits to the scale. At month 6,the minimum observed was -139% and the maximum observed was +1600%.At month 12, the minimum observed was -524% and the maximum observed was +1600%.|Month 6 and Month 12|Per protocol population||Relative change versus baseline (%)||Standard Deviation|Mean
697653|NCT01363661|Secondary|Change Versus Baseline in the Score of the EndoPAT in the Two Groups After Six Months of Treatment (Month 6).|The results are expressed mean relative change (%) between month 6 and baseline. A positive result means improvement in the score of the EndoPAT between baseline and month 6. It could be considered as a surrogate of a decrease of the endothelial dysfunction. A negative percentage means the inverse. The are no fixed limits to the scale. The minimum observed was -200% and the maximum observed was +6100%.|Month 6|Per protocol population||Relative change versus baseline (%)||Standard Deviation|Mean
697654|NCT01363661|Primary|Change Versus Baseline in the Score of the EndoPAT in the Two Groups After One Year of Treatment (Month 12).|The results are expressed mean relative change (%) between month 12 and baseline. A positive result means improvement in the score of the EndoPAT between baseline and month 12. It could be considered as a surrogate of a decrease of the endothelial dysfunction. A negative percentage means the inverse. The are no fixed limits to the scale. The minimum observed was -275% and the maximum observed was +4200%.|12 months|Per protocol population||Relative change versus baseline (%)||Standard Deviation|Mean
697655|NCT01363492|Primary|Change From Baseline in Heart Rate Variability Parameter pNN50||Baseline to week 55|||msec||Standard Deviation|Mean
697656|NCT01363492|Primary|Change From Baseline in Heart Rate Variability Parameter rMSSD||Baseline to week 55|||msec||Standard Deviation|Mean
697657|NCT01363492|Primary|Change From Baseline in Heart Rate Variability Parameter SDNN||Baseline to week 55|||msec||Standard Deviation|Mean
697658|NCT01363492|Secondary|Change From Baseline in Urine Gb3||Baseline to week 55|||(nmol/g creatinine)||Standard Deviation|Mean
697659|NCT01363492|Secondary|Change From Baseline in Plasma Gb3||Baseline to week 55|||(nmol/mL)||Standard Deviation|Mean
697660|NCT01363492|Secondary|Change From Baseline in MFS||Baseline to week 55|||(%)||Standard Deviation|Mean
697661|NCT01363492|Secondary|Change From Baseline in LVMI||Baseline to week 55|||(g/m^2.7)||Standard Deviation|Mean
697662|NCT01363492|Primary|Development of IgG Anti-Agalsidase Alfa Antibody|Reflects development of Anti-Agalsidase antibodies post baseline|Baseline to Week 55|||participants|||Number
697663|NCT01363492|Primary|Number of Treatment Emergent Adverse Event (TEAE)||Baseline to week 55|||events|||Number
697664|NCT01363492|Primary|Number of Serious Adverse Event (SAE)||Baseline to week 55|||events|||Number
697668|NCT01363440|Secondary|Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Distance Activities Subscale at Week 52 - LOCF|The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales that are all scored from 0-100. Distance activities are defined as reading street signs or names on stores, and going down stairs, steps, or curbs.|Baseline and Week 52|||scores on a scale||Standard Error|Least Squares Mean
697669|NCT01363440|Secondary|Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Near Activities Subscale at Week 52 - LOCF|The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales that are all scored from 0-100. Near activities are defined as reading ordinary print in newspapers, performing work or hobbies requiring near vision, or finding something on a crowded shelf.|Baseline and Week 52|||scores on a scale||Standard Error|Least Squares Mean
697670|NCT01363440|Secondary|Change From Baseline in Central Retinal Thickness (CRT) at Week 52 as Assessed on Optical Coherence Tomography (OCT) - LOCF||Baseline and Week 52|||microns||Standard Error|Least Squares Mean
715711|NCT00259272|Secondary|Increases and Decreases in Fasting Glucose Levels||over 24 weeks|Safety Population. All participants having been prescribed at least one dose of study drug.||participants|||Number
697671|NCT01363440|Secondary|Percentage of Participants With a ≥2-step Improvement From Baseline in the ETDRS DRSS (Diabetic Retinopathy Severity Score) as Assessed by FP (Fundus Photography) at Week 52 - LOCF|Baseline ETDRS DRSS: None (level 10); Mild to moderate nonproliferative DR (levels 14, 15, 20, 35, and 43); Moderately severe/severe nonproliferative DR (levels 47 and 53); Mild/moderate/high-risk/advanced proliferative DR (levels 61, 65, 71,75, 81, and 85)|Baseline and Week 52|||percentage of participants|||Number
697672|NCT01363440|Secondary|Percentage of Participants Who Gained at Least 15 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF||Baseline and Week 52|||percentage of participants|||Number
697673|NCT01363440|Secondary|Percentage of Participants Who Gained at Least 10 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF||Baseline and Week 52|All secondary efficacy endpoints were analyzed using the full analysis set (FAS). The FAS included all 'Participants received Treatment' and had a baseline and at least 1 post-baseline assessment of Best Corrected Visual Acuity (BCVA).||percentage of participants|||Number
697674|NCT01363440|Primary|Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 52 - Last Observation Carried Forward (LOCF)|Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of 73 to 24 (= Acuity of 20/40 to 20/320) in the study eye were included; a higher score represents better functioning.|Baseline and Week 52|The Primary efficacy endpoint was analyzed using the full analysis set (FAS). The FAS included all 'Participants received Treatment' and had a baseline and at least 1 post-baseline assessment of Best Corrected Visual Acuity (BCVA).||letters correctly read||Standard Error|Least Squares Mean
697675|NCT01363401|Secondary|Change in SF-36 (The Short Form (36) Health Survey is a 36 Item)|"The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score presents more severe disability. The higher the score presents less disability.
This was measured at Visit 5 and Visit 9. (week 0,16) The first injection was performed at 0 week.
The score variation baseline(Visit 5) and week 16(Visit 9)"|baseline(Visit 5) and week 16(Visit 9)|The SF-36 was assessed except Two participants of no treatment group, because 1) ICU admissions for breathing therapy 2) Patients reject the measurement.||point||Standard Deviation|Mean
697676|NCT01363401|Secondary|Change in Forced Vital Capacity (FVC) (Percent of Predicted Normal)|"Secondary efficacy was measured by comparing the rate of decline of mean FVC by treatment group.
FVC which is a clinical scale to observe variation in patient’s respiratory competence, was conducted at Visit 1, Visit 5 and Visit 9. (week -12,0,16) The first injection was performed at 0 week. FVC variation baseline(Visit 5) and week 16(Visit 9)"|baseline(Visit 5) and week 16(Visit 9)|"One of the test group, FVC was assessed except because received tracheostomy during the clinical trial.
FVC was assessed except Two participants of no treatment group because 1) ICU admissions for breathing therapy 2) Patients reject the measurement"||percent of prediceted||Standard Deviation|Mean
697677|NCT01363401|Secondary|Change in Appel Scale|"To evaluate the disease change, Appel scale will be assessed. Appel scale is a test tool, which is devised to evaluate the functional condition and variation of ALS(Lou Gehrig’s disease) patients (rating 6 to between 30 and 36 points for each of 5 functional conditions, 30-164 total).
The higher the total score presents more severe disability. This was done at Visit 1, Visit 5 and Visit 9 (week -12,0,16). The first injection was performed at 0 week(Visit 5) Appel scale total score variation baseline(Visit 5) and week 16(Visit 9)"|baseline(Visit 5) and week 16(Visit 9)|Apple scale was assessed except Two participants of No treatment group, because 1) ICU admissions for breathing therapy 2) Patients reject the measurement.||point||Standard Deviation|Mean
697678|NCT01363401|Primary|The Difference in the Changes of Amyotrophic Lateral Sclerosis Functional Rating Scale – Revised (ALSFRS-R) Between Treatment Groups and Control Groups.|ALSFRS-R is ordinal rating scale questionnaire (rating 0-4 for each question, 4 is most functional, 0-48 total) of 12 functional activities. The most functional total score is 48. ALSFRS-R was evaluated at baseline and week 28.(The first injection was performed at 0 week) ALSFRS-R total score variation baseline(Visit 5) and week 16(Visit 9)|baseline(Visit 5) and week 16(Visit 9)|The ALSFRS-R score was assessed by all the subjects in Phase 1/2 clinical trials.||score on a scale||Standard Deviation|Mean
697679|NCT01363349|Secondary|Long Term Schizophrenia Treatment|Evaluation of the antipsychotic efficacy of BL-1020 compared to risperidone after 6, 12 and 24 weeks of treatment|Baseline and 6, 12 and 24 weeks of treatment||||||
697680|NCT01363349|Secondary|Long Term Cognition|Evaluation of the cognitive benefits of treatment with BL-1020 compared to risperidone after 12 and 24 weeks of treatment|12 and 24 weeks of treatment||||||
697681|NCT01363349|Primary|Cognition|To evaluate the cognitive benefits of treatment with CYP-1020 (formerly known as BL-1020) compared to risperidone after 6 weeks of treatment in patients experiencing acute exacerbation of schizophrenia. Assessed by calculating difference between CYP-1020 and Risperidone on mean change from baseline to Week 6 endpoint on MATRICS Consensus Cognition Battery (MCCB) normative composite score. MCCB is a neuropsychological test battery that comprises 10 measures of 7 different cognitive areas including speed of processing, verbal learning, memory-verbal and non verbal reasoning and problem solving, visual learning, social cognition, attention/vigilance.The study was terminated after the interim analysis. MCBB total score ranges from -50 to 150. Change from Baseline by Visit (LOCF)Higher score means better cognitive functioning.|Baseline and 6 weeks|Analysis for MCCB Score ITT population.||Scores on a scale||Standard Deviation|Mean
697696|NCT01363297|Secondary|Percentage of Participants With CR, CRi or PR in Phase 2|CR was defined as a disappearance of leukemia as indicated by <5% marrow blasts and the absence of peripheral blood leukemic blasts, with recovery of hematopoiesis defined by ANC ≥1000/µL and platelets ≥100,000/µL. C1 extramedullary disease status was required. CRi was defined as CR except with ANC <1000/µL and/or platelets <100,000/µL. PR was defined as an improved or no worsening of acute lymphocytic leukemia as indicated by no peripheral blood blasts, and either or both of the following: at least a 50% decrease in the marrow blast percentage, compared to the pre-treatment value, and marrow blast percentage ≥5% and ≤25% and/or C2 extramedullary disease status.|From screening to progressive disease or another induction therapy started, up to approximately 2 years|Safety analysis set||Percentage of Partcicipants||95% Confidence Interval|Number
697975|NCT01361633|Secondary|Logical Memory Subtests|Measures verbal memory recall|Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up||||||
697682|NCT01363297|Secondary|Messenger Ribonucleic Acid (mRNA) Gene Expression|Optional blood samples for pharmacogenomic parameters were collected during Cycle 1 prior to the start of the inotuzumab ozogamicin infusion (0 hours) and 1 hour post-dose (original Final Protocol and Protocol Amendments 1 and 2) or 3 hours post-dose (Protocol Amendments 3 and 4) on Day 1 and Day 15 from those participants who provided consent. Gene expression analysis of samples collected pre- and post-dosing was performed using 96-gene TaqMan® low density array cards to examine the concordance between clinical outcome and expression of genes such as those involved in DNA damage response, apoptosis, B-cell antigen expression, glutathione metabolism, drug transport and the phosphoinositide 3-kinase/mammalian target of rapamycin pathway. Expression for each gene was reported as a normalized value, 2^–change in (∆) threshold cycle (Ct), where ∆Ct is Ct^target gene minus Ct^reference genes, averaged.|Predose and postdose on Days 1 and 15 of Cycle 1|Pharmacogenomics population - included all enrolled participants who received at least 1 dose of any study drug, and had at least 1 biomarker parameter from the corresponding assay sample with both a baseline and post-treatment assessment.||Fold expression||Full Range|Median
697683|NCT01363297|Secondary|Percentage of CD22+ Leukemic Blasts in Abnormal B Cells in Bone Marrow by Visit|CD22+ leukemic blasts assessed in abnormal B cells from bone marrow (data from central laboratories only).|Pre-dose on Days 1 and 15 of Cycles 1 and 2, and Day 1 of Cycle 4|Safety analysis set||Percentage of CD22+||Full Range|Median
697684|NCT01363297|Secondary|Percentage of Cluster of Differentiation-22 Positive (CD22+) Leukemic Blasts in Abnormal B Cells in Blood by Visit|CD22+ leukemic blasts assessed in abnormal B cells from blood (data from central laboratories only).|Pre-dose on Days 1 and 15 of Cycles 1 and 2, and Day 1 of Cycle 4|Safety analysis set||Percentage of CD22+||Full Range|Median
697685|NCT01363297|Secondary|Duration of Follow-Up|Duration of follow-up was defined as the time from the date of first dose of study drug to the date of last contact for participants known to be alive.|From first dose up to approximately 2 years|Participants who were alive||Months||95% Confidence Interval|Median
697686|NCT01363297|Secondary|Time to MRD Negativity for Participants Who Achieved CR or CRi|Time to MRD negativity was defined as the time from the date of first dose of study drug to the date of first documentation of MRD negativity.|Screening, Day 21 of Cycles 1 to 6 and up to 4 to 6 weeks after the last dose (up to 34 weeks)|All participants who achieved CR/CRi and MRD negativity.||Days||Full Range|Median
697687|NCT01363297|Secondary|Time to Response for Participants Who Achieved CR/CRi or PR|Time to response was defined as the time from the date of first dose of study drug to the date of first documentation of hematologic response (CR, CRi, or PR).|Up to approximately 2 years from first dose|All participants who achieved CR, CRi or PR.||Days||Full Range|Median
697688|NCT01363297|Secondary|Time to Remission for Participants Who Achieved CR or CRi|Time to remission was defined as the time from the date of first dose of study drug to the date of first documentation of hematologic remission (CR or CRi) in participants achieving remission during study therapy.|Up to approximately 2 years from first dose|All participants who achieved CR or CRi||Days||Full Range|Median
697689|NCT01363297|Secondary|Overall Survival (OS)|OS was defined as the time from Cycle 1 Day 1 to date of death due to any cause. If death was not documented, censoring occurred at the date at which the participant was last known to be alive.|Up to approximately 2 years from first dose|Safety analysis set||Months||95% Confidence Interval|Median
697690|NCT01363297|Secondary|Duration of Response (DoR) for Participants Who Achieved CR/CRi or PR|DoR was defined for participants who respond as the time from the date of first documentation of Hematologic Response (CR, CRi, or PR) to the date of the first documentation of DoR event (earliest date of PD, treatment discontinuation due to global deterioration of health status, first induction therapy or transplant after PR, relapse after CR or CRi or death due to any cause). Participants last known to be 1) alive and 2) without a DoR event, were censored at the date of the last disease assessment that verified lack of event.|Up to approximately 2 years from first dose|All participants who achieved CR, CRi or PR.||Weeks||95% Confidence Interval|Median
697691|NCT01363297|Secondary|Duration of Remission (DoR1) for Participants Who Achieved CR or CRi|DoR1 was defined for participants who responded as the time from the date of first documentation of Complete Hematologic Response (CR or CRi) to the date of the first documentation of relapse after CR or CRi, treatment discontinuation due to global deterioration of health status) or to death due to any cause. Participants last known to be 1) alive and 2) without a DoR1 event, were censored at the date of the last disease assessment that verified lack of event.|Up to approximately 2 years from first dose|All participants who achieved CR or CRi||Months||95% Confidence Interval|Median
697692|NCT01363297|Secondary|Progression Free Survival (PFS)|PFS was defined as the time from Cycle 1 Day 1 to first documentation of PFS event (earliest date of objective progression [PD], treatment discontinuation due to global deterioration of health status, subsequent induction or transplant after best response of PR or resistant disease, relapse after CR or CRi, or death due to any cause). Participants last known to be 1) alive and 2) without a PFS event, were censored at the date of the last disease assessment that verified lack of event.|Up to approximately 2 years from first dose|Safety analysis set||Months||95% Confidence Interval|Median
697693|NCT01363297|Secondary|Percentage of Participants Who Had a Post-Treatment Stem-Cell Transplant (SCT)|Post-treatment SCT rate was defined as the percentage of participants who underwent SCT following treatment with inotuzumab ozogamicin.|Up to approximately 2 years from first dose|Safety analysis set||Percentage of Particicpants|||Number
697694|NCT01363297|Secondary|Percentage of Participants With CR or CRi by Cytogenetic Category|CR was defined as a disappearance of leukemia as indicated by <5% marrow blasts and the absence of peripheral blood leukemic blasts, with recovery of hematopoiesis defined by ANC ≥1000/µL and platelets ≥100,000/µL. C1 extramedullary disease status was required. CRi was defined as CR except with ANC <1000/µL and/or platelets <100,000/µL.|From screening to progressive disease or another induction therapy started, up to approximately 2 years|Safety analysis set (n refers to number of participants evaluated)||Percentage of Participants|||Number
697695|NCT01363297|Secondary|Number of Participants With Minimal Residual Disease (MRD) Negativity in Participants Achieving CR and CRi|MRD negativity was defined as <0.01% mononuclear cells.|From screening to progressive disease or another induction therapy started, up to approximately 2 years|Number of participants who achieved CR and CRi||Participants|||Number
697976|NCT01361633|Secondary|Controlled Oral Word Association Test|Measure of a person's ability to make verbal associations to specified letters.|Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up||||||
697697|NCT01363297|Primary|Percentage of Participants With CR, CRi or PR During the Phase 1 Expansion Phase|CR was defined as a disappearance of leukemia as indicated by <5% marrow blasts and the absence of peripheral blood leukemic blasts, with recovery of hematopoiesis defined by ANC ≥1000/µL and platelets ≥100,000/µL. C1 extramedullary disease status was required. CRi was defined as CR except with ANC <1000/µL and/or platelets <100,000/µL. PR was defined as an improved or no worsening of acute lymphocytic leukemia as indicated by no peripheral blood blasts, and either or both of the following: at least a 50% decrease in the marrow blast percentage, compared to the pre-treatment value, and marrow blast percentage ≥5% and ≤25% and/or C2 extramedullary disease status.|From screening to progressive disease or another induction therapy started, up to approximately 2 years|Safety analysis set||Percentage of Partcicipants||95% Confidence Interval|Number
697698|NCT01363297|Primary|Percentage of Participants With CR or CRi During Phase 2|CR was defined as a disappearance of leukemia as indicated by <5% marrow blasts and the absence of peripheral blood leukemic blasts, with recovery of hematopoiesis defined by ANC ≥1000/µL and platelets ≥100,000/µL. C1 extramedullary disease status was required. CRi was defined as CR except with ANC <1000/µL and/or platelets <100,000/µL.|From screening to progressive disease or another induction therapy started, up to approximately 2 years|Safety analysis set||Percentage of Partcicipants||90% Confidence Interval|Number
697699|NCT01363297|Primary|Percentage of Participants With Preliminary Satisfactory Response (Complete Response [CR], CR With Incomplete Count Recovery [CRi], Partial Response [PR], or Resistant Disease [RD]) Indicating Disease Stability After First Dose During Phase 1 Dose-Finding|CR was the disappearance of leukemia indicated by <5% marrow blasts and absence of peripheral blood leukemic blasts, with recovery of hematopoiesis defined by ANC ≥1000/µL and platelets ≥100,000/µL. C1 extramedullary disease status was required. CRi was as for CR except with ANC <1000/µL and/or platelets <100,000/µL. PR was an improved or no worsening of acute lymphocytic leukemia indicated by no peripheral blood blasts, and/or at least a 50% decrease in the marrow blast percentage, compared to pre-treatment value, and marrow blast percentage ≥5% and less than or equal to (≤)25% and/or C2 extramedullary disease status. RD occurred if a participant survived ≥7 days following completion of initial treatment course and had persistent leukemia in the most recent peripheral blood smear or bone marrow and/or persistent disease involvement at any extramedullary site after completion of therapy.|From screening to progressive disease or another induction therapy started, up to approximately 2 years|Safety analysis set||Percentage of Participants|||Number
697700|NCT01363297|Primary|Percentage of Participants Reporting Dose Limiting Toxicities (DLTs) During the Phase 1 Dose-Finding Phase|DLT was any of the following in the first cycle & attributable to inotuzumab ozogamicin: any greater than or equal to (≥) Grade 4 non-hematologic toxicity except nausea/vomiting (if manageable with supportive care), alopecia, & toxicities secondary to neutropenia & sepsis; prolonged myelosuppression (absolute neutrophil count [ANC] less than [<] 500 per microliter [/µL] or platelet count <25,000/µL in bone marrow with <5 percent (%) blasts & no evidence of leukemia more than 45 days beyond the most recent dose of test article); any Grade 3 non-hematologic toxicity (excluding toxicities such as alopecia or those secondary to neutropenia & sepsis) not resolving to ≥ Grade 2 within 7 days of the most recent dose of test article or was clinically significant irrespective of duration; any ≥ Grade 3 elevation of alanine aminotransferase, aspartate aminotransferase or bilirubin lasting ≥7 days; any test article related toxicity resulting in permanent discontinuation of test article.|Cycle 1|Safety analysis set||Percentage of Participants|||Number
697701|NCT01363076|Primary|MRT (Mean Residence Time)|Pharmacokinetic analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each dose level, together with the individual plasma concentrations of ketorolac.|All PK parameters were assessed using blood samples collected 15 minutes prior to the dose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, and 24 hours after the dose|||hr||Standard Deviation|Mean
697702|NCT01363076|Primary|t1/2 (the Terminal Half-life, Where Possible)|Pharmacokinetic analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each dose level, together with the individual plasma concentrations of ketorolac.|All PK parameters were assessed using blood samples collected 15 minutes prior to the dose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, and 24 hours after the dose|||hr||Standard Deviation|Mean
697703|NCT01363076|Primary|AUC 0-24 (the AUC From Time Zero to 24 Hours Post-dose|Pharmacokinetic analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each dose level, together with the individual plasma concentrations of ketorolac.|All PK parameters were assessed using blood samples collected 15 minutes prior to the dose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, and 24 hours after the dose|||ng•h/mL||Standard Deviation|Mean
697704|NCT01363076|Primary|AUCinf (the AUC Time From Zero to Infinity, Where Possible)|Pharmacokinetic analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Pro. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each dose level, together with the individual plasma concentrations of ketorolac. AUCinf calculated as: AUCinf = AUC(0-24) + (concentration at 24 hr/elimination constant).|All PK parameters were assessed using blood samples collected 15 minutes prior to the dose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, and 24 hours after the dose|||ng•h/mL||Standard Deviation|Mean
697705|NCT01363076|Primary|AUClast (the Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Last Quantifiable Timepoint Post-dose)|Pharmacokinetic analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each dose level, together with the individual plasma concentrations of ketorolac.|All PK parameters were assessed using blood samples collected 15 minutes prior to the dose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, and 24 hours after the dose|||ng•h/mL||Standard Deviation|Mean
697977|NCT01361633|Secondary|Continuous Performance Test|Assesses Sustained Attention|Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up||||||
697706|NCT01363076|Primary|Tmax (The Time to Maximum Observed Plasma Concentration; ie. The Time at Which Cmax Occured)|Pharmacokinetic analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Pro. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each dose level, together with the individual plasma concentrations of ketorolac. Individual plasma ketorolac concentrations were summarized by dose level for the PK population at each sampling time using n, arithmetic mean, SD, CV(%), geometric mean, 95% confidence intervals (CI) for the arithmetic mean, median, minimum, and maximum.|All PK parameters were assessed using blood samples collected 15 minutes prior to the dose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, and 24 hours after the dose|||hr||Full Range|Median
697707|NCT01363076|Primary|Cmax (the Maximum Observed Plasma Concentration)|Pharmacokinetic analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each dose level, together with the individual plasma concentrations of ketorolac.|All PK parameters were assessed using blood samples collected 15 minutes prior to the dose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, and 24 hours after the dose|||ng/mL||Standard Deviation|Mean
697708|NCT01363050|Primary|MRT (the Mean Residence Time|PK analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each treatment, together with the individual plasma concentrations of ketorolac.|Blood samples for determination of plasma concentration of ketorolac were taken immediately prior to each dose and every hour for 8 hours post-dose on Day 3 (morning doses)|Two subjects were considered pharmacokinetic outliers and were excluded from the PK population.||hours||Standard Deviation|Mean
697709|NCT01363050|Primary|AUCτ (the Area Under the Plasma Concentration-time Curve Over the Dosing Interval at Steady-state)|PK analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each treatment, together with the individual plasma concentrations of ketorolac.|Blood samples for determination of plasma concentration of ketorolac were taken immediately prior to each dose and every hour for 8 hours post-dose on Day 3 (morning doses)|Two subjects were considered pharmacokinetic outliers and were excluded from the PK population.||ng*hours/mL||Standard Deviation|Mean
697710|NCT01363050|Primary|Tmin,ss (the Time to Minimum Concentration at Steady State)|PK analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each treatment, together with the individual plasma concentrations of ketorolac.|Blood samples for determination of plasma concentration of ketorolac were taken immediately prior to each dose and every hour for 8 hours post-dose on Day 3 (morning doses)|Two subjects were considered pharmacokinetic outliers and were excluded from the PK population.||hours||Full Range|Median
697711|NCT01363050|Primary|Cmin,ss (the Minimum Observed Plasma Concentration at Steady State)|PK analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each treatment, together with the individual plasma concentrations of ketorolac.|Blood samples for determination of plasma concentration of ketorolac were taken immediately prior to each dose and every hour for 8 hours post-dose on Day 3 (morning doses)|Two subjects were considered pharmacokinetic outliers and were excluded from the PK population.||ng/mL||Standard Deviation|Mean
697712|NCT01363050|Primary|Tmax,ss (the Time to Maximum Concentration at Steady State)|PK analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each treatment, together with the individual plasma concentrations of ketorolac.|Blood samples for determination of plasma concentration of ketorolac were taken immediately prior to each dose and every hour for 8 hours post-dose on Day 3 (morning doses)|Two subjects were considered pharmacokinetic outliers and were excluded from the PK population.||hours||Full Range|Median
697713|NCT01363050|Primary|Cmax,ss (the Maximum Observed Plasma Concentration at Steady State)|PK analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each treatment, together with the individual plasma concentrations of ketorolac.|Blood samples for determination of plasma concentration of ketorolac were taken immediately prior to each dose and every hour for 8 hours post-dose on Day 3 (morning doses)|Two subjects were considered pharmacokinetic outliers and were excluded from the PK population.||ng/mL||Standard Deviation|Mean
697714|NCT01363050|Primary|AUC 0-8h (the Area Under the Plasma Concentration-time Curve From Time 0 to 8 Hours Post-dose)|PK analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each treatment, together with the individual plasma concentrations of ketorolac.|Blood samples for determination of plasma concentration of ketorolac were taken immediately prior to each dose and every hour for 8 hours post-dose on Day 1 (morning doses)|Two subjects were considered pharmacokinetic outliers and were excluded from the PK population.||ng*hours/mL||Standard Deviation|Mean
697715|NCT01363050|Primary|Tmax (the Time to Maximum Concentration)|PK analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each treatment, together with the individual plasma concentrations of ketorolac.|Blood samples for determination of plasma concentration of ketorolac were taken immediately prior to each dose and every hour for 8 hours post-dose on Day 1 (morning doses)|Two subjects were considered pharmacokinetic outliers and were excluded from the PK population.||hours||Full Range|Median
697731|NCT01363011|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 (Cohort 1)|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed in Cohort 1 (treatment-naive) using the FDA snapshot analysis algorithm.|Week 24|Full Analysis Set (treatment-naive only): participants in the treatment-naive group who were randomized and received at least one dose of study drug||percentage of participants|||Number
697716|NCT01363050|Primary|Cmax (the Maximum Observed Plasma Concentration)|PK analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each treatment, together with the individual plasma concentrations of ketorolac.|Blood samples for determination of plasma concentration of ketorolac were taken immediately prior to each dose and every hour for 8 hours post-dose on Day 1 (morning doses)|Two subjects were considered pharmacokinetic outliers and were excluded from the PK population.||ng/mL||Standard Deviation|Mean
697717|NCT01363011|Secondary|Plasma Pharmacokinetics of COBI: t1/2 (Cohort 2)|t1/2 was analyzed for Cohort 2 (treatment-experienced) and was defined as the estimate of the terminal elimination half-life of the drug.|Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24.|Participants in the PK/PD Substudy Analysis Set (treatment-experienced only) with available postbaseline data were analyzed.||hours||Inter-Quartile Range|Median
697718|NCT01363011|Secondary|Plasma Pharmacokinetics of COBI: t1/2 (Cohort 1)|t1/2 was analyzed for Cohort 1 (treatment-naive) and was defined as the estimate of the terminal elimination half-life of the drug.|Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24.|PK/PD Substudy Analysis Set (treatment-naive only)||hours|||Number
697719|NCT01363011|Secondary|Plasma Pharmacokinetics of COBI: Tmax (Cohort 2)|Tmax was analyzed for Cohort 2 (treatment-experienced) and was defined as the time of Cmax.|Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24.|Participants in the PK/PD Substudy Analysis Set (treatment-experienced only) with available postbaseline data were analyzed.||hours||Inter-Quartile Range|Median
697720|NCT01363011|Secondary|Plasma Pharmacokinetics of COBI: Tmax (Cohort 1)|Tmax was analyzed for Cohort 1 (treatment-naive) and was defined as the time of Cmax.|Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24.|PK/PD Substudy Analysis Set (treatment-naive only)||hours|||Number
697721|NCT01363011|Secondary|Plasma Pharmacokinetics of COBI: Ctau (Cohort 2)|Ctau was analyzed for Cohort 2 (treatment-experienced) and was defined as the observed drug concentration at the end of the dosing interval.|Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24.|Participants in the PK/PD Substudy Analysis Set (treatment-experienced only) with available postbaseline data were analyzed.||ng/mL||Standard Deviation|Mean
697722|NCT01363011|Secondary|Plasma Pharmacokinetics of COBI: Ctau (Cohort 1)|Ctau was analyzed for Cohort 1 (treatment-naive) and was defined as the observed drug concentration at the end of the dosing interval.|Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24.|PK/PD Substudy Analysis Set (treatment-naive only)||ng/mL|||Number
697723|NCT01363011|Secondary|Plasma Pharmacokinetics of COBI: Cmax (Cohort 2)|Cmax was analyzed for Cohort 2 (treatment-experienced) and was defined as the maximum observed concentration of drug in plasma.|Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24.|Participants in the PK/PD Substudy Analysis Set (treatment-experienced only) with available postbaseline data were analyzed.||ng/mL||Standard Deviation|Mean
697724|NCT01363011|Secondary|Plasma Pharmacokinetics of COBI: Cmax (Cohort 1)|Cmax was analyzed for Cohort 1 (treatment-naive) and was defined as the maximum observed concentration of drug in plasma.|Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24.|PK/PD Substudy Analysis Set (treatment-naive only)||ng/mL|||Number
697725|NCT01363011|Secondary|Plasma Pharmacokinetics of COBI: AUCtau (Cohort 2)|AUCtau was analyzed for Cohort 2 (treatment-experienced) and was defined as the concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval).|Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24.|Participants in the PK/PD Substudy Analysis Set (treatment-experienced only) with available postbaseline data were analyzed.||h*ng/mL||Standard Deviation|Mean
697726|NCT01363011|Secondary|Plasma Pharmacokinetics of COBI: AUCtau (Cohort 1)|AUCtau was analyzed for Cohort 1 (treatment-naive) and was defined as the concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval).|Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24.|PK/PD Substudy Analysis Set (treatment-naive only)||h*ng/mL|||Number
697727|NCT01363011|Secondary|Percentage of Participants Who Experienced Graded Laboratory Abnormalities (Cohort 2)|Laboratory abnormalities were summarized for Cohort 2 (treatment-experienced) and were defined as values that increased at least one toxicity grade from baseline at any time postbaseline up to and including the date of last dose of study drug plus 30 days. A participant was counted once if they had a qualifying event.|Up to 166 weeks plus 30 days|Treatment-experienced participants in the Safety Analysis Set with available data were analyzed.||percentage of participants|||Number
697728|NCT01363011|Secondary|Percentage of Participants Who Experienced Graded Laboratory Abnormalities (Cohort 1)|Laboratory abnormalities were summarized for Cohort 1 (treatment-naive) and were defined as values that increased at least one toxicity grade from baseline at any time postbaseline up to and including the date of last dose of study drug plus 30 days. A participant was counted once if they had a qualifying event.|Up to 147 weeks plus 30 days|Safety Analysis Set (treatment-naive only)||percentage of participants|||Number
697729|NCT01363011|Secondary|Percentage of Participants Who Experienced Adverse Events (Cohort 2)|Adverse events (AEs) occurring from baseline up to 30 days following the last dose of study drug were summarized for Cohort 2 (treatment-experienced). A participant was counted once if they had a qualifying event.|Up to 166 weeks plus 30 days|Safety Analysis Set (treatment-experienced only)||percentage of participants|||Number
697730|NCT01363011|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 (Cohort 2)|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed in Cohort 2 (treatment-experienced) using the FDA snapshot analysis algorithm.|Week 24|Full Analysis Set (treatment-experienced only): participants in the treatment-experienced group who were randomized and received at least one dose of study drug||percentage of participants|||Number
697732|NCT01363011|Primary|Change From Baseline in aGFR at Weeks 2, 4, and 24 (Cohort 2)|Change from baseline in aGFR at Weeks 2, 4, and 24 was analyzed in Cohort 2 (treatment-experienced). aGFR was calculated using iohexol plasma clearance.|Baseline; Weeks 2, 4, and 24|PK/PD Substudy Analysis Set (treatment-experienced only): participants in the treatment-experienced group who were enrolled and received at least one dose of study drug and who had data for steady-state PK parameters at the relevant time points were analyzed.||mL/min||Inter-Quartile Range|Median
697733|NCT01363011|Primary|Change From Baseline in Actual Glomerular Filtration Rate (aGFR) at Weeks 2, 4, and 24 (Cohort 1)|Change from baseline in aGFR at Weeks 2, 4, and 24 was analyzed in Cohort 1 (treatment-naive). aGFR was calculated using iohexol plasma clearance.|Baseline; Weeks 2, 4, and 24|Pharmacokinetic/Pharmacodynamic (PK/PD) Substudy Analysis Set (treatment-naive only): participants in the treatment-naive group who were enrolled and received at least one dose of study drug and who had data for steady-state PK parameters at the relevant time points were analyzed.||mL/min|||Number
697734|NCT01363011|Primary|Change From Baseline in eGFR-CKD-EPI Based on Cystatin C Equation, Adjusted at Week 24 (Cohort 2)|Change from baseline in eGFR-CKD-EPI based on cystatin C equation (adjusted for age, sex, and race) at Week 24 was analyzed in Cohort 2 (treatment-experienced). The calculation was normalized to 1.73 m^2 body surface area.|Baseline; Week 24|Treatment-experienced participants in the Safety Analysis Set with available data were analyzed.||mL/min/1.73 m^2||Inter-Quartile Range|Median
697735|NCT01363011|Primary|Change From Baseline in eGFR-CKD-EPI Based on Cystatin C Equation, Adjusted at Week 24 (Cohort 1)|Change from baseline in eGFR-CKD-EPI based on cystatin C equation (adjusted for age, sex, and race) at Week 24 was analyzed in Cohort 1 (treatment-naive). The calculation was normalized to 1.73 m^2 body surface area.|Baseline; Week 24|Treatment-naive participants in the Safety Analysis Set with available data were analyzed.||mL/min/1.73 m^2||Inter-Quartile Range|Median
697736|NCT01363011|Secondary|Percentage of Participants Who Experienced Adverse Events (Cohort 1)|Adverse events (AEs) occurring from baseline up to 30 days following the last dose of study drug were summarized for Cohort 1 (treatment-naive). A participant was counted once if they had a qualifying event.|Up to 147 weeks plus 30 days|Safety Analysis Set (treatment-naive only)||percentage of participants|||Number
697737|NCT01363011|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 48 and 96 (Cohort 2)|The percentage of participants with HIV-1 RNA < 50 copies/mL at Weeks 48 and 96 were analyzed in Cohort 2 (treatment-experienced) using the FDA snapshot analysis algorithm.|Weeks 48 and 96|Treatment-experienced participants in the Full Analysis Set with available data were analyzed.||percentage of participants|||Number
697738|NCT01363011|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 48 and 96 (Cohort 1)|The percentage of participants with HIV-1 RNA < 50 copies/mL at Weeks 48 and 96 were analyzed in Cohort 1 (treatment-naive) using the FDA snapshot analysis algorithm.|Weeks 48 and 96|Treatment-naive participants in the Full Analysis Set with available data was analyzed.||percentage of participants|||Number
697739|NCT01363011|Secondary|Change From Baseline in eGFR-CKD-EPI Based on Cystatin C Equation (Adjusted) at Weeks 48 and 96 (Cohort 2)|Change from baseline in eGFR-CKD-EPI based on cystatin C equation (adjusted for age, sex, and race) at Weeks 48 and 96 were analyzed in Cohort 2 (treatment-experienced). The calculation was normalized to 1.73 m^2 body surface area. This outcome is to measure the long-term effect of COBI-containing regimens on renal parameters.|Baseline; Weeks 48 and 96|Treatment-experienced participants in the Safety Analysis Set with available data were analyzed.||mL/min/1.73 m^2||Inter-Quartile Range|Median
697740|NCT01363011|Secondary|Change From Baseline in eGFR-CKD-EPI Based on Cystatin C Equation (Adjusted) at Weeks 48 and 96 (Cohort 1)|Change from baseline in eGFR-CKD-EPI based on cystatin C equation (adjusted for age, sex, and race) at Weeks 48 and 96 were analyzed in Cohort 1 (treatment-naive). The calculation was normalized to 1.73 m^2 body surface area. This outcome is to measure the long-term effect of COBI-containing regimens on renal parameters.|Baseline; Weeks 48 and 96|Treatment-naive participants in the Safety Analysis Set with available data were analyzed.||mL/min/1.73 m^2||Inter-Quartile Range|Median
697741|NCT01363011|Primary|Change From Baseline in eGFR-CKD-EPI Formula Based on Cystatin C Equation at Week 24 (Cohort 2)|Change from baseline in eGFR-CKD-EPI based on cystatin C equation (not adjusted for age, sex, and race) at Week 24 was analyzed in Cohort 2 (treatment-experienced). The calculation was normalized to 1.73 m^2 body surface area.|Baseline; Week 24|Treatment-experienced participants in the Safety Analysis Set with available data were analyzed.||mL/min/1.73 m^2||Inter-Quartile Range|Median
697742|NCT01363011|Primary|Change From Baseline in eGFR Using the Chronic Kidney Disease, Epidemiology Collaboration (CKD-EPI) Formula Based on Cystatin C Equation at Week 24 (Cohort 1)|Change from baseline in eGFR-CKD-EPI based on cystatin C equation (not adjusted for age, sex, and race) at Week 24 was analyzed in Cohort 1 (treatment-naive). The calculation was normalized to 1.73 m^2 body surface area.|Baseline; Week 24|Treatment-naive participants in the Safety Analysis Set with available data were analyzed.||mL/min/1.73 m^2||Inter-Quartile Range|Median
697743|NCT01363011|Primary|Change From Baseline in eGFR-MDRD at Week 24 (Cohort 2)|Change from baseline in eGFR-MDRD equation at Week 24 was analyzed in Cohort 2 (treatment-experienced). The calculation was normalized to 1.73 m^2 body surface area.|Baseline; Week 24|Treatment-experienced participants in the Safety Analysis Set with available data were analyzed.||mL/min/1.73 m^2||Inter-Quartile Range|Median
697744|NCT01363011|Primary|Change From Baseline in eGFR Using the Modification of Diet in Renal (MDRD) Equation at Week 24 (Cohort 1)|Change from baseline in eGFR-MDRD equation at Week 24 was analyzed in Cohort 1 (treatment-naive). The calculation was normalized to 1.73 m^2 body surface area.|Baseline; Week 24|Treatment-naive participants in the Safety Analysis Set with available data were analyzed.||mL/min/1.73 m^2||Inter-Quartile Range|Median
697745|NCT01363011|Secondary|Change From Baseline in eGFR-CKD-EPI Based on Cystatin C Equation at Weeks 48 and 96 (Cohort 2)|Change from baseline in eGFR-CKD-EPI based on cystatin C equation (not adjusted for age, sex, and race) at Weeks 48 and 96 were analyzed in Cohort 2 (treatment-experienced). The calculation was normalized to 1.73 m^2 body surface area. This outcome is to measure the long-term effect of COBI-containing regimens on renal parameters.|Baseline; Weeks 48 and 96|Treatment-experienced participants in the Safety Analysis Set with available data were analyzed.||mL/min/1.73 m^2||Inter-Quartile Range|Median
698038|NCT01361113|Secondary|Predictive Molecular Markers in Response to Treatment With Pazopanib|To assess the correlation between the expression of biomarkers and CT scan response. Patients are considered as responders when objective response (partial or complete response) is shown on CT scan and measured by RECIST version 1.1|1 year||||||
697746|NCT01363011|Secondary|Change From Baseline in eGFR-CKD-EPI Based on Cystatin C Equation at Weeks 48 and 96 (Cohort 1)|Change from baseline in eGFR-CKD-EPI based on cystatin C equation (not adjusted for age, sex, and race) at Weeks 48 and 96 were analyzed in Cohort 1 (treatment-naive). The calculation was normalized to 1.73 m^2 body surface area. This outcome is to measure the long-term effect of COBI-containing regimens on renal parameters.|Baseline; Weeks 48 and 96|Treatment-naive participants in the Safety Analysis Set with available data were analyzed.||mL/min/1.73 m^2||Inter-Quartile Range|Median
697747|NCT01363011|Secondary|Change From Baseline in eGFR-MDRD at Weeks 48 and 96 (Cohort 2)|Change from baseline in eGFR-MDRD at Weeks 48 and 96 were analyzed in Cohort 2 (treatment-experienced). The calculation was normalized to 1.73 m^2 body surface area. This outcome is to measure the long-term effect of COBI-containing regimens on renal parameters.|Baseline; Weeks 48 and 96|Treatment-experienced participants in the Safety Analysis Set with available data were analyzed.||mL/min/1.73 m^2||Inter-Quartile Range|Median
697748|NCT01363011|Secondary|Change From Baseline in eGFR-MDRD at Weeks 48 and 96 (Cohort 1)|Change from baseline in eGFR-MDRD at Weeks 48 and 96 were analyzed in Cohort 1 (treatment-naive). The calculation was normalized to 1.73 m^2 body surface area. This outcome is to measure the long-term effect of COBI-containing regimens on renal parameters.|Baseline; Weeks 48 and 96|Treatment-naive participants in the Safety Analysis Set with available data were analyzed.||mL/min/1.73 m^2||Inter-Quartile Range|Median
697749|NCT01363011|Secondary|Change From Baseline in eGFR-CG at Weeks 48 and 96 (Cohort 2)|Change from baseline in eGFR-CG at Weeks 48 and 96 were analyzed in Cohort 2 (treatment-experienced). This outcome is to measure the long-term effect of COBI-containing regimens on renal parameters.|Baseline; Week 48|Participants in the Safety Analysis Set (treatment-experienced only) with available data were analyzed.||mL/min||Inter-Quartile Range|Median
697750|NCT01363011|Secondary|Change From Baseline in eGFR-CG at Weeks 48 and 96 (Cohort 1)|Change from baseline in eGFR-CG at Weeks 48 and 96 were analyzed in Cohort 1 (treatment-naive). This outcome is to measure the long-term effect of COBI-containing regimens on renal parameters.|Baseline; Weeks 48 and 96|Treatment-naive participants in the Safety Analysis Set with available data were analyzed.||mL/min||Inter-Quartile Range|Median
697751|NCT01363011|Primary|Change From Baseline in eGFR-CG at Week 24 (Cohort 2)|Change from baseline in eGFR-CG equation at Week 24 was analyzed in Cohort 2 (treatment-experienced).|Baseline; Week 24|Safety Analysis Set (treatment-experienced only): participants in the treatment-experienced group who were randomized and received at least one dose of study drug||mL/min||Inter-Quartile Range|Median
697752|NCT01363011|Primary|Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) Using the Cockcroft-Gault (CG) Equation at Week 24 (Cohort 1)|Change from baseline in eGFR-CG equation at Week 24 was analyzed in Cohort 1 (treatment-naive).|Baseline; Week 24|Safety Analysis Set (treatment-naive only): participants in the treatment-naive group who were randomized and received at least one dose of study drug||mL/min||Inter-Quartile Range|Median
697753|NCT01362946|Secondary|Overall Treatment Recommendation - Parent|At end end of both treatment blocks, parents selected which treatment they though was best for their child - standard behavioral treatment or modified behavioral treatment|End of all treatment, at week 8|Four children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria). One excluded because only completed one block of treatment.||percentage of participants|||Number
697754|NCT01362946|Secondary|Overall Treatment Recommendation - Counselor|At end end of both treatment blocks, counselors sorted children into one of four treatment response groups: (1) responded best to standard behavior therapy; (2) responded best to modified behavior therapy; (3) responded well to both treatments; (4) did not respond to either treatment|End of all treatment, at week 8|Four children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria). One excluded because only completed one block of treatment.||percentage of participants|||Number
697755|NCT01362946|Secondary|Overall Effectiveness|"At the end of each treatment block parents rated their overall satisfaction with the treatment provided to their child. This item was phrased as follows: Please rate how effective this treatment was in changing your child as compared with other treatment services your child has received. This item was rated using a Likert scale that ranged from 0 (this treatment much less effective) to 4 (this treatment much more effective)."|End of each treatment, at weeks 4 and 8|Four children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria). One was excluded because parent did not return completed ratings.||units on a scale||Standard Error|Least Squares Mean
697756|NCT01362946|Secondary|Overall Satisfaction|"At the end of each treatment block parents rated their overall satisfaction with the treatment provided to their child. This item was phrased as follows: Please rate your overall satisfaction with this treatment as compared with other treatment services your child has received. This item was rated using a Likert scale that ranged from 0 (much less satisfied with this program) to 4 (much more satisfied with this program)."|End of each treatment, at weeks 4 and 8|Four children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria). One was excluded because parent did not return completed ratings.||units on a scale||Standard Error|Least Squares Mean
697757|NCT01362946|Secondary|Recommend Treatment?|"At the end of each treatment block parents rated their overall satisfaction with the treatment provided to their child. This item was phrased as follows: Would you recommend this treatment to other parents?. This item was rated using a Likert scale that ranged from 0 (no definitely) to 4 (yes definitely)."|End of each treatment, at weeks 4 and 8|Four children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria). One was excluded because parent did not return completed ratings.||units on a scale||Standard Error|Least Squares Mean
698164|NCT01359748|Primary|BP Measurements Using the Reference Auscultatory Sphygmomanometer|"The subject was measured by the two observers at the same time using the reference sphygmomanometer and double stethoscope.
The observers agree to take the K5 korotkoff sound. Each observer takes notes of their own measures."|Five minutes|||mmHg||Standard Deviation|Mean
697758|NCT01362946|Secondary|Would You Send Your Child to This Treatment Again?|"At the end of each treatment block parents rated their overall satisfaction with the treatment provided to their child. This item was phrased as follows: Would you send your child to this treatment if you could do it over again?. This item was rated using a Likert scale that ranged from 0 (no definitely) to 4 (yes definitely)."|End of each treatment, at weeks 4 and 8|Four children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria). One was excluded because parent did not return completed ratings.||units on a scale||Standard Error|Least Squares Mean
697759|NCT01362946|Secondary|How Much Did Your Child Enjoy the Treatment?|"At the end of each treatment block parents rated their overall satisfaction with the treatment provided to their child. This item was phrased as follows: How much did your child this treatment?. This item was rated using a Likert scale that ranged from 0 (not at all) to 3 (very much)."|End of each treatment, at weeks 4 and 8|Four children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria). One was excluded because parent did not return completed ratings.||units on a scale||Standard Error|Least Squares Mean
697760|NCT01362946|Secondary|How Much Did You (the Parent) Benefit From Treatment?|"At the end of each treatment block parents rated their overall satisfaction with the treatment provided to their child. This item was phrased as follows: How much did you benefit from this treatment?. This item was rated using a Likert scale that ranged from 0 (not at all) to 3 (very much)."|End of each treatment, at weeks 4 and 8|Four children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria). One was excluded because parent did not return completed ratings.||units on a scale||Standard Error|Least Squares Mean
697761|NCT01362946|Secondary|How Much Did Your Child Benefit From Treatment?|"At the end of each treatment block parents rated their overall satisfaction with the treatment provided to their child. This item was phrased as follows: How much did your child benefit from this treatment?. This item was rated using a Likert scale that ranged from 0 (not at all) to 3 (very much)."|End of each treatment, at weeks 4 and 8|Four children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria). One was excluded because parent did not return completed ratings.||units on a scale||Standard Error|Least Squares Mean
697762|NCT01362946|Secondary|WPRF Overall Problems - Parent|"At the end of each treatment week parents rated each child's overall problems during the week. Rating were completed on the Weekly Problem Rating Form (Haas et al, 2011) using Likert scales that ranged from 1 (no problem) to 7 (serious problem). Items were averaged to compute a scale score with a theoretical range of 1 to 7, with high scores indicating more serious problems."|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).||units on a scale||Standard Error|Least Squares Mean
697763|NCT01362946|Secondary|WPRF Overall Problems - Counselor|"At the end of each treatment week counselors rated each child's overall problems during the week. Rating were completed on the Weekly Problem Rating Form (Haas et al, 2011) using Likert scales that ranged from 1 (no problem) to 7 (serious problem). Items were averaged to compute a scale score with a theoretical range of 1 to 7, with high scores indicating more serious problems."|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).||units on a scale||Standard Error|Least Squares Mean
697764|NCT01362946|Secondary|WPRF Rule Following Problems - Parent|"At the end of each treatment week parents rated each child's rule following problems during the week. Rating were completed on the Weekly Problem Rating Form (Haas et al, 2011) using Likert scales that ranged from 1 (no problem) to 7 (serious problem). Items were averaged to compute a scale score with a theoretical range of 1 to 7, with high scores indicating more serious problems."|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).||units on a scale||Standard Error|Least Squares Mean
697765|NCT01362946|Secondary|WPRF Rule Following Problems - Counselor|"At the end of each treatment week counselors rated each child's rule following problems during the week. Rating were completed on the Weekly Problem Rating Form (Haas et al, 2011) using Likert scales that ranged from 1 (no problem) to 7 (serious problem). Items were averaged to compute a scale score with a theoretical range of 1 to 7, with high scores indicating more serious problems."|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).||units on a scale||Standard Error|Least Squares Mean
697766|NCT01362946|Secondary|WPRF Serious Conduct Problems Scale - Parent|"At the end of each treatment week parents rated each child's serious conduct problems during the week. Rating were completed on the Weekly Problem Rating Form (Haas et al, 2011) using Likert scales that ranged from 1 (no problem) to 7 (serious problem). Items were averaged to compute a scale score with a theoretical range of 1 to 7, with high scores indicating more serious problems."|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).||units on a scale||Standard Error|Least Squares Mean
697767|NCT01362946|Secondary|WPRF Serious Conduct Problems Scale - Counselor|"At the end of each treatment week counselors rated each child's serious conduct problems during the week. Rating were completed on the Weekly Problem Rating Form (Haas et al, 2011) using Likert scales that ranged from 1 (no problem) to 7 (serious problem). Items were averaged to compute a scale score with a theoretical range of 1 to 7, with high scores indicating more serious problems."|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).||units on a scale||Standard Error|Least Squares Mean
697768|NCT01362946|Secondary|IOWA Oppositional-defiant Scale - Parent|"At the end of each treatment week parents rated each child's overall oppositional-defiant behavior during the week. Rating were completed using Likert scales that ranged from 0 (not at all) to 3 (very much). Items were summed to compute a scale score with a theoretical range of 0 to 15."|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).||units on a scale||Standard Error|Least Squares Mean
697769|NCT01362946|Secondary|IOWA Oppositional-defiant Scale - Counselor|"At the end of each treatment week counselors rated each child's overall oppositional-defiant behavior during the week. Rating were completed using Likert scales that ranged from 0 (not at all) to 3 (very much). Items were summed to compute a scale score with a theoretical range of 0 to 15."|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).||units on a scale||Standard Error|Least Squares Mean
697770|NCT01362946|Secondary|IOWA Inattentive/Overactive Scale - Parent|"At the end of each treatment week parents rated each child's overall inattentive-overactive-impulsive behavior during the week. Rating were completed using Likert scales that ranged from 0 (not at all) to 3 (very much). Items were summed to compute a scale score with a theoretical range of 0 to 15."|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).||units on a scale||Standard Error|Least Squares Mean
697771|NCT01362946|Primary|Minutes of Physical Management|Counselors recorded the total number of minutes children had to be physically managed due to behavior dangerous to themselves or others. The average number per day was computed for each week of treatment.|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).||Minutes of Physical Manage per day||Standard Error|Least Squares Mean
697772|NCT01362946|Primary|Number of Time Outs|Counselors recorded the total number of Time Outs children served due to intentional aggression, intentional destruction of property, or repeated noncompliance. The average number per day was computed for each week of treatment.|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).||Number of Time Outs per day||Standard Error|Least Squares Mean
697773|NCT01362946|Primary|Minutes in Time Out|Counselors recorded the total number of minutes children were in Time Out due to intentional aggression, intentional destruction of property, or repeated noncompliance. The average number per day was computed for each week of treatment.|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).||Minutes in Time Out per day||Standard Error|Least Squares Mean
697774|NCT01362946|Primary|Positive Peer Behavior|Counselors recorded each instance of positive behavior with peers, defined as helping, sharing and ignoring teasing. The average number per day was computed for each week of treatment.|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).||Number of positive peer behave per day||Standard Error|Least Squares Mean
697775|NCT01362946|Primary|Rule Violations|Counselors recorded each instance of rule violations. The average number per day was computed for each week of treatment.|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).||Number of rule violations per day||Standard Error|Least Squares Mean
697776|NCT01362946|Primary|Noncompliance|Counselors recorded each instance of noncompliance. The average number per day was computed for each week of treatment.|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).||Number of noncompliance per day||Standard Error|Least Squares Mean
697777|NCT01362946|Primary|Interruption|Counselors recorded each instance of interrupting. The average number per day was computed for each week of treatment.|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).||Number of interruptions per day||Standard Error|Least Squares Mean
697778|NCT01362946|Primary|Complaining|Counselors recorded each instance of complaining. The average number per day was computed for each week of treatment.|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).||Number of complaints per day||Standard Error|Least Squares Mean
697779|NCT01362946|Primary|Negative Verbalizations|Counselors recorded each instance of negative verbalizations, defined as verbal abuse to staff, teasing peers, and swearing. The average number per day was computed for each week of treatment.|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).||Number of negative verbals per day||Standard Error|Least Squares Mean
697780|NCT01362946|Secondary|IOWA Inattentive/Overactive Scale - Counselor|"At the end of each treatment week counselors rated each child's overall inattentive-overactive-impulsive behavior during the week. Rating were completed using Likert scales that ranged from 0 (not at all) to 3 (very much). Items were summed to compute a scale score with a theoretical range of 0 to 15."|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).||units on a scale||Standard Error|Least Squares Mean
727503|NCT00376168|Secondary|Change in Hemoglobin|Absolute change in Hemoglobin concentration from Baseline to Month 9|Baseline and Month 9|Intent to treat||g/dL||Standard Deviation|Mean
697781|NCT01362946|Primary|Conduct Problems|Counselors recorded each instance of conduct problems, defined as lying, stealing, intentional destruction of property, and intentional aggression. The average number per day was computed for each week of treatment.|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).||Number of conduct problems per day||Standard Error|Least Squares Mean
697782|NCT01362907|Secondary|Overall Lens Fit|As assessed for each eye individually by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit is reported on a 5-point scale, with 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight.|1 week of wear, replacing lenses daily|All enrolled and dispensed participants.||Units on a scale|Participants|Standard Deviation|Mean
697783|NCT01362907|Primary|Overall Handling|As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall handling was evaluated binocularly and rated on a 10-point scale, with 1 being difficult and 10 being easy.|1 week of wear, replacing lenses daily|All enrolled and dispensed participants.||Units on a scale||Standard Deviation|Mean
697784|NCT01362907|Primary|Overall Vision Quality|As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision quality was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.|1 week of wear, replacing lenses daily|All enrolled and dispensed participants.||Units on a scale||Standard Deviation|Mean
697785|NCT01362907|Primary|Overall Comfort|As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.|1 week of wear, replacing lenses daily|All enrolled and dispensed participants.||Units on a scale||Standard Deviation|Mean
697786|NCT01362907|Primary|Corrected Distance Monocular Visual Measurement Reported as Visual Acuity (VA)|As tested for each eye individually while wearing study lenses. VA was measured using a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equated to a logMAR acuity of 0.0 and was considered normal distance eyesight. Positive logMAR values indicated poorer vision, and negative values denoted better visual acuity.|1 week of wear, replacing lenses daily|All enrolled and dispensed participants.||logMAR|Participants|Standard Deviation|Mean
697787|NCT01362894|Secondary|Ease of Selecting Final Lens Power|As interpreted by the investigator at time of lens fitting and recorded on a questionnaire. Ease of selecting final lens power was rated on a 10-point scale, with 1 being difficult and 10 being easy.|Day 0|The Efficacy Evaluable Set (EES) contained all enrolled and dispensed subjects with no major protocol deviations as determined by masked review that also completed a minimum of 4 days of lens wear with either study product and attended an assessing follow-up visit.||Units on a scale||Standard Deviation|Mean
697788|NCT01362894|Primary|Overall Satisfaction|As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision was rated on a 10-point scale, with 1 being poor and 10 being excellent.|1 week, replacing lenses daily|The Efficacy Evaluable Set (EES) contained all enrolled and dispensed subjects with no major protocol deviations as determined by masked review that also completed a minimum of 4 days of lens wear with either study product and attended an assessing follow-up visit.||Units on a scale||Standard Deviation|Mean
697789|NCT01362894|Primary|Overall Handling|As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall handling was rated on a 10-point scale, with 1 being difficult and 10 being easy.|1 week, replacing lenses daily|The Efficacy Evaluable Set (EES) contained all enrolled and dispensed subjects with no major protocol deviations as determined by masked review that also completed a minimum of 4 days of lens wear with either study product and attended an assessing follow-up visit.||Units on a scale||Standard Deviation|Mean
697790|NCT01362894|Primary|Overall Comfort|As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall comfort was rated on a 10-point scale, with 1 being poor and 10 being excellent.|1 week, replacing lenses daily|The Efficacy Evaluable Set (EES) contained all enrolled and dispensed subjects with no major protocol deviations as determined by masked review that also completed a minimum of 4 days of lens wear with either study product and attended an assessing follow-up visit.||Units on a scale||Standard Deviation|Mean
697791|NCT01362894|Primary|Overall Vision|As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision was rated on a 10-point scale, with 1 being poor and 10 being excellent.|1 week, replacing lenses daily|The Efficacy Evaluable Set (EES) contained all enrolled and dispensed subjects with no major protocol deviations as determined by masked review that also completed a minimum of 4 days of lens wear with either study product and attended an assessing follow-up visit.||Units on a scale||Standard Deviation|Mean
697792|NCT01362686|Secondary|Healthy Aging Brain Care (HABC)-Monitor|The current HABC-Monitor includes 30 items covering four clinically relevant domains of dementia, ie, cognitive, functional, behavioral, and psychological symptoms, and caregiver quality of life. For brevity and practical use in the clinical setting, each item on the four scales was designed to have the same item response options consisting of four categories that use the frequency of the target problem in the past 2 weeks. The HABC- Monitor took approximately 6 minutes to complete. The scores of the four scales are summed to create the total scores which were used in this analysis.The higher the total score, the higher the level of self reported caregiver burden. The minimum score is 0 and the maximum score is 90.|baseline, 6, 12, and 18 week interviews|||units on a scale||Standard Deviation|Mean
697812|NCT01362530|Secondary|Percentage of Participants With a Complete Response in the Overall Phase of Cycle 1|Overall phase was defined as 0 to 120 hourse after the start of chemotherapy. Complete response was defined as no vomiting or retching and no use of rescue medication in the overall phase of Cycle 1.|0 to 120 hours after initiation of chemotherapy|ITT population: all randomized participants who received study medication. Results for Cycles 2-6 were not included because this outcome measure is for Cycle 1 only.||Percentage of participants|||Number
699171|NCT01347840|Secondary|Area Under the Curve of Timed Gastrointestinal Hormones (Insulin, GIP, Pancreatic Polypeptide, Peptide YY (PYY), Amylin, Glucagon, Pro-Insulin, C-Peptide)|These variables will measure the combined effects of hormone concentration and duration.|16 months|||units on a scale|||Number
697793|NCT01362686|Secondary|Neuropsychiatric Inventory (NPI)|The NPI is based on a structured interview administered to an informal caregiver and has been adopted by the Alzheimer’s Disease Cooperative Studies Group to obtain information on the presence of psychopathology in behavioral areas including delusions, apathy, hallucinations, disinhibition, agitation, depression, aberrant motor behavior, anxiety, night-time behavior, and euphoria.9 For each of 12 symptoms, if the caregiver reports the presence of psychopathology, a frequency and severity score are multiplied to yield a possible item score range of 0–12, and a possible total score range of 0–144. The NPI can be used to assess changes in the patient’s behavior over the past month. The NPI also assesses the level of caregiver distress attributable to each of the 12 patient behaviors, with a possible total caregiver distress score range of 0–60. Higher scores indicate higher severity of psychopathology and caregiver disress. The NPI has excellent reliability and validity.|Baseline, 6, 12, 18 week interviews from enrollment|||units on a scale||Standard Deviation|Mean
697794|NCT01362686|Primary|Discontinuation Rates|We are not seeking to establish efficacy of these three medications for the indication of Alzheimer’s disease. Each of these medications already has FDA-approval for Alzheimer’s. The primary outcome measure is the discontinuation rate among the three medications. Based on previous systematic reviews, these rates are reportedly in the range of 30% by 12 weeks compared with placebo. We will determine the approximate date of discontinuation by self-reports from the caregiver through the telephone-based interview at 6, 12, and 18 weeks.|6, 12, and 18 week interviews from enrollment|||participants|||Number
697795|NCT01362608|Secondary|High Sensitivity C-reactive Protein [hsCRP] Measured in the Serum at 72 Hours Post Dose||72 hours post dose|||mg/L||95% Confidence Interval|Mean
697796|NCT01362608|Secondary|Amount of Rescue Medication Taken at Baseline Flare and Post Baseline Flare.|Paracetamol / acetaminophen, Prednisolone and Prednisone taken at baseline flare and post baseline flare.|12 weeks|FAS||mg||Standard Deviation|Mean
697797|NCT01362608|Secondary|Percent Patients Who Took Rescue Medication||12 weeks|FAS||percentage|||Number
697798|NCT01362608|Secondary|Time to First Rescue Medication Intake||12 weeks|FAS||hours||Standard Deviation|Mean
697799|NCT01362608|Secondary|Time to Complete Resolution of Pain: Survival Analysis by Treatment|Kaplan Meier estimate|12 weeks|Full analysis set||hours||95% Confidence Interval|Median
697800|NCT01362608|Secondary|Time to at Least a 50% Reduction in Baseline Pain Intensity: Survival Analysis by Treatment|Kaplan Meier estimate|12 weeks|Full analysis set||hours||95% Confidence Interval|Median
697801|NCT01362608|Secondary|Physician’s Assessment of Range of Motion: Frequency Table by Timepoint and Treatment|Physicians will score their response ofrange of motion on a 5-point Likert scale (normal,mildly restricted, moderately restricted, severely restricted and immolbilized).|baseline through week 12|Full Analysis Set||participants|||Number
697802|NCT01362608|Secondary|Physician’s Assessment of Erythema: Frequency Table by Timepoint and Treatment|Physicians will score their response of erythema on a 4-point Likert scale (absent, present not assessed and not assessable).|baseline 72 hours,7 days 4 weeks, 8 weeks and 12 weeks post dose|Full analysis set||participants|||Number
697803|NCT01362608|Secondary|Physician’s Assessment of Swelling: Frequency Table by Timepoint and Treatment|Physicians will score their response to pain on a 5-point Likert scale (no pain, pain,pain and winces,pain winces and withdraws and not assessed).|baseline 72 hours,7 days 4 weeks, 8 weeks and 12 weeks post dose|Full analysis set||participants|||Number
697804|NCT01362608|Secondary|Physician’s Assessment of Tenderness: Frequency Table by Timepoint and Treatment|Physicians will score their response to pain on a 5-point Likert scale (no pain, pain,pain and winces,pain winces and withdraws and not assessed).|baseline 72 hours,7 days 4 weeks, 8 weeks and 12 weeks post dose|Full analysis set||participants|||Number
697805|NCT01362608|Secondary|Patient’s Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale.|Patients will score their response to pain on a 7-point Likert scale (excellent, good ,acceptable, slight,poor,very poor,not done).|72 hours through week 12|Full Analysis Set||participants|||Number
697806|NCT01362608|Secondary|Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment|Patients will score their current pain intensity in the most affected joint of the gout flare on a 5-point Likert scale (none, mild, moderate, severe, extreme).|baseline through week 12|Full Analysis Set||participants|||Number
697807|NCT01362608|Secondary|Patients Assessment of Gout Pain Intensity in the Most Effected Joint (0–100mm VAS): Summary Statistics by Timepoint and Treatment|A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in postsurgical patients (knee replacement, hysterectomy, or laparoscopic myomectomy) who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0 – 4 mm), mild pain (5– 44 mm), moderate pain (45–74 mm), and severe pain (75– 100 mm)|baseline through 12 weeks|Full Analysis set||unit on a scale||Standard Deviation|Mean
697808|NCT01362608|Secondary|The Number of Patients With at Least 1 New Gout Flare||12 weeks|||participants|||Number
697809|NCT01362608|Primary|Time to First New Flare: Survival Analysis by Treatment: Kaplan Meier Analysis|Measure canakinumab 150 mg s.c. is superior to triamcinolone acetonide 40 mg i.m. with respect to the time to the first new gout flare in observation period of 12 weeks|12 weeks|Full Analysis Set||Participants||95% Confidence Interval|Number
697810|NCT01362608|Primary|The Change in the Gout Pain Intensity in the Target Joint Following ACZ885 Administration Measured by Visual Analog Scale (VAS)|A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in postsurgical patients (knee replacement, hysterectomy, or laparoscopic myomectomy) who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0 – 4 mm), mild pain (5– 44 mm), moderate pain (45–74 mm), and severe pain (75– 100 mm)|at 72 hours post-dose|Full Analysis set||units on a scale||Standard Error|Least Squares Mean
697811|NCT01362530|Secondary|Percentage of Participants With No Vomiting in the Overall Phase of Cycle 1|Overall phase was defined as 0 to 120 hourse after the start of chemotherapy. No vomiting was defined as no emesis or retching or dry heaves in the overall phase of Cycle 1.|0 to 120 hours after initiation of chemotherapy|ITT population: all randomized participants who received study medication. Results for Cycles 2-6 were not included because this outcome measure is for Cycle 1 only.||Percentage of participants|||Number
697813|NCT01362530|Secondary|Percentage of Participants With a Complete Response in the Acute Phase of Cycle 1|Acute phase was defined as 0 to 24 hours after the start of chemotherapy. Complete response was defined as no vomiting or retching and no use of rescue medication in the acute phase of Cycle 1.|0 to 24 hours after initiation of chemotherapy|ITT population: all randomized participants who received study medication. Results for Cycles 2-6 were not included because this outcome measure is for Cycle 1 only.||Percentage of participants|||Number
697814|NCT01362530|Primary|Percentage of Participants With a Complete Response in the Delayed Phase of Cycle 1|Delayed Phase was defined as 25-120 hours after the start of chemotherapy. Complete response was defined as no vomiting or retching and no use of rescue medication in the delayed phase of Cycle 1.|25 to 120 hours after the start of chemotherapy|Intent-to-treat (ITT) population: all randomized participants who received study medication. Results for Cycles 2-6 were not included because this outcome measure is for Cycle 1 only.||Percentage of participants|||Number
697815|NCT01362517|Secondary|Safety: Adverse and Serious Adverse Events|Assessment of the proportion of children with adverse events and/or serious adverse events following each Quinvaxem vaccine injection|From Day 1 up to 30 days after the third vaccination|||Number of children with AE per 100 doses|Participants||Number
697816|NCT01362517|Primary|Immunogenicity - Seroprotection (Seroconversion for Pertussis) to Each Vaccine Component|Assessment of the proportion of subjects who have seroconverted to each of the 5 vaccine components (D, T, P, HepB, Hib)|at 14 months (equivalent to 12 months after the first vaccination|Analysis population excludes one subject excluded as a protocol violator and additionally at 14 months one lost to follow up||percentage of subjects||95% Confidence Interval|Number
697817|NCT01362517|Primary|Immunogenicity - Seroprotection (Seroconversion for Pertussis) to Each Vaccine Component|Assessment of the proportion of subjects who have seroconverted to each of the 5 vaccine components (D, T, P, HepB, Hib)|at 5 months (equivalent to 1 month after the third vaccination)|Analysis population excludes one subject excluded as a protocol violator||percentage of subjects||95% Confidence Interval|Number
697818|NCT01362491|Secondary|Cumulative Percentage of Participants With Complete Relief|Complete relief was defined as a PRR of 4. PRR was assessed on a 5-point categorical pain relief rating scale where 0=No relief to 4=Complete relief|1, 2, & 3 hours post-dose|ITT population included all randomized participants who received study medication and provided a baseline assessment.||percentage of participants|||Number
697819|NCT01362491|Secondary|Cumulative Percentage of Participants With Treatment Failure|Percentage of participants who withdrew from the study due to lack of efficacy or received rescue medication.|1, 2, 3 hours post-dose|ITT population included all randomized patients who received study medication and provided a baseline assessment.||percentage of participants|||Number
697820|NCT01362491|Secondary|Duration of Relief|Median participant time for dropping out of the study due to lack of efficacy or receipt of rescue medication, whichever came first.|0 to 3 hours|Population included all randomized patients that reported a treatment failure or received rescue medication.|||||
697821|NCT01362491|Secondary|Cumulative Percentage of Participants With First Perceptible Relief|"Percentage of participants with first perceptible relief evaluated by stopping a stopwatch labeled 'first perceptible relief' at the moment the participant first began to experience any relief. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered. First perceptible relief was considered confirmed by meaningful relief if the participant achieved both first perceptible and meaningful relief by either depressing the second stopwatch or by indicating that his/her first perceptible relief was also meaningful."|0.5, 1, 2, 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||percentage of participants|||Number
697822|NCT01362491|Secondary|Cumulative Percentage of Participants With Meaningful Relief|Percentage of participants with meaningful relief evaluated by stopping a second stopwatch labeled ‘meaningful relief' at the moment the participant first began to experience meaningful relief. It was also considered achieved if the participant stated “meaningful relief” at the time the first stopwatch was depressed. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered.|0.5, 1, 2, 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||percentage of participants|||Number
697823|NCT01362491|Secondary|Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID)|SPRID: time-weighted sum of PRID over 2 and 3 hours. SPRID score range was -2(worst) to 14(best) for SPRID 0-2 and -3 (worst) to 21 (best) for SPRID 0-3. PRID: sum of PID and PRR at each time point. Total score range for PRID: -1=worst to 7=best. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderately severe to 3=severe). Total score range for PID: -1(worst) to 3(best), PRR: assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief).|0 to 2, 0 to 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||units on scale||Standard Deviation|Mean
697824|NCT01362491|Secondary|Time-weighted Sum of Pain Relief Rating (TOTPAR)|TOTPAR: time-weighted sum of PRR over 2 and 3 hours. TOTPAR score range was 0 (worst) to 8 (best) for TOTPAR 0-2 and 0 (worst) to 12 (best) for TOTPAR 0-3. PRR was assessed on a 5-point categorical pain relief rating scale wherein 0=No relief to 4=Complete relief.|0 to 2, 0 to 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||units on scale||Standard Deviation|Mean
697825|NCT01362491|Secondary|Time-weighted Sum of Pain Intensity Difference (SPID)|SPID: time-weighted sum of PID over 2 and 3 hours. SPID score range was -2(worst) to 6 (best) for SPID 0-2 and -3 (worst) to 9 (best) for SPID 0-3. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderately severe to 3=severe). Total score range for PID: -1(worst) to 3 (best).|0 to 2, 0 to 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||units on scale||Standard Deviation|Mean
697901|NCT01362244|Secondary|Number of Participants With Positive Clinically Relevant Urinalysis Results at Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Specific gravity, power of hydrogen (pH), glucose, protein, blood, and ketones were assessed at Weeks (Wk) 1, 2, 5, 9, 13, 17, 21, and 25.|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Specific gravity, power of hydrogen (pH), glucose, protein, blood, and ketones were assessed at Weeks 1, 2, 5, 9, 13, 17, 21, and 25. Results for all urinalysis parameters were assessed for clinical relevance.||participants|||Number
697826|NCT01362491|Secondary|Sum of Pain Relief Rating and Pain Intensity Difference (PRID)|PRID was sum of PID and PRR at each post-dosing time point. The overall possible score range, for PRID was -1 (worst) to 7 (best). PID was derived by subtracting the pain severity score at a given post-dosing time point [pain severity score range 0 (none) to 3 (severe)] from the baseline score [Baseline pain severity score range 2 (moderately severe) to 3 (severe)]. Total possible score range for PID: -1 (worst) to 3 (best). PRR was assessed on 5-point categorical pain relief rating scale (0=No relief to 4=Complete relief).|1, 2 & 3 hours post-dose|ITT population included all randomized participants who received study medication and provided a baseline assessment.||units on scale||Standard Deviation|Mean
697827|NCT01362491|Secondary|Pain Intensity Difference (PID)|PID was derived by subtracting the pain severity score at a given post-dosing time point [pain severity score range 0 (none) to 3 (severe)] from the baseline score [Baseline pain severity score range 2 (moderately severe) to 3 (severe)]. Total possible score range for PID: -1 (worst) to 3 (best).|1, 2 & 3 hours post-dose|ITT population included all randomized participants who received study medication and provided a baseline assessment.||units on scale||Standard Deviation|Mean
697828|NCT01362491|Secondary|Pain Relief Rating (PRR)|PRR was assessed on a 5-point categorical pain relief rating scale wherein 0=No relief to 4=Complete relief.|1, 2 & 3 hours post-dose|ITT population included all randomized participants who received study medication and provided a baseline assessment.||units on scale||Standard Deviation|Mean
697829|NCT01362491|Secondary|Time to Confirmed First Perceptible Relief|"Participants evaluated the time to first perceptible relief by stopping a stopwatch labeled 'first perceptible relief' at the moment the participant first began to experience any relief. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered. First perceptible relief was considered confirmed by meaningful relief if the participant achieved both first perceptible and meaningful relief by either depressing the second stopwatch or by indicating that his/her first perceptible relief was also meaningful."|0 to 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||minutes||95% Confidence Interval|Median
697830|NCT01362491|Secondary|Time to Onset of Meaningful Relief: Remaining Comparisons|Participants evaluated the time to meaningful relief by stopping a second stopwatch labeled ‘meaningful relief' at the moment the participant first began to experience meaningful relief. It was also considered achieved if the participant stated “meaningful relief” at the time the first stopwatch was depressed. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered.|0 to 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||minutes||95% Confidence Interval|Median
697831|NCT01362491|Primary|Time to Onset of Meaningful Relief for Ibuprofen Sodium Versus Ibuprofen (Motrin IB) Tablet|Participants evaluated the time to meaningful relief by stopping a second stopwatch labeled ‘meaningful relief' at the moment the participant first began to experience meaningful relief. It was also considered achieved if the participant stated “meaningful relief” at the time the first stopwatch was depressed. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered.|0 to 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||minutes||95% Confidence Interval|Median
697832|NCT01362491|Primary|Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference From 0-3 Hours (SPRID 0-3) for Ibuprofen Sodium Versus Placebo Tablet|SPRID:time-weighted sum of pain relief rating combined with pain intensity difference (PRID) over 3 hours. SPRID score range:-3 (worst) to 21 (best) for SPRID 0-3. PRID: sum of pain intensity differences (PID) and pain relief rating(PRR) at each time point. PRID score range: -1=worst to 7=best. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderately severe to 3=severe). Total score range for PID: -1(worst) to 3 (best). PRR:assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief).|0-3 Hours|Intent-to-treat (ITT) population included all randomized participants who received study medication and provided a baseline assessment.||units on scale||Standard Deviation|Mean
697833|NCT01362439|Secondary|Extrapyramidal Symptoms Scale (ESRS) Subscale Scores and Total Scores|Extra pyramidal symptoms attributed to antipsychotic assessed by ESRS scale. Included 4 subscales; Parkinsonism (Park),dystonia(Dyst),dyskinesia(Dysk),akathisia(Akat),12 items on 4-point scale; (0=absent-3=severe); Park (8 items); Dyst (2 items); Dysk (7 items) all 3 rated on 7-point scale (0=none/normal-6=worst). Additionally, subtotals were calculated; hyperkinesia (item 5, 6 of Park); hypokinesia (item 1-4, 7 of Park); bucco-linguo-masticatory (item 1-3 of Dysk), choreoathetoid movement (item 5, 6 of Dysk). Total score: sum of Park, Dyst & Dysk subscale, ranged from 0 (normal)-102 (severe).|Baseline and Week 13|Safety population included all participants who received atleast one dose of study medication.||units on a scale||Standard Deviation|Mean
697834|NCT01362439|Secondary|Daytime Drowsiness Evaluation Scale|This self-administered scale rates quality of sleep and daytime drowsiness. Participants will indicate on an 11-point scale how well they have slept in the previous 7 days, from 0 (very badly) to 10 (very well); and how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 10 (all the time).On the daytime drowsiness scale, score 0 corresponds to not at all and score 10 to all the time.|Baseline and Week 13|ITT included all participants who received at least one dose of study medication. For participants leaving study prematurely last available data post-baseline was used for final evaluation using LOCF method.||units on a scale||Standard Deviation|Mean
697835|NCT01362439|Secondary|Quality of Sleep Score|This self-administered scale rates quality of sleep and daytime drowsiness. Participants indicate on an 11-point scale how well they have slept in the previous 7 days, from 0 (very badly) to 10 (very well); and how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 10 (all the time). On the sleep evaluation scale, score 0 corresponds to very badly and score 10 to very well.|Baseline and Week 13|The ITT included all participants who received at least one dose of study medication. For participants leaving study prematurely last available data post-baseline was used for final evaluation using LOCF method.||units on a scale||Standard Deviation|Mean
697902|NCT01362244|Secondary|Absolute Value of the Hematology Parameter of Reticulocyte Count/Erythrocyte Uncorrected at Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Reticulocyte count was assessed at Weeks 1, 2, 5, 9, 13, 17, 21, and 25.|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Safety Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.||Fraction of 1||Standard Deviation|Mean
697836|NCT01362439|Secondary|Change From Baseline in Personal and Social Performance Scale (PSP) at Week 13|The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty).|Baseline and Week 13|The ITT included all participants who received at least one dose of study medication. For participants leaving study prematurely last available data post Baseline was used for final evaluation using LOCF method.||units on a scale||Standard Deviation|Mean
697837|NCT01362439|Secondary|Clinical Global Impression-Severity Scale (CGI-S)|The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to normal, not at all ill and a rating of 7 is equivalent to among the most extremely ill participants. Higher scores indicate worsening.|Baseline and Week 13|The ITT included all participants who received at least one dose of study medication. For participants leaving study prematurely last available data post Baseline was used for final evaluation using LOCF method.||units on a scale||Full Range|Median
697838|NCT01362439|Secondary|Change From Baseline in Drug Attitude Inventory (DAI 30) Scale at Week 13|The DAI is a 30-item self-rating inventory that focuses on subjective effects of neuroleptic medications in participants with schizophrenia. There are 15 items that are scored as true and 15 scored as false if the person is fully compliant (positive subjective response). Positive answers score as +1, negative answers score as – 1. Questionnaire allows identifying participants at high risk of low compliance. The total score may vary from -30 to +30 with a high total final score is a positive subjective response (compliant) and a low total score is a negative subjective response (non-compliant).|Baseline and Week 13|The ITT included all participants who received at least one dose of study medication. For participants leaving study prematurely last available data post-baseline was used for final evaluation using LOCF method.||units on a scale||Standard Deviation|Mean
697839|NCT01362439|Secondary|Change From Baseline in Subjective Well-being Under Neuroleptic (SWN 20) Scale at Week 13|The SWN 20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood.|Baseline and Week 13|The ITT included all participants who received at least one dose of study medication. For participants leaving study prematurely last available data post-baseline was used for final evaluation using LOCF method.||units on a scale||Standard Deviation|Mean
697840|NCT01362439|Secondary|Percentage of Participants With Greater Than or Equal to 30 Percent Treatment Response in Total Positive and Negative Syndrome Scale (PANSS) Score|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210, higher scores indicate worsening.|Baseline and Week 13|The ITT included all participants who received at least one dose of study medication. For participants leaving study prematurely last available data post-baseline was used for final evaluation using LOCF method. 'N' (number of participants analyzed) signified participants evaluable for this measure.||percentage of participants|||Number
697841|NCT01362439|Secondary|Change in Positive and Negative Syndrome Scale (PANSS) General Psychopathology Subscale Score at Week 13|The PANSS General Psychopathology Subscale Score assesses 16 general psychopathology symptoms. The symptoms are rated on a 7-point scale, with a range of 16 (absent) to 112 (extreme psychopathology).|Baseline and Week 13|The ITT included all participants who received at least one dose of study medication. For participants leaving study prematurely last available data post-baseline was used for final evaluation using LOCF method.||units on a scale||Standard Deviation|Mean
697842|NCT01362439|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score at Week 13|The PANSS Negative Subscale assesses seven negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).|Baseline and Week 13|The ITT included all participants who received at least one dose of study medication. For participants leaving study prematurely last available data post-baseline was used for final evaluation using LOCF method.||units on a scale||Standard Deviation|Mean
697843|NCT01362439|Secondary|Change in Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score at Week 13|The PANSS Positive Subscale assesses seven positive-symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).|Baseline and Week 13|The ITT included all participants who received at least one dose of study medication. For participants leaving study prematurely last available data post-baseline was used for final evaluation using LOCF method.||units on a scale||Standard Deviation|Mean
697844|NCT01362439|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Total Score at Week 13|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210, higher scores indicate worsening.|Baseline and Week 13|Intent to Treat Population (ITT) included all participants who received at least 1 dose of study medication. For participants leaving study prematurely last available data post-baseline was used for final evaluation using Last observation carried forward (LOCF) method.' N' (number of participants analyzed): participants evaluable for this measure.||units on a scale||Standard Deviation|Mean
697845|NCT01362348|Secondary|Summary of Plasma Pazonib Concentration|Throughout the study, 1 to 4 blood samples (2 mL) were collected from each participants for the analysis of plasma pazopanib concentrations between 0.55 to 10.83 hours post-dose on Weeks 2, 3, 4, 6 (unplanned), 8 (unplanned) and 12. The concentrations from the three blood samples per participant were averaged and then the values were averaged through all the participants. Blood samples were collected without restriction for the time interval between blood draw and the last dose of pazopanib eye drops.|Up to Week 12|Pharmacokinetic Population was defined as participants in the ITT Population for whom a pharmacokinetic sample was obtained and analyzed. Only those participants available at the specified time points were analyzed.||nanograms per milliliter||Standard Deviation|Mean
697846|NCT01362348|Secondary|Number of Participants With Abnormal Urinalysis Data by Urine Microscopy and Dipstick Analysis|Urinalysis measurements included assessments for red blood cells and white blood cells via microscopic examination while assessments for urine protein by standard dipstick analysis. Data has been presented for the number of participants with abnormal urinalysis results.|Up to Follow-up (Day 102)|Safety Population. Only those participants available at the specified time points were analyzed,||Participants|||Count of Participants
697847|NCT01362348|Secondary|Number of Participants With Clinical Chemistry and Hematology Data of Potential Clinical Concern|Clinical chemistry parameters included albumin, alkaline phosphatase, alanine amino transferase, aspartate amino transferase, direct bilirubin, total bilirubin, calcium, chloride, carbon dioxide, creatinine, thyroxine (T3 free), gamma glutamyl transferase, glucose, potassium, sodium, total protein, total T3, urea, uric acid while hematology included basophils, eosinophils, hemoglobin, hematocrit, lymphocytes, mean corpuscle hemoglobin concentration, mean corpuscle hemoglobin, mean corpuscle volume, monocytes, segmented neutrophils, total neutrophils, platelet count, red blood cell count, reticulocytes and white blood cell count. The potential clinical concern ranges were as follows: glucose-low <3 and high >9 millimoles per liter (mmol/L), carbon dioxide-low <18 and high >34 mmol/L, lymphocyte-low <0.8 giga per liter (G/L) and platelet count was <100 and high >550 G/L. Data has been presented for the number of participants with values high and low of potential clinical concern.|Up to Follow-up (Day 102)|Safety population.||Participants|||Count of Participants
697848|NCT01362348|Secondary|Number of Participants With Vital Sign Data of Potential Clinical Concern|Vital sign assessments included systolic blood pressure, diastolic blood pressure and heart rate. The potential clinical concern range for systolic blood pressure was <85 and >160 millimeters of mercury, diastolic blood pressure <45 and > 100 millimeters of mercury, heart rate <40 and >110 beats per minute. Data has been presented in a consolidated format for the total number of participants with values of potential clinical concern for systolic blood pressure, diastolic blood pressure and heart rate until Day 102.|Up to Follow-up (Day 102)|Safety Population||Participants|||Count of Participants
697849|NCT01362348|Secondary|Number of Participants With Values of Potential Clinical Concern for Ocular Assessments on General Ophthalmic Examination|A complete eye examination was performed to include the following: Examination of eyelids and lashes (including meibomian glands), Pupil, motility and confrontation visual field examination, Slit lamp evaluation of anterior ocular structures (including conjunctiva, tear film, cornea with fluorescein staining, anterior chamber, iris, lens, and anterior vitreous), Intraocular pressure (IOP) measurement and Dilated Fundus Examination (Indirect ophthalmoscopy and slit lamp biomicroscopy). Data has been presented in a consolidated format for the total number of participants with values of potential clinical concern for complete ophthalmic examinations until Day 102.|Up to Follow-up (Day 102)|Safety Population.||Participants|||Count of Participants
697850|NCT01362348|Secondary|Number of Participants With Ocular Adverse Events (AEs), Non-ocular AEs, Serious Ocular AEs and Serious Non-ocular AEs|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury.|Until Follow-up (Day 102)|Safety Population.||Participants|||Count of Participants
697851|NCT01362348|Secondary|Number of Participants Who Received Rescue Medication|At any time during the study, including the follow-up period, rescue treatment (standard of care) was given based on the clinical judgment of the investigator. Rescue treatment was to be strongly considered for participants whose center subfield thickness had increased by >50 microns from the lowest value on study or whose BCVA decreased by more than 5 letters compared to baseline and who also had persistent fluid by OCT. Data has been reported for the number of participants with their percentages who required any rescue medication administration until follow-up.|Up to follow-up (Day 102)|Safety Population comprised of any participant who received at least one dose of study medication.||Participants|||Count of Participants
697852|NCT01362348|Secondary|Number of Participants With Change in Charactertsics (Atrophy, Pigment, SR Hemorrhage, IR Hemorrhage, SR Fluid and Fibrosis) as Measured by FP|Fundus photography involves capturing of images of the center of the very back inner wall of the eye — the retina, optic nerve, macula and main retinal blood vessels. The parameters assessment were heme SR hemorrhage (absence or presence at the location), heme IR hemorrhage (absence or presence at the location), SR fluid (absence or presence at location), fibrosis (absence or presence at location), atrophy (absence or presence of atrophic changes) and pigment (absence or presence at location). A protocol set of fundus photographs were obtained at Day 29. Images were read by the investigator for eligibility determination, and by a central reading center for determination of PD effect. Data has been presented for number of participants with changes in eye characteristics in the study eye at Day 29.|Day 29|ITT Population. Only those participants with data available at the indicated time point were analyzed. OC dataset was used for analysis.||Participants|||Count of Participants
697903|NCT01362244|Secondary|Absolute Values of the Hematology Parameter of Mean Corpuscular Volume (MCV) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25|MCV was assessed at Weeks 1, 2, 5, 9, 13, 17, 21, and 25.|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Safety Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.||Femtoliters||Standard Deviation|Mean
697853|NCT01362348|Secondary|Change From Baseline in the Area of Choroidal Neovascular (CNV) Size and CNV Total Lesion Complex Size as Measured by Fluorescein Angiography (FA) at Day 29|CNV was the measurement of the combined classic and occult neovascular lesion including areas of classic neovascularization, late staining of undetermined origin and fibrovascular PED. CNV total lesion complex size was the measurement of the entire lesion including classic and occult neovascular components as well as contagious blood and/or blocked fluorescence and/or serous PED. FA uses fundus photography (FP) to capture images of injected dye circulating throughout the retinal blood vessels to assess leaking, swelling/circulation problems caused by various eye diseases like diabetic retinopathy and wet macular degeneration. A fluorescein angiogram was obtained at Day 29. Images were evaluated by investigator for eligibility and by a central reading center for determination of PD effect. Baseline was defined as the assessments performed between Day -3 to -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-randomization value at Day 29.|Baseline (Day -3 to -1) and Day 29|ITT Population. Only those participants with data available at the indicated time point were analyzed. OC dataset was used for analysis.||millimeter square||Standard Deviation|Mean
697854|NCT01362348|Secondary|Change From Baseline in BCVA Over Time|BCVA was measured in the study eye using the EVA chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the participant. A decrease in the BCVA score indicates a worsening of vision while higher scores indicates improvement of VA. Baseline was defined as the assessments performed between Day -3 to -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-randomization value at Day 29.|Baseline (Week -3 to -1) Up to Follow-up (Day 102)|ITT Population. Only those participants available at the specified time points were analyzed. OC dataset was used for analysis.||Letters||Standard Deviation|Mean
697855|NCT01362348|Secondary|Change From Baseline in Intraretinal (IR) or Subretinal (SR) Fluid Thickness, Intraretinal Cysts or Serous Retinal Pigment Epithelial Detachment (PED Thickness) Over Time|OCT was used for the determination of retinal morphology changes in the study eye which included assessments of SR fluid (an exudate between the retina and choroid from various sources including the vitreous cavity, subarachnoid space, or abnormal vessels) and PED (retinal pigment epithelium separates from the underlying Bruch's membrane due to the presence of blood, serous exudate, drusen, or a neovascular membrane). Baseline was defined as the assessments performed between Day -3 to -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-randomization value at Day 29.|Baseline (Week -3 to -1) Up to Follow-up (Day 102)|ITT Population. Only those participants available at the specified time points were analyzed. OC dataset was used for analysis.||Microns||Standard Deviation|Mean
697856|NCT01362348|Secondary|Change From Baseline in Central Retinal Lesion Thickness (CRLT) Over Time|CRLT was the manual measurement of the distance between the inner limiting membrane of the retina and the inner border of the choriocapillaris, inclusive of subretinal or sub-retinal pigment epithelium fluid collections and of the thickness of any observable choroidal neovascular membrane or scar tissue, evaluated in the central 1 mm of the Cube scan. OCT assessments were performed using SPECTRALIS spectral domain OCT. Baseline was defined as the assessments performed between Day -3 to -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-randomization value at Day 29.|Baseline (Week -3 to -1) Up to Follow-up (Day 102)|ITT Population. Only those participants available at the specified time points were analyzed. OC dataset was used for analysis.||Microns||Standard Deviation|Mean
697857|NCT01362348|Primary|Change From Baseline in Best Correct Visual Acuity (BCVA) as Measured by the Number of Letters Determined by Electronic Early Treatment Diabetic Retinopathy [ETDRS] Study Visual Acuity (EVA) at Day 29|BCVA was measured in the study eye using the EVA chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the participant. A decrease in the BCVA score indicates a worsening of vision while higher scores indicates improvement of VA. Baseline was defined as the assessments performed between Day -3 to -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-randomization value at Day 29.|Baseline (Day -3 to -1) and Day 29|ITT Population. Only those participants with data available at the indicated time point were analyzed. OC dataset was used for analysis.||Count of letters||Standard Deviation|Mean
697858|NCT01362348|Primary|Change From Baseline in Central Retinal Lesion Thickness (CRT) as Measured by Optical Coherence Tomography (OCT) at Day 29|CRT was the distance between the inner limiting membrane of the retina and the inner border of the retinal pigment epithelium/choriocapillaris band, inclusive of sub retinal fluid, measured in the central 1 millimeter (mm) of the Cube scan. OCT assessments were performed using SPECTRALIS spectral domain OCT. Images were evaluated by investigator for safety monitoring, and by a central reading center for eligibility determination and pharmacodynamics (PD) effects. Observed case (OC) data set was used for analysis in this analysis dataset, a missing assessment at any scheduled time point was considered unevaluable, was not imputed and was not included in data analysis. Baseline was defined as the assessments performed between Day -3 to -1. Change from Baseline was calculated by subtracting the baseline value from the individual post-randomization value at Day 29.|Baseline (Week 0) and Day 29|The Intent-to-treat (ITT) Population comprised of any participant who received at least one dose of study medication. Only those participants with data available at the indicated time point were analyzed. OC dataset was used for analysis.||Microns||Standard Deviation|Mean
697859|NCT01362296|Secondary|GSK1120212 Plasma Pharmacokinetic (PK) Concentration|Blood samples for PK analysis of GSK1120212 were collected at the following time points: Cycle 1 (Study Day 15), Cycle 2 (Study Day 22), Cycle 3 (Study Day 43), and Cycle 4 (Study Day 64). Post-dose PK samples collected on Day 15 of Cycle 1 occurred at least 1 hour apart. Participants were instructed to withhold the dose of GSK1120212 until after blood for PK samples had been drawn. Pre-dose samples were taken 15 minutes or less prior to taking the next dose (i.e., trough).|Day 15 of Cycle 1: pre-dose; 0.5-2 hours, 2-4 hours, and 4-8 hours post-dose; Day 1 of Cycle 2, Cycle 3 and Cycle 4: pre-dose|PK Population. Only participants with data available at the specified time points were analyzed.||Nanograms (ng)/milliliter (mL)||Standard Deviation|Mean
697860|NCT01362296|Secondary|Overall Survival (OS)|OS is defined as the interval of time between the date of randomization and the date of death due to any cause. For participants who did not die, OS was censored at the date of last contact.|Time interval between the date of randomization and the date of death due to any cause (maximum of 22 months)|MITT Population||Months||95% Confidence Interval|Median
699172|NCT01347840|Primary|Area Under the Curve of Ghrelin and GLP-1|These variables will measure the combined effects of hormone concentration and duration.|16 months|||units on a scale|||Number
697861|NCT01362296|Secondary|Duration of Response (DOR) as Assessed by the Investigator: Randomized Phase|DOR was assessed by the investigator for participants with CR (disappearance of all target and non-target lesions; any pathological lymph nodes must be <10 mm in the short axis; without the appearance of new lesions) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]). DOR is defined as the time from the first documented evidence of CR or PR until the earliest date of documented radiological progression or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters (SD) of target lesions with an absolute increase of at least 5 millimeters (mm) or the appearance of at least 1 new lesion, or the worsening of non-target lesions significant enough to require study treatment discontinuation.|Time from the first documented evidence of CR or PR until the earliest date of documented radiological progression or death due to any cause (maximum of 10.2 months)|MITT Population. Only participants who achieved a CR or PR were analyzed for duration of response.||Weeks||95% Confidence Interval|Mean
697862|NCT01362296|Secondary|Number of Participants With a Best Response of Either a CR or PR as Assessed by the Investigator: Crossover Phase|Response was assessed by the investigator according to RECIST, version 1.1, using confirmed and unconfirmed responses. Responders were defined as participants achieving either a CR (disappearance of all target and non-target lesions; any pathological lymph nodes must be <10 millimeters [mm] in the short axis; without the appearance of new lesions) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]). Participants with unknown or missing response were treated as non-responders.|From the date of the first dose of study treatment in the Crossover Phase until the first documented evidence of a CR or PR (maximum of 4 months)|Crossover Population||Participants|||Number
697863|NCT01362296|Secondary|Number of Participants With a Best Response of Either a Complete Response (CR) or Partial Response (PR) as Assessed by the Investigator: Randomized Phase|Response was assessed by the investigator according to RECIST, version 1.1, using confirmed and unconfirmed responses. Responders were defined as participants achieving either a CR (disappearance of all target and non-target lesions; any pathological lymph nodes must be <10 millimeters [mm] in the short axis; without the appearance of new lesions) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]). Participants with unknown or missing response were treated as non-responders.|From randomization until the first documented evidence of a CR or PR (maximum of 10.2 months)|MITT Population||Participants|||Number
697864|NCT01362296|Secondary|Change From Baseline in Heart Rate: Crossover Phase|Heart rate was measured at the following scheduled time points: Baseline; Days 1, 8, and 15 of Cycle 1 (Study Week 1); and Day 1 of every cycle therafter until treatment discontinuation.The worst-case on-therapy was determined using both scheduled and unscheduled assessments during the on-therapy period. Change from Baseline was calculated as the value at post-Baseline time point minus the value at Baseline.|Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Crossover Phase (up to Study Week 19)|Crossover Population. Only participants with data available at the specified time points were analyzed.||Beats per minute||Standard Deviation|Mean
697865|NCT01362296|Secondary|Change From Baseline in Heart Rate: Randomized Phase|Heart rate was measured at the following scheduled time points: Baseline; Days 1, 8, and 15 of Cycle 1 (Study Week 1); and Day 1 of every cycle therafter until treatment discontinuation.The worst-case on-therapy was determined using both scheduled and unscheduled assessments during the on-therapy period. Change from Baseline was calculated as the value at post-Baseline time point minus the value at Baseline.|Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Randomized Phase (up to Study Week 40)|Safety Population. Only participants with data available at the specified time points were analyzed.||Beats per minute||Standard Deviation|Mean
697866|NCT01362296|Secondary|Change From Baseline in SBP and DBP: Crossover Phase|Systolic and diastolic blood pressure were measured at the following scheduled time points: Baseline; Days 1, 8, and 15 of Cycle 1 (Study Week 1); and Day 1 of every cycle therafter until treatment discontinuation. The worst-case on-therapy was determined using both scheduled and unscheduled assessments during the on-therapy period. Change from Baseline was calculated as the value at post-Baseline time point minus the value at Baseline.|Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Crossover Phase (up to Study Week 19)|Crossover Population. Only participants with data available at the specified time points were analyzed.||mmHg||Standard Deviation|Mean
697867|NCT01362296|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Randomized Phase|Systolic and diastolic blood pressure were measured at the following scheduled time points: Baseline; Days 1, 8, and 15 of Cycle 1 (Study Week 1); and Day 1 of every cycle thereafter until treatment discontinuation. The worst-case on-therapy was determined using both scheduled and unscheduled assessments during the on-therapy period. Change from Baseline was calculated as the value at post-Baseline time point minus the value at Baseline.|Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Randomized Phase (up to Study Week 40)|Safety Population. Only participants with data available at the specified time points were analyzed.||millimeters of mercury (mmHg)||Standard Deviation|Mean
697868|NCT01362296|Secondary|Number of Participants With Any SAE or Non-serious AE: Crossover Phase|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Medical or scientific judgment should have been exercised in deciding whether reporting was appropriate in other situations. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.|From the date of the first dose of study treatment in the Crossover Phase until 30 days following discontinuation of study treatment regardless of initiation of a new cancer therapy or transfer to hospice (maximum of 12 months)|Crossover Population||Participants|||Number
699173|NCT01347840|Primary|Resting Energy Expenditure|Energy expended at rest (minimal movement) and during fasting. Resting Energy Expenditure can be expressed per minute or per hour or per day.|16 months|||units on a scale|||Number
697869|NCT01362296|Secondary|Number of Participants With Any Serious Adverse Event (SAE) or Non-serious Adverse Event (AE): Randomized Phase|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Medical or scientific judgment should have been exercised in deciding whether reporting was appropriate in other situations. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.|From randomization until 30 days following discontinuation of study treatment regardless of initiation of a new cancer therapy or transfer to hospice (maximum of 19 months)|Safety Population||Participants|||Number
697870|NCT01362296|Secondary|Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Crossover Phase|Data are presented for only those hematology parameters for which the following worst-case on-therapy changes from Baseline with respect to the normal range were observed: decrease to low, change to normal (CTN) or no change, or increase to high. Hematology parameters included: atypical lymphs, atypical lymphs (percentage [%]), basophils, eosinophils, metamyelocytes, monocytes, and myelocytes. Worst-case on-therapy changes from Baseline were summarized. Worst-case on-therapy was defined using the on-therapy window and changes were indentified using both scheduled and unscheduled assessments. Normal ranges for each parameter may vary depending on the laboratory (central versus local) and the participant (age, gender, etc.).|Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Crossover Phase (up to Study Week 19)|Crossover Population. Only participants with data available at the specified time points were analyzed.||Participants|||Number
697871|NCT01362296|Secondary|Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Randomized Phase|Data are presented for only those hematology parameters for which the following worst-case on-therapy changes from Baseline with respect to the normal range were observed: decrease to low, change to normal (CTN) or no change, or increase to high. Hematology parameters included: atypical lymphs, atypical lymphs (percentage [%]), basophils, eosinophils, metamyelocytes, monocytes, myelocytes, neutrophil bands (%). Worst-case on-therapy changes from Baseline were summarized. Worst-case on-therapy was defined using the on-therapy window and changes were indentified using both scheduled and unscheduled assessments. Normal ranges for each parameter may vary depending on the laboratory (central versus local) and the participant (age, gender, etc.).|Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Randomized Phase (up to Study Week 40)|Safety Population. Only participants with data available at the specified time points were analyzed.||Participants|||Number
697872|NCT01362296|Secondary|Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Clinical Chemistry Parameters: Crossover Phase|Data are presented for only those clinical chemistry parameters for which the following worst-case on-therapy changes from Baseline with respect to the normal range were observed: decrease to low, change to normal (CTN) or no change, or increase to high. Clinical chemistry parameters included: lactate dehydrogenase, total protein, and urea/blood urea nitrogen (BUN). Worst-case on-therapy changes from Baseline were summarized. Worst-case on-therapy was defined using the on-therapy window and changes were indentified using both scheduled and unscheduled assessments. Normal ranges for each parameter may vary depending on the laboratory (central versus local) and the participant (age, gender, etc.).|Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Crossover Phase (up to Study Week 19)|Crossover Population. Only participants with data available at the specified time points were analyzed.||Participants|||Number
697873|NCT01362296|Secondary|Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Clinical Chemistry Parameters: Randomized Phase|Data are presented for only those clinical chemistry parameters for which the following worst-case on-therapy changes from Baseline with respect to the normal range were observed: decrease to low, change to normal (CTN) or no change, or increase to high. Clinical chemistry parameters included: lactate dehydrogenase, total protein, and urea/blood urea nitrogen (BUN). Worst-case on-therapy changes from Baseline were summarized. Worst-case on-therapy was defined using the on-therapy window and changes were indentified using both scheduled and unscheduled assessments. Normal ranges for each parameter may vary depending on the laboratory (central versus local) and the participant (age, gender, etc.).|Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Randomized Phase (up to Study Week 40)|Safety Population. Only participants with data available at the specified time points were analyzed.||Participants|||Number
697874|NCT01362296|Secondary|Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Crossover Phase|Hematology parameters were summarized according to NCI CTCAE grade, version 4.0. Grade (G) 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to any G (IAG), G3, or G4 occurred. Hematology parameters included: haemoglobin (increased [inc]), haemoglobin (anemia), lymphocyte count (ct) (inc), lymphocyte ct (decreased [dec]), total absolute neutrophil count (ANC), platelet ct, and white blood cell count (WBC). Worst-case on-therapy changes from Baseline were summarized. Worst-case on-therapy was defined using the on-therapy window and changes were indentified using both scheduled and unscheduled assessments.|Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Crossover Phase (up to Study Week 19)|Crossover Population. Only participants with data available at the specified time points were analyzed.||Participants|||Number
697904|NCT01362244|Secondary|Absolute Values of the Hematology Parameter of Mean Corpuscular Hemoglobin (MCH) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25|MCH was assessed at Weeks 1, 2, 5, 9, 13, 17, 21, and 25.|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Safety Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.||Picograms (pg)||Standard Deviation|Mean
699224|NCT00001656|Other Pre-specified|Change in Extrapyramidal Movements as Measured by the Abnormal Involuntary Movements Scale (AIMS)|minimum score = 10; maximum score = 50; lower score is considered a more favorable outcome|8 week double-blind study period; baseline and 8 weeks|||scores on a scale||Full Range|Median
697875|NCT01362296|Secondary|Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Randomized Phase|Hematology parameters were summarized according to NCI CTCAE grade, version 4.0. Grade (G) 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to any G (IAG), G3, or G4 occurred. Hematology parameters included: haemoglobin (increased [inc]), haemoglobin (anemia), lymphocyte count (ct) (inc), lymphocyte ct (decreased [dec]), total absolute neutrophil count (ANC), platelet ct, and white blood cell count (WBC). Worst-case on-therapy changes from Baseline were summarized. Worst-case on-therapy was defined using the on-therapy window and changes were indentified using both scheduled and unscheduled assessments.|Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Randomized Phase (up to Study Week 40)|Safety Population. Only participants with data available at the specified time points were analyzed.||Participants|||Number
697876|NCT01362296|Secondary|Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase|Clinical chemistry parameters were summarized according to NCI CTCAE grade, version 4.0. Grade (G) 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to any grade, Grade 3, or Grade 4 occurred. Clinical chemistry parameters included: albumin, alkaline phosphatase (ALKP), alanine amino transferase (ALT), aspartate amino transferase (AST), total bilirubin, calcium (hypercalcemia), calcium (hypocalcemia), creatine kinase, creatinine, glucose (hyperglycemia), glucose (hypoglycemia), potassium (hyperkalemia), potassium (hypokalemia), sodium (hypernatremia), and sodium (hyponatremia). Worst-case on-therapy changes from Baseline were summarized. Worst-case on-therapy was defined using the on-therapy window and changes were indentified using both scheduled and unscheduled assessments.|Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Crossover Phase (up to Study Week 19)|Crossover Population: all participants who, at the point of disease progression during the Randomized Phase, elected to enter the crossover portion of the study. Only participants with data available at the specified time points were analyzed.||Participants|||Number
697877|NCT01362296|Secondary|Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase|Clinical chemistry parameters were summarized according to National Cancer Institutes (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade, version 4.0. Grade (G) 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to any G, G3, or G4 occurred. Clinical chemistry parameters included: albumin, alkaline phosphatase (ALKP), alanine amino transferase (ALT), aspartate amino transferase (AST), total bilirubin, calcium (hypercalcemia), calcium (hypocalcemia), creatine kinase, creatinine, glucose (hyperglycemia), glucose (hypoglycemia), potassium (hyperkalemia), potassium (hypokalemia), sodium (hypernatremia), and sodium (hyponatremia). Worst-case on-therapy changes from Baseline were summarized. Worst-case on-therapy was defined using the on-therapy window and changes were indentified using both scheduled and unscheduled assessments.|Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Randomized Phase (up to Study Week 40)|Safety Population: all participants (KRAS, BRAF, NRAS, and MEK1 mutation positive) that received at least one dose of study treatment, based on the actual treatment received if this differed from that to which the participant was randomized. Only participants with data available at the specified time points were analyzed.||Participants|||Number
697878|NCT01362296|Primary|Progression-Free Survival (PFS) as Assessed by the Investigator (INV)|PFS is defined as the time from RAN until the earliest date of documented radiological PD or DT due to any cause. PD was assessed by the INV according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. PD is defined as at least a 20% increase in the sum of the diameters (SD) of target lesions with an absolute increase of at least 5 millimeters (mm) or the appearance of at least 1 new lesion, or the worsening of non-target lesions significant enough to require study treatment discontinuation. For participants (PAR) who did not have a documented date of PD or DT, PFS was censored at the date of the last adequate assessment. For PAR who received subsequent anti-cancer therapy prior to the date of documented PD or DT, PFS was censored at the date of the last adequate assessment prior to the initiation of therapy.|From randomization (RAN) until the earliest date of documented radiological disease progression (PD) or death (DT) due to any cause (maximum of 10.2 months)|Modified Intent-to-Treat (MITT) Population: all randomized participants with KRAS mutation-positive non-small cell lung cancer (NSCLC), whether or not treatment was administered||Weeks||95% Confidence Interval|Median
697879|NCT01362244|Secondary|Number of Participants With Positive Immunogenicity (Anti-mepolizumab Antibody Testing)|Blood samples were collected at Weeks 1, 5, 13, and 25 for anti-mepolizumab antibody testing.|Weeks 1, 5, 13, and 25|ITT Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.||Participants|||Number
697880|NCT01362244|Secondary|PK/PD Model Derived Maximum Inhibition|Blood samples were collected for the assessment of Maximum Inhibition at Weeks 1, 2, 5, 9, 13, 17, 21 and 25. An exploratory Emax direct response model was fitted to serial blood eosinophil count data (including placebo) using model-predicted mepolizumab concentrations (with zero imputed for placebo treated participants). All available datapoints were incorporated into the model. Individual values are estimated from the model as post-hoc values after incorporating between-participant variability.|Weeks 1, 2, 5, 9, 13, 17, 21 and 25|PK Population. Only those participants available at the specified time points were analyzed.||Percentage of inhibition||Standard Error|Least Squares Mean
697881|NCT01362244|Secondary|PK/PD Model Derived Half Maximal Effective Drug Concentration (EC50)|Blood samples were collected for the assessment of PK/PD model derived EC50 at Weeks 1, 2, 5, 9, 13, 17, 21 and 25. An exploratory Emax direct response model was fitted to serial blood eosinophil count data (including placebo) using model-predicted mepolizumab concentrations (with zero imputed for placebo treated participants). All available datapoints were incorporated into the model. Individual values are estimated from the model as post-hoc values after incorporating between-partcipant variability.|Weeks 1, 2, 5, 9, 13, 17, 21 and 25|PK Population. Only those participants available at the specified time points were analyzed.||Microgram per liter||Standard Error|Least Squares Mean
703398|NCT00094900|Secondary|Mean Change in WBCs|White Blood Cell count change from baseline to 3 months|3 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||x 10^3 cells/microliter||Standard Error|Mean
697882|NCT01362244|Secondary|PK/PD Model Derived Coefficient of Variation of Baseline (CV[Baseline]), Variation of Maximal Effect of Drug (CV[Emax]), and Residual|A residual is the difference between the observed and predicted values. Blood samples were collected for the assessment of PK/PD model derived CV(Baseline), CV(Emax), and residual at Weeks 1, 2, 5, 9, 13, 17, 21 and 25. An exploratory Emax direct response model was fitted to serial blood eosinophil count data (including placebo) using model-predicted mepolizumab concentrations (with zero imputed for placebo treated subjects). All available datapoints were incorporated into the model. Individual values are estimated from the model as post-hoc values after incorporating between-participant variability.|Weeks 1, 2, 5, 9, 13, 17, 21 and 25|PK Population. Only those participants available at the specified time points were analyzed.||Percentage of variation||Standard Error|Least Squares Mean
697883|NCT01362244|Secondary|Pharmacokinetic/Pharmacodynamic (PK/PD) Model Derived Baseline|Blood samples were collected for the assessment of PK/PD model derived Baseline at Weeks 1, 2, 5, 9, 13, 17, 21 and 25. An exploratory Emax direct response model was fitted to serial blood eosinophil count data (including placebo) using model-predicted mepolizumab concentrations (with zero imputed for placebo treated participants). All available blood eosinophil count data were incorporated into the model. Individual values were estimated from the model as post-hoc values after incorporating between-participant variability.|Weeks 1, 2, 5, 9, 13, 17, 21 and 25|PK Population. Only those participants available at the specified time points were analyzed.||Giga units per liter||Standard Error|Least Squares Mean
697884|NCT01362244|Secondary|Half-life (Alpha) and Half-life (Beta)|Half-life (Alpha) is the rate of decline in plasma concentrations due to the process of drug redistribution from the central to the peripheral compartment and half-life (Beta ) is the rate of decline due to the process of drug elimination due to metabolism. Blood samples were collected for the assessment of half-life (Alpha) and half-life (Beta) at Weeks 1, 2, 5, 9, 13, and 25. Half-life was estimated using a population-pharmacokinetic model incorporating all available data points from all participants. Individual values were estimated from the model as post-hoc values after incorporating between-participant variability.|Weeks 1, 2, 5, 9, 13, and 25|PK Population. Only those participants available at the specified time points were analyzed.||Days||Standard Error|Least Squares Mean
697885|NCT01362244|Secondary|Area Under the Plasma Drug Concentration Versus Time Curve From Time 0 Extrapolated to Infinite Time (AUC[0-inf])|Blood samples were scheduled to be collected for the assessment of AUC(0-inf) at Weeks 1, 2, 5, 9, 13, and 25 AUC[0-inf] is derived from individual systemic clearance estimates using the expression AUC[0-inf] = Dose/CL. Hence all data are incorporated into the estimation of CL and by implication AUC[0-inf]. The actual time range over which pharmacokinetic data were collected was from time 0 to 336 days post first dose.|Weeks 1, 2, 5, 9, 13, and 25|PK Population. Only those participants available at the specified time points were analyzed.||Microgram.day per milliliter||Standard Error|Least Squares Mean
697886|NCT01362244|Secondary|Maximum Observed Plasma Drug Concentration (Cmax), Average Concentration (Cav[0-inf]), and Steady State Maximum Observed Plasma Drug Concentration (Cmax SS)|Blood samples were collected for the assessment of Cmax, Cav(0-inf), and Cmax SS at Weeks 1, 2, 5, 9, 13, and 25. These parameters were estimated using a population-pharmacokinetic model incorporating all available data points from all participants. Individual values were estimated from the model as post-hoc values after incorporating between-participant variability.|Weeks 1, 2, 5, 9, 13, and 25|PK Population. Only those participants available at the specified time points were analyzed.||Micrograms per milliliter||Standard Error|Least Squares Mean
697887|NCT01362244|Secondary|Steady-State Volume of Distribution|Steady-state volume of distribution is the blood and tissue volume into which a drug is distributed and the relative binding of drug to protein in these spaces. Blood samples were collected for the assessment of steady-state volume of distribution at Weeks 1, 2, 5, 9, 13, and 25. Steady-state volume of distribution was estimated using a population-pharmacokinetic model incorporating all available data points from all participants. Individual values were estimated from the model as post-hoc values after incorporating between-participant variability.|Weeks 1, 2, 5, 9, 13, and 25|PK Population. Only those participants available at the specified time points were analyzed.||Liters||Standard Error|Least Squares Mean
697888|NCT01362244|Secondary|Bodyweight-adjusted Clearance|Clearance is the volume of plasma that would contain the amount of drug excreted per day. Blood samples were collected for the assessment of bodyweight-adjusted clearance at Weeks 1, 2, 5, 9, 13, and 25. Clearance was estimated using a population-pharmacokinetic model incorporating all available data points from all participants. Individual values were estimated from the model as post-hoc values after incorporating between-participant variability.|Weeks 1, 2, 5, 9, 13, and 25|PK Population. Only those participants available at the specified time points were analyzed.||Liters per day||Standard Error|Least Squares Mean
697889|NCT01362244|Secondary|Volume of Distribution at Weeks 1, 2, 5, 9, 13, and 25|Volume of distribution at steady-state was derived from pharmacokinetic parameter estimates of a population pharmacokinetic model. Blood samples were collected for analysis of volume of distribution at Weeks 1, 2, 5, 9, 13, and 25. All available concentrations at all available datapoints from all participants were incorporated into the model. Individual values were estimated from the model as post-hoc values after incorporating between-participant variability.|Weeks 1, 2, 5, 9, 13, and 25|PK Population. Only those participants available at the specified time points were analyzed.||Liters||Standard Deviation|Mean
697890|NCT01362244|Secondary|Systemic Clearance at Weeks 1, 2, 5, 9, 13, and 25|Blood samples were collected for the assessment of systemic clearance at Weeks 1, 2, 5, 9, 13, and 25. Systemic Clearance (CL) is estimated using a population-Pharmacokinetic model incorporating all available data points from all subjects. Individual values were estimated from the model as post-hoc values after incorporating between-participant variability.|Weeks 1, 2, 5, 9, 13, and 25|Pharmacokinetic (PK) Population: participants in the Safety Population for whom at least one PK sample was obtained and analyzed.||Liters per day||Standard Deviation|Mean
697891|NCT01362244|Secondary|VAS Score of the EQ-5D Questionnaire at Week 25 (Adjusting for Week 1 Baseline Scores)|The EQ-5D is a standardized, 2-part questionnaire used to measure health outcomes. The second part of the questionnaire is a VAS question, requiring the participant to self rate his/her health score on a scale of 0 (worst imaginable health state) to 100 (best imaginable health state). ANCOVA model with treatment, Baseline (Week 1 scores) and country as factors was used to calculate treatment difference and confidence intervals at Week 25.|Week 1 and Week 25|ITT Population||Scores on a scale||Standard Error|Least Squares Mean
729960|NCT00392678|Secondary|Response Rates for Exceeding Hyperglycemic Targets Between Active and Placebo Treated Groups|Please see adverse events module for hyperglycemia.|14 week||||||
697892|NCT01362244|Secondary|Index Score of the EuroQoL Quality of Life-5D (EQ-5D) Questionnaire at Week 25 (Adjusting for Week 1 Baseline Scores)|The EQ-5D is a standardized, 2-part questionnaire used to measure health outcomes. The first part contains descriptions of the following five components: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Responses to each of the five domains are measured on a 3-point scale (1-no problems, 2-some problems, and 3-severe problems). An index for the descriptive scores was derived using the general European weights, obtained for each of the countries in this study. Index scores were derived for each participant at each time point. ANCOVA model with treatment, Baseline (Week 1 scores) and country as factors was used to calculate treatment difference and confidence intervals at Week 25.|Week 1 and Week 25|ITT Population||Scores on a scale||Standard Error|Least Squares Mean
697893|NCT01362244|Secondary|Sino-Nasal Outcome Test (SNOT)-22 Questionnaire Total Score at Week 25 (Adjusted for Week 1 Baseline)|"SNOT-22 questionnaire is a modification of the SNOT-20 and contains the questions (ques) related to smell and nasal obstruction. Each ques is graded with a numerical score for each response (res); scores range from 0 for no symptoms to 5 for as bad as things could be. Scores for each of the ques is summed to derive the total score for that par. at that visit. If the par. did not complete any ques at a visit, then he/she were not to have any missing values imputed, and his/her total score for that visit was set to missing. If a par. had some missing scores (but no more than 50% missing at that visit), then scores for the missing resp were imputed as the mean of the non-missing resp for that par. at that visit. The SNOT-22 total score ranges from 0 to 110, with higher scores representing a worse quality of life. Questionnaire data analysis was done using an ANCOVA to obtain the LS-means, treatment difference and confidence interval at Week 25, adjusting for Week 1 Baseline scores."|Week 1 and Week 25|ITT Population||Scores on a scale||Standard Error|Least Squares Mean
697894|NCT01362244|Secondary|Olfaction Testing: Worst Nostril Score (WNS) and Mean Nostril Score (MNS) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Sniffin’Sticks were used to assess each participant’s sense of smell (olfaction). Olfaction testing results were recorded for both the right and left nostrils The worst nostril score (number of correct answers for the worst nostril) and the mean nostril score (mean number of correct answers across both nostrils) were recorded. Scores range from 0 to 12 (high score indicating normal olfactory sensation). Olfaction data are plotted and analyzed using a repeated measures model to calculate treatment difference, confidence intervals and p-values.|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|ITT Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.||Scores on a scale||95% Confidence Interval|Least Squares Mean
697895|NCT01362244|Secondary|Mean Peak Nasal Inspiratory Flow (PNIF) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Participants used a portable hand-held inspiratory flow meter to measure and record PNIF in the morning prior to taking the study medication. Three measurements were taken, and the largest measurement was recorded in the electronic diary. PNIF data is plotted and analyzed using a repeated measures model to calculate treatment difference, confidence intervals and p-values.|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|ITT Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.||L/min||95% Confidence Interval|Least Squares Mean
697896|NCT01362244|Secondary|Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25|"Participants were asked to indicate on a VAS (0 to 10 centimeters) the severity of four nasal polyposis symptoms (one VAS for each symptom): rhinorrhea; mucus in the throat; nasal blockage; loss of smell. The left-hand side of the scale (0) represents “not troublesome,” and the right hand side of the scale (10) represents “worst possible troublesome."|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|PP Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.||Scores on a scale||Standard Deviation|Mean
697897|NCT01362244|Secondary|Mean Peak Expiratory Flow Rate (PEFR) at Indicated Weeks 1, 2, 5, 9, 13, 17, 21, and 25|PEFR is defined as the maximum airflow generated during a forced expiration beginning with the lungs fully inflated. PEFR was calculated as the maximum of three readings taken at each time point for each participant. Spirometry data is plotted and analyzed using a repeated measures model to calculate treatment difference, confidence intervals and p-values.|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|ITT Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.||Liters/minute (L/min)||95% Confidence Interval|Least Squares Mean
697898|NCT01362244|Secondary|Mean of Forced Vital Capacity (FVC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25|FVC is defined as the maximum amount of air that can forcibly be blown out after a maximum inspiration. FVC was calculated as the maximum of three readings taken at each time point for each participant. Spirometry data are plotted and analyzed using a repeated measures model to calculate treatment difference, confidence intervals and p-values.|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|ITT Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.||Liters||95% Confidence Interval|Least Squares Mean
697899|NCT01362244|Secondary|Mean of the Forced Expiratory Volume in 1 Second (FEV1) at Weeks 2, 5, 9, 13, 17, 21, and 25|FEV1 is defined as the volume of air forcefully expelled from the lungs in one second. FEV1 measurements were taken by spirometry at each clinic visit. FEV1 was calculated as the maximum of three readings taken at each time point for each participant. Spirometry data is plotted and analyzed using a repeated measures model to calculate treatment difference, confidence intervals and p-values.|Weeks 2, 5, 9, 13, 17, 21, and 25|ITT Population: all randomized participants who received at least one dose of study treatment. Only those participants available at the specified time points (represented by n=X, X) were analyzed.||Liters (L)||95% Confidence Interval|Least Squares Mean
697900|NCT01362244|Secondary|Number of Participants With Any Treatment-emergent Adverse Event (AE) and Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or is associated with liver injury and impaired liver function.|Up to Week 25|Safety Population||Participants|||Number
697907|NCT01362244|Secondary|Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Platelet count, WBC count, basophils, eosinophils, lymphocytes, monocytes, and neutrophils were assessed at Weeks 1, 2, 5, 9, 13, 17, 21, and 25.|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Safety Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.||10^9 cells per liter||Standard Deviation|Mean
697908|NCT01362244|Secondary|Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Total and direct bilirubin, creatinine, and uric acid were assessed at Weeks 1, 2, 5, 9, 13, 17, 21, and 25.|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Safety Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.||Micromoles per liter||Standard Deviation|Mean
697909|NCT01362244|Secondary|Absolute Values of the Clinical Chemistry Parameters of Albumin and Protein at Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Albumin and protein were assessed at Weeks 1, 2, 5, 9, 13, 17, 21, and 25.|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Safety Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.||Grams per liter (g/L)||Standard Deviation|Mean
697910|NCT01362244|Secondary|Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25|ALT, AST, ALP, and GGT were assessed at Weeks 1, 2, 5, 9, 13, 17, 21, and 25.|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Safety Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.||International units per liter (IU/L)||Standard Deviation|Mean
697911|NCT01362244|Secondary|Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25|BUN, glucose fasting, chloride, sodium, potassium, carbon dioxide (CO2), and calcium were assessed at Weeks 1, 2, 5, 9, 13, 17, 21, and 25.|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Safety Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.||Millimoles per liter (mmol/L)||Standard Deviation|Mean
697912|NCT01362244|Secondary|Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Weeks 1, 2, 5, 9, 13, 17, 21, and 25|A single safety 12-lead ECG was performed using a standard 12-lead ECG machine at Weeks 1, 2, 5, 9, 13, 17, 21, and 25. Any abnormal clinically significant (CS) and not clinically significant (NCS) findings were identified. ECG abnormaility with respect to CS and NCS findings were judged by the investigator or appropriately qualified designee.|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Safety Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.||Participants|||Number
697913|NCT01362244|Secondary|Mean Change From Baseline in Pulse Rate at Weeks 2, 5, 9, 13, 17, 21, and 25|Pulse rate was measured at Baseline (Week 1) and at Weeks 2, 5, 9, 13, 17, 21, and 25. Baseline is defined as the Week 1 pre-dose assessment. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value.|Baseline and Weeks 2, 5, 9, 13, 17, 21, and 25|Safety Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.||beats per minute||Standard Deviation|Mean
697914|NCT01362244|Secondary|Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 2, 5, 9, 13, 21, and 25|SBP and DBP were measured at Baseline (Week 1) and at Weeks 2, 5, 9, 13, 17, 21, and 25. Baseline is defined as the Week 1 pre-dose assessment. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value.|Baseline and Weeks 2, 5, 9, 13, 17, 21, and 25|Safety Population: participants who received >=1 dose of study treatment (based on actual treatment received). A participant randomized to mepolizumab took placebo in error. Thus, “N” for the placebo arm of the SP is greater than for the ITT Population. Participants available at the specified time points (represented by n=X, X) were analyzed.||millimeters of mercury (mmHg)||Standard Deviation|Mean
697915|NCT01362244|Secondary|Number of Participants Who Required Polyp Surgery at Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Assessment of the nasal polyposis condition was performed after 6 months of dosing to determine the situation indicative of a reduction in the need for surgery. The components used to determine the need for surgery were endoscopic polyp scores and a severity of condition as measured by a VAS. Surgery was required for participants with ENP scores of >=3, or ENP scores of 2 and a VAS symptom score of >7.|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|PP Population||Participants|||Number
697916|NCT01362244|Secondary|Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Screening and Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Each nostril was assessed for polyps and graded at Screening and at Weeks 1, 2, 5, 9, 13, 17, 21, and 25. The ENP score ranges from 0 (no polyps) to 4, with a higher score indicating a larger polyp. The ENP score was recorded for both the right and the left nostril. The higher of the two scores was derived and used for the analysis.|Screening; Weeks 1, 2, 5, 9, 13, 17, 21, and 25|PP Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.||Participants|||Number
697917|NCT01362244|Primary|Number of Participants With a Reduced Need for Surgery at the End of the Study (Week 25)|Assessment of the nasal polyposis condition was performed after six months of dosing to determine the situation indicative of a reduction in the need for surgery. The components used to determine the need for surgery were endoscopic polyp scores and a severity of condition as measured by a visual analogue scale (VAS). Surgery was still deemed required for a participant with an ENP score of >=3, or an ENP score of 2 and a VAS symptom score of >7. The number of participants with reduced need for polyp surgery are presented as missing data set to non-responders (NR) and missing data last observation carry forward (LOCF). LOCF is defined as missing responses at Week 25 imputed with the last non-missing post-dose observation for that participant.|Week 25|Per Protocol Population: all randomized participants who received at least one dose of study treatment and who complied with the protocol.||Participants|||Number
697918|NCT01362205|Secondary|Resource Utilization Costs Associated With This Hospitalization Billed by Facility.||Up to 28 days|The overall number of participants analyzed is less than the number randomized as data was not available for research use at many of the participating institutions.||USD||Inter-Quartile Range|Median
697919|NCT01362205|Secondary|Resource Utilization Costs Associated With This Hospitalization Billed by Physicians.||up to 28 Days|||Dollar (United States)||Inter-Quartile Range|Median
697920|NCT01362205|Secondary|Scores at Hospital Discharge on the PTSD Civilian Checklist|PTSD checklist consists of 17 questions graded on a scale of 1 to 5. The PTSD score is comprised from the sum of the scores 17 questions. The PTSD score has possible values from to 17 to 85 with higher values indicating greater symptom severity.|Up to 28 days|The number of participants analyzed was lower than the total included as many patients were discharged quickly upon resolution of altered mental status when a research team member was unavailable to administer the questionnaires.||units on a scale||Inter-Quartile Range|Median
697921|NCT01362205|Secondary|Scores at Hospital Discharge on the Beck Anxiety Inventory|The Beck Anxiety Inventory is a validated questionnaire used to measure severity of anxiety (min score 0, max score 63). The higher the score the greater the severity of anxiety. A score of 30-63 indicates severe anxiety, 17-29 moderate anxiety, 10-16 mild anxiety and 0-9 minimal anxiety.|Up to 28 days.|||units on a scale||Standard Deviation|Mean
697922|NCT01362205|Secondary|Scores at Hospital Discharge on the Beck Depression Inventory.|The Beck Depression Inventory is a validated questionnaire used to measure severity of depression (min score 0, max score 63). The higher the score the greater the severity of depression. A score of 30-63 indicates severe depression, 19-29 moderate depression, 10-18 mild depression and 0-9 minimal depression.|Up to 28 days.|||units on a scale||Standard Deviation|Mean
697923|NCT01362205|Secondary|Scores at Hospital Discharge on the Mini Mental Exam.|The Mini Mental State Examination or Folstein test is a validated 30-point questionnaire used to measure cognitive impairment (min score 0, max score 30). A score of 24 points (out of a max of 30) indicates normal cognition, less than or equal to 9 points indicates severe impairment, 10-18 indicates moderate impairment and 19-23 mild impairment.|up to 28 days|||units on a scale||Standard Deviation|Mean
697924|NCT01362205|Secondary|The Length in Days of the Hospital Stay|A hospital day is counted for any time on a calendar day the patient is admitted to the hospital. Hospital days are inclusive of ICU days.|up to 28 days|||days||Inter-Quartile Range|Median
697925|NCT01362205|Secondary|Number of Ventilator Free Days After Randomization.|A ventilator day is counted for any use of invasive mechanical ventilation during a calendar day|up to 28 days|||days||Inter-Quartile Range|Median
697926|NCT01362205|Secondary|The Number of CAM-ICU Negative Days After Randomization.|The Confusion Assessment Method (CAM)-ICU is a validated instrument used to detect the presence or absence of delirium in the ICU. A delirium free day is counted for any day a patient is negative by the CAM-ICU. The higher the number of CAM-ICU negative days indicates the more days a patient was able to think clearly.|up to 28 days|||days||Inter-Quartile Range|Median
697927|NCT01362205|Secondary|Average MINDS Score|Minnesota Detoxification Scale (MINDS) min score 0, max score 46. The higher the score, the worse the symptoms of AWS/AWD.|up to 28 days|||units on a scale||Inter-Quartile Range|Median
697928|NCT01362205|Primary|The Length of ICU Stay Defined as the Time Between Randomization and ICU Transfer Orders.||up to 28 days in hours|||hours||Inter-Quartile Range|Median
697929|NCT01362192|Secondary|Mean Pain Score Associated With Laser Treatment|Subjects will be asked to rate the average pain experienced during laser treatments using the 0-10 numeric pain rating scale (0 = no pain to 10 = worst possible pain).|12 weeks (2nd laser treatment)|intent-to-treat||Numeric Pain Rating Score||Standard Deviation|Mean
697930|NCT01362192|Secondary|Mean Pain Score Associated With Laser Treatment.|Subjects will be asked to rate the average pain experienced during laser treatments using the 0-10 numeric pain rating scale (0 = no pain to 10 = worst possible pain).|Day 0 (1st laser treatment)|intent-to-treat||Numeric Pain Rating Score||Standard Deviation|Mean
697931|NCT01362192|Secondary|Percent of Subjects Satisfied With Improvement of Treated Spider Veins.|"Subjects will assess their satisfaction with the procedure and with the improvement in lower extremity spider veins at twelve weeks post final laser treatment based using the following scale:
1 = Very Much Not Satisfied
2 = Not Satisfied
3 = Somewhat Satisfied
4 = Satisfied
5 = Very Much Satisfied"|24 weeks (12 weeks post-final laser treatment)|per protocol||percent of participants|||Number
697932|NCT01362192|Secondary|"Percent of Subjects With Significant to Very Significant Improvement of Lower Extremity Spider Veins, as Assessed by Subject."|"Subjects will be asked to rate the improvement of each treated area of their lower extremity spider veins as compared to baseline using the following scale:
0 = No Improvement (0%)
1 = Mild Improvement (< 25%)
2 = Moderate Improvement (26 to 50%)
3 = Significant Improvement (51 to 75%)
4 = Very Significant Improvement (76 to 100%)"|24 weeks (12 weeks post-final laser treatment)|per protocol||percent of participants|||Number
697933|NCT01362192|Secondary|"Percent of Subjects With Significant or Very Significant Improvement in Lower Extremity Spider Veins, as Assessed by the Treating Investigator."|"The Investigator will perform the Physician's Global Assessment of the degree of improvement for each treated area of the subject's lower extremity spider veins using the following scale:
0 = No Improvement (0%)
1 = Mild Improvement (< 25%)
2 = Moderate Improvement (26 to 50%)
3 = Significant Improvement (51 to 75%)
4 = Very Significant Improvement (76 to 100%)"|24 weeks (12 weeks post-final laser treatment)|per protocol||percent of participants|||Number
697934|NCT01362192|Secondary|Mean Improvement of Lower Extremity Spider Veins Based on Blinded Photo Assessments|"The panel of independent physicians will be asked to select the baseline photograph for each treated area and then rate the degree of improvement using the following scale:
0 = No Improvement (0%)
1 = Mild Improvement (< 25%)
2 = Moderate Improvement (26 to 50%)
3 = Significant Improvement (51 to 75%)
4 = Very Significant Improvement (76 to 100%)"|12 weeks (post-1st laser treatment)|per protocol||points on Improvement scale||95% Confidence Interval|Mean
697935|NCT01362192|Primary|Mean Improvement of Lower Extremity Spider Veins Based on Blinded Photo Assessments|"A panel of independent physicians will assess before and after digital photographs of each treated area. The physicians will be blinded to the treatment parameters and to the temporal order of the before and after photographs. Each independent physician will be asked to select the baseline photograph for each treated area and then rate the degree of improvement using the following scale:
0 = No Improvement (0%)
1 = Mild Improvement (< 25%)
2 = Moderate Improvement (26 to 50%)
3 = Significant Improvement (51 to 75%)
4 = Very Significant Improvement (76 to 100%)"|24 weeks (12 weeks post-final laser treatment)|per protocol||points on Improvement scale||95% Confidence Interval|Mean
698695|NCT01352845|Primary|Percentage of Participants Reporting at Least 1 Medically Attended Adverse Event Throughout the Study Period||From the first vaccination up to 6 month after the third vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or saline) and had safety data available.||Percentage of participants||95% Confidence Interval|Number
697945|NCT01362062|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI): Mean Change From Baseline at Every Visit|HAQ-DI is a self-completed patient questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Each domain has at least 2 component questions. There are 4 possible responses for each component 0=without any difficulty, 1=with some difficulty, 2=with much difficulty and 3=unable to do. The HAQ-DI is the sum of the scores from all domains and ranged from 0 (best) to 24 (worst). A negative change from baseline indicated improvement.|Visit 2 (Baseline), Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 12), Visit 6 (Week 16), Visit 7 (Week 20), Visit 8 (Week 24), Visit 9 (Week 28), Visit 10 (Week 32), Visit 11 (Week 36), Visit 12 (Week 40), Visit 13 (Week 44)|Efficacy analysis population. Number of participants analyzed = number of participants evaluable for this outcome.||units on scale||Standard Deviation|Mean
698997|NCT01349920|Primary|Change From Baseline in REG3-A at Week 22|Concentrations of the serum biomarker REG3-A were determined at baseline and at Week 22. The change from baseline was Week 22 minus baseline.|Baseline and Week 22|Participants with measurements for REG3-A at both baseline and at Week 22.||ng/mL||Standard Deviation|Mean
697946|NCT01362062|Secondary|Participant's Assessment of Pain Using VAS: Mean Change From Baseline at Every Visit|The participant assessed their pain on a 0 to 100 mm horizontal VAS. The left-hand extreme of the line equals 0 mm, and is described as “no pain” and the right-hand extreme equals 100 mm, and is described as “unbearable pain”. A negative change indicated improvement.|Visit 2 (Baseline), Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 12), Visit 6 (Week 16), Visit 7 (Week 20), Visit 8 (Week 24), Visit 9 (Week 28), Visit 10 (Week 32), Visit 11 (Week 36), Visit 12 (Week 40), Visit 13 (Week 44)|Efficacy analysis population. Number of participants analyzed = number of participants evaluable for this outcome.||millimeters||Standard Deviation|Mean
697947|NCT01362062|Secondary|Physician's Global Assessment of Disease Activity Using VAS: Mean Change From Baseline at Every Visit|The physician’s global assessment of disease activity is assessed on a 0 to 100 mm horizontal VAS by the physician. The left-hand extreme of the line equals 0 mm, and is described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, and is described as “maximum disease activity” (maximum arthritis disease activity).|Visit 2 (Baseline), Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 12), Visit 6 (Week 16), Visit 7 (Week 20), Visit 8 (Week 24), Visit 9 (Week 28), Visit 10 (Week 32), Visit 11 (Week 36), Visit 12 (Week 40), Visit 13 (Week 44)|Efficacy analysis population. Number of participants analyzed = number of participants evaluable for this outcome.||millimeters||Standard Deviation|Mean
697948|NCT01362062|Secondary|Participant's Global Assessment of Disease Activity Using VAS: Mean Change From Baseline at Every Visit|The participant's global assessment of disease activity is assessed on a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, and is described as “maximum disease activity” (maximum arthritis disease activity). A negative change from baseline indicated improvement.|Visit 2 (Baseline), Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 12), Visit 6 (Week 16), Visit 7 (Week 20), Visit 8 (Week 24), Visit 9 (Week 28), Visit 10 (Week 32), Visit 11 (Week 36), Visit 12 (Week 40), Visit 13 (Week 44)|Efficacy analysis population. Number of participants analyzed = number of participants evaluable for this outcome.||millimeters||Standard Deviation|Mean
697949|NCT01362062|Secondary|Change From Baseline in C-Reactive Protein (CRP) Levels at Every Visit||Visit 2 (Baseline), Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 12), Visit 6 (Week 16), Visit 7 (Week 20), Visit 8 (Week 24), Visit 9 (Week 28), Visit 10 (Week 32), Visit 11 (Week 36), Visit 12 (Week 40), Visit 13 (Week 44)|Efficacy analysis population. Number of participants analyzed = number of participants evaluable for this outcome.||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
697950|NCT01362062|Secondary|Change From Baseline (CFB) in ESR Values at Every Visit||Visit 2 (Baseline), Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 12), Visit 6 (Week 16), Visit 7 (Week 20), Visit 8 (Week 24), Visit 9 (Week 28), Visit 10 (Week 32), Visit 11 (Week 36), Visit 12 (Week 40), Visit 13 (Week 44)|Efficacy analysis population. Number of participants analyzed = number of participants evaluable for this outcome.||mm/hour||Standard Deviation|Mean
697951|NCT01362062|Secondary|Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50, ACR70 and ACR90 Responses at Every Visit|ACR20/ACR50/ACR70/ACR 90 response: greater than or equal to (≥) 20%/50%/70%/90% improvement in tender and swollen joint counts and 20%/50%/70%/90% improvement in 3 of the following 5 criteria: 1) Physician's global assessment of disease activity, 2) Participant assessment of disease activity, 3) Participant assessment of pain (VAS), 4) participant assessment of functional disability via a Health Assessment Questionnaire (HAQ), and 5) ESR at each visit.|Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 12), Visit 6 (Week 16), Visit 7 (Week 20), Visit 8 (Week 24), Visit 9 (Week 28), Visit 10 (Week 32), Visit 11 (Week 36), Visit 12 (Week 42), Visit 13 (Week 44)|Efficacy analysis population. Number of participants analyzed = number of participants evaluable for this outcome and n = number of participants evaluable at the specified time point.||percentage of participants|||Number
697952|NCT01362062|Secondary|Time Taken to Achieve Remission (DAS28 <2.6 Units)|DAS28 was calculated from the TJC of 28 joints, SJC of 28 joints, ESR (in mm/hour), and the participant's global assessment of disease activity (100 mm VAS: 0 mm=no disease activity to 100 mm=maximum disease activity). The formula for calculating DAS28 score using ESR value is: 0.56*√(TJC) + 0.28*√(SJC) + 0.70*log natural (ESR) + 0.014*global assessment of disease activity (100 mm VAS). Remission is defined as DAS28 value of <2.6 units at the time of assessment. Time taken to achieve remission is reported.|Up to 12 months|Efficacy analysis population. Number of participants analyzed = number of participants evaluable for this outcome.||days||Full Range|Mean
697953|NCT01362062|Secondary|Percentage of Participants Achieving Remission (DAS28 <2.6 Units) at Every Visit|DAS28 was calculated from the TJC of 28 joints, SJC of 28 joints, ESR (in mm/hour), and the participant's global assessment of disease activity (100 mm VAS: 0 mm=no disease activity to 100 mm=maximum disease activity). The formula for calculating DAS28 score using ESR value is: 0.56*√(TJC) + 0.28*√(SJC) + 0.70*log natural (ESR) + 0.014*global assessment of disease activity (100 mm VAS). Remission is defined as DAS28 value of <2.6 units at the time of assessment.|Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 12), Visit 6 (Week 16), Visit 7 (Week 20), Visit 8 (Week 24), Visit 9 (Week 28), Visit 10 (Week 32), Visit 11 (Week 36), Visit 12 (Week 40), Visit 13 (Week 44)|Efficacy analysis population. Number of participants analyzed = number of participants evaluable for this outcome and n = number of participants evaluable at the specified time point.||percentage of participants|||Number
697954|NCT01362062|Secondary|Time Required to Achieve Low Disease Activity (DAS28 <3.2 Units)|DAS28 was calculated from the TJC of 28 joints, SJC of 28 joints, ESR (in mm/hour), and the participant's global assessment of disease activity (100 mm VAS: 0 mm=no disease activity to 100 mm=maximum disease activity). The formula for calculating DAS28 score using ESR value is: 0.56*√(TJC) + 0.28*√(SJC) + 0.70*log natural (ESR) + 0.014*global assessment of disease activity (100 mm VAS). The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. Low disease activity is defined as decrease in DAS28 to a value <3.2 Units at the time of assessment. Time taken to achieve low disease activity was reported.|Up to 12 months|Efficacy analysis population. Number of participants analyzed = number of participants evaluable for this outcome.||days||Full Range|Mean
698219|NCT01358864|Secondary|Virological Response After 24 Weeks of Treatment Discontinuation (SVR24)|Percentage of participants with virological response after 24 weeks of treatment discontinuation (SVR24) defined as plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level <25 IU/mL (undetected) 24 weeks after the originally planned treatment duration.|24 weeks post treatment, up to 72 weeks|FAS||percentage of participants||95% Confidence Interval|Number
697955|NCT01362062|Secondary|Percentage of Participants Achieving Low Disease Activity (DAS28 Less Than [<] 3.2 Units) at Every Visit|DAS28 was calculated from the TJC of 28 joints, SJC of 28 joints, ESR (in mm/hour), and the participant's global assessment of disease activity (100 mm VAS: 0 mm=no disease activity to 100 mm=maximum disease activity). The formula for calculating DAS28 score using ESR value is: 0.56*√(TJC) + 0.28*√(SJC) + 0.70*log natural (ESR) + 0.014*global assessment of disease activity (100 mm VAS). The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. Low Disease Activity is defined as DAS28 value of <3.2 Units at the time of assessment.|Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 12), Visit 6 (Week 16), Visit 7 (Week 20), Visit 8 (Week 24), Visit 9 (Week 28), Visit 10 (Week 32), Visit 11 (Week 36), Visit 12 (Week 40), Visit 13 (Week 44)|Efficacy analysis population. Number of participants analyzed = number of participants evaluable for this outcome and n = number of participants evaluable at the specified time point.||percentage of participants|||Number
697956|NCT01362062|Secondary|Time Required to Achieve Clinically Meaningful Improvement in DAS28 (Reduction of At Least 1.2 Units)|DAS28 was calculated from the TJC of 28 joints, SJC of 28 joints, ESR (in mm/hour), and the participant's global assessment of disease activity (100 mm VAS: 0 mm=no disease activity to 100 mm=maximum disease activity). The formula for calculating DAS28 score using ESR value is: 0.56*√(TJC) + 0.28*√(SJC) + 0.70*log natural (ESR) + 0.014*global assessment of disease activity (100 mm VAS). The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A reduction of at least 1.2 units of DAS28 score from previous visit is considered as clinically meaningful improvement. Time taken to achieve clinically meaningful improvement in DAS28 was reported.|Up to 12 months|Efficacy analysis population. Number of participants analyzed = number of participants evaluable for this outcome.||days||Full Range|Mean
697957|NCT01362062|Secondary|Percentage of Participants Achieving a Clinically Meaningful Improvement in Disease Activity Score 28 (DAS28) (Reduction of At Least 1.2 Units) at Every Visit|DAS28 was calculated from the tender joint count (TJC) of 28 joints, swollen joint count (SJC) of 28 joints, erythrocyte sedimentation rate (ESR) (in millimeters [mm]/hour), and the participant's global assessment of disease activity (100 mm visual analog scale [VAS]: 0 mm=no disease activity to 100 mm=maximum disease activity). The formula for calculating DAS28 score using ESR value is: 0.56*square root (√) of TJC + 0.28*√(SJC) + 0.70*log natural (ESR) + 0.014*global assessment of disease activity (100 mm VAS). The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A reduction of at least 1.2 units of DAS28 score from previous visit is considered as clinically meaningful improvement.|Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 12), Visit 6 (Week 16), Visit 7 (Week 20), Visit 8 (Week 24), Visit 9 (Week 28), Visit 10 (Week 32), Visit 11 (Week 36), Visit 12 (Week 40), Visit 13 (Week 44)|Efficacy analysis population included participants who were observed prospectively in this study. Number of participants analyzed = number of participants evaluable for this outcome and n = number of participants evaluable at the specified time point.||percentage of participants|||Number
697958|NCT01362062|Primary|Percentage of Participants With Adverse Events (AEs) or Serious AEs (SAEs)|An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal product. An AE is considered as an SAE if it fulfills one of the following criteria: a) fatal or life-threatening, b) requires in-patient hospitalization or prolongation of existing hospitalization, c) results in a persistent or significant disability, d) results in a congenital abnormality/birth defect, e) is medically significant. AEs included serious as well as non-serious AEs.|Up to 12 months|Safety analysis population: Included all participants who received at least 1 dose of study drug.||percentage of participants|||Number
697959|NCT01362049|Secondary|Change From Baseline in Fear Avoidance Belief Questionnaire (Physical Activity Subscale 0-24 Points)|fear-avoidance beliefs about physical activity Scale for Physical Activity 0-24; sum items 2, 3, 4, 5. Higher score indicates higher fear beliefs about physical acitivty|Baseline and 12 months|Participants with available data are included||units on a scale||Standard Deviation|Median
697960|NCT01362049|Secondary|Change From Baseline in Fear Avoidance Belief Questionnaire (Physical Activity Subscale 0-24 Points)|fear-avoidance beliefs about physical activity Scale for Physical Activity 0-24; sum items 2, 3, 4, 5. Higher score indicates higher fear beliefs about physical acitivty|Baseline and 7 weeks|Participants with available data are included||units on a scale||Standard Deviation|Mean
697961|NCT01362049|Secondary|Change From Baseline in SF-36 Health Survey (0-100 Points)|Quality of Life - Physical Component Scale: 0-100 Higher score defines a more favorable health state|Baseline and 12 months|Participants with available data are included||units on a scale||Standard Deviation|Mean
697962|NCT01362049|Secondary|Change From Baseline in SF-36 Health Survey (0 - 100 Points)|Quality of Life - Physical Component Scale: 0-100 Higher score defines a more favorable health state|Baseline and 7 weeks|Participants with available data are included||units on a scale||Standard Deviation|Mean
697963|NCT01362049|Primary|Change From Baseline in Numeric Pain Rating Scale (0-10 Points)|Current Pain Scale 0-10 Lower score is better/improved|Baseline and 12 months|Participants with available data are included||units on a scale||Standard Deviation|Mean
697964|NCT01362049|Primary|Change From Baseline in Numeric Pain Rating Scale (0-10 Points)|Current Pain Scale 0-10 Lower score is better/improved|Baseline and 7 weeks|Participants with available data are included||units on a scale||Standard Deviation|Mean
697965|NCT01362049|Primary|Change From Baseline in Oswestry Disability Scale (0-100%)|Disability; Sacle 0-100% Lower score is considered better/improved|Baseline and 12 Months|Participants with available data are included||units on a scale||Standard Deviation|Mean
697966|NCT01362049|Primary|Change From Baseline in Oswestry Disability Scale (0-100%)|Disability; Sacle 0-100% Lower score is considered better/improved|Baseline and 7 weeks|Participants with available data are included||units on a scale||Standard Deviation|Mean
697967|NCT01361867|Secondary|Step Height Adaptation|The percentage of the step height change caused by the mechanical perturbation that subjects compensate for|within a trial of the experiment (i.e. a few minutes)|||% step height compensated for||Standard Error|Mean
697968|NCT01361867|Primary|Step Length Adaptation|The percentage of the step length change caused by the mechanical perturbation that subjects compensate for|within a trial of the experiment (i.e. a few minutes)|||% of step length compensated for||Standard Error|Mean
704368|NCT00098956|Secondary|Duration of Responses||From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 5 years||||||
697978|NCT01361633|Primary|California Verbal Learning Test-II (CLVT-II)|The CLVT-II is an assessment of verbal learning and memory which measures recall and recognition scores, encoding strategies, learning rates and error types. A list learning task with 16 words from 4 semantic categories are read over a series of 5 list presentations. Recall is assessed after learning and at a 20-minute delay. Software produces a report that computes raw and standardized scores. Our dependent variable was the age adjusted t-score for total number of words recalled after 5 trials. A higher score indicated better recall. The maximum possible score was 80 and a minimum was 0.|Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without patient follow up. Scores for the experimental and control group were compared.|||age adjusted t-scores||Standard Deviation|Mean
697979|NCT01361620|Primary|Whole Blood Coagulation|Whole blood coagulation after stimulation with arachidonic acid, as measured in the VerifyNow Aspirin system (Accumetrics). Aspirin response units (ARU) are the residual coagulation present in patients taking aspirin. The higher the ARU, the greater residual coagulation (resistance) to the aspirin effect.|Single measurement at 7-10 days after beginning aspirin|||Aspirin response units (ARU)||Standard Deviation|Mean
697980|NCT01361594|Secondary|Cerebrovascular Events|permanent stroke and reversible ischemic neurologic deficit|within 3 months after discharge||||||
697981|NCT01361594|Secondary|Pneumonia (CDC Criteria)|Pneumonia (CDC criteria)|Within 3 months after discharge||||||
697982|NCT01361594|Secondary|Surgical Wound Infection|Superficial and deep sternal wound infection|within 3 months after discharge||||||
697983|NCT01361594|Secondary|Major Cardiovascular Events|"Acute myocardial infarction : (1) typical increase and gradual decrease (troponin) or (2) more rapid increase and decrease (creatine kinase MB) of biochemical markers of myocardial necrosis with at least one of the following: (a) ischemic symptoms, (b) development of pathologic Q waves on the electrocardiogram, (c) electrocardiographic changes indicative of ischemia (ST-segment elevation or depression), or (d) coronary artery intervention (e.g., coronary angioplasty).
Congestive heart failure
Cardiac arrhythmias: malignant arrhythmia"|within 3 months after discharge||||||
697984|NCT01361594|Secondary|Measures of Inflammation|Measures of inflammation (C-reactive protein, TNF-alpha; IL-6) and oxidative stress markers|average 1 month during the hospitalization||||||
697985|NCT01361594|Secondary|Incidence of Organ Failures Assessed by the Daily SOFA Score|Incidence of organ failures assessed by the daily SOFA score|average 1 month during the hospitalization||||||
697986|NCT01361594|Secondary|Number of Hospital Readmissions and Emergency Room Visits|Number of hospital readmissions and emergency room visits|Within 30 days after discharge||||||
697987|NCT01361594|Secondary|Thirty Day Mortality|Thirty day mortality|within 30 days of discharge||||||
697988|NCT01361594|Secondary|Duration of Ventilatory Support and ICU Readmission|Duration of ventilatory support and ICU readmission|average 1 month during the hospitalization||||||
697989|NCT01361594|Primary|Hospital Mortality|Mortality is defined as death occurring during admission, either during ICU or after transition to non-ICU admission.|average 1 month during the hospitalization|||participants|||Number
697990|NCT01361594|Secondary|Cerebrovascular Events|permanent stroke and reversible ischemic neurologic deficit.|average 1 month during the hospitalization||||||
697991|NCT01361594|Secondary|Pneumonia (CDC Criteria)|Pneumonia (CDC criteria)|average 1 month during the hospitalization||||||
697992|NCT01361594|Secondary|Surgical Wound Infection|superficial and deep sternal wound infection|average 1 month during the hospitalization||||||
697993|NCT01361594|Secondary|ICU and Hospital Length of Stay, and ICU Readmissions|ICU and hospital length of stay, and ICU readmissions|average 1 month during the hospitalization||||||
697994|NCT01361594|Secondary|Respiratory Failure, Defined as PaO2 Value < 60 mm Hg While Breathing Air or a PaCO2 > 50 mm Hg.|Respiratory failure, defined as PaO2 value < 60 mm Hg while breathing air or a PaCO2 > 50 mm Hg.|average 1 month during the hospitalization||||||
697995|NCT01361594|Secondary|Acute Renal Failure|new-onset abnormal renal function: serum creatinine > 2.0 mg/dL or an increment level > 50% from baseline|average 1 month during the hospitalization||||||
697996|NCT01361594|Secondary|Major Cardiovascular Events|"Acute myocardial infarction : (1) typical increase and gradual decrease (troponin) or (2) more rapid increase and decrease (creatine kinase MB) of biochemical markers of myocardial necrosis with at least one of the following: (a) ischemic symptoms, (b) development of pathologic Q waves on the electrocardiogram, (c) electrocardiographic changes indicative of ischemia (ST-segment elevation or depression), or (d) coronary artery intervention (e.g., coronary angioplasty).
Congestive heart failure
Cardiac arrhythmias: malignant arrhythmia"|average 1 month during the hospitalization||||||
697997|NCT01361594|Secondary|Glycemic Control|"Hyperglycemic events (BG > 200 mg/dL) in ICU and non-ICU
Hypoglycemic events (BG < 70 mg/dl; severe hypoglycemia (BG < 40 mg/dl)."|average 1 month during the hospitalization||||||
697998|NCT01361594|Primary|Number of Subjects That Were Diagnosed for Peri-operative Complications|Number of participants that presented at least 1 complications including sternal wound infection, bacteremia, acute renal failure, respiratory failure, and major cardiovascular events (MACE) during the current hospitalization and up to 6 months after hospitalization|Within 6 months of hospitalization|||participants|||Number
697999|NCT01361568|Secondary|Total Number of Patients Reporting At Least One Episode of Vomiting||Up to 24 hours|All patients in the modified Intent-to-Treat (mITT) population and compared patients that received any dose of CR845 (preoperatively and/or postoperatively) to patients that only received placebo.||percentage of patients|||Number
698000|NCT01361568|Secondary|Total Number of Patients Reporting At Least One Episode of Nausea||Up to 24 hours|All patients in the modified Intent-to-Treat (mITT) population and compared patients that received any dose of CR845 (preoperatively and/or postoperatively) to patients that only received placebo.||percentage of patients|||Number
698001|NCT01361568|Secondary|Global Evaluation Responder Analysis|"Responders = Excellent or Very Good; Non-Responders = Fair or Poor. Patient who reported a score of Good were not included in the analysis as the midpoint cannot be unambiguously assigned for a binary outcome measurement."|At 24 hours|The responder analysis included all patients in the modified Intent-to-Treat (mITT) population and compared patients that received any dose of CR845 (preoperatively and/or postoperatively) to patients that only received placebo.||Responder Count|||Number
704369|NCT00098956|Secondary|Stable Disease Rate Evaluated Using RECIST Criteria||Up to 5 years|||participants|||Number
698002|NCT01361568|Secondary|Total Pain Relief Within the First 2 Hours (TOTPAR 0-2) Following Postoperative Study Drug Treatment Using LOCF|"Patients reported their pain relief using a 5-point categorical scale of 0 to 4 (0 = No Relief, 1 = A Little Relief, 2 = Some Relief, 3 = A Lot of Relief and 4 = Complete Relief). TOTPAR 0-2 was represents the cumulative time-weighted sum of the pain relief (PR) scores between each assessment timepoint following the postoperative administration of study drug (i.e. 15 to 30 min, 30 to 45 min, etc.) over the first 2 hours. Pain relief assessments were measured at 15, 30, 45, 60, 90, 120 minutes after the start of the infusion of study drug following surgery.
Positive TOTPAR values represent an increase in pain relief."|0 to 2 hours|The analysis included all patients in the modified Intent-to-Treat (mITT) population who re-randomized in the postoperative period, where time 0 was the start time of the postoperative study drug infusion, and did not have a missing baseline pain intensity score.||units on a scale * hours||Standard Error|Mean
698003|NCT01361568|Secondary|Morphine Consumption Following Postoperative Study Drug Treatment in the 2-24 Hour Period After Recovery in the Post-Anesthesia Care Unit (Post-PACU)||2 to 24 hours (post-PACU)|The analysis included all patients in the modified Intent-to-Treat (mITT) population who re-randomized in the postoperative period, where time 0 was the start time of the postoperative study drug infusion. Morphine consumption was calculated for the 2-24 hour period, after patients were transferred out of the PACU.||mg||Standard Error|Mean
698004|NCT01361568|Secondary|Summed Pain Intensity Difference From 0-24 Hours (SPID 0-24) Following Postoperative Study Drug Treatment Using Last Observation Carried Forward (LOCF)|"Patients reported their pain intensity using a visual analogue scale (VAS) from 0 to 100 mm, where 0 mm represented No Pain and 100 mm represented the Worst Pain You Can Imagine. SPID 0-24 represents the cumulative time-weighted sum of the pain intensity difference (PID) scores between each assessment timepoint following the postoperative administration of study drug (i.e. 0 to 15 min, 15 to 30 min, etc.) over 24 hours. Pain intensity assessments were measured at baseline (entry pain score), then at 15, 30, 45, 60, 90, 120, 150, 180, 240, 360, 480, 720, 960, and 1440 minutes after the start of the infusion of study drug following surgery.
Negative SPID values represent a decrease in pain intensity (i.e. lower values indicate a greater reduction in pain)."|0 to 24 hours|The analysis included all patients in the modified Intent-to-Treat (mITT) population who re-randomized in the postoperative period, where time 0 was the start time of the postoperative study drug infusion, and did not have a missing baseline pain intensity score.||units on a scale * hours||Standard Error|Mean
698005|NCT01361568|Primary|Total Morphine Consumption in the First 24 Hours Following Postoperative Study Drug Treatment||24 hours|The primary analysis included all patients in the modified Intent-to-Treat (mITT) population who re-randomized in the postoperative period, where time 0 was the start time of the postoperative study drug infusion.||mg||Standard Error|Mean
698006|NCT01361464|Secondary|Number of Participants With Relapse Free Survival|Relapse-free survival is calculated from the date of documentation of complete remission/morphologic complete remission with incomplete blood count recovery (CR/CRi) until disease relapse or death from any cause.|7 months|All evaluable participants||participants|||Number
698007|NCT01361464|Secondary|Median 1-Year Survival Rate|Prior to the early discontinuation of the study (for not meeting the primary endpoint of at least 3 CR/CRi after 2 cycles), investigators had planned to calculate one year survival from Kaplan Meier estimates.|1 year|Evaluable participants at planned study completion date|||||
698008|NCT01361464|Secondary|Median Overall Survival (OS)|Overall survival is calculated from the first day of R115777 treatment and lasts until the date of death recorded on the case report form (CRF).|From first treatment through follow up period, an expected average of 12 months|All evaluable participants||months||95% Confidence Interval|Median
698009|NCT01361464|Primary|Complete Remission (CR) Rate|Complete Remission (CR) rate in Acute Myelogenous Leukemia (AML) patients prospectively selected for R115777R115777 (ZARNESTRA) treatment on the basis of a 2-gene signature (RASGRP1:APTX ratio) in bone marrow aspirates. AML Complete Remission: Bone marrow aspiration - Less than 5% leukemic blasts, Auer rods not detected; Peripheral blood counts - Absolute neutrophil count >/= 1,000/mm^3, Platelet count >/= 100,000/mm^3, Leukemic blasts not present; Blood-product transfusion independence; Absence of extramedullary leukemia.|From first treatment through follow up period, an expected average of 12 months|All evaluable participants||percentage of participants|||Number
698010|NCT01361308|Primary|Mean Change From Baseline in Hot Flash Severity at Week 4 and Week 12|"Subjects recorded the number of hot flashes per week using an electronic diary. Severity score for hot flashes for each subject was calculated as the sum of 2 times the number of moderate hot flashes, plus 3 times the number of severe hot flashes, divided by the total number of moderate and severe hot flashes.
Weekly Severity Score = (2•Fm +3•FS)/(Fm + FS) Daily Severity Score = {(2•F) m +3•FS)/(Fm + FS)}/7 Where, Fm= Frequency of Moderate Hot Flashes Fs = Frequency of Severe Hot Flashes The calculated severity score is reported below."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.||Hot Flash Severity score per day||Standard Deviation|Mean
698011|NCT01361308|Secondary|BMI Change From Baseline (kg/m2), Median|"Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary.
Assessment of the effect of Brisdelle compared with placebo on body mass index."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.||Change from baseline BMI kg/m2||Full Range|Median
698058|NCT01360840|Secondary|Pharmacokinetic Parameter: Clearance of Intravenously Administered EMD 525797 After First Dose (CL) and Clearance in Steady State of EMD52597 After Fifth Dose (CLss)|The apparent total body clearance of drug following intravenous administration (CL); The apparent total body clearance of drug at steady state following intravenous administration (CLss).|Cycle 1 (Week 1) and cycle 5 (Week 13): Day 1: pre-dose, End of Infusion (EOI), 4, 8, 24, 48, 96, 168, 336, and 504 hours after start of infusion; Cycles 3 and 4 (Weeks 7 and 10), Day 1: pre-dose; Cycle 7 (Week 19), Day 1: pre-dose and EOI|"Pharmacokinetic Analysis Set (PKA) included all the randomized subjects who received at least the first dose of the trial drug and provided sufficient data for a concentration time profile for EMD 525797. n signifies the number of subjects evaluable for each category in the evaluated group, respectively."||Liter per hour||Standard Deviation|Mean
698012|NCT01361308|Secondary|Assessment of Mood|"Mood was measured by using the Profile of Mood States (POMS) questionnaire. The Profile of Moods States (POMS) is a 65-item multi-dimensional measure that provides a method of assessing transient, fluctuating active mood states. Key areas that are measured include: tension-anxiety, anger-hostility, fatigue-inertia, depression-dejection, vigor-activity, confusion-bewilderment. Responses to questions are scored with the following numerical values: Not at all = 1, A little = 2, Moderate = 3, Quite a bit = 4, Extremely = 5. A total score for a domain was obtained by summing the responses of individual items in the domain. The total POMS score can range from 65 to 325. Each subject’s total POMS score at baseline and at Week 4 and Week 12 were used to calculate the percent of participants with less disturbance in mood at Week 4 and Week 12 compared to baseline. The percent of participants with less disturbance in mood is reported below."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.||Percent of participants|||Number
698013|NCT01361308|Secondary|Effect of Brisdelle (Paroxetine Mesylate) Capsules on Anxiety and Depression|"Depression & anxiety were measured by using the Hospital Anxiety & Depression Scale (HADS).
The HADS was developed to assess anxiety & depression. It is meant to differentiate symptoms of depression with those of anxiety.
Number of items: 14 (7 questions relating to anxiety; 7 questions relating to depression).
Responses are based on the relative frequency of symptoms over the past week, using a four point scale ranging from 0 (not at all) to 3 (very often indeed).
Responses are summed to provide separate scores for anxiety and depression symptomology with possible scores ranging from 0 to 21 for each scale.
The results presented below are the percentage of participants with abnormal HADS Scores for both Abnormal Anxiety & Abnormal Depression at Week 4 and Week 12."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.||Percentage of participants|||Number
698014|NCT01361308|Secondary|Percent Responders Improvement in VMS From Baseline Using the Clinical Global Impression (CGI) Scale.|"Proportion of NRS Responders: Subject’s overall improvement in VMS from Baseline was assessed using the Numerical Rating Scale (NRS)
The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.
Responders: Subjects Achieving a Score of “Very Much Improved” Or “Much Improved” Or “Minimally Improved”.
Non Responders: Subjects with a Score of “No Change” Or “Minimally Worse” Or “Much Worse” Or “Very Much Worse”."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.||percentage of participants|||Number
698015|NCT01361308|Secondary|Effect of Paroxetine Mesylate Capsules on Percent Improvement of Hot Flash Interference From Baseline at Week 4 and Week 12, Hot Flash Related Daily Interference Scale (HFRDIS)|"Interference of hot flashes was measured by using the hot flash-related daily interference scale (HFRDIS). The HFRDIS is a 10-item scale that measures the degree to which hot flashes interfere with 9 daily activities and the tenth item measures the degree to which hot flashes interfere with each of the other items. Subjects can score for each item on a scale from 0 to 10 where 0 = Do not interfere and a score of 10 = Completely interferes.
The measure being reported below is percentage of responders who had an improvement in HFRDIS score at Week 4 and Week 12 compared to baseline. A responder is defined as a subject who had an improvement in the HFRDIS score. An improvement is defined as a score ≤3 on each question."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.||Percent of participants|||Number
698016|NCT01361308|Secondary|Change From Baseline in Arizona Sexual Experience Scale (ASEX, Week 4 and Week 12) Total Score|"The Arizona Sexual Experiences Scale (ASEX) is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm. Possible total scores range from 5 to 30, with the higher scores indicating more sexual dysfunction.
The sum of the scores for all 5 items was calculated at Week 4 and Week 12. The results presented below are change from baseline at Week 4 and Week 12."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.||units on a scale||Standard Deviation|Mean
698017|NCT01361308|Secondary|Percent Daytime and Nighttime Responders, Numerical Rating Scale (NRS)|"Subject’s overall improvement in VMS from Baseline assessed using the Numerical Rating Scale (NRS) The NRS is measured on a scale of 0 to 10 on how bothered the subject was by her VMS (0=not bothered at all and 10=very much bothered).
The measure being reported below is percentage of responders who had an improvement in NRSscore at Week 4 and Week 12 compared to baseline. A responder is defined as a subject who had an improvement in the NRS score. An improvement is defined as a score ≤5 on each question."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.||percentage of participants|||Number
698139|NCT01360450|Primary|Time to Complete Detoxification|Time to complete detoxification is defined as 48 hrs off all opioids/benzodiazepines and study drug with acceptable withdrawal scores of <9 (on average we expect the infant to be enrolled in the study for 2-4 weeks). The scale used to assess withdrawal was the Modified Finnegan Neonatal Withdrawal Scale, which ranges from 0-41, 0 represents no withdrawal and 41 represent maximum withdrawal.|up to 4 weeks|||days||Standard Deviation|Mean
698018|NCT01361308|Secondary|Percentage of Patient Global Improvement (PGI) Scale Responders (%)|"Percentage of PGI Responders: Subject’s overall improvement in VMS from baseline assessed using the Patient Global Improvement (PGI) scale. Responders: Subjects Achieving a Score of “Very Much Better” Or “Much Better” Or “A Little Better”.
Non Responders: Subjects with a Score of “No Change” Or “A Little Worse” Or “Much Worse” Or “Very Much Worse”.
Patient Global Improvement (PGI) scale is described below:
Compared to before starting study medication, how would you describe your hot flushes now? 0 = Not assessed
= Very much better
= Much better
= A little better
= No change
= A little worse
= Much worse
= Very much worse"|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.||percentage of participants|||Number
698019|NCT01361308|Secondary|Percentage of Responders|Participants reported the number of hot flashes using an electronic diary. Participants who hd a ≥50% reduction in hot flash frequency were defined as responders. The percent of responders is presented below.|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.||percentage of participants|||Number
698020|NCT01361308|Secondary|Change From Baseline in Greene Climacteric Scale (GCS) at Week 4 and Week 12, Total Score, Median|"The Greene Climacteric Scale (GCS) was used for this measurement. The scale has 21 questions and measures symptoms in 4 areas; these are psychological (anxiety and depression), physical, vasomotor, and libido.
The severity of the symptom was scored as: 0=none, 1=mild, 2=moderate, and 3=severe. Anxiety was determined by using the sum of scores 1 to 6, and depression was determined by using the sum of scores 7 to 11. Physical aspects were determined by using the sum of scores 12 to 18; vasomotor aspects were determined by using the sum of scores 19 to 20; and libido was determined by using the score for question 21.
The total GCS score ranges from 0 to 63 which is the sum of all the scores for the 21-symptom assessment questions in this scale. Each subject’s total GCS score at baseline and at Week 4 and Week 12 were used to calculate change from baseline in these symptoms. The change from baseline is reported below."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.||units on a scale||Full Range|Median
698021|NCT01361308|Secondary|Change in Severity of Moderate to Severe Hot Flashes From Baseline (BMI ≥32 kg/m2, Week 4 and Week 12), Median|"Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary.
For the BMI ≥32 kg/m2 subgroup, the mean weekly reduction in the severity of moderate to severe hot flashes from Baseline was calculated at Week 4 and Week 12.
Subjects recorded the number of hot flashes per week using an electronic diary. Severity score for hot flashes for each subject was calculated as the sum of 2 times the number of moderate hot flashes, plus 3 times the number of severe hot flashes, divided by the total number of moderate and severe hot flashes.
Weekly Severity Score = (2•Fm +3•FS)/(Fm + FS) Daily Severity Score = {(2•F) m +3•FS)/(Fm + FS)}/7 Where, Fm= Frequency of Moderate Hot Flashes Fs = Frequency of Severe Hot Flashes The calculated severity score is reported below."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.||Hot Flash Severity scores per week||Full Range|Median
698022|NCT01361308|Secondary|Change in Severity of Moderate to Severe Hot Flashes From Baseline (BMI <32 kg/m2, At Week 4 and Week 12), Median|"Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary.
For the BMI <32 kg/m2 subgroup, the mean weekly reduction in the severity of moderate to severe hot flashes from Baseline was calculated at Week 4 and Week 12.
Subjects recorded the number of hot flashes per week using an electronic diary. Severity score for hot flashes for each subject was calculated as the sum of 2 times the number of moderate hot flashes, plus 3 times the number of severe hot flashes, divided by the total number of moderate and severe hot flashes.
Weekly Severity Score = (2•Fm +3•FS)/(Fm + FS) Daily Severity Score = {(2•F) m +3•FS)/(Fm + FS)}/7 Where, Fm= Frequency of Moderate Hot Flashes Fs = Frequency of Severe Hot Flashes The calculated severity score is reported below."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.||Hot Flash Severity scores per week||Full Range|Median
698023|NCT01361308|Secondary|Change in Frequency of Moderate to Severe Hot Flashes Frequency From Baseline (BMI ≥32 kg/m2, Week 4 and Week 12), Median|"Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary.
For the BMI ≥32 kg/m2 subgroup, the mean weekly reduction in frequency of moderate to severe hot flashes from Baseline was calculated for Week 4 and Week 12."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.||Hot flashes per week||Full Range|Median
698024|NCT01361308|Secondary|Change in Frequency of Moderate to Severe Hot Flashes Frequency From Baseline (BMI <32 kg/m2, Week 4 and Week 12), Median|"Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary.
For the BMI <32 kg/m2 subgroup, the mean weekly reduction in frequency of moderate to severe hot flashes from Baseline was calculated for Week 4 and Week 12."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.||Hot flashes per week||Full Range|Median
704370|NCT00098956|Primary|Objective Response Rates (Complete and Partial) Evaluated Using RECIST Criteria||Up to 5 years|||participants|||Number
698025|NCT01361308|Secondary|Change From Baseline in Total Number of Awakenings Due to Hot Flashes, Median|"Participants completed a electronic diary to report nightime awakenings. Subjects took study drug once daily at bedtime and they were instructed to complete daily hot flash and sleep diaries to record the number of hot flashes daily, the severity of each episode of hot flash and total number of awakenings due to hot flashes.
The diary data was used to evaluate and compare the treatment groups, on the change from baseline to Week 4 and Week 12, in the total number of awakenings due to hot flashes. The total number of awakenings due to hot flashes in the run-in period was used as baseline."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.||Nightime awakenings||Full Range|Median
698026|NCT01361308|Secondary|Clinical Meaningfulness Anchored to Patient Global Improvement (PGI-I) (%)|"A patient improvement scale questionnaire was used during participant visits.
The clinical meaningfulness of the observed treatment effect was demonstrated by performing the following analysis:
Subjects were categorized in to 2 groups (satisfied and unsatisfied). Based on a 7 point patient global impression (PGI) questionnaire which assesses the subject improvement in VMS. Subjects were considered satisfied with their treatment if their response to the question “Compared to before starting the study medication, how would you describe your hot flushes now?” is ‘Very much better’ (1) or ‘Much better’ (2) or ‘A little better’ (3) and will be considered unsatisfied if their response to the same question is ‘No change’ (4) or ‘A little worse’ (5) or ‘Much worse’ (6) or ‘Very much worse’ (7). Receiver Operator Curve (ROC) analysis was performed on the combined data.
Subjects who were satisfied with their treatment were considered to have a treatment effect with clinical meaningfulness"|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.||Percentage of satisfied participants|||Number
698027|NCT01361308|Primary|Mean Change in Frequency of Moderate to Severe VMS From Baseline at Week 4 and Week 12.|"Subjects recorded the number of hot flashes per week using an electronic diary. The results reported are not hot flashes per week.
The results reported are:
Mean Baseline frequency of moderate to severe VMS
Mean change in frequency of moderate to severe VMS from baseline to Week 4
Mean change in frequency of moderate to severe VMS from baseline to Week 12."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.||Hot flash per day||Standard Deviation|Mean
698028|NCT01361178|Primary|The Primary Outcome Will be the Total Number of Days With Pneumonia.|The primary outcome for this study will be the total number of days with pneumonia. Pneumonia will be defined by the presence of both clinical and radiographic criteria: fever (temperature ≥ 38oC), cough, dyspnea, purulent expectoration and/or changes in the previous characteristics of respiratory secretions; and chest X-ray or CT scan revealing a new or progressive alveolar or interstitial infiltrate or cavitation that could not be explained by any other noninfectious cause.|Up to two years post-transplant|||Number of days|||Number
698029|NCT01361126|Secondary|Breakthrough Bleeding Events|Number of breakthrough bleeding events (spontaneous bleeding events) requiring treatment per subject in subjects receiving prophylactic treatment regimen with rIX-FP|Week 9 to approximately Week 20|Per protocol population||Events per subject||Standard Deviation|Mean
698030|NCT01361126|Secondary|Clearance of a Single Dose of rIX-FP||Pre-dose and up to 14 days after rIX-FP infusion|PK population||mL/h/kg||Geometric Coefficient of Variation|Geometric Mean
698031|NCT01361126|Secondary|Incremental Recovery of rIX-FP at 30 Minutes Following Infusion of rIX-FP|Incremental recovery (IU/mL/IU/kg) is defined as FIX activity (IU/mL) obtained 30 minutes following infusion, per dose of (IU/kg) infusion. FIX activity was measured at a central laboratory using validated one-stage clotting method.|30 minutes after infusion|PK population||IU/dL/IU/kg||Geometric Coefficient of Variation|Geometric Mean
698032|NCT01361126|Secondary|Half-life (t1/2) of a Single Dose of rIX-FP||Pre-dose and up to 14 days after infusion|PK population||hours||Geometric Coefficient of Variation|Geometric Mean
698033|NCT01361126|Secondary|Area Under the Curve to the Last Sample With Quantifiable Drug Concentration (AUC0-t) After a Single Dose of rIX-FP|The plasma concentrations of rIX-FP were measured as FIX activity using a validated, 1-stage assay in a central laboratory for a quantification range from 0.25 to 150% (or 0.25 IU/dL to 150 IU/dL). The PK population comprised all subjects who received at least 1 dose of rIX-FP and for whom a sufficient number of analyzable PK samples had been obtained in order to permit the evaluation of the PK profile of rIX-FP, and who did not receive a dose of rIX-FP or any other FIX product for the treatment of a bleed during the PK sampling period.|Pre-dose and up to 14 days after rIX-FP infusion.|PK population||h*IU/dL||Geometric Coefficient of Variation|Geometric Mean
698034|NCT01361126|Primary|Number of Subjects Who Developed Antibodies to rIX-FP|Antibodies against rIX-FP were detected using a direct binding enzyme-linked immunosorbent assay (ELISA).|Pre-dose, Day 10 and Weeks 4, 12, and 20|Safety Population||participants|||Number
698035|NCT01361126|Primary|Number of Subjects With Inhibitors Against Factor IX (FIX)|The presence of inhibitors against FIX was assessed by the central laboratory by a FIX potency assay. To quantify anti-FIX neutralizing antibodies, the Bethesda assay with the Nijmegen modification was used, and the results expressed as Bethesda Units per mL (BU/mL). A positive inhibitor test is >=0.6 BU/mL.|Baseline, Day 10 and Weeks 4, 12 and 20|Safety Population||participants|||Number
698036|NCT01361126|Primary|Number of Subjects With Treatment-related Adverse Events|The causal relationship of each adverse event to rIX-FP was assessed by the Investigator.|Approximately 20 weeks|Safety Population||participants|||Number
698037|NCT01361113|Secondary|Exploratory Analysis of Objective Response and Recurrence Free Survival Rates|To preform and exploratory analysis of the objective response rate (OR) and recurrence free survival (RFS) rates in the evaluable group who receives 4-7 weeks of therapy separately from the evaluable group who receives 8 weeks of therapy.|1 year||||||
698243|NCT01358734|Secondary|Event-Free Survival (EFS)|EFS is defined as the interval from the date of randomization to the date of treatment failure, progressive disease, relapse after CR or CRi, or death from any cause, whichever occurs first|Up to 74 months||06/2019||||
698039|NCT01361113|Secondary|Number of Participants With Adverse Events Related to Treatment.|"Identify any safety issues in subjects treated with pazopanib, neoadjuvantly, followed by nephrectomy. Number of patients that had adverse events reported that had an attribution of; possible, probable, or definite that are graded a 3 or higher according to Common Terminology Criteria for Adverse Events (CTCAE v4.0).
Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.
Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age appropriate instrumental activities of daily living Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living.
Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to adverse event."|9 weeks|||Participants|||Count of Participants
698040|NCT01361113|Secondary|Altered Surgical Approach After Treatment With Pazopanib|Determine if neoadjuvant treatment with pazopanib alters the planned surgical approach of the urologist, per documented radiographic (CT) response.|14 weeks||||||
698041|NCT01361113|Secondary|Recurrence Free Survival (RFS)|Estimate recurrence free survival (RFS) following neoadjuvant treatment with pazopanib followed by nephrectomy, specifically reporting the 1 year and 2 year rate estimates with their 95% confidence intervals.|2 years||||||
698042|NCT01361113|Primary|Response Rate|"Determine the objective response rate (CR+PR) using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 at 8 weeks after neoadjuvant treatment with pazopanib in patients with locally advanced renal cell carcinoma.
Evaluation of Target Lesions using RECIST 1.1 Criteria:
Complete response (CR)−Disappearance of all target lesions. Any pathological lymph node (LN) target or no must have decreased in short axis to <10mm.
Partial response (PR)−At least a 30% decrease in the sum of the longest diameter (LD) of the target lesions taking as reference the baseline sum LD."|8 weeks after neoadjuvant treatment|||Participants|||Count of Participants
698043|NCT01361048|Secondary|Tolerability of the Study Product|any side effects?|day 12-15 day 30-35||||||
698044|NCT01361048|Primary|Percentage of Participants Cured of Vaginal Trichmonas|percentage of participants achieving microbiological cure of trichomonas|day 12-15|||percentage of participants|||Number
698045|NCT01361009|Secondary|The Dosage Related Information of Pramipexole at the End of Study|At the end of study, the distribution of patients in 3 pramipexole dosage categories.|12 weeks|There were 2017 patients in SAS set||percentage of patients|||Number
698046|NCT01361009|Secondary|The Dosage Related Information of Pramipexole at Baseline|At enrollment, the distribution of patients in 3 pramipexole dosage categories.|baseline|There were 2017 patients in SAS set.||percentage of patients|||Number
698047|NCT01361009|Secondary|Patient Global Impression(PGI) at Visit 1(Baseline) and Visit 3(at the End of Study)|Patient Global Impression (PGI) scale, ranging from 1 (excellent) to 7 (extremely poor), including 1(excellent), 2(very good), 3(good), 4(no change), 5(poor), 6(very poor) and 7(extremely poor).|Baseline (Visit 1) and 12 weeks (Visit 3)|There were 1891 patients in full analysis set(FAS). FAS includes all patients who fulfilled the inclusion criteria and exclusion criteria, without missing PGI values at visit 1 and visit 3. In the recruited 2017 patients, 116 patients didn't fully meet the inclusion or exclusion criteria and 10 patients missed PGI data at visit 1 or visit 3.||unit on a scale||Standard Deviation|Mean
698048|NCT01361009|Primary|Incidence of AE/SAE|The percentage of adverse events or serious adverse events occurring under Pramipexole mono- or combination therapy with other medication in this study.|12 weeks|There were 2017 patients in the safety analysis set (SAS). SAS includes the patients who took drug at least once and had safety data. In this study, 2017 patients were recruited, who have been using pramipexole before the enrollment.||Percentage of participants|||Number
698049|NCT01360996|Secondary|Oral Disposition Index|Post-treatment insulin secretion-sensitivity index (ISSI) calculated from the oral glucose tolerance test (OGTT). A higher value indicate improved carbohydrate metabolism|24 weeks|||calculated index||Standard Deviation|Mean
698050|NCT01360996|Secondary|Adrenal Androgen DHEAS|Post-treatment levels of adrenal androgen DHEAS|24 weeks|||micromol/L||Standard Deviation|Mean
698051|NCT01360996|Secondary|Menstrual Cycle Regularity|Post treatment menstrual frequency over 24 weeks normalized to number of menses per year ..|24 weeks|||number of cycles annually||Standard Deviation|Mean
698052|NCT01360996|Secondary|Biochemical Indicator of B-vitamin Status|Post-treatment in folate concentrations after 24 weeks of treatment|24 weeks|||Folate in nmol/l||Standard Deviation|Mean
698053|NCT01360996|Secondary|Post Therapy BMI.|Post-treatment body mass index at 24 weeks|24 weeks|||kg/m2||Standard Deviation|Mean
698054|NCT01360996|Secondary|Cardiometabolic Measures|Values represent blood pressure at 24 weeks.|24 weeks|||mmHg||Standard Deviation|Mean
698055|NCT01360996|Primary|Biochemical Assessment of Hyperandrogenism|"The primary outcome measure is post-treatment Free Androgen Index(FAI) which is expressed in units.
FAI is calculated by taking the testosterone concentration (in nmol/l) and dividing by concentration of sex hormone binding globulin (SHBG in nmol/L)and multiplying by 100"|24 weeks|||Index||Standard Deviation|Mean
698056|NCT01360840|Other Pre-specified|To Explore the Relationship Between Number and/or Changes of Numbers of Biomarker and the Clinical Outcome||From the date of randomization up to data cut-off date (30 April 2013), assessed up to 2 years|Data for this outcome measure was presented graphically as per planned analysis but not statistically summarized.|||||
698057|NCT01360840|Secondary|Pharmacokinetic Parameter: Volume of Distribution of EMD 525797 After the First Dose (V) and in Steady State After the Fifth Dose (Vss) of Intravenous Infusion|The apparent volume of distribution during the terminal phase following intravenous administration (V). The estimate of the apparent volume of distribution at steady state following intravenous administration (Vss).|Cycle 1 (Week 1) and cycle 5 (Week 13): Day 1: pre-dose, End of Infusion (EOI), 4, 8, 24, 48, 96, 168, 336, and 504 hours after start of infusion; Cycles 3 and 4 (Weeks 7 and 10), Day 1: pre-dose; Cycle 7 (Week 19), Day 1: pre-dose and EOI|"PKA included all the randomized subjects who received at least the first dose of the trial drug and provided sufficient data for a concentration time profile for EMD 525797. n signifies the number of subjects evaluable for each category in the evaluated group, respectively."||liter||Standard Deviation|Mean
698244|NCT01358734|Secondary|Progression-Free Survival (PFS)|PFS is defined as the time from randomization to the first observation of documented disease progression or death due to any cause whichever occurs first.|Up to 74 months||04/2019||||
698059|NCT01360840|Secondary|Number of Subjects With Any Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death, and TEAEs Leading to Discontinuation|An AE was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A serious adverse event was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs were defined as those AEs that started between first dose of study drug and up to 50 days after last dose.|From the first dose of study drug administration until 50 days after the last dose of study drug administration or until cut-off date (30 April 2013), assessed up to 2 years|The Safety analysis set included all the randomized subjects who received at least 1 dose of planned trial treatment and had at least one safety assessment following the trial treatment.||Subjects|||Number
698060|NCT01360840|Secondary|Overall Minimum Percentage Change From Previous Time Point in Circulating Tumor Cells (CTC)||Cycle 1, Day 1 (Week 1): pre-dose, Cycle 3, Day 1 (Week 7): pre-dose, and Cycle 5, Day 1 (Week 13): pre-dose|ITT analysis set included all the subjects who were randomized in the study. “N” signifies the total number of subjects evaluable for this outcome measure.||Percent change||Standard Deviation|Mean
698061|NCT01360840|Secondary|Minimum Percentage Change From Baseline in the Number of Circulating Tumor Cells (CTCs)||Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years|ITT analysis set included all the subjects who were randomized in the study. “N” signifies the total number of subjects evaluable for this outcome measure.||Percent change||Standard Deviation|Mean
698062|NCT01360840|Secondary|Minimum Percentage Change From Baseline in PSA Serum Concentration||Baseline, up to data cut-off date (30 April 2013), assessed up to 2 years|ITT analysis set included all the subjects who were randomized in the study. “N” signifies the total number of subjects evaluable for this outcome measure.||Percent change||Standard Deviation|Mean
698063|NCT01360840|Secondary|Number of Subjects With Presence of Prostate Specific Antigen (PSA) Response|PSA response was defined as a decrease greater than 50 percent (%) in PSA value from baseline for 2 consecutive evaluations greater than or equal to (>=) 3 Weeks apart.|Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years|ITT analysis set included all the subjects who were randomized in the study. “N” signifies the total number of subjects evaluable for this outcome measure.||Subjects|||Number
698064|NCT01360840|Secondary|Number of Subjects With Presence of Skeletal Related Events|Presence of skeletal related events was defined as cord compression or fracture documented via a scheduled or unscheduled radiographic assessment triggered by increased pain or other signs and/or symptoms at the investigator discretion. Non-radiological events, including emergency bone irradiation and surgery, were not investigated.|Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years|ITT analysis set included all the subjects who were randomized in the study.||Subjects|||Number
698065|NCT01360840|Secondary|Bone and Soft Tissue Lesions Composite Tumor Response|Bone and soft tissue lesions composite tumor response was defined as the presence of both a confirmed CR or PR, documented by CT scans, and a DC in bone lesions, documented by bone scintigraphy. CR was defined as disappearance of all target and non-target lesions and PR was defined as at least 30% decrease in the sum of the longest diameter of target lesions and non-complete response/non-progressive disease in non-target lesions. Presence of DC in bone lesions was defined as the appearance of less than 2 new bone lesions.|Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years|ITT analysis set included all the subjects who were randomized in the study.||Subjects|||Number
698066|NCT01360840|Secondary|Number of Subjects With Presence of DC in Bone Lesions|Presence of DC in bone lesions was defined as the appearance of less than 2 new bone lesions, documented by bone scintigraphy.|At Weeks 13, 19 and 25|ITT analysis set included all the subjects randomized in the study.||Subjects|||Number
698067|NCT01360840|Secondary|Number of Subjects With New Bone Lesions Compared to Baseline|New bone lesions were evaluated by bone scintigraphy for subjects with bone lesions at baseline.|Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years|ITT analysis set included all the subjects randomized in the study. “N” signifies the total number of subjects evaluable for this outcome measure.||Subjects|||Number
698068|NCT01360840|Secondary|Number of Subjects With Presence of Tumor Response and Disease Control (DC) in Soft Tissue Lesions|Presence of tumor response in soft tissue lesions was defined as the presence of at least 1 confirmed complete response (CR) or confirmed partial response (PR) in soft tissue lesions, documented by computed tomography (CT) scans. Presence of DC in soft tissue lesions was defined as the presence of at least 1 confirmed CR or confirmed PR or stable disease (SD) lasting at least 12 weeks after randomization. Tumor response assessments were based on RECIST v1.0 modified according to the PCWG-2. The response was evaluated for subjects with measurable disease at baseline. According to RECIST v1.0, CR=disappearance of all target and non-target lesions; PR=at least 30% decrease in the sum of the longest diameter of target lesions and non-complete response/non-progressive disease in non-target lesions.|Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years|"ITT analysis set included all the subjects who were randomized in the study. N signifies the total number of subjects evaluable for this outcome measure."||Subjects|||Number
698069|NCT01360840|Secondary|Time to Tumor Progression|Time to tumor progression was defined as the time from the date of randomization to the date of ORDP. ORDP was defined as: Bone lesion progression (2 or more new bone lesions compared to baseline) assessed with bone scintigraphy, which had to be confirmed by bone scintigraphy 6 weeks later if subjects remained asymptomatic or mildly symptomatic. Assessments were to be based on RECIST v1.0 modified according to PCWG-2; Soft-tissue lesion progression assessed with CT scans according to RECIST v1.0 modified as per PCWG-2; Presence of skeletal events defined as cord compression or fracture documented via a scheduled or unscheduled radiographic assessment triggered by increased pain or other signs and/or symptoms, based on the investigator’s discretion; Non-radiological events, including emergency bone irradiation and surgery, were not investigated.|Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years|ITT analysis set included all the subjects who were randomized in the study.||months||95% Confidence Interval|Median
698070|NCT01360840|Secondary|Overall Survival|Overall Survival was defined as the time from the date of randomization to the date of death from any cause.|Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years|ITT analysis set included all the subjects who were randomized in the study.||months||95% Confidence Interval|Median
698071|NCT01360840|Primary|Progression Free Survival (PFS) Time|PFS was defined as time from randomization until the first documented sign of objective radiographic disease progression (ORDP) or death from any cause. Death was considered as an event only if it was reported within 12 weeks after last tumor assessment without progression. ORDP was defined as: Bone lesion progression (2 or more new bone lesions compared to baseline) assessed with bone scintigraphy. Assessment was based on Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0) modified as per Prostate Cancer Working Group 2 (PCWG-2); Soft-tissue lesion progression assessed with CT scans according to RECIST v1.0 modified as per PCWG-2; Presence of skeletal events defined as cord compression/fracture documented via a scheduled or unscheduled radiographic assessment triggered by increased pain or other signs and/or symptoms, based on the investigator’s discretion; Non-radiological events, including emergency bone irradiation and surgery, were not investigated.|Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years|Intention-to-treat (ITT) analysis set included all the subjects who were randomized in the study.||months||95% Confidence Interval|Median
698072|NCT01360645|Secondary|Percentage of Participants With CGI-I Scale Response Rate at Week 14 Relative to Baseline (End of Phase A [Week 8]) for the Efficacy Sample Per the Final Protocol.|CGI-I response was defined as a CGI-I score of 1 (very much improved) or 2 (much improved).|Baseline and Week 14|All participants in the efficacy sample who met the revised randomization criteria for incomplete response as defined in protocol amendment 3. The LOCF data set included data recorded at a Phase B visit, if no observation was recorded, data was carried forward from the previous visit.||Percentage of participants|||Number
698073|NCT01360645|Secondary|Percentage of Participants With CGI-I Scale Response Rate at Week 14 Relative to Baseline (End of Phase A [Week 8]) for the Efficacy Sample.|CGI-I response was defined as a CGI-I score of 1 (very much improved) or 2 (much improved).|Baseline and Week 14|The Efficacy Sample comprised of all participants in the Safety Sample who had an end of Phase A (i.e, Week 8) value and at least one post-randomization efficacy evaluation for MADRS total score in Phase B. The LOCF data set included data recorded at a Phase B visit, if no observation was recorded, data was carried forward from the previous visit.||Percentage of participants|||Number
698074|NCT01360645|Secondary|Percentage of Participants With MADRS Remission at Week 14 Relative to Baseline (End of Phase A [Week 8]) for the Efficacy Sample Per the Final Protocol.|MADRS remission was defined as </=10 and >/=50% reduction in MADRS total score from end of Phase A (Week 8).|Baseline and Week 14|All participants in the efficacy sample who met the revised randomization criteria for incomplete response as defined in protocol amendment 3. The LOCF data set included data recorded at a Phase B visit, if no observation was recorded, data was carried forward from the previous visit.||Percentage of participants|||Number
698075|NCT01360645|Secondary|Percentage of Participants With MADRS Remission at Week 14 Relative to Baseline (End of Phase A [Week 8]) for the Efficacy Sample.|MADRS remission was defined as </=10 and >/=50% reduction in MADRS total score from end of Phase A (Week 8).|Baseline and Week 14|The Efficacy Sample comprised of all participants in the Safety Sample who had an end of Phase A (i.e, Week 8) value and at least one post-randomization efficacy evaluation for MADRS total score in Phase B. The LOCF data set included data recorded at a Phase B visit, if no observation was recorded, data was carried forward from the previous visit.||Percentage of participants|||Number
698076|NCT01360645|Secondary|Percentage of Participants With MADRS Response at Week 14 Relative to Baseline (End of Phase A [Week 8]) for the Efficacy Sample Per the Final Protocol.|The MADRS response was defined as >/=50% reduction in MADRS total score from end of Phase A (Week 8).|Baseline and Week 14|All participants in the efficacy sample who met the revised randomization criteria for incomplete response as defined in protocol amendment 3. The LOCF data set included data recorded at a Phase B visit, if no observation was recorded, data was carried forward from the previous visit.||Percentage of participants|||Number
698077|NCT01360645|Secondary|Percentage of Participants With MADRS Response at Week 14 Relative to Baseline (End of Phase A [Week 8]) for the Efficacy Sample.|The MADRS response was defined as >/=50% reduction in MADRS total score from end of Phase A (Week 8).|Baseline and Week 14|The Efficacy Sample comprised of all participants in the Safety Sample who had an end of Phase A (i.e, Week 8) value and at least one post-randomization efficacy evaluation for MADRS total score in Phase B. The LOCF data set included data recorded at a Phase B visit, if no observation was recorded, data was carried forward from the previous visit.||Percentage of participants|||Number
698078|NCT01360645|Secondary|Change From Baseline (End of Phase A [Week 8]) to Week 14 in HAM-A Rating Scale Total Score for the Efficacy Sample Per the Final Protocol.|The HAM-A is utilized for the evaluation of anxiety symptoms. The HAM-A consists of 14 items. Each item is rated on a 0 to 4 scale. For all of these items, 0 is the “best” rating and 4 is the “worst” rating. If no item scores are missing, then the HAM-A total score is the sum of all 14 item scores. The possible total scores are from 0 to 56, with higher scores indicating worse anxiety symptoms.|Baseline and Week 14|All participants in the efficacy sample who met the revised randomization criteria for incomplete response as defined in protocol amendment 3. The LOCF data set included data recorded at a Phase B visit, if no observation was recorded, data was carried forward from the previous visit.||Units on a scale||Standard Error|Least Squares Mean
698079|NCT01360645|Secondary|Change From Baseline (End of Phase A [Week 8]) to Week 14 in Hamilton Anxiety (HAM-A) Rating Scale Total Score for the Efficacy Sample|The HAM-A is utilized for the evaluation of anxiety symptoms. The HAM-A consists of 14 items. Each item is rated on a 0 to 4 scale. For all of these items, 0 is the “best” rating and 4 is the “worst” rating. If no item scores are missing, then the HAM-A total score is the sum of all 14 item scores. The possible total scores are from 0 to 56, with higher scores indicating worse anxiety symptoms.|Baseline and Week 14|The Efficacy Sample comprised of all participants in the Safety Sample who had an end of Phase A (i.e, Week 8) value and at least one post-randomization efficacy evaluation for MADRS total score in Phase B. The LOCF data set included data recorded at a Phase B visit, if no observation was recorded, data was carried forward from the previous visit.||Units on a scale||Standard Error|Least Squares Mean
698176|NCT01359644|Primary|Percentage of Participants With Sustained Virologic Response at Post Treatment Week 12 (SVR12)|SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected (ie, HCV RNA <25 IU/mL) at follow-up Week 12. DCV=daclatasvir, SOF=sofosbuvir.|Follow-up Week 12|The analysis was performed in all treated participants who received at least 1 dose of active study therapy. The ‘n’ signifies those participants evaluable for this measure at specified time points for each group, respectively.||Percentage of participants|||Number
698080|NCT01360645|Secondary|Change From Baseline (End of Phase A [Week 8]) to Week 14 in HAM-D Rating Scale Total Score for the Efficacy Sample Per the Final Protocol.|The HAM-D (17-Item) consists of 17 items. Eight items are rated on a 0 to 2 scale (items 4, 5, 6, 12, 13, 14, 16 and 17), while nine items (items 1, 2, 3, 7, 8, 9, 10, 11, and 15) are rated on a 0 to 4 scale (twice the weight of the other items). For all of these items, 0 is the “best” rating and the highest score (2 or 4) is the “worst” rating. The sum of the scores from the first 17 items; 0-7 =Normal; 8-13 =mild depression; 14-18 =moderate depression; 19-22 =severe depression; ≥23 =very severe depression. The total score ranges from 0 to 52, with higher score indicating worse depressive symptoms.|Baseline and Week 14|All participants in the efficacy sample who met the revised randomization criteria for incomplete response as defined in protocol amendment 3. The LOCF data set included data recorded at Phase B visit, if no observation was recorded, data was carried forward from previous visit.||Units on a scale||Standard Error|Least Squares Mean
698081|NCT01360645|Secondary|Change From Baseline (End of Phase A [Week 8]) to Week 14 in Hamilton Depression (HAM-D) Rating Scale Total Score for the Efficacy Sample.|The HAM-D (17-Item) consists of 17 items. Eight items are rated on a 0 to 2 scale (items 4, 5, 6, 12, 13, 14, 16 and 17), while nine items (items 1, 2, 3, 7, 8, 9, 10, 11, and 15) are rated on a 0 to 4 scale (twice the weight of the other items). For all of these items, 0 is the “best” rating and the highest score (2 or 4) is the “worst” rating. The sum of the scores from the first 17 items; 0-7 =Normal; 8-13 =mild depression; 14-18 =moderate depression; 19-22 =severe depression; ≥23 =very severe depression. The total score ranges from 0 to 52, with higher score indicating worse depressive symptoms.|Baseline and Week 14|Efficacy Sample comprised all participants in Safety Sample who had end of Phase A value and at least one post-randomization efficacy evaluation for MADRS total score in Phase B. The Last-observation-carried-forward (LOCF) data set included data recorded at Phase B visit, if no observation was recorded, data was carried forward from previous visit.||Units on a scale||Standard Error|Least Squares Mean
698082|NCT01360645|Secondary|Change From Baseline (End of Phase A [Week 8]) in SDS Item Scores for the Efficacy Sample Per the Final Protocol.|The SDS is a self-rated instrument used to measure the effect of the patient’s symptoms on work/school, social life, and family/home responsibilities. For each of the three items, scores range from 0 through 10. The number most representative of how much each area was disrupted by symptoms is marked along the line from 0 = not at all, to 10 = extremely. For the work/school item, no response was to be entered if the patient did not work or go to school for reasons unrelated to the disorder and a response therefore not being applicable. The Mean SDS Score will be calculated over the three item scores. All three item scores need to be available with the exception of the work/school item score when this item is not applicable.|Week 11 and 14|All participants in the efficacy sample who met the revised randomization criteria for incomplete response as defined in protocol amendment 3.||Units on a scale||Standard Error|Least Squares Mean
698083|NCT01360645|Secondary|Change From Baseline (End of Phase A [Week 8]) in SDS Item Scores for the Efficacy Sample.|The SDS is a self-rated instrument used to measure the effect of the patient’s symptoms on work/school, social life, and family/home responsibilities. For each of the three items, scores range from 0 through 10. The number most representative of how much each area was disrupted by symptoms is marked along the line from 0 = not at all, to 10 = extremely. For the work/school item, no response was to be entered if the patient did not work or go to school for reasons unrelated to the disorder and a response therefore not being applicable. The Mean SDS Score will be calculated over the three item scores. All three item scores need to be available with the exception of the work/school item score when this item is not applicable.|Week 11 and 14|The Efficacy Sample comprised of all participants in the Safety Sample who had an end of Phase A (i.e, Week 8) value and at least one post-randomization efficacy evaluation for MADRS total score in Phase B.||Units on a scale||Standard Error|Least Squares Mean
698084|NCT01360645|Secondary|Change From Baseline (End of Phase A [Week 8]) to Week 14 in the IDS-SR Total Score for the Efficacy Sample Per the Final Protocol.|"The IDS-SR consists of 30 items, all rated on a 0 to 3 scale with 0 being the “best” rating and 3 being the “worst” rating. Besides item 9, two sub-items 9A and 9B exist, with possible scores of 1, 2 or 3 for item 9A, and 0 or 1 for item 9B. The scores for these two sub-items are not included in the calculation of the total score. Item 11 or item 12 should be completed but not both, and similarly, item 13 or item 14 should be completed but not both. Should items 11 and 12 be rated both, then the maximum of the two scores will be used. The same approach will be used for handling items 13 and 14.
The IDS-SR total score is the sum of ratings of 28 item scores. The possible IDS-SR total score ranges from 0 to 84."|Week 9, 10, 11, 12, 13, and 14|All participants in the efficacy sample who met the revised randomization criteria for incomplete response as defined in protocol amendment 3.||Units on a scale||Standard Error|Least Squares Mean
698085|NCT01360645|Secondary|Change From Baseline (End of Phase A [Week 8]) to Week 14 in the Inventory of Depressive Symptomatology (Self-Report) (IDS-SR) Total Score for the Efficacy Sample.|"The IDS-SR consists of 30 items, all rated on a 0 to 3 scale with 0 being the “best” rating and 3 being the “worst” rating. Besides item 9, two sub-items 9A and 9B exist, with possible scores of 1, 2 or 3 for item 9A, and 0 or 1 for item 9B. The scores for these two sub-items are not included in the calculation of the total score. Item 11 or item 12 should be completed but not both, and similarly, item 13 or item 14 should be completed but not both. Should items 11 and 12 be rated both, then the maximum of the two scores will be used. The same approach will be used for handling items 13 and 14.
The IDS-SR total score is the sum of ratings of 28 item scores. The possible IDS-SR total score ranges from 0 to 84."|Week 9, 10, 11, 12, 13, and 14|The Efficacy Sample comprised of all participants in the Safety Sample who had an end of Phase A (i.e, Week 8) value and at least one post-randomization efficacy evaluation for MADRS total score in Phase B.||Units on a scale||Standard Error|Least Squares Mean
698086|NCT01360645|Secondary|Change From Baseline (End of Phase A [Week 8]) to Week 14 in CGI-S Scale Score for the Efficacy Sample Per the Final Protocol.|Items on CGI-S scale are: 0 = not assessed, 1 = normal, not at all ill, 2 = borderline mentally ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill patients. The score 0 (= not assessed) will be set to missing. The CGI-S is therefore a 7-point scale from 1 through 7.|Week 9, 10, 11, 12, 13, and 14|All participants in the efficacy sample who met the revised randomization criteria for incomplete response as defined in protocol amendment 3.||Units on a scale||Standard Error|Least Squares Mean
721489|NCT00310310|Other Pre-specified|Self-Efficacy|"Social-cognitive theory (SCT) measure
1= Disagree Completely 5= Agree Completely 6= Not applicable"|1 month|||units on a scale||Standard Deviation|Mean
698087|NCT01360645|Secondary|Change From Baseline (End of Phase A [Week 8]) to Week 14 in Clinical Global Impression - Severity of Illness (CGI-S) Scale Score for the Efficacy Sample.|Items on CGI-S scale are: 0 = not assessed, 1 = normal, not at all ill, 2 = borderline mentally ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill patients. The score 0 (= not assessed) will be set to missing. The CGI-S is therefore a 7-point scale from 1 through 7.|Week 9, 10, 11, 12, 13, and 14|The Efficacy Sample comprised of all participants in the Safety Sample who had an end of Phase A (i.e, Week 8) value and at least one post-randomization efficacy evaluation for MADRS total score in Phase B.||Units on a scale||Standard Error|Least Squares Mean
698088|NCT01360645|Secondary|Mean CGI-I Scale Score (End of Phase A [Week 8]) to Week 14 by Trial Week for the Efficacy Sample Per the Final Protocol.|The items on CGI-I scale are: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse. The score of 0 (= not assessed) will be set to missing. The CGI-I is therefore a 7-point scale from 1 through 7. The CGI-I was measured in related to Baseline (Week 8).|Week 9, 10, 11, 12, 13, and 14|All participants in the efficacy sample who met the revised randomization criteria for incomplete response as defined in protocol amendment 3. The LOCF data set included data recorded at a Phase B visit, if no observation was recorded, data was carried forward from the previous visit.||Units on a scale||Standard Deviation|Mean
698089|NCT01360645|Secondary|Mean Clinical Global Impression-Improvement (CGI-I) Scale Score (End of Phase A [Week 8]) to Week 14 by Trial Week for the Efficacy Sample.|The items on CGI-I scale are: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse. The score of 0 (= not assessed) will be set to missing. The CGI-I is therefore a 7-point scale from 1 through 7. The CGI-I was measured in related to Baseline (Week 8).|Week 9, 10, 11, 12, 13, and 14|The Efficacy Sample comprised of all participants in the Safety Sample who had an end of Phase A (i.e, Week 8) value and at least one post-randomization efficacy evaluation for MADRS total score in Phase B. The LOCF data set included data recorded at a Phase B visit, if no observation was recorded, data was carried forward from the previous visit.||Units on a scale||Standard Deviation|Mean
698090|NCT01360645|Secondary|Change From Baseline (End of Phase A [Week 8]) to Week 14 in MADRS Total Score by Trial Week for the Efficacy Sample Per the Final Protocol.|"The MADRS consists of 10 items, all rated on a 0 to 6 scale with 0 being the best rating and 6 being the worst rating. The MADRS total score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60. The MADRS total score will be un-evaluable if less than 8 of the 10 items are recorded. If 8 or 9 of the 10 items are recorded, the MADRS total score will be the mean of the recorded items multiplied by 10 and then rounded to the first decimal place."|Week 9, 10, 11, 12, and 13|All participants in the efficacy sample who met the revised randomization criteria for incomplete response as defined in protocol amendment 3.||Units on a scale||Standard Error|Least Squares Mean
698091|NCT01360645|Secondary|Change From Baseline (End of Phase A [Week 8]) to Week 14 in MADRS Total Score by Trial Week for the Efficacy Sample.|"The MADRS consists of 10 items, all rated on a 0 to 6 scale with 0 being the best rating and 6 being the worst rating. The MADRS total score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60. The MADRS total score will be un-evaluable if less than 8 of the 10 items are recorded. If 8 or 9 of the 10 items are recorded, the MADRS total score will be the mean of the recorded items multiplied by 10 and then rounded to the first decimal place."|Week 9, 10, 11, 12, and 13|The Efficacy Sample comprised of all participants in the Safety Sample who had an end of Phase A (i.e, Week 8) value and at least one post-randomization efficacy evaluation for MADRS total score in Phase B.||Units on a scale||Standard Error|Least Squares Mean
698092|NCT01360645|Secondary|Mean Change From Baseline (End of Phase A [Week 8]) to Week 14 in SDS Score for the Efficacy Sample Per the Final Protocol|The SDS is a self-rated instrument used to measure the effect of the patient’s symptoms on work/school, social life, and family/home responsibilities. For each of the three items, scores range from 0 through 10. The number most representative of how much each area was disrupted by symptoms is marked along the line from 0 = not at all, to 10 = extremely. For the work/school item, no response was to be entered if the patient did not work or go to school for reasons unrelated to the disorder and a response therefore not being applicable. The Mean SDS Score will be calculated over the three item scores. All three item scores need to be available with the exception of the work/school item score when this item is not applicable.|Baseline and Week 14|All participants in the efficacy sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||Units on a scale||Standard Error|Least Squares Mean
698093|NCT01360645|Secondary|Mean Change From Baseline (End of Phase A [Week 8]) to Week 14 in Sheehan Disability Scale (SDS) Score for the Efficacy Sample.|The SDS is a self-rated instrument used to measure the effect of the patient’s symptoms on work/school, social life, and family/home responsibilities. For each of the three items, scores range from 0 through 10. The number most representative of how much each area was disrupted by symptoms is marked along the line from 0 = not at all, to 10 = extremely. For the work/school item, no response was to be entered if the patient did not work or go to school for reasons unrelated to the disorder and a response therefore not being applicable. The Mean SDS Score will be calculated over the three item scores. All three item scores need to be available with the exception of the work/school item score when this item is not applicable.|Baseline and Week 14|The Efficacy Sample comprised of all participants in the Safety Sample who had an end of Phase A (i.e, Week 8) value and at least one post-randomization efficacy evaluation for MADRS total score in Phase B.||Units on a scale||Standard Error|Least Squares Mean
698094|NCT01360645|Primary|Change From Baseline (End of Phase A [Week 8]) to Week 14 in MADRS Total Score for the Efficacy Sample Per the Final Protocol.|"The MADRS consists of 10 items, all rated on a 0 to 6 scale with 0 being the best rating and 6 being the worst rating. The MADRS total score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60. The MADRS total score will be un-evaluable if less than 8 of the 10 items are recorded. If 8 or 9 of the 10 items are recorded, the MADRS total score will be the mean of the recorded items multiplied by 10 and then rounded to the first decimal place."|Baseline and Week 14|All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||Units on a scale||Standard Error|Least Squares Mean
699225|NCT00001656|Other Pre-specified|Change in Body Mass Index (BMI)|BMI is calculated by the following formula: weight (in kilograms) divided by the square of the height (in meters)|8 week double-blind study period; baseline and 8 weeks|||kg/m²||Standard Deviation|Mean
698095|NCT01360645|Primary|Change From Baseline (End of Phase A [Week 8]) to Week 14 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score for the Efficacy Sample.|"The MADRS consists of 10 items, all rated on a 0 to 6 scale with 0 being the best rating and 6 being the worst rating. The MADRS total score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60. The MADRS total score will be un-evaluable if less than 8 of the 10 items are recorded. If 8 or 9 of the 10 items are recorded, the MADRS total score will be the mean of the recorded items multiplied by 10 and then rounded to the first decimal place."|Baseline and Week 14|The Efficacy Sample comprised of all participants in the Safety Sample who had an end of Phase A (i.e, Week 8) value and at least one post-randomization efficacy evaluation for MADRS total score in Phase B.||Units on a scale||Standard Error|Least Squares Mean
698096|NCT01360632|Secondary|Percentage of Participants With a CGI-I Response During Phase B Relative to the End of Phase A (Week 8 Visit) for the Efficacy Sample Per Final Protocol|A CGI-I response was defined as a CGI-I score of 1 (very much improved) or 2 (much improved).|Weeks, 8, 9, 10, 11, 12, 13, and 14|All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||Percentage of participants|||Number
698097|NCT01360632|Secondary|Percentage of Participants With a CGI-I Response During Phase B Relative to the End of Phase A (Week 8 Visit) for the Efficacy Sample Set|A CGI-I response was defined as a CGI-I score of 1 (very much improved) or 2 (much improved).|Weeks 8, 9, 10, 11, 12, 13 and 14|The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||Percentage of participants|||Number
698098|NCT01360632|Secondary|Percentage of Participants With a MADRS Remission During Phase B Relative to the End of Phase A (Week 8) for the Efficacy Sample Per Final Protocol|MADRS remission was defined as a < or equal to 10 and > or equal to 50% reduction in MADRS Total Score from end of Phase A (Week 8). The MADRS was utilized as an efficacy assessment of a participant's level of depression. The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the “best” rating and 6 being the “worst” rating. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place. The MADRS Total Score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60, with higher values indicating worse outcome.|Weeks 8, 9, 10, 11, 12, 13 and 14|All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||Percentage of participants|||Number
698099|NCT01360632|Secondary|Percentage of Participants With a MADRS Remission During Phase B Relative to the End of Phase A (Week 8) for the Efficacy Sample Set|MADRS remission was defined as a < or equal to 10 and > or equal to 50% reduction in MADRS Total Score from end of Phase A (Week 8). The MADRS was utilized as an efficacy assessment of a participant's level of depression. The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the “best” rating and 6 being the “worst” rating. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place. The MADRS Total Score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60, with higher values indicating worse outcome.|Weeks 8, 9, 10, 11, 12, 13 and 14|The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||Percentage of participants|||Number
698100|NCT01360632|Secondary|Percentage of Participants With a MADRS Response During Phase B Relative to the End of Phase A (Week 8 Visit) for the Efficacy Sample Per Final Protocol|MADRS response was defined as >=50 percent reduction in MADRS Total Score from end of Phase A (Week 8). The MADRS was utilized as an efficacy assessment of a participant's level of depression. The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the “best” rating and 6 being the “worst” rating. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place. The MADRS Total Score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60, with higher values indicating worse outcome.|Weeks 8, 9, 10, 11, 12, 13, and 14|All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||Percentage of participants|||Number
698101|NCT01360632|Secondary|Percentage of Participants With a MADRS Response During Phase B Relative to the End of Phase A (Week 8 Visit) for the Efficacy Sample Set|MADRS response was defined as >=50 percent reduction in MADRS Total Score from end of Phase A (Week 8). The MADRS was utilized as an efficacy assessment of a participant's level of depression. The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the “best” rating and 6 being the “worst” rating. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place. The MADRS Total Score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60, with higher values indicating worse outcome.|Weeks 8, 9, 10, 11, 12, 13, and 14|The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||Percentage of participants|||Number
698102|NCT01360632|Secondary|Mean CGI-I Score at Each Trial Week Visit in Phase B for the Efficacy Sample Per Final Protocol|The efficacy of study medication was rated for each participant using the CGI-I. The study physician would rate the participant's total improvement whether or not it is due entirely to drug treatment. Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.|Weeks 8, 9, 10, 11, 12, 13, and 14|All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||Units on a scale||Standard Deviation|Mean
699126|NCT01348139|Secondary|AUC: Area Under the Plasma Concentration-time Curve From Zero to Infinity (AUC),|Area under the plasma concentration-time curve from zero to infinity (AUC), for AZD3199 doses|0 - 120 hrs for first two treatment visit 2 and 3 and 0 - 48 hrs for other treatment visits.|PK analysis set||nmol*h/L||Standard Deviation|Mean
698103|NCT01360632|Secondary|Mean CGI-I Score at Each Trial Week Visit in Phase B for the Efficacy Sample Set|"The efficacy of study medication was rated for each participant using the CGI-I. The study physician would rate the participant's total improvement whether or not it is due entirely to drug treatment.
Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse."|Week 8 to Week 14|The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||Units on a scale||Standard Deviation|Mean
698104|NCT01360632|Secondary|Mean Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in HAM-A Total for the Efficacy Sample Per Final Protocol|The HAM-A is utilized for the evaluation of anxiety symptoms. The HAM-A consists of 14 items. Each item is rated on a 0 to 4 scale. For all of these items, 0 is the “best” rating and 4 is the “worst” rating. If no item scores are missing, then the HAM-A total score is the sum of all 14 item scores. The possible total scores are from 0 to 56, with higher score indicating worse anxiety symptoms.|Baseline and Week 14|All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||Units on a scale||Standard Error|Least Squares Mean
698105|NCT01360632|Secondary|Mean Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Hamilton Anxiety Rating Scale (HAM-A) Total Score for the Efficacy Sample Set|The HAM-A is utilized for the evaluation of anxiety symptoms. The HAM-A consists of 14 items. Each item is rated on a 0 to 4 scale. For all of these items, 0 is the “best” rating and 4 is the “worst” rating. If no item scores are missing, then the HAM-A total score is the sum of all 14 item scores. The possible total scores are from 0 to 56, with higher scores indicating worse anxiety symptoms.|Baseline and Week 14|The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||Units on a scale||Standard Error|Least Squares Mean
698106|NCT01360632|Secondary|Mean Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in HAM-D17 Total Score for the Efficacy Sample Set Per Final Protocol|The HAM-D17 was utilized as a secondary assessment of a participants level of depression. The HAM-D (17-Item) consisted of 17 items. Eight items were rated on a 0 to 2 scale (items 4, 5, 6, 12, 13, 14, 16 and 17), while nine items (items 1, 2, 3, 7, 8, 9, 10, 11, and 15) were rated on a 0 to 4 scale (twice the weight of the other items). For all of these items, 0 was the “best” rating and the highest score (2 or 4) was the “worst” rating. The possible total scores were from 0 to 52, with higher score indicating more severe depression.|Baseline and Week 14|All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||Units on a scale||Standard Error|Least Squares Mean
698107|NCT01360632|Secondary|Mean Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) Hamilton Depression Scale 17 Item Version (HAM)-D17 Total Score for the Efficacy Sample Set|The HAM-D17 was utilized as a secondary assessment of a participants level of depression. The HAM-D (17-Item) consisted of 17 items. Eight items were rated on a 0 to 2 scale (items 4, 5, 6, 12, 13, 14, 16 and 17), while nine items (items 1, 2, 3, 7, 8, 9, 10, 11, and 15) were rated on a 0 to 4 scale (twice the weight of the other items). For all of these items, 0 was the “best” rating and the highest score (2 or 4) was the “worst” rating. The possible total scores were from 0 to 52, with higher scores indicating more severe depression.|Baseline and Week 14|The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||Units on a scale||Standard Error|Least Squares Mean
698108|NCT01360632|Secondary|Mean Change From End of Phase A (Week 8 Visit) for Every Study Week Visit in Phase B in IDS-SR Total Score for the Efficacy Sample Per Final Protocol|The IDS-SR was a 30-item self-report measured to assess core diagnostic depressive symptoms as well as atypical and melancholic symptom features of major depressive disorders. The IDS-SR consists of 30 items, all rated on a 0 to 3 scale with 0 being the “best” rating and 3 being the “worst” rating. Besides item 9, two sub-items 9A and 9B exist, with possible scores of 1, 2 or 3 for item 9A, and 0 or 1 for item 9B. The scores for these two sub-items were not included in the calculation of the total score. The IDSSR Total Score was the sum of ratings of 28 item scores. The possible IDSSR Total Score ranged from 0 to 84. The IDS-SR Total Score was un-evaluable if less than 23 of the 28 items were recorded. If the number of items recorded was at least 23 and at most 27, the IDS-SR Total Score was the mean of the recorded items multiplied by 28, and was then rounded off to the first decimal place.|Weeks 8, 9, 10, 11, 12, 13, and 14|All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||Units on a scale||Standard Error|Least Squares Mean
698109|NCT01360632|Secondary|Mean Change From End of Phase A (Week 8 Visit) for Every Study Week Visit in Phase B in Inventory of Depressive Symptomatology (Self-Report) IDS-SR Total Score for the Efficacy Sample Set|IDS-SR was a 30-item self-report measured to assess core diagnostic depressive symptoms and atypical and melancholic symptom features of major depressive disorders. The IDS-SR consists of 30 items, all rated on a 0 to 3 scale with 0 being the “best” rating and 3 being the “worst” rating. Besides item 9, two sub-items 9A and 9B exist, with possible scores of 1, 2 or 3 for item 9A, and 0 or 1 for item 9B. The scores for these two sub-items were not included in the calculation of the total score. The IDS-SR Total Score was the sum of ratings of 28 item scores. The possible IDSSR Total Score ranged from 0 to 84. The IDS-SR Total Score was un-evaluable if less than 23 of the 28 items were recorded. If the number of items recorded was at least 23 and at most 27, the IDS-SR Total Score was the mean of the recorded items multiplied by 28, and was then rounded off to the first decimal place.|Weeks 8, 9, 10, 11, 12, 13, and 14|The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||Units on a scale||Standard Error|Least Squares Mean
698217|NCT01358864|Primary|Sustained Virological Response 12 Weeks Post Treatment (SVR12)|Percentage of participants with sustained virological response (SVR12) 12 weeks post treatment defined as plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level <25 IU/mL (undetected) 12 weeks after the originally planned treatment duration.|12 weeks post treatment, up to 60 weeks|FAS||percentage of participants||95% Confidence Interval|Number
698110|NCT01360632|Secondary|Mean Change From End of Phase A (Week 8 Visit) to Phase B by Study Week in Clinical CGI-S for the Efficacy Sample Per Final Protocol|The severity of illness for each participant was rated using the CGI-S. To perform this assessment, the study physician had to answer the following question: “Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?” Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.|Weeks 8, 9, 10, 11, 12, 13, and 14|All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||Units on a scale||Standard Error|Least Squares Mean
698111|NCT01360632|Secondary|Mean Change From End of Phase A (Week 8 Visit) to Phase B by Study Week in Clinical Global Impression Severity of Illness (CGI-S) for the Efficacy Sample Set|The severity of illness for each participant was rated using the CGI-S. To perform this assessment, the study physician had to answer the following question: “Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?” Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.|Weeks 8, 9, 10, 11, 12,13 and 14|The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||Units on a scale||Standard Error|Least Squares Mean
698112|NCT01360632|Secondary|Change From Baseline (End of Phase A [Week 8]) in SDS Item Scores for the Efficacy Sample Set Per Final Protocol|The SDS is a self-rated instrument used to measure the effect of the patient’s symptoms on work/school, social life, and family/home responsibilities. For each of the three items, scores range from 0 through 10. The number most representative of how much each area was disrupted by symptoms is marked along the line from 0 = not at all, to 10 = extremely. For the work/school item, no response was to be entered if the patient did not work or go to school for reasons unrelated to the disorder and a response therefore not being applicable. The Mean SDS Score will be calculated over the three item scores. All three item scores need to be available with the exception of the work/school item score when this item is not applicable.|Week 11 and Week 14|All participants in the efficacy sample who met the revised randomization criteria for incomplete response as defined in protocol amendment 3.||Units on a scale||Standard Error|Least Squares Mean
698113|NCT01360632|Secondary|Change From Baseline (End of Phase A [Week 8]) in SDS Item Scores for the Efficacy Sample Set|The SDS is a self-rated instrument used to measure the effect of the patient’s symptoms on work/school, social life, and family/home responsibilities. For each of the three items, scores range from 0 through 10. The number most representative of how much each area was disrupted by symptoms is marked along the line from 0 = not at all, to 10 = extremely. For the work/school item, no response was to be entered if the patient did not work or go to school for reasons unrelated to the disorder and a response therefore not being applicable. The Mean SDS Score will be calculated over the three item scores. All three item scores need to be available with the exception of the work/school item score when this item is not applicable.|Week 11 and Week 14|The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||Units on a scale||Standard Error|Least Squares Mean
698114|NCT01360632|Secondary|Mean Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in SDS Mean Scores for the Efficacy Sample Per Final Protocol|The SDS was a self-rated instrument used to measure the effect of the participants symptoms on work/school, social life, and family/home responsibilities. For each of the three items, scores ranged from 0 through 10. The number most representative of how much each area was disrupted by symptoms was marked along the line from 0= not at all, to 10= extremely. For the work/school item, no response was to be entered if the participant did not work or go to school for reasons unrelated to the disorder and a response therefore not being applicable. The Mean SDS score were calculated over the three item scores. All three item scores were needed to be available with the exception of the work/school item score when this item was not applicable.|Week 11 and Week 14|All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||Units on a scale||Standard Error|Least Squares Mean
698115|NCT01360632|Secondary|Mean Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Sheehan Disability Scale (SDS) Mean Scores for the Efficacy Sample Set|The SDS was a self-rated instrument used to measure the effect of the participants symptoms on work/school, social life, and family/home responsibilities. For each of the three items, scores ranged from 0 through 10. The number most representative of how much each area was disrupted by symptoms was marked along the line from 0= not at all to 10= extremely. For the work/school item, no response was to be entered if the participant did not work or go to school for reasons unrelated to the disorder and a response therefore not being applicable. The Mean SDS score were calculated over the three item scores. All three item scores were needed to be available with the exception of the work/school item score when this item was not applicable.|Week 11 and Week 14|The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||Units on a scale||Standard Error|Least Squares Mean
698116|NCT01360632|Secondary|Mean Change From End of Phase A (Week 8 Visit) in MADRS Total Score for Every Study Week Visit in Phase B Other Than Week 14 Visit for the Efficacy Sample Per Final Protocol|The MADRS was utilized as the primary efficacy assessment of a participant's level of depression. The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the “best” rating and 6 being the “worst” rating. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place. The MADRS Total Score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60, with higher values indicating worse outcome.|Week 8, 9, 10, 11, 12, and 13|All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||Units on a scale||Standard Error|Least Squares Mean
699226|NCT00001656|Other Pre-specified|Change in Weight||8 week double-blind study period; baseline and 8 weeks|||kilograms||Standard Deviation|Mean
698117|NCT01360632|Secondary|Mean Change From End of Phase A (Week 8 Visit) in MADRS Total Score for Every Study Week Visit in Phase B Other Than Week 14 Visit for the Efficacy Sample Set|The MADRS was utilized as the primary efficacy assessment of a participant's level of depression. The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the “best” rating and 6 being the “worst” rating. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place. The MADRS Total Score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60, with higher values indicating worse outcome.|Week 8, 9, 10, 11, 12, and 13|The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||Units on a scale||Standard Error|Least Squares Mean
698118|NCT01360632|Primary|Mean Change in MADRS Total Score From Baseline End of Week 8 to Week 14 for the Efficacy Sample Per Final Protocol|The MADRS was utilized as the primary efficacy assessment of a participant's level of depression. The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the “best” rating and 6 being the “worst” rating. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place. The MADRS Total Score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60, with higher values indicating worse outcome.|Baseline and Week 14|Analysis was based on all participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||Units on a scale||Standard Error|Least Squares Mean
698119|NCT01360632|Primary|Mean Change From the End of Phase A (Week 8 Visit) to Phase B (Week 14 Visit) in the Montgomery-Asberg Depression Rating Scale for the Efficacy Sample Set|The MADRS was utilized as the primary efficacy assessment of a participant's level of depression. The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the “best” rating and 6 being the “worst” rating. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place. The MADRS Total Score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60, with higher values indicating worse outcome.|Baseline and Week 14|The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||Units on a scale||Standard Error|Least Squares Mean
698120|NCT01360554|Secondary|Mean and Difference in Mean of the EuroQoL-5 Dimensions (EQ-5D) Visual Analogue Scale (VAS) Score|The EQ-5D is a validated and reliable self-report preference-based measure developed by the EuroQoL Group to assess health-related quality of life. It consists of the EQ-5D descriptive system and a visual analogue scale-the EQ VAS. The EQ-5D descriptive system measures a participants' health state on 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels, reflecting “no health problems,” “moderate health problems,” and “extreme health problems.” The EQ VAS records the respondent’s self-rated health on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state).|Data taken from Cycle 1 day 1 to the end of treatment or withdrawal, averaged (mean) to provide overall scores.|The PRO analysis set included all participants who started treatment and completed the baseline and at least 1 post-dosing PRO assessment.||Units on a scale.||95% Confidence Interval|Mean
698121|NCT01360554|Secondary|Mean and Difference in Mean in Lung Cancer Symptom Scores as Assessed by the EORTC QLQ- LC13.|The QLQ-LC13 included questions specific to the disease associated symptoms (dyspnea, cough, haemoptysis, and site specific pain), treatment-related symptoms (sore mouth, dysphagia, neuropathy, and alopecia), and analgesic use of lung cancer patients. Scores range from 0-100 and a higher score indicates greater degree of symptoms/problems. Overall scores present the mean score for that scale from all time-point data.|Data taken from Cycle 1 day 1 to the end of treatment or withdrawal, averaged (mean) to provide overall scores.|The PRO analysis set included all participants who started treatment and completed the baseline and at least 1 post-dosing PRO assessment.||Units on a scale.||95% Confidence Interval|Mean
698122|NCT01360554|Secondary|Mean and Difference in Mean in QLQ-C30 Symptoms as Assessed by the EORTC-QLQ-C30.|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Scores ranged from 0-100 where a higher score indicated a greater degree of symptoms/problems. Overall scores present the mean score for that scale from all time-point data.|Data taken from Cycle 1 day 1 to the end of treatment or withdrawal, averaged (mean) to provide overall scores.|The PRO analysis set included all participants who started treatment and completed the baseline and at least 1 post-dosing PRO assessment.||Units on a scale.||95% Confidence Interval|Mean
698123|NCT01360554|Secondary|Mean and Difference in Mean in Functioning and Global Quality of Life (QOL) as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Scores ranged from 0-100 where a higher score indicated a better level of quality of life. Overall scores present the mean score for that scale from all time-point data.|Data taken from Cycle 1 day 1 to the end of treatment or withdrawal, averaged (mean) to provide overall scores.|The PRO analysis set included all participants who started treatment and completed the baseline and at least 1 post-dosing PRO assessment.||Units on a scale.||95% Confidence Interval|Mean
698140|NCT01360021|Secondary|Use of Rescue Medication Day and Night (Total Daily Rescue Medication Use)|Total daily rescue medication use is calculated as the sum of morning and evening use each day and averaged over the 12 weeks treatment periods to calculate the treatment period mean. Baseline= Mean rescue medication used during run-in period ; Trt Avg=Mean rescue medication used during double-blind period.|Recorded between 6:00 – 11:00 AM from previous 12 hours and 6:00 -11:00 PM from previous 12 hours for 14 weeks|Full analysis set: It consist of all randomized patients who received at least one dose of study medication and contributed sufficient data for at least one efficacy endpoint (Primary variable).||Inhalations/24 hrs||Standard Deviation|Mean
698124|NCT01360554|Secondary|Time to Deterioration (TTD) in Pain, Dyspnea, Fatigue or Cough Patient Reported Disease Symptoms.|TTD defined as the time from first dose (baseline) to the first time a patient's score in pain, dyspnea, fatigue or cough from the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (QLQ-LC13) increased by ≥10 points. A ≥10 point increase in score had to be maintained for ≥2 consecutive cycles for the symptom to be considered deteriorated. Participants were censored at the last time when they completed an assessment for pain, dyspnea, fatigue or cough if they had not deteriorated. A 10 point or higher change in the score is perceived by participants as clinically significant.|Data taken from Cycle 1 day 1 to the end of treatment or withdrawal.|The PRO analysis set included all participants who started treatment and completed the baseline and at least 1 post-dosing PRO assessment.||Months||95% Confidence Interval|Median
698125|NCT01360554|Secondary|Trough Concentrations (Ctrough) of PF-05199265.|Mean Ctrough values of PF-05199265 observed from Cycle 2 through 5, Day 1 for dose compliant participants.|Baseline up to Cycle 5 Day 1|Participants treated with dacomitinib with at least one measured plasma concentration.||Trough Plasma Concentration (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
698126|NCT01360554|Secondary|Trough Concentrations (Ctrough) of Dacomitinib.|Mean Ctrough values of dacomitinib observed from Cycle 2 through 5, Day 1 for dose compliant participants.|Baseline up to Cycle 5 Day 1|Participants treated with dacomitinib with at least one measured plasma concentration.||Trough Plasma Concentration (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
698127|NCT01360554|Secondary|DR Based on Investigator Review.|DR was defined as the time from first documentation of response assessed by investigator review (CR or PR whichever occurred first) to date of progression or death due to any cause, whichever occurs first. Per RECIST version 1.1: CR: disappearance of all pre-existing lesions except nodal disease, with all nodal lesions decreased to normal size (short axis<10 mm) and no appearance of new unequivocal malignant lesions; PR: >=30% decrease from baseline sum of diameters of all target lesions with no unequivocal progression of pre-existing non-target lesions or appearance of new unequivocal malignant lesions; PD: >=20% increase in the sum of diameters of target lesions above the smallest sum observed, with a minimum absolute increase of 5 mm, or unequivocal progression of pre-existing non-target lesions or appearance of any new unequivocal malignant lesions.|From date of randomization until progression or death due to any cause. Participants were followed up until progressive disease regardless of start of subsequent cancer therapy.|DR was analyzed for a subgroup of participants in the ITT population, who had an objective tumor response.||Months||95% Confidence Interval|Median
698128|NCT01360554|Secondary|Duration of Response (DR) Based on Independent Radiologic Review.|DR was defined as the time from first documentation of response assessed by independent review (CR or PR whichever occurred first) to date of progression or death due to any cause, whichever occurs first. Per RECIST version 1.1: CR: disappearance of all pre-existing lesions except nodal disease, with all nodal lesions decreased to normal size (short axis<10 mm) and no appearance of new unequivocal malignant lesions; PR: >=30% decrease from baseline sum of diameters of all target lesions with no unequivocal progression of pre-existing non-target lesions or appearance of new unequivocal malignant lesions; PD: >=20% increase in the sum of diameters of target lesions above the smallest sum observed, with a minimum absolute increase of 5 mm, or unequivocal progression of pre-existing non-target lesions or appearance of any new unequivocal malignant lesions.|From date of randomization until progression or death due to any cause. Participants were followed up until progressive disease regardless of start of subsequent cancer therapy.|DR was analyzed for a subgroup of participants in the ITT population, who had an objective tumor response.||Months||95% Confidence Interval|Median
698129|NCT01360554|Secondary|BOR Per Investigator Review.|The BOR was the best response per RECIST (version 1.1) criteria as assessed by investigator assessment recorded from randomization until disease progression. Per RECIST version 1.1: CR: disappearance of all pre-existing lesions except nodal disease, with all nodal lesions decreased to normal size (short axis<10 mm) and no appearance of new unequivocal malignant lesions; PR: >=30% decrease from baseline sum of diameters of all target lesions with no unequivocal progression of pre-existing non-target lesions or appearance of new unequivocal malignant lesions; PD: >=20% increase in the sum of diameters of target lesions above the smallest sum observed, with a minimum absolute increase of 5 mm, or unequivocal progression of pre-existing non-target lesions or appearance of any new unequivocal malignant lesions.|From date of randomization until progression or initiation of new anti-cancer therapy or death. Participants were followed up until progressive disease regardless of start of subsequent cancer therapy.|The ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether patients received study drug or received a different drug from that to which they were randomized.||Participants|||Number
698130|NCT01360554|Secondary|Best Overall Response (BOR) Per Independent Radiologic Review.|The BOR was the best response per RECIST (version 1.1) criteria as assessed by independent assessment recorded from randomization until disease progression. Per RECIST version 1.1: Complete Response (CR): disappearance of all pre-existing lesions except nodal disease, with all nodal lesions decreased to normal size (short axis<10 mm) and no appearance of new unequivocal malignant lesions; Partial Response (PR): >=30% decrease from baseline sum of diameters of all target lesions with no unequivocal progression of pre-existing non-target lesions or appearance of new unequivocal malignant lesions; Progressive Disease (PD): >=20% increase in the sum of diameters of target lesions above the smallest sum observed, with a minimum absolute increase of 5 mm, or unequivocal progression of pre-existing non-target lesions or appearance of any new unequivocal malignant lesions.|From date of randomization until progression or initiation of new anti-cancer therapy or death. Participants were followed up until progressive disease regardless of start of subsequent cancer therapy.|The ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether patients received study drug or received a different drug from that to which they were randomized.||Participants|||Number
698141|NCT01360021|Secondary|Night-time Awakenings Due to Asthma Symptoms(% Awakening-free Nights)|The percentage of days with no awakenings due to asthma. Baseline= Mean % awakening-free nights during run-in period ; Trt Avg=Mean % awakening-free nights during double-blind period.|Recorded 6:00 – 11:00 AM for 14 weeks|Full analysis set: It consist of all randomized patients who received at least one dose of study medication and contributed sufficient data for at least one efficacy endpoint (Primary variable).||Percentage of days with no awakenings||Standard Deviation|Mean
698131|NCT01360554|Secondary|OS in KRAS-WT Participants.|OS was defined as the time from randomization to the date of death for any cause. In the absence of confirmation of death, survival time was censored at the last date the patient was known to be alive (ie, at their last known alive date from long term follow-up). Tumor tissue from participants' original diagnostic biopsies or recently obtained biopsies were analyzed to determine KRAS status.|From date of randomization until the date of death from any cause or last date known to be alive, participants were followed up regardless of the reason for discontinuation from study treatment at intervals of no longer than every 2 months.|ITT population for KRAS-WT participants: all participants who were confirmed as having KRAS-WT tumors, randomized, with study drug assignment designated according to initial randomization, regardless of whether patients received study drug or received a different drug from that to which they were randomized.||Months||95% Confidence Interval|Median
698132|NCT01360554|Secondary|Overall Survival (OS).|OS was defined as the time from randomization to the date of death for any cause. In the absence of confirmation of death, survival time was censored at the last date the patient was known to be alive (ie, at their last known alive date from long term follow-up).|From date of randomization until the date of death from any cause or last date known to be alive, participants were followed up regardless of the reason for discontinuation from study treatment at intervals of no longer than every 2 months.|The ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether patients received study drug or received a different drug from that to which they were randomized.||Months||95% Confidence Interval|Median
698133|NCT01360554|Secondary|PFS Based on Investigator Review in KRAS-WT Participants.|PFS was defined as the time from randomization to the date of disease progression as by RECIST v1.1 per Investigator's Review or death due to any cause, whichever occurred first. Objective progression was defined as a 20% increase in the sum of the diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm or unequivocal progression of pre-existing non-target lesions, or the appearance of any new unequivocal malignant lesions. Tumor tissue from participants' original diagnostic biopsies or recently obtained biopsies were analyzed to determine KRAS status.|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, participants were followed up until progressive disease regardless of start of subsequent cancer therapy.|ITT population for KRAS-WT participants: all participants who were confirmed as having KRAS-WT tumors, randomized, with study drug assignment designated according to initial randomization, regardless of whether patients received study drug or received a different drug from that to which they were randomized.||Months||95% Confidence Interval|Median
698134|NCT01360554|Secondary|PFS Based on Investigator Review.|PFS was defined as the time from randomization to the date of disease progression as by RECIST v1.1 per Investigator's Review or death due to any cause, whichever occurred first. Objective progression was defined as a 20% increase in the sum of the diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm or unequivocal progression of pre-existing non-target lesions, or the appearance of any new unequivocal malignant lesions.|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, participants were followed up until progressive disease regardless of start of subsequent cancer therapy.|The ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether patients received study drug or received a different drug from that to which they were randomized.||Months||95% Confidence Interval|Median
698135|NCT01360554|Primary|Progression-Free Survival (PFS) Per Independent Radiologic Review in KRAS Wild-type (WT) Participants.|PFS was defined as the time from randomization to the date of disease progression as by RECIST v1.1 per Independent Radiologic Review or death due to any cause, whichever occurred first. Objective progression was defined as a 20% increase in the sum of the diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm or unequivocal progression of pre-existing non-target lesions, or the appearance of any new unequivocal malignant lesions. Tumor tissue from participants' original diagnostic biopsies or recently obtained biopsies were analyzed to determine KRAS status.|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, participants were followed up until progressive disease regardless of start of subsequent cancer therapy.|ITT population for KRAS-WT participants: all participants who were confirmed as having KRAS-WT tumors, randomized, with study drug assignment designated according to initial randomization, regardless of whether patients received study drug or received a different drug from that to which they were randomized.||Months||95% Confidence Interval|Median
698136|NCT01360554|Primary|Progression-Free Survival (PFS) Per Independent Radiologic Review.|PFS was defined as the time from randomization to the date of disease progression as by Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 per Independent Radiologic Review or death due to any cause, whichever occurred first. Objective progression was defined as a 20% increase in the sum of the diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm or unequivocal progression of pre-existing non-target lesions, or the appearance of any new unequivocal malignant lesions.|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, participants were followed up until progressive disease regardless of start of subsequent cancer therapy.|The ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether patients received study drug or received a different drug from that to which they were randomized.||Months||95% Confidence Interval|Median
698137|NCT01360450|Secondary|Cumulative Dose of Opioid and Benzodiazepine|We will determine the total amount of opioid and benzodiazepine needed from the start of detoxification to the end of the the detoxification.|2-4 weeks|No data is available for this outcome measure, as it was not collected.|||||
698138|NCT01360450|Secondary|Cardiovascular Side-effects Changes HR and BP|Changes in Heart Rate (HR) and BP for 48 hrs after starting study drug and for 48hrs after stopping study drug|48 hrs after starting study drug and for 48hrs after stopping study drug|No data is available for this outcome measure, as it was not collected.|||||
698142|NCT01360021|Secondary|Asthma Symptoms Score (Total)|The total score is calculated as sum of the morning and evening scores of each day and the treatment period mean score is defined as the mean of all total score recorded during the 12-week treatment period. Trt Avg=Mean total score of double-blind period values.(day/night score ranges from 0 to 3; 0=no asthma symptoms; 3= unable to do normal activities (or to sleep) due to asthma). Higher score represents worse outcome.|Recorded between 6:00 – 11:00 AM from previous 12 hours and 6:00 -11:00 PM from previous 12 hours for 14 weeks|Full analysis set: It consist of all randomized patients who received at least one dose of study medication and contributed sufficient data for at least one efficacy endpoint (Primary variable).||Asthma score on a scale of 0 to 3||Standard Deviation|Mean
698143|NCT01360021|Secondary|Peak Expiratory Flow||Recorded morning upon rising and evening before sleep for 14 weeks|Full analysis set: It consist of all randomized patients who received at least one dose of study medication and contributed sufficient data for at least one efficacy endpoint (Primary variable).||L/Min||Standard Deviation|Mean
698144|NCT01360021|Primary|Forced Expiratory Volume in 1 Second (FEV1) - Pre Dose|Descriptive statistics for predose FEV1(L) by visit; Baseline defined as the last pre-dose value prior to 1st dose of randomized therapy. Trt Avg = Mean of all available valid values after randomization.|Pre AM dose in clinic visits at baseline, and week 3, 7, 12 and Trt Avg|Full analysis set: It consist of all randomized patients who received at least one dose of study medication and contributed sufficient data for at least one efficacy endpoint (Primary variable).||Liters||Geometric Coefficient of Variation|Geometric Mean
698145|NCT01360021|Primary|Forced Expiratory Volume in 1 Second (FEV1) - Post Dose|Descriptive statistics for post-dose FEV1 (L) by visit; Baseline defined as the last pre-dose value prior to 1st dose of randomized therapy. Trt Avg = Mean of all available valid values after randomization.|60 minutes post-dose in clinic visits at baseline, and week 0, 3, 7, 12 and Trt Avg|Full analysis set: It consist of all randomized patients who received at least one dose of study medication and contributed sufficient data for at least one efficacy endpoint (Primary variable).||Liter||Geometric Coefficient of Variation|Geometric Mean
698146|NCT01359943|Secondary|Change From Baseline in ESR|Blood for this assessment was obtained to monitor disease activity and response to therapy. A negative change from baseline indicates improvement.|baseline, 12 weeks|Full analysis set (FAS): The FAS included all participants who were randomized to study treatment.||mm/hr||Standard Error|Least Squares Mean
698147|NCT01359943|Secondary|Change From Baseline in hsCRP|Blood for this assessment was obtained to identify the presence of inflammation, to determine its severity, and to monitor response to treatment. A negative change from baseline indicates improvement.|baseline, 12 weeks|Full analysis set (FAS): The FAS included all participants who were randomized to study treatment.||mg/L||Standard Error|Least Squares Mean
698148|NCT01359943|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity|The physician’s global assessment of disease activity was performed using 100 mm VAS ranging from 0 (very good) to 100 (very poor), after the question “Considering all the ways rheumatoid arthritis affects your patient, how would you rate his or her current condition?”. A negative change from baseline indicates improvement.|baseline, 12 weeks|Full analysis set (FAS): The FAS included all participants who were randomized to study treatment.||score on a scale||Standard Error|Least Squares Mean
698149|NCT01359943|Secondary|Change From Baseline in Participant's Global Assessment of Disease Activity|"The patient’s global assessment of disease activity was performed using 100 mm VAS ranging from 0 (very good) to 100 (very poor), after the question Considering all the ways rheumatoid arthritis affects you, please indicate with a vertical mark through the horizontal line how well you are doing today”. A negative change from baseline indicates improvement."|baseline, 12 weeks|Full analysis set (FAS): The FAS included all participants who were randomized to study treatment.||score on a scale||Standard Error|Least Squares Mean
698150|NCT01359943|Secondary|Change From Baseline in Participant's Assessment of Rheumatoid Arthritis (RA) Pain|The patient’s assessment of pain was performed using 100 mm visual analog scale (VAS) ranging from 0 (no pain) to 100 (unbearable pain) after the question “Please indicate with a vertical mark through the horizontal line the most pain you had from your rheumatoid arthritis over the last 24 hours”. A negative change from baseline indicates improvement.|baseline, 12 weeks|Full analysis set (FAS): The FAS included all participants who were randomized to study treatment.||score on a scale||Standard Error|Least Squares Mean
698151|NCT01359943|Secondary|Change From Baseline in Tender 68-joint Count|The 68 joints assessed for tenderness included the 8 distal interphalangeal, 10 proximal interphalangeal and 10 metacarpophalangeal joints of the hands, the 10 metatarsophalangeal and 10 proximal interphalangeal joints of the feet, the 2 wrists, 2 elbows , 2 shoulders , 2 acromioclavicular, 2 sternoclavicular, 2 temporomandibular, 2 hip, 2 knee, 2 talo-tibial, and 2 mid-tarsal joints. Joint tenderness was graded present (1) or absent (0). A negative change from baseline indicates improvement.|baseline, 12 weeks|Full analysis set (FAS): The FAS included all participants who were randomized to study treatment.||Number of joints||Standard Error|Least Squares Mean
698152|NCT01359943|Secondary|Change From Baseline in Swollen 66-joint Count|The 66 joints assessed for swelling included the 8 distal interphalangeal, 10 proximal interphalangeal and 10 metacarpophalangeal joints of the hands, the 10 metatarsophalangeal and 10 proximal interphalangeal joints of the feet, the 2 wrists, 2 elbows , 2 shoulders , 2 acromioclavicular, 2 sternoclavicular, 2 temporomandibular, 2 knee, 2 talo-tibial, and 2 mid-tarsal joints. Swelling was graded present (1) or absent (0). A negative change in baseline indicates improvement.|baseline, 12 weeks|Full analysis set (FAS): The FAS included all participants who were randomized to study treatment.||Number of joints||Standard Error|Least Squares Mean
698153|NCT01359943|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Response|EULAR response criteria are based on DAS28 status in combination with DAS28 improvements. The EULAR response criteria are as follows: present DAS28 <3.2 with DAS28 improvement >1.2 corresponds to 'good response'; present DAS28 <3.2 with DAS28 improvement between 0.6 to 1.2, or present DAS28 between 3.2 to 5.1 with DAS28 improvement from 0.6 to >1.2, or present DAS28 >5.2 with DAS28 improvement >1.2 correspond to 'moderate response; present DAS28 <3.2 with DAS28 improvement <0.6, or present DAS28 between 3.2 to 5.1 with DAS28 improvement <0.6, or present DAS28 >5.1 with DAS28 improvement <0.6 to 1.2 correspond to 'no response'.|baseline, 12 weeks|Full analysis set (FAS): The FAS included all participants who were randomized to study treatment.||Percentage of participants|||Number
723586|NCT00324649|Secondary|Percentage of Participants With Virologic Failure|Virologic failure was defined as two consecutive HIV RNA values > 400 copies/mL.|48 weeks|Treated participants.||Percentage of participants|||Number
698154|NCT01359943|Secondary|Change From Baseline in Disease Activity Score 28 Response Using ESR (DAS28-ESR)|The Disease Activity Score (DAS) is a combined index to measure disease activity in RA participants. DAS28 is determined using the following variables: 28-joint counts (tender28 and swollen28), erythrocyte sedimentation rate (ESR), and the participant's general health (GH) or global disease activity measured on a Visual Analogue Scale (VAS) of 100 mm (0 = and 100 = ). Using the data from these variables, DAS28-ESR is calculated using the following formula: DAS28 = 0.56 * sqrt(tender28) + 0.28 * sqrt(swollen28) + 0.70 * ln(ESR) + 0.014 * GH. The calculation results in a DAS28-ESR score from 0 to 10 indicating the current activity of the rheumatoid arthritis of your patient. A DAS28 above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity. Remission is achieved by a DAS28 lower than 2.6. A negative change from baseline indicates improvement.|baseline, 12 weeks|Participants from the full analysis set (FAS), who had values at both baseline and week 12, were included in this analysis. The FAS included all participants who were randomized to study treatment.||score on a scale||Standard Error|Least Squares Mean
698155|NCT01359943|Secondary|Change From Baseline in DAS28 Using High Sensitivity C-reactive Protein (hsCRP) (DAS28-CRP)|The Disease Activity Score (DAS) is a combined index to measure disease activity in RA participants. DAS28-CRP is determined using the following variables: 28-joint counts (tender28 and swollen28), CRP, and the participant's general health (GH) or global disease activity measured on a Visual Analogue Scale (VAS) of 100 mm (0 = and 100 = ). Using the data from these variables, DAS28-CRP is calculated using the following formula: DAS28-4(crp) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014*GH + 0.96. The calculation results in a DAS28-CRP score from 0 to 10 indicating the current activity of the rheumatoid arthritis of your patient. A DAS28 above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity. Remission is achieved by a DAS28 lower than 2.6. A negative change from baseline indicates improvement.|baseline, 12 weeks|Participants from the full analysis set (FAS), who had values at both baseline and week 12, were included in this analysis. The FAS included all participants who were randomized to study treatment.||score on a scale||Standard Error|Least Squares Mean
698156|NCT01359943|Secondary|Change From Baseline in Health Assessment Questionnaire-Disease Index (HAQ-DI) Score.|The HAQ measures physical disability and functional status. It has 4 dimensions: disability, pain, drug side effects and dollar costs. In this trial, only the disability dimension was used. The disability dimension consists of 20 multiple choice items concerning difficulty in performing 8 common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Participants choose from four response categories: 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty) and 3 (unable to do). Within each of the 8 categories, only the item indicating the most severe impairment contributes to the category score. The HAQ score is calculated by summing the computed scores for each category and dividing by the number of categories answered. It ranges from 0 (without any difficulty) to 3 (unable to do). A negative change from baseline indicates improvement.|baseline, 12 Weeks|Full analysis set (FAS): The FAS included all participants who were randomized to study treatment.||score on a scale||Standard Error|Least Squares Mean
698157|NCT01359943|Secondary|Percentage of Participants Who Achieve ACR50 and ACR70|A participant was considered to be a responder according to the ACR50 or ACR70 criteria if the participant had at least 50% or 70% improvement, respectively, in both the tender joint count and swollen joint count measures, and in at least 3 of the following 5 measures: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score, and/or C-reactive protein (CRP)/Erythrocyte Sedimentation Rate (ESR).|12 weeks|Full analysis set (FAS): The FAS included all participants who were randomized to study treatment.||Percentage of participants|||Number
698158|NCT01359943|Primary|Percentage of Participants Who Achieve American College of Rheumatology Response of 20 (ACR20)|A participant was considered to be a responder according to the ACR20 criteria if the participant had at least 20% improvement in both the tender joint count and swollen joint count measures, and in at least 3 of the following 5 measures: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score, and/or C-reactive protein (CRP)/Erythrocyte Sedimentation Rate (ESR).|12 weeks|Full analysis set (FAS): The FAS included all participants who were randomized to study treatment.||Percentage of participants|||Number
698159|NCT01359904|Secondary|the Number of Infections Related to Vascular Access in Dialysis Among Those Who Receive a Higher Glucose Concentration in the Dialysate and Those Who Receive the Standard Concentration|In the two groups, we will measure the number of episodes of vascular access related infections ie. catheter, AV fistula or AV graft associated infections in the study period. The episode was defined as a diagnosis in the chart written by the nurse or physician with a prescription of antibiotics.|3 months|||episodes|||Number
698160|NCT01359904|Secondary|To Record the Effects of a Higher Dialysate Concentration of Glucose on Glycemic Control of Hemodialysis Patients With Type 2 Diabetes Mellitus by Measuring Serum Levels of Hemoglobin A1c.|Hemoglobin A1c levels will be measured before the intervention and after to assess any difference in the value. The blood samples were taken prior to dialysis treatments mid-week for each subject at baseline and at the end of the study in both the control and intervention groups.|3 months|||percent||Full Range|Median
698161|NCT01359904|Primary|Hemoglobin A1c Levels|post intervention hemoglobin A1c levels|3 months|We planned forty subjects to detect a difference in the mean change in the HbA1c from baseline to at the end of the study of 1% among the two dialysate concentration groups with a two-tailed t-test and variance of 1%, the required sample size will be 20 for each group with a power of 88% and alpha set at 0.05.||percent||Full Range|Median
698162|NCT01359904|Secondary|Episodes of Hypoglycemia|record number of episodes during dialysis with serum glucose below 4 mmol/L by glucometer|3 months|We planned forty subjects to detect a difference in the mean change in the HbA1c from baseline to at the end of the study of 1% among the two dialysate concentration groups with a two-tailed t-test and variance of 1%, the required sample size will be 20 for each group with a power of 88% and alpha set at 0.05.||episodes|||Number
698163|NCT01359748|Primary|BP Measurement Using Multifunction KEITO|"Prior starting the measurement phase using Multifunction KEITO, the under test device was reset before each new measurement.
The subject has to be at rest at least 60 seconds before be measured."|30 seconds|||mmHg||Standard Deviation|Mean
723587|NCT00324649|Secondary|Percentage of Participants With HIV-1 RNA > 50 and < 400 Copies/mL||48 weeks|Treated participants.||Percentage of participants|||Number
698165|NCT01359735|Secondary|Subject Reported Signs and Symptoms|Subjects reported signs or symptoms, based on the following 6 items, each scored as none (=0), mild (=1), moderate (=2), or severe (=3): irritation, itchiness, burning, tenderness, pain, and stinging. Item scores were averaged.|At each evaluation visit: Weeks 3, and 12 post-surgery.|The ITT population – all subjects who underwent MMS. Both the total score and individual item score of the two signs and symptoms rating scales were summarized descriptively at Weeks 4, 7, and 13 as well as at the treatment endpoint and compared using a two-sample t-test, and the P-value of a 1-sided test was reported.||units on a scale||Standard Deviation|Mean
698166|NCT01359735|Secondary|Investigator Reported Signs and Symptoms|Investigator reported signs and/or symptoms, based on the following 12 items, each scored as none (=0), mild (=1), moderate (=2), or severe (=3): Erythema, Erosion, Ulceration, Swelling, Scarring, Infection, Crusting, Necrosis, Peeling, Contact Dermatitis, Hyper/Hypopigmentation. Item scores were averaged.|At each evaluation visit: Weeks 3 and 12 post-surgery.|The ITT population–all subjects who underwent MMS. Both total score and individual item score of the two signs and symptoms rating scales summarized descriptively at Weeks 4, 7, and 13 as well as at the treatment endpoint and compared using a two-sample t-test. the P-value of a 1-sided test was reported.||units on a scale||Standard Deviation|Mean
698167|NCT01359735|Secondary|Time in Days to Wound Closure|The Kaplan-Meier survival analysis was used to calculate the mean time in days to complete wound closure.|Over the 12 week treatment period|The ITT population – all subjects who underwent MMS. The Log-rank test was used to test for an inter-group difference.||Days||Standard Deviation|Mean
698168|NCT01359735|Secondary|The Number of Subjects With Complete Wound Closure at Each Evaluation Visit.|Complete wound closure was assessed at each evaluation visit.|Over 12 weeks or until wound closure, which ever occurred first. Following completion of treatment subjects were followed for a further 4 weeks|The ITT population – all subjects who underwent MMS. Fisher’s exact test was used to examine the difference in proportion of subjects with complete wound closure at each of the corresponding time points between the two treatment groups, and the P-value of a 1-sided test was reported.||participants|||Number
698169|NCT01359735|Primary|The Primary Efficacy Measure Was the Investigator’s Global Assessment of Healing (IGAH).|The IGAH is a four-point scale based on the following assessment scores: 0 = not effective, 1 = slightly effective, 2 = moderately effective, 3 = very effective. The descriptive statistics for both a continuous variable and a categorical variable were summarized for IGAH by treatment week and treatment endpoint. The Wilcoxon rank-sum test was used to test the difference in IGAH score between HP802-247 and bacitracin ointment for each treatment week and treatment endpoint. Since this was a small and exploratory study, the P-value of a 1-sided test was reported.|13 weeks- The IGAH was measured at study Weeks 4 and 13|The ITT population – all subjects who underwent MMS.||units on a scale||Standard Deviation|Mean
698170|NCT01359644|Secondary|Number of Participants Who Died and With Serious Adverse Events (SAEs), Grade 3-4 Adverse Events (AEs), and Grade 3-4 Abnormalities on Laboratory Test Results During Follow-up Period|AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Based on the severity, AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Very severe|AEs: From Day 1 of follow-up period (Week 13 or 25) up to study discharge (up to 72 weeks). SAEs: From Day 1 of follow-up period (Week 13 or 25) up to 30 days after study discharge (up to 74 weeks)|All participants who received at least 1 dose of study drug and entered follow-up period||Participants|||Number
698171|NCT01359644|Secondary|Number of Participants Who Died and With Serious Adverse Events (SAEs) and Grade 3-4 Adverse Events (AEs), During the Treatment Period Prior to Addition of Rescue Therapy|AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Based on the severity, AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Very severe.|First dose of study drug (Day 1) up to the start of rescue therapy (12 or 24 weeks, depending on treatment group)|All participants who received at least 1 dose of study drug.||Participants|||Number
698172|NCT01359644|Secondary|Change From Baseline in log10 Hepatitis C Virus (HCV) RNA at Follow-up Week 24|Change from baseline in log10 HCV RNA at scheduled sampling time.|Baseline, Follow-up week 24|The analysis was performed in all treated participants who received at least 1 dose of active study therapy.||IU/mL||Standard Deviation|Mean
698173|NCT01359644|Secondary|Percentage of Participants Who Experienced Viral Relapse During Follow-up Period|Viral relapse during follow-up is defined as any confirmed quantifiable hepatitis C virus (HCV) RNA ≥25 IU/mL with HCV RNA levels less than the lower limit of quantitation, target detected or target not detected, ie, HCV RNA <25 IU/mL at the end of treatment.|Day 1 of follow-up period (Week 13 or 25, depending on treatment group) to end of follow-up period (up to 48 weeks)|The analysis was performed in all treated participants who received at least 1 dose of active study therapy. The ‘n’ signifies those participants evaluable for this measure at specified time points for each group, respectively.||Percentage of participants|||Number
698174|NCT01359644|Secondary|Percentage of Participants With Viral Breakthrough During the Treatment Period|Viral breakthrough is defined as any confirmed increase in viral load ≥1 log from nadir or any confirmed hepatitis C virus RNA levels ≥25 IU/mL on or after Week 8.|First dose of study drug (Day 1) up to end of treatment period (up to 12 or 24 weeks, depending on treatment group)|The analysis was performed in all treated participants who received at least 1 dose of active study therapy. The ‘n’ signifies those participants evaluable for this measure at specified time points for each group, respectively.||Percentage of participants|||Number
698175|NCT01359644|Secondary|Percentage of Participants With Sustained Virologic Response at Post Treatment Week 24 (SVR24)|SVR24 was defined as participant’s hepatitis C virus RNA less than the lower limit of quantitation, target detected or target not detected at follow-up Week 24. DCV=daclatasvir, SOF=sofosbuvir.|Follow-up Week 24|The analysis was performed in all treated participants who received at least 1 dose of active study therapy. Here the ‘n’ signifies those participants evaluable for this measure at specified time points for each group, respectively.||Percentage of participants|||Number
698177|NCT01359449|Secondary|Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Any of the Study Vaccination|Solicited Injection site: Tenderness, Erythema and Swelling: Solicited Systemic: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability|Day 0 up to Day 7 post-vaccination|Solicited injection site and systemic reactions were assessed in all enrolled and vaccinated participants in the Menactra vaccine group, intent to treat population||Participants|||Number
698178|NCT01359449|Secondary|Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With a Second Dose of Menactra Vaccine at 18 Months of Age|"Solicited Injection site: Tenderness, Erythema and Swelling: Solicited Systemic: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability.
Grade 3 reactions defined as: Tenderness - Cries when injected limb is moved, or the movement of the injected limb is reduced; Erythema and Swelling - ≥ 50 mm; Fever - > 39.5°C; Vomiting - ≥ 6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal - > 3 hours; Drowsiness - Sleeping most of the time or difficult to wake up; Appetite lost - Refuses ≥ 3 feeds/meals or refuses most feeds/meals, and Irritability - Inconsolable."|Day 0 up to Day 7 post-vaccination|Solicited injection site and systemic reactions were assessed in all enrolled and vaccinated participants in the Menactra vaccine group, intent to treat population||Participants|||Number
698179|NCT01359449|Secondary|Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate Vaccine at 12 Months of Age|"Solicited Injection site: Tenderness, Erythema and Swelling: Solicited Systemic: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability.
Grade 3 reactions defined as: Tenderness - Cries when injected limb is moved, or the movement of the injected limb is reduced; Erythema and Swelling - ≥ 50 mm; Fever - > 39.5°C; Vomiting - ≥ 6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal - > 3 hours; Drowsiness - Sleeping most of the time or difficult to wake up; Appetite lost - Refuses ≥ 3 feeds/meals or refuses most feeds/meals, and Irritability - Inconsolable."|Day 0 up to Day 7 post-vaccination|Solicited injection site and systemic reactions were assessed in all enrolled and vaccinated participants, intent-to-treat population||Participants|||Number
698180|NCT01359449|Secondary|Summary of Participants With Booster Response for Pediacel® Vaccine Antigens After Vaccination With Pediacel® Vaccine (Menactra Vaccine Group)|Pediacel vaccine administered only to the Menactra Vaccine Group. Booster response was defined as subjects with pre-dose titers < 4xLLOQ and have a 4-fold rise rate; or subjects with pre-dose titers ≥ 4xLLOQ and have a 2-fold rise rate|28 days post-vaccination|Pediacel® vaccine antigen booster responses were determined in the per-protocol population of the Menactra® vaccine group||Participants|||Number
698181|NCT01359449|Secondary|Geometric Mean Titers of Antibodies to Pediacel® Vaccine Antigens in Participants That Received a Dose of Menactra® at 12 and 18 Months of Age, Respectively, and a Booster Dose of Pediacel® Vaccine at 18 Months of Age.|Immunogenicity tests were performed at 18 and 19 months of age, respectively, before and after Pediacel® vaccination in the Menactra vaccine group|28 days post-vaccination|Geometric Mean Titers of of Pediacel vaccine antigens were determined in the per-protocol population of the Menactra® vaccine group.||Titers||95% Confidence Interval|Geometric Mean
698182|NCT01359449|Secondary|Number of Participants With Serum Bovine Albumin Human Complement Titers of ≥ 1:8 Following Vaccination With Either a Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age.|Immunogenicity tests were performed at 19 months of age in Menactra vaccine group after Menactra® vaccination and performed at 13 months and 19 months of age in the Menjugate vaccine group after Menjugate® vaccination|28 days post-vaccination|Immunogenicity using Serum Bovine Albumin Human Complement titers were determined in the per-protocol population||Participants|||Number
698183|NCT01359449|Secondary|Geometric Mean Titers of Serum Bovine Albumin Human Complement Titers Following Vaccination With Either One Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age.|Immunogenicity tests were performed at 19 months of age in Menactra Vaccine Group after Menactra® vaccination and performed at 13 months and 19 months of age in the Menjugate Vaccine Group after Menjugate® vaccination.|28 days post-vaccination|Geometric Mean Titers of Serum Bovine Albumin Human Complement titers were determined in the per-protocol population||Titers||95% Confidence Interval|Geometric Mean
698184|NCT01359449|Primary|Number of Participants With Serum Bovine Albumin Baby Rabbit Titers of ≥ 1:8 Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age.|Immunogenicity tests were performed at 19 months of age in Menactra Vaccine Group after Menactra® vaccination and performed at 13 months and 19 months of age in the Menjugate Vaccine Group after Menjugate® vaccination|28 days post-vaccination|Immunogenicity using Serum Bovine Albumin Baby Rabbit titers were determined in the per-protocol population||Participants|||Number
698185|NCT01359449|Primary|Geometric Mean Titers of Serum Bovine Albumin Baby Rabbit Titers Following Vaccination With Either One Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age.|Immunogenicity tests were performed at 19 months of age in Menactra Vaccine Group after Menactra® vaccination and performed at 13 months and 19 months of age in the Menjugate Vaccine Group after Menjugate® vaccination|28 days post-vaccination|Geometric Mean Titers of Serum Bovine Albumin Baby Rabbit titers were determined in the per protocol population||Titers||95% Confidence Interval|Geometric Mean
698186|NCT01359410|Post-Hoc|Intraoperative Complications Incurred by Participants||100 days or removal of drain|||intraoperative complications|||Number
698187|NCT01359410|Secondary|Number of Non-pancreatic Adverse Events||100 days or removal of drain|||non-pancreatic adverse events|||Number
698188|NCT01359410|Secondary|Time to Drain Removal||100 days or removal of drain|(1) participant in the mesh reinforcement arm was not evaluable due to death and (1) participant in the non-mesh reinforcement arm was not evaluable due to death.||days||95% Confidence Interval|Median
698189|NCT01359410|Secondary|Occurrence of Any Fistula as Defined by the ISGPF Pancreatic Leak Grading System||100 days or removal of drain|(1) participant in the mesh reinforcement arm was not evaluable due to death and (1) participant in the non-mesh reinforcement arm was not evaluable due to death.||Participants|||Count of Participants
732569|NCT00411216|Secondary|Symptoms Intensity for Dizziness, Oscillopsia, Disequilibrium|visual analoque scales|pre-intervention, 2 weeks, 4 weeks and at discharge||||||
698190|NCT01359410|Primary|Clinically Significant Postoperative Pancreatic Leak at Any Time as Defined by the ISGPF Pancreatic Leak Grading System|"Identified as being a grade B or grade C fistula or any fistula that altered the patients' management in any way
Determination of severity of pancreatic fistula was done using the ISGPF(International Study Group Pancreatic Fistula) leak/fistula/pancreatic occlusion failure
Grade B: >3x normal serum amylase, often well clinical condition, yes/no specific treatment, negative/positive ultrasound/CT, usually persistent drainage (>3 weeks), yes/no signs of infection, yes/no readmission, no sepsis, no reoperation, no death related to fistula
Grade C: >3x normal serum amylase, ill appearing/bad, requires specific treatment, positive ultrasound/CT, persistent drainage (>3 weeks), signs of infection, yes/no readmission, sepsis, reoperation, and death related to fistula"|100 days or removal of drain|(1) participant in the mesh reinforcement arm was not evaluable due to death and (1) participant in the non-mesh reinforcement arm was not evaluable due to death.||Participants|||Count of Participants
698191|NCT01359371|Secondary|Estimate the Costs of Implementing the Volunteer Peer Telephone Counseling Including Cost Per Patient and Cost Per Quit.||Collect cost of labor data and number of hours spent by the volunteers providing peer telephone counseling.||||||
698192|NCT01359371|Secondary|Evaluate Satisfaction With Program, Barriers and Facilitators to Implementation and Participating in the Program, and Quality of the Counseling||Interviews with patients, volunteers, and staff; observing volunteer phone calls||||||
698193|NCT01359371|Secondary|Determine if There Were Differences in Quit Rates Between Those That do and do Not Participate in the Peer Telephone Cessation Counseling.||7-day point prevalence quit rate on 60-day survey||||||
698194|NCT01359371|Primary|Determine Differences in the Demographics, Health Characteristics, and Smoking Characteristics of Those Who Were Reached 3-4 Times and Those Who Were Reached 0-2 Times for Peer Telephone Counseling.|Bivariate relationships between number of times a veteran was reached by the volunteer and smoking outcomes as well as other covariates were calculated, using Wald chi-square tests for differences in proportions.|60-day survey - one survey, completed 60 days after discharge|At 60-days after in-patient discharge, seven-day point-prevalence quit rates were higher for those reached 3-4 times.||participants|||Number
698195|NCT01359254|Secondary|Survival at Day 100|Percent of subjects who are alive 100 days after the stem cell infusion|100 days|The only enrolled patient failed to complete the study due to death.|||||
698196|NCT01359254|Primary|Cord Blood Engraftment by Day 100|"Percent of subjects with cord blood engraftment on or before day 100. Detectable cord blood engraftment should be present by day 100 in at least 50% of patients.
As of 44 days post-transplant, only haploidentical donor chimerism achieved in the one patient enrolled in the Fludarabine, melphalan, and ATG arm. There were no cord cells detected for this patient."|100 days|The only enrolled patient failed to complete the study due to death.|||||
698197|NCT01359150|Secondary|Geometric Mean Titer (GMT) of Anti-Influenza Antibody|Antibody geometric mean titer (GMT) for 3 influenza antigens antigens (B, H1N1, H3N2) as measured by geometric mean of three independent determinations of the antibody response of that antigen. GMT and corresponding 2-sided 95% confidence intervals (CI) were evaluated.|Day 64 (EOS)|Evaluable immunogenicity population:eligible,randomized participants;who met rheumatoid arthritis disease activity criteria;received vaccination as scheduled and >=80% study drug;had pre and post-vaccination blood draw;complete set of assay results;had no major protocol violations.||titer||95% Confidence Interval|Geometric Mean
698198|NCT01359150|Secondary|Geometric Mean Concentrations (GMC) of Anti-Pneumococcal Antibody|Antibody geometric mean concentration (GMC) for 12 pneumococcal antigens (1, 3, 4, 5, 6B, 7F, 9V, 14, 19A, 19F, 23F, 18C) as measured by geometric mean of three independent determinations of the antibody response of that antigen. GMC and corresponding 2-sided 95% confidence intervals (CI) were evaluated.|Day 64 (EOS)|Evaluable immunogenicity population:eligible,randomized participants;who met rheumatoid arthritis disease activity criteria;received vaccination as scheduled and >=80% study drug;had pre and post-vaccination blood draw;complete set of assay results;had no major protocol violations.||microgram/milliliter (mcg/mL)||95% Confidence Interval|Geometric Mean
698199|NCT01359150|Secondary|Geometric Mean Fold Rise (GMFR) of Anti-Influenza Antibody Levels to Each of the Influenza Antigens Above Vaccination Baseline Values (Day 29)|GMFRs for the 3 influenza antigens (B, H1N1, H3N2) from pre-vaccination (Day 29) to Day 64 (Day 35 post-vaccination) were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers. Data was stratified by the background methotrexate use.|Day 64 (EOS)|Evaluable immunogenicity population:eligible,randomized participants;who met rheumatoid arthritis disease activity criteria;received vaccination as scheduled and >=80% study drug;had pre and post-vaccination blood draw;complete set of assay results;had no major protocol violations.n=participants evaluable at specified categories for each arm group.||fold rise||95% Confidence Interval|Geometric Mean
698200|NCT01359150|Secondary|Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29)|Geometric mean fold rises (GMFRs) for the 12 pneumococcal antigens (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) from pre-vaccination (Day 29) to Day 64 (Day 35 post-vaccination) were computed using the logarithmically transformed assay results. Confidence intervals (CIs) for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers. Data was stratified by the background methotrexate use.|Day 64 (EOS)|Evaluable immunogenicity population:eligible,randomized participants;who met rheumatoid arthritis disease activity criteria;received vaccination as scheduled and >=80% study drug;had pre and post-vaccination blood draw;complete set of assay results;had no major protocol violations.n=participants evaluable at specified categories for each arm group.||fold rise||95% Confidence Interval|Geometric Mean
698201|NCT01359150|Secondary|Percentage of Participants With Protective Antibody Titers to the Seasonal Influenza Vaccine|Seroprotection was defined as achieving protective antibody titers to the influenza vaccine as measured by a hemagglutination inhibition (HAI) assay titer of >= 1:40 in at least 2 of 3 influenza antigens (B, H1N1, H3N2). Data was stratified by the background methotrexate use.|Day 64 (EOS)|Evaluable immunogenicity population:eligible,randomized participants;who met rheumatoid arthritis disease activity criteria;received vaccination as scheduled and >=80% study drug;had pre and post-vaccination blood draw;complete set of assay results;had no major protocol violations.n=participants evaluable at specified categories for each arm group.||percentage of participants||95% Confidence Interval|Number
732570|NCT00411216|Secondary|Activities Specific Balance Confidence Scale|questionnaire|pre-intervention, 2 weeks, 4 weeks and at discharge||||||
698202|NCT01359150|Secondary|Percentage of Participants Who Responded to Each of the 3 Influenza Antigens|Response to the influenza vaccine (seroconversion) was defined as >= 4 fold increase in antibody titers from vaccination baseline (Day 29) in each of 3 influenza antigens (B, H1N1, H3N2). Data was stratified by the background methotrexate use.|Day 64 (EOS)|Evaluable immunogenicity population:eligible,randomized participants;who met rheumatoid arthritis disease activity criteria;received vaccination as scheduled and >=80% study drug;had pre and post-vaccination blood draw;complete set of assay results;had no major protocol violations.n=participants evaluable at specified categories for each arm group.||percentage of participants||95% Confidence Interval|Number
698203|NCT01359150|Secondary|Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens|Response to the pneumococcal vaccine (seroconversion) was defined as >= 2 fold increase in antibody concentrations from vaccination baseline (Day 29) in each of the 12 pneumococcal antigens (1, 3, 4, 5, 6B, 7F, 9V, 14, 19A, 19F, 23F, 18C). Data was stratified by the background methotrexate use.|Day 64 (EOS)|Evaluable immunogenicity population:eligible,randomized participants;who met rheumatoid arthritis disease activity criteria;received vaccination as scheduled and >=80% study drug;had pre and post-vaccination blood draw;complete set of assay results;had no major protocol violations.n=participants evaluable at specified categories for each arm group.||percentage of participants||95% Confidence Interval|Number
698204|NCT01359150|Primary|Percentage of Participants With Satisfactory Humoral Response to the Seasonal Influenza Vaccine at Visit 3 (Day 64)|Satisfactory humoral response to the influenza vaccine was defined as >= 4 fold increase in antibody titers from vaccination baseline (Day 29) in at least 2 of 3 influenza antigens (B, H1N1, H3N2). Data was stratified by the background methotrexate use.|Day 64 (EOS)|Evaluable immunogenicity population:eligible,randomized participants;who met rheumatoid arthritis disease activity criteria;received vaccination as scheduled and >=80% study drug;had pre and post-vaccination blood draw;complete set of assay results;had no major protocol violations.n=participants evaluable at specified categories for each arm group.||percentage of participants||95% Confidence Interval|Number
698205|NCT01359150|Primary|Percentage of Participants With Satisfactory Humoral Response to the Pneumococcal Vaccine at Visit 3 (Day 64)|Satisfactory humoral response to the pneumococcal vaccine was defined as greater than or equal to (>=) 2 fold increase in antibody concentrations from vaccination baseline (Day 29) in at least 6 of 12 pneumococcal antigens (1, 3, 4, 5, 6B, 7F, 9V, 14, 19A, 19F, 23F, 18C). Data was stratified by the background methotrexate use.|Day 64 (End of Study [EOS])|Evaluable immunogenicity population:eligible,randomized participants;who met rheumatoid arthritis disease activity criteria;received vaccination as scheduled and >=80% study drug;had pre and post-vaccination blood draw;complete set of assay results;had no major protocol violations.n=participants evaluable at specified categories for each arm group.||percentage of participants||95% Confidence Interval|Number
698206|NCT01359111|Secondary|Proportion of Injections Administered With Needle Bevel up and Needle Bevel Down Delivered to the Intradermal Layer of the Skin.|The proportion of saline injections administered with the ID Adapter with needle bevel oriented up and needle bevel oriented down resulting in delivery to the intradermal layer of the skin. This will be assessed by visualization of intradermal wheals with diameters ≥ 5mm, the volume of liquid injected, and confirmation of delivery to the intradermal layer by ultrasound.|1 day|||percentage of injections|Participants||Number
698207|NCT01359111|Secondary|Proportion of Participants With Safety Events|The proportion of participants with safety events will be calculated for events occurring within 30 minutes and within 48 hours of injection.|2 days|||percentage of participants|||Number
698208|NCT01359111|Primary|Proportion of Injections Delivered to the Intradermal Layer of the Skin|The proportion of saline injections via the ID Adapter resulting in delivery to the intradermal layer of the skin will be assessed by visualization of intradermal wheals with diameters ≥ 5mm, the volume of liquid injected, and confirmation of delivery to the intradermal layer by ultrasound.|1 day|||percentage of injections|Participants||Number
698209|NCT01358864|Secondary|AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, SVR12=YES|The number of participants with aspartate aminotransferase (AST) in normal range post treatment when patients have sustained virological response 12 weeks post treatment. BL=baseline|12 weeks post treatment, up to 60 weeks|FAS||participants|||Number
698210|NCT01358864|Secondary|AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, When SVR12=NO|The number of participants with aspartate aminotransferase (AST) in normal range post treatment when patients do not have sustained virological response 12 weeks post treatment. BL=baseline|12 weeks post treatment, up to 60 weeks|FAS||participants|||Number
698211|NCT01358864|Secondary|ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, SVR12=YES|The number of participants with alanine aminotransferase (ALT) in normal range post treatment when patients have sustained virological response 12 weeks post treatment. BL=baseline|12 weeks post treatment, up to 60 weeks|FAS||participants|||Number
698212|NCT01358864|Secondary|ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, When SVR12=NO|The number of participants with alanine aminotransferase (ALT) in normal range post treatment when patients do not have sustained virological response 12 weeks post treatment. BL=baseline|12 weeks post treatment, up to 60 weeks|FAS||participants|||Number
698213|NCT01358864|Secondary|AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=YES|The number of participants with aspartate aminotransferase (AST) in normal range at the end of treatment (EoT) when patients have sustained virological response 12 weeks post treatment. BL=baseline|End of treatment, up to 48 weeks|FAS||participants|||Number
698214|NCT01358864|Secondary|AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=NO|The number of participants with aspartate aminotransferase (AST) in normal range at the end of treatment when patients do not have sustained virological response 12 weeks post treatment. BL=baseline|End of treatment, up to 48 weeks|FAS||participants|||Number
698215|NCT01358864|Secondary|ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=YES|The number of participants with alanine aminotransferase (ALT) in normal range at the end of treatment when patients have sustained virological response 12 weeks post treatment. BL=baseline|End of treatment, up to 48 weeks|FAS||participants|||Number
698216|NCT01358864|Secondary|ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=NO|The number of participants with alanine aminotransferase (ALT) in normal range at the end of treatment (EoT) when patients do not have sustained virological response 12 weeks post treatment. BL=baseline|End of treatment, up to 48 weeks|FAS||participants|||Number
732571|NCT00411216|Secondary|Disability Scale|questionnaire|pre-intervention, 2 weeks, 4 weeks and at discharge||||||
698220|NCT01358825|Primary|Number of Subjects With Anti-HBs Antibody Concentrations ≥ 6.2 mIU/mL|Cut-off values assessed were greater than or equal to 6.2 milliinternational units per millilitre ( mIU/mL) in the sera of subjects seronegative before vaccination.|At Day 0|The analysis was performed on the According-To-Protocol (ATP) Cohort, which included all subjects with blood sample available and who met all the eligibility criteria, complying with the procedure defined in the protocol and with no elimination code assigned.||Subjects|||Number
698221|NCT01358825|Primary|Number of Subjects With Serious Adverse Events (SAEs).|Assessed SAEs include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (up to Day 46)|The analysis was performed on the Total Cohort, which included all subjects enrolled in the study.||Subjects|||Number
698222|NCT01358825|Primary|Concentrations of Antibodies Against Anti-PRP.|Concentrations are presented as geometric mean concentrations (GMCs), expressed in micrograms per millilitre (μg/mL).|At Day 0|The analysis was performed on the According-To-Protocol (ATP) Cohort, which included all subjects with blood sample available and who met all the eligibility criteria, complying with the procedure defined in the protocol and with no elimination code assigned.||μg/mL||95% Confidence Interval|Geometric Mean
698223|NCT01358825|Primary|Number of Seroprotected Subjects Against Anti-polyribosyl Ribitol Phosphate (Anti-PRP).|A seroprotected subject is a subject with anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (μg/mL)|At Day 0|The analysis was performed on the According-To-Protocol (ATP) Cohort, which included all subjects with blood sample available and who met all the eligibility criteria, complying with the procedure defined in the protocol and with no elimination code assigned.||Subjects|||Number
698224|NCT01358825|Primary|Concentrations of Antibodies Against Anti-HBs.|Concentrations are presented as geometric mean concentrations (GMCs), expressed in milliinternational units per millilitre (mIU/mL).|At Day 0|The analysis was performed on the According-To-Protocol (ATP) Cohort, which included all subjects with blood sample available and who met all the eligibility criteria, complying with the procedure defined in the protocol and with no elimination code assigned.||mIU/mL||95% Confidence Interval|Geometric Mean
698225|NCT01358825|Primary|Number of Seroprotected Subjects Against Anti-hepatitis B Surface Antigen (Anti-HBs).|Seroprotection = anti-HBs antibody concentration ≥ 10 milli-international units per milliliter (mIU/mL).|At Day 0|The analysis was performed on the According-To-Protocol (ATP) Cohort, which included all subjects with blood sample available and who met all the eligibility criteria, complying with the procedure defined in the protocol and with no elimination code assigned.||Subjects|||Number
698226|NCT01358825|Primary|Concentrations of Antibodies Against Anti-PT, Anti-FHA and Anti-PRN.|Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EL.U/mL).|At Day 0|The analysis was performed on the According-To-Protocol (ATP) Cohort, which included all subjects with blood sample available and who met all the eligibility criteria, complying with the procedure defined in the protocol and with no elimination code assigned.||EL.U/mL||95% Confidence Interval|Geometric Mean
698227|NCT01358825|Primary|Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Antifilamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations ≥5 ELISA Units Per Milliliter (EL.U/mL).|Cut-off values assessed were greater than or equal to 5 ELISA units per millilitre (EL.U/mL) in the sera of subjects seronegative before vaccination.|At Day 0|The analysis was performed on the According-To-Protocol (ATP) Cohort, which included all subjects with blood sample available and who met all the eligibility criteria, complying with the procedure defined in the protocol and with no elimination code assigned.||Subjects|||Number
698228|NCT01358825|Primary|Concentrations of Antibodies Against Anti-D and Anti-T|Concentrations are presented as geometric mean concentrations (GMCs), expressed in milliinternational units per millilitre (mIU/mL).|At Day 0|The analysis was performed on the According-To-Protocol (ATP) Cohort, which included all subjects with blood sample available and who met all the eligibility criteria, complying with the procedure defined in the protocol and with no elimination code assigned.||IU/mL||95% Confidence Interval|Geometric Mean
698229|NCT01358825|Primary|Number of Seroprotected Subjects Against Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T).|A seroprotected subject is a subject with anti-D/anti-T antibody concentrations greater than (≥) or equal to 0.1 international units per milliliter (IU/mL)|At Day 0|The analysis was performed on the According-To-Protocol (ATP) Cohort, which included all subjects with blood sample available and who met all the eligibility criteria, complying with the procedure defined in the protocol and with no elimination code assigned.||Subjects|||Number
698230|NCT01358760|Secondary|Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color|To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, the vaginal color (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.||Severity score||Standard Error|Mean
698231|NCT01358760|Secondary|Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness|To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, the vaginal epithelial surface thickness (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.||Severity score||Standard Error|Mean
698299|NCT01357980|Secondary|Pain Visual Analogue Scale (VAS) Score: During Treatment Injection Procedure|Pain assessment using the VAS. The VAS is a 100-mm (10-cm) scoring scale. Score range on VAS is from 0 to 100 where zero [0] indicates no pain and 100 indicates worst possible pain.|Baseline|Analysis based on number of subjects in the Safety population with a valid value.||mm||Standard Deviation|Mean
724205|NCT00336700|Primary|Recurrence Free Survival (RFS)|The time interval between day 1, cycle 1, of adjuvant treatment to the first date of radiologic recurrence or death.|Up to 60 months|||months||95% Confidence Interval|Median
698232|NCT01358760|Secondary|Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity|To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, the vaginal epithelial integrity (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.||Severity score||Standard Error|Mean
698233|NCT01358760|Secondary|Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions|To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, the vaginal secretions (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy were analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.||Severity score||Standard Error|Mean
698234|NCT01358760|Secondary|Change From Baseline to Week 12 in Severity of Dyspareunia|The severity of dyspareunia was evaluated by a questionnaire filled out by women. The severity of dyspareunia recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Efficacy analyses on dyspareunia were performed on a subgroup of the Intent to Treat (ITT) population (defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria) who had self-identified moderate to severe dyspareunia at Baseline.||Severity score||Standard Error|Mean
698235|NCT01358760|Primary|Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness|The severity of vaginal dryness was evaluated by a questionnaire filled out by women. The severity of dryness recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.||Severity score||Standard Error|Mean
698236|NCT01358760|Primary|Change From Baseline to Week 12 in Vaginal pH|A pH strip fixed on an Ayre spatula (or equivalent) was applied directly to the lateral wall of the vagina. The change in color of the pH indicator strip was compared to the color chart for pH evaluation. The corresponding pH value (with one decimal) was recorded. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.||pH units||Standard Error|Mean
698237|NCT01358760|Primary|Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear|The percentage of superficial cells was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.||percentage of superficial cells||Standard Error|Mean
698238|NCT01358760|Primary|Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear|The percentage of parabasal cells was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.||percentage of parabasal cells||Standard Error|Mean
698239|NCT01358734|Other Pre-specified|Percentage of Participants Alive at One Year|Percentage of participants who survived at one year|Up to 12 months|ITT||Percentage of participants||95% Confidence Interval|Number
698240|NCT01358734|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAE)|TEAEs were defined as those events that started on or after the first day of study drug up until 28 days after the last dose of study drug; Serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability; is a congenital anomaly/birth defect; constitutes an important medical event. Severity of AEs were graded based upon the participants symptoms according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0); and according to the scale: Grade (Gr) 1 = Mild - transient or mild discomfort; no medical intervention required; Grade 2 = Moderate - mild to moderate limitation in activity; Grade 3 = Severe; Grade 4 = Life threatening; Grade 5 = Death|Up to data cut-off of 01 May 2015; 36 months and 4 days|Safety population includes all participants who have received at least 1 dose of Investigational Product (IP).||participants|||Number
698241|NCT01358734|Secondary|Percentage of Participants With 30-day Treatment-related Mortality|30-day mortality rate is defined as death from any cause within 30 days after first dose.|30 days|ITT includes all randomized participants||percentage of participants|||Number
698242|NCT01358734|Secondary|Relapse-Free Survival (RFS)|Relapse-free survival is defined only for participants who achieve a CR or CRi and is measured as the interval from the date of first documented leukemia-free state (defined as less than 5% blasts in an aspirate sample) to the date of leukemia relapse, death from any cause, whichever occurs first, censoring at the last visit date for participants alive in continuous CR or CRi.|Up to 74 months||04/2019||||
732572|NCT00411216|Primary|Subjective Complaints: (All Pre- and Post-intervention):|questionnaire|pre-intervention, 2 weeks, 4 weeks and at discharge||||||
698245|NCT01358734|Secondary|Percentage of Participants With an Overall Response Rate (CR +CRi+ PR)|Morphologic complete remission (CR) is defined as a leukemia-free state defined as less than 5% blasts in a one marrow aspirate with spicules and with at least 200 nucleated cells (there should be no blasts with Auer rods) AND an absolute neutrophil count (ANC) of ≥ 1 x 10^9/L, a platelet count ≥ 100 x 10^9/L, no transfusions for 1 week prior to each assessment. No duration of these findings is required for confirmation of this response. Morphologic complete remission with incomplete blood count recovery (CRi) is defined as a morphologic complete remission but the ANC may be < 1 x 10^9/L and/or the platelet count may be < 100 x 10^9/L. Partial remission (PR) is defined as an ANC > 1 x 10^9/L and platelet count ≥ 100 x 10^9/L with a > 50% decrease in the percentage of bone marrow blasts to 5% to 25% (a blast count value of ≤ 5% may also be considered a partial remission if Auer rods are present).|Up to 74 months||04/2019||||
698246|NCT01358734|Secondary|Cytogenetic Complete Remission Rate (CRc)|The CRc response category is comprised of the subset of participants who had abnormal ctyogenetics at baseline and subsequently achieved CR during treatment in conjunction with a reversion to a normal karyotype. For the primary definition of CRc, a normal karyotype is defined as no clonal abnormalities after review of at least 10 metaphases using conventional cytogenetic techniques. Cytogenetic complete remission rate (CRc) 1) CR criteria met AND 2) Abnormal karyotype present at baseline AND 3) Reversion to normal karyotype at time of CR (based on ≥ 10 metaphases), where date of cytogenetic sample = date of BM sample used for the CR assessment|Up to 74 months||04/2019||||
698247|NCT01358734|Secondary|Duration of Remission (DoR)|Duration of remission defined as the time from the date a response of CR or CRi is first documented until the date the participant has documented relapse after CR or CRi or dies from any cause, whichever occurs first.|Up to 74 months||04/2019||||
698248|NCT01358734|Secondary|Remission Rate (CR + CRi)|Remission Rate was defined as CR + CRi). Morphologic complete remission (CR) was defined as a leukemia-free state defined as less than 5% blasts in a bone marrow aspirate with bone marrow spicules and with at least 200 nucleated cells (there should be no blasts with Auer rods or persistence of extra-medullary disease) AND an absolute neutrophil count (ANC) of > 1 x 10^9/L, a platelet count ≥ 100 x 10^9/L, and Red Blood Cell transfusion (RBC) independence (no RBC transfusions for 1 week before each assessment). Morphologic complete remission with incomplete blood count recovery (CRi) was defined as a morphologic complete remission but the ANC (Absolute Neutrophil Count) may be < 1 x 10^9/L or plateletsmay be < 100 x 10^9/L.|Up to 74 months||04/2019||||
698249|NCT01358734|Primary|Kaplan Meier Estimates for One Year Survival|Overall Survival (OS) was defined as the time from randomization to death from any cause. OS was calculated using the date of randomization and date of death, or date of last follow-up for censored participants.|Up to 24 months|ITT included all randomized participants||months||95% Confidence Interval|Median
698250|NCT01358708|Secondary|Use of Rescue Medication During the Double-Blind and Open-Label Treatment Phases of the Study|Number of subjects using rescue medication (bisacodyl or loperamide) during each treatment phase of the study|8 weeks|Analysis conducted on the Intent-to-Treat population for both treatment phases||participants|||Number
698251|NCT01358708|Secondary|Stool Characteristics During the Open-Label Treatment Phase Using the BSFS|The Bristol Stool Form Scale (BSFS) score ranges from 1 to 7 from hard (score of 1) to watery (score of 7). Data are presented as the mean of daily assessments over a week.|Daily assessment|Analysis conducted on the Intent-to-Treat population defined as all subjects randomized to double-blind treatment and who subsequently entered the Open-Label Treatment Phase ; observed case (OC) data with no imputation made; baseline defined as the last non-missing assessment prior to the first dose of double-blind study medication||units on a scale (from 1 to 7)||Standard Deviation|Mean
698252|NCT01358708|Secondary|Symptom Severity During the Open-Label Treatment Phase Using the IBS Symptom Severity Scale (IBS-SSS) Total Score|The IBS-SSS has five questions related to four domains: abdominal pain severity and duration, abdominal distension, dissatisfaction with bowel habit and quality of life. The IBS-SSS score ranges from 0 (best outcome) to 500 (worst outcome).|Weekly assessment (every 7 days)|Analysis conducted on the Intent-to-Treat population defined as all subjects randomized to double-blind treatment and who subsequently entered the Open-Label Treatment Phase; observed case (OC) data with no imputation made; baseline defined as the last non-missing assessment prior to the first dose of double-blind medication.||units on a scale (from 0 to 500)||Standard Deviation|Mean
698253|NCT01358708|Secondary|Hospital Anxiety and Depression Scale (HADS) Score During the Double-Blind Phase|The HADS has 14 questions related to 2 domains: Anxiety subscale (7 questions) and Depression subscale (7 questions). Each question is graded from 0 (best outcome) to 3 (worst outcome), for a total score ranging from 0 (best outcome) to 42 (worst outcome).|At Screening and End of Double-Blind Treatment Phase|Analysis conducted on the Intent-to-Treat population defined as all randomized subjects; observed case (OC) data with no imputation made||units on a scale (from 0 to 42)||Standard Deviation|Mean
698254|NCT01358708|Secondary|Stool Characteristics During the Double-Blind Treatment Phase Using the Bristol Stool Form Scale|The Bristol Stool Form Scale score ranges from 1 to 7 from hard (score of 1) to watery (score of 7). Data are presented as the mean of daily assessments over a week.|Daily assessment|Analysis conducted on the Intent-to-Treat population defined as all randomized subjects; observed case (OC) data with no imputation made. Number of participants analyzed refers to number of participants at Baseline.||units on a scale (from 1 ato 7)||Standard Deviation|Mean
698255|NCT01358708|Secondary|Symptom Severity During the Double-Blind Treatment Phase Using the IBS Symptom Severity Scale (IBS-SSS) Total Score|The IBS-SSS has five questions related to four domains: abdominal pain severity and duration, abdominal distension, dissatisfaction with bowel habit and quality of life. The IBS-SSS score ranges from 0 (best outcome) to 500 (worst outcome).|Weekly assessment (every 7 days)|Analysis conducted on the Intent-to-Treat population defined as all randomized subjects; observed case (OC) data with no imputation made. Number of participants analyzed refers to number of participants at Baseline.||units on a scale (from 0 to 500)||Standard Deviation|Mean
698300|NCT01357980|Secondary|Pain Visual Analogue Scale (VAS) Score: Before Treatment Injection|Pain assessment using the VAS. The VAS is a 100-mm (10-cm) scoring scale. Score range on VAS is from 0 to 100 where zero [0] indicates no pain and 100 indicates worst possible pain.|Baseline|Analysis based on number of subjects in the Safety population with a valid value.||mm||Standard Deviation|Mean
699127|NCT01348139|Secondary|Cmax: Maximum Plasma Concentration|Maximum plasma concentration (Cmax) for AZD3199 doses|0 - 120 hrs for first two treatment visit 2 and 3 and 0 - 48 hrs for other treatment visits.|PK analysis set||nmol/L||Standard Deviation|Mean
698256|NCT01358708|Secondary|Global Assessment of Relief During the Open-Label Treatment Phase Using the Subject Global Assessment (SGA)|"Subjects were considered as responders if they had answered Yes to the following question at least 50% of the time during the 4-week treatment phase: Over the past week, do you consider that you have had satisfactory relief from your IBS symptoms?"|Weekly Assessment (every 7 days)|Analysis conducted on the Intent-to-Treat population defined as all subjects randomized to double-blind treatment and who subsequently entered the Open-Label Treatment Phase; observed case (OC) data with no imputation made; SGA data not available for one patient so that the analysis was performed on 16 rather than 17 patients||percentage of participants|||Number
698257|NCT01358708|Primary|Global Assessment of Relief During the Double-Blind Treatment Phase Using the Subject Global Assessment (SGA)|"Subjects were considered as responders if they had answered “Yes” to the following question at least 50% of the time during the 4-week treatment phase: “Over the past week, do you consider that you have had satisfactory relief from your IBS symptoms?"|Weekly Assessment (every 7 days)|Analysis conducted on the Intent-to-Treat population defined as all randomized subjects; observed case (OC) data with no imputation made||percentage of participants|||Number
698258|NCT01357551|Secondary|Estimated Metabolic Minutes of Moderate Physical Activity Per Week|self-reported based on short form of International Physical Activity Questionnaire|56 weeks|||metabolic minutes per week||Standard Deviation|Mean
698259|NCT01357551|Secondary|Estimated Metabolic Minutes of Walking Per Week|self-reported based on short form of International Physical Activity Questionnaire|56 weeks|||metabolic minutes per week||Standard Deviation|Mean
698260|NCT01357551|Secondary|Estimated Daily Caloric Intake|Based on self-report using Block Brief Food Frequency Questionnaire|56 weeks|||kcal per day||Standard Deviation|Mean
698261|NCT01357551|Primary|Weight||56 weeks post-randomization|||kilograms||Standard Deviation|Mean
698262|NCT01358578|Secondary|Number of Participants Developing Anti-secukinumab Antibodies|Describes the number of participants tested positive for anti-secukinumab antibodies. It refers to the number of patients who had no positive values at baseline but developed them only after start of active study treatment (AIN457 or etanercept)|60 weeks|Full Analysis Set||# participants tested positive|||Number
698263|NCT01358578|Secondary|Change From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Etanercept|The Psoriasis Symptom Diary©, a 16-item patient reported outcome (PRO) measure developed and validated in accordance with the FDA PRO Guidance (FDA Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims, 2009), demonstrated favorable psychometric properties and usefulness for treatment efficacy evaluation alongside other measures of disease severity in clinical trials for chronic plaque psoriasis.Weekly averages will be derived for each of the 16 questions of the Psoriasis Diary up to Week 12. A weekly average is the sum of the scored item over the course of the study week divided by the number of days on which the item was completed and will be set to missing if four or more daily assessments were missing of the corresponding question. The range for each question is 0 to 10 with the higher score depicting a more progressed disease state. A reduction in score from baseline shows efficacy|baseline to week 12|Full analysis set||Units on a scale||Standard Error|Mean
698264|NCT01358578|Secondary|Change in Score From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Placebo|The Psoriasis Symptom Diary©, a 16-item patient reported outcome (PRO) measure developed and validated in accordance with the FDA PRO Guidance (FDA Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims, 2009), demonstrated favorable psychometric properties and usefulness for treatment efficacy evaluation alongside other measures of disease severity in clinical trials for chronic plaque psoriasis.Weekly averages will be derived for each of the 16 questions of the Psoriasis Diary up to Week 12. A weekly average is the sum of the scored item over the course of the study week divided by the number of days on which the item was completed and will be set to missing if four or more daily assessments were missing of the corresponding question. The range for each question is 0 to 10 with the higher score depicting a more progressed disease state. A reduction in score from baseline shows efficacy|baseline to week 12|Full analysis set||units on scale||Standard Error|Mean
698265|NCT01358578|Secondary|Maintenance of IGA Mod 2011 0 or 1 Response After 52 Weeks of Treatment for Subjects Who Were IGA Mod 2011 0 or 1 Responders After 12 Weeks of Treatment||52 wks|Full analysis set||participants who reached goal|||Number
698266|NCT01358578|Secondary|Maintenance of PASI 75 Response at Week 52 for Patients Who Were PASI 75 Responders at Week 12 (Non-responder Imputation)||52 wks|Full analysis set||participants who reached goal|||Number
698267|NCT01358578|Secondary|Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: :IGA (Investigator’s Global Assessment) Mod 2011 With a 0 or 1 Response at Week 12|The IGA mod 2011 scale has been developed based on a previous version of the scale used in secukinumab phase II studies in collaboration with health authorities, in particular the FDA. The explanations/descriptions of the points on the scale have been improved to ensure appropriate differentiation between the points. The IGA mod 2011 used in this study is static, i.e. it refers exclusively to the subject’s disease state at the time of the assessments, and does not attempt a comparison with any of the subject’s previous disease states, whether at baseline or at a previous visit.IGA mod 2011 has a scale of 0-4 with the lower scores correlating to better performance. A score of 0= clear skin, 1= almost clear skin, 2=mild, 3=moderate,4=severe.|12 wks|FAS||participant acheiving goal|||Number
698268|NCT01358578|Secondary|Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 75 at Week 12|A 75% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 75) is the current benchmark of primary endpoints for most clinical trials of psoriasis|12 wks|FAS||participant who acheived goal|||Number
698269|NCT01358578|Secondary|Efficacy of Secukinumab Compared to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 90 at Week 12|A 90% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 90) is above current benchmark of primary endpoints for most clinical trials of psoriasis|12 wks|FAS||participant who acheived goal|||Number
698791|NCT01352585|Primary|Number of Patients With Platelet Count ≤600x10^9/L After 12 Months|A platelet count of ≤600x10^9/L after 12 months is considered at least a partial response.|1 year|The Full Analysis Set (FAS) consisted of all subjects in the Safety Set who had at least 1 post-baseline platelet count and their JAK2 mutation status was assessed. 35 patients in the FAS had a viable platelet sample.||participants|||Number
698270|NCT01358578|Primary|Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure:IGA (Investigator’s Global Assessment) Mod 2011 With a 0 or 1 Response at Week 12|The IGA mod 2011 scale has been developed based on a previous version of the scale used in secukinumab phase II studies in collaboration with health authorities, in particular the FDA. The explanations/descriptions of the points on the scale have been improved to ensure appropriate differentiation between the points. The IGA mod 2011 used in this study is static, i.e. it refers exclusively to the subject’s disease state at the time of the assessments, and does not attempt a comparison with any of the subject’s previous disease states, whether at baseline or at a previous visit.IGA mod 2011 has a scale of 0-4 with the lower scores correlating to better performance. A score of 0= clear skin, 1= almost clear skin, 2=mild, 3=moderate,4=severe.|12 wks|||participants acheiving goal|||Number
698271|NCT01358578|Primary|Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 75 (Psoriasis Area and Severity Index) .|A 75% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 75) is the current benchmark of primary endpoints for most clinical trials of psoriasis|12 wks|||participants achieving goal|||Number
698272|NCT01358526|Other Pre-specified|Responder Analysis for Subjects With a ≥ 50% Reduction in Pain Compared to Baseline|A subject’s response to treatment was defined as the percentage reduction from the screening mean pain score to the “average pain over the last 24 hours” score for week 12 of the double-blind period.|Week 12|The full analysis population for efficacy (N = 600) was the group of subjects who were randomized and received at least 1 dose of double-blind study drug||participants (responders)|||Number
698273|NCT01358526|Other Pre-specified|Responder Analysis for Subjects With a ≥ 30% Reduction in Pain Compared to Baseline|A subject’s response to treatment was defined as the percentage reduction from the screening mean pain score to the “average pain over the last 24 hours” score for week 12 of the double-blind period.|Week 12|The full analysis population for efficacy (N = 600) was the group of subjects who were randomized and received at least 1 dose of double-blind study drug||participants (responders)|||Number
698274|NCT01358526|Secondary|Patient Global Impression of Change (PGIC)|"The PGIC observational scale was completed by the subject. Subjects were asked to assess the change in overall status relative to the start of the study. The scale has only 1 item, which measures global change of overall status by the subject on a 7-point scale (Very much improved, Much improved, Minimally improved, No change, Minimally worse, Much worse, Very much worse), where 1 = very much improved and 7 = very much worse. The proportion of subjects responding much improved and very much improved was summarized by treatment group and compared between groups using an exact test."|Week 12|The full analysis population for efficacy (N = 600) was the group of subjects who were randomized and received at least 1 dose of double-blind study drug||participants (responders)|||Number
698275|NCT01358526|Secondary|The Sleep Disturbance Subscale of the MOS Sleep Scale at Weeks 4, 8, and 12|The scale consists of 12 individual items (4 sleep disturbance, 2 sleep adequacy, 1 quantity of sleep, 3 somnolence, 1 snoring, 1 shortness of breath). Only Sleep Disturbance Subscale questions 1, 3, 7, and 8 were analyzed; scores range from 0 to 100, where higher scores indicate greater sleep disturbance.|Weeks 4, 8, and 12|The full analysis population for efficacy (N = 600) was the group of subjects who were randomized and received at least 1 dose of double-blind study drug||units on a scale||95% Confidence Interval|Mean
698276|NCT01358526|Primary|The “Average Pain Over the Last 24 Hours” at Week 12 of the Double-blind Period|The “average pain over the last 24 hours” score was collected using an 11-point numerical rating scale ranging from 0 to 10; where 0=no pain and 10=pain as bad as you can imagine.|24 hours (Week 12)|The full analysis population for efficacy (N = 600) was the group of subjects who were randomized and received at least 1 dose of double-blind study drug||units on a scale (0 - 10)||Standard Error|Mean
698277|NCT01358357|Secondary|Change From Double-blind Baseline to Week 28 (LOCF) in Q-LES-Q-SF Percent Maximum Possible Score|The Q-LES-Q-SF is a 16-item self-report measure of the degree of enjoyment and satisfaction in various areas of daily living. The questionnaire was developed and validated for use in depressed outpatient subjects and has eight summary scales that reflect major areas of functioning: physical health, mood, leisure time activities, social relationships, general activities, work, household duties and school/coursework. Each item is rated on a 5-point scale, ranging from 1 (very poor) to 5 (very good). The Q-LES-Q-SF percentage maximum possible score is calculated as 100 × (Raw Score – 14 [Minimum Score]) / (70 [Maximum Score] – 14 [Minimum Score]). Higher percent maximum scores indicate better quality of life.|Double-blind Baseline to week 28|ITT Population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized. . 12 lurasidone + Li/VPA subjects and 11 placebo +Li/VPA subjects did not have post-DB baseline Q-LES-Q-SF percent maximum possible score.||units on a scale||Standard Error|Least Squares Mean
698278|NCT01358357|Secondary|Change From Double-blind Baseline to Week 28 (LOCF) in PIRS-2 Total Score|The PIRS-2 is a 2-item self-report of insomnia assessed via a computer interface. Each item is scored from 0-3. The PIRS-2 total score is calculated as the sum of the 2 items. The PIRS total score ranges from 0 to 6. Higher scores are associated with greater severity of insomnia.|Double-blind Baseline to week 28|ITT Population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized. . 7 lurasidone + Li/VPA subjects and 7 placebo +Li/VPA subjects did not have post-DB baseline PIRS-2 total score.||units on a scale||Standard Error|Least Squares Mean
698279|NCT01358357|Secondary|Change From Double-blind Baseline to Week 28 (LOCF) in SDS Total Score|The SDS is a composite of three self-rated items designed to measure the extent to which three major sectors in the patient’s life are impaired by depressive symptoms. The SDS total score is calculated as the sum of the 3 items. The SDS total score ranges from 0 to 30. Higher scores are associated with greater severity of global functional impairments. If a subject has not worked/studied at all during the past week for reasons unrelated to the disorder, the SDS total score will be set to missing.|Double-blind Baseline to week 28|ITT Population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on treatment they were randomized. 63 lurasidone + Li/VPA subjects and 57 placebo +Li/VPA subjects did not have post-DB baseline SDS total score.||units on a scale||Standard Error|Least Squares Mean
724206|NCT00336817|Other Pre-specified|Incidence of Biopsy-proven Acute Cellular Rejection During the Study Period|number of patients with ACR|12 weeks|||participants|||Number
698280|NCT01358357|Secondary|Change From Double-blind Baseline to Week 28 (LOF) in PANSS Positive Symptom (PANNS-P) Subscale Score|The PANSS-P is a subset of items in the PANSS, an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure contains seven questions to assess delusions, conceptual disorganization, hallucinations behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS-P subscale score is the sum of the 7 items and ranges from 7 through 49. A higher score is associated with greater illness severity.|Double-blind Baseline to week 28|ITT Population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized. . 6 lurasidone + Li/VPA subjects and 3 placebo +Li/VPA subjects did not have post-DB baseline PANSS-P score.||units on a scale||Standard Error|Least Squares Mean
698281|NCT01358357|Secondary|Change Fro Double-blind Baseline to Week 28 (LOCF) in QIDS-SR(16) Total Score|The QIDS-SR16 is a 16-item self-report measure of depressive symptomatology which uses a computerized assessment interface for administration. The scoring system for the QIDS-SR16 converts responses to 16 separate items into nine DSM-IV symptom criterion domains. The nine domains comprise: depressed mood (Item 5); concentration/decision making (Item 10); self outlook (Item 11); suicidal ideation (Item 12); decreased interest (Item 13); decreased energy (Item 14); sleep disturbance (initial, middle, and late insomnia or hypersomnia) (highest score of Items 1 to 4); appetite/weight disturbance (highest score of Items 6 to 9); and psychomotor disturbance (highest score of Items 15 and 16). The QIDS-SR16 total score is calculated as the sum of the 9 domain scores. The QIDS-SR16 total score ranges from 0 to 27 with a high score indicating more severe symptoms.|Double-blind Baseline to week 28|ITT population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized. 7 lurasidone + Li/VPA subjects and 7 placebo +Li/VPA subjects did not have post-DB baseline QIDS-SR16 total score.||units on a scale||Standard Error|Least Squares Mean
698282|NCT01358357|Secondary|Change From Double-blind Baseline to Week 28 (LOCF) in MADRS Total Score|The MADRS consists of 10 items, each rated on a Likert scale, from 0=Normal to 6=Most Severe. The MADRS total score is calculated as the sum of the 10 items. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity of depressive symptoms.|Double-blind Baseline to week 28|ITT population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized. 2 lurasidone + Li/VPA subjects did not have post-DB baseline MADRS total score.||units on a scale||Standard Error|Least Squares Mean
698283|NCT01358357|Secondary|Change From Double-blind Baseline to Week 28 (LOCF) in YMRS Total Score|the YMRS is an 11-item instrument used to assess the severity of mania in subjects with a diagnosis of bipolar disorder. Ratings are based on patient self-reporting, combined with clinician observation (accorded greater score). The YMRS total score is calculated as the sum of the 11 items. The YMRS total score ranges from 0 to 60. Higher scores are associated with greater severity of maia.|Double-blind Baseline to week 28|ITT population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized. . 2 lurasidone + Li/VPA subjects did not have post-DB baseline YMRS total score.||units on a scale||Standard Error|Least Squares Mean
698284|NCT01358357|Secondary|Change From Double-blind Baseline to Week 28 (LOCF) in CGI+-BP-S Depression Score|The CGI-BP-S depression score is a single value, clinician-rated assessment of depression illness severity and ranges from 1=Normal, not at all ill to 7=Among the most extremely ill patients. A higher score is associated with a greater illness severity.|Double-blind Baseline to week 28|ITT population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized. 2 lurasidone + Li/VPA subjects did not have post-DB baseline CGI-BP-S depression score.||units on a scale||Standard Error|Least Squares Mean
698285|NCT01358357|Secondary|Change From Double -Blind Baseline to Week 28 (LOCF) in CGI-BP-S Mania Score|The CGI-BP-S mania score is a single value, clinician-rated assessment of mania illness severity and ranges from 1=Normal, not at all ill to 7=Among the most extremely ill patients. A high score is associated with greater illness severity|Double-blind Baseline to week 28|ITT population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized. . 2 lurasidone + Li/VPA subjects did not have post-DB baseline CGI-BP-S mania score.||units on a scale||Standard Error|Least Squares Mean
698286|NCT01358357|Secondary|Change From Double-blind Baseline to Week 28 (LOCF) in CGI-BP-S Overall Score|The CGI-BP-S overall score is a single value, clinician-rated assessment of overall bipolar illness severity and ranges from 1=Normal, not at all ill, to 7=Among the most extremely ill patients. a higher score is associated with greater illness severity.|Double-blind Baseline to week 28|ITT population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized. 2 lurasidone + Li/VPA subjects did not have post-DB baseline CGI-BP-S overall score.||units on a scale||Standard Error|Least Squares Mean
698287|NCT01358357|Secondary|Percentage of Subjects Who Experience a Recurrence of a Manic, Mixed Manic, Hypomanic, or Depressed Episode||28 weeks|ITT population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized.||percentage of participants|||Number
698288|NCT01358357|Secondary|Time to Recurrence of a Manic, Mixed Manic, Hypomanic, or Depressed Episode||28 weeks (up to 33 weeks)|ITT population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized.||Days||95% Confidence Interval|Median
698289|NCT01358357|Secondary|Time to All-cause Discontinuation||28 weeks (up to 33 weeks)|ITT population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized.||Days||95% Confidence Interval|Median
698792|NCT01352546|Primary|Ability to Achieve Pain Free Intercourse.|Patients need to be able to transition from the use of vaginal dilators to pain free intercourse, or to be able to continue using the #5 or #6 of 6 dilators in the absence of a partner.|one year|||percentage of participants|||Number
698290|NCT01358357|Primary|Time to Recurrence of Mood Event During the Double Blind Treatment Phase|"A mood event is defined as one of the following during the double-blind phase:
(1) Fulfilled Diagnostic and Statistical Manual of Mental Disorders, 4th Ed., Text Revision (DSM-IV-TR) criteria for manic, mixed manic, hypomanic, or depressive episode. (2) Required treatment intervention for manic, mixed manic, hypomanic, or depressive symptoms with any antipsychotic (other than study drug), antidepressant, mood stabilizer (other than lithium or divalproex), anxiolytic agents, benzodiazepine (beyond dosage allowed for anxiety, agitation, or insomnia). (3) Psychiatric hospitalization for any bipolar mood episode. (4) Young Mania Rating Scale (YMRS) or Montgomery-Asberg Depression Rating Scale (MADRS) total score ≥ 18 or Clinical Global Impression Bipolar Version, Severity of Illness (CGI BP S) score ≥ 4 at 2 consecutive assessments no more than 10 days apart. (5) Discontinuation from the study because of a mood event (as determined by the Investigator)."|28 weeks (up to 33 weeks)|ITT (Intent to treat) population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized.||Days||95% Confidence Interval|Median
698291|NCT01358175|Secondary|Assessment of Responders for ASAS Partial Remission|ASAS partial remission is a composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame a value not above 2 units in each of the 4 ASAS domains on a scale of 10. In this study ASAS partial remission is used to assess the efficacy of at least one dose of secukinumab versus placebo.ASAS partial remission was defined as a VAS score of less than 2 units in each of the 4 domains of ASAS 20: participant global assessment, pain (total back pain), function and inflammation. The percentages of participants who achieved ASAS partial remission were calculated.|16 weeks|||% responders|||Number
698292|NCT01358175|Secondary|Change From Baseline in Ankylosing Spondylitis Quality of Life Questionnaire / ASQoL|ASQoL is an 18 item questionnaire that assesses disease-specific quality of life (QoL), consisting of statements that are relevant to the physical and mental conditions for a participant with AS: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each statement is answered by the participant as a 'Yes' (scored as 1) or 'No' (scored as 0). All item scores are summed to give a total score. Total score can range from 0 (good QoL) to 18 (poor QoL). In this study, ASQoL is used to assess improvement from baseline of at least one dose of secukinumab versus placebo.|baseline and 16 weeks|||units on a scale||Standard Error|Least Squares Mean
698293|NCT01358175|Secondary|Change From Baseline in Physical Function Component of the Short-form Health Survey / SF-36 PCS|SF-36 is a 36 item questionnaire which measures Quality of Life across eight domains, which are both phyically and emotionally based. Two overall summary scores, the Phyical Component Summary (PCS) and Mental Component Summary (MCS) can be computed. In this study, SF-36 PCS is used to assess improvement from baseline of at least one dose of secukinumab versus placebo.The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.|baseline, 16 weeks|||units on a scale||Standard Error|Least Squares Mean
698294|NCT01358175|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index / BASDAI|"BASDAI is a validated assessment tool using 0 through 10 scales (0 indicating no problem and 10 indicating  worst problem), to characterize six clinical domains pertaining to five major symptoms of AS perceived by the patients. Computed composite scores of 4 or greater indicate suboptimal disease control. In this study, the BASDAI is used to assess the efficacy of at least one dose of secukinumab verus placebo. To give each symptom equal weighting, the mean (average) of the two scores relating to morning stiffness is taken. The resulting 0 to 50 score is divided by 5 to give a final 0 – 10 BASDAI score. Scores of 4 or greater suggest suboptimal control of disease, and patients with scores of 4 or greater are usually good candidates for either a change in their medical therapy or for enrollment in clinical trials evaluating new drug therapies directed at Ankylosing Spondylitis."|Baseline and 16 weeks|||units on scale||Standard Error|Least Squares Mean
698295|NCT01358175|Secondary|Assessment of Responders for the SpondyloArthritis International Society ASAS 5/6 Response|ASAS 5/6 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined timeframe at least 20% improvement in score in at least 5 of a conventional set of 6 clinical domains relevent to AS and no worsening in the remaining domain. In this study, ASAS 5/6 is used to assess the efficacy of at least one dose of secukinumab against placebo.|16 weeks|||% responders|||Number
698296|NCT01358175|Secondary|Change From Baseline in Serum hsCRP|The change from baseline in hsCRP is expressed as a ratio of post-baseline to baseline values. With the ratio normalized to 1.0 at baseline, ratios less than 1.0 represent decreased postbaseline values, whereas ratios greater than 1.0 represent increased post-baseline values.|Base line and Week 16|FAS. Analysis was done on the log(e) ratio of the treatment value vs. baseline value to normalize the distribution of the hsCRP at each visit. LS Mean, SE, 95% CI and p-value are from mixed-effect model repeated measures (MMRM) with treatment, visit, TNF-alpha inhibitor status as factors, log(e) baseline and weight as covariates.||ratio||Standard Error|Least Squares Mean
698297|NCT01358175|Secondary|Assessment of Responders for the SpondyloArthritis International Society ASAS 40 Response|ASAS 40 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined timeframe at least 40% improvement in score in at least 3 of a conventional set of 4 clinical domains relevent to AS and no worsening in the fourth domain. ASAS 40 is used to assess the efficacy of at least one dose of secukinumab against placebo.|16 weeks|FAS comprised all patients who were randomized and to whom study treatment had been assigned. The efficacy analyses are based on the FAS.||% responders|||Number
698298|NCT01358175|Primary|Assessment of Responders for the SpondyloArthritis International Society / ASAS 20 Response|ASAS 20 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined timeframe at least 20% improvement in score in at least 3 of a conventional set of 4 clinical domains relevent to AS and no worsening in the fourth domain. ASAS 20 is used to assess the efficacy of at least one dose of secukinumab against placebo.|16 weeks|FAS comprised all patients who were randomized and to whom study treatment had been assigned. The efficacy analyses are based on the FAS.||% responders|||Number
724207|NCT00336817|Other Pre-specified|Incidence of Graft Loss or Death During the Study Period|number of patients|12 weeks|||participants|||Number
698301|NCT01357980|Secondary|Quality of Life (QoL) Total Summary Score|"Mean Change from Baseline in Short Form (SF)-Qualiveen Questionnaire Calculated Total Score.
The SF-Qualiveen questionnaire is a specific health related QoL questionnaire validated for urinary disorders in subjects with neurological conditions containing 8 items looking at four scales: limitations (2 items); constraints (2 items); fears (2 items) and feelings (2 items). The 8 items each having a 5-point Likert-type scale ranging from 0=“Not at all” to 4=“Extremely” for the first 6 items, from 0=“Never” to 4=“Always” for item 7 and from 0=”Always” to 4=”Never” for item 8. The score per scale has been calculated as the mean of the two items. In case of one missing item among the 2 items for a given scale, the score has not been calculated.
Total score has been calculated as the mean of all the items completed among the 8 items.
Lower scores indicate a better QoL (i.e. no limitations, fears, constraints, or negative feelings) and higher scores indicate poorer QoL."|Baseline, 14, 42 and 84|Analysis based on number of subjects in the Intent to Treat (ITT) population.||score on a scale||Standard Deviation|Mean
698302|NCT01357980|Secondary|Physician's Global Assessment Score of Treatment Response|The subject’s treatment response was assessed by the physician and graded as ‘markedly worse’, ‘much worse’, ‘worse’, ‘slightly worse’, ‘no change’, ‘slightly improved’, ‘improved’, ‘much improved’, or ‘markedly improved’.|Day 84|Analysis based on number of subjects in the Intent to Treat (ITT) population.||participants|||Number
698303|NCT01357980|Secondary|Physician's Global Assessment Score of Treatment Response|The subject’s treatment response was assessed by the physician and graded as ‘markedly worse’, ‘much worse’, ‘worse’, ‘slightly worse’, ‘no change’, ‘slightly improved’, ‘improved’, ‘much improved’, or ‘markedly improved’.|Day 42|Analysis based on number of subjects in the Intent to Treat (ITT) population.||participants|||Number
698304|NCT01357980|Secondary|Physician's Global Assessment Score of Treatment Response|The subject’s treatment response was assessed by the physician and graded as ‘markedly worse’, ‘much worse’, ‘worse’, ‘slightly worse’, ‘no change’, ‘slightly improved’, ‘improved’, ‘much improved’, or ‘markedly improved’.|Day 14|Analysis based on number of subjects in the Intent to Treat (ITT) population.||participants|||Number
698305|NCT01357980|Secondary|Urodynamics:Maximum Detrusor Pressure|Maximum Detrusor Pressure is an urodynamic parameter that is the maximum value of the pressure within the bladder which is measured during the filling phase of the urodynamic exam. Baseline urodynamics exams done at screening visit.|Baseline, Days 14, 42 and 84|Analysis based on number (n) of subjects with a valid value in the Intent-to-Treat (ITT) population for the respective treatment groups.||cm water (cm H20)||Standard Deviation|Mean
698306|NCT01357980|Secondary|Urodynamics: Maximum Cystometric Capacity|Maximum Cystometric Capacity is an urodynamic parameter that indicates the volume at which a patient feels he (she) can no longer delay release of urine from the urinary bladder. Baseline urodynamics exams done at screening visit.|Baseline, Days 14, 42 and 84|Analysis based on number (n) of subjects with a valid value in the Intent-to-Treat (ITT) population for the respective treatment groups.||mL||Standard Deviation|Mean
698307|NCT01357980|Primary|Daily Incontinence Episode Frequency (IEF)||Baseline and Day 84|Analysis based on number of subjects in the Intent to Treat (ITT) population.||episodes per day||Standard Deviation|Mean
698308|NCT01357915|Secondary|Assessment of CMV Infection by CMV Specific Desoxyribonucleic Acid (DNA) in Blood||At Month 48 and Month 60||2025||||
698309|NCT01357915|Secondary|Number of Subjects With Response for Anti-CMV Tegument IgG Antibodies|CMV infection was determined by the anti-CMV proteins antibody response, using ELISA. Data were collected for all subjects at Month 48 (M48) and Month 60 (M60) in the Vaccine group (GSK149203A S- Group). All subjects from the Reference group (GSK149203A S+ Group) were positive for the anti-CMV tegument IgG antibodies at the screening visit.|At Month 48 and Month 60|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||Participants|||Count of Participants
698310|NCT01357915|Secondary|Specific B Cell Memory Immune Response for gB|Memory B cells specific to the CMV gB antigen, as assessed by the Enzyme-linked Immunosorbent Spot (ELISPOT) method, were expressed as a frequency of the specific memory B-cells per million memory B-cells. Data were collected for all subjects at Month 48 (M48) and Month 60 (M60).|At Month 48 and Month 60|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||B cells/million cells||Inter-Quartile Range|Median
698311|NCT01357915|Secondary|Frequency of gB-specific Cluster of Differentiation (CD4+/CD8+) T-cells Expressing at Least Two Immune Markers|Among the immune markers determined by the Intracellular cytokine staining (ICS) were Interferon-gamma (INF-γ), Interleukin-2 (IL-2), Tumor necrosis factor-alpha (TNF-α), and CD40-Ligand (CD40-L). Data were collected for all subjects at Month 48 (M48) and Month 60 (M60).|At Month 48 and Month 60|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||T cells/million cells||Inter-Quartile Range|Median
698312|NCT01357915|Secondary|Avidity Towards Anti-gB IgG Antibodies|Avidity for anti-gB IgG antibodies was assessed by the ELISA Avidity index method in all subjects, at Month 48 (M48) and Month 60 (M60).|At Month 48 and Month 60|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||Avidity Index||Inter-Quartile Range|Median
698313|NCT01357915|Primary|Number of Subjects With Neutralizing Response Against Anti-CMV Antibodies||At Month 48 and Month 60||2025||||
698314|NCT01357915|Primary|Concentrations of Antibodies Against Anti-gB IgG|Anti-gB IgG antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL), as assessed by Enzyme-linked Immunosorbent Assay (ELISA). Data were collected at Month 48 (M48) and Month 60 (M60) from all subjects.|At Month 48 and Month 60|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
698401|NCT01356667|Secondary|Knowledge of Alcoholics Anonymous Concepts as a Measure of Protocol Comprehension|The General Alcoholics Anonymous Tools of Recovery (GAATOR 2.1) will be provided in order to determine and track patient's knowledge of the 12-steps during their participation in the DARTNA treatment program.|Change from Baseline in Knowledge of Alcoholics Anonymous at 12 weeks|Please be advised that this clincial trial was terminated prior to finalization of any research procedures.|||||
698315|NCT01357889|Primary|Maximum Observed Plasma Concentration (Cmax) of Albiglutide in the BE Phase|To assess the bioequivalence of the two formulations of study drug, an analysis of variance (ANOVA) model with treatment as a fixed effect was applied to the natural-log-transformed parameter Cmax estimated from the BE phase. The Process 2 treatment group (albiglutide derived from process 2) was the reference group and was compared with the Process 3 treatment group (albiglutide derived from process 3) as the test group (i.e., treatment comparisons based on the ratio of Process 3:Process 2). Blood samples for pharmacokinetic analysis were collected prior to dosing at Baseline and 24 hours (hr), 48 hr, 96 hr, 120 hr, 216 hr, 312 hr, 480 hr, and 672 hr after administration of the Baseline study medication.|Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose|Albiglutide PK Population||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
698316|NCT01357889|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to Infinity (0-inf) of Albiglutide in the Bioequivalence (BE) Phase|To assess the bioequivalence of the two formulations of albiglutide, an analysis of variance (ANOVA) model with treatment as a fixed effect was applied to the natural-log-transformed parameter AUC(0-inf) estimated from the BE Phase. AUC is a measure of how much albiglutide is in the blood at certain time points. The Process 2 treatment group (albiglutide derived from process 2) was the reference group and was compared with the Process 3 treatment group (albiglutide derived from process 3) as the test group (i.e., treatment comparisons based on the ratio of Process 3:Process 2). Blood samples for pharmacokinetic analysis were collected prior to dosing at Baseline and 24 hours (hr), 48 hr, 96 hr, 120 hr, 216 hr, 312 hr, 480 hr, and 672 hr after administration of the Baseline study medication.|Pre-dose at Baseline; 24 hours (hr), 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose|Albiglutide Pharmacokinetic (PK) Population: all participants who had sufficient samples to calculate PK parameters of albiglutide. Participants with insufficient concentration data or an unestimable terminal elimination rate constant were excluded from analysis.||nanograms*hour/milliliter||Geometric Coefficient of Variation|Geometric Mean
698317|NCT01357889|Secondary|Number of Participants With a Change From Baseline of Clinical Concern in Electrocardiogram (ECG) Values by Any On-therapy Visit|ECG parameters include heart rate, QRS interval, QTinterval, QT interval – Bazett correction (QTcB), QT interval – Fridericia correction (QTcF), RR interval, and PR interval. Criteria for values of potential concern were determined by the medical monitors. For the QRS interval, an increase of >25% when Baseline QRS >100 milliseconds (msec) and an increase of >50% when Baseline QRS <=100 msec was considered to be of clinical concern. For QTcF, a >=60 msec change from Baseline was considered to be of clinical concern. For the PR interval, an increase of >25% when Baseline PR >200 msec and an increase of >50% when Baseline PR <=200 msec was considered to be of clinical concern.|Week 1 through Week 25|Safety Population. Only those participants available at the specified time points were analyzed. Different par. may have been analyzed at different time points; the overall number of par. analyzed reflects everyone in the Safety Population.||Participants|||Number
698318|NCT01357889|Secondary|Number of Participants With the Indicated Change From the Screening Assessment in Physical Examination at Week 17|A complete physical examination was performed at Screening and at Week 17 and included evaluation of the following organ or body systems: skin (including injection site); head; eyes; ears, sose, and throat (ENT); thyroid; respiratory system; cardiovascular system; abdomen (liver, spleen); lymph nodes; central nervous system (CNT); and extremities. The assessment was categorized as improved, no change, worsened, and not done.|Screening and Week 17|Safety Population. Only participants analyzed at Week 17 are presented.||Participants|||Number
698319|NCT01357889|Secondary|Number of Participants With a Change From Baseline of Clinical Concern in Vital Signs by Any On-therapy Visit|Vital signs measured included systolic blood pressure (SBP), diastolic blood pressure (DBP), and heart rate. Criteria for values of potential concern were determined by the medical monitors. For SBP, a decrease or increase >30 millimeters of mercury (mmHg) from Baseline was considered to be of clinical concern. For DBP, a decrease or increase >20 mmHg from Baseline was considered to be of clinical concern. For heart rate, a decrease or increase >30 beats per minute (bpm) was considered to be of clinical concern.|Week 1 through Week 25|Safety Population. Only those participants available at the specified time points were analyzed.||Participants|||Number
698320|NCT01357889|Secondary|Number of Participants With a Change From Baseline of Clinical Concern in Hematology Values by Any On-therapy Visit|Criteria for values of potential concern were determined by the medical monitors. For hematocrit, a >0.1 decrease from Baseline was considered to be of clinical concern. For hemoglobin, a >25 grams per liter (g/L) decrease from Baseline was considered to be of clinical concern.|Week 1 through Week 25|Safety Population. Only those participants available at the specified time points were analyzed.||Participants|||Number
698321|NCT01357889|Secondary|Number of Participants With Indicated Adverse Events of Special Interest|Adverse events of special interest included cardiovascular events, hypoglycemic events, pancreatitis events, thyroid events, gastrointestinal (GI) events, diabetic retinopathy events, systemic allergic reactions (SAR), injection site reactions (ISR), and liver events (AEs from investigations and hepatobiliary disorders were considered).|From the time the participant consented to participate in the study through Visit 28 (Week 25) or the final follow-up visit, for participants who discontinue active participation in the study|Safety Population||Participants|||Number
698322|NCT01357889|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs. Hypoglycemic events are excluded from this table, except for serious adverse events.|From the time the participant consented to participate in the study through Visit 28 (Week 25) or the final follow-up visit, for participants who discontinued active participation in the study|Safety Population||Participants|||Number
698402|NCT01356667|Primary|Drug and Alcohol Use as a Measure of Treatment Effectiveness|Urine drug screens and breathalyzers will be obtained from patients in order to determine their recent drug and alcohol use.|Change from Baseline in Drug and Alcohol use at 6 months|Please be advised that this clincial trial was terminated prior to finalization of any research procedures.|||||
724208|NCT00336817|Secondary|Number of Participants With Neurotoxicity||12 weeks|||participants|||Number
698323|NCT01357889|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 17|This analysis used the LOCF method for missing post-Baseline FPG values. FPG values obtained after hyperglycemic rescue were treated as missing and replaced with pre-rescue values. Baseline is defined as the last available assessment on or prior to the day on which the first dose of study drug was received. Based on ANCOVA: Change = treatment + Baseline FPG + age category + weight category + background antidiabetic therapy category.|Baseline and Week 17|Efficacy Population - LOCF||millimoles per liter||Standard Error|Least Squares Mean
698324|NCT01357889|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 17|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. This analysis used the last observation carried forward (LOCF) method for missing post-Baseline HbA1c values. HbA1c values obtained after hyperglycemic rescue were treated as missing and replaced with pre-rescue values. Baseline is defined as the last available assessment on or prior to the day on which the first dose of study drug was received. Based on analysis of covariance (ANCOVA): Change = treatment + Baseline HbA1c + age category + weight category + background antidiabetic therapy category.|Baseline and Week 17|Efficacy Population - LOCF: all participants who received a dose of study medication and who had a Baseline measurement and at least 1 post-Baseline HbA1c or fasting plasma glucose (FPG) measurement. Only participants available at the specified time point were analyzed.||Percentage of HbA1c in blood||Standard Error|Least Squares Mean
698325|NCT01357889|Secondary|Apparent Volume of Distribution in the Terminal Phase of Albiglutide in BE Phase|The apparent volume of distribution in the terminal phase (V/F) of albiglutide in the BE Phase was measured. Blood samples for PK analysis were collected prior to dosing at Baseline and 24 hr, 48 hr, 96 hr, 120 hr, 216 hr, 312 hr, 480 hr, and 672 hr after administration of the Baseline study medication.|Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose|Albiglutide PK Population. Participants with insufficient concentration data or an unestimable terminal elimination rate constant were excluded from analysis.||Liters||Geometric Coefficient of Variation|Geometric Mean
698326|NCT01357889|Secondary|Apparent Clearance of Albiglutide in the BE Phase|The apparent clearance (CL/F) of albiglutide in the BE Phase was measured. Blood samples for PK analysis were collected prior to dosing at Baseline and 24 hr, 48 hr, 96 hr, 120 hr, 216 hr, 312 hr, 480 hr, and 672 hr after administration of the Baseline study medication.|Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose|Albiglutide PK Population. Participants with insufficient concentration data or an unestimable terminal elimination rate constant were excluded from analysis.||Liters per hour||Geometric Coefficient of Variation|Geometric Mean
698327|NCT01357889|Secondary|t1/2 of Albiglutide in the BE Phase|The terminal elimination half-life (t1/2) of albiglutide in the BE Phase was measured. Blood samples for PK analysis were collected prior to dosing at Baseline and 24 hr, 48 hr, 96 hr, 120 hr, 216 hr, 312 hr, 480 hr, and 672 hr after administration of the Baseline study medication.|Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose|Albiglutide PK Population. Participants with insufficient concentration data or an unestimable terminal elimination rate constant were excluded from analysis.||Hours||Geometric Coefficient of Variation|Geometric Mean
698328|NCT01357889|Secondary|Cmax of Albiglutide in the BE Phase|Cmax of albiglutide in the BE Phase was measured. Blood samples for PK analysis were collected prior to dosing at Baseline and 24 hr, 48 hr, 96 hr, 120 hr, 216 hr, 312 hr, 480 hr, and 672 hr after administration of the Baseline study medication.|Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose|Albiglutide PK Population||ng/mL||Geometric Coefficient of Variation|Geometric Mean
698329|NCT01357889|Secondary|Tmax and Tlag of Albiglutide in the BE Phase|Time of the maximum observed plasma concentration (tmax) and the observed time prior to the first quantifiable plasma concentration (tlag) of albiglutide in the BE Phase were measured. Blood samples for PK analysis were collected prior to dosing at Baseline and 24 hr, 48 hr, 96 hr, 120 hr, 216 hr, 312 hr, 480 hr, and 672 hr after administration of the Baseline study medication.|Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose|Albiglutide PK Population. Participants with insufficient concentration data or terminal elimination rate constant not estimable were excluded.||Hours||Full Range|Median
698330|NCT01357889|Secondary|AUC (0-last) and AUC (0-inf) of Albiglutide in the BE Phase|The area under the concentration-time (AUC) curve from time zero to the last quantifiable concentration (0-last) and AUC (0-inf) of albiglutide in the BE Phase were measured. AUC is a measure of how much albiglutide is in the blood at certain time points. Blood samples for PK analysis were collected prior to dosing at Baseline and 24 hr, 48 hr, 96 hr, 120 hr, 216 hr, 312 hr, 480 hr, and 672 hr after administration of the Baseline study medication.|Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose|Albiglutide PK Population. Participants with insufficient concentration data or an unestimable terminal elimination rate constant were excluded from analysis. Different par. may have been analyzed at different time points; the overall number of par. analyzed reflects everyone in the PK Population.||nanograms*hour/milliliter||Geometric Coefficient of Variation|Geometric Mean
698331|NCT01357889|Secondary|Number of Participants With Anti-albiglutide Antibody Formation at Baseline and Weeks 5, 9, 13, 17, and 25 in the Multiple-dose Phase|The presence of anti-albiglutide antibodies after repeat-dose administration was assessed using a qualified enzyme-linked immunosorbent assay. The assay involved screening, confirmation, and titration steps (tiered-testing approach). The number of participants who tested positive for anti-albiglutide antibodies are presented by visit.|Baseline, Week 5, Week 9, Week 13, Week 17, and Week 25 (Follow-up)|Safety Population: all par. who received at least 1 dose of study medication. Only those par. available at the specified time points were analyzed (represented by n= X, X in the category titles). Different par. may have been analyzed at different time points, so the overall number of par. analyzed reflects everyone in the Safety Population.||Participants|||Number
698332|NCT01357889|Secondary|Trough (Pre-dose) Plasma Concentrations of Albiglutide in the Mutiple-dose Phase (MDP)|The trough concentration of albiglutide at Week 5, Week 9, Week 13, Week 17 (EOT), and Week 25 (Follow-up) following multiple-dose administration was estimated. The time and date of sample collection pre-dose was to be recorded.|Immediately pre-dose at Week 5, Week 9, Week 13, Week 17 (End of Treatment [EOT]), and Week 25 (Follow-up)|PK Concentration Population (PKCP): participants (par.) in the MDP for whom a PK sample was collected/analyzed. Only par. available at the specified time points were analyzed (n= X, X in the category titles). Different par. may have been analyzed at different time points; the overall number of par. analyzed reflects everyone in the PKCP.||ng/mL||Standard Deviation|Mean
698333|NCT01357850|Secondary|Number of Participants With Adverse Events by the Indicated Severity|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Severity categories: Mild: an event that was easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities;Moderate: an event that was sufficiently discomforting to interfere with normal everyday activities; Severe: an event that prevents normal everyday activities.|Baseline and Week 13|All Subjects Population. Only those participants available at the specified time points were analyzed.||Participants|||Number
698334|NCT01357850|Secondary|Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Please refer to the AE/SAE section for further details.|Baseline and Week 13|All Subject Population: all randomized participants who received >= 1 dose of study medication. Only those participants available at the specified time points were analyzed.||Participants|||Number
698335|NCT01357850|Secondary|Change From Baseline in Quality of Life as Assessed by the Minnesota Living With Heart Failure Questionnaire|Minnesota living with heart failure questionnaire (MLHFQ) is a validated instrument to measure participant-reported quality of life at Baseline and Week 13. For each of 21 items, participants rated the effects of heart failure and its treatment on physical, socioeconomic and psychological aspects of their life. To measure the effects of symptoms, functional limitations, psychological distress on an individual's quality of life, the MLHF questionnaire asks each participant to indicate their response using a 6-point scale (ranging from 0 to 5, 0=no, 1=very little, and 5=very much). The min and max scores can range from 0 to 105. The likert scale measures the effect of heart failure and treatments for heart failure on an individual's ability to live as they want. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Week 13|ITT Population. Only those participants available at the specified time points were analyzed.||Scores on a scale||95% Confidence Interval|Geometric Mean
698336|NCT01357850|Secondary|Change From Baseline in Plasma Levels of Insulin|Blood samples for biomarker analysis of fasting levels of insulin were collected at Weeks 1, 7 and 13. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Week 13|ITT Population. Only those participants available at the specified time points were analyzed.||picomole per liter (pmol/L)||Standard Error|Geometric Mean
698337|NCT01357850|Secondary|Change From Baseline in Plasma Levels of Glucose, and Free Fatty Acids (FFA)|Blood samples for biomarker analysis of fasting levels of glucose and FFA were collected at Weeks 1, 7 and 13; glucose was also collected at Weeks 2, 4, 6, 8, 10, and 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Week 13|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed for different parameters at different time points, so the overall number of participants analyzed reflects everyone in the ITT population.||Millimole per liter (mmol/L)||Standard Error|Geometric Mean
698338|NCT01357850|Secondary|Change From Baseline in Serum N-terminal Fragment Brain Natriuretic Peptide (NT-BNP) Level|Baseline is defined as the last available assessment on or prior to the first dose of study medication. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Change from Baseline at Week 13|ITT Population. Only those participants available at the specified time points were analyzed.||Nanogram per liter||Standard Error|Geometric Mean
698339|NCT01357850|Secondary|Change From Baseline in Exercise Capacity Assessed by 6-minute Walk Test|The six minute walk test was performed at Baseline and Week 13. All participantss were given standardized instructions and the distance walked was measured. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Week 13|ITT Population. Only those participants available at the specified time points were analyzed.||Meters||95% Confidence Interval|Geometric Mean
698340|NCT01357850|Secondary|Change From Baseline in Cardiac and Liver Fat by Proton Spectroscopy (1H MRS)|Change in Baseline in cardiac and liver fat by proton spectroscopy was planned at Baseline and Week 13. The protocol allowed for sites to perform all or only efficacy assessments, depending on site designation, capability and feasibility. No sites that enrolled participants into this study were able to perform this outcome measure.|Baseline and Week 13||||||
698341|NCT01357850|Secondary|Change From Baseline in Cardiac Energetics (PCr/ATP) Measured by 31P Magnetic Resonance Spectroscopy (MRS)|Participants underwent a CMR scan performed on a 3 Tesla MR system at Baseline and Week 13 to assess cardiac mass, volumes (global function and dilatation), strain and torsion, cardiac and liver lipid content and cardiac energy metabolism. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Week 13|Magnetic Resonance Substudy Population (MRS): all randomized participants who participated in the MRS substudy and had valid Baseline and/or Week 13 assessments for either PCr/ATP via 31P MRS. Only those participants available at the specified time points were analyzed.||ratio||95% Confidence Interval|Least Squares Mean
698342|NCT01357850|Secondary|Change From Baseline in LV and RV Function Assessed by CMR (LV Mass), Myocardial Strain Assessed by Myocardial Tagging Indices|Non-contrast CMR to assess left/right ventricular ejection fraction, volume, mass, and strain was performed following a period of rest after exercise testing at Baseline and after the Week 13 treatment phase. A 3Tesla magnetic resonance imagine (MRI) examination was performed including sequences for evaluation of LV structure and function. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Week 13|CMR Substudy Population. Only those participants available at the specified time points were analyzed.||Grams||Standard Error|Geometric Mean
698343|NCT01357850|Secondary|Change From Baseline in LV and RV Function Assessed by CMR (LV and RV Volumes in Systole and Diastole), Myocardial Strain Assessed by Myocardial Tagging Indices|Non-contrast CMR to assess LV and RV ejection fraction, volume, mass, and strain was performed following a period of rest after exercise testing at Baseline and after the Week 13 treatment phase. A 3Tesla magnetic resonance imagine (MRI) examination was performed including sequences for evaluation of LV structure and function. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Week 13|CMR Substudy Population. Only those participants available at the specified time points were analyzed.||Milliliters||Standard Error|Geometric Mean
698344|NCT01357850|Secondary|Change From Baseline in LV and RV Function Assessed by Cardiac Magnetic Resonance (CMR) (LVEF), Myocardial Strain Assessed by Myocardial Tagging Indices|Non-contrast CMR to assess left ventricular (LV) and right ventricular (RV) ejection fraction, volume, mass, and strain was performed following a period of rest after exercise testing at Baseline and after the Week 13 treatment phase. A 3Tesla magnetic resonance imagine (MRI) examination was performed including sequences for evaluation of LV structure and function. Only those participants available at the specified time points were analyzed. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Week 13|CMR Substudy Population: all randomized participants who participated in the CMR substudy and had valid Baseline and/or Week 13 assessments for >= 1 one of the imaging parameters of LV and RV function assessed by CMR (LVEF, LV and RV volumes in systole and diastole, LV mass), myocardial strain assessed by myocardial tagging indices.||Percentage||Standard Error|Geometric Mean
698345|NCT01357850|Secondary|Change From Baseline in Left Ventricular (LV) Volumes in Systole and Diastole as Assessed by Echocardiogram|Echocardiography was performed at Baseline and Week 13 using pulse-wave, continuous-wave and tissue Doppler. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Week 13|ITT Population. Only those participants available at the specified time points were analyzed.||Milliliters||Standard Error|Geometric Mean
698346|NCT01357850|Secondary|Change From Baseline in Left Ventricular Ejection Fraction (LVEF) as Assessed by Echocardiogram|Echocardiography was performed at Baseline and Week 13 using pulse-wave, continuous-wave, and tissue Doppler. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Week 13|ITT Population. Only those participants available at the specified time points were analyzed.||Percentage||Standard Error|Geometric Mean
698347|NCT01357850|Primary|Change From Baseline in Peak Oxygen Uptake (Peak VO2) as Assessed by Bicycle Cardiopulmonary Exercise Testing|Peak VO2 was measured at Baseline and Week 13. Participants performed a maximal exercise test limited by dyspnea or fatigue on a cycle ergometer. After a rest period, the workloads were increased in a step fashion by 25 watts every 3 minutes. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on analysis using a mixed effects ANOVA model, fitting terms for treatment, visit and interaction of treatment and visit, with participants as random effects.|Baseline and Week 13|ITT Population. Only those participants available at the specified time points were analyzed.||Milliliters per kilogram per minute||95% Confidence Interval|Least Squares Mean
698348|NCT01357850|Primary|Change From Baseline in Myocardial Efficiency (Work Performed/Myocardial Oxygen Consumption [MVO2]) Assessed at Rest|MVO2 was estimated by measuring the rate of myocardial clearance of 11C-activity which represents overall myocardial oxidative flux through the TCA cycle. Cardiac work was measured by echocardiography and cardiac efficiency index was calculated as work (by echocardiography) divided by MVO2. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on analysis using a mixed effects ANOVA model, fitting terms for treatment, visit and interaction of treatment and visit, with participants as random effects.|Baseline and Week 13|ITT Population. Only those participants available at the specified time points were analyzed.||millimeters of mercury/liter/minute2||95% Confidence Interval|Least Squares Mean
698349|NCT01357850|Primary|Change From Baseline in Myocardial Glucose Utilization as Assessed by [18F]Fluoro-2-deoxy-glucose Positron Emission Tomography (FDG-PET) Imaging|FDG-PET imaging was performed at Baseline and Week 13 to assess myocardial glucose uptake. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on analysis using a mixed effects analysis of variance (ANOVA) model, fitting terms for treatment, visit and interaction of treatment and visit, with participants as random effects.|Baseline and Week 13|Intent-to-Treat (ITT) Population: all randomized participants who received >= 1 dose of study medication and had >= 1 on treatment assessment. Only those participants available at the specified time points were analyzed.||micromoles per gram per minute||95% Confidence Interval|Least Squares Mean
698350|NCT01357720|Primary|Seroprotection Rate: Anti-B. Pertussis Antibodies|Percentage of subjects with an anti-B. pertussis antibody titer ≥20 EU/mL or a 4-fold increase over baseline (i.e. seroconversion rate)|1 month after the third vaccination|Available observations at Visit 4||percentage of subjects||95% Confidence Interval|Number
698351|NCT01357720|Primary|Seroprotection Rate: Anti-tetanus Toxoid Antibodies|Percentage of subjects with antibody levels against tetanus toxoid ≥0.1 IU/mL (i.e. seroprotection rate)|1 month after the third vaccination|Available observations at Visit 4||percentage of subjects||95% Confidence Interval|Number
698352|NCT01357720|Primary|Seroprotection Rate: Anti-diphtheria Toxoid Antibodies|Percentage of subjects with antibody levels against diphtheria toxoid ≥0.1 IU/mL (i.e. seroprotection rate)|1 month after the third vaccination|Available observations at Visit 4||percentage of subjects||95% Confidence Interval|Number
698353|NCT01357720|Primary|Seroprotection Rate: Anti-hepatitis B Surface Antibodies|Percentage of subjects with an anti-hepatitis B surface antibody titer ≥10 IU/L (i.e. seroprotection rate)|1 month after the third vaccination|Available observations at Visit 4||percentage of subjects||95% Confidence Interval|Number
698354|NCT01357720|Primary|Seroprotection Rate: Anti-PRP Antibodies|Percentage of subjects with an anti-PRP titer ≥0.15 µg/mL (i.e. seroprotection rate)|1 month after the third vaccination|Available observations at Visit 4||percentage of subjects||95% Confidence Interval|Number
698403|NCT01356602|Secondary|C-reactive Protein Level|A central laboratory was used for analysis of all blood samples collected.|72 hours|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.||mg / L||95% Confidence Interval|Least Squares Mean
724209|NCT00336817|Secondary|Number of Participants With Clinically Significant Decrease in Serum Creatinine From Baseline Through Week 12|Creatinine levels|12 weeks|||participants|||Number
698355|NCT01357655|Secondary|Number of Participants Experiencing Serious Adverse Events (SAE), Drug-Related Adverse Event (AE), AE Leading to Discontinuation, and Death|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=having certain, probable, possible, or missing relationship to study drug.|From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)|All Treated Participants; Participants enrolled in this trial could not be randomized to the Dasatinib + SMO antagonist arm because no recommended phase 2 dose of the SMO antagonist could be determined (in a separate trial).||participants|||Number
698356|NCT01357655|Secondary|Transformation-free Survival Measured by the Time From Start of Treatment to Criteria for Accelerated or Blast Phase CML Are Met and Death||Baseline to End of study (approximately 48 months)|The study was terminated prior to data collection for this endpoint.|||||
698357|NCT01357655|Secondary|Event-free Survival, Measured by the Time From Start of Treatment to Progression, Death or Treatment Discontinuation||Baseline to End of study (approximately 48 months)|The study was terminated prior to data collection for this endpoint.|||||
698358|NCT01357655|Secondary|Progression-free Survival, Measured by the Time From Start of Treatment to Progression or Death||Baseline to End of study (approximately 48 months)|The study was terminated prior to data collection for this endpoint.|||||
698359|NCT01357655|Secondary|Complete Molecular Response at Any Time||Baseline to End of study (approximately 48 months)|The study was terminated prior to data collection for this endpoint.|||||
698360|NCT01357655|Primary|Number of Participants With Major Molecular Response|Major molecular response (MMR) was assessed using BCR-ABL transcript levels measured by real-time quantitative polymerase chain reaction (qPCR). MMR was defined as a ratio BCR-ABL/ABL ≤0.1% on the international scale (ie, at least 3 log reduction from a standardized baseline value). Number of participants with MMR by timepoint are cumulative.|Baseline up to 12 months|Efficacy Sample: all treated participants with at least one assessment on treatment. Participants enrolled in this trial could not be randomized to the Dasatinib + SMO antagonist arm because no recommended phase 2 dose of the SMO antagonist could be determined (in a separate trial).||Participants|||Count of Participants
698361|NCT01357616|Secondary|Mean IOP Change From Baseline (5 PM) at Week 8|Mean IOP change from baseline (5 PM) at Week 8 was measured by Goldmann applanation tonometry. One eye from each subject was chosen as the study eye, and only data for the study eye were used for the efficacy analysis. A higher IOP (fluid pressure inside the eye) can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater improvement.|Baseline, Week 8|This reporting group includes all subjects who received study medication, satisfied pre-randomization inclusion/exclusion criteria and completed at least 1 scheduled on-therapy study visit.||mmHg||Standard Deviation|Least Squares Mean
698362|NCT01357616|Secondary|Mean IOP Change From Baseline at 11 AM|Mean IOP change from baseline at 11 AM was measured by Goldmann applanation tonometry. One eye from each subject was chosen as the study eye, and only data for the study eye were used for the efficacy analysis. A higher IOP (fluid pressure inside the eye) can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater improvement.|Baseline, Up to Week 8|This reporting group includes all subjects who received study medication, satisfied pre-randomization inclusion/exclusion criteria and completed at least 1 scheduled on-therapy study visit.||mmHg||Standard Deviation|Least Squares Mean
698363|NCT01357616|Secondary|Mean IOP Change From Baseline at 9 AM|Mean IOP change from baseline at 9 AM was measured by Goldmann applanation tonometry. One eye from each subject was chosen as the study eye, and only data for the study eye were used for the efficacy analysis. A higher IOP (fluid pressure inside the eye) can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater improvement.|Baseline, Up to Week 8|This reporting group includes all subjects who received study medication, satisfied pre-randomization inclusion/exclusion criteria and completed at least 1 scheduled on-therapy study visit.||mmHg||Standard Deviation|Least Squares Mean
698364|NCT01357616|Primary|Mean Diurnal IOP Change From Baseline at Week 8|Mean diurnal IOP change from baseline at Week 8 (ie, the subject IOP change from baseline averaged over the 9 AM, 11AM and 5 PM time points at Week 8) was measured by Goldmann applanation tonometry. One eye from each subject was chosen as the study eye, and only data for the study eye were used for the efficacy analysis. A higher IOP (fluid pressure inside the eye) can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater improvement..|Baseline, Week 8|This reporting group includes all subjects who received study medication, satisfied pre-randomization inclusion/exclusion criteria and completed at least 1 scheduled on-therapy study visit.||millimeters mercury (mmHg)||Standard Deviation|Least Squares Mean
698365|NCT01357512|Secondary|Proportion of Clinically Significant Prostate Cancers Detected in MRI and no MRI Groups|Number of clinically significant prostate cancers detected with and without MRI. Clinically significant prostate cancer is determined by the Gleason grading and be the number of cancer-positive biopsy cores.|at the end of the study (up to 1 year)||||||
698366|NCT01357512|Secondary|Number of Positive Biopsies in MRI and no MRI Groups|The number of biopsies with histology confirming prostate cancer are compared between MRI and no MRI groups. This measure will clarify if prostate cancer can be diagnosed more accurately, i.e. more biopsies with confirmed prostate cancer, after MRI. Ten or 12 biopsies will be taken from prostates below 30 grams, or equal or above 30 grams, respectively.|at the end of the study (up to 1 year)|||number of cancer-positive biopsy cores||Inter-Quartile Range|Median
698367|NCT01357512|Primary|Number of Prostate Cancer Diagnoses in MRI and no MRI Groups|The number of patients with confirmed prostate cancer among men with MRI performed before biopsies are compared to the number of patients with prostate cancer confirmed in prostate biopsies without MRI. The number patients with prostate cancer are counted as total from cancers detected in random biopsies and in biopsies targeted based on suspicious MRI findings in MRI group, and from random biopsies in no MRI group.|at the end of the study (up to 1 year)|||participants|||Number
698889|NCT01350999|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs)||52 Weeks|Safety Analysis Set included all participants who received at least one dose of the investigational product.||participants|||Number
698368|NCT01357239|Secondary|Change From Baseline in Repetitive Behaviors Assessed Using the Repetitive Behavior Scale - Revised (RBS-R) Total and Subscale Scores in Stratum II|The Repetitive Behavior Scale - Revised (RBS-R) is a rating tool that captures the breadth of repetitive behavior. It is a 43-item questionnaire filled by the caregivers. Each behavior assessed is rated from 0 (behavior does not occur) to 3 (behavior occurs and it is a severe problem). The total score ranks from 0 to 129. The behaviors are grouped into six domains: ritualistic behavior (range 0 to 18); sameness behavior (range 0 to 33); stereotypic behavior (range 0 to 18); self-injurious behavior (range 0 to 24); compulsive behavior (range 0 to 24); and restricted interests (range 0 to 12). A negative change represents improvement. Stratum II included patients whose FMR1 gene was partially methylated|Baseline to week 12|Full Analysis Set (FAS):all randomized patients who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline assessment for the primary efficacy parameter. Only participants who had a value at the given time and the assessment was within the window for analysis were included||Score on a scale||Standard Error|Least Squares Mean
698369|NCT01357239|Secondary|Change From Baseline in Repetitive Behaviors Assessed Using the Repetitive Behavior Scale - Revised (RBS-R) Total and Subscale Scores in Stratum I|The Repetitive Behavior Scale - Revised (RBS-R) is a rating tool that captures the breadth of repetitive behavior. It is a 43-item questionnaire filled by the caregivers. Each behavior assessed is rated from 0 (behavior does not occur) to 3 (behavior occurs and it is a severe problem). The total score ranks from 0 to 129. The behaviors are grouped into six domains: ritualistic behavior (range 0 to 18); sameness behavior (range 0 to 33); stereotypic behavior (range 0 to 18); self-injurious behavior (range 0 to 24); compulsive behavior (range 0 to 24); and restricted interests (range 0 to 12). A negative change represents improvement. Stratum I included patients whose FMR1 gene was fully methylated|Baseline to week 12|Full Analysis Set (FAS):all randomized patients who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline assessment for the primary efficacy parameter. Only participants who had a value at the given time and the assessment was within the window for analysis were included||Score on a scale||Standard Error|Least Squares Mean
698370|NCT01357239|Secondary|Proportion of Patients With Clinical Response, Where Response is Defined as a Reduction of at Least 25% From Baseline in the ABC-CFX Total Score and a Score of 1 (Very Much Improved) or 2 (Much Improved) on the CGI-I Scale, Stratum II|The ABC-C is a 58-item, caregiver-rated symptom checklist for assessing problem behaviors of children and adults with mental retardation at home, in residential facilities, and work training centers. The assessment was done by attributing to each item a score from 0 (“not at all a problem”) to 3 (“problem is severe in degree”) and the total score ranks from 0 to 174. The data collected from the full, 58-item ABC-C were analyzed according to ABC-CFX algorithm, for which 55 items and six subscales plus the total score were considered, and for which the total score ranks from 0 to 165. The Clinical Global Impression-Improvement (CGI-I) scale is a clinician rated scale used to assess treatment response in psychiatric patients, and the score ranges from 1 to 7 (with 1 being “very much improved”, 4 being “no change” to 7 being “very much worse”). Stratum I included patients whose FMR1 gene was fully methylated; Stratum II included patients whose FMR1 gene was partially methylated.|12 weeks|Full Analysis Set (FAS):all randomized patients who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline assessment for the primary efficacy parameter. Total is the number of patients with non-missing baseline ABC-CFX total score and at least one nonmissing post-baseline ABC-CFX total score and CGI-I assessment||Number of participants|||Number
698371|NCT01357239|Secondary|Proportion of Patients With Clinical Response, Where Response is Defined as a Reduction of at Least 25% From Baseline in the ABC-CFX Total Score and a Score of 1 (Very Much Improved) or 2 (Much Improved) on the CGI-I Scale, Stratum I|The ABC-C is a 58-item, caregiver-rated symptom checklist for assessing problem behaviors of children and adults with mental retardation at home, in residential facilities, and work training centers. The assessment was done by attributing to each item a score from 0 (“not at all a problem”) to 3 (“problem is severe in degree”) and the total score ranks from 0 to 174. The data collected from the full, 58-item ABC-C were analyzed according to ABC-CFX algorithm, for which 55 items and six subscales plus the total score were considered, and for which the total score ranks from 0 to 165. The Clinical Global Impression-Improvement (CGI-I) scale is a clinician rated scale used to assess treatment response in psychiatric patients, and the score ranges from 1 to 7 (with 1 being “very much improved”, 4 being “no change” to 7 being “very much worse”). Stratum I included patients whose FMR1 gene was fully methylated; Stratum II included patients whose FMR1 gene was partially methylated.|12 weeks|Full Analysis Set (FAS):all randomized patients who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline assessment for the primary efficacy parameter. Total is the number of patients with non-missing baseline ABC-CFX total score and at least one nonmissing post-baseline ABC-CFX total score and CGI-I assessment||Number of participants|||Number
698372|NCT01357239|Secondary|Change From Baseline in Irritability, Lethargy/Withdrawal, Stereotypic Behavior, Hyperactivity, Inappropriate Speech, and Social Avoidance Assessed by the Individual Subscales of the ABC-CFX Scale in Stratum II|"The ABC-C is a 58-item, caregiver-rated symptom checklist for assessing problem behaviors of children and adults with mental retardation at home, in residential facilities, and work training centers. The assessment was done by attributing to each item a score from 0 (not at all a problem) to 3 (problem is severe in degree) and the total score ranks from 0 to 174. The data collected from the full, 58-item ABC-C were analyzed according to the modified FXS ABC-C algorithm (ABC-CFX) for which 55 items and six subscales: irritability (range 0 to 54); lethargy/withdrawal (range 0 to 39); stereotypic behavior (range 0 to 18); hyperactivity (range 0 to 30); inappropriate speech (range 0 to 12); and social avoidance (range 0 to 12) plus the total score (range 0 to 165) were considered. A negative change represents improvement. Stratum II included patients whose FMR1 gene was partially methylated"|Baseline to week 12|Full Analysis Set (FAS):all randomized patients who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline assessment for the primary efficacy parameter. Only participants who had a value at the given time and the assessment was within the window for analysis were included||Score||Standard Error|Least Squares Mean
698404|NCT01356602|Secondary|Amount of Rescue Medication Taken (mg)|Patients used a diary to record the time of intake of rescue medication and the amount taken.|14 days|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.||milligrams (mg)||Standard Deviation|Mean
698373|NCT01357239|Secondary|Change From Baseline in Irritability, Lethargy/Withdrawal, Stereotypic Behavior, Hyperactivity, Inappropriate Speech and Social Avoidance Assessed by the Individual Subscales of the ABC-CFX Scale in Stratum I|"The ABC-C is a 58-item, caregiver-rated symptom checklist for assessing problem behaviors of children and adults with mental retardation at home, in residential facilities, and work training centers. The assessment was done by attributing to each item a score from 0 (not at all a problem) to 3 (problem is severe in degree) and the total score ranks from 0 to 174. The data collected from the full, 58-item ABC-C were analyzed according to the modified FXS ABC-C algorithm (ABC-CFX) for which 55 items and six subscales: irritability (range 0 to 54); lethargy/withdrawal (range 0 to 39); stereotypic behavior (range 0 to 18); hyperactivity (range 0 to 30); inappropriate speech (range 0 to 12); and social avoidance (range 0 to 12) plus the total score (range 0 to 165) were considered. A negative change represents improvement. Stratum I included patients whose FMR1 gene was fully methylated"|Baseline to week 12|Full Analysis Set (FAS):all randomized patients who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline assessment for the primary efficacy parameter. Only participants who had a value at the given time and the assessment was within the window for analysis were included||Score||Standard Error|Least Squares Mean
698374|NCT01357239|Secondary|Global Improvement of Symptoms in Fragile X Using the Clinical Global Impression-Improvement (CGI-I) Scale in Stratum II|The Clinical Global Impression-Improvement (CGI-I) scale is a clinician rated scale used to assess treatment response in psychiatric patients, and the score ranges from 1 to 7 (with 1 being “very much improved”, 4 being “no change” to 7 being “very much worse”). Stratum II included patients whose FMR1 gene was partially methylated|12 weeks|Full Analysis Set (FAS):all randomized patients who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline assessment for the primary efficacy parameter. Only participants who had a value at the given time and the assessment was within the window for analysis were included||Participants|||Number
698375|NCT01357239|Secondary|Global Improvement of Symptoms in Fragile X Using the Clinical Global Impression-Improvement (CGI-I) Scale in Stratum I|The Clinical Global Impression-Improvement (CGI-I) scale is a clinician rated scale used to assess treatment response in psychiatric patients, and the score ranges from 1 to 7 (with 1 being “very much improved”, 4 being “no change” to 7 being “very much worse”). Stratum I included patients whose FMR1 gene was fully methylated.|12 weeks|Full Analysis Set (FAS):all randomized patients who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline assessment for the primary efficacy parameter. Only participants who had a value at the given time and the assessment was within the window for analysis were included||Participants|||Number
698376|NCT01357239|Secondary|Global Improvement of Symptoms in Fragile X Using the Clinical Global Impression- Improvement (CGI-I) Scale in Stratum II Patients|The Clinical Global Impression-Improvement (CGI-I) scale is a clinician rated scale used to assess treatment response in psychiatric patients, and the score ranges from 1 to 7 (with 1 being “very much improved”, 4 being “no change” to 7 being “very much worse”). Stratum II included patients whose FMR1 gene was partially methylated|12 weeks|Full Analysis Set (FAS):all randomized patients who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline assessment for the primary efficacy parameter. Only participants who had a value at the given time and the assessment was within the window for analysis were included||Score||Standard Error|Least Squares Mean
698377|NCT01357239|Secondary|Global Improvement of Symptoms in Fragile X Using the Clinical Global Impression- Improvement (CGI-I) Scale in Stratum I Patients|The Clinical Global Impression-Improvement (CGI-I) scale is a clinician rated scale used to assess treatment response in psychiatric patients, and the score ranges from 1 to 7 (with 1 being “very much improved”, 4 being “no change” to 7 being “very much worse”). Stratum I included patients whose FMR1 gene was fully methylated.|12 weeks|Full Analysis Set (FAS):all randomized patients who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline assessment for the primary efficacy parameter. Only participants who had a value at the given time and the assessment was within the window for analysis were included||Score||Standard Error|Least Squares Mean
698378|NCT01357239|Secondary|Change From Baseline in Behavioral Symptoms of Fragile X Syndrome Using the ABC-CFX Total Score in Stratum I Patients Exposed to the Two Lower Doses of AFQ056 (25 mg Bid and 50 mg Bid)|The ABC-C is a 58-item, caregiver-rated symptom checklist for assessing problem behaviors of children and adults with mental retardation at home, in residential facilities, and work training centers. The assessment was done by attributing to each item a score from 0 (“not at all a problem”) to 3 (“problem is severe in degree”) and the total score ranks from 0 to 174. The data collected from the full, 58-item ABC-C were analyzed according to the modified FXS ABC-C algorithm (ABC-CFX) for which 55 items and six subscales (irritability, lethargy/withdrawal, stereotypic behavior, hyperactivity, inappropriate speech and social avoidance) plus the total score were considered, and for which the total score ranks from 0 to 165. Stratum I included patients whose FMR1 gene was fully methylated|Baseline to week 12|Full Analysis Set (FAS):all randomized patients who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline assessment for the primary efficacy parameter. Only participants who had a value at the given time and the assessment was within the window for analysis were included||Score||Standard Error|Least Squares Mean
698379|NCT01357239|Secondary|Change From Baseline in Behavioral Symptoms of Fragile X Syndrome Using the ABC-CFX Total Score in Stratum II Patients Exposed to All 3 Doses of AFQ056|The ABC-C is a 58-item, caregiver-rated symptom checklist for assessing problem behaviors of children and adults with mental retardation at home, in residential facilities, and work training centers. The assessment was done by attributing to each item a score from 0 (“not at all a problem”) to 3 (“problem is severe in degree”) and the total score ranks from 0 to 174. The data collected from the full, 58-item ABC-C were analyzed according to the modified FXS ABC-C algorithm (ABC-CFX) for which 55 items and six subscales (irritability, lethargy/withdrawal, stereotypic behavior, hyperactivity, inappropriate speech and social avoidance) plus the total score were considered, and for which the total score ranks from 0 to 165. Stratum II included patients whose FMR1 gene was partially methylated|Baseline to week 12|Full Analysis Set (FAS):all randomized patients who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline assessment for the primary efficacy parameter. Only participants who had a value at the given time and the assessment was within the window for analysis were included||Score||Standard Error|Least Squares Mean
724210|NCT00336817|Secondary|Drug Discontinuation Due to Side Effects|Drug discontinuation due to drug side effects regarding Cellcept and Myfortic.|12 weeks|||Participants|||Count of Participants
698380|NCT01357239|Primary|Change From Baseline in Behavioral Symptoms of Fragile X Syndrome Using the Aberrant Behavior Checklist–Community Edition (ABC-CFX) Total Score in Stratum I Patients Exposed to AFQ056 100 mg Bid|The Aberrant Behavior Checklist-Community edition (ABC-C) is a 58-item, caregiver-rated symptom checklist for assessing problem behaviors of children and adults with mental retardation at home, in residential facilities, and work training centers. The assessment was done by attributing to each item a score from 0 (“not at all a problem”) to 3 (“problem is severe in degree”) and the total score ranks from 0 to 174. The data collected from the full, 58-item ABC-C were analyzed according to the modified FXS ABC-C algorithm (ABC-CFX) for which 55 items and six subscales (irritability, lethargy/withdrawal, stereotypic behavior, hyperactivity, inappropriate speech and social avoidance) plus the total score were considered, and for which the total score ranks from 0 to 165. Stratum I included patients whose Fragile X Mental Retardation 1 (FMR1) gene was fully methylated|Baseline to week 12|Full Analysis Set (FAS):all randomized patients who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline assessment for the primary efficacy parameter. Only participants who had a value at the given time and the assessment was within the window for analysis were included||Score||Standard Error|Least Squares Mean
698381|NCT01357161|Secondary|Part 2: Median Overall Survival (OS) in Months|OS was defined as the time from randomization to death due to any cause, reported in months. Participants without documented death at the time of analysis were censored at the date last known to be alive. For this endpoint, all randomized participants in Part 2 were analyzed. Per protocol, Part 1 participants were not evaluated for OS.|Up to 57 months|ITT Population: All randomized participants in Part 2||months||95% Confidence Interval|Median
698382|NCT01357161|Secondary|Part 2: ORR Per GCIG Criteria Based on Both Enhanced RECIST 1.1 and CA125 Level by Independent Radiology Review|ORR defined as the percentage of participants with best response of confirmed PR or CR based both on imaging per enhanced RECIST 1.1 and on serum marker CA-125 level according to GCIC criteria. CR defined by enhanced RECIST 1.1 as disappearance of all target lesions. Any pathological lymph nodes (target or non-target) must have had reduction in short axis to <10 mm. PR was defined by enhanced RECIST 1.1 as ≥30% decrease in SOV of target lesions, taking as reference baseline SOV. Response according to CA-125 had occurred if there was ≥50% reduction in CA-125 levels from pretreatment sample. Response must have been confirmed and maintained for ≥28 days. Participants could be evaluated according to CA-125 only if they had a pretreatment sample that was ≥2 times the upper limit of normal and within 2 weeks prior to starting treatment. All randomized participants in Part 2 were analyzed. Per protocol, Part 1 participants were not included in this analysis.|Up to 57 months|ITT Population: All randomized participants in Part 2||percentage of participants||95% Confidence Interval|Number
698383|NCT01357161|Primary|Parts 1 and 2: Percentage of Participants That Discontinued Study Treatment Due to an AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR’s products, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR’s product was also an AE. The percentage of participants that discontinued study treatment (paclitaxel, carboplatin, or MK-1775) due to an AE was reported for each treatment arm.|Part 1: Day 1 through Post Study (286 days total). Part 2: Day 1 through Post Study (479 days total)|"Part 1: All participants who received at least one dose of study treatment during the open-label period.
Part 2: All randomized participants who received at least one dose of study treatment. 2 participants were randomized to the Part 2 placebo arm but were not treated."||percentage of participants|||Number
698384|NCT01357161|Primary|Parts 1 and 2: Percentage of Participants That Experienced an Adverse Event (AE)|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR’s products, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR’s product was also an AE. The percentage of participants that experienced at least one AE was reported for each treatment arm.|Part 1: Day 1 through Post Study (286 days total). Part 2: Day 1 through Post Study (479 days total)|"Part 1: All participants who received at least one dose of study treatment during the open-label period.
Part 2: All randomized participants who received at least one dose of study treatment. 2 participants were randomized to the Part 2 placebo arm but were not treated."||percentage of participants|||Number
698385|NCT01357161|Primary|Part 1: Number of Participants With a Dose Limiting Toxicity (DLT)|DLTs assessed during first 21-day cycle of Part 1 and defined as toxicities that met pre-defined severity criteria, were possibly, probably, or definitely related to triplet therapy, and could possibly result in a change in the given dose. Hematologic DLTs included Grade (Gr) 3 or Gr 4 neutropenia with fever >38.5°C and/or infection requiring antibiotic or anti-fungal treatment, and any Gr 4-5 hematological toxicity EXCEPT Gr 4 anemia, leukopenia, lymphopenia, neutropenia lasting <7 days, and thrombocytopenia lasting <4 days, except if a platelet transfusion was required. Non-hematologic DLT defined as any Gr 3, 4, or 5 nonhematologic toxicity EXCEPT: Gr 3 nausea, vomiting, diarrhea, or dehydration judged by Investigator and SPONSOR to occur in setting of inadequate compliance with supportive care measures and last for less than 48 hours, alopecia of any grade, inadequately treated hypersensitivity reactions, or clinically non-significant, treatable or reversible lab abnormalities.|During Cycle 1 of Part 1 (first 21 days)|All participants who received ≥1 dose of study treatment during Cycle 1 of Part 1 open-label period and were evaluable at the time of the interim analysis. One participant took a prohibited medication during Part 1 and was considered unevaluable. Two participants enrolled into Part 1 after the interim analysis database lock and were not included.||participants|||Number
698400|NCT01356667|Secondary|Mental Health and Psychosocial Characteristics as Measured by the Addiction Severity Index, Native American Version and Brief Symptom Inventory.|The Addiction Severity Index, Native American Version will be utilized to assess problem severity in alcohol use, drug use, employment, family and social relationships, legal, psychological, and medical status. In addition, additional information with regards to mental health characteristics will be obtained from the Brief Symptom Inventory.|Change from Baseline in Mental Health and psychosocial characteristics at 6 months|Please be advised that this clincial trial was terminated prior to finalization of any research procedures.|||||
724211|NCT00336817|Primary|Incidence of Cytomegalovirus Infection or Disease During the Study Period|number of participants|12 weeks|||participants|||Number
698386|NCT01357161|Secondary|Part 2: Median PFS in Weeks Based on RECIST 1.1 by Independent Radiology Review|PFS was defined as the time from randomization to progressive disease (based on blinded independent central radiologic review) or death, whichever occurred earlier. Tumor response was evaluated every 6 weeks during treatment by diagnostic anatomic imaging and objective response assessments were performed based on RECIST 1.1 criteria. According to RECIST 1.1, progressive disease was the appearance of one or more new lesions, OR a ≥20% increase in the sum of target lesion diameters (SOD) taking as reference the nadir (smallest SOD recorded since treatment started). PFS was analyzed for all randomized participants in Part 2 using the Kaplan-Meier method and median PFS was reported in weeks. Per protocol, Part 1 participants were not included in this analysis.|Up to 57 months|ITT Population: All randomized participants in Part 2||weeks||95% Confidence Interval|Median
698387|NCT01357161|Secondary|Part 1: Objective Response Rate (ORR) Per Gynecological Cancer Intergroup (GCIG) Criteria Based on Both RECIST 1.1 and Cancer Antigen 125 (CA-125) Level by Independent Radiology Review|ORR was defined as the percentage of participants whose best response was confirmed partial response (PR) or complete response (CR) based both on imaging per RECIST 1.1 and on serum marker CA-125 level according to GCIC criteria. CR was defined by RECIST 1.1 as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have had reduction in short axis to <10 mm. PR was defined by RECIST 1.1 as at least a 30% decrease in the sum of the diameters (SOD) of target lesions, taking as reference the baseline SOD. A response according to CA-125 had occurred if there was ≥50% reduction in CA-125 levels from a pretreatment sample. The response must have been confirmed and maintained for at least 28 days. Participants could be evaluated according to CA-125 only if they had a pretreatment sample that was ≥2 times the upper limit of normal and within 2 weeks prior to starting treatment. Only evaluable Part 1 participants were included in this analysis.|Up to 57 months|All participants receiving MK-1775 (225 mg) during Part 1 and evaluable at the time of the interim analysis. One participant took a prohibited medication during Part 1 and was considered unevaluable. Two participants enrolled into Part 1 after the interim analysis database lock and were not included.||percentage of participants||95% Confidence Interval|Number
698388|NCT01357161|Primary|Part 2: Median Progression-free Survival (PFS) in Weeks Based on Enhanced Response Evaluation Criteria In Solid Tumors Version 1.1 (Enhanced RECIST 1.1) by Independent Radiology Review|PFS was defined as the time from randomization to progressive disease (based on blinded independent central radiologic review) or death, whichever occurred earlier. Tumor response was evaluated every 6 weeks during treatment by diagnostic anatomic imaging and objective response assessments were performed based on enhanced RECIST 1.1 criteria. According to enhanced RECIST 1.1, progressive disease was the appearance of one or more new lesions, OR an unambiguous increase in the sum of target lesion volumes with both 1) >20% increase in the sum of volumes (SOV) of all target lesions (taking as reference the nadir) and 2) greater than two times the variability of the measurements estimated by the sponsor and/or its designees. PFS was analyzed for Part 2 participants only using the Kaplan-Meier method and median PFS was reported in weeks. Per protocol, Part 1 participants were not included in this analysis.|Up to 57 months|Intent to Treat (ITT) Population: All randomized participants in Part 2||weeks||95% Confidence Interval|Median
698389|NCT01357148|Primary|Number of Participants Taking Concomitant Medications||Up to approximately 28 months|||participants|||Number
698390|NCT01357148|Primary|Number of Participants With Concomitant Conditions||Up to approximately 28 months|||participants|||Number
698391|NCT01357148|Primary|Age of Participants Prescribed Sitagliptin Phosphate/Metformin HCl||Up to approximately 28 months|||years||Standard Deviation|Mean
698392|NCT01357148|Primary|Number of Participants With an Adverse Event||Up to approximately 28 months|||participants|||Number
698393|NCT01357135|Primary|Percentage of Participants With Strict Changes in Initial Dual Therapy|Strict changes in dual therapy were defined as withdrawal of an agent, replacement of one agent by another, or the addition of a third agent. Changes in dose level were not considered strict changes.|Up to 3 years|All eligible participants receiving dual therapy metformin + sitagliptin or metformin + sulfonylurea.||Percentage of Participants|||Number
698394|NCT01357135|Primary|Median Duration (in Months) of Initial Dual Therapy|The treatment maintenance duration corresponds to the treatment maintenance and persistence duration for dual therapy combining the same agents. Withdrawal of an agent, replacement of one agent by another or addition of a third agent is perceived as a change in treatment and, hence, the end of the treatment maintenance duration for dual therapy.|Up to 3 years|All eligible participants receiving dual therapy with metformin + sitagliptin or metformin + sulfonylurea.||months||95% Confidence Interval|Median
698395|NCT01356966|Secondary|Change in Heart-rate-corrected Augmentation Index (AIx)|The augmentation index (AIx) is a measure of systemic arterial stiffness, and is defined as the ratio of augmented aortic pressure (Δ P) to central pulse pressure expressed as a percent. AIx = (ΔP/PP) x 100, where P = pressure and PP = Pulse Pressure. Because heart rate (HR) affects AIx, AIx was corrected to a HR of 75 beats per minute (bpm) as follows: HR-corrected AIx = -0.39 x (75 - HR) + AIx. The mean AIx for each group was estimated as an average and expressed as a change from baseline to 12 weeks.|Baseline, 12 weeks|||percent||Standard Error|Mean
698396|NCT01356966|Secondary|Change in Mean Central Augmentation Index (AIx)|The augmentation index (AIx) is a measure of systemic arterial stiffness, and is defined as the ratio of augmentation (Δ P) to central pulse pressure and expressed as percent. AIx = (ΔP/PP) x 100, where P = pressure and PP = Pulse Pressure. The mean AIx for each group was estimated as an average and expressed as a change from baseline to 12 weeks.|Baseline, 12 weeks|||percent||Standard Error|Mean
698397|NCT01356966|Primary|Change in Resting Muscle Sympathetic Nerve Activity (MSNA)||Baseline, 12 weeks|Two subjects withdrawn from each arm due to adverse events. Additionally, two subjects from the treatment group and one subject from the placebo group were not included in this analysis because an adequate MSNA neurogram was unable to be obtained at the end of the study.||bursts/minute||Standard Error|Mean
698398|NCT01356940|Secondary|Stepcount|daily stepcount recorded by an accelerometer and averaged over 1 week of wear|10 weeks||||||
698399|NCT01356940|Primary|Peak Activity Index|peak activity index is a measure of the 30 fastest minutes of walking over a 24 hour period, averaged over one week of accelerometer wear. Measurement is change from baseline to 4 weeks on intervention|10 weeks|||change in strides per minute||Standard Deviation|Mean
699128|NCT01348139|Secondary|E0-4h: The Average of the Pulse Values Between 0 and 4 h for Every Treatment Visit|Average effect (E0-4h) of Pulse, for treatment visits 2 to 7.|0 - 4 hrs.|PD analysis set||Beats/min||Standard Deviation|Mean
698405|NCT01356602|Secondary|Time to First Rescue Medication Intake|Patients used a diary to record the time of intake of rescue medication and the amount taken.|14 days|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.||Hours||Full Range|Median
698406|NCT01356602|Secondary|Proportion of Patients With Rescue Medication Intake|Patients used a diary to record the time of intake of rescue medication and the amount taken.|12 weeks|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.||Percentage of Particpants|||Number
698407|NCT01356602|Secondary|Physician's Assessment of Range of Motion of the Most Affected Joint|The study physician assessed the patient's range of motion of the most affected joint on a 5 point Likert scale (normal, mildly restricted, moderately restricted, severely restricted and immobilized).|72 hours|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.||Percentage of Participants|||Number
698408|NCT01356602|Secondary|Physician's Assessment of Erythema|The study physician assessed the most affected joint for erythema. Erythema was assessed as present, absent or not assessable.|72 hours|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.||Percentage of Participants|||Number
698409|NCT01356602|Secondary|Physician's Assessment of Swelling|The study physician assessed the most affected joint for swelling. Swelling was measured on a 0 - 3 point scale as follows: 0 = no swelling, 1 = palpable, 2= visible and 3 = bulging beyond the joint margins.|72 hours|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.||Percentage of Partipants|||Number
698410|NCT01356602|Secondary|Physician's Assessment of Tenderness|The study physician assessed the most affected joint for tenderness. Tenderness was measured on a 0 - 3 point scale as follows: 0 = no pain, 1 = patient states that “there is pain”, 2 = patient states “there is pain and winces” and 3 = patient states “there is pain, winces and withdraws” on palpation or passive movement of the affected study joint.|72 hours|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.||Percentage of Participants|||Number
698411|NCT01356602|Secondary|Physician's Global Assessment of Response to Treatment on a 5 Point Likert Scale|A Likert scale is a type of scale with a range of responses corresponding to an item such as pain. The respondent selects the best response that indicates the respondent's subjective evaluation of the item. Study physicians scored their assessment of the patients' response to treatment on a 5-point Likert scale (very good, good, fair, poor, very poor).|72 hours|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.||Percentage of Participants|||Number
698412|NCT01356602|Secondary|Patient's Global Assessment of Response to Treatment on a 5-point Likert Scale|A Likert scale is a type of scale with a range of responses corresponding to an item such as pain. The respondent selects the best response that indicates the respondent's subjective evaluation of the item. Patients scored their response to treatment on a 5-point Likert scale (excellent, good, acceptable, slight, poor). This outcome measure shows the number of patients indicating each score on the scale.|72 hours|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.||Percentage of Participants|||Number
698413|NCT01356602|Secondary|Time to Resolution of Gouty Arthritis Flare as Reported by Patient|Patients completed diary entries at 6, 12, 24, 48 and 72 hours post dose and then daily up to 7 days post-dose and/or daily until resolution of the flare. Kaplan Meier estimate of time to resolution of gouty flare as reported by patient, along with associated 95% confiedence interval, were reported.|14 days|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.||Hours||95% Confidence Interval|Median
698414|NCT01356602|Secondary|Time to 50% Reduction in Baseline Pain on a 0 - 100 VAS|The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, patients scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. Kaplan Meier estimate of time to 50% reduction in baseline pain, along with associated 95% confidence interval, were reported.|14 days|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.||Hours||95% Confidence Interval|Median
698415|NCT01356602|Secondary|Time to the First New Gouty Arthritis Flare|Patients met the definition of a new flare if they had: a flare in a joint, which was not a previously affected joint (at baseline or during the study), or a flare in a joint previously affected (at baseline or during the study) after the previous flare in that joint had resolved completely according to the patient’s perception. Patients did NOT meet the criterion of having a new gout flare if they had increasing/renewed gout pain in an affected joint before the flare had resolved completely. Less than 50% of patients had new flares. Therefore, the median time to new flare could not be calculated.|12 weeks|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.||Days||95% Confidence Interval|Median
698416|NCT01356602|Secondary|Number of Patients With at Least One New Gouty Arthritis Flare After Baseline|Patients met the definition of a new flare if they had: a flare in a joint, which was not a previously affected joint (at baseline or during the study), or a flare in a joint previously affected (at baseline or during the study) after the previous flare in that joint had resolved completely according to the patient’s perception. Patients did NOT meet the criterion of having a new gout flare if they had increasing/renewed gout pain in an affected joint before the flare had resolved completely.|12 weeks|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.||Particpants|||Number
698417|NCT01356602|Secondary|Patient's Assessment of Pain Intensity on a 5-point Likert Scale|A Likert scale is a type of scale with a range of responses corresponding to an item such as pain. The respondent selects the best response that indicates the respondent's subjective evaluation of the item. Patients scored their pain intensity in the most affected joint of the gout flare on a 5-point Likert scale (none, mild, moderate, severe, extreme). The scores were measured to the nearest millimeter from the left. The LOCF method was used to impute post-dose pain intensity Likert measurements up to 14 days.|72 hours|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.||Percentage of Patients|||Number
698418|NCT01356602|Secondary|Patient's Assessment of Pain Intensity on a 0-100mm VAS|The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, patients scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. The LOCF method was used to impute post-dose pain intensity VAS measurements up to 14 days.|14 days|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.||Millimeters||Standard Error|Least Squares Mean
698419|NCT01356602|Secondary|Pain Intensity on a 0 - 100 mm VAS Between the Canakinumab 150 mg PFS and Canakinumab 150 mg LYO Groups|The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, patients scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. Missing pain intensity data at 72 hours was imputed using the Last-Observation-Carried-Forward (LOCF) method.|72 hours post dose|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.||Millimeters||Standard Error|Least Squares Mean
698420|NCT01356602|Primary|Pain Intensity on a 0-100 mm Visual Analog Scale (VAS) Between the Canakinumab 150 mg PFS and Triamcinolone Acetonide 40 mg Groups|The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, patients scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. Missing pain intensity data at 72 hours was imputed using the Last-Observation-Carried-Forward (LOCF) method.|72 hours post dose|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.||Millimeters||Standard Error|Least Squares Mean
698421|NCT01356589|Secondary|Percentage of Participants With Type 2 Diabetes Who Experienced at Least 1 Hemoglobin Cycling|Hemoglobin cycling was defined as 1 or more cycles of oscillation in hemoglobin with an amplitude of >=1.5 g/dL and a duration >=8 weeks.|9 months|Analysis population included all treated participants. 'N' (number of participants analyzed) included those participants who were evaluable for this outcome measure.||percentage of participants|||Number
698422|NCT01356589|Secondary|Number of Full Hemoglobin Cycles Per Participant|Hemoglobin cycling was defined as 1 or more cycles of oscillation in hemoglobin with an amplitude of >=1.5 g/dL and a duration >=8 weeks.|9 months|Analysis population included all treated participants.||cycles||Standard Deviation|Mean
698423|NCT01356589|Primary|Percentage of Participants With at Least One Hemoglobin Cycling|Hemoglobin cycling was defined as 1 or more cycles of oscillation in hemoglobin with an amplitude of greater than or equal to (>=) 1.5 gram per deciliter (g/dL) and a duration >=8 weeks.|9 months|Analysis population included all treated participants.||percentage of participants|||Number
698424|NCT01356498|Secondary|Gout Flare Incidence|Percentage of participants remaining in the study during the specified interval who experienced a gout flare during this interval.|Assessed in 3-month intervals up to 2 years|The flare incidence is reported as the percentage of participants reporting flares during each 3-month interval.||Percentage of participants|||Number
698425|NCT01356498|Secondary|Gout Flare Frequency|The the mean number of flares per subject (flare frequency)was assessed over 3-month periods for up to 2 years of treatment|Up to 2 years|Analysis is based on ITT population, and is presented by intervals of time on pegloticase||Flares||Standard Deviation|Mean
698426|NCT01356498|Secondary|Patient Reported Outcome: SF-36 Physical Component Summary Score|"SF-36 is the Medical Outcomes Survey Short Form-36, a 36-item self-reported questionnaire which assesses health-related limitations in 8 dimensions. The Physical Component Summary Score (PCS) is a composite summary score derived from the dimensions related to physical functioning outcomes: Physical Function, Role Physical, General Health and Bodily Pain (each with a 0 to 100 scale where 0=worst, 100=best).
The Summary Score is constructed as a T-score with a mean of 50 and standard deviation of 10, where higher scores indicate a better health status."|RCT Week 25; OLE Week 25; OLE Week 53, OLE Week 77, OLE Week 101|Number of participants was the subset of the ITT population with SF-36 baseline data||units on a scale||Standard Deviation|Mean
698427|NCT01356498|Secondary|Tophus Response|Target tophi evaluated during the randomized, controlled study were followed for response at 3, 6, 12, 18 and 24 months in this open-label extention study. Results from each participant's final assessment on drug are reported (as last observation carried forward). Complete response=complete disappearance of at least one tophus with no new or worsening tophus. Partial Response=a 50% or more decrease in at least one tophus with no new or worsening tophus.|Up to 2 years|ITT, Last observation(on drug) carried forward showing patients with an Overall Tophus Response of Complete or Partial Response.||participants|||Number
698428|NCT01356498|Primary|Uric Acid (mg/dL)|Uric acid measured at 3 month-intervals|Week 13, Week 25, Week 53, Week 101|ITT||mg/dL||Standard Deviation|Mean
698429|NCT01356407|Secondary|Proportion of Subjects Requiring a Repeat Colonoscopy Due to Poor Bowel Preparation|The Proportion of subjects requiring a repeat colonoscopy due to poor bowel preparation|Day 2|Full Analysis Set (FAS) All randomised patients who have received at least one dose of the study drug and have evaluable data from the Ottawa Bowel Preparation Scale (OBPS) will form the Full Analysis Set.||participants|||Number
698430|NCT01356407|Secondary|Proportion of Successful Colonoscopies in the Clinical Setting (Predicted by Ottawa Scale Score)|At colonoscopy, bowel preparations were rated by the treatment-blinded endoscopist, as being of an overall quality “adequate for clinical diagnostic purposes” (Y/N). The total Ottawa Scale scores was correlated with ‘adequate’ or ‘inadequate’ quality of bowel preparation for clinical diagnostic purposes|Day 2|Full Analysis Set (FAS) All randomised patients who have received at least one dose of the study drug and have evaluable data from the Ottawa Bowel Preparation Scale (OBPS) will form the Full Analysis Set.||units on a scale||Standard Deviation|Mean
698431|NCT01356407|Secondary|Percentage of Successful Completion of Colonoscopy|An overview of completion rates of colonoscopy (i.e., endoscope reaching the ileocecal valve)|Day 2|Full Analysis Set (FAS) All randomised patients who have received at least one dose of the study drug and have evaluable data from the Ottawa Bowel Preparation Scale (OBPS) will form the Full Analysis Set.||Percentage of Subjects (%)|||Number
698432|NCT01356407|Secondary|Ottawa Scale Score by Colon Segment|Mean Ottawa Scale scores, and score categories (from 'excellent’ to ‘bad’), are summarised by colon segment together with the overall fluid content score|Day 2|All randomized patients who have received at least one dose of the study drug and have evaluable data from the Ottawa Bowel Preparation Scale (OBPS) will form the Full Analysis Set.||units on a scale||Standard Deviation|Mean
698433|NCT01356407|Secondary|Patient Response to Acceptability and Tolerability Questionnaire|On the day of the procedure, but before colonoscopy or any sedation for colonoscopy, subjects were asked to complete a standardised questionnaire regarding whether or not complete the IMP (yes or no), ease of taking IMP (rating from 1 point(very easy) to 5 point (very difficult)), degree of acceptability to study med (rating from 1 point (excellent) to 5 point (bad)), palatability of IMP (rating from 1 point (excellent) to 5 point (bad)) and tolerability (5 adverse reactions including abdominal bloating, spasms, nausea, vomiting and general malaise which were generally reported in bowel preparation with rating according to intensity from 1 point (None) to 4 point (Severe)).|Day 2|Full Analysis Set (FAS) All randomised patients who have received at least one dose of the study drug and have evaluable data from the Ottawa Bowel Preparation Scale (OBPS) will form the Full Analysis Set||units on a scale||Standard Deviation|Mean
698434|NCT01356407|Primary|The Ottawa Scale Score of Patients Who Had Successfully Completed the Colonoscopy Examination After Having Completed the Study Bowel Preparation|The total Ottawa Bowel Preparation Scale (OBPS) score, rated by the treatment-blinded Investigator at colonoscopy, was designed to evaluate cleanliness of the colon by grading the endoscopic visibility of the mucosa according to a scale from 0 (‘excellent’ visibility) to 4 (‘inadequate’ visibility); The component scores for each of the colon segment are added together, along with an overall ‘fluid’ score (from small amount = 0, to large amount = 2). Thus, the total OBPS has a range from 0 (a perfect preparation) to 14 (a completely unprepared bowel)|day 2|Full Analysis Set (FAS) All randomised patients who have received at least one dose of the study drug and have evaluable data from the Ottawa Bowel Preparation Scale (OBPS) will form the Full Analysis Set.||units on a scale||Standard Deviation|Mean
698435|NCT01356147|Secondary|Number of Days on Ventilator Support||7 days||||||
698436|NCT01356147|Secondary|Reduction in White Blood Cell Count and Bacterial Load From Tracheal Aspirate||During first week of treatment or until extubation whichever is earlier||||||
698437|NCT01356147|Primary|Percent Reduction in Oxygen Requirement From Baseline|Change in required supplemental oxygen from baseline or time to extubation from mechanical ventilation|First week of treatment or extubation|||percentage FiO2||Full Range|Mean
698438|NCT01355978|Secondary|Safety and Device-related Adverse Events|Any adverse events reported during he study period.|Continuous from Study Day 2 through Study Day 6|||participants|||Number
698439|NCT01355978|Secondary|Device Preference|"5-point Likert Scale completed at the end or the 5-day study period
- Preference Scale: 5 = Max preference (Prefer to use the test device), 1 = Min preference (Do not prefer to use the test device)"|At conclusion of subject's participation (up to two weeks)|||units on a scale||Full Range|Median
698440|NCT01355978|Primary|Device Tidal Volume|Evaluate the mean test volume for three activity levels. Subjects completed five consecutive, 6-hour clinic days in which the NIOV system was worn continuously while at rest, during activities of daily living (ADLs).|Periodically over six hours x 5 days|||mL||Standard Deviation|Mean
698441|NCT01355705|Secondary|Time-to-next Treatment||9 months|||days||Full Range|Median
698442|NCT01355705|Secondary|Progression-free Survival (PFS)|"Progression-free survival (PFS) is alive and free from progression, per the modified International Myeloma Working Group Uniform Response Criteria, defined as any of:
Serum monoclonal protein ≥ 125% baseline and/or ≥ +0.5 g/dL from baseline,
Urine monoclonal protein ≥ 125% baseline and/or ≥ +200 mg/24 hour from baseline
New or increased bone lesions or plasmacytomas
Serum calcium > 11.5 mg/dL (attributed to increased plasma cells)"|9 months|||days||Full Range|Median
698443|NCT01355705|Secondary|Duration of Response (DOR)||140 days|||days||Full Range|Median
698487|NCT01355224|Primary|Intention to Lose Weight - Combined Risk|Intention to lose 10lbs in the next 6 months on a 5-point likert scale (1-strongly disagree; 5-strongly agree). This was examined by study arm and by combined levels of feedback (e.g. elevated genetic risk and non-elevated lifestyle risk)|3 months from viewing obesity risk assessment|||units on a scale||95% Confidence Interval|Mean
698444|NCT01355705|Primary|Response Rates After Amrubicin + Lenalidomide + Dexamethasone, Per International Myeloma Working Group Uniform Response Criteria|"Modified International Myeloma Working Group Uniform Response Criteria:
Complete (CR)=
Negative for monoclonal protein (MP) in urine (U) and serum (S) +
No tissue plasmacytomas (PC) +
<5% plasma cells (PCs) in marrow (M)
Stringent CR (sCR)= CR with normal light chain ratio+ no PCs in M
Near CR (nCR)= CR, except MP persists in U and S
Partial (PR)= S MP ≤50%, + U MP ≤90% or <200 mg/24 hours (hr)
Very Good PR (VGPR)= in S MP ≤90%, + U MP <100 mg/24 hr
Minimal (MR)=
S MP ≤51-75%, +
If light chain is excreted, reduced 50-89%/24 hr that is also >200 mg/24 hr, +
No increase in lytic bone lesions
Progressive disease (PD)= any of:
S MP ≥125% and/or ≥+0.5 g/dL,
U MP ≥125% and/or ≥+200 mg/24 hr
New or increased bone lesions/PC
S calcium >11.5 mg/dL (attributed to increased PCs)
PD after CR/sCR=
Reappearance of S or U MP
≥5% clonal PCs in M
New PC, lytic bone lesions, hypercalcemia
Stable Disease (SD)= Not CR, VGPR, MR, PR, or PD"|12 weeks|||percentage of participants|||Number
698445|NCT01355679|Secondary|Activity of Treatments Chosen Based on Progression Free Survival (PFS)|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|1 year|||Days||95% Confidence Interval|Mean
698446|NCT01355679|Secondary|Overall Response Rate (ORR) of Participants Using RECIST Criteria|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|1 year|||percentage of participants with PR or CR|||Number
698447|NCT01355679|Secondary|Number of Participants With Adverse Events as a Measure of Safety|To determine the safety of allowing a molecular tumor board to determine individualized treatment plans|1 year|||participants|||Number
698448|NCT01355679|Primary|Percentage of Participants That Are Able to Meet Feasibility Parameters.|Feasibility parameter defined as: Enrollment onto study, quality mRNA obtained, gene chip completed, tumor board held, medical monitor review and approval, start of treatment by 21 days post biopsy/surgical resection date, and then completion of 1 cycle of therapy.”|1 year|All subjects had soft tissue disease in which biopsy was possible. Two subjects were deemed ineligible due to benign tumor type after biopsy.||percentage of participants|||Number
698449|NCT01355627|Secondary|Percentage of Participants With Post-Surgical Non-Clinically Evident Post-Operative Pseudomeningocele|Non-clinically evident pseudomeningocele was defined as a cerebrospinal fluid accumulation found on a postoperative computerized tomography (CT) or magnetic resonance imaging (MRI) scan which fulfilled the following criteria according to the radiologist assessment before Day of Discharge: CT Scan-Fluid accumulation seen as Hypodense signal, MRI Scan-Fluid accumulation seen as Hypointense signal in T1-weighted image and/ OR Fluid accumulation seen as Hyperintense signal in T2-weighted image.|Assessment at least once prior to discharge from neurosurgical ward, with the expected discharge from neurosurgical ward after an average of 10 days (Up to 28 Weeks)|Full Analysis Population included all enrolled randomized patients.||percentage of participants||95% Confidence Interval|Number
698450|NCT01355627|Primary|Percentage of Participants With Clinically Evident Verified Post-Operative Cerebrospinal Fluid Leak or Clinically Evident Pseudomeningocele or Treatment Failure|An assessment was performed daily from randomization to Day of Discharge and at the Efficacy Follow-up visit at week 7 ± 1 week. Clinically evident cerebrospinal fluid leak was confirmed by: 1. Glucose concentration test and/or 2. β-2-transferrin test. A clinically evident pseudomeningocele was considered to be present post-operatively if the following criteria were fulfilled: 1. A subcutaneous, visible/palpable fluctuant fluid accumulation was noted at the site of the surgical incision or adjacent to it; 2. It is suspected the fluid accumulation is cerebrospinal fluid. A treatment failure was defined as application of a new and/or different treatment after application of the study treatment or a third application of (or part of) the selected study treatment on the outside of the dura.|Up to 8 Weeks (7 Weeks ± 1 Week)|Full Analysis Population included all enrolled randomized patients.||percentage of participants||95% Confidence Interval|Number
698451|NCT01355588|Secondary|Time to Reach Maximum Plasma Concentration (Tmax)||Anytime at pre-dose, 15 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours (ketorolac tromethamine only), and 24 hours (ketorolac tromethamine only) post-dose|||hours||Full Range|Median
698452|NCT01355588|Primary|Area Under the Plasma Concentration-time Profile From Time Zero to Infinity (AUC 0-∞)||Anytime at pre-dose, 15 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours (ketorolac tromethamine only), and 24 hours (ketorolac tromethamine only) post-dose|||ng*h/mL||Standard Deviation|Mean
698453|NCT01355588|Primary|Area Under the Plasma Concentration-time Profile From Time Zero to the Last Quantifiable Post-dose (AUC 0-t)||Anytime at pre-dose, 15 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours (ketorolac tromethamine only), and 24 hours (ketorolac tromethamine only) post-dose|||ng*h/mL||Standard Deviation|Mean
698454|NCT01355588|Primary|Maximum Observed Plasma Concentration (Cmax)||Anytime at pre-dose, 15 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours (ketorolac tromethamine only), and 24 hours (ketorolac tromethamine only) post-dose|||ng/mL||Standard Deviation|Mean
698455|NCT01355523|Secondary|Incidence of Postoperative Cognitive Dysfunction (POCD) App. 10 Weeks Postoperatively|"Calculations for POCD were based on normative data from 133 females aged 40-60 years. We evaluated changes from the preoperative baseline to the 2 postoperative test sessions. In controls we calculated mean and standard deviations (SD) of these differences. The mean change in this group may be taken as estimated learning effects. For the individual patients, we compared baseline scores with the 2- and 12-week postoperative test results, subtracted the average learning effect from the changes and divided the result by the SD of the control group to obtain a Z score for the 7 individual test outcomes. A large positive Z score indicated deterioration in cognitive function from baseline in patients. We defined a composite Z score as the sum of the 7 Z scores and normalized this using the SD for that sum in the controls. POCD was defined as a combined Z score >1.96 or a Z score >1.96 in at least 2 of the 7 subtests.
Units of measure = % of patients with YES to POCD"|App. 10 weeks postoperatively|Analysis includes only patients who completed all parts of the neuropsychological test battery at baseline and 10 weeks postoperatively.||Percentage of patients|||Number
698456|NCT01355523|Secondary|Incidence of Postoperative Cognitive Dysfunction (POCD) App. 2 Weeks Postoperatively.|"Calculations for POCD were based on normative data from 133 females aged 40-60 years. We evaluated changes from the preoperative baseline to the 2 postoperative test sessions. In controls we calculated mean and standard deviations (SD) of these differences. The mean change in this group may be taken as estimated learning effects. For the individual patients, we compared baseline scores with the 2- and 12-week postoperative test results, subtracted the average learning effect from the changes and divided the result by the SD of the control group to obtain a Z score for the 7 individual test outcomes. A large positive Z score indicated deterioration in cognitive function from baseline in patients. We defined a composite Z score as the sum of the 7 Z scores and normalized this using the SD for that sum in the controls. POCD was defined as a combined Z score >1.96 or a Z score >1.96 in at least 2 of the 7 subtests.
Units of measure = % of patients with YES to POCD"|App. 2 weeks postoperatively|Analysis includes only patients who completed all parts of the neuropsychological test battery at baseline and 2 weeks postoperatively.||Percentage of patients|||Number
698457|NCT01355523|Secondary|HPER3 Genotype|A blood sample will be taken at inclusion and analysed for HPER3 genotype (4/4, 4/5, 5/5) and this will be investigated for a correlation with sleep, cognitive function and depressive symptoms 7 patients did not give blood samples|At inclusion = day-7|||Participants|||Number
698458|NCT01355523|Secondary|Sleep Architecture|Actigraphy (total minutes asleep, sleep effectiveness, sleep latency, awakenings). A wrist actigraph will be worn from inclusion till 14 days postoperatively.|From inclusion till 14 days postoperatively||||||
698459|NCT01355523|Secondary|Area Under the Curve (AUC) for VAS Data on Sleep Quality - Long-term Postoperative Period|"Subjective sleep on a Visual Analog Scale. Subjective sleep quality was registered on a VAS going from best possible sleep, equivalent to 0mm to worst possible sleep, equivalent to 100mm.
Patients were only included in the analysis if they had completed VAS on anxiety, sleep quality, general well-being, fatigue, pain and sleepiness in the long-term postoperative period (every 14th day).
Single missing data were filled out using last observation carried forward (LOCF). % of cases filled out by LOCF < 1 %"|App. 14 days postoperatively till 10 weeks postoperatively|||mm*2 weeks||Inter-Quartile Range|Median
698460|NCT01355523|Secondary|Area Under the Curve (AUC) for VAS Data on Sleep Quality - Immediate Postoperative Period|"Subjective sleep score on Visual Analog Scale. Subjective sleep quality was registered on a VAS going from best possible sleep, equivalent to 0mm to worst possible sleep, equivalent to 100mm.
Patients were only included in the analysis if they had completed daily VAS on anxiety, sleep quality, general well-being, fatigue, pain and sleepiness for at least 8 days postoperatively.
Single missing data were filled out using last observation carried forward (LOCF). % of cases filled out by LOCF < 2 %"|Daily from inclusion till 8 days postoperatively|||mm*day||Inter-Quartile Range|Median
698461|NCT01355523|Secondary|Area Under the Curve (AUC) for VAS Data on Pain - Long-term Postoperative Period|"Pain on a Visual Analog Scale - filled out every 14th day. A subjective feeling of pain was registered on a VAS going from no pain, equivalent to 0mm to worst possible pain, equivalent to 100mm.
Patients were only included in the analysis if they had completed VAS on anxiety, sleep quality, general well-being, fatigue, pain and sleepiness in the long-term postoperative period (every 14th day).
Single missing data were filled out using last observation carried forward (LOCF). % of cases filled out by LOCF < 1 %"|App. 14 days postoperatively till 10 weeks postoperatively|||mm*2 weeks||Inter-Quartile Range|Median
698462|NCT01355523|Secondary|Area Under the Curve (AUC) for VAS Data on Pain - Immediate Postoperative Period|"Pain on a Visual Analog Scale - filled out daily. A subjective feeling of pain was registered on a VAS going from no pain, equivalent to 0mm to worst possible pain, equivalent to 100mm.
Patients were only included in the analysis if they had completed daily VAS on anxiety, sleep quality, general well-being, fatigue, pain and sleepiness for at least 8 days postoperatively.
Single missing data were filled out using last observation carried forward (LOCF). % of cases filled out by LOCF < 2 %"|Daily from inclusion till 8 days postoperatively|||mm*day||Inter-Quartile Range|Median
698463|NCT01355523|Secondary|Area Under the Curve (AUC) for VAS Data on General Well-being - Long-term Postoperative Period|"General well-being on a Visual Analog Scale - filled out every 14th day. A subjective feeling of general well-being was registered on a VAS going from very high well-being, equivalent to 0mm to very low well-being, equivalent to 100mm.
Patients were only included in the analysis if they had completed VAS on anxiety, sleep quality, general well-being, fatigue, pain and sleepiness in the long-term postoperative period (every 14th day).
Single missing data were filled out using last observation carried forward (LOCF). % of cases filled out by LOCF < 1 %"|App. 14 days postoperatively till 10 weeks postoperatively|||mm*2 weeks||Inter-Quartile Range|Median
698464|NCT01355523|Secondary|Area Under the Curve (AUC) for Data on General Well-being - Immediate Postoperative Period|"General well-being on a Visual Analog Scale - filled out daily. A subjective feeling of general well-being was registered on a VAS going from very high well-being, equivalent to 0mm to very low well-being, equivalent to 100mm.
Patients were only included in the analysis if they had completed daily VAS on anxiety, sleep quality, general well-being, fatigue, pain and sleepiness for at least 8 days postoperatively.
Single missing data were filled out using last observation carried forward (LOCF). % of cases filled out by LOCF < 2 %"|Daily from inclusion till 8 days postoperatively|Patients were only included in the analysis if they had completed daily VAS on anxiety for at least 8 days postoperatively. Single missing data were filled out using last observation carried forward.||mm*day||Inter-Quartile Range|Median
698465|NCT01355523|Secondary|Area Under the Curve (AUC) for VAS Data on Fatigue - Long-term Postoperative Period|"Fatigue on a Visual Analog Scale - filled out every 14th day. A subjective feeling of fatigue was registered on a VAS going from no fatigue, equivalent to 0mm to worst possible fatigue, equivalent to 100mm.
Patients were only included in the analysis if they had completed VAS on anxiety, sleep quality, general well-being, fatigue, pain and sleepiness in the long-term postoperative period (every 14th day).
Single missing data were filled out using last observation carried forward (LOCF). % of cases filled out by LOCF < 1 %"|App. 14 days postoperatively till 10 weeks postoperatively|||mm*2 weeks||Inter-Quartile Range|Median
698488|NCT01355224|Primary|Intention to Lose Weight - Impact of Risk Status|Intention to lose 10lbs in the next 6 months measured on a 5-point likert scale (1-strongly disagree;5-strongly agree). This was examined by study arm and level of feedback received (high or elevated risk vs low or non-elevated risk).|3 months after viewing obesity risk assessment|||units on a scale||95% Confidence Interval|Mean
698466|NCT01355523|Secondary|Area Under the Curve (AUC) for VAS Data on Fatigue - Immediate Postoperative Period|"Fatigue on a Visual Analog Scale - filled out daily. A subjective feeling of fatigue was registered on a VAS going from no fatigue, equivalent to 0mm to worst possible fatigue, equivalent to 100mm.
Patients were only included in the analysis if they had completed daily VAS on anxiety, sleep quality, general well-being, fatigue, pain and sleepiness for at least 8 days postoperatively.
Single missing data were filled out using last observation carried forward (LOCF). % of cases filled out by LOCF < 2 %"|Daily from inclusion till 8 days postoperatively|||mm*day||Inter-Quartile Range|Median
698467|NCT01355523|Secondary|Area Under the Curve (AUC) for Data on Sleepiness (KSS) - Long-term Postoperative Period|"Sleepiness measured by Karolinska Sleepiness Scale. KSS is a 9-point scale from 1 (very awake) to 9 (very sleepy) where a score of 7 or more reflects pathological sleepiness.
Patients were only included in the analysis if they had completed VAS on anxiety, sleep quality, general well-being, fatigue, pain and sleepiness in the long-term postoperative period (every 14th day).
Single missing data were filled out using last observation carried forward (LOCF). % of cases filled out by LOCF < 1 %"|App. 14 days postoperatively till 10 weeks postoperatively|||Units on KSS*2 weeks||Inter-Quartile Range|Median
698468|NCT01355523|Secondary|Area Under the Curve (AUC) for Data on Sleepiness (KSS) - Immediate Postoperative Period|"Sleepiness measured by Karolinska Sleepiness Scale. KSS is a 9-point scale from 1 (very awake) to 9 (very sleepy) where a score of 7 or more reflects pathological sleepiness.
Patients were only included in the analysis if they had completed daily VAS on anxiety, sleep quality, general well-being, fatigue, pain and sleepiness for at least 8 days postoperatively.
Single missing data were filled out using last observation carried forward (LOCF). % of cases filled out by LOCF < 2 %"|Daily from inclusion till 8 days postoperatively|||Units on KSS*day||Inter-Quartile Range|Median
698469|NCT01355523|Secondary|Area Under the Curve (AUC) for VAS Data on Anxiety - Long-term Postoperative Period|"Anxiety measured by VAS (visual analog scale). Completed every 14th day. A subjective feeling of anxiety was registered on a VAS going from no anxiety, equivalent to 0mm to worst possible anxiety, equivalent to 100mm.
Patients were only included in the analysis if they had completed VAS on anxiety, sleep quality, general well-being, fatigue, pain and sleepiness in the long-term postoperative period (every 14th day).
Single missing data were filled out using last observation carried forward (LOCF). % of cases filled out by LOCF < 1 %"|App. 14 days postoperatively till 10 weeks postoperatively|Patients were only included in the analysis if they had completed VAS on anxiety in the long-term postoperative period. Single missing data were filled out using last observation carried forward.||mm*2 weeks||Inter-Quartile Range|Median
698470|NCT01355523|Secondary|Area Under the Curve (AUC) for VAS Data on Anxiety - Immediate Postoperative Period|"Anxiety measured by VAS (visual analog scale). A subjective feeling of anxiety was registered on a VAS going from no anxiety, equivalent to 0mm to worst possible anxiety, equivalent to 100mm.
Patients were only included in the analysis if they had completed daily VAS on anxiety, sleep quality, general well-being, fatigue, pain and sleepiness for at least 8 days postoperatively.
Single missing data were filled out using last observation carried forward (LOCF). % of cases filled out by LOCF < 2 %"|Daily - from inclusion till 8 days postoperatively|||mm*day||Inter-Quartile Range|Median
698471|NCT01355523|Primary|Intention to Treat (Overestimate) - Depression at One Point in the Study Period|"MDI is a self-rating depression scale with 12 questions. MDI has previously been investigated in a Danish population. On a six-point Likert scale, the items measure how much time the symptoms have been present during the last 14 days. MDI is scored according to specific guidelines and can be used either as a rating scale or diagnostic instrument.
For inclusion we used the diagnostic instrument (depression was an exclusion criteria) and for all other MDI measurements we used the rating scale.
Rating scale:
No depression - score from 0-20 Mild depression - score from 21-25 Moderate depression - score from 26-30 Severe depression - score from 31-50 For this analysis all missing MDI data have been analyzed as “YES” for depression."|Intention to treat (overestimate) - depression at one point in the study period (not baseline)|"All missing data have been analyzed as YES depression."||participants|||Number
698472|NCT01355523|Primary|Intention to Treat (Underestimate) - Depression at One Point in the Study Period|"MDI is a self-rating depression scale with 12 questions. MDI has previously been investigated in a Danish population. On a six-point Likert scale, the items measure how much time the symptoms have been present during the last 14 days. MDI is scored according to specific guidelines and can be used either as a rating scale or diagnostic instrument.
For inclusion we used the diagnostic instrument (depression was an exclusion criteria) and for all other MDI measurements we used the rating scale.
Rating scale:
No depression - score from 0-20 Mild depression - score from 21-25 Moderate depression - score from 26-30 Severe depression - score from 31-50 For this analysis all missing MDI data have been analyzed as “NO” depression."|Intention to treat (underestimate) - depression at one point in the study period (not baseline)|"All missing MDI data have been analyzed as NO depression."||participants|||Number
698473|NCT01355523|Primary|Per Protocol - Depression at One Point in the Study Period|"MDI is a self-rating depression scale with 12 questions. MDI has previously been investigated in a Danish population. On a six-point Likert scale, the items measure how much time the symptoms have been present during the last 14 days. MDI is scored according to specific guidelines and can be used either as a rating scale or diagnostic instrument.
For inclusion we used the diagnostic instrument (depression was an exclusion criteria) and for all other MDI measurements we used the rating scale.
Rating scale:
No depression - score from 0-20 Mild depression - score from 21-25 Moderate depression - score from 26-30 Severe depression - score from 31-50 This analysis includes only patients who have taken study medication as planned."|Per protocol - depression at one point in the study period (not baseline)|Includes only patients who have taken the study medication as planned||participants|||Number
698489|NCT01355224|Primary|Intentions to Lose Weight - Effect of Study Arm on Outcomes|Intention to lose 10lbs in the next 6 months was measured on a 5-point likert scale (1-strongly disagree;5-strongly agree). Responses were examined by study arm.|3 months after viewing obesity risk assessment|||units on a scale||95% Confidence Interval|Mean
698515|NCT01354652|Secondary|Incidence of Elevated Venous Lactate Levels More Than 2 mmol/L Directly Related to NRTI|incidence of elevated venous lactate levels more than 2 mmol/L directly related to NRTI until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.|Participants will be followed for the duration of hospital stay, an expected average of 8 weeks||||||
698474|NCT01355523|Primary|Major Depression Inventory (MDI)- Depression at One Point in the Study|"MDI is a self-rating depression scale with 12 questions. MDI has previously been investigated in a Danish population. On a six-point Likert scale, the items measure how much time the symptoms have been present during the last 14 days. MDI is scored according to specific guidelines and can be used either as a rating scale or diagnostic instrument.
For inclusion we used the diagnostic instrument (depression was an exclusion criteria) and for all other MDI measurements we used the rating scale.
Diagnostic scale using the ICD-10 algorithm:
Mild depression: 2 core symptoms and 2 other symptoms Moderate depression: 2 core symptoms and 4 other symptoms Severe depression: 3 core symptoms and 5 other symptoms
Rating scale:
No depression - score from 0-20 Mild depression - score from 21-25 Moderate depression - score from 26-30 Severe depression - score from 31-50"|Depression at one point in the study (not including baseline) out of 4 measurements at app. day 21, day 35, day 63 and day 91 of the study.|Includes all patients who have completed at least one other MDI than baseline||participants|||Number
698475|NCT01355484|Primary|Lean Body Mass|Measure is the percentage of subjects at day 84 with lean body mass change >=0% from their baseline value.|Day 84|Subjects included in the Full Analysis Set||percentage of subjects||95% Confidence Interval|Number
698476|NCT01355484|Primary|Physical Function|Measure is the percentage of subjects at day 84 with stair climb power change >=10% from their baseline value.|Day 84|Subjects included in the Full Analysis Set||percentage of subjects||95% Confidence Interval|Number
698477|NCT01355471|Primary|Composite Success|Composite Success is defined as 2-grade improvement on both Clinician Erythema Assessment (CEA) and Patient Self Assessment(PSA).|Day 29|Intent-to-Treat (ITT) population(i.e. Hours 3,6,9,12)||participants|||Number
698478|NCT01355458|Primary|Composite Success|Composite Success is defined as 2-grade improvement on both Clinician Erythema Assessment (CEA) and Patient Self Assessment(PSA).|Day 29|Intent-to-Treat (ITT) population (i.e. Hours 3,6,9,12)||participants|||Number
698479|NCT01355419|Secondary|Change in Physical Activity (Number of Steps/Day)Before and After CPAP Therapy in OSA Patients|Change in Physical activity (number of steps/day)before and after CPAP therapy in OSA patientsevaluated by actigraphy|baseline and at 3 months|||steps||Standard Deviation|Mean
698480|NCT01355419|Primary|Change in Total Sleep Time Before and After CPAP Therapy in Obstructive Sleep Apnea Patients|change in Total sleep time before and after CPAP therapy in obstructive sleep apnea patients, assessed by actigraphy|baseline and at 3 months|||minutes||Standard Deviation|Mean
698481|NCT01355302|Secondary|Time to Progression (TTP)|The study was terminated prior to enrollment in Phase 2 so this outcome measure was not conducted.|Until disease progression or death for 3 years|The study was terminated prior to enrollment in Phase 2 so this outcome measure was not conducted.|||||
698482|NCT01355302|Secondary|Overall Response Rate (ORR)|The study was terminated prior to enrollment in Phase 2 so this outcome measure was not conducted.|Until disease progression or death for 3 years|The study was terminated prior to enrollment in Phase 2 so this outcome measure was not conducted.|||||
698483|NCT01355302|Primary|Time to Maximum Concentration (Tmax) of Golvatinib|Tmax was defined as the time at which Cmax was observed for golvatinib in combination with cisplatin and capecitabine.|Cycle 1 (Day -2); predose, 30 minutes, 1, 2, 3, 4, 8, 12 (if feasible), 24, and 48 hours after study treatment. Cycle 2 (Day 1); predose, 30 minutes, 1, 2, 3, 4, 8, 12 (if feasible), and 24 hours after study treatment.|Pharmacokinetic (PK) population: All participants in the Safety Population who had sufficient concentration data to derive one or more of the PK parameters. Participants with partial data were evaluated on a case-by-case basis to determine if sufficient data were available for meaningful PK analysis.||Hours||Full Range|Median
698484|NCT01355302|Primary|Number of Participants With a Treatment-Emergent Adverse Event (TEAE)|Safety assessments consisted of monitoring and recording all adverse events (AEs) and serious AEs; regular monitoring of hematology, blood chemistry, and urine values; periodic measurement of vital signs and electrocardiograms (ECGs); and performance of physical examinations. A TEAE was defined as an adverse event (AE) that had an onset date, or a worsening in severity from Baseline (pretreatment), on or after the first dose of study drug up to 30 days after the date of last study treatment.|From date of first dose up to 30 days after the last dose of study treatment, up to approximately 1 year 1 month.|Safety Population included all participants who received at least one dose of study drug and who had at least one safety assessment after the first dose of study drug.||Participants|||Number
698485|NCT01355302|Primary|Maximum Concentration (Cmax) of Golvatinib|Blood samples were drawn to analyze the amount of golvatinib in the participant's serum. Maximum concentration refers to the maximum (or peak) serum concentration of study drug in the participant's system after administration of the study drug and prior to the administration of a second dose of the study drug. Results were expressed in nanograms/milliliter (ng/mL).|Cycle 1 (Day -2); predose, 30 minutes, 1, 2, 3, 4, 8, 12 (if feasible), 24, and 48 hours after study treatment. Cycle 2 (Day 1); predose, 30 minutes, 1, 2, 3, 4, 8, 12 (if feasible), and 24 hours after study treatment.|Pharmacokinetic (PK) population: All participants in the Safety Population who had sufficient concentration data to derive one or more of the PK parameters. Participants with partial data were evaluated on a case-by-case basis to determine if sufficient data were available for meaningful PK analysis.||ng/mL||Full Range|Median
698486|NCT01355302|Primary|Area Under The Concentration-Time Curve (AUC) From 0 to 24 Hours of Golvatinib|On days when pharmacokinetic (PK) samples were to be drawn, a predose blood sample was obtained prior to administration of golvatinib and capecitabine. After administration of study drugs, a second postdose blood sample was taken. The amount of golvatinib in the participant's blood was analyzed and the AUC was calculated. The AUC reflects the actual body exposure to drug after administration of a dose of the drug and is dependent on the rate of elimination of the drug from the body and the dose administered. Predose samples that were below the limit of quantitation (BLQ) or missing were assigned a numerical value of zero for the calculation of AUC. Any other BLQ concentrations were assigned a value of zero. Results were expressed in nanograms·hour/milliter (ng·h/mL).|Cycle 1 (Day -2); predose, 30 minutes, 1, 2, 3, 4, 8, 12 (if feasible), 24, and 48 hours after study treatment. Cycle 2 (Day 1); predose, 30 minutes, 1, 2, 3, 4, 8, 12 (if feasible), and 24 hours after study treatment.|Pharmacokinetic (PK) population: All participants in the Safety Population who had sufficient concentration data to derive one or more of the PK parameters. Participants with partial data were evaluated on a case-by-case basis to determine if sufficient data were available for meaningful PK analysis.||ng·h/mL||Full Range|Median
698490|NCT01355081|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score After 8 Weeks of Treatment|The SDS is a 3 item rating scale to assess functional impairment (panic, anxiety, phobic and depressive symptoms) over three inter-related domains (work/school, social life, and family life/home responsibilities) rated on an 11 point scale from 0 (not at all) to 10 (extremely) with a total score range from 0 to 30. Higher scores indicate greater severity of impairment. A negative change from Baseline indicates that symptoms have improved. ANCOVA model was used with treatment as a fixed effect and the Baseline SDS total score as a covariate.|Baseline, Week 8|Participants from the Full Analysis Set (FAS), defined as all participants who were randomized and received at least 1 dose of study drug, who had data available for this outcome measure. One participant in the Vortioxetine 10 mg group was excluded due to a major protocol deviation. Last Observation Carried Forward (LOCF).||scores on a scale||Standard Error|Least Squares Mean
698491|NCT01355081|Secondary|Clinical Global Impression Scale-Improvement (CGI-I) Score After 8 Weeks of Treatment|"The CGI-I assesses the clinician's impression of the participant's state of mental illness improvement and consists of one question for the investigator: Compared to his condition at the start of the study, how much has this patient changed? which is rated on a seven-point scale (1=very much improved; 2=much improved; 3=minimally improved; 4=no change from baseline; 5=minimally worse; 6= much worse; 7=very much worse). Higher scores indicate greater severity of illness. Values closest to 1 for this outcome measure indicate the greatest improvement of symptoms. ANCOVA model was used with treatment as a fixed effect and the baseline CGI-Severity (CGI-S) score as a covariate."|Baseline, Week 8|Participants from the Full Analysis Set (FAS), defined as all participants who were randomized and received at least 1 dose of study drug, who had data available for this outcome measure. One participant in the Vortioxetine 10 mg group was excluded due to a major protocol deviation. Last Observation Carried Forward (LOCF).||scores on a scale||Standard Error|Least Squares Mean
698492|NCT01355081|Secondary|Change From Baseline in the Hamilton Depression Scale (HAM-D17) Total Score After 8 Weeks of Treatment|The HAM-D17 is a 17-item rating scale that assesses depressed mood, agitation and somatic symptoms of depression, rated on a 5-point scale from 0 (absent) to 4 (very severe) with a total score range from 0 to 52. Higher scores indicate greater severity of depression symptoms. A negative change from Baseline indicates that symptoms have improved. ANCOVA model was used with treatment as a fixed effect and the baseline HAM-D17 score as a covariate.|Baseline, Week 8|Participants from the Full Analysis Set (FAS), defined as all participants who were randomized and received at least 1 dose of study drug, who had data available for this outcome measure. One participant in the Vortioxetine 10 mg group was excluded due to a major protocol deviation. Last Observation Carried Forward.||scores on a scale||Standard Error|Least Squares Mean
698493|NCT01355081|Secondary|Percentage of Patients With MADRS Remission After 8 Weeks of Treatment|MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension) rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression) with a total possible score range from 0 to 60. Higher scores indicate greater severity of symptoms. Remission is defined as a MADRS Total Score ≤10.|Week 8|Participants from the Full Analysis Set (FAS), defined as all participants who were randomized and received at least 1 dose of study drug, who had data available for this outcome measure. One participant in the Vortioxetine 10 mg group was excluded due to a major protocol deviation.||percentage of participants|||Number
698494|NCT01355081|Secondary|Percentage of Patients With MADRS Response After 8 Weeks of Treatment|MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension) rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression) with a total possible score range from 0 to 60. Higher scores indicate greater severity of symptoms. Response is defined as a ≥50% decrease in the MADRS Total Score from Baseline.|Baseline, Week 8|Participants from the Full Analysis Set (FAS), defined as all participants who were randomized and received at least 1 dose of study drug, who had data available for this outcome measure. One participant in the Vortioxetine 10 mg group was excluded due to a major protocol deviation.||percentage of participants|||Number
698495|NCT01355081|Primary|Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score After 8 Weeks of Treatment|MADRS is a 10-item clinician rated scale that measures overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension) rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression) with a total possible score range from 0 to 60. Higher scores indicate greater severity of symptoms. A negative change from Baseline indicates that symptoms have improved. An analysis of covariance (ANCOVA) model was used with change in MADRS total score as a dependent variable, treatment as a fixed effect and the baseline MADRS total score as a covariate.|Baseline, Week 8|Participants from the Full Analysis Set (FAS), defined as all participants who were randomized and received at least 1 dose of study drug; who had data available for this outcome measure. One participant in the Vortioxetine 10 mg group was excluded due to a major protocol deviation. Last observation carried forward.||scores on a scale||Standard Error|Least Squares Mean
698496|NCT01355068|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hrs post-dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||hr||Full Range|Median
698497|NCT01355068|Secondary|Plasma Decay Half Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hrs post-dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.||hr||Standard Deviation|Mean
698498|NCT01355068|Secondary|Extrapolated Area Under the Curve (AUC Percent [%] Extrap)|AUC%extrap is the percentage of AUC [0-∞] obtained by forward extrapolation. It is calculated as (AUC [0-∞] minus AUClast)*100/ AUC [0-∞], where AUC [0-∞] = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-∞) and AUClast is area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration.|0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hrs post-dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||Percent AUC||Standard Deviation|Geometric Mean
698499|NCT01355068|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0-∞])|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hrs post-dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.||ng*hr/mL||Standard Deviation|Geometric Mean
698500|NCT01355068|Primary|Maximum Observed Plasma Concentration (Cmax)||0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hrs post-dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng/mL||Standard Deviation|Geometric Mean
698501|NCT01355068|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast).|0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, and 72 hours (hrs) post-dose|Pharmacokinetic (PK) parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng*hr/mL||Standard Deviation|Geometric Mean
698502|NCT01354990|Primary|Number of Participants With Concomitant Conditions||Up to approximately 28 months|||participants|||Number
698503|NCT01354990|Primary|Number of Participants With Concomitant Therapies||Up to approximately 28 months|||participants|||Number
698504|NCT01354990|Primary|Age of Participants Prescribed Sitagliptin||Up to approximately 28 months|||years||Standard Deviation|Mean
698505|NCT01354990|Primary|Number of Participants With an Adverse Event||Up to approximately 28 months|||participants|||Number
698506|NCT01354938|Primary|Number of Participants With a Minimal Clinically Important Difference (MCID) in SGRQ Total Score at End of Treatment|The SGRQ is a 50-item questionnaire with 76 weighted responses. It provides a Total score and three component scores: Symptoms (distress caused by respiratory symptoms), Activity (physical activities that cause or are limited by breathlessness), and Impacts (social and psychological effects of the disease). The Total score and each of the SGRQ subscores are scored from 0 to 100 where 0 indicates best and 100 indicates worst health. An increase in score indicates worsening health. The change from Baseline of 4 or more units lower, consistent with a clinically significant change in the participant, was considered in this study to be the ‘minimal clinically important difference’ (MCID).|Baseline, End of Treatment (maximum treatment duration of 10 days)|Participants with evaluable data||participants|||Number
698507|NCT01354938|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|AE=any untoward medical occurrence in a patient, which does not necessarily have a causal relationship with their treatment. SAE=an event meeting any of the following criteria: results in death, hospitalization, prolongation of hospitalization, is life-threatening, congenital anomaly, persistent or significant disability/incapacity, important medical event requiring medical or surgical intervention, spontaneous or elective abortion. AEs and SAEs were collected during the course of the study. See the Reported Adverse Event section for details.|From start of treatment (maximum treatment duration was 10 days) through last follow up visit (3 to 4 weeks after end of treatment)|All enrolled participants||participants|||Number
698508|NCT01354938|Primary|St. George's Respiratory Questionnaire (SGRQ) Scores at Baseline and End of Treatment|The SGRQ is a 50-item questionnaire with 76 weighted responses. It provides a Total score and three component scores: Symptoms (distress caused by respiratory symptoms), Activity (physical activities that cause or are limited by breathlessness), and Impacts (social and psychological effects of the disease). The Total score and each of the SGRQ subscores are scored from 0 to 100 where 0 indicates best and 100 indicates worst health. An increase in score indicates worsening health. A change in the Total score of 4 units is consistent with a clinically significant change in the participant.|Baseline, End of Treatment (maximum treatment duration of 10 days)|Participants with evaluable data||units on a scale||Standard Deviation|Mean
698509|NCT01354899|Secondary|Overall Experience of Use of the Dressing|Overall experience of use of the dressing rated on a scale from Very Poor, Poor, Good, Very Good, Excellent|During 5 days|||participants|||Number
698510|NCT01354899|Primary|Erythema (No/Yes)|Measure number of skin breakdown during from enrolment to termination.|During 5 days|||participants|||Number
698511|NCT01354652|Secondary|Overall OLT-free Survival|Overall OLT-free survival until development of OLT and death and participants will be followed for the duration of hospital stay or outpatients visit, an expected average of 12 months|Participants will be followed for the duration of hospital stay or outpatients visit, an expected average of 12 months||||||
698512|NCT01354652|Secondary|Arterial pH and Anion Gap in Cases With Elevated Blood Lactate Levels (at the Time of Detection and Peak Levels|Arterial pH and anion gap in cases with elevated blood lactate levels (at the time of detection and peak levels until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.|Participants will be followed for the duration of hospital stay, an expected average of 8 weeks||||||
698513|NCT01354652|Secondary|Frequency of Concomitant Prescribed Medications Possibly Associated With Lactic Acidosis Other Than NTRIs|Frequency of concomitant prescribed medications possibly associated with lactic acidosis other than NTRIs until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.|Participants will be followed for the duration of hospital stay, an expected average of 8 weeks||||||
698514|NCT01354652|Secondary|Incidence of Elevated Venous Lactate Levels More Than 2 mmol/L Caused by Etiologies Other Than NTRIs|incidence of elevated venous lactate levels more than 2 mmol/L caused by etiologies other than NTRIs until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.|Participants will be followed for the duration of hospital stay, an expected average of 8 weeks||||||
698890|NCT01350973|Secondary|Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings After Study Drug Administration||12 Weeks|Safety Analysis Set included all participants who received at least one dose of the investigational product.||participants|||Number
698516|NCT01354652|Primary|Incidence of Elevated Venous Lactate Levels More Than 2 mmol/L of Any Etiology|incidence of elevated venous lactate levels more than 2 mmol/L of any etiology until development of lactic acidosis, orthotropic liver transplantation (OLT), death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.|participants will be followed for the duration of hospital stay, an expected average of 8 weeks|Our study was terminated early with only 5 participant enrolled. We gained lactic acid levels for the 5 patients (all elevated), however we considered that it was not sufficient to be analyzed. Morever, we did not further investigate the etiology for elevated lactic acid levels in the 5 patients and secondary outcomes were not recorded here.||participants|||Number
698522|NCT01354314|Secondary|Change in CES-D Score - Per Protocol|Functional assessment: Change in Center for Epidemiologic Studies Depression Scale (CES-D) score between baseline and week 24 for all participants for whom baseline and follow-up CES-D data are available (per protocol).|24 Weeks|Per protocol analysis: Includes participants who completed the study per protocol and with test data available at the Baseline and Week 24 visits.||units on a scale||Standard Deviation|Mean
698523|NCT01354314|Secondary|Change in CES-D Score - Intent to Treat|Functional assessment: Change in Center for Epidemiologic Studies Depression Scale (CES-D) score between baseline and week 24 for all participants for whom baseline and follow-up CES-D data are available (intent to treat analysis).|24 Weeks|Includes all participants who completed the study with test data available at the Baseline and Week 24 visits for Intention to Treat analysis.||units on a scale||Standard Deviation|Mean
698524|NCT01354314|Secondary|Neurocognitive Performance: NPZ-8 - Per Protocol|Baseline to Week 24 change in neurocognitive performance as measured by NPZ-8 scores calculated for all participants who completed the trial with measurable Baseline and Week 24 data for at least 6 of the 8 data points. The data points that comprise the NPZ-8 include timed gait, symbol-digit, grooved pegboard dominant and non-dominant, CalCAP Choice reaction time and Sequential reaction time, Trail-making Test A and B. The baseline to week 24 changes for each test were averaged to get each change in NPZ-8 score.|24 Weeks|Per protocol analysis: Includes participants who completed the study per protocol and with test data available at the Baseline and Week 24 visits.||Z score||Standard Deviation|Mean
698525|NCT01354314|Secondary|Neurocognitive Performance: NPZ-8 - Intent to Treat|Baseline to Week 24 change in neurocognitive performance as measured by NPZ-8 scores calculated for all participants who completed the trial with measurable Baseline and Week 24 data for at least 6 of the 8 data points. The data points that comprise the NPZ-8 include timed gait, symbol-digit, grooved pegboard dominant and non-dominant, CalCAP Choice reaction time and Sequential reaction time, Trail-making Test A and B. The baseline to week 24 changes for each test were averaged to get each change in NPZ-8 score.|24 Weeks|Includes all participants who completed the study with test data available at the Baseline and Week 24 visits for Intention to Treat analysis.||Z score||Standard Deviation|Mean
698526|NCT01354314|Secondary|Neurocognitive Performance: Timed Gait - Per Protocol|Baseline to Week 24 change in neurocognitive performance as measured by Timed Gait, three-trial average time (Z scores).|24 Weeks|Per protocol analysis: Includes participants who completed the study per protocol and with test data available at the Baseline and Week 24 visits.||Z score||Standard Deviation|Mean
698527|NCT01354314|Secondary|Neurocognitive Performance: Timed Gait - Intent to Treat|Baseline to Week 24 change in neurocognitive performance as measured by Timed Gait, three-trial average time (Z scores).|24 Weeks|Includes all participants who completed the study with test data available at the Baseline and Week 24 visits for Intention to Treat analysis.||Z score||Standard Deviation|Mean
698528|NCT01354314|Secondary|Neurocognitive Performance: Symbol-Digit Test - Per Protocol|Baseline to Week 24 change in neurocognitive performance as measured by Symbol-Digit Test score, number correct in 120 seconds (Z scores).|24 Weeks|Per protocol analysis: Includes participants who completed the study per protocol and with test data available (no data substitution) at the Baseline and Week 24 visits.||Z score||Standard Deviation|Mean
698529|NCT01354314|Secondary|Neurocognitive Performance: Symbol-Digit Test - Intent to Treat|Baseline to Week 24 change in neurocognitive performance as measured by Symbol-Digit Test score, number correct in 120 seconds (Z scores).|24 Weeks|Includes all participants who completed the study with test data available (no data substitution) at the Baseline and Week 24 visits for Intention to Treat analysis.||Z score||Standard Deviation|Mean
698530|NCT01354314|Secondary|Neurocognitive Performance: CalCAP, Sequential - Per Protocol|Baseline to Week 24 change in neurocognitive performance as measured by the CalCAP Sequential test, mean reaction time (Z scores).|24 Weeks|Per protocol analysis: Includes participants who completed the study per protocol and with test data available at the Baseline and Week 24 visits.||Z score||Standard Deviation|Mean
698531|NCT01354314|Secondary|Neurocognitive Performance: CalCAP, Sequential - Intent to Treat|Baseline to Week 24 change in neurocognitive performance as measured by the CalCAP Sequential test, mean reaction time (Z scores).|24 Weeks|Includes all participants who completed the study with test data available at the Baseline and Week 24 visits for Intention to Treat analysis.||Z score||Standard Deviation|Mean
698532|NCT01354314|Secondary|Neurocognitive Performance: CalCAP, Choice - Per Protocol|Baseline to Week 24 change in neurocognitive performance as measured by the CalCAP Choice test, mean reaction time (Z scores).|24 Weeks|Per protocol analysis: Includes participants who completed the study per protocol and with test data available at the Baseline and Week 24 visits.||Z score||Standard Deviation|Mean
698533|NCT01354314|Secondary|Neurocognitive Performance: CalCAP, Choice - Intent to Treat|Baseline to Week 24 change in neurocognitive performance as measured by the CalCAP Choice test, mean reaction time (Z scores).|24 Weeks|Includes all participants who completed the study with test data available at the Baseline and Week 24 visits for Intention to Treat analysis.||Z score||Standard Deviation|Mean
698534|NCT01354314|Secondary|Neurocognitive Performance: Grooved Pegboard, Non-Dominant - Per Protocol|Baseline to Week 24 change in neurocognitive performance as measured by the Grooved Pegboard test, non-dominant hand speed of completion (Z scores).|24 Weeks|Per protocol analysis: Includes all participants who completed the study per protocol and with test data available at the Baseline and Week 24 visits.||Z score||Standard Deviation|Mean
698535|NCT01354314|Secondary|Neurocognitive Performance: Grooved Pegboard, Non-Dominant - Intent to Treat|Baseline to Week 24 change in neurocognitive performance as measured by the Grooved Pegboard test, non-dominant hand speed of completion (Z scores).|24 Weeks|Includes all participants who completed the study with test data available at the Baseline and Week 24 visits for Intention to Treat analysis.||Z score||Standard Deviation|Mean
698536|NCT01354314|Secondary|Neurocognitive Performance: Grooved Pegboard, Dominant - Per Protocol|Baseline to Week 24 change in neurocognitive performance as measured by the Grooved Pegboard test, dominant hand speed of completion (Z scores).|24 Weeks|Per protocol analysis: Includes all participants who completed the study per protocol and with test data available at the Baseline and Week 24 visits.||Z score||Standard Deviation|Mean
698537|NCT01354314|Secondary|Neurocognitive Performance: Grooved Pegboard, Dominant - Intent to Treat|Baseline to Week 24 change in neurocognitive performance as measured by the Grooved Pegboard test, dominant hand speed of completion (Z scores).|24 Weeks|Includes all participants who completed the study with test data available at the Baseline and Week 24 visits for Intention to Treat analysis.||Z score||Standard Deviation|Mean
698538|NCT01354314|Secondary|Neurocognitive Performance: Trail Making B - Per Protocol|Baseline to Week 24 change in neurocognitive performance as measured by the Trail-making test, part B speed of completion (Z scores).|24 Weeks|Per protocol analysis: Includes all participants who completed the study per protocol and with test data available at the Baseline and Week 24 visits.||Z score||Standard Deviation|Mean
698539|NCT01354314|Secondary|Neurocognitive Performance: Trail Making B - Intent to Treat|Baseline to Week 24 change in neurocognitive performance as measured by the Trail-making test, part B speed of completion (Z scores).|24 Weeks|Includes all participants who completed the study with test data available at the Baseline and Week 24 visits for Intention to Treat analysis.||Z score||Standard Deviation|Mean
698540|NCT01354314|Secondary|Neurocognitive Performance: Trail Making A - Per Protocol|Baseline to Week 24 change in neurocognitive performance as measured by the Trail-making test, part A speed of completion (Z scores).|24 Weeks|Per protocol analysis: Includes all participants who completed the study per protocol and with test data available at the Baseline and Week 24 visits.||Z score||Standard Deviation|Mean
698541|NCT01354314|Secondary|Neurocognitive Performance: Trail Making A - Intent to Treat|Baseline to Week 24 change in neurocognitive performance as measured by the Trail-making test, part A speed of completion (Z scores).|24 Weeks|Includes all participants who completed the study with test data available at the Baseline and Week 24 visits for Intention to Treat analysis.||Z score||Standard Deviation|Mean
698542|NCT01354314|Secondary|Change in CSF Neurofilament Protein Heavy Chain (pNFH) Between Baseline and Week 24 - Per Protocol|CSF immune and neuronal injury markers: Change in CSF neurofilament protein heavy chain (pNFH) between baseline and week 24 for participants with 90% or greater study drug adherence and for whom baseline and follow-up CSF data are available (per protocol analysis).|24 Weeks|For per protocol analysis, 18 participants (out of the 22 who completed the trial with 90% or greater study drug adherence) had follow-up CSF for primary outcome measures.||pg/mL||Inter-Quartile Range|Median
698543|NCT01354314|Secondary|Change in CSF Neurofilament Protein Heavy Chain (pNFL) Between Baseline and Week 24 - Intent to Treat|CSF immune and neuronal injury markers: Change in CSF neurofilament protein heavy chain (pNFL) between baseline and week 24 for all participants for whom baseline and follow-up CSF data are available (intent to treat analysis).|24 Weeks|31 participants, out of the total 45 enrolled, completed the trial with follow-up CSF primary outcome measures.||pg/mL||Inter-Quartile Range|Median
698544|NCT01354314|Secondary|Change in CSF Neurofilament Protein Light Chain (NFL) Between Baseline and Week 24 - Per Protocol|CSF immune and neuronal injury markers: Change in CSF neurofilament protein light chain (NFL) between baseline and week 24 for participants with 90% or greater study drug adherence and for whom baseline and follow-up CSF data are available (per protocol analysis).|24 Weeks|For per protocol analysis, 18 participants (out of the 22 who completed the trial with 90% or greater study drug adherence) had follow-up CSF for primary outcome measures.||pg/mL||Inter-Quartile Range|Median
698545|NCT01354314|Secondary|Change in CSF Neurofilament Protein Light Chain (NFL) Between Baseline and Week 24 - Intent to Treat|CSF immune and neuronal injury markers: Change in CSF neurofilament protein light chain (NFL) between baseline and week 24 for all participants for whom baseline and follow-up CSF data are available (intent to treat analysis).|24 Weeks|31 participants, out of the total 45 enrolled, completed the trial with follow-up CSF primary outcome measures.||pg/mL||Inter-Quartile Range|Median
698546|NCT01354314|Secondary|Change in CSF CD163 Between Baseline and Week 24 - Per Protocol|CSF immune and neuronal injury markers: Change in CSF CD163 between baseline and week 24 for participants with 90% or greater study drug adherence and for whom baseline and follow-up CSF data are available (per protocol analysis).|24 Weeks|For per protocol analysis, 18 participants (out of the 22 who completed the trial with 90% or greater study drug adherence) had follow-up CSF for primary outcome measures.||ng/mL||Inter-Quartile Range|Median
698547|NCT01354314|Secondary|Change in CSF CD163 Between Baseline and Week 24 - Intent to Treat|CSF immune and neuronal injury markers: Change in CSF CD163 between baseline and week 24 for all participants for whom baseline and follow-up CSF data are available (intent to treat analysis).|24 Weeks|31 participants, out of the total 45 enrolled, completed the trial with follow-up CSF primary outcome measures.||ng/mL||Inter-Quartile Range|Median
698548|NCT01354314|Secondary|Change in CSF sCD14 Between Baseline and Week 24 - Per Protocol|CSF immune and neuronal injury markers: Change in CSF sCD14 between baseline and week 24 for participants with 90% or greater study drug adherence and for whom baseline and follow-up CSF data are available (per protocol analysis).|24 Weeks|For per protocol analysis, 18 participants (out of the 22 who completed the trial with 90% or greater study drug adherence) had follow-up CSF for primary outcome measures.||pg/mL||Inter-Quartile Range|Median
698549|NCT01354314|Secondary|Change in CSF sCD14 Between Baseline and Week 24 - Intent to Treat|CSF immune and neuronal injury markers: Change in CSF sCD14 between baseline and week 24 for all participants for whom baseline and follow-up CSF data are available (intent to treat analysis).|24 Weeks|31 participants, out of the total 45 enrolled, completed the trial with follow-up CSF primary outcome measures.||pg/mL||Inter-Quartile Range|Median
698550|NCT01354314|Primary|Change in CSF 3-nitrosylated Protein Levels Between Baseline and Week 24 - Per Protocol|CSF lipid and protein markers of oxidative stress: Change in 3-nitrosylated protein levels between baseline and week 24 for participants with 90% or greater adherence to study drug and for whom CSF data are available (per protocol analysis).|24 Weeks|For per protocol analysis, 18 participants (out of the total 22 who completed the trial with 90% or greater study drug adherence) had follow-up CSF for primary outcome measures.||pi*mm^2||Inter-Quartile Range|Median
698551|NCT01354314|Primary|Change in CSF 3-nitrosylated Protein Levels Between Baseline and Week 24 - Intent to Treat|CSF lipid and protein markers of oxidative stress: Change in 3-nitrosylated protein levels between baseline and week 24 for all participants for whom CSF data are available (intent to treat analysis).|24 Weeks|For intention to treat analysis, 31 participants, out of the total 45 enrolled, completed the trial with follow-up CSF primary outcome measures.||pi*mm^2||Inter-Quartile Range|Median
698552|NCT01354314|Primary|Change in CSF Ceramide Between Baseline and Week 24 (C18:0 Levels) - Per Protocol|CSF lipid and protein markers of oxidative stress: Change in CSF ceramide (C18:0 levels) between baseline and week 24 for participants with 90% or greater study drug adherence and for whom baseline and follow-up CSF data are available (per protocol analysis).|24 Weeks|For per protocol analysis, 18 participants (out of the 22 who completed the trial with 90% or greater study drug adherence) had follow-up CSF for primary outcome measures.||ng/mL||Inter-Quartile Range|Median
698553|NCT01354314|Primary|Change in CSF Ceramide Between Baseline and Week 24 (C18:0 Levels) - Intent to Treat|CSF lipid and protein markers of oxidative stress: Change in CSF ceramide (C18:0 levels) between baseline and week 24 for all participants for whom baseline and follow-up CSF data are available (intent to treat analysis).|24 Weeks|31 participants, out of the total 45 enrolled, completed the trial with follow-up CSF primary outcome measures.||ng/mL||Inter-Quartile Range|Median
698554|NCT01354223|Secondary|Evaluation of Average Lens Wearing Time - Average Daily Hours Worn|The secondary efficacy endpoint is the objective assessment of the lens average daily wearing times associated with the stenfilcon A compared with the lens average wearing times with the ocufilcon B contact lens. Objective average daily lens wearing time is measured in reported hours worn with the subject's habitual contact lenses recorded at baseline and after dispensing of study lenses recorded at Week 1, Week 2, Month 1, Month 2, Month 3.|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3|||hours||Standard Deviation|Mean
698579|NCT01354132|Secondary|Glutamate Brain Level for Placebo Group|Glutamine is measured in the medial prefrontal cortex using Magnetic Resonance Spectroscopy (H-MRS) and is a chemical that works to protect the brain from high levels of excitatory chemicals such as glutamate.|at 6 months|The number of subjects in the NAC and Placebo group is lower as not everyone in the study agreed to a MRS, in addition the MRS was only done at the Switzerland site.||mM||Standard Deviation|Mean
698555|NCT01354223|Primary|Comparison of Objective Findings for Contact Lens Visual Acuities - Snellen 20/25 VA or Better|"The primary efficacy endpoint are the contact lens Snellen visual acuities (VA) of 20/25 VA or better associated with stenfilcon A compared with those same visual acuities associated with ocufilcon B.
Snellen visual acuity (VA) examinations were performed at All Follow-up visits (week 1 visit, week 2 visit, month 1 visit, month 2 visit). The combined results of All Follow-up visits are compared."|week 1 visit, week 2 visit, month 1 visit, month 2 visit combined|For the completed study subjects, contact lens VA was collected at 562 of the possible 564 examinations (99.6%) for the Test cohort eyes and at 288 of the possible 288 examinations (100%) for the Control cohort eyes.||percentage of possible examinations|Participants||Number
698556|NCT01354223|Secondary|Subjective Assessment of Contact Lens Comfort - No Symptoms of Discomfort|"The secondary efficacy endpoint is the subjective assessment of contact lens comfort associated with the stenfilcon A contact lens compared with the comfort associated with the ocufilcon B contact lens.
Subjective comfort assessment is related by the percent number of unique eyes that were reported to have no symptoms of discomfort (0=no symtoms reported) graded on a severity scale of the reported symptoms (0=no symptoms reported, 4=severe) that was experienced over the past month prior to baseline at the baseline visit (Baseline) and any symptoms of discomfort that was experienced since the previous study visit at each scheduled follow-up visit (Week 1, Week 2, Month 1, Month 2, Month 3)."|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3|Unique eyes reporting no symptoms of discomfort/Pain, excessive tearing, photophobia, halos, itching/burning, dryness, variable vision, blurred vision, other symptoms.||percentage of eyes|Participants||Number
698557|NCT01354223|Primary|Comparison of Objective Findings - Number of Adverse Events in Unique Eyes|"The primary safety endpoint in this evaluation will be a comparison of the objective findings of the number of adverse events in unique eyes associated with the stenfilcon A contact lenses compared with those same findings as associated with ocufilcon B contact lenses.
The number of adverse events over the duration of the study was reported for each unique eye (bilateral or unilateral). Observations for adverse events were reported for any occurrence after dispensing (dispensing visit) through end of month 3 visit (month 3 visit)."|Any occurrence from dispensing to month 3 visit|Unique eyes are defined as each individual eye in the study.||number of adverse events|Participants||Number
698558|NCT01354223|Primary|Objective Assessment: Ocular Response - Biomicroscopy|"The primary safety endpoint are the objective slit lamp findings associated with the stenfilcon A contact lenses compared with those same findings reported as associated with the ocufilcon B contact lenses.
The incidence of biomicroscopy findings (0=not present, 4=severe) over the duration of the study with the highest reported grade was chosen for each unique eye. Biomicroscopy measurements were obtained at Baseline (baseline visit) and All Follow-Ups (week 1 visit, week 2 visit, month 1 visit, month 2 visit combined).The average grade for unique eyes with findings greater than 0 (none) is compared."|Change from baseline visit and all follow-ups visits|Unique eyes are defined as each individual eye in the study and are only counted once for each of the visit groupings||units on a scale|Participants|Full Range|Mean
698559|NCT01354197|Secondary|Readmission to ICU|Number of Participants with Readmission to ICU up to 3 days (72 hours) after discharge from ICU|3 days|||participants|||Number
698560|NCT01354197|Primary|Overall Mortality|Number of Participants who Did Not Survive up to 28 days after surgical ICU admission|28 days|||participants|||Number
698561|NCT01354145|Secondary|Use of Acetaminophen|"Consumption of Acetaminophen: At each post-baseline visit, the investigator had to assess the consumption of acetaminophen, rescue analgesic authorised throughout the study, by reporting the number of caplets dispensed/retrieved since the previous visit.
Daily consumption of acetaminophen was calculated as an average."|3 months (Day 91), 6 momnths (Day 182), 12 months (Day 364), 18 monts (Day 546) and 24 months (Day 728)|Intention-To-Treat||Daily number of caplets taken||Standard Deviation|Mean
698562|NCT01354145|Secondary|Percentage of Participants With Presence of Joint Swelling and Effusion|Study knees were evaluated at each visit for the presence or absence of swelling and effusion.|Baseline, 12 months (Day 364) and 24 months (Day 728)|Intention-To-Treat||percentage of participants|||Number
698563|NCT01354145|Secondary|Short Form (SF-36) Health Survey|"The SF-36 is composed of 35 items measuring:
8 health concepts (or dimensions), [(Physical Functioning (PF), Role Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role Emotional (RE) and Mental Health (MH)]
and 1 reported health transition item.
The 8 health concepts are summarized in 1 physical (PCS) and 1 mental (MCS) component summary measures. PCS is represented by physical function, role limitations-physical, pain, and general health perception. MCS is represented by vitality, social function, role limitations-emotional, and mental health. Subscale items are summed and scaled from 0-100 to give subscale scores; 0= worst health related quality of life (HRQL), 100=best HRQL. PCS and MCS summary scores are constructed as T-scores (mean =50, standard deviation=10) with no minimum or maximum score; higher scores indicate better health status."|Baseline, 12 months (Day 364) and 24 months (Day 728)|Intention-To-Treat||Scores on a scales||Standard Deviation|Median
698564|NCT01354145|Secondary|WOMAC Function Subscale|Western Ontario & McMaster Universities Osteoarthritis Index, from 0 No Function to 170 Maximum Function WOMAC functional limitation subscale was used to measure the functionality of the knee with pain. Seventeen items are used to assess functionality of the knee: tair use, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy household duties, light household duties. Each item is a 10 cm VAS with 0 and 10 cm representing no difficulty and extreme difficulty respectively.|Baseline, 12 months (Day 364) and 24 months (Day 728)|Intention-To-Treat||centimeters||Standard Deviation|Mean
698565|NCT01354145|Secondary|WOMAC Stiffness Subscale|Western Ontario & McMaster Universities Osteoarthritis Index, from 0 No Stiffness to 20 Maximum Stiffness WOMAC stiffness subscale was used to measure the stiffness of the knee with pain. Two items are used to assess stiffness grade: after first waking and later in the day.Each item is a 10 cm VAS with 0 and 10 cm representing no difficulty and extreme difficulty respectively.|Baseline, 12 months (Day 364) and 24 months (Day 728)|Intention-To-Treat||centimeters||Standard Deviation|Mean
698580|NCT01354132|Secondary|Glutamate Brain Level for NAC Group|Brain marker, glutamate, was measured using Magnetic Resonance Spectroscopy (H-MRS) in the medial prefrontal cortex. Glutamate is an excitatory neurotransmitter in the brain.|at 6 months|The number of subjects in the NAC and Placebo group is lower as not everyone in the study agreed to a MRS, in addition the MRS was only done at the Switzerland site.||mM||Standard Deviation|Mean
698566|NCT01354145|Secondary|WOMAC Pain Subscale|Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) Pain subscale Score Range: 0 (no pain) - 50 (maximum pain) The study was designed such that the outcome of primary interest is knee pain related to OA. The measure selected to best evaluate this is an improvement in the WOMAC pain subscales. This subscale consists of 5 items which assesses the pain during walking, using stairs, in bed, sitting or lying, and standing.Each item is a 10 cm VAS with 0 and 10 cm representing no pain and extreme pain respectively.|Baseline, 12 months (Day 364) and 24 months (Day 728)|Intention-To-Treat||centimeters||Standard Deviation|Mean
698567|NCT01354145|Secondary|Visual Analog Scale (VAS)|Visual Analogue Scale: 0 No Pain 10 Maximum Pain Huskisson’s VAS measures global pain intensity. Patients were asked to quantify their disease status on a 10 cm VAS as follows: “Please indicate the severity of knee pain experienced during the last 48 hours by marking a (I) through the line”. Left hand marker represents “No pain” and right hand marker represents “The worst pain imaginable”.|Baseline, 12 months (Day 364) and 24 months (Day 728)|Intention-To-Treat||centimeters||Standard Deviation|Mean
698568|NCT01354145|Secondary|Percentage of Participants With the Presence of Extrusion in the Meniscus|The presence of a meniscal extrusion was assessed in each of sub regions. The absence of a severe extrusion in all the sub regions was considered as an absence (score=0) of a severe extrusion in the meniscus. The presence of a severe extrusion in at least one region of the meniscus was sufficient to consider the presence (score=1) of a severe extrusion in the meniscus.|Baseline, 12 months (Day 364) and 24 months (Day 728)|Intention-To-Treat||percentage of participants|||Number
698569|NCT01354145|Secondary|Synovial Fluid Volume|To compare the synovial fluid volume of the global knee at the Baseline visit and after 24 months.|Baseline, 12 months (Day 364) and 24 months (Day 728)|Intention-To-Treat||mililiters||Standard Deviation|Mean
698570|NCT01354145|Secondary|Bone Marrow Lesions Score|"To compare the bone marrow lesions (BMLs) score in the global knee and the different sub regions at the baseline visit and the follow-up visits in subjects treated either with CHONDROITIN SULPHATE (CONDROSAN) or CELECOXIB.
The BMLs were assessed in the global knee and the different sub region of the knee (medial trochlea, plateau of the medial femoro-tibial joint, femur of the medial femoro-tibial joint, medial posterior condyle, lateral trochlea, plateau of the lateral femoro-tibial joint, femur of the lateral femoro-tibial joint, lateral posterior femur). The BMLs score was defined as a grade (between 0 and 3) in each knee sub region and summed to derive a global knee score ranging between 0 (absent) and 30 (present). Specifically, each grade was scored as follows:
Grade 0 = Absence of lesion in the sub region
Grade 1 = less than 25% of the surface
Grade 2 = 25-50% of the surface
Grade 3 = more than 50% of the surface"|Baseline, 12 months (Day 364) and 24 months (Day 728)|Intention-To-Treat||units on a scale||Standard Deviation|Mean
698571|NCT01354145|Secondary|Synovial Membrane Thickness|"To compare the severity of synovitis score (Thickness of the Synovial Membrane in mm) in Global Knee , at the baseline visit and the follow-up visits in subjects treated either with CHONDROITIN SULPHATE (CONDROSAN) or CELECOXIB.
The severity of synovitis was evaluated through four regions of interest (ROIs) in the images of the axial T1-weighted acquisition complemented with the use of the images of the axial T2-weighted acquisition. The thickness of the synovial membrane was evaluated in the global knee and each of the ROIs and results were expressed in millimetres. The four ROIs were the proximal lateral, distal lateral, proximal medial and distal medial."|Baseline, 12 months (Day 364) and 24 months (Day 728)|Intention-To-Treat||milimeters||Standard Deviation|Mean
698572|NCT01354145|Secondary|Cartilage Volume in the Medial Compartment|To compare the cartilage volume loss of the medial compartment at the Baseline visit and after 12 and 24 months.|12 months (Day 364) and 24 months (Day 728)|Intention-To-Treat||cubic milimeters||Standard Deviation|Mean
698573|NCT01354145|Secondary|Cartilage Volume Loss of the Global Knee|To compare the cartilage volume loss of the global knee at the Baseline visit and after 12 and 24 months.|12 months (Day 364) and 24 months (Day 728)|Intention-to-Treat||cubic milimeters||Standard Deviation|Mean
698574|NCT01354145|Primary|Cartilage Volume Loss of the Lateral Compartment|To compare the cartilage volume loss of the lateral compartment (femoral condyle and tibial plateau) at the Baseline visit and after 12 and 24 months of treatment either with CHONDROITIN SULPHATE (CONDROSAN) 1200 mg daily or with CELECOXIB 200 mg daily.|12 months (Day 364) and 24 months (Day 728)|Intention-To-Treat||cubic milimeters||Standard Deviation|Mean
698575|NCT01354132|Secondary|Myo-Inositol Brain Level for Placebo Group|Myo-Inositol is measured in the medial prefrontal cortex using Magnetic Resonance Spectroscopy (H-MRS)MRS and is a chemical that works to protect the brain from high levels of excitatory chemicals such as glutamate.|at 6 months|The number of subjects in the NAC and Placebo group is lower as not everyone in the study agreed to a MRS, in addition the MRS was only done at the Switzerland site.||mM||Standard Deviation|Mean
698576|NCT01354132|Secondary|Myo-Inositol Brain Level for the NAC Group|Myo-Inositol is measured in the medial prefrontal cortex using Magnetic Resonance Spectroscopy (H-MRS)MRS and is a chemical that works to protect the brain from high levels of excitatory chemicals such as glutamate.|at 6 months|The number of subjects in the NAC and Placebo group is lower as not everyone in the study agreed to a MRS, in addition the MRS was only done at the Switzerland site.||mM||Standard Deviation|Mean
698577|NCT01354132|Secondary|Glutathione Brain Level for Placebo Group|measured by H-MRS in the medial prefrontal cortex Brain markers, glutathione was measured using Magnetic Resonance Spectroscopy (H-MRS) in the medial prefrontal cortex. Glutathione is a tripeptide comprised of three amino acids (cysteine, glutamic acid, and glycine) and acts as an antioxidant, a free radical scavanger and a detoxifying agent. Glutathione is an important co-factor for the enzyme glutathione peroxidase used in the uptake of amino acids.|at 6 months|The number of subjects in the NAC and Placebo group is lower as not everyone in the study agreed to a MRS, in addition the MRS was only done at the Switzerland site.||mM||Standard Deviation|Mean
698578|NCT01354132|Secondary|Glutathione Brain Level for NAC Group|measured by H-MRS in the medial prefrontal cortex Brain markers, glutathione was measured using Magnetic Resonance Spectroscopy (H-MRS) in the medial prefrontal cortex. Glutathione is a tripeptide comprised of three amino acids (cysteine, glutamic acid, and glycine) and acts as an antioxidant, a free radical scavanger and a detoxifying agent. Glutathione is an important co-factor for the enzyme glutathione peroxidase used in the uptake of amino acids.|at 6 months|The number of subjects in the NAC and Placebo group is lower as not everyone in the study agreed to a MRS, in addition the MRS was only done at the Switzerland site.||mM||Standard Deviation|Mean
735118|NCT00423358|Primary|Parathyroid Hormone Level|Serum parathyroid hormone level|1 Year|Subject data were analyzed using the intent to treat approach.||pg/mL||Standard Deviation|Mean
698581|NCT01354132|Secondary|Glutamine Brain Level for Placebo Group|Glutamine is measured in the medial prefrontal cortex using Magnetic Resonance Spectroscopy (H-MRS) and is a chemical that works to protect the brain from high levels of excitatory chemicals such as glutamate.|at 6 months|The number of subjects in the NAC and Placebo group is lower as not everyone in the study agreed to a MRS, in addition the MRS was only done at the Switzerland site.||mM||Standard Deviation|Mean
698582|NCT01354132|Secondary|Glutamine Brain Level for NAC Group|Glutamine is measured in the medial prefrontal cortex using Magnetic Resonance Spectroscopy (H-MRS) and is a chemical that works to protect the brain from high levels of excitatory chemicals such as glutamate.|at 6 months|The number of subjects in the NAC and Placebo group is lower as not everyone in the study agreed to a MRS, in addition the MRS was only done at the Switzerland site.||mM||Standard Deviation|Mean
698583|NCT01354132|Secondary|GPxbc Glutathione Peroxidase Activity in Blood Cells|GPxBC is a measurement of glutathiione peroxidase enzymatic activity in glutathione synthesis and the redox system in blood cells. Measured as umol/min/gHb from blood cells.|at 6 months|||umol/min/gHb||Standard Deviation|Mean
698584|NCT01354132|Secondary|Blood Plasma Level of Cysteine|Cysteine is an amino acid, a building block for proteins and is used throughout the body and was measured in blood plasma.|at 6 months|||uM||Standard Deviation|Mean
698585|NCT01354132|Secondary|Change in Blood Level of Glutathione|Glutathione is a tripeptide comprised of three amino acids (cysteine, glutamic acid, and glycine) and acts as an antioxidant, a free radical scavanger and a detoxifying agent. Glutathione is an important co-factor for the enzyme glutathione peroxidase used in the uptake of amino acids. The level of glutathione is measured in blood cells.|at 6 months|||mM||Standard Deviation|Mean
698586|NCT01354132|Secondary|Change in Cognition and Working Memory (MATRICS) Reasoning and Problem Solving|The MATRICS is neurocognitive battery designed to assess cognition. Problem Solving is a composite score based on the NAB Mazes. The score is a standardized T-Score which indicates the number of standard deviations above or below the mean, a T-Score of 50, in 10 point increments. A T-Score of 60 indicates 1 standard deviation above the mean and a T-Score of 40 indicates 1 standard deviation below the mean. A score below 50 indicated cognitive processing below that of an age and gender matched healthy control population. A score above 50 indicates cognitive processing above that of an age and gender matched healthy control population.|at 6 months|Analysis of cognitive data is based on those who completed the cognitive testing at 6 months which required a separate clinic appointment and thus the overall number of participants is lower due to a loss of that data from failure to keep the cognitive testing appointment.||T- Scores||Standard Deviation|Mean
698587|NCT01354132|Secondary|Change in Cognition and Working Memory (MATRICS) Visual Learning|The MATRICS is neurocognitive battery designed to assess cognition. Visual Learning is a composite score based on the Brief Visuospatial Memory test - Revised: Immediate Recall. The score is a standardized T-Score which indicates the number of standard deviations above or below the mean, a T-Score of 50, in 10 point increments. A T-Score of 60 indicates 1 standard deviation above the mean and a T-Score of 40 indicates 1 standard deviation below the mean. A score below 50 indicated cognitive processing below that of an age and gender matched healthy control population. A score above 50 indicates cognitive processing above that of an age and gender matched healthy control population.|at 6 months|Analysis of cognitive data is based on those who completed the cognitive testing at 6 months which required a separate clinic appointment and thus the overall number of participants is lower due to a loss of that data from failure to keep the cognitive testing appointment.||T- Scores||Standard Deviation|Mean
698588|NCT01354132|Secondary|Change in Cognition and Working Memory (MATRICS) Verbal Learning|The MATRICS is neurocognitive battery designed to assess cognition. Verbal Learning is a composite score based on the Hopkins Verbal Learning Test-Revised: Immediate Recall. The score is a standardized T-Score which indicates the number of standard deviations above or below the mean, a T-Score of 50, in 10 point increments. A T-Score of 60 indicates 1 standard deviation above the mean and a T-Score of 40 indicates 1 standard deviation below the mean. A score below 50 indicated cognitive processing below that of an age and gender matched healthy control population. A score above 50 indicates cognitive processing above that of an age and gender matched healthy control population.|at 6 months|Analysis of cognitive data is based on those who completed the cognitive testing at 6 months which required a separate clinic appointment and thus the overall number of participants is lower due to a loss of that data from failure to keep the cognitive testing appointment.||T- Scores||Standard Deviation|Mean
698589|NCT01354132|Secondary|Change in Cognition and Working Memory (MATRICS) Attention and Vigilance|The MATRICS is neurocognitive battery designed to assess cognition. Sustained attention and Vigilance is a composite score based on the Continuous Performance Test -Identical Pairs. The score is a standardized T-Score which indicates the number of standard deviations above or below the mean, a T-Score of 50, in 10 point increments. A T-Score of 60 indicates 1 standard deviation above the mean and a T-Score of 40 indicates 1 standard deviation below the mean. A score below 50 indicated cognitive processing below that of an age and gender matched healthy control population. A score above 50 indicates cognitive processing above that of an age and gender matched healthy control population.|at 6 months|Analysis of cognitive data is based on those who completed the cognitive testing at 6 months which required a separate clinic appointment and thus the overall number of participants is lower due to a loss of that data from failure to keep the cognitive testing appointment.||T- Scores||Standard Deviation|Mean
698590|NCT01354132|Secondary|Change in Cognition and Working Memory (MATRICS) Working Memory|The MATRICS is neurocognitive battery designed to assess cognition. Working Memory score is a composite score based on the following sub-test WMS-III Spatial Span and Letter-Number Span. The score is a standardized T-Score which indicates the number of standard deviations above or below the mean, a T-Score of 50, in 10 point increments. A T-Score of 60 indicates 1 standard deviation above the mean and a T-Score of 40 indicates 1 standard deviation below the mean. A score below 50 indicated cognitive processing below that of an age and gender matched healthy control population. A score above 50 indicates cognitive processing above that of an age and gender matched healthy control population.|at 6 months|Analysis of cognitive data is based on those who completed the cognitive testing at 6 months which required a separate clinic appointment and thus the overall number of participants is lower due to a loss of that data from failure to keep the cognitive testing appointment.||T- Scores||Standard Deviation|Mean
698605|NCT01353976|Primary|Complete Cure|Complete Cure is defined as a negative KOH and negative fungal culture and no evidence of clinical disease as indicated by scores of 0 (none) for each sign and symptom at Day 43.|Day 43|MITT||Participants|||Number
698591|NCT01354132|Secondary|Change in Cognition and Working Memory (MATRICS) Speed of Processing|The MATRICS is neurocognitive battery designed to assess cognition. Processing speed is a composite score including the following tests: Trail Making Test, BACS: Symbol Coding, Category Fluency: Animal Naming. The score is a standardized T-Score which indicates the number of standard deviations above or below the mean, a T-Score of 50, in 10 point increments. A T-Score of 60 indicates 1 standard deviation above the mean and a T-Score of 40 indicates 1 standard deviation below the mean. A score below 50 indicated cognitive processing below that of an age and gender matched healthy control population. A score above 50 indicates cognitive processing above that of an age and gender matched healthy control population.|at 6 months|Analysis of cognitive data is based on those who completed the cognitive testing at 6 months which required a separate clinic appointment and thus the overall number of participants is lower due to a loss of that data from failure to keep the cognitive testing appointment.||T- Scores||Standard Deviation|Mean
698592|NCT01354132|Secondary|Social and Occupational Functioning Assessment Scale (SOFAS)|"Measure of social and occupational functioning using the Social and Occupational Functioning Assessment Scale Measure Description: Rating of Overall Social and Occupational Functioning on a scale of 1 (worst) to 100 (best) in groups of 10:
100-91: Superior functioning 90-81: Good functioning 80-71: Slight impairment 70-61: Some difficulty 60-51: Moderate difficulty 50-41: Serious impairment 40-31: Major impairment 30-21: Inability to function in almost all areas 20-11: Unable to function independently 10-1: Unable to function without harming self or others"|at 6 months|||units on a scale||Standard Deviation|Mean
698593|NCT01354132|Secondary|Global Assessment of Functioning (GAF)|"Measure Description: Clinical Measure of Global level of Symptoms (Sx) and Functioning from 1 (Worst) to 100 (Best) in groups of 10:
100 - 91: Superior functioning 90 - 81: Absent or minimal Sx 80 - 71: If symptoms are present and expected 70 - 61:Some mild Sx 60 - 51: Moderate Sx 50 - 41: Serious Sx 40 - 31: Some impairment in reality testing or communication 30 - 21: Behavior is considerably influenced by delusions or hallucinations 20 - 11: Some danger of hurting self or others 10 - 1: Persistent danger of severely hurting self or others"|at 6 months|||units on a scale||Standard Deviation|Mean
698594|NCT01354132|Secondary|Change in Positive Symptoms (PANSS)|"Positive and Negative Symptom Scale was used to assess psychopathology. The Positive symptom subscale of schizophrenia includes the sum of items P1 -P7 including P1) Delusions, P2) conceptual Disorganization, P3) Hallunicatory Behavior, P4) Excitement, P5) Grandiosity, P6) Suspiciousness and Persecution, and P7) Hostility and were assessed for the previous week:
RATING SCALE
1: Absent 2: Minimal 3: Mild 4: Moderate 5: Moderate Severe 6: Severe 7: Extreme The higher the score the worse the symptoms. The lowest possible score is 7 and the highest possible score is 49 ."|at 6 months|Analysis was done with participants who completed the 6 month treatment phase||units on a scale||Standard Deviation|Mean
698595|NCT01354132|Primary|Change in Negative Symptoms of Schizophrenia as Measured on the PANSS|"Positive and Negative Symptom Scale was used to assess psychopathology. The sum of items N1 - N7 including N1) blunted affect, N2) emotional withdrawal, N3) poor rapport, N4) passive apathetic social withdrawal, N5) difficulty in abstract thinking, N6) lack of spontaneity and flow of conversation, and N7) sterotyped thinking were used to analyze negative symptoms of schizophrenia and were assessed for the previous week:
RATING SCALE
1: Absent 2: Minimal 3: Mild 4: Moderate 5: Moderate Severe 6: Severe 7: Extreme The higher the score the worse the symptoms. The lowest possible score is 7 and the highest possible score is 49 ."|at 6 months|Analysis was done with those who completed the 6 month treatment protocol.||units on a scale||Standard Deviation|Mean
698596|NCT01354106|Primary|Skin Trauma|"Expert grader using Erythema/Edema Scale 0=No visible response
mild response
moderate response
severe response
extreme response"|24 hours|||Units on a scale||Standard Deviation|Mean
698597|NCT01354028|Primary|Number of Infants Sleeping at the End of the Massage Period|Investigators compared the number of infants sleeping at the end of the massage period with the percentage of infants sleeping at the same time on the non massage day.|Minute massage ended|A convenient number of infants was determined for this pilot study||participants|||Number
698598|NCT01354028|Secondary|Heart Rate|Heart rate during massage therapy|During massage therapy|A convenient size was determined for this pilot study||beats per minute||Standard Deviation|Mean
698599|NCT01354028|Secondary|Oxygen Saturation Levels During Massage|Infants in the NICU are routinely attached to pulse oximeter monitors that measure oxygen saturation continuously. If the infant is stressed, oxygen levels may drop. Oxygen saturation was monitored during massage therapy as a routine measure but also to ensure that infants did not become stressed during the massage.|During massage|We determined a convenient size for this pilot study||percentage of oxygen saturation||Standard Deviation|Mean
698600|NCT01354028|Primary|Quality of Sleep, Defined by Number and Duration of Awakenings, and Longest Sustained Sleep Period for the Study Interval. These Data Were Measured by the Actigraph Software and Summarized as Percentage of Time Spent Sleeping, or Sleep Efficiency|Sleep onset following the first quiet alert state after the 9 AM feed Sleep end time Number of awakenings and duration of the awakenings during the study period Longest sustained sleep period for the study interval Percentage of time spent sleeping, or sleep efficiency, will be used to summarize the data, comparing sleep efficiency over 2 days and using each infant as his/her own control|Participants were followed for two days|A convenient number of participants was selected for this pilot study.||percentage of time spent sleeping||Standard Deviation|Mean
698601|NCT01354015|Secondary|Change in HbA1c Over 3 Months|Change in HbA1c|baseline to 3 months|Of the 50 enrolled in the Use of DRMS group, only 46 completed the visit at 3 months, and out of 48 enrolled in the Usual Care group only 45 completed the visit at 3 months. Therefore only those who completed the visit at 3 months were included in this analysis.||Percent||Standard Deviation|Mean
698602|NCT01354015|Primary|Change in HbA1c|change in A1c from baseline in intervention and control groups|baseline to 6 months|Of the 50 enrolled in the Use of DRMS group, only 44 completed the visit at 6 months, and out of 48 enrolled in the Usual Care group only 43 completed the visit at 6 months. Therefore only those who completed the visit at 6 months were included in this analysis.||Percent||Standard Deviation|Mean
698603|NCT01353976|Secondary|Mycological Cure|Mycological Cure defined as negative KOH and negative culture at Day 43.|Day 43|MITT||Participants|||Number
698604|NCT01353976|Secondary|Effective Treatment|Effective Treatment defined as negative KOH, negative fungal culture, no or mild (a score of 0 or 1) erythema and/or scaling with all other signs or symptoms being absent (score = 0) at Day 43.|Day 43|MITT||Participants|||Number
698612|NCT01353963|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs), or Discontinuation Due to Adverse Events (AEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug with regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between Week 4 and up to Week 8 that were absent before treatment or that worsened relative to pretreatment state.|Week 4 to Week 8|Safety population included all participants who received at least 1 dose of study medication during the observation period.||Participants|||Number
698613|NCT01353911|Secondary|Percentage of Participants Achieving Undetectable HCV RNA at Week 72|Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. Undetectable HCV RNA (target not detected [TND]) was defined as below the 9.3 IU/ml limit of detection. 95% confidence intervals provided based on the Clopper-Pearson method.|Week 72|FAS; all randomized/enrolled participants who received ≥1 dose of study treatment. A Missing = Failure approach was used for missing data. Results for participants who received grazoprevir 400 or 800 mg and were then down-dosed to receive grazoprevir 100 mg are reported separately from participants who completed the 400 mg and 800 mg regimens.||percentage of participants||95% Confidence Interval|Number
698614|NCT01353911|Secondary|Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After the End of Study Therapy (SVR24)|Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL (in plasma). SVR24 was defined as undetectable (TND) HCV RNA at 24 weeks after the end of all study therapy. 95% confidence intervals provided based on the Clopper-Pearson method.|24 weeks after the end of all treatment (up to 72 weeks)|FAS; all randomized/enrolled participants who received ≥1 dose of study treatment. A Missing = Failure approach was used for missing data. Results for participants who received grazoprevir 400 or 800 mg and were then down-dosed to receive grazoprevir 100 mg are reported separately from participants who completed the 400 mg and 800 mg regimens.||percentage of participants||95% Confidence Interval|Number
698615|NCT01353911|Secondary|Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After the End of Study Therapy (SVR12)|Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL (in plasma). SVR12 was defined as undetectable (TND) HCV RNA at 12 weeks after the end of all study therapy. 95% confidence intervals provided based on the Clopper-Pearson method.|12 weeks after the end of all treatment (up to 60 weeks)|FAS; all randomized/enrolled participants who received ≥1 dose of study treatment. A Missing = Failure approach was used for missing data. Results for participants who received grazoprevir 400 or 800 mg and were then down-dosed to receive grazoprevir 100 mg are reported separately from participants who completed the 400 mg and 800 mg regimens.||percentage of participants||95% Confidence Interval|Number
698616|NCT01353911|Secondary|Percentage of Participants Achieving Rapid Viral Response (RVR)|Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL (in plasma). RVR was defined as undetectable (TND) HCV RNA at Week 4 of study therapy. 95% confidence intervals provided based on the Clopper-Pearson method.|After 4 weeks of treatment with grazoprevir/boceprevir|FAS; all randomized/enrolled participants who received ≥1 dose of study treatment. A Missing = Failure approach was used for missing data. Results for participants who received grazoprevir 400 or 800 mg and were then down-dosed to receive grazoprevir 100 mg are reported separately from participants who completed the 400 mg and 800 mg regimens.||percentage of participants||95% Confidence Interval|Number
698617|NCT01353911|Secondary|Median Time to First Achievement of Undetectable HCV RNA During Treatment|Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. Undetectable HCV RNA (target not detected [TND]) was defined as below the 9.3 IU/ml limit of detection. Kaplan Meier summary statistics were calculated for each treatment arm.|From first dose of study medication until first achievement of undetectable HCV RNA (up to 48 weeks of treatment)|FAS; all randomized/enrolled participants who received ≥1 dose of study treatment. Results for participants who received grazoprevir 400 or 800 mg and were then down-dosed to receive grazoprevir 100 mg are reported separately from participants who completed the 400 mg and 800 mg regimens. Participants in the FAS not achieving TND were censored.||days||95% Confidence Interval|Median
698618|NCT01353911|Primary|Number of Participants Who Discontinued Study Medication Due to AEs During the Treatment Period and First 14 Follow-up Days|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR’s product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR’s product, was also an AE.|Treatment period plus the first 14 days of follow-up (up to 50 weeks)|APaT population; all randomized/enrolled who received ≥1 dose of study treatment according to treatment actually received. Participants who received grazoprevir 400 or 800 mg and were then down-dosed to receive grazoprevir 100 mg are reported separately from participants who completed the 400 mg and 800 mg regimens.||participants|||Number
698655|NCT01353508|Secondary|Percent Change From Baseline in Brain Natriuretic Peptide (BNP) Biomarker|BNP was analyzed at a central laboratory.|0.5, 1, 2, 4, 6 and 12 hours post dose on day 1; 24 hours post dose on day 2; 0, 4, 6 and 12 hours post dose on day 7|The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis.||Percentage change||95% Confidence Interval|Least Squares Mean
698619|NCT01353911|Primary|Number of Participants Experiencing Adverse Events (AEs) During the Treatment Period and First 14 Follow-up Days|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR’s product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR’s product, was also an AE.|Treatment period plus the first 14 days of follow-up (up to 50 weeks)|All Participants as Treated (APaT) population; all randomized/enrolled who received ≥1 dose of study treatment according to treatment actually received. Participants who received grazoprevir 400 or 800 mg and were then down-dosed to receive grazoprevir 100 mg are reported separately from participants who completed the 400 mg and 800 mg regimens.||participants|||Number
698620|NCT01353911|Primary|Percentage of Participants Achieving Complete Early Viral Response (cEVR)|Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL (in plasma). cEVR was defined as undetectable HCV RNA (target not detected [TND]) at Week 12. 95% confidence intervals provided based on the Clopper-Pearson method.|After 12 weeks of treatment with grazoprevir/boceprevir|FAS; all randomized/enrolled participants who received ≥1 dose of study treatment. A Missing = Failure approach was used for missing data. Results for participants who received grazoprevir 400 or 800 mg and were then down-dosed to receive grazoprevir 100 mg are reported separately from participants who completed the 400 mg and 800 mg regimens.||percentage of participants||95% Confidence Interval|Number
698621|NCT01353898|Primary|Change From Baseline to Day 10 in Plasma Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Due to Treatment With MK-1972 or Placebo|Blood was collected at baseline and on Day 10, and the plasma concentration for HIV-1 RNA was determined using the Abbott RealTime HIV assay.|Baseline and Day 10 (24 hours post-dose)|All participants who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model.||log10 copies/mL||Standard Error|Mean
698622|NCT01353898|Secondary|The Area Under the Curve From 0-24 Hours (AUC0-24hrs) on Day 10 for Plasma Concentration of MK-1972 in Participants With HIV-1 Infection|Plasma concentration of MK-1972 was determined from blood collected from HIV-1 infected participants on Day 10 : pre-dose up to 24 hours post-dose in order to determine the AUC0-24hrs.|Day 10: pre-dose, and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post-dose|All participants who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. MK-1972 was not measured for the placebo group since it did not receive any of this drug.||nM.hr||Geometric Coefficient of Variation|Geometric Mean
698623|NCT01353898|Primary|Number of Participants Experiencing Clinical and Laboratory Adverse Events (AEs)|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR’s product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR’s product, is also an adverse event.|From consent to 14 days after the last dose (up to Day 24)|All participants who received at least one dose of the investigational drug, according to the treatment they actually received.||Participants|||Number
698624|NCT01353859|Secondary|C-Reactive Protein Levels|CRP levels were measured in milligrams/liter (mg/L) and were used to determine the acute phase response. A reduction in CRP levels is considered an improvement; normal reference range ≤10 mg/L.|Baseline, Weeks 4, 8, 12,16, 20, and 24|ITT Population||mg/L||Standard Deviation|Mean
698625|NCT01353859|Secondary|Erythrocyte Sedimentation Rate|Erythrocyte Sedimentation rate was measured in mm/hour and was used to determine the acute phase response. Lower ESR values indicate reduction in disease activity; normal reference range: 0-20 mm/hr.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT Population||mm/hr||Standard Deviation|Mean
698626|NCT01353859|Secondary|Percentage of Participants Achieving American College of Rheumatology (ACR) 20%, 50%, and 70% Improvement (ACR20, ACR50, or ACR70) Response|ACR20/50/70 response was defined as ≥20%, ≥50%, or ≥70% improvement, respectively, in swollen/tender joint count (66 joints assessed for swelling and 68 joints assessed for tenderness) as well as improvement in at least 3 of the 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the health assessment questionnaire [HAQ]); and acute phase response: C-reactive protein (CRP) or ESR.|Week 24|ITT Population||percentage of participants|||Number
698627|NCT01353859|Secondary|Percentage of Participants With DAS28 <3.2 by Visit|DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hour) and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. DAS28 ≤3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|Baseline and Weeks 4, 8, 12, 16, 20, and 24|ITT Population||percentage of participants|||Number
698628|NCT01353859|Secondary|Time to Achieve DAS28 Remission (DAS28 <2.6)|DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hour) and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. DAS28 remission was defined as DAS28 <2.6. Time to achieve remission was calculated in weeks as the time from the date of first infusion to the date of first achieving remission.|Weeks 4, 8, 12, 16, 20 and 24|ITT Population||weeks||Standard Deviation|Mean
698629|NCT01353859|Secondary|Percentage of Participants Achieving DAS28 Remission (DAS28 <2.6)|DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hour) and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. Remission was defined as DAS28 <2.6.|Baseline and Weeks 4, 8, 12, 16, 20, and 24|ITT Population||percentage of participants|||Number
699129|NCT01348139|Secondary|Emax: Maximum Value of Pulse for Every Treatment Visits|Peak effect (Emax) within 0-4 hours of pulse, for treatment visits 2 to 7.|0 - 4 hrs.|PD analysis set||Beats/min||Standard Deviation|Mean
698630|NCT01353859|Secondary|Time to Clinically Significant Improvement in DAS28|DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hour) and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity; a clinically significant improvement is a reduction in DAS28 score of at least 1.2 units. Time to clinically significant improvement was determined in weeks from the date of first infusion to the date of first achievement of reduction of 1.2 units in DAS28.|Weeks 4, 8, 12, 16, 20 and 24|ITT Population||weeks||Standard Deviation|Mean
698631|NCT01353859|Secondary|Percentage of Participants With a Clinically Significant Improvement in DAS28 Score|DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hour) and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity; a clinically significant improvement in DAS28 score was defined as a reduction of at least 1.2 units.|Weeks 4, 8, 12, 16, 20 and 24|ITT Population||percentage of participants|||Number
698632|NCT01353859|Secondary|Time to Achieve Low Disease Activity (DAS28 ≤3.2)|DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hour) and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. DAS28 ≤3.2 = low disease activity; time to low disease activity was calculated as the time in weeks from the date of first infusion to the first achievement of DAS28 ≤3.2|Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24|ITT Population||weeks||Standard Deviation|Mean
698633|NCT01353859|Primary|Percentage of Participants Achieving Low Disease Activity Score|Disease Activity Score using 28-Joint Count (DAS28) was calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and global health assessment (participant-rated global assessment of disease activity using 10-mm visual analog scale [VAS]); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. DAS28 less than or equal to (≤3.2) equals (=) low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity.|Week 24|ITT population: All participants randomized in the study who received administration of at least one dose of the study drug and who had the last week 24 assessment performed.||percentage of participants|||Number
698634|NCT01353664|Primary|Summary of Participants With Treatment Emergent Adverse Events (TEAEs)|An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. Adverse events were assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4: On the following is the scale: Grade 1 = Mild AE, Grade 2 = Moderate AE, Grade 3 = Severe and Undesirable AE, Grade 4 = Life-threatening or Disabling AE, and Grade 5 = Death. Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention. A TEAE is defined as any AE occurring or worsening on or after the first dose of study drug and within 28 days after the last dose of study drug.|All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug; maximum drug exposure was 231 days|Safety Population = Participants who received at least one dose of study drug.||Participants|||Number
698635|NCT01353586|Secondary|Subpopulation Neurological Assessments (SNA) Endpoint 2 - Incidence of New Neurological Findings Post Ablation|All SNA subjects were to be evaluated by expert neurologists for existing neurological deficits prior to ablation procedure. After procedure, those subjects were also to be assessed for new neurological deficits.|48 hours post-ablation|Neurological assessment subpopulation. This population includes 19 subjects from the nMARQ main study and 17 subjects from the Thermocool control group.||percentage of participants|||Number
698636|NCT01353586|Secondary|Subpopulation Neurological Assessments (SNA) Endpoint 1 - Incidence of Cerebral Embolic (ACE) Lesions Post Ablation|Evaluation of post-ablation generation incidence of asymptomatic cerebral microembolic lesions post ablation, as documented by MRI. All microembolic lesions reported in this study are asymptomatic.|48 hours post-ablation|Neurological assessment subpopulation. This population includes 19 subjects from the nMARQ main study and 17 subjects from the Thermocool control group.||percentage of subjects with ACE Lesion|||Number
698637|NCT01353586|Secondary|Absence of Documented Symptomatic PAF Through 6 Months and 12 Months Post Procedure|This endpoint is defined as the absence of documented symptomatic PAF recurrence through 6 months and 12 months post index ablation procedure.|6 and12 months post study procedure|This analysis population is the effectiveness cohort, excluding 2 subjects who withdrew consent prior to Day 91. The effectiveness cohort includes those who received treatment with the investigational device; but does not include 20 workflow and 22 roll-in subjects.||percentage of participants||95% Confidence Interval|Number
698638|NCT01353586|Secondary|Incidence of Completion of Ablation Procedure|This secondary outcome describes the acute effectiveness, which is defined as pulmonary vein isolation (PVI) documented by confirmed entrance block (with or without the use of a focal catheter).|From 7 days to 12 months post study procedure|Safety population excluding one subject without source document at site||percentage of participants||95% Confidence Interval|Number
698639|NCT01353586|Secondary|Assessment of Pulmonary Vein (PV) Narrowing and Stenosis at 3 Months After Index Ablation|Incidence of narrowing of PV and stenosis at 3 months post ablation, for subjects with available CT/MRA scans at 3 months. PV Stenosis is defined as 70% or more PV diameter reduction.|Three months after index ablation|Subjects in safety analysis group who also had CT/MRI PV scan available at the 3-month post-ablation interval (144 of 160 subjects)||percentage of participants with CT/MRI|||Number
698640|NCT01353586|Secondary|Incidence of Non-Primary Serious Adverse Events (SAEs) up to 12 Months|This secondary safety endpoint includes non-primary serious adverse events within 7 days post-procedure and serious adverse events from 7 days to 12 months post-procedure.|12 months post study procedure|Safety population||percentage of participants|||Number
698891|NCT01350973|Secondary|Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis||12 Weeks|Safety Analysis Set included all participants who received at least one dose of the investigational product.||participants|||Number
698641|NCT01353586|Primary|Incidence of Freedom From Documented Symptomatic Atrial Fibrillation|The primary effectiveness endpoint is freedom from documented symptomatic atrial fibrillation based on electrocardiographic data through 8 months post ablation.|Evaluated from Day 91 to Day 240|Effectiveness cohort: This population excludes those subjects who never underwent insertion of study catheter, those who terminated procedure prior to ablation, and those who were enrolled during the Workflow phase (20 subjects) and Roll-in phase (22 subjects). This analysis also excludes two subjects who withdrew consent post ablation.||percentage of participants||95% Confidence Interval|Number
698642|NCT01353586|Primary|The Incidence of Early Onset Primary Adverse Events|The primary safety endpoint is the incidence of early onset primary adverse events within 7 days of the mapping and ablation procedure. Primary adverse events include pericardial effusion requiring intervention, atrial perforation, pericarditis requiring intervention, cardiac tamponade, pneumothorax, death, pulmonary edema, diaphragmatic paralysis, heart block, stroke / cerebrovascular accident (CVA), hospitalization (initial and prolonged), thromboembolism, myocardial infarction (MI), transient ischemic attack (TIA), and vascular access complications. In addition, pulmonary vein stenosis and atrio-esophageal fistula that occurs greater than one week (7 days) post-procedure are deemed primary adverse event.|Any of above events occurring within 7 days post-procedure (also including the incidence of pulmonary vein stenosis and atrio-esophageal fistula occurring > 7 days and up to one year post-procedure)|Safety Population as defined above||percentage of participants||95% Confidence Interval|Number
698643|NCT01353508|Secondary|Supine Pulse Rate|Pulse rate measurements were taken.|0, 0.5, 1, 2, 4, 8 and 12 hours post dose on day 1; day 2; 0, 0.5, 1, 2, 4, 8 and 12 hours post dose on day 7|The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis.||BPM||Standard Deviation|Mean
698644|NCT01353508|Secondary|Supine Diastolic Blood Pressure|Diastolic blood pressure measurements were taken.|0, 0.5, 1, 2, 4, 8 and 12 hours post dose on day 1; day 2; 0, 0.5, 1, 2, 4, 8 and 12 hours post dose on day 7|The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis.||mmHg||Standard Deviation|Mean
698645|NCT01353508|Secondary|Supine Systolic Blood Pressure|Systolic blood pressure measurements were taken.|0, 0.5, 1, 2, 4, 8 and 12 hours post dose on day 1; day 2; 0, 0.5, 1, 2, 4, 8 and 12 hours post dose on day 7|The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis.||mmHg||Standard Deviation|Mean
698646|NCT01353508|Secondary|Renal Blood Flow (RBF) Over Time|RBF was used as a measure of renal function.|0, 2, 4 and 6 hours post dose on day 1; 0, 2, 4 and 6 hours post dose on day 7|The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis.||mL/min||Standard Deviation|Mean
698647|NCT01353508|Secondary|Glomerular Filtration Rate (GFR) Over Time|GFR was used as a measure of renal function.|0, 2, 4 and 6 hours post dose on day 1; 0, 2, 4 and 6 hours post dose on day 7|The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis.||mL/min||Standard Deviation|Mean
698648|NCT01353508|Secondary|Percent Change From Baseline in Blood Plasma Creatinine|Blood plasma creatinine was analyzed at a central laboratory.|4, 6 and 12 hours post dose on day 1; 24 hours post dose on day 2; 0, 4, 6 and 12 hours post dose on day 7|The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis.||Percentage change||95% Confidence Interval|Least Squares Mean
698649|NCT01353508|Secondary|Percent Change From Baseline in Urinary Electrolyte Excretion (Sodium, Potassium, Chloride and Calcium)|Urine was collected in 12-hour intervals, and of each pooled 24-hour (daily) sample, sodium, potassium, albumin and calcium were measured.|2, 4, 6 and 12 hours post dose on day 1; 24 hours post dose on day 2; 0, 4, 6 and 12 hours post dose on day 7|The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis.||Percentage change||95% Confidence Interval|Least Squares Mean
698650|NCT01353508|Secondary|Percent Change From Baseline in Aldosterone Biomarker|Aldosterone was analyzed at a central laboratory.|6 and 12 hours post dose on day 1; 24 hours post dose on day 2; 0, 6 and 12 hours post dose on day 7|The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis.||Percentage change||95% Confidence Interval|Least Squares Mean
698651|NCT01353508|Secondary|Percent Change From Baseline in N-terminal-proBNP (NT-proBNP) Biomarker|NT-proBNP was analyzed at a central laboratory.|2, 4, 6 and 12 hours post dose on day 1; 24 hours post dose on day 2; 0, 4, 6 and 12 hours post dose on day 7|The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis.||Percentage change||95% Confidence Interval|Least Squares Mean
698652|NCT01353508|Secondary|Percent Change From Baseline in C-terminal-proendothelin-1 (CT-proET-1) Biomarker|CT-proET-1 was analyzed at a central laboratory.|12 hours post dose on day 1; 24 hours post dose on day 2; 0 and 12 hours post dose on day 7|The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis.||Percentage change||95% Confidence Interval|Least Squares Mean
698653|NCT01353508|Secondary|Percent Change From Baseline in C-type Natriuretic Peptide (proCNP) Biomarker|ProCNP was analyzed at a central laboratory.|2, 4, 6, 8 and 12 hours post dose on day 1; day 2; 0, 4, 6, 8 and 12 hours post dose on day 7|The HF arms only of the Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis. MR-proADM is considered a biomarker for HF only; therefore, the HTN cohort was not assessed.||Percentage change||95% Confidence Interval|Least Squares Mean
698654|NCT01353508|Secondary|Percent Change From Baseline in Mid-regional Pro-adrenomedullin (MR-proADM) Biomarker|MR-proADM was analyzed at a central laboratory.|2, 4, 6 and 12 hours post dose on day 1; 24 hours post dose on day 2; 0, 4, 6 and 12 hours post dose on day 7|The HF arms only of the Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis. MR-proADM is considered a biomarker for HF only; therefore, the HTN cohort was not assessed.||Percentage change||95% Confidence Interval|Least Squares Mean
735576|NCT00436566|Secondary|Adverse Event Profile as Measured by NCI CTCAE v 3.0|Maximum grade for each type of adverse event will be recorded for each patient.|5 years||||||
698656|NCT01353508|Secondary|Percent Change From Baseline in Plasma Mid-regional Pro-atrial Natriuretic Peptide (MR-proANP) Biomarker|MR-proANP was analyzed at a central laboratory.|2, 4, 6 and 12 hours post dose on day 1; 24 hours post dose on day 2; 2, 4, 6 and 12 hours post dose on day 7|The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis.||Percentage change||95% Confidence Interval|Least Squares Mean
698657|NCT01353508|Secondary|Urinary Cyclic Guanosine Monophosphate (cGMP) Excretion Over 24 Hours|cGMP was analyzed at a central laboratory. The measure type used for this OM was Geometric LSM.|day 1, day 6, day 7|The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis.||nmol/24 hours||95% Confidence Interval|Least Squares Mean
698658|NCT01353508|Secondary|7-day Cumulative Diuresis|Urine was collected in 12-hour intervals, and of each pooled 24-hour (daily) sample, urine volume was measured. The measure type used for this OM was Geometric LSM.|7-day cumulative (days 1 through 7)|The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis.||mL||95% Confidence Interval|Least Squares Mean
698659|NCT01353508|Secondary|24-hour Diuresis|Urine was collected in 12-hour intervals, and of each pooled 24-hour (daily) sample, urine volume was measured. The measure type used for this OM was Geometric LSM.|day 1|The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis.||mL/24 hours||95% Confidence Interval|Least Squares Mean
698660|NCT01353508|Primary|Cumulative 7-day Urinary Sodium Excretion|Urine was collected in 12-hour intervals, and of each pooled 24-hour (daily) sample, sodium concentration was measured. The measure type used for this outcome measure (OM) was Geometric Least square Means (LSM).|7 day-cummulative (days 1 through 7)|The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis.||mmol/7 days||95% Confidence Interval|Least Squares Mean
698661|NCT01353508|Primary|24-hour Urinary Sodium Excretion|Urine was collected in 12-hour intervals, and of each pooled 24-hour (daily) sample, sodium concentration was measured. The measure type used for this outcome measure (OM) was Geometric Least square Means (LSM).|day 1|The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis.||mmol/24 hours||95% Confidence Interval|Least Squares Mean
698662|NCT01353274|Secondary|Proportion of Patients Who Normalised Their BP|Proportion of patients who normalised their BP after 1, 2, 3, 6, 12 months|after 1, 2, 3, 6, 12 months|Efficacy set: all patients in the safety set who were labelled by T40/A5 mg FDC and have analysable BP data at baseline and at least one post-baseline time point. Missing data were imputed using the Last Observation Carried Forward (LOCF) method.||Percentage of patients (normalised BP)|||Number
698663|NCT01353274|Secondary|Proportion of Patients Who Achieved the Target BP|Proportion of patients who achieved the target BP after 1, 2, 3, 6, 12 months|after 1, 2, 3, 6, 12 months|Efficacy set: all patients in the safety set who were labelled by T40/A5 mg FDC and have analysable BP data at baseline and at least one post-baseline time point. Missing data were imputed using the Last Observation Carried Forward (LOCF) method.||Percentage of patients (target BP)|||Number
698664|NCT01353274|Secondary|Change From Baseline in Diastolic Blood Pressure (DBP)|Change from baseline in DBP after 1, 2, 3, 6, 12 months|after 1, 2, 3, 6, 12 months|Efficacy set: all patients in the safety set who were labelled by T40/A5 mg FDC and have analysable BP data at baseline and at least one post-baseline time point. Missing data were imputed using the Last Observation Carried Forward (LOCF) method.||mmHg||Standard Deviation|Mean
698665|NCT01353274|Secondary|Change From Baseline in Systolic Blood Pressure (SBP)|Change from baseline in SBP after 1, 2, 3, 6, 12 months|after 1, 2, 3, 6, 12 months|Efficacy set: all patients in the safety set who were labelled by T40/A5 mg Fixed Dose Combination (FDC) and have analysable BP data at baseline and at least one post-baseline time point. Missing data were imputed using the Last Observation Carried Forward (LOCF) method.||mmHg||Standard Deviation|Mean
698666|NCT01353274|Primary|Incidence of Drug-related Adverse Events|Number of patients with drug-related adverse events|12 months|Safety set: all patients who were documented to have taken at least one dose of T40/A5 mg FDC except for patients who had no observation documented after entry, made invalid registration or were not under the appropriate site contact||participants|||Number
698667|NCT01353222|Primary|Overall Survival|"Overall survival is defined as the time from randomization to death due to any cause.
*This study was terminated early due to administrative reasons."|Subjects will be followed from baseline through the remainder of their lives or until study completion (approximately 60 months)|"Intent to Treat (ITT) population.
*This study was terminated early due to administrative reasons."||Months||Full Range|Median
698668|NCT01353144|Secondary|Number of Participants Deveoping Peptic Ulcer Bleeding|Number of participants deveoping peptic ulcer bleeding during 8-week study period|8 weeks|||participants|||Number
698669|NCT01353144|Primary|Number of Participants in Whom Peptic Ulcer Was Healed|Number of participants in whom peptic ulcer was healed at week 8|8 weeks|||participants|||Number
698670|NCT01353079|Secondary|Scores on a Scale (Average Daily Rhinoconjunctivitis Symptom Scores During the Three Peak Weeks of Ragweed Pollen Season)|"Change from baseline in avg daily rhinoconjunctivitis symptom scores during the three peak weeks of ragweed pollen season for the ITT population (netpRSS).
Symptom score: sum of scores from 8 symptoms rated 0-3 (0=absent, 1=mild, 2=moderate, 3=severe), ocular (itchiness, swelling/redness, and watery eyes/tears), nasal (sneezing, itching, runny and stuffy nose), and ears (itching). Avg daily RSS Total Score Range: 0 (min) - 48 (max); lower score was more favorable. Avg daily RSS computed by: (1) summing 8 individual allergy symptoms recorded in AM and PM; (2) forming daily RSS by summing AM and PM RSS for each day of ragweed season; (3) averaging daily RSS for three peak weeks of ragweed pollen season."|3 peak weeks of the 2011 ragweed pollen season|ITT population includes subjects who had at least one post treatment efficacy measurement. This analysis includes subjects the met the ITT criteria excluding those subjects that did not have either a combined symptom/medication score or RSS during the three peak weeks of the ragweed pollen season.||Scores on a scale||Standard Deviation|Least Squares Mean
698892|NCT01350973|Secondary|Number of Participants With TEAEs Associated With Abnormal Changes in Vital Signs||12 Weeks|Safety Analysis Set included all participants who received at least one dose of the investigational product.||participants|||Number
698671|NCT01353079|Secondary|Scores of a Scale (Average Daily Rhinoconjunctivitis Symptom Scores During the Entire Ragweed Pollen Season)|Change in baseline in avg daily RSS during entire ragweed season in ITT population. Symptom score: sum of scores from 8 symptoms rated 0-3 (0=absent, 1=mild, 2=moderate, 3=severe), ocular (itchiness, swelling/redness, and watery eyes/tears), nasal (sneezing, itching, runny and stuffy nose), and ears (itching). Avg daily RSS Total Score Range: 0 (min) - 48 (max); lower score was more favorable. Avg daily RSS computed by: (1) summing 8 individual allergy symptoms recorded in AM and PM; (2) forming daily RSS by summing AM and PM RSS for each day of ragweed season; (3) averaging daily RSS for entire ragweed season.|2011 ragweed pollen season; 8/2011 - 10/2011|ITT population includes subjects who had at least one post treatment efficacy measurement||Scores on a scale||Standard Deviation|Least Squares Mean
698672|NCT01353079|Secondary|Scores on a Scale (Net Average Combined Daily Rhinoconjunctivitis Symptom and Medication Scores Reported During the Three Peak Weeks of Ragweed Pollen Season)|Symptom score: sum of scores from 8 symptoms rated 0-3 (0=absent, 1=mild, 2=moderate, 3=severe), ocular (itchiness, swelling/redness, watery eyes/tears), nasal (sneezing, itching, runny, stuffy nose), and ears (itching). Avg daily RSS computed by summing 8 individual allergy symptoms recorded in AM and PM; forming daily RSS by summing AM and PM RSS for each day; averaging daily RSS for three peak weeks. Total allergy relief medication score computed by summing individual medication scores. Relief medication scores: 0-no medication taken; 1-using once daily oral antihistamine; 1-using once daily ocular antihistamine; 1-treatment with albuterol. Max medication score dependent on cumulative rescue medication use. Lower result, more favorable. Three peak weeks of ragweed pollen counts during entire ragweed season was contiguous and calculated using a moving average of ragweed pollen counts for each week. Avg daily Combined Score Range: 0 (min) - 51 (max); lower score was more favorable.|3 peak weeks of the 2011 ragweed pollen season|ITT population includes subjects who had at least one post treatment efficacy measurement. This analysis includes subjects the met the ITT criteria excluding those subjects that did not have either a combined symptom/medication score or RSS during the three peak weeks of the ragweed pollen season.||Scores on a scale||Standard Deviation|Least Squares Mean
698673|NCT01353079|Primary|Scores on a Scale [Net Average Combined Daily Rhinoconjunctivitis Symptom (RSS) and Medication Scores]|Change in baseline in avg combined daily RSS and medication scores during entire ragweed season in ITT population. Symptom score: sum of scores from 8 symptoms rated 0-3 (0=absent, 1=mild, 2=moderate, 3=severe), ocular (itchiness, swelling/redness, and watery eyes/tears), nasal (sneezing, itching, runny and stuffy nose), and ears (itching). Avg daily RSS computed by: (1) summing 8 individual allergy symptoms recorded in AM and PM; (2) forming daily RSS by summing AM and PM RSS for each day of ragweed season; (3) averaging daily RSS for entire ragweed season.Total allergy relief medication score computed by summing individual medication scores. Relief medication scores: 0-no medication taken; 1-using once daily oral antihistamine; 1-using once daily ocular antihistamine; 1-treatment with albuterol. Maximum medication score dependent on cumulative rescue medication use. Lower result is more favorable. Avg daily Combined Score Range: 0 (min) - 51 (max); lower score was more favorable.|2011 ragweed pollen season, 8/2011 -10/2011|ITT population includes subjects who had at least one post treatment efficacy measurement||Scores on a scale||Standard Deviation|Least Squares Mean
698674|NCT01352845|Secondary|Percentage of Participants Achieving at Least a 2-Fold Increase in hSBA Titer for 4 Primary Test Strains Before First Vaccination to 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1||One month after third bivalent rLP2086 vaccination|Evaluable immunogenicity population. Here, N signifies participants with valid and determinate hSBA titers for the given strain at the specified time point. This outcome measure was planned to be analyzed for Group 1 only.||Percentage of participants||95% Confidence Interval|Number
698675|NCT01352845|Secondary|Percentage of Participants Achieving at Least a 3-Fold Increase in hSBA Titer for 4 Primary Test Strains Before First Vaccination to 1 Month After Third Bivalent rLP2086 Vaccination||One month after third bivalent rLP2086 vaccination|Data was not reported because 3-fold rise analyses was not performed as per change in planned analysis.|||||
698676|NCT01352845|Secondary|hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1||Before Vaccination (Vac) 1, 1 Month after Vac 2, 3|Evaluable immunogenicity population. Here, N signifies participants with valid and determinate hSBA titers for the given strain at the specified time point. This outcome measure was planned to be analyzed for Group 1 only.||Titer||95% Confidence Interval|Geometric Mean
698677|NCT01352845|Secondary|Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1|Results for PMB80[A22] 1:16, PMB2001[A56] 1:8, PMB2948[B24] 1:8 and PMB2707[B44] 1:8 are reported under secondary endpoint ‘Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1’.|Before Vaccination (Vac) 1, 1 Month after Vac 2, 3|Evaluable immunogenicity population. Here, N signifies participants with valid and determinate hSBA titers for the given strain at the specified time point. This outcome measure was planned to be analyzed for Group 1 only.||Percentage of participants||95% Confidence Interval|Number
698678|NCT01352845|Secondary|Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1||Before Vaccination (Vac) 1, 1 Month after Vac 2, 3|Evaluable immunogenicity population. Here, N signifies participants with valid and determinate hSBA titers for the given strain at the specified time point. This outcome measure was planned to be analyzed for Group 1 only.||Percentage of participants||95% Confidence Interval|Number
698679|NCT01352845|Secondary|Percentage of Participants Achieving at Least a 4-Fold Increase in hSBA Titer for Each of the 4 Primary Strains Before First Vaccination to 1 Month After the Second Bivalent rLP2086 Vaccination: Group 1||One month after second Bivalent rLP2086 vaccination|Evaluable immunogenicity population. Here, N signifies participants with valid and determinate hSBA titers for the given strain at both the specified time point. This outcome measure was planned to be analyzed for Group 1 only.||Percentage of participants||95% Confidence Interval|Number
698694|NCT01352845|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After First Vaccination||Within 30 days after first vaccination|Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or saline) and for whom safety information was available from first vaccination until prior to second vaccination.||Percentage of participants||95% Confidence Interval|Number
698680|NCT01352845|Secondary|Percentage of Participants Achieving Composite hSBA Titer >=Lower Limit of Quantitation for All 4 Primary Strains Before First Vaccination and 1 Month After Second Bivalent rLP2086 Vaccination: Group 1||Before vaccination 1, 1 Month after Vaccination 2|Evaluable immunogenicity population. Here, N signifies participants valid and determinate hSBA results on all 4 strains at the given time point. This outcome measure was planned to be analyzed for Group 1 only.||Percentage of participants||95% Confidence Interval|Number
698681|NCT01352845|Secondary|hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1||Before first vaccination, 1 month after third vaccination|Evaluable immunogenicity population. Here, number of participants analyzed signifies participants with valid and determinate hSBA titers for the given strain. Here, N signifies participants with valid and determinate assay results for the given antigen or strain. This outcome measure was planned to be analyzed for Group 1 only.||Titers||95% Confidence Interval|Geometric Mean
698682|NCT01352845|Secondary|Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1||Before first vaccination, 1 month after third vaccination (Vac)|Evaluable immunogenicity population. Here, number of participants analyzed signifies participants with valid and determinate hSBA titers for the given strain. Here, N signifies participants with valid and determinate hSBA titers for the given strain at the specified time point. This outcome measure was planned to be analyzed for Group 1 only.||Percentage of participants||95% Confidence Interval|Number
698683|NCT01352845|Secondary|Percentage of Participants With hSBA Titers >= Lower Limit of Quantification for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination: Group 1||Before first vaccination, 1 month after third vaccination|Evaluable immunogenicity population. Here, number of participants analyzed signifies participants with valid and determinate hSBA titers for the given strain. Here, N signifies participants with valid and determinate hSBA titers for the given strain at the specified time point. This outcome measure was planned to be analyzed for Group 1 only.||Percentage of participants||95% Confidence Interval|Number
698684|NCT01352845|Primary|Number of Days Participants Missed School or Work Due to AE During the Vaccination Phase||From the first vaccination up to 1 month after the third vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or saline) and had safety data available. Here, number of participants analyzed signifies subjects that were evaluable for this outcome measure.||Days||Standard Deviation|Mean
698685|NCT01352845|Primary|Percentage of Participants Reporting at Least 1 Immediate Adverse Event (AE) After Third Vaccination||Within 30 minutes after third vaccination|Safety population for third vaccination included all participants who received the third dose of investigational product (rLP2086 or saline) and for whom safety information was available from third vaccination until post third-vaccination blood draw.||Percentage of participants||95% Confidence Interval|Number
698686|NCT01352845|Primary|Percentage of Participants Reporting at Least 1 Immediate Adverse Event (AE) After Second Vaccination||Within 30 minutes after second vaccination|Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline) and for whom safety information was available from second vaccination until prior to third vaccination.||Percentage of participants||95% Confidence Interval|Number
698687|NCT01352845|Primary|Percentage of Participants Reporting at Least 1 Immediate Adverse Event (AE) After First Vaccination||Within 30 minutes after first vaccination|Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or saline) and for whom safety information was available from first vaccination until prior to second vaccination.||Percentage of participants||95% Confidence Interval|Number
698688|NCT01352845|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Throughout the Study Period||From the first vaccination up to 6 month after the third vaccination the third vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or saline) and had safety data available.||Percentage of participants||95% Confidence Interval|Number
698689|NCT01352845|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Follow-Up Phase||From 1 month after third vaccination up to 6 months after the third vaccination|Safety population: all participants who had at least 1 dose of investigational product (rLP2086 or saline) for whom safety information was available from after post third-vaccination blood draw to 6 months after last study vaccination.||Percentage of participants||95% Confidence Interval|Number
698690|NCT01352845|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Vaccination Phase||From the first vaccination up to 1 month after the third vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or saline) and had safety data available.||Percentage of participants||95% Confidence Interval|Number
698691|NCT01352845|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Any Vaccination||Within 30 days after any vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or saline) and had safety data available.||Percentage of participants||95% Confidence Interval|Number
698692|NCT01352845|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Third Vaccination||Within 30 days after third vaccination|Safety population for third vaccination included all participants who received the third dose of investigational product (rLP2086 or saline) and for whom safety information was available from third vaccination until post third-vaccination blood draw.||Percentage of participants||95% Confidence Interval|Number
698693|NCT01352845|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Second Vaccination||Within 30 days after second vaccination|Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline) and for whom safety information was available from second vaccination until prior to third vaccination.||Percentage of participants||95% Confidence Interval|Number
698893|NCT01350973|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs)||12 Weeks|Safety Analysis Set included all participants who received at least one dose of the investigational product.||participants|||Number
698696|NCT01352845|Primary|Percentage of Participants With at Least 1 Medically Attended AE During the Follow-Up Phase||From 1 month after third vaccination up to 6 months after the third vaccination|Safety population: all participants who had at least 1 dose of investigational product (rLP2086 or saline) for whom safety information was available from after post-vaccination 3 blood draw to 6 months after last study vaccination.||Percentage of participants||95% Confidence Interval|Number
698697|NCT01352845|Primary|Percentage of Participants With at Least 1 Medically Attended AE During the Vaccination Phase||From the first vaccination up to 1 month after the third vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or saline) and had safety data available.||Percentage of participants||95% Confidence Interval|Number
698698|NCT01352845|Primary|Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Any Vaccination||Within 30 days after any vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or saline) and had safety data available.||Percentage of participants||95% Confidence Interval|Number
698699|NCT01352845|Primary|Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Third Vaccination||Within 30 days after third vaccination|Safety population for third vaccination included all participants who received the third dose of investigational product (rLP2086 or saline) and for whom safety information was available from third vaccination until until post third-vaccination blood draw.||Percentage of participants||95% Confidence Interval|Number
698700|NCT01352845|Primary|Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Second Vaccination||Within 30 days after second vaccination|Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline) and for whom safety information was available from second vaccination until prior to third vaccination.||Percentage of participants||95% Confidence Interval|Number
698701|NCT01352845|Primary|Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After First Vaccination||Within 30 days after first vaccination|Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or saline) and for whom safety information was available from first vaccination until prior to second vaccination.||Percentage of participants||95% Confidence Interval|Number
698702|NCT01352845|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Throughout the Study Period||From the first vaccination up to 6 month after the third vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or saline) and had safety data available.||Percentage of participants||95% Confidence Interval|Number
698703|NCT01352845|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Vaccination Phase||From the first vaccination up to 1 month after the third vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or saline) and had safety data available.||Percentage of participants||95% Confidence Interval|Number
698704|NCT01352845|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Follow-up Phase||From 1 month after third vaccination up to 6 months after the third vaccination|Safety population: all participants who had at least 1 dose of investigational product (rLP2086 or saline) for whom safety information was available from after post-vaccination 3 blood draw to 6 months after last study vaccination.||Percentage of participants||95% Confidence Interval|Number
698705|NCT01352845|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Any Vaccination||Within 30 days after any vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or saline) and had safety data available.||Percentage of participants||95% Confidence Interval|Number
698706|NCT01352845|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Third Vaccination||Within 30 days after third vaccination|Safety population for third vaccination included all participants who received the third dose of investigational product (rLP2086 or saline) and for whom safety information was available from third vaccination until post third-vaccination blood draw.||Percentage of participants||95% Confidence Interval|Number
698707|NCT01352845|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Second Vaccination||Within 30 days after second vaccination|Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline) and for whom safety information was available from second vaccination until prior to third vaccination.||Percentage of participants||95% Confidence Interval|Number
698708|NCT01352845|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After First Vaccination||Within 30 days after first vaccination|Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or saline) and for whom safety information was available from first vaccination until prior to second vaccination.||Percentage of participants||95% Confidence Interval|Number
698709|NCT01352845|Primary|Percentage of Participants With at Least 1 Adverse Event (AE) During the Vaccination Phase||From the first vaccination up to 1 month after the third vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or saline) and had safety data available.||Percentage of participants||95% Confidence Interval|Number
698710|NCT01352845|Primary|Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Any Vaccination||Within 30 days after any vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or saline) and had safety data available.||Percentage of participants||95% Confidence Interval|Number
698711|NCT01352845|Primary|Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Third Vaccination||Within 30 days after third vaccination|Safety population for third vaccination included all participants who received the third dose of investigational product (rLP2086 or saline) and for whom safety information was available from third vaccination until post third-vaccination blood draw.||Percentage of participants||95% Confidence Interval|Number
698998|NCT01349920|Primary|Change From Baseline in Regenerating Islet-Derived 3-Alpha (REG3-A) at Week 6|Concentrations of the serum biomarker REG3-A were determined at baseline and at Week 6. The change from baseline was Week 6 minus baseline.|Baseline and Week 6|Participants with measurements for REG3-A at both baseline and at Week 6.||ng/mL||Standard Deviation|Mean
698712|NCT01352845|Primary|Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Second Vaccination||Within 30 days after second vaccination|Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline) and for whom safety information was available from second vaccination until prior to third vaccination.||Percentage of participants||95% Confidence Interval|Number
698713|NCT01352845|Primary|Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After First Vaccination||Within 30 days after first vaccination|Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or saline) and for whom safety information was available from first vaccination until prior to second vaccination.||Percentage of participants||95% Confidence Interval|Number
698714|NCT01352845|Primary|Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination||Within 7 days after third vaccination|Safety population for third vaccination included all participants who received the third dose of investigational product (rLP2086 or saline) and for whom safety information was available from third vaccination until post third-vaccination blood draw. Here, 'N' signifies participants with known values reporting specific characteristic.||Percentage of participants||95% Confidence Interval|Number
698715|NCT01352845|Primary|Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination||Within 7 days after second vaccination|Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline) and for whom safety information was available from second vaccination until prior to third vaccination. Here, 'N' signifies participants with known values reporting specific characteristic.||Percentage of participants||95% Confidence Interval|Number
698716|NCT01352845|Primary|Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination||Within 7 days after first vaccination|Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or saline) and for whom safety information was available from first vaccination until prior to second vaccination. Here, 'N' signifies participants with known values reporting specific characteristic.||Percentage of participants||95% Confidence Interval|Number
698717|NCT01352845|Primary|Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Third Vaccination||Within 7 days after third vaccination|Safety population for third vaccination included all participants who received the third dose of investigational product (rLP2086 or saline) and for whom safety information was available from third vaccination until post third-vaccination blood draw.||Percentage of participants||95% Confidence Interval|Number
698718|NCT01352845|Primary|Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Second Vaccination||Within 7 days after second vaccination|Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline) and for whom safety information was available from second vaccination until prior to third vaccination.||Percentage of participants||95% Confidence Interval|Number
698719|NCT01352845|Primary|Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After First Vaccination||Within 7 days after first vaccination|Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or saline) and for whom safety information was available from first vaccination until prior to second vaccination.||Percentage of participants||95% Confidence Interval|Number
698720|NCT01352845|Primary|Percentage of Participants With Greater Than or Equal to(>=)4 Fold Rise in Serum Bactericidal Assay Using Human Complement(hSBA) for 4 Primary Strains and Composite Response (hSBA>=Lower Limit of Quantification for All 4 Primary Strains Combined):Group 1|Here, N signifies participants with valid and determinate hSBA titers for given strain at specified time point. This outcome measure was planned to be analyzed for Group 1 only.|One month after third bivalent rLP2086 vaccination|Evaluable immunogenicity population: all eligible participants randomized, who received correct investigational product, had pre/post vaccination blood drawn at pre-specified time points, had valid and determinate assay results for proposed analysis, received no prohibited treatment or prohibited vaccines, and had no major protocol violations.||Percentage of participants||95% Confidence Interval|Number
698721|NCT01352793|Secondary|Number of Days Participant Missed School or Work Due to Adverse Events (AEs)||Vaccination 1 up to 1 month after Vaccination 3|Safety population included all participants who received at least 1 dose of the study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available.||days||Full Range|Median
698722|NCT01352793|Secondary|Percentage of Participants With at Least One Immediate Adverse Event (AE) After Each Study Vaccination|An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. Any AE that occurred within the first 30 minutes after the administration of study vaccine (bivalent rLP2086, HAV vaccine or saline) was classified as an immediate AE. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.|Within 30 minutes after Vaccination 1, 2, 3|Safety population included all participants who received at least 1 dose of the study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available.||percentage of participants||95% Confidence Interval|Number
698723|NCT01352793|Secondary|Percentage of Participants With at Least One Adverse Event (AE) During Pre-specified Time Periods|An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.|Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3)|Safety population included all participants who received at least 1 dose of the study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available.||percentage of participants||95% Confidence Interval|Number
698735|NCT01352741|Secondary|Open-label Titration Period: Sleep Evaluation Questionnaire - Overall Quality of Sleep in the Double-blind Comparative Period Population|"The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the overall quality of sleep.
The participant rated this categorically as being one of the following: excellent, good, fair or poor."|Baseline Visit (Day 1)|Double-Blind Comparative Population. Per Protocol Set (PPS).||participants|||Number
735577|NCT00436566|Primary|Number of Patients With Congestive Heart Failure (CHF) While on Active Treatment||6 months|||participants|||Number
698724|NCT01352793|Secondary|Percentage of Participants With at Least One Newly Diagnosed Chronic Medical Condition During Pre-specified Time Periods|A newly diagnosed chronic medical condition was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects. Newly diagnosed chronic medical condition did not include illnesses considered to be temporary conditions. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.|Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase(Vaccination 1 up to 1 month after Vaccination 3); follow-up phase(1 month up to 6 months after Vaccination 3); throughout study(Vaccination 1 up to 6 months after Vaccination 3)|Safety population included all participants who received at least 1 dose of the study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available.||percentage of participants||95% Confidence Interval|Number
698725|NCT01352793|Secondary|Percentage of Participants With at Least One Medically Attended Adverse Event During Pre-specified Time Periods|A medically attended AE was defined as a non-serious AE that required medical attention.|Within 30 days after any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3); follow-up phase (1 month up to 6 months after Vaccination 3); throughout study (Vaccination 1 up to 6 months after Vaccination 3)|Safety population included all participants who received at least 1 dose of the study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available.||percentage of participants||95% Confidence Interval|Number
698726|NCT01352793|Secondary|Percentage of Participants With at Least One Serious Adverse Event (SAE) During Pre-specified Time Periods|An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.|Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3); follow-up phase (1 month up to 6 months after Vaccination 3)|Safety population included all participants who received at least 1 dose of the study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available.||percentage of participants||95% Confidence Interval|Number
698727|NCT01352793|Primary|Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 3|A medically attended AE was defined as a non-serious AE that required medical attention.|Within 30 days after Vaccination 3|Vaccination 3 safety population included all participants who received the third dose of study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available from Vaccination 3 to post Vaccination 3 follow-up visit (1 month after Vaccination 3).||percentage of participants||95% Confidence Interval|Number
698728|NCT01352793|Primary|Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 2|A medically attended AE was defined as a non-serious AE that required medical attention.|Within 30 days after Vaccination 2|Vaccination 2 safety population included all participants who received the second dose of study vaccine (bivalent rLP2086 or saline) and had safety information available from Vaccination 2 until prior to Vaccination 3.||percentage of participants||95% Confidence Interval|Number
698729|NCT01352793|Primary|Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 1|A medically attended AE was defined as a non-serious AE that required medical attention.|Within 30 days after Vaccination 1|Vaccination 1 safety population included all participants who received the first dose of study vaccine (bivalent rLP2086 or HAV vaccine) and had safety information available from Vaccination 1 until prior to Vaccination 2.||percentage of participants||95% Confidence Interval|Number
698730|NCT01352793|Primary|Percentage of Participants With at Least One Serious Adverse Event (SAE) Throughout the Study|An adverse event (AE) was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly.|Vaccination 1 up to 6 months after Vaccination 3|Safety population included all participants who received at least 1 dose of study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available.||percentage of participants||95% Confidence Interval|Number
698731|NCT01352741|Secondary|Double-blind Comparative Period: Subject's Satisfaction With Treatment|"Participants rated their satisfaction with the study drug (IMPs) by answering the following question on a 5-point rating scale:
“How would you rate your overall satisfaction with your current pain treatment?”: Excellent, Very Good, Good, Fair and Poor."|End of Comparative Period at Final Evaluation Visit (Day 77)|Last Observation Carried Forward (LOCF); Per Protocol Set||participants|||Number
698732|NCT01352741|Secondary|Open-label Titration Period: Subject's Satisfaction With Treatment|"Participants rated their satisfaction with the study drug (IMPs) by answering the following question on a 5-point rating scale:
“How would you rate your overall satisfaction with your current pain treatment?”: Excellent, Very Good, Good, Fair and Poor."|End of Open-label Titration Period at Randomization Visit (Day 22)|Last Observation Carried Forward (LOCF); Per Protocol Set||participants|||Number
698733|NCT01352741|Secondary|Double-blind Comparative Period: Change in the Overall Quality of Sleep|"The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the overall quality of sleep.
The improvement, no change or worsening is reported based on the replies scored by the participants given at their End of Continuation Visit."|Randomization Visit (Day 22) to Final Evaluation (Day 77)|Double-Blind Comparative Population. Per Protocol Set (PPS).||participants|||Number
698734|NCT01352741|Secondary|Open-label Titration Period: Sleep Evaluation Questionnaire - Overall Quality of Sleep in the Double-blind Comparative Period Population|"The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the overall quality of sleep.
The participant rated this categorically as being one of the following: excellent, good, fair or poor."|Randomization Visit (Day 22)|Double-Blind Comparative Population. Per Protocol Set (PPS).||participants|||Number
698790|NCT01352585|Secondary|Number of Patients With Platelet Count ≤400x10^9/L After 12 Months|A platelet count of ≤400x10^9/L after 12 months is considered a complete response.|1 year|FAS||participants|||Number
698736|NCT01352741|Secondary|Open-label Titration Period: Sleep Evaluation Questionnaire - Overall Quality of Sleep in the Double-blind Comparative Period Population|"The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the overall quality of sleep.
The participant rated this categorically as being one of the following: excellent, good, fair or poor."|Enrollment Visit (Day-12)|Double-Blind Comparative Population. Per Protocol Set (PPS).||participants|||Number
698737|NCT01352741|Secondary|Open-label Titration Period: Sleep Evaluation Questionnaire – Overall Quality of Sleep|"The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the overall quality of sleep.
The participant rated this categorically as being one of the following: excellent, good, fair or poor."|Enrollment Visit (Day-12); Baseline Visit (Day 1); Randomization Visit (Day 22)|Observed.||participants|||Number
698738|NCT01352741|Secondary|Double-blind Comparative Period: Sleep Evaluation Questionnaire - Change in the Number of Hours Slept|The sleep evaluation questionnaire was completed by the participant. The answer was in response to the question: Sleep evaluation: How long did you sleep last night [hours]? The value reported is the change in the number of hours of sleep from baseline. The positive value indicates that there was an increase in the number of hours of sleep in a treatment group.|Baseline Visit (Day -12); Randomization Visit (Day 1); Final Evaluation Visit (Day 77)|Per Protocol Set.||hours||Standard Deviation|Mean
698739|NCT01352741|Secondary|Open-label Titration Period: Sleep Evaluation Questionnaire - Number of Hours Slept in the Double-blind Comparative Period Population|"The participants were requested to answer the following question:
How long did you sleep last night [hours]? The values were calculated from the data that participants self-reported for the night prior to their Randomization Visit (Baseline) and for the night prior to the End of the Continuation Visit (12 weeks after randomization)."|Enrollment Visit (Day -12); Baseline Visit (Day 1); Randomization Visit (Day 22)|Per Protocol Set (PPS).||hours||Standard Deviation|Mean
698740|NCT01352741|Secondary|Open-label Titration Period: Sleep Evaluation Questionnaire – Time Slept|"The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the number of awakenings.
The participant was asked: How long did you sleep last night? [Answered in hours and minutes]."|Enrollment Visit (Day-12); Baseline Visit (Day 1); Randomization Visit (Day 22)|Observed.||hours||Standard Deviation|Mean
698741|NCT01352741|Secondary|Double-blind Comparative Period: Change in the Number of Awakenings|The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the number of awakenings. Participants were asked: How many times did you wake up during the night? The change in the Number of Awakenings was calculated from the data that participants self-reported for the night prior to their Randomization Visit (Baseline), for the night prior to the Baseline Visit (Day 1) and the night prior to the Final Evaluation Visit (Day 77). A negative change indicates that the number of awakenings in a treatment group have gone down since the Baseline or Randomization Visit. In general pain can interfere with sleep, one potential indicator is the number of awakenings.|Baseline Visit (Day 1); Randomization Visit (Day 22) to Final Evaluation Visit (Day 77)|Per Protocol Set (PPS).||Number of Awakenings||Standard Deviation|Mean
698742|NCT01352741|Secondary|Open-label Titration Period: Sleep Evaluation - Number of Awakenings in the Double-blind Comparative Period Population|"The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the number of awakenings.
How many times did you wake up during the night? The values were calculated from the data that participants self-reported for the night prior to their Randomization Visit (Baseline), for the night prior to the Baseline Visit (Day 1) and the night prior to the Randomization Visit (Day 22).
The participant was asked at each visit: How many times did you wake up during the night?"|Enrollment Visit (Day-12); Baseline Visit (Day 1); Randomization Visit (Day 22)|Double-Blind Comparative Population. Per Protocol Set (PPS).||Number of Awakenings||Standard Deviation|Mean
698743|NCT01352741|Secondary|Open-label Titration Period: Sleep Evaluation Questionnaire – Number of Awakenings|"The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the number of awakenings.
How many times did you wake up during the night? The values were calculated from the data that participants self-reported for the night prior to their Randomization Visit (Baseline), for the night prior to the Baseline Visit (Day 1) and the night prior to the Randomization Visit (Day 22).
The participant was asked at each visit: How many times did you wake up during the night?"|Enrollment Visit (Day-12); Baseline Visit (Day 1); Randomization Visit (Day 22)|Observed.||Number of Awakenings||Standard Deviation|Mean
698744|NCT01352741|Secondary|Double-blind Comparative Period Sleep Evaluation Questionnaire: Change in Latency|The sleep evaluation questionnaire was completed by the participant. The participant was asked: How long after bedtime/lights out did you fall asleep last night [hours]? The values are for the night prior to the visits. The negative change from baseline indicates that the time to falling asleep decreased from baseline in a treatment group.|Baseline Visit (Day 1); Randomization Visit (Day 22) to Final Evaluation Visit (Day 77)|Per Protocol Set (PPS).||hours||Standard Deviation|Mean
698745|NCT01352741|Secondary|Open-label Titration Period: Sleep Evaluation Questionnaire - Latency in the Double-blind Comparative Period Population|The sleep evaluation questionnaire was completed by the participant. The participant was asked: How long after bedtime/lights out did you fall asleep last night [hours]? The values are for the night prior to the Randomization Visit (Baseline) and for the night prior to the Final Evaluation Visit (12 weeks after randomization). The higher the value the longer it took to fall asleep. Sleep evaluation questionnaire (SQ) items|Enrollment Visit (Day -12); Baseline Visit (Day 1); Randomization Visit (Day 22)|Per Protocol Set (PPS).||hours||Standard Deviation|Mean
698746|NCT01352741|Secondary|Open-label Titration Period: Sleep Evaluation Questionnaire – Latency|"The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the sleep latency.
To assess latency the participant was asked: How long after bedtime/lights out did you fall asleep last night [hours]?"|Enrollment Visit (Day-12); Baseline Visit (Day 1); Randomization Visit (Day 22)|Observed.||hours||Standard Deviation|Mean
698895|NCT01350973|Secondary|Percent Change From Baseline in High-Density Lipoprotein - Cholesterol (HDL-C) Level Over Time|The percentage change between high-density lipoprotein cholesterol collected at each study visit relative to Baseline.|Baseline and Weeks 4, 8, 10 and 12|"Full analysis set with available data at each time point (indicated by n)."||percent change||Standard Deviation|Mean
698747|NCT01352741|Secondary|Double-blind Comparative Period: Change in Hospital Anxiety and Depression Scale - Depression in the Double-blind Comparative Period Population|The Hospital Anxiety and Depression Scale (HADS) is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises 14 items. Seven statements describe depression. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points. A score below 7 is not considered to indicate depression. A score of 11 or above is considered to be a case of depression. A decrease in values over time indicates that there has been an improvement. A negative change value indicates a decrease in the depression score since the start of treatment.|Baseline Visit (Day 1); Randomization Visit (Day 22); Final Evaluation Visit (Day 77)|Double-Blind Comparative Population. Per Protocol Set (PPS).||units on a scale||Standard Deviation|Mean
698748|NCT01352741|Secondary|Open-label Titration Period: Hospital Anxiety and Depression Scale - Depression in the Double-blind Comparative Period Population|The Hospital Anxiety and Depression Scale (HADS) is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises 14 items. Seven statements describe depression. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points. A score below 7 is not considered to indicate depression. A score of 11 or above is considered to be a case of depression. A decrease in values over time indicates that there has been an improvement.|Enrollment Visit (Day-12); Baseline Visit (Day 1); Randomization Visit (Day 22)|Double-blind Comparative Population; Per Protocol Set (PPS).||units on a scale||Standard Deviation|Mean
698749|NCT01352741|Secondary|Double-blind Comparative Period: Change in Hospital Anxiety and Depression Scale - Anxiety in the Double-blind Comparative Period Population|"The Hospital Anxiety and Depression Scale (HADS) is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises 14 items. Seven statements describe anxiety. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points. A score below 7 is not considered to indicate anxiety. A score of 11 or above is considered to be a case of anxiety.
A negative sign indicates that there has been a decrease in anxiety since the start of treatment."|Baseline Visit (Day 1); Randomization Visit (Day 22); Final Evaluation Visit (Day 77)|Double-Blind Comparative Population. Per Protocol Set (PPS).||units on a scale||Standard Deviation|Mean
698750|NCT01352741|Secondary|Open-label Titration Period: Hospital Anxiety and Depression Scale - Anxiety in the Double-blind Comparative Period Population|"The Hospital Anxiety and Depression Scale (HADS) is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises 14 items. Seven statements describe anxiety. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points. A score below 7 is not considered to indicate anxiety. A score of 11 or above is considered to be a case of anxiety.
A decrease in values over the trial period indicate that there has been an improvement."|Enrollment Visit (Day-12); Baseline Visit (Day 1); Randomization Visit (Day 22)|Double-Blind Comparative Population. Per Protocol Set (PPS).||units on a scale||Standard Deviation|Mean
698751|NCT01352741|Secondary|Double-blind Comparative Period: Clinician Global Impression of Change (CGIC)|"In the Clinician Global Impression of Change (CGIC) the clinician indicated the perceived change over the treatment period. The clinician was requested to choose one of seven categories for each participant. The Clinician rated the participants change as very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse."|Randomization Visit (Day 22) to Final Evaluation Visit (Day 77)|Double-Blind Comparative Population. Full Analysis Set (FAS).||participants|||Number
698752|NCT01352741|Secondary|Double-blind Comparative Period: Patient Global Impression of Change (PGIC)|"In the Patient Global Impression of Change (PGIC) the participant indicated the perceived change over the treatment period. PGIC is a 7 point scale where the patient's rates overall improvement. Patients rate their change as very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse."|Randomization Visit (Day 22) to Final Evaluation Visit (Day 77)|Double-blind comparative population. Full Analysis Set (FAS).||participants|||Number
698753|NCT01352741|Secondary|Double-blind Comparative Period: Change EuroQol-5 Dimension (EQ-5D) Health Status Index|"The participant scored the EuroQol-5 questionnaire. The EuroQol-5 questionnaire uses a health state classification with 5 dimensions. Each dimension was assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1 (with 1 indicating full health and 0 representing dead). The higher the values (the closer the value is to 1) the better the health status in a treatment group."|Enrollment Visit (Day-12); Baseline Visit (Day 1); Randomization Visit (Day 22)|Double-Blind Comparative Population. Per Protocol Set (PPS).||units on a scale||Standard Deviation|Mean
698754|NCT01352741|Secondary|Open-label Titration Period: EuroQol-5 Dimension (EQ-5D) Health Status Index Score for the Double-blind Comparative Period Population|"The participant scored the EuroQol-5 questionnaire. The EuroQol-5 questionnaire uses a health state classification with 5 dimensions. Each dimension was assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1 (with 1 indicating full health and 0 representing dead). The higher the values (the closer the value is to 1) the better the health status in a treatment group."|Enrollment Visit (day-12); Baseline Visit (Day 1); Randomization Visit (Day 22)|Double-Blind Comparative Population. Per Protocol Set (PPS).||units on a scale||Standard Deviation|Mean
698755|NCT01352741|Secondary|Double-blind Comparative Period: Change in Short Form Health Survey (SF-12) Mental Health Composite Score (MCS)|The Short Form Health Survey (SF-12) has several brief broad questions on 8 aspects of health (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. The mental health summary scores were calculated from the individual responses to two of the 12 questions. A higher score indicates a better participant perceived state of health. All domains were scored on a scale from 0 (lowest level of health) to 100 (highest level of health), with 100 representing the best possible mental health.|Baseline Visit (Day 1); Randomization Visit (Day 22); Final Evaluation Visit (Day 77)|Double-Blind Comparative Population. Per Protocol Set (PPS).||units on a scale||Standard Deviation|Mean
740027|NCT00461734|Secondary|Brain Natriuretic Peptide Levels (Per Protocol Cohort)||At 2-year follow-up|Per Protocol Cohort with data available||picograms per milliliter||Full Range|Median
698756|NCT01352741|Secondary|Open-label Titration Period: Comparative Double-blind Period Population Short Form Health Survey (SF-12) Mental Health Composite Score (MCS)|The Short Form Health Survey (SF-12) has several brief broad questions on 8 aspects of health (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. The mental health summary scores were calculated from the individual responses to two of the 12 questions. A higher score indicates a better participant perceived state of health. All domains were scored on a scale from 0 (lowest level of health) to 100 (highest level of health), with 100 representing the best possible mental health.|Enrollment Visit; Baseline Visit (Day 1); Randomization Visit (Day 22)|Double-Blind Comparative Population. Per Protocol Set (PPS).||units on a scale||Standard Deviation|Mean
698757|NCT01352741|Secondary|Double-blind Comparative Period: Changes in the Short Form Health Survey (SF-12) Physical Health Composite Score (PCS)|"The Short Form Health Survey (SF-12) has several brief broad questions on 8 aspects of health (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. The physical summary scores were calculated from the individual responses to those questions covering physical health. A higher score indicates a better participant perceived state of health. All domains were scored on a scale from 0 (lowest level of health) to 100 (highest level of health), with 100 representing the best possible health state.
The change in the SF-12 score shows an improvement in health from baseline if the values are positive. The higher the value the greater the improvement."|Baseline Visit (Day 1); Randomization Visit (Day 22); Final Evaluation Visit (Day 77)|Double-Blind Comparative Population. Per Protocol Set (PPS).||units on a scale||Standard Deviation|Mean
698758|NCT01352741|Secondary|Open-label Titration Period: Comparative Double-blind Period Population Short Form Health Survey (SF-12) Physical Health Composite Score (PCS)|The Short Form Health Survey (SF-12) has several brief broad questions on 8 aspects of health (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. The physical and mental summary scores were calculated from the individual responses. A higher score indicates a better perceived state of health. All domains were scored on a scale from 0 (lowest level of health) to 100 (highest level of health), with 100 representing the best possible health state.|Enrollment Visit; Baseline Visit (Day 1); Randomization Visit (Day 22)|Double-Blind Comparative Population. Per Protocol Set (PPS).||units on a scale||Standard Deviation|Mean
698759|NCT01352741|Secondary|Double-blind Comparative Period: Change in Neuropathic Pain Symptom Inventory (NPSI) Sub-scores and Overall Score Assessment|In the Neuropathic Pain Symptom Inventory (NPSI) the participant rated their symptoms of neuropathic pain. Ten pain questions were answered on an 11-point scale, from 0 (symptom not present) to 10 (symptom at its worst imaginable intensity, e.g. Spontaneous Pressing Pain Subscore). The overall NPSI score was calculated by the summation of all ten responses and ranges between 0 and 100. For pain descriptions burning, pressing, paroxysmal (pain like electric shocks or stabbing), evoked (due to touch) and paresthesia (sensation that is not unpleasant) or dysesthesia (unpleasant) subscores are reported. The overall values reported for all participants that completed the questionnaire are shown. A symptom was absent if the value is 0, the symptom was present in all participants and all participants rated it at its worst possible intensity if a value is 10 (100 for the overall score) . A negative change indicates that the intensity of the symptom has decreased since the start of treatment.|Randomization Visit (Day 22); Final Evaluation Visit (Day 77)|Double-blind comparative population. Per Protocol Set (PPS).||units on a scale||Standard Deviation|Mean
698760|NCT01352741|Secondary|Open-label Titration Period: Neuropathic Pain Symptom Inventory (NPSI) Overall Score Assessment in the Double-blind Comparative Period Population|In the Neuropathic Pain Symptom Inventory (NPSI) the participant rated their symptoms of neuropathic pain. Ten pain questions were answered on an 11-point scale; from 0 (symptom not present) to 10 (symptom at its worst imaginable intensity, e.g. worst burning imaginable). The overall NPSI score was calculated by the summation of all ten responses and ranges between 0 and 100. For pain descriptions burning, pressing, paroxysmal (pain like electric shocks or stabbing), evoked (due to touch) and paresthesia (sensation that is not unpleasant) or dysesthesia (unpleasant) sub-scores are reported. The overall values reported for all participants that completed the questionnaire are shown. A symptom was absent if the value is 0, the symptom was present in all participants and all participants rated it at its worst possible intensity if a value is 100.|Enrollment Visit; Baseline Visit (Day 1); Randomization Visit (Day 22); Final Evaluation Visit (Day 77)|Double-blind comparative population. Per Protocol Set (PPS).||units on a scale||Standard Deviation|Mean
698761|NCT01352741|Secondary|Open-label Titration Period: Neuropathic Pain Symptom Inventory (NPSI) Overall Score Assessment|In the Neuropathic Pain Symptom Inventory (NPSI) the participant rated their symptoms of neuropathic pain. Ten pain questions were answered on an 11-point scale; from 0 (symptom not present) to 10 (symptom at its worst imaginable intensity, e.g. worst burning imaginable). The overall NPSI score was calculated by the summation of all ten responses and ranges between 0 and 100. For pain descriptions burning, pressing, paroxysmal (pain like electric shocks or stabbing), evoked (due to touch) and paresthesia (sensation that is not unpleasant) or dysesthesia (unpleasant) sub-scores are reported. The overall values reported for all participants that completed the questionnaire are shown. A symptom was absent if the value is 0, the symptom was present in all participants and all participants rated it at its worst possible intensity if a value is 100.|Enrollment Visit; Baseline Visit (Day 1); Randomization Visit (Day 22)|Observed.||units on a scale||Standard Deviation|Mean
698762|NCT01352741|Secondary|Double-blind Comparative Period: Change in painDETECT Final Assessment|"The painDETECT was a participant completed questionnaire. The questionnaire consists of 14 questions in four domains. Based on these questions a final assessment score was calculated. The minimum score ranged from zero to a maximum of 38. Participants with a score between 0 and 12 were scored as being negative (had no neuropathic pain component). A value between 19 and 38 was rated as being positive (neuropathic component present). Values from 13 to 18 were scored as being unclear. The theoretical range of change in this trial ranged from -38 to 19. A negative change indicated a decrease in their neuropathic component of pain."|Baseline Visit (Day 1); Randomization Visit (Day 22); Final Evaluation Visit (Day 77)|Double-blind comparative population. Per Protocol Set (PPS).||units on a scale||Standard Deviation|Mean
699130|NCT01348139|Secondary|E0-24h: The Average of the FEV1 Values Between 0 and 24 h for Every Treatment Visit|Average effect over 0-24 hours of FEV1 (E0-24h), for treatment visits 2 to 7.|0 - 24 hrs|PD analysis set||Liters||Standard Deviation|Mean
698763|NCT01352741|Secondary|Open-label Titration Period: Comparative Double-blind Period Population painDETECT Assessment|"The painDETECT was a participant completed questionnaire. The questionnaire consists of 14 questions in four domains. Based on these questions a final assessment score was calculated. The minimum score ranged from zero to a maximum of 38. Participants with a score between 0 and 12 were scored as being negative (had no neuropathic pain component). A value between 19 and 38 was rated as being positive (neuropathic component present). Values from 13 to 18 were scored as being unclear."|Enrollment Visit (Day-12); Baseline Visit (Day 1); Randomization Visit (Day 22)|Double-blind comparative population. Per Protocol Set (PPS).||units on a scale||Standard Deviation|Mean
698764|NCT01352741|Secondary|Open-label Titration Period: painDETECT Assessments|"The painDETECT was a participant completed questionnaire. The questionnaire consists of 14 questions in four domains. Based on these questions a final assessment score was calculated. The minimum score ranged from zero to a maximum of 38. Participants with a score between 0 and 12 were scored as being negative (had no neuropathic pain component). A value between 19 and 38 was rated as being positive (neuropathic component present). Values from 13 to 18 were scored as being unclear."|Enrollment Visit (Day-12); Baseline Visit (Day 1); Randomization Visit (Day 22)|Observed.||units on a scale||Standard Deviation|Mean
698765|NCT01352741|Secondary|Double-blind Comparative Period: Change in Worst Pain Intensity Over the Past 24 Hours|"The recalled worst pain intensity during the last 24 hours was assessed using an 11-point Numeric rating scale, where 0 = no pain and 10 = pain as bad as you can imagine.
The participant was asked: Please rate your pain intensity by assessing the one number that best describes your worst pain during the last 24 hours prior to the visit.
A negative change indicates that the pain intensity decreased from the start of the trial."|Randomization Visit (Day 22); Final Evaluation Visit (Day 77)|Double-blind comparative population. Per Protocol Set (PPS).||units on a scale||Standard Deviation|Mean
698766|NCT01352741|Secondary|Open-label Titration Period: Comparative Double-blind Period Population Worst Mean Pain Intensity Scores Over the Past 24 Hours|"The recalled worst pain intensity during the last 24 hours was assessed using an 11-point Numeric Rating Scale (NRS), where 0 = no pain and 10 = pain as bad as you can imagine.
The participant was asked : Please rate your pain intensity by assessing the one number that best describes your worst pain during the past 24 hours prior to the visit."|Enrollment Visit (Day-12); Baseline Visit (day 1); Randomization Visit (Day 22)|Double-blind comparative population. Per Protocol Set (PPS)||units on a scale||Standard Deviation|Mean
698767|NCT01352741|Secondary|Open-label Titration Period: Worst Mean Pain Intensity Scores Over the Past 24 Hours|"The recalled worst pain intensity during the last 24 hours was assessed using an 11-point Numeric rating scale, where 0 = no pain and 10 = pain as bad as you can imagine.
The participant was asked: Please rate your pain intensity by assessing the one number that best describes your worst pain during the last 24 hours prior to the visit."|Enrollment Visit (Day -14); Baseline Visit (Day 1); Randomization Visit (Day 22)|Observed.||units on a scale||Standard Deviation|Mean
698768|NCT01352741|Secondary|Double-blind Comparative Period: Change in NRS-3 Pain Intensity Score for the Radiating Pain|"NRS-3 pain intensity score (recalled average pain intensity score during the last 3 days on 11-point NRS, where 0 is the no pain and 10 is pain as bad as you can imagine) for radiating pain (pain radiating into or towards the leg, typically of shooting, radiating character, usually radiating below the knee towards the foot).
The value reported represents the change from the randomization visit (i.e., the last 3 days in the titration period) to the end of the double-blind comparative period (i.e., the last 3 days in the comparative period). The theoretical values range from -10 to 10. A negative sign indicates a decrease in pain from the start of treatment. The higher the absolute values, the greater the change since the start of treatment (baseline visit)."|Randomization Visit (Day 22); End of Evaluation Visit (Day 77)|Double-blind comparative population. Per Protocol Set (PPS).||units on a scale||Standard Deviation|Mean
698769|NCT01352741|Secondary|Open-label Titration Period: Radiating Mean Pain Intensity Score for the Comparative Period Population|The NRS-3 pain intensity score at the visits in the open-label titration period for the two comparative double-blind period treatment groups analyzed is reported. NRS-3 pain intensity score (recalled average pain intensity score during the last 3 days on an 11-point NRS) for radiating pain (pain radiating into or towards the leg, typically of shooting, radiating character, usually radiating below the knee towards the foot) is reported. Where 0 = no pain and 10 indicates pain as bad as you can imagine.|Enrollment Visit (Day -14); Baseline Visit (Day 1); Randomization Visit (Day 22)|Double-Blind Comparative Population. Per Protocol Set (PPS).||units on a scale||Standard Deviation|Mean
698770|NCT01352741|Secondary|Open-label Titration Period: Radiating Pain|The NRS-3 pain intensity score at the visits in the open-label titration period for the two comparative double-blind period treatment groups analyzed is reported. NRS-3 pain intensity score (recalled average pain intensity score during the last 3 days on an 11-point NRS) for radiating pain (pain radiating into or towards the leg, typically of shooting, radiating character, usually radiating below the knee towards the foot) is reported. Where 0 = no pain and 10 indicates pain as bad as you can imagine.|Enrollment Visit (Day -14); Baseline Visit (Day 1); Randomization Visit (Day 22)|Observed.||units on a scale||Standard Deviation|Mean
698771|NCT01352741|Secondary|End of Open-label Pick-up Period: Average Pain Intensity Score for the Overall Low Back Pain on an 11-point Numeric Rating Scale (NRS-3)|The recalled average pain intensity score on the NRS-3 was assessed using an 11-point Numeric Rating Scale (NRS). This scale recalls the average pain intensity during the last 3 days. The participant was asked: “Please rate your pain intensity by assessing the one number that best describes your pain on average during the last 3 days (the last 72 hours prior to the visit)”. Where 0 = no pain and 10 indicates pain as bad as you can imagine.|Final Evaluation Visit (Day 77)|Observed.||units on a scale||Standard Deviation|Mean
698772|NCT01352741|Secondary|Open-label Continuation Period: Average Pain Intensity Score for the Overall Low Back Pain on an 11-point Numeric Rating Scale (NRS-3)|The recalled average pain intensity score on the NRS-3 was assessed using an 11-point Numeric Rating Scale (NRS). This scale recalls the average pain intensity during the last 3 days. The participant was asked: “Please rate your pain intensity by assessing the one number that best describes your pain on average during the last 3 days (the last 72 hours prior to the visit)”. Where 0 = no pain and 10 indicates pain as bad as you can imagine.|Enrollment (Day -14); Baseline Visit (Day 1); Randomization Visit (Day 22); Final Evaluation Visit (Day 77)|Observed values.||units on a scale||Standard Deviation|Mean
740028|NCT00461734|Secondary|Brain Natriuretic Peptide Levels (Intent to Treat Cohort)||At 2-year follow-up|Intent to Treat Cohort with data available||picograms per milliliter||Full Range|Median
698773|NCT01352741|Secondary|Open-label Titration Period: Average Pain Intensity Score for the Overall Low Back Pain on an 11-point Numeric Rating Scale (NRS-3)|The recalled average pain intensity score on the NRS-3 was assessed using an 11-point Numeric Rating Scale (NRS). This scale recalls the average pain intensity during the last 3 days. The participant was asked: “Please rate your pain intensity by assessing the one number that best describes your pain on average during the last 3 days (the last 72 hours prior to the visit)”. Where 0 = no pain and 10 indicates pain as bad as you can imagine. This is the treatment period prior to the primary outcome period.|Enrollment (Day -14); Baseline Visit (Day 1); Randomization Visit (Day 22)|Observed values.||units on a scale||Standard Deviation|Mean
698774|NCT01352741|Primary|Change in the Average Pain Intensity Score for the Overall Low Back Pain on an 11-point Numeric Rating Scale (NRS-3)|"The primary endpoint is defined as the comparison of tapentadol prolonged release (PR) 300 mg plus 200 mg per day and the combination of tapentadol PR 300 mg per day and pregabalin 300 mg per day regarding the change in NRS-3 pain intensity scores (recalled average pain intensity score during the last 3 days on 11-point NRS, where 0 is the no pain and 10 is pain as bad as you can imagine) from the randomization visit to the final evaluation visit.
Theoretically a maximum decrease of -10 and an increase of +4 in the pain intensity would have been possible. A negative sign indicates a decrease in pain intensity from the start of treatment. The higher the absolute values, the greater the change since the start of treatment (Baseline visit)."|Randomization (Day 22); Final Evaluation Visit (Day 77)|Double-Blind Comparative Population. Per Protocol Set (PPS).||units on a scale||Standard Deviation|Mean
698775|NCT01352715|Secondary|Changes in Fasting Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, Triglycerides, and Glucose From Baseline|Fasting was for 8 hours and the metabolic panel was drawn locally.|Study entry and week 48|Intention to treat: All 512 participants without a major eligibility violation with data available at entry and week 48 were included in their assigned randomized treatment arm. total cholesterol (Arm A N=216 B N=220) HDL (Arm A N=219 B N=223) LDL (Arm A N=202 B N=205) triglycerides (Arm A N=219 B N=222), glucose (Arm A N=213 B N=223)||mg/dL||95% Confidence Interval|Mean
698776|NCT01352715|Secondary|Percentage of Time Spent in Hospital|The percentage of total study time that participants were in hospital.|From study entry throughout follow-up (up to 96 weeks)|Intention to treat: All 512 participants without a major eligibility violation were in the analysis: participants were analyzed per original assigned randomized treatment.||percentage of time spent in hospital|||Number
698777|NCT01352715|Secondary|Number of Participants With a Targeted Serious Non-AIDS-defining Event or Death|Serious non-AIDS diagnoses were based on ACTG Appendix 60 Diagnosis Codes|From study entry throughout follow-up (up to 96 weeks)|Intention to treat: All 512 participants without major eligibility violations were in the analysis: participants were analyzed per original assigned randomized treatment.||participants|||Number
698778|NCT01352715|Secondary|Number of Participants With a New AIDS-defining Events or Death|AIDS-defining events were those recognized by the Centers for Disease Control (CDC) and World Health Organization (WHO)|From study entry throughout follow-up (up to 96 weeks)|Intention to treat: All 512 participants without major eligibility violations were in the analysis: participants were analyzed per original assigned randomized treatment.||participants|||Number
698779|NCT01352715|Secondary|Number of Participants Discontinuing Randomized Treatment for Toxicity|Discontinuation of randomized treatment for toxicity included participant decision to discontinue for low grade toxicity. Within class NRTI changes were not considered discontinuations.|From Start of Randomized Treatment to Off Randomized Treatment (up to 96 weeks)|Competing risk approach: Time was measured from start of randomized treatment until the date of randomized treatment discontinuation for toxicity. Randomized treatment discontinuation for other reasons was considered as an independent competing risk, and participants discontinuing the study were censored on the date of last participant contact.||participants|||Number
698780|NCT01352715|Secondary|Number of Participants With Grade 3 or Higher Adverse Event (AE) at Least One Grade Higher Than Baseline|The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs.|From start of randomized treatment to off randomized treatment (up to 96 weeks)|As treated: Participants on randomized treatment are included in this analysis.||participants|||Number
698781|NCT01352715|Secondary|Number of Participants With HIV-1 Drug Resistance Mutations in Protease, Reverse Transcriptase, and Integrase in Participants With Virologic Failure at Baseline and at Time of Virologic Failure|Mutations were defined as major IAS mutations in the IAS-USA July 2014 list. New mutations were those detected at virologic failure but not at baseline.|From study entry through to week 96|Participants with virologic failure, and with a pair of baseline and virologic failure sequences available, were included in the analysis.||participants|||Number
698782|NCT01352715|Secondary|Change in CD4+ Cell Count From Baseline to Week 48|Change in CD4+ cell count was calculated as CD4+ cell count at week 48 minus CD4+ cell count at study entry.|Study entry and week 48|Intention to treat: All 488 participants without a major eligibility violation, and with baseline and week 48 data available were used in the analysis: participants were analyzed per original assigned randomized treatment.||cells/mm^3||95% Confidence Interval|Mean
698783|NCT01352715|Primary|Cumulative Probability of Virologic Failure by Week 48|The primary endpoint was time to virologic failure. Virologic failure was defined as confirmed viral load >400 copies/mL at or after week 24. The Kaplan-Meier estimate of the cumulative probability of virologic failure by week 48 was used.|From study entry to week 48|Intention to treat: All 512 participants without a major eligibility violation were included in the analysis: participants were analyzed per original assigned randomized treatment.||cumulative probability per 100 persons||95% Confidence Interval|Number
698784|NCT01352585|Secondary|Hematocrit Level||1 year|Safety Set||Hematocrit (fraction of 1)||Standard Deviation|Mean
698785|NCT01352585|Secondary|Hemoglobin Concentration||1 year|Safety set||g/L||Standard Deviation|Mean
698786|NCT01352585|Secondary|Differential WBC Count||1 year|Safety Set||percent||Standard Deviation|Mean
698787|NCT01352585|Secondary|White Blood Cell (WBC) Count||1 year|Safety Set||WBC Count (x10^9/L)||Standard Deviation|Mean
698788|NCT01352585|Secondary|Red Blood Cell (RBC) Count||1 year|The Safety Set consisted of all subjects enrolled in the study who took at least 1 dose of anagrelide hydrochloride.||RBC Count (x10^12/L)||Standard Deviation|Mean
698789|NCT01352585|Secondary|Platelet Count||1 year|FAS||Platelets (x10^9/L)||Standard Deviation|Mean
698793|NCT01352507|Secondary|Change in International Index of Erectile Function (IIEF) Erectile Function Domain|Self-reported erectile function over the past 4 weeks. IIEF erectile function was the sum of Q1 through Q5 and Q15 of the IIEF. Q1 through Q5 were scored 0 (low/no erectile function) to 5 (high erectile function) and Q15 was scored 1 (no/low confidence) to 5 (high confidence). IIEF erectile function domain scores ranged from 1 to 30. Change was defined as endpoint minus baseline domain score. Change in IIEF erectile function domain at Week 8 and Week 18 were averaged to produce an overall change in IIEF EF domain score. Higher scores were indicative of better erectile function.|Baseline, Week 8, and Week 18|Randomized participants with baseline and at least 1 IIEF post-baseline measurement.||units on a scale||Standard Deviation|Mean
698794|NCT01352507|Secondary|Change in PAIRS Time Concerns Domain|PAIRS was a self-administered, 29-item scale that assessed the broader psychological and interpersonal outcomes associated with ED and its treatment. Each question was rated on a Likert scale that ranged from 1 (strongly disagree) to 4 (strongly agree). The time concerns domain score was the average score for Items 1, 2, 6, 7, 8, 20, 24, and 25. Time concern domain scores ranged from 1 (strongly disagree) to 4 (strongly agree). Change was defined as endpoint minus baseline domain score. Change in PAIRS time concerns at Week 8 and Week 18 were averaged to produce an overall change in PAIRS time concerns domain score. Higher scores were indicative of more time concerns.|Baseline, Week 8, and Week 18|Randomized participants with baseline and at least 1 PAIRS post-baseline measurement.||units on a scale||Standard Deviation|Mean
698795|NCT01352507|Secondary|Change in PAIRS Spontaneity Domain|PAIRS was a self-administered, 29-item scale that assessed the broader psychological and interpersonal outcomes associated with ED and its treatment. Each question was rated on a Likert scale that ranged from 1 (strongly disagree) to 4 (strongly agree). The spontaneity domain score was the average score for Items 3, 12, 13, 16, 17, 19, 21, 22, and 28. Spontaneity domain scores ranged from 1 (strongly disagree) to 4 (strongly agree). Change was defined as endpoint minus baseline domain score. Change in PAIRS spontaneity domain at Week 8 and Week 18 were averaged to produce an overall change in PAIRS spontaneity domain score. Higher scores were indicative of greater spontaneity.|Baseline, Week 8, and Week 18|Randomized participants with baseline and at least 1 PAIRS post-baseline measurement.||units on a scale||Standard Deviation|Mean
698796|NCT01352507|Secondary|Change in Sexual Encounter Profile (SEP) Question 3|"Participant-assessed diary that assessed the mean change from baseline in the percentage of yes responses to SEP Q3, Did your erection last long enough for you to have successful intercourse?. The SEP Q3 score was determined as the percentage of yes responses to SEP Q3 out of all sexual attempts recorded during the time period. Change was defined as the percentage of yes responses at endpoint minus percentage of yes responses at baseline. Change in the percentage of yes responses to SEP Q3 at Week 8 and Week 18 were averaged to produce an overall change in SEP Q3."|Baseline, Week 8, and Week 18|Randomized participants with baseline and at least 1 SEP post-baseline measurement.||"percentage of yes responses"||Standard Deviation|Mean
698797|NCT01352507|Secondary|Change in International Index of Erectile Function (IIEF) Orgasmic Function Domain|Self-reported orgasmic function over the past 4 weeks. IIEF orgasmic function was the sum of Q9 and Q10 of the IIEF. Scores ranged from 0 (no stimulation) to 5 (almost always) for each question, with the total possible score for the 2 questions ranging from 0 to 10. Change was defined as endpoint minus baseline domain score. Change in IIEF orgasmic function domain at Week 8 and Week 18 were averaged to produce an overall change in IIEF orgasmic function domain score. Higher scores were indicative of better orgasmic function.|Baseline, Week 8, and Week 18|Randomized participants with baseline and at least 1 IIEF post-baseline measurement.||units on a scale||Standard Deviation|Mean
698798|NCT01352507|Secondary|Change in International Index of Erectile Function (IIEF) Sexual Desire Domain|Self-reported sexual desire over the past 4 weeks. IIEF sexual desire was the sum of Q11 and Q12. Scores ranged from 1 (low/almost never) to 5 (very high/almost always) for each question, with the total possible score for the 2 questions ranging from 2 to 10. Change was defined as endpoint minus baseline domain score. Change in IIEF sexual desire domain at Week 8 and Week 18 were averaged to produce an overall change in IIEF sexual desire domain score. Higher scores were indicative of increased sexual desire.|Baseline, Week 8, and Week 18|Randomized participants with baseline and at least 1 IIEF post-baseline measurement.||units on a scale||Standard Deviation|Mean
698799|NCT01352507|Secondary|Change in International Index of Erectile Function (IIEF) Intercourse Satisfaction Domain|Self-reported intercourse satisfaction over the past 4 weeks. IIEF intercourse satisfaction was the sum of Q6, Q7, and Q8 of the IIEF. Scores ranged from 0 (low/no satisfaction) to 5 (high satisfaction) for each question, with the total possible score for the 3 questions ranging from 0 to 15. Change was defined as endpoint minus baseline domain score. Change in IIEF intercourse satisfaction domain at Week 8 and Week 18 were averaged to produce an overall change in IIEF intercourse satisfaction domain score. Higher scores were indicative of an increase in intercourse satisfaction.|Baseline, Week 8, and Week 18|All randomized participants with baseline and at least 1 IIEF post-baseline measurement.||units on a scale||Standard Deviation|Mean
698800|NCT01352507|Secondary|Drug Attributes Questionnaire (DRAQ) at Week 18|DRAQ was a questionnaire used to record explanations for why participants preferred a drug. Participants identified their first and second reasons for drug preference from a choice of 7 reasons. Each reason for drug preference includes participants who selected that reason as their first or second reason.|Week 18|Randomized participants who completed both treatment periods (Week 18), responded to the DRAQ, and were analyzed according to their assigned treatment.||percentage of participants|||Number
698801|NCT01352507|Secondary|Change in Psychosocial and Interpersonal Relationship Scale (PAIRS) Sexual Self-Confidence Domain|PAIRS was a self-administered, 29-item scale that assessed the broader psychological and interpersonal outcomes associated with ED and its treatment. Each question was rated on a Likert scale that ranged from 1 (strongly disagree) to 4 (strongly agree). The sexual self-confidence domain score was the average score for Items 5, 10, 15, 23, 27, and 29. Sexual self-confidence domain scores ranged from 1 (strongly disagree) to 4 (strongly agree). Change was defined as endpoint minus baseline domain score. Change in PAIRS sexual self-confidence domain scores at Week 8 and Week 18 were averaged to produce an overall change in PAIRS sexual self-confidence domain score. Higher scores were indicative of greater sexual self-confidence.|Baseline, Week 8, and Week 18|Randomized participants with baseline and at least 1 PAIRS post-baseline measurement.||units on a scale||Standard Deviation|Mean
699131|NCT01348139|Secondary|E5min: The Value of FEV1 at 5 Min for Every Treatment Visit.|Onset of effect (E5min), observed at 5 min. FEV1 for treatment visits 2 to 7.|FEV1 at 5 min|PD analysis set||Liters||Standard Deviation|Mean
698802|NCT01352507|Secondary|Change in Sexual Encounter Profile (SEP) Question 2|"Participant-assessed diary that assessed the mean change from baseline in the percentage of yes responses to SEP Q2, Were you able to insert your penis into your partner's vagina?. The SEP Q2 score was determined as the percentage of yes responses to SEP Q2 out of all sexual attempts recorded during the time period. Change was defined as the percentage of “yes” responses at endpoint minus the percentage of “yes” responses at baseline. Change in percentage of “yes” responses to SEP Q2 at Week 8 and Week 18 were averaged to produce an overall change in SEP Q2."|Baseline, Week 8, and Week 18|Randomized participants with baseline and at least 1 post-baseline SEP measurement.||"percentage of yes responses"||Standard Deviation|Mean
698803|NCT01352507|Secondary|Change in International Index of Erectile Function (IIEF) Overall Satisfaction Domain|Self-reported overall satisfaction over the past 4 weeks. IIEF overall satisfaction was the sum of Q13 and Q14. Scores ranged from 1 (low/no satisfaction) to 5 (high satisfaction) for each question, with the total possible score for the 2 questions ranging from 2 to 10. Change was defined as endpoint minus baseline domain score. Change in IIEF overall satisfaction domain at Week 8 and Week 18 were averaged to produce an overall change in IIEF overall satisfaction domain score. Higher IIEF overall satisfaction domain scores were indicative of greater overall satisfaction.|Baseline, Week 8, and Week 18|All randomized participants with baseline and at least 1 IIEF post-baseline measurement.||units on a scale||Standard Deviation|Mean
698804|NCT01352507|Secondary|Percentage of Participants Moderately or Strongly Preferring the Selected Treatment at Week 18 Using Question 2 of the PITPQ|PITPQ Q2 was a measure of the degree of treatment preference based on the participant's opinion. The question was, “For the treatment preference you selected in Q1, what is your degree of preference?”. Choices were moderate or strong.|Week 18|Randomized participants who completed both treatment periods (Week 18), responded to the PITPQ, and were analyzed according to their assigned treatment.||percentage of participants|||Number
698805|NCT01352507|Primary|"Percentage of Participants Preferring Tadalafil Over Sildenafil Measured at Week 18 Using Question 1 of the Phosphodiesterase 5 Inhibitor Treatment Preference Questionnaire (PITPQ)"|PITPQ Question (Q) 1 was a dichotomous outcome measure in which the participant selected his preferred study treatment (tadalafil or sildenafil) to receive during the Extension Phase.|Week 18|Randomized participants who completed both treatment periods (Week 18), responded to the PITPQ, and were analyzed according to their assigned treatment.||percentage of participants||95% Confidence Interval|Number
698806|NCT01352468|Secondary|Proportion of Words Read Accurately Using the AIMSWEB|Number of words read correctly divided by number of words read|8 weeks|||proportion of words read accurately||Standard Deviation|Mean
698807|NCT01352468|Secondary|Reaction Time Variability on go/No-go Task|Standard deviation of reaction times for correct responses to Go trials on a Go/No-Go Task|8 weeks|Go/No-Go task data was not available for one participant in the Sham Cognitive Training condition||milliseconds||Standard Deviation|Mean
698808|NCT01352468|Primary|Total ADHD Symptom Score From Vanderbilt ADHD Parent Rating Scale|"Total ADHD Symptom Score on the Parent Vanderbilt Rating Scales; range = 0-54; this score is computed by summing the 18 ADHD symptom items which are each rated on a 0-3 Likert scale (0=Never; 1=Occasionally; 2=Often; 3=Very often); higher scores indicate higher severity of ADHD symptoms."|8 weeks|||units on a scale||Standard Deviation|Mean
698809|NCT01352442|Secondary|Subjective Rating of Near Visual Acuity at 12 Months as Measured by Subjective Questionnaire|Mean subjective rating via questionnaire on 1 to 7 rating scale (1= very dissatisfied and 7 = very satisfied).|12 months|||Scores on a scale||95% Confidence Interval|Mean
698810|NCT01352442|Primary|Uncorrected Near Visual Acuity 20/32 or Better||12 months|||percentage of subjects|||Number
698811|NCT01352416|Primary|Freedom From Any Episode of Post Operative Atrial Fibrillation Longer Than 6 Hours Duration Occurring During the Study Period.|Freedom from any episode of post operative Atrial Fibrillation (AF) longer than 6 hours duration occurring during the study period. To document post operative atrial fibrillation.|The time between the completion of the operation and hospital discharge or 14 days post operative if the hospitalzation is prolonged|Study was prematurely terminated. Data for this Outcome Measure were not collected|||||
698812|NCT01352117|Secondary|Cumulative Incidence of KS Response After Initiation of Delayed Etoposide in Arm A|KS response, partial or complete (PR or CR) compared to Step 2 entry (prior to initiation of delayed ET) based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). Cumulative incidence was estimated with death and initiation of alternate KS treatment as competing risks. Time at risk was censored at the end of Step 2 (at up to 84 weeks or premature study discontinuation) or on the date when the DSMB's recommendation to close the study became public, whichever occurred earlier.|From initiation of etoposide (Step 2 entry) to up to 84 weeks (end of Step 2)|All Arm A participants who experienced KS progression and entered Step 2 to initiate delayed ET.||cumulative events per 100 participants||95% Confidence Interval|Number
698813|NCT01352117|Secondary|Cumulative Incidence of KS Progressive Disease After Initiation of Delayed Etoposide in Arm A|KS progressive disease (PD) compared to Step 2 entry (prior to initiation of delayed ET) or Step 2 best response based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). Cumulative incidence was estimated with death and initiation of alternate KS treatment as competing risks. Time at risk was censored at the end of Step 2 (at up to 84 weeks or premature study discontinuation) or on the date when the DSMB's recommendation to close the study became public, whichever occurred earlier.|From initiation of etoposide (Step 2 entry) to up to 84 weeks (end of Step 2)|All Arm A participants who experienced KS progression and entered Step 2 to initiate delayed ET.||cumulative events per 100 participants||95% Confidence Interval|Number
698814|NCT01352117|Secondary|Change in Peripheral Blood CD4+ Lymphocyte Cell Count|Absolute change in CD4+ cell count was calculated as value at a given visit minus the value at study screening in Step 1, and as value at a given visit minus Step 2 entry in Step 2. Only participants in Arm A could enter Step 2 to initiate delayed ET.|Screening and Weeks 12, 24, 32, 48, 72, 96; Step 2 entry and Weeks 12, 24, 32, 48 and 72.|All eligible participants who initiated study treatment and had CD4 cell count results available at screening and the respective Step 1 visit or at Step 2 entry and the respective Step 2 visit.||cells/mm^3||Inter-Quartile Range|Median
740029|NCT00461734|Secondary|Incidence of Stroke||At 5-year follow-up (study extension)|||participants|||Number
698815|NCT01352117|Secondary|Change in log10 HIV-1 Plasma Viral Load From Entry|Absolute change in log10 HIV-1 RNA from entry at study visits calculated as value at a given time point minus value at entry. This outcome was initially specified in the study protocol. However, at the first post-entry visit, most participants had unquantifiable HIV-1 RNA levels. It would be misleading to calculate change from entry to HIV RNA-1 levels that could not be quantified. Therefore, the data collected did not support the outcome and the analytic method initially proposed in the study protocol, and this outcome measure could not be analyzed. The SAP updated the HIV-1 RNA outcome measure to HIV-1 RNA suppression at study visits (please refer to the secondary outcome measure #20).|Entry and Weeks 12, 24, 32, 48, 72, 96; Step 2 entry and Weeks 12, 24, 32, 48 and 72.|At the first post-entry visit, most participants had unquantifiable HIV-1 RNA levels. Therefore, this outcome measure could not be analyzed.|||||
698816|NCT01352117|Secondary|Percentage of Participants With ARV Dose Modification|ARV dose modifications were reported as temporarily held, prematurely discontinued and increased. The percentage of participants who experienced each dose modification is provided in the data table below. The categories are not mutually exclusive. A participant may have experienced multiple dose modifications and may be counted in more than one category. Each participant is counted at most once within category.|From treatment dispensation to Week 96|All eligible participants who initiated study treatment.||percentage of participants|||Number
698817|NCT01352117|Secondary|Percentage of Participants With HIV-1 RNA Suppression|HIV-1 RNA suppression was defined as plasma HIV-1 RNA <400 copies/mL. Only Arm A participants could enter Step 2 to initiate delayed ET.|Entry and Weeks 12, 24, 32, 48, 72, 96; Step 2 entry and Weeks 12, 24, 32, 48 and 72.|All eligible participants who initiated study treatment and had HIV-1 RNA results available at the specific visit. HIV-1 RNA testing was done locally using Abbott RealTime HIV-1 Test or Roche AmpliPrep/Taqman HIV-1 Test. Only Arm A participants could enter Step 2 to initiate delayed ET.||percentage of participants|||Number
698818|NCT01352117|Secondary|Percentage of Participants With Etoposide Dose Modification|Etoposide (ET) was administered for a maximum of 8 cycles (16 weeks) from study entry (Arm B) or from Step 2 entry (Arm A). Dose modifications were reported as temporarily held, resumed at a different dose, deferred, prematurely discontinued and underdosed. The percentage of participants who experienced each dose modification is provided in the data table below. The categories are not mutually exclusive. A participant may have experienced multiple dose modifications and may be counted in more than one category. Each participant is counted at most once within category.|From ET dispensation to ET discontinuation (total duration of ET was up to 16 weeks)|All eligible participants who initiated study treatment. Arm A participants are limited to those who entered Step 2 to initiate delayed ET.||percentage of participants|||Number
698819|NCT01352117|Secondary|Cumulative Incidence of KS-IRIS|KS-IRIS was defined as KS progressive disease that occurs within 12 weeks of initiation of ART that is associated with an increase in peripheral blood CD4+ lymphocyte cell count of at least 50 cells/mm^3 above the study screening value and/or a decrease in the HIV RNA level by at least 0.5 log10 below the study entry value prior to, or at the time of, documented KS progressive disease. Cumulative incidence was estimated with death and initiation of alternate KS treatment as competing risks. Time at risk was censored (1) when lost to follow-up, (2) at the study visit following Week 12 or (3) on the date when the DSMB's recommendation to close the study became public, whichever occurred earlier. Time of KS-IRIS was defined as the time of the initial KS progressive disease.|From study entry to Week 12|All eligible participants who initiated study treatment.||cumulative events per 100 participants||95% Confidence Interval|Number
698820|NCT01352117|Secondary|Number of Participants With Grade 3 or Higher Adverse Events|Number of participants who experienced an AE (sign/symptom or laboratory abnormality) of Grade 3 or higher. The AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (see reference in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening.|From study treatment dispensation through up to Week 96, until long-term follow-up began in Step 3 or until study discontinuation.|All eligible participants who initiated study treatment.||Participants|||Count of Participants
698821|NCT01352117|Secondary|Cumulative Incidence of Initial KS Complete Response by Week 96|KS complete response (CR) compared to study entry based on clinical evaluation of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). This was initially part of the outcome specified in the study protocol as “PR and CR combined and separately” to address the secondary objective on the KS response. Due to the extremely limited number of participants with KS CR, the Statistical Analysis Plan was updated, and the Final Analysis was conducted only on the combined KS response. The outcome on CR separately was withdrawn.|From study treatment initiation to 96 weeks|Due to the extremely limited number of participants with KS CR, KS partial response (PR) and CR were combined. The analyses of CR and PR separately which were initially specified in the study protocol were withdrawn.|||||
698822|NCT01352117|Secondary|Cumulative Incidence of Initial KS Partial Response by Week 96|KS partial response (PR) compared to study entry based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). This was initially part of the outcome specified in the study protocol as “PR and CR combined and separately” to address the secondary objective on the KS response. Due to the extremely limited number of participants with KS complete response, the Statistical Analysis Plan was updated, and the Final Analysis was conducted only on the combined KS response. The outcome on PR separately was withdrawn.|From study treatment initiation to 96 weeks|Due to the extremely limited number of participants with KS CR, KS partial response (PR) and CR were combined. The analyses of CR and PR separately which were initially specified in the study protocol were withdrawn.|||||
698823|NCT01352117|Secondary|Cumulative Incidence of Initial KS Partial or Complete Response by Week 96|KS partial response (PR) or complete response (CR) compared to study entry based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). Cumulative incidence was estimated with death and initiation of delayed KS treatment (alternate KS treatment or delayed ET in Arm A) as competing risks. Time at risk was censored at the end of Step 1 (Week 96 or premature study discontinuation) or on the date when the DSMB's recommendation to close the study became public, whichever occurred earlier.|From entry through 96 weeks|All eligible participants who initiated study treatment.||cumulative events per 100 participants||95% Confidence Interval|Number
698824|NCT01352117|Secondary|Cumulative Incidence of Initial KS Progressive Disease by Week 96|KS progressive disease (PD) compared to study entry or best response based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). Cumulative incidence was estimated with death and initiation of alternate KS treatment as competing risks. Time at risk was censored at the end of Step 1 (Week 96 or premature study discontinuation) or on the date when the DSMB's recommendation to close the study became public, whichever occurred earlier.|From entry through 96 weeks|All eligible participants who initiated study treatment.||cumulative events per 100 participants||95% Confidence Interval|Number
698825|NCT01352117|Secondary|Premature Study Discontinuation by Week 96|Premature study discontinuation by Week 96 due to any reason, including death.|Entry through Week 96|All eligible participants who initiated study treatment and had Study Week 96 data potential (i.e. participants enrolled at least 93 weeks prior to the date when the DSMB's recommendation to close the study became public).||Participants|||Count of Participants
698826|NCT01352117|Secondary|KS Partial or Complete Response at Week 96 Compared to Study Entry|KS partial response (PR) or complete response (CR) compared to study entry based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002).|Entry and Week 96|All eligible participants who initiated study treatment and had Study Week 96 data potential (i.e. participants enrolled at least 93 weeks prior to the date when the DSMB's recommendation to close the study became public) who had Week 96 KS exam performed and had not initiated alternate KS treatment before Week 96.||Participants|||Count of Participants
698827|NCT01352117|Secondary|KS Complete Response at Week 96 Compared to Study Entry|KS complete response (CR) compared to study entry based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002).|Entry and Week 96|All eligible participants who initiated study treatment and had Study Week 96 data potential (i.e. participants enrolled at least 93 weeks prior to the date when the DSMB's recommendation to close the study became public) who had Week 96 KS exam performed and had not initiated alternate KS treatment before Week 96.||Participants|||Count of Participants
698828|NCT01352117|Secondary|KS Partial Response at Week 96 Compared to Study Entry|KS partial response (PR) compared to study entry based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002).|Entry and Week 96|All eligible participants who initiated study treatment and had Study Week 96 data potential (i.e. participants enrolled at least 93 weeks prior to the date when the DSMB's recommendation to close the study became public) who had Week 96 KS exam performed and had not initiated alternate KS treatment before Week 96.||Participants|||Count of Participants
698829|NCT01352117|Secondary|KS Progressive Disease at Week 96 Compared to Study Entry|KS progressive disease (PD) compared to study entry based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002).|Entry and Week 96|All eligible participants who initiated study treatment and had Study Week 96 data potential (i.e. participants enrolled at least 93 weeks prior to the date when the DSMB's recommendation to close the study became public) who had Week 96 KS exam performed and had not initiated alternate KS treatment before Week 96.||Participants|||Count of Participants
698830|NCT01352117|Secondary|Kaposi Sarcoma (KS) Status at Week 96 Compared to Study Entry|KS status is a composite, categorical outcome, ordered from worst to best as E1 (Failure: KS PD, initiation of an alternate KS treatment, or no follow-up at Week 96 including death and missed visit), E2 (Stable: in follow-up at Week 96 with no KS progression nor response and without initiation of an alternate KS treatment) and E3 (Response: in follow-up at Week 96, with KS PR or CR and without initiation of an alternate KS treatment). Alternate KS treatment was defined as chemotherapy agent other than ET or other treatment triggered by worsening KS. KS outcome status (PD, stable, PR or CR) compared to study entry was evaluated at Week 96 based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). Data on initiation of alternate KS treatment, loss to follow-up and deaths are from entry through Week 96.|Entry through Week 96.|All eligible participants who initiated study treatment and had Study Week 96 data potential (i.e. participants enrolled at least 93 weeks prior to the date when the DSMB's recommendation to close the study became public).||Participants|||Count of Participants
698831|NCT01352117|Secondary|Premature Study Discontinuation by Week 48|Premature study discontinuation by Week 48 due to any reason, including death.|Entry through Week 48|All eligible participants who initiated study treatment and had Study Week 48 data potential (i.e. participants enrolled at least 45 weeks prior to the date when the DSMB's recommendation to close the study became public).||Participants|||Count of Participants
698832|NCT01352117|Secondary|KS Partial or Complete Response at Week 48 Compared to Study Entry|KS partial response (PR) or complete response (CR) compared to study entry based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002).|Entry and Week 48|All eligible participants who initiated study treatment and had Study Week 48 data potential (i.e. participants enrolled at least 45 weeks prior to the date when the DSMB's recommendation to close the study became public) who had Week 48 KS exam performed and had not initiated alternate KS treatment before Week 48.||Participants|||Count of Participants
698833|NCT01352117|Secondary|KS Complete Response at Week 48 Compared to Study Entry|KS complete response (CR) compared to study entry based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002).|Entry and Week 48|All eligible participants who initiated study treatment and had Study Week 48 data potential (i.e. participants enrolled at least 45 weeks prior to the date when the DSMB's recommendation to close the study became public) who had Week 48 KS exam performed and had not initiated alternate KS treatment before Week 48.||Participants|||Count of Participants
699132|NCT01348139|Secondary|tEmax: Time to Maximum Value of FEV1 for Every Treatment Visit|Time to peak effect (tEmax), within 0-24 hours of FEV1, for treatment visits 2 to 7.|0 - 24 hrs.|PD analysis set||Hours||Full Range|Median
698834|NCT01352117|Secondary|KS Partial Response at Week 48 Compared to Study Entry|KS partial response (PR) compared to study entry based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002).|Entry and Week 48|All eligible participants who initiated study treatment and had Study Week 48 data potential (i.e. participants enrolled at least 45 weeks prior to the date when the DSMB's recommendation to close the study became public) who had Week 48 KS exam performed and had not initiated alternate KS treatment before Week 48.||Participants|||Count of Participants
698835|NCT01352117|Secondary|KS Progressive Disease at Week 48 Compared to Study Entry|KS progressive disease (PD) compared to study entry based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002).|Entry and Week 48|All eligible participants who initiated study treatment and had Study Week 48 data potential (i.e. participants enrolled at least 45 weeks prior to the date when the DSMB's recommendation to close the study became public) who had Week 48 KS exam performed and had not initiated alternate KS treatment before Week 48.||Participants|||Count of Participants
698836|NCT01352117|Primary|Kaposi Sarcoma (KS) Status at Week 48 Compared to Study Entry|KS status is a composite, categorical outcome, ordered from worst to best as E1 (Failure: KS progression (PD), initiation of an alternate KS treatment, or no follow-up at Week 48 including death and missed visit), E2 (Stable: in follow-up at Week 48 with no KS PD nor response and without initiation of an alternate KS treatment) and E3 (Response: in follow-up at Week 48, with KS partial or complete response (PR or CR) and without initiation of an alternate KS treatment). Alternate KS treatment was defined as chemotherapy agent other than ET or other treatment triggered by worsening KS. KS outcome status (PR, stable, PR, CR) compared to study entry was evaluated at Week 48 based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). Data on initiation of alternate KS treatment, loss to follow-up and dea|Entry through Week 48.|All eligible participants who initiated study treatment and had Study Week 48 data potential (i.e. participants enrolled at least 45 weeks prior to the date when the Data and Safety Monitoring Board's [DSMB] recommendation to close the study became public).||Participants|||Count of Participants
698837|NCT01351623|Primary|To Evaluate the Best Overall Response Rate (ORR)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (POD); POD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions|2 years|Participants who completed 4 cycles of treatment or whose disease progressed prior to completion of 4 cycles.||Participants|||Count of Participants
698838|NCT01351506|Secondary|Acute Kidney Injury|New acute kidney injury in ICU|Acute kidney injury|||participants|||Number
698839|NCT01351506|Secondary|Re Intubation Within 72 Hours|Patient who need re-intubation within 72 hours|ICU complications up to 28 days after ICU admission|All||participants|||Number
698840|NCT01351506|Primary|In Hospital Mortality|28 days mortality if patient still have be admitted in hospital.|within 28 days after ICU admission to dead|Total 465 patients||participants|||Number
698841|NCT01351480|Secondary|Number of Patients With Adverse Events|site will report the number of patients with adverse envents from Day 1 up to 52 weeks|all adverse events will be captured from Day 1 up to 52 weeks|There were 34 enrolled patients with 7 patients who early termed so analysis was performed on 27 patients||participants|||Number
698842|NCT01351480|Secondary|the Clinical Outcomes Measurements (American College of Rheumatology Activity Scoring, Health Assessment The Number of Patients With a Clinical Response at Week 24 and 48|Patient with a positive change in DAS score were considered responders . The DAS score is calculated using the number of tender and swollen joints based upon a 28 joint count, the ESR in mm/hr., and the physician global score (1-10 cm). Total maximum score was at high disease activity at baseline.|week 24 and Week 48|There were 34 enrolled patients with 7 patients who early termed so analysis was performed on 27 patients||participants|||Number
698843|NCT01351480|Secondary|To Measure the Change From Baseline in Patient DAS 28 Scores at Baseline and Weeks 12, 24|DAS 28> 5.1=high disease activity DAS28 <3.2=low disease activity DAS28 <2.6=remission Criteria used in formula are number of tender joints based upon 28 joints, number of swollen joints based on 28 joints, ESR in mm/hr and patient global health core based on 0-10 mm|Patient DAS 28 scores will be measured at baseline and weeks 12, 24, 48 and disease activity will be recorded at Week 48|the number of participants who reached remission, low disease activity, moderate disease activity and high disease activity will be determined as based upon the DAS scale||participants|||Number
698844|NCT01351480|Secondary|Patients With an Improvement in DAS Score Were Considered Responders at Week 48|Patient with a positive change in DAS score were considered responders . The DAS score is calculated using the number of tender and swollen joints based upon a 28 joint count, the ESR in mm/hr., and the physician global score|The DAS 28 score will be performed at baseline and 48|There were 34 enrolled patients with 7 patients who early termed so analysis was performed on 27 patients||participants|||Number
698845|NCT01351480|Primary|Number of Participants With an Improvement in Bone Edema/Osteitis on Low-field MRI in Rheumatoid Arthritis Patients on Weekly SC Abatacept in Combination With Methotrexate Over a 12-month Period.|bone edema/osteitis using low-field MRI analysis of 25 anatomical locations in the wrist and hand and scoring the volume of the original articular bone in 0.5 increments from 0-3, with each increment in the scale representing 33% of the volume of the peripheral 1 cm of original (eroded + residual) articular bone.|MRIs at Baseline and Week 48|osteitis on the MRIs from 27 patients at baseline and week 48||participants|||Number
698846|NCT01351415|Secondary|Percentage of Participants Who Are Alive at Month 6, 12, and 18|Percentage of participants who were alive at Month 6, 12 and 18 were reported.|Month 6, 12, 18|Intent to treat population included all randomized participants.||Percentage of Participants||90% Confidence Interval|Number
698896|NCT01350973|Secondary|Percent Change From Baseline in Total Cholesterol Over Time|The percentage change between total cholesterol measured at each study visit relative to Baseline.|Baseline and Weeks 4, 8, 10 and 12|"Full analysis set with available data at each time point (indicated by n)."||percent change||Standard Deviation|Mean
698847|NCT01351415|Secondary|Time to Progression (TTP) According to RECIST v1.1|The time to progression was defined as the time from baseline until disease progression as determined by the RECIST v1.1. TTP2 is defined as the interval between the day of randomization at PD1 and PD2. TTP3 is defined as the interval between the day of PD2 and PD3. PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.|Up to data cut-off date 24 June 2016 (approximately 5 years)|Intent to treat population included all randomized participants.||Months||90% Confidence Interval|Median
698848|NCT01351415|Secondary|Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events. A SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant.|Up to data cut-off date 24 June 2016 (approximately 5 years)|The safety population included all participants who had received at least one dose of any study drug.||Percentage of Participants|||Number
698849|NCT01351415|Secondary|Duration of Response (DoR) According to RECIST v1.1|Duration of response is defined as the time that measurement criteria are met for objective response (CR/PR) (whichever status is recorded first) until the first date of progression or death is documented. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than < 10 mm. PR was defined as greater than or equal to ≥30 % decrease in sum of longest diameter of target lesions in reference to baseline sum longest diameter.|Up to data cut-off date 24 June 2016 (approximately 5 years)|Intent to treat population included all randomized participants.||Months||90% Confidence Interval|Median
698850|NCT01351415|Secondary|Percentage of Participants With Disease Control According to RECIST v1.1|The disease control rate is defined as CR or PR or stable disease (SD) assessed according to the RECIST v.1.1 criteria with baseline tumour assessment as the reference. SD was defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of the longest diameter since treatment started for target lesions and the persistence of 1 or more non-target lesions.|Up to data cut-off date 24 June 2016 (approximately 5 years)|Intent to treat population included all randomized participants.||Percentage of Participants||90% Confidence Interval|Number
698851|NCT01351415|Secondary|Percentage of Participants With Objective Response According to RECIST v1.1|The objective response is defined as complete response (CR) or partial response (PR) assessed according to the RECIST v.1.1 criteria with baseline tumour assessment as the reference. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as greater than or equal to (≥) 30 percent (%) decrease in sum of longest diameter (LD) of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR.|Up to data cut-off date 24 June 2016 (approximately 5 years)|Intent to treat population included all randomized participants.||Percentage of Participants||90% Confidence Interval|Number
698852|NCT01351415|Secondary|Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)|PFS was defined as the time from start of treatment to the first event of death or PD. Tumor response was assessed by the IRF according to RECIST v1.1. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. PFS2 is defined as the time between randomization at PD1 and the date of PD2 or death, whichever occurs first. PFS3 is defined as the time between PD2 and the date of PD3 or death, whichever occurs first.|Up to data cut-off date 24 June 2016 (approximately 5 years)|Intent to treat population included all randomized participants.||Months||90% Confidence Interval|Median
698853|NCT01351415|Primary|Overall Survival (OS)|Overall survival (OS) was defined as the time from the date of randomization at first progression of disease to the date of death, regardless of the cause of death.|Up to data cut-off date 24 June 2016 (approximately 5 years)|Intent to treat population included all randomized participants.||Months||90% Confidence Interval|Median
698854|NCT01351337|Other Pre-specified|The Specificity, Sentitivity of DTI Tractography and Accordance Rate of DTI With DsCS Results|The sensitivity of DTI tractography for PT mapping was calculated as the ratio between the number of subjects with positive DsCS results in the positive DTI zone (true positive) and the total number of subjects with positive DsCS results (true positive plus false negative). The specificity was measured as the ratio between the number of subjects with negative DsCS results in the negative DTI zone (true negative) and the total number of subjects with negative DsCS results (true negative plus false positive). The accordance rate of DsCS and DTI was measured as the ratio between the number of subjects with either a true-positive or true-negative DsCS result and the total number of subjects.|During the operation|||percentage of stimulation sites|||Number
698855|NCT01351337|Secondary|Postoperative Motor Function and Long-time Functional Status|Motor function was assessed early postoperatively (within 72 hours after the operation), and 1 month after discharge. The muscle strength of each subject was graded for both the upper and lower extremities with the Medical Research Council Scale. Grade 5: Muscle contracts against full resistance; Grade 4: Strength reduced, but contraction can still move joint against resistance; Grade 3: Strength further reduced such that joint can be moved only against gravity with examiner's resistance completely removed. Grade 2: Muscle can onlly move if resistance of gravity is removed. Grade 1: Only a trace or flicker of movement is seen or felt, or fasciculations are observed; Grade 0:No movement.|3 days to 6 months after surgery|||participants|||Number
698894|NCT01350973|Secondary|Percent Change From Baseline in Non-High-Density Lipoprotein - Cholesterol Level Over Time|The percentage change between non-high-density lipoprotein cholesterol collected at each study visit relative to Baseline. Non-high-density lipoprotein cholesterol calculated by subtracting high-density lipoprotein cholesterol from total cholesterol.|Baseline and Weeks 4, 8, 10 and 12|"Full analysis set with available data at each time point (indicated by n)."||percent change||Standard Deviation|Mean
698856|NCT01351337|Primary|Extent of Tumor Resection|Volumetric analysis was performed both before and after surgery by calculating the tumor volume on the images of enhanced 3-D MP-RAGE sequence for high-grade gliomas and FLAIR sequence for low-grade gliomas. The extent of tumor resection was the ratio of pre-op tumor volume over post-op tumor volume. Gross total resection refers to a 100% resection of the tumor volume; near-total resection refers to 95% to 100% resection; subtotal resection refers to 90% to 95% resection; partial resection refers to 75% to 90% resection; and biopsy refers to ,75% resection of the tumor volume for histological diagnosis.|within 3 days|||participants|||Number
698857|NCT01351090|Secondary|Pain Intensity Difference (PID) Scores|Ratings of Pain Intensity (PI) were made using a 100-mm Visual Analog Scale (VAS) on which 0 = no pain and 100 = worst pain possible. PID was calculated by subtracting the posttreatment score from the baseline score, where the baseline score was the PI rating made prior to the first dose of study medication.|6 hours after study drug administration|||units on a scale||Standard Deviation|Mean
698858|NCT01351090|Secondary|Total MS Use in Milligrams by PCA From 24 Hours After the Start of Dosing Through 48 Hours||8-hour intervals from 24 hours after the start of dosing through 48 hours|||mg||Standard Deviation|Mean
698859|NCT01351090|Secondary|Total MS Use in Milligrams by PCA From the Start of Dosing Through 48 Hours||8-hour intervals from the start of dosing through 48 hours|||mg||Standard Deviation|Mean
698860|NCT01351090|Primary|Total Morphine Sulfate (MS) Use in Milligrams by Patient-controlled Analgesia (PCA) Through 24 Hours||8-hour intervals from the start of dosing through 24 hours|||mg||Standard Deviation|Mean
698861|NCT01351077|Other Pre-specified|Number of Patients Whose Referred Evaluations and Services Were Completed||one year|||Participants|||Count of Participants
698862|NCT01351077|Other Pre-specified|Number of Children Referred for Evaluation and Services When There Was a Positive Screening Result||one year|The denominator was the number of children with a positive screen||Participants|||Count of Participants
698863|NCT01351077|Other Pre-specified|Number of Children With a Positive Screen||one year|The denominator was number of children for whom a standard developmental screening tool was administered||Participants|||Count of Participants
698864|NCT01351077|Secondary|Age of Children Diagnosed With Developmental Delay||one year|The denominator was only children diagnosed with developmental delay||months||Standard Deviation|Mean
698865|NCT01351077|Primary|Number of Children Screened for Developmental Delay||one year|||Participants|||Count of Participants
698866|NCT01351064|Secondary|Percent of Patients Receiving ADHD Care Component||one year|||percentage of participants|||Number
698867|NCT01351064|Primary|Number of Children Diagnosed With ADHD With Structured Diagnostic Assessment||one year|||number of kids|||Number
698868|NCT01351025|Secondary|Number of Participants With Safety Endpoints After Study Treatment Cross-over (Week 24 to Week 48)|"Safety endpoints are defined as grade ≥ 2 signs and symptoms, laboratory abnormalities, AST/ALT > 3 X ULN, and adverse events after study treatment cross-over (week 24 to week 48).
The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs."|week 24 to week 48|participants who crossed over study treatment at week 24||participants|||Number
698869|NCT01351025|Secondary|Number of Participants With Safety Endpoints Before Study Treatment Cross-over (Baseline to Week 24)|"Safety endpoints are defined as grade ≥ 2 signs and symptoms, laboratory abnormalities, AST/ALT > 3 X ULN, and adverse events prior to study treatment cross-over (baseline to week 24).
The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs."|week 0 to week 24|participants who started study treatment||participants|||Number
698870|NCT01351025|Secondary|Difference Between [Change From Week 24 to Week 44] and Change From [Baseline to Week 20] in sCD163 (log10 Transformed)|"CD163 (Cluster of Differentiation 163) is a protein that in humans encoded by the CD163 gene; and sCD163 is soluble CD163.
Difference between [change from week 24 to week 44] and change from [baseline to week 20] is defined as [week 44 - week 24] - [week 20 - baseline]."|baseline, week 20, week 24, and week 44|This analysis was as-treated, limited to participants who had data for baseline, week 20, week 24, and week 44, and remained on study treatment through week 44 (allowing treatment interruption < 4 weeks), and did not use prohibited medications or have virologic failure during the course of the study.||log10 ng/ml||Inter-Quartile Range|Median
698871|NCT01351025|Secondary|Difference Between [Change From Week 24 to Week 44] and Change From [Baseline to Week 20] in P-selectin (log10 Transformed)|"P-selectin is a protein that in humans encoded by the SELP gene. P-selectin functions as a cell adhesion molecule (CAM) on the surfaces of activated endothelial cells, which line the inner surface of blood vessels, and activated platelets.
Difference between [change from week 24 to week 44] and change from [baseline to week 20] is defined as [week 44 - week 24] - [week 20 - baseline]."|baseline, week 20, week 24, and week 44|This analysis was as-treated, limited to participants who had data for baseline, week 20, week 24, and week 44, and remained on study treatment through week 44 (allowing treatment interruption < 4 weeks), and did not use prohibited medications or have virologic failure during the course of the study.||log10 ng/ml||Inter-Quartile Range|Median
698872|NCT01351025|Secondary|Difference Between [Change From Week 24 to Week 44] and Change From [Baseline to Week 20] in sCD14 (log10 Transformed)|Soluble cluster of differentiation 14 (sCD14) is a human gene. Difference between [change from week 24 to week 44] and change from [baseline to week 20] is defined as [week 44 - week 24] - [week 20 - baseline].|baseline, week 20, week 24, and week 44|This analysis was as-treated, limited to participants who had data for baseline, week 20, week 24, and week 44, and remained on study treatment through week 44 (allowing treatment interruption < 4 weeks), and did not use prohibited medications or have virologic failure during the course of the study.||log10 ng/ml||Inter-Quartile Range|Median
698873|NCT01351025|Secondary|Difference Between [Change From Week 24 to Week 44] and Change From [Baseline to Week 20] in CD40L (log10 Transformed)|"Cluster of differentiation 40 (CD40L) is a costimulatory protein found on antigen presenting cells and is required for their activation.
Difference between [change from week 24 to week 44] and change from [baseline to week 20] is defined as [week 44 - week 24] - [week 20 - baseline]."|baseline, week 20, week 24, and week 44|This analysis was as-treated, limited to participants who had data for baseline, week 20, week 24, and week 44, and remained on study treatment through week 44 (allowing treatment interruption < 4 weeks), and did not use prohibited medications or have virologic failure during the course of the study.||log10 pg/ml||Inter-Quartile Range|Median
740030|NCT00461734|Secondary|All Cause Mortality||At 5-year follow-up (study extension)|||participants|||Number
698874|NCT01351025|Secondary|Difference Between [Change From Week 24 to Week 44] and Change From [Baseline to Week 20] in IP-10 (log10 Transformed)|"IFN-gamma-inducible protein 10 (IP-10 or CXCL10) is a chemokine secreted from cells stimulated with type I and II IFNs and LPS, is also a chemoattractant for activated T cells.
Difference between [change from week 24 to week 44] and change from [baseline to week 20] is defined as [week 44 - week 24] - [week 20 - baseline]."|baseline, week 20, week 24, and week 44|This analysis was as-treated, limited to participants who had data for baseline, week 20, week 24, and week 44, and remained on study treatment through week 44 (allowing treatment interruption < 4 weeks), and did not use prohibited medications or have virologic failure during the course of the study.||log10 pg/ml||Inter-Quartile Range|Median
698875|NCT01351025|Secondary|Difference Between [Change From Week 24 to Week 44] and Change From [Baseline to Week 20] in MCP-1 (log10 Transformed)|"Monocyte chemoattractant protein-1 (MCP-1/CCL2) is one of the key chemokines that regulate migration and infiltration of monocytes/macrophages.
Difference between [change from week 24 to week 44] and change from [baseline to week 20] is defined as [week 44 - week 24] - [week 20 - baseline]."|baseline, week 20, week 24, and week 44|This analysis was as-treated, limited to participants who had data for baseline, week 20, week 24, and week 44, and remained on study treatment through week 44 (allowing treatment interruption < 4 weeks), and did not use prohibited medications or have virologic failure during the course of the study.||log10 pg/ml||Inter-Quartile Range|Median
698876|NCT01351025|Primary|Difference Between [Change From Week 24 to Week 44] and [Change From Baseline to Week 20] in CD8+ T-cell Activation Percent|CD8+ T-cell activation percent (% CD38+/DR+ of CD8+): Difference between [change from week 24 to week 44] and [change from baseline to week 20] (i.e. [week 44 - week 24] - [week 20 - baseline])|baseline, week 20, week 24, and week 44|The primary analysis was as-treated, limited to participants who had data for baseline, week 20, week 24, and week 44, and remained on study treatment through week 44 (allowing treatment interruption < 4 weeks), and did not use prohibited medications or have virologic failure during the course of the study.||percent||Inter-Quartile Range|Median
698877|NCT01351025|Primary|Difference Between [Change From Week 24 to Week 44] and [Change From Baseline to Week 20] in log10 D-dimer|D-dimer in log10 ng/mL: Difference between [change from week 24 to week 44] and [change from baseline to week 20] (i.e. [week 44 - week 24] - [week 20 - baseline])|baseline, week 20, week 24, and week 44|The primary analysis was as-treated, limited to participants who had data for baseline, week 20, week 24, and week 44, and remained on study treatment through week 44 (allowing treatment interruption < 4 weeks), and did not use prohibited medications or have virologic failure during the course of the study.||log10 ng/mL||Inter-Quartile Range|Median
698878|NCT01351025|Primary|Difference Between [Change From Week 24 to Week 44] and [Change From Baseline to Week 20] in CD4+ T-cell Activation Percent|CD4+ T-cell activation percent (% CD38+/DR+ of CD4+): Difference between [change from week 24 to week 44] and [change from baseline to week 20] (i.e. [week 44 - week 24] - [week 20 - baseline])|baseline, week 20, week 24, and week 44|The primary analysis was as-treated, limited to participants who had data for baseline, week 20, week 24, and week 44, and remained on study treatment through week 44 (allowing treatment interruption < 4 weeks), and did not use prohibited medications or have virologic failure during the course of the study.||percent||Inter-Quartile Range|Median
698879|NCT01351025|Primary|Difference Between [Change From Week 24 to Week 44] and [Change From Baseline to Week 20] in log10 IL-6|IL-6 (Interleukin 6) in log10 pg/mL: Difference between [change from week 24 to week 44] and [change from baseline to week 20] (i.e. [week 44 - week 24] - [week 20 - baseline])|baseline, week 20, week 24, and week 44|The primary analysis was as-treated, limited to participants who had data for baseline, week 20, week 24, and week 44, and remained on study treatment through week 44 (allowing treatment interruption < 4 weeks), and did not use prohibited medications or have virologic failure during the course of the study.||log10 pg/mL||Inter-Quartile Range|Median
698880|NCT01350999|Secondary|Percent Change From Baseline in Non-High-Density Lipoprotein - Cholesterol|Non-high-density lipoprotein cholesterol was calculated by subtracting high-density lipoprotein cholesterol from total cholesterol.|Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|"Full analysis set with available data at each time point (indicated by n)."||percent change||Standard Deviation|Mean
698881|NCT01350999|Secondary|Percent Change From Baseline in High-Density Lipoprotein - Cholesterol (HDL-C)||Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|"Full analysis set with available data at each time point (indicated by n)."||percent change||Standard Deviation|Mean
698882|NCT01350999|Secondary|Percent Change From Baseline in Total Cholesterol||Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|"Full analysis set with available data at each time point (indicated by n)."||percent change||Standard Deviation|Mean
698883|NCT01350999|Secondary|Percent Change From Baseline in Low-Density Lipoprotein - Cholesterol (LDL-C)||Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|"Full analysis set with available data at each time point (indicated by n)."||percent change||Standard Deviation|Mean
698884|NCT01350999|Secondary|Percent Change From Baseline in Triglyceride Level||Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|"Full analysis set (all participants who were randomized and received at least one dose of the investigational product) with available data at each time point (indicated by n)."||percent change||Standard Deviation|Mean
698885|NCT01350999|Primary|Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis||52 Weeks|Safety Analysis Set included all participants who received at least one dose of the investigational product.||participants|||Number
698886|NCT01350999|Primary|Number of Participants With Clinically Significant Findings in Electrocardiogram After Study Drug Administration|Participants whose results of electrocardiograms were judged as abnormal and clinically significant by investigator after study drug administration were counted in this measure.|52 Weeks|Safety Analysis Set included all participants who received at least one dose of the investigational product.||participants|||Number
698887|NCT01350999|Primary|Number of Participants With TEAEs Associated With Abnormal Changes in Body Weight||52 Weeks|Safety Analysis Set included all participants who received at least one dose of the investigational product.||participants|||Number
698888|NCT01350999|Primary|Number of Participants With TEAEs Associated With Abnormal Changes in Vital Signs||52 Weeks|Safety Analysis Set included all participants who received at least one dose of the investigational product.||participants|||Number
698897|NCT01350973|Secondary|Percent Change From Baseline in Low-Density Lipoprotein - Cholesterol (LDL-C) Level Over Time|The percentage change between low-density lipoprotein cholesterol collected at each study visit relative to Baseline. Low-density lipoprotein cholesterol particles measured directly by nuclear magnetic resonance.|Baseline and Weeks 4, 8, 10 and 12|"Full analysis set with available data at each time point (indicated by n)."||percent change||Standard Deviation|Mean
698898|NCT01350973|Secondary|Percent Change From Baseline in Triglyceride Level Over Time|The percentage change between triglycerides collected at each study visit relative to Baseline.|Baseline and Weeks 4, 8, 10 and 12|"Full analysis set with available data at each time point (indicated by n)."||percent change||Standard Deviation|Mean
698899|NCT01350973|Primary|Percent Change From Baseline in Triglyceride Level at the Final Visit|The percentage change between triglycerides collected at the end of study drug administration (the end of treatment period or discontinuation) relative to Baseline. Analysis of Covariance (ANCOVA) model was employed, using the Baseline triglyceride level as covariate and the treatment group as an independent variable.|Baseline and 12 weeks|Full analysis set including all participants who were randomized and received at least one dose of the investigational product and with available data.||percent change||Standard Error|Least Squares Mean
698900|NCT01350947|Primary|Percentage of Patients With Complete Hematologic Response (According to IWG 2006 Criteria) in CMML Patients Treated With 5-azacitidine.|Complete Hematologic Response is defined as: bone marrow evaluation shows <= 5% myeloblasts with normal maturation of all cells lines; peripheral blood evaluation shows hemoglobin >= 11 g/dL, neutrophils >= 1000/mL, platelets >= 100,000/mL, 0% blasts|24 months|||percentage of patients|||Number
698908|NCT01350804|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR) - Observed Data|Blood samples were obtained to monitor disease activity and response to treatment. A negative change from baseline indicates improvement. The ESR results from baseline up to week 52 were based on observed data, i.e. without imputation.|baseline, weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|Participants from the full analysis set were considered for the analysis. Participants with measurements at both baseline and each post-baseline time point were analyzed for that post-baseline time point. The full analysis set was comprised of all randomized participants (excluding mis-randomized participants) who were assigned to study treatment.||mm/hr||Standard Deviation|Mean
698979|NCT01349959|Other Pre-specified|Feasibility of the Addition of Hormone Therapy, Evaluated by Calculating the Percentage of Patients With Disease Progression That go on to Receive Hormonal Therapy||Up to 3 years||||||
698909|NCT01350804|Secondary|Change From Baseline in hsCRP - Observed Data|Blood samples were obtained to identify the presence of inflammation, to determine its severity and to monitor response to treatment. A negative change from baseline indicates improvement. The hsCRP results from baseline up to week 52 were based on observed data, i.e. without imputation.|baseline, weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|Participants from the full analysis set were considered for the analysis. Participants with measurements at both baseline and each post-baseline time point were analyzed for that post-baseline time point. The full analysis set was comprised of all randomized participants (excluding mis-randomized participants) who were assigned to study treatment.||mg/L||Standard Deviation|Mean
698910|NCT01350804|Secondary|Change From Baseline in Disease Activity Score Utilizing CRP (DAS28-CRP) - Observed Data|The DAS28 is a measure of disease activity in RA based on Swollen and Tender Joint Counts (out of a total of 28), hsCRP and the Patient’s Global Assessment of Disease Activity. A DAS28 score greater than 5.1 implies active disease, equal to or less than 3.2 low disease activity, and less than 2.6 remission. A negative change from baseline indicates improvement. The DAS28-CRP results from baseline up to week 52 were based on observed data, i.e. without imputation.|baseline, weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52|Participants from the full analysis set were considered for the analysis. Participants with measurements at both baseline and each post-baseline time point were analyzed for that post-baseline time point. The full analysis set was comprised of all randomized participants (excluding mis-randomized participants) who were assigned to study treatment.||score on a scale||Standard Deviation|Mean
698911|NCT01350804|Secondary|Change From Baseline in Disease Activity Score Utilizing CRP (DAS28-CRP) - Using MMRM|The DAS28 is a measure of disease activity in RA based on Swollen and Tender Joint Counts (out of a total of 28), hsCRP and the Patient’s Global Assessment of Disease Activity. A DAS28 score greater than 5.1 implies active disease, equal to or less than 3.2 low disease activity, and less than 2.6 remission. A negative change from baseline indicates improvement.|baseline, weeks 1, 2, 4, 8, 12, 16, 20 and 24|Participants from the full analysis set were considered for the analysis. For Placebo and Abatacept participants, data collected after treatment switch was treated as missing, as were missing values for all treatment groups||score on a scale||Standard Error|Least Squares Mean
698912|NCT01350804|Secondary|Change From Baseline in HAQ-DI - Observed Data|"The HAQ-DI assesses a subject's level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities. There are 20 questions in 8 categories of functioning including dressing, rising, eating, walking, hygiene, reach, grip and usual activities. The stem of each item asks 'Over the past week, are you able to... perform a particular task'. Each item is scored on a 4 point scale from 0 - 3, representing normal, no difficulty (0), some difficulty (1), much difficulty (2) and unable to do (3). The disability index score is calculated as the mean of the available category scores, ranging from 0 to 3. A negative change from baseline indicates improvement. The HAQ-DI results from baseline up to week 52 were based on observed data, i.e. without imputation."|baseline, weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52|Participants from the full analysis set were considered for the analysis. Participants with measurements at both baseline and each post-baseline time point were analyzed for that post-baseline time point. The full analysis set was comprised of all randomized participants (excluding mis-randomized participants) who were assigned to study treatment.||score on a scale||Standard Deviation|Mean
698913|NCT01350804|Secondary|Change From Baseline in HAQ-DI - Using Mixed Model Repeated Measures (MMRM)|"The HAQ-DI, assesses a subject's level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities. There are 20 questions in 8 categories of functioning including dressing, rising, eating, walking, hygiene, reach, grip and usual activities. The stem of each item asks 'Over the past week, are you able to... perform a particular task'. Each item is scored on a 4 point scale from 0 - 3, representing normal, no difficulty (0), some difficulty (1), much difficulty (2) and unable to do (3). The disability index score is calculated as the mean of the available category scores, ranging from 0 to 3. A negative change from baseline indicates improvement."|baseline, weeks 1, 2, 4, 8, 12, 16, 20 and 24|Participants from the full analysis set were considered for this analysis. For Placebo and Abatacept participants, data collected after treatment switch was treated as missing, as were missing values for all treatment groups.||score on a scale||Standard Error|Least Squares Mean
698914|NCT01350804|Secondary|Percentage of Participants Achieving ACR20, ACR 50 and ACR 70 - Observed Data|ACR20, ACR 50 and ACR 70 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 20%, 50% and/or 70% improvement, respectively, in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient’s assessment of RA pain, patient’s global assessment of disease activity, physician’s global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire [HAQ-DI] score), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR). The ACR20, ACR50 and ACR70 response results from baseline up to week 52 were based on observed data, i.e. without imputation.|baseline, weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52|Participants from the full analysis set were considered for the analysis. Participants with measurements at both baseline and each post-baseline time point were analyzed for that post-baseline time point. The full analysis set was comprised of all randomized participants (excluding mis-randomized participants) who were assigned to study treatment.||Percentage of participants|||Number
698915|NCT01350804|Secondary|Percentage of Participants Achieving ACR20, ACR 50 and ACR 70 - Using Non-responder Imputation|ACR20, ACR 50 and ACR 70 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 20%, 50% and/or 70% improvement, respectively, in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient’s assessment of RA pain, patient’s global assessment of disease activity, physician’s global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire [HAQ-DI] score), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR).|baseline, weeks 1, 2, 4, 8, 12, 16, 20 and 24|Participants from the full analysis set were considered for the analysis. Participants with missing data were considered non-responders at the respective time point. Placebo and Abatacept participants were considered non-responders from the time of treatment switch.||Percentage of participants|||Number
698916|NCT01350804|Secondary|Percentage of Participants Achieving ACR50|ACR50 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 50% improvement in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient’s assessment of RA pain, patient’s global assessment of disease activity, physician’s global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire [HAQ-DI] score), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR). The ACR50 response results at week 24 used non-responder imputation.|week 24|Full analysis set: the full analysis set was comprised of all randomized participants (excluding mis-randomized participants) who were assigned to study treatment.||Percentage of participants|||Number
698917|NCT01350804|Secondary|Change From Baseline in Stanford Health Assessment Questionnaire Disability Index (HAQ-DI)|"The HAQ-DI assesses a subject's level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities. There are 20 questions in 8 categories of functioning including dressing, rising, eating, walking, hygiene, reach, grip and usual activities. The stem of each item asks 'Over the past week, are you able to... perform a particular task'. Each item is scored on a 4 point scale from 0 - 3, representing normal, no difficulty (0), some difficulty (1), much difficulty (2) and unable to do (3). The disability index score is calculated as the mean of the available category scores, ranging from 0 to 3. A negative change from baseline indicates improvement."|baseline, week 24|Participants from the full analysis set were considered for the analysis. Participants with measurements at both baseline and week 24 were analyzed. The full analysis set was comprised of all randomized participants (excluding mis-randomized participants) who were assigned to study treatment.||score on a scale||Standard Error|Least Squares Mean
698918|NCT01350804|Secondary|Change From Baseline in Disease Activity Score Utilizing CRP (DAS28-CRP)|The DAS28 is a measure of disease activity in RA based on Swollen and Tender Joint Counts (out of a total of 28), hsCRP and the Patient’s Global Assessment of Disease Activity. A DAS28 score greater than 5.1 implies active disease, equal to or less than 3.2 low disease activity, and less than 2.6 remission. A negative change from baseline indicates improvement.|baseline, week 24|Participants from the full analysis set were considered for the analysis. Participants with measurements at both baseline and week 24 were analyzed. The full analysis set was comprised of all randomized participants (excluding mis-randomized participants) who were assigned to study treatment.||score on a scale||Standard Error|Least Squares Mean
698919|NCT01350804|Primary|Percentage of Participants Achieving an American College of Rheumatology Response 20 (ACR20).|ACR20 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 20% improvement in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient’s assessment of RA pain, patient’s global assessment of disease activity, physician’s global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire [HAQ-DI] score), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR). The ACR20 response results at week 24 used non-responder imputation.|week 24|Full analysis set: the full analysis set was comprised of all randomized participants (excluding mis-randomized participants) who were assigned to study treatment.||Percentage of participants|||Number
698920|NCT01350583|Secondary|Number of Participants With Improvement in Pain Indices|Improvement in pain indices (Memorial Symptom Assessment Scale, MSAS) and Brief Pain Inventory (BPI).|4 weeks per participant|Results data was not tabulated due to low accrual. Outcome Measures were based on 25 evaluable participants. That goal was not reached.|||||
698921|NCT01350583|Secondary|Percent of Patients Where Treatment Was Well Tolerated|Tolerability and safety of oral sodium bicarbonate in patients with moderate to severe tumor related pain|4 weeks per participant|Results data was not tabulated due to low accrual. Outcome Measures were based on 25 evaluable participants. That goal was not reached.|||||
698922|NCT01350583|Primary|Percent of Patients With Improvement|Percent of patients with greater than 30% improvement in pain intensity by visual assessment scale.|4 weeks per participant|Results data was not calculated due to low accrual. Outcome Measures were based on 25 evaluable participants. That goal was not reached.|||||
698923|NCT01350544|Primary|Medication Adherence|We used a repeated measures linear regression modeling continuous adherence with intervention, linear time, and their interaction, and demographic covariates. Continuous adherence is measured as average percentages of doses taken.|Baseline, 1.5 months, 3 months, 4.5 months, and 6 months|||Percentage of doses taken||Standard Deviation|Mean
698924|NCT01350479|Primary|MRSA Transmission|Presence of MRSA on gown or gloves worn by enrolled health care worker for research purposes while providing a specific type of care for enrolled resident|Will be measured during 6-25 episodes of care interactions scheduled over the 30 days following resident enrollment|We analyzed the number of gown and glove swabs from HCW interacting with MRSA and non-MRSA colonized residents.||Proportion of swabs positive for MRSA|swabs||Number
698925|NCT01350414|Secondary|Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)|Post-Bronchodilator FEV1 (% Predicted) percentage changes from Baseline to the Year 1, Year 2, Year 3, Year 4, and Year 5.|12 Month periods out to 5 years|Number of Subjects Completing Follow-up. 181 subjects completed 12 month follow-up; 165 subjects completed Year 2 follow-up; 162 subjects completed Year 3 follow-up; 159 subjects completed Year 4 follow-up; and 162 subjects completed Year 5 follow-up.||Percentage of change from Baseline||Standard Deviation|Mean
698926|NCT01350414|Secondary|Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)|Pre-Bronchodilator FEV1 (% Predicted) percentage changes from Baseline to the Year 1, Year 2, Year 3, Year 4, and Year 5.|12 Month periods out to 5 years|Number of Subjects Completing Follow-up. 181 subjects completed 12 month follow-up; 165 subjects completed Year 2 follow-up; 162 subjects completed Year 3 follow-up; 159 subjects completed Year 4 follow-up; and 162 subjects completed Year 5 follow-up.||Percentage of change from Baseline||Standard Deviation|Mean
698927|NCT01350414|Secondary|Hospitalizations for Respiratory Symptoms|Number of Hospitalizations for Respiratory Symptoms per subject per year.|12 Month periods out to 5 years|Number of Subjects Completing Follow-up. 181 subjects completed 12 month follow-up; 165 subjects completed Year 2 follow-up; 162 subjects completed Year 3 follow-up; 159 subjects completed Year 4 follow-up; and 162 subjects completed Year 5 follow-up.||Number of events/subjects/year||95% Confidence Interval|Number
698928|NCT01350414|Secondary|Hospitalizations for Respiratory Symptoms|Proportion of subjects with hospitalizations for respiratory symptoms.|12 Month periods out to 5 Years|Number of Subjects Completing Follow-up. 181 subjects completed 12 month follow-up; 165 subjects completed Year 2 follow-up; 162 subjects completed Year 3 follow-up; 159 subjects completed Year 4 follow-up; and 162 subjects completed Year 5 follow-up.||Percentage of subjects hospitalized||95% Confidence Interval|Number
698929|NCT01350414|Secondary|Emergency Room (ER) Visits for Respiratory Symptoms|Number of Emergency Room Visits for Respiratory Symptoms per subject per year.|12 Month periods out to 5 years|Number of Subjects Completing Follow-up. 181 subjects completed 12 month follow-up; 165 subjects completed Year 2 follow-up; 162 subjects completed Year 3 follow-up; 159 subjects completed Year 4 follow-up; and 162 subjects completed Year 5 follow-up.||Number of events/subject/year||95% Confidence Interval|Number
698930|NCT01350414|Secondary|Emergency Room Visits for Respiratory Symptoms|Proportion of Subjects with Emergency Room Visits for Respiratory Symptoms|12 Month periods out to 5 years|Number of Subjects Completing Follow-up. 181 subjects completed 12 month follow-up; 165 subjects completed Year 2 follow-up; 162 subjects completed Year 3 follow-up; 159 subjects completed Year 4 follow-up; and 162 subjects completed Year 5 follow-up.||Percentage subjects ER respir. symptoms||95% Confidence Interval|Number
698931|NCT01350414|Secondary|Respiratory Adverse Events|Proportion of subjects experiencing one or more respiratory adverse event in each of the years 1 through 5 following the Alair treatment. A respiratory adverse event is defined as any sign, symptom, illness, clinically significant abnormal laboratory value, or other adverse medical event associated with the “Respiratory System” that appears or worsens in a subject during a clinical study, regardless of whether or not it is considered related to the procedure used as part of the protocol.|12 Month periods out to 5 years|Number of Subjects Completing Follow-up. 181 subjects completed 12 month follow-up; 165 subjects completed Year 2 follow-up; 162 subjects completed Year 3 follow-up; 159 subjects completed Year 4 follow-up; and 162 subjects completed Year 5 follow-up.||Percentage subjects with respiratory AE||95% Confidence Interval|Number
698932|NCT01350414|Secondary|Respiratory Adverse Events|Number of respiratory adverse events per subject per year. A respiratory adverse event is defined as any sign, symptom, illness, clinically significant abnormal laboratory value, or other adverse medical event associated with the “Respiratory System” that appears or worsens in a subject during a clinical study, regardless of whether or not it is considered related to the procedure used as part of the protocol.|12 Month periods out to 5 years|Number of Subjects Completing Follow-up. 181 subjects completed 12 month follow-up; 165 subjects completed Year 2 follow-up; 162 subjects completed Year 3 follow-up; 159 subjects completed Year 4 follow-up; and 162 subjects completed Year 5 follow-up.||Number of events/number of subject/Year||95% Confidence Interval|Number
698933|NCT01350414|Secondary|Severe Exacerbations|Number of severe exacerbations per subject per year. Severe exacerbation is defined as treatment with oral or intravenous corticosteroids, OR a doubling of the baseline inhaled corticosteroid dose for at least 3 days, OR any temporary increase in the dosage of oral corticosteroids for a subject taking maintenance oral corticosteroids at entry into the AIR2 Trial (Protocol #04-02).|12 Month periods out to 5 years|Number of Subjects Completing Follow-up. 181 subjects completed 12 month follow-up; 165 subjects completed Year 2 follow-up; 162 subjects completed Year 3 follow-up; 159 subjects completed Year 4 follow-up; and 162 subjects completed Year 5 follow-up.||Number of events/Number of subjects/Year||95% Confidence Interval|Number
698934|NCT01350414|Primary|Severe Exacerbations|"The primary endpoint will be the proportion of subjects experiencing severe exacerbations during the first year after the Alair treatment compared to subsequent 12-month periods out to 5 years. This objective will be met if the upper 95% confidence limit of the difference in proportions (i.e., the subsequent 12-month proportion minus the first 12-month proportion) is less than 20%.
Severe exacerbation is defined as treatment with oral or intravenous corticosteroids, OR a doubling of the baseline inhaled corticosteroid dose for at least 3 days, OR any temporary increase in the dosage of oral corticosteroids for a subject taking maintenance oral corticosteroids at entry into the AIR2 Trial (Protocol #04-02)."|12 month periods out to 5 Years|Number of Subjects Completing Follow-up. 181 subjects completed 12 month follow-up; 165 subjects completed Year 2 follow-up; 162 subjects completed Year 3 follow-up; 159 subjects completed Year 4 follow-up; and 162 subjects completed Year 5 follow-up.||Percentage subjects severe exacerbations||95% Confidence Interval|Number
698935|NCT01350388|Secondary|Change in High Sensitivity C-Reactive Protein (hsCRP) Concentration in Plasma From Baseline to 24 Weeks|The percent difference in plasma hsCRP concentration geometric mean values from baseline to 24 weeks was calculated for each arm|Baseline and 24 weeks|||percent difference in geometric mean||95% Confidence Interval|Geometric Mean
698936|NCT01350388|Secondary|Change in Interleukin-6 (IL-6) Concentration in Plasma From Baseline to 24 Weeks|The percent difference in plasma IL-6 concentration geometric mean values from baseline to 24 weeks was calculated for each arm|Baseline and 24 weeks|||percent difference in geometric mean||95% Confidence Interval|Geometric Mean
698937|NCT01350388|Secondary|Change in Tumor Necrosis Factor-α (TNF-α) Concentration in Plasma From Baseline to 24 Weeks|The percent difference in plasma TNF-α concentration geometric mean values from baseline to 24 weeks was calculated for each arm|Baseline and 24 weeks|||percent difference in geometric mean||95% Confidence Interval|Geometric Mean
698938|NCT01350388|Primary|Change in Urinary Concentrations of Transforming Growth Factor-beta1 (TGF-beta1) From Baseline to 24 Weeks|The percent difference in TGF-beta1 concentration geometric mean values from baseline to 24 weeks was calculated for each arm|Baseline and 24 weeks|||percent difference in geometric mean||95% Confidence Interval|Geometric Mean
698939|NCT01350388|Primary|Change in Adiponectin Concentration in Adipose Tissue From Baseline to 24 Weeks|The percent difference in adiponectin concentration geometric mean values from baseline to 24 weeks was calculated for each arm|Baseline and 24 weeks|||percent difference in geometric mean||95% Confidence Interval|Geometric Mean
698940|NCT01350388|Primary|Change in Thiobarbituric Acid Reactive Substance (TBARS) Concentration in Adipose Tissue From Baseline to 24 Weeks|The percent difference in thiobarbituric acid reactive substance (TBARS) concentration geometric mean values from baseline to 24 weeks was calculated for each arm|Baseline and 24 weeks|||percent difference in geometric mean||95% Confidence Interval|Geometric Mean
698980|NCT01349959|Other Pre-specified|Confirmed Response Rate to Azacitidine and Entinostat Plus the Addition of Hormone Therapy|Will be estimated in each cohort. All evaluable patients who receive hormonal therapy will be used for this analysis.|Up to 3 years||||||
698941|NCT01350271|Secondary|Faecal Egg Count Reduction 2 (FECR2)|FECR2=〈Arithmetic mean {[(pretreatment egg count)-(posttreatment egg count)]÷(pretreatment egg count)}〉×100|Two weeks|All participants who were hookworm positive at baseline, and who provided a faecal sample for examination at follow up were included in the analysis||percentage of eggs excreted||Standard Deviation|Mean
698942|NCT01350271|Secondary|Faecal Egg Count Reduction 1 (FECR1)|FECR1= {[(Arithmetic mean of pretreatment egg counts)-(arithmetic mean of posttreatment egg counts)]÷(arithmetic mean of pretreatment egg counts)}×100|Two weeks|All participants who were hookworm positive at baseline, and who provided a faecal sample for examination at follow-up, were included in the analysis||percentage of eggs excreted|||Number
698943|NCT01350271|Primary|Cure Rate|Cure rate={(Number positive pretreatment - Number positive posttreatment)÷(Number positive pretreatment)}×100|Two weeks|All participants who were hookworm positive at baseline, and who provided a faecal sample for examination at follow up.||percentage of participants|||Number
698944|NCT01350258|Secondary|Overall Survival|To assess overall survival in patients undergoing HSCT treated on this trial.|At 1 and 3 years||||||
698945|NCT01350258|Secondary|Engraftment Rate and Lymphoid Reconstitution|To evaluate engraftment rates and lymphoid reconstitution in patients treated on this trial.|100 days post-transplant||||||
698946|NCT01350258|Secondary|GVHD Incidence and Severity|To determine the incidence and severity of graft-versus-host disease (GVHD) in patients undergoing treatment on this regimen using MEL for T cell tolerization as well as tacrolimus and mycophenolate mofetil (MMF) as GVHD prophylaxis.|At 1 and 3 years||||||
698947|NCT01350258|Secondary|Relapse Rate|To compare relapse rates in patients undergoing HSCT treated on this successor TJU 2 Step RIC haploidentical regimen and compare it with that of the initial regimen.|At 1 and 3 years||||||
698948|NCT01350258|Primary|Phase 2: Non-Relapse Mortality (NRM)|To evaluate the 100 day non-relapse mortality (NRM) rate in patients undergoing HSCT treated on this successor TJU 2 Step RIC haploidentical regimen and compare it with that of the initial regimen.|100 days post-treatment||||||
698949|NCT01350258|Primary|Phase 1: Defined Dose of Melphalan (MEL)|To define the dose of MEL required for the establishment of peripheral T cell tolerance with concomitant immune reconstitution.|100 days post-transplant||||||
698950|NCT01350245|Primary|Probability of Overall Survival at 15 Months Post-treatment|Probability of overall survival at 15 months post-treatment, defined as success if a patient is alive 1-year post-transplant.|15 months|||percentage of probability|||Number
698951|NCT01350245|Primary|Disease-Free Survival (DFS)|1-year post-transplant disease free survival (DFS), defined as success if a patient is alive and disease free at 1-year post-transplant.|1 year post-transplant|||percentage of patients|||Number
698952|NCT01350232|Secondary|Cytokine Profile|To characterize the profiles of cytokines released following administration of the lymphoid portion of the transplant (donor lymphocyte infusion [DLI]).|Through 5 years after infusion||||||
698953|NCT01350232|Secondary|Quality of Life|To describe the quality of life and functional status following transplantation.|Through 5 years post infusion||||||
698954|NCT01350232|Secondary|Immune Recovery|To assess the pace of lymphoid recovery and associated risk for opportunistic infections and relapse (return to recipient erythropoiesis) in this patient population.|100 days post infusion through 5 years post infusion||||||
698955|NCT01350232|Secondary|Correction of Hemoglobinopathy|To evaluate the extent of correction of hemoglobinopathy following this reduced intensity transplant.|100 days post infusion through 5 years post infusion||||||
698956|NCT01350232|Secondary|Acute Graft Versus Host Disease|To describe the incidence and severity of acute and chronic GVHD following this reduced intensity transplant from partially matched related donors using a combination of cyclophosphamide, tacrolimus and mycophenolate mofetil (MMF) as GVHD prophylaxis.|100 days post infusion||||||
698957|NCT01350232|Secondary|Overall Survival|To determine the overall survival at 6 months post-transplant in patients receiving a matched or partially-matched related donor transplant after reduced-intensity conditioning.|6 months post infusion||||||
698958|NCT01350232|Secondary|Organ Toxicity|To assess organ toxicity related to fludarabine, cytarabine, cyclophosphamide and low-dose total body irradiation in a population with severe sickle cell anemia.|30 days post infusion||||||
698959|NCT01350232|Primary|Stable Engraftment|To determine if the reduced intensity preparative regimen of fludarabine, cytarabine, cyclophosphamide and low-dose total body irradiation will generate stable engraftment with donor hematopoietic stem cells in at least 80% of patients with severe sickle cell anemia.|180 days post-infusion||||||
698960|NCT01350128|Secondary|Change From Baseline in 12-hour Post-dose Trough FEV1 on Day 7|Change from baseline in 12-hour post-dose trough FEV1|Day 7|MITT Population includes subjects who completed at least 2 treatment periods, with minimally 1 pre-dose assessment on Day 7 for each of those 2 treatment periods with no protocol deviations believed to have a potential impact on efficacy results.||Liters||95% Confidence Interval|Least Squares Mean
698961|NCT01350128|Secondary|Peak Change From Baseline in IC on Day 7|Peak change from baseline in IC|Day 7|MITT Population includes subjects who completed at least 2 treatment periods, with minimally 1 pre-dose assessment on Day 7 for each of those 2 treatment periods with no protocol deviations believed to have a potential impact on efficacy results.||Liters||95% Confidence Interval|Least Squares Mean
698962|NCT01350128|Secondary|Peak Change From Baseline in FEV1 on Day 7|Peak change from baseline in FEV1|Day 7|MITT Population includes subjects who completed at least 2 treatment periods, with minimally 1 pre-dose assessment on Day 7 for each of those 2 treatment periods with no protocol deviations believed to have a potential impact on efficacy results.||Liter||95% Confidence Interval|Least Squares Mean
698963|NCT01350128|Secondary|Change From Baseline in Morning Pre-dose FEV1 on Day 7|Change from baseline in morning pre-dose FEV1|Day 7|MITT Population includes subjects who completed at least 2 treatment periods, with minimally 1 pre-dose assessment on Day 7 for each of those 2 treatment periods with no protocol deviations believed to have a potential impact on efficacy results.||Liter||95% Confidence Interval|Least Squares Mean
698964|NCT01350128|Secondary|Peak Change From Baseline in IC on Day 1|Peak change from baseline in Inspiratory Capacity (IC) on Day 1 (mean of 1 and 2 hours post-dose minus baseline on Day 1)|Day 1|MITT Population includes subjects who completed at least 2 treatment periods, with minimally 1 pre-dose assessment on Day 7 for each of those 2 treatment periods with no protocol deviations believed to have a potential impact on efficacy results.||Liter||95% Confidence Interval|Least Squares Mean
698965|NCT01350128|Secondary|Proportion of Subjects Achieving at Least 12% Improvement in FEV1 on Day 1|Proportion of subjects achieving at least 12% improvement in FEV1 (relative to baseline)|Day 1|MITT Population: This includes subjects who completed at least 2 treatment periods, with minimally 1 pre-dose assessment on Day 7 for each of those 2 treatment periods with no protocol deviations believed to have a potential impact on efficacy results.||Percent|||Number
698966|NCT01350128|Secondary|Time to Onset of Action ( ≥10% Improvement in FEV1) on Day 1|Time to onset of action ( ≥10% improvement in FEV1)|Day 1 (15 min, 30 min, 1 hour, 2 hours)|MITT Population includes subjects who completed at least 2 treatment periods, with minimally 1 pre-dose assessment on Day 7 for each of those 2 treatment periods with no protocol deviations believed to have a potential impact on efficacy results.||% of subjects|||Number
698967|NCT01350128|Secondary|Peak Change From Baseline in FEV1 on Day 1|Highest value of FEV1 post-dose minus baseline on Day 1 (baseline-adjusted)|Day 1|MITT Population includes subjects who completed at least 2 treatment periods, with minimally 1 pre-dose assessment on Day 7 for each of those 2 treatment periods with no protocol deviations believed to have a potential impact on efficacy results.||Liter||95% Confidence Interval|Least Squares Mean
698968|NCT01350128|Primary|FEV1 AUC0-12|FEV1 AUC0-12 following chronic dosing (1 week), normalized.|Day 7 ( -1 hour, -30 min, 15 min, 30 min, 1 hour, 2 hours, 4 hours, 5.5 hours, 6.5 hours, 8 hours, 10 hours, 11.5 hours, and 12 hours)|Modified Intent to Treat (MITT) Population includes subjects who completed at least 2 treatment periods, with minimally 1 pre-dose assessment on Day 7 for each of those 2 treatment periods with no protocol deviations believed to have a potential impact on efficacy results.||Liter||95% Confidence Interval|Least Squares Mean
698969|NCT01350115|Secondary|Measure: Disease Burden by BCC Tumor Counts|BCC tumor counts were performed separately for five body regions: head and neck, trunk back, trunk front (including axillae and groin), upper extremities and lower extremities (including buttocks). During the counting, the BCC tumors, were categorized upon inspection by their longest diameter measurement (<10 mm, 10-19 mm, 20-29 mm, and >+30mm), and also by the type of BCC (superficial, nodular, other). The counts for all of the BCC type and size categories were determined (or estimated if many small lesions) for each body region. The body region counts were summated to provide the overall BCC tumor count.|Baseline, day 85, and day 113|All participants, who had evaluable (or complete) pharmacodynamic (PD) or biomarker parameter data and were without protocol deviations with significant impact on the PD data, were included in the PD analysis set.||Number of BCC tumors|||Number
698970|NCT01350115|Secondary|Histological Clearance Assessment of Main Target BCCs|The main (and secondary, if appropriate) target BCC tumor area(s) was/were excised surgically and sent to a central laboratory for histological examination.|day 113|All participants, who had evaluable (or complete) pharmacodynamic (PD) or biomarker parameter data and were without protocol deviations with significant impact on the PD data, were included in the PD analysis set.||Percentage of participants|||Number
698971|NCT01350115|Primary|Clinical Clearance Assessment of Main Target Basal Cell Carcinomas (BCCs)|The clinical response of the main target (and secondary target, as appropriate) BCC(s) to treatment was evaluated using the following 6-point scale comparing the assessment at the visit to the clinical presentation at Baseline: 0 = Worsening, 1 = No change, 2 = Slight clearance (1-25% improvement), 3 = Moderate clearance (26-75% improvement), 4 = Marked clearance (76-99% improvement),5 = Complete clearance (100% improvement) Complete clearance was defined as no clinical residual signs of carcinoma, as evaluated by the Investigator at a post-Baseline visit, with the exception of post-inflammatory changes such as minimal residual erythema or residual hyper-pigmentation or hypo-pigmentation or residual scarring.|Day 113|All participants, who had evaluable (or complete) pharmacodynamic (PD) or biomarker parameter data and were without protocol deviations with significant impact on the PD data, were included in the PD analysis set.||Participants|||Number
698972|NCT01349972|Secondary|Progression-free Survival|Probabilities will be estimated with the Kaplan-Meier estimate. Survival estimates at two years will be estimated.|4 years|||years||95% Confidence Interval|Median
698973|NCT01349972|Secondary|Number of Patients With Minimal Residual Disease|Comparisons of the treatments with respect to MRD will be based on the number of patients with MRD at day 14 after the start of treatment.|From study start to 14 days after the start of treatment|||Participants|||Count of Participants
698974|NCT01349972|Secondary|Overall Survival|Probabilities will be estimated with the Kaplan-Meier estimate. Survival estimates at two years will be estimated.|4 years|||years||95% Confidence Interval|Median
698975|NCT01349972|Secondary|Disease-free Survival|Probabilities will be estimated with the Kaplan-Meier estimate. Survival estimates at two years will be estimated. Disease-free survival Overall survival was defined from date of randomization to death or last known follow-up. Event free survival was defined as date of randomization to the first occurrence of persistent AML after 1 cycle of induction, relapse or death. Patients were censored for event free survival if they had received non-protocol therapy or a stem cell transplant.|Time from randomization until death from any cause or relapse or recurrence, assessed up to 2 years|||years||Full Range|Median
698976|NCT01349972|Secondary|Incidence of Toxicities, Characterized by Number of Events by Treatment and Grade|The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.|Up to 14 days after completion of study treatment|Number of evaluable subjects||Number of events|||Number
698977|NCT01349972|Primary|Complete Response Rate|Bone marrow showing less than 5% myeloblasts with normal maturation of all cell lines, an ANC of at least 1000/cu mm and a platelet count of 100,000/cu mm, absence of blast in peripheral blood, absence of identifiable leukemic cells in the bone marrow, clearance of disease-associated cytogenetic abnormalities, and clearance of any previously existing extramedullary disease. These criteria are taken from Dohner H, Estey EH, Amadori S, et al. Diagnosis and management of acute myeloid leukemia in adults: recommendations from an international expert panel, on behalf of the European LeukemiaNet. Blood 2010;115:453-474|3 years|||participants|||Number
698978|NCT01349959|Other Pre-specified|Gene Methylation Evaluated Using Quantitative Multiple Methylation-specific Polymerase Chain Reaction (QM-MSP)|Wilcoxon rank sum tests will be used to determine the association between azacitidine or entinostat exposure and methylation changes expressed as a categorical variable (i.e.: response or no response). Data will also be graphically displayed showing trend in median values across time. Nonparametric Wilcoxon signed rank tests will be used to determine whether or not the data shows evidence of changes from baseline.|Up to 8 weeks||||||
698982|NCT01349959|Other Pre-specified|Change in Expression of Relevant Genes (e.g., ER Alpha and RAR Beta) Evaluated by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)|To evaluate baseline and change in candidate gene re-expression such as ER re-expression in malignant tissue, the absolute difference between prior to and following combination therapy (i.e., at 8 weeks) will be estimated and the median difference will be reported. These data will also be graphically displayed showing trend in median values across time. Nonparametric Wilcoxon signed rank tests will be used to determine whether or not the data shows evidence of changes from baseline.|Baseline to up to 8 weeks||||||
698983|NCT01349959|Secondary|Progression-free Survival|Estimated using the method of Kaplan-Meier.|At 6 months|||months||95% Confidence Interval|Median
698984|NCT01349959|Secondary|Overall Survival|Estimated using the method of Kaplan-Meier.|Up to 3 years|||months||95% Confidence Interval|Median
698985|NCT01349959|Secondary|Clinical Benefit Rate Estimated by the Number of Patients Who Achieve a Confirmed Response Plus the Number of Patients Who Have Stable Disease for a Duration of at Least 6 Months Divided by the Total Number of Evaluable Patients|All evaluable patients will be used for this analysis. Exact binomial 95% confidence intervals for the true clinical benefit rate will be calculated.|Up to 3 years||||||
698986|NCT01349959|Primary|Confirmed Response Rate (Complete or Partial Response Noted as the Objective Status on Two Consecutive Evaluations at Least 4 Weeks Apart) Assessed by RECIST|The proportion of successes will be estimated independently for each cohort by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.|Up to 3 years|||Percentage of participants||95% Confidence Interval|Number
698987|NCT01349933|Secondary|Duration of Response||The date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented, assessed up to 3 years||||||
698988|NCT01349933|Secondary|Best Response (Complete Response vs Partial Response vs Stable Disease vs Progression)||Up to 3 years||||||
698989|NCT01349933|Secondary|Progression-free Survival|Estimated using the method of Kaplan-Meier.|From registration to the first of either death due to any cause or progression, assessed up to 3 years||||||
698990|NCT01349933|Secondary|Overall Survival|Estimated using the method of Kaplan-Meier.|From registration to death due to any cause, assessed up to 3 years||||||
698991|NCT01349933|Secondary|Adverse Events Associated With the Agent Graded Based on CTCAE Version 4.0|The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns. Only the severe or worse adverse events will be assessed, regardless of relationship to the study treatment.|Up to 30 days after completion of study treatment||||||
698992|NCT01349933|Primary|Confirmed Response Rate Defined to be a CR or PR Noted as the Objective Status on 2 Consecutive Evaluations at Least 4 Weeks Apart|Evaluated using RECIST version 1.1. A Complete Response (CR) requires disappearance of all target lesions and each target lymph node must have reduction in short axis to <1.0 cm. A Partial Response (PR) requires at least a 30% decrease in the sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes at current evaluation. The confirmed response rate is reported as the number of participants with confirmed responses divided by the number of evaluated participants.|6 months|||percentage of participants|||Number
698993|NCT01349933|Primary|Proportion of Patients Alive and Progression-free|The primary endpoint of this trial is the proportion of patients alive and progression-free at 6 months. Progression status is evaluated using RECIST version 1.1. A Progression is defined as either: At least one new malignant lesion, which also includes any lymph node that was normal at baseline (less than 1.0 cm short axis) and increased to greater than or equal to 1 cm short axis during follow up. Or, at least a 20% increase in sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes.|6 months|||participants|||Number
698994|NCT01349920|Secondary|Concordance Correlation Coefficient for Comparison Between Central Endoscopic Evaluation and Site Endoscopic Evaluation|The CCC of blinded (central) versus unblinded (site) scores from either CDEIS or the Simple Endoscopic Score for Crohn's Disease (SES-CD) was determined at Baseline, Week 6 and Week 22. SES-CD sums the following scores: presence and size of ulcers in five visualized bowel segments; extent of ulcerated surface in five visualized bowel segments; extent of affected surface in five visualized bowel segments; presence and type of narrowings in five visualized bowel segments; and can range from 0-56, with a higher sum indicating greater severity of mucosal inflammation. The CCC can range from 0 to 1 with higher values indicating greater concordance between the 2 measurements.|Baseline, Week 6, Week 22|Participants who had both blinded and unblinded scores available for analysis.||Correlation coefficient||90% Confidence Interval|Number
698995|NCT01349920|Secondary|Concordance Correlation Coefficient for Comparison of Repeat Baseline Measurements of Biochemical Biomarkers|Based on two measurements at baseline, the concordance correlation coefficient (CCC) was computed for each of four biomarkers, using a mixed effects model with a fixed factor for repeat measurements and a random factor for participant. The CCC can range from 0 to 1 with higher values indicating greater concordance between the 2 measurements.|Baseline Visit 1 (one week prior to dosing), Baseline Visit 2 (1-2 days prior to dosing)|Participants who had both baseline serum or stool measurements available for analysis.||Correlation coefficient||90% Confidence Interval|Number
698996|NCT01349920|Primary|Coefficient of Determination (R^2) For Predicting The Change From Baseline In Blinded CDEIS Score From The Changes From Baseline In Four Biomarkers At Weeks 6 and 22|To determine R^2 a multiple linear regression analysis was conducted with the change from baseline in CDEIS score as the response variable and the baseline CDEIS score, changes from baseline in the four biomarkers serum hsCRP, serum lipocalin-2, serum Reg3-A, and stool calprotectin (their concentrations were log-transformed to make the mean function of the response more linear) at Weeks 6 and 22 as the predictor variables. CDEIS scores were provided by a blinded observer who viewed procedural videotape while blinded to the allocation number and visit of the endoscopy. The R^2 can range from 0 to 1; with higher values indicating greater predictability of the model. The primary hypothesis is that the true R^2 at weeks 6 and 22 is approximately 0.7.|Baseline and Week 6 or 22|Participants who had a blinded CDEIS score and measurements for each of the biomarkers included in the models at both baseline and at Week 6 or 22.||Coefficient of Determination|||Number
701580|NCT00054717|Secondary|Virologic Response (VL < 400 Copies/ml) at Week 64|Percentage of participants with Viral Load < 400 copies/mL|Week 64|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
698999|NCT01349920|Primary|Change From Baseline in Serum Lipocalin-2 at Week 22|Concentrations of the serum biomarker lipocalin-2 were determined at baseline and at Week 22. The change from baseline was Week 22 minus baseline.|Baseline and Week 22|Participants with measurements for lipocalin-2 at both baseline and at Week 22.||ng/mL||Standard Deviation|Mean
699000|NCT01349920|Primary|Change From Baseline in Serum Lipocalin-2 at Week 6|Concentrations of the serum biomarker lipocalin-2 were determined at baseline and at Week 6. The change from baseline was Week 6 minus baseline.|Baseline and Week 6|Participants with measurements for lipocalin-2 at both baseline and at Week 6.||ng/mL||Standard Deviation|Mean
699001|NCT01349920|Primary|Change From Baseline in Stool Calprotectin at Week 22|Concentrations of the stool biomarker calprotectin were determined at baseline and at Week 22. The change from baseline was Week 22 minus baseline.|Baseline and Week 22|Participants with measurements for calprotectin at both baseline and at Week 22.||µg/g||Standard Deviation|Mean
699002|NCT01349920|Primary|Change From Baseline in Stool Calprotectin at Week 6|Concentrations of the stool biomarker calprotectin were determined at baseline and at Week 6. The change from baseline was Week 6 minus baseline.|Baseline and Week 6|Participants with measurements for calprotectin at both baseline and at Week 6.||µg/g||Standard Deviation|Mean
699003|NCT01349920|Primary|Change From Baseline in Serum hsCRP at Week 22|Concentrations of the serum biomarker hsCRP were determined at baseline and at Week 22. The change from baseline was Week 22 minus baseline.|Baseline and Week 22|Participants with measurements for hsCRP at both baseline and at Week 22.||mg/L||Standard Deviation|Mean
699004|NCT01349920|Primary|Change From Baseline in Serum High Sensitivity C-reactive Protein (hsCRP) at Week 6|Concentrations of the serum biomarker hsCRP were determined at baseline and at Week 6. The change from baseline was Week 6 minus baseline.|Baseline and Week 6|Participants with measurements for hsCRP at both baseline and at Week 6.||mg/L||Standard Deviation|Mean
699005|NCT01349920|Primary|Change From Baseline in CDEIS Blinded Score at Week 22|CDEIS endoscopically assesses mucosal status, by summing the following six component scores: number of bowel segments with deep ulcerations divided by number of visualized bowel segments; number of bowel segments with superficial ulcerations divided by number of visualized bowel segments; mean proportion of bowel segment surface involved by disease measured on 0-10 cm visual analog scale (VAS); mean proportion of bowel segment surface area involved by ulcerations measured on 0-10 cm VAS; presence of ulcerated stenosis anywhere; and presence of non-ulcerated stenosis anywhere. An observer who viewed procedural videotape while blinded to the allocation number and visit of the endoscopy scored the CDEIS. The sum of the six components can range from 0-44, with a higher sum indicating greater severity of mucosal inflammation. Change from baseline is defined as Week 22 minus baseline CDEIS scores, with a negative change from baseline indicating improvement.|Baseline and Week 22|Participants who had a blinded CDEIS score at both baseline and at Week 22.||Score on a scale||Standard Deviation|Mean
699006|NCT01349920|Primary|Change From Baseline in the Crohn's Disease Endoscopic Index of Severity (CDEIS) Blinded Score at Week 6|CDEIS endoscopically assesses mucosal status, by summing the following six component scores: number of bowel segments with deep ulcerations divided by number of visualized bowel segments; number of bowel segments with superficial ulcerations divided by number of visualized bowel segments; mean proportion of bowel segment surface involved by disease measured on 0-10 cm visual analog scale (VAS); mean proportion of bowel segment surface area involved by ulcerations measured on 0-10 cm VAS; presence of ulcerated stenosis anywhere; and presence of non-ulcerated stenosis anywhere. An observer who viewed procedural videotape while blinded to the allocation number and visit of the endoscopy scored the CDEIS. The sum of the six components can range from 0-44, with a higher sum indicating greater severity of mucosal inflammation. Change from baseline is defined as Week 6 minus baseline CDEIS scores, with a negative change from baseline indicating improvement.|Baseline and Week 6|Participants who had a blinded CDEIS score at both baseline and at Week 6.||Score on a scale||Standard Deviation|Mean
699007|NCT01349907|Secondary|Change From Baseline in PQ-LES-Q Overall Score|PQ-LES-Q is a questionnaire to assess quality of life enjoyment and satisfaction in children and adolescents. The participant rates 15 items reflecting quality of life from the previous week. Item 15, the PQ-LES-Q overall score, observed OC, is a global assessment of overall quality of life, and ranges from 1 to 5, with a higher score indicating better quality of life. An improvement in quality of life is represented by change from baseline values that are positive.|Baseline, Day 182 and Day 350|Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment.||Score on a scale||Standard Deviation|Mean
699008|NCT01349907|Secondary|Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaires (PQ-LES-Q) Total Score|PQ-LES-Q is a questionnaire to assess quality of life enjoyment and satisfaction in children and adolescents. The participant rates 15 items reflecting quality of life from the previous week on a scale of 1=very poor to 5=very good. Items 1-14 assess specific areas (e.g., health, mood or feelings); item 15 is a global assessment of overall quality of life. The PQ-LES-Q total score for each participant, OC is the sum of the rating assigned to each of the first 14 items, and ranges from 14 to 70, with a higher score indicating better quality of life. An improvement in quality of life is represented by change from baseline values that are positive.|Baseline, Day 182 and Day 350|Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment.||Score on a scale||Standard Deviation|Mean
699009|NCT01349907|Secondary|Percentage of Participants With a CGAS Score of Equal or Greater Than 70|CGAS is a scale with a possible range of 1 to 100, measuring psychological, social, and school functioning in children. Minimum scores, OC range from 1-10, representing the need for constant supervision (worse result) to maximum scores of 91-100, representing superior functioning (better result). The percentage of participants with a score of 70 or greater, representing normal to superior social functioning, is shown.|Up to Day 350|Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment.||Percentage of participants|||Number
699056|NCT01349790|Secondary|Percentage of Responders Who Achieved a Normal Platelet Count|The percentage of responders who achieved a normal platelet count is presented.|Day 1 to Day 22|Full analysis set: All participants enrolled in the study who received at least part of 1 dose of NewGam who had at least 1 post-baseline measurement of platelet concentration. Only responders were included in the analysis.||Percentage of participants||95% Confidence Interval|Number
699010|NCT01349907|Secondary|Change From Baseline in Children's Global Assessment Scale (CGAS)|CGAS is a scale with a possible range of 1 to 100, measuring psychological, social, and school functioning in children. Minimum scores, OC range from 1-10, representing the need for constant supervision (worse result) to maximum scores of 91-100, representing superior functioning (better result). An improvement in function is represented by a change from baseline value that is positive.|Baseline, Day 182 and Day 350|Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment.||Score on a scale||Standard Deviation|Mean
699011|NCT01349907|Secondary|Percentage of Participants With Emergent Depression Based on CDRS-R|The CDRS-R is a 17-item clinician-rated instrument for assessing the presence and severity of depressive symptoms in children. The CDRS-R total score, OC for each participant is the sum of the ratings for the 17 individual items, and can range from 17-113, with higher scores indicating greater severity of symptoms. Participants with a CDRS-R score of 40 or greater (whose baseline CDRS-R is less than 40) exhibit emergent depression, which is a strong indicator of the presence or potential for a major depressive disorder.|Up to Day 350|Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment.||Percentage of participants|||Number
699012|NCT01349907|Secondary|Percentage of CDRS-R Responders|The CDRS-R is a 17-item clinician-rated instrument for assessing the presence and severity of depressive symptoms in children. The CDRS-R total score, OC for each participant is the sum of the ratings for the 17 individual items, and can range from 17-113, with higher scores indicating greater severity of symptoms. A CDRS-R responder experiences a 50% or more decrease from baseline in CDRS-R total score.|Up to Day 350|Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment.||Percentage of participants|||Number
699013|NCT01349907|Secondary|Change From Baseline in Children's Depression Rating Scale, Revised (CDRS-R) Total Score|The CDRS-R is a 17-item clinician-rated instrument for assessing the presence and severity of depressive symptoms in children. Fourteen of the 17 items are rated on a scale of 1-7, and 3 of the items are rated on a scale of 1-5, with higher scores indicating greater severity of symptoms. The CDRS-R total score, OC for each participant is the sum of the ratings for the 17 individual items, and can range from 17-113, with higher scores indicating greater severity of symptoms. Improvement in symptoms is represented by change from baseline values that are negative.|Baseline, Day 182 and Day 350|Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment.||Score on a scale||Standard Deviation|Mean
699014|NCT01349907|Secondary|Change From Baseline in Clinical Global Impression Scale for Assessing Mania (CGI-BP Mania)|The CGI-BP mania is a single value score OC for assessing mania, recorded on a 7-point scale ranging from 1 for normal/not ill, to 7 for very severely ill. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline, Day 182 and Day 350|Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment.||Score on a scale||Standard Deviation|Mean
699015|NCT01349907|Secondary|Change From Baseline in Clinical Global Impression Scale for Assessing Depression (CGI-BP Depression)|The CGI-BP depression is a single value score OC for assessing depression, recorded on a 7-point scale ranging from 1 for normal/not ill, to 7 for very severely ill. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline, Day 182 and Day 350|Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment.||Score on a scale||Standard Deviation|Mean
699016|NCT01349907|Secondary|Change From Baseline in Clinical Global Impression Scale for Assessing Overall Bipolar Illness (CGI-BP Overall)|The CGI-BP overall is a single value score OC for assessing overall bipolar illness, recorded on a 7-point scale ranging from 1 for normal/not ill, to 7 for very severely ill. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline, Day 182 and Day 350|Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment.||Score on a scale||Standard Deviation|Mean
699017|NCT01349907|Secondary|Time to Failure to Maintain Response in Y-MRS Total Score|The Y-MRS is an 11-item clinician-rated instrument for assessing the severity of manic episodes. The Y-MRS total score, OC for each participant is the sum of the ratings for the 11 individual items, ranging from 0-60, with higher scores indicating more severe symptoms. The time to failure is the number of days from first achieving a 50% or more decrease from baseline in Y-MRS total score to the first subsequent day of a less than 50% decrease from baseline in Y-MRS total score.|Up to Day 350|Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment. Restricted to participants who were total Y-MRS 50% responders in base trial P06107.||Days||95% Confidence Interval|Median
699018|NCT01349907|Secondary|Time to First Total Y-MRS 50% Response|The Y-MRS is an 11-item clinician-rated instrument for assessing the severity of manic episodes. The Y-MRS total score, OC for each participant is the sum of the ratings for the 11 individual items, ranging from 0-60, with higher scores indicating more severe symptoms. The time to 50% response is the number of days on treatment to achieve a 50% decrease from baseline in Y-MRS total score.|Up to Day 350|Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment.||Days||95% Confidence Interval|Median
699019|NCT01349907|Secondary|Percentage of Participants Who Were Y-MRS Total Score Responders|The Y-MRS is an 11-item clinician-rated instrument for assessing the severity of manic episodes. The Y-MRS total score, OC for each participant is the sum of the ratings for the 11 individual items, and can range from 0-60, with higher scores indicating greater severity of symptoms. A Y-MRS responder experiences a 50% or more decrease from baseline in Y-MRS total score.|Up to Day 350|Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment.||Percentage of participants|||Number
699057|NCT01349790|Secondary|Maximum Platelet Count|The maximum platelet count achieved during the study is presented.|Day 1 to Day 22|Full analysis set: All participants enrolled in the study who received at least part of 1 dose of NewGam who had at least 1 post-baseline measurement of platelet concentration.||10^9 platelets/L||Standard Deviation|Mean
699020|NCT01349907|Secondary|Percentage of Participants Who Were Y-MRS Total Score Remitters (Y-MRS ≤12)|The Y-MRS is an 11-item clinician-rated instrument for assessing the severity of manic episodes. The Y-MRS total score, OC for each participant is the sum of the ratings for the 11 individual items, and can range from 0-60, with higher scores indicating greater severity of symptoms. A remitter is a participant with a Y-MRS total score of 12 or lower.|Up to Day 350|Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment.||Percentage of participants|||Number
699021|NCT01349907|Secondary|Change From Baseline in Young Mania Rating Scale (Y-MRS) Total Score|The Y-MRS assesses the severity of manic episodes by assigning a severity rating to each of 11 items (Elevated mood, Increased motor activity-energy, Sexual interest, Sleep, Irritability, Speech, Language-thought disorder, Thought content, Disruptive-aggressive behavior, Appearance, Insight). Seven of the 11 items are rated on a scale of 0-4, and 4 of the items are rated on a scale of 0-8. The Y-MRS total score, observed cases (OC), the assessment closest to the scheduled assessment day within the allowed window, is the sum of the ratings for the 11 individual items, and can range from 0-60, with higher scores indicating greater severity of symptoms. Improvement in symptoms is represented by change from baseline values that are negative.|Baseline, Day 182 and Day 350|Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment.||Score on a scale||Standard Deviation|Mean
699022|NCT01349907|Primary|Number of Participants Who Experienced Clinical or Laboratory Adverse Events|A clinical or laboratory adverse event is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.|Baseline (Day 1) to 30 days after the last dose of study drug (up to approximately 54 weeks)|Participants who received at least one dose of trial medication, and were 17 years old or younger. One treated participant from the Placebo/Asenapine group, who was 18 years old, was excluded from this analysis.||Participants|||Number
699023|NCT01349829|Secondary|Geometric Mean Concentrations (GMCs)|GMCs of anti-HAV antibodies will be measured from blood samples|Month 7|Results are for the ATP population included all randomized subjects who received the first and second vaccination and had negative anti-HAV antibody concentrations at baseline, no major protocol violations and whose serum sample after the second vaccination was available for measurement of immunogenicity||mIU/mL||95% Confidence Interval|Mean
699024|NCT01349829|Secondary|Geometric Mean Concentrations (GMCs)|GMCs of anti-HAV antibodies will be measured from blood samples|Month 6|Results are for the ATP population included all randomized subjects who received the first vaccination and had negative anti-HAV antibody concentrations at screening, no major protocol violations and whose serum sample was available for measurement of immunogenicity||mIU/mL||95% Confidence Interval|Mean
699025|NCT01349829|Secondary|Geometric Mean Concentrations (GMCs)|GMCs of anti-HAV antibodies will be measured from blood samples|Month 1|Results are for the ATP population included all randomized subjects who received the first vaccination and had negative anti-HAV antibody concentration at screening, and who had no major protocol violations and whose serum sample after the first vaccination was available for measurement of immunogenicity||mIU/mL||95% Confidence Interval|Mean
699026|NCT01349829|Secondary|Seroprotection at Month 7|Proportion of subjects seroprotected (>=10 mIU/ml)|Month 7|Results are for the ATP population included all randomized subjects who received the first and second vaccination and had negative anti-HAV antibody concentrations at baseline, no major protocol violations and whose serum sample after the second vaccination was available for measurement of immunogenicity||percentage of participants||95% Confidence Interval|Number
699027|NCT01349829|Secondary|Seroprotection at Month 6|Proportion of subjects seroprotected (>=10 mIU/ml)|Month 6|Results are for the ATP population included all randomized subjects who received the first vaccination and had negative anti-HAV antibody concentrations at screening, no major protocol violations and whose serum sample was available for measurement of immunogenicity||percentage of participants||95% Confidence Interval|Number
699028|NCT01349829|Primary|Seroprotection at Month 1|Proportion of subjects seroprotected (seroprotection defined as anti-HAV antibody concentration >=10 mIU/ml)|Month 1|Results are for the ATP population included all randomized subjects who received the first vaccination and had negative anti-HAV antibody concentration at screening, and who had no major protocol violations and whose serum sample after the first vaccination was available for measurement of immunogenicity||percentage of participants||95% Confidence Interval|Number
699029|NCT01349816|Secondary|Mean Evening Trough FEV1|Change from baseline in mean evening 12-hour post-dose trough FEV1|Day 7|MITT Population||Liters||95% Confidence Interval|Least Squares Mean
699030|NCT01349816|Secondary|Peak Change From Baseline in IC|Peak change from baseline in inspiratory capacity (IC) (mean of 1 and 2 hours post-dose minus baseline)|Day 7|MITT Population||Liters||95% Confidence Interval|Least Squares Mean
699031|NCT01349816|Secondary|FEV1 Through 6 Hours|Peak change from baseline in FEV1 through 6 hours|Day 7|MITT Population||Liters||95% Confidence Interval|Least Squares Mean
699032|NCT01349816|Secondary|Morning Pre-dose FEV1|Change from baseline in morning pre-dose FEV1 (average of 60- and 30-minute pre-dose values on Day 7)|Day 7|MITT Population||Liters||95% Confidence Interval|Least Squares Mean
699033|NCT01349816|Secondary|Peak Change in IC|Mean inspiratory capacity (IC) of 1 and 2 hours post-dose minus baseline|Day 1|MITT Population||Liters||95% Confidence Interval|Least Squares Mean
699034|NCT01349816|Secondary|At Least 12% Improvement in FEV1|Proportion of subjects achieving >=12% improvement in FEV1 relative to baseline|Day 1|MITT Population||Participants|||Number
699035|NCT01349816|Secondary|Time to Onset of Action|At least 10% improvement in mean FEV1|Day 1|MITT Population||Participants|||Number
699036|NCT01349816|Secondary|Peak Change From Baseline in FEV1|Peak change from baseline in FEV1 through 2 hours|Day 1|MITT Population||Liters||95% Confidence Interval|Least Squares Mean
699037|NCT01349816|Primary|FEV1 AUC0-12|Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-12 relative to baseline following chronic dosing (1 week).|Day 7|Modified Intent to Treat (MITT) Population is made of participants who completed both treatment periods and had Pre-dose Day 1 data for both and no protocol deviations believed to have a potential impact on efficacy results. Subjects must have had data for the given endpoint to be included.||Liters||95% Confidence Interval|Least Squares Mean
724711|NCT00346632|Secondary|Area Under the Plasma Concentration-time Curve From 0 to Tau (AUC (0-tau, Tau is the Dosing Interval))||Days 1 and 14 (and Day 28 for Arm B) of Cycle 1|||hr*ng/mL||Standard Deviation|Mean
699038|NCT01349803|Secondary|Mean Change From Baseline in QTcF Interval|The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).|Baseline, Day 1, Day 7, and Day 14|Safety Population||msec||Standard Deviation|Mean
699039|NCT01349803|Secondary|Change From Baseline in the Number of Tachycardia Episodes Recorded During 24-Hour Holter Monitoring|The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).|Baseline, Day 1, and Day 14|Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding.||Tachycardia episodes / hour||Standard Error|Mean
699040|NCT01349803|Secondary|Change From Baseline in the Number of Bradycardia Episodes Recorded During 24-Hour Holter Monitoring|The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).|Baseline, Day 1, and Day 14|Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding.||Bradycardia episodes / hour||Standard Error|Mean
699041|NCT01349803|Secondary|Change From Baseline in the Number of Supraventricular Runs Recorded During 24-Hour Holter Monitoring|The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).|Baseline, Day 1, and Day 14|Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding.||Supraventricular runs / hour||Standard Error|Mean
699042|NCT01349803|Secondary|Change From Baseline in the Number of Supraventricular Couplets Recorded During 24-Hour Holter Monitoring|The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).|Baseline, Day 1, and Day 14|Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding.||Supraventricular couplets / hour||Standard Error|Mean
699043|NCT01349803|Secondary|Change From Baseline in the Number of Isolated Supraventricular Events Recorded During 24-Hour Holter Monitoring|The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).|Baseline, Day 1, and Day 14|Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding.||Supraventricular events / hour||Standard Error|Mean
699044|NCT01349803|Secondary|Change From Baseline in the Number of Ventricular Runs Recorded During 24-Hour Holter Monitoring|The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).|Baseline, Day 1, and Day 14|Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding.||Ventricular runs / hour||Standard Error|Mean
699045|NCT01349803|Secondary|Change From Baseline in the Number of Ventricular Couplets Recorded During 24-Hour Holter Monitoring|The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).|Baseline, Day 1, and Day 14|Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding.||Ventricular couplets / hour||Standard Error|Mean
699058|NCT01349790|Secondary|Platelet Count by Visit|The platelet count at each study visit are presented.|Day 1 to Day 22|Full analysis set: All participants enrolled in the study who received at least part of 1 dose of NewGam who had at least 1 post-baseline measurement of platelet concentration.||10^9 platelets/L||Standard Deviation|Mean
699133|NCT01348139|Primary|E22-26h: The Average of the FEV1 Values Between 22 and 26 h for Every Treatment Visit|Trough effect (E22-26h) will be computed from the repeated measurements collected after each single dose during 22-26 hours of FEV1 from visit 2 to 7.|22-26 hrs.|PD analysis set||Liters||Standard Deviation|Mean
699046|NCT01349803|Secondary|Change From Baseline in Number of Isolated Ventricular Events Recorded During 24-Hour Holter Monitoring|The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).|Baseline, Day 1, and Day 14|Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding.||Ventricular events / hour||Standard Error|Mean
699047|NCT01349803|Secondary|Change From Baseline in 24-Hour Minimum Heart Rate|The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).|Baseline, Day 1, and Day 14|Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding.||bpm||95% Confidence Interval|Least Squares Mean
699048|NCT01349803|Secondary|Change From Baseline in 24-Hour Maximum Heart Rate|The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).|Baseline, Day 1, and Day 14|Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding.||bpm||95% Confidence Interval|Least Squares Mean
699049|NCT01349803|Secondary|Change From Baseline in Night Time Mean Heart Rate|The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).|Baseline, Day 1, and Day 14|Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding.||bpm||95% Confidence Interval|Least Squares Mean
699050|NCT01349803|Secondary|Change From Baseline in Daytime Mean Heart Rate|The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).|Baseline, Day 1, and Day 14|Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding.||bpm||95% Confidence Interval|Least Squares Mean
699051|NCT01349803|Secondary|Change From Baseline in 24-Hour Mean Heart Rate for Day 1 of Treatment|The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).|24 hours|Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding.||bpm||95% Confidence Interval|Least Squares Mean
699052|NCT01349803|Secondary|Change From Baseline in Mean FEV1 Trough|Trough FEV1 averaged over Day 7 and Day 14|Day 7 to Day 14|MITT - patients from the ITT population who completed at least one evaluable FEV1 spirometry assessment for baseline (pre-dose on Day 1) and had an evaluable FEV1 spirometry assessment on at least one of the following: Day 7 pre-dose or Day 14 pre-dose (or both).||Liters||95% Confidence Interval|Least Squares Mean
699053|NCT01349803|Primary|Change From Baseline in 24-Hour Mean Heart Rate Post-dose|The primary safety objective of this study was to compare the change in mean heart rate averaged over 24 hours post-dose, following twice daily dosing over 14 days with PT003 MDI, PT005 MDI, PT001 MDI or Foradil Aerolizer compared to baseline in patients with moderate to severe chronic obstructive pulmonary disease (COPD).|14 days|Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding.||bpm||95% Confidence Interval|Least Squares Mean
699054|NCT01349790|Secondary|Percentage of Participants Who Achieved a Platelet Count > 30x10^9/L|The percentage of participants who achieved a platelet count > 30x10^9/L within 1 and 2 days after infusion is reported.|Day 1 to Day 2|Safety set: All participants enrolled in the study who received at least part of 1 dose of NewGam.||Percentage of participants|||Number
699055|NCT01349790|Secondary|Bleeding Intensity|The percentage of participants with various intensities of overall bleeding, epistaxis (bleeding of the nose), oral bleeding, and skin bleeding graded as none, minor, mild, moderate, or severe at Baseline and Day 22 are reported.|Day 1 to Day 22|Full analysis set: All participants enrolled in the study who received at least part of 1 dose of NewGam who had at least 1 post-baseline measurement of platelet concentration.||Percentage of participants|||Number
699089|NCT01348854|Primary|Reduction of Astigmatism|Reduction of astigmatism as determined by manifest refractive cylinder|6 months|Data analysis was performed for eyes treated. Subjects may have had one or both eyes treated. If both eyes, one eye may have been in Natural Astigmatism group and the other eye in the Post Cataract with Residual Astigmatism group.||diopter|Participants|Standard Deviation|Mean
699059|NCT01349790|Secondary|Duration of a Complete Response|The duration of a complete response was defined as the time from when a complete response was achieved until the platelet count fell below 50x10^9/L.|Day 1 to Day 22|Full analysis set: All participants enrolled in the study who received at least part of 1 dose of NewGam who had at least 1 post-baseline measurement of platelet concentration. Only participants with a complete response were included in the analysis.||Days||95% Confidence Interval|Median
699060|NCT01349790|Secondary|Duration of an Alternative Response|The duration of an alternative response was defined as the time from when an alternative response was achieved until the platelet count fell below 50x10^9/L.|Day 1 to Day 22|Full analysis set: All participants enrolled in the study who received at least part of 1 dose of NewGam who had at least 1 post-baseline measurement of platelet concentration. Only participants with an alternative response were included in the analysis.||Days||95% Confidence Interval|Median
699061|NCT01349790|Secondary|Duration of a Response|The duration of a response was defined as the time from when a response was achieved until the platelet count fell below 50x10^9/L.|Day 1 to Day 22|Full analysis set: All participants enrolled in the study who received at least part of 1 dose of NewGam who had at least 1 post-baseline measurement of platelet concentration. Only responders were included in the analysis.||Days||95% Confidence Interval|Median
699062|NCT01349790|Secondary|Time to a Complete Response|A study participant had a complete response if their platelets increased to ≥ 100x10^9/L, confirmed on at least 2 occasions at least 7 days apart, and absence of bleeding.|Day 1 to Day 22|Full analysis set: All participants enrolled in the study who received at least part of 1 dose of NewGam who had at least 1 post-baseline measurement of platelet concentration. Only participants with a complete response were included in the analysis.||Days||95% Confidence Interval|Median
699063|NCT01349790|Secondary|Time to an Alternative Response|A study participant had a response if their platelets increased to ≥ 30x10^9/L and to at least double the baseline platelet count, confirmed on at least 2 occasions at least 7 days apart, and absence of bleeding.|Day 1 to Day 22|Full analysis set: All participants enrolled in the study who received at least part of 1 dose of NewGam who had at least 1 post-baseline measurement of platelet concentration. Only participants with an alternative response were included in the analysis.||Days||95% Confidence Interval|Median
699064|NCT01349790|Secondary|Time to a Response|A study participant had a response if their platelets increased to ≥ 50x10^9/L within 7 days after the first infusion, ie, by study Day 8.|Day 1 to Day 8|Full analysis set: All participants enrolled in the study who received at least part of 1 dose of NewGam who had at least 1 post-baseline measurement of platelet concentration. Only responders were included in the analysis.||Days||95% Confidence Interval|Median
699065|NCT01349790|Secondary|Percentage of Complete Responders Who Lost the Response|A complete responder who lost the response is a study participant who met the criterion for a complete response but who then deteriorated, ie, their platelet count decreased to < 100x10^9/L or bleeding occurred.|Day 1 to Day 22|Full analysis set: All participants enrolled in the study who received at least part of 1 dose of NewGam and who had at least 1 post-baseline measurement of platelet concentration. Only participants with a complete response were included in the analysis.||Percentage of participants||95% Confidence Interval|Number
699066|NCT01349790|Secondary|Percentage of Alternative Responders Who Lost the Response|An alternative responder who lost the response is a study participant who met the criterion for an alternative response but who then deteriorated, ie, their platelet count decreased to < 30x10^9/L, their platelet count decreased to less than double the baseline count, or bleeding occurred.|Day 1 to Day 22|Full analysis set: All participants enrolled in the study who received at least part of 1 dose of NewGam and who had at least 1 post-baseline measurement of platelet concentration. Only participants with an alternative response were included in the analysis.||Percentage of participants||95% Confidence Interval|Number
699067|NCT01349790|Secondary|Percentage of Complete Responders|A complete responder is a study participant with an increase in platelets to ≥ 100x10^9/L, confirmed on at least 2 occasions at least 7 days apart, and absence of bleeding.|Day 1 to Day 22|Full analysis set: All participants enrolled in the study who received at least part of 1 dose of NewGam and who had at least 1 post-baseline measurement of platelet concentration.||Percentage of participants||95% Confidence Interval|Number
699068|NCT01349790|Secondary|Percentage of Alternative Responders|An alternative responder is a study participant with an increase in platelets to ≥ 30x10^9/L and to at least double the baseline platelet count, confirmed on at least 2 occasions at least 7 days apart, and absence of bleeding.|Day 1 to Day 22|Full analysis set: All participants enrolled in the study who received at least part of 1 dose of NewGam and who had at least 1 post-baseline measurement of platelet concentration.||Percentage of participants||95% Confidence Interval|Number
699069|NCT01349790|Primary|Percentage of Responders|A responder is a study participant with an increase in platelets to ≥ 50x10^9/L within 7 days after the first infusion, ie, by study Day 8.|Day 1 to Day 8|Full analysis set: All participants enrolled in the study who received at least part of 1 dose of NewGam and who had at least 1 post-baseline measurement of platelet concentration.||Percentage of participants||95% Confidence Interval|Number
699070|NCT01349595|Primary|The Incidence of a Combined Endpoint of Death-censored Graft Loss or Greater Than 50% Reduction in Estimated Glomerular Filtration (eGFR) in Study Subjects.||60 months after enrollment in the study|Results data for zero participants were analyzed; long-term follow-up evaluation of participants was not possible due to discontinuation of funding.|||||
699071|NCT01349491|Primary|Primary Outcome - Number of Participants With Atrial Fibrillation|To determine if ranolazine is effective in decreasing recurrences of AF in patients with persistent AF successfully treated with electrical cardioversion.|6 months|||participants|||Number
699072|NCT01349465|Primary|Percentage of Participants With Change in Sequence of HCV NS3/4A Region Over Time in Participants With Confirmed Detectable HCV RNA (Without Q80K at Baseline) at the Last Visit of the Previous Study|Sequencing was performed to assess changes in the sequence of the HCV NS3/4A protein region over time in participants with no SVR at LPVPS (ie confirmed detectable HCV RNA at the last visit of the previous study). EOS defined as last available sequencing sample. AEM and NEM represents any emerging mutation and no emerging mutation at time of failure of the previous study.|Baseline and Month 36|"N signifies number of particpants with no SVR at LPVPS and with available sequence data. n defines the number of participants analyzed at specified time point."||Percentage of participnats|||Number
724712|NCT00346632|Secondary|Time to Peak Plasma Concentration (Tmax)||Days 1 and 14 (and Day 28 for Arm B) of Cycle 1|||hours||Standard Deviation|Mean
699073|NCT01349465|Primary|Percentage of Participants With Change in Sequence of HCV NS3/4A Region Over Time in Participants With Confirmed Detectable HCV RNA (With Q80K at Baseline) at the Last Visit of the Previous Study|Sequencing was performed to assess changes in the sequence of the HCV NS3/4A protein region over time in participants with no SVR at LPVPS (ie confirmed detectable HCV RNA at the last visit of the previous study). EOS defined as last available sequencing sample. AEM and NEM represents any emerging mutation and no emerging mutation at time of failure of the previous study.|Baseline and Month 36|"N signifies number of particpants with no SVR at LPVPS and with available sequence data. n defines the number of participants analyzed at specified time point."||Percentage of participants|||Number
699074|NCT01349465|Secondary|Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability||End of study (at month 36)|||Participants|||Number
699075|NCT01349465|Secondary|Percentage of Participants With Late Viral Relapse|Relapse at any time after the LPVPS until the last individual visit of this study. All participants maintained SVR until the last available visit. No late viral relapse was therefore observed.|End of study (at month 36)|Late viral relapse was evaluated in all enrolled participants with SVR at LPVPS.||percentage of participants|||Number
699076|NCT01349465|Primary|Overall Percentage of Participants With Change in Sequence of HCV NS3/4A Region Over Time in Participants With Confirmed Detectable HCV RNA at the Last Visit of the Previous Study|Sequencing was performed to assess changes in the sequence of the HCV NS3/4A protein region over time in participants with no SVR at LPVPS (ie confirmed detectable HCV RNA at the last visit of the previous study). EOS defined as last available sequencing sample. AEM and NEM represents any emerging mutation and no emerging mutation at time of failure of the previous study.|Baseline and Month 36|"N signifies number of participants with no SVR at LPVPS and with available sequence data. n defines the number of participants analyzed at specified time point."||Percentage of participants|||Number
699077|NCT01349465|Primary|Percentage of Participants Maintaining SVR at the Last Available Visit|The SVR rate is the proportion (%) of participants with HCV RNA less than (<) 25 International Units/milliliter (IU/mL).|Last Available Visit (Month 36 for subjects completing the study)|All participants with SVR at LPVPS were included in the population analysis set.||Percentage of participants||95% Confidence Interval|Number
699078|NCT01349231|Secondary|Depression Symptoms|We will examine change from baseline in Hamilton Rating Scale for Depression (HRDS) ratings of depression severity at day 1-3 following a single ketamine infusion. The HRDS assesses severity of, and change in, depressive symptoms. The HRDS is a 21 item scale with scores ranging from 0-66. The higher the score, the more severe the depression.|Baseline, Day 1, Day 2, and Day 3|||units on a scale||Standard Deviation|Mean
699079|NCT01349231|Primary|OCD Severity|We will examine change from baseline in the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) ratings of OCD severity at 3 days following infusion. The Yale-Brown Obsessive Compulsive Scale (Y-BOCS) assesses obsessive and compulsive symptom severity. Obsessions are rated on a scale from 0-20 and compulsions are rated on a scale of 0-20, for a total scale of 0-40. Scores on the obsessions scale and scores on the compulsions scale are summed to obtain the total score. The higher the score, the more severe the OCD.|Baseline and 3 days following infusion|||units on a scale||Standard Deviation|Mean
699080|NCT01349231|Primary|OCD Severity|We will examine change from baseline in the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) ratings of OCD severity at 2 days following infusion. The Yale-Brown Obsessive Compulsive Scale (Y-BOCS) assesses obsessive and compulsive symptom severity. Obsessions are rated on a scale from 0-20 and compulsions are rated on a scale of 0-20, for a total scale of 0-40. Scores on the obsessions scale and scores on the compulsions scale are summed to obtain the total score. The higher the score, the more severe the OCD.|Baseline and 2 days following infusion|||units on a scale||Standard Deviation|Mean
699081|NCT01349231|Primary|OCD Severity|We will examine change from baseline in the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) ratings of OCD severity at 1 day following infusion. The Yale-Brown Obsessive Compulsive Scale (Y-BOCS) assesses obsessive and compulsive symptom severity. Obsessions are rated on a scale from 0-20 and compulsions are rated on a scale of 0-20, for a total scale of 0-40. Scores on the obsessions scale and scores on the compulsions scale are summed to obtain the total score. The higher the score, the more severe the OCD.|Baseline and 1 day after ketamine infusion|||units on a scale||Standard Deviation|Mean
699082|NCT01349192|Secondary|Pulmonary Exacerbations|Proportion of subjects with a protocol-defined pulmonary exacerbation (PE) between baseline and day 28 who are treated with antibiotics active against MRSA.|28 days|Intention to treat||Participants|||Count of Participants
699083|NCT01349192|Secondary|Antibiotic Use (Days of Use Per Subject)|Days of use of oral, inhaled, and IV antibiotics over the 6 month study.|6 months|Intention to treat||days||Standard Deviation|Mean
699084|NCT01349192|Secondary|Antibiotic Use (Proportion of Subjects)|Proportion of subjects treated with oral, inhaled, and IV antibiotics over the 6 month study.|6 months|Intention to treat||Participants|||Count of Participants
699085|NCT01349192|Primary|MRSA Culture Status|Proportion of subjects with a negative culture for MRSA at Day 28.|Day 28|The analysis population is defined as all of the participants who were randomized to a study arm and were assessed for the primary microbiologic efficacy endpoint at both baseline and Day 28.||Participants|||Count of Participants
699086|NCT01349114|Secondary|Mean Central Aortic Pressure at 3 Months|Baseline to 3 months after Aliskiren/PLC, reported value at 3 months after start of study of central aortic pressure assessed by non-invasive applanation tonometry ( SphygmoCor, Atcor)|3 months after start of study|Aortic pressure indicates the augmentation pressure (AP) in mmHg derived from the radial artery waveform.||mm Hg||Standard Deviation|Mean
699087|NCT01349114|Primary|Change in Flow-mediated Dilation|Flow-mediated dilation of the brachial artery assessed by ultrasound to evaluate improvement of arterial functioning by % of dilation after non-invasive occlusion|Baseline to 3 months|||percentage of flow-mediated dilation||Standard Deviation|Mean
699088|NCT01348854|Secondary|Percent of Eyes With Loss of ≥ 2 Lines of Best Spectacle Corrected Visual Acuity (BSCVA)||6 months|Data analysis was performed for eyes treated. Subjects may have had one or both eyes treated. If both eyes, one eye may have been in Natural Astigmatism group and the other eye in the Post Cataract with Residual Astigmatism group.||percentage of eyes|Participants||Number
699090|NCT01348789|Secondary|Hair Clearance|Hair Clearance = the percent of hair cleared from baseline to follow up|8 weeks after last treatment|||%baseline hair count|Participants|Standard Deviation|Median
699091|NCT01348789|Secondary|Tolerability Level of the Procedure for Each Treatment Separately for Light and Dark Skin.|Subject self-report of the tolerability of the procedure (no pain, mild pain, moderate pain) after each of the treatments (#1, #2, #3)separately for relatively light and dark skin photo-types (I-IV and V-VI respectively according to Fitzpatrick skin photo-type classification)|0, 3, 7 days (after treatment #1, #2, and #3 respectively)|||number of areas|Participants||Number
699092|NCT01348789|Primary|Percentage of Participants With Device Related Anticipated Skin Effects, Serious Adverse Events, or Adverse Events.|"The immediate skin reaction and long-term side and adverse effects were evaluated on site by a dermatologist. This includes the following clinical outcomes:
Presence of transient (disappearing < 24 hours) or prolonged erythema
Presence of transient (disappearing < 24 hours) or prolonged edema
Self-limited bleeding from mechanical shaving
Blister formation
Ulcer formation
Pigment changes (hypo/hyper)
Textural changes
Scarring
Infection
Pruritis
Post inflammation reactions
Allergic reaction
The safety of the device will be confirmed if no device related serious adverse event will occur."|Up to 3 months|Intention to treat analysis - all participants that received at least 1 treatment.||percentage of particpants||95% Confidence Interval|Number
699093|NCT01348776|Secondary|Subject Satisfaction|Gathering information about the subject satisfaction from the hair removal procedure based on 5 point satisfaction scale.|5 months (final follow up)|Two subjects did not report on satisfaction.||participants|||Number
699094|NCT01348776|Secondary|Tolerability Level of the Procedure Following Treatments|"Gathering information about the tolerability of the procedure following weekly treatments 1, 3, 7 and maintenance treatment 3 by asking subjects to rate the tolerability of the procedure based on 5 point pain scale (no pain, mild pain, moderate pain, severe pain, Intolerable [had to stop treatment]) .
The distribution of the tolerability level is based on the analysis of the areas treated and not on the number of participants since each participant was treated on more than one area. Therefore the number of treated areas exceeds the number of participants and the unit of measurement is % treated areas that were rated."|1, 3, 7 weeks (basic weekly treatment 1, 3, and 7), and 5 months (maintenance monthly treatment#3)|||% treated areas|Participants||Number
699095|NCT01348776|Secondary|Occurrence of Anticipated Effects on Skin|As with other IPL devices, subjects were informed that they should expect some sense of warmth, tingling, or itching, when the device was applied. This was anticipated to be mild to moderate. Subjects could also expect transient erythema and edema at the treatment site that usually disappears within 24 hours.|Up to 19 weeks|||Number of reports|Participants||Number
699096|NCT01348776|Secondary|Hair Clearance at 3-month (Final) Follow up|Hair clearance = %hair cleared from baseline to endpoint after 7 weekly treatments with or without additional 2 monthly maintenance treatments.|5 months (3 months after 7 weekly treatments)|All areas with photos that allowed reliable hair counting were included for this analysis.||%baseline hair count|Participants|Standard Error|Mean
699097|NCT01348776|Primary|Hair Clearance 1 Month After Last Treatment|Hair clearance = the percent of hair cleared from baseline to endpoint.|3 months (1 month after 7 weekly treatments)|Sample size was discussed with the FDA during a pre-IDE meeting.||%baseline hair count|Participants|Standard Deviation|Mean
699098|NCT01348607|Secondary|Adverse Events|Adverse events assessed at all subject visits by interviews with the subject and the subject's parent/ primary caregiver.|29 days|||events|||Number
699099|NCT01348607|Primary|Average Daytime Napping Minutes in a Week|Outcome measure was the total of daytime napping minutes in a week as assessed by participant sleep diaries|29 days|||minutes||Standard Deviation|Mean
699100|NCT01348425|Primary|Percent Change in Stent Length Upon Deployment||During Procedure (day 1) (Prior to Stent Deployment and after Stent Deployment)|||Change in stent length (%)||Standard Deviation|Mean
699101|NCT01348165|Primary|Assessment of Tolerability by Investigator|The investigator assessed tolerability based on adverse events and the laboratory evaluation according to the categories ‘good’, ‘satisfactory’, ‘not satisfactory’, and ‘bad’.|28 days|Treated Set||Participants|||Number
699102|NCT01348165|Primary|Body Temperature|Change from baseline to 28 Days in Body temperature|Baseline and 28 days|Treated Set||degrees celcius||Standard Deviation|Mean
699103|NCT01348165|Secondary|Minimum Effect (Emin)|Minimum effect for TNF-alpha induced by LPS and LTB4 induced by fMLP. Results indicate percent change from baseline of TNF-α/LTB4 production. A positive value indicates inhibition of the production.|30 minutes (min) before drug administration and 2 hours (h), 6h, 24h and 48h after drug administration|Treated Set. Summary statistics were not calculated for the 0.5 mg group as there was only one patient in this group.||pg/mL||Geometric Coefficient of Variation|Geometric Mean
699104|NCT01348165|Secondary|Maximum Effect (Emax)|Maximum effect for TNF-alpha induced by LPS and LTB4 induced by fMLP. Results indicate percent change from baseline of TNF-α/LTB4 production. A positive value indicates inhibition of the production.|30 minutes (min) before drug administration and 2 hours (h), 6h, 24h and 48h after drug administration|Treated Set. Summary statistics were not calculated for the 0.5 mg group as there was only one patient in this group.||pg/mL||Geometric Coefficient of Variation|Geometric Mean
699105|NCT01348165|Secondary|Area Under the Effect Curve (AUEC)|Area under the effect curve for TNF-alpha induced by LPS and LTB4 induced by fMLP. Results indicate percent change from baseline of TNF-α/LTB4 production. A positive value indicates inhibition of the production.|30 minutes (min) before drug administration and 2 hours (h), 6h, 24h and 48h after drug administration|Treated Set. Summary statistics were not calculated for the 0.5 mg group as there was only one patient in this group. Geometric mean and geometric coefficient of variation was not calculated for any parameter in any dose group in which zero or a negative value was calculated, as geometric means cannot be calculated with negative or zero values.||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
699106|NCT01348165|Secondary|Concentration of Leukotriene B4 (LTB4) Induced by N-formyl-methionine-leucine-phenylalanine (fMLP) in Whole Blood ex Vivo.|Percent of inhibition of fMLP induction of LTB4 production. Concentrations of LTB4 in plasma were determined by an enzyme-linked immunosorbent assay (ELISA). Results indicate percent change from baseline of fMLP induction of LTB4 production. A positive value indicates inhibition of the production.|0.5 hours (h) before drug administration and 2h, 6h, 24h and 48h after drug administration|Treated Set. Summary statistics were not calculated for the 0.5 mg group as there was only one patient in this group.||percentage of LTB4 production||Standard Deviation|Mean
699125|NCT01348139|Secondary|Tmax:Time to Maximum Plasma Concentration|Time to maximum plasma concentration (tmax), for AZD3199 doses|0 - 120 hrs for first two treatment visit 2 and 3 and 0 - 48 hrs for other treatment visits.|PK analysis set||Hours||Full Range|Median
699107|NCT01348165|Secondary|Concentration of Tumour Necrosis Factor-alpha (TNF-α) Induced by Lipopolysaccharide (LPS) in Whole Blood ex Vivo|Concentrations of TNF-α in plasma were determined by an enzyme-linked immunosorbent assay (ELISA). Concentrations of TNF-α in blood drawn after treatment with BI 137882 were compared with those in pre-dose samples to calculate the percent of inhibition of LPS induction of TNF-α production. Results indicate percent change from baseline of LPS-induced TNF-α production. A positive value indicates inhibition of the production.|0.5 hours (h) before drug administration and 2h, 6h, 24h and 48h after drug administration|Treated Set. Summary statistics were not calculated for the 0.5 mg group as there was only one patient in this group.||percentage of TNF-α production||Standard Deviation|Mean
699108|NCT01348165|Secondary|Renal Clearance of BI 137882 From the Time Point t1 Until the Time Point t2|Renal clearance of BI 137882 from the time point t1 until the time point t2 (CLR,t1-t2)|0-4, 4-8, 8-12, and 12-24 hours after drug administration|There was no measurable BI 137882 excreted in urine so this pharmacokinetic parameter was not calculated.|||||
699109|NCT01348165|Secondary|Fraction of BI 137882 Eliminated in Urine From Time Point t1 to Time Point t2|Fraction of BI 137882 eliminated in urine from time point t1 to time point t2 (fet1-t2)|0-4, 4-8, 8-12, and 12-24 hours after drug administration|There was no measurable BI 137882 excreted in urine so this pharmacokinetic parameter was not calculated.|||||
699110|NCT01348165|Secondary|Amount of BI 137882 Eliminated in Urine From the Time Point t1 to Time Point t2|Amount of BI 137882 eliminated in urine from the time point t1 to time point t2 (Aet1-t2)|0-4, 4-8, 8-12, and 12-24 hours after drug administration|There was no measurable BI 137882 excreted in urine so this pharmacokinetic parameter was not calculated.|||||
699111|NCT01348165|Secondary|Apparent Volume of Distribution (Vz/F)|Apparent volume of distribution of the analyte during the terminal phase.|30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration|Treated Set. Descriptive statistics are only presented for treatment groups where the summary statistics were calculated.||L||Geometric Coefficient of Variation|Geometric Mean
699112|NCT01348165|Secondary|Apparent Clearance (CL/F)|Apparent clearance of the analyte in plasma after extravascular administration.|30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration|Treated Set. Descriptive statistics are only presented for treatment groups where the summary statistics were calculated.||mL/min||Geometric Coefficient of Variation|Geometric Mean
699113|NCT01348165|Secondary|Mean Residence Time (MRTpo)|Mean residence time of the analyte in the body after oral administration.|30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration|Treated Set. Descriptive statistics are only presented for treatment groups where the summary statistics were calculated.||hours||Geometric Coefficient of Variation|Geometric Mean
699114|NCT01348165|Secondary|Terminal Rate Constant (λz)|Terminal rate constant in plasma.|30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration|Treated Set. Descriptive statistics are only presented for treatment groups where the summary statistics were calculated.||1/h||Geometric Coefficient of Variation|Geometric Mean
699115|NCT01348165|Secondary|Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 up to the last quantifiable data point.|30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration|Treated Set. Descriptive statistics are only presented for treatment groups where the summary statistics were calculated.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
699116|NCT01348165|Secondary|Terminal Half-life (t1/2)|Terminal half-life of BI 137882 in plasma.|30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration|Treated Set. Descriptive statistics are only presented for treatment groups where the summary statistics were calculated.||hours||Geometric Coefficient of Variation|Geometric Mean
699117|NCT01348165|Secondary|Area Under the Curve 0 to Infinity (AUC0-infinity)|Area under the concentration-time curve of BI 137882 in plasma over the time interval from 0 extrapolated to infinity.|30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration|Treated Set. Descriptive statistics are only presented for treatment groups where the summary statistics were calculated.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
699118|NCT01348165|Secondary|Time to Maximum Measured Concentration (Tmax)|Time from dosing to maximum measured concentration of the analyte in plasma.|30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration|Treated Set. Descriptive statistics are only presented for treatment groups where the summary statistics were calculated.||hours||Full Range|Median
699119|NCT01348165|Secondary|Maximum Measured Concentration (Cmax)|Maximum measured concentration of BI 137882 in plasma.|30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration|Treated Set. Descriptive statistics are only presented for treatment groups where the summary statistics were calculated.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
699120|NCT01348165|Primary|Respiratory Rate (RR)|Change from Baseline to 28 Days in Respiratory rate (RR)|Baseline and 28 days|Treated Set||breaths/min||Standard Deviation|Mean
699121|NCT01348165|Primary|Pulse Rate (PR)|Change from Baseline to 28 Days in Pulse Rate|Baseline and 28 days|Treated Set||bpm||Standard Deviation|Mean
699122|NCT01348165|Primary|Blood Pressure|Change from baseline for systolic blood pressure (SBP) and diastolic blood pressure (DBP)|Baseline and 28 days|Treated Set||mmHg||Standard Deviation|Mean
699123|NCT01348165|Primary|Number of Subjects With Drug Related Adverse Events|Number of subjects with drug related adverse events (AEs)|From baseline up to 28 days|Treated Set which included all subjects who received one dose of trial medication||Participants|||Number
699124|NCT01348139|Secondary|t1/2 :Terminal Half-life|Terminal half-life (t1/2),for AZD3199 doses|0 - 120 hrs for first two treatment visit 2 and 3 and 0 - 48 hrs for other treatment visits.|PK analysis set||Hours||Standard Deviation|Mean
699135|NCT01348100|Secondary|The Average Plasma Concentration (Cav) of Iloperidone Divided by Dose - Phase C|Blood samples for pharmacokinetic (PK) evaluation were drawn pre-dose and at 3, 6, and 12 hours on Day 1; at 0 and 12 hours on Day 2; and on Days 3, 4, 6, 8, 10, 14, 18, 22, and 26 following administration of iloperidone. Blood samples were collected after each depot injection. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. Cav was calculated as AUC0-672h/672 h.|Pre-dose to 26 days post-dose|Pharmacokinetic population: All participants with evaluable pharmacokinetic data.||ng/mL/mg||Standard Deviation|Mean
699136|NCT01348100|Secondary|Area Under the Plasma Concentration-time Curve From 0 to the End of the Dosing Period (AUCtau) of Iloperidone - Phase C|Blood samples for pharmacokinetic (PK) evaluation were drawn pre-dose and at 3, 6, and 12 hours on Day 1; at 0 and 12 hours on Day 2; and on Days 3, 4, 6, 8, 10, 14, 18, 22, and 26 following administration of iloperidone. Blood samples were collected after each depot injection. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. The area under the curve was calculated using a linear trapezoidal method. The end of the dosing period was 672 hours (28 days).|Pre-dose to 26 days post-dose|Pharmacokinetic population: All participants with evaluable pharmacokinetic data.||ng*h/mL||Standard Deviation|Mean
699137|NCT01348100|Secondary|Maximum Observed Plasma Concentration (Cmax) of Iloperidone - Phase C|Blood samples for pharmacokinetic (PK) evaluation were drawn pre-dose and at 3, 6, and 12 hours on Day 1; at 0 and 12 hours on Day 2; and on Days 3, 4, 6, 8, 10, 14, 18, 22, and 26 following administration of iloperidone. Blood samples were collected after each depot injection. PK parameters were calculated from plasma concentration-time data using non-compartmental methods.|Pre-dose to 26 days post-dose|Pharmacokinetic population: All participants with evaluable pharmacokinetic data.||ng/mL||Standard Deviation|Mean
699138|NCT01348100|Secondary|Time to Reach the Maximum Plasma Concentration (Tmax) of Iloperidone - Phase C|Blood samples for pharmacokinetic (PK) evaluation were drawn pre-dose and at 3, 6, and 12 hours on Day 1; at 0 and 12 hours on Day 2; and on Days 3, 4, 6, 8, 10, 14, 18, 22, and 26 following administration of iloperidone. Blood samples were collected after each depot injection. PK parameters were calculated from plasma concentration-time data using non-compartmental methods.|Pre-dose to 26 days post-dose|Pharmacokinetic population: All participants with evaluable pharmacokinetic data.||hours||Full Range|Median
699139|NCT01348100|Secondary|Duration That the Concentration of Iloperidone Was Above 4 ng/mL (Teff) - Phase B|Blood samples for pharmacokinetic (PK) evaluation were drawn pre-dose and at 3, 6, and 12 hours on Day 1; at 0 and 12 hours on Day 2; and on Days 3, 4, 6, 8, 10, 14, 18, 22, and 26 following administration of iloperidone. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. The duration that the concentration of iloperidone was above 4 ng/mL was calculated by linear interpolation. PK/pharmacodynamic analysis performed in other studies suggests that iloperidone plasma levels of 4 ng/mL or above provide clinical efficacy.|Pre-dose to 26 days post-dose|Pharmacokinetic population: All participants with evaluable pharmacokinetic data.||hours||Full Range|Median
699140|NCT01348100|Secondary|The Average Plasma Concentration (Cav) of Iloperidone - Phase B|Blood samples for pharmacokinetic (PK) evaluation were drawn pre-dose and at 3, 6, and 12 hours on Day 1; at 0 and 12 hours on Day 2; and on Days 3, 4, 6, 8, 10, 14, 18, 22, and 26 following administration of iloperidone. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. Cav was calculated as AUC0-672h/672 h.|Pre-dose to 26 days post-dose|Pharmacokinetic population: All participants with evaluable pharmacokinetic data.||ng/mL||Standard Deviation|Mean
699141|NCT01348100|Secondary|Area Under the Plasma Concentration-time Curve From 0 to the Last Measurable Concentration (AUClast) of Iloperidone - Phase B|Blood samples for pharmacokinetic (PK) evaluation were drawn pre-dose and at 3, 6, and 12 hours on Day 1; at 0 and 12 hours on Day 2; and on Days 3, 4, 6, 8, 10, 14, 18, 22, and 26 following administration of iloperidone. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. The area under the curve was calculated using a linear trapezoidal method.|Pre-dose to 26 days post-dose|Pharmacokinetic population: All participants with evaluable pharmacokinetic data.||ng*h/mL||Standard Deviation|Mean
699142|NCT01348100|Secondary|Area Under the Plasma Concentration-time Curve From 0 to the End of the Dosing Period (AUCtau) of Iloperidone - Phase B|Blood samples for pharmacokinetic (PK) evaluation were drawn pre-dose and at 3, 6, and 12 hours on Day 1; at 0 and 12 hours on Day 2; and on Days 3, 4, 6, 8, 10, 14, 18, 22, and 26 following administration of iloperidone. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. The area under the curve was calculated using a linear trapezoidal method. The end of the dosing period was 672 hours (28 days).|Pre-dose to 26 days post-dose|Pharmacokinetic population: All participants with evaluable pharmacokinetic data.||ng*h/mL||Standard Deviation|Mean
699143|NCT01348100|Secondary|Maximum Observed Plasma Concentration (Cmax) of Iloperidone - Phase B|Blood samples for pharmacokinetic (PK) evaluation were drawn pre-dose and at 3, 6, and 12 hours on Day 1; at 0 and 12 hours on Day 2; and on Days 3, 4, 6, 8, 10, 14, 18, 22, and 26 following administration of iloperidone. PK parameters were calculated from plasma concentration-time data using non-compartmental methods.|Pre-dose to 26 days post-dose|Pharmacokinetic population: All participants with evaluable pharmacokinetic data.||ng/mL||Standard Deviation|Mean
699144|NCT01348100|Secondary|Time to Reach the Maximum Plasma Concentration (Tmax) of Iloperidone - Phase B|Blood samples for pharmacokinetic (PK) evaluation were drawn pre-dose and at 3, 6, and 12 hours on Day 1; at 0 and 12 hours on Day 2; and on Days 3, 4, 6, 8, 10, 14, 18, 22, and 26 following administration of iloperidone. PK parameters were calculated from plasma concentration-time data using non-compartmental methods.|Pre-dose to 26 days post-dose|Pharmacokinetic population: All participants with evaluable pharmacokinetic data.||hours||Full Range|Median
699145|NCT01348100|Primary|The Average Plasma Concentration (Cav) of Iloperidone - Phase C|Blood samples for pharmacokinetic (PK) evaluation were drawn pre-dose and at 3, 6, and 12 hours on Day 1; at 0 and 12 hours on Day 2; and on Days 3, 4, 6, 8, 10, 14, 18, 22, and 26 following administration of iloperidone. Blood samples were collected after each depot injection. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. Cav was calculated as AUC0-672h/672 h.|Pre-dose to 26 days post-dose|Pharmacokinetic population: All participants with evaluable pharmacokinetic data.||ng/mL||Standard Deviation|Mean
699174|NCT01347840|Primary|Percent Excess Weight Loss|Calculated as the difference between the baseline weight and weight at endpoint divided by the difference between baseline weight and ideal body weight using the medium frame range in the Metropolitan Tables for Life Insurance, 1983 x 100.|16 months|||percentage of excess weight|||Number
699146|NCT01348100|Primary|Maximum Observed Plasma Concentration (Cmax) of Iloperidone Divided by the Average Plasma Concentration (Cav) of Iloperidone (Cmax/Cav) - Phase B|Blood samples for pharmacokinetic (PK) evaluation were drawn pre-dose and at 3, 6, and 12 hours on Day 1; at 0 and 12 hours on Day 2; and on Days 3, 4, 6, 8, 10, 14, 18, 22, and 26 following administration of iloperidone. PK parameters were calculated from plasma concentration-time data using non-compartmental methods.|Pre-dose to 26 days post-dose|Pharmacokinetic population: All participants with evaluable pharmacokinetic data.||Ratio of Cmax to Cav||Standard Deviation|Mean
699147|NCT01348087|Primary|Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs).|Adverse events were summarized for the open-label treatment period, where the open-label treatment period is defined based on how AEs were collected and reported according to the manner in which patients entered the current study and which treatment (AFQ056 or placebo) they were receiving in the previous study. AEs which were continuing from the core study or that started after the end of core study but prior to first dose of open-label study medication in the extension study for Category 1 patients are shown under (‘Prior to Ext. first dose’). AEs which started during the open-label treatment period are presented based on the last AFQ056 dose taken on or before the onset date of the AE (25 mg bid; 50 mg bid; 75 mg bid; or 100 mg bid). No efficacy data presented as study was terminated|Prior to first dose in extension study, Baseline (start of study treatment in extension study) to End of trial|The analysis was performed in the safety set (SS) population, defined as participants who received at least one dose of study medication and had at least one safety assessment occurring after first dose of extension study medication. Here, 'Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure||Participants|||Number
699148|NCT01347931|Secondary|Borg Dyspnea Score|"Borg Dyspnea score is measured using a 11-point visual analog scale. The lower the score on the scale, the less breathlessness patient experiences. The score ranges from:
0 = No breathlessness at all, representing better outcome 10 = Maximum, representing worse outcome"|Measured during activity testing in a single day study visit|Per Protocol||units on a scale||95% Confidence Interval|Median
699149|NCT01347931|Secondary|Arterial Oxygen Saturation|O2 saturation measured by pulse oximetry|Measured during activity testing in a single day study visit|Per Protocol||percentage of oxyHb saturation||Standard Deviation|Mean
699150|NCT01347931|Primary|Activity Endurance Time|Time in minutes of sustained activity while using test treatments|Measured during single day study visit|Per Protocol||minutes||Standard Deviation|Mean
699151|NCT01347879|Secondary|Severe and Very Severe Scarring According to Scarring Score|Clinical assessment using a 6 point scale; Clear, Almost clear, Mild, Moderate, Severe and Very severe|at week 12 after first treatment|100 patients were included and 83 patients completed the study in the Visonac treatment arm. However, a few patients came back for the week 12 visit only, and have data for scarring. The total number of patients with scarring data at 12 weeks in this group is 91.||participants|||Number
699152|NCT01347879|Secondary|Mild and Moderate Scarring According to Scarring Score|Clinical assessment using a 6 point scale; Clear, Almost clear, Mild, Moderate, Severe and Very severe|at week 12 after first treatment|100 patients were included and 83 patients completed the study in the Visonac treatment arm. However, a few patients came back for the week 12 visit only, and have data for scarring. The total number of patients with scarring data at 12 weeks in this group is 91.||participants|||Number
699153|NCT01347879|Secondary|Erythema Score of Severe|Clinical assessment using a 4 point scale; none, mild, moderate, severe|2 days after first treatment|Of the 100 patients who were included in the Visonac treatment arm, 5 dropped out prior to the day 2 erythema assessment. The number of patients with erythema data at this assessment point is 95.||participants|||Number
699154|NCT01347879|Secondary|Erythema Score of Mild and Moderate|Clinical assessment using a 4 point scale; none, mild, moderate, severe|2 days after first treatment|Of the 100 patients who were included in the Visonac treatment arm, 5 dropped out prior to the day 2 erythema assessment. The number of patients with erythema data at this assessment point is 95.||participants|||Number
699155|NCT01347879|Secondary|Erythema Score of Severe|Clinical assessment using a 4 point scale; none, mild, moderate, severe|Immediately after first treatment|||participants|||Number
699156|NCT01347879|Secondary|Percent Change From Baseline in Facial Non-inflammatory Lesion Count (Open and Closed Comedones)||From baseline to 12 weeks after first treatment|||percent change||Full Range|Median
699157|NCT01347879|Secondary|Clear and Almost Clear Scarring According to Scarring Score|Clinical assessment using a 6 point scale; Clear, Almost clear, Mild, Moderate, Severe and Very severe|at week 12 after first treatment|100 patients were included and 83 patients completed the study in the Visonac treatment arm. However, a few patients came back for the week 12 visit only, and have data for scarring. The total number of patients with scarring data at 12 weeks in this group is 91.||participants|||Number
699158|NCT01347879|Secondary|Erythema Score of Mild and Moderate|Clinical assessment using a 4 point scale; none, mild, moderate, severe|Immediately after first treatment|||participants|||Number
699159|NCT01347879|Secondary|Number of Patients With Adverse Events.||From administration of investigational medicinal product (IMP) until 12 weeks after first IMP administration|||participants|||Number
699160|NCT01347879|Secondary|Pain During Illumination.|Pain during illumination was assessed by patient using a Visual Analogue Scale (VAS) from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable.|Immediately after first treatment|||VAS score in cm||Full Range|Mean
699161|NCT01347879|Secondary|Proportion of Patients With Success According to IGA Scale Based on the Facial Assessment.|One Investigator Global Assessment (IGA) scale was used including inflammatory and non-inflammatory lesions. The investigator qualitatively graded the overall acne severity on a scale from 0 to 4, with 4 being the most severe. Success was defined as an improvement of at least 2 grades from the baseline score.|From baseline to 12 weeks after first treatment|||participants|||Number
699162|NCT01347879|Secondary|Percent Change From Baseline in Facial Inflammatory (Nodules, Papules, and Pustules)Lesion Counts.||From baseline to 12 weeks after the first treatment|||percent change||Full Range|Median
699163|NCT01347879|Secondary|Absolute Change From Baseline in Facial Non-inflammatory Lesion Count (Open and Closed Comedones)||From baseline to 12 weeks after the first treatment|||lesion count||Standard Deviation|Mean
699164|NCT01347879|Primary|Absolute Change From Baseline in Facial Inflammatory Lesion Count (Nodules, Papules, and Pustules).||From baseline to 12 weeks after first treatment|||lesion count||Standard Deviation|Mean
699175|NCT00000125|Primary|Incidence of Primary Open-Angle Glaucoma in Hypotensive Patients|Comparison of the cumulative proportion of participants who develop primary open-angle glaucoma in the observation and medication groups.|5 yrs (OHTS I, June 2002) and 13.0 yrs (completion of both phases of OHTS, March 2009)|1636 ocular hypertensive participants were randomized to either close observation or treatment with topical hypotensive eyedrops from February 1994 through June 2002. In June 2002 the observation participants were offered treatment with topical hypotensive eyedrops.||percent of participants|||Number
699176|NCT00000134|Primary|Morbidity|To determine the best therapeutic regimen, using currently approved drugs, for treatment of relapsed cytomegalovirus (CMV) retinitis.|Patients will be seen at baseline, monthly for six months, and then every three months until death or termination of the trial|||participants|||Number
699177|NCT00000135|Primary|Mortality Rate|to evaluate the efficacy of an intravenous human monoclonal antibody to cytomegalovirus (CMV), MSL-109, as adjuvant treatment for CMV retinitis. .|All patients enrolled were followed for a 17 month period or until a common study closing date|||deaths per person-year|||Number
699178|NCT00000136|Primary|Mortality||All patients enrolled will be followed until a common study closing date, which was chosen to provide a minimum of 1 year of follow-up for all patients enrolled in the trial.|||participants|||Number
699179|NCT00000142|Primary|Survival||All patients enrolled will be followed until a common study closing date|||participants|||Number
699180|NCT00000143|Primary|Survival||3 years|||participants|||Number
699181|NCT00000371|Primary|Scale for the Assessment of Negative Symptoms (SANS)|The slope of SANS total score from baseline to week 8 in the treatment and placebo groups on the scale for the assessment of negative symptoms (SANS) total score. Total SANS scores range from 0-100. The SANS is comprised of 5 subscores: Affective Flattening or Blunting (score range 0-35), Alogia (score range 0-20), Avolition-Apathy (score range 0-15), Anhedonia-Asociality (score range 0-20), and Attention (0-10). For each scale, the higher the score the more prominent the negative symptoms were. The slopes were obtained by plotting the group SANS total score mean for treatment vs. placebo on Baseline, Week 4, and Week 8 and performing a random slopes model.|Baseline, Week 4, Week 8|||units on a scale/weeks||Standard Error|Mean
699182|NCT00000378|Primary|HAMILTON Rating Scale for DEPRESSION Range|Hamilton scale range 0-40, values below 7 are considered normal. the higher the number the more severe the depression weekly assessments, The primary outcome is a comparison of the baseline Hamilton to the 12 week measurement|BASELINE COMPARED TO 12 WEEK MEASUREMENT|intent to treat analysis||units on a scale||Standard Deviation|Mean
699183|NCT00000392|Secondary|Change in Neurocognitive Performance Domain z Scores From Baseline|Higher values for change in z-score represent an improvement in Neurocognitive Performance (NP)|Baseline and 6 months|||z score||Standard Error|Mean
699184|NCT00000392|Primary|Change in Global Neurocognitive Performance z Score From Baseline|Higher values for change in z-score represent an improvement in Neurocognitive Performance (NP)|Baseline and 6 months|||z score||Standard Error|Mean
699185|NCT00000479|Primary|Number of Participants With Cancer, Excluding Nonmelanoma Skin Cancer||Average follow-up 10.1 years|||participants|||Number
699186|NCT00000479|Primary|Number of Participants With Major Cardiovascular Events (a Combined Endpoint of Nonfatal Myocardial Infarction, Nonfatal Stroke, and Total Cardiovascular Death)||Average follow-up 10.1 years|||Participants|||Number
699187|NCT00000575|Secondary|Standardized Depression Scale -- Children's Depression Inventory|Change in total score on the Children's Depression Inventory from baseline to the end of treatment, 4-6 years later. The total score ranges from 0-54 with higher scores indicating greater levels of depression.|4-6 years from baseline|||units on a scale||Standard Deviation|Mean
699188|NCT00000575|Secondary|Change in Height From Baseline to End of Treatment, 4-6 Years Later|Change in standing height from baseline to end of treatment. Standing height is measured three times without shoes using a calibrated Harpenden stadiometer; the average of the three repeated heights to the nearest 0.1 cm is the height measure at either baseline or end of treatment.|4-6 years from baseline|||cm||Standard Deviation|Mean
699189|NCT00000575|Secondary|Mortality|Counts of deaths from asthma.|4-6 years from baseline|||participants|||Number
699190|NCT00000575|Secondary|Need for Urgent Care for Asthma|Counts during the period of treatment (4-6 years) of visits to emergency rooms or equivalent urgent care settings for asthma treatment.|4-6 years from baseline|||rate per 100 person years|||Number
699191|NCT00000575|Secondary|Change From Baseline in the Rate of Asthma Free Days|Change from baseline proportion of days without asthma symptoms or other asthma related events to proportion of days during the 4-6 years of follow-up. Asthma free days were determined from daily asthma diaries kept from baseline to the end of treatment, 4-6 years later.|4-6 years from baseline|||days per month||Standard Deviation|Mean
699192|NCT00000575|Secondary|Bronchial Responsiveness to Serial Methacholine Concentrations Inhaled Into the Lungs|Bronchial responsiveness to serial concentrations of inhaled methacholine solution (mg/ml) as measured by serial ratios of follow-up to baseline FEV1 (forced volume of air expired from the lungs in one second). A dose-response curve is calculated from the serial ratios in relation to the serial concentrations to determine PC20, the concentration associated with a 20% drop from baseline in FEV1; this PC20 is the outcome measure with units mg/ml of methacholine.|4-6 years from baseline|||mg/ml of methacholine||Standard Deviation|Geometric Mean
699193|NCT00000575|Primary|Pulmonary Function as Measured by Normalized FEV1 Over a 4-6 Year Period|Change in FEV1 % of predicted, post-bronchodilator use, from baseline to the end of treatment (4-6 years after randomization). Percent predicted determined from three separate published sets of reference equations for white, black, and Hispanic children - see NEJM 343: 1054-1062, 2000 for more details and references.|At the end of treatment, 4-6 years from baseline assessment|||percentage of predicted value||Standard Deviation|Mean
699194|NCT00000620|Secondary|First Occurrence of MCE or Revascularization or Hospitalization for Congestive Heart Failure (CHF) in Lipid Trial.|Time to first occurrence of nonfatal myocardial infarction, nonfatal stroke, cardiovascular death, revascularization procedure or hospitalization for CHF in Lipid Trial participants.|4.7 years|The population analyzed included all participants randomized and was performed by intention to treat with right-censoring of participants who did not complete follow-up prior occurrence of event.||participants|||Number
699210|NCT00001575|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|16 yrs 18 days|||participants|||Number
699195|NCT00000620|Primary|First Occurrence of Major Cardiovascular Event (MCE) in the Lipid Trial.|Time to first occurrence of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death in Lipid Trial participants.|4.7 years|The population analyzed included all participants randomized and was performed by intention to treat with right-censoring of participants who did not complete follow-up prior to occurrence of MCE.||participants|||Number
699196|NCT00000620|Secondary|Stroke in the Blood Pressure Trial.|Time to first occurrence of nonfatal or fatal stroke among participants in the BP Trial.|4.7 years|The population analyzed included all participants randomized and was performed by intention to treat with right-censoring of participants who did not complete follow-up prior to occurrence of stroke.||participants|||Number
699197|NCT00000620|Primary|First Occurrence of Major Cardiovascular Event (MCE) in the Blood Pressure Trial.|Time to first occurrence of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death. Primary outcome for Blood Pressure Trial.|4.7 years|The population analyzed included all participants randomized and was performed by intention to treat with right-censoring of participants who did not complete follow-up prior to occurrence of MCE.||participants|||Number
699198|NCT00000620|Secondary|Death From Any Cause in the Glycemia Trial.|"Time to death from any cause. Secondary measure for Glycemia Trial.
A finding of higher mortality in the intensive-therapy group led to an early discontinuation of therapy after a mean of 3.5 years of follow-up. Intensive arm participants were transitioned to standard arm strategy over a period of 0.2 year and followed for an additional 1.2 years to the planned end of the Glycemia Trial while participating in one of the other sub-trials (BP or Lipid)."|4.9 years|The population analyzed included all participants randomized and was performed by intention to treat with right-censoring of participants who did not complete follow-up prior to death.||participants|||Number
699199|NCT00000620|Primary|First Occurrence of a Major Cardiovascular Event (MCE); Specifically Nonfatal Heart Attack, Nonfatal Stroke, or Cardiovascular Death (Measured Throughout the Study) in the Glycemia Trial.|"Time to first occurrence of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death. This was the primary outcome measure in all three trials: Glycemia (all participants), Blood Pressure (subgroup of participants not in Lipid Trial), and Lipid (subgroup of participants not in Blood Pressure Trial).
In the Glycemia Trial, a finding of higher mortality in the intensive arm group led to an early discontinuation of therapy after a mean of 3.5 years of follow-up. Intensive arm participants were transitioned to standard arm strategy over a period of 0.2 year and followed for an additional 1.2 years to the planned end of the Glycemia Trial while participating in one of the other sub-trials (BP or Lipid) to their planned completion."|4.9 years|The population analyzed included all participants randomized and was performed by intention to treat with right-censoring of participants who did not complete follow-up prior to occurrence of MCE.||participants|||Number
699200|NCT00001151|Primary|Number of Participants With Normal Serum Calcium Concentrations|Normal calcium concentration 8.2-10.6 mg/dL|1 year average|||participants|||Number
699201|NCT00001566|Secondary|Median Overall Survival|Overall survival is defined as the time between the first day of treatment to the day of death.|5.4 years|||Years||Full Range|Median
699202|NCT00001566|Primary|Number of Participants With an Immune Response to Tumor-Specific Peptides at the Time of Presentation|Immune response was defined as a percent specific lysis of >10% following challenge with tumor peptide pulsed targets, or interferon gamma production following challenge with tumor peptide pulsed targets >2-fold that found with no-peptide controls or a proliferation index >3.0 to tumor peptide targets.Tumor specific peptides: Ewings sarcoma Type 1: EF-1 (EWS/FLI-1)*SSSYGQQN/PSYDSVRRGA,Ewing's Sarcoma Type 2: EF-2 (EWS/FLI-2)* SSSYGQ/QSSLLAYNT, Alveolar rhabdomyosarcoma: PXFK (PAX3/FKHR)† TIGNGLSPQ/NSIRHNLSL. See protocol link module for additional information re: peptides.|Once per enrollment|||Participants|||Number
699203|NCT00001566|Primary|Number of Participants With an Immune Response to Non-Tumor-specific Peptide E7|Immune response was defined as a percent specific lysis of >10% following challenge with peptide pulsed targets, or interferon gamma production following challenge with peptide pulsed targets >2-fold that found with no-peptide controls or a proliferation index >3.0.|5 years|12 patients were human leukocyte antigen serotype within HLA-A A serotype group (HLA-A2+) and therefore evaluable for response to E7 peptides.||Participants|||Number
699204|NCT00001566|Secondary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|5 years|||Participants|||Number
699205|NCT00001566|Secondary|Percent of Participants: Event Free Survival|Event free survival is calculated from the date of diagnosis for patients enrolled with newly diagnosed metastatic disease and from the date of the last recurrence detection before enrollment on this study for patients with recurrent disease.|5 years|||Percentage of participants|||Number
699206|NCT00001566|Secondary|Percentage of Participants Overall Survival|Overall survival is defined as the time between the first day of treatment to the day of death.|5 years|||Percentage of participants|||Number
699207|NCT00001566|Primary|Number of Participants With an Immune Response to the Translocation Breakpoint Peptide|Immune responses were measured following 3 sequential influenza vaccines during the same period as the peptide-pulsed dendritic cell vaccines.|5 years|||Participants|||Number
699208|NCT00001566|Primary|The Percent of Patients Who Recover CD4 Counts Within 6 Months of Completion of Chemotherapy|CD4 counts were measured from peripheral blood using standard flow cytometric techniques at the following timepoints: 2 months post-chemotherapy, 4 months post-chemotherapy and 6 months post-chemotherapy. To be eligible for evaluation for this endpoint, patient much have been <10 years of age and sustained a CD4 count of <300 cells/mcl upon completion of standard therapy. Recovery was defined as a CD4 count > 500 cells/mcl at any timepoint within 6 months of completing chemotherapy.|2 to 6 months|||Percentage of participants|||Number
699209|NCT00001566|Primary|Number of Participants With an Immune Response to Tumor-specific and Non-tumor Specific Peptides During a Period of Immune Reconstitution|Immune response was defined as a percent specific lysis of >10% following challenge with peptide pulsed targets, or interferon gamma production following challenge with peptide pulsed targets >2-fold that found with no-peptide controls or a proliferation index >3.0. Tumor specific peptides: Ewings sarcoma Type 1: EF-1 (EWS/FLI-1)*SSSYGQQN/PSYDSVRRGA,Ewing's Sarcoma Type 2: EF-2 (EWS/FLI-2)* SSSYGQ/QSSLLAYNT, Alveolar rhabdomyosarcoma: PXFK (PAX3/FKHR)† TIGNGLSPQ/NSIRHNLSL. Non-tumor specific peptide:HPV16E7 MLDLQPETT-MET-9-THR. See protocol link module for additional information re: peptides.|20 weeks post vaccination|||Participants|||Number
699211|NCT00001575|Primary|Clinical Response|Clinical Response of patient is measured by the Response Evaluation Criteria in Solid Tumors (RECIST). Tumor responses were evaluated by In-HAT imaging (i.e., simultaneous with administration of therapeutic 90Y-daclizumab), Fludeoxyglucose (18F) positron-emission tomography (FDG PET) scans and computed tomography (CT) scans. Complete response is a disappearance of all measurable and evaluable disease lasting more than I month. Partial response is a reduction by ≥ 50% of leukemic cell count or ≥ 50% reduction in the size of all measurable lesions, and no increase in size of any measurable or evaluable lesion or appearance of new lesions for 1 month. Stable disease is less than partial response with no more than a 25% increase in leukemic cell count, no new lesions, or less than a 25% increase in any measurable lesion. Progressive disease is at least a 25% increase in leukemic cell count, appearance of new lesions, or an increase of 25% or greater in any measurable lesion after 2 weeks.|Patient would be measured with computed tomography (CT) scan, Fludeoxyglucose (18F) positron-emission tomography (FDG PET) scan in 28 days before treatment. Patient would be evaluated with In-HAT imaging at Day 1,4,5,6 and Day 7 in week 1 of each cycle.|Phase II portion. Only the Hodgkin's participants was analyzed (i.e., added more Hodgkins participants to study).||participants|||Number
699212|NCT00001575|Primary|Maximum Tolerated Dose (MTD) of 90Y-HAT|Phase I portion maximum tolerated dose (MTD) is defined as the dose level below the dose at which 2 out of 2-6 patients develop DLT (if any patient develops grade IV toxicity of any type (excluding grade IV neutropenia) or grade III non-hematologic toxicity that patient may not continue on the study at the same dose level and therefore has had a dose limiting toxicity). There can be no more than 1 out of 6 patients with DLT at the MTD. The MTD will be assessed using only the results from the first cycle of therapy.|Patients could receive 90Y-HAT 15mCi per cycle and complete up to a maximum of 7 doses or 2 doses by the average of every 6 weeks.|Phase I portion-maximum tolerated dose. Only the Hodgkin's participants was analyzed (i.e., 28).||mci|||Number
699213|NCT00001586|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|13 years, 10.5 months|The low-intermediate risk patients received no treatment so their tissue/blood was not analyzed for change.||Participants|||Number
699214|NCT00001586|Primary|Change in Gene Expression Post Chemo|Changes in lymphocyte gene expression was measured by deoxyribonucleic acid (DNA) microarray analysis of circulating leukemic cells after completion of study treatment. A change in expression is defined as a >50% increase in circulating leukemic cells or a 30% decrease in circulating leukemic cells.|6 hours post treatment, and 24 hours post treatment|There were only 12 patients analyzed for various reasons such as timing of treatment, ability to collect samples, and viability of samples.||Percent change in cells|||Number
699223|NCT00001656|Other Pre-specified|Change in Extrapyramidal Movements as Measured by the Simpson Angus Scale Score|minimum score = 10; maximum score = 90; lower score considered a more favorable outcome|8 week double-blind study period; baseline and 8 weeks|||scores on a scale||95% Confidence Interval|Median
724713|NCT00346632|Secondary|Observed Peak Plasma Concentration (Cmax)||Days 1 and 14 (and Day 28 for Arm B) of Cycle 1|||ng/mL||Standard Deviation|Mean
699227|NCT00001656|Primary|Change in the Bunney-Hamburg Rating Scale for Anxiety|Measures change in the severity of anxiety; Minimum score = 0; maximum score = 7; lower score is considered a better outcome.|8 week double-blind study period; baseline and 8 weeks|||Scores on a scale||95% Confidence Interval|Mean
699228|NCT00001656|Primary|Change in Bunney-Hamburg Rating Scale for Mania|Measures change in the severity of mania; Minimum score = 0; maximum score = 7; lower score is considered a better outcome.|8 week double-blind study period; baseline and 8 weeks|||Scores on a scale||95% Confidence Interval|Mean
699229|NCT00001656|Primary|Change in Bunney-Hamburg Rating Scale for Depression|Measures change in severity of depression; Minimum score = 0; maximum score = 7; lower score is considered a better outcome.|8 week double-blind study period; baseline and 8 weeks|||Scores on a scale||95% Confidence Interval|Mean
699230|NCT00001656|Primary|Change in the Bunney-Hamburg Rating Scale for Psychosis|Measures change in psychosis severity; Minimum score = 0; maximum score = 7; lower score is considered a better outcome.|8 week double-blind study period; baseline and 8 weeks|||Scores on a scale||95% Confidence Interval|Mean
699231|NCT00001656|Primary|Change in the Scale for the Assessment of Positive Symptoms|Measures change in hallucinations, delusions, bizarre behavior, and thought organization. Minimum score = 0; maximum score = 170; lower score is considered a better outcome.|8 week double-blind study period; baseline and 8 weeks|||Scores on a scale||95% Confidence Interval|Mean
699232|NCT00001656|Primary|Change in the Brief Psychiatric Rating Scale-24|A 24-item scale measuring change in interpersonal behaviors, mood, psychosis, anxiety, speech, sleep, orientation and physical activity. Lowest score = 24; highest score = 168; lower score is considered a better outcome.|8 week double-blind study period; baseline and 8 weeks|||Scores on a scale||95% Confidence Interval|Mean
699233|NCT00001656|Primary|Change in the Clinical Global Impression Severity of Symptoms Scale|Measures change in the severity of symptoms; Minimum score = 1; maximum score = 7; lower score is considered a better outcome.|8 week double-blind study period; baseline and 8 weeks|||Scores on a scale||95% Confidence Interval|Mean
699234|NCT00001656|Primary|Change in the Scale for the Assessment of Negative Symptoms|Measures change in affective flattening or blunting, alogia, avolition/apathy, anhedonia/asociality, attention; minimum score = 0; maximum score = 125; lower values are considered a better outcome|8 week double-blind study period; baseline and 8 weeks|||Scores on a scale||95% Confidence Interval|Mean
699235|NCT00001703|Secondary|The Number of Participants With Adverse Events.|Here are the total number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|88 months|||participants|||Number
699236|NCT00001703|Primary|Percentage of Participants Who Generated an Immune Response|The immunological response was assessed by in-vitro T cell cytokine production enzyme-linked immunosorbent spot (ELISPOT). From each patients, post-vaccination peripheral blood mononuclear cells (PBMC) were compared to pre-vaccination as a baseline. A positive ELISPOT result for the patients was defined as a total number of experimental spots in the post-vaccination sample of more than twofold above the total spots in the pre-vaccination sample.|30 months|||percentage of participants|||Number
699237|NCT00001723|Secondary|Effect of Race on Change in Weight (kg)|Difference in change of weight in kg according to race (Non-Hispanic White versus Non-Hispanic Black)|baseline to 6 months|Multiple imputation analysis||kg||Standard Error|Mean
699238|NCT00001723|Secondary|Change in Body Fat (kg)|body fat distribution measures obtained from Dual-energy X-ray Absorptiometry (DEXA)|baseline to 6 months|Multiple Imputation analysis||kg||Standard Error|Mean
699239|NCT00001723|Secondary|Change in Body Mass Index|BMI is calculated in kg/m2. Change from baseline to 6 months of treatment|baseline to 6 months|Muliple imputation analysis||kg per square meter||Standard Error|Mean
699240|NCT00001723|Secondary|Change in Body Weight|Weight in kg|baseline to 6 months|Multiple imputation analysis||kg||Standard Error|Mean
699241|NCT00001723|Primary|Change in BMI Standard Deviation Score|Body Mass index standard deviation score calculated for age and sex according to Centers for Disease Control standards. See: Kuczmarski RJ, Ogden CL, Guo SS, Grummer-Strawn LM, Flegal KM, Mei Z et al. 2000 CDC Growth Charts for the United States: methods and development. Vital Health Stat 11 2002; (246): 1-190.|baseline to 6 months|Multiple imputation analysis||Standard Deviation Score||Standard Error|Mean
699242|NCT00001941|Primary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|12 months|Data is not available separately per cohort.||Participants|||Number
699243|NCT00001941|Primary|Percentage of Participants With an Overall Response Rate|Participants overall response rate was defined as complete response (CR) + partial response (PR) from study consent until progression was measured. Responses was assessed by a modified World Health Organization (WHO) criteria. Partial response is a reduction of >=50% saturation in the circulating leukemic cell count; complete response is disappearance of all measurable and non-measurable disease lasting more than 1 month; and progressive disease is a >=25% increase in leukemic cell count|up to 220 weeks|Phase I is not reported because phase I studies only determine maximum tolerated dose.||Percentage of participants|||Number
699244|NCT00001941|Primary|Overall Survival|Measured from the time the patient is consented until death.|132.6 weeks|Phase I is not reported because phase I studies only determine maximum tolerated dose.||Weeks||95% Confidence Interval|Median
699245|NCT00001941|Primary|Duration of Response|Duration of response was defined as the interval from the time response is first achieved to the time progression from the best response is detected. Responses are assessed by a modified World Health Organization (WHO) criteria. Partial response is a reduction of >=50% saturation in the circulating leukemic cell count; complete response is disappearance of all measurable and non-measurable disease lasting more than 1 month; stable disease is patients who did not meet the criteria; and progressive disease is a >=25% increase in leukemic cell count.|21-220 weeks|Phase I is not reported because phase I studies only determine maximum tolerated dose.||Weeks||Full Range|Median
699246|NCT00001959|Secondary|Proportion of Patients With Positive Change in GFR||12 months from baseline|||participants|||Number
699247|NCT00001959|Secondary|Proteinuria After Treatment||12 months from baseline|||g/d||Inter-Quartile Range|Median
699248|NCT00001959|Primary|Decrease in GFR During Treatment Period||12 months from baseline|ITT||ml/min/1.73 m2||Inter-Quartile Range|Mean
699249|NCT00001962|Secondary|Change in the Transfusion Requirements, Overall Survival.||3 and 6 months||||||
699250|NCT00001962|Primary|Daclizumab Hematologic Response|"Daclizumab, 1 mg/kg of body weight, will be given for a total of 5 intravenous infusions to subjects diagnosed with moderate aplastic anemia (MAA), pure red cell aplasia (PRCA), Diamond Blackfan anemia (DBA), relapse and refractory severe aplastic anemia (SAA) will receive treatment. The Diamond Blackfan anemia arm was closed due to the lack of accrual. The hematologic response will be evaluated at 3 months.
A complete hematologic response will be considered an achievement of normal blood counts. A partial response was defined as any response less than a complete response. The primary endpoint was a hematologic response in at least one affected peripheral blood count parameter, as determined by 3 separate measurements in the first 12 weeks after completion of the infusion."|3 months|The daclizumab hematologic response was evaluated for subjects diagnosed with moderate aplastic anemia (MAA) and pure red cell aplasia (PRCA). The Diamond Blackfan arm was closed due to lack of accrual.||participants|||Number
699251|NCT00001984|Secondary|Monocyte Count||4 day post operation|||cells/mm3||Full Range|Median
699252|NCT00001984|Primary|Rise in Serum Creatineine Above Posttransplant Nadir||24-32 days post operation|||parcentage rise in serum creatineine||Full Range|Median
699253|NCT00001984|Secondary|Creatinine at 2 Years|Creatinine level of donor recepient at 2 years after transplantation|2 years post operation|||mg/dL||Standard Deviation|Mean
699254|NCT00001984|Secondary|Creatinine Level at Year 1 Post Operation||1 year post operation|||mg/dL||Standard Deviation|Mean
699255|NCT00001984|Secondary|Creatinine Level at 6 Month Post Operation||6 month post operation|||mg/dL||Standard Deviation|Mean
699256|NCT00001984|Primary|Rejection Day of Onset|The day on which the rejection onsets.|From day 1 to 2 years post operation|||day||Full Range|Median
699257|NCT00001984|Primary|Number of Patients With Renal Allograft Rejection|The renal allograft tolerance was evaluated clinically, by flow cytometry, and by protocol biopsies analyzed immunohistochemically and with real-time polymerase chain reaction.|from day 1 to 24 months post operation|||participant|||Number
699258|NCT00001262|Secondary|Somatic Growth Percentiles at 3 Years of Age (or at Age of Death) - Head Circumference Percentile||36 months or death|||Other - Percentile||Standard Deviation|Mean
699259|NCT00001262|Secondary|Somatic Growth Percentiles at 3 Years of Age (or at Age of Death) - Length Percentile||36 months or death|||Other - Percentile||Standard Deviation|Mean
699260|NCT00001262|Secondary|Somatic Growth Percentiles at 3 Years of Age (or at Age of Death) - Weight Percentile||36 months or death|||Other - Percentile||Standard Deviation|Mean
699261|NCT00001262|Primary|Language Development at 36 Mos of Age or at Death (Mos)|This was measured based on the Denver Developmental Screening Test (DDST) I or II for age-appropriate language development in apparently normal healthy subjects at specific ages (in months). The DDST employs a grid to assess expected developmental milestones in relation to chronologic age.|36 months or death|||Other - Months||Standard Deviation|Mean
699262|NCT00001262|Primary|Personal-Social Development at 36 Mos of Age or at Death (Mos)|This was measured based on the Denver Developmental Screening Test (DDST) I or II for age-appropriate personal-social development in apparently normal healthy subjects at specific ages (in months). The DDST employs a grid to assess expected developmental milestones in relation to chronologic age.|36 months or death|||Other - Months||Standard Deviation|Mean
699263|NCT00001262|Primary|Fine Motor Adaptive Development at 36 Mos of Age or at Death (Mos)|This was measured based on the Denver Developmental Screening Test (DDST) I or II for age-appropriate fine motor development in apparently normal healthy subjects at specific ages (in months). The DDST employs a grid to assess expected developmental milestones in relation to chronologic age.|36 months or death|||Other - Months||Standard Deviation|Mean
699264|NCT00001262|Primary|Gross Motor Development at 36 Mos of Age or at Death (Mos)|This was measured based on the Denver Developmental Screening Test (DDST) I or II for age-appropriate gross motor development in apparently normal healthy subjects at specific ages (in months). The DDST employs a grid to assess expected developmental milestones in relation to chronologic age.|36 months or death|||Other - months||Standard Deviation|Mean
699265|NCT00001304|Primary|Urine Calcium Excretion Level|Measurements were taken1 hour before the morning dose of PTH or, calcitriol and calcium; UOM = mmol/24 h, normal range 1.25-6.25. Measurements were obtained on three successive days (three separate measures) semiannually at the NIH CC for each protocol subject. The average data are the average of these three semi-annual data points for each subject which are then averaged across all the semi-annual means for all subjects within each arm over the three years of study.|3 years|All patients on the study||mmol/24 h||Standard Deviation|Mean
699266|NCT00001304|Secondary|Urinary Creatinine Clearance|Measurements were taken 1 hour before the morning dose of PTH or, calcitriol and calcium; UOM = ml/min, normal range 90-125. Measurements were obtained on three successive days (three separate measures) semiannually at the NIH CC for each protocol subject. The average data are the average of these three semi-annual data points for each subject which are then averaged across all the semi-annual means for all subjects within each arm over the three years of study.|3 years|All patients on the study||ml/min||Standard Deviation|Mean
699267|NCT00001304|Secondary|Serum Phosphorus Level|Measurements were taken 1 hour before the morning dose of PTH or, calcitriol and calcium; UOM = mmol/liter, normal range 0.7-1.4. Measurements were obtained on three successive days (three separate measures) semiannually at the NIH CC for each protocol subject. The average data are the average of these three semi-annual data points for each subject which are then averaged across all the semi-annual means for all subjects within each arm over the three years of study.|3 years|All patients on the study||mmol/liter||Standard Deviation|Mean
699268|NCT00001304|Secondary|Serum Magnesium Level|Measurements were taken 1 hour before the morning dose of PTH or, calcitriol and calcium; UOM = mmol/liter, normal range 0.65-1.05. Measurements were obtained on three successive days (three separate measures) semiannually at the NIH CC for each protocol subject. The average data are the average of these three semi-annual data points for each subject which are then averaged across all the semi-annual means for all subjects within each arm over the three years of study.|3 years|All patients on the study||mmol/liter||Standard Deviation|Mean
699282|NCT00002540|Primary|Prostate Cancer Death Rates|Prostate cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate. Rate is the number of deaths divided by person years of follow-up in the study.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years.|||Deaths per 10,000 PY|||Number
699269|NCT00001304|Primary|Serum Calcium Level|Measurements were taken 1 hour before the morning dose of PTH or, calcitriol and calcium; UOM = mmol/liter, normal range 2.05-2.5. Measurements were obtained on three successive days (three separate measures) semiannually at the NIH CC for each protocol subject. The average data are the average of these three semi-annual data points for each subject which are then averaged across all the semi-annual means for all subjects within each arm over the three years of study.|3 years|All patients on the study||mmol/liter||Standard Deviation|Mean
699270|NCT00001304|Secondary|Serum 25-hydroxyvitamin D Level|Measurements were taken 1 hour before the morning dose of PTH or, calcitriol and calcium; UOM = ng/ml. Measurements were obtained on three successive days (three separate measures) semiannually at the NIH CC for each protocol subject. The average data are the average of these three semi-annual data points for each subject which are then averaged across all the semi-annual means for all subjects within each arm over the three years of study.|3 years|All patients on the study||ng/ml||Standard Deviation|Mean
699271|NCT00001304|Secondary|Serum 1,25-hydroxyvitamin D Level|Measurements were taken 1 hour before the morning dose of PTH or, calcitriol and calcium; UOM = pg/ml. Measurements were obtained on three successive days (three separate measures) semiannually at the NIH CC for each protocol subject. The average data are the average of these three semi-annual data points for each subject which are then averaged across all the semi-annual means for all subjects within each arm over the three years of study.|3 years|All patients on the study||pg/ml||Standard Deviation|Mean
699272|NCT00001213|Primary|Number of Eyes With a Corneal Cystine Crystal Score (CCCS) Response|"Response is defined as a decrease from baseline of at least 1 in Corneal Cystine Crystal Score (CCCS) at any time on study when baseline CCCS is greater than or equal to 1, or CCCS does not increase at least 1 at any time on study when baseline CCCS is less than 1.
The CCCS is based on a library of slit-lamp photographs of corneas with increasing crystal densities (0-3). Slit-lamp photos were to be taken to assess the extent of the corneal crystal accumulation. To minimize bias when assessing the extent of corneal crystal accumulation, photos were centrally graded at the National Eye Institute (NEI) where each photo was graded independently by masked graders. If more than one CCCS was recorded in a given study year, the highest (worst) CCCS value was used for that year.
The results were obtained from a combined analyses of the NIH cysteamine studies evaluating various cysteamine ophthalmic solution formulations from 1986 through 2005."|Any Time Point Up to 19 Years|One hundred sixty-one (161) participants were analyzed in the pre-specified intent-to-treat population [defined as patients who received study medication (between 1986 and 2005), and had a baseline and a post-baseline CCCS value]. After 2005, all participants enrolled received open-label treatment and only safety data was obtained.||eyes|Participants||Number
699273|NCT00001213|Primary|Number of Participants With Serious and Non-Serious Adverse Events|Since efficacy of ophthalmic cysteamine was established and a New Drug Application (NDA) filed, the post-hoc primary outcome measure is the evaluation of safety information. There was no specified time frame for this outcome measure, as safety data was being collected until the drug became available for commercial purchase in May 2013.|Any Time Point up to 27 Years|||participants|||Number
699274|NCT00001832|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|10.5 months|||Participants|||Number
699275|NCT00001832|Primary|Clinical Response|Complete response (CR) is defined as the disappearance of all clinical evidence of disease. Partial response (PR) is a 50% or greater decrease in the sum of the products of perpendicular diameters of all measurable lesions for at least one month. No new lesions may appear, and none may increase. Minor response (MR) is a 25-49% decrease in the sum of the products of the perpendicular diameters of all measurable lesions. Appearance of new lesions following a PR or CR are considered relapses. Patients with progressive disease (PD) and no evidence of stable disease will be taken off study after receiving IL-2.|Every three to four weeks after the treatment, for up to 5 years.|||Participants|||Number
699276|NCT00002525|Secondary|5-year Disease-free Survival Rate in Patients With Dukes' B2 Disease|Disease-free survival (DFS) was defined as time from randomization to recurrence, second invasive primary cancer, or deaths, whichever occurred first. Patients who were still alive and had no DFS events were censored at the last disease assessment date known to be free of DFS events. Patients without any follow up data were censored at random assignment. Kaplan-Meier method was used to estimate the 5-year DFS rate.|every 3 months for 2 years, then every 6 months for 2 years, and then annually until year 15 after randomization|All randomized patients with Dukes' B2 disease who had complete disease assessment data||proportion of participants||95% Confidence Interval|Number
699277|NCT00002525|Secondary|5-year Overall Survival Rate in Patients With Dukes' B2 Disease|Overall survival (OS) is defined as time from randomization to death from any cause or last date known alive. Kaplan-Meier method was used to estimate 5-year OS rate|every 3 months for 2 years, then every 6 months for 2 years, and then annually until year 15 after randomization|All randomized patients with Dukes' B2 disease||proportion of participants||95% Confidence Interval|Number
699278|NCT00002525|Secondary|5-year Disease-free Survival Rate in Patients With Dukes' B3/C Disease|Disease-free survival (DFS) was defined as time from randomization to recurrence, second invasive primary cancer, or deaths, whichever occurred first. Patients who were still alive and had no DFS events were censored at the last disease assessment date known to be free of DFS events. Patients without any follow up data were censored at random assignment. Kaplan-Meier method was used to estimate the 5-year DFS rate.|every 3 months for 2 years, then every 6 months for 2 years, and then annually until year 15 after randomization|All randomized patients with Dukes' B3 and C disease who had complete disease assessment data||proportion of participants||95% Confidence Interval|Number
699279|NCT00002525|Primary|5-year Overall Survival Rate in Patients With Dukes' B3/C Disease|Overall survival (OS) is defined as time from randomization to death from any cause or last date known alive. Kaplan-Meier method was used to estimate 5-year OS rate|every 3 months for 2 years, then every 6 months for 2 years, and then annually until year 15 after randomization|All randomized patients with Dukes' B3 and C disease||proportion of participants||95% Confidence Interval|Number
699280|NCT00002540|Secondary|T5 PSA Screening Results|Prostate-Specific Antigen (PSA) result.|T5 (five years after entry)|All males in the Prostate Screening arm who had a PSA screen at T5 were analyzed.||Participants|||Number
699281|NCT00002540|Secondary|T4 PSA Screening Result|Prostate-Specific Antigen (PSA) result|T4 (four years after entry)|All males in the Prostate Screening arm who had a PSA screen at T4 were analyzed.||Participants|||Number
699291|NCT00002540|Secondary|Complications of Diagnostic Evaluation (DE) Following a Positive Screening Test|Number of positive screens with complications|One year from screening examination|The units analyzed were positive screening exams with documented diagnostic follow-up. If a participant received 3 positive screens with documented follow-up after each one, he would be counted 3 times in the number of units analyzed.||Positive screens w/ complications|Positive Screens with Follow-up||Number
699292|NCT00002540|Secondary|Prostate Cancer Incidence Rates|Prostate cancer diagnoses confirmed by medical record abstraction. Incidence rate (cumulative) defined as prostate cancer diagnoses divided by person years at risk for prostate cancer.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years.|All male participants randomized were analyzed. An intention-to-treat analysis was performed.||Diagnoses per 10,000 PY|||Number
699293|NCT00002540|Secondary|Prostate Cancer Incidence|Prostate cancer diagnoses confirmed by medical record abstraction. Incidence rate (cumulative) defined as prostate cancer diagnoses divided by person years at risk for prostate cancer.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years.|All male participants randomized were analyzed. An intention-to-treat analysis was performed.||Participants|||Number
699294|NCT00002540|Secondary|Death Rates From All Causes|Deaths from all causes were compared between the prostate cancer screening arm and the usual care arm. Rate is the number of deaths divided by person years of follow-up in the study.|Events through 13 years of follow-up or through December 31, 2009.|All male participants were analyzed. An intention-to-treat analysis was performed.||Deaths per 10,000 PY|||Number
699295|NCT00002540|Secondary|Deaths From All Causes|Deaths from all causes were compared between the prostate cancer screening arm and the usual care arm.|Events through 13 years of follow-up or through December 31, 2009.|All male participants were analyzed. An intention-to-treat analysis was performed.||Participants|||Number
699296|NCT00002540|Primary|Prostate Cancer Deaths|Prostate cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years.|All male participants randomized were analyzed. An intention-to-treat analysis was performed.||Participants|||Number
699297|NCT00002558|Primary|Overall Objective Response|Overall Objective Response will be assessed prior to dose-intensive therapy and at the completion of therapy. Complete disappearance of all clinical, radiographic and biochemical (normal AFP and HCG) evidence of disease for a minimum of 4 weeks (CR to chemotherapy). Patients must be free of disease for a minimum of 4 weeks. Partial Response: Complete disappearance of all biochemical evidence of disease in patients without a surgical procedure for a residual radiographic mass. Patients must demonstrate no biochemical recurrence or progression of radiographic masses for a minimum of four weeks (PR to chemotherapy}|2 years|||participants|||Number
699298|NCT00002597|Secondary|Positive Re-biopsy Rate at Two Years|The rate of prostate rebiopsy at two years is defined as the proportion of patients whose results are positive among all eligible patients who had a repeat biopsy at two years. The rate was estimated separately in each arm.|From registration to two years|All eligible patients who had a repeat biopsy at 2 years.||percentage of participants|||Number
699299|NCT00002597|Secondary|Disease-free Survival Rate (10 Years)|Disease-free failure is defined as documentation of progression (local progression, distant failure, and biochemical failure) or death from any cause. Disease-free survival rates were estimated by the Kaplan-Meier method.|From registration to 10 years|All eligible patients.||percentage of participants||95% Confidence Interval|Number
699300|NCT00002597|Secondary|Second Biochemical Relapse Rate (10 Years)|Second biochemical relapse is as defined as follows (after initiation of salvage hormone therapy): A rise in PSA on at least two consecutive cases above the nadir (after initiation of salvage hormone therapy), with the rises in PSA exceeding 1 ng/ml above the nadir; or failure to reach 4 ng/L or less at 18 months. The rates of second biochemical relapse were estimated by means of cumulative incidence functions.|From registration to 10 years|All eligible patients.||percentage of participants||95% Confidence Interval|Number
699301|NCT00002597|Secondary|Clinical Relapse Rate (10 Years)|Clinical relapse is defined as local progression or distant metastases. Failure rates were estimated by means of cumulative incidence functions.|From registration to 10 years|All eligible patients.||percentage of participants||95% Confidence Interval|Number
699302|NCT00002597|Secondary|Biochemical Failure Rate (10 Years)|The Phoenix definition of biochemical failure was used - an increase in the prostate-specific antigen (PSA) level of >2 ng per milliliter above the nadir. Failure rates were estimated by means of cumulative incidence functions.|From registration to 10 years|All eligible patients.||percentage of participants||95% Confidence Interval|Number
699303|NCT00002597|Secondary|Distant Failure Rate (10 Years)|Failure is defined as documented metastatic disease. Failure rates were estimated by means of cumulative incidence functions.|From registration to 10 years|All eligible patients.||percentage of participants||95% Confidence Interval|Number
699304|NCT00002597|Secondary|Local Progression Rate (10 Years)|Local progression defined as documented local progression as determined by clinical exam . Failure rates were estimated by means of cumulative incidence functions.|From registration to 10 years|All eligible patients.||percentage of participants||95% Confidence Interval|Number
699305|NCT00002597|Secondary|Disease-specific Survival Rate (10 Years)|Disease-specific failure is defined as death certified as due to prostate cancer (by central review), death due to complications of treatment (irrespective of malignancy status), death from unknown causes with active malignancy, or death from unknown causes with previously documented relapse (either clinical or biochemical). Survival rates were estimated by means of cumulative incidence functions.|From registration to 10 years|All eligible patients.||percentage of participants||95% Confidence Interval|Number
699306|NCT00002597|Primary|Overall Survival Rate (10-year)|Overall survival (OS) was calculated from randomization to the date of death from any cause and overall survival rates were estimated by the Kaplan–Meier method.|From date of randomization to 10 years|All eligible patients.||percentage of patients||95% Confidence Interval|Number
699307|NCT00002601|Secondary|5-year Overall Survival|Estimated using the product-limit method of Kaplan and Meier.|Until death from any cause, up to 5 years|||percentage of participants||95% Confidence Interval|Number
699335|NCT00002931|Primary|Progression-free Survival|Estimated using the product-limit method of Kaplan and Meier. Progression is defined as an increase o any radiologically measureable tumor by greater than 25% or a greater than 10% increase of elevated tumor markers.|Until disease progression, up to 5 years.|||Months||95% Confidence Interval|Mean
699308|NCT00002601|Secondary|5-year Progression-free Survival|Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 25% increase in the sum of the longest diameter of target lesions, or the appearance of new lesions.|Until disease progression, up to 5 Years|||percentage of participants||95% Confidence Interval|Number
699309|NCT00002601|Primary|Toxicities Counts|Number of patients with grade 3 and 4 toxicities observed during cycles 1 & 2 using the Common Toxicity Criteria Version for Chemotherapy.|2 months after completion of second cycle of treatment.|||Participants|||Count of Participants
699310|NCT00002601|Primary|Number of Participants With Grade 3 Bilirubin|Criteria for early termination of this feasibility study: > 2 patients experience grade 4 or 5 hematologic toxicity or more that 3 patients experience grade 3 hematologic toxicity; > 2 patients experience grade 3 hepatic or gastrointestinal toxicity or > 3 patients are unable to receive the second cycle of treatment; > 2 patients experience grade 5 toxicity related to treatment regimen.|2 years after completion of treatment|||participants with Grade 3 Bilirubin|||Number
699311|NCT00002651|Other Pre-specified|General Symptoms||15 months||||||
699312|NCT00002651|Other Pre-specified|Role Functioning|Mean of the change in role functioning from randomization|15 months||||||
699313|NCT00002651|Other Pre-specified|Social Functioning|Mean of the change in social functioning from randomization|15 months||||||
699314|NCT00002651|Other Pre-specified|Global Perception of Quality of Life||15 months||||||
699315|NCT00002651|Primary|Vitality|This outcome was scored on a scale of 0 to 100, with higher scores indicating better functioning. This analysis looks at mean change from Baseline score to 3 Months.|3 months|Only eligible patients with a usable form set for Vitality both at baseline and 3 months were included in this analysis.||units on a scale||Standard Error|Mean
699316|NCT00002651|Primary|High Libido|"This outcome was assessed by having patients report whether their interest in sexual activities was very high, high, or moderate (a score of 1) or low or very low (a score of 0). This outcome measure is reporting a change from baseline in the percentage of participants with High Libido at 3 months. High Libido is defined as very high, high or moderate interest in sexual activities."|3 months|Only eligible patients with a usable answers regarding libido both at baseline and 3 months were included in this analysis.||percentage of participants|||Number
699317|NCT00002651|Primary|Erectile Dysfunction|This outcome was assessed by having patients report whether they had erectile dysfunction (a score of 1) or no erectile dysfunction (a score of 0). This analysis looks at change from Baseline to 3 Months.|3 months|Only eligible patients with a usable answers regarding erectile dysfunction both at baseline and 3 months were included in this analysis.||percentage of participants|||Number
699318|NCT00002651|Primary|Emotional Functioning as Measured by the SF-36 Mental Health Inventory|This outcome was scored on a scale of 0 to 100, with higher scores indicating better functioning. Change from Baseline in SF-36 Score at 3 Months|3 months|Only eligible patients with a usable form set for SF-36 Mental Health Inventory both at baseline and 3 months were included in this analysis.||units on a scale||Standard Error|Mean
699319|NCT00002651|Primary|Physical Functioning as Measured by the SF-36|This outcome was scored on a scale of 0 to 100, with higher scores indicating better functioning. Change from Baseline in SF-36 Score at 3 Months|3 months|Only eligible patients with a usable form set for Physical Functioning portion of the SF-36 both at baseline and 3 months were included in this analysis.||units on a scale||Standard Error|Mean
699320|NCT00002651|Primary|Overall Survival|Non-inferiority test to determine if intermittent combined androgen deprivation (CAD) overall survival is not substantially worse than continuous CAD overall survival. Specifically, the trial is designed for a one-sided test of the hypothesis that the hazard ratio of intermittent CAD to continuous CAD is 1.2. The assumptions used to compute the trial size are an overall type I error rate of 0.05 and a type II error of 0.10 (power = 0.9).|Up to 15 years|||years||95% Confidence Interval|Median
699321|NCT00002766|Primary|Complete Remission (CR)|complete remission (CR) Disappearance of all clinical evidence of leukemia for a minimum of four weeks. The patient should have a neutrophil count > 1,000 x 10^6/1, a platelet count > 100,000 x 10^9/1, no circulating blasts, and < than or = to blasts on bone marrow differential in a qualitatively normal or hypercellular marrow. Progressive disease or failure: Increasing bone marrow infiltrate or development of organ failure or extramedullary infiltrates due to leukemia.|2 years|||participants|||Number
699322|NCT00002842|Primary|2 Year Disease-free Survival .|Estimated using the product-limit method of Kaplan and Meier. Disease free survival, defined as first documented evidence of treatment failure. Acceptable evidence includes: Anastomotic - positive cytology or biopsy; Abdominal, pelvic and retroperitoneal nodes - progressively enlarging node as evidenced by 2 CT scans separated by at least a 4 week interval, ureteral obstruction in the presence of a mass as documented on CT scan; Peritoneum - positive cytology or biopsy, progressively enlarged intraperitoneal solid mass as evidenced by 2 CT scans separated by at least 4 weeks; Ascites - positive cytology or biopsy; Liver - positive cytology or biopsy; Pelvic mass - positive cytology or biopsy, progressively enlarging intrapelvic solid mass as evidenced by 2 CT scans separated by at least 4 weeks; Abdominal wall - positive cytology or biopsy; Lung - positive cytology or biopsy or presence of multiple pulmonary nodules; Bone marrow - positive cytology, aspiration or biopsy.|2 years after treatment|||percentage of participants||95% Confidence Interval|Number
699323|NCT00002850|Primary|Proportion of Patients Experiencing a Serious Bacterial Infection|This study evaluated the impact of prophylactic antibiotics on the incidence of serious bacterial infections (SBIs) during the first 2 months of treatment in patients with newly diagnosed multiple myeloma. Patients with multiple myeloma receiving initial chemotherapy were randomized on a 1:1:1 basis to daily ciprofloxacin, trimethoprim-sulfamethoxazole, or observation and evaluated for SBI for the first 2 months of treatment.|First three months of chemotherapy|||percentage of participants||95% Confidence Interval|Number
699336|NCT00002975|Primary|Response Rate||One Year|PI died, leaving incomplete data. Data not analyzed.|||||
699353|NCT00003389|Secondary|5-year Overall Survival|Overall survival is defined as the time from randomization to death or last known alive. The 5-year survival rate is the probability a patient survives 5 years.|Assessed every 2 months if patient is < 1 year from study entry, every 3 months for the second year, every 4 months for the third year, every 6 months for years 4 and 5, and yearly for 5 years|Eligible patients||Proportion of patients||95% Confidence Interval|Number
699324|NCT00002874|Secondary|Grade 3+ Toxicity|"Adverse events are graded using the Cooperative Group Common Toxicity Criteria and the Radiation Therapy Oncology Group (RTOG) Radiation Morbidity Scoring. Grade refers to severity, assigning Grades 1 through 5 based on this general guideline: Grade 0 None, Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related toxicity. Toxicities reported to have occurred within 90 days from the start of radiotherapy are reported as Acute Radiotherapy, all later toxicities are reported as Hormone therapy and late radiotherapy toxicity. The highest grade toxicity event per subject is counted within each of these time periods. Four-year follow-up was required of all patients; patients are followed until death."|From date of randomization to four years.|Eligible patients who started protocol treatment and did not withdraw consent.||participants|||Number
699325|NCT00002874|Secondary|Progression-free Survival (12-year Rates Reported)|"Progress-free survival rates were estimated by the Kaplan-Meier method, with failure defined as the first occurrence of PSA failure, local, regional or distant failure, or death from any cause. Patients alive without progression at time of analysis were censored. Four-year follow-up was required of all patients, but twelve-year rates were reported. Patients are followed until death. Progression-free Survival is more accurate wording for the protocol endpoint of Freedom from Progression, and matches the protocol definition."|From date of randomization to 12 years.|Eligible patients who did not withdraw consent.||percentage of participants||95% Confidence Interval|Number
699326|NCT00002874|Secondary|Prostate Cancer Death (12-year Rates Reported)|"Prostate cancer death rates were estimated by the cumulative incidence method, with failure defined as death due to prostate cancer or complications of protocol treatment (centrally reviewed), death with known progressive metastatic disease while on salvage hormone therapy, or death with a known rising PSA while on salvage hormone therapy. Patients alive at time of analysis were censored. Any other death was treated as a competing risk. Four-year follow-up was required of all patients, but twelve-year rates were reported. Patients are followed until death. Prostate cancer death is a more accurate wording for the protocol endpoint of disease-specific survival, and matches the protocol definition."|From date of randomization to 12 years.|Eligible patients who did not withdraw consent.||percentage of participants||95% Confidence Interval|Number
699327|NCT00002874|Secondary|Distant Failure (12-year Rates Reported)|Distant failure rates were estimated by the cumulative incidence method, with failure defined as the first occurrence of distant failure. Patients alive without distant metastases at time of analysis were censored. Death without distant metastasis was treated as a competing risk. Four-year follow-up was required of all patients, but twelve-year rates were reported. Patients are followed until death.|From date of randomization to 12 years.|Eligible patients who did not withdraw consent.||percentage of participants||95% Confidence Interval|Number
699328|NCT00002874|Secondary|PSA Complete Response at End of Protocol Treatment|Complete response is defined as a drop in PSA on protocol treatment to less than 0.2 ng/ml. Note that when the study opened many institutions could not detect PSA < 05 ng/ml.|End of protocol treatment, which is planned to last for two years|Eligible patients who did not withdraw consent.||Participants|||Count of Participants
699329|NCT00002874|Secondary|Third PSA Recurrence (12-year Rates Reported)|Third PSA recurrence rates (i.e. second PSA failure on study) were estimated by the cumulative incidence method, with failure defined as PSA value of 0.5ng/ml or higher or any disease progression after starting salvage hormone therapy. Patients alive without third PSA recurrence at time of analysis were censored. Death without third PSA recurrence was treated as a competing risk. Four-year follow-up was required of all patients, but twelve-year rates were reported. Patients are followed until death.|From start of salvage hormone therapy to 12 years.|Eligible patients who did not withdraw consent and who started salvage hormone therapy.||percentage of participants||95% Confidence Interval|Number
699330|NCT00002874|Secondary|Second PSA Recurrence (12-year Rates Reported)|Second PSA recurrence (SPSAR) rates (i.e. first PSA failure on study) were estimated by the cumulative incidence method, with failure defined as the first occurrence of one of the following events: 1. Increase in PSA following protocol treatment according to the following criteria met during protocol treatment: If PSA dropped to undetectable level (<0.2 ng/ml) during protocol treatment (PT) then failure = increase after PT to >= 0.5 ng/ml ; If PSA decreased to a detectable level (≥ 0.2 ng/ml) during PT, then failure = increase PT of >= 0.3 ng/ml above the lowest detectable level; If PSA did not decrease during PT then failure = increase in PSA after PT of >= 0.5 ng/ml above entry PSA level. 2. The start of salvage hormone therapy. Patients alive without SPSAR at time of analysis were censored. Death without SPSAR was treated as a competing risk. Four-year follow-up was required of all patients, but twelve-year rates were reported. Patients are followed until death.|From date of randomization to 12 years.|Eligible patients who did not withdraw consent.||percentage of participants||95% Confidence Interval|Number
699331|NCT00002874|Secondary|Non-Prostate Cancer Death (12-year Rates Reported)|"Non-prostate cancer death rates were estimated by the cumulative incidence method, with failure defined as any death that does not fall into the following categories: death due to prostate cancer or complications of protocol treatment (centrally reviewed), death with known progressive metastatic disease while on salvage hormone therapy, or death with a known rising PSA while on salvage hormone therapy. All other deaths are considered competing risks. Patients alive at time of analysis were censored. Any other death was treated as a competing risk. Four-year follow-up was required of all patients, but twelve-year rates were reported.
Patients are followed until death. Non-Prostate cancer death is a more accurate wording for the protocol endpoint of non-disease-specific survival, and matches the protocol definition."|From date of randomization to 12 years.|Eligible patients who did not withdraw consent.||percentage of participants||95% Confidence Interval|Number
699332|NCT00002874|Primary|Overall Survival (12-year Rates Reported)|"Overall survival rates were estimated by the Kaplan-Meier method, with failure defined as death by any cause. Four-year follow-up was required of all patients, twelve-year rates are reported. Four-year follow-up was required of all patients, but twelve-year rates were reported.
Patients are followed until death."|From date of randomization to 12 years.|Eligible patients who did not withdraw consent.||percentage of participants||95% Confidence Interval|Number
699333|NCT00002931|Secondary|Overall Survival|Estimated using the product-limit method of Kaplan and Meier.|Until death from any cause, up to 5 years.|||Months||95% Confidence Interval|Median
699334|NCT00002931|Primary|Toxic Effects|Number of Participants with Grade 3 and 4 Adverse Events Related to Protocol-based Therapy|From date of randomization until death of any cause, assessed up to 12 weeks|||participants|||Number
699337|NCT00003138|Secondary|Quality of Life- Total Functional Assessment of Cancer Therapy - General (FACT-G) Score at 4 Months|The FACT-G scale has 4 dimensions, including physical well-being, social/family well-being, emotional well-being, and functional well-being. The score for each subscale was added together to obtain the total FACT-G score that was evaluated on this study. The total FACT-G score ranges from 0 to 108 with higher scores reflecting better quality of life. It was administered at the time of study entry, every 4 months for the first year, and at the time patient went off treatment. Due to limited data after 4 months on treatment, the analysis was restricted to the four-month time point.|Assessed at 4 months|Only patients who completed quality of life assessment at 4 months were included in this analysis.||Scores on a scale||Standard Deviation|Mean
699338|NCT00003138|Secondary|Overall Survival|Time from randomization to death from any cause. Patients alive at the time of analysis were censored at the date of last contact.|Assessed every 3 months for 2 years, every 6 months for 3 subsequent years, and annually thereafter|All patients with complete data were included in this analysis.||Months||95% Confidence Interval|Median
699339|NCT00003138|Primary|Proportion of Patients Free of Transfusion at 4 Months|Whether a patient required transfusion or not at 4 months was recorded.|Assessed at 4 months|Only patients with transfusion data were included in this analysis.||Proportion of patients||95% Confidence Interval|Number
699340|NCT00003199|Secondary|Number of Participants With Toxicity of a Combination of Low-dose IL-2 and GM-CSF|IL-2/GM-CSF toxicity assessed using the NCI Toxicity Criteria. Toxicity was defined as any grade 2, 3, 4 or 5 CNS (except grade 0-3 malaise and fatigue) toxicity; any grade 3, 4, or 5 non-CNS or non-hematological toxicity (except grade 0-3 bilirubin); or any grade 4 or 5 hematological toxicity.|16 Weeks|28 (56%) of 50 patients started IL-2/GM-CSF immunotherapy. Stopping rules were not met for this study.||Participants|||Count of Participants
699341|NCT00003199|Secondary|Overall Survival|Overall survival of patients treated for inflammatory (Stage IIIb) and responsive stage IV breast cancer with BUMELTT and PBSC support and low dose immunotherapy with IL2 and GM-CSF.|11 years|||Participants|||Count of Participants
699342|NCT00003199|Primary|Event-free Survival|Event-free survival of patients treated for inflammatory (Stage IIIb) and responsive stage IV breast cancer with BUMELTT and PBSC support and low dose immunotherapy with IL2 and GM-CSF.|11 years|Study-wide, 20 patients out of 50 have event-free survival.||Participants|||Count of Participants
699343|NCT00003222|Primary|Measure of Tumor-antigen-specific Immunity in Sentinel Immunized Node (SIN) by Elispot Assay||Weeks 0-6,12; Months 6,12 and 24|Analysis of this outcome measure was performed on subjects in Stage I of the trial. Sentinel immunized nodes (SIN) were not evaluable for early tumor progression (5 arm 1, 2 arm 2) and patient refusal (1 arm 2). Thus, SINs were evaluable from 8 in arm 1 and 10 on arm 2, exceeding the protocol requirement for at least 6 subjects on each arm.||responders|||Number
699344|NCT00003222|Primary|Measure of Tumor-antigen-specific Immunity in Peripheral Blood Mononuclear Cells (PBMC) by Elispot Assay||Weeks 0-6,12; Months 6,12 and 24|The analysis of this outcome measure was performed on subjects enrolled in Stage I of the trial, which included 13 subjects in each arm. Some patients were not evaluable because of inadequate sample availability.||responders|||Number
699345|NCT00003222|Primary|Evaluation of Objective Clinical Response (CR/PR/SD)|The primary end point for this trial was clinical response. This was assessed by measurement of assessable metastatic deposits by CT, MRI, or direct measure of cutaneous deposits. Baseline tumor measurements used for assessment of clinical response were those obtained most immediately before the first vaccine administration and within 6 weeks of protocol entry. Measurements were made and reviewed by a multidisciplinary team. The original protocol defined tumor response on the basis of changes in cross-sectional area calculated as the product of two perpendicular measures. However, since the initiation of this study, the Response Evaluation Criteria in Solid Tumors Group (RECIST) system was employed as the current standard for clinical trials, in which response is based on changes in maximum cross-sectional dimensions. Computed tomography scans of clinical responders were reviewed again by a senior faculty radiologist not otherwise involved in the study.|Weeks 0-6,12; Months 6,12 and 24|The analysis of this outcome measure was performed on subjects enrolled in Stage I of the trial, which included 13 subjects in each arm.||participants|||Number
699346|NCT00003224|Other Pre-specified|Number of Participants With a Proliferative Response to Tetanus Helper Peptide|Proliferative response measured in participants using a tritiated thymidine incorporation assay with peripheral blood mononuclear cells (PBMC) stimulated with the tetanus peptide in vitro, and measured at 5 days after in vitro culture.|during vaccination|All evaluable enrolled patients were assayed.||participants|||Number
699347|NCT00003224|Secondary|Immunogenicity of Each Vaccine Regimen|T cell responses to the p946 (gp100 [280-288]) peptide. All enrolled patients were assayed for immune response to the gp100 peptide by ELIspot assay after 14 days in vitro sensitization. The number with a response in each study arm is reported.|up to 12 months since enrollment|||participants|||Number
699348|NCT00003224|Primary|Safety: Grade 3 Adverse Events|Adverse events are monitored according to NCI/DCT Common Toxicity Criteria|Up to 24 months after last vaccine|||participants|||Number
699349|NCT00003377|Secondary|Overall Survival at 2 Years|Product-limit estimate of the probability of being alive at 24 months based on those 20 patients who were treated at the study recommended dose-level is 0.80, 95 % confidence interval (0.62-0.97)|2 years|||probability||95% Confidence Interval|Mean
699350|NCT00003377|Secondary|Disease-free Survival at 2 Years|"Product-limit estimate of the probability of being alive and progression-free at 24 months based on those 20 patients who were treated at the study recommended dose level (RDL) is 0.65, 95% confidence interval (0.44-0.86).
Progression is defined as a 50% or greater increase in the product from any lesion documented within eight weeks for study entry or the appearance of any new lesion within eight weeks of entry into study."|2 years|||probability||95% Confidence Interval|Mean
699351|NCT00003377|Primary|Dose Limiting Toxicity(DLT)/Significant Dose Delay of Paclitaxel With Cisplatin as Assessed by CTC 2.0 After 6 Cycles of Treatment||up to 21 weeks|||participants|||Number
699352|NCT00003389|Secondary|Incidence of Second Cancers|Number of patients who developed second primary cancers|Assessed every 2 months if patient is < 1 year from study entry, every 3 months for the second year, every 4 months for the third year, every 6 months for years 4 and 5, and yearly for 5 years|||participants|||Number
699444|NCT00004978|Secondary|Plasma HIV RNA Levels|log10 HIV-RNA averaged throughout follow-up|From randomization through study end - median of 7.6 years follow-up|HIV-RNA measurement averaged over followup visits for all participants with at least one follow-up measurement.||log10 HIV-RNA||Standard Deviation|Mean
699354|NCT00003389|Primary|Failure-free Survival at 5 Years|"Failure-free survival is defined as the time from randomization to the earlier of progression/relapse or death. The 5-year failure-free survival is the probability a patient is failure-free and survives 5 years.
Progression is defined as an increase in size of 25% of the sum of the products of the pretreatment measurements or appearance of new lesions. Significant enlargement of the liver or spleen is evidence of progression. A significant increase in size is defined as > 2.0 cm in distance between costal margin and the inferior margin of either organ.
Relapse is defined as the re-appearance of any clinical evidence of Hodgkin's disease in a patient who has had a complete response. Relapse for partial responders is defined as progressive disease relative to disease status during the partial remission."|Assessed every 2 months if patient is < 1 year from study entry, every 3 months for the second year, every 4 months for the third year, every 6 months for years 4 and 5|Eligible patients||Proportion of patients||95% Confidence Interval|Number
699355|NCT00003457|Secondary|Percentage of Participants Who Survived|6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival|6 months, 12 months, 24 months, 36 months, 48 months, 60 months|All study subjects receiving any Antineoplaston therapy||Percentage of participants|||Number
699356|NCT00003457|Primary|Number of Participants With Objective Response|Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks; Stable Disease (SD), < 50% decrease and < 25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least 8 weeks; Progressive Disease (PD), >=25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions compared to the lowest sum recorded.|12 months|||Participants|||Number
699357|NCT00003458|Secondary|Percentage of Participants Who Survived|6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival|6 months, 12 months, 24 months, 36 months, 48 months, 60 months|All study subjects receiving any Antineoplaston therapy||Percentage of participants|||Number
699358|NCT00003458|Primary|Number of Participants With Objective Response|Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks.|12 months|||Participants|||Number
699359|NCT00003459|Secondary|Percentage of Participants Who Survived|6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival|6 months, 12 months, 24 months, 36 months, 48 months, 60 months|All study subjects receiving any Antineoplaston therapy||Percentage of participants|||Number
699360|NCT00003459|Primary|Number of Participants With Objective Response|Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks.|12 months|||Participants|||Number
699361|NCT00003460|Secondary|Percentage of Participants Who Survived|6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival|6 months, 12 months, 24 months, 36 months, 48 months, 60 months|All study subjects receiving any Antineoplaston therapy||Percentage of participants|||Number
699362|NCT00003460|Primary|Number of Participants With Objective Response|Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks.|12 months|||Participants|||Number
699363|NCT00003468|Secondary|Percentage of Participants Who Survived|6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival|6 months, 12 months, 24 months, 36 months, 48 months, 60 months|All study subjects receiving any Antineoplaston therapy||Percentage of participants|||Number
699364|NCT00003468|Primary|Number of Participants With Objective Response|Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks..|12 months|||Participants|||Number
699365|NCT00003469|Secondary|Percentage of Participants Who Survived|6 months, 12 months, 24 months overall survival|6 months, 12 months, 24 months|All study subjects receiving any Antineoplaston therapy||Percentage of participants|||Number
699366|NCT00003469|Primary|Number of Participants With Objective Response|Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks.|12 months|||Participants|||Number
699367|NCT00003470|Secondary|Percentage of Participants Who Survived|6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival|6 months, 12 months, 24 months, 36 months, 48 months, 60 months|All study subjects receiving any Antineoplaston therapy||Percentage of participants|||Number
699368|NCT00003470|Primary|Number of Participants With Objective Response|Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks; Stable Disease (SD), <50% decrease and <25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least eight weeks; Progressive Disease (PD), >=25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions.|12 months|||Participants|||Number
699369|NCT00003473|Secondary|Percentage of Participants Who Survived|6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival|6 months, 12 months, 24 months, 36 months, 48 months, 60 months|All study subjects receiving any Antineoplaston therapy||Percentage of participants|||Number
699370|NCT00003473|Primary|Number of Participants With Objective Response|Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks.|12 months|||Participants|||Number
699371|NCT00003475|Secondary|Percentage of Participants Who Survived|6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival|6 months, 12 months, 24 months, 36 months, 48 months, 60 months|All study subjects receiving any Antineoplaston therapy||Percentage of participants|||Number
699372|NCT00003475|Primary|Number of Participants With Objective Response|Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks.|12 months|||Participants|||Number
699373|NCT00003476|Secondary|Percentage of Participants Who Survived|Six months and Twelve months overall survival|6 months, 12 months|All study subjects receiving any Antineoplaston therapy||Percentage of participants|||Number
699374|NCT00003476|Primary|Number of Participants With Objective Response|Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks; Stable Disease (SD), <50% decrease and <25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least eight weeks; Progressive Disease (PD), >=25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions.|12 months|||Participants|||Number
699375|NCT00003477|Secondary|Percentage of Participants Who Survived|6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival|6 months, 12 months, 24 months, 36 months, 48 months, 60 months|All study subjects receiving any Antineoplaston therapy||Percentage of participants|||Number
699376|NCT00003477|Primary|Number of Participants With Objective Response|Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks. Stable Disease (SD): <50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions and no Progressive Disease, sustained for at least four weeks. Progressive Disease (PD): >=25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions.|12 months|||Participants|||Number
699377|NCT00003479|Secondary|Percentage of Participants Who Survived|6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival|6 months, 12 months, 24 months, 36 months, 48 months, 60 months|All study subjects receiving any Antineoplaston therapy||Percentage of Participants|||Number
699378|NCT00003479|Primary|Number of Participants With Objective Response|Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks; Stable Disease (SD), <50% decrease and <25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least eight weeks; Progressive Disease (PD), >=25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions.|12 months|||Participants|||Number
699379|NCT00003483|Secondary|Percentage of Participants Who Survived|6 months, 12 months, 24 months overall survival|6 months, 12 months, 24 months|All study subjects receiving any Antineoplaston therapy||Percentage of Participants|||Number
699380|NCT00003483|Primary|Number of Participants With Objective Response|Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks; Stable Disease (SD), <50% decrease and <25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least eight weeks; Progressive Disease (PD), >=25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions.|12 months|||Participants|||Number
699381|NCT00003537|Secondary|Percentage of Participants Who Survived|6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival|6 months, 12 months, 24 months, 36 months, 48 months, 60 months|All study subjects receiving any Antineoplaston therapy||Percentage of participants|||Number
699382|NCT00003537|Primary|Number of Participants With Objective Response|Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks; Stable Disease (SD), <50% decrease and <25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least eight weeks; Progressive Disease (PD), >=25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions.|12 months|||Participants|||Number
699383|NCT00003590|Secondary|Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by CTC 2.0 terminology. For each patient, worst grade of each event type is reported. Grade 3 - Severe, Grade 4 - Life-threatening, Grade 5 - Fatal|Patients were assessed for adverse events 4 weeks after starting treatment. Assessments for adverse events continued every 3 months for the duration of protocol therapy. On average patients remained on therapy for 8 months|Eligible patients who had received any hydroxyurea were included in the adverse event summaries. Any CTC 2.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.||Participants with a given type of AE|||Number
699384|NCT00003590|Primary|Assess Number of Patients Who Achieve Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR)|Complete Response (CR)is a complete disappearance of all measurable and evaluable disease. No new lesions, no disease related symptoms, no evidence of non-evaluable disease. Partial Response (PR)is greater than or equal to 50% decrease under baseline in sum of the products of perpendicular diameters of all measurable lesions. No progression of evaluable disease, no new lesions. Confirmation of CR or PR means a repeat scan at least 3 weeks apart documented before progression. No response means that patient did not achieve complete or partial response (either confirmed or unconfirmed).|Patients treated for 2 years or progression. If responding can continue at physician's discretion.|All eligible patients who started treatment were included in assessing response estimates.||Participants|||Number
699388|NCT00003726|Primary|Dose, Safety and Antitumor Response Rate of Administering Recombinant Desulfato Hirudin, Elpirudin to Previously Treated Patients With Extensive or Recurrent Small Cell Lung Cancer|Evaluated through clinical exams, tumor assessments, laboratory assessment, and adverse event assessments.|18 months|No data were collected|||||
699389|NCT00003782|Secondary|Amenorrhea in Premenopausal Women||baseline, 9 weeks, and 6, 12, 18, and 24 months||||||
699390|NCT00003782|Secondary|Quality of Life Among Breast Cancer Patients||baseline, 9 weeks, and 6, 12, 18, and 24 months||||||
699391|NCT00003782|Secondary|Toxicities Among the 3 Regimens||9 years||||||
699392|NCT00003782|Primary|Disease Free Survival||time to event: breast cancer recurrence; second primary cancer; death from any cause as a first event||||||
699393|NCT00003782|Primary|Overall Survival||8 years|||percentage of patients alive|||Number
699394|NCT00003820|Secondary|Overall Response Rate (ORR)|"Overall response as assessed as Complete Response (CR) + Partial Response (PR)
CR was determined as complete metabolic response (CMR), meaning complete resolution of 18-fluorodeoxyglucose (FDG) uptake within the tumor volume so that it is indistinguishable from surrounding normal tissue.
PR was determined as partial metabolic response (PMR), meaning reduction of greater than 25% in the standardized uptake value (SUV) adjusted for body surface area (SUV-BSA). A reduction in the extent of tumor FDG uptake is not required for PMR."|4 weeks|This was a single-arm study with multiple treatment periods added by amendment (ie, Secondary Group), with results reported by treatment period. As this was always considered a single-arm study, there was no intent to report the results for the initial treatment period separately as the Initial Group vs the Secondary Group.||percentage of participants|||Number
699395|NCT00003820|Secondary|Overall Survival (OS)|OS, assessed as the number of patients 5 years after treatment who are alive|5 years|This was a single-arm study with multiple treatment periods added by amendment (ie, Secondary Group), with results reported by treatment period. As this was always considered a single-arm study, there was no intent to report the results for the initial treatment period separately as the Initial Group vs the Secondary Group.||participants|||Number
699396|NCT00003820|Primary|Progression-free Survival (PFS)|PFS, assessed as the number of patients 5 years after treatment who are alive and without a ≥ 50% increase from nadir in the sum of the product of the greatest lesion diameters (SPD) of any previously-identified abnormal node, or appearance of any new lesion|5 years|This was a single-arm study with multiple treatment periods added by amendment (ie, Secondary Group), with results reported by treatment period. As this was always considered a single-arm study, there was no intent to report the results for the initial treatment period separately as the Initial Group vs the Secondary Group.||participants|||Number
699397|NCT00003298|Secondary|Progression Free Survival|Progression-free survival (PFS) was defined as time from registration until progression, recurrence, or death, whichever occurred first. If date of death occurred beyond three months from the date of last disease assessment, then PFS was censored at date of last disease assessment. Patients who were alive and progression-free were censored at the date of last disease evaluation.|assessed every month for the first 3 months, every 3 months for the next 21 months, every 6 months for the next year, and annually thereafter up to year 10|eligible and treated patients on step 1||years||90% Confidence Interval|Median
699398|NCT00003298|Secondary|Overall Survival|Overall survival was defined as the time from registration to death, where a subject was censored on date of last record alive.|assessed every month for the first 3 months, every 3 months for the next 21 months, every 6 months for the next year, and annually thereafter up to year 10|eligible and treated patients on step 1||years||90% Confidence Interval|Median
699399|NCT00003298|Primary|Grade 3 or Higher Toxicity Incidence on Step 1|Incidence is defined as proportion of patients with any grade 3 or higher treatment-related toxicities among all treated patients.|assessed at the end of every cycle (cycle=21 days) during treatment (3 cycles in total)|eligible and treated patients on step 1||percentage of participants||95% Confidence Interval|Number
699427|NCT00003641|Secondary|5-year Overall Survival Rate|Overall survival (OS) was defined as time from randomization to death from any cause. Patients still alive were censored at last known alive date. Kaplan-Meier method was used to estimate 5-year OS rate in the ITT patients.|assessed every 3 months for 2 years, every 6 months for 3 years|all randomized patients||proportion of participants||95% Confidence Interval|Number
699400|NCT00003298|Secondary|Best Confirmed Response to Neoadjuvant Therapy|Response was based on pathology at surgery. A patient achieved complete response if no gross or microscopic tumor were identified with the surgical specimen and nodal tissue. Stable response was defined as a response that did not qualify as complete response or progressive disease (PD), where PD indicated metastatic spread. Best confirmed response rate was defined as the proportion of patients with complete response (CR). A patient was considered unevaluable if the patient did not have surgery, the pathologist did not examine at least 15 lymph nodes, or the pathology report was unavailable.|Assessed at surgery time (surgery performed during week 8-10 after registration to the study)|Eligible and treated patients on step 1. Since no patient had a complete response in the study, one-sided 95% confidence interval was provided here.||percentage of participants||95% Confidence Interval|Number
699401|NCT00003869|Secondary|Number of Patients With a Confirmed Tumor Responses Treated With CAI.|"Confirmed response was defined as a complete response (CR) or partial response (PR) for patients with measurable disease or as a CR or regression (REGR) for patients with evaluable disease noted on 2 consecutive evaluations at least 4 weeks apart.
CR: total disappearance of all tumor;
PR: >=50% reduction of the sum of the products of the two greatest perpendicular diameters of all indicator lesions;
REGR: Definite decrease in tumor size and no new lesion(s)."|During Treatment (up to 5 years)|This data was not (and will never be) analyzed as it was not submitted consistently due to the trial design. (Patients were required to be SD or better to be randomized to carboxyamidotriazole or placebo.)|||||
699402|NCT00003869|Secondary|Clinically Significant (10-point) Decrease in Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) Quality of Life (QOL)Assessment From Baseline to Week 8|The FACT-L is a 36-item Likert instrument that combines frequency of symptomatic/QOL problems with perceived relative importance of each issue. It includes 4 constructs of well being: physical, social/family, emotional and functional, and a fifth construct, additional concerns, dealing solely with tumor related symptoms. Questionnaires were completed at baseline and 8 weeks. Questions within each construct were summated to obtain a construct score. A higher score relates to higher quality of life. A 10 point or greater decline (from baseline to week 8) was considered clinically significant.|Baseline to week 8|Participants who completed the baseline and week 8 FACT-L assessment are included in the analysis.||participants|||Number
699403|NCT00003869|Secondary|Clinically Significant (10-point) Decrease in UNISCALE Quality of Life (QOL)Assessment From Baseline to Week 8|The UNISCALE was used to assess QOL. UNISCALE is a single item global measure of QOL. Participant were to complete the questionnaire at baseline and every 8 weeks, prior to assessment by the treating physician. A high score indicates a higher quality of life while a low score represents a lower quality of life. A 10 point or greater decline (from baseline to week 8) in UNISCALE QOL score was considered clinically significant.|Baseline to week 8|Participants who completed the baseline and week 8 UNISCALE assessment are included in the analysis.||participants|||Number
699404|NCT00003869|Secondary|Time to Disease Progression (TTP)|"TTP is defined as the time from randomization to first documented disease progression(PD). Patients who were lost to follow-up were censored at the time of last evaluation. For patients who died without clear documentation, PD was assumed at the midpoint of the time interval between last evaluation and death. Median TTP was estimated using the Kaplan Meier method.
Measurable PD: ≥25% increase in the sum of the products of two greatest perpendicular diameters of all indicator lesions or appearance of new lesion(s). Evaluable PD: definite increase in tumor size or appearance of new lesion(s)"|up to 5 years|TTP was analyzed on all randomized patients on an intent to treat basis.||Months||95% Confidence Interval|Median
699405|NCT00003869|Secondary|Participants With Severe Non-hematologic Adverse Events|Severe non-hematologic adverse events were defined as adverse events grade 3 or higher, regardless of attribution to study drug. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC version 2.0)|every cycle during treatment|All treated participants; all participants who received study treatment.||Participants|||Number
699406|NCT00003869|Primary|Overall Survival (OS)|OS was defined as the time from randomization to death of any cause. Participants who did not die or were lost to follow-up were censored at the time of last evaluation/follow-up date. Patients were followed for a maximum of 5 years from randomization. The median OS with 95%CI was estimated using the Kaplan Meier method.|up to 5 years|Overall survival was analyzed on all randomized participants on an intent to treat basis.||Months||95% Confidence Interval|Median
699407|NCT00003875|Secondary|Proportion of Patients Who Relapsed Associated With the Regimen||From date of transplant to date of death from any cause, assessed up to 178 months|||Participants|||Count of Participants
699408|NCT00003875|Primary|Toxicity Associated With Aldesleukin Treatment After Stem Cell Rescue|Toxicity during IL-2 therapy of any of the following per NCI Common Toxicity version 3: grade 2, 3, 4, or 5 CNS (except grade 0-3 malaise, fatigue, anxiety and depression) toxicity; grade 3, 4, or 5 non-CNS or non-hematologic toxicity; any grade 4 or 5 hematologic toxicity.|IL-2 administration to one month after completion of IL-2 treatment|29 patients underwent autologous transplant and 21 of these patients after transplant went on to get IL-2 treatment . Toxicity for IL-2 therapy thus was only analyzed in these later 21 patients.||Participants|||Count of Participants
699409|NCT00003875|Primary|Toxicity Associated With High-dose Busulfan and Etoposide Followed by Stem Cell Rescue|Toxicity is defined as any grade 3 or grade 4 toxicity per the Bearman toxicity grading criteria following Busulfan and Etoposide high-dose chemotherapy, stem cell transplant, and the inability to recover sufficiently by day 100 to start IL-2 therapy.|Day -7 of transplant to 100 days post transplant|||Participants|||Count of Participants
699410|NCT00003875|Primary|Overall Survival of Patients on Busulfan and Etoposide Followed by Stem Cell Rescue and Aldesleukin|Estimated by the method of Kaplan and Meier.|From date of transplant to date of death from any cause, assessed up to 178 months|||Participants|||Count of Participants
699428|NCT00003641|Primary|5-year Relapse-free Survival Rate|Relapse-free survival (RFS) was defined as time from randomization to disease relapse or death from any cause, whichever occurred first. Patients without disease relapse were censored at last disease assessment date known of free of relapse. Kaplan-Meier method was used to estimate 5-year RFS rate in the intent-to-treat (ITT) patients.|assessed every 3 months for 2 years, every 6 months for 3 years|all randomized patients||proportion of participants||95% Confidence Interval|Number
699429|NCT00004412|Secondary|% Ulcers Which Completely Healed in Each Group, After 3 Months|Control Arm: given option to crossover to Treatment Arm if, ulcers have not closed after 12 weeks standard local care alone.|two additional courses of 8 week cycles|Per Protocol||percentage of completely healed ulcers|Participants||Number
699411|NCT00003895|Primary|T Cell Immunity to gp100 Peptide and to E7 12-20 Papilloma Virus Peptide|"Frequency measures obtained from each assay will be transformed to (common) logs for purposes of analysis. Repeated measures analyses will be performed on longitudinal data to assess patients’ immune response profiles over time. Comparability of assay methods will be assessed with correlation analyses, regression analyses, standard parametric and nonparametric tests, and agreement methods.
Pre- and post-immunization T-cell immunity to g209–2M peptide, to HPV16E7 peptide, and to a negative control HLA-A2 HIV peptide (pol) were assessed using HLA-A2/peptide tetramer-specific binding analysis. Within-subject analyses were performed to determine differences between pre- and postimmunization responses to the g209 –2M and HPV peptides and to the negative control HIV peptide after completion of 6 months of vaccination. Pre- versus postimmunization response differences were used as criterion measures in between-group (among subjects) analyses."|Baseline to 6 months|Patients were randomly assigned to two different vaccination schedules: group A received vaccinations every 2 weeks for 6 months (13 total injections), and group B received vaccinations every 3 weeks for 6 months (nine total vaccinations).||% of CD8+ T cells||90% Confidence Interval|Mean
699412|NCT00003896|Secondary|Adverse Events|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Weekly during 6 weeks of protocol treatment|Paclitaxel/CDDP/Liposomal doxorubicin||Participants|||Number
699413|NCT00003896|Primary|Overall Survival|from date of registration to date of death due to any cause. Patients last known to be alive wer censored at date of last contact|Weekly for 6 weeks, then every 6 months for 2 years, then annually thereafter.|All eligible patients who began the treatment intervention.||months||95% Confidence Interval|Median
699414|NCT00003896|Primary|Progression-free Survival|From date of registration to date of progression (as defined per RECIST), symptomatic deterioration or death due to any cause.|Once a month for 6 months, then every 6 months for up to 2 years, then annually thereafter.|Eligible patients who began the treatment intervention||months||95% Confidence Interval|Median
699415|NCT00004143|Primary|Number of Participants With Transplant-related Mortality|Number of patients who died due to transplant-related complications|100 days|||participants|||Number
699416|NCT00004143|Primary|Number of Participants With Grade 3-4 Unexpected Adverse Events|An unexpected adverse event is one that differs in the nature, severity, or frequency from (a) the research procedures that are described in the protocol-related documents, (such as the IRB-approved research protocol and informed consent document) as expected, and/or (b) the characteristics of the subject population being studied.|45 days post transplant|||participants|||Number
699417|NCT00004143|Primary|Number of Patients With Grade 3-4 Acute Graft Versus Host Disease (GVHD)|Number of patients with Grade 3-4 acute Graft Versus Host Disease (GVHD). GVHD will be monitored at least two times per week through day 45, then weekly through day 60 and graded by 2 persons at each institution, to ensure internal consistency in grading.|60 days post transplant|||participants|||Number
699418|NCT00004143|Secondary|Overall Survival|Number of patients alive 2 years after transplant|2 years|||participants|||Number
699419|NCT00004143|Primary|Number of Patients With Platelet Engraftment|Number of patients with platelet engraftment - Platelets > 20,000/μL and hemoglobin level remaining above 10 g/dL without transfusion support, with tests showing at least 2.5% donor cells present. Primary graft failure is defined as absence of establishment of adequate donor hematopoiesis by day 42 with bone marrow cellularity < 5%, peripheral White Blood Count (WBC) < 500/μL, peripheral ANC < 100/μL, and/or platelets < 10,000/μL by day 120 with absence of megakaryocytes in the bone marrow (in the absence of disease relapse).|1 year post transplant|||participants|||Number
699420|NCT00004143|Primary|Number of Patients With Neutrophil Engraftment|Number of patients with neutrophil engraftment: Absolute Neutrophil Count (ANC) > 500/μL and hemoglobin level remaining above 10 g/dL without transfusion support, with tests showing at least 2.5% donor cells present. Primary graft failure is defined as absence of establishment of adequate donor hematopoiesis by day 42 with bone marrow cellularity < 5%, peripheral White Blood Count (WBC) < 500/μL, peripheral ANC < 100/μL, and/or platelets < 10,000/μL by day 120 with absence of megakaryocytes in the bone marrow (in the absence of disease relapse).|1 year post transplant|||participants|||Number
699421|NCT00004146|Primary|Correlation Between PK CAI and Toxicity in This pt Population|PK paramenters including steady state CAI concentrations with toxicity/or drug activity|during treatment|50 subjects had PK samples for analysis||ug/ml||Standard Deviation|Mean
699422|NCT00004146|Primary|Toxicity of CAI When Combined With RT|patients who experienced a grade 3 or higher event considered at least possibly related to CAI|pts were reviewed for toxicity while on treatement - median time of 2 months|pts were treated for a median time of 2 months (23 days to 46 months). patients who experienced a grade 3 or higher event considered at least possibly related to CAI||participants|||Number
699423|NCT00004146|Primary|Overall Survival Rate|estimated period of time event assessed 30 months. event assessed from time of histological diagnosis to death|approximately 30 months|intent to treat pt population. time from histological diagnosis to death.||months||95% Confidence Interval|Median
699424|NCT00004228|Secondary|Percentage of Patients With Overall Survival as Assessed by Time to Death|Overall survival will be computed by measuring the rate of deaths during induction due primarily to treatment toxicity and cumulative incidence of toxic deaths in induction or deaths in remission overall and separately for treatment groups defined by the two design factors.|5 years|There were 19 total ineligible patients, 4 for A0, 2 for A1, 4 for A2, 1 for B2 (CNS+), 1 for B2 (Disseminated), 2 for B1 (CNS-), and 5 for B1 (NHL additional enrollment) not included in outcome measure analysis.||percentage of participants||95% Confidence Interval|Number
699425|NCT00004228|Primary|Event-free Survival|Assessed by time to treatment failure, occurrence of second malignant neoplasm, or death from any cause. Statistical analysis will be to estimate the difference in the proportion of patients treated with each therapy who are long-term event-free survivors due either to the difference between the backbone therapy regimens (CCG BFM vs NHL/BFM-95), or due to the intensification.|5 years|There were 19 total ineligible patients, 4 for A0, 2 for A1, 4 for A2, 1 for B2 (CNS+), 1 for B2 (Disseminated), 2 for B1 (CNS-), and 5 for B1 (NHL additional enrollment) not included in outcome measure analysis.||percentage of particpants||95% Confidence Interval|Number
699426|NCT00003631|Primary|Objective Response|Determine the overall objective response. CR rate [as measured from the start of ICE, (or high dose CTX) to the end of transplant for those who receive it, or the end of ICE for those who do not].Complete response (CR): No evidence of Hodgkin's disease determined clinically, radiologically or pathologically when indicated|2 years|||participants|||Number
699430|NCT00004412|Primary|Healing Defined as a Decrease in Ulcer Area by at Least 25% of the Initial Area|"Treatment Arm: The AB is given as an IV infusion at 500 mg/kg over 6-9 hrs. 5 days per week for 12 weeks. After 12 weeks of therapy, if he ulcer has decreased by 25% , the AB may be continued for additional 8 weeks (twice) or, until ulcer closes plus 2 weeks, additionally.
Ulcers photographed, traced, and ulcer areas calculated by computerized planimetry."|participants were followed for an average of 3 months|Per protocol||percentage of healed ulcers|Participants||Number
699431|NCT00004859|Primary|Overall Survival Time|Survival time is defined as time from study entry to death from any cause|every other month until 24 months from study entry, then every 3 months for year 3, every 4 months for year 4 and every 6 months for year 5|intent to treat analysis in the 546 eligible patients||Months||95% Confidence Interval|Median
699432|NCT00004859|Secondary|Response Rate at Best Response to Treatment|Proportion of patients with complete or partial response using the Response Evaluation Criteria In Solid Tumors (RECIST) v1.0. Complete response is defined as the complete disappearance of all clinically detectable malignant disease for at least 4 weeks. Partial response is defined as greater than or equal to 50% decrease in tumor size for at least 4 weeks without increase in size of any area of known malignant disease of greater than 25%, or appearance of new areas of malignant disease.|every other month until 24 months from study entry, every 3 months for year 3, every 4 months for the 4th year and every 6 months for the 5th year|||Proportion of participants||95% Confidence Interval|Number
699433|NCT00004859|Secondary|Time to Disease Progression|Time to disease progression is defined as the time from randomization to documented disease progression or to death without progression. Patients without documented progression or death reported were censored at the time of the last documented disease evaluation. Progression is defined, using the Response Evaluation Criteria In Solid Tumors (RECIST), as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline.|every other month until 24 months from study entry, every 3 months for year 3, every 4 months for the 4th year and every 6 months for the 5th year|||Months||95% Confidence Interval|Median
699434|NCT00004888|Secondary|Duration of Response|Defined as time from onset of PR or CR, whichever occurred first, until objective evidence of progression.|Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually until death or until reaching full study stop date. Data as of November 21, 2007 is used for this report.|Responders||Months||95% Confidence Interval|Median
699435|NCT00004888|Primary|Summary of Left Ventricular Ejection Fraction Values|This table summarizes the LVEF information at baseline, post Cycle 4, post Cycle 8, and 30 or more days after Cycle 8 on all treated patients and on the eligible subset. LVEF drops reported are absolute (not relative) drops.|Baseline, after cycle 4, after cycle 8, and 30 or more days after last cycle of induction therapy.|All treated patients||LVEF percent||Standard Deviation|Mean
699436|NCT00004888|Secondary|Progression-Free Survival|Progression-Free Survival was defined as time from study entry to progression or to death without documentation of progression. A progression is defined as a significant increase in size of lesions present at the start of therapy or after a response.|Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually until death or until reaching full study stop date. Data as of November 21, 2007 is used for this report.|All eligible patients were included in this analysis. Please note that 2 patients on Arm B died without documentation of progression. Also, 4 patients died or were taken off treatment before follow-up evaluations, and PFS was censored at zero.||months||95% Confidence Interval|Median
699437|NCT00004888|Secondary|Overall Survival||Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually until death or until reaching full study stop date. Data as of November 21, 2007 is used for this report.|All eligible patients were included in this analysis.||months||95% Confidence Interval|Median
699438|NCT00004888|Secondary|Best Overall Response Using Eastern Cooperative Group Solid Tumor Response Criteria.|Please note that overall response includes CR and PR. CR is defined as complete disappearance of all clinically detectable malignant disease for at least 4 weeks. PR is greater than or equal to 50% decrease in tumor size for at least 4 weeks without increase in size of any area of known malignant disease of greater than 25%, or appearance of new areas of malignant disease. No change is defined as no significant change in measurable or evaluable disease for at least 4 weeks. Progression is defined as a significant increase in size of lesions present at the start of therapy or after a response.|Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually until death or until reaching full study stop date. Data as of Nov 21, 2007 is used for this report. Please note that best overall response is reported in the table.|Eligible Patients||participants|||Number
699439|NCT00004888|Primary|Grades of Cardiotoxicity Events in the Subset of Patients Reporting a Cardiotoxicity Event|This table summarizes the cardiotoxicity events of different grades. Grade 1 is a decline of left ventricular ejection fraction(LVEF) >=10% but <20% of baseline value. Grade 2 is LVEF below LLN (50%) or decline of LVEF >=20% of baseline value. Grade 3 is congestive heart failure responsive to treatment. Please note that only a subset of patients reported cardiotoxic events so the totals will not add up to the total number of participants.|Baseline, after cycle 4 (~84 days), after cycle 8 (~168 days), and 30 or more days after last cycle of induction therapy|Treated patients who had a cardiotoxicity event||participants|||Number
699440|NCT00004978|Secondary|Hepatic, Metabolic, and Cardiac Conditions|"Number of participants experiencing a serious non-AIDS event defined as first serious cardiovascular, renal, or hepatic event, or non-AIDS malignancy."|From randomization through study end - median of 7.6 years follow-up|||participants|||Number
699441|NCT00004978|Secondary|Pattern of Use of Prophylaxis for Opportunistic Infections|Number of participants using pneumocystis pneumonia (PCP) prophylaxis at the last attended followup visit.|last followup visit - median of 7.6 years follow-up|Intention to treat (ITT) - Medication use recorded on the last followup visit attended among all participants attending at least one followup visit.||participants|||Number
699442|NCT00004978|Secondary|Grade 4 Signs and Symptoms|Participants with at least one grade 4 sign or symptom (except those limited to a laboratory measurement), other than AIDS-defining conditions. Events were graded according to a standardized toxicity table. Events not specifically contained in the toxicity table were considered Grade 4 if they resulted in extreme limitation in activity or required significant medical intervention/therapy, hospitalization or hospice care. Grade 4 events by type are given under the adverse events section.|From randomization through study end - median of 7.6 years follow-up|||Participants|||Number
699445|NCT00004978|Secondary|Absolute CD4 Cell Counts Averaged Throughout Followup|Average of all available CD4+ cell counts measured at follow-up visits|from randomization through study end - median of 7.6 years follow-up|CD4+ cell counts averaged over all participants with at least one CD4+ measurement recorded during follow-up.||cells/mm^3||Standard Deviation|Mean
699446|NCT00004978|Secondary|Participants With a New Disease Progression Event or Death|Includes first new episode of: CDC Category C 1993 AIDS-defining events plus invasive aspergillosis, bartonellosis, Chagas disease, Herpes zoster, visceral Leishmaniasis, Hodgkin's lymphoma, non-Hodgkin's lymphoma (all cell types), microsporidiosis, nocardiosis, disseminated Penicillium marneffii, extrapulmonary Pneumocystis carinii, and Rhodococcus equi disease|from randomization through 15 November 2008 - median of 7.6 years follow-up|||participants|||Number
699447|NCT00004978|Secondary|Number of Participants Who Died From Any Cause||from randomization through study end - median of 7.6 years follow-up|||participants|||Number
699448|NCT00004978|Secondary|New or Recurrent Serious HIV Disease Progression Event Including Death|Patients with at least one: progressive multifocal leukoencephalopathy, lymphoma, visceral Kaposi's sarcoma, AIDS dementia complex, toxoplasmosis, histoplasmosis, cryptococcosis, Mycobacterium avium complex, wasting syndrome, and cytomegalovirus disease.|from randomization through study end - median of 7.6 years follow-up|ITT||participants|||Number
699449|NCT00004978|Primary|New or Recurrent HIV Disease Progression Event Including Death|Participants who die or experience at least one: any CDC Category C 1993 AIDS-defining events or one of the following: invasive aspergillosis, bartonellosis, Chagas disease, Herpes zoster, visceral Leishmaniasis, Hodgkin's lymphoma, non-Hodgkin's lymphoma (all cell types), microsporidiosis, nocardiosis, disseminated Penicillium marneffii, extrapulmonary Pneumocystis carinii, and Rhodococcus equi disease|from randomization through study end - median of 7.6 years follow-up|ITT||participants|||Number
699450|NCT00004980|Secondary|Responder Status|"Responder defined as a participant who attains an endpoint hallucination change score (HCS) of 5 or lower after 9 active/shame rTMS sessions.
Change in hallucination severity relative to baseline with scores ranging 1 in unit intervals to 20 anchored as follows: 0=hallucinations stopped, 10=no change, 20=hallucinations twice as severe as baseline"|After the 9th active/sham rTMS session (up to 2 weeks or end of intervention)|LOCF||Participants|||Number
699451|NCT00004980|Secondary|Clinical Global Improvement (CGI) Scale After 9 Active/Shame rTMS Sessions|Scaled from 1-7 as follows: 1=dramatically improved, 2=moderately improved, 3=minimally improved, 4=no change, 5=minimally worsened, 6=moderately worsened, 7=dramatically worsened|After the 9th active/sham rTMS session (up to 2 weeks or end of intervention)|||Units on a scale||Standard Deviation|Mean
699452|NCT00004980|Secondary|Change From Baseline in Hallucination Frequency After 9 Active/Shame rTMS Sessions|Difference between baseline hallucination frequency and hallucintion frequency at last assessment. Assessed on the basis of a 0-9 scale, with higher scores being more severe.|After the 9th active/sham rTMS session (up to 2 weeks or end of intervention)|LOCF||Score on a scale||Standard Deviation|Mean
699453|NCT00004980|Primary|Hallucination Change Score (HCS) After 9 Active/Sham rTMS Sessions|Change in hallucination severity relative to baseline with scores ranging 1 in unit intervals to 20 anchored as follows: 0=hallucinations stopped, 10=no change, 20=hallucinations twice as severe as baseline|After the 9th active/sham rTMS session (up to 2 weeks or end of intervention)|Last Observation Carried Forward (LOCF)||Units on a scale||Standard Deviation|Mean
699454|NCT00003901|Secondary|Disease-Free Survival in Bone Marrow Examined Patients|Disease-free survival was defined as the time period from registration to the date of first evidence recurrent disease in patients following curative pulmonary resection or death. Rib bone marrow on participants were examined for occult metastases (OM), diagnosed by cytokeratin immunohistochemistry (IHC).|Up to 5 years|Eligible participants who had underwent pulmonary resection with rib bone marrow were examined for OM||years||95% Confidence Interval|Median
699455|NCT00003901|Secondary|Disease-Free Survival in Lymph Nodes Examined Patients|Disease-free survival was defined as the time period from registration to the date of first evidence recurrent disease in patients following curative pulmonary resection or death. All histologically negative lymph nodes (N0) participants were examined for occult metastases (OM), diagnosed by cytokeratin immunohistochemistry (IHC).|Up to 5 years|Eligible participants with N0 non–small-cell lung cancer who had underwent pulmonary resection and were examined for OM||years||95% Confidence Interval|Median
699456|NCT00003901|Primary|Overall Survival in Bone Marrow Examined Patients|Overall survival was defined as the time period between patient registration and death. Rib bone marrow on participants were examined for occult metastases (OM), diagnosed by cytokeratin immunohistochemistry (IHC).|Up to 5 years|Eligible participants who had underwent pulmonary resection with rib bone marrow were examined for OM||years||95% Confidence Interval|Median
699457|NCT00003901|Primary|Overall Survival in Lymph Nodes Examined Patients|Overall survival was defined as the time period between patient registration and death. All histologically negative lymph nodes (N0) participants were examined for occult metastases (OM), diagnosed by cytokeratin immunohistochemistry (IHC).|Up to 5 years|Eligible participants with N0 non–small-cell lung cancer who had underwent pulmonary resection and were examined for OM||years||95% Confidence Interval|Median
699458|NCT00003907|Secondary|Overall Survival|Overall survival was defined as time from registration to death from any causes.|Assessed every 3 months for 2 years, then every 6 months for 3 year.|all eligible and treated patients||Months||90% Confidence Interval|Median
699459|NCT00003907|Secondary|Tumor Response|Clinical complete response was defined as complete disappearance of all clinically detectable malignant disease for at least 4 weeks. Partial response was defined as >= 50% decrease in tumor size for at least 4 weeks without increase in size of any area of known malignant disease of greater than 25%, or appearance of new areas of malignant disease. Tumor response was defined as complete response + partial response.|Assessed every 6 weeks|all eligible and treated patients||Proportion of participants||90% Confidence Interval|Number
699475|NCT00004547|Secondary|Percentage of Participants Who Had Paclitaxel and 5-fluorouracil (5-FU) Analysis Performed|Paclitaxel and 5-FU levels in plasma and perfusate will be determined by standard high-performance liquid chromatography (HPLC). Samples will be collected just prior to (Time 0) the infusion of the intraperitoneal dwell of 5-FU and paclitaxel, at the following time intervals after the conclusion of the intraperitoneal dwell infusion (15 minutes, 1 hour, 6 hour, 12 hour, 24 hour, 48 hour).|Perioperative day 7-12 after surgery|This outcome measure was not analyzed because it was not feasible (e.g. inadequate samples).|||||
699460|NCT00003907|Primary|Time to Progression|Time to progression was defined as time from embolization to documented disease progression. Patients without documented progression were censored at the time of the last documented disease evaluation or of the last treatment ended, whichever was more recent.Disease progression was defined as significant increase in size of lesions or appearance of new metastatic lesions. Specifically, 1) >=25% increase in the area of any malignant lesions greater than 2 cm² or in the sum of the products of the individual lesions in a given organ site; 2)>=50% increase in the size of the product of diameters if only one lesion is available for measurement and was less than or equal to 2 cm² in size at the initiation of therapy; 3)>=25% increase in the sum of the liver measurements below the costal margins and xyphoid; 4)Appearance of new malignant lesions|Assessed every 3 months for 2 years, then every 6 months for 3 year.|All eligible and treated patients||Months||90% Confidence Interval|Median
699461|NCT00003910|Secondary|Clinical Response||Assessed during the first 4 months of treatment and followed until reaching full study stop date||||||
699462|NCT00003910|Primary|Complete, Partial, and Overall Response Rates of Treatment With MTX, and Also With CY for Patients Failing to Respond to MTX|We will report the overall response rate below. Complete remission requires that all of the following be present for at least four weeks: The patient must have a normal CBC including neutrophil count > 1500/mm3, lymphocyte count< 4000/mm3, hemoglobin > 11 g/dl, and platelet count > 100,000/mm3. In addition, the patient must have a normal LGL count. A complete response will be attained if CD8+ cells were less than 760/mm³. A partial response will be defined as achievement of any one of the following in the absence of CR. The response must last for at least four weeks:In patients being treated for severe neutropenia (less than 500 neutrophils/mm3) an improvement to over 500 neutrophils/mm3 will be considered a partial response, as long as that improvement represents at least a 50% impr|Assessed during the first 4 months, then at least every three months for two years. Then every six months until five years after study entry, and every 12 months thereafter until full study stop date.|Of the 59 pts, 4 were ineligible and excluded from the analysis.||proportion of participants||95% Confidence Interval|Number
699463|NCT00004054|Secondary|Disease Free Survival||From randomization to the first occurrence of biochemical failure, clinical failure (local or distant), death from any cause, or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years.||||||
699464|NCT00004054|Secondary|Distant Metastasis||From randomization to the date of metastatic disease or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years.||||||
699465|NCT00004054|Secondary|Local Progression||From randomization to the date of local progression or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years.||||||
699466|NCT00004054|Secondary|Biochemical Control||From randomization to the date of prostate-specific antigen (PSA) failure per the American Society for Radiation Oncology (ASTRO) definition or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years.||||||
699467|NCT00004054|Primary|Overall Survival (5-year Rate Reported)|Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at date of last contact. This analysis was planned to occur when all patients had been potentially followed for 5 years.|From the date of randomization to the date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years.|All randomized patients.||percentage of participants||95% Confidence Interval|Number
699468|NCT00004092|Secondary|Five-Year Overall Survival|Patients who were still alive were censored at the date of last follow-up. Survival rates were estimates using the Kaplan-Meier method.|Five Years|||percentage of participants||95% Confidence Interval|Number
699469|NCT00004092|Primary|Five-Year Relapse-free Survival|RFS events included death or disease recurrence. Patients who did not experience disease recurrence or death were censored at the date of last follow-up. Survival rates were estimates using the Kaplan-Meier method.|Five years|||percentage of participants||95% Confidence Interval|Number
699470|NCT00004500|Secondary|Number of Participants With Air Leaks|Includes pulmonary interstitial emphysema (PIE), Pneumothorax, Pneumomediastinium, and Pneumopericardium|28 days|"Data from the initial Phase 1/2 trial were used to estimate the number of subjects required for testing the null hypothesis of no difference between treatment groups. A sample size of 100 subjects per group is required to test the hypothesis at a significance level of 0.05 with a power of 80%.
All enrolled infants were analyzed (intent-to-treat)."||participants|||Number
699471|NCT00004500|Secondary|Incidence of Death||28 days|"Data from the initial Phase 1/2 trial were used to estimate the number of subjects required for testing the null hypothesis of no difference between treatment groups. A sample size of 100 subjects per group is required to test the hypothesis at a significance level of 0.05 with a power of 80%.
All enrolled infants were analyzed (intent-to-treat)."||participants|||Number
699472|NCT00004500|Primary|Number of Days Receiving Mechanical Ventilation (MV)|A patient is not receiving MV if he/she is removed from the mechanical ventilator for ≥ 24 hours. If a patient subsequently requires intubation and MV, the additional time will count as days receiving MV.|28 days|"Data from the initial Phase 1/2 trial were used to estimate the number of subjects required for testing the null hypothesis of no difference between treatment groups. A sample size of 100 subjects per group is required to test the hypothesis at a significance level of 0.05 with a power of 80%.
All enrolled infants were analyzed (intent-to-treat)."||days||Standard Deviation|Mean
699473|NCT00004547|Secondary|Signal Transduction Pathways in Tumor Tissue Versus Normal Tissue|Signal transduction pathways were measured using reverse phase protein lysate microarray to determine if the pathways are distinct in tumor versus normal tissue.|once during surgery|This outcome measure was not analyzed because it was not feasible.|||||
699474|NCT00004547|Secondary|Quality of Life Questionnaire Score|"The Short-Form-36 Health Survey (SF-36) and the Functional Assessment of Cancer Therapy Disease Specific for Colorectal Cancer (FACT-C) will be given to the patients upon admission preoperatively, then 6 weeks postoperatively, and then 3, 6, 9, and 12 months for the first year and then every 6 months until the patient goes off study. These forms summarize a participants positive and negative aspects that characterize one's psychological (emotional(, physical, and social well-being at a point in time.
For detailed information about the questionnaires, please see the Protocol Link module."|preop, 6 weeks postop and then 3, 6, 9, and 12 months the first year and then every 6 months until the patient is off study|This outcome measure was not evaluated due to poor patient compliance.|||||
699476|NCT00004547|Primary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|only assessed during the perioperative period (i.e. up to 90 days following surgery)|188 participants is consistent with the total number of participants analyzed (e.g. total from each column in participant flow, 83 P. Meso + 48 L. Grade + 57 Adeno. = 188).||Participants|||Number
699477|NCT00004547|Primary|Number of Participants With a Response|Response is assessed by measuring the time to clinical or radiographic recurrence of disease. Patients will be followed with computed tomography (CT) scans. At any time point where there is evidence of progressive disease in the peritoneal cavity (imageable tumor nodules or new onset of ascites) the patients will be scored as failing within the abdominal cavity.|Patients were assessed every three months for one year and then every 6 months|||Participants|||Number
699478|NCT00004547|Primary|Number of Participants With Disease-free Survival|Participants who achieve either a six or twelve month disease free interval based on radiographic imaging and symptoms.|On study date until the first scan with imageable disease, assessed up to 100 months or more.|This outcome measure was not analyzed because information was not consistently available.|||||
699479|NCT00004562|Secondary|Number of Participants With Secondary Outcomes (Safety Events)|Number of Participants with Secondary Outcomes (death from any cause, nonfatal MI, class IV HF, cardiac death, occurrence of selected clinical outcomes including stroke, hospitalization for CHF, sustained ventricular tachycardia/ventricular fibrillation, ICD implantation, or the composite end point). Events were centrally adjudicated.|Measured over a maximum 9-year follow-up period - 6 year median|||participants|||Number
699480|NCT00004562|Primary|Number of Patients That Had a First Occurrence of the Primary End Point (Composite of Death From Any Cause, Nonfatal MI, or Class IV HF)|Number of Patients with Events (death from any cause, nonfatal reinfarction, and hospitalization for New York Heart Association (NYHA) Class IV congestive heart failure). Events were centrally adjudicated.|Measured over a maximum 9-year follow-up period - 6 year median|||participants|||Number
699481|NCT00004563|Secondary|DLCO|diffusing capacity of the lungs for carbon monoxide|12 months|The Number of Participants Analyzed is not consistent with the Participant Flow for the following reason: a number of the patients who withdrew, had treatment failure, or died had completed at least the six-month visit--for these patients, a generalized estimating-equation regression model was fitted, and data missing at 12 months were imputed.||% of predicted||Standard Error|Mean
699482|NCT00004563|Secondary|Total Lung Capacity|expressed as a percentage of the predicted value|12 months|The Number of Participants Analyzed is not consistent with the Participant Flow for the following reason: a number of the patients who withdrew, had treatment failure, or died had completed at least the six-month visit--for these patients, a generalized estimating-equation regression model was fitted, and data missing at 12 months were imputed.||% of predicted||Standard Error|Mean
699483|NCT00004563|Primary|Forced Vital Capacity|The primary end point was the forced vital capacity (FVC, expressed as a percentage of the predicted value) at 12 months, after adjustment for the baseline FVC.|12 months|The Number of Participants Analyzed is not consistent with the Participant Flow for the following reason: a number of the patients who withdrew, had treatment failure, or died had completed at least the six-month visit--for these patients, a generalized estimating-equation regression model was fitted, and data missing at 12 months were imputed.||% of predicted||Standard Error|Mean
699484|NCT00004635|Secondary|The Number of Participants With Adverse Events|Here are the total number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|60 months|||participants|||Number
699485|NCT00004635|Primary|Time to Progression|Time to progression is defined as follows: if the PSA returns to baseline (defined as the PSA value prior to starting leuprolide or goserelin) or increases to the absolute value of 5 ng/ml.|36 months|Per protocol. First intervention phase-73 participants (thalidomide) were analyzed and 0 was excluded; 74 participants were analyzed (placebo) and 1 was excluded for discrepancy in data entry. Crossover phase-50 participants were analyzed (thalidomide)and 1 was excluded for discrepancy in data entry, 38 participants for placebo and 0 excluded.||months||95% Confidence Interval|Median
699486|NCT00004732|Secondary|Differential Efficacy of CAS and CEA in Male and Female Participants in the Primary Endpoint (Any Periprocedural Stroke, Myocardial Infarction, or Death or Postprocedural Ipsilateral Stroke).|4-year follow-up, proportions reflecting the absolute efficacy of carotid-artery stenting (CAS) over that of carotid endarterectomy (CEA) were based on Kaplan-Meier survival estimates at the end of the 4 years.|4 years|||Percentage||Standard Error|Mean
699487|NCT00004732|Primary|Any Periprocedural Stroke, Myocardial Infarction, or Death During a 30-day Peri-procedural Period, and Postprocedural Ipsilateral Stroke Thereafter, up to 4-years.|The primary aim of CREST is to assess if the efficacy of CAS differs from that of CEA in preventing stroke, myocardial infarction and death during a 30-day peri-procedural period, or ipsilateral stroke over the follow-up period in patients with symptomatic (>=50%) or asymptomatic (>=60%) extracranial carotid stenosis. Four-year follow-up, proportions reflecting the absolute efficacy of carotid-artery stenting (CAS) over that of carotid endarterectomy (CEA) were based on Kaplan-Meier survival estimates at the end of the 4 years.|30 days and 4 years|||Percentage||Standard Error|Mean
699488|NCT00005047|Secondary|Probability of Overall Survival|Patients with tumors demonstrating alteration in p53 compared to patients with no p53 alterations. Probabilities of survival were based on the Kaplan-Meier product-limit method.|5 years|This analysis compares p53 positive patients (combined arms I, II, and IV) to p53 negative patients (arm III).||probability||Standard Error|Median
699489|NCT00005047|Secondary|Probability of Recurrence|"Patients with tumors demonstrating alteration in p53 compared to patients with no p53 alterations.
Probabilities of recurring were based on cumulative incidence curves. Recurrence is defined as first radiological appearance of bladder cancer, per local standard of care."|5 years|This analysis compares p53 positive patients (combined arms I, II, and IV) to p53 negative patients (arm III).||probability||Standard Error|Median
699490|NCT00005047|Secondary|Probability of Overall Survival|p53 positive patients randomized to MVAC (arm I) compared to p53 positive patients randomized to observation (arm II). Survival is calculated from registration to death due to any cause. Probabilities of survival were based on the Kaplan-Meier product-limit method.|5 years|||probability||Standard Error|Median
701581|NCT00054717|Secondary|Virologic Response (VL < 400 Copies/ml) at Week 56|Percentage of participants with Viral Load < 400 copies/mL|Week 56|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
699491|NCT00005047|Primary|Probability of Recurring|"p53 positive patients randomized to MVAC (arm I) compared to p53 positive patients randomized to observation (arm II). Time from registration to the first observation of disease recurrence, censoring patients who died of unrelated causes. Probabilities of recurring were based on cumulative incidence curves.
Recurrence is defined as first radiological appearance of bladder cancer, per local standard of care."|5 years|||probability||Standard Error|Median
699492|NCT00005879|Primary|Number of Participants With Improvement From Baseline in Cytomorphologic Abnormality at 6 Months|"Change (improvement) in categorical descriptor of cytologic abnormality as assigned by the primary cytopathologist.
Categories include: normal (non-proliferative), epithelial hyperplasia, epithelial hyperplasia with atypia."|Baseline to 6 months|Analysis is restricted to subjects that complete the initial 6-month portion of the trial, have a repeat random periareolar fine needle aspiration, and are thus evaluable for change in cytomorphology category.||Participants|||Count of Participants
699493|NCT00005879|Primary|Change in Masood Score|"Change in the semi-quantitative score assigned by the designated cytopathologist.
Range 6-24. Score represents increasing abnormality (i.e., worse appearance) Sum composite of 6 cytomorphological features, each scored as 1-4."|Baseline to 6 months|Analysis is restricted to subjects that complete the initial 6-month portion of the trial, have a repeat random periareolar fine needle aspiration, and are thus evaluable for change in Masood score.||units on a scale||Standard Deviation|Mean
699494|NCT00005901|Primary|Change in Bone Mineral Density in Response to Pamidronate|Dual-energy X-ray Absorptiometry (DXA) measurements were obtained using a Hologic QDR 4500 densitometer and low density software package. Measurements have a precision of 0.011 SD. Raw measurements were converted to Z-scores for analysis using the manufacturer's reference standards for age and pubertal status.|Baseline vs. 6 months after first dose|All subjects received Pamidronate for 3 years.||Z-score||Standard Deviation|Mean
699495|NCT00005901|Primary|Change in Bone Mineral Density in Response to Pamidronate|Dual-energy X-ray Absorptiometry (DXA) measurements were obtained using a Hologic QDR 4500 densitometer and low density software package. Measurements have a precision of 0.011 SD. Raw measurements were converted to Z-scores for analysis using the manufacturer's reference standards for age and pubertal status.|Baseline vs. 36 months after first dose|All subjects received Pamidronate for 3 years.||Z-score||Standard Deviation|Mean
699496|NCT00005901|Primary|Change in Bone Mineral Density in Response to Pamidronate|Dual-energy X-ray Absorptiometry (DXA) measurements were obtained using a Hologic QDR 4500 densitometer and low density software package. Measurements have a precision of 0.011 SD. Raw measurements were converted to Z-scores for analysis using the manufacturer's reference standards for age and pubertal status.|Baseline vs. 30 months after first dose|All subjects received Pamidronate for 3 years.||Z-score||Standard Deviation|Mean
699497|NCT00005901|Primary|Change in Bone Mineral Density in Response to Pamidronate|Dual-energy X-ray Absorptiometry (DXA) measurements were obtained using a Hologic QDR 4500 densitometer and low density software package. Measurements have a precision of 0.011 SD. Raw measurements were converted to Z-scores for analysis using the manufacturer's reference standards for age and pubertal status.|Baseline vs. 24 months after first dose|All subjects received Pamidronate for 3 years.||Z-score||Standard Deviation|Mean
699498|NCT00005901|Primary|Change in Bone Mineral Density in Response to Pamidronate|Dual-energy X-ray Absorptiometry (DXA) measurements were obtained using a Hologic QDR 4500 densitometer and low density software package. Measurements have a precision of 0.011 SD. Raw measurements were converted to Z-scores for analysis using the manufacturer's reference standards for age and pubertal status.|Baseline vs. 18 months after first dose|All subjects received Pamidronate for 3 years.||Z-score||Standard Deviation|Mean
699499|NCT00005901|Primary|Change in Bone Mineral Density in Response to Pamidronate|Dual-energy X-ray Absorptiometry (DXA) measurements were obtained using a Hologic QDR 4500 densitometer and low density software package. Measurements have a precision of 0.011 SD. Raw measurements were converted to Z-scores for analysis using the manufacturer's reference standards for age and pubertal status.|Baseline vs. 12 months after first dose|All subjects received Pamidronate for 3 years.||Z-score||Standard Deviation|Mean
699500|NCT00005906|Secondary|Number of Participants With Liver Function Abnormalities|"One or more abnormality of the following liver function tests:
Alkaline phosphatase above 116 i.u.
SGPT above 41 i.u.
SGOT from 34 i.u.
Total bilirubin above 1.0 mg/dl"|Six months|||Participants|||Number
699501|NCT00005906|Primary|Number of Participants With a Reduction of Pain/Symptoms as Measured by a Simple Numeric Symptom Distress Scale (NDS) to Rate the Severity of Individual Symptoms.|"Octreotide treatment will be considered successful if the reported pain/symptom score is reduced by at least 2 levels at termination of treatment.
A simple visual numeric distress scale ranging from zero to 10 will be employed to rate the severity of individual symptoms. The best score is zero, which means absence of symptoms and the maximal is 10, meaning that the symptoms are very severe."|Six months|Four patients with lymphangioleiomyomatosis and lymphangioleiomyomas and chylous effusions treated with octreotide injections by the subcutaneous route to determine whether the size of the tumors and effusions decrease with the therapy||Participants|||Number
699502|NCT00005906|Primary|Number of Participants With a Reduction in Total Tumor Volume of at Least 20%.|Octreotide treatment will be considered successful if the patient receiving treatment for six months shows a reduction in total tumor mass/ fluid collection or reaccumulation of at least 20%.|Six months|||Participants|||Number
699503|NCT00005908|Primary|Number of Participants, e.g. Responders and Non-responders With a Percent Change in Expression Patterns After Chemotherapy With Changes in Expression Patterns After Chemotherapy in Preclinical Models|Patients were classified as responders or non-responders based on change in tumor size by clinical exam and pathologic response.For instance, patients with a pathological complete response, micro-invasive disease at surgery, or clinical complete response after four cycles of treatment were considered responders. Changes in gene expression associated with treatment was assessed before/after chemotherapy. All gene expression summary intensities below 50 were thresholded to the value of 50 and genes showing variability significantly smaller than the median gene variability were screened out.|6 years|"Specimens from 21 patients. Analysis was per protocol and included only those patients with adequate RNA (ribonucleic acid) for analysis. Since both had the same intervention, the sample size was small, and a dose response was not expected, all patients were analyzed together."||Participants|||Number
699572|NCT00011986|Primary|Progression-free Survival|Hazard ratio for progression free survival. All hazard ratios are expressed relative to the reference regimen: Carbo/taxol.|From the date of enrollment to first progression or death or last contact, if alive and progression free.|||months||95% Confidence Interval|Median
699504|NCT00005908|Primary|Complementary Deoxyribonucleic Acid (cDNA) Expression|Patients were classified as responders or non-responders based on change in tumor size by clinical exam and pathologic response.For instance, patients with a pathological complete response, micro-invasive disease at surgery, or clinical complete response after four cycles of treatment were considered responders. Changes in gene expression associated with treatment was assessed before/after chemotherapy. All gene expression summary intensities below 50 were thresholded to the value of 50 and genes showing variability significantly smaller than the median gene variability were screened out.|6 years|||Participants|||Number
699505|NCT00005908|Primary|Overall Clinical Response Rate|Overall response rate is defined as the percentage of participants with a CR (complete disappearance of all target lesions), PR (a 30% decrease in the sum of the longest diameter of target lesions) determined by clinical measurements per the Response Evaluation Criteria in Solid Tumors (RECIST) and/or a complete pathologic response (disappearance of all invasive tumor pathologically or presence of ductal carcinoma in situ) per the Chevallier criteria. For details about the RECIST or Chevallier criteria see the protocol link module.|6 years|Combined data from 2 dose levels in 29 evaluable patients.||Percentage of participants|||Number
699506|NCT00005908|Primary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|6 years|||Participants|||Number
699507|NCT00005937|Primary|Red Blood Cell Transfusion Independence|Red blood cell transfusion independence was documented as time from last transfusion of red cells to last day of transfusion free follow-up. Independence or response to the intervention was assessed by weekly blood counts. Transfusion independence was defined as no transfusion requirement for a 3 month period. Complete hematologic response is defined as the normalization of affected cells lines and less than 5% marrow blasts present. Partial hematologic response is defined as greater than 50% improvement from baseline to normal levels of all cell counts and greater than 50% decrease in marrow blasts.|6 months|||participants|||Number
699508|NCT00005947|Secondary|Overall Survival|Overall Survival|From randomization to 36 months|||Months||95% Confidence Interval|Median
699509|NCT00005947|Primary|Time to Objective Disease Progression|The time to objective disease progression in patients with asymptomatic metastatic hormone-refractory prostate cancer treated with APC8015 (sipuleucel-T).|36 months from randomization|all randomized participants||Weeks||95% Confidence Interval|Median
699510|NCT00005957|Secondary|Disease-free Survival|Disease-free survival (including locoregional and distant disease)|10 years|Intention-to-treat||percentage of disease-free at 10 years||95% Confidence Interval|Number
699511|NCT00005957|Primary|Overall Survival|Duration of study|10 years|Intention-to-treat||percentage of alive at 10 years||95% Confidence Interval|Number
699512|NCT00006011|Primary|Recurrence-Free Survival of Eligible Patients Who Received a Random Treatment Allocation.|"Recurrence is defined as discovery of disease not previously present by clinical, radiographic, and/or laboratory means or as a 50% or greater increase in the product of two perpendicular diameters from any documented lesion.
Recurrence-free survival is defined as time in months the patient is alive, recurrence-free starting from the date of randomization.
Intention to treat among eligible participants who receive random treatment allocation."|study entry up to 5 years post treatment|||participants|||Number
699513|NCT00006409|Primary|MET-weighted MVPA: Daily Minutes of Moderate-to-vigorous Physical Activity (MVPA) Weighted by Metabolic Equivalent of Task (MET)||Post-3 year intervention|||Minutes of MET-weighted MVPA˙||Standard Error|Mean
699514|NCT00006409|Primary|MET-weighted MVPA: Daily Minutes of Moderate-to-vigorous Physical Activity (MVPA) Weighted by Metabolic Equivalent of Task (MET)||Post-2 year intervention|||Minutes of MET-weighted MVPA˙||Standard Error|Mean
699515|NCT00006478|Secondary|Changes in Quantitative Bcl-2|To evaluate changes in quantitative bcl-2 of the blood and bone marrow prior to and at various time points following the series of idiotype vaccines.|1 year post transplant evaluation and then annually until disease progression||||||
699516|NCT00006478|Secondary|Toxicity|To evaluate the safety and toxicity of idiotype vaccine with KLH and GM-CSF adjuvant in the post-transplant setting|At each immunization and at study completion||||||
699517|NCT00006478|Secondary|Safety|To evaluate the safety and toxicity of idiotype vaccine with KLH and GM-CSF adjuvant in the post-transplant setting|At each immunization and at study completion||||||
699518|NCT00006478|Primary|Number of Participants With Humoral and Cellular Immune Response|evaluate the humoral immune responses and cellular immune responses to idiotype vaccine with KLH and GM-CSF adjuvant given to patients with follicular lymphoma following high-dose chemotherapy and autologous stem cell transplantation|immune responses will be obtained prior to first immunization (baseline), prior to the 5th, 6th, 7th immunization series and 2 weeks following administration of the 7th immunization series. And then obtained annually until disease progression|NO formal analysis was completed as this trial was halted prematurely. Thirty patients were to be enrolled in the protocol so that 15 patients would be evaluable at the end of the immunization process. Of the 19 patients enrolled on the trial, only 12 went on to complete the vaccine series.||Participants||95% Confidence Interval|Number
699519|NCT00006489|Secondary|Penn Alcohol Cravings Scale|The Penn Alcohol Craving Scale is a 5-item self-report measure. It assesses alcohol craving during the prior week. Total scores on this measure range from 0 to 30, with higher scores indicating a higher level of craving.|Week 0 (Pretreatment), Week 24 (Posttreatment), Week 52 (Follow-up)|||percentage of days||95% Confidence Interval|Mean
699520|NCT00006489|Primary|Drinking Timeline Follow-back Interview (TFBI)|The TFBI is an interview that utilizes a calendar method to assess when and how much alcohol was consumed by the participant. At Week 0 (Pretreatment), Week 24 (Posttreatment), and Week 52 (Follow-up), alcohol consumed in the past 90 days was assessed. This measure was then used to calculate the percentage of days drinking in the past 90 days at each time point. Higher scores for percentage of days drinking indicate worse drinking outcomes.|Week 0 (Pretreatment), Week 24 (Posttreatment), Week 52 (Follow-up)|||percentage of days||95% Confidence Interval|Mean
699521|NCT00006489|Primary|Posttraumatic Stress Disorder (PTSD) Symptom Scale - Interview (PSS-I-IV)|The PSS-I-IV is a clinician-rated interview that evaluates PTSD symptoms on a frequency/severity scale corresponding to the DSM-IV symptom criteria. The measure has a total score range from 0 to 51, with higher scores indicating more severe PTSD symptoms.|Week 0 (Pretreatment), Week 24 (Posttreatment), Week 52 (Follow-up)|||units on a scale||95% Confidence Interval|Mean
699573|NCT00011986|Primary|Overall Survival||Up to 9 years||||||
699522|NCT00006604|Secondary|Change in CD4 Percent From Baseline to Week 96||Baseline, Week 96|"Patients accrued to the final recommended dose for each group (with evaluable CD4 data).
CD4 changes from baseline were calculated in an ‘as-treated’ analysis’ such that only patients who tolerated the study treatment, and who had evaluable data were included in this analysis."||percentage of total lymphocytes||Full Range|Median
699523|NCT00006604|Secondary|Change in CD4 Percent From Baseline to Week 48||Baseline, Week 48|"Patients accrued to the final recommended dose for each group (with evaluable CD4 data).
CD4 changes from baseline were calculated in an ‘as-treated’ analysis’ such that only patients who tolerated the study treatment, and who had evaluable data were included in this analysis."||percentage of total lymphocytes||Full Range|Median
699524|NCT00006604|Secondary|Change in CD4 Percent From Baseline to Week 20||Baseline, Week 20|"Patients accrued to the final recommended dose for each group (with evaluable CD4 data).
CD4 changes from baseline were calculated in an ‘as-treated’ analysis’ such that only patients who tolerated the study treatment, and who had evaluable data were included in this analysis."||percentage of total lymphocytes||Full Range|Median
699525|NCT00006604|Secondary|Change in CD4 Count (Cells/mm^3) From Baseline to Week 96||Baseline, Week 96|"Patients accrued to the final recommended dose for each group (with evaluable CD4 data).
CD4 changes from baseline were calculated in an ‘as-treated’ analysis’ such that only patients who tolerated the study treatment, and who had evaluable data were included in this analysis."||cells/mm^3||Full Range|Median
699526|NCT00006604|Secondary|Change in CD4 Count (Cells/mm^3) From Baseline to Week 48||Baseline, Week 48|"Patients accrued to the final recommended dose for each group (with evaluable CD4 data).
CD4 changes from baseline were calculated in an ‘as-treated’ analysis’ such that only patients who tolerated the study treatment, and who had evaluable data were included in this analysis."||Cells/mm^3||Full Range|Median
699527|NCT00006604|Secondary|Change in CD4 Count (Cells/mm^3) From Baseline to Week 20||Baseline, Week 20|"Participants accrued at the final recommended dose for each group (with evaluable CD4 data).
CD4 changes from baseline were calculated in an ‘as-treated’ analysis’ such that only patients who tolerated the study treatment, and who had evaluable data were included in this analysis."||Cells/mm^3||Full Range|Median
699528|NCT00006604|Primary|Pharmacokinetic (PK) Parameter: Clearance (CL/F)|Pharmacokinetics were determined by non-compartmental analysis and Apparent oral clearance (CL/F) was calculated as ATV dose divided by AUC0–24hr.|Week 1 (Day 7) Intensive PK-24 hr (Pre-dose, 1, 2, 3, 4, 6, 8, and 12 hours post-dose and the following day at 24-hours post-dose)|Participants with intensive pharmacokinetic (PK) results at the final recommended dose for each group.||L/hr/m^2||Inter-Quartile Range|Median
699529|NCT00006604|Primary|Pharmacokinetic (PK) Parameter: Maximum Plasma Concentration (Cmax)|Pharmacokinetics were determined by non-compartmental analysis and Maximum concentration (Cmax) was determined visually.|Week 1 (Day 7) Intensive PK-24 hr (Pre-dose, 1, 2, 3, 4, 6, 8, and 12 hours post-dose and the following day at 24-hours post-dose)|Participants with intensive pharmacokinetic (PK) results at the final recommended dose for each group.||ng/mL||Inter-Quartile Range|Median
699530|NCT00006604|Primary|Pharmacokinetic (PK) Parameter: Minimum Plasma Concentration (C24)|Pharmacokinetics were determined by non-compartmental analysis. C24 determined visually, except in the instance when the patient re-dosed the study medication prior to the 24 hour blood draw or the 24 hour level was not obtained, in which case the C24 was calculated from the elimination rate (ke) and the last measured concentration.|Week 1 (Day 7) Intensive PK-24hr (Pre-dose, 1, 2, 3, 4, 6, 8, and 12 hours post-dose and the following day at 24-hours post-dose)|Participants with intensive pharmacokinetic (PK) results at the final recommended dose for each group.||ng/mL||Inter-Quartile Range|Median
699531|NCT00006604|Primary|Pharmacokinetic (PK) Parameter: Area Under the Curve (AUC24h)|Pharmacokinetics were determined by non-compartmental analysis and AUC0–24hr calculated by the linear trapezoidal method.|Week 1 (Day 7) Intensive PK-24hr (Pre-Dose, 1, 2, 3, 4, 6, 8, and 12 hours post-dose and the following day at 24-hours post-dose)|Participants with intensive pharmacokinetic (PK) results at the final recommended dose for each group.||ng*hr/mL||Inter-Quartile Range|Median
699532|NCT00006604|Secondary|Percentage of Participants With HIV RNA <400 Copies/mL at Week 96|Over the duration of the protocol, the assay used to determine Plasma HIV RNA levels was transitioned from the Amplicor HIV-1 Assay to the Amplicor HIV-1 Monitor 1.5 UltraSensitive Assay (Roche Molecular Systems, Branchburg, NJ) to finally the Abbott Real time HIV-1 RNA assay. The assays were performed according to the manufacturer’s instructions in a laboratory accredited by the College of American Pathologists and certified by the NIH Virology Quality Assurance (VQA) in the United States, and VQA certified in South Africa.|Week 96|"Participants accrued at the final recommended dose for each group (with evaluable HIV-RNA data).
Virologic response, defined as achieving HIV-RNA < 400 copies/mL and remaining on treatment, was analyzed using an ‘intent-to-treat’ (ITT) approach, in which children who discontinued study treatment for any reason were considered failures."||percentage of participants||95% Confidence Interval|Number
699533|NCT00006604|Secondary|Percentage of Participants With HIV RNA <400 Copies/mL at Week 48|Over the duration of the protocol, the assay used to determine Plasma HIV RNA levels was transitioned from the Amplicor HIV-1 Assay to the Amplicor HIV-1 Monitor 1.5 UltraSensitive Assay (Roche Molecular Systems, Branchburg, NJ) to finally the Abbott Real time HIV-1 RNA assay. The assays were performed according to the manufacturer’s instructions in a laboratory accredited by the College of American Pathologists and certified by the NIH Virology Quality Assurance (VQA) in the United States, and VQA certified in South Africa.|Week 48|"Participants accrued at the final recommended dose for each group (with evaluable HIV-RNA data).
Virologic response, defined as achieving HIV-RNA < 400 copies/mL and remaining on treatment, was analyzed using an ‘intent-to-treat’ (ITT) approach, in which children who discontinued study treatment for any reason were considered failures."||percentage of participants||95% Confidence Interval|Number
699568|NCT00010803|Secondary|Progression of Cognitive Decline in Standardized Z-score Scale. Higher Z-scores Indicate Worse Performance.|Rate of annual change by cognitive domain in standardized Z-score scale. Higher Z-scores indicate worse performance. Best score = -2.0 Z-score change per year (improvement); worse score = 2.0 Z-score change per year (decline).|6 months/annually|Final test scores were imputed for participants who did not have a cognitive exam during the year before death (n=234) or dropout (n=154) or during the month before censoring for dementia (n=70). Factors in imputed model included treatment group, demographic and health history variables, study site, and other cognitive scores. Higher Z-scores worse||Z-score units||95% Confidence Interval|Mean
699534|NCT00006604|Secondary|Percentage of Participants With HIV RNA <400 Copies/mL at Week 24|Over the duration of the protocol, the assay used to determine Plasma HIV RNA levels was transitioned from the Amplicor HIV-1 Assay to the Amplicor HIV-1 Monitor 1.5 UltraSensitive Assay (Roche Molecular Systems, Branchburg, NJ) to finally the Abbott Real time HIV-1 RNA assay. The assays were performed according to the manufacturer’s instructions in a laboratory accredited by the College of American Pathologists and certified by the NIH Virology Quality Assurance (VQA) in the United States, and VQA certified in South Africa.|Week 24|"Participants accrued at the final recommended dose for each group (with evaluable HIV-RNA data).
Virologic response, defined as achieving HIV-RNA < 400 copies/mL and remaining on treatment, was analyzed using an ‘intent-to-treat’ (ITT) approach, in which children who discontinued study treatment for any reason were considered failures."||percentage of participants||95% Confidence Interval|Number
699535|NCT00006604|Primary|Number of Participants Who Died||From study entry up to week 96|Participants accrued at the final recommended dose for each group.||participants|||Number
699536|NCT00006604|Primary|Number of Participants Who Experienced a Safety Endpoint of Interest Attributed to ATV|"Total Bilirubin >= 5.1xULN, ECG Events and Other Grade 3+ toxicities attributed to study treatment.
The AEs were graded by the clinicians according to the Division of AIDS (DAIDS) Toxicity Table (see references in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening, Grade 5=Death. Relationship to study treatment was determined by the study team."|From study entry up to week 96|Patients accrued at the final recommended dose for each group.||participants|||Number
699537|NCT00006721|Primary|Overall Survival at 5 Years|Measured from date of registration to date of death due to any cause|0-5 years|All eligible patients who started treatment were included in the analysis. The participants in CHOP alone arm were not assessed due to early closure.||percentage of participants|||Number
699538|NCT00006721|Primary|Overall Survival at 2 Years|Measured from date of registration to date of death due to any cause|0-2 years|All eligible patients who started treatment were included in the analysis. The participants in CHOP alone arm were not assessed due to early closure.||percentage of participants|||Number
699539|NCT00006721|Primary|Progression-free Survival at 5 Years|Measured from time of registration to date of of first observation of progression/relapse, or death due to any cause, or last contact date|0-5 years|All eligible patients who started treatment were included in the analysis. The participants in CHOP alone arm were not assessed due to early closure.||percentage of participants|||Number
699540|NCT00006721|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 2.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal|Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment|Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 2.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included||Participants|||Number
699541|NCT00006721|Secondary|Objective Response (Confirmed and Unconfirmed Complete and Partial Responses)|Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.|Assessed 200 days and 365 days after initiation of therapy and then every 6 months until death|All eligible patients who started treatment were included in the analysis. The participants in CHOP alone arm were not assessed due to early closure.||participants|||Number
699542|NCT00006721|Primary|Progression-free Survival at 2 Years|Measured from time of registration to date of of first observation of progression/relapse, or death due to any cause, or last contact date|0-2 years|All eligible patients who started treatment were included in the analysis. The participants in CHOP alone arm were not assessed due to early closure.||percentage of participants|||Number
699543|NCT00006903|Secondary|Toxicity of Fulvestrant by Common Toxicity Criteria||During study treatment and up to 30 days after stopping study||||||
699544|NCT00006903|Primary|Clinical Response by RECIST Criteria of Estrogen Receptor Expression||Every other cycle (every 8 weeks) until disease progression is documented or adverse events preclude further treatment.||||||
699545|NCT00006903|Primary|Clinical Response by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria Evaluated Every 8 Weeks|"Primary outcome measured according to RECIST v1.0 Best Response:
Complete Response (CR) is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart
Disease Progression is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.
Partial Response (PR) is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of nontarget lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required
Stable Disease is any condition not meeting the above criteria.
Indeterminate is defined as having no repeat tumor assessments following initiation of study therapy for reasons unrelated to symptoms or signs of disease."|Response was measured every other cycle (every 8 weeks) until disease progression is documented or adverse events preclude further treatment.|Total number eligible and treated participants within groups defined by estrogen receptor status in metastatic tumor.||participants|||Number
699546|NCT00006916|Primary|Overall Survival|This study stopped accrual early with 19 subjects accrued out of 72 planned therefore no analyses were performed.|From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 18 months.||||||
699569|NCT00010803|Secondary|Number of Participants With the Indicated Cardiovascular Disease or Mortality|Myocardial infarction (MI), angina, stroke (CVA), transient ischemic attack (TIA), combined coronary heart disease (CHD) (MI/angina), combined cerebrovascular (CVA/TIA), peripheral vascular disease, and mortality|6 months|Total cohort of 3069 based on same design as primary outcome, ITT.||Participants|||Number
699547|NCT00007345|Secondary|Multidrug Resistance Protein 1 (MDR1) or ATP-binding Cassette Sub-family B Member 1 (ABCB1) Gene Expression|Total ribonucleic acid (RNA) was isolated from peripheral blood mononuclear cells or patient tissue biopsies and analyzed by quantitative polymerase chain reaction (qPCR). Expression of MDR-1/ABCB1 was determined by qPCR relative to an RNA standard, then normalized to ribosomal RNA (rRNA). Fold change is calculated by dividing the level of MDR-1 in a treated sample (at 4, 24, and 48 hours) measured by qPCR, divided by MDR-1 in the pre-treatment sample. We considered a ≥ 2-fold change a measurable difference, and indicative of successful HDAC inhibition by romidepsin (depsipeptide).|4 hours, 24 hours, and 48 hours after Romidepsin|ABCB1 expression of all samples at pretreatment was designated as 1; values at other time points for each patient were calculated relative to the corresponding pretreatment value.||Fold change||Full Range|Median
699548|NCT00007345|Secondary|Fold Change in Histone Acetylation|Fold change is calculated by dividing the level of histone acetylation in a treated sample (at 4, 24, and 48 hours) measured as intensity on a dot blot immunoassay, divided by the intensity in the pre-treatment sample. We considered a ≥ 2-fold change a measurable difference, and indicative of successful HDAC inhibition by romidepsin (depsipeptide).|4 hours, 24 hours, and 48 hours after Romidepsin|Global histone acetylation of all samples at pretreatment was designated as 1; values at other time points for each patient were calculated relative to the corresponding pretreatment value.||Fold change||Full Range|Median
699549|NCT00007345|Secondary|Time to Progression|Time to progression is defined from the first day of therapy until documentation of progressive disease. Progressive disease (PD) is at least a 20% increase in the sum of the target lesions, or the appearance of one or more new lesions. Lymph node disease was assessed bi-dimensionally using the International Working Group (IWG) criteria. Bone marrow involvement, as recommended by IWG criteria, and presence of circulating malignant T-cells ascertained by flow cytometry.|Until disease progression, or 30 days following off study date|||Months||95% Confidence Interval|Median
699550|NCT00007345|Secondary|Median Number of Cycles of Depsipeptide Administered|Participants were administered Depsipeptide and cycles (each cycle is 21 days) were monitored from the prescribed dose or higher to determine reductions (if needed) to maintain tolerability.|83 cycles (i.e., each cycle is 21 days)|||Cycles per patient||Full Range|Median
699551|NCT00007345|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|147 months and 5 days|||participants|||Number
699552|NCT00007345|Primary|Duration of Response (DOR)|DOR is defined as the date response was noted until disease was no longer considered to be responding. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria and the International Working Group Criteria (IWG).Complete response (CR) required clearing of all known disease sites. Partial response (PR) required documented response in skin (≥ 30% per RECIST) or lymph nodes (≥ 50% per the International Working Group (IWG) criteria, with response in both compartments for a determination of PR, IWG guidelines. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Progressive disease (PD) is at least a 20% increase in the sum of the target lesions, or the appearance of one or more new lesions. Lymph node disease was assessed bi-dimensionally using the IWG criteria. Bone marrow involvement, as recommended by IWG criteria, and presence of circulating malignant T-cells ascertained by flow cytometry.|up to 127 months|||Months||Full Range|Median
699553|NCT00007345|Primary|Number of Participants With a Response|A rigorous composite assessment was employed with uni-dimensional measurements of skin and visceral disease sites assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) required clearing of all known disease sites. Partial response (PR) required documented response in skin (≥ 30% per RECIST) or lymph nodes (≥ 50% per the International Working Group (IWG) criteria, with response in both compartments for a determination of PR, IWG guidelines. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Progressive disease (PD) is at least a 20% increase in the sum of the target lesions, or the appearance of one or more new lesions. Lymph node disease was assessed bi-dimensionally using the IWG criteria. Bone marrow involvement, as recommended by IWG criteria, and presence of circulating malignant T-cells ascertained by flow cytometry.|up to 56.5 days|Two participants were excluded. After further analysis it was determined that the participants did not have PTCL but a different form of lymphoma that was not known at the onset of enrollment.||participants|||Number
699554|NCT00007475|Secondary|Determine Whether Renal Transplantation in Patients Whose Elevated FPF Levels Have Been Reduced for a Sustained Period is Associated With a Reduced Prevalence of Recurrent FSGS.|"Provisional assay of a molecular identification of FPF (current candidate: cardiotrophin-like cytokine 1) using an isolation approach based on sequential precipitation results in a 100-fold purification.
Note: Focal segmental glomerulosclerosis Permeability Factor (FPF) assay had not yet been developed to an extent that it could be applied to all enrollees in the current trial; provisional values were assayed for 3 of the first 4 enrollees using a version implemented by Dr. Virginia Savin, whose lab is actively investigating the above isolation approach, but the fraction remains a complex mixture on SDS-PAGE (Sharma 1999). Other investigators of FPF, mentioned here for interested readers of this trial report, include:
Terry Phillips at NIH developed an assay that looked promising prior to his retirement.
Avi Rosenberg, NCI has developed promising ELISA-style assay, and mass spectrometry assay, being refined."|End of study|Participants whose post-transplantation follow-up yields 1 or more assayed FPF levels|||||
699570|NCT00010803|Primary|Number of Participants With Incident Dementia|All cause dementia based on DSM-IV criteria as determined by an expert panel of clinicians using an adjudication process. A full neuropsychological battery was administered annually, or at 6 month visit if there was a diagnosis of dementia or initiation of medication for dementia by private physician, or change in Modified Mini Mental State Exam (3MSE), Clinical Dementia Rating (CDR), or Alzheimer Disease Assessment Scale (ADAS-Cog). Decline on tests scores based on an algorithm resulted in a neurological exam and brain imaging. These data were used in the adjudication process.|Brief neuropsychological testing every 6 months, detailed testing annually, average 6.1 years follow up|Subjects developing incident dementia during trial in each group, intention to treat (ITT).||Participants|||Number
699571|NCT00011986|Primary|Frequency and Severity of Observed Adverse Effects Assessed by Common Toxicity Criteria Version 2.0||Up to 9 years||||||
699574|NCT00012012|Secondary|Distant Metastases||From registration to date of distant mets or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years.||||||
699555|NCT00007475|Secondary|Correlate the Effect of Immunosuppressive Agents Which Reduce Proteinuria in Recurrent FSGS With the Effect on FPF Levels|"Provisional assay of a molecular identification of FPF (current candidate: cardiotrophin-like cytokine 1) using an isolation approach based on sequential precipitation results in a 100-fold purification.
Note: Focal segmental glomerulosclerosis Permeability Factor (FPF) assay had not yet been developed to an extent that it could be applied to all enrollees in the current trial; provisional values were assayed for 3 of the first 4 enrollees using a version implemented by Dr. Virginia Savin, whose lab is actively investigating the above isolation approach, but the fraction remains a complex mixture on SDS-PAGE (Sharma 1999). Other investigators of FPF, mentioned here for interested readers of this trial report, include:
Terry Phillips at NIH developed an assay that looked promising prior to his retirement.
Avi Rosenberg, NCI has developed promising ELISA-style assay, and mass spectrometry assay, being refined."|End of study|Participants with FPF levels assayed following immunosuppressive therapies (currently none). Note: its assay had not yet been developed to an extent that it could be applied beyond the provisional values assayed for 3 of the first 4 enrollees using a version implemented by Dr.Virginia Savin, VA Medical Center/Kidney Institute, Kansas City, Missouri|||||
699556|NCT00007475|Secondary|Define the Kinetics of FPF in FSGS Patients Receiving Immunomodulatory Therapy or Plasma Exchange.|"Provisional assay of a molecular identification of FPF (current candidate: cardiotrophin-like cytokine 1) using an isolation approach based on sequential precipitation results in a 100-fold purification.
Note: Focal segmental glomerulosclerosis Permeability Factor (FPF) assay had not yet been developed to an extent that it could be applied to all enrollees in the current trial; provisional values were assayed for 3 of the first 4 enrollees using a version implemented by Dr. Virginia Savin, whose lab is actively investigating the above isolation approach, but the fraction remains a complex mixture on SDS-PAGE (Sharma 1999). Other investigators of FPF, mentioned here for interested readers of this trial report, include:
Terry Phillips at NIH developed an assay that looked promising prior to his retirement.
Avi Rosenberg, NCI has developed promising ELISA-style assay, and mass spectrometry assay, being refined."|End of study|||1- albumin glomerular permeability ratio||Full Range|Mean
699557|NCT00007475|Secondary|Comparison of RNA Expression Profiles in PBMC From Patients With FPF, Without FPF and Control Subjects|"No RNA expression profiles have been obtained as FSGS Permeability Factor (FPF) levels NOT available -- its assay has not yet been developed to an extent that it could be applied to all enrollees of this current trial.
Note that provisional values (targeting current candidate molecule: cardiotrophin-like cytokine 1) were assayed for 3 of the first 4 enrollees using assay by Dr. Virginia Savin, whose lab is actively investigating a molecular identification of FPF using an isolation approach based on sequential precipitation results in a 100-fold purification, but the fraction remains a complex mixture on SDS-PAGE (Sharma 1999). Other investigators of FPF include:
Terry Phillips at NIH developed an assay that looked promising but after his retirement it has not been possible for other researchers to get this working.
Avi Rosenberg, NCI has developed a promising ELISA-style assay, as well as some work in a mass spectrometry assay, and this is being further refined."|End of study|Participants with FPF, without FPF and control subjects who have also had RNA expression profiling done in PBMCs.|||||
699558|NCT00007475|Primary|Reduction in Proteinuria in Recurrent FSGS Following Renal Transplant With Plasma Exchange and Cyclophosphamide.|"Outcomes for FSGS occurring in native kidneys:
A. Complete remission: proteinuria <0.3 g/d ; B. Partial remission: proteinuria between 0.3 and 2 g/d ; C. Incomplete response: proteinuria between 2 and 3.5 g/d ; D. Relapse: return to proteinuria ≥3.5 g/d ; Note that counts within each category A-D may be summarized relative to remaining categories, as a proportion (relative to complement of the whole group count) with calculations implicitly based on zero/one valued binary variables, whose means are proportions, so to report 95% confidence intervals calculated using an exact binomial distribution."|every 3 months up to a year followed with native kidneys|all participants, regardless of amount of follow-up||proportion of participants with outcome||95% Confidence Interval|Mean
699559|NCT00007644|Primary|All Cause Mortality|Bi-annually, from date of randomization until the date of death from any cause, assessed up to 8 years.|bi-annual|||percentage of participants||95% Confidence Interval|Number
699560|NCT00007644|Primary|All Cause Mortality|Annually, from date of randomization until the date of death from any cause, assessed up to 8 years.|Annual||||||
699561|NCT00005669|Secondary|Change in Body Fat by Bod Pod|Change in body fat mass measured by air displacement plethysmography (kg)|6 months|||kg||95% Confidence Interval|Mean
699562|NCT00005669|Secondary|Change in Body Fat by DEXA|Change in body fat mass by Dual Energy X-Ray Absorptiometry (kg)|6 months|ITT, multiple imputation model for missing data under a missing-at-random assumption||kg||95% Confidence Interval|Mean
699563|NCT00005669|Secondary|Change in Body Weight|Change in body weight (kg)|6 months|||kg||95% Confidence Interval|Mean
699564|NCT00005669|Secondary|Change in Body Weight as Determined by BMI|Change in body weight as determined by body mass index (kg/m2)|6 months|||kg/m2||95% Confidence Interval|Mean
699565|NCT00005669|Primary|Changes in Body Weight as Determined by Body Mass Index-standard Deviation Score (BMI-SDS).|Change in Body Mass Index standard deviation score (BMI-SDS) determined using tables created by the CDC in 2000. BMI-SDS is a unitless transformation of the body mass index (measured in kg divided by the squared height in meters) using the L M S method. Possible values range from -3 to +3. See http://www.cdc.gov/growthcharts/percentile_data_files.htm for details.|6 months|||Units on a scale||95% Confidence Interval|Mean
699566|NCT00010439|Secondary|Participants (1) With Fractures Before and After Therapy,(2)Analysed for Average Changes From High to Near Normal Mineral Apposition Rate (MAR) After Therapy,(3)Analysed for Average Insignificant Changes in Biochemical Markers After Therapy.|Participants (pts) with fractures bef.and aft.therapy; pts analysed for average changes in mineral apposition rate (MAR) (high (1.9um/day) to near normal (1.2 um/day)as revealed in bone biopsies. MAR is the distance between the two tetracycline labels (um/day). The data represent the average of 10-17 measurements of the disltance obtained by reading 2-7 individual slides of bone biopsy and pts analysed for average insignificant biochemical markers (serum bone specific alkaline phosphatase for bone formation and urinary N-telopeptide for resorption)to determine the effect of therapy.|Before and 12 months after treatment with alendronate|Per protocol||participants|||Number
699567|NCT00010439|Primary|Number of Participants With Increased Bone Mineral Density|Number of participants with increase in bone mineral density at Lumbar Spine and/or Hip at 12 months as compared to the bone mineral density at Lumbar Spine and/or Hip obtained before therapy (baseline values)|at 12 months|per protocol||participants|||Number
699576|NCT00012012|Primary|Number of Patients With Acute Grade 3/4 Toxicity (Excluding Grade 3 Leukopenia)|The second part of this study (second arm) was designed to detect a 40% relative reduction (absolute from 77% to 46%) in the acute grade 3/4 toxicity (excluding grade 3 leukopenia) rate, with the addition of amifostine. A one-sided alpha of 0.05 and 80% power required 16 evaluable patients to detect the hypothesized difference. If ≤ 8 had the toxicity, it would be concluded that adding amifostine decreased this toxicity rate by at least 40%.|From start of treatment to 90 days|All eligible patients||participants|||Number
699577|NCT00012012|Primary|Rate of Acute Grade 3/4 Toxicity (Excluding Grade 3 Leukopenia)|To determine the feasibility and tolerance of extended-field external radiotherapy to the pelvis and para-aortic region and intracavitary irradiation combined with weekly cisplatin using the rate of acute grade 3/4 toxicity rate (excluding grade 3 leukopenia). The first part of this study was designed to determine the acute grade 3/4 toxicity rate (excluding grade 3 leukopenia), to have a starting point for the second part (second arm) of the study.|From start of treatment to 90 days|All eligible patients||percentage of participants||95% Confidence Interval|Number
699578|NCT00012298|Secondary|Tumor Response Rate (Phase II)|Calculated by the number of tumor responses divided by the total number of evaluable patients. An exact binomial confidence interval will be calculated.|Assessed up to 5 years||||||
699579|NCT00012298|Secondary|Time to Disease Progression (Phase II)|Estimated using the method of Kaplan-Meier.|From registration to the earliest date documentation of > disease progression, assessed up to 5 years||||||
699580|NCT00012298|Secondary|Survival (Phase II)|Estimated using the method of Kaplan-Meier.|From registration to death due to any cause, assessed up to 5 years||||||
699581|NCT00012298|Secondary|Appearance of Tumor and Normal Organ Images on the Second In2B8 Scan (Phase I)|Calculated from the serial gamma camera images. Compared using a signed-rank-test. Scatter plots will be used to further explore relationships between these residence times and Bland- Altman methods can be used to assess the agreement between the first and second In2B8 scan residence times.|At week 12||||||
699582|NCT00012298|Secondary|Association Between In2B8 Scan and Positron Emission Tomography Scan Results (Phase I)|Explored using a contingency table and sensitivity and specificity will be calculated using 90% exact confidence intervals.|At week 12||||||
699583|NCT00012298|Secondary|Association Between the Amounts of Tumor Radiation Indicated by the In2B8 Scan and Tumor Response (Phase I)|Assessed using a correlated logistic regression model and generalized estimating equations (GEE). Covariates such as dose level and use of prophylactic cytokines may also be included in this model. A Wilcoxon test will be used to assess the equality of the distributions of the continuous levels of predicted tumor radiation from the In2B8 scans by response.|At week 12||||||
699584|NCT00012298|Primary|Proportion of Patients Who Receive 2 Sequential Doses of Y2B8 Immunotherapy and Are Progression-free (Phase II)|Estimated by the number of successes divided by the total number of evaluable patients. Exact binomial confidence intervals for the true success proportion will be calculated.|At 3 years|Forty-five patients were registered to Dose Level 6 (39 patients registered to the Phase II portion and 6 patients registered to Dose Level 6 in the Phase I portion). Of the 45 patients, 33 patients received 2 sequential doses of Y2B8 and were evaluable for this endpoint.||percentage of participants||95% Confidence Interval|Number
699585|NCT00012298|Primary|Toxicity of Single-dose Y2B8 Radioimmunotherapy With and Without the Use of Growth Factors (Phase I)|Evaluated using the Common Toxicity Criteria (CTC) version 2.0. This data is presented as the number of patients reporting grade 3 or higher, grade 4 or higher, or grade 5 adverse events regardless of event attribution.|Assessed up to week 24|All patients that were evaluated for adverse events after at least one cycle of treatment were used in this analysis.||participants|||Number
699586|NCT00012298|Primary|Maximum Tolerated Dose (MTD) of Yttrium Y-90 Ibritumomab Tiuxetan (Y2B8) With and Without Filgrastim (G-CSF) and Interleukin-11 (IL-11) (Phase I)|"This study is a series of 3 single-arm phase-I trials designed to determine the maximum tolerated dose (MTD) of a 2-cycle combination regimen containing Rituxan + Y2B8 radioimmunotherapy with and without the use of G-CSF and IL-11. Trial 1 will determine the Y2B8 MTD in the combined regimen without growth factors. Trial 2 will evaluate the combined regimen with growth factors. Trial 3 starts IL-11 earlier (when platelet count drops below 150000) and reduces the dosing interval to twice weekly.
> Dose-limiting toxicity (DLT) is defined as an adverse event in the second cycle attributed to treatment and meeting the following criteria: Grade 4 ANC or platelet decrease for 14 days, or grade 3 for 28 days, or any other grade 3 Non-Heme event.
> If at any time 2 or more patients (of a maximum of 6) at any dose level experience DLT, then the MTD will be defined as the previous dose level during that trial. The number of patients with a DLT are reported here."|At 8 weeks|DLTs were determined in the second cycle of combined treatment. Only Phase I patients that were evaluated after 2 cycles of treatment are included in this evaluation. Two patients at Dose Level 1, 1 patient at Dose Level 2, 4 patients at Dose Level 3, and 1 patient at Dose Level 5 were not evaluated for MTD.||Patients reporting Dose-Limiting Events|||Number
699587|NCT00006110|Secondary|Disease-free Survival (DFS) in Patients Receiving and Not Receiving Herceptin®.|Percent of patients receiving and not receiving Herceptin who are alive and disease-free at 5 years.|5 years|||percentage of patients|||Number
699588|NCT00006110|Secondary|Overall Response|Measured by the Overall Response. Response: Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|78 weeks (1.5 years)|Protocol specifies that Response will be examined in patients who were treated neoadjuvantly. Because of this, only patients treated with Herceptin neoadjuvantly and non-Herceptin patients were included in this analysis. One patient was found unevaluable in the AC-P group and was not included in the analysis.||Participants|||Count of Participants
699589|NCT00006110|Primary|Cardiac Toxicity of Weekly Taxol Given With Weekly Herceptin When Delivered Immediately Following Four Cycles of Standard Dose AC.|Doxorubicin + cyclophosphamide in combination with paclitaxel and trastuzumab (AC-TP) Associated Systolic Dysfunction. Systolic function was measured by the ventricular ejection fraction (LVEF). LVEF is a measurement in determining how well your heart is pumping out blood and in diagnosing and tracking heart failure.|78 weeks (1.5 years)|LVEF data during AC-TP are complete on 50 patients. 2 are incomplete because of withdrawal (1) and progressive disease (1). 43 of the 52 patients underwent LVEF determination at 1.5 years.||Participants|||Count of Participants
699590|NCT00006237|Secondary|Toxicity|Number of patients with Grade 3-5 adverse events that are related to study drug by given type of adverse event|While on treatment, patients on the HDIFN arm were assessed weekly for the 1st month, then every 2 weeks for the 2nd month, then every 3 months therafter; patients on the biochemo arm were assessed daily for the 1st 5 days, then weekly thereafter.|Eligible patients who started therapy||Participants|||Number
699591|NCT00006237|Primary|5-year Relapse-Free Survival|Measured from date of registration to date of first observation of progressive disease or death due to any cause.|Every three months for the first year, every 6 months for years 2-5, annually for years 6-10|||Percentage of population|||Number
699592|NCT00006237|Primary|5-year Overall Survival|Overall survival was measured from the date of registration to study until death from any cause with observations censored at the date of last contact for patients last known to be alive.|Every three months for a year, every six months for years 2-5, annual for years 5-10|||Percent of population|||Number
699593|NCT00006244|Secondary|Number of Patients ≥56 Years Old Experiencing Grade 3-4 Regimen Related Toxicity|Grade 3-4 toxicities by the Bearman common toxicity criteria, encountered by older (≥56 years old) advanced multiple myeloma patients treated with melphalan, IL2-incubated peripheral blood stem cells, and sequential IL2.|First 100 days post-transplant|Of the 36 patients, 16 patients were ≥56 years old and these 16 are used to determine this outcome measure.||Participants|||Count of Participants
699594|NCT00006244|Secondary|Number of Patients <56 Years Old Experiencing Grade 3-4 Regimen Related Toxicity|Grade 3-4 toxicities by the Bearman common toxicity criteria, encountered by younger (< 56 years old) advanced multiple myeloma patients treated with melphalan, IL2-incubated peripheral blood stem cells, and sequential IL2.|First 100 days post-transplant|Of the 36 patients, 20 patients were <56 years old and these 20 patients are used to determine this outcome measure.||Participants|||Count of Participants
699595|NCT00006244|Primary|Proportion of Patients Alive and in Remission||12.9 Median Years|||Participants|||Count of Participants
699596|NCT00006244|Primary|Time to Disease Progression||12.9 years (median)|Out of 36 patients, 30 have relapsed and they are used to determine this outcome measure.||years||Full Range|Median
699597|NCT00006244|Primary|Initial Response to Therapy|Evaluate initial response to therapy (complete remission, partial remission, stable response, or progression of disease)|Evaluated at Day +84-90 Post-Transplant|||Participants|||Count of Participants
699598|NCT00006244|Primary|Overall Survival|Overall survival in Multiple Myeloma patients treated with melphalan, IL2-incubated peripheral blood stem cells, and sequential IL2 and interferon maintenance.|12.9 Median Years|||Participants|||Count of Participants
699599|NCT00006289|Primary|McGill Pain Questionnaire (MPQ) of Scores After Administration of Test Drugs (Neurotropin or Placebo)|"Assessments of pain severity by the patient using a McGill Pain Questionnaire which consists of 3 major classes of word descriptors-sensory, affective and evaluative - that are used by patients to specify subjective pain experience. Each word chosen from descriptor responses to 20 questions is given a value and the sum of the values of the responses provides a score which is an index of the pain severity with a minimum value of 20 and a maximal value of 78. When it is difficult to recruit the patients, the interim analysis using these data is performed after completion of the study of first 16 patients (target number is 30). The data from 16 patients was analyzed while investigators are blinded to the treatment code (drug A or B) provided by the NIH pharmacy. Only after the analysis was completed was the code unblinded. Placebo or Neurotropin in place of drug A or drug B."|MPQ of each patient is measured after each five-week treatment interval with drug A or drug B.|||units on a scale||Standard Error|Mean
699600|NCT00006289|Primary|Numeric Rating Scale (NRS) of Pain Scores After Administration of Test Drugs (Neurotropin or Placebo)|"Assessments of pain severity by the patient using a numeric rating scale ranging from 0 to 10 as a verbal response where 0 = no pain and 10 =maximal pain. When it is difficult to recruit the patients, the interim analysis using these data is performed after completion of the study of first 16 patients (target number is 30). The data from 16 patients was analyzed while the investigators are blinded to the treatment code (Drug A or B) provided by the NIH pharmacy. Only after the analysis was completed was the code unblinded. Placebo or Neurotropin in place of drug A or drug B."|NRS of each patient is measured after each five-week treatment interval with placebo or Neurotropin.|||units on a scale||Standard Deviation|Mean
699601|NCT00006289|Primary|Visual Analogue Scale (VAS) of Pain Scores After Administration of Test Drugs (Placebo or Neurotropin )|"Assessments of pain severity by the patient using a visual analogue scale ranging from 0 to 100 (mm), with 0 = no pain and 100 = maximal pain level. When it is difficult to recruit the patients, the interim analysis using these data is performed after completion of the study of first 16 patients (target number is 30). The data from 16 patients was analyzed while investigators were blinded to the treatment code (Drug A and B) provided by the NIH pharmacy. Only after the analysis was completed was the code unblinded. Placebo or Neurotropin in place of drug A or drug B."|VAS of each patient is measured after each 5-week treatment interval with placebo or Neurotropin.|||mm||Standard Error|Mean
699602|NCT00006305|Secondary|Number of Participants With Death, Myocardial Infarction, or Stroke||five years|Intention to treat analysis (ITT) of the two main effects in the 2x2 factorial design, 1) Revascularization versus Medical Therapy and 2) Insulin Sensitizing (IS) versus Insulin Providing (IP)||participants|||Number
699603|NCT00006305|Primary|Number of Participants With All-Cause Mortality||five years|Intention to treat analysis (ITT) of the two main effects in the 2x2 factorial design, 1) Revascularization versus Medical Therapy and 2) Insulin Sensitizing (IS) versus Insulin Providing (IP)||participants|||Number
699604|NCT00006389|Secondary|Progression-free Survival|Progression-free survival was estimated according to the Kaplan-Meier product-limit method|18 months|||months||95% Confidence Interval|Median
699605|NCT00006389|Secondary|Overall Survival|Overall survival was estimated according to the Kaplan-Meier product-limit method.|18 months|||Months||95% Confidence Interval|Median
699616|NCT00014560|Primary|Clinical Toxicity|This study was prematurely ended by the sponsor Medarex (supplier of BsAb) due to toxicities experienced at other sites on unrelated trials leading to the decision that Medarex would not be manufacturing the investigational product (BsAb).|day 1-29|This study was prematurely ended by the sponsor Medarex (supplier of BsAb) due to toxicities experienced at other sites on unrelated trials leading to the decision that Medarex would not be manufacturing the investigational product (BsAb).|||||
725193|NCT00351273|Secondary|Disease Activity Score 44 (DAS44): Ritchie Articular Index (Tender Joint Count), Swollen Joint Count (Out of 44 Joints), ESR, Patient Global Assessment (Visual Analog Scale)||Months 6 and 9||||||
699606|NCT00006389|Primary|Observed Response Rate.|"All patients had measurable disease and were assessed after 2 cycles of chemotherapy by medical photograph, plain x-ray, CT, MRI or other imaging scans of at least 2.0 cm or greater with conventional techniques or 1.0 cm or greater with spiral CT. Patients were evaluated by RECIST criteria. All measurable lesions, up to 10 “target lesions” were recorded and measured at baseline across the longest diameter (LD). All other non-target lesions were documented as present or absent. Complete Response (CR) was defined as complete disappearance of the tumor, partial response (PR) was defined as at least a 30% decrease of the sum of the LD of the target lesions, using the baseline sum LD as the reference
The observed response rate was defined as the percentage of evaluable patients whose best response is a CR or PR with associated 95% confidence interval."|Best response recorded from the start of treatment until disease progression/recurrence. Assessed every 2 cycles.|The first 15 patients accrued to an Optimal Three-Stage Phase II design. If 3 or more responses are seen then 18 additional evaluable patients will be accrued to the second stage.||Percentage of Participants||95% Confidence Interval|Number
699607|NCT00006392|Secondary|Number of Participants With Serious Cardiovascular Events|Participants are seen at the study site every six month for an update of medical events. If the participant has been diagnosed with prostate cancer, study site visits are once a year. Cardiovascular events are based on self-report and are not confirmed. Follow-up was planned for seven to 12 years depending on when the participant was randomized.|Participants are assessed for medical every six months for 7 to 12 years depending on when he was randomized . Upon diagnosis of prostate cancer, updates are annual.|All randomized eligible participants excluding all men from 2 study sites that the DSMC said to exclude due to poor participant/data management and regulatory issues.||participants|||Number
699608|NCT00006392|Secondary|Prostate Cancer Free Survival; Lung Cancer-free Survival, Colorectal Cancer-free Survival, Cancer-free Survival, Overall Survival|Participants are seen at the study site every six month for an update of medical events. If the participant has been diagnosed with prostate cancer, study site visits are once a year. Prostate cancer diagnosis is based on participant report followed by the submission of a pathologic sample to central pathology review for confirmation. Other cancer diagnoses are based on participant report. Medical records for non-prostate cancers were collected but they were not pathologically confirmed. Follow-up was planned for seven to 12 years depending on when the participant was randomized.|Participants are assessed for medical every six months for 7 to 12 years depending on when he was randomized . Upon diagnosis of prostate cancer, updates are annual.|All randomized eligible participants excluding all men from 2 study sites that the DSMC said to exclude due to poor participant/data management and regulatory issues. Deaths include those reported as SAEs as well as non-SAE deaths as this was a prevention trial with older generally healthy men at baseline who were followed for a long time.||participants|||Number
699609|NCT00006392|Secondary|Number of Participants With Any Diagnosis of Cancer|Participants are seen at the study site every six month for an update of medical events. Cancer diagnoses are based on participant report. Medical records for non-prostate cancers were collected but they were not pathologically confirmed. If the participant has been diagnosed with prostate cancer, study site visits are once a year. Follow-up was planned for seven to 12 years depending on when the participant was randomized.|Participants are assessed for medical every six months for 7 to 12 years depending on when he was randomized . Upon diagnosis of prostate cancer, updates are annual.|All randomized eligible participants excluding all men from 2 study sites that the DSMC said to exclude due to poor participant/data management and regulatory issues.||participants|||Number
699610|NCT00006392|Secondary|Number of Participants With Colorectal Cancer|Participants are seen at the study site every six month for an update of medical events. Cancer diagnoses are based on participant report. Medical records for non-prostate cancers were collected but they were not pathologically confirmed. If the participant has been diagnosed with prostate cancer, study site visits are once a year. Follow-up was planned for seven to 12 years depending on when the participant was randomized.|Participants are assessed for medical every six months for 7 to 12 years depending on when he was randomized . Upon diagnosis of prostate cancer, updates are annual.|All randomized eligible participants excluding all men from 2 study sites that the DSMC said to exclude due to poor participant/data management and regulatory issues.||participants|||Number
699611|NCT00006392|Secondary|Number of Participants With Lung Cancer|Participants are seen at the study site every six month for an update of medical events. Cancer diagnoses are based on participant report. Medical records for non-prostate cancers were collected but they were not pathologically confirmed. If the participant has been diagnosed with prostate cancer, study site visits are once a year. Follow-up was planned for seven to 12 years depending on when the participant was randomized.|Participants are assessed for medical every six months for 7 to 12 years depending on when he was randomized . Upon diagnosis of prostate cancer, updates are annual.|All randomized eligible participants excluding all men from 2 study sites that the DSMC said to exclude due to poor participant/data management and regulatory issues.||participants|||Number
699612|NCT00006392|Primary|Number of Participants With Prostate Cancer|Participants are seen at the study site every six month for an update of medical events. Prostate cancer diagnosis is based on participant report followed by the submission of a pathologic sample to central pathology review for confirmation.|Every six months for 7 to 12 years depending on when the participant was randomized.|All randomized eligible men not at 2 sites for which the DSMC said the data could not be used due to participant and data management issues as well as regulatory problems.||participants|||Number
699613|NCT00014495|Primary|Maximum Tolerated Dose|The maximum tolerated dose of bismuth Bi 213 monoclonal antibody M195 following cytarabine in patients with advanced myeloid malignancies.|2 years|||mCi/kg|||Number
699614|NCT00014560|Secondary|Serum Markers of Macrophage Activation|This study was prematurely ended by the sponsor Medarex (supplier of BsAb) due to toxicities experienced at other sites on unrelated trials leading to the decision that Medarex would not be manufacturing the investigational product (BsAb).|Day 1 Hours 0,2,4,6,24, day 15 Hours 0,2,4,6,24||||||
699615|NCT00014560|Primary|Determine the Maximum Tolerated Dose (MTD) and Dose Limiting Toxicity (DLT) of BsAb 4G7 x 22|This study was prematurely ended by the sponsor Medarex (supplier of BsAb) due to toxicities experienced at other sites on unrelated trials leading to the decision that Medarex would not be manufacturing the investigational product (BsAb).|Day 1-29||||||
705916|NCT00113087|Secondary|MacArthur-Bates Inventory -Phrases Understood|MacArthur-Bates Communicative Development inventory( Words and Gestures)-Phrases Understood z-score.|at 14 months of age|ITT, no imputation||standard deviation||Standard Deviation|Mean
699617|NCT00014911|Post-Hoc|Serum Creatinine Levels for Participants in the Extended Follow-up Study Phase|Seven participants from US sites were included in the extended follow-up. These participants were monitored yearly from year three post last transplantation (the original end of study follow-up) through August 30, 2010 (up to 9 years post first transplantation), at which point they were transferred to a new protocol (ITN040CT [NCT01309022]). Serum creatinine is a measure of renal function. Normal ranges are from 0.5 to 1.0 mg/dL for females and 0.7 to 1.2 mg/dL for males.|First transplantation through August 30, 2010 (up to 9 years)|Intent-to-Treat||mg/dL||Full Range|Mean
699618|NCT00014911|Post-Hoc|HbA1c Plasma Laboratory Values for Participants in the Extended Follow-up Study Phase|Seven participants from US sites were included in the extended follow-up. These participants were monitored yearly from year three post last transplantation (the original end of study follow-up) through August 30, 2010 (up to 9 years post first transplantation), at which point they were transferred to a new protocol (ITN040CT [NCT01309022]). Glycosylated hemoglobin (HbA1c) is a measure of the average plasma glucose concentration over prolonged periods of time. (Normal:<5.7%; pre-diabetes: 5.7% -6.4%; diabetes: 6.5% or higher)|First transplantation through August 30, 2010 (up to 9 years)|Intent-to-Treat||HbA1c Percentage||Full Range|Mean
699619|NCT00014911|Secondary|Percent of Participants With Detectable Fasting Basal C-Peptide Levels|C-peptide is a substance that the pancreas releases into the bloodstream in equal amounts to insulin, thereby showing how much insulin the body is making. C-peptide secretion is used to measure the function of transplanted islets. Higher levels indicate better islet function. Detectable fasting basal levels of C-peptide secretion are >=0.3 ng/ml.|Two years post first transplantation|Intent-to-Treat||Percent of Participants|||Number
699620|NCT00014911|Secondary|Percent of Participants That Achieved Insulin Independence From First Transplant|Insulin independence: exogenous insulin not required and glycemic control is achieved as defined by maintaining 1) a blood glycosylated hemoglobin (HbA1c) level < 6.5% (Normal:<5.7%; pre-diabetes: 5.7% -6.4%; diabetes: 6.5% or higher),2) a blood glucose level after an overnight fast not exceeding 140 mg per deciliter (dL) more than three times in any week (Normal: 70 to 120 mg/dL), and 3)not exceeding a 2-hour postprandial blood glucose level of 180 mg/dL more than four times per week (Normal: <140mg/dL if <=50 years of age, <150 mg/dL for ages 50-60 years and <160 mg/dL for ages 60+)|First transplantation until end of study (up to six years post final transplantation)|Intent-to-Treat||Percent of Participants|||Number
699621|NCT00014911|Secondary|Percent of Participants With Partial Islet Function One Year Post Final Islet Transplantation.|Partial islet function definition: a fasting basal C-peptide level >= 0.3 ng/mL and a continuing need for insulin or suboptimal glycemic control (Note: C-peptide is a substance that the pancreas releases into the bloodstream in equal amounts to insulin, thereby showing how much insulin the body is making). Adequate glycemic control is defined by: 1) a blood HbA1c level <6.5%, 2) a blood glucose level after an overnight fast not exceeding 140 mg/dL more than three times in any week and, 3) a 2-hour postprandial blood glucose level not exceeding 180 mg/dL more than four times per week|One year post receipt of final islet transplantation|Intent-to-treat||Percent of Participants|||Number
699622|NCT00014911|Primary|Percent of Participants That Achieved Insulin Independence With Adequate Control of Blood Glucose Levels at One Year Post Final Islet Transplantation.|Insulin independence: exogenous insulin not required and glycemic control is achieved as defined by maintaining 1.) a blood glycosylated hemoglobin (HbA1c) level < 6.5% (Normal:<5.7%; pre-diabetes: 5.7% -6.4%; diabetes: 6.5% or higher),2) a blood glucose level after an overnight fast not exceeding 140 mg per deciliter (dL) more than three times in any week (Normal: 70 to 120 mg/dL), and 3)not exceeding a 2-hour postprandial blood glucose level of 180 mg/dL more than four times per week (Normal: <140mg/dL if <=50 years of age, <150 mg/dL for ages 50-60 years and <160 mg/dL for ages 60+)|One year status post participant receipt of final islet transplantation|Intent-to-treat||Percent of Participants|||Number
699623|NCT00015457|Secondary|Duration of Response to Botulinum Toxin Injection With Amlodipine and With Placebo|Self reported duration of effect in weeks.|3 months|Total enrolled less withdrawals. Less one participant who completed the study but who did not yield analyzeable data.||weeks||Full Range|Median
699624|NCT00015457|Primary|Toronto Western Spasmodic Torticollis Rating Scale (TWSTR) Sum Score|Rating scale assessing sum of severity of dystonia, disability score and pain scale. Ordinal scale ranging from 0 (least severe) to 30 (maximally severe). Score is maximal response TWSTR rating minus baseline rating.|1-2 month maximal rating|Total enrolled less withdrawals from study. One participant completed the study but did not yield analyzeable data||units on a scale||Standard Deviation|Mean
699625|NCT00015847|Primary|Major Cytogenetic Response After 6 and 12 Months of Treatment.|"Cytogenetic response in terms of the percentage of Ph chromosome positive metaphases in bone marrow is defined as follows:
Complete* (0% Ph-positive cells) Partial* (1-34%) Minor (35-95%) None (96-100%).
*Major cytogenetic response includes complete and partial cytogenetic response."|6 and 12 months after treatment|||Participants|||Number
699626|NCT00015847|Primary|Treatment-related Toxicity (i.e., Grade 3 or 4 Nonhematologic Toxicity) as Measured by NCI CTCAE v3.0 (Phase I)|1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death|12 Months|||Participants|||Number
699627|NCT00015847|Primary|Molecular Response in Patients With Complete Cytogenetic Response at 6 and 12 Months (Phase II)||At 6 and 12 months during phase II||||||
699628|NCT00015847|Primary|Complete Hematologic Response at 6 and 12 Months (Phase II)||At 6 and 12 months during phase II||||||
699629|NCT00015847|Primary|Minor Cytogenetic Response at 6 and 12 Months (Phase II)||At 6 and 12 months during phase II||||||
699630|NCT00015847|Primary|Complete Cytogenetic Response at 6 and 12 Months (Phase II)|"Cytogenetic response in terms of the percentage of Ph chromosome positive metaphases in bone marrow is defined as follows:
Complete* (0% Ph-positive cells) Partial* (1-34%) Minor (35-95%) None (96-100%)."|At 6 and 12 months during phase II|||Participants|||Number
699631|NCT00016354|Secondary|Test for Antitumor Activity in Blood and Tissue||baseline||||||
699632|NCT00016354|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC) of BPU||8 weeks||||||
699633|NCT00016354|Secondary|Number of Patients With Adverse Events||every 4 weeks||||||
699700|NCT00021255|Secondary|Overall Survival- Percentage of Participants Who Survived at 10 Years|Overall survival of the participants was measured from the date of randomization up to the date of death due to any cause. Overall survival was estimated using the Kaplan-Meier method.|From randomization until death or up to 10 years|ITT population.||percentage of particpants||95% Confidence Interval|Number
699634|NCT00016354|Primary|Determine Maximum Tolerated Dose of BPU|Toxicity was assessed weekly during the first 2 cycles, and monthly thereafter, using the National Cancer Institute Common Toxicity Criteria (NCI CTCv2). Dose limiting toxicity (DLT) was defined as dose delays >2 weeks, grade 4 haematologic toxicity (except grade 4 neutropenia lasting <5 days), or grade 3 nonhaematologic toxicity. The maximum tolerated dose (MTD) is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience a dose-limiting toxicity.|4 weeks (1 course of treatment for each subject)|Participants that completed at least 1 cycle of BPU.||milligrams (mg)|||Number
699635|NCT00006151|Primary|Abstinence Rate|The main outcome measures were rates of treatment completion and smoking abstinence. It was hypothesized that the nicotine blocking agent product would lead to higher treatment completion rates, higher abstinence rates, and fewer problems with withdrawal than the placebo group.|1 year|||participants|||Number
699636|NCT00006156|Secondary|Follicle Stimulating Hormone Stimulated Serum Estradiol (E2) Levels||24 hours|||participants||Standard Error|Mean
699637|NCT00006156|Primary|Follicle Stimulating Hormone Stimulated Serum Inhibin B Levels.||24 hours|||participants||Standard Error|Mean
699638|NCT00006164|Primary|Hepatic Encephalopathy|Any mental status alteration which is deemed by the investigator to be due to portosystemic encephalopathy, whether occurring during a provoked episode (GI bleeding, diuretics, usual sedative doses), or spontaneously (without apparent cause).|1400 days (3.85 years) post randomization|||participants|||Number
699639|NCT00006164|Secondary|Quality of Life|To measure health-related quality of life (HRQOL), we administered the highly reliable and validated Short Form Health Survey (SF-36) 43 at annual study visits.|1400 days (3.85 years) post randomization||10/2010||||
699640|NCT00006164|Secondary|Presumed Hepatocellular Carcinoma (HCC)|"Presumed HCC was considered when histology was not available and alpha-fetoprotein (AFP) is <1000 ng/ml, if:
A new hepatic lesion was shown on ultrasound and 1 additional imaging showed a hepatic lesion with characteristics of HCC.
AFP>ULN (upper limit of normal) and 2 imaging studies showed a hepatic lesion with characteristics of HCC.
A progressively enlarging hepatic lesion starting as a new defect resulting in patient death.
A new hepatic defect with at least 1 characteristic scan and:
Increase in size over time or
Increasing AFP rising to a level of >200 ng/ml"|1400 days (3.85 years) post randomization||10/2010||||
699641|NCT00006164|Secondary|Changes in Fibrosis From Baseline at Year 2 or Year 4 Biopsy.|For patients with noncirrhotic fibrosis at baseline, any change in Ishak hepatic fibrosis score (range 0-6, higher score indicates greater fibrosis) of at least 2 points by assessment of a liver-biopsy specimen obtained during the study (collected at Year 2 and Year 4 biopsies, 1.5 and 3.5 years after randomization)|1400 days (3.85 years) post randomization||10/2010||||
699642|NCT00006164|Secondary|Events Requiring Dose Reductions (in Both Treatment Groups).|"Reduction in the dose of peginterferon alfa-2a factors:
Disabling symptoms, which, in the opinion of the investigator, were related to peginterferon alfa-2a treatment and prevented the patient from performing his/her occupation or daily tasks.
A rash consistent with allergic reaction or vasculitis.
Reductions in the platelet count according to protocol guidelines.
A reduction in neutrophil count according to protocol guidelines.
Any adverse reaction, which, in the opinion of the investigator, placed the patient at increased risk."|1400 days (3.85 years) post randomization||10/2010||||
699643|NCT00006164|Secondary|Serious Adverse Events|"A serious adverse event (SAE) is an untoward medical occurrence that results in any of the following:
Death
Is life threatening (risk of death at the time of the event)
Requires in-patient hospitalization or prolongation of existing hospitalization
Results in persistent or significant disability/incapacity
Congenital abnormality or birth defect
Trial outcomes (except death) were not considered serious adverse events."|1400 days (3.85 years) post randomization|||participants|||Number
699644|NCT00006164|Primary|Spontaneous Bacterial Peritonitis|Any episode of spontaneous ascitic infection diagnosed on the basis of elevated neutrophil count (> 250/ml) in paracentesis fluid or positive bacterial cultures and clinical diagnosis in the absence of white blood cell (WBC) availability.|1400 days (3.85 years) post randomization|||participants|||Number
699645|NCT00006164|Primary|Ascites|"Any abdominal fluid which is:
Mild, moderate or marked on ultrasound; or
Progressive on serial physical examinations; or
Requires diuretic therapy. To meet the definition of ascites, abdominal fluid that is “mild” (“barely detectable”) on physical examination requires ultrasound confirmation that is “mild”, “moderate” or “marked” ascites. Ultrasound reports of minimal fluid around the liver do not meet the definition."|1400 days (3.85 years) post randomization|||participants|||Number
699646|NCT00006164|Primary|Variceal Hemorrhage|A gastrointestinal hemorrhage which is believed by the investigator to be due to bleeding esophageal or gastric varices. In general, an endoscopy will have been performed and will have revealed either direct evidence of variceal bleeding (bleeding varix, red wale sign) or historical evidence for significant upper gastro-intestinal bleeding plus upper endoscopy revealing moderate varices and no other site of bleeding is identified|1400 days (3.85 years) post randomization|||participants|||Number
699647|NCT00006164|Primary|Child-Turcotte-Pugh (CTP) Score of 7 or Higher at Two Consecutive Study Visits|Child-Turcotte-Pugh (CTP) score of 7 or more on two consecutive study visits (score range 5-15, higher score indicates greater hepatic decompensation)|1400 days (3.85 years) post randomization|||participants|||Number
699648|NCT00006164|Primary|Development of Hepatocellular Carcinoma (HCC)|"A diagnosis of development of hepatocellular carcinoma (HCC) was based on either
Histology showing HCC (from a biopsy, surgery, or autopsy) or
A new hepatic defect on imaging with an alpha-fetoproteion (AFP) level rising to > 1,000 ng/ml."|1400 days (3.85 years) post randomization|||participants|||Number
699649|NCT00006164|Primary|Death From Any Cause||1400 days (3.85 years) post randomization|||participants|||Number
699650|NCT00006164|Primary|Increase in Ishak Fibrosis Score by 2 Points or More at 2 or 4 Year Biopsies|For patients with noncirrhotic fibrosis at baseline, an increase in Ishak hepatic fibrosis score (range 0-6, higher score indicates greater fibrosis) of at least 2 points by assessment of a liver-biopsy specimen obtained during the study (collected at Year 2 and Year 4 biopsies, 1.5 and 3.5 years after randomization)|1400 days (3.85 years) post randomization|||participants|||Number
699749|NCT00022763|Secondary|Number of Participants Who Prematurely Withdrew Due to AE||Up to Week 96|Safety Analysis Population: All participants who received at least one dose of study medication were included.||participants|||Number
699750|NCT00022763|Secondary|Number of Participants Who Died||Up to Week 96|Safety Analysis Population: All participants who received at least one dose of study medication were included.||participants|||Number
699651|NCT00006164|Primary|Progression of Liver Disease as Indicated by Death, Hepatic Decompensation, Hepatocellular Carcinoma, or for Patients With Noncirrhotic Fibrosis at Baseline, an Increase in the Ishak Hepatic Fibrosis Score of 2 or More Points|Progression of liver disease within 1400 days as indicated by death, hepatic decompensation (variceal hemorrhage; ascites; spontaneous bacterial peritonitis; hepatic encephalopathy), hepatocellular carcinoma, a Child-Turcotte-Pugh (CTP) score of 7 or more on two consecutive study visits (score range 5-15, higher score indicates greater decompensation), or for patients with noncirrhotic fibrosis at baseline, an increase in Ishak hepatic fibrosis score (range 0-6, higher score indicates greater fibrosis) of at least 2 points by assessment of a liver-biopsy specimen obtained during the study|1400 days (3.85 years) post randomization|||participants|||Number
699652|NCT00006170|Primary|Smoking Abstinence|Women were interviewed using the time-line follow-back method and expired-air carbon monoxide (CO) was collected using a Vitalograph BreathCO monitor. Salivary samples were collected immediately after each assessment visit (1, 3, 6, and 12 mo). A CO reading of 8ppm or less and cotinine level of >15 micrograms/L were used to confirm non-smoking.|12 months|Participants with available data at 12mo. All others were unable to provide data at this time point.||percentage of participants|||Number
699653|NCT00006170|Primary|Smoking Abstinence|Women were interviewed using the time-line follow-back method and expired-air carbon monoxide (CO) was collected using a Vitalograph BreathCO monitor. Salivary samples were collected immediately after each assessment visit (1, 3, 6, and 12 mo). A CO reading of 8ppm or less and cotinine level of >15 micrograms/L were used to confirm non-smoking.|6 months|Participants with available data at 6mo. All others were unable to provide data at this time point.||percentage of participants|||Number
699654|NCT00006170|Primary|Smoking Abstinence|Women were interviewed using the time-line follow-back method and expired-air carbon monoxide (CO) was collected using a Vitalograph BreathCO monitor. Salivary samples were collected immediately after each assessment visit (1, 3, 6, and 12 mo). A CO reading of 8ppm or less and cotinine level of >15 micrograms/L were used to confirm non-smoking.|3 months|Participants with available data at 3mo. All others were unable to provide data at this time point.||percentage of participants|||Number
699655|NCT00006178|Secondary|Glomerular Filtration Rate (Flow Rate of Filtered Fluid Through the Kidney)|measure at 12 months after intervention|12 months after intervention|||mL/min||Standard Deviation|Mean
699656|NCT00006178|Primary|Serum Creatinine Concentration|measures at 12 months after intervention|12 months after intervention|||umol/L||Standard Deviation|Mean
699657|NCT00006178|Primary|Serum Creatinine Concentration|measures at 6 months after intervention|6 months after intervention|Analysis includes all participants in the study. Analysis was per protocol.||umol/L||Standard Deviation|Mean
699658|NCT00006178|Secondary|Glomerular Filtration Rate (Flow Rate of Filtered Fluid Through the Kidney)|measure 6 months after intervention|6 month after intervention|||mL/min||Standard Deviation|Mean
699661|NCT00008138|Primary|Progression-Free Survival|Progression was defined as a CA-125 value that is both twice the nadir since registration and greater than 70 units/ml, and is confirmed by a second determination at least 7 days apart, or appearance of any new lesion/site. Symptomatic deterioration was defined as a global deterioration of health status requiring removal from protocol treatment. Progression-Free Survival was defined as the time from the date of registration to the date of progression, symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free were censored at last contact date.|Monthly during protocol treatment, then every 3 months up to the end of Year 1, then every 6 months for the next two years, then annually up to Year 5.|Only eligible patients were included in the analysis.||months||95% Confidence Interval|Median
699662|NCT00008138|Primary|Overall Survival|Overall survival was defined as the time from the date of registration until the date of death due to any cause. Patients last known to be alive were censored at the date of last contact. Patients were followed every 3 months for the first year, every 6 months for years 2 and 3, and then annually for years 4 and 5.|assessed every 3 months for 1st year, then every 6 months for 2 years, then annually for years 4 and 5|Only eligible patients were included in the analysis.||months||95% Confidence Interval|Median
699663|NCT00008385|Secondary|5-year Overall Survival Rate|Overall survival (OS) was defined as the time from randomization to death due to any cause. Cases without death had been censored at the time of last known alive. Kaplan-Meier method was used to estimate 5-year OS rate.|Assessed annually for 5 years after randomization|All randomized patients||proportion of participants||95% Confidence Interval|Number
699664|NCT00008385|Secondary|5-year Progression-free Survival Rate|"Progression-Free Survival (PFS) was defined as the time from randomization to second primary lung cancer or recurrence. Cases without events have been censored at the time of last known alive. Kaplan-Meier method was used to estimate 5-year PFS rate.
Accurate determination of whether a cancer occurrence is recurrence or whether it is a second primary is critical. All suspicious lesions identified clinically and/or radiographically were verified histologically. Patients with at least one of the following is considered as having second primary lung cancer.
Different histologic type
Location in different lobe
Location in contralateral lung
Occurrence > 5 years after initial diagnosis"|Assessed annually for 5 years after randomization|All randomized patients||proportion of participants||95% Confidence Interval|Number
699665|NCT00008385|Primary|Incidence Rate of Second Primary Lung Tumor|Incidence rate of second primary lung tumor was defined as the number of new second primary lung tumors per 100 population at risk in a year.|Assessed annually for 10 years after randomization|all randomized patients||cases/100 person years|||Number
699801|NCT00023595|Secondary|H01: KCCQ Overall Summary Score|This score represents the mean of these 4 scores: Physical Limitation, Total Symptom, Quality of Life, and Social Limitation. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.||units on a scale||Standard Deviation|Mean
699666|NCT00009737|Secondary|Number of Participants With Any Adverse Events and Serious Adverse Events|An Adverse Event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An Serious Adverse Events (SAEs) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.|Up to Week 29|The safety population comprises all participants who received at least one dose of capecitabine, 5-fluorouracil, or leucovorin and had at least one post baseline safety assessment||Participants|||Number
699667|NCT00009737|Secondary|Number of Participants With Abnormalities for Blood Chemistry and Hematological Parameters|Laboratory abnormalities were categorized according to the National Cancer Institute of Canada Common Toxicity Criteria (NCIC - CTC) grading system (May 1991 revised) as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (life- threatening). Participants with abnormalities in hemoglobin, granulocytes, lymphocytes, neutrophils, neutrophils/granulocytes, platelets, white blood cell, potassium, serum creatinine, sodium, total bilirubin, alanine transaminase, aspartate aminotransferase, alkaline phosphatase, calcium (hyper), and calcium (hypo) with Grades 1-4 were presented.|Up to Week 25|The safety population comprises all participants who received at least one dose of capecitabine, 5-fluorouracil, or leucovorin and had at least one post baseline safety assessment.||Participants|||Number
699668|NCT00009737|Secondary|Mean Change From Baseline in Global Health Status at Week 25|Global health status was assessed as a sub scale of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30. It was scored on a scale of 0-100; where higher score indicates better quality of life. Wherever the scores for the participants were not available, the last value carried forward (LVCF) were used.|Baseline (Days -7 to 1) and at Week 25|The safety population included all participants who received at least one dose of capecitabine, 5-fluorouracil, or leucovorin and had at least one post baseline safety assessment (adverse events, laboratory test results, or vital signs).||Score on a scale||Standard Error|Mean
699669|NCT00009737|Secondary|Overall Survival|Participants with overall survival were reported. Overall survival was assessed as the number of days between randomization and death or the last time at which a participant was known to be alive (censoring time).|Approximately 3 years|All randomized population included all participants who were randomized to one of the two treatment arms, regardless of whether they received any study medication.||Participants|||Number
699670|NCT00009737|Secondary|Relapse-Free Survival|Participants with relapse-free survival were reported. Relapse-free survival was assessed as the number of days between randomization and the first time at which relapse, a new occurrence of colon cancer, or death was recorded, or the last time at which a participants was known to be disease free (censoring time), excluding deaths that were not related to treatment or to disease progression.|Approximately 3 years|All randomized population included all participants who were randomized to one of the two treatment arms, regardless of whether they received any study medication.||Participants|||Number
699671|NCT00009737|Primary|Disease-free Survival|Participants with disease-free survival were reported. Disease-free survival was assessed as the number of days between randomization and the first time at which relapse, a new occurrence of colon cancer, or death was recorded, or the last time at which a participant was known to be disease free (censoring time).|Approximately 3 years|All randomized population included all participants who were randomized to one of the two treatment arms, regardless of whether they received any study medication.||Participants|||Number
699672|NCT00010257|Secondary|Duration of Response|Time from first satisfaction of response criteria to onset of disease progression, assessed using RECIST criteria|assessed every 3 months for 2 years, then every 6 months for 3 years, then annually thereafter|Number of participants achieving a complete or partial response by RECIST criteria||Months||95% Confidence Interval|Median
699673|NCT00010257|Primary|Best Overall Response by RECIST Criteria (Version 1.0)|Number of eligible, treated participants in each response category by RECIST criteria|Assessed every 2 cycles (6 weeks)|Analysis population included all eligible participants who received at least 1 dose of the protocol treatment||Participants|||Number
699674|NCT00016913|Secondary|Progression-free Survival (PFS)|PFS was defined as the time between treatment initiation and the date of disease progression (PSA, bone, tumor) or death, whichever occurred first. PSA progression is defined as 2 consecutive rising PSAs (a rise of at least 0.2 ng/mL) above 1.0 ng/mL.|registration to progression, up to 5.5 years from registration|All 27 evaluable patients were used in this analysis||months||95% Confidence Interval|Median
699675|NCT00016913|Secondary|Time to Prostate-specific Antigen Failure|PSA progression was defined in 2 ways. The CALGB PSA progression was defined as 2 consecutive rises in PSA with a rise of at least 0.2 ng/mL and above 1.0 ng/mL after radiation therapy; the date of PSA failure is taken as the midpoint between the last PSA before the rise and the first of the 2 PSAs that documented the rise. In addition, PSA progression was used according to the American Society for Therapeutic Radiology and Oncology 1996 (ASTRO) criteria and defined as 3 consecutive rises in PSA after radiation therapy. The date of PSA failure was taken as the midpoint between the time of the lowest PSA measure after irradiation and the first of the 3 consecutive rises.|PSA was measured every 4 weeks during chemotherapy, at least every 12 weeks post radiation for 2 years, and every 6 months thereafter until PSA failure date (Up to 5.5 years).|All 27 evaluable patients were used in this analysis.||months||95% Confidence Interval|Median
699676|NCT00016913|Primary|Toxicity|Patients were evaluated for acute toxicities defined as grade 3 or greater cardiovascular (including venous thrombosis), gastrointestinal, or genitourinary toxicity occurring during the period starting from treatment initiation until 90 days or less after the completion of radiotherapy. The same toxicity measures were monitored at >90 days after the completion of radiotherapy.|90 days and 1 year post treatment|Final analyses were performed on all 27 eligible patients.||Events|||Number
699677|NCT00019604|Secondary|Evaluate the Ability of Fludeoxyglucose (18F) Positron-Emission Tomography (FDG-PET) to Monitor Response Following Radiofrequency Ablation (RFA)|PET scan images was to be read by a physician experienced in the interpretation of whole body PET imaging. The region of interest was to be performed in any abnormal sites of uptake that is a candidate and or has been RFA ablated.|Baseline, 6 weeks, 3 months, and 6 months following treatment|This outcome measure was not analyzed because the investigator left the institution and the study never completed; all participants were taken off study.|||||
699678|NCT00019604|Secondary|Compare the Performance of Fludeoxyglucose (18F) Positron-Emission Tomography to Computed Tomography and Magnetic Resonance Imaging With Respect to Their Ability to Assess the Effects of Radiofrequency Ablation on the Treatment of Hepatic Neoplasms|Images obtained by the FDG-PET, MRI and CT was to be processed for changes in measured parameters and quantified compared to baseline (e.g., <median change, >median change in size on CT, computed by subtracting the baseline value from the value at the appropriate follow-up point).|Baseline, 6 weeks, 3 months, and 6 months following treatment|This outcome measure was not analyzed because the investigator left the institution and the study never completed; all participants were taken off study.|||||
699679|NCT00019604|Secondary|Compare Fludeoxyglucose (18F) Positron-Emission Tomography (FDG-PET) Results With Serum Markers|Images obtained by the FDG-PET was to be processed for changes in measured parameters and quantified compared to serum markers at baseline and appropriate follow-up points.|Baseline, 6 weeks, 3 months, and 6 months following treatment|This outcome measure was not analyzed because the investigator left the institution and the study never completed; all participants were taken off study.|||||
699680|NCT00019604|Secondary|Compare Fludeoxyglucose (18F) Positron-Emission Tomography (FDG-PET) Results With Biopsies|Participants were to undergo tissue biopsies of tumor to quantify changes in the tumor to see if the changes we see on the imaging studies are the same as the changes in the tumor.|Baseline, 6 weeks, 3 months, and 6 months following treatment|This outcome measure was not analyzed because the investigator left the institution and the study never completed; all participants were taken off study.|||||
699681|NCT00019604|Secondary|Compare Fludeoxyglucose (18F) Positron-Emission Tomography (FDG-PET) Results With Computed Tomography (CT)|Participants were to undergo FDG-PET scanning and CT scans to compare changes in size of metabolically active volume and standard uptake value (tumor metabolism).|Baseline, 6 weeks, 3 months, and 6 months following treatment|This outcome measure was not analyzed because the investigator left the institution and the study never completed; all participants were taken off study.|||||
699682|NCT00019604|Secondary|Percentage of Participants With a Response Using Fludeoxyglucose (18F) - Positron Emission Tomography (FDG-PET) Following Radiofrequency Ablation (RFA)|Response was to be evaluated by the standard response criteria. Complete response is the complete disappearance of the index lesion on follow-up scan when compared to the pretreatment images. Partial response is a decrease of 50% or greater in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images. Minor response is a decrease between 25% and 49% in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images. Stable disease is no change in the size of the treated lesion. Progressive disease is an increase of greater than 25% in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images.|Baseline, 6 weeks, 3 months, and 6 months following treatment|This outcome measure was not analyzed because the investigator left the institution and the study never completed; all participants were taken off study.|||||
699683|NCT00019604|Secondary|Tumor Vascular Density|Tumor vascular density was to be assessed by magnetic resonance imaging (MRI) and compared to data collected on baseline pretreatment images and other appropriate time points for changes in tumor microvascular density. Patterns of MRI contrast uptake within tumors correlate with microvessel density.|Baseline, 3 months, and 6 months following treatment|This outcome measure was not analyzed because the investigator left the institution and the study never completed; all participants were taken off study.|||||
699684|NCT00019604|Secondary|Tumor Blood Flow|Tumor blood flow was to be assessed by magnetic resonance imaging (MRI) and compared to data collected on baseline pretreatment images and other appropriate time points for changes in tumor microvascular density.|Baseline, 3 months, and 6 months following treatment|This outcome measure was not analyzed because the investigator left the institution and the study never completed; all participants were taken off study.|||||
699685|NCT00019604|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|9 years, 9 months|NA is entered for the total number of participants with adverse events because it is unknown. Adverse event data is available but the format is uninterpretable.||Participants|||Number
699686|NCT00019604|Primary|Response|Standard response criteria will be used to assess the CT (computed tomography) scan images on a lesion per lesion basis. Complete response is complete disappearance of the index lesion on followup scan when compared to the pretreatment images. Partial response is a decrease of 50% or greater in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images. Minor response is a decrease between 25% and 49% in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images. Stable disease is no change in the size of the treated lesion. Progressive disease is an increase of greater than 25% in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images.||The time frame for this outcome measure is unknown; the investigator left the institution and there is no available data. We only have access available on 23 participants. We cannot comment on the others or verify because we do not have the data.||Participants|||Number
699687|NCT00019747|Primary|Time to Progression|Time to progression was measured from the on study date until the date of progression or last follow up. Progression was assessed by the Response Evaluation Criteria for Solid Tumors (RECIST).Progressive Disease (PD)is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions|62 months|The analysis was not done because there were not enough subjects to do any of the statistical analyses.|||||
699688|NCT00020722|Secondary|Overall Survival||Length of time from day of transplant until death.|Trial converted to a proof-of-principle or concept trial; 7 eligible pts received their ATC infusions, 5 were evaluable. This small number of pts is not adequate for progression-free survival or overall survival analysis, collected and analyzed the data for cytotoxicity, IFN-g EliSpots and serum antibodies to monitor for immune responses.|||||
699689|NCT00020722|Primary|Disease-free Survival||Length of time from day of transplant until recurrence or relapse.|Trial converted to a proof-of-principle or concept trial; 7 eligible pts received their ATC infusions, 5 were evaluable. This small number of pts is not adequate for progression-free survival or overall survival analysis, collected and analyzed the data for cytotoxicity, IFN-g EliSpots and serum antibodies to monitor for immune responses.|||||
699690|NCT00021229|Secondary|Pre-treatment Vascular Endothelial Growth Factor Values From Plasma|This study attempted to investigate in an exploratory manner the effect of biological markers on tumor growth. Vascular endothelial growth factor (VEGF) may play a role in tumor development by helping tumor vessels establish and grow. Blood (plasma) was drawn from participants before treatment to measure the baseline plasma VEGF values.|Pre-treatment|Per protocol, the analysis population consists of participants treated on the phase I component who submitted pre-treatment blood samples for the biomarker study.||pg/ml||Standard Error|Mean
699691|NCT00021229|Secondary|Pre-treatment Vascular Endothelial Growth Factor From Urine|This study attempted to investigate in an exploratory manner the effect of biological markers on tumor growth. Vascular endothelial growth factor (VEGF) may play a role in tumor development by helping tumor vessels establish and grow. Urine was collected from participants before treatment to measure the baseline urine VEGF values.|Pre-treatment|Per protocol, the analysis population consists of participants treated on the phase I component who submitted pre-treatment urine samples for the biomarker study.||pg/ml||Standard Deviation|Mean
699692|NCT00021229|Secondary|Pre-treatment Basic Fibroblast Growth Factor Values From Plasma|This study attempted to investigate in an exploratory manner the effect of biological markers on tumor growth. Basic fibroblast growth factor (bFGF) may play a role in tumor development by helping tumor vessels establish and grow. Blood (plasma) was drawn from participants before treatment to measure the baseline plasma bFGF values.|Pre-treatment|Per protocol, the analysis population consists of participants treated on the phase I component who submitted pre-treatment blood samples for the biomarker study.||pg/ml||Standard Deviation|Mean
699693|NCT00021229|Secondary|Pre-treatment Basic Fibroblast Growth Factor Values From Urine|This study attempted to investigate in an exploratory manner the effect of biological markers on tumor growth. Basic fibroblast growth factor (bFGF) may play a role in tumor development by helping tumor vessels establish and grow. Urine was collected from participants before treatment to measure the baseline urine bFGF values.|Pre-treatment|Per protocol, the analysis population consists of participants treated on the phase I component who submitted pre-treatment urine samples for the biomarker study.||pg/ml||Standard Deviation|Mean
699694|NCT00021229|Secondary|Median Overall Survival|Overall Survival (OS) is defined as the interval from initiation of treatment to death or date of last contact for surviving patients.|Assessed before radiation therapy, before the first dose of imatinib, then every 8 weeks.|The analysis population consists of the stratum I participants who received imatinib mesylate at or above the maximum tolerated dose. The median survival reported is based on these 20 participants.||Days||95% Confidence Interval|Median
699695|NCT00021229|Secondary|Peak Concentration (Cmax)|Peak concentration (cmax) is a pharmacokinetic measure defined as the highest concentration of a drug measured after the drug is administered. The cmax of imatinib mesylate on day 1 of course 1 is reported. Two milliliter (0.5 ml for children under the age of 5) blood samples were collected immediately prior to imatinib mesylate administration on Day 1 of Course 1 and at the following timepoints following drug administration: 0.5, 1, 1.5, 2, 4, 10 and 12 hours after the morning dose.|Day 1 of Course 1|The analysis population consists of participants who enrolled at the maximum tolerated dose (MTD) of the phase I component and who submitted day 1 course 1 samples for the PK studies. An MTD was not estimated in stratum IIB. For this stratum, reported are values at the stratum IIA MTD to allow comparison.||µg/ml||Full Range|Mean
699696|NCT00021229|Secondary|Change From Baseline in Volume FLAIR at Two Weeks After Completion of Radiation|This study attempted to investigate in an exploratory manner the effect of radiation (RT) on changes in various neuroimaging variables in pediatric brainstem gliomas (stratum I). Neuroimaging changes may have some association with outcome (response, survival, etc.). Volume FLAIR is one parameter obtained from standard magnetic resonance imaging (MRI) studies of the brain. Volume FLAIR was obtained at baseline (pre-radiation) and within two (+/- one) weeks after completion of RT.|Baseline and two weeks post completion of radiation|The analysis population consists of Stratum I patients enrolled who had both pre and post radiation (RT) volume FLAIR measures. Stratum II participants did not receive RT and thus were not included.||cubic centimeters||Full Range|Mean
699697|NCT00021229|Primary|Median Progression-free Survival (PFS)|Progression-free survival is defined as the interval from initiation of treatment to the earliest of disease progression (tumor increase of 25% over baseline tumor measurement; appearance of new lesion(s); or progressive/worsening neurological status) or death for patients who failed, or to the last date of follow up for patients without failure.|Assessed pre-radiation, before the first dose of imatinib, and then every 8 weeks|Per protocol, 40 participants who received at least one dose of drug were needed for this objective. The analysis population consists of stratum I participants enrolled at the maximum tolerated dose (phase 1) and the participants enrolled to the phase II part. The study was terminated because of poor accrual and the objective was not met.|||||
699698|NCT00021229|Primary|Number of Participants in Phase I Stratum II With Dose Limiting Toxicities (DLT) Observed During First 8 Weeks (Courses 1 and 2) of Imatinib Therapy|The dose limiting toxicity (DLT) analysis population consisted of phase I stratum II participants who developed DLT during the maximum tolerated dose (MTD) estimation period (courses 1 and 2) or who completed the MTD estimation period (courses 1 and 2) without DLTs. DLTs observed during courses 1 and 2 were used to estimate the MTD. The estimated MTD based on the DLT analysis population of 20 in stratum IIA was 465 mg/m2/day. An MTD was not established in stratum IIB as no DLTs were observed at the higher dose levels of 620 and 800 mg/m2/day.|Day 1 of Imatinib Mesylate Therapy to Week 8|Per protocol, participants included phase I stratum II participants who developed dose-limiting toxicities (DLT) during the maximum tolerated dose (MTD) estimation period (courses 1 and 2) or who completed the MTD estimation period (courses 1 and 2) without DLTs.||Participants|||Number
699699|NCT00021229|Primary|Number of Participants in Phase I Stratum I With Dose Limiting Toxicities (DLT) Observed During First 8 Weeks (Courses 1 and 2) of Imatinib Therapy|The dose limiting toxicity (DLT) analysis population consists of phase I stratum I participants who developed DLT during the maximum tolerated dose (MTD) estimation period (course 1 and 2) or who completed the MTD estimation period (courses 1 and 2) without DLTs. DLTs observed during courses 1 and 2 were used to estimate the MTD. The estimated MTD based on the 23 participants who either had a DLT during course 1 or 2 or completed courses 1 and 2 without DLT is 265 mg/m2/day.|Day 1 of Imatinib Mesylate Therapy to Week 8|Per protocol, participants included phase I stratum I participants who developed dose-limiting toxicities during the maximum tolerated dose (MTD) estimation period (courses 1 and 2) or who completed the MTD estimation period (courses 1 and 2) without dose-limiting toxicities.||Participants|||Number
699701|NCT00021255|Secondary|Percentage of Participants With Disease Free Survival at 10 Years|Disease free survival was defined as the interval from the date of randomization to the date of local, regional or metastatic relapse or the date of second primary cancer (with the exception of curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix) or death from any cause whichever occured first. Disease free survival was estimated using the Kaplan-Meier method.|From randomization until relapse or death or up to 10 years|ITT population.||percentage of participants||95% Confidence Interval|Number
699702|NCT00021255|Primary|Percentage of Participants With Disease Free Survival at 5 Years|Disease Free Survival was defined as the interval from the date of randomization to the date of local, regional or metastatic relapse or the date of second primary cancer (with the exception of curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix) or death from any cause whichever occured first. Disease free survival was estimated using the Kaplan-Meier method.|From randomization until relapse or death or up to 5 years|ITT population.||percentage of participants||95% Confidence Interval|Number
699703|NCT00021541|Primary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|8 years|Adverse event data is in compliance with DSMB (Data Safety Monitoring Board).||Participants|||Number
699704|NCT00021541|Primary|Median Time to Progression|Median time to progression is defined as a greater than or equal to 20% increase increase in the sum of the volume of all index lesions based on volumetric analysis utilizing magnetic resonance imaging (MRI).Start of phase A or phase B to time of progression.|8 years|phase A - 62 started and 2 were ineligible = 60 phase B - 43 started||Months||95% Confidence Interval|Median
699705|NCT00013611|Secondary|New or Recurrent Serious Disease Progression Events or Death|"Number of participants with fatal or non-fatal serious AIDS-related opportunistic disease.
A serious disease progression event is one of the following: progressive multifocal leukoencephalopathy (PML), lymphoma, Kaposi's sarcoma (visceral), AIDS dementia complex (ADC) stage II or higher, toxoplasmosis, histoplasmosis (systemic), cryptococcosis (systemic), disseminated Mycobacterium avium complex (MAC) disease, wasting syndrome, and cytomegalovirus (CMV) disease."|From randomization to date last known to be alive or November 15, 2008, whichever is earlier|||Participants|||Number
699706|NCT00013611|Secondary|CD4+ Cell Count|Mean CD4+ cell count (cells per cubic mm) averaged over follow-up|Every 4 months from randomization through date last known to be alive or November 15, 2008, whichever was earliest .|||cells per cubic mm||Standard Error|Mean
699707|NCT00013611|Secondary|Grade 4 Clinical Events|Grade 4 clinical events were defined as potentially life-threatening events (excluding opportunistic disease) requiring medical intervention.|From randomization to date last known to be alive or November 15, 2008, whichever is earlier|The outcome is the number of participants experiencing at least one grade 4 event.||Participants|||Number
699708|NCT00013611|Secondary|New or Recurrent Disease Progression Events|"Number of participants with fatal or non-fatal AIDS-related opportunistic disease.
AIDS-related opportunistic disease includes CDC Category C 1993 definition plus the following diseases: Aspergillosis, invasive; Bartonellosis; Chagas disease of the CNS; Herpes zoster, multidermal; Leishmaniasis, visceral; Lymphoma, Hodgkin's; Microsporidiosis (> 1 month's duration); Nocardiosis; Penicillium marneffti, disseminated; Pneumocystis carinii, extrapulmonary; Rhodococcus equi disease."|From randomization to date last known to be alive or November 15, 2008, whichever is earlier|||Participants|||Number
699709|NCT00013611|Secondary|All-cause Mortality|Number of participants who died.|From randomization to date last known to be alive or November 15, 2008, whichever is earlier|||Participants|||Number
699710|NCT00013611|Primary|New or Recurrent Disease Progression Events, as Defined, or Death.|"Number of participants with fatal or non-fatal AIDS-related opportunistic disease or death from any cause.
AIDS-related opportunistic disease includes CDC Category C 1993 definition plus the following diseases: Aspergillosis, invasive; Bartonellosis; Chagas disease of the CNS; Herpes zoster, multidermal; Leishmaniasis, visceral; Lymphoma, Hodgkin's; Microsporidiosis (> 1 month's duration); Nocardiosis; Penicillium marneffti, disseminated; Pneumocystis carinii, extrapulmonary; Rhodococcus equi disease."|From randomization to date last known to be alive or November 15, 2008, whichever is earlier|||Participants|||Number
699711|NCT00022490|Secondary|The Rate of Complete Hematologic Responses at 6 and 12 Months||6 and 12 months||||||
699712|NCT00022490|Secondary|The Rate of Minor Cytogenetic Responses at 6 and 12 Months||6 and 12 months||||||
699713|NCT00022490|Secondary|The Rate of Complete and Major Cytogenetic Responses at 12 Months||12 months||||||
699714|NCT00022490|Secondary|The Rate of Complete Cytogenetic Response at 6 Months||6 months||||||
699715|NCT00022490|Primary|The Rate of Major Cytogenetic Response at 6 Months|Cytogenetic response is defined in terms of the percentage of Philadelphia (Ph) chromosome. Major cytogenetic response is defined as 0-34% Ph-positive cells.|6 months|||Participants|||Number
699716|NCT00022516|Secondary|Breast Cancer-free Interval|Estimated percentage of patients alive and disease-free at 5 years from randomization, where breast cancer-free interval is defined as the time from randomization to invasive breast cancer recurrence at local, regional, or distant site, or invasive contralateral breast cancer; or censored at date of last follow up.|5-year estimates, reported at a median follow-up of 6.9 years|Intention-to-treat (N=1081 patients)||percentage of participants||95% Confidence Interval|Number
699717|NCT00022516|Secondary|Distant Recurrence-free Interval|Estimated percentage of patients alive and disease-free at 5 years from randomization, where distant recurrence-free Interval is defined as the time from randomization to invasive breast cancer recurrence at distant site, or invasive contralateral breast cancer; or censored at date of last follow up.|5-year estimates, reported at a median follow-up of 6.9 years|Intention-to-treat (N=1081 patients)||percentage of participants||95% Confidence Interval|Number
699718|NCT00022516|Secondary|Overall Survival|Estimated percentage of patients alive and disease-free at 5 years from randomization, where overall survival is defined as the time from randomization to death from any cause; or censored at date last known alive.|5-year estimates, reported at a median follow-up of 6.9 years|Intention to treat (N=1081 patients)||percentage of participants||95% Confidence Interval|Number
699802|NCT00023595|Secondary|H02: KCCQ Clinical Summary Score|This score represents the mean of the Physical Limitation and Total Symptom scores. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.||units on a scale||Inter-Quartile Range|Median
699719|NCT00022516|Primary|Disease-free Survival|Estimated percentage of patients alive and disease-free at 5 years from randomization, where disease-free survival is defined as the time from randomization to the first appearance of one of the following: invasive breast cancer recurrence at local, regional, or distant site, invasive contralateral breast cancer, second (non-breast) invasive cancer, or death without cancer event; or censored at date of last follow-up.|5-year estimates, reported at a median follow-up of 6.9 years|Intention to treat (N=1081 patients)||percentage of participants||95% Confidence Interval|Number
699720|NCT00022659|Secondary|Duration of Progression-free Survival||Up to 5 years||||||
699721|NCT00022659|Secondary|Overall Survival|The observed length of life from entry into the study to death or the date of last contact.|From study entry to death or last contact, up to 5 years.|Eligible and treated patients.||months||95% Confidence Interval|Median
699722|NCT00022659|Primary|Frequency and Severity of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events (CTCAE)||Up to 5 years||||||
699723|NCT00022659|Primary|Tumor Response|Complete and Partial Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0|Every other 3-week treatment cycle.|Eligible and treated patients.||percentage of participants||90% Confidence Interval|Number
699724|NCT00022659|Primary|Progression-free Survival at 6 Months|Whether or not the patient survived progression-free for at least 6 months.|Every other 3-week treatment cycle.|Eligible and treated patients.||percentage of participants||90% Confidence Interval|Number
699725|NCT00022672|Secondary|Number of Participants With Adverse Events|Number of participants with adverse events as a measure for safety as assessed by the collection of adverse events, laboratory tests for Hematology and Serum Chemistry, clinical assessments and cardiac monitoring.|Throughout the Study (Up to 5 years)|Safety population included all participants who received at least one dose of study drug.||Participants|||Number
699726|NCT00022672|Secondary|Percentage of Participants With Best Tumor Response at End of Study|Tumor Response levels were determined by the investigator and an Independent Response Evaluation Committee and Reconciled. Best Response was defined as the best response a patient achieves in the study.|End of Study (Up to 5 years)|Full Analysis Population includes all randomized participants who received study drug.||Percentage of participants|||Number
699727|NCT00022672|Secondary|Percentage of Participants With Overall Tumor Response at End of Study|Tumor Response levels were determined by the investigator and an Independent Response Evaluation Committee and Reconciled. Overall Response was defined as either complete response or partial response.|End of Study (Up to 5 years)|Participants from the Full Analysis Population (all randomized participants who received study drug) evaluable for response.||Percentage of participants|||Number
699728|NCT00022672|Secondary|Time to Response at End of Study|Time to response was defined as the number of days from the day of randomization to the day complete response or partial response was first noted.|End of Study (Up to 5 years)|Participants from the Full Analysis population (all randomized participants who received study drug) evaluable for response.||Months||Full Range|Median
699729|NCT00022672|Secondary|Duration of Response at End of Study|Duration of response was defined as the number of days from the day complete response or partial response was first noted to the day of progression of disease, death or last follow-up.|End of Study (Up to 5 years)|Participants from the Full Analysis population (all randomized participants who received study drug) evaluable for response.||Months||Full Range|Median
699730|NCT00022672|Secondary|Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Final Visit Compared to Baseline|"Participants rated their performance status using the ECOG Questionnaire on the following scale: 0=Fully active, perform all pre-disease activities without restriction; 1=Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature; 2=Ambulatory, capable of self-care, unable to carry out any work activities, up and about more than >50% of waking hours; 3=Capable of limited self-care, confined to bed or chair >50% of waking hours; 4=Completely disabled, not capable of any self-care, totally confined to bed or chair; 5=Dead.
The percentage of participants in the following categories:
Improved: Score decrease from baseline. Unchanged: Score the same as baseline. Worse: Score increase from baseline."|Baseline, Final Visit (Up to 24 Months)|Participants from the Full Analysis Population (includes all randomized participants who received study drug) with data available for analyses.||Percentage of participants|||Number
699731|NCT00022672|Secondary|Percentage of Participants With Best Tumor Response at 24 Months|Tumor Response levels were determined by the investigator and an Independent Response Evaluation Committee and Reconciled. Best Response was defined as the best response a patient achieves in the study.|24 Months|Participants from the Full Analysis Population (all randomized participants who received study drug) evaluable for response.||Percentage of participants|||Number
699732|NCT00022672|Secondary|Percentage of Participants With Overall Tumor Response at 24 Months|Tumor Response levels were determined by the investigator and an Independent Response Evaluation Committee and Reconciled. Overall Response was defined as either complete response or partial response.|24 Months|Participants from the Full Analysis Population (all randomized participants who received study drug) evaluable for response.||Percentage of participants|||Number
699733|NCT00022672|Secondary|Percentage of Participants With Two-Year Survival||24 Months|Full Analysis Population included all randomized participants who received study drug.||Percentage of participants|||Number
699734|NCT00022672|Secondary|Overall Survival at 24 Months|Overall Survival is defined as the number of days from randomization to death.|24 Months|||Months||95% Confidence Interval|Median
699735|NCT00022672|Secondary|Time to Response at 24 Months|Time to response was defined as the number of days from the day of randomization to the day complete response or partial response was first noted.|24 Months|Participants from the Full Analysis population (all randomized participants who received study drug) evaluable for response.||Months||Full Range|Median
699736|NCT00022672|Secondary|Duration of Response at 24 Months|Duration of response was defined as the number of days from the day complete response or partial response was first noted to the day of progression of disease, death or last follow-up.|24 Months|Participants from the Full Analysis population (all randomized participants who received study drug) evaluable for response.||Months||Full Range|Median
699737|NCT00022672|Secondary|Percentage of Participants With Clinical Benefit|Clinical Benefit was defined as stable disease for ≥ six months or complete response or partial response.|24 Months, End of Study (Up to 5 years)|||Percentage of participants|||Number
699738|NCT00022672|Primary|Progression Free Survival (PFS)|PFS was assessed by the investigator based on World Health Organization (WHO) criteria using radiographic tumor evaluations. Disease progression was defined as the appearance of any new lesion not previously identified or an estimated increase of 25% or more in existent bidimensionally or unidimensionally measurable lesions or progression of an existing non-measurable lesion. For bidimensionally measurable malignant lesions with an area of at least 2.0 centimeters squared (cm^2) an increase of 1.0 cm^2 was required and for unidimensionally measurable lesions of 1.0 cm or less an increase of 0.5 cm was required. PFS was defined as the number of days between date of randomization and date of documented disease progression or date of death. Kaplan Meier estimates of PFS are presented.|24 Months, End of Study (Up to 5 years)|Full analysis population included all randomized participants who received study drug.||Months||95% Confidence Interval|Median
699739|NCT00022698|Secondary|Number of Participants With Any Adverse Events, Serious Adverse Events and Deaths|An adverse event (AEs) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. A serious adverse event is defined as any event which was fatal (resulted in death), life-threatening (with immediate risk of death), resulted in a new or prolongation of a current hospitalization, resulted in persistent or significant disability or incapacity, was a congenital anomaly or birth defect, considered medically significant by the investigator, required intervention to prevent one or more of the outcomes listed above.|Approximately 43 Months|The Safety Population consisted of all participants who received at least 1 dose of any study drug and had at least one post-baseline safety assessment. This included participants in Cohort 1 and Cohort 2.||Number of participants|||Number
699740|NCT00022698|Secondary|Duration of Overall Complete Response|The duration of overall complete response was assessed from the time that measurement criteria were met for complete response until the first date that recurrent or progressive disease was objectively documented. Participants without observed progressive disease after an objective complete response were censored at the date of the last tumor assessment.|Approximately 43 Months|The All Patients Population included participants who received at least one dose of study drug in Cohort 1 or Cohort 2. Data for participants present at the time of assessment was used for analysis.||months|||Number
699741|NCT00022698|Secondary|Duration of Overall Response|Duration of overall response was assessed from the time that measurement criteria were first met for CR/PR (whichever is first recorded) until the first date that recurrent or progressive disease was documented. It was analyzed for responders only. Participants without observed progressive disease after an objective response were censored at the date of the last tumor assessment.|Approximately 43 Months|The All Patients Population included participants who received at least one dose of study drug in Cohort 1 or Cohort 2. Data for participants present at the time of assessment was used for analysis.||months||95% Confidence Interval|Median
699742|NCT00022698|Secondary|Time To Objective Response|The time to objective response is defined as the time from start of treatment to the date of first objective response. Participants who never responded during study were censored at the last tumor assessment or the date of last dose, whichever was later, or at the date of death if occurring prior to response.|Approximately 43 Months|The All Patients Population included participants who received at least one dose of study drug in Cohort 1 or Cohort 2.||months||95% Confidence Interval|Median
699743|NCT00022698|Secondary|Overall Survival|Overall Survival is defined as the time from start of treatment to the date of death. Participants who did not die were censored at the last date the participant was known to be alive.|Approximately 43 Months|The All Patients Population included participants who received at least one dose of study drug in Cohort 1 or Cohort 2.||months||95% Confidence Interval|Median
699744|NCT00022698|Secondary|Percentage of Participants With One-year Survival|Survival was measured as the time from start of treatment to the date of death or till one year whichever occurred first.|Up to Month 12|The All Patients Population included participants who received at least one dose of study drug in Cohort 1 or Cohort 2.||percentage of participants||95% Confidence Interval|Number
699745|NCT00022698|Secondary|Time to Treatment Failure|Time to treatment failure was assessed as the time from start of treatment to the time the participant was withdrawn due to any of the reasons such as adverse events, progressive disease, insufficient therapeutic response, death, failure to return, or refused treatment, did not cooperate or withdrew consent.|Approximately 43 Months|The All Patients Population included participants who received at least one dose of study drug in Cohort 1 or Cohort 2.||months||95% Confidence Interval|Median
699746|NCT00022698|Secondary|Time to Disease Progression|Time to disease progression was assessed as the time from start of treatment to the time the participant was first recorded as having disease progression or died due to causes other than disease progression. If a participant never progressed while being followed, he/she was censored at the date of the last tumor assessment or the date of the last dose if no post-baseline tumor measurement was available.|Approximately 43 Months|The All Patients Population included participants who received at least one dose of study drug in Cohort 1 or Cohort 2.||months||95% Confidence Interval|Median
699747|NCT00022698|Primary|Tumor Response Rate Based on Tumor Measurement as Per Response Evaluation Criteria In Solid Tumors Version 1.0 (RECIST 1.0)|Objective Response Rate (ORR) is defined as the percentage of participants with complete response (CR) or partial response (PR) according to response evaluation criteria in solid tumors (RECIST 1.0). CR is defined as the disappearance of all target and non-target lesions and normalization of tumor marker level. PR is defined as a greater than or equal to (>/=) 30% decrease in the sum of the longest diameter (LD) of the target lesions, taking as reference the baseline sum of LD. Participants who did not have a post-baseline tumor measurement were considered non-responders in the assessment of ORR.|Approximately 43 Months|The All Patients Population included participants who received at least one dose of study drug in Cohort 1 or Cohort 2.||percentage of participants|||Number
699748|NCT00022763|Secondary|Number of Participants With Worst Local Injection Site Reactions|Numbers of Participants With worst local injection site reactions were reported. Localized injection site reactions like erythema, induration, pruritus, nodule and cyst, and ecchymosis were recorded.|Up to Week 96|Safety Analysis Population: All participants who received at least one dose of study medication were included.||participants|||Number
699751|NCT00022763|Secondary|Number of Participants With Treatment Emergent Grade 3 or Grade 4 Laboratory Abnormalities|Pediatric AIDS Clinical Trials Group (PACTG) toxicity grading scale was used for reviewing and grading clinically significant laboratory abnormalities. PACTG Grade 3 and Grade 4 were considered Severe and life threatening, respectively.|Up to Week 96|Safety Analysis Population: All participants who received at least one dose of study medication were included.||participants|||Number
699752|NCT00022763|Secondary|Number of Participants With Adverse Events (AEs) and Serious AEs|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event.|Up to Week 4 after discontinuation of therapy|Safety Analysis Population: All participants who received at least one dose of study medication were included.||participants|||Number
699753|NCT00022763|Secondary|AUC12h Ratio of Enfuvirtide Metabolite (Ro 50-6343)/ENF (Ro 29-9800)|The ratio of the area under plasma concentration-time curve from time 0 to 12 hours of Enfuvirtide Metabolite (Ro 50-6343) versus enfuvirtide was calculated.|Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1)|Intensive PK Analysis Population: The first 12 participants enrolled per age group and all children aged 3 to 6 years who underwent intensive pharmacokinetic sampling at week 1 were included within the intensive PK analysis population.||Ratio||Standard Deviation|Mean
699754|NCT00022763|Secondary|Minimum Plasma Concentration (Ctrough) for Enfuvirtide and Its Metabolite (Ro 50-6343)|Ctrough is defined as the lowest concentration that a drug reaches before the next dose is administered.|Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1)|Intensive PK Analysis Population: The first 12 participants enrolled per age group and all children aged 3 to 6 years who underwent intensive pharmacokinetic sampling at week 1 were included within the intensive PK analysis population.||mcg/mL||Standard Deviation|Mean
699755|NCT00022763|Secondary|Time to Maximum Plasma Concentration (Tmax) for Enfuvirtide|Tmax is defined as actual sampling time to reach maximum observed analyte concentration.|Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1)|Intensive PK Analysis Population: The first 12 participants enrolled per age group and all children aged 3 to 6 years who underwent intensive pharmacokinetic sampling at week 1 were included within the intensive PK analysis population.||hour||Standard Deviation|Mean
699756|NCT00022763|Secondary|Maximum Plasma Concentration (Cmax) for Enfuvirtide and Its Metabolite (Ro 50-6343)|The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration. Cmax was calculated from plasma concentration-time data (on Day 7) using standard non-compartmental pharmacokinetic methods.|Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1)|Intensive PK Analysis Population: The first 12 participants enrolled per age group and all children aged 3 to 6 years who underwent intensive pharmacokinetic sampling at week 1 were included within the intensive PK analysis population.||mcg/mL||Standard Deviation|Mean
699757|NCT00022763|Primary|Area Under the Plasma Concentration Time Curve (AUC) From 0-12 Hours for Enfuvirtide and Its Metabolite (Ro 50-6343)|The Area Under the Plasma Concentration-Time Curve (AUC) is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption. AUC was calculated from plasma concentration-time data (on Day 7) using standard non-compartmental pharmacokinetic methods.|Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1)|Intensive PK Analysis Population: The first 12 participants enrolled per age group and all children aged 3 to 6 years who underwent intensive pharmacokinetic sampling at week 1 were included within the intensive PK analysis population.||microgram hour per milliliter (mcg.h/mL)||Standard Deviation|Mean
699758|NCT00023309|Secondary|Histological Response|A histological response was defined as a decrease in the HAI score by at least three points with no worsening of the Ishak fibrosis score.|week 196 from randomization|Analysis was intention to treat. Patients with missing values at timeframe of interest was taken as random missing. No imputation was applied.||participants|||Number
699759|NCT00023309|Secondary|Biological Response|A biochemical response was defined as a decrease in serum ALT levels into the normal range (<41 U/L).|week 196 from randomization|Intention to treat||participants|||Number
699760|NCT00023309|Secondary|Virological Response|A virological response was defined as a decrease in HBV DNA levels to undetectable by the Amplicor assay (<500 copies/mL).|Week 196 from randomization|Intention to treat||participants|||Number
699761|NCT00023309|Secondary|HBeAg Loss at Week 196|Loss of hepatitis B surface antigen (HBsAg) at week 196|Week 196 from randomization|Analysis was intention to treat. Patients with missing values at timeframe of interest was taken as random missing. No imputation was applied.||participants|||Number
699762|NCT00023309|Primary|Maintained Combined Response (Virological, Biochemical and Histological Response).|A maintained combined response was defined as a combination of a virological, biochemical and histological responses at weeks 48 and 192. A virological response was defined as a decrease in HBV DNA levels to undetectable by the Amplicor assay (<500 copies/mL). A biochemical response was defined as a decrease in serum ALT levels into the normal range (<41 U/L). A histological response was defined as a decrease in the HAI score by at least three points with no worsening of the Ishak fibrosis score.|196 weeks from randomization|The analysis was intention to treat. Patients with missing values at week 196 were treated as random missing. No imputation was applied.||participants|||Number
699763|NCT00023322|Secondary|Histological Response at 5 Years|Histological response is defined as at least 3 point improvement in inflammatory score or 1 point improvement in fibrosis score of the HAI at each liver biopsy.|5 years|||participants|||Number
699764|NCT00023322|Primary|Histological Response at 3 Years|Histological response is defined as at least 3 point improvement in inflammatory score or 1 point improvement in fibrosis score of the HAI at each liver biopsy.|3 years|Intention to treat||participants|||Number
699773|NCT00023452|Secondary|Percentage of Participants With Methadone Withdrawal Associated With 3RPT/INH and 9INH Among Participants Receiving Concomitant Methadone|Among participants concomitantly receiving methadone, the development of methadone withdrawal (defined as having >3 new symptoms for >7 days: nausea and vomiting, abdominal cramps, body aches, restlessness, irritability, dilated pupils, tremors, involuntary twitching, lacrimation, rhinorrhea, sneezing, yawning, excessive perspiration, goose flesh, or diarrhea).|Baseline to Month 33||12/2015||||
699765|NCT00023452|Secondary|Cumulative Rate of Participants <12 Years Old With Culture-Confirmed or Probable (Clinical) TB Disease Within 33 Months of Enrollment|Cumulative TB disease rate was defined as number of participants <12 years old with culture-confirmed TB disease (defined as positive culture for MTB) or probable (clinical) TB disease (defined as objective evidence of clinical TB disease [cough, fever, night sweats, weight loss, or hemoptysis] based on history or physical exam plus radiograph, CT scan, other diagnostic tests PLUS response to antituberculosis therapy AND objective improvement of radiograph or other diagnostic tests; OR evidence of granuloma with organism positive for AFB], or caseating granulomata at autopsy or biopsy) between enrollment and the 990th day of the trial (33 months after enrollment, or end of the trial) per 100 participants w/33 months of follow-up and was calculated using survival analysis methods (Kaplan-Meier approach).|Baseline up to Month 33||12/2015||||
699766|NCT00023452|Secondary|Cumulative Rate of Participants <18 Years Old With Culture-Confirmed or Probable (Clinical) TB Disease Within 33 Months of Enrollment|Cumulative TB disease rate was defined as number of participants <18 years old with culture-confirmed TB disease (defined as positive culture for MTB) or probable (clinical) TB disease (defined as objective evidence of clinical TB disease [cough, fever, night sweats, weight loss, or hemoptysis] based on history or physical exam plus radiograph, CT scan, other diagnostic tests PLUS response to antituberculosis therapy AND objective improvement of radiograph or other diagnostic tests; OR evidence of granuloma with organism positive for AFB], or caseating granulomata at autopsy or biopsy) between enrollment and the 990th day of the trial (33 months after enrollment, or end of the trial) per 100 participants w/33 months of follow-up and was calculated using survival analysis methods (Kaplan-Meier approach).|Baseline up to Month 33||12/2015||||
699767|NCT00023452|Secondary|Cumulative Rate of HIV-Infected Participants With Culture-Confirmed or Probable TB Disease at 24 Months After Completion of Study Therapy|Cumulative TB disease rate was defined as number of HIV-infected participants with culture-confirmed TB (defined as positive culture for MTB) or probable (clinical) TB disease (defined as objective evidence of clinical TB disease [cough, fever, night sweats, weight loss, or hemoptysis] based on history or physical exam plus radiograph, CT scan, other diagnostic tests PLUS response to antituberculosis therapy AND objective improvement of radiograph or other diagnostic tests; OR evidence of granuloma with organism positive for AFB], or caseating granulomata at autopsy or biopsy) between enrollment and 24 months after completion of study therapy per 100 participants with up to 33 months of follow-up and was calculated using survival analysis methods (Kaplan-Meier approach).|Baseline up to Month 27 (3RPT/INH) or Month 33 (9INH)||12/2015||||
699768|NCT00023452|Secondary|Cumulative Rate of Culture-Confirmed or Probable TB Disease in HIV-Infected Participants Within 33 Months After Enrollment|Cumulative TB disease rate was defined as number of HIV-infected participants ≥2 years old with culture-confirmed TB disease (defined as positive culture for MTB) or probable (clinical) TB disease (defined as objective evidence of clinical TB disease [cough, fever, night sweats, weight loss, or hemoptysis] based on history or physical exam plus radiograph, CT scan, other diagnostic tests PLUS response to antituberculosis therapy AND objective improvement of radiograph or other diagnostic tests; OR evidence of granuloma with organism positive for AFB], or caseating granulomata at autopsy or biopsy) between enrollment and the 990th day of the trial (33 months after enrollment, or end of the trial) per 100 participants w/33 months of follow-up and was calculated using survival analysis methods (Kaplan-Meier approach).|Baseline to Month 33||12/2015||||
699769|NCT00023452|Secondary|Percentage of Participants With Resistance to Study Medications in Isolates of MTB From Participants Who Developed Active TB Disease Within 33 Months of Enrollment|Drug-susceptibility testing (DST) was performed on isolates of MTB obtained from participants who developed signs and symptoms of active TB disease (including sputum specimens or specimens from appropriate body site for extrapulmonary TB disease). DST was performed at site's local laboratory and sent to Sponsor for confirmatory susceptibility testing. DST included all drugs currently used to treat TB disease, including pyrazinamide (PZA) and fluoroquinolones. Susceptibility was tested for other drugs at the Sponsor laboratory at the following concentrations: INH, 0.02, 1.0, and 5.0 micrograms per milliliter (µg/mL) and rifampin (RIF), 1.0 µg/mL. Isolates resistant to RIF were assumed to be resistant to RPT.|Baseline up to Month 33|N equals the number of participants who developed active TB disease during the study for which DST was performed.||percentage of participants|||Number
699770|NCT00023452|Secondary|Cumulative Rate of Culture-Confirmed TB Disease in Participants ≥18 Years of Age AND Culture Confirmed or Probable (Clinical) TB Disease Among Participants <18 Years of Age Who Completed Study Phase Therapy Within 33 Months of Enrollment|Cumulative TB disease rate was defined as number of participants ≥18 years old with culture-confirmed TB disease (defined as positive culture for MTB) and <18 years old with probable (clinical) TB disease (defined as objective evidence of clinical TB disease [cough, fever, night sweats, weight loss, or hemoptysis] based on history or physical exam plus radiograph, CT scan, other diagnostic tests PLUS response to antituberculosis therapy AND objective improvement of radiograph or other diagnostic tests; OR evidence of granuloma with organism positive for AFB], or caseating granulomata at autopsy or biopsy) between enrollment and 33 months after enrollment (for those who completed therapy within 33 months) per 100 participants w/33 months of follow-up and was calculated using survival analysis methods (Kaplan-Meier approach).|Baseline up to Month 33|Per Protocol Population: all enrolled and eligible participants (MITT Population) who completed study drug within targeted time period (11-12 3RPT/INH doses within 10-16 weeks; 240-270 INH doses within 35-52 weeks) or developed TB disease or died while on study therapy (or follow-up) but completed ≥75% of expected number of doses prior to event.||TB cases per 100 participants w/followup|||Number
699771|NCT00023452|Secondary|Percentage of Participants Who Completed the Treatment Regimen|Completion in the 3RPT/INH arm was defined as: received 12 doses of RPT/INH within 16 weeks (12 weeks optimal). However, participants were considered to have completed therapy if at least 11 doses of RPT/INH had been received (~90%) during the 16-week time period. Completion in the 9INH arm was defined as: received 270 doses of INH within 52 weeks (39 weeks optimal). However, participants were considered to have completed therapy if at least 240 doses of INH were received (~90%) during the 52-week period.|Baseline up to Month 3 (3RPT/INH) or Month 9 (9INH)|MITT Population||percentage of participants|||Number
699772|NCT00023452|Secondary|Percentage of Participants With Drug Discontinuation for Any Reason Associated With 3RPT/INH or 9INH|Drug discontinuations for any reason associated with 3RPT/INH or 9INH included all reasons for discontinuation from study treatment, regardless of relationship to treatment.|Baseline up to Month 3 (3RPT/INH) or Month 9 (9INH)|MITT Population||percentage of participants|||Number
699775|NCT00023452|Secondary|Percentage of Patients With Grade 3 or 4 Drug Toxicities Associated With 3RPT/INH or 9INH|Drug toxicities (or AEs) were graded using Common Toxicity Criteria (CTC version 2.0, Publish Date April 30, 1999, Cancer Therapy Evaluation Program). Grade 3 and 4 drug toxicities associated with 3RPT/INH or 9INH were defined as treatment-related Grade 3 or 4 AEs (considered either possibly, probably, or definitely related to the study drug by the investigator).|Baseline up to 60 days after the last dose of study drug (Month 5 [3RPT/INH] or Month 11 [9INH])|Safety Population||percentage of participants|||Number
699776|NCT00023452|Secondary|Percentage of Participants With Drug Discontinuation Due to Adverse Drug Reactions Associated With 3RPT/INH or 9INH|Discontinuation of study drug due to an adverse drug reaction associated with either 3RPT/INH or 9INH was defined as discontinuing treatment and/or study due to a treatment-related adverse event (AE) (considered either possibly, probably, or definitely related to the study drug by the investigator).|Baseline up to 60 days after the last dose of study drug (Month 5 [3RPT/INH] or Month 11 [9INH])|Safety Population: all participants who enrolled in the study and took at least 1 dose of study drug.||percentage of participants|||Number
699777|NCT00023452|Secondary|Cumulative Rate of Culture-Confirmed or Probable (Clinical) TB Disease (Regardless of Age) At 33 Months After Enrollment|Cumulative TB disease rate was defined as number of participants (regardless of age) with culture-confirmed TB disease (defined as positive culture for MTB]) or probable (clinical) TB disease (defined as objective evidence of clinical TB disease [cough, fever, night sweats, weight loss, or hemoptysis] based on history or physical exam plus radiograph, CT scan, other diagnostic tests PLUS response to antituberculosis therapy AND objective improvement of radiograph or other diagnostic tests; OR evidence of granuloma with organism positive for AFB, or caseating granulomata at autopsy or biopsy) between enrollment and the 990th Day of the Trial (33 months after enrollment, or end of the trial) per 100 participants w/33 months of follow-up and was calculated using survival analysis methods (Kaplan-Meier approach).|Baseline up to 33 Months|||TB cases per 100 participants w/followup|||Number
699778|NCT00023452|Secondary|Cumulative Rate of Culture-Confirmed TB Disease in Participants ≥18 Years of Age AND Culture-Confirmed or Probable (Clinical) TB Disease in Participants <18 Years of Age at 24 Months Following Completion of Study Therapy|Cumulative TB disease rate was defined as number of participants ≥18 years old with culture-confirmed TB disease (defined as positive culture for MTB) and those <18 years old with probable (clinical) TB disease (defined as objective evidence of clinical TB disease [cough, fever, night sweats, weight loss, or hemoptysis] based on history or physical exam plus radiograph, CT scan, other diagnostic tests PLUS response to antituberculosis therapy AND objective improvement of radiograph or other diagnostic tests; OR evidence of granuloma with organism positive for AFB], or caseating granulomata at autopsy or biopsy) between enrollment and 24 months after completion of study therapy per 100 participants with up to 33 months of follow-up and was calculated using survival analysis methods (Kaplan-Meier approach).|Baseline up to Month 27 (3RPT/INH) or Month 33 (9INH)|MITT Population||TB cases per 100 participants w/followup|||Number
699779|NCT00023452|Primary|Cumulative Rate of Culture-Confirmed TB Disease in Participants ≥18 Years of Age AND Culture-Confirmed or Probable (Clinical) TB Disease in Participants Less Than [<]18 Years of Age at 33 Months After Enrollment|Cumulative TB disease rate defined as number of participants ≥18 years old with culture-confirmed TB disease (defined as positive culture for Mycobacterium tuberculosis [MTB]) and those <18 years old with probable (clinical) TB disease (defined as objective evidence of clinical TB disease [cough, fever, night sweats, weight loss, or hemoptysis] based on history or physical exam plus radiograph, computed tomography [CT] scan, other diagnostic tests PLUS response to antituberculosis therapy AND objective improvement of radiograph or other diagnostic tests; OR evidence of granuloma with organism positive for acid-fast bacilli [AFB], or caseating granulomata at autopsy or biopsy) between enrollment and the 990th Day of the Trial (33 months after enrollment, or end of the trial) per 100 participants with (w/)33 months of follow-up calculated using survival analysis methods (Kaplan-Meier approach).|Baseline up to Month 33|Modified Intention-to-Treat (MITT) Population: all participants who enrolled in study and were eligible (Ineligible=source TB case resistant to INH or rifampin; source TB case culture-negative for MTB; positive TST not confirmed; MTB drug susceptibility test results not available for source TB case; or TB disease at enrollment).||TB cases per 100 participants w/followup|||Number
699780|NCT00023595|Secondary|H02: Cost of Care|Hospital costs and physician fees for US patients|index hospital admission|US patients with hospital bills||2008 US Dollars||Standard Deviation|Mean
699781|NCT00023595|Secondary|H01: Cost of Care|Hospital costs and physician fees for US patients|index hospital admission|US patients with hospital bills||2009 US Dollars||Standard Deviation|Mean
699782|NCT00023595|Secondary|H02: General Health Rating Scale|This single item asks patients to describe their health status over the past month on a scale from 0 to 100, where 0 = death and 100 = excellent health.|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.||units on a scale||Inter-Quartile Range|Median
699783|NCT00023595|Secondary|H01: General Health Rating Scale|This single item asks patients to describe their health status over the past month on a scale from 0 to 100, where 0 = death and 100 = excellent health.|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.||units on a scale||Standard Deviation|Mean
699784|NCT00023595|Secondary|H02: Cardiac Self-Efficacy (CSE) Control Symptoms Subscale|"These 8 items assess patients' ability to control symptoms such as chest pain and breathlessness by taking their medications and adjusting their activity levels. Response choices range from Not at all confident (1) to Completely confident (5). The mean score is transformed to a 0-100 scale where higher scores reflect more confidence."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.||units on a scale||Inter-Quartile Range|Median
699785|NCT00023595|Secondary|H01: Cardiac Self-Efficacy (CSE) Control Symptoms Subscale|"These 8 items assess patients' ability to control symptoms such as chest pain and breathlessness by taking their medications and adjusting their activity levels. Response choices range from Not at all confident (1) to Completely confident (5). The mean score is transformed to a 0-100 scale where higher scores reflect more confidence."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.||units on a scale||Standard Deviation|Mean
699803|NCT00023595|Secondary|H01: KCCQ Clinical Summary Score|This score represents the mean of the Physical Limitation and Total Symptom scores. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.||units on a scale||Standard Deviation|Mean
699786|NCT00023595|Secondary|H02: Cardiac Self-Efficacy (CSE) Maintain Functioning Subscale|"These 5 items assess patients' ability to maintain their usual social, family, and physical activities. Response choices range from Not at all confident (1) to Completely confident (5). The mean score is transformed to a 0-100 scale where higher scores reflect more confidence."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.||units on a scale||Inter-Quartile Range|Median
699787|NCT00023595|Secondary|H01: Cardiac Self-Efficacy (CSE) Maintain Functioning Subscale|"These 5 items assess patients' ability to maintain their usual social, family, and physical activities. Response choices range from Not at all confident (1) to Completely confident (5). The mean score is transformed to a 0-100 scale where higher scores reflect more confidence."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.||units on a scale||Standard Deviation|Mean
699788|NCT00023595|Secondary|H02: Percentage of Patients With a Score of >= 16 on the Center for Epidemiological Studies Depression (CES-D) Scale|"These 20 items assess depressive symptomatology, and responses choices range from Rarely or none of the time (0) to Most or all of the time (3). Scale scores can therefore range from 0 to 60, although scores greater than or equal to 16 are considered high."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.||percentage of participants|||Number
699789|NCT00023595|Secondary|H01: Percentage of Patients With a Score of >= 16 on the Center for Epidemiological Studies Depression (CES-D) Scale|"These 20 items assess depressive symptomatology, and responses choices range from Rarely or none of the time (0) to Most or all of the time (3). Scale scores can therefore range from 0 to 60, although scores greater than or equal to 16 are considered high."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.||percentage of participants|||Number
699790|NCT00023595|Secondary|H02: EQ-5D Health Status Index Score|"This 5-item scale describes a patient's health in terms of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Choices for each dimension are No problems (1), Moderate problems (2), or Extreme problems (3). A scoring algorithm with utility weights is then applied to these 5 items to generate index scores ranging from -0.11 (i.e., 33333) to 1.0 (i.e., 11111) on a scale where 0.0 = death and 1.0 = perfect health. (These scores can be multiplied by 100 to produce a scale from -11 to 100 that more closely resembles the Visual Analog Scale.)"|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.||units on a scale||Inter-Quartile Range|Median
699791|NCT00023595|Secondary|H01: EQ-5D Health Status Index Score|"This 5-item scale describes a patient's health in terms of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Choices for each dimension are No problems (1), Moderate problems (2), or Extreme problems (3). A scoring algorithm with utility weights is then applied to these 5 items to generate index scores ranging from -0.11 (i.e., 33333) to 1.0 (i.e., 11111) on a scale where 0.0 = death and 1.0 = perfect health. These scores were multiplied by 100 to produce a scale from -11 to 100 that more closely resembles the Visual Analog Scale."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.||units on a scale||Standard Deviation|Mean
699792|NCT00023595|Secondary|H02: EQ-5D Visual Analog Scale|This 0-100 scale records the patient's self-rated health on a vertical scale where 0 = worst imaginable health and 100 = perfect health.|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.||units on a scale||Inter-Quartile Range|Median
699793|NCT00023595|Secondary|H01: EQ-5D Visual Analog Scale|Euro QoL 5 Dimensions Quality of Life Instrument (EQ-5D): This 0-100 scale records the patient's self-rated health on a vertical scale where 0 = worst imaginable health and 100 = perfect health.|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.||units on a scale||Standard Deviation|Mean
699794|NCT00023595|Secondary|H02: Seattle Angina Questionnaire (SAQ) Quality-of-Life Subscale|These 3 items measure the patient's general satisfaction with life. Response choices range from 1 (least enjoyment) to 5 (high satisfaction). The mean score is transformed to a 0-100 scale where higher scores reflect better outcomes.|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.||units on a scale||Inter-Quartile Range|Median
699795|NCT00023595|Secondary|H01:Seattle Angina Questionnaire (SAQ) Quality-of-Life Subscale|These 3 items measure the patient's general satisfaction with life. Response choices range from 1 (least enjoyment) to 5 (high satisfaction). The mean score is transformed to a 0-100 scale where higher scores reflect better outcomes.|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.||units on a scale||Standard Deviation|Mean
699796|NCT00023595|Secondary|H02: Seattle Angina Questionnaire (SAQ) Anginal Stability Subscale|"This item assesses the change in chest pain over the last 4 weeks. Response choices range from Much more often (1) to None (6). The mean response is transformed to a 0-100 scale where 50 represents no change and a higher score indicates less angina."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.||units on a scale||Inter-Quartile Range|Median
699797|NCT00023595|Secondary|H01: Seattle Angina Questionnaire (SAQ) Anginal Stability Subscale|"This item assesses the change in chest pain over the last 4 weeks. Response choices range from Much more often (1) to None (6). The mean response is transformed to a 0-100 scale where 50 represents no change and a higher score indicates less angina."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.||units on a scale||Standard Deviation|Mean
699798|NCT00023595|Secondary|H02: Seattle Angina Questionnaire (SAQ) Anginal Frequency Subscale|"These 2 items assess the frequency of chest pain over the last 4 weeks. Response choices range from 4 or more times a day (1) to None (6). The mean response is transformed to a 0-100 scale where higher scores reflect less frequent angina."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.||units on a scale||Inter-Quartile Range|Median
699799|NCT00023595|Secondary|H01: Seattle Angina Questionnaire (SAQ) Anginal Frequency Subscale|"These 2 items assess the frequency of chest pain over the last 4 weeks. Response choices range from 4 or more times a day (1) to None (6). The mean response is transformed to a 0-100 scale where higher scores reflect less frequent angina."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.||units on a scale||Standard Deviation|Mean
699800|NCT00023595|Secondary|H02: KCCQ Overall Summary Score|This score represents the mean of these 4 scores: Physical Limitation, Total Symptom, Quality of Life, and Social Limitation. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.||units on a scale||Inter-Quartile Range|Median
699804|NCT00023595|Secondary|H02: KCCQ Social Limitation|"These 4 items assess how much heart failure has affected the patient's lifestyle. Response choices range from Severely limited (1) to Did not limit at all (5). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.||units on a scale||Inter-Quartile Range|Median
699805|NCT00023595|Secondary|H01: KCCQ Social Limitation|"These 4 items assess how much heart failure has affected the patient's lifestyle. Response choices range from Severely limited (1) to Did not limit at all (5). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.||units on a scale||Standard Deviation|Mean
699806|NCT00023595|Secondary|H02: KCCQ Quality-of-Life Scale|These 3 items assess the effect of heart failure on the patient's enjoyment of life. Response choices range from 1 (worst state) to 5 (best state). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.||units on a scale||Inter-Quartile Range|Median
699807|NCT00023595|Secondary|H01: KCCQ Quality-of-Life Scale|These 3 items assess the effect of heart failure on the patient's enjoyment of life. Response choices range from 1 (worst state) to 5 (best state). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.||units on a scale||Standard Deviation|Mean
699808|NCT00023595|Secondary|H02: KCCQ Total Symptoms|This score represents the mean of the Symptom Frequency and Symptom Burden scores. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.||units on a scale||Inter-Quartile Range|Median
699809|NCT00023595|Secondary|H01: KCCQ Total Symptoms|This score represents the mean of the Symptom Frequency and Symptom Burden scores. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.||units on a scale||Standard Deviation|Mean
699810|NCT00023595|Secondary|H02: KCCQ Symptom Burden|"These 3 items assess how much the patient has been bothered by shortness of breath, fatigue, and ankle swelling over the past 2 weeks. Response choices range from extremely bothersome (1) to Not at all bothersome (5). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.||units on a scale||Inter-Quartile Range|Median
699811|NCT00023595|Secondary|H01: KCCQ Symptom Burden|"These 3 items assess how much the patient has been bothered by shortness of breath, fatigue, and ankle swelling over the past 2 weeks. Response choices range from extremely bothersome (1) to Not at all bothersome (5). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.||units on a scale||Standard Deviation|Mean
699812|NCT00023595|Secondary|H02: KCCQ Symptom Frequency|"These 4 items assess how many times the patient has been bothered by shortness of breath, fatigue, and ankle swelling over the past 2 weeks. Response choices vary, but they range from Every morning or Every night or All of the time (1) to Never over the past 2 weeks (either 5 or 7). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.||units on a scale||Inter-Quartile Range|Median
699813|NCT00023595|Secondary|H01: KCCQ Symptom Frequency|"These 4 items assess how many times the patient has been bothered by shortness of breath, fatigue, and ankle swelling over the past 2 weeks. Response choices vary, but they range from Every morning or Every night or All of the time (1) to Never over the past 2 weeks (either 5 or 7). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.||units on a scale||Standard Deviation|Mean
699814|NCT00023595|Secondary|H02: KCCQ Symptom Stability|"This item assesses changes in shortness of breath or fatigue over the past 2 weeks. Response choices range from Much worse (1) to Much better (5). Item score is transformed to a 0-100 scale with a high score representing a better outcome."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.||units on a scale||Inter-Quartile Range|Median
699815|NCT00023595|Secondary|H01: KCCQ Symptom Stability|"This item assesses changes in shortness of breath or fatigue over the past 2 weeks. Response choices range from Much worse (1) to Much better (5). Item score is transformed to a 0-100 scale with a high score representing a better outcome."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.||units on a scale||Standard Deviation|Mean
699816|NCT00023595|Secondary|H02: KCCQ Physical Limitation Scale|"These 6 items assess ability to perform various activities of daily living. Response choices range from Extremely limited (1) to Not at all limited (5). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.||units on a scale||Inter-Quartile Range|Median
699817|NCT00023595|Secondary|H01: KCCQ Physical Limitation Scale|"Kansas City Cardiomyopathy Questionnaire (KCCQ)Physical Limitation Scale: These 6 items assess ability to perform various activities of daily living. Response choices range from Extremely limited (1) to Not at all limited (5). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.||units on a scale||Standard Deviation|Mean
699818|NCT00023595|Secondary|H02: SF-12 Mental Component Summary (MCS) Scale|Twelve items that reflect both physical and mental health are selected from the SF-36 subscales and combined according to an algebraic formula using published weights and constants: (a) First, the items are coded so that a higher value indicates better health; (b) then indicator variables (1/0) are created for the item response choice categories; (c) next, the 35 indicator variables are weighted using “mental” regression weights from the general US population and summed to produce the MCS-12 score; and (d) finally, a normalized score (with a mean of 50 and standard deviation of 10) is obtained by adding the “mental” constant from the scoring table to the sum of the 35 products.|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.||units on a scale||Inter-Quartile Range|Median
725194|NCT00351273|Secondary|Psoriatic Arthritis Response Criteria (PsARC): Swollen Joint Count, Tender Joint Count, Physician and Patient Global Assessment||Months 6 and 9||||||
699819|NCT00023595|Secondary|H01: SF-12 Mental Component Summary (MCS) Scale|Twelve items that reflect both physical and mental health are selected from the SF-36 subscales and combined according to an algebraic formula using published weights and constants: (a) First, the items are coded so that a higher value indicates better health; (b) then indicator variables (1/0) are created for the item response choice categories; (c) next, the 35 indicator variables are weighted using “mental” regression weights from the general US population and summed to produce the MCS-12 score; and (d) finally, a normalized score (with a mean of 50 and standard deviation of 10) is obtained by adding the “mental” constant from the scoring table to the sum of the 35 products.|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.||units on a scale||Standard Deviation|Mean
699820|NCT00023595|Secondary|H02: SF-12 Physical Component Summary (PCS) Scale|Twelve items that reflect both physical and mental health are selected from the SF-36 subscales and combined according to an algebraic formula using published weights and constants: (a) First, the items are coded so that a higher value indicates better health; (b) then indicator variables (1/0) are created for the item response choice categories; (c) next, the 35 indicator variables are weighted using “physical” regression weights from the general US population and summed to produce the PCS-12 score; and (d) finally, a normalized score (with a mean of 50 and standard deviation of 10) is obtained by adding the “physical” constant from the scoring table to the sum of the 35 products.|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.||units on a scale||Inter-Quartile Range|Median
699821|NCT00023595|Secondary|H01:SF-12 Physical Component Summary (PCS) Scale|Twelve items that reflect both physical and mental health are selected from the SF-36 subscales and combined according to an algebraic formula using published weights and constants: (a) First, the items are coded so that a higher value indicates better health; (b) then indicator variables (1/0) are created for the item response choice categories; (c) next, the 35 indicator variables are weighted using “physical” regression weights from the general US population and summed to produce the PCS-12 score; and (d) finally, a normalized score (with a mean of 50 and standard deviation of 10) is obtained by adding the “physical” constant from the scoring table to the sum of the 35 products.|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.||units on a scale||Standard Deviation|Mean
699822|NCT00023595|Secondary|H02: SF-36 Vitality Subscale|"These 4 items assess energy level and fatigue. Response choices range from All of the time (1) to None of the time (6). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better vitality. (Final scores are normalized to a mean of 50 and standard deviation of 10.)"|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.||units on a scale||Inter-Quartile Range|Median
699823|NCT00023595|Secondary|H01:SF-36 Vitality Subscale|"These 4 items assess energy level and fatigue. Response choices range from All of the time (1) to None of the time (6). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better vitality. (Final scores are normalized to a mean of 50 and standard deviation of 10.)"|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.||units on a scale||Standard Deviation|Mean
699824|NCT00023595|Secondary|H02: SF-36 Social Functioning Subscale|"These 2 items assess the limitations on social activities with others. Response choices range from Extremely or All of the time (1) to Not at all or None of the time (5). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better social functioning. (Final scores are normalized to a mean of 50 and standard deviation of 10.)"|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.||units on a scale||Inter-Quartile Range|Median
699825|NCT00023595|Secondary|H01:SF-36 Social Functioning Subscale|"These 2 items assess the limitations on social activities with others. Response choices range from Extremely or All of the time (1) to Not at all or None of the time (5). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better social functioning. (Final scores are normalized to a mean of 50 and standard deviation of 10.)"|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.||units on a scale||Standard Deviation|Mean
699826|NCT00023595|Secondary|H02: SF-36 Role Emotional Subscale|"These 3 items assess limitations and difficulty performing work or other usual activities as a result of any emotional problems (such as feeling depressed or anxious). Response choices are either Yes (1) or No (2). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better outcomes. (Final scores are normalized to a mean of 50 and standard deviation of 10.)"|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.||units on a scale||Inter-Quartile Range|Median
699827|NCT00023595|Secondary|H01:SF-36 Role Emotional Subscale|"These 3 items assess limitations and difficulty performing work or other usual activities as a result of any emotional problems (such as feeling depressed or anxious). Response choices are either Yes (1) or No (2). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better outcomes. (Final scores are normalized to a mean of 50 and standard deviation of 10.)"|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.||units on a scale||Standard Deviation|Mean
699828|NCT00023595|Secondary|H02: SF-36 Role Physical Subscale|"These 4 items assess limitations and difficulty performing work or other usual activities as a result of one's physical health. Response choices are either Yes (1) or No (2). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better outcomes. (Final scores are normalized to a mean of 50 and standard deviation of 10.)"|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.||units on a scale||Inter-Quartile Range|Median
699829|NCT00023595|Secondary|H01:SF-36 Role Physical Subscale|"These 4 items assess limitations and difficulty performing work or other usual activities as a result of one's physical health. Response choices are either Yes (1) or No (2). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better outcomes. (Final scores are normalized to a mean of 50 and standard deviation of 10.)"|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.||units on a scale||Standard Deviation|Mean
699830|NCT00023595|Secondary|H02: SF-36 Mental Health Subscale|"These 5 items assess anxiety, depression, emotional control, and psychological well-being. Response choices range from All of the time (1) to None of the time (6). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better mental health. (Final scores are normalized to a mean of 50 and standard deviation of 10.)"|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.||units on a scale||Inter-Quartile Range|Median
699831|NCT00023595|Secondary|H01: SF-36 Mental Health Subscale|"Short Form 36 Health Status Questionnaire (SF-36) Mental Health Subscale: These 5 items assess anxiety, depression, emotional control, and psychological well-being. Response choices range from All of the time (1) to None of the time (6). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better mental health. (Final scores are normalized to a mean of 50 and standard deviation of 10.)"|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.||units on a scale||Standard Deviation|Mean
699832|NCT00023595|Secondary|H02: B-type Natriuretic Peptide (BNP)|B-type natriuretic peptide (BNP) by Neurohormonal/cytokine/genetic (NCG) core lab during follow-up|From randomization to 24 months follow-up|Only patients with BNP data at baseline or 4 months were analyzed.||pg/mL||Standard Deviation|Mean
699833|NCT00023595|Secondary|H01: B-type Natriuretic Peptide (BNP)|B-type natriuretic peptide (BNP) by Neurohormonal/cytokine/genetic (NCG) core lab during follow-up|From randomization to 24 months follow-up|Only patients with BNP data at baseline or 4 months were analyzed.||pg/mL||Standard Deviation|Mean
699834|NCT00023595|Secondary|H02: LVEF by CMR Core Lab During Follow-up|Left ventricular ejection fraction (LVEF) measured by cardiovascular magnetic resonance (CMR) core lab.|From randomization to 24 months follow-up|Only patients with CMR LVEF data at baseline, 4 months or 24 months were analyzed.||Percent ejection fraction||Standard Deviation|Mean
699835|NCT00023595|Secondary|H01: LVEF by CMR Core Lab During Follow-up|Left ventricular ejection fraction (LVEF) measured by cardiovascular magnetic resonance (CMR) core lab.|From randomization to 24 months follow-up|Only patients with CMR LVEF data at baseline, 4 months or 24 months were analyzed.||Percent ejection fraction||Standard Deviation|Mean
699836|NCT00023595|Secondary|H02: LVEF by RN Core Lab During Follow-up|Left ventricular ejection fraction (LVEF) measured by radionuclide (RN) core lab.|From randomization to 24 months follow-up|Only patients with RN LVEF data at Baseline, 4-months or 24-months were analyzed.||Percent ejection fraction||Standard Deviation|Mean
699837|NCT00023595|Secondary|H01: LVEF by RN Core Lab During Follow-up|Left ventricular ejection fraction (LVEF) measured by radionuclide (RN) core lab.|From randomization to 24 months follow-up|Only patients with RN LVEF data at Baseline, 4-months or 24-months were analyzed.||Percent ejection fraction||Standard Deviation|Mean
699838|NCT00023595|Secondary|H02: LVEF by ECHO Core Lab During Follow-up|Left ventricular ejection fraction (LVEF) measured by Echocardiography (ECHO) core lab|From randomization to 24 months follow-up|Only patients with ECHO LVEF data at baseline, 4 months or 24 months were analyzed.||Percent ejection fraction||Standard Deviation|Mean
699839|NCT00023595|Secondary|H01: LVEF by ECHO Core Lab During Follow-up|Left ventricular ejection fraction (LVEF) measured by Echocardiography (ECHO) core lab|From randomization to 24 months follow-up|Only patients with ECHO LVEF data at baseline, 4 months or 24 months were analyzed.||Percent ejection fraction||Standard Deviation|Mean
699840|NCT00023595|Secondary|H02: Exercise Duration|Record the total duration of exercise in minutes and seconds for patients performing the modified Bruce exercise treadmill test|From randomization to 24 months follow-up|Only patients with exercise duration data at baseline or 24 months were analyzed.||meters||Standard Deviation|Mean
699841|NCT00023595|Secondary|H01: Exercise Duration|Record the total duration of exercise in minutes and seconds for patients performing the modified Bruce exercise treadmill test|From randomization to 24 months follow-up|Only patients with exercise duration data at baseline or 24 months were analyzed.||minutes||Standard Deviation|Mean
699842|NCT00023595|Secondary|H02: 6 Minute Walk Distance||From randomization to 24 month follow-up|Only patients with 6-minute walk distance data at baseline, 4 months or 24 months were analyzed.||meters||Standard Deviation|Mean
699843|NCT00023595|Secondary|H01: 6 Minute Walk Distance||From randomization to 24 month follow-up|Only patients with 6-minute walk distance data at baseline, 4 months or 24 months were analyzed.||meters||Standard Deviation|Mean
699844|NCT00023595|Secondary|H01: All-cause (Unplanned and Elective) Hospitalization||10 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.||participants|||Number
699845|NCT00023595|Secondary|H02: All-cause (Unplanned and Elective) Hospitalization||5 years post randomization|The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.||participants|||Number
699846|NCT00023595|Secondary|H01: All-cause (Unplanned and Elective) Hospitalization||5 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.||participants|||Number
699847|NCT00023595|Secondary|H01: All-cause Mortality, Heart Transplant or LVAD|LVAD=Left Ventricular Assist Device|10 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.||participants|||Number
699848|NCT00023595|Secondary|H02: All-cause Mortality, Heart Transplant or LVAD||5 years post randomization|The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.||participants|||Number
699849|NCT00023595|Secondary|H01: All-cause Mortality, Heart Transplant or LVAD|LVAD=Left Ventricular Assist Device|5 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.||participants|||Number
699850|NCT00023595|Secondary|H01: All-cause Mortality or Revascularization (CABG or PCI)|CABG = coronary artery bypass grafting. For patients randomized to CABG or CABG +SVR group, this represents the repeat CABG received during follow-up. PCI = Percutaneous Coronary Intervention.|10 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.||participants|||Number
699851|NCT00023595|Secondary|H02: All-cause Mortality or Revascularization (CABG or PCI)|CABG = coronary artery bypass grafting. For patients randomized to CABG or CABG +SVR group, this represents the repeat CABG received during follow-up. PCI = Percutaneous Coronary Intervention.|5 years post randomization|The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.||participants|||Number
699898|NCT00025155|Secondary|Overall Survival|Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.|From study entry to death or last contact, up to 5 years of follow-up.|Eligible and treated participants.||Months||95% Confidence Interval|Median
699852|NCT00023595|Secondary|H01: All-cause Mortality or Revascularization (CABG or PCI)|CABG = coronary artery bypass grafting. For patients randomized to CABG or CABG +SVR group, this represents the repeat CABG received during follow-up. PCI = Percutaneous Coronary Intervention.|5 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.||participants|||Number
699853|NCT00023595|Secondary|H02: Stroke||5 years post randomization|The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.||participants|||Number
699854|NCT00023595|Secondary|H01: Stroke||10 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.||participants|||Number
699855|NCT00023595|Secondary|H01: Stroke||5 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.||participants|||Number
699856|NCT00023595|Secondary|H01: Cardiac Procedure: Implantable Cardioverter Defibrillator (ICD)||10 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.||participants|||Number
699857|NCT00023595|Secondary|H02: Cardiac Procedure: Implantable Cardioverter Defibrillator (ICD)||5 years post randomization|The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.||participants|||Number
699858|NCT00023595|Secondary|H01: Cardiac Procedure: Implantable Cardioverter Defibrillator (ICD)||5 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.||participants|||Number
699859|NCT00023595|Secondary|H01: Cardiac Procedure: Left Ventricular Assist Device (LVAD)||10 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.||participants|||Number
699860|NCT00023595|Secondary|H02: Cardiac Procedure: Left Ventricular Assist Device (LVAD)||5 years post randomization|The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.||participants|||Number
699861|NCT00023595|Secondary|H01: Cardiac Procedure: Left Ventricular Assist Device (LVAD)||5 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.||participants|||Number
699862|NCT00023595|Secondary|H01: Cardiac Procedure: Heart Transplant||10 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.||participants|||Number
699863|NCT00023595|Secondary|H02: Cardiac Procedure: Heart Transplant||5 years post randomization|The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.||participants|||Number
699864|NCT00023595|Secondary|H01: Cardiac Procedure: Heart Transplant||5 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.||participants|||Number
699865|NCT00023595|Secondary|H01: Heart Failure Hospitalization||10 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.||participants|||Number
699866|NCT00023595|Secondary|H02: Heart Failure Hospitalization||5 years post randomization|The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.||participants|||Number
699867|NCT00023595|Secondary|H01: Heart Failure Hospitalization||5 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.||participants|||Number
699868|NCT00023595|Secondary|H01: All-cause Mortality or Heart-failure Hospitalization||10 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.||participants|||Number
699869|NCT00023595|Secondary|H02: All-cause Mortality or Heart-failure Hospitalization||5 years post randomization|The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.||participants|||Number
699870|NCT00023595|Secondary|H01: All-cause Mortality or Heart-failure Hospitalization||5 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.||participants|||Number
699871|NCT00023595|Secondary|H02: All-cause Mortality Within 30 Days After Randomization||30 days post randomization|The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm||participants|||Number
699872|NCT00023595|Secondary|H01: All-cause Mortality Within 30 Days After Randomization||30 days post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.||participants|||Number
699873|NCT00023595|Secondary|H02: All-cause Mortality||up to 5 years|The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.||participants|||Number
699874|NCT00023595|Secondary|H01: Mortality or Cardiovascular Hospitalization||up to 10 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.||participants|||Number
699875|NCT00023595|Secondary|H01: Mortality or Cardiovascular Hospitalization||up to 5 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.||participants|||Number
699876|NCT00023595|Secondary|H01: Cardiovascular Mortality (Defined as Sudden Death or Death Attributed to Recurrent MI, HF, a Cardiovascular Procedure, Stroke, or Other Cardiovascular Etiology).||5 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.||participants|||Number
699877|NCT00023595|Secondary|H01: Cardiovascular Mortality (Defined as Sudden Death or Death Attributed to Recurrent MI, HF, a Cardiovascular Procedure, Stroke, or Other Cardiovascular Etiology).||10 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.||participants|||Number
699878|NCT00023595|Primary|H02: All-cause Mortality or Cardiovascular Hospitalization||5 years post randomization|The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.||participants|||Number
699879|NCT00023595|Primary|H01: All Cause Mortality||10 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.||participants|||Number
699880|NCT00023595|Primary|H01: All Cause Mortality||5 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.||participants|||Number
699881|NCT00023673|Secondary|Complete Response Rate at 3 Months After Therapy||From start of treatment until 3 months after completion of therapy||||||
699882|NCT00023673|Secondary|Partial Organ Tolerance Doses for Lung and Esophagus||From start of treatment to end of follow-up||||||
699883|NCT00023673|Secondary|Toxicity||From start of treatment to end of follow-up||||||
699884|NCT00023673|Primary|Percentage of Patients Who Survive at Least 12 Months|Null hypothesis: p<= 62.3% (the best arm of RTOG 94-10); alternative hypothesis: p>= 77.9%. Where p is the percentage of patients alive at at 12 months. Using a one-group chi-square test with alpha = 0.10, a sample size of 50 patients provides at least 87% power to detect a 25% or greater relative increase in the 12-month survival rate, or equivalently, an absolute increase of at least 15.6 percentage points (62.3 versus 77.9). If the point estimate is greater than 71.1% (upper bound), then the conclusion is that the 12-month survival rate from the new treatment significantly improved from 62.3%.|From registration to 1 year|Eligible patients at the MTD dose level who started protocol treatment.||percentage of participants||95% Confidence Interval|Number
699885|NCT00023673|Primary|Maximum Tolerated Dose (MTD) of Three-dimensional Conformal Radiation Therapy (3DRT), in Terms of Gy Per Fraction, Combined With Concurrent Chemotherapy|"Dose limiting toxicity (DLT) = Grade 3/4 non-hematologic toxicities (excluding nausea, vomiting, and alopecia) and Grade 4 hematologic toxicities. The DLT rate for this study was set at 40% based on RTOG (Radiation Therapy Oncolgy Group) study 94-10. No acute (within 90 days from start of 3DRT) DLT's in the first 5 patients (0/5) or the combination of one acute DLT in the first 5 patients (1/5) and none in the next 2 patients (0/2) was required to deem a given dose level to be acceptable. If at any time a Grade 5 toxicity (death) occurred, accrual would be suspended and the event reviewed by a study chair. At any given dose level, this design gives at least 90% confidence that the true acute DLT rate is less than 40% and the probability of not escalating when the true toxicity rate is 40% or higher is at least 83%.
Rating scale: 0 = not the MTD, 1 = MTD"|From start of treatment to 90 days|The first seven eligible patients who started protocol treatment at each dose level.||units on a scale|||Number
699886|NCT00023712|Primary|Objective Partial/Complete Tumor Response Based on the Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) Criteria|Number of participants who experienced an objective tumor response up to 5 years. Per RECIST version 1.0 criteria: each target lesion must be >= 20 mm when measured by conventional techniques, including palpation, plain x-ray, CT, and MRI, or >= 10 mm when measured by spiral CT. Complete Response is a disappearance of all target and non-target lesions. Partial Response is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions, taking as reference the baseline sum of LD.|From study entry until disease progression/intolerable toxicity/study withdrawal|||participants|||Number
699887|NCT00023712|Secondary|Progression-Free Survival||From study entry up to 5 years|||months||95% Confidence Interval|Median
699888|NCT00023712|Secondary|Overall Survival||From study entry, up to 5 years following disease progression|||months||95% Confidence Interval|Median
699889|NCT00023712|Primary|Frequency and Severity of Observed Adverse Events||Up to 5 years||||||
699890|NCT00023712|Primary|Tumor Response Duration||From study entry, up to 5 years|||months||Full Range|Median
699891|NCT00023764|Primary|Response Rate|The response probability will be estimated. The 95% confidence interval will be provided.|Up to 3 years|||participants|||Number
699892|NCT00024102|Secondary|Number of Participants With Grade 3, 4 or 5 Adverse Event at Least Possibly Related to Treatment.|"The National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Version 2.0 was used to evaluate toxicity.
Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life Threatening; Grade 5: Death."|Reported during protocol treatment after each cycle|||participants|||Number
699893|NCT00024102|Secondary|Overall Survival Rate at 2.4 Years|Percentage of patients who were alive at 2.4 years. This rate was estimated using the Kaplan Meier method.|Time from registration to death (up to 15 years)|OS used the intent-to-treat approach.||percentage of participants|||Number
699894|NCT00024102|Primary|Relapse-free Survival Rates at 2.4 Years|"Percentage of participants who were alive and relapse-free at time of analysis were counted as Alive without relapse at 2.4 years. Participants who had a first local recurrence, first distant metastasis or death from any cause were counted as relapse, first occurrence. These rates were estimated using the Kaplan Meier method"|randomization until date of first event, or date last known to be event free if no event was reported (up to 5 years)|RFS used the intent-to-treat approach||percentage of participants|||Number
699895|NCT00024167|Secondary|Overall Survival From Registration|Overall survival (OS) was computed using the number of months from the date of registration to the date of death. Participants still alive were censored at the last follow-up date. Kaplan-Meier methodology was used to evaluate OS.|Followed every 4 weeks from registration until death, up to 7 years.|||months||95% Confidence Interval|Median
699896|NCT00024167|Primary|Overall Survival From Randomization|Overall survival (OS) was computed using the number of months from the date of randomization to the date of death. Participants still alive were censored at the last follow-up date. Kaplan-Meier methodology was used to evaluate OS.|Followed every 4 weeks from randomization until death, up to 7 years.|||months||95% Confidence Interval|Median
699897|NCT00024258|Primary|Response Rate After Every 3 Courses During Treatment and Then Every 2-3 Months for 1 Year After Completion of Treatment||1 year|||participants|||Number
699915|NCT00025506|Secondary|Serum and Plasma Concentrations of Vascular Endothelial Growth Factor (VEGF) and bFGF||Up to 5 years||||||
699899|NCT00025155|Secondary|Progression Free Survival|"Progression-Free Survival is the period from study entry until disease progression, death or date of last contact, whichever occurs first.
Progression is defined as at least a 20% increase in the sum of the longest dimensions (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or a 50% increase in the LD taking as reference the smallest LD recorded since study entry in the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions, or global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or death due to disease without prior objective documentation of progression."|From study entry to disease progression, death or date of last contact, whichever occurs first. Every other cycle, up to 5 years of follow-up|Eligible and treated participants.||Months||95% Confidence Interval|Median
699900|NCT00025155|Primary|Frequency and Severity of Observed Adverse Effects||Every cycle until completion of study treatment up to 30 days after stopping study treatment||||||
699901|NCT00025155|Primary|Tumor Response|"Percentage of participants with complete and partial tumor response as assessed by the Gynecologic Oncology Group Response Evaluation Criteria in Solid Tumors (GOG RECIST) with one-sided 90% Confidence Interval.
Complete Response (CR), disappearance of all target and non-target lesions without evidence of new lesion; Partial Response (PR), >=30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD with no unequivocal progression of non-target lesions and no evidence of new lesion, or a 50% decrease in the LD in the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam with no unequivocal progression of non-target lesions and no evidence of new lesion. Complete or partial response requires confirmation at greater than or equal to 4 weeks from initial documentation."|Every other cycle until the completion of study treatment with an average of study treatment time as of 3 months.|Eligible and treated participants.||percentage of participants||90% Confidence Interval|Number
699902|NCT00025233|Secondary|Performance Status and Age||Baseline||||||
699903|NCT00025233|Secondary|Duration of Progression-free Survival||Period from study entry until disease progression, death or date of last contact, assessed up to 7 years||||||
699904|NCT00025233|Secondary|Overall Survival|The observed length of life from entry into the study to death or the date of last contact.|From study entry to death or last contact, up to 5 years.|Eligible and treated patients.||months||95% Confidence Interval|Median
699905|NCT00025233|Secondary|Tumor Response|Complete and Partial Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0|Every other 3-week treatment cycle|Eligible and treated patients.||percentage of participants||90% Confidence Interval|Number
699906|NCT00025233|Primary|Frequency and Severity of Adverse Effects as Assessed by National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0||Up to 7 years||||||
699907|NCT00025233|Primary|Progression-free Survival Greater Than 6 Months|Whether or not the patient survived progression-free for at least 6 months.|Every other 3-week treatment cycle|Eligible and Treated Patients||percentage of participants||90% Confidence Interval|Number
699908|NCT00025259|Secondary|Overall Survival|Probability of overall survival which is defined as the time from study entry to death from any cause. Patients alive where censored at last contact.|5 years|Arm V (RER with PD), has been excluded as there were no deaths observed by the Time Frame of 5 years. Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).||Probability of survival||95% Confidence Interval|Number
699909|NCT00025259|Secondary|Grade 3 or 4 Non-hematologic Toxicity|Occurrence of any grade 4 non-hematologic toxicity or grade 3 non-hematologic toxicity which doesn't respond to treatment within 7 days despite recommended therapy modification, or toxic death, which is any death primarily attributable to treatment. Grade 3 is defined to be severe or medically significant but not immediate life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 refers to toxicities with life-threatening consequences; urgent intervention indicated.|Protocol therapy: the overall duration of which is: (n=1684) an average of 137.3 days, median 133.0 days, interquartile range: 101.0, 164.0 days.|Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).||Number of participants|||Number
699910|NCT00025259|Secondary|Disease Response Assessed by Modified RECIST Criteria|Number of participants with complete response and very good partial response at the end of protocol therapy.|Protocol therapy: the overall duration of which is: (n=1527) an average of 137.1 days, median 133.0 days, interquartile range: 101.0, 164.0 days.|Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).||Number of participants|||Number
699911|NCT00025259|Primary|Event-free Survival|Probability of event-Free survival which is defined as the time from study entry to treatment failure (disease progression, disease recurrence, biopsy positive residual after completion of all protocol therapy), occurrence of a second malignant neoplasm, or death from any cause. Patients without report of such events where censored at last contact.|5 years|Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).||Probability of survival||95% Confidence Interval|Number
699912|NCT00017563|Primary|Number of Participants With 5-year Freedom From Prostate Specific Antigen (PSA) Recurrence.|Number of participants that experienced 5-year freedom from Prostate Specific Antigen (PSA) recurrence (PSA > 0.4 ng/ml confirmed by a second PSA that is higher than the first by any amount (2)) in men with high risk localized prostate cancer treated with neoadjuvant docetaxel/mitoxantrone followed by surgery.|Every 3 months after surgery for up to 5 years.|||participants|||Number
699913|NCT00018031|Primary|Participants With Viral Decline at Day 3 & 28 With Predictors of Post Treatment Response|"HCV viral kinetics were used to predict rates of sustained virology response (SVR) in HIV/HCV connected subjects.
Measure was determined by analyzing the population of participants with virologic decline of more than 1.0 log at day 3 combined with viral load of less than 5.0 log IU/ml at day 28 to predict sustained virology response"|Day 3 and Day 28|Participants with Virologic decline at both Day 3 and absolute HCV VL at Week 28 were analyzed||participants with post treatment svr|||Number
699914|NCT00025506|Secondary|Serum and Plasma Concentrations of VEGF and bFGF With PFS||Up to 5 years||||||
699916|NCT00025506|Secondary|Initial Performance Status and Histological Grade||Up to 5 years||||||
699918|NCT00025506|Secondary|Tumor Response|Complete and Partial Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0|For those patients whose disease can be evaluated by physical examination, response was assessed prior to each 28-day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle.|Eligible and treated patients.||percentage of participants||90% Confidence Interval|Number
699919|NCT00025506|Primary|Frequency and Severity of Adverse Effects as Assessed by Common Toxicity Criteria (CTC) v2.0||Up to 5 years||||||
699920|NCT00025506|Secondary|Progression Free Survival||For those patients whose disease can be evaluated by physical examination, progression was assessed prior to each 28-day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle||||||
699921|NCT00025506|Primary|Progression-free Survival (PFS) > 6 Months|Whether or not the patient survived progression-free for at least 6 months.|For those patients whose disease can be evaluated by physical examination, progression was assessed prior to each 28-day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle|Eligible and treated patients.||percentage of participants||90% Confidence Interval|Number
699922|NCT00025662|Other Pre-specified|Acute GVHD (Grade 3 or 4) Using the CIBMTR Grading System.||100 days from transplant|All 22 patients who received the selectively depleted transplant||percentage of participants|||Number
699923|NCT00025662|Other Pre-specified|Acute GVHD (Any Grade) Using the CIBMTR Grading System.|Proportion of patients with acute GVHD, grade 1 to 4|100 days from transplant|All 22 subjects who received the selectively depleted transplant||percentage of participants||95% Confidence Interval|Number
699924|NCT00025662|Secondary|Cumulative Non Relapse Mortality|Percent non relapse mortality (actuarial) at analysis in Dec 2011|Dec 2011.|All patients who received the selectively depleted transplant||percentage of participants||95% Confidence Interval|Number
699925|NCT00025662|Secondary|Overall Survival|Percent overall survival (actuarial) at analysis in Dec 2011.|Dec 2011.|all patients who received the selectively depleted transplant including one special exemption||percentage of participants||95% Confidence Interval|Number
699926|NCT00025662|Primary|Treatment-related Mortality|"Nonrelapse mortality in the first 100 days of transplant expressed as a percentage of the total subjects.
This is different from outcome measure 3 (Cumulative Nonrelapse Mortality), which is cumulative non relapse mortality till December 2011."|100 days after stem cell infusion|all 22 patients who received a selectively depleted allogeneic transplant, including one who was a special exemption for not meeting full eligibility criteria||percentage of participants||95% Confidence Interval|Number
699927|NCT00027378|Primary|Depressive Symptoms|Beck Depression Inventory (BDI) Scores measured at Weeks 1-4, 6, 8, 10, 12. The BDI is a subject reported measure that has a minimum score of 0 and a maximum score of 63. A better outcome would consist of values near the minimum end of the scale (0) and a worse outcome would consist of values near the maximum end of the scale (63).|Average score as measured by participant's report on the Beck Depression Inventory (BDI).|||units on a scale||Standard Deviation|Mean
699928|NCT00027378|Primary|Alcohol Use Behaviors|Alcohol use behaviors measured by drinks per week.|Average number of drinks as recorded on the Timeline Follow-Back (subject-reported) measure daily over the 12-week acute phase.|Participants were randomized to either fluoxetine-treated or placebo.||standard drink (14 gr. alcohol)||Standard Deviation|Mean
699929|NCT00027560|Secondary|Extensive Chronic Graft-versus-Host Disease Unrelated and Mismatched Related Patients||up to 2 years post transplant|The number of unrelated and mismatched patients was analyzed as per protocol.||participants|||Number
699930|NCT00027560|Secondary|Extensive Chronic Graft-versus-Host Disease Matched Related Patients||up to 2 years post transplant|The number of matched related patients was analyzed as per protocol.||participants|||Number
699931|NCT00027560|Secondary|Acute Graft-versus-Host Disease Unrelated and Mismatched Related Patients|Grade III-IV Acute Graft-versus-Host Disease|up to 4 months post transplant|The number of unrelated and mismatched patients was analyzed as per protocol.||participants|||Number
699932|NCT00027560|Primary|Acute Graft-versus-Host Disease Matched Related Patients|Grade III-IV Acute Graft-versus-Host Disease|up to 4 months post transplant|The number of matched related patients was analyzed as per protocol.||participants|||Number
699933|NCT00027560|Primary|Overall Survival||24 months post transplant|Population is defined as all participants who received transplant as per protocol.||participants|||Number
699934|NCT00027560|Primary|Overall Survival||12 months post transplant|Population is defined as all participants who received transplant as per protocol.||participants|||Number
699935|NCT00027846|Secondary|Local Control and Patterns of Failure|Documented and analyzed qualitatively and quantitatively.|Up to 5 years after completion of study treatment|All eligible patients in the study were included.||Participant|||Number
699936|NCT00027846|Secondary|Event-free Survival (EFS)|EFS between centrally reviewed differentiated ependymoma and anaplastic ependymoma for the patients who were treated with radiation therapy only. The event-free survival (EFS) defined as the time to disease progression, disease relapse, occurrence of a second neoplasm, or death from any cause, measured from the start of radiation therapy. The product-limit (Kaplan-Meier) estimate is for estimation of EFS probability at 5 years.|At 5 years since the time of radiation therapy|Supratentorial Anaplastic Ependymoma (GTR1, GTR2, NTR) and Anaplastic or Differentiated Infratentorial Ependymoma (GTR1, GTR2, NTR) and Supratentorial Differentiated Ependymoma(GTR2, NTR). Patients undergo conformal radiation therapy to the brain once daily 5 days a week for 6-6½ weeks.||Probability of EFS at 5 years||95% Confidence Interval|Number
699937|NCT00027846|Secondary|Event-free Survival (EFS)|EFS between centrally reviewed differentiated ependymoma and anaplastic ependymoma for the patients who had sub-total resection initially. The event-free survival (EFS) defined as the date of disease progression, disease relapse, occurrence of a second neoplasm, or death from any cause, measured from the start date of radiation therapy. The product-limit (Kaplan-Meier) estimate is for estimation of EFS probability.|At 5 years since the time of radiation therapy.|Of 64 eligible patients who had initial subtotal resection, 5 patients were off-therapy prior to radiation therapy, and 4 patients had a disease progression prior to radiation therapy. There were 55 eligible patients included in the analysis. The product-limit (Kaplan-Meier) estimate is for estimation of EFS probability.||Probability of EFS at 5 years||95% Confidence Interval|Number
699938|NCT00027846|Secondary|Rate of Gross-total or Near-total Resection and Second Surgery After Chemotherapy|The Rate Of Gross-Total or Near-Total Resection With Second Surgery After Chemotherapy Treatment.|At the time of second surgery|Of 64 eligible patients in this group, 25 patients after chemotherapy had the second surgery. Of 25 patients with second surgery after chemotherapy, 19 had a Gross-Total or Near-Total resection. 19/25=76%.||percentage of participants||95% Confidence Interval|Number
699939|NCT00027846|Secondary|Overall Survival|Overall survival (OS) is measured from the date of study enrollment to the date to death. The product-limit (Kaplan-Meier) estimate is for estimation of OS probability at 5 years.|Up to 5 years after completion of study treatment|All eligible patients in the study were included. The product-limit (Kaplan-Meier) estimate is for estimation of OS probability.||Probability of OS at 5 years||95% Confidence Interval|Number
699940|NCT00027846|Primary|Event-free Survival|Event-free survival is calculated from the date of study enrollment to the date of disease progression, disease relapse, occurrence of second neoplasm, or death from any cause. The product-limit (Kaplan-Meier) estimate is for estimation of Event -free survival (EFS) probability at 5 years.|Up to 5 years after completion of study treatment|The product-limit (Kaplan-Meier) estimate is for estimation of event-free survival probability at 5 years. All eligible patients in the study were included.||Probability of EFS at 5 years||95% Confidence Interval|Number
699941|NCT00028002|Primary|Change in Biological Markers of Imatinib Mesylate, Including C-kit and Tyrosine||to be entered||||||
699942|NCT00028002|Primary|Incidence of Adverse Events Grade 3 or Greater Graded According to NCI Common Toxicity Criteria (CTC) Version 2.0 (i.e., Major Toxicity)|The major toxicity rates along with their 95% confidence intervals will be estimated using a binomial distribution.|Up to 5 years||||||
699943|NCT00028002|Primary|Rates of Objective Response (Complete, Partial, and Stable)|The response rates along with their 95% confidence intervals will be estimated using a binomial distribution.|Up to 5 years||||||
699944|NCT00028002|Primary|Rate of Disease Progression at 2 Years|Kaplan-Meier estimate of disease progression rate. Disease progression is determined by RECIST criteria (Response Evaluation Criteria in Solid Tumours). (RECIST criteria described here: http://ctep.cancer.gov/protocolDevelopment/docs/recist_guideline.pdf)|From registration to two years|All eligible patients.||percentage of participants||95% Confidence Interval|Number
699945|NCT00028093|Primary|Change in Hepatitis C Virus RNA Levels During Phase I||From day 0 to day 3|||log(IU/mL)||Full Range|Median
699946|NCT00028262|Primary|Change in Cellular Granular Osmiophilic Deposits (GRODs) in Electron Micrographs of Peripheral White Blood Cells.|The GRODs in peripheral white blood cells from all patients before and during treatment were analyzed by transmission electron microscopy (TEM) at 30000xmagnification. Two investigators working independently of each other identified and counted the GRODs and the results were averaged.|10 years|Out of 10 enrolled subjects, one subject did not complete study and was lost to follow up.||Average number of GRODs||95% Confidence Interval|Mean
699947|NCT00028769|Primary|Overall Survival (OS)|Overall survival is defined from the date of registration to date of death from any cause|0-5 years|All eligible patients who started treatment were included in the analysis||months||95% Confidence Interval|Median
699948|NCT00028769|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 2.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|up to 5 years after registration|Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 2.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.||Participants|||Number
699949|NCT00028769|Primary|Progression-free Survival|Measured from time of registration to time of first documentation of progression determined from the prostate-specific antigen (PSA) level, clinical criteria, or symptomatic deterioration. PSA progression is defined as a 25% increase greater than baseline. If the patient's PSA level had decrease during the study, a 25% increase from the nadir PSA level, with absolute value of >=5 ng/mL is considered progression. CLinical progress is defined as the appearance of any new lesion at any site or death without documented progression. Symptomatic deterioration is defined as a global deterioration of the health status requiring discontinuation of treatment without objective evidence of progression.|0-5 years (assessed every 3 months if no progression when the chemotherapy had been finished. Once off chemotherapy, assessed every 3 months until progression)|All eligible patients who started treatment were included in the analysis||months||95% Confidence Interval|Median
699950|NCT00029107|Primary|Percent of Patients in Remission|The primary endpoint was the difference in rate of remission between the 2 arms at 6 months from study entry.|month 6|||percent of participants||95% Confidence Interval|Number
699951|NCT00029146|Other Pre-specified|Any Stroke or Death Within 30 Days After Surgery||within 30 days after surgery|Intention-to-treat. All assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy||participants|||Number
699952|NCT00029146|Secondary|Ipsilateral Ischemic Stroke in 2 Yrs From Randomization and All Stroke & Death Through 30d Post-surgery; Non-surgical Group:Ipsilateral Ischemic Stroke in 2 Yrs From Randomization and All Stroke & Death Through 30d Post-randomization|2 yr Kaplan-Meier estimates of the proportions.Proportions expressed as percentages for reporting purposes. Ipsilateral ischemic stroke is defined as the clinical diagnosis of a focal neurological deficit due to cerebral ischemia clinically localizable within the internal carotid artery territory distally to the symptomatic occluded internal carotid artery that lasts for more than 24 hours. All stroke is defined as the clinical diagnosis of a focal deficit due to ischemia or hemorrhage clinically localizable to the brain that lasts for more than 24 hours. Death is of any cause.|within 2 years of randomization|On-treatment analysis removing four participants assigned to the surgical group who never underwent surgery and censoring on the day of surgery three participants assigned to the nonsurgical group who underwent EC-IC bypass surgery.||percentage of participants||95% Confidence Interval|Number
699953|NCT00029146|Secondary|Summary SS-QOL Score|Summary Stroke Specific Quality of Life score (1-4) askes how self-reported overall quality of life compares with with that before stroke. A higher score indicates is better.|at 2 years after randomization or end of trial. Worst case imputed for death and missing values|Intention to treat principle.All participants analyzed in the group to which they were originally randomized.||units on a scale||95% Confidence Interval|Mean
699954|NCT00029146|Secondary|Modified Barthel Index 19-20|Modified Barthel Index dichotomized 19-20 vs <= 18. The modifed Barthel Index(0-20) describes the degree of independence in day-to-day self-care activities. A higher score indicates greater independence.|at 2 years after randomization or end of trial. Worst case imputed for death and missing values|Intention to treat principle.All participants analyzed in the group to which they were originally randomized.||percentage of participants|||Number
699955|NCT00029146|Secondary|Modified Rankin 0-2|Proportion with Modified Rankin score at 2 yrs, dichotomized 0-2 vs 3-6. The modifed Rankin (0-6) describes the degree of functional disability. A lower score indicates less functional disability.|at 2 years after randomization or end of trial. Worst case imputed for death and missing values|Intention to treat principle.All participants analyzed in the group to which they were originally randomized.||percentage of participants||95% Confidence Interval|Number
699956|NCT00029146|Secondary|Modified Rankin 0-1|Proportion with modified Rankin score, dichotomized 0 or 1 vs 2-6.The modifed Rankin (0-6) describes the degree of functional disability. A lower score indicates less functional disability.|at 2 years after randomization or end of trial. Worst case imputed for death and missing values|Intention to treat principle.All participants analyzed in the group to which they were originally randomized.||percentage of participants||95% Confidence Interval|Number
699957|NCT00029146|Post-Hoc|Any Stroke or Death|2 yr Kaplan-Meier estimates of the proportions. Any stroke is defined as the clinical diagnosis of a focal deficit due to ischemia or hemorrhage clinically localizable to the brain that lasts for more than 24 hours. Death is of any cause.|within 2 years after randomization|Intention to treat principle.All participants analyzed in the group to which they were originally randomized.||percentage of participants||95% Confidence Interval|Number
699958|NCT00029146|Secondary|Death|2 yr Kaplan-Meier estimates of the proportions. Death of any cause|within 2 years after randomization|Intention to treat principle.All participants analyzed in the group to which they were originally randomized.||percentage of participants||95% Confidence Interval|Number
699959|NCT00029146|Secondary|Fatal Stroke|2 yr Kaplan-Meier estimates of the proportions. Fatal stroke is a stroke that in the investigator’s opinion led directly to the participants death within 30 days of occurrence|within 2 years after randomization|Intention to treat principle.All participants analyzed in the group to which they were originally randomized.||percentage of participants||95% Confidence Interval|Number
699960|NCT00029146|Secondary|Disabling Stroke|2 yr Kaplan-Meier estimates of the proportions. Disabling stroke is defined as a modified Barthel Index of <12/20 at the first scheduled return visit more than 3 months after the stroke occurred|within two years after randomization|Intention to treat principle.All participants analyzed in the group to which they were originally randomized.||percentage of participants||95% Confidence Interval|Number
699961|NCT00029146|Secondary|All Stroke|2 yr Kaplan-Meier estimates of the proportions. All stroke is defined as the clinical diagnosis of a focal deficit due to ischemia or hemorrhage clinically localizable to the brain that lasts for more than 24 hours|within 2 yrs of randomization|Intention to treat principle.All participants analyzed in the group to which they were originally randomized.||percentage of participants||95% Confidence Interval|Number
699962|NCT00029146|Primary|Surgical Group:Ipsilateral Ischemic Stroke in 2 Yrs From Randomization and All Stroke & Death Through 30d Post-surgery; Non-surgical Group:Ipsilateral Ischemic Stroke in 2 Yrs From Randomization and All Stroke & Death Through 30d Post-randomization|2 yr Kaplan-Meier estimates of the proportions.Proportions expressed as percentages for reporting purposes. Ipsilateral ischemic stroke is defined as the clinical diagnosis of a focal neurological deficit due to cerebral ischemia clinically localizable within the internal carotid artery territory distally to the symptomatic occluded internal carotid artery that lasts for more than 24 hours. All stroke is defined as the clinical diagnosis of a focal deficit due to ischemia or hemorrhage clinically localizable to the brain that lasts for more than 24 hours. Death is of any cause.|within 2 yrs of randomization|Intention to treat principle.All participants analyzed in the group to which they were originally randomized.||percentage of participants||95% Confidence Interval|Number
699963|NCT00029172|Primary|Twelve Week Depression Outcomes|"Depression remission was defined as HAM-D less than 8 or HAM-D decreased by 50%.
The Hamilton Rating Scale for Depression is measured on a scale from no depression - major depression, 0-52 units on a scale."|Twelve week|||HAM-D depression score||Standard Deviation|Mean
699964|NCT00029536|Secondary|Change in Serum Levels of Antiepileptic Drugs on Progesterone and Placebo for Subjects With Catamenial and Non-catamenial Epilepsy.||9 years|||mcg/mL||Standard Deviation|Mean
699965|NCT00029536|Secondary|Changes in Serum Progesterone Levels in Subjects at Baseline and After Treatment.|Changes in serum progesterone levels in subjects at baseline and after treatment with progesterone or placebo.|9 years|||ng/ml||Inter-Quartile Range|Median
699966|NCT00029536|Secondary|Percentage of Women Who Show a Greater Than 50% Decline in Average Daily Seizure Frequency for Secondary Generalized, Complex Partial and Simple Partial Seizures Considered Separately|Percentage of women who show a greater than 50% decline in average daily seizure frequency for secondary generalized, complex partial and simple partial seizures considered separately|9 years|||percentage of participants|||Number
699967|NCT00029536|Secondary|Percent of Women Who Show a >50% Decline in Average Daily Seizure Frequency for the Most Severe Seizure Type.|Percent of women who show a >50% decline in average daily seizure frequency for the most severe seizure type.|9 years|||percentage of participants|||Number
699968|NCT00029536|Primary|Percent of Women Who Show a Greater Than 50% Decline in Average Daily Seizure Frequency|Percent of women who show a greater than 50% decline in average daily seizure frequency|9 years|||percentage of participants|||Number
699976|NCT00022633|Secondary|Overall Confirmed Response Rate in the Patients Age 70 and Older (Complete and Partial Response)|Complete response (CR) is defined as complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Partial response (PR) applies only to patients with least one measurable lesion. Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions.|every week for the first 4 weeks and then every 3 weeks for up to 19 weeks|Eligible patients aged 70 years and older who had received any treatment were included in the analysis. Patients aged 60 years or younger who served as a younger reference group for the pharmacokinetic study were excluded from analysis.||percentage of participants||95% Confidence Interval|Number
706134|NCT00105157|Secondary|Number of Patients Discontinued With Laboratory Adverse Experiences (LAEs) at 48 Weeks||48 weeks|All patients who took study medication and had any laboratory tests performed were included in the analysis.||Participants|||Number
699969|NCT00022633|Secondary|Assess the Feasibility of Patient-reported Outcome Measures for Patients Aged 70 Years and Older: at Least One Type of Assistance Required|Patients were required to complete three self-administered questionnaires at entry, prior to the administration of any cytotoxic therapy: the Medical Conditions Questionnaire, Instrumental Activities of Daily Living Form that evaluates functional status, and the Feelings Questionnaire that evaluates depression status. Feasibility is defined in four ways: 1) submission rates for the three patient self-administered questionnaires (> 60%); 2) the number of items missing within each scale (< 5%); 3) a description of the level of assistance required for self-administration of the questionnaires; and 4) the average amount of time it takes patients to complete each of the three questionnaires. Level of assistance is defined as the need to 1) read the questionnaire to the patient, 2) explain the meaning of items, 3) explain the response format, and 4) complete the questionnaire for the patient; an other category of assistance will be included.|at study entry (prior to administration of any treatment)|Eligible patients aged 70 years and older who had received any treatment were included in the analysis. One non-compliant patient who did not complete any of the forms was excluded. Patients aged 60 years or younger who served as a younger reference group for the pharmacokinetic study were excluded from analysis.||percentage of participants|||Number
699970|NCT00022633|Secondary|Feasibility of Patient-reported Outcome Measures for Patients Aged 70 Years and Older: Median Time of Complete Forms|Patients were required to complete three self-administered questionnaires at entry, prior to the administration of any cytotoxic therapy: the Medical Conditions Questionnaire, Instrumental Activities of Daily Living Form that evaluates functional status, and the Feelings Questionnaire that evaluates depression status. Feasibility is defined in four ways: 1) submission rates for the each of three patient self-administered questionnaires (> 60%); 2) the number of items missing within each scale (< 5%); 3) a description of the level of assistance required for self-administration of the questionnaires; and 4) the average amount of time it takes patients to complete each of the three questionnaires. Level of assistance is defined as the need to 1) read the questionnaire to the patient, 2) explain the meaning of items, 3) explain the response format, and 4) complete the questionnaire for the patient; an other category of assistance will be included.|at study entry (prior to administration of any treatment)|Eligible patients aged 70 years and older who had received any treatment were included in the analysis. One non-compliant patient who did not complete any of the forms was excluded. Patients aged 60 years or younger who served as a younger reference group for the pharmacokinetic study were excluded from analysis.||minutes||Full Range|Median
699971|NCT00022633|Secondary|Feasibility of Patient-reported Outcome Measures for Patients Aged 70 Years and Older: Form Submission Rate|Patients were required to complete three self-administered questionnaires at entry, prior to the administration of any cytotoxic therapy: the Medical Conditions Questionnaire, Instrumental Activities of Daily Living Form that evaluates functional status, and the Feelings Questionnaire that evaluates depression status. Feasibility is defined in four ways: 1) submission rates for each of three patient self-administered questionnaires (> 60%); 2) the number of items missing within each scale (< 5%); 3) a description of the level of assistance required for self-administration of the questionnaires; and 4) the average amount of time it takes patients to complete each of the three questionnaires. Level of assistance is defined as the need to 1) read the questionnaire to the patient, 2) explain the meaning of items, 3) explain the response format, and 4) complete the questionnaire for the patient; an other category of assistance will be included.|at study entry (prior to administration of any treatment)|Eligible patients aged 70 years and older who had received any treatment were included in the analysis. Patients aged 60 years or younger who served as a younger reference group for the pharmacokinetic study were excluded from analysis.||percentage of participants|||Number
699972|NCT00022633|Primary|Determine the Feasibility of Accruing Patients With Metastatic Bladder Cancer Who Are 70 and Older to Chemotherapy Protocols|Sixty patients aged 70 years and older were to be accrued to the study. The feasibility of accrual was determined that accrual of 3 patients per month in the age 70 and older range would allow for an expeditiously conducted phase II trial. If, after a 3 month start-up period, 3 or more patients aged 70 years and older were accrued per month for the duration of the trial, it was deemed reasonable to consider further trials in this elderly population.|66 months (protocol activated on 7/1/2001 and closed to accrual on 12/15/2006)|A total of 55 patients aged 70 years and older were registered to this protocol from July, 2001 to December, 2006.||participants|||Number
699973|NCT00022633|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 2.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment.|Eligible patients aged 70 years and older who had received any treatment were included in the adverse event summaries. Any CTCAE 2.0 event of Grade 3, Grade 4, or Grade 5 which deemed to be related to protocol treatment are included. Patients aged 60 years or younger who served as a younger reference group for the pharmacokinetic study are excluded||Participants|||Number
699974|NCT00022633|Secondary|Overall Survival (OS) in Patients Aged 70 Years and Older|Measured from date of registration to date of death due to any cause.|0-5 years|Eligible patients aged 70 years and older who had received any treatment were included in the analysis. Patients aged 60 years or younger who served as a younger reference group for the pharmacokinetic study were excluded from analysis.||months||95% Confidence Interval|Median
699975|NCT00022633|Secondary|Progression-free Survival in Patients Aged 70 Years and Older|Measured form date of registration to date of first observation of progression disease, death due to any cause, symptomatic deterioration, or early discontinuation of treatment.|0-5 years|Eligible patients aged 70 years and older who had received any treatment were included in the analysis. Patients aged 60 years or younger who served as a younger reference group for the pharmacokinetic study were excluded from analysis.||months||95% Confidence Interval|Median
699994|NCT00033293|Primary|Number of Responders|A multi-stage design followed by a test of proportions between the treatment arms (chemo vs. chemo + therapeutic immune globulin (IVIG)) will be performed. The first stage of the multi-stage design will also function as an early stopping rule for insufficient activity of chemotherapy in OMA.|Changes from baseline to 2 months, 6 months, and 1 year|Eligible patients||participants|||Number
725195|NCT00351273|Secondary|Comparison of Erythrocyte Sedimentation Rate (ESR) and C-reactive Protein (CRP)||Month 6||||||
699977|NCT00030147|Primary|Center for Epidemiologic Studies–Depression Scale (CES-D)|Center for Epidemiologic Studies–Depression Scale (CES-D) cutoff scores are typically used as a screen to identify clinically significant depression; a cutoff score of greater than 16 has been shown to correlate with clinically significant depression. In addition, a score between 8 and 15 has been used to define subsyndromal depression. The possible range of scores is zero to 60, with the higher scores indicating more symptoms, weighted by frequency of occurrence during the past week.|Week 8|The analyses included those subjects who completed eight weeks of study||Units on a scale||Standard Deviation|Mean
699978|NCT00030147|Primary|Center for Epidemiologic Studies–Depression Scale (CES-D)|Center for Epidemiologic Studies–Depression Scale (CES-D) cutoff scores are typically used as a screen to identify clinically significant depression; a cutoff score of greater than 16 has been shown to correlate with clinically significant depression. In addition, a score between 8 and 15 has been used to define subsyndromal depression. The possible range of scores is zero to 60, with the higher scores indicating more symptoms, weighted by frequency of occurrence during the past week.|Baseline|The analyses included those subjects who started the study.||Units on a scale||Standard Deviation|Mean
699979|NCT00032487|Secondary|Secondary Endpoint|New or worsening angina, new transient ischemic attack (TIA), new intermittent claudication or critical limb ischemia with Doppler evidence or total mortality.|Post baseline time to first event up to 82 months|||participants|||Number
699980|NCT00032487|Primary|Primary Major Macrovascular Events|Myocardial infarction (MI), intervention for coronary artery or Peripheral Vascular Disease (PVD), severe inoperable Coronary Artery Disease (CAD), new or worsening Congestive Heart Failure (CHF), stroke, Cardiovascular (CV) death, or amputation for ischemic gangrene.|Post baseline time to the first major macrovascular event up to 82 months|||participants|||Number
699981|NCT00032591|Secondary|Health Care Costs at 2 Year||After 2 years of follow-up for each subject|Randomized participants with at least one day of follow-up, per intent to treat||U.S. Dollars||Standard Deviation|Mean
699982|NCT00032591|Secondary|Cumulative Gain in Health Utilities at 2 Year|Scores range from -0.36 to 1.00 per year, with a negative score indicating a state worse than being dead and a score of 1.00 indicating perfect health. Since the time frame is 2 years, the range is -0.72 to 2.00.|After 2 years of follow-up for each subject|Randomized participants with at least one day of follow-up, per intent to treat||score||Standard Deviation|Mean
699983|NCT00032591|Secondary|DASS at 2 Years of Follow-up|Satisfaction with care was quantified using the Duke Anticoagulation Satisfaction Scale (DASS). Scores range from 25 to 225, with lower scores indicating higher satisfaction.|At two years of follow-up|Randomized participants with at least one day of follow-up, per intent to treat||score||Standard Deviation|Mean
699984|NCT00032591|Secondary|Time in Therapeutic Range Over Full Length of Follow-up (0 to 100 Percent)|Time in target range (TTR) based on Prothrombin Time standardized to the International Normalized Ratio|Full length of follow-up; average of 3 years|Randomized participants with at least one day of follow-up, per intent to treat||percentage||Standard Deviation|Mean
699985|NCT00032591|Primary|Time to First Event (Death, Stroke, Major Bleed)|"Time to first event (death, stroke, major bleed)
The primary outcome was time to first event, and we used the Kaplan-Meier method to compare survival curves and the results using the log-rank test. The number of patients with a primary outcome is what was reported in the NEJM paper. Below is the unpublished cumulative incidence information."|Time to event|Randomized participants with at least one day of follow-up, per intent to treat||cumulative probability of event||95% Confidence Interval|Number
699986|NCT00032630|Primary|Long-term Composite|Long-term composite endpoint was death from any cause within 1 year, nonfatal myocardial infarction between 30 days and 1 year, or repeat revascularization between 30 days and 1 year.|one-year|||Participants|||Number
699987|NCT00032630|Primary|Short-term End Point|Short-term end point was a composite of death or major complications (reoperation, new mechanical support, cardiac arrest, coma, stroke, or renal failure requiring dialysis) occuring within 30 days after surgery or before discharge, whichever was later.|30 day|||participants|||Number
699988|NCT00033293|Secondary|Tumor Outcome in Terms of Overall Survival (OS) Rate|OS rate from time of study enrollment.|Up to 3 years|All eligible randomized patients.||3 year OS||95% Confidence Interval|Number
699989|NCT00033293|Secondary|Tumor Outcome in Terms of Event-free Survival (EFS) Rate Defined as a Relapse or Progression of Neuroblastoma, a Second Malignancy, or Death|EFS rate for neuroblastoma event from time of study enrollment.|Up to 3 years|All eligible randomized patients.||3 year EFS||95% Confidence Interval|Number
699990|NCT00033293|Secondary|Long-term Prognosis for Neurologic Recovery by Neurological Examination|A t-test will be performed on the results of each neurologic test, comparing patients who have had disappearance of anti-neural antibodies to patients whose anti-neural antibodies have not disappeared.|At diagnosis and yearly for 10 years after diagnosis|The data is not available at this time. Investigators have not finished analyzing the specimens or reviewing the patient study data required to evaluate this study objective.|||||
699991|NCT00033293|Secondary|Biology of Neuroblastoma Associated Opsoclonus-myoclonus-ataxia (OMA) Syndrome Specifically by MRI Findings, Anti-neuronal Antibodies, Cerebrospinal Fluid (CSF) Findings and Tumor Biology|Descriptive analyses on biologic variables will be performed|At diagnosis, 6 months, 1 year, 5 and 10 years after diagnosis|The data is not available at this time. Investigators have not finished analyzing the specimens or reviewing the patient study data required to evaluate this study objective.|||||
699992|NCT00033293|Secondary|Functional Outcome as Assessed by Age-appropriate Neuropsychological Testing|"The Bayley Scales of infant development mental scale best score of two time points will be used in the analysis. For a given patient, this score will be used to calculate the change from baseline."|Changes from baseline to the better of 6 months or 1 year|All eligible patients who had Bayley's measures at diagnosis and at least one of 6 months or 1 year.||Change in Bayley's score||Standard Deviation|Mean
699993|NCT00033293|Secondary|Motor Coordination as Assessed by Neurological Examination and Vineland Adaptive Behavior Scale (VABS)|"The best score at the two time points will be used in this analysis. For a given patient, this best score will be used to calculate the change from baseline. The mean change from baseline for each treatment group will be calculated."|Changes from baseline to the better of 6 months or 1 year|All eligible patients who had VABS measures at diagnosis and at least one of 6 months or 1 year.||Change in VABS score||Standard Deviation|Mean
725196|NCT00351273|Secondary|"Individual Comparison of 6 Responder Criteria in the Combination Antimicrobial Groups Versus the Placebo Group"||Months 6 and 9||||||
699999|NCT00033371|Primary|Percent Change in the Number of Polyps Greater Than or Equal to 2mm in Diameter in Focal Area(s) of the Colorectum|Differences between average treatment effects of two study arms tested using two-sided type I error rate of 5% in two-sample t-test. If model assumptions not met by data or transformations of data, appropriate nonparametric tests (e.g. Wilcoxon rank sums test) were used to compare treatment arms - Percent change of polyp counts from baseline to 6 months, ie [(6 months - baseline) x 100]/baseline (%). For each participant, first were matched polyps between baseline & 6 months by region and landmark and summed over all matched regions on number of polyps >2 mm to calculate total number of polyps >2 mm at baseline & 6 months, respectively. For participants refusing exit colonoscopy, 0% change entered as primary endpoint. Defined ITT All: All patients; if 6-month polyp counts missing = 0% change; ITT Measurable: All participants with baseline & 6 month polyp counts; ITT Evaluable: ITT Measurable participants who also took 80% of treatment, both overall as well as during final 60 days.|Baseline up to 6 months|Analysis was by intent to treat (ITT) with a total of 89 ITT participants measurable by having complete polyp information.||percentage change in polyp count||Standard Error|Mean
700000|NCT00033514|Primary|Recommended Dose for Phase II||treatment period|patients who have not experienced specific adverse events, dose will be escalated to 150 mg daily. Patients who have experienced specific adverse events dose will remain 100 mg daily or dose reduced as necessary per protocol.||participants receiving each dose|||Number
700001|NCT00033514|Secondary|Serum Concentration of Herceptin at Specified Time-points.||4 months|||mcg/mL||95% Confidence Interval|Mean
700002|NCT00033514|Secondary|Incidence of Adverse Events||5 years|subjects evaluated for SAEs||participants affected by SAEs|||Number
700003|NCT00033514|Secondary|Duration of Objective Response||5 years|Subjects that achieved objective response (4). All were from phase II.||participants|||Number
700004|NCT00033514|Primary|The Objective Response Rate as Defined as Stable Disease or the Rate of Complete and Partial Responses Determined on Two Consecutive Occasions Greater Than or Equal to 4 Weeks Apart.|"Complete Response:
The disappearance of all signs of cancer in response to treatment. This does not always mean the cancer has been cured. Also called complete remission.
Partial Response:
A decrease in the size of a tumor, or in the extent of cancer in the body, in response to treatment. Also called partial remission."|5 years|12 patients with measurable disease and no prior trastuzumab in the metastatic setting considered evaluable at the recommended phase II dose level. 2 from phase 1 and 10 from phase 2 Excluded : 14 from Phase I: no measureable disease or previous trastuzumab. Phase II: Withdrawn due to disease complications||participants|||Number
700005|NCT00033540|Secondary|Median Survival Time for Participants With Relevant Biologic Markers|To evaluate in a preliminary fashion relevant prognostic markers in gallbladder and cholangiocarcinoma which may have prognostic implications as predictors of survival. Overall survival measured from time of registration to death, or last contact date.|All patients will be followed until death or three years after registration, whichever is first.|Eligible patients who received genotyping were included in this analysis.||months||95% Confidence Interval|Median
700006|NCT00033540|Secondary|Accrual of Patients With This Disease Site|Only eligible patients who received treatment were evaluable for response and survival outcomes.|1-20 months|Patients with advanced disease accrued between September 2003 to April 2005||participants|||Number
700007|NCT00033540|Secondary|Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included. For each patient, worst grade of each event type is reported.|Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment.|Eligible patients who received any treatment and were assessed for toxicity were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.||Participants|||Number
700008|NCT00033540|Secondary|Overall Survival|Measured from time of registration to death, or last contact date|All patients will be followed until death or three years after registration, whichever is first.|All eligible patients who started treatment were included in assessing response estimates.||months||95% Confidence Interval|Median
700009|NCT00033540|Primary|Response|Complete Response (CR) is complete disappearance of all measurable and non-measurable disease. No new lesions, no disease related symptoms. Normalization of markers and other abnormal lab values. Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration. Progression is 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed and/or unequivocal progression of non-measurable disease and/or appearance of new lesion/site or death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration is global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.|Patients assessed at least every six weeks while on protocol treatment|All eligible patients who started treatment were included in assessing response estimates.||participants|||Number
700010|NCT00033631|Secondary|Normal Tissue Complication Probability||From randomization to last follow-up. Analysis can occur any time after the primary endpoint analysis.||06/2018||||
700011|NCT00033631|Secondary|Tumor Control Probability||From randomization to date of failure (tumor progression) or last follow-up. Analysis can occur any time after the primary endpoint analysis.||06/2018||||
700012|NCT00033631|Secondary|Quality Adjusted Survival by SQLI|This analysis will not be done because there was no difference in survival between the two treatment arms.|From randomization to 5 years.||||||
700013|NCT00033631|Secondary|Global Quality of Life (QOL) by Spitzer QOL Index (SQLI)||From randomization to 5 years.||||||
700014|NCT00033631|Secondary|Erectile Function by International Index of Erectile Function (IIEF)||From randomization to 5 years.||||||
700015|NCT00033631|Secondary|Grade 2 or Greater Genitourinary or Gastrointestinal Toxicity|Rate of acute 2+ grade genitourinary(GU)/gastrointestinal(GI) toxicity graded by Common Toxicity Criteria (CTC) version 2.0|From the start of treatment to 90 days. Analysis occurs at the same time as the primary endpoint|Eligible patients with acute adverse event data who did not withdraw consent.||percentage of participants|||Number
700016|NCT00033631|Secondary|Distant Metastases|Failure time is defined as time from randomization to the date of documented regional nodal recurrence or development of distant disease. Failure rates are estimated by the cumulative incidence method. Patients last know to be alive are censored at date of last contact.|From randomization to date of failure (distant metastasis) or death or last follow-up. Analysis occurs at the same time as the primary endpoint.|All eligible patients who have not withdrawn consent||percentage of participants||95% Confidence Interval|Number
700017|NCT00033631|Secondary|Local Progression|Failure time is defined as time from randomization to the date of progression (increase in palpable abnormality), failure of regression of the palpable tumor by two years, and redevelopment of a palpable abnormality after complete disappearance of previous abnormalities. Failure rates are estimated by the cumulative incidence method. Patients last know to be alive are censored at date of last contact.|From randomization to date of failure (local progression) or death or last follow-up. Analysis occurs at the same time as the primary endpoint.|All eligible patients who have not withdrawn consent||percentage of participants||95% Confidence Interval|Number
700018|NCT00033631|Secondary|Disease Specific Survival|Survival time is defined as time from randomization to the date of death due to prostate cancer and is estimated by the cumulative incidence method. Patients last know to be alive are censored at date of last contact. Death due to prostate cancer was defined as primary cause of death certified as due to prostate cancer, or death in association with any of the following conditions: Further clinical tumor progression occurring after initiation of salvage anti-tumor therapy, a rise (that exceeds 1.0 ng/ml) in the serum PSA level on at least two consecutive occasions that occurred during or after salvage androgen suppression therapy, or disease progression in the absence of any anti-tumor therapy.|From randomization to date of failure (death due to prostate cancer) or death from other cause or last follow-up. Analysis occurs at the same time as the primary endpoint.|All eligible patients who did not withdraw consent||percentage of participants||95% Confidence Interval|Number
700019|NCT00033631|Secondary|Prostate-specific Antigen (PSA) Failure by American Society for Therapeutic Radiology and Oncology (ASTRO) Definition|Failure is defined as having 3 consecutive elevations of post-treatment PSA or starting hormones after one or more elevations in post-treatment PSA but before three consecutive elevations were documented. The failure day date was the midpoint between last non-rising PSA and first PSA rise. Failure rates are estimated by the cumulative incidence method. Patients last known to be alive are censored at date of last contact.|From randomization to date of failure (3 consecutive rises) or death or last follow-up. Analysis occurred after patients have been potentially followed for 5 years.|All eligible patients who did not withdraw consent||percentage of participants||95% Confidence Interval|Number
700020|NCT00033631|Primary|Overall Survival|Survival time is defined as time from randomization to the date of death from any cause and is estimated by the Kaplan-Meier Method. Patients last know to be alive are censored at date of last contact.|From randomization to date of failure (death) or last follow-up. Analysis occurs after all patients have been potentially followed for 8 years.|All eligible patients who did not withdraw consent||percentage of participants||95% Confidence Interval|Number
700021|NCT00033657|Secondary|Recurrence-free Survival Time|Recurrence-free survival is measured from the date of complete response to recurrence of the cancer. Patients without recurrence were censored at the last date of known recurrence-free. Median recurrence-free survival time was calculated in the eligible and treated patients.|Approximately 1 month after completing all treatments, then every 3 months up to 2 years, every 6 months from 2-5 years of study entry and annually 6-10 years from study entry|||Months||95% Confidence Interval|Median
700022|NCT00033657|Secondary|Overall Survival Time|Survival was measured from the date of randomization onto study to death from any cause.Patients who were still alive at the end of the study were censored at the last date of known alive. Median survival time was calculated in the 81 eligible and treated patients.|Approximately 1 month after completing all treatments, then every 3 months up to 2 years, every 6 months from 2-5 years of study entry and annually 6-10 years from study entry|Eligible, treated patients||Months||95% Confidence Interval|Median
700023|NCT00033657|Primary|Pathologic Complete Response Rate|A patient would have achieved a pathologic complete response if no histopathological evidence of residual tumor is found in the resected esophageal specimen and nodal tissue.|approximately 1 month after completing all treatments, then every 3 months up to 2 years, every 6 months from 2-5 years of study entry and annually 6-10 years from study entry|Eligible, treated patients||percentage of participants||90% Confidence Interval|Number
700024|NCT00033917|Secondary|Language Outcome|"Peabody Picture Vocabulary Test (PPVT) This is a semantic language test. The mean value is 100; standard deviation is 16 points. A higher score means better language; a lower score means poorer language.
There are no subscales to the PPVT. The measurement unit is points on a scale. A score < 70 indicates severely abnormal language function."|at 8 years|Three hundred twenty eight subjects were available at age 8 years. They were tested with the PPVT.||participants with PPVT score < 70|||Number
700025|NCT00033917|Primary|IVH at 5 Postnatal Days|Cranial ultrasounds were performed daily for the first 5 postnatal days; the main outcome measure was intraaventricular hemorrhage (IVH) at 5 days of age|at 5 days|All subjects had negative cranial ultrasounds with no evidence for IVH at 6 - 12 postnatal hours||IVH|||Number
700026|NCT00025883|Primary|Triglycerides at Baseline, 6 Months, and 12 Months on Treatment With Metreleptin||Baseline, 6 months, 12 months|||mg/dL||Inter-Quartile Range|Geometric Mean
700027|NCT00025883|Primary|Percentage of Glycosylated Hemoglobin at Baseline, 6 Months, and 12 Months on Treatment With Metreleptin|Percentage of glycosylated hemoglobin at Baseline, 6 months, and 12 months on treatment with metreleptin|Baseline, 6 months, 12 months|||percentage of glycated hemoglobin||Standard Deviation|Mean
700028|NCT00026221|Secondary|New Vessel Formation in Patient Tumor Samples|Evaluated using immunohistochemistry.|Up to 2 years|Data were not collected and not assessed.|||||
700029|NCT00026221|Secondary|Comparison of Plasma Levels of VEGF Following Administration of Bevacizumab Alone or in Combination With IFN-alfa|Analyzed by Enzyme-Linked Immunosorbent Assay (ELISA).VEGF only analyzed at baseline.|At baseline|||pg/mL||Full Range|Median
700030|NCT00026221|Primary|Progression-free Survival|Defined as the time from treatment start date until documentation of progressive disease. Evaluated using the new international criteria proposed by the RECIST Committee. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Up to 2 years|||months||Full Range|Median
700032|NCT00026221|Primary|Objective Response Rate|Measured from the time measurement criteria are met for complete response (CR) or partial response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. Evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.|Up to 2 years|||patients|||Number
700033|NCT00026312|Other Pre-specified|Presence of Naturally Occurring Anti-glycan Antibodies|A Fisher’s exact test will be performed to determine if the presence of naturally occurring anti-glycan antibodies correlates with allergic reactions. A Wilcoxon test will be performed to determine if the presence of naturally occurring anti-glycan antibodies correlates with blood levels of dinutuximab.|Up to 10 years||||||
700034|NCT00026312|Other Pre-specified|NKp30 Isoform Expression and SNP|Kaplan-Meier plots of EFS and OS will be generated after dichotomization using the median value for the cohort. To determine the prognostic value of NKp30 isoform expression and SNP, univariate analysis will be performed using a log rank test for EFS and OS. In multivariable analysis of EFS and OS, Cox models will be used to test for the independent prognostic ability of NKp30 isoform expression and SNP, adjusting for significant prognostic factors including v-MYC myelocytomatosis viral related oncogene, neuroblastoma derived (avian) (MYCN) status, INSS stage, histology and age at diagnosis.|1 week before first sargramostim injection (day -1 of course 1)||||||
700035|NCT00026312|Other Pre-specified|Levels of ADCC|Will be descriptively compared.|Up to 10 years||||||
700036|NCT00026312|Other Pre-specified|Isotretinoin Pharmacokinetic Parameters|To determine if there is a relationship of the peak serum concentration level with EFS, the term for this level will be tested in a Cox proportional hazards model. To determine if there is a relationship of the peak serum concentration level with toxicity rates, Kendall’s Tau statistic will be calculated.|At 4 hours after administration on day 14 of course 1||||||
700037|NCT00026312|Other Pre-specified|Genotype of Kir/Kir-ligand|Kaplan-Meier plots of EFS will be generated for the three genotype subgroups of FcR as well as for the three genotype subgroups of Kir/Kir-ligand. In addition, a log rank test comparison will be made in a pairwise fashion of each of the genotypes within FcR and within Kir/Kir-ligand.|Up to 10 years||||||
700038|NCT00026312|Other Pre-specified|Genotype of FcR|Kaplan-Meier plots of EFS will be generated for the three genotype subgroups of FcR as well as for the three genotype subgroups of Kir/Kir-ligand. In addition, a log rank test comparison will be made in a pairwise fashion of each of the genotypes within FcR and within Kir/Kir-ligand.|Up to 10 years||||||
700039|NCT00026312|Other Pre-specified|Circulating B7-H6 Levels|Kaplan-Meier plots of EFS and OS will be generated after dichotomization using the median value for the cohort. To determine the prognostic value of circulating B7-H6 level, univariate analysis will be performed using a log rank test for EFS and OS. In multivariable analysis of EFS and OS, Cox models will be used to test for the independent prognostic ability of circulating B7-H6 level, adjusting for significant prognostic factors including MYCN status, INSS stage, histology and age at diagnosis.|1 week before first sargramostim injection (day -1 of course 1)||||||
700040|NCT00026312|Other Pre-specified|Change in Tumor Biology|A multivariate Cox proportional hazards regression model will test to see if the dinutuximab serum level, HACA titer, effector cell function, or serum marker for effector cell activation are associated with EFS or OS.|Baseline to up to 10 years||||||
700041|NCT00026312|Other Pre-specified|Change in MRD|A descriptive analysis of the change from baseline of MRD will be performed. Also, a Wilcoxon rank-sum test will be performed to compare the median change from baseline of MRD between the two treatment arms. A multivariate Cox proportional hazards regression model will test to see if the change in MRD burden is associated with EFS or OS.|Baseline to up to 10 years||||||
700042|NCT00026312|Other Pre-specified|Cardiac Repolarization|In general, descriptive summaries will include n, mean, standard deviation, median, minimum, maximum and 90% confidence intervals for continuous variables, and n and percent for categorical variables. Summaries will present data by assessment time when appropriate.|Up to 10 years||||||
700043|NCT00026312|Other Pre-specified|Average Level of HACA|The average level of HACA at each collection time point during immunotherapy will be calculated.|Up to 10 years||||||
700044|NCT00026312|Secondary|Overall Survival (OS) of Patients From the Non-randomized Portion of the Trial|OS for patients receiving RA + Immunotherapy following the cessation of the randomized portion of the study.|Three years|Eligible patients non-randomly assigned to Regimen B after halting of randomization, excluding patients with persistent disease||Percentage of participants||95% Confidence Interval|Number
700045|NCT00026312|Secondary|Overall Survival (OS)|Comparison to determine if RA + Immunotherapy improves OS as compared to RA Only. Comparison to determine if RA + Immunotherapy improves OS as compared to RA only and for the subgroup of randomized patients with INSS Stage 4 disease.|Three years|Eligible, randomized patients. Eligible, randomized patients with INSS Stage 4 disease.||Percentage of participants||95% Confidence Interval|Number
700046|NCT00026312|Secondary|Number of Courses of Therapy Delivered|Number of courses of therapy delivered for patients randomized to RA + Immunotherapy vs. patients non-randomly assigned to RA + Immunotherapy, excluding patients with persistent disease.|Courses 1-6|Eligible patients assigned to Regimen B, excluding patients with persistent disease.||courses per patient||Full Range|Median
700047|NCT00026312|Secondary|Incidence of Toxicities Assessed Using Common Terminology Criteria for Adverse Events Version 4.0|Proportion of patients experiencing at least one Grade 3 or higher toxicity.|From enrollment to follow-up|Eligible patients enrolled prior to halting of randomization.||Proportion||95% Confidence Interval|Number
700048|NCT00026312|Secondary|Event-Free Survival (EFS) of Patients From the Non-randomized Portion of the Trial|EFS for patients receiving RA + Immunotherapy following the cessation of the randomized portion of the study.|Three years|Eligible patients non-randomly assigned to Regimen B after halting of randomization, excluding patients with persistent disease.||Percentage of participants||95% Confidence Interval|Number
700157|NCT00031460|Secondary|Number of Participants With Two or Fewer Episodes of Cutaneous Recurrence of Herpes Simplex Virus (HSV) Disease Post-randomization During the Initial 12 Months of Life.|Number of participants experiencing 2 or fewer HSV recurrences during the first 12 months of life as measured by assessments and reports at study visits.|post randomization - 12 months|||participants|||Number
700049|NCT00026312|Secondary|Event-Free Survival (EFS)|Comparison to determine if RA + Immunotherapy improves EFS as compared to RA Only for the subgroup of randomized patients with INSS Stage 4 disease. Descriptive comparison of outcome data for patients with persistent disease documented by biopsy to historical data for the analogous patients from CCG-3981.|Three years|Eligible, randomized patients with INSS Stage 4 disease. Eligible patients with persistent disease.||Percentage of participants||95% Confidence Interval|Number
700050|NCT00026312|Primary|Event-Free Survival (EFS)|Comparison to determine if RA + Immunotherapy improves EFS as compared to RA Only|Three years|Eligible, randomized patients.||Percentage of participants||95% Confidence Interval|Number
700051|NCT00026494|Primary|Radiographic Response Assessed by Macdonald Criteria Every 2 Months|All patients will have their tumor measurements recorded at baseline and at the time of each MRI scan. Lesions must be measured in two dimensions.|2 years|||participants|||Number
700052|NCT00027027|Secondary|Pharmacokinetic Measurement of Terminal Half-Life (t1/2 Terminal) in Days|A one-compartment model was used for the 0.5 mg/kg dose group, and a two-compartment model was used for the 2–15 mg/kg dose groups.|Days 1 (predose, 89 minutes from infusion start, at 1.5, 4, and 8 hours postdose), 2, 5, 8 and 15 of Cycle 1; Days 1 (predose, 29 minutes from infusion start) and 8 of Cycles 2 and beyond until the follow-up visit (4 weeks after the last infusion)|All enrolled participants||days||Standard Deviation|Mean
700053|NCT00027027|Secondary|Pharmacokinetic Measurement of Initial Distribution Half-Life (t1/2 Initial)|A one-compartment model was used for the 0.5 mg/kg dose group, and a two-compartment model was used for the 2–15 mg/kg dose groups.|Days 1 (predose, 89 minutes from infusion start, at 1.5, 4, and 8 hours postdose), 2, 5, 8 and 15 of Cycle 1; Days 1 (predose, 29 minutes from infusion start) and 8 of Cycles 2 and beyond until the follow-up visit (4 weeks after the last infusion)|Only participants in the measured treatment groups where a two-compartment model was used are included in the analysis.||days||Standard Deviation|Mean
700054|NCT00027027|Secondary|Pharmacokinetic Measurement of Steady-State Volume of Distribution (Vss)|A one-compartment model was used for the 0.5 mg/kg dose group, and a two-compartment model was used for the 2–15 mg/kg dose groups.|Days 1 (predose, 89 minutes from infusion start, at 1.5, 4, and 8 hours postdose), 2, 5, 8 and 15 of Cycle 1; Days 1 (predose, 29 minutes from infusion start) and 8 of Cycles 2 and beyond until the follow-up visit (4 weeks after the last infusion)|Only participants in the measured treatment groups where a two-compartment model was used are included in the analysis.||mL/kg||Standard Deviation|Mean
700055|NCT00027027|Secondary|Pharmacokinetic Measurement of Volume of Central Compartment (Vc)|A one-compartment model was used for the 0.5 mg/kg dose group, and a two-compartment model was used for the 2–15 mg/kg dose groups.|Days 1 (predose, 89 minutes from infusion start, at 1.5, 4, and 8 hours postdose), 2, 5, 8 and 15 of Cycle 1; Days 1 (predose, 29 minutes from infusion start) and 8 of Cycles 2 and beyond until the follow-up visit (4 weeks after the last infusion)|All enrolled participants||mL/kg||Standard Deviation|Mean
700056|NCT00027027|Secondary|Pharmacokinetic Measurement of Systemic Clearance (CL)|A one-compartment model was used for the 0.5 mg/kg dose group, and a two-compartment model was used for the 2–15 mg/kg dose groups.|Days 1 (predose, 89 minutes from infusion start, at 1.5, 4, and 8 hours postdose), 2, 5, 8 and 15 of Cycle 1; Days 1 (predose, 29 minutes from infusion start) and 8 of Cycles 2 and beyond until the follow-up visit (4 weeks after the last infusion)|All enrolled participants||mL/day/kg||Standard Deviation|Mean
700057|NCT00027027|Secondary|Pharmacokinetic Measurement of Area Under the Curve (AUC)|Mean rhuMAb 2C4 serum concentrations versus nominal time profiles for the first two treatment cycles are presented for AUC micrograms per milliliters (ug/mL) by day. A one-compartment model was used for the 0.5 mg/kg dose group, and a two-compartment model was used for the 2–15 mg/kg dose groups.|Days 1 (predose, 89 minutes following start of infusion and at 1.5, 4, and 8 hours postdose) 2, 5, 8 and 15 of Cycle 1; Days 1 (predose and 29 minutes following start of infusion) and 8 of Cycle 2|All enrolled participants||ug*hr/mL||Standard Deviation|Mean
700058|NCT00027027|Primary|Number of Participants With Dose-Limiting Toxicities (DLTs)|"Incidence of DLTs defined as any Grade 3 or 4 major organ toxicity according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) Version 2 or any subjectively intolerable toxicity felt by the investigator to be related to rhuMAb 2C4.
One participant in the 15.0 mg/kg dose group experienced a gastrointestinal hemorrhage on Day 16. This event was judged by the investigator to be related to study drug. The participant recovered in 3 days and continued to receive rhuMAb 2C4 beyond Cycle 2.This was the only DLT reported during the first two treatment cycles."|Day 1 of Cycles 1 and 2, and 24 hours after Cycle 2 infusion|All enrolled participants who completed at least 2 cycles of study treatment.||participants|||Number
700059|NCT00027027|Primary|Number of Participants With an Adverse Event (AE), Serious Adverse Event (SAE), or Death|"For this protocol, an AE is defined any untoward medical occurrence (e.g., sign, symptom, disease, syndrome, intercurrent illness, abnormal laboratory finding) that emerges or worsens relative to pretreatment baseline during the treatment or post-treatment periods, regardless of the suspected cause.
For this protocol an SAE was defined as any AE that occurred at any dose if:
It resulted in death (i.e., the AE caused or led to death),
It was life threatening,
It required or prolonged inpatient hospitalization,
It was disabling,
It resulted in a congenital anomaly/birth defect,
It may have jeopardized the participant or may have required medical or surgical intervention to prevent one of the outcomes listed above.
The primary cause of death for all reported cases was disease progression, and all of the deaths occurred following study discontinuation, with one death occurring within 4 weeks of the last treatment day."|Days 1, 2, 5, 8, and 15 of Cycle 1; Days 1, 8, and Week 3, of Cycles 2 and beyond up to 1 year and at the follow-up visit (4 weeks after last infusion)|All enrolled participants||participants|||Number
700060|NCT00035555|Other Pre-specified|Number of Participants Meeting Marked Abnormality Criteria for Select Hemolytic, Blood Chemistry, and Urinalysis Laboratory Test Results|Normal laboratory values: Hemoglobin (g/dL): Males (18-64 years) 13.8-17, (65 years and older) 11.8-16.8; Females (18-64 years) 12.0-15.6, F (65 years and older) 11.1-15.5. Platelets (per mm^3) 130,000-400,000. Leukocytes (18 years and older) 3.8-10.8 1000/uL. ALT (u/L)(13 years and older) 0-48.|Days 8 and Months 1, 3, 6, 9, and 12 posttransplant (from Day 1)|All randomized participants who underwent transplantation and who received treatment||Participants|||Number
700173|NCT00031694|Primary|Response Rate of at Least 30%|Number of participants with a Response rate of at least 30%. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST).|Up to 8 years|||participants|||Number
725225|NCT00351533|Secondary|Hospital Mortality||At end of hospitalization|||Participants|||Number
700061|NCT00035555|Secondary|Number of Participants With Posttransplant Diabetes Mellitus|Posttransplant diabetes mellitus is defined as the need for treatment of hyperglycemia with either an oral agent or insulin for a total of >4 weeks or hemoglobin A1c (HbA1c) >7% in a participant not known to be diabetic prior to transplantation|By Months 1, 3, 6, 9, and 12 posttransplant (Day 1 to Months 1, 3, 6, 9, and 12 )|All randomized participants who received transplants and who were not known to be diabetic prior to transplant||Participants|||Number
700062|NCT00035555|Secondary|Mean LDL Cholesterol, HDL Cholesterol, Total Cholesterol, Triglyceride, and Non-HDL Levels|LDL=low-density lipoprotein; HDL=high-density lipoprotein. Total cholesterol=LDL + HDL + very low-density (VLDL) cholesterol. VLDL=triglycerides divided by 5. Non-HDL cholesterol=Total cholesterol minus HDL cholesterol.|By Months 1, 6, and 12 posttransplant (Day 1 to Months 1, 6, and 12)|All randomized participants who received a transplant; n=evaluable participants.||mg/dL||Standard Deviation|Mean
700063|NCT00035555|Other Pre-specified|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug.|Day 1 (posttransplant) continuously to 56 days following last dose of study medication|All randomized participants who underwent transplantation and who received treatment||Participants|||Number
700064|NCT00035555|Secondary|Number of Participants With Hypertension|Hypertension is defined as diastolic blood pressure ≥90 mm Hg and/or systolic blood pressure ≥140 mm Hg or, the use of any antihypertensive medication.|By Months 6 and 12 posttransplant (Day 1 to Months 6 and 12)|All randomized participants who underwent transplantation||Participants|||Number
700065|NCT00035555|Secondary|Percentage of Participants Who Used Antihypertensive Medication|Hypertension is defined as diastolic blood pressure ≥90 mm Hg and/or systolic blood pressure ≥140 mm Hg|By Months 6 and 12 posttransplant (Day 1 to Months 6 and 12)|All randomized participants who underwent transplantation||Percentage of participants|||Number
700066|NCT00035555|Secondary|Mean Iohexol Clearance|Iohexol, a true glomerular filtration marker, is used to measure glomerular filtration rate.|By Months 1, 6, and 12 posttransplant (Day 1 to Months 1, 6, and 12)|All randomized participants who underwent transplantation||mL/min per 1.73 m^2||Standard Deviation|Mean
700067|NCT00035555|Secondary|Percentage of Participants Who Had Chronic Allograft Nephropathy|Based on postbaseline biopsies|By Months 6 and 12 posttransplant (Day 1 to Months 6 and 12)|All randomized participants who underwent transplantation and who had at least 1 biopsy following Day 1; n=evaluable participants||Percentage of participants|||Number
700068|NCT00035555|Secondary|Percentage of Participants With Acute Rejection or Presumed Acute Rejection (PAR)|Throughout this study, acute rejection=clinically-suspected and biopsy-proven acute rejection (BPAR). Clinically-suspected rejection is defined as an increase in serum creatinine ≥0.5 mg/dL compared with the baseline value in the absence of other factors known to adversely affect renal function. BPAR includes all cases in which a biopsy was read by the central pathologist as demonstrating acute rejection regardless of the reason why the biopsy was performed. PAR is defined as an elevation in SCr ≥0.5 mg/dL compared with the baseline value in the absence of other factors known to adversely affect renal function that led the investigator to suspect that the participant had experienced acute rejection, and in whom either the biopsy did not confirm acute rejection and the participant received treatment for acute rejection or the participant received treatment for acute rejection without a biopsy to confirm the diagnosis.|By Months 6 and 12 posttransplant (Day 1 to Months 6 and 12)|All randomized participants who underwent transplantation||Percentage of participants|||Number
700069|NCT00035555|Secondary|Percentage of Participants With Biopsy-proven Acute Rejection (BPAR) or Who Received Treatment for Acute Rejection|BPAR includes all cases in which a biopsy read by the central pathologist demonstrates acute rejection, regardless of the reason that the biopsy was performed. A participant was reported as having had an episode of treated acute rejection if he or she received antirejection therapy during an episode of rejection (clinically-suspected or biopsy-proven rejection).|By Months 3, 6, and 12 posttransplant (Day 1 to Months 3, 6, and 12)|All randomized participants who underwent transplantation||Percentage of participants|||Number
700070|NCT00035555|Secondary|Percentage of Participants With Biopsy-proven Acute Rejection (BPAR) Through Months 6 and 12|BPAR includes all cases in which a biopsy read by the central pathologist demonstrates acute rejection, regardless of the reason that the biopsy was performed.|Through Months 6 and 12 posttransplant (From Day 1 to Months 6 and 12)|All randomized participants who underwent transplantation||Percentage of participants|||Number
700071|NCT00035555|Primary|Number of Participants With an Episode of Clinically-suspected and Biopsy-proven Acute Rejection (CSPAR)|No participant was to receive treatment for acute rejection without a biopsy to confirm the diagnosis. CSPAR=Clinically-suspected rejection, defined as an increase in serum creatinine ≥0.5 mg/dL compared with the baseline value in the absence of other factors known to adversely affect renal function, and biopsy-proven rejection, which includes all cases in which a biopsy was read by the central pathologist as demonstrating acute rejection regardless of the reason why the biopsy was performed.|By Month 6 posttransplant (From Day 1 to Month 6)|All randomized participants who underwent transplantation||Participants|||Number
700072|NCT00035815|Secondary|Rate of Change in ALS Functional Rating Scale.|The final secondary outcome measure was the rate of change in the ALS Functional Rating Scale (ALSFRS-r) score. The ALSFRS-r was completed at each visit (randomization and then at 3, 6, 12, 18 and 24 months post-randomization). This is a scale from 0 to 48 assessing functional impairment in 12 clinically relevant areas in ALS. Forty-eight is normal with full function and zero is total loss of function in all clinical functions. As with the MMT scores a score of 0 was imputed on the day of death. Analysis of the ALSFRS-r scores as a secondary outcome was performed in similar manner as MMT score.|Baseline and 24 months|||Units on a scale per month||Standard Deviation|Mean
700174|NCT00038103|Secondary|Survival|Time from randomization to date of death (any cause).|Baseline, Weeks 8, 16, 24, every 12 weeks from Week 24 up to Week 108, and every 24 weeks thereafter until 9 months following LSLV or death|Evaluable population||weeks||95% Confidence Interval|Median
725226|NCT00351533|Secondary|Hospital Length of Stay||At end of hospital admission|||Days||Standard Deviation|Mean
700073|NCT00035815|Secondary|Number of Participants Alive and Tracheostomy-free at 24 Months|Patients who elected to proceed to tracheostomy were assessed the month of their procedure. Subjects who continuously utilized non-invasive positive pressure ventilation for greater than 10 days were assessed as being ventilator-dependent on the first day they began continuous Non Invasive Positive Pressure Ventilation (NIPPV). All subjects were followed for the 24 month time period.|baseline to 24 months|||participants|||Number
700074|NCT00035815|Primary|Rate of Change in Composite Manual Muscle Testing (MMT) Score|The primary outcome measure was the rate of change in the MMT score. MMT involved the examination of 34 muscle groups with standard positioning. The final MMT score represented an average of the 34 muscles examined, and ranged from 10 to 0(10 normal strength, 0 paralyzed). The individual muscle score was based on the medical research council (MRC) grading scale (1-5) modified to a 10 point system corresponding to the MRC modifications of plus and minus (5, 5-,4+,4,4-,3+,3, 3-,2,1,0; with 5 being normal strength and 0 paralyzed).|Baseline and 24 months|||MMT units per month||Standard Deviation|Mean
700075|NCT00035932|Secondary|HIV RNA Level - Treated Subjects With Evaluable Cmins at Week 48|Week 24 HIV RNA level and change from baseline were summarized for treated subjects with evaluable Cmins.|Baseline, Week 48|Formal population PK/PD analysis was not performed due to difficulties in correlating time of blood sample collection with drug administration, and inability to apply the PK model generated with data obtained from healthy subjects due to newly observed differences in exposure to atazanavir between HIV-infected participants and healthy participants.||log10 c/mL||Standard Error|Mean
700076|NCT00035932|Secondary|HIV RNA Level - Treated Subjects With Evaluable Cmins at Week 24|Week 24 HIV RNA level and change from baseline were summarized for treated subjects with evaluable Cmins.|Baseline, Week 24|Participants with evaluable Cmins; as-randomized population (refers to the treatment regimen assigned at randomization).||log10 c/mL||Standard Error|Mean
700077|NCT00035932|Secondary|Inhibitory Quotient at Week 48|Inhibitory quotient is a measure of drug exposure and susceptibility in an individual. The IQ is typically calculated as the ratio of Cmin to HIV IC50.|Baseline, Week 48|Formal population PK/PD analysis was not performed due to difficulties in correlating time of blood sample collection with drug administration, and inability to apply the PK model generated with data obtained from healthy subjects due to newly observed differences in exposure to atazanavir between HIV-infected participants and healthy participants.||ratio||Standard Error|Mean
700078|NCT00035932|Secondary|Inhibitory Quotient at Week 24|Inhibitory quotient is a measure of drug exposure and susceptibility in an individual. The IQ is typically calculated as the ratio of Cmin to HIV IC50.|Baseline, Week 24|Participants with evaluable IQ measurements (ie, must have both Cmin and IC50 measurements); as-randomized population (refers to the treatment regimen assigned at randomization).||ratio||Standard Error|Mean
700079|NCT00035932|Secondary|HIV IC50 at Week 24|IC50: inhibitory concentration of drug required to reduce viral replication by 50%.|Week 24|Participants with evaluable IC50 measurements; as-randomized population (refers to the treatment regimen assigned at randomization).||ng/mL||Standard Error|Mean
700080|NCT00035932|Secondary|Mean ATV, RTV and SQV Minimum Concentration (Cmin) Values|"The minimum or trough concentration (Cmin) of a drug observed after its administration and just prior to the administration of a subsequent dose."|collected at the pre-dose time point after receiving atazanavir for at least four weeks|Participants with evaluable Cmins; as-randomized population (refers to the treatment regimen assigned at randomization).||ng/mL||Standard Error|Mean
700081|NCT00035932|Secondary|Number of Participants Utilizing Resources for Managing Lipid Elevation|Participants' overall resource utilization for managing lipid elevation that includes the management of side effects of lipid lowering medications, such as those due to drug interactions.|Baseline, Week 24, Week 48|Although the intent of this planned analysis was to provide a model of economic value for Lipid Management, a different approach was taken to create this model which did not require data from this trial, and thus this analysis was not done.||Participants|||Number
700082|NCT00035932|Primary|Mean Change From Baseline in HIV RNA at Week 96||Baseline, Week 96|Randomized participants while on initial regimen||log10 c/mL||Standard Error|Mean
700083|NCT00035932|Secondary|Mean Score of European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Baseline, Mid-Study (Week 24), and Final (Week 48)|The EQ-5D has a Visual Analog Scale (VAS), which is a feeling thermometer-like scale with a range between 0 and 100. Patients are required to draw a line from a box on the VAS scale to an actual mark on the thermometer-like scale that corresponds with a number that reflects their self-assessed health status at the time they are completing the questionnaire. Higher VAS scores indicate better overall health. There is no minimum clinically important difference reported in the literature for VAS.|Baseline, Week 24, Week 48|Treated participants; as-randomized population (refers to the treatment regimen assigned at randomization). n=number of participants evaluated with EQ-5D at given time point.||units on a scale||Standard Error|Mean
700084|NCT00035932|Secondary|Mean Score of European Quality of Life-5 Dimensions (EQ-5D) Health Index Score at Baseline, Mid-Study (Week 24), and Final (Week 48)|The EQ-5D is a 5-item questionnaire to assess health-related quality of life in 5 health dimensions (mobility, self-care, usual activity, pain/discomfort, anxiety/depression) are scored on a 3-level scale: no problems (1), some problems (2), extreme problems (3). Using a standard algorithm, responses are summarized into a single score, the EQ-5D Health Index Score (HIS), which ranges between 1 (representing perfect health) and 0 (representing the worst imaginable health state or death). The smallest coefficient of change is 0.03.|Baseline, Week 24, Week 48|Treated participants; as-randomized population (refers to the treatment regimen assigned at randomization). n=number of participants evaluated with EQ-5D at given time point.||units on a scale||Standard Error|Mean
700085|NCT00035932|Secondary|Adherence to Regimen Though Week 48 Based on MACS the Multicenter AIDS Cohort Study (MACS) Adherence Questionnaire|The MACS adherence questionnaire asks patients how many medication doses they missed during the previous day, 2 days, 3 days and 4 days. Drug-specific questions included adherence with dose and frequency. Adherence was defined as taking all doses and numbers of pills as prescribed for each medication. This strict adherence cut-off was based on the guidelines stating that anything less than excellent adherence may result in a virus breakthrough and development of resistance.|Baseline, Week 24, Week 48|Number of Participants Analyzed=treated participants; as-randomized population (refers to the treatment regimen assigned at randomization); n=subset of treated participants (Given the language limitation, a subset of the AI424045 population was included in the MACS adherence analysis.)||participants|||Number
700086|NCT00035932|Secondary|PR Interval and Change From Baseline by Analysis Time Point|The PR interval is measured from the beginning of the P wave to the beginning of the QRS complex, and reflects the time the electrical impulse takes to travel from the sinus node through the atrioventricular (AV) node and entering the ventricles. The PR interval is therefore a good estimate of AV node function.|Baseline, Week 4 predose, 2-3 hours postdose, 6-12 hours postdose, Week 12, Week 24, Week 48|Treated participants; as-randomized population (refers to the treatment regimen assigned at randomization). n=number of participants evaluated at timepoint||msec||Standard Error|Mean
700087|NCT00035932|Secondary|Fridericia-corrected QT (QTcF) Interval and Change From Baseline by Analysis Time Point|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. The QT interval was corrected for heart rate using Fridericia's (QTcF) formula.|Baseline, Week 4 predose, 2-3 hours postdose, 6-12 hours postdose, Week 12, Week 24, Week 48|Treated participants; as-randomized population (refers to the treatment regimen assigned at randomization). n=number of participants evaluated at timepoint||msec||Standard Error|Mean
700088|NCT00035932|Secondary|Grade 3/4 Laboratory Abnormalities Through Week 48|Common Terminology Criteria for Adverse Events v3.0 (CTCAE) Grades:1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death. Abnormal values: absolute neutrophil count: ≥500 to <750/mm3 (grade 3), <500/mm3 (grade 4); platelets: 20,000-49,999/mm3 (grade 3), <20,000/mm3 or diffuse petechiae (grade 4); alanine transaminase (ALT): 5.1-10 x upper limit of normal (ULN; grade 3), >10 x ULN (grade 4); aspartate transaminase (AST): 5.1-10 x ULN (grade 3), >10 x ULN (grade 4); bilirubin: 2.6-5 x ULN (grade 3), >5 x ULN (grade 4).|From Enrollment to Week 48|Evaluable treated participants; as-randomized population (refers to the treatment regimen assigned at randomization).||participants|||Number
700089|NCT00035932|Secondary|Fasting Glucose Mean Change From Baseline at Week 48||Week 48|Treated Participants with evaluation at time point; as-randomized population (refers to the treatment regimen assigned at randomization).||mg/dL||Standard Error|Mean
700090|NCT00035932|Secondary|Fasting Glucose Mean Change From Baseline at Week 24||Baseline, Week 24|Treated Participants with evaluation at time point; as-randomized population (refers to the treatment regimen assigned at randomization).||mg/dL||Standard Error|Mean
700091|NCT00035932|Secondary|Most Common AEs and AEs of Interest Through Week 48|Prespecified AEs of interest included jaundice, ocular icterus, and hyperbilirubinemia.|From Enrollment to Week 48|Treated participants; as-randomized population (refers to the treatment regimen assigned at randomization).||participants|||Number
700092|NCT00035932|Secondary|Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) Through Week 48|AE=any new untoward medical occurrence/worsening of a pre-existing medical condition regardless of causal relationship. SAE=any untoward medical occurrence at any dose that: results in death; is life-threatening; requires/prolongs inpatient hospitalization; results in persistent/significant disability; is cancer; is congenital anomaly/birth defect; results in drug dependency/abuse; is an important medical event.|From Enrollment through Week 48|Randomized participants for Deaths and SAEs; treated participants for all others; as-randomized population (refers to the treatment regimen assigned at randomization). In addition, of the 213 screen failures (not randomized), there were 4 subjects who had an SAE; these are not included in the table below.||participants|||Number
700093|NCT00035932|Secondary|Lipid Mean Percent Change From Baseline at Week 96, Observed Values|Mean percent change in total cholesterol, high density lipoprotein (HDL) cholesterol, fasting low density lipoprotein (LDL) cholesterol, and fasting triglycerides.|Week 96|Treated Participants; as-randomized population (refers to the treatment regimen assigned at randomization).||percent change in lipid values|||Number
700094|NCT00035932|Secondary|Lipid Mean Percent Change From Baseline at Week 48|Mean percent change in total cholesterol, high density lipoprotein (HDL) cholesterol, fasting low density lipoprotein (LDL) cholesterol, and fasting triglycerides.|Week 48|Treated Participants, Last Observation Carried Forward (LOCF); as-randomized population (refers to the treatment regimen assigned at randomization).||percent change in lipid values|||Number
700095|NCT00035932|Secondary|Lipid Mean Percent Change From Baseline at Week 24|Mean percent change in total cholesterol, high density lipoprotein (HDL) cholesterol, fasting low density lipoprotein (LDL) cholesterol, and fasting triglycerides.|Baseline, Week 24|Treated Participants, Last Observation Carried Forward (LOCF), as-randomized population (refers to the treatment regimen assigned at randomization).||percent change|||Number
700096|NCT00035932|Secondary|Correlation of ATV Minimum Plasma Concentration (Cmin) Inhibitory Quotient (IQ), and Number of PI Mutations at Baseline and CD4 Cell Count Change From Baseline at Week 48|Pearson correlations of the Cmin (trough plasma concentration), IQ (the ratio of Cmin of ATV to HIV IC50), and Number of baseline PI Mutations with CD4 cell count change from baseline at Week 48 were explored.|Baseline, Week 48|Formal population PK/PD analysis was not performed due to difficulties in correlating time of blood sample collection with drug administration, and inability to apply the PK model generated with data obtained from healthy subjects due to newly observed differences in exposure to atazanavir between HIV-infected participants and healthy participants.||Pearson Correlation Coefficient|||Number
700097|NCT00035932|Secondary|Correlation of ATV Minimum Plasma Concentration (Cmin) Inhibitory Quotient (IQ), and Number of PI Mutations at Baseline and CD4 Cell Count Change From Baseline at Week 24|Pearson correlations of the Cmin (trough plasma concentration), IQ (the ratio of Cmin of ATV to HIV IC50), and Number of baseline PI Mutations with CD4 cell count change from baseline at Week 24 were explored.|Baseline, Week 24|Participants with evaluable PK measurements, as-randomized population (refers to the treatment regimen assigned at randomization).||Pearson Correlation Coefficient|||Number
700098|NCT00035932|Secondary|Correlation of ATV Minimum Plasma Concentration (Cmin), Inhibitory Quotient (IQ), and Number of Protease Inhibitor (PI) Mutations at Baseline With HIV RNA Change From Baseline at Week 48|Pearson correlations of the Cmin (trough plasma concentration), IQ (the ratio of Cmin of ATV to HIV IC50), and Number of baseline PI Mutations with HIV RNA change from baseline at Week 48 were explored.|Baseline, Week 48|Formal population PK/PD analysis was not performed due to difficulties in correlating time of blood sample collection with drug administration, and inability to apply the PK model generated with data obtained from healthy subjects due to newly observed differences in exposure to atazanavir between HIV-infected participants and healthy participants.||Pearson Correlation Coefficient|||Number
701582|NCT00054717|Secondary|Virologic Response (VL < 400 Copies/ml) at Week 48|Percentage of participants with Viral Load < 400 copies/mL|Week 48|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
700099|NCT00035932|Secondary|Correlation of ATV Minimum Plasma Concentration (Cmin), Inhibitory Quotient (IQ), and Number of Protease Inhibitor (PI) Mutations at Baseline With HIV RNA Change From Baseline at Week 24|Pearson correlations of the Cmin (trough plasma concentration), IQ (the ratio of Cmin of ATV to HIV IC50), and Number of baseline PI Mutations with HIV RNA change from baseline at Week 24 were explored.|Baseline, Week 24|Week 24: Participants with evaluable PK measurements||Pearson Correlation Coefficient|||Number
700100|NCT00035932|Secondary|Change From Baseline in CD4 Cell Count at Week 96||Baseline, Week 96|Randomized participants (while on initial regimen) with evaluation at time point||cells/mm3||Standard Error|Mean
700101|NCT00035932|Secondary|Change From Baseline in CD4 Cell Count at Week 48||Baseline, Week 48|Randomized participants while on initial regimen (completers censored).||cells/mm3||Standard Error|Mean
700102|NCT00035932|Secondary|Change From Baseline in CD4 Cell Count at Week 24||Baseline, Week 24|Randomized participantsRandomized participants while on initial regimen (completers censored).||cells/mm3||Standard Error|Mean
700103|NCT00035932|Secondary|Participants Achieving Treatment Response (LOQ = 50 c/mL) Without Prior Failure at Week 96|Treatment Response = confirmed suppression to LOQ (50 c/mL). The Algorithm for Treatment Response Without Prior Failure (TRPWF) = participants staying in response at the analysis timepoint without having an intervening, confirmed rebound.|Week 96|Randomized participants while on initial regimen (completers censored)||participants|||Number
700104|NCT00035932|Secondary|Participants Achieving Treatment Response (LOQ = 50 c/mL) Without Prior Failure at Week 48|Treatment Response = confirmed suppression to LOQ (50 c/mL). The Algorithm for Treatment Response Without Prior Failure (TRPWF) = participants staying in response at the analysis timepoint without having an intervening, confirmed rebound.|Week 48|Randomized participantsRandomized participants while on initial regimen (completers censored).||participants|||Number
700105|NCT00035932|Secondary|Participants Achieving Treatment Response (LOQ = 50 c/mL) Without Prior Failure at Week 24|Treatment Response = confirmed suppression to LOQ (50 c/mL). The Algorithm for Treatment Response Without Prior Failure (TRPWF) = participants staying in response at the analysis timepoint without having an intervening, confirmed rebound.|Week 24|Randomized participants, as-randomized population (refers to the treatment regimen assigned at randomization).||participants|||Number
700106|NCT00035932|Secondary|Participants Achieving Treatment Response (LOQ = 400 c/mL) Without Prior Failure at Week 96|Treatment Response = confirmed suppression to LOQ (400 c/mL). The Algorithm for Treatment Response Without Prior Failure (TRPWF) = participants staying in response at the analysis timepoint without having an intervening, confirmed rebound.|Week 96|Randomized participants while on initial regimen (completers censored).||participants|||Number
700107|NCT00035932|Secondary|Participants Achieving Treatment Response (LOQ = 400 c/mL) Without Prior Failure at Week 48|Treatment Response = confirmed suppression to LOQ (400 c/mL). The Algorithm for Treatment Response Without Prior Failure (TRPWF) = participants staying in response at the analysis timepoint without having an intervening, confirmed rebound.|Week 48|Randomized participants, as-randomized population (refers to the treatment regimen assigned at randomization).||participants|||Number
700108|NCT00035932|Secondary|Participants Achieving Treatment Response (LOQ = 400 c/mL) Without Prior Failure at Week 24|Treatment Response = confirmed suppression to LOQ (400 c/mL). The Algorithm for Treatment Response Without Prior Failure (TRPWF) = participants staying in response at the analysis timepoint without having an intervening, confirmed rebound.|Week 24|Randomized participants while on initial regimen Randomized participants, (completers censored).||participants|||Number
700109|NCT00035932|Secondary|Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 96||Week 96|Randomized participants while on initial regimen (completers censored).||Participants|||Number
700110|NCT00035932|Secondary|Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 48, by PI Sensitivity|Number of participants with a >=0.5 log10 decrease in HIV RNA from baseline or HIV RNA < 50 c/mL at Week 48, by their baseline phenotypic sensitivity to their randomized PI.|Baseline, Week 48|As there were multiple efficacy algorithms run and multiple subsets analyzed, it was decided to only use LOQ < 50 on the primary endpoint, and to run LOQ<400 for subsets such as baseline PI sensitivity.||participants|||Number
700111|NCT00035932|Secondary|Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 48||Week 48|Randomized participants; as-randomized population (refers to the treatment regimen assigned at randomization).||Participants|||Number
700112|NCT00035932|Secondary|Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 24, by PI Sensitivity|Number of participants with a >=0.5 log10 decrease in HIV RNA from baseline or HIV RNA < 50 c/mL at Week 24, by their baseline phenotypic sensitivity to their randomized PI.|Baseline, Week 24|As there were multiple efficacy algorithms run and multiple subsets analyzed, it was decided to only use LOQ < 50 on the primary endpoint, and to run LOQ<400 for subsets such as baseline PI sensitivity.||participants|||Number
700113|NCT00035932|Secondary|Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 24||Week 24|Randomized participants; as-randomized population (refers to the treatment regimen assigned at randomization).||participants|||Number
700114|NCT00035932|Secondary|Participants Achieving Virologic Half Log Suppression (LOQ = 400 c/mL) at Week 96|Number of participants with a >=0.5 log10 decrease in HIV RNA from baseline or HIV RNA < 400 c/mL at Week 96.|Baseline, Week 96|Observed case analysis: Randomized participants (while on initial regimen--completers censored) with baseline and on-study measurement.||participants|||Number
700115|NCT00035932|Primary|Mean Change From Baseline in HIV RNA at Week 48||Baseline, Week 48|Randomized participants; as-randomized population (refers to the treatment regimen assigned at randomization).||log10 c/mL||Standard Error|Mean
700116|NCT00035932|Secondary|Participants Achieving Virologic Half Log Suppression (LOQ = 400 c/mL) at Week 48, (Overall and by PI Sensitivity)|Number of participants with a >=0.5 log10 decrease in HIV RNA from baseline or HIV RNA < 400 c/mL at Week 48, by their baseline phenotypic sensitivity to their randomized PI.|Baseline, Week 48|Number of Participants Analyzed=Randomized participants; as-randomized population (refers to the treatment regimen assigned at randomization).n=number of evaluable (overall, PI sensitive, PI resistant) participants.||participants|||Number
700823|NCT00051636|Secondary|Relative Change in Serum Alkaline Phosphatase (SAP) in Units Per Liter (U/L) at Day 28|The percent change in serum alkaline phosphatase from baseline to day 28 was measured.|Baseline and day 28|Intent-to-treat population: all randomized patients. Participants with observations at baseline and 28 days were included in this analysis.||percent change||Standard Deviation|Mean
700117|NCT00035932|Secondary|Participants Achieving Virologic Half Log Suppression (Limit of Quantification [LOQ] = 400 c/mL) at Week 24 (Overall and by Protease Inhibitor [PI] Sensitivity)|Number of participants with a >=0.5 log10 decrease in HIV RNA from baseline or HIV RNA < 400 c/mL at Week 24, by their baseline phenotypic sensitivity to their randomized PI.|Baseline, Week 24|Number of Participants Analyzed=Randomized participants; as-randomized population (refers to the treatment regimen assigned at randomization); n=number of evaluable (overall, PI sensitive, PI resistant) participants.||participants|||Number
700118|NCT00035932|Secondary|Mean Change From Baseline in HIV RNA at Week 2||Baseline, Week 2|Treated participants, as-randomized (refers to the treatment regimen assigned at randomization).||log10 c/mL||Standard Error|Mean
700119|NCT00035932|Primary|Mean Change From Baseline in HIV Ribonucleic Acid (RNA) at Week 24||Baseline, Week 24|Randomized participants; as-randomized population (refers to the treatment regimen assigned at randomization).||log10 c/mL||Standard Error|Mean
700120|NCT00036270|Secondary|Number of Participants With New Primary Non-breast Cancers|Number of participants with new primary non-breast cancers which included colorectal cancer, lung cancer, endometrial cancer, ductal carcinoma in situ (DCIS) and other primary cancer types.|Baseline (Month 0) up to 5 years|ITT population: participants randomized to one of the two study arms (all randomized participants); (n) = number of participants at observation for exemestane and tamoxifen, respectively. All participants were censored at the data cut off date of 08 November 2009.||Participants|||Number
700121|NCT00036270|Secondary|Number of Events for Time to Relapse|Number of events to time of observation for relapse. Relapse is defined as all recurrences of the primary tumor (loco-regional and distant recurrence), second primary breast cancer, contralateral breast cancer.|Baseline (Month 0) up to 5 years|ITT population: participants randomized to one of the two study arms (all randomized participants); (n) = number of participants at observation for exemestane and tamoxifen, respectively. All participants were censored at the data cut off date of 08 November 2009.||Events (disease relapse)|||Number
700122|NCT00036270|Secondary|Time to New Primary Breast Cancers|New primary breast cancers were defined as events of ipsilateral/contralateral breast cancer (CBC).|Baseline (Month 0) up to 5 years|Data was not analyzed due to insufficient number of events reported for the endpoint.|||||
700123|NCT00036270|Secondary|Number of Events for Overall Survival (OS)|Number of events (death) to time of observation for OS. OS is the duration from randomization to death. For participants who are alive, overall survival is censored at the last contact.|Baseline (Month 0) up to 5 years|ITT population: participants randomized to one of the two study arms (all randomized participants); (n) = number of participants at observation for exemestane and tamoxifen, respectively. All participants were censored at the data cut off date of 08 November 2009.||Events (death)|||Number
700124|NCT00036270|Primary|Disease Free Survival (DFS): Number of Events (Disease Relapse or Death) From Baseline up to 5 Years|Number of events (disease relapse or death) to time of observation for DFS. DFS defined as time from randomization to earliest documentation of disease relapse or death from any cause in postmenopausal, receptor positive, node negative or node positive breast cancer patients for adjuvant treatment with exemestane compared with adjuvant tamoxifen therapy at 5 years. Disease relapse: primary tumor recurrence (locoregional or distant) and ipsilateral or contralateral breast cancer (CBC). Intercurrent death: death without disease relapse.|Baseline (Month 0) up to 5 years|ITT population included all participants who were randomized to one of the two study arms (all randomized participants); (n) = number of participants at observation for exemestane and tamoxifen, respectively. All participants were censored at the data cut off date of 08 November 2009.||Events (disease relapse or death)|||Number
700125|NCT00036270|Primary|Disease Free Survival (DFS): Number of Events (Disease Relapse or Death) From Baseline up to 2.75 Years|Number of events (disease relapse or death) to time of observation for DFS. DFS defined as time from randomization to earliest documentation of disease relapse or death from any cause in postmenopausal, receptor positive, node negative or node positive breast cancer patients for adjuvant treatment with exemestane compared with adjuvant tamoxifen therapy at 2.75 years. Disease relapse: primary tumor recurrence (locoregional or distant) and ipsilateral or contralateral breast cancer (CBC). Intercurrent death: death without disease relapse.|Baseline (Month 0) up to 2.75 years|Intent-to-Treat (ITT) population: participants randomized to one of the two study arms (all randomized participants); (n) = number of participants at observation for exemestane and tamoxifen, respectively. All participants were censored at 2.75 years.||Events (disease relapse or death)|||Number
700126|NCT00036569|Secondary|Number of Participants With a Metabolic and Biological Change in the Brainstem Through Magnetic Resonance Imaging (MRI) Techniques|MRI of the brain will be performed at the NCI prior to cycles 1, 2, 3, 5, 7, and continuing every other month until cycle 27. Following cycle 27 the patient will have an MRI performed every third cycle until cycle 52 at which time they will have an MRI performed annually, and when clinically indicated. Baseline MR images are compared with MR images performed during the various cycles (e.g. cycles 1, 2, 3...) Imaging was exploratory and the degree of change that is considered clinically significant rather than technique related is still being explored.|once a week for 4 weeks beginning 2-10 weeks after completion of radiation therapy and continued until disease progression or one of the other off study criteria.|||Participants|||Number
700127|NCT00036569|Secondary|Mean Quality of Life (QOL) Score at Baseline and Follow-Up|QOL questionnaires will be performed prior to every cycle for patients age 6-18 years and their parents until cycle 27 and then prior to every third cycle until cycle 52 when the evaluations will become annual. The QOL (NIH Impact of Pediatric Illness Scale) is too detailed to be described and/or shown here. It is a questionnaire made up of approximately 40 questions-the answers are ranked from 1 to 5 with 5 being no impact and 1 being significant impact-For further details see the protocol.|once a week for 4 weeks beginning 2-10 weeks after completion of radiation therapy and continued until disease progression or one of the other off study criteria.|||Units on a scale||Standard Error|Mean
700128|NCT00036569|Secondary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|8 yrs 11 mo 22 days|||Participants|||Number
700129|NCT00036569|Secondary|Median Time to Progression|Time between the final day of treatment to the day of disease progression.|8 yrs 11 mo 22 days|||Days|||Number
700130|NCT00036569|Primary|Two Year Survival of Pediatric Patients With Diffuse Pontine Gliomas|Survival is measured from the date the patient is registered onto the protocol until the day of death and the date of diagnosis to the date of patient death.|8 yrs 6 mo 0 days|||Percentage of patients|||Number
700136|NCT00037830|Secondary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) Motor Score From Baseline to Week 96 Assessed Off Medication.|The Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) motor scores assess 14 symptoms some of which separately assess symptoms in different body parts (e.g. right arm, left arm, right leg, left leg) and each symptom is rated on a scale from 0 (normal) to 4 (severe). The minimum total score possible is 0 and the maximum total score possible is 108. Each subject was independently rated by two observers at each study visit and a mean score was calculated for analysis.|Baseline to Week 96|Number of subjects enrolled at this time point.||Scores on scale||Standard Error|Mean
700137|NCT00037830|Secondary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) Motor Score From Baseline to Week 72 Assessed Off Medication.|The Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) motor scores assess 14 symptoms some of which separately assess symptoms in different body parts (e.g. right arm, left arm, right leg, left leg) and each symptom is rated on a scale from 0 (normal) to 4 (severe). The minimum total score possible is 0 and the maximum total score possible is 108. Each subject was independently rated by two observers at each study visit and a mean score was calculated for analysis.|Baseline to Week 72|Number of subjects enrolled at this time point.||Scores on a scale||Standard Error|Mean
700138|NCT00037830|Secondary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) Motor Score From Baseline to Week 48 Assessed Off Medication.|The Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) motor scores assess 14 symptoms some of which separately assess symptoms in different body parts (e.g. right arm, left arm, right leg, left leg) and each symptom is rated on a scale from 0 (normal) to 4 (severe). The minimum total score possible is 0 and the maximum total score possible is 108. Each subject was independently rated by two observers at each study visit and a mean score was calculated for analysis.|Baseline to Week 48|||Scores on a scale||Standard Error|Mean
700139|NCT00037830|Secondary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) Motor Score From Baseline to Week 24 Assessed Off Medication.|The Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) motor scores assess 14 symptoms some of which separately assess symptoms in different body parts (e.g. right arm, left arm, right leg, left leg) and each symptom is rated on a scale from 0 (normal) to 4 (severe). The minimum total score possible is 0 and the maximum total score possible is 108. Each subject was independently rated by two observers at each study visit and a mean score was calculated for analysis.|Baseline to Week 24|||Scores on a scale||Standard Error|Mean
700140|NCT00037830|Secondary|Change in Total UPDRS Score From Baseline to Week 120 Assessed Off Medication|The total Unified Parkinson's Disease Rating Scale (UPDRS) score is derived from Part I (Mentation, Behavior and Mood), Part II (Activities of Daily Living) and Part III (Motor Examination). Part I assesses 4 functions; Part II assesses 13 activities of daily living; Part III assesses 14 motor symptoms. Each item is rated on a scale from 0 (normal) to 4 (severe). The minimum total score possible is 0 and the maximum total score possible is 176. Each subject was independently rated by two observers at each study visit and a mean score was calculated for analysis.|Baseline to Week 120|Analysis was per protocol. Two subjects randomized to the Early-Start group withdrew from the study shortly after starting. The comparison group was not compared statistically to the treatment group since they were not randomized.||Scores on a scale||Standard Error|Least Squares Mean
700141|NCT00037830|Secondary|Change From Baseline to Week 24 in Total Unified Parkinson's Disease Rating Scale (UPDRS)Score Assessed Off Medication|The total Unified Parkinson's Disease Rating Scale (UPDRS) score is derived from Part I (Mentation, Behavior and Mood), Part II (Activities of Daily Living) and Part III (Motor Examination). Part I assesses 4 functions; Part II assesses 13 activities of daily living; Part III assesses 14 motor symptoms. Each item is rated on a scale from 0 (normal) to 4 (severe). The minimum total score possible is 0 and the maximum total score possible is 176. Each subject was independently rated by two observers at each study visit and a mean score was calculated for analysis.|Baseline to Week 24|Analysis was per protocol. Two subjects randomized to the Early-Start group withdrew from the study shortly after starting. The comparison group was not compared statistically to the treatment group since they were not randomized.||Scores on a scale||Standard Error|Least Squares Mean
700142|NCT00037830|Post-Hoc|Estimated Rate of Change in Unified Parkinson's Disease Rating Scale (UPDRS)Motor Scores Assessed Off Medication||Week 36 to Week 120|Analysis was per protocol. Two subjects randomized to the Early-Start group withdrew from the study shortly after starting. The comparison group was not compared statistically to the treatment group since they were not randomized.||Scores on a scale||Standard Error|Mean
700143|NCT00037830|Post-Hoc|Estimated Change in Points Per Week on Unified Parkinson's Disease Rating Scale (UPDRS) Motor Score Assessed Off Medication|Unified Parkinson's Disease Rating Scale (UPDRS) A four part scale used to assess the severity of Parkinson's disease symptoms. Part I contains questions concerning the patient's mentation, behavior and mood. Part II asks questions about the patient's ability to perform activities of daily living. Part III is the motor examination of the patient's symptoms ranging in scores from 0 to 4 with 0 equaling either normal or absence of symptoms. The minimum score on this section is 0 and the maximum is 108. Part IV asks the patient questions about any complications of therapy they have experienced within the past week. However, for this study the total UPDRS included Parts I, II, and III. A higher the score on the scale indicates more severe symptoms.|Week 6 to Week 24|Analysis was per protocol. Two subjects randomized to the Early-Start group withdrew from the study shortly after starting. The comparison group was not compared statistically to the treatment group since they were not randomized.||Scores on a scale||Standard Error|Mean
700144|NCT00037830|Primary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) Motor Scores From Baseline to Week 120 Assessed Off Medication.|The Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) motor scores assess 14 symptoms some of which separately assess symptoms in different body parts (e.g. right arm, left arm, right leg, left leg) and each symptom is rated on a scale from 0 (normal) to 4 (severe). The minimum total score possible is 0 and the maximum total score possible is 108. Each subject was independently rated by two observers at each study visit and a mean score was calculated for analysis.|Baseline to Week 120|Analysis was per protocol. Two subjects randomized to the Early-Start group withdrew from the study shortly after starting. The comparison group was not compared statistically to the treatment group since they were not randomized.||Scores on a scale||Standard Error|Least Squares Mean
701583|NCT00054717|Secondary|Virologic Response (VL < 400 Copies/ml) at Week 40|Percentage of participants with Viral Load < 400 copies/mL|Week 40|||Percentage of participants|||Number
700145|NCT00037830|Primary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) Motor Score From Baseline to Week 24 Assessed Off Medication.|The Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) motor scores assess 14 symptoms some of which separately assess symptoms in different body parts (e.g. right arm, left arm, right leg, left leg) and each symptom is rated on a scale from 0 (normal) to 4 (severe). The minimum total score possible is 0 and the maximum total score possible is 108. Each subject was independently rated by two observers at each study visit and a mean score was calculated for analysis.|Baseline to Week 24|Analysis was per protocol. Two subjects randomized to the Early-Start group withdrew from the study shortly after starting. The comparison group was not compared statistically to the treatment group since they were not randomized.||Scores on a scale||Standard Error|Least Squares Mean
700146|NCT00030823|Primary|Safety|By assessing the toxicity and will be graded following immunization with polyvalent vaccine in accordance with the NCI Common Toxicity Criteria 2.0.|2 years|All 13 participants experienced toxicities.||participants|||Number
700147|NCT00030901|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 2.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|3 months after randomization and then every 3 months for 3 years|Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.||Participants|||Number
700148|NCT00030901|Primary|Presence of Carcinoma of the Prostate as Measured by Biopsy|The primary endpoint is biopsy-proven presence/absence of carcinoma of the prostate within 3 years after randomization to treatment. An end-of-study biopsy at 3 years after randomization will be used to determine presence/absence of prostate carcinoma in those patients not previously diagnosed with prostate carcinoma on study. Biopsies performed within ± 90 days of the 3-year anniversary will be considered end-of-study biopsies. Pathologically confirmed presence of prostate carcinoma may be determined at any time during the 3 years and 90 days after randomization, but absence can only be determined by the end-of-study biopsy.|3 years|All eligible randomized patients who started treatment and have prostate cancer known through an interim biopsy or a biopsy taken at +/- 90 days of the end of study were included in the analysis.||participants|||Number
700149|NCT00030992|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|10 years|||Participants|||Number
700150|NCT00030992|Primary|Response Rate|Response rate is the percentage of participants with a response assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions, Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions,progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions or the appearance of one or more new lesions, stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|6 weeks|||Percentage of participants|||Number
700151|NCT00031447|Primary|Participants With Neurologic Impairment at 12 Months as Measured by a Bayley's Neuro-developmental Assessment.(Mental Scores)|Mental scores of all participants completing 6 months of blinded therapy as measured by the Bayleys neuro-developmental assessment at 12 months. Scores are classified as the following: less than or equal to 115 suggests accelerated performance; 85 - 114 suggests development within normal limits; 70 - 84 suggests mildly delayed development and less than or equal to 69 suggests significant delayed development.|At 12 months of life.|Two of 4 subjects receiving placebo and completing 6 months of placebo, and 2 of 8 subjects receiving acyclovir and completing 6 months of acyclovir did not complete the 12 month Bayley's Neuro-developmental Assessment(mental); therefore, 2 placebo subject and 6 acyclovir subjects are included in the analysis.||Participants|||Number
700152|NCT00031447|Secondary|Two or Fewer Episodes of Cutaneous Recurrence of HSV Disease Post-randomization During the Initial 12 Months of Life.|Number of participants experiencing 2 or fewer HSV recurrences during the first 12 months of life as measured by assessments and reports at study visits.|post randomization - 12 months|||participants|||Number
700153|NCT00031447|Secondary|Detection of Herpes Simplex Virus (HSV) DNA in the Cerebrospinal Fluid (CSF) by Polymerase Chain Reaction (PCR) at Anytime During the Initial 12 Months of Life.|Number of participants with positive herpes simplex virus (HSV) DNA by polymerase cahin reaction (PCR) in the cerebrospinal fluid of subjects assessed during the initial 12 months of life.|post randomization at 12 months|||Participants|||Number
700154|NCT00031447|Primary|Participants With Neurologic Impairment at 12 Months as Measured by a Bayley’s Neuro-developmental Assessment.(Motor Scores)|Motor scores of all participants completing 6 months of blinded therapy as measured by the Bayleys neuro-developmental assessment at 12 months. Scores are classified as the following: greater than or equal to 115 suggests accelerated performance; 85 - 114 suggests development within normal limits; 70 - 84 suggests mildly delayed development and less than or equal to 69 suggests significant delayed development.|At 12 months of life.|Three of 4 subjects receiving placebo and completing 6 months of placebo, and 2 of 8 subjects receiving acyclovir and completing 6 months of acyclovir did not complete the 12 month Bayley's Neuro-developmental Assessment (motor score); therefore, 1 placebo subject and 6 acyclovir subjects are included in the analysis.||Participants|||Number
700155|NCT00031460|Primary|Participants With Neurologic Impairment at 12 Months as Measured by Bayley's Neuro-developmental Assessment.(Mental Scores)|Mental scores of all subjects completing 6 months of blinded therapy as measured by the Bayleys neuro-developmental assessment at 12 months. Scores are classified as the following: greater than or equal to 115 suggests accelerated performance; 85 - 114 suggests development within normal limits; 70 - 84 suggests mildly delayed development; and less than or equal to 69 suggests significant delayed development.|At 12 months of life.|||participants|||Number
700156|NCT00031460|Secondary|Detection of Herpes Simplex Virus (HSV) DNA in the Cerebrospinal Fluid (CSF) by PCR at Anytime During the Initial 12 Months of Life.|Number of participants assessed to have a positive herpes simplex virus (HSV) DNA by polymerase chain reaction (PCR) in the cerebrospinal fluid (CSF) at any time during their initial 12 months of life after treatment. The PCR is a technique to help visualize copies of a piece of DNA.|post randomization - 12 months|||participants|||Number
701584|NCT00054717|Secondary|Virologic Response (VL < 400 Copies/ml) at Week 32|Percentage of participants with Viral Load < 400 copies/mL|week 32|||Percentage of participants|||Number
700158|NCT00031460|Primary|Participants With Neurologic Impairment at 12 Months as Measured by a Bayley’s Neuro-developmental Assessment (Motor Scores).|Motor scores of all participants completing 6 months of blinded therapy as measured by the Bayleys neuro-developmental assessment at 12 months. Scores are classified as the following: greater than or equal to 115 suggests accelerated performance; 85 - 114 suggests development within normal limits; 70 - 84 suggests mildly delayed development; and less than or equal to 69 suggests significant delayed development.|At 12 months of life.|||participants|||Number
700166|NCT00031551|Other Pre-specified|Pilot Study: Percentage of Participants Using Word Descriptors of Sensory and Affective Pain Selected by Subjects on Day 9 (+/- 24 Hours) After Conditioning Chemotherapy|Participants selected from 14 word descriptors of sensory (S) pain and 11 word descriptors of affective (A) pain.|day 9 (+/- 24 hours) after conditioning chemotherapy|One subject was in critical condition at day 9 after CT, preventing data collection at this time||percentage of participants|||Number
700167|NCT00031551|Other Pre-specified|Pilot Study: Mean Ratings of Oral Mucositis-related Oropharyngeal Pain Intensity on Day 9 (+/- 24 Hours) After Conditioning Chemotherapy (CT)|Subjects rated pain using the Painometer, a hand-held tool with a visual analogue scale to rate overall pain intensity and a list of 14 sensory and 11 affective pain descriptors ranked by intensity values from 1 - 5. Subjects look at the list of sensory and affective words and select words that describe their pain, including Oral Pain and Oral Pain with Swallowing. . The weighted scores assigned to the words are added to obtain a pain intensity score for the sensory and the affective components. The overall pain intensity is measured on a visual analogue scale which has a range of 1 - 10 with high scores indicating higher pain intensity. The sensory and affective pain scores are otained by adding all of the respective intensity values. The range of possible sensory scores is from 0 - 48 and the range of possible affective scores is from 0 - 37. The sensory and affective scores may be added together to obtain the total pain intensity score, which may range from 0 - 85.|Day 9 (+/- 24 hours) after conditioning chemotherapy|One subject was in critical condition at day 9 after CT, preventing data collection at this time||units on a scale||Standard Deviation|Mean
700168|NCT00031551|Secondary|What is the Toxicity of an Etanercept Mouthwash Used for the Treatment of Autologous or Allogeneic Peripheral Blood Stem Cell Transplant or Bone Marrow Transplant Treatment -Related Stomatitis?|Toxicity will be measured by the incidence of adverse events.|2 years|||event|||Number
700169|NCT00031551|Primary|What is the Clinical Efficacy of an Etanercept Mouthwash Used for the Treatment of Autologous or Allogeneic Peripheral Blood Stem Cell Transplant or Bone Marrow Transplant Treatment-related Stomatitis?|Clinical efficacy will be determined by measurement of stomatitis grade and oropharyngeal pain.|2 years|Participants withdrew and analyses were terminated before any data collected.|||||
700170|NCT00031694|Secondary|Bryostatin 1 Pharmacokinetics||Week 1||||||
700171|NCT00031694|Secondary|Overall Survival|Computed using the Kaplan-Meier estimator.|Up to 8 years||||||
700172|NCT00031694|Secondary|Adverse Events|95% confidence intervals will be computed and presented.|Up to 8 years||||||
700175|NCT00038103|Secondary|Time to Treatment Failure|Time from randomization to first objective tumor recurrence or progression or death due to any cause or withdrawal from study treatment due to any reason, whichever was the earliest.|Baseline, Weeks 8, 16, 24, every 12 weeks from Week 24 up to Week 108, and every 24 weeks thereafter until 9 months following LSLV|Evaluable population||Weeks||95% Confidence Interval|Median
700176|NCT00038103|Secondary|Time to Tumor Progression|Time from randomization to first objective tumor recurrence or progression or death due to tumor progression in the absence of previous documentation of tumor progression.|Baseline, Weeks 8, 16, 24, every 12 weeks beyond Week 24 up to Week 108 and every 24 weeks thereafter until 9 months following LSLV|Evaluable population||weeks||95% Confidence Interval|Median
700177|NCT00038103|Secondary|Duration of Long-Term SD|Time from start of treatment until the first objective documentation of tumor progression or death due to tumor progression in the absence of previous documentation of tumor progression in subjects with long-term SD.|Baseline, Weeks 8, 16, 24, every 12 weeks from Week 24 up to Week 108, and every 24 weeks thereafter until 9 months LSLV|Evaluable population. Number of participants analyzed = number of subjects with long-term SD.||weeks||95% Confidence Interval|Median
700178|NCT00038103|Secondary|Duration of Objective Response (in Subjects With CR or PR)|Time from the first objective documentation of response until the first objective documentation of tumor progression.|Baseline, Weeks 8, 16, 24, every 12 weeks beyond 24 up to Week 108, and every 24 weeks thereafter until 9 months following LSLV|Evaluable population. Number of participants analyzed = number of subjects with objective response.||weeks||95% Confidence Interval|Median
700179|NCT00038103|Secondary|Duration of Clinical Benefit|Time from randomization date to first objective documentation of tumor progression or death due to tumor progression in the absence of previous documentation of tumor progression.|Baseline, Weeks 8, 16, 24, every 12 weeks from Week 24 up to Week 108, and every 24 weeks thereafter until 9 months following LSLV|Evaluable population. Number of participants analyzed = number of subjects with clinical benefit.||weeks||95% Confidence Interval|Median
700180|NCT00038103|Secondary|Number of Subjects With Objective Response|Objective tumor response includes subjects with CR or PR according to RECIST.|Baseline, Weeks 8, 16, 24, every 12 weeks from Week 24 up to Week 108, and every 24 weeks thereafter until 9 months following LSLV|Evaluable population||participants|||Number
700181|NCT00038103|Primary|Number of Subjects With Clinical Benefit|Clinical benefit was based on objective tumor assessments made according to Response Evaluation Criteria (RECIST) system of unidimensional evaluation. Includes subjects with complete response (CR), partial response (PR), and long term disease stabilization (SD) for at least 24 weeks.|Baseline, Week 8, 16, 24, and every 12 weeks beyond 24 up to Week 108 and every 24 weeks thereafter until 9 months following last subject last visit (LSLV)|Evaluable population||participants|||Number
700182|NCT00040664|Primary|Least Squares Mean of Plasma APV Parameter: Ctau|A blood sample was drawn on Week 4 over 24 hours (at 0, 1, 2, 4, 8, 12, and 24 hours post dosing). Ratio of geometric least squares mean (90% CI) are presented. Ctau=trough concentration. PK Parameters for QD and BID are compared with Historical adult data. Least squares mean (LSM) are the group means after having controlled for a covariate (i.e., holding it constant at some typical value of the covariate, such as its mean value). LSM is calculated by taking the average of the means within a treatment.|0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4.|The PK Parameter Population included all participants who underwent plasma PK sampling and provided full PK profiles with evaluable plasma APV PK parameter data; thus, the sample sizes were limited. Results are stratified by age cohort and formulation since these factors can impact PK profiles.||microgram per milliliter||95% Confidence Interval|Least Squares Mean
700183|NCT00040664|Primary|Least Squares Mean of Plasma APV Parameter: Cmax|A blood sample was drawn on Week 4 over 24 hours (at 0, 1, 2, 4, 8, 12, and 24 hours post dosing). Ratio of geometric least squares mean (90% CI) are presented. Ctau=trough concentration. PK Parameters for QD and BID are compared with Historical adult data. Least squares mean (LSM) are the group means after having controlled for a covariate (i.e., holding it constant at some typical value of the covariate, such as its mean value). LSM is calculated by taking the average of the means within a treatment.|0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4.|The PK Parameter Population included all participants who underwent plasma PK sampling and provided full PK profiles with evaluable plasma APV PK parameter data; thus, the sample sizes were limited. Results are stratified by age cohort and formulation since these factors can impact PK profiles.||micrograms/milliliters||95% Confidence Interval|Least Squares Mean
700184|NCT00040664|Primary|Least Squares Mean of Plasma APV Parameter: AUC0-tau|A blood sample was drawn on Week 4 over 24 hours (at 0, 1, 2, 4, 8, 12, and 24 hours post dosing). Ratio of geometric least squares mean (90% CI) are presented. Ctau=trough concentration. PK Parameters for QD and BID are compared with Historical adult data. Least squares mean (LSM) are the group means after having controlled for a covariate (i.e., holding it constant at some typical value of the covariate, such as its mean value). LSM is calculated by taking the average of the means within a treatment.|0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4|The PK Parameter Population included all participants who underwent plasma PK sampling and provided full PK profiles with evaluable plasma APV PK parameter data; thus, the sample sizes were limited. Results are stratified by age cohort and formulation since these factors can impact PK profiles.||hours*micrograms/milliliters||95% Confidence Interval|Least Squares Mean
700185|NCT00040664|Primary|Geometric Mean of Steady State Plasma APV Parameter: t1/2|"Geometric mean is a type of average that indicates the central tendency of a set of values and is calculated by multiplying all the numbers in a set, and then taking the nth root of the resulting product. t1/2=elimination half-life. t1/2=elimination half-life."|0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4|The PK Parameter Population included all participants who underwent plasma PK sampling and provided full PK profiles with evaluable plasma APV PK parameter data; thus, the sample sizes were limited. Results are stratified by age cohort and formulation since these factors can impact PK profiles.||hours||95% Confidence Interval|Geometric Mean
700186|NCT00040664|Primary|Geometric Mean of Steady State Plasma APV Parameter: CL/F|"Geometric mean is a type of average that indicates the central tendency of a set of values and is calculated by multiplying all the numbers in a set, and then taking the nth root of the resulting product. CL/F=apparent plasma clearance."|0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4|The PK Parameter Population included all participants who underwent plasma PK sampling and provided full PK profiles with evaluable plasma APV PK parameter data; thus, the sample sizes were limited. Results are stratified by age cohort and formulation since these factors can impact PK profiles.||milliliters/minute||95% Confidence Interval|Geometric Mean
700187|NCT00040664|Primary|Geometric Mean of Steady State Plasma APV Parameter: CL/F|"Geometric mean is a type of average that indicates the central tendency of a set of values and is calculated by multiplying all the numbers in a set, and then taking the nth root of the resulting product. CL/F=apparent plasma clearance."|0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4|The PK Parameter Population included all participants who underwent plasma PK sampling and provided full PK profiles with evaluable plasma APV PK parameter data; thus, the sample sizes were limited. Results are stratified by age cohort and formulation since these factors can impact PK profiles.||milliliters/minute/kilogram||95% Confidence Interval|Geometric Mean
700188|NCT00040664|Primary|Median Steady State Plasma APV Tmax|tmax: time after administration of the drug when maximum concentration is reached|0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4|The PK Parameter Population included all participants who underwent plasma PK sampling and provided full PK profiles with evaluable plasma APV PK parameter data; thus, the sample sizes were limited. Results are stratified by age cohort and formulation since these factors can impact PK profiles.||hours||Full Range|Median
700189|NCT00040664|Secondary|Number of Participants With APV Resistance Associated HIV-1 RNA Genotypic Mutations and Phenotypic Resistance at Time of Virologic Failure Not Present at Baseline|A blood sample was drawn for participants failing to respond to therapy, and the mutations present in the virus were identified. For each participant, the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New mutations that developed at the time of virologic failure were tabulated by drug class. Virologic failure is defined as HIV-1 RNA greater than or equal to 400 copies/mL.|Time of virologic failure|Participants in the ITT-E Population who met the virologic failure definition. Results are stratified by previous PI experience. Participants with previous PI experience may respond differently to FPV.||Participants|||Number
700190|NCT00040664|Primary|Geometric Mean of Steady State Plasma APV Parameter: Cmax|"Geometric mean is a type of average that indicates the central tendency of a set of values and is calculated by multiplying all the numbers in a set, and then taking the nth root of the resulting product. Cmax= concentration maximum."|0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4|The PK Parameter Population included all participants who underwent plasma PK sampling and provided full PK profiles with evaluable plasma APV PK parameter data; thus, the sample sizes were limited. Results are stratified by age cohort and formulation since these factors can impact PK profiles.||micrograms/milliliter||95% Confidence Interval|Geometric Mean
700191|NCT00040664|Primary|Geometric Mean of Steady State Plasma Amprenavir (APV) Parameter: AUC(0-tau)|"Geometric mean is a type of average that indicates the central tendency of a set of values and is calculated by multiplying all the numbers in a set, and then taking the nth root of the resulting product. AUC(0-tau)=area under the concentration curve from time 0 to tau."|0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4|The Pharmacokinetic (PK) Parameter Population included all participants who underwent plasma PK sampling and provided full PK profiles with evaluable plasma APV PK parameter data; thus, the sample sizes were limited. Results are stratified by age cohort and formulation since these factors can impact PK profiles.||hours*micrograms/milliliter||95% Confidence Interval|Geometric Mean
700192|NCT00040664|Primary|Number of Participants With Grade 3 or 4 Treatment-emergent Laboratory Abnormalities|The number of participants with Grade 3 (severe) or Grade 4 (life-threatening) laboratory abnormalities while on study treatment.|Baseline through end of study (at least Week 168)|Safety Population: all participants with documented evidence of having received at least one dose of study drug||Participants|||Number
700193|NCT00040664|Primary|Number of Participants With Any Drug-related Grade 2 to 4 Adverse Event|The number of participants with drug-related adverse events coded as Grade 2 (mild), Grade 3 (severe), or Grade 4 (life-threatening).|Baseline through end of study (at least Week 168)|Safety Population: all participants with documented evidence of having received at least one dose of study drug||Participants|||Number
700194|NCT00040664|Secondary|Median Change From Baseline in CD4+ Values at Week 12, 48, 96, and 168 Visits|A blood sample was drawn to determine the CD4+ cell count at Weeks 24, 48, 96, and 168. Change from Baseline was defined as the CD4+ cell count at Weeks 24, 48, 96, and 168 minus the CD4+ cell count at Baseline.|Baseline and Weeks 12, 48, 96, and 168|ITT-E Population. Results are stratified by previous PI experience. Participants with previous PI experience may respond differently to FPV.||Cells/mm3||Inter-Quartile Range|Median
700195|NCT00040664|Secondary|Median Change From Baseline HIV-1 RNA Values at Weeks 12, 48, 96, and 168 Visits|A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Weeks 12, 24, 48, 96, and 168. Change from Baseline was defined as the HIV-1 RNA level at Weeks 12, 24, 48, 96, and 168 minus the HIV-1 RNA level at Baseline.|Baseline and Weeks 12, 48, 96, and 168|ITT-E Population. Results are stratified by previous PI experience. Participants with previous PI experience may respond differently to FPV.||log10 copies/mL||Inter-Quartile Range|Median
700196|NCT00040664|Secondary|Percentage of Participants With HIV-1 RNA <400 Copies Per mL at Weeks 12, 48, 96, and 168 (Time to Loss of Virologic Response [TLOVR] Analysis)|A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies per milliliter (mL) at Weeks 12, 48, 96, and 196. The percentage of participants with HIV-1 RNA <400 copies/mL at Weeks 12, 48, 96, 168 was determined by the TLOVR algorithm with stratification by the six randomization strata. TLOVR analysis categorizes participants by treatment response. Responders were participants with confirmed viral load <400copies/mL on two consecutive visits.|Weeks 12, 48, 96, and 168|The Intent-to-Treat Exposed (ITT [E]) Population consisted of all subjects with documented evidence of having received at least one dose of study drug. Results are stratified by previous protease inhibitor (PI) experience. Participants with previous PI experience may respond differently to FPV.||percentage of participants|||Number
700197|NCT00040664|Primary|Number of Participants Who Discontinued Treatment Due to Adverse Events|The number of participants who prematurely discontinued study drug due to adverse events was tabulated. Data are summarized by individual adverse event.|Baseline through end of study (at least Week 168)|Safety Population: all participants with documented evidence of having received at least one dose of study drug||Participants|||Number
700238|NCT00041938|Other Pre-specified|Event Rate Per 100 Patient-years for Ischemic Stroke|Time, in years, from date of randomization to date of ischemic stroke component of primary composite outcome, up to 6 years. Event rate per 100 patient years = 100*(number of subjects with ischemic stroke)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.|From date of randomization to date of ischemic stroke component of primary composite outcome, up to 6 years|Intent-to-treat||rate per 100 patient years|||Number
700198|NCT00040742|Secondary|Average Nausea Severity|"Nausea evaluated on a 7-point semantic rating scale anchored by 1 = Not at all nauseated and by 7 = Extremely nauseated. Acute nausea calculated as the average of the Day 1 Evening and Night nausea ratings.
Change from post-intervention (cycle 2 of chemotherapy) - baseline (cycle 1 of chemotherapy) of average acute nausea used as the outcome measure.
Negative values for this outcome are favorable."|3-4 days on study drug|Eligible patients 18 years of age or older, able to understand English, diagnosed with cancer, may have received more than one chemotherapy cycle and scheduled for at least three additional cycles; randomization stratified by CCOP site. A computer-generated random numbers table assigned patients to one of four treatment arms.||units on a scale||Standard Error|Mean
700199|NCT00040742|Primary|Change From Baseline of Peak Acute Nausea|"Nausea evaluated on a 7-point semantic rating scale anchored by 1 = Not at all nauseated and by 7 = Extremely nauseated. Acute nausea calculated as the maximum of the Day 1 Evening and Night nausea ratings.
Change from post-intervention (cycle 2 of chemotherapy) - baseline (cycle 1 of chemotherapy) of peak acute nausea used as the outcome measure.
Negative values for this outcome are favorable."|3-4 days on study drug|Eligible patients 18 years of age or older, able to understand English, diagnosed with cancer, may have received more than one chemotherapy cycle and scheduled for at least three additional cycles; randomization stratified by CCOP site. A computer-generated random numbers table assigned patients to one of four treatment arms.||units on a scale||Standard Deviation|Mean
700200|NCT00040846|Secondary|Evaluate the Risk for Disease Progression and Relapse|Percentage patients who relapsed/progressed within 1 year post-transplant.|1 year after transplant|||percentage of participants|||Number
700201|NCT00040846|Secondary|Evaluate the Risk/Incidence of Infections|Percentage patients who experienced infections within 100 days post-transplant.|100 days after transplant|||percentage of participants|||Number
700202|NCT00040846|Primary|Determine Whether Engraftment Can be Maintained With a Single Dose Fludarabine, DLI and Continued MMF/CSP, Defined as Rejection Rate < 20%.|Mixed chimerism will be defined as the detection of donor T cells (CD3+) and granulocytes (CD 33+), as a proportion of the total T cell and granulocyte population, respectively, of greater than 5% and less than 95% in the peripheral blood. Full donor chimerism is defined as > 95% donor CD3+ T cells.|100 days after transplant|||percentage of participants|||Number
700203|NCT00040846|Primary|Evaluate the Risk of Occurrence of Acute and Chronic GVHD|"Percentage patients who developed acute/chronic GVHD.
aGVHD Stages
Skin:
a maculopapular eruption involving < 25% BSA
a maculopapular eruption involving 25 - 50% BSA
generalized erythroderma
generalized erythroderma with bullous formation and often with desquamation
Liver:
bilirubin 2.0 - 3.0 mg/100 mL
bilirubin 3 - 5.9 mg/100 mL
bilirubin 6 - 14.9 mg/100 mL
bilirubin > 15 mg/100 mL
Gut:
Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall.
aGVHD Grades Grade III: Stage 2 - 4 gastrointestinal involvement and/or +2 to +4 liver involvement, with or without a rash Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death"|1 year after transplant|||percentage of participants|||Number
700204|NCT00040846|Primary|Evaluate the Risk of Transplant Related Mortality.|Percentage patients with Day 100 transplant related mortality.|100 days after transplant|||percentage of participants|||Number
700205|NCT00040937|Primary|Overall Survival||4-7 years|||proportion surviving at 4 years||95% Confidence Interval|Number
700206|NCT00040937|Secondary|Assess Toxicity of Thalidomide/Dexamethasone as a Pre-transplant Induction Regimen.|To assess Grade 3-5 AE related to thalidomide/dexamethasone when administered as a pre-transplant induction regimen.|Induction|All participants receiving at least one dose of induction therapy||Participants|||Number
700207|NCT00041067|Secondary|Toxicity|Number of patients for whom highest grade of toxicity observed during treatment. Only adverse events that are possibly, probably or definitely related to study drug are reported.|toxicities assessed every 3 weeks during treatment, for up to 3 years if no progession|Eligible patients||Participants|||Number
700208|NCT00041067|Secondary|Progression-free Survival||2 years|All eligible patients||months||95% Confidence Interval|Median
700209|NCT00041067|Secondary|Response Rate (Complete and Partial, Confirmed and Unconfirmed)|Response was measured by the RECIST criteria. A patient was considered a responder if there was confirmed or unconfirmed partial or complete response. All others were considered non-responders even if the patient was technically not assessable due to different measurement techniques at the two time points.|response assessed after every 3 cycles (9 weeks) during treatment for up to 3 years if no progession|patients with Response Evaluation Criteria in Solid Tumors measurable disease||participants|||Number
700210|NCT00041067|Primary|Survival at 1 Year||1 year|All eligible patients||percentage of patients||95% Confidence Interval|Number
700211|NCT00041080|Primary|Median Progression-free Survival||from enrollment onto the study until first disease progression or death due to any cause|||months||95% Confidence Interval|Median
700212|NCT00041119|Secondary|Overall Survival (OS) for 4 vs. 6 Cycles|To determine if longer therapy, 12 weeks, is superior to shorter therapy, 8 weeks, of either CA or paclitaxel for overall survival for women with primary breast cancer with 0-3 positive axillary lymph nodes. An assessment of the superiority of 6 cycles over 4 cycles will be conducted. This analysis combines Arm I and Arm III together, and Arm II and Arm IV together.|from baseline up to 4 years|All patients that were eligible and received treatment were analyzed.||percentage of patients at 4 years|||Number
700213|NCT00041119|Secondary|Local Control|Local control will be calculated as the cumulative incidence of first local relapse.|from baseline up to 15 years|All patients that were eligible and received treatment were analyzed.||years||Full Range|Median
700214|NCT00041119|Secondary|Time to Distant Metastases|Local control and distant metastasis will be calculated as the cumulative incidence of first local relapse and first distant metastasis, respectively.|from baseline up to 15 years|All patients that were eligible and received treatment were analyzed.||years||Full Range|Median
700215|NCT00041119|Secondary|Adverse Events|To compare toxicities of short course CA and paclitaxel with long course CA and paclitaxel as adjuvant therapy for women with 0-3 positive axillary lymph node breast cancer. The percentage of patients that received a grade 3 or higher hematologic event will be reported here. We will be combining arm I with arm III, as well as arm II with arm IV. For a complete list of adverse events, please refer to the adverse events section.|from baseline up to 6 weeks post-treatment|3754 patients were considered evaluable for toxicity that occurred during treatment.||percentage of patients|||Number
700216|NCT00041119|Secondary|Overall Survival (OS)|To determine the equivalence of paclitaxel to CA as adjuvant therapy for women with 0-3 positive axillary lymph nodes, for overall survival. OS will be measured from study entry until death due to any cause. Survivors will be censored at the date of last follow-up.. The trial is designed to show the equivalence of the experimental agent T with the standard agent combination CA, thus the 4 and 6 course arms of each drug will be combined to conduct this analysis.|from baseline up to 5 years|All patients that were eligible and treated for the study were evaluated.||percentage of participants at 5 years|||Number
700217|NCT00041119|Primary|Duration of Disease Free Survival (RFS)|To determine the equivalence of paclitaxel to CA as adjuvant therapy for women with 0-3 positive axillary lymph nodes, for disease-free survival. Objective progression is defined as the appearance of local (chest wall, axillary, supraclavicular nodes) or distant metastases. The trial is designed to show the equivalence of the experimental agent T with the standard agent combination CA, thus the 4 and 6 course arms of each drug will be combined to conduct this analysis.|from baseline up to 6.4 years|All eligible patients were treated and analyzed.||months||95% Confidence Interval|Median
700218|NCT00041119|Primary|Relapse Free Survival (RFS) 4 vs. 6 Cycles|To determine if longer therapy, 12 weeks, is superior to shorter therapy, 8 weeks, of either CA or paclitaxel for relapse-free survival for women with primary breast cancer with 0-3 positive axillary lymph nodes. An assessment of the superiority of 6 cycles over 4 cycles will be conducted. This analysis combines Arm I and Arm III together, and Arm II and Arm IV together.|from baseline up to 4 years|All patients that were eligible and received treatment were analyzed. 700 patients were not included due to the timing that the analysis was performed.||years||Full Range|Median
700219|NCT00041132|Secondary|Overall Survival|Overall Survival rate at 1 year. Time to death is from date of registration to date of death due to any cause.|assessed after cycle 4, after completion of treatment, then every 3 months for 2 years, then every 6 months thereafter until 5 years|||percentage of participants||95% Confidence Interval|Number
700220|NCT00041132|Secondary|Response|Complete (CR), complete unconfirmed (CRU) and partial responses (PR). CR is complete disappearance of all measurable and non-measurable disease with the exception of nodes; no new lesions; previously enlarged organs must have regressed in size; and if bone marrow positive at baseline, it must be negative. CRU is complete disappearance of all measurable and non-measurable disease; regressed, non-palpable organs; and one or more exceptions not qualifying for CR (see protocol section 10). PR applies to patients with at least one measurable lesion who do not qualify for CR or CRU. PR is a 50% decrease in sum of products of greatest diameters (SPD) for up to six identified dominant lesions identified at baseline; no new lesions; no increase in the size of liver, spleen or other nodes; and splenic and hepatic nodules must have regressed in size by at least 50% in SPD.|assessed after cycle 4 and after completion of treatment (168 days)|||participants|||Number
700221|NCT00041132|Primary|Progression-free Survival|Progression-Free Survival (PFS) rate at 1 year. PFS measured from date of registration to date of first observation of progressive disease or death due to any cause. Progressive disease is a 50% increase in the sum of products of greatest diameters (SPD) of target measurable lesions over the smallest sum observed if a complete response (confirmed, or unconfirmed) was not previously achieved; appearance of a new lesion/site; unequivocal progression of non-measurable disease; or death due to disease without prior documentation of progression.|assessed after cycle 4, after completion of treatment, then every 3 months until 1 year after registration|||percentage of participants||95% Confidence Interval|Number
700222|NCT00041392|Primary|Cognitive Function|To characterize cognitive function over time, while minimizing potential redundancy in the cognitive measures, a factor analysis was performed on the cognitive test scores from baseline. We chose a four-factor solution, which represents 4 cognitive domains: verbal memory, abstraction and visuo-spatial orientation (executive function), visual memory and attention and concentration. To quantify overall cognitive function, a baseline cognitive index was first calculated as the mean of the 4 preoperative domain scores. The cognitive index score has a mean of zero and standard deviation of 0.5. Thus, any positive score is above the mean, any negative score is below the mean, and a score of 0.5 represents 1 SD above the mean. A continuous change score was then calculated by subtracting the baseline from the 6-week cognitive index. Negative scores indicate decline and positive scores indicate improvement.|Measured at baseline and 6 weeks|||Continuous cognitive change score||Standard Deviation|Mean
700223|NCT00041470|Secondary|To Measure the Qualitative and Quantitative Toxicity of This Regimen.||<=18 months|||Participants|||Count of Participants
700224|NCT00041470|Primary|To Measure Response Rates, Time to Progression and Survival in Patients so Treated.||1 year|||Participants|||Count of Participants
700225|NCT00041717|Primary|Double-blind Change From Baseline in Subject's Global Impression (SGI) of Treatment|This questionnaire asked the patient to evaluate the effects of investigational drug on his/her quality of life during the preceding week using a 7-point scale (from 1=terrible to 7=delighted). A positive change score in SGI indicates improved outcome.|Baseline (visits 2,3) average score days 7,14 and double blind treatment period (visits 4-7) average score days 28-98|ITT||units on a scale||Standard Error|Mean
700226|NCT00041717|Primary|Double-blind Change From Baseline in Ashworth Score Evaluating Spasticity|The Ashworth Score is the average rating (based on a scale of 1 to 5) of four lower extremity muscle groups; left and right knee flexors and extensors (hamstrings and quadriceps muscles). A higher Ashworth Score indicates a greater degree of abnormal muscle tone (spasticity) and a negative change in score indicates improvement.|Baseline (visits 2,3) average score days 7,14 and double blind treatment period (visits 4-7) average score days 28-98|Intent to treat (ITT) population||units on a scale||Standard Error|Mean
700227|NCT00041756|Primary|Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score at 1 Year|The symptomatic primary efficacy endpoint is the change in total WOMAC scores after 1 year of treatment. The WOMAC consists of 24 items divided into 3 subscales: Pain (5 items), Stiffness (2 items), Physical Function (17 items). The WOMAC uses descriptors for all items: none, mild moderate, severe, and extreme (corresponding to an ordinal scale of 0-4.) Scores are summed for items in each subscale, with possible ranges as follows: pain=0-20, stiffness=0-8, physical function=0-68. The total WOMAC score is created by summing the items for all three subscales (min=0, max=96)|baseline and 12 months|An intent-to-treat (ITT) analysis was conducted on all patients who were randomized and took at least one dose of study drug. Any missing data for these patients was not imputed in the primary analysis.||Scores on a scale||Standard Error|Least Squares Mean
700228|NCT00041756|Primary|Change in Minimum Joint Space Width in the Medial Compartment of the Tibiofemoral Joint of the Signal Knee After 1 Year of Treatment|The structural primary efficacy endpoint is the 1-year change from baseline in minimum joint space width (JSW) in the medial compartment of the tibiofemoral joint of the signal knee, as measured by microfocal knee radiographs obtained in the semi-flexed position.|baseline and 12 months|"An intent-to-treat (ITT) analysis was conducted on all patients who were randomized and took at least one dose of study drug. Any missing data for these patients was not imputed in the primary analysis.
analysis."||mm||Standard Error|Least Squares Mean
700229|NCT00041938|Other Pre-specified|Rate Per 100 Patient-years of Minor Hemorrhage.|Rate per 100 patient years of minor hemorrhage. Includes all minor hemorrhages. Minor hemorrhage was defined as any non-major hemorrhage. Event rate per 100 patient years = 100*(number of minor hemorrhage events)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1)of all randomized patients / 365.25.|From date of randomization until the end of scheduled follow-up, up to 6 years|Intent-to-treat||events per 100 patient-years|||Number
700230|NCT00041938|Other Pre-specified|Rate Per 100 Patient Years of Major Hemorrhage|Rate/100 patient-years of major hemorrhage. Includes all major hemorrhages in any patient. Major hemorrhage was defined as intracerebral, epidural, subdural, subarachnoid, spinal intramedullary, or retinal hemorrhage; any other bleeding causing a decline in the hemoglobin level of more than 2 g per deciliter in 48 hours; or bleeding requiring transfusion of 2 or more units of whole blood, hospitalization, or surgical intervention. Event rate per 100 patient years = 100*(number of major hemorrhage events)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.|From date of randomization until end of scheduled follow-up, up to 6 years|Intent-to-treat||events per 100 patient years|||Number
700231|NCT00041938|Other Pre-specified|Event Rate Per 100 Patient Years of Death Component of Secondary Composite Outcome|Time, in years, from randomization to death component of secondary composite outcome. This measure counts only deaths that were not preceded by heart failure hospitalization, myocardial infarction, ischemic stroke, or intracerebral hemorrhage. Event rate per 100 patient years = 100*(number of subjects who died)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.|From date of randomization to date of death component of secondary composite outcome, up to 6 years|Intent-to-treat||events per 100 patient years|||Number
700232|NCT00041938|Other Pre-specified|Event Rate Per 100 Patient Years of Intracerebral Hemorrhage Component of Secondary Composite Outcome|Time, in years, from date of randomization to date of intracerebral hemorrhage component of secondary composite outcome. Includes only intracerebral hemorrhages not preceded by myocardial infarction or heart failure hospitalization. Event rate per 100 patient years = 100*(number of subjects with intracerebral hemorrhage)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.|From date of randomization to date of intracerebral hemorrhage component of secondary composite outcome, up to 6 years|Intent-to-treat||events per 100 patient years|||Number
700233|NCT00041938|Other Pre-specified|Event Rate Per 100 Patient Years of Ischemic Stroke Component of Secondary Composite Outcome|Ischemic stroke component of secondary composite endpoint. Includes only ischemic strokes that were not preceded by a myocardial infarction or heart failure hospitalization. The number of ischemic strokes that are components of the secondary outcome does not therefore match the number of ischemic strokes that are components of the primary outcome. Event rate per 100 patient years = 100*(number of subjects with ischemic stroke)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1)of all randomized patients / 365.25.|From date of randomization to date of ischemic stroke component of secondary composite outcome, up to 6 years|Intent-to-treat.||events per 100 patient years|||Number
700234|NCT00041938|Other Pre-specified|Event Rate Per 100 Patient Years of Heart Failure Hospitalization Component of Secondary Composite Outcome.|Time, in years, from date of randomization to date of heart failure hospitalization, up to 6 years. Includes hospitalizations for heart failure during follow-up that were not preceded by myocardial infarction. Event rate per 100 patient years = 100*(number of subjects with heart failure hospitalization)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.|From date of randomization to date of heart failure hospitalization component of secondary composite outcome, up to 6 years|Intent-to-treat.||events per 100 patient years|||Number
700235|NCT00041938|Other Pre-specified|Event Rate Per 100 Patient Years of Myocardial Infarction Component of Secondary Composite Outcome|Time, in years, from date of randomization to date of myocardial infarction, up to 6 years. Includes only myocardial infarctions that occurred during follow-up, before any heart failure hospitalization. Event rate per 100 patient years = 100*(number of subjects with myocardial infarction)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.|From date of randomization to date of myocardial infarction component of secondary composite outcome, up to 6 years|Intent-to-treat||events per 100 patient years|||Number
700236|NCT00041938|Other Pre-specified|Event Rate Per 100 Patient-years for Death|Time, in years, from date of randomization to date of death component of primary composite outcome. Event rate per 100 patient years = 100*(number of subjects who died)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.|From date of randomization to date of death component of primary composite outcome, up to 6 years|Intent-to-treat||events per 100 patient-years|||Number
700237|NCT00041938|Other Pre-specified|Event Rate Per 100 Patient-years for Intracerebral Hemorrhage|Time, in years, from date of randomization to date of intracerebral hemorrhage component of primary composite outcome. Event rate per 100 patient years = 100*(number of subjects with intracerebral hemorrhage)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.|From date of randomization to date of intracerebral hemorrhage component of primary composite outcome, up to 6 years|Intent-to-treat||rate per 100 patient years|||Number
701308|NCT00056407|Secondary|Number of Participants Starting Alpha Blockers to Control Benign Prostatic Hyperplasia (BPH) Symptoms|Medication taken during the study, including alpha blockers, was recorded at each 6-month study visit and during phone calls that occurred 3 months after each visit.|Years 1-2, Overall (Years 1-4)|Efficacy Population||participants|||Number
700239|NCT00041938|Secondary|Event Rate Per 100 Patient-years for Composite Endpoint of Hospitalization for Heart Failure, Myocardial Infarction, Ischemic Stroke, Intracerebral Hemorrhage, or Death.|"The time, in years, from date of randomization to the date of the first to occur of hospitalization for heart failure, myocardial infarction, ischemic stroke, intracerebral hemorrhage, or death, up to 6 years.
Event rate per 100 patient years = 100*(number of subjects with event)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25."|From randomization to the first to occur of hospitalization for heart failure, myocardial infarction, ischemic stroke, intracerebral hemorrhage, or death, up to a maximum of 6 years.|Intent-to-treat analysis: all enrolled patients were analyzed.||events per 100 patient-years|||Number
700240|NCT00041938|Primary|Event Rate Per 100 Patient Years for Composite Endpoint of Ischemic Stroke, Intracerebral Hemorrhage, or Death|The time, in years, from randomization to the first to occur of ischemic stroke, intracerebral hemorrhage, or death, up to a maximum of 6 years. Event rate per 100 patient years = 100*(number of subjects with event)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.|From date of randomization until the date of the first to occur of ischemic stroke, intracerebral hemorrhage, or death, up to 6 years|Intent-to-treat analysis: all enrolled patients were analyzed.||events per 100 patient-years|||Number
700241|NCT00042224|Primary|Response Rates in the ECT Plus Clozapine Group vs the Pharmacotherapy Group.|Response is defined as 40% reduction of symptoms in the psychotic symptom sub-scale (hallucinatory behavior, suspiciousness, conceptual disorganization, and unusual thought of content) of the Brief Psychiatric Rating Scale (BPRS) at the end of the 8-week study. BPRS assesses psychotic symptoms on a 18-item scale. The severity of each item is rated on a continuous scale from 1-7, with 1 being the least severe and 7 being most severe. Participants included in the study, at baseline had at least a moderate score of 4 on one of the four psychotic symptom sub-scale or a score of 12 on all four of these items combined (ranges 4 -28, with higher scores indicative of greater severity). A reduction of symptoms would be a sub-scale score which is 40% less than participants baseline score. If a participant enters the study with a sub-scale score of 15, to be considered a responder (at least a 40% reduction in symptoms score) his/her score must decrease by at least 6 points and be 9 or less.|8 Weeks|inpatient units of the Zucker Hillside Hospital at Glen Oaks, N.Y., and the Pilgrim State Psychiatric Center in Long Island, N.Y.||Percentage of responders|||Number
700242|NCT00042432|Secondary|Percentage Change From Baseline in Mean iPTH During the Efficacy Assessment Phase|Percentage change from baseline in mean intact parathyroid hormone (iPTH) during the efficacy assessment phase|Baseline, efficacy assessment phase (weeks 12-18)|All randomized participants, using Last Value Carried Forward (LVCF) imputation||Percent change||Standard Error|Mean
700243|NCT00042432|Primary|Reduction in Mean iPTH of ≥ 30% During the Efficacy Assessment Phase|Reduction in mean intact parathyroid hormone (iPTH) of ≥ 30% within the participant during the efficacy assessment phase|Efficacy assessment phase (weeks 12-18)|All randomized participants, using Last Value Carried Forward (LVCF) imputation||Participants|||Number
700244|NCT00042939|Secondary|Proportion of Patients With Thromboembolic Events|To determine the rate of thromboembolic events in this population when prophylactic enoxaparin sodium is administered.|Assessed every 6 weeks while on treatment and for 30 days after the end of treatment|Eligible and treated patients||Proportion of participants||90% Confidence Interval|Number
700245|NCT00042939|Secondary|Epidermal Growth Factor Receptor (EGFR) Status|EGFR expression was be evaluated by staining 5-micron paraffin sections of tumor biopsies with anti-EGFR clone 2-18C9 (DAKO Corporation, Carpinteria, CA) using an indirect immunoperoxidase technique according to the instructions provided by DAKO. In brief, this includes an antigen retrieval pretreatment, the blocking of endogenous peroxidase activity, incubation with anti-EGFR antibody or a negative reagent control, staining with a detection system, visualization, and coverslipping.|Original tumor tissue samples submitted within one month of patient randomization|Eligible and treated patients with EGFR stain results available.||participants|||Number
700246|NCT00042939|Secondary|Overall Survival|Overall survival was defined as time from registration to death from any cause.|Assessed every 3 months for 2 years and then every 6 months for 1 year|Eligible patients who began treatment.||months||90% Confidence Interval|Median
700247|NCT00042939|Secondary|Progression-free Survival|"Progression-free survival was defined as the shorter of:
The time from registration to progression. or
The time from registration to death without documentation of progression given that the death occured within 4 months of the last disease assessment without progression (or registration, whichever is more recent).
Progression is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s) or unequivocal progression of existing nontarget lesions."|Assessed every 3 months for 2 years and then every 6 months for 1 year|Eligible patients who began treatment.||months||90% Confidence Interval|Median
700248|NCT00042939|Primary|Proportion of Patients With Objective Response Evaluated by RECIST (Solid Tumor Response Criteria)|"Per RECIST criteria, Complete response (CR)= disappearance of all target and nontarget lesions Partial response (PR)= >=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits.
Objective response = CR + PR"|Assessed every 12 weeks until progression|Eligible patients who began treatment were included in the analysis.||Proportion of participants||90% Confidence Interval|Number
700249|NCT00042991|Secondary|Number of Patients With Epidermal Growth Factor Receptor (EGFR) Amplification|Epidermal growth factor receptor (EFGR) is a protein found on the surface of cells to which epidermal growth factor (EGF) binds. When EGF attaches to EGFR, it activates the enzyme tyrosine kinase, triggering reactions that cause the cells to grow and multiply.|Pre-treatment|Epidermal growth factor receptor is only possible with tumor sample, which is only potentially available from supratentorial malignant glioma patients treated on Stratum-1B and Stratum-2. Of 10 Stratum-1B and 3 Stratum-2 patients (n=13), tumor material was available from 11 patients (8 in Stratum-1A and 3 in Stratum-2).||Participants|||Number
700277|NCT00043186|Secondary|Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 24|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 24 calculated using ((Month 24 value - Baseline value) / Baseline value ) x 100.|Baseline and 24 months|Randomized participants with non-missing Baseline and non-missing value at Month 24.||Percent change||Standard Error|Least Squares Mean
700250|NCT00042991|Secondary|Gefitinib Area Under the Concentration Curve From 0-24 Hours (AUC)||Week 2 of course 1|PK Data was combined at each dose level accross strata (Stratum 1A, Stratum 1B, and Stratum 2); at Dose 250 mg/m^2 of Gefitinib accross strata, PK data from Phase-I patients was analysed earlier for the publication of the Phase-I trial. PK data for the Phase-II patients was analyzed separately for the Phase-II publication.||mcg/L*hr||Full Range|Median
700251|NCT00042991|Secondary|Time of Maximum Clearance of Gefitinib (Tmax)||Week 2 of course 1|PK Data was combined at each dose level accross strata (Stratum 1A, Stratum 1B, and Stratum 2); at Dose 250 mg/m^2 of Gefitinib accross strata, PK data from Phase-I patients was analysed earlier for the publication of the Phase-I trial. PK data for the Phase-II patients was analyzed separately for the Phase-II publication.||Hour||Full Range|Median
700252|NCT00042991|Secondary|Clearance of Gefitinib (Cl)||Week 2 of course 1|PK Data was combined at each dose level accross strata (Stratum 1A, Stratum 1B, and Stratum 2); at Dose 250 mg/m^2 of Gefitinib accross strata, PK data from Phase-I patients was analysed earlier for the publication of the Phase-I trial. PK data for the Phase-II patients was analyzed separately for the Phase-II publication.||L/hr/m2||Full Range|Median
700253|NCT00042991|Secondary|Elimination Half Life of Gefitinib (t1/2)||Week 2 of course 1|PK Data was combined at each dose level accross strata (Stratum 1A, Stratum 1B, and Stratum 2); at Dose 250 mg/m^2 of Gefitinib accross strata, PK data from Phase-I patients was analysed earlier for the publication of the Phase-I trial. PK data for the Phase-II patients was analyzed separately for the Phase-II publication.||hour||Full Range|Median
700254|NCT00042991|Secondary|Peak Serum Concentration of Gefitinib (Cmax)||Week 2 of course 1|PK Data was combined at each dose level accross strata (Stratum 1A, Stratum 1B, and Stratum 2); at Dose 250 mg/m^2 of Gefitinib accross strata, PK data from Phase-I patients was analysed earlier for the publication of the Phase-I trial. PK data for the Phase-II patients was analyzed separately for the Phase-II publication.||mcg/ml||Full Range|Median
700255|NCT00042991|Secondary|Mean Tumor to White Matter Ratio Measured at Baseline|This study attempts to characterize neuroimaging parameters from positron emission tomography. For each patient, the axial image through the tumor containing the maximum activity per pixel corresponding to the highest FluoroDeoxyGlucose (FDG) uptake was identified and a region of interest (ROI) was drawn based on the FDG definition of the tumor. The mean pixel values within the tumor ROI were normalized by those for normal white matter to provide ratios of tumor/gray matter. Each patient has a mean tumor to white matter ratio value and the median of these values across patients is reported.|Baseline|Out of 43 patients, only 18 Patients had baseline PET scans. Therefore, this analysis is based on these 18 patients.||Ratio||Full Range|Median
700256|NCT00042991|Secondary|Mean Tumor to Gray Matter Ratio Measured at Baseline|This study attempts to characterize neuroimaging parameters from positron emission tomography. For each patient, the axial image through the tumor containing the maximum activity per pixel corresponding to the highest FluoroDeoxyGlucose (FDG) uptake was identified and a region of interest (ROI) was drawn based on the FDG definition of the tumor. The mean pixel values within the tumor ROI were normalized by those for normal gray matter to provide ratios of tumor/gray matter. Each patient has a mean tumor to gray matter ratio value and the median of these values across patients is reported.|Baseline|Out of 43 patients, only 18 Patients had baseline PET scans. Therefore, this analysis is based on these 18 patients.||Ratio||Full Range|Median
700257|NCT00042991|Secondary|Change From Baseline in Perfusion Ratio at Two Weeks After Completion of Radiation|This study attempted to investigate in an exploratory manner the effect of treatment on changes in various neuroimaging variables. Neuroimaging changes may have some association with outcome (response,survival, etc.). Perfusion ratio is one parameter obtained from standard magnetic resonance imaging (MRI) studies of the brain.|Baseline and two weeks post completion of radiation|Out of 43 patients, 20 patients had perfusion scans before the treatment started and at the time of the completion of Radiation therapy. Therefore, this analysis is based on the volumetric data from these 20 patients.||Ratio||Full Range|Median
700258|NCT00042991|Secondary|Change From Baseline in Diffusion Ratio at Two Weeks After Completion of Radiation|This study attempted to investigate in an exploratory manner the effect of treatment on changes in various neuroimaging variables. Neuroimaging changes may have some association with outcome (response,survival, etc.). Diffusion ratio is one parameter obtained from standard magnetic resonance imaging (MRI) studies of the brain.|Baseline and two weeks post completion of radiation|Out of 43 patients, 29 patients had diffusion scans before the treatment started and at the time of the completion of Radiation therapy. Therefore, this analysis is based on the volumetric data from these 29 patients.||Ratio||Full Range|Median
700259|NCT00042991|Secondary|Change From Baseline in Volume Enhancing at Two Weeks After Completion of Radiation|This study attempted to investigate in an exploratory manner the effect of treatment on changes in various neuroimaging variables. Neuroimaging changes may have some association with outcome (response,survival, etc.). Volume enhancing is one parameter obtained from standard magnetic resonance imaging (MRI) studies of the brain.|Baseline and two weeks post completion of radiation|Out of 43 patients, for only 19 patients, enhacing tumor was greater than zero based on brain MRI scans before the treatment started and at the time of the completion of Radiation therapy. Therefore, this analysis is based on the enhancing volumetric data from these 19 patients.||cc||Full Range|Median
700260|NCT00042991|Secondary|Change in Tumor Volume Measured on Fluid Attenuated Inversion Recovery (FLAIR) Imaging at Before the Protocol Therapy Started and at Two Weeks After Completion of Radiation|This study attempted to investigate in an exploratory manner the effect of treatment on changes in various neuroimaging variables. In this particular objective, the study aimed to investigate how radiation+gefitinib affect the tumor volume. Tumor volume is measured using Fluid Attenuated Inversion Recovery (FLAIR) before and after the radiation therapy.|Baseline and two weeks post completion of radiation|Out of 43 patients, 35 patients had brain MRI before the treatment started and at the time of the completion of Radiation therapy. Therefore, this analysis is based on the volumetric data from these 35 patients.||cc||Full Range|Median
700261|NCT00042991|Primary|Median Survival in Newly Diagnosed Brain Stem Gliomas|Overall survival is defined as the interval from initiation of treatment to death or date of last contact for surviving patients|Assessed from the start of therapy until three years after initiation of gefitinib therapy|||Months||Full Range|Median
701331|NCT00056862|Secondary|Time to Negativity|Time from treatment initiation to the first negative HCV RNA test during treatment|24 weeks|||days||95% Confidence Interval|Median
700262|NCT00042991|Primary|Median Progression-free Survival in Newly Diagnosed Brain Stem Gliomas|Progression-free survival is defined as the interval from intiation of treatment to the earliest of disease progression (tumor increase of 25% over baseline tumor measurement; appearance of new lesion(s); or progressive/worsening neurlogical status) or death for patients who failed or to the last date of follow-up for patients without failure|Assessed pre-radiation, every 8 weeks for 13 courses of therapy, and then every 12 weeks|Here, we only report the results for Phase-II trial as this objective was specifically for the Phase-II trial. This cohort includes seven patients who were treated during Phase-I at Dose 250 mg/m^2 of Gefitinib.||Months||Full Range|Median
700263|NCT00042991|Primary|Number of Participants in Phase I Stratum 1A With Dose-limiting Toxicities (DLT) Observed During the First 8 Weeks of Gefitinib Therapy|The dose limiting toxicity (DLT) analysis population consists of stratum 1A phase I participants who developed DLT during the maximum tolerated dose (MTD) estimation period (course 1 and 2) or who completed the MTD estimation period without DLTs. DLTs observed during courses 1 and 2 were used to estimate the MTD based on the tradional 3+3 design, where a dose is considered a safe dose only when 0 out of 3, or at most 1 out of 6 patients has DLTs. When two or more patients in a group of 2 to 6 patients had DLTs, then that dose level was considered to be too toxic.|Day 1 of gefitinib therapy to end of week 8|This cohort includes only the patients who were enrolled and treated on Gefitinib+Radiation during the Phase I component of the trial, where the safety of Gefitinib was assedded at Dose Levels 100 mg/m^2, 250 mg/m^2, and 375 mg/m^2.||Participants|||Number
700264|NCT00043186|Secondary|Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 48|Bone specific alkaline phosphatase (BSAP). Percent change from Baseline to Month 48 calculated using ((Month 48 value - Baseline value) / Baseline value ) x 100.|Baseline and 48 months|Randomized participants with non-missing Baseline and non-missing value at Month 48.||Percent change||Inter-Quartile Range|Median
700265|NCT00043186|Secondary|Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 42|Bone specific alkaline phosphatase (BSAP). Percent change from Baseline to Month 42 calculated using ((Month 42 value - Baseline value) / Baseline value ) x 100.|Baseline and 42 months|Randomized participants with non-missing Baseline and non-missing value at Month 42.||Percent change||Inter-Quartile Range|Median
700266|NCT00043186|Secondary|Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 36|Bone specific alkaline phosphatase (BSAP). Percent change from Baseline to Month 36 calculated using ((Month 36 value - Baseline value) / Baseline value ) x 100.|Baseline and 36 months|Randomized participants with non-missing Baseline and non-missing value at Month 36.||Percent change||Inter-Quartile Range|Median
700267|NCT00043186|Secondary|Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 24|Bone specific alkaline phosphatase (BSAP). Percent change from Baseline to Month 24 calculated using ((Month 24 value - Baseline value) / Baseline value ) x 100.|Baseline and 24 months|Randomized participants with non-missing Baseline and non-missing value at Month 24.||Percent change||Inter-Quartile Range|Median
700268|NCT00043186|Secondary|Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 12|Bone specific alkaline phosphatase (BSAP). Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.|Baseline and 12 months|Randomized participants with non-missing Baseline and non-missing value at Month 12.||Percent change||Inter-Quartile Range|Median
700269|NCT00043186|Secondary|Total Body Bone Mineral Density Percent Change From Baseline at Month 48|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 48 calculated using ((Month 48 value - Baseline value) / Baseline value ) x 100.|Baseline and 48 months|Randomized participants with non-missing Baseline and non-missing value at Month 48.||Percent change||Standard Error|Least Squares Mean
700270|NCT00043186|Secondary|Total Body Bone Mineral Density Percent Change From Baseline at Month 42|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 42 calculated using ((Month 42 value - Baseline value) / Baseline value ) x 100.|Baseline and 42 months|Randomized participants with non-missing Baseline and non-missing value at Month 42.||Percent change||Standard Error|Least Squares Mean
700271|NCT00043186|Secondary|Total Body Bone Mineral Density Percent Change From Baseline at Month 36|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 36 calculated using ((Month 36 value - Baseline value) / Baseline value ) x 100.|Baseline and 36 months|Randomized participants with non-missing Baseline and non-missing value at Month 36.||Percent change||Standard Error|Least Squares Mean
700272|NCT00043186|Secondary|Total Body Bone Mineral Density Percent Change From Baseline at Month 24|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 24 calculated using ((Month 24 value - Baseline value) / Baseline value ) x 100.|Baseline and 24 months|Randomized participants with non-missing Baseline and non-missing value at Month 24.||Percent change||Standard Error|Least Squares Mean
700273|NCT00043186|Secondary|Total Body Bone Mineral Density Percent Change From Baseline at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.|Baseline and 12 months|Randomized participants with non-missing Baseline and non-missing value at Month 12.||Percent change||Standard Error|Least Squares Mean
700274|NCT00043186|Secondary|Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 48|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 48 calculated using ((Month 48 value - Baseline value) / Baseline value ) x 100.|Baseline and 48 months|Randomized participants with non-missing baseline and non-missing value at Month 48.||Percent change||Standard Error|Least Squares Mean
700275|NCT00043186|Secondary|Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 42|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 42 calculated using ((Month 42 value - Baseline value) / Baseline value ) x 100.|Baseline and 42 months|Randomized participants with non-missing Baseline and non-missing value at Month 42.||Percent change||Standard Error|Least Squares Mean
700276|NCT00043186|Secondary|Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 36|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 36 calculated using ((Month 36 value - Baseline value) / Baseline value ) x 100.|Baseline and 36 months|Randomized participants with non-missing Baseline and non-missing value at Month 36.||Percent change||Standard Error|Least Squares Mean
700278|NCT00043186|Secondary|Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.|Baseline and 12 months|Randomized participants with non-missing Baseline and non-missing value at Month 12.||Percent change||Standard Error|Least Squares Mean
700279|NCT00043186|Secondary|Total Hip Bone Mineral Density Percent Change From Baseline at Month 48|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 48 calculated using ((Month 48 value - Baseline value) / Baseline value ) x 100.|Baseline and 48 months|Randomized participants with non-missing Baseline and non-missing value at Month 48.||Percent change||Standard Error|Least Squares Mean
700280|NCT00043186|Secondary|Total Hip Bone Mineral Density Percent Change From Baseline at Month 42|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 42 calculated using ((Month 42 value - Baseline value) / Baseline value ) x 100.|Baseline and 42 months|Randomized participants with non-missing Baseline and non-missing value at Month 42.||Percent change||Standard Error|Least Squares Mean
700281|NCT00043186|Secondary|Total Hip Bone Mineral Density Percent Change From Baseline at Month 36|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 36 calculated using ((Month 36 value - Baseline value) / Baseline value ) x 100.|Baseline and 36 months|Randomized participants with non-missing Baseline and non-missing value at Month 36.||Percent change||Standard Error|Least Squares Mean
700282|NCT00043186|Secondary|Total Hip Bone Mineral Density Percent Change From Baseline at Month 24|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 24 calculated using ((Month 24 value - Baseline value) / Baseline value ) x 100.|Baseline and 24 months|Randomized participants with non-missing Baseline and non-missing value at Month 24.||Percent change||Standard Error|Least Squares Mean
700283|NCT00043186|Secondary|Total Hip Bone Mineral Density Percent Change From Baseline at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.|Baseline and 12 months|Randomized participants with non-missing Baseline and non-missing value at Month 12.||Percent change||Standard Error|Least Squares Mean
700284|NCT00043186|Secondary|Urine NTX/Creatinine Percent Change From Baseline at Month 48|Urinary N-telopeptide (uNTX)/Creatinine. Percent change from Baseline to Month 48 calculated using ((Month 48 value - Baseline value) / Baseline value ) x 100.|Baseline and 48 months|Randomized participants with non-missing Baseline and non-missing value at Month 48.||Percent change||Inter-Quartile Range|Median
700285|NCT00043186|Secondary|Urine NTX/Creatinine Percent Change From Baseline at Month 42|Urinary N-telopeptide (uNTX)/Creatinine. Percent change from Baseline to Month 42 calculated using ((Month 42 value - Baseline value) / Baseline value ) x 100.|Baseline and 42 months|Randomized participants with non-missing Baseline and non-missing value at Month 42.||Percent change||Inter-Quartile Range|Median
700286|NCT00043186|Secondary|Urine NTX/Creatinine Percent Change From Baseline at Month 36|Urinary N-telopeptide (uNTX)/Creatinine. Percent change from Baseline to Month 36 calculated using ((Month 36 value - Baseline value) / Baseline value ) x 100.|Baseline and 36 months|Randomized participants with non-missing Baseline and non-missing value at Month 36.||Percent change||Inter-Quartile Range|Median
700287|NCT00043186|Secondary|Urine NTX/Creatinine Percent Change From Baseline at Month 24|Urinary N-telopeptide (uNTX)/Creatinine. Percent change from Baseline to Month 24 calculated using ((Month 24 value - Baseline value) / Baseline value ) x 100.|Baseline and 24 months|Randomized participants with non-missing Baseline and non-missing value at Month 24.||Percent change||Inter-Quartile Range|Median
700288|NCT00043186|Secondary|Serum CTX Percent Change From Baseline at Month 48|Serum C-Telopeptide (CTX). Percent change from Baseline to Month 48 calculated using ((Month 48 value - Baseline value) / Baseline value ) x 100.|Baseline and 48 months|Randomized participants with non-missing Baseline and non-missing value at Month 48.||Percent change||Inter-Quartile Range|Median
700289|NCT00043186|Secondary|Serum CTX Percent Change From Baseline at Month 42|Serum C-Telopeptide (CTX). Percent change from Baseline to Month 42 calculated using ((Month 42 value - Baseline value) / Baseline value ) x 100.|Baseline and 42 months|Randomized participantswith non-missing Baseline and non-missing value at Month 42.||Percent change||Inter-Quartile Range|Median
700290|NCT00043186|Secondary|Serum CTX Percent Change From Baseline at Month 36|Serum C-Telopeptide (CTX). Percent change from Baseline to Month 36 calculated using ((Month 36 value - Baseline value) / Baseline value ) x 100.|Baseline and 36 months|Randomized participants with non-missing Baseline and non-missing value at Month 36.||Percent change||Inter-Quartile Range|Median
700291|NCT00043186|Secondary|Serum CTX Percent Change From Baseline at Month 24|Serum C-Telopeptide (CTX). Percent change from Baseline to Month 24 calculated using ((Month 24 value - Baseline value) / Baseline value ) x 100.|Baseline and 24 months|Randomized participants with non-missing Baseline and non-missing value at Month 24.||Percent change||Inter-Quartile Range|Median
700292|NCT00043186|Secondary|Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 48|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 48 calculated using ((Month 48 value - Baseline value) / Baseline value ) x 100.|Baseline and 48 months|Randomized participants with non-missing Baseline and non-missing value at Month 48.||Percent change||Standard Error|Least Squares Mean
700293|NCT00043186|Secondary|Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 42|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 42 calculated using ((Month 42 value - Baseline value) / Baseline value ) x 100.|Baseline and 42 months|Randomized participants with non-missing Baseline and non-missing value at Month 42.||Percent change||Standard Error|Least Squares Mean
700294|NCT00043186|Secondary|Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 36|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 36 calculated using ((Month 36 value - Baseline value) / Baseline value ) x 100.|Baseline and 36 months|Randomized participants with non-missing Baseline and non-missing value at Month 36.||Percent change||Standard Error|Least Squares Mean
701332|NCT00056862|Secondary|Slope of Second Phase Decline in HCV Levels|The 2nd phase slope is defined as the slope of the logarithmic viral levels from week 1 to week 4 of treatment (see Neumann et al, Science, 1998).|day 7 to day 28|||logIU/mL||Standard Deviation|Mean
700295|NCT00043186|Secondary|Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 24 calculated using ((Month 24 value - Baseline value) / Baseline value ) x 100.|Baseline and 24 months|Randomized participants with non-missing Baseline and non-missing value at Month 24.||Percent change||Standard Error|Least Squares Mean
700296|NCT00043186|Secondary|Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12 for the Alendronate Arm|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.|Baseline and Month 12|Randomized participants with non-missing Baseline and non-missing value at Month 12.||Percent change||Standard Error|Least Squares Mean
700297|NCT00043186|Secondary|Urine NTX/Creatinine Percent Change From Baseline at Month 12|Urinary N-telopeptide (uNTX)/Creatinine. Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.|Baseline and Month 12|Randomized participants with non-missing Baseline and non-missing value at Month 12.||Percent change||Inter-Quartile Range|Median
700298|NCT00043186|Secondary|Serum CTX Percent Change From Baseline at Month 12|Serum C-Telopeptide (CTX). Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.|Baseline and Month 12|Randomized participants with non-missing Baseline and non-missing value at Month 12||Percent change||Inter-Quartile Range|Median
700299|NCT00043186|Primary|Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12 for the Placebo and Denosumab Arms|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.|Baseline and Month 12|Randomized participants with non-missing Baseline and non-missing value at Month 12.||Percent change||Standard Error|Least Squares Mean
700300|NCT00046930|Secondary|Response|Number of eligible participants in each response category. Categories, based on peripheral blood counts and bone marrow aspirate and biopsy, include complete remission (CR), partial remission (PR), morphologic complete remission (MCR), and relapse.|Assessed at the end of induction|||Participants|||Number
700301|NCT00046930|Secondary|Progression-free Survival (PFS)|Time from randomization to the earlier of disease progression or death. Patients alive and progression-free at last follow-up were censored.|Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually thereafter|Eligible participants, as randomized. Patients who had neither documented progression nor death within 3 months of registration without disease evaluation were excluded.||Months||95% Confidence Interval|Median
700302|NCT00046930|Primary|Overall Survival (OS)|Time from randomization to death. Patients alive at last follow-up were censored.|Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually thereafter|Eligible participants, as randomized||Months||95% Confidence Interval|Median
700303|NCT00047008|Secondary|Correlation of COX-2 With Outcomes||From randomization to date of death or last follow-up||||||
700304|NCT00047008|Secondary|Correlation of Epidermal Growth Factor Receptor(EGFR) With Outcomes||From randomization to date of death or last follow-up||||||
700305|NCT00047008|Secondary|Quality of Life||From randomization to 5 years||||||
700306|NCT00047008|Secondary|Rate of Grade 3-5 Toxicity||From start of treatment to last follow-up||||||
700307|NCT00047008|Secondary|Disease-free Survival|From randomization to date of failure (local or regional persistence/relapse, distant metastasis, secondary primary tumor or death) or last follow-up. Analysis occurs after 309 deaths have been reported.|From randomization to date of failure||||||
700308|NCT00047008|Secondary|Local-regional Control|From randomization to date of failure (local or regional persistence/relapse) or death or last follow-up. Analysis occurs after 309 deaths have been reported.|From randomization to date of failure||||||
700309|NCT00047008|Primary|Overall Survival (3-year Rate)|Time from randomization to death due to any cause or last known date alive. Median survival was not reached, therefore 3-year survival rates are reported.|From randomization to date of death or last follow-up. Analysis occurs after 309 deaths have been reported.|Eligible patients who did not withdraw consent.||percentage of patients||95% Confidence Interval|Number
700310|NCT00047320|Secondary|Occurrence of Nonhematological Grade 4 Toxicity||18 weeks||||||
700311|NCT00047320|Secondary|Toxic Death|Defined as death predominantly attributable to treatment-related causes.|18 weeks||||||
700312|NCT00047320|Secondary|Overall Survival||Time from study entry to death from any cause||||||
700313|NCT00047320|Secondary|Progression-free Survival||Time from study entry to disease progression or recurrence. Deaths that are clearly unrelated to disease progression, and second neoplasms, are censored in this analysis.||||||
700314|NCT00047320|Secondary|Event-free Survival||From time from study entry to death from any cause, disease progression or recurrence, or second malignant neoplasm.||||||
700315|NCT00047320|Primary|Response to Induction Chemotherapy|A patient who achieves a complete or partial response, defined a reduction of at least 65% in tumor size without complete disappearance of tumor after induction chemotherapy will be considered to have experienced response.|18 weeks|Of the 101 eligible patients, 85 completed induction chemotherapy with sufficient data to assess response. Central review response assessment is used.||participants|||Number
700316|NCT00047385|Secondary|T2 Screening Results|Results of radiologist's interpretation of images from LDCT or CXR screening exam at T2. Includes a comparison with images from T0 and T1 screens.|T2 (two years after entry)|All participants randomized were analyzed||Participants|||Number
700317|NCT00047385|Secondary|T1 Screening Results|Results of radiologist's interpretation of images from LDCT or CXR screening exam at T1. Includes a comparison with images from T0 screen.|T1 (one year after entry)|All participants randomized were analyzed||Participants|||Number
700318|NCT00047385|Secondary|T0 (Baseline) Screening Results|Results of radiologist's interpretation of images from LDCT or CXR screening exam at T0.|T0 (at study entry)|All participants randomized were analyzed.||Participants|||Number
700345|NCT00048061|Secondary|Percentage of Participants With Mean Trochanter and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24|A participant is a responder if the mean trochanter and lumbar spine BMD had remained the same or increased above baseline.|Months 12 and 24|The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.||Percentage of participants|||Number
700319|NCT00047385|Secondary|Complications of Diagnostic Evaluation Following a Positive Screening Test.|Number of participants who experienced complications during diagnostic work-up of a screening CT or CXR that was suspicious for lung cancer.|One year from screening examination|The units analyzed were positive screening exams with documented diagnostic follow-up. If participant received 3 positive screens with documented follow-up after each one, he/she would be counted 3 times in the number of units analyzed.||Pos. screens w/ complications|Participants||Number
700320|NCT00047385|Secondary|Lung Cancer Diagnoses|Lung cancer diagnoses confirmed by medical record abstraction.|All events through December 31, 2009; median follow-up 6.5 years|All participants randomized were analyzed. An intention-to-treat analysis was performed.||Participants|||Number
700321|NCT00047385|Secondary|Deaths From All Causes in All Randomized Participants.|Deaths from all causes were compared between the low-dose CT group and the chest radiography group among all randomized participants.|All events through December 31, 2009; median follow-up 6.5 years.|All participants randomized were analyzed. An intention-to-treat analysis was performed.||Participants|||Number
700322|NCT00047385|Primary|Lung Cancer Deaths|Lung cancer deaths confirmed in participants by Endpoint Verification if available, otherwise by death certificate.|All events through December 31, 2009; median follow-up 6.5 years.|All participants randomized were analyzed. An intention-to-treat analysis was performed.||Participants|||Number
700323|NCT00047463|Secondary|Number of Patients Requiring Only One Night of Baseline Sleep Study to Detect Sleep Apnea|The data presented below represent the number of participants who required only one night of baseline sleep study prior to randomization|prior to randomization|These are participants that were enrolled and assessed to determine if one night of baseline sleep study was sufficient to detect sleep apnea. This occurred prior to randomization. Five of the assessed participants were not randomized.||Participants|||Number
700324|NCT00047463|Secondary|Number of Patients That Were Able to be Blinded to CPAP or Placebo CPAP|Patients all received a CPAP machine which either delivered CPAP or provided the patient with placebo CPAP, which had the same sensation as receiving CPAP|10 weeks|||participants|||Number
700325|NCT00047463|Primary|CPAP Adherence/Tolerance as Measured by Proportion of Nights Used|This measure quantifies how well patients use their CPAP. The standard unit of measurement is proportion of nights that the CPAP is used by a participant (total nights used/total nights the device could have been used), averaged across all participants . Data were downloaded by a card placed in the CPAP machine reflecting use over the entire 10 weeks.|10 weeks|||proportion of nights used (total nights||Standard Deviation|Mean
700326|NCT00047619|Primary|Pressure Ulcer Volume Measurement|Volume of pressure ulcer was measured by the amount of fluid that could be used to fill the pressure ulcer which was covered by an occlusive dressing|study participation - up to 6 weeks|||cm^3||95% Confidence Interval|Mean
700327|NCT00047619|Primary|Pressure Ulcer Geometry|Linear assessment of wounds|study participation - up to 6 weeks|||cm||95% Confidence Interval|Mean
700328|NCT00047697|Primary|Cognitive Assessment: CVLT|California Verbal Learning Test (percent of correct answers) Range: 0-100. Higher = better|8 weeks|||percentage of correct answers||Standard Deviation|Mean
700329|NCT00047697|Primary|Cognitive Assessment: EOWVT Standard Score|Expressive One Word Vocabulary Test (standard score) Range: 55-140. Higher = better|8 weeks|||units on a scale||Standard Deviation|Mean
700330|NCT00047697|Primary|Cognitive Assessment: TMT|TMT: Trial-Making Test. Time (sec) Range: 0 - 300. Lower = better|8 weeks|||seconds||Standard Deviation|Mean
700331|NCT00047879|Secondary|The Number of Participants With Adverse Events|Here are the total number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|4 months|||Participants|||Number
700332|NCT00047879|Secondary|Number of Participants With Complete or Partial Response|"Response is defined per RECIST criteria. Measurable disease is defined as bidimensionally measurable lesions with clearly defined margins by CT or MRI scan.
Evaluable disease is defined as unidimensionally measurable lesions, masses with margins not clearly defined, or lesions with a multiple cystic component.
Complete response (CR) is complete disappearance of all measurable and evaluable disease. Partial response (PR) is greater than or equal to 50% decrease under baseline in the sum of products or perpendicular diameters of all measurable lesions."|6 months|Registered 7 out of 64 participants and they came off study for progressive disease around 3-4 months after starting the study.||Participants|||Number
700333|NCT00047879|Primary|Progression-free Survival|"Progression free survival is defined as the percent of patients that are progression free and alive 6 months after initiating therapy.
Progression of disease by > 50% increase in the size of the tumor compared to baseline after the first cycle only, and then >25% increase in the size of the tumor for all subsequent cycles."|6 months|The primary objective was not met. Only registered 7 out of 64 participants and they all came off the study for progressive disease around 3-4 months after starting the study. None of the participants were evaluated for progression-free survival at 6 months because the study was stopped at 4 months due to progressive disease.||Percent of participants|||Number
700334|NCT00048035|Secondary|Mean Change in Pulse Rate|Participants pulse rates in beats per minute (BpM) were analyzed at sitting position using descriptive statistical methods (ie, means, standard deviations and percentiles). The changes in pulse rate throughout the study were analysed at each study visit and mean change is reported.|Up to Week 126|The safety population was considered for analysis which included all participants who received at least one dose of study drug||BpM||Standard Deviation|Mean
700335|NCT00048035|Secondary|Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Before and After Dialysis|Mean Change from Baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) is calculated as the end of treatment values minus the Baseline value. Baseline (Day -28 to Day 1) values were calculated as the mean of the screening assessment (SA) and run-in period (Week -2 and Week –1).|From Baseline (Day -28 to Day 1) to Week 126|The safety population was considered for analysis which included all participants who received at least one dose of study drug.||mm HG||Standard Deviation|Mean
700346|NCT00048061|Secondary|Percentage of Participants With Mean Total Hip and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24|A participant is a responder if the mean total hip and mean lumbar spine BMD had remained the same or increased above baseline.|Months 12 and 24|The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.||Percentage of participants|||Number
700336|NCT00048035|Secondary|Number of Participants With Marked Laboratory Abnormalities|Marked abnormality was defined as above and/or below a value which was considered to be potentially clinically relevant. The number of participants with marked lab abnormality across treatment groups were reported and presented. Marked laboratory abnormalities were analyzed according to the Roche specified limits for the following reference range: White blood cells (WBC) (3.0– 18.0 10^9/L), Platelets (100 – 550 10^9/L), Alanine aminotransferase (ALAT) [0 110 units per litre (U/L)], Alkaline Phosphatase (ALP) (0 – 220 U/L), Aspartate aminotransferase (ASAT) (0 – 80 U/L), Albumin >= 30 g/L, Phosphate [0.75 - 1.60 millimoles per liter (mmol/L)], Potassium (2.9 – 5.8 mmol/L), Glucose (2.80 – 11.10 mmol/L).|Up to Week 126|The safety population was considered for analysis which included all participants who received at least one dose of study drug.||Participants|||Number
700337|NCT00048035|Secondary|Number of Participants With Any Adverse Events, Any Serious Adverse Events, And Deaths|An Adverse Events (AEs) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Serious Adverse Events (SAEs) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator’s judgment or requires intervention to prevent one or other of these outcomes. ). The study design tested 3 different starting dose conversion factors at 3 different dosing schedules during the core study period. As study drug doses can be modified continually over time all results for the two long term safety periods were displayed by dose schedule group only.|Up to Week 126|The safety population was considered for analysis which included all participants who received at least one dose of study drug.||Participants|||Number
700338|NCT00048035|Secondary|Median Change From Baseline in Hematocrit Levels to End of Initial Treatment Under Constant Dosing Regimen|Median change from Baseline in hematocrit (Hct) levels to end of initial treatment under constant dosing regimen was reported. Baseline (Day -28 to Day 1) Hct values was calculated as the mean of the SA and run-in period (Weeks -2 and -1). For all participants, an EOIT value was calculated as the last observed Hct value before a dose change or blood transfusion. For participants without any dose adjustments or blood transfusion, the EOIT value was identical to the Week 19 value.|From Baseline (Day -28 to Day 1) to EOIT (Week 19)|The Intent-to-Treat (ITT) population was defined as all randomized participants.||g/dL||Inter-Quartile Range|Median
700339|NCT00048035|Primary|Median Change From Baseline in Hemoglobin Levels to End of Initial Treatment Under Constant Dosing Regimen|Median change from Baseline in hemoglobin (Hb) levels to end of initial treatment (EOIT) under constant dosing regimen was reported. For ease of interpretation, all individual slope values were multiplied by 42 to give an estimate of change in Hb values over six weeks. Baseline (Day -28 to Day 1) Hb values was calculated as the mean of the screening assessment (SA) and run-in period (Week -2 and Week –1). For all participants, an EOIT value was calculated as the last observed Hb value before a dose change or blood transfusion. For participants without any dose adjustments or blood transfusion, the EOIT value was identical to the Week 19 value.|From Baseline (Day -28 to Day 1) to EOIT (Week 19)|The Intent-to-Treat (ITT) population was defined as all randomized participants.||g/dL||Inter-Quartile Range|Median
700340|NCT00048061|Secondary|Number Of Participants With Marked Laboratory Abnormalities|Marked laboratory abnormalities were defined as those values that were outside the reference range and showed a clinically relevant change from baseline. The reference range for hemoglobin was 110-200 (gram per liter [g/L]), hematocrit was 0.31-0.56 fraction, white blood cells (WBC) was 3.0-18.0 (10*9/L), serum glutamic-pyruvic transaminase (SGPT/ALT) was 0-110 IU/L, blood urea nitrogen (BUN) was 0.0-14.3 (millimoles per Liter [mmol/L]), Chloride was 95-115 (mmol/L), Potassium was 3.0 – 6.0 (mmol/L), Sodium was 130-150 (mmol/L), Calcium was 2.00-2.90 (mmol/L), Phosphate was 0.75 – 1.60 (mmol/L) and Creatinine was 0- 154 (micromoles/liter [umol/L].|Up to Month 24|The safety population consisted of all participants who were randomized and received at least one dose of the study medication, and who have at least one follow-up data point. n = number of participants evaluable at particular time of assessment.||Participants|||Number
700341|NCT00048061|Secondary|Number of Participants With Any Adverse Events and Serious Adverse Event|An Adverse Event (AE) is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.|Up to Month 24|The safety population consisted of all participants who were randomized and received at least one dose of the study medication, and who have at least one follow-up data point.||Participants|||Number
700342|NCT00048061|Secondary|Absolute Change In Baseline in Serum CTX to Months 12 and 24|Serum CTX, a biochemical marker of bone resorption, was assessed using the Elecsys S-CTX-I assay (an ElectroChemiLuminescence Immunoassay (ECLIA) Technique).|From Baseline (Month 0) to Months 12 and 24|The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.||ng/ml||Standard Deviation|Mean
700343|NCT00048061|Secondary|Relative Change In Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen [ CTX] ] to Months 3, 6, 12, and 24|Serum CTX, a biochemical marker of bone resorption, was assessed using the Elecsys S-CTX-I assay (an ElectroChemiLuminescence Immunoassay (ECLIA) Technique).|From Baseline (Month 0) to Months 3, 6, 12, 24|The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.||Percent change||Standard Deviation|Mean
700344|NCT00048061|Secondary|Percentage of Participants With Mean Femoral Neck and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24|A participant is a responder if the mean femoral neck and lumbar spine BMD had remained the same or increased above baseline.|Months 12 and 24|The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.||Percentage of participants|||Number
700347|NCT00048061|Secondary|Percentage of Participants With Femoral Neck BMD Above or Equal to Baseline at Months 12 and 24|A participant is a responder if the mean femoral neck BMD had remained the same or increased above baseline.|Months 12 and 24|The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.||Percentage of participants|||Number
700348|NCT00048061|Secondary|Percentage of Participants With Trochanter BMD Above or Equal to Baseline at Months 12 and 24|A participant is a responder if the mean trochanter BMD had remained the same or increased above baseline.|Months 12 and 24|The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.||Percentage of participants|||Number
700349|NCT00048061|Secondary|Percentage of Participants With Total Hip BMD Above or Equal to Baseline at Months 12 and 24|A participant is a responder if the mean total hip BMD had remained the same or increased above baseline.|Months 12 and 24|The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.||Percentage of participants|||Number
700350|NCT00048061|Secondary|Percentage of Participants With Mean Lumbar Spine (L2 - L4) BMD Above or Equal to Baseline at Months 12 and 24|A participant is a responder if the mean lumber spine (L2 – L4) BMD had remained the same or increased above baseline.|Months 12 and 24|The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.||Percentage of participants|||Number
700351|NCT00048061|Secondary|Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD.|Proximal femur BMD was measured by dual-energy X-ray absorptiometry at baseline, after one and two years of treatment and was read by a central reading center|From Baseline (Month 0) to Months 12 and 24|The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.||g/cm2||Standard Deviation|Mean
700352|NCT00048061|Secondary|Relative Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD|Proximal femur BMD was measured by dual-energy X ray absorptiometry at baseline, after one and two years of treatment and was read by a central reading center.|From Baseline (Month 0) to Months 12 and 24|The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.||Percent change||Standard Deviation|Mean
700353|NCT00048061|Secondary|Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD|The absolute change (g/cm^2) from baseline in mean BMD of the lumbar spine (L2 – L4) at one and two years. A difference in the mean values between the active groups and the control was calculated.|From Baseline (Month 0) to Months 12 and 24|The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.||g/cm2||Standard Deviation|Mean
700354|NCT00048061|Secondary|Relative Change From Baseline at Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD|Relative change in BMD is the percentage change from baseline of BMD of vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center after 24 months of treatment. It is calculated as the sum of bone mineral content divided by the sum of area of all lumbar vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process at Month 24.|From Baseline (Month 0) to Month 24|The PP population consisted of all participants in the ITT population who had no major violations of the protocol.Participants available at particular time point for assessment were included in the analysis.||Percent change||Standard Deviation|Mean
700355|NCT00048061|Primary|Relative Change From Baseline at One Year (12 Months) in Mean Lumbar Spine (L2 – L4) Bone Mineral Density|Relative change in Bone Mineral Density (BMD) is the percentage change from baseline of BMD of vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center after 12 months of treatment. It is calculated as the sum of bone mineral content divided by the sum of area of all lumbar vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process at Month 12. Participants available at particular time point for assessment were included in the analysis.|From Baseline (Month 0) to Month 12|The per-protocol(PP) population included participants in Intent-to-treat(ITT) population who were randomized, received at least one dose of medication and had at least one valid efficacy(BMD or Serum CTX)follow-up data point;defined as any measurement that can be scientifically compared to baseline measurement, and had no major protocol violations.||Percent change||Standard Deviation|Mean
700356|NCT00048074|Secondary|Number of Participants With Any Marked Abnormality in Laboratory Parameters|Marked laboratory test value abnormalities (high and low) are those which exceed the marked reference range (i.e., a reference range greater than the standard reference range) and which also represents a clinically relevant change from baseline of at least a designated amount. The indicated abnormal laboratory parameters (along with their marked reference range) are as follows: low and high Hematocrit (0.36 - 0.60 fraction), low and high hemoglobin (11.0 - 20.0 g/dL), low and high platelets (100 – 700 * 10^9/L), low and high white blood cell (WBC) (3.0 - 18.0 * 10^9/L), high alanine aminotransferase (ALAT) (0 – 60 U/L), high blood urea nitrogen (BUN) (0 - 14.3 mmol/L) , high creatinine (0 – 154 mmol/L), low albumin (27.0 - 48.0 g/L), low and high chloride (95 – 115 mmol/L), low potassium (3.0 - 6.0 mmol/L), low sodium (130 – 150 mmol/L), high calcium (2.00 - 2.90 mmol/L), low and high phosphate (0.75 - 1.60 mmol/L).|Approximately 2 years|Safety Population: All participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point. Only participants with data available for the indicated laboratory abnormality were analyzed.||participants|||Number
700451|NCT00048568|Primary|Mean BL Select Laboratory Parameters in the OL Period|Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185.|BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185|All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.||mg/dL||Standard Deviation|Mean
700357|NCT00048074|Secondary|Number of Participants Who Experienced Any Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.|Approximately 2 years|Safety Population: All participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.||participants|||Number
700358|NCT00048074|Secondary|Percentage of Participants With Mean Femoral Neck and Lumbar Spine BMD Above or Equal to Baseline at Month 12 and 24|A participant is a responder if the mean femoral neck and lumbar spine BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed.|At Month 12 and 24|Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol.||Percentage of participants|||Number
700359|NCT00048074|Secondary|Percentage of Participants With Mean Trochanter and Lumbar Spine BMD Above or Equal to Baseline at Month 12 and 24|A participant is a responder if the mean trochanter and lumbar spine BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed.|At Month 12 and 24|Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol.||Percentage of participants|||Number
700360|NCT00048074|Secondary|Percentage of Participants With Mean Total Hip and Lumbar Spine BMD Above or Equal to Baseline at Month 12 and 24|A participant is a responder if the mean total hip and mean lumbar spine BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed.|At Month 12 and 24|Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol.||Percentage of participants|||Number
700361|NCT00048074|Secondary|Percentage of Participants With Femoral Neck BMD Above or Equal to Baseline at Month 12 and 24|A participant is a responder if the mean femoral neck BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed.|At Month 12 and 24|Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol.||Percentage of participants|||Number
700362|NCT00048074|Secondary|Percentage of Participants With Trochanter BMD Above or Equal to Baseline at Month 12 and 24|A participant is a responder if the mean trochanter BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed.|At Month 12 and 24|Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol.||Percentage of participants|||Number
700363|NCT00048074|Secondary|Percentage of Participants With Total Hip BMD Above or Equal to Baseline at Month 12 and 24|A participant is a responder if the mean total hip BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed.|At Month 12 and 24|Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol.||Percentage of participants|||Number
700364|NCT00048074|Secondary|Percentage of Participants With Mean Lumbar Spine (L2 – L4) BMD Above or Equal to Baseline at Month 12 and 24|A participant is a responder if the mean lumber spine (L2 – L4) BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed.|At Month 12 and 24|Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol.||Percentage of participants|||Number
700365|NCT00048074|Secondary|Absolute Change From Baseline in Serum CTX at Month 6, 12, and 24|Serum CTX, a biochemical marker of bone resorption, was measured using the Elecsys s-CTX-I assay, an electrochemiluminescence immunoassay (ECLIA) technique. Samples for serum CTX measurements were collected from participants immediately prior to their IV dosing. Thus, the values reported here represent trough or residual values taken at the end of the 2 month or 3 month IV dosing interval. The absolute change from Baseline in serum CTX was defined as the difference between the last individual measurement available at Month 6 or Month 12 or Month 24 and Baseline. Only participants with data available at particular timepoint were analyzed.|Baseline, At Month 6, 12, and 24.|Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol.||Absolute Change (ng/mL)||Standard Deviation|Mean
700366|NCT00048074|Secondary|Relative Change From Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen (CTX) at Month 6, 12, and 24|Serum CTX, a biochemical marker of bone resorption, was measured using the Elecsys s-CTX-I assay, an electrochemiluminescence immunoassay (ECLIA) technique. Samples for serum CTX measurements were collected from participants immediately prior to their IV dosing. Thus, the values reported here represent trough or residual values taken at the end of the 2 month or 3 month IV dosing interval. The change in serum CTX was defined as the relative difference between the last individual measurement available at Month 6 or Month 12 or Month 24 and Baseline, using the following formula: Relative change = 100 x (CTX at Month 6/Month 12/Month 24- CTX at Baseline) / (CTX at Baseline). Only participants with data available at particular timepoint were analyzed.|Baseline, At Month 6, 12, and 24.|Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol.||Percent Change||Standard Deviation|Mean
700367|NCT00048074|Secondary|Absolute Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24|BMD was measured by a single DXA scan of the proximal femur at the time of screening, Month 12 and Month 24. The absolute change in BMD was defined as the difference between the last individual measurement available at Month 12 or Month 24 and Baseline. BMD of fractured bones that could impact the scan area were not taken into account. Only participants with data available at particular timepoint were analyzed.|Baseline, Month 12 and Month 24|Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol.||Absolute Change (g/cm^2)||Standard Deviation|Mean
700368|NCT00048074|Secondary|Relative Percent Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24|BMD was measured by a single DXA scan of the proximal femur at the time of screening, Month 12 and Month 24.The change in BMD of the proximal femur (total hip, trochanter, femoral neck) was defined as the relative difference between the last individual measurement available at Month 12 or Month 24and Baseline, using the following formula: Relative change = 100 x (BMD at 1 year/2year - BMD at Baseline) / (BMD at Baseline). BMD of fractured bones that could impact the scan area were not taken into account. Only participants with data available at particular timepoint were analyzed.|Baseline, Month 12 and Month 24|Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol.||Percent Change||Standard Deviation|Mean
700369|NCT00048074|Secondary|Absolute Change From Baseline in Mean BMD of Lumbar Spine (L2 – L4) at Month 12 and Month 24|BMD was measured by a single dual-energy x-ray absorptiometry (DXA) scan of the lumbar spine at screening, Month 12 and Month 24. The absolute change from Baseline in mean BMD of the lumbar spine (L2-L4) was defined as the difference between the last individual measurement available at Month 12 or Month 24 and Baseline. Only participants with data available at particular timepoint were analyzed.|Baseline, Month 12 and Month 24|Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol.||Absolute Change (g/cm^2)||Standard Deviation|Mean
700370|NCT00048074|Secondary|Relative Percent Change From Baseline in Mean BMD of Lumbar Spine (L2-L4) at 24 Months|BMD was measured by a single dual-energy x-ray absorptiometry (DXA) scan of the lumbar spine at the time of screening and at Month 24. The change in BMD was defined as the relative difference between the last individual measurement available at 24 months and Baseline, using the following formula: Relative change = 100 x (BMD at 1 year - BMD at Baseline) / (BMD at Baseline)|Baseline and Month 24|Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol.||Percent Change||Standard Deviation|Mean
700371|NCT00048074|Primary|Relative Percent Change From Baseline in Mean Bone Mineral Density (BMD) of Lumbar Spine (L2-L4) at 12 Months|BMD was measured by a single dual-energy x-ray absorptiometry (DXA) scan of the lumbar spine at the time of screening and at Month 12. The change in BMD was defined as the relative difference between the last individual measurement available at 12 months and Baseline, using the following formula: Relative change = 100 x (BMD at 1 year - BMD at Baseline) / (BMD at Baseline)|Baseline and Month 12|Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol.||Percent Change||Standard Deviation|Mean
700372|NCT00048165|Secondary|Number of Participants With Malignancies and Opportunistic Infections|The opportunistic infections included infections with Cytomegalovirus, Aspergillus, Candida, Pneumocystis, Cryptococcus, Listeria, Herpes simplex, Herpes zoster. For malignancy, participants with any type of malignancy whose date of onset or diagnosis was after randomization was reported.|Up to 12 months|Safety population included all participants who received at least one dose of study drug (daclizumab or placebo) or commercially available daclizumab and have at least one post-baseline safety assessment (eg. any laboratory data, adverse event, etc).||participants|||Number
700373|NCT00048165|Secondary|Number of Participants With Any Adverse Events and Any Serious Adverse Event, and Adverse Events Leading to Premature Withdrawal|An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Pre-existing conditions which worsened during this study were reported as AEs. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.|Up to 12 months|Safety population included all participants who received at least one dose of study drug (daclizumab or placebo) or commercially available daclizumab and have at least one post-baseline safety assessment (eg. any laboratory data, adverse event, etc).||participants|||Number
700374|NCT00048165|Secondary|Number of Participants With Marked Laboratory Abnormalities: Biochemistry Parameters|A marked reference range was predefined by Roche. The marked reference range is broader than the standard reference range. Values falling outside the marked reference range (low or high) that also represent a defined change from Baseline were considered marked laboratory abnormalities (i.e. potentially clinically relevant). Biochemistry included blood urea nitrogen, creatinine, serum glutamic oxalacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT), gamma-glutamyl transferase (GGT), phosphorous, total bilirubin, direct bilirubin, total protein, albumin, glucose, alkaline phosphatase, low density lipoprotein (LDH), uric acid, carbon dioxide, magnesium, sodium, potassium, chloride, calcium, LDL, HDL, total cholesterol, and triglycerides.|Up to 12 months|Safety population included all participants who received at least one dose of study drug (daclizumab or placebo) or commercially available daclizumab and have at least one post-baseline safety assessment (eg. any laboratory data, adverse event, etc). The number of participants analyzed for the specified parameters are denoted by ‘n’.||participants|||Number
701585|NCT00054717|Secondary|Virologic Response (VL < 400 Copies/ml) at Week 24|Percentage of participants with Viral Load < 400 copies/mL|Week 24|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
700375|NCT00048165|Secondary|Number of Participants With Marked Laboratory Abnormalities: Hematology Parameters|A marked reference range was predefined by Roche. The marked reference range is broader than the standard reference range. Values falling outside the marked reference range (low or high) that also represent a defined change from Baseline were considered marked laboratory abnormalities (i.e. potentially clinically relevant). Hematology included hemoglobin, hematocrit, white blood cell count (WBC) with differential (including granulocytes or neutrophils, basophils, eosinophils, monocytes, lymphocytes), platelets, and erythrocyte count|Up to 12 months|Safety population included all participants who received at least one dose of study drug (daclizumab or placebo) or commercially available daclizumab and have at least one post-baseline safety assessment (eg. any laboratory data, adverse event, etc). The number of participants analyzed for the specified parameters are denoted by ‘n’.||participants|||Number
700376|NCT00048165|Secondary|Median Change From Baseline for LDL/HDL Ratio||From Baseline (Day -2) to 3 months, and 6 months|The randomized population included all participants who were randomized into the study, whether they received the study drug or not.||ratio||Full Range|Median
700377|NCT00048165|Secondary|Median Change From Baseline for Lipid Profile (Total Cholesterol, Low Density Lipoproteins, High Density Lipoproteins, and Triglycerides)|Lipid profile included total cholesterol, low density lipoproteins (LDL), high density lipoproteins (HDL), and triglycerides (all total cholesterol, LDL, HDL, and triglycerides with unit milligram per decilitre [mg/dL]), were reported. The median change from baseline (Day -2) in lipid profile values at 3 months and 6 months was reported.|From Baseline (Day -2) to 3 months and 6 months|The randomized population included all participants who were randomized into the study, whether they received the study drug or not. The number of participants analyzed for the specified parameters are denoted by 'n'.||mg/dL||Full Range|Median
700378|NCT00048165|Secondary|Mean Maintenance Doses of Mycophenolate Mofetil, Cyclosporine, and Cumulative Dose of Corticosteroids at 6 and 12 Months PT|The maintenance doses of mycophenolate mofetil (1.5g twice a day daily), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg oral [PO]/nasogastric [NG] within 72 hours post-operative]), and cumulative dose of corticosteroids (500-1000 mg IV methylprednisolone pre-operative switched to oral at 0.5-1 mg/kg/day. Tapered to 0.2 mg/kg/d by Day 28, 0.1-0.15 mg/kg/day from Days 36 to 90, and 0.1-0.15 mg/kg/day from Days 120 to 180)at 6 and 12 months PT were reported. Maintenance dose was calculated as total dose per day summed over all days that a participant was administered drug within the specified time interval, divided by number of days that a participant took drug within that time interval.|Within 6 months and 12 months PT|The randomized population included all participants who were randomized into the study, whether they received the study drug or not. The number of participants analyzed for the specified timepoints are denoted by 'n'.||mg||Standard Deviation|Mean
700379|NCT00048165|Secondary|Number of Participants Using Monomurab Cluster of Differentiation 3, Orthoclone Polyclonal Antithymocyte Globulin or Antilymphocyte Globulin in the First 6 Months and 12 Months PT|The number of participants who received monomurab Cluster of differentiation 3, orthoclone, polyclonal antithymocyte globulin or antilymphocyte globulin for treatment of biopsy proven rejection or HDC within 6 and 12 months PT were reported.|Within 6 months and 12 months PT|The randomized population included all participants who were randomized into the study, whether they received the study drug or not.||participants|||Number
700380|NCT00048165|Secondary|Median Time to First Acute Rejection Episode Within the First 6 Months and 12 Months PT|The median time to first acute rejection episode within first 6 months and 12 months PT was reported.|Within 6 months and 12 months PT|The randomized population included all participants who were randomized into the study, whether they received the study drug or not. The number of participants analyzed for the specified timepoints are denoted by 'n'.||days||Full Range|Median
700381|NCT00048165|Secondary|Number of Participants With Worst ISHLT Biopsy Grade Within First 6 Months and 12 Months PT|The number of participants with Worst International Society of Heart and Lung Transplant (ISHLT) grade within first 6 months and 12 months PT were reported. ISHLT is a standardized grading method to determine the acute cellular rejection on endomyocardial biopsy ; where 0= no rejection, IA= focal (perivascular or interstitial) infiltrate without necrosis, IB= diffuse but sparse infiltrate without necrosis, II=one focus only with aggressive infiltration and/or focal myocyte damage, IIIA=multifocal aggressive infiltrates and/or myocyte damage, IIIB= diffuse inflammatory process with necrosis, IV= diffuse aggressive polymorphous and/or infiltrate and/or edema and/or hemorrhage and/or vasculitis, with necrosis|Within 6 months and 12 months PT|The randomized population included all participants who were randomized into the study, whether they received the study drug or not.||participants|||Number
700382|NCT00048165|Secondary|Number of Participant Who Died Within 6 Months 12 Months and 3 Years PT|The survival of the graft and participants at 6,12 months and 3 years PT was reported|At 6 months, 12 months , 3 years PT|The randomized population included all participants who were randomized into the study, whether they received the study drug or not.||participants|||Number
700383|NCT00048165|Secondary|Number of Acute Rejection Episodes Per Participant Within the First 6 Months and 12 Months PT|The number of participants with 0,1, 2, 3 or 4 episodes at 6 and 12 months PT were reported. An episode of acute rejection was defined according to the date of positive biopsy of Grade IIIA or worse or the date of start of treatment for HDC, whichever came first.|Within 6 months and 12 months PT|The randomized population included all participants who were randomized into the study, whether they received the study drug or not.||participants|||Number
700384|NCT00048165|Secondary|Number of Participants Who Developed Acute Rejection Episode Within the 12 Months PT|The acute rejection episode was a composite end-point of acute rejection and treatment failure within 6 months. Participants with acute rejection included participants with a biopsy histology of ISHLT Grade IIIA, IIIB, or IV and participants with hemodynamic compromise (HDC) who were treated for acute rejection (whether or not a biopsy was done and regardless of the grade of the biopsy). Participants who had treatment failure included participants who died within 6 months of transplantation before experiencing acute rejection or who were re-transplanted within 6 months of the primary transplantation and who did not experience an acute rejection or who were lost to follow-up|Up to 12 months PT|The randomized population included all participants who were randomized into the study, whether they received the study drug or not.||participants|||Number
701530|NCT00054132|Other Pre-specified|Percentage of Cells Staining Positive for VEGF Receptor (VEGFR)-1|Associations between markers and tumor response will be assessed by logistic regression analysis. For those markers that are statistically significant, a cut-point analysis will be performed by the maximum chi-square with p-value adjustment method to determine positive values.|Up to 12 years||||||
700385|NCT00048165|Primary|Number of Participants Who Developed Acute Rejection Episode Within 6 Months Post-Transplant|The acute rejection episode was a composite end-point of acute rejection and treatment failure within 6 months post-transplant (PT). Participants with acute rejection included participants with a biopsy histology of International Society of Heart and Lung Transplant (ISHLT) Grade IIIA, IIIB, or IV and participants with hemodynamic compromise (HDC) who were treated for acute rejection (whether or not a biopsy was done and regardless of the grade of the biopsy). Participants who had treatment failure included participants who died within 6 months of transplantation before experiencing acute rejection or who were re-transplanted within 6 months of the primary transplantation and who did not experience an acute rejection or who were lost to follow-up.|Up to 6 months PT|The randomized population included all participants who were randomized into the study, whether they received the study drug or not.||participants|||Number
700386|NCT00048347|Primary|Percent of Participants With at Least a 3 Point Drop in the Short Clinical Colitis Score (SCCAI)|The primary endpoint is the percent of patients with a clinical response as defined by a drop in the Short Clinical Colitis Score (SCCAI) of at least 3 points from Week 0 to Week 12. Short Clinical Colitis Score (SCCAI): Bowel frequency(day0-3,night0-2),urgency(0-3),rectal bleeding(0-3),well being(0-4),extracolonic features(0-4), total score 0(best)-19(worst).|Baseline, Week 12|||Percent of participants|||Number
700387|NCT00048542|Other Pre-specified|Baseline Measure: Age Continuous - OLE FD Phase|Age continuous (mean +/- SD) recorded at Baseline of the Open-Label Extension FD phase of the study. This measure was excluded from Baseline Characteristics due to difficulty maintaining correct subject numbers and Baseline value totals in that section with this phase included.|Baseline OLE FD Phase|||Years||Standard Deviation|Mean
700388|NCT00048542|Other Pre-specified|Baseline Measure: Gender, Female/Male - OLE FD Phase|Gender (female/male) recorded at Baseline of the Open-Label Extension FD phase of the study. This measure was excluded from Baseline Characteristics due to difficulty maintaining correct subject numbers and Baseline value totals in that section while including this phase of the study.|Baseline OLE FD Phase|||Participants|||Number
700389|NCT00048542|Other Pre-specified|Baseline Measure: Age Continuous - OLE BSA Phase|Age continuous (mean +/- SD) recorded at Baseline of the Open-Label Extension BSA phase of the study. This measure was excluded from Baseline Characteristics due to difficulty maintaining correct subject numbers and Baseline value totals in that section with this phase included.|Baseline OLE BSA Phase|||Years||Standard Deviation|Mean
700390|NCT00048542|Other Pre-specified|Baseline Measure: Gender, Female/Male - OLE BSA Phase|Gender (female/male) recorded at Baseline of the Open-Label Extension BSA phase of the study. This measure was excluded from Baseline Characteristics due to difficulty maintaining correct subject numbers and Baseline value totals in that section while including this phase of the study.|Baseline OLE BSA Phase|||Participants|||Number
700391|NCT00048542|Secondary|Number of Subjects Meeting PedACR30/50/70 Response Criteria at the Final Visit (up to 224 Weeks) of the Open-Label Extension Fixed Dose Phase|Responders met the following criteria: >= 30%/50%/70% improvement in >= 3 of 6 JIA core criteria, and >= 30% worsening in not more than 1 JIA criterion, compared with OL baseline. JIA core criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; # of active joints (joints with swelling or with LOM and with pain, tenderness or both); # of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. Final Visit = last visit per subject (up to 224 weeks).|Final Visit (up to 224 weeks of OLE FD phase)|The ITT population was used for analysis in the Open-Label Extension Fixed Dose phase.||Participants|||Number
700392|NCT00048542|Secondary|Number of Subjects Meeting PedACR30/50/70 Response Criteria at Week 112 of the Open-Label Extension Fixed Dose Phase|Responders met the following criteria: >= 30%/50%/70% improvement in >= 3 of 6 JIA core criteria, and >= 30% worsening in not more than 1 JIA criterion, compared with OL baseline. JIA core criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; # of active joints (joints with swelling or with LOM and with pain, tenderness or both); # of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. All core assessments are included in PedACR criteria.|Week 112|The ITT population was used for analysis in the Open-Label Extension Fixed Dose phase.||Participants|||Number
700393|NCT00048542|Secondary|Number of Subjects Meeting PedACR30/50/70 Response Criteria at Week 48 of the Open-Label Extension Fixed Dose Phase|Responders met the following criteria: >= 30%/50%/70% improvement in >= 3 of 6 JIA core criteria, and >= 30% worsening in not more than 1 JIA criterion, compared with OL-LI baseline. JIA core criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; # of active joints (joints with swelling or with LOM and with pain, tenderness or both); # of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. All core assessments are included in PedACR criteria.|Week 48|The ITT population was used for analysis in the Open-Label Extension Fixed Dose phase.||Participants|||Number
700394|NCT00048542|Secondary|Number of Subjects Meeting PedACR30/50/70 Response Criteria at Baseline of the Open-Label Extension Fixed Dose Phase|Responders met the following criteria: >= 30%/50%/70% improvement in >= 3 of 6 JIA core criteria, and >= 30% worsening in not more than 1 JIA criterion, compared with OL-LI baseline. JIA core criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; # of active joints (joints with swelling or with LOM and with pain, tenderness or both); # of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. All core assessments are included in PedACR criteria.|Baseline|The ITT population was used for analysis in the Open-Label Extension Fixed Dose phase.||Participants|||Number
700395|NCT00048542|Secondary|Number of Subjects Meeting PedACR30/50/70 Response Criteria at Week 104 of the Open-Label Extension Body Surface Area Phase|Responders met the following criteria: >= 30%/50%/70% improvement in >= 3 of 6 JIA core criteria, and >= 30% worsening in not more than 1 JIA criterion, compared with OL baseline. JIA core criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; # of active joints (joints with swelling or with LOM and with pain, tenderness or both); # of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. All core assessments are included in PedACR criteria.|Week 104|The ITT population was used for analysis in the Open-Label Extension Body Surface Area phase.||Participants|||Number
700396|NCT00048542|Secondary|Number of Subjects Meeting PedACR30/50/70 Response Criteria at Week 56 of the Open-Label Extension Body Surface Area Phase|Responders met the following criteria: >= 30%/50%/70% improvement in >= 3 of 6 JIA core criteria, and >= 30% worsening in not more than 1 JIA criterion, compared with OL baseline. JIA core criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; # of active joints (joints with swelling or with LOM and with pain, tenderness or both); # of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. All core assessments are included in PedACR criteria.|Week 56|The ITT population was used for analysis in the Open-Label Extension Body Surface Area phase.||Participants|||Number
700397|NCT00048542|Secondary|Number of Subjects Meeting PedACR30/50/70 Response Criteria at Baseline of the Open-Label Extension Body Surface Area Phase|Responders met the following criteria: >= 30%/50%/70% improvement in >= 3 of 6 JIA core criteria, and >= 30% worsening in not more than 1 JIA criterion, compared with OL baseline. JIA core criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; # of active joints (joints with swelling or with LOM and with pain, tenderness or both); # of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. All core assessments are included in PedACR criteria.|Open-Label Lead-In Phase Baseline|The ITT population was used for analysis in the Open-Label Extension Body Surface Area phase.||Participants|||Number
700398|NCT00048542|Secondary|Mean Change From Baseline in C-Reactive Protein Levels at Week 48 of the Double-Blind Phase|Serum levels of C-reactive protein (CRP) were measured at screening (open-label baseline) and at Week 48. Negative mean changes in CRP from open-label baseline to Week 48 indicated improvement.|Baseline and Week 48|All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug, who completed Week 48. Observed data of subjects who remained in the study at Week 48 were analyzed.||mg/dL||Standard Error|Mean
700399|NCT00048542|Secondary|Mean Change From Baseline in Parent's/Patient's Global Assessment of Disease Activity at Week 48 of the Double-Blind Phase|A 100 mm horizontal visual analog scale (VAS) was used to assess the Parent's/Patient's Global Assessment of Disease Activity. The left end of the VAS (0 mm) signified the absence of symptoms and the right end (100 mm) maximum disease activity. The mean change from open-label baseline to Week 48 was determined. Negative mean changes indicated improvement.|Baseline and Week 48|All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug, who completed Week 48. Observed data of subjects who remained in the study at Week 48 were analyzed.||Units on a scale||Standard Error|Mean
700400|NCT00048542|Secondary|Mean Change From Baseline in Physician's Global Assessment of Disease Activity at Week 48 of the Double-Blind Phase|A 100 mm horizontal visual analog scale (VAS) was used to assess the Physician Global Assessment of Disease Activity. The left end of the VAS scale (0 mm) signified the absence of symptoms and the right end (100 mm) maximum disease activity. The mean change from open-label baseline to Week 48 was determined. Negative mean changes indicated improvement.|Baseline and Week 48|All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug, who completed Week 48. Observed data of subjects who remained in the study at Week 48 were analyzed.||Units on a scale||Standard Error|Mean
700401|NCT00048542|Secondary|Number of Subjects Meeting PedACR70 Response Criteria at the End of the Double-Blind Phase|Responders met the following criteria: >= 70% improvement in >= 3 of 6 JIA core set criteria, and >= 30% worsening in not more than 1 JIA criterion, compared with the OL baseline. JIA core criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; number of active joints (joints with swelling or with LOM and with pain, tenderness or both); number of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. All core variables are included in PedACR criteria.|Week 48|All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug. Missing values were treated as non-responders.||Participants|||Number
700402|NCT00048542|Secondary|Number of Subjects Meeting PedACR50 Response Criteria at the End of the Double-Blind Phase|Responders met the following criteria: >= 50% improvement in >= 3 of 6 JIA core set criteria, and >= 30% worsening in not more than 1 JIA criterion, compared with the OL baseline. JIA core criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; number of active joints (joints with swelling or with LOM and with pain, tenderness or both); number of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. All core variables are included in PedACR criteria.|Week 48|All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug. Missing values were treated as non-responders.||Participants|||Number
700403|NCT00048542|Secondary|Number of Subjects Meeting PedACR30 Response Criteria at the End of the Double-Blind Phase|Responders met the following criteria: >= 30% improvement in >= 3 of 6 JIA core set criteria, and >= 30% worsening in not more than 1 JIA criterion, compared with the OL baseline. JIA core criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; number of active joints (joints with swelling or with LOM and with pain, tenderness or both); number of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. All core criteria are included in PedACR criteria.|Week 48|All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug. Missing values were treated as non-responders.||Participants|||Number
700404|NCT00048542|Secondary|Time to Onset of Disease Flare During the Double-Blind Phase in Subjects in the MTX Stratum|A log rank test was performed and the Kaplan-Meier curve for time to disease flare from double-blind baseline (Week 16) to Week 48 was generated. Disease flare was defined as a >= 30% worsening in at least 3 of 6 JRA core set criteria and a minimum of 2 active joints, and >= 30% improvement in not more than 1 JRA criterion. The percentage of subjects without disease flare at each time point is presented.|Week 16 to Week 48 (32 weeks)|All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug, in the MTX stratum.||Percent participants w/o disease flare|||Number
700405|NCT00048542|Secondary|Time to Onset of Disease Flare During the Double-Blind Phase in Subjects in the Non-MTX Stratum|A log rank test was performed and the Kaplan-Meier curve for time to disease flare from double-blind baseline (Week 16) to Week 48 was generated. Disease flare was defined as a >= 30% worsening in at least 3 of 6 JRA core set criteria and a minimum of 2 active joints, and >= 30% improvement in not more than 1 JRA criterion. The percentage of subjects without disease flare at each time point is presented.|Week 16 to Week 48 (32 weeks)|All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug, in the non-MTX stratum.||Percent participants w/o disease flare|||Number
700406|NCT00048542|Secondary|Number of Subjects in the MTX Stratum With Disease Flare During the Double-Blind Phase|Subjects met criteria for disease flare if they had >= 30% worsening in at least 3 of 6 JRA core set criteria and a minimum of 2 active joints, and >= 30% improvement in not more than 1 JRA criterion. JRA core set criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; number of active joints (joints with swelling or with LOM and with pain, tenderness or both); number of joints with LOM; physical function of Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein.|Week 16 to Week 48 (32 Weeks)|All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug, in the MTX stratum. Missing values were treated as disease flare.||Participants|||Number
700407|NCT00048542|Secondary|Number of Subjects Meeting Pediatric American College of Rheumatology 30% (PedACR30) Response Criteria at the End of the Open-Label Lead-In Phase|Responders met the following criteria: >= 30% improvement in >= 3 of 6 JRA core set criteria, and >= 30% worsening in not more than 1 JRA criterion, compared with the open-label baseline. JRA core set criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; number of active joints (joints with swelling or with limitation of motion [LOM] and with pain, tenderness or both); number of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein.|Week 16|All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug. Missing values were treated as non-responders.||Participants|||Number
700408|NCT00048542|Primary|Number of Subjects in the Non-MTX Stratum With Disease Flare During the Double-Blind Phase|The primary efficacy endpoint was the number of adalimumab-treated subjects in the non-MTX stratum with disease flare during the Double-Blind Phase compared with the number of placebo-treated subjects in the non-MTX stratum with disease flare during the double-blind phase. Subjects met the criteria for disease flare if they had 1) >= 30% worsening in at least 3 of the 6 Juvenile Rheumatoid Arthritis (JRA) core set criteria and a minimum of 2 active joints, and 2) >= 30% improvement in not more than 1 of the 6 JRA core set criteria.|Week 16 to Week 48 (32 weeks)|All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug, in the non-MTX stratum. Missing values were treated as disease flare.||Participants|||Number
700409|NCT00048568|Secondary|Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 2,185 for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
700410|NCT00048568|Secondary|Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 2,185 Cohort of Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
700411|NCT00048568|Secondary|Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,989 for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 1,989|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
700452|NCT00048568|Primary|Mean Change From BL in Liver Function Parameters in the OL Period|All changes in participant laboratory parameters were monitored on each day of study drug administration.|BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185|All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.||U/L||Standard Error|Mean
706184|NCT00105482|Secondary|Point Prevalence Smoking Abstinence at 6 Weeks|The number of people that were abstinent from cigarette smoking at 6 weeks.|6 weeks|All patients who were randomized comprised the primary ITT population.||participants|||Number
700412|NCT00048568|Secondary|Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,989 Cohort of Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 1,989|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
700413|NCT00048568|Secondary|Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,821 for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 1,821|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
700414|NCT00048568|Secondary|Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,821 Cohort of Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 1,821|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
700415|NCT00048568|Secondary|Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,625 for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 1,625|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
700416|NCT00048568|Secondary|Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,625 Cohort of Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 1,625|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
700417|NCT00048568|Secondary|Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,457 for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 1,457|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
700418|NCT00048568|Secondary|Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,457 Cohort of Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 1,457|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
700419|NCT00048568|Secondary|Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,345 for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 1,345|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
700420|NCT00048568|Secondary|Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,345 Cohort of Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 1,345|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
700421|NCT00048568|Secondary|Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,261 for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 1,261|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
700422|NCT00048568|Secondary|Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,261 Cohort of Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 1,261|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
700423|NCT00048568|Secondary|Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,177 for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 1,177|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
700424|NCT00048568|Secondary|Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,177 Cohort of Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 1,177|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
700425|NCT00048568|Secondary|Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,093 for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 1,093|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
700426|NCT00048568|Secondary|Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,093 Cohort of Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 1,093|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
700427|NCT00048568|Secondary|Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 981 for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 981|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis.||Units on a Scale||Standard Error|Mean
700428|NCT00048568|Secondary|Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 981 Cohort of Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 981|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
700429|NCT00048568|Secondary|Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 897 for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 897|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
700430|NCT00048568|Secondary|Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 897 Cohort of Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 897|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
700431|NCT00048568|Secondary|Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 813 for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 813|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
700432|NCT00048568|Secondary|Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 813 Cohort of Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 813|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
701586|NCT00054717|Secondary|Virologic Response (VL < 400 Copies/ml) at Week 16|Percentage of participants with Viral Load < 400 copies/mL|Week 16|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
700433|NCT00048568|Secondary|Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 729 for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 729|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
700434|NCT00048568|Secondary|Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 729 Cohort of Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 729|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
700435|NCT00048568|Secondary|Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 617 for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 617|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
700436|NCT00048568|Secondary|Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 617 Cohort of Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 617|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
700437|NCT00048568|Secondary|Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 533 for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 533|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
700438|NCT00048568|Secondary|Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 533 Cohort of Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 533|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
700439|NCT00048568|Secondary|Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 449 for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 449|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
700440|NCT00048568|Secondary|Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 449 Cohort of Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 449|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
700441|NCT00048568|Secondary|Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 365 for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 365|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
700442|NCT00048568|Secondary|Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 365 Cohort of Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 365|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
700443|NCT00048568|Secondary|Mean Change From BL in E-Selectin, SICAM-1, and MMP3 in the DB Period|The mean change from basline in particpant biomarkers of RA disease (E-Selectin, SICAM-1, and MMP3) after 6 months and 1 year of treatment, relative to baseline, were evaluated.|BL (Day 0), Day 169, Day 365|All treated participants in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.||ng / mL||Standard Error|Mean
700444|NCT00048568|Secondary|Mean BL E-Selectin, SICAM-1, and MMP3 in the DB Period|Mean baseline values are reported for each cohort at each time point. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 169, Day 365|All treated participants in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.||ng / mL||Standard Error|Mean
700445|NCT00048568|Secondary|Mean Change From BL in RF in the DB Period|The mean change from baseline in participant rheumatoid factor was determined after 6 months and 1 year of treatment relative to baseline. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 169, Day 365|All treated participants in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.||IU / mL||Standard Error|Mean
700446|NCT00048568|Secondary|Mean Change From BL in Interleukin-6 (IL-6), SIL-2R, and Tumor Necrosis Alpha (TNF-Alpha) in the DB Period|The mean change from baseline in potential biomarkers of disease (IL-6, SIL-3R, and TNF-Alpha were determined for all participants.|BL (Day 0), Day 169, Day 365|All treated participants in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.||pg / mL||Standard Error|Mean
700447|NCT00048568|Secondary|Mean BL Interleukin-6 (IL-6), SIL-2R, and Tumor Necrosis Alpha (TNF-Alpha) in the DB Period|Mean baseline values are reported for each cohort at each time point. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 169, Day 365|All treated participants in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.||pg / mL||Standard Deviation|Mean
700448|NCT00048568|Primary|Mean Change From BL in Serum Electrolytes in the OL Period|All changes in participant laboratory parameters were monitored on each day of study drug administration.|BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185|All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.||mEq/L||Standard Error|Mean
700449|NCT00048568|Primary|Mean BL Serum Electrolytes in the OL Period|Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185.|BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185|All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.||mEq/L||Standard Deviation|Mean
700450|NCT00048568|Primary|Mean Change From BL in Select Laboratory Parameters in the OL Period|All changes in participant laboratory parameters were monitored on each day of study drug administration.|BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185|All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.||mg/dL||Standard Error|Mean
700453|NCT00048568|Primary|Mean BL Liver Function Parameters in the OL Period|Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185.|BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185|All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.||U/L||Standard Deviation|Mean
700454|NCT00048568|Primary|Mean Change From BL in White Blood Cells in the OL Period|All changes in participant laboratory parameters were monitored on each day of study drug administration.|BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185|All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.||10^3 c/uL||Standard Error|Mean
700455|NCT00048568|Primary|Mean BL White Blood Cells in the OL Period|Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185.|BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185|All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.||10^3 c/uL||Standard Deviation|Mean
700456|NCT00048568|Secondary|Mean Change From BL in Limitations on Activities of Daily Living in the OL Period|The mean change from baseline in limitations on activities of daily living in the OL period. Activity limitation was measured by the number of days in the past 30 days a participant was unable to perform usual activities due to RA.|BL (Day 0), Day 365, Day 449, Day 533, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Days||Standard Error|Mean
700457|NCT00048568|Secondary|Mean BL Limitations on Activities of Daily Living in the OL Period|Mean baseline values are reported for each cohort at each time point. Activity limitation was measured by the number of days in the past 30 days a participant was unable to perform usual activities due to RA. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 365, Day 449, Day 533, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Days||Standard Deviation|Mean
700458|NCT00048568|Secondary|Mean Change From BL in Sleep Quality in the OL Period|The mean change from baseline in sleep quality was assessed on the Medical Outcomes Study Sleep scale (MOS-sleep [assesses the extent of sleep problems and measures six dimensions of sleep on a 12-item participant-reported measure]). An overall Sleep Problems Index (SPI) was generated as a summary measure of different types of sleep problems (sleep disturbance, sleep quantity, sleep adequacy, etc.). The score ranges from 0 to 100, with 0 = no problems with sleep and 100 = the most severe problems with sleep. The mean score of the SPI in a population with chronic conditions is 29.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
700459|NCT00048568|Secondary|Mean BL Sleep Quality in the OL Period|Mean baseline values are reported for each cohort at each time point using the Medical Outcomes Study Sleep scale (MOS-sleep [assesses the extent of sleep problems and measures six dimensions of sleep on a 12-item participant-reported measure]). An overall Sleep Problems Index (SPI) was generated as a summary measure of different types of sleep problems (sleep disturbance, sleep quantity, sleep adequacy, etc.). The score ranges from 0 to 100, with 0 = no problems with sleep and 100 = the most severe problems with sleep. The mean score of the SPI in a population with chronic conditions is 29.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
700460|NCT00048568|Secondary|Mean Change From BL in Fatigue in the OL Period|The mean change from baseline in fatigue was measured on the VAS 100 mm where 0= no fatigue to 100 = the worst fatigue imaginable.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
700461|NCT00048568|Secondary|Mean BL Fatigue in the OL Period|Mean baseline values are reported for each cohort at each time point using the VAS 100 mm where 0= no fatigue to 100 = the worst fatigue imaginable. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
706185|NCT00105482|Secondary|Weight Gain at 6 Weeks.|Weight change from baseline measured at 6 weeks.|6 weeks|All patients who were randomized comprised the primary ITT population.||pounds||Standard Deviation|Mean
700462|NCT00048568|Secondary|Mean Change From BL by Visit in the Mental Health Component of the SF-36 in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
700463|NCT00048568|Secondary|Mean BL Mental Health Component of the SF-36 by Visit in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
700464|NCT00048568|Secondary|Mean Change From BL by Visit in the Vitality Component of the SF-36 in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
700465|NCT00048568|Secondary|Mean BL Vitality Component of the SF-36 by Visit in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
700466|NCT00048568|Secondary|Mean Change From BL by Visit in the Role-Emotional Component of the SF-36 in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
700467|NCT00048568|Secondary|Mean BL Role-Emotional Component of the SF-36 by Visit in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
700484|NCT00048568|Primary|Number of Participants Experiencing Clinically Significant Changes in Vital Signs in the OL Period|Vital signs included body temperature, heart rate, and seated blood pressure. Clinically significant changes were defined as those that were not within the normal range for the participant.|Day 365 to Day 1,821. All changes in participant vital signs were monitored on each day of study drug administration prior to dosing and 60 minutes after dosing.|All treated participants entering the OL period.||Participants|||Number
700468|NCT00048568|Secondary|Mean Change From BL by Visit in the Social Functioning Component of the SF-36 in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
700469|NCT00048568|Secondary|Mean BL Social Functioning Component of the SF-36 by Visit in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
700470|NCT00048568|Secondary|Mean Change From BL by Visit in the General Health Component of the SF-36 in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
700471|NCT00048568|Secondary|Mean BL General Health Component of the SF-36 by Visit in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
700472|NCT00048568|Secondary|Mean Change From BL by Visit in the Bodily Pain Component of the SF-36 in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
700473|NCT00048568|Secondary|Mean BL Bodily Pain Component of the SF-36 by Visit in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|AlAll treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
700666|NCT00048997|Primary|Overall Survival|Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. This analysis was planned to occur when all patients had been potentially followed for at least 12 months.|After all patients have been potentially followed for a minimum of 12 months|All eligible patients||months||95% Confidence Interval|Median
700474|NCT00048568|Secondary|Mean Change From BL by Visit in the Role-Physical Component of the SF-36 in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
700475|NCT00048568|Secondary|Mean BL Role-Physical Component of the SF-36 by Visit in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
700476|NCT00048568|Secondary|Mean Change From BL by Visit in the Physical Function Component of the SF-36 in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
700477|NCT00048568|Primary|Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period|All changes in participant laboratory parameters were monitored on each day of study drug administration.|BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185|All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.||g/dL||Standard Error|Mean
700478|NCT00048568|Primary|Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period|Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185.|BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185|All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.||g/dL||Standard Deviation|Mean
700479|NCT00048568|Primary|Mean Change From BL in Participant Platelet Count in the OL Period|All changes in participant laboratory parameters were monitored on each day of study drug administration.|BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185|All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.||10^9 c/L||Standard Error|Mean
700480|NCT00048568|Primary|Mean BL Platelet Count in the OL Period|Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185.|BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185|All treated participants in the OL period (treatment groups represent treatment received in the double-blind period).N = number of participants analyzed and n = the number of participants with measurements for that time point.||10^9 c/L||Standard Deviation|Mean
700481|NCT00048568|Primary|Mean Change From BL in Participant Hematocrit in the OL Period|All changes in participant laboratory parameters were monitored on each day of study drug administration.|BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185|All treated participants in the OL period (treatment groups represent treatment received in the double-blind period).N = number of participants analyzed and n = the number of participants with measurements for that time point.||Percentage Blood Volume Occupied by RBCs||Standard Error|Mean
700482|NCT00048568|Primary|Mean BL Hematocrit in the OL Period|Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185.|Baseline (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185|All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.||Percentage of Red Blood Cells||Standard Deviation|Mean
700483|NCT00048568|Primary|Number of Participants Experiencing AEs of Special Interest in the OL Period|AEs were defined as any new untoward medical occurrence or worsening of a pre- existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest have been identified to be those which may be associated with the use of immunomodulatory agents or infusion of therapeutic proteins. Acute infusional AEs were defined as those that occurred within 1 hour after the start of the infusion.|Day 365 to Day 2,185|All treated participants in the OL period.||Participants|||Number
700485|NCT00048568|Secondary|Mean BL Physical Function Component of the SF-36 by Visit in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
700486|NCT00048568|Secondary|Mean Change From BL by Visit in the Mental Component Summary of the SF-36 in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
700487|NCT00048568|Secondary|Mean BL Mental Component Summary of the SF-36 by Visit in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
700488|NCT00048568|Secondary|Mean Change From BL by Visit in the Physical Component Summary of the SF-36 in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 14,57, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
700489|NCT00048568|Secondary|Mean BL Physical Component Summary of the SF-36 by Visit in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 14,57, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
700490|NCT00048568|Secondary|BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period|Change from baseline in the Genant-modified Sharp erosion score, JSN, TS were evaluated for all participants at the end of the OL period. The total Genant-modified Sharp score (TS) ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145).Higher scores indicated more damage. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
700667|NCT00049036|Primary|Complete Response Proportion as Measured by Tumor Response After Completion of Study Treatment|Complete response defined by the International Response Criteria for Non-Hodgkin's Lymphoma|60 days|ITT||proportion|||Number
700668|NCT00049127|Secondary|Overall Time to Death|Kaplan-Meier survival curves and logrank tests will be used to estimate survival distributions.|Time from date of registration to date of death due to any cause or last follow-up, assessed up to 5 years|||months||95% Confidence Interval|Median
700491|NCT00048568|Secondary|Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Participants|||Number
700492|NCT00048568|Primary|Participants With Immunogenicity to Abatacept in the Cumulative DB + OL Period|Participants with titers to abatacept in the DB and OL periods. Serum samples from abatacept-treated adult participants with active Rheumatoid Arthritis (RA) were screened for the presence of drug-specific antibodies using two validated direct-format enzyme-linked immunosorbent assays (ELISAs) to determine the presence of antibodies to abatacept and or CTLA4-T.|Day 1 to Day 1,821|Participants with serum samples available for evaluation of titers to abatacept.||Participants|||Number
700493|NCT00048568|Primary|Mean Change From BL in Immunoglobulins in the OL Period||BL (Day 0), Day 365, Day 729, Day 1,093|All treated participants in the OL period (treatment groups represent treatment received in the double-blind period).||mg / mL||Standard Error|Mean
700494|NCT00048568|Primary|Mean BL Immunoglobulins Over Time in the OL Period|Mean baseline values are those that are reported for each cohort at each time point on Day 365, Day 729, and Day 1,093.|BL (Day 0), Day 365, Day 729, Day 1,093|All treated participants in the OL period (treatment groups represent treatment received in the double-blind period).||mg / mL||Standard Deviation|Mean
700495|NCT00048568|Secondary|Mean Change From BL in DAS-28 ESR Over Time in the OL Period|Change from baseline in participant serum values of ESR were calculated at all study visits in the OL period.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||IU / mL||Standard Error|Mean
700496|NCT00048568|Secondary|Mean BL DAS-28 ESR Over Time in the OL Period|Mean baseline values are reported for each cohort at each time point. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||IU / mL||Standard Deviation|Mean
700497|NCT00048568|Secondary|Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period|Change from baseline in participant were calculated at all study visits in the DB and OL periods.|BL(Day 0),Day 15,Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||mg / mL||Standard Error|Mean
700498|NCT00048568|Secondary|Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period|Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL(Day 0), Day 15, Day 29,Day 57,Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||mg / mL||Standard Deviation|Mean
700499|NCT00048568|Secondary|Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time|The DAS 28 is a continuous measure evaluating extent of disease activity in RA, and is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, erythrocyte sedimentation rate (ESR) and participant assessment of disease activity measure on a visual analog scale (VAS) of 100 mm. The scale reports from 1 to 10, with increasing number indicating increasing extent of disease progression. Scores for disease activity are defined as high (> 5.1); low (≤ 3.2); remission (< 2.6).|Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Participants|||Number
700520|NCT00048568|Primary|Participants With Deaths, Adverse Events (AEs) and SAEs in the Open-Label (OL) Period|AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE was defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|Day 365 to Day 2,185|All treated participants in the OL period.||Participants|||Number
700500|NCT00048568|Secondary|Number of ACR 70 Responders in the DB and OL Periods|ACR 70 response requires a patient to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, CRP or ESR, and degree of disability in HAQ score. A participant achieved a sustained ACR 70 response if the participant had ACR 70 observed for at least 2 consecutive study visits.|Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Participants|||Number
700501|NCT00048568|Secondary|Number of ACR 50 Responders in the DB and OL Periods|ACR 50 response requires a patient to have a 50% reduction in the number of swollen and tender joints, and a reduction of 50% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, CRP or ESR, and degree of disability in HAQ score.|Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Participants|||Number
700502|NCT00048568|Secondary|Number of ACR 20 Responders in the DB and OL Periods|ACR 20 response requires a patient to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, CRP or ESR, and degree of disability in HAQ score. A participant achieved a sustained ACR 20 response if the participant had ACR 20 observed for at least 2 consecutive study visits.|Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Participants|||Number
700503|NCT00048568|Secondary|Participant RF Seroconversion in the OL Period|This analysis determined participant RF status (positive or RF negative) based on serum samples at each specified timepoint. A positive value for RF was > 20 IU/ml; a negative value for RF was ≤ 20 IU/mL.|Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 2,185|All treated participants in the OL period. Treatment groups represent treatment received in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Participants|||Number
700504|NCT00048568|Secondary|Mean Change From BL in ESR in the OL Period|Serum samples were evaluated from study participants to determine the mean change from baseline in ESR values.|BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period. Treatment groups represent treatment received in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.||IU / mL||Standard Error|Mean
700505|NCT00048568|Secondary|Mean BL ESR and CRP Levels in the OL Period|Mean baseline values are reported for each cohort at each time point.|BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period. Treatment groups represent treatment received in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.||IU / mL||Standard Deviation|Mean
700506|NCT00048568|Secondary|Number of Participants With Liver and Kidney Function Tests Meeting Marked Abnormality Criteria in the DB Period|Marked abnormality criteria were: Aspartate Aminotransferase (AST) >3 * ULN or if BL > ULN then use >4 *BL; Alanine Aminotransferase (ALT) >3 * ULN or if BL > ULN then use > 4 * BL; Creatinine > 1.5 * BL.|Day 1 to Day 365|All treated participants in the DB period.||Participants|||Number
700507|NCT00048568|Secondary|Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria in the DB Period|Marked abnormality criteria were: Hemoglobin (HGB): >3 g/dL decrease from BL; Hematocrit: <0.75 * BL; Erythrocytes: <0.75 * BL; Platelets (PLT): <0.67 * LLN/>1.5 * ULN, or if BL < LLN then use <0.5 * BL and <100,000 mm^3; Leukocytes: <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL or >ULN, or if BL>ULN then use >1.2 * BL or <LLN; neutrophils+bands: <1.0 * 10^3 c/uL; eosinophils: >0.750 * 10^3 c/uL; basophils: > 400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750 * 10^3 c/uL/ >7.50 * 10^3 c/uL.|Day 1 to Day 365|All treated participants in the DB period.||Participants|||Number
700508|NCT00048568|Secondary|Number of Participants Experiencing a 100% Reduction in Tender Joints or 100% Reduction in Swollen Joints in the DB Period||Day 169, Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis.||Participants|||Number
700509|NCT00048568|Secondary|Number of New Tender Joints and Number of New Swollen Joints in the DB Period|Tender joints and swollen joints are core components of the ACR 20, 50, and 70. The incidences of new tender joints and new swollen joints were evaluated in the DB period after 6 months and 1 year of treatment.|Day 169, Day 365|These data were not summarized as it was determined that no meaningful information would be obtained.||Joints|||Number
700510|NCT00048568|Secondary|Number of Participants With Immunogenicity to Abatacept in the DB Period|Participants with titers to abatacept in the DB period. Serum samples from abatacept-treated adult participants with active RA were screened for the presence of drug-specific antibodies using two validated direct-format enzyme-linked immunosorbent assays (ELISAs) to determine the presence of antibodies to abatacept and/or CTLA4-T.|Day 1 to Day 365|Participants treated with abatacept in the DB period with at least one immunogenicity sample collected in the DB period.||Participants|||Number
701552|NCT00054327|Secondary|Graft-versus-host Disease (GVHD)|Number of patients that develop acute graft-versus-host disease by grades 0-4. Grade O is no development of GVHD. Grade 1-4 is increase severity of skin, liver and gut involvement with 1 being least severe and 4 being most severe.|at 100 days post transplant|||participants|||Number
700511|NCT00048568|Secondary|Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 365|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis.||Units on a Scale||Standard Error|Mean
700512|NCT00048568|Secondary|Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 169|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|Day 169|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis.||Units on a Scale||Standard Error|Mean
700513|NCT00048568|Secondary|Mean BL Individual Components of the HAQ DI at Day 169 and Day 365|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 169, Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
700514|NCT00048568|Secondary|Participants Experiencing AEs of Special Interest in the DB Period|AEs were defined as any new untoward medical occurrence or worsening of a pre- existing medical condition which does not necessarily have a causal relationship with this treatment. AEs were identified as those which may be associated with the use of immunomodulatory agents or infusion of therapeutic proteins. Acute infusional AEs were defined as those that occurred within 1 hour after the start of the infusion.|Day 1 to Day 365|All treated participants in the DB period.||Participants|||Number
700515|NCT00048568|Secondary|Participants Experiencing Clinically Significant Changes in Vital Signs in the DB Period|All changes in participant vital signs were monitored on each day of study drug administration prior to dosing and 60 minutes after dosing. Vital signs included body temperature, heart rate, and seated blood pressure. Clinical significance was defined as any change from baseline that resulted in a value outside the normal limits for the participant.|Day 1 to Day 365|All randomized and treated participants.||Participants|||Number
700516|NCT00048568|Primary|Participants With Glucose, Protein, Metabolites, and Urinalysis Values Meeting the Marked Abnormality Criteria in the OL Period|Glucose: < 65 mg/dL or > 220 mg/dL; Fasting Glucose: <0.8 * LLN or > 1.5 * ULN or if BL < LLN then use < 0.8 * BL or > ULN or if BL > ULN then use 1.1 * BL or < LLN; Total protein: < 0.9 * LLN or 1.1 * ULN or if BL < LLN then use 0.9 * BL or > ULN or if BL > ULN then use 1.1 * BL or < LLN; Albumin: < 0.9 * LLN or if BL < LLN then use 0.75 * BL; Uric acid: > 1.5 * ULN or if BL > ULN then use > 2.0 * BL. All urinalysis abnormalities were defined as: if missing BL then use >= 2 or if value >=4, or if BL = 0 or 0.5 then use >= 2, or if BL = 1.0 then use >= 3, or if BL = 2.0 then use >=4.|Day 365 to Day 2,185|All treated participants in the OL period.||Participants|||Number
700517|NCT00048568|Primary|Participants With Electrolyte Values Meeting the Marked Abnormality Criteria in the OL Period|Sodium < 0.9 * LLN or > 1.05 * ULN or if BL < LLN then use < 0.95 * BL or > ULN or if BL > ULN then use >1.05 *BL or < LLN; Potassium: < 0.9 * LLN or > 1.1 * ULN or if BL < LLN then use < 0.9 * BL or > ULN or if BL > ULN then use 1.1 * BL or < LLN; Chloride: < 0.9 * LLN or > 1.1 * ULN or if BL < LLN then use <0.9 * BL or >ULN or if BL > ULN then use > 1.1 * BL or < LLN; Calcium <0.8 * LLN or > 1.2 * ULN or if BL < LLN then use <0.67 * BL or > ULN or if BL > ULN then use > 1.3 * BL or < LLN.|Day 365 to Day 2,185|All treated participants in the OL period.||Participants|||Number
700518|NCT00048568|Primary|Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria in the OL Period|Marked abnormality criteria are: Hemoglobin (HGB): >3 g/dL decrease from BL; Hematocrit: <0.75 * BL; Erythrocytes: <0.75 * BL; Platelets (PLT): <0.67 * LLN/>1.5 * ULN, or if BL < LLN then use <0.5 * BL and <100,000 mm^3; Leukocytes: <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL or >ULN, or if BL>ULN then use >1.2 * BL or <LLN; neutrophils+bands: <1.0 * 10^3 c/uL; eosinophils: >0.750 * 10^3 c/uL; basophils: > 400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750 * 10^3 c/uL/ >7.50 * 10^3 c/uL.|Day 365 to Day 2,185|All treated participants in the OL period.||Participants|||Number
700519|NCT00048568|Primary|Participants With Hematology Values Meeting the Marked Abnormality Criteria in the OL Period|Marked abnormality criteria are: Hemoglobin (HGB): >3 g/dL decrease from BL; Hematocrit: <0.75 * BL; Erythrocytes: <0.75 * BL; Platelets (PLT): <0.67 * LLN/>1.5 * ULN, or if BL < LLN then use <0.5 * BL and <100,000 mm^3; Leukocytes: <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL or >ULN, or if BL>ULN then use >1.2 * BL or <LLN; neutrophils+bands: <1.0 * 10^3 c/uL; eosinophils: >0.750 * 10^3 c/uL; basophils: > 400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750 * 10^3 c/uL/ >7.50 * 10^3 c/uL.|Day 365 to Day 2,185|All treated participants in the OL period.||Participants|||Number
700531|NCT00048568|Secondary|Mean BL Soluble Interleukin-2 Receptors (sIL2-r) in the DB Period|The mean baseline sIL2-r in the DB period was evaluated from serum samples for all treated participants.|BL (Day 0), Day 169, Day 365|All treated subjects in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.||mg / mL||Standard Deviation|Mean
725993|NCT00358826|Other Pre-specified|Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) - MDCT Substudy||Baseline and 24 weeks|Evaluable Population of the MDCT substudy||mg/L||Inter-Quartile Range|Median
700521|NCT00048568|Secondary|Change From BL in Joint Narrowing Score (JSN), Erosion Score (ES), and Total Score (TS) by Category in the DB Period|To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions and joint space narrowing (JSN). The total Genant-modified Sharp score ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145). Higher scores indicated more damage. Improvement=decreases from BL, stable=same as BL, worsening=increases from BL.|BL (Day 0), Day 365|This analysis was not completed.||Participants|||Number
700522|NCT00048568|Secondary|Number of Participants Discontinuing in the DB Period|Participants that discontinued treatment during the DB period for any reason were evaluated after 6 months and 1 year of treatment.|Day 1 to Day 169, Day 170 to Day 365|All randomized and treated participants in the DB period.||Participants|||Number
700523|NCT00048568|Secondary|ACR Core Component: Mean CRP at All Post-BL Visits in the DB Period|CRP core component of the ACR scoring system was evaluated from serum samples in which increasing levels indicate increasing level of disease.|Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.||IU / mL||Standard Deviation|Mean
700524|NCT00048568|Secondary|ACR Core Component: Mean Physician Global Assessment at All Post-BL Visits in the DB Period|Physician global RA assessment core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100mm Visual Analog Scale (VAS) with 0mm representing very good global RA assessment and 100mm representing very poor global RA assessment.|Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
700525|NCT00048568|Secondary|ACR Core Component: Mean Participant Global Assessment at All Post-BL Visits in the DB Period|Participant self-reported global RA assessment core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100mm Visual Analog Scale (VAS) with 0mm representing no pain and 100mm representing the most pain possible.|Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
700526|NCT00048568|Secondary|ACR Core Component: Mean Participant Physical Function Assessment at All Post-BL Visits in the DB Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
700527|NCT00048568|Secondary|ACR Core Component: Mean Participant Pain Assessment at All Post-BL Visits in the DB Period|Participant self-reported pain assessment core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100mm Visual Analog Scale (VAS) with 0mm representing no pain and 100mm representing the most pain possible.|Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
700528|NCT00048568|Secondary|ACR Core Component: Mean Number of Swollen Joints at All Post-BL Visits in the DB Period|The mean number of swollen joints in the DB period was evaluated based on the swollen joint core component of the ACR scoring system where increasing score indicates increasing level of severity. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.||joints||Standard Deviation|Mean
700529|NCT00048568|Secondary|ACR Core Component: Mean Number of Tender Joints at All Post-BL Visits in the DB Period|Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.||Joints||Standard Deviation|Mean
700530|NCT00048568|Secondary|Mean Change From BL in Soluble Interleukin-2 Receptors (sIL2-r) in the DB Period|The mean change from baseline in sIL2-r in the DB period was evaluated for all treated participants.|BL (Day 0), Day 169, Day 365|All treated subjects in the DB period.||mg / mL||Standard Error|Mean
700532|NCT00048568|Secondary|Adjusted Mean Change From BL in DAS-28 CRP and ESR in the DB Period|The mean change from baseline in CRP and ESR in the DB period was evaluated for all treated participants. Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|BL (Day 0), Day 169, Day 365|Due to the closure of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||mg / mL||Standard Error|Mean
700533|NCT00048568|Secondary|Mean BL DAS-28 C-Reactive Protein (CRP) and ESR in the DB Period|The mean baseline CRP and ESR in the DB period on Day 169 and Day 365 was evaluated for all treated participants. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 169, Day 365|Analyses of efficacy were based on the intent-to-treat population.Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last Observation Carried Forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.||mg / mL||Standard Deviation|Mean
700534|NCT00048568|Secondary|Participants in the DB Period Achieving an Extended Major Clinical Response|An extended major clinical response (MCR) was defined as a continuous ACR 70 response over any nine month treatment period with study medications. ACR 70 response criteria requires a patient to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score.|Day 1 to Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.||Participants|||Number
700535|NCT00048568|Secondary|Adjusted Mean Change From BL in the Physical Component Summary of Health-Related Quality of Life (SF-36) in the DB Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.|BL (Day 0), Day 169, Day 365|Analyses of efficacy were based on the intent-to-treat population.Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last Observation Carried Forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
700536|NCT00048568|Secondary|Mean DB BL Physical Component Summary of Health-Related Quality of Life (SF-36)|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 169, Day 365|Analyses of efficacy were based on the intent-to-treat population.Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last Observation Carried Forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
700537|NCT00048568|Secondary|Mean DB BL and Mean Change From BL in Joint Space Narrowing (JSN) and Total Score (TS)|To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions and joint space narrowing (JSN). The total Genant-modified Sharp score ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145). Higher scores indicated more damage. Change from baseline = Post-baseline - Baseline value.|BL (Day 0), Day 365|All randomized and treated participants in the DB period with radiographic data available at baseline and Day 365. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.||Units on a Scale||Standard Deviation|Mean
700538|NCT00048568|Secondary|Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, Discontinuation Due to SAEs, AEs, Related AEs, or Discontinued Due to AEs in the DB Period|AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE was defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|Day 1 to Day 365|All treated subjects in the DB period.||Participants|||Number
700539|NCT00048568|Secondary|Mean BL and Disease Activity Score 28 (DAS-28; Erythrocyte Sedimentation Rate [ESR]) at Day 169 and Day 365|The DAS 28 is an assessment of disease activity measured on a visual analog scale (VAS)of 100 mm. The scale reports from 1 to 10, with increasing number indicating increasing extent of disease progression. Scores for disease activity are defined as high (>5.1); low (≤3.2); remission (<2.6). Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 169, Day 365, Day 169, Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last Observation Carried Forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
700857|NCT00045032|Secondary|Percentage of Participants With Distant Tumor Recurrence (DTR) Compared to Observation: 8-Year Median Follow-Up|The percentage of participants with DTR was reported. DTR included distant tumors ignoring local and regional recurrences, contralateral breast cancer, and second non-breast malignancy.|From Baseline until time of event (median of 8 years)|FAS Population||percentage of participants|||Number
700540|NCT00048568|Secondary|Number of Participants Achieving Major Clinical Response By Day 365|A Major Clinical Response (MCR) is defined as maintenance of an ACR 70 response over a continuous 6-month period.|Day 1 to Day 365. Data were collected monthly during the first 6 months and then every other month (with the exception of Day 337) during the second 6 months of the DB period.|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.||Participants|||Number
700541|NCT00048568|Secondary|ACR 70 Responders in the DB Period|ACR 70 response requires a patient to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score.|Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.||Participants|||Number
700542|NCT00048568|Secondary|ACR 70 Responders at Day 365|ACR 70 response requires a patient to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score.|Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.||Participants|||Number
700543|NCT00048568|Secondary|ACR 70 Responders at Day 169|ACR 70 response requires a patient to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score.|Day 169|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.||Participants|||Number
700544|NCT00048568|Secondary|ACR 50 Responders in the DB Period|ACR 50 response requires a patient to have a 50% reduction in the number of swollen and tender joints, and a reduction of 50% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. A participant achieved a sustained ACR 50 response if the participant had ACR 50 observed for at least 2 consecutive study visits.|Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.||Participants|||Number
700545|NCT00048568|Secondary|ACR 50 Responders at Day 365|ACR 50 response requires a patient to have a 50% reduction in the number of swollen and tender joints, and a reduction of 50% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score.|Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.||Participants|||Number
700546|NCT00048568|Secondary|ACR 50 Responders at Day 169|ACR 50 response requires a patient to have a 50% reduction in the number of swollen and tender joints, and a reduction of 50% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. A participant achieved a sustained ACR 50 response if the participant had ACR 50 observed for at least 2 consecutive study visits.|Day 169|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.||Participants|||Number
700547|NCT00048568|Secondary|ACR 20 Responders in the Double-Blind (DB) Period|ACR 20 response requires a patient to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score.|Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.||Participants|||Number
700548|NCT00048568|Secondary|ACR 20 Responders at Day 365|ACR 20 response requires a patient to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. A participant achieved a sustained ACR 20 response if the participant had ACR 20 observed for at least 2 consecutive study visits.|Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.||Participants|||Number
700549|NCT00048568|Secondary|BL Rheumatoid Factor (RF) Status for Participants Continuing in the OL Period|This analysis determined whether participants in the OL period were RF positive or RF negative based on serum samples. A positive value for RF was > 20 IU/ml; a negative value for RF was ≤ 20 IU/mL.|BL (Day 365)|All treated participants in the OL period (treatment groups represent treatment received in the DB period).||Participants|||Number
700669|NCT00049127|Secondary|Percentage of Patients Progression-free|"The percentage of patient progression-free at 12 months, 18 months, and PFS will be estimated. Kaplan-Meier survival curves and logrank tests will be used to estimate progression-time distributions.
Progression is defined using response criteria (the neurologic examination and the MRI and/or CT), >25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions."|Time from study registration to date of disease progression or last follow-up, assessed up to 5 years|||months||95% Confidence Interval|Mean
700550|NCT00048568|Secondary|Mean DB BL Participant Physical Pain Assessment, Participant Global Assessment, and Physician Global Assessment|Participant physical pain assessment was determined at baseline on the Visual Analog Scale (VAS) of 0 mm to 100 mm where 0mm is no pain and 100mm is worst pain possible. The mean participant global assessment is a measure of overall disease burden and is a component of the ACR and evaluated using the VAS 100 mm. The physician global assessment is a measure of overall disease burden and is a component of the ACR and evaluated using the VAS 0mm to 100 mm with 0mm indicating no disease burden and 100mm indicating worse disease burden possible.|BL (Day 0)|All randomized and treated participants in the DB period.||Units on a Scale||Standard Deviation|Mean
700551|NCT00048568|Secondary|Mean Number of Tender Joints and Swollen Joints at DB BL||BL (Day 0)|All randomized and treated participants in the DB period.||Joints||Standard Deviation|Mean
700552|NCT00048568|Primary|Baseline and Mean Change From Baseline (BL) in Radiographic Erosion Score Results at Day 365|To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions. The erosion score range is 0 (no radiographic damage) to 145 (worst possible radiographic damage). Change from baseline = Post-baseline - Baseline value|BL (Day 0), Day 365|All randomized and treated participants in the DB period with radiographic data available at baseline and Day 365. Due to the compliance issues of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.||Units on a Scale||Standard Deviation|Mean
700553|NCT00048568|Primary|Number of Participants Achieving Clinically Meaningful Improvement in Health Assessment Questionnaire (HAQ) at Day 365|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.||Participants|||Number
700554|NCT00048568|Primary|Number of American College of Rheumatology 20 (ACR 20) Responders at Day 169|ACR 20 response requires a patient to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in Health Assessment Questionnaire (HAQ) score. A participant achieved a sustained ACR 20 response if the participant had ACR 20 observed for at least 2 consecutive study visits.|Day 169|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.||Participants|||Number
700555|NCT00048581|Secondary|Cumulative Analysis (DB + OL); Number of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Responses by Enzyme-Linked Immunosorbent Assay (ELISA)|Serum samples from all treated adult participants with active rheumatoid arthritis (RA) were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.|From BL (Day 1) to Day 1821|All participants treated on study with at least one post-baseline immunogenicity measurement.||participants|||Number
700556|NCT00048581|Secondary|OL; Mean Change From Baseline in Activity Limitation Score Over Time For Participants Treated in the OL|Limitations on activities of daily living in the OL period at each study visit was measured by a 2-item questionnaire that was developed to collect data on the amount of time that a participant is unable to perform their usual activities because of their rheumatoid arthritis. The scale ranges from 0 to 100 with increasing score indicating increasing restrictions on levels of activity.|Days 169, 365, 729, 1093, 1457, and 1821|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||units on a scale||Standard Error|Mean
700557|NCT00048581|Secondary|OL; Mean Time-matched Baseline Activity Limitation Score Over Time For Participants Treated in the OL|Limitations on activities of daily living in the OL period at each study visit were measured by a 2-item questionnaire that was developed to collect data on the amount of time that a participant is unable to perform their usual activities because of their rheumatoid arthritis. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit. The scale ranges from 0 to 100 with increasing score indicating increasing restrictions on levels of activity.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||units on a scale||Standard Deviation|Mean
700558|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in Fatigue VAS Over Time For Participants Treated in the OL|Fatigue severity was assessed on the VAS 100 mm where 0= no fatigue to 100 = the worst fatigue imaginable. Change from BL = Post-BL value – time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.|BL, Days 169, 365, 729, 1093, 1457, and 1821|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug.||units on a scale||Standard Error|Mean
700559|NCT00048581|Secondary|OL; Mean Time-matched Baseline Fatigue Visual Analog Score (VAS) Over Time For Participants Treated in the OL|Fatigue severity was assessed on the VAS 100 mm where 0= no fatigue to 100 = the worst fatigue imaginable. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||units on a scale||Standard Deviation|Mean
700560|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in MOS-Sleep Score Over Time For Participants Treated in the OL|The validated 12-it3em Medical Outcomes Study sleep questionnaire (MOS-sleep) was used to measure sleep quality. An overall Sleep Problem Index (SPI) was generated as a summary measure of different types of sleep problems (sleep disturbance, sleep quantity, sleep adequacy, etc.). The score ranges from 0 to 100 with a higher score reflecting more severe problems with sleep. Change from BL = Post-BL value – time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.|BL, Days 169, 365, 729, 1093, 1457, and 1821|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug.||units on a scale||Standard Error|Mean
700561|NCT00048581|Secondary|OL; Mean Time-matched Baseline Medical Outcomes Study Sleep Module (MOS-sleep) Score Over Time For Participants Treated in the OL|The validated 12-it3em Medical Outcomes Study sleep questionnaire (MOS-sleep) was used to measure sleep quality. An overall Sleep Problem Index (SPI) was generated as a summary measure of different types of sleep problems (sleep disturbance, sleep quantity, sleep adequacy, etc.). The score ranges from 0 to 100 with a higher score reflecting more severe problems with sleep. The mean score of the SPI in a population with chronic problems is 29.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||units on a scale||Standard Deviation|Mean
700562|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in Mental Health Score Over Time For Participants Treated in the OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from BL = Post-BL value – time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.|BL, Days 169, 365, 729, 1093, 1457, and 1821|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||units on a scale||Standard Error|Mean
700563|NCT00048581|Secondary|OL; Mean Time-matched Baseline Mental Health Score Over Time For Participants Treated in the OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores:PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||units on a scale||Standard Deviation|Mean
700564|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in Role-Emotional Score Over Time For Participants Treated in the OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from BL = Post-BL value – time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.|BL, Days 169, 365, 729, 1093, 1457, and 1821|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||units on a scale||Standard Error|Mean
700565|NCT00048581|Secondary|OL; Mean Time-matched Baseline Role-Emotional Score Over Time For Participants Treated in the OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores:PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||units on a scale||Standard Deviation|Mean
700566|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in Social Functioning Score Over Time For Participants Treated in the OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from BL = Post-BL value – time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.|BL, Days 169, 365, 729, 1093, 1457, and 1821|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||units on a scale||Standard Error|Mean
700567|NCT00048581|Secondary|OL; Mean Time-matched Baseline Social Functioning Score Over Time For Participants Treated in the OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores:PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||units on a scale||Standard Deviation|Mean
700568|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in Vitality Score Over Time For Participants Treated in the OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from BL = Post-BL value – time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.|BL, Days 169, 365, 729, 1093, 1457, and 1821|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||units on a scale||Standard Error|Mean
700569|NCT00048581|Secondary|OL; Mean Time-matched Baseline Vitality Score Over Time For Participants Treated in the OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores:PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||units on a scale||Standard Deviation|Mean
700570|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in General Health Score Over Time For Participants Treated in the OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from BL = Post-BL value – time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.|BL, Days 169, 365, 729, 1093, 1457, and 1821|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||units on a scale||Standard Error|Mean
700571|NCT00048581|Secondary|OL; Mean Time-matched Baseline General Health Score Over Time For Participants Treated in the OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores:PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||units on a scale||Standard Deviation|Mean
700572|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in Bodily Pain Score Over Time For Participants Treated in the OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from BL = Post-BL value – time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.|BL, Days 169, 365, 729, 1093, 1457, and 1821|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||units on a scale||Standard Error|Mean
700587|NCT00048581|Secondary|OL; Mean Time-matched Baseline Levels of Rheumatoid Factor (RF) Over Time For Participants Treated in the OL|RF is an autoantibody most relevant in rheumatoid arthritis. It is an antibody against the Fc portion of Immunoglobulin (Ig)G, which is itself an antibody. RF and IgG join to form immune complexes which contribute to the disease process. Time-matched baseline levels of RF were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||IU/ml||Standard Deviation|Mean
700573|NCT00048581|Secondary|OL; Mean Time-matched Baseline Bodily Pain Score Over Time For Participants Treated in the OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores:PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||units on a scale||Standard Deviation|Mean
700574|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in Role-Physical Score Over Time For Participants Treated in the OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from BL = Post-BL value – time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.|BL, Days 169, 365, 729, 1093, 1457, and 1821|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||units on a scale||Standard Error|Mean
700575|NCT00048581|Secondary|OL; Mean Time-matched Baseline Role-Physical Score Over Time For Participants Treated in the OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores:PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||units on a scale||Standard Deviation|Mean
700576|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in Physical Function Score Over Time For Participants Treated in the OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from BL = Post-BL value – time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.|BL, Days 169, 365, 729, 1093, 1457, and 1821|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||units on a scale||Standard Error|Mean
700577|NCT00048581|Secondary|OL; Mean Time-matched Baseline Physical Function Score Over Time For Participants Treated in the OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores:PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||units on a scale||Standard Deviation|Mean
700578|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in SF-36 PCS and MCS Over Time For Participants Treated in OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from BL = Post-BL value – time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.|BL, Days 169, 365, 729, 1093, 1457, and 1821|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||units on a scale||Standard Error|Mean
700603|NCT00048581|Primary|Open-Label Period (OL); Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, or AEs Leading to Discontinuation|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.Related AE/SAE=Certain,Probable,Possible,or Missing relationship to Drug|From first day of OL to 5.5 years|All treated participants||participants|||Number
700579|NCT00048581|Secondary|OL; Mean Time-matched Baseline SF-36 PCS and MCS Over Time For Participants Treated in OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores:PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||units on a scale||Standard Deviation|Mean
700580|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in Levels of sIL-2R Over Time For Participants Treated in the OL|IL-2 is a proinflammatory cytokine, and the soluble form of its receptor (IL-2R) is a marker for inflammation. Change from BL = Post-BL value – time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.|BL, Days 169, 365, 729, 1093, 1261, 1457, and 1821|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||pg/ml||Standard Error|Mean
700581|NCT00048581|Secondary|OL; Mean Time-matched Baseline Levels of Soluble Interleukin 2 Receptor (sIL-2R) Over Time For Participants Treated in the OL|IL-2 is a proinflammatory cytokine, and the soluble form of its receptor (IL-2R) is a marker for inflammation. Time-matched baseline levels of IL-2R were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||pg/ml||Standard Deviation|Mean
700582|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in ESR Over Time For Participants Treated in the OL|ESR, also called a sedimentation rate or Biernacki Reaction, is the rate at which red blood cells sediment in a period of 1 hour. It is a common hematology test that is a non-specific measure of inflammation. Change from BL = Post-BL value – time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.|BL, Days 169, 365, 729, 1093, 1261, 1457, and 1821|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||mm/hr||Standard Error|Mean
700583|NCT00048581|Secondary|OL; Mean Time-matched Baseline Erythrocyte Sedimentation Rate (ESR) Over Time For Participants Treated in the OL|ESR, also called a sedimentation rate or Biernacki Reaction, is the rate at which red blood cells sediment in a period of 1 hour. It is a common hematology test that is a non-specific measure of inflammation. Time-matched baseline levels of ESR were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||mm/hr||Standard Deviation|Mean
700584|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in Levels of CRP Over Time For Participants Treated in the OL|CRP is an acute phase reactant protein that is a clinical marker for RA. Change from BL = Post-BL value – time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.|BL, Days 169, 365, 729, 1093, 1261, 1457, and 1821|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||mg/dL||Standard Error|Mean
700585|NCT00048581|Secondary|OL; Mean Time-matched Baseline Levels of C-Reactive Protein (CRP) Over Time For Participants Treated in the OL|CRP is an acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA). Time-matched baseline levels of CRP were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||mg/dL||Standard Deviation|Mean
700586|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in Levels of RF Over Time For Participants Treated in the OL|RF is an autoantibody most relevant in rheumatoid arthritis. It is an antibody against the Fc portion of Immunoglobulin (Ig)G, which is itself an antibody. RF and IgG join to form immune complexes which contribute to the disease process. Change from BL = Post-BL value – time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.|BL, Days 169, 365, 729, 1093, 1261, 1457, and 1821|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||IU/ml||Standard Error|Mean
700687|NCT00049530|Secondary|Overall Survival|Overall survival (OS) time was defined as the time from registration to death from any cause, or censored at last known date of survival.|assessed every 3 months if <2 years, and every 6 months if 2-3 years|eligible and treated||months||95% Confidence Interval|Median
725994|NCT00358826|Secondary|Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) - Core Study||Baseline and 12 weeks|Evaluable Population||mg/L||Inter-Quartile Range|Median
700588|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in HAQ-DI and HAQ Component Scores For Participants Treated in the OL|HAQ-DI is a self-administered questionnaire composed of 20 questions to assess physical functions in 8 domains:dressing, arising, eating, walking, hygiene, reach, grip and common activities. Questions evaluated on a 4-point scale: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. HAQ-DI=weighted sum of the scale scores. Higher score indicates poorer function.Change from BL = Post-BL value – time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit|BL, Days 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1261, 1457, 1625, and 1821|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||units on a scale||Standard Error|Mean
700589|NCT00048581|Secondary|OL; Mean Time-matched Baseline HAQ-DI and HAQ Component Scores Over Time For Participants Treated in the OL|The HAQ DI is a self-administered questionnaire composed of 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. Questions are evaluated on a 4-point scale: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. HAQ-DI is a weighted sum of the scale scores, with a higher score indicating poorer function. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||units on a scale||Standard Error|Mean
700590|NCT00048581|Secondary|OL; Number of Participants Achieving HAQ Response Over Time In Participants Treated in the OL|The HAQ disability index (HAQ DI) is a self-administered questionnaire composed of 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. The HAQ disease index is a weighted sum of the scale scores, with a higher score indicating poorer function. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|Days 15, 29, 57, 85, 113, 141, 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1261, 1457, 1625, and 1821|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants analyzed, n=number of participants with measurements at visit.||participants|||Number
700591|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in DAS28 (ESR) Over Time For Participants Treated in the OL|DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). Time-matched mean change from baseline = Post-baseline value - time-matched baseline value, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with data available at that visit.|BL, Days 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1261, 1457, 1625, and 1821|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||units on a scale||Standard Error|Mean
700592|NCT00048581|Secondary|OL; Mean Time-matched Baseline DAS28 (ESR) Over Time For Participants Treated in the OL|The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP levels, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||units on a scale||Standard Deviation|Mean
700593|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in DAS28 (CRP) Over Time For Participants Treated in the OL|DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). Time-matched mean change from baseline = Post-baseline value - time-matched baseline value, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with data available at that visit.|BL, Days 15, 29, 57, 85, 113, 141, 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1261, 1457, 1625, and 1821|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||units on a scale||Standard Error|Mean
700604|NCT00048581|Secondary|DB; Number of Participants With Blood Chemistry Laboratories Meeting MA Criteria|Marked abnormality criteria: Alkaline phosphatase (ALP): >2* ULN, or if BL>ULN then use >3* BL; aspartate aminotransferase (AST): >3* ULN, or if BL>ULN then use >4* BL; alanine aminotransferase (ALT): >3* ULN, or if BL>ULN then use >4* BL; G-Glutamyl transferase (GGT): >2* ULN, or if BL>ULN then use >3* BL; Bilirubin: >2* ULN, or if BL>ULN then use >4* BL; blood urea nitrogen (BUN): >2* BL; creatinine: >1.5* BL|From BL up to database lock for DB period (6/2/2004)|All treated participants||participants|||Number
700594|NCT00048581|Secondary|OL; Mean Time-matched Baseline DAS28 (CRP) Over Time For Participants Treated in the OL|The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP levels, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||units on a scale||Standard Deviation|Mean
700595|NCT00048581|Secondary|OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL|The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). A clinically significant response= decrease in DAS28 score of >1.2 from baseline.|Days 15, 29, 57, 85, 113, 141, 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1261, 1457, 1625, and 1821|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit||participants|||Number
700596|NCT00048581|Secondary|OL; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time For Participants Treated in the OL|ACR 20/50/70 response requires a participant to have a 20/50/70% reduction in the number of swollen and tender joints, and a reduction of 20/50/70% in three of the following five parameters: physician global assessment of disease, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in Health Assessment Questionnaire (HAQ) score. A participant achieved a sustained ACR 20/50/70 response if the participant had ACR 20/50/70 observed for at least 2 consecutive study visits.|Days 15, 29, 57, 85, 113, 141, 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1261, 1457, 1625, and 1821|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit||participants|||Number
700597|NCT00048581|Primary|OL; Mean Time-matched Change From Baseline in Immunoglobulin (Ig) Levels Over the OL|Serum samples collected from participants were used to determine serum levels of IgA, IgM, and IgG. Time-matched mean change from baseline = Post-baseline value - time-matched baseline value, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with serum samples available at that visit.|BL, Days 169, 365, 729, and 1093|All treated participants with available serum samples. N=the total number of participants analyzed, n=the number of participants at that time point with available serum samples. Mean time-matched baseline values reflect changing n-values over time.||mg/dL||Standard Error|Mean
700598|NCT00048581|Primary|OL; Mean Time-matched Baseline Immunoglobulin (Ig) Levels Over the OL|Serum samples collected from participants were used to determine serum levels of IgA, IgM, and IgG. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with serum samples available at that visit.|Baseline and Days 169, 365, 729, and 1093|All treated participants with available serum samples. N=the total number of participants analyzed, n=the number of participants at that time point with available serum samples. Mean time-matched baseline values reflect changing n-values over time.||mg/dL||Standard Deviation|Mean
700599|NCT00048581|Primary|OL; Number of Participants With Blood Chemistry Laboratories Meeting Marked Abnormality Criteria|Marked abnormality criteria: Alkaline phosphatase (ALP): >2* ULN, or if BL>ULN then use >3* BL; aspartate aminotransferase (AST): >3* ULN, or if BL>ULN then use >4* BL; alanine aminotransferase (ALT): >3* ULN, or if BL>ULN then use >4* BL; G-Glutamyl transferase (GGT): >2* ULN, or if BL>ULN then use >3* BL; Bilirubin: >2* ULN, or if BL>ULN then use >4* BL; blood urea nitrogen (BUN): >2* BL; creatinine: >1.5* BL|From first day of OL to 5.5 years|All treated participants||participants|||Number
700600|NCT00048581|Primary|OL; Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria|Upper Normal Limit (ULN), Lower Normal Limit (LLN), Baseline (BL). Marked abnormality criteria are: Hemoglobin (HGB): >3 g/dL decrease from BL; Hematocrit: <0.75 * BL; Erythrocytes: <0.75 * BL; Platelets (PLT): <0.67 * LLN/>1.5 * ULN, or if BL < LLN then use 0.5 * BL/<100,000 mm^3; Leukocytes: <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL/>ULN, or if BL>ULN then use >1.2 * BL/<LLN; neutrophils+bands: <1.0 * 10^3 c/uL; eosinophils: >0.750 * 10^3 c/uL; basophils: > 400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750 * 10^3 c/uL/ >7.50 * 10^3 c/uL.|From first day of OL to 5.5 years|All treated participants||participants|||Number
700601|NCT00048581|Primary|OL; Number of Participants AEs of Special Interest|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).|From first day of OL to 5.5 years|All treated participants||participants|||Number
700602|NCT00048581|Secondary|DB; Number of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Responses by Enzyme-Linked Immunosorbant Assay (ELISA)|Serum samples from all treated adult participants with active rheumatoid arthritis (RA) were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.|From BL to Day 169|All treated participants in the double-blind period with at least 1 post-baseline immunogenicity result||participants|||Number
700730|NCT00039130|Primary|Complete Response Rate|Response is assessed by investigator according to Revised Response Criteria for Malignant Lymphoma. Complete response requires disappearance of all evidence of disease.|6 months|||percentage of participants||95% Confidence Interval|Number
700605|NCT00048581|Secondary|DB; Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria|Upper Normal Limit (ULN), Lower Normal Limit (LLN), Baseline (BL). Marked abnormality criteria are: Hemoglobin (HGB): >3 g/dL decrease from BL; Hematocrit: <0.75 * BL; Erythrocytes: <0.75 * BL; Platelets (PLT): <0.67 * LLN/>1.5 * ULN, or if BL < LLN then use 0.5 * BL/<100,000 mm^3; Leukocytes: <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL/>ULN, or if BL>ULN then use >1.2 * BL/<LLN; neutrophils+bands: <1.0 * 10^3 c/uL; eosinophils: >0.750 * 10^3 c/uL; basophils: > 400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750 * 10^3 c/uL/ >7.50 * 10^3 c/uL.|From BL up to database lock for DB period (6/2/2004)|All treated participants||participants|||Number
700606|NCT00048581|Secondary|DB; Number of Participants AEs of Special Interest|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).|From BL up to database lock for DB period (6/2/2004)|All treated participants||participants|||Number
700607|NCT00048581|Secondary|DB; Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, or AEs Leading to Discontinuation|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.Related AE/SAE=Certain,Probable,Possible,or Missing relationship to Drug|From BL up to database lock for DB period (6/2/2004)|All treated participants||participants|||Number
700608|NCT00048581|Secondary|DB; Adjusted Mean Change From Baseline to Day 169 in DAS28 (CRP) and DAS28 (ESR)|The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). Change from BL = Post-BL value – time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at Day 169.|BL, Day 169|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit||Units on a Scale||Standard Error|Mean
700609|NCT00048581|Secondary|DB; Mean Disease Activity Score (DAS)28 (C-Reactive Protein [CRP]) and Mean Disease Activity Score (Erythrocyte Sedimentation Rate [ESR]) at Day 169|The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP levels, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). A clinically significant response= decrease in DAS28 score of >1.2 from baseline. The mean BL value presented represents a time-matched Day 169 BL value for only that cohort of participants with assessments available at that visit.|BL, Day 169|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit||Units on a Scale||Standard Deviation|Mean
700610|NCT00048581|Secondary|DB; Adjusted Mean Change From Baseline to Day 169 in HAQ-DI and HAQ Component Scores in Participants With Assessments at Day 169|HAQ DI is a self-administered questionnaire composed of 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. Questions evaluated on a 4-point scale: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. HAQ-DI=weighted sum of the scale scores. Higher score indicates poorer function.Change from BL = Post-BL value – time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at Day 169.|BL, Day 169|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit||units on a scale||Standard Deviation|Mean
700611|NCT00048581|Secondary|DB; Mean Baseline HAQ-DI and HAQ Component Scores in Participants With Assessments at Day 169|The HAQ DI is a self-administered questionnaire composed of 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. Questions are evaluated on a 4-point scale: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. HAQ-DI is a weighted sum of the scale scores, with a higher score indicating poorer function. The mean baseline value presented represents a time-matched Day 169 baseline value for only that cohort of participants with assessments available at that visit.|BL|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit||units on a scale||Standard Deviation|Mean
700619|NCT00048581|Secondary|DB; Mean Change From Baseline to Day 169 in Levels of Disease Biomarkers (IL-6, sIL-2R, and TNF-alpha) in Participants With Measurements at Day 169|The mean change from baseline in levels of potential biomarkers of disease (IL-6, SIL-2R, and TNF-Alpha) were determined from serum samples for all participants. Change from Baseline = Post-baseline value – time-matched baseline value, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with data available at Day 169.|BL, Day 169|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit||pg/ml||Standard Error|Mean
700612|NCT00048581|Secondary|DB; Adjusted Mean Change From Baseline to Day 169 in SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participants With Measurements at Day 169|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from Baseline= Post-baseline value – time-matched baseline value, where time-matched BL value = the mean BL value for only that cohort of participants with data available at Day 169.|BL, Day 169|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit||Units on a Scale||Standard Deviation|Mean
700613|NCT00048581|Secondary|DB; Mean Baseline SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participants With Measurements at Day 169|SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Mean BL value presented represents a time-matched Day 169 BL value for only that cohort of participants with data available at that visit.|BL|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit||Units on a Scale||Standard Deviation|Mean
700614|NCT00048581|Secondary|DB; Adjusted Mean Change From Baseline to Day 85 in Short SF-36 PCS, MCS, and SF-36 Individual Component Scores|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from Baseline= Post-baseline value – time-matched baseline value, where time-matched BL value = the mean BL value for only that cohort of participants with data available at Day 85.|BL, Day 85|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit||Units on a Scale||Standard Error|Mean
700615|NCT00048581|Secondary|DB; Mean Baseline Short Form 36 (SF-36) Quality of Life Physical Component Summary (PCS), Mental Component Summary (MCS), and SF-36 Individual Component Scores For Participants With Measurements at Day 85|SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Mean BL value presented represents a time-matched Day 85 BL value for only that cohort of participants with data available at that visit.|BL|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit||Units on a Scale||Standard Deviation|Mean
700616|NCT00048581|Secondary|DB; Mean Change From Baseline to Day 169 in Rheumatoid Factor (RF) Status|Rheumatoid factor (RF or RhF) is an autoantibody (antibody directed against an organism's own tissues) most relevant in rheumatoid arthritis. It is an antibody against the Fc portion of Immunoglobulin (Ig)G, which is itself an antibody. RF and IgG join to form immune complexes which contribute to the disease process. A positive value for RF was >20 IU/mL; a negative value for RF was ≤ 20 IU/mL.|BL, Day 169|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit||participants|||Number
700617|NCT00048581|Secondary|DB; Mean Change From Baseline to Day 169 in Levels of Disease Biomarkers (E-Selectin, sICAM-1, and MMP-3) in Participants With Measurements at Day 169|Potential biomarkers of disease (E-selectin, sICAM-1, and MMP-3) were determined from serum samples for all participants. Change from Baseline = Post-baseline value – time-matched baseline value, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with data available at Day 169.|BL, Day 169|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit||ng/ml||Standard Error|Mean
700618|NCT00048581|Secondary|DB; Mean Baseline Levels of Disease Biomarkers (E-Selectin, Soluble Inter-Cellular Adhesion Molecule 1 [sICAM-1], and Matrix Metalloproteinase-3 [MMP-3]) in Participants With Measurements at Day 169|Potential biomarkers of disease (E-selectin, sICAM-1, and MMP-3) were determined from serum samples for all participants. The mean baseline value presented represents a time-matched Day 169 baseline value for only that cohort of participants with assessments available at that visit.|BL|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit||ng/ml||Standard Deviation|Mean
700643|NCT00048893|Secondary|Number of Months of Progression Free Survival|The time period a participant remains free from progressive disease. Progressive disease (PD) is defined as a greater than 25% increase in the sum of the longest perpendicular dimensions of any measurable disease or the appearance of new disease or an increase in evaluable disease.|After the immune depletion cycle|The study was closed to accrual due to very poor enrollment. No meaningful data analysis was possible on the small number of accrued subjects, so none was done.||Months|||Number
700620|NCT00048581|Secondary|DB; Mean Baseline Levels of Disease Biomarkers (Interleukin-6 (IL-6), Soluble IL-2 Receptor [sIL-2R], and Tumor Necrosing Factor [TNF]-Alpha) in Participants With Measurements at Day 169|Potential biomarkers of disease (IL-6, SIL-2R, and TNF-Alpha) were determined from serum samples for all participants. The mean baseline value presented represents a time-matched Day 169 baseline value for only that cohort of participants with assessments available at that visit.|BL|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit||pg/ml||Standard Deviation|Mean
700621|NCT00048581|Secondary|DB; Mean Time-Matched Percentage of Change From Baseline in CRP Levels Over Time: ACR Core Component|CRP is an acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA) and a core component of the ACR scoring system. CRP was evaluated from serum samples. Increasing levels indicate increasing level of disease. Mean Time-matched percentage of change from baseline = (time-matched baseline value - Post-baseline value)/time-matched baseline value x 100, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with data available at that visit.|Days 15, 29, 57, 85, 113, 141, and 169|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||percentage of change from BL||Standard Error|Mean
700622|NCT00048581|Secondary|DB; Mean Time-matched Baseline C-Reactive Protein (CRP) Levels Over Time: ACR Core Component|CRP is an acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA) and a core component of the ACR scoring system. CRP was evaluated from serum samples. Increasing levels of CRP indicate increasing level of disease. For each post-baseline visit in the DB, time-matched baseline CRP values were presented and represent the mean baseline value for only that cohort of participants with assessments available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||mg/dL||Standard Deviation|Mean
700623|NCT00048581|Secondary|DB; Mean Time-Matched Percentage of Change From Baseline in Physician Global Assessment Over Time: ACR Core Component|Physician global rheumatoid arthritis (RA) assessment core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100mm Visual Analog Scale (VAS) with 0mm representing no pain and 100mm representing the most pain possible. Mean Time-matched percentage of change from baseline = (time-matched baseline value - Post-baseline value)/time-matched baseline value x 100, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with assessments available at that visit.|BL, Days 15, 29, 57, 85, 113, 141, and 169|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||percentage of change from BL||Standard Error|Mean
700624|NCT00048581|Secondary|DB; Mean Time-matched Baseline Physician Global Assessment Over Time: ACR Core Component|Physician global rheumatoid arthritis (RA) assessment core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100mm Visual Analog Scale (VAS) with 0mm representing no pain and 100mm representing the most pain possible. For each post-baseline visit in the DB, time-matched baseline Physician Global Assessment values were presented and represent the mean baseline value for only that cohort of participants with assessments available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||units on a scale||Standard Deviation|Mean
700625|NCT00048581|Secondary|DB; Mean Time-Matched Percentage of Change From Baseline in Participant Global Assessment Over Time: ACR Core Component|Participant self-reported global RA assessment core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100mm Visual Analog Scale (VAS) with 0mm representing no pain and 100mm representing the most pain possible. Mean Time-matched percentage of change from baseline = (time-matched baseline value - Post-baseline value)/time-matched baseline value x 100, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with assessments available at that visit.|BL, Days 15, 29, 57, 85, 113, 141, and 169|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||percentage of change from BL||Standard Error|Mean
700626|NCT00048581|Secondary|DB; Mean Time-matched Baseline Participant Global Assessment Over Time: ACR Core Component|Participant self-reported global RA assessment core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100 mm Visual Analog Scale (VAS) with 0 mm representing no pain and 100 mm representing the most pain possible. For each post-baseline visit in the DB, time-matched baseline Participant Global Assessment values were presented and represent the mean baseline value for only that cohort of participants with assessments available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||units on a scale||Standard Deviation|Mean
700644|NCT00048893|Secondary|Immune Response to the Vaccine in Those Patients With Late Recovery of Thymic Function|It is expected that delayed administration of a vaccine will result in enhancement of immune response to the vaccine in those patients with later recovery of thymic function as evidenced by change in lymphocyte subsets in the blood.|2 years|The study was closed to accrual due to very poor enrollment. No meaningful data analysis was possible on the small number of accrued subjects, so none was done.||Cells/L|||Number
700627|NCT00048581|Secondary|DB; Mean Time-Matched Percentage of Change From Baseline in HAQ-DI Over Time: ACR Core Component|A self-administered questionnaire with 20 questions assessing physical function in 8 domains:dressing,arising,eating,walking,hygiene,reach,grip and common activities.Questions evaluated on a 4-point scale:0=without any difficulty,1=with some difficulty,2=with much difficulty,and 3=unable to do. HAQ-DI=weighted sum of scale scores, with higher scores indicating poorer function. Mean time-matched % change from BL=(time-matched BL value - Post-BL value)/time-matched BL value x100, where time-matched BL value=the mean BL value for only that cohort of participants with data available at that visit.|BL, Days 15, 29, 57, 85, 113, 141, and 169|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||percentage of change from BL||Standard Error|Mean
700628|NCT00048581|Secondary|DB; Mean Time-matched Baseline HAQ-DI Over Time: ACR Core Component|HAQ-DI is a self-administered questionnaire composed of 20 questions assessing physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. Questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The HAQ-DI is the weighted sum of the scale scores, with higher scores indicating poorer function. For each post-BL visit, time-matched BL HAQ-DI values were presented and represent the mean BL value for only that cohort of participants with data available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||units on a scale||Standard Deviation|Mean
700629|NCT00048581|Secondary|DB; Mean Time-Matched Percentage of Change From Baseline in Participant Pain Assessment Over Time: ACR Core Component|Participant self-reported pain assessment is a core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100 mm Visual Analog Scale (VAS) with 0 mm representing no pain and 100 mm representing the most pain possible. Mean Time-matched percentage of change from baseline = (time-matched baseline value - Post-baseline value)/time-matched baseline value x 100, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with assessments available at that visit.|BL, Days 15, 29, 57, 85, 113, 141, and 169|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||percentage of change from BL||Standard Error|Mean
700630|NCT00048581|Secondary|DB; Mean Time-matched Baseline Participant Pain Assessment Over Time: ACR Core Component|The participant self-reported pain assessment is a core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100 mm Visual Analog Scale (VAS) with 0 mm representing no pain and 100 mm representing the most pain possible. For each post-baseline visit in the DB, time-matched baseline Participant Pain Assessment values were presented and represent the mean baseline value for only that cohort of participants with assessments available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||units on a scale||Standard Deviation|Mean
700631|NCT00048581|Secondary|DB; Mean Time-Matched Percentage of Change From Baseline in SJC Over Time: ACR Core Component|The mean SJC core component of the ACR scoring system was evaluated based on the number of swollen joints in a standard 66 joint count, where an increasing number of swollen joints indicate increasing level of severity. Mean Time-matched percentage of change from baseline = (time-matched baseline value - Post-baseline value)/time-matched baseline value x 100, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with TJCs available at that visit.|Days 15, 29, 57, 85, 113, 141, and 169|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with SJCs. Mean time-matched BL values reflect changing n-values over time.||percentage of change from BL||Standard Error|Mean
700632|NCT00048581|Secondary|DB; Mean Time-matched Baseline Swollen Joint Count (SJC) and Post-Baseline SJCs Over Time: ACR Core Component|The mean SJC core component of the ACR scoring system was evaluated based on the number of swollen joints in a standard 66 joint count, where an increasing number of swollen joints indicates increasing level of severity. Time-matched baseline SJC values for each post-baseline SJC in the DB were presented for each visit and represent the mean baseline SJC value for only that cohort of participants with SJCs available at that visit.|Days 15, 29, 57, 85, 113, 141, and 169|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with SJCs. Mean time-matched BL values reflect changing n-values over time.||swollen joints||Standard Deviation|Mean
700633|NCT00048581|Secondary|DB; Mean Time-Matched Percentage of Change From Baseline in TJC Over Time: ACR Core Component|The mean TJC core component of the ACR scoring system was evaluated based on the number of tender joints in a standard 68 joint count, where an increasing number of tender joints indicates increasing level of severity. Mean Time-matched percentage of change from baseline = (time-matched baseline value - Post-baseline value)/time-matched baseline value x 100, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with TJCs available at that visit.|BL, Days 15, 29, 57, 85, 113, 141, and 169|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with TJCs. Mean time-matched BL values reflect changing n-values over time.||percentage of change from BL||Standard Error|Mean
700731|NCT00039195|Primary|Progression Free Survival|Kaplan-Meier estimates will be used to verify the progression free survival.|2 years|||percentage of patients progression free||95% Confidence Interval|Number
700634|NCT00048581|Secondary|DB; Mean Time-matched Baseline Tender Joint Counts (TJCs) and Post-Baseline TJCs Over Time: ACR Core Component|The mean TJC core component of the ACR scoring system was evaluated based on the number of tender joints in a standard 68 joint count, where an increasing number of tender joints indicates increasing level of severity. Time-matched baseline TJC values for each post-baseline TJC in the DB were presented for each visit and represent the mean baseline TJC value for only that cohort of participants with TJCs available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with TJCs. Mean time-matched BL values reflect changing n-values over time.||tender joints||Standard Deviation|Mean
700635|NCT00048581|Secondary|DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time|ACR 20/50/70 response requires a participant to have a 20/50/70% reduction in the number of swollen and tender joints, and a reduction of 20/50/70% in three of the following five parameters: physician global assessment of disease, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in Health Assessment Questionnaire (HAQ) score. A participant achieved a sustained ACR 20/50/70 response if the participant had ACR 20/50/70 observed for at least 2 consecutive study visits.|Days 15, 29, 57, 85, 113, 141, and 169|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit||participants|||Number
700636|NCT00048581|Primary|DB; Number of Participants Achieving Clinically Meaningful Improvement in Health Assessment Questionnaire (HAQ)|The disability section of the full HAQ includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Higher scores= greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ disability Index.|Day 169|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug.||participants|||Number
700637|NCT00048581|Primary|Double-blind Period (DB); Number of Participants With American College of Rheumatology (ACR) 20 Response at Day 169|ACR 20 response requires a participant to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in Health Assessment Questionnaire (HAQ) score. A participant achieved a sustained ACR 20 response if the participant had ACR 20 observed for at least 2 consecutive study visits.|Day 169|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized participants who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug.||participants|||Number
700638|NCT00048724|Secondary|Time to Observation of the Disease Progression Experienced by a Subject|Disease progression was observation of any clinical event defined for the primary outcome, plus any of development of Child-Pugh Class B, emergence of varices, or enlargement of pre-existing varices requiring additional therapy.|Up to 60 months of treatment or observation, or when 98 subjects experience at least one clinical event|Analysis population is modified intent to treat (MITT), comprising all randomized subjects from sites compliant with GCP (Good Clinical Practice). Two sites were closed due to GCP noncompliance, and the 5 subjects from these sites were excluded from efficacy analyses.||Participants|||Number
700639|NCT00048724|Primary|Time to Observation of the First Clinical Event Experienced by a Subject|Clinical events are liver decompensation [variceal bleeding, development of Child-Pugh Class C, hepatic encephalopathy ≥Grade 2, ascites], hepatic carcinoma, death, and/or liver transplantation|Up to 60 months of treatment or observation, or when 98 subjects experience at least one clinical event|Analysis population is modified intent to treat (MITT), comprising all randomized subjects from sites compliant with GCP (Good Clinical Practice). Two sites were closed due to GCP noncompliance, and the 5 subjects from these sites were excluded from efficacy analyses.||Participants|||Number
700640|NCT00048737|Primary|Number of Participants With Graft Failure|Graft failure is defined as either lack of hematologic recovery or lack of or loss of detectable donor cells.|100 days|||participants|||Number
700641|NCT00048893|Secondary|Number of Participants With a Clinical Response|Defined as measurable disease (any solid lesion that can be measured accurately in at least one dimension), evaluable disease (disease not readily measurable but can be clinically assessed), complete response (complete disappearance of all measurable and evaluable disease), partial response (decrease of greater than or equal to 50%), stable disease (any decrease of less than 50% or increase less than 25% in the sum of the longest perpendicular dimensions), or progressive disease (greater than 25% increase in the sum of the longest perpendicular dimensions of any measurable disease).|At the beginning of each cycle of chemotherapy (every 4 weeks)|The study was closed to accrual due to very poor enrollment. No meaningful data analysis was possible on the small number of accrued subjects, so none was done.||Participants|||Number
700642|NCT00048893|Secondary|Number of Participants With an Immune Response as a Result of the Salvage Immunization Schedule|Patients showing disease progression or recurrence at any point after the start of the early immunizations series may continue on study in accordance to the off study criteria and will be receiving monthly rF immunizations for a total of 12 months or until further disease progression meets the off study criteria. Immune response as evidenced by change in lymphocyte subsets in the blood.|6 weeks, than 6, 12, 18, 24, 30, 36 (3y), 42, 48 (4y), 60 and 72 months after completion of immune chemotherapy|The study was closed to accrual due to very poor enrollment. No meaningful data analysis was possible on the small number of accrued subjects, so none was done.||Participants|||Number
700732|NCT00039377|Secondary|5 Year Overall Survival for Autologous & Allogeneic Transplant Groups|Percentage of patients who were alive at 5 years. The 5-year progression free survival was estimated using the Kaplan Meier method.|5 years from registration|Participants who were on autologous or allogeneic transplant arms were analyzed (N=34).||percentage of patients||95% Confidence Interval|Number
700645|NCT00048893|Secondary|Log Change of CD4 CEA-specific Immune Responses and Their Kinetics as a Surrogate Marker for Clinical Anti-tumor Activity of the Vaccines|Response is evaluated by CD4 response to CEA soluble protein. The log change in precursor frequencies will be calculated between values obtained at baseline and five months post immune depletion. By flow cytometry of peripheral blood lymphocyte frequency of potential killer cells directed to the CEA protein.|Baseline and 5 months post immune depletion|The study was closed to accrual due to very poor enrollment. No meaningful data analysis was possible on the small number of accrued subjects, so none was done.||log change of CD4 CEA specific precursor|||Number
700646|NCT00048893|Secondary|Log Change in Precursor Frequency as Measured by Elispot.|The log change in CEA-specific T cell precursor frequency will be calculated between values obtained at baseline and 5 months post immune depletion. A change equal to 1.0 standard deviation (SD) of the log change is significant.|time to progression, response rate: evaluation every 3 months for 3 years, then every 6 months for one year (fourth year), then yearly thereafter until taken off study|The study was closed to accrual due to very poor enrollment. No meaningful data analysis was possible on the small number of accrued subjects, so none was done.||log change in CEA-specific T cell precur|||Number
700647|NCT00048893|Primary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|91 months|||Participants|||Number
700648|NCT00048893|Primary|Event-free Survival as Measured by Clinical Evaluation and Tumor Measurements by Imaging|Complete response (CR) is the complete disappearance of all measurable and evaluable disease. Partial response (PR) is a decrease of greater than or equal to 50% in the sum of the products of the longest perpendicular dimensions of all measurable target lesions. Stable disease (SD) is any decrease of less than 50% or increase less than 25% in the sum of the longest perpendicular dimensions of measurable disease. Progressive disease (PD) is a greater than 25% increase in the sum of the longest perpendicular dimensions of any measurable disease.|time to progression, response rate: evaluation every 3 months for 3 years, then every 6 months for one year (fourth year), then yearly thereafter until taken off study|The study was closed to accrual due to very poor enrollment. No meaningful data analysis was possible on the small number of accrued subjects, so none was done.||Months|||Number
700649|NCT00048932|Secondary|DB; Number of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Responses by ELISA|Serum samples from all treated adult participants with active rheumatoid arthritis were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.|Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337|All DB participants treated on study who received at least 1 dose of abatacept and had antibody samples collected at baseline and at least 1 post-baseline visit. 68 participants were not evaluated for anti-abatacept anti-bodies on study.||participants|||Number
700650|NCT00048932|Primary|OL; Number of Participants With Clinically Significant Physical Examination or Vital Signs Abnormalities|Physical examinations were performed at the discretion of the investigator and included breast examinations for female participants. Vital sign measurements were performed for participants before and after infusion of study medication at each visit and included seated systolic blood pressure, seated diastolic blood pressure, temperature, and heart rate. Abnormalities were determined to be clinically significant by the investigator.|Days 365 to Day 1821|All Treated Population.||participants|||Number
700651|NCT00048932|Primary|OL; Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting Marked Abnormality Criteria|MA criteria: serum glucose (Glu): <65 mg/dL/>220 mg/dL;fasting serum Glu: <0.8* LLN/>1.5*ULN,or if BL<LLN then use 0.8*BL or >ULN,or if BL>ULN then use >2.0*BL or <LLN;total protein: <0.9*LLN/>1.1*ULN,or if BL<LLN then use <0.9*BL or >UNL,or if BL>UNL then use >1.1*BL or <LLN; albumin: <0.9*LLN,or if BL<LLN then use <0.75 BL;uric acid: >1.5*ULN,or if BL>ULN then use >2*BL. Urinalysis (Urine protein,urine Glu,urine blood,leukocyte esterase,Red Blood Cells [RBCs], White Blood Cells [WBCs]):Use ≥2 when BL value missing or when pre-dose=0 or 0.5; use ≥3 when pre-dose=1, use ≥4 when pre-dose=2 or 3|Day 365 to Day 1821, and including data up to 56 days post last dose of double-blind medication|All Treated Population. N=Number of Participants Analyzed, n=number of participants with measurements at time point||participants|||Number
700652|NCT00048932|Primary|OL; Number of Participants With Electrolyte Laboratories Meeting Marked Abnormality Criteria|Marked abnormality criteria: Sodium (Na): <0.95*LLN/ >1.05*ULN, or if BL<LLN then use <0.95* BL or >ULN, or if BL>ULN then use>1.05* BL or <LLN; potassium (K): <0.9* LLN/>1.1*ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; (Cl): <0.9* LLN/>1.1* ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; calcium (Ca): <0.8* LLN/>1.2* ULN, or if BL<LLN then use <0.75* BL or >ULN, or if BL>ULN then use>1.25* BL or <LLN; phosphorous (P): <0.75* LLN/ >1.25* ULN, or if BL<LLN then use 0.67* BL or >ULN, or if BL>ULN then use>1.33* BL or <LLN|Day 365 to Day 1821, and including data up to 56 days post last dose of double-blind medication|All Treated Population. One participant was not evaluated for electrolyte abnormalities.||participants|||Number
700653|NCT00048932|Primary|OL; Number of Participants With Liver Function Laboratories Meeting Marked Abnormality Criteria|Marked abnormality criteria: Alkaline phosphatase (ALP): >2* ULN, or if BL>ULN then use >3* BL; aspartate aminotransferase (AST): >3* ULN, or if BL>ULN then use >4* BL; alanine aminotransferase (ALT): >3* ULN, or if BL>ULN then use >4* BL; G-Glutamyl transferase (GGT): >2* ULN, or if BL>ULN then use >3* BL; Bilirubin: >2* ULN, or if BL>ULN then use >4* BL; blood urea nitrogen (BUN): >2* BL; creatinine: >1.5* BL|Day 365 to Day 1821, and including data up to 56 days post last dose of double-blind medication|All Treated Population. One participant was not evaluated for liver function abnormalities.||participants|||Number
700654|NCT00048932|Primary|OL; Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria|Upper Normal Limit (ULN), Lower Normal Limit (LLN), Baseline (BL). Marked abnormality criteria are: Hemoglobin (HGB): >3 g/dL decrease from BL; Hematocrit: <0.75 * BL; Erythrocytes: <0.75 * BL; Platelets (PLT): <0.67 * LLN/>1.5 * ULN, or if BL < LLN then use <0.5 * BL and <100,000 mm^3; Leukocytes: <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL or >ULN, or if BL>ULN then use >1.2 * BL or <LLN; neutrophils+bands: <1.0 * 10^3 c/uL; eosinophils: >0.750 * 10^3 c/uL; basophils: > 400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750 * 10^3 c/uL/ >7.50 * 10^3 c/uL.|Day 365 to Day 1821, and including data up to 56 days post last dose of double-blind medication|All Treated Population.||participants|||Number
726378|NCT00360828|Secondary|Progression Free Survival|Patients surviving at one year post treatment end|1 year post treatment end|The low accrual rate prevented us from completing the planned analysis.|||||
700655|NCT00048932|Primary|OL; Number of Participants With AEs of Special Interest|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).|Day 365 to Day 1821|All Treated Participants, all participants who received at least 1 dose of study medication||participants|||Number
700656|NCT00048932|Primary|Open Label Period (OL); Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Related AEs, or AEs Leading to Discontinuation|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Related SAE/AE = possibly, probably, or certainly related to study drug|Day 365 to Day 1,821|All Treated Participants||participants|||Number
700657|NCT00048932|Primary|DB; Number of Participants With Clinically Significant Physical Examination or Vital Signs Abnormalities|Physical examinations were performed at the discretion of the investigator and included breast examinations for female participants. Vital sign measurements were performed for participants before and after infusion of study medication at each visit and included seated systolic blood pressure, seated diastolic blood pressure, temperature, and heart rate. Abnormalities were determined to be clinically significant by the investigator.|Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337. Vital signs were measured at these visits before and after study medication infusion.|All Treated Population.||participants|||Number
700658|NCT00048932|Secondary|DB; Number of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Responses by Enzyme-Linked Immunosorbant Assay (ELISA)|Serum samples from all treated adult participants with active rheumatoid arthritis (RA) were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.|Days 1, 29, 57, 85, 113,169, 281, 365|All participants treated during DB who received at least 1 dose of abatacept and had antibody samples collected at baseline and at least 1 post-baseline visit. 561 participants were not evaluated for anti-abatacept anti-bodies during the DB.||participants|||Number
700659|NCT00048932|Primary|DB; Number of Participants With Blood Chemistry Laboratories Meeting Marked Abnormality (MA) Criteria|ULN=upper level of normal; BL=baseline.Marked abnormality criteria: High alkaline phosphatase (ALP): >2* ULN, or if BL>ULN then use >3* BL; high aspartate aminotransferase (AST): >3* ULN (80 U/L), or if BL>ULN then use >4* BL; high alanine aminotransferase (ALT): >3* ULN (34-47 U/L), or if BL>ULN then use >4* BL; high G-Glutamyl transferase (GGT): >2* ULN, or if BL>ULN then use >3* BL; high bilirubin: >2* ULN, or if BL>ULN then use >4* BL; high blood urea nitrogen (BUN): >2* BL; high creatinine: >1.5* BL (ULN 14.6 pg/mg. AST ULN=80 U/L; ALT ULN=34-47 U/L;creatinine ULN=14.6 pg/mg.|Day 1 to Day 365, and including data up to 56 days post last dose of double-blind medication|All Treated Population. Two participants in the ABA group and 3 participants in the PLA group were not evaluated for blood chemistry abnormalities due to data unavailability (missing data).||participants|||Number
700660|NCT00048932|Primary|DB; Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria|Upper Normal Limit (ULN), Lower Normal Limit (LLN), Baseline (BL). Marked abnormality criteria are: Hemoglobin (HGB): >3 g/dL decrease from BL; Hematocrit: <0.75 * BL; Erythrocytes: <0.75 * BL; Platelets (PLT): <0.67 * LLN/>1.5 * ULN, or if BL < LLN then use <0.5 * BL and <100,000 mm^3; Leukocytes: <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL or >ULN, or if BL>ULN then use >1.2 * BL or <LLN; neutrophils+bands: <1.0 * 10^3 c/uL; eosinophils: >0.750 * 10^3 c/uL; basophils: > 400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750 * 10^3 c/uL/ >7.50 * 10^3 c/uL.|Day 1 to Day 365, and including data up to 56 days post last dose of double-blind medication|All Treated Population. One participant in each group was not evaluated for hematology abnormalities due to data unavailability (missing data).||participants|||Number
700661|NCT00048932|Primary|DB; Number of Participants With AEs of Special Interest|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).|Day 1 to Day 365, and including data up to 56 days post last dose of double-blind medication|All Treated Participants, all participants who received at least 1 dose of study medication||participants|||Number
700662|NCT00048932|Primary|Double Blind Period (DB); Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Related AEs, or AEs Leading to Discontinuation|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Related SAE/AE = possibly, probably, or certainly related to study drug|Day 1 to Day 365, and including data up to 56 days post last dose of double-blind medication|All Treated Participants, all participants who received at least 1 dose of study medication||participants|||Number
700663|NCT00048997|Secondary|Impact of PCI on Incidence of CNS Metastases||After all patients have been potentially followed for a minimum of 12 months||||||
700664|NCT00048997|Secondary|Impact of PCI on Quality of Life||After all patients have been potentially followed for a minimum of 12 months||||||
700665|NCT00048997|Secondary|Neuropsychological Impact of Prophylactic Cranial Irradiation (PCI)||After all patients have been potentially followed for a minimum of 12 months||||||
700670|NCT00049127|Secondary|Confirmed Response (i.e., an Objective Status of Complete Response (CR), Partial Response (PR), or Regression (REGR) on 2 Successive Evaluations at Least 4 Weeks Apart After the Start of Study Treatment).|"Complete Response (CR) is defined using response criteria (the neurologic examination and the Magnetic resonance imaging (MRI) and/or Computerized Tomography (CT)), total disappearance of all tumor with patient off corticosteroids or only on adrenal replacement maintenance.
Partial Response (PR) is defined using response criteria (the neurologic examination and the MRI and/or CT), >=50% reduction in product of perpendicular diameters of contrast enhancement or mass with no new lesions with the patient being on stable or decreased steroid dose.
Regression (REGR) is defined using response criteria (the neurologic examination and the MRI and/or CT), unequivocal reduction in size of contrast-enhancement or decrease in mass effect as agreed upon independently by primary physician and quality control physicians; no new lesions. Patient should be on stable or decreased steroid dose."|Up to 5 years|||percentage of confirmed responses|||Number
700671|NCT00049127|Primary|6-month Progression-free Survival (PFS), Defined as a Patient Being Alive and Progression-free 183 Days After the Date of Registration.|"The proportion of successes will be estimated using the Binomial point estimator (number of successes divided by the total number of evaluable patients) and the Binomial 90% confidence interval estimated using the Duffy-Santer algorithm.
Progression is defined using response criteria (the neurologic examination and the MRI and/or CT), >25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions."|6 months|||percentage of patients|||Number
700672|NCT00049257|Secondary|Overall Survival Rate|Complete response:Complete disappearance of all clinically detectable malignant disease for at least 4 weeks.Partial Response:Definite improvement in evaluable disease estimated to be in excess of 50% and agreed upon by 2 investigators. Response must last for at least 4 weeks.Stable disease:No significant change in disease for at least 4 weeks. Includes an estimated decrease of <50% and lesions with an estimated increase of <25%.Progressive disease(PD):Definite increase in area of any malignant lesion estimated to be >=25% or appearance of new lesions. Need for radiotherapy is considered PD.|Assessed every two months after completion of study treatment for 4 years|||participants|||Number
700673|NCT00049257|Secondary|Objective Response Rate|Complete response:Complete disappearance of all clinically detectable malignant disease for at least 4 weeks.Partial Response:Definite improvement in evaluable disease estimated to be in excess of 50% and agreed upon by 2 investigators. Response must last for at least 4 weeks.Stable disease:No significant change in disease for at least 4 weeks. Includes an estimated decrease of <50% and lesions with an estimated increase of <25%.Progressive disease(PD):Definite increase in area of any malignant lesion estimated to be >=25% or appearance of new lesions. Need for radiotherapy is considered PD.|Evaluated every 12 weeks during Treatment Period|||participants|||Number
700674|NCT00049257|Primary|Time to PSA Progression|In patients whose PSA has not decreased, progressive disease is a 25% increase over the baseline value and an increase in the absolute value PSA level by >=5ng/ml, confirmed by a second value at >=4 week intervals. In patients whose PSA has decreased but has not reached response criteria, progressive disease is defined as an increase in PSA by 25% over the nadir, provided that the increase is >=5ng/ml and is confirmed by a second value at >=4 week intervals.|Evaluated every 28 days during Treatment Period|||days||Full Range|Median
700675|NCT00049257|Primary|Prostate-specific Antigen (PSA) Response Rate|PSA response is defined as a decline from the baseline value of >=50% confirmed by a second PSA value 4 or more weeks later.|Evaluated every 28 days during Treatment Period. Number of completed cycles among 58 treated patients range from 1 to 24 cycles with a median of 4.5 cycles. one cycle = 28 days.|||participants|||Number
700676|NCT00049322|Secondary|Measure (Vascular Endothelial Growth Factor)VEGF Before and After TACE With and Without Bevacizumab||21 days after TACE|||fold change|||Number
700677|NCT00049322|Secondary|Assess Pharmakokinetics of Bevacizumab in Liver Disease|bevacizumab serum concentrations|day 85|||micrograms/mL||95% Confidence Interval|Mean
700678|NCT00049322|Secondary|Assess the Toxicities of Bevacizumab in Patients With Liver Function Impairment||16 weeks|subjects that completed all 16 weeks.||participants|||Number
700679|NCT00049322|Secondary|Progression Free Survival|Progression free survival (PFS) at 16 weeks (end of the core phase).|16 weeks|Arm I: Patients receive bevacizumab Arm II. Patients do not receive bevacizumab.||probablility of pfs at 16 weeks|||Number
700680|NCT00049322|Primary|Neovessel Formation as Measured by Angiogram at 14 Weeks|Angiograms were assessed for changes in vascularity. The numbers indicate how many subjects in each group showed neovessel formation.|14 weeks|||participants|||Number
700681|NCT00049504|Primary|Non-relapse-related Mortality|Number of deaths without progression or recurrence of malignant disease|Up to 200 days after transplantation|||Participants|||Count of Participants
700682|NCT00049504|Primary|Incidence of Grades III-IV Acute GVHD|Grade III GVHD represents moderate severity. Grade IV GVHD represents extreme severity|At any time within 200 days after transplantation|||Participants|||Count of Participants
700683|NCT00049504|Primary|Donor Engraftment (Chimerism)|Defined by the detection of at least 50% donor derived T-cells (CD3+), as a proportion of the total T-cell population|At day +84 after transplantation|Patients receiving haploidentical transplant who had T cell chimerism tested at day +84||Participants|||Count of Participants
700684|NCT00049517|Secondary|Overall Survival (Consolidation Phase)|Overall survival is defined as the time from randomization in the consolidation phase to death.|Assessed during the first 4 months, then at least every three months for 2 years. then every six months until five years after study entry, and every 12 months thereafter.|Only 270 patients who were randomized in the consolidation phase are included in the analysis.||Months||95% Confidence Interval|Median
700685|NCT00049517|Primary|Disease-free Survival (Consolidation Phase)|Disease-free survival is defined from the time of the confirmation of a complete remission via biopsy to the relapse of the disease.|Assessed during the first 4 months, then at least every three months for 2 years. then every six months until five years after study entry, and every 12 months thereafter.|Only 270 patients who were randomized in the consolidation phase are included in the analysis.||Months||95% Confidence Interval|Median
700686|NCT00049517|Primary|Overall Survival (Induction Phase)|Overall survival is defined as the time from randomization in the induction phase to death.|Assessed during the first 4 months, then at least every three months for 2 years. then every six months until 5 years after study entry and every 12 months thereafter.|All randomized patients are included in the analysis (intention-to-treat).||months||95% Confidence Interval|Median
700688|NCT00049530|Secondary|Progression Free Survival|Progression free survival (PFS) was defined as the time from registration to disease progression, or censored at last known date of non progressive disease.|assessed every 9 weeks until suppression of plasma b-FGF level to normal, every 12 weeks until the completion of 12 months of treatment, >= 4 weeks after documented response. After off treatment, every 3 months if <2 years, and every 6 months if 2-3 years|eligible and treated patients||months||95% Confidence Interval|Median
700689|NCT00049530|Secondary|Non-progression Rate (Clinical Response to Peginterferon Alfa-2b)|"Objective tumor response was assessed using RECIST (Response Evaluation Criteria in Solid Tumors) 1.0 criteria. Per RECIST criteria, complete response (CR) = disappearance of all target and non-target lesions. Partial response (PR)= >=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits. Progression is defined as at least 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s) or unequivocal progression of existing non-target lesions. Stable disease (SD) = did not meet criteria for response or progression.
Non-progression rate = CR + PR + SD."|assessed every 9 weeks until suppression of plasma b-FGF level to normal, every 12 weeks until the completion of 12 months of treatment, >= 4 weeks after documented response. After off treatment, every 3 months if <2 years, and every 6 months if 2-3 years|eligible and treated patients||percentage of participants||95% Confidence Interval|Number
700690|NCT00049530|Primary|Plasma b-FGF Level Response|The primary endpoint was the suppression of plasma b-FGF level with low dose peginterferon alfa-2b. A clinically important reduction of plasma b-FGF levels was determined to be a level less than or equal to 7.5 pg/mL. A patient was considered to have a suppressed plasma b-FGF level, if the patient experienced the clinically significant reduction (less than or equal to 7.5 pg/mL) of plasma b-FGF levels for two consecutive determinations which were at least three weeks apart. This was considered as a b-FGF response.|assessed every 3 weeks until the suppression of plasma b-FGF level to normal, then every 6 weeks until the completion of 12 months of treatment, and upon treatment discontinuation|eligible and treated patients||percentage of participants||95% Confidence Interval|Number
700691|NCT00049543|Secondary|Incidence of Toxicities Graded Using the NCI Common Terminology Criteria for Adverse Events Version 3.0|The incidence of toxicities will be summarized by type of adverse event and severity. A Fisher’s exact test will be used to compare toxicities between the two arms.|Up to 5 years|All patients who received at least 1 dose of the treatment||participants|||Number
700692|NCT00049543|Secondary|Disease Free Survival|The survival experience of patients in both treatment groups will be described by the Kaplan-Meier method. A stratified log-rank test will be used as the primary method to compare the disease free survival between two arms adjusting for the stratification factors. Five years disease free survival rate will be reported.|From randomization to the time of documented recurrence of the primary cancer, assessed up to 5 years|ITT population||percentage of 5-year disease free rate||95% Confidence Interval|Number
700693|NCT00049543|Primary|Overall Survival|The survival experience of patients in both treatment groups will be described by the Kaplan-Meier method. A stratified log-rank test will be used as the primary method to compare the overall survival between two arms adjusting for the stratification factors. An unadjusted analysis will also be performed. Five years survival rate will be reported.|From randomization to the time of death from any cause, assessed up to 5 years|ITT population||percentage of 5 years survival rate||95% Confidence Interval|Number
700694|NCT00038467|Secondary|Number of Participants With Histological Findings: Endometrial Sub-study||Baseline up to 24 months post-treatment|Results were not reported for this outcome measure because no data was collected as per change in planned analysis.|||||
700695|NCT00038467|Secondary|Percentage of Participants With at Least 1 Gynecological Symptoms: Endometrial Sub-study|Gynecological symptoms included bleeding/spotting, pelvic pain, leucorrhoea and vaginal itching.|Baseline up to 24 months post-treatment|As treated population included all treated participants, irrespective of the treatment duration and allocated to the group that corresponded to the treatment they actually received.||percentage of participants|||Number
700696|NCT00038467|Secondary|Number of Participants With Polyps, Fibroids and Ovarian Cysts: Endometrial Sub-study|Number of participants with presence of polyps (POL) and fibroids (FIB) at post-baseline time points compared to the baseline (BL) status of ‘yes’, ‘no’ or ‘missing’ (that is, participants reporting POL/FIB at post-baseline time points who had yes, no or missing POL/FIB status at baseline, respectively) were presented. Result for number of participants with ovarian cysts was not analyzed at post-baseline time points as very few participants reported ovarian cysts at baseline.|6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment|Evaluable population for endometrial sub-study. Analysis was based on actual treatment received. 'n' signifies those participants who were evaluable for this measure at given time points for each group,respectively.||participants|||Number
700697|NCT00038467|Secondary|Uterine and Overall Ovary Volume: Endometrial Sub-study|Uterine volume (UV) and ovarian volume was estimated using ultrasonography. Uterine volume = (longitudinal diameter * transverse diameter * anteroposterior diameter of uterus)/(2*1000). Ovary volume = [(longitudinal diameter * transverse diameter * anteroposterior diameter of ovary) * 3.14]/(6*1000). Overall ovary volume (OV) is calculated as the sum of the right and left ovary volume. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment|Evaluable population for endometrial sub-study included all treated participants who did not violate any exclusion criteria, received treatment for at least 2 years, and had on-treatment endometrial ultrasound examination performed between 22 and 26 months from treatment start. Analysis was based on actual treatment received.||cubic centimeter (cm^3)||Full Range|Median
700733|NCT00039377|Secondary|5 Year Disease-free Survival for Autologous & Allogeneic Transplant Groups|Percentage of patients who achieved a complete remission (CR) and were alive and relapse free at 5 years. The 5-year progression free survival was estimated using the Kaplan Meier method.|5 years from CR|Participants who received autologous or allogeneic transplants were analyzed (N=34)||percentage of patients||95% Confidence Interval|Number
701553|NCT00054327|Primary|Rates of Durable Engraftment|Number of days that patients take to reach engraftment defined as time to hematologic engraftment will be defined as ANC >500/µl and platelets >20K/µl without transfusion support.|at day 42|||days||Standard Deviation|Mean
700698|NCT00038467|Secondary|Endometrial Thickness: Endometrial Sub-study|Endometrial thickness was assessed using transvaginal ultrasound examination. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|Baseline, 6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment|Evaluable population for endometrial sub-study included all treated participants who did not violate any exclusion criteria, received treatment for at least 2 years, and had on-treatment endometrial ultrasound examination performed between 22 and 26 months from treatment start. Analysis was based on actual treatment received.||mm||Full Range|Median
700699|NCT00038467|Secondary|Percentage of Participants With Endometrial Thickness Greater Than or Equal to (>=) 5 Millimeter (mm): Endometrial Sub-study|Endometrial thickness was assessed using transvaginal ultrasound examination. 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment|Evaluable population for endometrial sub-study included all treated participants who did not violate any exclusion criteria, received treatment for at least 2 years, and had on-treatment endometrial ultrasound examination performed between 22 and 26 months from treatment start. Analysis was based on actual treatment received.||percentage of participants|||Number
700700|NCT00038467|Secondary|Number of Participants With Severe Endocrine Symptoms: QoL Sub-study|Participants indicated prevalence of an endocrine subscale items using a 5-point scale, where 0 (not at all), 1 (a little bit), 2 (somewhat), 3 (quite a bit), 4 (very much). Endocrine items were grouped in five categories vasomotor (hot flushes, cold sweats, night sweats, sleeping difficulties), neuropsychological (lack of energy, nervous feeling, lightheaded/dizzy, headaches, mood swings, feeling irritable), gastrointestinal symptoms (nausea, gained weight, vomiting, diarrhea, bloated feeling), gynecological symptoms (vaginal discharge, vaginal irritation, vaginal bleeding, vaginal dryness, discomfort with intercourse, lost interest in sex, breast tenderness) and other symptoms (pain, feeling ill, side effects). Number of participants who reported severe endocrine symptoms (defined as response categories “quite a bit” and “very much”) were presented.|Baseline up to 24 months after randomization|ITT population for QoL sub-study. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation.||participants|||Number
700701|NCT00038467|Secondary|Change From Baseline in Breast Cancer Subscale (BCS) Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study|The BCS subscale assessed health related QoL in participants with breast cancer. BCS subscale comprised of 9 items (short of breath, self-conscious dress, tender/swollen arms, sexually attractive, bothered by hair loss, worried about familial risk, worried about family stress, bothered by weight change, able to feel like a woman). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). For items that were negatively framed, the scores were reversed for the analysis so that higher scores equated to a good QoL. Total BCS score was calculated as the sum of the 9 items and ranged from 0 to 36, where higher score indicated better QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization|ITT population for QoL sub-study. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation.||units on a scale||Standard Deviation|Mean
700702|NCT00038467|Secondary|Change From Baseline in Functional Well-Being (FWB) Sub-scale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study|The FWB subscale assessed functional well-being related QoL in participants with breast cancer. FWB subscale comprised of 7 items (able to work, work fulfilled, able to enjoy life, acceptance of illness, sleeping well, enjoyed normal fun activities, contented with QoL). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). Total FWB score was calculated as the sum of the 7 items and ranged from 0 to 28, where higher score indicated better functional well-being related QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization|ITT population for QoL sub-study. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation.||units on a scale||Standard Deviation|Mean
700703|NCT00038467|Secondary|Change From Baseline in Emotional Well-Being (EWB) Subscale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study|The EWB subscale assessed emotional well-being related QoL in participants with breast cancer. EWB subscale comprised of 6 items (felt sad, proud of coping, lost hope, felt nervous, worried about dying, worried about condition worsening). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). For items that were negatively framed, the scores were reversed for the analysis so that higher scores equate to a good QoL. Total EWB score was calculated as the sum of the 6 items and ranged from 0 to 24, where higher score indicated better emotional well-being related QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization|ITT population for QoL sub-study. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation.||units on a scale||Standard Deviation|Mean
700704|NCT00038467|Secondary|Change From Baseline in Relationship With Doctor (RWD) Subscale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Substudy|The RWD subscale assessed relationship with doctor in participants with breast cancer. RWD subscale comprised of 2 items (confidence in doctors, doctor answered questions). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). Total RWD score was calculated as the sum of the 2 items and ranged from 0 to 8, where higher score indicated better relationship with doctor. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization|ITT population for QoL sub-study. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation.||units on a scale||Standard Deviation|Mean
700705|NCT00038467|Secondary|Change From Baseline in Social/Family Well-Being (SWB) Sub-scale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study|The SWB subscale assessed social/family well-being related QoL in participants with breast cancer. SWB subscale comprised of 7 items (distant from friends, emotional support, support from friends, family acceptance, family communication, close to main support, sexual satisfaction). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). For items that were negatively framed, the scores were reversed for the analysis so that higher scores equated to a good QoL. Total SWB score was calculated as the sum of all the 7 items and ranged from 0 to 28, where higher score indicated better social/family well-being related QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization|ITT population for QoL sub-study. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation.||units on a scale||Standard Deviation|Mean
700706|NCT00038467|Secondary|Change From Baseline in Physical Well-Being (PWB) Subscale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study|The PWB subscale assessed physical well-being related QoL in participants with breast cancer. PWB subscale comprised of 7 items (energy lack, nausea, family needs, pain, side effects, felt ill, forced to stay in bed). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). For items that were negatively framed, the scores were reversed for the analysis so that higher scores equated to a good QoL. Total PWB score was calculated as the sum of all the 7 items and ranged from 0 to 28, where higher score indicated better physical well-being related QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization|ITT population for QoL sub-study. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation.||units on a scale||Standard Deviation|Mean
700707|NCT00038467|Secondary|Change From Baseline in Total Functional Assessment of Cancer Therapy – General Breast and Endocrine (FACT-GBE) Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study|FACT-GBE assessed health-related quality of life (QoL) in participants with breast cancer. It consisted of 56 items,summarized to 7 subscales(subscale 1 to 6 constituted total FACT-B and subscale 7 constituted total ES):physical well-being(7 items), social/family well-being(7 items),relationship with doctor (2 items),emotional well-being(6 items),functional well-being(7 items),breast cancer subscale(9 items),endocrine symptoms(18 items). Participants indicated how true a statement had been for them using 5-point scale from 0(not at all) to 4(very much). For items that were negatively framed,scores were reversed for analysis so that higher scores equated to good QoL. Total FACT-GBE score=sum of all 56 items(range 0 to 224, where higher score indicated better QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization|ITT population for QoL sub-study. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation.||units on a scale||Standard Deviation|Mean
700708|NCT00038467|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy – Endocrine Subscale (FACT-ES) Total Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study|The FACT-ES assessed health-related QoL in participants with breast cancer. ES subscale comprised of 18 items (hot flushes,cold sweats,night sweats, vaginal discharge,vaginal irritation,vaginal bleeding,vaginal dryness,discomfort with intercourse,lost interest in sex,gained weight,light headed/dizzy,vomiting,had diarrhea,headaches,felt bloated,breast tenderness,mood swings, felt irritable).Participants indicated how true a statement was for them using a 5-point scale from 0 (not at all) to 4 (very much). For items that were negatively framed, the scores were reversed for the analysis so that higher scores equated to a good QoL. Total FACT-ES score was calculated as sum of all the 18 items and ranged from 0 to 72, where higher score indicated better QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization|ITT population for QoL sub-study. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation.||units on a scale||Standard Deviation|Mean
700709|NCT00038467|Secondary|Change From Baseline in Treatment Outcome Index (TOI) at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study|The TOI was defined as the sum of 23 items based on following Functional Assessment of Cancer Therapy – Breast version [FACT-B] subscales: Physical well-being (7 items), Functional well-being (7 items), Breast cancer subscale (9 items). Each item was scaled from 0=‘Not at all’ to 4=‘Very much’. Total TOI score ranged from 0 to 92, where higher TOI score indicated better health-related quality of life (QoL). A change of five points in the TOI scores was considered clinically meaningful. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation.|Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization|ITT population for QoL sub-study included all randomized participants with available data for any given endpoint and were grouped according to randomized treatment, irrespective of whether they were actually treated or not.||units on a scale||Standard Deviation|Mean
700710|NCT00038467|Secondary|Number of Participants With Fracture: Bone Metabolism Sub-study||Baseline up to 24 months post-treatment|As treated population for bone metabolism sub-study included all treated participants, irrespective of the treatment duration and allocated to the group that corresponded to the treatment they actually received.||participants|||Number
700843|NCT00044512|Secondary|Duration of Stable Disease|Time from the first day of receiving study drug until there was a documented PD or response.|up to 3 years later|Intention to Treat (ITT) analyses were performed on all treated subjects and for subgroups such as baseline Child Pugh status (A vs B), ECOG PS (0 vs 1), TNM stage at study entry (II/III vs IV), hepatitis B and hepatitis C status (positive vs negative).||days||95% Confidence Interval|Median
700711|NCT00038467|Secondary|Percentage of N-telopeptide of Type 1 Collagen (NTX) Urine Concentration Relative to Baseline: Bone Metabolism Sub-study|N-telopeptide of Type 1 collagen (NTX) urine concentration (adjusted for urinary creatinine) analyzed using competitive inhibition EIA at post-baseline time points was expressed as percentage of baseline NTX urine concentration. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment|As treated population for bone metabolism sub-study included all treated participants, irrespective of the treatment duration and allocated to the group that corresponded to the treatment they actually received. Analysis population for biomarkers included as treated population with baseline and at least 1 on-treatment assessment available.||percentage of baseline concentration||95% Confidence Interval|Geometric Mean
700712|NCT00038467|Secondary|Percentage of Deoxy-pyridinoline (DPD) Urine Concentration Relative to Baseline: Bone Metabolism Sub-study|Deoxy-pyridinoline (DPD) urine concentration (adjusted for urinary creatinine) analyzed using competitive EIA at post-baseline time points was expressed as percentage of baseline DPD urine concentration. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment|As treated population for bone metabolism sub-study included all treated participants, irrespective of the treatment duration and allocated to the group that corresponded to the treatment they actually received. Analysis population for biomarkers included as treated population with baseline and at least 1 on-treatment assessment available.||percentage of baseline concentration||95% Confidence Interval|Geometric Mean
700713|NCT00038467|Secondary|Percentage of Osteocalcin (OC) and Procollagen T1 C-Peptide (PICP) Serum Concentration Relative to Baseline: Bone Metabolism Sub-study|Osteocalcin (OC) serum concentration analyzed using ELISA and procollagen T1 c-peptide (PICP) serum concentration analyzed using sandwich EIA at post-baseline time points was expressed as percentage of baseline OC serum concentration and baseline PICP serum concentration, respectively. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points, for each group respectively.|Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment|As treated population for bone metabolism sub-study included all treated participants, irrespective of the treatment duration and allocated to the group that corresponded to the treatment they actually received. Analysis population for biomarkers included as treated population with baseline and at least 1 on-treatment assessment available.||percentage of baseline concentration||95% Confidence Interval|Geometric Mean
700714|NCT00038467|Secondary|Percentage of C-Terminal Telopeptide (CTX) Serum Concentration Relative to Baseline: Bone Metabolism Sub-study|C-terminal telopeptide (CTX) serum concentration analyzed using competitive enzyme-linked immunosorbent assay (ELISA) at post-baseline time points was expressed as percentage of baseline CTX serum concentration. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment|As treated population for bone metabolism sub-study included all treated participants, irrespective of the treatment duration and allocated to the group that corresponded to the treatment they actually received. Analysis population for biomarkers included as treated population with baseline and at least 1 on-treatment assessment available.||percentage of baseline concentration||95% Confidence Interval|Geometric Mean
700715|NCT00038467|Secondary|Percentage of Bone Specific Alkaline Phosphatase (BAP) Serum Concentration Relative to Baseline: Bone Metabolism Sub-study|Bone specific alkaline phosphatase (BAP) serum concentration analyzed using enzyme immuno assay (EIA) at post-baseline time points was expressed as percentage of baseline BAP serum concentration. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment|As treated population for bone metabolism sub-study included all treated participants, irrespective of the treatment duration and allocated to the group that corresponded to the treatment they actually received. Analysis population for biomarkers included as treated population with baseline and at least 1 on-treatment assessment available.||percentage of baseline concentration||95% Confidence Interval|Geometric Mean
700716|NCT00038467|Secondary|Change From Baseline in Lumbar Spine and Proximal Femur (Total Hip) Bone Mineral Density (BMD) T-scores at 6, 12 and 24 Months On-treatment and 24 Months Post-treatment: Bone Metabolism Sub-study|BMD measurements for Lumbar spine (LS) and Proximal Femur (Total Hip [TH]) were performed using dual energy X-ray absorptiometry (DXA) for participants who entered the bone-metabolism sub-study. Results were scored as T-score. T-score indicated how many standard deviations higher or lower participant’s value was when compared to the young normal reference mean. Using the World Health Organization (WHO) criteria for osteoporosis, a T-score of greater than or equal to (>=)-1.0 was classified as normal, a T-score of greater than -2.5 to less than -1.0 as osteopenic, and a T-score less than or equal to (<=)-2.5 as osteoporotic. Here 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|Baseline, 6, 12, 24 months after randomization (on-treatment), 24 months post-treatment|Evaluable population for bone metabolism substudy: all treated participants who did not violate any exclusion criteria, received treatment for at least 9 months and had baseline and at least on-treatment Month 12 and/or Month 24 assessment available for parameter to be analyzed. Participants were analyzed according to treatment actually received.||T-score||Standard Deviation|Mean
700844|NCT00044512|Secondary|Time to Progression|Time from the first date of receiving study drug until the first documented PD.|up to 3 years later|Intention to Treat (ITT) analyses were performed on all treated subjects and for subgroups such as baseline Child Pugh status (A vs B), ECOG PS (0 vs 1), TNM stage at study entry (II/III vs IV), hepatitis B and hepatitis C status (positive vs negative).||days||95% Confidence Interval|Median
700717|NCT00038467|Secondary|Percent Change From Baseline in Femoral Neck and Femoral Wards Bone Mineral Density (BMD) at 6, 12 and 24 Months On-treatment and 24 Months Post-treatment: Bone Metabolism Sub-study|BMD measurements for femoral neck (FN) and femoral wards (FW) were performed using dual energy X-ray absorptiometry (DXA) for participants who entered the bone-metabolism sub-study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|Baseline, 6, 12, 24 months after randomization (on-treatment), 24 months post-treatment|Evaluable population for bone metabolism substudy: all treated participants who did not violate any exclusion criteria, received treatment for at least 9 months and had baseline and at least on-treatment Month 12 and/or Month 24 assessment available for parameter to be analyzed. Participants were analyzed according to treatment actually received.||percent change||Standard Deviation|Mean
700718|NCT00038467|Secondary|Percent Change From Baseline in Lumbar Spine and Proximal Femur (Total Hip) Bone Mineral Density (BMD) at 6, 12, 24 Months On-treatment and 24 Months Post-treatment: Bone Metabolism Sub-study|BMD measurements for Lumbar spine (LS) and Proximal Femur (Total Hip [TH]) were performed using dual energy X-ray absorptiometry (DXA) for participants who entered the bone-metabolism sub-study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|Baseline, 6, 12, 24 months after randomization (on-treatment), 24 months post-treatment|Evaluable population for bone metabolism substudy: all treated participants who did not violate any exclusion criteria, received treatment for at least 9 months and had baseline and at least on-treatment Month 12 and/or Month 24 assessment available for parameter to be analyzed. Participants were analyzed according to treatment actually received.||percent change||Standard Deviation|Mean
700719|NCT00038467|Secondary|Number of Events of Second Breast Cancer in Contralateral Breast: Main Study|Number of events of second primary breast cancer in contralateral breast (excluding ductal carcinoma in situ) were reported.|Baseline up to Month 120|ITT population included all participants assigned to the treatment group to which they were randomized, irrespective of the treatment they actually received.||events|||Number
700720|NCT00038467|Secondary|Overall Survival (OS) at Month 36 Post-Randomization: Main Study|OS was defined as the duration from randomization to death (due to any cause). OS at Month 36 post-randomization was defined as probability of participants’ survival at 36 months after the randomization. For participants who were alive, OS was censored at the last available assessment. Probability of OS at Month 36 post-randomization was reported using Kaplan-Meier estimates at Month 36 post-randomization based on 120-month follow-up data.|Baseline up to Month 120|ITT population included all participants assigned to the treatment group to which they were randomized, irrespective of the treatment they actually received.||probability of OS||95% Confidence Interval|Number
700721|NCT00038467|Primary|Disease-Free Survival (DFS) at Month 36 Post-Randomization: Main Study|DFS defined as time from randomization to earliest documentation of breast cancer relapse or death from any cause. DFS at Month 36 post-randomization was defined as probability of participants alive and disease-free at 36 months after the randomization. Participants withdrawn from the study for any reason in the absence of relapse were censored at the date they were last seen. Relapse was categorized as follows: loco-regional: ipsilateral breast or axillary nodal relapse; distant: distant relapse, including supraclavicular nodes; second primary breast cancer: contralateral breast cancer, excluding ductal carcinoma in situ.|Baseline up to Month 36|Intent-to-treat (ITT) population included all participants assigned to the treatment group to which they were randomized, irrespective of the treatment they actually received.||probability of DFS||95% Confidence Interval|Number
700722|NCT00038610|Primary|Disease-Free Survival Rate at 2-year and 5-year.|Disease-Free Survival (DFS) was calculated from the time of complete remission until relapse or death due to any cause.|Baseline to 2-year and 5-year|||percentage of participants|||Number
700723|NCT00038610|Secondary|Overall Survival Rate at 2-year and 5-year.|Overall survival (OS) was calculated from the date of initiation of therapy until death.|Baseline to 2-year and 5-year|||percentage of participants|||Number
700724|NCT00038610|Primary|Response To Induction Therapy With Hyper-CVAD Plus Imatinib Mesylate|"Complete Remission (CR): Defined as the presence of 5% or less blasts in the bone marrow, with a granulocyte count of 1.0 × 109/L or higher and a platelet count of 100 × 109/L and no extramedullary disease.
Partial Response (PR): As above for CR except for the presence of 6-25% marrow blasts.
Molecular CR: Same as for CR with RT-PCR negativity for bcr-abl.
Induction Death: Defined as death occurring after start of therapy without meeting the definition of CR or resistant disease."|Baseline to 6 months|Of the 54 participants, 39 (72%) presented with de novo disease, 6 (11%) were refractory to standard induction therapy, and 9 (17%) entered the study in complete remission (CR) after one course of standard induction therapy.||participants|||Number
700725|NCT00038857|Primary|Number of Participants With Absolute Neutrophil Count Engraftment|Absolute neutrophil engraftment defined as first of 3 consecutive days with Absolute neutrophil count (ANC) equal to or more than 0.5 * 10^9/L. Baseline to Day 30 post transplant.|Day 0 up to Day 30|Analysis per protocol.||participant|||Number
700726|NCT00038948|Secondary|First Occurrence of Biopsy-confirmed Acute Rejection, Graft Loss, or Death.|Number of patients who experienced for the first time either biopsy-confirmed acute rejection, graft loss, or death by weeks 52 and 104. Assessed by individual endpoint and as composite endpoint (all combined).|52 and 104 weeks|Patients were stratified by GFR at baseline. GFR 20-40 mL/min and GFR >40 mL/min.||patients|||Number
700727|NCT00038948|Primary|Nankivell Glomerular Filtration Rate (GFR)|Nankivell GFR: patients with baseline GFR of 20.0 to 40.0 mL/min and patients with baseline GFR of greater than 40.0 mL/min. GFR is an index of kidney function. A higher value means better kidney function.|52 weeks|Patients were stratified by GFR at baseline. GFR 20-40 mL/min and GFR >40 mL/min.||mL/min||Standard Error|Mean
700728|NCT00039130|Secondary|2 Year Overall Survival|Percentage of participants who were alive at 2 years. The 2 year survival, with 95% confidence interval, was estimated using the Kaplan Meier method.|2 years|||percentage of participants||95% Confidence Interval|Number
700729|NCT00039130|Secondary|2 Year Event Free Survival|Percentage of patients who were event free at 2 years. The 2-year event free rate was estimated using the Kaplan Meier method. An event is defined as death, progression or treatment failure.|2 years|||percentage of participants||95% Confidence Interval|Number
700734|NCT00039377|Primary|Disease Free Survival|"Disease-free survival (DFS) was measured as the interval from achievement of complete remission (CR) until relapse or death, regardless of cause; patients alive and in CR were censored at last follow-up. DFS was estimated using the Kaplan Meier method.
A complete remission (CR) was defined as recovery of morphologically normal bone marrow and blood counts (i.e., neutrophils >= 1.5 x 10^9/L and platelets > 100 x 10^9/L) and no circulating leukemic blasts or evidence of extramedullary leukemia and persisting for at least one month."|Duration of treatment (up to 10 years)|One participant was excluded per study design as they did not achieve a complete remission. DFS Analysis was powered to include all patients.||years||95% Confidence Interval|Median
700735|NCT00039377|Secondary|Number of Participants Who Achieved a BCR-ABL Response at 12 Months|"BCR-ABL response is defined in two ways: complete molecular response (CMR) and major molecular response (MMR).
Complete Molecular Response is defined as a Bcr-Abl (a fusion of gene of Bcr and ABl genes) ratio ≤0.0032% on the International Scale Bcr = breakpoint cluster gene Abl = abelson proto-oncogene
MMR is defined as Bcr-Abl (A fusion gene of the breakpoint cluster region [Bcr] gene and Abelson proto-oncogene [Abl] genes) transcript ratio ≤0.1% (≥ 3 log reduction of BCR-ABL transcripts from a standardized baseline), as detected by reverse transcriptase polymerase chain reaction [RT-PCR] (performed centrally)."|12 months|Peripheral blood stem cells were assayed from 13 patients.||participants|||Number
700736|NCT00039377|Secondary|Overall Survival|Overall survival (OS) as the interval from the on-study date until death. OS was estimated using the Kaplan Meier method.|Duration of study (up to 10 years)|OS Analysis was powered to include all participants.||years||95% Confidence Interval|Median
700737|NCT00039741|Secondary|Number of Children With HIV-1 RNA Less Than 400 Copies/ml and on Original Randomized Therapy at 24 Weeks||24 weeks|Intent to treat - numbers are reported among participants who had an HIV-1 RNA value and were in follow-up at week 24.||participants|||Number
700738|NCT00039741|Secondary|Change in CD4% From Randomization to 4 Years||Randomization to 4 years|Intent to treat, for participants who had CD4% values available at 4 years and at baseline.||CD4 percent (% of total lymphocytes)||Standard Deviation|Mean
700739|NCT00039741|Secondary|Number of Children With an HIV-1 RNA Level Less Than 400 Copies/ml Regardless of Therapy at Week 204||Week 204|Intent to treat. Numbers are reported among participants who had an HIV-1 RNA value and were in follow-up at week 204.||participants|||Number
700740|NCT00039741|Secondary|Time to HIV-1 RNA of 30,000 Copies/ml or Greater During Second-line Therapy or Permanent Discontinuation of Second-line Therapy|25th Percentiles in weeks from randomization to HIV-1 RNA of 30,000 copies/ml or greater during second-line therapy or permanent discontinuation of second-line therapy|Up to 6 yrs. (average 4.85 yrs.)|Intent to treat||Weeks (25th Percentile)|||Number
700741|NCT00039741|Secondary|Time to HIV-1 RNA of 400 Copies/ml or Greater During First-line Therapy or Permanent Discontinuation of First-line Therapy|25th Percentiles in weeks from randomization HIV-1 RNA of 400 copies/ml or greater during first-line therapy or permanent discontinuation of first-line therapy.|Up to 6 yrs. (average 4.85 yrs.)|Intent to treat||Weeks (25th Percentile)|||Number
700742|NCT00039741|Secondary|Time to Switching to an Alternative Class ART Regimen (Based on Initial Randomized Regimen)|25th Percentiles in weeks from randomization to starting an alternative class ART regimen (based on initial randomized regimen)|Up to 6 yrs. (average 4.85 yrs.)|Intent to treat||Weeks (25th Percentile)||Inter-Quartile Range|Median
700743|NCT00039741|Secondary|Participants With Significant HIV-related Clinical Events, Defined as CDC Category C (AIDS Defining) Diagnoses (Except for Recurrent Bacterial Infections)or Death||Up to 6 yrs. (average 4.85 yrs.)|Intent to treat||participants|||Number
700744|NCT00039741|Secondary|Rate of Grade 3 or Higher Signs, Symptoms, or Laboratory Abnormalities Experienced|"Adverse events were graded according to the following guidelines:
PACTG: “The Manual for Expedited Reporting of Adverse Events to DAIDS” (DAIDS EAE Manual) dated May 6, 2004.
PENTA: International Conference for Harmonization (ICH) requirements and the EU Clinical Trials Directive 2001/20/EC (20).
A rating of Grade 3 is severe and Grade 4 is life-threatening. The rate of serious (Grade 3 or above)events is reported as the number of events per 100 child/years."|Up to 6 yrs. (average 4.85 yrs.)|Intent to treat||events/100 child-years||95% Confidence Interval|Mean
700745|NCT00039741|Primary|Change in Viral Load Measured in log10 HIV-1 RNA Copies/ml||Baseline visit and 4 years after Study Entry|Intent-to-treat analyses for those subjects who had data at baseline and 4 years. Analyses were done by collapsing groups to examine drug class (regardless of switch point) and switch point (regardless of drug class).||log10 HIV-1 RNA||Standard Error|Mean
700746|NCT00039871|Secondary|Sustained Virologic Response (SVR) for Participants With Detectable But ≥2 Log Drop in HCV-RNA at Treatment Week 12|Number of participants with detectable HCV-RNA but ≥2 log drop from baseline in HCV-RNA at Treatment Week 12 who had subsequent undetectable HCV-RNA after 24 weeks of posttreatment follow-up|24 weeks posttreatment|Participants with detectable but >=2 log drop in HCV-RNA at Treatment Week 12||Participants|||Number
700747|NCT00039871|Secondary|Sustained Virologic Response (SVR) for Participants With Undetectable HCV-RNA at Treatment Week 12|Number of participants with undetectable HCV-RNA at Treatment Week 12 who had subsequent undetectable HCV-RNA after 24 weeks of posttreatment follow-up|24 weeks posttreatment|Participants who had undetectable HCV-RNA at Treatment Week 12||Participants|||Number
700748|NCT00039871|Primary|Sustained Virologic Response (SVR) Rate|Number of participants with undetectable hepatitis C virus RNA (HCV-RNA)|Assessed at end of 24 weeks posttreatment follow-up|Participants who received at least one dose of study medication||Participants|||Number
700749|NCT00040365|Secondary|Number of Participants Who Had Proctoscopic Examinations|Proctoscopic scoring of mucosal change was performed according to a descriptive scale, described by Wachter et al, which assigns grades of mucosal congestion, telangiectasia, ulcerations, stricture, and necrosis.|3 years|||Participants|||Number
700750|NCT00040365|Secondary|Measures of Quality of Life (QOL)-(Late Follow-up 18 Months)|Radiation toxicity consists of the Radiation Therapy Oncology Group(RTOG)acute(within 90 days of treatment)and RTOG late(>90days after treatment). This scoring system assigns a toxicity grade (0-4) based on symptoms with 0 being the best outcome. The Expanded Prostate Cancer Index Composite(EPIC) questionnaire consists of 50 quality of life items divided into 4 domains, urinary, bowel, sexual and hormonal. Each independent domain renders a scoring of 0-100 with 100 being the best score. The EPIC and RTOG scores were correlated not combined.|Baseline, week 5, 7 , and months 1, 3, 6, 12, and 18|||scores on a scale||Full Range|Mean
700751|NCT00040365|Secondary|Expanded Prostate Cancer Index Composite (EPIC) Bowel Assessment Over Time (Late Follow-up 18 Months)|The EPIC bowel assessment is a 26 item short form evaluation that assess patient function and bother after prostate treatment. The Expanded Prostate Cancer Index Composite is a self assessment questionnaire designed to measure quality of life in patients with prostate cancer. The questionnaire is scored on a scale of 0-100 with higher scores correlated with higher function and quality of life. For this study, the Bowel Domain was analyzed alongside the RTOG acute and late gastrointestinal morbidity scores. For details re: EPIC, see http://www.med.umich.edu/urology/research/EPIC/EPIC-2.2002.pdf|18 months|||scores on a scale||Standard Deviation|Mean
700752|NCT00040365|Secondary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|3 years|||Participants|||Number
700753|NCT00040365|Secondary|Percentage of Participants With a Good Toxicity Outcome Who Experienced Late Rectal Toxicity and Received Topical Administrations of Amifostine in Conjunction With High Dose, 3D Conformal Radiotherapy for Prostate Cancer.|A good toxicity outcome is defined as having less than grade 2 on both weeks 5 and 7 of treatment. Week 5, 7 were during treatment measuring acute toxicity. The Radiation Therapy Oncology Group (RTOG) Acute radiation morbidity scoring scheme and the Rectal Mucosal Toxicity response criteria will be used to assess rectal toxicity. The RTOG measures the rectal toxicities. The physician assigns a grade based on symptoms reported by the patient. For details about the RTOG see http://www.rtog.org/ResearchAssociates/AdverseEventReporting/AcuteRadiationMorbidityScoringCriteria.aspx.|The late rectal toxicity has been assessed at 1, 3, 6, 12, 18, 24, 36, and 60 months after the completion of treatment.|||Percentage of Participants|||Number
700754|NCT00040365|Primary|Percentage of Participants With a Good Toxicity Outcome Who Experienced an Acute Rectal Toxicity and Received Topical Administrations of Amifostine in Conjunction With High Dose, 3D Conformal Radiotherapy for Prostate Cancer.|A good toxicity outcome is defined as having less than grade 2 on both weeks 5 and 7 of treatment. The Radiation Therapy Oncology Group (RTOG) Acute radiation morbidity scoring scheme and the Rectal Mucosal Toxicity response criteria will be used to assess rectal toxicity. The RTOG measures the rectal toxicities. The physician assigns a grade based on symptoms reported by the patient. For details about the RTOG (method and scoring of radiation morbidity, etc.) see http://www.rtog.org/ResearchAssociates/AdverseEventReporting/AcuteRadiationMorbidityScoringCriteria.aspx|RTOG Acute was used on week 5 and 7|Number of participants 29 versus 30 = One patient was taken off study due to tumor progression prior to the follow up period.||Percentage of Participants|||Number
700755|NCT00049842|Secondary|Number of Participants With no Worsening (ie, the Response Status of Improved/ no Change) in the METAVIR Activity Score During the Treatment.|"Definitions:
Activity Scoring: A0 (no histological activity), A1 (minimal activity), A2 (moderate activity), A3 (severe activity), A4 (lobular chronic hepatitis).
Improved: Participants whose METAVIR activity score at up to Month-36 decreases by 1 or more units compared to baseline.
No Change: Participants whose METAVIR activity score at up to Month-36 is the same as the baseline score.
Worsened: Participants whose METAVIR activity score at up to Month-36 increases by 1 or more units compared to baseline."|Baseline to up to Month-36|Population is ITT. Participants with missing Month-36 biopsy slides were classified as “no change”, including 88 participants in the PEG-Intron group and 104 participants in the Observed group.||Participants|||Number
700756|NCT00049842|Secondary|Mean Change in the METAVIR Activity Score (Using a Continuous Scale)|"The change of Metavir Activity Score = Metavir Activity Score at up to Month-36 - Metavir Activity Score at Baseline.
Activity Scoring: 0 (no histological activity), 1 (minimal activity), 2 (moderate activity), 3 (severe activity), 4 (lobular chronic hepatitis)."|Baseline to up to Month-36|ITT population who had both pre and up to Month-36 METAVIR activity score.||Units on a scale||Standard Deviation|Mean
700757|NCT00049842|Secondary|The Number of Participants Whose METAVIR Fibrosis Score Did Not Worsen (ie, the Response Status of Improved/no Change) During Treatment Compared to Baseline|"Definitions:
Fibrosis scoring: F0 (no fibrosis), F1 (stellate enlargement of portal tract without septa formation, F2 (enlargement of portal tract with rare septa formation, F3 (numerous septa without cirrhosis), F4 (cirrhosis).
Improved: Participants whose METAVIR fibrosis score at up to Month-36 decreases by 1 or more units compared to baseline.
No Change: Participants whose METAVIR fibrosis score at up to Month-36 is the same as the baseline score.
Worsened: Participants whose METAVIR fibrosis score at up to Month-36 increases by 1 or more units compared to baseline."|Baseline to up to Month-36|Population is ITT. Participants with missing Month-36 biopsy slides were classified as “no change”, including 88 participants in the PEG-Intron group and 104 participants in the Observed group.||Participants|||Number
700758|NCT00049842|Secondary|Mean Change From Baseline to up to Month-36 in the METAVIR Fibrosis Score (Using a Continuous Scale)|"The change of Metavir Fibrosis Score = Metavir Fibrosis Score at up to Month-36 - Metavir Fibrosis Score at Baseline.
Fibrosis scoring: 0 (no fibrosis), 1 (stellate enlargement of portal tract without septa formation, 2 (enlargement of portal tract with rare septa formation, 3 (numerous septa without cirrhosis), 4 (cirrhosis)."|Baseline to up to Month-36|ITT population who had both pre and up to Month-36 METAVIR fibrosis score.||Units on a scale||Standard Deviation|Mean
700759|NCT00049842|Secondary|Inflammation Response Status (ie, Improvement, no Change, or the Worsening of the METAVIR Activity Score as Compared to Baseline)|"Activity Scoring: A0 (no histological activity), A1 (minimal activity), A2 (moderate activity), A3 (severe activity), A4 (lobular chronic hepatitis).
Changes in liver inflammation defined as follows:
Improved: Participants whose METAVIR activity score at up to Month-36 decreases by 1 or more units compared to baseline.
No Change: Participants whose METAVIR activity score at up to Month-36 is the same as the baseline score.
Worsened: Participants whose METAVIR activity score at up to Month-36 increases by 1 or more units compared to baseline."|Baseline to up to Month-36|Population is ITT. Participants with missing Month-36 biopsy slides were classified as “no change”, including 88 participants in the PEG-Intron group and 104 participants in the Observed group.||Participants|||Number
700773|NCT00050778|Secondary|Percent Change From Baseline in T1 Cerebral Volume at Year 3|Magnetic resonance imaging (MRI) T1 was used to determine rate of cerebral atrophy (decrease in cerebral/brain volume). Partial brain volumes were measured using the technique of Losseff et al. (1996). Percent change in cerebral volume at Year 3 was calculated from MRI-T1-weighted scans as: 100*([brain volume at Year 3] minus [brain volume at Baseline]) divided by [brain volume at Baseline]).|Baseline, Year 3|Analysis population included participants in the FAS population (randomized with a correct diagnosis of MS) who had an evaluable scan for MRI-T1 brain volume at Baseline and Year 3.||percent change||Standard Deviation|Mean
700760|NCT00049842|Primary|Fibrosis Response Status (ie, Improvement, no Change, or the Worsening of the Fibrosis Score in Participants With Baseline METAVIR Fibrosis Score of F2 or F3).|"Definitions:
Fibrosis scoring: F0 (no fibrosis), F1 (stellate enlargement of portal tract without septa formation, F2 (enlargement of portal tract with rare septa formation, F3 (numerous septa without cirrhosis), F4 (cirrhosis).
Improved: Participants whose METAVIR fibrosis score at up to Month-36 decreases by 1 or more units compared to baseline.
No Change: Participants whose METAVIR fibrosis score at up to Month-36 is the same as the baseline score.
Worsened: Participants whose METAVIR fibrosis score at up to Month-36 increases by 1 or more units compared to baseline."|Baseline to up to Month-36|Population is Intent-to-Treat (ITT). Participants with missing Month-36 biopsy slides were classified as “no change”, including 88 participants in the PEG-Intron group and 104 participants in the Observed group.||Participants|||Number
700761|NCT00050011|Secondary|Rate of Change From Baseline in Total Hip BMD|The rate of change from baseline in BMD was assessed.|Baseline, 5 years|ITT population||g/sq. cm/month||95% Confidence Interval|Mean
700762|NCT00050011|Secondary|Rate of Change From Baseline in Lumbar Spine (L1-L4) BMD|The rate of change from baseline in BMD was assessed.|Baseline, 5 years|ITT population||g/sq cm/month||95% Confidence Interval|Mean
700763|NCT00050011|Secondary|Time to Disease Recurrence/Relapse|The median time to disease progression was assessed by Kaplan-Meier analysis. The Principal Investigator assessed each participant for disease recurrence at each visit. Further testing was performed at the discretion of the Principal Investigator and as clinically indicated. Disease progression was defined as chest wall and/or regional recurrence confirmed by positive cytology or biopsy, and/or distance recurrence of the 1) skin, subcutaneous tissue, and lymph nodes (other than local or regional), 2) bone marrow, 3) lung, 4) skeleton 5) liver and 6) central nervous system confirmed by positive cytology, biopsy, aspirate or radiology as appropriate.|over 5 years|ITT population||months||95% Confidence Interval|Median
700764|NCT00050011|Secondary|Incidence Rate of All Clinical Fractures|The number of participants who experienced a clinical fracture at month 36 was assessed. Initial x-ray (both AP and lateral views) of the lumbar and thoracic spine were performed at baseline to exclude participants with evidence of fracture. In addition, repeated bone scan and/or x-ray were performed at the Principal Investigator's discretion during the course of the study to confirm evidence of clinical fracture, or at month 36 if there was no evidence of clinical fracture (lumbar and thoracic spine - lateral view). X-ray films were sent to a central reader.|3 years|ITT population||Participants|||Number
700765|NCT00050011|Secondary|Percent Change From Baseline in Biochemical Markers of Bone Turnover, Serum N-Telopeptide (sNTX) and Bone-specific Alkaline Phosphatase (BSAP)|Blood samples from a subset of participants (231 participants in total) were collected to measure the sNTX and BSAP. Missing data at month 12 were imputed by using the LOCF method. Post-baseline non-missing data from months 6 and 9 were carried forward to month 12. Data prior to month 6 were not carried forward. Missing data beyond month 12 were not imputed by LOCF.|Baseline, 12 months, 2 years, 3 years, 5 years|ITT population||Percentage of biochemical markers||Standard Deviation|Mean
700766|NCT00050011|Secondary|Percent Change From Baseline in Total Hip BMD|"Bone mineral density (BMD) measurements were assessed by dual energy x-ray absorptiometry (DXA). The DXA devices of participating sites were cross-calibrated and the DXA results were compiled and analyzed by a central reader.
Percent change = 100*((BMD at Time Frame - Baseline BMD)/Baseline BMD)). Missing data at month 12 were imputed by using the LOCF method. Post-baseline non-missing data from month 6 were carried forward to month 12. Data prior to month 6 were not carried forward."|Baseline, 12 months, 2 years, 3 years, 5 years|ITT population||Percentage of BMD||Standard Deviation|Mean
700767|NCT00050011|Secondary|Percent Change From Baseline in Lumbar Spine (L1-L4) BMD|"Bone mineral density (BMD) measurements were assessed by dual energy x-ray absorptiometry (DXA). The DXA devices of participating sites were cross-calibrated and the DXA results were compiled and analyzed by a central reader.
Percent change = 100*((BMD at Time Frame - Baseline BMD)/Baseline BMD)). Missing data beyond month 12 were not imputed by LOCF."|Baseline, 2 years, 3 years, 5 years|ITT population||Percentage of BMD||Standard Deviation|Mean
700768|NCT00050011|Primary|Percent Change From Baseline in Lumbar Spine (L1-L4) Bone Mineral Density (BMD)|Bone mineral density (BMD) measurements were assessed by dual energy x-ray absorptiometry (DXA). The DXA devices of participating sites were cross-calibrated and the DXA results were compiled and analyzed by a central reader. Percent change = 100*((BMD at Month 12 - Baseline BMD)/Baseline BMD)). Missing data at month 12 were imputed by using the last observation carried forward (LOCF) method. Post-baseline non-missing data from month 6 were carried forward to month 12. Data prior to month 6 were not carried forward.|Baseline, 12 months|Intent to treat (ITT population) was used. The ITT population contained all patients in the safety population for whom at least one post-baseline efficacy measurement was collected.||Percentage of BMD||Standard Deviation|Mean
700769|NCT00050622|Secondary|Treatment Satisfaction|Parent rating of treatment satisfaction with medication, behavioral treatment, and their combination,on a scale of 1 (bad) to 7 (good).|End of Treatment|||Units on scale||Standard Deviation|Mean
700770|NCT00050622|Primary|Classroom Behavior|Daily records of percentage of assigned problems completed by children in a 60-minute classroom period.|Daily for 45 days|||Percentage of Work Completed||Standard Deviation|Mean
700771|NCT00050622|Primary|Social Behavior-Negative Verbalizations|Sum of daily frequency of Verbal Abuse toward staff members, Teasing toward peers, and Cursing/Swearing as defined by a behavioral point system that doubles as an objective measure of children's behavior. All instances of these behaviors were reported and noted as they occur throughout daily activities.|Daily for 45 days|||Number of Observed Behaviors||Standard Deviation|Mean
700772|NCT00050778|Secondary|Percent Change From Baseline in MRI T2 Lesion Volume at Year 3|Percent change in lesion volume at Year 3 was calculated from MRI-T2-weighted scans as: 100*([lesion volume at Year 3] minus [lesion volume at Baseline]) divided by [lesion volume at Baseline]).|Baseline, Year 3|Analysis population included participants in the FAS population (randomized with a correct diagnosis of MS) who had an evaluable scan for MRI-T2 lesion volume at Baseline and Year 3.||percent change||Standard Deviation|Mean
700804|NCT00051558|Secondary|Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum N-terminal Propeptide of Type 1 Procollagen||1, 6, 18, and 36 months|Subset of patients with measures of biochemical markers||percent||Standard Error|Mean
701615|NCT00054717|Secondary|Median Change From Baseline in Viral Load to Week 24||Baseline to Week 24|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Log(Copies/mL)||Inter-Quartile Range|Median
700774|NCT00050778|Secondary|Probability of Participants Who Were Relapse Free at 3 Years After Initial Treatment|Participants were considered relapse free at Year 3 if they did not experience a relapse between randomization and study completion at 36 months. Participants who discontinued early were considered relapse free if they did not experience a relapse prior to discontinuation. Probability of participants who were relapse free at Year 3, estimated using the KM method, was reported.|Year 3|FAS population included all randomized participants who had correct diagnosis of MS at entry.||probability of participants||95% Confidence Interval|Number
700775|NCT00050778|Primary|Annualized Relapse Rate|Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination, attributable to multiple sclerosis that lasted for at least 48 hours, that were present at normal body temperature, and that were preceded by at least 30 days of clinical stability. Annualized relapse rate was estimated using a Poisson regression model with observed number of relapses as a dependent variable, the log total amount of follow-up from date of randomization for each participant as an offset variable and treatment group indicator as a covariate.|Up to 3 years|FAS population included all randomized participants who had correct diagnosis of MS at entry.||relapses per participant per year||95% Confidence Interval|Number
700776|NCT00050778|Primary|Probability of Participants With Sustained Accumulation of Disability (SAD)|EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score: 0 (normal neurological examination) to 10 (death due to MS). As measured by EDSS score, SAD was defined as increase of at least 1.5 points for participants with Baseline score of 0 and increase of at least 1.0 point for participants with Baseline score of 1.0 or more; and the increase persisted for at least next the 2 scheduled assessments, that is, 6 consecutive months. The onset date of SAD was date of first EDSS assessment that began 6 month consecutive period of SAD. Participants who did not reach SAD endpoint were censored at their last visit. Probability of participants with SAD, estimated by Kaplan-Meier (KM) method, was reported.|Up to 3 years|Full Analysis Set (FAS) population included all randomized participants who had correct diagnosis of MS at entry.||probability of participants with SAD||95% Confidence Interval|Number
700777|NCT00050960|Primary|Overall Survival||From date of randomization to date of death|Intent-to-Treat (ITT)||Months||Full Range|Median
700778|NCT00050986|Secondary|Progression-free Survival (Phase II)|Efficacy measured by 6 month progression-free survival assessment.|6 months||||||
700779|NCT00050986|Primary|Maximal Tolerating Dose (MTD for Phase I)|"Phase I Dose limiting toxicity evaluation at end of first cycle based on blood tests every two weeks and participants' subjective and objective symptoms.
Start Dose Level 100 mg/m² Temozolomide once daily + 400 mg ZARNESTRA twice daily; Dose Level 1 100 mg/m² Temozolomide once daily + 500 mg ZARNESTRA twice daily; Dose Level 2 150 mg/m² Temozolomide once daily + 500 mg ZARNESTRA twice daily; Dose Level 3 150 mg/m² Temozolomide once daily + 600 mg ZARNESTRA twice daily; Dose Level 4 150 mg/m² Temozolomide once daily + 800 mg ZARNESTRA twice daily"|End of first cycle (4 weeks) evaluation|As treated.||participants|||Number
700780|NCT00051025|Secondary|Time-to-Treatment Failure||From start of first treatment||||||
700781|NCT00051025|Secondary|Duration of Response|The duration of response was defined as the time interval from start of the first response (CR or PR) to the time of documented disease progression.|From beginning of response to time of relapse|Intent-to-treat. Please note: Data represent 1 subject in each treatment group who responded.||Days|||Number
700782|NCT00051025|Primary|Objective Clinical Response: Complete Response (CR) or Partial Response (PR) at Week 24, or, in the Event of Lengthened Cycle Intervals, at the End of Cycle 8.|Complete response: achievement of a complete regression for >4 weeks of all palpable and x-ray demonstrable disease and bone marrow disease. Partial response: response to therapy with a 75% reduction in the greatest diameters of the measurable lesions for >4 weeks and had indeterminate bone marrow biopsy|24 Weeks|Intent-to-treat||Participants|||Number
700783|NCT00051168|Primary|Mean Intraocular Pressure|"Mean IOP for the patient’s worse eye at baseline was used in the secondary endpoint analysis. 2 consecutive IOP measurements for each eye were taken. If the 2 measurements for the same eye differ by 4 mmHg or less, the average of the measurements would be considered as the mean IOP for that eye. If the 2 measurements for the same eye differ by more than 4 mmHg, then a third measurement was to be taken.
All IOP measurements were performed with a Goldmann applanation tonometer."|At 5 years.|||millimeters mercury (mm Hg)||Standard Deviation|Mean
700805|NCT00051558|Secondary|Time Course of Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined|change from baseline in bone mineral density of the total hip as assessed by dual energy X-ray absorptiometry (DXA)|12, 18, 24, and 36 months|The intention-to-treat analysis was performed using all randomized and treated patients. No missing data was imputed.||grams per square centimeters||Standard Error|Least Squares Mean
700806|NCT00051558|Secondary|Time Course of Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined|change from baseline in bone mineral density of the femoral neck as assessed by dual energy X-ray absorptiometry (DXA)|12, 18, 24, and 36 months|The intention-to-treat analysis was performed using all randomized and treated patients. No missing data were imputed.||grams per square centimeters||Standard Error|Least Squares Mean
701554|NCT00054639|Primary|Number of Patients With Objective Response|Efficacy as measured by objective response complete (CR) and partial (PR) response rates at 2 months following study treatment|2 months following study treatment|Analysis was per protocol. Of the 48 participants enrolled, only 42 were evaluable for response.||participants|||Number
700799|NCT00051558|Secondary|Any Fracture, Nonvertebral Fractures, Vertebral Fractures, Clinical Vertebral Fractures, and Severity Fractures|Clinical vertebral fracture was defined as a radiographically confirmed fracture that was associated with symptoms such as back pain.|36 months|For vertebral fractures, only those patients with baseline and postbaseline spinal radiographs were included in the analysis.||participants|||Number
700800|NCT00051558|Secondary|Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Osteocalcin||1, 6, 18, and 36 months|Subset of patients with measures of biochemical markers||percent||Standard Error|Mean
700801|NCT00051558|Secondary|Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum Type 1 Collagen Degradation Fragments||1, 6, 18, and 36 months|Subset of patients with measures of biochemical markers||percent||Standard Error|Mean
700802|NCT00051558|Secondary|Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Bone-Specific Alkaline Phosphatase||1, 6, 18, and 36 months|Subset of patients with measures of biochemical markers||percent||Standard Error|Mean
700803|NCT00051558|Secondary|Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum C-terminal Propeptide of Type 1 Procollagen||1, 6, 18, and 36 months|Subset of patients with measures of biochemical markers.||percent||Standard Error|Mean
700807|NCT00051558|Secondary|Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined|change from baseline in bone mineral density of the total hip as assessed by dual energy X-ray absorptiometry (DXA)|18, 24, 36 months, and 18 and 36 month endpoints|The intention-to-treat analysis was performed using all randomized and treated patients. For 18, 24 and 36 month time points, no missing data were imputed. However, at 18 and 36 month endpoints, last observation carried forward analyses were applied.||grams per square centimeters||Standard Error|Least Squares Mean
700808|NCT00051558|Secondary|Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined|change from baseline in bone mineral density of the femoral neck as assessed by dual energy X-ray absorptiometry (DXA)|18, 24, 36 months, and 18 and 36 month endpoints|The intention-to-treat analysis was performed using all randomized and treated patients. For 18, 24 and 36 month time points, no missing data were imputed. However at the 36 month endpoint, last observation carried forward analysis was applied.||grams per square centimeters||Standard Error|Least Squares Mean
700809|NCT00051558|Secondary|Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined|change from baseline in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)|24 and 36 months and Endpoint at 36 months|The intention-to-treat analysis was performed using all randomized and treated patients. For 24 and 36 month time points, no missing data were imputed. However, at the 36 month endpoint, last observation carried forward analysis was applied.||grams per square centimeters||Standard Error|Least Squares Mean
700810|NCT00051558|Secondary|Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Female Subset|change from baseline in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)|3, 6, 12, and 18 months|The intention-to-treat analysis was performed using all randomized and treated patients. No missing data were imputed.||grams per square centimeters||Standard Error|Least Squares Mean
700811|NCT00051558|Secondary|Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined|change from baseline in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)|3, 6, 12, 18, 24, 36 months|The intention-to-treat analysis was performed using all randomized and treated patients. No missing data were imputed.||grams per square centimeters||Standard Error|Least Squares Mean
700812|NCT00051558|Secondary|Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD), Female Subset|change from baseline at endpoint in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)|18 month endpoint|The intention-to-treat analysis was performed using all randomized and treated patients (female only subset).||grams per square centimeters||Standard Error|Least Squares Mean
700813|NCT00051558|Primary|Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD)|change from baseline at endpoint in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)|18 month endpoint|The intention-to-treat analysis was performed using all randomized and treated patients.||grams per square centimeters||Standard Error|Least Squares Mean
700814|NCT00051636|Secondary|Number of Participants With a Disease Relapse During the Extended Observation Period|Extended observation period. A disease relapse was defined as the occurrence of a serum alkaline phosphatase level that was >= 80% of baseline serum alkaline phosphatase value.|8 years was the maximum|Extended modified Intent-to-treat population: patients who had at least one serum alkaline phosphatase measurement during the extension period.||Participants|||Number
700815|NCT00051636|Secondary|Number of Participants With a Partial Disease Relapse During the Extended Observation Period|Extended observation period. A partial disease relapse was defined as an increase in serum alkaline phosphatase >= 50% from the serum alkaline phosphatase measurement at month 6 and at least 1.25 times the upper normal limit.|8 years was the maximum|Extended modified Intent-to-treat population: patients who had at least one serum alkaline phosphatase measurement during the extension period.||Participants|||Number
700816|NCT00051636|Secondary|Number of Participants With a Loss of Therapeutic Response During the Extended Observation Period|Extended observation period. A therapeutic response is defined as a reduction of at least 75% from baseline in serum alkaline phosphatase excess or normalization of serum alkaline phosphatase.|8 years was the maximum|Extended modified Intent-to-treat population: patients who had at least one serum alkaline phosphatase measurement during the extension period.||Participants|||Number
700817|NCT00051636|Secondary|Change in Pain Interference Score|Change in pain interference score from Brief Pain Inventory-Short Form (BPI-SF). This scale values are 0 to 10, a lower score means little to no pain while a higher score means greater pain.|Baseline and day 182|Intent-to-treat population: all randomized patients. Participants with observations at baseline and day 182 were included in this analysis.||Units on a scale||Standard Deviation|Mean
700818|NCT00051636|Secondary|Change in Pain Severity Score|Change in pain severity score from Brief Pain Inventory-Short Form (BPI-SF). This scale values are 0 to 10, a lower score means little to no pain while a higher score means greater pain.|Baseline and day 182|Intent-to-treat population: all randomized patients. Participants with observations at baseline and day 182 were included in this analysis.||Units on a scale||Standard Deviation|Mean
700819|NCT00051636|Secondary|Number of Patients Who Achieved Serum Alkaline Phosphatase Normalization at Day 28 Relative to Baseline|Normalization of serum alkaline phosphatase occurred if the serum alkaline phosphatase measurement fell within the normal range.|Baseline and day 28|Intent-to-treat population: all randomized patients. Participants with observations at day 28 were included in this analysis.||Participants|||Number
700820|NCT00051636|Secondary|Time to First Therapeutic Response|A therapeutic response was defined as a reduction of at least 75% from baseline (Visit 1) in serum alkaline phosphatase excess (difference between measured level and midpoint to the normal range) or normalization of serum alkaline phosphatase.|182 days|Intent-to-treat population: all randomized patients.||Days||Inter-Quartile Range|Median
700821|NCT00051636|Secondary|Relative Change in Urine Alpha C-telopeptide (α-CTx) in ug/mmol at Day 10|The percent change in urine alpha C-telopeptide from baseline to day 10 was measured.|Baseline and day 10|Intent-to-treat population: all randomized patients. Participants with observations at baseline and day 10 were included in this analysis.||Percent change||Standard Deviation|Mean
700822|NCT00051636|Secondary|Relative Change in Serum C-telopeptide (CTx) in ng/mL at Day 10|The percent change in serum C-telopeptide from baseline to day 10 was measured.|Baseline and day 10|Intent-to-treat population: all randomized patients. Participants with observations at baseline and day 10 were included in this analysis.||percent change||Standard Deviation|Mean
700824|NCT00051636|Primary|Number of Patients Who Achieve Therapeutic Response at 6 Months.|Therapeutic response is defined as a reduction of at least 75% from baseline (Visit 1) in total serum alkaline phosphatase excess (difference between measured level and midpoint to the normal range) or normalization of serum alkaline phosphatase at the end of six months.|6 months|Modified intent to treat population: all randomized patients with both baseline and at least one post-baseline serum alkaline phosphatase measurement. Missing values at 6 months were imputed using the last post-baseline measurement prior to 6 months.||participants|||Number
700825|NCT00052078|Primary|Clinical Global Impression - Improvement Scale|The Clinical Global Impression – Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1-Very much improved; 2-Much improved; 3-Minimally improved; 4-No change; 5-Minimally worse; 6-Much worse; 7-Very much worse. Response rates are reported as a percentage of participants who score 1-Very much improved; 2-Much improved on the The Clinical Global Impression – Improvement scale.|Measured at Week 12|||percentage of participants||95% Confidence Interval|Number
700826|NCT00052429|Primary|Local Control of Participants|Patients will be classified as controlled as long as there is no clinical or radiographic evidence of disease progression. Physical exam with fiberoptic nasopharyngoscopy will be performed approximately every 3 months in the first year of follow-up, every 4 months in the second year, every 6 months in the third-fifth years and annually, thereafter.|every 3 months in the first year of follow-up, every 4 months in the second year, every 6 months in the third-fifth years and annually, thereafter.|||percentage of participants|||Number
700827|NCT00052429|Primary|Survival Rate of Patients|Patients will be followed indefinitely and will have standard screening for development of distant metastases, including physical exam, as well as liver function tests and a chest radiograph annually. Patients will be classified as progression free as long as they remain alive with local, regional or distant recurrence.|up to 77 months|||months||Full Range|Median
700828|NCT00052715|Secondary|To Determine Tumor Response|Due to the reports of transient enlargement of contrast enhancing disease with subsequent shrinkage during Poly-ICLC treatment and the lack of central radiological review, the protocol defined criteria for radiological response could not be employed because of the risk of inconsistent results|2 years||||||
700829|NCT00052715|Secondary|To Determine the Change in Neurological Status in Patients With Glioblastoma Treated With External Beam Radiotherapy and Poly-ICLC|This was to be a descriptive measure per investigator, however, due to the reports of premature discontinuation of study agent in response to what turned out to be pseudo-progression, that outcome was not assessed.|1 year||||||
700830|NCT00052715|Secondary|to Determine Grade 3 and 4 Toxicities Associated With Poly-ICLC in Newly Diagnosed Patients|CTCAE 4|2 years|||participants|||Number
700831|NCT00052715|Secondary|Determine the 12-month Survival Rate|12-month survival rate calculated from date of diagnosis|1 year|||percent of participants|||Number
700832|NCT00052715|Secondary|To Determine 6 Months Progression Free Survival|Patients evaluated from date of diagnosis to the 6 month scan|6 months|||percentage of participants|||Number
700833|NCT00052715|Primary|Overall Survival in Pts With Newly Diagnosed GBM|Overall survival from surgical diagnosis in patients with Newly Diagnosed GBM|total survival from surgical diagnosis|Four patents were censored for survival at 35, 114, 126, and 166 weeks||weeks||95% Confidence Interval|Median
700834|NCT00052962|Secondary|Number of Participants With an Adverse Event|Here is the number of participants with an adverse event. For a detailed list of adverse events see the adverse event module.|2003-2008|Three participants were not included in the analysis because one participant was not randomized/not evaluable, two were not evaluable, and/or information is not known.||Participants|||Number
700835|NCT00052962|Primary|Progression Free Survival|"CHPP is administered as a heated cisplatin solution delivered to the abdomen through a catheter (plastic tube), washed through the abdomen for 90 minutes, and then drained out of the body through another catheter.
Progression is defined as imageable tumor nodules or increasing ascites persistent on two serial computed tomography (CT) scans."|2003-2008|Study was closed July 2008 because the PI left the institution, thus the objective was not met.|||||
700836|NCT00053014|Secondary|Serious Adverse Events|Twice a week for the first two months, one time a week during month 3, one time every two weeks for months 4-9.|9 months|All patients||participants|||Number
700837|NCT00053014|Primary|Overall Survival|measured from date of registration to study until death from any cause with patients still alive censored at date of last contact|1 year|||participants|||Number
700840|NCT00044512|Secondary|Overall Survival|Time from the first date of receiving study medication to death.|Start of treatment to death|Intention to Treat (ITT) analyses were performed on all treated subjects and for subgroups such as baseline Child Pugh status (A vs B), ECOG PS (0 vs 1), TNM stage at study entry (II/III vs IV), hepatitis B and hepatitis C status (positive vs negative).||days||95% Confidence Interval|Median
700841|NCT00044512|Secondary|Duration of Minor Response|Time from the date that MR was first documented to the date that PD was first documented.|Time from MR to PD|Intention to Treat (ITT) analyses were performed on all treated subjects and for subgroups such as baseline Child Pugh status (A vs B), ECOG PS (0 vs 1), TNM stage at study entry (II/III vs IV), hepatitis B and hepatitis C status (positive vs negative).||days||Full Range|Mean
700842|NCT00044512|Secondary|Time to Minor Response|Time from the first day of receiving study drug to the date the MR was first documented (with confirmation). Minor response = >25% regression.|up to 3 years later|Intention to Treat (ITT) analyses were performed on all treated subjects and for subgroups such as baseline Child Pugh status (A vs B), ECOG PS (0 vs 1), TNM stage at study entry (II/III vs IV), hepatitis B and hepatitis C status (positive vs negative).||days||95% Confidence Interval|Median
700845|NCT00044512|Secondary|Time to Response|Time from the first day of receiving study drug to the date the CR or PR was documented (with confirmation).|up to 3 years later|Intention to Treat (ITT) analyses were performed on all treated subjects and for subgroups such as baseline Child Pugh status (A vs B), ECOG PS (0 vs 1), TNM stage at study entry (II/III vs IV), hepatitis B and hepatitis C status (positive vs negative).||days||95% Confidence Interval|Median
700846|NCT00044512|Secondary|Duration of Response|Duration of response was calculated from the first drug treatment date until documented progressive disease (PD). PD was 1) 25% or more increase in the sum of all target lesion areas taking as reference the smallest sum recorded at or following baseline, 2) unequivocal progression of an existing non-target lesion, or 3) appearance of a new lesion.|up to 3 years later|Intention to Treat (ITT) analyses were performed on all treated subjects and for subgroups baseline Child Pugh status (A vs B), ECOG PS (0 vs 1), TNM stage at study entry (II/III vs IV), hepatitis B and C status (positive vs negative). The 3 subjects are censored at time of evaluation. The Median is not estimable so the reported number is biased.||days||Full Range|Median
700847|NCT00044512|Primary|Percentage of Participants for Each Type of Response|Objective response rate of sorafenib assessed as the proportion of subjects with confirmed complete or partial response as per modified World Health Organization (WHO) criteria.|Until 30 days after termination of active therapy|Intention to Treat (ITT) analyses were performed on subgroups of patients categorized by baseline characteristics of ECOG Performance Status, Child Pugh status, TNM stage at study entry, prior surgical procedure, hepatitis A and B status, and age.||percentage of participants|||Number
700848|NCT00044655|Secondary|Psychiatric Symptoms, Hospitalization, and Medication Side Effects||Measured at Year 1||||||
700849|NCT00044655|Primary|Number Who Discontinued Medication Within First 6 Study Months||Measured at Six Months|intent to treat samples for 2 substudies: injectable to injectable and polypharmacy to monotherapy||participants|||Number
700850|NCT00045032|Secondary|Percentage of Participants With Secondary Cardiac Endpoint Events Compared to Observation: 10-Year Maximum Follow-Up|Secondary cardiac endpoint events included NYHA Class I or II CHF with a drop in LVEF measured by multiple-gated acquisition or electrocardiogram, unless the subsequent assessment of LVEF indicated a return to levels that did not meet the definition of a significant LVEF drop. A significant LVEF drop was defined as an absolute reduction of at least 10 percentage points from Baseline and to a value <50%. The percentage of participants with at least one secondary cardiac endpoint event was reported, excluding those with both a primary and secondary cardiac endpoint event. The 95% CI was calculated by the Pearson-Clopper method for a one-sample binomial.|From Baseline until time of event (maximum up to 10 years)|Safety Population||percentage of participants||95% Confidence Interval|Number
700851|NCT00045032|Secondary|Percentage of Participants With Primary Cardiac Endpoint Events Compared to Observation: 10-Year Maximum Follow-Up|Primary cardiac endpoint events included the occurrence of any of the following between randomization and new therapy for recurrent disease: symptomatic New York Heart Association (NYHA) Class III or IV congestive heart failure (CHF) confirmed by a cardiologist with a drop in left ventricular ejection fraction (LVEF) at least 10 percentage points from Baseline and to a value less than (<) 50%, and documentation of definite or probable cardiac death. Definite cardiac death included CHF, myocardial infarction, or primary arrhythmia. Probable cardiac death included unexpected sudden death within 24 hours of a cardiac event (syncope, cardiac arrest, chest pain, infarction, arrhythmia) without documented etiology. The percentage of participants with at least one primary cardiac endpoint event was reported. The 95% CI was calculated by the Pearson-Clopper method for a one-sample binomial.|From Baseline until time of event (maximum up to 10 years)|Safety Population: All participants randomized/enrolled in the study according to actual treatment received. Hence, participants assigned to Herceptin who received no study treatment were analyzed in the Observation Arm.||percentage of participants||95% Confidence Interval|Number
700852|NCT00045032|Secondary|RDFS Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up|RDFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer, or death from any cause. The percentage of participants free of RDFS events (i.e., the RDFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.|Years 3, 5, 7, 8|FAS Population 1Y2Y. In contrast to other study endpoints, RDFS compared to the Observation Arm was not a planned endpoint according to study protocol. Only RDFS in Herceptin 1-Year Arm versus Herceptin 2-Year Arm was a planned endpoint.||percentage of participants||95% Confidence Interval|Number
700853|NCT00045032|Secondary|Percentage of Participants With Restricted Disease-Free Survival (RDFS) Events in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up|RDFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer, or death from any cause. The percentage of participants with at least one RDFS event was reported.|From Baseline until time of event (median of 8 years)|FAS Population 1Y2Y. In contrast to other study endpoints, RDFS compared to the Observation Arm was not a planned endpoint according to study protocol. Only RDFS in Herceptin 1-Year Arm versus Herceptin 2-Year Arm was a planned endpoint.||percentage of participants|||Number
700854|NCT00045032|Secondary|DTR-Free Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up|The percentage of participants without DTR (i.e., the DTR-free rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis. DTR included distant tumors ignoring local and regional recurrences, contralateral breast cancer, and second non-breast malignancy.|Years 3, 5, 7, 8|FAS Population 1Y2Y||percentage of participants||95% Confidence Interval|Number
700855|NCT00045032|Secondary|Percentage of Participants With DTR in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up|The percentage of participants with DTR was reported. DTR included distant tumors ignoring local and regional recurrences, contralateral breast cancer, and second non-breast malignancy.|From Baseline until time of event (median of 8 years)|FAS Population 1Y2Y||percentage of participants|||Number
700856|NCT00045032|Secondary|DTR-Free Rate According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up|The percentage of participants without DTR (i.e., the DTR-free rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis. DTR included distant tumors ignoring local and regional recurrences, contralateral breast cancer, and second non-breast malignancy.|Years 3, 5, 7, 8|FAS Population||percentage of participants||95% Confidence Interval|Number
700858|NCT00045032|Secondary|TR-Free Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up|The percentage of participants without TR of the present breast cancer (i.e., the TR-free rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis. TR included local, regional, or distant tumor ignoring contralateral breast cancer and second non-breast malignancy.|Years 3, 5, 7, 8|FAS Population 1Y2Y||percentage of participants||95% Confidence Interval|Number
700859|NCT00045032|Secondary|Percentage of Participants With TR in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up|The percentage of participants with TR of the present breast cancer was reported. TR included local, regional, or distant tumor ignoring contralateral breast cancer and second non-breast malignancy.|From Baseline until time of event (median of 8 years)|FAS Population 1Y2Y||percentage of participants|||Number
700860|NCT00045032|Secondary|TR-Free Rate According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up|The percentage of participants without TR of the present breast cancer (i.e., the TR-free rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis. TR included local, regional, or distant tumor ignoring contralateral breast cancer and second non-breast malignancy.|Years 3, 5, 7, 8|FAS Population||percentage of participants||95% Confidence Interval|Number
700861|NCT00045032|Secondary|Percentage of Participants With Tumor Recurrence (TR) Compared to Observation: 8-Year Median Follow-Up|The percentage of participants with TR of the present breast cancer was reported. TR included local, regional, or distant tumor ignoring contralateral breast cancer and second non-breast malignancy.|From Baseline until time of event (median of 8 years)|FAS Population||percentage of participants|||Number
700862|NCT00045032|Secondary|DDFS Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up|DDFS events included distant tumor recurrence, second primary cancer, or contralateral breast cancer. The percentage of participants free of DDFS events (i.e., the DDFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.|Years 3, 5, 7, 8|FAS Population 1Y2Y||percentage of participants||95% Confidence Interval|Number
700863|NCT00045032|Secondary|Percentage of Participants With DDFS Events in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up|DDFS events included distant tumor recurrence, second primary cancer, or contralateral breast cancer. The percentage of participants with at least one DDFS event was reported.|From Baseline until time of event (median of 8 years)|FAS Population 1Y2Y||percentage of participants|||Number
700864|NCT00045032|Secondary|DDFS Rate According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up|DDFS events included distant tumor recurrence, second primary cancer, or contralateral breast cancer. The percentage of participants free of DDFS events (i.e., the DDFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.|Years 3, 5, 7, 8|FAS Population||percentage of participants||95% Confidence Interval|Number
700865|NCT00045032|Secondary|Percentage of Participants With Distant Disease-Free Survival (DDFS) Events Compared to Observation: 8-Year Median Follow-Up|DDFS events included distant tumor recurrence, second primary cancer, or contralateral breast cancer. The percentage of participants with at least one DDFS event was reported.|From Baseline until time of event (median of 8 years)|FAS Population||percentage of participants|||Number
700866|NCT00045032|Secondary|RFS Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up|RFS events included local, regional, or distant tumor recurrence. The percentage of participants free of RFS events (i.e., the RFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.|Years 3, 5, 7, 8|FAS Population 1Y2Y||percentage of participants||95% Confidence Interval|Number
700867|NCT00045032|Secondary|Percentage of Participants With RFS Events in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up|RFS events included local, regional, or distant tumor recurrence. The percentage of participants with at least one RFS event was reported.|From Baseline until time of event (median of 8 years)|FAS Population 1Y2Y||percentage of participants|||Number
700868|NCT00045032|Secondary|RFS Rate According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up|RFS events included local, regional, or distant tumor recurrence. The percentage of participants free of RFS events (i.e., the RFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.|Years 3, 5, 7, 8|FAS Population||percentage of participants||95% Confidence Interval|Number
700869|NCT00045032|Secondary|Percentage of Participants With Recurrence-Free Survival (RFS) Events Compared to Observation: 8-Year Median Follow-Up|RFS events included local, regional, or distant tumor recurrence. The percentage of participants with at least one RFS event was reported.|From Baseline until time of event (median of 8 years)|FAS Population||percentage of participants|||Number
700870|NCT00045032|Secondary|OS Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 11-Year Median Follow-Up|OS events referred to death from any cause. The percentage of participants alive (i.e., the OS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with an 11-year median follow-up for OS events.|Years 3, 5, 7, 9, 10, 11, 12|FAS Population 1Y2Y||percentage of participants||95% Confidence Interval|Number
700871|NCT00045032|Secondary|Percentage of Participants With OS Events in 1-Year Versus 2-Year Herceptin: 11-Year Median Follow-Up|OS events referred to death from any cause. The percentage of participants who died was reported.|From Baseline until time of event (median of 11 years)|FAS Population 1Y2Y||percentage of participants|||Number
700872|NCT00045032|Secondary|OS Rate According to Kaplan-Meier Analysis Compared to Observation: 11-Year Median Follow-Up|OS events referred to death from any cause. The percentage of participants alive (i.e., the OS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with an 11-year median follow-up for OS events.|Years 3, 5, 7, 9, 10, 11, 12|FAS Population||percentage of participants||95% Confidence Interval|Number
700873|NCT00045032|Secondary|Percentage of Participants With OS Events Compared to Observation: 11-Year Median Follow-Up|OS events referred to death from any cause. The percentage of participants who died was reported.|From Baseline until time of event (median of 11 years)|FAS Population||percentage of participants|||Number
700874|NCT00045032|Secondary|OS Rate According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up|OS events referred to death from any cause. The percentage of participants alive (i.e., the OS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.|Years 3, 5, 7, 8|FAS Population||percentage of participants||95% Confidence Interval|Number
700875|NCT00045032|Secondary|Percentage of Participants With OS Events Compared to Observation: 8-Year Median Follow-Up|OS events referred to death from any cause. The percentage of participants who died was reported.|From Baseline until time of event (median of 8 years)|FAS Population||percentage of participants|||Number
700876|NCT00045032|Secondary|OS Rate According to Kaplan-Meier Analysis in Herceptin 2-Year Arm Compared to Observation: 1-Year Median Follow-Up|OS events referred to death from any cause. The percentage of participants alive (i.e., the OS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 1-year median follow-up analysis. The analysis of the Herceptin 2-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed for an IDMC in 2005 at a time the Sponsor was blinded. The analysis of the Herceptin 1-Year Arm against the Observation Arm was performed by the Sponsor in 2006 following database cleaning. Therefore, these data are reported under a separate Outcome Measure.|Year 2|"FAS Population. The Number of Participants Analyzed reflects the number with data for the endpoint."||percentage of participants||95% Confidence Interval|Number
700877|NCT00045032|Secondary|OS Rate According to Kaplan-Meier Analysis in Herceptin 1-Year Arm Compared to Observation: 1-Year Median Follow-Up|OS events referred to death from any cause. The percentage of participants alive (i.e., the OS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 1-year median follow-up analysis. The analysis of the Herceptin 1-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed by the Sponsor in 2006 following database cleaning. The analysis of the Herceptin 2-Year Arm against the Observation Arm was performed for an IDMC in 2005 at a time the Sponsor was blinded. Therefore, these data are reported under a separate Outcome Measure.|Year 2|"FAS Population. The Number of Participants Analyzed reflects the number with data for the endpoint."||percentage of participants||95% Confidence Interval|Number
700878|NCT00045032|Secondary|Percentage of Participants With OS Events in Herceptin 2-Year Arm Compared to Observation: 1-Year Median Follow-Up|OS events referred to death from any cause. The percentage of participants who died was reported. The analysis of the Herceptin 2-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed for an IDMC in 2005 at a time the Sponsor was blinded. The analysis of the Herceptin 1-Year Arm against the Observation Arm was performed by the Sponsor in 2006 following database cleaning. Therefore, these data are reported under a separate Outcome Measure.|From Baseline until time of event (median of 1 year)|"FAS Population. The Number of Participants Analyzed reflects the number with data for the endpoint."||percentage of participants|||Number
700879|NCT00045032|Secondary|Percentage of Participants With Overall Survival (OS) Events in Herceptin 1-Year Arm Compared to Observation: 1-Year Median Follow-Up|OS events referred to death from any cause. The percentage of participants who died was reported. The analysis of the Herceptin 1-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed by the Sponsor in 2006 following database cleaning. The analysis of the Herceptin 2-Year Arm against the Observation Arm was performed for an IDMC in 2005 at a time the Sponsor was blinded. Therefore, these data are reported under a separate Outcome Measure.|From Baseline until time of event (median of 1 year)|"FAS Population. The Number of Participants Analyzed reflects the number with data for the endpoint."||percentage of participants|||Number
700880|NCT00045032|Secondary|DFS Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 10-Year Maximum Follow-Up|DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with a 10-year maximum follow-up for DFS events.|Years 3, 5, 7, 8, 9, 10|FAS Population 1Y2Y||percentage of participants||95% Confidence Interval|Number
700881|NCT00045032|Secondary|Percentage of Participants With DFS Events in 1-Year Versus 2-Year Herceptin: 10-Year Maximum Follow-Up|DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants with at least one DFS event was reported.|From Baseline until time of event (maximum of 10 years)|FAS Population 1-Year Herceptin Versus 2-Year Herceptin (1Y2Y): Participants without a DFS event and still under follow-up at the pre-defined landmark of 366 days after randomization, analyzed when intent-to-treat principle was applied for comparison of 1 year versus 2 years of Herceptin.||percentage of participants|||Number
700882|NCT00045032|Primary|DFS Rate at Year 10 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up|DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with a 10-year maximum follow-up for DFS events.|Year 10|FAS Population||percentage of participants||95% Confidence Interval|Number
700883|NCT00045032|Primary|DFS Rate at Year 9 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up|DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with a 10-year maximum follow-up for DFS events.|Year 9|FAS Population||percentage of participants||95% Confidence Interval|Number
700906|NCT00045110|Secondary|Peak Plasma Concentration Per Dose Level Phase I (on Anticonvulsants) -|plasma concentrations relative to erlotiniab administration and sample time and dose level|baseline, 1,2,4,6,8,12,24h post administration day 1 cycle 1. One sample on day 8 cycle 1 and day 1 of cycle 2,3 and 5|Cp=peak plasma concentration;||ng/mL||Standard Deviation|Mean
700884|NCT00045032|Primary|DFS Rate at Year 8 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up|DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with a 10-year maximum follow-up for DFS events.|Year 8|FAS Population||percentage of participants||95% Confidence Interval|Number
700885|NCT00045032|Primary|DFS Rate at Year 7 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up|DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with a 10-year maximum follow-up for DFS events.|Year 7|FAS Population||percentage of participants||95% Confidence Interval|Number
700886|NCT00045032|Primary|DFS Rate at Year 5 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up|DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with a 10-year maximum follow-up for DFS events.|Year 5|FAS Population||percentage of participants||95% Confidence Interval|Number
700887|NCT00045032|Primary|DFS Rate at Year 3 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up|DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with a 10-year maximum follow-up for DFS events.|Year 3|FAS Population||percentage of participants||95% Confidence Interval|Number
700888|NCT00045032|Primary|Percentage of Participants With DFS Events Compared to Observation: 10-Year Maximum Follow-Up|DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants with at least one DFS event was reported.|From Baseline until time of event (maximum of 10 years)|FAS Population||percentage of participants|||Number
700889|NCT00045032|Primary|DFS Rate at Year 8 According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up|DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.|Year 8|FAS Population||percentage of participants||95% Confidence Interval|Number
700890|NCT00045032|Primary|DFS Rate at Year 7 According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up|DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.|Year 7|FAS Population||percentage of participants||95% Confidence Interval|Number
700891|NCT00045032|Primary|DFS Rate at Year 5 According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up|DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.|Year 5|FAS Population||percentage of participants||95% Confidence Interval|Number
700892|NCT00045032|Primary|DFS Rate at Year 3 According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up|DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.|Year 3|FAS Population||percentage of participants||95% Confidence Interval|Number
700893|NCT00045032|Primary|Percentage of Participants With DFS Events Compared to Observation: 8-Year Median Follow-Up|DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants with at least one DFS event was reported.|From Baseline until time of event (median of 8 years)|FAS Population||percentage of participants|||Number
700907|NCT00045110|Secondary|Time of Peak Plasma Concentration Per Dose Level Phase I (on Anticonvulsants) -|plasma concentrations relative to erlotiniab administration and sample time and dose level|baseline, 1,2,4,6,8,12,24h post administration day 1 cycle 1.|tmax=time of peak plasma concentration||h||Standard Deviation|Mean
700908|NCT00045110|Secondary|Percent of Patients With One or More Grade 3-5 Toxicity Described Based on the CTC Severity Grading Phase II|Summarized by descriptive statistics.|Up to 1 year|drug related events grade 3-5 CTCAE. 5 patients were not evaluable for response/toxicity.||percent of participants|||Number
701555|NCT00054665|Primary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|43 months|||Participants|||Number
700894|NCT00045032|Primary|DFS Rate According to Kaplan-Meier Analysis in Herceptin 2-Year Arm Compared to Observation: 1-Year Median Follow-Up|DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 1-year median follow-up analysis. The analysis of the Herceptin 2-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed for an IDMC in 2005 at a time the Sponsor was blinded. The analysis of the Herceptin 1-Year Arm against the Observation Arm was performed by the Sponsor in 2006 following database cleaning. Therefore, these data are reported under a separate Outcome Measure.|Year 2|"FAS Population. The Number of Participants Analyzed reflects the number with data for the endpoint."||percentage of participants||95% Confidence Interval|Number
700895|NCT00045032|Primary|DFS Rate According to Kaplan-Meier Analysis in Herceptin 1-Year Arm Compared to Observation: 1-Year Median Follow-Up|DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95 percent (%) confidence interval (CI) were estimated by Kaplan-Meier analysis based on available data at the time of the 1-year median follow-up analysis. The analysis of the Herceptin 1-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed by the Sponsor in 2006 following database cleaning. The analysis of the Herceptin 2-Year Arm against the Observation Arm was performed for an IDMC in 2005 at a time the Sponsor was blinded. Therefore, these data are reported under a separate Outcome Measure.|Year 2|"FAS Population. The Number of Participants Analyzed reflects the number with data for the endpoint."||percentage of participants||95% Confidence Interval|Number
700896|NCT00045032|Primary|Percentage of Participants With DFS Events in Herceptin 2-Year Arm Compared to Observation: 1-Year Median Follow-Up|DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants with at least one DFS event was reported. The analysis of the Herceptin 2-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed for an IDMC in 2005 at a time the Sponsor was blinded. The analysis of the Herceptin 1-Year Arm against the Observation Arm was performed by the Sponsor in 2006 following database cleaning. Therefore, these data are reported under a separate Outcome Measure.|From Baseline until time of event (median of 1 year)|"FAS Population. The Number of Participants Analyzed reflects the number with data for the endpoint."||percentage of participants|||Number
700897|NCT00045032|Primary|Percentage of Participants With Disease-Free Survival (DFS) Events in Herceptin 1-Year Arm Compared to Observation: 1-Year Median Follow-Up|DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants with at least one DFS event was reported. The analysis of the Herceptin 1-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed by the Sponsor in 2006 following database cleaning. The analysis of the Herceptin 2-Year Arm against the Observation Arm was performed for an Independent Data Monitoring Committee (IDMC) in 2005 at a time the Sponsor was blinded. Therefore, these data are reported under a separate Outcome Measure.|From Baseline until time of event (median of 1 year)|"FAS Population. The Number of Participants Analyzed reflects the number with data for the endpoint."||percentage of participants|||Number
700898|NCT00045110|Secondary|Pharmacokinetics (Tissue) Level for Recurrent Patients Not on Enzyme-inducing Antiepileptic Drugs|Drug administered 6 days prior to surgery|Pre-surgery and time of resection|sample 5 and 6 suspected of contamination with blood clot tumor/tissue concentration||tumor/tissue concentration ng/g dry weig||Standard Deviation|Mean
700899|NCT00045110|Secondary|Pharmacokinetics (Plasma) Level for Recurrent Patients Not on Enzyme-inducing Antiepileptic Drugs|Drug administered 6 days prior to surgery|Pre-surgery and time of resection|sample 5 and 6 suspected of contamination with blood clot||plasma concentration ng/mL||Standard Deviation|Mean
700900|NCT00045110|Secondary|Trough Level for Recurrent Patients Not on Enzyme-inducing Antiepileptic Drugs - Phase 2 - Dose 150mg -|plasma concentrations relative to erlotiniab administration and sample time and dose level|One sample on day 8 cycle 1|Cp=peak plasma concentration; tmax=time to Cp; AUC=area under the curve;||ng/mL||Standard Deviation|Mean
700901|NCT00045110|Secondary|Estimation of Area Under the Curve for Recurrent Patients Not on Enzyme-inducing Antiepileptic Drugs - Phase 2 - Dose 150mg-|plasma concentrations relative to erlotiniab administration and sample time and dose level|baseline, 1,2,4,6,8,12,24h post administration day 1 cycle 1. One sample on day 8 cycle 1 and day 1 of cycle 2,3 and 5|AUC=area under the curve;||ug * h/mL||Standard Deviation|Mean
700902|NCT00045110|Secondary|Time to Peak Plasma Concentration for Recurrent Patients Not on Enzyme-inducing Antiepileptic Drugs - Phase 2 - Dose 150mg -|plasma concentrations relative to erlotiniab administration and sample time and dose level|baseline, 1,2,4,6,8,12,24h post administration day 1 cycle 1. One sample on day 8 cycle 1 and day 1 of cycle 2,3 and 5|tmax=time to peak plasma concentration;||h||Standard Deviation|Mean
700903|NCT00045110|Secondary|Peak Plasma Concentration Level for Recurrent Patients Not on Enzyme-inducing Antiepileptic Drugs - Phase 2 - Dose 150mg -|plasma concentrations relative to erlotiniab administration and sample time and dose level|baseline, 1,2,4,6,8,12,24h post administration day 1 cycle 1. One sample on day 8 cycle 1 and day 1 of cycle 2,3 and 5|Cpmax =peak plasma concentration;||ng/mL||Standard Deviation|Mean
700904|NCT00045110|Secondary|Trough Level Per Dose Level Phase I (on Anticonvulsants) -|plasma concentrations relative to erlotiniab administration and sample time and dose level|cycle 1 day eight|trough level||ng/mL||Standard Deviation|Mean
700905|NCT00045110|Secondary|Estimation of the Area Under the Curve Per Dose Level Phase I (on Anticonvulsants) -|plasma concentrations relative to erlotiniab administration and sample time and dose level|baseline, 1,2,4,6,8,12,24h post administration day 1 cycle 1. One sample on day 8 cycle 1 and day 1 of cycle 2,3 and 5|AUC=area under the curve||ug* h/mL||Standard Deviation|Mean
701616|NCT00054717|Secondary|Median Change From Baseline in Viral Load to Week 16||Baseline to Week 16|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Log(Copies/mL)||Inter-Quartile Range|Median
700909|NCT00045110|Secondary|Response Rate (Complete or Partial Response) Graded Using Modified RECIST Criteria Phase II|"Measurable: Bidimensionally measurable lesions w/ clearly defined margins by MRI
Evaluable: Unidimensionally measurable lesions, masses w/margins not clearly defined.
Complete Response (CR): Complete disappearance of all measurable/evaluable disease. No new lesions. No evidence of non-evaluable disease. Patients on minimal/no steroids.
Partial Response (PR): >/= to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. Responders must be on same/decreasing doses of dexamethasone.
Stable/No Response: Does not qualify for CR, PR, or progression.
Progression: 25% increase in the sum of products of all measurable lesions over smallest sum observed (over BL if no decrease), OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer)."|At 1 year|recurrent malignant gliomas - anaplastic and glioblastoma||participants|||Number
700910|NCT00045110|Secondary|Overall Survival Newly Diagnosed GBM Post RT|Overall Survival defined as Time from Start of treatment to time of death due to any cause|2 years|not receiving Enzyme-inducing Antiepileptic Drugs, glioblastoma stable after RT||months||95% Confidence Interval|Median
700911|NCT00045110|Secondary|1 Year Survival - Phase II Newly Diagnosed GBM Post RT|12 month survival for newly diagnosed stable GBM post RT treated with erlotinib post RT|At 1 year|not receiving Enzyme-inducing Antiepileptic Drugs; stable glioblastoma after RT||% of participants|||Number
700912|NCT00045110|Secondary|Percent of Participants With a Grade 3 or 4 Adverse Events Phase 1|CTCAE|1 year|During Cycle 1 only grade 3 severity; patients on Enzyme-inducing Antiepileptic Drugs||Participants|||Count of Participants
700913|NCT00045110|Primary|6 Months Progression-free Survival in Recurrent Malignant Gliomas (Phase II)|Progression: 25% increase in the sum of products of all measurable lesions over smallest sum observed (over BL if no decrease), OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).|6 months|38 Glioblastoma, 15 anaplastic gliomas not receiving Enzyme-inducing Antiepileptic Drugs||Participants|||Count of Participants
700914|NCT00045110|Primary|Define Maximum Tolerated Dose (MTD) of Erlotinib by Phase 1 Cohorts|standard 3+3 dose escalation design 3 patients in each dose level, observed for 28 days before enrollment to next level. if none of the patients experienced DLT dose escalated, if 1 of 3 experienced DLT 3 more enrolled at that level, if none of the 3 additional pts had DLT escalate to next level, if one or more of the additional pts experienced DLT, the MTD was exceeded and 3 more patients were treated at the next lower dose (if only 3 pts treated at the lower dose). The MTD is the dose at which 0/3 or 1/6 patients have experienced a DLT with the next higher dose having at least 2/3 or 2/6 patients encountering DLT.|cycle 1 - 28 days|Cohorts/dose levels: 150mg; 200mg; 275mg; 400mg; 525mg; 650mg; 775mg patients on Enzyme-inducing Antiepileptic Drugs||mg|||Number
700915|NCT00045110|Primary|Number of Dose Limiting Toxicity (DLT) Each Dose Level Phase I|DLT Definition: any grade 3 thrombocytopenia and grade 4 anemia and neutropenia; any non-hematologic grade 3 toxicity; failure to recover from toxicities to be eligible for re-treatment with erlotinib within 2 weeks of the last dose of erlotinib.|28 days|Patients were eligible if they had recurrent disease or if they were newly diagnosed post RT and did NOT have tumor progression (nonprogression glioblastoma) on Enzyme-inducing Antiepileptic Drugs||dose limiting toxicities|||Number
700916|NCT00045162|Secondary|Number of Patients With a Given Type and Grade of Adverse Event.|Only adverse events that are possibly, probably or definitely related to study drug are reported. Only patients who received protocol treatment and were assessed for adverse events are included.|Every 4 weeks while subject on protocol treatment for a maximum of 12 weeks.|Eligible patients who received protocol treatment.||Participants|||Number
700917|NCT00045162|Secondary|Confirmed and Unconfirmed Complete and Partial Responses.|Patients underwent chest CT/MRI every 6 weeks while on treatment and tumor response was evaluated by RECIST in the subset of patients with at least one target lesion at baseline. A target lesion was defined as a lesion with a longest diameter of at least 2 cm ( or at least 1 cm if by spiral CT). A complete response (CR) was defined as the disappearance of all disease, including non-target lesions. A partial response (PR) was defined as a 30% or greater decrease in the sum of the longest diameters. Confirmation of a CR or PR was defined as a second determination of CR or PR at least 4 weeks after the first determination.|Every 6 weeks while on protocol treatment for a maximum of 12 weeks|||participants|||Number
700918|NCT00045162|Secondary|Progression-free Survival|Progression-Free Survival was defined as the duration from the date of randomization (enrollment) until the date of documentation of progression as defined by RECIST (a 20% increase over nadir in the sum of longest diameters of target lesions, clear progression of a non-target lesion in the opinion of the treating investigator, appearance of new lesions, or symptomatic deterioration) or death due to any cause. Patients last known to be alive and without evidence of progression were censored at the date of last contact.|Every 6 weeks until disease progression or a maximum of 3 years from the date of enrollment.|||months||95% Confidence Interval|Median
700919|NCT00045162|Primary|Overall Survival|Overall survival was defined as the duration between the date of randomization( enrollment) and the date of death due to any cause. Patients last known to be alive were censored at the date of last contact.|Weekly while on treatment, then every 3 months for first year, then every 6 months unitl a maximum of 3 years from enrollment.|||Months||95% Confidence Interval|Median
700920|NCT00045305|Secondary|Time to Engraftment for Platelet|Time to platelet engraftment is defined from date of infusion to date of platelet engraftment. The platelet engraftment is defined as platelets > 20,000 on two consecutive measurements, at least seven days apart, without platelet transfusions in between and for at least three days before the first measurement that is over 20,000. The date of engraftment is the date of the first measurement that is over 20,000.|Daily while hospitalized and then at least 1x/week for the first 50 days and then at least every other week until day 100.|eligible and treated patients||days||95% Confidence Interval|Median
700921|NCT00045305|Secondary|Time to Engraftment for Neutrophil|Time to neutrophil engraftment is defined from date of infusion to date of neutrophil engraftment. Neutrophil engraftment is defined as ANC > 500/mm3 on two consecutive measurements. The date of engraftment is the date of the first ANC > 500/mm3.|Daily while hospitalized and then at least 1x/week for the first 50 days and then at least every other week until day 100.|eligible and treated patients||days||95% Confidence Interval|Median
700922|NCT00045305|Secondary|Proportion of Graft Versus Host Disease|Proportion of Graft versus Host Disease is calculated as number of patients with Graft versus Host Disease divided by all eligible and treated patients|Monthly for the first 3 months from study entry, every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5.|eligible and treated patients||proportion of participants||95% Confidence Interval|Number
700923|NCT00045305|Secondary|Overall Survival|Overall survival (OS) is defined to be the time from registration to death from any cause, with follow-up censored at the date of last contact. Kaplan-Meier method was used to estimate the distribution of OS.|Monthly for the first 3 months from study entry, every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5.|eligible and treated patients||years||95% Confidence Interval|Median
700924|NCT00045305|Secondary|Number of Patients Who Developed Disease Progression After Achieving Complete Response|Disease free survival (DFS) was listed as a secondary endpoint in the study protocol, which would be assessed in patients who achieved complete response (CR). It was defined to be time from CR to documented progression or to death without progression. Patients without documented progression or death reported were censored at the time of last disease evaluation. However, due to the small number of patients with CR, the number of patients who developed disease progression was reported here.|Monthly for the first 3 months from study entry, every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5.|eligible and treated patients who achieved complete response||participants|||Number
700925|NCT00045305|Primary|Complete Response Rate|"Completed response is defined as:
Bone marrow evaluation: Repeat bone marrow showing < 5% myeloblasts with normal maturation of all cell lines, with no evidence for dysplasia (see dysplasia qualifier under peripheral blood evaluation).
Peripheral blood evaluation [absolute values must last at least 2 months] Hemoglobin >11 g/dl (untransfused, not on erythropoietin) Neutrophils (1500/mm3 (not on a myeloid growth factor)) Platelets (100,000/mm3 (not on a thrombopoetic agent)) Blasts - 0% No dysplasia. No detectable cytogenetic abnormality, if preexisting abnormality was present"|Monthly for the first 3 months from study entry, every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5.|eligible and treated patients||percentage of participants||90% Confidence Interval|Number
700926|NCT00045435|Secondary|Incidence of Acute and Chronic GVHD|Percent patients with acute/chronic GVHD|aGVHD: 100 days after transplant; cGVHD: 1 Year after transplant.|||percentage of participants|||Number
700927|NCT00045435|Secondary|Incidence of Rejection|Percent patients who developed infections post-transplant.|By 1 year after transplant|||percentage of participants|||Number
700928|NCT00045435|Secondary|Incidence of Relapse|Percent patients with relapsed disease post-transplant.|By 1 year after transplant|||percentage of participants|||Number
700929|NCT00045435|Secondary|Overall Survival|Percent patients surviving.|By 1 year after transplant|||percentage of participants|||Number
700930|NCT00045435|Primary|Nonrelapse Mortality (NRM)-Incidence of Nonrelapse Death|Defined as death without morphologic evidence of disease. Sufficient evidence will be taken to be an observed rate of NRM within 200 days of transplant that corresponds to a one-sided 80% confidence interval with a lower limit greater than 15%.|200 days after transplant|||percentage of participants|||Number
700931|NCT00045435|Primary|Disease-free Survival-incidence of Survival Without Relapse|Sufficient evidence will be taken to be an observed rate of DFS at one year after transplant that corresponds to a one-sided 95% confidence interval with an upper limit lower than 35%.|By 1 year after transplant|||percentage of participants|||Number
700932|NCT00045487|Primary|Number of Patients With Ani-tumor Activity After Taking OSI-774.|Antitumor activity is measured with conventional techniques such as CT, MRI or X-ray. Scans are done at baseline then evaluated for response every 2 months. All tumor measurements must be recorded millimeters (or decimal fractions of centimeters).|Disease progression or 52 weeks duration|Intent to treat analysis.||participants|||Number
700933|NCT00045630|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 2.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|Patients were assessed for adverse events at weeks 1, 2, 4, 5, 7, 8, and following surgery|Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.||Participants|||Number
700934|NCT00045630|Secondary|Overall Survival (OS)|Overall survival is defined from the date of registration to date of death from any cause|0-2 years|All eligible patients who started treatment were included in the analysis||percentage of participants||95% Confidence Interval|Number
700935|NCT00045630|Primary|Pathologic Complete Response Rate by Transurethral Resection of Bladder Tumor (TURBT) and Imaging Studies After Chemotherapy|Pathologic complete response (CR) is defined as absence of viable tumor in the TURBT specimen. Stable/No Response is defined as at least some disease evaluation tests were done (same tests as baseline) and status does not qualify for CR or Progression. Progression is defined as one or more of the following must occur: unequivocal progression of disease in the opinion of the treating physician. Appearance of any new lesion/site. Death due to disease without documented progression or symptomatic deterioration.|up to 12 weeks after registration (assessed within 8 weeks after completion of 3 cycles of chemotherapy )|All eligible patients who started treatment were included in the analysis||percentage of participants||95% Confidence Interval|Number
701576|NCT00054717|Secondary|Virologic Response (VL < 400 Copies/ml) at Week 96|Percentage of participants with Viral Load < 400 copies/mL|week 96|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
700945|NCT00045734|Other Pre-specified|Determine Correlating Molecular Abnormalities in the Tumor With Response to Treatment|"Measurable: Bidimensionally measurable lesions w/ clearly defined margins by MRI Evaluable: Unidimensionally measurable lesions, masses w/margins not clearly defined.
Complete Response (CR): Complete disappearance of all measurable/evaluable disease. No new lesions. No evidence of non-evaluable disease. Patients on minimal/no steroids.
Partial Response (PR): >/= to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. Responders must be on same/decreasing doses of dexamethasone.
Stable/No Response: Does not qualify for CR, PR, or progression. Progression: 25% increase in the sum of products of all measurable lesions over smallest sum observed (over Baseline (BL) if no decrease), OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer)."|3 years|Study terminated early, only 22 patients entered on study. Hence, this secondary outcome was never analyzed due to number of patients.|||||
700946|NCT00045734|Other Pre-specified|Evidence of Platelet-derived Growth Factor (PDGF) Inhibition in Tumor Specimens|insufficient samples to allow Platelet-derived growth factor receptor (PDGFR-alpha and -beta expression to be correlated Of 22 patients only 7 samples available and only 5 yielded adequate tissue|- 3 years|insufficient samples to allow PDGFR-alpha and -beta expression to be correlated Of 22 patients only 7 samples available and only 5 yielded adequate tissue|||||
700947|NCT00045734|Other Pre-specified|Determine Surrogate Markers of Angiogenic Peptides Using Functional Neuro-imaging and in Vitro Bioassays|Study terminated early, only 22 patients entered on study. Hence, this secondary outcome was never analyzed due number of patients.|5 years|Study terminated early, only 22 patients entered on study. Hence, this secondary outcome was never analyzed due to number of patients.|||||
700948|NCT00045734|Secondary|Determine Survival for Patients Treated With Imatinib Mesylate|survival determined from start of treatment to date of death|3 years|death date of 7 patients were unknown at time of analysis||months||Full Range|Median
700949|NCT00045734|Secondary|Concentration (Steady State) of Imatinib During Cycle One (Pharmacokinetics)|"Blood collected before and at 1,2,4 ad 24 hours after ingestion of imatinib on day 8 of cycle 1
result is the measurement of the before dosing on day 8 (trough level) and the 24 hour dosing day 8"|pre dosing on day 8 and 24 hour dosing day 8 of Pre-dosing Day 9|Only 14 samples available / evaluable for analysis||ng/ml||Standard Deviation|Mean
700960|NCT00045942|Secondary|Summary of CGP52421 Plasma Concentration for 50 mg Bid Arm (E1)|Blood samples were collected for analysis.|Cycle 1: days 1 (0h, 4h, 24 h), 3 (0h), 8 (0h); cycle 2: days 1 (0h); cycle 3: day 1 (0h); cycle 4: day 1 (0h)|The PK population of the mutated PKC412 100 mg/day and wild type PKC412 100 mg/day arms combined, which consisted of all participants who provided at least one evaluable PK sample and received at least one dose of study treatment, was considered for the analysis. For each time point, only participants with non-missing values were analyzed..||ng/ml||Standard Deviation|Mean
701531|NCT00054132|Other Pre-specified|Percentage of Cells Staining Positive for VEGF|Associations between markers and tumor response will be assessed by logistic regression analysis. For those markers that are statistically significant, a cut-point analysis will be performed by the maximum chi-square with p-value adjustment method to determine positive values.|Up to 12 years||||||
700950|NCT00045734|Secondary|Tumor Response as Assessed by MRI Using Macdonald Criteria|"The Macdonald criteria, roughly similarly to other systems, divides response into 4 types of response based on imaging (MRI) and clinical features
1: complete response; 2: partial response; 3:stable disease; 4:progression
Complete response imaging features: disappearance of all enhancing disease (measurable and non-measurable) sustained for at least 4 weeks; no new lesions clinical features; no corticosteroids; clinically stable or improved
Partial response imaging features: 50% or more decrease of all measurable enhancing lesions sustained for at least 4 weeks: no new lesions clinical features: stable or reduced corticosteroids; clinically stable or improved
Stable disease imaging features: does not qualify for complete response, partial response or progression clinical features: clinically stable
Progression imaging features: 25% of more increase in enhancing lesions; any new lesions clinical features: clinical deterioration"|Up to 5 years|response at first scan||participants|||Number
700951|NCT00045734|Secondary|Toxicity as Assessed by the Cancer Therapy Evaluation Program Common Toxicity Criteria (CTC) Version 2.0|percentage of patients who had grade 3 or grade 4 adverse events|Up to 5 years after completion of study treatment|||percentage of patients|||Number
700952|NCT00045734|Secondary|Progression-free Survival According to Response Evaluation Using Macdonald Criteria|"The Macdonald criteria, roughly similarly to other systems, divides response into 4 types of response based on imaging (MRI) and clinical features
1: complete response; 2: partial response; 3:stable disease; 4:progression
Complete response imaging features: disappearance of all enhancing disease (measurable and non-measurable) sustained for at least 4 weeks; no new lesions clinical features; no corticosteroids; clinically stable or improved
Partial response imaging features: 50% or more decrease of all measurable enhancing lesions sustained for at least 4 weeks: no new lesions clinical features: stable or reduced corticosteroids; clinically stable or improved
Stable disease imaging features: does not qualify for complete response, partial response or progression clinical features: clinically stable
Progression imaging features: 25% of more increase in enhancing lesions; any new lesions clinical features: clinical deterioration"|3 years|Of the 22 eligible patients only 19 were evaluable for response||months||Full Range|Median
700953|NCT00045734|Primary|6 Months - Progression-free Survival According to Response Evaluation Using Macdonald Criteria|"The Macdonald criteria, roughly similarly to other systems, divides response into 4 types of response based on imaging (magnetic resonance imaging [MRI]) and clinical features
1: complete response; 2: partial response; 3:stable disease; 4:progression
Complete response imaging features: disappearance of all enhancing disease (measurable and non-measurable) sustained for at least 4 weeks; no new lesions clinical features; no corticosteroids; clinically stable or improved
Partial response imaging features: 50% or more decrease of all measurable enhancing lesions sustained for at least 4 weeks: no new lesions clinical features: stable or reduced corticosteroids; clinically stable or improved
Stable disease imaging features: does not qualify for complete response, partial response or progression clinical features: clinically stable
Progression imaging features: 25% of more increase in enhancing lesions; any new lesions clinical features: clinical deterioration"|At 6 months|Only 19 of the 23 patients were evaluable for response||percentage of participants|||Number
700954|NCT00045942|Secondary|Overall Survival (E2)|OS was measured from the date of the first dose of treatment to the date of death from any cause or the last date the patient was known to be alive (censored observation)|date of FPFV, 21-Aug-2003, to date of LPLV, 27-Mar-2008|The primary efficacy population, which included all participants, who received at least one dose of study drug and who completed at least 8 days of treatment in Cycle 1, unless they discontinued due to progressive disease and/or death due to any cause, and who did not experience any protocol violations, was analyzed..||days||95% Confidence Interval|Median
700955|NCT00045942|Secondary|Time to Disease Progression (E2)|TTP was defined as the time from the first dose date to the date of disease progression, which was defined as the study completion date for unsatisfactory treatment effect, the date of response assessment of progressive disease, or the date of death from any cause|date of FPFV, 21-Aug-2003, to date of LPLV, 27-Mar-2008|The primary efficacy population, which included all participants, who received at least one dose of study drug and who completed at least 8 days of treatment in Cycle 1, unless they discontinued due to progressive disease and/or death due to any cause, and who did not experience any protocol violations, was analyzed..||days||95% Confidence Interval|Median
700956|NCT00045942|Secondary|Best Clinical Response (E2)|Best clinical response was defined as CR, PR, MR, MR+BR, or BR . CR and PR was defined according to NCI definitions, and MR and BR was defined according to the guidelines for defining hematologic improvement in MDS.|date of FPFV, 21-Aug-2003, to date of LPLV, 27-Mar-2008|The primary efficacy population, which included all participants, who received at least one dose of study drug and who completed at least 8 days of treatment in Cycle 1, unless they discontinued due to progressive disease and/or death due to any cause, and who did not experience any protocol violations, was analyzed..||Participants|||Number
700957|NCT00045942|Secondary|Summary of CGP52421 Plasma Concentration for 100 mg Bid Arm (E1)|Blood samples were collected for analysis.|Cycle 1: days 1 (0h, 4h, 24 h), 3 (0h), 8 (0h); cycle 2: days 1 (0h); cycle 3: day 1 (0h); cycle 4: day 1 (0h); cycle 5: day 1 (0h) and cycle 6: day 1 (0h)|The PK population of the mutated PKC412 200 mg/day and wild type PKC412 200 mg/day arms combined, which consisted of all participants who provided at least one evaluable PK sample and received at least one dose of study treatment, was considered for the analysis. For each time point, only participants with non-missing values were analyzed..||ng/ml||Standard Deviation|Mean
700958|NCT00045942|Secondary|Summary of CGP62221 Plasma Concentration for 100 mg Bid Arm (E1)|Blood samples were collected for analysis.|Cycle 1: days 1 (0h, 4h, 24 h), 3 (0h), 8 (0h); cycle 2: days 1 (0h); cycle 3: day 1 (0h); cycle 4: day 1 (0h); cycle 5: day 1 (0h) and cycle 6: day 1 (0h)|The PK population of the mutated PKC412 200 mg/day and wild type PKC412 200 mg/day arms combined, which consisted of all participants who provided at least one evaluable PK sample and received at least one dose of study treatment, was considered for the analysis. For each time point, only participants with non-missing values were analyzed..||ng/ml||Standard Deviation|Mean
700959|NCT00045942|Secondary|Summary of PKC412 Plasma Concentration for 100 mg Bid Arm (E1)|Blood samples were collected for analysis.|Cycle 1: days 1 (0h, 4h, 24 h), 3 (0h), 8 (0h); cycle 2: days 1 (0h); cycle 3: day 1 (0h); cycle 4: day 1 (0h); cycle 5: day 1 (0h) and cycle 6: day 1 (0h)|The PK population of the mutated PKC412 200 mg/day and wild type PKC412 200 mg/day arms combined, which consisted of all participants who provided at least one evaluable PK sample and received at least one dose of study treatment, was considered for the analysis. For each time point, only participants with non-missing values were analyzed..||ng/ml||Standard Deviation|Mean
700961|NCT00045942|Secondary|Summary of CGP62221 Plasma Concentration for 50 mg Bid Arm (E1)|Blood samples were collected for analysis.|Cycle 1: days 1 (0h, 4h, 24 h), 3 (0h), 8 (0h); cycle 2: days 1 (0h); cycle 3: day 1 (0h); cycle 4: day 1 (0h)|The PK population of the mutated PKC412 100 mg/day and wild type PKC412 100 mg/day arms combined, which consisted of all participants who provided at least one evaluable PK sample and received at least one dose of study treatment, was considered for the analysis. For each time point, only participants with non-missing values were analyzed..||ng/ml||Standard Deviation|Mean
700962|NCT00045942|Secondary|Summary of PKC412 Plasma Concentration for 50 mg Twice Daily (Bid) Arm (E1)|Blood samples were collected for analysis.|Cycle 1: days 1 (0h, 4h, 24 h), 3 (0h), 8 (0h); cycle 2: days 1 (0h); cycle 3: day 1 (0h); cycle 4: day 1 (0h)|The PK population of the mutated PKC412 100 mg/day and wild type PKC412 100 mg/day arms combined, which consisted of all participants who provided at least one evaluable PK sample and received at least one dose of study treatment, was considered for the analysis. For each time point, only participants with non-missing values were analyzed..||ng/ml||Standard Deviation|Mean
700963|NCT00045942|Secondary|Event-free Survival (E1)|Event-free survival was defined as the time from date of start of treatment to the date of death from any cause, treatment failure or relapse|from date of FPFV, 27-Mar-2003, to date of LPLV, 06-Sep-2004|Primary efficacy population: defined as all patients who received at least 1 dose of study medication, completed at least eight days of therapy within Cycle 1 unless discontinued due to progressive disease and/or death due to any cause, and who were not considered to be associated with a protocol violation that was exclusionary from the population.||days||95% Confidence Interval|Median
700964|NCT00045942|Secondary|Duration of Best Clinical Response (E1)|Duration of best clinical response was measured from the time that the measurement criteria were met for CR, PR, MR (with or without blast reduction) or BR until the first date that recurrent disease was documented (event) or until the date of last follow up.|from date of FPFV, 27-Mar-2003, to date of LPLV, 06-Sep-2004|Responders from the PEP; PEP defined as all patients who received at least 1 dose of study medication, completed at least 8 days of therapy within Cycle 1 unless discontinued due to progressive disease and/or death due to any cause, and who were not considered to be associated with a protocol violation that was exclusionary from the population.||days||95% Confidence Interval|Median
700965|NCT00045942|Secondary|Overall Survival (OS) (E1)|OS was measured from the date of the first dose of treatment to the date of death from any cause or to the last date that the patient was known to be alive (a censored observation).|from date of FPFV, 27-Mar-2003, to date of LPLV, 06-Sep-2004|Primary efficacy population: defined as all patients who received at least 1 dose of study medication, completed at least eight days of therapy within Cycle 1 unless discontinued due to progressive disease and/or death due to any cause, and who were not considered to be associated with a protocol violation that was exclusionary from the population.||days||95% Confidence Interval|Median
700966|NCT00045942|Secondary|Time to Disease Progression (E1)|TTP was defined as the time from the first dose date to the date of disease progression (defined as the study completion date for unsatisfactory treatment effect, date of response assessment of progressive disease, or date of death from any cause). One participant from the wild type 200 mg group did not have any assessment on treatment and therefore was not taken into account for TTP.|from date of FPFV, 27-Mar-2003, to date of LPLV, 06-Sep-2004|Primary efficacy population: defined as all patients who received at least 1 dose of study medication, completed at least eight days of therapy within Cycle 1 unless discontinued due to progressive disease and/or death due to any cause, and who were not considered to be associated with a protocol violation that was exclusionary from the population.||days||95% Confidence Interval|Median
700967|NCT00045942|Secondary|Summary of CGP52421 Plasma Concentration (Core)|Blood samples were collected for analysis.|Cycle 1: days 1 (24 hour), 3, 8; Cycle 2: day 1,|The Core PK analysis set, which consisted of 15 participants, were considered for the analysis. For each time point, only participants of the PK set who had non-missing values were analyzed.||ng/ml||Standard Deviation|Mean
700968|NCT00045942|Secondary|Summary of CGP62221 Plasma Concentration (Core)|Blood samples were collected for analysis.|Cycle 1: days 1 (24 hour), 3, 8; Cycle 2: day 1,|The Core PK analysis set, which consisted of 15 participants, were considered for the analysis. For each time point, only participants of the PK set who had non-missing values were analyzed.||ng/ml||Standard Deviation|Mean
700969|NCT00045942|Secondary|Summary of Midostaurin Plasma Concentration (Core)|Blood samples were collected for analysis.|Cycle 1: days 1 (24 hour), 3, 8; Cycle 2: day 1,|The Core PK analysis set, which consisted of 15 participants, was considered for the analysis. For each time point, only participants of the PK set who had non-missing values were analyzed.||ng/ml||Standard Deviation|Mean
700970|NCT00045942|Secondary|Time to Disease Progression (TTP) (Core)|TTP was defined as the time from first dose date to date of disease progression which is identified as study completion date for unsatisfactory treatment effect or date of death from any cause within the 28 day cutoff post treatment.|from date of FPFV, 29-Jan-2002, to date of LPLV, 04-Sep-2003|Core primary efficacy population: The core primary efficacy population included all participants who were randomized.||days||95% Confidence Interval|Median
700971|NCT00045942|Primary|Summary of CGP52421 Concentration (E2)|Blood samples were collected for analysis.|Cycle 1: days 1, 2 (24 hr post day 1), 3, 8, 15, 16 (24 hr post day 15), 17, 22; Cycle 2: days 1, 2 (24 hr post day 1), 3, 8, 15|The PK analysis set of the FLT3 mutated PKC412 dose escalation and FLT3 wild type PKC412 dose escalation combined arms, which consisted of the 14 newly enrolled participants, was considered for the analysis. For each time point, participants of the PK analysis set with non-missing values were analyzed.||ng/ml||Full Range|Median
700972|NCT00045942|Primary|Summary of CGP62221 Concentration (E2)|Blood samples were collected for analysis.|Cycle 1: days 1, 2 (24 hr post day 1), 3, 8, 15, 16 (24 hr post day 15), 17, 22; Cycle 2: days 1, 2 (24 hr post day 1), 3, 8, 15|The PK analysis set of the FLT3 mutated PKC412 dose escalation and FLT3 wild type PKC412 dose escalation combined arms, which consisted of the 14 newly enrolled participants, was considered for the analysis. For each time point, participants of the PK analysis set with non-missing values were analyzed.||ng/ml||Full Range|Median
700973|NCT00045942|Primary|Summary of Midostaurin Concentration in the PKC412 Dose Escalation Arms(E2)|Blood samples were collected for analysis.|Cycle 1: days 1, 2 (24 hr post day 1), 3, 8, 15, 16 (24 hr post day 15), 17, 22; Cycle 2: days 1, 2 (24 hr post day 1), 3, 8, 15|The PK analysis set of the FLT3 mutated PKC412 dose escalation and FLT3 wild type PKC412 dose escalation combined arms, which consisted of the 14 newly enrolled participants, was considered for the analysis. For each time point, participants of the PK analysis set with non-missing values were analyzed.||ng/ml||Full Range|Median
700974|NCT00045942|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) for CGP52421 in the PKC412 + Itraconazole Combination Arm (E2)|Blood samples were collected for PK analysis.|Cycle 1: days 21, 22, 28|The pharmacokinetic (PK) population in the midostaurin + itraconazole FLT3 mutated and FLT3 wild-type combined arms, which consisted of 10 participants, was considered for the analysis. For each time point, participants of the PK analysis set with non-missing values were analyzed.||h*ng/ml||Standard Deviation|Mean
700975|NCT00045942|Primary|Time to Reach the Maximum Concentration After Drug Administration (Tmax) for CGP52421 in the PKC412 + Itraconazole Combination Arm (E2)|Blood samples were collected for PK analysis.|Cycle 1: days 21, 22, 28|The pharmacokinetic (PK) population in the midostaurin + itraconazole FLT3 mutated and FLT3 wild-type combined arms, which consisted of 10 participants, was considered for the analysis. For each time point, participants of the PK analysis set with non-missing values were analyzed.||hour||Full Range|Median
700976|NCT00045942|Primary|Observed Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax) for CGP52421 in the PKC + Itraconazole Combination Arm (E2)|Blood samples were collected for pharmacokinetic (PK) analysis.|Cycle 1: days 21, 22, 28|The pharmacokinetic (PK) population in the midostaurin + itraconazole FLT3 mutated and FLT3 wild-type combined arms, which consisted of 10 participants, was considered for the analysis. For each time point, participants of the PK analysis set with non-missing values were analyzed.||ng/ml||Standard Deviation|Mean
700977|NCT00045942|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau) for CGP52421 Plasma in the PKC + Itraconazole Combination Arm (E2)|Blood samples were collected for pharmacokinetic (PK) analysis.|Cycle 1: days 21, 22, 28|The pharmacokinetic (PK) population in the midostaurin + itraconazole FLT3 mutated and FLT3 wild-type combined arms, which consisted of 10 participants, was considered for the analysis. For each time point, participants of the PK analysis set with non-missing values were analyzed.||h*ng/ml||Standard Deviation|Mean
700978|NCT00045942|Primary|Terminal Elimination Half-life (T1/2) for CGP62221 in the PKC + Itrconazole Combination Arm (E2)|Blood samples were collected for PK analysis.|Cycle 1: day 22,|The pharmacokinetic (PK) population in the midostaurin + itraconazole FLT3 mutated and FLT3 wild-type combined arms, which consisted of 10 participants, was considered for the analysis. For this end point, 4 participants with non-missing values were analyzed.||hour||Standard Deviation|Mean
700979|NCT00045942|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) for CGP622221 in the PKC412 + Itraconazole Combination Arm (E2)|Blood samples were collected for PK analysis.|Cycle 1: days 21, 22, 28|The pharmacokinetic (PK) population in the midostaurin + itraconazole FLT3 mutated and FLT3 wild-type combined arms, which consisted of 10 participants, was considered for the analysis. For each time point, participants of the PK analysis set with non-missing values were analyzed.||h*ng/ml||Standard Deviation|Mean
700980|NCT00045942|Primary|Time to Reach the Maximum Concentration After Drug Administration (Tmax) for CGP62221 in the PKC412 + Itraconazole Combination Arm (E2)|Blood samples were collected for PK analysis.|Cycle 1: days 21, 22, 28|The pharmacokinetic (PK) population in the midostaurin + itraconazole FLT3 mutated and FLT3 wild-type combined arms, which consisted of 10 participants, was considered for the analysis. For each time point, participants of the PK analysis set with non-missing values were analyzed.||hour||Full Range|Median
700981|NCT00045942|Primary|Observed Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax) for CGP62221 in the PKC + Itraconazole Combination Arm (E2)|Blood samples were collected for pharmacokinetic (PK) analysis.|Cycle 1: days 21, 22, 28|The pharmacokinetic (PK) population in the midostaurin + itraconazole FLT3 mutated and FLT3 wild-type combined arms, which consisted of 10 participants, was considered for the analysis. For each time point, participants of the PK analysis set with non-missing values were analyzed.||ng/ml||Standard Deviation|Mean
700982|NCT00045942|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau) for CGP62221 Plasma in the PKC + Itraconazole Combination Arm (E2)|Blood samples were collected for pharmacokinetic (PK) analysis.|Cycle 1: days 21, 22, 28|The pharmacokinetic (PK) population in the midostaurin + itraconazole FLT3 mutated and FLT3 wild-type combined arms, which consisted of 10 participants, was considered for the analysis. For each time point, participants of the PK analysis set with non-missing values were analyzed.||h*ng/ml||Standard Deviation|Mean
700983|NCT00045942|Primary|Terminal Elimination Half-life (T1/2) for PKC412 in the PKC + Itrconazole Combination Arm (E2)|Blood samples were collected for PK analysis.|Cycle 1: days 21 and 22|The pharmacokinetic (PK) population in the midostaurin + itraconazole FLT3 mutated and FLT3 wild-type combined arms, which consisted of 10 participants, was considered for the analysis. For each time point, participants of the PK analysis set with non-missing values were analyzed.||hour||Standard Deviation|Mean
700984|NCT00045942|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) for PKC412 in the PKC412 + Itraconazole Combination Arm (E2)|Blood samples were collected for PK analysis.|Cycle 1: days 21, 22, 28|The pharmacokinetic (PK) population in the midostaurin + itraconazole FLT3 mutated and FLT3 wild-type combined arms, which consisted of 10 participants, was considered for the analysis. For each time point, participants of the PK analysis set with non-missing values were analyzed.||h*ng/ml||Standard Deviation|Mean
700985|NCT00045942|Primary|Time to Reach the Maximum Concentration After Drug Administration (Tmax) for PKC412 in the PKC412 + Itraconazole Combination Arm (E2)|Blood samples were collected for PK analysis.|Cycle 1: days 21, 22, 28|The pharmacokinetic (PK) population in the midostaurin + itraconazole FLT3 mutated and FLT3 wild-type combined arms, which consisted of 10 participants, was considered for the analysis. For each time point, participants of the PK analysis set with non-missing values were analyzed.||hour||Full Range|Median
700986|NCT00045942|Primary|Observed Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax) for PKC412 in the PKC + Itraconazole Combination Arm (E2)|Blood samples were collected for pharmacokinetic (PK) analysis.|Cycle 1: days 21, 22, 28|The pharmacokinetic (PK) population in the midostaurin + itraconazole FLT3 mutated and FLT3 wild-type combined arms, which consisted of 10 participants, was considered for the analysis. For each time point, participants of the PK analysis set with non-missing values were analyzed.||ng/ml||Standard Deviation|Mean
701577|NCT00054717|Secondary|Virologic Response (VL < 400 Copies/ml) at Week 88|Percentage of participants with Viral Load < 400 copies/mL|week 88|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
700987|NCT00045942|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau) for PKC412 Plasma in the PKC + Itraconazole Combination Arm (E2)|Blood samples were collected for pharmacokinetic (PK) analysis.|Cycle 1: days 21, 22, 28|The pharmacokinetic (PK) population in the midostaurin + itraconazole FLT3 mutated and FLT3 wild-type combined arms, which consisted of 10 participants, was considered for the analysis. For each time point, participants of the PK analysis set with non-missing values were analyzed.||h*ng/ml||Standard Deviation|Mean
700988|NCT00045942|Primary|Percent Decrease in Phospho-FLT3 Compared to Baseline (E2)||Days 1, 28|The analyses for this outcome measure were not performed due to technical challenges in measuring phosphorylated FLT3 in patient blast samples in an ex vivo setting.|||||
700989|NCT00045942|Primary|Percent Decrease in Phospho-FLT3 Compared to Baseline (E1)||days 1, 28|The analyses for this outcome measure were not performed due to technical challenges in measuring phosphorylated FLT3 in patient blast samples in an ex vivo setting.|||||
700990|NCT00045942|Primary|Number of Participants With Overall Clinical Response (E1)|Overall clinical response was defined as CR, PR, minor response (MR) or blast response (BR). CR and PR was defined according to NCI definitions, and MR and BR was defined according to the guidelines for defining hematologic improvement in MDS.|from date of FPFV, 27-Mar-2003, to date of LPLV, 06-Sep-2004|E1 primary efficacy population: all participants who received at least one dose of study medication, completed at least 8 days of therapy within Cycle 1 unless discontinued due to progressive disease and/or death due to any cause, and who were not considered to be associated with a protocol violation that was exclusionary from the population.||Participants|||Number
700991|NCT00045942|Primary|Percent Decrease in Phospho-FLT3 Compared to Baseline (Core)||days 1, 28|This outcome measure was not analyzed. Assessment of FLT3 autophosphorylation in leukemic blasts was not possible at the planned time points because the blast reduction was rapid and occurred during the first week in some participants. Thus, by Day 28, the blast count in some participants were too low for autophosphorylation to be measured.|||||
700992|NCT00045942|Primary|Number of Participants With Best Clinical Response (Core)|Best clinical response was defined as complete response (CR) or partial response (PR), according to NCI definitions for AML and the guidelines for defining responses in MDS.|from date of first patient first visit (FPFV), 29-Jan-2002, to date of last participant last visit (LPLV), 04-Sep-2003|Core primary efficacy population: The core primary efficacy population included all participants who were randomized.||Participants|||Number
700993|NCT00046228|Other Pre-specified|Subjects With Pre-Specified Complications of Index Myocardial Infarction Through Discharge/Day 7|Number of subjects with one or more of the following: 2nd or 3rd Degree AVB, Asystole, Sustained V Tach, A Fib/Flutter, EMD/Pulseless Electrical Activity, Heart Failure, Tamponade, Myocardial Rupture, Papillary Muscle Rupture, Ventricular Septal Defect, Pulmonary Embolism, Systemic Arterial Embolism and/or Pericarditis/Pericardial Effusion.|Discharge/Day 7|Population is the intent-to-treat subjects. The intent-to-treat population is defined as all randomized subjects classified according to the randomization assignment.||participants|||Number
700994|NCT00046228|Other Pre-specified|Subjects With Any Investigator Reported Bleeding Events Through Discharge/Day 7||Discharge/Day 7|The population was defined as all subjects who were randomized and treated with any study agent, including those who discontinued for any reasons. Subjects randomized and treated was classified according to the study drug(s) received.||participants|||Number
700995|NCT00046228|Other Pre-specified|Subjects With Severe Thrombocytopenia Through Discharge/Day 7|Severe thrombocytopenia is defined as platelet count < 50,000 cells/μL.|Discharge/Day 7|The population was defined as all subjects who were randomized and treated with any study agent, including those who discontinued for any reasons. Subjects randomized and treated was classified according to the study drug(s) received.||participants|||Number
700996|NCT00046228|Other Pre-specified|Subjects With Non Intracranial Thrombolysis In Myocardial Infarction (TIMI) Bleeding Events Through Discharge/Day 7|Subjects with nonintracranial TIMI bleeding (either major or minor) through discharge/day 7, originating from vascular instrumentation sites, non-instrument related bleeding, as well as overall, were examined.|Discharge/Day 7|The population was defined as all subjects who were randomized and treated with any study agent, including those who discontinued for any reasons. Subjects randomized and treated was classified according to the study drug(s) received.||participant|||Number
700997|NCT00046228|Other Pre-specified|Subjects With Intracranial Hemorrhage (Including Hemorrhagic Transformation) Through Discharge/Day 7|All cases of cerebrovascular event were confirmed by a CEC (Clinical Endpoints Committee).|Discharge/Day 7|The population was defined as all subjects who were randomized and treated with any study agent, including those who discontinued for any reasons. Subjects randomized and treated was classified according to the study drug(s) received.||participants|||Number
700998|NCT00046228|Secondary|All-Cause Mortality Through 1 Year|All-cause mortality through 1 year from randomization.|1 year|Population is the intent-to-treat subjects. The intent-to-treat population is defined as all randomized subjects classified according to the randomization assignment.||participants|||Number
700999|NCT00046228|Secondary|Subjects With ST-Segment Resolution > 70% From Baseline at 60 to 90 Minutes Following Randomization||60 to 90 minutes|Population is the intent-to-treat subjects who were selected for evaluation by electrocardiogram (ECG) core laboratory.Subjects, who were not evaluable for a 60-90 minute ECG, were considered not having a ST segment resolution.||participants|||Number
701000|NCT00046228|Secondary|All-Cause Mortality Through 90 Days|All cause mortality occurred through 90 days from randomization.|90 days|Population is the intent-to-treat subjects. The intent-to-treat population is defined as all randomized subjects classified according to the randomization assignment.||participants|||Number
701001|NCT00046228|Secondary|Complications of MI as Defined in the Primary Outcome Measure Through 90 Days|The complications of myocardial infarction (MI) is defined as any event of rehospitalization or emergency department visit for CHF, cardiogenic shock, or resuscitated ventricular fibrillation occurring > 48 hours after randomization.|90 Days|Population is the intent-to-treat subjects. The intent-to-treat population is defined as all subjects that have been randomly assigned to a treatment group and classified according to the randomization assignment.||participants|||Number
701532|NCT00054132|Other Pre-specified|Percentage of Cells Staining Positive for Tumor Protein p53 (p53)|Associations between markers and tumor response will be assessed by logistic regression analysis. For those markers that are statistically significant, a cut-point analysis will be performed by the maximum chi-square with p-value adjustment method to determine positive values.|Up to 12 years||||||
701002|NCT00046228|Primary|The Composite of All-Cause Mortality or Complications of MI at 90 Days.|Occurs within 90 days and is composite of all-cause mortality or complications of myocardial infarction (MI) (rehospitalization or emergency department visit for congestive heart failure (CHF), cardiogenic shock, or resuscitated ventricular fibrillation occurring > 48 hours after randomization).|90 days|Population is the intent-to-treat subjects. The intent-to-treat population is defined as all subjects randomly assigned to a treatment group and classified according to the randomization assignment.||participants|||Number
701003|NCT00046475|Primary|Post-treatment OHSA Item 1 Score of US Participants With Marked/Severe Disease According to The CGI-S Scale|Item 1 of the OHSA asked the patient to rate, using a 0-10 scale (0 meaning not bothered and 10 meaning the worst), his or her impression of the severity of dizziness, lightheadedness, feeling faint, or feeling like you might black out whenever he or she was standing and that improved when he or she sat or laid down. The results are reported by degree of severity according to the CGI-S scale, which uses 4 categories to describe disease severity: Mild, Moderate, Marked, and Severe. The Item 1 scores reported are grouped for participants with Marked or Severe disease severity. Higher scores indicate more severe disease.|End of 2-week treatment period|Randomized participants enrolled at any of the 28 US sites||scores on a scale||Standard Deviation|Mean
701004|NCT00046475|Primary|Post-treatment OHSA Item 1 Score of United States (US) Participants With Mild/Moderate Disease According to The Clinical Global Impressions-Severity (CGI-S) Scale|Item 1 of the OHSA asked the patient to rate, using a 0-10 scale (0 meaning not bothered and 10 meaning the worst), his or her impression of the severity of dizziness, lightheadedness, feeling faint, or feeling like you might black out whenever he or she was standing and that improved when he or she sat or laid down. The results are reported by degree of severity according to the CGI-S scale, which uses 4 categories to describe disease severity: Mild, Moderate, Marked, and Severe. The Item 1 scores reported are grouped for participants with Mild or Moderate disease severity. Higher scores indicate more severe disease.|End of 2-week treatment period|Randomized participants enrolled at any of the 28 US sites||scores on a scale||Standard Deviation|Mean
701005|NCT00046475|Secondary|Convergent Validity of the Intent-to-Treat (ITT) Population|Item 1 of the OHSA and the OHSA composite score were analyzed for convergent validity with the CGI-I-Clinician scores. The change from baseline in the CGI-I scores are correlated with the OHSA Item 1 score change from baseline and the OHSA composite score change from baseline for the subjects in the ITT population. Values shown are Spearman correlation coefficients.|From the time of titration until the end of treatment|Intent-to-Treat, defined as all patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.||correlation coefficient|||Number
701006|NCT00046475|Secondary|Responsiveness of the Intent-to-Treat (ITT) Population|Item 1 of the OHSA, the OHSA composite score, and the OHDAS global daily activity score were analyzed for responsiveness as a measure of validity. Assuming that subjects who received Placebo during Randomization Period 1 are stable between Visit 3A and Visit 5, and using them as the stable subjects, responsiveness was calculated as [(OH CFB in Midodrine group)-(OH CFB in Placebo group)]/(SD of OH CFB in Placebo group), where CFB is change from baseline, SD is the standard deviation of OH CFB of the stable subjects; the value reported is the quotient of this equation.|From the time of titration until the end of treatment|Intent-to-Treat, defined as all patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.||quotient|||Number
701007|NCT00046475|Secondary|Test Reliability of the Intent-to-Treat (ITT) Population|Item 1 of the OHSA, the OHSA composite score, and the OHDAS global daily activity score were analyzed for test-retest reliability as a measure of validity. Test-retest reliability is the Pearson product-moment correlation coefficient calculated between OHQ scores at Visit 3A (baseline measure) and OHQ scores at Visit 5 for the subjects who received Placebo during Randomization Period 1.|From the time of titration until the end of treatment|Intent-to-Treat, defined as all patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.||correlation coefficient|||Number
701008|NCT00046475|Secondary|Change From Baseline in Short Form-36 (SF-36) Version 2 Health Survey Questionnaire Scores|"The SF-36 consists of 36 items in eight domains: physical functioning, general health, role-physical, bodily pain, vitality, social functioning, role-emotional, and mental health. Version 2 references one week ago for some questions. Raw scale scores for the SF-36 were transformed to a 0-100 scale with a higher score indicating a better quality of life. A positive change from baseline indicates that symptoms have improved. The SF-36 was completed at Visit 5 (Period 2) and Visit 6 (study completion) and compared to the score from Visit 3A (titration)."|From the time of titration until the end of treatment|Intent-to-Treat, defined as all patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.||scores on a scale||Standard Deviation|Mean
701009|NCT00046475|Secondary|Change From Baseline in Supine BP|Supine BP was measured at Visit 5 (Period 2) and Visit 6 (study completion) and compared to measurements taken at Visit 3A (titration). Supine BP was measured after the patient had been in the supine position for 5 minutes.|From the time of titration until the end of treatment|Intent-to-Treat, defined as all patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.||mmHg||Standard Deviation|Mean
701010|NCT00046475|Secondary|Change From Baseline in Standing Blood Pressure (BP)|Standing BP was measured at Visit 5 (Period 2) and Visit 6 (study completion) and compared to measurements taken at Visit 3A (titration). Standing BP was measured 3 minutes after the patient rose from the supine position or as soon as the patient indicated they needed to sit down. If the patient indicated he or she needed to sit down, the BP measurement was taken while in the standing position, before the patient sat down.|From the time of titration until the end of treatment|Intent-to-Treat, defined as all patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.||mmHg||Standard Deviation|Mean
701021|NCT00046566|Primary|Change From Baseline in Average Systolic Blood Pressure at 8 Weeks|The change of systolic blood pressure was calculated as the mean of 6 blood pressure values from two 8-week visits minus the mean of 6 values from two baseline visits within each intervention phase. At each visit, 3 BP values were measured with a Hawksley random-zero sphygmomanometer by trained and certified observers who were masked to group assignment. BP readings were taken from the right arm with appropriately sized cuffs after the participant had been seated quietly for 5 minutes. The participant was instructed not to eat, smoke, drink alcohol, or exercise for at least 30 minutes before their BP measurements.|Every 8 weeks|participants took soy protein during three phases||mmHg||95% Confidence Interval|Mean
701011|NCT00046475|Secondary|Percent of Participants Scored as Improved on The Patient Version of The CGI-I Scale|"The CGI-I is a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Clinical Global Impressions ratings are completed with respect to neurogenic OH symptoms. A value of 0 was used if the investigator or patient assessment was not performed. The improved category is made up of patients who were evaluated as very much improved, much improved, or slightly improved for the classification of Overall Improvement. The CGI-I was completed at Visit 5 (Period 2) and Visit 6 (study completion)."|From the time of titration until the end of treatment|Intent-to-Treat, defined as all patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.||percent of participants|||Number
701012|NCT00046475|Secondary|Percent of Participants Scored as Improved on The Clinician Version of The Clinical Global Impressions Improvement (CGI-I) Scale|"The CGI-I is a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Clinical Global Impressions ratings are completed with respect to neurogenic OH symptoms. A value of 0 was used if the investigator or patient assessment was not performed. The improved category is made up of patients who were evaluated as very much improved, much improved, or slightly improved for the classification of Overall Improvement. The CGI-I was completed at Visit 5 (Period 2) and Visit 6 (study completion)."|From the time of titration until the end of treatment|Intent-to-Treat, defined as all patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.||percent of participants|||Number
701013|NCT00046475|Secondary|Change From Baseline in The Orthostatic Hypotension Global Daily Activity Score|The OHDAS global daily activity score was calculated as the average of all daily activity item scores. The OHDAS had 4 items that asked the patient to give a graduated score from 0 (no limitation due to OH) to 10 (complete limitation due to OH) to activities that required standing for a short time, standing for a long time, walking for a short time, walking for a long time. Symptomatology was assessed at Visit 3A (titration), Visit 5 (Period 2), and Visit 6 (study completion). A negative change from baseline indicates that symptoms have improved.|From the time of titration until the end of treatment|Intent-to-Treat, defined as all patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.||scores on a scale||Standard Deviation|Mean
701014|NCT00046475|Secondary|Change From Baseline in The Orthostatic Hypotension Daily Activity Scale (OHDAS) Items 1 Through 4 Scores|The OHDAS had 4 items that asked the patient to give a graduated score from 0 (no limitation due to OH) to 10 (complete limitation due to OH). Item 1 addressed activities that required standing for a short time; Item 2, activities that required standing for a long time; Item 3, activities that required walking for a short time; and Item 4, activities that required walking for a long time. Symptomatology was assessed at Visit 3A (titration), Visit 5 (Period 2), and Visit 6 (study completion). A negative change from baseline indicates that symptoms have improved.|From the time of titration until the end of treatment|Intent-to-Treat, defined as all patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.||scores on a scale||Standard Deviation|Mean
701015|NCT00046475|Secondary|Change From Baseline in The OHSA Composite Symptom Score|The OHSA composite symptom score was calculated by taking the average of the ratings for the symptoms present at Baseline. Participants were asked to rate symptoms by using a 0-10 scale (0 meaning not bothered and 10 meaning the worst). For subsequent visits, only those symptoms present at Baseline were scored. In this manner, a score was produced that represents the severity (and subsequent change in severity) of the patient's neurogenic OH symptoms, regardless of how many symptoms are presented at Baseline. Symptomatology was assessed at Visit 3A (titration), Visit 5 (Period 2), and Visit 6 (study completion). A negative change from baseline indicates that symptoms have improved.|From the time of titration until the end of treatment|Intent-to-Treat, defined as all patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.||scores on a scale||Standard Deviation|Mean
701016|NCT00046475|Secondary|Change From Baseline in The OHSA Items 2 Through 6 Scores|Items 2 through 6 of the OHSA asked the patient to rate, using a 0-10 scale (0 meaning not bothered and 10 meaning the worst), his or her impression of the severity of the following symptoms whenever he or she was standing and that improved when he or she sat down or laid down: Item 2 addresses problems with vision (blurring, seeing spots, tunnel vision, etc); Item 3, weakness; Item 4, fatigue; Item 5, trouble concentrating; and Item 6, head or neck discomfort. Symptomatology was assessed at Visit 3A (titration), Visit 5 (Period 2), and Visit 6 (study completion). A negative change from baseline indicates that symptoms have improved.|From the time of titration until the end of treatment|Intent-to-Treat, defined as all patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.||scores on a scale||Standard Deviation|Mean
701017|NCT00046475|Primary|Re-analysis of The Post-treatment Score For Item 1 of The OHSA Scale, Excluding Two Sites|Item 1 of the OHSA asked the patient to rate, using a 0-10 scale (0 meaning not bothered and 10 meaning the worst), his or her impression of the severity of dizziness, lightheadedness, feeling faint, or feeling like you might black out whenever he or she was standing and that improved when he or she sat or laid down. Higher scores indicate more severe disease.|End of 2-week treatment period|Intent-to-Treat, defined as all patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement. Data for 2 sites were excluded from this re-analysis.||scores on a scale||Standard Deviation|Mean
701018|NCT00046475|Primary|Post-treatment Score For Item 1 of The Orthostatic Hypotension Symptom Assessment (OHSA) Scale|Item 1 of the OHSA asked the patient to rate, using a 0-10 scale (0 meaning not bothered and 10 meaning the worst), his or her impression of the severity of dizziness, lightheadedness, feeling faint, or feeling like you might black out whenever he or she was standing and that improved when he or she sat or laid down. Higher scores indicate more severe disease.|End of 2-week treatment period|Intent-to-Treat, defined as all patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.||scores on a scale||Standard Deviation|Mean
701019|NCT00046566|Secondary|Body Weight at 8 Weeks|Body weight was measured by trained staff using a standard protocol at week 8.|Every 8 weeks|Participants took supplementation for 8 weeks||kg||95% Confidence Interval|Mean
701020|NCT00046566|Secondary|Change From Baseline in Serum LDL-cholesterol at 8 Weeks|Change in serum LDL-cholesterol was calculated as LDL-cholesterol at 8 weeks minus LDL-cholesterol at baseline. Over-night fasting serum LDL-cholesterol was measured with an enzymatic method.|Every 8 weeks|Participants took soy protein for 8 weeks||mg/dL||95% Confidence Interval|Mean
701022|NCT00046839|Primary|Overall Survival|Because only 21 patients (18 analyzable) out of 128 planned were accrued on this study, all analyzable patients were combined to report overall survival. The original study design planned for a comparison to a historical control, but due to the small number of patients, survival time is only reported, not tested.|From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 12 months.|Eligible patients who started protocol treatment.||years||95% Confidence Interval|Median
701023|NCT00046839|Primary|Maximum Tolerated Dose (MTD) of Celecoxib Combined With Radiation Therapy (RT)|"Patients were followed for at least 90 days from start of RT and carefully evaluated with respect to treatment morbidity. A dose limiting toxicity (DLT) was defined as grade 3 or 4 nonhematologic (excluding nausea, vomiting, and alopecia) and grade 4 hematologic toxicities. Six patients were to be accrued at each dose level. If no more than three of the six patients experienced a DLT then that dose level was considered acceptable and dose escalation occurred by accruing six more patients at the next dose level. Otherwise, the preceding dose level, if any, would be declared the MTD. The MTD would be used for the Phase II arm. At a given dose, the probability of halting dose escalation when the true toxicity is 50% or higher is at least 66% (power). In addition, if the true DLT rate is instead 20%, there will still be a 10% probability of halting dose escalation at a given dose level (type I error).
Rating scale: 0 = not the MTD, 1 = MTD"|Start of treatment to 90 days|The first six eligible patients who started protocol treatment at each dose level.||units on a scale|||Number
701024|NCT00046891|Secondary|Associations Between Self-report Measures of Cognition and the Trail Making Test (TMT) A and B.|Pearson correlation coefficients conceptually related objective TMT A and B and subjective self-report measures of cognition. For this analysis data from both arms are combined. In the table below, numbers closer to 1 indicate positive correlation; numbers closer to -1 indicate negative correlation.|Baseline, 1, 6, 12, 18 and 24 months time points|Secondary analyses uses all patients that reported data for baseline and one of the post baseline time points.||Pearson correlation coefficient|||Number
701025|NCT00046891|Secondary|Associations Between Self-reported Cognition and the HSCS.|Pearson correlation coefficients conceptually related objective HSCS and subjective self-reported cognition. For this analysis data from both arms are combined. In the table below, numbers closer to 1 indicate positive correlation; numbers closer to -1 indicate negative correlation.|Baseline, 1, 6, 12, 18 and 24 months time points|Secondary analyses uses all patients that reported data for baseline and one of the post baseline time points.||Pearson correlation coefficient|||Number
701026|NCT00046891|Secondary|Self-reported Symptoms or Side Effects Using Symptom Experience Diary (SED)|Self-reported symptoms or side effects mean change from baseline to 1st post chemo visit (negative numbers indicate worsening symptoms). A descriptive report of the toxicities experienced by participants will be measured with a Symptom Experience Diary. Participants will complete this questionnaire. This patient diary contains several questions related to potential side effects and side benefits of Ginko Biloba measured on a numeric analogue scale (based on 0-10 scale with 10 being worst toxicity).|Baseline, 1st evaluation of post chemotherapy.|Secondary analyses uses all patients that reported data for baseline and post chemo visit.||units on a scale||Standard Deviation|Mean
701027|NCT00046891|Secondary|Secondary Measure of Cognitive Function Using Trail Making Tests (TMT) A and B.|TMT A and B were analyzed by evaluating median changes from baseline to different time points. Lower scores are better. The Trail Making Test will provide additional validity and verification for the assessment of overall cognitive dysfunction. Abbreviations used for category titles in the table below: Baseline (BL), change (chg), month (mth).|Baseline, 1, 6, 12, 18 and 24 months post chemotherapy.|Secondary analysis uses all patients that reported baseline and at least one post baseline time point data.||seconds||Full Range|Median
701028|NCT00046891|Secondary|Median Scores for Trail Making Tests A and B (Lower Scores Are Better).|The Trail Making Test is a measure of overall brain dysfunction. Time taken to complete TMT tests was recorded. For this analysis median values of the Trail Making tests are calculated at different time points.|Baseline, 1, 6, 12, 18 and 24 months time points|Secondary analyses uses all patients that reported data for all the time points.||seconds||Full Range|Median
701029|NCT00046891|Primary|The Level of Cognitive Dysfunction as Measured by the High Sensitivity Cognitive Screen (HSCS) Overall Score.|The primary analysis involved compiling each subscale score for the HSCS into area under the curve (AUC) scores for the data points from baseline to the 12 month data point. HSCS instrument contains questions regarding Memory (0-39), Language (0-30), Visual-motor (0-10), Spatial (0-8), Attention and Concentration (0-25), Self-Regulation and Planning (0-6) on a varying scales. Total is calculated by summing afore mentioned subscales, values of Total ranged from 0 to 125. Lower scores are better.|Baseline, 12 months after starting Chemotherapy.|Efficacy analyses uses all patients that reported baseline and one value after baseline.||units on a scale*months||Standard Deviation|Mean
701030|NCT00053365|Secondary|Duration of Progression-free Survival||From study entry until disease progression, death or date of last contact, assessed up to 5 years||||||
701031|NCT00053365|Secondary|Overall Survival and Progression-free Survival|Per Gynecologic Oncology Group(GOG) Response Evaluation Criteria in Solid Tumors(RECIST) Criteria, progression is defined as at least a 20% increase in the sum of longest dimesions(LD) of target lesions taking as reference the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.|From entry into study to death or date of last contact, assessed up to 5 years|||months||95% Confidence Interval|Median
701032|NCT00053365|Primary|Frequency and Severity of Observed Adverse Events, Graded According to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0||Up to 5 years||||||
701033|NCT00053365|Primary|Tumor Response|"Per Gynecologic Oncology Group(GOG) Response Evaluation Criteria in Solid Tumors(RECIST) Criteria: Complete Response is disappearance of all target and non-target lesions; Partial Response is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable dimensions; Increasing Disease is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.
Response is to be evaluated every 42 days for the first 6 months and every 6 months thereafter while the patient is receiving study treatment, then every 3 months for 2 years and every 6 months for the next 3 years until documented progression or death."|From entry into study until documented progression or death, assessed up to 5 years.|||participants|||Number
701617|NCT00054717|Secondary|Median Change From Baseline in Viral Load to Week 8||Baseline to Week 8|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Log(Copies/mL)||Inter-Quartile Range|Median
701034|NCT00053417|Primary|Median Percent Change From Baseline in Average Walking Speed on Timed 25-Foot Walk Test|The primary efficacy variable was the percent change from baseline in average walking speed measured using the Timed 25-Foot Walk Test during the 12-week stable dose period (the average of Study Days 56, 84, and 112), relative to the mean at baseline (placebo run-in period, the average of Study Days 7 and 14).|Baseline (placebo run-in period); 12-week stable dose period|||percent change||Full Range|Median
701035|NCT00053482|Other Pre-specified|Clinical Chemistry Parameters (Aspartate Transaminase and Alanine Transaminase) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine||Days 0 (Baseline) and 15 post-vaccination|Clinical chemistry parameters were assessed in the intent-to-treat safety population||IU/L||Standard Deviation|Mean
701036|NCT00053482|Other Pre-specified|Clinical Chemistry Parameters (Creatinine and Glucose) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine||Days 0 (Baseline) and 15 post-vaccination|Clinical chemistry parameters were assessed in the intent-to-treat safety population||mg/dL||Standard Deviation|Mean
701037|NCT00053482|Other Pre-specified|Selected Hematology Parameters (Red Bood Cell and Platelets) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine||Days 0 (Baseline) and 15 post-vaccination|The hematology parameters were assessed in the intent-to-treat safety population.||x10^6th/µL||Standard Deviation|Mean
701038|NCT00053482|Other Pre-specified|Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine||Days 0 (Baseline) and 15 post-vaccination|The hematology parameters were assessed in the intent-to-treat safety population.||Percentage (%)||Standard Deviation|Mean
701039|NCT00053482|Other Pre-specified|Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine||Days 0 to 30 post-vaccination|Treatment-emergent rash events were assessed in the safety intent-to-treat population.||Participants|||Number
701040|NCT00053482|Primary|Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine||Days 0 to 30 post-vaccination|Post-vaccination adverse events were assessed in the safety, intent-to-treat population.||Participants|||Number
701041|NCT00053482|Primary|Participants With ≥ 4-fold Increase in Plaque-Reduction Neutralization Test (PRNT50) Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine.||Day 30 post-vaccination|||Participants|||Number
701042|NCT00053482|Primary|The Neutralizing Antibody Response Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine|The neutralizing antibody response titers were determined by the Plaque-Reduction Neutralization Test (PRNT50)|Day 30 post-vaccination|The neutralizing antibody response titers were assessed in the antibody evaluable, per-protocol population.||PRNT50 Titers||Standard Deviation|Mean
701043|NCT00053495|Other Pre-specified|Selected Hematology Parameters (Red Blood Count and Platelets) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine.||Days 0 (baseline) and 15 post-vaccination|Hematology parameters were evaluated in the safety, intent-to-treat population.||x10-6th/μL||Standard Deviation|Mean
701044|NCT00053495|Other Pre-specified|Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine.||Days 0 (baseline) and 15 post-vaccination|Hematology parameters were evaluated in the safety, intent-to-treat population.||Percentage (%)||Standard Deviation|Mean
701045|NCT00053495|Primary|Participants With ≥ 4-fold Increase in Plaque-Reduction Neutralization Test (PRNT50) Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine.||Day 30 post-vaccination|Plaque-reduction neutralization test (PRNT50) titers were determined in the antibody evaluable, per-protocol population||Participants|||Number
701046|NCT00053495|Other Pre-specified|Clinical Chemistry Parameters (Creatinine and Glucose) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine||Days 0 (baseline) and 15 post-vaccination|Clinical chemistry parameters were assessed in safety, intent-to-treat population||mg/dL||Standard Deviation|Mean
701047|NCT00053495|Other Pre-specified|Clinical Chemistry Parameters (Aspartate Aminotransaminase and Alanine Aminotransferase) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine||Days 0 (baseline) and 15 post-vaccination|Clinical chemistry parameters were assessed in safety, intent-to-treat population||IU/L||Standard Deviation|Mean
701048|NCT00053495|Other Pre-specified|Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine.||Days 0 to 30 post-vaccination|Treatment-emergent rash events were assessed in the safety, intent-to-treat population.||Participants|||Number
701049|NCT00053495|Primary|Neutralizing Antibody Response Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine.||Day 30 post-vaccination|Neutralizing antibody response titers were evaluated in the antibody evaluable, per-protocol population.||PRNT50 Titers||Standard Deviation|Mean
701050|NCT00053495|Primary|Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine|The severity of each reported adverse event was classified by the investigator according to the following definitions. None - no symptom; Mild - awareness of sign or symptoms, but easily tolerated; Moderate - discomfort enough to cause interference with usual activity; and Severe - incapacitating with inability to work or perform usual activity.|Days 0 to 30 post-vaccination|Adverse events were assessed in the safety, intent-to-treat population||Participants|||Number
701051|NCT00053677|Primary|Yale-Brown Obsessive Compulsive Scale for Pathological Gambling (PG-YBOCS)|A gambling severity measure derived from the Yale-Brown Obsessive Compulsive Scale. It sums gambling urges and thoughts questions to make a total score. Total scores range from 0 to 40, which higher scores indicating more severe gambling symptoms (worse outcome).Administered every week for the first 8 weeks and every other week for the remaining 10 weeks. Final visit scores were the scores measured at the last visit for each participant; data from previous visits were not combined to compute this value.|18 weeks|||units on a scale||Standard Deviation|Mean
701052|NCT00053703|Secondary|Change From Baseline in Body Mass Index Change, kg/m2, at Week 8|Change from baseline in Body Mass Index Change, kg/m2, at week 8, last observation was carried forward for individuals who withdrew from treatment early.|8 weeks|All randomized patients who took at least one dose of drug and had at least one post-baseline assessment.||kg/m2||Standard Deviation|Mean
701578|NCT00054717|Secondary|Virologic Response (VL < 400 Copies/ml) at Week 80|Percentage of participants with Viral Load < 400 copies/mL|Week 80|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
701053|NCT00053703|Primary|Change From Baseline in PANSS Negative Symptom Subscale at Week 8|The PANSS (described above) includes 7 items that reflect negative psychotic symptoms such as amotivation and social withdrawal. As are all items within the PANSS, items are categorically rated by the clinician between 0 - no symptoms to 7 extreme symptoms. The minimal score is 0 reflecting no positive symptoms to 49 reflecting that all items were extreme. Higher scores reflect more severe symptoms. Scores above 18 are usually clinically significant.|8 weeks|||units on a scale||Standard Deviation|Mean
701054|NCT00053703|Primary|Change From Baseline in PANSS Positive Symptom Subscale Score at 8 Weeks.|The PANSS (described above) includes 7 items that reflect positive psychotic symptoms such as hallucinations and delusions. As are all items within the PANSS, items are categorically rated by the clinician between 0 - no symptoms to 7 extreme symptoms. The minimal score is 0 reflecting no positive symptoms to 49 reflecting that all items were extreme. Higher scores reflect more severe symptoms. Scores above 18 are usually clinically significant.|8 weeks|All randomized patients who took at least one dose of drug and had at least one post-baseline assessment.||units on a scale||Standard Deviation|Mean
701055|NCT00053703|Secondary|Change From Baseline in Barnes Akathisia Scale at Week 8|Barnes Akathisia Scale is a clinician rated scale which considers information based on observation of the participant as well as participant report. The scale includes 3 items rated between 0- none to 3 severe and 1 summary item rated between 0 none to 5 severe. All items are summed to obtain the total score. The minimal total score is 0 and the maximal score is 14 with higher scores reflecting more severe akathisia. A score of 4 or more is clinically significant.|8 weeks|All randomized patients who took at least one dose of drug and had at least one post-baseline assessment.||units on a scale||Standard Deviation|Mean
701056|NCT00053703|Secondary|Change From Baseline in Weight at Week 8|change in weight from baseline to week 8 in kg|8 weeks|All randomized patients who took at least one dose of drug and had at least one post-baseline assessment.||Kg||Standard Deviation|Mean
701057|NCT00053703|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at 8 Weeks|Assessed with the Positive and Negative Syndrome Scale in which a clinician rates various psychotic symptoms on the basis of observation of the participant, interview with the participant, and review of all other available information including informant reports. The scale consists of 30 items which are rated categorically between 1 - no symptoms to 7 - extreme symptoms. The minimal score is 0 and the maximal score is 210, with higher scores reflecting more symptoms. Typically scores > that 60 are considered clinically significant.|8 weeks|All randomized patients who took at least one dose of drug and had at least one post-baseline assessment.||units on a scale||Standard Deviation|Mean
701058|NCT00057941|Primary|Clinical Benefit Rate|Clinical benefit = complete response (CR), partial response (PR), or stable disease (SD) lasting for at least 6 months, assessed per Response Evaluation Criteria of Solid Tumor (RECIST).CR=disappearance of all target and non-target lesions. PR= disappearance of or at least 30% decrease in the sum of the longest diameters of target lesions, with non-progressive disease in non-target lesions. SD= sum of the longest diameters of target lesions decrease <30% or increase <20%, with non-progressive disease in non-target lesions. 141 eligible, treated patients were included.|assessed every 3 cycles while on treatment, assessed every 3 months when follow up <2 years, every 6 months between 2-3 years,no specific requirements after 3 years|141 eligible and treated patients, 72 on Arm I (Anastrozole and ZD1839) and 69 on Arm II (Fulvestrant and ZD1839)||percentage of participants||95% Confidence Interval|Number
701059|NCT00057954|Secondary|Progression-free Survival|Progression-free survival was defined as time from enrollment to disease progression or death from any cause, whichever occurred first. Patients who did not have progression-free survival events were censored at last date of disease assessment.|Assessed day 100 post transplant and every 3 months during year 1, every 6 months during years 2-3, then every 12 months during years 4-5 or through diagnosis of disease progression|all 6 enrolled patients||days||95% Confidence Interval|Median
701060|NCT00057954|Secondary|100-day Overall Survival|Proportion of patients who survived 100 days or more after enrolled on the study|Assessed at least twice a week for the first 60 days and weekly until day 100.|all 6 enrolled patients||Proportion of participants||95% Confidence Interval|Number
701061|NCT00057954|Primary|Proportion of Participants With Successful Engraftment||Assessed daily during inpatient stay|all enrolled 6 patients||Proportion of participants||95% Confidence Interval|Number
701062|NCT00058019|Secondary|Time to Progression|Defined as the time from the first day of treatment until the date PD(progressive disease) or death is first reported. Patients who died without a reported prior progression was considered to have progressed on the day of their death. Patients who did not progress was censored at the day of their last tumor assessment. According to the 1999 international response criteria as published by Cheson, progression/progressive disease is defined as >=50% increase from nadir in the sum of the products of the greatest diameters of any previously identified abnormal node for PRs or nonresponders, or appearance of any new lesion during or at the end of therapy.|up to 3 years|||Days||95% Confidence Interval|Median
701063|NCT00058019|Secondary|Overall Survival|Defined as the time from the first day of therapy to the date of death. If the patient was lost to follow-up, survival was censored on the last date the patient was known to be alive.|up to 3 years|||Days||95% Confidence Interval|Median
701064|NCT00058019|Secondary|Duration of Response|Duration of response was measured from the time measurement criteria are met for CR(complete response)/CRu(unconfirmed complete response)/PR(partial response), whichever was first recorded, until the first date that PD(progressive disease) was objectively documented. According to the 1999 international response criteria as published by Cheson, CR/CRu is defined as the disappearance of all target lesions; PR is defined as >=50% decrease in the sum of the products of the greatest diameters; PD is defined as >=50% increase from nadir in the sum of the products of the greatest diameters of any previously identified abnormal node for PRs or nonresponders, or appearance of any new lesion during or at the end of therapy.|up to 3 years|||Days||95% Confidence Interval|Median
701065|NCT00058019|Primary|Safety and Toxicity of Ixabepilone|Number of patients experiencing adverse event grade 3 or above. Grade was determined by the National Cancer Institute Common Toxicity Criteria (CTC) version 2.0. Adverse events possibly, probably, or definitely attributed to use of ixabepilone.|up to 3 years|||participants|||Number
701089|NCT00058825|Secondary|2-year Relapse-free Survival|Relapse-free survival (RFS) was calculated from the time of transplant to the date of relapse, death, or last follow-up, whichever occurred first. Survival data were analyzed by Kaplan-Meier method.|2 years|||percentage of participants||95% Confidence Interval|Number
701066|NCT00058019|Primary|Objective Overall Response Rate|The 1999 international response criteria (http://www.ncbi.nlm.nih.gov/pubmed/10561185) as published by Cheson was used for the definition of target lesions and CT scans were used for response assessment. CR(complete response)/CRu(unconfirmed complete response) requires disappearance of all target lesions; PR (partial response) requires >=50% decrease in the sum of the products of the greatest diameters; Overall Response (OR)=CR/CRu+PR.|up to 3 years|||participants|||Number
701067|NCT00058214|Secondary|Time to Progression|Estimated using the product-limit method of Kaplan and Meier. Progression was defined as the appearance of ≥ 1 new lesion on radiographs consistent with metastatic disease, an absolute increase in PSA value of 5 ng/mL relative to the lowest postenrollment PSA value (including the baseline PSA value), or if the PSA doubling time was < 2 months.|From the date of registration to the date of documented PSA progression, assessed up to 6 years|||months||95% Confidence Interval|Median
701068|NCT00058214|Primary|PSA Response|A PSA normalization (PSA-N) - was recorded on case report forms for any evaluation in which the PSA level was undetectable (< 0.1 ng/mL). If the PSA-N response was confirmed by a second measurement ≥ 4 weeks later, the patient’s best PSA response was considered PSA-N. PSA-PR was recorded if the PSA decreased by ≥ 50% from baseline (pretreatment) values and confirmed by a second measurement ≥ 4 weeks later. PSA-PD was recorded upon the appearance of ≥ 1 new lesion on radiographs consistent with metastatic disease, an absolute increase in PSA value of 5 ng/mL relative to the lowest postenrollment PSA value (including the baseline PSA value), or if the PSA doubling time was < 2 months. PSA-SD constituted responses that did not qualify for PSA-N, PSA-PR, or PSA-PD. Response = PSA-N + PSA-PR.|Up to 6 years|||percentage of participants|||Number
701069|NCT00058240|Secondary|Overall Response Rate (CR + PR) of Flavopiridol in Patients Evaluated Utilizing the Revised National Cancer Institute-sponsored Working Group Guidelines|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Up to 2 years|||patients|||Number
701070|NCT00058240|Primary|Recommended Dose Level of Flavopiridol|Recommended dose determined by number of DLTs [non-hematologic toxicity grade 3 or greater (excluding not life-threatening transient liver function or transient electrolyte abnormalities, fatigue, or diarrhea resolving within 4 days), some grade 2 toxicity (i.e. irreversible renal, chronic pulmonary, neurologic, or cardiac toxicity), hematologic toxicity of grade 4 thrombocytopenia/neutropenia persisting for 7 days or greater, or inability to continue cycle 2 by 7 weeks for reasons other than disease progression] and consideration of number of patients with severe tumor lysis requiring hemodialysis with dose 1.|Up to 6 weeks|||mg/m^2|||Number
701071|NCT00058240|Primary|Number of Patients With Dose Limiting Toxicities (DLTs)|DLTs were defined as non-hematologic toxicity of grade 3 or greater severity (excluding transient liver function abnormalities, transient electrolyte abnormalities that are not life threatening, fatigue, or diarrhea that resolve within 4 days), or in some case grade 2 toxicity (i.e. irreversible renal, chronic pulmonary, neurologic, or cardiac toxicity). Hematologic toxicity were evaluated by the modified NCI criteria and followed closely. Dose limiting only if grade 4 thrombocytopenia or neutropenia persists for 7 days or greater. Inability to continue with cycle 2 by 7 weeks for reasons other than progression of disease will also be considered a DLT.The National Cancer Institute Common Toxicity Criteria will be used to characterize toxicity.|up to 7 weeks|||patients|||Number
701072|NCT00058539|Secondary|Serum Concentrations of Pertuzumab||Assessed at pre-dose, 15-minutes postdose on Day 1 (Cycle 1), Day 22 (Cycle 2), Day 43 (Cycle 3), Day 85 (Cycle 5), and Day 169 (Cycle 9); pre-dose on Day 253 (Cycle 13), and on Days 8, 15, 29 and 36|Pharmacokinetic evaluable participants||micrograms per milliliter (µg/mL)||Standard Deviation|Mean
701073|NCT00058539|Secondary|Percentage of Participants Who Progressed at 3, 6 and 9 Months|Per RECIST, disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of longest diameter recorded since the treatment started or the appearance of 1 or more new lesions, and/or unequivocal progression of existing non-target lesions. Percentage of participants who were free from disease progression was calculated by subtracting the number of participants with disease progression at that time point from the total population at risk of disease progression, multiplied by 100.|3, 6, and 9 months|Efficacy analysis population||percentage of participants|||Number
701074|NCT00058539|Secondary|Duration of Response|Duration of response was defined as the time from the initial CR or PR to the time of disease progression.|Screening, Day 1 of Cycles 1-17, and at 30 days after the last dose of pertuzumab|No participants experienced either CR or PR.|||||
701075|NCT00058539|Secondary|Median Time of PFS|PFS was defined as the time from the first day of study drug treatment to the time of documented disease progression or death, whichever came first. Participants who were lost to follow-up or who had not progressed at the time of study completion or early termination were censored at the date of last tumor assessment.|Screening, Day 1 of Cycles 1-17, and at 30 days after the last dose of pertuzumab|Efficacy analysis population. Five participants were censored for this analysis.||weeks||95% Confidence Interval|Median
701076|NCT00058539|Secondary|Percentage of Participants With Disease Progression or Death (Progression Free Survival [PFS])|PFS was defined as the time from the first day of study drug treatment to the time of documented disease progression or death, whichever came first. Participants who were lost to follow-up or who had not progressed at the time of study completion or early termination were censored at the date of last tumor assessment. The percentage of participants experiencing disease progression or death was calculated as the number of participants with an event divided by the number of participants analyzed, multiplied by 100.|Screening, Day 1 of Cycles 1-17, and at 30 days after the last dose of pertuzumab|Efficacy analysis population. Five participants were censored for this analysis.||percentage of participants|||Number
701077|NCT00058539|Primary|Kaplan Meier Estimate of Percentage of Participants With Disease Progression at 3 Months|Per RECIST, disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of longest diameter recorded since the treatment started or the appearance of 1 or more new lesions, and/or unequivocal progression of existing non-target lesions.|3 months|Efficacy analysis population.||percentage of participants|||Number
701090|NCT00058825|Secondary|Chronic Graft Versus Host Disease|Number of patients with Chronic Graft Versus Host Disease within 1 year post-transplant|1 year|||participants|||Number
701078|NCT00058539|Primary|Percentage of Participants With a Best Overall Confirmed Response of Complete Response (CR) or Partial Response (PR) Based on Response Evaluation Criteria in Solid Tumors (RECIST) and Prostate Specific Antigen (PSA) Response Rate Based on Bubley Criteria|Response by tumor measurement occurred if there was documented and confirmed CR or PR. Response was assessed by both the RECIST and by PSA levels measurement, based on measurable or non-measurable disease at baseline. Per RECIST, CR: disappearance of all target and non-target lesions and normalization of tumor marker level; PR: at least a 30 percent (%) decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter. A PSA response was defined as a PSA decline of greater than or equal to (≥) 50%, which had to be confirmed by a second PSA value at least 4 weeks later.|Screening, Day 1 of Cycles 1-17, and at 30 days after the last dose of pertuzumab|Efficacy analysis population: All participants who received at least 1 dose of study drug and either underwent at least 1 postbaseline assessment of response or died within 30 days after the last study treatment before any evaluation of response.||percentage of participants||95% Confidence Interval|Number
701079|NCT00058552|Secondary|Kaplan Meier Estimate of Percentage of Participants Who Were Free of Disease Progression at 3, 6, and 12 Months|Per RECIST v 1.1, disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions, and/or unequivocal progression of existing non-target lesions.|3, 6, and 12 months|Efficacy Analysis Population.||percentage of participants|||Number
701080|NCT00058552|Secondary|Overall Survival|Survival was the interval of time from date of first dose of study medication to date of death at any time. Participants who had not died were censored at the date of last contact when they were known to be alive.|Days 1, 8, and 15 of Cycles 1 and 2, Day 1 of Cycles 3-17, follow-up (30 days after the last dose of pertuzumab) and then every 3 months until death or loss to follow-up (up to 5 years)|Efficacy Analysis Population. Seventeen participants in pertuzumab 420 mg arm and 33 participants in pertuzumab 1050 mg were censored for this analysis.||weeks||95% Confidence Interval|Median
701081|NCT00058552|Secondary|Percentage of Participants Who Died|The percentage of participants experiencing death was calculated as the number of participants with event divided by the number of participants analyzed, multiplied by 100.|Days 1, 8, and 15 of Cycles 1 and 2, Day 1 of Cycles 3-17, follow-up (30 days after the last dose of pertuzumab) and then every 3 months until death or loss to follow-up (up to 5 years)|Efficacy Analysis Population.||percentage of participants|||Number
701082|NCT00058552|Secondary|Duration of Response|Duration of response was defined as the time from the initial CR or PR to the time of disease progression.|Screening and prior to infusion at Cycles 3, 5, 7, 9, 13, and 17 and at follow-up (30 days after the last dose of pertuzumab)|Only responders (CR or PR) were included in the analysis.||weeks||95% Confidence Interval|Median
701083|NCT00058552|Secondary|Median Time of PFS|PFS was defined as the time from the first day of study drug treatment to the time of documented disease progression or death, whichever came first. Participants who were lost to follow-up or who had not progressed at the time of study completion or early termination were censored at the date of last tumor assessment.|Screening and prior to infusion at Cycles 3, 5, 7, 9, 13, and 17 and at follow-up (30 days after the last dose of pertuzumab)|Efficacy Analysis Population. Six participants in pertuzumab 420 mg treatment arm and 15 participants in pertuzumab 1050 mg treatment arm were censored for this analysis.||weeks||95% Confidence Interval|Median
701084|NCT00058552|Secondary|Percentage of Participants With Disease Progression or Death (Progression Free Survival [PFS])|PFS was defined as the time from the first day of study drug treatment to the time of documented disease progression or death, whichever came first. Participants who were lost to follow-up or who had not progressed at the time of study completion or early termination were censored at the date of last tumor assessment. The percentage of participants experiencing disease progression or death was calculated as the number of participants with event divided by the number of participants analyzed, multiplied by 100.|Screening and prior to infusion at Cycles 3, 5, 7, 9, 13, and 17 and at follow-up (30 days after the last dose of pertuzumab)|Efficacy Analysis Population. Six participants in pertuzumab 420 mg treatment arm and 15 participants in pertuzumab 1050 mg treatment arm were censored for this analysis.||percentage of participants|||Number
701085|NCT00058552|Primary|Percentage of Participants With Best Overall Response of Complete Response (CR) or Partial Response (PR) Determined by Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 or Cancer Antigen 125 (CA-125) Changes|Response by tumor measurement occurred if there was documented and confirmed CR or PR determined by 2 consecutive investigator assessments that were at least 28 days apart. Response was assessed by either the RECIST v 1.1 or by CA-125 changes, based on measurable or non-measurable disease at baseline. Per RECIST v 1.1 (for measurable disease), CR: disappearance of all target and non-target lesions and normalization of tumor marker level; PR: at least a 30 percent (%) decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Per CA-125 changes (for non-measurable disease), CR: decrease in the CA-125 to within the normal limits and less than (<) 40 international units per milliliter (IU/mL) and no clinical or radiological evidence of disease, PR: a greater than (>) 50 percent (%) decrease in CA-125 values from baseline, and no clinical or radiological evidence of new lesions.|Screening and prior to infusion at Cycles 3, 5, 7, 9, 13, and 17 and at follow-up (30 days after the last dose of pertuzumab)|Efficacy Analysis Population: All participants who received at least 1 dose of study drug and either underwent at least one postbaseline assessment of response or died within 30 days after the last study treatment before any evaluation of response.||percentage of participants||95% Confidence Interval|Number
701086|NCT00058825|Secondary|Median Time to Engraftment With the Isolex/CLINIMACs System|Engraftment was defined as the day of absolute neutrophil counts (ANC) exceeded 0.5 X 10^9/L on the first of 3 days.|30 days|||days||Full Range|Median
701087|NCT00058825|Secondary|Number of Patients Who Engrafted With the Isolex/CLINIMACs System|Engraftment was defined as the day of absolute neutrophil counts (ANC) exceeded 0.5 X 10^9/L on the first of 3 days.|30 days|||participants|||Number
701088|NCT00058825|Secondary|2-year Overall Survival|Overall survival (OS) was calculated from the time of transplant to death from any cause or censored at last follow-up. Survival data were analyzed by Kaplan-Meier method.|2 years|||percentage of participants||95% Confidence Interval|Number
701091|NCT00058825|Secondary|Acute Graft Versus Host Disease|Number of patients with Acute Graft Versus Host Disease within 100 days post-transplant|100 days|||participants|||Number
701095|NCT00059215|Secondary|Number of Participants With Non-CABG TIMI Major or Minor Bleeding Plus MACE|"Number of participants with non-coronary artery bypass graft (non-CABG) Thrombolysis In Myocardial Infarction (TIMI) Major or Minor bleeding or MACE.
Major bleed was defined as an intracranial hemorrhage OR a clinically overt hemorrhage with a >5 g/dL decrease in hemoglobin.
Minor bleed was defined as a clinically overt hemorrhage with a hemoglobin decrease >=3 g/dL and <= 5 g/dL.
MACE is any of the following:death, nonfatal myocardial infarction, stroke, total or subtotal occlusion of the target vessel, urgent target vessel revascularization, recurrent ischemia requiring hospitalization"|randomization though 30 days after percutaneous coronary intervention (PCI)|||participants|||Number
701096|NCT00059215|Secondary|Number of Participants With Non-Coronary Artery Bypass Graft (Non-CABG) Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding|"Number of participants with non-coronary artery bypass graft (non-CABG) Thrombolysis In Myocardial Infarction (TIMI) Major or Minor bleeding.
A major bleed was defined as an intracranial hemorrhage OR a clinically overt hemorrhage with a >5 g/dL decrease in hemoglobin."|randomization though 30 days after percutaneous coronary intervention (PCI)|||participants|||Number
701097|NCT00059215|Secondary|Number of Participants With Major Adverse Cardiovascular Events (MACE)|Number of participants with any of the following: death, nonfatal myocardial infarction, stroke, total or subtotal occlusion of the target vessel, urgent target vessel revascularization, recurrent ischemia requiring hospitalization.|randomization though 30 days after percutaneous coronary intervention (PCI)|||participants|||Number
701098|NCT00059215|Primary|Number of Participants With Non-coronary Artery Bypass Graft (Non-CABG) Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding Events|"Number of participants with non-coronary artery bypass graft (non-CABG) Thrombolysis In Myocardial Infarction (TIMI) Major or Minor bleeding.
A major bleed was defined as an intracranial hemorrhage OR a clinically overt hemorrhage with a >5 g/dL decrease in hemoglobin.
A minor bleed was defined as a clinically overt hemorrhage with a hemoglobin decrease >=3 g/dL and <= 5 g/dL."|randomization though 30 days after percutaneous coronary intervention (PCI)|Patients who received at least one dose of study drug||participants|||Number
701099|NCT00059332|Secondary|Mortality||3 months|||participants|||Number
701100|NCT00059332|Secondary|Symptomatic Intracranial Hemorrhage||3 month|||participants|||Number
701101|NCT00059332|Secondary|Serious Adverse Events||3 months|||participants|||Number
701102|NCT00059332|Secondary|Stroke Impact Scale|"The Stroke Impact Scale (SIS) is a measure of stroke-specific quality of life. The scale assesses 8 domains. Scores for each domain range from 0-100, with higher scores indicating better outcomes.
Physical problems
Memory and thinking
Mood and emotions
Communication, reading and understanding
Daily activities
Mobility at home and in the community
Affected hand use
Hobbies and activities participation"|3 months|||units on a scale||Inter-Quartile Range|Median
701103|NCT00059332|Secondary|Barthel Index|"The Barthel Index is a measure of activities of daily living. Total score is calculated by addition of subscale scores. Total score range is 0-100, with higher scores indicating better outcomes. The ten subitems are:
FEEDING (Subscale range is 0-10) BATHING (Subscale range is 0-5) GROOMING (Subscale range is 0-5) DRESSING (Subscale range is 0-10) BOWELS (Subscale range is 0-10) BLADDER (Subscale range is 0-10) TOILET USE (Subscale range is 0-10) TRANSFERS (Subscale range is 0-15) MOBILITY (Subscale range is 0-15) STAIRS (Subscale range is 0-10)"|3 months|||units on a scale||Inter-Quartile Range|Median
701104|NCT00059332|Secondary|NIH Stroke Scale|"The National Institute of Health Stroke Scale (NIHSS) is a measure of neurologic deficit. Total Score range 0-42, with higher scores indicating greater severity. The 11 domains assessed are:
1a-c Level of consciousness 2. Best Gaze 3. Visual 4. Facial Palsy 5a. Motor left arm 5b. Motor right arm 6a. Motor left leg 6b. Motor right leg 7. Limb Ataxia 8. Sensory 9. Best Language 10. Dysarthria 11. Extinction and Inattention"|3 months|||units on a scale||Inter-Quartile Range|Median
701105|NCT00059332|Secondary|Modified Rankin Score ≤2|Functional independence based on modified Rankin score|3 months|||participants|||Number
701106|NCT00059332|Secondary|Modified Rankin Score of 0 or 1|Minimal or no disability based on the modified Rankin score|3 months|||participants|||Number
701107|NCT00059332|Primary|Modified Rankin Scale|"Modified Rankin Scales (mRS) is a measure of global disability. Total Scale range is 0-6, with lower values indicating better outcomes.
0 No symptoms at all
No significant disability despite symptoms; able to carry out all usual duties and activities
Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance
Moderate disability; requiring some help, but able to walk without assistance
Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance
Severe disability; bedridden, incontinent and requiring constant nursing care and attention
Dead"|3 months after stroke onset|||units on a scale||Inter-Quartile Range|Median
701108|NCT00059475|Primary|Response Rate|Response is measured from the time measurement criteria are first met for complete response (CR) or partial response (PR) (whichever is first) until the first date that recurrent disease is objectively documented. Complete response is the disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.|6 years|The number of participants analyzed and results are correct. We do not have the response rate data for all patients.||participants|||Number
701109|NCT00059475|Secondary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For details about the adverse events see the adverse event module.|11 months|||Participants|||Number
701110|NCT00059475|Primary|Immunologic Response Rate|Immunologic monitoring will be conducted using in vitro sensitization assays. The immunologic response in these assays will be considered positive if at least a two-fold increase in vaccine specific interferon gamma (y-IFN) secretion is seen between post vaccination specimens compared to the pre vaccination specimens.|11 months|The number of participants analyzed and results are correct. We do not have the immunologic response rate data for all patients.||Participants|||Number
701111|NCT00059787|Secondary|To Determine the Tolerability of Twelve Months of Maintenance Treatment||Twelve months of maintenance|||participants|||Number
701112|NCT00059787|Secondary|To Determine Progession Free Survival With the Addition of OSI-774 (Tarceva) to the Combination of Paclitaxel and Carboplatin||The duration of the study|||months||95% Confidence Interval|Median
701113|NCT00059787|Secondary|To Measure EGFR Gene Amplification in Tumor Specimens||The duration of the study for up to 7 years|Tumor specimens were evaluated for EGFR gene amplification in 20 patients||number of tumor specimens|||Number
701116|NCT00059839|Primary|Event-free Survival (EFS)|Percentage of EFS patients. This is measured as the time from study entry until disease progression, disease recurrence, occurrence of a second malignant neoplasm, or death from any cause. To measure Event Free Survival, repeated one-sided logrank tests will be performed The upper critical values are based on the one-sided alpha-spending functions of t2 (alpha=0.05) and the lower critical values are based on testing the alternative hypothesis at 0.005 level.|From first enrollment up to 3 years.|64 patients from Arm I were analyzed for this outcome measure, one patient was deemed ineligible. 61 patients from Arm II were analyzed for this outcome measure, three patients were deemed ineligible.||percentage of participants||95% Confidence Interval|Number
701117|NCT00060008|Primary|Tumor Progression as Measured by Tumor Area and Volume at 1 Year.|We correlated SUVmax and change in tumor volume over the subsequent year|One year|||percentage of change|Participants|Full Range|Median
701118|NCT00060333|Secondary|Change in Fatigue From Baseline to 3 Months as Assessed by the Brief Fatigue Inventory|Fatigue Assessment: A portion of the Brief Fatigue Inventory will be used to determine fatigue changes throughout the course of radiation. Patients will fill out the questionnaire at baseline, weekly during radiation, and 3 months after the beginning of radiation. Fatigue will be defined as: minor if the patient answers 0-3 (on a 10 point scale), mild for answers of 4-6, and severe for answers of 7-10. The percentage of patients that have worsened (improved) fatigue from baseline to the radiation stage will be calculated. We will also compare fatigue levels at baseline to the 3 month visit. Worsened fatigue is defined as going from minor to mild, minor to severe, or mild to severe. Improved fatigue is defined as going from severe to mild, severe to minor, or mild to minor.|Baseline to up to 3 months|||percentage of participants analyzed|||Number
701119|NCT00060333|Secondary|Toxicity|For this secondary endpoint, toxicity is defined as a grade 3 or higher adverse events that is classified as either possibly, probably, or definitely related to study treatment. The assignment of attribution to study treatment and grade (or degree of severity) of the adverse event are classified using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 2.0. The number of participants reporting a grade 3 or higher toxicity are reported. For a list of all reported adverse events, please refer to the Adverse Events Section below.|Up to 5 years|||number of participants|||Number
701120|NCT00060333|Secondary|Failure Time|Failure time is defined as the time from randomization to death due to any cause or disease progression. The median failure time will be estimated using the method of Kaplan-Meier.|Time from randomization to death due to any cause or disease progression (up to 5 years)|||||95% Confidence Interval|Median
701121|NCT00060333|Secondary|Survival Time|Survival time: Survival time is defined as the time from randomization to death due to any cause. The median survival time will be estimated using the method of Kaplan-Meier.|up to 5 years|||||95% Confidence Interval|Median
701122|NCT00060333|Secondary|Incidence of Regional and Systemic Metastases|Incidence of regional and systemic metastasis: Incidences will be calculated for each cohort and 95% confidence intervals will be constructed using the properties of the binomial distribution.|Up to 5 years|||percentage of patients||95% Confidence Interval|Number
701123|NCT00060333|Primary|2-year Local Recurrence Rate (LRR)/Incidence of Local Recurrence|The primary endpoint is the incidence of local recurrence within 2 years after treatment. Local recurrence (LR) is defined as a desmoplastic melanoma lesion recurring within the radiated field. The properties of the binomial distribution will be used to construct a 95% confidence interval for the true 2-year local recurrence rate (LRR). The Kaplan-Meier method will be used if some patients are lost to follow-up.|Within 2 years after treatment|||percentage of patients with LR||95% Confidence Interval|Number
701124|NCT00060346|Primary|Objective Response to Treatment|Objective response assessed using standard myeloma response criteria. Objective response is defined as a > 50% reduction in the quantitative IgM or M-Spike levels from baseline levels. Response must be documented by two measurements separated by at least 3 weeks.|Every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, every 12 months if patient is 6-10 years from study entry|All eligible and treated patients are included in this analysis.||proportion of participants||90% Confidence Interval|Number
701146|NCT00044005|Primary|Number of Participants With Adverse Events|The primary objective of this 6-month open-label study was to evaluate the safety of 3 doses of lurasidone.|6-months|No formal hypothesis testing was performed. However,descriptive statistics were provided and data summarized. Safety analyses were conducted on the safety population, that included all subjects who had received at least 1 dose of open-label study medication.||participants|||Number
701130|NCT00060840|Primary|The Number of Subjects With Left Ventricular Failure During Left Ventricular Assistance Device (LVAD) Placement After Cardio Pulmonary Bypass, as Determined by Failure Criteria, After Administration of Nitric Oxide.|"Failure criteria used to measure outcome includes:
Left ventricular flow rate index (LVFRI) ≤ 2.0 L/min/m^2
Administration of ≥ 20 inotropic equivalents (IE)
Mean arterial pressure (MAP) ≤ 55 mm Hg
Central venous pressure (CVP) ≥ 16 mm Hg
Percentage of mixed venous oxygen saturation (SvO2) of ≤ 55% OR failure to wean from cardio pulmonary bypass (CPB) at least once due to hemodynamic failure or death."|28 days|The analysis was determined for intent-to-treat population.||Participants|||Number
701131|NCT00043550|Primary|Hamilton Rating Scale for Depression-17 Item|Hamilton Rating Scale for Depression (HRSD) (Hamilton, 1960). We used the 17-item version of the 27-item HRSD, a measure of depression severity. The Structured Interview Guide was used to conduct the interviews (SIGH-D; Williams, 1988). The reliability and validity of the HRSD are well documented (Rabkin & Klein, 1987). Interjudge reliability as assessed by interclass correlations was .92 in our sample. Total 17-item scores could range from 17-48 with higher scores indicating greater distress.|symptoms assessed during past 7 days, measure taken at baseline, week 8 and week 16|Numbers vary from consented due to dropout prior to start of study. 156 patients consented and randomized. 11 patients did not complete at least one post-randomization measure and were therefore not included in these analyses.||units on a scale||Standard Deviation|Mean
701132|NCT00043979|Other Pre-specified|Post-Hematopoietic Stem Cell Transplant (HSCT) Radiotherapy|Site of radiotherapy (high energy radiation) and/or toxicity experienced by the participants post HSCT radiotherapy. Grading was preformed using the Modified Glucksberg Criteria.|up to 6 cycles or 168 days|G1, grade 1; G2, grade 2; G3, grade 3; G4, grade 4; G5, grade 5. 23 were analyzed because 7 donors were taken off study and stem cells not collected due to progressive disease of sibling.||Participants|||Count of Participants
701133|NCT00043979|Other Pre-specified|Number of Participants Who Experienced Graft Versus Tumor Effect (GVT)|GVT is defined as tumor response after day 42 post-transplantation without cytotoxic therapy.|up to day 100|23 were analyzed because 7 donors were taken off study and stem cells not collected due to progressive disease of sibling.||Participants|||Count of Participants
701134|NCT00043979|Secondary|Median Survival From Date of Progression|Median survival from date of progression is based on the time from on-study date until progression or last follow-up.|up to 77 months|23 were analyzed because 7 donors were taken off study and stem cells not collected due to progressive disease of sibling.||Months||Full Range|Median
701135|NCT00043979|Secondary|Best Response Post-Hematopoietic Stem Cell Transplant EOCH (Etoposide, Vincristine, Cyclophosphamide, and Doxorubicin)|Response is defined by the Response Evaluation Criteria in Solid Tumors (RECIST). RECIST criteria offer a simplified, conservative, extraction of imaging data for wide application in clinical trials. They presume that linear measures are an adequate substitute for 2-D (dimensional) methods and registers four response categories: Complete response (CR) is disappearance of all target lesions. Partial response (PR) is 30% increase in the sum of the longest diameter of target lesions. Progressive disease (PD) is 20% increase in the sum of the longest diameter of target lesions. Stable disease (SD) is small changes that do not meet above criteria. For the purposes of this study very good partial response ((VGPR) is >75% reduction in disease) was also employed.|up to 10 cycles of therapy or 280 days|EPOCH-F (Etoposide, Vincristine, Prednisone, Cyclophosphamide, Doxorubicin, and Fludarabine) was modified to EOCH and administered to 12 patients for post-transplantation disease progression.||Participants|||Count of Participants
701136|NCT00043979|Secondary|Cluster of Differentiation 4 (CD4) Reconstitution|The median CD4 count with a range of 85-1565 (absolute count) was used to determine recovery and were considered recovered if in this range. The CD4 count was established by flow cytometry testing.|Day +28-42|||mm(3)||Full Range|Median
701137|NCT00043979|Secondary|Number of Participants to Complete Conversion to >95% Donor Chimerism|Participants who tolerated the transplantation regimen and accepted >95% of the donors blood, marrow, and/or tissue.|up to 30 days|23 were analyzed because 7 donors were taken off study and stem cells not collected due to progressive disease of sibling.||Participants|||Count of Participants
701138|NCT00043979|Secondary|Two Year Survival Rate for Patients Undergoing Allo-Hematopoietic Stem Cell Transplant|Participants who are alive at two years following Allo-Hematopoietic Stem Cell Transplant.|2 years|23 were analyzed because 7 donors were taken off study and stem cells not collected due to progressive disease of sibling.||percentage of participants|||Number
701139|NCT00043979|Secondary|Median Progression Free Survival|Progression free survival was based on the time from on-study date until progression or last follow-up.|up to 77 months|23 were analyzed because 7 donors were taken off study and stem cells not collected due to progressive disease of sibling.||Months||Full Range|Median
701140|NCT00043979|Secondary|Early Post Transplantation Relapse|Participants who experienced recurrence or progression of disease following transplant.|up to 300 days|One out of 23 participants did not have a recurrence, thus was excluded from analysis.||Days||Full Range|Median
701141|NCT00043979|Secondary|Median Time to Reach a Platelet Count of 50,000/mm(3)|Days for participants to achieve a platelet count of 50,000/mm(3).|up to 43 days|||Days||Full Range|Median
701142|NCT00043979|Secondary|Median Time to Reach Absolute Neutrophil Count of 500/mm(3)|Days for participants to achieve a neutrophil count of 500/mm(3).|up to 12 days|||Days||Full Range|Median
701143|NCT00043979|Secondary|Number of Participants With Acute and Chronic GVHD|Acute GVHD as by Modified Glucksberg Criteria occurring before day 100. Chronic GVHD as per Seattle criteria occurring after day 100.|up to 5 years or death|||participants|||Number
701144|NCT00043979|Primary|Toxicity|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|16.5 months|||Participants|||Number
701145|NCT00043979|Primary|Number of Participants With Engraftment|Engraftment is defined as rapid conversion to complete donor chimerism and is assessed by blood counts and chimerism, >95% donor engraftment at day 100 in >75% of patients.|100 days|"E.g ...in >75% of patients, shown above is not a conclusion but refers to a hypothesis, the objective of the protocol.
23 were analyzed because 7 donors were taken off study and stem cells not collected due to progressive disease of sibling."||Participants|||Number
701533|NCT00054132|Other Pre-specified|Percentage of Cells Staining Positive for Phosphorylated-v-akt Murine Thymoma Viral Oncogene Homolog 1 (Akt)|Associations between markers and tumor response will be assessed by logistic regression analysis. For those markers that are statistically significant, a cut-point analysis will be performed by the maximum chi-square with p-value adjustment method to determine positive values.|Up to 12 years||||||
701147|NCT00044044|Secondary|Change From Baseline to the End of the Double-blind Treatment in the MADRS (Montgomery Asberg-Depression Scale) Scores|The MADRS is a 10-item rating scale that assesses apparent and reported sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item is scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity.|Baseline and 6 weeks|Intent-to-Treat Division of Neuropharmacological Drug Products Last Observation Carried Forward (ITT-DNDP-LOCF). The ITT-DNDP-LOCF population will include all randomized patients who received at least one dose of study medication and who had at least one efficacy evaluation at Day 3 or beyond, during the double-blind treatment period.||units on scale||Standard Error|Least Squares Mean
701148|NCT00044044|Secondary|Change From Baseline to the End of the Double-blind Treatment in the CGI-S (Clinical Global Impression of Severity) Scores|The CGI Severity (CGI-S) assesses the severity of illness of the patient relative to the particular population on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Baseline and 6 weeks|Intent-to-Treat Division of Neuropharmacological Drug Products Last Observation Carried Forward (ITT-DNDP-LOCF). The ITT-DNDP-LOCF population will include all randomized patients who received at least one dose of study medication and who had at least one efficacy evaluation at Day 3 or beyond, during the double-blind treatment period.||units on a scale||Standard Error|Least Squares Mean
701149|NCT00044044|Secondary|Change From Baseline to the End of the Double-blind Treatment in the PANSS (Positive and Negative Syndrome Scale) Scores|The PANSS Positive and Negative Syndrome Scale)is a 30-item scale that evaluates positive, negative, and other symptoms in patients with schizophrenia. Each item is rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme). Scores range from 30-210 with higher scores representing a worsening of schizophrenia.|Baseline and 6 weeks|Intent-to-Treat Division of Neuropharmacological Drug Products Last Observation Carried Forward (ITT-DNDP-LOCF). The ITT-DNDP-LOCF population will include all randomized patients who received at least one dose of study medication and who had at least one efficacy evaluation at Day 3 or beyond, during the double-blind treatment period.||units on a scale||Standard Error|Least Squares Mean
701150|NCT00044044|Primary|Change From Baseline to the End of the Double-blind Treatment in the BPRS (Brief Psychiatric Rating Scale)Total Score|"The BPRS consists of 18 ordered categorical items (from not present to extremely severe, on a 1- to 7-point scale), each developed to assess patient symptomatology in a relatively discrete symptom area. The BPRS will be extracted from the PANSS by adding the scores of the 18 items (P2 to P7, N1, N2, and G1 to G10) of the PANSS and will not be assessed separately. The minimum score on the BPRS is 18 and the maximum is 126. The higher number indicates a worsening of schizophrenia."|Baseline and 6 weeks|Intent-to-Treat Division of Neuropharmacological Drug Products Last Observation Carried Forward (ITT-DNDP-LOCF). The ITT-DNDP-LOCF population will include all randomized patients who received at least one dose of study medication and who had at least one efficacy evaluation at Day 3 or beyond, during the double-blind treatment period.||units on a scale||Standard Error|Least Squares Mean
701151|NCT00050089|Secondary|Number of Participants With New, Non-HIV Related Serious Adverse Event|New, on-study non-HIV related Serious Adverse events were compared between ARDFP (interruption) and No ARDFP (continuation)|From date of randomization until onset of secondary outcome or end of study follow-up (12/31/2007) whichever occured first, up to 6.5 years|||participants|||Number
701152|NCT00050089|Secondary|Number of Participants With a New, Non-HIV Related Serious Adverse Event|New, on-study non-HIV related Serious Adverse events were compared between Standard-ART (standard) and Mega-ART (intensification)|From date of randomization until onset of secondary outcome or end of study follow-up (12/31/2007) whichever occured first, up to 6.5 years|||participants|||Number
701153|NCT00050089|Primary|Number of Participants With New or Recurrent AIDS Event, or Death|New or recurrent AIDS event or Death were compared between No ARDFP (continuation)+Standard-ART (standard), No ARDFP (continuation)+Mega-ART (intensification), ARDFP (interruption)+Standard-ART (standard) and ARDFP (interruption)+Mega-ART (intensification)|From date of randomization until onset of primary outcome or end of study follow-up (12/31/2007) whichever occured first, up to 6.5 years|This includes participants randomized to one of the four interventions (339 via the 2X2 factorial design)||participants|||Number
701154|NCT00050089|Primary|Number of Participants With New or Recurrent AIDS Event, or Death|New or recurrent AIDS event or Death were compared between No ARDFP (continuation) and ARDFP (interruption)|From date of randomization until onset of primary outcome or end of study follow-up (12/31/2007) whichever occured first, up to 6.5 years|This includes participants randomized to No ARDFP or ARDFP (339 via the 2X2 factorial design and 0 via the UK Option Scheme)||participants|||Number
701155|NCT00050089|Primary|Number of Participants With New or Recurrent AIDS Event, or Death|New or recurrent AIDS event or Death were compared between Standard-ART (standard) and Mega-ART (intensification)|From date of randomization until onset of primary outcome or end of study follow-up (12/31/2007) whichever occured first, up to 6.5 years|This includes participants randomized to Standard-ART or Mega-ART (339 via the 2X2 factorial design and 29 via the UK Option Scheme)||participants|||Number
701156|NCT00050167|Secondary|Treatment Effectiveness at Eradicating Tumor in the Breast and Lymph Nodes|Effectiveness defined as proportion of patients who were able to have breast conserving surgery (BCS) after preoperative therapy compared to total number of participants.|7 years||||||
701157|NCT00050167|Secondary|Proportion of Participants With Pathological Complete Response|Safety of 2 Different Treatments determined by proportion of participants who achieved pathological complete response (pCR) between two different treatments; where pCR was defined as no histopathologic evidence of any residual invasive cancer cells in the breast and axillary lymph nodes.|7 Years||||||
701158|NCT00050167|Primary|Percentage of Participants With Reoccurrence|Percentage of participants where number with local recurrence, distant metastasis, or death of any cause at 50 months is divided by total number of participants and used as primary efficacy end point to compare paclitaxel to combination docetaxel and capecitabine in breast cancer treatment for preventing recurrence (return of cancer).|Median of 50 months|"(WP Arm):301 included in the intent to treat analysis and 297 included in the safety analysis.
(DX Arm):300 included in the intent to treat analysis and 292 included in the safety analysis."||participants||95% Confidence Interval|Log Mean
701551|NCT00054327|Secondary|Incidence of Recurrent Disease|Number of patients that have disease recurrence.|at day 100 post transplant|||participants|||Number
701159|NCT00060944|Secondary|Overall Survival|The below table shows Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression.|From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years|All participants who were randomly assigned to one of the two schedules, independent of whether they received trabectedin or not.||months||95% Confidence Interval|Median
701160|NCT00060944|Secondary|Progression-Free Survival - Independent Review|The below table shows Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression.|From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years|All participants who were randomly assigned to one of the two schedules, independent of whether they received trabectedin or not.||months||95% Confidence Interval|Median
701161|NCT00060944|Secondary|Duration of Response - Independent Review|Duration of response based on assessment of confirmed CR or confirmed PR according to RECIST. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as greater than or equal to 30 percent decrease in sum of the LD of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study greater than or equal to 4 weeks after initial documentation of response. Kaplan-Meier estimation of response duration was used to account censored participants with ongoing response.|From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years|All participants who were randomly assigned to one of the two schedules, independent of whether they received trabectedin or not. Participants with confirmed response only were analyzed.||Months||95% Confidence Interval|Median
701162|NCT00060944|Secondary|Percentage of Participants Objective Response - Independent Review|Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as greater than or equal to 30 percent decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study greater than or equal to 4 weeks after initial documentation of response.|From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years|All participants who were randomly assigned to one of the two schedules, independent of whether they received trabectedin or not.||Percentage of participants||95% Confidence Interval|Number
701163|NCT00060944|Primary|Time to Progression- Independent Review|Time to Progression was defined as time between randomization and the first documentation of disease progression or death due to progressive disease.|From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years|All participants who were randomly assigned to one of the two schedules, independent of whether they received trabectedin or not.||months||95% Confidence Interval|Median
701164|NCT00061048|Secondary|The Number of Participants With Adverse Events|Here are the total number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|18 months|||participants|||Number
701165|NCT00061048|Secondary|Cell Surface Expression of CD52 on Tumor Cells|The CD52 antibody-binding capacity (ABC) value is the measurement of the mean value of the maximum capacity of each cell to bind the anti-CD52 and when determined under conditions of saturating levels of antibody measures number of mean surface CD52 antigens per cell. CD52 ABC is negative when 100% saturation by therapeutic antibody is achieved.|6 months|||ABC value||Standard Deviation|Mean
701166|NCT00061048|Primary|Time to Progression|Time between the first day of treatment to the day of disease progression which is defined as a persistent (at least two determinations) doubling of the peripheral blood leukemic cell count, the development of new lesions, or Ca elevations that are uncontrolled by conventional therapeutic procedures.|60 months|||months||95% Confidence Interval|Median
701167|NCT00061048|Primary|Overall Survival|Time between the first day of treatment to the day of death.|60 months|||months||95% Confidence Interval|Median
701168|NCT00061048|Primary|Overall Response Rate|"Overall response rate is defined as the percentage of participants with response and utilizes the International Standardized workshop definition.
Complete response(CR)-Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease related symptoms if present before therapy and normalization of those biochemical abnormalities (for example LDH) definitely assignable to the lymphoma.
Please see the protocol Link module for the full criteria if desired."|60 months|||percentage of participants||95% Confidence Interval|Number
701169|NCT00061633|Primary|Clinical Response Which is Measured at Test of Cure (TOC) in the Clinically Evaluable (CE) Population|"Cure: Resolution of clinically significant signs, symptoms associated with the skin infection present at study admission or improvement to the extent that the infectious process had been controlled and no further therapy with study medication was necessary.
Failure: Inadequate response to study therapy or the need for significant surgical management (e.g. more than just routine debridement) of the infection site following antibiotic therapy and prior to the Test-of-Cure (TOC) visit.
Indeterminate: Inability to determine outcome."|7-14 days following end of antibiotic treatment|"The CE population were a subset of the All Treated Population and was composed of patients who met the inclusion/exclusion criteria or were granted permission to enroll and had a clinical response of cure or failure. The All Treated Population patients received at least one treatment. The Primary Efficacy Analysis was of the CE population."||participants|||Number
701170|NCT00061893|Secondary|Event Free Survival||24 months after start of protocol therapy|By protocol design, all eligible patients who received protocol therapy were considered in the evaluation of Event Free Survival. Three (3) patients were considered ineligible. All other patients (35) started protocol therapy and are thus included in the evaluation for this measure.||percentage of participants||95% Confidence Interval|Number
701240|NCT00063635|Primary|Number of Participants With Sustained Reduction in Alanine Aminotransferase (ALT) to Either 50% of Baseline Value or < 40 IU/L|The primary outcome was sustained reduction in ALT level, defined as 50% or less of the baseline level or 40 IU/L or less at each visit from 48 to 96 weeks of treatment.|baseline and 96 weeks|All enrolled patients were included in analysis of the primary outcome, sustained reduction in ALT level. Patients missing a 96-week ALT measurement were imputed as not achieving a sustained reduction.||participants|||Number
701171|NCT00061893|Primary|Occurrence of Severe Toxicity|An incidence of severe toxicity is defined to be the occurrence of grade 3 or higher infection or grade 3 or higher sensory neuropathy during cycles 1-2 of protocol therapy. If 12 or more patients experience grade 3 or higher infection or five or more patients experience grade 3 or higher sensory neuropathy during cycles 1-2 of protocol therapy, the regimen will be flagged as being associated with an excessive rate of severe toxicity.|The first two cycles (6 weeks) of protocol chemotherapy|By protocol design, all eligible patients who received protocol therapy were considered in the evaluation of severe toxicity. Three (3) patients were considered ineligible. All other patients (35) started protocol therapy and are thus included in the evaluation for this measure.||participants|||Number
701172|NCT00061932|Secondary|Change in Patterns of Gene Expression Pre- and Post-treatment Performed by GeneChip Analysis||Baseline to 6 years||||||
701173|NCT00061932|Primary|True Response Rate Evaluated for the Combination of Irinotecan and PS341 by Response Evaluation Criteria in Solid Tumors (RECIST)|Tumor response was assessed every eight weeks by CT/MRI using RECIST (Response Evaluation Criteria in Solid Tumors) criteria|Up to 6 years|||participants||95% Confidence Interval|Number
701174|NCT00061945|Post-Hoc|Number of Participants Achieving Complete Remission|A complete remission (CR) requires the following: an absolute neutrophil count (segs and bands) > 1500/μl, no circulating blasts, platelets > 100,000/μl; bone marrow cellularity > 20% with trilineage hematopoiesis, and < 5% marrow blast cells, none of which appear neoplastic. All previous extramedullary manifestations of disease must be absent (e.g., lymphadenopathy, splenomegaly, skin or gum infiltration, testicular masses, or CNS involvement).|Duration of study (up to 10 years)|Three participants were deemed ineligible and excluded from this analysis.||participants|||Number
701175|NCT00061945|Secondary|Overall Survival (Phase II)|Will be estimated using the Kaplan-Meier method with confidence intervals presented.|3 years||||||
701176|NCT00061945|Secondary|Disease-free Survival (Phase II)|Will be estimated using the Kaplan-Meier method with confidence intervals presented.|3 years||||||
701177|NCT00061945|Secondary|Modulation of Minimal Residual Disease During Treatment With Alemtuzumab (Phase II)||Up to 10 years||||||
701178|NCT00061945|Primary|Number of Participants Who Proceed to Course V Within 2-6 Weeks of the Last Dose of Alemtuzumab (Phase II)|The primary endpoint is the number of participants who are able to proceed to course V within two - six weeks of completion of course IV.|8 months|Only participants who started Alemtuzumab were analyzed per study design. Specifically, one patient declined Alemtuzumab and was excluded from this analysis.||participants|||Number
701179|NCT00061945|Primary|Maximum Tolerated Dose (MTD) of Alemtuzumab (Phase I)|The maximum tolerated dose is defined as the highest alemtuzumab dose at which less than 40% of patients develop the dose limiting toxicity (DLT), where DLT is defined as the inability to proceed (due to medical complications) with the protocol treatment within six weeks of receiving the last dose of alemtuzumab. Groups of six patients will be enrolled into each cohort at the time of re-registration prior to starting Course IV. After a cohort has accrued 6 patients and at least 3 have completed the 2-6 week post alemtuzumab observation period without DLT, the incoming patients will be assigned to the next cohort in the table while the DLT and other toxicities continue to be assessed for the newly closed cohort. If less than 3 out of 6 enrolled patients in a cohort have completed the 2-6 week post alemtuzumab observation period without DLT, additional patients may continue to enroll in that same cohort, i.e., accrual will not be suspended while waiting for patient follow-up data.|6 weeks|Only participants who started Alemtuzumab were analyzed per study design. Specifically, one patient declined Alemtuzumab and was excluded from this analysis.||mg|||Number
701180|NCT00062010|Secondary|Progression-free Survival|Time from registration to documented disease progression (RECIST criteria) or death.|Assessed every 6 weeks|Eligible, treated patients||months||95% Confidence Interval|Median
701181|NCT00062010|Secondary|Survival|Time from registration to death.|Assessed every 3 months for 1 year then every 6 months|Eligible, treated patients||months||95% Confidence Interval|Median
701182|NCT00062010|Primary|Response by RECIST Criteria (v 1.0)|Number of eligible, treated participants in each response category by RECIST criteria|Assessed every 6 weeks|Eligible, treated patients||participants|||Number
701183|NCT00062374|Other Pre-specified|Disease Free Survival (DFS)|Overall Survival (OS) and Disease Free Survival (DFS) are the secondary endpoints. Technical problems with measurement of OS leading to unreliable or uniterpretable data. Data adjudication was invalid, and needs to be re-adjudicated. Therefore, only DFS data is being reported.|Every 3 mos for the first 2 yrs, then every 6 mos for 2 years and once a year afterwards, up to 5 years|Technical problems with measurement leading to unreliable or uninterpretable data. Data adjudication was invalid, and needs to be re-adjudicated.||months||95% Confidence Interval|Median
701184|NCT00062374|Primary|Histological Response Determined by FDG Uptake Correlates|"The primary objective was to demonstrate that a decrease in FDG-SUV discriminates treatment response. Response was defined pathologically based on microscopic inspection for residual cancer cells and fibrosis.
Using a two sample t-test, we would be able to adequately test that the decrease in SUV early in the treatment plan is significantly different between responders and non responders. Data adjudication was invalid, and needs to be re-adjudicated
Non-Responder= Tumor Regression Grade 3 or higher Responder=Tumor Regression Grade 1 (CR) or Grade 2 (PR)"|Day 15|Technical problems with measurement of FDG-SUV data leading to unreliable or uninterpretable data. Data adjudication was invalid, and needs to be re-adjudicated. Therefore, only histological response is reported.||participants|||Number
701185|NCT00062439|Secondary|Response|Response was defined as achieving a confirmed or unconfirmed complete or partial response as determined by RECIST. Patients who dropped out due to any cause prior to getting their response assessment were counted as non-responders. A complete response (CR) was defined as disappearance of all disease. A partial response was defined as a >= 30% decrease in the sum of longest diameters of target lesions. A CR or PR was defined as confirmed if two consecutive determinations were documented at least 4 weeks apart.|After completion of induction therapy.|Eligible patients who began the treatment regimen and who had measurable disease (per RECIST) at baseline were included in the analysis of response.||percentage of participants||95% Confidence Interval|Number
701241|NCT00063934|Secondary|Bcl-2 Expression in Breast Cancer Tissue|Number of participant with Bcl-2 Expression in breast cancer tissue by protein and mRNA expression before treatment and at 3-5 days after oblimersen treatment.|before treatment and at 3-5 days after oblimersen treatment|||participants|||Number
701186|NCT00062439|Secondary|Progression-Free Survival at 3 Years|Duration from date of enrollment to date of progression (per RECIST), symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free were censored at the date of last contact.|At the completion of induction therapy, then again 4 weeks after the completion of consolidation therapy, then every 3 months for 2 years, then every 6 months until up to a maximum of 5 years after enrollment.|Eligible patients who began the treatment regimen were included in the analysis.||percentage of patients||95% Confidence Interval|Number
701187|NCT00062439|Secondary|Overall Survival|The duration from the date of enrollment until the date of death due to any cause. Patients last known to be alive were censored at the date of last contact.|daily for 12 weeks then every 3 weeks for 12 weeks, then every 6 months thereafter.|Eligible patients who began the treatment regimen were included in the analysis.||years||95% Confidence Interval|Median
701188|NCT00062439|Primary|Feasibility of Treating Patients With Stage IIB/IIIB Pancoast Tumors With a Regimen of Cisplatin and Etoposide Plus Concurrent Radiotherapy Followed by Surgical Resection Followed by Consolidation Therapy With Docetaxel.|Feasibility was assessed by estimating the percentage of participants who would be able to complete the entire treatment regimen.|After completion of 5 weeks of radiotherapy given concurrently with cisplatin+etoposide, surgery + 8 weeks of recovery time, and 6 weeks of consolidation therapy with docetaxel|Eligible patients who began the treatment regimen were included in the analysis.||percentage of participants||95% Confidence Interval|Number
701189|NCT00062439|Secondary|Adverse Events|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Weekly for the first 13 weeks, then every 3 weeks for the next 6 weeks.|Eligible patients who received the study intervention.||Participants|||Number
701190|NCT00062647|Primary|Clinical Response (Cure, Failure, or Indeterminate) as Determined by the Investigator Based the Presence or Absence of Clinical Signs and Symptoms Associated With Bacteremia, Metastatic Complications, or Positive Culture at the Test of Cure Evaluation|Outcomes in this exploratory study were compared for noninferiority though no specific margin was justified. The 95% CI for the difference was -35.5 to 31.9; further statistical evaluation is not warranted owing to the small sample size.|12 weeks after start of treatment|The primary efficacy analysis was of the CE Population, defined as those patients meeting meeting inclusion/exclusion criteria, meeting continuation criteria, receiving assigned study drug for at least 14 days and available for assessment of response.||participants|||Number
701191|NCT00062738|Secondary|Percent Responders|Percent of patients who had a 50% decrease in total HDRS at 8 weeks|8 weeks|intent to treat||percent of patients who were responders|||Number
701192|NCT00062738|Primary|Hamilton Depression Scale|total score on HDRS (0-54 higher score is worse)|8 weeks|intent to treat - total patients in the arm||units on a scale||Standard Deviation|Least Squares Mean
701193|NCT00062751|Secondary|24-hour Trough Concentration (C Trough)|C trough in whole blood measured as nanograms per milliliter (ng/mL).|Cycle 1 Day 1 (1 cycle is defined as a 14 day duration) , Cycle 3 Day 1, and Cycle 4 Day 1, Day 6, Day 9, Day 11, and Day 12|ITT; Final analysis was not conducted.||ng/mL||Standard Deviation|Mean
701194|NCT00062751|Secondary|Area Under the Concentration-time Curve (AUC) Sum|Area under the concentration-time curve to infinity (AUC) measured as hours multiplied by nanograms divided by milliliters (hr*ng/mL) for CCI-779, sirolimus and letrozole. Sum is calculated as the sum of CCI-779 plus sirolimus AUCs (AUCsum).|Cycle 1 Day 1 (1 cycle is defined as a 14 day duration) , Cycle 3 Day 1, and Cycle 4 Day 1, Day 6, Day 9, Day 11, and Day 12|ITT; Final analysis was not conducted.||hr*ng/mL||Standard Deviation|Mean
701195|NCT00062751|Secondary|Number of Participants With Antitumor Response in Relation to Expression of Akt Phosphorylation, Cyclin D1, PTEN, and p27|Number of participants with antitumor response (CR [disappearance of all target and non-target lesions with normalization of tumor marker level] or PR [at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, referencing the screening sum LD]) in relation to plasma levels of Akt phosphorylation, cyclin D1, PTEN, and p27.|Prior to baseline, after Cycle 4 (Week 8), after Cycle 8 (Week 14), and cross-over or final visit (within 15 days of stopping study treatment)|ITT; Final analysis was not conducted.||participants|||Number
701196|NCT00062751|Secondary|Health Outcomes Assessment: European Organization for Research and Treatment of Cancer Quality of Life Questionaire (EORTC QLQ) BR23|Assess specificity of breast cancer symptoms relevant to participant's perceived quality of life (disease related symptoms of dry mouth, eye pain, hair loss, hot flushes, attractiveness, future health, sexual activity, arm or shoulder pain, breast pain, swollen breast, and skin problems on the breast). 23-item assessment of symptoms or problems during the past week (items 1-13 and 17-23) or during the past 4 weeks (items 14-16); range from 1 (not at all) to 4 (very much). Index scores transformed and range from 0 to 100; higher scores indicate higher level of functioning and quality of life.|Prior to baseline, Cycle 7 (Week 12) and final visit (within 15 days of stopping study treatment)|ITT; Final efficacy analysis was not conducted.||scores on a scale|||Number
701197|NCT00062751|Secondary|Health Outcomes Assessment: EuroQol (EQ-5D) Health State Profile Score|EQ-5D is a self-administered questionnaire to assess health-related quality of life in 5 domains (mobility, self care, usual activities, pain or discomfort, and anxiety or depression). Scores from the 5 domains are used to calculate the Health State Profile Score as a single index value; range: 0.0 (death) to 1.0 (perfect health); higher scores indicate a better health state.|Prior to baseline, Cycle 7 (Week 12) and final visit (within 15 days of stopping study treatment)|ITT; Final efficacy analysis was not conducted.||scores on a scale|||Number
701198|NCT00062751|Secondary|Number of Participants With Survival|Number of participants with survival (alive) in the interval from start of treatment to last contact for participant or death as a result of any cause.|Baseline, every 4 cycles (1 cycle is defined as a 14 day duration) until death|ITT; Final efficacy analysis was not conducted.||participants|||Number
701199|NCT00062751|Secondary|Duration of Response|Duration of response is measured from the time measurement criteria are met for CR or PR (whichever status is recorded first) until the first date that reoccurrence or PD is objectively documented, taking as reference for PD the smallest measurements recorded since the treatment started. SD is measured from the start of the treatment until the criteria for disease progression are met, taking as reference the smallest measurements recorded since the treatment started; the minimal time interval for duration of SD is 8 weeks.|Baseline, every 4 cycles (1 cycle is defined as a 14 day duration) up to Cycle 25, then every 6 cycles until disease progression)|ITT; Final efficacy analysis was not conducted.||days||Standard Deviation|Mean
701200|NCT00062751|Secondary|Percentage of Participants Exhibiting Freedom From Progression|Freedom from progression defined as CR (disappearance of all target and non-target lesions with normalization of tumor marker level), PR (at least a 30% decrease in sum of the LD of target lesions taking as reference the screening sum LD), or SD (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD [at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD since the treatment started; appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions]).|Baseline, 8 weeks, 6 months, 12 months, and 24 months|ITT; Final efficacy analysis was not conducted.||percentage of participants|||Number
701201|NCT00062751|Secondary|Time to Treatment Failure|Number of days to treatment failure defined as interval from start of treatment to first date of progressive disease (at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD since the treatment started; appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions) or death or discontinuation of treatment due to Adverse Event, censored at last evaluation.|Baseline until Progressive disease, death, or discontinuation of study treatment|ITT; Final efficacy analysis was not conducted.||days||Standard Deviation|Mean
701202|NCT00062751|Secondary|Time to Disease Progression|Number of days to disease progression defined as the interval from the date of randomization until the first date that recurrence or progression is documented; progression (at least 20% increase in the sum of the LD of target lesions taking as reference the smallest sum of LD; appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions).|Baseline, every 4 cycles (1 cycle is defined as a 14 day duration) up to Cycle 25, then every 6 cycles until disease progression)|ITT; Final efficacy analysis was not conducted.||days||Standard Deviation|Mean
701203|NCT00062751|Secondary|Percentage of Participants With Best Overall Response (Clinical Benefit)|Best response (CR, PR, or stable disease (SD) lasting ≥6 months) recorded from baseline to disease progression or recurrence (Progressive disease [PD]). CR=disappearance of all target and non-target lesions with normalization of tumor marker level; PR is ≥30% decrease in sum of LD of target lesions; SD=neither sufficient shrinkage to=PR nor sufficient increase to=PD, referencing smallest sum LD since treatment started; PD is ≥20% increase in sum of LD of target lesions referencing smallest sum of LD; appearance of ≥1 new lesions and/or unequivocal progression of existing non-target lesions.|Baseline, every 4 cycles (1 cycle is defined as a 14 day duration) up to Cycle 25, then every 6 cycles until disease progression)|ITT; Final efficacy analysis was not conducted.||percentage of participants||95% Confidence Interval|Number
701204|NCT00062751|Primary|Percentage of Participants With Objective Response (OR)|OR measured as Complete response (CR) or Partial response (PR) confirmed by assessments performed no less than 4 weeks after the criteria for the response are first met. CR=disappearance of all target and non-target lesions with normalization of tumor marker level; PR=at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, referencing the screening sum LD. Target lesions=all measurable lesions up to 5 lesions per organ (10 lesions in total), representative of all involved organs, if possible; recorded and measured at screening. Non-target lesions=all other lesions.|Baseline, every 4 cycles (1 cycle is defined as a 14 day duration) up to Cycle 25, then every 6 cycles until disease progression|Intent to treat population (ITT) defined as all participants randomized in the study. Final efficacy analysis was not conducted because the development of temsirolimus (CCI-779) for the treatment of breast cancer was terminated.||percentage of participants||95% Confidence Interval|Number
701205|NCT00062764|Secondary|Mean BMI Change||48 weeks|||kg/m2||Standard Deviation|Mean
701206|NCT00062764|Secondary|Average Increase in Weight After Treatment||48 weeks|||kg||Full Range|Mean
701207|NCT00062764|Secondary|Mean Increase of Insulin Sensitivity Index||48 weeks|||percentage||Standard Deviation|Mean
701208|NCT00062764|Secondary|Number of Patients With Impaired Glucose Tolerance After Treatment||48 weeks|||participants|||Number
701209|NCT00062764|Primary|Number of Patients With Improvement in Liver Histology|A histological response was defined as a reduction in the NASH activity index by 3 points or more with improvements of at least 1 point each in steatosis, parenchymal inflammation, and hepatocellular injury.|48 weeks|||participants|||Number
701210|NCT00063154|Secondary|Number of Participants Free From Disease Progression at 3, 6, and 12 Months|Disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of longest diameter recorded since the treatment started or the appearance of one or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.|Baseline to the end of the study (up to 1 year)|Efficacy-evaluable population: Participants who received at least 2 doses of pertuzumab and either underwent at least 1 post-baseline assessment of response or died as a result of disease progression before any evaluation of response.||participants|||Number
701211|NCT00063154|Secondary|Progression-free Survival|Progression-free survival was defined as the time from the first day of pertuzumab treatment (Cycle 1, Day 1) to the time of documented disease progression (per RECIST) or death, whichever occurred first.|Baseline to the end of the study (up to 1 year)|Efficacy-evaluable population: Participants who received at least 2 doses of pertuzumab and either underwent at least 1 post-baseline assessment of response or died as a result of disease progression before any evaluation of response.||weeks||95% Confidence Interval|Median
701222|NCT00063570|Secondary|Duration of (Confirmed) Complete Response or Partial Response|Duration of response is calculated as (Date of First Disease Progression or Death as a Result of any Cause whichever Comes First - Date of First Objective Status Assessment of Confirmed CR or PR + 1)/(365.25/12).|Every 6 weeks from start of treatment until documented disease progression or for 6 months from last dose of study drug, whichever occurs first. After 6 months, clinical assessment every 12 weeks and radiologic test performed as clinically indicated|Number of patients with a confirmed complete or partial response.||months||Full Range|Median
701238|NCT00063635|Secondary|Change in Nonalcoholic Fatty Liver Disease (NAFLD) Score (Histologic Feature Scores Determined by Standardized Scoring of Liver Biopsies) From Baseline at 96 Weeks of Treatment|Histological activity was assessed using the NAFLD activity score on a scale of 0 to 8, with higher scores indicating more severe disease; the components of this measure include steatosis (0-3), lobular inflammation (0-3), and hepatocellular ballooning (0-2).|baseline and 96 weeks|Number of participants analyzed reflects the number of participants with baseline and 96 week liver biopsies.||units on a scale||95% Confidence Interval|Mean
701212|NCT00063154|Secondary|Number of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD) With HER2 Phosphorylation + or - Tumors|A best overall response could occur at any time during the study and was determined by Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all target lesions (TL) or the disappearance of all non-TLs and normalization of tumor marker level. A PR was defined as at least a 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD. SD was defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since the treatment started for TLs and the persistence of 1 or more non-TL(s) and/or the maintenance of tumor marker level above normal limits. PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started or the appearance of one or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs.|Baseline to the end of the study (up to 1 year)|Efficacy-evaluable population: Participants who received at least 2 doses of pertuzumab and either underwent at least 1 post-baseline assessment of response or died as a result of disease progression before any evaluation of response.||participants|||Number
701213|NCT00063154|Primary|Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)|A best overall response could occur at any time during the study and was determined by Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all target lesions (TL) or the disappearance of all non-TLs and normalization of tumor marker level. A PR was defined as at least a 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD. SD was defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since the treatment started for TLs and the persistence of 1 or more non-TL(s) and/or the maintenance of tumor marker level above normal limits. PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started or the appearance of one or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs.|Baseline to the end of the study (up to 1 year)|Efficacy-evaluable population: Participants who received at least 2 doses of pertuzumab and either underwent at least 1 post-baseline assessment of response or died as a result of disease progression before any evaluation of response.||percentage of participants|||Number
701214|NCT00063232|Secondary|Change in Insulin Sensitivity (Glucose Tolerance, Homeostatic Model Assessment of Insulin Resistence (HOMA-IR)) From Baseline|HOMA-IR is calculated from Fasting Glucose and Fasting Insulin|from baseline to 48 weeks|||unit||Standard Deviation|Mean
701215|NCT00063232|Secondary|Change in Serum Alanine Aminotransferase (ALT) Levels From Baseline (Number of Participants in Each Change Category)|Alanine transaminase <42 U/L is considered normal|from baseline to 48 weeks|||participants|||Number
701216|NCT00063232|Primary|Change in the Histological NASH Activity Index at 48 Weeks Compared With Baseline (Number of Participants in Each Change Category)|Patients under went liver biopsy, metabolic profiling and imaging studies before and at the end 48 weeks of metformin (2000 mg/day) therapy. The primary endpoint is a three point improvement in the histological NASH activity index with a decrease in at least two of the component scores and no worsening of fibrosis or increase in Mallory bodies.|from baseline to 48 Weeks|||participants|||Number
701217|NCT00063258|Primary|Number of Patients With Response|Response defined by tumor assessment using Response Evaluation Criteria In Solid Tumors (RECIST) to learn effectiveness of Tarceva (OSI-774) when combined with standard chemotherapy before surgery.|5 Years to collect outcome information|Analysis limited since of 5 participants enrolled, only 1 evaluable for response.||Participants|||Number
701218|NCT00063362|Primary|The Proportion of Patients Who Experience a Marked and Persistent Bimodal Response|"A marked bimodal response is defined by the following three conditions over four consecutive weeks while on triple therapy and after three weeks of ltg:
Montgomery Asberg Depression Rating Scale (MADRS) total score of <= 19
Young Mania Rating Scale (YMRS) total score of <= 12.5
Global Assessment Scale (GAS) score >= 51
The MADRS measures the severity of a subject's depression symptoms with a possible total score ranging from 0 - 60, with higher scores indicating more severe depression.
The YMRS measures the severity of a subject's manic symptoms with a possible total score ranging from 0 - 60, with higher scores indicating more severe mania.
The GAS measures a used to rate subjectively the social, occupational, and psychological functioning of a subject and ranges in score from 0-100, with a higher score indicating better social, occupational, and psychological functioning."|Baseline and Week 28|||participants|||Number
701219|NCT00063570|Secondary|Overall Survival|Overall survival time is calculated as (Date of Death as a Result of any Cause - First Dose Date + 1)/ (365.25/12).|Every 6 weeks from start of treatment until documented disease progression or for 6 months from last dose of study drug, whichever occurs first. After 6 months, clinical assessment every 12 weeks and radiologic test performed as clinically indicated|||months||Full Range|Median
701220|NCT00063570|Secondary|Time to Treatment Failure|Time to treatment failure is calculated as (Date of First Disease Progression, Death as a Result of any Cause, or Early Discontinuation of Treatment Due to Adverse Event or Physician Perception of Lack of Efficacy or Patient and Physician Perception of Lack of Efficacy, whichever Comes First - First Dose Date + 1)/ (365.25/12)|Every 6 weeks from start of treatment until documented disease progression or for 6 months from last dose of study drug, whichever occurs first. After 6 months, clinical assessment every 12 weeks and radiologic test performed as clinically indicated|Intention to Treat analysis||months||Full Range|Median
701221|NCT00063570|Secondary|Time to Progressive Disease|Time to progressive disease is calculated as (Date of First Disease Progression or Death Due to Disease under Study whichever Comes First - First Dose Date + 1)/(365.25/12).|Every 6 weeks from start of treatment until documented disease progression or for 6 months from last dose of study drug, whichever occurs first. After 6 months, clinical assessment every 12 weeks and radiologic test performed as clinically indicated|Intention to Treat analysis||months||Full Range|Median
701239|NCT00063635|Secondary|Change in Serum Aspartate Aminotransferase (AST)||baseline and 96 weeks|||IU/L||95% Confidence Interval|Mean
701305|NCT00056407|Secondary|Number of Participants With Post-biopsy Macroscopic Hematuria|Participants reported events of macroscopic hematuria (visible blood in the urine) throughout the study.|Baseline to Year 4|Efficacy Population||participants|||Number
701223|NCT00063570|Primary|Overall Tumor Response|Best overall (confirmed) response recorded from start of treatment until disease progression/recurrence, start of other anti-tumor therapy/intervention, or end of trial, whichever comes first. Response must be confirmed at least 6 weeks from previous scans. Best overall response assignment depends on both measurement and confirmation criteria.|Every 6 weeks from start of treatment until documented disease progression or for 6 months from last dose of study drug, whichever occurs first. After 6 months, clinical assessment every 12 weeks and radiologic test performed as clinically indicated|Patients who received at least one dose of study drug (pemetrexed or gemcitabine) were included in the analyses.||participants|||Number
701224|NCT00063622|Secondary|Number of Participants With Resolution of Definite Nonalcoholic Steatohepatitis|The criteria for nonalcoholic steatohepatitis was definite or possible steatohepatitis (assessed by a pathologist) with an activity score of 5 or more, or definite steatohepatitis (confirmed by two pathologists) with an activity score of 4. This secondary outcome measure is the number of participants who met this definition at baseline and did not meet this definition after 96 weeks of treatment and thus had a resolution of steatohepatitis.|baseline and 96 weeks|Number of subjects with biopsy specimens at baseline and 96 weeks||participants|||Number
701225|NCT00063622|Secondary|Number of Participants With Improvement in Fibrosis|Fibrosis is assessed on a scale of 0 to 4 with higher scores indicating more severe fibrosis. This secondary outcome measure is the number of participants that experienced a decrease in fibrosis score, which indicates improvement in fibrosis.|baseline and 96 weeks|Number of subjects with biopsy specimens at baseline and 96 weeks||participants|||Number
701226|NCT00063622|Secondary|Number of Participants With Improvement in Hepatocellular Ballooning|Hepatocellular ballooning is assessed on a scale of 0 to 2 with higher scores indicating more severe hepatocellular ballooning. This secondary outcome measure is the number of participants that experienced a decrease in hepatocellular ballooning score, which indicates improvement in hepatocellular ballooning.|baseline and 96 weeks|Number of subjects with biopsy specimens at baseline and 96 weeks||participants|||Number
701227|NCT00063622|Secondary|Number of Participants With Improvement in Lobular Inflammation|Lobular inflammation is assessed on a scale of 0 to 3 with higher scores indicating more severe lobular inflammation. This secondary outcome measure is the number of participants that experienced a decrease in lobular inflammation score, which indicates improvement in lobular inflammation.|baseline and 96 weeks|Number of subjects with biopsy specimens at baseline and 96 weeks||participants|||Number
701228|NCT00063622|Secondary|Number of Participants With Improvement in Steatosis|Steatosis is assessed on a scale of 0 to 3 with higher scores indicating more severe steatosis. This secondary outcome measure is the number of participants that experienced a decrease in steatosis score, which indicates improvement in steatosis.|baseline and 96 weeks|Number of subjects with biopsy specimens at baseline and 96 weeks||participants|||Number
701229|NCT00063622|Primary|Number of Participants With Improvement in Non-alcoholic Fatty Liver Disease (NAFLD) Activity Defined by Change in Standardized Scoring of Liver Biopsies at Baseline and After 96 Weeks of Treatment.|Total nonalcoholic fatty liver disease (NAFLD) activity was assessed on a scale of 0 to 8, with higher scores indicating more severe disease; the components of this measure include steatosis (assessed on a scale of 0 to 3), lobular inflammation (assessed on a scale of 0 to 3), and hepatocellular ballooning (assessed on a scale of 0 to 2). The primary outcome was an improvement in histological findings from baseline to 96 weeks, which required an improvement by 1 or more points in the hepatocellular ballooning score; no increase in the fibrosis score; and either a decrease in the activity score for nonalcoholic fatty liver disease to a score of 3 or less or a decrease in the activity score of at least 2 points, with at least a 1-point decrease in either the lobular inflammation or steatosis score.|baseline and 96 weeks|All randomized participants were included in the analysis of the primary outcome.||participants|||Number
701230|NCT00063635|Secondary|Change in QOL- Psychosocial Health|Change in self-reported QOL physical health Pediatric Quality of Life Inventory (version 4.0) scores were recorded to range from 0 to 100 with increasing scores indicating better quality of life.|baseline and 96 weeks|||units on a scale||95% Confidence Interval|Mean
701231|NCT00063635|Secondary|Change in Quality of Life (QOL) Scores- Physical Health|Change in self-reported QOL physical health Pediatric Quality of Life Inventory (version 4.0) scores were recorded to range from 0 to 100 with increasing scores indicating better quality of life.|baseline and 96 weeks|||units on a scale||95% Confidence Interval|Mean
701232|NCT00063635|Secondary|Change in Serum Vitamin E Levels|Change in alpha-Tocopherol|baseline and 96 weeks|||mg/L||95% Confidence Interval|Mean
701233|NCT00063635|Secondary|Change in Body Mass Index||baseline and 96 weeks|||kg/m-squared||95% Confidence Interval|Mean
701234|NCT00063635|Secondary|Number of Participants With Improvement in Ballooning Degradation Score|Ballooning is assessed on a scale of 0 to 2 with higher scores indicating more severe ballooning. This secondary outcome measure is the number of participants that experienced a decrease in ballooning score at 96 weeks compared to baseline, which indicates improvement in ballooning.|baseline and 96 weeks|Number of participants analyzed reflects the number of participants with baseline and 96 week liver biopsies.||participants|||Number
701235|NCT00063635|Secondary|Number of Participants With Improvement in Lobular Inflammation Score|Lobular inflammation is assessed on a scale of 0 to 3 with higher scores indicating more severe lobular inflammation. This secondary outcome measure is the number of participants that experienced a decrease in lobular inflammation score at 96 weeks compared to baseline, which indicates improvement in lobular inflammation.|baseline and 96 weeks|Number of participants analyzed reflects the number of participants with baseline and 96 week liver biopsies.||participants|||Number
701236|NCT00063635|Secondary|Number of Participants With Improvement in Steatosis Score|Steatosis is assessed on a scale of 0 to 3 with higher scores indicating more severe steatosis. This secondary outcome measure is the number of participants that experienced a decrease in steatosis score at 96 weeks compared to baseline, which indicates improvement in steatosis.|baseline and 96 weeks|Number of participants analyzed reflects the number of participants with baseline and 96 week liver biopsies.||participants|||Number
701237|NCT00063635|Secondary|Number of Participants With Improvement in Liver Fibrosis Score|Fibrosis is assessed on a scale of 0 to 4 with higher scores indicating more severe fibrosis. This secondary outcome measure is the number of participants that experienced a decrease in fibrosis score at 96 weeks compared to baseline, which indicates improvement in fibrosis.|baseline and 96 weeks|Number of participants analyzed reflects the number of participants with baseline and 96 week liver biopsies.||participants|||Number
701242|NCT00063934|Secondary|Clinical Imaging Responses|Evaluation target lesions (clinical response) by physical exam/ultrasound measurements of primary tumor and axillary lymph nodes after 3-6 courses: Complete Response: Disappearance of all target lesions; Partial Response: >30% decrease in sum longest diameter (LD) of target lesions, reference baseline sum LD; Progressive Disease: >20% increase in sum of LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of 1>new lesions; Stable Disease: Neither sufficient shrinkage for PR nor increase for PD, reference smallest sum LD since treatment started.|After 3 and 6 courses of 21 day treatments (up to 18 weeks)|||participants|||Number
701243|NCT00063934|Primary|Number of Participants With Pathologic Complete Response (pCR)|Pathologic complete responses (pCR), defined as no evidence of residual invasive tumor, including no residual tumor in the axillary lymph nodes, measured by microscopic evaluation of tissue specimen at time of definitive surgery (after 6 courses of neoadjuvant therapy). Neoadjuvant (preoperative) therapy administered on the first five days of every 3-week cycle. Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000]|At time of definitive surgery (after 6 courses of neoadjuvant therapy in 3 week cycles), approximately 18 weeks|Intention to treat eligible participants per protocol.||Participants|||Number
701244|NCT00063934|Primary|Participant Toxicity|Incidence of toxicity summarized using NCI Common Toxicity Criteria, version 3.0 every 3 weeks.|From baseline to study completion, every 3 weeks||||||
701245|NCT00063986|Secondary|Rate of Conversion to Open Operation After Neoadjuvant Therapy|Proportion of patients with neoadjuvant therapy required conversion to open operation is reported.|Assessed at surgery|35 eligible and treated patients with neoadjuvant therapy are included in this analysis.||Proportion of patients||95% Confidence Interval|Number
701246|NCT00063986|Secondary|30-day Peri-operative Mortality After Neoadjuvant Therapy|Proportion of patients with neoadjuvant therapy died within 30 days of operation is reported.|Assessed at 30 days after surgery|35 eligible and treated patients with neoadjuvant therapy are included in this analysis.||Proportion of patients||90% Confidence Interval|Number
701247|NCT00063986|Secondary|3-year Survival Rate|Patients are followed for survival for 3 years from registration. Overall survival is defined as the time from operation to death.|Assessed at 3 years|Eligible and treated patients are included in this analysis.||proportion of participants||95% Confidence Interval|Number
701248|NCT00063986|Secondary|Total Number of Lymph Nodes Dissected|The total number of lymph nodes dissected is reported to assess the effectiveness of lymph node dissection by MIE.|Assessed at surgery|Eligible and treated patients are included in this analysis. Out of 104 eligible and treated patients, the number of lymph nodes removed is missing for 1 patient, so the results are based on data from 103 patients.||Lymph nodes||Full Range|Median
701249|NCT00063986|Secondary|Overall Length of Hospital Stay|The number of days patients stayed in the hospital after surgery is reported.|Assessed after surgery until patients are out of hospital|Eligible and treated patients are included in this analysis. Out of 104 eligible and treated patients, duration of hospital stay is missing for 3 patients, so the results are based on data from 101 patients.||Days||Full Range|Median
701250|NCT00063986|Secondary|Duration of Intensive Care Stay|Number of post-operative days in intensive care is reported.|Assessed after surgery until patients are out of intensive care|Eligible and treated patients are included in this analysis. Out of 104 eligible and treated patients, duration of intensive care stay is missing for 3 patients, so the results are based on data from 101 patients.||Days||Full Range|Median
701251|NCT00063986|Secondary|Duration of Operating Time|The length of the operation (total of thoracic and abdominal components) is recorded.|Assessed at surgery|Eligible and treated patients are included in this analysis. Out of 104 eligible and treated patients, 10 patients' length of operation data were unavailable, so the results are based on data from 94 patients.||Minutes||Full Range|Median
701252|NCT00063986|Secondary|Rate of Conversion to Open Operation|Proportion of patients who required conversion to operation will be reported.|Assessed at surgery|Eligible and treated patients are included in this analysis.||Proportion of patients||95% Confidence Interval|Number
701253|NCT00063986|Primary|Peri-operative Mortality at 30 Days|The primary endpoint is 30-day peri-operative mortality rate. Proportion of patients died within 30 days of surgery will be reported.|Assessed at 30 days from surgery|Eligible and treated patients are included in this analysis.||proportion of participants||90% Confidence Interval|Number
701254|NCT00064025|Secondary|Change From Pre- to Post-treatment in Progestrogren Receptor (PR) Expression|Expression is based on an aggregate score based on immunohistochemistry. Staining intensity was scored 1, 2, or 3; and staining area was scored as a percentage (0-100%). The aggregate score is the product of staining intensity and area and ranges from 0 to 3.|During the hysterectomy , which is 21-24 days after administration of depo-provera|Eligible and Evaluable Patients (patients who had both an intake biopsy and hysterectomy)||Aggregate Score from Immunohistochemistr||Standard Error|Mean
701255|NCT00064025|Secondary|Change From Pre- to Post-treatment in Estrogren Receptor (ER) Expression|Expression is based on an aggregate score based on immunohistochemistry. Staining intensity was scored 1, 2, or 3; and staining area was scored as a percentage (0-100%). The aggregate score is the product of staining intensity and area and ranges from 0 to 3.|During the hysterectomy, which is 21-24 days after administration of depo-provera|Eligible and Evaluable Patients (patients who had both an intake biopsy and hysterectomy)||Aggregate Score from Immunohistochemistr||Standard Error|Mean
701256|NCT00064025|Primary|Histologic Response in Endometrial Adenocarcinomas of the Uterine Corpus That Are Progesterone Receptor Positive Compared With Those That Are Progesterone Receptor Negative|"To determine the presence of a histologic response, the slide from the initial sample was compared to the slide from the matching hysterectomy specimen. A complete histologic response was defined as the absence of identifiable adenocarcinoma in the hysterectomy specimen section. A partial histologic response was subjectively defined in advance of the study based on criteria slightly modified from Wheeler et al. (Am J Surg Pathol 2007;31:988-98) as the presence of a complex proliferation of glands that retain the architectural characteristics of adenocarcinoma, but with features of secretion, decreased nuclear stratification, or the presence of eosinophilic, squamous or mucinous metaplasia, when this was absent in the initial sample. A complete or partial histologic response was considered a histologic response in the analysis of data.
PR Positivity is based on aggregate score >0.2 (vs. <=0.2). Aggregate score based on product of staining intensity and area."|During the hysterectomy, which is 21-24 days after administration of depo-provera|Eligible and Evaluable Patients (patients who had both an intake biopsy and hysterectomy and had histologic response data)||percentage of participants|||Number
701257|NCT00064038|Primary|Progression-Free Survival|"Progression is defined as a > 25% increase from baseline in myeloma protein production or other signs of disease progression such as hypercalcemia, etc.
In patients with a confirmed Partial Remission, Remission, or Complete Remission, relapse is defined as the first occurrence of any of the following: 1) a myeloma protein increase by than 100% from the lowest level recorded on study, provided the absolute magnitude of this increase is at least 1g/dL for a serum monoclonal protein or at least 500 mg/24 hrs of urine M-protein; 2) a myeloma protein increase above the response criteria for Partial Remission, with the same requirements for the absolute magnitude of the protein increase; 3)reappearance of any myeloma peak that had disappeared while on protocol treatment, provided it meets the same requirements listed above; 4) increase in the size and number of lytic bone lesions recognized on radiographs."|From date of initial registration to date of progression/relapse of disease or death from any cause, whichever came first, up to 5 years|||percentage of participants||95% Confidence Interval|Number
701258|NCT00064038|Secondary|Toxicity|Compare the toxicity profile of these regimens, including thrombotic complications, in these patients, based on CTCAE v. 3.0.|From time of initiating study treatment until discontinuation of study treatment or of open-label REVLIMID + LOW DOSE DEX, whichever comes last, up to 5 years|All participants receiving at least one dose of induction therapy||Participants|||Number
701259|NCT00055237|Secondary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For the detailed list of adverse events, see the adverse event module.|70 months|"All adverse events regardless of attribution, over 202 cycles in 19 patients. Per protocol analysis of adverse events.
Cohort 1 and 2 are reported together."||Participants|||Count of Participants
701260|NCT00055237|Primary|Response Rate|Percentage of participants with a complete response (CR) + partial response (PR)per the Modified AIDS Clinical Trial Group Criteria (ACTG) for HIV-KS. PR is a 50% decrease in the number and/or size of previously existing lesions for 4 weeks; or complete flattening of at least 50% of all previously raised lesions lasting for at least 4 weeks; or a 50% decrease in the sum of the products of the largest perpendicular diameters of the marker lesions lasting for at least 4 weeks; CR is the absence of any detectable residual disease, including tumor associated edema, persisting for at least 4 weeks.|36 months|Cohort 2 is not reported here because response rate in HIV negative patients was a secondary outcome.||Percentage of participants||95% Confidence Interval|Mean
701261|NCT00055471|Secondary|Change in Urine Concentration of Type I Collagen-Cross Linked N Telopeptide (NTx)|Percentage change in urine concentration of Type I Collagen-Cross Linked N Telopeptide (NTx) (nmol BCE/mmol Creatinine) from baseline to Day 15 (14 doses of study treatment per patient – no dose was administered on Day 2). Percentage change = [(measure at Day 15 – measure at baseline)/measure at baseline]*100|Baseline to Day 15.|The analysis population includes only patients dosed with ZD4054||Percentage Change||Standard Deviation|Mean
701262|NCT00055471|Secondary|Change in Serum Concentration of C-Terminal Telopeptide of Type I Collagen (CTx)|Percentage change in serum concentration of C-Terminal Telopeptide of Type I Collagen (CTx) (ng/mL) from baseline to Day 15 (14 doses of study treatment per patient – no dose was administered on Day 2). Percentage change = [(measure at Day 15 – measure at baseline)/measure at baseline]*100|Baseline to Day 15.|The analysis population includes only patients dosed with ZD4054||Percentage Change||Standard Deviation|Mean
701263|NCT00055471|Secondary|Change in Serum Concentration of Procollagen Type I N Propeptide (PINP)|"Percentage change in serum concentration of Procollagen Type I N Propeptide (PINP) (ng/mL) from baseline to Day 15 (14 doses of study treatment per patient – no dose was administered on Day 2).
Percentage change = [(measure at Day 15 – measure at baseline)/measure at baseline]*100"|Baseline to Day 15.|The analysis population includes only patients dosed with ZD4054||Percentage Change||Standard Deviation|Mean
701264|NCT00055471|Secondary|Change in Serum Concentration of Bone Alkaline Phosphatase (ALP)|Percentage change in serum concentration of Bone Alkaline Phosphatase (ALP) (ng/mL) from baseline to Day 15 (14 doses of study treatment per patient – no dose was administered on Day 2). Percentage change = [(measure at Day 15 – measure at baseline)/measure at baseline]*100|Baseline to Day 15.|The analysis population includes only patients dosed with ZD4054||Percentage Change||Standard Deviation|Mean
701265|NCT00055471|Secondary|Change in Total Prostate Specific Antigen (PSA)|"Percentage change in total Prostate Specific Antigen (PSA) (ng/mL) from baseline to Day 15 (14 doses of study treatment per patient – no dose was administered on Day 2).
Percentage change = [(measure at Day 15 – measure at baseline)/measure at baseline]*100"|Baseline to Day 15.|The analysis population includes only patients dosed with ZD4054||Percentage Change||Standard Deviation|Mean
701266|NCT00055471|Secondary|Total Prostate Specific Antigen (PSA) Concentration|Total Prostate Specific Antigen (PSA) concentration at Day 15 (14 doses of study treatment per patient – no dose was administered on Day 2).|Baseline to Day 15.|All dosed patients.||ng/ml||Full Range|Geometric Mean
701267|NCT00055471|Primary|Dose Limiting Toxicities (DLTs)|"DLT is defined as experiencing Common Toxicity Criteria (CTC) grade 3 or 4 headache with onset within 24 h of receiving ZD4054, CTC grade 2 rhinitis leading to the withdrawal of the subject, or other CTC grade 3 or 4 toxicity that was considered to be related to ZD4054 treatment.
The numbers of patients with a DLT are reported."|Baseline to Day 29.|||Participants|||Number
701268|NCT00055497|Secondary|Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Scores - LOCF|"IBDQ is a validated disease−specific instrument that assesses the impact of IBD on patient quality of life during a 2−week recall period. It has 32 questions about bowel function and related symptoms, and their social and emotional impact. For each question, participants selected 1 of 7 responses, where 1=poor quality of life (e.g., feeling of fatigue all of the time) and 7=good quality on the item (e.g., feeling of fatigue none of the time). IBDQ scores range from 32 to 224. Higher scores indicate better quality of life, and increases in IBDQ indicate improved overall quality of life."|Change from Baseline of lead-in study to Week 24 and Week 56|Participants randomized to DB treatment who received at least one injection of blinded study drug were included in assigned treatment group. OL adalimumab group was all participants assigned to the OL treatment who continued past Week 4. LOCF was used for missing data. 4 participants in OL group did not have IBDQ data at Baseline of lead-in study.||Scores on a scale||95% Confidence Interval|Mean
701306|NCT00056407|Secondary|Number of Participants With at Least One Urinary Tract Infection (UTI)|A participant was considered to have a UTI if the investigator noted that the participant had UTI symptoms and had been prescribed antibiotics. Participants were asked to report any events of UTI during the study.|Years 1-2, Years 3-4, and Overall (Years 1-4)|Efficacy Population||participants|||Number
701269|NCT00055497|Secondary|Number of Participants Achieving CR-70 - LOCF|A CR-70 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 70 or more points, indicating a significant improvement in disease severity. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.|From Baseline of lead-in study to Week 24 and Week 56|Subjects randomized to DB treatment who received at least one injection of blinded study drug were included in assigned treatment group. Subjects in the OL adalimumab group were all subjects who were assigned to the OL treatment and continued past Week 4. LOCF imputation was used for missing data.||Participants|||Number
701270|NCT00055497|Secondary|Number of Participants Achieving CR-100 - LOCF|A CR-100 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 100 or more points, indicating significant improvement in disease severity. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.|From Baseline of lead-in study to Week 24 and Week 56|Subjects randomized to DB treatment who received at least one injection of blinded study drug were included in assigned treatment group. Subjects in the OL adalimumab group were all subjects who were assigned to the OL treatment and continued past Week 4. LOCF was used for missing data.||Participants|||Number
701271|NCT00055497|Secondary|Number of OL Participants Achieving Clinical Remission at Week 56 - LOCF|Clinical remission is defined as CDAI score <150. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.|Week 56|||Participants|||Number
701272|NCT00055497|Secondary|Number of Participants Achieving Clinical Remission at Week 24 - LOCF|Clinical remission is defined as CDAI score <150. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.|Week 24|Participants randomized to DB treatment who received at least one injection of blinded study drug were included in assigned treatment group. Participants in the OL adalimumab group were all participants who were assigned to the OL treatment and continued past Week 4. Last observation carried forward (LOCF) was used for missing data.||Participants|||Number
701273|NCT00055497|Secondary|Number of Participants Achieving Clinical Response 70 (CR-70)- NRI|A CR-70 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 70 or more points, indicating a significant improvement in disease severity. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.|From Baseline of lead-in study to Week 24 and to Week 56|Participants randomized to DB treatment who received at least one injection of blinded study drug were included in assigned treatment group. Participants in the OL adalimumab group were all participants who were assigned to the OL treatment and continued past Week 4. Nonresponder imputation (NRI) (CR-70 not achieved) was used for missing data.||Participants|||Number
701274|NCT00055497|Secondary|Number of Participants Achieving Clinical Response 100 (CR-100) - NRI|A CR-100 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 100 or more points, indicating significant improvement in disease severity. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.|From Baseline of lead-in study to Week 24 and Week 56|Participants randomized to DB treatment who received at least one injection of blinded study drug were included in assigned treatment group. Participants in the OL adalimumab group were all participants who were assigned to the OL treatment and continued past Week 4. Nonresponder imputation (NRI) (CR-100 not achieved) was used for missing data.||Participants|||Number
701275|NCT00055497|Primary|Number of Randomized Participants Achieving Clinical Remission at Week 56 - Last Observation Carried Forward (LOCF)|Clinical remission is defined as CDAI score <150. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.|Week 56|Participants randomized to DB treatment who received at least one injection of blinded study drug were included in assigned treatment group. Last observation carried forward was used for missing data.||Participants|||Number
701276|NCT00055497|Primary|Number of Randomized Participants Achieving Clinical Remission at Week 56 - Non-Responder Imputation (NRI)|Clinical remission is defined as CDAI score <150. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.|Week 56|Participants randomized to DB treatment who received at least one injection of blinded study drug were included in assigned treatment group. Nonresponder imputation (NRI) (clinical remission not achieved) was used for missing data.||Participants|||Number
701277|NCT00055497|Secondary|Number of OL Participants Achieving Clinical Remission at Week 56 - NRI|Clinical remission is defined as CDAI score <150. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.|Week 56|Participants in the OL adalimumab group were all participants who were assigned to the OL treatment and continued past Week 4. Nonresponder imputation (NRI) (CR-100 not achieved) was used for missing data.||Participants|||Number
701307|NCT00056407|Secondary|Number of Participants With at Least One Event of Acute Urinary Retention (AUR)|A participant was considered to have AUR when he reported being unable to urinate and required catherization. Participants were asked to report any events of AUR during the study.|Years 1-2 and Overall (Years 1-4)|Efficacy Population||participants|||Number
701278|NCT00055497|Secondary|Number of Participants Achieving Clinical Remission at Week 24 - NRI|Clinical remission is defined as CDAI score <150. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.|Week 24|Participants randomized to DB treatment who received at least one injection of blinded study drug were included in assigned treatment group. Participants in the OL adalimumab group were all participants who were assigned to the OL treatment and continued past Week 4. Nonresponder imputation (NRI) (CR-100 not achieved) was used for missing data.||Participants|||Number
701279|NCT00055601|Secondary|Bladder-intact Survival Rate (5 Years)|Bladder-intact survival was measured from the date of randomization to occurrence of cystectomy or death. Five-year rates were estimated using the Kaplan-Meier method.|From the date of randomization to five years.|All eligible patients who started study treatment||percentage of participants||95% Confidence Interval|Number
701280|NCT00055601|Secondary|Complete Response After Induction|Complete response requires the absence of any tumor in the tumor-site biopsy specimen or elsewhere and a bimanual exam that does not indicate the presence of a tumor mass.|From randomization to eight weeks|All eligible patients who started study treatment||percentage of participants||95% Confidence Interval|Number
701281|NCT00055601|Primary|Treatment Completion Rate|Radiation therapy and chemotherapy per protocol or within acceptable variation guidelines based on central review. The study was designed for a two-sided binomial test with 87% power and a significance level of 0.05 with a null hypothesis of a 70% completion rate against the alternative 90% completion rate. For each arm, more than 34 out of 43 evaluable patients completing the treatment, would indicate to reject the null hypothesis for a better treatment completion rate. Fewer than 24 out 43 evaluable patients completing the treatment would indicate to reject the null hypothesis for a worse treatment completion rate. Otherwise, the conclusion would be that there is not enough evidence to reject the null hypothesis of a 70% completion rate in either direction.|From randomization to 11 weeks|All eligible patients who started study treatment.||percentage of participants||95% Confidence Interval|Number
701282|NCT00055692|Other Pre-specified|Disease Stability||At 6 months||||||
701283|NCT00055692|Primary|To Collect Information on Hepatic Function and Hepatitis Viral Activity in Cirrhosis and Upon Potential Alterations in the Setting of VEGF-inhibition||During and after treatment|No data was collected by the principal investigator for this outcome|||||
701284|NCT00055692|Primary|Assessment on Circulating Levels of VEGF Which Also Contribute to HCC Pathogenesis and on Potential Alterations of These Levels in the Setting of VEGF-inhibition||During treatment|Six of eight patients were analyzed after 8 weeks of bevacizumab therapy||pg/mL||Standard Deviation|Mean
701285|NCT00055692|Primary|Mean Arterial Enhancement, Per Lesion, as Determined by Dynamic Gadolinium-enhanced Magnetic Resonance Imaging (MRI), Before and Following Bevacizumab Therapy.||Baseline and 8 weeks after bevacizumab therapy|Eight consecutive patients enrolled at one site were evaluated before and at 8 weeks after bevacizumab therapy with DCE-MRI.||relative MR units||Standard Deviation|Mean
701286|NCT00055692|Primary|Disease Response|MRI scan is required at weeks 8, 16 and then every 12 weeks until disease progression. Per Response Evaluation Criteria in Solid Tumors (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|MRI is required at weeks 8, 16 and then every 12 weeks until disease progression|||participants||95% Confidence Interval|Number
701287|NCT00055692|Primary|Progression-free Survival||At 6 months|||percentage of participants||95% Confidence Interval|Number
701292|NCT00056316|Secondary|Secondary Outcome: Negative Affect Scale (Watson, Clark & Tellegen, 1988)|"10 item self-report assessment of negative affects. Participants rate items on a scale from 1 to 5, based on the strength of emotion where 1 = very slightly or not at all, and 5 = extremely. The total continuous score may range from 10 to 50, with higher values indicative of stronger negative emotion."|Post-intervention, assessed 4-14 days after final intervention session.|All participants who were randomized into the study were included in the analyses (i.e., Intention to treat). Missing values were replaced with the Last Observation Carried Forward (LOCF) imputation method.||Points on a scale||Standard Deviation|Mean
701293|NCT00056316|Primary|Primary Outcome: Beck Depression Inventory II (Beck, Steer & Brown, 1996)|21-item self-report instrument to assess severity of symptoms of depression. There is a four-point scale for each item ranging from 0 to 3. The total continuous score can range from 0 to 63 points, with higher scores reflective of greater severity.|Post-intervention, assessed 4-14 days after final intervention session.|All participants who were randomized into the study were included in the analyses (i.e., Intention to treat). Missing values were replaced with the Last Observation Carried Forward (LOCF) imputation method.||Points on a scale||Standard Deviation|Mean
701294|NCT00056316|Secondary|Negative Affect Schedule (Watson, Clark & Tellegen, 1988)|"10 item self-report assessment of negative affects. Participants rate items on a scale from 1 to 5, based on the strength of emotion where 1 = very slightly or not at all, and 5 = extremely. The total continuous score may range from 10 to 50, with higher values indicative of stronger negative emotion."|Pre-intervention intake assessment, conducted 7-14 days prior to start of intervention|All participants who were randomized into the study were included in the analyses (i.e., Intention to treat). Missing values were replaced with the Last Observation Carried Forward (LOCF) imputation method.||Points on a scale||Standard Deviation|Mean
701295|NCT00056316|Primary|Beck Depression Inventory II (Beck, Steer & Brown, 1996)|21-item self-report instrument to assess severity of symptoms of depression. There is a four-point scale for each item ranging from 0 to 3. The total continuous score can range from 0 to 63 points, with higher scores reflective of greater severity.|Pre-intervention intake assessment, conducted 7-14 days prior to start of intervention|All randomized participants||Points on a scale||Standard Deviation|Mean
701296|NCT00056407|Secondary|Mean Change From Baseline in Testosterone at Month 48|Testosterone, a male sex hormone, was measured by taking blood samples at screening and yearly thereafter.|Baseline and Month 48|Efficacy Population (LOCF). The numbers presented are less than the overall population, as data were not available for all participants.||percent change||Standard Deviation|Mean
701297|NCT00056407|Secondary|Number of Participants With the Indicated Serum Dihydrotestosterone (DHT) Concentration at Month 48|Number of participants whose DHT, the active form of the male sex hormone testosterone, was less than 0.555 nanomoles/liter and below the level of detection at Month 48 was measured. It was measured by taking blood samples at screening and yearly thereafter.|Month 48|Efficacy Population (LOCF). The number analyzed is smaller than the total number in the population due to missing values.||participants|||Number
701298|NCT00056407|Secondary|Adjusted Mean Change From Baseline in the Problem Assessment Scale of the Sexual Function Index (PASSFI) at Month 48|The PASSFI is a 3-item questionnaire that measures sexual function. Responses range from 0 (big problem) to 4 (no problem), with a total score of 12. A higher score indicates fewer problems with sexual functioning. Participants completed the questionnaire at Baseline and then yearly . Participants whose language did not have a validated translation of the questionnaire did not participate. Estimates are based on the adjusted means from the general linear model: change from baseline = baseline value and cluster and treatment.|Baseline and Month 48|Efficacy Population (LOCF). The number analyzed is smaller than the total number in the population due to missing values.||points on a scale||Standard Error|Mean
701299|NCT00056407|Secondary|Adjusted Mean Change From Baseline in Quality of Life Question 8 (QOL Q8) at Month 48|The QOL Q8 is the last question of the IPSS Questionnaire. It is a question about the participant's quality of life as it relates to prostate symptoms. Responses range from 0 (most positive) to 6 (most negative). A higher score indicates worse quality of life. Participants completed the questionnaire at Screening, Baseline, and at each 6-month visit. Estimates are based on the adjusted means from the general linear model: change from baseline = baseline value and cluster and treatment.|Baseline and Month 48|Efficacy Population (LOCF). The number analyzed is smaller than the total number in the population due to missing values.||points on a scale||Standard Error|Mean
701300|NCT00056407|Secondary|Adjusted Mean Change From Baseline in the National Institutes of Health Chronic Prostatitis Symptom Index (NIH CPSI) at Month 48|The NIH CSPI is a 9-item questionnaire that measures chronic prostatitis symptoms. The total score ranges from 0 to 43. A higher score indicates greater negative impact of prostatitis. Participants completed the questionnaire at Baseline and at each 6-month visit. Participants whose language did not have a validated translation of the questionnaire did not participate. Estimates are based on the adjusted means from the general linear model: change from Baseline = Baseline Value and Cluster and Treatment.|Baseline and Month 48|Efficacy Population (LOCF). The numbers presented are less than the overall population, as data were not available for all participants.||points on a scale||Standard Error|Mean
701301|NCT00056407|Secondary|Adjusted Mean Change From Baseline in The Medical Outcomes Study Sleep Problems Index 6-item Standard Version (MOS Sleep-6S) at Month 48|The MOS Sleep-6S is a 6-item questionnaire measuring quality of sleep. Scores range from 1 (all of the time) to 6 (none of the time) and are converted to a 1-100 scale and then averaged; a higher score indicates greater negative impact, which indicates more sleep disturbance. Participants completed the questionnaire at Baseline and at each 6-month visit. Participants whose language did not have a validated translation of the questionnaire did not participate. Estimates are based on the adjusted means from the general linear model: change from baseline=baseline value and cluster and treatment.|Baseline and Month 48|Efficacy Population (LOCF). The numbers presented are less than the overall population, as data were not available for all participants.||points on a scale||Standard Error|Mean
701302|NCT00056407|Secondary|Adjusted Mean Change From Baseline in the Benign Prostatic Hypertrophy (BPH) Impact Index (BII) at Month 48|The BII is a 4-item questionnaire that rates the level of BPH-related physical discomfort, worry, and interference with normal activities the participant has experienced. The total BII score ranges from 1 (no impact on symptoms) to 13 (major impact on symptoms). Participants completed the questionnaire at Baseline and at each 6-month visit. Participants whose language did not have a validated translation of the questionnaire did not participate. Estimates are based on the adjusted means from the general linear model:change from baseline = baseline value and cluster and treatment.|Baseline and Month 48|Efficacy Population (LOCF). The numbers presented are less than the overall population, as data were not available for all participants.||points on a scale||Standard Error|Mean
701303|NCT00056407|Secondary|Overall Survival|Overall survival is assessed as the number of deaths reported throughout the study.|From time informed consent is signed to 4-month Safety Follow-Up period|Efficacy Population||number of deaths|||Number
701304|NCT00056407|Secondary|Number of Participants With Post-biopsy Macroscopic Hematospermia|Participants reported events of macroscopic hematospermia (visible blood in semen) throughout the study.|Baseline through Year 4|Efficacy Population||participants|||Number
701309|NCT00056407|Secondary|Adjusted Mean Change From Baseline in Maximum Urinary Flow (Qmax) at Months 12, 24, 36, and 48|Maximum urinary flow was measured at selected sites using a Dantec Uroflow meter with a Thompson filter. Change from baseline was calculated as Month 12, 24, 36, and 48 values minus the baseline value. Estimates are based on the adjusted means from the general linear model: change from baseline = baseline Qmax and treatment. This measurement was performed at selected centers.|Baseline and Months 12, 24, 36, and 48|Efficacy Population (LOCF). The number analyzed is smaller than the total number in the population due to missing values.||milliliters/second||Standard Error|Mean
701310|NCT00056407|Secondary|Adjusted Mean Percentage Change From Baseline in Prostate Volume at Months 24 and 48|Prostate volume was measured by transrectal ultrasound (TRUS) when biopsies were performed at Year 2 and Year 4. The investigator calculated the prostate volume using three prostate measurements (anteroposterior, cephalocaudal, and transverse diameters). Estimates are based on the adjusted means from the general linear model: log(Post-Baseline/Baseline value) = treatment and cluster and log (baseline value).|Baseline, Month 24, and Month 48|Efficacy Population (LOCF). The number analyzed is smaller than the total number in the population due to missing values.||percent change||Standard Error|Mean
701311|NCT00056407|Secondary|Adjusted Mean Change From Baseline in the International Prostate Symptom Score (IPSS) at Month 48|The IPSS is a 7-item questionnaire that measures urinary symptoms. It measures the level of urinary symptoms (including incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia) reported as the total IPSS score. Each of the 7 questions has a 6-point response scale (0=none/not at all to 5=almost always) with a total score that can range from 0-35: mild (0-7), moderate (8-19), or severe (20-35). Estimates are based on adjusted means from the general linear model: change from baseline = baseline value and cluster and treatment.|Baseline to Year 4 (Month 48)|Efficacy Population, last observation carried forward (LOCF). In the LOCF approach, missing values at post-baseline assessments are replaced with the participant's previous non-missing post-baseline assessment. The number analyzed is smaller than the total number in the population due to missing values.||points on a scale||Standard Error|Mean
701312|NCT00056407|Secondary|Number of Participants Undergoing Intervention (Surgical and Non-surgical) for Prostate Cancer Treatment|The number of participants who received treatment for prostate cancer was measured. Prostate cancer interventions included surgical interventions (e.g., prostatectomy, adenomectomy, transurethral resection) and non-surgical interventions (e.g., chemotherapy, hormone therapy, radiation therapy).|Baseline to Year 4|Efficacy Population||participants|||Number
701313|NCT00056407|Secondary|Treatment Alteration Score|The treatment alteration score is a measure of the cellular changes due to treatment (effect of male hormone withdrawal) on the nucleus and cytoplasm of the prostate cancer cell. The treatment alteration score is the sum of two scores (the nuclear alteration score and the cytoplasmic architectural score), each ranging from 0 to 3, with 0 indicating no change and 3 indicating severe changes.|Baseline to Year 4|Biopsied Population. Only needle biopsies are included (surgeries are excluded). The number analyzed is smaller than the total number in the population due to missing values.||points on a scale||Standard Deviation|Mean
701314|NCT00056407|Secondary|Number of Cancer-positive Cores|The average number of prostate biopsy samples (cores) determined to be cancerous by the pathologist was measured. Normally, 10 cores were taken per biopsy for each participant.|Baseline to Year 4|Prostate Cancer Population. Only needle biopsies are included (surgeries are excluded). The number analyzed is smaller than the total number in the population due to missing values.||number of cores||Standard Deviation|Mean
701315|NCT00056407|Secondary|Percentage of Core Involved at Diagnosis|The average amount of cancer seen by the pathologist in the prostate tissue samples taken during the biopsy was measured. A core is a prostate biopsy sample.|Baseline to Year 4|Prostate Cancer Population: all participants in the Efficacy Population who received a post-baseline diagnosis of prostate cancer by the central pathology laboratory. Only needle biopsies are included (surgeries are excluded). The number analyzed is smaller than the total number in the population due to missing values.||percentage of core||Standard Deviation|Mean
701316|NCT00056407|Secondary|Volume of HGPIN at Biopsy|The amount of prostate biopsy tissue with HGPIN was measured.|Baseline to Year 4|Biopsied Population. Only needle biopsies are included (surgeries are excluded). The number analyzed is smaller than the total number in the population due to missing values.||cc*10^-3 (microliter)||Standard Deviation|Mean
701317|NCT00056407|Secondary|Number of Participants With HGPIN, ASAP, and Prostate Cancer at Biopsy|"The occurrence and quantity of high-grade prostatic intraepithelial neoplasia (HGPIN) and atypical small acinar proliferation (ASAP) at biopsy were measured. HGPIN and ASAP are considered precancerous conditions. A participant diagnosed with prostate cancer only (i.e., no HGPIN or ASAP) was counted in both the first category (HGPIN or prostate cancer diagnosis) and again in the last category (HGPIN, ASAP, or prostate cancer diagnosis)."|Baseline to Year 4|Biopsied Population: the number analyzed is the total number in the population||participants|||Number
701318|NCT00056407|Secondary|Number of Participants With the Indicated Gleason Score at Diagnosis|Gleason score was determined by examining prostate biopsies and surgical samples. The Gleason scoring system sums the two most common Gleason grade patterns in order to predict the likelihood of a participant doing well or badly with their cancer. Gleason grades range from 1 (normal) to 5 (advanced cancer). The lowest Gleason score is 2 (1+1), and the highest Gleason score is 10 (5+5). A Gleason score of 2-6 is a low-grade cancer; a Gleason score of 7-10 is high-grade cancer. The most severe high-grade cancers are the subset of Gleason scores 8-10.|Baseline to Year 4|Biopsied Population: all randomized participants with a negative entry biopsy who received at least 1 dose of study treatment and who had at least 1 biopsy reviewed by the central pathology lab. Only needle biopsies are included (surgeries are excluded). The number analyzed is smaller than the total number in the population due to missing values.||participants|||Number
701333|NCT00056862|Primary|Virological Response Category (Per Protocol)|Virological response category. Sustained virological response (SVR) is defined as negative serum HCV RNA at least 6 months after the end of treatment. Non-response is defined as serum HCV RNA positivity on week 12 of treatment. Breakthrough/relapse is defined as HCV RNA becoming negative and subsequently positive on treatment or after treatment is stopped.|6 months after therapy|Per protocol||participants|||Number
701334|NCT00056862|Secondary|First Phase Decline in Logarithm of HCV RNA Level|The 1st phase decline is defined as the log difference between baseline HCV RNA level and the level on day 2 of treatment (see Neumann et al, Science, 1998).|2 days|||logIU/mL||Standard Deviation|Mean
701319|NCT00056407|Primary|Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Restricted Crude Rate Approach)|Study biopsies consisted of 10 biopsy samples (cores) in a pre-defined pattern. Biopsies were read at the central pathology laboratory (which processed the majority, 94%, of biopsies). Biopsy cases that were positive for prostate cancer or precancerous lesions (HGPIN or ASAP) and prostate surgeries were reviewed by the lead pathologist. Participants included in the risk set at Years 1-2, Years 3-4, and Overall (Years 1-4) were those who had a biopsy during the specified time period.|Years 1-2, Years 3-4, and Overall (Years 1-4)|Efficacy Population, restricted crude rate: the number of prostate cancer events is based on the the number of participants who had at least one biopsy during the time period. Ns at Years 1-2 and Years 3-4 are the number who had a biopsy in those time periods; the overall n is the number of participants who had 1 or more biopsy during Years 1-4.||participants|||Number
701320|NCT00056407|Primary|Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Modified Crude Rate Approach)|Study biopsies (biop.) consisted of 10 biop. samples (cores) in a pre-defined pattern and were read at the central pathology laboratory. Biop. cases that were positive for prostate cancer or precancerous lesions (HGPIN or ASAP) and prostate surgeries were reviewed by the lead pathologist. Participants included in the risk sets at Years 1-2 and Years 3-4 included those with a positive biop. at Years 1-2 or a biop. after Months 18-24, and those with a positive biop. at Years 3-4 or a biop. after Month 42, respectively. Overall included participants with a positive biop. or biop. after Month 42.|Years 1-2, Years 3-4, and Overall (Years 1-4)|Efficacy Population, modified crude rate: participants who either were diagnosed with prostate cancer during the study or had an end of time period biopsy. N for each time period is the number who either had at least 1 biopsy in the final 6 months of the time period or had a positive biopsy anytime during the time period.||participants|||Number
701321|NCT00056407|Primary|Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Crude Rate Approach)|Study biopsies consisted of 10 biopsy samples (cores) in a pre-defined pattern. Biopsies were read at the central pathology laboratory (CPL, which processed the majority, 94%, of biopsies). Biopsy cases that were positive for prostate cancer or precancerous lesions (high-grade prostatic intraepithelial neoplasia[HGPIN] or typical small acinar proliferation [ASAP]) and prostate surgeries were reviewed by the lead pathologist.|Years 1-2, Years 3-4, and Overall (Years 1-4)|Efficacy Population: all randomized participants with a negative entry biopsy, as determined by the CPL, who received at least 1 dose of study drug. The crude rate approach included all participants at risk at the beginning of each time period .||participants|||Number
701322|NCT00056472|Other Pre-specified|Mean Score Hamilton Depression Rating Scale (Ham-D) Over the Course of the Trial From Week to Week.|The Ham-D measures depression severity. Scores on Ham-D range from 0 to 52 with higher scores indicating more severe depression.|Weeks 1 to 12|||Scores on Ham-D||Standard Error|Mean
701323|NCT00056472|Secondary|Scores on CGI-S Compared to Baseline Over the Course of the Trial|A measure of overall symptom severity, the Clinical Global Impressions, Severity of Illness Scale (CGI-S). It is a seven point scale with a one indicating not at all ill, and seven indicating the most extremely ill. This rating was done each week after baseline by the PI at each site after visiting with the patient.|Weeks 1 to 12|||units on CGI scale||Standard Error|Mean
701324|NCT00056472|Primary|Remission of Depression Hamilton Depression Scale (Ham-D) and Psychosis Schedule for Affective Disorders in Schizophrenia - Delusional Item (SADS) During the Course of the Trial|"Remission was defined as scores on Ham-D of less than 10 at two consecutive assessments and the absence of delusions (measured as SADS delusional item scores of 1) at the second assessment of the two-assessment remission of depression interval.
Scores on Ham-D range from 0 to 52 with higher scores indicating more severe depression. Scores on SADS range from 1 to 7 with higher scores indicating the delusions(s) more adversely effect the subject's behavior."|Weeks 1 to 12|||participants|||Number
701325|NCT00056498|Secondary|Neuropsychological Testing||Measured at baseline and Week 16||08/2017||||
701326|NCT00056498|Primary|Brief Psychiatric Rating Scale (BPRS)|Scale assesses psychotic symptoms on a 20-item scale. The severity of each item is rated on a continuous scale from 1-7, with 1 being the least severe and 7 being most severe.|Measured at baseline and every 2 weeks for 16 weeks|64 participants began study medication and were used in the Intent to Treat(ITT) analyses (risperidone: 30; placebo:34). 53 subjects were used in the completer analyses (risperidone: 25; placebo: 28) BPRS items 4, 11, 12, and 15 (positive symptoms of schizophrenia), potentially ranging from 4 to 28 were used in the analyses.||Units on Scale||Standard Deviation|Mean
701327|NCT00056550|Secondary|Local Assessment of Thromboembolism by Physical Examination.|The investigators evaluated patients for any clinical signs of thromboembolism by physical examination.|30 days after last dose|14 patients were included in the trial and treated with rhAT.||Participants in study|||Number
701328|NCT00056550|Primary|Incidence of Thromboembolic Events Acute Deep Venous Thrombosis (DVT) and/or Thromboembolic Events Other Than Acute Deep Vein Thrombosis (DVT).|Observation for clinical signs and symptoms of thromboembolic events are evaluated for acute deep vein thrombosis (DVT) using duplex ultrasonography and/or other imaging tests to confirm clinical signs/symptoms. Duplex ultrasonography was performed at baseline, last day of dosing and day 7 (+ or -1 day).|Baseline, last day of dosing and day 7 (+ or - 1 day)|14 patients who received at least 1 dose of rhAT were included in the Safety population. During the central review of the duplex ultrasound, 1 delivery patient was diagnosed with a DVT at baseline, and was not evaluable for efficacy, the patient was excluded from the PP population.||participants|||Number
701329|NCT00056563|Secondary|The Change of Scores on the UPDRS for Blinded Assessed Motor Function 'Off' Medication and 'on' Stimulation|Unified Parkinson’s Disease Rating Scale (UPDRS Part III) measured while the patient is off medications and on stimulation at follow-up visits post surgery. UPDRS Part III has 14 items assessing motor skills including facial expression and speech, tremors, rigidity, posture, gait, and bradykinesia. Left and right sides (arms, legs, and hands) are assessed separately for seven of the functions. A summary score ranging from 0 to 108 is generated by adding the 14 specific motor function responses. The motor function (UPDRS part III) assessments are done by turning on the stimulation with and without taking PD medications (on/off) at each in-person visit. The higher score indicates that the condition is worse.|at six months|||units||95% Confidence Interval|Mean
701330|NCT00056563|Primary|The Difference of Time Spent in the 'on' State Without Troublesome Dyskinesia Based on Patient Motor Diaries as Compared to the Baseline.||at six months|||Hours per day||95% Confidence Interval|Mean
701357|NCT00057785|Secondary|Chemotherapy Compliance||From start of treatment to end of treatment||||||
701335|NCT00056862|Primary|Virological Response (Intention to Treat)|Virological response category. Sustained virological response (SVR) is defined as negative serum HCV RNA at least 6 months after the end of treatment. Non-response is defined as serum HCV RNA positivity on week 12 of treatment. Breakthrough/relapse is defined as HCV RNA becoming negative and subsequently positive on treatment or after treatment is stopped.|6 months after stopping therapy|Intention-to-treat||participants|||Number
701336|NCT00057330|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed included medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in a subject’s offspring.|Throughout the study (From Month 0 up to Month 20)|The Intention To Treat cohort for the analysis of safety included all vaccinated subject for whom safety data were available.||Subjects|||Number
701337|NCT00057330|Secondary|Number of Subjects With New Onset Chronic Diseases (NOCDs), Medically Significant Conditions (MSCs) and Serious Adverse Events (SAEs)|NOCDs included adverse events (AEs) as autoimmune disorders, asthma, type I diabetes, allergies. MSCs included AEs prompting emergency room or physician visits unrelated to common diseases or routine visits for physical examination or vaccination, or SAEs unrelated to common diseases. SAEs included medical occurrences either life-threatening, requiring hospitalization, or resulting in death, disability/incapacity or congenital anomaly/birth defect in a subject’s offspring. Common diseases included upper respiratory infections (URIs), sinusitis, pharyngitis, gastroenteritis, urinary tract infection, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury. The following were not reported if not considered as SAEs and occurring more than 30 days post vaccination: URIs, sinusitis, pharyngitis, gastroenteritis, injury, or visits for routine physical examination or vaccination. AEs are described, using Medical Dictionary for Regulatory Activities’ preferred terms.|Throughout the study (From Month 0 up to Month 20)|The Intention To Treat cohort for the analysis of safety included all vaccinated subject for whom safety data were available.||Subjects|||Number
701338|NCT00057330|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited AEs have been tabulated for a 31-day period. An unsolicited AE was any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within 31 days after vaccination|The Intention To Treat cohort for the analysis of safety included all vaccinated subject for whom safety data were available.||Subjects|||Number
701339|NCT00057330|Secondary|Number of Subjects Reporting Grade 3 and Related Solicited General Symptoms|"Solicited general symptoms assessed were fatigue, headache, malaise and fever (oral/axillary/tympanic).
Grade 3 headache, fatigue, malaise = symptom that prevented normal activities.
Grade 3 fever = temperature above 39.0 degrees Celsius.
Related = symptom assessed by the investigator as causally related to the vaccination"|Within 7 days (Days 0-6) after vaccination|The Intention To Treat cohort for the analysis of safety included all vaccinated subject for whom safety data were available.||Subjects|||Number
701340|NCT00057330|Secondary|Number of Subjects Reporting Grade 3 Solicited Local Symptoms|"Solicited local symptoms assessed were pain, redness and swelling.
Grade 3 pain = pain that prevented normal activities.
Grade 3 redness/swelling = redness/swelling above 30 mm and persisting for more than 24 hours"|Within 7 days (Days 0-6) after vaccination|The Intention To Treat cohort for the analysis of safety included all vaccinated subject for whom safety data were available.||Subjects|||Number
701341|NCT00057330|Secondary|Number of Subjects Reporting Solicited Local and General Symptoms|"Solicited local symptoms assessed were pain, redness and swelling.
Solicited general symptoms assessed were fatigue, headache, malaise and fever (defined as oral/axillary/tympanic temperature equal to or above 37.5 degrees Celsius)."|Within 7 days (Days 0-6) after vaccination|The Intention To Treat cohort for the analysis of safety included all vaccinated subject for whom safety data were available.||Subjects|||Number
701342|NCT00057330|Secondary|Titers for Anti-herpes Simplex Virus (Anti-HSV) Neutralizing Antibodies.|Titers for Anti-HSV neutralizing antibodies are presented as Geometric Mean Titers (GMTs), and are expressed in Estimated Doses (ED), that is, the reciprocal of the dilution necessary to achieve neutralization. Antibody titers below the lowest level of quantification were not calculated .|At Months 0, 2, 6, 7, 12, 16 and 20|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects (meeting eligibility criteria, complying with protocol-defined procedures and not meeting either the infection or disease criteria on or prior to Month 7) for whom data concerning immunogenicity outcome measures were available.||ED||95% Confidence Interval|Geometric Mean
701343|NCT00057330|Secondary|Concentrations for Anti-glycoprotein D (Anti-gD) Antibodies.|Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA units per milliliter (EU/mL). The seroprotection cut-off of the assay was 40 EU/mL|At Months 0, 2, 6, 7, 12, 16 and 20|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects (meeting eligibility criteria, complying with protocol-defined procedures and not meeting either the infection or disease criteria on or prior to Month 7) for whom data concerning immunogenicity outcome measures were available.||EU/mL||95% Confidence Interval|Geometric Mean
701344|NCT00057330|Secondary|Number of Subjects With Newly Acquired Herpes Simplex Virus (HSV)-2 Infection Confirmed by Either Virus Culture or HSV-2 Seroconversion|The number of subjects with newly acquired HSV-2 infection confirmed by either virus culture or HSV-2 seroconversion was tabulated. Seroconversion to HSV-1 and/or HSV-2 was defined as a positive HSV-1 and/or HSV-2 Western blot in a subject with a previously negative Western blot result for the corresponding HSV type.|Between Months 7 and 20|The Per Protocol cohort for analysis of efficacy (Months 7-20) included all subjects who met inclusion/exclusion criteria, did not meet infection/disease, did not meet censoring criteria, had at least 1 efficacy assessment, received 3 doses of the vaccine within the permitted time interval, with known vaccine administration site and route.||Subjects|||Number
701358|NCT00057785|Secondary|Other Acute and Late Toxicities||From start of treatment to last follow-up||||||
701359|NCT00057785|Secondary|Whole Mouth Saliva Output Relative to Pretreatment Measurements||From start of treatment to 1 year||||||
701360|NCT00057785|Secondary|Rate of Locoregional Control at 2 Years||From registration to 2 years||||||
701361|NCT00057785|Secondary|Rate of Xerostomia at 1 Year (Grade ≥ 2)||From start of treatment to 1 year||||||
701345|NCT00057330|Secondary|Number of Subjects With Newly Acquired Herpes Simplex Virus (HSV)-2 Infection Confirmed by Either Virus Culture or HSV-2 Seroconversion.|The number of subjects with newly acquired HSV-2 infection confirmed by either virus culture or HSV-2 seroconversion was tabulated. Seroconversion to HSV-1 and/or HSV-2 was defined as a positive HSV-1 and/or HSV-2 Western blot in a subject with a previously negative Western blot result for the corresponding HSV type.|Between Months 2 and 20|The Per Protocol cohort for analysis of efficacy (Months 2-20) included all subjects who met inclusion/exclusion criteria, did not meet infection/disease, did not meet censoring criteria, had at least 1 efficacy assessment, received 2 doses of the vaccine within the permitted time interval, with known vaccine administration site and route.||Subjects|||Number
701346|NCT00057330|Secondary|Number of Subjects With Newly Acquired Genital Herpes Disease, Caused by Either Herpes Simplex Virus (HSV)-1 or HSV-2|Genital herpes disease was defined as signs (swelling, papules, vesicles, ulcers, crusts, fissures, erythema, or vaginal discharge) and/or symptoms (pain, burning, itching, tingling, dysuria) which developed on the skin or mucosa of the anogenital region and/or buttocks and laboratory confirmation of Herpes Simplex Virus (HSV)-1 or 2 infection (either concomitant positive HSV culture or HSV seroconversion within 6 months after onset of signs and/or symptoms). Seroconversion to HSV-1 and/or HSV-2 was defined as a positive HSV-1 and/or HSV-2 Western blot in a subject with a previously negative Western blot result for the corresponding HSV type.|Between Months 7 and 20|The Per Protocol cohort for analysis of efficacy (Months 7-20) included all subjects who met inclusion/exclusion criteria, did not meet infection/disease, did not meet censoring criteria, had at least 1 efficacy assessment, received 3 doses of the vaccine within the permitted time interval, with known vaccine administration site and route.||Subjects|||Number
701347|NCT00057330|Primary|Number of Subjects With Newly Acquired Genital Herpes Disease, Caused by Either Herpes Simplex Virus (HSV)-1 or HSV-2|Genital herpes disease was defined as signs (swelling, papules, vesicles, ulcers, crusts, fissures, erythema, or vaginal discharge) and/or symptoms (pain, burning, itching, tingling, dysuria) which developed on the skin or mucosa of the anogenital region and/or buttocks and laboratory confirmation of Herpes Simplex Virus (HSV)-1 or 2 infection (either concomitant positive HSV culture or HSV seroconversion within 6 months after onset of signs and/or symptoms). Seroconversion to HSV-1 and/or HSV-2 was defined as a positive HSV-1 and/or HSV-2 Western blot in a subject with a previously negative Western blot result for the corresponding HSV type.|Between Months 2 and 20|The Per Protocol cohort for analysis of efficacy (Months 2-20) included all subjects who met inclusion/exclusion criteria, did not meet infection/disease, did not meet censoring criteria, had at least 1 efficacy assessment, received 2 doses of the vaccine within the permitted time interval, with known vaccine administration site and route.||Subjects|||Number
701348|NCT00057551|Primary|Remission|Hamilton Depression Scale (HAM-D)<8 and does not meet DSM-IV criteria for Major Depressive Disorder for 2 consecutive visits|12 weeks|||percentage of participants|||Number
701349|NCT00057577|Other Pre-specified|Serious Adverse Events|Number Serious Adverse Events (SAEs) as reported to the Institutional Review Boards and Data Safety Monitoring Board throughout the duration of the study|Throughout study, up to 54 months|||number of SAE's|||Number
701350|NCT00057577|Primary|Number of Participants in Recurrence According to the LIFE and HRSD|Recurrence defined as two consecutive weeks of elevated LIFE PSR scores of 5 or above and HRSD scores of 16 or above (three weeks during period of medication withdrawal)|Measured up to Month 36 from recovery|||Participants|||Count of Participants
701351|NCT00057577|Primary|Number of Participants in Recovery According to the LIFE and HRSD|Six consecutive months following remission without relapse (two weeks of elevated LIFE PSR scores of 4 or more and HRSD scores of 14 and above)|Through 36 months of treatment|||number participants that reach recovery|||Number
701352|NCT00057577|Primary|Number of Participants in Remission According to the Longitudinal Interval Follow-up Evaluation (LIFE) and the Hamilton Rating Scale for Depression (HRSD)|Remission defined as four consecutive weeks of LIFE Problem Symptom Rating (PSR) values of 2 or less and HRSD scores of 8 or less for four consecutive weeks (with partial remission defined as LIFE PSR values of 3 or less and HRSD scores of 12 or less after month 12 only)|Through month 18 of treatment|||number participants that reach remission|||Number
701353|NCT00057681|Secondary|K-SADS Mania Rating Scale|The K-SADS Mania Rating Scale (KMRS) is comprised of 15 items modified from WASH-U-KSADS items. The individual items are scored on a 1-6 severity scale and then these item scores are summed to create an overall KMRS score. Guidelines for interpretation are as follows: 0-11 = no or minimal mania, 12-17 = mild mania, 18-25 = moderate mania, 26+ = marked or worse mania. The maximum possible score is 64.|Measured at Week 8|KMRS data were analyzed for all subjects completing 8 weeks of the study.||units on a scale||Standard Deviation|Mean
701354|NCT00057681|Secondary|Modified Side Effects Form for Children and Adolescents|The Modified Side Effects Form for Children and Adolescents includes 62 potential side effects, with measures of frequency and severity for each item. Frequencies are 0=not present, 1=1-2 days, 2=3-4 days, 3=5-7 days. Severity scores are 0=not present, 1=mild (does not interfere with functioning), 2=moderate (some interference with functioning), 3=severe (functioning is significantly impaired because of side effects). Items for cardiovascular, gastrointestinal, central nervous system, ocular, mouth and nose, genito urinary, dermatology, musculo-skeletal, and other side effects are included. For analyses, side effects that were reported at any frequency and a severity of 2 or greater were considered present.|Measured at Week 8|Modified Side Effects Form for Children and Adolescents data were analyzed for all subjects completing 8 weeks of the study.||side effects at week 8||Standard Deviation|Mean
701355|NCT00057681|Primary|Clinical Global Impressions-Bipolar Mania Improvement|The Clinical Global Impressions-Bipolar (CGI-BP) assessment instrument measured improvement in mania, depression, and overall bipolar illness. The primary outcome measure was mania improvement, which measured the change in mania from baseline. Scores were 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse.|Measured at Week 8|CGI-BP mania improvement data were analyzed for all subjects completing 8 weeks of the study.||units on a scale||Standard Deviation|Mean
701356|NCT00057746|Primary|Incidence of Chronic Neurotoxicity|Chronic neurotoxicity is defined as a drop in one standard error of measurement (SEM) in any one of the three tests comprising the neuropsychological test battery (Hopkins Verbal Learning Test, Controlled Word Association Test, and Trail-Making Test) without development of brain metastasis by one year. The SEM is calculated as the standard deviation of the baseline test multiplied by the square root of one minus the published reliability coefficient for the test.|From study registration to one year.|||percentage of participants||95% Confidence Interval|Number
701362|NCT00057785|Primary|Protocol Compliance of Intensity-modulated Radiotherapy Treatment Delivered|Patients scored by the study chairs as no variation or minor variation were considered compliant, while patients scored as major variation or inevaluable were considered non-compliant. The number being reported is the number non-compliant. A compliance rate of 90% was targeted with 75% or lower being considered unacceptable. Fifty-seven patients were required with types I and II error rates both 0.10. If 10 or more patients out of 57 were non-compliant, the treatment would be unacceptable, per a two-stage Fleming multiple testing procedure.|From start of treatment to end of treatment|First 57 eligible patients who started study treatment.||participants|||Number
701363|NCT00057811|Primary|Toxic Death|Implementation of the toxic death rate stopping rule, a death must be possibly, probably or definitely attributable to Rituximab and/or chemotherapy to be considered a toxic death.|Up to 1 year|Population analyzed includes eligible patients (Group B:46; Group C: 42). Three additional patients (Group B:1; Group C:2) have been excluded as inevaluable per the study chair.||participants|||Number
701364|NCT00057811|Primary|Minimal Residual Disease|The presence or absence of tumor cells at the end of induction assessed by studying tissue and/or blood/marrow. Details of methods and criteria used can be found in Shiramizu at al. BJH 153:758-763, 2011 (full citation in the citation section).|Not Provided|Population analyzed included patients submitting samples for minimal disease assay at end induction||percentage of samples analyzed||95% Confidence Interval|Number
701365|NCT00057811|Primary|Response Rate|Response includes both complete and partial responses. Per protocol, complete Response is defined as the complete disappearance of all clinical evidence of disease by physical examination, by imaging studies, by bone marrow biopsy (where indicated), by CNS evaluation (where indicated) and by biopsy where there is a residual abnormality on an imaging study. Bone marrow must contain <5% blasts. CSF WBC must be <5/μL with no blasts or lymphomatous cells present. Partial response is defined as: at least a 50% reduction in the size of all measurable tumor areas. Each site is to be defined by the product of the maximum length, width and depth (3 dimensions). No lesion may progress. No new lesion may appear. Bone marrow must contain <5% blasts. CSF WBC must be <5/μL with no blasts or lymphomatous cells present..|Up to 5 years|Population analyzed includes eligible patients considered evaluable for response (with measurable disease at on study and adequate assessment of response).||percentage of participants analyzed||95% Confidence Interval|Number
701366|NCT00057811|Primary|Grade ≥ 3 Stomatitis|The incidence of grade ≥ 3 stomatitis. Grade 3 stomatitis: Confluent ulcerations or pseudomembranes; bleeding with minor trauma. Grade 4 stomatitis: Tissue necrosis; Significant spontaneous bleeding; life-threatening consequences|Up to 1 year|Population analyzed includes eligible patients (Group B:46; Group C: 42). Three additional patients (Group B:1; Group C:2) have been excluded as inevaluable per the study chair.||participants|||Number
701367|NCT00057837|Secondary|Overall Survival|Overall survival is defined as the time from randomization to death.|Assessed every 3 months for 2 years, then every 6 months for 1 years|Only eligible and treated patients are included in this analysis.||Months||95% Confidence Interval|Median
701368|NCT00057837|Secondary|Duration of Response|Duration of response is defined as the period measured from the time that measurement criteria are met for complete or partial response (whichever status is recorded first) until the first date that recurrent or progressive disease is objectively documented, taking as reference the smallest measurements recorded since treatment started.|Assessed every 6 weeks while on treatment, and then every 3 months for patients < 2 years from study entry, every 6 months if patient is 2-3 years from study entry.|Only eligible and treated patients with response are included in this analysis.||Months||95% Confidence Interval|Median
701369|NCT00057837|Primary|Proportion of Patients With Objective Response by Solid Tumor Response Criteria (RECIST)|"Per RECIST criteria, Complete response (CR)= disappearance of all target and nontarget lesions Partial response (PR)= >=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits.
Objective response = CR + PR"|Assessed every 6 weeks while on treatment, and then every 3 months for patients < 2 years from study entry, every 6 months if patient is 2-3 years from study entry.|Only treated and eligible patients are included in this analysis.||proportion of participants||90% Confidence Interval|Number
701370|NCT00057863|Secondary|Toxicities, Assessed and Graded According to CTCAE Version 3.0|Exact 95% confidence intervals will be calculated. The 95% confidence interval was not calculated for the toxicities|Up to 7 years|There were 135 cycles administered.||percentage of grade 3/4|||Number
701371|NCT00057863|Secondary|Overall Survival|Assessed by Kaplan-Meier survival analysis and 95% confidence intervals will be calculated using Greenwood's formulae.|From first treatment day until death, assessed up to 7 years|||weeks||95% Confidence Interval|Mean
701372|NCT00057863|Secondary|Progression-free Survival|Assessed by Kaplan-Meier survival analysis and 95% confidence intervals will be calculated using Greenwood's formulae.|From first treatment day until objective or symptomatic progression or death, assessed up to 7 years|||weeks||95% Confidence Interval|Mean
701373|NCT00057863|Primary|Overall Objective Response Rate (CR+PR)|95% confidence interval will be estimated via binomial proportions.|Up to 7 years|||participants|||Number
701374|NCT00057876|Secondary|Overall Response|Response was assessed per Response Evaluation Criteria In Solid Tumors (RECIST) by CT. Overall response included complete response (CR) and partial response (PR). CR was defined as the disappearance of all target and non-target lesions. PR was defined as CR of target lesions and persistence of one or more non-target lesions or at least a 30% decrease in the sum of the longest diameters of target lesions and non-progressive disease in the non-target lesions. The 71 eligible, treated participants were included in the analysis.|assessed at week 8, and every 3 months for 2 years, then every 6 months for year 3|Eligible patients||participants|||Number
701375|NCT00057876|Secondary|Progression-free Survival Time|Time from randomization (registration) to the earlier of disease progression or death. Patients alive and progression-free at last follow-up were censored. Progressive disease was defined as at least a 20% increase in the sum of the longest diameters of target lesions (taking as reference the baseline sum longest diameter), or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Patients were followed every 3 months for 2 years and then every 6 months for year 3. Patients who received treatment beyond 3 years were also followed for survival.|assessed every 3 months for 2 years, then every 6 months for year 3|67 eligible patients with data on progression-free survival(PFS)||Months||95% Confidence Interval|Median
701376|NCT00057876|Primary|Overall Survival Time|Overall survival was defined as the time from randomization (registration) to death from any cause. Patients alive at last follow-up were censored. Patients were followed every 3 months for 2 years and then every 6 months for year 3. Patients received treatment beyond 3 years were also followed for survival.|assessed every 3 months for 2 years, then every 6 months for year 3|71 eligible patients||Months||95% Confidence Interval|Median
701377|NCT00064259|Secondary|Microarray Data|This will be primarily descriptive, and will seek to compare patterns of gene expression pre- and post-treatment.|Up to 12 weeks||||||
701378|NCT00064259|Primary|Maximum Tolerated Dose (MTD) of Oblimersen in Combination With Cisplatin and 5-FU|Adverse events were evaluated according to the National Cancer Institute Common Toxicity Criteria (version 2.0). DLT was defined as grade 3 to 4 hematologic toxicity lasting more than 1 week after 5-FU/cisplatin, grade 3 to 4 nausea or vomiting occurring later than 11 days after cisplatin, grade 3 to 4 diarrhea occurring later than 10 days after 5-FU, and grade 3 to 4 mucositis at the beginning of the next cycle.|21 days|||mg/kg/d|||Number
701379|NCT00064298|Secondary|Cell Proliferation (Ki-67) at Baseline and Week 12|Cell proliferation (Ki-67) at baseline and week 12. Ki67 is a cell proliferation associated nuclear protein. It is measured continuously. Higher values are worse.|baseline and 12 weeks|All participants randomized. Not all participants had p27 or Ki67 data so the sample sizes for the primary and secondary analyses differ from the overall sample size.||percentage||Standard Error|Mean
701380|NCT00064298|Primary|Expression of p27 Cell Cycle Regulatory Protein at Baseline and Week 12|Expression of p27 cell cycle regulatory protein at baseline and week 12. p27 is measured continuously. Lower values are worse.|baseline and 12 weeks|All randomized participants. Not all participants had p27 or Ki67 determined, so the sample sizes for the two outcomes differ from the total sample size.||percentage||Standard Error|Mean
701381|NCT00064350|Secondary|Best Overall Response|The best overall response is the best response (per RECIST 1.0) recorded from randomization until disease progression/recurrence, taking as reference for progressive disease the smallest measurements recorded since randomization.|Assessed every 8 weeks while on treatment. After the end of treatment, assessed every 3 months for 2 years, then every 6 months for 3 years|||Participants|||Number
701382|NCT00064350|Secondary|Overall Survival|Overall survival is defined as the duration from randomization to death or last known alive. Only randomized patients were included in this analysis.|Assessed every 8 weeks while on treatment. After the end of treatment, assessed every 3 months for 2 years, then every 6 months for 3 years|||Months||95% Confidence Interval|Median
701383|NCT00064350|Secondary|Progression-free Survival|Progression-free survival is defined as the duration from randomization to disease progression or death, whichever occurs first. Only randomized patients were included in this analysis.|Assessed every 8 weeks while on treatment. After the end of treatment, assessed every 3 months for 2 years, then every 6 months for 3 years.|||Months||95% Confidence Interval|Median
701384|NCT00064350|Primary|Number of Patients Maintaining Stable Disease or Objective Response 2 Months After Randomization|"Per RECIST Criteria (V1.0):
Complete Response (CR): disappearance of all target lesions Partial Response (PR): >=30% decrease in the sum of the longest diameter of target lesions Progressive Disease (PD): >=20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of longest diameter recorded since randomization, or the appearance of new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD"|Two months after randomization|||participants|||Number
701385|NCT00064987|Secondary|Fertility|Participants actively seeking to conceive.|24 months|Four subjects in Group 1 and two subjects in Group 2 were actively trying to conceive. Fertility was not tracked in subjects not trying to conceive.||Participants|||Count of Participants
701386|NCT00064987|Primary|Sperm Count|Average sperm count after treatment.|month 4 of GnRH treatment|||10^6 sperms/mL||Standard Deviation|Mean
701387|NCT00064987|Primary|Testicular Size (Volume)|Average testicular volume after treatment.|at baseline and month 4 of GnRH treatment|||mL||Standard Deviation|Mean
701388|NCT00064987|Primary|Inhibin B|Average Inhibin B Levels after treatment.|month 4 of GnRH treatment|||pg/mL||Standard Deviation|Mean
701389|NCT00064987|Primary|Testosterone|Average Testosterone levels after treatment.|month 4 of GnRH treatment|||ng/dL||Standard Deviation|Mean
701390|NCT00064987|Primary|FSH|Average Follicle Stimulating Hormone levels after treatment.|month 4 of GnRH treatment|||IU/L||Standard Deviation|Mean
701391|NCT00064987|Primary|LH|Average Luteinizing Hormone levels after treatment.|month 4 of GnRH treatment|||IU/L||Standard Deviation|Mean
701392|NCT00065065|Secondary|Endoscopic Remission at 12 Weeks||12 weeks||||||
701393|NCT00065065|Secondary|Clinical Remission at 12 Weeks|Mayo Score <=2 at 12 weeks post intervention|12 weeks|||participants|||Number
701394|NCT00065065|Primary|Improvement of Signs and Symptoms of UC at 12 Weeks|Mayo score decrease >=2 points adjusted for age and smoking status.|12 weeks|||participants|||Number
701395|NCT00065156|Secondary|Participants With Bone Marrow Progression|"Bone marrow aspirate was assessed by a central reviewer. Progression is represented in two categories according to changes from baseline in French-American-British (FAB) classification (see Baseline Characteristics):
Baseline classification of refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) to a during treatment (plus 30 days) classification of refractory anemia with excess blasts (RAEB).
Any baseline FAB classification to a during treatment (plus 30 days) classification of acute myeloid leukemia (AML)."|up to 2 years|Modified intent to treat population of participants with adequate bone marrow aspirate at baseline.||participants|||Number
701396|NCT00065156|Secondary|Participants With Complete or Partial Bone Marrow Improvement|Bone marrow aspirates were assessed by a central reviewer. A complete bone marrow improvement required a baseline French-American-British (FAB) classification (see Baseline Characteristics) of refractory anemia (RA), refractory anemia with ringed sideroblasts (RARS), refractory anemia with excess blasts (RAEB) or chronic myelomonocytic leukemia (CMML) and a during study assessment of no MDS. A partial bone marrow improvement reflected an improved FAB classification compared to baseline (e.g. RARS to RA) but evidence of MDS continued to exist.|up to 2 years|Modified intent to treat population of participants with adequate bone marrow aspirate at baseline.||participants|||Number
701408|NCT00065260|Primary|No Longer Meeting Criteria for Severe Aplastic Anemia.||6 months|||participants|||Number
701397|NCT00065156|Secondary|Participant Counts of Absolute Neutrophil Count (ANC) Response|"Major neutrophil response: participants with a minimum pretreatment ANC concentration of < 1500/mm^3 in all values obtained within 56 days of start of treatment, a ≥ 100% increase or an absolute increase of
≥ 500/mm^3, whichever was greater (at least to be ≥ 500/mm^3), sustained for 56 consecutive days. Minor neutrophil response: participants with a minimum pretreatment ANC concentration of < 1500/mm^3, an increase in ANC concentration of ≥ 100% sustained for 56 consecutive days."|up to 2 years|Evaluable participants from the modified intent to treat population. Evaluable participants are required to have a baseline absolute neutrophil count (ANC) <1 * 10^9/L.||participant|||Number
701398|NCT00065156|Secondary|Participant Counts of Platelet Response|"Major platelet response: participants with a minimum pretreatment platelet of <100,000/mm^3 in all values within 56 days of start of treatment, an absolute increase of ≥30,000/mm^3 sustained for ≥56 consecutive days. In platelet transfusion-dependent participants, a major response was stabilization of platelet counts and platelet transfusion independence.
Minor platelet response: participants with a minimum pretreatment platelet of <100,000/mm^3, a ≥ 50% increase in platelet count with a net increase >10,000/mm^3 for a consecutive 56-day period in the absence of platelet transfusions."|up to 2 years|Evaluable participants from the modified intent to treat population. Participants must have a baseline platelet count <100 * 10^9/L to be included in the analysis.||participants|||Number
701399|NCT00065156|Secondary|Participant Counts of Cytogenetic Response|"Participants deemed evaluable by the central cytogenetic review had their cytogenetic response categorized as major or minor. A major cytogenetic response was defined as ≥ 20 metaphases recorded at baseline, and at least
1 post baseline evaluation with ≥ 20 metaphases analyzed with no abnormal metaphases observed. A minor cytogenetic response was defined as ≥ 20 metaphases analyzed at baseline, and at least 1 post baseline evaluation with ≥ 20 metaphases analyzed with a ≥ 50% reduction in the proportion of hematopoietic cells with cytogenetic abnormalities compared with baseline."|up to 2 years|Evaluable participants from the modified intent to treat population. Evaluable participants had ≥ 20 metaphases analyzed at baseline during the 56-day period immediately preceding the first day of study drug intake and ≥ 20 metaphases analyzed at least once at postbaseline visits.||participants|||Number
701400|NCT00065156|Secondary|Change in Hemoglobin Concentration From Baseline to Maximum Value During Response Period for Responders|The change from baseline in hemoglobin for participants who became RBC-transfusion independent. The maximum hemoglobin value obtained during the response period is used in the calculation of change from baseline.|Baseline (Day -54 to Day 0), During study (Day 1 up to 2 years)|Modified intent to treat population who achieved transfusion independence||g/dL||Standard Deviation|Mean
701401|NCT00065156|Secondary|Kaplan Meier Estimate for Duration of Transfusion Independence Response|Duration of response is measured from the first of the consecutive 56 days during which the participant was free of RBC transfusions to the date of the first RBC transfusion after this period. Duration of response was censored at the date of last visit for participants who maintained transfusion independence.|up to 2 years|Modified intent to treat population who achieved transfusion independence||weeks||95% Confidence Interval|Median
701402|NCT00065156|Secondary|Participants Who Relapsed or Maintained Their Transfusion Independence After Achieving Transfusion Independence During the Study|Transfusion independence was defined as the absence of an intravenous infusion of any RBC transfusion during any consecutive “rolling” 56 days during the treatment period (e.g., Days 1 to 56, Days 2 to 57, Days 3 to 58, etc.), and accompanied by at least a 1 g/dL increase from screening/baseline in hemoglobin. Participants who relapsed required a transfusion after the period of transfusion independence. Participants who maintained transfusion independence did not require a transfusion during the remainder of the study.|up to 2 years|Modified intent to treat population who achieved transfusion independence||participants|||Number
701403|NCT00065156|Secondary|Time to Transfusion Independence|Transfusion independence was defined as the absence of an intravenous infusion of any RBC transfusion during any consecutive “rolling” 56 days during the treatment period (e.g., Days 1 to 56, Days 2 to 57, Days 3 to 58, etc.), and accompanied by at least a 1 g/dL increase from screening/baseline in hemoglobin. Time to transfusion independence was defined as the day of the first dose of study drug to the first day of the first 56-day RBC transfusion-free period.|up to 2 years|Modified intent to treat population who achieved transfusion independence||weeks||Standard Deviation|Mean
701404|NCT00065156|Secondary|Participants With a >= 50% Decrease From Baseline in Red Blood Cell (RBC) Transfusion Requirements Over Any Consecutive 56 Days During Study|A participant was categorized as having a transfusion reduction response if there was a ≥ 50% decrease from pretreatment transfusion requirements (before the start of the study mediation) compared to any consecutive 56 days during the study (i.e. post treatment).|Baseline (Day -54 to Day 0), During study (Day 1 up to 2 years)|"Modified Intent to Treat (MITT)
diagnosis of low- or int-1-risk MDS associated with a del(5q) cytogenetic abnormality based on central hematologic and cytogenetic reviewers confirmation
received ≥2 transfusions in each of the 8-week periods during the 16 week pre-treatment period
received ≥1 dose of study drug"||participant|||Number
701405|NCT00065156|Secondary|Participants With Adverse Experiences|"Counts of study participants who had adverse events (AEs) during the study. A participant with multiple occurrences of an adverse event within a category is counted only once in that category. Adverse events were evaluated by the investigator.
The National Cancer Institute (NCI)'s Common Toxicity Criteria for AEs (NCI CTC) was used to grade AE severity. Severity grade 3= severe and undesirable AE. Severity grade 4= life-threatening or disabling AE."|Up to 2 Years|Safety population included all participants who received at least one dose of study drug.||participants|||Number
701406|NCT00065156|Primary|Participants Who Achieved Red Blood Cell (RBC) -Transfusion Independence|Number of participants who achieved RBC-transfusion independence, which was defined as the absence of an intravenous infusion of any RBC transfusion during any consecutive “rolling” 56 days during the treatment period (eg, Days 1 to 56, Days 2 to 57, Days 3 to 58, etc), and accompanied by at least a 1 g/dL increase from screening/baseline in hemoglobin.|Up to 2 years|"Modified Intent to Treat (MITT)
diagnosis of low- or int-1-risk MDS associated with a del(5q) cytogenetic abnormality based on central hematologic and cytogenetic reviewers confirmation
received ≥2 transfusions in each of the 8-week periods during the 16 week pre-treatment period
received ≥1 dose of study drug"||participants|||Number
701407|NCT00065260|Secondary|Secondary Endpoints Will Include: Relapse; Clonal Evolution to Myelodysplastic Syndrome (MDS), Paroxysmal Nocturnal Hemoglobinuria (PNH) or Acute Leukemia||months/years||||||
701409|NCT00065429|Primary|Response Evaluation Criteria in Solid Tumors (RESIST) [Phase I and II]|Response was evaluated by RESIST and Investigator assessment at baseline and every 6 weeks. CR: all target lesions disappear with no clinical or radiographic evidence of disease progression in 2 observations. PR: At least 30% decrease in sum of the longest diameters of target lesions shown in 2 observations. SD: does not qalify for PR or PD based on 2 observations. PD: Either a) the appearance of one or more new lesions, or b) at least a 20% increase in the sum of longest diameters of target lesions|6 weeks|All patients with a baseline and follow up imaging scan were evaluated. Data represents information following the first cycle of treatment.||participants|||Number
701410|NCT00065429|Primary|Phase I Toxicity Based Upon Adverse Events Clasified by the NCI Common Terminology Ctireria Version 2.0 (Phase I)|Dose limiting toxicities graded according to common terminology criteria for advers events, version 2.0 and defined as AEs (probably/definitely related to study drug) meeting the NCI CTC criteria, assessed on the basis of the first cycle of therapy (4 weeks of weekly dosing/2 week fu): Hematologic Tox (Grade 4 neutropenia ≥ 5 days, Grade 4 thrombocytopenia, neutropenic infection); Non-Hem Toxicity: (Any grade 3 or 4 non-hematologic toxicity, excluding nausea, vomiting, diarrhea and alopecia); Toxicity present at Screening (concurrent conditions), an increase in severity of 2 or more grades.|every 6 weeks|All Phase I enrolled patients who received study drug were analyzed for DLTs.||participants|||Number
701411|NCT00065442|Secondary|Time to Objective Disease Progression|Measured by imaging studies; confirmed by independent imaging review|Analysis conducted at the time of overall survival analysis|||Weeks||95% Confidence Interval|Median
701412|NCT00065442|Primary|Overall Survival|Time from randomization until death due to any cause.|Event-driven timeframe. Final analysis at 331 events.|||Months||95% Confidence Interval|Median
701413|NCT00065468|Secondary|European Quality of Life Health Questionnaire (EQ-5D) - Index Score|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. EQ-5D index measured 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Range of EQ-5D index score = -0.594 to 1 where higher scores indicated a better health state.|Baseline|ITT;(N)=participants with evaluable data. Week 12 and 32 data collected for individual participants but not summarized.||units on a scale||Full Range|Median
701414|NCT00065468|Secondary|Quality-adjusted Time Without Symptoms or Toxicity (Q-TWiST)|The Q-Twist is not a score calculated for each participant but is defined only on a by treatment group basis. For each treatment group, it is the weighted sum of the mean durations of the health states Tox, Twist, and Relapse. Tox is defined as time with severe toxicity related to treatment; Twist: time without symptoms or toxic side effects; and Relapse: time after relapse/progression. The mean duration of each health state is calculated based on the area under the Kaplan Meier curve pertaining to that health state. There is no direct method for calculating the “dispersion” of Q-Twist, and it is typically done using bootstrap method for purposes of inference (see, e.g., Glasziou PP, Simes RJ, Gelber RD. Quality adjusted survival analysis. Stat Med 1990; 9: 1259-76). In practice, as apparently in the case with this study, the intermediate values resulting from the bootstrap exercise were not displayed.|Baseline to Month 80|ITT||months|||Number
701415|NCT00065468|Secondary|Time to Treatment Failure (TTF)|TTF is defined as the time from the date of randomization to the date of PD or death, withdrawal from treatment due to an adverse event (AE), withdrawal of voluntary consent, or lost to follow-up, whichever occurred first, censored at the date of the conclusion of treatment phase.|Baseline, every month until tumor progression or death (up to Month 80)|ITT||months||95% Confidence Interval|Median
701416|NCT00065468|Secondary|Duration of Response (DR)|DR: Time from first documentation of objective tumor response to first date that recurrence or progressive disease (PD) was objectively documented, taking as a reference for PD, the smallest sum LD recorded since randomization.|Baseline, every month until tumor progression or death (up to Month 80)|ITT subset of participants who had a response||months||95% Confidence Interval|Median
701417|NCT00065468|Secondary|Percentage of Participants With Clinical Benefit|Clinical benefit: confirmed CR or PR or had stable disease (SD) lasting at least 24 weeks. CR was the disappearance of all target lesions and non target lesions. PR was at least a 30% decrease in sum of the LD of target lesions, taking as reference the baseline sum LD. SD was having neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|Baseline, every 2 months until tumor progression or death (up to Month 80)|ITT||percentage of participants||95% Confidence Interval|Number
701418|NCT00065468|Secondary|Percentage of Participants With Objective Response|Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was the disappearance of all target lesions and non target lesions. PR was at least a 30 percent (%) decrease in sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|Baseline, every 2 months until tumor progression or death (up to Month 80)|ITT||percentage of participants||95% Confidence Interval|Number
701419|NCT00065468|Secondary|Progression-Free Survival (PFS)|PFS based on Independent Central Review Assessment. The period from randomization until disease progression, death or date of last contact.|Baseline, monthly until tumor progression or death (up to Month 80)|ITT||months||95% Confidence Interval|Median
701420|NCT00065468|Primary|Overall Survival (OS)|Overall survival is the duration from randomization to death. For participants who are alive, overall survival is censored at the last contact.|Baseline up to Month 80|Intent-to-treat (ITT) Population: all randomized participants||months||95% Confidence Interval|Median
701421|NCT00065507|Secondary|Number of Participants Undergoing Liver Transplant - On-Treatment or 24-Week Follow-Up||On-treatment=up to Week 48 (Day 336); if discontinued early, all data up to 5 days after discontinuation date. 24-week follow-up=limited to end-of-dosing values and those from 6 days after last dose of study therapy to end of follow-up.|The on-treatment safety data set contains data from all randomized subjects treated with at least 1 dose of study therapy, ETV or ADV. Treatment group for safety data set is based on actual treatment received.||participants|||Number
701422|NCT00065507|Secondary|Number of Participants With Malignant Neoplasms - On Treatment or During 24-Week Follow-up Period|Data includes type of malignant neoplasm.|On-treatment=up to Week 48 (Day 336); if discontinued early, all data up to 5 days after discontinuation date. 24-week follow-up=limited to end-of-dosing values and those from 6 days after last dose of study therapy to end of follow-up.|The on-treatment safety data set contains data from all randomized subjects treated with at least 1 dose of study therapy, ETV or ADV. Treatment group for safety data set is based on actual treatment received.||participants|||Number
701423|NCT00065507|Secondary|Number of Participants With Alanine Aminotransferase (ALT) Flares - On Treatment|ALT flare=ALT > 2 x baseline and > 10 x upper limit of normal (ULN) by clinical laboratory evaluation. Table includes number of participants with selected clinical events and/or laboratory abnormalities during ALT flares. Selected clinical events during ALT flares=ascites, hepatic encephalopathy, jaundice, bacterial peritonitis. Selected Laboratory abnormalities during ALT flares=international normalized ratio > 1.5 or prothrombin time >= 1.2 x ULN and total bilirubin >2.5 mg/dL and > 1 mg/dL increase from baseline.|On-treatment=up to Week 48 (Day 336); if discontinued early, all data up to 5 days after discontinuation date.|Treated participants - as treated. The on-treatment safety data set contains data from all randomized subjects treated with at least 1 dose of study therapy, ETV or ADV. Treatment group for safety data set is based on actual treatment received.||participants|||Number
701424|NCT00065507|Secondary|Number of Participants With Treatment-Emergent Grade 3/4 Laboratory Abnormalities - Week 48 and Cumulative Data|Grade 3/4 laboratory abnormalities (hematology, electrolyte, lipase, liver function, metabolic, renal function, urinalysis). The Week 48 data set was used to evaluate the Week-48 on-treatment safety. The cumulative data set was used to evaluate the safety while on treatment. Common Terminology Criteria for Adverse Events v3.0 (CTCAE) Grades:1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death.|Week 48=all on-treatment laboratory measurements up to Week 48. Cumulative data = on-treatment laboratory measurements obtained after the start of therapy and no more than 5 days after the last dose of study therapy.|As-treated population (all randomized subjects treated with at least 1 dose of study therapy, ETV or ADV, based on actual treatment received).||participants|||Number
701425|NCT00065507|Secondary|Cumulative Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, HCC, Discontinuations Due to AEs, and Confirmed Creatinine Increase >=0.5 mg/dL|AE=any new untoward medical occurrence/worsening of a pre-existing medical condition regardless of causal relationship. SAE=any untoward medical occurrence at any dose that: results in death; is life-threatening; requires/prolongs inpatient hospitalization; results in persistent/significant disability; is cancer; is congenital anomaly/birth defect; results in drug dependency/abuse; is an important medical event. Grades:1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death. Confirmed increase in serum creatinine=values ≥0.5 mg/dL compared with baseline on 2 sequential measures.|on-treatment events obtained after the start of therapy and no more than 5 days after the last dose of study therapy.|As-treated population (all randomized subjects treated with at least 1 dose of study therapy, ETV or ADV, based on actual treatment received). Note that 5 additional enrolled participants died prior to initiation of treatment and are not included in this table.||participants|||Number
701426|NCT00065507|Secondary|Number of Hepatocellular Carcinoma (HCC) Events at Different Time Points Through Week 48|HCC-free survival was analyzed using life tables. Measured values show the number of HCC events among treated participants at given time points.|Week 48|Treated, through Week 48 - (analyzed as-treated). (Week 48 on-treatment safety data contain all on-treatment data up to study Day 336, if the subject is still on treatment. If the subject discontinued before study Day 336, then all data up to 5 days after the discontinuation date were included.) n=number of participants at risk at each timepoint.||HCC events|||Number
701427|NCT00065507|Secondary|Participants Achieving Platelet Count Normalization Through Week 48|Number of participants who achieved normalization of platelet count (>= 1 x lower limit of normal [LLN]), a measure of liver function, at specific timepoints.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48|Treated subjects - as-randomized. Excludes participants with normal prothrombin time at baseline. Non-completer = failure.||participants|||Number
701428|NCT00065507|Secondary|Participants Achieving Total Bilirubin Normalization Through Week 48|Number of participants who achieved normalization of total bilirubin (<= 1 x ULN), a measure of liver function, at specific timepoints.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48|Treated subjects - as-randomized. Excludes participants with normal prothrombin time at baseline. Non-completer = failure.||participants|||Number
701429|NCT00065507|Secondary|Participants Achieving Prothrombin Time Normalization Through Week 48|Number of participants who achieved normalization of prothrombin time (<= 1 x ULN), a measure of liver function, at specific timepoints.|Baseline, Week4, Week 8, Week 12, Week 24, Week 36, Week 48|Treated subjects - as-randomized. Excludes participants with normal prothrombin time at baseline. Non-completer = failure.||participants|||Number
701430|NCT00065507|Secondary|Participants Achieving Albumin Normalization Through Week 48|Number of participants who achieved normalization of albumin (>= 1 x lower limit of normal [LLN]), a measure of liver function, at specific timepoints.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48|Treated subjects (as randomized). Excludes subjects with normal albumin at Baseline. Non-completer = failure.||participants|||Number
701431|NCT00065507|Secondary|Change From Baseline in Platelet Count Through Week 48|Mean baseline platelet count and mean change from baseline in platelet count at specific timepoints. Platelets are the smallest particles found in the blood, which play a major role in forming blood clots. Normal range for platelets = 140 - 450 X 10*9 c/L.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48|Treated, as-randomized. Subjects with normal values at baseline were excluded from the analysis. n=number of participants with value at baseline and given timepoint.||10*9 c/L||Standard Error|Mean
701432|NCT00065507|Secondary|Mean Change From Baseline in Total Bilirubin Through Week 48|Mean total bilirubin levels, and mean change from baseline in total bilirubin, a measure of liver secretory function.Normal range for total bilirubin = 0.2 - 1.2 mg/dL.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48|Treated, as-randomized. Subjects with normal values at baseline were excluded from the analysis. n=number of participants with value at baseline and given timepoint.||mg/dL||Standard Error|Mean
701433|NCT00065507|Secondary|Mean Change From Baseline in Prothrombin Time Through Week 48|Mean prothrombin time, and mean change from baseline in prothrombin time, a measure of synthetic liver function. Prothrombin time is the time it takes (in seconds) for a sample of blood to clot. Normal range for prothrombin time (PT) = 10-13 seconds.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48|Treated, as-randomized. Subjects with normal values at baseline were excluded from the analysis. n=number of participants with value at baseline and given timepoint.||seconds||Standard Error|Mean
701434|NCT00065507|Secondary|Change From Baseline in Albumin Through Week 48|Mean albumin levels, and mean change from baseline in albumin, a measure of synthetic liver function. Normal range for albumin = 3.5 - 5.3 g/dL.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48|Treated participants - as randomized; n=number of participants with value at baseline and given timepoint.||g/dL||Standard Error|Mean
701435|NCT00065507|Secondary|Mean Changes From Baseline in Quality of Life, as Measured by EuroQol-5D (EQ-5D) at Weeks 24 and 48|The EQ-5D has 5 attributes (mobility, self-care, usual activity, pain/discomfort, and anxiety/depression), each with 3 levels (no problem, some problems, and major problems). This algorithm gives valuation (weights) to each of the 15 responses on the form. Each valuation is a negative number, subtracted from the maximum score of 1 (perfect well being). The overall health index score ranges from 0 (dead) to 1 (perfect health) value scale, and the visual analog scale ranges from 0 to 100. Item weights will be obtained from the EuroQol group.|Baseline, Week 24, Week 48|This endpoint was not analyzed due to lack of complete data at 48 Weeks, but will be assessed at future time points.|||||
701436|NCT00065507|Secondary|Mean Changes From Baseline in Quality of Life as Measured by the Short Form 36 (SF-36)|Scoring for the SF-36 will be done using the algorithm developed by the Research ANd Development(RAND) Corporation (a scale of 0-100). Higher scores represent better quality of life. Coding for items with 2-category responses=0 and 100; 3-category=0/50/100; 5-category=0/25/50/75/100; 6-category=0/20/40/60/80/100. Scores of items in the same scale are combined to create the 8 scale scores (physical functioning, role-physical, bodily-pain, general health, vitality, social functioning, role-emotional, mental health). Physical and mental health composite scores will be computed for the group.|Baseline, Week 24, Week 48|This endpoint was not analyzed due to lack of complete data at 48 Weeks, but will be assessed at future time points.|||||
701437|NCT00065507|Secondary|Improvement or No Worsening in MELD Score Through Week 48|Participants with improvement or no worsening (any decrease or no change from baseline in score) in MELD score through Week 48. The Model for End-Stage Liver Disease (MELD), is a scoring system for assessing the severity of chronic liver disease. MELD uses the patient's values for serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR) to predict survival. In interpreting the MELD Score in hospitalized patients, the 3 month mortality is: 40 or more=100% mortality; 30-39=83% mortality; 20-29=76% mortality; 10-19=27% mortality; <10=4% mortality.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 48|Treated Subjects - As-Randomized, modified intention-to-treat (ITT) efficacy data set (includes on-treatment data collected for treated subjects. On-treatment data are those obtained after the start of therapy and no more than 5 days after the last dose of study therapy.) n=number of participants with measurement at baseline and timepoint.||Participants|||Number
701438|NCT00065507|Secondary|Mean Change From Baseline in Model for End-Stage Liver Disease (MELD) Scores From Baseline Through Week 48|Adjusted mean change from baseline in MELD score through Week 48 (adjusted for baseline value). The Model for End-Stage Liver Disease (MELD), is a scoring system for assessing the severity of chronic liver disease. MELD uses the patient's values for serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR) to predict survival. In interpreting the MELD Score in hospitalized patients, the 3 month mortality is: 40 or more=100% mortality; 30-39=83% mortality; 20-29=76% mortality; 10-19=27% mortality; <10=4% mortality.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48|Treated participants - as-randomized populations; n=number of participants with assessment at baseline and timepoint. The modified intention-to-treat (ITT) efficacy data set included on-treatment data collected for treated subjects. On-treatment data are obtained after the start of therapy and <=5 days after the last dose of study therapy.||units on a scale||Standard Error|Mean
701439|NCT00065507|Secondary|Number of Participants With Improvement in Child-Pugh Class at Week 24 and Week 48|Number of Participants in each group with improvement in Child-Pugh score from baseline to Week 48 as measured by improvement in Child-Pugh class. Improvement in Child-Pugh Class is defined as change from B to A or C to A. Evaluable subjects are subjects with Child-Pugh Class B or C at Baseline. Child-Pugh classification assesses the prognosis of chronic liver disease by 5 clinical measures, scored 1-3 each (most severe derangement=3). Score range: 5 (best prognosis) to 15 (worst prognosis). Child-Pugh class A to C employs the added score from above: 5-6=Class A; 7-9=Class B; 10-15=Class C.|Week 24, Week 48|Treated participants (as-randomized). The modified intention-to-treat (ITT) efficacy data set included on-treatment data collected for treated subjects. On-treatment data are those obtained after the start of therapy and no more than 5 days after the last dose of study therapy.||Participants|||Number
701440|NCT00065507|Secondary|Change From Baseline in Child-Pugh Score Through Week 48|Mean change from baseline in Child-Pugh score through week 48. Child-Pugh classification assesses the prognosis of chronic liver disease by 5 clinical measures, scored 1-3 each (most severe derangement=3). Score range: 5 (best prognosis) to 15 (worst prognosis).|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48|Treated Subjects - As-Randomized, modified intention-to-treat (ITT) efficacy data set (includes on-treatment data collected for treated subjects. On-treatment data are those obtained after the start of therapy and no more than 5 days after the last dose of study therapy.) n=number of participants with measurement at baseline and timepoint.||units on a scale||Standard Error|Mean
701441|NCT00065507|Secondary|Number of Participants With Improvement or No Worsening in Child-Pugh Score From Baseline to Week 48|Number of participants in each group with improvement or no worsening in Child-Pugh score from baseline to Week 48 as measured by improvement or no worsening in Child-Pugh score. Child-Pugh classification assesses the prognosis of chronic liver disease by 5 clinical measures, scored 1-3 each (most severe derangement=3). Score range: 5 (best prognosis) to 15 (worst prognosis).|Baseline, Week 4, Week 8, Week 12, Week 24, Week 48|Treated participants (as-randomized). Non-completer=Failure. The modified intention-to-treat (ITT) efficacy data set included on-treatment data collected for treated subjects. On-treatment data are those obtained after the start of therapy and no more than 5 days after the last dose of study therapy.||Participants|||Number
701442|NCT00065507|Secondary|>=2-Point Reduction From Baseline in Child-Pugh Score Through Week 48|Child-Pugh classification assesses the prognosis of chronic liver disease by 5 clinical measures, scored 1-3 each (most severe derangement=3). Score range: 5 (best prognosis) to 15 (worst prognosis).|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48|Treated Subjects-As-Randomized, modified intention-to-treat (ITT) efficacy data set (includes on-treatment data collected for treated subjects. On-treatment data are those obtained after start of therapy and <=5 days after the last dose of study therapy.) Non-completer=Failure. n=number of participants with measurement at baseline and timepoint.||Participants|||Number
701443|NCT00065507|Secondary|Number of Subjects Achieving Composite Endpoint (HBV DNA < 10*4 Copies/mL by PCR Assay and Normal ALT [≤ 1.0 x ULN]) Through Week 48||Baseline, Week 4, Week 8, Week 12, Week 24, Week 48|Treated Subjects - As-Randomized, modified intention-to-treat (ITT) efficacy data set (includes on-treatment data collected for treated subjects. On-treatment data are those obtained after the start of therapy and no more than 5 days after the last dose of study therapy.) n=number of participants with measurement at baseline and timepoint.||Participants|||Number
701444|NCT00065507|Secondary|Number of Participants Achieving Alanine Transaminase (ALT) Normalization (≤1.0 x Upper Limit of Normal [ULN]) at Weeks 24 and 48|Number of participants in each group who achieved ALT normalization (≤1.0 x upper limit of normal [ULN]) among those with baseline ALT >1.0 x ULN at Weeks 24 and 48|Week 24, Week 48|Treated Subjects - As-Randomized population, responders only (non-completer=failure).Participants in each group who achieved ALT normalization among those with baseline ALT >1.0 x ULN.||Participants|||Number
701445|NCT00065507|Secondary|Number of Participants With HBV DNA < 300 Copies/mL by PCR At Week 48||Week 48|Treated Subjects - As-Randomized population, responders only (non-completer=failure).||Participants|||Number
701446|NCT00065507|Secondary|Number of Participants With HBV DNA < 300 Copies/mL by PCR At Week 24||Week 24|Treated Subjects - As-Randomized population, responders only (non-completer=failure).||participants|||Number
701447|NCT00065507|Secondary|Change From Baseline in HBV DNA by PCR at Week 48|Mean change from baseline in HBV DNA by PCR at Week 48, adjusted for baseline HBV DNA and LVDr Status.|Baseline, Week 48|Treated Subjects - As-Randomized, modified intention-to-treat (ITT) efficacy data set. Includes on-treatment data (obtained after the start of therapy and no more than 5 days after the last dose of study therapy) collected for treated subjects. Includes those participants with PCR measurements in the Week 48 analysis window.||log10 copies/mL||Standard Error|Mean
701448|NCT00065507|Primary|Change From Baseline in Hepatitis B Virus (HBV) DNA by Polymerase Chain Reaction (PCR) at Week 24|Mean reduction in serum HBV DNA determined by PCR assay (log10 copies/mL) at Week 24 adjusted for baseline HBV DNA and lamivudine resistance (LVDr) status, based on linear regression analysis.|Baseline, Week 24|Treated Subjects - As-Randomized, modified intention-to-treat (ITT) efficacy data set. Includes on-treatment data (obtained after the start of therapy and no more than 5 days after the last dose of study therapy) collected for treated subjects. Includes those participants with PCR measurements in the Week 24 analysis window.||log10 copies/mL||Standard Error|Mean
701449|NCT00065611|Secondary|CKD-EPI eGFR|Estimate glomerular filtration rate (eGFR) using the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) formula.|48 weeks from baseline|||ml/min/1.73m^2||Standard Deviation|Mean
701450|NCT00065611|Secondary|Urine Protein||48 weeks from baseline|||g/d||Standard Deviation|Mean
701451|NCT00065611|Primary|Remission Status of Patients After Intermittent Oral Dexamethasone Administered Over 48 Weeks|Complete remission is defined as proteinuria <0.3 g/d. Partial remission is defined as a 50% fall in proteinuria compared to baseline, proteinuria <3.5 g/d, and a preserved estimated glomerular filtration rate (eGFR), specified as >60% of baseline. Limited response is defined as a 50% fall in proteinuria compared to baseline. All other outcomes are described as non-response.|48 weeks from baseline|ITT||participants|||Number
701452|NCT00065806|Secondary|Change in Homocysteine||Change from baseline to 36 months|||μmoles/liter||95% Confidence Interval|Mean
701453|NCT00065806|Secondary|Change in Lipoprotein A||Change from baseline to 36 months|||mg/dl||95% Confidence Interval|Mean
701454|NCT00065806|Secondary|Change in Triglycerides||Change from baseline to 36 months|||mg/dl||95% Confidence Interval|Mean
701455|NCT00065806|Secondary|Change in LDL Cholesterol||Change from baseline to 36 months|||mg/dl||95% Confidence Interval|Mean
701456|NCT00065806|Secondary|Change in HDL Cholesterol||Change from baseline to 36 months|||mg/dl||95% Confidence Interval|Mean
701457|NCT00065806|Secondary|Change in Total Cholesterol||Change from baseline to 36 months|||mg/dl||95% Confidence Interval|Mean
701458|NCT00065806|Secondary|Change in Natural Log of mg/L for hsCRP||Change from baseline to 36 months|||natural log of mg/L||95% Confidence Interval|Mean
701459|NCT00065806|Secondary|Change in Mean-Mean Near Wall CIMT|For the near wall measurements for each side and segment, mean CIMT values were averaged over the 4 angles of interrogation to produce 6 summary variables (right common near wall mean, right bifurcation near wall mean, right internal near wall mean, left common near wall mean, left bifurcation wall mean and left internal far wall mean). These 6 summary variables were then averaged to estimate a single mean-mean far wall CIMT for each participant visit.|Change from baseline to 36 months|||mm||95% Confidence Interval|Mean
701460|NCT00065806|Secondary|Change in Mean-Max Near Wall CIMT|For the near wall measurements for each side and segment, the maximum CIMT over the 4 angles of interrogation was selected to produce 6 summary variables (right common near wall max, right bifurcation near wall max, right internal near wall max, left common near wall max, left bifurcation near wall max, and left internal near wall max). These 6 summary variables were then averaged to estimate a single mean-max near wall CIMT for each participant visit.|Change from baseline to 36 months|||mm||95% Confidence Interval|Mean
701461|NCT00065806|Secondary|Change in Mean-Mean Far Wall CIMT|For the far wall measurements for each side and segment, mean CIMT values were averaged over the 4 angles of interrogation to produce 6 summary variables (right common far wall mean, right bifurcation far wall mean, right internal far wall mean, left common far wall mean, left bifurcation far wall mean and left internal far wall mean). These 6 summary variables were then averaged to estimate a single mean-mean far wall CIMT for each participant visit.|Change from baseline to 36 months|||mm||95% Confidence Interval|Mean
701462|NCT00065806|Secondary|Change in Mean-Max Far Wall CIMT|For the far wall measurements for each side and segment, the maximum CIMT over the 4 angles of interrogation was selected to produce 6 summary variables (right common far wall max, right bifurcation far wall max, right internal far wall max, left common far wall max, left bifurcation far wall max, and left internal far wall max). These 6 summary variables were then averaged to estimate a single mean-max far wall CIMT for each participant visit.|Change from baseline to 36 months|||mm||95% Confidence Interval|Mean
701463|NCT00065806|Secondary|Change in Mean-Mean Bifurcation CIMT|For the bifurcation arterial segment, mean CIMT values were averaged across angles by side and wall to produce 4 summary variables (right bifurcation near wall mean, right bifurcation far wall mean, left bifurcation near wall mean and left bifurcation far wall mean). These summary variables were then averaged to estimate a single mean-mean bifurcation CIMT for each participant visit.|Change from baseline to 36 months|||mm||95% Confidence Interval|Mean
701464|NCT00065806|Secondary|Change in Mean-Max Bifurcation CIMT|For each side and wall of the bifurcation arterial segment, the maximum CIMT over the 4 angles of interrogation was selected to produce 4 summary variables (right bifurcation near wall max, right bifurcation far wall max, left bifurcation near wall max and left bifurcation far wall max). These summary variables were then averaged to estimate a single mean-max bifurcation CIMT for each participant visit.|Change from baseline to 36 months|||mm||95% Confidence Interval|Mean
701465|NCT00065806|Secondary|Change in Mean-Mean Internal CIMT|For the internal carotid arterial segment, mean CIMT values were averaged across angles by side and wall to produce 4 summary variables (right internal near wall mean, right internal far wall mean, left internal near wall mean and left internal far wall mean). These summary variables were then averaged to estimate a single mean-mean internal CIMT for each participant visit.|Change from baseline to 36 months|||mm||95% Confidence Interval|Mean
701466|NCT00065806|Secondary|Change in Mean-Max Internal CIMT|For each side and wall of the internal carotid arterial segment, the maximum CIMT over the 4 angles of interrogation was selected to produce 4 summary variables (right internal near wall max, right internal far wall max, left internal near wall max and left internal far wall max). These summary variables were then averaged to estimate a single mean-max internal CIMT for each participant visit.|Change from baseline to 36 months|||mm||95% Confidence Interval|Mean
701467|NCT00065806|Secondary|Change in Mean-Max Common CIMT|For each side and wall of the common carotid arterial segment, the maximum CIMT over the 4 angles of interrogation was selected to produce 4 summary variables (right common near wall max, right common far wall max, left common near wall max and left common far wall max). These summary variables were then averaged to estimate a single mean-max common CIMT for each participant visit.|Change from baseline to 36 months|||mm||95% Confidence Interval|Mean
701468|NCT00065806|Secondary|Change in Mean-Mean CIMT|For each side, segment and wall, mean CIMT values were averaged over the 4 angles of interrogation to produce 12 summary variables (right common near wall mean, right common far wall mean, right bifurcation near wall mean, right bifurcation far wall mean, right internal near wall mean, right internal far wall mean, left common near wall mean, left common far wall mean, left bifurcation near wall mean, left bifurcation far wall mean, left internal near wall mean and left internal far wall mean). These 12 summary variables were then averaged to estimate a single mean-mean CIMT for each participant visit.|Change from baseline to 36 months|||mm||95% Confidence Interval|Mean
701469|NCT00065806|Secondary|Change in Mean-Max CIMT|For each side, segment and wall, the maximum CIMT over the 4 angles of interrogation was selected to produce 12 summary variables (right common near wall max, right common far wall max, right bifurcation near wall max, right bifurcation far wall max, right internal near wall max, right internal far wall max, left common near wall max, left common far wall max, left bifurcation near wall max, left bifurcation far wall max, left internal near wall max and left internal far wall max). These 12 summary variables were then averaged to estimate a single mean-max CIMT for each participant visit.|Change from baseline to 36 months|||mm||95% Confidence Interval|Mean
701470|NCT00065806|Primary|Change in Mean-Mean Common Carotid IMT (CIMT)|For the common carotid arterial segment, mean CIMT values were averaged across angles by side and wall to produce 4 summary variables (right common near wall mean, right common far wall mean, left common near wall mean and left common far wall mean). These summary variables were then averaged to estimate a single mean-mean common CIMT for each participant visit.|Change from baseline to 36 months|||mm||95% Confidence Interval|Mean
701471|NCT00066066|Primary|Change in Mean Clinical Attachment Level.|Periodontal diseases are clinically diagnosed by assessments of gingival inflammation and measurements of tissue destruction. The damage to the apparatus of support of the teeth is quantified using measurements of probing pocket depth (PD) and clinical attachment level (CAL). These measurements are obtained using a periodontal probe which is introduced into the gingival sulcus to determine the distance in millimeters from the gingival margin to the depth of the sulcus or pocket (PD). Since the gingival margin fluctuates in response to inflammation (hyperplasia) or might recede, a more accurate measure of loss of attachment is obtained using the CAL, which measures the distance from a “fixed” landmark on the tooth such as the cemento-enamel junction to the depth of the pocket. Changes in CAL from baseline were used to assess results obtained with the treatment of periodontal diseases.|Baseline, 3, 6 and 12 months|Of the 146 subjects, 117 were included in the analysis, who had 2 or fewer missing monitoring visits. 84 subjects had complete data, 23 subjects had one missing visit and 10 subjects had 2 missing visits. For the 33 subjects with missing visits, data were carried forward. 68 subjects were non smokers and 49 subjects were current smokers.||mm||Standard Error|Mean
701472|NCT00066170|Primary|Daytime Sleep Latency as Measured by the Maintenance of Wakefulness Test (MWT)|The Maintenance of Wakefulness Test consisted of four 20 minute tests of the patient's ability to remain awake in soporific conditions. The Mean change from baseline to week 8 in the average MWT number of minutes until sleep onset was the primary endpoint.|Baseline to Week 8|||Minutes||Standard Deviation|Mean
701473|NCT00066222|Secondary|Response Rates (Complete Response, Partial Response, Progressive Disease and Stable Disease)||From the start of treatment to 2 months following the completion of chemotherapy||||||
701474|NCT00066222|Secondary|Rate of Treatment Related Fatalities at 2 Years||From the start of treatment to 2 years||||||
701475|NCT00066222|Secondary|Rate of Acute Treatment Related Grade 3 or 4 Esophagitis||From start of radiation therapy until 90 days following the start of radiation therapy||||||
701476|NCT00066222|Secondary|Progression-free Survival at 1 Year and Median Survival Time||From randomization to date of progression, death or last follow-up. Analysis occurs after all patients have been potentially followed for 1 year.||||||
701477|NCT00066222|Secondary|Overall Survival at 1 Year and Median Overall Survival||From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 1 year.||||||
701498|NCT00066690|Secondary|Overall Survival|Estimated percentage of patients alive and disease-free at 5 years from randomization, where overall survival is defined as the time from randomization to death from any cause; or censored at date last known alive.|5-year estimates||06/2017||||
701478|NCT00066222|Primary|Overall Survival at 2 Years|Survival time is defined as time from study registration to the date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. This analysis was planned to occur when all patients had been potentially followed for at least 2 years. This study was designed to detect an improvement in the 2-year overall survival rate from 47% to 60%. Using a one-group chi-square test with a one-sided significance level of 0.10, a sample of 67 patients was deemed sufficient to detect the difference between the null hypothesis (Ho: P .47) and the alternative hypothesis (Ha: P .60) with 80% power.|From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years.|All eligible patients who started study treatment.||percentage of participants||95% Confidence Interval|Number
701479|NCT00066365|Primary|Feasibility Success|Feasibility success defined as received 21 days of protocol therapy, did not experience grade III or grade IV toxicity according to Common Toxicity Criteria for Adverse Events (CTCAE) version 3 and rendered surgically free of disease in the lungs.|Enrollment through 21 days of protocol therapy|This outcome measure was calculated for eligible patients only. This yields 27 patients for assessment of this measure in Group 1 and 16 patients for assessment of this measure in Group 2.||participants|||Number
701480|NCT00066365|Primary|Event Free Survival (EFS)|EFS defined as the time from enrollment on the study until disease progression, occurrence of a second malignant neoplasm (SMN), death or last contact, whichever comes first. Disease progression, occurrence of a SMN or death will be considered an analytic even. In all other cases, the patient will be considered censored at last contact.|Time of enrollment to Event or 5 years from enrollment, whichever occurs first|There were 4 ineligible unilateral patients and 2 ineligible bilateral patients not included in this analysis.||years||95% Confidence Interval|Median
701481|NCT00066365|Primary|Clusterin Status in Post Chemotherapy Sample||29 days after start of protocol therapy|This outcome measure was evaluated in 30 patients, 20 patients in the unilateral recurrence group and 10 patients in bilateral recurrence group.||participants|||Number
701482|NCT00066365|Primary|Clusterin Status in Pre Chemotherapy Sample|The protein encoded by this gene can under some stress conditions also be found in the cell cytosol. It has been suggested to be involved in several basic biological events such as cell death, tumor progression, and neurodegenerative disorders.|29 days after start of protocol therapy|Patients enrolled in the unilateral recurrence group do not contribute to the assessment of any “Pre Chemotherapy” analysis. Such patients only had tissue for assessment after the first thoracotomy which was planned for 22 days after the start of sargramostim treatment. 7 patients were measured from the bilateral recurrence group.||participants|||Number
701483|NCT00066365|Primary|S100 Status in Post Chemotherapy Sample|"The S-100 proteins are a family of low-molecular-weight proteins characterized by two calcium-binding sites that have helix-loop-helix (EF-hand type) conformation."|29 days after start of protocol therapy|20 patients from the unilateral recurrence group and 10 patients from the bilateral recurrence group were evaluated for this outcome measure.||participants|||Number
701484|NCT00066365|Primary|S100 Status in Pre Chemotherapy Sample|"The S-100 proteins are a family of low-molecular-weight proteins characterized by two calcium-binding sites that have helix-loop-helix (EF-hand type) conformation."|29 days after start of protocol therapy|Patients enrolled in the unilateral recurrence group do not contribute to the assessment of any “Pre Chemotherapy” analysis. Such patients only had tissue for assessment after the first thoracotomy which was planned for 22 days after the start of sargramostim treatment. 7 patients were evaluated from the bilateral recurrence group.||participants|||Number
701485|NCT00066365|Primary|CD1a Status in Post Chemotherapy Sample|CD1a (Cluster of Differentiation 1a) is a human protein encoded by the CD1A gene, presence is measured by positivity.|29 days after start of protocol therapy|20 patients were evaluated for this outcome measure from the unilateral group and 7 patients were evaluated from the bilateral group.||participants|||Number
701486|NCT00066365|Primary|CD1a Status in Pre Chemotherapy Sample|CD1a (Cluster of Differentiation 1a) is a human protein encoded by the CD1A gene, presence is measured by positivity.|29 days after start of protocol therapy|Patients enrolled in the unilateral recurrence group do not contribute to the assessment of any “Pre Chemotherapy” analysis. Such patients only had tissue for assessment after the first thoracotomy which was planned for 22 days after the start of sargramostim treatment. 7 patients were evaluated from the bilateral recurrence group.||participants|||Number
701487|NCT00066365|Primary|FAS Status in Post Chemotherapy Sample|FAS/APO-1 is a transmembrane receptor. The presence is measured in Immunohistochemistry (IHC) categories.|29 days after start of protocol therapy|22 patients from the unilateral recurrence group and 13 patients from the bilateral recurrence group were evaluated for this outcome measure.||participants|||Number
701488|NCT00066365|Primary|FAS Ligand in Post Chemotherapy Sample|FAS ligand or FASL is a homotrimeric type II transmembrane protein expressed on cytotoxic T lymphocytes. The presence is measured in Immunohistochemistry (IHC) categories.|29 days after start of protocol therapy|22 patients from the unilateral recurrence group and 13 patients from the bilateral recurrence group were evaluated for this outcome measure.||participants|||Number
701489|NCT00066365|Primary|Presence of FAS in Pre-chemotherapy Sample|FAS/APO-1 is a transmembrane receptor. The presence is measured in Immunohistochemistry (IHC) categories.|29 days after start of protocol therapy|Patients who were enrolled in Group 1 (unilateral recurrence) do not contribute to the assessment of any “Pre Chemotherapy” analysis. Such patients only had tissue for assessment after the first thoracotomy which was planned for 22 days after the start of sargramostim treatment.||participants|||Number
701490|NCT00066365|Primary|Status of FAS Ligand in Pre-chemotherapy Sample|FAS ligand (FASL) is a homotrimeric type II transmembrane protein expressed on cytotoxic T lymphocytes. The Cluster of Differentiation 1a (CD1a) status is measured in Immunohistochemistry (IHC) categories.|29 days after start of protocol therapy|Patients who were enrolled in the unilateral recurrence group do not contribute to the assessment of any “Pre Chemotherapy” analysis. Such patients only had tissue for assessment after the first thoracotomy which was planned for 22 days after the start of sargramostim treatment. 14 patients were evaluated for this primary outcome measure.||participants|||Number
701491|NCT00066469|Primary|Event-free Survival|Alive in continuous complete remission with functioning original allograft. The Event Free Survival (EFS) will be estimated by the Kaplan-Meier method.|2 years|One patient out of the 55 patients enrolled was ineligible for study and therefore was excluded from analysis.||percentage of participants analyzed||95% Confidence Interval|Number
701499|NCT00066690|Secondary|Distant Recurrence-free Interval|Estimated percentage of patients alive and disease-free at 5 years from randomization, where distant recurrence-free Interval is defined as the time from randomization to invasive breast cancer recurrence at distant site, or invasive contralateral breast cancer; or censored at date of last follow up.|5-year estimates, reported at a median follow-up of 67 months.|Intention-to-treat||percentage of participants||95% Confidence Interval|Number
701500|NCT00066690|Secondary|Breast Cancer-free Interval|Estimated percentage of patients alive and disease-free at 5 years from randomization, where breast cancer-free interval is defined as the time from randomization to invasive breast cancer recurrence at local, regional, or distant site, or invasive contralateral breast cancer; or censored at date of last follow up.|5-year estimates, reported at a median follow-up of 67 months.|Intention-to-treat||percentage of participants||95% Confidence Interval|Number
701501|NCT00066690|Primary|Disease-free Survival|Estimated percentage of patients alive and disease-free at 5 years from randomization, where disease-free survival is defined as the time from randomization to the first appearance of one of the following: invasive breast cancer recurrence at local, regional, or distant site, invasive contralateral breast cancer, second (non-breast) invasive cancer, or death without cancer event; or censored at date of last follow-up.|5-year estimates, reported at a median follow-up of 67 months.|Intention-to-treat||percentage of participants||95% Confidence Interval|Number
701502|NCT00066703|Secondary|Overall Survival|Estimated percentage of patients alive and disease-free at 5 years from randomization, where overall survival is defined as the time from randomization to death from any cause; or censored at date last known alive.|5-year estimates||12/2017||||
701503|NCT00066703|Secondary|Distant Recurrence-free Interval|Estimated percentage of patients alive and disease-free at 5 years from randomization, where distant recurrence-free interval is defined as the time from randomization to breast cancer recurrence at a distant site; or censored at date of last follow-up|5-year estimates reported at a median follow-up of 72 months|Intention-to-treat||percentage of participants||95% Confidence Interval|Number
701504|NCT00066703|Secondary|Breast Cancer-free Interval|Estimated percentage of patients alive and disease-free at 5 years from randomization, where breast cancer-free interval is defined as the time from randomization to the invasive breast cancer recurrence at local, regional, or distant site, or invasive contralateral breast cancer; or censored at date of last follow up.|5-year estimate reported at a median follow-up of 72 months|Intention-to-treat||percentage of participants||95% Confidence Interval|Number
701505|NCT00066703|Primary|Disease-free Survival|Estimated percentage of patients alive and disease-free at 5 years from randomization, where disease-free survival is defined as the time from randomization to the first appearance of one of the following: invasive breast cancer recurrence at local, regional, or distant site, invasive contralateral breast cancer, second (non-breast) invasive cancer, or death without cancer event; or censored at date of last follow up.|5-year estimate reported at a median follow-up of 72 months|Intention-to-treat||percentage of participants||95% Confidence Interval|Number
701506|NCT00066742|Secondary|Progression-Free Survival|Progression was defined as a >= 20% increase in the sum of longest diameters of measurable lesions over the smallest sum observed or unequivocal progression of non-measurable disease or the appearance of any new lesion/site. Symptomatic deterioration was defined as a global deterioration of health status requiring discontinuation of treatment. Progression-free survival was defined as the time from the date of enrollment until the date of progression, symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free were censored at last contact date.|At end of concurrent chemoradiotherapy (Week 8), then at end of consolidation chemotherapy (Week 15). After off treatment, every 3 months for the first 2 years then every 6 months for up to 3 years after enrollment.|||months||95% Confidence Interval|Median
701507|NCT00066742|Secondary|Response Rate (Confirmed and Unconfirmed Complete and Partial Responses Per RECIST) in the Subset of Patients With Measurable Disease at Baseline.|A complete response (CR) was defined as a complete disappearance of all disease with no new lesions. A partial response (PR) was defined as at least a 30% decrease under baseline of the sum of longest diameters of all target measurable lesions with no unequivocal progression of non-measurable disease and no new lesions. Both CR and PR had to be confirmed by a second determination at least 4 weeks apart. All disease had to be assessed using same method as baseline. Only patients with measurable disease at baseline were included in this analysis.|After completeion of concurrent chemotherapy+radiation (Week 8); then after completion of consolidation chemotherapy (Week15); once off treatment, every 3 months until disease progression for a maximum of 3 years after enrollment.|Only eligible patients who received protocol treatment were included in the analysis.||participants|||Number
701508|NCT00066742|Primary|Overall Survival|Overall survival was defined as the time from date of enrollment until the date of death due to any cause. Patients last known to be alive were censored at the date of last conatct. Patients were followed for a maximum of 3 years from the date of enrollment.|Weekly during protocol treatment, then every 3 months for first year, then every 6 months for up to 3 years after enrollment.|Only eligible patients who received protocol treatment were included in the analsysis.||months||95% Confidence Interval|Median
701509|NCT00066781|Secondary|Time to Disease Progression|Time to disease progression is defined as the time from registration to documentation of disease progression. If a patient dies without a documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death. If the patient is declared to be a major treatment violation, the patient will be censored on the date the treatment violation was declared to have occurred. In the case of a patient starting treatment and then never returning for any evaluations, the patient will be censored for progression on day 1 post-registration. The distribution of time to progression will be estimated using the method of Kaplan-Meier. Time to disease progression will be calculated for all evaluable patients combined and by group (ie. for patients with or without the UGT1A1*28 polymorphism).|Up to 2 years|||Months||95% Confidence Interval|Median
701510|NCT00066781|Secondary|Overall Survival|Overall survival time is defined as the time from registration to death due > to any cause. The distribution of survival time will be estimated using > the method of Kaplan-Meier . Overall survival will be calculated for > all evaluable patients combined and by group (ie. for patients with or > without the UGT1A1*28 polymorphism).|Up to 2 years|||Months||95% Confidence Interval|Median
701511|NCT00066781|Primary|Confirmed Response Rate (Partial or Complete Response for 2 Consecutive Evaluations at Least 4 Weeks Apart) as Measured by RECIST Criteria|The primary endpoint is confirmed response rate. If measurable disease is present, a confirmed tumor response is defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart. All registered patients meeting the eligibility criteria that have signed a consent form and have begun treatment will be evaluable for response.|Up to 2 years|All evaluable patients||percentage of patients with response||95% Confidence Interval|Number
701512|NCT00066807|Secondary|Sites of First Treatment Failure||For first time at a median follow up approximately 5 years|The trial was terminated early due to poor accrual. No outcome measure data is available.|||||
701513|NCT00066807|Secondary|Systemic Disease-free Survival||For first time at a median follow up approximately 5 years|The trial was terminated early due to poor accrual. No outcome measure data is available.|||||
701514|NCT00066807|Secondary|Overall Survival||For first time at a median follow up approximately 5 years|The trial was terminated early due to poor accrual. No outcome measure data is available.|||||
701515|NCT00066807|Primary|Disease-free Survival||For first time at a median follow up approximately 5 years|The trial was terminated early due to poor accrual. No outcome measure data is available.|||||
701516|NCT00066937|Secondary|Mental Health as Assessed by the Short Form 36 Healthy Survey|The Mental Health Component score from the Short Form (36) Health Survey, which is a 36-item, patient-reported survey of patient health. The mental health component score is calculated from responses to the general health, mental health, vitality, physical and emotional role limitations, and social functioning subscales, with higher scores indicating better mental health. The scale ranges from zero (equivalent to maximum disability) to 100 (no disability).|baseline, post-treatment, 3 months, 6 months|||units on a scale||Standard Deviation|Mean
701517|NCT00066937|Secondary|Worst Pain|0 (no pain) to 10 (pain as bad as could be) rating of worst pain during the past week|baseline, post-treatment, 3 months, 6 months|||units on a scale||Standard Deviation|Mean
701518|NCT00066937|Primary|Change in Pain-related Interference|Multidimensional Pain Inventory: Pain interference subscale score; average score computed from 12 items rated on scale from 0=no interference to 6=extreme interference; higher scores indicate greater pain-related interference|baseline, post-treatment, 3 months, 6 months|||Change in scores on a scale||Standard Deviation|Mean
701519|NCT00066937|Primary|Average Pain|0 (no pain) to 10 (pain as bad as could be) rating of average pain during the past week; higher scores indicate greater pain|baseline, post-treatment, 3 months, 6 months|||units on a scale||Standard Deviation|Mean
701520|NCT00066963|Primary|Number of Caries Incident Cases|A trained, calibrated dentist blinded to treatment arm performed visual-tactile dental exams at 1 and 2 years post-baseline. Group-specific number of incident cases were reported as the number of individual participants with caries at a follow-up visit.|two years|intention-to-treat with any follow-up information. multiple imputation for sensitivity analyses.||participants|||Number
701521|NCT00067236|Primary|Change From Baseline in Left Ventricular End Diastolic Volume Index (LVEDVi in mL/m2) at Day 90 Post Myocardial Infarction (MI)|Mean change of left ventricular end diastolic volume index (mL/m2) as evaluated via ventricular end-diastolic volume index augmentation 90 days post Myocardial Infarction (MI)|90 days|A patient was considered evaluable for the primary efficacy assessment if data were complete for at least the baseline and Day 90 visit (i.e., no data were imputed for the primary endpoint).||mL/m2||Standard Error|Mean
701522|NCT00067470|Secondary|Change From Baseline in Urinary GAG (uGAG) at 24 Weeks|Glycosaminoglycan (GAG) level measured in urine|baseline and 24 weeks|Baseline uGAG level was measured for 19 rhASB-treated subjects and 20 placebo-treated subjects. However, uGAG levels at 24 weeks were measured for 19 rhASB-treated subjects and 19 placebo-treated subjects, because 1 placebo-treated subject withdrew from the study before week 24.||micrograms per mg creatinine||Standard Deviation|Mean
701523|NCT00067470|Secondary|Change From Baseline in 3-minute Stair Climb at 24 Weeks|Number of stairs climbed per minute in 3 minutes at 24 weeks minus number of stairs climbed per minute in 3 minutes at baseline|baseline and 24 weeks|The efficacy analysis included all subjects except one from the placbo group who withdrew from the study prior to the week 24 assessment.||stairs/min||Standard Deviation|Mean
701524|NCT00067470|Primary|Change From Baseline in 12-minute Walk Test at 24 Weeks|Number of meters walked in 12 minutes at week 24 minus number of meters walked in 12 minutes at baseline|baseline and 24 weeks|The efficacy analysis included all subjects except one from the placebo group who withdrew from the study prior to the week 24 assessment.||meters||Standard Deviation|Mean
701525|NCT00053846|Primary|Dyspnea as Measured by Oxygen Cost Diagram (OCD)|OCD was used to evaluate dyspnea on exertion and activities of daily living. OCD is a visual analog scale for quantifying a patient's evaluation of tolerance of exertion, which corresponds to oxygen requirements at different activity levels. It is measured as a score of 2 (sleeping) to 14 (brisk walking uphill). HIgher scores indicate fewer limitations due to dyspnea.|28 days after beginning study drug or placebo|||units on a scale||Standard Deviation|Mean
701526|NCT00054028|Secondary|Response as Measured by RECIST Criteria|Evaluation of secondary endpoints will be primarily descriptive. Descriptive data will be computed and compared using analysis of variance and non-parametric rank equivalents for continuous data and chi-square or Fisher's exact test for discrete data. Response rates will include 95% confidence limits.|Up to 5 years|Objective Response Rate||percentage of patients|||Number
701527|NCT00054028|Primary|Objective Response Rate (Complete Response and Partial Response) as Measured by RECIST Criteria (Phase II)|Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.0) for target lesion s and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR+PR.|Up to 8 weeks|||patients|||Number
701528|NCT00054028|Primary|Percentage of Patients That Achieved Target Suramin Concentrations in Plasma|Target suramin concentration was considered achieved, if at least 5 of 6 patients achieved the target plasma concentration of 10-50 µM over the duration of 8-48 hours when paclitaxel levels are therapeutic.|Up to 5 years|||percent of patients|||Number
701529|NCT00054132|Other Pre-specified|Percentage of Cells Staining Positive for VEGFR-2|Associations between markers and tumor response will be assessed by logistic regression analysis. For those markers that are statistically significant, a cut-point analysis will be performed by the maximum chi-square with p-value adjustment method to determine positive values.|Up to 12 years||||||
701534|NCT00054132|Other Pre-specified|Percentage of Cells Staining Positive for Phosphorylated-mitogen-activated Protein Kinase (MAP) Kinase|Associations between markers and tumor response will be assessed by logistic regression analysis. For those markers that are statistically significant, a cut-point analysis will be performed by the maximum chi-square with p-value adjustment method to determine positive values.|Up to 12 years||||||
701535|NCT00054132|Other Pre-specified|Percentage of Cells Staining Positive for p27|Associations between markers and tumor response will be assessed by logistic regression analysis. For those markers that are statistically significant, a cut-point analysis will be performed by the maximum chi-square with p-value adjustment method to determine positive values.|Up to 12 years||||||
701536|NCT00054132|Other Pre-specified|Percentage of Cells Staining Positive for Marker of Proliferation Ki-67 (Ki-67)|Associations between markers and tumor response will be assessed by logistic regression analysis. For those markers that are statistically significant, a cut-point analysis will be performed by the maximum chi-square with p-value adjustment method to determine positive values.|Up to 12 years||||||
701537|NCT00054132|Other Pre-specified|Percentage of Cells Staining Positive for Human Epidermal Growth Factor Receptor 3 (HER3)|Associations between markers and tumor response will be assessed by logistic regression analysis. For those markers that are statistically significant, a cut-point analysis will be performed by the maximum chi-square with p-value adjustment method to determine positive values.|Up to 12 years||||||
701538|NCT00054132|Other Pre-specified|Percentage of Cells Staining Positive for EGFR|Associations between markers and tumor response will be assessed by logistic regression analysis. For those markers that are statistically significant, a cut-point analysis will be performed by the maximum chi-square with p-value adjustment method to determine positive values.|Up to 12 years||||||
701539|NCT00054132|Other Pre-specified|HER2 Status|Associations between response and HER2 will be assessed by Fisher's exact test.|Up to 12 years||||||
701540|NCT00054132|Secondary|Participants With Duration of Stable Disease Greater Than or Equal to 6 Months|Duration of stable disease greater than or equal to 6 months|From the start of treatment until the first date that recurrent or progressive disease is objectively documented, assessed up to 12 years|||Participants|||Count of Participants
701541|NCT00054132|Secondary|Number of Patients Evaluated for Toxicity|graded according to the National Cancer Institute Common Toxicity Criteria version 4.0|up to 12 years|Please see adverse events section.||Participants|||Count of Participants
701542|NCT00054132|Secondary|Time to Progression|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|From the start of treatment until the first date that recurrent or progressive disease is objectively documented, assessed up to 12 years|||weeks||95% Confidence Interval|Median
701543|NCT00054132|Secondary|Duration of Response|The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started).Evaluation of Target Lesions Complete Response (CR):Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD|From the time measurement criteria are met for CR and PR until the first date that recurrent or progressive disease is objectively documented, assessed up to 12 years|||months|||Number
701544|NCT00054132|Primary|Response Rate, Defined as Complete Response (CR) + Partial Response (PR), Using the Response Evaluation Criteria in Solid Tumors|Estimated at the end of the trial. Complete Response (CR):Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD 55 Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started|Up to 12 years|||participants|||Number
701545|NCT00054132|Primary|Level of EGFR Expression|"Estimated at the end of the trial Immunoreactivity will be evaluated qualitatively with regard to intensity as follows: Measured on a scale, ranging from 0-3+ 0=negative (no immunoreactivity)
1+ - 3+ = positive:
faint immunoreactivity (weak staining)
intense immunoreactivity (strong staining) Immunohistochemical studies will be performed on the tumor specimen to correlate the anti-tumor efficacy of OSI-774 and bevacizumab with pre-treatment molecular characteristics."|Up to 12 years|||participants|||Number
701546|NCT00054275|Secondary|Overall Survival as of 2008|Overall survival (OS) was defined as time from the start of treatment to death, and censored at the time of last assessment for survivors.|5 yrs|Including 10 patients with only 1 cycle of treatment||months||95% Confidence Interval|Median
701547|NCT00054275|Secondary|Progression Free Survival(PFS)|Progression free survival was defined as time from the start of treatment to the date of cancer progression, or death, and censored at the date of last follow-up for those without disease progression and still alive. Stable disease is measured from the start of the treatment until progression, taking as reference the smallest measurements recorded since the treatment started. Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|3 years|||months||95% Confidence Interval|Median
701548|NCT00054275|Primary|Disease Response (Tumor Measurements)Per RECIST Criteria v. 2000|Response and progression will be evaluated in this study using the criteria by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria. Partial Response: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions. Progressive Disease: At least a 20% increase in the sum of the LD of target lesions. Stable Disease: Neither sufficient shrinkage nor sufficient increase.|after 6 course (6 months) of combination therapy|Excluding 11 not evaluable cases||participants|||Number
701549|NCT00054327|Post-Hoc|Number of Patients With Overall Survival at 2 Years.||at 2 years from transplant|||participants|||Number
701550|NCT00054327|Secondary|Toxicity as Measured by CTC v2.0|Number of patients that experience grade 3 or above toxicity. See serious adverse event list for toxicities.|at 100 days post transplant|||participants|||Number
701556|NCT00054665|Primary|Clinical Response Rate|Clinical Response Rate is the number of participants with a partial and complete response assessed by the criteria for lymphoma. A complete response is complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy and normalization of those biochemical abnormalities. Partial response is a greater than or equal to 50% decrease in the sum of the products of the greatest diameters of 6 largest dominant nodes or nodal masses. No increase in size of nodes, liver or spleen and no new sites of disease|18 weeks|||Participants|||Number
701557|NCT00054691|Secondary|Duration of Response|Response duration was defined as the time from initial response during therapy to progression of disease.|Every 8 weeks till disease progression.|Out of 40 participants, 19 participants had progressive disease, 2 participants had unmeasurable disease and 1 participant was noncompliant.||months||Full Range|Median
701558|NCT00054691|Primary|Number of Participants With Objective Response (Partial Response, Stable Disease and Progressive Disease)|Responses were assessed according to the Union Internationale Contre le Cancer (UICC) / World Health Organization (WHO) criteria. Objective response (measurable response) defined as: Partial response (PR): Applies only to participants with at least 1 measurable lesion; >/=50% decrease under baseline in sum of products of perpendicular diameters of all measurable lesions. Stable Disease (SD): No progression of evaluable disease and/or no new lesions. Progressive Disease (PD): 50% increase or an increase of 10 cm2 (whichever is smaller) in the sum of products of all measurable lesions overall smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease.|Every 8 weeks till disease progression.|Out of 40 participants, 2 participants had unmeasurable disease and 1 participant was noncompliant.||participants|||Number
701559|NCT00054704|Primary|Montgomery-Asberg Depression Rating Scale|The Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician-rated assessment of depression symptoms. Patients were rated weekly on 10 symptoms on a scale of 0 to 6 for each item, where 0 indicated no symptoms and 6 indicated the highest severity of that symptom. Total scores range from 0 to 60, where a moderate severity of depression would be present with a score of at least 20.|8 weeks|Data from all patients were included in the analysis.||Units on a scale||Standard Error|Least Squares Mean
701560|NCT00054717|Secondary|Percentage of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 Laboratory Abnormalities|NIH Division of Acquired Immunodeficiency Syndrome (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|240 Weeks|Safety Analysis Set with On-Treatment data (SAF-OT), all patients treated with at least one dose of study drug and have on-treatment laboratory values||Percentage of participants|||Number
701561|NCT00054717|Secondary|Virologic Response (VL < 50 Copies/ml) at Week 96|Percentage of participants with Viral Load < 50 copies/mL|Week 96|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
701562|NCT00054717|Secondary|Virologic Response (VL < 50 Copies/ml) at Week 88|Percentage of participants with Viral Load < 50 copies/mL|Week 88|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
701563|NCT00054717|Secondary|Virologic Response (VL < 50 Copies/ml) at Week 80|Percentage of participants with Viral Load < 50 copies/mL|Week 80|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
701564|NCT00054717|Secondary|Virologic Response (VL < 50 Copies/ml) at Week 72|Percentage of participants with Viral Load < 50 copies/mL|Week 72|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
701565|NCT00054717|Secondary|Virologic Response (VL < 50 Copies/ml) at Week 64|Percentage of participants with Viral Load < 50 copies/mL|Week 64|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
701566|NCT00054717|Secondary|Virologic Response (VL < 50 Copies/ml) at Week 56|Percentage of participants with Viral Load < 50 copies/mL|Week 56|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
701567|NCT00054717|Secondary|Virologic Response (VL < 50 Copies/ml) at Week 48|Percentage of participants with Viral Load < 50 copies/mL|Week 48|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
701568|NCT00054717|Secondary|Virologic Response (VL < 50 Copies/ml) at Week 40|Percentage of participants with Viral Load < 50 copies/mL|Week 40|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
701569|NCT00054717|Secondary|Virologic Response (VL < 50 Copies/ml) at Week 32|Percentage of participants with Viral Load < 50 copies/mL|Week 32|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
701570|NCT00054717|Secondary|Virologic Response (VL < 50 Copies/ml) at Week 24|Percentage of participants with Viral Load < 50 copies/mL|Week 24|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
701571|NCT00054717|Secondary|Virologic Response (VL < 50 Copies/ml) at Week 16|Percentage of participants with Viral Load < 50 copies/mL|Week 16|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
701572|NCT00054717|Secondary|Virologic Response (VL < 50 Copies/ml) at Week 8|Percentage of participants with Viral Load < 50 copies/mL|Week 8|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
701573|NCT00054717|Secondary|Virologic Response (VL < 50 Copies/ml) at Week 4|Percentage of participants with Viral Load < 50 copies/mL|Week 4|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
701574|NCT00054717|Secondary|Virologic Response (VL < 50 Copies/ml) at Week 2|Percentage of participants with Viral Load < 50 copies/mL|Week 2|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
701575|NCT00054717|Secondary|Virologic Response (VL < 50 Copies/ml) at Viral Load Nadir, LOCF|Percentage of participants with Viral Load < 50 copies/mL|Week 2 through Week 96 (at any point during trial)|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
701587|NCT00054717|Secondary|Virologic Response (VL < 400 Copies/ml) at Week 8|Percentage of participants with Viral Load < 400 copies/mL|Week 8|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
701588|NCT00054717|Secondary|Virologic Response (VL < 400 Copies/ml) at Week 4|Percentage of participants with Viral Load < 400 copies/mL|Week 4|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
701589|NCT00054717|Secondary|Virologic Response (VL < 400 Copies/ml) at Week 2|Percentage of participants with Viral Load < 400 copies/mL|Week 2|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
701590|NCT00054717|Secondary|Virologic Response (VL < 400 Copies/ml) at Viral Load Nadir, LOCF|Percentage of participants with Viral Load < 400 copies/mL|Week 2 through Week 96 (at any point during trial)|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
701591|NCT00054717|Secondary|Time to New CDC Class C Progression Event or Death.|Time to new Centers for Disease Control and Prevention (CDC) class C progression event (i.e., new AIDS defining illness) or death|after 48 weeks of treatment|Safety Analysis Set (SAF), includes all patients treated with at least one dose of study medication||Days||Inter-Quartile Range|Median
701592|NCT00054717|Secondary|Mean Change From Baseline to Week 96 in CD4+ Cell Count||Baseline to Week 96|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Cells/mm3||Standard Deviation|Mean
701593|NCT00054717|Secondary|Mean Change From Baseline to Week 88 in CD4+ Cell Count||Baseline to Week 88|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Cells/mm3||Standard Deviation|Mean
701594|NCT00054717|Secondary|Mean Change From Baseline to Week 80 in CD4+ Cell Count||Baseline to Week 80|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Cells/mm3||Standard Deviation|Mean
701595|NCT00054717|Secondary|Mean Change From Baseline to Week 72 in CD4+ Cell Count||Baseline to Week 72|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Cells/mm3||Standard Deviation|Mean
701596|NCT00054717|Secondary|Mean Change From Baseline to Week 64 in CD4+ Cell Count||Baseline to Week 64|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Cells/mm3||Standard Deviation|Mean
701597|NCT00054717|Secondary|Mean Change From Baseline to Week 56 in CD4+ Cell Count||Baseline to Week 56|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Cells/mm3||Standard Deviation|Mean
701598|NCT00054717|Secondary|Mean Change From Baseline to Week 48 in CD4+ Cell Count||Baseline to Week 48|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Cells/mm3||Standard Deviation|Mean
701599|NCT00054717|Secondary|Mean Change From Baseline to Week 40 in CD4+ Cell Count||Baseline to Week 40|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Cells/mm3||Standard Deviation|Mean
701600|NCT00054717|Secondary|Mean Change From Baseline to Week 32 in CD4+ Cell Count||Baseline to Week 32|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Cells/mm3||Standard Deviation|Mean
701601|NCT00054717|Secondary|Mean Change From Baseline to Week 24 in CD4+ Cell Count||Baseline to Week 24|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Cells/mm3||Standard Deviation|Mean
701602|NCT00054717|Secondary|Mean Change From Baseline to Week 16 in CD4+ Cell Count||Baseline to Week 16|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Cells/mm3||Standard Deviation|Mean
701603|NCT00054717|Secondary|Mean Change From Baseline to Week 8 in CD4+ Cell Count||Baseline to Week 8|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Cells/mm3||Standard Deviation|Mean
701604|NCT00054717|Secondary|Mean Change From Baseline to Week 4 in CD4+ Cell Count||Baseline to Week 4|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Cells/mm3||Standard Deviation|Mean
701605|NCT00054717|Secondary|Mean Change From Baseline to Week 2 in CD4+ Cell Count||Baseline to Week 2|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Cells/mm3||Standard Deviation|Mean
701606|NCT00054717|Secondary|Median Change From Baseline in Viral Load to Week 96||Baseline to Week 96|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Log(Copies/mL)||Inter-Quartile Range|Median
701607|NCT00054717|Secondary|Median Change From Baseline in Viral Load to Week 88||Baseline to Week 88|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Log(Copies/mL)||Inter-Quartile Range|Median
701608|NCT00054717|Secondary|Median Change From Baseline in Viral Load to Week 80||Baseline to Week 80|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Log(Copies/mL)||Inter-Quartile Range|Median
701609|NCT00054717|Secondary|Median Change From Baseline in Viral Load to Week 72||Baseline to Week 72|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Log(Copies/mL)||Inter-Quartile Range|Median
701610|NCT00054717|Secondary|Median Change From Baseline in Viral Load to Week 64||Baseline to Week 64|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Log(Copies/mL)||Inter-Quartile Range|Median
701611|NCT00054717|Secondary|Median Change From Baseline in Viral Load to Week 56||Baseline to Week 56|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Log(Copies/mL)||Inter-Quartile Range|Median
701612|NCT00054717|Secondary|Median Change From Baseline in Viral Load to Week 48||Baseline to Week 48|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Log(Copies/mL)||Inter-Quartile Range|Median
701613|NCT00054717|Secondary|Median Change From Baseline in Viral Load to Week 40||Baseline to Week 40|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Log(Copies/mL)||Inter-Quartile Range|Median
701614|NCT00054717|Secondary|Median Change From Baseline in Viral Load to Week 32||Baseline to Week 32|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Log(Copies/mL)||Inter-Quartile Range|Median
701620|NCT00054717|Secondary|Virologic Response (Viral Load >= 1 Log Drop) at Week 64|Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline|Week 64|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
701621|NCT00054717|Secondary|Virologic Response (Viral Load >= 1 Log Drop) at Week 56|Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline|Week 56|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
701622|NCT00054717|Secondary|Virologic Response (Viral Load >= 1 Log Drop) at Week 48|Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline|Week 48|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
701623|NCT00054717|Secondary|Virologic Response (Viral Load >= 1 Log Drop) at Week 40|Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline|Week 40|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
701624|NCT00054717|Secondary|Virologic Response (Viral Load >= 1 Log Drop) at Week 32|Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline|Week 32|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
701625|NCT00054717|Secondary|Virologic Response (Viral Load >= 1 Log Drop) at Week 24|Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline|Week 24|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
701626|NCT00054717|Secondary|Virologic Response (Viral Load >= 1 Log Drop) at Week 16|Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline|Week 16|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
701627|NCT00054717|Secondary|Virologic Response (Viral Load >= 1 Log Drop) at Week 8|Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline|Week 8|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
701628|NCT00054717|Secondary|Virologic Response (Viral Load >= 1 Log Drop) at Week 4|Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline|Week 4|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
701629|NCT00054717|Secondary|Virologic Response (Viral Load >= 1 Log Drop) at Week 2|Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline|Week 2|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
701630|NCT00054717|Secondary|Virologic Response (Viral Load >= 1 Log Drop) at Viral Load Nadir, LOCF|Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline|Week 2 through Week 96 (at any point during trial)|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
701631|NCT00054717|Secondary|Time to Confirmed Virologic Failure Through 96 Weeks of Treatment|Time to virologic failure is defined as the time from the start of treatment to the last measurement with a viral load reduction greater than 1.0 log before a confirmed drop of viral load reduction below 1.0 log.|Week 96|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Days||Inter-Quartile Range|Median
701632|NCT00054717|Secondary|Time to Confirmed Virologic Failure Through 48 Weeks of Treatment|Time to virologic failure is defined as the time from the start of treatment to the last measurement with a viral load reduction greater than 1.0 log before a confirmed drop of viral load reduction below 1.0 log.|Week 48|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Days||Inter-Quartile Range|Median
701633|NCT00054717|Secondary|Time to Treatment Failure Through 96 Weeks of Treatment|time to treatment failure is defined as 0 for patients who never achieve TR otherwise time to treatment failure is the earliest time of death, discontinuation of the study drug or introduction of a new anti-retroviral drug to the regimen if it is not solely related to either toxicity or intolerance clearly attributable to a background, or the first of two consecutive visits with VL measurements <1 log10 below baseline.|Week 96|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Days||Inter-Quartile Range|Median
701634|NCT00054717|Secondary|Treatment Response at Week 96|Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|Week 96|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||percentage of participants|||Number
701635|NCT00054717|Secondary|Treatment Response at Week 88|Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|Week 88|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||percentage of participants|||Number
701636|NCT00054717|Secondary|Treatment Response at Week 80|Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|Week 80|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||percentage of participants|||Number
701637|NCT00054717|Secondary|Treatment Response at Week 72|Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|Week 72|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||percentage of participants|||Number
701638|NCT00054717|Secondary|Treatment Response at Week 64|Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 64|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||percentage of participants|||Number
701639|NCT00054717|Secondary|Treatment Response at Week 56|Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 56|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||percentage of participants|||Number
701640|NCT00054717|Secondary|Treatment Response at Week 48|Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|Week 48|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||percentage of participants|||Number
701641|NCT00054717|Secondary|Treatment Response at Week 40|Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|Week 40|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||percentage of participants|||Number
701642|NCT00054717|Secondary|Treatment Response at Week 32|Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|Week 32|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||percentage of participants|||Number
701643|NCT00054717|Secondary|Treatment Response at Week 24|Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 24|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||percentage of participants|||Number
701644|NCT00054717|Secondary|Treatment Response at Week 16|Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 16|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||percentage of participants|||Number
701645|NCT00054717|Secondary|Treatment Response at Week 8|Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 8|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
701646|NCT00054717|Secondary|Treatment Response at Week 4|Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 4|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||percentage of participants|||Number
701647|NCT00054717|Secondary|Treatment Response at Week 2|Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 2|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||percentage of participants|||Number
701648|NCT00054717|Secondary|Treatment Response at Week 24|Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|Week 24|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||percentage of participants|||Number
701649|NCT00054717|Primary|Time to Treatment Failure Through 48 Weeks of Treatment|Time to treatment failure is defined as 0 for patients who never achieve TR otherwise time to treatment failure is the earliest time of death, discontinuation of the study drug or introduction of a new anti-retroviral drug to the regimen if it is not solely related to either toxicity or intolerance clearly attributable to a background, or the first of two consecutive visits with VL measurements <1 log10 below baseline.|Week 48|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Days||Inter-Quartile Range|Median
701650|NCT00054717|Primary|Treatment Response at Week 48|Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|At week 48|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||percentage of participants|||Number
701651|NCT00054847|Secondary|Stroke||Within 1 year of bypass surgery|||participants|||Number
701652|NCT00054847|Secondary|Myocardial Infarction||Within 1 year of bypass surgery|||participants|||Number
701653|NCT00054847|Secondary|Death||Within 1 year of surgery.|||participants|||Number
701654|NCT00054847|Primary|To Compare 1-year Angiographic Patency of Radial Artery Grafts Versus Saphenous Vein Grafts in Patients Undergoing Elective Coronary Artery Bypass Graft (CABG) Surgery.|The primary end point was angiographic graft patency at 1 year after coronary artery bypass surgery, defined as any opacification of distal target by injection of the graft. The window for the 1-year angiogram was 2 to 24 months. This window was chosen to capture early clinically indicated angiograms and late selective angiograms in patients who did not have symptoms. Study grafts that were occluded at 1 week after coronary artery bypass graft surgery were considered occluded at 1 year. One-year graft patency data were missing if patients whose study grafts were patent at 1 week did not undergo an angiogram within the time window or if the central angiography laboratory was not able to determine graft patency.|1 year|All analyses were performed according to intention to treat. The study was designed to have 90%power to detect 1-year patency rates of 92% in radial artery vs 83% in saphenous vein grafts, with a 2-sided type I error of 5% and an expected 1-year catheterization completion rate of 65%. .||grafts|Participants||Number
701655|NCT00061373|Secondary|Bleeding Events|Bleeding events of any type, severity and at any time throughout the 30-day trial period.|2 hr, 24 hr, 72 hr, 5 days, 30 days from start of study drugs|All bleeding events that occurred among all patients enrolled and throughout the 30-day trial period but not classified as a primary outcome event. Bleeding events in this category include asymptomatic ICH(aICH);major systemic bleeding after 72 hours or minor and non-significant bleeding at anytime within the 30-day period.||participants|||Number
701668|NCT00069641|Secondary|Change From Baseline in Mean Global Joint Range of Motion (JROM) Score at Week 53|Change was calculated at Week 53 from baseline. Global JROM (% of normal range of motion) is the average of 11 ratios multiplied by 100. Ratios are Left/Right means of passive range of motion in Shoulder (Flexion/Extension, Abduction, Internal/External Rotation), Elbow (Flexion/Extension), Wrist (Flexion/Extension), Index Finger (Flexion/Extension [Combined Metacarpophalangeal joint (MCP), Proximal interphalangeal joint (PIP), Distal interphalangeal joint (DIP) motion]), Hip (Flexion/Extension, Abduction, Internal/External Rotation), Knee (Flexion/Extension), and Ankle (Dorsiflexion) divided by the normal range (American Academy of Orthopedic Surgeons and American Medical Association).|Baseline, Week 53|ITT population. Here, number of participants analyzed = participants who were evaluable for this measure.||percentage of normal range of motion||Standard Error|Mean
701656|NCT00061373|Primary|Non-MRI Selected Arm: Substantial Clinical Recovery (Non-MRI Arm)|"This is the primary response outcome measure for subjects in the non-MRI arm. A positive response is measured by a 7 point or more improvement in the NIHSS or for those with less than 7 points at baseline,complete resolution of stroke symptoms.
The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute stroke on the levels of consciousness, language, neglect, visual-field loss, extra ocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patient's ability to answer questions and perform activities. Ratings for each of the 15 items are scored. Patients who have a score of 0 are considered to have normal examination. Patients with a score of 40 have the most severe stroke symptoms."|up to 24 hours from the start of study drugs|Clinical improvement on NIHSS of 7 points or greater at 72 hours is the primary response outcome for non-MRI selected patients. Clinical response outcome was analyzed on all patients enrolled; MRI selected and non-selected patients.||participants|||Number
701657|NCT00061373|Primary|MRI Selected Arm: Complete Brain Reperfusion|This is the primary response outcome measure for patients in the MRI arm. A positive response is measured by evidence of complete reperfusion (or restoration of blood flow)on the perfusion weighted images (PWI) and mean transit time (MTT) maps of MRIs at 2 hours and sustained at 24 hours.|up to 24 hours from the start of study drugs|Complete reperfusion at 2 and 24 hours was measured in MRI-selected patients only.||participants|||Number
701658|NCT00061373|Primary|Other Serious Adverse Event Related to Study Drug Administration, Including Death.|This is a primary safety outcome for all subjects.|From start of study drugs and prior to 72-hour head CT|All Patients completed 72-hour study safety evaluation||participants|||Number
701659|NCT00061373|Primary|Major Systemic Hemorrhage|Major systemic hemorrhage is defined bleeding associated with an adjusted decrease in hemoglobin of greater than 5 grams per diluent (g/dL), or and adjusted decrease in hematocrit greater than or equal to 15 percentage points or bleeding causing persistent or significant disability or incapacity such as hemorrhage in the eye.|From the start of study drugs and prior to 72-hour head CT|All patients completed 72-hour safety evaluation||participants|||Number
701660|NCT00061373|Primary|Symptomatic Intracerebral Hemorrhage (ICH)|"This is a primary safety outcome or toxicity measure for all subjects.
Symptomatic ICH is defined as the presence of two conditions: evidence of hemorrhage on the 72-hour head CT and an increase in the NIHSS score of 4 or more points from the prior examination. Hemorrhage classifications are according to European Cooperative Acute Stroke Study (ECASS).
The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute stroke on the levels of consciousness, language, neglect, visual-field loss, extra ocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patient's ability to answer questions and perform activities. Ratings for each of the 15 items are scored. Patients who have a score of 0 are considered to have normal examination. Patients with a score of 40 have the most severe stroke symptoms."|From the start of study drugs and prior to the 72-hour safety head CT|All patients had a 72-hour safety head CT performed||participants|||Number
701661|NCT00067808|Primary|Participant Responses|Objective responses by International Working Group criteria: 'Complete Response' (CR) defined as Normalization of the peripheral blood and bone marrow with <5% bone marrow blasts, a peripheral blood granulocyte count > (1.0 x 109/ L, and a platelet count > 100 x 109/L); 'Other Response' including Partial Remission (PR) defined as above, except for the presence of 6-15% marrow blasts, or 50% reduction if <15% at start of treatment combined with participants who meet all criteria for CR except for platelet recovery to >100 x 109/L; and 'No Response'.|Response to treatment after 8 weeks of therapy|As treated: 124 patients completed treatment.||Participants|||Number
701662|NCT00069641|Secondary|Percent Change From Baseline in Mean Cardiac Left Ventricular Mass Index (LVMI) at Week 53|Cardiac LVMI was determined by echocardiography. Change was calculated at Week 53 from baseline. LVMI is the LVM, in grams indexed to BSA, in square meter [m^2]. LVMI in g/m^2 = LVM divided by BSA.|Baseline, Week 53|ITT population. Here, number of participants analyzed = participants who were evaluable for this measure.||percent change||Standard Error|Mean
701663|NCT00069641|Secondary|Mean Cardiac Left Ventricular Mass Index (LVMI) at Baseline|Cardiac LVMI was determined by echocardiography. LVMI is the left ventricular mass (LVM, in grams [g]) indexed to body surface area (BSA), in square meter [m^2]. LVMI (in gram per square meter [g/m^2]) = LVM divided by BSA.|Baseline|ITT population. Here, number of participants analyzed = participants who were evaluable for this measure.||gram per square meter (g/m^2)||Standard Error|Mean
701664|NCT00069641|Primary|Ranked Adjusted 2-Component Composite Variable Score Based on Change From Baseline to Week 53|The 2-component composite variable consists of the sum of the ranked changes from baseline to Week 53 for percent predicted Forced Vital Capacity (FVC) and 6-Minute Walking Test (6MWT) total distance walked. For the 2 treatment groups being compared, ranking occurred within the comparison treatment groups combined (idursulfase weekly and placebo treatment groups). These comparison groups were pooled and ranked for each component separately. Within each component (% predicted FVC, 6MWT), the change from baseline was then ranked. The lowest change value was assigned a rank of 1, the next lowest a rank of 2, etc. The composite score for each participant was the sum of the 2 ranked scores corresponding to the 2 individual components (% predicted FVC and 6MWT) for each participant. Thus, the greater the composite score (greater the sum of the ranks of the changes from baseline, where the lowest change was ranked as 1), the greater the improvement.|Baseline, Week 53|Intent-to-treat (ITT) population, Only participants receiving “Idursulfase Weekly” or “Placebo” were to be analyzed for this outcome.||sum of the ranked scores||Standard Error|Mean
701665|NCT00069641|Secondary|Change From Baseline in Mean Normalized Urine Glycosaminoglycan (GAG) Levels at Week 53|Mean normalized urine GAG was analyzed using urine testing. Change was calculated at Week 53 from baseline. The urine GAG levels were normalized to urine creatinine and were reported as microgram GAG per milligram creatinine (mcg GAG/mg creatinine).|Baseline, Week 53|ITT population.||mcg GAG/mg creatinine||Standard Error|Mean
701666|NCT00069641|Secondary|Percent Change From Baseline in Mean Combined Liver and Spleen Volume at Week 53|Liver and Spleen volume was determined by Magnetic Resonance Imaging (MRI). Change was calculated at Week 53 from baseline.|Baseline, Week 53|ITT population. Here, number of participants analyzed = participants who were evaluable for this measure.||percent change||Standard Error|Mean
701667|NCT00069641|Secondary|Mean Combined Liver and Spleen Volume at Baseline|Liver and Spleen volume was determined by Magnetic Resonance Imaging (MRI).|Baseline|ITT population. Here, number of participants analyzed = participants who were evaluable for this measure.||milliliter (mL)||Standard Error|Mean
701669|NCT00069784|Other Pre-specified|Number of Patients With First Occurrence of Any Type of Cancer|Data on cancers that occurred in association with hospitalizations were collected systematically in both groups from the start of the study. All reported cancers occurring during the trial (new or recurrent) were adjudicated by the Event Adjudication Committee.|from randomization until study cut-off date (median duration of follow-up: 6.2 years)|The analysis was based on the intent-to-treat (ITT) population.||participants|||Number
701670|NCT00069784|Other Pre-specified|Number of Patients With Various Types of Symptomatic Hypoglycemia Events|"Symptomatic hypoglycemia was defined as an event with clinical symptoms consistent with hypoglycemia, based on data recorded in the participant’s diary. These were further categorized as confirmed (ie, with a concomitant home glucose reading ≤54 mg/dL [≤3.0 mmol/L]) or unconfirmed.
Severe hypoglycemia was defined as an event with clinical symptoms consistent with hypoglycemia in which the participant required the assistance of another person, and one of the following:
the event was associated with a documented self-measured or laboratory plasma glucose level ≤36 mg/dL (≤2.0 mmol/L), or
the event was associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration."|on-treatment period (median duration of follow-up: 6.2 years)|The population analyzed was the safety population consisting of all randomized and treated patients (who received at least one dose of study drug) for the insulin glargine group and of all randomized patients for the standard care group.||participants|||Number
701671|NCT00069784|Secondary|Incidence of Development of Type 2 Diabetes Mellitus in Participants With IGT and/or IFG|The incidence was determined by calculating the proportion of randomized participants without diabetes at randomization who either developed diabetes during the study or who were classified as having possible diabetes based on results of two oral glucose tolerance tests (OGTT) performed after the last follow-up visit (within 21-28 days for OGTT#1 and within 10-14 weeks for OGTT#2).|from randomization until the last follow-up visit or last OGTT (median duration of follow-up: 6.2 years)|The analysis was based on the subgroup of the intent-to-treat (ITT) population without diabetes at randomization.||percentage of patients|||Number
701672|NCT00069784|Secondary|Composite Diabetic Microvascular Outcome (Kidney or Eye Disease)|"The composite outcome used to analyze microvascular disease progression contained components of clinical events:
the occurrence of laser surgery or vitrectomy for diabetic retinopathy (DR);
the development of blindness due to DR;
the occurrence of renal death or renal replacement therapy; as well as the following laboratory-based events:
doubling of serum creatinine; or
progression of albuminuria (from none to microalbuminuria [at least 30 mg/g creatinine], to macroalbuminuria [at least 300 mg/g creatinine])."|from randomization until study cut-off date (median duration of follow-up: 6.2 years)|"The analysis was based on the intent-to-treat (ITT) population i.e. all randomized participants.
For the endpoint's composition, the numbers only summarize the event when it was the first occurrence of the endpoint. A participant is counted only once within a category. The same participant may appear in different categories."||participants|||Number
701673|NCT00069784|Secondary|Total Mortality (All Causes)|Number of deaths due to any cause|from randomization until study cut-off date (median duration of follow-up: 6.2 years)|The analysis was based on the intent-to-treat (ITT) population, which was all randomized participants, regardless of compliance with the protocol.||participants|||Number
701674|NCT00069784|Primary|Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Revascularization Procedure or Hospitalization for Heart Failure (HF)|"Number of participants with a first occurrence of one of the above events (revascularization procedures included coronary artery bypass graft, percutaneous transluminal coronary angioplasty (PTCA) i.e. balloon, PTCA with stent, other percutaneous intervention, carotid angioplasty with/without stent, carotid endarterectomy, peripheral angioplasty with or without stent, peripheral vascular surgery, and limb amputation due to vascular disease).
The outcome's evaluation is based on the number of such positively-adjudicated first events occurring for patients assigned to the study groups. Assessments of the above events were reviewed by the Event Adjudication Committee who was kept blinded to the group assignment of participants.
Statistical analysis is performed on the time from randomization to the first occurrence of the events. Number of participants with a composite endpoint (i.e. with first occurrence of the events) is provided in the first row of the statistical table."|from randomization until study cut-off date (median duration of follow-up: 6.2 years)|"The analysis was based on the intent-to-treat (ITT) population i.e. all randomized participants.
For the endpoint's composition, the numbers only summarize the event when it was the first occurrence of the endpoint. A participant is counted only once within a category. The same participant may appear in different categories."||participants|||Number
701675|NCT00069784|Primary|Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI) or Nonfatal Stroke|"Number of participants with a first occurrence of one of the above events.
The outcome's evaluation is based on the number of such positively-adjudicated first events occurring for patients assigned to the study groups. Assessments of the above events were reviewed by the Event Adjudication Committee who was kept blinded to the group assignment of participants.
Statistical analysis is performed on the time from randomization to the first occurrence of the events. Number of participants with a composite endpoint (i.e. with first occurrence of CV death, nonfatal MI or nonfatal stroke) is provided in the first row of the statistical table."|from randomization until study cut-off date (median duration of follow-up: 6.2 years)|"The analysis was based on the intent-to-treat (ITT) population i.e. all randomized participants.
For the endpoint's composition, the numbers only summarize the event when it was the first occurrence of the endpoint. A participant is counted only once within a category. The same participant may appear in different categories."||participants|||Number
701676|NCT00069823|Secondary|Change in Number of Gastric Symptoms: No. of Symptoms|Mean change|Baseline to 24 Weeks|||symptoms||95% Confidence Interval|Mean
701677|NCT00069823|Secondary|Change in Gastric Symptoms: Gastroesophageal Reflux Disease Symptom Assessment Scale Score|Mean change. The Gastroesophageal Reflux Disease Symptom Assessment Scale score ranges from 0 to 3, with lower numbers indicating less distress.|Baseline to 24 Weeks|||score||95% Confidence Interval|Mean
701678|NCT00069823|Secondary|Change in Medical Outcomes Study Short-Form 36 Quality of Life Score: Mental Component|Mean change. Scores on the Medical Outcomes Study Short-Form 36 range from 1 to 100, with higher scores indicating better quality of life and 5 as the minimal clinically important difference.|Baseline to 24 Weeks|||score||95% Confidence Interval|Mean
701679|NCT00069823|Secondary|Change in Medical Outcomes Study Short-Form 36 Score Quality of Life Score: Physical Component|Mean change. Scores on the Medical Outcomes Study Short-Form 36 range from 1 to 100, with higher scores indicating better quality of life and 5 as the minimal clinically important difference.|Baseline to 24 Weeks|||score||95% Confidence Interval|Mean
701680|NCT00069823|Secondary|Change in the Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ)|Mean change. Scores on the Mini-Asthma Quality of Life Questionnaire (mini-AQLQ)range from 1 to 7, with higher scores indicating better quality of life and 0.5 as the minimal clinically important difference.|Baseline to 24 Weeks|||score||95% Confidence Interval|Mean
701681|NCT00069823|Secondary|Change in Asthma Symptom Utility Index (ASUI)|Mean change. Scores on the ASUI range from 0 to 1, with higher scores indicating less severe asthma.|Baseline to 24 Weeks|||score||95% Confidence Interval|Mean
701682|NCT00069823|Secondary|Change in Juniper Asthma Control Score(JACQ)|Mean change. Scores on the JACQ range from 0 to 6, with lower scores indicating better asthma control and 0.5 as the minimal clinically important difference.|Baseline to 24 Weeks|||score||95% Confidence Interval|Mean
701683|NCT00069823|Secondary|Pulmonary Function: Change in PC20|Mean Change in the dose of methacholine that results in a 20% drop in FEV1|Baseline to 24 Weeks|||mg/ml||95% Confidence Interval|Mean
701684|NCT00069823|Secondary|Pulmonary Function: Change in Peak Flow Rate|Mean change from baseline to 24 weeks in the peak flow rate - how forceful patient can blow out air|Baseline to 24 Weeks|||liters/min||95% Confidence Interval|Mean
701685|NCT00069823|Secondary|Pulmonary Function: Change in Prebronchodilator Forced Vital Capacity|Pulmonary function measured by mean change in Prebronchodilator forced vital capacity from baseline to 24 weeks|Baseline to 24 Weeks|||liters||95% Confidence Interval|Mean
701686|NCT00069823|Secondary|Pulmonary Function: Change in Prebronchodilator FEV1|Mean change in pre-bronchodilator FEV1 - forced expiratory volume in 1 second; a measure of pulmonary function. The treatment effect is the difference in the mean change in between the groups.|Baseline to 24 Weeks|The analyses are based on data from 191 participants in the placebo group and 201 in the esomeprazole group, with the following exception: 41 participants in the placebo group and 37 in the esomeprazole group for measurement of 20% post-diluent baseline (PC20).||liters||95% Confidence Interval|Mean
701687|NCT00069823|Secondary|Night Awakening|Rate of awakening at night because of asthma symptoms|Baseline to 24 Weeks|||events per person-year|||Number
701688|NCT00069823|Secondary|Use of Rescue Medications|Increase in the use of rescue meds by 4 or more uses on a particular day above the average uses during the run-in period.|Baseline to 24 Weeks|||events per person-year|||Number
701689|NCT00069823|Secondary|Asthma Episodes, According to Definition That Included Increased Use of Beta-agonists||Baseline to 24 Weeks|||events per person-year|||Number
701690|NCT00069823|Secondary|Exacerbation Components: New Use of Oral Corticosteroids||Baseline to 24 Weeks|||events per person year|||Number
701691|NCT00069823|Primary|Episodes of Poor Asthma Control (EPAC) From Diary Cards, According to Definition That Did Not Include Use of Beta-agonists as a Criterion|Episodes of poor asthma control was defined as any one of the following: 2 consecutive days with a drop in peak flow >=30% of baseline; urgent care for asthma; or new use of oral corticosteroids for asthma|Baseline to 24 Weeks|||events per person year|||Number
701692|NCT00069823|Secondary|Exacerbation Components: Urgent Care Visit||Measured at Month 6|||events per person-year|||Number
701693|NCT00069823|Secondary|Exacerbation Components: >=30% Drop in Peak Expiratory Flow on 2 Consecutive Days||Baseline to 24 Weeks|||events per person-year|||Number
701694|NCT00069953|Secondary|Frequency of Patients With Persistent or Recurrent Disease Eligible for Surgical Salvage Resection||Analysis occurs with the primary outcome measure.||||||
701695|NCT00069953|Secondary|Frequency of Major (Grade 4) Acute Treatment-related Toxicities||From start of chemotherapy to surgery or 2 months after chemoradiation (for patients not undergoing surgery).||||||
701696|NCT00069953|Primary|Overall Survival (1-year Rate Reported)|One-year survival estimate is reported. Survival time is defined as time from registration to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at date of last contact. This analysis was planned to occur when all patients had been potentially followed for 1 year. On the basis of a 1-year survival rate of 60% from the Radiation Therapy Oncology Group (RTOG) esophageal database, 38 analyzable patients with a 1-year survival rate of 77.5% or better was needed for this trial to be deemed promising enough for development of a Phase III protocol (type I error of 0.05 and type II error of 0.20).|From registration to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 1 year.|All eligible patients.||percentage of participants||95% Confidence Interval|Number
701697|NCT00070018|Primary|Progression-free Survival|Measured from date of registration to date of first observation of progression or symptomatic deterioration. Progression is defined as one or more of the following must occur. Unequivocal progression of disease in the opinion of the treating physician (an explanation must be provided). Appearance of a new lesion/site. Death due to disease without documented progression or symptomatic deterioration. Symptomatic deterioration is defined as global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.|at 6 weeks after treatment, then every 6 months for 2 years, then annually thereafter|||percentage of participants||95% Confidence Interval|Number
701698|NCT00070109|Secondary|Pharmacokinetics by a Miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method|The plasma concentration-versus-time data of trabectedin will be analyzed using noncompartmental methods. The typical population values of basic pharmacokinetic parameters will be estimated together with the interindividual variability.|At baseline, at 1, 8, 23, 24, 26, 30, 96, and 168 hours after trabectedin infusion in course 1||||||
701699|NCT00070109|Primary|Number of Patients With Dose-Limiting Toxicity (DLT)|Any Grade 3 or Grade 4 non-hematologic toxicity attributable to the Investigational drug with the specific exclusion of: Grade 3 nausea and vomiting; Grade 3 transaminase (AST/ALT) elevation that return to less than or equal to Grade 1 or baseline prior to the time for the next treatment cycle; Grade 3 fever or infection; Alopecia; Grade 4 neutropenia of > 7 days duration or Grade 4 thrombocytopenia of > 7 days duration, which requires transfusion therapy on greater than 2 occasions in 7 days, or which causes a delay of more than 14 days beyond the planned interval between treatment cycles.|1 Cycle|Two pts in Group 1 and 1 pt in Group 2 were excluded because they were removed from therapy prior to the DLT evaluation period and no DLT had been observed. No patients in Groups 3, 4, or 5 were evaluated for DLT.||participants|||Number
701700|NCT00070109|Primary|Response (Complete Response [CR] and Partial Response [PR])|Any patient who is enrolled and receives at least one dose of trabectedin will be considered evaluable for response if the individual receives at least one dose of trabectedin and: (1) is removed from protocol therapy because of progressive disease where progressive disease is documented either by imaging studies or clinical progression; or (2) has at least one radiographic evaluation of disease status after the start of protocol therapy and is not electively removed from protocol therapy with stable disease or is not lost to follow-up with stable disease. Patients who achieve a complete response (CR) - disappearance of all target lesions or partial response (PR) - >=30% decrease in the sum of the longest diameter of target lesions according to the RECIST criteria will be considered responders for the study design. All other patients who are evaluable for response will be considered non-responders for the study.|Twenty-six (26) cycles of chemotherapy or termination of protocol therapy, whichever occurs first.|No pts in Group 1 were evaluated for response. 1 pt in Group 3 is excluded because the pt was removed from protocol therapy after cycle 3 when a cardiac evaluation was missed. The pt was removed prior to disease assessment on protocol therapy. 1 pt enrolled in Group 4 was excluded because patient was removed from therapy prior to chemotherapy.||participants|||Number
701701|NCT00070135|Secondary|Non-relapse Mortality (NRM)|Percentage of patients who died due to causes other than relapse|Up to 5 years|||percentage of patients|||Number
701702|NCT00070135|Secondary|2 Year DFS for All Patients|Percentage of participants who were alive and relapse free at 2 years for all patients. The 2 year disease free survival, with 95% confidence interval, was estimated using the Kaplan Meier method.|Up to 2 years|||percentage of participants||95% Confidence Interval|Number
701703|NCT00070135|Primary|2 Year Disease Free Survival In Unrelated Donor Recipient Group|"Percentage of participants who were alive and relapse free at 2 years for patients who were matched with an unrelated donor for transplant. The 2 year disease free survival, with 95% confidence interval, was estimated using the Kaplan Meier method.
A relapse is defined as any of the following:
Reappearance of leukemia blasts cells in peripheral blood
>5% blasts in the marrow, not attributable to another cause (e.g., bone marrow regeneration)
If there are no circulating blasts, but the marrow contains 5-20% blasts, a repeat bone marrow ≥ 1 week later with >5% blasts is necessary to meet the criteria for relapse
The development of extramedullary leukemia or leukemic cells in the cerebral spinal fluid"|2 years|Participants who received a matched unrelated donor were included in this analysis.||percentage of participants||95% Confidence Interval|Number
701704|NCT00070291|Secondary|Overall Survival|Overall survival was defined as time from randomization to death from any cause.|Assessed every 3 months for 2 years, then every 6 months for 1 year.|all 4 enrolled patients||Months||95% Confidence Interval|Median
701705|NCT00070291|Primary|Response Rate (Complete and Partial Response)|Response was assessed based upon the criteria from the International Workshop to Standardize Criteria for Non-Hodgkin’s Lymphoma. Response included complete response and partial response. Complete response was defined as complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease related B-symptoms if present prior to therapy, as well as normalization of those biochemical abnormalities definitely attributed to NHL. All lymph nodes and nodal masses must have regressed to normal size. Partial response was defined as a decrease of > 50% in the SPD (sum of the products of the diameters) of the six largest (or less) dominant nodes or nodal masses, no increase in the size of the liver or the spleen, and no new sites of disease.|Assessed at weeks 6, 12, 24 and 36 from onset of treatment, and then at 1 year, 18 months, 2 years and 3 years from registration during follow-up.|all 4 enrolled patients||Proportion of participants||95% Confidence Interval|Number
701706|NCT00070317|Primary|False Negative Predictive Value (FNPV)|The proportion of patients with FNPV among patients who tests as negative sentinel node, where FNPV is defined as a person who tests as negative sentinel node but who actually has lymph node metastases|At the time of Surgery|Eligible and evaluable patients who tested as negative sentinel node and have lymph node sampling||Percentage of participants||90% Confidence Interval|Number
701707|NCT00070317|Primary|Sensitivity|Sensitivity is defined as the proportion of patients who test as positive sentinel node among the patients who have lymph node metastases.|At the time of surgery|Eligible and evaluable patients with lymph node metastasis and identified sentinel node||Percentage of participants||90% Confidence Interval|Number
701867|NCT00064792|Secondary|Cerebral Spinal Fluid Dehydrocholesterol to Total Sterol Ratio|Percent of 7-dehydrocholesterol + 8-dehydrocholesterol as a fraction of the total sterols (cholesterol + 7-dehydrocholesterol + 8-dehydrocholesterol measured in cerebral spinal fluid|12 months|||percent of total sterols||Standard Deviation|Mean
701713|NCT00070564|Secondary|Overall Survival Comparison Between 2 Treatments in HER-2 Positive Group.|Overall survival defined as time from registration to death as result of any cause. Results were entered as overall survival rate at year 5.|Biomarkers were measured by gene expression analysis before study entry. OS was measured every 6 months for 5 years|Patients with HER2-positive at baseline in each arm were included in this analysis. One patient in Arm II with no follow-up was excluded.||percentage of participants||95% Confidence Interval|Number
701714|NCT00070564|Secondary|Disease-free Survival Comparison Between 2 Treatments in HER2-positive Group|Disease-free survival (DFS) defined as time from registration (randomization assignment) to first instance of disease recurrence (local, regional, or distant), new breast primary tumor, or death as a result of any cause. The results are entered as disease free survival at year 5.|Biomarkers were measured by gene expression analysis before study entry. DFS was measured every 6 months for 5 years|Patients with HER2-positive at baseline in each arm were included in this analysis. One patient in Arm II with no follow-up was excluded.||percentage of participants||95% Confidence Interval|Number
701715|NCT00070564|Secondary|Overall Survival Comparison Between 2 Treatments in HR-negative, HER-2 Negative Group|Overall survival defined as time from registration to death as result of any cause. Results were entered as overall survival rate at year 5.|Biomarkers were measured by gene expression analysis before study entry. OS was measured every 6 months for 5 years|Patients with HR-negative, HER2-negative at baseline in each arm were included in this analysis.||percentage of participants||95% Confidence Interval|Number
701716|NCT00070564|Secondary|Disease-free Survival Comparison Between 2 Treatments in HR-negative, HER-2 Negative Group|Disease-free survival (DFS) defined as time from registration (randomization assignment) to first instance of disease recurrence (local, regional, or distant), new breast primary tumor, or death as a result of any cause. The results are entered as disease free survival at year 5.|Biomarkers were measured by gene expression analysis before study entry. DFS was measured every 6 months for 5 years|Patients with HR-negative, HER-2 negative at baseline in each arm were included in this analysis.||percentage of participants||95% Confidence Interval|Number
701717|NCT00070564|Secondary|Overall Survival Comparison Between 2 Treatments in HR-positive, HER-2 Negative Group|Overall survival defined as time from registration to death as result of any cause. Results were entered as overall survival rate at year 5.|Biomarkers were measured by gene expression analysis before study entry. OS was measured every 6 months for 5 years|Patients with HR-positive, HER-negative at baseline in each arm were included in this analysis.||percentage of participants||95% Confidence Interval|Number
701718|NCT00070564|Secondary|Disease-free Survival Comparison Between 2 Treatments in HR-positive, HER-2 Negative Group|Disease-free survival (DFS) defined as time from registration (randomization assignment) to first instance of disease recurrence (local, regional, or distant), new breast primary tumor, or death as a result of any cause. The results are entered as disease free survival at year 5.|Biomarkers were measured by gene expression analysis before study entry. DFS were measured every 6 months for 5 years|Patients with HR-positive, HER-2 negative at baseline in each arm were included in this analysis.||percentage of participants||95% Confidence Interval|Number
701719|NCT00070564|Secondary|Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs|Adverse Events (AEs) are reported by CTCAE Version 3.0. Only adverse events that are possibly, probably or definitely related to study drug are reported. The larger grade of Adverse event, the worse outcomes.|Toxicity assessment was evaluated every 4 weeks while on protocol therapy.|Limited to patients who started treatment, who did not have a major deviation in the treatment protocol, and whose toxicity profile has been completed.||Participants|||Number
701720|NCT00070564|Primary|Overall Survival|Overall survival defined as time from registration to death as result of any cause. Results were entered as overall survival rate at year 5.|Every 6 months for 5 years|Only eligible and analyzable patients were included in this analysis. Two patients in Arm II and one patient in Arm IV with no follow-up were excluded.||percentage of participants||95% Confidence Interval|Number
701721|NCT00070564|Primary|Disease-free Survival|Disease-free survival (DFS) defined as time from registration (randomization assignment) to first instance of disease recurrence (local, regional, or distant), new breast primary tumor, or death as a result of any cause. The results are entered as disease free survival at year 5.|every 6 months (annually for mammograms) for 5 years|Only eligible and analyzable patients were included in this analysis. Two patients in Arm II and one patient in Arm IV with no follow-up were excluded.||percentage of participants||95% Confidence Interval|Number
701722|NCT00070941|Primary|Change in Hamilton Depression Scale|very severe, >23/29; severe, 19–22/29; moderate, 14–18/29; mild, 8–13/29; and no depression, 0-7/29 (Hamilton M., J Neurol Neurosurg Psychiatry. 1960 Feb;23:56-62.)|12 weeks|||units on a scale||Standard Deviation|Mean
701723|NCT00071006|Secondary|Overall Survival (OS)|Time in days from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1). Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death). For participants who were alive, overall survival was censored at the last contact.|Baseline to death due to any cause or at least every 3 months after discontinuation of study treatment|Analysis for this particular endpoint was not conducted due to lack of efficacy.||Days||95% Confidence Interval|Median
701724|NCT00071006|Secondary|Population Pharmacokinetics of Axitinib (AG-013736)|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Day 1 (pre-dose) and every 4 weeks up to 35 weeks||||||
701725|NCT00071006|Secondary|Plasma Vascular Endothelial Growth Factor (VEGF) Concentration|VEGF promotes cancer progression by inducing angiogenesis via VEGF receptors, signals directly through receptors VEGFR-1 and VEGFR-2. Change in biomarkers related to VEGFR signal transduction pathways after axitinib treatment was assessed. Plasma VEGF concentration evaluations were performed using samples from peripheral blood plasma, bone marrow aspirate, bone marrow (Core) biopsy and bone marrow clot.|Day 1, Week 2 thereafter every 4 weeks up to 35 weeks and follow up (at least 30 days after last dose)|Data was not summarized for this particular endpoint due to lack of efficacy.||pg/mL||Standard Deviation|Mean
701885|NCT00072514|Secondary|Hematologic and Non-hematologic Adverse Events.|Count of participants with grade 3/4 hematologic and non-hematologic adverse events.|3-4 weeks after completion of study treatment|||Participants|||Count of Participants
701726|NCT00071006|Secondary|Vascular Endothelial Growth Factor Receptor 1 (VEGFR-1) and VEFGR Receptor 2 (VEGFR-2) Phosphorylation|Vascular endothelial growth factor (VEGF) promotes cancer progression by inducing angiogenesis via VEGF receptors, signals directly through receptors VEGFR-1 and VEGFR-2. Change in biomarkers related to VEGFR signal transduction pathways after axitinib treatment was assessed. Mononuclear (MNC) cell VEGF receptor expression and phosphorylation was assessed by in situ western blot analysis. VEGFR-1 and VEGFR-2 evaluations were performed using samples from peripheral blood plasma, bone marrow aspirate, bone marrow (Core) biopsy and bone marrow clot.|Day 1, Week 2 thereafter every 4 weeks up to 35 weeks and follow up (at least 30 days after last dose)|Data was not summarized for this particular endpoint due to lack of efficacy.||picograms (pg)/mL||Standard Deviation|Mean
701727|NCT00071006|Secondary|Bone Marrow Micro Vessel Density (MVD)|Bone marrow MVD in tumors is a measure of angiogenesis and a prognostic indicator that correlates with an increased risk of metastasis in various cancers and with overall and relapse free survival in participants with AML or MDS. Bone marrow biopsies and bone marrow clot samples were assessed for MVD (cluster of differentiation 31 [CD31] staining).|Day 1, Week 2 thereafter every 4 weeks up to 35 weeks|Data was not summarized for this particular endpoint due to lack of efficacy.||vessels/square millimeter (mm^2)||Standard Deviation|Mean
701728|NCT00071006|Secondary|Duration of Response (DR)|Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1). DR was calculated for the subgroup of participants with a confirmed objective tumor response.|First documentation of objective response until objective disease progression or discontinuation from the study due to any cause assessed every 4 weeks up to 35 weeks|Analysis for this particular endpoint was not conducted due to lack of efficacy.||Days||95% Confidence Interval|Median
701729|NCT00071006|Secondary|Percentage of Participants With Hematologic Improvement (HI)|HI was described by the number of individual and positively affected cell lines (Erythroid response, Platelet response, Neutrophil response). Improvements must last at least 2 months.|Baseline, Week 2 thereafter every 4 weeks up to 35 weeks and follow up (at least 30 days after last dose)|Analysis for this particular endpoint was not conducted due to lack of efficacy.||Percentage of participants||95% Confidence Interval|Median
701730|NCT00071006|Primary|Percentage of Participants With Objective Response (OR)|Participants with OR based on a assessment of confirmed complete remission (CR) or partial remission (PR) according to Cheson criteria for Acute myeloid leukemia (AML) and Myelodysplastic syndrome (MDS). CR: those with > 20% cellularity of bone marrow biopsy, no presence of extramedullary leukemia for AML, <5 % myeloblast cells for bone marrow with peripheral blood value lasting at least 1 month and 2 months for AML and MDS respectively. PR : those with all criteria for CR except 5-25 % blasts in bone marrow and at least 50% decrease in blast over pretreatment for AML and MDS respectively.|Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 4 weeks up to 35 weeks|Study Population included all participants who received at least 1 dose of study medication and had a baseline assessment of disease.||Percentage of participants||95% Confidence Interval|Number
701731|NCT00071032|Secondary|Composite Outcomes (a) Death, Myocardial Infarction, and Pneumonia and b) Death, Myocardial Infarction, Pneumonia, Thromboembolism and Stroke)||In-hospital||||||
701732|NCT00071032|Secondary|Myocardial Infarction||In-hospital||||||
701733|NCT00071032|Secondary|Length of Stay in Hospital||In-hospital||||||
701734|NCT00071032|Secondary|Function (e.g., Lower Extremity Activities of Daily Living, Instrumental Activities of Daily Living, Fatigue/Energy)||30 and 60 days||||||
701735|NCT00071032|Secondary|Disposition Status (i.e., Nursing Home Placement)||60 days||||||
701736|NCT00071032|Secondary|Survival||30-daym, 60- day and long term up to 5 years||||||
701737|NCT00071032|Secondary|Postoperative Complications (e.g., Pneumonia, Wound Infection, Thromboembolism, Stroke)||In hospital||||||
701738|NCT00071032|Secondary|Myocardial Infarction, Unstable Angina, or Death for Any Reason||In-hospital|||participants|||Number
701739|NCT00071032|Primary|Inability to Walk 10 Feet or Across a Room Without Human Assistance or Death|ascertained via telephone follow-up|60 days after randomization|||participants|||Number
701740|NCT00071058|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|60 months, 19 days|||Participants|||Number
701741|NCT00071058|Primary|Percentage of Participants With a Partial or Complete Response|Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete response is defined as the disappearance of all signs and symptoms of tumor for a period of at least 4 weeks. Partial response is defined as at least a 30% decrease in the sum of the longest diameter of all measured lesions lasting for a period of 4 weeks.|Every 6 weeks for up to a year|||Percentage of participants|||Number
701742|NCT00071110|Secondary|Change in Functioning and Health-related Quality of Life as Rated by the Medical Outcomes Survey-Version 1 (MOS-36) Bodily Pain Index (MOSBPI)|Mean change in scores on the Medical Outcomes Survey-Version 1 (MOS-36) Bodily Pain Index (MOSBPI) from baseline to post-intervention across treatment group. Minimum Score = 0 (more); Maximum Score = 100 (less). Positive Mean Change scores indicate improvement (an increase in scale score/less pain).|Mean Change from Baseline to Post-Intervention Endpoint|ITT, excluding the first four sham acupuncture subjects, whom the primary acupuncturist erred in treating. Although he correctly used the sham electricity procedure, for these subjects he placed needles in the verum electroacupuncture points of GV-20 and Yin tang.||Units on a scale||Standard Deviation|Mean
701743|NCT00071110|Secondary|Change in Functioning and Health-related Quality of Life as Rated by the Medical Outcomes Survey-Version 1 (MOS-36) Mental Component Score (MOSMCS)|Mean change in scores on the Medical Outcomes Survey-Version 1 (MOS-36) Mental Component Score (MOSMCS) from baseline to post-intervention across treatment group. Minimum Score = 0 (worse); Maximum Score = 100 (better) , Normed to be at 50 on a control population. Positive Mean Change scores indicate improvement (an increase in scale score).|Mean Change from Baseline to Post-Intervention Endpoint|ITT, excluding the first four sham acupuncture subjects, whom the primary acupuncturist erred in treating. Although he correctly used the sham electricity procedure, for these subjects he placed needles in the verum electroacupuncture points of GV-20 and Yin tang.||Units on a scale||Standard Deviation|Mean
701744|NCT00071110|Secondary|Change in Functioning and Health-related Quality of Life as Rated by the Medical Outcomes Survey-Version 1 (MOS-36) Physical Component Score (MOSPCS)|Mean change in scores on the Medical Outcomes Survey-Version 1 (MOS-36) PHYSICAL Component Score (MOSPCS) from baseline to post-intervention across treatment group. Minimum Score = 0 (worse); Maximum Score = 100 (better), Normed to be at 50 on a control population. Positive Mean Change scores indicate improvement (an increase in scale score/better).|Mean Change from Baseline to Post-Intervention Endpoint|ITT, excluding the first four sham acupuncture subjects, whom the primary acupuncturist erred in treating. Although he correctly used the sham electricity procedure, for these subjects he placed needles in the verum electroacupuncture points of GV-20 and Yin tang.||Units on a scale||Standard Deviation|Mean
701745|NCT00071110|Primary|Antidepressant Response, Defined as a Hamilton Depression Rating Scale Score Relative Decrease of 50 % or More and a Final Score < 10|Number of participants whose Hamilton Depression Rating Scale score decreased at least 50% and had a final score less than 10. Minimum score = 0 (best). Maximum score = 52 (worst). The 17 item scale assesses depression symptoms, including Depressed Mood, Feelings of Guilt, Suicidal Ideation, Insomnia, Anxiety, Weight Change, and Insight.|Change from Baseline to Post-Intervention Endpoint|ITT, excluding the first four sham acupuncture subjects, whom the primary acupuncturist erred in treating. Although he correctly used the sham electricity procedure, for these subjects he placed needles in the verum electroacupuncture points of GV-20 and Yin tang.||participants|||Number
701746|NCT00071396|Primary|Overall Response|Overall response categorized as 'Complete Remission,' 'Partial Remission,' or 'No Response.' Blood tests weekly while on active therapy, within 4-6 weeks following last dose of therapy, and every 3 to 6 (+/- month) thereafter as long as on study. Repeat bone marrow biopsy/aspirate with flow cytometry as applicable at the end of first course of therapy, (1 week) within 4-6 weeks following the last dose of therapy and every 6 to 12 months (+/-) thereafter as long as on study.|After each 4 week course of treatment|Analysis treated population 41 evaluable patients (44 treated, 3 not evaluable for response).||Participants|||Number
701747|NCT00071487|Other Pre-specified|Adverse Events (AE) Overview|Includes AEs reported in patients from the first dose of study agent throughout the study up to the Week 76/exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (LBSL99/NCT00583362).|Up to 84 weeks|||percentage of participants|||Number
701748|NCT00071487|Secondary|Percentage of Patients With a Reduction in Prednisone Dose|Percentage of patients whose average prednisone dose has been reduced by ≥ 50% and/or has been reduced to ≤ 7.5 mg/day during Weeks 40 through 52 in patients receiving greater than 7.5 mg/day at baseline.|Baseline, weeks 40 to 52|Analysis was performed on a subgroup of the MITT population, which included only patients with baseline prednisone dose > 7.5 mg/day.||percentatge of particpants|||Number
701749|NCT00071487|Secondary|Time to First Type A/B SLE Flare (as Defined Using BILAG) Over 52 Weeks|SLE flare indicates an increase in SLE disease activity. An SLE flare was a type A or B SLE flare (as defined using BILAG) compared with the previous visit.|0 to 52 weeks|Analysis was performed on a MITT population, defined as all patients who were randomized and received at least 1 dose of study agent.||days||Inter-Quartile Range|Median
701750|NCT00071487|Secondary|Area Under the Curve (AUC) of BILAG Score at Week 52|The BILAG index is a clinical measure of lupus disease activity. BILAG uses a single score for each of the 8 organ domains; range is from severe to no disease (A to E). The global BILAG score is the sum of the numerical scores in the 8 domains assigning A=9, B=3, C=1, D=0, E=0.The normalized AUC was created as the ratio of the area under the global BILAG score curve divided by baseline score.|Baseline and every 4 to 8 weeks through Week 52|Analysis was performed on a MITT population, defined as all patients who were randomized and received at least 1 dose of study agent.||ratio score*days||Standard Error|Mean
701751|NCT00071487|Secondary|Percentage Change From Baseline in British Isles Lupus Activity Group (BILAG) Score at Week 52|The BILAG index is a clinical measure of lupus disease activity. BILAG uses a single score for each of the 8 organ domains; range is from severe to no disease (A to E). The global BILAG score is the sum of the numerical scores in the 8 domains assigning A=9, B=3, C=1, D=0, E=0.|Baseline, 52 weeks|Analysis was performed on a MITT population, defined as all patients who were randomized and received at least 1 dose of study agent.||percent change||Standard Error|Mean
701752|NCT00071487|Secondary|Area Under the Curve (AUC) of SELENA SLEDAI Score at Week 52|SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare. The normalized AUC was created as the ratio of the area under the SELENA SLEDAI score curve divided by baseline score.|Baseline and every 4 to 8 weeks through Week 52|Analysis was performed on a MITT population, defined as all patients who were randomized and received at least 1 dose of study agent.||ratio score*days||Standard Error|Mean
701753|NCT00071487|Secondary|Percentage Change From Baseline in SELENA SLEDAI Score at Week 52|SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare|Baseline, 52 weeks|Analysis was performed on a MITT population, defined as all patients who were randomized and received at least 1 dose of study agent.||percent change||Standard Error|Mean
701754|NCT00071487|Primary|Time to First Mild/Moderate or Severe SLE Flare (SLE Flare Index)|"The SLE Flare Index categorized SLE flare as mild or moderate or severe based on 5 variables: 1) change in SELENA SLEDAI score from the most recent assessment to current, 2) change in signs or symptoms of disease activity, 3) change in prednisone dosage, 4) use of new medications for disease activity or hospitalization, and 5) change in Physician's Global Assessment score, a visual analog scale scored from 0 to 3 (1=mild, 2=moderate, 3=severe)."|0 to 52 weeks|Analysis was performed on a MITT population, defined as all patients who were randomized and received at least 1 dose of study agent.||days||Inter-Quartile Range|Median
701755|NCT00071487|Primary|Percentage Change From Baseline in Safety of Estrogens in Lupus Erythematosus National Assessment SLE Disease Activity Index (SELENA SLEDAI) Score at Week 24.|SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare.|Baseline, 24 weeks|Analysis was performed on a modified intention-to-treat (MITT) population, defined as all patients who were randomized and received at least 1 dose of study agent.||percent change||Standard Error|Mean
703673|NCT00095498|Secondary|Change From Baseline in Eosinophils at Month 6|Laboratory hematology eosinophils|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.||* 10^9/L||Standard Deviation|Mean
701756|NCT00071513|Secondary|School Attachment|"School attachment measure consisted of 4 items. Item responses range from 0 (unsatisfied, rarely attended, not involved, etc.) to 6 (highly satisfied, regularly attended, very involved, etc). Scores could range from 0 to 36 with higher scores indicating more positive school attachment. Item were:
My overall satisfaction with classes was… Overall, how safe did school feel last semester… Overall, how friendly did school feel… How involved were you in school activities…"|18 months|T-test differences for HSTS versus Brief Intervention on the School Attachment scale.||units of a scale||Standard Deviation|Mean
701757|NCT00071513|Primary|Change in Short Moods and Feelings Questionnaire (SMFQ)|"The Short Moods and Feelings Questionnaire is a 13 item measure of level of self reported depressive symptoms. Each item in scored on a 3-point Likert scale as follows: True (0), Sometimes (1), and Not True (2) rated within the timeframe of the previous two weeks. A total score is obtained; scores can range from 0 to 26. Total scores of 12 or higher may signify that a child/adolescent is suffering from depression. Higher scores on this scale suggest a worse outcome or greater endorsement of depressive symptoms. Change is measured based on two time points baseline to the 18 months follow-up assessment."|Baseline to 18 months|The main study hypothesis was that at-risk middle school students randomly assigned to participate in the CAST-T/HSTS versus the Brief Intervention would demonstrate a greater reduction in self-reported depressive symptoms after the 8th grade intervention as well as lower rate of increase in depressive symptoms at the 18 mos. follow-up.||units on a scale||Standard Deviation|Mean
701758|NCT00071721|Secondary|Participant’s Clinical Condition or Endpoint Assessed With the ADCS-Clinical Global Impression of Change (ADCS-CGIC)|ADCS-Clinical Global Impression of Change (ADCS-CGIC) provides a means to reliably assess global change from baseline. It provides a semi-structured format to allow clinicians to gather necessary clinical information from both the participant and informant, in order to make an overall impression of clinical change. The range of this instrument is 1 to 7 with lower numbers indicating improvement and higher numbers indicating a worsened state.|24 months|||Units on a scale||Standard Deviation|Mean
701759|NCT00071721|Secondary|Agitation Measured by the Cohen-Mansfield Agitation Inventory (CMAI), Community Version|The Cohen-Mansfield Agitation Inventory (CMAI) is a 29-item caregiver rating questionnaire for the assessment of agitation in older persons. It includes descriptions of 29 agitated behaviors, each rated on a 7-point scale of frequency. The range of this instrument is 29 to 203 with higher numbers indicating greater impairment.|24 months|||Units on a scale||Standard Deviation|Mean
701760|NCT00071721|Secondary|Global Severity of Dementia Using the CDR Sum of Boxes|Clinical Dementia Rating, Sum of Boxes (CDR-SOB) is a global rating of dementia severity based on the clinician's interpretation of the history and examination. The range of this instrument is 0 to 18 with higher numbers indicating greater impairment.|24 months|||Units on a scale||Standard Deviation|Mean
701761|NCT00071721|Secondary|Functional Performance Assessed by the Alzheimer’s Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Inventory|Alzheimer's Disease Cooperative Study Activities of Daily Living Score (ADCS-ADL) is a structured questionnaire about activities of daily living, administered to the subject's caregiver/study partner. The range of this instrument is 0 to 78 with lower numbers indicating greater impairment.|24 months|||Units on a scale||Standard Deviation|Mean
701762|NCT00071721|Secondary|Cognitive Performance Assessed by the Alzheimer's Disease Assessment Scale-cognitive Subtest (ADAS-cog)|Alzheimer's Disease Assessment Scale, cognitive sub-scale in points per year (ADAS-cog) is a psychometric measure sensitive to change in mild to moderate AD. The range of this instrument is 0 to 70 with higher numbers indicating greater impairment.|24 months|||Units on a scale||Standard Deviation|Mean
701763|NCT00071721|Primary|Presence of Agitation and/or Psychosis Measured by the Neuropsychiatric Inventory (NPI) Combined With an Assessment of the Clinical Significance of Behavioral Change Rated by the Study Clinician|NPI quantifies behavioral changes in dementia, including depression, anxiety, psychosis, agitation, and others. This is a questionnaire administered to the subject's study partner. The range of this instrument is 0 to 120 with higher numbers indicating greater impairment. To determine whether or not psychosis or agitation is present, there is no cutoff score but is based on the clinician’s judgment. In the NPI, the subject responds to ‘Yes’ or ‘No’ questions. Then it is determined how often psychosis or agitation occurs and if it is mild, moderate or severe.|24 months|||Participants|||Number
701764|NCT00071760|Secondary|Plasma FPV CL/F Expressed in mL/Min|The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.|Week 48|PK Population|||||
701765|NCT00071760|Secondary|Plasma FPV CL/F Expressed in mL/Min/kg|The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.|Week 48|PK Population|||||
701766|NCT00071760|Secondary|Plasma FPV Cmax and Cτ|The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.|Week 48|PK Population|||||
701767|NCT00071760|Secondary|Plasma FPV AUC (0-τ)|The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.|Week 48|PK Population|||||
701768|NCT00071760|Secondary|Correlation Between Steady-state Plasma APV PK Parameters to Changes in Plasma HIV-1 RNA Concentrations, CD4+ Percentages, and/or the Occurrence of Adverse Events|No formal analysis has been performed or is planned to correlate plasma APV PK with efficacy and safety outcomes.|Week 48|PK Population|||||
701769|NCT00071760|Secondary|Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child’s Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10|Parent/guardian perceptions of FPV/RTV BID was assessed using a Parent/Guardian Perception of Study Medication questionnaire. Questions 1 to 4 ask directly about the parent/guardian's assessment of the color, texture/consistency, odor, and general satisfaction. Questions 5 to 10 ask about the parent/guardian’s perception of the child’s assessment of the oral suspension (Items: 5=reaction to new medicine [med.]; 6=taste; 7=acceptance; 8=swallowing; 9=willingness compared to other med.; 10=overall liking. Data for items 6/10 are reported in response categories: 1-3=dislike; 4=neutral; 5-7=like.|Weeks (W) 2, 24, and 48/premature study discontinuation|Safety Population||participants|||Number
701815|NCT00071812|Other Pre-specified|Adverse Events (AE) Overview|Includes AEs reported in patients from the first dose of study agent throughout the study up to the Week 48/exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (LBRA99/NCT00583557).|Up to 56 weeks|||percentage of participants|||Number
701770|NCT00071760|Secondary|Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4|P/G perceptions of FPV/RTV BID were assessed using a P/G Perception of Study Medication questionnaire administered during Weeks 2, 24, and 48/premature study discontinuation. Questions 1 to 4 ask directly about the P/G's assessment of 1=color, 2=texture/consistency, 3=odor, and 4=general satisfaction. Questions 5 to 10 ask about the P/G’s perception of the child’s assessment of the oral suspension. Data are reported as the number of participants with the indicated response by question, response category (1-3=dislike, 4=neutral, 5-7=like), and timing of visit.|Weeks 2, 24, and 48/premature study discontinuation|Safety Population||participants|||Number
701771|NCT00071760|Secondary|Number of Participants Reporting Perfect Adherence Over the 3 Days and Last Weekend Prior to the Study Visits at Weeks 2, 12, 24, and 48 as Assessed by the Study Coordinator Using the Adherence Questionnaire|A separate questionnaire were administered for FPV and RTV. Items 1-4 of the Adherence Questionnaire measured a participant's adherence with FPV or RTV during the last 3 days and the weekend prior to the indicated study visits. Question 5 queried about the number of doses of FPV or RTV missed since the participant’s last study visit. Perfect adherence was defined as not missing any doses of FPV or RTV since the last study visit.|Weeks 2, 12, 24, and 48|Safety Population. Only those participants contributing data at the indicated time points were analyzed.||participants|||Number
701772|NCT00071760|Secondary|Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS)|A blood sample was drawn for par. failing to respond to therapy, and changes in DS for HIV isolated from the par. for each drug used in the study were assessed. The changes in DS detected by phenotypic assay in virus from the sample collected at the time of failure was compared with DS in the virus from the blood sample at baseline. Par. are grouped by study arm and prior therapy experience. DS is the state of HIV being susceptible to the antiretroviral agent (the virus can be inhibited by the drug). Reduced DS (i.e., HIV is resistant to the antiretroviral agent) can lead to treatment failure.|Baseline through Week 48|VF: par. with failure to achieve plasma HIV-RNA <400 copies/mL by Week 24; or confirmed HIV-RNA rebound to >=400 copies/mL any time after achieving plasma HIV-RNA <400 copies/mL and had evaluable viral isolate genotypic and/or phenotypic data. Only par. contributing viral phenotype at both baseline and the indicated time of VF points were evaluable||participants|||Number
701773|NCT00071760|Secondary|Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease|A blood sample was drawn for par. failing to respond to therapy, and the mutations present in the virus were identified. For each par., the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New International AIDS Society-USA defined resistance mutations that developed at the time of failure were tabulated by drug class. VF, virologic failure; NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor. Par. are grouped by study arm and prior therapy experience.|Baseline through Week 48|VF: par. with failure to achieve plasma HIV-RNA <400 copies/mL by Week 24; or confirmed HIV-RNA rebound to >=400 copies/mL any time after achieving plasma HIV-RNA <400 copies/mL and had evaluable viral isolate genotypic and/or phenotypic data. Only par. contributing viral genotype at both baseline and the indicated time of VF points were evaluable.||participants|||Number
701774|NCT00071760|Secondary|Plasma RTV CL/F Expressed in mL/Min|Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated as dose in mg/kg units divided by AUC(0-τ).|Week 48|PK Population. Only those participants contributing data were analyzed.||mL/min||95% Confidence Interval|Geometric Mean
701775|NCT00071760|Secondary|Plasma RTV CL/F Expressed in mL/Min/kg|Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated as dose in mg/kg units divided by AUC(0-τ). Normalizing CL/F for bodyweight allows for comparison of CL/F across populations.|Week 48|PK Population. Only those participants contributing data were analyzed.||mL/min/kg||95% Confidence Interval|Geometric Mean
701776|NCT00071760|Secondary|Plasma RTV Cτ|The plasma concentration at the end of the dosing interval at steady state (Cτ) was measured.|Week 48|PK Population. Only those participants contributing data were analyzed.||µg/mL||95% Confidence Interval|Geometric Mean
701777|NCT00071760|Secondary|Plasma RTV Cmax|The maximum concentration at steady state (Cmax) was measured.|Week 48|PK Population. Only those participants contributing data were analyzed.||µg/mL||95% Confidence Interval|Geometric Mean
701778|NCT00071760|Secondary|Plasma Ritonavir (RTV) AUC (0-τ)|Plasma samples were assayed for RTV concentrations using a validated assay. The GSK Department of Clinical Pharmacology Modeling and Simulation conducted PK analysis of the plasma RTV concentration-time data using a model-independent approach. As a measure of total drug exposure, the area under the plasma-concentration-versus-time curve over the dosing interval at steady-state (AUC[0-τ]), where τ is the length of the dosing interval, was calculated by the linear up/log down trapezoidal method.|Week 48|PK Population. Only those participants contributing data were analyzed.||hr*µg/mL||95% Confidence Interval|Geometric Mean
701779|NCT00071760|Secondary|Number of Participants With the Indicated Virological Outcome at Week 48|Blood samples of participants were collected to measure plasma HIV-1 RNA concentrations. PI-exp = PI-experienced. Virologic success was defined as plasma HIV-1 RNA <400 copies/mL. Virologic failure: (1) HIV-1 RNA >=400 copies/mL, (2) change of background antiretroviral treatment (ART), (3) discontinued study due to lack of efficacy, (4) discontinued study with last HIV-1 >=400 copies/mL. No virologic data at Week 48 window: (a) discontinued study due to an adverse event or death, (b) discontinued study due to other reasons (withdrew consent, loss to follow-up, moved, etc.).|Week 48|ITT-E Population. Only those participants contributing data were analyzed.||participants|||Number
701780|NCT00071760|Secondary|Median Percent Change From Baseline in CD4+ Cell Count at Weeks 4, 12, 24, 36, and 48|Blood samples of participants were collected for the measurement of the percentage of total lymphocytes that are CD4+ cells. Observed analysis was used for the summary of proportion endpoints using viral load data. Change from Baseline in percentage was calculated as the value at indicated time points minus the value at Baseline.|Baseline and Weeks 4, 12, 24, 36, and 48|ITT-E Population. Only those participants contributing data at the indicated time points were analyzed. Not all participants had values at both baseline and the indicated time points; thus, change from baseline could not be calculated for all participants.||Percentage of cells||Inter-Quartile Range|Median
726379|NCT00360828|Secondary|Overall Survival at 6 Months|Patients surviving 6 months after treatment end|6 months post treatment end|All participants who received at least one dose of drug||participants|||Number
701781|NCT00071760|Secondary|Median Percent Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 4, 12, 24, 36, and 48|Blood samples of participants were collected for the measurement of the percentage of total lymphocytes that are CD4+ cells. Observed analysis was used for the summary of proportion endpoints using viral load data. CD4+ cells are white blood cells that are important in fighting infection. HIV infects CD4+ cells, replicates in them, and destroys them. A CD4+ cell count provides a measure of the status of the immune system and to what extent it is affected by HIV.|Baseline and Weeks 4, 12, 24, 36, and 48|ITT-E Population. Only those participants contributing data at the indicated time points were analyzed.||Percentage of cells||Inter-Quartile Range|Median
701782|NCT00071760|Secondary|Number of Participants With at Least a 1.0 log10 HIV-1 RNA Decrease From Baseline at Weeks 4, 12, 24, 36, and 48 (MSD=F Analysis)|Blood samples of participants were collected to assess the decrease in the number of HIV-1 RNA copies. In the MSD=F analysis, participants who had missing data at or had discontinued the study prior to a certain time point or had changed their background antiretroviral regimen are classified as non-responders.|Baseline and Weeks 4, 12, 24, 36, and 48|ITT-E Population. Only those participants contributing data at the indicated time points were analyzed.||participants|||Number
701783|NCT00071760|Secondary|Median Change From Baseline in Plasma HIV-1 RNA (log10 Copies/mL) at Weeks 4, 12, 24, 36, and 48 (Observed Analysis)|Blood samples of participants were collected to assess the decrease in the number of HIV-1 RNA copies. Change from Baseline in plasma HIV-1 RNA was calculated as the value at the indicated time point minus the value at Baseline.|Baseline and Weeks 4, 12, 24, 36, and 48|ITT-E Population. In the observed analysis, data are presented for the number of participants still enrolled in the study at a certain time point.||log10 copies/mL||Inter-Quartile Range|Median
701784|NCT00071760|Secondary|Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 4, 12, 24, 36, and 48 (Observed Analysis)|Blood samples of participants were collected to assess the decrease in the number of HIV-1 RNA copies.|Baseline and Weeks 4, 12, 24, 36, and 48|ITT-E Population. In the observed analysis, data are presented for the number of participants still enrolled in the study at a certain time point.||log10 copies/mL||Inter-Quartile Range|Median
701785|NCT00071760|Secondary|Number of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 Copies Per Milliliter at Baseline and Weeks 4, 12, 24, 36, and 48 (MSD=F)|Blood samples of participants were collected to measure plasma HIV-1 RNA concentrations. Viral load, measured in RNA copies per milliliter of plasma, is an efficacy measure for antiretroviral drugs. In the Missing, Switch, or Discontinuation=Failure (MSD=F) analysis, participants who had missing data at or had discontinued the study prior to a certain time point or had changed their background antiretroviral regimen are classified as non-responders.|Baseline and Weeks 4, 12, 24, 36, and 48|Intent-to-Treat Exposed (ITT-E) Population: participants who received chronic therapy with FPV or FPV/RTV at any dose. Only those participants contributing data at the indicated time points were analyzed.||participants|||Number
701786|NCT00071760|Primary|Number of Participants Who Permanently Discontinued the Treatment Due to an AE|An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Baseline (Day 1) until Week 48|Safety Population. In addition to the 54 participants starting FPV/RTV BID treatment, the FPV/RTV BID treatment group includes 5 participants who only received investigational product at the single dose visits in APV20002.||participants|||Number
701787|NCT00071760|Primary|Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Adverse Events (AE)|An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE is considered TE if it has an onset date on or after the date of the first dose of study drug, and on or before the date of the final dose of study drug. As per the Division of AIDS Table for Grading the Severity of Adult and Pediatric AEs, Grade 3=severe; Grade 4=potentially life-threatening.|Baseline (Day 1) until Week 48|Safety Population. In addition to the 54 participants starting FPV/RTV BID treatment, the FPV/RTV BID treatment group includes 5 participants who only received investigational product at the single dose visits in APV20002.||participants|||Number
701788|NCT00071760|Primary|Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Laboratory Abnormalities|TE toxicities were presented for each laboratory parameter. A toxicity was considered TE if it was greater than the Baseline grade, and if it was observed on/after the date of the first dose of study drug (SD), and on/before the date of the last dose of SD. Neutropenia is a decrease (d) in the number of Ns, d/increase (I) in glucose is hypo (Hp)/hyper (Hy)glycemia, in potassium is Hp/Hykalemia, and in sodium is Hp/Hynatremia. Per the Division of AIDS Table for Grading the Severity of Adult and Pediatric AEs, Grade 3=severe; Grade 4=potentially life-threatening.|Baseline (Day 1) until Week 48|Safety Population. Only those participants contributing data were analyzed.||participants|||Number
701789|NCT00071760|Primary|Median Change From Baseline in Serum Lipase at Weeks 4, 12, 24, and 48|Blood samples of all participants were collected for the evaluation of serum lipase. Clinical chemistry analyses were carried out using the observed analysis strategy. Change from Baseline in serum lipase was calculated as the value at the indicated time point minus the value at Baseline.|Baseline (Day 1) and Weeks 4, 12, 24, and 48|Safety Population. Only those participants contributing data were analyzed.||Units per liter (U/L)||Inter-Quartile Range|Median
701790|NCT00071760|Primary|Median Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Triglyceride (TG), Potassium, and Sodium at Weeks 4, 12, 24, 36, and 48|Blood samples of all participants were generally collected under non-fasting conditions (given the age of participants) for the evaluation of cholesterol, serum glucose, HDL cholesterol, LDL cholesterol, triglyceride, potassium, and sodium. Clinical chemistry analyses were carried out using the observed analysis strategy. Change from Baseline in cholesterol, serum glucose, HDL cholesterol, LDL cholesterol, triglyceride, potassium, and sodium was calculated as the value at the indicated time point minus the value at Baseline.|Baseline (Day 1) and Weeks 4, 12, 24, 36, and 48|Safety Population. Only those participants contributing data were analyzed.||Millimoles per liter (mmol/L)||Inter-Quartile Range|Median
701830|NCT00071981|Secondary|Helper T Cell Response to Tetanus|Helper T cell response was evaluated by tritiated thymidine proliferation assay with fresh/cryopreserved PBL in the presence of each of the helper peptides.|Immune response was assessed at pre-registration, in weeks 1,3,5,7,8|128 eligible and treated patients who had data about HTL response to tetanus peptide were included in the analysis||percentage of participants||95% Confidence Interval|Number
701791|NCT00071760|Primary|Median Change From Baseline in Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) at Weeks 4, 12, 24, 36, and 48|Blood samples of the participants were collected for the evaluation of ALT and AST. Clinical chemistry analyses were carried out using the observed analysis strategy. Change from Baseline in ALT and AST was calculated as the value at the indicated time point minus the value at Baseline.|Baseline (Day 1) and Weeks 4, 12, 24, 36, and 48|Safety Population: all participants with documented evidence of having received at least one dose of investigational treatment. Only those participants contributing data were analyzed.||International units per liter (IU/L)||Inter-Quartile Range|Median
701792|NCT00071760|Primary|Plasma Unbound APV Percent Protein Binding (%Cτ)|Participants who are <2 years old may have reduced protein binding; therefore, plasma unbound APV concentrations were measured to determine dosing recommendations at acceptable dosing volumes. APV %Cτ unbound is the percentage of the total APV Cτ that is unbound.|Week 48|PK Population. Only those participants contributing data were analyzed.||Percentage of total APV Cτ unbound||Standard Deviation|Mean
701793|NCT00071760|Primary|Plasma Unbound APV Cτ|"Participants who are <2 years old may have reduced protein binding; therefore, plasma unbound APV concentrations were measured to determine dosing recommendations at acceptable dosing volumes. Unbound or free APV is the fraction of drug that is not bound to protein. Cτ is the plasma concentration at the end of the dosing interval at steady state."|Week 48|PK Population. Only those participants contributing data were analyzed.||µg/mL||Standard Deviation|Mean
701794|NCT00071760|Primary|Plasma APV CL/F Following Dosing Expressed in mL/Min|Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated as dose/AUC(0-τ). For FPV, doses were expressed in APV molar equivalents (50 mg of FPV = 43.2 mg of APV).|Week 48|PK Population. Only those participants contributing data were analyzed.||mL/min||95% Confidence Interval|Geometric Mean
701795|NCT00071760|Primary|Plasma APV CL/F Following Dosing Expressed in mL/Min/kg|Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated using the formulation: APV Dose in mg/kg units divided by AUC(0-τ). For FPV, doses were expressed in APV molar equivalents (50 mg of FPV = 43.2 mg of APV). Normalizing CL/F for bodyweight allows for comparison of CL/F across populations.|Week 48|PK Population. Only those participants contributing data were analyzed.||Milliliters/minute/kilogram (mL/min/kg)||95% Confidence Interval|Geometric Mean
701796|NCT00071760|Primary|Plasma APV Cτ|The plasma concentration at the end of the dosing interval at steady state (Cτ) was measured.|Week 48|PK Population. Only those participants contributing data were analyzed.||Micrograms per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
701797|NCT00071760|Primary|Plasma APV Cmax|The maximum concentration at steady state (Cmax) was measured.|Week 48|PK Population. Only those participants contributing data were analyzed.||Micrograms per milliliter (µg/mL)||95% Confidence Interval|Least Squares Mean
701798|NCT00071760|Primary|Plasma Amprenavir (APV) AUC (0-tau[τ])|"Plasma samples were assayed for APV concentrations using a validated assay. The GlaxoSmithKline (GSK) Department of Clinical Pharmacology Modeling and Simulation conducted pharmacokinetic (PK) analysis of the plasma APV concentration-time data using a model-independent approach. As a measure of total drug exposure, the area under the plasma-concentration-versus-time curve over the dosing interval at steady-state (AUC[0-τ]), where τ is the length of the dosing interval, was calculated by the linear up/log down trapezoidal method. hours, hr."|Week 48|Pharmacokinetic (PK) Population: all participants for whom serial plasma PK samples were analyzed. Only those participants contributing data were analyzed.||Hr per microgram/milliliter (hr*µg/mL)||95% Confidence Interval|Geometric Mean
701799|NCT00071799|Primary|Number of Participants Who Died|Count of participants who died during the study|42 months|Intent to treat population||participants|||Number
701800|NCT00071799|Post-Hoc|Kaplan-Meier Estimates for Median Time to Transformation to Acute Myeloid Leukemia (AML) Based on the Last Bone Marrow Assessment|A sensitivity analysis of time to transformation to AML during the entire study was performed based on the last bone marrow assessment. Patients were censored based on the last bone marrow assessment.|Day 1 (randomization) to 42 months|Intent to treat population. Participants who were transformed to AML are 78 for azacitidine and 71 for conventional care. Remaining participants were censored based on the last bone marrow assessment.||months||95% Confidence Interval|Median
701801|NCT00071799|Secondary|Number of Participants in Different Categories of Adverse Experiences During Core Study Period|Patient counts for a variety of subsets of adverse experiences for the core study period (day 1 to 42 months). The individual options for Conventional Care Regimens (Best Supportive Care Only, Low-Dose Cytarabine, and Standard Chemotherapy) are presented as separate treatments.|Day 1 (randomization) to 42 months|Safety population excludes 4 Azacitidine patients, 3 Best Supportive Care Only patients, 5 Low-dose Cytarabine patients, and 6 Standard Chemotherapy patients who were randomized/assigned to those regimens but did not receive treatment.||participants|||Number
701802|NCT00071799|Secondary|Number of Infections Per Treatment Year Requiring Intravenous Antibiotics, Antifungals or Antivirals|The on-treatment adverse event rate of infection requiring IV antibiotics, antifungals, or antivirals per patient-years. The on-treatment period was considered the period from the date of randomization to the last treatment study visit.|Day 1 (randomization) to 42 months|Intent to treat population||infections per treatment year|||Number
701803|NCT00071799|Secondary|Duration of Any Hematologic Improvement|The duration of improvement was defined as the time from the date of hematologic improvement until the date of first documented progression or relapse after hematologic improvement or death from any cause.|Day 1 (randomization) to 42 months|Intent to treat population. Participants showing hematologic improvement were 48 in azacitidine and 31 in conventional care.||months||95% Confidence Interval|Median
701804|NCT00071799|Secondary|Time to Disease Progression, Relapse After Complete or Partial Remission, or Death From Any Cause|The time to disease progression, relapse after complete or partial remission (CR, PR), or death from any cause was defined as the time from the date of randomization until the first date of documented disease progression, relapse after CR or PR, or death from any cause.|Day 1 (randomization) to 42 months|Intent to treat population. The number of participants with disease progression, relapse after remission or death from any cause is 84 for azacitidine and 79 for conventional care. Remaining participants were censored.||months||95% Confidence Interval|Median
702588|NCT00084084|Secondary|Pharmacokinetics - Area Under the Serum Concentration-Time Curve (AUC0-∞)|AUC0-∞ is a measure of the total exposure to a drug.|341 weeks|PK Population: All patients who received at least 1 dose of Replagal (RB or AF) and had at least 1 PK sample drawn.||min·U/mL||Standard Deviation|Mean
701805|NCT00071799|Secondary|Number of Participants Showing Hematologic Improvement Using International Working Group (IWG 2000) Criteria for Myelodysplastic Syndrome (MDS) Assessed by Independent Review Committee|"IWG 2000 Criteria: Pretreatment=hemoglobin <100g/L or RBC transfusion-dependent, platelet count <100x10^9/L or platelet transfusion dependent, absolute neutrophil count <1.5x10^9/L.
Erythroid response: Major->20g/L increase or transfusion independent. Minor- 10-20g/L increase or >=50% decrease in transfusion requirements.
Platelet response: Major-absolute increase of >=30x10^9/L or platelet transfusion independence. Minor->=50% increase.
Neutrophil response: Major->=100% increase or an absolute increase of >0.5x10^9/L. Minor->=100% increase and absolute increase of <0.5x10^9/L."|Day 1 to 42 months|Intent to treat population.||participants|||Number
701806|NCT00071799|Secondary|Number of Participants Considered Hematologic Responders by Investigator Determinations Using International Working Group (IWG 2000) Criteria for Myelodysplastic Syndrome (MDS)|"Investigator determined responses followed IWG criteria for
complete remission(CR): repeat bone marrow show <5% myeloblasts, and peripheral blood evaluations lasting >=2 months of hemoglobin(>110 g/L), neutrophils(>=1.5x10^9/L), platelets(>=100x10^9/L), blasts (0%) and no dysplasia
partial remission(PR) is the same as CR for peripheral blood: bone marrow shows blasts decrease by >=50% or a less advanced FAB classification from pretreatment
stable disease(SD) is a failure to achieve at least a partial remission, but with no evidence of progression for at least 2 months."|Day 1 to 42 months|Intent to treat population.||participants|||Number
701807|NCT00071799|Secondary|Summary of Participants' Platelet Transfusion Status for Participants Who Were Transfusion Independent at Baseline|Summary of dependence and independence from platelet transfusion at baseline and during treatment for patients who were independent at baseline. A patient was considered transfusion independent at baseline if the patient had no transfusions during the 56 days prior to randomization. During study, a patient was considered transfusion independent during the on-treatment period if the patient had no transfusions during any 56 consecutive days or more. Otherwise, the patient was considered transfusion dependent.|Day 1 (randomization) to 42 months|Intent to treat population||participants|||Number
701808|NCT00071799|Secondary|Summary of Participants' Platelet Transfusion Status for Participants Who Were Transfusion Dependent at Baseline|Summary of dependence and independence from platelet transfusion at baseline and during treatment for patients who were dependent at baseline. A patient was considered transfusion independent at baseline if the patient had no transfusions during the 56 days prior to randomization. During study, a patient was considered transfusion independent during the on-treatment period if the patient had no transfusions during any 56 consecutive days or more. Otherwise, the patient was considered transfusion dependent.|Day 1 (randomization) to 42 months|Intent to treat population||participants|||Number
701809|NCT00071799|Secondary|Summary of Participants' Red Blood Cell (RBC) Transfusion Status for Participants Who Were Transfusion Independent at Baseline|Summary of dependence and independence from red blood cell (RBC) transfusion at baseline and during treatment, for patients who were independent at baseline. A patient was considered transfusion independent at baseline if the patient had no transfusions during the 56 days prior to randomization. During study, a patient was considered transfusion independent during the on-treatment period if the patient had no transfusions during any 56 consecutive days or more. Otherwise, the patient was considered transfusion dependent.|Day 1 (randomization) to 42 months|Intent to treat population||participants|||Number
701810|NCT00071799|Secondary|Summary of Participants' Red Blood Cell (RBC) Transfusion Status for Participants Who Were Transfusion Dependent at Baseline|Summary of dependence and independence from red blood cell (RBC) transfusion at baseline and during treatment, for patients who were dependent at baseline. A patient was considered transfusion independent at baseline if the patient had no transfusions during the 56 days prior to randomization. During study, a patient was considered transfusion independent during the on-treatment period if the patient had no transfusions during any 56 consecutive days or more. Otherwise, the patient was considered transfusion dependent.|Day 1 (randomization) to 42 months|Intent to treat population||participants|||Number
701811|NCT00071799|Secondary|Kaplan-Meier Estimates for Median Time to Transformation to Acute Myeloid Leukemia (AML)|The time to transformation to AML was defined as the number of days from the date of randomization until the date of documented AML transformation, defined as a bone marrow blast count ≥ 30% independent of baseline bone marrow count. Patients who did not transform to AML were censored at the date of last follow-up or date of death.|Day 1 (randomization) to 42 months|Intent to treat population. Participants who were transformed to AML are 78 for azacitidine and 71 for conventional care. Remaining participants were censored based on the last bone marrow assessment.||months||95% Confidence Interval|Median
701812|NCT00071799|Secondary|Kaplan-Meier Estimate for Median Time to Transformation to Acute Myeloid Leukemia (AML) or Death From Any Cause, Whichever Occurred First|The time to transformation to AML or death from any cause (whichever occurred first) was defined as the number of days from the date of randomization until the date of documented AML transformation or death from any cause. Patients who did not transform to AML or die were censored at the date of last follow-up.|Day 1 (randomization) to 42 months|Intent to treat population. Participants who either transformed to AML or died are 120 for azacitidine and 132 for conventional care. Remaining participants were censored.||months||95% Confidence Interval|Median
701813|NCT00071799|Primary|Summary of Subgroup Analyses for Kaplan-Meier Estimates for Time to Death From Any Cause|"Kaplan-Meier estimates for the median months until death from any cause within the intent-to-treat population. Patients surviving at the end of the follow-up period were censored at the date of last contact. If a patient withdrew consent to follow-up or was lost to follow-up, the patient was censored as of the last date of contact.
Subgroups that were analyzed are age, gender, French-American-British (FAB) classification, World Health Organization (WHO) classification and International Prognostic Scoring System (IPSS) classification."|Day 1 (randomization) to 42 months|Intent to treat population. Includes participants who died and those who were censored.||months|||Number
701814|NCT00071799|Primary|Kaplan-Meier Estimates for Median Time to Death From Any Cause|Kaplan-Meier estimates for the median months until death from any cause within the intent-to-treat population. Patients surviving at the end of the follow-up period were censored at the date of last contact. If a patient withdrew consent to follow-up or was lost to follow-up, the patient was censored as of the last date of contact.|Day 1 (randomization) to 42 months|Intent to treat population. Includes participants who died and participants who were censored.||months|||Number
701816|NCT00071812|Secondary|Mean Change in Modified Total Sharp Score at Week 24|The modified total Sharp score method was used to evaluate radiographs of hands/wrists for erosions (ERO) and joint space narrowing (JSN). The total modified Sharp score ranges from 0 (no radiographic damage) to 200 (worst possible radiographic damage) and is the sum of the normalized ERO score (range 0-100) and the normalized JSN score (range 0-100). Higher scores indicated more damage.|Baseline, 24 weeks|Analysis was performed on a MITT population, defined as all patients who were randomized and received at least 1 dose of study agent and who had both a modified total Sharp score at baseline and at Week 24.||scores on a scale||Standard Error|Mean
701817|NCT00071812|Secondary|Time to First DAS28 Response|DAS28 response is defined as the time from the first dose to the first time at which a patient exhibited a “good” or a “moderate” improvement in RA disease activity, based on DAS28 improvements compared to baseline. Good response was defined as >1.2 change from baseline and DAS28 score ≤ 3.2. No response was defined as ≤ 0.6 change from baseline in DAS28 score or change between ≤ 1.2 and > 0.6 with a DAS28 score of > 5.1.|0 to 24 weeks|Analysis was performed on a MITT population, defined as all patients who were randomized and received at least 1 dose of study agent.||days||Full Range|Median
701818|NCT00071812|Secondary|Mean Change in Disease Activity Score 28 (DAS28) at Week 24|DAS is a composite index of a patient's level of RA disease activity. DAS28 is an abbreviated version of DAS, using a subset of 28 joints in the assessment, calculated based on 4 variables: 1) number of tender joints out of a total of 28 joints, 2) number of swollen joints out of a total of 28 joints, 3) ESR, 4) patient's global assessment of disease activity based on a 100-mm visual analog scale. The calculation provides a number on a scale from 0 to 10 (>5.1=active disease; <3.2=well controlled disease; <2.6=remission). Change from baseline >1.2 = good response and ≤0.6 = non-response.|Baseline, 24 weeks|Analysis was performed on a MITT population, defined as all patients who were randomized and received at least 1 dose of study agent and who had both a baseline and a Week 24 DAS28 score.||scores on a scale||Standard Error|Mean
701819|NCT00071812|Secondary|Time to First ACR70 Response, Based on ESR|Measure not posted because time to ACR70 response was unable to be determined due to the small number of patients achieving an ACR70 response in the study.|0 to 24 weeks||||||
701820|NCT00071812|Secondary|Time to First ACR50 Response, Based on ESR|Measure not posted because time to ACR50 response was unable to be determined due to the small number of patients achieving an ACR50 response in the study.|0 to 24 weeks||||||
701821|NCT00071812|Secondary|Time to First ACR20 Response, Based on ESR|The time to first ACR20 response (based on ESR) is defined as the time from the first dose to the first visit at which a patient first exhibited an ACR20 response, which may or may not have been sustained through Week 24.|0 to 24 weeks|Analysis was performed on a MITT population, defined as all patients who were randomized and received at least 1 dose of study agent.||days||Inter-Quartile Range|Median
701822|NCT00071812|Secondary|Percentage of Patients With an ACR70 Response at Week 24, Based on ESR|An ACR70 response is defined as having at least a 70% improvement in tender and swollen joints as well as a 70% improvement in 3 of 5 other criteria (patient assessment, physician assessment, pain scale, disability/functional questionnaire, and acute phase reactant value based on erythrocyte sedimentation rate [ESR]).|Baseline, 24 weeks|Analysis was performed on a MITT population, defined as all patients who were randomized and received at least 1 dose of study agent.||percentage of participants|||Number
701823|NCT00071812|Secondary|Percentage of Patients With an ACR50 Response at Week 24, Based on ESR|An ACR50 response is defined as having at least a 50% improvement in tender and swollen joints as well as a 50% improvement in 3 of 5 other criteria (patient assessment, physician assessment, pain scale, disability/functional questionnaire, and acute phase reactant value based on erythrocyte sedimentation rate [ESR]).|Baseline, 24 weeks|Analysis was performed on a MITT population, defined as all patients who were randomized and received at least 1 dose of study agent.||percentage of participants|||Number
701824|NCT00071812|Primary|Percentage of Patients With ACR20 (American College of Rheumatology) Response at Week 24, Based on Erythrocyte Sedimentation Rate (ESR)|An ACR20 response is defined as having at least a 20% improvement in tender and swollen joints as well as a 20% improvement in 3 of 5 other criteria (patient assessment, physician assessment, pain scale, disability/functional questionnaire, and acute phase reactant value based on erythrocyte sedimentation rate [ESR]).|Baseline, 24 weeks|Analysis was performed on a modified intention-to-treat (MITT) population, defined as all patients who were randomized and received at least 1 dose of study agent.||percentage of participants|||Number
701825|NCT00071890|Secondary|AIDS Events|AIDS defined events according to CDC classification|Overall study|"IL-2 arm : Oesophageal candidasis at W196
Control arm :Ocular B-cell lymphoma at W43,Oesophageal candidasis at W82, B-cell lymphoma at W104"||event|||Number
701826|NCT00071890|Secondary|Changes in CD4 Counts at Week 72||week 72|||cells per mm3||Inter-Quartile Range|Median
701827|NCT00071890|Primary|Proportion of Patients Without Failure of Strategy From Week 0 to Week 72|"A failure of strategy is defined on the first occurrence of one of the following events:
CD4 T-lymphocyte count becomes < 350 cells/mm3 between Wk0 and Wk72 (count confirmed by a 2nd measurement after 2-4 weeks
Planned interruption of therapy at Wk24 cannot be done for any reason;
Anti-retroviral treatment is restarted between Wk24 and Wk72 for any reason
Subject experiences clinical progression of HIV infection to a stage C AIDS diagnosis (appendix I)
Subject expires between Wk0 and Wk72 (whatever the cause of death)
Subject is lost to follow up"|week 72|Intent to treat analysis, missing = failure.||Pourcentage||95% Confidence Interval|Number
701828|NCT00071981|Secondary|Median Overall Survival (OS)|OS was defined as the time from registration to death from any cause.|assessed every 3 month within 2 years and every 6 months betwen 2 and 5 years|148 eligible and treated patients were included in the analysis||months||95% Confidence Interval|Median
701829|NCT00071981|Secondary|Objective Response Rate|Tumor response was assessed via Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Objective response rate is calculated as the number of patients with complete response (disappearance of all lesions) or partial response () divided by total number of evaluable patients.|Tumor response was assessed in weeks 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, and 6 months after last vaccination|148 eligible and treated patients were included in the analysis||percentage of participants||95% Confidence Interval|Number
701847|NCT00064701|Secondary|Number of Participants Experiencing Multiple Rejection Episodes|This analysis includes rejection episodes that were either confirmed by biopsy by the clinical site pathologist or were clinically treated.|one year|The number of participants analyzed represents the full analysis set.||participants|||Number
701831|NCT00071981|Secondary|Helper T-cells Response to 6MHP|Helper T cell response was evaluated by tritiated thymidine proliferation assay with fresh/cryopreserved PBL in the presence of each of the helper peptides.|Immune response was assessed at pre-registration, in weeks 1,3,5,7,8|128 eligible and treated patients who had data about helper T cell response were included in the analysis||percentage of participants||95% Confidence Interval|Number
701832|NCT00071981|Primary|Cytotoxic T-cell Lymphocytes (CTL) Response Rate|Assessment of CTL response was based on a fold-increase in T cell response measure by interferon-gamma ELIspot assay.|Immune response was assessed at pre-registrtion, in weeks 1, 3, 5, 7, 8|140 eligible and treated patients who had CTL response data were included in the analysis||percentage of participants||95% Confidence Interval|Number
701833|NCT00072176|Primary|Progression-free Survival (Tumor Progression)|Time to tumor progression or death|5 years|All patients who were evaluable for response||months||95% Confidence Interval|Median
701834|NCT00072176|Primary|Objective Clinical Response Rate|Defined as proportion of patients with 30% decrease in the sum of the longest diameters of the target lesions (partial response) maintained for at least 4 weeks, or complete disappearance of disease and cancer related symptoms (complete response) and confirmed on independent radiology review.|Up to 5 years|Patients who were evaluable for response.||percentage of patients with response||95% Confidence Interval|Number
701835|NCT00072189|Secondary|Progression-free Survival|"Estimated using the product-limit method of Kaplan and Meier.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions."|From the date of study registration to the first documentation of progressive tumor, assessed up to 7 years|||months||95% Confidence Interval|Median
701836|NCT00072189|Secondary|Overall Survival|Estimated using the product-limit method of Kaplan and Meier.|Up to 7 years|||months||95% Confidence Interval|Median
701837|NCT00072189|Primary|Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Up to 7 years|||percentage of responding participants|||Number
701838|NCT00064662|Primary|24 Month Cumulative Stress Specific Success Rates Computed From Kaplan Meier Time-to-event Analysis (Reported as % Success)|Stress-specific success defined by composite measure including: no self-reported symptoms of stress incontinence reported on the Medical, Epidemiologic, and Social Aspects of Aging Project (MESA) questionnaire , negative results (no leakage) on a provocative stress test at standardized bladder volume and no retreatment for stress incontinence Additional treatment for SUI includes anti-incontinence surgery, tightening of sling, collagen injections, medication, behavioral treatment, or devices specifically for the treatment of SUI.|Two years|All participants randomized were included in time to event analysis||% stress-specific success at 24 m||95% Confidence Interval|Number
701839|NCT00064662|Primary|24 Month Cumulative Success Rate Computed From Kaplan Meier Time-to-event Analysis (Reported as Percent Success).|Success defined as composite measure including: no self-reported incontinence symptoms reported on the Medical, Epidemiologic, and Social Aspects of Aging Project (MESA) questionnaire, <15g in pad weight during 24 hr pad test, no incontinence episodes on 3-day voiding diary, negative results (no leakage) on provocative stress test at standardized bladder volume, no retreatment for urinary incontinence. Additional treatment for stress urinary incontinence (SUI) includes anti-incontinence surgery, tightening of sling, collagen injections, medication, behavioral treatment, or devices specifically for the treatment of SUI.|Two years|All participants randomized were included in time to event analysis.||% success at 24 months||95% Confidence Interval|Number
701840|NCT00064701|Secondary|Kaplan-Meier Estimate of Graft Survival at the End of the Study|"Graft survival was defined as any participant who did not meet the definition of graft loss, where graft loss was any retransplant or the permanent return to dialysis (more than 30 days) or patient death.
Graft survival was censored at the time of last follow-up contact."|End of study (maximum time on study was 1,941 days).|The number of participants analyzed represents the full analysis set.||percentage of participants||95% Confidence Interval|Number
701841|NCT00064701|Secondary|Kaplan-Meier Estimate of Patient Survival at the End of the Study|Patient survival was defined as any participant who was alive at the end of the study. Patient survival was censored at the time of last follow-up contact.|End of study (maximum time on study was 1,941 days).|The number of participants analyzed represents the full analysis set.||percentage of participants||95% Confidence Interval|Number
701842|NCT00064701|Secondary|Change From Month 1 in Creatinine Clearance at Month 6 and Month 12|Renal function was assessed by creatinine clearance, calculated using the Cockcroft-Gault formula.|Month 1, Month 6, and Month 12|The number of participants analyzed represents the full analysis set with available data at Month 1 and at each time point.||mL/min||Standard Deviation|Mean
701843|NCT00064701|Secondary|Change From Month 1 in Serum Creatinine at Month 6 and Month 12|Renal function was assessed by the change from Month 1 in serum creatinine six months and 12 months after transplant.|Month 1, Month 6, and Month 12|The number of participants analyzed represents the full analysis set with available data at Month 1 and at each time point.||mg/dL||Standard Deviation|Mean
701844|NCT00064701|Secondary|Number of Participants Who Crossed Over Due to Treatment Failure|Participants were allowed to cross over to an alternative primary immunosuppressive regimen (either to the tacrolimus or cyclosporine treatment arms) to address an adverse event which led to randomized study drug discontinuation or in the case of severe or refractory rejection. Crossover to the modified release tacrolimus treatment arm was not permitted.|one year|The number of participants analyzed represents the full analysis set.||participants|||Number
701845|NCT00064701|Secondary|Number of Participants With Treatment Failure|Treatment failure was defined as the discontinuation of randomized study drug for any reason. Participants who met the definition of treatment failure were to be followed throughout the 12-month treatment period.|one year|The number of participants analyzed represents the full analysis set.||participants|||Number
701846|NCT00064701|Secondary|Number of Participants With Clinically Treated Acute Rejection Episodes|A clinically treated acute rejection episode was any biopsy-confirmed or suspected rejection episode that was treated with immunosuppressive therapy.|one year|The number of participants analyzed represents the full analysis set.||participants|||Number
701848|NCT00064701|Secondary|Severity of Acute Rejection|"Rejection episodes were confirmed by biopsy by the clinical site pathologist. Biopsies were graded according to the 1997 Banff criteria:
Borderline: No intimal arteritis present but foci of mild tubulitis; Grade IA: Significant interstitial infiltration and foci of moderate tubulitis; Grade IB: Significant interstitial infiltration and foci of severe tubulitis; Grade IIA: Mild to moderate intimal arteritis in at least 1 arterial cross section Grade IIB: Severe intimal arteritis comprising >25% of the luminal area lost in at least 1 arterial cross section; Grade III: Transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic infiltrate in vessel."|one year|The number of participants analyzed represents the full analysis set with a biopsy-confirmed acute rejection episode during one year.||participants|||Number
701849|NCT00064701|Secondary|Number of Participants Requiring Anti-lymphocyte Antibody Therapy for Treatment of Rejection|"Rejection episodes were confirmed by biopsy by the clinical site pathologist. Participants with histologically-proven Banff Grade II or III rejection or participants with steroid-resistant rejection were treated with anti-lymphocyte antibody treatment according to institutional practice.
Biopsies were graded according to the 1997 Banff criteria:
Borderline: No intimal arteritis present but foci of mild tubulitis; Grade I: Significant interstitial infiltration and foci of moderate to severe tubulitis; Grade II: Mild to severe intimal arteritis Grade III: Transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic infiltrate in vessel."|one year|The number of participants analyzed represents the full analysis set.||participants|||Number
701850|NCT00064701|Secondary|Time to First Biopsy-confirmed Acute Rejection Episode|"Time to first biopsy-confirmed acute rejection episode defined as the number of days from skin closure (Day 0) to the date of biopsy. Rejection episodes were confirmed by biopsy by the clinical site pathologist and graded according to the 1997 Banff criteria:
Borderline: No intimal arteritis present but foci of mild tubulitis; Grade I: Significant interstitial infiltration and foci of moderate to severe tubulitis; Grade II: Mild to severe intimal arteritis Grade III: Transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic infiltrate in vessel.
Acute rejection is defined as a grade ≥ I."|one year|The number of participants analyzed represents the full analysis set.||days||Full Range|Median
701851|NCT00064701|Secondary|Percentage of Participants With Biopsy Confirmed Acute Rejection at 6 and 12 Months|"Rejection episodes were confirmed by biopsy by the clinical site pathologist. Biopsies were graded according to the 1997 Banff criteria:
Borderline: No intimal arteritis present but foci of mild tubulitis; Grade I: Significant interstitial infiltration and foci of moderate to severe tubulitis; Grade II: Mild to severe intimal arteritis Grade III: Transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic infiltrate in vessel.
Acute rejection is defined as a grade ≥ I."|Six months and 12 months|The number of participants analyzed represents the full analysis set.||percentage of participants|||Number
701852|NCT00064701|Secondary|Graft Survival at One Year|"Graft survival defined as any participant who did not meet the criteria for graft loss, where graft loss is defined as any re-transplant, permanent return to dialysis (> 30 days), patient death, or participant whose outcome at one year was unknown.
Participants were only counted once regardless of how many criteria were met."|One year|The number of participants analyzed represents the full analysis set.||percentage of participants|||Number
701853|NCT00064701|Secondary|Patient Survival at One Year|Patient survival is defined as any participant who is known to be alive one year after the skin closure date. Participants who died or whose outcome was unknown at one year were considered to be non-survivors.|One year|The number of participants analyzed represents the full analysis set.||percentage of participants|||Number
701854|NCT00064701|Primary|Percentage of Participants With Efficacy Failure|"Efficacy failure is defined as any participant who died, experienced a graft failure (permanent return to dialysis [> 30 days] or retransplant), had a biopsy-confirmed (Banff Grade ≥ I) acute rejection (BCAR), or was lost to follow-up.
Biopsies were graded according to the 1997 Banff criteria:
Borderline: No intimal arteritis present but foci of mild tubulitis; Grade I: Significant interstitial infiltration and foci of moderate to severe tubulitis; Grade II: Mild to severe intimal arteritis Grade III: Transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic infiltrate in vessel."|one year|The number of participants analyzed represents the full analysis set, defined as all randomized patients who received at least one dose of study drug.||percentage of participants|||Number
701868|NCT00064792|Primary|Serum Cholesterol to Total Sterol Ratio|Total serum cholesterol (mg/dL) divided by the sum of all sterols (cholesterol plus its precursors, 7-dehydrocholesterol - 7DHC, and 8-dehydrocholesterol- 8DHC - in mg/dL).|1 year after therapy.|The number of participants was determined by the total number of participants to complete both phases of the trial (n=18).||percent total cholesterol||Standard Deviation|Mean
701869|NCT00064844|Primary|12 Month Smoking Abstinence|Percentage of participants with prolonged carbon monoxide verified smoking abstinence|12 months after smoking quit date|||percentage of participants abstinent|||Number
701870|NCT00064844|Primary|6 Month Smoking Abstinence|Percentage of participants with prolonged carbon monoxide verified smoking abstinence|6 months after smoking quit date|||percentage of participants abstinent|||Number
701871|NCT00072280|Primary|"Failure-free Survival (FFS) in Chemotherapy Plus Possible Surgery Arm"|Failure is defined as the occurrence of one of the following: disease progression, defined as at least a 20% increase in the disease measurement, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions; relapse (defined with same criteria as for disease progression) after response; or death as a first event. Data will be summarized as number of eligible patients in each of the following categories at the time of data cutoff for analyses of 5-year FFS: 1)Failed; 2)Failure-free through 5 years of follow-up; 3)Failure-free until data cutoff (if less than 5 years of follow-up); 4)Withdrew from study; 5)Lost to follow-up. NOTE: Reported data are through March 2008 (see Caveats section).|Study enrollment until failure, completion of follow-up, or completion of 5-year FFS analyses (up to 5 years)|By protocol design, only eligible patients were considered in the evaluation for the primary outcome measure. One (1) patient was found ineligible, leaving two (2) for the analysis population.||participants|||Number
701872|NCT00072293|Secondary|Site of Recurrence|Site of recurrence of breast cancer|Reported after a median follow-up of 60 months|Intention-to-treat||participants|||Number
701873|NCT00072293|Secondary|5-year Overall Survival|Estimated percentage of patients alive and disease-free at 5 years from randomization, where overall survival is defined as the time from randomization to death of any cause.|5-year estimate reported after a median follow-up of 60 months|Intention-to-treat||percentage of participants|||Number
701874|NCT00072293|Primary|5-year Disease-Free Survival|Estimated percentage of patients alive and disease-free at 5 years from randomization, where disease-free survival is defined as the time from randomization to first evidence of invasive relapse at any site, second primary tumor (contralateral or non-breast) or death.|5-year estimate reported after a median follow-up of 60 months|Intention-to-treat||percentage of participants|||Number
701875|NCT00072449|Secondary|Toxicity|patients only received drug for 8 weeks|8 weeks - 2 cycles|||related episodes|||Number
701876|NCT00072449|Secondary|Overall Survival|survival was evaluated q 2months|47 months|||months||95% Confidence Interval|Median
701877|NCT00072449|Secondary|Progression-free Survival|pt had MRI every 3 months|pt had MRI q3months|||days||95% Confidence Interval|Median
701878|NCT00072449|Primary|Radiographic Response|it at any time point patient progresses no more scans are required, patient is off study|1 month, 2 months and then q3months|||participants|||Number
701879|NCT00072475|Primary|Time to Transformation to AML|Time to transformation to AML is defined as the time from registration to the transformation of MDS to AML or death of any cause. Participants not meeting these criteria were censored at the date of last follow-up. This outcome was estimated using the Kaplan Meier method.|Duration of study (up to 5 years)|||months||95% Confidence Interval|Median
701880|NCT00072475|Secondary|Progression-free Survival|"Progression free survival (PFS) was defined as the time from registration to progression or death of any cause. Progression free and alive patients were censored at the date of last clinical assessment. The median PFS with 95% CI was estimated using the Kaplan Meier method.
Progression is defined as
For patients with <5% bone marrow blasts: ≥50% increase in blasts to >5% blasts
For patients with 5-10% bone marrow blasts: ≥50% increase to >10% blasts
For patients with 10-19% bone marrow blasts: increase to ≥20% blasts
One or more of the following: 50% or greater decrement from maximum remission/response levels in ANC < 1.5 K/L or PLT< 100 K/L, or reduction in HGB by at least 2 g/dL or becoming transfusion dependent
Progression after HI: Includes one or more of the following
Decrement of 50% or greater from maximum response levels in ANC < 1.5 K/L or PLT < 100 K/L
Reduction in HGB concentration by at least 2 g/dL
Becoming transfusion dependent"|Duration of study (up to 5 years)|||months||95% Confidence Interval|Median
701881|NCT00072475|Secondary|Overall Survival|Overall survival (OS) as the interval from the on-study date until death. OS was estimated using the Kaplan Meier method.|Duration of study (up to 5 years)|||months||95% Confidence Interval|Median
701882|NCT00072475|Secondary|Duration of Response|"Duration of response (DOR) was defined as the time from response (complete remission, partial remission or hematologic improvement) to progression or death of any cause. Responding and alive patients were censored at the date of last follow-up. The median DOR with 95% CI was estimated using the Kaplan Meier method.
Response was measured by International Standardized Response Criteria for MDS (described in above outcome measure)."|5 yrs|Per the description, only patients who achieved a response were evaluable for this outcome.||months||95% Confidence Interval|Median
701883|NCT00072475|Primary|Number of Participants With Response|"Response was measured by International Standardized Response Criteria for MDS
Complete Response: Bone marrow showing < 5% myeloblasts with normal maturation of all cell lines; Hgb > 11 g/dL (untransfused), ANC ≥1.5 K/L, PLT ≥ 100 K/L, No blasts, no dysplasia
Partial remission: All of the CR criteria (if abnormal at baseline), except BM evaluation. Blasts decreased by ≥ 50% over baseline. Cellularity and morphology are not relevant.
Hematologic improvement:
Erythroid (HI-E): For participants with baseline HGB < 11g/dL, Major: > 2g/dL increase, transfusion independence. Minor: 1-2g/dL increase, ≥ 50% decrease in transfusion requirements
Platelet (HI-P): For participants with baseline PLT < 100 K/L: Major: absolute increase of > 30 K/L, transfusion independence. Minor: ≥ 50% increase (net increase of >10 K/L)
Neutrophil (HI-N): For participants with baseline ANC < 1.5 K/L, Major: > 100% increase (net increase > 0.5 K/L). Minor: > 100% increase (absolute increase < 0.5 K/L)"|Duration of study (up to 5 years)|||participants|||Number
701884|NCT00072514|Secondary|Peripheral Blood Stem Cell Collection|Count of patients that attempted and had successful autologous peripheral blood stem cell (PBSC) collection.|Up to 12 weeks|Successful PBSC collection is only considered in those patients that attempted PBSC collection.||Participants|||Count of Participants
701886|NCT00072514|Secondary|Overall and Complete Response Rates|Response was assessed per standard criteria (Cheson BD, Horning SJ, Coiffier B, et al. Report of an international workshop to standardize response criteria fornon-Hodgkin’s lymphomas. J Clin Oncol 1999;17:1244–1253.)|3-4 weeks after completion of study treatment|||percentage of participants||95% Confidence Interval|Number
701887|NCT00072514|Primary|Ability to Successfully Deliver the Investigational Therapy Without Incurring the Protocol Suspension Rules|Count of participants that received the investigational therapy without incurring the protocol suspension rules. A stopping rule for safety was employed such that the study would be suspended if sufficient evidence indicated that the true grade 4-5 non-hematologic toxicity rate exceeded 10%.|At 3-4 weeks after completion of study treatment|||Participants|||Count of Participants
701888|NCT00072566|Secondary|Median Overall Survival|Calculated using the method of Kaplan-Meier.|Time from first day of treatment to time of death due to any cause, assessed up to 3 years|||months||95% Confidence Interval|Median
701889|NCT00072566|Secondary|Response Rate Based on the RECIST|Percentage of patients with a confirmed partial or complete response using RECIST v1.0 criteria. Complete response was defined as the disapperance of all target and nontarget lesions, no evidence of new lesions and normalization of CA-125; Partial response was defined as a 30% or greater reduction in the sum of the longest dimensions of all target lesions and no unequivocal progression of nontarget lesions, lasting at least 4 weeks.|Up to 3 years|||percentage of responding patients|||Number
701890|NCT00072566|Primary|Median Time to Progression|Time from treatment initiation to disease progresion calculated using the method of Kaplan-Meier. RECIST v1.0 was used to evaluate response. Progression was defined as a 20% or greater increase in the sums of the longest dimensions of target lesions, or the appearance of new lesions within 8 weeks of study entry.|Up to 3 years|||months||95% Confidence Interval|Median
701891|NCT00073307|Secondary|Health-related Quality of Life (HRQOL) by Physical Well-Being (PWB) Score of the FACT-G (Functional Assessment of Cancer Therapy-General Version) Assessment|"Primary Analysis for FACT-G (using PWB score) patient-reported outcome (PRO) measure defined as longitudinal analysis of mean score over the first 5 treatment cycles. FACT-G (PWB score) patient responses for each question range from 0=not at all to 4=very much and after reverse coding the total FACT-G (PWB score) range of values is from 0 to 28; higher score represents better HRQOL."|From start of randomization of the first subject (1Dec2003) until the data cut-off (31May2005), approximately 18 months later, PRO data collected at Day 1 of each cycle and end of treatment.|Evaluations based on ITT population with a PRO assessment. Day 1, Cycle 1 served as baseline assessment.||Scores on a scale||Standard Error|Least Squares Mean
701892|NCT00073307|Secondary|Health-related Quality of Life (HRQOL) by FKSI-10 (Functional Assessment of General Therapy Kidney Symptom Index 10) Assessment|"Primary Analysis for FKSI-10 patient-reported outcome (PRO) measure defined as longitudinal analysis of mean score over the first 5 treatment cycles. FKSI-10 patient responses for each question range from 0=not at all to 4=very much and after reverse coding the range of values for FKSI-10 total score is from 0 to 40; higher score represents better HRQOL."|From start of randomization of the first subject (1Dec2003) until the data cut-off (31May2005), approximately 18 months later, PRO data collected at Day 1 of each cycle and end of treatment.|Evaluations based on ITT population with a PRO assessment. Day 1, Cycle 1 served as baseline assessment.||Scores on a scale||Standard Error|Least Squares Mean
701893|NCT00073307|Secondary|Best Overall Response - Independent Radiological Review|Best overall response was determined according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.0 by independent radiologic review. Categories: complete response (CR, tumor disappears), partial response (PR, sum of lesion sizes decreased), stable disease (SD, steady state of disease), progressive disease (PD, sum of lesion sizes increased) and not evaluated.|From start of randomization of the first subject (1Dec2003) until the data cut-off (28Jan2005), approximately 14 months later, tumors assessed every 8 weeks.|Evaluations of best overall response based on the valid for response population, where as per protocol, subjects were to have first post-baseline tumor evaluation performed at the end of Cycle 1 (6 weeks post-randomization). Of the ITT population that met this criteria as of the 28Jan2005 data cut, 672 subjects were valid for response.||percentage of participants|||Number
701894|NCT00073307|Secondary|Final Progression-Free Survival (PFS) - Independent Radiological Review|PFS determined as the time (days) from the date of randomization at start of study to the actual date of disease progression (PD) (radiological or clinical) or death due to any cause, if death occurred before PD. Outcome measure was assessed approximately every 8 weeks using RECIST v1.0 criteria by independent radiologic review. Radiological PD defined as at least 20% increase in sum of longest diameter (LD) of measured lesions taking as reference smallest sum LD recorded since treatment started or appearance of new lesions.|From start of randomization of the first subject (1Dec2003) until the data cut-off (28Jan2005), approximately 14 months later, tumors assessed every 8 weeks.|Evaluations based on ITT population as of 28Jan2005 data cut; 769 subjects randomized at that time. PFS determined as time from randomization to actual date of disease progression (PD) (radiological or clinical) or death, if death occurred before PD. Subjects without PD or death at time of analysis were censored at last date of tumor assessment.||days||95% Confidence Interval|Median
701895|NCT00073307|Primary|Final Overall Survival - Secondary Analysis (Placebo Data Censored at 30June2005) in the ITT Population|Overall survival determined as the time (days) from the date of randomization at start of study to the date of death, due to any cause. Outcome measure was assessed regularly, i.e. every 3 weeks for the first 24 weeks during treatment and every 4 weeks thereafter and approximately every 3 months during post-treatment.|From start of randomization of the first subject (1Dec2003) until the data cut-off (8Sep2006) for the final OS analysis, approximately 33 months later|Evaluations based on ITT population. Subjects alive at time of analysis were censored at last date of FU (last visit or contact or at data cut-off date). In case of incomplete date, missing day, day 15 was used. Placebo censored at 30June2005, approximate time of crossover of placebo subjects to sorafenib. NA - not estimable due to censored data.||days||95% Confidence Interval|Median
701930|NCT00073528|Secondary|Overall Survival in the HER2-Positive Population|Overall survival was defined as the time from randomization until death due to any cause.|From date of randomization until date of death due to any cause, assessed up to 46 months|HER2-Positive Population. Only those participants who died during the study due to any cause were assessed.||weeks||95% Confidence Interval|Median
702589|NCT00084084|Primary|Patients Who Experienced At Least One Adverse Event (AE)||362 weeks|Safety Population: Patients in Cohort 1 who received at least one dose of Replagal RB in Phase 1.||participants|||Number
701896|NCT00073307|Primary|Final Overall Survival (OS) - Primary Analysis in the ITT (Intent To Treat) Population|Overall survival determined as the time (days) from the date of randomization at start of study to the date of death, due to any cause. Outcome measure was assessed regularly, i.e. every 3 weeks for the first 24 weeks during treatment and every 4 weeks thereafter and approximately every 3 months during post-treatment.|From start of randomization of the first subject (1Dec2003) until the data cut-off (8Sep2006) for the final OS analysis, approximately 33 months later|Evaluations based on ITT population. Subjects alive at time of analysis were censored at last date of follow-up (FU) (last visit or contact or at data cut-off date). In case of incomplete date, day was missing, day 15 was used.||days||95% Confidence Interval|Median
701897|NCT00073333|Primary|Social Phobia Remission Rate at 6 Month Follow-up|Lack of SocialPhobia Diagnosis at 6 month follow-up|6 month follow up|||participants|||Number
701898|NCT00073333|Secondary|Score on the SPAI||Measured at Month 12||||||
701899|NCT00073333|Primary|Social Phobia Remission||Measured at Month 12||||||
701900|NCT00073528|Secondary|Number of Participants With the Indicated Expression of Tumor by Epidermal Growth Factor Receptor (ErbB1/HER1/EGFR) at Baseline|EGFR is a cell surface receptor tyrosine kinase expressed in certain types of tumors. Depending upon the staining intensity, EGFR was graded as follows: 0=absence of membrane staining above background in all tumor cells; EGFR-positive=staining is defined as any IHC staining of tumor cell membranes above background level, whether it is complete or incomplete circumferential staining (1+, 2+, 3+).|Baseline|ITT Population||participants|||Number
701901|NCT00073528|Secondary|Time to Seroconversion for Participants Who Were HER2 Negative at Baseline But Became HER2 Positive|Time to seroconversion was defined as the time from the date of randomization until the first instance of serum HER2 (>15 ng/mL) on two consecutive occasions.|Up to 46 months|HER2-Negative Population. Only those participants who had a HER2-negative tumor status based on baseline tissue with baseline serum HER2 ECD values =<15 ng/mL but later had at least two consecutive serum HER2 ECD values >15 ng/mL were assessed.||weeks||95% Confidence Interval|Median
701902|NCT00073528|Secondary|Number of HER2-Negative Participants at Baseline With and Without Seroconversion to a Status of HER2 Positive|Participants who had a HER2-negative tumor status based on baseline tissue with baseline serum HER2 ECD values =<15 ng/mL but later had at least two consecutive serum HER2 ECD values >15 ng/mL experienced seroconversion.|Up to 46 months|HER2-Negative Population: all randomized participants regardless of whether or not study treatment had been received and who at baseline were evaluated by the central laboratory to have retrospectively documented non-amplification or missing amplification of HER2 by FISH (<2.0) and documented IHC scores of 0, 1+, 2+, or missing in tumor tissue.||participants|||Number
701903|NCT00073528|Secondary|Number of Participants With Response in Participants With Baseline Serum HER2 Extracellular Domain (ECD) Baseline Values Greater Than 15 Nanograms Per Milliliter (ng/mL) and 15 ng/mL or Lower|The HER2 ECD is a glycoprotein that can be shed from the cell surface into the blood of normal individuals and can be elevated in different pathologic conditions. The serum HER2 ECD level generally reflects the tissue HER2 status. The HER2 ECD is quantified in serum with an enzyme-linked immunosorbent assay (ELISA). Non-Evaluable (NE): any participant who could not be classified as CR, PR, SD, or PD.|Up to 46 months|HER2-Positive Population||participants|||Number
701904|NCT00073528|Secondary|Number of Participants With Clinical Benefit Categorized by HER2 ImmunoHistoChemistry (IHC) Intensity|IHC is a commonly used test to assess the amount of the HER2 receptor protein on the surface of the cancer cells. The IHC test results in a score of 0 to 3+, which indicates the amount of HER2 receptor protein on the cells in a sample of breast cancer tissue. Tissue scores of 0 to 1+ indicate HER2 negativity; scores of 2+ and 3+ indicate HER2 positivity. Clinical benefit is defined as participants with CR, PR, or SD for =>6-month period.|Up to 46 months|ITT Population||participants|||Number
701905|NCT00073528|Secondary|Number of Participants With Clinical Benefit Categorized by HER2 Fluorescence in Situ Hybridization (FISH) Status|Clinical benefit: participants with CR, PR, or SD for =>6-month period. FISH testing measures the amount of the HER2 gene in each cell. This gene is responsible for the overproduction of the HER2 protein. FISH-positive: excessive amounts of the gene are present; FISH-negative: normal levels of the gene are present.|Up to 46 months|ITT Population||participants|||Number
701906|NCT00073528|Secondary|Number of Participants Classified as QOL Responders Based on the FACT-B, FACT-G, and TOI Total Scores|A minimally important difference (MID) is the smallest difference in a score for a measure of QOL that corresponds to a difference in function or clinical course. Responders are defined as participants with an MID => 8 for the FACT-B score, and an MID =>6 for the FACT-G and TOI scores.|Up to 46 months|HER2-Positive Population. Only those participants with a baseline score and at least one post-baseline score were assessed.||participants|||Number
701907|NCT00073528|Secondary|Adjusted Mean Change From Baseline for the Trial Outcome Index (TOI) Score Using Observed Data|The TOI score is the sum of the physical well-being, functional well-being, and breast cancer unweighted subscale scores. The total TOI score ranges from 0 to 92, with higher scores representing a better quality of life.|Week 12, 24, 36, and 48 visits; conclusion/withdrawal visit|HER2-Positive Population. Only those participants whose item response rate was greater than 80% were assessed.||scores on a scale||Standard Error|Mean
701908|NCT00073528|Secondary|Adjusted Mean Change From Baseline for the Functional Assessment of Cancer Therapy-General (FACT-G) Score Using Observed Data|FACT-G is a subscale of the FACT-B QOL questionnaire and consists of 27 questions grouped into 4 domains that measure a participant's physical, functional, social and family, and emotional well-being. FACT-G is assessed on a five-point Likert-type scale, with scores ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). The total score is calculated as the sum of the item scores on the subscale; the total ranges from 0 to 108, with higher score indicating a better quality of life.|Week 12, 24, 36, and 48 visits; conclusion/withdrawal visit|HER2-Positive Population. Only those participants whose item response rate was greater than 80% were assessed.||scores on a scale||Standard Error|Mean
701941|NCT00073983|Secondary|Time to Progression|Stable disease is measured from the start of the treatment until the criteria for disease progression are met, taking as reference the smallest measurements recorded since the treatment started. The clinical relevance of the duration of stable disease varies for different tumor types and grades. Bayesian statistical model is used. Timepoints for evaluation are post-cycle 2, 4, 8 and 12 using RECIST 1.0 criteria.|post-cycle 2, 4, 8 and 12|Analysis not completed. One patient with chondrosarcoma was ineligible due to lack of measurable disease at enrollment.||months|||Number
701909|NCT00073528|Secondary|Adjusted Mean Change From Baseline for the FACT-B Total Score Using Observed Data|Quality of Life (QOL) was assessed using the FACT-B questionnaire, which is a 37-item (27 general and 10 breast cancer-specific questions) self-reporting instrument consisting of 5 dimensions: physical-, social/family-, emotional-, functional-well being, and a breast cancer subscale. Higher scores on the FACT-B scales indicate a higher QOL; each ranging from 0 (not at all) to 4 (very much). The score is transformed for FACT-B and results in a total score ranging from 0 to 144. The FACT-B is designed to measure multidimensional QOL in participants with breast cancer.|Week 12, 24, 36, and 48 visits; conclusion/withdrawal visit|HER2-Positive Population. Only those participants whose item response rate was greater than 80% were assessed.||scores on a scale||Standard Error|Mean
701910|NCT00073528|Secondary|Number of Participants Completing the Functional Assessment of Cancer Therapy-breast (FACT-B) Questionnaire at the Scheduled Visits|Quality of Life (QOL) was assessed using the FACT-B questionnaire, which was a 37-item (27 general and 10 breast cancer-specific questions) self-reporting instrument consisting of 5 dimensions: physical-, social/family-, emotional-, functional-well being, and a breast cancer subscale. Higher scores on the FACT-B scales (each ranging from 0 [not at all] to 4 [very much]) indicate a higher QOL. The score is transformed for FACT-B and results in a total score ranging from 0 to 144. Complete: completing at least 1 question from FACT-B.|Day 1 (baseline) visit; Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192 visits; conclusion/withdrawal visit|ITT Population||participants|||Number
701911|NCT00073528|Secondary|Number of Participants With the Indicated Serious Adverse Events (SAEs) Related to Study Drug Reported by More Than One Participant in Either Treatment Arm|An SAE is any event occurring at any dose that results in any of the following: death, a life-threatening adverse drug experience (ADE; at immediate risk of death from the experience as it occurred), inpatient hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, or a congenital anomaly/birth defect. Medical events that may not result in death, be life threatening, or require hospitalization may be considered to be a serious ADEs when based upon appropriate medical judgment. Relatedness was based on the Investigator's medical judgement.|Up to 46 months|Safety Population. Only those participants who experienced SAEs related to study drug that were reported by more than one participant in either treatment arm were assessed.||participants|||Number
701912|NCT00073528|Secondary|Number of Participants With the Indicated Adverse Events (AEs) Related to Study Treatment Reported in 10% or More Participants in Either Treatment Arm|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The Investigator assessed whether the AE was possibly or probably related to study treatment.|Up to 46 months|Safety Population: all randomized participants who had received at least 1 dose of study treatment, based on the actual treatment received if this differed from that to which the participant was randomized. All participants with any AE related to study treatment were assessed.||participants|||Number
701913|NCT00073528|Secondary|TTP for Participants From the ITT Population as Assessed by the Investigator|TTP is defined as the interval between the date of randomization and the earliest date of disease progression or death due to breast cancer. Disease progression was based on the assessments by the Investigator.|Up to 46 months|ITT Population. Only those participants who experienced disease progression or died due to breast cancer were assessed.||weeks||95% Confidence Interval|Median
701914|NCT00073528|Secondary|Number of Participants With Evidence of Brain Metastases From the ITT Population|The confirmation criteria for the evidence of brain metastases was the incidence of lesions occurring within any part of the central nervous system (CNS) as evidenced by radiological scans. Metastases are defined as the spread of cancer from one part of the body to another.|Up to 46 months|ITT Population||participants|||Number
701915|NCT00073528|Secondary|Duration of Response for the Participants With CR or PR in the ITT Population as Assessed by the Investigator|Duration of response is defined as the time from the first documented evidence of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the baseline sum LD) until the first documented sign of disease progression or death due to any cause. The assessments of CR or PR required confirmation using bone scans.|Up to 46 months|ITT Population. Only those participants with CR or PR response were assessed.||weeks||Inter-Quartile Range|Median
701916|NCT00073528|Secondary|Number of Participants With the Indicated Time to Response for CR or PR in the ITT Population as Assessed by the Investigator|Time to response is defined as the time from randomization until the first documented evidence of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sume of the LD of target lesions, taking as reference the baseline sum LD) (whichever status was recorded first). The assessments of CR or PR required confirmation using bone scans.|Up to 46 months|ITT Population. Only those participants with CR or PR were assessed.||participants|||Number
701917|NCT00073528|Secondary|Clinical Benefit (CB) in the ITT Population as Assessed by the Investigator|CB is defined as the percentage of participants with evidence of confirmed CR, PR, or stable disease (SD) for at least 6 months. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the baseline sum LD. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the baseline measurement.|Up to 46 months|ITT Population||percentage of participants|||Number
701918|NCT00073528|Secondary|Number of Participants With Overall Tumor Response (OR) by Stratification Factors With Measurable Disease, Including Bone Scans, in the ITT Population as Assessed by the Investigator|Participants were stratified based on site of disease at screening (SDS) (soft tissue or visceral or bone-only disease) and prior adjuvant endocrine therapy (PAET) (discontinuation interval [DI] =>6 months or DI <6 months). OR is defined as the number of participants achieving either a confirmed CR or PR. Response was assessed via RECIST. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the baseline sum LD. DI is defined as the time period from stopping the PEAT and the randomization date.|Up to 46 months|ITT Population. Only those participants with some measurable disease were assessed. Response with bone scan confirmation was required. Participants with bone-only disease were excluded from the analysis because bone-only disease is non-measurable only per RECIST 1.0.||participants|||Number
702000|NCT00075023|Primary|Mean Percentage Change in Total Surface Area of Oral Ulceration.|Mean percentage change in total surface area of oral ulceration|baseline to 4 weeks|||percentage change||Standard Deviation|Mean
701919|NCT00073528|Secondary|Overall Tumor Response (OR) for Participants With Measurable and Non-measurable Disease, Including Bone Scans, in the ITT Population as Assessed by the Investigator|OR is defined as the percentage of participants achieving either a confirmed complete response (CR) or partial response (PR). Response was assessed via Response Evaluation criteria in Solid Tumors (RECIST). The percentage of participants with response was calculated by using the formula: 100 * (number of participants with CR + number of participants with PR)/total number of participants. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as a reference the baseline sum LD.|Up to 46 months|ITT Population. Only those participants who achieved either a confirmed CR or PR were assessed.||percentage of participants|||Number
701920|NCT00073528|Secondary|Overall Survival in the ITT Population|Overall survival was defined as the time from randomization until death due to any cause.|From date of randomization until date of death due to any cause, assessed up to 46 months|ITT Population. Only those participants who died during the study due to any cause were assessed.||weeks||95% Confidence Interval|Median
701921|NCT00073528|Secondary|Time to Progression (TTP) for the HER2-Positive Population as Assessed by the Investigator|TTP is defined as the interval between the date of randomization and the earliest date of disease progression or death due to breast cancer. Disease progression was based on the assessments by the Investigator.|Up to 46 months|HER2-Positive Population. Only those participants who experienced disease progression or died due to breast cancer were assessed.||weeks||95% Confidence Interval|Median
701922|NCT00073528|Secondary|Number of Participants With Evidence of Brain Metastases in the HER2-Positive Population|The confirmation criteria for the evidence of brain metastases was the incidence of lesions occurring within any part of the central nervous system (CNS) as evidenced by radiological scans. Metastases are defined as the spread of cancer from one part of the body to another.|Up to 46 months|HER2-Positive Population||participants|||Number
701923|NCT00073528|Secondary|Duration of Response for the Participants With CR or PR in the HER2-Positive Population as Assessed by the Investigator|Duration of response is defined as the time from the first documented evidence of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the baseline sum LD) until the first documented sign of disease progression or death due to any cause. The assessments of CR or PR required confirmation using bone scans.|Up to 46 months|HER2-Positive Population. Only those participants with CR or PR were assessed.||weeks||Inter-Quartile Range|Median
701924|NCT00073528|Secondary|Number of Participants With the Indicated Time to Response for CR or PR in the HER2-Positive Population as Assessed by the Investigator|Time to response is defined as the time from randomization until the first documented evidence of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sume of the LD of target lesions, taking as reference the baseline sum LD) (whichever status was recorded first). The assessments of CR or PR required confirmation using bone scans.|Up to 46 months|HER2-Positive Population. Only those participants with CR or PR were assessed.||participants|||Number
701925|NCT00073528|Secondary|Number of Participants With the Indicated Best Response From the Participants With Measurable and Non-measurable Disease, Including Bone Scans, in the ITT Population as Assessed by the Investigator.|CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as a reference the smallest sum LD since the baseline measurement. The best overall response is defined as the best response recorded from the start of treatment until disease progression/recurrence. PD: presence of target lesions, non-target lesions, and/or new lesions.|Up to 46 months|ITT Population||participants|||Number
701926|NCT00073528|Secondary|Number of Participants With the Indicated Best Response From the Participants With Measurable and Non-measurable Disease, Including Bone Scans, in the HER2-Positive Population as Assessed by the Investigator.|CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as a reference the smallest sum LD since the baseline measurement. The best overall response is defined as the best response recorded from the start of treatment until disease progression/recurrence. PD: presence of target lesions, non-target lesions, and/or new lesions.|Up to 46 months|HER2-Positive Population||participants|||Number
701927|NCT00073528|Secondary|Clinical Benefit (CB) in the HER2-Positive Population as Assessed by the Investigator|CB is defined as the percentage of participants with evidence of confirmed CR, PR, or stable disease (SD) for at least 6 months. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the baseline sum LD. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the baseline measurement.|Up to 46 months|HER2-Positive Population||percentage of participants|||Number
701928|NCT00073528|Secondary|Number of Participants With Overall Tumor Response (OR) by Stratification Factors With Measurable Disease, Including Bone Scans, in the HER2-Positive Population as Assessed by the Investigator|Participants were stratified based on site of disease at screening (SDS) (soft tissue or visceral or bone-only disease) and prior adjuvant endocrine therapy (PAET) (discontinuation interval [DI] =>6 months or DI <6 months). OR is defined as the number of participants achieving either a confirmed CR or PR. Response was assessed via RECIST. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the baseline sum LD. DI is defined as the time period from stopping the PEAT to the randomization date.|Up to 46 months|HER2-Positive Population. Only those participants with measurable disease, including bone scans, were assessed.||participants|||Number
701929|NCT00073528|Secondary|Overall Tumor Response (OR) for Participants With Measurable and Non-measurable Disease, Including Bone Scans, in the HER2-Positive Population as Assessed by the Investigator|OR is defined as the percentage of participants achieving either a confirmed complete response (CR) or partial response (PR). Response was assessed via Response Evaluation criteria in Solid Tumors (RECIST). The percentage of participants with response was calculated by using the formula: 100 * (number of participants with CR + number of participants with PR)/total number of participants. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as a reference the baseline sum LD.|Up to 46 months|HER2-Positive Population||percentage of participants|||Number
701931|NCT00073528|Secondary|PFS in Participants in the ITT Population as Assessed by the Investigator|PFS is defined as the time from randomization until the earliest date of disease progression or death due to any cause, if sooner. The date of documented disease progression is defined as the date of radiological disease progression as assessed by the investigator based on imaging data and also by the clinical assessment of symptomatic progression. Per RECIST 1.0, disease progression is defined as a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions.|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 46 months|ITT Population. Only those participants who experienced disease progression or died during their participation in the study were assessed.||weeks||95% Confidence Interval|Median
701932|NCT00073528|Secondary|Number of Participants With PFS in the Intent-To-Treat (ITT) Population as Assessed by the Investigator|PFS is defined as the time from randomization until the earliest date of disease progression or death due to any cause, if sooner. The date of documented disease progression is defined as the date of radiological disease progression as assessed by the investigator based on imaging data and also by the clinical assessment of symptomatic progression. Per RECIST 1.0, disease progression is defined as a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions.|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 46 months|ITT Population: all randomized participants, regardless of whether or not study treatment had been received. The ITT Population included the HER2-Positive Population, the HER2-Negative Population, and the HER2-Missing Population.||participants|||Number
701933|NCT00073528|Primary|Progression Free Survival (PFS) of Participants in the HER2-Positive Population as Assessed by the Investigator|PFS is defined as the time from randomization until the earliest date of disease progression or death due to any cause, if sooner. The date of documented disease progression is defined as the date of radiological disease progression as assessed by the investigator based on imaging data and also by the clinical assessment of symptomatic progression. Per RECIST 1.0, disease progression is defined as a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions.|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 46 months|HER2-Positive Population. Only those participants who experienced disease progression or died during their participation in the study were assessed.||weeks||95% Confidence Interval|Median
701934|NCT00073528|Primary|Number of Participants With Progression Free Survival (PFS) in the Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Her3 as Assessed by the Investigator|PFS is defined as the time from randomization until the earliest date of disease progression (PD) or death due to any cause, if sooner. The date of documented PD is defined as the date of radiological PD as assessed by the investigator based on imaging data and also by the clinical assessment of symptomatic progression. Per Response Evaluation Criteria in Solid Tumors (RECIST 1.0), PD is defined as a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as a reference the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions.|From the date of randomization until the date of the first documented progression or date of death from any cause, whichever came first, assessed for up to 46 months|HER2-Positive Population: all randomized participants who had documented amplification of baseline HER2 by fluorescence in situ hybridization (FISH) (=>2.0) or 3+ immunohistochemistry (IHC) (or 2+ IHC and FISH +) in archived tumor tissue regardless of whether or not study treatment had been received.||participants|||Number
701935|NCT00073918|Secondary|Toxicity as Assessed by Common Terminology Criteria (CTC) v 2.0|Grade 3-4 Bearman non-hematologic toxicity will be carefully monitored throughout this study. The protocol will be terminated due to safety concerns if there exists sufficient evidence suggesting that the true rate of grade 3-4 nonhematologic toxicity exceeds 25%. All patients, regardless of histology, will be evaluated together for purposes of toxicity. Sufficient evidence will be taken to be a lower limit to the appropriate 90% one-sided confidence interval in excess of 25%|From date of first exposure to study drug, through date of relapse/progression or other significant medical event confounding further assessment, assessed up to 15 years|Number of Grade 3-4 toxicities.||events|||Number
701936|NCT00073918|Secondary|Response Rate|Response rates will be estimated as the percentage of patients|From date of transplant through date of relapse/progression or death, assessed up to 15 years|Percentage of patients||percentage of participants|||Number
701937|NCT00073918|Secondary|5 Year Overall Survival|Survival will be estimated using the method of Kaplan and Meier. Associated confidence intervals will be provided as part of the analysis.|Up to 15 years|||percentage of participants|||Number
701938|NCT00073918|Primary|Progression-free Survival|Kaplan-Meier estimate of progression-free survival at 3 years will be used as the primary determinant of potential efficacy.|At year 3|||percentage of participants|||Number
701939|NCT00073983|Secondary|Pharmacokinetics of Gemcitabine Alone and Gemcitabine Followed by Docetaxel at Protocol Specified Timeframe in Participants Enrolled on Study|Blood samples for the determination of gemcitabine (and its metabolite dFdU) will be obtained prior to infusion, at 75 and 85 minutes (steady state), and 95 105 and 120 minutes, after the start of the 90 minute infusion on day 1 and day 8 of cycle 1. On day 8, docetaxel pharmacokinetics will be performed prior to infusion, 55 minutes (5 minutes prior to the end of infusion), 30 minutes post infusion, 5 hr and 24hr post infusion.|Gemcitibine: 0hr, 75, 85, 95, 105 and 120 min after the start of the 90 minute infusion; docetaxel: 0hr, 55 min, 30 min post infusion, 5hr and 24hr post infusion.|There were insufficent samples obtained to analyze pharmacokinetics.||participants|||Number
701940|NCT00073983|Secondary|Toxicity as Assessed by NCI CTCAE v3.0|Toxicity was graded according to Common Terminology Criteria for Adverse Events v.3.0 (CTCAE v.3.0). For gemcitabine or docetaxel related grade 3 or 4 non-hematological toxicities or hematological toxicities (grade 3 or 4 neutropenia for ≥ 7 days, grade 4 thrombocytopenia, or any platelet transfusion), both agents were withheld until the toxicity was ≤ grade 1. If the toxicity recovered to ≤ grade 1 by cycle day 35, the dose of both agents was reduced for all subsequent cycles. If the toxicity did not resolve by day 35, protocol therapy was discontinued.|Throughout the study|Analysis per protocol. One patient with chondrosarcoma was ineligible due to lack of measurable disease at enrollment.||participants|||Number
701942|NCT00073983|Primary|Objective Response Rate|Patients will be evaluated up to 4 time points(after 2,4,8 and 12 cycles of therapy), each cycle is 21 days. Per RECIST 1.0 and assessed by CT/MRI disease status will be categorized as R=CR/PR(response), F=progressive disease or death(failure), or S(stable disease=neither R nor F) based on the change from baseline. A patient with outcome R or F at any stage is scored as having that overall outcome, a patient with outcome S is re-evaluated after subsequent cycles of therapy. Patients who receive more than 14 cycles of therapy will be scored as the outcome at completion of cycle 14.|After 2, 4, 8 and 12 cycles of therapy, each cycle is 21 days|Analysis per protocol. One patient with chondrosarcoma was ineligible due to lack of measurable disease at enrollment.||participants|||Number
701943|NCT00074035|Secondary|Pharmacokinetics||At initiation of Tx and at 3 months||||||
701944|NCT00074035|Secondary|Overall Survival At 2 Years|Percentage of patients who were alive at 2 years.|2 year|||percentage of participants|||Number
701945|NCT00074035|Secondary|Overall Survival At 1 Year|Percentage of patients who were alive at 1 year.|1 year|||percentage of participants|||Number
701946|NCT00074035|Secondary|Grade 3 or Higher Non-hematologic Adverse Events|Number of participants experiencing a grade 3, 4 or 5 clinically significant non-hematologic adverse events, at least possibly related to treatment.|Duration of treatment (up to 5 years)|||count of participants|||Number
701947|NCT00074035|Primary|Response Rate|"Percentage of participants who had a complete or partial response defined by the Hopkins scoring system.
A complete response is defined as the disappearance of signs and symptoms of chronic GVHD in all involved systems that is sustained for at lest 4 weeks. A partial response is an improvement by 2 or more points in at least one system score, which is sustained for at least 4 weeks, with no signs of worsening in others."|3 months|3 patients died before the 3 month evaluation and were not evaluated for the primary endpoint||percentage of participants|||Number
701948|NCT00074152|Secondary|Sites of First Failures|Tumor recurrence in the breast, lymph nodes or other areas of the body including bone, lung, liver, central nervous system, bone marrow|5 years after randomization|||participants|||Number
701949|NCT00074152|Secondary|Overall Survival||5 years after randomization|||percentage of participants||95% Confidence Interval|Number
701950|NCT00074152|Primary|Disease-free Survival||5 years after randomization|||percentage of participants||95% Confidence Interval|Number
701951|NCT00074165|Secondary|Effect of Sodium Thiosulfate (STS) on Granulocytes and Erythrocytes Assessed by Complete Blood Count Lab Values Done Weekly During Treatment||2 years||||||
701952|NCT00074165|Secondary|Ototoxicity Assessed by Audiology Hearing Test Done Monthly During Treatment||2 years||||||
701953|NCT00074165|Secondary|Quality of Life Assessed by EORTC QOL Before Treatment and Then Every 3 Months||5 years||||||
701954|NCT00074165|Secondary|Progression-free Survival Assessed by Clinical and Radiographic Response From First Day of Treatment Until Tumor Progression||5 years||||||
701955|NCT00074165|Secondary|Number of Participants With Overall Survival Assessed by Clinical and Radiographic Response|Overall survival is measured from entry onto study until death from any cause or until death or progression of disease, respectively.|5 years|Inadequate sample size to determine overall survival|||||
701956|NCT00074165|Primary|Number of Participants With a Complete Response Rate to Chemotherapy Regimen Assessed by Radiographic Response at 2 Years.|Per RECIST criteria (v1.1) and assessed by magnetic resonance imaging (MRI): Complete response (CR), Disappearance of all target lesions.|2 years|||Participants|||Number
701957|NCT00074269|Secondary|Frequency and Durability of the Induction of Full Donor Chimerism of Lymphocytes as Measured at 1, 3, 6, and 12 Months Post Allografting||post treatment||||||
701958|NCT00074269|Secondary|Response (Partial and Complete) as Measured at 1, 3, 6, and 12 Months Post Allografting and Within 1 Week After the Onset of Documented GVHD if > 1 Month Separates Any of the Response Evaluation Timepoints||post treatment||||||
701959|NCT00074269|Secondary|Overall Survival||post treatment||||||
701960|NCT00074269|Secondary|Progression-free Survival||post treatment||||||
701961|NCT00074269|Primary|Incidence and Severity of Acute and Chronic Graft-versus-host Disease (GVHD)||post treatment||||||
701962|NCT00074269|Primary|Facilitation of Long-term Engraftment||post treatment||||||
701963|NCT00074269|Primary|Adverse Events Rate||5 years post transplant|||percentage of participants|||Number
701964|NCT00074412|Secondary|NVP Concentrations in Infants Determined to be HIV-infected and in a Sample of HIV-uninfected Infants|Samples for NVP concentration were selected from the Version 3.0 infants who were randomized to NVP at 6 weeks and whose mothers were not on 3 or more antiretrovirals at the time of randomization. All infants HIV-infected by 6 months who met this criteria were selected and matched to HIV-uninfected infants who also met this criteria in a 1:3 ratio. NVP concentrations were measured by high liquid chromatographic/mass spectroscopy from the aforementioned infants plasma samples collected at week 8 and month 3. Median NVP concentrations were compared|Week 8 and Month 3||||||
701965|NCT00074412|Secondary|Rates of Disease Progression as Defined by CD4 Counts, HIV-1 RNA PCR, and Mortality in Infected Infants in the Two Arms||Throughout study||||||
701966|NCT00074412|Secondary|Frequency and Duration of NVP-resistant HIV Strains in Plasma of HIV-infected Infants||Throughout study||||||
701967|NCT00074412|Secondary|Relationship Between Maternal Plasma and Breast Milk RNA Levels and the Risk of MTCT||Throughout study||||||
701968|NCT00074412|Secondary|Frequency and Duration of Maternal Plasma and Breast Milk NVP-resistant HIV Strains and the Relationship With HIV Transmission||Throughout study||||||
701969|NCT00074412|Secondary|Infant Survival Rates (Mortality Regardless of HIV Infection) in the Two Arms||At Month 18|||participants|||Number
701970|NCT00074412|Secondary|Relative Rates of HIV Infection in the Two Arms||At Month 18|A total of 1527 infants were randomized to either placebo or extended NVP. 5 of these infants were later found to be infected at the time of randomization (2 in NVP and 3 in Placebo). Thus, only 1522 infants were included in the analysis.||participants|||Number
701971|NCT00074412|Secondary|Proportion of Infants Who Are Alive and HIV-uninfected in the Two Arms||At Months 6 and 18|There were 1522 infants randomized at 6 weeks of birth to either the extended Nevirapine arm (759) or the placebo arm (763).||participants|||Number
702001|NCT00075088|Secondary|Rehospitalization and Mortality||4 years|we did not have the resources to achieve this secondary aim that required long-term follow up (a labor intensive job). The PI is now retired.|||||
701972|NCT00074412|Primary|Frequency and Severity of Adverse Reactions Among Participating Infants|For those infants who were randomized at 6 weeks and who initiated study drug we looked at the frequency and severity of adverse reactions through 18 months of study. The severity of all AEs was graded according to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. The term severity is described as the intensity grade or level for specific event (i.e. mild, moderate, severe, or life-threatening). Severity is not the same as seriousness.|6 weeks through 18 months|A total of 1519 infants, 758 in the NVP arm and 761 in the placebo arm, initiated study product and were thus included in the analysis for the frequency and severity of adverse reactions.||Number of Adverse Events|Participants||Number
701973|NCT00074412|Primary|HIV Infection in Infants Determined to be HIV Uninfected at 6 Weeks Enrolled in Each Arm of the Study||At Month 6|All infants who were randomly allocated to either treatment or placebo at 6 weeks of age under version 3.0 of the protocol were included in the analysis of the primary endpoint, HIV infection at 6 months. 127/1700 infants were enrolled but excluded from randomization at 6 weeks for various reasons as mentioned in the flow-through.||participants|||Number
701974|NCT00074581|Primary|All Partner HIV Infection Rates in Early-ART and Delayed-ART Arms|All Incident HIV infections occurring in the partners (HIV-negative at enrollment) of randomized HIV-infected index (HIV-positive at enrollment) cases are assessed, by arm.|Throughout study|Population includes all partners (HIV-negative at enrollment) of randomized HIV-infected index (HIV-positive at enrollment) cases, by arm.||event rate per 100 person-yr||95% Confidence Interval|Number
701975|NCT00074581|Primary|Linked Partner HIV Infection Rates in Early-ART and Delayed-ART Arms|incident HIV infections occurring in the partners (HIV-negative at enrollment) of randomized HIV-infected index (HIV-positive at enrollment) cases are assessed, by arm. Only acquisition from the index partner were included in the primary analysis, therefore, each endpoint was required to be confirmed (by genotyping) such that the viral envelop sequence in the index case matched that of the partner.|Throughout study|||event rate per 100 person-yr|Person Years|95% Confidence Interval|Number
701976|NCT00074711|Secondary|Change From Baseline in Urinary Hydroxyproline to Creatinine Ratio at 12 Months||Measured at baseline and 12 months|||micromol/mmol||Standard Error|Mean
701977|NCT00074711|Secondary|Change From Baseline in Urinary N-telopeptide at 12 Months||Measured at baseline and 12 months|||nmol bce/mmol||Standard Error|Mean
701978|NCT00074711|Secondary|Change From Baseline in Urinary Calcium to Creatinine Ratio, Urinary Phosphorus to Creatinine Ratio at 12 Months||Measured at baseline and 12 months|||g/g||Standard Error|Mean
701979|NCT00074711|Secondary|Change From Baseline in Serum Phosphorus, Serum Creatinine, Serum Calcium at 12 Months||Measured at baseline and 12 months|||mg/dl||Standard Error|Mean
701980|NCT00074711|Primary|Bone Mineral Density (BMD) Under Treatment With an Anabolic Agent (Teriparatide).|The principle outcome measure was change in bone mineral density (BMD) under treatment with an anabolic agent (teriparatide).|12 months|Participants that completed study.||g/cm2||Standard Error|Mean
701981|NCT00074711|Primary|Lumbar Spine and Hip BMD, Measured as Grams Per Square Centimeter.|Bone mineral density (BMD, measured by dual X-ray absorptiometry – DEXA) measured at several intervals during the study. BMD measured as grams per square centimeter (g/cm2).|Measured at Baseline|Postmenopausal women with spinal osteoporosis.||g/cm2||Standard Deviation|Mean
701982|NCT00074802|Secondary|Quality of Life Inventory (QOLI)|The QOLI is a 16-item self-report measure of life satisfaction. Each item is rated for importance (0-2) and satisfaction (-3 to +3), and these ratings are multiplied, summed, and divided by the number of non-zero entries to yield an average item score, which can range from -6 to +6. We examined amount of change at from week 12 to week 28 as a secondary outcome. Change was calculated as Week 12 score minus Week 28 score, so a positive score equals greater positive change.|Change measured from Week 12 to Week 28|Data analysis was conducted via mixed-effects linear regression which allows use of data from patients with missing observations by using maximum likelihood estimation. The same holds true for all continuous outcome measures. However, mean change (and SDs) reported here is based on completed observations.||units on a scale||Standard Deviation|Mean
701983|NCT00074802|Secondary|Liebowitz Self-Report Disability Scale (LSRDS)|The LSRDS is an 11-item self-report measure of the degree to which one's emotional problems limit one's ability to function in a variety of domains. Items are rated on a 0-3 scale of severity, and 10 of the 11 items (choosing either school or work as one area and omitting the other) are summed to produce a total score, ranging from 0-30. Higher scores represent greater disability. We examined amount of change at from week 12 to week 28 as a secondary outcome. Change was calculated as Week 12 score minus Week 28 score, so a positive score equals greater positive change.|Change measured from Week 12 to Week 28|Data analysis was conducted via mixed-effects linear regression which allows use of data from patients with missing observations by using maximum likelihood estimation. The same holds true for all continuous outcome measures. However, mean change (and SDs) reported here is based on completed observations.||units on a scale||Standard Deviation|Mean
701984|NCT00074802|Secondary|Brief Fear of Negative Evaluation Scale (BFNE)|The BFNE is a 12-item self-report measure of concern about negative evaluation by others. Items are rated on a 1-5 scale, yielding scores ranging from 12-60, with higher scores indicating greater fear of negative evaluation. We examined amount of change at from week 12 to week 28 as a secondary outcome. Change was calculated as Week 12 score minus Week 28 score, so a positive score equals greater positive change.|Change measured from Week 12 to Week 28|Data analysis was conducted via mixed-effects linear regression which allows use of data from patients with missing observations by using maximum likelihood estimation. The same holds true for all continuous outcome measures. However, mean change (and SDs) reported here is based on completed observations.||units on a scale||Standard Deviation|Mean
701985|NCT00074802|Secondary|Social Phobia Scale (SPS)|The SPS is a 20-item self-report measure of anxiety experienced when being observed by others. Items are rated on a 0-4 scale, yielding a range of scores from 0-80, with higher scores representing greater anxiety. We examined amount of change at from week 12 to week 28 as a secondary outcome. Change was calculated as Week 12 score minus Week 28 score, so a positive score equals greater positive change.|Change measured from Week 12 to Week 28|Data analysis was conducted via mixed-effects linear regression which allows use of data from patients with missing observations by using maximum likelihood estimation. The same holds true for all continuous outcome measures. However, mean change (and SDs) reported here is based on completed observations.||units on a scale||Standard Deviation|Mean
701986|NCT00074802|Secondary|Social Interaction Anxiety Scale (SIAS)|The SIAS is a 20-item self-report measure of anxiety experienced while interacting in dyads or groups. Items are rated on a 0-4 scale, yielding a range of scores from 0-80, with higher scores representing greater anxiety. We examined amount of change at from week 12 to week 28 as a secondary outcome. Change was calculated as Week 12 score minus Week 28 score, so a positive score equals greater positive change.|Change measured from Week 12 to Week 28|Data analysis was conducted via mixed-effects linear regression which allows use of data from patients with missing observations by using maximum likelihood estimation. The same holds true for all continuous outcome measures. However, mean change (and SDs) reported here is based on completed observations.||units on a scale||Standard Deviation|Mean
701987|NCT00074802|Secondary|Clinical Global Impression Improvement Scale (CGI-I)|The CGI-I is a 7-point clinician-administered scale measuring improvement in symptoms over time. Lower numbers represent greater improvement. We examined responder status (i.e., percent of patients receiving an endpoint, Week 28, rating of 1 or 2) as well as remission status (i.e., percent of patients receiving an endpoint, Week 28, rating of 1) as secondary outcomes.|Responder and remitter status measured at Week 28|Responders (CGI-I=1 or 2). Remitters (CGI-I=1). Analyses based on Week 28 observations if available. if not, Week 20 or Week 12 observations were substituted. Fisher's Exact Test used for analyses.||Participants|||Count of Participants
701988|NCT00074802|Primary|Liebowitz Social Anxiety Scale (LSAS)|The LSAS is a 24-item clinician-administered measure, which provides 0-3 ratings for anxiety and avoidance of social and performance situations. Anxiety and avoidance ratings are summed across items, yielding a range of scores from 0-144, with higher scores representing greater severity of social anxiety symptoms. We examined amount of change from week 12 to week 28 as the primary outcome. Change was calculated as Week 12 score minus Week 28 score, so a positive score equals greater positive change.|Change measured from Week 12 to Week 28|Data analysis was conducted via mixed-effects linear regression which allows use of data from patients with missing observations by using maximum likelihood estimation. The same holds true for all continuous outcome measures. However, mean change (and SDs) reported here is based on completed observations.||units on a scale||Standard Deviation|Mean
701989|NCT00074815|Secondary|Pediatric Adverse Event Rating Scale (PAERS)||Measured at baseline; Weeks 4, 8, and 12; and Months 3 and 6 of follow-up||||||
701990|NCT00074815|Secondary|Child Depression Inventory||Measured at baseline; Weeks 4, 8, and 12; and Months 3 and 6 of follow-up||||||
701991|NCT00074815|Secondary|Child Obsessive -Compulsive Impact Scale (COIS)||Measured at baseline; Weeks 4, 8, and 12; and Months 3 and 6 of follow-up||||||
701992|NCT00074815|Primary|Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)|"OCD symptom severity was measured using the CY-BOCS, an interviewer-rated instrument that assess obsessions and compulsions separately on time consumed, distress, interference, degree of resistance, and control; it yields separate severity scores for obsessions and for compulsions (0 – 20), and a composite symptom severity score (0 to 40).
Consistent with signal detection analyses examining the optimal criterion for treatment response, a CY-BOCS reduction of 30% or more from baseline to week 12 was used as the criterion for RESPONSE and was the primary dichotomous outcome measure."|Measured at baseline and Week 12.|Intent to treat (all included)||Proportion of Participants with RESPONSE||95% Confidence Interval|Number
701993|NCT00074958|Secondary|Plasma GL-3|Plasma GL-3 values at Baseline, Week 24, and Week 48. Normal plasma GL-3 level is ≤ 7.03 µg/mL.|Baseline, Week 24 and Week 48|ITT population. 16 male patients had plasma GL-3 values at Baseline and Week 24, while 15 male patients had plasma GL-3 values at Week 48. 2 female patients had plasma GL-3 values at Baseline, Week 24 and Week 48.||µg/mL||Standard Deviation|Mean
701994|NCT00074958|Primary|Globotriaosylceramide (GL-3) Clearance in Capillary Endothelium in the Skin|Skin biopsies were taken at Baseline, Week 24 and Week 48 and analyzed for cellular GL-3 accumulation (inclusions) by light microscopy. Each biopsy was evaluated by pathologists for the total number of vessels with GL-3 accumulation on an inclusion severity score of 0 (none/trace), 1 (mild), 2 (moderate), and 3 (severe).|Baseline, Week 24 and Week 48|Intent to Treat (ITT) population – male patients only. 14 patients had skin biopsies performed at Baseline and Week 24 but only 5 patients had skin biopsies performed at Week 48.||patients|||Number
701995|NCT00074984|Secondary|Neuropathic Pain as Assessed by Question 12 of the Brief Pain Inventory (BPI) Questionnaire (Pain at Its Worst)|Neuropathic pain was assessed by Question 12 of the Brief Pain Inventory (BPI) Questionnaire on a scale of 0 (no pain) to 10 (pain as bad as you can imagine)|at 24 months|Intent-to-treat population||units on a scale||Standard Deviation|Mean
701996|NCT00074984|Secondary|Slope of Inverse Serum Creatinine Values Comparing Placebo vs Fabrazyme (Agalsidase Beta)Patients|Summary of slopes of inverse serum creatinine by baseline serum creatinine subgroups (> or <= 1.5 mg/dL) comparing Placebo vs Fabrazyme (agalsidase beta) patients.|up to 35 months|The Intent-to-treat population consisted of all 82 patients who were randomized, enrolled, and received at least one infusion of study medication.||dL/mg/year||Standard Deviation|Mean
701997|NCT00074984|Secondary|Slope of Estimated Glomerular Filtration Rate (eGFR) Comparing Placebo vs Fabrazyme (Agalsidase Beta) Patients|Summary of slopes of eGFR by baseline eGFR subgroups (>60 and <=60 mL/min/1.73m^2/year) comparing Placebo vs Fabrazyme (agalsidase beta) Patients.|up to 35 months|The Intent-to-treat population consisted of all 82 patients who were randomized, enrolled, and received at least one infusion of study medication||mL/min/1.73m^2/year||Standard Deviation|Mean
701998|NCT00074984|Secondary|Number of Participants Experiencing a Renal Event in Fabrazyme (Agalsidase Beta) Patients as Compared to Placebo Patients|Time to a clinically significant renal event (33% increase in serum creatinine, dialysis or transplant) in Fabrazyme (agalsidase beta) patients as compared to placebo patients.|up to 35 months|The Intent-to-treat population consisted of all 82 patients who were randomized, enrolled, and received at least one infusion of study medication.||participants|||Number
701999|NCT00074984|Primary|Number of Participants Experiencing a Clinically Significant Renal, Cardiac or Cerebrovascular Event and/or Death in Fabrazyme (Agalsidase Beta) Patients as Compared to Placebo Patients|The primary efficacy endpoint was the time to the first occurrence of a clinically significant renal (33% increase in serum creatinine, dialysis or transplant), cardiac (myocardial infarction, significant change in cardiac status, i.e., angina, congestive heart failure or symptomatic arrhythmia requiring medication or surgery) or cerebrovascular (stroke or transient ischemic attack) event and/or death (due to any cause) in Fabrazyme (agalsidase beta) patients as compared to placebo patients.|up to 35 months|The Intent-to-treat (ITT) population consists of all 82 patients who were randomized, enrolled, and received at least one infusion of study medication.||participants|||Number
702003|NCT00075088|Primary|Hospital Time to Treatment for Patients With Unstable Angina/Non-STEMI|Time from ED arrival to first drug was determined as recommended by American College of Cardiology/American Heart Association 2007 guidelines for management of patients with unstable angina/non-STEMI|Day 1|Patients with unstable angina/non-STEMI. Four patients with Do Not Resuscitate (DNR) orders were excluded from this time-to-treatment analysis||minutes||Standard Deviation|Mean
702004|NCT00075218|Secondary|Change From Baseline in EQ-5D Health State Profile Index|Change: median index score at observation minus median index score at baseline. EQ-5D is a generic instrument that describes health status in 5 dimensions (mobility, self-care, pain/discomfort, anxiety/depression, usual activities) with a weighted health Index based on general population values where where 0.0 = death and 1.0 = perfect health.|Day 1 & 28 of each cycle : duration of double-blind treatment phase|ITT Population. Number subjects with evaluable data: (n=sunitinib, placebo)||score on scale||Full Range|Median
702005|NCT00075218|Secondary|Change From Baseline Score in EuroQoL Visual Analog Scale (EQ-VAS)|Change: median score at observation minus median score at baseline. EQ-VAS score on the self-rated “thermometer,” indicating the patient's own assessment of their health status from 0 (worst) to 100 (best) imaginable health state.|Day 1 & 28 of each cycle : duration of double-blind treatment phase|ITT population. Number subjects with evaluable data: (n=sunitinib, placebo)||score on scale||Full Range|Median
702006|NCT00075218|Secondary|Subjects With Pain Relief Response Using McGill Pain Questionnaire-present Pain Intensity (MPQ-PPI)|MPQ-PPI: 0=no pain to 5= excruciating pain. Pain Relief Response= 1) Decrease by >= 1 points in MPQ-PPI score with either Decrease or No Change in total analgesic use >= 50% over baseline OR 2) No change in MPQ-PPI score with Decrease total analgesic use >= 50% over baseline.|Day 1 & 28 of each cycle : duration of double-blind treatment phase|Pain-Relief-Response population.||participants|||Number
702007|NCT00075218|Secondary|Time to Pain Progression Using McGill Pain Questionnaire-present Pain Intensity (MPQ-PPI)|25th Quartile: Time to Progression. Progression: a) No change (NC) in MPQ-PPI score (0=no pain to 5=excruciating pain) with increase total analgesic use >= 50% over baseline OR b) Increase score >= 1 point with either NC in total analgesic use or increase total analgesic use >= 50% over baseline. (50th Quartile not achieved.)|Day 1 & 28 of each cycle : duration of double-blind treatment phase|Pain-Relief-Response population. Subjects at 25th Quartile with pain progress during blinded phase.||weeks (25th Quartile)||95% Confidence Interval|Median
702008|NCT00075218|Primary|Time to Tumor Progression (TTP) as Assessed in the Double-blind Treatment Phase at End of Study|Time from randomization to first documentation of objective tumor progression based on the assessment of an independent, third-party imaging laboratory using RECIST (Response Evaluation Criteria in Solid Tumors).|Day 28 of each 6-week cycle : duration of double-blind treatment phase after Last Subject Last Visit (LSLV)|From the Intent to Treat (ITT) population, 91 subjects on sunitinib treatment were observed to have disease progression during blinded phase and were included in TTP analysis. 73 subjects on placebo were observed to have disease progression during blinded phase.||weeks||95% Confidence Interval|Median
702009|NCT00075218|Secondary|Duration of Performance Status Maintenance|Time from randomization until the last time the performance status was no worse than at baseline or to death due to cancer in the absence of previous documentation of performance status worsening.|Day 28 of each cycle : duration of double-blind treatment phase|ITT Population. Number of subjects at median observed to have status worsening or died before status worsening.||weeks||95% Confidence Interval|Median
702010|NCT00075218|Secondary|Time to Tumor Response (TTR)|Time from date of randomization to first documentation of objective tumor response that was subsequently confirmed. TTR was only calculated for the subgroup of subjects with a confirmed objective tumor response.|Day 28 of each cycle : duration of double-blind treatment phase|ITT population. Number of subjects analyzed = number of subjects with tumor response.||weeks||95% Confidence Interval|Median
702011|NCT00075218|Secondary|Confirmed Objective Response (CR or PR) in Subjects|Overall confirmed objective response = confirmed Complete Response (CR) OR confirmed Partial Response (PR) according to RECIST. Confirmed responses were those that persisted on repeat imaging study ≥ 4 weeks after initial documentation of response.|Day 28 of each cycle : duration of double-blind treatment phase|ITT population.||participants|||Number
702012|NCT00075218|Secondary|Best Overall Tumor Response During Double-blind Treatment Phase|Tumor response according to Response Evaluation Criteria in Solid Tumors (RECIST).|Day 28 of each cycle : duration of double-blind treatment phase|ITT population||participants|||Number
702013|NCT00075218|Secondary|Overall Survival Based on the Rank Preserving Structural Failure Time Method|time from date of randomization to date of death due to any cause (rank preserving structural failure time method).|clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug|ITT population||weeks||95% Confidence Interval|Median
702014|NCT00075218|Secondary|Overall Survival|Time from date of randomization to date of death due to any cause.|clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug|ITT population; Number subjects Dead = 176, 90 (sunitinib, placebo respectively). Subjects who were not known to be dead at the time the database was closed for analysis were censored on the date they were last known to be alive.||weeks||95% Confidence Interval|Median
702015|NCT00075218|Secondary|Overall Survival Status of Subjects|Number of subjects alive at end of study.|clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug|ITT population.||participants|||Number
702016|NCT00075218|Secondary|Progression Free Survival (PFS)|Time from randomization to first documentation of objective tumor progression or to death due to any cause (on treatment or within 28 days of last dose).|Day 28 of each cycle : duration of double-blind treatment phase|ITT population||weeks||95% Confidence Interval|Median
702017|NCT00075218|Primary|Time to Tumor Progression (TTP) as Assessed by Imaging Studies at End of Double-blind Treatment Phase|Time from randomization to first documentation of objective tumor progression based on the assessment of an independent, third-party imaging laboratory using RECIST (Response Evaluation Criteria in Solid Tumors).|Day 28 of each 6-week cycle : duration of double-blind treatment phase|From the Intent to Treat (ITT) population, 82 subjects on sunitinib treatment were observed to have disease progression during blinded phase and were included in TTP analysis. 67 subjects on placebo were observed to have disease progression during blinded phase.||weeks||95% Confidence Interval|Median
706186|NCT00105482|Primary|Point Prevalence Smoking Abstinence at 26 Weeks.|The number of people that were abstinent from cigarette smoking at 26 weeks.|26 weeks|All patients who were randomized comprised the primary ITT population.||participants|||Number
702018|NCT00075270|Secondary|Number of Participants With the Indicated Adverse Events (AEs) With a Maximum Toxicity Grade of 3 or 4|The severity of adverse events was graded per the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 3. Grades 1 through 5 have unique clinical descriptions of severity for each AE based on the following general guideline: Grade 1, Mild AE; Grade 2, Moderate AE; Grade 3, Severe AE; Grade 4, Life-threatening or disabling AE; Grade 5, death related to AE.|Baseline (Day 1) until 30 days after the last dose of randomized therapy (average of 26 weeks)|Safety Population: all randomized participants who received at least one dose of investigational product (based on the actual treatment received if this differed from that to which the participant was randomized). Two participants randomized to the placebo group actually received lapatinib.||participants|||Number
702019|NCT00075270|Secondary|Serum ErbB2 Concentration|The Quest Laboratory collected blood samples for quantitative determination of serum ErbB2. The results of serum monitoring were used to compare tumor response rates following randomized therapy.|Screening (Day-1) and Withdrawal (up to Study Week 129)|ITT Population. Only participants contributing data at the indicated time points were analyzed. Only observed data were collected, and score analyses were conducted using the LOCF method.||ng/mL||Standard Deviation|Mean
702020|NCT00075270|Secondary|Serum ErbB1 Concentration|The Quest Laboratory collected blood samples for quantitative determination of serum ErbB1. The results of serum monitoring were used to compare tumor response rates following randomized therapy.|Screening (Day-1) and Withdrawal (up to Study Week 129)|ITT Population. Only participants contributing data at the indicated time points were analyzed. Only observed data were collected, and score analyses were conducted using the LOCF method.||Nanograms per milliliter (ng/mL)||Standard Deviation|Mean
702021|NCT00075270|Secondary|Number of Participants With the Indicated ErbB2 Fluorescence in Situ Hybridization (FISH) Results|"The Press Laboratory tested participants who were 2+ (weak to moderate complete staining) or 3+ (strong complete staining) for ErbB2 overexpression by IHC for ErbB2 gene amplification using the FISH assay. The results of the FISH assay can be ErbB2 gene amplification (increased number of copies of the ErbB2 gene) or non-amplification (not many copies of the ErbB2 gene). A status of Assay not done was assigned to those participants with no available samples and to those with inconclusive results (e.g., due to hybridization or staining problems)."|Baseline|ITT Population||participants|||Number
702022|NCT00075270|Secondary|Number of Participants With the Indicated Immunohistochemistry (IHC) Results at Screening|"The Press Laboratory tested tumor tissue samples (taken at Screening, prior to randomization to study treatment) to determine intra-tumoral expression levels of ErbB1, ErbB2, and other analytes associated with these pathways by IHC, the process of detecting antigens (e.g., proteins) in cells of a tissue section. The IHC assessment is expressed as: 0, no staining (no cancer cells); 1+, faint staining; 2+, weak to moderate complete staining; 3+, strong complete staining (many cancer cells). A status of Assay not done was assigned to participants with no available samples and to those with inconclusive results. If strong staining is observed, breast cancer that has high levels of HER2 expression (overexpression) is indicated. If moderate/weak staining is observed (IHC=2+), breast cancer that has low/moderate expression levels is indicated. When no staining is observed (IHC=0), breast cancer HER2 expression may be below the level of detection of the assay."|Screening (Day -1)|ITT Population||participants|||Number
702023|NCT00075270|Secondary|ErbB2 Ratio|The Press Laboratory collected tumor tissues of participants for biomarker testing. All samples were analyzed by the Press Laboratory. The ratio of ErbB2 gene signals to chromosome 17 signals, which indicates the progression of breast cancer, was calculated. Low levels of amplification (few copies) may have a ratio of 2-5, whereas high levels of amplification may have a ratio >10.|Baseline|ITT Population. Only participants contributing data at the indicated time points were analyzed. Only observed data were collected, and score analyses were conducted using the LOCF method.||ratio of signals||Standard Deviation|Mean
702024|NCT00075270|Secondary|Number of Participants With the Indicated ErbB2 Status at Baseline|The Press Laboratory collected tumor tissues of participants for ErbB2 testing. ErbB2 testing is done to detect breast cancer and predict its likely outcome. All samples were analyzed by the Press Laboratory. Participants were categorized as ErbB2 positive (overexpression of the ErbB2 gene), ErbB2 negative, and assay not done (which included participants with no available samples and those with inconclusive results). ErbB2 status is determined by immunohistochemistry (ICH) assay and fluorescence in situ hybridization (FISH) testing. Negative ErbB2 status is defined as 0 or 1+ by IHC, or as 2+ by IHC and FISH.|Baseline|ITT Population||participants|||Number
702025|NCT00075270|Secondary|Change From Baseline in Trial Outcome Index (TOI) Questionnaire Scores|The TOI questionnaire was designed to measure multidimensional QOL in participants with cancer and includes subscales for physical, functional well-being, and additional cancer concerns. The physical and functional well-being subscale scores range from 0 to 28, based on 7 questions (each question scored from 0 [not at all] to 4 [very much]); the breast cancer unweighted subscale scores range from 0 to 36, based on 9 questions. The total TOI score (ranging from 0 [better QOL] to 92 [worse QOL]) is the sum of the TOI subscale scores.|Baseline (Day 1); Weeks 9, 21, 33, and 45; Withdrawal|ITT Population. Only participants contributing data at the indicated time points were analyzed. Only observed data were collected, and score analyses were conducted using the LOCF method.||Scores on a scale||Standard Deviation|Mean
702026|NCT00075270|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) Questionnaire Scores|The FACT-G questionnaire was designed to measure multidimensional QOL in participants with cancer and includes subscales for physical, social/family, emotional, and functional well-being. The physical, social/family, and functional well-being subscale scores range from 0 to 28, based on responses to 7 questions (each question scored from 0 [not at all] to 4 [very much]); the emotional well-being subscale score ranges from 0 to 24, based on responses to 6 questions. The FACT-G Total Score (ranging from 0 [better QOL] to 108 [worse QOL]) is the sum of the subscale scores.|Baseline (Day 1); Weeks 9, 21, 33, and 45; Withdrawal|ITT Population. Only participants contributing data at the indicated time points were analyzed. Only observed data were collected, and score analyses were conducted using the LOCF method.||Scores on a scale||Standard Deviation|Mean
702059|NCT00075504|Primary|Response Rate According to RECIST Criteria|Tumor response was assessed every eight weeks by CT scan using RECIST (Response Evaluation Criteria in Solid Tumors) criteria. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disapperance of all target lesions; Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions; Overall response (OR) = CR+PR.|Up to 2 years|||participants|||Number
702027|NCT00075270|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) Questionnaire Scores|The FACT-B questionnaire was designed to measure multidimensional quality of life (QOL) in participants with breast cancer. The physical and functional well-being subscale scores range from 0 to 28, based on 7 questions (each scored from 0 [not at all] to 4 [very much] for all subscales); the emotional and social/family well-being (1 question optional) subscale scores range from 0 to 24 (based on 6 questions), and the additional concerns subscale score ranges from 0 to 40, based on 10 questions. The FACT-B Total Score (0 [better QOL] to 144 [worse QOL]) is the sum of the subscale scores.|Baseline (Day 1); Weeks 9, 21, 33, and 45; Withdrawal|ITT Population. Only participants contributing data at the indicated time points were analyzed. Only observed data were collected, and score analyses were conducted using the last observation carried forward (LOCF) method: the last available on-therapy observation for a participant was used to estimate missing data points.||Scores on a scale||Standard Deviation|Mean
702028|NCT00075270|Secondary|Overall Survival|Overall survival is defined as the time from randomization until death due to any cause.|Randomization until the date of death due to any cause (average of 24 months)|ITT population. Overall survival was assessed in participants who died as well as in those who were censored and completed follow-up and those who were censored but are still being followed. For censored participants (those still alive), the date of the last contact was used.||months||95% Confidence Interval|Median
702029|NCT00075270|Secondary|Number of Participants Who Progressed or Died at or Prior to 6 Months, as a Measure of Six Months Progression-free Survival (PFS)|PFS is defined as the interval between the date of randomization and the earliest date of disease progression or death due to any cause, if sooner. Six months PFS is defined as PFS at six months from the time of randomization. Raw data for 6 months PFS are not available; thus, data are presented as the number of participants who progressed or died at or prior to 6 months. For TLs, progressive disease is defined asat least a 20% increase in the sum of the LD of TLs or the appearance of 1 or more new lesions. For NTLs, progressive disease is defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. PFS was assessed in participants who died or progressed, as well as in those who were censored and completed follow-up and those who were censored but are still being followed. For censored participants (those without a documented date of disease progression/death due to breast cancer), the date of the last radiographic assessment was used.|Randomization until the date of disease progression or death (average of 26 weeks)|ITT Population||participants|||Number
702030|NCT00075270|Secondary|Progression-Free Survival (PFS)|PFS is defined as the interval between the date of randomization and the earliest date of progression disease (PD) or death due to any cause, if sooner. For TLs, progressive disease is defined as at least a 20% increase in the sum of the LD of TLs or the appearance of 1 or more new lesions. For NTLs, progressive disease is defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. par., participants.|Randomization until the date of disease progression or death (average of 26 weeks)|ITT Population. PFS was assessed in par. who died or progressed, as well as in those who were censored and completed follow-up and those who were censored but are still being followed. For censored par. (those without a documented date of disease progression/death due to any cause), the date of the last radiographic assessment was used.||weeks||95% Confidence Interval|Median
702031|NCT00075270|Secondary|Duration of Response (DOR)|The investigator evaluated the DOR for the subset of participants who showed a CR (disappearance of all TLs and NTLs) or PR (TLs: a >=30% decrease in the sum of the LD of TLs, taking as a reference the Baseline sum LD; NTLs: persistence of >=1 lesion). DOR is defined as the time from the first documented evidence of PR or CR until the first documented sign of PD (TL: a >=20% increase in the sum of the LD of TLs or the appearance of >=1 new lesion; NTL: the appearance of >=1 new lesion and/or unequivocal progression of existing NTLs) or death due to breast cancer, if sooner.|From the time of the first documented complete or partial response until the first documented evidence of progression or death (average of 26 weeks)|ITT Population. Only participants who had a CR or PR were evaluated.||weeks||Inter-Quartile Range|Median
702032|NCT00075270|Secondary|Number of Participants With a Response of CR or PR by the Indicated Study Week|Time to response (TTR) is defined as the time from randomization until the first documented evidence of CR (disappearance of all TLs and NTLs) or PR (for TLs: a >=30% decrease in the sum of the LD of TLs, taking as a reference the Baseline sum LD; for NTLs: the persistence of >=1 lesion) (whichever status was recorded first). TTR data are displayed as the number of participants achieving a CR or PR by the indicated week. The investigator evaluated the TTR, and the analysis was based on responses confirmed at a repeat assessment, with the TTR taken as the first time the response was observed.|Weeks 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, and 72|ITT Population||participants|||Number
702033|NCT00075270|Secondary|Percentage of Participants With Clinical Benefit (CB) as Assessed by the Investigator|Percentage of participants. with CB is defined as the percentage of participants with evidence of CR (disappearance of all TLs and NTLs), PR (TLs: a >=30% decrease in the sum of the LD, taking as a reference the Baseline sum LD; NTLs: persistence of >=1 lesion), or stable disease (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD) for >=6 months based on RECIST criteria. PD for TL: a >=20% increase in the sum of the LD of TLs or the appearance of >=1 new lesion. PD for NTLs: the appearance of >=1 new lesion and/or unequivocal progression of existing NTLs.|Randomization until the date of disease progression or death (average of 26 weeks)|ITT Population||Percentage of participants|||Number
702034|NCT00075270|Secondary|Number of Participants With Tumor Response as Evaluated by the Independent Review Committee|The percentage of participants with tumor response is defined as those participants with measurable disease who achieved either a complete response (CR) or partial response (PR). The RECIST criteria was used to evaluate the measurability of tumor lesions, to determine target lesion (TLs) and non-target lesion (NTLs). CR (TLs and NTLs): the disappearance of all TLs and NTLs; PR (for TLs): at least a 30% decrease in the sum of the largest diameter (LD) of TLs, taking as a reference the Baseline sum LD; PR (for NTLs): persistence of one or more lesions.|Randomization until the date of disease progression or death (average of 26 weeks)|ITT Population||participants|||Number
702060|NCT00075582|Secondary|Rate of Local Failure for Patients With Clinical Group III Disease When the Radiotherapy Dose is Reduced After Second-look Surgical Resection.|The local failure rate will be estimated using cumulative incidence curves.|Up to 20 weeks||||||
706187|NCT00105482|Primary|Weight Gain at 26 Weeks.|Weight change from baseline measured at 26 weeks.|26 weeks|All patients who were randomized comprised the primary ITT population.||pounds||Standard Deviation|Mean
702035|NCT00075270|Secondary|Number of Participants With Tumor Response as Evaluated by the Investigator|The percentage of participants with tumor response is defined as those participants with measurable disease who achieved either a complete response (CR) or partial response (PR). The Response Evaluation Criteria in Solid Tumors (RECIST) was used to evaluate the measurability of tumor lesions, to determine target lesion (TLs) and non-target lesion (NTLs). CR (TLs and NTLs): the disappearance of all TLs and NTLs; PR (for TLs): at least a 30% decrease in the sum of the largest diameter (LD) of TLs, taking as a reference the Baseline sum LD; PR (for NTLs): persistence of one or more lesions.|Randomization until the date of disease progression or death (average of 26 weeks)|ITT Population||participants|||Number
702036|NCT00075270|Primary|Time to Progression as Evaluated by the Independent Review Committee (IRC)|Time to progression is defined as the interval between the date of randomization and the earliest date of progression of disease (PD) or death due to breast cancer. The IRC assessed PD based on radiological PD (imaging data) and clinical symptomatic progress (Response Evaluation Criteria in Solid Tumors [RECIST] Criteria: target lesion (TL), at least a 20% increase in the sum of largest diameter (LD) of TLs or the appearance of one or more new lesions; non-TL (NTL), the appearance of one or more new lesions and/or unequivocal progression of existing NTLs). TTP was assessed in participants who died due to breast cancer or progressed, as assessed by the independent reviewer, as well as in those who were censored and completed follow-up and those who were censored but are still being followed. For censored participants (those without a documented date of disease progression/death due to breast cancer), the date of the last radiographic assessment was used.|Randomization until the date of disease progression or death (average of 26 weeks)|ITT Population||weeks||Inter-Quartile Range|Median
702037|NCT00075270|Primary|Time to Progression as Evaluated by the Investigator|Time to progression (TTP) is defined as the interval between the date of randomization and the earliest date of progression of disease (PD) or death due to breast cancer. The investigator assessed PD based on radiological PD (imaging data) and clinical symptomatic progress (Response Evaluation Criteria in Solid Tumors [RECIST] Criteria: target lesion (TL), at least a 20% increase in the sum of largest diameter (LD) of TLs or the appearance of one or more new lesions; non-TL (NTL), the appearance of one or more new lesions and/or unequivocal progression of existing NTLs). TTP was assessed in participants who died due to breast cancer or progressed, as assessed by the investigator, as well as in those who were censored and completed follow-up and those who were censored but are still being followed. For censored participants (those without a documented date of disease progression/death due to breast cancer), the date of the last radiographic assessment was used.|Randomization until the date of disease progression or death (average of 26 weeks)|Intent-to-Treat (ITT) Population: all randomized participants who had received at least one dose of randomized therapy (lapatinib or placebo)||weeks||Inter-Quartile Range|Median
702038|NCT00075400|Secondary|p-AKT2 Expression Levels in Archived, Formalin-fixed, Paraffin-embedded Primary Tumor Tissue|Potential associations with clinical or PFS response will be assessed.|Baseline||||||
702039|NCT00075400|Secondary|AKT2 Expression Levels in Archived, Formalin-fixed, Paraffin-embedded Primary Tumor Tissue by IHC|Potential associations with clinical or PFS response will be assessed.|Baseline||||||
702040|NCT00075400|Secondary|PDGFR Expression Levels in Archived, Formalin-fixed, Paraffin-embedded Primary Tumor Tissue by IHC|Potential associations with clinical or PFS response will be assessed.|Baseline||||||
702041|NCT00075400|Secondary|c-KIT Expression Levels in Archived, Formalin-fixed, Paraffin-embedded Primary Tumor Tissue by Immunohistochemistry (IHC)|Potential associations with clinical or PFS response will be assessed.|Baseline||||||
702042|NCT00075400|Secondary|Initial Histologic Grade|Assessed as a prognostic factor.|Baseline||||||
702043|NCT00075400|Secondary|Initial Performance Status|Assessed as a prognostic factor.|Baseline||||||
702044|NCT00075400|Secondary|Duration of PFS||Up to 5 years||||||
702045|NCT00075400|Secondary|Overall Survival|The observed length of life from entry into the study to death or the date of last contact|From study entry to death or last contact, up to 5 years.|Eligible and treated patients||months||95% Confidence Interval|Median
702046|NCT00075400|Secondary|Tumor Response|Complete and Partial Tumor Response by RECIST 1.0|For those patients whose disease can be evaluated by physical examination, response was assessed prior to each 28-day cycle. CT scan or MRI if used to follow measurable disease every other cycle for the first 6 months; every 6 months thereafter.|Eligible and treated patients||percentage of participants||90% Confidence Interval|Number
702047|NCT00075400|Primary|Incidence of Adverse Effects as Assessed by CTCAE v 3.0|The frequency and severity of all toxicities are tabulated from submitted case report forms and summarized for review.|Up to 5 years||||||
702048|NCT00075400|Primary|Progression-free Survival (PFS) > 6 Months|Whether or not the patient survived progression-free for at least 6 months.|For those patients whose disease can be evaluated by physical examination, progression was assessed prior to each 28-day cycle. CT scan or MRI if used to follow measurable disease every other cycle for the first 6 months; every 6 months thereafter.|Eligible and treated patients.||percentage of participants||90% Confidence Interval|Number
702049|NCT00075478|Secondary|Progression-free Survival|Percentage of patients with progression-free survival, estimated by cumulative incidence methods|3 years after transplant|||percentage of participants|||Number
702050|NCT00075478|Secondary|Incidence of Graft Rejection|Donor CD3 chimerism less than 5%|1 year after transplant|||participants|||Number
702051|NCT00075478|Secondary|Incidence of Chronic Extensive GVHD|Percentage patients with chronic extensive GVHD, estimated by cumulative incidence methods|3 years after transplant|||percentage of participants|||Number
702052|NCT00075478|Secondary|Incidence of Grades II-IV Acute GVHD|Percentage patients with grades II-IV GHVD, estimated by cumulative incidence methods|120 days after transplant|||percentage of participants|||Number
702053|NCT00075478|Secondary|Incidence of Relapse-related Mortality|Percentage of death following relapse/progression, estimated by cumulative incidence methods|3 years after transplant|||percentage of participants|||Number
702054|NCT00075478|Secondary|Incidence of Relapse/Progression|Percentage of relapse estimated by cumulative incidence methods|3 years after transplant|||percentage of participants|||Number
702055|NCT00075478|Secondary|Incidence of Non-relapse Mortality|Percentage of NRM as estimated by cumulative incidence methods with competing risks|3 years after transplant|||percentage of participants|||Number
702056|NCT00075478|Primary|Overall Survival|Percentage of patients surviving as estimated by Kaplan-Meier.|3 years after transplant|||percentage of participants|||Number
702061|NCT00075582|Secondary|Rate of Second-look Surgery and the Proportion of Patients Who Are Tumor-free or With Microscopic Tumor Only Following Second-look Surgeries|The decision to perform second-look surgery should be based on the physical examination and imaging studies at Week 12 and should only be considered if a reasonable functional and cosmetic result is anticipated.|At 13 weeks||||||
702062|NCT00075582|Secondary|Rate of Local Failure for Patients Who Receive Reduced Doses of Radiation Therapy|The local failure rate will be estimated using cumulative incidence curves.|Up to 10 years||||||
702063|NCT00075582|Primary|Estimated Percentage of Patients With Low-risk Rhabdomyosarcoma Treated With Regimen 2 Therapy Failure Free at 5 Years (95% Confidence Interval).|Failure free survival: Time to disease recurrence or death as a first event. An analysis plan based on the method of Woolson (1981) will be used to monitor outcome for these patients.|5 years from study enrollment|All eligible patients among this subset of regimen 2 patients were included in this outcome measure to regimen 2 patients (there were 16 patients determined ineligible). Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome measures.||Estimated percentage of participants||95% Confidence Interval|Number
702064|NCT00075582|Primary|Estimated Percentage of Patients With Stage 1, Clinical Group IIB or C (Node Positive) or Stage 2 Group I or Stage 2 Group II Disease Treated With Regimen 1 Failure-free at 5 Years|Failure-free survival: Time to disease recurrence or death as a first event. An analysis plan based on the method of Woolson (1981) will be used to monitor outcome for these patients.|5 years from study enrollment|All eligible patients among this subset of regimen 1 patients were included in this outcome measure restricted to regimen 1 patients (there were 36 patients determined ineligible). Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome measures.||Estimated percentage of participants||95% Confidence Interval|Number
702065|NCT00075582|Primary|Estimated Percentage of Patients Failure Free at 5 Years (95% Confidence Interval)|Failure-free survival: Time to disease recurrence or death as a first event. An analysis plan based on the method of Woolson (1981) will be used to monitor outcome for these patients.|5 years from study enrollment|Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.||Estimated percentage of participants||95% Confidence Interval|Number
702066|NCT00075608|Primary|Evaluate Immune Reconstitution|Evaluate immune reconstitution based on time to engraftment|3 months after treatment and annually|No data were collected or analyzed due to study termination|||||
702067|NCT00075608|Primary|Response and Durability of Response|Response and durability of response will be based on hematologic Complete Response or Partial Response and date of relapse or death|3 months after treatment and annually|No data were collected or analyzed due to study termination|||||
702068|NCT00075608|Primary|Feasibility and Tolerability|Feasibility and tolerability will be evaluated based on participants completing second transplant with tolerable adverse events|3 months after treatment and annually|No data were collected or analyzed due to study termination|||||
702069|NCT00075725|Secondary|Correlation of Minimal Residual Disease (MRD) Negative With Event Free Survival (EFS).|Bone marrow MRD status is defined as negative with < 0.1 detectable leukemia cells.|5 years|Group “Prednisone and High Dose MTX (non-random)” who either had EFS/OS events occur before 5 years or did not have minimum 5 years of follow-up.||percentage of participants||95% Confidence Interval|Number
702070|NCT00075725|Secondary|Correlation of Minimal Residual Disease (MRD) Positive With Event Free Survival (EFS)|Bone marrow MRD status is defined as positive with >= 0.1 detectable leukemia cells.|5 years|"Groups Prednisone Capizzi MTX (Down's Syndrome), Dexamethasone, Capizzi MTX (non-random) & Prednisone and High Dose MTX (non-random) are not included in this OM as no patients survived the 5 year window for analysis. Cohort of MRD Positive patients who either had EFS/OS events occur before 5 years or did not have minimum 5 years of follow-up."||percentage of participants||95% Confidence Interval|Number
702071|NCT00075725|Secondary|Correlation of Early Marrow Response Status With MRD Negative.|Bone marrow status is defined as: M1: < 5% lymphoblasts; M2: 5-25% lymphoblasts; M3: > 25% lymphoblasts. Bone marrow MRD status is defined as positive with >= 0.1 detectable leukemia cells, and negative with < 0.1 detectable leukemia cells.|Day 29|||participants|||Number
702072|NCT00075725|Secondary|Correlation of Early Marrow Response Status With MRD Positive.|Bone marrow status is defined as: M1: < 5% lymphoblasts; M2: 5-25% lymphoblasts; M3: > 25% lymphoblasts. Bone marrow MRD status is defined as positive with >= 0.1 detectable leukemia cells, and negative with < 0.1 detectable leukemia cells.|Day 29|||participants|||Number
702073|NCT00075725|Secondary|Correlation of Minimal Residual Disease (MRD) Negative With Overall Survival (OS).|Bone marrow MRD status is defined as negative with < .01 detectable leukemia cells.|5 years|"Patients on Arm/Group Prednisone and High Dose Methotrexate (non randomly assigned) are not included in the OM as there were no survivors for the 5 year duration. Cohort of MRD Negative patients some of whom have had EFS/OS events after 5 years or have minimum 5 years of follow-up."||percentage of participants||95% Confidence Interval|Number
702074|NCT00075725|Secondary|Correlation of Minimal Residual Disease (MRD) Positive With Overall Survival (OS)|Bone marrow MRD status is defined as positive with >= 0.1 detectable leukemia cells, and negative with < 0.1 detectable leukemia cells.|5 Years|"Groups Prednisone Capizzi MTX (Down's Syndrome), Dexamethasone, Capizzi MTX (non-random) & Prednisone and High Dose MTX (non-random) are not included in this OM as no patients survived the 5 year window for analysis. Cohort of MRD Positive patients who either had EFS/OS events occur before 5 years or did not have minimum 5 years of follow-up."||percentage of participants||95% Confidence Interval|Number
702075|NCT00075725|Primary|Comparison of the Increase in Cure Rate of High Risk ALL Without Causing More Serious Side Effects Between Interventions|Event Free Probability.|5 years|Group “Prednisone and High Dose MTX (non-random)” who either had EFS events occur before 5 years or did not have minimum 5 years of follow-up.||percentage of participants||95% Confidence Interval|Number
702076|NCT00075764|Secondary|Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs|Adverse Events (AEs) are reported by CTCAE version 3.0 terminology. For each patient, worst grade of each event type is reported. Grade3 (Severe), Grade4 (Life-threatening), Grade 5 (Fatal)|Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.|Eligible patients who had received the protocol treatments were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.||Participants|||Number
702077|NCT00075764|Secondary|Overall Survival|From date of randomization to date of death due to any cause. Patients last known to be alive are censored at last date of contact.|Every 4 weeks while on treatment. Then every 3 months until progression, then six months for two years then annually until four years or until death, which ever occurs first.|||months||95% Confidence Interval|Median
702078|NCT00075764|Secondary|Clinical Benefit (CR, PR, Confirmed or Unconfirmed, or Stable Disease >= 24 Weeks).|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable, Does not qualify for CR, PR, Progression or Symptomatic Deterioration. Clinical Benefit = CR + PR + Stable >= 24 weeks|Every 4 weeks while on treatment. Then every 3 months until progression, then six months for two years then annually until four years or until death, which ever occurs first.|||percentage of participants|||Number
702079|NCT00075764|Primary|Time to Tumor Progression|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target measurable lesions over the smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline. Unequivocal progression of non-measurable disease in the opinion of the treating physician. Appearance of any new lesion/site. Death due to disease without prior documentation of progression and without symptomatic deterioration. From date of randomization to time of first documentation of progression, symptomatic deterioration or death due to any cause. Patients last known to be alive and progression free are considered at last date of contact.|Every 4 weeks while on treatment. Then every 3 months until progression, then six months for two years then annually until four years or until death, which ever occurs first.|||months||95% Confidence Interval|Median
702080|NCT00075803|Secondary|Freedom From Possible, Presumptive, Probable, or Proven Invasive Fungal Infection, Death, or Withdrawal of Study Drug Due to Toxicity, Intolerance, or an Empirical Trial of Amphotericin B or Caspofungin Greater Than 14 Consecutive Days||1 year|||participants|||Number
702081|NCT00075803|Secondary|Failure to Engraft||day 42|||participants|||Number
702082|NCT00075803|Secondary|Time to Platelet Engraftment||180 days||||||
702083|NCT00075803|Secondary|Time to Neutrophil Engraftment||28 days||||||
702084|NCT00075803|Secondary|Utility of Galactomannan Assay in Diagnosis of Aspergillus and Response to Therapy|Although there were 82 Galactomannan (GM) positives, 4 were excluded due to piperacillin/tazobactam administration, without other documentation of IFI, and were deemed false positives.|1 year|||participants|||Number
702085|NCT00075803|Secondary|Time to and Severity of Acute and Chronic Graft vs Host Disease (GVHD)||100 and 365 days|||participants|||Number
702086|NCT00075803|Secondary|Duration of Use of Amphotericin B or Caspofungin||180 days|||days||Inter-Quartile Range|Mean
702087|NCT00075803|Secondary|Frequency of Use of Amphotericin B or Caspofungin||1 year|||percentage of patients||95% Confidence Interval|Number
702088|NCT00075803|Secondary|Relapse Free Survival||100, 180, and 365 days|||percentage of patients||95% Confidence Interval|Number
702089|NCT00075803|Secondary|Overall Survival||100, 180, and 365 days|||percentage of patients||95% Confidence Interval|Number
702090|NCT00075803|Secondary|Percentage of Patients With Invasive Fungal Infection at 100, 180, and 365 Days||100, 180, and 365 days|||percentage of patients||95% Confidence Interval|Number
702091|NCT00075803|Secondary|Frequency of Invasive Fungal Infections (IFI)|Incidence of proven, probably, or presumptive IFI|1 year|||percentage of patients||95% Confidence Interval|Number
702092|NCT00075803|Primary|Fungal-free Survival (Percentage of Participants Alive and Free From Proven, Probable, or Presumptive Invasive Fungal Infection) at 180 Days Post-transplant||180 days|All randomized patients were included in the analysis||percentage of patients||95% Confidence Interval|Number
702093|NCT00075816|Secondary|Patient Quality of Life||Measured at baseline, 6 months, and 1, 2, and 5 years|No data collected|||||
702094|NCT00075816|Secondary|Donor Quality of Life||Measured at 1, 6, and 12 months|No data collected|||||
702095|NCT00075816|Secondary|Donor Recovery to Baseline Toxicity Scores||Measured at 1, 6, and 12 months|No data collected|||||
702096|NCT00075816|Secondary|Donor Recovery of Baseline Complete Blood Count (CBC) and White Blood Cell Count (WBC) Differential||Measured at 1, 6, and 12 months|No data collected|||||
702097|NCT00075816|Secondary|Immune Reconstitution||Measured at 100 days, 6 months, and 1 and 2 years|No data collected|||||
702098|NCT00075816|Secondary|Current Immunosuppressive (IS) Free Survival|This outcome measure takes into account subsequent immunosuppressive therapy that may occur following discontinuation of initial immunosuppressive therapy.|Measured at 2 years|No data collected.|||||
702099|NCT00075816|Secondary|Acute GVHD Grade III-IV||100 days, 180 days|||percentage of patients||95% Confidence Interval|Number
702100|NCT00075816|Secondary|Acute GVHD Grade II-IV||100 days, 180 days|||percentage of patients||95% Confidence Interval|Number
702101|NCT00075816|Secondary|Grades III-V Unexpected Adverse Events||Measured by 2 years|||participants|||Number
702102|NCT00075816|Secondary|Infections|Number of infection reports per patient.|Measured at 1 and 2 years|Analysis restricted to patients who received the transplant.||participants|||Number
702103|NCT00075816|Secondary|Relapse|Analysis restricted to patients who received the transplant.|Measured at 2 years|||percentage of patients||95% Confidence Interval|Number
702104|NCT00075816|Secondary|Chronic GVHD||Measured at 2 years|||percentage of participants||95% Confidence Interval|Number
702105|NCT00075816|Secondary|Extensive Chronic Graft-versus-host Disease (GVHD)||Measured at 730 days|||percentage of patients||95% Confidence Interval|Number
702106|NCT00075816|Secondary|Graft Failure||Measured at 28 and 100 days|||percentage of patients||95% Confidence Interval|Number
702107|NCT00075816|Secondary|Platelet Engraftment||Measured at Day 180|||percentage of patients||95% Confidence Interval|Number
702108|NCT00075816|Secondary|Neutrophil Engraftment||Measured at Day 28|||percentage of patients|||Number
702109|NCT00075816|Primary|Two-year Overall Survival|Overall survival rate at 2 years according to an intention-to-treat analysis.|Measured at 2 years|||percentage of patients||95% Confidence Interval|Number
702148|NCT00068419|Secondary|Tumor Response Rate According to Response Evaluation Criteria in Solid Tumors (RECIST)||Up to 5 years||||||
702110|NCT00075829|Secondary|Incidences of Chronic GVHD|Incidence and severity of chronic GVHD will be scored according to the BMT clinical trials network Manual of Procedures.|Years 1 and 2|GVHD was only assessed on the Auto-Allo arm for standard risk patients that completed second transplant||percentage of patients||95% Confidence Interval|Number
702111|NCT00075829|Secondary|Incidences of Graft Versus Host Disease (GVHD)|Incidence and severity of GVHD will be scored according to the BMT clinical trials network Manual of Procedures.|Day 100|GVHD was only assessed on the Auto-Allo arm for standard risk patients that completed second transplant||percentage of patients||95% Confidence Interval|Number
702112|NCT00075829|Secondary|Interval From First to Second Transplantation|Upon recovery from the first autograft, but at least 60 days (preferably between 60-120 days) after the first autograft, patients will receive a second transplant according to treatment assignments.|Year 1|Patients that completed second transplant||days||Full Range|Median
702113|NCT00075829|Secondary|Cumulative Incidence of Treatment Related Mortality (TRM)|TRM is defined as death occurring in a patient from causes other than relapse or progression.|Year 3|Patients that completed second transplant||percentage of participants||95% Confidence Interval|Number
702114|NCT00075829|Secondary|Cumulative Incidence of Progression/Relapse|Patients are considered experiencing an event when they progress. Deaths without progression are considered as a competing risk. Patients initiating non-protocol anti-myeloma therapy are considered to have progressed on this protocol.|Year 3|Patients that completed second transplant||percentage of patients||95% Confidence Interval|Number
702115|NCT00075829|Secondary|Overall Survival (OS) for High Risk|The event is death from any cause, patients alive at the time of last observation are considered censored.|Year 3|Patients that completed second transplant||percentage of participants||95% Confidence Interval|Number
702116|NCT00075829|Secondary|Overall Survival (OS) for Standard Risk|The event is death from any cause, patients alive at the time of last observation are considered censored.|Years 1, 2, and 3|Patients that completed second transplant||percentage of patients||95% Confidence Interval|Number
702117|NCT00075829|Primary|Progression-Free Survival (PFS)|Patients are considered a failure for this endpoint if they die or if they progress or relapse.|Year 3|Patients that completed second transplant||percentage of patients||95% Confidence Interval|Number
702118|NCT00067990|Secondary|Number of Participants With Cortical Interstitial Volume Expansion or Any ESRD|Number of subjects who had doubling of the interstitial or any end stage renal disease (ESRD) not attributed to interstitial fibrosis and tubular atrophy (IF/TA)|Baseline and 5 Years Post Transplant|Number of subjects who had baseline and exit biopsy samples that could be analyzed for doubling of cortical interstitial volume expansion or graft loss from IF/TA.||Participants|||Count of Participants
702119|NCT00067990|Primary|Doubling of Interstitium or Any ESRD|Doubling of the interstitial or any defined ESRD (including IF/TA)|Baseline to 5 years|||Participants|||Count of Participants
702120|NCT00068107|Secondary|Doppler Skin Blood Flow||10 years|Doppler skin blood flow was not collected in this study because it was judged to not be useful early in the study.|||||
702121|NCT00068107|Secondary|Quantitative Sensory Testing|For quantitative sensory testing, the outcome variable (detection threshold score) was analyzed for all combinations of location (foot, hand, and thigh) and test (cold, vibration, and warm). Possible threshold scores may range from 1-25. Score values of “>25” were set to 25. Higher scores indicate higher sensory detection threshold. Therefore, lower score is better. Time, measured in years, was centered at the date in which patients switched treatment regimen. All available measurements were used. A linear mixed model analysis was used to test for differences in the linear association between time and detection threshold score pre-and-post ERT regiment change while accounting for the correlation among observations from the same individual. Specifically, the model contained a subject specific random intercept with year as a fixed effect and knot at time of the treatment change.|pre-study was 2-4 years, during study sensory testing measured for approx. 4.5-5 years|Number of participants with a sufficient number of data points to estimate slope||units on a scale/year||Standard Error|Mean
702122|NCT00068107|Secondary|Number of Participants With a Change in Quantitative Sudomotor Axon Reflex Test|Quantitative sudomotor axon reflex test (QSART) is a measure of sweat function|Baseline and last observation (up to 10 years)|||participants|||Number
702123|NCT00068107|Secondary|Globotriaosylceramide (Gb(3)) in Urine Sediment||Baseline and last observation (up to 10 years)|||nanomole/(gram of Creatinine)|||Number
702124|NCT00068107|Secondary|Globotriaosylceramide (Gb(3)) in Plasma||Baseline and last observation (up to 10 years)|||nanomole/mL|||Number
702125|NCT00068107|Primary|Estimated Glomerular Filtration Rate (eGFR)|The rate of decline in renal function, as measured by estimation of glomerular filtration rate at baseline when participants were receiving agalsidase alfa (Relagal) every 2 weeks and when participants were receiving weekly infusion of Relagal.|Relagal was administered every 2 weeks for 2-4 years pre-study, Relagal was administred weekly during the study (approx. 4.5-10 years)|||ml/min/month||Standard Deviation|Mean
702126|NCT00068237|Secondary|Overall Survival||From registration to date of death or last follow-up||||||
702127|NCT00068237|Secondary|Disease-free Survival||From registration to date of failure (local or regional persistence/relapse or distant metastasis or second primary tumor or death) or last follow-up||||||
702128|NCT00068237|Secondary|Toxicity||From start of treatment to last follow-up||||||
702129|NCT00068237|Secondary|Quality of Life||From registration to 1 year||||||
702130|NCT00068237|Secondary|Salivary Scan Evaluation||From start of treatment to 6 months||||||
702131|NCT00068237|Secondary|Rate of Acute Xerostomia||From start of treatment to 90 days||||||
702132|NCT00068237|Primary|"Number of Patients Scored as Having the Surgical Technique of Submandibular Salivary Gland Transfer Performed Per Protocol"|"Surgery will be scored as per protocol prescription if scored as such by both central reviewers- the Study Chair and the Radiation Therapy Oncology Group Head and Neck Committee Surgical Chair. If 21 or more of 43 subjects are scored as having surgery per protocol prescription, then the technique will be considered reproducible with 80% power and 5% type I error using Simon's two stage design with unacceptable/acceptable rates set at 60%/80%."|At the time of the submandibular salivary gland transfer|Eligible patients who started study treatment.||participants|||Number
702149|NCT00068419|Secondary|Toxicity as Assessed by the National Cancer Institute Common Toxicity Terminology for Adverse Events v3.0||Up to 12 months||||||
702133|NCT00068341|Secondary|Pathologic Nodal Status|According to Primary Tumor Response Pathologic lymph node status N0 Axillary and other nearby lymph nodes do not have cancer (when looked at under a microscope) N1 Micrometastases (very small clusters of cancer) OR 1–3 axillary lymph nodes have cancer AND/OR Internal mammary nodes have tiny amounts of cancer found on sentinel node biopsy N2 4–9 axillary lymph nodes have cancer OR Internal mammary nodes have cancer, but axillary lymph nodes do not have cancer N3 10 or more axillary lymph nodes have cancer OR Infraclavicular (under the clavicle) nodes have cancer OR Internal mammary nodes have cancer plus 1 or more axillary lymph nodes have cancer OR 4 or more axillary lymph nodes have cancer plus internal mammary nodes have cancer or micrometastases found on sentinel node biopsy OR Supraclavicular (above the clavicle) nodes have cancer|5 years|only 71 subjects of the 74 subjects could be analyzed for this outcome measure due to data collection error.||participants|||Number
702134|NCT00068341|Secondary|Clinico-histologic Predictors of pCR (Pathologic Complete Response)||5 years|ER (estrogen-receptor), PR (progesterone-receptor), HER2 (human epidermal growth factor receptor 2), FISH (Fluorescence in situ hybridization), IDC (invasive ductal carcinoma), ILC (invasive lobular carcinoma),||participants|||Number
702135|NCT00068341|Secondary|Tumor Response Assessment|Measured by physical examination compared to breast mammography and MRI assessment|5 years|"pCR was not assessed for 2 patients in the HER2 - (Pre-Op TC) group [1 protocol violation, 1 bilateral disease] and for
1 patient in the HER2+ (Pre-Op TC, Post-Op Herceptin) group [protocol violation]"||participants|||Number
702136|NCT00068341|Secondary|Clinical Tumor Response by Physical Exam and Imaging Studies||5 years|Clinical response was not assessed for 2 patients in the HER2 - (Pre-Op TC) group [1 protocol violation, 1 bilateral disease] and for 1 patient in the HER2+ (Pre-Op TC, Post-Op Herceptin) group [protocol violation]||participants|||Number
702137|NCT00068341|Primary|Evaluate the Objective Response Rate of Patients Treated With Taxotere/Carboplatin With or Without Herceptin Preoperatively.|"Objective response rate of patients treated with Taxotere/carboplatin with or without Herceptin preoperatively. Objective response equals the combination of complete response (CR), partial response (PR) and marginal response (MR).
Tumor size was assessed by (1) physical examination, (2) mammography and (3) MRI. 5 response groups: complete response (CR), partial response (PR), marginal response (MR), stable disease (SD) & disease progression (DP). Pathologic response assigned into 2 groups: pCR and non-pCR. pCR-no evidence of residual invasive disease in specimen."|5 years|pCR was not assessed for 2 patients in the HER2 - (Pre-Op TC) group [1 protocol violation, 1 bilateral disease] and for 1 patient in the HER2+ (Pre-Op TC, Post-Op Herceptin) group [protocol violation]||participants|||Number
702138|NCT00068380|Primary|Baseline Gene Expression Levels of the Target Genes (PDGF-R and PDGF), Genes Associated With Induction of Apoptosis (Bcl-2, Bax), and Cell Cycle Regulatory Genes (p53, p21, p27|Will summarized overall and according to response and toxicity (if numbers permit), using medians, quartiles and ranges – or if a transformation is found to render the data compatible with the normal assumptions, with means, standard deviations, and confidence intervals. The association with progression-free survival or overall survival will be assessed by dichotomizing the measures of gene expression at the median (or by previously established cut-points) and constructing Kaplan-Meier plots.|Baseline||||||
702139|NCT00068380|Primary|Time to Progression|Will be summarized using the Kaplan-Meier product-limit estimators.|From first day of treatment to the first observation of disease progression or death due to disease, assessed up to 6 years||||||
702140|NCT00068380|Primary|Overall Survival|Will be summarized using the Kaplan-Meier product-limit estimators.|From first day of treatment to time of death due to any cause, assessed up to 30 days post-treatment||||||
702141|NCT00068380|Primary|Progression-free Survival||From first day of treatment to the first observation of disease progression or death due to any cause, assessed up to 30 days post treatment||||||
702142|NCT00068380|Primary|Toxicity in Terms of Type (Organ Affected or Laboratory Determination Such as Absolute Neutrophil Count), Severity (by NCI Common Toxicity Criteria and Nadir or Maximum Values for the Laboratory Measures), Time of Onset, Duration, and Reversibility|Tables will be created to summarize these toxicities by type and severity. Baseline information (e.g. the extent of prior therapy) and demographic information will be presented, as well, to describe the patients treated in this Phase II study.|Up to 30 days post treatment||||||
702143|NCT00068380|Primary|Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by X-Ray, MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Up to 6 years|||percentage of patients responding|||Number
702144|NCT00068393|Secondary|Progression-free Survival|Progression-free survival is defined as time from study entry until disease progression or death from any cause, whichever occurs first. Progression is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s) or unequivocal progression of existing nontarget lesions.|Every 8 weeks during treatment; then every 3 months if <2 years from study entry; then every 6 months if 2-3 years from study entry|Only eligible and treated patients are included in this analysis.||Months||95% Confidence Interval|Median
702145|NCT00068393|Secondary|Overall Survival|Overall survival is defined as the time from study entry until death from any cause.|Every 2 weeks during treatment; then every 3 months if <2 years from study entry; then every 6 months if 2-3 years from study entry|Only eligible and treated patients are included in this analysis.||Months||95% Confidence Interval|Median
702146|NCT00068393|Primary|Response Rate by Solid Tumor Response Criteria (RECIST)|Per RECIST criteria, Complete response (CR)= disappearance of all target and nontarget lesions Partial response (PR)= >=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits. Objective response = CR + PR|Every 8 weeks during treatment; then every 3 months if <2 years from study entry; then every 6 months if 2-3 years from study entry|Only eligible and treated patients are included in this analysis.||Percentage of Participants||90% Confidence Interval|Number
702147|NCT00068419|Secondary|Changes in Magnetic Resonance Imaging (MRI) Signal Features|MRI must include images in at least two planes with (a) pre-contrast images with the following pulse sequences T-1 weighted, fast spin echo T-2 weighted with fat saturation, and a short tau inversion recovery (STIR); and (b) post-contrast images with T-1 weighted pulse sequence with fat suppression.|From baseline to up to 5 years||||||
702150|NCT00068419|Primary|Event-free Survival|Two-year event-free survival (EFS). Events include disease progression (increase in the greatest product of 2 perpendicular diameters of any lesion by > 25% or new biopsy-proven lesions), and death in absence of disease progression. Reported as Kaplan-Meier estimate of two-year EFS proportion.|Study enrollment until time of disease progression or death as a first event (maximum follow-up 5 years)|All eligible patients.||percentage of participants||95% Confidence Interval|Number
702151|NCT00068575|Primary|Median Overall Survival (OS)|Overall Survival defined overall survival time, measured from date of tissue diagnosis till disease progression or death.|Participants followed till disease progression or death (approximately 6 years)|Analysis by protocol.||months||95% Confidence Interval|Median
702152|NCT00068588|Primary|Response Rate of a Combination of GTI-2040 and Capecitabine|Following the dose escalation step, additional patients will be accrued at the MTD and evaluated for disease response using RECIST v1.0 criteria. Patients with confirmed complete or partial response are considered to have responded favorably to treatment.The sample size and early stopping for futility was governed by a two stage Optimum design suggested by Simon. It was assumed that a true response rate less than 25% would not warrant further study of this agent. It was also assumed that a response rate of 45% would be considered promising. In the first stage (following the dose escalation step), 15 evaluable patients were treated. Four or fewer observed responses, would stop accrual, while 5 or more observed would continue accrual for an additional 12 patients during the second stage of the study. Ten or more responses out of 27 patients will be considered evidence warranting further study of the regimen providing toxicity and survival also appear favorable.|Up to 6 years|Response Rate was only assessed at the determined MTD. Additional patients were accrued to determine treatment efficacy at the MTD.||percentage of patients responding|||Number
702153|NCT00068588|Primary|Maximum Tolerated Dose Determined by Dose-limiting Toxicities|1st 3 pts will be treated on arm 2. If 0/3 DLTs observed, the dose will be escalated to arm 3. If 1/3 DLTs onserved on arm 2, 3 more pts will be treated on arm 2. If no additional DLTs are observed on arm 2, the dose will be escalated to arm 3. If at most 1/6 DLTs observed on arm 3, arm 3 will be considered the MTD. If more than 1/6 DLTs observed on arm 3, the dose will be de-escalated to arm 2. If at most 1/6 DLTs observed on arm 2, arm 2 will be considered the MTD. If more than 1/6 pts on arm 2 experience a DLT, the dose will be de-escalated to arm 1. The remaining pts will be treated on arm 1 as the MTD, unless more than 1/6 DLTs, in which case the study will stop. DLT is defined as any grade III or IV non-hematologic toxicity (incl. diarrhea w\ adequate antidiarrheal treatment & hydration & nausea/vomiting w\ maximal antiemetic prophylaxis, as per protocol) or grade IV hematologic toxicity. DLT will be based on the 1st course of treatment according to the revised NCI CTC v 2.0|21 days|||Patients experiencing DLT|||Number
702154|NCT00068601|Secondary|Rate of Ovarian Dysfunction at 1 Year|Ovarian dysfunction is defined as amenorrhea for the preceding three months and the presence of FSH, estradiol and/or inhibin B levels in the postmenopausal range.|1 year|Patients with both menstrual status data and at least two available laboratory values (FSH, inhibin B, or estradiol levels) at year 1||Participants|||Count of Participants
702155|NCT00068601|Other Pre-specified|Ovarian Reserve at 1 and 2 Years|"Measurements of ovarian reserve will consist of Day 2 - 4 levels of FSH, estradiol and inhibin B during Month 12/13 and Month 24/25 (or if amenorrheic, anytime during Month 12/13 and Month 24/25)."|1 and 2 years||||||
702156|NCT00068601|Secondary|Rate of Ovarian Dysfunction at 2 Years|Ovarian dysfunction is defined as amenorrhea for the preceding three months and the presence of FSH, estradiol and/or inhibin B levels in the postmenopausal range.|2 years|Patients with both menstrual status data and at least two available laboratory values (FSH, inhibin B, or estradiol levels) at year 2||Participants|||Count of Participants
702157|NCT00068601|Primary|Rate of Premature Ovarian Failure at 2 Years|Ovarian failure at two years is defined as amenorrhea (absence of menstrual bleeding) for the preceding six months AND the presence of follicle-stimulating hormone (FSH) in the post-menopausal range.|2 years|Patients who completed the study||Participants|||Count of Participants
702158|NCT00068718|Secondary|Progression-free Survival|Percentage of patients with progression-free survival|1 year after DLI|||percentage of participants|||Number
702159|NCT00068718|Secondary|Overall Survival|Percentage patients surviving 1 year post-transplant.|1 year after DLI|||percentage of participants|||Number
702160|NCT00068718|Secondary|Incidence of Infections in Patients Undergoing DLI Following a Non-myeloablative Transplant|Percentage of Participants with infections.|100 days after DLI|||percentage of participants|||Number
702161|NCT00068718|Secondary|Incidence of Grade II-IV GVHD in Patients Undergoing DLI Following a Non-myeloablative Transplant|Percentage of Participants with II-IV Acute GVHD|100 days after DLI|||percentage of participants|||Number
702162|NCT00068718|Secondary|Incidence of Relapse/Progression|"CML New cytogenetic abnormality and/or development of accelerated phase or blast crisis. The criteria for accelerated phase will be defined as unexplained fever >38.3°C, new clonal cytogenetic abnormalities in addition to a single Ph-positive chromosome, marrow blasts and promyelocytes >20%.
CMML, AML, ALL >30% BM blasts w/ deteriorating performance status, or worsening of anemia, neutropenia, or thrombocytopenia.
CLL ≥1 of: Physical exam/imaging studies ≥50% increase or new, circulating lymphocytes by morphology and/or flow cytometry ≥50% increase, and lymph node biopsy w/ Richter’s transformation.
NHL >25% increase in the sum of the products of the perpendicular diameters of marker lesions, or the appearance of new lesions.
MM
≥100% increase of the serum myeloma protein from its lowest level, or reappearance of myeloma peaks that had disappeared w/ treatment; or definite increase in the size or number of plasmacytomas or lytic bone lesions."|1 year after DLI|||percentage of participants|||Number
702163|NCT00068718|Secondary|Incidence of Graft Rejection|Percentage patients with graft rejection.|100 days after DLI|||percentage of participants|||Number
702164|NCT00068718|Primary|Safety of DLI Following a Non-myeloablative Transplant, Defined as Incidence of Grade IV Acute GVHD|Percentage of Participants with Grade IV Acute GVHD|100 days after DLI|||percentage of participants|||Number
702165|NCT00068770|Secondary|Overall Survival|duration of survival when celecoxib is administered concurrently with radiation in pts with newly diagnosed glioblastoma multiforme|date pt started treatment to date pt last known alive|latest survial data was obtained on May 30, 2006. 31/35 pts had died (89%) 21 in the +EIASD group and 10 in -EIASD group||months||95% Confidence Interval|Mean
706229|NCT00113516|Secondary|VEGF-C Concentration at Baseline|Concentration of VEGF-C at baseline.|Baseline (Cycle 1, Day 1) of Part 2|MITT. Number of participants analyzed = number of subjects with VEGF-C data at Baseline.||pg/mL||Standard Deviation|Mean
702166|NCT00068770|Primary|Effects of Hepatic Enzyme Inducing Drugs Such as Anticonvulsants, on the PK of Celecoxib|subjects will take one dose of celecoxib and will then have 6 hours of blood draws, day 2 subject will take 2 doses of celecoxib 8 hours apart with 2 additional blood samples, one hour apart. Subject, will continue to take 2 doses of celecoxib for 6 weeks, with a sample (PK) drawn every week prior to the first dose of the week. Comparison of Cmax of Celecoxib is reported|First dose of celecoxib through completion of radiation, 6 weeks.|"pts who had PK data for the first dose of celecoxib. observations were excluded if sample was not collected within 12 +/- 2h after taking prior dose, was drawn after dosing on same day or determine to be outlier by dixon's test.
PK data was available for 15 pts in the +EIASD group and 12 pts in the -EIASD group"||(ng/ml)||Standard Deviation|Geometric Mean
702167|NCT00068822|Primary|Patient's Rating of Average Pain at 1 Month|Patient's rating of average pain intensity during the preceding 24 hours at 1 month. The rating scale was from 0 to 10, with higher scores indicating more severe pain.|1 month|68 subjects were randomized to undergo vertebroplasty and 63 to undergo the control intervention. All underwent the assigned intervention. One subject in the vertebroplasty group and two subjects in the control group were lost to follow-up before 1 month.||units on a scale||Standard Deviation|Mean
702168|NCT00068822|Secondary|Patient Well-being at 1 Month|"Patient well-being was quantified by these tools: Health status outcome using Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36). Scores on the Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36), version 2. Subjects completed the SF-36 which consists of 8 sub-scales which are additionally summarized into 2 summary components (physical and mental). The subscales and the summary scales both range from 0 to 100, with (0 = worst imaginable, 100 = best imaginable).
Pain Frequency Index, Pain Bothersome Index (scores range from 0-4, higher scores indicating more severe pain).
European Quality of Life (QOL) 5 Dimensions (EQ-5D), scale range -0.1 to 1.0; higher scores indicating a better QOL.
Study of Osteoporotic Fractures-Activities of Daily Living (SOF ADL6) range from 0 to 18; higher scores = more back-related disability."|Month 1|68 subjects were randomized to undergo vertebroplasty and 63 to undergo the control intervention. All underwent the assigned intervention. One subject in the vertebroplasty group and two subjects in the control group were lost to follow-up before 1 month.||units on a scale||Standard Deviation|Mean
702169|NCT00068822|Primary|Back-specific Functional Status Using Roland-Morris Disability Questionnaire (RDQ) Scale at 1 Month|Back-specific functional status using RDQ scale range from 0 (no pain) to 23, with higher scores indicating more severe disability.|1 month after procedure|68 subjects were randomized to undergo vertebroplasty and 63 to undergo the control intervention. All underwent the assigned intervention. One subject in the vertebroplasty group and two subjects in the control group were lost to follow-up before 1 month.||units on a scale||Standard Deviation|Mean
702170|NCT00069095|Secondary|Duration of Complete Response as Assessed by the Investigator According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone|For complete responders, the duration of complete response was measured from the time measurement criteria were first met for complete response until the date that progressive disease (or death) was documented. Superiority of the BV-containing arms was compared with the chemotherapy alone arms.|From baseline until disease progression/recurrence, approximately 2 years 6 months|The ITT population included all randomized participants who provided written informed consent.||days||95% Confidence Interval|Median
702171|NCT00069095|Secondary|Duration of Complete Response as Assessed by the Investigator According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4|For complete responders, the duration of complete response was measured from the time measurement criteria were first met for complete response until the date that progressive disease (or death) was documented. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.|From baseline until disease progression/recurrence, approximately 2 years 6 months|The EPP excluded participants from the ITT who had violated major protocol inclusion or exclusion criteria or participants who were randomized and did not receive at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.||days||95% Confidence Interval|Median
702172|NCT00069095|Secondary|Duration of Overall Response as Assessed by the Investigator According to RECIST: Superiority Analysis of Chemotherapy Plus Bevacizumab Versus Chemotherapy Alone|Duration of overall response was measured from the time that measurement criteria were first met for CR or PR (whichever status was recorded first) until the first date when progressive disease or death was documented. It was based on tumor assessments made by the investigators according to the RECIST criteria. Participants who neither progressed nor died were censored at the date of the last tumor assessment. Participants undergoing surgical resection with curative intent were censored at the date of surgery. Superiority of the BV-containing arms was compared with the chemotherapy alone arms.|From baseline until disease progression/recurrence, approximately 2 years 6 months|The ITT population included all randomized participants who provided written informed consent.||days||95% Confidence Interval|Median
702173|NCT00069095|Secondary|Duration of Overall Response as Assessed by the Investigator According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4|Duration of overall response was measured from the time that measurement criteria were first met for CR or PR (whichever status was recorded first) until the first date when progressive disease or death was documented. It was based on tumor assessments made by the investigators according to the RECIST criteria. Participants who neither progressed nor died were censored at the date of the last tumor assessment. Participants undergoing surgical resection with curative intent were censored at the date of surgery. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.|From baseline until disease progression/recurrence, approximately 2 years 6 months|The EPP excluded participants from the ITT who had violated major protocol inclusion or exclusion criteria or participants who were randomized and did not receive at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.||days||95% Confidence Interval|Median
702174|NCT00069095|Secondary|Time to Response as Assessed by the Investigator According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone|For participants whose BOR was CR or PR, time to response was measured as the time from randomization to the first time when the measurement criteria for CR or PR (whichever status was recorded first) was met. It was based on tumor assessments made by the investigators according to the RECIST criteria. Results were reported as the number of participants achieving a response in 8 time categories from Week 1 to Week 54. Superiority of the BV-containing arms was compared with the chemotherapy alone arms.|Week 1 to Week 54|The ITT population included all randomized participants who provided written informed consent.||Participants|||Number
702175|NCT00069095|Secondary|Time to Response as Assessed by the Investigator According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4|For participants whose BOR was CR or PR, time to response was measured as the time from randomization to the first time when the measurement criteria for CR or PR (whichever status was recorded first) was met. It was based on tumor assessments made by the investigators according to the RECIST criteria. Results were reported as the number of participants achieving a response in 8 time categories from Week 1 to Week 54. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.|Week 1 to Week 54|The EPP excluded participants from the ITT who had violated major protocol inclusion or exclusion criteria or participants who were randomized and did not receive at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.||Participants|||Number
702176|NCT00069095|Secondary|Time to Treatment Failure as Assessed by the Investigator According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone|Time to treatment failure was defined as the time from the date of randomization to the date of discontinuation of the primary study treatment phase due to adverse event/intercurrent illness, insufficient therapeutic response, death, failure to return, refusing treatment/being unwilling to cooperate, or withdrawing consent; discontinuation of the post study treatment phase due to adverse event, progressive disease, death, participant refusal/administrative reasons, or withdrawing consent; documented disease progression; or death due to any cause, whichever occurred first. The general approach included all tumor assessments or deaths that occurred during the primary study treatment phase, the post-study treatment phase, or the follow-up phase. The on-treatment approach included only tumor assessments and deaths that occurred no later than 28 days after the last confirmed intake of any study medication in the primary study treatment phase only.|From baseline until disease progression/recurrence, approximately 2 years 6 months|The safety population included all participants who were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.||days||95% Confidence Interval|Median
702177|NCT00069095|Secondary|Time to Treatment Failure (TTF) as Assessed by the Investigator According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4|Time to treatment failure was defined as the time from the date of randomization to the date of discontinuation of the primary study treatment phase due to adverse event/intercurrent illness, insufficient therapeutic response, death, failure to return, refusing treatment/being unwilling to cooperate, or withdrawing consent; discontinuation of the post study treatment phase due to adverse event, progressive disease, death, participant refusal/administrative reasons, or withdrawing consent; documented disease progression; or death due to any cause, whichever occurred first. The general approach took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during the follow-up phase.The on-treatment approach included only tumor assessments and deaths that occurred no later than 28 days after the last confirmed intake of any study medication in the primary study treatment phase only.|From baseline until disease progression/recurrence, approximately 2 years 6 months|The safety population included all participants who were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.||days||95% Confidence Interval|Median
702178|NCT00069095|Secondary|BOR as Assessed by the IRC According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone|According to the RECIST criteria, the BOR in an individual participant was the best response recorded from the start of the treatment until disease progression/recurrence (taking the smallest measurements recorded since the baseline assessment as a reference for PD). The BOR as assessed by the IRC was determined based on tumor assessments that were made up to and including 28 days after last intake of study medication in the primary study treatment phase. Responders were defined as the percentage of participants with a complete response (CR) or partial response (PR). Superiority of the BV-containing arms was compared with the chemotherapy alone arms.|From baseline until disease progression/recurrence, approximately 2 years 6 months|The ITT population included all randomized participants who provided written informed consent.||Percentage of responders|||Number
702179|NCT00069095|Secondary|BOR as Assessed by the IRC According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4|According to the RECIST criteria, the BOR in an individual participant was the best response recorded from the start of the treatment until disease progression/recurrence (taking the smallest measurements recorded since the baseline assessment as a reference for PD). The BOR as assessed by the IRC was determined based on tumor assessments that were made up to and including 28 days after last intake of study medication in the primary study treatment phase. Responders were defined as the percentage of participants with a complete response (CR) or partial response (PR). Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.|From baseline until disease progression/recurrence, approximately 2 years 6 months|The EPP excluded participants from the ITT who had violated major protocol inclusion or exclusion criteria or participants who were randomized and did not receive at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.||Percentage of responders|||Number
702180|NCT00069095|Secondary|Best Overall Response (BOR) as Assessed by the Investigator According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone|According to the RECIST criteria, BOR in an individual participant was defined as the best response recorded from the start of the treatment until disease progression or recurrence. Only tumor assessments as assessed by the investigator and made up to and including 28 days after last intake of study medication in the primary study treatment phase not later than date of first curative surgery were included in these analyses. Responders were defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR). Superiority of the BV-containing arms was compared with the chemotherapy alone arms.|From baseline until disease progression/recurrence, approximately 2 years 6 months|The ITT population included all randomized participants who provided written informed consent.||Percentage of responders|||Number
702195|NCT00069108|Secondary|Time To Response|Time to response (TOR) (best response of CR or PR) was measured as the time from randomization to the first date on which the measurement criteria for CR or PR (whichever status was recorded first) were met. CR for TLs was defined as disappearance of all TLs and for non-TLs as disappearance of all non-TLs and normalization of tumor marker level. PR was defined as at least 30% decrease in the sum of the LD of TLs, taking as reference the baseline sum LD.|Up to 3 years|All participants who were randomized to one of the two study arms were included in the ITT population. Participants in this population were analyzed according to the arm to which they were randomized.||participants|||Number
702181|NCT00069095|Secondary|Best Overall Response (BOR) as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST): Non-inferiority of XELOX Versus FOLFOX-4|According to the RECIST criteria, BOR in an individual participant was defined as the best response recorded from the start of the treatment until disease progression or recurrence. Only tumor assessments as assessed by the investigator and made up to and including 28 days after last intake of study medication in the primary study treatment phase not later than date of first curative surgery were included in these analyses. Responders were defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR). Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.|From baseline until disease progression/recurrence, approximately 2 years 6 months|The EPP excluded participants from the ITT who had violated major protocol inclusion or exclusion criteria or participants who were randomized and did not receive at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.||Percentage of responders|||Number
702182|NCT00069095|Primary|PFS as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) by General Approach (Participants With Curative Surgery Censored) - Superiority of Chemotherapy Plus BV Over Chemotherapy Alone|PFS was defined as the time from randomization to progressive disease or death. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment that confirmed that their disease had not progressed. Participants with no tumor assessments after baseline who were alive at the time of clinical cutoff were censored at the date of randomization. Participants who underwent surgical resection with curative intent without prior progression were censored at the date of surgery. PFS was based on tumor assessments made by the investigators according to the RECIST criteria. Superiority analysis that followed the general approach took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during the follow-up phase. Superiority of the BV-containing arms was compared with the chemotherapy alone arms.|Baseline until disease progression or death, approximately 2 years 6 months|The ITT population included all randomized participants who provided written informed consent.||days||95% Confidence Interval|Median
702183|NCT00069095|Secondary|Overall Survival: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone|Overall survival was defined as the time from the date of randomization to the date of death. Participants who were not reported to have died at the time of the clinical cut-off date for the analysis were censored using the date they were last known to be alive. Superiority of the BV-containing arms was compared with the chemotherapy alone arms.|Baseline until disease progression or death, approximately 2 years 6 months|The ITT population included all randomized participants who provided written informed consent.||days||95% Confidence Interval|Median
702184|NCT00069095|Secondary|Overall Survival: Non-inferiority of XELOX Versus FOLFOX-4|Overall survival was defined as the time from the date of randomization to the date of death. Participants who were not reported to have died at the time of the clinical cut-off date for the analysis were censored using the date they were last known to be alive. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.|Baseline until disease progression or death, approximately 2 years 6 months|The EPP excluded participants from the ITT who had violated major protocol inclusion or exclusion criteria or participants who were randomized and did not receive at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.||days||95% Confidence Interval|Median
702185|NCT00069095|Secondary|PFS by General Approach, Participants With Curative Surgery Not Censored: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone|PFS is defined as the time from randomization to disease progression (PD) or death due to any cause. Participants who underwent curative surgery after experiencing a sufficient shrinkage of their tumor were not censored at the date of surgery, but any relapse, new occurrence of colorectal cancer, or death was considered as an event. Superiority analysis that followed the general approach took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during the follow-up phase. Superiority of the BV-containing arms was compared with the chemotherapy alone arms.|Baseline until disease progression or death, approximately 2 years 6 months|The ITT population included all randomized participants who provided written informed consent.||days||95% Confidence Interval|Median
702186|NCT00069095|Secondary|PFS by General Approach, Participants With Curative Surgery Not Censored: Non-inferiority of XELOX Versus FOLFOX-4|PFS is defined as the time from randomization to disease progression (PD) or death due to any cause. Participants who underwent curative surgery after experiencing a sufficient shrinkage of their tumor were not censored at the date of surgery, but any relapse, new occurrence of colorectal cancer, or death was considered as an event. Non-inferiority analysis that followed the general approach took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during the follow-up phase. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.|Baseline until disease progression or death, approximately 2 years 6 months|EPP excluded participants from the ITT who had violated major protocol inclusion or exclusion criteria or participants who were randomized and did not receive at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.||days||95% Confidence Interval|Median
702187|NCT00069095|Secondary|PFS (On-treatment Approach): Superiority of Chemotherapy Plus BV Over Chemotherapy Alone|PFS is defined as the time from randomization to disease progression (PD) or death due to any cause. The on-treatment analysis included only tumor assessments and death events that occurred no later than 28 days after the last confirmed intake of any study medication in the primary study treatment phase. Participants who did not have an event during this interval were censored at the date of the last tumor assessment within this time window, or on day 1 if no tumor assessment was available after baseline. Participants who underwent surgical resection with curative intent without prior progression within 28 days after the last confirmed intake of any study medication in the primary study treatment phase were censored at the date of surgery. The on-treatment approach excluded the possible impact of other treatments that might have been started before disease progression. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.|Baseline until disease progression or death, approximately 2 years 6 months|The ITT population included all randomized participants who provided written informed consent.||days||95% Confidence Interval|Median
703674|NCT00095498|Secondary|Change From Baseline in Eosinophils at Month 3|Laboratory hematology eosinophils|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.||* 10^9/L||Standard Deviation|Mean
702188|NCT00069095|Secondary|PFS (On-treatment Approach): Non-inferiority of XELOX Versus FOLFOX-4|PFS is defined as the time from randomization to disease progression (PD) or death due to any cause. The on-treatment analysis included only tumor assessments and death events that occurred no later than 28 days after the last confirmed intake of any study medication in the primary study treatment phase. Participants who did not have an event during this interval were censored at the date of the last tumor assessment within this time window, or on day 1 if no tumor assessment was available after baseline. Participants who underwent surgical resection with curative intent without prior progression within 28 days after the last confirmed intake of any study medication in the primary study treatment phase were censored at the date of surgery. The on-treatment approach excluded the possible impact of other treatments that might have been started before disease progression. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.|Baseline until disease progression or death, approximately 2 years 6 months|The EPP excluded participants from the ITT who had violated major protocol inclusion or exclusion criteria or participants who were randomized and did not receive at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.||days||95% Confidence Interval|Median
702189|NCT00069095|Secondary|PFS as Assessed by the Independent Review Committee (IRC) (General Approach, Participants With Curative Surgery Censored) - Superiority of Chemotherapy Plus BV Over Chemotherapy Alone|PFS is defined as the time from randomization to disease progression (PD) or death due to any cause. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment that confirmed that their disease had not progressed. Participants who underwent surgical resection with curative intent without prior progression were censored at the date of surgery. PFS was analyzed on the basis of the tumor response assessments made by the IRC. Superiority analysis that followed the general approach took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during the follow-up phase. Superiority of the bevacizumab-containing arms was compared with the placebo-containing arms.|Baseline until disease progression or death, approximately 2 years 6 months|The ITT population included all randomized participants who provided written informed consent.||days||95% Confidence Interval|Median
702190|NCT00069095|Secondary|PFS as Assessed by the Independent Review Committee (IRC) (General Approach, Participants With Curative Surgery Censored) - Non-inferiority of XELOX Versus FOLFOX-4|PFS is defined as the time from randomization to disease progression (PD) or death due to any cause. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment that confirmed that their disease had not progressed. Participants who underwent surgical resection with curative intent without prior progression were censored at the date of surgery. PFS was analyzed on the basis of the tumor response assessments made by the IRC. Non-inferiority analysis that followed the general approach took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during the follow-up phase. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.|Baseline until disease progression or death, approximately 2 years 6 months|The EPP excluded participants from the ITT who had violated major protocol inclusion or exclusion criteria or participants who were randomized and did not receive at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.||days||95% Confidence Interval|Median
702191|NCT00069095|Primary|Progression-free Survival (PFS) as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) by General Approach (Participants With Curative Surgery Censored): Non-inferiority of XELOX Versus FOLFOX-4|PFS was defined as the time from randomization to progressive disease or death. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment that confirmed that their disease had not progressed. Participants with no tumor assessments after baseline who were alive at the time of clinical cutoff were censored at the date of randomization. Participants who underwent surgical resection with curative intent without prior progression were censored at the date of surgery. PFS was based on tumor assessments made by the investigators according to the RECIST criteria. Non-inferiority analysis that followed the general approach took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during the follow-up phase. Non-inferiority of the XELOX-containing arms compared with the FOLFOX-4- containing arms was investigated.|Baseline until disease progression or death, approximately 2 years 6 months|The eligible patient population (EPP) excluded participants from the ITT who had violated major protocol inclusion or exclusion criteria or participants who were randomized and did not receive at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.||days||95% Confidence Interval|Median
702192|NCT00069108|Secondary|Number of Participants With Marked Post-baseline Laboratory Abnormalities by Trial Treatment|Laboratory abnormalities were defined as those values that were outside the Roche defined reference range and showed a clinically relevant change from baseline. All laboratory parameters were categorized according to the National Cancer Center Common Toxicity Criteria (NCI-CTCAE) grading system. Incidence of Grade 1 to 4 laboratory abnormalities are presented in the table below.|Up to 3 years|All participants who were randomized and received at least one dose of capecitabine, 5-FU, or oxaliplatin were included in the safety population. The safety population was used for the analyses of all safety parameters||participants|||Number
702193|NCT00069108|Secondary|Time To Treatment Failure|Time to treatment failure was defined as the time from the date of randomization to the first occurrence of adverse event (AE), insufficient therapeutic response, death, failure to return, or refusing treatment/being uncooperative/withdrawing consent.|Up to 3 years|All participants who were randomized and received at least one dose of capecitabine, 5-FU, or oxaliplatin were included in the safety population. The safety population was used for the analyses of all safety parameters.||days||95% Confidence Interval|Median
702194|NCT00069108|Secondary|Duration Of Response|Duration of response (DOR) is defined as the time when CR or PR was first met up to first date that PD or death is documented. CR is defined as disappearance of all TLs and non TLs, PR is defined as at least 30% decrease in the sum of the LD of TLs, taking as reference the baseline sum LD. PD was defined as at least a 20% increase in the sum of the LD of the TLs, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions for the TLs or the appearance of one or more new lesions and/or unequivocal progression of existing non-TLs.|Up to 3 years|All participants who were randomized to one of the two study arms were included in the Intent-to-treat (ITT) population. Participants in this population were analyzed according to the arm to which they were randomized.||days||95% Confidence Interval|Median
702196|NCT00069108|Secondary|Overall Survival|Overall survival was measured as the time from the date of randomization to the date of death. Participant who were not reported to have died at the time of the analysis were censored using the date they were last known to be alive.|Up to 3 years|All participants who were randomized to one of the two study arms were included in the ITT population. Participants in this population were analyzed according to the arm to which they were randomized.||days||95% Confidence Interval|Median
702197|NCT00069108|Secondary|Best Overall Response, Independent Review Committee Assessment|Best overall response is best response recorded from start of treatment until disease progression/recurrence where responses include CR, PR, or SD. CR was defined as disappearance of all TLs, non-TLs along with normalization of tumor marker level. PR is at least 30% decrease in sum of the LD of TLs, taking as reference baseline sum LD. SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking reference of smallest sum LD since treatment started. It was dependent on achievement of measurement and confirmation criteria. BOR .i.e. CR or PR was confirmed by repeat assessments performed within 4 weeks, for SD, follow-up assessments had to meet the SD criteria at least once after study entry within 6 to 8 weeks. This PFS evaluation was based on Independent Review Committee Assessment.|Up to 3 years|All participants who were randomized to one of the two study arms were included in the ITT population. Participants in this population were analyzed according to the arm to which they were randomized.||participants|||Number
702198|NCT00069108|Secondary|Best Overall Response, Investigators’ Assessments|Best overall response is best response recorded from start of treatment until disease progression/recurrence where responses include complete response (CR), partial response (PR), or stable disease (SD). CR was defined as disappearance of all TLs, non-TLs along with normalization of tumor marker level. PR is at least 30% decrease in sum of the LD of TLs, taking as reference baseline sum LD. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking reference of smallest sum LD since treatment started. It was dependent on achievement of measurement and confirmation criteria. BOR .i.e. CR or PR was confirmed by repeat assessments performed within 4 weeks. For SD, follow-up assessments had to meet the SD criteria at least once after study entry within 6 to 8 weeks.|Up to 3 years|All participants who were randomized to one of the two study arms were included in the ITT population. Participants in this population were analyzed according to the arm to which they were randomized.||participants|||Number
702199|NCT00069108|Secondary|Progression Free Survival Based on Treatment Analysis- Per Population|Progression free survival (PFS) is defined as the time from the date of randomization to the day of documented disease progression or death from any cause. It was based on tumor assessments made according to the RECIST version 1.0, wherein PD was defined as at least a 20% increase in the sum of the LD of the TLs, taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more new lesions or unequivocal progression of existing non-TLs. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment confirming that they had not progressed. Participants with no tumor assessments after baseline but who were still alive at the time of the clinical cut-off were censored at date of randomization|Up to 3 years|The PP population included randomized participants who received at least one dose of Capecitabine, 5-FU, or Oxaliplatin, or who did not had a major violation of protocol inclusion or exclusion criteria assessments.||days||95% Confidence Interval|Median
702200|NCT00069108|Secondary|Progression Free Survival Based on Treatment Analysis- Intent To Treat Population|Progression free survival (PFS) is defined as the time from date of randomization to day of documented disease progression or death from any cause. It was based on tumor assessments made according to the RECIST version 1.0, wherein PD was defined as at least a 20% increase in the sum of LD of the TLs, taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more new lesions or unequivocal progression of existing non-TLs. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment confirming that they had not progressed. Participants with no tumor assessments after baseline but who were still alive at the time of the clinical cut-off were censored at date of randomization. PFS was analyzed using an on-treatment approach included only disease progression and death that occurred no later than 28 days after the last confirmed intake of study medication in the primary study treatment phase.|Up to 3 years|All participants who were randomized to one of the two study arms were included in the Intent To Treat (ITT) population. Participants were analyzed according to the arm to which they were randomized.||days||95% Confidence Interval|Median
702201|NCT00069108|Secondary|Progression Free Survival Based on Independent Review Committee Assessment|Progression free survival (PFS) is defined as the time from the date of randomization to the day of documented disease progression or death from any cause. It was based on tumor assessments made according to the RECIST version 1.0, wherein PD was defined as at least a 20% increase in the sum of the LD of the TLs, taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more new lesions or unequivocal progression of existing non-TLs. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment confirming that they had not progressed. Participants with no tumor assessments after baseline but who were still alive at the time of the clinical cut-off were censored at date of randomization. This PFS evaluation was based on Independent Review Committee Assessment.|Up to 3 years|PP population excluded randomized participants who did not receive at least one dose of Capecitabine, 5-FU, or Oxaliplatin, or who had a major violation of protocol inclusion or exclusion criteria.||days||95% Confidence Interval|Median
702202|NCT00069108|Primary|Progression Free Survival|Progression free survival (PFS) is defined as the time from the date of randomization to the day of documented disease progression or death from any cause. It was based on tumor assessments made according to the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0, wherein progressive disease (PD) was defined as at least a 20% increase in the sum of the longest diameter (LD) of the target lesions (TLs), taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more new lesions or unequivocal progression of existing non-target lesions. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment confirming that they had not progressed. Participants with no tumor assessments after baseline but who were still alive at the time of the clinical cut-off were censored at date of randomization|Up to 3 years|The per protocol (PP) population included randomized participants who received at least one dose of capecitabine, 5-FU, or oxaliplatin, or who did not had a major violation of protocol inclusion or exclusion criteria assessments.||days||95% Confidence Interval|Median
702203|NCT00069121|Secondary|Number of Participants Assesed for Adverse Events|"Adverse events were presented in individual listings and summarized by Medical Dictionary for Regulatory Activities (MedDRA)System Organ Classes, intensity, and relation to trial treatment. Laboratory data are summarized in two ways: Summary of laboratory abnormalities (regardless of the baseline values), with particular attention to the more clinically relevant Grade 3/4 laboratory abnormalities. Summary of laboratory abnormalities as a shift from baseline.
See Adverse Events module for details."|followed from Time of Very First Drug Intake and 28 day(s) after Very Last Drug Intake|Safety Population||participants|||Number
702204|NCT00069121|Secondary|Overall Survival [Time to Event]|Survival was measured as the time from randomization to the date of death, irrespective of the cause of death. Patients who were not reported as having died at the time of the analysis were censored using the date they were last known to be alive.|Time from randomization date to date of death/date last known to be alive. Median observation time for was approx 59 mos.|Intent-to-Treat Population||months||95% Confidence Interval|Median
702205|NCT00069121|Secondary|Overall Survival [Number of Events]|Survival was measured as the time from randomization to the date of death, irrespective of the cause of death. Patients who were not reported as having died at the time of the analysis were censored using the date they were last known to be alive.|Time from randomization date to date of death/date last known to be alive. Median observation time for was approx 59 mos.|Intent-to-Treat Population||participants|||Number
702206|NCT00069121|Secondary|Relapse-free Survival (RFS) [Time to Event]|Included only recurrence of the original colon cancer, development of a new colon or rectal cancer, and deaths related to any of the following: treatment, recurrence of the original colon cancer, or development of a new colon or rectal cancer. Patients who were not reported as having died at the time of the analysis were censored using the date they were last known to be relapse free.|Time from randomization date to date of first event/date last known to be event free. Median observation time for RFS was approx 57 mos.|Intent-to-Treat Population||months||95% Confidence Interval|Median
702207|NCT00069121|Primary|Disease-free Survival [Time to Event]|Determination of an event was based on tumor assessments and survival follow-up assessments. Any recurrence of the original colon cancer or appearance of a new colon or rectal cancer was to be proven by cytology or histology, when possible. An isolated event of increased CEA, or unexplained clinical deterioration were not considered to be evidence of relapse without support of other objective measurements. The date of relapse was defined as the date of the definitive assessment by objective measurements.|Time from randomization date to date of first event/date last known to be event free. Median observation time for DFS was approx 57 mos.|Intent-to-Treat Population||months||95% Confidence Interval|Median
702208|NCT00069121|Secondary|Relapse-free Survival (RFS) [Number of Events]|Included only recurrence of the original colon cancer, development of a new colon or rectal cancer, and deaths related to any of the following: treatment, recurrence of the original colon cancer, or development of a new colon or rectal cancer.|Time from randomization date to date of first event/date last known to be event free. Median observation time for RFS was approx 57 mos.|Intent-to-Treat Population||participants|||Number
702209|NCT00069121|Primary|Disease-free Survival (DFS) [Number of Events]|Number of patients with/without recurrence of the original colon cancer or appearance of a new colon or rectal cancer, or death due to any cause. Based on tumor assessments and survival follow-up assessments.|Time from randomization date to date of first event/date last known to be event free. Median observation time for DFS was approx 57 mos.|Intent-to-Treat Population||participants|||Number
702210|NCT00069160|Secondary|Percent Increase in Sestamibi Area Under Curve (AUC) in Tumor Tissue|99mTc-sestamibi is a radionuclide imaging agent used to study cardiac function that has also been shown to be a substrate for P-glycoprotein- mediated drug efflux. Because of the high expression of Pgp in liver tissue, sestamibi uptake in liver tissue is often monitored as a marker of Pgp inhibition. A significant change in the area under the curve(AUC) in liver tissue (normal tissue as a surrogate) is defined as P<0.001.|3-24 hours|||Percent||Full Range|Median
702211|NCT00069160|Secondary|Percent Increase in Sestamibi Area Under Curve (AUC) in Liver After Tariquidar|A significant change in the area under the curve(AUC) in liver tissue (normal tissue as a surrogate) is defined as P<0.001. A secondary objective of this study was to establish whether tariquidar (150 mg) modulates Pgp in liver. Sestamibi is a Pgp substrate that may be a surrogate for measuring drug efflux from tumors. A baseline Tc-sestamibi scan was obtained before the administration of tariquidar. A minimum of 48 hours later, on or about day 22 a single dose of tariquidar was administered, followed by a second Tc-sestamibi scan.|3 - 24 hours|Percent increase in sestamibi AUC in liver after tariquidar.||percent increase in sestamibi AUC||Full Range|Median
702212|NCT00069160|Primary|Clinical Response Rate|Response is determined by RECIST criteria defined as changes in only the largest diameter (unidimensional measurement) of the tumor lesion. Lesions are either measurable or non-measurable. Measurable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter to be recorded) as >/- 20 mm with conventional techniques (CT, MRI, xray) or as >/- 10 mm with a spiral CT scan. Non-measurable lesions are defined as all other lesions (or sites of disease) including small lesions (longest diameter <20 mm with conventional techniques or <10 mm using spiral CT.|4 years, 8-11 months|||Percentage of participants|||Number
702213|NCT00069160|Primary|Geometric Mean of Area Under Curve (AUC0)-24||24 hours|Docetaxel alone (C1D1 = 21 patients; C1D8 = 18 patients) Docetaxel with Tariquidar (C1D1 = 21 patients; C1D8 = 16 patients) Pharmacokinetic data were evaluable in 39 patients. Paired data from 31 participants were evaluable.||h*ng/mL||95% Confidence Interval|Geometric Mean
702214|NCT00069160|Primary|The Number of Participants With Adverse Events.|Here are the total number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|4 yrs 8-11 months|||participants|||Number
702215|NCT00069160|Primary|Geometric Mean of Maximum Concentration of the Drug (Cmax)|In the first cycle patients were to receive docetaxel on days 1 and 8 and to be randomized to receive tariquidar on either day 1 or 8. Thus pharmacokinetic data with and without tariquidar can be compared.|24 hours|Docetaxel alone (C1D1 = 21 patients; C1D8 = 18 patients) Docetaxel with Tariquidar (C1D1 = 21 patients; C1D8 = 16 patients) Data were evaluable in 39 patients. Paired data from 31 participants were evaluable.||Cmax (ng/mL)||95% Confidence Interval|Geometric Mean
702218|NCT00069264|Primary|Determination of the Maximum Tolerated Dose||28 Days|||mg/m^2|||Number
702219|NCT00069277|Primary|Response and Progression Will be Evaluated in This Study Using the New International Criteria Proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Changes in Only the Largest Diameter of the Tumor Lesions Are Used.||12 Weeks|||participants|||Number
702220|NCT00069329|Primary|Erythrocyte Sedimentation Rate (ESR) Measurement|Erythrocyte Sedimentation Rate (ESR) is an inflammatory marker for NOMID. Normal ESR values are defined as ≤ 25 mm/hour. Analyzed at the NIH Clinical Center Laboratory.|60 months|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 20 patients who completed their 5 year assessment.||mm/hour||Standard Deviation|Mean
702221|NCT00069329|Primary|Erythrocyte Sedimentation Rate (ESR) Measurement|Erythrocyte Sedimentation Rate (ESR) is an inflammatory marker for NOMID. Normal ESR values are defined as ≤ 25 mm/hour. Analyzed at the NIH Clinical Center Laboratory.|36 months|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 4.5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment.||mm/hour||Standard Deviation|Mean
702222|NCT00069329|Primary|Erythrocyte Sedimentation Rate (ESR) Measurement|Erythrocyte Sedimentation Rate (ESR) is an inflammatory marker for NOMID. Normal ESR values are defined as ≤ 25 mm/hour. Analyzed at the NIH Clinical Center Laboratory.|Baseline|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg/day per injection were made as frequently as every 2 weeks to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment.||mm/hour||Standard Deviation|Mean
702223|NCT00069329|Primary|C-reactive Protein (CRP) Measurement|C-reactive protein (CRP) is an inflammatory marker for NOMID. Systemic inflammatory remission was defined as a normal CRP level (≤0.5mg/dl). Analyzed at the NIH Clinical Center Laboratory.|60 months|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 20 patients who completed their 5 year assessment.||mg/dl||Standard Deviation|Mean
702224|NCT00069329|Primary|C-reactive Protein (CRP) Measurement|C-reactive protein (CRP) is an inflammatory marker for NOMID. Systemic inflammatory remission was defined as a normal CRP level (≤0.5mg/dl). Analyzed at the NIH Clinical Center Laboratory.|36 months|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 4.5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment.||mg/dl||Standard Deviation|Mean
702225|NCT00069329|Primary|C-reactive Protein (CRP) Measurement|C-reactive protein (CRP) is an inflammatory marker for NOMID. Systemic inflammatory remission was defined as a normal CRP level (≤0.5mg/dl). Analyzed at the NIH Clinical Center Laboratory.|Baseline|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg/day per injection were made as frequently as every 2 weeks to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment.||mg/dl||Standard Deviation|Mean
702226|NCT00069329|Primary|Serum Amyloid A (SAA) Measurement|Serum Amyloid A is an inflammatory marker for NOMID measured using Rapid Automated Enzyme Immunoassay. Normal SAA values were defined as ≤ 10 mg/liter.|60 months|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 20 patients who completed their 5 year assessment.||mg/liter||Standard Deviation|Mean
702227|NCT00069329|Primary|Serum Amyloid A (SAA) Measurement|Serum Amyloid A is an inflammatory marker for NOMID measured using Rapid Automated Enzyme Immunoassay. Normal SAA values were defined as ≤ 10 mg/liter.|36 months|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 4.5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment.||mg/liter||Standard Deviation|Mean
702228|NCT00069329|Primary|Serum Amyloid A (SAA) Measurement|Serum Amyloid A is an inflammatory marker for NOMID measured using Rapid Automated Enzyme Immunoassay. Normal SAA values were defined as ≤ 10 mg/liter.|Baseline|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg/day per injection were made as frequently as every 2 weeks to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment.||mg/liter||Standard Deviation|Mean
702229|NCT00069329|Primary|Childhood Health Assessment Questionnaire (CHAQ)|Patient self-assessment (or parent assessment) for how illness affects ability to function in daily life. Includes overall score, overall pain rating, overall global evaluation, subcategories for dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities. Measured on scale of 0-3 from 'Without any difficulty' (0) to 'Unable to do' (3).|60 months|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 20 patients who completed their 5 year assessment.||units on a scale||Standard Deviation|Mean
702300|NCT00078559|Secondary|Number of Participants Who Experienced Graft Loss Stratified by Sirolimus Withdrawal Status|"Participants who experienced graft loss[1] during study
[1]Graft loss is defined as the institution of chronic dialysis (at least 6 consecutive weeks, excluding participants with delayed graft function), transplant nephrectomy, or retransplantation"|Transplantation to Graft Loss (up to four years post-transplantation)|Intent-to-treat||participants|||Number
702230|NCT00069329|Primary|Childhood Health Assessment Questionnaire (CHAQ)|Patient self-assessment (or parent assessment) for how illness affects ability to function in daily life. Includes overall score, overall pain rating, overall global evaluation, subcategories for dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities.Measured on scale of 0-3 from 'Without any difficulty' (0) to 'Unable to do' (3).|36 months|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 4.5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment.||units on a scale||Standard Deviation|Mean
702231|NCT00069329|Primary|Childhood Health Assessment Questionnaire (CHAQ)|Patient self-assessment (or parent assessment) for how illness affects ability to function in daily life. Includes overall score, overall pain rating, overall global evaluation, subcategories for dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities. Measured on scale of 0-3 from 'Without any difficulty' (0) to 'Unable to do' (3).|Baseline|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg/day per injection were made as frequently as every 2 weeks to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment.||units on a scale||Standard Deviation|Mean
702232|NCT00069329|Primary|Parent /Patient Pain Rating|Visual Analog assessment of how much pain the patient experienced in past week due to illness as rated by the patient themselves or parent. Measured on scale from no pain (0 mm) to very severe pain (100 mm).|60 months|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 20 patients who completed their 5 year assessment.||units on a scale||Standard Deviation|Mean
702233|NCT00069329|Primary|Parent /Patient Pain Rating|Visual analog assessment of how much pain the patient experienced in past week due to illness as rated by the patient themselves or parent. Measured on scale from no pain (0 mm) to very severe pain (100 mm).|36 months|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 4.5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment.||units on a scale||Standard Deviation|Mean
702234|NCT00069329|Primary|Parent /Patient Pain Rating|Visual analog assessment of how much pain the patient experienced in past week due to illness as rated by the patient themselves or parent. Measured on scale from no pain (0 mm) to very severe pain (100 mm).|Baseline|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg/day per injection were made as frequently as every 2 weeks to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment.||units on a scale||Standard Deviation|Mean
702235|NCT00069329|Primary|Patient / Parent Global Score of Overall Disease Activity|Visual analog assessment of how arthritis affects the patient as rated by the patient themselves or parent. Measured on scale from very well (0 mm) to very poor (100 mm).|60 months|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 20 patients who completed their 5 year assessment.||units on a scale||Standard Deviation|Mean
702236|NCT00069329|Primary|Patient / Parent Global Score of Overall Disease Activity|Visual analog assessment of how arthritis affects the patient as rated by the patient themselves or parent. Measured on scale from very well (0 mm) to very poor (100 mm).|36 months|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 4.5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment.||units on a scale||Standard Deviation|Mean
702237|NCT00069329|Primary|Patient / Parent Global Score of Overall Disease Activity|Visual analog assessment of how arthritis affects the patient as rated by the patient themselves or parent. Measured on scale from very well (0 mm) to very poor (100 mm).|Baseline|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg/day per injection were made as frequently as every 2 weeks to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment.||units on a scale||Standard Deviation|Mean
702238|NCT00069329|Primary|Diary Symptom Sum Score (DSSS) (Fever, Rash, Joint Pain, Vomiting, and Headaches)|"The severity of the main symptoms of the disease were scored on a scale from 0 (no symptoms) to 4 (highest severity) on a daily basis using a diary. Five key symptoms were included in the primary variable DSSS: fever, headache, rash, joint pain, and vomiting. Each of the diary variables was evaluated as a mean value for a period preceding the visits. The baseline value was the mean value of the 5-30 last days before the first dose of Kineret. For the subsequent visits, the mean value of the last 30 days with data before each visit was used as the response variable."|60 months|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 20 patients who completed their 5 year assessment.||units on a scale||Standard Deviation|Mean
702239|NCT00069329|Primary|Diary Symptom Sum Score (DSSS) (Fever, Rash, Joint Pain, Vomiting, and Headaches)|"The severity of the main symptoms of the disease were scored on a scale from 0 (no symptoms) to 4 (highest severity) on a daily basis using a diary. Five key symptoms were included in the primary variable DSSS: fever, headache, rash, joint pain, and vomiting. Each of the diary variables was evaluated as a mean value for a period preceding the visits. The baseline value was the mean value of the 5-30 last days before the first dose of Kineret. For the subsequent visits, the mean value of the last 30 days with data before each visit was used as the response variable."|36 months|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 4.5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment.||units on a scale||Standard Deviation|Mean
702301|NCT00078559|Secondary|Number of Deaths Stratified by Sirolimus Withdrawal Status|Participants who died during the study, all cause(s)|Transplantation to Death (up to four years post-transplant)|Intent-to-treat||deaths|||Number
702240|NCT00069329|Primary|Diary Symptom Sum Score (DSSS) (Fever, Rash, Joint Pain, Vomiting, and Headaches)|"The severity of the main symptoms of the disease were scored on a scale from 0 (no symptoms) to 4 (highest severity) on a daily basis using a diary. Five key symptoms were included in the primary variable DSSS: fever, headache, rash, joint pain, and vomiting. Each of the diary variables was evaluated as a mean value for a period preceding the visits. The baseline value was the mean value of the 5-30 last days before the first dose of Kineret. For the subsequent visits, the mean value of the last 30 days with data before each visit was used as the response variable."|Baseline|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg/day per injection were made as frequently as every 2 weeks to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment.||units on a scale||Standard Deviation|Mean
702241|NCT00075881|Secondary|1-year Progression Free Survival Probability|Progression-free survival is defined as time from randomization to disease progression or death from any cause, whichever occurred first. Disease progression is defined using the ECOG Myeloma Response Criteria. Kaplan-Meier method is used to estimate the 1-year progression-free survival probability. 42 eligible and treated patients were included in the analysis.|Every 3 months if patient is <2 years from study entry, every 6 months if patient is 2-6 years from study entry, no specific requirment if patient is more than 6 years from study entry|42 eligible and treated patients||percentage of participants||95% Confidence Interval|Number
702242|NCT00075881|Secondary|Response Rate on Reinduction|ECOG Myeloma Response Criteria that follows the standard European Group for Blood and Bone Marrow Transplant criteria was used to evaluate patient response and progression. Patients who have complete disappearance of an M-protein and no evidence of myeloma in the bone marrow are considered to have complete response. 7 eligible and treated patients were included in the analysis.|participants were evaluated prior to each cycle, up to 23 cycles with a median number of 3 cycles. 1 cycle=21 days|7 eligible and treated patients were included in the analysis.||percentage of participants||90% Confidence Interval|Number
702243|NCT00075881|Secondary|Response Rate on Maintenance|ECOG Myeloma Response Criteria that follows the standard European Group for Blood and Bone Marrow Transplant criteria was used to evaluate patient response and progression. Patients who have complete disappearance of an M-protein and no evidence of myeloma in the bone marrow are considered to have complete response. 15 eligible and treated patients were included in the analysis.|participants were evaluated prior to each cycle, up to 45 cycles with a median number of 9 cycles. 1 cycle=21 days|15 eligible and treated patients were included in the analysis.||percentage of participants||90% Confidence Interval|Number
702244|NCT00075881|Primary|Response Rate on Induction|Eastern Cooperative Oncology Group (ECOG) Myeloma Response Criteria that follows the standard European Group for Blood and Bone Marrow Transplant criteria was used to evaluate patient response and progression. Patients who have complete disappearance of an M-protein and no evidence of myeloma in the bone marrow are considered to have complete response. 42 eligible and treated patients were included in the analysis.|participants were evaluated prior to each cycle, up to 8 cycles with a median number of 6 cycles. 1 cycle=21 days|42 eligible and treated patients were included in the analysis.||percentage of participants||90% Confidence Interval|Number
702245|NCT00075946|Secondary|Overall Health-related Quality of Life (HRQL) at 6 Month After Randomization|The overall HRQL was measured by the change in Functional Assessment of Cancer Therapy - General (FACT-G) from baseline to 6 months after randomization. The FACT-G is a 27-item assessment used to measure HRQL, specifically, physical, functional, social and emotional well-being. The total score ranges from 0 to 108, with higher scores indicating better HRQL.|Assessed at baseline and 6 months after randomization.|Patients with patient-reported outcomes (PRO) data available.||units on a scale||Standard Deviation|Mean
702246|NCT00075946|Secondary|Time to First Cytotoxic Therapy (TTFC)|TTFC is defined as the time from randomization to the time of first cytotoxic therapy (chemo and radio therapy), and censored as last follow-up time if no cytotoxic therapy has been used. Since median TTFC was not reached in 3 out of the 4 groups, 3-year TTFC was reported which was defined as the probability of not starting first cytotoxic therapy at 3 years.|Assessed every 13 weeks until rituximab failure observed or August 2013, whichever occurred first.|Patients who were correctly randomized to one of the two maintenance arms.||probability||95% Confidence Interval|Number
702247|NCT00075946|Primary|Time to Rituximab Failure (TTRF)|TTRF is defined as the time from randomization until any one of the following criteria are met, and censored at last disease assessment for cases who have not experienced failure (with the cut-off date for final analysis of 11/1/2011): 1. No response (partial response (PR) or complete response (CR)) to rituximab retreatment (Arm A treatment). 2. Time to progression < 26 weeks from day 1 of most recent rituximab treatment. 3. Initiation of alternative therapy. 4. Inability to complete protocol therapy (due to adverse events, patient preference, or any other reason, including death).|Assessed (by restaging CT scans) 26 weeks ± 2 weeks from each rituximab treatment (including induction), counting the first rituximab dose as Day 1, until rituximab failure observed or July 17, 2013, whichever occurred first.|Eligible patients who were randomized to one of the two arms for maintenance therapy.||years||95% Confidence Interval|Median
702248|NCT00076011|Other Pre-specified|Population Pharmacokinetics of Axitinib (AG-013736)|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Day 1 (Pre-dose), Day 29, Day 57 and then every 8 weeks up to 139 weeks||||||
702249|NCT00076011|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms. Change from baseline=Cycle/Day score minus baseline score.|Baseline, Days 29, 57, 113, 169, 225, 281, 337, 393, 449, 505, 561, 617, 673, 729, 785, 841, 897, 953 and follow-up visit after last dose|Study population included all participants who received at least 1 dose of study medication and had a baseline assessment of disease. The 'n' is signifying those participants who were evaluable for this measure at the specified time point.||Units on a scale||Standard Deviation|Mean
702250|NCT00076011|Secondary|Overall Survival (OS)|Time in days from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1). Death was determined from adverse event (AE) data (where outcome was death) or from follow-up contact data (where the participant current status was death). For participants who were alive, overall survival was censored at the last contact.|Baseline to death due to any cause or at least 1 year after the initial dose for the last treated participant|Study population included all participants who received at least 1 dose of study medication.||Days||95% Confidence Interval|Median
702251|NCT00076011|Secondary|Duration of Response (DR)|Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1). DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 139 weeks|Subgroup of participants from the study population with a confirmed objective tumor response (CR or PR).||Days||95% Confidence Interval|Median
702252|NCT00076011|Secondary|Time to Disease Progression (TTP)|Time in days from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever comes first. TTP was calculated as (first event date minus the date of first dose of study medication plus 1). Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]).|Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 139 weeks|Study population included all participants who received at least 1 dose of study medication and had a baseline assessment of disease.||Days||95% Confidence Interval|Median
702253|NCT00076011|Primary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 139 weeks|Study Population included all participants who received at least 1 dose of study medication and had a baseline assessment of disease.||Percentage of participants||95% Confidence Interval|Number
702254|NCT00076024|Other Pre-specified|Population Pharmacokinetics of Axitinib (AG-013736) for Phase 2 (Double-blind)|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Day 1 (pre-dose), Day 22 and Day 43 and then every 9 weeks up to 129 weeks||||||
702255|NCT00076024|Secondary|Duration of Response (DR) for Phase 2 (Open-label)|Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Phase 2 open-label baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 58 weeks|Subgroup of participants from the AT population with a confirmed objective tumor response (CR or PR).||days||95% Confidence Interval|Median
702256|NCT00076024|Secondary|Duration of Response (DR) for Phase 2 (Double-blind)|Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Phase 2 double-blind baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 9 weeks up to 129 weeks|Subgroup of participants from the study population with a confirmed objective tumor response (CR or PR).||days||95% Confidence Interval|Median
702257|NCT00076024|Secondary|Percentage of Participants With Objective Response (OR) for Phase 2 (Open-label)|Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Phase 2 open-label baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 58 weeks|All treated (AT) population included participants from Phase 2 who progressed by RECIST criteria while in the placebo + docetaxel treatment group and had a baseline disease assessment and received at least 1 dose of study medication.||percentage of participants||95% Confidence Interval|Number
702258|NCT00076024|Secondary|Percentage of Participants With Objective Response (OR) for Phase 2 (Double-blind)|Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Phase 2 double- blind baseline until the date of first documented progression or discontinuation from the study treatment due to any cause, assessed every 9 weeks up to 129 weeks|Study population included all randomized participants who had a baseline assessment of disease and the correct histological cancer type.||percentage of participants||95% Confidence Interval|Number
702259|NCT00076024|Primary|Time to Tumor Progression (TTP)|Time in days from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever comes first. TTP was calculated as first event date minus the date of first dose of study medication plus 1. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]).|Phase 2 double-blind baseline until tumor progression or death or discontinuation from study treatment, assessed every 9 weeks up to 129 weeks|Study population included all randomized participants who had a baseline assessment of disease and the correct histological cancer type.||days||95% Confidence Interval|Median
702260|NCT00076050|Secondary|Change in Vaginal Maturation Value|The Vaginal Maturation Value (VMV) describes the proportion of the three vaginal epithelial cell types (parabasal, intermediate and superficial) obtained from a swab of the vaginal walls. The changes in the proportion of each type of cells reflects the degree of exposure to estrogen of the vaginal epithelium. The VMV lists the percentage of each type of cell appearing on the smear, with the total of all three values equaling 100%. The index is read from left to right; i.e. VMI of 5/40/55 represents 5% parabasal cells, 40% intermediate cells and 55% superficial cells. Exposure to estrogens results in some parabasal cells, a greater proportion of intermediate cells and few superficial cells.|baseline and 2 years|||score||Standard Error|Mean
702261|NCT00076050|Secondary|Changes in Women's Health Questionnaire Score|This self-administered questionnaire contains 23 items, distributed among 6 factors: anxiety and depressed mood (7 items), well-being (4 items), somatic symptoms (5 items), memory and concentration (3 items), vasomotor symptoms (2 items) and sleep problems (2 items). The instrument has a structured format and the response choices consist of 4-point Likert scales (‘yes definitely’ to ‘no, not at all’). Item scores are collapsed into a dichotomous scale, where higher scores indicate a greater level of symptomatology or difficulty; i.e., if the response is 1 or 2 (positive response), the score = 1; if the response is 3 or 4 (negative response), the score is 0. Results can be reported as a total score, where the range is 0-23, but also for each dimension. Thus, the ranges of the subscales are: for anxiety and mood 0-7, for well-being 0-4, somatic symptoms 0-5, memory and concentration 0-3, vasomotor symptoms 0-2 and sleep problems 0-2.|baseline and 2 years|||change in score||Standard Error|Mean
702262|NCT00076050|Primary|Change From Baseline in Bone Mineral Density||baseline and 2 years|||g/cm2||Standard Deviation|Mean
702263|NCT00076102|Primary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|5 years|||Participants|||Number
702264|NCT00076102|Primary|Median Time to Disease Progression|Time to progression is defined as greater than or equal to 20% increase in plexiform neurofibromas (PN) volume on magnetic resonance imaging (MRI).|5 years|||Months||95% Confidence Interval|Median
702265|NCT00076219|Primary|60-day All-cause Mortality|60-day all-cause mortality|60 days|Number of all-cause mortality by day 60||participants|||Number
702266|NCT00076245|Primary|Remission Status on Structured Interview Guide for the Hamilton Depression Rating Scale—Seasonal Affective Disorder Version (SIGH-SAD)|Dichotomous Remission Status (remitted or not) at post-treatment|Post-treatment|||participants|||Number
702267|NCT00076245|Primary|Scores on the Structured Interview Guide for the Hamilton Depression Rating Scale—Seasonal Affective Disorder Version|The Structured Interview Guide for the Hamilton Depression Rating Scale—Seasonal Affective Disorder Version (SIGH-SAD) measures depressive symptoms on a continuous scale. Higher scores indicate worse outcome. Range of scores is 0 to 73. Generally, a score of 20 or higher is the cutoff for clinical depression.|Post-treatment|||units on a scale||Standard Deviation|Mean
702268|NCT00078286|Secondary|Percentage of Cardiac Events and Morbidity / Mortality, Including Rehospitalization, in Congestive Heart Failure Patients With Depression After Treatment With Sertraline or Placebo.|Composite cardiovascular scores are calculated for each participant using recorded cardiac events, morbidity/mortality, rehospitalization, and discontinuation due to cardiovascular events. Composite score is compared for sertraline and placebo treatment groups.|Measured at Week 12|Analysis was based on intent to treat (ITT).||percentage of participants|||Number
702269|NCT00078286|Primary|Symptoms of Depression in Congestive Heart Failure Patients With Clinical Depression After Treatment With Sertraline or Placebo|"Symptoms of depression (as measured by the Hamilton Depression Rating Scale, HDRS) in congestive heart failure patients with clinical depression after treatment with sertraline or placebo.
The 17-item Hamilton Depression Rating Scale (HDRS) is a rater-administered assessment of depression severity, with total score ranges from 0 (not at all depressed) to 52 (most severely depressed). Change in depression was measured as the difference between the 12-week HDRS scores and the baseline HDRS scores. Thus, a negative value reflects an improvement in depressive symptoms over the 12-week period."|Measured at Week 12|Analysis was based on intent to treat (ITT), using random coefficient modeling.||HDRS Change Score||Standard Deviation|Mean
702270|NCT00078312|Primary|Safety and Tolerability as Measured by Number of Participants With Adverse Events|Serious and Non-serious Adverse Events (SAEs). Serious adverse event is any adverse event occurring at any dose that results in any of the following outcomes: death, life-threatening, inpatient hospitalization, persistent or significant disability, congenital anomaly, or an important medical event. An adverse event that does not meet any of the criteria for seriousness listed previously will be regarded as a nonserious adverse event.|Screening/Baseline and months 1, 3, 6, 9, and 12 and every 3 months thereafter|Safety Analysis set of 323 total patients: 5 participants withdrew after enrollment but prior to receiving study drug (1 withdrew consent, 3 were lost to follow-up, and 1 was noncompliant)||Participants|||Number
702271|NCT00078325|Primary|Clinical Global Impression of Change (CGI-C)|The CGI-C represents a subjective measure of the patient’s global health (clinician’s rating of disease severity as compared with a pretreatment evaluation as assessed by the CGI-S). The CGI-C scale (change from baseline)categories include:1=Very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; and 7=Very much worse. Severity of illness (CGI-S) was assessed at baseline includes categories: 1=Normal; 2=Borderline ill; 3=Mildly (Slightly) ill; 4=Moderately ill; 5=Markedly ill; 6=Severely ill; and 7=Among the most extremely ill patients.|change from baseline at 12 weeks|Safety Analysis set of 392 total patients (ITT): 3 patients withdrew after randomization but prior to receiving study drug (1 had a protocol violation and 2 were lost to follow-up)||Participants|||Number
703675|NCT00095498|Secondary|Change From Baseline in Eosinophils at Month 1|Laboratory hematology eosinophils|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.||* 10^9/L||Standard Deviation|Mean
702272|NCT00078325|Primary|Maintenance of Wakefulness Test (MWT)|The MWT is an objective assessment of sleepiness that measures the ability of a subject to remain awake. Long latencies to sleep are indicative of a patient’s ability to remain awake. The primary variable was the 30 minute MWT (average of 4 naps at 0900, 1100, 1300, and 1500) assessed at the last postbaseline observation.|change from baseline at 12 weeks|"Safety Analysis set of 392 total patients: 3 patients withdrew after randomization but prior to receiving study drug (1 had a protocol violation and 2 were lost to follow-up)
Full Analysis set of 365 total patients: 27 patients that had withdrawn from the study were non-evaluable for efficacy."||Minutes||Standard Deviation|Mean
702273|NCT00078377|Primary|Change From Baseline in Clinical Global Impression of Change (CGI-C) Score at 12 Weeks|Number of participants who had at least minimal improvement in CGI-C ratings at Week 12 or last post-baseline visit. The CGI-C uses the following categories and scoring assignments: 1=Very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; and 7=Very much worse. Severity of illness was assessed at baseline by the CGI-S, which consists of the following categories: 1=Normal (shows no signs of illness); 2=Borderline ill; 3=Mildly (Slightly) ill; 4=Moderately ill; 5=Markedly ill; 6=Severely ill; and 7=Among the most extremely ill patients.|change from baseline at 12 weeks|"Safety Analysis set of 194 total patients (received at least 1 dose of study drug): 2 patients withdrew after randomization but prior to receiving study drug (1 withdrew consent and 1 was lost to follow-up).
Full Analysis set of 176 total patients: 18 patients that had withdrawn from the study were non-evaluable for efficacy analysis."||Participants|||Number
702274|NCT00078377|Primary|Change From Baseline in Maintenance of Wakefullness Test (MWT) Score at 12 Weeks|The Maintenance of Wakefulness Test (MWT) is an objective assessment of sleepiness that measures the ability of a subject to remain awake. Long latencies to sleep are indicative of a patient’s ability to remain awake. The change from baseline in the mean sleep latency from the MWT (average of 4 tests at 0900, 1100, 1300, and 1500) was analyzed at weeks 4, 8, and 12. The primary efficacy variable was the mean change from the baseline assessment in MWT sleep latency as assessed at week 12 (or last post-baseline visit).|change from baseline at 12 weeks|"Safety Analysis set of 194 total patients: 2 patients withdrew after randomization but prior to receiving study drug (1 withdrew consent and 1 was lost to follow-up).
Full Analysis set of 176 total patients: 18 patients that had withdrawn from the study were non-evaluable for efficacy."||Minutes||Standard Deviation|Mean
702275|NCT00078403|Secondary|Weight|Participant weight in kilograms.|Arms A and B: at entry and weeks 4, 8, 12, 16, 24, 32, 40, 48, 56, 64 and 72; Arm C: at entry and weeks 4, 8, 12, 16, 24, 36, 48, 72, 84 and 96.|All Arm A, B and C participants who had weight available. The number of participants with results available at time points listed in the Time Frame are shown in the Data Table Row Titles below.||kilograms||Inter-Quartile Range|Median
702276|NCT00078403|Secondary|Number of Participants With Prescription as Needed of Erythropoietin (EPO), Granulocyte Colony-stimulating Factor (GCSF), and Granulocyte-monocyte Colony-stimulating Factor (GM-CSF)|Prescription as needed of hematologic adjuvant therapies: erythropoietin (EPO), granulocyte colony-stimulating factor (GCSF), and granulocyte-monocyte colony-stimulating factor (GM-CSF) any time after pre-assignment|At any time after pre-assignment|All Arm A, B and C participants||Participant|||Number
702277|NCT00078403|Secondary|Number of Participants Who Used Antianorexia Agents, Such as Megestrol and Dronabinol|Use of antianorexia agents, such as megestrol and dronabinol at any time after pre-assignment.|Up to 96 weeks|All Arm A, B and C participants||Participant|||Number
702278|NCT00078403|Secondary|Sustained Virologic Response|Sustained Virologic Response (SVR) was defined as undetectable HCV viral load (<60 IU/ml) 24 weeks after treatment discontinuation.|24 weeks after end of treatment|All Arm A, B and C participants||Participant|||Number
702279|NCT00078403|Secondary|Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)|Insulin resistance was evaluated by HOMA-IR, calculated as [fasting glucose (mg/dL) x fasting insulin (uIU/mL)]/405. Study protocol required fasting for at least 8 hours (nothing by mouth except medications and water) prior to specimen collection for fasting insulin and fasting glucose testing.|Arms A and B: at entry and weeks 24, 48 and 72; Arm C: at entry and at weeks 12, 24, 36, 48, 72, 84 and 96.|All Arm A, B and C participants who had HOMA-IR result available. In Arm C, metabolic testing was only performed on participants who enrolled under protocol version 1.0. The number of participants with results available at time points listed in the Time Frame are shown in the Data Table Row Titles below.||mg/dL x uIU/mL||Inter-Quartile Range|Median
702280|NCT00078403|Secondary|Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL)|A blood sample was drawn to determine the HIV-1 viral load. HIV-1 viral load was categorized as <50 copies/mL (undetectable) or >=50 copies/mL (detectable). 50 is the lower limit of detection of the assay.|Arms A and B: Weeks 0, 24, 48 and 72; Arm C: Weeks 0, 12, 24, 36, 48, 60, 72, 84|All Arm A, B, and C participants||Participant|||Number
702281|NCT00078403|Secondary|HCV-specific Immune Response in Intrahepatic Lymphocytes|Due to premature closure of Arms A and B with insufficient number of participants for analysis, this outcome measure was not pursued.|Entry and week 72 (Arms A and B only).|Due to premature closure of Arms A and B with insufficient number of participants for analysis, this outcome measure was not pursued. No participants were analyzed.|||||
702282|NCT00078403|Secondary|HCV Polymorphisms|Due to premature closure of Arms A and B with insufficient number of participants for analysis, this outcome measure was not pursued.|Entry and week 72 (Arms A and B only).|Due to premature closure of Arms A and B with insufficient number of participants for analysis, this outcome measure was not pursued. No participants were analyzed.|||||
702283|NCT00078403|Secondary|Number of Participants Adherent to Study Medications|A categorical variable with levels adherent and non-adherent based on participants' self report. For Arm A, adherence was defined as not missing PEG within 2 weeks of visit. For Arm C, adherence was defined as not missing any PEG within 2 weeks of visit and not missing RBV within 4 days of visit.|Arm A: at weeks 12, 24, 48 and 72. Arm C: at entry and weeks 12, 24, 48, 60.|All Arm A and Arm C participants. Arm B participants did not receive treatment.||Participant|||Number
702284|NCT00078403|Secondary|Number of Participants With Dose Modifications, Temporary Stops, and Premature Treatment Discontinuations|3-level categorical of the worst of 1) premature treatment discontinuation, 2) temporary stop or 3) dose reduction. For Arm C, the worst for either PEG-IFN or RBV is summarized.|Up to 96 Weeks|All Arm A and C participants. Arm B participants did not receive treatment.||Participant|||Number
728438|NCT00380250|Secondary|Month 3 Bowel Straining Change From Baseline|0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|Change from baseline for month 3|||Scale score||Standard Deviation|Mean
702285|NCT00078403|Secondary|Number of Participants With High-grade Signs and Symptoms or Laboratory Values|Number of participants with high-grade (Grade 3 or higher) signs and symptoms or laboratory values. DAIDS Toxicity Grading Table (1992) was used for grading where Grade 1 = transient/mild discomfort, no limitation in activity, no medical intervention; Grade 2 = mild/moderate limitation in activity, some assistance, no/minimal medical intervention; Grade 3 = marked limitation in activity, some assistance, medical intervention required); Grade 4 = extreme limitation in activity, significant medical intervention, assistance, hospitalization.|Up to 96 Weeks|All Arm A, B and C participants||Participant|||Number
702286|NCT00078403|Secondary|Number of Participants With Depression and/or Other Psychological Events|Depression and other psychological events. DAIDS Toxicity Grading Table (1992) was used for grading. The protocol required reporting of depression and other psychological events of Grade 3 or higher or if led to a change in treatment, regardless of grade.|Up to 96 weeks|All Arm A, B and C participants||Participant|||Number
702287|NCT00078403|Secondary|Number of Participants With Thrombocytopenia|Number of participants with thrombocytopenia by grade (defined by platelet count per cubic millimeter; mm^3). DAIDS Toxicity Grading Table (1992) was used for grading where Grade 1 = platelets of 75,000 to 99,000 /mm^3; Grade 2 = 50,000 to 74,999 /mm^3; Grade 3 = 20,000 to 49,999 /mm^3; Grade 4 = below 20,000 /mm^3.|Up to 96 weeks|All Arm A, B and C participants||Participant|||Number
702288|NCT00078403|Secondary|Number of Participants With Neutropenia|Number of participants with neutropenia by grade (defined by absolute neutrophil count [ANC] per cubic millimeter; mm^3). DAIDS Toxicity Grading Table (1992) was used for grading where Grade 1 = ANC of 1000 to 1500 /mm^3; Grade 2 = 750 to 999 /mm^3; Grade 3 = 500 to 749 /mm^3; Grade 4 = below 500 /mm^3.|Up to 96 weeks|All Arm A, B and C participants||Participant|||Number
702289|NCT00078403|Secondary|Number of Participants With Anemia|Number of participants with anemia by grade (defined by hemoglobin level in grams per deciliter; g/dL). DAIDS Toxicity Grading Table (1992) was used for grading where Grade 1 = hemoglobin of 8 to 9.4 g/dl; Grade 2 = 7 to 7.9 g/dl; Grade 3 = 6.5 to 6.9 g/dl; Grade 4 = below 6.5 g/dl.|Up to 96 weeks|All Arm A, B and C participants||Participant|||Number
702290|NCT00078403|Secondary|Time-scaled Change in Ishak Liver Inflammation Score (SCIIS)|Liver biopsies were performed within 42 days prior to randomization between Arms A and B while the participant remained on PEG-IFN plus RBV (=entry biopsy) and again at week 72 or premature study discontinuation (=exit biopsy). SCIIS was defined as the difference between the Ishak inflammation score of the exit biopsy and the Ishak inflammation score of the entry biopsy, where the difference is scaled to one year.|Baseline and at week 72 or premature discontinuation|All participants with SCIIS available (Complete Cases)||Ishak units per one year (52 weeks)||Inter-Quartile Range|Median
702291|NCT00078403|Secondary|Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL)|Qualitative plasma HCV viral load was categorized as less than 60 IU/mL vs greater than or equal to 60 IU/mL where 60 IU/mL is the lower limit of qualitative assay used in Steps 2 and 3.|Arms A and B: Weeks 0, 12, 24, 48 and 72; Arm C: Weeks 0, 12, 24, 36, 60, 72, 84|All Arm A, B and C participants||Participant|||Number
702292|NCT00078403|Primary|Time-scaled Change in Metavir Liver Fibrosis Score (SCMFS)|SCMFS is the difference between the Metavir fibrosis scores of the study exit and study entry liver biopsies where the difference is scaled to one year. The SCMFS assesses the annualized change in the severity of liver fibrosis on a continuous scale from -4.0 Metavir units per year (reduced fibrosis over time, a positive study outcome) to +4.0 Metavir units per year (increased fibrosis over time).|Baseline and at week 72 or premature discontinuation|62 Arm A and B participants who had follow-up liver biopsy performed or those who had Week 72 potential as of May 2, 2007 but no follow-up liver biopsy. In the unadjusted ITT analysis, the participants without SCMFS available were assigned the highest SCMFS (+2).||Metavir units per one year (52 weeks)||Inter-Quartile Range|Median
702293|NCT00078559|Secondary|Change in Renal Function as Measured by Serum Creatinine, Stratified by Withdrawal Status|Mean change from transplantation to Month 48 in serum creatinine. Normal serum creatinine range is from 0.7 – 1.4 mg/dL. In a transplant population, starting serum creatinine is higher than normal range. A negative change indicates better renal function|Transplantation to end of study (up to four years post-transplant)|Intent-to-treat||mg/dL||Standard Deviation|Mean
702294|NCT00078559|Secondary|Number of Side Effects of Conventional Immunosuppression, Stratified by Withdrawal Status|Side effects of conventional immunosuppression include increased body weight and hypertension|Transplantation to end of study (up to four years post-transplant)|Intent-to-treat||side effects|||Number
702295|NCT00078559|Secondary|Number of Sirolimus Associated Adverse Events, Stratified by Sirolimus Withdrawal Status||Transplantation to end of study (up to four years post-transplant)|Intent-to-treat||adverse events|||Number
702296|NCT00078559|Secondary|Number of Tacrolimus Associated Adverse Events, Stratified by Sirolimus Withdrawal Status||Transplantation to end of study (up to four years post-transplant)|Intent-to-treat||adverse events|||Number
702297|NCT00078559|Secondary|Number of Alemtuzumab Associated Adverse Events, Stratified by Sirolimus Withdrawal Status||Transplantation to end of study (up to four years post-transplant)|Intent-to-treat||adverse events|||Number
702298|NCT00078559|Secondary|Number of Participants Requiring Anti-lymphocyte Therapy for an Acute Rejection, Stratified by Sirolimus Withdrawal Status|"Participants who experienced acute rejection[1] during study which required anti-lymphocyte (OKT3, ATG) therapy
1] Acute rejection is defined as a biopsy-prove rejection: a renal biopsy demonstrates acute cellular or humoral rejection of Banff[2] Grade 1B or greater; or presumed rejection in the absence of biopsy-proven rejection, the participant is treated for an unexplained 20% increase in serum creatinine.
[2] Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999"|Transplantation to acute rejection (up to four years post-transplantation)|Intent-to-treat||participants|||Number
702299|NCT00078559|Secondary|Number of Severe Acute Rejections Stratified by Sirolimus Withdrawal Status|"Participants who experienced severe acute rejections[1] during study
Severe acute rejection is defined as that which requires treatment with anti-lymphocyte antibody or is histologically evaluated as Type IIA or greater using the Banff 1997 criteria[2]
Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999"|Transplantation to severe acute rejection (up to four years post-transplantation)|Intent-to-treat||Rejection Events|||Number
707353|NCT00122369|Primary|Pain Ratings at Specified Time Point During the Procedure|Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain|70 min|Patients remaining on procedure table||units on a scale||Inter-Quartile Range|Median
702302|NCT00078559|Secondary|Time From Transplantation to Acute Rejection in Participants for Whom Acute Rejection Occurred During the 1 Year Post-transplant Period|"Time (days) to acute rejection[1] for participants occurring during the year following transplantation
1] Acute rejection is defined as a biopsy-proven rejection: a renal biopsy demonstrates acute cellular or humoral rejection of Banff[2] Grade 1B or greater; or presumed rejection in the absence of biopsy-proven rejection, the participant is treated for an unexplained 20% increase in serum creatinine.
[2] Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999"|Transplantation to acute rejection (up to one year post-transplant)|Participants with acute rejections for whom sirolimus withdrawal was not initiated||Days|||Number
702303|NCT00078559|Secondary|Time From Transplantation to Acute Rejection in Participants for Whom Sirolimus Withdrawal Was Not Initiated|"Time (days) to acute rejection[1] for participants where sirolimus was not initiated
1] Acute rejection is defined as a biopsy-proven rejection: a renal biopsy demonstrates acute cellular or humoral rejection of Banff[2] Grade 1B or greater; or presumed rejection in the absence of biopsy-proven rejection, the participant is treated for an unexplained 20% increase in serum creatinine.
[2] Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999"|Transplantation to acute rejection (up to four years post-transplantation)|Participants for whom sirolimus withdrawal was not initiated||Days|||Number
702304|NCT00078559|Secondary|Number of Acute Rejections Between Initiation of Sirolimus Withdrawal and End of Study|"Acute rejections[1] between initiation of sirolimus withdrawal and end of study
1] Acute rejection is defined as a biopsy-proven rejection: a renal biopsy demonstrates acute cellular or humoral rejection of Banff[2] Grade 1B or greater; or presumed rejection in the absence of biopsy-proven rejection, the participant is treated for an unexplained 20% increase in serum creatinine.
[2] Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999"|Initiation of sirolimus to end of study (up to four years post-transplant)|Sirolimus withdrawal initiation participant sample||Rejection Events|||Number
702305|NCT00078559|Secondary|Number of Acute Rejections in All Enrolled Participants Following Sirolimus Withdrawal|"Following sirolimus withdrawal, the number of acute rejections[1] in all enrolled participants
1] Acute rejection is defined as a biopsy-proven rejection: a renal biopsy demonstrates acute cellular or humoral rejection of Banff[2] Grade 1B or greater; or presumed rejection in the absence of biopsy-proven rejection, the participant is treated for an unexplained 20% increase in serum creatinine.
[2] Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999"|Transplantation to end of study (up to four years post-transplant)|Intent-to-treat||Rejection Events|||Number
702306|NCT00078559|Primary|Number of Acute Rejections in All Enrolled Participants|"Number of acute rejections[1] in all enrolled subjects from the time of transplantation to the end of the trial (four years post-transplant)
Acute rejection is defined as a biopsy-proven rejection: a renal biopsy demonstrates acute cellular or humoral rejection of Banff[2] Grade 1B or greater; or presumed rejection in the absence of biopsy-proven rejection, the participant is treated for an unexplained 20% increase in serum creatinine.
Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999"|Four years post-transplant|Intent-to-treat||Rejection Events|||Number
702307|NCT00078715|Secondary|To Determine Whether Measures Previously Demonstrated to be Predictive of Response to Sleep Deprivation & Noradrenergically Mediated Will be Assoc With Response to Yohimbine When Administered During REM Sleep.||2-4 weeks||||||
702308|NCT00078715|Primary|Hamilton Depression Rating Scale (6 Items)|The 6 item Hamilton Depression Rating Scale is a measurement of the severity of depression with a range of scores from 0 to 24, where 24 indicates the most severe depression.|Once per day, where the primary comparison involves an average over the full study after controlling for baseline|||Units on a scale||Standard Error|Mean
702309|NCT00078728|Primary|Child Anxiety Diagnoses|The cumulative number of children who developed an anxiety disorder at each assessment point during the study. Using the intent to treat sample, a total of 6 children in the non-intervention group developed an anxiety disorder by the 12-month assessment. No children in the CAPS group developed an anxiety disorder.|12 months|||participants|||Number
702310|NCT00078728|Primary|Child Anxiety Diagnosis|Measured by the Anxiety Disorder Interview Schedule for the Diagnostic and Statistical Manual of Mental Disorders 4th edition, child and parent versions.|12 month||01/2009||||
702311|NCT00078754|Secondary|Treatment Response, Assessed as a Function of the Severity of Lifetime Aggressiveness of the Participant and as a Function of the Pretreatment Status of the Central 5-HT Receptor System||Measured at Week 12||||||
702312|NCT00078754|Primary|Overt Aggression Scale-Modified (OAS-M)|OAS-M is a validated instrument that measures aggression. Anti-aggressive effect of the drug/placebo was measured by the aggression score from OAS-M. Possible scores for aggression range from 0 (no aggression) to infinity (because the score is calculated by the number of times an aggressive behavior occurred, which theoretically has no possible maximum). Therefore the bigger number, the worse anti-aggression effect, thus the worse outcome. In each weekly visit, OAS-M score was calculated for the past week.|Measured at Week 12|||units on a scale||Standard Error|Mean
702313|NCT00078767|Secondary|Incidence of Suicidality|Change in degree of suicidal ideation during study|Up to 39 months|||Participants|||Count of Participants
702314|NCT00078767|Secondary|Global Impairment|Change in Children's Global Assessment Scale (CGAS) between the two groups|Up to 39 months|There were two categories of depression: participants that had clinical signs of impairment at the time of enrollment as evidenced by their CGAS scores, and participants that did not have clinical signs of depression. Participants clinical symptoms were tested to see if their status changed during the trial.||Participants|||Count of Participants
702315|NCT00078767|Secondary|Anxiety Symptoms|"Change in SCARED scores between treatment groups.There were two categories of depression: participants that had clinical signs of depression at the time of enrollment, and participants that did not have clinical signs of depression. Participants in the clinical symptom present at enrollment category were tested to see if their status changed during the trial."|Up to 39 months|There were two categories of anxiety symptoms: participants that had clinical signs of anxiety at the time of enrollment as evidenced by their SCARED scores, and participants that did not have clinical signs of depression. Participants with clinical symptoms category were tested to see if their status changed during the trial.||Participants|||Count of Participants
702316|NCT00078767|Secondary|Mood and Feelings Questionnaire (MFQ) for Depressive Symptoms|Change in depressive symptoms as determined by change in score|Up to 39 months|"There were two categories of depression: participants that had clinical signs of depression at the time of enrollment, and participants that did not have clinical signs of depression. Participants in the clinical symptom present at enrollment category were tested to see if their status changed during the trial."||Participants|||Count of Participants
702317|NCT00078767|Primary|Kiddie-Sads-Present and Lifetime (KSADS-PL) Scale for PTSD|Change in PTSD parameters as determined by changes in score. At enrollment, participants either did or did not have a PTSD diagnosis. The three categories displayed show participants who had the PTSD diagnosis at the time of enrollment but did have evidence of PTSD at the end of their participation, participants who had PTSD at enrollment and who continued to exhibit PTSD at the end of their participation, and those who did not have a PTSD diagnosis at the start of the trial. There are numerous criteria used to determine a PTSD diagnosis; they are not individually listed. The diagnosis was sufficient for the purposes of the study.|Up to 39 months|||Participants|||Count of Participants
702318|NCT00078949|Secondary|Toxicity Assessed by NCI CTC v2.0 for 2 Years in Patients on Treatment Arm II||10 years||||||
702319|NCT00078949|Secondary|Mobilization Rate of Patients on Treatment Arm I Assessed by CD34 Count After 2 Courses of Therapy and Stem Cell Harvesting||10 years||||||
702320|NCT00078949|Primary|Event-free Survival of Patients on Maintenance Randomization (Period 2)|Number of patients who develop EFS event during maintenance randomization (period 2)|during the period 2 (up to10 years)|ITT population||participants|||Number
702321|NCT00078949|Primary|Transplantation Rate of Patients After 2 Courses of Chemotherapy|Transplantation rate is defined as the number of patients who respond sufficiently to protocol salvage chemotherapy to be planned for transplantation minus those who do not meet the endpoint of successful transplantation, divided by the number of all randomized patients|During period 1 (salvage chemotherapy)|||percentage of transplantation|||Number
702322|NCT00078949|Primary|Response Rate of Patients After 2 Courses of Chemotherapy|The overall response rate by arm is calculated as total number of responders (CR + CRu + PR) / (all patients in the ITT analysis population).|After 2 cycle of treatment|ITT population||percentage of response|||Number
702323|NCT00079001|Secondary|Progression-free Survival|"Progression Free Survival (PFS) was defined as the time from registration until disease progression or death, whichever occurs first. The median PFS with 95% CI was estimated using the Kaplan-Meier method.
Progression is defined as one or more of the following: new bone metastases, biochemical progression of PSA, treatment with radiation therapy while on treatment."|Up to 10 years|||months||95% Confidence Interval|Median
702324|NCT00079001|Secondary|Overall Survival|Overall survival (OS) was defined as the time from randomization to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% CI was estimated using the Kaplan Meier method.|Up to 10 years|||months||95% Confidence Interval|Median
702325|NCT00079001|Primary|Time to First Skeletal Related Event|Time to first skeletal related event (SRE) was defined as the time from randomization to first skeletal event. Skeletal events are defined as radiation to bone, clinical fracture, surgery to bone and spinal cord compression and death due to prostate cancer. The median with 95% CI was estimated using the Kaplan Meier method.|Up to 10 years|||months||95% Confidence Interval|Median
702326|NCT00079040|Secondary|Best Objective Response|Number of patients with complete or partial response by RECIST criteria.|Assessed every 6 weeks|Per protocol, the analysis included all eligible, treated patients.||Patients Responding|||Number
702327|NCT00079040|Secondary|Overall Survival|Overall survival is defined as the time from registration to death or date last known alive. Patients alive at last follow-up are censored.|Assessed every 3 months for 2 years, then every 6 months for 1 year|Per protocol, the analysis included all eligible, treated patients||months||95% Confidence Interval|Median
702328|NCT00079040|Primary|Percentage of Participants Alive and Progression-free (PF) at 6 Months|Progression-free survival was defined to be the interval in months from the date of registration to the date of documented disease progression or to death without progression. Patients alive without progression at 6 months were included in the numerator when calculating the progression-free rate.|6 months|Per protocol, the analysis included all eligible, treated patients (n=63). The safety analysis included all treated patients, regardless of eligibility (n=64).||Percentage of Participants||95% Confidence Interval|Mean
702329|NCT00079183|Secondary|Probability of Cumulative Incidence of Recurrent Malignancy|Analyzed with death as a competing risk factor. Assessed at 7 years.|Approximately 7 years|||probability||95% Confidence Interval|Number
702330|NCT00079183|Secondary|Probability of Cumulative Incidence of Death Without Recurrent Malignancy|Analyzed with recurrent malignancy as a competing risk factor. Assessed at 7 years.|Approximately 7 years|||probability||95% Confidence Interval|Number
702331|NCT00079183|Secondary|Probability of Overall Survival|Kaplan-Meier estimate assessed at 7 years|Approximately 7 years|||survival probability||95% Confidence Interval|Number
702332|NCT00079183|Secondary|Probability of Survival Without Recurrent Malignancy|Kaplan-Meier estimate assessed at 7 years for probability of survival without recurrent malignancy.|Approximately 7 years|||disease free survival probability||95% Confidence Interval|Number
702333|NCT00079183|Secondary|Duration of Treatment With Prednisone||Approximately 7 years|||Months||Full Range|Mean
702334|NCT00079183|Secondary|Secondary Malignancies|Proportion of participants who developed at least one secondary malignancy by 7 years|Up to 7 years|||Participants|||Count of Participants
702335|NCT00079183|Secondary|Proportion With Infections Categorized by Organism||Approximately 7 years|||Participants|||Count of Participants
702336|NCT00079183|Secondary|Proportion of Patients Who Discontinue Administration of Sirolimus Because of Toxicity||Approximately 7 years|||Participants|||Count of Participants
702337|NCT00079183|Primary|Number of Participants With Recurrent Malignancy|Defined as clinical or histopathologic evidence demonstrating the presence of any malignancy considered as the indication for transplant. Recurrent malignancy will also be defined as any post-transplant intervention not routinely used to prevent the development of overt recurrence, prompted by laboratory evidence of persisting malignant cells but without clinical or histopathologic evidence of recurrence.|Approximately 7 years|||Participants|||Count of Participants
707354|NCT00122369|Primary|Pain Ratings at Specified Time Point During the Procedure|Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain|60 min|Patients remaining on procedure table||units on a scale||Inter-Quartile Range|Median
702338|NCT00079183|Primary|Number of Participants Needing Additional Systemic Therapy|Includes any intervention intended to control chronic GVHD through an immunosuppressive effect from oral or parenteral administration of any systemic medication not originally given under auspices of this protocol.|Approximately 7 years|||Participants|||Count of Participants
702339|NCT00079183|Primary|Number of Participants Experiencing Treatment Failure|Defined as the initiation of additional systemic therapy, development of bronchiolitis obliterans, or death from causes other than recurrent malignancy during primary treatment for chronic GVHD, whichever occurs first.|Approximately 7 years|||Participants|||Count of Participants
702340|NCT00079183|Primary|Number of Participants Experiencing Treatment Success|Defined as the absence of any immunosuppressive treatment, including sirolimus, with resolution of all reversible manifestations of chronic GVHD and no additional systemic therapy.|Approximately 7 years|||Participants|||Count of Participants
702341|NCT00079274|Secondary|Toxicity|Number of grade 3+, grade 4, and grade 5 adverse events. Based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0|Assessed up to 8 years||||||
702342|NCT00079274|Secondary|Overall Survival|The time from randomization until death. Estimated by the method of Kaplan and Meier.|Up to 8 years||01/2018||||
702343|NCT00079274|Secondary|Disease-free Survival|The time from randomization until tumor recurrence or death, whichever is first. Estimated by the method of Kaplan and Meier.|Up to 5 years||||||
702344|NCT00079274|Secondary|Disease-free Survival (Arms A and D: Mutant KRAS Patients)|"A secondary endpoint for this study was to investigate the disease-free survival (DFS) in patients with stage III colon cancer who are KRAS mutant (or KRAS-nonevaluable) and randomized to one of two treatment regimens: 1) oxaliplatin, leucovorin calcium, and fluorouracil (Arm A) or 2) oxaliplatin, leucovorin calcium, fluorouracil and cetuximab (Arm D). Participants treated according to Arms B, C, E, and F treatment schedules received treatment which included irinotecan hydrochloride and therefore were not analyzed for this endpoint.
Disease-free survival is defined as the time from randomization until tumor recurrence or death, whichever is first. Estimated by the method of Kaplan and Meier."|At 3 years|The analysis was performed using intention to treat principles. All patients that were KRAS mutant (or not evaluable for KRAS) and received randomized treatment according to the Arm A or Arm D intervention schedule were evaluated for this endpoint. Any patient receiving irinotecan was not included in the evaluation of this endpoint.||percentage of participants||95% Confidence Interval|Number
702345|NCT00079274|Primary|Disease-free Survival (Arms A and D: Wild-type KRAS Patients)|"The primary endpoint for this study was to compare the disease-free survival (DFS) in patients with stage III colon cancer who are KRAS wild-type randomized to one of two treatment regimens: 1) oxaliplatin, leucovorin calcium, and fluorouracil (Arm A) or 2) oxaliplatin, leucovorin calcium, fluorouracil and cetuximab (Arm D). Participants treated according to Arms B, C, E, and F treatment schedules received treatment which included irinotecan hydrochloride and therefore were not analyzed for this endpoint.
Disease-free survival is defined as the time from randomization until tumor recurrence or death, whichever is first. Estimated by the method of Kaplan and Meier."|At 3 years|The analysis was performed using intention to treat principles. All patients that were wild-type KRAS and received randomized treatment according to the Arm A or Arm D intervention schedule were evaluated for this endpoint. Any patient receiving irinotecan was not included in the evaluation of this endpoint.||percentage of participants||95% Confidence Interval|Number
702346|NCT00079326|Secondary|Time to Treatment Failure (TTF)|Time to Treatment Failure as determined by RECIST v.1.0 Criteria: is the time from the date of randomization or start of treatment to the earliest date of progression, date of death due to any cause, or date of discontinuation due to reasons of adverse events, abnormal laboratory values, abnormal test procedure results, subject withdraws consent, or date 'Lost to follow up'.|up to 6 years|||months||95% Confidence Interval|Median
702347|NCT00079326|Primary|Overall Response Rate|Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by computed tomography or magnetic resonance imaging scans: Complete response (CR) is defined as the disappearance of all target lesions; Partial Response is defined by at least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response Rate (ORR) = CR + PR.|Up to 6 years|||percentage of participants||95% Confidence Interval|Number
702348|NCT00079339|Secondary|Mean Tumor to White Matter Ratio Measured at Baseline|This study attempts to characterize neuroimaging parameters from positron emission tomography. For each patient, the axial image through the tumor containing the maximum activity per pixel corresponding to the highest FluoroDeoxyGlucose (FDG) uptake was identified and a region of interest (ROI) was drawn based on the FDG definition of the tumor. The mean pixel values within the tumor ROI were normalized by those for normal white matter to provide ratios of tumor/white matter. Each patient has a mean tumor to white matter ratio value and the median of these values across patients is reported.|Baseline|The analysis population consists of participants, from both the phase I part and the phase II part, treated at any dose level who had a baseline PET scan.||Ratio||Full Range|Median
702349|NCT00079339|Secondary|Mean Tumor to Gray Matter Ratio Measured at Baseline|This study attempts to characterize neuroimaging parameters from positron emission tomography. For each patient, the axial image through the tumor containing the maximum activity per pixel corresponding to the highest FluoroDeoxyGlucose (FDG) uptake was identified and a region of interest (ROI) was drawn based on the FDG definition of the tumor. The mean pixel values within the tumor ROI were normalized by those for normal gray matter to provide ratios of tumor/gray matter. Each patient has a mean tumor to gray matter ratio value and the median of these values across patients is reported.|Baseline|The analysis population consists of participants, from both the phase I part and the phase II part, treated at any dose level who had a baseline PET scan.||Ratio||Full Range|Median
702350|NCT00079339|Secondary|Change From Baseline in Volume FLAIR at Two Weeks After Completion of Radiation|This study attempted to investigate in an exploratory manner the effect of treatment on changes in various neuroimaging variables. Neuroimaging changes may have some association with outcome (response, survival, etc.). Volume FLAIR is one parameter obtained from standard magnetic resonance imaging (MRI) studies of the brain. Volume FLAIR was obtained at baseline and within two weeks after completion of radiation.|Baseline and two weeks post completion of radiation|The analysis population consists of participants, from both the phase I part and the phase II part, treated at any dose level who had a baseline volume FLAIR value and a second volume FLAIR value measured at approximately 8 weeks after starting treatment.||cubic centimeters||Full Range|Median
702351|NCT00079339|Secondary|Change From Baseline in Diffusion Ratio at Two Weeks After Completion of Radiation.|This study attempted to investigate in an exploratory manner the effect of treatment on changes in neuroimaging meaurements. Neuroimaging changes may have some association with outcome (response, survival, etc.). Diffusion values are obtained from magnetic resonance diffusion imaging and were measured at baseline, every 8 weeks for the first 48 weeks, and then every 12 weeks until treatment is discontinued.|Baseline and two weeks post completion of radiation|The analysis population consists of participants, from both the phase I part and the phase II part, treated at any dose level who had a baseline diffusion ratio value and a second diffusion ratio value measured at approximately 8 weeks after starting treatment.||Ratio||Full Range|Median
702352|NCT00079339|Secondary|Change From Baseline in Perfusion Ratio at Two Weeks After Completion of Radiation|This study attempted to investigate in an exploratory manner the effect of treatment on changes in neuroimaging meaurements. Neuroimaging changes may have some association with outcome (response, survival, etc.). Perfusion values are obtained from magnetic resonance perfusion imaging and were measured at baseline, every 8 weeks for the first 48 weeks, and then every 12 weeks until treatment is discontinued.|Baseline and two weeks post completion of radiation|The analysis population consists of participants, from both the phase I part and the phase II part, treated at any dose level who had a baseline perfusion ratio value and a second perfusion ratio value measured at approximately 8 weeks after starting treatment.||Ratio||Full Range|Median
702353|NCT00079339|Primary|Progression-free Survival (PFS)|PFS was defined as the interval from initiation of treatment to the earliest of disease progression (tumor increase of 25% over baseline tumor measurement; appearance of new lesion(s); or progressive/worsening neurological status) or death for patients who failed, or to the last date of follow up for patients without failure.|Assessed before the first dose of tipifarnib, every 8 weeks for the first 48 weeks, and then every 12 weeks.|Per protocol 40 participants who received at least one dose of tipifarnib were needed for this objective. The analysis population consists of phase I participants treated at the maximum tolerated dose (MTD) and the participants enrolled to the phase II part.||Months||Full Range|Median
702354|NCT00079339|Primary|Number of Participants in the Phase I Component With Dose-limiting Toxicities (DLTs) Observed During the First 8 Weeks (Courses 1 and 2) of Tipifarnib Therapy|The dose limiting toxicity (DLT) analysis population consists of phase I participants who developed DLT during the maximum tolerated dose (MTD) estimation period (courses 1 and 2) or who completed the MTD estimation period (courses 1 and 2) without DLTs. DLTs observed during courses 1 and 2 were used to estimate the MTD.|Day 1 of tipifarnib therapy to week 8|Per protocol, participants included phase I participants who developed dose-limiting toxicities during the maximum tolerated dose (MTD) estimation period (courses 1 and 2) or who completed the MTD estimation period (courses 1 and 2) without dose-limiting toxicities.||Participants|||Number
702355|NCT00079391|Secondary|Acute GVHD Overall|Incidence of acute GVHD grades II-IV (before and after T cell add back) Modified Glucksberg grading|First 100 days|||participants|||Number
702356|NCT00079391|Secondary|Acute Graft Versus Host Disease (Before Day 60 T Cell Add Back)|"Incidence of acute Graft versus host disease (GVHD) grades II-IV (before day 60 T cell add back)
Modified Glucksberg grading"|First 60 days|Per protocol||participants|||Number
702357|NCT00079391|Secondary|Cumulative Incidence of Relapse|Kaplan Meier-estimate of relapse incidence|at 5 years post transplant|||percentage of participants|||Number
702358|NCT00079391|Secondary|Non Relapse Mortality.|"Non relapse mortality: death without relapse
Kaplan Meier estimate"|at 5 years post transplant|||percentage of participants|||Number
702359|NCT00079391|Secondary|Overall Survival|Kaplan Meier estimate of survival|at 5 years post transplant|||percentage of participants|||Number
702360|NCT00079391|Primary|The Proportion of Patients Who Develop Full Donor T Cell Chimerism at Day 30|"The proportion of patients who develop full donor CD3+ lymphocyte chimerism by day 30.
Full chimerism is defined as >95% donor alleles by molecular profiling (Short Tandem Repeat analysis)."|Day 30|Per protocol; only patients who survived to day 30 and were evaluable.||percentage of participants|||Number
702361|NCT00079417|Secondary|Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0||From the beginning of treatment, assessed up to 10 years||||||
702362|NCT00079417|Secondary|Event-free Survival Rate (EFSR) Defined as the Need for Non-protocol Chemotherapy, Enucleation, or EBRT at the Patient Level|EFSR will be estimated for patients who respond to vincristine and carboplatin after an initial 1 cycle of chemoreduction|Up to 10 years||||||
702363|NCT00079417|Secondary|Response Rate (RR) at Patient and Eye Levels After the First Course|RR will be estimated. The response after 1 course of chemotherapy will be used to better define response to this neoadjuvant systemic chemotherapy, prior to the use of local ophthalmic therapy. Response to subsequent courses will help define response to combined systemic chemotherapy and local ophthalmic therapy.|Up to 10 years||||||
702364|NCT00079417|Secondary|Use of Nonprotocol Chemotherapy|Use of nonprotocol chemotherapy at the patient level and enucleation and EBRT will be descriptively summarized at the patient and eye levels.|Up to 10 years||||||
702365|NCT00079417|Primary|Event-free Survival|Proportion of patients with event free survival at 2 years. An event is defined as the need for non-protocol therapy, defined as additional on-protocol chemotherapy, enucleation or external beam radiation, among patients with Group B intraocular tumors with a schedule of neoadjuvant 2-agent (Vincristine/Carboplatin) chemotherapy (chemo-reduction) and standardized local ophthalmic therapy.|At 2 years|One patient was ineligible and was not included in the analysis.||Proportion||95% Confidence Interval|Number
702366|NCT00079677|Primary|Number of Participants Who Had at Least Minimal Improvement in CGI-C Ratings at Week 12 or Last Post-baseline Visit.|Number of participants who had at least minimal improvement in CGI-C ratings at Week 12 or last post-baseline visit. The CGI-C uses the following categories and scoring assignments: 1=Very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; and 7=Very much worse. Severity of illness was assessed at baseline by the CGI-S, which consists of the following categories: 1=Normal (shows no signs of illness); 2=Borderline ill; 3=Mildly (Slightly) ill; 4=Moderately ill; 5=Markedly ill; 6=Severely ill; and 7=Among the most extremely ill patients.|12 weeks or last post-baseline visit|"Safety Analysis set of 259 total patients: 4 participants withdrew after randomization but prior to receiving study drug.
Full Analysis set of 236 total patients: 23 patients that had withdrawn from the study were non-evaluable for efficacy."||Participants|||Number
702367|NCT00079677|Primary|Maintenance of Wakefulness Test (MWT)|The Maintenance of Wakefulness Test (MWT) is an objective assessment of sleepiness that measures the ability of a subject to remain awake. Long latencies to sleep are indicative of a patient’s ability to remain awake. The change from baseline in the mean sleep latency from the MWT (average of 4 tests at 0900, 1100, 1300, and 1500) was analyzed at weeks 4, 8, and 12. The primary efficacy variable was the mean change from the baseline assessment in MWT sleep latency as assessed at week 12 (or last post-baseline visit).|Change from baseline at 12 weeks or early termination|"Safety Analysis set of 259 total patients: 4 participants withdrew after randomization but prior to receiving study drug.
Full Analysis set of 236 total patients: 23 patients that had withdrawn from the study were non-evaluable for efficacy."||Minutes||Standard Deviation|Mean
702368|NCT00079781|Primary|Responder Rate|"Percentage of subjects with a 50% or greater reduction in mean seizure frequency during the post-implant Evaluation Period (4 months or 112 days) compared to pre-implant baseline (collected during the Prospective Seizure Frequency study). The primary effectiveness endpoint would be met with an observed responder rate of 13% or more.
The effectiveness endpoint was only calculated for the Treatment Population. The endpoint was used to support a Pivotal Study, not to demonstrate efficacy when compared to a control/sham group.
The primary effectiveness endpoint was met."|Pre-implant baseline through 4 months post-implant|||Percent of participants|||Number
702369|NCT00079781|Primary|Short-term Chronic SAE Rate|"The RNS® System Short-term Chronic SAE rate = the percentage of implanted subjects having a serious adverse event (SAE) for the surgical implant procedure and the following 3 months (84 days), whether reported as device-related or not.
This outcome measure is met when the upper limit of the one-sided 95% confidence interval of the observed RNS® System Short-term Chronic SAE Rate does not exceed the upper limit of the one-sided 95% confidence interval of the historical short-term chronic SAE rate for deep brain stimulation for movement disorders from the published literature (rate = 36%; upper CI = 46%). The comparator was calculated based upon the literature, therefore the number of participants analyzed is unknown/not applicable.
The primary safety outcome measure was met."|Initial implant through 3 months post-implant|||percentage of participants||95% Confidence Interval|Number
702370|NCT00079781|Primary|Acute SAE Rate|"RNS® System Acute SAE Rate = the percentage of subjects having a serious adverse event (SAE) for the surgical implant procedure and the following month (28 days), whether reported as device-related or not.
This outcome measure is met when the upper limit of the one-sided 95% confidence interval of the observed RNS® System Acute SAE Rate does not exceed the upper limit of the one-sided 95% confidence interval of the literature-based acute SAE rate associated with the implantation of intracranial electrodes for localization procedures and epilepsy surgery combined as documented in the literature (rate = 19%; upper CI = 28%). The comparator was calculated based upon the literature, therefore the number of participants analyzed is unknown/not applicable.
The primary safety outcome measure was met."|Initial implant through 1 month post-implant|||percentage of participants||95% Confidence Interval|Number
702371|NCT00079937|Primary|Percentage of Participants With at Least 1 Adverse Event|See Adverse Events module for details.|Baseline to end of the study (Week 68)|Safety population: All patients who received any study drug and had at least 1 post-baseline safety assessment.||Percentage of participants|||Number
702372|NCT00079937|Secondary|Change in Pediatric Asthma Quality of Life Questionnaire (Standardized) [PAQLQ(S)] Scores From Baseline to the End of the 24-week Fixed-dose Steroid Treatment Period (Week 24)|PAQLQ measures functional problems that are most troublesome to children with asthma. PAQLQ has 23 questions in 3 domains (activity limitation=5, emotional function=8, symptoms=10). Patients responded to each question on a 7-point Likert scale. Overall PAQLQ score is mean of 23 questions; each domain score is mean of questions in that domain. Minimum possible value is 1 (maximum impairment); maximum possible value is 7 (no impairment). Positive change indicated improvement. The analysis included country, baseline PAQLQ value, and dosing schedule (2-weekly/4-weekly) as factors and covariates.|Baseline to the end of the 24-week fixed-dose steroid treatment period (Week 24)|Modified intent-to-treat population: All patients who were randomized, excluding patients from 2 sites due to Good Clinical Practice non-compliance. Excluded patients were replaced with patients at other sites to maintain statistical power.||Units on a scale||95% Confidence Interval|Least Squares Mean
702373|NCT00079937|Secondary|Change in Mean Daily Number of Puffs of Asthma Rescue Medication From Baseline to the End (Last 4 Weeks) of the 24-week Fixed-dose Steroid Treatment Period|Patients were instructed to record the number of puffs of rescue medication they took twice daily in a diary. The mean daily number of puffs during the last 4 weeks of the 24-week fixed-dose steroid treatment period was calculated; for patients who discontinued prematurely, the mean of the last 28 days before discontinuation was calculated. A negative change in mean daily number of puffs indicated reduced use of rescue medication.|Baseline to the end (last 4 weeks) of the 24-week fixed-dose steroid treatment period|Modified intent-to-treat population: All patients who were randomized, excluding patients from 2 sites due to Good Clinical Practice non-compliance. Excluded patients were replaced with patients at other sites to maintain statistical power.||Puffs||Standard Deviation|Mean
702374|NCT00079937|Secondary|Rate of Clinically Significant Asthma Exacerbations Per Patient in the 52-week Treatment Period|A clinically significant asthma exacerbation was defined as a worsening of asthma symptoms, as judged clinically by the investigator, requiring doubling of the baseline inhaled corticosteroid dose and/or treatment with systemic rescue corticosteroids for at least 3 days. The exacerbations rate per patient was derived using Poisson model adjusted by time at risk and the following covariates: country, exacerbation history, and dose schedule. A patient's person-days at risk was taken as the total amount of time (in days) he/she spent in the 52-week treatment period.|Baseline to end of the treatment period (Week 52)|Modified intent-to-treat population: All patients who were randomized, excluding patients from 2 sites due to Good Clinical Practice non-compliance. Excluded patients were replaced with patients at other sites to maintain statistical power.||Exacerbations per patient per year||95% Confidence Interval|Mean
702419|NCT00073008|Secondary|Progression-free Survival (PFS) at Four Months in the Targeted Population|Percentage of participants in the Targeted Population, at 4 months after starting study drug, who were alive and without disease progression.|From randomization and then every 8 weeks up to four months|Targeted Population||percentage of participants|||Number
702467|NCT00081731|Primary|Composite Endpoint: Death From Cardiovascular or Renal Causes, Stroke, Myocardial Infarction, Hospitalization for CHF, Progressive Renal Insufficiency, or Permanent Renal Replacement Therapy|Only the first event per participant is included in the composite|Measured at every 3 months for the first year and annually thereafter|||participants|||Number
702375|NCT00079937|Primary|Rate of Clinically Significant Asthma Exacerbations Per Patient in the 24-week Fixed-dose Steroid Treatment Period|A clinically significant asthma exacerbation was defined as a worsening of asthma symptoms, as judged clinically by the investigator, requiring doubling of the baseline inhaled corticosteroid dose and/or treatment with systemic rescue corticosteroids for at least 3 days. The exacerbations rate per patient was derived using Poisson model adjusted by time at risk and the following covariates: country, exacerbation history, and dose schedule. A patient’s person-days at risk was taken as the total amount of time (in days) he/she spent in the 24-week fixed-dose steroid treatment period.|Baseline to end of the fixed-dose steroid treatment period (Week 24)|Modified intent-to-treat population: All patients who were randomized, excluding patients from 2 sites due to Good Clinical Practice non-compliance. Excluded patients were replaced with patients at other sites to maintain statistical power.||Exacerbations per patient per 24-weeks||95% Confidence Interval|Mean
702376|NCT00079937|Secondary|Change in Mean Nocturnal Asthma Symptom Score From Baseline to the End (Last 4 Weeks) of the 24-week Fixed-dose Steroid Treatment Period|Nocturnal asthma symptom was measured daily on a scale of 0 to 4 in response to the question “How did you sleep last night?”, with 0 as the best response and 4 as the worst response. The mean of the last 4 weeks of the 24-week fixed-dose steroid treatment period was calculated; for patients who discontinued prematurely, the mean of the last 28 days before discontinuation was calculated. A negative change in mean score indicated improvement.|Baseline to the end (last 4 weeks) of the 24-week fixed-dose steroid treatment period|Modified intent-to-treat population: All patients who were randomized, excluding patients from 2 sites due to Good Clinical Practice non-compliance. Excluded patients were replaced with patients at other sites to maintain statistical power.||Units on a scale||Standard Deviation|Mean
702377|NCT00080119|Secondary|Time From Randomization to First New Grade 3 or Worse Adverse Event Among HIV-infected and Perinatally Exposed, HIV-uninfected Children|Signs, symptoms and laboratory values were graded according to the Division of AIDS Adverse Event Grading System. Any event of grade 3 or higher not present at entry that occurred after randomization was classified as a new event. Results report percent of participants with a new event by week 96 calculated using the Kaplan-Meier method.|Through to week 96|Includes all starting treatment. Time from randomization to first new adverse event (AE) calculated. For lab toxicities, censored at visit following permanent discontinuation of study drugs. For signs/symptoms, participants in follow-up at 96 wks (+12) with no new grade >=3 AE censored at 96 wks. Participants LTF <96 wks censored at LTF.||Percent of participants|||Number
702378|NCT00080119|Secondary|Time From Randomization to Death Among HIV-infected and Perinatally Exposed, HIV-uninfected Children|Deaths from any cause were included. Results report percent of participants dying by week 96 calculated using the Kaplan-Meier method.|Through to week 96|Includes all starting study treatment. Time from randomization to death was calculated. Participants LTF <96 weeks (+12 wks) censored at the time of LTF. Participants in follow-up at 96 wks (+12 wks) censored at 96 weeks. HIVpos on study when study was discontinued were censored at their discontinuation visit.||Percent of participants|||Number
702379|NCT00080119|Secondary|Time From Randomization to Development of TB Infection Among HIV-infected and Perinatally Exposed, HIV-uninfected Children|Criteria for diagnosis with TB infection were outlined in the protocol. TB infection included TB disease (see primary outcome measure 1 for definition) and latent TB infection. Latent TB infection was diagnosed by a positive TST based on a PPD performed at week 96. Participant records were reviewed by an Endpoint Review Group to verify that participants had met the criteria for TB infection. Results report percent of participants reaching TB infection by week 96 calculated using the Kaplan-Meier method.|Through to week 96|Includes all starting study treatment. Time from randomization to development of TB infection was calculated. Participants LTF <96 weeks (+12 wks) censored at the time of LTF. Participants in follow-up at 96 wks free of TB infection were censored at 96 wks. HIVpos on study when study discontinued censored at their discontinuation visit.||Percent of participants|||Number
702380|NCT00080119|Secondary|Time From Randomization to Development of TB Disease Among HIV Infected and Perinatally Exposed, HIV-uninfected Children|Criteria for diagnosis with TB disease were: Definite-isolation of M.tb or positive stain on CSF; Probable-positive AFB stain on fluids/tissues other than CSF and sufficient clinical criteria/radiographic evidence suggestive of TB; Possible-abnormal chest radiograph suggestive of PTB and either a +ve TST or minimum score on algorithm to diagnose clinical TB. All records were reviewed by an Endpoint Review Group to verify that participants had met the criteria for TB disease. Results report percent of participants reaching TB disease/death by week 96 calculated using the Kaplan-Meier method.|Through to week 96|Includes all starting study treatment. Time from randomization to development of TB disease was calculated. Participants LTF <96 wks (+12 wks) censored at time of LTF. Participants in follow-up at 96 wks free of TB disease censored at 96 wks. HIVpos on study when study discontinued were censored at their discontinuation visit.||Percent of participants|||Number
702381|NCT00080119|Secondary|Time From Randomization to Development of TB Disease or Death Among Perinatally Exposed, HIV-uninfected Children|Criteria for diagnosis with TB disease were: Definite-isolation of M.tb or positive stain on CSF; Probable-positive AFB stain on fluids/tissues other than CSF and sufficient clinical criteria/radiographic evidence suggestive of TB; Possible-abnormal chest radiograph suggestive of PTB and either a +ve TST or minimum score on algorithm to diagnose clinical TB. All records were reviewed by an Endpoint Review Group to verify that participants had met the criteria for TB disease. Results report percent of participants reaching TB disease/death by week 96 calculated using the Kaplan-Meier method.|Through to week 96|Includes HIVneg who started study treatment. Time from randomization to the first of TB disease/death was calculated. Participants lost-to-follow-up before 96 weeks (+12 week window)were censored at the time of loss-to-follow-up. Participants in follow-up at 96 weeks who were free of TB disease were censored at 96 weeks (+12 week window).||Percent of participants|||Number
702382|NCT00080119|Secondary|Time From Randomization to HIV Disease Progression or Death Among HIV-infected Children|HIV disease progression was defined as any advancement in Centers for Disease Control (CDC) disease category from entry or death. If a participant was CDC disease category C at entry progression was defined as death. Results report percent of participants with HIV progression or death by week 96 calculated using the Kaplan-Meier method.|Through to week 96|Includes HIVpos starting study treatment. Time from randomization to first of disease progression/death calculated. Censored if LTF <96 wks, at 96 wks (if on study) or at discontinuation visit. Participants found to be HIVneg upon repeat testing could only progress by meeting a death endpoint.||Percent of participants|||Number
702383|NCT00080119|Secondary|Time From Randomization to Development of TB Infection or Death Among HIV-infected Children|Criteria for diagnosis with TB infection were outlined in the protocol. TB infection included TB disease (see primary outcome measure 1 for definition) and latent TB infection. Latent TB infection was diagnosed by a positive TST based on a PPD performed at week 96. Participant records were reviewed by an Endpoint Review Group to verify that participants had met the criteria for TB infection. Results report percent of participants reaching TB infection or death by week 96 calculated using the Kaplan-Meier method.|Through to week 96|HIVpos starting study treatment were included. Time from randomization to first of TB infection/death was calculated. Participants LTF <96 weeks (+12 wk) censored at the time LTF. Participants in follow-up at 96 wks free of TB infection censored at 96 wks. Participants on study when study discontinued were censored at discontinuation visit.||Percent of participants|||Number
702384|NCT00080119|Primary|Time From Randomization to Development of TB Infection or Death Among Perinatally Exposed, HIV-uninfected Children|Criteria for diagnosis with TB infection were outlined in the protocol. TB infection included TB disease (see primary outcome measure 1 for definition) and latent TB infection. Latent TB infection was diagnosed by a positive tuberculin skin test (TST) based on a purified protein derivative (PPD) performed at week 96. Participant records were reviewed by an Endpoint Review Group to verify that participants had met the criteria for TB infection. Results report percent of participants reaching TB infection or death by week 96 calculated using the Kaplan-Meier method.|Through to week 96|HIVneg who started study treatment were included. Time from randomization to first of TB infection/death was calculated. Participants lost-to-follow-up before 96 wks were censored at the time of loss-to-follow-up. Participants in follow-up at 96 weeks (+12 week window) who were free of TB infection were censored at 96 weeks (+12 week window).||Percent of participants|||Number
702385|NCT00080119|Primary|Time to Development of Tuberculosis (TB) Disease or Death Among HIV-infected Children|Criteria for diagnosis with TB disease: Definite-isolation of Mycobacterium TB (M.tb) or +ve stain on cerebrospinal fluid (CSF); Probable- +ve acid fast bacilli (AFB) stain on fluids/tissues other than CSF and sufficient clinical criteria/radiographic evidence suggestive of TB; Possible-abnormal chest radiograph suggestive of pulmonary TB (PTB) and either a +ve tuberculin skin test (TST) or minimum score on algorithm for clinical TB. Records reviewed by Endpoint Review Group. Results report percent of participants reaching TB disease/death by week 96 calculated using the Kaplan-Meier method.|Through to week 96|Includes HIVpos who started study treatment. Time from randomization to TB disease/death was calculated. Participants lost-to-follow-up (LTF) <96 wks (+12wks) censored at the time of LTF. Participants in follow-up at 96 wks free of TB disease censored at 96 wks. Participants on study when study discontinued censored at discontinuation visit.||Percent of participants|||Number
702386|NCT00080223|Secondary|Overall Survival|Survival was analyzed as time from first study dose to death (all-cause mortality) with surviving participants censored at their last available assessment.|First dosing of study treatment until death (up to 604 weeks)|All treated participants||weeks||95% Confidence Interval|Median
702387|NCT00080223|Secondary|Resting Oxygen Saturation by Pulse Oximetry (SpO2)|SpO2 is the percentage of oxygen saturation in the blood. Oxygen level (oxygen saturation) of the blood was measured using pulse oximetry on room air.|Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480|All treated participants. “n” = participants who were evaluable for specified time point.||percentage of oxygen saturation||Standard Deviation|Mean
702388|NCT00080223|Secondary|Hemoglobin (Hgb)-Corrected Percent-Predicted Carbon Monoxide Diffusing Capacity (DLco)|DLco is a pulmonary function test, and measures the partial pressure difference between inspired and expired carbon monoxide. Predicted DLco is based on a formula using sex, age and height of a person. Predicted DLco = [Hbg-corrected DLco value (in milliliters per minute per millimeter mercury [mL/min/mmHg])/predicted DLco] * 100%|Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480|All treated participants. “n” = participants who were evaluable for specified time point.||percent predicted DLco||Standard Deviation|Mean
702389|NCT00080223|Secondary|Percent Predicted Forced Vital Capacity (FVC)|FVC is a standard pulmonary function test used to quantify respiratory muscle weakness. FVC is the volume of air that can forcibly be blown out from the lungs after full inspiration in the upright position, measured in liters. Predicted FVC is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FVC = (actual FVC value in liter)/(predicted FVC) * 100%|Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480|All treated participants. “n” = participants who were evaluable for specified time point.||percent predicted FVC||Standard Deviation|Mean
702390|NCT00080223|Primary|Percentage of Participants With a Treatment-Emergent Adverse Event (AE), Serious AE (SAE), Severe AE, Life-threatening AE, Death or Discontinuation Because of an AE|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs were classified as severe (Grade 3) in following cases: marked limitation in activity; some assistance usually required; medical intervention/ therapy required, hospitalization possible. Treatment-emergent AEs were those occurring on or after the first dosing day and up to 28 days after discontinuation of study treatment, and those occurring before treatment that worsened after the first study dose. AE included serious as well as non-serious AEs.|Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)|All treated participants||percentage of participants|||Number
702391|NCT00080288|Primary|Clinical Global Impression of Change (CGI-C)|Number of participants who had at least minimal improvement in CGI-C ratings at Week 12 or last post-baseline visit. The CGI-C uses the following categories and scoring assignments: 1=Very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; and 7=Very much worse. Severity of illness was assessed at baseline by the CGI-S, which consists of the following categories: 1=Normal (shows no signs of illness); 2=Borderline ill; 3=Mildly (Slightly) ill; 4=Moderately ill; 5=Markedly ill; 6=Severely ill; and 7=Among the most extremely ill patients.|up to 12 weeks|"Safety Analysis set of 245 total patients: 9 participants withdrew after randomization but prior to receiving study drug
Full Analysis set of 216 total patients: 29 patients that had withdrawn from the study were non-evaluable for efficacy."||Participants|||Number
702392|NCT00080288|Primary|Multiple Sleep Latency Test (MSLT)|The Multiple Sleep Latency Test (MSLT) is an objective assessment of sleepiness that measures the ability of a subject to remain awake. Long latencies to sleep are indicative of a patient’s ability to remain awake. Mean sleep latency from MSLT was measured for five 20-minute (maximum) MSLT naps performed at scheduled visits (2400 [midnight], 0200, 0400, 0600, and 0800).The MSLT was administered at weeks 4, 8, and 12. The primary efficacy variable was the mean change from the baseline assessment in MSLT sleep latency as assessed at week 12 (or last postbaseline visit).|up to 12 weeks|"Safety Analysis set of 245 total patients: 9 participants withdrew after randomization but prior to receiving study drug
Full Analysis set of 216 total patients: 29 patients that had withdrawn from the study were non-evaluable for efficacy."||Minutes||Standard Deviation|Mean
702393|NCT00080301|Secondary|Symptom Assessment Score Changes From Baseline for Functional Assessment of Cancer Therapy-Breast Symptom Index (FBSI)|Quality of life, as measured by the FBSI, an 8-item, participant-reported instrument to measure symptoms. Each item has 5 possible responses ranging from 0 (not at all) to 4 (very much). The scoring was conducted according to the Functional Assessment of Chronic Illness Therapy manual, Version 4; higher scores reflect fewer symptoms.|Baseline and prior to each 21-day cycle of treatment, and at first posttreatment follow-up assessment.|Analysis was conducted on all randomized participants on an intent to treat basis.(Note: while table only reports data up to 24 wks, which represents most results, statistical analysis includes ALL assessments through study and follow-up; a few participants were assessed after more than 100 weeks.)||units on a scale||95% Confidence Interval|Mean
702394|NCT00080301|Secondary|Treatment-related Safety Summary|Laboratory values, adverse events, and other symptoms were graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTC) Version 3.0|safety was assessed on a continual basis every cycle while on-treatment and every 4 weeks post treatment until toxicities resolved or were deemed irreversible.|All treated participants; all participants who received at least 1 dose of study therapy.Participants with baseline hepatic impairment (combination arm, n = 29; capecitabine arm, n = 35), defined as Grade ≥2 AST, ALT or Grade ≥1 total bilirubin, were contraindicated due to disproportionate number of toxic deaths.||Participants|||Number
702395|NCT00080301|Secondary|Overall Survival (OS)|OS was defined as the time from randomization to death. Participants who did not die at the time of the analysis were censored at the latest follow-up date. Median OS with 95% CI was estimated using the Kaplan Meier product limit method.|from date of randomization until death|Overall survival was analyzed on all randomized patients on an intent to treat basis.||Months||95% Confidence Interval|Median
702396|NCT00080301|Secondary|Time to Response Per IRRC|Time to response was summarized using descriptive statistics and was defined as the time from first dose of study treatment until measurement criteria were first met for Partial Response or Complete Response.|based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity|Results for time to response apply to only those subjects with a response (defined as complete or partial response)||weeks||Full Range|Median
702397|NCT00080301|Secondary|Duration of Response Per IRRC|"Computed for all patients with a best response of Partial or Complete per RECIST (a 4-item scale as described in previous outcome measure), calculated from the time when these criteria were first met until the first date of documented progression or death."|based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity|Results for duration of response apply to only those subjects with a response (defined as complete or partial response).||months||95% Confidence Interval|Median
702398|NCT00080301|Secondary|Overall Response Rate (ORR) Per IRRC|"Participants with best response of Complete or Partial according to Response Evaluation Criteria in Solid Tumors (RECIST) a 4-item scale wherein complete response=disappearance of all target lesions and partial response=30% decrease in the sum of the longest diameter of target lesions"|based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity|The analysis of ORR was conducted on all randomized patients on an intent to treat basis.||percent||95% Confidence Interval|Mean
702399|NCT00080301|Primary|Progression-free Survival (PFS) Per Independent Radiology Review Committee (IRRC)|PFS defined as the time in months from randomization to date of progression. Patients who died without a reported prior progression were considered to have progressed on date of death; those who didn’t progress or die were censored on date of last tumor assessment. Median PFS time with 95% CI estimated using the Kaplan Meier product limit method.|based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity|PFS was analyzed on all randomized patients on an intention to treat basis.||Months||95% Confidence Interval|Median
702400|NCT00080470|Primary|Freedom From Major Complications||5 years|||Number of Adverse Events|||Number
702401|NCT00080470|Primary|Number of Leaks Per Day||12 months|||Number of Leaks Per Day||Standard Deviation|Mean
702402|NCT00080483|Other Pre-specified|Increased Cortical Thickness and Cortical Density, as Determined by Peripheral Quantitative Computed Tomography of the Tibial Metaphysis||2 years||||||
702403|NCT00080483|Other Pre-specified|Improved Architectural Parameters of Trabecular Bone Reflecting Connectivity, as Determined by Magnetic Resonance Imaging||2 years||||||
702404|NCT00080483|Other Pre-specified|Increased Trabecular Thickness, as Determined by Magnetic Resonance of the Distal Tibia||2 years||||||
702405|NCT00080483|Primary|MicroMRI-derived Structural (Bone Volume Fraction-BVF) of the Distal Tibia at Baseline and After One and Two Years of Treatment.|Increased bone volume fraction (the fraction of bone that is bone, as opposed to the fraction that is marrow), as determined by magnetic resonance of the distal tibia|baseline, one year, two years|All subjects who had both baseline and one year evaluations||unitless||Standard Error|Mean
702406|NCT00080535|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|12/31/2004 - 8/17/2011|||Participants|||Number
702420|NCT00073008|Other Pre-specified|Tumor Response in the Non-Targeted Population Through the End of Treatment|Baseline and then every 8 weeks through end of treatment (end of treatment for each participant was dependent on when the participant withdrew from study therapy due to disease progression, an adverse event or participant decision)|Baseline and then every 8 weeks through end of treatment|Non-Targeted Population: all randomized participants who received at least one dose of study drug but who did not meet the criteria for inclusion in the Targeted Population.||participants|||Number
702407|NCT00080535|Primary|Response Rate|Response is assessed by the International Workshop's Response Criteria (IWRC) for Non-Hodgkin's Lymphomas which favors the sum of the bidimensional products for tumor measurements. Complete response is no evidence of disease. Complete response unconfirmed (CRu) is a complete response in every category except CRu in lymph nodes. Partial response is a partial response in every measurable category with non-progressive disease elsewhere. Progressive disease is progressive disease in every category. Stable disease is neither partial response nor progressive disease. For additional details about the IWRC see the protocol link module.|Patients were followed for at least 30 days after last treatment. Because the protocol allows 6 treatment cycles, this can be up to 7 months.|||Participants|||Number
702408|NCT00072761|Primary|Recurrence of an Infarct, Defined as a Stroke or a New or Enlarged Silent Cerebral Infarct|The primary end point was the recurrence of infarct or hemorrhage as determined by neuroimaging, clinical evidence of permanent neurologic injury, or both. A new infarct had to meet the criteria for a silent cerebral infarction; an enlarged silent cerebral infarct was defined as a previously identified silent cerebral infarct that increased by at least 3 mm along any linear dimension in any plane on MRI.|From study entry to study exit|Randomization assignments were provided by the statistical data coordinating center with the use of a permuted block design, with stratification according to site, age, and sex. Participants were assigned in a 1:1 ratio to the observation or transfusion group and were followed until study exit or study endpoint.||infarct recurrence per 100 person years|||Number
702409|NCT00073008|Secondary|Review of Non-small Cell Lung Cancer (NSCLC) Histology (Cell Type) Using an Independent Review|Comparison of the specific cell type (histology) of non-small cell lung cancer from participant’s tissue samples, as determined by local pathologist, to the type determined by an independent pathologist. Based on the interim analysis at the end of Stage 1, and predefined stopping rules for futility, further enrollment into the study was stopped due to lack of efficacy on both treatment arms; therefore, NSCLC histology was not analyzed.|Anytime from Baseline through end of study||||||
702410|NCT00073008|Secondary|Overall Survival|Overall survival is measured as the time from randomization until death due to any cause. Based on the interim analysis at the end of Stage 1, and predefined stopping rules for futility, further enrollment into the study was stopped due to lack of efficacy on both treatment arms; therefore, overall survival was not analyzed.|From randomization and then every 8 weeks while on study drug and then every 3 months as follow-up until death||||||
702411|NCT00073008|Secondary|Time to Tumor Progression|Time from randomization until the first documented sign of disease progression or death due to any cause, if sooner. Based on the interim analysis at the end of Stage 1, and predefined stopping rules for futility, further enrollment into the study was stopped due to lack of efficacy on both treatment arms; therefore, time to tumor progression was not analyzed.|From randomization and then every 8 weeks to disease progression or death||||||
702412|NCT00073008|Secondary|Duration of Response|For those participants who show a complete or partial response, duration of response would be time from first documented evidence of response (complete or partial response by RECIST) until disease progression or death, if sooner. Based on the interim analysis at the end of Stage 1, and predefined stopping rules for futility, further enrollment into the study was stopped due to lack of efficacy on both treatment arms; therefore, duration of response was not analyzed.|Time from first documented evidence of response to study treatment and then every 8 weeks until disease progression or death||||||
702413|NCT00073008|Secondary|Time to Response|Time from randomization until first documented evidence of partial or complete tumor response, measured using standard criteria (RECIST). Based on the interim analysis at the end of Stage 1, and predefined stopping rules for futility, further enrollment into the study was stopped due to lack of efficacy on both treatment arms; therefore, time to response was not analyzed.|From randomization and then every 8 weeks to time of response to study drug||||||
702414|NCT00073008|Secondary|Quality of Life|Standard survey forms were completed by the participant at scheduled assessments to find out how the participant felt while on study. Based on the interim analysis at the end of Stage 1, and predefined stopping rules for futility, further enrollment into the study was stopped due to lack of efficacy on both treatment arms; therefore, quality of life was not analyzed.|Baseline and then every 4 weeks through end of treatment||||||
702415|NCT00073008|Secondary|Pharmacogenetics (PgX)|To (1) investigate the relationship between genetic variants in specific genes and the absorption, distribution, metabolism, and excretion (pharmacokinetics) of lapatinib, and to (2) investigate the relationship between genetic variants in select genes in DNA and the response (safety, efficacy, and tolerability) to lapatinib. Based on the interim analysis at the end of Stage 1, and predefined stopping rules for futility, further enrollment into the study was stopped due to lack of efficacy on both treatment arms; therefore, pharmacogenetics were not analyzed.|From randomization at every 4-week assessment through end of treatment||||||
702416|NCT00073008|Secondary|Pharmacokinetics (PK) of Lapatinib|To characterize the PK (absorption, distribution, metabolism, and excretion) of the study drug lapatinib in the participant population. PK is defined as the concentration of drug in a participant’s blood at certain time points after the drug was taken by mouth. Based on the interim analysis at the end of Stage 1, and predefined stopping rules for futility, further enrollment into the study was stopped due to lack of efficacy on both treatment arms; therefore, pharmacokinetics were not analyzed.|From randomization to time of PK period completed: Day 1 (first dose) and Days 2, 28, and 29 while participant was on study drug||||||
702417|NCT00073008|Secondary|The Number of Participants Who Showed Certain Biomarkers in Their Serum or Tumor Tissue|To further characterize the participant population, these biomarkers could be tested: serum levels of ErbB1 and ErbB2; intra-tumoral expression of ErbB1, ErbB2, etc.; mutations in ErbB1, ErbB2, and k-ras. Based on the interim analysis at the end of Stage 1, and predefined stopping rules for futility, further enrollment into the study was stopped due to lack of efficacy on both treatment arms; therefore, serum biomarkers were not analyzed.|From randomization to disease progression (for serum biomarkers) or until analyses of tumor tissue samples||||||
702418|NCT00073008|Secondary|Progression-free Survival (PFS) at Four Months in the Non-Targeted Population|Percentage of participants in the Non-Targeted Population, at 4 months after starting study drug, who were alive and without disease progression.|From randomization and then every 8 weeks up to four months|Non-Targeted Population: all randomized participants who received at least one dose of study drug but who did not meet the criteria for inclusion in the Targeted Population.||percentage of participants|||Number
702421|NCT00073008|Primary|Tumor Response in the Targeted Population Through the End of Treatment|Disease progression and tumor response (number of participants achieving a complete response [CR] or partial response [PR]), using standardized criteria (Response evaluation criteria in solid tumors). CR, disappearance of all target lesions; PR, 30% decrease in the sum of the longest diameter of target lesions; progressive disease, 20% increase in the sum of the longest diameter of target lesions; stable disease, small changes that do not meet above criteria. Disease assessment was done at baseline and then every 8 weeks after starting treatment, until the participant discontinued treatment.|Baseline and then every 8 weeks through end of treatment|Targeted Population: all randomized participants who received at least one dose of study drug and had either the histological subtypes of adenocarcinoma with bronchioloalveolar carcinoma features or pure bronchioloalveolar carcinoma, or were never smokers with any histology of non-small cell lung cancer (NSCLC)||participants|||Number
702422|NCT00073021|Secondary|Percentage of Treatment Success Patients at Week 3, ITT Population|Treatment success defined as complete response (PGA score 0 and complete resolution of stool frequency, rectal bleeding, PFA (patient's functional assessment), normal sigmoidoscopy) or partial response (improvement from baseline PGA and improvement in 1 clinical assessment [stool frequency, rectal bleeding, PFA, sigmoidoscopy] and no worsening in any other clinical assessments)|3 Weeks|ITT Patients with Moderate Disease [PGA = 2] at Baseline||Percentage of Participants|||Number
702423|NCT00073021|Secondary|Percentage of Patients With Moderate, Left-Sided Disease at Baseline Classified as Treatment Success at Week 6, All Randomized Patients|Treatment success defined as complete response (PGA score 0 and complete resolution of stool frequency, rectal bleeding, PFA (patient's functional assessment), normal sigmoidoscopy) or partial response (improvement from baseline PGA and improvement in 1 clinical assessment [stool frequency, rectal bleeding, PFA, sigmoidoscopy] and no worsening in any other clinical assessments)|6 Weeks|All Randomized Patients with Moderate Disease [PGA=2] at Baseline. Left Sided Disease = proctitis, proctosigmoiditis or left-sided colitis||Percentage of Participants|||Number
702424|NCT00073021|Secondary|Mean Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 6, All Randomized Patients|IBDQ-32 questions divided into 4 categories: bowel, systemic, emotional and social. Each question graded with the following responses: 1-more than ever before, 2-extremely frequently, 3-very frequently, 4-moderate increase in frequency, 5-some increase in frequency, 6-slight increase in frequency or 7-not at all/normal; 1/worst thru 7/best. Scoring 32-224 - higher score better.|6 Weeks|All Randomized Patients with Moderate Disease [PGA=2] at Baseline. Questionnaire analyzable if patient answered 28 of 32 for total, 8/10 for bowel, 3/5 for systemic, 10/12 for emotional, 3/5 for social.||Scores on a Scale||Standard Error|Mean
702425|NCT00073021|Secondary|Mean Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 3, All Randomized Patients|IBDQ-32 questions divided into 4 categories: bowel, systemic, emotional and social. Each question graded with the following responses: 1-more than ever before, 2-extremely frequently, 3-very frequently, 4-moderate increase in frequency, 5-some increase in frequency, 6-slight increase in frequency or 7-not at all/normal; 1/worst thru 7/best. Scoring 32 - 224 - higher score better.|3 Weeks|All Randomized Patients with Moderate Disease[PGA=2] at Baseline. Questionnaire analyzable if patient answered 28 of 32 for total, 8/10 for bowel, 3/5 for systemic, 10/12 for emotional, 3/5 for social.||Scores on a Scale||Standard Error|Mean
702426|NCT00073021|Secondary|Percentage of Patients With Improvement in Physician Global Assessment (PGA)Score, ITT Population, Week 6|PGA -Physician's Global Assessment - 0=quiescent disease (all parameters 0), 1=mild disease (parameters mostly 1's) 2=moderate (parameters mostly 2's), 3=severe (parameters mostly 3's) [parameters: combination of stool frequency, rectal bleeding, PFA & sigmoidoscopy findings] If scoring equal default to physician judgement.|6 Weeks|ITT Population with Moderate Disease [PGA=2] at Baseline||Percentage of Participants|||Number
702427|NCT00073021|Secondary|Percentage of Patients With Improvement in Patient's Functional Assessment (PFA), ITT Population, Week 6|PFA - 0=generally well, 1=fair, 2=poor, 3=terrible|6 Weeks|ITT Population with Moderate Disease [PGA=2] at Baseline||Percentage of Participants|||Number
702428|NCT00073021|Secondary|Percentage of Patients With Improvement in Rectal Bleeding, ITT Population, Week 6|Rectal Bleeding (0=no blood seen, 1=streaks of blood with stool less than half of the time, 2=obvious blood with stool most of the time, 3=blood alone passed)|6 Weeks|ITT Population with Moderate Disease [PGA=2] at Baseline||Percentage of Participants|||Number
702429|NCT00073021|Secondary|Percentage of Patients With an Improvement in Stool Frequency, ITT Population, Week 6|0=Normal stool frequency per day, 1=1-2 stools greater than normal per day, 2=3-4 stools greater than normal per day, 3=5 or more stools greater than normal per day|6 Weeks|ITT Patients with Moderate Disease [PGA=2] at Baseline||Percentage of Participants|||Number
702430|NCT00073021|Secondary|Percentage of Patients Whose Sigmoidoscopy Score Improved From Baseline to Week 6, ITT Population|Sigmoidoscopy Assessment Score (0=normal intact vascular pattern, no friability or granularity, 1=mild erythema; diminished or absent vascular markings; mild granularity; friability, 2=moderate marked erythema, granularity; absent vascular markings; bleeds with minimal trauma; no ulcerations, 3=severe spontaneous bleeding, ulcerations)|6 Weeks|ITT Population with Moderate Disease [PGA=2] at Baseline||Percentage of Participants|||Number
702431|NCT00073021|Secondary|Percentage of Participants Whose Rectal Bleeding & Sigmoidoscopy Score Both Improved From Baseline to Week 6, ITT Population|Rectal Bleeding - 0=no blood seen, 1=streaks of blood w/stool less than half of the time, 2=obvious blood w/stool most of the time, 3=blood alone passed Sigmoidoscopy Assessment Score - 0=normal (intact vascular pattern, no friability or granularity), 1=mild (erythema, diminished or absent vascular markings; mild granularity; friability), 2=moderate (marked erythema, granularity; absent vascular markings; bleeds with minimal trauma; no ulcerations) 3=severe (spontaneous bleeding, ulcerations)|6 Weeks|ITT Patients with Moderate Disease [PGA=2] at Baseline. Percentage of patients whose rectal bleeding AND sigmoidoscopy scores BOTH improved from baseline at Week 6||Percentage of Participants|||Number
702432|NCT00073021|Secondary|Change From Baseline in Ulcerative Colitis Disease Activity Index (UCDAI) at Week 6, ITT Population|UCDAI - sum of clinical assessment scores (stool frequency score [0=normal, 1=1-2 stools > normal/day, 2=3-4 stools > normal/day, 3=5 or more stools > normal/day], rectal bleeding score [0=no blood seen, 1=streaks of blood with stool less than half of the time, 2=obvious blood with stool most of the time, 3=blood alone passed and PGA score [0=quiescent disease, 1=mild, 2=moderate, 3=severe]) and sigmoidoscopy score [0=normal, 1=mild, 2=moderate, 3=severe]|6 weeks|ITT Population with Moderate Disease [PGA = 2] at Baseline.||Scores on a Scale||Standard Error|Mean
702433|NCT00073021|Primary|Percentage of Treatment Success Patients at Week 6, ITT (Intent to Treat) Population|Treatment success defined as complete response (PGA score 0 and complete resolution of stool frequency, rectal bleeding, PFA (patient's functional assessment), normal sigmoidoscopy) or partial response (improvement from baseline PGA and improvement in 1 clinical assessment [stool frequency, rectal bleeding, PFA, sigmoidoscopy] and no worsening in any other clinical assessments)|6 Weeks|ITT Population with Moderate Disease [PGA = 2] at Baseline||Percentage of Participants|||Number
702442|NCT00080899|Secondary|Time to PSA Progression|Was summarized using the product-limit (Kaplan-Meier) method. In patients whose PSA levels initially decreased, PSA progression was defined as a 25% increase over the nadir (postenrollment PSA value up to that point), and an increase in the absolute value in the PSA value of 5 ng/mL, relative to the lowest postenrollment PSA value up to that point, including the baseline PSA level – and which was confirmed by second value 3-4 weeks later. A best response of PSA-PD was recorded for those patients who did not achieve a confirmed PSA-N or PSA-PR and who experienced PSA progression within 3 months of start of treatment.|From the start of treatment until the date of the first documentation of PSA progression, assessed up to 5 years|||months||95% Confidence Interval|Mean
702443|NCT00080899|Primary|PSA Response|PSA normalization (PSA-N) was recorded as the best PSA response when a PSA level was undetectable (< 0.1 ng/ml), and was then subsequently confirmed by a second measurement ≥ 4 weeks later. PSA partial response (PSA-PR) was recorded if the PSA decreased by ≥ 50% from pre-treatment or baseline values and was confirmed by a second measurement made ≥ 4 weeks later. Response = PSA-N + PSA-PR.|Baseline to 5 years|||participants|||Number
702444|NCT00080912|Primary|Pain Relief Measured by the Brief Pain Inventory at 2 Months After Treatment|The primary endpoint of this study is Overall Response Rate (complete response and partial response) at two months after the first fraction of re-irradiation; patients with a third radiation treatment (the second re-irradiation) before month two will not have response attributed to the study treatment.|2 months|Intend to treat (ITT) population||percentage of response||95% Confidence Interval|Number
702445|NCT00080938|Secondary|Overall Survival Time|Overall survival (months) was calculated from time of protocol entry to time of death from any cause. Patients alive at last follow-up were censored. The 21 eligible and treated patients were included in the analysis.|assessed every 3 months for 2 years|Eligible and treated patients||months||95% Confidence Interval|Median
702446|NCT00080938|Secondary|Time to Non-CNS (Systemic) Progression|Time to non-CNS progression was calculated from time of protocol entry to time of first systemic progressive disease or death. Patients alive and non-CNS progression-free at last follow-up were censored. Disease progression was defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter (per RECIST criteria). Development of new lesions in non-CNS sites also constituted non-CNS progression. The 21 eligible and treated patients were included in the analysis.|assessed every 3 months for 2 years|Eligible and treated patients||months||95% Confidence Interval|Median
702447|NCT00080938|Secondary|1-year Neurologic (Central Nervous System, CNS) Progression Free Rate|1-year CNS progression free rate is the percentage of patients who had no CNS progression after being followed for 1 year . Progressive disease (CNS) was defined as a 25% or greater increase in the sum of the product(s) of the maximal cross-sections on MRI scan, reappearance of any lesion that has disappeared, development of any new lesion(s), stable disease with a deterioration of neurologic exam, or clear worsening of any evaluable disease.|assessed every 3 months for 2 years|Eligible, treated patients||percentage of participants||95% Confidence Interval|Number
702448|NCT00080938|Primary|Number of Patients With Intracranial Response|Response was assessed per Response Evaluation Criteria in Solid Tumor (RECIST) by brain MRI in the 21 eligible and treated patients.Complete response (CR): complete disappearance of the clinically detectable malignant brain metastasis(es) being followed on MRI scan off corticosteroids and a stable or improving neurologic exam. Partial response (PR): greater than or equal to a 50% reduction in the sum of the product(s) of the maximal cross-sections on MRI scan with a stable or decreasing dose of corticosteroids and a stable or improving neurologic exam. Response = CR + PR|assessed every cycle while on treatment, then every 3 months for 2 years|Eligible and treated patients||participants|||Number
702449|NCT00081497|Secondary|Proteinuria at Pre-Fabrazyme and 6, 12, and 18 Months|Pre-Fabrazyme=baseline visit of AGAL-008-00 (NCT00074984) for Fabrazyme patients; assessment prior to open-label for placebo patients who transitioned to Fabrazyme in AGAL-008-00 (NCT00074984); assessment prior to first Fabrazyme infusion in AGAL02503 (NCT00081497) for placebo patients who did not transition to Fabrazyme in AGAL-008-00 (NCT00074984).|Pre-Fabrazyme and 6, 12, and 18 months|ITT population–62 patients had assessments at 6 months, 61 patients had assessments at 12 months, and 54 patients had assessments at 18 months in the open-label extension study.||urine protein(mg/dL) / creatinine(mg/dL)||Standard Deviation|Mean
702466|NCT00081731|Primary|Cardiovascular or Renal Death||Measured at every 3 months for the first year and annually thereafter|||participants|||Number
702450|NCT00081497|Secondary|Plasma Globotriaosylceramide (GL-3) (Normal Plasma GL-3 Level is ≤ 7.03 µg/mL) at Pre-Fabrazyme and 6, 12, and 18 Months|Pre-Fabrazyme=baseline visit of AGAL00800 for Fabrazyme patients; assessment prior to open-label for placebo patients who transitioned to Fabrazyme in AGAL00800; assessment prior to first Fabrazyme infusion in AGAL02503 for placebo patients who did not transition to Fabrazyme in AGAL00800.|Pre-Fabrazyme and 6, 12, and 18 months|ITT population–64 patients had assessments at 6 and 18 months while 65 patients had assessments at 12 months in the open-label extension study.||µg/mL||Standard Deviation|Mean
702451|NCT00081497|Secondary|Estimated Glomerular Filtration Rate (eGFR) at Pre-Fabrazyme and 6, 12, and 18 Months|Pre-Fabrazyme=baseline visit of AGAL-00-800 (NCT00074984) for Fabrazyme patients; assessment prior to open-label for placebo patients who transitioned to Fabrazyme in AGAL-008-00 (NCT00074984); assessment prior to first Fabrazyme infusion in AGAL02503 (NCT00081497) for placebo patients who did not transition to Fabrazyme in AGAL-008-00 (NCT00074984).|Pre-Fabrazyme, 6, 12, and 18 months|ITT population–67 patients had assessments at 6 and 12 months while 65 patients had assessments at 18 months in the open-label extension study.||ml/min/1.73m^2||Standard Deviation|Mean
702452|NCT00081497|Secondary|Serum Creatinine at Pre-Fabrazyme and 6, 12, and 18 Months|Pre-Fabrazyme=baseline visit of AGAL-008-00 (NCT00074984) for Fabrazyme patients; assessment prior to open-label for placebo patients who transitioned to Fabrazyme in AGAL-008-00 (NCT00074984); assessment prior to first Fabrazyme infusion in AGAL02503 (NCT00081497) for placebo patients who did not transition to Fabrazyme in AGAL-008-00 (NCT00074984).|Pre-Fabrazyme, 6, 12, and 18 months|ITT population–67 patients had assessments at 6 and 12 months while 65 patients had assessments at 18 months in the open-label extension study.||mg/dL||Standard Deviation|Mean
702453|NCT00081497|Post-Hoc|Differences in Slopes of Estimated Glomerular Filtration Rate (eGFR) Comparing Randomized Placebo vs Fabrazyme Patients (Based on the Original Randomization in AGAL-008-00 (NCT00074984)) by Baseline eGFR Subgroups of >60 and ≤60 mL/Min/1.73 m^2.|Summary of differences in slopes of eGFR comparing randomized placebo vs Fabrazyme patients by baseline eGFR subgroups. Differences in slopes are the placebo slope minus the Fabrazyme slope. Therefore, a negative difference indicates a greater decline in the placebo patients relative to the Fabrazyme patients.|Throughout study; 18 months|ITT population. For subgroup Estimated Glomerular Filtration Rate (eGFR) >60, there were 9 placebo patients and 15 Fabrazyme patients. For subgroup eGFR ≤60, there were 19 placebo patients and 24 Fabrazyme patients. For randomized Fabrazyme patients, both the double-blind and open-label data was used.||mL/min/1.73m^2/year||Standard Error|Least Squares Mean
702454|NCT00081497|Primary|Difference in Inverse Serum Creatinine Within Patients' Slopes Between the Placebo AGAL-008-00 (NCT00074984) and Fabrazyme AGAL02503 (NCT00081497) Periods|The primary efficacy analysis was the summary of change in slope of inverse serum creatinine for Placebo/Fabrazyme patients in the Intent to Treat (ITT) Population. It compared the placebo period slope with the Fabrazyme period slope.|Placebo period AGAL-008-00 (up to 35 months) through Fabrazyme period AGAL02503 (18 months)|ITT Population - Analysis compares results during the placebo period with those during the Fabrazyme period and includes only the 28 patients who were randomized to placebo in the AGAL-008-00 (NCT00074984) study; as such no formal sample size calculations were performed.||dL/mg/year||Standard Error|Least Squares Mean
702455|NCT00081653|Secondary|Relative Percent Change From Baseline of Trough Serum CTX|CTX is a measure of bone resorption and is measured as nanograms per milliliter (ng/mL). Blood samples for the Month 6 values were collected 6 days after the 6-month dose; therefore, the Month 6 values are not true 'trough' values.|Baseline, 6,12, 24 and 36 months|ITT population; n = number of participants analyzed for the given parameter at the specified visit.||percent change||Standard Deviation|Mean
702456|NCT00081653|Primary|Relative Percent (%) Change From Baseline in Mean Lumbar Spine (L2 - L4) Bone Mineral Density (BMD)|BMD was measured by a single dual-energy X-ray absorptiometry (DXA) scan of the lumbar spine (BMD of at least 2 vertebrae [L2-L4] that were not fractured and not affected by osteoarthritis to such a degree that BMD measurement would be compromised) at the time of enrollment and at Months 12, 24 and 36. This was baseline of Study MA17903 after two years of treatment in the core study (BM16549 [NCT00081653]).|Baseline and Months 12, 24 and 36|ITT population: n = number of participants analyzed for the given parameter at the specified visit.||percent change||Standard Deviation|Mean
702457|NCT00081653|Primary|Absolute Change From Baseline in Mean Lumbar Spine (L2 - L4) BMD|Absolute change from Baseline in mean BMD of the lumbar spine (L2 - L4) measured as grams per square centimeter (g/cm^2). This was baseline of Study MA17903 after two years of treatment in the core study (BM16549 [NCT00081653]).|Baseline and Months 12, 24 and 36|ITT population; number (n) equals (=) number of participants analyzed at the specified visit.||g/cm^2||Standard Deviation|Mean
702458|NCT00081653|Secondary|Absolute Change From Baseline of Trough Serum CTX|CTX is a measure of bone resorption and is measured as ng/mL. Blood samples for the Month 6 values were collected 6 days after the 6-month dose; therefore, the Month 6 values are not true 'trough' values.|Baseline, 6, 12, 24 and 36 months|ITT population; n = number of participants analyzed for the given parameter at the specified visit.||ng/mL||Standard Deviation|Mean
702459|NCT00081653|Secondary|Relative Percent Change From Baseline in Mean Total Hip BMD|BMD was measured by a single DXA scan of the hip. Scores between -1 and -2.5 indicate Osteopenia (thin bones). Less than -2.5 indicate Osteoporosis (porous bones).|Baseline, 12, 24 and 36 months|ITT Population; n = number of participants analyzed for the given parameter at the specified visit.||percent change in BMD||Standard Deviation|Mean
702460|NCT00081653|Secondary|Absolute Change From Baseline in Mean Total Hip BMD|BMD was measured by a single DXA scan of the hip. Scores between -1 and -2.5 indicate Osteopenia (thin bones). Less than -2.5 indicate Osteoporosis (porous bones).|Baseline and 12, 24 and 36 months|ITT Population; n = number of participants analyzed for the given parameter at the specified visit.||g/cm^2||Standard Deviation|Mean
702461|NCT00081731|Primary|Need for Renal Replacement Therapy||Measured at every 3 months for the first year and annually thereafter|||participants|||Number
702462|NCT00081731|Primary|30% Reduction of eGFR From Baseline, Persisting for Greater Than or Equal to 60 Days||Measured at every 3 months for the first year and annually thereafter|||participants|||Number
702463|NCT00081731|Primary|Stroke||Measured at every 3 months for the first year and annually thereafter|||participants|||Number
702464|NCT00081731|Primary|Hospitalization for Congestive Heart Failure||Measured at every 3 months for the first year and annually thereafter|||participants|||Number
702465|NCT00081731|Primary|Myocardial Infarction||Measured at every 3 months for the first year and annually thereafter|||participants|||Number
702468|NCT00081770|Secondary|Mean Change From Baseline in the Log Viral Load at Treatment Week 2|The difference between viral load levels in the blood at the start of the study and Treatment Week 2, expressed in terms of a logarithmic scale with base 10, and averaged for all the participants in each treatment group.|Assessed at Baseline and Treatment Week 2|ITT Population defined as subjects who received at least one dose of study medication||Log10 IU/mL||Standard Deviation|Mean
702469|NCT00081770|Secondary|Virologic Response Rate at Treatment Week 12|Percentage of participants with undetectable hepatitis C RNA (HCV-RNA) at Treatment Week 12|Assessed at Treatment Week 12|ITT Population defined as subjects who received at least one dose of study medication||Percentage of participants|||Number
702470|NCT00081770|Secondary|Mean Change From Baseline in the Log Viral Load at Treatment Week 4|The difference between viral load levels in the blood at the start of the study and Treatment Week 4, expressed in terms of a logarithmic scale with base 10, and averaged for all the participants in each treatment group.|Assessed at Baseline and Treatment Week 4|ITT Population defined as subjects who received at least one dose of study medication||Log10 IU/mL||Standard Deviation|Mean
702471|NCT00081770|Primary|Sustained Virologic Response (SVR) Rate|SVR rate is the percentage of participants with undetectable hepatitis C virus ribonucleic acid (HCV-RNA) at the end of the 24-week post-treatment follow-up.|Assessed at the end of a 24-week post-treatment follow-up|Intent-to-Treat [ITT] Population defined as subjects who received at least one dose of study medication||Percentage of participants|||Number
702472|NCT00081861|Primary|Number of Participants With Response (Complete Response or Progressive Disease)|Response criteria according to the International Working Group Recommendations for lymphoma where Complete Response (CR) defined as “complete disappearance” of clinically detectable disease and Progressive Disease defined by disease appearance by complete blood count (CBC), clinical and radiologic findings, and/or sizes of lymph nodes, spleen, and liver. Response measured from first documentation of response to first detection of progression.|After 8 weeks of therapy (4 doses of Avastin and 8 doses of Rituximab),|Two participants received first treatment dose but were not eligible for response.||Participants|||Number
702474|NCT00082017|Other Pre-specified|Effect of UCN-01 on Anaplastic Lymphoma Kinase (ALK) Expression in ALCL|Gene expression patterns in participants ALK positive tumors will be assessed.|Day 3-5 after drug administration|This outcome measure was not done because data were insufficient to assess for possible effects of UCN-01 on ALK expression.|||||
702475|NCT00082017|Other Pre-specified|Evaluation of Mature T-cell Lymphoma Cells by Complementary Double-Stranded Deoxyribonucleic Acid (cDNA) Microarray|Mature T-cells will be analyzed to identify gene expression changes that correlate with loss of a tumor suppressor gene in a human melanoma cell line.|Day 3-5 after drug administration|This outcome measure was not done because there were inadequate samples to evaluate mature T cell lymphoma malignant cells by cDNA microarray.|||||
702476|NCT00082017|Other Pre-specified|Effect of UCN-01 on Soluble TAC Cluster of Differentiation 25 (CD25)|Soluble TAC (CD25) levels will be assessed in patients with anaplastic large cell lymphoma.|Day 3-5 after drug administration|This outcome measure was not done because data were insufficient to assess for possible effects on soluble TAC (CD25) levels.|||||
702477|NCT00082017|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|76 months|||Participants|||Number
702478|NCT00082017|Primary|Overall Survival (OS)|OS is defined as the date of on-study to the date of death from any cause or last follow up.|55 months|||months||95% Confidence Interval|Median
702479|NCT00082017|Primary|Progression Free Survival (PFS)|PFS is defined as the time interval from start of treatment to documented evidence of disease progression. Disease progression is assessed by the International Workshop to Standardize Response Criteria for non-Hodgkin's Lymphomas and is defined as a ≥50% increase from nadir in the sum of the products of the greatest diameters of any previously identified abnormal node for partial response's or non-responders or appearance of any new lesion during or at the end of therapy.|3.6 months|||months||95% Confidence Interval|Median
702480|NCT00082017|Primary|Clinical Response Rate|Clinical Response Rate is the percentage of participants with a response assessed by the International Workshop to Standardize Response Criteria. Complete response (CR) is complete disappearance of all detectable clinical and radiographic evidence of disease. Complete response unconfirmed (CRu) is per CR criteria except that if a residual node is >1.5cm, it must have regressed by >75%. Partial response (PR) is no increase in size of nodes, liver or spleen. Progressive disease (PD) is a greater than or equal to 50% increase from nadir. Details re: response criteria, see the protocol link module|74.5 months|||Percentage of participants|||Number
702481|NCT00082173|Secondary|Proportion of Patients With Grade 3 or 4 Adverse Reactions Attributable to Study Medications|Proportion of patients with Grade 3 or 4 adverse reactions attributable to study medications|8 weeks|DAIDS Table of Adverse Events||Participants|||Number
702482|NCT00082173|Primary|Proportion of Patients With Sterile Sputum Cultures|Proportion of patients with sterile sputum cultures|8 weeks|Proportion of patients with sterile sputum cultures at week 8||Participants|||Number
702483|NCT00082329|Secondary|To Examine 1) the Cellular Content and Other Immune Properties of Mobilized Cells; 2) Yields of Hematopoietic Progenitor Cells, Immune Cells, and Other Cellular Subsets Collected by Apheresis; and 3) Safety Profile of AMD3100.||Through day 7||||||
702484|NCT00082329|Primary|To Determine the Cytokine Polarization Status of Cluster of Differentiation 4 (CD4)+ T-cells Collected by Apheresis Following Combination of AMD3100 and G-CSF Compared to G-CSF Mobilization.|"Healthy volunteers will be administered AMD 3100 (Mozobil plerixafor) and granulocyte colony stimulating factor (G-CSF) to determine cytokine polarization status of cluster of differentiation (CD 4) T-cells collected by apheresis
We propose that the combination of single dose AMD 3100 and G-CSF as combined mobilizing agents will improve the peripheral blood progenitor cells mobilization as compared to G-CSF mobilization. The successful treatment responders will complete study treatment with cell mobilization and cell collection. Non-responders will have completed the study treatment and have cell mobilization without cell collection."|Day 1 (cells are counted 24 hours after AMD3100)|||participants|||Number
702485|NCT00082342|Secondary|Bradykinesia Measure Before and After Real and Sham tDCS.|Bradykinesia refers to the slowness in executing a movement. Bradykinesia was assessed by measuring the time in seconds it takes to do the following sequence, 10 times: 1) hand closing and opening while squeezing a ball 2) elbow flexion 3) hand closing and opening, and 4) elbow extension. Subjects were allowed to practice these hand and arm movements until performance appeared not to get faster, and then were abstained from further practice to minimize learning effects. The time it takes subjects to execute the entire sequence 10 times with either the left or right arm/hand was measured. Means are reported for each group.|baseline, 1 day post, 1 month post, 3 months post tDCS|||seconds||Standard Deviation|Mean
702486|NCT00082342|Secondary|UPDRS Motor Scores Before and After Real tDCS Course and After Sham tDCS Course.|The Motor Unified Parkinson's Disease Rating Scale (UPDRS) includes only the motor assessment of the UPDRS (Part III) and examines speech, facial expression, tremor at rest, action tremor, rigidity, finger taps, hand movements, hand pronation and supination, leg agility, arising from chair, posture, gait, postural stability and body bradykinesia. The scores range from 0 (no motor impairment) to 108 (severe motor impairment). The Motor UPDRS was administred at baseline and at 1 day post, 1 month post, and 3 months post tDCS or sham. Subjects were assessed on medication and off medication.|baseline, 1 day post, 1 month post, and 3 months post real and sham tDCS|||units on a scale||Standard Deviation|Mean
702487|NCT00082342|Secondary|UPDRS Total Scores Before and After Real tDCS Course and After Sham tDCS Course.|The Total Unified Parkinson's Disease Rating Scale (UPDRS) is an overall clinical rating scale that quantifies the signs and symptoms of Parkinson's disease. The total UPDRS score was obtained from subject examination, subject interviews and questionnaires. The UPDRS encompasses measurement of mentation, behavior, mood, activities of daily living and motor skills. The total UPDRS scores ranges from 0 (not affected) to 176 (most severely affected). The UPDRS was administred at baseline and at 1 day post, 1 month post, and 3 months post tDCS or sham, while on medication and off medication.|baseline, 1 day post, 1 month post, 3 months post-tDCS|||units on a scale||Standard Deviation|Mean
702488|NCT00082342|Primary|Gait Speed Before and After Real and Sham tDCS.|Gait speed was measured by the time it took the subject to walk 10m. Subjects were instructed to walk at a fast pace without taking the risk of falling, wearing the same shoes and using assistive devices consistently if needed. Gait speed was measured at baseline and post-tDCS.|baseline, 1 day post, 1 month post, 3 months post-tDCS|Intent to treat||Seconds||Standard Deviation|Mean
702489|NCT00082355|Secondary|Number of Participants That Developed Hemorrhage|The outcome measures the number of participants who developed hemorrhage after receiving up to 4 days of Alteplase treatment for DVT.|5 days|The number of participants analyzed is an Intent-to-Treat (ITT) population. The accrual target was to analyze outcomes(immediate, at 6 weeks, and at 6months) after treatment of DVT with alteplase in 25 patients. 30 patients were treated but two participants did not complete the study for 6 week and 6 month outcome assessments.||participants|||Number
702490|NCT00082355|Primary|Number of Participants With Restored Venous Function|The outcome measures the ability of Alteplase to lyse acute and subacute deep venous thrombosis (DVT) of the lower extremities and/or pelvis and restore venous function, or blood flow, to these areas. Restored venous function is also known as patency. Patency is measured by venography and ultrasound exams.|6 months|The number of participants analyzed is an Intent-to-Treat (ITT) population. The initial goal was to be able to evaluate outcomes of treatment of DVT with alteplase over a 6 month period in 25 patients. 30 patients were treated but two participants did not complete the study before being assessed for this outcome measure.||participants|||Number
702491|NCT00082368|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|69 months|||participants|||Number
702492|NCT00082368|Primary|Percent Change in Tc-94m Sestamibi Body Weight Standardized Uptake Value (SUV) Maximum in Tumor Tissue Before and After Administration of Tariquidar, a P-glycoprotein Antagonist.|Sestamibi is a Pgp substrate that may be a surrogate for measuring drug efflux from tumors. Significant increase in the SUV in tumor is +25% over baseline.|3 days|||% change in Tc-94m Sestamibi SUVmax||Full Range|Mean
702493|NCT00082381|Secondary|Change in Rate of Hypoglycemic Events|Change in rate of hypoglycemic events per 30 days per patient from baseline to week 26|Baseline, week 26|Intent to Treat||events per 30 days per patient||Standard Error|Least Squares Mean
702494|NCT00082381|Secondary|Percentage of Patients With Hypoglycemic Events|Percentage of patients who experienced at least one episode of hypoglycemia at any point during the 26 week Parent Study (incidence of hypoglycemia = number of patients who experienced at least one episode of hypoglycemia at any point during the 26 week Parent Study divided by the total number of patients who participated in the 26 week Parent Study|26 weeks|Intent to Treat||percentage of participants|||Number
702495|NCT00082381|Secondary|Change in 7-point Self-monitored Blood Glucose (SMBG) Profile|Change in 7-point (pre-breakfast, 2 hour post breakfast, pre-lunch, 2 hour post lunch, pre-dinner, 2 hour post dinner, 0300 hours) SMBG profile from baseline to week 26|Baseline, week 26|Last Observation Carried Forward; Intent to Treat||mmol/L||Standard Error|Least Squares Mean
702496|NCT00082381|Secondary|Change in Fasting Serum Glucose|Change in fasting serum glucose from baseline to week 26|Baseline, week 26|Last Observation Carried Forward; Intent to Treat||mmol/L||Standard Error|Least Squares Mean
702497|NCT00082381|Secondary|Change in Body Weight|Change in body weight from baseline to week 26|Baseline, week 26|Intent to Treat||kg||Standard Error|Least Squares Mean
702498|NCT00082381|Secondary|Percentage of Patients Achieving HbA1c <=7%|Percentage of patients in each arm who had HbA1c >7% at baseline and had HbA1c <=7% at week 26 (percentage = [number of subjects with HbA1c <=7% at week 26 divided by number of subjects with HbA1c >7% at baseline] * 100%).|26 weeks|Last Observation Carried Forward; Intent to Treat||percentage of participants|||Number
702499|NCT00082381|Primary|Change in Glycosylated Hemoglobin (HbA1c)|Change in HbA1c from baseline to week 26|Baseline, week 26|Last Observation Carried Forward; Intent to Treat, computed from the patients having both baseline and post baseline data||percentage||Standard Error|Least Squares Mean
702500|NCT00082407|Secondary|Change in Rate of Hypoglycemic Events|Change in rate of hypoglycemic events per 30 days per patient from baseline to week 52|baseline, week 52|Last Observation Carried Forward; Intent to Treat||events per 30 days per patient||Standard Error|Least Squares Mean
707355|NCT00122369|Primary|Pain Ratings at Specified Time Point During the Procedure|Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain|50 min|Patients remaining on procedure table||units on a scale||Inter-Quartile Range|Median
702501|NCT00082407|Secondary|Percentage of Patients With Hypoglycemic Events|Percentage of patients who experienced at least one episode of hypoglycemia at any point during the 52 week Parent Study (incidence of hypoglycemia = number of patients who experienced at least one episode of hypoglycemia at any point during the 52 week Parent Study divided by the total number of patients who particiapted in the 52 week Parent Study|52 weeks|Intent to Treat||percentage of participants|||Number
702502|NCT00082407|Secondary|Change in 7-point Self-monitored Blood Glucose (SMBG) Profile|Change in 7-point (pre-breakfast, after breakfast, pre-lunch, after lunch, pre-dinner, after dinner, 0300 hours) SMBG profile from baseline to week 52|baseline, week 52|Last Observation Carried Forward; Intent to Treat||mmol/L||Standard Deviation|Mean
702503|NCT00082407|Secondary|Change in Fasting Serum Glucose|Change in fasting serum glucose from baseline to week 52|baseline, week 52|Intent to Treat, computed from the patients having both baseline and week 52 data.||mmol/L||Standard Error|Least Squares Mean
702504|NCT00082407|Secondary|Change in Body Weight|Change in body weight from baseline to week 52.|baseline, week 52|Intent to Treat, computed from the patients having both baseline and week 52 data.||kg||Standard Error|Least Squares Mean
702505|NCT00082407|Secondary|Percentage of Patients Achieving HbA1c <=7%|Percentage of patients in each arm who had HbA1c >7% at baseline and had HbA1c <=7% at week 52 (percentage = [number of subjects with HbA1c <=7% at week 52 divided by number of subjects with HbA1c >7% at baseline] * 100%).|52 weeks|Last Observation Carried Forward; Intent to Treat||percentage of participants|||Number
702506|NCT00082407|Primary|Change in Glcosylated Hemoglobin (HbA1c)|Change in HbA1c from baseline to week 52|baseline, week 52|Last Observation Carried Forward; Intent to Treat, computed from the patients having both baseline and post-baseline data.||percentage||Standard Error|Least Squares Mean
702507|NCT00082433|Primary|Overall Survival (OS)|Overall survival was defined as the time in months from randomization until the date of death. For those patients who had not died, survival duration was censored at the last date the patient was known to be alive. Median OS with 95% CI estimated using the Kaplan-Meier Product Limit Method.|from date of randomization until death|Analysis was conducted on all randomized patients on an intent to treat basis. This study required at least 846 events (deaths) to ensure the 2-sided, α = 0.05 level, log-rank test to have 90% power to show a statistically significant difference in OS between treatment groups when the hazard ratio (HR) is 0.8.||months||95% Confidence Interval|Median
702508|NCT00082433|Secondary|Symptom Assessment Score Changes From Baseline for Functional Assessment of Cancer Therapy-Breast Symptom Index (FBSI)|Quality of life, as measured by the FBSI, an 8-item, participant-reported instrument to measure symptoms. Each item has 5 possible responses ranging from 0 (not at all) to 4 (very much). The scoring was conducted according to the Functional Assessment of Chronic Illness Therapy manual, Version 4; higher scores reflect fewer symptoms.|Baseline and prior to each 21-day cycle of treatment, and at first posttreatment follow-up assessment|Analysis was conducted on all randomized participants on an intent to treat basis. (Note: while table only reports data up to 24 wks, which represents most results, statistical analysis includes ALL assessments through study and follow-up; a few participants were assessed after more than 100 weeks.)||units on a scale||95% Confidence Interval|Mean
702509|NCT00082433|Secondary|Treatment-Related Safety Summary|Laboratory values, adverse events, and other symptoms were graded using the National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTC) Version 3.0|safety was assessed on a continual basis every cycle while on-treatment and every 4 weeks post treatment until toxicities resolved or were deemed irreversible.|All patients who received at least 1 dose of ixabepilone and/or capecitabine. Participants with baseline hepatic impairment (combination arm, n = 50; capecitabine arm, n = 37), defined as Grade ≥2 AST, ALT or Grade ≥1 total bilirubin, were contraindicated due to disproportionate number of toxic deaths observed in study CA163-046.||Participants|||Number
702510|NCT00082433|Secondary|Time to Response|"Time to response was defined as the time from the first dose of study therapy until measurement criteria were first met for partial or complete (whichever status was recorded first) per RECIST criteria (a 4-item scale described in the previous outcome measure)."|every 6 weeks (± 3 days) from randomization while on treatment until documented progression|Response-evaluable participants (all treated patients with the correct diagnosis of adenocarcinoma originating in the breast who had measurable disease as determined at baseline)||weeks||Full Range|Median
702511|NCT00082433|Secondary|Duration of Response|"Measured from the time RECIST criteria (described in previous outcome measure) were first met for complete or partial response until first date of documented disease progression or death. Patients who neither relapsed nor died were censored on the date of last tumor assessment. Median w/ 95% CI estimated using Kaplan Meier Product Limit Method."|every 6 weeks (± 3 days) from randomization while on treatment until documented progression|Response-evaluable participants (all treated patients with the correct diagnosis of adenocarcinoma originating in the breast who had measurable disease as determined at baseline)||Months||95% Confidence Interval|Median
702512|NCT00082433|Secondary|Response Rate (RR)|"RR=number of patients in that group whose best response is partial(30% decrease in the sum of the longest diameter of target lesions) or complete (disappearance of all target lesions), according to the 4-item Response Evaluation Criteria in Solid Tumors (RECIST), divided by the total number of response-evaluable participants"|every 6 weeks (± 3 days) from randomization while on treatment until documented progression|Response-evaluable participants (all treated participants with the correct diagnosis of adenocarcinoma originating in the breast who had measurable disease as determined at baseline).||percentage of participants||95% Confidence Interval|Mean
702513|NCT00082433|Secondary|Progression-Free Survival (PFS)|PFS was defined for each patient as the time in months from randomization to the date of progression. Patients who died without a reported prior progression were considered to have progressed on their date of death. Patients who did not progress or die were censored on the date of their last tumor assessment.|every 6 weeks (± 3 days) from randomization while on treatment until documented progression|All randomized patients with measurable disease as stratified at the time of randomization; n=480 and n=480 for the 2 treatment groups, respectively. Analysis was conducted once 903 progressions or deaths were observed in 960 participants.||months||95% Confidence Interval|Median
702514|NCT00082758|Primary|Number of Responders (Response Rate)|Response rate to hu14.18-Interleukin-2 in 3 separate strata of patients with recurrent or refractory neuroblastoma. Patients will have radiologic (CT/MRI) tumor and urine homovanillic acid (HVA)/vanillylmandelic acid (VMA) measurements. Patients with prior marrow involvement will have marrow assessments. Patients with MIBG+ (iodine-131-meta-iodobenzylguanidine) prior disease will have MIBG scans performed. For CT/MRI lesions, measureable disease is measured by the Response Evaluation Criteria In Solid Tumors (RECIST) from the National Cancer Institute. RECIST (v1.0) for target lesions: Complete Response (CR): Disappearance of all target lesions, Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions.|Up to 30 weeks|Patients were evaluable for inclusion in the analysis of response if eligible, had an event (relapse, PD, death or secondary malignancy) any time after enrollment, or completed at least 2 courses of Irinotecan/Temozolomide therapy. Patients off therapy before completion of 2 courses by choice or toxicity were not evaluable for response analysis.||participants|||Number
702515|NCT00082810|Secondary|Median Overall Survival|The 95% confidence intervals will be used.|From randomization until death or censored at the date of last follow-up, assessed up to 4 years|||months||95% Confidence Interval|Median
702516|NCT00082810|Secondary|Toxicity as Assessed by NCI CTCAE Version 3.0|The frequency of serious (grade 3) or life-threatening (grade 4) adverse events in this study will be compared to published data of fulvestrant and tipifarnib alone.|Up to 4 years||||||
702517|NCT00082810|Secondary|Duration of Response|DOR was defined for responders as the time from the onset of first response to disease progression and for non-responders as zero|Up to 4 years|||months||95% Confidence Interval|Median
702518|NCT00082810|Secondary|Time to Progression (TTP)|TTP was estimated using the Kaplan–Meier method.|From randomization until progression of the disease, assessed up to 4 years|||months||95% Confidence Interval|Median
702519|NCT00082810|Primary|Clinical Benefit Rate (CBR) (CR Rate, PR Rate, and SD)|Number of participants met the definition of Clinical Benefit Rate.Tumor response was assessed every three cycles by CT using RECIST (Response Evaluation Criteria In Solid Tumors) criteria. Per Response Evaluation Criteria in Solid Tumors (RECIST 1.0) for target lesions: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Up to 24 weeks|||participants|||Number
702520|NCT00082888|Secondary|Toxicity|Number of patients that experienced a grade 3 or 4 toxicity (adverse events considered at least possibly related to Tipifarnib) as measured by NCI (National Cancer Institute) CTCAE (Common Terminology Criteria for Adverse Events) v3.0|3/26/2004 - 2/1/2011||||||
702521|NCT00082888|Secondary|Duration of Response|Duration of response is defined for all evaluable patients that have achieved an objective response as the date at which the patient's objective status is first noted to be either a complete response or partial response to the date progression is documented.|up to 2 years||||||
702522|NCT00082888|Secondary|Time to Progression|Time to progression was defined as the number of months from registration to the date of disease progression with patients being progression-free being censored on the date of their last evaluation.|up to 2 years||||||
702523|NCT00082888|Secondary|Overall Survival|Overall survival time was defined as the time from registration to the date of death or last follow-up.|Up to 2 years||||||
702524|NCT00082888|Primary|Proportion of Confirmed Response (Complete Response, Unconfirmed Complete Response, or Partial Response) During the First 6 Courses of Treatment|Confirmed response is at least a 50% decrease in the sum of the products of the greatest diameters (SPD) of the six largest dominant nodes or nodal masses and no increase in the size of other nodes, liver, or spleen and splenic and hepatic nodules must regress by at least 50% in the SPD and no new sites of disease.|During the first 6 cycles of treatment|||Proportion of confirmed responses||95% Confidence Interval|Number
702525|NCT00083122|Secondary|Time to Progression|Time to progression will be estimated using the method of Kaplan-Meier. Progression is defined as having at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Time from registration to the date of progression or last follow-up, assessed up to 3 years|All 40 participants from Group 1 were analyzed. However, due to slow accrual and early closure, Group 2 was not statistically analyzed for this endpoint.||months||95% Confidence Interval|Median
702526|NCT00083122|Secondary|Overall Survival|Will be estimated using the method of Kaplan-Meier.|Time from registration to date of last follow-up or death due to any cause, assessed up to 3 years|All 40 participants in Group 1 were analyzed for this primary endpoint. However, due to the low accrual and early group 2 closure, Group 2 was not statistically evaluated for this endpoint.||months||95% Confidence Interval|Median
702527|NCT00083122|Primary|Proportion of Confirmed Tumor Responses Defined to be Either a Complete Response (CR) or Partial Response (PR)|"A Complete Response (CR) is defined as the disappearance of all target lesions and normalization of tumor biomarkers.
A Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.
A confirmed tumor response is defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 4-6 weeks apart."|24 weeks|All 45 participants were analyzed.||Percentage of Participants|||Number
702536|NCT00083226|Secondary|Progression Free Survival|Time from registration to disease progression or death, whichever occurred earlier. Patients alive and progression-free were censored at last follow up. 36 eligible and treated patients were included in the analysis. The other 2 eligible and treated patients had no disease status information.|assessed every 3 cycles while on treatment. After discontinuing treatment, assessed every 3 months for 2 years and then every 6 months for 1 year.|eligible and treated patients with progression status information||months||95% Confidence Interval|Median
702537|NCT00083226|Secondary|Overall Survival|Overall survival is defined as time from registration to death from any cause. Patients alive were censored at follow up. Analysis was conducted in the 38 eligible and treated patients.|assessed every 3 months for 2 years and then every 6 months for 1 year|eligible and treated||months||95% Confidence Interval|Median
702538|NCT00083226|Primary|Objective Response Rate Measured by Response Evaluation Criteria In Solid Tumors (RECIST)|Tumor response was measured by Response Evaluation Criteria In Solid Tumors (RECIST) v1.0. Objective response rate included complete response (disappearance of all tumor lesions) and partial response (At least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter.).|assessed every 3 cycles while on treatment. After discontinuing treatment, assessed every 3 months for 2 years and then every 6 months for 1 year|eligible and treated patients||percentage of participants||90% Confidence Interval|Number
702539|NCT00083382|Primary|Best Response|"Best response to study treatment as defined by protocol-specific response criteria:
Complete Response (CR) = absence of urine and serum M-components by immunofixation; bone marrow should be adequately cellular (>20%) with <1% monoclonal plasma cells by DNA-clg flow cytometry; serum calcium level must be normal; no new bone lesions nor enlargement of existing lesions; Normalization of serum concentrations of normal immunoglobulins is not required for CR. Partial Response (PR) = Reduction by > 75% in serum myeloma protein production; Decrease in monoclonal marrow plasmacytosis to <5%; Decrease in Bence-Jones proteinuria by >90%; No new lytic bone lesions or soft tissue plasmacytoma.
Treatment Failures/Progressive Disease (PD) = Such patients do not fulfill the above criteria and/or have new lytic lesions (but not compression fractures), hypercalcemia, or other new manifestations of disease."|2 years|||participants|||Number
702540|NCT00083551|Primary|Overall Survival|Overall Survival at six years after initiating protocol therapy|6 Years|||percentage of participants|||Number
702541|NCT00083616|Secondary|Overall Survival|Kaplan-Meier estimate of median time from enrollment to death from any cause. Deaths were recorded during treatment, safety follow-up and long term follow-up.|Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks.|Adjudicated Prior Failures Set, composed of participants confirmed to be eligible by the Independent Eligibility Review Committee (IERC)||months||95% Confidence Interval|Median
702542|NCT00083616|Secondary|Duration of Stable Disease|Kaplan-Meier estimates of the median time from enrollment to the date of first observed disease progression or death due to disease progression among those participants with a best outcome of stable disease. Stable disease (SD): Neither sufficient shrinkage of Index lesions to qualify for partial response nor sufficient increase to qualify for progressive disease (PD) taking as reference the nadir sum of the products of the longest diameters (SPD) since the treatment started and the disappearance of or persistence of one or more non-index lesions not qualifying for PD.|Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks.|Subset of Adjudicated Prior Failures Set, composed of participants confirmed to be eligible by the Independent Eligibility Review Committee (IERC), with a best outcome of stable disease||Weeks||95% Confidence Interval|Median
702543|NCT00083616|Secondary|Time to Treatment Failure|Kaplan-Meier estimate of median time from enrollment to treatment failure, defined as the date the decision was made to end treatment. Participants remaining in the treatment phase at the time of the analysis were censored on their last visit date.|Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks.|Adjudicated Prior Failures Set, composed of participants confirmed to be eligible by the Independent Eligibility Review Committee (IERC)||Weeks||95% Confidence Interval|Median
702544|NCT00083616|Secondary|Time to Disease Progression|Kaplan-Meier estimate of the median time from enrollment to first observed disease progression or death if death was due to disease progression (whichever comes first). Participants who did not progress while on study or died for reasons other than disease progression while on study were censored at their last evaluable disease assessment date.|Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks.|Adjudicated Prior Failures Set, composed of participants confirmed to be eligible by the Independent Eligibility Review Committee (IERC)||Weeks||95% Confidence Interval|Median
702573|NCT00083889|Primary|Progression-Free Survival (PFS), Investigator's Assessment|Progression-free survival = time from randomization to first documentation of objective tumor progression or to death due to any cause, whichever occured first. PFS = first event date minus the date of randomization + 1). On study included treatment plus 28-day follow-up periods.|Day 28 of each 6-week cycle: duration of treatment phase|ITT||weeks||95% Confidence Interval|Median
702545|NCT00083616|Secondary|Progression-free Survival Time|Kaplan-Meier estimate of median time from enrollment to death or first observed disease progression (whichever comes first). Participants who did not progress while on study and did not die while on study were censored at the last evaluable disease assessment date.|Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks.|Adjudicated Prior Failures Set, composed of participants confirmed to be eligible by the Independent Eligibility Review Committee (IERC)||Weeks||95% Confidence Interval|Median
702546|NCT00083616|Secondary|Time to Response|Median time from enrollment to objective tumor response for participants who responded.|Until the data cut-off date of 22 December 2006. Maximum time of follow-up was 128 weeks.|Subset of Adjudicated Prior Failures Set, composed of participants confirmed to be eligible by the Independent Eligibility Review Committee (IERC), who had a confirmed objective tumor response||Weeks||Inter-Quartile Range|Median
702547|NCT00083616|Secondary|Number of Participants With Objective Tumor Response Throughout Study|Confirmed objective tumor response (complete or partial response) based on modified World Health Organization (WHO) criteria, throughout the duration of the study Tumor response was assessed by a central Independent Review Committee (IRC) and confirmation 4 weeks after initial assessment was required. Complete Response (CR): Disappearance of all index and non-index lesions and no new lesions. Partial Response (PR): At least a 50% decrease in the sum of the product of the longest diameters (SPD) of index lesions taking as reference the Baseline SPD, and no new non-index lesions and no “unequivocal progression” of non-index lesions, or, the disappearance of all index lesions and persistence of one or more non-index lesions not qualifying for either CR or Progressive Disease.|Until the data cut-off date of 22 December 2006. Maximum time of follow-up was 128 weeks.|Adjudicated Prior Failures Set, composed of participants confirmed to be eligible by the Independent Eligibility Review Committee (IERC)||Participants|||Number
702548|NCT00083616|Primary|Duration of Response|The time from first objective response to first observed progression of disease or death if the death was due to disease progression (whichever comes first); participants who respond and have not progressed while on study or died for reasons other than disease progression while on study were censored at their last evaluable disease assessment date. Response (complete or partial response) was assessed per modified WHO criteria by the central IRC. Complete Response (CR): Disappearance of all index and non-index lesions and no new lesions. Partial Response (PR): At least a 50% decrease in the sum of the product of the longest diameters (SPD) of index lesions taking as reference the Baseline SPD, and no new non-index lesions and no “unequivocal progression” of non-index lesions, or, the disappearance of all index lesions and persistence of one or more non-index lesions not qualifying for either CR or Progressive Disease.|Until the data cut-off date of 22 December 2006. Maximum time of follow-up was 128 weeks.|Subset of the Adjudicated Prior Failures Set, composed of participants confirmed to be eligible by the Independent Eligibility Review Committee (IERC), who had a confirmed obective tumor response||Weeks||95% Confidence Interval|Median
702549|NCT00083616|Primary|Number of Participants With Objective Tumor Response Through Week 16|Confirmed objective tumor response (complete or partial response) based on modified World Health Organization (WHO) criteria, through week 16. Tumor response was assessed by a central Independent Review Committee (IRC) and confirmation 4 weeks after initial assessment was required. Complete Response (CR): Disappearance of all index and non-index lesions and no new lesions. Partial Response (PR): At least a 50% decrease in the sum of the product of the longest diameters (SPD) of index lesions taking as reference the Baseline SPD, and no new non-index lesions and no “unequivocal progression” of non-index lesions, or, the disappearance of all index lesions and persistence of one or more non-index lesions not qualifying for either CR or Progressive Disease.|16 weeks|Adjudicated Prior Failures Set, composed of participants confirmed to be eligible by the Independent Eligibility Review Committee (IERC)||Participants|||Number
702550|NCT00083720|Primary|Number of Participants With Serious Adverse Events|Reported SAEs per patient were coded according to the corresponding preferred term and system organ class in the Medical Dictionary for Regulatory Activities. The NCI-CTCAE Version 3.0 was used to grade all SAEs. An SAE was any untoward medical occurrence that resulted in death, persistent/significant disability/incapacity, was life threatening, required inpatient hospitalization or caused prolongation of existing hospitalization,congenital anomaly/birth defect, or any important medical event.|A serious adverse event (SAE) was included in the safety analysis if its onset date occurred anytime during cetuximab treatment or up to 30 days after the last dose of cetuximab.|Patients who were enrolled and treated with any quantity of cetuximab constitute the mITT population. Since this trial was a single arm trial, the mITT population used for the efficacy analyses was also used for the safety analyses.||Participants|||Number
702551|NCT00083720|Primary|Number of Participants With Adverse Events|Reported adverse events (AEs) per patient were coded according to the corresponding preferred term and system organ class in the Medical Dictionary for Regulatory Activities dictionary. The National Cancer Insititute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 3.0 was used to grade all AEs. The collection of AEs began at the time the patient received the first cetuximab dose and continued during the study until 30 days after the last dose of cetuximab. All patients who were enrolled and treated with cetuximab were assessed for safety (mITT population, as treated).|An adverse event (AE) was included in the safety analysis if its onset date occurred anytime during cetuximab treatment or up to 30 days after the last dose of cetuximab.|Patients who were enrolled and treated with any quantity of cetuximab constitute the mITT population. Since this trial was a single arm trial, the mITT population used for the efficacy analyses was also used for the safety analyses.||Participants|||Number
702552|NCT00083720|Secondary|Overall Survival|This measure is defined as the time from the first day of therapy to the date of death. Survival of living patients or those lost to follow-up were censored on the last date the patients were known to be alive.|Survival information was collected every 3 months after completion of therapy and/or follow-up up to 24 months.|Overall survival was calculated from the time of the first day of therapy to the date of death for the mITT population.||Months||95% Confidence Interval|Median
702553|NCT00083720|Secondary|Time to Progression|This measure was defined as the time from the first day of treatment until the date of PD. Deaths without objective progression were censored. Patients who did not progress were censored at their last day of tumor assessment.|Patients with PD after receiving at least one standard chemotherapeutic regimen that included a fluoropyrimidine (range: 1-3 months).|This measure was calculated for the mITT population.||Months||95% Confidence Interval|Median
702554|NCT00083720|Secondary|Duration of Response|In patients with a best overall response of CR or PR, the duration of response is measured from the date criteria are first met for CR or PR, until the first date that Progressive Disease (PD) is objectively documented or death occurs. Duration of response of living patients with no evidence of PD was censored on the date of their last tumor assessment.|The duration of response was measured from the date of response to the first date of PD (range 2 to 7 months).|The duration of response was calculated for the subgroup of the mITT population who demonstrated a response.||Months||95% Confidence Interval|Median
702555|NCT00083720|Secondary|Percentage of Participants With Disease Control (CR, PR, or SD)|This is the total number of patients with a best overall response of CR, PR, and stable disease (SD) divided by the total number of patients treated.|Tumor evaluations were performed at a minimum of every 6 weeks while on cetuximab therapy. Patients with a PR or CR had a confirmatory tumor assessment no less than 4 weeks after the initial evaluation demonstrating a response.|Disease control rate was the total number of patients with best overall response of CR, PR and SD divided by the total number of patients treated.||Percentage of participants||95% Confidence Interval|Mean
702556|NCT00083720|Primary|Percentage of Participants With an Overall Resonse|Determine the response rate (complete response [CR] and partial response [PR]) in patients with epidermal growth factor receptor (EGFR)-negative metastatic colorectal carcinoma treated with cetuximab, as classified by the investigator according to the World Health Organization (WHO) criteria. The calculation was the total number of patients with CR or PR divided by the total number of patients treated.|Tumor evaluations were performed at a minimum every 6 weeks while on cetuximab therapy until progressive disease (PD) or recurrence. Patients with a PR or CR had a confirmatory tumor assessment no less than 4 weeks after the initial evaluation.|The overall response rate was calculated for the modified Intent to Treat (mITT) population.||percentage of participants||95% Confidence Interval|Mean
702557|NCT00083759|Secondary|American College of Rheumatology (ACR)70|≥70% reduction from baseline in painful/tender joint count and swollen joint count and ≥70% improvement in at least three of five secondary clinical parameters (e.g., subject global assessment, physician global assessment, pain scale, disability score, and an acute phase reactant)|Month 6|||participants|||Number
702558|NCT00083759|Secondary|American College of Rheumatology (ACR)50|≥50% reduction from baseline in painful/tender joint count and swollen joint count and ≥50% improvement in at least three of five secondary clinical parameters (e.g., subject global assessment, physician global assessment, pain scale, disability score, and an acute phase reactant)|Month 6|||participants|||Number
702559|NCT00083759|Primary|American College of Rheumatology (ACR)20.|≥20% reduction from baseline in painful/tender joint count and swollen joint count and ≥20% improvement in at least three of five secondary clinical parameters (e.g., subject global assessment, physician global assessment, pain scale, disability score, and an acute phase reactant)|Month 6|||participants|||Number
702560|NCT00083889|Secondary|Ctrough Concentrations of SU011248 and Active Metabolite SU012662|Subject observed Ctrough (trough drug) concentrations of total drug (SU011248 and its active metabolite SU012662) per cycle and study day determined by plasma trough samples collected from a subset of patients. Steady-state observed trough concentrations were dose corrected to the starting dose (reference dose) where appropriate. Concentrations below the limits of quantitation (BLQ) were set to 0. Ctrough = minimum (trough) plasma concentration (nanograms per milliliter [ng/mL]).|Day 28 of Cycle 1 to Cycle 4|As treated (AT) population: all patients who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received. Pharmacokinetic (PK) analyses were performed on the AT population who had at least one PK sample. n=number of subjects with evaluable trough samples at observation.||ng/mL||Standard Deviation|Mean
702561|NCT00083889|Secondary|Ctrough Concentrations of Metabolite SU012662|Subject observed Ctrough (trough drug) concentrations of active metabolite SU012662 per cycle and study day determined by plasma trough samples collected from a subset of patients. Steady-state observed trough concentrations were dose corrected to the starting dose (reference dose) where appropriate. Concentrations below the limits of quantitation (BLQ) were set to 0. Ctrough = minimum (trough) plasma concentration (nanograms per milliliter [ng/mL]).|Day 28 of Cycle 1 to Cycle 4|As treated (AT) population: all patients who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received. Pharmacokinetic (PK) analyses were performed on the AT population who had at least one PK sample. n=number of subjects with evaluable trough samples||ng/mL||Standard Deviation|Mean
702562|NCT00083889|Secondary|Ctrough Concentrations of SU011248|Subject observed Ctrough (trough drug) concentrations of SU011248 per cycle and study day determined by plasma trough samples collected from a subset of patients. Steady-state observed trough concentrations were dose corrected to the starting dose (reference dose) where appropriate. Concentrations below the limits of quantitation (BLQ) were set to 0. Ctrough = minimum (trough) plasma concentration (nanograms per milliliter [ng/mL]).|Day 28 of Cycle 1 to Cycle 4|As treated (AT) population: all patients who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received. Pharmacokinetic (PK) analyses were performed on the AT population who had at least one PK sample. n=number of subjects with evaluable trough samples.||ng/mL||Standard Deviation|Mean
702563|NCT00083889|Secondary|Incremental Cost Effectiveness Ratio (ICER)|Incremental cost effectiveness ratio (ICER) of sunitinib compared to IFN-a as first-line treatment for MRCC, defined as the ratio of the incremental cost of treatment over the incremental effectiveness; effectiveness measured as quality adjusted life year (QALY) gain. This objective was not addressed in the clinical study report, but an interim analysis of cost-effectiveness was presented separately. These results were not available for inclusion at the time of this posting.|post study measurement|||ratio|||Number
702574|NCT00083889|Secondary|FACT-Kidney Symptom Index (FKSI) Subscale|FACT-Kidney Symptom Index (FKSI) subscale designed to be a stand-alone instrument to measure symptoms and quality of life in patients with advanced kidney cancer. Contains 15 questions; some questions overlap with the FACT-G questions. Each question was answered on a five-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Total FKSI score = sum score of the 15 item scores; total range: 0 - 60; 0 (most severe symptoms and concerns) to 60 (no symptoms or concerns).|Day 1 & 28 of each cycle: duration of treatment phase|ITT; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation.||scores on scale||Standard Deviation|Mean
702564|NCT00083889|Secondary|Plasma Concentrations of Soluble Proteins: Plasma Basic Fibroblast Growth Factor (bFGF) That May be Associated With Tumor Proliferation or Angiogenesis|Plasma concentrations of soluble proteins that may be associated with tumor proliferation or angiogenesis collected from a subset of patients were analyzed by enzyme-linked immunosorbent assay (ELISA) analysis. Soluble protein values: Baseline concentration (pM) and ratio to Baseline at each timepoint; ratio = plasma concentration of soluble protein (picograms per milliliter [pg/ml]) at timepoint / concentration of soluble protein (pg/ml) at baseline. Samples below the limit of quantitation and samples with insufficient volume available were excluded.|Day 1 & Day 28, Cycle 1 to Cycle 4|Pharmacodynamic analyses performed at selected sites on AT population who had at least one PK (pharmacokinetic) sample; n = subjects with evaluable data at observation, SU011248 and INF-α treatment groups, respectively. Abbreviations: C = Cycle, D = Day, bFGF: basic fibroblast growth factor.||pg/ml and ratio to Baseline||Standard Deviation|Mean
702565|NCT00083889|Secondary|Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis|Plasma concentrations of soluble proteins that may be associated with tumor proliferation or angiogenesis collected from a subset of patients were analyzed by enzyme-linked immunosorbent assay (ELISA) analysis. Soluble protein values: Baseline concentration (pM) and ratio to Baseline at each timepoint; ratio = plasma concentration of soluble protein (picograms per milliliter [pg/ml]) at timepoint / concentration of soluble protein (pg/ml) at baseline. Samples below the limit of quantitation and samples with insufficient volume available were excluded.|Day 1 & Day 28, Cycle 1 to Cycle 4|Pharmacodynamic analyses performed at selected sites on AT population who had at least one pharmacokinetic sample; n= SU011248, INF-α; Abbreviations: C: Cycle, D: Day, VEGF: vascular endothelial growth factor, sVEGFR-3: soluble vascular endothelial growth factor Receptor-3, IL-8: interleukin-8, bFGF: basic fibroblast growth factor.||pg/ml and ratio to Baseline||Standard Deviation|Mean
702566|NCT00083889|Secondary|Euro-QoL Visual Analog Scale (EQ-VAS)|EQ-VAS: overall self-rating rating of the patient’s current health state using a 20 cm Visual Analog Scale (EQ-VAS), also called the health state thermometer) is a metric measurement (in 2 mm interval) from the visual analog scale which ranges between 0 (worse imaginable health state) and 100 (best imaginable health state).|Day 1 & 28 of each cycle: duration of treatment phase|ITT; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation.||scores on scale||Standard Deviation|Mean
702567|NCT00083889|Secondary|EuroQoL Five Dimension (EQ-5D) Health State Index|EQ-5D Health State Index: a brief, self-administered generic health status instrument. Respondents were asked to describe their current health state on each of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety or depression) on a three-level scale (1=no problem, 2=some problem, and 3=extreme problem). A maximum score of 1 can be derived from these 5 dimensions by score conversion; range: –0.39 (worst health state)to 1.00 (best health state). This descriptive system classifies respondents into one of 243 possible distinct health states (EQ-5D descriptive system).|Day 1 & 28 of each cycle: duration of treatment phase|ITT; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation.||scores on scale||Standard Deviation|Mean
702568|NCT00083889|Secondary|Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale|Functional well-being (FWB) subscale of the Functional Assessment of Cancer Therapy-General (FACT-G). Each question was answered on a five-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Score = the sum score of the item scores in the subscale; range: 0 to 28; higher score indicates greater functional well-being.|Day 1 & 28 of each cycle: duration of treatment phase|ITT||scores on scale||Standard Deviation|Mean
702569|NCT00083889|Secondary|Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale|Emotional well-being (EWB)subscale of the Functional Assessment of Cancer Therapy-General (FACT-G). Each question was answered on a five-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Score = the sum score of the item scores in the subscale; range: 0 to 24; lower score indicates better emotional well-being.|Day 1 & 28 of each cycle: duration of treatment phase|ITT; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation.||scores on scale||Standard Deviation|Mean
702570|NCT00083889|Secondary|Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale|Social/family well-being (SWB)subscale of the Functional Assessment of Cancer Therapy-General (FACT-G). Each question was answered on a five-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Score = the sum score of the item scores in the subscale; range: 0 to 28; lower score indicates less social/family well-being.|Day 1 & 28 of each cycle: duration of treatment phase|ITT; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation.||scores on scale||Standard Deviation|Mean
702571|NCT00083889|Secondary|Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale|Physical well-being (PWB) subscale of the Functional Assessment of Cancer Therapy-General (FACT-G). Each question was answered on a five-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Score = the sum score of the item scores in the subscale; range: 0 to 28; lower score indicates better physical well-being.|Day 1 & 28 of each cycle: duration of treatment phase|ITT; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation.||scores on scale||Standard Deviation|Mean
702572|NCT00083889|Secondary|Functional Assessment of Cancer Therapy-General (FACT-G)|Functional Assessment of Cancer Therapy-General (FACT-G): core questionnaire of the Functional Assessment of Chronic Illness Therapy (FACIT) measurement system that has been validated in a variety of cancer populations. 27 questions grouped into 4 domains that measure a patient’s physical, functional, social and family, and emotional well-being. Five-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Score = sum score of item scores in the subscale; total range: 0 to 108 with higher score indicating better quality of life.|Day 1 & 28 of each cycle: duration of treatment phase|ITT; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation.||scores on scale||Standard Deviation|Mean
702587|NCT00084084|Other Pre-specified|Heart Rate Variability - Change From Baseline at Week 185 in SDNN|Heart rate variability was assessed by 2-hour Holter monitoring. Standard deviation of all filtered RR intervals over the length of the analysis (SDNN) was measured.|Week 185|Number of participants present at Visit Week 185 included for analysis.||msec||Standard Deviation|Mean
702575|NCT00083889|Secondary|FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale|FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) subscale of the FKSI to measure advanced kidney cancer disease related symptoms. Includes 9 items: lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, and hematuria. Each question was answered on a five-point Likert-type scale ranging from 0 (not at all) to 4 (very much). Score = the sum score of the item scores in the subscale; total range: 0 to 36. A score greater than 0 indicates the difference favored sunitinib.|Day 1 & 28 of each cycle: duration of treatment phase|ITT; summary of FKSI-DRS questionnaire results by treatment; N=number of subjects with evaluable data; n = number of subjects with evaluable data at observation, SU011248 and INF-α treatment groups, respectively.||scores on scale||Standard Deviation|Mean
702576|NCT00083889|Secondary|Duration of Response (DR), Investigator's Assessment|Duration of response (DR) = time from the first documentation of objective tumor response to the first documentaion of objective tumor progression or to death due to any cause. DR data were censored on the day following the date of the last on treatment (including 28 day follow-up period) tumor assessment documenting absence of progressive disease for subjects without objective tumor progression who did not die due to any cause while on treatment or who were given anti-tumor treatment other than study treatment prior to observing tumor progression.|Day 28 of each cycle: duration of treatment phase|ITT||weeks||95% Confidence Interval|Median
702577|NCT00083889|Secondary|Duration of Response (DR), Core Radiology Assessement|Duration of response (DR) = time from the first documentation of objective tumor response to the first documentation of objective tumor progression or to death due to any cause. DR data were censored on the day following the date of the last on treatment (including 28 day follow-up period) tumor assessment documenting absence of progressive disease for subjects without objective tumor progression who did not die due to any cause while on treatment or who were given anti-tumor treatment other than study treatment prior to observing tumor progression.|Day 28 of each cycle: duraton of treatment phase|ITT||weeks||95% Confidence Interval|Median
702578|NCT00083889|Secondary|Time to Tumor Progression (TTP), Investigator's Assessment|TTP = time from randomization to first documentation of objective tumor progression. TTP data were censored on the day following the date of last on treatment (including 28 day follow-up period) tumor assessment documenting absence of progressive disease for subjects who did not have objective tumor progression while on treatment or who were given anti-tumor treatment other than the study treatment prior to documentation of objective tumor progression. Subjects with no tumor assessments after randomization had TTP censored on the date of randomization with a duration of 1 day.|Randomization to first documentation of tumor progression: duration of treatment phase|ITT||weeks||95% Confidence Interval|Median
702579|NCT00083889|Secondary|Time to Tumor Progression (TTP), Core Radiology Assessment|TTP = time from randomization to first documentation of objective tumor progression. TTP data were censored on the day following the date of last on treatment (including 28 day follow-up period) tumor assessment documenting absence of progressive disease for subjects who did not have objective tumor progression while on treatment or who were given anti-tumor treatment other than study treatment prior to documentation of objective tumor progression. Subjects with no tumor assessments after randomization had TTP censored on the date of randomization with a duration of 1 day.|Randomization to first documentation of tumor progression: duration of treatment phase|ITT||weeks||95% Confidence Interval|Median
702580|NCT00083889|Secondary|Overall Survival (OS)|Overall survival (OS) = time from date of randomization to date of death due to any cause. For patients not expiring, survival time was censored at the last date they were known to be alive. Patients lacking data beyond randomization had their survival times censored at the date of randomization with a duration of 1 day.|Clinic visit or telephone contact every 2 months until death|ITT||weeks||95% Confidence Interval|Median
702581|NCT00083889|Secondary|Objective Response, Investigator's Assessment|Objective response (OR) = the number of patients with confirmed complete response (CR) and confirmed partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, relative to all randomized patients. CR was defined as the disappearance of all target lesions. PR was defined as a ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. Confirmed responses = those that persist on repeat imaging study >= 4 weeks after initial documentation of response.|Day 28 of each 6-week cycle: duration of treatment phase|ITT||participants|||Number
702582|NCT00083889|Secondary|Objective Response, Core Radiology Assessment|Objective response (OR) = the number of patients with confirmed complete response (CR) and confirmed partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, relative to all randomized patients. CR was defined as the disappearance of all target lesions. PR was defined as a ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. Confirmed responses (CR or PR) = those that persisted on repeat imaging study >= 4 weeks after initial documentation of response.|Day 28 of each 6-week cycle: duration of treatment phase|ITT||participants|||Number
702583|NCT00083889|Primary|Progression-Free Survival (PFS), Core Radiology Assessment|Progression-free survival (PFS) = time from randomization to first documentation of objective tumor progression or to death due to any cause, whichever occured first. If tumor progression data included more than 1 date, the first date was used. PFS = first event date minus the date of randomization + 1. On study included treatment plus 28-day follow-up periods.|Day 28 of each 6-week cycle: duration of treatment phase|Intent to treat (ITT) population: all patients who were randomized, with study drug assignment designated according to initial randomization, regardless of whether patients received study drug or received a different drug from that to which they were randomized.||weeks||95% Confidence Interval|Median
702586|NCT00084084|Secondary|Pharmacokinetics - Maximum Observed Serum Concentration (Cmax)|Cmax is the peak plasma concentration of a drug after administration.|341 weeks|||U/mL||Standard Deviation|Mean
702590|NCT00084136|Secondary|Time to First Dose Modification or Grade 3 or 4 Adverse Event (NRTI Comparison)|Time from treatment dispensation to the first occurring of the following: week of first ARV medication change; week of first grade 3 or higher sign/symptom or laboratory abnormality (total bilirubin was excluded) that was at least one grade higher than baseline. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables.|Throughout study follow-up until study closure (May 31, 2010)|Participants never starting meds excluded. Censoring time is scheduled study week of last clinic visit.||weeks||95% Confidence Interval|Number
702591|NCT00084136|Secondary|Time to Loss of Virologic Response at Week 96 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(NRTI Comparison)|Time to any of the following events occurring prior to week 96: changed any ARV medication (including permanent discontinuation of all medications); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression.|Week 96 using follow-up through study closure on May 31,2010|||weeks||95% Confidence Interval|Number
702592|NCT00084136|Secondary|Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(NRTI Comparison)|Time from randomization to any of the following events occurring prior to week 48: changed any ARV medication (including permanent discontinuation of all medications); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression.|Week 48 using follow-up through study closure on May 31,2010|||weeks||95% Confidence Interval|Number
702593|NCT00084136|Secondary|Time to Loss of Virologic Response at Week 96 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(NRTI Comparison)|Time from randomization to any of the following events occurring prior to week 96: discontinued ARV regimen (see time to discontinuation of initial ARV therapy above); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression.|Week 96 (using follow-up through to study closure on May 31,2010)|Substitutions not triggering TLOVR event included the following: stavudine or tenofovir-DF for zidovudine; nevirapine for efavirenz; or didanosine for tenofovir-DF.||weeks||95% Confidence Interval|Number
702594|NCT00084136|Secondary|Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(NRTI Comparison)|Time from randomization to any of the following events occurring prior to week 48: discontinued ARV regimen (see time to discontinuation of initial ARV therapy above); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression.|Week 48 (using follow-up through study closure on May 31,2010)|Substitutions not triggering TLOVR event included the following: stavudine or tenofovir-DF for zidovudine; nevirapine for efavirenz; or didanosine for tenofovir-DF.||weeks||95% Confidence Interval|Number
702595|NCT00084136|Secondary|Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (NRTI Comparison)|Number of participants with plasma HIV-1 Viral load fewer than 400 copies/mL at study visit weeks 24 and 48. Closest observed result between 20 and up to 28 weeks (for week 24), and between 44 and up to 52 (for week 48) used if multiple results available. Missing values excluded, and both study treatment status and history ignored.|At Weeks 24 and 48 (including follow-up through to study closure on May 31, 2010)|ITT (ignoring current treatment status or past treatment history); closest value to week 24 (48) used if multiple values available; missing values ignored.||participants|||Number
702596|NCT00084136|Secondary|Change in CD4 Count From Screening to Weeks 24, 48, 96 (NRTI Comparison)|Available pre-randomization CD4 cell counts were limited to the single CD4 cell count used for study eligibility (and therefore must have been fewer than 300 cells/mm3).|weeks 24, 48 and 96 (including all follow-up through to study closure on May 31, 2010)|ITT - ignoring both current treatment status and treatment history.||cells/mm^3||Inter-Quartile Range|Median
702597|NCT00084136|Secondary|Time to Immunologic Failure (NRTI Comparison)|Time from randomization to the first scheduled study visit (week 48 or later) with a CD4+ cell count fewer than 100 cells/mm3.|At or after Week 48 (including all follow-up through study closure - May 31,2010)|||weeks||95% Confidence Interval|Number
702598|NCT00084136|Secondary|Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (NRTI Comparison)|Time is measured from date of treatment initiation to earliest of the following: date of last participant contact (premature discontinuation of study follow-up); date all ARV medications were held (if all medications held for at least 8 weeks, for any reason); date that any ARV medication was changed (excluding the following single ARV substitutions: stavudine or tenofovir for zidovudine, nevirapine for efavirenz, or didanosine for tenofovir).|Throughout follow-up until study closed (May 31,2010)|Participants not starting study treatment excluded.||weeks||95% Confidence Interval|Number
702599|NCT00084136|Secondary|Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(PI Comparison)|Time from randomization to any of the following events occurring prior to week 48: changed any ARV medication (including permanent discontinuation of all medications); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression.|Week 48 (using follow-up only until closing of ddI+FTV+ATV arm on May 22,2008)|||weeks||95% Confidence Interval|Number
702600|NCT00084136|Secondary|Time to Loss of Virologic Response by Week 48 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(PI Comparison)|Time from randomization to any of the following events occurring prior to week 48: discontinued ARV regimen (see time to discontinuation of initial ARV therapy above); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression.|Week 48 (using follow-up only until closing of ddI+FTV+ATV arm on May 22,2008)|Substitutions not triggering TLOVR event included the following: stavudine or tenofovir-DF for zidovudine; nevirapine for efavirenz; or didanosine for tenofovir-DF.||weeks||95% Confidence Interval|Number
702647|NCT00076999|Secondary|Median Change From Baseline in CD4 Percent at Week 48 (Last Observation Carried Forward)|Percentage of lymphocytes that are CD4 cells|baseline, week 48|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment||percentage of cells||Inter-Quartile Range|Median
702601|NCT00084136|Secondary|Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (PI Comparison)|Number of participants with plasma HIV-1 Viral load fewer than 400 copies/mL at study visit weeks 24 and 48. Closest observed result between 20 and up to 28 weeks (for week 24), and between 44 and up to 52 (for week 48) used if multiple results available. Missing values excluded, and both study treatment status and history ignored.|At Weeks 24 and 48 (including only follow-up until ddI+FTC+ARV arm closed - May 22, 2008)|ITT (ignoring current treatment status or past treatment history); closest value to week 24 (48) used if multiple values available; missing values ignored.||participants|||Number
702602|NCT00084136|Secondary|Time to First Dose Modification or Grade 3 or 4 Adverse Event (PI Comparison)|Time from treatment dispensation to the first occurring of the following: week of first ARV medication change; week of first grade 3 or higher sign/symptom or laboratory abnormality (total bilirubin was excluded) that was at least one grade higher than baseline. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables.|Throughout study follow-up until ddI+FTC+ATV arm closed (May 22, 2008)|Participants never starting meds excluded. Censoring time is scheduled study week of last clinic visit.||weeks||95% Confidence Interval|Number
702603|NCT00084136|Secondary|Change in CD4 Count From Screening to Weeks 24, 48, 96 (PI Comparison)|Available pre-randomization CD4 cell counts were limited to the single CD4 cell count used for study eligibility (and therefore must have been fewer than 300 cells/mm3).|weeks 24, 48 and 96 (including follow-up until ddI+FTC+ARV arm closed - May 22, 2008)|ITT - ignoring both current treatment status and treatment history.||cells/mm^3||Inter-Quartile Range|Median
702604|NCT00084136|Secondary|Time to Immunologic Failure (PI Comparison)|Time from randomization to the first scheduled study visit (week 48 or later) with a CD4+ cell count fewer than 100 cells/mm3.|At or after Week 48 (including only follow-up until ddI+FTV+ATV arm closed - May 22,2008)|ITT (ignoring current study treatment status or history)||weeks||95% Confidence Interval|Number
702605|NCT00084136|Secondary|Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (PI Comparison)|Time is measured from date of treatment initiation to earliest of the following: date of last participant contact (premature discontinuation of study follow-up); date all ARV medications were held (if all medications held for at least 8 weeks, for any reason); date that any ARV medication was changed (excluding the following single ARV substitutions: stavudine or tenofovir for zidovudine, nevirapine for efavirenz, or didanosine for tenofovir).|Throughout follow-up until ddI+FTC+ATV arm closed (May 22,2008)|Participants not starting study treatment excluded.||weeks||95% Confidence Interval|Number
702606|NCT00084136|Primary|Time to Treatment Failure (NRTI Comparison)|Time from randomization to the earliest of: scheduled week of first plasma sample meeting virologic failure (two consecutive plasma HIV-1 RNA values 1,000 copies/mL or higher, regardless of whether ARV medications being taken at the time); scheduled week of first AIDS defining diagnosis (WHO Stage 4 (2005) plus microsporidiosis, cyclospora gastroenteritis and Chaga's disease), not attributed to Immune Reconstitution Inflammatory Syndrome (reviewed by chairs); date of death (due to any cause). Plasma drawn every 8 weeks (except confirmation samples could be drawn earlier).|Virologic failure starting 14 weeks following randomization; disease progression starting 12 weeks following randomization; and death occurring at any time following randomization. Follow-up through study closure (May 31, 2010).|ITT (study treatment status and history ignored); censoring time was latest study visit week where plasma HIV-1 RNA was measured.||weeks||95% Confidence Interval|Number
702607|NCT00084136|Primary|Time to Treatment Failure (PI Comparison)|Time from randomization to the earliest of: scheduled week of first plasma sample meeting virologic failure (two consecutive plasma HIV-1 RNA values 1,000 copies/mL or higher, regardless of whether ARV medications being taken at the time); scheduled week of first AIDS defining diagnosis (WHO Stage 4 (2005), plus microsporidiosis, cyclospora gastroenteritis and Chaga's disease), not attributed to Immune Reconstitution Inflammatory Syndrome (reviewed by chairs); date of death (due to any cause). Plasma drawn every 8 weeks (except confirmation samples could be drawn earlier).|Virologic failure starting 14 weeks following randomization; disease progression starting 12 weeks following randomization; and death occurring at any time following randomization. Follow-up until ddI+FTC+ATV arm closed (May 22, 2008).|ITT (study treatment status and history ignored); censoring time was latest study visit week where plasma HIV-1 RNA was measured.||weeks||95% Confidence Interval|Number
702608|NCT00076258|Primary|Percentage of Participants With Remission (Score of 12 or Less on Inventory for Depressive Symptomatology- Clinician-rated)|The primary outcome measure- percentage of participants with remission (score of 12 or less on Inventory for Depressive Symptomatology- Clinician-rated). The change over time in probability of remission (IDS-C30 score ≤ 12) was compared between groups using a generalized linear mixed model (GLMM)41 as implemented in SAS (Proc Glimmix; SAS Institute Inc, Cary, North Carolina).|12 weeks|||percentage of participants in remission|||Number
702609|NCT00076336|Secondary|Number of Participants With Improvement, Stabilization, and Worsening in a Modified (3-component) CTP Score|Modified CTP was calculated using the 3 biochemical-components (serum bilirubin, albumin, and prothrombin). Total scores range from 3-9; higher scores indicate more liver impairment. Improvement was defined as 2-point or greater reduction in score from baseline. Stabilization comprises a score change of 1-point or less from baseline. Worsening of CTP score was defined as a 2-point or greater increase from baseline. The rationale for assessing changes in this modified (3-component) CTP score is that this maneuver removed the two subjective components of CTP scoring (ascites and encephalopathy).|Baseline and Week 104|"The analysis was done on the intention-to-treat (ITT) population. Last Observation Carried Forward (LOCF) was utilized for missing data, with the exception of missing observations due to treatment failure, death or AE, which were imputed as worsening CTP."||Participants|||Number
702610|NCT00076336|Secondary|Number of Participants With Improvement, Stabilization, and Worsening in Child-Turcotte-Pugh (CTP) Score at Week 52 and Week 104|Child-Turcotte-Pugh (CTP) uses 2 clinical variables, ascites and encephalopathy, and 3 laboratory parameters, serum bilirubin, albumin, and prothrombin time. Each variable is assigned a score from 1 to 3, with the combined score comprising the CTP score range of 5 to 15 points. Higher scores indicate more impaired liver function. “Worsening” of CTP score was defined as a 2-point or greater increase from baseline, “improvement” in CTP score was defined as a 2-point or greater reduction from baseline, and “stabilization” of CTP score was defined as a change of 1-point or less from baseline.|From Baseline to weeks 52 and 104|"The analysis was done per intention-to-treat (ITT) population. Last Observation Carried Forward (LOCF) was utilized for missing data, with the exception of missing observations due to treatment failure, death or AE, which were imputed as worsening CTP."||Participants|||Number
702611|NCT00076336|Secondary|Duration of Initial Clinical Response|Kaplan-Meier method was used. The duration was calculated as: date of last visit before initial loss of clinical response – date of initial clinical response occurred+1. If a patient did not lose clinical response, it was then censored at the efficacy overall censoring date.|Baseline to Week 104|The analysis was on intention-to-treat (ITT) population. Only patients who achieved clinical response were considered.||Days||Standard Error|Mean
702612|NCT00076336|Secondary|Time to Initial Clinical Response|Time to Clinical Response defined as the number of days elapsed from the baseline visit to achieving initial Clinical Response.|From Baseline to Week 104|The analysis was on intention-to-treat (ITT) population. Only the observed time to initial clinical response was summarized.||Days||Standard Deviation|Mean
702613|NCT00076336|Primary|Number of Participants With Clinical Response|Clinical response defined as achieving all of the following 3 criteria on at least 2 consecutive visits or at the last on-treatment visit: Serum hepatitis B virus (HBV) DNA < 4 log10 copies/mL, normal Alanine transaminase (ALT) level (ALT ≤ Upper Limit of Normal (ULN)), and improvement (a 2- point or greater reduction in Child-Turcotte-Pugh (CTP) score) or stabilization (not more than a 1-point change in CTP score), compared to the baseline value. CTP scores range from 5-15, higher scores indicate more liver impairment. For Improvement/Stabilization, either of the individual criteria were met.|From Baseline to Week 52|The analysis was on the intention-to-treat (ITT) population.||Participants|||Number
702614|NCT00076570|Secondary|The Rate of Significant Drug-associated Complications.||3 years|||participants|||Number
702615|NCT00076570|Primary|The Rate of Allograft Rejection||3 years|||participants|||Number
702616|NCT00076687|Secondary|Change From Baseline in Ashworth Scale|Change from Baseline in worst upper limb scores using the Ashworth Scale at Week 6 from Baseline. Upper limb includes finger, wrist, thumb, and elbow. Worst score was the highest value measured from the finger, wrist, thumb, or elbow at Baseline and Week 6 based on treated areas. The Ashworth Scale assesses the degree of muscle tone. It is a 5-point scale where 0 equals no increase in muscle tone and 4 equals very severe muscle rigidity. A low score indicates little or no stiffness. A high score indicates severe stiffness. A negative change from baseline score indicates improvement.|Baseline, Week 6|Intent to Treat||Number on a scale||Standard Deviation|Mean
702617|NCT00076687|Secondary|Change From Baseline in FEV1/FVC Ratio|Change from baseline in FEV1/FVC ratio. This ratio is calculated by dividing the FEV1 value by the FVC value. This represents that portion (or ratio) of FVC exhaled in one second.|Baseline, Week 6|Safety||Ratio||Standard Deviation|Mean
702618|NCT00076687|Primary|Change From Baseline in Forced Expiratory Volume (FEV1)|Change from baseline in observed FEV1 at one second. FEV1 is the maximum amount of air exhaled in one second. Patients perform three to eight exhalations into a spirometer with the highest value recorded at Baseline and Week 6.|Baseline, Week 6|Safety||Liters of air||Standard Deviation|Mean
702619|NCT00076687|Primary|Change From Baseline in Forced Vital Capacity (FVC)|Change from baseline in observed FVC. FVC is the maximum amount of air exhaled from the lungs after taking the deepest breath possible. Patients perform three to eight exhalations into a spirometer with the highest value recorded at Baseline and Week 6.|Baseline, Week 6|Safety||Liters of air||Standard Deviation|Mean
702620|NCT00076752|Secondary|Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)|The SLEDAI activity index test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Complete clinical response is defined as complete clinical response in the target organ and no clinical signs of active lupus as determined by a SLEDAI score of ≤3; partial response is at least 50% improvement in general disease activity as measured by SLEDAI. Remission is a SLEDAI score <3 and prednisone <10mg/day. 6+ indicates active disease requiring therapy. A score of 0 indicates a better outcome and a score greater then 6+ indicates a worse outcome.|Day -7, day 0, 1 month, 3 months, 6 months, 1 year, 18 months, 2 years and 3 years.|One participant was enrolled but the study was closed before the patient could be treated.||scores on a scale.||Standard Deviation|Mean
702621|NCT00076752|Secondary|Natural Killer Cells|The natural killer cells test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 87-505 uL.|Day 0, 1 month, 3 months, 6 months, 1 year and 2 years.|One participant was enrolled but the study was closed before the patient could be treated.||cells/mL^3||Standard Deviation|Mean
702622|NCT00076752|Secondary|Cluster of Differentiation 19 (CD19) + Cells|The CD19 + Cells test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 47-409 u/L.|Day 0, 1 month, 3 months, 6 months, 1 year and 2 years.|One participant was enrolled but the study was closed before the patient could be treated.||cells/mL^3||Standard Deviation|Mean
702623|NCT00076752|Secondary|Cluster of Differentiation 8 (CD8) + Cells|The CD8 + Cells test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 194-836 u/L.|Day 0, 1 month, 3 months, 6 months, 1 year and 2 years.|One participant was enrolled but the study was closed before the patient could be treated.||cells/mL^3||Standard Deviation|Mean
702624|NCT00076752|Secondary|Cluster of Differentiation 4 (CD4) + Cells|The CD4 + Cells test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 358-1259 uL.|Day 0, 1 month, 3 months, 6 months, 1 year and 2 years.|One participant was enrolled but the study was closed before the patient could be treated.||cells/mL^3||Standard Deviation|Mean
702625|NCT00076752|Secondary|Cluster of Differentiation 3 (CD3) + Cells|The CD3+Cells test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 650-2108 uL.|Day 0, 1 month, 3 months, 6 months, 1 year and 2 years.|One participant was enrolled but the study was closed before the patient could be treated.||cells/mL^3||Standard Deviation|Mean
702626|NCT00076752|Secondary|Platelet Count|The platelet count test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 162-380 K/uL.|Day -7, day 0, 1 3, and 6 months, 1 year, 18 months, 2 years and 3 years.|One participant was enrolled but the study was closed before the patient could be treated.||K/uL||Standard Deviation|Mean
702627|NCT00076752|Secondary|Absolute Lymphocyte Count|The absolute lymphocyte count test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 0.45-4.9 K/uL.|Day -7, day 0, 1 3, and 6 months, 1 year, 18 months, 2 years and 3 years.|One participant was enrolled but the study was closed before the patient could be treated.||K/uL||Standard Deviation|Mean
702628|NCT00076752|Secondary|Absolute Neutrophil Count|The absolute neutrophil count test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 1.29-7.5 K/uL.|Day -7, day 0, 1 3, and 6 months, 1 year, 18 months, 2 years and 3 years.|One participant was enrolled but the study was closed before the patient could be treated.||K/uL||Standard Deviation|Mean
702629|NCT00076752|Secondary|White Blood Cells|The white blood cell test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 3.4-9.6 K/uL.|Day -7, day 0, 1 3, and 6 months, 1 year, 18 months, 2 years and 3 years.|One participant was enrolled but the study was closed before the patient could be treated.||K/uL||Standard Deviation|Mean
702630|NCT00076752|Secondary|Anti-Smith-Ribonuclear Protein Antibody|Anti-Smith-Ribonuclear protein antibody is a well accepted biological clinical laboratory marker of systemic lupus.Range of normal values is 0-19 EU.|Day -7, day 0, 1 3, and 6 months, 1 year, 18 months and 2 years.|||EU||Standard Deviation|Mean
702631|NCT00076752|Secondary|Anti-Double Stranded Deoxyribonucleic Acid (DNA) Antibody|Anti-Double stranded deoxyribonucleic acid antibody is a well accepted biological clinical laboratory marker especially specific for systemic lupus. Range of normal values is 0-24 IU.|Day -7, day 0, 1 3, and 6 months, 1 year, 18 months, 2 years and 3 years.|One participant was enrolled but the study was closed before the patient could be treated.||IU||Standard Deviation|Mean
702632|NCT00076752|Secondary|Extractable Nuclear Antigen (ENA)|Extractable nuclear antigen is a well accepted biological clinical laboratory marker of systemic lupus. Range of normal values is 0-19.|Day -7, day 0, 1 3, and 6 months, 1 year, 18 months, 2 years and 3 years.|One participant was enrolled but the study was closed before the patient could be treated.||EU||Standard Deviation|Mean
702633|NCT00076752|Secondary|Anti-Nuclear Antibody|Anti-Nuclear antibody is a well accepted biological clinical laboratory marker of systemic lupus. Range of normal values is 0-0.9 EU.|Day -7, day 0, 1 3, and 6 months, 1 year, 18 months, 2 years and 3 years.|One participant was enrolled but the study was closed before the patient could be treated.||EU||Standard Deviation|Mean
702634|NCT00076752|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|18 months|||participants|||Number
702635|NCT00076752|Primary|Relapse-free Complete Clinical Response|Complete clinical response is defined as complete clinical response in the target organ and no clinical signs of active lupus as determined by a Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score of ≤3; prednisone ≤10mg/day at 6 months and ≤5mg/day at 12 months or later.|60 months|Ninth participant was taken off study before proceeding with transplant per principal investigator due to decision to put study on hold.||Months||Full Range|Median
702636|NCT00076804|Primary|Immunological Response: Median CD4 (IQR) Cell Count Increase From Baseline at 24 Months by Study Arm||24 months|||cells/uL||Inter-Quartile Range|Median
702637|NCT00076804|Primary|Immunological Response: Median CD4 (IQR) Cell Count Increase From Baseline at 12 Months by Study Arm||12 months|||cells/uL||Inter-Quartile Range|Median
702638|NCT00076804|Primary|Impact of DOT Compared to Self-administered Treatment as Measured by HIV Viral Load at 24 Months of Treatment|Proportion of Patients with HIV RNA Levels of <400 Copies/mL at 24 Months [Intention-to-treat (ITT)|24 months|||participants|||Number
702639|NCT00076804|Primary|Impact of DOT Compared to Self-administered Treatment as Measured by HIV Viral Load at 12 Months of Treatment|Proportion of Patients with HIV RNA Levels of <400 at 12 Months - Intention-to-treat|at 12 and 24 months of treatment|||participants|||Number
702640|NCT00076999|Primary|Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation|Intensity of adverse events were graded by the investigator based on the DAIDS standardized table (Division of AIDS, National Institute of Health). DAIDS Grade 3 (Severe) and Grade 4 (Life Threatening) were identified.|up to 288 weeks|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment.||participants|||Number
702641|NCT00076999|Primary|Number of Severe (DAIDS Grades 3 or 4) Adverse Events Related to Drug for Treated Patients by Age Group and Formulation|Intensity of adverse events were graded by the investigator based on the DAIDS standardized table (Division of AIDS, National Institute of Health). DAIDS Grade 3 (Severe) and Grade 4 (Life Threatening) were identified.|up to 288 weeks|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment.||participants|||Number
702642|NCT00076999|Secondary|Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 48||week 48|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment||participants|||Number
702643|NCT00076999|Secondary|Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 24||week 24|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment||participants|||Number
702644|NCT00076999|Secondary|Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 16||week 16|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment||participants|||Number
702645|NCT00076999|Secondary|Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 8||week 8|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment||participants|||Number
702646|NCT00076999|Secondary|Median Change From Baseline in CD4 Percent at Week 100 (Last Observation Carried Forward)|Percentage of lymphocytes that are CD4 cells|baseline, week 100|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment||percentage of cells||Inter-Quartile Range|Median
707356|NCT00122369|Primary|Pain Ratings at Specified Time Point During the Procedure|Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain|40 min|Patients remaining on procedure table||units on a scale||Inter-Quartile Range|Median
702648|NCT00076999|Secondary|Median Change From Baseline in CD4 Percent at Week 24 (Last Observation Carried Forward)|Percentage of lymphocytes that are CD4 cells|baseline, week 24|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment||percentage of cells||Inter-Quartile Range|Median
702649|NCT00076999|Secondary|Median Baseline CD4 Percent|Percentage of lymphocytes that are CD4 cells|baseline|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment||percentage of cells||Inter-Quartile Range|Median
702650|NCT00076999|Secondary|Median Change From Baseline in CD4+ Cell Count (Cells/mm3) at Week 100 (Last Observation Carried Forward)||baseline, week 100|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment||cells/mm3||Inter-Quartile Range|Median
702651|NCT00076999|Secondary|Median Change From Baseline in CD4+ Cell Count (Cells/mm3) at Week 48 (Last Observation Carried Forward)||baseline, week 48|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment||cells/mm3||Inter-Quartile Range|Median
702652|NCT00076999|Secondary|Median Change From Baseline in CD4+ Cell Count (Cells/mm3) at Week 24 (Last Observation Carried Forward)||baseline, week 24|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment||cells/mm3||Inter-Quartile Range|Median
702653|NCT00076999|Secondary|Baseline Median CD4+ Cell Count (Cells/mm3)||baseline|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment||cells/mm3||Inter-Quartile Range|Median
702654|NCT00076999|Secondary|Median Change From Baseline in Viral Load log10 Copies/mL at Week 100 (Last Observation Carried Forward)||baseline, week 100|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment||log10 copies/mL||Inter-Quartile Range|Median
702655|NCT00076999|Secondary|Median Change From Baseline in Viral Load log10 Copies/mL at Week 48 (Last Observation Carried Forward)||baseline, week 48|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment||log10 copies/mL||Inter-Quartile Range|Median
702656|NCT00076999|Secondary|Median Change From Baseline in Viral Load log10 Copies/mL at Week 24 (Last Observation Carried Forward)||baseline, week 24|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment||log10 copies/mL||Inter-Quartile Range|Median
702657|NCT00076999|Secondary|Baseline Median Viral Load log10 Copies/mL||baseline|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment||log10 copies/mL||Inter-Quartile Range|Median
702658|NCT00076999|Secondary|Number Patients With HIV RNA <50 Copies/mL at Week 100 (Non-completers Considered Failures)||baseline, week 100|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment||participants|||Number
702659|NCT00076999|Secondary|Number Patients With HIV RNA <50 Copies/mL at Week 48 (Non-completers Considered Failures)||baseline, week 48|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment||participants|||Number
702660|NCT00076999|Secondary|Number Patients With HIV RNA <50 Copies/mL at Week 24 (Non-completers Considered Failures)||baseline, week 24|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment||participants|||Number
702661|NCT00076999|Secondary|Number Patients With HIV RNA <400 Copies/mL at Week 100 (Non-completers Considered Failures)||baseline, week 100|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment||participants|||Number
702662|NCT00076999|Secondary|Number Patients With HIV RNA <400 Copies/mL at Week 48 (Non-completers Considered Failures)||baseline, week 48|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment||participants|||Number
702663|NCT00076999|Secondary|Number Patients With HIV RNA <400 Copies/mL at Week 24 (Non-completers Considered Failures)||baseline, week 24|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment||participants|||Number
702664|NCT00076999|Secondary|Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 100 (Non-completers Considered Failures)||baseline, week 100|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment||participants|||Number
702665|NCT00076999|Secondary|Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 48 (Non-completers Considered Failures)||baseline, week 48|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment||participants|||Number
702666|NCT00076999|Secondary|Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 24 (Non-completers Considered Failures)||baseline, week 24|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment||participants|||Number
702667|NCT00077207|Secondary|Response Rate Categorized as Complete Response, Partial Response, Stable Disease, or Progressive Disease|Response as complete response, partial response, stable disease, or progressive disease using three-dimensional imaging measurements (preferable) or two-dimensional imaging measurements, as well as the response in the context of multiple lesions or disseminated disease.|Up to 6 years||||||
702668|NCT00077207|Secondary|Event-free Survival (EFS)|Preliminary assessments of treatment efficacy will be based on response to induction therapy, 3-year event-free survival(EFS)|Up to 6 years||||||
702669|NCT00077207|Secondary|Progression-free Survival (PFS)|Preliminary assessments of treatment efficacy will be based on response to induction therapy, 3-year progression-free survival (PFS)|3 years||||||
702670|NCT00077207|Secondary|Grade 3 or 4 Thrombocytopenia and/or Neutropenia|Grade 3 or 4 thrombocytopenia and/or neutropenia that results in more than a 3 week delay in instituting the next cycle of chemotherapy despite protocol-directed reduction of up to 25% in Carboplatin and/or Temozolomide during the first 60 weeks of therapy|Up to 6 years||||||
702671|NCT00077207|Secondary|Occurrence of Toxic Death|Primary safety endpoints are (1) the occurrence of toxic death, which is death during treatment that is not primarily attributable to disease progression, and (2) the occurrence of grade 4 allergy to carboplatin.|Up to 6 years||||||
728439|NCT00380250|Secondary|Month 2 Bowel Straining Change From Baseline|0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|Change from baseline for month 2|ITT with LOCF||Scale score||Standard Deviation|Mean
702672|NCT00077207|Primary|Long Term Feasibility Success|"Success is defined as the completion of induction plus four cycles of maintenance within 60 weeks of enrollment without more than a 25% reduction in either carboplatin or temozolomide dosage.
If the participant completes all therapy within 60 weeks the patient is a long-term feasibility success. As such, a patient who experiences short term feasibility failure can be classified as a long-term feasibility success."|60 weeks|Fourteen (14) patients were considered not evaluable for long-term toxicity because: ineligible - 1 patient; progression during induction - 9 patients; progression during maintenance 2 patients; parent preference - 1 patient and infection resulting in termination of protocol therapy - 1 patient.||participants|||Number
702673|NCT00077207|Primary|Short Term Feasibility Success|"Success is defined as the completion of induction plus one cycle of maintenance within 24 weeks of enrollment without more than a 25% reduction in either carboplatin or temozolomide dosage.
Failure to complete the induction and one cycle of maintenance within 24 weeks counts as a short-term-feasibility failure."|24 weeks|Fourteen (14) patients were considered not evaluable for short-term toxicity because: ineligible - 1 patient; progression during induction - 9 patients; progression during maintenance 2 patients; parent preference - 1 patient and infection resulting in termination of protocol therapy - 1 patient.||participants|||Number
702674|NCT00077376|Secondary|Kaplan-Meier Estimate of Overall Survival at 3 Years for All Treated Patients|Survival estimate from the Kaplan-Meier curve of the proportion of patients alive at 3 years.|Assessed every 3 months for 2 years, then every 6 months for 3 years|All treated patients||Percentage of Participants||95% Confidence Interval|Number
702675|NCT00077376|Secondary|Kaplan-Meier Estimate of Overall Survival at 3 Years for HER2+ Patients|Survival estimate from the Kaplan-Meier curve of the proportion of patients alive at 3 years.|Assessed every 3 months for 2 years, then every 6 months for 3 years|HER2+ patients||Percentage of Participants||95% Confidence Interval|Number
702676|NCT00077376|Secondary|Time to Treatment Failure for All Treated Patients|Time from study entry to the date at which a patient was removed from treatment due to progression, toxicity, refusal or death. If a patient was considered to be a major treatment violation or was taken off study as a non-protocol failure, the patient would be censored on the date he/she was removed from treatment.|Assessed every cycle until treatment discontinuation|All treated patients||Months||95% Confidence Interval|Median
702677|NCT00077376|Secondary|Time to Treatment Failure for HER2+ Patients|Time from study entry to the date at which a patient was removed from treatment due to progression, toxicity, refusal or death. If a patient was considered to be a major treatment violation or was taken off study as a non-protocol failure, the patient would be censored on the date he/she was removed from treatment.|Assessed every cycle until treatment discontinuation|HER2+ patients||Months||95% Confidence Interval|Median
702678|NCT00077376|Secondary|Time to Disease Progression for All Treated Patients|This interval will be measured from the date of entry on the study to the appearance of new metastatic lesions or objective tumor progression based on RECIST. Patients progression-free at last follow-up were censored.|Assessed every 3 cycles during induction therapy and every 6 cycles during maintenance therapy until disease progression or up to 5 years|All treated patients||Months||95% Confidence Interval|Median
702679|NCT00077376|Secondary|Time to Disease Progression for HER2+ Patients|This interval will be measured from the date of entry on the study to the appearance of new metastatic lesions or objective tumor progression based on RECIST. Patients progression-free at last follow-up were censored.|Assessed every 3 cycles during induction therapy and every 6 cycles during maintenance therapy until disease progression or up to 5 years|HER2+ patients||Months||95% Confidence Interval|Median
702680|NCT00077376|Secondary|Objective Response for All Treated Patients (the Best Response a Patient Has Ever Experienced on Study)|"To assess objective response, it is necessary to estimate the overall tumor burden at baseline to which subsequent measurements will be compared. The same method of assessment and the same technique should be used to characterize each lesion at baseline and during follow-up.
The best overall response based on RECIST is the best response recorded from registration until disease progression/recurrence, taking as reference for progressive disease the smallest measurements recorded since registration. The best response was determined based on the tumor responses in target and nontarget lesions, with or without new lesions. To be assigned a status of complete or partial response, changes in tumor measurements must be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response are first met. To be assigned a status of stable disease, measurements must have met the stable disease criteria at least once after study entry at a minimum interval of 8 weeks."|Assessed every 3 cycles during induction therapy and every 6 cycles during maintenance therapy until disease progression or up to 5 years|All treated patients||Participants|||Number
702681|NCT00077376|Primary|Objective Response for HER2+ Patients (Best Objective Response a Patient Has Ever Experienced on Study)|"To assess objective response, it is necessary to estimate the overall tumor burden at baseline to which subsequent measurements will be compared. The same method of assessment and the same technique should be used to characterize each lesion at baseline and during follow-up.
The best overall response based on RECIST is the best response recorded from registration until disease progression/recurrence, taking as reference for progressive disease the smallest measurements recorded since registration. The best response was determined based on the tumor responses in target and nontarget lesions, with or without new lesions. To be assigned a status of complete or partial response, changes in tumor measurements must be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response are first met. To be assigned a status of stable disease, measurements must have met the stable disease criteria at least once after study entry at a minimum interval of 8 weeks."|Assessed every 3 cycles during induction therapy and every 6 cycles during maintenance therapy until disease progression or up to 5 years|HER2+ patients||Participants|||Number
702691|NCT00077623|Secondary|Change From Baseline in Systolic and Diastolic Blood Pressure at Weeks 36 and 52 in Peritoneal Dialysis Participants|Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was measured in sitting position before and after dialysis session in peritoneal dialysis participants.|From Baseline (Week -4 to Week -1) to Week 36 and Week 52|Safety population included all participants who received at least one dose of study medication. Maximum number of participants available at the time of assessment were analysed and reported.||mm HG||Standard Deviation|Mean
703676|NCT00095498|Secondary|Change From Baseline in Basophils at Month 12|Laboratory hematology basophils|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.||* 10^9/L||Standard Deviation|Mean
702682|NCT00077610|Secondary|Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs) and Death|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator’s judgment or requires intervention to prevent one or other of these outcomes. Overall deaths occurred in the study were reported.|Upto Week 53|The Safety Population was defined as all participants who received at least one dose of RO0503821 or Epoetin, and a safety follow-up, whether withdrawn prematurely or not. Participants available at particular time point were included in the analysis (n).||participants|||Number
702683|NCT00077610|Secondary|Mean Change in Pulse Rate (Sitting) From Baseline at Week 36 and Week 52|Change in pulse rate (beats per minute [bpm]) from baseline values includes only those participants with both a baseline value and a value for specified time period.|Baseline, Week 36 and Week 52|The Safety Population was defined as all participants who received at least one dose of RO0503821 or Epoetin, and a safety follow-up, whether withdrawn prematurely or not. Participants available at particular time point were included in the analysis (n).||beats per minute (bpm)||Standard Deviation|Mean
702684|NCT00077610|Secondary|Mean Change in Blood Pressure From Baseline at Week 36 and Week 52|Blood pressure was measured by manual assessment or automated reading throughout the entire study for every participant. Blood pressure was taken in the sitting position after at least 5 minutes rest. An appropriate -sized cuff was used and both systolic (SBP) and diastolic (DBP) blood pressures were recorded before dialysis (BD) and after dialysis (AD).|Baseline, Week 36 and Week 52|The Safety Population was defined as all participants who received at least one dose of RO0503821 or Epoetin, and a safety follow-up, whether withdrawn prematurely or not. Participants available at particular time point were included in the analysis (n).||millimeter of mercury (mmHg)||Standard Deviation|Mean
702685|NCT00077610|Secondary|Number of Participants With Marked Laboratory Abnormalities for Blood Chemistry and Electrolytes|Marked laboratory abnormalities were defined as those values that were outside the Roche marked abnormality reference range. These abnormality laboratory values were flagged as Low or High if they were below the lower limit or above the upper limit of Roche marked abnormality reference range, respectively. The marked abnormality reference range for aspartate aminotransferase (AST) was 0-80 (unit per litre [U/L]), alanine aminotransferase (ALT) 0-110 U/L, alkaline phosphatase (ALP) 0-220 U/L, albumin >=30.0 gram/litre (g/L), glucose in non-diabetics 2.80-11.10 (millimol/litre [mmol/L]); potassium 2.90-5.80 mmol/L, and phosphorus 0.75-1.60 mmol/L|Up to Week 53|The Safety Population was defined as all participants who received at least one dose of RO0503821 or Epoetin, and a safety follow-up, whether withdrawn prematurely or not. Participants available at particular time point were included in the analysis (n).||participants|||Number
702686|NCT00077610|Secondary|Number of Participants With Marked Laboratory Abnormalities in Platelet, White Blood Cell Counts (WBC) and Red Blood Cells (RBC)|Marked laboratory abnormalities were defined as those values that were outside the Roche marked abnormality reference range. These abnormality laboratory values were flagged as Low or High if they were below the lower limit or above the upper limit of Roche marked abnormality reference range, respectively. The marked abnormality reference range for Platelet was 100-550x10^9/Litre [L], for WBC was 3.0-18.0.0x10^9/L, and for RBC was 3.80-6.10x10^12/L.|Up to Week 53|The Safety Population was defined as all participants who received at least one dose of RO0503821 or Epoetin, and a safety follow-up, whether withdrawn prematurely or not. Participants available at particular time point were included in the analysis (n).||participants|||Number
702687|NCT00077610|Secondary|The Incidence of Red Blood Cell (RBC) Transfusions During the Titration and Evaluation Periods|The number of participants who received RBC transfusions during the titration and evaluation periods were reported .|Week 1 to Week 36|The Safety Population was defined as all participants who received at least one dose of RO0503821 or Epoetin, and a safety follow-up, whether withdrawn prematurely or not.||participants|||Number
702688|NCT00077610|Secondary|Number of Participants Maintaining Average Hemoglobin Concentration During Evaluation Period Within +/- 1 Gram Per Deciliter (g/dl) of Average Baseline Hemoglobin Concentration.|The mean Hb of all values recorded during the evaluation period were calculated, and were subtracted from the mean baseline Hb for each participant. The number of participants maintaining their average Hb within +/- 1 g/dL of their average baseline hemoglobin concentration is given.|Baseline, Week 29 to Week 36|The intent-to-treat (ITT) population was defined as all randomized participants. At the end of Week 36, data allowing the evaluation of the therapeutic response was available for 196/221, 188/220, and 205/225 participants in RO0503821 (1x/2 Weeks), RO0503821 (1x/4 Weeks), and Epoetin (1 -3x/Weeks), respectively.||participants|||Number
702689|NCT00077610|Primary|Mean Change in Hemoglobin (Hb) Concentration From Baseline to Evaluation Period|A time adjusted mean change in Hb concentration was calculated using an Area Under the Curve (AUC) approach, for both periods separately. Change in Hb concentration between the Baseline and evaluation periods was calculated by subtracting the calculated average baseline Hb from the average evaluation period Hb. At the end of the Week 36, data allowing the evaluation of the therapeutic response was available for 188 out of 221 eligible participants in RO0503821 (1x/2 Weeks) arm; 172 out of 220 eligible participants in RO0503821 (1x/4 Weeks); and 180 out of 225 participants in Epoetin (1-3x/Weeks) arm.|Baseline, Week 29 to Week 36|The Per Protocol population included all randomized participants except those not meeting inclusion criterion related to Hb parameters and <5 recorded Hb values during the evaluation period with missing administrations of the study drug/ reference drug. Please refer to the outcome measure description section for more details.||gram per deciliter (g/dL)||Standard Deviation|Mean
702690|NCT00077623|Secondary|Change From Baseline in Pulse Rate - Peritoneal Dialysis Participants|Pulse rate in BpM was measured at each study visit, i.e., once a week during the dose titration and evaluation periods, once every two weeks during the long-term safety observation period and at the final visit. It was measured before blood sampling and RO0503821/epoetin administration and before the dialysis session in peritoneal dialysis participants.|From Baseline (Week -4 to Week -1) to Week 36 and Week 52|Safety population included all participants who received at least one dose of study drug. Maximum number of participants available at the time of assessment was denoted as ‘n’.||BpM||Standard Deviation|Mean
702692|NCT00077623|Secondary|Change From Baseline in Pulse Rate at Weeks 36 and 52 in Hemodialysis Participants|Pulse rate in beats per minute (BpM) was measured at each study visit, i.e., once a week during the dose titration and evaluation periods, once every two weeks during the long-term safety observation period and at the final visit. It was measured before blood sampling and RO0503821/epoetin administration and before the dialysis session in haemodialysis participants.|From Baseline (Week -4 to Week -1) to Week 36 and Week 52|Safety population included all participants who received at least one dose of study drug. Maximum number of participants available at the time of assessment was denoted as ‘n’.||BpM||Standard Deviation|Mean
702693|NCT00077623|Secondary|Change From Baseline in Systolic and Diastolic Blood Pressure - at Weeks 36 and 52 in Hemodialysis Participants|Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was measured in sitting position before and after dialysis session in haemodialysis participants.|From Baseline (Week -4 to Week -1) to Week 36 and Week 52|Safety population included all participants who received at least one dose of study drug. Maximum number of participants available at the time of assessment was denoted as ‘n’.||mmHG||Standard Deviation|Mean
702694|NCT00077623|Secondary|Number of Participants With Marked Laboratory Abnormalities|A marked abnormality range was defined as above and/or below a value which was considered to be potentially clinically relevant. Marked laboratory abnormalities were analyzed according to the Roche specified limits for the reference range of the following laboratory parameters: White blood cells (WBC) (3.0– 18.0 10^9/L), platelets (100 – 550 10^9/L), alanine aminotransferase (ALAT) (0 – 110 units per liter [U/L]), alkaline phosphatase (ALP [0 – 220 U/L]), aspartate aminotransferase (ASAT) (0 – 80 U/L), albumin >= 30 g/L, phosphate (0.75 - 1.60 millimoles per liter [mmol/L]), potassium (2.9 – 5.8 mmol/L), glucose (2.80 – 11.10 mmol/L).|Up to week 52|Safety population included all participants who received at least one dose of study drug. Maximum number of participants available at the time of assessment were denoted as ‘n'.||participants|||Number
702695|NCT00077623|Secondary|Number of Participants With Any Adverse Events, Any Serious Adverse Events, and Deaths|An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Up to week 52|Safety population included all participants who received at least one dose of study drug.||participants|||Number
702696|NCT00077623|Secondary|Number of Participants With Red Blood Cell Transfusions|The number of participants who received RBC transfusions were reported.|Up to Week 36|Safety population included all participants who received at least one dose of study drug.||participants|||Number
702697|NCT00077623|Secondary|Number of Participants Maintaining Average Hb Concentration During the Evaluation Period Within +-1 g/dL of Their Average Baseline Hb Concentration|All mean Hb values recorded during the evaluation period were calculated and subtracted from the mean baseline Hb value for each participant. The number of participants maintaining their average Hb within +/- 1 g/dL of their average baseline hemoglobin concentration is given. The evaluation period is defined as Week 29 to Week 36.|Evaluation period (Week 29 to Week 36)|The Intent-to-Treat (ITT) population included all randomized participants.||participants|||Number
702698|NCT00077623|Primary|Mean Change in Hemoglobin Concentration From Baseline to Evaluation Periods|A time adjusted mean change in hemoglobin (Hb) concentration was calculated using an area under the curve (AUC) approach, for both periods separately. Change in Hb concentration between the baseline and evaluation periods was calculated by subtracting the calculated average baseline Hb value from the average evaluation period Hb value. All blood samples for Hb measurements were taken prior to study drug administration. Analysis used last observation carried forward (LOCF) for missing Hb values to correct for the impact of early dropouts. The baseline period is defined as Week -4 to Week -1. The evaluation period is defined as Week 29 to Week 36.|Baseline (Week -4 to Week -1) and Evaluation period (Week 29 to Week 36)|The Per Protocol population included all randomized participants except those not meeting inclusion criterion related to stable baseline Hb values, inadequate iron status, hemoglobinopathies/hemolysis, RBC transfusion/blood loss, with <5 recorded Hb values during the evaluation period, with missing administrations of the study drug/ reference drug||g/dL||Standard Deviation|Mean
702699|NCT00077636|Secondary|Number of Participants With Highest Triglyceride Level|Participants with triglyceride level above normal (i.e. < 200 mg/dL) were analysed.|Up to Week 40 and Week 48|The safety population includes all randomized patients who received at least one dose of either study drug and had at least one post baseline safety assessment.||participants|||Number
702700|NCT00077636|Secondary|Participants With Marked Abnormal Vital Signs|Participants with changes in Systolic and diastolic blood pressure, heart rate were analysed abnormal vital signs.|Up to Week 40 and Week 48|Safety population: The safety population includes all randomized patients who received at least one dose of either study drug and had at least one post baseline safety assessment.||participants|||Number
702701|NCT00077636|Secondary|Percentage of Participants With Marked Laboratory Abnormalities|Participants with changes in Hematocrit: Fraction 0.36 – 0.60 g/dL, Hemoglobin: 11.0 –20.0 g/dL, WBC 3.0 – 18.0 g/dL, Platelets 100 – 700 g/dL, Basophils 0.00 – 0.30 g/dL, Lymphocytes 1.00 – 6.30 g/dL, Monocytes 0.08 – 2.00 g/dL, Neutrophils 1.50 or more g/dL, Eosinophils 0.00 – 1.50 g/dL , PTT 0 – 50 seconds, Alkaline Phosphatase 0 – 190 and ASAT 0 – 50 U/L, ALAT 0 – 60 U/L, Gamma – GT 0 – 120 U/L, Total Protein 55 – 87 g/L ;Albumin 27.0 or more g/L, Total Bilirubin 0 – 34.2 μmol/L, BUN 0 – 14.3 mmol/L, Creatinine 0 – 154 μmol/L, Free T3, T4 5 – 40 pmol/L, TSH 0.0 – 10.0 mU/L, Cholesterol 0.0 – 8.3 mmol/L; Triglycerides 0.00 – 2.83 mmol/L, Chloride 95 – 115 mmol/L; Potassium 3.0 – 6.0 mmol/L; Sodium 130 – 150 mmol/L, miscellaneous: Calcium 2.00 – 2.90 mmol/L; Phosphate 0.75 – 1.60 mmol/L; Blood Glucose (Random) 2.80 – 11.10 mmol/L, Uric Acid 0 – 600 μmol/L, Proteinuria, Glycosuria, Hematuria (Qualitative 0 to 4+) 0 – 1 were analysed for the laboratory abnormality.|Up to Week 40 and Week 48|Safety population: The safety population includes all randomized patients who received at least one dose of either study drug and had at least one post baseline safety assessment.||Percentage of participants|||Number
702834|NCT00088530|Secondary|Progression-Free Survival (PFS)|The time between the date of randomization and the date of the initial documentation of progressive/relapsed disease or death due to any cause.|18 months after 6 cycles of treatment; approximately 24 months|Intent-to-treat patients||months||95% Confidence Interval|Median
702702|NCT00077636|Secondary|Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An adverse event was defined as any untoward medical occurrence that occurred during he course of the trial after study treatment had started. An adverse event was therefore any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.|Up to Week 40 and Week 48|Safety population: The safety population includes all randomized patients who received at least one dose of either study drug and had at least one post baseline safety assessment.||Percentage of participants|||Number
702703|NCT00077636|Secondary|Percentage of Participants Virological Response 12 Weeks Post-Treatment|Virological response 12 weeks post-treatment was defined as the percentage of participants with undetectable HCV RNA 12 weeks after the completion of the study treatment . The negative assessment was required to be the last one collected in the week 28 time window for the 16- week treatment group or in the week 36 time window for the 24-week treatment group.|Week 28 (for 16-week treatment group); Week 36 (for 24-week treatment group)|Standard population: The standard population included all randomized participants who received at least one dose of study medication and who did not have any of the major protocol violations or deviations.||Percentage of participants|||Number
702704|NCT00077636|Secondary|Percentage of Participants With Virological Response at The End of Study Treatment|Virological response was defined as the percentage of participants with undetectable HCV RNA at the completion of the study treatment. The negative assessment was required to be the last one collected in the Week 16 time window for the 16-week treatment group or in the Week 24 time window for the 24-week treatment group.|Week 16 (for 16-week treatment group); Week 24 (for 24-week treatment group)|Standard population: The standard population included all randomized participants who received at least one dose of study medication and who did not have any of the major protocol violations or deviations.||Percentage of participants|||Number
702705|NCT00077636|Primary|Percentage of Participants With Sustained Virological Response (SVR)|SVR was defined as the percentage of participants with undetectable HCV RNA at 24 weeks after the completion of the study treatment. The negative assessment was required to be the last one collected at or after week 36 (ie, on or after study Day 253) for the 16-week treatment group or at or after week 44 (ie, on or after study Day 309) for the 24-week treatment group.|Week 40 (for 16-week treatment group); Week 48 (for 24-week treatment group)|Standard population: The standard population includes all randomized participants who received at least one dose of study medication and who did not have any of the major protocol violations or deviations.||percentage of participants|||Number
702706|NCT00077649|Primary|Percentage of Participants With Predicted Sustained Virological Response|The predicted sustained virological response (SVR) for each treatment group, is determined using a model based on the log10-transformed HCV viral load in copies/mL at Week 4 and the virological response status at Week 12. Each participant was classified as a predicted SVR if p was ≥ 0.5 or as a non-SVR if p was <0.5. The percentage was calculated from the number of participant (N) analyzed under “Distribution of the predicted probability of an SVR.”|Week 4 and 12|The ITT population consisted of all participants who were randomized and received at least one dose of either of the study medication.||percentage of participants|||Number
702707|NCT00077649|Primary|Percentage of Participants With Virological Response Over Time to Week 24|Virological response over time to Week 24 is defined as the percentage of participants with undetectable HCV RNA as measured by the Roche Amplicor HCV Test, V. 2.0 (detection limit = 50 IU/mL) at 72 hours and at weeks 1, 2, 12, and 24.|72 hours post-dose, Weeks 1, 2, 4, 12, and 24|The ITT population consisted of all participants who were randomized and received at least one dose of either of the study medication.||percentage of participants||95% Confidence Interval|Number
702708|NCT00077649|Secondary|Total BDI-II (Beck Depression Inventory) Scores|The BDI-II is a self-reported assessment of 21 items which included sadness, pessimism, past failure, loss of pleasure, guilty feelings, punishment feelings, self-dislike, self-criticalness, suicidal thoughts or wishes, crying, agitation, loss of interest, indecisiveness, worthlessness, loss of energy, changes in sleeping pattern, irritability, changes in appetite, concentration difficulty, tiredness or fatigue, loss of interest in sex that are summarized by treatment group. All except two items had four statements that were scored on a scale ranging from 0 to 3. The maximum total score was 63. The scores for each item were summed to obtain the total for that assessment. The participants neurological status could then be categorized as follows: minimal depression: 0 to 13; mild depression: 14 to 19; moderate depression: 20 to 28; and severe depression: 29 to 63. The BDI-II questionnaire was self-administered by the patient at each visit.|From Baseline (Day 1) to Week 72|The safety population consisted of all participants who received at least one dose of either of the study drug and have at least one post-baseline safety assessment. Participants available at particular time point for assessment were included in the analysis.||Units on a scale||Standard Deviation|Mean
702709|NCT00077649|Secondary|Percentage of Participants With Abnormal Vital Signs|Vital signs (Systolic blood pressure, Diastolic blood pressure, Pulse rate) were considered to be abnormal and of potential clinical relevance if the values measured for these parameters represented a change from baseline of greater than 20% in the direction of worsening. High diastolic blood pressure is defined as >110 mmhg and >20% increase from baseline. High systolic blood pressure is defined as >180 mmhg and >20% increase from baseline. Low systolic blood pressure is defined as <85 mmhg and >20% decrease from baseline. High heart rate is defined as >120 beats/minute and >20% increase from baseline. Low heart rate is defined as < 50 beats/minute and >20% decrease from baseline.|Up to Week 72|The safety population consisted of all participants who received at least one dose of either of the study drug and have at least one post-baseline safety assessment. Participants available at particular time point for assessment were included in the analysis.||percentage of participants|||Number
702718|NCT00077766|Secondary|Mean Change in Pulse Rate (Sitting) From Baseline at Week 36 and Week 52|Change in pulse rate (beats per minute [bpm]) from baseline values includes only those participants with both a baseline (BL) value and a value for specified time period.|Baseline, Week 36, and Week 52|The safety population was defined as all participants who received at least one dose of RO0503821 or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not. Data from participants available at protocol specified assessment time point were included in the analysis (n).||beats per minute||Standard Deviation|Mean
702882|NCT00089141|Primary|Cure of Chronic GVHD Without Resorting to Secondary Systemic Therapy|Withdrawal of all systemic immunosuppressive treatment after resolution of chronic GVHD, before death or onset of recurrent malignancy|2 years|||participants|||Number
702710|NCT00077649|Secondary|Percentage of Participants With Marked Laboratory Abnormalities|Marked laboratory abnormalities are the values outside the roche defined reference range.It is hemoglobin 11.0 – 20.0 (g/dL),platelets 100 – 700 (10^9/L), lymphocyte 1.00 – 6.30 (10^9/L),neutrophils 1.50 or more (10^9/L), white blood cells(WBC) 3.0 – 18.0 (10^9/L),serum glutamic-pyruvic transaminase (SGPT) 0 – 60 (U/L), serum glutamic oxaloacetic transaminase (SGOT) 0 – 50 (U/L), alkaline phosphatase 0 – 190 (U/L),albumin was 27.0 or more (g/L),gamma glutamyl transferases (GGT) 0 – 120 (U/L),Total protein 55 – 87 (g/L),total bilirubin 0 – 34.2 (μmol/L),BUN 0 – 14.3 (mmol/L),creatinine 0 – 154 (μmol/L),chloride 95 – 115 (mmol/L),potassium 3.0 – 6.0 (mmol/L), sodium 130 – 150 (mmol/L),thyroid stimulating hormone (TSH) 0.0 – 10.0 (mU/L),triglycerides 0.00 – 2.83 (mmol/L), calcium 2.00 – 2.90 (mmol/L),phosphate 0.75 – 1.60 (mmol/L),Blood Glucose 2.80 – 11.10 (mmol/L),Uric Acid 0 – 600 (μmol/L),proteinuria 0 – 1 (0 to 4+), glycosuria 0 – 1 (0 to 4+), hematuria 0 – 1 (0 to 4+).|Up to Week 60|The safety population consisted of all participants who received at least one dose of either of the study drug and have at least one post-baseline safety assessment. Participants available at particular time point for assessment where included in the analysis.||percentage of participants|||Number
702711|NCT00077649|Secondary|Percentage of Participants With Adverse Events and Serious Adverse Events|An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. A serious adverse event is any adverse event (SAE) that can result in death or is Life-threatening or required in-patient hospitalization or prolongation of existing hospitalization or results in persistent or significant disability/incapacity; or is a congenital anomaly/birth defect; or is medically significant or requires intervention to prevent one or other of the outcomes listed above.|Up to Week 72|The safety population consisted of all participants who received at least one dose of either of the study drug and have at least one post-baseline safety assessment. Participants available at particular time point for assessment were included in the analysis.||percentage of participants|||Number
702712|NCT00077649|Secondary|Percentage of Participants With Virological Response At 12 Weeks After The End of The Treatment Period|Virological response at 12 weeks after the end of the treatment period is defined as the percentage of participants with undetectable HCV RNA as measured by the Roche Amplicor HCV Test, v 2.0 (detection limit = 50 IU/mL) at 12 weeks after completion of the treatment period.|Week 60|The ITT population consisted of all participants who were randomized and received at least one dose of either of the study medication.||percentage of participants||95% Confidence Interval|Number
702713|NCT00077649|Secondary|Percentage of Participants With Virological Response at the End of the Treatment Period|Virological response at the end of the treatment period is defined as the percentage of participants with undetectable HCV RNA as measured by the Roche Amplicor HCV Test, v 2.0 (detection limit = 50 IU/mL) at the completion of the treatment period.|Week 48|The ITT population consisted of all participants who were randomized and received at least one dose of either of the study medication.||percentage of participants||95% Confidence Interval|Number
702714|NCT00077649|Secondary|Percentage of Participants With Sustained Virological Response|SVR is defined as the percentage of participants with undetectable HCV RNA as measured by the Roche Amplicor HCV Test, v 2.0 (detection limit = 50 IU/ml) at the end of the 24-week untreated follow-up period.|Week 72|The ITT population consisted of all participants who were randomized and received at least one dose of either of the study medication.||percentage of participants||95% Confidence Interval|Number
702715|NCT00077649|Primary|HCV RNA Profile During The First 24 Weeks|Viral loads (quantitative HCV RNA) collected during the initial 24 weeks were first logarithmically (based 10) transformed. Results falling below the assay sensitivity level were set to the assay sensitivity level before the analyses. Thus, a qualitative HCV RNA negative result was set to 50 IU/mL (or 100 copies/mL). A qualitative HCV RNA positive result along with an unquantifiable HCV RNA result from the quantitative assay corresponded to a numeric HCV RNA result of 600 IU/mL (or 1000 copies/mL).|Baseline (Day 1), At 72 hour (h), Week (W)-1, 2, 4, 12, 24|The ITT population consisted of all participants who were randomized and received at least one dose of either of the study medication.||log 10 copies/mL||Standard Deviation|Mean
702716|NCT00077675|Primary|Clinical Response Which is Measured at Test of Cure (TOC) in the Clinically Evaluable (CE) Population|"Cure: Resolution of clinically significant signs, symptoms associated with the skin infection present at study admission or improvement to the extent that the infectious process had been controlled and no further therapy with study medication was necessary.
Failure: Inadequate response to study therapy or the need for significant surgical management (e.g. more than just routine debridement) of the infection site following antibiotic therapy and prior to Test-of-Cure (TOC) visit
Indeterminate: Inability to determine outcome."|7 to 14 days following completion of antibiotic treatment|"The CE population was a subset of the All Treated Population and was composed of patients who met the inclusion/exclusion criteria or were granted permission to enroll and had a clinical response of cure or failure. The All Treated Population patients received at least one treatment. The Primary Efficacy Analysis was of the CE population."||participants|||Number
702717|NCT00077766|Secondary|Number of Participants With Any Adverse Events, Any Serious Adverse Event, and Deaths|An Adverse Event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator’s judgment or requires intervention to prevent one or other of these outcomes. Overall deaths occurred in the study were reported.|Up to Week 52|The safety population was defined as all participants who received at least one dose of RO0503821 or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not.||Participants|||Number
703180|NCT00090610|Secondary|Recurrence-Free Survival|Recurrence-free survival is based on measurable disease using Kaplan-Meier estimates for the intent to treat (ITT) Population who achieved a complete response.|Every 6 months starting at 12 months, to 24 months|Subjects who had a complete response.||months||95% Confidence Interval|Median
702719|NCT00077766|Secondary|Mean Change in Blood Pressure From Baseline at Week 36 and Week 52|Blood pressure Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) was measured by manual assessment or automated reading throughout the study for every participant. Blood pressure was taken in the sitting position after at least 5 minutes rest. An appropriate -sized cuff was used and both systolic and diastolic blood pressures were recorded before dialysis (BD) and after dialysis (AD).|Baseline, Week 36, and Week 52|The safety population was defined as all participants who received at least one dose of RO0503821 or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not. Data from participants available at protocol specified assessment time point were included in the analysis (n).||millimeters of mercury (mm Hg)||Standard Deviation|Mean
702720|NCT00077766|Secondary|Number of Participants With Marked Laboratory Abnormalities|A marked abnormality range was defined as above and/or below a value which was considered to be potentially clinically relevant. Marked laboratory abnormalities were analyzed according to the Roche specified limits for the reference range of the following laboratory parameters: White blood cells (WBC) (3.0– 18.0 10^9/liter [L]), platelets (100 – 550 10^9/L), (alanine aminotransferase [(ALAT)] (0 – 110 units per liter [U/L]), alkaline phosphatase (ALP) (0 – 220 U/L), aspartate aminotransferase (ASAT) (0 – 80 U/L), albumin >= 30 g/L, phosphate (0.75 - 1.60 millimole per liter [mmol/L]), potassium (2.9 – 5.8 mmol/L), glucose (2.80 – 11.10 mmol/L).|Up to Week 52|The safety population was defined as all participants who received at least one dose of RO0503821 or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not. Data from participants available at protocol specified assessment time points were included in the analysis (n).||Participants|||Number
702721|NCT00077766|Secondary|Number of Participants With Red Blood Cell Transfusions During the Dose Titration and Evaluation Periods|A combined data of the number of participants who received Red Blood Cell (RBC) transfusions during the titration and evaluation periods is reported. A period of 28 weeks after the first dose of the study drug was used for dose titration and stabilization of Hb concentration. The dose titration period was followed by an 8-week evaluation period (weeks 29 to 36).|Week 1 to Week 36|The safety population was defined as all participants who received at least one dose of RO0503821 or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not.||Participants|||Number
702722|NCT00077766|Secondary|Number of Participants Maintaining Average Hemoglobin Concentration During the Evaluation Period Within +-1 g/dL of Their Average Baseline Hemoglobin Concentration|The average Hb of all values recorded during the evaluation period was calculated, and this average was subtracted from the average baseline Hb values for each participant. The number of participants maintaining their average Hb within +/- 1 g/dL of their average baseline Hb concentration is displayed. The evaluation period was defined as Week 29 to Week 36.|Baseline (Week -4 to Week -1) and Evaluation Period (Week 29 to Week 36)|The Intent-to-Treat (ITT) population was defined as all randomized participants. Participants with available data at the time of evaluation were analyzed.||Participants|||Number
702723|NCT00077766|Primary|Mean Change in Hemoglobin Concentration (g/dL) From Baseline to Evaluation Period|A time adjusted mean change in hemoglobin (Hb) concentration was calculated using an area under the curve approach, for both periods separately. Change in Hb concentration between the baseline (Week -4 to Week -1) and evaluation periods was calculated by subtracting the calculated average baseline Hb value from the average evaluation period Hb value. All blood samples for Hb measurements were taken prior to study drug administration. The analysis used the last observation carried forward (LOCF) for missing Hb values for correction of the impact of early drop outs. The baseline period was defined as Week -4 to Week -1. The evaluation period was defined as Week 29 to Week 36.|Baseline (Week -4 to Week -1) and Evaluation Period (Week 29 to Week 36)|The per protocol population was all randomized and treated participants, except those who had not met criteria for stable baseline Hb,and adequate iron levels or had hemoglobinopathies/hemolysis, RBC transfusion/blood loss, <5 recorded Hb values during evaluation or missed administrations of trial drugs in week 26 to 35.||gram per deciliter (g/dL)||Standard Deviation|Mean
702724|NCT00077857|Secondary|Number of Participants With Adverse Events and Serious Adverse Events|"An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events.
A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is Life-Threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
Additional information about Adverse Events can be found in the Adverse Event Section."|First study drug intake until last study drug intake plus 28 days|Safety Population included all randomized participants who received study drug. Note: 14 patients randomized to 1250 mg/m^2 actual received an initial dose that ranged from 480 to 984 mg/m^2 so are included in the 825 mg/m^2 arm for safety.||Participants|||Number
702725|NCT00077857|Secondary|Overall Survival|Overall Survival was measured as the time from the date of randomization to the date of death.|Throughout the study. Median observation time was approximately 16 months.|Intent to treat population included all randomized participants.||Months||95% Confidence Interval|Median
702726|NCT00077857|Secondary|Time to Treatment Failure|"The time to treatment failure was the time from the date of randomization to the first occurrence of any of the following events:
adverse events
insufficient therapeutic response (disease progression)
death
failure to return
refusing treatment/being unwilling to cooperate
withdrawing consent."|Until premature withdrawal or end of primary study treatment (up to 16 cycles).|Safety Population included all randomized participants who received study drug. Note: 14 patients randomized to 1250 mg/m^2 actual received an initial dose that ranged from 480 to 984 mg/m^2 so are included in the 825 mg/m^2 arm for safety.||Months||95% Confidence Interval|Median
702727|NCT00077857|Secondary|Duration of Overall Response|Duration of overall response was measured from the time that measurement criteria were first met for Complete Response or Partial Response until the first date that progressive disease or death was documented.|Until PD or death. Median duration of response was approximately 7 months.|Intent to treat population included all randomized participants.||Months||95% Confidence Interval|Median
702883|NCT00089297|Secondary|Overall Survival|Overall survival is defined as the time from registration to death of any causes.|Weekly during treatment, and then every every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry|Only eligible patients are included in the analysis.||Months||95% Confidence Interval|Median
702728|NCT00077857|Secondary|Time to Overall Response|For patients with Best Overall Response being Complete Response (CR) or Partial Response (PR), time to response was measured as the time from randomization to the first time when the measurement criteria for CR or PR were met. The percentage of participants with overall response within the given time ranges in each of the categories: Weeks 1-6, 7-12, 13-18, 19-24, 25-30, 31-36, and 43-48 are reported.|Until PD or end of primary study treatment (up to 16 cycles) plus 28 days.|Intent to treat population included all randomized participants.||Percentage of participants|||Number
702729|NCT00077857|Secondary|Percentage of Participants With Best Overall Response Being Complete Response (CR) or Partial Response (PR)|According to Response Evaluation Criteria in Solid Tumors (RECIST) criteria: CR is defined as the disappearance of all target lesions and PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the nadir sum LD.|Until Progressive Disease (PD) or end of primary study treatment (up to 16 cycles) plus 28 days.|Intent to treat population included all randomized participants.||Percentage of participants||95% Confidence Interval|Number
702730|NCT00077857|Primary|Time to Progression of Disease or Death|Progression Free Survival was defined as the time from the date of randomization to the day of documented disease progression or death due to any cause.|Event driven (after 350 events). Median observation time was approximately 16 months.|Per protocol population included all participants who received at least one dose of study and who did not have any major protocol deviations.||Months||95% Confidence Interval|Median
702731|NCT00077922|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|54 months|||Participants|||Number
702732|NCT00077922|Primary|Response Rate|Response is measured by the 1996 National Cancer Institute (NCI) Working Group Criteria (NCIWG). Complete response is defined as no hepatomegaly, splenomegaly, or lymphadenopathy by physical examination and appropriate radiographic techniques. Lymph nodes must resolve to <1.0cm of 1-1.5cm at baseline, or <1.5cm if >1.5cm at baseline. Partial response is >=50% decrease in peripheral blood lymphocytes count from the pretreatment baseline value. Progressive disease is >=50% increase in the sum of the products of the greatest perpendicular dimensions of a t least 2 lymph nodes on two consecutive examinations 2 weeks apart (at least 1 node must be >=2cm) or appearance of new palpable lymph nodes. Stable disease is characterized by not meeting the above criteria. For additional details about the NCIWG, see the protocol link module.|Patients were followed for at least 30 days after last treatment. Because the study allows 6 treatment cycles, this can be up to 7 months.|||Participants|||Number
702733|NCT00077974|Secondary|Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite|Dose corrected plasma trough (predose) (Cmin) concentrations of sunitinib plus its metabolite (SU012662). Dose—corrected trough concentrations were set to missing for trough samples collected outside acceptable times from dose administration, samples not collected within scheduled day range, samples with missing collection or administration dates or times, samples collected with dose interruption, and samples collected with inconsistent dose level within 10 days of last dose date.|Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater|Pharmacokinetic analysis population||nanograms per milliliter||Standard Deviation|Mean
702734|NCT00077974|Secondary|Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite|Dose corrected plasma trough (predose) (Cmin) concentrations of sunitinib metabolite (SU012662). Dose—corrected trough concentrations were set to missing for trough samples collected outside acceptable times from dose administration, samples not collected within scheduled day range, samples with missing collection or administration dates or times, samples collected with dose interruption, and samples collected with inconsistent dose level within 10 days of last dose date.|Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater|Pharmacokinetic analysis population||nanograms per milliliter||Standard Deviation|Mean
702735|NCT00077974|Secondary|Dose Corrected Plasma Trough Concentrations of Sunitinib|Dose corrected plasma trough (predose) (Cmin) concentrations of sunitinib. Dose—corrected trough concentrations were set to missing for trough samples collected outside acceptable times from dose administration, samples not collected within scheduled day range, samples with missing collection or administration dates or times, samples collected with dose interruption, and samples collected with inconsistent dose level within 10 days of last dose date.|Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater|Pharmacokinetic analysis population||nanograms per milliliter||Standard Deviation|Mean
702736|NCT00077974|Secondary|Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite|Observed plasma trough (predose) concentrations of sunitinib plus its metabolite (SU012662)|Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater|Pharmacokinetic analysis population||nanograms per milliliter||Standard Deviation|Mean
702737|NCT00077974|Secondary|Observed Plasma Trough Concentrations of Sunitinib Metabolite|Observed plasma trough (predose) (Cmin) concentrations of sunitinib metabolite (SU012662)|Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater|Pharmacokinetic analysis population||nanograms per milliliter||Standard Deviation|Mean
702738|NCT00077974|Secondary|Observed Plasma Trough Concentrations of Sunitinib|Observed plasma trough (predose) (Cmin) concentrations of sunitinib|Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater|Pharmacokinetic analysis population||nanograms per milliliter||Standard Deviation|Mean
702739|NCT00077974|Secondary|Percent Chance of Patient Survival|Probability of survival 1 year and 2 years after the first dose of study treatment|From start of study treatment until death|ITT||percent chance of survival|||Number
702740|NCT00077974|Secondary|Progression-free Survival (PFS)|Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was “Death”).|From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter or death|ITT||weeks||95% Confidence Interval|Median
702741|NCT00077974|Secondary|Overall Survival (OS)|Time in weeks from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the subject current status was death).|From start of study treatment until death|ITT||weeks||95% Confidence Interval|Median
702742|NCT00077974|Secondary|Duration of Response (DR)|"Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7.
DR was calculated for the subgroup of patients with a confirmed objective tumor response."|Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter or death due to cancer|ITT subgroup of patients with a confirmed objective tumor response||weeks||95% Confidence Interval|Median
702743|NCT00077974|Secondary|Time to Tumor Progression (TTP)|Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever comes first. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]).|From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter|ITT||weeks||95% Confidence Interval|Median
702744|NCT00077974|Primary|Number of Subjects With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors(RECIST)|Overall confirmed objective response = confirmed Complete Response (CR) or confirmed Partial Response (PR) according to RECIST. CR defined as disappearance of all target lesions. PR defined as >= 30 percent decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter|The intent-to-treat (ITT) population included all subjects who enrolled in the study that received at least 1 dose of study medication. This was the primary population for all efficacy analyses and safety analyses.||participants|||Number
702745|NCT00084266|Secondary|Survival Status Estimated by Kaplan-Meier Analysis for ITT Population|For each participant, time to death was estimated from baseline to date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 days after last dose. The distribution of survival was estimated for the treatment groups using the Kaplan-Meier, product-limit method and compared between the treatment groups using the log rank statistic.|From baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 days after last dose.|ITT population included all participants who received at least one dose of study medication.||Days||Standard Error|Mean
702746|NCT00084266|Secondary|Survival Status Estimated by Kaplan-Meier Analysis for mITT Population|For each participant, time to death was estimated from baseline to date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 days after last dose. The distribution of survival was estimated for the treatment groups using the Kaplan-Meier, product-limit method and compared between the treatment groups using the log rank statistic.|From baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 days after last dose.|mITT population included all ITT participants (who received at least 1 dose of drug) with a diagnosis of nosocomial pneumonia caused by proven MRSA.||Days||Standard Error|Median
702747|NCT00084266|Secondary|Survival Status Estimated by Kaplan-Meier Analysis for PP Population|For each participant, time to death was estimated from baseline to date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 days after last dose. The distribution of survival was estimated for the treatment groups using the Kaplan-Meier, product-limit method and compared between the treatment groups using the log rank statistic.|From baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 days after last dose.|PP population included all mITT participants who satisfied all critical inclusion/exclusion criteria,had adequate dosing of drug (defined as 5 full days for success or 2 full days of treatment for participants whose clinical outcome was considered failure)and had observed outcome for that visit unless already declared failure prior to that visit.||Days||Standard Error|Mean
702748|NCT00084266|Secondary|Number of Participants With Clinical Signs and Symptoms at EOT for mITT Population|Participant’s clinical evaluation of signs and symptoms were based on global assessment by investigator at specific timepoints. Signs and symptoms (mild to severe) of nosocomial pneumonia included cough; production of purulent sputum or change in character of sputum;auscultatory findings on pulmonary examination of rales and/or pulmonary consolidation (dullness on percussion, bronchial breath sounds, or egophony); and dyspnea, tachypnea, or hypoxemia with PaO2 <60 mmHg or worsening gas exchange or increased oxygen requirements; pleuritic chest pain; chills/rigors; and decreased breath sounds.|EOT (within 72 hours of last dose)|mITT population included all ITT participants who received at least 1 dose of drug with a diagnosis of nosocomial pneumonia caused by proven MRSA and had an observed outcome for that visit unless already declared a failure prior to that visit.||Participants|||Number
702749|NCT00084266|Secondary|Number of Participants With Clinical Signs and Symptoms at EOT for PP Population|Participant’s clinical evaluation of signs and symptoms were based on global assessment by investigator at specific timepoints. Signs and symptoms (mild to severe) of nosocomial pneumonia included cough; production of purulent sputum or change in character of sputum;auscultatory findings on pulmonary examination of rales and/or pulmonary consolidation (dullness on percussion, bronchial breath sounds, or egophony); and dyspnea, tachypnea, or hypoxemia with PaO2 <60 mmHg or worsening gas exchange or increased oxygen requirements; pleuritic chest pain; chills/rigors; and decreased breath sounds.|EOT (within 72 hours of last dose)|PP population included all mITT participants who satisfied all critical inclusion/exclusion criteria,had adequate dosing of drug (defined as 5 full days for success or 2 full days of treatment for participants whose clinical outcome was considered failure)and had observed outcome for that visit unless already declared failure prior to that visit.||Participants|||Number
702750|NCT00084266|Secondary|Number of Participants With Clinical Signs and Symptoms at EOS for mITT Population|Participant’s clinical evaluation of signs and symptoms were based on global assessment by investigator at specific timepoints. Signs and symptoms (mild to severe) of nosocomial pneumonia included cough; production of purulent sputum or change in character of sputum;auscultatory findings on pulmonary examination of rales and/or pulmonary consolidation (dullness on percussion, bronchial breath sounds, or egophony); and dyspnea, tachypnea, or hypoxemia with PaO2 <60 mmHg or worsening gas exchange or increased oxygen requirements; pleuritic chest pain; chills/rigors; and decreased breath sounds.|EOS (7-30 days after last dose)|mITT population included all ITT participants who received at least 1 dose of drug with a diagnosis of nosocomial pneumonia caused by proven MRSA and had an observed outcome for that visit unless already declared a failure prior to that visit.||Participants|||Number
702751|NCT00084266|Secondary|Number of Participants With Clinical Signs and Symptoms at EOS for PP Population|Participant’s clinical evaluation of signs and symptoms were based on global assessment by investigator at specific timepoints. Signs and symptoms (mild to severe) of nosocomial pneumonia included cough; production of purulent sputum or change in character of sputum;auscultatory findings on pulmonary examination of rales and/or pulmonary consolidation (dullness on percussion, bronchial breath sounds, or egophony); and dyspnea, tachypnea, or hypoxemia with PaO2 <60 mmHg or worsening gas exchange or increased oxygen requirements; pleuritic chest pain; chills/rigors; and decreased breath sounds.|EOS (7-30 days after last dose)|PP population included all mITT participants who satisfied all critical inclusion/exclusion criteria,had adequate dosing of drug (defined as 5 full days for success or 2 full days of treatment for participants whose clinical outcome was considered failure)and had observed outcome for that visit unless already declared failure prior to that visit.||Participants|||Number
702752|NCT00084266|Secondary|Microbiological Outcome in Participants With Baseline MRSA at EOT for mITT Population|Microbiological response assessed at participant level.Eradication:baseline isolate not present in repeat culture from original infection site;Presumed Eradication:clinical response of cure precluded availability of specimen for culture;Persistence:baseline isolate present in repeat culture;Presumed Persistence:culture data not available for participant with clinical response of failure;Superinfection:culture from primary infection site had new pathogen not identified as baseline isolate and clinical response was failure;Indeterminate:any participant who cannot be classified into any of above.|EOT (within 72 hours of last dose)|mITT population included all ITT participants (who received at least 1 dose of drug) with a diagnosis of nosocomial pneumonia caused by proven MRSA and had an observed outcome for that visit unless already declared a failure prior to that visit.||Participants|||Number
702753|NCT00084266|Secondary|Microbiological Outcome in Participants With Baseline MRSA at EOT for PP Population|Microbiological response assessed at participant level.Eradication:baseline isolate not present in repeat culture from original infection site;Presumed Eradication:clinical response of cure precluded availability of specimen for culture;Persistence:baseline isolate present in repeat culture;Presumed Persistence:culture data not available for participant with clinical response of failure;Superinfection:culture from primary infection site had new pathogen not identified as baseline isolate and clinical response was failure;Indeterminate:any participant who cannot be classified into any of above.|EOT (within 72 hours of last dose)|PP population included all mITT participants who satisfied all critical inclusion/exclusion criteria,had adequate dosing of drug (defined as 5 full days for success or 2 full days of treatment for participants whose clinical outcome was considered failure)and had observed outcome for that visit unless already declared failure prior to that visit.||Participants|||Number
702754|NCT00084266|Secondary|Microbiological Outcome in Participants With Baseline MRSA at EOS for mITT Population|Microbiological response assessed at participant level.Eradication:baseline isolate not present in repeat culture from original infection site;Presumed Eradication:clinical response of cure precluded availability of specimen for culture;Persistence:baseline isolate present in repeat culture;Presumed Persistence:culture data not available for participant with clinical response of failure;Superinfection:culture from primary infection site had new pathogen not identified as baseline isolate and clinical response was failure;Indeterminate:any participant who cannot be classified into any of above.|EOS (7-30 days after last dose)|mITT population included all ITT participants (who received at least 1 dose of drug) with a diagnosis of nosocomial pneumonia caused by proven MRSA and had an observed outcome for that visit unless already declared a failure prior to that visit.||Participants|||Number
702755|NCT00084266|Secondary|Microbiological Outcome in Participants With Baseline MRSA at EOS for PP Population|Microbiological response assessed at participant level.Eradication:baseline isolate not present in repeat culture from original infection site;Presumed Eradication:clinical response of cure precluded availability of specimen for culture;Persistence:baseline isolate present in repeat culture;Presumed Persistence:culture data not available for participant with clinical response of failure;Superinfection:culture from primary infection site had new pathogen not identified as baseline isolate and clinical response was failure;Indeterminate:any participant who cannot be classified into any of above.|EOS (7-30 days after last dose)|PP population included all mITT participants who satisfied all critical inclusion/exclusion criteria,had adequate dosing of drug (defined as 5 full days for success or 2 full days of treatment for participants whose clinical outcome was considered failure)and had observed outcome for that visit unless already declared failure prior to that visit.||Participants|||Number
702756|NCT00084266|Secondary|Clinical Outcome in Participants With Baseline MRSA at EOT for mITT Population|Clinical response evaluated at EOT visit as Cure:resolution of clinical sign/symptoms of pneumonia when compared with baseline;Improvement: in 2 or more clinical sign/symptoms of pneumonia when compared with baseline,improvement/lack of progression of all chest X-ray abnormalities,Failure: persistence/ progression of baseline signs/symptoms of pneumonia or baseline radiographic abnormalities after atleast 2 days of treatment; development of new pulmonary/extrapulmonary clinical findings consistent with active infection;Unknown: extenuating circumstances precluding classification to 1 of above.|EOT (within 72 hours of last dose)|mITT population included all ITT participants who received at least 1 dose of drug with a diagnosis of nosocomial pneumonia caused by proven MRSA and had an observed outcome for that visit unless already declared a failure prior to that visit.||Participants|||Number
702757|NCT00084266|Secondary|Clinical Outcome in Participants With Baseline MRSA at End of Treatment (EOT) for PP Population|Clinical response evaluated at EOT visit as Cure:resolution of clinical sign/symptoms of pneumonia when compared with baseline;Improvement: in 2 or more clinical sign/symptoms of pneumonia when compared with baseline,improvement/lack of progression of all chest X-ray abnormalities,Failure: persistence/ progression of baseline signs/symptoms of pneumonia or baseline radiographic abnormalities after atleast 2 days of treatment; development of new pulmonary/extrapulmonary clinical findings consistent with active infection;Unknown: extenuating circumstances precluding classification to 1 of above.|EOT (within 72 hours of last dose)|PP population included all mITT participants who satisfied all critical inclusion/exclusion criteria,had adequate dosing of drug (defined as 5 full days for success or 2 full days of treatment for participants whose clinical outcome was considered failure)and had observed outcome for that visit unless already declared failure prior to that visit.||Participants|||Number
703677|NCT00095498|Secondary|Change From Baseline in Basophils at Month 6|Laboratory hematology basophils|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.||* 10^9/L||Standard Deviation|Mean
702758|NCT00084266|Secondary|Clinical Outcome in Participants With Baseline MRSA at EOS for mITT Population|Clinical response was based primarily on global assessment of clinical presentation of participant made by investigator at evaluation timepoint. Clinical response was evaluated at EOS Visit as Cure: resolution of clinical signs/symptoms of pneumonia when compared with baseline; Failure: persistence/progression of baseline signs/symptoms of pneumonia or baseline radiographic abnormalities after atleast 2 days of treatment; development of new pulmonary/extrapulmonary clinical findings consistent with active infection; Unknown:extenuating circumstances precluding classification to 1 of the above.|EOS (7-30 days after last dose)|mITT population included all ITT participants who received at least 1 dose of drug with a diagnosis of nosocomial pneumonia caused by proven MRSA and had an observed outcome for that visit unless already declared a failure prior to that visit.||Participants|||Number
702759|NCT00084266|Primary|Clinical Outcome in Participants With Baseline Methicillin Resistant Staphylococcus Aureus (MRSA) at End of Study (EOS) for PP Population|Clinical response was based primarily on global assessment of clinical presentation of participant made by investigator at evaluation timepoint. Clinical response was evaluated at EOS Visit as Cure: resolution of clinical signs/symptoms of pneumonia when compared with baseline; Failure: persistence/progression of baseline signs/symptoms of pneumonia or baseline radiographic abnormalities after atleast 2 days of treatment; development of new pulmonary/extrapulmonary clinical findings consistent with active infection; Unknown:extenuating circumstances precluding classification to 1 of the above.|EOS (7-30 days after last dose)|PP population included all mITT participants who satisfied all critical inclusion/exclusion criteria,had adequate dosing of drug (defined as 5 full days for success or 2 full days of treatment for participants whose clinical outcome was considered failure) and had observed outcome for that visit unless already declared failure prior to that visit.||Participants|||Number
702760|NCT00084318|Secondary|Correlation of EGFR (Total and Phosphorylated) pMAPK, pAKT, Stat-3, KI-67, COX-2, and Cyclin B1 Expression With Local-regional Control, and Overall and Disease-free Survival|Biomarker data has not yet been obtained and therefore this outcome measure cannot yet be reported.|From randomization to two years||||||
702761|NCT00084318|Secondary|Local-regional Control|Two-year rate is shown (cumulative incidence estimate). Local-regional failure is defined as the time from randomization to local-regional recurrence (event), death (competing risk), or last follow-up (censored).|From randomization to 2 years|Eligible patients who started protocol treatment and did not withdraw consent.||percentage of participants||95% Confidence Interval|Number
702762|NCT00084318|Secondary|Frequency of Other Acute and Late Toxicity|Maximum grade toxicity that is definitely, probably, or possibly related to protocol treatment.|From start of treatment to last follow-up. Analysis occurs at the time of the primary endpoint analysis.|Eligible patients who started protocol treatment and did not withdraw consent||percentage of participants|||Number
702763|NCT00084318|Secondary|Frequency of Toxicity (Grade 5 and Acute Non-hematologic Grade 4)|Each regimen was monitored for excessive acute toxicity (defined as nonhematologic grade 4 toxicity within 90 days of the start of radiation or any grade 5 toxicity). The target rate was based on the observed rate from RTOG-9501/NCT00002670 of 15%. The unacceptable rate was >30%. [RTOG = Radiation Therapy Oncology Group]|From start of treatment to last follow-up. Analysis occurs at the time of the primary analysis.|Eligible patients who started protocol treatment and did not withdraw consent||percentage of participants||95% Confidence Interval|Number
702764|NCT00084318|Secondary|Treatment Tolerance|Tolerability was defined as having received 90% of the radiation dose, 95% of the cetuximab loading dose, and at least 4 weeks of cetuximab and cisplatin or docetaxel at doses 95% of the protocol prescription. The percentage of patients determined to be tolerant of treatment are shown.|From start of treatment to end of treatment (protocol treatment lasts seven weeks).|Eligible patients who started protocol treatment and did not withdraw consent||percentage of participants||95% Confidence Interval|Number
702765|NCT00084318|Secondary|Overall Survival|Two-year rates are shown (Kaplan-Meier estimates). Overall survival is defined as the time from randomization to death (event) or last follow-up (censored).|From randomization to 2 years|Eligible patients who started protocol treatment and did not withdraw consent||percentage of participants||95% Confidence Interval|Number
702766|NCT00084318|Primary|Disease-free Survival|Two-year rates are shown (Kaplan-Meier estimates). Disease-free survival is defined as the time from randomization to local, regional, or distant progression, second primary, or death (event) or last follow-up (censored). Response criteria as follows: No evidence of disease (NED): All patients must have no measurable tumor following surgery; Local-Regional Relapse: Recurrent cancer in the tumor bed and/or neck not clearly attributable to a second primary neoplasm; biopsy confirmation is necessary; Distant Relapse: Clear evidence of distant metastases (lung, bone, brain, etc.); Biopsy is recommended where possible. A solitary lung mass/nodule is considered a second primary neoplasm unless proven otherwise.|From randomization to 2 years|Eligible patients who started protocol treatment and did not withdraw consent.||percentage of participants||95% Confidence Interval|Number
702767|NCT00084383|Primary|Disease-free Survival|Disease-free Survival in Patients Treated With Adjuvant Chemoradiotherapy in Sequence With the Irradiated Allogeneic GM-CSF Transfected Pancreatic Tumor Cell Lines. DFS is defined as time from surgery until clinical evidence of disease (eg, CT scan) or death due to any cause.|Participants were followed for the duration of the study, an average of 2 years|||Months||95% Confidence Interval|Median
702768|NCT00084383|Secondary|Estimate the Association of Specific in Vivo Parameters of Immune Response With Clinical Responses in Patients Treated With Combination Chemoradiotherapy Together With the Irradiated Allogeneic GM-CSF Transfected Pancreatic Tumor Cell Lines.|The specific immune parameters include: post-vaccination delayed type hypersensitivity reactions to autologous tumor and the degree of local eosinophil, macrophage, and T cell infiltration at the vaccine site, and mesothelin-specific T cell responses.|Continuous||||||
702769|NCT00084383|Secondary|To Further Identify and Characterize Toxicities Associated With Intradermal Injections of the Vaccine That Were Initially Reported in the Phase 1 Trial.||4 years||||||
702770|NCT00084383|Primary|Overall Survival|Overall survival in patients treated with adjuvant chemoradiotherapy in sequence with the irradiated allogeneic GM-CSF transfected pancreatic tumor cell lines. Overall survival is defined as time from surgery until death, regardless of cause.|Participants were followed for the duration of the study, an average of 2 years|||Months||95% Confidence Interval|Median
728676|NCT00369278|Secondary|Rates of Events for Treated Acute Rejection, Death, Graft Loss, or Loss to Follow up on Day 28, Day 84, and Day 180|Due to a small number of events, median time to <event> was not reached.|6 months||||||
702771|NCT00084409|Secondary|Change in Dysplasia Index (Follow-up - Baseline) Using Baseline Non-Normal Pairs|"This outcome measure is created for each subject as follows:
The biopsies used in this analysis are restricted to biopsies from anatomical sites that were biopsies during both the baseline and follow-up bronchoscopies, thus creating pairs of biopsies. Any pair for which the baseline WHO score was 1 (i.e. normal tissue) was excluded from the analysis.
From these biopsies scored at the baseline bronchoscopy, the percentage with a WHO score greater than or equal to 4 is calculated (this is the definition of Dysplasia Index (DI)).
From these biopsies scored at the follow-up bronchoscopy, the percentage with a WHO score greater than or equal to 4 is calculated.
The difference (follow-up DI - baseline DI) is used as the outcome measure for each subject."|9 Years|The analysis was restricted to the 107 subjects (52 in the iloprost group, 55 in the placebo group) with at least 1 non-normal biopsy at baseline, thereby excluding the 18 subjects (8 in the iloprost group and 10 in the placebo group) who had only normal biopsy tissue at baseline.||Percentage points||Standard Deviation|Mean
702772|NCT00084409|Secondary|Change in Maximum (Follow-up - Baseline) Using Baseline Non-Normal Pairs|"This outcome measure is created for each subject as follows:
The biopsies used in this analysis are restricted to biopsies from anatomical sites that were biopsies during both the baseline and follow-up bronchoscopies, thus creating pairs of biopsies. Any pair for which the baseline WHO score was 1 (i.e. normal tissue) was excluded from the analysis.
From these biopsies scored at the baseline bronchoscopy, the maximum WHO score is used.
From these biopsies scored at the follow-up bronchoscopy, the maximum WHO score is used.
The difference (follow-up maximum - baseline maximum) is used as the outcome measure for each subject."|9 Years|The analysis was restricted to the 107 subjects (52 in the iloprost group, 55 in the placebo group) with at least 1 non-normal biopsy at baseline, thereby excluding the 18 subjects (8 in the iloprost group and 10 in the placebo group) who had only normal biopsy tissue at baseline.||WHO Units||Standard Deviation|Mean
702773|NCT00084409|Secondary|Change in Average (Follow-up - Baseline) Using Baseline Non-Normal Pairs|"This outcome measure is created for each subject as follows:
The biopsies used in this analysis are restricted to biopsies from anatomical sites that were biopsies during both the baseline and follow-up bronchoscopies, thus creating pairs of biopsies. Any pair for which the baseline WHO score was 1 (i.e. normal tissue) was excluded from the analysis.
From these biopsies scored at the baseline bronchoscopy, the mean WHO score is calculated.
From these biopsies scored at the follow-up bronchoscopy, the mean WHO score is calculated.
The difference (follow-up mean - baseline mean) is used as the outcome measure for each subject."|9 Years|The analysis was restricted to the 107 subjects (52 in the iloprost group, 55 in the placebo group) with at least 1 non-normal biopsy at baseline, thereby excluding the 18 subjects (8 in the iloprost group and 10 in the placebo group) who had only normal biopsy tissue at baseline.||WHO Units||Standard Deviation|Mean
702774|NCT00084409|Secondary|Change in Dysplasia Index (Follow-up - Baseline) Using Matched Sites|"This outcome measure is created for each subject as follows:
The biopsies used in this analysis are restricted to biopsies from anatomical sites that were biopsies during both the baseline and follow-up bronchoscopies.
From these biopsies scored at the baseline bronchoscopy, the percentage with a WHO score greater than or equal to 4 is calculated (this is the definition of Dysplasia Index (DI)).
From these biopsies scored at the follow-up bronchoscopy, the percentage with a WHO score greater than or equal to 4 is calculated.
The difference (follow-up DI - baseline DI) is used as the outcome measure for each subject."|9 Years|||Percentage points||Standard Deviation|Mean
702775|NCT00084409|Secondary|Change in Maximum (Follow-up - Baseline) Using Matched Sites|"This outcome measure is created for each subject as follows:
The biopsies used in this analysis are restricted to biopsies from anatomical sites that were biopsies during both the baseline and follow-up bronchoscopies.
From these biopsies scored at the baseline bronchoscopy, the maximum WHO score is used.
From these biopsies scored at the follow-up bronchoscopy, the maximum WHO score is used.
The difference (follow-up maximum - baseline maximum) is used as the outcome measure for each subject."|9 Years|||WHO Units||Standard Deviation|Mean
702776|NCT00084409|Secondary|Change in Average (Follow-up - Baseline) Using Matched Sites|"This outcome measure is created for each subject as follows:
The biopsies used in this analysis are restricted to biopsies from anatomical sites that were biopsies during both the baseline and follow-up bronchoscopies, thus creating pairs of biopsies.
From these biopsies scored at the baseline bronchoscopy, the mean WHO score is calculated.
From these biopsies scored at the follow-up bronchoscopy, the mean WHO score is calculated.
The difference (follow-up mean - baseline mean) is used as the outcome measure for each subject."|9 Years|||WHO Units||Standard Deviation|Mean
702777|NCT00084409|Secondary|Change in Dysplasia Index (Follow-up - Baseline) Using Reference Sites|"This outcome measure is created for each subject as follows:
The biopsies used in this analysis are those from the following 6 anatomical sites pre-specified in the protocol to be biopsied: RUL, RML, RB6, LUL, LUDB, and LB6.
From these biopsies scored at the baseline bronchoscopy, the percentage with a WHO score greater than or equal to 4 is calculated (this is the definition of Dysplasia Index (DI)).
From these biopsies scored at the follow-up bronchoscopy, the percentage with a WHO score greater than or equal to 4 is calculated.
The difference (follow-up DI - baseline DI) is used as the outcome measure for each subject."|9 Years|||Percentage points||Standard Deviation|Mean
702778|NCT00084409|Secondary|Change in Maximum (Follow-up - Baseline) Using Reference Sites|"This outcome measure is created for each subject as follows:
The biopsies used in this analysis are those from the following 6 anatomical sites pre-specified in the protocol to be biopsied: RUL, RML, RB6, LUL, LUDB, and LB6.
From these biopsies scored at the baseline bronchoscopy, the maximum WHO score is used.
From these biopsies scored at the follow-up bronchoscopy, the maximum WHO score is used.
The difference (follow-up maximum - baseline maximum) is used as the outcome measure for each subject."|9 Years|||WHO Units||Standard Deviation|Mean
702794|NCT00088153|Secondary|Change in N-terminal Propeptide of Type 1 Procollagen (P1NP) Over the Study Duration (18 Months)|"P1NP is a surrogate marker of bone formation that is measured in serum. P1NP levels were measured at baseline, 6, 12 and 18 months.
A secondary outcome was the change in P1NP levels from baseline to 18 months: [P1NP at 18 months - P1NP at baseline). The unit is ng/ml"|Baseline and 18 months|The number of participants was determined based on our preliminary data. This analysis was based on completers only.||ng/ml||Standard Deviation|Mean
703201|NCT00081263|Primary|Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 3.0|Number of participants with a grade of 3 or higher during the treatment period.|Assessed every cycle while on treatment, 30 days after the last cycle of treatment|Eligible and treated patients.||participants|||Number
702779|NCT00084409|Secondary|Change in Average (Follow-up - Baseline) Using Reference Sites|"This outcome measure is created for each subject as follows:
The biopsies used in this analysis are those from the following 6 anatomical sites pre-specified in the protocol to be biopsied: RUL (Right upper lobe: the superior region of the right lung), RML (Right middle lobe: an anatomic portion of the right lung), RB6 (The carina in the right lower lobe at the entrance to the superior segment), LUL (Left upper lobe: the superior portion of the lung), LUDB (Left upper division bronchus: the carina between the lingular orifice and the left upper lobe), and LB6 (The carina in the left lower lobe at the entrance to the superior segment).
From these biopsies scored at the baseline bronchoscopy, the mean WHO score is calculated.
From these biopsies scored at the follow-up bronchoscopy, the mean WHO score is calculated.
The difference (follow-up mean - baseline mean) is used as the outcome measure for each subject."|9 Years|||WHO Units||Standard Deviation|Mean
702780|NCT00084409|Secondary|Change in Dysplasia Index (Follow-up - Baseline) Using All Biopsies|"This outcome measure is created for each subject as follows:
From all biopsies scored at the baseline bronchoscopy, the percentage with a WHO score greater than or equal to 4 is calculated (this is the definition of Dysplasia Index (DI)).
From all biopsies scored at the follow-up bronchoscopy, the percentage with a WHO score greater than or equal to 4 is calculated.
The difference (follow-up DI - baseline DI) is used as the outcome measure for each subject."|9 Years|||Percentage points||Standard Deviation|Mean
702781|NCT00084409|Secondary|Change in Maximum (Follow-up - Baseline) Using All Biopsies|"This outcome measure is created for each subject as follows:
From all biopsies scored at the baseline bronchoscopy, the maximum WHO score is used.
From all biopsies scored at the follow-up bronchoscopy, the maximum WHO score is used.
The difference (follow-up maximum - baseline maximum) is used as the outcome measure for each subject."|9 Years|||WHO Units||Standard Deviation|Mean
702782|NCT00084409|Other Pre-specified|Define the Genes Whose Expression is Altered by Iloprost Treatment by Gene Expression Arrays and Quantitative PCR.||Nine Years||||||
702783|NCT00084409|Other Pre-specified|To Determine the Toxicity Profile of Iloprost in Patients at High Risk to Develop Lung Cancer.||Nine Years||||||
702784|NCT00084409|Other Pre-specified|To Determine Whether Iloprost Affects Prostaglandin Metabolism by Examining 4 Markers, PGIS, COX-2, PPAR and PPAR.|PGIS (Prostacyclin synthase: an enzyme in the eicosanoid pathway that catalyzes the conversion of prostaglandin H2 to prostaglandin I2 (prostacyclin). PPAR (Peroxisome proliferator-activated receptor: a group of nuclear receptor proteins that act as transcription factors regulating gene expression),|Nine years||||||
702785|NCT00084409|Other Pre-specified|To Determine if Iloprost Can Modulate K-67 Proliferation Index in Patients at High Risk to Develop Lung Cancer||nine years||||||
702786|NCT00084409|Secondary|To Determine Whether Iloprost Can Modulate a Panel of Biomarkers Including MCM-1 EGFR Mutations in Egfr Expression or Activity Can Result in Cancer), Her-2/Neu, RAR, p53 FHIT, Apoptotic Index, and Microvessel Density.|MCM (Minichromosome maintenance protein: forms DNA helicase), EGFR (Epidermal growth factor receptor: cell surface receptor for the epidermal growth factor family of proteins. Mutations in egfr expression or activity can result in cancer). RAR (Retinoic Acid Receptor Beta is a nuclear transcription regulator and a member of the thyroid-steroid hormone receptor superfamily).FHIT (Fragile histidine triad protein is an enzyme involved in purine metabolism and had been demonstrated to be a tumor suppressor).|Nine years||||||
702787|NCT00084409|Primary|Change in Average (Follow-up - Baseline) From All Biopsies|"This outcome measure is created for each subject as follows:
From all biopsies scored at the baseline bronchoscopy, the mean WHO score is calculated.
From all biopsies scored at the follow-up bronchoscopy, the mean WHO score is calculated.Histology on bronchial biopsies pre-treatment and post-treatment will be compared. All biopsies will be graded according to the WHO classification for bronchial epithelium for this outcome, and all the following outcomes.
WHO Classification Grade Normal 1.0 Reserve Cell Hyperplasia 2.0 Metaplasia 3.0 Mild Dysplasia 4.0 Moderate Dysplasia 5.0 Severe Dysplasia 6.0 Carcinoma in Situ 7.0 Carcinoma 8.0
The difference (follow-up mean - baseline mean) is used as the outcome measure for each subject."|Nine years|||WHO Units||Standard Deviation|Mean
702788|NCT00084487|Secondary|Overall Survival|Percentage of patients alive at 1 year|1 year|Intent to treat||percentage of participants||95% Confidence Interval|Number
702789|NCT00084487|Secondary|Progression Free Survival|Percentage of patients that are progression free at 6 months.|6 months|Intent to treat||percentage of participants||95% Confidence Interval|Number
702790|NCT00084487|Primary|Overall Survival|Median time of patient survival. Duration of survival will be analyzed using Kaplan-Meier curves.|Up to 4 years|Intent to treat||months||95% Confidence Interval|Median
702791|NCT00084487|Primary|Progression Free Survival|Median time of patients without Progressive Disease (PD):At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Duration of remission will be analyzed using Kaplan-Meier curves.|Up to 4 years|Intent to treat||months||95% Confidence Interval|Median
702792|NCT00084487|Primary|Objective Response Rate Estimated as the Proportion of Responders|"Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD):At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD):Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
An exact binomial 95% confidence interval will be calculated for this proportion."|Up to 4 years|Intent to treat||participants|||Number
702793|NCT00088153|Primary|Change in Spine Bone Mineral Density Z-scores Over the Study Duration (18 Months)|"Bone density at the spine (lumbar 1-4 vertebrae) was measured using dual energy x-ray absorptiometry (DXA) at baseline, 6 months, 12 months and 18 months.
The other primary outcome was the change in spine bone density Z-score from baseline to 18 months. The bone density Z-score is a standard deviation score that compares one's bone density to the mean for age and gender, and the Z-score, therefore, does not have any units. It is simply referred to as a Z-score. Change in bone density Z-score= [Bone density Z-score at 18 months- Bone density Z-score at baseline]"|Baseline and 18 months|||Z -scores||Standard Deviation|Mean
702795|NCT00088153|Primary|Percent Change in Spine Bone Density Over the Study Duration (18 Months)|"Bone density at the spine (lumbar 1-4 vertebrae) was measured using dual energy x-ray absorptiometry (DXA) at baseline, 6 months, 12 months and 18 months.
The primary outcome was the percent change in bone density at the spine from baseline to 18 months. Areal bone density is measured as g/cm2. The unit of measure for the percent change in bone density is 'percent' Percent change in bone density= [[Bone density at 18 months- Bone density at baseline)*100/Bone density at baseline]%"|Baseline and 18 months|The number of participants was determined using power calculations based on preliminary data. For our primary longitudinal analysis, bone mineral density (BMD) changes were analyzed using a mixed model analysis of variance (intent-to-treat model). For secondary analysis, we examined BMD changes after controlling for age and weight changes.||Percent change||Standard Deviation|Mean
702796|NCT00088166|Secondary|Number of Patients Who Discontinued Study Drug Prior to the End of Week 5|Numbers of patients who discontinued prior to the Week 5 assessment|Prospective|Intent to Treat population||participants|||Number
702797|NCT00088166|Secondary|Maximum Percent Reduction in Dexamethasone Usage Relative to Baseline Achieved During the Study|The maximum reduction in dexamethasone usage at any time during the study. Dexamethasone dosage was assessed at Weeks 0, 2, 5, 8, 12 and 16.|Prospective|Intent to Treat population; baseline observation carried forward||Percent dexamethasone dose reduction||Standard Deviation|Mean
702798|NCT00088166|Secondary|Change From Baseline in Myopathy Assessment Results at Week 12 (or Early Study Drug Discontinuation) and Week 16 (or 4-week Follow-up Visit)|Myopathy, using Kendall Myopathy Scale, was assessed at Baseline, Week 12 (or upon Early SDD), and at the post-treatment 4-week follow-up visit (Week 16 and/or any unscheduled 4-week Follow-up). The Kendall Myopathy Scale is a 10 point scale where 10 represents holding test position against strong pressure (best) and 0 represents no contraction palpable (worst).|Prospective|||Scores on a scale||Standard Deviation|Mean
702799|NCT00088166|Secondary|Change From Baseline in the FACT-Br Quality of Life Results|The FACT-Br Quality of Life Questionnaire was self-administered at Baseline, Weeks 5 and 12 (or upon Early SDD), and at the post-treatment 4-week follow-up visit (Week 16 and/or any unscheduled 4-week Follow-up).FACT-Br is a reliable and valid 50-item measure that includes FACT-G (27 items) and a brain subscale (23 items) to assess health-related quality of life in brain tumor patients. Each inventory question is scored from 0 (worst possible QOL) to 4 (best possible QOL)|Prospective|Intent to Treat; LOCF||Scores on a scale||Standard Deviation|Mean
702800|NCT00088166|Secondary|Change From Baseline in the Karnofsky Performance Score|"Change from Baseline in the Karnofsky Performance Score at Weeks 2, 5, 8, 12 and 16.The Karnofsky score runs from 100 to 0, where 100 is perfect health and 0 is death. Although practitioners occasionally assign performance scores in between standard intervals of 10 as follows:
100 - Normal; no complaints; no evidence of disease. 90 - Able to carry on normal activity; minor signs or symptoms of disease. 80 - Normal activity with effort; some signs or symptoms of disease. 70 - Cares for self; unable to carry on normal activity or to do active work. 60 - Requires occasional assistance, but is able to care for most of his personal needs.
50 - Requires considerable assistance and frequent medical care. 40 - Disabled; requires special care and assistance. 30 - Severely disabled; hospital admission is indicated although death not imminent.
20 - Very sick; hospital admission necessary; active supportive treatment nec"|Prospective|Intent to Treat population||Scores on a scale||Standard Deviation|Mean
702801|NCT00088166|Secondary|Change From Baseline in the 10-Item Neurological Examination Score at Weeks 2, 5, 8 12 and 16 (or Early Discontinuation)|Change from Baseline in the 10-Item Neurological Examination Score at Weeks 2, 5, 8, 12 (or Early Study Drug Discontinuation), and 16 (or 4-week follow-up visit). Each item is scored from 0 (normal) to 4 (severely abnormal) except for speech (0-3) for a total range of 0-39. Total score for each patient was the sum of each item score. Change is calculated as the follow-up score minus the baseline score; a negative value indicates improvement.|Prospective|Intent to Treat population||Scores on a scale||Standard Deviation|Mean
702802|NCT00088166|Secondary|The Proportion of Patients in Each Treatment Group Who Are Responders at Week 2 and Who Continue to be Responders at Weeks 5 and 8|• The proportion of patients in each treatment group who were Responders at Week 2 and who continued to be Responders at Weeks 5 and 8.|Prospective|Intent to Treat Population||participants|||Number
702803|NCT00088166|Secondary|Percent of Patients in Each Treatment Group Achieving 50% Reduction in Dexamethasone Usage Relative to Baseline by Week 2 Without Deterioration in Neurological Function as Measured by the 10-Item Neurological Exam and the KPS||Prospective|Intent to Treat Population||participants|||Number
702804|NCT00088166|Primary|The Proportion of Patients in Each Treatment Group Who Are Responders at Week 2 and Continue to be Responders at Week 5|"The primary efficacy endpoint was the proportion of patients in each treatment group who were Responders at Week 2 and who continued to be Responders at Week 5. Responders were defined as study patients who demonstrated the following:
50% or greater reduction in dexamethasone dose relative to Baseline
Overall 10-Item Neurological Examination Score unchanged or lower compared to Baseline
Karnofsky Score unchanged or increased relative to Baseline"|Prospective|Intent to Treat Population||participants|||Number
702805|NCT00088218|Primary|Number of Participants With Response|"Participant responses are categorized as 'Complete Remission,' Complete Remission, No Platelet Recovery,' 'No Response.'
Complete Remission: Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count > 1.0 x 109/L and platelet count > 100 x 109/L, and normal bone marrow differential (< 5% blasts); Complete Remission, No Platelet Recovery: Peripheral blood and bone marrow results as for CR, but with platelet counts of < 100 x 109/L.
Blood draws once a week until remission then every 2 to 8 weeks during therapy."|Every 2 to 8 weeks|All treated subjects.||Participants|||Number
702806|NCT00088374|Secondary|Number of Participants With Flow Dynamics Measured by DCE MRI Within the Renal and Non-renal Tumor|Dynamic images will be acquired before and after the intravenous administration of 0.1 mmol/kg of Gadolinium Diethylene triamine pentaacetic acid (DTPA). Time activity curves will be generated over a period of ten minutes. The parameter to be measured is the forward contrast transfer rate (Ktrans), the reverse contrast transfer rate (Kep), and/or the extravascular extracellular space volume fraction (Ve). Flow dynamics are a measure of blood flow changes in the tumor and are determined using the parameters we had previously defined (Ktrans, Kep, etc.).|Baseline and during therapy (12 weeks)|It is not the magnitude of changes in Ktrans, Kep, and Ve that limit our abililty, but the fact that this data was available in only a small number of patients.||participants with changes|||Number
702807|NCT00088374|Secondary|Number of Patients in Whom Renal Tumors Could be Identified by Positron Emission Tomography (PET)Based on Fludeoxyglucose 18F (18FDG) Uptake|Images were acquired after the intravenous administration of 18FDG and H2015 and used to analyze glucose uptake and estimate blood flow. The parameter to be measured is SUV (standard uptake value(s)) and/or mL/min/gm.|Baseline and at 12 weeks|Response was not the endpoint. The SUV values were in the 2-3 range and hence renal tumors could not be clearly identified by this technique in any of the patients.||participants|||Number
702808|NCT00088374|Secondary|The Number of Participants With HIF, HSP90, and HSP70 Modulation in Resected Tumor Tissue and/or Peripheral Blood Lymphocytes|Measurement of HIF, HSP90 and HSP70 levels by Western Blot in tumor tissue and/or lymphocytes to assess modulation of these biomarkers in response to 17 AAG treatment. Pretreatment tumor samples (when available) and resected tumors (in those patients who did not have a response and underwent surgical resection of their tumor) were to be used for this analysis. Levels of Hsp90, Hsp70, HIF and HIF transcriptional targets in resected tumor will be compared to respective levels in tumors previously resected from other VHL patients (not treated with 17AAG).|Baseline and 12 weeks|This analysis was not performed as it was felt that there were not a sufficient number of samples to enable a meaningful analysis.|||||
702809|NCT00088374|Secondary|The Number of Participants With Adverse Events|"Here are the total number of participants with adverse events. For the detailed list of adverse events see the adverse event module.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for adverse event reporting. For a detailed description see the link in the Protocol Link module."|1 yr, 364 days|||participants|||Number
702810|NCT00088374|Secondary|Number of Participants With a Non-renal Tumor Response|Number of patients who have a PR or CR of non-renal lesions (pancreatic tumors, pheochromocytomas, and hemangioblastomas). The effect of treatment on the lesions will be evaluated at baseline and at the time of restaging (12 weeks) per RECIST criteria. RECIST is defined as changes in only the largest diameter (unidimensional measurement) of the tumor lesions. Lesions are either measurable or non-measurable using the criteria. See the protocol Link module for the full criteria if desired.|Baseline and 12 weeks|There were only two patients with measurable nonrenal tumors and hence the number of participants analyzed is correct.||participants|||Number
702811|NCT00088374|Primary|Number of Participants With a Renal Tumor Response|Response is defined as the number of patients who experience a disease response (complete response (CR) or partial response (PR) of renal tumors)per RECIST criteria. CR is the disappearance of all target lesions. PR is at least a 20% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. See the protocol Link module for the full criteria if desired.|12 weeks|8 patients were evaluable (received at least one dose of drug and had a follow up scan).||participants|||Number
702812|NCT00088465|Primary|Number of Participants With Extrapyramidal Symptoms at Any Time|Extrapyramidal symptoms are defined as Simpson-Angus total score (SAS) >3 at any post-baseline visit; Barnes Akathisia Scale (BAS) global score ≥2 at any post-baseline visit; A score ≥3 for any of Abnormal Involuntary Movement Scale (AIMS) for items 1-7 or a score ≥2 for any two of these items. Score for SAS is 0-4 for each of the 10 questions, with 0=normal and 4=extreme. The possible total score for SAS is 0-40. Possible score for BAS is 0-5, with 0=absent and 5=sever. Score 0-4 for each item of AIMS, with 0 =none and 4= sever. Possible total score for items 1-7 is 0-28.|Randomization to end of study up to 76 months|Participants with a baseline and at least one post-baseline measurement.||participants|||Number
702813|NCT00088465|Primary|Number of Participants With Potentially Clinically Significant (PCS) Weight Gain at Month 76 Endpoint|PCS weight gain is defined as a ≥7% increase in weight from baseline.|Randomization to end of study up to 76 months|Participants with normal baseline and at least one post-baseline measurement.||participants|||Number
702814|NCT00088465|Primary|Change From Baseline in Weight at Month 76 Endpoint|Mean change in weight from baseline to last observation carried forward (LOCF) endpoint.|Baseline, up to 76 months|Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).||kilogram (kg)||Standard Deviation|Mean
702815|NCT00088465|Primary|Number of Participants Having Normal Fasting Baseline Lipid Value With Treatment-Emergent High Fasting Lipid at Any Time Post Baseline|Normal to high fasting total cholesterol ≤200 mg/dL at baseline to ≥240 mg/dL any time post baseline. Fasting triglycerides <150 mg/dL at baseline to ≥200 mg/dL and <500 mg/dL any time post baseline.|Randomization to end of study up to 76 months|Participants with normal baseline and at least one post-baseline measurement.||participants|||Number
702816|NCT00088465|Primary|Number of Participants Having Normal Fasting Baseline Glucose Value With Treatment-Emergent High Fasting Glucose at Any Time Post Baseline|Normal to high fasting glucose ≤100 milligrams per deciliter (mg/dL) at baseline to ≥126 mg/dL any time post baseline.|Randomization to end of study up to 76 months|Participants with normal baseline and at least one post-baseline measurement.||participants|||Number
702817|NCT00088465|Primary|Number of Participants With Treatment-Emergent Abnormal High Alanine Transaminase (ALT), High Aspartate Transaminase (AST), High Total Bilirubin at Any Time Post Baseline|High ALT is defined as a baseline value of <3 times the upper limit of normal (ULN) to ≥3 times the ULN at any time post baseline. High AST is defined as a baseline value of <5 times the ULN to ≥5 times the ULN at any time post baseline. High total bilirubin is defined as a baseline value of <2 times the ULN to ≥2 times the ULN at any time post baseline.|Randomization to end of study up to 76 months|Participants with normal baseline and at least one post-baseline measurement.||participants|||Number
702818|NCT00088465|Primary|Number of Participants With Treatment-Emergent Abnormal High Prolactin at Any Time Post Baseline|Prolactin normal reference ranges for female: 2.0 - 29.0 nanograms per milliliter (ng/mL); male: 2.0 - 20.0 ng/mL. High value is defined as a change from a value less than or equal to the high limit at all baseline visits to a value greater than the high limit at any time after baseline.|Randomization to end of study up to 76 months|Participants with normal baseline and at least one post-baseline measurement.||participants|||Number
702819|NCT00088465|Secondary|Plasma Olanzapine Concentrations in Participants During Long-Term Treatment by Year|Plasma olanzapine concentrations are expressed as (nanogram/milliliter)/(milligram/day) ([ng/mL]/[mg/day]).|Randomization to end of study up to 76 months|Participants who took at least one dose of study drug and had post-baseline measurements.||(ng/mL)/(mg/day)||Standard Deviation|Mean
729268|NCT00388947|Primary|Count of Patients With at Least One Adverse Event Related to Any AMS Prolapse Device||up to 2-years post-implant|All patients that met the inclusion/exclusion criteria.||participants|||Number
702820|NCT00088465|Secondary|Patient Satisfaction With Medication Questionnaire-Modified (PSMQ) at Month 76 Endpoint|Self-rated scale that measures patient's level of satisfaction with current antipsychotic medication. Consists of 3 items assessing satisfaction with current study medication (scored from 1='very dissatisfied' to 5='very satisfied'), preference comparing current study medication versus previous medications (scored from 1='much prefer previous medication' to 5='much prefer study medication'), and side effects of current study medication compared with previous medications (scored from 1='much less side effects' to 5='much more side effects'). Range of possible scores is 3-15.|Randomization to end of study up to 76 months|All randomized participants.||percent of participants|||Number
702821|NCT00088465|Secondary|Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment-Short Form (SWN-S) at Month 76 Endpoint|The Subjective Well-Being under Neuroleptic Treatment-Short Form (SWN-S) is a patient self-rated scale developed to measure the subjective well-being for the previous 7 days of a patient under neuroleptic treatment. The SWN-S consists of 20 items (each item is rated from 1=not at all to 6=very much). Possible total score ranges from 20-120.|Baseline, up to 76 months|Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
702822|NCT00088465|Secondary|Days of Hospitalization|This is the total number of days for all hospitalized patients that were admitted to General, Psychiatric Ward as well as Intensive Care Unit (ICU).|Randomization to end of study up to 76 months|All randomized participants who took at least one dose of study drug.||days|||Number
702823|NCT00088465|Secondary|Number of Psychiatric Visits|Psychiatric visits were outpatient visits to a psychiatrist or psychiatric nurse.|Randomization to end of study up to 76 months|All randomized participants who took at least one dose of study drug.||visits|||Number
702824|NCT00088465|Secondary|Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Month 76 Endpoint|A self-reported questionnaire that consists of 36 questions covering 8 health domains (physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. The mental component summary (MCS) and the physical component summary (PCS) have been constructed based on the 8 SF-36 domains.|Baseline, up to 76 months|Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
702825|NCT00088465|Secondary|Change From Baseline in the Heinrichs-Carpenter Quality of Life Scale (QLS) Total Score at Month 76 Endpoint|Heinrich-Carpenter QLS is an interviewer-rated scale which measures the impact of negative symptoms on occupational, social, and psychological functioning in patients with schizophrenia or schizoaffective disorder. Each of 21 items is rated on a scale from 0 (severely impaired functioning) to 6 (normal or adequate functioning), for a total score range of 0-126. Results are presented as change in Total score.|Baseline, up to 76 months|Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
702826|NCT00088465|Secondary|Change From Baseline in Clinical Global Impression-Severity of Illness (CGI-S) Scores at Month 72 Endpoint|Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Baseline, up to 72 months|Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).||units on a scale||Standard Error|Mean
702827|NCT00088465|Secondary|Change From Baseline in PANSS General Psychopathology Subscales at Month 76 Endpoint|PANSS General Psychopathology Subscale is the Remaining 16 PANSS questions or PANSS Question15 through Question 30. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 16 items is defined as the PANSS General Psychopathology Subscales. Possible score ranges from 16 to 112.|Baseline, up to 76 months|Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
702828|NCT00088465|Secondary|Change From Baseline in PANSS Negative Scores at Month 76 Endpoint|PANSS questions 8-14. Assesses negative symptoms associated with schizophrenia. 7 items make up the negative scale (e.g. blunted affect, emotional withdrawal, poor rapport, and passive/apathetic social withdrawal). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total negative subscale scores range from 7 to 49.|Baseline, up to 76 months|Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
702829|NCT00088465|Secondary|Change From Baseline in PANSS Positive Scores at Month 76 Endpoint|PANSS questions 1-7. Assesses positive symptoms associated with schizophrenia. 7 items make up the positive scale (ex. delusions, conceptual disorganization, and hallucinatory behavior). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total positive subscale scores range from 7 to 49.|Baseline, up to 76 months|Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
702830|NCT00088465|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Scores at Month 76 Endpoint|Assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210.|Baseline, up to 76 months|Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
702831|NCT00088465|Primary|Number of Participants With Adverse Events (AE)|The list of serious adverse events (SAE) and other non-serious adverse events (AE) are in Adverse Events Section.|Randomization to end of study up to 76 months|All randomized participants who took at least one dose of study drug.||participants|||Number
702832|NCT00088530|Secondary|Overall Response Rate (ORR) Lasting at Least 4 Months|The proportion of patients with Complete response or Partial Response with a difference from the first documented objective response to disease progression or death of at least 4 months.|approximately 24 months|Intent-To-Treat (ITT) population||participants|||Number
702833|NCT00088530|Secondary|Overall Survival|The time between the date of randomization and the date of death due to any cause.|18 months after 6 cycles of treatment; approximately 24 months|Intent-To-Treat (ITT) Population.||Months||95% Confidence Interval|Median
702835|NCT00088530|Primary|Complete Response (CR) and Complete Response Unconfirmed (CRu)|Proportion of patients with a best response of complete response (CR) or Complete Response unconfirmed (CRu) in the End Of Treatment (EOT) or End Of Study (EOS) analyses by independent assessment in the Intent-to-treat (ITT) population through the End of Treatment (EOT)|EOT; approximately 6 months|Intent to Treat (all randomized patients)||percentage of randomized patients||95% Confidence Interval|Number
702836|NCT00088595|Secondary|The Overall Safety and Tolerability of Pasireotide|Safety assessments consisted of recording all AEs and serious adverse events (SAEs), the regular monitoring of hematology, blood chemistry, vital signs, physical condition and body weight.|At least 15 days|The safety population consisted of all patients who received study drug (i.e. who started the pasireotide injections) and was thus identical to the Intent to treat (ITT) population.||Participants|||Number
702837|NCT00088595|Secondary|The Number of Patients (Participants) With Overall Tumor Response|The disappearance of all lesions was considered a complete response and at least a 30% decrease in the diameter of lesions was considered a partial response (PR). Progressive disease (PD) required a 20% increase in the sum of the diameters of lesions and changes that did not qualify for PR or PD were considered stable disease. Progression not documented was defined as unknown. No more than a 10% increase in biochemical values, and no clinical signs of DP with complete or adequate control over symptoms were defined as complete treatment success and partial treatment success, respectively.|At least 15 days|The efficacy analysis population (EAP) consisted of 44 patients all of whom had at least one efficacy assessment available after receiving at least one dose of study drug, but excluded 1 patient who had no post-baseline efficacy assessments.||Participants|||Number
702838|NCT00088595|Secondary|Duration of Partial Symptom Control (Days) by Dose Class|Partial symptom control: an average of less than four bowel movements per day for at least 15 consecutive days, with no more than six episodes per any given day, and an average of less than two daily flushing episodes over the same given time interval.|up to 15 days|The efficacy analysis population (EAP) consisted of 44 patients all of whom had at least one efficacy assessment available after receiving at least one dose of study drug, but excluded 1 patient who had no post-baseline efficacy assessments. n= then number of patients with partial sympton control||Days||Standard Deviation|Mean
702839|NCT00088595|Secondary|Duration of Complete Symptom Control (Days) by Dose Class|Complete symptom control: an average of three or less bowel movements per day for at least 15 consecutive days, with no more than three episodes on any given day, and no episodes of flushing over the time interval being studied.|15 days|The efficacy analysis population (EAP) consisted of 44 patients all of whom had at least one efficacy assessment available after receiving at least one dose of study drug, but excluded 1 patient who had no post-baseline efficacy assessments. n= the number of patients with complete symptom control.||Days||Standard Deviation|Mean
702840|NCT00088595|Primary|Symptom Control (Diarrhea/Flushing) Using a Patient Symptom Diary|"Complete Symptom Control: an average of ≤ 3 bowel movements per day for at least 15 consecutive days, with no more than 3 episodes on any given day, and no episodes of flushing over the time interval being studied.
Partial Symptom Control: an average of < 4 bowel movements per day for at least 15 consecutive days, with no more than 6 episodes per given day, and an average of fewer than 2 daily flushing episodes over the same given time interval.
Treatment failure: Failure to obtain partial or complete treatment success over a consecutive 15-day period at a constant dose level."|15 days|The efficacy analysis population (EAP) consisted of 44 patients all of whom had at least one efficacy assessment available after receiving at least one dose of study drug, but excluded 1 patient who had no post-baseline efficacy assessments.||participants|||Number
702841|NCT00088621|Primary|Number of Subjects With an Adverse Events in a One Year Open Label Lurasidone Study||1 year|Number of subjects that entered into the extension trial.||participants|||Number
702842|NCT00088634|Secondary|Change From Baseline to the End of the Double-blind Treatment in the MADRS (Montgomery Asberg-Depression Scale) Scores|The MADRS is a 10-item rating scale that assesses apparent and reported sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item is scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity.|Baseline and 6 weeks|Efficacy analyses will be based on the ITT (intent-to-treat)population. The ITT population will consist of all patients who are randomized, taken one dose of study medication and had at least 1 post-baseline efficacy assessment of the PANSS.||units on scale||95% Confidence Interval|Least Squares Mean
702843|NCT00088634|Secondary|Change From Baseline to the End of the Double-blind Treatment in the CGI-S (Clinical Global Impression of Severity) Scores|The CGI Severity (CGI-S) assesses the severity of illness of the patient relative to the particular population on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Baseline and 6 weeks|Efficacy analyses will be based on the ITT (intent-to-treat)population. The ITT population will consist of all patients who are randomized, taken one dose of study medication and had at least 1 post-baseline efficacy assessment of the PANSS.||units on a scale||95% Confidence Interval|Least Squares Mean
702844|NCT00088634|Secondary|Change From Baseline to the End of the Double-blind Treatment in the PANSS (Positive and Negative Syndrome Scale) Scores|The PANSS is a 30-item scale that evaluates positive, negative, and other symptoms in patients with schizophrenia. Each item is rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme). Scores range from 30-210 with higher scores representing a worsening of schizophrenia.|Baseline and 6 weeks|Efficacy analyses will be based on the ITT (intent-to-treat)population. The ITT population will consist of all patients who are randomized, taken one dose of study medication and had at least 1 post-baseline efficacy assessment of the PANSS||units on a scale||95% Confidence Interval|Least Squares Mean
702845|NCT00088634|Primary|Change From Baseline to the End of the Double-blind Treatment in the BPRS (Brief Psychiatric Rating Scale) Total Score|The BPRS consists of 18 ordered categorical items (from “not present” to “extremely severe,” on a 1- to 7-point scale), each developed to assess patient symptomatology in a relatively discrete symptom area. The BPRS will be extracted from the PANSS by adding the scores of the 18 items (P2 to P7, N1, N2, and G1 to G10) of the PANSS and will not be assessed separately.|Baseline and 6 weeks|Efficacy analyses will be based on the ITT (intent-to-treat)population. The ITT population will consist of all patients who are randomized, taken one dose of study medication and had at least 1 post-baseline efficacy assessment of the PANSS.||units on a scale||95% Confidence Interval|Least Squares Mean
729269|NCT00388973|Secondary|Tolerability as Measured by Adverse Event Withdrawals During Treatment||Baseline to Week 9|All Randomized patients.||Participants|||Number
702846|NCT00088881|Secondary|3-year Overall Survival (OS) Rate|Overall survival (OS) is defined as the time from step 1 registration to death of any cause. OS is censored at the date last known alive for cases that are alive. The 3-year OS rate is defined as the probability of patients remaining alive at 3 years.|Assessed every 3 months for 2 years, then every 6 months for 3 years; then annually to 10 years from patient entry.|Eligible and treated patients||probability||95% Confidence Interval|Number
702847|NCT00088881|Secondary|3-year Time to Treatment Failure (TTF) Rate|Time to treatment failure (TTF) is defined as the time from step 1 registration to disease progression or death. TTF is censored at last documented progression free for cases without progression. The 3-year TTF rate is defined as the probability of patients remaining free from treatment failure at 3 years.|Assessed every 3 months for one year; every 4 months for the second year; then every 6 months for 3 years; then annually to 10 years from patient entry.|Eligible and treated patients||probability||95% Confidence Interval|Number
702848|NCT00088881|Primary|Functional CR in Patients Treated With R-CHOP Followed by 90-Yttrium -Zevalin™.|Patients will be considered a functional CR if they meet the criteria for a CR, or if they meet the criteria for a CRu or partial response (PR) by CT and are PET negative. Please see primary outcome #1 for the definition of CR and CRu. PR is defined as: A decrease of >50% in the SPD (sum of products of the diameters) of the six largest (or less) dominant nodes or extra-nodal masses. No increase in the size of the liver or the spleen. No unequivocal progression in any non-measurable or non-dominant site. Splenic and hepatic nodules must regress by >50% in SPD (sum of the products of the diameters). Bone marrow assessment is not relevant for determination of a PR because it is assessable and not measurable disease. No new sites of disease.|Assessed after 2 cycles of R-CHOP, after completion of R-CHOP, and at Week 12 After 90-Yttrium Zevalin|Eligible and treated patients.||proportion of participants||95% Confidence Interval|Number
702849|NCT00088881|Primary|Complete Response (CR) +Complete Response/Uncertain (CRu) in Patients Treated With R-CHOP Followed by 90-Yttrium -Zevalin™.|Response was assessed based upon the criteria from the International Workshop to Standardize Criteria for Non-Hodgkin’s Lymphoma (Cheson, 1999). CR is defined as complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease related B-symptoms if present prior to therapy, as well as normalization (normal limits of institutional labs) of those biochemical abnormalities (e.g., LDH) definitely attributed to NHL. CRu is defined as meeting the criteria of CR except one or more of the followings: A residual dominant node (or extra-nodal mass) that is currently > 1.5 cm in greatest diameter that has decreased by > 75% from baseline in the product of its diameters. Individual dominant nodes (or extra-nodal masses) that were previously confluent must have decreased by > 75% in SPD compared with the size of the original mass. Indeterminate bone marrow (increased number or size of aggregates without cytologic or architectural atypia).|Assessed after 2 cycles of R-CHOP, after completion of R-CHOP, and at Week 12 After 90-Yttrium Zevalin|Eligible and treated patients||proportion of participants||95% Confidence Interval|Number
702850|NCT00088907|Secondary|Overall Response Rate|"Tumor response was assessed via Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. Complete response (CR) was defined disappearance of all tumor lesions. Partial response (PR) was defined as as at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter. Overall response rate= CR+PR.
Tumor measurements may be made using physical examination, CT scans or MRI scans. While on protocol treatment, tumor measurement by physical examination to be done every 4 weeks, and tumor measurement by CT/MRI scans to be done every 8 weeks (every 2 treatment cycles).
All eligible and treated patients were included in the analysis."|assessed every 3 months if patient is < 2 years from study entry then every 6 months if patient is 2-5 years from study entry. No specific requirements if patient is more than 5 years from study entry.|eligible and treated patients||percentage of participants||95% Confidence Interval|Number
702851|NCT00088907|Secondary|Time to Progression|"Time to progression is defined as time from registration to disease progression. Disease progression was assessed via Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, and/or the appearance of one or more new lesion(s), and/or unequivocal progression of existing nontarget lesions .
Tumor measurements may be made using physical examination, CT scans or MRI scans. While on protocol treatment, tumor measurement by physical examination to be done every 4 weeks, and tumor measurement by CT/MRI scans to be done every 8 weeks (every 2 treatment cycles).
All eligible and treated patients were included in the analysis."|assessed every 3 months if patient is < 2 years from study entry then every 6 months if patient is 2-5 years from study entry. No specific requirements if patient is more than 5 years from study entry.|eligible and treated patients||months||95% Confidence Interval|Median
702852|NCT00088907|Primary|Overall Survival|Overall survival is defined as time from registration to death from any cause. All eligible and treated patients were included in the analysis.|assessed every 3 months if patient is < 2 years from study entry then every 6 months if patient is 2-5 years from study entry. No specific requirements if patient is more than 5 years from study entry.|eligible and treated patients||months||95% Confidence Interval|Median
702853|NCT00088972|Secondary|Ki-67 Expression|The difference between the two arms in the percent of patients with non-zero ki-67 expression over the two time periods (baseline and 1-year).|1 year||||||
702854|NCT00088972|Primary|Mammographic Density|The primary outcome measure is change in mammographic density. The null hypothesis is that there is no difference between the arms in change in mammographic density over one year versus the alternative that the treatment arm reduces mammographic density by 10 points (percent of pixels highlighted) or more over one year compared to the change in the placebo arm.|1 year|Counts represent number of patients for by arm for whom a 1 year mammographic density image was submitted. However, since the study was closed early due to poor accrual, there was insufficient accrual to evaluate study endpoints, and these images were never analyzed.|||||
702855|NCT00088985|Secondary|Immune Response|Measured by intracellular cytokine staining for Interferon-gamma (INFgamma) and cluster of differentiation (CD107) up regulation and tetramer. A fourfold increase in the number of cluster of differentiation (CD8+) tetramers comparing prevaccine with peak postvaccine values indicated an immune response to the therapy.|3 months following treatment|||Participants|||Count of Participants
707357|NCT00122369|Primary|Pain Ratings at Specified Time Point During the Procedure|Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain|30 min|Patients remaining on procedure table||units on a scale||Inter-Quartile Range|Median
702856|NCT00088985|Primary|Overall Response Rate|"Response measured by Response Evaluation Criteria In Solid Tumors (RECIST), (Complete Response + Partial Response)
Complete Response (CR)− Disappearance of all target lesions
Partial Response (PR)−at least a 30% decrease in the longest diameters of target lesions, taking as reference the baseline longest diameter."|6 months following treatment|||Participants|||Count of Participants
702857|NCT00089011|Secondary|Rate and Duration of Steroid Use for the Treatment of Chronic GVHD||15 Years|Only those patients who received steroids for treatment of chronic GVHD.||days||Full Range|Median
702858|NCT00089011|Secondary|Rates of Relapse-related Mortality||Up to 5 years|||Participants|||Count of Participants
702859|NCT00089011|Secondary|Rates of Disease Progression||Up to 5 years|||Participants|||Count of Participants
702860|NCT00089011|Secondary|Incidences of Grades II-IV Acute GVHD||Day 180 post-transplantation|||Participants|||Count of Participants
702861|NCT00089011|Secondary|Overall Survival||At 1 year after conditioning|||Participants|||Count of Participants
702862|NCT00089011|Secondary|Incidences of Graft Rejection||Day 180 post-transplantation|||Participants|||Count of Participants
702863|NCT00089011|Primary|Incidence of Chronic Extensive GVHD||Day 180 post-transplantation|||Participants|||Count of Participants
702864|NCT00089011|Primary|Incidence of Grade III/IV GVHD||Day 180 post-transplantation|||Participants|||Count of Participants
702865|NCT00089076|Secondary|Mean Change in % of CD3+CD4- for the Marker CD45RO+|Flow cytometric analysis of T-cell surface markers before and 1 month after initiation therapy|Before treatment to 1 month after therapy initiation|The analysis population contains patients that had peripheral blood available for analysis from before and 1 month after initiating therapy along with being able to conduct the analysis on the marker. This resulted in the number of participants analyzed being less than the enrolled participants.||percentage of change of CD3+CD4-||Standard Error|Mean
702866|NCT00089076|Secondary|Mean Change in % of CD3+CD4+ for Marker CD45RO+|Flow cytometric analysis of T-cell surface markers before and 1 month after initiation therapy|Before treatment to 1 month after therapy initiation|The analysis population contains patients that had peripheral blood available for analysis from before and 1 month after initiating therapy along with being able to conduct the analysis on the marker. This resulted in the number of participants analyzed being less than the enrolled participants.||percentage of change of CD3+CD4+||Standard Error|Mean
702867|NCT00089076|Secondary|Mean Change in % of CD3+CD4- for Marker HLA-DR+|Flow cytometric analysis of T-cell surface markers before and 1 month after initiation therapy|Before treatment to 1 month after therapy initiation|The analysis population contains patients that had peripheral blood available for analysis from before and 1 month after initiating therapy along with being able to conduct the analysis on the marker. This resulted in the number of participants analyzed being less than the enrolled participants.||percentage of change of CD3+CD4-||Standard Error|Mean
702868|NCT00089076|Secondary|Mean Change in % of CD3+CD4+ for Marker HLA-DR+|Flow cytometric analysis of T-cell surface markers before and 1 month after initiation therapy|Before treatment to 1 month after therapy initiation|The analysis population contains patients that had peripheral blood available for analysis from before and 1 month after initiating therapy along with being able to conduct the analysis on the marker. This resulted in the number of participants analyzed being less than the enrolled participants.||percentage of change of CD3+CD4+||Standard Error|Mean
702869|NCT00089076|Secondary|Duration of Response (Phase 2)|Duration of response will be calculated from the documentation of confirmed response until the date of progression in the subset of patients who respond.|From response to progression (up to 2 years)|No participants proceeded to Phase 2 for evaluation.|||||
702870|NCT00089076|Secondary|Overall Survival (Phase 2)|The overall survival or survival time is defined as the time from registration to death due to any cause. The distribution of overall survival will be estimated using the method of Kaplan-Meier.|From registration to death (up to 2 years)|No participants proceeded to Phase 2 for evaluation.|||||
702871|NCT00089076|Secondary|Time to Progression (Phase 2)|The time to progression is defined as the time from registration to the time of progression. Those who die will be considered to have had disease progression unless documented evidence clearly indicates no progression has occurred. The distribution of time to progression will be estimated using the method of Kaplan-Meier.|From registration to progression (up to 2 years)|No participants proceeded to Phase 2 for evaluation.|||||
702872|NCT00089076|Primary|Number of Overall Confirmed Responses(Complete Response or Partial Response)|Confirmed response is at least a 50% decrease in the sum of the products of the greatest diameters (SPD) of the six largest dominant nodes or nodal masses and no increase in the size of other nodes, liver, or spleen and splenic and hepatic nodules must regress by at least 50% in the SPD and no new sites of disease.|From registration to month 7|||participants|||Number
702873|NCT00089141|Secondary|End of Systemic Treatment|Withdrawal of all immunosuppressive treatment without recurrent malignancy|within 4 years|||participants|||Number
702874|NCT00089141|Secondary|Withdrawal of Prednisone|Withdrawal of treatment with prednisone after improvement or resolution of chronic GVHD|within 4 years|||participants|||Number
702875|NCT00089141|Secondary|Death|Death from any cause after enrollment in the study|within 4 years|||participants|||Number
702876|NCT00089141|Secondary|Death or Recurrent Malignancy|Death due to any cause or development of recurrent malignancy at any time after enrollment|within 4 years|||participants|||Number
702877|NCT00089141|Secondary|Non-relapse Mortality|Death without prior development of recurrent malignancy|within 4 years|||participants|||Number
702878|NCT00089141|Secondary|Recurrent Malignancy|Development of recurrent malignancy after enrollment in the study|within 4 years|||participants|||Number
702879|NCT00089141|Secondary|Bronchiolitis Obliterans|Development of bronchiolitis obliterans during treatment|within 4 years|||participants|||Number
702880|NCT00089141|Secondary|Open Label Systemic Treatment Because of Inadequate Response to Primary Therapy|Administration of any systemic therapy other than the immunosuppressive agents used for initial treatment, because of persistent or progressive chronic graft-versus-host disease|2 years|||participants|||Number
702881|NCT00089141|Secondary|Definitive Absence of Efficacy Success|Administration of secondary systemic therapy for chronic GVHD, death during primary therapy, or onset of recurrent malignancy or bronchiolitis obliterans during primary therapy|2 years|||participants|||Number
702884|NCT00089297|Secondary|Progression-free Survival|Progression-free survival was defined as the time from registration to documented progression or death without progression. Progression is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s) or unequivocal progression of existing nontarget lesions.|Assessed at weeks 7, 14, 18, 20, and then every every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry|Only eligible patients are included in the analysis.||Months||95% Confidence Interval|Median
702885|NCT00089297|Secondary|Proportion of Patients With Objective Response by RECIST|Per RECIST criteria, Complete response (CR)= disappearance of all target and nontarget lesions Partial response (PR)= >=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits. Objective response = CR + PR.|Assessed at weeks 7, 14, 18, 20, and then every every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry|Only eligible patients are included in this analysis.||proportion of patients||95% Confidence Interval|Number
702886|NCT00089297|Primary|Event-free Survival Rate at 1 Year|Event-free survival rate at 1 year was defined as the proportion of patients who did not have disease progression, primary site surgery, or death after being followed for 1 year.|Assessed at 1 year.|Only eligible patients are included in the analysis.||proportion of patients||95% Confidence Interval|Number
702887|NCT00089414|Secondary|Change in Beck Depression Inventory (BDI) Factors Associated With Premenstrual Symptoms|"The Beck Depression Inventory (BDI)is a 21-question multiple-choice self-report inventory, one of the most widely used instruments for measuring the severity of depression. Total scores are interpreted per these ranges:
0–9: indicates minimal depression 10–18: indicates mild depression 19–29: indicates moderate depression 30–63: indicates severe depression."|Every 2 weeks for 3 months|This study was terminated early due to confounding factors in design. Protocol terminated after receiving information from manufacturer (Pharma) that CDB-2914 crosses the blood-brain barrier, invalidating Arm #3 due to potential Central Nervous System effect of the compound on behavior.|||||
702888|NCT00089414|Primary|Change in Premenstrual Tension Syndrome Scale (PMTS) Factors Associated With Premenstrual Symptoms.|The PMTS observer scales assess symptoms in ten different domains including irritability-hostility; tension; efficiency; dysphoria; moodiness; motor coordination; mental-cognitive functioning; eating habits; sexual drive and activity; physical symptoms and social impairment. They have been used to measure premenstrual symptom severity and response to treatment in several clinical trials and prevalence studies. Score ranges from no symptoms to severe symptoms on a scale of 0 to 6, with 0 being no symptoms and 6 being severely symptomatic.|Every 2 weeks for 3 months|This study was terminated early due to confounding factors in design. Protocol terminated after receiving information from manufacturer (Pharma) that CDB-2914 crosses the blood-brain barrier, invalidating Arm #3 due to potential Central Nervous System effect of the compound on behavior.|||||
702889|NCT00089414|Secondary|Change in Clinical Global Impression Scale (CGI) Factors Associated With Premenstrual Symptoms.|The CGI was developed for use in NIMH-sponsored clinical trials to provide a brief, stand-alone assessment of the clinician's view of the patient's global functioning prior to and after initiating a study medication.1 The CGI provides an overall clinician-determined summary measure that takes into account all available information, including a knowledge of the patient's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the patient's ability to function. The CGI actually comprises two companion one-item measures evaluating the following: (a) severity of psychopathology from 1 to 7 and (b) change from the initiation of treatment on a similar seven-point scale, with 1 being normal/more improved and 7 being severe/worse.|Every 2 wks for 3 months|This study was terminated early due to confounding factors in design. Protocol terminated after receiving information from manufacturer (Pharma) that CDB-2914 crosses the blood-brain barrier, invalidating Arm #3 due to potential Central Nervous System effect of the compound on behavior.|||||
702890|NCT00089479|Secondary|Disease Free Survival Including Any New Cancer as Event [Time to Event]|Time from the date of randomization until the date of first event (recurrence of breast cancer, any new cancer, or death due to any cause). Patients without event at the time of the analysis were censored using the date they were last known to be recurrent disease free.|Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.|Intent−to−Treat Population||months||95% Confidence Interval|Median
702891|NCT00089479|Secondary|Disease Free Survival Including Any New Cancer as Event [Number of Events]|Number of patients with/without recurrence of breast cancer, any new cancer, or death due to any cause.|Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.|Intent−to−Treat Population||participants|||Number
702892|NCT00089479|Secondary|Disease Free Survival Including New Primary Breast Cancer as Event [Time to Event|Time from the date of randomization until the date of first event (recurrence of breast cancer, new primary breast cancer, or death due to any cause). Patients without event at the time of the analysis were censored using the date they were last known to be recurrent disease free.|Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.|Intent−to−Treat Population||months||95% Confidence Interval|Median
702893|NCT00089479|Secondary|Disease Free Survival Including New Primary Breast Cancer as Event [Number of Events]|Number of patients with/without recurrence of breast cancer, new primary breast cancer, or death due to any cause.|Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.|Intent−to−Treat Population||participants|||Number
702894|NCT00089479|Secondary|Breast Cancer Free Survival [Time to Event]|Breast cancer-free survival was measured as time from the date of randomization to the date of recurrence of breast cancer, new primary breast cancer, or death related to the chemotherapy administered or due to breast cancer. Patients without event at the time of the analysis were censored using the date they were last known to be recurrent disease free.|Time from the date of randomization to death, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.|Intent−to−Treat Population||months||95% Confidence Interval|Median
702895|NCT00089479|Secondary|Breast Cancer Free Survival [Number of Events]|Number of patients with/without recurrence of breast cancer, new primary breast cancer, or death related to the chemotherapy administered or due to breast cancer.|Time from the date of randomization to event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years .|Intent−to−Treat Population||participants|||Number
702896|NCT00089479|Secondary|Overall Survival [Time to Event]|Overall survival was measured as the time from the date of randomization to the date of death. Patients still alive at the time of the analysis were censored using the date they were last known to be alive.|Time from the date of randomization to the date of death, or date last known to be alive. Patients were followed for an average of 5 years.|Intent−to−Treat Population||months||95% Confidence Interval|Median
702897|NCT00089479|Primary|Disease Free Survival [Time to Event]|Disease free survival was measured as the time from the date of randomization until the date of first event (recurrence of breast cancer, or death due to any cause). Patients without event at the time of the analysis were censored using the date they were last known to be recurrent disease free.|Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.|Intent−to−Treat Population||months||95% Confidence Interval|Median
702898|NCT00089479|Secondary|Overall Survival [Number of Events]|Number of patients who died/were alive.|Time from the date of randomization to the date of death, or date last known to be alive. Patients were followed for an average of 5 years.|Intent−to−Treat Population||participants|||Number
702899|NCT00089479|Primary|Disease Free Survival [Number of Events]|Number of patients with/without recurrence of breast cancer, or death due to any cause.|Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.|Intent−to−Treat Population||participants|||Number
702900|NCT00089505|Secondary|Percent of Participants Who Reported to Never Missed Any of the Study Drug Regimen in the Past Month|Self-reported adherence at week 48 and 96 while participants remained on randomized regimen. Adherence interviews for each antiretroviral drug drug the participant is taking was performed by site personnel every 24 weeks. For NVP/NVP and NVP/LPV_r arms, data through DSMB review cutoff (October 6, 2008) were used to report the outcome. For NoNVP/NVP and NoNVP/LPV_r arms, since the follow-up continued as planned, data through overall study were used.|Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r arms. Throughout study for NoNVP/NVP and NoNVP/LPV_r arms.|Numbers presented use as-treated approach.||percent of participants|||Number
702901|NCT00089505|Secondary|Number of Participants Who Received NVP-containing Regimens at Randomization and Experienced NVP-associated Rash or Grade 2+ Liver Lab Abnormality|Any grade of rash or grade 2+ liver lab abnormality events that were claimed to be NVP associated (definitely, probably, or possibly) by site investigators were evaluated. Grade 2+ liver lab abnormality is defined as aspartate aminotransferase (AST)>=2.6 x ULN or alanine aminotransferase (ALT)>=2.6 x ULN.|Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP arm. Throughout study for NoNVP/NVP arm.|Numbers presented use the as-treated approach.||participants|||Number
702902|NCT00089505|Primary|Time From Randomization to Virologic Failure or Death for Participants Without SD NVP Exposure Prior to Study Entry|5th and 10th Percentiles in weeks from randomization to virologic failure (VF) or death. VF is defined as a plasma HIV-1 RNA level that is 1 log10 below baseline 12 weeks after treatment is initiated or as a plasma HIV-1 RNA level that is >=400 copies/mL at or after 24 weeks of treatment, regardless of whether randomized treatment was being taken at the time of VF.|Throughout study with median follow-up 72 weeks and range from 0 to 180 weeks.|The analysis was intent to treat per protocol.||weeks||95% Confidence Interval|Number
702903|NCT00089505|Primary|Time From Randomization to Virologic Failure or Death for Participants Who Had SD NVP Exposure Prior to Study Entry|5th and 10th Percentiles in weeks from randomization to virologic failure (VF) or death. VF is defined as a plasma HIV-1 RNA level that is 1 log10 below baseline 12 weeks after treatment is initiated or as a plasma HIV-1 RNA level that is >=400 copies/mL at or after 24 weeks of treatment, regardless of whether randomized treatment was being taken at the time of VF.|Through database cutoff for DSMB review (by October 6, 2008) with median follow-up 72 weeks and range from 0 to 144 weeks.|Numbers presented use the intent-to-treat approach (i.e. ignoring changes from randomized treatment).||weeks||95% Confidence Interval|Number
702904|NCT00089505|Secondary|Number of Participants Who Experienced HIV-related Disease Progression or Death|Worsening to WHO stage III/IV (among subjects who had WHO stage I/II at baseline) and death were the composite secondary endpoint. WHO Disease Staging System for HIV Infection and Disease in Adults and Adolescents is an approach for use in resource limited settings in studies of progression to symptomatic HIV disease. There are 4 stages of disease staging, 1 being the least severe and 4 being the most severe disease stage based on the HIV related symptoms and diagnoses. Please refer to the following web page for detailed staging criteria: http://www.who.int/docstore/hiv/scaling/anex1.html|Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r. Throughout study for NoNVP/NVP and NoNVP/LPV_r.|Numbers presented use the intent-to-treat approach (i.e. ignoring changes from randomized treatment).||participants|||Number
702905|NCT00089505|Secondary|Number of Participants Who Experienced Treatment-related Toxicity That Led to Discontinuation of Randomized Regimen.|The outcome is defined as treatment-related toxicity (as evaluated by sites), regardless of grade, that led to discontinuation of randomized regimen. For NVP/NVP and NVP/LPV_r arms, data through DSMB review cutoff (October 6, 2008) were used to report the outcome. For NoNVP/NVP and NoNVP/LPV_r arms, since the follow-up continued as planned, data through overall study were used.|Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r. Throughout study for NoNVP/NVP and NoNVP/LPV_r.|Numbers presented use as-treated method.||participants|||Number
702906|NCT00089505|Secondary|CD4 Count Change From Randomization|Change was calculated as the CD4 count at Week 48 (or at Week 96) minus the baseline CD4 count (last CD4 before/on treatment start date). For NVP/NVP and NVP/LPV_r arms, data through DSMB review cutoff (October 6, 2008) were used to report the outcome. For NoNVP/NVP and NoNVP/LPV_r arms, since the follow-up continued as planned, data through overall study were used.|Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r. Throughout study for NoNVP/NVP and NoNVP/LPV_r. Week 48 and 96.|Changes were calculated using the intent-to-treat approach (i.e. ignoring changes from randomized treatment) but no imputation was done for missing values.||cells/mm^3||Inter-Quartile Range|Median
702907|NCT00089505|Secondary|Percent of Participants Who Experienced Virologic Failure or Died|Results report cumulative percent of participants reaching virologic failure (VF) or death by week 48 and week 96 calculated using the Kaplan-Meier method. VF is defined as a plasma HIV-1 RNA level that is 1 log10 below baseline 12 weeks after treatment is initiated or as a plasma HIV-1 RNA level that is >=400 copies/mL at or after 24 weeks of treatment, regardless of whether randomized treatment was being taken at the time of VF.|Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r arms. Throughout study for NoNVP/NVP and NoNVP/LPV_r arms.|Numbers presented use the intent-to-treat approach (i.e. ignoring changes from randomized treatment).||Percent of participants||95% Confidence Interval|Number
702908|NCT00089505|Secondary|Number of Participants Who Experienced Virologic Failure or Died.|Virologic failure (VF) is defined as a plasma HIV-1 RNA level that is 1 log10 below baseline 12 weeks after treatment is initiated or as a plasma HIV-1 RNA level that is >=400 copies/mL at or after 24 weeks of treatment, regardless of whether randomized treatment was being taken at the time of VF.|Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r. Throughout study for NoNVP/NVP and NoNVP/LPV_r.|Numbers presented use the intent-to-treat approach (i.e. ignoring changes from randomized treatment).||participants|||Number
702909|NCT00089544|Secondary|Response to Pre-operative Therapy Assessed Using RECIST Criteria||From start of treatment to time of surgery.|"This analysis was not carried out due to the small number of patients accrued to the study. See section Limitations and Caveats."|||||
702910|NCT00089544|Secondary|Wound Complication (Grades 2, 3, 4, and 5) as Measured by CTCAE v3.0|Will be estimated using a binomial distribution and accompanied by the associated 95% confidence interval.|From start of treatment to time of surgery|"This analysis was not carried out due to the small number of patients accrued to the study. See section Limitations and Caveats."|||||
702911|NCT00089544|Primary|Treatment Delivery With Compliance Defined as Receiving at Least 95% of the Pre-operative Protocol Dose of RT, All 3 Cycles of MAID (if Applicable), and Receive Thalidomide on 75% of the Days During Radiation|Was to be estimated using a binomial distribution and accompanied by the associated 95% confidence interval. Due to early study closure, this endpoint could not be fully evaluated per the protocol plan.|Duration of treatment (which can continue up to approximately 15 months).|Eligible patients who started study treatment.||participants|||Number
702912|NCT00089583|Secondary|Correlation Between Plasma APV Exposure and Plasma vRNA, CD4+ Cell Counts, and the Occurrence of Adverse Events|No formal analysis has been performed or is planned to correlate plasma APV PK with efficacy and safety outcomes.|Week 48|PK Population|||||
702913|NCT00089583|Secondary|Number of Participants Reporting Perfect Adherence Over the 3 Days Prior to the Study Visits at Weeks 2, 12, 24, and 48 as Assessed by Study Coordinator Using the Pediatric AIDS Clinical Trials Group (PACTG) Adherence Questionnaire|The PACTG Adherence Questionnaire records individual study drugs, the expected number of doses/24 hour period, and the number of doses missed in the 3 days prior to the study visit. Responses were summarized by age cohort, study drug, treatment regimen, and visit for exploratory analysis only.|Weeks 2, 12, 24, and 48|Safety Population. Only those participants contributing data at the indicated time points were analyzed.||participants|||Number
702914|NCT00089583|Secondary|Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent Reductions in Drug Susceptibility (DS)|A blood sample was drawn for par. remaining in the study after Week 48 and failing to respond to therapy, and changes in DS for HIV isolated from the par. for each drug used in the study were assessed. The changes in DS detected by phenotypic assay in virus from the sample collected at the time of failure was compared with DS in the virus from the blood sample at baseline. Par. are grouped by study arm and prior therapy experience. DS is the state of HIV being susceptible to the antiretroviral agent (the virus can be inhibited by the drug). Reduced DS (i.e., HIV is resistant to the antiretroviral agent) can lead to treatment failure.|Week 60 through Week 240|VF: par. with failure to achieve plasma HIV-RNA <400 copies/mL by Week 24; or confirmed HIV-RNA rebound to >=400 copies/mL any time after achieving plasma HIV-RNA <400 copies/mL and had evaluable viral isolate genotypic and/or phenotypic data. Only par. contributing viral phenotype at both baseline and the indicated time of VF points were evaluable||Participants|||Number
702915|NCT00089583|Secondary|Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS)|A blood sample was drawn for par. failing to respond to therapy, and changes in DS for HIV isolated from the par. for each drug used in the study were assessed. The changes in DS detected by phenotypic assay in virus from the sample collected at the time of failure was compared with DS in the virus from the blood sample at baseline. Par. are grouped by study arm and prior therapy experience. DS is the state of HIV being susceptible to the antiretroviral agent (the virus can be inhibited by the drug). Reduced DS (i.e., HIV is resistant to the antiretroviral agent) can lead to treatment failure.|Baseline through 48 Weeks|VF: par. with failure to achieve plasma HIV-RNA <400 copies/mL by Week 24; or confirmed HIV-RNA rebound to >=400 copies/mL any time after achieving plasma HIV-RNA <400 copies/mL and had evaluable viral isolate genotypic and/or phenotypic data. Only par. contributing viral phenotype at both baseline and the indicated time of VF points were evaluable||participants|||Number
702916|NCT00089583|Secondary|Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease|A blood sample was drawn for par. remaining in the study after Week 48 and failing to respond to therapy, and the mutations present in the virus were identified. For each par., the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New International AIDS Society-USA defined resistance mutations that developed at the time of failure were tabulated by drug class. VF, virologic failure; NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor. Par. are grouped by study arm and prior therapy experience.|After Week 48 through Week 240|VF: par. with failure to achieve plasma HIV-RNA <400 copies/mL by Week 24; or confirmed HIV-RNA rebound to >=400 copies/mL any time after achieving plasma HIV-RNA <400 copies/mL and had evaluable viral isolate genotypic and/or phenotypic data. Only par. contributing viral genotype at both baseline and the indicated time of VF points were evaluable.||Participants|||Number
703202|NCT00081263|Primary|Histologic Regression|Whether or not patients with CIN 2/3 or CIN 3 upon entry experience a complete remission (or partial regression to CIN 1) in the post-treatment excisional biopsy.|Post treatment evaluation was done 14 to 18 weeks after treatment randomization|Eligible, Treated, and Evaluable patients||percentage of participants||90% Confidence Interval|Number
702917|NCT00089583|Secondary|Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease|A blood sample was drawn for par. failing to respond to therapy, and the mutations present in the virus were identified. For each par., the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New International AIDS Society-USA defined resistance mutations that developed at the time of failure were tabulated by drug class. VF, virologic failure; NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor. Par. are grouped by study arm and prior therapy experience.|Week 48|VF: par. with failure to achieve plasma HIV-RNA <400 copies/mL by Week 24; or confirmed HIV-RNA rebound to >=400 copies/mL any time after achieving plasma HIV-RNA <400 copies/mL and had evaluable viral isolate genotypic and/or phenotypic data. Only par. contributing viral genotype at both baseline and the indicated time of VF points were evaluable.||participants|||Number
702918|NCT00089583|Secondary|Change From Baseline in the Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Weeks 2, 12, 24, and 48|Blood samples of participants were collected for the measurement of the percentage of total lymphocytes that are CD4+ cells. Observed analysis was used for the summary of proportion endpoints using viral load data. Change from Baseline in percentage was calculated as the value at Weeks 2, 12, 24, and 48 minus the value at Baseline.|Baseline and Week 2, 12, 24, 48|ITT-E Population. Only those participants contributing data at the indicated time points were analyzed. The number of participants analyzed represents the sum of the PI-naïve (received <1 week's treatment with a PI) and -experienced (received >1 week prior PI therapy with no more than 3 PIs before trial enrollment) participants.||Percentage of TLs that are CD4+ cells||Inter-Quartile Range|Median
702919|NCT00089583|Secondary|Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Baseline and Weeks 2, 12, 24, and 48|Blood samples of participants were collected for the measurement of the percentage of total lymphocytes that are CD4+ cells. Observed analysis was used for the summary of proportion endpoints using viral load data.|Baseline and Weeks 2, 12, 24, and 48|ITT-E Population. Only those participants contributing data at the indicated time points were analyzed. The number of participants analyzed represents the sum of the PI-naïve (received <1 week's treatment with a PI) and -experienced (received >1 week prior PI therapy with no more than 3 PIs before trial enrollment) participants.||Percentage of TLs that are CD4+ cells||Inter-Quartile Range|Median
702920|NCT00089583|Secondary|Change From Baseline in CD4+ Cell Count at Weeks 2, 12, 24, and 48|Blood samples of participants were collected for the measurement of CD4+ cell count. Observed analysis was used for the summary of proportion endpoints using viral load data. Change from Baseline was calculated as the value at Weeks 2, 12, 24, and 48 minus the value at Baseline.|Baseline and Weeks 2, 12, 24, and 48|ITT-E Population. Only those participants contributing data at the indicated time points were analyzed. The number of participants analyzed represents the sum of the PI-naïve (received <1 week's treatment with a PI) and -experienced (received >1 week prior PI therapy with no more than 3 PIs before trial enrollment) participants.||cells/cu mm||Inter-Quartile Range|Median
702921|NCT00089583|Secondary|Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 2, 12, 24, and 48|Blood samples of participants were collected for the measurement of CD4+ cell count. Observed analysis was used for the summary of proportion endpoints using viral load data. CD4+ cells are white blood cells that are important in fighting infection. HIV infects CD4+ cells, replicates in them, and destroys them. CD4+ cell count provides a measure of the status of the immune system and to what extent it is affected by HIV.|Baseline and Weeks 2, 12, 24, and 48|ITT-E Population. Only those participants contributing data at the indicated time points were analyzed. The number of participants analyzed represents the sum of the PI-naïve (received <1 week's treatment with a PI) and -experienced (received >1 week prior PI therapy with no more than 3 PIs before trial enrollment) participants.||Cells per cubic millimeter (cells/cu mm)||Inter-Quartile Range|Median
702922|NCT00089583|Secondary|Number of Participants With at Least a 1.0 log10 HIV-1 RNA Decrease From Baseline at Weeks 2, 12, 24, and 48 (Observed Analysis)|Blood samples of participants were collected to assess the decrease in the number of HIV-1 RNA.|Baseline and Weeks 2, 12, 24, and 48|ITT-E Population. In the observed analysis, data are presented for the number of par. still enrolled in the study at a certain time point. The number of par. analyzed represents the sum of the PI-naïve (received <1 week's treatment with a PI) and -experienced (received >1 week prior PI therapy with no more than 3 PIs before trial enrollment) par.||participants|||Number
702923|NCT00089583|Secondary|Median Change From Plasma HIV-1 RNA (log10 Copies/mL) at Weeks 2, 12, 24, and 48 (Observed Analysis)|Blood samples of participants were collected to assess the decrease in the number of HIV-1 RNA. Change from Baseline at Weeks 2, 12, 24, and 48 was calculated as value at Week 2, 12, 24, and 48 minus the value at Baseline.|Baseline and Weeks 2, 12, 24, and 48|ITT-E Population. In the observed analysis, data are presented for the number of par. still enrolled in the study at a certain time point. The number of par. analyzed represents the sum of the PI-naïve (received <1 week's treatment with a PI) and -experienced (received >1 week prior PI therapy with no more than 3 PIs before trial enrollment) par.||log10/copies||Inter-Quartile Range|Median
702924|NCT00089583|Secondary|Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 2, 12, 24, and 48 (Observed Analysis)|Blood samples of participants were collected to assess the decrease in the number of HIV-1 RNA.|Baseline and Weeks 2, 12, 24, and 48|ITT-E Population. In the observed analysis, data are presented for the number of par. still enrolled in the study at a certain time point. The number of par. analyzed represents the sum of the PI-naïve (received <1 week's treatment with a PI) and -experienced (received >1 week prior PI therapy with no more than 3 PIs before trial enrollment) par.||log10 copies/mL||Inter-Quartile Range|Median
702925|NCT00089583|Secondary|Number of Participants (Par.) With Plasma HIV-1 Ribonucleic Acid (RNA) <400 Copies Per Milliliter at Baseline and Weeks 2,12, 24, and 48 (MSD=F)|Blood samples of participants were collected to measure plasma HIV-1 RNA concentrations. PI-exp = PI-experienced. Viral load, measured in RNA copies per milliliter of plasma, is an efficacy measure for antiretroviral drugs. In the Missing, Switch, or Discontinuation = Failure (MSD=F) analysis, participants who had missing data at or had discontinued the study prior to a certain time point or had changed their background antiretroviral regimen are classified as non-responders.|Baseline and Weeks 2, 12, 24, and 48|Intent-to-Treat Exposed (ITT-E) Population. Only those par. contributing data at the indicated time points were analyzed. The number of par. analyzed represents the sum of the PI-naïve (received <1 week's treatment with a PI) and -experienced (received >1week prior PI therapy with no more than 3 PIs before trial enrollment) par.||participants|||Number
702926|NCT00089583|Secondary|Number of Participants (Par.) With Virological Outcome (Plasma HIV-1 Ribonucleic Acid [RNA] <400 Copies/mL) at Week 48|Blood samples of participants were collected to measure plasma HIV-1 RNA concentrations. PI-exp = PI-experienced.Virologic success was defined as plasma HIV-1 RNA <400 copies/mL. Virologic failure: (1) HIV-1 RNA >=400 copies/mL, (2) change of background antiretroviral treatment (ART), (3) discontinued study due to lack of efficacy, (4) discontinued study with last HIV-1 >=400 copies/mL. No virologic data at Week 48 window: (a) discontinued study due to an adverse event or death, (b) discontinued study due to other reasons, (c) missing data during window but still on study.|Week 48|Intent-to-Treat Exposed (ITT-E) Population: par. with documented evidence of receiving >=1 treatment dose. Only par. contributing data were analyzed. The number of par. analyzed is the sum of the PI-naïve (received <1week's treatment with a PI) and -experienced (received >1week prior PI therapy with no more than 3 PIs before trial enrollment) par.||participants|||Number
702927|NCT00089583|Secondary|Plasma FPV t1/2|The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.|Week 48|PK Population|||||
702928|NCT00089583|Secondary|Plasma FPV Tmax|The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.|Week 48|PK Population|||||
702929|NCT00089583|Secondary|Plasma FPV CL/F Following Dosing Expressed in mg|The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.|Week 48|PK Population|||||
702930|NCT00089583|Secondary|Plasma FPV CL/F Following Dosing Expressed in mg/kg|The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.|Week 48|PK Population|||||
702931|NCT00089583|Secondary|Plasma FPV Cmax and Cτ|The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.|Week 48|PK Population|||||
702932|NCT00089583|Secondary|Plasma FPV AUC (0-τ)|The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.|Week 48|PK Population|||||
702933|NCT00089583|Secondary|Plasma RTV t1/2|alf-life (t1/2) is calculated as loge2/λz. The apparent terminal phase rate constant (λz) is the slope of the terminal portion of the logarithmically transformed concentration-time data as estimated by linear regression.|Week 48|PK Population. Participants in the FPV arm did not take RTV; hence, they were not analyzed for this outcome measure. In the FPV/RTV arm, only those participants contributing data at the indicated time points were analyzed.||hours||95% Confidence Interval|Geometric Mean
702934|NCT00089583|Secondary|Plasma RTV Tmax|The time to reach the maximum concentration (Cmax) at steady state is defined as (tmax).|Week 48|PK Population: all participants for whom a plasma PK sample was analyzed. Participants in the FPV arm did not take RTV; hence, they were not analyzed for this outcome measure. In the FPV/RTV arm, only those participants contributing data at the indicated time points were analyzed.||hours||Full Range|Median
702935|NCT00089583|Secondary|Plasma RTV CL/F Following Dosing Expressed in mg|Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated as dose/AUC(0-τ).|Week 48|PK Population. Participants in the FPV arm did not take RTV; hence, they were not analyzed for this outcome measure. In the FPV/RTV arm, only those participants contributing data at the indicated time points were analyzed.||mL/min||95% Confidence Interval|Geometric Mean
702936|NCT00089583|Secondary|Plasma RTV CL/F Following Dosing Expressed in mg/kg|Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated using the formulation: RTV Dose in mg/kg units divided by AUC(0-τ). Normalizing CL/F for bodyweight allows for comparison of CL/F across populations.|Week 48|PK Population. Participants in the FPV arm did not take RTV; hence, they were not analyzed for this outcome measure. In the FPV/RTV arm, only those participants contributing data at the indicated time points were analyzed.||mL/min/kg||95% Confidence Interval|Geometric Mean
702937|NCT00089583|Secondary|Plasma RTV Cτ|The plasma concentration at the end of the dosing interval at steady-state (Cτ) was measured.|Week 48|PK Population. Participants in the FPV arm did not take RTV; hence, they were not analyzed for this outcome measure. In the FPV/RTV arm, only those participants contributing data at the indicated time points were analyzed.||µg/mL||95% Confidence Interval|Geometric Mean
702938|NCT00089583|Secondary|Plasma RTV Cmax|The maximum concentration at steady state (Cmax) was measured.|Week 48|PK Population. Participants in the FPV arm did not take RTV; hence, they were not analyzed for this outcome measure. In the FPV/RTV arm, only those participants contributing data at the indicated time points were analyzed.||µg/mL||95% Confidence Interval|Geometric Mean
702939|NCT00089583|Secondary|Plasma Ritonavir (RTV) AUC (0-τ)|Plasma samples were assayed for RTV concentrations using a validated assay. The GlaxoSmithKline (GSK) Department of Clinical Pharmacology Modeling and Simulation conducted pharmacokinetic (PK) analysis of the plasma RTV concentration-time data using a model-independent approach. As a measure of total drug exposure, the area under the plasma-concentration-versus-time curve over the dosing interval at steady-state (AUC[0-τ]), where τ is the length of the dosing interval, was calculated by the linear up/log down trapezoidal method.|Week 48|PK Population: all participants for whom a plasma PK sample was analyzed. Participants in the FPV arm did not take RTV; hence, they were not analyzed for this outcome measure. In the FPV/RTV arm, only those participants contributing data were analyzed.||hr*µg/mL||95% Confidence Interval|Geometric Mean
702940|NCT00089583|Primary|Number of Participants With Treatment-emergent (TE) Grade 3/4 Clinical Chemistry Laboratory Abnormalities|"A toxicity was considered TE if it was > than the Baseline grade, and if it was observed on/after the date of the first dose of study drug (SD), and on/before the date of the last dose of SD. Leucopenia is the decrease in the number of leucocytes (white blood cells [WBCs]); neutropenia is the decrease in the number of neutrophils (type of WBCs). Per the Division of AIDS Table for Grading the Severity of Adult and Pediatric AEs: Grade 3 is severe; Grade 4 is potentially life-threatening. ULN, upper limit of normal; LDL, low-density lipoprotein; PC, platelet count."|Baseline (Day 1) until Week 48|Safety Population. Only those participants contributing data at the indicated time points were analyzed.||participants|||Number
702941|NCT00089583|Primary|Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) at Week 48|Blood samples of the participants were collected for the evaluation of AST and ALT. Clinical chemistry analyses were carried out using the observed analysis strategy. Change from Baseline in AST and ALT was calculated as the value at Week 48 minus the value at Baseline.|Baseline (Day 1) and Week 48|Safety Population. Only those participants contributing data were analyzed.||International units per liter (IU/L)||Inter-Quartile Range|Median
702942|NCT00089583|Primary|Change From Baseline in Serum Lipase at Week 48|Blood samples of all participants were collected for the evaluation of serum lipase. Clinical chemistry analyses were carried out using the observed analysis strategy. Change from Baseline in serum lipase was calculated as the value at Week 48 minus the value at Baseline.|Baseline (Day 1) and Week 48|Safety Population. Only those participants contributing data were analyzed.||Units per liter (U/L)||Inter-Quartile Range|Median
702943|NCT00089583|Primary|Change From Baseline in Triglycerides, Total Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Serum Glucose at Week 48|Blood samples of all participants were collected under fasting conditions for the evaluation of triglycerides, total cholesterol, HDL cholesterol, LDL cholesterol, and serum glucose. Clinical chemistry analyses were carried out using the observed analysis strategy. Change from Baseline in triglycerides, total cholesterol, HDL cholesterol, LDL cholesterol, and serum glucose was calculated as the value at Week 48 minus the value at Baseline.|Baseline (Day 1) and Week 48|Safety Population. Only those participants contributing data were analyzed.||Millimoles per liter (mmol/L)||Inter-Quartile Range|Median
702944|NCT00089583|Primary|Number of Participants Who Permanently Discontinued the Treatment Due to Any Adverse Event (AE)|An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Week 48|Safety Population: all participants with documented evidence of having received at least one dose of investigational treatment.||participants|||Number
702945|NCT00089583|Primary|Plasma APV t1/2|The apparent terminal phase half-life (t1/2) is calculated as loge2/λz. The apparent terminal phase rate constant (λz) is the slope of the terminal portion of the logarithmically transformed concentration-time data as estimated by linear regression.|Week 48|PK Population. Only those participants contributing data were analyzed.||hours||95% Confidence Interval|Geometric Mean
702946|NCT00089583|Primary|Plasma APV Tmax|The time to reach the maximum concentration (Cmax) at steady state is defined as tmax.|Week 48|PK Population. Only those participants contributing data were analyzed.||hours||Full Range|Median
702947|NCT00089583|Primary|Plasma APV CL/F Following Dosing Expressed in mg|Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated as dose/AUC(0-τ). For FPV, doses were expressed in APV molar equivalents (50 mg of FPV = 43.2 mg of APV).|Week 48|PK Population. Only those participants contributing data were analyzed.||Milliliters per minute (mL/min)||95% Confidence Interval|Geometric Mean
702948|NCT00089583|Primary|Plasma APV CL/F Following Dosing Expressed in mg/kg|Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated using the formulation: APV Dose in mg/kg units divided by AUC(0-τ). For FPV, doses were expressed in APV molar equivalents (50 mg of FPV = 43.2 mg of APV). Normalizing CL/F for bodyweight allows for comparison of CL/F across populations.|Week 48|PK Population. Only those participants contributing data were analyzed.||Milliliters/minute/kilogram (mL/min/kg)||95% Confidence Interval|Geometric Mean
702949|NCT00089583|Primary|Plasma APV Cτ|The plasma concentration at the end of the dosing interval at steady-state (Cτ) was measured.|Week 48|PK Population. Only those participants contributing data were analyzed.||Micrograms per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
702950|NCT00089583|Primary|Plasma APV Cmax|The maximum concentration at steady state (Cmax) was measured.|Week 48|PK Population. Only those participants contributing data were analyzed.||Micrograms per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
702951|NCT00089583|Primary|Plasma Amprenavir (APV) AUC (0-tau[τ])|Plasma samples were assayed for APV concentrations using a validated assay. The GlaxoSmithKline (GSK) Department of Clinical Pharmacology Modeling and Simulation conducted pharmacokinetic (PK) analysis of the plasma APV concentration-time data using a model-independent approach. As a measure of total drug exposure, the area under the plasma-concentration-versus-time curve over the dosing interval at steady-state (AUC[0-τ]), where τ is the length of the dosing interval, was calculated by the linear up/log down trapezoidal method. hr, hour; µg, micrograms; mL, milliliter.|Week 48|Pharmacokinetic (PK) Population: all participants for whom serial plasma PK samples were analyzed. Only those participants contributing data were analyzed.||hr*µg/mL||95% Confidence Interval|Geometric Mean
702952|NCT00089609|Secondary|Changes in the Molecular Markers of Angiogenesis (Including, But Not Limited to Serum and Urine Vascular Endothelial Growth Factor (VEGF)) Before and After Administration of Docetaxel, Prednisone, Thalidomide and Bevacizumab||Baseline and monthly|The outcome was not assessed. In the study, assessment of circulating apoptotic endothelial cells was the main outcome evaluated for assessing the treatment's antiangiogenic activity. Changes in the molecular markers of angiogenesis will not be pursued.|||||
702953|NCT00089609|Secondary|Usefulness of Dynamic Magnetic Resonance Imaging (MRI) to Monitor the Progression of Bony and Soft Tissue Disease in Metastatic Prostate Cancer|Target lesions in the bone or soft tissues will be identified from the participant computed tomography (CT) scan. Dynamic MRI will be performed after the intravenous administration of 0.1 mmol/kg of Gadolinium chelate. Progression is defined by the RECIST criteria and is at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment starts or the appearance of new lesions.|Baseline and at 3 month intervals until progression|The outcome was not assessed as the functionality of dynamic MRI in prostate cancer was poor at the time of this study. Earlier prostate MRI techniques suffered from poor sensitivity and specificity for monitoring progression.|||||
702954|NCT00089609|Secondary|Analyze the Patients Genotype With Regard to Cytochrome P450 2C19 Polymorphism and Correlate That With Pharmacokinetics and Efficacy|Single nucleotide polymorphisms in genes that play an important role in eliminations pathways for docetaxel (in the CYP3A4 and CYP3A5 genes) and thalidomide (CYP2C19) will be evaluated.|Patient entry onto the study|The outcome was not assessed as the clinical significance of cytochrome P450 2C19 polymorphism in angiogenesis is undetermined. This analysis will not be pursued.|||||
702966|NCT00089635|Secondary|Time to Disease Progression|Kaplan-Meier estimate of median time from date of enrollment to date of first observed progression or death date if the death was due to disease progression (whichever comes first); participants who have not progressed while on study or died for reasons other than disease progression while on study were censored at their last evaluable assessment date.|From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.|Adjudicated Prior Failures Analysis Set, composed of all consented and enrolled participants who were determined to be eligible by the Independent Eligibility Review Committee (IERC).||weeks||95% Confidence Interval|Median
702955|NCT00089609|Secondary|Number of Participants With a Significant Increase in Circulating Apoptotic Endothelial Cell (CAEC) Level|"The assay utilized has no standard curve. Categorizing patients with ≥ 75% PSA decline in one group and < PSA decline in another group, every patient is their own control with comparison of CAEC at baseline vs. 6 weeks (after two cycles of treatment). Blood is drawn from the patient and a million viable mononuclear cells are counted and then it is determined how many CAECs are in the specimen. The cell count is then compared from baseline to post 2 cycles of treatment. Thus, significant increase is dependent upon this comparison and varies between patients."|Baseline and at 6 weeks (after two cycles of treatment)|Only 17/60 participants were evaluable for this outcome. Per protocol CAECs were not assessed in the expansion cohort.||participants|||Number
702956|NCT00089609|Secondary|Plasma Concentrations of Docetaxel and Thalidomide and Clinical Activity or Toxicity|The analysis will be performed using a validated method based on liquid chromatography with mass-spectrometric detection.|Pre-dose on C1D1, 5 minutes before the end of infusion, and 15, and 30 minutes, and 1, 2,4,8, and 24 hours after the end of infusion|The outcome was not assessed as the analysis of plasma bevacizumab concentrations was the main pharmacokinetic secondary outcome in the study. The plasma levels of docetaxel and thalidomide (without bevacizumab) had minimal significance in this study. Analysis of plasma concentrations of docetaxel and thalidomide will not be done.|||||
702957|NCT00089609|Secondary|Number of Participants Who Died After a Follow Up of 34 Months Following Treatment|From on study date to date of death at 34 months.|34 months|Per protocol, this outcome was not assessed for the expansion cohort.||participants|||Number
702958|NCT00089609|Secondary|Disease Progression by Clinical and Radiographic Criteria Without the Use of Prostate-Specific Antigen (PSA)|Clinical and radiographic response was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria. Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions. taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking s reference the smallest sum LD since the treatment started. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded or the appearance of one or more new lesions.|up to 34 months|"Only 33/60 participants had measurable disease and were evaluable for this outcome measure.
Per protocol, disease progression by clinical and radiographic criteria without the use of PSA was not assessed for the expansion cohort."||participants|||Number
702959|NCT00089609|Secondary|Time to Progression Using Bubley Criteria|Time to disease progression was based on the Prostate-Specific Antigen (PSA) Working Group 1 Criteria (Bubley Criteria) and standard Response Evaluation Criteria in Solid Tumors (RECIST) for measurable disease. Per the criteria, investigators report at a minimum a PSA decline of at least 50% and this must be confirmed by a second PSA value 4 or more weeks later. Patients may not demonstrate clinical or radiographic evidence of disease progression during this time period.|up to 40 months|Per protocol, time to progression using Bubley Criteria was not assessed for the expansion cohort.||Months||95% Confidence Interval|Median
702960|NCT00089609|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|37 months|||Participants|||Number
702961|NCT00089609|Primary|Immune Response|Cellular immune response and cytokines were evaluated after two cycles of therapy in the expansion cohort. Those cycles included treatment with bevacizumab and docetaxel as a pre-medication.|6 weeks|Cellular immune response and cytokines were not analyzed as the study outcomes were concentrated on the dual-anti-angiogenesis inhibition properties of the regimen and not immunomodulatory changes.|||||
702962|NCT00089609|Primary|Number of Participants Who Had a Prostate-specific Antigen (PSA) Response|PSA response was assessed by the PSA Consensus Criteria. PSA decline is defined as a decline in PSA of at least 50% with no other evidence of disease progression.|21.6 months|The main cohort was designed to evaluate clinical progression and the expansion cohort was designed to evaluate immune response. Thus the expansion cohort is not included here.||Participants|||Number
702963|NCT00089635|Secondary|Overall Survival|Kaplan-Meier estimate of time to death from any cause; participants who had not died while on study or were lost to follow-up were censored at their last contact date.|From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.|Adjudicated Prior Failures Analysis Set, composed of all consented and enrolled participants who were determined to be eligible by the Independent Eligibility Review Committee (IERC).||months||95% Confidence Interval|Median
702964|NCT00089635|Secondary|Duration of Stable Disease|"Kaplan-Meier estimate of median time from date of enrollment to date of first observed progression or death date if the death was due to disease progression (whichever comes first); in those participants who had a best response of stable disease.
Stable Disease is defined as neither sufficient shrinkage of index lesions to qualify for a partial response nor sufficient increase to qualify for progressive disease taking as reference the nadir sum of the products of the longest diameters since the treatment started."|From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.|Subset of Adjudicated Prior Failures Analysis Set, composed of all consented and enrolled participants who were determined to be eligible by the Independent Eligibility Review Committee (IERC), who had a best response of stable disease.||weeks||95% Confidence Interval|Median
702965|NCT00089635|Secondary|Time to Treatment Failure|Kaplan-Meier estimate of median time from date of enrollment to date decision was made to end the treatment phase for any reason; participants who complete the treatment phase or who remain in the treatment phase at the completion of the study were censored at this time.|From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.|Subset of Adjudicated Prior Failures Analysis Set, composed of all consented and enrolled participants who were determined to be eligible by the Independent Eligibility Review Committee (IERC), for whom a decision was made to end treatment for any reason.||weeks||95% Confidence Interval|Median
702997|NCT00089674|Secondary|Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 36|Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 36 Assessed by Dual Energy X-Ray Absorptiometry.|36 months|Randomized subjects who had a nonmissing baseline and >= 1 nonmissing postbaseline data before or at month 36. LOCF used as imputation method.||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
702967|NCT00089635|Secondary|Progression-free Survival Time|Kaplan-Meier estimate of median time from date of enrollment to date of first observed progression or death (whichever comes first); participants who did not progress while on study and did not die while on study were censored at their last evaluable assessment date.|From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.|Adjudicated Prior Failures Analysis Set, composed of all consented and enrolled participants who were determined to be eligible by the Independent Eligibility Review Committee (IERC).||weeks||95% Confidence Interval|Median
702968|NCT00089635|Secondary|Time to Initial Objective Response|Time from date of enrollment to first objective response; participants with stable disease at their last evaluable assessment date were censored at this date and participants with progressive disease while on study were censored after the last response was observed for all participants.|From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.|Subset of Adjudicated Prior Failures Analysis Set, composed of all consented and enrolled participants who were determined to be eligible by the Independent Eligibility Review Committee (IERC), who had an objective tumor response at any time on study.||weeks||Full Range|Median
702969|NCT00089635|Secondary|Objective Tumor Response Throughout the Study|Confirmed objective tumor response was defined as a complete response or partial response from enrollment through to the data cut-ff date. Tumor response was monitored, beginning at Week 8, per a modified version of the World Health Organization (WHO) criteria for tumor response and progression by an independent review committee central assessment. Complete response was defined per modified WHO criteria as disappearance of all lesions (index and non-index). Partial response was defined as ≥ 50% decrease from Baseline in the sum of the products of the longest diameters (SPD) of index lesions. Scans were required to confirm a complete or partial response no earlier than 4 weeks from the time a response of complete or partial response was first documented.|From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.|Adjudicated Prior Failures Analysis Set, composed of all consented and enrolled participants who were determined to be eligible by the Independent Eligibility Review Committee (IERC).||participants|||Number
702970|NCT00089635|Primary|Duration of Response|Kaplan-Meier estimate of time time from first objective response to first observed progression of disease or death if the death was due to disease progression (whichever comes first) among participants who had a response at any time on study. Participants who responded and did not progress while on study or who died for reasons other than disease progression while on study were censored at their last evaluable assessment date.|From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.|Subset of Adjudicated Prior Failures Analysis Set, composed of all consented and enrolled participants who were determined to be eligible by the Independent Eligibility Review Committee (IERC), who had a confirmed objective tumor response at any time on study.||weeks||95% Confidence Interval|Median
702971|NCT00089635|Primary|Objective Tumor Response Through Week 16|Confirmed objective tumor response was defined as a complete response or partial response from enrollment through Week 16. Tumor response was monitored, beginning at Week 8, per a modified version of the World Health Organization (WHO) criteria for tumor response and progression by an independent review committee central assessment. Complete response was defined per modified WHO criteria as disappearance of all lesions (index and non-index). Partial response was defined as ≥ 50% decrease from Baseline in the sum of the products of the longest diameters (SPD) of index lesions. Scans were required to confirm a complete or partial response no earlier than 4 weeks from the time a response of complete or partial response was first documented.|From enrollment through Week 16|Adjudicated Prior Failures Analysis Set, composed of all consented and enrolled participants who were determined to be eligible by the Independent Eligibility Review Committee (IERC).||participants|||Number
702972|NCT00089648|Secondary|Plasma Concentration of Soluble VEGF Receptor-2(sVEGFR-2)|Plasma concentrations of sVEGFR-2 that may be associated with tumor proliferation or angiogenesis collected from a subset of subjects were to have been analyzed by ELISA analysis; however, no data were collected.|1 year|||pg/mL||Full Range|Mean
702973|NCT00089648|Secondary|Plasma Concentration of VEGF-C|Plasma concentrations of VEGF-C that may be associated with tumor proliferation or angiogenesis collected from a subset of subjects were analyzed by ELISA analysis. Samples below the limit of quantitation and samples with insufficient volume available were excluded.|Cycle 1 (Days 1, 14, and 28)|ITT||pg/mL||Full Range|Mean
702974|NCT00089648|Secondary|Plasma Concentration of Placental Growth Factor (PlGF)|Plasma concentrations of PlGF that may be associated with tumor proliferation or angiogenesis collected from a subset of subjects were analyzed by ELISA analysis. Samples below the limit of quantitation and samples with insufficient volume available were excluded.|Cycle 1 (Days 1, 14, and 28)|ITT||pg/mL||Full Range|Mean
702975|NCT00089648|Secondary|Plasma Concentration of Soluble VEGF Receptor-3 (sVEGFR-3)|Plasma concentrations of sVEGFR-3 that may be associated with tumor proliferation or angiogenesis collected from a subset of subjects were analyzed by ELISA analysis. Samples below the limit of quantitation and samples with insufficient volume available were excluded.|Cycle 1 (Days 1, 14, and 28), Cycle 2 (Day 1)|ITT||pg/mL||Full Range|Mean
702976|NCT00089648|Secondary|Plasma Concentration of Vascular Endothelial Growth Factor-A (VEGF-A)|Plasma concentrations of VEGF-A that may be associated with tumor proliferation or angiogenesis collected from a subset of subjects were analyzed by ELISA analysis. Samples below the limit of quantitation and samples with insufficient volume available were excluded.|Cycle 1 (Days 1, 14, and 28), Cycle 2 (Day 1)|ITT||pg/mL||Full Range|Mean
702977|NCT00089648|Secondary|Trough Plasma Concentrations (Cmin) of Total Drug (Sunitinib + SU012662)||Day 28 of Cycle 1 to Cycle 4|ITT||ng/mL||Full Range|Median
702978|NCT00089648|Secondary|Trough Plasma Concentrations (Cmin) of SU012662||Day 28 of Cycle 1 to Cycle 4|ITT||ng/mL||Full Range|Median
702979|NCT00089648|Secondary|Trough Plasma Concentrations (Cmin) of Sunitinib||Day 28 of Cycle 1 to Cycle 4|ITT||ng/mL||Full Range|Median
702980|NCT00089648|Secondary|Progression Free Survival (PFS)|PFS was defined as the time from start of study medication to first documentation of objective tumor progression or to death due to any cause that occurred on treatment including within 28 days after the last dose of study medication, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. PFS (in weeks) was calculated as (first event date minus first dose date +1)/7. Kaplan-Meier method was used.|4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation including 28 day post study follow up|ITT. 20 subjects were censored.||weeks||Full Range|Median
702981|NCT00089648|Secondary|Overall Survival (OS)|OS was defined as the time from start of study treatment to date of death due to any cause. OS (in weeks) was calculated as [date of death minus first dose date +1]/7. For a subject not expiring, the OS time was censored on the last date of known contact that they were known to be alive. Subjects lacking data beyond the day of the first dose had their OS times censored at 1 day. Kaplan-Meier method was used.|4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation including 28 day post study follow up|ITT||weeks||95% Confidence Interval|Median
702982|NCT00089648|Secondary|Duration of Response (DR)|DR was defined as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression or to death due to to any cause that occurred within 28 days after the last dose of study medication, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. DR was only calculated for the subgroup of subjects with a confirmed objective response. DR was calculated as [the end date for DR minus first CR or PR that was subsequently confirmed +1]/7. Kaplan-Meier method was used.|4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation including 28 day post study follow up|ITT subjects (i.e, all subjects enrolled in the study that received at least 1 dose of study medication) who had a confirmed CR or PR. 14 subjects who had a response were analyzed for DR.||weeks||95% Confidence Interval|Median
702983|NCT00089648|Secondary|Time to Tumor Progression (TTP)|TTP was defined as the time from the date of first dose of study medication to the date of the first documentation of tumor progression. If tumor progression data included more than 1 date, the first date was used. TTP (in weeks) was calculated as (first event date minus first dose date +1)/7. Kaplan-Meier method was used.|4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation including 28 day post study follow up|ITT. 20 subjects were censored.||weeks||95% Confidence Interval|Median
702984|NCT00089648|Primary|Number of Subjects With Overall Confirmed Objective Disease Response According to the Response Evaluation Criteria in Solid Tumors (RECIST)|Objective disease response = subjects with confirmed complete response (CR) or partial response (PR) according to RECIST. A CR was defined as the disappearance of all target lesions. A PR was defined as a ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation including 28 day post study follow up|Intent-to-treat (ITT)=all subjects enrolled in the study that received at least 1 dose of study medication.||participants|||Number
702985|NCT00089661|Secondary|Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 6|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|6 months|||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
702986|NCT00089661|Secondary|Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|12 months|||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
702987|NCT00089661|Secondary|Total Hip Bone Mineral Density Percent Change From Baseline at Month 6|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|6 months|||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
702988|NCT00089661|Secondary|Total Hip Bone Mineral Density Percent Change From Baseline at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|12 months|||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
702989|NCT00089661|Secondary|Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 6|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|6 months|||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
702990|NCT00089661|Primary|Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|12 months|Subjects with non-missing baseline and >= 1 non-missing post-baseline evaluation. Using Last Observation Carried Forward as imputation.||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
702991|NCT00089674|Secondary|Number of Participants With Any Fracture Through Month 24|Any fracture includes osteroporotic fractures at any site excluding skull, facial, mandible, metacarpals, finger phalanges, and toe phalanges.|24 months|Full analysis set||Participants|||Number
702992|NCT00089674|Secondary|Time to First Clinical Fracture Through Month 36|A clinical fracture was defined as any nonvertebral fracture or clinically evident fracture at the cervical vertebrae, thoracic vertebrae, and lumbar vertebrae that was associated with signs and/or symptoms indicative of a fracture. Fractures associated with high trauma severity and pathologic (ie, metastatic) fractures were excluded. Since the median time was not reached, time to first clinical fracture is represented by the Kaplan-Meier estimate of the percentage of participants with a clinical fracture.|36 months|Full analysis set||Percentage of participants|||Number
702993|NCT00089674|Secondary|Number of Participants With a New Vertebral Fracture Through Month 36|New Vertebral Fracture Assessed by Lateral Spine X-ray using Genant Semiquantitative Scoring Method excluding any symptomatic new vertebral fracture associated with high trauma severity or a pathologic fracture.|36 months|All randomized subjects who have a baseline and >= 1 postbaseline evaluation of vertebral fracture at or before 3 years.||Participants|||Number
702994|NCT00089674|Secondary|Number of Participants With Any Fracture Through Month 36|Any fracture includes osteroporotic fractures at any site excluding skull, facial, mandible, metacarpals, finger phalanges, and toe phalanges.|36 months|Full analysis set||Participants|||Number
702995|NCT00089674|Secondary|Total Hip Bone Mineral Density Percent Change From Baseline at Month 36|Total Hip Bone Mineral Density Percent Change From Baseline at Month 36 Assessed by Dual Energy X-Ray Absorptiometry.|36 months|Randomized subjects who had a nonmissing baseline and >= 1 nonmissing postbaseline data before or at month 36. LOCF used as imputation method.||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
702996|NCT00089674|Secondary|Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 36|Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 36 Assessed by Dual Energy X-Ray Absorptiometry.|36 months|Randomized subjects who had a nonmissing baseline and >= 1 nonmissing postbaseline data before or at month 36. LOCF used as imputation method.||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
703203|NCT00081289|Secondary|Quality of Life as Assessed After Completion of Chemoradiotherapy and Adjuvant Chemotherapy and Then at 2 Years||From randomization to 3 timepoints: 1) completion of chemoradiation, 2) completion of post-operative chemotherapy (approximately 1 year), and 3) two years||||||
702998|NCT00089674|Secondary|Total Hip Bone Mineral Density Percent Change From Baseline at Month 24|Total Hip Bone Mineral Density Percent Change From Baseline at Month 24 Assessed by Dual Energy X-Ray Absorptiometry.|24 months|Randomized subjects who had a nonmissing baseline and >= 1 nonmissing postbaseline data before or at month 24. LOCF used as imputation method.||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
702999|NCT00089674|Secondary|Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 24|Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 24 Assessed by Dual Energy X-Ray Absorptiometry.|24 months|Randomized subjects who had a nonmissing baseline and >= 1 nonmissing postbaseline data before or at month 24. LOCF used as imputation method.||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
703000|NCT00089674|Primary|Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24|Lumbar Spine Bone Mineral Density Percent Chnage From Baseline at Month 24 Assessed by Dual Energy X-Ray Absorptiometry.|24 months|Randomized subjects who had a nonmissing baseline and >= 1 nonmissing postbaseline data before or at month 24. LOCF used as imputation method.||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
703001|NCT00089752|Secondary|Change in the Score From Baseline to 8 Weeks Treatment SF-36 Mental Component|Change in the score from baseline to 8 weeks treatment, controlling for baseline, in the SF-36 is a 36-item questionnaire that assesses eight health concepts: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Higher scores indicate greater disability with a range of scores from 0-100.|Baseline and after 8 weeks of treatment in ITT sample|The Intent-to-Treat Sample includes all randomized patients exposed to CPAP or Sham treatment during the post randomization treatment period.||scores on a scale||Standard Deviation|Mean
703002|NCT00089752|Secondary|Change in the Score From Baseline to 8 Weeks Treatment on the SF36 - Physical|Change in the score from baseline to 8 weeks treatment, controlling for baseline, in the SF-36 is a 36-item questionnaire that assesses eight health concepts: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Higher scores indicate greater disability with a range of scores from 0-100.|Baseline and Week 8 of treatment in ITT sample.|The Intent-to-Treat Sample includes all randomized patients exposed to CPAP or Sham treatment during the post randomization treatment period.||scores on a scale||Standard Deviation|Mean
703003|NCT00089752|Secondary|Change in the Number of Lapses From Baseline to 8 Weeks Treatment on the Psychomotor Vigilance Task (PVT) - Total Lapses in 20 Minute Test|Change in the score from baseline to 8 weeks treatment, controlling for baseline, in the PVT is an objective assessment of sleepiness and measures decrements in neurobehavioral performance due to sleepiness, i.e., ability to sustain attention and respond in a timely manner to salient signals.(7) The PVT yields five highly informative metrics on the capacity for sustained attention and vigilance performance: frequency of lapses, duration of lapse domain, optimum response time, vigilance decrement function, false response frequency. We applied this conceptually valid, relatively short duration, reliable task with known psychometric properties and minimal practice/learning curves to document attentional lapses (response times > 500 msec) in performance.|Baseline and 8 weeks of treatment in the ITT sample|The Intent-to-Treat Sample includes all randomized patients receiving at least a 20 minute interval of Active during the post randomization treatment period and who had no clinically significant major violations of inclusion or exclusion criteria.||number on a scale||Standard Deviation|Mean
703004|NCT00089752|Secondary|Change in the Score From Baseline to 8 Weeks Treatment Measured by the Profile of Mood States|Change in the score from baseline to 8 weeks treatment, controlling for baseline, in the POMS is a reliable and valid measure of mood states that consists of 65 adjectives on which subjects’ rate themselves as they feel “today” using a five-point scale. There are six mood or affective states on this test derived through factor analysis: Tension-Anxiety (score range 0-36), Depression-Dejection (score range 0 - 60), Anger-Hostility (score range 0-48), Vigor-Activity (score range 0-32), Fatigue-Inertia (score range 0-28), and Confusion-Bewilderment (score range 0-28). There is also a summary Total Mood Disturbance (TMD) score that gives a Total estimate of affective state score range 0-200). Higher scores indicate greater disability.|Measured at Baseline and Week 8 treatment in the ITT sample|Population who had data post-randomization following 8 wks. intervention - ITT analysis||scores on a scale||Standard Deviation|Mean
703005|NCT00089752|Secondary|Change in Mean Arterial Daytime Pressure at Baseline and Week 8 Treatment|Change in mean arterial pressure (MAP) value from baseline to 8 weeks treatment, controlling for baseline, measured by 48 hours ambulatory blood pressure device - Space Laboratories|Measured at Baseline and Week 8 treatment in the ITT sample|Population who had data post-randomization following 8 wks. intervention - ITT analysis||mmHg||Standard Deviation|Mean
703006|NCT00089752|Secondary|Change in the Score From Baseline to 8 Weeks Treatment Epworth Sleepiness Scale|Change in the score from baseline to 8 weeks treatment, controlling for baseline in the self-rated 8 item measure of daytime sleepiness with a range from 0 - 24. Lower values indicting less daytime sleepiness|Measured at Baseline and Week 8 of treatment in ITT sample|Participants randomized and who had post-treatment data in ITT analysis||scores on a scale||Standard Deviation|Mean
703007|NCT00089752|Primary|Change in the Score of the Functional Outcomes of Sleep Questionnaire at Baseline and Week 8 Treatment|The primary endpoint is change after 8 weeks of treatment from baseline value (controlling for baseline value) in the 30-item Functional Outcomes of Sleep Questionnaire (FOSQ) that will be used to test the primary study hypothesis that patients with milder OSA (RDI 5–30) on active treatment will demonstrate greater mean change for the Total score from baseline to 8 weeks treatment. The FOSQ is designed to assess the impact of excessive sleepiness on functional status. The instrument has established content validity, test-retest reliability (r= 0.91), and internal consistency (alpha = 0.96). The scale ranges from 5 - 20 with normal functional status being a value greater than 17.|8 weeks|Consented and randomized participants who completed the FOSQ with mild or moderate obstructive sleep apnea.||scores on a scale||Standard Deviation|Mean
703031|NCT00090051|Secondary|Final Analysis: Duration of Response|Duration of response was defined as the time between the date of the earliest qualifying response and the date of disease progression or death due to any cause.|Median observation time was approximately 5 years|Participants from the Intent-to-treat population, all randomized participants, with complete or partial response.||Days||95% Confidence Interval|Median
703008|NCT00089778|Primary|Immunologic Response to Peptide Vaccination Pre and Post Vaccination|FGF-5 specific CTL (cytotoxic T lymphocytes) may be tested by cytokine release assay or ELISPOT (enzyme linked immunosorbent spot) assay using tumor, FGF-5 transfected or peptide-loaded target cells and compared to pre-treatment peripheral blood mononuclear cells (PBMC) to determine immune response to vaccination. In the assays, differences of 2-3 fold are indicative of true biologic difference.Due to text data entry field limitations, Pre vaccination and post vaccination will be shown in the results as Pre V and Post V, respectively. Patients entered in Group A did not complete sufficient vaccinations to permit immunological evaluation and in Group B, the co-administration of IL-2 is known to corrupt immunological evaluation (so only clinical responses are valid). Expanding information on cancer vaccines in general as wells as preliminary information from this trial on FGF-5 as a vaccine target both served to render the enrollment of additional patients to this trial obsolete.|24 hours|“1 uM A3 culture vs tranfectant” means “Immune cells cultured with the concentration of 1 uM of the A3 peptide were tested against [with] target cells into which the FGF-5 target gene was inserted [transfected with] and the release of interferon is measured to detect immune recognition”.Documentation was only available for the 4 patients.||pg/ml/24 hrs|||Number
703009|NCT00089778|Primary|Count of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events, see the adverse event module.|47 months|||Participants|||Count of Participants
703010|NCT00089778|Primary|Response|Overall response is defined as the best response (e.g. complete response...) recorded from the start of treatment until disease progression/recurrence. Complete response is the disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions. Progressive disease is at least a 20% increase in the sum of LD of target lesions since the treatment started or the appearance of new lesion. Stable disease is neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease.|3 years and 9 months|Pts in Group C had no evaluable disease,response evaluation was not an appropriate endpoint. The purpose of putting such patients in the trial was they were more likely to survive long enough to complete the full sequence of intended vaccinations and permit an immunological/laboratory endpoint evaluation (not as likely for Groups A and B).||Participants|||Count of Participants
703011|NCT00089791|Secondary|Number of Participants With a Hip Fracture|Hip fractures are a subset of nonvertebral fractures including femur neck, femur intertrochanter, and femur subtrochanter.|36 months|Full analysis set||Participants|||Number
703012|NCT00089791|Secondary|Number of Participants With Nonvertebral Fractures|Nonvertebral fractures (osteoporotic) were those occurring on study excluding those of the vertebrae (cervical, thoracic, and lumbar), skull, facial, mandible, metacarpus, finger phalanges, and toe phalanges. Fractures associated with high trauma severity (fractures that were the result of a fall from higher than the height of a stool, chair, first rung on a ladder or equivalent (> 20 inches) or was the result of severe trauma other than a fall) and pathologic fractures were excluded from this category. Nonvertebral fractures were required to be confirmed either by radiographs or other diagnostic images such as computerized tomography (CT) or magnetic resonance imaging (MRI), or by documentation in a radiology report, surgical report, or discharge summary.|36 months|Full analysis set (all randomized participants)||Participants|||Number
703013|NCT00089791|Primary|Number of Participants With New Vertebral Fractures|A new vertebral fracture, assessed by lateral spine X-ray using Genant semiquantitative scoring method, was identified as an ≥ 1 grade increase from the Baseline grade of 0 in any vertebra from T4 to L4. New vertebral fractures included morphometric vertebral fractures (assessed at scheduled visits and not associated with signs or symptoms [or both] indicative of a fracture) and clinical vertebral fractures (assessed at either a scheduled or unscheduled visit and associated with any signs and/or symptoms indicative of a fracture, excluding any fracture associated with high trauma severity or a pathologic fracture).|36 months|Primary Efficacy Analysis Set, which includes all randomized participants who have a baseline and ≥ 1 postbaseline evaluation of vertebral fracture at or before 3 years. Last Observation Carried Forward was used.||Participants|||Number
703014|NCT00089843|Secondary|Markers of Bone Metabolism|type 1 collagen C-telopeptide(CTX); The differences in log-transformed values are reported as percent change.|Baseline to 12 months|1 subject was excluded from analysis. A factorial analysis was performed and determines the effect of each intervention separately, whether or not a subject received the 2nd intervention. Therefore, data from all 76 subjects who participated were used to determine the effect of each intervention on our endpoints.||percent change of CTX||95% Confidence Interval|Mean
703015|NCT00089843|Primary|Bone Mineral Density|Percent change in postero-anterior (PA) spine bone mineral density as measured by dual energy x-ray absorptiometry (DXA)over a 12-month period. The differences in log-transformed values are reported as percent change.|Baseline and 12 months|1 subject was excluded from analysis. A factorial analysis was performed and determines the effect of each intervention separately, whether or not a subject received the 2nd intervention. Therefore, data from all 76 subjects who participated were used to determine the effect of each intervention on our endpoints.||percent change||95% Confidence Interval|Mean
703016|NCT00089895|Secondary|Incidence of the Composite of Death/MI.||30 days after randomization|Intent to treat population||percentage of participants|||Number
703017|NCT00089895|Primary|Incidence of the Composite of Death, Myocardial Infarction (MI), Recurrent Ischemia Requiring Urgent Revascularization (RI-UR), and Thrombotic Bail-out.||96 hours after randomization|Intent to treat population||percentage of participants|||Number
703018|NCT00089986|Secondary|Assessment of Safety/Tolerability by Determining the Number of Participants With Any Adverse Events (AE), Serious Adverse Events (SAE) and Fatal SAE|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition or common toxicity criteria (CTC) grade 4 laboratory abnormalities of national cancer institute not associated with the underlying sepsis unless more severe than expected for the participants condition.|Day 1 (pre-infusion) up to Day 28 Follow-up|ITT Population.||Participants|||Count of Participants
703204|NCT00081289|Secondary|Tumor Marker Evaluation Using Preoperative Tissue Biopsy Specimens and Surgically Resected Tissue Specimens||End of study||||||
703019|NCT00089986|Secondary|Number of Participants With New Onset Organ Failure of Respiratory Failure, Cardiovascular Failure, Renal Failure and Coagulopathy, Regardless of Cause, Occurring During the 28 Days Post Enrollment in an Organ Not in Failure at Enrollment|Respiratory failure: defined by requiring mechanical ventilation not less than 24 hours due to surgery. Renal failure: defined by requiring the initiation of hemodialysis or hemofiltration. Coagulopathy: defined by disseminated intravascular coagulation (DIC) requiring transfusion with platelets or fresh frozen plasma or anticoagulant therapy. Cardiovascular failure: defined by sustained hypotension requiring vasopressor support of dopamine >5 microgram per kilogram per minute (µg/kg/min), epinephrine, norepinephrine, phenylephrine or vasopressin at any dose if used to increase blood pressure for >=6 continuous h. For each organ failure type and the number of new onset organ failures per participants for each organ failure type, the denominator only included participants who did not have that type of organ failure at Baseline. At Baseline a participant could enter the study with a type of organ failure, that type of failure was not reported as a new onset organ failure.|Baseline (Day 1, pre-infusion) up to Day 28 Follow up|ITT Population. Organ failure occurring during the 28 days post-enrollment that was not in failure at enrollment. Participants who died prior to observing a new failure are excluded from analysis.||Participants|||Count of Participants
703020|NCT00089986|Secondary|Number of Participants With New Onset Organ Failure, Regardless of Cause, Occurring During the 28 Days Post Enrollment in an Organ Not in Failure at Enrolment|The new onset organ failure was defined as first time each of the following criteria were met after start of study medication up to Day 28. Respiratory failure: defined by requiring mechanical ventilation not less than 24 hours due to surgery. Renal failure: defined by requiring the initiation of hemodialysis or hemofiltration. Coagulopathy: defined by disseminated intravascular coagulation (DIC) requiring transfusion with platelets or fresh frozen plasma or anticoagulant therapy. Cardiovascular failure: defined by sustained hypotension requiring vasopressor support of dopamine >5 microgram per kilogram per minute (µg/kg/min), epinephrine, norepinephrine, phenylephrine or vasopressin at any dose if used to increase blood pressure for >=6 continuous h. Analysis was done treating the death as a new onset organ failure (counted in both the numerator and denominator).|Baseline (Day 1, pre-infusion) up to Day 28 Follow-up|ITT Population. Organ failure occurring during the 28 days post-enrollment that was not in failure at enrollment. Subjects who die prior to observing a new organ failure are counted as a failure.||Participants|||Count of Participants
703021|NCT00089986|Primary|Percentage of Participants With 28-Day All Cause Mortality|Mortality was assessed by the number of participants who died between days 1 and 28. A summary of death details was given which included whether the participant died between days 1 and 28, whether the death was related sepsis, cause of death, the source of the information, and whether the cause of death was verified by a death record. Participants who had withdrawn from study and all study assessments and for whom survival at day 28 could not be confirmed was treated as deaths for the primary endpoint. The difference in all-cause 28-day mortality rates for each treatment group versus the placebo group in the ITT Population was calculated as placebo – treatment.|Day 1 (post-infusion) up to Day 28 Follow-up|ITT Population was defined as all randomized participants from all three stages who receive any study drug.||Percentage of participants|||Number
703022|NCT00089999|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations. Refer to the general AE/SAE module for a list of non-serious AEs and SAEs.|From the date of the first dose of investigational product until 30 days after the last dose of investigational product (up to study week 192)|Safety Population: all randomized participants who received at least one dose of investigational product.||Participants|||Number
703023|NCT00089999|Secondary|Time to Treatment Failure, as Assessed by IRC and Investigator|Time to treatment failure is calculated as the interval between the date of randomization and the occurrence of local tumor progression (including ipsilateral [on the same side] and controlateral breast tumor progression), distant tumor progression, permanent treatment discontinuation (either for the experimental or conventional treatment arm), or death due any cause. For participants who did not progress, die or discontinue early, time to treatment failure was censored at the last scan date.|From randomization until the first documented sign of disease progression, death due to any cause, or early discontinuation from investigational product (up to Study Week 103)|ITT Population||Weeks||95% Confidence Interval|Median
703024|NCT00089999|Secondary|Progression-free Survival, as Assessed by the IRC and Investigator|Progression-free survival is defined as the time from randomization until the earliest date of disease progression or death due to any cause, if sooner. Disease progression was based on the IRC's and investigator's assessments of the objective evidence (e.g., radiological scans and medical photographs). For participants who did not progress, or die, progression-free survival was censored at the time of the last IRC assessed radiological scan.|From the date of the first dose of investigational product until the earlier of the date of disease progression or death due to any cause (up to Study Week 103)|ITT Population||Weeks||95% Confidence Interval|Median
703032|NCT00090051|Secondary|Final Analysis: Time to Disease-Free Survival Event|Time to disease-free survival (DFS) event was defined as the time from first documented response until the first documented DFS event: disease progression, relapse or death from any cause.|Median observation time was approximately 5 years|Participants from the Intent-to-treat population, all randomized participants, with complete response. .||Days||95% Confidence Interval|Median
703033|NCT00090051|Secondary|Final Analysis: Percentage of Participants With Complete Response|Complete response was defined as the disappearance of all signs of cancer in response to treatment.|Median observation time was approximately 5 years|Intent-to-treat population included all randomized participants.||Percentage of participants|||Number
703074|NCT00090103|Secondary|Number of Events of First BPH Clinical Progression at Years 1, 2, 3 and 4|The time when the first symptom/event of BPH clinical progression has occurred (i.e. AUR, incontinence) was measured. Summaries are based on the first occuring event after treatment start. The time period is from treatment start to each participant's last treatment visit. The Year 4 events include all those that occur during the fourth year and beyond.|Years 1, 2, 3, and 4|ITT Population. As the study progressed, participants dropped out of the study.||events|||Number
703025|NCT00089999|Secondary|Duration of Response (DoR), as Assessed by the IRC and Investigator|DoR is defined for the subset of par. who had a confirmed CR (disappearance of all target lesions (TLs) and non-TLs) or PR (at least a 30% decrease in the sum of the longest diameters (LD) of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of >= 1 non-TL[s]) as the time from the first documented evidence of a CR or PR until the first documentation of radiological PD or death due to breast cancer, if sooner. PD is defined as >=20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of >= 1 new lesions or unequivocal progression of existing non-TLs. For par. who did not progress or die, DoR was censored on the date of the last radiological scan. If a par.had only a Baseline visit or did not have a date of a radiological scan that was later than the date of initiation of anti-cancer therapy, DoR was censored at the start date of treatment.|From the first documented evidence of a PR or CR until the earlier of the date of disease progression or the date of death due to breast cancer (up to Study Week 103)|ITT Population. Only those participants with CR or PR were analyzed (represented by n=X in the category titles). Different participants may have been analyzed by the IRC and the Investigator, so the overall number of participants analyzed reflects everyone in the ITT Population.||Weeks||Inter-Quartile Range|Median
703026|NCT00089999|Secondary|Time to Response, as Assessed by the IRC and Investigator|Time to response is defined as the time from randomization until the first documented evidence of a PR or CR (whichever status is recorded first). Analysis was based on responses confirmed at a repeat assessment made at least 4 weeks after the initial response, with the time to response taken as the first time the response was observed, not the confirmation assessment. Participants who withdraw with no tumor response were censored at the date of withdrawal from the study. CR is defined as the disappearance of all TLs and non-TLs. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL(s). PD is defined as at least a 20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-TLs.|From the date of the first dose of investigational product until the first documented evidence of a PR or CR (up to Study Week 103)|ITT Population. Only those participants with CR or PR were analyzed (represented by n=X in the category titles). Different participants may have been analyzed by the IRC and the Investigator, so the overall number of participants analyzed reflects everyone in the ITT Population.||Weeks||Full Range|Median
703027|NCT00089999|Secondary|Percentage of Participants With Clinical Benefit (CR or PR or Stable Disease [SD] for at Least 24 Weeks), as Assessed by the IRC and Investigator|Clinical benefit is defined as the numer of participants achieving either a confirmed CR (disappearance of all target lesions (TLs) and non-TLs) or PR (at least a 30% decrease in the sum of the longest diameters (LD) of TLs, taking as a reference the Baseline sum LD and no PD,or complete resolution of TLs and the persistence of one or more non-TLs)or SD (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [at least a 20% increase in the sum of the LD of target lesions, taking as a reference, the smallest sum LD recorded since the treatment started or the appearance of 1 or more new TLs or non-TLs and/or unequivocal progressionn of existing non-target lesions], taking as reference, the smallest sum LD since the treatment started) for at least 24 weeks. This was based on confirmed responses from the investigator assessment of clinical benefit.|From the date of the first dose of investigational product until the date of disease progression or death due to breast cancer (up to Study Week 103)|ITT Population||Percentage of Participants|||Number
703028|NCT00089999|Primary|Number of Participants With a Best Overall Response (OR) of Confirmed Complete Response (CR) or Partial Response (PR), as Assessed by the Investigator|OR is defined as the number of participants achieving either a confirmed CR or PR, per Response Evaluation Criteria in Solid Tumors (RECIST, v 1.0). Best OR is defined as the best response recorded from the start of treatment until progressive disease (PD)/recurrence. CR is defined as the disappearance of all target lesions (TLs) and non-TLs. PR is defined as at least a 30% decrease in the sum of the longest diameters (LD) of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL(s), as assessed by the IRC. PD is defined as at least a 20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of >= 1 new lesions or unequivocal progression of existing non-TLs. Responses were confirmed at subsequent assessments made >=28 days after the original response. Participants with an unknown or missing response are treated as non-responders.|From the date of the first dose of investigational product to the first documented evidence of a confirmed CR or PR (up to Study Week 103)|ITT Population||Participants|||Number
703029|NCT00089999|Primary|Number of Participants With a Best Overall Response (OR) of Confirmed Complete Response (CR) or Partial Response (PR), as Assessed by the Independent Review Committee (IRC)|OR is defined as the number of participants achieving either a confirmed CR or PR, per Response Evaluation Criteria in Solid Tumors (RECIST, v 1.0). Best OR is defined as the best response recorded from the start of treatment until progressive disease (PD)/recurrence. CR is defined as the disappearance of all target lesions (TLs) and non-TLs. PR is defined as at least a 30% decrease in the sum of the longest diameters (LD) of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL(s), as assessed by the IRC. PD is defined as at least a 20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of >= 1 new lesions or unequivocal progression of existing non-TLs. Responses were confirmed at subsequent assessments made >=28 days after the original response. Participants with an unknown or missing response are treated as non-responders.|From the date of the first dose of investigational product to the first documented evidence of a confirmed CR or PR (up to Study Week 103)|Intent-to-Treat (ITT) Population: all randomized participants who received at least one dose of investigational product.||Participants|||Number
703030|NCT00090051|Secondary|Final Analysis: Time to New Chronic Lymphocytic Leukemia (CLL) Treatment|Time to new CCL treatment was defined as the time from randomization to the first day of new treatment for CCL or death.|Median observation time was approximately 5 years|Participants from the Intent-to-treat population,all randomized participants, who started a new treatment for CLL or died.||Days||95% Confidence Interval|Median
730388|NCT00388349|Secondary|Overall Survival (OS)|Reports the percentage of participants surviving 6 months after PBSC infusion (transplant).|2 years|All participants||percentage of participants|||Number
703034|NCT00090051|Secondary|Final Analysis: Time to Event-Free Survival Event|Event free survival (EFS) was defined as the time from the day of randomization to the date of first EFS event: documented disease progression, relapse after response, start of a new treatment or death from any cause.|Median observation time was approximately 5 years|Participants from the Intent-to-treat population, all randomized participants, who had an EFS event. Participants who did not have an ESF event at the time of the final analysis were censored at the date of the last contact.||Days||95% Confidence Interval|Median
703035|NCT00090051|Secondary|Final Analysis: Time to Overall Survival Event|Overall survival (OS) was determined from the date of randomization to the date of death (OS event) irrespective of cause.|Median observation time was approximately 5 years|The analysis included only those participants from the Intent-to-treat population,all randomized participants, who died. Participants who had not died at the time of the final analysis were censored at the date of the last contact.||Days||95% Confidence Interval|Median
703036|NCT00090051|Primary|Final Analysis: Time to Progression-Free Survival Event|Time to progression-free survival (PFS) event was defined as the time between randomization and the date of first documented PFS event: disease progression, relapse or death by any cause, whichever came first.|Median observation time was approximately 5 years|Participants from the Intent-to-treat population, all randomized participants, who experienced a PFS event. Participants who did not have a PFS event at the time of the final analysis were censored at the date of the last contact.||Days||95% Confidence Interval|Median
703037|NCT00090051|Secondary|Number of Participants With Disease-free Survival (DFS) Events|Disease free survival was defined for all patients with a best overall response (BOR) of Complete Response (CR) and measured the time from first documented CR in a sequence of consecutive CRs until documented disease progression, relapse or death from any cause (DFS events). Patients without a DFS event at the time of the analysis (clinical data cut-off) were censored at their last tumor assessment date.|Mean observation time at time of analysis was approximately 26 months|Intent-to-treat (ITT) population with a Best Overall Response of Complete Response.||participants|||Number
703038|NCT00090051|Secondary|Disease-free Survival (DFS)|Disease free survival was defined for all patients with a best overall response (BOR) of Complete Response (CR) and measured the time from first documented CR in a sequence of consecutive CRs until documented disease progression, relapse or death from any cause. Patients without a DFS event at the time of the analysis (clinical data cut-off) were censored at their last tumor assessment date.|Mean observation time at time of analysis was approximately 26 months|Intent-to-treat (ITT) population for patients with a Best Overall Response of Complete Response.||Days||95% Confidence Interval|Median
703039|NCT00090051|Primary|Number of Participants With Progression-free Survival (PFS) Events Assessed by the Independent Review Committee (IRC)|Progression-free survival as assessed by the IRC was defined as the time between randomization and the date of first documented disease progression, relapse after response, or death from any cause (PFS events), whichever came first. Patients without a PFS event were censored at their last tumor assessment date.|Mean observation time at time of analysis was approximately 26 months|Intent-to-treat (ITT) population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not.||participants|||Number
703040|NCT00090051|Secondary|Number of Participants With Event-free Survival (EFS) Events|Event free survival was measured from the day of randomization to the date of first documented Progressive Disease (PD), relapse after response, start of a new treatment or death from any cause (EFS events). Patients without an EFS event were censored at their last tumor assessment date.|Mean observation time at time of analysis was approximately 26 months|Intent-to-treat (ITT) population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not.||participants|||Number
703041|NCT00090051|Secondary|Event-free Survival (EFS)|Event free survival was measured from the day of randomization to the date of first documented PD, relapse after response, start of a new treatment or death from any cause. Patients without an EFS event were censored at their last tumor assessment date.|Mean observation time at time of analysis was approximately 26 months|Intent-to-treat (ITT) population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not.||Days||95% Confidence Interval|Median
703042|NCT00090051|Secondary|Number of Participants With Overall Survival (OS) Events|Overall survival was determined from the date of randomization to the date of death (OS event) irrespective of cause. Patients who had not died at the time of the final analysis (clinical data cut-off) were censored at the date of the last contact.|Mean observation time at time of analysis was approximately 26 months|Intent-to-treat (ITT) population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not.||participants|||Number
703043|NCT00090051|Secondary|Overall Survival (OS)|Overall survival was determined from the date of randomization to the date of death irrespective of cause. Patients who had not died at the time of the final analysis (clinical data cut-off) were censored at the date of the last contact.|Mean observation time at time of analysis was approximately 26 months|Intent-to-treat (ITT) population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not.||Days||95% Confidence Interval|Median
703044|NCT00090051|Primary|Progression-free Survival (PFS) as Assessed by the Independent Review Committee (IRC)|Progression-free survival as assessed by the IRC was defined as the time between randomization and the date of first documented disease progression, relapse after response, or death from any cause, whichever came first. Patients without a PFS event were censored at their last tumor assessment date.|Mean observation time at time of analysis was approximately 26 months|Intent-to-treat (ITT) population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not.||Days||95% Confidence Interval|Median
703045|NCT00090103|Secondary|Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 12 (LOCF)|"This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of Would you ask your doctor for the medication you received in this study?."|Baseline and Months 12, 24, 36, and 48|ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.||participants|||Number
703046|NCT00090103|Secondary|Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 11 (LOCF)|"This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of Overall, how satisfied are you with the study medication and it's effect on your urinary problems?. Satisfact., satisfaction."|Baseline and Months 12, 24, 36, and 48|ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.||participants|||Number
703047|NCT00090103|Secondary|Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 10 (LOCF)|"This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of How satisfied are you with the effect the study medication has on your ability to go about your usual activities without interference from your urinary problems?. Satisfact., satisfaction."|Baseline and Months 12, 24, 36, and 48|ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.||participants|||Number
703048|NCT00090103|Secondary|Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 9 (LOCF)|"This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of Since you began taking the study medication, how has the way your urinary problems interfere with your ability to go about your usual activities changed?."|Baseline and Months 12, 24, 36, and 48|ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.||participants|||Number
703049|NCT00090103|Secondary|Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 8 (LOCF)|"This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of How satisfied are you with the effect the study medication has on your pain during urination?. Satisfact., satisfaction."|Baseline and Months 12, 24, 36, and 48|ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.||participants|||Number
703050|NCT00090103|Secondary|Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 7 (LOCF)|"This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of Since you began taking the study medication, how has your pain during urination changed?."|Baseline and Months 12, 24, 36, and 48|ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.||participants|||Number
703051|NCT00090103|Secondary|Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 6 (LOCF)|"This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of How satisfied are you with the effect the study medication has on your pain prior to urinating?. Satisfact., satisfaction."|Baseline and Months 12, 24, 36, and 48|ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.||participants|||Number
703052|NCT00090103|Secondary|Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 5 (LOCF)|"This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of Since you began taking the study medication, how has your pain prior to urinating changed?."|Baseline and Months 12, 24, 36, and 48|ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.||participants|||Number
703053|NCT00090103|Secondary|Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 4 (LOCF)|"This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of How satisfied are you with the effect of the study medication on the strength of your urinary stream?. Satisfact., satisfaction."|Baseline and Months 12, 24, 36, and 48|ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.||participants|||Number
703054|NCT00090103|Secondary|Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 3 (LOCF)|"This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of Since you began taking the study medication, how has the strength of your urinary stream changed?."|Baseline and Months 12, 24, 36, and 48|ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.||participants|||Number
703055|NCT00090103|Secondary|Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 2 (LOCF)|"This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of How satisfied are you with the effect of the study medication on control of your urinary problems? Satisfact., satisfaction."|Baseline and Months 12, 24, 36, and 48|ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.||participants|||Number
703056|NCT00090103|Secondary|Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 1 (LOCF)|"This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of Since you began taking the study medication, how has control of your urinary problems changed?."|Baseline and Months 12, 24, 36, and 48|ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.||participants|||Number
703057|NCT00090103|Secondary|Adjusted Mean Change From Baseline in BPH-Related Health Status (BHS) at Months 12, 24, 36, and 48|The effect of study treatment on BHS was assessed by using three self-administered questionnaires: the International Prostate Symptom Score (IPSS), the BPH Impact Index (BII), and Patient Perception of Study Medication (PPSM). The BHS score was collected on the IPPS questionnaire and ranged from 0 (best) to 6 (worst). Percent change from baseline = [(post-baseline – baseline)/baseline value] x 100. Estimates were based on the adjusted (least squares) means from the general linear model: change from baseline BPH-related health status = treatment + cluster + baseline BPH-Related health status.|Baseline and Months 12, 24, 36, 48|ITT Population. As the study progressed, participants dropped out of the study.||points on a scale||Standard Error|Least Squares Mean
703058|NCT00090103|Secondary|Adjusted Mean Change From Baseline in BPH Impact Index (BII) at Months 12, 24, 36, and 48|The BII is a 4-item questionnaire, score range of 0 (best) to 12 (worst) for questions 1-3, and 0 (best) to 13 (worst) for question 4, that assesses the overall impact of BPH on a participant's general sense of well being and measures aspects of physical discomfort, worry, and bother, all of which can be affected by BPH and its symptoms. BII score = sum of questions 1-4. Change from baseline = Post-Baseline Value. Estimates are based on the adjusted (least squares) means from the general linear model: change from baseline BII = treatment + cluster + baseline BII.|Baseline and Months 12, 24, 36, and 48|ITT Population. As the study progressed, participants dropped out of the study.||points on a scale||Standard Error|Least Squares Mean
703059|NCT00090103|Secondary|Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.)|"At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with unplanned visits to GP/Urologist. Responses to the following question were recorded: Does the participant have any unscheduled GP/Urologist (outpatients) visits planned, not relating to the study (this can include visits resulting from UTI, UI, macroscopic haematuria, etc.?. If the answer to the question was “yes,” the number of visits was recorded."|Every 3 months from Month 3 to Month 48|ITT Population. As study progressed, participants dropped out the study.||visits|||Number
703060|NCT00090103|Secondary|Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.)|"At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with unplanned visits to GP/Urologist. Responses to the following question were recorded: Has the participant had any unplanned GP/Urologist (outpatient) visits that would have taken place if a scheduled study visit had not been planned (this can include visits resulting from UTI, UI macroscopic haematuria, etc?. If the answer to the question was “yes,” the number of visits was recorded."|Every 3 months from Month 3 to Month 48|ITT Population. As study progressed, participants dropped out of the study.||visits|||Number
703061|NCT00090103|Secondary|"Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit?"|"At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with BPH-related surgery. Responses to the following question were recorded: Would the participant have paid a visit to his general practitioner (GP)/Urologist regarding BPH-related surgery since the last study visit?. If the answer to the question was “yes,” the number of Yes responses was recorded."|Every 3 months from Month 3 to Month 48|ITT Population. As study progressed, participants dropped out of study.||yes responses|||Number
703062|NCT00090103|Secondary|Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit|"At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with BPH-related surgery. Responses to the following question were recorded: Has the participant needed to visit his general practitioner (GP)/Urologist regarding BPH-related surgery since the last study visit?. If the answer to the question was “yes,” the number of visits was recorded."|Every 3 months from Month 3 to Month 48|ITT Population. As the study progressed, participants dropped out of the study.||visits|||Number
703063|NCT00090103|Secondary|"Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned?."|"At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with an episode of AUR. Responses to the following question were recorded: Would the participant have paid a visit to his GP/Urologist regarding AUR symptoms if this study visit had not been planned?. If the answer to the question was “yes,” the number of Yes responses was recorded."|Every 3 months from Month 3 to Month 48|ITT Population. As the study progressed, participants dropped out of the study.||yes responses|||Number
703149|NCT00090363|Secondary|Change in Number of Bone Metastases Over Time|Percentage change in the number of bone metastases from baseline to last available post-baseline scan prior to discontinuation.|Baseline to last available post-baseline scan prior to discontinuation, up to maximum of 1164 days.|||Percentage Change||Standard Deviation|Mean
703064|NCT00090103|Secondary|Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit|"At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with an episode of AUR. Responses to the following question were recorded: Has the participant needed to make any unscheduled visits to his general practitioner (GP)/Urologist regarding AUR symptoms since the last study visit? If the answer to the question was “yes,” the number of visits was recorded."|Every 3 months from Month 3 to Month 48|ITT Population. As the study progressed, participants dropped out of the study.||visits|||Number
703065|NCT00090103|Secondary|Adjusted Mean Change From Baseline in Transition Zone (Portion of the Prostate That Surrounds the Proximal Urethra) Volume at Months 12, 24, 36, and 48|Prostate volume (PV) measurements were conducted annually using Transurethral ultrasound (TRUS). The anteroposterior, cephalocaudal, and transverse diameters of the prostate obtained by TRUS calculate the total PV in centimeters (cc). Results are for the transition zone measurements of the prostate in a small subset of participants. Percent change from baseline (BL) = [(post-BL - BL)/BL value] x 100. Estimates are based on the adjusted (least squares) means for the general linear model: log(post-BL/BL value) = treatment + cluster + log(BL value) and are reported as percent change from BL.|Baseline and Months 12, 24, 36, and 48|ITT Population. As the study progressed, participants dropped out of the study. Transition zone measurements were only done on a subset of participants at sites with experience in measuring the transition zone of the prostate. Also, transition zone measurements were either not performed or missing for some participants at various timepoints.||percent change||Standard Error|Least Squares Mean
703066|NCT00090103|Secondary|Adjusted Mean Percent Change From Baseline in Prostate Volume at Months 12, 24, 36, and 48|Prostate volume measurements were conducted annually using Transurethral ultrasound (TRUS). The anteroposterior, cephalocaudal, and transverse diameters of the prostate obtained by TRUS calculate the total prostate volume centimeters (cc). Percent change from baseline = [(post-baseline - baseline)/baseline value] x 100. Estimates were based on the adjusted (least squares) means from the general linear model: log(post-baseline/baseline value) + treatment + cluster + log(baseline value) and are reported as percent change from baseline.|Baseline and Months 12, 24, 36, and 48|ITT Population. As the study progressed, participants dropped out of the study. Also, prostate measurements were either not performed or missing for some participants at various timepoints.||percent change||Standard Error|Least Squares Mean
703067|NCT00090103|Secondary|Adjusted Mean Change From Baseline in Urinary Flow Rate (Qmax) at Months 12, 24, 36, and 48|Peak maximum urinary flow (Qmax) of urinary flow using a Medtronic (formerly Dantec) Uroflow Meter (Urodyn 1000 or Duet models) with a Thompson filter was measured. Estimates are based on adjusted (least squares) means from the general linear model: Change from baseline Qmax = treatment + cluster + baseline Qmax.|Baseline and Months 12, 24, 36, and 48|ITT Population. As the study progressed, participants dropped out of the study. Also, assessments with voided volumes <125 ml were not included in the analysis.||milliliters (mL)/second (sec)||Standard Error|Least Squares Mean
703068|NCT00090103|Secondary|Adjusted Mean Change From Baseline in International Prostate Symptom Score (IPSS) at Months 12, 24, 36, and 48|The IPSS is a 7-item questionnaire that measures urinary symptoms. It measures the level of urinary symptoms (including incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia) reported as the total IPSS score. Each of the 7 questions has a 6-point response scale (0=none/not at all to 5=almost always) with a total score that can range from 0-35: mild (0-7), moderate (8-19), or severe (20-35). Estimates are based on adjusted (least squares) means from the general linear model: change from baseline IPSS = Treatment + Cluster + Baseline IPSS.|Baseline and Months 12, 24, 36, and 48|ITT Population. As the study progressed, participants dropped out of the study.||points on a scale||Standard Error|Least Squares Mean
703069|NCT00090103|Secondary|Number of Participants With an Event of Post-baseline BPH-related Hematospermia|A participant was considered to have hematospermia when there was presence of blood in the semen. Hematospermia can occur from prostatitis (prostate infection), from cancer, or after a prostate biopsy. The event of hematospermia was either participant-reported or identified by the investigator during a clinic visit. Overall Crude Rate is the number of participants from the total number analyzed that experience experienced an incident of post-baseline BPH or Non-BPH related hematospermia. Participants may appear in both categories.|Baseline (Day 1) through Year 4|ITT Population||participants|||Number
703070|NCT00090103|Secondary|Number of Participants With an Event of Post-baseline BPH-related Macroscopic Hematuria|A participant was considered to have macroscopic hematuria when there was presence of blood in the urine. The event of macroscopic hematuria was either participant-reported or identified by the investigator during a clinic visit. Overall Crude Rate is the number of participants from the total number analyzed that experience experienced an incident of post-baseline BPH or Non-BPH related macroscopic hematuria. Participants may appear in both categories.|Baseline (Day 1) through Year 4|ITT Population||participants|||Number
703071|NCT00090103|Secondary|Number of Events of Symptom Deterioration at the Indicated Time Periods|The number of participants (par.) with symptom deterioration of International Prostate Symptom Score (IPSS) ≥4 points on two consecutive visits post-baseline are presented. Data are based on the first occurrence of an event after treatment start. The year-4 events include all that occured during the 4th year and beyond. The IPSS is a 7-item questionnaire measuring the level of urinary symptoms reported as the total score. Each question has a 6-point response scale (0=none/not at all to 5=almost always), with a total score ranging from 0-35: mild (0-7), moderate (8-19), or severe (20-35).|Years 1, 2, 3, and 4 (from treatment start until each participant's last treatment-phase visit)|Intent-to-Treat (ITT) Population: all participants randomized to the double-blind treatment period. As the study progressed, participants dropped out of the study.||events|||Number
703072|NCT00090103|Secondary|The Number of Participants With Each of the Five Components of BPH Clinical Progression|The five components measured were symptom deterioration, BPH-related AUR, BPH-related incontinence, recurrent BPH-related Urinary Tract Infection (UTI), and BPH-related renal insufficiency.|Baseline (Day 1) to Year 4|ITT Population||participants|||Number
703073|NCT00090103|Primary|Number of Participants With AUR or BPH-related Surgery|A participant was considered to have AUR when he was unable to urinate and required bladder catheterization. BPH is also known as an enlarged prostate. When symptoms of BPH become bothersome, surgery may be required. When events of AUR and BPH-related surgery were participant reported or identified, they were recorded in the participants' clinic record.|Baseline (Day 1) through Year 4|ITT Population||participants|||Number
703075|NCT00090103|Primary|Number of Events of Acute Urinary Retention (AUR) or Benign Prostatic Hyperplasia (BPH)-Related Prostatic Surgery at the Indicated Time Periods.|A participant was considered to have AUR when he was unable to urinate and required bladder catheterization. BPH is also known as an enlarged prostate. When symptoms of BPH become bothersome, surgery may be required. When events of AUR and BPH-related surgery were participant-reported or identified, they were recorded in the participants' clinic record.|Years 1, 2, 3, and 4|Intent-to-Treat (ITT) Population: all participants randomized to the double-blind treatment period. As the study progressed, participants dropped out of the study.||events|||Number
703076|NCT00090142|Secondary|Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 24 Hours Postdose|The time to recovery from maximum percent fall is the duration between the time at which the maximum percent fall in FEV1 after exercise challenge occurs and the time when FEV1 returns to within 5% of the preexercise baseline for the first time.|Exercise challenge at 24 hours postdose|The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.||Minutes||Standard Deviation|Mean
703077|NCT00090142|Secondary|Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 12 Hours Postdose|The time to recovery from maximum percent fall is the duration between the time at which the maximum percent fall in FEV1 after exercise challenge occurs and the time when FEV1 returns to within 5% of the preexercise baseline for the first time.|Exercise challenge at 12 hours postdose|The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.||Minutes||Standard Deviation|Mean
703078|NCT00090142|Secondary|Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 2 Hours Postdose|The time to recovery from maximum percent fall is the duration between the time at which the maximum percent fall in FEV1 after exercise challenge occurs and the time when FEV1 returns to within 5% of the preexercise baseline for the first time.|Exercise challenge at 2 hours postdose|The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.||Minutes||Standard Deviation|Mean
703079|NCT00090142|Secondary|Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60min) at 24 Hours Postdose|The measure included only the area below the pre-exercise baseline.|Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 24 hours postdose|The secondary efficacy analysis was an MITT approach. If a patient received β-agonist rescue medication during the 60 minutes following exercise challenge, then the last pre-rescue FEV1 measurement was carried forward to 60 minutes. Patients with data from only one period were not included in the analysis.||(percent change) *minutes||Standard Deviation|Mean
703080|NCT00090142|Secondary|Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60 Min) at 12 Hours Postdose|The measure included only the area below the pre-exercise baseline.|Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 12 hours postdose|The secondary efficacy analysis used a MITT approach. If a patient received β-agonist rescue medication during the 60 minutes following exercise challenge, then the last pre-rescue FEV1 measurement was carried forward to 60 minutes. Patients with data from only one period were not included in the analysis.||(percent change) *minutes||Standard Deviation|Mean
703081|NCT00090142|Secondary|Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60 Min) at 2 Hours Postdose|The measure included only the area below the pre-exercise baseline.|Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 2 hours postdose|The secondary efficacy analysis used a MITT approach. If a patient received β-agonist rescue medication during the 60 minutes following exercise challenge, then the last pre-rescue FEV1 measurement was carried forward to 60 minutes. Patients with data from only one period were not included in the analysis.||(percent change) *minutes||Standard Deviation|Mean
703082|NCT00090142|Secondary|Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Postdose Compared With Pre-exercise Baseline in Patients With EIB|In patients with EIB, the percent change from pre-exercise baseline FEV, to the lowest FEV1 within 60 minutes after exercise challenge (24 hours post-dose). The FEV1 measurement obtained 5 minutes before the exercise challenge was the baseline, and was specific to each exercise challenge.|Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 24 hours after a single oral dose|The primary efficacy analysis used the modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.||Percent Change||Standard Deviation|Mean
703083|NCT00090142|Secondary|Maximum Percent Fall in FEV1 After Exercise Challenge at 12 Hours Postdose Compared With Pre-exercise Baseline in Patients With EIB|In patients with EIB, the percent change from pre-exercise baseline FEV, to the lowest FEV1 within 60 minutes after exercise challenge (12 hours post-dose). The FEV1 measurement obtained 5 minutes before the exercise challenge was the baseline, and was specific to each exercise challenge.|Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 12 hours after a single oral dose|The primary efficacy analysis used the modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.||Percent Change||Standard Deviation|Mean
703084|NCT00090142|Secondary|Number of Patients Requiring ß-Agonist Rescue Medication After Exercise Challenge at 24 Hours Postdose||0-90 minutes after the exercise challenge performed at 24 hours postdose|The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.||Participants|||Number
703085|NCT00090142|Secondary|Number of Patients Requiring ß-Agonist Rescue Medication After Exercise Challenge at 12 Hours Postdose||0-90 minutes after the exercise challenge performed at 12 hours postdose|"The secondary efficacy analysis used a modified
intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis."||Participants|||Number
703086|NCT00090142|Secondary|Number of Patients Requiring ß-Agonist Rescue Medication After Exercise Challenge at 2 Hours Postdose||0-90 minutes after the exercise challenge performed at 2 hours postdose|"The secondary efficacy analysis used a modified
intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis."||Participants|||Number
731766|NCT00399542|Secondary|Month 2 Stool Consistency Change From Baseline|0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)|28 days|ITT with LOCF||units on a scale||Standard Deviation|Mean
703087|NCT00090142|Primary|Maximum Percent Fall in FEV1 After Exercise Challenge at 2 Hours Post-dose Compared With Pre-exercise Baseline in Patients With Exercise-induced Bronchospasm (EIB)|In patients with EIB, the percent change from pre-exercise baseline FEV, to the lowest FEV1 within 60 minutes after exercise challenge (2 hours post-dose). The FEV1 measurement obtained 5 minutes before the exercise challenge was the baseline, and was specific to each exercise challenge.|Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 2 hours after a single oral dose|The primary efficacy analysis used the modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.||Percent Change||Standard Deviation|Mean
703088|NCT00090220|Other Pre-specified|Incidence Rate of HPV 16/18-related CIN 2 or Worse (Secondary Analysis): Year 6 to 10|The four HPV types were determined by PCR testing.|From 72 to 120 months (6 to 10 years) after the first dose of qHPV vaccine in the Base Study|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 6. This Outcome Measure applied only to participants who received qHPV in the Base Study.||Incidence per 100 person-years||95% Confidence Interval|Number
703089|NCT00090220|Other Pre-specified|Incidence Rate of HPV 16/18-related CIN 2 or Worse (Secondary Analysis): Year 4 to 8|The four HPV types were determined by PCR testing. The analysis windows were cut at the exact time points, e.g., Year 4. Visits and events which occurred after Year 4 due to visit window or follow-up investigations are included in the Year 4 to Year 8 time interval.|From 48 to 96 months (4 to 8 years) after the first dose of qHPV vaccine in the Base Study|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 4. This Outcome Measure applied only to participants who received qHPV in the Base Study.||Incidence per 100 person-years||95% Confidence Interval|Number
703090|NCT00090220|Other Pre-specified|Incidence Rate of HPV 16/18-related CIN 2 or Worse (Secondary Analysis): Day 1 to Year 4|The four HPV types were determined by PCR testing.|Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study)|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data.||Incidence per 100 person-years||95% Confidence Interval|Number
703091|NCT00090220|Other Pre-specified|Cumulative Incidence of HPV 16/18-related CIN 2 or Worse: Year 6 to 10|The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Year 6 to Year 10 conditional on having been event-free from Day 1 to Year 6.|From 72 to 120 months (6 to 10 years) after the first dose of qHPV vaccine in the Base Study|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 6. This Outcome Measure applied only to participants who received qHPV in the Base Study.||Cumulative Incidence Probability||95% Confidence Interval|Number
703092|NCT00090220|Other Pre-specified|Cumulative Incidence of HPV 16/18-related CIN 2 or Worse: Year 4 to 8|The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Year 4 to Year 8 conditional on having been event-free from Day 1 to Year 4. The analysis windows were cut at the exact time points, e.g., Year 4. Visits and events which occurred after Year 4 due to visit window or follow-up investigations are included in the Year 4 to Year 8 time interval.|From 48 to 96 months (4 to 8 years) after the first dose of qHPV vaccine in the Base Study|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 4. This Outcome Measure applied only to participants who received qHPV in the Base Study.||Cumulative Incidence Probability||95% Confidence Interval|Number
703093|NCT00090220|Other Pre-specified|Cumulative Incidence of HPV 16/18-related CIN 2 or Worse: Day 1 to Year 4|The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Day 1 to Year 4 conditional on having been event-free at Day 1.|Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study)|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data.||Cumulative Incidence Probability||95% Confidence Interval|Number
703094|NCT00090220|Other Pre-specified|Incidence Rate of HPV 16/18 Related Persistent Infection, Genital Warts, VIN, VaIN, Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, Cervical AIS, and Cervical Cancer|HPV 16/18: The two types of HPV (types 16/18) were determined by PCR testing|Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study)|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the relevant HPV type at Day 1 and PCR negative to the relevant HPV type Day 1 through Month 7, and provided follow-up data after Month 7||Incidence per 100 person-years|||Number
703095|NCT00090220|Secondary|Incidence Rate of HPV 31/33/35/52/58 Related Persistent Infection, Genital Warts, VIN, VaIN, Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, Cervical AIS, and Cervical Cancer|This outcome measure was not analyzed because of diminished interest by experts in composite efficacy endpoints associated with these HPV types|Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study)||||||
703096|NCT00090220|Secondary|Incidence Rate of HPV 6/11-related Condyloma (Secondary Analysis): Year 6 to Year 10|The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Year 6 to Year 10 conditional on having been event-free from Day 1 to Year 6.|From 72 to 120 months (6 to 10 years) after the first dose of qHPV vaccine in the Base Study|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 6. This Outcome Measure applied only to participants who received qHPV in the Base Study.||Incidence per 100 person-years||95% Confidence Interval|Number
703175|NCT00090584|Secondary|Symptom Distress|Urogenital distress inventory (UDI). Higher score indicates greater distress. Possible range 0 to 300.|baseline, 10 weeks and 8 months|All women who completed UDI at each time in each treatment group||units on a scale||Standard Deviation|Mean
731767|NCT00399542|Secondary|Month 3 Spontaneous Bowel Movement Rates Change From Baseline|Any bowel movement not associated with rescue medication use|28 days|ITT with LOCF||SBMs/week||Standard Deviation|Mean
703097|NCT00090220|Secondary|Incidence Rate of HPV 6/11-related Condyloma (Secondary Analysis): Year 4 to Year 8|The four HPV types were determined by PCR testing. The analysis windows were cut at the exact time points, e.g., Year 4. Visits and events which occurred after Year 4 due to visit window or follow-up investigations are included in the Year 4 to Year 8 time interval.|From 48 to 96 months (4 to 8 years) after the first dose of qHPV vaccine in the Base Study|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 4. This Outcome Measure applied only to participants who received qHPV in the Base Study.||Incidence per 100 person-years||95% Confidence Interval|Number
703098|NCT00090220|Secondary|Incidence Rate of HPV 6/11-related Condyloma (Secondary Analysis): Day 1 to Year 4|The four HPV types were determined by PCR testing.|Up to 48 months (4 years) after the first dose of qHPV vaccine or placebo in the Base Study|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data.||Incidence per 100 person-years||95% Confidence Interval|Number
703099|NCT00090220|Secondary|Cumulative Incidence of HPV 6/11-related Condyloma: Year 6 to Year 10|The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Year 6 to Year 10 conditional on having been event-free from Day 1 to Year 6.|From 72 to 120 months (6 to 10 years) after the first dose of qHPV vaccine in the Base Study|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 6. This Outcome Measure applied only to participants who received qHPV in the Base Study.||Cumulative Incidence Probability||95% Confidence Interval|Number
703100|NCT00090220|Secondary|Cumulative Incidence of HPV 6/11-related Condyloma: Year 4 to Year 8|The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Year 4 to Year 8 conditional on having been event-free from Day 1 to Year 4. The analysis windows were cut at the exact time points, e.g., Year 4. Visits and events which occurred after Year 4 due to visit window or follow-up investigations are included in the Year 4 to Year 8 time interval.|From 48 to 96 months (4 to 8 years) after the first dose of qHPV vaccine in the Base Study|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 4. This Outcome Measure applied only to participants who received qHPV in the Base Study.||Cumulative Incidence Probability||95% Confidence Interval|Number
703101|NCT00090220|Secondary|Cumulative Incidence of HPV 6/11-related Condyloma: Day 1 to Year 4|The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Day 1 to Year 4 conditional on having been event-free at Day 1.|Up to 48 months (4 years) after the first dose of qHPV vaccine or placebo in the Base Study|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data.||Cumulative Incidence Probability||95% Confidence Interval|Number
703102|NCT00090220|Secondary|Incidence Rate of HPV 6/11 Related Persistent Infection, Genital Warts, VIN, VaIN, Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, Cervical AIS, and Cervical Cancer|HPV 6/11: The two types of HPV (types 6/11) were determined by PCR testing|Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study)|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the relevant HPV type at Day 1 and PCR negative to the relevant HPV type Day 1 through Month 7, and provided follow-up data after Month 7||Incidence per 100 person-years|||Number
703103|NCT00090220|Primary|Percentage of Participants Seropositive for Anti-HPV Antibody at 114 Months Postdose 3 in the Base Study|Serum antibodies to HPV Types 6, 11, 16, and 18 were determined by Competitive Luminex Immunoassay (cLIA). The seropositive thresholds (in mMU/mL) were >20 for Type 6, >16 for Type 11, >20 for Type 16, and >24 for Type 18. This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.|Month 120 (114 months after the third dose of qHPV vaccine in the Base Study)|Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.||Percentage of participants||95% Confidence Interval|Number
703104|NCT00090220|Primary|Percentage of Participants Seropositive for Anti-HPV Antibody at 90 Months Postdose 3 in the Base Study|Serum antibodies to HPV Types 6, 11, 16, and 18 were determined by Competitive Luminex Immunoassay (cLIA). The seropositive thresholds (in mMU/mL) were >20 for Type 6, >16 for Type 11, >20 for Type 16, and >24 for Type 18. This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.|Month 96 (96 months after the third dose of qHPV vaccine in the Base Study)|Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.||Percentage of participants||95% Confidence Interval|Number
703105|NCT00090220|Primary|Percentage of Participants Seropositive for Anti-HPV Antibody at 66 Months Postdose 3 in the Base Study|Serum antibodies to HPV Types 6, 11, 16, and 18 were determined by Competitive Luminex Immunoassay (cLIA). The seropositive thresholds (in mMU/mL) were >20 for Type 6, >16 for Type 11, >20 for Type 16, and >24 for Type 18. This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.|Month 72 (66 months after the third dose of qHPV vaccine in the Base Study)|Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.||Percentage of participants||95% Confidence Interval|Number
703176|NCT00090584|Secondary|Change in Voids Per Day|Change from baseline to 10 weeks in frequency of voids per day as reported on bladder diary|baseline and 10 weeks|All women with valid bladder diary at baseline and 10 weeks in each treatment group.||voids per day||Standard Error|Mean
703106|NCT00090220|Primary|Percentage of Participants Seropositive for Anti-HPV Antibody at 42 Months Postdose 3 in the Base Study|Serum antibodies to HPV Types 6, 11, 16, and 18 were determined by Competitive Luminex Immunoassay (cLIA). The seropositive thresholds (in mMU/mL) were >20 for Type 6, >16 for Type 11, >20 for Type 16, and >24 for Type 18. This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.|Month 48 (42 months after the third dose of qHPV vaccine in the Base Study)|Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.||Percentage of participants||95% Confidence Interval|Number
703107|NCT00090220|Primary|Percentage of Participants Seropositive for Anti-HPV Antibody at 30 Months Postdose 3 in the Base Study|Serum antibodies to HPV Types 6, 11, 16, and 18 were determined by Competitive Luminex Immunoassay (cLIA). The seropositive thresholds (in mMU/mL) were >20 for Type 6, >16 for Type 11, >20 for Type 16, and >24 for Type 18. This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.|Month 36 (30 months after the third dose of qHPV vaccine in the Base Study)|Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.||Percentage of participants||95% Confidence Interval|Number
703108|NCT00090220|Primary|Percentage of Participants Seropositive for Anti-HPV Antibody at 18 Months Postdose 3 in the Base Study|Serum antibodies to HPV Types 6, 11, 16, and 18 were determined by Competitive Luminex Immunoassay (cLIA). The seropositive thresholds (in mMU/mL) were >20 for Type 6, >16 for Type 11, >20 for Type 16, and >24 for Type 18. This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.|Month 24 (18 months after the third dose of qHPV vaccine in the Base Study)|Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.||Percentage of participants||95% Confidence Interval|Number
703109|NCT00090220|Primary|Percentage of Participants Seropositive for Anti-HPV Antibody at 6 Months Postdose 3 in the Base Study|Serum antibodies to HPV Types 6, 11, 16, and 18 were determined by Competitive Luminex Immunoassay (cLIA). The seropositive thresholds (in mMU/mL) were >20 for Type 6, >16 for Type 11, >20 for Type 16, and >24 for Type 18. This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.|Month 12 (6 months after the third dose of qHPV vaccine in the Base Study)|Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.||Percentage of participants||95% Confidence Interval|Number
703110|NCT00090220|Primary|Percentage of Participants Seropositive for Anti-HPV Antibody at 1 Month Postdose 3 in the Base Study|Serum antibodies to HPV Types 6, 11, 16, and 18 were determined by Competitive Luminex Immunoassay (cLIA). The seropositive thresholds (in mMU/mL) were >20 for Type 6, >16 for Type 11, >20 for Type 16, and >24 for Type 18. This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.|Month 7 (1 month after the third dose of qHPV vaccine in the Base Study)|Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.||Percentage of participants||95% Confidence Interval|Number
703111|NCT00090220|Primary|Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 114 Months Postdose 3 in the Base Study|Serum antibodies to the HPV Types were determined by Competitive Luminex Immunoassay (cLIA). Geometric Mean Titers (GMT) are reported in milli-Merck Units/mL (mMU/mL). This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.|Month 120 (114 months after the third dose of qHPV vaccine in the Base Study)|Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.||mMU/mL||95% Confidence Interval|Geometric Mean
703112|NCT00090220|Primary|Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 90 Months Postdose 3 in the Base Study|Serum antibodies to the HPV Types were determined by Competitive Luminex Immunoassay (cLIA). Geometric Mean Titers (GMT) are reported in milli-Merck Units/mL (mMU/mL). This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.|Month 96 (90 months after the third dose of qHPV vaccine in the Base Study)|Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.||mMU/mL||95% Confidence Interval|Geometric Mean
703113|NCT00090220|Primary|Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 66 Months Postdose 3 in the Base Study|Serum antibodies to the HPV Types were determined by Competitive Luminex Immunoassay (cLIA). Geometric Mean Titers (GMT) are reported in milli-Merck Units/mL (mMU/mL). This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.|Month 72 (66 months after the third dose of qHPV vaccine in the Base Study)|Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.||mMU/mL||95% Confidence Interval|Geometric Mean
703177|NCT00090584|Secondary|Change in Incontinence Episodes|Change from baseline to 10 weeks in number of incontinence episodes per week as reported on bladder diary.|Baseline and 10 weeks|All women with valid bladder diary at baseline and 10 weeks in each treatment group.||incontinence episodes per week||Standard Error|Mean
703114|NCT00090220|Primary|Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 42 Months Postdose 3 in the Base Study|Serum antibodies to the HPV Types were determined by Competitive Luminex Immunoassay (cLIA). Geometric Mean Titers (GMT) are reported in milli-Merck Units/mL (mMU/mL). This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.|Month 48 (42 months after the third dose of qHPV vaccine in the Base Study)|Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.||mMU/mL||95% Confidence Interval|Geometric Mean
703115|NCT00090220|Primary|Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 30 Months Postdose 3 in the Base Study|Serum antibodies to the HPV Types were determined by Competitive Luminex Immunoassay (cLIA). Geometric Mean Titers (GMT) are reported in milli-Merck Units/mL (mMU/mL). This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.|Month 36 (30 months after the third dose of qHPV vaccine in the Base Study)|Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.||mMU/mL||95% Confidence Interval|Geometric Mean
703116|NCT00090220|Primary|Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 18 Months Postdose 3 in the Base Study|Serum antibodies to the HPV Types were determined by Competitive Luminex Immunoassay (cLIA). Geometric Mean Titers (GMT) are reported in milli-Merck Units/mL (mMU/mL). This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.|Month 24 (18 months after the third dose of qHPV vaccine in the Base Study)|Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.||mMU/mL||95% Confidence Interval|Geometric Mean
703117|NCT00090220|Primary|Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 6 Months Postdose 3 in the Base Study|Serum antibodies to the HPV Types were determined by Competitive Luminex Immunoassay (cLIA). Geometric Mean Titers (GMT) are reported in milli-Merck Units/mL (mMU/mL). This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.|Month 12 (6 months after the third dose of qHPV vaccine in the Base Study)|Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.||mMU/mL||95% Confidence Interval|Geometric Mean
703118|NCT00090220|Primary|Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 1 Month Postdose 3 in the Base Study|Serum antibodies to the HPV Types were determined by Competitive Luminex Immunoassay (cLIA). Geometric Mean Titers (GMT) are reported in milli-Merck Units/mL (mMU/mL). This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.|Month 7 (1 month after the third dose of qHPV vaccine in the Base Study)|Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.||mMU/mL||95% Confidence Interval|Geometric Mean
703119|NCT00090220|Primary|Incidence Rate of HPV 6/11/16/18-related CIN or Condyloma (Secondary Analysis): Year 6 to 10|The four HPV types were determined by PCR testing.|From 72 to 120 months (6 to 10 years) after the first dose of qHPV vaccine in the Base Study|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 6. This Outcome Measure applied only to participants who received qHPV in the Base Study.||Incidence per 100 person-years||95% Confidence Interval|Number
703120|NCT00090220|Primary|Incidence Rate of HPV 6/11/16/18-related CIN or Condyloma (Secondary Analysis): Year 4 to 8|The four HPV types were determined by PCR testing. The analysis windows were cut at the exact time points, e.g., Year 4. Visits and events which occurred after Year 4 due to visit window or follow-up investigations are included in the Year 4 to Year 8 time interval.|From 48 to 96 months (4 to 8 years) after the first dose of qHPV vaccine in the Base Study|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 4. This Outcome Measure applied only to participants who received qHPV in the Base Study.||Incidence per 100 person-years||95% Confidence Interval|Number
703121|NCT00090220|Primary|Incidence Rate of HPV 6/11/16/18-related CIN or Condyloma (Secondary Analysis): Day 1 to Year 4|The four HPV types were determined by PCR testing.|Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study)|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data.||Incidence per 100 person-years||95% Confidence Interval|Number
703122|NCT00090220|Primary|Cumulative Incidence of HPV 6/11/16/18-related CIN or Condyloma: Year 6 to 10|The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Year 6 to Year 10, conditional on having been event-free from Day 1 to Year 6.|From 72 to 120 months (6 to 10 years) after the first dose of qHPV vaccine in the Base Study|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 6. This Outcome Measure applied only to participants who received qHPV in the Base Study.||Cumulative Incidence Probability||95% Confidence Interval|Number
703178|NCT00090584|Primary|Proportion of Women Who Meet Definition of Success|Proportion of women who meet definition of success: not taking drug or receiving other urge UI therapy (i.e., neuromodulation, botox injections, myomectomy, electrical stimulation, or any intravesical therapy) and not taking a tricyclic antidepressant or duloxetine at 8 months; and a >70% reduction in number of incontinence episodes as compared to baseline.|8 months|All women who completed the 8 months assessment or were known to return to drug use prior to that time.||participants|||Number
703123|NCT00090220|Primary|Cumulative Incidence of HPV 6/11/16/18-related CIN or Condyloma: Year 4 to 8|The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Year 4 to Year 8, conditional on having been event-free from Day 1 to Year 4. The analysis windows were cut at the exact time points, e.g., Year 4. Visits and events which occurred after Year 4 due to visit window or follow-up investigations are included in the Year 4 to Year 8 time interval.|From 48 to 96 months (4 to 8 years) after the first dose of qHPV vaccine in the Base Study|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 4. This Outcome Measure applied only to participants who received qHPV in the Base Study.||Cumulative Incidence Probability||95% Confidence Interval|Number
703124|NCT00090220|Primary|Cumulative Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia (CIN) or Condyloma: Day 1 to Year 4|The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Day 1 to Year 4, conditional on having been event-free at Day 1.|Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study)|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data.||Cumulative Incidence Probability||95% Confidence Interval|Number
703125|NCT00090220|Primary|Number of Participants With an SAE Resulting in Death After Vaccine Administration|An adverse event (AE) is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse event. A serious adverse event (SAE) is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is a cancer, or is an overdose.|qHPV in Base Study: Up to Month 120; Placebo in Base Study: approximately Month 60 up to Month 120|Participants who received >=1 qHPV vaccination in the Base Study or EXT1 and had safety follow-up||Participants|||Number
703126|NCT00090220|Primary|Number of Participants With Vaccine-Related SAEs After Vaccine Administration|An adverse event (AE) is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse event. A serious adverse event (SAE) is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is a cancer, or is an overdose. Vaccine-related SAEs are those deemed by the investigator to be definitely, probably, or possibly related to study vaccine.|qHPV in Base Study: Up to Month 120; Placebo in Base Study: approximately Month 60 up to Month 120|Participants who received >=1 qHPV vaccination in the Base Study or EXT1 and had safety follow-up||Participants|||Number
703127|NCT00090220|Primary|Number of Participants With Vaccine- or Placebo-Related Serious Adverse Events (SAEs) in the Base Study|An adverse event (AE) is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse event. A serious adverse event (SAE) is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is a cancer, or is an overdose. Vaccine-related SAEs are those deemed by the investigator to be definitely, probably, or possibly related to study vaccine.|Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study)|Participants who received >=1 qHPV vaccination or placebo injection in the Base Study and had safety follow-up||Participants|||Number
703128|NCT00090220|Primary|Incidence Rate of HPV 6/11/16/18 Related Persistent Infection, Genital Warts, VIN, VaIN, Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, Cervical AIS, and Cervical Cancer|The four HPV types were determined by polymerase chain reaction (PCR) testing. VIN = vulvar intraepithelial neoplasia; VaIN = vaginal intraepithelial neoplasia; AIS = adenocarcinoma in situ.|Up to 48 months (4 years) after the first dose of qHPV vaccine in the Base Study|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the relevant HPV type at Day 1 and PCR negative to the relevant HPV type Day 1 through Month 7, and provided follow-up data after Month 7||Incidence per 100 person-years|||Number
703129|NCT00090233|Secondary|Geometric Mean Antibody Titer(s) (GMT) to Pneumococcal Serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F|Measurement of immune response in the group that received RotaTeq™ and the group that received placebo was performed by determining geometric mean antibody titers to pneumococcal serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. Serum antibody titers to type-specific pneumococcal polysaccharides were determined by an EIA.|42 days following third dose|Per Protocol Population; excluding protocol violators and participants with invalid data based on laboratory determinations.||micrograms/mL||95% Confidence Interval|Geometric Mean
703130|NCT00090233|Secondary|Geometric Mean Antibody Titer(s) (GMT) to Pertussis Toxin (PT), Pertussis Filamentous Haemagglutinin (FHA), and Pertussis Pertactin|Measurement of immune response in the group that received RotaTeq™ and the group that received placebo was performed by determining geometric mean antibody titers to Pertussis Toxin (PT), Pertussis Filamentous Haemagglutinin (FHA), and Pertussis Pertactin. Antibody titers were measured with an indirect, non-competitive, enzyme immunoassay (EIA).|42 days following third dose|Per Protocol Population; excluding protocol violators and participants with invalid data based on laboratory determinations.||ELISA units/mL||95% Confidence Interval|Geometric Mean
703131|NCT00090233|Secondary|Seroprotection/Seroconversion for Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus, & Polio Types 1,2,& 3 Who Received COMVAX™, INFANRIX™, IPOL™ & PREVNAR™ Concomitantly With RotaTeq™ Versus Placebo|The number of participants who achieved seroprotection/seroconversion to hepatitis B, Haemophilus influenzae type b, diphtheria, tetanus, & polio types 1, 2, & 3, per established criteria.|42 days following third dose|Per Protocol Population||Participants|||Number
703179|NCT00090610|Secondary|Median Overall Survival||Every 6 months starting at 12 months, to 24 months|||months||95% Confidence Interval|Median
703205|NCT00081289|Secondary|Incidence of Hematologic and Non-hematologic Grade 3-4 Toxicity (Preoperatively, Postoperatively, and Overall)||Three time frames: start of treatment to surgery, surgery to end of follow-up, and combined.||||||
703132|NCT00090233|Secondary|Efficacy of a 3-dose Regimen of RotaTeq™ Against Severe Rotavirus Disease (Clinical Score > 16) Caused by Serotypes G1, G2, G3, and G4 Occurring at Least 14 Days Following the Third Dose|Number of participants with rotavirus gastroenteritis whose clinical score was >16 for the first episode and for the worst episode. Scores evaluated the intensity and duration of diarrhea, vomiting, fever, and behavioral symptoms. The total score for an episode is equal to the sum of the scores for each of the symptoms [range: total score 0 (best) to 24 (worst)].|At least 14 days following the 3rd vaccination through the first rotavirus season|Per Protocol Population Using Per-Protocol Case Definition||Participants|||Number
703133|NCT00090233|Secondary|Efficacy of a 3-dose Regimen of RotaTeq™ Against Moderate-to-severe Rotavirus Disease (Clinical Score >8) Caused by Serotypes G1, G2, G3, and G4 Occurring at Least 14 Days Following the Third Dose.|Number of participants with rotavirus gastroenteritis whose clinical score was >8 for the first episode and for the worst episode. Scores evaluated the intensity and duration of diarrhea, vomiting, fever, and behavioral symptoms. The total score for an episode is equal to the sum of the scores for each of the symptoms [range: total score 0 (best) to 24 (worst)].|At least 14 days following the 3rd vaccination through the first rotavirus season|Per Protocol Population Using Per-Protocol Case Definition||Participants|||Number
703134|NCT00090233|Secondary|Occurrence of Hospital Admissions and Visits to Emergency Departments (or the Equivalent at International Sites) for Rotavirus Disease Associated With Serotypes G1, G2, G3, or G4|Health Outcomes Substudy – Occurrence of hospital admissions and emergency department visits for episode(s) of rotavirus gastroenteritis associated with serotypes G1, G2, G3, or G4 by treatment group. Occurrence was expressed as the annual number of events per 1000 person-years.|At least 14 days following the 3rd vaccination|Per Protocol Population Using Per-Protocol Case Definition||Annual # of events per 1000 person-years|||Number
703135|NCT00090233|Primary|Occurrence of Rotavirus Disease Caused by Serotypes G1, G2, G3 and G4 That Occurs 14 Days Following the 3rd Vaccination|Rotavirus gastroenteritis cases consist of all participants with one or more episodes classified as positive. Multiple positive episodes for one participant are counted as a single case.|At least 14 days following the 3rd vaccination through the first full rotavirus season|Per Protocol Population Using Per-Protocol Case Definition||Participants|||Number
703136|NCT00090233|Secondary|G1 Serum Neutralizing Antibody (SNA) Responses Against Rotavirus|Number of participants with a 3-fold rise or greater in G1 Serum neutralizing antibody (SNA) responses against rotavirus from baseline to postdose 3.|14 days following the 3rd vaccination|Per Protocol Population among participants in Finland using Per-Protocol Case Definition||Participants|||Number
703137|NCT00090233|Primary|Intussusception Within 42 Days Following Any Dose of RotaTeq™/Placebo|Number of participants with confirmed intussusception within 42 days after each vaccination with RotaTeq™/placebo.|Within 42 days following any dose of RotaTeq™/placebo|All participants in the study were followed for potential cases of intussusception.||Participants|||Number
703138|NCT00090259|Secondary|Number of Participants That Experienced Cardiovascular Hospitalization||Entire follow-up (median = 4.7 years)|Intention-to-Treat||Participants|||Number
703139|NCT00090259|Secondary|Number of Participants That Were Hospitalized for Heart Failure||Entire follow-up (median = 4.7 years)|Intention-to-Treat||Participants|||Number
703140|NCT00090259|Secondary|Number of Participants That Died (Any Cause)||Entire follow-up (median = 4.7 years)|Intention-to-Treat||Participants|||Number
703141|NCT00090259|Secondary|Number of Participants That Experienced One Components of the Composite Clinical Endpoint of All Cause Death or Cardiovascular Hospitalization|Cardiovascular hospitalization is defined as any hospitalization that may be attributed to a cardiovascular cause, including heart failure.|Entire follow-up (median = 4.7 years)|Intention-to-Treat||Participants|||Number
703142|NCT00090259|Primary|Number of Participants That Experienced One Component of the Composite Clinical Endpoint of All Cause Death or Hospitalization for Heart Failure||Entire follow-up (median = 4.7 years)|Intention-to-Treat||Participants|||Number
703143|NCT00090285|Primary|Number of Participants With Vaccine-Related Serious Adverse Events (SAEs)||Base study: through Month 36|All participants receiving at least 1 vaccination with qHPV vaccine or placebo in the base study||participants|||Number
703144|NCT00090285|Primary|Number of Participants With Severe Injection Site Adverse Experiences (AEs)||Base study: through Day 5 after any vaccination|All participants receiving at least 1 vaccination with qHPV vaccine or placebo in the base study||participants|||Number
703145|NCT00090285|Other Pre-specified|Substudy to Evaluate the Incidence of HPV 6/11/16/18-related Anal Intraepithelial Neoplasia (AIN) and Anal Cancer in Men Having Sex With Men (MSM)|Participants with HPV 6/11/16/18-related AIN or anal cancer per 100 person-years of follow-up|Base study: through Month 36|Only a subset of the enrolled population was used for the analysis of this substudy. Per-protocol participants that were naïve to the relevant vaccine HPV types at enrollment and remained PCR negative to the relevant types through the vaccination period, including the Month 7 visit were analyzed.||Incidence per 100 person-years|||Number
703146|NCT00090285|Secondary|Incidence of HPV 6/11/16/18-related Deoxyribonucleic Acid (DNA) Detection|Subjects with HPV 6/11/16/18-related DNA detection per 100 person-years of follow-up.|Base study: through Month 36|"Per-protocol population: subjects must
have no major protocol violations, must be seronegative to the relevant HPV type at Day 1 and PCR negative to
the relevant HPV type Day 1 through Month 7, and must provide follow-up data after Month 7."||Detection per 100 person-years|||Number
703147|NCT00090285|Secondary|Incidence of HPV 6/11/16/18-related Persistent Infection|Subjects with HPV 6/11/16/18-related persistent infection per 100 person-years of follow-up.|Base study: through Month 36|Per-protocol population: subjects must have no major protocol violations, must be seronegative to the relevant HPV type at Day 1 and PCR negative to the relevant HPV type Day 1 through Month 7, and must provide follow-up data after Month 7.||Infection per 100 person-years|||Number
703148|NCT00090285|Primary|Incidence of Human Papillomavirus (HPV) Related External Genital Warts, Perineal Intraepithelial Neoplasia (PIN), Penile, Perianal or Perineal Cancer|Subjects with HPV 6/11/16/18-related external genital warts, PIN, penile, perianal or perineal cancer per 100 person-years of follow-up.|Base study: through Month 36|Per-protocol population: subjects must have no major protocol violations, must be seronegative to the relevant HPV type at Day 1 and polymerase chain reaction (PCR) negative to the relevant HPV type Day 1 through Month 7, and must provide follow-up data after Month 7.||Incidence per 100 person-years|||Number
703150|NCT00090363|Secondary|Objective Response Rate (ORR)|Using the Response Evaluation Criteria in Solid Tumours (RECIST), an objective response (OR) is defined as a patient having a best overall response of either complete response (CR) or partial response (PR), which is subsequently confirmed as per RECIST. Objective Response Rate (ORR) is defined as the percentage of patients with OR.|For patients with measurable disease at baseline, Response Evaluation Criteria in Solid Tumours (RECIST) scans were 12-weekly from randomisation. 'Initial analysis' results are given - the most recent formal analysis (data cut-off 10th April 2006).|Only patients with measurable disease at the baseline were included in the analysis.||percentage of participants|||Number
703151|NCT00090363|Secondary|Change in Total Prostate Specific Antigen (PSA) Over Time|Percentage change in total Prostate Specific Antigen (PSA) (ng/mL) from baseline to 12 weeks.|Baseline to 12 weeks. 'Initial analysis' results are given - the most recent formal analysis (data cut-off 10th April 2006).|The analysis population only includes patients with baseline and Week 12 PSA measurements||Percentage Change in PSA||Standard Deviation|Mean
703152|NCT00090363|Secondary|Time to Death|Median time (in days) from randomisation until death using the Kaplan-Meier method.|Follow-up for progression/death was 4-weekly for 2 years after first dose and 3-monthly thereafter. After progression survival was assessed 6-monthly. 'Final analysis' results are given - the most recent formal analysis (data cut-off 18th December 2008).|||Days||Inter-Quartile Range|Median
703153|NCT00090363|Primary|Time to Progression (TTP)|Median time (in days) from randomisation until disease progression, where progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline or death using the Kaplan-Meier method.|Follow-up for progression/death was 4-weekly for 2 years after first dose and 3-monthly thereafter. 'Final analysis' results are given - the most recent formal analysis (data cut-off 18th December 2008).|||Days||Inter-Quartile Range|Median
703154|NCT00090402|Secondary|Change in Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL) Scores From Baseline to 12 Months|The Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL) measures an individual's ability to carry out tasks that are important for daily living and capture functional changes. Scores for each question range from 0 (no assistance needed) to 2 (full assistance needed), and were assessed by informant interview. The combination of scores for ADL (ranging from 0-18) and IADL (0-14) is the outcome (0-32), with higher scores indicating lesser ability to carry out daily living tasks.|baseline, 12 months|In the placebo group there were 2 discontinuations (1 moved, 1 death). In the fish oil group there were 2 discontinuations (1 discontinue, 1 death). In the fish oil and lipoic acid group there was 1 discontinuation (due to meds). These discontinuations did not complete the study.||units on a scale||Standard Error|Mean
703155|NCT00090402|Primary|Change in Mini-Mental State Exam (MMSE) Score From Baseline to 12 Months|The MMSE is a measure of global cognitive function, and scores range from 0–30, with a lower score indicates greater cognitive impairment.|baseline, 12 months|||units on a scale||Standard Deviation|Mean
703156|NCT00090402|Primary|F2-isoprostane Level Urine F2-Isoprostanes|F2-isoprostane is a biomarker was used as an effective indicator for detecting a decrease in systemic oxidative damage (oxidative damage in lipids). Urine F2-Isoprostanes were used to avoid ex vivo lipid peroxidation that can occur with plasma samples.|baseline, 12 months|intention to treat (ITT)||nanogram per miligram||Standard Deviation|Mean
703157|NCT00090493|Primary|The Number of Participants Experiencing a Response to the Peptide Vaccines.|The peptides are fragments from two proteins MAGE-A3 and NY-ESO-1. There will be a series of 12 peptide vaccinations given as a subcutaneous (beneath the skin) injection (vaccines) at 2 week intervals resulting in an immune response to myeloma. The tumor peptides used in the vaccines are unique to myeloma, and it is not expected that there will be an immune response to normal organs. Myeloma cells must express MAGE-A3 or NY-ESO-1, be severe enough to require chemotherapy and stem cell transplantation and have appropriate HLA tissue type.|2 week intervals|only 2 were complete per protocol. 2 were withdrawn by physician due to relapse.||participants|||Number
703158|NCT00090519|Primary|Occurrence of Sustained Moderate Visual Loss (SMVL) in a Diabetic Retinopathy (DR) Study Eye|The occurrence of SMVL was defined as ≥15 letter decrease from baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) in any DR study eye relative to baseline that is sustained for the last 6 months of participation. ETDRS VA: participant starts at the top of the chart containing 5 letters per row and reads down the chart until reaching a row where a minimum of 3 letters on a line cannot be read. Participant is scored by how many letters could be correctly identified. A higher number of letters correctly identified represents better visual acuity.|Baseline, 36 Months|Intent-to-treat (ITT) population: all randomized participants with at least 1 eligible study eye analyzed according to the treatment group to which they were originally assigned by random allocation even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.||participants|||Number
703159|NCT00090519|Secondary|Number of Participants With Adverse Events|Summaries of serious adverse events (SAEs) and all other non-serious adverse events (AEs) are located in the Reported Adverse Event Module.|Baseline through 36 Months|Safety population: all randomized participants who received at least one dose of study drug.||participants|||Number
703160|NCT00090519|Secondary|Change From Baseline at Endpoint in Visual Function by the National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25) at 36 Months|25 vision-targeted questions representing 11 vision-related constructs and a 1-item general health rating question. Measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning and task-oriented domains related to daily visual functioning. Each item is converted to a 0 to 100 scale such that a higher score represents better functioning.|36 Months|Intent-to-treat (ITT) population including all randomized participants analyzed according to the treatment group to which they were originally assigned by random allocation even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.||units on a scale||Standard Deviation|Mean
703161|NCT00090519|Secondary|Change From Baseline at Endpoint in Albumin/Creatinine Ratio||36 Months|The completer population includes participants who completed all 36 months of the treatment phase.||micrograms/millimole (ug/mmol)||Standard Deviation|Mean
703206|NCT00081289|Secondary|Time to Treatment Failure and Patterns of Failure||From randomization to date of local failure, regional failure, distant failure, death or last follow-up. Analysis occurs after all patients have been potentially followed for 12 months.||||||
703162|NCT00090519|Secondary|Change From Baseline in Estimated Glomerular Filtration Rate|The Modification of Diet in Renal Disease (MDRD) study formula used for the estimated glomerular filtration rate (eGFR) determination is: eGFR = 170 X (Serum creatinine concentration [mg/deciliter (dL)])-0.999 X (Age [years]) -0.176 X (0.762 if participant is female) X (1.180 if participant is black) X (Serum urea nitrogen concentration [mg/dL])-0.170 X (Serum albumin concentration [grams (g)/dL])+0.318.|Baseline, 36 Months|Intent-to-treat (ITT) population including all randomized participants analyzed according to the treatment group to which they were originally assigned by random allocation even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.||milliliter/minute/1.73 square meter||Standard Deviation|Mean
703163|NCT00090519|Secondary|Progression of Nonproliferative Diabetic Retinopathy (DR) by Seven-field Stereo Fundus Photography|Participants were classified as having experienced progression or no progression of DR by 36-month visit. Progression of DR=3 steps on ETDRS retinopathy severity person scale for participants with both eyes less than proliferative diabetic retinopathy (PDR) at baseline OR 2 steps on ETDRS retinopathy severity eye scale for participants with 1 eye less than PDR at baseline OR application of panretinal laser therapy. Participants were assigned at baseline to ETDRS retinopathy severity scale for persons or individual eyes; determination of no progression/progression was dependent on the scale.|Baseline through 36 Months|Intent-to-treat (ITT) population including all randomized participants analyzed according to the treatment group to which they were originally assigned by random allocation even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.||participants|||Number
703164|NCT00090519|Secondary|Change From Baseline in Contrast Sensitivity by Pelli-Robson|Pelli-Robson chart read from left to right + from top to bottom. Each line has 2 groups, each of 3 letters. Letters in each group have same contrast. Contrast in each successive group is less than the preceding group. Participant reads letters starting with highest contrast, continues until 2 or 3 letters in 1 group are incorrectly named. Scored on key showing all letters at full contrast, gives the log contrast sensitivity corresponding to each group. Score is determined by previous group (last group in which 2 or 3 letters were correctly named). Results reported based on number of DR eyes.|Baseline, 36 Months|Intent-to-treat (ITT) population: all randomized participants analyzed according to treatment group to which they were originally assigned by random allocation even if they did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol.||Letters read correctly|Participants|Standard Deviation|Mean
703165|NCT00090519|Secondary|First Occurrence of Focal/Grid Photocoagulation|The first occurrence of focal/grid photocoagulation regardless of diabetic macular edema (DME) distance from the center of the macula.|Baseline through 36 Months|Intent-to-treat (ITT) population including all randomized participants analyzed according to the treatment group to which they were originally assigned by random allocation even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.||participants|||Number
703166|NCT00090519|Secondary|Change From Baseline in Visual Acuity by Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) Chart at 36 Months|ETDRS VA: participant starts at the top of the chart containing 5 letters per row and reads down the chart until reaching a row where a minimum of 3 letters on a line cannot be read. Participant is scored by how many letters could be correctly identified. A higher number of letters correctly identified represents better visual acuity. Results are reported based on the number of diabetic retinopathy (DR) eyes.|Baseline, 36 Months|Intent-to-treat (ITT) population including all randomized participants analyzed according to the treatment group to which they were originally assigned by random allocation even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.||Letters read correctly|Participants|Standard Deviation|Mean
703167|NCT00090519|Primary|Mean Duration of Definite Center of Macula-involved Diabetic Macular Edema (DME)|Duration of center of macula involvement when primary study outcome (DME involvement in center of macula determined by central grading of stereoscopic fundus photographs) was identified at a visit, participant was considered to have had definite center involvement for a specified length of time between the adjacent visits. Total duration of center involvement was calculated. Mean duration was total duration of center involvement divided by total number of participants. Participant durations were summarized, total number of months of center involvement in both treatment groups were displayed.|6 Months through 36 Months|Intent-to-treat (ITT) population including all randomized participants analyzed according to the treatment group to which they were originally assigned by random allocation even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.||months per participant||Standard Deviation|Mean
703168|NCT00090545|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events, see the adverse event module.|49 months|||participants|||Number
703169|NCT00090545|Primary|Progression Free Survival|Determine whether BAY 43-9006 when used to treat metastatic prostate cancer is associated with having 50% of Patients Progression Free at 4 Months by clinical, radiographic, and prostatic specific antigen (PSA)criteria.|4 months|||months||95% Confidence Interval|Median
703170|NCT00090584|Secondary|Symptom Improvement|"Number of women who responded much better or better to question: Overall, do you feel that you are much better, better, about the same, worse or much worse?"|8 months|Participants who completed the perceived improvement item at 8 months.||participants|||Number
703171|NCT00090584|Secondary|Symptom Improvement|"Number of women who responded much better or better to question: Overall, do you feel that you are much better, better, about the same, worse or much worse?"|10 weeks|Participants who completed the satisfaction item at 10 weeks.||participants|||Number
703172|NCT00090584|Secondary|Satisfaction|"Number of women who responded completely satisfied to question How satisfied are you with your progress?"|8 months|Number of participants who completed the 8 months satisfaction questions||participants|||Number
703173|NCT00090584|Secondary|Satisfaction|"Number of women who responded completely satisfied to question, How satisfied are you with your progress?"|10 weeks|Number of women who completed satisfaction question at 10 weeks.||participants|||Number
703174|NCT00090584|Secondary|Symptom Bother|Disease specific overactive bladder scale (OAB-q). HIgher score indicates greater bother. Possible range 0 to 100.|baseline, 10 weeks and 8 months|Participants who completed OAB-q assessment at each time in each treatment group.||units on a scale||Standard Deviation|Mean
703181|NCT00090610|Secondary|Quality of Life|"Quality of Life was measured using the Trial Outcome Index (TOI) score of the Functional Assessment of Cancer Therapy-Ovarian (FACT-O) instrument, version 4. The TOI portion of the FACT-O included questions related to Physical well-being (PWB), Social/Family well-being (FWB), and an ovarian cancer specific module (OCS). The PWB score range is from 0-28; the FWB score range is from 0-28; the OCS score range is from 0-44; this gives the TOI a score range from 0-100. (TOI = PWB + FWB + OCS)
With these instruments, a higher score indicates better health-related quality of life."|Baseline performed 14 days before first dose, then every other cycle and at study termination|The number of participants was based on QoL data available for Arm 1 and one patient withdrew on Arm 2.||units on a scale||Standard Deviation|Mean
703182|NCT00090610|Secondary|Objective Response Rate|"Complete response rate plus partial response rate, where: Complete response (CR) is defined as disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart and normalization of elevated CA125 in cases of ovarian cancer; Partial response (PR) for measurable disease is defined >= 30% decrease in the sum of the longest dimensions of all target measurable lesions with no unequivocal progression of non-target lesions as well as no new lesions, with documentation by two disease assessments at least four weeks apart. PR according to CA125 levels is defined as a 50% decrease in CA125 levels where two initial samples were elevated and the sample that shows the 50% is confirmed by a fourth sample 28 days after the prior sample.
OR = CR + PR"|Every 6 months, starting at 12 months to 24 months|Same as for PFS||percentage of participants||95% Confidence Interval|Number
703183|NCT00090610|Primary|Progression-free Survival (PFS)|"Progression in measurable disease is defined as any of the following: At least a 20% increase in the sum of the longest diameter target lesions; appearance of one or more new lesions; Death due to disease without prior objective documentation of progression; deterioration in health status attributable to the disease requiring a change in therapy without objective documentation of progression
Progression in non-measurable disease according to CA125 levels is defined as any of the following: CA125 that begins in normal range increases to twice the upper limit of normal; CA125 level that begins elevated increases 25% over two previous samples, a 50% increase over three previous samples, or a persistent elevation over 100 U/ml for more than 2 months without a 50% decrease."|Every 6 months, to 18 months|1 patient in each arm was excluded. The patient in Arm 1 did not complete 1 cycle of therapy. A patient in Arm 2 withdrew from the study||months||95% Confidence Interval|Median
703184|NCT00090753|Secondary|Percentage of Patients Who Had at Least 1 Adverse Event|See the adverse events section of the results for more information.|From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months)|Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.||Percentage of participants|||Number
703185|NCT00090753|Primary|Change From Baseline in Hemoglobin Concentration to the Last Month of Study Participation|Blood samples were collected at each study visit, that is, every 4 weeks for the first 12 weeks, every 12 weeks until week 105 of the first study period, every 3 months thereafter, and at the end of study or the last visit if the patient discontinued the study prematurely.|Baseline to the end of the study (Up to 49 Months)|Analysis includes participants from the Intent-to-treat population (all patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA) who had hemoglobin values available for analysis.||g/dL||Standard Deviation|Mean
703186|NCT00081159|Other Pre-specified|Overall Survival (OS)|Overall Survival defined as the length of time from the start of treatment till time that participants are still alive.|Up to 90 months|Intent to treat population analysis.||Months||95% Confidence Interval|Median
703187|NCT00081159|Secondary|Major Bone Scan Response|Bone scan performed at baseline and at Week 13 provided if baseline scan was positive for metastases. A major bone scan response was considered with a substantial resolution of participant bone metastases on the bone scans, i.e. complete resolution of the osseous metastases on the bone scan.|Week 13|Five participants in the non-Strontium arm were not evaluable for this outcome, four withdrew prior to treatment, and one had disease progression that precluded inclusion. Two participants in the Strontium arm were lost to follow up therefore excluded from analysis as well.||participants|||Number
703188|NCT00081159|Primary|Progression Free Survival (PFS)|Study’s primary endpoint of PFS duration/time to progression was defined as the time from the date of randomization to the date of first evidence of disease progression or patient death. Prostate-specific antigen (PSA) progression is usually the first evidence of progression. PSA progression is defined as a 25% increase over the baseline or the nadir provided that the increase is a minimum of 1 ng/ml.|Up to 90 months with evaulation in 4 week intervals for up to 6 months of treatment, then follow up until disease progression|Intent to treat population analysis.||Months||95% Confidence Interval|Median
703189|NCT00081263|Other Pre-specified|To Examine the Association of Histologic Response in Angiogenisis (VEGF)||Up to 18 weeks||||||
703190|NCT00081263|Other Pre-specified|To Examine the Association of Histologic Response in Apoptosis Index (TUNEL Assay)||Up to 18 weeks||01/2099||||
703191|NCT00081263|Other Pre-specified|The Number of Quadrants Involving CIN||Up to 18 weeks||||||
703192|NCT00081263|Other Pre-specified|Proportion of Patients Whose Eligibility Can be Successfully Determined Using the Web-based Review||Baseline||||||
703193|NCT00081263|Other Pre-specified|To Examine the Association of Histologic Response in Proliferation Index (Ki67).||Up to 18 weeks||||||
703194|NCT00081263|Other Pre-specified|To Determine the Feasibility of Digital Imaging Using Pathologist’s Diagnosis and Diagnostic Technique (Web-based or Standard Method).||Baseline||||||
703195|NCT00081263|Other Pre-specified|Levels of Serum VEGF||Up to 18 weeks||||||
703196|NCT00081263|Other Pre-specified|Levels of Serum bFGF||Up to 18 weeks||||||
703197|NCT00081263|Other Pre-specified|To Examine the Association of Histologic Response in the Levels of Celecoxib in Serum During Treatment.||Up to 18 weeks||||||
703198|NCT00081263|Other Pre-specified|HPV Viral Load Before and After Treatment||Up to 18 weeks||||||
703199|NCT00081263|Other Pre-specified|To Examine the Association of Histologic Response in HPV Viral Load in Serum Before and After Treatment||Up to 18 weeks||||||
703200|NCT00081263|Other Pre-specified|To Examine the Association of Histologic Response in COX-2 in Tissue||Up to 18 weeks||||||
703678|NCT00095498|Secondary|Change From Baseline in Basophils at Month 3|Laboratory hematology basophils|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.||* 10^9/L||Standard Deviation|Mean
703207|NCT00081289|Primary|Pathologic Complete Response Rate|"A pathologic complete response (pCR) was defined as no evidence of residual cancer histologically; disease progression or death before surgery was considered less than pCR (even without surgical specimen). All cases were reviewed by the study’s surgical oncology co-chair for the determination of pCR.
Each arm was first analyzed alone. If the arm had 9 or more pCRs in 48 evaluable pts, then the null hypothesis (H0) of 10% pCR rate would be rejected in favor of the alternative hypothesis of 25%, providing 90% power with a two-sided 10% type I error rate. If both arms reject H0, then statistical selection theory would be used to choose the arm for further study in a phase III trial. If only one arm has acceptable pCR rate, then that arm would be pursued in a phase III trial."|After protocol surgery|For each arm the first 48 eligible enrolled after the protocol amendment.||percentage of participants||95% Confidence Interval|Number
703208|NCT00081328|Secondary|Comorbidity -- Triglycerides Dyslipidemia|A diagnosis was made by an out-of-range value >=150 mg/dL sustained over 6 months or on appropriate lipid lowering medication.|Data collected at baseline and during follow-up - 2 years to 6.5 years from randomization.|Entire cohort.||participants|||Number
703209|NCT00081328|Secondary|Comorbidity -- LDL Dyslipidemia|A diagnosis was made from out-of-range value >= 130 mg/dL sustained over 6 months or put on lipid lowering medication.|Data collected at baseline and during follow-up - 2 years to 6.5 years from randomization.|Entire cohort.||participants|||Number
703210|NCT00081328|Secondary|Comorbidity -- Hypertension|A diagnosis was made by an out-of-range value >=95th percentile or systolic >=130 or diastolic >=80 sustained over 6 months or on an anti-hypertensive medication.|Data collected at baseline and during follow-up - 2 years to 6.5 years from randomization.|Entire cohort.||participants|||Number
703211|NCT00081328|Secondary|Body Composition -- Fat Mass|Determined by DXA whole body scan. The analysis sample includes only participants with 24 month data who had not experienced the primary outcome by that time. In addition, in about 1/3 of participants DXA scans could not be obtained on participants weighing more than 300 pounds (136 kg), the upper limit in size set by the machine manufacturers. Scans were considered invalid if a body part (e.g., arm, leg) was completely off or partially off the scanner, there was hand-hip overlap, or there was motion or movement during the scan.|24 months|Members of the cohort measured at 24 months who did not experience treatment failure.||kg||Standard Deviation|Mean
703212|NCT00081328|Secondary|Body Composition -- Bone Density|Measured by DXA, both whole body scan and AP-spine scan. The analysis sample includes only participants with 24 month data who had not experienced the primary outcome by that time. In addition, in about 1/3 of participants DXA scans could not be obtained on participants weighing more than 300 pounds (136 kg), the upper limit in size set by the machine manufacturers. Scans were considered invalid if a body part (e.g., arm, leg) was completely off or partially off the scanner, there was hand-hip overlap, or there was motion or movement during the scan.|24 months|Members of the cohort measured at 24 months who did not experience treatment failure.||g/cm squared||Standard Deviation|Mean
703213|NCT00081328|Secondary|Body Composition -- Waist Circumference|Waist circumference (cm) measured at the iliac crest at its outermost point with the measuring tape placed around the participant in a horizontal plane parallel to the floor at the mark and the measurement teken at the end of normal expiration without the tape compressing the skin. The analysis sample includes only participants with 24 month data who had not experienced the primary outcome by that time.|24 months|Members of cohort measured at 24 months who had not experience treatment failure.||cm||Standard Deviation|Mean
703214|NCT00081328|Secondary|Body Composition -- BMI|Body mass index (BMI) measured in kg per meters squared. The analysis sample includes only participants with 24 month data who had not experienced the primary outcome by that time.|24 months|Cohort measured at 24 months and had not experienced treatment failure.||kg per meters squared||Standard Deviation|Mean
703215|NCT00081328|Secondary|Insulin Secretion|Insulinogenic index determined from OGTT as difference in insulin at 30 minutes minus 0 minutes divided by difference in glucose at 30 minutes minus 0 minutes. The analysis sample includes only participants with 24 month data who had not experienced the primary outcome by that time.|24 months|Participants who were measured at 24 months and had not experience treatment failure.||uU/mL divided by mg/dL||Inter-Quartile Range|Median
703216|NCT00081328|Secondary|Safety|Number of serious adverse events reported during the trial. Participant could have multiple episodes reported.|Reported as occurred during study follow-up - 2 years to 6.5 years from randomization.|Entire cohort.||episodes of serious adverse event|||Number
703217|NCT00081328|Secondary|Insulin Sensitivity|All participants were followed to 24 months. Insulin sensitivity is measured from OGTT as inverse of fasting insulin (mL/uU). The analysis sample includes only participants with 24 month data who had not experienced the primary outcome by that time.|24 months|Participants who were measured at 24 months and had not experienced treatment failure.||mL/uU||Inter-Quartile Range|Median
703218|NCT00081328|Primary|Treatment Failure (Loss of Glycemic Control)|Defined as A1c persistently >=8% over a 6-month period or persistent metabolic decompensation (inability to wean insulin within 3 months of initiation or the occurrence of a second episode within three months of discontinuing insulin)|Study duration - 2 years to 6.5 years of follow up from randomization|The entire cohort of 699 participants was included in the analysis.||participants|||Number
703219|NCT00081458|Secondary|Number of Subjects Achieving Binary Response at Week 20, Maintained at Week 24|An efficacy responder was defined as achieving at least a 20% reduction from Baseline to Week 20 and maintained at Week 24 in weekly actual PN infusion volume.|6 months of treatment|||participants|||Number
703220|NCT00081458|Primary|A Graded Response Score in Parenteral Nutrition (PN) Reduction|"The intensity of the response relied on a reduction from Baseline in weekly parenteral nutrition (PN) volume (minimum reduction of 20% and a maximum of 100%). Duration of the response incorporated responses at Weeks(Wk) 16-20 and at Wk20-24.
Zero (0 - lowest) assigned if <20% reduction at Wk20-24 and reduction at Wk16-20 of < 20%, 20-39%, or >=40%.
One (1) assigned if reduction of 20-39% at Wk20-24 but < 20% at Wk16-20. Two(2) assigned if reductions of 40-99% at Wk20-24 AND <20% at Wk16-20 OR 20-39% at Wk20-24 AND 20-39% at Wk16-20.
Three (3) assigned if reductions of 100% at Wk20-24 AND <20% at Wk16-20 OR 40-99% at Wk20-24 AND 20-39% at Wk16-20 OR 20-39% at Wk20-24 AND >=40% at Wk16-20.
Four (4) assigned if reductions of 100% at Wk20-24 AND 20-39% at Wk16-20 OR 40-99% at Wk20-24 AND >=40% at Wk16-20."|6 months|Intent to Treat (ITT) analysis using a stepdown procedure that was stopped if the 0.10 mg/kg dose was not significantly better than placebo.||participants|||Number
703221|NCT00090766|Secondary|Number of Participants Who Experienced Episodes of Rejection Over Time|Participants with biopsy proven active rejection are reported.|Up to Week 26|The ITT population comprised all participants who received at least one dose of the study drug, whether on-study or prematurely withdrawn.||participants|||Number
703222|NCT00090766|Secondary|Mean Elimination Half-Life of Valganciclovir Over Time|The Elimination Half-Life Period is defined as the time measured for the plasma concentration to decrease by half to its original concentration. One participant was not analyzed for this outcome measure as the participant underwent both a kidney and liver transplant. Here n represents number of participant with specific transplant i.e., kidney, liver, and heart.|Pre-dose; 1-3, 3-7, 7-12 hours post dose on any day between Day 7 to Day 14; Week 6, Week 10, and Week 14|The PK analysis population comprised all participants from studies WP16296, WP16303 and WV16726 who completed the specified treatment and from whom at least one plasma sample was taken.||hours||Standard Deviation|Mean
703223|NCT00090766|Secondary|Mean Maximum Plasma Concentration of Valganciclovir Over Time|Maximum Plasma Concentration (Cmax) is defined as the maximum observed plasma concentration of Valganciclovir. Participants with kidney, liver and heart transplant were analyzed. One participant was not analyzed for this outcome measure as the participant underwent both a kidney and liver transplant.|Pre-dose; 1-3, 3-7, 7-12 hours post dose on any day between Day (D) 7 to D 14; and at Week (W) 6, W 10, and W 14|The PK analysis population comprised all participants from studies WP16296, WP16303 and WV16726 who completed the specified treatment and from whom at least one plasma sample was taken. Here n represents number of participant with specific transplant i.e., kidney, liver, and heart.||mcg/mL||Standard Deviation|Mean
703224|NCT00090766|Secondary|Number of Participants Who Experienced Graft Loss|Graft loss was defined as impairment of organ function to such a degree that the participant died or underwent re-transplantation.|Up to Week 26|ITT population: The ITT population comprised all participants who received at least one dose of the study drug, whether on-study or prematurely withdrawn.||participants|||Number
703225|NCT00090766|Secondary|Number of Participants With Treatment Failures|Treatment failure was defined as either the development of CMV (viremia, antigenemia or test positive) requiring treatment up to day 100 post-transplant (i.e, while undergoing prophylaxis with valganciclovir up to day 100) or discontinuation of study medication due to lack of efficacy or to toxicity.|Up to Week 26|The Intent to Treat (ITT) population comprised all participants who received at least one dose of the study drug, whether on-study or prematurely withdrawn.||participants|||Number
703226|NCT00090766|Secondary|Number of Participants With Cytomegalovirus Disease Over Time|Cytomegalovirus (CMV) disease is defined as syndrome or tissue invasive disease in which CMV virus was identified in blood, urine, biopsy or other suitable specimen, which could be in conjunction with one or more of the following events: a) CMV syndrome was defined as virus present in blood or other suitable specimen, plus fever, and any of the following: leukopenia, atypical lymphocytosis, thrombopenia or elevated hepatic transaminases (for non-liver recipients). b) The diagnosis of organ specific tissue invasive CMV disease was evidence of CMV in the tissue (CMV inclusion bodies or in situ detection of CMV antigen or DNA), plus signs/symptoms of organ dysfunction.|Up to Week 26|Safety population included all participants who received at least one dose of valganciclovir.||participants|||Number
703227|NCT00090766|Primary|Number of Participants With 4 Grade Shift From Baseline of Adverse Events in Hematology and Serum Chemistry|The number of participants experiencing a 4 grade shift (example from Grade 0 to Grade 4) from BL in hematology and serum chemistry laboratory parameters are reported. The data was analyzed for overall study only.|Up to Week 26|Safety population included all participants who received at least one dose of valganciclovir.||participants|||Number
703228|NCT00090766|Primary|Number of Participants With 3 Grade Shift From Baseline of Adverse Events in Hematology and Serum Chemistry|The number of participants experiencing a 3 grade shift (example from Grade 0 to Grade 3) from baseline (BL) in hematology and serum chemistry laboratory parameters are reported. The data was analyzed for overall study only.|Up to Week 26|Safety population included all participants who received at least one dose of valganciclovir.||participants|||Number
703229|NCT00090766|Primary|Number of Participants With Adverse Events Leading to Discontinuation of the Study Drug|An AE was defined as any untoward medical occurrence in a clinical investigation in participant administered a pharmaceutical product, which did not necessarily have to have a causal relationship with this treatment. The number of participants with AEs leading to discontinuation of the study drug is reported.|Up to Week 26|Safety population included all participants who received at least one dose of valganciclovir.||participants|||Number
703230|NCT00090766|Primary|Number of Participants With Any Adverse Events and Any Serious Adverse Events|An AE was defined as any untoward medical occurrence in a clinical investigation in participant administered a pharmaceutical product, which did not necessarily have to have a causal relationship with this treatment. A serious adverse event (SAE) is any experience or a significant hazard, that is fatal, life-threatening, requires in-patient hospitalization or prolongation of existing one, results in persistent or significant disability, is a congenital anomaly, is medically significant or requires intervention to prevent one or other of the outcomes listed above.|Up to Week 26|Safety population included all participants who received at least one dose of valganciclovir.||participants|||Number
703231|NCT00090766|Primary|Number of Participants With Opportunistic Infections|Opportunistic infections included oral candidiasis, candidiasis, herpes simplex, cytomegalovirus antigen positive, cytomegalovirus test positive. The number of participants with opportunistic infections are reported.|Up to Week 26|Safety population included all participants who received at least one dose of valganciclovir.||participants|||Number
703232|NCT00090766|Primary|Number of Participants With Adverse Events Leading to Dose Interruption or Modification|An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation in participant administered a pharmaceutical product, which did not necessarily have to have a causal relationship with this treatment. The number of participants with AEs leading to dose interruptions or modifications are reported.|Up to Week 26|Safety population included all participants who received at least one dose of valganciclovir.||participants|||Number
703243|NCT00090844|Secondary|Disease-free Survival Every Very 6 Months Beginning in Month 6 for 2 Years and Then Annually for 3 Years|Every 6 months for 2 years then annual for 3 more years. Patients will be seen, laboratory specimens will be drawn. Menses records will be collected and reviewed. Concomitant medications will be updated.|5 years after end of chemotherapy||||||
703233|NCT00090766|Primary|Mean Area Under the Concentration-Time Curve From 0 to 24 Hours of Valganciclovir|Area Under the Plasma Concentration-Time Curve (AUC) is a measure of the plasma concentration of the drug over time. The AUC 0-24 hours is area under the plasma concentration-time curve from time zero through 24 hours after dosing. A compartmental model was used to measure the plasma concentrations of valganciclovir. One participant was not analyzed for this outcome measure as the participant underwent both a kidney and liver transplant.|Pre-dose; 1-3, 3-7, 7-12 hours post dose on any day between Day 7 to Day 14; Week 6, Week 10, and Week 14|Pharmacokinetic (PK) population comprised of all participants from studies WP16296, WP16303 and WV16726 who had completed the specified treatment and from whom at least one plasma sample was taken. Here n represents number of participant with specific transplant i.e., kidney, liver, and heart.||mcg*hr/mL||Standard Deviation|Mean
703234|NCT00090779|Secondary|Time to Treatment Initiation or Death|5th, 10th, 25th, 50th and 75th percentiles in weeks from randomization to treatment initiation or death|5 years since randomization|All eligible subjects were included except one subject in IT arm with baseline multidrug resistance.||weeks||95% Confidence Interval|Number
703235|NCT00090779|Secondary|Time From Study Entry in DT Arm Participants or From Week 36 in IT Arm Participants to Meeting the Clinical, Virologic, or Immunologic Criteria for Treatment Initiation or Re-initiation|5th, 10th, 25th, 50th, 75th and 90th percentiles in weeks from randomization for DT arm or from week 36 for IT arm to meeting the criteria for treatment initiation or re-initiation which include two consecutive CD4 count below 350 cells/mm^3 at least 4 weeks apart, at least 12 weeks into the study or 12 weeks post-treatment discontinuation, confirmed CD4 count below 200 cells/mm^3 or CD4 percent below 14% at any time on study, confirmed HIV-1 RNA level above 750,000 copies/mL 4 weeks into the study or above 200,000 copies/mL 12 weeks or more into the study, or CDC Category B or C diagnosis.|96 weeks since randomization|Through database cutoff for DSMB review (by July 2, 2009). The analysis includes only those in the IT arm who continued ART through week 36 (n=49), compared to all in the DT arm (n=64).||weeks||95% Confidence Interval|Number
703236|NCT00090779|Secondary|Time to Meeting the Clinical, Virologic, or Immunologic Criteria for Treatment Initiation or Re-initiation|5th, 10th, 25th, 50th, 75th and 90th percentiles in weeks from randomization to meeting the criteria for treatment initiation or re-initiation which include CD4 count below 350 cells/mm^3 on two consecutive measurements at least 4 weeks apart, at least 12 weeks into the study or 12 weeks post-treatment discontinuation, confirmed CD4 count below 200 cells/mm^3 or CD4 percent below 14% at any time on study, confirmed HIV-1 RNA level above 750,000 copies/mL 4 weeks into the study or above 200,000 copies/mL 12 weeks or more into the study, or CDC Category B or C diagnosis.|96 weeks since randomization|Throughout database cutoff for DSMB review (by July 2, 2009).||weeks||95% Confidence Interval|Number
703237|NCT00090779|Secondary|Number of Participants in IT Arm Off Treatment Before 36 Weeks|The study provided fixed-dose combination emtricitabine/tenofovir DF 200/300 mg orally once daily and lopinavir/ritonavir 200/50 mg administered either as two tablets twice daily or four tablets once daily, for the first 36 weeks for individuals in the IT arm.|At Week 36|All 66 eligible subjects in IT arm were included.||participants|||Number
703238|NCT00090779|Secondary|Number of Participants Meeting Clinical, Virologic, or Immunologic Criteria for Treatment Initiation or Re-initiation|The clinical, virologic, or immunologic criteria for treatment initiation or re-initiation include CD4 count below 350 cells/mm^3 on two consecutive determinations at least 4 weeks apart, at least 12 weeks into the study or 12 weeks post-treatment discontinuation, (2) confirmed CD4 count below 200 cells/mm^3 or CD4 percent below 14% at any time on study, (3) confirmed HIV-1 RNA level above 750,000 copies/mL 4 weeks into the study or above 200,000 copies/mL 12 weeks or more into the study, or (4) CDC Category B or C diagnosis.|96 weeks since randomization|All 130 eligible subjects were included.||Participants|||Number
703239|NCT00090779|Secondary|Change in CD4 Counts Cells/mm^3 From Week 36 for IT Arm and From Week 0 for DT Arm||IT arm (weeks 36, 60, 72, 84 and 96) and DT arm (weeks 0, 24, 36, 48 and 60)|One subject in IT arm with multidrug resistance at baseline was excluded from this analysis.||Change in Log10 transformed CD4 Counts||Standard Deviation|Mean
703240|NCT00090779|Primary|Number of Participants Experiencing Either a CDC Category B or C Diagnosis, CD4<200 Cells/mm^3 or CD4 Percent <14%.||96 weeks since randomization|||participants|||Number
703241|NCT00090779|Primary|Ranked log10 HIV-1 RNA Viral Load (log10 Copies/mL) Averaged at Weeks 72 and 76 for the IT Arm and Ranked log10 HIV-1 RNA Viral Load (log10 Copies/mL) Averaged at Weeks 36 and 40 for the DT Arm|The primary endpoint is (i) average wk 36 and 40 VL for those who continued to wk 36 off ARV for the DT arm, (ii) average wk 72 and 76 VL for those who continued to wk 36 off ARV for the IT arm and (iii) an assigned VL rank for the “failures” who needed ARVs or met criteria for entry into Step 2 prior to these study visits. The assigned rank for the failures was either the last observed rank carried forward or the worst rank relative to the other possible outcomes. This approach was designed to, if anything, bias against finding a treatment effect. To illustrate, consider five participants who enter the study (A, B, C, D, and E), 4 of whom (A, B, C, D) make it to 72 wks off therapy with RNA levels that increase from A to D. Participant E enters Step 2 at wk 12, at which time his RNA is in the 50th percentile. This rank would be carried forward, so the rank order of the log10 HIV-1 RNA endpoints would be A B E C D.|IT arm (weeks 72 and 76) and DT arm ( weeks 36 and 40)|Participants in follow-up at least 72 weeks since randomization were included.||rank||Full Range|Median
703242|NCT00090779|Primary|Ranked Log10 HIV-1 RNA Viral Load (log10 Copies/mL) Averaged at 72 and 76 Weeks for the IT Arm and DT Arm|The primary endpoint is (i) the average of log10 viral loads (VL) at wks 72 and 76 for participants who continued to wk 72 off ARV for the DT arm, (ii) average wk 72 and 76 VL for those who continued to wk 36 off ARV for the IT arm and (iii) an assigned VL rank for the “failures” who needed ARVs or met criteria for entry into Step 2 prior to these study visits. The assigned rank for the failures was either the last observed rank carried forward or the worst rank relative to the other possible outcomes. This approach was designed to, if anything, bias against finding a treatment effect. To illustrate, consider five participants who enter the study (A, B, C, D, and E), 4 of whom (A, B, C, D) make it to 72 wks off therapy with RNA levels that increase from A to D. Participant E enters Step 2 at wk 12, at which time his RNA is in the 50th percentile. This rank would be carried forward, so the rank order of the log10 HIV-1 RNA endpoints would be A B E C D.|At Weeks 72 and 76|Participants in follow-up at least 72 weeks since randomization were included.||rank||Full Range|Median
707358|NCT00122369|Primary|Pain Ratings at Specified Time Point During the Procedure|Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain|20 min|Patients remaining on procedure table||units on a scale||Inter-Quartile Range|Median
703244|NCT00090844|Secondary|Quality of Life as Assessed by FACT-ES Monthly During Treatment, Every Very 6 Months Beginning in Month 6 for 2 Years and Then Annually for 3 Years|FACT-ES (v4/4a) quality of life validated tool combines 18 item endocrine subscale (ES) with standardized breast cancer quality of life measure. Administered monthly during treatment, every very 6 months beginning in month 6 for 2 years and then annually for 3 years.|Baseline, through chemotherapy then 5 years||||||
703245|NCT00090844|Secondary|Alternative Markers of Ovarian Failure as Assessed by Inhibin A and Inhibin B Every 6 Months Beginning in Month 6 for 2 Years and Then Annually for 3 Years|Inhibin A & inhibin B are collected at baseline, end of chemotherapy, then every 6 months for 2 years then annually for 3 more years. Inhibin A & Inhibin B are markers of ovarian failure.|Baseline, end of chemotherapy then 5 years||||||
703246|NCT00090844|Secondary|Chemotherapy-related Amenorrhea|Chemotherapy-related amenorrhea as assessed by record of menses monthly during treatment. Record of menses is completed by patient throughout their time on study through chemotherapy and for 5 years.|Baseline, end of chemotherapy then 5 years||||||
703247|NCT00090844|Primary|Time to Resumption of Menses|Ovarian function as assessed by follicle stimulating hormone (FSH) and record of menses every 6 months beginning in month 6 for 2 years and then annually for 3 years|Baseline, end of chemotherapy then 5 years|||months||Full Range|Median
703248|NCT00090857|Secondary|Worst Grade Fatigue|Participants reported worst grade fatigue: 01: mild, 02: moderate, 03: severe (CTCAEv3), 04: disabling (CTCAEv3) during 12 months of treatment.|Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months.|||Participants|||Count of Participants
703249|NCT00090857|Secondary|Worst Grade Headache|Participants reported worst grade headache: 01: mild, 02: moderate, 03: severe (CTCAEv3), 04: disabling (CTCAEv3) during 12 months of treatment.|Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months.|||Participants|||Count of Participants
703250|NCT00090857|Secondary|Worst Grade Bone Pain|Participants reported worst grade bone pain: 01: mild, 02: moderate, 03: severe (CTCAEv3), 04: disabling (CTCAEv3) during 12 months of treatment.|Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months.|||Participants|||Count of Participants
703251|NCT00090857|Secondary|Worst Grade Abdominal Pain|Participants reported worst grade abdominal pain: 01: mild, 02: moderate, 03: severe (CTCAEv3), 04: disabling (CTCAEv3) during 12 months of treatment.|Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months.|The analysis dataset is comprised of all randomized participants.||Participants|||Count of Participants
703252|NCT00090857|Secondary|Worst Grade Vomiting|Participants reported worst grade vomiting grade 01: 1x in 24 hours, 02: 2-5x in 24 hours, 03: >/= 6x in 24 hours, grade 04: requiring parenteral nutrition/intensive care during 12 months of treatment.|Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months.|The analysis dataset is comprised of all randomized participants.||Participants|||Count of Participants
703253|NCT00090857|Secondary|Worst Grade Nausea|Participants reported worst grade nausea grade 01: able to eat, 02: oral intake significantly decreased, 03: no significant intake, requiring IV fluids during 12 months of treatment.|Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months.|The analysis dataset is comprised of all randomized participants.||Participants|||Count of Participants
703254|NCT00090857|Secondary|Worst Grade Muscle Aches/Pains|Participants reported worst grade muscle aches/pains defined as grade 01: mild, 02: moderate, 03: severe (CTCAEv3) or 04: disabling (CTCAEv3) during 12 months of treatment.|Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months.|||Participants|||Count of Participants
703255|NCT00090857|Secondary|Worst Grade Hot Flashes|Participants reported worst grade hot flashes: 01: mild (<1qd) or 02: moderate (>1qd) during 12 months of treatment.|Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months.|The analysis dataset is comprised of all randomized participants.||Participants|||Count of Participants
703256|NCT00090857|Primary|Change in Hip Density From Baseline to 12 Months|The bone mineral density (BMD) test was comprised of the following 4 measurements [total density (g/cm^2)]: lumbar, femoral neck, trochanter, hip.|Evaluation occurred at treatment initiation (BL) and after 12-months of treatment.|The analysis dataset is comprised of randomized patients with an evaluable sample for analysis of hip density.||g/cm^2||Full Range|Median
703257|NCT00090857|Primary|Change in Trochanter Density From Baseline to 12 Months|The bone mineral density (BMD) test was comprised of the following 4 measurements [total density (g/cm^2)]: lumbar, femoral neck, trochanter, hip.|Evaluation occurred at treatment initiation (BL) and after 12-months of treatment.|The analysis dataset is comprised of randomized patients with an evaluable sample for analysis of trochanter density.||g/cm^2||Full Range|Median
703258|NCT00090857|Primary|Change in Femoral Neck Density From Baseline to 12 Months|The bone mineral density (BMD) test was comprised of the following 4 measurements [total density (g/cm^2)]: lumbar, femoral neck, trochanter, hip.|Evaluation occurred at treatment initiation (BL) and after 12-months of treatment.|The analysis dataset is comprised of randomized patients with an evaluable sample for analysis of femoral neck density.||g/cm^2||Full Range|Median
703259|NCT00090857|Primary|Change in Lumbar Density From Baseline to 12 Months|The bone mineral density (BMD) test was comprised of the following 4 measurements [total density (g/cm^2)]: lumbar, femoral neck, trochanter, hip.|Evaluation occurred at treatment initiation (BL) and after 12-months of treatment.|The analysis dataset is comprised of randomized patients with an evaluable sample for analysis of lumbar density.||g/cm^2||Full Range|Median
703260|NCT00090987|Secondary|Viral Transcription Profile of Kaposi's Sarcoma-associated Herpesvirus||12 months||||||
703261|NCT00090987|Secondary|Mechanisms of Primary and Secondary Resistance to Imatinib Therapy|Mutations in the juxtamembrane or kinase membrane of the c-kit or PDGF receptors at baseline or time of progression|12 months||||||
703262|NCT00090987|Secondary|Pharmacokinetic Profile of Imatinib and Antiretrovirals||12 months||||||
703263|NCT00090987|Secondary|Cytokine Profiles Before and After Imatinib Therapy||12 months||||||
703264|NCT00090987|Secondary|Inhibition of Platelet-derived Growth Factor-receptor as Assessed by Immunohistochemistry||12 months||||||
703265|NCT00090987|Primary|Proportion of Patients Who Achieve a Clinical Response|Clinical response = Complete Response (absence of residual disease) or Partial Response defined as no new lesions (skin or oral), or no new visceral sites of involvement (or the appearance or worsening of tumor-associated edema or effusions); AND 50% or greater decrease in the number of lesions lasting for >4 weeks; OR Complete flattening of at least 50% of all previously raised lesions OR A 50% decrease in the sum of the products of the largest perpendicular diameters of the marker lesions|20-24 weeks|||proportion|||Number
703266|NCT00091026|Secondary|Overall Survival|Time from randomization until death from any cause. Analyzed using the Kaplan-Meier (1958) estimator and their associated 5% confidence intervals determined using the method described in Brookmeyer and Crowley.|36 months|||Months||95% Confidence Interval|Median
703267|NCT00091026|Secondary|Progression-free Survival|Median progression-free survival time (time from randomization to disease progression or death from any cause). Analyzed using the Kaplan-Meier (1958) estimator and their associated 95% confidence intervals determined using the method described in Brookmeyer and Crowley.|36 months|||months||95% Confidence Interval|Median
703268|NCT00091026|Primary|Objective Response Rate (Complete or Partial Response) Evaluated Using the Response Evaluation Criteria in Solid Tumors (RECIST)||Up to 6 months|||percentage of participants||95% Confidence Interval|Number
703269|NCT00091169|Secondary|Proportion of Patients With Stable or Improving Performance Status at 4 Weeks|Performance status (PS) was measured using Eastern Cooperative Oncology Group performance status scale. Lower score represents better PS. Change in PS was calculated by PS at week 4- PS at baseline. Patients with negative value for change in PS were considered to have stable or improving PS.|assessed at baseline and 4 weeks after randomization|All randomized patients who had performance status data at baseline and 4 weeks||proportion of participants||95% Confidence Interval|Number
703270|NCT00091169|Secondary|Prevalence of Carnitine Deficiency at 4 Weeks|Carnitine deficiency is defined as a ratio of acylcarnitine (total-free) to free carnitine > 0.4 μmol/L or free carnitine < 35 μmol/L for males and < 25 μmol/L for females.|assessed at 4 weeks after randomization|All randomized patients who had carnitine data at 4 weeks||proportion of participants||95% Confidence Interval|Number
703271|NCT00091169|Secondary|Mean Score Change in Pain Measured With Brief Pain Inventory From Baseline to 4 Weeks|Pain was measured using Brief Pain Inventory (BPI). The mean of the 4 severity items (range: 0-10 with 0 representing no pain and 10 representing pain as bad as you can imagine) was used to measure pain severity. Score change= BPI score at 4 weeks - BPI score at baseline.|assessed at baseline and 4 weeks after randomization|All randomized patients who reported BPI score at both baseline and 4 weeks||units on a scale||95% Confidence Interval|Mean
703272|NCT00091169|Secondary|Mean Score Change in Depression Measured With CES-D Between 4 Weeks and Baseline|Depression was measured using Center for Epidemiologic Studies Depression Scale (CES-D). The sum of the scores for all 20 items (range: 0-60) was used to assess depression level, and higher scores indicated a higher level of depression. Score change= CES-D score at 4 weeks - CES-D score at baseline.|assessed at baseline and 4 weeks after randomization|All randomized patients who reported CES-D score at both baseline and 4 weeks||units on a scale||95% Confidence Interval|Mean
703273|NCT00091169|Secondary|Mean Score Change in Fatigue Measured With FACIT-F From Baseline to 4 Weeks|Fatigue was measured using Functional Assessment of Cancer Therapy- Fatigue subscale (FACIT-F). The sum of the scores for all 13 items (range: 0-52) included in the scale was used to measure fatigue level, and lower score represented worse fatigue. Score change= FACIT-F score at 4 weeks - FACIT-F score at baseline.|assessed at baseline and 4 weeks after randomization|All randomized patients who reported FACIT-F score at both baseline and 4 weeks||units on a scale||95% Confidence Interval|Mean
703274|NCT00091169|Primary|Mean Score Change in Fatigue Measured With Brief Fatigue Inventory From Baseline to 4 Weeks|Fatigue was measured using Brief Fatigue Inventory (BFI). The average of all 9 items included in the scale (range: 0-10) was used to measure fatigue level, and a higher average represented worse fatigue. Score change= BFI score at 4 weeks - BFI score at baseline.|assessed at baseline and 4 weeks after randomization|All randomized patients||units on a scale||95% Confidence Interval|Mean
703275|NCT00094497|Other Pre-specified|Impact of Reaching Mitotane Blood Levels Between 14-20 mg/l in Both Arms on Survival and Overall Response Rate||every 8 weeks until progression or until Dec 2010||||||
703276|NCT00094497|Other Pre-specified|Pharmakinetics of Mitotane (Substudy)|To study the relationship between mitotane dose (daily and cumulative) and mitotane plasma concentrations using one of two pre-defined treatment regimens (high-dose and low-dose).|11 time points in the first 12 weeks||||||
703277|NCT00094497|Other Pre-specified|TTP of Both Regimens as Second Line Treatment in Case of Failure of the Other Initial Regime||every 8 weeks until progression or until Dec 2010||||||
703278|NCT00094497|Secondary|Number of Disease-free Patients|complete response or disease-free by time of surgery|every 8 weeks until progression (up to 5 years)|||participants|||Number
703279|NCT00094497|Secondary|Best Overall Response Rate|RECIST 1.0 was used to evaluate response|every 8 weeks up to 5 years|||participants|||Number
703280|NCT00094497|Secondary|Change in Quality of Life as Measured by QLQ-C30|scale ranged from 0 to 100 with higher score meaning greater quality of life|baseline and 8 weeks|participants with data on both time points||units on a scale||Standard Deviation|Mean
703281|NCT00094497|Secondary|Progression-free Survival||every 8 weeks until progression or death up to 5 years|||months||95% Confidence Interval|Median
703282|NCT00094497|Primary|Overall Survival|participants who died among those randomized to first-line therapy|every 8 weeks until death up to 5 years|||participants|||Number
703283|NCT00094536|Primary|Success (Reduction in Menstruation to Normal Levels)|Success is defined as a pictorial bleeding assessment chart (PBAC) score of ≤ 75 at 1-year post-treatment; a score which corresponds to normal menstruation levels.|1 Year|Intention-to-Treat Analysis||Participants|||Count of Participants
703303|NCT00094653|Secondary|Determination of Best Overall Response Rate (BORR)|Response was based on the investigators’ assessment using modified WHO criteria. BORR is defined as the number of subjects whose BOR is complete or partial response (CR or PR) divided by the total number of subjects in the group. BORR was comprised of responder and non-responder. The definition of a responder in BORR was either confirmed CR or PR, and a non-responder was defined as stable disease (SD), progressed disease (PD), unconfirmed CR (uCR), unconfirmed PR (uPR), and not evaluated.|Up to week 24|Intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study.||percentage of participants||95% Confidence Interval|Number
703284|NCT00094575|Secondary|International Index of Erectile Function (IIEF-5)|"Change (over time) since baseline in IIEF-5. The IIEF-5 Score ranges from 5-25 with higher scores indicating better erectile function.
Longitudinal mixed-effects model, adjusted for baseline values, was used to compare the two study arms. Treatment effect and change in quality-of-life measures over time were assessed in repeated measures models (with unstructured covariance) with the assigned repair method and baseline measurements used as covariates.
Least-squares mean changes from baseline were calculated at each time point; the reported overall least squares mean is calculated over all time points."|Outcome was assessed at 6 months and yearly thereafter, up to 9 years|||units on a scale||95% Confidence Interval|Least Squares Mean
703285|NCT00094575|Secondary|European Quality of Life-5 Dimension (EQ-5D) Visual Analog Scale|"Change (over time) since baseline in EQ-5D Visual Analog Scale. The EQ-5D Visual Analog Scale ranges from 0 (death) to 1 (perfect health). Longitudinal mixed-effects model, adjusted for baseline values, was used to compare the two study arms. Treatment effect and change in quality-of-life measures over time were assessed in repeated measures models (with unstructured covariance) with the assigned repair method and baseline measurements used as covariates.
Least-squares mean changes from baseline were calculated at each time point; the reported overall least squares mean is calculated over all time points."|Outcome was assessed at 6 months and yearly thereafter, up to 9 years|||units on a scale||95% Confidence Interval|Least Squares Mean
703286|NCT00094575|Secondary|European Quality of Life-5 Dimension (EQ-5D) Index Score|"Change (over time) since baseline in EQ-5D. The EQ-5D Index Score ('thermometer scale') ranges from 0 (worst health status) to 100 (best health status). Since this outcome captures change since baseline, values could be below 0.
Longitudinal mixed-effects model, adjusted for baseline values, was used to compare the two study arms. Treatment effect and change in quality-of-life measures over time were assessed in repeated measures models (with unstructured covariance) with the assigned repair method and baseline measurements used as covariates.
Least-squares mean changes from baseline were calculated at each time point; the reported overall least squares mean is calculated over all time points."|Outcome was assessed at 6 months and yearly thereafter, up to 9 years|||units on a scale||95% Confidence Interval|Least Squares Mean
703287|NCT00094575|Secondary|SF-36 Physical Component Deaths Included Score (PCTD)|"Change (over time) since baseline in Physical Component Deaths included Score of SF-36.
The PCTD Score ranges from 0-100 with higher scores indicating better health. Longitudinal mixed-effects model, adjusted for baseline values, was used to compare the two study arms. Treatment effect and change in quality-of-life measures over time were assessed in repeated measures models (with unstructured covariance) with the assigned repair method and baseline measurements used as covariates.
Least-squares mean changes from baseline were calculated at each time point; the reported overall least squares mean is calculated over all time points."|Outcome was assessed at 6 months and yearly thereafter, up to 9 years|||units on a scale||95% Confidence Interval|Least Squares Mean
703288|NCT00094575|Secondary|SF-36 Physical Component Score (PCS)|"Change (over time) since baseline in Physical Component Score of SF-36. The PCS Score ranges from 0-100 with higher scores indicating better health Longitudinal mixed-effects model, adjusted for baseline values, was used to compare the two study arms. Treatment effect and change in quality-of-life measures over time were assessed in repeated measures models (with unstructured covariance) with the assigned repair method and baseline measurements used as covariates.
Least-squares mean changes from baseline were calculated at each time point; the reported overall least squares mean is calculated over all time points."|Outcome was assessed at 6 months and yearly thereafter, up to 9 years|||units on a scale||95% Confidence Interval|Least Squares Mean
703289|NCT00094575|Secondary|SF-36 Mental Component Score (MCS)|"Change (over time) since baseline in Mental Component Score of SF-36. The MCS Score ranges from 0-100 with higher scores indicating better health. Longitudinal mixed-effects model, adjusted for baseline values, was used to compare the two study arms. Treatment effect and change in quality-of-life measures over time were assessed in repeated measures models (with unstructured covariance) with the assigned repair method and baseline measurements used as covariates.
Least-squares mean changes from baseline were calculated at each time point; the reported overall least squares mean is calculated over all time points."|Outcome was assessed at 6 months and then yearly, up to 9 years|||units on a scale||95% Confidence Interval|Least Squares Mean
703290|NCT00094575|Secondary|Secondary Therapeutic Procedures|This outcome includes any procedure that resulted directly or indirectly from the initial procedure and that required a separate trip to the procedure suite (with each trip to the procedure suite counting as one secondary procedure), including any unplanned surgical procedures within 30 days after the initial procedure and any additional aortoiliac procedures at any time.|Participants were followed for the duration of the study, up to 9 years|||participants|||Number
703291|NCT00094575|Primary|All-cause Mortality|Participants vital status was assessed from randomization to end of study follow-up [10/15/2011] or death [whichever occurred first].|Participants were followed for the duration of the study, up to 9 years|||participants|||Number
703292|NCT00094653|Secondary|Clinically Meaningful Changes in Vital Signs and Physical Examinations|Clinically meaningful changes were according to investigator. Vital sign measurements include height, weight, temperature, pulse, and resting systolic and diastolic blood pressure.|vital signs and physical examination were evaluated at screening and at Weeks 1, 4, 7, 10, 12, 16, 20, 24, 28, 36, and every 3 months thereafter|All subjects who received at least 1 dose or any partial dose of study medication.||participants|||Number
703293|NCT00094653|Secondary|Percentage of Participants With Worst On-Study Renal Abnormalities|CTCAE v3.0 Grades 0 through 4 of severity for each AE based on this general guideline: Grade 0=Normal, Grade 1=Mild AE, Grade 2=Moderate AE, Grade 3=Severe AE, Grade 4=Life-threatening or disabling AE.|On-study adverse events include all AEs reported between the first dose and 70 days after the last dose of study therapy (end of the study was defined as the time at which 481 deaths were observed [264 weeks]).|All subjects who received at least 1 dose or any partial dose of study medication. N=Number of participants analyzed; n=number of participants with given laboratory evaluation.||percentage of participants|||Number
703315|NCT00094770|Secondary|Number of Participants With Drug-related LAEs at Week 104|Participants with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs.|Baseline to Week 104|All randomized participants who received at least 1 dose of the double-blind study therapy.||Participants|||Number
707359|NCT00122369|Primary|Pain Ratings at Specified Time Point During the Procedure|Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain|10 min|Patients remaining on procedure table||units on a scale||Inter-Quartile Range|Median
703294|NCT00094653|Secondary|Percentage of Participants With Worst On-Study Liver Abnormalities|ALT=alanine aminotransferase; AST=aspartate aminotransferase. CTCAE v3.0 Grades 0 through 4 of severity for each AE based on this general guideline: Grade 0=Normal, Grade 1=Mild AE, Grade 2=Moderate AE, Grade 3=Severe AE, Grade 4=Life-threatening or disabling AE.|On-study adverse events include all AEs reported between the first dose and 70 days after the last dose of study therapy (end of the study was defined as the time at which 481 deaths were observed [264 weeks]).|All subjects who received at least 1 dose or any partial dose of study medication. N=Number of participants analyzed; n=number of participants with given laboratory evaluation.||percentage of participants|||Number
703295|NCT00094653|Secondary|Percentage of Participants With Worst On-Study Hematological Abnormalities|ANC=Absolute Neutrophil Count. CTCAE v3.0 Grades 0 through 4 of severity for each AE based on this general guideline: Grade 0=Normal, Grade 1=Mild AE, Grade 2=Moderate AE, Grade 3=Severe AE, Grade 4=Life-threatening or disabling AE.|On-study laboratory results are results reported after the first dose date and within 70 days of last dose of study therapy (end of the study was defined as the time at which 481 deaths were observed [264 weeks]).|All subjects who received at least 1 dose or any partial dose of study medication. N=Number of participants analyzed; n=number of participants with given laboratory evaluation.||percentage of participants|||Number
703296|NCT00094653|Secondary|Percentage of Participants With Immune-Related Adverse Events (irAEs)|"An immune related adverse event (irAE) was defined as an adverse event of unknown etiology, associated with study drug exposure and consistent with an immune phenomenon. The irAEs were programmatically determined from a predefined list of MedDRA version 12.0 high-level group terms, high-level terms and preferred terms of all ipilimumab related adverse event. The category of Other irAEs includes blood, eye, immune, infections, renal, and respiratory systems."|On-study adverse events include all AEs reported between the first dose and 70 days after the last dose of study therapy (end of the study was defined as the time at which 481 deaths were observed [264 weeks]).|All subjects who received at least 1 dose or any partial dose of study medication.||percentage of participants|||Number
703297|NCT00094653|Secondary|Percentage of Participants With On-Study Adverse Events (AEs) and AEs With an Outcome of Death|An AE was defined as any undesirable sign, symptom, clinically significant laboratory abnormality, or medical condition occurring after starting study treatment, even if the event was not considered to be treatment-related. Adverse events are graded using the Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0. If CTCAE grading does not exist for an adverse event, the intensity of mild (1), moderate (2), severe (3), and life-threatening (4) were used.|On-study adverse events include all AEs reported between the first dose and 70 days after the last dose of study therapy (end of the study was defined as the time at which 481 deaths were observed [264 weeks]).|All subjects who received at least 1 dose or any partial dose of study medication.||percentage of participants|||Number
703298|NCT00094653|Secondary|Change From Baseline in Health-Related Quality of Life (QOL) as Measured by the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Instrument at Week 12|The 30 items were grouped into the following: 1 global QOL scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). All scores were linearly transformed to a 0 to 100 scale. For global QOL and functional items, a higher score represents a better level of functioning (100=best/0=worst). For symptom items, a higher score represents a higher level of symptoms (0=no symptom at all/100=very much severe).|Baseline (Day 1, Cycle1), Week 12|All subjects who received at least 1 dose or any partial dose of study medication. N=number of participants analyzed, n=number of participants with measure at given time points.||units on a scale||95% Confidence Interval|Least Squares Mean
703299|NCT00094653|Secondary|Delayed Response (Response Beyond Week 24)|Response was based on the investigators' assessment using modified World Health Organization (WHO) criteria. Delayed response is defined as post Week 24 overall response for the subjects who have PD before or at Week 24. Evaluation of delayed overall response is compared to baseline assessment. Delayed response includes delayed late CR, delayed late PR, delayed late SD, continued PD, unknown, and missing after Week 24. The delayed response of CR and PR also must have been confirmed.|from Week 24 to end of study (the end of the study was defined as the time at which 481 deaths were observed [264 weeks])|Number of subjects with BOR of PR/SD (80 subjects ipi + gp100 , 37 ipi , 15 gp100) plus number of subjects with BOR of PD that had subsequent evaluation (8 ipi + gp100, 3 ipi, 3 gp100).||participants|||Number
703300|NCT00094653|Secondary|Disease Control Rate (DCR)|Response was based on the investigators' assessment using modified WHO criteria. DCR is defined as the number of subjects whose BOR is CR, PR, or SD divided by the total number of subjects in the group.|Up to week 24|Intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study.||percentage of participants||95% Confidence Interval|Number
703301|NCT00094653|Secondary|Duration of Response|Kaplan-Meier medians along with Brookmeyer and Crowley 95% confidence intervals (CI) for were computed. Duration of response was defined in subjects whose BOR was CR or PR as the number of days between the date of response (CR or PR) and the date of PD or the date of death (whichever occurs first).|from time of initial drug administration to date of PD or death due to PD (the end of the study was defined as the time at which 481 deaths were observed [264 weeks])|Responders only in intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study. Patients who did not progress or died were censored at the date of their last tumor assessment.||months||95% Confidence Interval|Median
703302|NCT00094653|Secondary|Time to Response|Time to response was defined as the number of days from the date of randomization to the date when measurement criteria are met for BOR of CR or PR, as determined by investigator.|From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks)|Responder subjects in intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study.||months||Full Range|Mean
703316|NCT00094770|Secondary|Number of Participants With Serious LAEs at Week 104|Serious LAEs are any LAEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.|Baseline to Week 104|All randomized participants who received at least 1 dose of the double-blind study therapy.||Participants|||Number
703304|NCT00094653|Secondary|Best Overall Response (BOR): Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressed Disease (PD)|Investigator’s assessment, modified World Health Organization criteria. CR: disappearance of all lesions by 2 consecutive observations >=4 weeks apart, no evidence of PD. PR: >=50% ↓ in sum of products of longest diameter & greatest perpendicular diameter of all target lesions compared to baseline by 2 observations >=4 weeks apart. SD: Neither sufficient ↓ to qualify for PR nor sufficient ↑ to qualify for PD. PD: ↑ >=25% in sum of products of longest diameter & greatest perpendicular diameter of target lesions compared to smallest recorded sum during study, or appearance of >= 1 new lesion.|BOR was determined between Weeks 12 and Week 24 confirmation at least 4 weeks later at Cycle 1.|Intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study.||participants|||Number
703305|NCT00094653|Secondary|Time to Progression (TTP)|TTP was defined as the number of days between the date of the randomization and date of PD or death due to PD. For subjects who had not progression and remained alive, TTP was censored on the date of last assessment; those who remained alive and had no recorded post-baseline assessment, TTP was censored on the date of randomization; those who remained alive and had randomized but were not treated, TTP was censored at the date of randomization; for those who died without reported disease progression, TTP was censored on the date of death.|from time of randomization to date of PD or death due to PD (end of the study was defined as the time at which 481 deaths were observed [264 weeks])|Intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study.||months||95% Confidence Interval|Median
703306|NCT00094653|Secondary|Percentage of Participants With Progression Free Survival (PFS) at Week 12 and Week 24|PFS at Week 12 was defined as the probability that the subject was progression-free at 12 weeks and 24 weeks following the start of randomization. It was computed via Kaplan-Meier method, truncated at Week 12 and Week 24. PFS was determined by investigator. 95% confidence intervals (CI) for median were computed using Brookmeyer and Crowley method.|Week 12, Week 24|Intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study.||percentage of participants||95% Confidence Interval|Median
703307|NCT00094653|Secondary|Progression Free Survival (PFS)|PFS was defined as the number of days between the date of randomization and the date of the progression or the date of death. A subject who died without prior progression was considered to have progressed on the date of death. PFS was determined by investigator. 95% confidence intervals (CI) for median were computed using Brookmeyer and Crowley method.|From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks)|Intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study. Subjects who neither progressed nor died were censored at the date of the last tumor assessment.||months||95% Confidence Interval|Median
703308|NCT00094653|Secondary|12-, 18-, and 24-Month Survival Rates|The probability that a subject is alive at 12 months, 18 months, and 24 months following randomization, estimated via the non-parametric method (Kaplan-Meier method). For calculating 95% CI, bootstrap method was used with 20000 simulated trials.|Month 12, Month 18, Month 24|Intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study.||probability||95% Confidence Interval|Number
703309|NCT00094653|Secondary|Overall Survival (OS) (Time-to-Death) Difference Between MDX-010 Monotherapy Versus gp100 Melanoma Peptide Vaccine Alone and MDX-010 in Combination With gp100 Melanoma Peptide Vaccine Versus MDX-010 Monotherapy|OS was defined as the time from randomization until death from any cause. If a participant did not expire, the subject was censored at the time of last contact (last known alive date). 95% confidence intervals (CI) for median were computed using Brookmeyer and Crowley method.|From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks)|Intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study.||months||95% Confidence Interval|Median
703310|NCT00094653|Primary|Overall Survival (OS) (Time-to-Death) Difference Between MDX-010 in Combination With gp 100 Melanoma Peptide Vaccine Versus gp 100 Melanoma Peptide Vaccine Alone|OS was defined as the time from randomization until death from any cause. If a participant did not expire, the subject was censored at the time of last contact (last known alive date). 95% confidence intervals (CI) for median were computed using Brookmeyer and Crowley method.|From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks)|Intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study.||months||95% Confidence Interval|Median
703311|NCT00094757|Secondary|Change From Baseline in FPG at Week 54|The change from baseline reflects the Week 54 FPG minus the Week 0 FPG.|Weeks 0-54|All Patients Treated included patients who received at least 1 dose of study therapy 1 post-Week 18, a baseline value and ≥1 post-Week 18 value for this outcome. The last post- Week 18 observed measurement was carried forward to Week 54 for patients with no data at Week 54. Data after initiation of glycemic rescue were considered missing.||mg/dL||95% Confidence Interval|Least Squares Mean
703312|NCT00094757|Secondary|Change From Baseline in A1C at Week 54|A1C is measured as percent. Thus this change from baseline reflects the Week 54 A1C percent minus the Week 0 A1C percent.|Weeks 0-54|All Patients Treated included patients who received at least 1 dose of study therapy post-Week 18, a baseline value and ≥1 post-Week 18 value for this outcome. The last post- Week 18 observed measurement was carried forward to Week 54 for patients with no data at Week 54. Data after initiation of glycemic rescue were considered missing.||percent||95% Confidence Interval|Least Squares Mean
703313|NCT00094757|Secondary|Change From Baseline in FPG at Week 18|The change from baseline reflects the Week 18 Fasting Plasma Glucose (FPG) minus the Week 0 FPG.|Weeks 0-18|All Patients Treated included patients who received at least 1 dose of study therapy, and had a baseline value and ≥1 post-baseline value for this outcome. The last post-baseline observed measurement was carried forward to Week 18 for patients with no data at Week 18. Data after initiation of glycemic rescue were considered missing.||mg/dL||95% Confidence Interval|Least Squares Mean
703314|NCT00094757|Primary|Change From Baseline in A1C at Week 18|Hemoglobin A1C (A1C) is measured as percent. Thus this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.|Weeks 0-18|All Patients Treated included those with ≥1 dose of study therapy, had a baseline and ≥1 post-baseline value. For those with no data at Week 18, last post-baseline observation was carried forward. Data after initiation of glycemic rescue were considered missing. Analysis adjusted for baseline values and prior antihyperglycemic therapy status.||percent||95% Confidence Interval|Least Squares Mean
703317|NCT00094770|Secondary|Number of Participants With Laboratory Adverse Experiences (LAEs) at Week 104|A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product.|Baseline to Week 104|All randomized participants who received at least 1 dose of the double-blind study therapy.||Participants|||Number
703318|NCT00094770|Secondary|Number of Participants With Drug-related CAEs at Week 104|Participants with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs.|Baseline to Week 104|All randomized participants who received at least 1 dose of the double-blind study therapy.||Participants|||Number
703319|NCT00094770|Secondary|Number of Participants With Serious CAEs at Week 104|Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose.|Baseline to Week 104|All randomized participants who received at least 1 dose of the double-blind study therapy.||Participants|||Number
703320|NCT00094770|Secondary|Number of Participants With Clinical Adverse Experiences (CAEs) at Week 104|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product.|Baseline to Week 104|All randomized participants who received at least 1 dose of the double-blind study therapy.||Participants|||Number
703321|NCT00094770|Secondary|Hypoglycemic Events at Week 104|Number of participants who reported 1 or more episodes of the adverse experience of hypoglycemia.|Baseline to Week 104|All randomized participants who received at least 1 dose of the double-blind study therapy.||Participants|||Number
703322|NCT00094770|Secondary|Hypoglycemic Events at Week 52|Number of participants who reported 1 or more episodes of the adverse experience (AEs) of hypoglycemia.|Baseline to Week 52|All randomized participants who received at least 1 dose of the double-blind study therapy.||Participants|||Number
703323|NCT00094770|Secondary|Change From Baseline in Body Weight at Week 104|Change from baseline at Week 104 is defined as Week 104 minus Week 0.|Baseline and Week 104|The All-Patient-as-Treated (APaT) population required that a participant received at least 1 dose of double-blind study therapy. No missing data were imputed.||Kilograms||95% Confidence Interval|Least Squares Mean
703324|NCT00094770|Secondary|Change From Baseline in Body Weight at Week 52|Change from baseline at Week 52 is defined as Week 52 minus Week 0.|Baseline and Week 52|The All-Patient-as-Treated (APaT) population required that a participant received at least 1 dose of double-blind study therapy. No missing data were imputed.||Kilograms||95% Confidence Interval|Least Squares Mean
703325|NCT00094770|Secondary|Change From Baseline in HbA1c at Week 104|HbA1c is measured as percent. Thus, this change from baseline reflects the Week 104 HbA1c percent minus the Week 0 HbA1c percent.|Baseline and Week 104|The per protocol population required that a participant had measurements both at baseline and at Week 104, and did not have any major protocol violations (e.g. drug compliance < 75%, addition of prohibited antihyperglycemic agent, incorrect double-blind study medication). No missing data were imputed.||Percent||95% Confidence Interval|Least Squares Mean
703326|NCT00094770|Primary|Change From Baseline in HbA1c at Week 52|HbA1c is measured as percent. Thus, this change from baseline reflects the Week 52 HbA1c percent minus the Week 0 HbA1c percent.|Baseline and Week 52|The per protocol population required that a participant had measurements both at baseline and at Week 52, and did not have any major protocol violations (e.g. drug compliance < 75%, addition of prohibited antihyperglycemic agent, incorrect double-blind study medication). No missing data were imputed.||Percent||95% Confidence Interval|Least Squares Mean
703327|NCT00094809|Primary|Grade 4 Neutropenia|Grade 4 neutropenia, defined as an absolute neutrophil count (ANC) <0.5 x 10^9/L, in any of the first four cycles of treatment|First 4 cycles of treatment (8 weeks)|Primary Analysis Set, composed of all participants who received study drug and who signed an informed consent before any invasive procedures||Participants|||Number
703328|NCT00094809|Secondary|Antibiotic Use Due to Febrile Neutropenia|Antibiotic use during any of the first 4 cycles of treatment due to febrile neutropenia.|First 4 cycles of treatment (8 weeks)|Primary Analysis Set, composed of all participants who received study drug and who signed an informed consent before any invasive procedures||Participants|||Number
703329|NCT00094809|Secondary|Survival|Death from any cause through the end of the follow-up period|Up to 24 months after first four cycles of treatment|Primary Analysis Set, composed of all participants who received study drug and who signed an informed consent before any invasive procedures.||Participants|||Number
703330|NCT00094809|Secondary|Objective Tumor Response|Objective tumor response (complete or partial) at the end of treatment, defined as a reduction of at least 50% in the area of all measurable lesions (partial response) or disappearance of all measurable or evaluable disease without the development of new lesions (complete response) on computed tomographic (CT) or other scanning.|First 4 cycles of treatment (8 weeks)|Primary Analysis Set, composed of all participants who received study drug and who signed an informed consent before any invasive procedures||Participants|||Number
703331|NCT00094809|Secondary|Progression-Free Survival|Kaplan-Meier estimate of the median time to disease progression or death|Up to 24 months after first four cycles of treatment|Primary Analysis Set, composed of all participants who received study drug and who signed an informed consent before any invasive procedures||Days||95% Confidence Interval|Median
703332|NCT00094809|Secondary|Hospitalization Due to a Neutropenia-Related Event|Hospitalization because of a neutropenia-related event during the first 4 cycles of treatment|First 4 cycles of neutropenia (8 weeks)|Primary Analysis Set, composed of all participants who received study drug and who signed an informed consent before any invasive procedures||Participants|||Number
703333|NCT00094809|Secondary|Febrile Neutropenia|Febrile neutropenia, Defined as a temperature ≥ 38.2 °C on a given day, with an ANC < 1.0 x 10^9/L recorded on the same day or the next day, during any of the first 4 cycles of treatment.|First 4 cycles of treatment (8 weeks)|Primary Analysis Set, composed of all participants who received study drug and who signed an informed consent before any invasive procedures||Participants|||Number
703334|NCT00094809|Secondary|Dose Delay or Reduction for Any Reason|Dose delay or reduction in chemotherapy dose during the first 4 cycles for any reason|First 4 cycles of treatment (8 weeks)|Primary Analysis Set, composed of all participants who received study drug and who signed an informed consent before any invasive procedures||Participants|||Number
703335|NCT00094809|Secondary|Dose Delay or Reduction Due to Neutropenia|Dose delay or reduction in chemotherapy doses due to neutropenia|First 4 cycles of treatment (8 weeks)|Primary Analysis Set, composed of all participants who received study drug and who signed an informed consent before any invasive procedures||Participants|||Number
703336|NCT00094809|Primary|Grade 3 or 4 Neutropenia|Grade 3 or 4 neutropenia, defined as an absolute neutrophil count (ANC) < 1 x 10^9/L, in any of the first four cycles of treatment|First 4 cycles of treatment (8 weeks)|Primary Analysis Set, composed of all participants who received study drug and who signed an informed consent before any invasive procedures||Participants|||Number
703337|NCT00094835|Primary|Trough Plasma Concentration at 24 Hours Post-dose (C24) for Motesanib in Cycle 2|The trough plasma concentration for motesanib at 24 hours postdose in Cycle 2. For the 75 BID cohort, C24 is the observed concentration at 24 hours (ie, after the second daily dose).|Cycle 2, Day 1, 24 hours post-dose|PK Population. Participants with elevated motesanib concentrations at 24 hours were excluded from the calculations. Summary results are not presented for two treatment groups for which the sample size was smaller than 3.||ng/mL||Standard Deviation|Mean
703338|NCT00094835|Primary|Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours Post-dose for Motesanib in Cycle 2|Area under the plasma concentration-time curve from time 0 to 24 hours post-dose (AUC0-24) for motesanib in Cycle 2 calculated using the using the linear/log trapezoidal method. For the 75 mg BID cohort AUC0-24 is the sum of AUC0-12 for the first and second daily dose.|Cycle 2, Day 1 at predose, 15 and 30 minutes, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours post-dose.|PK Population. Participants with elevated motesanib concentrations at 24 hours were excluded from the calculations. Summary results are not presented for two treatment groups for which the sample size was smaller than 3.||μg*hr/mL||Standard Deviation|Mean
703339|NCT00094835|Primary|Estimated Terminal-phase Half-life (t1/2,z) of Motesanib in Cycle 2|The terminal-phase elimination half-life (t1/2,z) of motesanib was calculated as ln(2)/λz. The terminal elimination rate constant (λz) was determined by linear regression of the natural logarithms of at least the last 3 measurable concentrations during the terminal phase. For the 75 mg BID cohorts, t1/2,z is reported for the first daily dose.|Cycle 2, Day 1 at predose, 15 and 30 min, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours post-dose.|PK Population. Participants with elevated motesanib concentrations at 24 hours were excluded from the calculations. Summary results are not presented for three treatment groups for which the sample size was smaller than 3.||hours||Standard Deviation|Mean
703340|NCT00094835|Primary|Maximum Observed Plasma Concentration of Motesanib (Cmax) in Cycle 2|The maximal observed plasma concentration of motesanib in Cycle 2, after multiple doses. For the 75 mg BID cohorts, Cmax is reported for the first daily dose.|Cycle 2, Day 1 at predose, 15 and 30 min, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours post-dose.|PK population||ng/mL||Standard Deviation|Mean
703341|NCT00094835|Primary|Time to Maximum Plasma Concentration of Motesanib (Tmax) in Cycle 2|The time after dosing that the maximal plasma concentration of motesanib was observed in Cycle 2. For the 75 mg BID cohorts, Tmax is reported for the first daily dose.|Cycle 2, Day 1 at predose, 15 and 30 min, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours post-dose.|PK population||hours||Full Range|Median
703342|NCT00094835|Primary|Trough Plasma Concentration at 24 Hours Post-dose (C24) for Motesanib in Cycle 1|The trough plasma concentration for motesanib at 24 hours postdose in Cycle 1. For the 75 BID cohort, C24 is the observed concentration at 24 hours (ie, after the second daily dose).|Cycle 1, Day 3, 24 hours post-dose|PK Population. Participants with elevated motesanib concentrations at 24 hours were excluded from the calculations. Summary results are not presented for the Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD treatment group for which the sample size was smaller than 3.||ng/mL||Standard Deviation|Mean
703343|NCT00094835|Primary|Area Under the Plasma Concentration-time Curve for Motesanib in Cycle 1|Area under the plasma concentration-time curve for motesanib in Cycle 1 calculated using the using the linear/log trapezoidal method. AUC from time zero to infinity (AUC0-inf) is reported for the 50 and 125 mg QD cohorts and AUC from time 0 to 24 hours post-dose (AUC0-24) is reported for the 75 mg BID cohort, where AUC0-24 is the sum of AUC0-12 for the first and second daily dose.|Cycle 1, Day 3 at predose, 15 and 30 minutes, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours post-dose.|PK Population. Participants with elevated motesanib concentrations at 24 hours were excluded from the calculations. Summary results are not presented for the Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD treatment group for which the sample size was smaller than 3.||μg*hr/mL||Standard Deviation|Mean
703344|NCT00094835|Primary|Estimated Terminal-phase Half-life (t1/2,z) of Motesanib in Cycle 1|The terminal-phase elimination half-life (t1/2,z) of motesanib was calculated as ln(2)/λz. The terminal elimination rate constant (λz) was determined by linear regression of the natural logarithms of at least the last 3 measurable concentrations during the terminal phase. For the 75 mg BID cohorts, t1/2,z is reported for the first daily dose.|Cycle 1, Day 3 at predose, 15 and 30 min, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours postdose.|PK Population. Participants with elevated motesanib concentrations at 24 hours were excluded from the calculations. Summary results are not presented for the Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD treatment group for which the sample size was smaller than 3.||hours||Standard Deviation|Mean
703345|NCT00094835|Primary|Maximum Observed Plasma Concentration of Motesanib (Cmax) in Cycle 1|The maximal observed plasma concentration of motesanib after a single dose dose in Cycle 1. For the 75 mg BID cohorts, Cmax is reported for the first daily dose.|Cycle 1, Day 3 at predose, 15 and 30 min, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours post-dose.|PK population||ng/mL||Standard Deviation|Mean
703361|NCT00094887|Secondary|Vital Signs||At baseline, then every hour for the first 8 hours of therapy, followed by every 4 hours of therapy.||||||
703362|NCT00094887|Primary|Time to Resolution of Vaso-occlusive Pain Crisis (VOC)|"Time to VOC resolution was defined by:
Pain relief - Visual Analog Scale (VAS) pain scores of 6 or less, (6 as worst and 0 as best) Freedom from parenteral narcotic use, Ability to walk unless the subject was not able to walk for any reason other than acute VOC prior to the onset of crisis, Subject and/or family’s belief that the painful crisis could be managed at home with or without oral analgesic use, and the physician concurred with that assessment."|Up to 30 days|75 subjects were assigned to treatment with iNO and 75 subjects were assigned to treatment with placebo; all subjects were included in the ITT and Safety Populations. 142 subjects completed the study according to the protocol and 8 subjects (4 in each treatment group) did not complete the study according to protocol.||Hours||95% Confidence Interval|Median
703346|NCT00094835|Secondary|Percentage of Participants With an Overall Objective Response|Confirmed objective tumor response defined as a complete response (CR) or partial response (PR) using modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. Tumor response was evaluated by computed tomography (CT) scan or magnetic resonance imaging (MRI). Responding disease (CR or PR) was confirmed no less than 4 weeks after the criteria for response were first met. A complete response defined as the disappearance of all target lesions and all non-target lesions, no new lesions and normalization of tumor marker level. Partial response defined as either the disappearance of all target lesions and the persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of the longest diamer (LD) of target lesions, taking as reference the baseline sum LD and no new lesions and/or unequivocal progression of existing non-target lesions.|After 9 weeks of treatment (at the end of Cycle 3)|Efficacy analysis set, composed of all enrolled participants who received at least one dose of motesanib in treatment arms 1-3 or at least one dose of motesanib with one dose of panitumumab in treatmnt arms 4-7.||Percentage of participants|||Number
703347|NCT00094835|Primary|Time to Maximum Plasma Concentration of Motesanib (Tmax) for Cycle 1|The time after dosing that the maximal plasma concentration of motesanib was observed in Cycle 1. For the 75 mg BID cohorts, Tmax is reported for the first daily dose.|Cycle 1, Day 3 at predose, 15 and 30 minutes, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours post-dose.|The pharmacokinetic (PK) population consisted of all consented patients who received motesanib and had evaluable pharmacokinetic data and did not have significant protocol deviations that affected the data or key-dosing information that was missing.||hours||Full Range|Median
703348|NCT00094861|Secondary|Maximal Body Weight Loss|Maximal weight loss observed from Baseline through to Week 12.|Baseline through Week 12|Full analysis set with available data||kilograms||Standard Deviation|Mean
703349|NCT00094861|Secondary|Number of Participants Hospitalized||Baseline to Week 16|Full analysis set||participants|||Number
703350|NCT00094861|Secondary|Maximal Eastern Cooperative Oncology Group (ECOG) Performance Status Increase|"Maximal increase from Baseline in Eastern Cooperative Oncology Group (ECOG) performance status. ECOG is a scale to assess how a patient's disease is progressing, how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis.
Grade 0: Fully active, able to carry on all pre-disease performance without restriction; Grade 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; Grade 2: Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours; Grade 3: Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours; Grade 4: Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair; Grade 5: Dead."|Baseline through Week 12|Full analysis set participants with available ECOG data||units on a scale||Standard Deviation|Mean
703351|NCT00094861|Secondary|Number of Participants With Unplanned Breaks in Radiotherapy|The number of participants with unplanned breaks in radiotherapy of ≥ 5 days or who discontinued radiotherapy during Week 1 to Week 6.|Week 1 to Week 6|Full analysis set||participants|||Number
703352|NCT00094861|Secondary|Number of Participants With Severe (Grade 3 or Higher) Dysphagia|"Participants underwent acute dysphagia assessments twice weekly during Weeks 1 through 7, and twice weekly thereafter (Weeks 8 through 12) and once weekly after Week 12 until dysphagia resolved to grade ≤ 1 but not beyond Week 16. Dysphagia (difficulty swallowing) was graded using the Common Terminology Criteria for Adverse Events, Version 3.0 (CTCAE v3.0) dysphagia scale according to the following:
Grade 1: Symptomatic, able to eat regular diet; Grade 2: Symptomatic and altered eating/swallowing (e.g., altered dietary habits, oral supplements), IV fluids indicated <24 hours; Grade 3: Symptomatic and severely altered eating/swallowing (e.g., inadequate oral caloric or fluid intake), IV fluids, tube feedings, or total parenteral nutrition (TPN) indicated ≥24 hours; Grade 4: Life-threatening consequences (e.g., obstruction, perforation)."|Start of treatment through Week 16|Full analysis set||participants|||Number
703353|NCT00094861|Secondary|Maximal Dysphagia Grade|"The mean maximal grade of dysphagia for each participant during the study. Dysphagia (difficulty swallowing) was graded using the Common Terminology Criteria for Adverse Events, Version 3.0 (CTCAE v3.0) dysphagia scale according to the following:
Grade 1: Symptomatic, able to eat regular diet; Grade 2: Symptomatic and altered eating/swallowing (e.g., altered dietary habits, oral supplements), IV fluids indicated <24 hours; Grade 3: Symptomatic and severely altered eating/swallowing (e.g., inadequate oral caloric or fluid intake), IV fluids, tube feedings, or total parenteral nutrition (TPN) indicated ≥24 hours; Grade 4: Life-threatening consequences (e.g., obstruction, perforation)."|Start of treatment through Week 16|Full analysis set participants with dysphagia assessments.||grade||Standard Deviation|Mean
703354|NCT00094861|Secondary|Duration of Grade 2 or Higher Dysphagia|"Duration of grade 2 or higher dysphagia was calculated in days from the onset (first occurrence of grade ≥ 2) to the resolution (grade ≤ 1 after the last grade ≥ 2) of dysphagia.
Participants with no assessments were assumed as having grade ≥ 2 dysphagia and with a duration of the mean duration of all participants."|Start of treatment through Week 16|Full analysis set||days||Standard Deviation|Mean
703355|NCT00094861|Primary|Number of Participants With Grade 2 or Higher Dysphagia|"Participants underwent acute dysphagia assessments twice weekly during Weeks 1 through 7, and twice weekly thereafter (Weeks 8 through 12) and once weekly after Week 12 until dysphagia resolved to grade ≤ 1 but not beyond Week 16. Dysphagia (difficulty swallowing) was graded using the Common Terminology Criteria for Adverse Events, Version 3.0 (CTCAE v3.0) dysphagia scale according to the following:
Grade 1: Symptomatic, able to eat regular diet; Grade 2: Symptomatic and altered eating/swallowing (e.g., altered dietary habits, oral supplements), IV fluids indicated <24 hours; Grade 3: Symptomatic and severely altered eating/swallowing (e.g., inadequate oral caloric or fluid intake), IV fluids, tube feedings, or total parenteral nutrition (TPN) indicated ≥24 hours; Grade 4: Life-threatening consequences (e.g., obstruction, perforation)."|Start of treatment through Week 16|Full analysis set||participants|||Number
703356|NCT00094887|Secondary|Rate of Acute Chest Syndrome/Pneumonia Requiring Blood Transfusion||study duration||||||
703357|NCT00094887|Secondary|Length of Hospitalization From Admissions Defined by the Time of the Discharge Order is Written||study duration||||||
703358|NCT00094887|Secondary|Blood Chemistry Levels||every 24 hours for the first 5 days after start of treatment.||||||
703359|NCT00094887|Secondary|Need for Analgesics||baseline and throughout treatment.||||||
703360|NCT00094887|Secondary|Methemoglobin Levels||at 2,4,6, and 8 hours after the start of therapy and then every 24 hours while on therapy.||||||
703367|NCT00094900|Secondary|Mean Change in Swollen Joint Count in AOSD Subjects|Count of swollen joints in patient from baseline to 24 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|24 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||swollen joints||Standard Error|Mean
703368|NCT00094900|Secondary|Mean Change in Swollen Joint Count in AOSD Subjects|Count of swollen joints in patient from baseline to 12 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|12 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||swollen joints||Standard Error|Mean
703369|NCT00094900|Secondary|Mean Change in Swollen Joint Count in AOSD Subjects|Count of swollen joints in patient from baseline to 6 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|6 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||swollen joints||Standard Error|Mean
703370|NCT00094900|Secondary|Mean Change in Swollen Joint Count in AOSD Subjects|Count of swollen joints in patient from baseline to 3 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|3 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||swollen joints||Standard Error|Mean
703371|NCT00094900|Secondary|Mean Change in Tender Joint Count in AOSD Subjects|Count of tender joints in patient from baseline to 24 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|24 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||tender joints||Standard Error|Mean
703372|NCT00094900|Secondary|Mean Change in Tender Joint Count in AOSD Subjects|Count of tender joints in patient from baseline to 12 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|12 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||tender joints||Standard Error|Mean
703373|NCT00094900|Secondary|Mean Change in Tender Joint Count in AOSD Subjects|Count of tender joints in patient from baseline to 6 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|6 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||tender joints||Standard Error|Mean
703374|NCT00094900|Secondary|Mean Change in Tender Joint Count in AOSD Subjects|Count of tender joints in patient from baseline to 3 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|3 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||tender joints||Standard Error|Mean
703375|NCT00094900|Secondary|Mean Change in Patient’s Global Assessment, by VAS in AOSD Subjects|Patient's global assessment change by visual analog scale from baseline to 24 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|24 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||units on a scale||Standard Error|Mean
703376|NCT00094900|Secondary|Mean Change in Patient’s Global Assessment, by VAS in AOSD Subjects|Patient's global assessment change by visual analog scale from baseline to 12 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|12 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||units on a scale||Standard Error|Mean
703377|NCT00094900|Secondary|Mean Change in Patient’s Global Assessment, by VAS in AOSD Subjects|Patient's global assessment change by visual analog scale from baseline to 6 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|6 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||units on a scale||Standard Error|Mean
703378|NCT00094900|Secondary|Mean Change in Patient’s Global Assessment, by VAS in AOSD Subjects|Patient's global assessment change by visual analog scale from baseline to 3 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|3 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||units on a scale||Standard Error|Mean
703379|NCT00094900|Secondary|Mean Change in Erythrocyte Sedimentation Rate||24 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||mm/hour||Standard Error|Mean
703380|NCT00094900|Secondary|Mean Change in Erythrocyte Sedimentation Rate||12 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||mm/hour||Standard Error|Mean
703381|NCT00094900|Secondary|Mean Change in Erythrocyte Sedimentation Rate||6 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||mm/hour||Standard Error|Mean
703382|NCT00094900|Secondary|Mean Change in Erythrocyte Sedimentation Rate||3 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||mm/hour||Standard Error|Mean
703399|NCT00094900|Secondary|Mean Change in SF-36 Mental Component Score|Short Form 36 health survey (range 0–100 for each component score), mental component score, taken by patient from baseline to 24 months. Lower scores indicate feeling depressed, anxious all the time, while higher scores indicate a state of happiness and peacefulness. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection.Med Care 1992;30:473–83.)|24 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
703400|NCT00094900|Secondary|Mean Change in SF-36 Mental Component Score|Short Form 36 health survey (range 0–100 for each component score), mental component score, taken by patient from baseline to 20 months. Lower scores indicate feeling depressed, anxious all the time, while higher scores indicate a state of happiness and peacefulness. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection.Med Care 1992;30:473–83.)|20 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
703401|NCT00094900|Secondary|Mean Change in SF-36 Mental Component Score|Short Form 36 health survey (range 0–100 for each component score), mental component score, taken by patient from baseline to 16 months. Lower scores indicate feeling depressed, anxious all the time, while higher scores indicate a state of happiness and peacefulness. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection.Med Care 1992;30:473–83.)|16 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
703402|NCT00094900|Secondary|Mean Change in SF-36 Mental Component Score|Short Form 36 health survey (range 0–100 for each component score), mental component score, taken by patient from baseline to 12 months. Lower scores indicate feeling depressed, anxious all the time, while higher scores indicate a state of happiness and peacefulness. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection.Med Care 1992;30:473–83.)|12 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
703403|NCT00094900|Secondary|Mean Change in SF-36 Mental Component Score|Short Form 36 health survey (range 0–100 for each component score), mental component score, taken by patient from baseline to 9 months. Lower scores indicate feeling depressed, anxious all the time, while higher scores indicate a state of happiness and peacefulness. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection.Med Care 1992;30:473–83.)|9 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
703404|NCT00094900|Secondary|Mean Change in SF-36 Mental Component Score|Short Form 36 health survey (range 0–100 for each component score), mental component score, taken by patient from baseline to 6 months. Lower scores indicate feeling depressed, anxious all the time, while higher scores indicate a state of happiness and peacefulness. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection.Med Care 1992;30:473–83.)|6 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
703405|NCT00094900|Secondary|Mean Change in SF-36 Mental Component Score|Short Form 36 health survey (range 0–100 for each component score), mental component score, taken by patient from baseline to 3 months. Lower scores indicate feeling depressed, anxious all the time, while higher scores indicate a state of happiness and peacefulness. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection.Med Care 1992;30:473–83.)|3 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
703406|NCT00094900|Secondary|Mean Change in SF-36 Physical Component Score|Short Form 36 health survey (range 0–100 for each component score), physical component score, taken by patient from baseline to 24 months. Lower scores indicate limited physical function, while higher scores indicate higher physical function. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30:473–83.)|24 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
703407|NCT00094900|Secondary|Mean Change in SF-36 Physical Component Score|Short Form 36 health survey (range 0–100 for each component score), physical component score, taken by patient from baseline to 20 months. Lower scores indicate limited physical function, while higher scores indicate higher physical function. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30:473–83.)|20 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
703408|NCT00094900|Secondary|Mean Change in SF-36 Physical Component Score|Short Form 36 health survey (range 0–100 for each component score), physical component score, taken by patient from baseline to 16 months. Lower scores indicate limited physical function, while higher scores indicate higher physical function. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30:473–83.)|16 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
703409|NCT00094900|Secondary|Mean Change in SF-36 Physical Component Score|Short Form 36 health survey (range 0–100 for each component score), physical component score, taken by patient from baseline to 12 months. Lower scores indicate limited physical function, while higher scores indicate higher physical function. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30:473–83.)|12 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
703410|NCT00094900|Secondary|Mean Change in SF-36 Physical Component Score|Short Form 36 health survey (range 0–100 for each component score), physical component score, taken by patient from baseline to 9 months. Lower scores indicate limited physical function, while higher scores indicate higher physical function. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30:473–83.)|9 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
703411|NCT00094900|Secondary|Mean Change in SF-36 Physical Component Score|Short Form 36 health survey (range 0–100 for each component score), physical component score, taken by patient from baseline to 6 months. Lower scores indicate limited physical function, while higher scores indicate higher physical function. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30:473–83.)|6 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Deviation|Mean
703412|NCT00094900|Secondary|Mean Change in SF-36 Physical Component Score|Short Form 36 health survey (range 0–100 for each component score), physical component score, taken by patient from baseline to 3 months. Lower scores indicate limited physical function, while higher scores indicate higher physical function. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30:473–83.)|3 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
703413|NCT00094900|Secondary|Mean Change in Swollen Joint Count|Count of swollen joints in patient from baseline to 24 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|24 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||swollen joints||Standard Error|Mean
703414|NCT00094900|Secondary|Mean Change in Swollen Joint Count|Count of swollen joints in patient from baseline to 20 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|20 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||swollen joints||Standard Error|Mean
703415|NCT00094900|Secondary|Mean Change in Swollen Joint Count|Count of swollen joints in patient from baseline to 16 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|16 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||swollen joints||Standard Error|Mean
703416|NCT00094900|Secondary|Mean Change in Swollen Joint Count|Count of swollen joints in patient from baseline to 12 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|12 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||swollen joints||Standard Error|Mean
703417|NCT00094900|Secondary|Mean Change in Swollen Joint Count|Count of swollen joints in patient from baseline to 9 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|9 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||swollen joints||Standard Error|Mean
703418|NCT00094900|Secondary|Mean Change in Swollen Joint Count|Count of swollen joints in patient from baseline to 6 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|6 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||swollen joints||Standard Error|Mean
703419|NCT00094900|Secondary|Mean Change in Swollen Joint Count|Count of swollen joints in patient from baseline to 3 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|3 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||swollen joints||Standard Error|Mean
703420|NCT00094900|Secondary|Mean Change in Tender Joint Count|Count of tender joints in patient from baseline to 24 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|24 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||tender joints||Standard Error|Mean
703421|NCT00094900|Secondary|Mean Change in Tender Joint Count|Count of tender joints in patient from baseline to 20 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|20 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||tender joints||Standard Error|Mean
703422|NCT00094900|Secondary|Mean Change in Tender Joint Count|Count of tender joints in patient from baseline to 16 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|16 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||tender joints||Standard Error|Mean
703423|NCT00094900|Secondary|Mean Change in Tender Joint Count|Count of tender joints in patient from baseline to 12 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|12 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||tender joints||Standard Error|Mean
703611|NCT00095303|Secondary|Main Study, Risky Sexual Behaviors at 4 Months Post Randomization|For the Main Study, the total score of the ‘HIV/Sex Risk Behaviors’ measure was used as the outcome. Scores ranged from -0.5 to 10.4. The higher the score, the more risky sexual behavior.|4 months post randomization|||units on a scale||Standard Error|Least Squares Mean
703424|NCT00094900|Secondary|Mean Change in Tender Joint Count|Count of tender joints in patient from baseline to 9 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|9 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||tender joints||Standard Error|Mean
703425|NCT00094900|Secondary|Mean Change in Tender Joint Count.|Count of tender joints in patient from baseline to 6 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|6 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||tender joints||Standard Error|Mean
703426|NCT00094900|Secondary|Mean Change in Tender Joint Count|Count of tender joints in patient from baseline to 3 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|3 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||tender joints||Standard Error|Mean
703427|NCT00094900|Secondary|Mean Change in Patient’s Assessment of Fatigue, by VAS|Patient's assessment of fatigue by visual analog scale from baseline to 24 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|24 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
703428|NCT00094900|Secondary|Mean Change in Patient’s Assessment of Fatigue, by VAS|Patient's assessment of fatigue by visual analog scale from baseline to 20 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|20 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
703429|NCT00094900|Secondary|Mean Change in Patient’s Assessment of Fatigue, by VAS|Patient's assessment of fatigue by visual analog scale from baseline to 16 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|16 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
703430|NCT00094900|Secondary|Mean Change in Patient’s Assessment of Fatigue, by VAS|Patient's assessment of fatigue by visual analog scale from baseline to 12 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|12 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
703431|NCT00094900|Secondary|Mean Change in Patient’s Assessment of Fatigue, by VAS|Patient's assessment of fatigue by visual analog scale from baseline to 9 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|9 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
703432|NCT00094900|Secondary|Mean Change in Patient’s Assessment of Fatigue, by VAS|Patient's assessment of fatigue by visual analog scale from baseline to 6 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|6 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
703433|NCT00094900|Secondary|Mean Change in Patient’s Assessment of Fatigue, by VAS|Patient's assessment of fatigue by visual analog scale from baseline to 3 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|3 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
703434|NCT00094900|Secondary|Mean Change in Patient’s Assessment of Pain, by VAS|Patient's global assessment of pain by visual analog scale from baseline to 24 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|24 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
703435|NCT00094900|Secondary|Mean Change in Patient’s Assessment of Pain, by VAS|Patient's global assessment of pain by visual analog scale from baseline to 20 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|20 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
703436|NCT00094900|Secondary|Mean Change in Patient’s Assessment of Pain, by VAS|Patient's global assessment of pain by visual analog scale from baseline to 16 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|16 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
703437|NCT00094900|Secondary|Mean Change in Patient’s Assessment of Pain, by VAS|Patient's global assessment of pain by visual analog scale from baseline to 12 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|12 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
703438|NCT00094900|Secondary|Mean Change in Patient’s Assessment of Pain, by VAS|Patient's global assessment of pain by visual analog scale from baseline to 9 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|9 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
703439|NCT00094900|Secondary|Mean Change in Patient’s Assessment of Pain, by VAS|Patient's global assessment of pain by visual analog scale from baseline to 6 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|6 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
703440|NCT00094900|Secondary|Mean Change in Patient’s Assessment of Pain, by VAS|Patient's global assessment of pain by visual analog scale from baseline to 3 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|3 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
703441|NCT00094900|Secondary|Mean Change in Physician’s Global Assessment, by VAS|Physician's global assessment change by visual analog scale from baseline to 24 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|24 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
703442|NCT00094900|Secondary|Mean Change in Physician’s Global Assessment, by VAS|Physician's global assessment change by visual analog scale from baseline to 20 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|20 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
703443|NCT00094900|Secondary|Mean Change in Physician’s Global Assessment, by VAS|Physician's global assessment change by visual analog scale from baseline to 16 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|16 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
703444|NCT00094900|Secondary|Mean Change in Physician’s Global Assessment, by VAS|Physician's global assessment change by visual analog scale from baseline to 12 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|12 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
703445|NCT00094900|Secondary|Mean Change in Physician’s Global Assessment, by VAS|Physician's global assessment change by visual analog scale from baseline to 9 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|9 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
703446|NCT00094900|Secondary|Mean Change in Physician’s Global Assessment, by VAS|Physician's global assessment change by visual analog scale from baseline to 6 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|6 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
703447|NCT00094900|Secondary|Mean Change in Physician’s Global Assessment, by VAS|Physician's global assessment change by visual analog scale from baseline to 3 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|3 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
703448|NCT00094900|Secondary|Mean Change in Patient’s Global Assessment, by VAS|Patient's global assessment change by visual analog scale from baseline to 24 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|24 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
703449|NCT00094900|Secondary|Mean Change in Patient’s Global Assessment, by VAS|Patient's global assessment change by visual analog scale from baseline to 20 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|20 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
703450|NCT00094900|Secondary|Mean Change in Patient’s Global Assessment, by VAS|Patient's global assessment change by visual analog scale from baseline to 16 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|16 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
703451|NCT00094900|Secondary|Mean Change in Patient’s Global Assessment, by VAS|Patient's global assessment change by visual analog scale from baseline to 12 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|12 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
703452|NCT00094900|Secondary|Mean Change in Patient’s Global Assessment, by VAS|Patient's global assessment change by visual analog scale from baseline to 9 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|9 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
703453|NCT00094900|Secondary|Mean Change in Patient’s Global Assessment, by VAS|Patient's global assessment change by visual analog scale from baseline to 6 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|6 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
703454|NCT00094900|Secondary|Mean Change in Patient’s Global Assessment, by VAS|Patient's global assessment change by visual analog scale from baseline to 3 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|3 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
703455|NCT00094900|Primary|Response to Treatment (ACR20) in Patients With Adult Onset Still's Disease|At the 24 month post-dose visit, an ACR20 responder was defined as someone who achieved at least 20% improvement in the tender and the swollen 28-joint count, and 20% improvement in at least 3 of the following 5 measures: Patient's pain assessment, Patient's global assessment of disease activity, Physician's global assessment of disease activity, Patient self-assessed disability, Acute phase reactant.|24 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||participants|||Number
703456|NCT00094900|Primary|Mean Change in SAA|SAA change from baseline to 10 days.The serum Amyloid A (SAA) is an acute phase reactant measured to evaluate lab parameters of inflammation|10 days for 4 patient, 6 days for 1 patient|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||mg/liter||Standard Error|Mean
703457|NCT00094900|Primary|Mean Change in hsCRP|hsCRP change from baseline to 10 days.The high sensitivity C-reactive protein (hsCRP) is an acute phase reactant measured to evaluate lab parameters of inflammation|10 days for 4 patient, 6 days for 1 patient|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||mg/dl||Standard Error|Mean
703458|NCT00094900|Primary|Mean Change in ESR|ESR change from baseline to 10 days.The Erythrocyte Sedimentation Rate (ESR) is an acute phase reactant measured to evaluate lab parameters of inflammation|10 days for 4 patient, 6 days for 1 patient|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||mm/hour||Standard Error|Mean
703459|NCT00094900|Primary|Mean Change in Daily Scores|Daily scores change from baseline to 10 days. The clinical daily diary scores (a composite score that included fever, rash, and arthritis/arthralgia, with each of the 3 symptoms scored from 0 [no symptom] to 4 [worst symptom], with an overall range score of 0–12).|10 days for 4 patient, 6 days for 1 patient|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
703460|NCT00095056|Secondary|Safety and Tolerability of Sitagliptin Over 54 Weeks|Safety and tolerability were measured in terms of the number of patients with clinical adverse experiences (CAEs), serious CAEs, drug-related CAEs, laboratory adverse experiences (LAEs), serious LAEs, and drug-related LAEs. Drug-relationship was assessed by the study investigator according to his/her best clinical judgment.|Week 0 through Week 54|All patients who took study medication were included in the analysis. Events that occurred after initiation of glycemic rescue therapy were excluded from the analysis of CAEs, drug-related CAEs, LAEs, & drug-related LAEs. Events that occurred after initiation of glycemic rescue therapy were included in the analysis of serious CAEs and serious LAEs.||Participants|||Number
703461|NCT00095056|Primary|Safety and Tolerability of Sitagliptin After 12 Weeks of Treatment|Safety and tolerability were measured in terms of the number of patients with clinical adverse experiences (CAEs), serious CAEs, drug-related CAEs, laboratory adverse experiences (LAEs), serious LAEs, and drug-related LAEs. Drug-relationship was assessed by the study investigator according to his/her best clinical judgment.|Week 0 through Week 12|All patients who took study medication were included in the analysis. Events that occurred after initiation of glycemic rescue therapy were excluded from the analysis of CAEs, drug-related CAEs, LAEs, & drug-related LAEs. Events that occurred after initiation of glycemic rescue therapy were included in the analysis of serious CAEs and serious LAEs.||Participants|||Number
703462|NCT00095121|Secondary|Percentage of Participants With Durable HBeAg Seroconversion|A participant was defined to have durable HBeAg seroconversion only if she/he remained in a seroconverted state (HBeAg−, hepatitis B e antibody + [anti-HBe+]) from the date that she/he first seroconverted through and including her/his last study visit. This endpoint could only be assessed for participants who (HBeAg−) seroconverted on-treatment and subsequently discontinued open-label dosing.|240 weeks|Participants who discontinued treatment because of confirmed HBeAg seroconversion in Weeks 49 to 240 were to remain in the study through Week 240 to monitor the durability of seroconversion. Any participant who formally stopped drug early and restarted, by definition, did not have durable HBeAg seroconversion.||Percentage of participants|||Number
703463|NCT00095121|Secondary|Cumulative Summary of Participants With HBV Genotypic Changes From Baseline (Resistance Surveillance) for Subjects Who Received Combination ADV + Lamivudine Therapy|Resistance surveillance was conducted at Week 240/last on-treatment study visit for all participants who had HBV DNA concentrations greater than or equal to the level of detection (>= 169 copies/mL) by PCR while on combination ADV + lamivudine treatment.|240 weeks|32/173 added lamivudine from Weeks 108 - 144. Last on-ADV sample through Week 240 analyzed; participant omitted from cumulative Week 240 analysis if HBV DNA <169 copies/mL at Week 240/last time point or stopped study drug but remained in study. 2 ADV-ADV participants had ADV/lamivudine-specific, conserved-site mutation, and counted 2x in table.||Participants|||Number
703464|NCT00095121|Secondary|Cumulative Summary of Participants With HBV Genotypic Changes From Baseline (Resistance Surveillance)|Resistance surveillance was conducted annually for all participants who remained on treatment and had HBV DNA concentrations greater than or equal to the level of detection (>= 169 copies/mL) by PCR. The last on-ADV sample for all participants in the study was analyzed in the cumulative Week 240 resistance surveillance analysis.|240 weeks|Last on-ADV sample through Week 240 was analyzed, and participant was excluded from the cumulative Week 240 analysis if HBV DNA value was < 169 copies/mL at Week 240/last time point or if participant discontinued study drug but remained in study. One ADV-ADV participant had an ADV-specific, conserved-site mutation and is counted twice in the table.||Participants|||Number
703465|NCT00095121|Secondary|Percentage of Participants With HBeAg Loss or Seroconversion by ADV Week 240 (Open Label Analysis Set, Participants Who Were HBeAg Positive at ADV Baseline; Missing = Excluded)|Per protocol, participants could discontinue study medication due to HBeAg seroconversion and remain in the study in order to evaluate the durability of seroconversion. HBeAg loss is defined for an individual participant as HBeAg+ at ADV baseline and HBeAg− post baseline. HBeAg seroconversion is defined for an individual participant as HBeAg+ at ADV baseline and HBeAg− and anti-HBe+ post baseline.|ADV baseline to ADV Week 240|The OL analysis set included any participant who took at least one dose of open-label ADV. This analysis set was subdivided based on DB drug, as ADV-ADV or PLB-ADV. Participants with missing values were excluded. Analysis set included only data from participants while on study treatment.||percentage of participants|||Number
703466|NCT00095121|Secondary|Percentage of Participants With HBeAg Loss or Seroconversion by ADV Week 192 (Open Label Analysis Set, Participants Who Were HBeAg Positive at ADV Baseline; Missing = Excluded)|ADV baseline = 1st ADV-dose day = Week 0 for ADV-ADV group and Week 48 for PLB-ADV group. ADV week = windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240), whereas participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192). HBeAg loss is defined per individual participant as HBeAg+ at ADV baseline and HBeAg− post baseline. HBeAg seroconversion is defined for an individual participant as HBeAg+ at ADV baseline and HBeAg− and anti-HBe+ post baseline.|ADV baseline to ADV Week 192|The OL analysis set included any participant who took at least one dose of open-label ADV. This analysis set was subdivided based on DB drug, as ADV-ADV or PLB-ADV. Participants with missing values were excluded. Analysis set included only data from participants while on study treatment.||percentage of participants|||Number
703467|NCT00095121|Secondary|Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss or Seroconversion by End of Blinded Treatment (Study Week 48; Randomized and Treated Analysis Set)|HBeAg loss is defined for an individual participant as HBeAg+ at ADV baseline and HBeAg− post baseline. HBeAg seroconversion is defined for an individual participant as HBeAg+ at ADV baseline and HBeAg− and hepatitis B e antibody + (anti-HBe+) post baseline.|Study Week 0 to Study Week 48 (double-blind period)|The randomized and treated analysis set included all participants who were randomized into the study and received at least one dose of study medication. For Week 48 data; if Week 48 was missing, Week 44 was carried forward; if Week 44 was missing, missing = failure.||percentage of participants|||Number
703468|NCT00095121|Secondary|Percentage of Participants With Normal ALT at ADV Week 240 (Missing = Failure)|Normal ALT: 0-1 year old = <=54 U/L; females 1-88 years old and males 1-10 years old = 8-34 U/L; males 10-88 years old = 8-43 U/L.|ADV Week 240|The OL analysis set included any participant who took at least one dose of open-label ADV. This analysis set was subdivided based on DB drug, as ADV-ADV or PLB-ADV. Participants with missing values were considered as failures rather than excluded. Analysis set included only data from participants while on study treatment.||percentage of participants|||Number
703469|NCT00095121|Secondary|Percentage of Participants With Normal ALT at ADV Week 192 (Missing = Failure)|Adefovir week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240), whereas participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192). Normal ALT: 0-1 year old = <=54 U/L; females 1-88 years old and males 1-10 years old = 8-34 U/L; males 10-88 years old = 8-43 U/L.|ADV Week 192|The OL analysis set included any participant who took at least one dose of open-label ADV. This analysis set was subdivided based on DB drug, as ADV-ADV or PLB-ADV. Participants with missing values were considered as failures rather than excluded. Analysis set included only data from participants while on study treatment.||percentage of participants|||Number
703470|NCT00095121|Secondary|Percentage of Participants With Normal ALT at Adefovir Baseline (Missing = Failure)|The ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group] and Week 48 for those originally randomized to placebo [PLB-ADV group]). Normal ALT: 0-1 year old = <=54 U/L; females 1-88 years old and males 1-10 years old = 8-34 U/L; males 10-88 years old = 8-43 U/L.|ADV baseline|The OL analysis set included any participant who took at least one dose of open-label ADV. This analysis set was also subdivided based on DB drug, as ADV-ADV or PLB-ADV. Participants with missing values were considered as failures rather than excluded. Analysis set included only data from participants while on study treatment.||percentage of participants|||Number
703471|NCT00095121|Secondary|Change From ADV Baseline to ADV Week 240 for ALT||ADV baseline to ADV 240 weeks|The OL analysis set included any participant who took at least one dose of open-label ADV. This analysis set was also subdivided based on DB drug, as ADV-ADV or PLB-ADV. Analysis set included only data from participants while on study treatment.||U/L||Standard Deviation|Mean
703612|NCT00095303|Secondary|Main Study, Risky Sexual Behaviors at Baseline|For the Main Study, the total score of the ‘HIV/Sex Risk Behaviors’ measure was used as the outcome. Scores ranged from -0.5 to 8.7. The higher the score, the more risky sexual behavior.|Baseline|||units on a scale||Standard Error|Least Squares Mean
703472|NCT00095121|Secondary|Change From ADV Baseline to ADV Week 192 for ALT|Adefovir week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240), whereas participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).|ADV baseline to ADV 192 weeks|The OL analysis set included any participant who took at least one dose of open-label ADV. This analysis set was subdivided based on DB drug, as ADV-ADV or PLB-ADV. Analysis set included only data from participants while on study treatment.||U/L||Standard Deviation|Mean
703473|NCT00095121|Secondary|ADV Baseline ALT|The ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group] and Week 48 for those originally randomized to placebo [PLB-ADV group]).|ADV baseline|The OL analysis set included any participant who took at least one dose of open-label ADV. This analysis set was also subdivided based on DB drug, as ADV-ADV or PLB-ADV. Analysis set included only data from participants while on study treatment.||U/L||Standard Deviation|Mean
703474|NCT00095121|Secondary|Change From ADV Baseline to ADV Week 240 for Serum HBV DNA||ADV baseline to ADV 240 weeks|The OL analysis set included any participant who took at least one dose of open-label ADV. This analysis set was also subdivided based on DB drug, as ADV-ADV or PLB-ADV. Analysis set included only data from participants while on study treatment.||log10 HBV DNA copies/mL||Standard Deviation|Mean
703475|NCT00095121|Secondary|Change From ADV Baseline to ADV Week 192 for Serum HBV DNA|Adefovir week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240), whereas participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).|ADV baseline to ADV 192 weeks|The OL analysis set included any participant who took at least one dose of open-label ADV. This analysis set was subdivided based on DB drug, as ADV-ADV or PLB-ADV. Analysis set included only data from participants while on study treatment.||log10 HBV DNA copies/mL||Standard Deviation|Mean
703476|NCT00095121|Secondary|Adefovir (ADV) Baseline Serum HBV DNA|The ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group] and Week 48 for those originally randomized to placebo [PLB-ADV group]).|ADV baseline|The OL analysis set included any participant who took at least one dose of open-label ADV. This analysis set was also subdivided based on DB drug, as ADV-ADV or PLB-ADV. Analysis set included only data from participants while on study treatment.||log10 HBV DNA copies/mL||Standard Deviation|Mean
703477|NCT00095121|Secondary|Percentage of Participants With Serum HBV DNA < 400 Copies/mL (PCR-based Assay) While on Treatment (Missing = Failure) (ADV Week 240)||ADV Week 240|The OL analysis set was used for this endpoint and included any participant who took at least 1 dose of open-label ADV. Participants with missing values were considered as failures rather than excluded.||percentage of participants|||Number
703478|NCT00095121|Secondary|Percentage of Participants With Serum HBV DNA < 400 Copies/mL (PCR-based Assay) While on Treatment (Missing = Failure) (ADV Week 192)|Adefovir week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240), whereas participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).|ADV Week 192|The OL analysis set was used for this endpoint and included any participant who took at least 1 dose of open-label ADV. Participants with missing values were considered as failures rather than excluded.||percentage of participants|||Number
703479|NCT00095121|Secondary|Percentage of Participants With Serum HBV DNA < 400 Copies/mL (PCR-based Assay) While on Treatment (Missing = Failure) (ADV Baseline)|The ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group] and Week 48 for those originally randomized to placebo [PLB-ADV group]).|ADV baseline|The OL analysis set was used for this endpoint and included any participant who took at least 1 dose of open-label ADV. Participants with missing values were considered as failures rather than excluded.||percentage of participants|||Number
703480|NCT00095121|Secondary|Percentage of Participants With Serum HBV DNA < 1000 Copies/mL (PCR-based Assay) While on Treatment (Missing = Failure) (ADV Week 240)||ADV Week 240|The OL analysis set was used for this endpoint and included any participant who took at least 1 dose of open-label ADV. Participants with missing values were considered as failures rather than excluded.||percentage of participants|||Number
703481|NCT00095121|Secondary|Percentage of Participants With Serum HBV DNA < 1000 Copies/mL (PCR-based Assay) While on Treatment - Missing = Failure) (ADV Week 192)|Adefovir week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240), whereas participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).|ADV Week 192|The OL analysis set was used for this endpoint and included any participant who took at least 1 dose of open-label ADV. Participants with missing values were considered as failures rather than excluded.||percentage of participants|||Number
703482|NCT00095121|Secondary|Percentage of Participants With Serum HBV DNA < 1000 Copies/mL (PCR-based Assay) While on Treatment (Missing = Failure) (ADV Baseline)|The ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group] and Week 48 for those originally randomized to placebo [PLB-ADV group]).|ADV baseline|The OL analysis set was used for this endpoint and included any participant who took at least 1 dose of open-label ADV. Participants with missing values were considered as failures rather than excluded.||percentage of participants|||Number
703483|NCT00095121|Primary|Percentage of Participants With Serum Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) < 1000 Copies/mL (Polymerase Chain Reaction [PCR]-Based Assay) and Normal Alanine Aminotransferase (ALT) at Week 48 (Missing = Failure)|In the absence of biopsy data from these pediatric participants, this endpoint enables assessments of drug effect on viral replication and the underlying degree of inflammation in the liver.|Week 48|All randomized participants who received >= 1 dose study medication. If either endpoint was missing a Week 48 value, Week 44 value was substituted and used in the combined endpoint. If participant did not have serum HBV DNA value at Weeks 44 and 48 or ALT value at Weeks 44 and 48, then participant was considered a failure for the Week-48 analysis.||percentage of participants|||Number
703679|NCT00095498|Secondary|Change From Baseline in Basophils at Month 1|Laboratory hematology basophils|baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.||*10^9/L||Standard Deviation|Mean
703484|NCT00095147|Primary|OL; Mean Temperature (T) During Open Label Period|Temperature (T), units=degrees Celcius|Days 365, 729, 1121, and 1513|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period.n=number of participants with data available.||degrees Celsius||Standard Deviation|Mean
703485|NCT00095147|Primary|OL; Mean Heart Rate (HR) During Open Label Period|Heart Rate (HR), units=beats per minute (bpm)|Days 365, 729, 1121, and 1513|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period.n=number of participants with data available.||beats per minute (bpm)||Standard Deviation|Mean
703486|NCT00095147|Primary|OL; Mean Systolic (SBP) and Diastolic (DBP) Blood Pressure During Open Label Period|Seated Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), units=mm mercury (Hg)|Days 365, 729, 1121, and 1513|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period.n=number of participants with data available.||mm mercury (Hg)||Standard Deviation|Mean
703487|NCT00095147|Primary|OL; Mean Change From Baseline to Day 1513 in Alanine Aminotransferase, Aspartate Aminotransferase, G-Glutamyl Transferase, and Alkaline Phosphatase|alanine aminotransferase (ALT): >3 x ULN; aspartate aminotransferase (AST): >3 x ULN; G-Glutamyl transferase (GGT): >2 x ULN; Alkaline phosphatase (ALP): >2 x ULN|Baseline (Day 1), Day 1513|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.||U/L||Standard Error|Mean
703488|NCT00095147|Primary|OL; Mean Change From Baseline to Day 1513 in Bilirubin, Blood Urea Nitrogen, Creatinine, Calcium, Phosphorous, Serum Glucose, Fasting Serum Glucose, and Uric Acid|Bilirubin: >2 x ULN; blood urea nitrogen (BUN): >2 x BL; creatinine: >4 x BL; calcium (Ca): <0.8 x LLN, >1.2 x ULN; phosphorous (P): <0.75 x LLN, >1.2 5 x ULN; serum glucose (Glu): <65 mg/dL, >220 mg/dL; fasting serum Glu: <0.8 x LLN, >1.5 x ULN; uric acid: >1.5 x ULN;|Baseline (Day 1), Day 1513|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.||mg/dL||Standard Error|Mean
703489|NCT00095147|Primary|OL; Mean Change From Baseline to Day 1513 in Electrolytes|Sodium (Na): <0.95 x LLN, >1.05 x ULN; potassium (K): <0.9 x LLN, >1.1 x ULN; chloride (Cl): <0.9 x LLN, >1.1 x ULN|Baseline (Day 1), Day 1513|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.||mEq/L||Standard Error|Mean
703490|NCT00095147|Primary|OL; Mean Change From Baseline to Day 1513 in Erythrocytes|Erythrocytes: <0.75 x BL|Baseline (Day 1), Day 1513|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.||10^6 c/uL||Standard Error|Mean
703491|NCT00095147|Primary|OL; Mean Change From Baseline to Day 1513 in White Blood Cells|Leukocytes: <0.75 x LLN, >1.25 x ULN; neutrophils+bands: <1.0 x 10^3 c/uL; eosinophils: >0.750 x 10^3 c/uL; basophils: > 400 mm3; monocytes: >2000 mm3; lymphocytes: <0.750 x 10^3 c/uL, >7.50 x 10^3 c/uL.|Baseline (Day 1), Day 1513|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.||10^3 c/uL||Standard Error|Mean
703492|NCT00095147|Primary|OL; Mean Change From Baseline to Day 1513 in Hematocrit|Hematocrit: <0.75 x BL|Baseline (Day 1), Day 1513|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.||percentage of red blood cells||Standard Error|Mean
703493|NCT00095147|Primary|OL; Mean Change From Baseline to Day 1513 in Platelets|Platelets (PLT): <0.67 x LLN, >1.5 x ULN|Baseline (Day 1), Day 1513|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.||10^9 c/L||Standard Error|Mean
703494|NCT00095147|Primary|OL; Mean Change From Baseline to Day 1513 in Hemoglobin, Total Protein, and Albumin|Hemoglobin (HGB): >3 g/dL decrease from BL; total protein: < 0.9 x LLN, >1.1 x ULN; albumin:<0.9 x LLN|Baseline (Day 1), Day 1513|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.||g/dL||Standard Error|Mean
703495|NCT00095147|Primary|OL; Mean Change From Baseline to Day 1121 in Alanine Aminotransferase, Aspartate Aminotransferase, G-Glutamyl Transferase, and Alkaline Phosphatase|alanine aminotransferase (ALT): >3 x ULN; aspartate aminotransferase (AST): >3 x ULN; G-Glutamyl transferase (GGT): >2 x ULN; Alkaline phosphatase (ALP): >2 x ULN|Baseline (Day 1), Day 1121|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.||U/L||Standard Error|Mean
703496|NCT00095147|Primary|OL; Mean Change From Baseline to Day 1121 in Bilirubin, Blood Urea Nitrogen, Creatinine, Calcium, Phosphorous, Serum Glucose, Fasting Serum Glucose, and Uric Acid|Bilirubin: >2 x ULN; blood urea nitrogen (BUN): >2 x BL; creatinine: >4 x BL; calcium (Ca): <0.8 x LLN, >1.2 x ULN; phosphorous (P): <0.75 x LLN, >1.2 5 x ULN; serum glucose (Glu): <65 mg/dL, >220 mg/dL; fasting serum Glu: <0.8 x LLN, >1.5 x ULN; uric acid: >1.5 x ULN;|Baseline (Day 1), Day 1121|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.||mg/dL||Standard Error|Mean
703497|NCT00095147|Primary|OL; Mean Change From Baseline to Day 1121 in Electrolytes|Sodium (Na): <0.95 x LLN, >1.05 x ULN; potassium (K): <0.9 x LLN, >1.1 x ULN; chloride (Cl): <0.9 x LLN, >1.1 x ULN|Baseline (Day 1), Day 1121|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.||mEq/L||Standard Error|Mean
703498|NCT00095147|Primary|OL; Mean Change From Baseline to Day 1121 in Erythrocytes|Erythrocytes: <0.75 x BL|Baseline (Day 1), Day 1121|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.||10^6 c/uL||Standard Error|Mean
703499|NCT00095147|Primary|OL; Mean Change From Baseline to Day 1121 in White Blood Cells|Leukocytes: <0.75 x LLN, >1.25 x ULN; neutrophils+bands: <1.0 x 10^3 c/uL; eosinophils: >0.750 x 10^3 c/uL; basophils: > 400 mm3; monocytes: >2000 mm3; lymphocytes: <0.750 x 10^3 c/uL, >7.50 x 10^3 c/uL.|Baseline (Day 1), Day 1121|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.||10^3 c/uL||Standard Error|Mean
703500|NCT00095147|Primary|OL; Mean Change From Baseline to Day 1121 in Hematocrit|Hematocrit: <0.75 x BL|Baseline (Day 1), Day 1121|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.||percentage of red blood cells||Standard Error|Mean
703501|NCT00095147|Primary|OL; Mean Change From Baseline to Day 1121 in Platelets|Platelets (PLT): <0.67 x LLN, >1.5 x ULN|Baseline (Day 1), Day 1121|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.||10^9 c/L||Standard Error|Mean
703502|NCT00095147|Primary|OL; Mean Change From Baseline to Day 1121 in Hemoglobin, Total Protein, and Albumin|Hemoglobin (HGB): >3 g/dL decrease from BL; total protein: < 0.9 x LLN, >1.1 x ULN; albumin:<0.9 x LLN|Baseline (Day 1), Day 1121|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.||g/dL||Standard Error|Mean
703503|NCT00095147|Primary|OL; Mean Change From Baseline to Day 729 in Alanine Aminotransferase, Aspartate Aminotransferase, G-Glutamyl Transferase, and Alkaline Phosphatase|alanine aminotransferase (ALT): >3 x ULN; aspartate aminotransferase (AST): >3 x ULN; G-Glutamyl transferase (GGT): >2 x ULN; Alkaline phosphatase (ALP): >2 x ULN|Baseline (Day 1), Day 729|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.||U/L||Standard Error|Mean
703504|NCT00095147|Primary|OL; Mean Change From Baseline to Day 729 in Bilirubin, Blood Urea Nitrogen, Creatinine, Calcium, Phosphorous, Serum Glucose, Fasting Serum Glucose, and Uric Acid|Bilirubin: >2 x ULN; blood urea nitrogen (BUN): >2 x BL; creatinine: >4 x BL; calcium (Ca): <0.8 x LLN, >1.2 x ULN; phosphorous (P): <0.75 x LLN, >1.2 5 x ULN; serum glucose (Glu): <65 mg/dL, >220 mg/dL; fasting serum Glu: <0.8 x LLN, >1.5 x ULN; uric acid: >1.5 x ULN;|Baseline (Day 1), Day 729|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.||mg/dL||Standard Error|Mean
703505|NCT00095147|Primary|OL; Mean Change From Baseline to Day 729 in Electrolytes|Sodium (Na): <0.95 x LLN, >1.05 x ULN; potassium (K): <0.9 x LLN, >1.1 x ULN; chloride (Cl): <0.9 x LLN, >1.1 x ULN|Baseline (Day 1), Day 729|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.||mEq/L||Standard Error|Mean
703506|NCT00095147|Primary|OL; Mean Change From Baseline to Day 729 in Erythrocytes|Erythrocytes: <0.75 x BL|Baseline (Day 1), Day 729|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.||10^6 c/uL||Standard Error|Mean
703507|NCT00095147|Primary|OL; Mean Change From Baseline to Day 729 in White Blood Cells|Leukocytes: <0.75 x LLN, >1.25 x ULN; neutrophils+bands: <1.0 x 10^3 c/uL; eosinophils: >0.750 x 10^3 c/uL; basophils: > 400 mm3; monocytes: >2000 mm3; lymphocytes: <0.750 x 10^3 c/uL, >7.50 x 10^3 c/uL.|Baseline (Day 1), Day 729|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.||10^3 c/uL||Standard Error|Mean
703508|NCT00095147|Secondary|OL; Adjusted Mean Change From Baseline to Day 729 in HAQ-DI|The disability section of the full HAQ includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Higher scores= greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ disability Index.|Day 1 (Baseline), Day 729|All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period.||units on a scale||Standard Error|Mean
703613|NCT00095303|Secondary|Follow Up Study, Level of Family Functioning|For the follow up study, family functioning was measured by a composite of the Cohesion and Conflict scales of the Family Environment Scale. Scores ranged from 1.0 to 18.0. The higher the value, the better the level of family functioning outcome.|90 days prior assessment|||units on a scale||Standard Deviation|Mean
703509|NCT00095147|Secondary|OL; Percentage of Participants With Clinically Meaningful Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Over Time|The disability section of the full HAQ includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Higher scores= greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ disability Index.|OL Days 197, 253, 281, 309, 337, 365, 449, 533, 617, and 729|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period.n=number of participants with data available.||percentage of participants|||Number
703510|NCT00095147|Secondary|OL; Percentage of Participants Who Achieved Major Clinical Response|Major Clinical Response was defined as a continuous ACR 70 for six months.|Defined from the date of achieving ACR 70 response to 6 months post response|Protocol-specified analyses of the proportion of participants achieving a Major Clinical Response were not performed since ACR responses in the open-label period could only be assessed at 6-month intervals due to the fact that CRP and ESR were only measured every 6 months during this period.|||||
703511|NCT00095147|Secondary|OL; Percentage of Participants With American College of Rheumatology (ACR) Responses Over Time|The ACR 20 definition of improvement is a 20% improvement from baseline in the number of tender and swollen joint counts, and a 20% improvement from baseline in 3 of the remaining 5 core set measures: participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function and acute phase reactant value (C-reactive protein [CRP]). The evaluation for 50% improvement (ACR 50) and 70% improvement (ACR 70) follow similarly.|DB Day 197, Day 365, Day 533, Day 729|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.||percentage of participants|||Number
703512|NCT00095147|Secondary|OL; Percentage of Participants With Good, Moderate, or No Response According to European League Against Rheumatism (EULAR) Over Time|The DAS28 is a continuous disease measure composite of 4 variables: 28 tender joint count, 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. High disease activity= > 5.1, low disease activity= < 3.2, and remission= < 2.6. Clinically significant response= decrease of >1.2 from baseline. Utilizing EULAR response criteria, DAS28 categorical responses define a good (absolute <3.2 or >1.2 improvement from baseline [BL]), moderate (absolute 3.2-5.1 or 0.6-1.2 change from BL), or no response (absolute >5.1 or <0.6 change from BL)|DB Days 365, 533, and 729|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period.n=number of participants with data available.||percentage of participants|||Number
703513|NCT00095147|Secondary|OL; Percentage of Participants With DAS28 (ESR) Remission and Low Disease Activity (LDAS) Over Time|The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). A clinically significant response is a decrease in DAS28 score of >1.2 from baseline.|Baseline (Day 1), Day 365, Day 533, Day 729|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Efficacy data was summarized for the 3 DB treatment cohorts.n=number of participants with data available.||percentage of participants|||Number
703514|NCT00095147|Secondary|OL; Mean Change From Baseline Over Time in DAS 28 (ESR) Score|The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). A clinically significant response is a decrease in DAS28 score of >1.2 from baseline.|Baseline (Day 1), Day 365, Day 533, Day 729|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period.n=number of participants with data available.||units on a scale||Standard Error|Mean
703515|NCT00095147|Primary|OL; Mean Change From Baseline to Day 729 in Hematocrit|Hematocrit: <0.75 x BL|Baseline (Day 1), Day 729|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.||percentage of red blood cells||Standard Error|Mean
703516|NCT00095147|Primary|OL; Mean Change From Baseline to Day 729 in Platelets|Platelets (PLT): <0.67 x LLN, >1.5 x ULN|Baseline (Day 1), Day 729|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.||10^9 c/L||Standard Error|Mean
703517|NCT00095147|Primary|OL; Mean Change From Baseline to Day 729 in Hemoglobin, Total Protein, and Albumin|Hemoglobin (HGB): >3 g/dL decrease from BL; total protein: < 0.9 x LLN, >1.1 x ULN; albumin:<0.9 x LLN|Baseline (Day 1), Day 729|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.||g/dL||Standard Error|Mean
703659|NCT00095498|Secondary|Change From Baseline in Monocytes at Month 1|Laboratory hematology monocytes|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.||* 10^9/L||Standard Deviation|Mean
703660|NCT00095498|Secondary|Change From Baseline in Lymphocytes at Month 12|Laboratory hematology lymphocytes|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.||* 10^9/L||Standard Deviation|Mean
703518|NCT00095147|Primary|OL; Mean Change From Baseline to Day 365 in Alanine Aminotransferase, Aspartate Aminotransferase, G-Glutamyl Transferase, and Alkaline Phosphatase|alanine aminotransferase (ALT): >3 x ULN; aspartate aminotransferase (AST): >3 x ULN; G-Glutamyl transferase (GGT): >2 x ULN; Alkaline phosphatase (ALP): >2 x ULN|Baseline (Day 1), Day 365|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.||U/L||Standard Error|Mean
703519|NCT00095147|Primary|OL; Mean Change From Baseline to Day 365 in Bilirubin, Blood Urea Nitrogen, Creatinine, Calcium, Phosphorous, Serum Glucose, Fasting Serum Glucose, and Uric Acid|Bilirubin: >2 x ULN; blood urea nitrogen (BUN): >2 x BL; creatinine: >4 x BL; calcium (Ca): <0.8 x LLN, >1.2 x ULN; phosphorous (P): <0.75 x LLN, >1.2 5 x ULN; serum glucose (Glu): <65 mg/dL, >220 mg/dL; fasting serum Glu: <0.8 x LLN, >1.5 x ULN; uric acid: >1.5 x ULN;|Baseline (Day 1), Day 365|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.||mg/dL||Standard Error|Mean
703520|NCT00095147|Primary|OL; Mean Change From Baseline to Day 365 in Electrolytes|Sodium (Na): <0.95 x LLN, >1.05 x ULN; potassium (K): <0.9 x LLN, >1.1 x ULN; chloride (Cl): <0.9 x LLN, >1.1 x ULN|Baseline (Day 1), Day 365|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.||mEq/L||Standard Error|Mean
703521|NCT00095147|Primary|OL; Mean Change From Baseline to Day 365 in Erythrocytes|Erythrocytes: <0.75 x BL|Baseline (Day 1), Day 365|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.||10^6 c/uL||Standard Error|Mean
703522|NCT00095147|Primary|OL; Mean Change From Baseline to Day 365 in White Blood Cells|Leukocytes: <0.75 x LLN, >1.25 x ULN; neutrophils+bands: <1.0 x 10^3 c/uL; eosinophils: >0.750 x 10^3 c/uL; basophils: > 400 mm3; monocytes: >2000 mm3; lymphocytes: <0.750 x 10^3 c/uL, >7.50 x 10^3 c/uL.|Baseline (Day 1), Day 365|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.||10^3 c/uL||Standard Error|Mean
703523|NCT00095147|Primary|OL; Mean Change From Baseline to Day 365 in Hematocrit|Hematocrit: <0.75 x BL|Baseline (Day 1), Day 365|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.||percentage red blood cells||Standard Error|Mean
703524|NCT00095147|Primary|OL; Mean Change From Baseline to Day 365 in Platelets|Platelets (PLT): <0.67 x LLN, >1.5 x ULN|Baseline (Day 1), Day 365|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.||10^9 c/L||Standard Error|Mean
703525|NCT00095147|Primary|OL; Mean Change From Baseline to Day 365 in Hemoglobin, Total Protein, and Albumin|Hemoglobin (HGB): >3 g/dL decrease from BL; total protein: < 0.9 x LLN, >1.1 x ULN; albumin:<0.9 x LLN|Baseline (Day 1), Day 365|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.||g/dL||Standard Error|Mean
703526|NCT00095147|Secondary|DB; Percentage of Participants With Antibodies Against Infliximab (Human Anti-chimeric Antibody [HACA]) From Day 1 Through Day 365|Infliximab levels were measured using a microplate enzyme-linked immunosorbant assay (ELISA) with infliximab bound to immobilized recombinant tumor necrosis factor (TNF)-alpha. Bound infliximab is detected utilizing a horseradish peroxidase-conjugated anti-human IgG Fc(fragment, crystallizable region)-specific). The enzyme turns over the substrate O-phenlenediamine to a chromogenic product that is measured at 490 nm. The cut-off value was 1.40 ug/mL; this was based on the mean (+ 3 SD) value in serum samples from 40 participants who had never received infliximab.|Day 1 through day 365|The immunogenicity analysis population included participants who received at least one dose of infliximab and had immunogenicity samples collected at baseline and at least one post-baseline treatment visit.||percentage of participants|||Number
703527|NCT00095147|Secondary|DB; Number of Participants With Anti-Abatacept Antibodies From Day 1 Through Day 365 (Electrochemiluminescent [ECL] Immunoassay)|ECL screened sera for drug-specific antibodies, immunocompetition was used to identify specific anti-Abatacept reactivity. Cytotoxic leukocyte antigen 4 (CTLA4) and Possibly Immunoglobulin (Ig) Category=reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction Category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing.|Day 1 through day 365|The immunogenicity analysis population included participants who received at least one dose of abatacept and had immunogenicity samples collected at baseline and at least one post-baseline treatment visit.||participants|||Number
703528|NCT00095147|Secondary|DB; Number of Participants With Select Hematologic and Blood Chemistry Laboratory Abnormalities on Days 1 Through 365|High=greater than Upper Normal Limit (ULN), Low=lower than Lower Normal Limit (LLN). LLN/ULN= Hemoglobin (HGB): >3 g/dL decrease from Baseline (BL); Hematocrit: <0.75 x BL; Platelets (PLT): <0.67 x LLN/>1.5 x ULN; Leukocytes: <0.75 x LLN/ >1.25 x ULN; neutrophils+bands: <1.0 x 10^3 c/uL; aspartate aminotransferase (AST): >3 x ULN; alanine aminotransferase (ALT): >3 x ULN; creatinine: >4 x BL|From Baseline (Day 1) through Day 365, and up to 56 days after last dose if occurring on-study|The As-Treated analysis population contained all participants who received at least one dose of double-blind study medication, and participants were grouped on an as-assigned or randomized basis unless the participant received the incorrect medication for the entire period of treatment.||participants|||Number
703529|NCT00095147|Secondary|DB; Number of Participants With Select Hematologic and Blood Chemistry Laboratory Abnormalities on Days 1 Through 197|High=greater than Upper Normal Limit (ULN), Low=lower than Lower Normal Limit (LLN). LLN/ULN= Hemoglobin (HGB): >3 g/dL decrease from Baseline (BL); Hematocrit: <0.75 x BL; Platelets (PLT): <0.67 x LLN/>1.5 x ULN; Leukocytes: <0.75 x LLN/ >1.25 x ULN; neutrophils+bands: <1.0 x 10^3 c/uL; aspartate aminotransferase (AST): >3 x ULN; alanine aminotransferase (ALT): >3 x ULN; creatinine: >4 x BL|From Baseline (Day 1) through Day 197, and up to 56 days after last dose if occurring on-study|The As-Treated analysis population contained all participants who received at least one dose of double-blind study medication, and participants were grouped on an as-assigned or randomized basis unless the participant received the incorrect medication for the entire period of treatment.||participants|||Number
703530|NCT00095147|Secondary|DB; Number of Participants With Significant Changes in Mean Temperature During Days 1 Through 197 and Days 1 Through 365|Temperature (T) was assessed as clinically significant or relevant at the discretion of the Clinical Investigator. Criteria may have varied between institutions.|From Baseline (Day 1) through Day 197, and up to 56 days after last dose if occurring on-study|As Treated Population.||participants|||Number
703531|NCT00095147|Secondary|DB; Number of Participants With Significant Changes in Mean Heart Rate During Days 1 Through 197 and Days 1 Through 365|Heart Rate (HR) was assessed as clinically significant or relevant at the discretion of the Clinical Investigator. Criteria may have varied between institutions.|From Baseline (Day 1) through Day 197, or Day 1 through Day 365, and up to 56 days after last dose if occurring on-study|As Treated Population.||participants|||Number
703532|NCT00095147|Secondary|DB; Number of Participants With Significant Changes in Mean Systolic and Diastolic Blood Pressure During Days 1 Through 197 and Days 1 Through 365|Seated Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) were assessed as clinically significant or relevant at the discretion of the Clinical Investigator. Criteria may have varied between institutions.|From Baseline (Day 1) through Day 197, or Day 1 through Day 365, and up to 56 days after last dose if occurring on-study|As-Treated Population||participants|||Number
703533|NCT00095147|Secondary|DB; Number of Participants With AEs of Special Interest From Day 198 Through Day 365 in Participants Receiving Placebo Switched to Abatacept|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, autoimmune disorders; malignancies; and acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion).|From Day 198 through Day 365, and up to 56 days after last dose if occurring on-study|The As-Treated analysis population contained all participants who received at least one dose of double-blind study medication, and participants were grouped on an as-assigned or randomized basis unless the participant received the incorrect medication for the entire period of treatment.||participants|||Number
703534|NCT00095147|Secondary|DB; Number of Participants With AEs of Special Interest From Day 1 Through Day 365|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, autoimmune disorders; malignancies; and acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion).|From Baseline (Day 1) through Day 365, and up to 56 days after last dose if occurring on-study|The As-Treated analysis population contained all participants who received at least one dose of double-blind study medication, and participants were grouped on an as-assigned or randomized basis unless the participant received the incorrect medication for the entire period of treatment.||participants|||Number
703535|NCT00095147|Primary|OL; Number of Participants With Select Blood Chemistry Laboratory Abnormalities|Low=lower than LLN, High=greater than ULN. LLN/ULN= Alkaline phosphatase (ALP): >2 x ULN; aspartate aminotransferase (AST): >3 x ULN; alanine aminotransferase (ALT): >3 x ULN; G-Glutamyl transferase (GGT): >2 x ULN; Bilirubin: >2 x ULN; blood urea nitrogen (BUN): >2 x BL; creatinine: >4 x BL|From Day 366 through end of OL (range from 1.9 months to 42.3 months)|All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period.||participants|||Number
703536|NCT00095147|Primary|OL; Number of Participants With Select Hematologic Laboratory Abnormalities|High=greater than Upper Normal Limit (ULN), Low=lower than Lower Normal Limit (LLN). LLN/ULN= Hemoglobin (HGB): >3 g/dL decrease from Baseline (BL); Hematocrit: <0.75 x BL; Erythrocytes: <0.75 x BL; Platelets (PLT): <0.67 x LLN/>1.5 x ULN; Leukocytes: <0.75 x LLN/ >1.25 x ULN; neutrophils+bands: <1.0 x 10^3 c/uL; lymphocytes: <0.750 x 10^3 c/uL/ >7.50 x 10^3 c/uL; monocytes: >2000 mm3; eosinophils: >0.750 x 10^3 c/uL;|From Day 366 through end of OL (range from 1.9 months to 42.3 months)|All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period.||participants|||Number
703537|NCT00095147|Primary|OL; Number of Participants With AEs of Special Interest|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, autoimmune disorders; malignancies; and acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion).|From beginning of OL (Day 366) through end of OL (range from 1.9 months to 42.3 months)|All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period.||participants|||Number
703538|NCT00095147|Primary|OL; Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Related AEs, and AEs Leading to Discontinuation|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|From beginning of OL (Day 366) through end of OL (range from 1.9 months to 42.3 months)|All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period.||participants|||Number
703539|NCT00095147|Secondary|DB; Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, and AEs Leading to Discontinuation From Day 198 Through Day 365 in Participants Receiving Placebo Switched to Abatacept|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|From Day 198 through Day 365, and up to 56 days after last dose if occurring on-study|The As-Treated analysis population contained all participants who received at least one dose of double-blind study medication, and participants were grouped on an as-assigned or randomized basis unless the participant received the incorrect medication for the entire period of treatment.||participants|||Number
703540|NCT00095147|Secondary|DB; Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, and AEs Leading to Discontinuation From Day 1 Through Day 365|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|From Baseline (Day 1) through Day 365, and up to 56 days after last dose if occurring on-study|The As-Treated analysis population contained all participants who received at least one dose of double-blind study medication, and participants were grouped on an as-assigned or randomized basis unless the participant received the incorrect medication for the entire period of treatment.||participants|||Number
703541|NCT00095147|Secondary|DB; Number of Participants With AEs of Special Interest From Day 1 Through Day 197|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, autoimmune disorders; malignancies; and acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion).|From Baseline (Day 1) through Day 197, and up to 56 days after last dose if occurring on-study|The As-Treated analysis population contained all participants who received at least one dose of double-blind study medication, and participants were grouped on an as-assigned or randomized basis unless the participant received the incorrect medication for the entire period of treatment.||participants|||Number
703542|NCT00095147|Secondary|DB; Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, and AEs Leading to Discontinuation From Day 1 Through Day 197|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|From Baseline (Day 1) through Day 197, and up to 56 days after last dose if occurring on-study|The As-Treated analysis population contained all participants who received at least one dose of double-blind study medication, and participants were grouped on an as-assigned or randomized basis unless the participant received the incorrect medication for the entire period of treatment.||participants|||Number
703543|NCT00095147|Secondary|DB; Percentage of Participants With American College of Rheumatology (ACR) Responses at Day 365|The ACR 20 definition of improvement is a 20% improvement from baseline in the number of tender and swollen joint counts, and a 20% improvement from baseline in 3 of the remaining 5 core set measures: participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function and acute phase reactant value (C-reactive protein [CRP]). The evaluation for 50% improvement (ACR 50) and 70% improvement (ACR 70) follow similarly.|DB Day 365|The Intent-to-Treat (ITT) analysis population was defined to include all participants randomized into the study who received study medication. Participants were grouped according to the treatment or treatment regimen to which they were randomized. All participants who were randomized but never received study medication were excluded.||percentage of participants|||Number
703544|NCT00095147|Secondary|DB; Percentage of Participants With American College of Rheumatology (ACR) Responses at Day 197|The ACR 20 definition of improvement is a 20% improvement from baseline in the number of tender and swollen joint counts, and a 20% improvement from baseline in 3 of the remaining 5 core set measures: participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function and acute phase reactant value (C-reactive protein [CRP]). The evaluation for 50% improvement (ACR 50) and 70% improvement (ACR 70) follow similarly.|DB Day 197|The Intent-to-Treat (ITT) analysis population was defined to include all participants randomized into the study who received study medication. Participants were grouped according to the treatment or treatment regimen to which they were randomized. All participants who were randomized but never received study medication were excluded.||percentage of participants|||Number
703545|NCT00095147|Secondary|DB; Percentage of Participants With Good, Moderate, or No Response According to European League Against Rheumatism (EULAR) at Day 365|The DAS28 is a continuous disease measure composite of 4 variables: 28 tender joint count, 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. High disease activity= > 5.1, low disease activity= < 3.2, and remission= < 2.6. Clinically significant response= decrease of >1.2 from baseline. Utilizing EULAR response criteria, DAS28 categorical responses define a good (absolute: <3.2 or >1.2 improvement from baseline [BL]), moderate (absolute: 3.2-5.1 or 0.6-1.2 change from BL), or no response (absolute: >5.1 or <0.6 change from BL)|DB Day 365|The Intent-to-Treat (ITT) analysis population was defined to include all participants randomized into the study who received study medication. Participants were grouped according to the treatment or treatment regimen to which they were randomized. All participants who were randomized but never received study medication were excluded.||percentage of participants|||Number
703546|NCT00095147|Secondary|DB; Adjusted Mean Change From Baseline to Day 365 in SF-36 Physical Component Summary (PCS) and Mental Component Summary (MCS)|The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.|Baseline (Day 1), 12 months (Day 365)|ITT Population: all participants randomized into the study receiving study medication, grouped according to randomization treatment. Although 3 participants in PLA group discontinued before Day 197, 2 of these patients were included in the LOCF analysis. SF-36 component scores were not presented in tabular form.||units on a scale||Standard Error|Mean
703547|NCT00095147|Secondary|DB; Adjusted Mean Change From Baseline to Day 197 in SF-36 Physical Component Summary (PCS) and Mental Component Summary (MCS)|The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.|Baseline (Day 1), 6 months (Day 197)|ITT population, all participants randomized into the study receiving study medication. Participants grouped according to the treatment to which they were randomized. All randomized participants who never received study medication were excluded. SF-36 component scores were not presented in tabular form.||units on a scale||Standard Error|Mean
703548|NCT00095147|Secondary|DB; Adjusted Mean Change From Baseline to Day 365 in HAQ-DI (LOCF Analysis)|The disability section of the full HAQ includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Higher scores= greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ disability Index.|Baseline (Day 1), 12 months (Day 365)|Intent-to-Treat (ITT) Population: all participants randomized into the study receiving study medication, grouped according to randomization treatment. All participants randomized but never receiving study medication excluded. Although 3 participants in PLA group discontinued before Day 197, 2 of these patients were included in the LOCF analysis.||units on a scale||Standard Error|Mean
703549|NCT00095147|Secondary|DB; Adjusted Mean Change From Baseline to Day 197 in HAQ-DI (LOCF Analysis)|The disability section of the full HAQ includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Higher scores= greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ disability Index.|Baseline (Day 1), 6 months (Day 197)|The Intent-to-Treat (ITT) analysis population was defined to include all participants randomized into the study who received study medication. Participants were grouped according to the treatment or treatment regimen to which they were randomized. All participants who were randomized but never received study medication were excluded.||units on a scale||Standard Error|Mean
703550|NCT00095147|Secondary|DB; Percentage of Participants With Clinically Meaningful Health Assessment Questionnaire-Disability Index (HAQ-DI) Response at Day 365|The disability section of the full HAQ includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Higher scores= greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ disability Index.|DB Day 365|The Intent-to-Treat (ITT) analysis population was defined to include all participants randomized into the study who received study medication. Participants were grouped according to the treatment or treatment regimen to which they were randomized. All participants who were randomized but never received study medication were excluded.||percentage of participants|||Number
703551|NCT00095147|Secondary|DB; Percentage of Participants With Clinically Meaningful Health Assessment Questionnaire-Disability Index (HAQ-DI) Response at Day 197|The disability section of the full HAQ includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Higher scores= greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ disability Index.|DB Day 197|The Intent-to-Treat (ITT) analysis population was defined to include all participants randomized into the study who received study medication. Participants were grouped according to the treatment or treatment regimen to which they were randomized. All participants who were randomized but never received study medication were excluded.||percentage of participants|||Number
703559|NCT00095173|Secondary|Percentage of Participants Achieving American College of Rheumatology (ACR) Pediatric 30 (ACRP30), ACR Pediatric 50, ACR Pediatric 70, ACR Pediatric 90, and Inactive Disease Status Erythrocyte Sedimentation Rate (ESR) Response Rate|The ACRP30 response criteria were defined as a ≥ 30% improvement over baseline in ESR. ACRP 50, 70, and 90 responses were defined similarly with 50%, 70%, and 90% improvements required, respectively.|Day 113, Day 282, and Day 2047|All treated participants||percentage of participants||95% Confidence Interval|Number
703661|NCT00095498|Secondary|Change From Baseline in Lymphocytes at Month 6|Laboratory hematology lymphocytes|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.||* 10^9/L||Standard Deviation|Mean
703552|NCT00095147|Secondary|DB; DAS 28 (ESR) Area Under The Curve (AUC) Over 12 Months For ABA Versus INF|The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). Clinically significant response= decrease in DAS28 score of >1.2 from baseline. DAS28 AUC can be calculated from the DAS28 score versus time curve, which provides an assessment of changes in disease activity over time.|From Day 1 through Day 365 (12 months)|The Intent-to-Treat (ITT) analysis population was defined to include all participants randomized into the study who received study medication. Participants were grouped according to the treatment or treatment regimen to which they were randomized. All participants who were randomized but never received study medication were excluded.||units on a scale||Standard Deviation|Mean
703553|NCT00095147|Secondary|DB; Adjusted Mean Change From Baseline to Day 197 in DAS 28 Score (ESR) For INF Versus PLA (LOCF Analysis)|The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). A clinically significant response is a decrease in DAS28 score of >1.2 from baseline.|Baseline (Day 1), 6 months (Day 197)|The Intent-to-Treat (ITT) analysis population was defined to include all participants randomized into the study who received study medication. Participants were grouped according to the treatment or treatment regimen to which they were randomized. All participants who were randomized but never received study medication were excluded.||units on a scale||Standard Error|Mean
703554|NCT00095147|Primary|DB; Adjusted Mean Change From Baseline to Day 197 in Disease Activity Score (DAS) 28 Score (Erythrocyte Sedimentation Rate [ESR]) For ABA Versus PLA (Last Observation Carried Forward [LOCF] Analysis)|The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or C-reactive protein (CRP), and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). A clinically significant response is a decrease in DAS28 score of >1.2 from baseline.|Baseline (Day 1), 6 months (Day 197)|The Intent-to-Treat (ITT) analysis population was defined to include all participants randomized into the study who received study medication. Participants were grouped according to the treatment or treatment regimen to which they were randomized. All participants who were randomized but never received study medication were excluded.||units on a scale||Standard Error|Mean
703555|NCT00095173|Secondary|Number of Participants With Anti-Abatacept or Anti-CTLA4 Positive Responses Over Time During Open-Label Phase (Period C)|During Period C, blood samples for immunogenicity assessments were obtained just prior to the start of the IV infusion of abatacept at 3-month intervals during the first 2 years of Period C, at 6-month intervals thereafter, and again 28, 56, and 85 days after the last infusion. Direct-format, enzyme-linked immunosorbent assays (ELISAs) were used to evaluate the cytotoxic T-lymphocyte antigen 4 (CTLA4) and the anti-CTLA4-T antibody.|Period C (Day 282 to 85 days after the last dose of study medication)|All treated participants who were evaluated for immunogenicity during Period C||participants|||Number
703556|NCT00095173|Secondary|Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)|Marked abnormalities were pre-defined as changes in lab tests after drug infusion and relative to normal range. Hemoglobin,11.6-14.8grams per deciliter(g/dL);Hematocrit,36.0-50.0 percent;Erythrocytes,3.80-5.10x10*6 cells per microliter(c/uL);Platelets,140-44 cells per liter(c/L);Leukocytes,4.00-12.50c/uL;Absolute(Abs)Neutrophils+Bands,<1.00x10^3 c/uL;Abs Lymphocytes,<0.72x10^3 or>7.50x10^3 c/uL;Abs Eosinophils,>0.750X10^3 c/uL;Alkaline Phosphatase,0-40 units per liter(U/L);Aspartate Aminotransferase,0-40 U/L;Alanine Aminotransferase,0-40U/L;G-Glutamyl Transferase,0-60 U/L;Bilirubin, 0.1-1.2 milligrams per deciliter(mg/dL);Blood Urea Nitrogen,5.9-26.0 mg/dL;Creatinine, 0.50-1.50mg/dL;Inorganic Phosphorus,2.8-6.2 U/L;Serum Potassium,3.5-5.5 milliequivalents per liter(mEq/L);Serum Glucose,65-99 mg/dL;Fasting Serum Glucose,65-99 mg/dL;Total Protein, 6.0-8.5 g/dL;Albumin,3.5-5.5 g/dL;Urine Protein,>=4;Urine Glucose,>=4;Urine Blood,>=4;Urine Red Blood Cells>=4;Urine White Blood Cells,>=4.|Period C (Day 282 to end of study)|All treated participants in Period C evaluated for a specific analyte.||participants|||Number
703557|NCT00095173|Secondary|Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)|Marked abnormalities were pre-defined as changes in lab tests that occurred after drug infusion and were reported relative to the normal range for each analyte. Hemoglobin, 11.6-14.8 grams per deciliter (g/dL);Hematocrit, 36.0-50.0 percent;Erythrocytes, 3.80-5.10x10*6 cells per microliter (c/uL);Platelets, 140-44 cells per liter (c/L);Leukocytes, 4.00-12.50 c/uL;Absolute Neutrophils + Bands, if <1.00x10^3 c/uL;Absolute Lymphocytes, if <0.72x10^3 or >7.50x10^3 c/uL;Absolute Eosinophils, if >0.750X10^3 c/uL;Aspartate Aminotransferase, 0-40 units per liter (U/L); Alanine Aminotransferase, 0-40 U/L;Blood Urea Nitrogen, 5.9-26.0 mg/dL;Serum Sodium, 135-148 milliequivalents per liter (mEq/L);Serum Potassium, 3.5-5.5 mEq/L;Serum Glucose, 65-99 mg/dL;Fasting Serum Glucose, 65-99 mg/dL;Urine Protein, >=4;Urine Blood, >=4;Urine Red Blood Cells >=4;Urine White Blood Cells, >=4.|Period B (Day 113 to Day 282)|All treated participants in Period B evaluated for a specific analyte.||participants|||Number
703558|NCT00095173|Secondary|Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Lead-In Phase (Period A)|Marked abnormalities were pre-defined as changes in lab tests that occurred after drug infusion and were reported relative to the normal range for each analyte. Hemoglobin, 11.6-14.8 grams per deciliter (g/dL);Hematocrit, 36.0-50.0 percent;Erythrocytes, 3.80-5.10x10*6 cells per microliter (c/uL);Platelets, 140-44 cells per liter (c/L);Leukocytes, 4.00-12.50 c/uL;Absolute Neutrophils + Bands, if <1.00x10^3 c/uL;Absolute Lymphocytes, if <0.72x10^3 or >7.50x10^3 c/uL;Absolute Eosinophils, if >0.750X10^3 c/uL;Alanine Aminotransferase, 0-40 units per liter (U/L);G-Glutamyl Transferase, 0-60 U/L;Bilirubin, 0.1-1.2 milligrams per deciliter (mg/dL);Blood Urea Nitrogen, 5.9-26.0 mg/dL;Creatinine, 0.50-1.50 mg/dL;Serum Potassium, 3.5-5.5 milliequivalents per liter (mEq/L);Serum Glucose, 65-99 mg/dL;Fasting Serum Glucose, 65-99 mg/dL;Total Protein, 6.0-8.5 g/dL;Albumin, 3.5-5.5 g/dL;Urine Protein, >=4;Urine Glucose, >=4;Urine Blood, >=4;Urine Red Blood Cells >=4;Urine White Blood Cells, >=4.|Period A (Day 1 to Day 113)|All treated participants in Period C evaluated for a specific analyte.||participants|||Number
703560|NCT00095173|Secondary|Events of Special Interest During Open-Label Phase (Period C), Including Infections, Peri-Infusional Adverse Events (AEs), Autoimmune Disorders and Malignancies|The sponsor prospectively identified categories of AEs that may be associated with the use of immunomodulatory drugs including infections, peri-infusional AEs, autoimmune disorders, malignancies. Peri-infusional AEs are defined as those AEs of special interest occurring during the first 24 hours after the start of study drug infusion. Malignancies definitions were based on events in the MedDRA Maintenance and Support Services Organization (MSSO) malignancies Structured MedDRA Query (SMQ).Autoimmune disorders are in alignment with the pre-specified MedDRA codes of autoimmune disorders events of interest.|Period C (Day 282 up to 56 days after the last dose of study medication)|All treated participants in Period C||participants|||Number
703561|NCT00095173|Secondary|Events of Special Interest During Double-Blind Phase (Period B), Including Infections, Peri-Infusional Adverse Events (AEs), Autoimmune Disorders and Malignancies|The sponsor prospectively identified categories of AEs that may be associated with the use of immunomodulatory drugs including infections, peri-infusional AEs, autoimmune disorders, malignancies. Peri-infusional AEs are defined as those AEs of special interest occurring during the first 24 hours after the start of study drug infusion. Malignancies definitions were based on events in the MedDRA Maintenance and Support Services Organization (MSSO) malignancies Structured MedDRA Query (SMQ).Autoimmune disorders are in alignment with the pre-specified MedDRA codes of autoimmune disorders events of interest.|Period B (Day 113 to Day 282)|All treated participants in Period B||participants|||Number
703562|NCT00095173|Secondary|Events of Special Interest During Open-Label Lead-In Phase (Period A), Including Infections, Peri-Infusional Adverse Events (AEs), Autoimmune Disorders and Malignancies|The sponsor prospectively identified categories of AEs that may be associated with the use of immunomodulatory drugs including infections, peri-infusional AEs, autoimmune disorders, malignancies. Peri-infusional AEs are defined as those AEs of special interest occurring during the first 24 hours after the start of study drug infusion. Malignancies definitions were based on events in the MedDRA Maintenance and Support Services Organization (MSSO) malignancies Structured MedDRA Query (SMQ).Autoimmune disorders are in alignment with the pre-specified MedDRA codes of autoimmune disorders events of interest.|Period A (Day 1 to Day 113)|All treated participants in Period A||participants|||Number
703563|NCT00095173|Secondary|Median Percent Change From Baseline in JRA/JIA Core Set Variables During Open-Label Phase (Period C)|Percent change from baseline was calculated from the difference between post-baseline and baseline divided by baseline multiplied by 100 and reported as the range between 25th and 75th percentile, not full range; American College of Rheumatology (ACR) Pediatric 30 JRA/JIA core set variables include active joints, limited range of motion, physician's global assessment of disease severity, parent global assessment of overall well-being, change in physical function as measured by the Childhood Health Assessment Questionnaire (CHAQ), erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP). Disease activity was assessed by the physician and parent on a 0-100 mm visual analog scale (VAS). Low values represent low severity of disease and good well-being whereas high values represent highly severe disease and very poor well-being.|Period C (Day 282 to end of study)|All treated participants in Period C||percentage change from baseline||Inter-Quartile Range|Median
703564|NCT00095173|Secondary|Median Percent Change From Baseline in JRA/JIA Core Set Variables During Double-Blind Phase (Period B)|Percent change from baseline was calculated from the difference between post-baseline and baseline divided by baseline multiplied by 100 and reported as the range between 25th and 75th percentile, not full range; American College of Rheumatology (ACR) Pediatric 30 JRA/JIA core set variables include active joints, limited range of motion, physician global assessment of disease severity, parent global assessment of overall well-being, change in physical function as measured by the Childhood Health Assessment Questionnaire (CHAQ), erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP). Disease activity was assessed by the physician and parent on a 0-100 mm visual analog scale (VAS). Low values represent low severity of disease and good well-being whereas high values represent highly severe disease and very poor well-being.|Period B (Day 113 to Day 282)|All treated participants in Period B||percentage change from baseline||Inter-Quartile Range|Median
703565|NCT00095173|Secondary|Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Open-Label Phase (Period C)|AE=any new unfavorable symptom, sign or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity or drug dependency/abuse; is life-threatening, an important medical event or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible or missing relationship to study drug. Death=during the study and up to 85 days past study discontinuation. The select AEs were determined using the Medical Dictionary for Regulatory Activities (MedDRA, v14.1).|Period C (Day 282 to end of study)|All treated participants in Period C||participants|||Number
703566|NCT00095173|Secondary|Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Double-Blind Phase (Period B)|"AE=any new unfavorable symptom, sign or disease or worsening of a preexisting condition that may not have a causal relationship with treatment.
SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity or drug dependency/abuse; is life-threatening, an important medical event or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible or missing relationship to study drug. Death=during the study and up to 28 days past study discontinuation. The select AEs were determined using the Medical Dictionary for Regulatory Activities (MedDRA, v14.1)."|Period B (Day 113 to Day 282)|All treated participants in Periods B||participants|||Number
703567|NCT00095173|Secondary|Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Open-Label Lead-In Phase (Period A)|"AE=any new unfavorable symptom, sign or disease or worsening of a preexisting condition that may not have a causal relationship with treatment.
SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity or drug dependency/abuse; is life-threatening, an important medical event or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible or missing relationship to study drug. Death=during the study and up to 28 days past study discontinuation. The select AEs were determined using the Medical Dictionary for Regulatory Activities (MedDRA, v14.1)."|Period A (Day 1 to Day 113)|All treated participants in Periods A||participants|||Number
703568|NCT00095173|Secondary|Number of Participants With a Juvenile Rheumatoid Arthritis/Juvenile Idiopathic Arthritis (JRA/JIA) Disease With a Flare During Double-Blind Phase (Period B)|"All of the following criteria must be met to be defined as a flare:
> 30% worsening in at least 3 of the 6 JRA/JIA core response variables
> 30% improvement in not more than 1 of the 6 JRA/JIA core set variables
≥ 2 cm of worsening must be present if the Physician or Parent Global Assessment is used to define flare
worsening in ≥ 2 joints must be present if the number of active joints or joints with limitation of motion is used to define flare based on changes in the surrogate marker, erythrocyte sedimentation rate (ESR)"|Period B (Day 113 to Day 282)|All treated participants||participants|||Number
703569|NCT00095173|Primary|Time to Occurrence of Juvenile Rheumatoid Arthritis/Juvenile Idiopathic Arthritis (JRA/JIA) Disease Flare During Double-Blind Phase (Period B)|"Time to flare is defined as the elapsed number of days between the first dose date in Period B and the study day that disease flare is confirmed.
All of the following criteria must be met to be defined as a flare:
> 30% worsening in at least 3 of the 6 JRA/JIA core response variables
> 30% improvement in not more than 1 of the 6 JRA/JIA core set variables
≥ 2 cm of worsening must be present if the Physician or Parent Global Assessment is used to define flare
worsening in ≥ 2 joints must be present if the number of active joints or joints with limitation of motion is used to define flare based on changes in the surrogate marker, erythrocyte sedimentation rate (ESR)"|Period B (Day 113 to Day 282)|All treated participants||months||Full Range|Median
703570|NCT00095199|Secondary|Number of Participants With Common Toxicity Criteria (CTC) Grade 3 or 4 Toxicities|National Cancer Institutes-Common Toxicity Criteria version 3.0 was used by investigators to assess participant toxicities. Mapping of investigator verbatim terms to CTCAE terms was done by the sponsor/designee using CTCAE v4.0. Participants reported had grade 3 or 4 toxicities (or both potentially). Grade 3 AEs: severe or medically significant but not immediately life-threatening;hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4 AEs: life-threatening consequences; urgent intervention indicated.|Time from first dose to 30 days after last dose of study therapy up to 28.3 months for Cetuximab & Pemetrexed (versus Pemetrexed alone) and up to 54.3 months for Cetuximab + Docetaxel (versus Docetaxel alone)|All randomized participants receiving at least 1 dose of study drug made up the safety population for this outcome measure. Investigators graded events using CTCAE v3.0. Mapping of investigator verbatim terms for toxicity to CTCAE terms was done by the sponsor/designee using CTCAE v4.0.||participants|||Number
703571|NCT00095199|Secondary|Duration of Overall Response (OR)|The duration of response, in participants with best OR of complete response (CR) or partial response (PR), was measured from the date criteria are met for CR/PR (not confirmation date, whichever was first recorded), until the first occurrence date that the criteria of progressive disease (PD) was met, or death. Participants who were alive and without progression were censored at the date of their last independent review committee (IRC) tumor assessment. The tumor response and progression were assessed by the IRC in the Pemetrexed group and by the investigator in the Docetaxel group.|Time of first occurrence of either (PR) or (CR) to the first date of progressive disease or death up to 32.5 months|All randomized participants with a best overall response of CR or PR. Censored participants: 1 in Cetuximab plus Pemetrexed arm; 2 in Pemetrexed arm; 1 in Cetuximab plus Docetaxel arm; 0 in Docetaxel arm.||months||95% Confidence Interval|Median
703572|NCT00095199|Secondary|Time to Symptomatic Progression|The FACT-LCS (see description in Outcome measure 5) inventories problems specific to lung cancer symptoms. Using this Scale, Symptom progression = a ≥ 2 point decrease from baseline in LCS score maintained for 2 consecutive assessments ≥3 weeks, and <5 weeks, apart. The symptom progression date = the first of 2 consecutive assessments with a ≥2 point decline. Time to symptomatic progression = the time from randomization to the symptom progression date. For participants with no symptom progression, time to symptomatic progression was censored the date of last symptom assessment.|Randomization until symptomatic progression up to 48.3 months|All randomized participants with a baseline LCS >= 2 were included. Censored participants: 237 in Cetuximab plus Pemetrexed arm; 244 in Pemetrexed arm; 126 in Cetuximab plus Docetaxel arm; 131 in Docetaxel arm.||months||95% Confidence Interval|Median
703573|NCT00095199|Secondary|Percentage of Participants With Symptomatic Response (Symptom Response Rates) Using the Lung Cancer Subscale (LCS) Scores of Functional Assessment of Cancer Therapy for Participants With Lung Cancer (FACT-L)|The FACT-LCS is a set of 7 questions to inventory problems specific to lung cancer symptoms. Participants rate each item on a 5-point Likert-type scale from 0 (not at all) to 4 (very much). Scores range from 0-28 and higher score indicates fewer symptoms. Symptom response (improvement) was defined as ≥2 point increase from baseline in the 7-item LCS score that was maintained for 2 consecutive assessments at least 3 weeks, and not >5 weeks apart for participants, whose baseline LCS score was ≤26. Symptom response rate was the percentage of participants with symptomatic response.|At baseline, every 3 weeks and 30 days after end of therapy up to 50 months|The randomized participants with baseline LCS scores less than or equal to 26.||percentage of participants||95% Confidence Interval|Number
703574|NCT00095199|Secondary|Proportion of Randomized Participants With Best Overall Response (OR) of Partial Response (PR), Complete Response (CR), or Stable Disease (SD)|The disease control rate (DCR) was the proportion of randomized participants with a best OR of CR, PR or SD according to modified World Health Organization (WHO) guidelines. It was calculated as the total number of participants with CR, PR or SD divided by the total number of participants randomized in that arm. The tumor response was assessed by the independent review committee (IRC) in the Pemetrexed group and by the investigator in the Docetaxel group.|Randomization to progression of disease or death due to any cause up to 59.6 months|The intent-to-treat population (ITT) included all participants classified according to the treatment arms into which they were randomized, regardless of the actual treatment received.||proportion of participants||95% Confidence Interval|Number
703584|NCT00095212|Secondary|Safety: Number of Subjects Reporting a Skin Reaction to the Patch|Represents number of subjects who reported this symptom from baseline to 18 months. Every 6 weeks,subjects were counseled on appropriate barrier contraception methods and a urine pregnancy was performed. Subjects who experienced increased hair growth (facial hair) could remain in the study on a lower dose of testosterone (1 patch per week), but dose reductions were not necessary and full dosing was continued throughout the study for all subjects. Changes in menstrual status, missed periods and/or irregular bleeding, were noted and reported back to the primary care physician if significant.|Baseline (time 0) to 18 months|||participants|||Number
703575|NCT00095199|Secondary|Proportion of Randomized Participants With the Best Overall Response (OR) of Partial Response (PR) or Complete Response (CR) (Overall Response Rate [ORR])|The best overall response rate (ORR) was the proportion of randomized participants with a best OR of CR or PR, according to modified World Health Organization (WHO) guidelines. It was calculated as the total number of participants with CR or PR divided by the total number of participants treated in that arm. Participants with no post-baseline evaluation were considered as non-responders. The tumor response was assessed by the independent review committee (IRC) in the Pemetrexed group and by the investigator in the Docetaxel group.|Randomization until progression of disease or death from any cause up to 59.6 months|The intent-to-treat population (ITT) included all participants classified according to the treatment arms into which they were randomized, regardless of the actual treatment received.||proportion of participants||95% Confidence Interval|Number
703576|NCT00095199|Secondary|Overall Survival (OS)|OS was defined as the time from randomization to death. Participants without a date of death were censored on the last date participants were known to be alive, or lost to follow-up.|Randomization to the date of death from any cause up to 72.8 months|The intent-to-treat population (ITT) included all participants classified according to the treatment arms into which they were randomized, regardless of the actual treatment received. Censored participants: 24 in Cetuximab + Pemetrexed arm; 43 in Pemetrexed arm; 12 in Cetuximab + Docetaxel arm; 22 in Docetaxel arm.||months||95% Confidence Interval|Median
703577|NCT00095199|Primary|Progression Free Survival (PFS)|PFS was defined as the time from randomization until the date of progressive disease (PD) or death from any cause. Participants who were alive and without progression were censored at the date of their last tumor assessment. PFS was assessed by the independent review committee (IRC) in the Pemetrexed group (Cetuximab & Pemetrexed versus Pemetrexed) and by the investigator in the Docetaxel group (Cetuximab & Docetaxel versus Docetaxel).|Randomization to progression of disease or death due to any cause up to 59.6 months|The intent-to-treat population (ITT) included all participants classified according to the treatment arms into which they were randomized, regardless of the actual treatment received. Censored participants: 10 in Cetuximab + Pemetrexed arm; 25 in Pemetrexed arm; 6 in Cetuximab + Docetaxel arm; 16 in Docetaxel arm.||months||95% Confidence Interval|Median
703578|NCT00095212|Secondary|Strength: Total Knee Extension Performed Via Quantitative Muscle Function Testing.|Represents change in isometric force (measured in kilograms) from baseline to 18 months. Peak isometric force of total knee flexion and extension were measured on the best of 2 repetitions for which subjects held a maximum contraction for 5 seconds.|Baseline (time 0) to 18 months|data not available for all subjects due to malfunctioning equipment at some sessions, and some subjects did not wish to complete testing.||kilograms||Standard Error|Mean
703579|NCT00095212|Secondary|Strength: Total Knee Flexion Performed Via Quantitative Muscle Function Testing.|Represents change in isometric force (measured in kilograms) from baseline to 18 months. Peak isometric force of total knee flexion and extension were measured on the best of 2 repetitions for which subjects held a maximum contraction for 5 seconds.|Baseline (time 0) to 18 months|data not available for all subjects due to malfunctioning equipment at some sessions, and some subjects did not wish to complete testing.||kilograms||Standard Error|Mean
703580|NCT00095212|Secondary|"Neurocognitive Function: Hopkins Verbal Learning Test-revised,Total Recall Z Score Represents Change in Z Score From Baseline to 18 Months."|This test assesses verbal learning and memory. Subjects are given a list of 12 words and asked to repeat as many words as they can recall during 3 separate trials. The Total Recall Z score is calculated based on the sum of total correct responses for Trials 1,2,& 3. A Z score of 0 equals the 50 percentile, a Z score of 1 is 1 standard deviation above the mean and a Z score of -1 is 1 standard deviation below the mean. The lowest and highest T scores for the HVLT-R are ≤20 and ≥80. This correlates to lowest and highest Z scores of ≤ -3.0 and ≥3.0. A lower Z score is indicative of poor recall.|Baseline (time 0) to 18 months|data not available for all subjects as some did not wish to complete the testing||Units on a scale||Standard Error|Mean
703581|NCT00095212|Secondary|Safety: Number of Subjects Reporting a Change in Menstrual Status (Reported More Than One Period in 1 Month or Missed a Period During a Monthly Cycle)|Represents number of subjects who reported this symptom from baseline to 18 months. Every 6 weeks,subjects were counseled on appropriate barrier contraception methods and a urine pregnancy was performed. Subjects who experienced increased hair growth (facial hair) could remain in the study on a lower dose of testosterone (1 patch per week), but dose reductions were not necessary and full dosing was continued throughout the study for all subjects. Changes in menstrual status, missed periods and/or irregular bleeding, were noted and reported back to the primary care physician if significant.|Baseline (time 0) to 18 months|||participants|||Number
703582|NCT00095212|Secondary|Safety: Number of Subjects Reporting Acne|Represents number of subjects who reported this symptom from baseline to 18 months. Every 6 weeks,subjects were counseled on appropriate barrier contraception methods and a urine pregnancy was performed. Subjects who experienced increased hair growth (facial hair) could remain in the study on a lower dose of testosterone (1 patch per week), but dose reductions were not necessary and full dosing was continued throughout the study for all subjects. Changes in menstrual status, missed periods and/or irregular bleeding, were noted and reported back to the primary care physician if significant.|Baseline (time 0) to 18 months|||participants|||Number
703583|NCT00095212|Secondary|Safety: Number of Subjects Reporting a Change in Hair Pattern (Increased Hair on Chin, Upper Lip, Chest, Abdomen, Fore Arms, and Legs)|Represents number of subjects who reported this symptom from baseline to 18 months. Every 6 weeks,subjects were counseled on appropriate barrier contraception methods and a urine pregnancy was performed. Subjects who experienced increased hair growth (facial hair) could remain in the study on a lower dose of testosterone (1 patch per week), but dose reductions were not necessary and full dosing was continued throughout the study for all subjects. Changes in menstrual status, missed periods and/or irregular bleeding, were noted and reported back to the primary care physician if significant.|Baseline (time 0) to 18 months|||participants|||Number
703610|NCT00095303|Secondary|Main Study, Risky Sexual Behaviors at 8 Months Post Randomization|For the Main Study, the total score of the ‘HIV/Sex Risk Behaviors’ measure was used as the outcome. Scores ranged from -0.5 to 6.8. The higher the score, the more risky sexual behavior.|8 months post randomization|||units on a scale||Standard Error|Least Squares Mean
703662|NCT00095498|Secondary|Change From Baseline in Lymphocytes at Month 3|Laboratory hematology lymphocytes|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.||* 10^9/L||Standard Deviation|Mean
703585|NCT00095212|Secondary|Quality of Life/Sexual Function: Brief Index of Sexual Function (BISF-W) Domain 7: Problems Affecting Sexual Function|Represents change in measure from baseline to 18 months. The BISF is 22 items with seven domains: Thoughts and Desires, Arousal, Frequency of Sexual Activity, Receptivity/Initiation, Pleasure, Relationship Satisfaction, and Problems Affecting Sexual Function. Data from Domain 7: Problems Affecting Sexual Function is reported. The score range for this domain is -16 to 75,a higher score indicates greater sexual function.|Baseline (time 0) to 18 months|data not available for all subjects as some did not wish to complete the questionnaire||Units on a scale||Standard Error|Mean
703586|NCT00095212|Secondary|Quality of Life/Depression: Becks Depression Inventory|Represents change in the mean score from baseline to 18 months. Depression was evaluated with the Beck’s Depression Inventory (BDI). The BDI is a 21-item self-report instrument used to assess the presence and severity of symptoms of depression. A Total score in the range of 0-13 is considered minimal, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.|Baseline (time 0) to 18 months|||Units on a scale||Standard Error|Mean
703587|NCT00095212|Secondary|Bone Mineral Density of the Hip|Represents change in measure from baseline to 18 months. 18 month mean and standard error of the mean for bone mineral density of the hip measured by dual energy absorptiometry (DEXA)scan.|Baseline (time 0) to 18 months|||grams per centimeter squared||Standard Error|Mean
703588|NCT00095212|Primary|Lean Body Mass|Represents change in measure from baseline to 18 months. 18 month mean and standard error of the mean for lean body mass measured by dual energy absorptiometry (DEXA)scan.|Baseline (time 0) to 18 months|Responses at 9 and 18 months were pooled as the post treatment repeated measures. All data were included in the analysis, including 9 month data from the 4 subjects who discontinued after the 9 month visit.||kilograms||Standard Error|Mean
703589|NCT00095238|Secondary|Number of Participants With New Onset Atrial Fibrillation (AF) Among Those With No Prior AF History or Evidence of AF on Baseline Electrocardiograph (ECG)|Frequency of new onset AF in participants with no prior AF history or evidence of AF on baseline ECG. Stratified by use of angiotensin-converting enzyme (ACE) inhibitors and measured by adverse events reporting and final ECG recording read by the investigator.|Baseline, Final Visit|Randomized subjects (total=4128) with no prior AF history or evidence of AF on baseline ECG, stratified by use of ACE-I||participants|||Number
703590|NCT00095238|Secondary|Mean Change From Baseline in Glomerular Filtration Rate (GFR)at Month 42, Month 54, Month 66|Based on the Cockcroft-Gault formula calculation, a commonly used surrogate marker to estimate creatinine clearance, which in turn is an approximate measure of GFR. It employs serum creatinine measurements and a patient's weight to predict the creatinine clearance. Adjusted for baseline GFR and angiotensin-converting enzyme inhibitor use at baseline (ACE-I). A decrease from baseline signifies worsening. The adjusted mean change from baseline value is from the model (calculated prior to rounding), whereas the other two points are the baseline mean and post mean.|Baseline, Month 42, Month 54, Month 66|Participants with baseline score and score at timepoint.||mL/min/1.73m2||Standard Error|Mean
703591|NCT00095238|Secondary|Mean Change From Baseline in Glomerular Filtration Rate (GFR) at Month 6, Month 18, and Month 30|Based on the Cockcroft-Gault formula calculation, a commonly used surrogate marker to estimate creatinine clearance, which in turn is an approximate measure of GFR. It employs serum creatinine measurements and a patient's weight to predict the creatinine clearance. Adjusted for baseline GFR and angiotensin-converting enzyme inhibitor use at baseline (ACE-I). A decrease from baseline signifies worsening. The adjusted mean change from baseline value is from the model (calculated prior to rounding), whereas the other two points are the baseline mean and post mean.|Baseline, Month 6, Month 18, Month 30|Participants with baseline score and score at timepoint.||mL/min/1.73m2||Standard Error|Mean
703592|NCT00095238|Secondary|Percentage of Participants With New Onset of Diabetes Among Subjects With No Prior Diabetes History at Given Timepoints|Treatment comparisons for time to new onset of diabetes (from adverse event reporting) among subjects with no prior history of diabetes.|Year 1, Year 2, Year 3, Year 4, Year 5|Randomized participants with no prior diabetes history||percentage of participants|||Number
703593|NCT00095238|Secondary|Percentage of Participants Experiencing Protocol-specified Cardiovascular (CV) Hospitalization at Given Timepoints|Treatment comparisons for time to protocol-specified CV hospitalization. Protocol-specified CV hospitalizations include hospitalizations ≥24 hrs or involve a calendar date change for a primary cause of worsening heart failure, unstable angina, myocardial infarction, ventricular dysrhythmia, atrial dysrhythmia or stroke that also requires intravenous or intramuscular therapy or a related procedure or significant augmentation of oral therapy. Protocol specified CV hospitalizations also include myocardial infarction or stroke occurring during any hospitalization.|Year 1, Year 2, Year 3, Year 4, Year 5|||percentage of participants|||Number
703594|NCT00095238|Secondary|Percentage of Participants Experiencing CV Death or CV Hospitalization at Given Timepoints|Treatment comparisons for time to CV death or CV hospitalization. Protocol-specified CV hospitalizations include hospitalizations ≥24 hrs or involve a calendar date change for a primary cause of worsening heart failure, unstable angina, myocardial infarction, ventricular dysrhythmia, atrial dysrhythmia or stroke that also requires intravenous or intramuscular therapy or a related procedure or significant augmentation of oral therapy. Protocol specified CV hospitalizations also include myocardial infarction or stroke occurring during any hospitalization.|Year 1, Year 2, Year 3, Year 4, Year 5|randomized participants||percentage of participants|||Number
703595|NCT00095238|Secondary|Participant Assessment of Dyspnea at Month 6, Month 14, and Final Visit Compared With Baseline|Assessments are directly based on the Case Report Form (CRF). If the post-randomization CRF assessment was missing and the subject died, was hospitalized for worsening heart failure, or discontinued study medication for worsening heart failure, the subject was considered as having a Major Event. Participants who are summarized under Major Events are categorized as Worsened Markedly.|Baseline, Month 6, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.|Randomized Participants||Participants|||Number
703596|NCT00095238|Secondary|Participant Assessment of Fatigue at Month 6, Month 14, and Final Visit Compared With Baseline|Assessments are directly based on the Case Report Form (CRF). If the post-randomization CRF assessment was missing and the subject died, was hospitalized for worsening heart failure, or discontinued study medication for worsening heart failure, the subject was considered as having a Major Event. Participants who are summarized under Major Events are categorized as Worsened Markedly.|Baseline, Month 6, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.|Randomized Participants||Participants|||Number
703597|NCT00095238|Secondary|Participant Assessment of Heart Failure Status at Month 6, Month 14, and Final Visit Compared With Baseline|Assessments are directly based on the Case Report Form (CRF). If the post-randomization CRF assessment was missing and the subject died, was hospitalized for worsening heart failure, or discontinued study medication for worsening heart failure, the subject was considered as having a Major Event. Participants who are summarized under Major Events are categorized as Worsened Markedly.|Baseline, Month 6, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.|Randomized Participants||Participants|||Number
703598|NCT00095238|Secondary|Physician Assessment of Heart Failure Status at Month 6, Month 14, and Final Visit Compared With Baseline|This was an assessment of the change in overall physician opinion of change from baseline status. Assessments are directly based on the Case Report Form (CRF). If the post-randomization CRF assessment was missing and the subject died, was hospitalized for worsening heart failure, or discontinued study medication for worsening heart failure, the subject was considered as having a Major Event. Participants who are summarized under Major Events are categorized as Worsened Markedly.|Baseline, Month 6, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.|||participants|||Number
703599|NCT00095238|Secondary|Change From Baseline in the New York Heart Association (NYHA) Functional Class at Month 6, Month 10, Month 14, and Final Visit|NYHA functional classification=4-tiered system relating symptoms to everyday activities & quality of life. (See Reporting Groups for description of each class.) Change of NYHA functional class from baseline was grouped into 3 categories: improved, unchanged, or worsened (based on case report form [CRF] assessment). If a post-randomization CRF assessment was missing or participant died, was hospitalized for worsening heart failure or discontinued study medication for worsening heart failure, the participant was classified as Major Event.|Baseline, Month 6, Month 10, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.|Randomized participants with measurement at baseline and Month 6, Month 10, Month 14, and Final Visit||participants|||Number
703600|NCT00095238|Secondary|Percentage of Participants Experiencing All-cause Death at Given Time Points|Treatment comparisons for time to all-cause death|Year 1, Year 2, Year 3, Year 4, Year 5|Randomized subjects||percentage of participants|||Number
703601|NCT00095238|Secondary|Percentage of Participants Experiencing Cardiovascular Death at Given Timepoints|Treatment comparisons for time to cardiovascular death|Year 1, Year 2, Year 3, Year 4, Year 5|Randomized Subjects||percentage of participants|||Number
703602|NCT00095238|Secondary|Percentage of Participants Experiencing CV Death, Non-Fatal Myocardial Infarction (MI), or Non-Fatal Stroke at Given Timepoints|Treatment comparisons for time to cardiovascular death, non-fatal MI, or non-fatal stroke.|Year 1, Year 2, Year 3, Year 4, Year 5|Randomized Participants||percentage of participants|||Number
703603|NCT00095238|Secondary|Change From Baseline in B-Type Natriuretic Peptide (Pro-BNP) at Month 6 and Month 14|Adjusted ratio to baseline in geometric mean in Pro-BNP in the blood. Ratio to Baseline = On-therapy geometric mean divided by baseline geometric mean. A lower score signifies improvement. Change from baseline adjusted for baseline value and angiotensin converting enzyme inhibitor use at baseline. Analysis uses natural logarithms of excretion rate values.|Baseline, Month 6, Month 14|number of participants with measurement at baseline and at timepoint||pg/mL||Standard Error|Geometric Mean
703604|NCT00095238|Secondary|Minnesota Living With Heart Failure (MLwHF) Total Score (Sum of Questions 1-21) at Final Visit|Mean score at baseline and final visit in Minnesota Living with Heart Failure (MLWHF) questionnaire, a 21-item, patient-reported, 6-point (ranging from 0-5; higher score=poorer quality of life; highest possible score=105) measurement of quality of life in persons with heart failure.|Baseline, Final Visit=last scheduled visit specified in the protocol at conclusion of the entire study by the sponsor. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.|Participants with baseline score and score at timepoint.||units on a scale||Standard Error|Mean
703605|NCT00095238|Secondary|Minnesota Living With Heart Failure (MLwHF) Total Score (Sum of Questions 1-21) at Month 6 and Month 14|Mean score and adjusted mean change from baseline in Minnesota Living with Heart Failure (MLWHF) questionnaire, a 21-item, patient-reported, 6-point (ranging from 0-5; higher score=poorer quality of life; highest possible score=105) measurement of quality of life in persons with heart failure.|Baseline, Month 6, Month 14|Participants with baseline score and score at timepoint.||units on a scale||Standard Error|Mean
703606|NCT00095238|Secondary|Percentage of Participants Experiencing Heart Failure Mortality or Heart Failure Hospitalization at Given Time Points|Treatment comparisons for time to heart failure mortality or heart failure hospitalization|Year 1, Year 2, Year 3, Year 4, Year 5|Randomized Participants||percentage of participants|||Number
703607|NCT00095238|Primary|Percentage of Participants With First Occurrence of the Composite Outcome of Death (All Cause) or Protocol-Specified Cardiovascular (CV) Hospitalization at Given Timepoints|Treatment comparisons for time to first occurrence of composite outcome of all-cause death (composite outcome of death) or protocol-specified CV hospitalization. Protocol-specified CV hospitalizations include those ≥24 hrs or involving a calendar date change for a primary cause of worsening heart failure, unstable angina, myocardial infarction, ventricular or atrial dysrhythmia, or stroke, that also require intravenous or intramuscular therapy or a related procedure or significant augmentation of oral therapy. In addition, MI or stroke during any hospitalization are included.|Year 1, Year 2, Year 3, Year 4, Year 5|Randomized Participants||percentage of participants|||Number
703608|NCT00095303|Secondary|Follow Up Study, Risky Sexual Behaviors|For the Follow Up Study, sexual risk behavior was measured by examining the number of unprotected sexual acts and the number of partners and number of sex acts that included substance use the in the 90 day period that preceded the assessment; a latent factor using structural equation modeling will be used created from the Behavioral Risk Assessment. Scores ranged from -0.5 to 11.7. The higher the score, the more risky sexual behavior.|90 days prior assessment|||units on a scale||Standard Error|Least Squares Mean
703609|NCT00095303|Secondary|Main Study, Risky Sexual Behaviors at 12 Months Post Randomization|For the Main Study, the total score of the ‘HIV/Sex Risk Behaviors’ measure was used as the outcome. Scores ranged from -0.5 to 6.7. The higher the score, the more risky sexual behavior.|12 months post randomization|||units on a scale||Standard Error|Least Squares Mean
703663|NCT00095498|Secondary|Change From Baseline in Lymphocytes at Month 1|Laboratory hematology lymphocytes|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.||* 10^9/L||Standard Deviation|Mean
703614|NCT00095303|Secondary|Main Study, Level of Family Functioning at 12 Months Post Randomization|The four components of the ‘Parenting Practices Inventory’ used to create a composite for use in this analysis. The four component scales from the Parenting Practices Inventory are ‘Positive Parenting’, ‘Discipline Effectiveness,’ ‘Avoidance of Discipline’ and ‘Monitoring’ scales from the Pittsburgh Youth Survey. the family functioning composite was standardized by the full sample standard deviation at baseline.Scores ranged from -2.6 to 2.0. The higher the score, the better outcome of family functioning.|12 months post randomization|||units on a scale||Standard Deviation|Mean
703615|NCT00095303|Secondary|Main Study, Level of Family Functioning at 8 Months Post Randomization|The four components of the ‘Parenting Practices Inventory’ used to create a composite for use in this analysis. The four component scales from the Parenting Practices Inventory are ‘Positive Parenting’, ‘Discipline Effectiveness,’ ‘Avoidance of Discipline’ and ‘Monitoring’ scales from the Pittsburgh Youth Survey. the family functioning composite was standardized by the full sample standard deviation at baseline.Scores ranged from -2.8 to 2.0. The higher the score, the better outcome of family functioning.|8 months post randomization|||units on a scale||Standard Deviation|Mean
703616|NCT00095303|Secondary|Main Study, Level of Family Functioning at 4 Months Post Randomization|The four components of the ‘Parenting Practices Inventory’ used to create a composite for use in this analysis. The four component scales from the Parenting Practices Inventory are ‘Positive Parenting’, ‘Discipline Effectiveness,’ ‘Avoidance of Discipline’ and ‘Monitoring’ scales from the Pittsburgh Youth Survey. the family functioning composite was standardized by the full sample standard deviation at baseline. Scores ranged from -2.9 to 1.8. The higher the score, the better outcome of family functioning.|4 months post randomization|||units on a scale||Standard Deviation|Mean
703617|NCT00095303|Secondary|Main Study, Level of Family Functioning at Baseline|The four components of the ‘Parenting Practices Inventory’ used to create a composite for use in this analysis. The four component scales from the Parenting Practices Inventory are ‘Positive Parenting’, ‘Discipline Effectiveness,’ ‘Avoidance of Discipline’ and ‘Monitoring’ scales from the Pittsburgh Youth Survey. the family functioning composite was standardized by the full sample standard deviation at baseline. Scores ranged from -3.0 to 1.8. The higher the score, the better outcome of family functioning.|Baseline|||units on a scale||Standard Error|Mean
703618|NCT00095303|Secondary|Follow Up Study, Externalizing Behavior|For the follow up study, externalizing behavior for the 90 days prior to the follow up was assessed using the externalizing composite of the Adult Self Report (ASR). The ASR is a 123 item self report scale designed for 18 to 59 year-old to describe their own functioning. Items are on a 3 point likert type scale (0= not true, 1=somewhat true, 2=very true or often true). The externalizing scale is comprised by the aggressive, rule braking and intrusive syndromes. The problem syndromes have been normed by sex and age (18 to 35, or 36 to 59), using a nationally representative sample. Scores were square-root transformed to more closely approximate a normal distribution. Scores ranged from 0 to 7.2. The higher the score, the more externalizing behavior. Participants were also asked to self report arrests in the past year . Externalizing was analyzed using regression|90 days prior to assessment|||units on a scale||Standard Deviation|Mean
703619|NCT00095303|Primary|Follow Up Study, Drug Use|Timeline Follow Back (TLFB) measured drug use. For the Follow Up Study, the TLFB was used to identify drug use in the 90 day period that preceded the assessment. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use over the past 90 days. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use.The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 90 days.|Number of self reported drug use days 90 days prior to assessment|||days of drug use 90 days prior assessmen||Inter-Quartile Range|Median
703620|NCT00095303|Primary|Follow Up Study, Drug Use|Timeline Follow Back (TLFB) measured drug use. For the Follow Up Study, the TLFB was used to identify drug use in the 90 day period that preceded the assessment. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use over the past 90 days. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use.The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 90 days.|Number of self reported drug use days 90 days prior assessment|||days of drug use 90 days prior assessmen||Inter-Quartile Range|Median
703621|NCT00095303|Primary|Main Study, Adolescent Drug Use|Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.|Number of self reported drug use days from day 337-364|The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 337-364. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.||days of drug use from day 337-364||Inter-Quartile Range|Median
703664|NCT00095498|Secondary|Change From Baseline in Hemoglobin at Month 12|Laboratory hematology hemoglobin|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.||g/L||Standard Deviation|Mean
703665|NCT00095498|Secondary|Change From Baseline in Hemoglobin at Month 6|Laboratory hematology hemoglobin|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.||g/L||Standard Deviation|Mean
703622|NCT00095303|Primary|Main Study, Adolescent Drug Use|Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.|Number of self reported drug use days from day 309-336|The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 309-336. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.||days of drug use from day 309-336||Inter-Quartile Range|Median
703623|NCT00095303|Primary|Main Study, Adolescent Drug Use|Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.|Number of self reported drug use from days 281-308|The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 281-308. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.||days of drug use from day 281-308||Inter-Quartile Range|Median
703624|NCT00095303|Primary|Main Study, Adolescent Drug Use|Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.|Number of self reported drug use days from day 253-280|The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 253-280. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.||days of drug use from day 253-280||Inter-Quartile Range|Median
703625|NCT00095303|Primary|Main Study, Adolescent Drug Use|Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.|Number of self reported drug use days from day 225-252|The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 225-252. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.||days of drug use from day 225-252||Inter-Quartile Range|Median
703626|NCT00095303|Primary|Main Study, Adolescent Drug Use|Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.|Number of self reported drug use days from day 197-224|The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 197-224. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.||days of drug use from day 197-224||Inter-Quartile Range|Median
703666|NCT00095498|Secondary|Change From Baseline in Hemoglobin at Month 3|Laboratory hematology hemoglobin|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.||g/L||Standard Deviation|Mean
703667|NCT00095498|Secondary|Change From Baseline in Hemoglobin at Month 1|Laboratory hematology hemoglobin|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.||g/L||Standard Deviation|Mean
703668|NCT00095498|Secondary|Change From Baseline in Hematocrit at Month 12|Laboratory hematology hematocrit|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.||Proportion of red blood cells in blood||Standard Deviation|Mean
703627|NCT00095303|Primary|Main Study, Adolescent Drug Use|Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.|Number of self reported drug use days from day 169-196|The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 169-196. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.||days of drug use from day 169-196||Inter-Quartile Range|Median
703628|NCT00095303|Primary|Main Study, Adolescent Drug Use|Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.|Number of self reported drug use days from day 141 - 168|The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 141-168. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.||days of drug use from day 141-168||Inter-Quartile Range|Median
703629|NCT00095303|Primary|Main Study, Adolescent Drug Use|Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.|Number of self reported drug use days from day 113-140|The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 113-140. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.||days of drug use from days 113-140||Inter-Quartile Range|Median
703630|NCT00095303|Primary|Main Study, Adolescent Drug Use|Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.|Number of self reported drug use days from day 85-112|The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 85-112. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.||days of drug use from day 85-112||Inter-Quartile Range|Median
703631|NCT00095303|Primary|Main Study, Adolescent Drug Use|Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.|Number of self reported drug use days from day 57-84|The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 57-84. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.||days of drug use from day 57-84||Inter-Quartile Range|Median
703669|NCT00095498|Secondary|Change From Baseline in Hematocrit at Month 6|Laboratory hematology hematocrit|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.||Proportion of red blood cells in blood||Standard Deviation|Mean
703670|NCT00095498|Secondary|Change From Baseline in Hematocrit at Month 3|Laboratory hematology hematocrit|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.||Proportion of red blood cells in blood||Standard Deviation|Mean
703671|NCT00095498|Secondary|Change From Baseline in Hematocrit at Month 1|Laboratory hematology hematocrit|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.||Proportion of red blood cells in blood||Standard Deviation|Mean
703632|NCT00095303|Secondary|Main Study, Externalizing Behavior at 12 Months Post Randomization|For the Main study, an equally weighted composite of the following standardized scales was used to assess externalizing behaviors: ‘Total Delinquency’ from the National Youth Survey; ‘Oppositional Defiant Disorder’ and ‘Conduct Problems’ from the Diagnostic Interview Schedule for Children-Predictive Scales, ‘Externalizing Scale’ from the Youth Self-Report. This composite was then transformed to a z-score using the mean and standard deviation of the baseline in the entire sample. Adolescent externalizing behaviors were assessed at 4-, 8-, and 12-months post randomization.This hypothesis analyzed using hierarchical linear models. Scores ranged from -1.6 to 3.4. The higher the score, the more externalizing behavior.|12 months post randomization|The number of participants analyzed represents the number of participants that completed this time point, assessing for externalizing behavior at 12 months post randomization. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.||units on a scale||Standard Deviation|Mean
703633|NCT00095303|Secondary|Main Study, Externalizing Behavior at 8 Months Post Randomization|For the Main study, an equally weighted composite of the following standardized scales was used to assess externalizing behaviors: ‘Total Delinquency’ from the National Youth Survey; ‘Oppositional Defiant Disorder’ and ‘Conduct Problems’ from the Diagnostic Interview Schedule for Children-Predictive Scales, ‘Externalizing Scale’ from the Youth Self-Report. This composite was then transformed to a z-score using the mean and standard deviation of the baseline in the entire sample. Adolescent externalizing behaviors were assessed at 4-, 8-, and 12-months post randomization.This hypothesis analyzed using hierarchical linear models. Scores ranged from -1.6 to 3.5. The higher the score, the more externalizing behavior.|8 months post randomization|The number of participants analyzed represents the number of participants that completed this time point, assessing for externalizing behavior at 8 months post randomization. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.||units on a scale||Standard Deviation|Mean
703634|NCT00095303|Primary|Main Study, Adolescent Drug Use|Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.|Number of self reported drug use days in days 29-56|The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 29-56. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.||days of drug use in days 29-56||Inter-Quartile Range|Median
703635|NCT00095303|Secondary|Main Study, Externalizing Behavior at 4 Months Post Randomization|For the Main study, an equally weighted composite of the following standardized scales was used to assess externalizing behaviors: ‘Total Delinquency’ from the National Youth Survey; ‘Oppositional Defiant Disorder’ and ‘Conduct Problems’ from the Diagnostic Interview Schedule for Children-Predictive Scales, ‘Externalizing Scale’ from the Youth Self-Report. This composite was then transformed to a z-score using the mean and standard deviation of the baseline in the entire sample. Adolescent externalizing behaviors were assessed at 4-, 8-, and 12-months post randomization.This hypothesis analyzed using hierarchical linear models. Scores ranged from -1.6 to 3.8. The higher the score, the more externalizing behavior.|4 months post randomization|The number of participants analyzed represents the number of participants that completed this time point, assessing for externalizing behavior at 4 months post randomization. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.||units on a scale||Standard Deviation|Mean
703636|NCT00095303|Secondary|Main Study, Externalizing Behaviors at Baseline|For the Main study, an equally weighted composite of the following standardized scales was used to assess externalizing behaviors: ‘Total Delinquency’ from the National Youth Survey; ‘Oppositional Defiant Disorder’ and ‘Conduct Problems’ from the Diagnostic Interview Schedule for Children-Predictive Scales, ‘Externalizing Scale’ from the Youth Self-Report. This composite was then transformed to a z-score using the mean and standard deviation of the baseline in the entire sample. Adolescent externalizing behaviors were assessed at 4-, 8-, and 12-months post randomization.This hypothesis analyzed using hierarchical linear models. Scores ranged from -1.6 to 3.0. The higher the score, the more externalizing behavior.|Baseline|The number of participants analyzed represents the number of participants that completed this time point, assessing externalizing behaviors at baseline. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.||units on a scale||Standard Deviation|Mean
703637|NCT00095303|Primary|Main Study, Adolescent Drug Use|Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.|Number of self reported drug use days from day 1-28|The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 1-28. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.||days of drug use from day 1-28||Inter-Quartile Range|Median
703672|NCT00095498|Secondary|Change From Baseline in Eosinophils at Month 12|Laboratory hematology eosinophils|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.||* 10^9/L||Standard Deviation|Mean
703638|NCT00095303|Primary|Main Study, Adolescent Drug Use|Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.|Number of self reported drug use days from 28 days prior to baseline|The number of participants analyzed represents the number of participants that completed the baseline time point, assessing for the past 28 days. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.||days of drug use 28 days prior baseline||Inter-Quartile Range|Median
703639|NCT00095498|Secondary|Number of Participants With Laboratory Common Terminology Criteria for Adverse Events (CTCAE) Grade Greater or Equal to 3|"Participants with laboratory toxicity of grade 3 or 4, graded according to the Common Terminology Criteria for Adverse Events, version 3.0, on the following general guideline:
Grade 1 - Mild AE; Grade 2 - Moderate AE; Grade 3 - Severe AE; Grade 4 - Life-threatening or disabling AE; Grade 5 - Death related to AE."|Month 1, month 3, month 6, month 12|Patients who received at least 1 dose of investigational product.||Participants|||Number
703640|NCT00095498|Secondary|Change From Baseline in White Blood Cells at Month 12|Laboratory hematology white blood cells|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.||* 10^9/L||Standard Deviation|Mean
703641|NCT00095498|Secondary|Change From Baseline in White Blood Cells at Month 6|Laboratory hematology white blood cells|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.||* 10^9/L||Standard Deviation|Mean
703642|NCT00095498|Secondary|Change From Baseline in White Blood Cells at Month 3|Laboratpry hematology white blood cells|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.||* 10^9/L||Standard Deviation|Mean
703643|NCT00095498|Secondary|Change From Baseline in White Blood Cells at Month 1|Laboratory hematology white blood cells|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.||* 10^9/L||Standard Deviation|Mean
703644|NCT00095498|Secondary|Change From Baseline in Red Blood Cells at Month 12|Laboratory hematology red blood cells|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.||* 10^9/L||Standard Deviation|Mean
703645|NCT00095498|Secondary|Change From Baseline in Red Blood Cells at Month 6|Laboratory hematology red blood cells|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.||* 10^9/L||Standard Deviation|Mean
703646|NCT00095498|Secondary|Change From Baseline in Red Blood Cells at Month 3|Laboratory hematology red blood cells|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.||* 10^9/L||Standard Deviation|Mean
703647|NCT00095498|Secondary|Change From Baseline in Red Blood Cells at Month 1|Laboratory hematology red blood cells|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.||* 10^9/L||Standard Deviation|Mean
703648|NCT00095498|Secondary|Change From Baseline in Platelets at Month 12|Laboratory hematology platelets|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.||* 10^9/L||Standard Deviation|Mean
703649|NCT00095498|Secondary|Change From Baseline in Platelets at Month 6|Laboratory hematology platelets|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.||* 10^9/L||Standard Deviation|Mean
703650|NCT00095498|Secondary|Change From Baseline in Platelets at Month 3|Laboratory hematology platelets|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.||* 10^9/L||Standard Deviation|Mean
703651|NCT00095498|Secondary|Change From Baseline in Platelets at Month 1|Laboratory hematology platelets|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.||* 10^9/L||Standard Deviation|Mean
703652|NCT00095498|Secondary|Change From Baseline in Total Neutrophils at Month 12|Laboratory hematology total neutrophils|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.||* 10^9/L||Standard Deviation|Mean
703653|NCT00095498|Secondary|Change From Baseline in Total Neutrophils at Month 6|Laboratory hematology total neutrophils|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.||* 10^9/L||Standard Deviation|Mean
703654|NCT00095498|Secondary|Change From Baseline in Total Neutrophils at Month 3|Laboratory hematology total neutrophils|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.||* 10^9/L||Standard Deviation|Mean
703655|NCT00095498|Secondary|Change From Baseline in Total Neutrophils at Month 1|Laboratory hematology total neutrophils|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.||* 10^9/L||Standard Deviation|Mean
703656|NCT00095498|Secondary|Change From Baseline in Monocytes at Month 12|Laboratory hematology monocytes|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.||* 10^9/L||Standard Deviation|Mean
703657|NCT00095498|Secondary|Change From Baseline in Monocytes at Month 6|Laboratory hematology monocytes|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.||* 10^9/L||Standard Deviation|Mean
703658|NCT00095498|Secondary|Change From Baseline in Monocytes at Month 3|Laboratory hematology monocytes|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.||* 10^9/L||Standard Deviation|Mean
703680|NCT00095498|Secondary|Change From Baseline in Alanine Amino Transferase at Month 12|Laboratory chemistry alanine amino transferase|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.||U/L||Standard Deviation|Mean
703681|NCT00095498|Secondary|Change From Baseline in Alanine Amino Transferase at Month 6|Laboratory chemistry alanine amino transferase|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.||U/L||Standard Deviation|Mean
703682|NCT00095498|Secondary|Change From Baseline in Alanine Amino Transferase at Month 3|Laboratory Chemistry alanine amino transferase|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.||U/L||Standard Deviation|Mean
703683|NCT00095498|Secondary|Change From Baseline in Alanine Amino Transferase at Month 1|Laboratory chemistry alanine amino transferase|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.||U/L||Standard Deviation|Mean
703684|NCT00095498|Secondary|Change From Baseline in Aspartate Amino Transferase at Month 12|Laboratory chemistry aspartate amino transferase|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.||U/L||Standard Deviation|Mean
703685|NCT00095498|Secondary|Change From Baseline in Aspartate Amino Transferase|Laboratory chemistry aspartate amino transferase|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.||U/L||Standard Deviation|Mean
703686|NCT00095498|Secondary|Change From Baseline in Aspartate Amino Transferase at Month 3|Laboratory chemistry aspartate amino transferase|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.||U/L||Standard Deviation|Mean
703687|NCT00095498|Secondary|Change From Baseline in Aspartate Amino Transferase at Month 1|Laboratory chemistry aspartate amino transferase|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.||U/L||Standard Deviation|Mean
703688|NCT00095498|Secondary|Change From Baseline in Total Protein at Month 12|Laboratory chemistry total protein|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.||g/L||Standard Deviation|Mean
703689|NCT00095498|Secondary|Change From Baseline in Total Protein at Month 6|Laboratory chemistry total protein|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.||g/L||Standard Deviation|Mean
703690|NCT00095498|Secondary|Change From Baseline in Total Protein at Month 3|Laboratory chemistry total protein|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.||g/L||Standard Deviation|Mean
703691|NCT00095498|Secondary|Change From Baseline in Total Protein at Month 1|Laboratory chemistry total protein|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.||g/L||Standard Deviation|Mean
703692|NCT00095498|Secondary|Change From Baseline in Phosphorus at Month 12|Change From Baseline in Phosphorus at Month 12|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.||mmol/L||Standard Deviation|Mean
703693|NCT00095498|Secondary|Change From Baseline in Phosphorus at Month 6|Laboratory chemistry phosphorus|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.||mmol/L||Standard Deviation|Mean
703694|NCT00095498|Secondary|Change From Baseline in Phosphorus at Month 3|Laboratory chemistry phosphorus|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.||mmol/L||Standard Deviation|Mean
703695|NCT00095498|Secondary|Change From Baseline in Phosphorus at Month 1|Laboratory chemistry phosphorus|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.||mmol/L||Standard Deviation|Mean
703696|NCT00095498|Secondary|Change From Baseline in Sodium at Month 12|Laboratory chemistry sodium|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.||mmol/L||Standard Deviation|Mean
703697|NCT00095498|Secondary|Change From Baseline in Sodium at Month 6|Laboratory chemistry sodium|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.||mmol/L||Standard Deviation|Mean
703698|NCT00095498|Secondary|Change From Baseline in Sodium at Month 3|Change From Baseline in Sodium at Month 3|Baseline, Month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.||mmol/L||Standard Deviation|Mean
703699|NCT00095498|Secondary|Change From Baseline in Sodium at Month 1|Laboratory chemistry sodium|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.||mmol/L||Standard Deviation|Mean
703700|NCT00095498|Secondary|Change From Baseline in Magnesium at Month 12|Laboratory chemistry magnesium|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.||mmol/L||Standard Deviation|Mean
703701|NCT00095498|Secondary|Change From Baseline in Magnesium at Month 6|Laboratory chemistry magnesium|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.||mmol/L||Standard Deviation|Mean
703702|NCT00095498|Secondary|Change From Baseline in Magnesium at Month 3|Laboratory chemistry magnesium|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.||mmol/L||Standard Deviation|Mean
703703|NCT00095498|Secondary|Change From Baseline in Magnesium at Month 1|Laboratory chemistry magnesium|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.||mmol/L||Standard Deviation|Mean
703704|NCT00095498|Secondary|Change From Baseline in Potassium at Month 12|Laboratory chemistry potassium|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.||mmol/L||Standard Deviation|Mean
703705|NCT00095498|Secondary|Change From Baseline in Potassium at Month 6|Laboratory chemistry potassium|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.||mmol/L||Standard Deviation|Mean
703706|NCT00095498|Secondary|Change From Baseline in Potassium at Month 3|Laboratory chemistry potassium|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.||mmol/L||Standard Deviation|Mean
703707|NCT00095498|Secondary|Change From Baseline in Potassium at Month 1|Laboratory chemistry potassium|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.||mmol/L||Standard Deviation|Mean
703708|NCT00095498|Secondary|Change From Baseline in Glucose at Month 12|Laboratory chemistry glucose|baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.||mmol/L||Standard Deviation|Mean
703709|NCT00095498|Secondary|Change From Baseline in Glucose at Month 6|Laboratory chemistry glucose|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.||mmol/L||Standard Deviation|Mean
703710|NCT00095498|Secondary|Change From Baseline in Glucose at Month 3|Laboratory chemistry glucose|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.||mmol/L||Standard Deviation|Mean
703711|NCT00095498|Secondary|Change From Baseline in Glucose at Month 1|Laboratory chemistry glucose|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.||mmol/L||Standard Deviation|Mean
703712|NCT00095498|Secondary|Change From Baseline in Gamma-Glutamyl Transferase at Month 12|Laboratory chemistry gamma-glutamyl transferase|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.||U/L||Standard Deviation|Mean
703713|NCT00095498|Secondary|Change From Baseline in Gamma-Glutamyl Transferase at Month 6|Laboratory chemistry gamma-glutamyl transferase|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.||U/L||Standard Deviation|Mean
703714|NCT00095498|Secondary|Change From Baseline in Gamma-Glutamyl Transferase at Month 3|Laboratory chemistry gamma-glutamyl transferase|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.||U/L||Standard Deviation|Mean
703715|NCT00095498|Secondary|Change From Baseline in Gamma-Glutamyl Transferase at Month 1|Laboratory chemistry gamma-glutamyl transferase|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.||U/L||Standard Deviation|Mean
703716|NCT00095498|Secondary|Change From Baseline in Creatinine at Month 12|Laboratory chemistry creatinine|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.||µmol/L||Standard Deviation|Mean
703717|NCT00095498|Secondary|Change From Baseline in Creatinine at Month 6|Laboratory chemistry creatinine|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.||µmol/L||Standard Deviation|Mean
703718|NCT00095498|Secondary|Change From Baseline in Creatinine at Month 3|Laboratory chemistry creatinine|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.||µmol/L||Standard Deviation|Mean
703719|NCT00095498|Secondary|Change From Baseline in Creatinine at Month 1|Laboratory chemistry creatinine|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.||µmol/L||Standard Deviation|Mean
703720|NCT00095498|Secondary|Change From Baseline in Chloride at Month 12|Laboratory chemistry chloride|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.||mmol/L||Standard Deviation|Mean
703721|NCT00095498|Secondary|Change From Baseline in Chloride at Month 6|Laboratory chemistry chloride|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.||mmol/L||Standard Deviation|Mean
703722|NCT00095498|Secondary|Change From Baseline in Chloride at Month 3|Laboratory chemistry chloride|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.||mmol/L||Standard Deviation|Mean
703723|NCT00095498|Secondary|Change From Baseline in Chloride at Month 1|Laboratory chemistry chloride|baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.||mmol/L||Standard Deviation|Mean
703724|NCT00095498|Secondary|Change From Baseline in Calcium (Corrected) at Month 12|Laboratory chemistry albumin-adjusted calcium|Baselien, Month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.||mmol/L||Standard Deviation|Mean
703725|NCT00095498|Secondary|Change From Baseline in Calcium (Corrected) at Month 6|Laboratory chemistry albumin-adjusted calcium|Baseline, Month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.||mmol/L||Standard Deviation|Mean
703726|NCT00095498|Secondary|Change From Baseline in Calcium (Corrected) at Month 3|Laboratory chemistry albumin-adjusted calcium|baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.||mmol/L||Standard Deviation|Mean
703727|NCT00095498|Secondary|Change From Baseline in Calcium (Corrected) at Month 1|Laboratory chemistry albumin-adjusted calcium|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.||mmol/L||Standard Deviation|Mean
703728|NCT00095498|Secondary|Change From Baseline in Calcium at Month 12|Laboratory chemistry calcium|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.||mmol/L||Standard Deviation|Mean
703729|NCT00095498|Secondary|Change From Baseline in Calcium at Month 6|Laboratory chemistry calcium|baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.||mmol/L||Standard Deviation|Mean
703730|NCT00095498|Secondary|Change From Baseline in Calcium at Month 3|Laboratory chemistry calcium|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.||mmol/L||Standard Deviation|Mean
703731|NCT00095498|Secondary|Change From Baseline in Calcium at Month 1|Laboratory chemistry calcium|baseline. month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.||mmol/L||Standard Deviation|Mean
703732|NCT00095498|Secondary|Change From Baseline in Blood Urea Nitrogen at Month 12|Laboratory chemistry blood urea nitrogen|baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.||mmol/L||Standard Deviation|Mean
703733|NCT00095498|Secondary|Change From Baseline in Blood Urea Nitrogen at Month 6|Laboratory chemistry blood urea nitrogen|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.||mmol/L||Standard Deviation|Mean
703734|NCT00095498|Secondary|Change From Baseline in Blood Urea Nitrogen at Month 3|Laboratory chemistry blood urea nitrogen|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.||mmol/L||Standard Deviation|Mean
703735|NCT00095498|Secondary|Change From Baseline in Blood Urea Nitrogen at Month 1|Laboratory chemistry blood urea nitrogen|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.||mmol/L||Standard Deviation|Mean
703736|NCT00095498|Secondary|Change From Baseline in Total Bilirubin at Month 12|Laboratory chemistry total bilirubin|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.||umol/L||Standard Deviation|Mean
703737|NCT00095498|Secondary|Change From Baseline in Total Bilirubin at Month 6|Laboratory chemistry total bilirubin|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.||umol/L||Standard Deviation|Mean
703738|NCT00095498|Secondary|Change From Baseline in Total Bilirubin at Month 3|Laboratory chemistry total bilirubin|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.||umol/L||Standard Deviation|Mean
703739|NCT00095498|Secondary|Change From Baseline in Total Bilirubin at Month 1|Laboratory chemistry total bilirubin|baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.||umol/L||Standard Deviation|Mean
703740|NCT00095498|Secondary|Change From Baseline in Bicarbonate at Month 12|Laboratory chemistry bicarbonate|Baseline, Month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.||mmol/L||Standard Deviation|Mean
703741|NCT00095498|Secondary|Change From Baseline in Bicarbonate at Month 6|Laboratory chemistry bicarbonate|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.||mmol/L||Standard Deviation|Mean
703742|NCT00095498|Secondary|Change From Baseline in Bicarbonate at Month 3|Laboratory chemistry bicarbonate|baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.||mmol/L||Standard Deviation|Mean
703743|NCT00095498|Secondary|Change From Baseline in Bicarbonate at Month 1|Laboratory chemistry bicarbonate|baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.||mmol/L||Standard Deviation|Mean
703744|NCT00095498|Secondary|Change From Baseline in Alkaline Phosphatase at Month 12|Laboratory chemistry alkaline phosphatase|baseine, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.||U/L||Standard Deviation|Mean
703745|NCT00095498|Secondary|Change From Baseline in Alkaline Phosphatase at Month 6|Laboratory chemistry alkaline phosphatase|baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.||U/L||Standard Deviation|Mean
703746|NCT00095498|Secondary|Change From Baseline in Alkaline Phosphatase at Month 3|Laboratory chemisrty alkaline phosphatase|baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.||U/L||Standard Deviation|Mean
703747|NCT00095498|Secondary|Change From Baseline in Alkaline Phosphatase at Month 1|Laboratory chemistry alkaline phoshatatse|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.||U/L||Standard Deviation|Mean
703748|NCT00095498|Secondary|Change From Baseline in Albumin at Month 12|Laboratory chemistry albumin|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.||g/L||Standard Deviation|Mean
703749|NCT00095498|Secondary|Change From Baseline in Albumin at Month 6|Laboratory chemistry albumin|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.||g/L||Standard Deviation|Mean
703750|NCT00095498|Secondary|Change From Baseline in Albumin at Month 3|Laboratory chemistry albumin|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.||g/L||Standard Deviation|Mean
703751|NCT00095498|Secondary|Change From Baseline in Albumin at Month 1|Laboratory Chemistry Albumin|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.||g/L||Standard Deviation|Mean
703752|NCT00095498|Secondary|Number of Participants With Anti-Denosumab Binding Antibody and Neutralizing Antibody|Serum from participants testing positive for anti-denosumab binding antibodies was tested in a cell-based bioassay for neutralizing activity against denosumab.|Baseline to Month 12|Patients who were positive for anti-denosumab antibodies||Participants|||Number
703753|NCT00095498|Secondary|Number of Participants With Anti-Denosumab Binding Antibodies|Serum from participants was tested for antibodies to denosumab by immuoassay at months 1, 3, 6 and 12. The number of participants with anti-denosumab antibodies at any assessment is reported.|Assessed at Baseline and at Months 1, 3, 6 and 12.|Patients who received at least 1 dose of investigational product and with at least one postbaseline sample taken.||Participants|||Number
703754|NCT00095498|Secondary|Percent Change From Baseline in Urine Type II C-Tx /Creatinine at Month 12|Percent change from baseline to Month 12 in urine Type II collagen C-Telopeptide (CTX)/Creatinine calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.|Baseline, Month 12|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 12 months.||Percent change from baseline||Inter-Quartile Range|Median
703755|NCT00095498|Secondary|Percent Change From Baseline in Urine Type II C-Tx /Creatinine at Month 6|Percent change from baseline to Month 6 in urine Type II collagen C-Telopeptide (CTX)/Creatinine calculated using ((Month 6 value - Baseline value) / Baseline value ) x 100.|Baseline, Month 6|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 6 months.||Percent change from baseline||Inter-Quartile Range|Median
703756|NCT00095498|Secondary|Percent Change From Baseline in Urine Type II Collagen C-telopeptide (C-Tx) /Creatinine at Month 3|Percent change from baseline to Month 3 in urine Type II collagen C-Telopeptide (CTX)/Creatinine calculated using ((Month 3 value - Baseline value) / Baseline value ) x 100.|Baseline, Month 3|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 3 months.||Percent change from baseline||Inter-Quartile Range|Median
703757|NCT00095498|Secondary|Percent Change From Baseline in P1NP at Month 12|Percent change from baseline to Month 12 in procollagen 1 N-terminal peptide (P1NP) calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.|Baseline, Month 12|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 12 months.||Percent change from baseline||Inter-Quartile Range|Median
703758|NCT00095498|Secondary|Percent Change From Baseline in P1NP at Month 6|Percent change from baseline to Month 6 in procollagen 1 N-terminal peptide (P1NP) calculated using ((Month 6 value - Baseline value) / Baseline value ) x 100.|Baseline, Month 6|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 6 months.||Percent change from baseline||Inter-Quartile Range|Median
703759|NCT00095498|Secondary|Percent Change From Baseline in Procollagen 1 N-terminal Peptide (P1NP) at Month 3|Percent change from baseline to Month 3 in procollagen 1 N-terminal peptide (P1NP) calculated using ((Month 3 value - Baseline value) / Baseline value ) x 100.|Baseline, Month 3|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 3 months.||Percent change from baseline||Inter-Quartile Range|Median
703760|NCT00095498|Secondary|Percent Change From Baseline in Serum CTX at Month 12|Percent change from Baseline to Month 12 in serum C-Telopeptide (CTX) Type I calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.|Baseline, Month 12|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 12 months.||Percent change from baseline||Inter-Quartile Range|Median
703761|NCT00095498|Secondary|Percent Change From Baseline in Serum CTX at Month 6|Percent change from baseline to Month 6 in serum Collagen C-Telopeptide (CTX) Type I calculated using ((Month 6 value - Baseline value) / Baseline value ) x 100.|Baseline, Month 6|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 6 months.||Percent change from baseline||Inter-Quartile Range|Median
703762|NCT00095498|Secondary|Percent Change From Baseline in Serum Collagen C-Telopeptide (CTX) at Month 3|Percent change from baseline to Month 3 in serum Collagen C-Telopeptide (CTX) Type I calculated using ((Month 3 value - Baseline value) / Baseline value ) x 100.|Baseline, Month 3|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 3 months.||Percent change from baseline||Inter-Quartile Range|Median
703763|NCT00095498|Secondary|Percent Change From Baseline in Total Hip Bone Mineral Density at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from baseline to Month 12 calculated using ((Month 12 value - baseline value) / baseline value ) x 100. Least squares means based on repeated measures model adjusting for treatment, visit, baseline value, and strata (4 strata from the combination of baseline use of steroid and previous use of biologic).|Baseline, Month 12|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 12 months.||Percent change from baseline||Standard Error|Least Squares Mean
703764|NCT00095498|Secondary|Percent Change From Baseline in Total Hip Bone Mineral Density at Month 6|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from baseline to Month 6 calculated using ((Month 6 value - baseline value) / baseline value ) x 100. Least squares means based on repeated measures model adjusting for treatment, visit, baseline value, and strata (4 strata from the combination of baseline use of steroid and previous use of biologic).|Baseline, Month 6|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 6 months.||Percent change from baseline||Standard Error|Least Squares Mean
703765|NCT00095498|Secondary|Percent Change From Baseline in Total Hip Bone Mineral Density at Month 1|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from baseline to Month 1 calculated using ((Month 1 value - baseline value) / baseline value ) x 100. Least squares means based on repeated measures model adjusting for treatment, visit, baseline value, and strata (4 strata from the combination of baseline use of steroid and previous use of biologic).|Baseline, Month 1|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 1 month.||Percent change from baseline||Standard Error|Least Squares Mean
703766|NCT00095498|Secondary|Percent Change From Baseline in Femoral Neck Bone Mineral Density at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from baseline to Month 12 calculated using ((Month 12 value - baseline value) / baseline value ) x 100. Least squares means based on repeated measures model adjusting for treatment, visit, baseline value, and strata (4 strata from the combination of baseline use of steroid and previous use of biologic).|Baseline, Month 12|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 12 months.||Percent change from baseline||Standard Error|Least Squares Mean
703871|NCT00096265|Secondary|Quality-adjusted Survival as Measured by EuroQol 5-dimension Instrument|Compared between two treatment arms using a two-group t-test.|From randomization to date of death or last follow-up. Analysis occurs after the primary outcome analysis.||||||
703767|NCT00095498|Secondary|Percent Change From Baseline in Femoral Neck Bone Mineral Density at Month 6|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from baseline to Month 6 calculated using ((Month 6 value - baseline value) / baseline value ) x 100. Least squares means based on repeated measures model adjusting for treatment, visit, baseline value, and strata (4 strata from the combination of baseline use of steroid and previous use of biologic).|Baseline, Month 6|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 6 months.||Percent change from baseline||Standard Error|Least Squares Mean
703768|NCT00095498|Secondary|Percent Change From Baseline in Femoral Neck Bone Mineral Density at Month 1|"Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from baseline to Month 1 calculated using ((Month 1 value - baseline value) / baseline value ) x 100.
Least squares means based on repeated measures model adjusting for treatment, visit, baseline value, and strata (4 strata from the combination of baseline use of steroid and previous use of biologic)."|Baseline, Month 1|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 1 month.||Percent change from baseline||Standard Error|Least Squares Mean
703769|NCT00095498|Secondary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from baseline to Month 12 calculated using ((Month 12 value - baseline value) / baseline value ) x 100. Least squares means based on repeated measures model adjusting for treatment, visit, baseline value, and strata (4 strata from the combination of baseline use of steroid and previous use of biologic).|Baseline, Month 12|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 12 months.||Percent change from baseline||Standard Error|Least Squares Mean
703770|NCT00095498|Secondary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 6|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from baseline to month 6 calculated using ((month 6 value - baseline value) / baseline value ) x 100. Least squares means are based on a repeated measures model adjusting for treatment, visit, baseline value, and strata (4 strata from the combination of baseline use of steroid and previous use of biologic).|Baseline, month 6|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 6 months.||Percent change from baseline||Standard Error|Least Squares Mean
703771|NCT00095498|Secondary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 1|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from baseline to Month 1 calculated using ((month 1 value - baseline value) / baseline value ) x 100. Least squares means are based on a repeated measures model adjusting for treatment, visit, baseline value, and strata (4 strata from the combination of baseline use of steroid and previous use of biologic).|Baseline, Month 1|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 1 month.||Percent change from baseline||Standard Error|Least Squares Mean
703772|NCT00095498|Secondary|Change From Baseline in Radiographic Joint Space Narrowing Score at Month 6|Joint Space Narrowing (JSN) Score summarizes the severity of JSN in 30 joints of the hands and 12 joints of the feet obtained from radiographs of the hands and feet and assessed by 2 independent readers. Assessment of JSN for each hand (15 joints per hand) and foot (6 joints per foot), including subluxation, was scored from 0 (normal JSN) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score (indicating worst joint space narrowing) of 168.|Baseline, Month 6|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 6 months.||units on a scale||Inter-Quartile Range|Median
703773|NCT00095498|Secondary|Change From Baseline in Radiographic Joint Space Narrowing Score at Month 12|Joint Space Narrowing (JSN) Score summarizes the severity of JSN in 30 joints of the hands and 12 joints of the feet obtained from radiographs of the hands and feet and assessed by 2 independent readers. Assessment of JSN for each hand (15 joints per hand) and foot (6 joints per foot), including subluxation, was scored from 0 (normal JSN) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score (indicating worst joint space narrowing) of 168.|Baseline, Month 12|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 12 months.||units on a scale||Inter-Quartile Range|Median
703774|NCT00095498|Secondary|Change From Baseline in Radiographic Erosion Score at Month 6|The joint erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints in the feet, obtained from radiographs of the hands and feet and assessed by 2 independent readers. Each joint was scored, according to the surface area involved, from 0 (no erosion) to 5 (extensive loss of bone from more than one half of the articulating bone). Because each side of a foot joint was graded on this scale, the maximum erosion score for a foot joint was 10 and the maximal erosion score was 280.|Baseline, Month 6|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 6 months.||units on a scale||Inter-Quartile Range|Median
703775|NCT00095498|Secondary|Change From Baseline in Radiographic Erosion Score at Month 12|The joint erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints in the feet, obtained from radiographs of the hands and feet and assessed by 2 independent readers. Each joint was scored, according to the surface area involved, from 0 (no erosion) to 5 (extensive loss of bone from more than one half of the articulating bone). Because each side of a foot joint was graded on this scale, the maximum erosion score for a foot joint was 10 and the maximal erosion score was 280.|Baseline, Month 12|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 12 months.||units on a scale||Inter-Quartile Range|Median
703836|NCT00096044|Secondary|Time to Progression for the Combination Therapy of CC-5013+Rituximab|Progressive disease is defined as reappearance of malignant CLL clone on flow cytometry or by PCR analysis in blood or bone marrow using the 1996 NCI-WF Criteria.|Every month up to 6 months and every 3 months thereafter up to 5 years|All treated with combination therapy of CC-5013+Rituximab and eligible patients||months||95% Confidence Interval|Median
703776|NCT00095498|Secondary|Change From Baseline in Radiographic Total Modified Sharp Score (TSS) at Month 6|TSS is the sum of erosion and joint space narrowing scores obtained from radiographs of the hands and feet, assessed by 2 independent readers. The joint erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints in the feet. Each joint was scored, according to the surface area involved, from 0 (no erosion) to 5 (extensive loss of bone from more than one half of the articulating bone). Because each side of a foot joint was graded on this scale, the maximum erosion score for a foot joint was 10 and the maximal erosion score was 280. Joint Space Narrowing (JSN) Score summarizes the severity of JSN in 30 joints of the hands and 12 joints of the feet. Assessment of JSN for each hand (15 joints per hand) and foot (6 joints per foot), including subluxation, was scored from 0 (normal JSN) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. The TSS ranged from 0 (normal) to 448 (worst).|Baseline, Month 6|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 6 months.||units on a scale||Inter-Quartile Range|Median
703777|NCT00095498|Secondary|Change From Baseline in Radiographic Total Modified Sharp Score (TSS) at Month 12|TSS is the sum of erosion and joint space narrowing scores obtained from radiographs of the hands and feet, assessed by 2 independent readers. The joint erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints in the feet. Each joint was scored, according to the surface area involved, from 0 (no erosion) to 5 (extensive loss of bone from more than one half of the articulating bone). Because each side of a foot joint was graded on this scale, the maximum erosion score for a foot joint was 10 and the maximal erosion score was 280. Joint Space Narrowing (JSN) Score summarizes the severity of JSN in 30 joints of the hands and 12 joints of the feet. Assessment of JSN for each hand (15 joints per hand) and foot (6 joints per foot), including subluxation, was scored from 0 (normal JSN) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. The TSS ranged from 0 (normal) to 448 (worst).|Baseline, Month 12|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 12 months.||units on a scale||Inter-Quartile Range|Median
703778|NCT00095498|Primary|Change From Baseline in Rheumatoid Arthritis Erosion Score Measured From MRI Assessments (RA-MRI ES) at Month 6|Fifteen sites in each wrist and 10 sites in each hand were assessed by a blinded and independent reader. Each site was scored from 0 to 10 (in accordance with the European League Against Rheumatism [EULAR]-Outcome Measures in Rheumatology Clinical Trials convention), with each unit increment representing 10% incremental loss of the peripheral 1 cm of articular bone. The Erosion Score is a sum of erosion scores from 50 joint sites in both hands/wrists and ranges from 0 (normal, no erosion) to 500 (worst possible erosion).|Baseline, Month 6|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 6 months.||units on a scale||Full Range|Median
703779|NCT00095563|Secondary|Most Frequent Adverse Events of Grade 1-2 by CTCAE Grading|Number of participants that experienced the most frequent adverse events of grade 1-2 by CTCAE grading.|Up to 5 years|||participants|||Number
703780|NCT00095563|Secondary|Overall Survival (OS)|Survival estimates will be computed using the Kaplan-Meier method.|From the date of study enrolment to death or last contact, assessed up to 5 years|20 participants with ACC, 19 participants with non-ACC.||months||95% Confidence Interval|Median
703781|NCT00095563|Secondary|Progression-free Survival (PFS) According to RECIST||From the date of study enrolment to disease progression, death or last contact, or last tumor assessment before the start of further anti-tumor therapy, assessed up to 5 years|36 assessable participants, 19 with ACC and 17 with non-ACC.||months||95% Confidence Interval|Median
703782|NCT00095563|Secondary|Rate of Stable Disease|Number of patients who had Stable disease for more than or equal to 6 months together in both Adenoid cystic carcinoma (ACC) and non-adenoid cyctic carcinoma (non-ACC)|6 months|36 assessable participants, 19 with ACC and 17 with non-ACC.||participants|||Number
703783|NCT00095563|Secondary|Duration of Objective Response||From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 5 years|This assessment was not performed since no participants showed a response.|||||
703784|NCT00095563|Primary|Objective Response Rates (Partial and Complete Responses)|Per Response - Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions;|Up to 5 years|36 assessable participants.||participants|||Number
703785|NCT00095576|Primary|HIV-1 Viral Load in Infected Participants|Plasma HIV-1 viral RNA was to be measured using a ribonucleic acid polymerase chain reaction (RNA PCR) on the last archived sample, and at Weeks 1, 2, 8, 12, and 26 post-HIV-1 infection, and subsequently every 6 months.|Day 1 to End of Study (Week 210 for HIV uninfected participants and Week 338 for HIV infected participants)|An interim analysis for this study showed that the MRK Ad5 HIV-1 gag/pol/nef vaccine used in this study was not efficacious; therefore, this outcome measure was not analyzed and only a high level summary of the safety data was performed.|||||
703786|NCT00095576|Primary|Number of Participants With HIV-1 Infections|The number of participants with HIV-1 infections was to be determined with a periodic HIV-1 screening test to detect antibodies to recombinant HIV-1 envelope protein in the participants' serum.|Day 1 to End of Study (Week 210 for HIV uninfected participants and Week 338 for HIV infected participants)|An interim analysis for this study showed that the MRK Ad5 HIV-1 gag/pol/nef vaccine used in this study was not efficacious; therefore, this outcome measure was not analyzed and only a high level summary of the safety data was performed.|||||
703787|NCT00095576|Primary|Number of Participants With Laboratory Adverse Experiences|"Number of participants with laboratory adverse experiences with an incidence cut-off of 5% (events occurring > 5% in at least one treatment group) following administration of the first dose of study vaccine.
Laboratory AEs were based on a grading system considering the severity of abnormal laboratory values in participants and reflect any unfavorable and unintentional change in function, or chemistry of the body.
All laboratory AEs were collected up to 14 days after any vaccine dose."|Day 1 to Week 208|||Participants|||Number
703870|NCT00096265|Secondary|Change in Functional Assessment of Cancer Therapy-Brain Subscale Questionnaire|Compared between two treatment arms using a two-group chi-squared test.|From randomization to three months.||||||
703788|NCT00095576|Primary|Number of Participants With Clinical Adverse Experiences|"Number of participants with non-serious AEs with an incidence cut-off of 5% (>5% in at least one treatment group) and number of participants with >1 SAE following administration of study vaccine.
AEs collected include serious and non-serious systemic AEs, and injection-site AEs. All systemic AEs were collected up to 14 days after any vaccine dose, and serious AEs were collected for the entire study period (up to Week 210).
Injection-site AEs are any swelling, redness, pain or tenderness at the injection site. All injection site AEs were collected up to Day 4 after any vaccine dose."|Day 1 to End of Study (Week 210 for HIV uninfected participants and Week 338 for HIV infected participants)|||Participants|||Number
703789|NCT00095628|Other Pre-specified|1 Year Overall Survival|Overall survival is defined as the time from enrolment until death due to any cause. The Kaplan-Meier method was used to estimate overall survival.|12 months|||percentage of participants||95% Confidence Interval|Number
703790|NCT00095628|Secondary|Median Time to Progression|Time to progression (TTP) is defined as the time from enrolment onto the study until progression or death. The Kaplan-Meier method was used to estimate TTP.|Up to 18 months|||months||95% Confidence Interval|Median
703791|NCT00095628|Secondary|Median Overall Survival of SB-715992|Overall survival is defined as the time from enrolment until death due to any cause. The Kaplan-Meier method was used to estimate overall survival.|Up to 18 months|||months||95% Confidence Interval|Median
703792|NCT00095628|Secondary|Number of Participants With Clinical and Objective Stable Disease|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease.|Up to 18 months|||participants|||Number
703793|NCT00095628|Secondary|Duration of Objective Response|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesion|Up to 18 months|Data were not collected because 0 participants showed a response.|||||
703794|NCT00095628|Primary|Antitumor Activity of SB-715992 Using Objective Response Rates (Partial and Complete Responses)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesion|Up to 18 months|20 eligible patients were analyzed||participants|||Number
703815|NCT00095836|Secondary|Overall Survival|The median overall survival time, measured from the time of enrollment until death.|5 years|||Months||Full Range|Median
703816|NCT00095836|Secondary|Median Progression-free Survival|"The median progression-free survival as assessed by RECIST criteria (Response Evaluation Criteria In Solid Tumors) measured from the time of enrollment until disease progression or death.
Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or the appearance of new lesions."|From the time of enrollment until disease progression or death, whichever came first|||Months||95% Confidence Interval|Median
703817|NCT00095836|Secondary|Toxicity|Drug related toxicity as assessed by NCI CTCAE that occurred in more than 10% of patients|Through study completion, on average 12 months|||participants|||Number
703818|NCT00095836|Primary|Objective Tumor Response Rate at 3, 6, and 12 Months|"Response rate as assessed by Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Tumor assessment is performed within 4 weeks of initiation of treatment and then every 8 weeks. If a patient has stable disease for four tumor assessments (6 months), then tumor assessment may occur every 4 months. If the patient continues to experience stable disease after 2 years, tumor assessments may occur every 6 months. If the patient continues to experience stable disease after 5 years, tumor assessments may occur once a year.
Complete Response (CR): Disappearance of all target lesions
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions
Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions
Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD"|3 Months, 6 Months, 1 Year|Two patients lost to follow-up prior to assessment of tumor response||participants|||Number
703819|NCT00095875|Secondary|Progression-free Survival and Disease-specific Survival as Assessed by Disease Progression or Death and Log Rank Tests at the Median, and 2, 3, and 5 Years|Progression free survival was defined as the time from date of randomisation to disease progression or death from any cause without progression whichever occurred first; otherwise, patients were censored at the date last known to be free of progression.|5 years|||percent of patients||95% Confidence Interval|Number
703820|NCT00095875|Primary|Overall Survival|To compare the 3-year survival achieved by docetaxel/cisplatin/5-FU based sequential therapy with platinum based chemo radiotherapy in patients with locally advanced SCCHN. Overall survival is defined as the time from date of randomisation to death from any cause. Patients alive at the time of current analysis were censored at the date last known to be alive.Kaplan-Meier method was used to estimate overall survival|3-years|||percent of patients||95% Confidence Interval|Number
703821|NCT00095940|Secondary|Number of Participants With Tumors Expressing Phosphorylated ERBB2 (Phase II Objective)|Phosphorylated ERBB2 expression is assessed in patients who provided pre-treatment formalin fixed paraffin embedded tumor material. The tumor material is analyzed by immunohistochemistry for expression of phosphorylated ERBB2. Low, moderate, and intense expression are combined into one group vs. no phosphorylated ERBB2 expression.|Pre-treatment|Participants from the molecular biology trial or the phase II trial who consented to the biology studies and provided pre-treatment formalin fixed paraffin embedded tumor were included in the analysis population.||Participants|||Number
703822|NCT00095940|Secondary|Number of Participants With Tumors Expressing Total ERBB2|Total ERBB2 expression is assessed in participants enrolled in both the molecular biology trial and the phase II trial who provided pre-treatment formalin fixed paraffin embedded tumor material. The tumor material is analyzed by immunohistochemistry for expression of total ERBB2. Low, moderate, and intense expression are combined into one group vs. no total ERBB2 expression.|Pre-treatment|Participants from the molecular biology trial or the phase II trial who consented to the biology studies and provided pre-treatment formalin fixed paraffin embedded tumor were included in the analysis population.||Participants|||Number
703823|NCT00095940|Secondary|Maximum Concentration of Lapatinib in Plasma (Phase II Objective)|Serial plasma samples for pharmacokinetic studies of lapatinib will be collected from consenting participants with the first dose of course 1.|First dose of lapatinib in course 1|The analysis population consists of participants with recurrent medulloblastoma, high grade glioma, or ependymoma who did not have surgical resection of the tumor at study enrollment, consented to the pharmacokinetic studies, and received the first dose of lapatinib in course 1.||nanogram/milliliter||Full Range|Median
703824|NCT00095940|Secondary|Tumor to Plasma Lapatinib Concentration (Molecular Biology Objective)|For participants randomized to receive lapatinib 7-14 days prior to surgery, plasma samples will be obtained with the first dose of lapatinib prior to surgery. The lapatinib concentration is measured in both the plasma samples and the tumor tissue obtained at surgery. Reported is the concentration of lapatinib observed in the tumor expressed as a percentage of the concentration observed in plasma.|First dose of lapatinib prior to surgery|The analysis population consists of recurrent medulloblastoma, high grade glioma, or ependymoma patients who were randomized to receive lapatinib prior to surgery, consented to the pharmacokinetic studies and received dose 1 of lapatinib.||percent||Full Range|Median
703825|NCT00095940|Primary|Number of Participants With a Sustained Objective Response (Complete or Partial Response) (Phase II Objective)|A complete response is defined as complete disappearance of all tumor accompanied by a stable or improving neurologic exam, and a partial response is defined as 50% or more reduction in the tumor size by bi-dimensional measurement and a stable or improving neurologic exam. The response must be sustained for at least 8 weeks. The number of patients with a sustained objective response will be reported separately for each of the three disease groups.|From start of therapy until the earliest of disease progression, death or end of the fourth course (recurrent medulloblastoma and recurrent high grade glioma) or end of the sixth course (recurrent ependymoma)|Participants with measureable residual disease who do not receive lapatinib prior to surgery or who do not have surgical resection of the tumor at study enrollment will be assessed for sustained objective response. Participants must have received at least one dose of lapatinib and remain on treatment for the specified time frame to be evaluable.||Participants|||Number
703826|NCT00095940|Primary|Relative Phosphorylation of ERBB2 (Molecular Biology Objective)|Lapatinib may be able to control the growth of tumor cells. To assess the ability of lapatinib to block a molecule, the ERBB2 receptor, that signals tumor cells to divide, fresh frozen tissue from the surgical resection is processed by quantitative western blot analysis to assess the phosphorylation of ERBB2. The relative phosphorylation is a ratio of the phosphorylated ERBB2 measured in the tumor normalized to the level of total receptor protein and housekeeping protein. Lower values suggests more inhibition of the ERRB2 receptor signal and a decreased ability for tumor cell division.|7-14 days after starting therapy and prior to surgery|Participants enrolled on the molecular biology phase (MBP) and who submitted fresh frozen tissue were included in the analysis for this objective. One patient enrolled on the MBP did not provide fresh frozen tissue and was excluded. The sample size required for this objective was not met.||ratio||Full Range|Median
703827|NCT00095979|Secondary|Overall Survival|Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.|From study entry to death or last contact, up to 5 years of follow-up.|Eligible and treated patients||months||95% Confidence Interval|Median
703828|NCT00095979|Secondary|Progression-free Survival|Progression-Free Survival is the period from study entry until disease progression, death or date of last contact, whichever occurs first.|From study entry to disease progression, death or date of last contact, whichever occurs first, up to 5 years of follow-up.|Eligible and Treated Patients||months||95% Confidence Interval|Median
703829|NCT00095979|Primary|Frequency and Severity of Observed Adverse Effects||Every cycle until completion of study treatment up to 30 days after stopping study treatment||||||
703830|NCT00095979|Primary|Tumor Response|Complete and Partial Tumor Response as assessed by the Gynecologic Oncology Group Response Evaluation Criteria in Solid Tumors (GOG RECIST)|Every other cycle for first 6 months; then every six months thereafter until completion of study treatment; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease|Eligible and Treated Patients||percentage of participants||90% Confidence Interval|Number
703831|NCT00096018|Primary|Duration of Response||4 weeks, every 3 months for 2 years, and then every 4 months for 2 years|Patients with Complete or Partial Response||months||Standard Deviation|Mean
703832|NCT00096018|Primary|Overall Responders (Complete and Partial Response)|Criteria for response were based on the Revised National Cancer Institute-sponsored Working Group Guidelines for response, which includes clinical, hematologic, and bone marrow features (Cheson, B.D., et al., National Cancer Institute-sponsored Working Group guidelines for chronic lymphocytic leukemia: revised guidelines for diagnosis and treatment. Blood. 1996;87:4990-97.)|4 weeks, every 3 months for 2 years, and then every 4 months for 2 years|All Treated Patients||participants|||Number
703833|NCT00096031|Secondary|Time to Progression||every 3 weeks while on treatment, then every 3 months for 3 years|||months||95% Confidence Interval|Median
703834|NCT00096031|Secondary|Time to Treatment Failure||every 3 weeks while on treatment|||months||95% Confidence Interval|Median
703835|NCT00096031|Primary|Overall Survival at 6 Months||every 3 weeks while on treatment, then every 3 months|||percentage of participants||95% Confidence Interval|Number
703837|NCT00096044|Secondary|Time to Progression for Single Agent CC-5013|Progressive disease is defined as reappearance of malignant CLL clone on flow cytometry or by PCR analysis in blood or bone marrow using the 1996 NCI-WF Criteria.|5 years|All treated and eligible patients||months||95% Confidence Interval|Median
703838|NCT00096044|Secondary|Number of Participants With Adverse Events on Combination Therapy of CC-5013+Rituximab|Number of Participants with Adverse Events on Combination Therapy of CC-5013+Rituximab, Graded According to NCI CTCAE Version 3.0|Up to 30 days from last date of institution of combination therapy of CC-5013+Rituximab.|All treated with combination therapy of CC-5013+Rituximab and eligible patients||Participants|||Count of Participants
703839|NCT00096044|Secondary|Number of Participants With Adverse Events on Single Agent CC-5013|"Number of Participants with Adverse Events on Single Agent CC-5013, Graded According to NCI CTCAE Version 3.0
Please refer to the adverse event reporting for more detail."|1 year|All treated and eligible patients||Participants|||Count of Participants
703840|NCT00096044|Secondary|Percentage of Patients Achieving a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) on Combination Therapy of CC-5013+Rituximab|Percentage of patients achieving CR, PR or maintaining SD using the 1996 NCI-WF Criteria. CR: absence of lymph nodes and constitutional symptoms; no hepatomegaly or splenomegaly by physical examination; neutrophil count >1500/μL; platelet count >100,000/μL; untransfused hemoglobin concentration >11.0g/dL; lymphocyte count <4000/μL; bone marrow sample must be at least normocellular for age; with less than 30% of nucleated cells being lymphocytes and no lymphoid nodules. PR: ≥50% decrease in lymphocyte count from baseline; ≥50% reduction in lymph nodes from baseline; ≥50% reduction in the size of the liver/spleen from baseline; neutrophil count ≥1500/μL or ≥50% improvement from baseline; platelet count ≥100,000/μL or ≥50% improvement from baseline; untransfused hemoglobin concentration ≥11.0g/dL or ≥50% improvement from baseline. Patients who have not exhibited as reappearance of malignant CLL clone on flow cytometry or by PCR analysis in blood or bone marrow, are considered to have SD.|5 years|All treated with combination therapy of CC-5013+Rituximab and eligible patients||percentage of participants||95% Confidence Interval|Number
703841|NCT00096044|Primary|Percentage of Patients Achieving a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) on Single Agent CC-5013 at 6 Months|Percentage of patients achieving CR, PR or maintaining SD using the 1996 NCI-WF Criteria. CR: absence of lymph nodes and constitutional symptoms; no hepatomegaly or splenomegaly by physical examination; neutrophil count >1500/μL; platelet count >100,000/μL; untransfused hemoglobin concentration >11.0g/dL; lymphocyte count <4000/μL; bone marrow sample must be at least normocellular for age; with less than 30% of nucleated cells being lymphocytes and no lymphoid nodules. PR: ≥50% decrease in lymphocyte count from baseline; ≥50% reduction in lymph nodes from baseline; ≥50% reduction in the size of the liver/spleen from baseline; neutrophil count ≥1500/μL or ≥50% improvement from baseline; platelet count ≥100,000/μL or ≥50% improvement from baseline; untransfused hemoglobin concentration ≥11.0g/dL or ≥50% improvement from baseline. Patients have not exhibited as reappearance of malignant CLL clone on flow cytometry or by PCR analysis in blood or bone marrow, are considered to have SD.|at 6 Months|All treated and eligible patients||percentage of participants||95% Confidence Interval|Number
703842|NCT00096109|Primary|Her2/Neu Status|"Response rates will be estimated separately for her2/neu positive and her2/neu negative individuals along with 95% confidence intervals.
PLEASE NOTE: IT WAS PROPOSED TO ANALYZE OUTCOME BY HER2 STATUS, NO DATA WAS COLLECTED OR EVALUATED."|Baseline|No participants were evaluated for her2/neu status.|||||
703843|NCT00096109|Primary|Progression Free Survival (PFS)|PFS is defined as either progression or death, whichever occurs first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Up to 7 years|||months||95% Confidence Interval|Median
703844|NCT00096109|Primary|Response Rate (Complete Response (CR) +Partial Response (PR)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 7 years|||Participants|||Count of Participants
703845|NCT00096122|Primary|Number of Participants With Complete Response|Complete Response (CR) is required bone marrow blasts ≤5% and recovery of normal hematopoiesis with an absolute neutrophil count (ANC) of 1*10^9/L or more and platelet count of 100*10^9/L or more; and a complete response without platelets (CRp) is the same criteria as CR but with platelet counts from 20*10^9/L to less than 100*10^9/L.|21 Day Cycle|Analysis was per protocol.||Participants|||Number
703846|NCT00096135|Primary|Event-free Survival|Monitoring of efficacy results will be performed in comparison with historical results.|3 years|The CNS-treatment cohort includes 126 patients with 120 CNS pre-B, 2 CNS+ITR pre-B and 4 T-AL. The primary analysis was restricted to CNS pre-B and ITR pre-B patients, respectively. Both CNS+ITR and T-ALL patients had to be excluded from the primary analysis. That is how we came to 120 in the CNS-treatment cohort for outcome analysis.||percentage of participants|||Number
703847|NCT00096161|Secondary|Survival|Percentage patients surviving.|1 year after DLI|||percentage of participants|||Number
703848|NCT00096161|Secondary|Incidence of Relapse/Progression|"CML Acquisition of a new cytogenetic abnormality and/or development of accelerated phase or blast crisis. Criteria for accelerated phase: unexplained fever >38.3° C, new clonal cytogenetic abnormalities in addition to a single Ph-positive chromosome, BM blasts and promyelocytes >20%.
AML, ALL, CMML >30% BM blasts w/ deteriorating performance status, or worsening of anemia, neutropenia, or thrombocytopenia.
CLL Progressive disease: ≥1 of: physical exam/imaging studies (nodes, liver, and/or spleen) ≥50% increase or new, circulating lymphocytes by morphology and/or flow cytometry ≥50% increase, and lymph node biopsy w/ Richter’s transformation.
NHL >25% increase in the sum of the products of the perpendicular diameters of marker lesions, or the appearance of new lesions.
MM
≥100% increase of the serum myeloma protein from its lowest level, or reappearance of myeloma peaks that had disappeared w/ tx; or definite increase in the size/number of plasmacytomas or lytic bone lesions."|1 year after DLI|||percentage of participants|||Number
703849|NCT00096161|Secondary|Incidence of Infections||100 days after DLI|||percentage of participants|||Number
703850|NCT00096161|Secondary|Incidence of GVHD|"Percentage patients with acute or chronic GVHD.
The diagnosis of chronic GVHD requires at least one manifestation that is distinctive for chronic GVHD as opposed to acute GVHD. In all cases, infection and others causes must be ruled out in the differential diagnosis of chronic GVHD."|1 year after DLI|||percentage of participants|||Number
703851|NCT00096161|Primary|Incidence of Grade IV Acute GVHD|"Clinical Stage of acute GVHD according to Organ System
Skin:
- Maculopapular rash <25% of body surface
- Maculopapular rash 25-50% of body surface
- Maculopapular rash >50% body surface area or generalized erythroderma
- Generalized erythroderma with bullous formation and desquamation
Liver:
- Bilirubin 2-3 mg/dl
- Bilirubin 3.1-6 mg/dl
- Bilirubin 6.1-15 mg/dl
- Bilirubin >15 mg/dl
Gut:
- >500-1000 mL diarrhea per day or (nausea, anorexia or vomiting with biopsy (EGD) confirmation of upper GI GVHD
- >1000 -1500 mL diarrhea per day
- >1500 mL diarrhea per day
- >1500 mL diarrhea per day plus severe abdominal pain with or without ileus
Overall Clinical Grading of Severity of acute GVHD Grade IV: 0-4 Skin, 2-4 Liver, and/or 2-4 GI"|Within 100 days after the last DLI|||percentage of participants|||Number
703852|NCT00096161|Primary|Percentage Patients With an Increase of at Least 10 Percentage Points in Donor T-cell Chimerism|"A regimen will be considered successful if 20 patients are enrolled, at least 13 demonstrate improved chimerism. If fewer than 5 patients have shown improvement in chimerism then it can be at least 75% confident that the true rate of improvement is less than 0.53. Enrollment to the regimen will stop and the next regimen will be opened. Enrollment to a regimen may also be stopped at any time it becomes impossible to achieve 5 of 10 or 13 of 20 successful improvements.
“Chimerism” in hematopoietic cell transplant derives from this idea of a “mixed” entity, referring to someone who has received a transplant of genetically different tissue. A test for chimerism after a hematopoietic cell transplant involves identifying the genetic profiles of the recipient and of the donor and then evaluating the extent of mixture in the recipient’s blood cells or marrow cells."|From the time of enrollment maintained to day 56 after the last DLI, up to Day 112|||percentage of participants|||Number
703853|NCT00096174|Secondary|Overall Response Rate|Response was assessed per Response Evaluation in Solid Tumor (RECIST) criteria by physical assessment and CT. Overall response = complete response (CR) + partial response (PR). CR was defined as the disappearance of all target and non-target lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters of target lesions, along with non-progressive disease of non-target lesions. Overall response rate (i.e., proportion of patients who had CR or PR) and the corresponding 90% confidence intervals were calculated for the 60 eligible and treated patients|assessed after all chemoradiation therapy completed Week 9, then every 3 months on C225 maintenance therapy, and every 3 months for 2 years, every 6 months post-treatment 2 years from study entry|Eligible and treated||proportion of participants||90% Confidence Interval|Number
703854|NCT00096174|Secondary|2-year Overall Survival Rate|Overall survival was defined as time from registration to death from any cause. Patients alive at last follow-up were censored. The 2-year overall survival rate was defined as the percentage of patients that were still alive two years after registration into the study. Kaplan-Meier estimate of 2-year overall survival was calculated in the 60 eligible and treated patients.|assessed very 3 months for 2 years|Eligible and treated||proportion of participants||95% Confidence Interval|Number
703855|NCT00096174|Primary|2-year Progression-free Survival Rate|Two-year progression-free survival rate was defined as the proportion of patients that were alive progression-free two years after registration into the study. Disease progression was assessed per modified RECIST criteria, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, in either primary or nodal lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of new lesions. Kaplan-Meier estimate of 2-year progression-free survival was calculated in the 60 eligible and treated patients.|assessed every 3 months for 2 years|Eligible and treated||proportion of participants||95% Confidence Interval|Number
703856|NCT00096200|Secondary|Overall Survival|Overall survival time is calculated from the date of treatment to date of death, and to date of last follow-up for those still alive.|2 years||||||
703857|NCT00096200|Secondary|Evaluate the Progression-free Survival Rate|At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|every 2 cycles (6 weeks)||||||
703858|NCT00096200|Primary|Complete and Partial Response Rate Using the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria|Patients should be reevaluated for response every 2 cycles (6 weeks). Patients who continue on Arm A of treatment for more than 12 months should be reevaluated for response every 3 cycles (9 weeks). In addition to a baseline scan, confirmatory scans should also be obtained 4 weeks following initial documentation of objective response.|after 6 weeks (2 cycles)|Patients that received 2 cycles of treatment. Includes results from patients that crossed over to Arm C.||participants|||Number
703859|NCT00096226|Secondary|Toxicity||From start of treatment to end of follow-up||||||
703860|NCT00096226|Secondary|Progression-free Survival||From registration to two years||||||
703861|NCT00096226|Secondary|Overall Survival||From registration to two years||||||
703862|NCT00096226|Secondary|Rates of R0, R1, and R2 Resections After Chemotherapy||At completion of concurrent chemotherapy and radiation therapy||||||
703863|NCT00096226|Secondary|Rate of Resectability After Chemotherapy||At completion of concurrent chemotherapy and radiation therapy||||||
703864|NCT00096226|Secondary|Rate of Major Morbidities Within 30 Days of Surgery||From date of surgery to 30 days following the date of surgery||||||
703865|NCT00096226|Secondary|Rate of Complete Pathological Response After Concurrent Chemotherapy and Radiation Therapy||At completion of concurrent chemotherapy and radiation therapy||||||
703866|NCT00096226|Primary|Mediastinal Nodal Clearance Rate|If at least 12 of the first 21 evaluable patients and at least 27 of the the first 45 evaluable patients have mediastinal nodal clearance (MNC), then a conclusion of a 70% MNC rate (compared to 50%) is made using Simon's two-stage design with 90% power and 10% type I error.|At completion of concurrent chemotherapy and radiation therapy, up to 14 weeks.|Eligible patients who started protocol treatment and had adequate pathologic information of mediastinal nodal status.||participants|||Number
703867|NCT00096265|Secondary|Cause of Death (Neurologic vs Other)|Compared between two arms using a two-group chi-squared test. Summarized in a 2x2 frequency table.|From randomization to date of death.||||||
703868|NCT00096265|Secondary|Change in Steroid Dependence|Compared between two treatment arms using a two-group chi-squared test.|From randomization to six months.||||||
703869|NCT00096265|Secondary|Change in Performance Status|Compared between two treatment arms using a two-group chi-squared test.|From randomization to six months.||||||
703872|NCT00096265|Secondary|Time to CNS Progression|CNS progression will be defined as any increase in perpendicular bi-dimensional tumor area for any of the 1-3 tracked brain metastases, by any amount, or the appearance of any new brain metastasis on a follow-up MRI (SRS planning scan will not be used to evaluate CNS progression).|From the date of randomization to date of progression, death, or last follow-up. Analysis occurs at the same time as the primary outcome analysis.||||||
703873|NCT00096265|Primary|Overall Survival|Survival time is defined as time from randomization to date of death from any cause and estimated by the Kaplan-Meier method. Patients last known to be alive are censored at date of last contact.|From randomizaton to date of death for last follow-up. Analysis occurs after all patients have been potentiall followed for 9 months.|All eligible patients.||months||95% Confidence Interval|Median
703874|NCT00096278|Secondary|Bevacizumab Immunogenicity and Post-treatment Serum Levels of Bevacizumab in Patients Receiving Bevacizumab||Group 2: Pre-therapy, every 2 weeks during chemotherapy/bevacizumab therapy, every 6 weeks during bevacizumab therapy and at 3 and 6 months after completion of bevacizumab therapy||||||
703875|NCT00096278|Secondary|Ovarian Function in Premenopausal Women as Measured by Serum Ovarian Function Test||Group 2: Measured pre-therapy and then every 6 months for 2 years following randomization||||||
703876|NCT00096278|Secondary|Delayed Vascular Events Such as Myocardial Infarction, Central Nervous System (CNS) Ischemia, and Thrombosis in Patients Receiving Chemotherapy + Bevacizumab||Events measured regularly during chemotherapy and bevacizumab therapy||||||
703877|NCT00096278|Secondary|As Measured by Blood Pressure and Antihypertensive Medication Hypertension||Group 2, every 3 months for one year post treatment||||||
703878|NCT00096278|Secondary|The Risk Factors for Development of Proteinuria||For Groups 1 and 2 at the end of every 3 cycles of chemotherapy plus or minus bevacizumab; for Group 2 patients, every 6 weeks for 6 months. If UPC ratio is greater than or equal to 1.0 at the end of therapy then test every 3 months for 12 months||||||
703879|NCT00096278|Secondary|Proteinuria With Clinical Sequelae||For Groups 1 and 2 at the end of every 3 cycles of chemotherapy plus or minus bevacizumab; for Group 2 patients, every 6 weeks for 6 months. If UPC ratio is greater than or equal to 1.0 at the end of therapy then test every 3 months for 12 months||||||
703880|NCT00096278|Secondary|Proteinuria After Completion of Bevacizumab||For Groups 1 and 2 at the end of every 3 cycles of chemotherapy plus or minus bevacizumab; for Group 2 patients, every 6 weeks for 6 months. If UPC ratio is greater than or equal to 1.0 at the end of therapy then test every 3 months for 12 months||||||
703881|NCT00096278|Secondary|Survival as Assessed by Death From Any Cause||Every 6 months for 4 years and then every 12 months until death from any cause||||||
703882|NCT00096278|Primary|Disease-free Survival|Where events are defined as recurrence, second primary cancer, or death from any cause|3 years|||percentage of patients|||Number
703883|NCT00096356|Secondary|Effects of Coenzyme Q10 on Depression (as Measured by CES-D Short-form) 24 Weeks Following Randomization|CES-D is the Center for Epidemiologic Studies Depression Form. It consists of 20 questions. The total score ranges from 0 to 60. Higher scores indicate greater depression.|24 weeks|||units on a scale||Standard Error|Least Squares Mean
703884|NCT00096356|Secondary|Effects of Coenzyme Q10 on Quality of Life (as Measured by FACT-B) 24 Weeks Following Randomization|FACT-B stands for Functional Assessment of Cancer Therapy - Breast. It measures quality of life. It is the total of the FACT subscales (emotional, social, functional, and physical) and the Breast subscale. Scores range from 0 to 144; higher scores reflect better overall quality of life.|24 weeks|||units on a scale||Standard Error|Least Squares Mean
703885|NCT00096356|Primary|Effects of Coenzyme Q10 on Fatigue (as Measured by POMS-F) 24 Weeks Following Randomization|POMS-F is the Profile of Mood States - fatigue scale. It ranges from 0 to 28; higher values indicate greater fatigue.|24 weeks|||units on a scale||Standard Error|Least Squares Mean
703886|NCT00096382|Primary|Safety|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|4 years|||Participants|||Number
703887|NCT00096382|Primary|Clinical Tumor Regression|Tumor regression is defined as a complete response (CR) or partial response (PR) and was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is the disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.|Every 4-6 weeks for up to 1 year, and then every 6 months for up to 5 years.|||Participants|||Number
703888|NCT00096447|Secondary|Prognostic Factors (Initial Performance Status and Histological Grade)||Up to 6 years||||||
703889|NCT00096447|Secondary|Overall Survival|The observed length of life from entry into the study to death or the date of last contact.|From study entry to death or last contact, up to 5 years.|Eligible and treated patients.||Months||95% Confidence Interval|Median
703890|NCT00096447|Secondary|Duration of Progression-free Survival|Conducted against the historical controls using a proportional hazards model that includes histological grade, performance status, and platinum sensitivity.|From study entry until disease recurrence, death, or date of last contact, assessed up to 5 years||||||
703891|NCT00096447|Secondary|Percentage of Patients With Tumor Response|Complete and Partial Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|For those patients whose disease can be evaluated by physical examination, response was assessed prior to each 28-day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle, for up to 5 years.|Eligible and treated patients.||percentage of participants||90% Confidence Interval|Number
703892|NCT00096447|Primary|Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0|The frequency and severity of all toxicities are tabulated.|Up to 5 years||||||
703906|NCT00096785|Secondary|Viral Load Undetectable (HBV DNA <300 Copies/mL)|Number of Subjects with HBV DNA <300 copies/mL by Roche COBAS® Amplicor (limit of quantitation 300 copies/mL)|Week 48|Treated participants who had both baseline and Week 12 HBV DNA measurements and who received the randomized treatment. 1 participant randomized to ADV actually received ETV and is not counted in secondary efficacy analyses.||Participants|||Number
703893|NCT00096447|Primary|Percentage of Patients With Progression-free Survival > 6 Months|Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.|For those patients whose disease can be evaluated by physical examination, progression was assessed prior to each 28-day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle, for up to 5 years.|Eligible and treated patients.||percentage of participants||90% Confidence Interval|Number
703894|NCT00096460|Primary|Lymphoma Progression-free Survival||Three years post-Hematopoietic Stem Cell Transplant (HSCT)|||participants|||Number
703895|NCT00096486|Primary|Overall Objective Response|Determine efficacy of the combination oral daily gefitinib and oral daily RAD001 in patients with advanced NSCLC. Response and progression will be evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST).|2 years|||participants|||Number
703896|NCT00096538|Primary|Tumor Response Rate Every 4 Weeks||2 years|||participants|||Number
703897|NCT00096681|Secondary|Number of Participants With a Positive HIV Test|Prevalence of HIV in the community based on a positive oral mucosal transudate sample obtained at the once off study visit.|HIV status at the time of the study visit|||Participants|||Number
703898|NCT00096681|Primary|Number of Participants With Microbiologically Confirmed Pulmonary Tuberculosis|Confirmed Pulmonary Tuberculosis based on the sputum smear and culture results. The sputum sample was obtained at the once off study visit.|Pulmonary Tuberculosis diagnosed from sputum sample obtained at the study visit|||Participants|||Number
703899|NCT00096785|Secondary|Summary of Safety - Laboratory Abnormalities Reported as Clinical AEs|Laboratory abnormalities reported as clinical AEs|Week 48|As-treated population. 1 participant who was randomized to ADV, but treated with ETV was counted in the ETV group.||Participants|||Number
703900|NCT00096785|Secondary|Summary of Safety - Most Frequent (> 10%) Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Deaths|AE=new untoward medical occurrence or worsening of pre-existing medical condition regardless of causal relationship to treatment. SAE=untoward medical occurrence that is life-threatening, a congenital anomaly/birth defect, or an important medical event, or results in death, inpatient hospitalization/prolongation of hospitalization, or persistent/significant disability. AE grades: mild (1), moderate (2), severe (3), life-threatening (4), death (5). ALT flare= >2x baseline & >10x ULN up to end of therapy + 5 days. Hepatic SAE=SAEs consistent with worsening of hepatitis or hepatic decompensation.|cumulative through the end of on-treatment observation as available at the time of the Week 48 dataset|As-treated population. 1 participant was randomized to ADV, but treated with ETV was counted in the ETV group.||Participants|||Number
703901|NCT00096785|Secondary|HBV DNA Viral Kinetics - Spline Model|This analysis uses a 3-parameter piece-wise linear model and describes the biphasic decline in HBV DNA (measured by PCR assay) through Week 12. The 3 parameters are the values for the 2 slopes, describing the first and second phase declines, respectively, and the estimated HBV DNA at the knot (at day 10; the time point where the 2 phases join). The biphasic viral decay kinetics for each treatment were obtained using a spline fitting procedure to estimate the 3 parameters for each subject; these estimates were then averaged within each treatment group.|Week 12|Treated subjects who had both baseline and Week 12 HBV DNA measurements and who received the randomized treatment. 1 participant randomized to ADV actually received ETV and is not counted in secondary efficacy analyses.||log10 copies/mL|||Number
703902|NCT00096785|Secondary|HBV DNA Viral Kinetics Estimates of Exponential Decay Model - Half-Life of Free Virus|The biphasic decline of HBV DNA is characterized via a 4-parameter exponential decay model previously published for HBV compounds. An important derived parameter is the half-life of free virus (ie, the average amount of time for HBV particles in plasma to be reduced to half the initial level), calculated as 24*ln(2)/c. The model parameters reflect the biphasic pattern that is typically observed after initiation of antiviral therapy. Parameters were estimated for each subject separately and then averaged within each treatment group.|Week 12|Treated subjects who had both baseline and Week 12 HBV DNA measurements and who received the randomized treatment. 1 participant randomized to ADV actually received ETV and is not counted in secondary efficacy analyses.||hours|||Number
703903|NCT00096785|Secondary|HBV DNA Viral Kinetics Estimates of Exponential Decay Model - Viral Clearance Rate and Infected Cell Death Rate|The biphasic decline of HBV DNA is characterized via a 4-parameter exponential decay model previously published for HBV compounds. The model parameters of interest are the clearance rate of the free virus (c), the death rate of productively infected cells (δ), The model parameters reflect the biphasic pattern that is typically observed after initiation of antiviral therapy. Parameters were estimated for each subject separately and then averaged within each treatment group.|Week 12|Treated subjects who had both baseline and Week 12 HBV DNA measurements and who received the randomized treatment. 1 participant randomized to ADV actually received ETV and is not counted in secondary efficacy analyses.||per day|||Number
703904|NCT00096785|Secondary|HBV DNA Viral Kinetics Estimates of Exponential Decay Model - Efficacy in Blocking Virus Production and de Novo Infections|The biphasic decline of HBV DNA is characterized via a 4-parameter exponential decay model previously published for HBV compounds. The model parameters of interest are the effectiveness of the drug in blocking virus production from infected cells (efficacy, ε) and effectiveness of the study treatment in blocking de novo infection of susceptible cells (η). The model parameters reflect the biphasic pattern that is typically observed after initiation of antiviral therapy. Parameters were estimated for each subject separately and then averaged within each treatment group.|Week 12|Treated subjects who had both baseline and Week 12 HBV DNA measurements and who received the randomized treatment. 1 participant randomized to ADV actually received ETV and is not counted in secondary efficacy analyses.||percent effective|||Number
703905|NCT00096785|Secondary|Alanine Aminotransferase (ALT) Normalization|Number of participants with ALT ≤ 1 x upper limit of normal (ULN)|Week 48|treated subjects who had both baseline and Week 12 HBV DNA measurements and who received the randomized treatment. 1 participant randomized to ADV actually received ETV and is not counted in secondary efficacy analyses.||participants|||Number
707404|NCT00122447|Secondary|AIM 1: Change in hsCRP (High Sensitivity C-reactive Peptide) Level|Inflammatory marker|12 months of intervention|Based on the number of subjects who completed 12 months of intervention and testing||mg/L||Standard Error|Mean
703907|NCT00096785|Secondary|Change From Baseline in HBV DNA by PCR Assay at Week 48|Antiviral efficacy, as measured by the mean reduction in serum HBV DNA levels by PCR (log10 copies/mL) at Week 48, adjusted for baseline (Week 48 - Baseline). A negative value = improvement.|Baseline, Week 48|Treated subjects who had both baseline and Week 12 HBV DNA measurements and who received the randomized treatment. 1 participant randomized to ADV actually received ETV and is not counted in secondary efficacy analyses.||log10 c/mL||Standard Error|Mean
703908|NCT00096785|Primary|Change From Baseline in Hepatitis B Virus DNA (HBV DNA) by Polymerase Chain Reaction (PCR) Assay at Week 12|Antiviral efficacy, as measured by the mean reduction in serum HBV DNA levels by PCR (log10 copies/mL) at Week 12, adjusted for baseline (Week 12 - baseline). A negative value = improvement.|Baseline, Week 12|As-randomized participants who completed 12 weeks of treatment||log10 copies/mL||Standard Error|Mean
703909|NCT00096941|Secondary|Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)|A best overall response could occur at any time during the study and was determined by Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all target lesions (TL) or the disappearance of all non-TLs and normalization of tumor marker level. A PR was defined as at least a 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD. SD was defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since the treatment started for TLs and the persistence of 1 or more non-TL(s) and/or the maintenance of tumor marker level above normal limits. PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started or the appearance of one or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs.|Baseline to the end of the study (up to 2 years, 5 months)|Safety population: Participants who received at least 1 dose of pertuzumab.||percentage of participants|||Number
703910|NCT00096941|Primary|Percentage of Participants Who Experienced an Adverse Event||Baseline to the end of the study (up to 2 years, 5 months)|Safety population: Participants who received at least 1 dose of pertuzumab. Percentage of participants||percentage of participants|||Number
703911|NCT00096954|Secondary|Relative Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 24|"Spirometry was used to assess FEV1. All spirometry measurements were performed in accordance with the American Thoracic Society (ATS) guidelines.
The relative percent change from baseline in forced expiratory volume (liters) in one second (FEV1) was calculated at week 24 using the formula: (FEV1 at week 24 - FEV1 at baseline) / FEV1 at baseline * 100 for each treatment group."|Baseline and 24 weeks|Modified Intent-to-Treat. Patients with missing FEV1 data at either baseline or week 24 were excluded.||percent change||Standard Deviation|Mean
703912|NCT00096954|Secondary|Change From Baseline in Nocturnal and Daytime Asthma Symptom Scores at Week 24|"The daytime asthma symptom score assessed the symptoms: shortness of breath, chest discomfort, wheezing, and cough over the previous 24 hour period on a scale of 0(no symptoms) to 4(marked discomfort).
The nocturnal asthma score was the patient's response to:How did you sleep last night? rated on a scale of 0(no problems) to 4(difficulty sleeping;rescue medicine used).
Scores were collected daily. Change from Baseline (mean of last 28 days prior to first dosing date) at Week 24 (mean of last 28 days prior to week 24 visit).
A negative change from baseline score indicates improvement."|Baseline and 24 weeks|Modified Intent-to-Treat. Patients with missing Asthma Symptom Score data at week 24 were excluded.||score on a scale||Standard Deviation|Mean
703913|NCT00096954|Secondary|Number of Participants Experiencing One or More Protocol-defined Asthma Exacerbations During the Treatment Period|The number of patients reporting one or more protocol-defined asthma exacerbations during the 24 week treatment period. A protocol-defined asthma exacerbation was a worsening of asthma requiring treatment with oral or intravenous corticosteroid burst and/or a doubling of the baseline inhaled corticosteroids (ICS) dose for at least 3 days.|Start of treatment to 24 weeks|Modified Intent-to-Treat - All randomly assigned patients who received at least 1 dose of study drug (omalizumab or placebo).||participants|||Number
703914|NCT00096954|Primary|Rate of Asthma Exacerbations Over the 24 Week Treatment Period|"A protocol-defined asthma exacerbation was a worsening of asthma requiring treatment with oral or intravenous corticosteroid burst and/or a doubling of the baseline inhaled corticosteroids (ICS) dose for at least 3 days.
The rate of protocol-defined asthma exacerbations, normalized by subject-time at risk and computed over the 24 week treatment period in each treatment group."|Start of treatment to 24 weeks|Modified Intent-to-Treat - All randomly assigned patients who received at least 1 dose of study drug (omalizumab or placebo).||exacerbations per 24 patient-week period|||Number
703915|NCT00096993|Secondary|Duration of Survival|Duration of survival was defined as the time from randomization until death from any cause.|Baseline to the end of the study (up to 1 year)|Efficacy-evaluable population: All randomized participants who received at least 1 dose of study medication.||months||95% Confidence Interval|Median
703916|NCT00096993|Secondary|Percentage of Participants Free From Disease Progression at 4 Months|Disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.|Baseline to Month 4|Efficacy-evaluable population: All randomized participants who received at least 1 dose of study medication.||percentage of participants|||Number
703917|NCT00096993|Secondary|Duration of the Objective Response|Duration of the objective response was defined as the time from the initial response to disease progression or death from any cause.|Baseline to the end of the study (up to 1 year)|Efficacy-evaluable population: All randomized participants who received at least 1 dose of study medication. Only participants with an objective response were included in the analysis.||months||95% Confidence Interval|Median
703918|NCT00096993|Secondary|Percentage of Participants With an Objective Response|An objective response was defined as a complete or partial response determined on two consecutive occasions ≥ 4 weeks apart. Responses were determined by Response Evaluation Criteria in Solid Tumors (RECIST). A complete response was defined as the disappearance of all target lesions or the disappearance of all non-target lesions and normalization of tumor marker level. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameter of target lesions.|Baseline to the end of the study (up to 1 year)|Efficacy-evaluable population: All randomized participants who received at least 1 dose of study medication.||percentage of participants|||Number
703919|NCT00096993|Primary|Progression-free Survival|Progression-free survival was defined as the time from the first day of treatment (Cycle 1, Day 1) to the time of documented disease progression or death, whichever occurred first. Disease progression was assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR) was defined as disappearance of all target lesions; Partial Response (PR) was defined as >=30% decrease in the sum of the longest diameter of target lesions and Overall Response (OR) = CR + PR.|Baseline to the end of the study (up to 1 year)|Efficacy-evaluable population: All randomized participants who received at least 1 dose of study medication.||months||95% Confidence Interval|Median
703920|NCT00085423|Secondary|Time to Progression as Measured by RECIST|Clinical outcome used the National Cancer Institute’s Response Evaluation Criteria in Solid Tumors (RECIST)1.0.|From date of randomization until the first date of documented progression or date of death from any cause, which ever came first, assessed up till 100 months|||years||95% Confidence Interval|Mean
703921|NCT00085423|Secondary|Number of Participants With Lymphocyte Recovery as Measured by Blood Count|Lymphocyte recovery to a greater than 1000 cells/mcL was determined by differential peripheral blood cell counts on sequential days as noted in time frame.|on days 1-15, weekly for 2 weeks, and then every 2-3 months|each patient's differential blood counts were used to determine the time of recovery to the lower limit of normal lymphocytes in the peripheral blood.||participants|||Number
703922|NCT00085423|Primary|Number of partiCIPANTS WITH OBJECTIVE RESPONSE AS MEASURED BY RECIST|Objective response as measured by radiological and physical examination using RECIST criteria.|Response at 12 weeks|Response was determined by physical examination and radiologic testing. Percent of the total number of patients treated was calculated.||participants|||Number
703923|NCT00085436|Secondary|Immunity as Measured by T-cell and Antibody Responses to the Tumor|All patients receiving at least one week of treatment and have at least two time points available for assessment of immune parameters will be include in the evaluation of immune status.|monthly for 5 months||||||
703924|NCT00085436|Primary|Clinical Response as Measured by RECIST Monthly and Then Every 2-3 Months|A total of 18 evaluable patients will be accrued in the first stage. If 4 or fewer responses are observed in the first stage, the trial will be stopped early, otherwise an additional 15 evaluable patients will be accrued for a total of 33 evaluable patients. If 11 or more responses are observed among the 33 patients, the experimental regimen will be considered for further study, otherwise it will be rejected. The trial will not proceed to the second stage unless at least 5 responses are observed in the first stage.|If 4 or fewer responses are observed in the first stage, the trial will be stopped|Clinical response as measured by RECIST monthly and then every 2-3 months||participants|Participants||Number
703925|NCT00085540|Secondary|Response Rate Associated With Depsipeptide Therapy (Phase II)|"RECIST Complete Response (CR): Complete disappearance of all measurable and evaluable disease. No new lesions. No evidence of non-evaluable disease. Patients must be on no steroids.
Partial Response (PR): Greater than or equal to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions.
Stable/No Response: Does not qualify for CR, PR, or progression. The designation of Stable/No Response requires a minimum of 8 weeks duration.
Progression: 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR clear clinical worsening or failure to return for evaluation due to death or deteriorating condition"|Up to 2 years|GBM patients - no responses||participants|||Number
703926|NCT00085540|Primary|6 Months Progression-free Survival (Phase II)|evaluated patients with glioblastoma (GBM (35 patients)|At 6 months|evaluation of patients with GBM histology||percentage of participants|||Number
703927|NCT00085540|Primary|Number of Participants With Dose-limiting Toxicities Due to Romidepsin Graded According to the NCI Common Toxicity Criteria (CTCAE Version 3.0) (Phase I)|"dose limiting toxicity defined as: ANC </=1000 or Platelets <100K; SGOT >/= 3X ULN and T. Bili >/= 1.5 ULN
grade 3 Nausea, vomiting, fatigue and asymptomatic hypocalcemia (treatment may continue after discuss with PI)"|First 4 weeks of treatment|||participants|||Number
703928|NCT00085566|Primary|Overall Objective Response|Response will be evaluated in this study using the new international criteria Response Evaluation Criteria in Solid Tumors (RECIST)|2 years|||participants|||Number
703929|NCT00085631|Primary|Five-Year Overall Survival|Five-year overall survival (OS) time was time from date of randomization until death from any cause. The 5-year OS rate is a percentage, representing the fraction of randomized patients who, after 5 years, are still alive.|5 Years||||||
703930|NCT00085631|Primary|Five-Year Local Recurrence-Free Survival|Five-year local recurrence-free survival (LRFS) time was defined as the time from randomization until local progressive disease or death from any cause. Local recurrence was defined as evidence of disease progression on physical exam or radiologic study, confirmed histologically by tissue biopsy. Progression was defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. The 5-year LRFS rate is a percentage representing the fraction of randomized patients who, after 5 years, do not have local progression or are alive.|5 years||||||
703931|NCT00085631|Primary|Five-year Failure-free Survival|Five-year failure free survival (FFS) time was defined as the time from randomization until relapse/disease progression (local and/or distant) or death from any cause. Progression was defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. The 5-year FFS rate is a percentage representing the fraction of randomized patients who, after 5 years, are disease free or alive.|5 Years||||||
703932|NCT00085631|Primary|Primary Tumor Response Rate at 4-6 Weeks Post Treatment|Primary tumor response rate is the proportion of subjects achieving a best response of complete (CR) or partial (PR) responses, according to the RECIST criteria for change in sum of longest diameters.|3 months from start of therapy||||||
703997|NCT00086190|Secondary|Change in Short Form 36 Health Survey - Mental Health|Short Form 36 Health Survey - Mental Health subscale ranges from 0-100. Higher score indicates a better perceived quality of life.|from the beginning (0 weeks) to end (12 weeks) of the double-blind phase|115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.||Change in SF-36 Mental Health score||Standard Error|Mean
703933|NCT00085644|Secondary|Number of Subjects Achieving the Patient Acceptable Symptoms State Through Week 260 of Adalimumab Exposure|"Completed by subject at each visit. The Patient Acceptable Symptoms State (PASS) was a participant-reported outcome where participants were expected to respond (yes/no) to the following question:
Considering all the different ways your disease is affecting you, if you would stay in this state for the next months, do you consider that your current state is satisfactory?"|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.||participants|||Number
703934|NCT00085644|Secondary|Number of Subjects With Ankylosing Spondylitis Quality of Life Questionaire (ASQoL) MCID Response (MCID <= -1.8 Points) Through Week 260 of Adalimumab Exposure|ASQoL determined participants' quality of life and is comprised of 18 questions (yes or no) to be completed by the participant. Total scores ranged from 0 (good quality of life) to 18 (poor quality of life) related to ability to cope, relationships, mood, sleep, motivation, activities of everyday living, independence, and social life. Decrease in ASQoL score represents improvement. Responders are participants with a minimal clinically important difference (MCID) <= -1.8 points. MCID was determined by a >= 1.8 score decrease during exposure to adalimumab.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.||participants|||Number
703935|NCT00085644|Secondary|Mean Change in the Ankylosing Spondylitis Quality of Life Questionaire (ASQoL) in Subjects Through Week 260 of Adalimumab Exposure|"ASQoL determined participants' quality of life and is comprised of 18 questions (yes or no) to be completed by the participant. Each statement on the ASQoL is given a score of 1 or 0. All item scores were summed to give a total score or index. Total scores ranged from 0 (good quality of life) to 18 (poor quality of life) related to ability to cope, relationships, mood, sleep, motivation, activities of everyday living, independence, and social life. Decrease in ASQoL score represents improvement."|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.||score on a scale||Standard Deviation|Mean
703936|NCT00085644|Secondary|Mean Change in Health Utilities Index-3 (HUI-3) Through Week 260 of Adalimumab Exposure|The HUI-3 is a generic approach to the measurement of health status and assessment of health-related quality of life (HRQL). The HUI-3 classification is comprised of a total score and 8 attributes - Vision, Hearing, Speech, Ambulation, Dexterity, Emotion, Cognition and Pain. The attributes are measures on a scale from the worst score of 0 to best score of 1. The total score scale ranges from dead (= 0) and perfect health (= 1). The total score can have a negative score that is interpreted as worse than dead and the lower limit is –0.36. An increase in the HUI-3 score represents improvement.|Baseline, Weeks 24, 52, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.||score on a scale||Standard Deviation|Mean
703937|NCT00085644|Secondary|Number of Subjects With SF-36 Mental Component Summary (MCS) of Minimal Clinically Important Difference (MCID) Response Through Week 260 of Adalimumab Exposure|"SF-36 is a standardized survey evaluating 8 aspects of functional health and well being; physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, and mental health. The score for a section is an average of the individual question scores, which are scaled 0(no functioning) to 100 (highest level of functioning).
Responders were subjects whose change in MCS fulfilled the Minimal Clinically Important Difference (MCID). The MCID for MCS was determined by a >= 3.0 point increase during exposure to adalimumab."|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.||participants|||Number
703938|NCT00085644|Secondary|Mean Change in the SF-36 Health Survey Index Mental Component Summary (MCS) Through Week 260 of Adalimumab Exposure|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being; physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, and mental health. The score for a section is an average of the individual question scores, which are scaled 0 (no functioning) to 100 (highest level of functioning). The SF-36 Health Survey Index was completed by participants. Components of the SF-36 included the PCS and MCS, respectively. An increase in SF-36 PCS or MCS indicated improvement.|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.||score on a scale||Standard Deviation|Mean
703939|NCT00085644|Secondary|Number of Subjects With SF-36 Physical Component Summary (PCS) of Minimal Clinically Important Difference (MCID) Response Through Week 260 of Adalimumab Exposure|"SF-36 is a standardized survey evaluating 8 aspects of functional health and well being; physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, and mental health. The score for a section is an average of the individual question scores, which are scaled 0(no functioning) to 100 (highest level of functioning).
Responders were subjects whose change in PCS score fulfilled the Minimal Clinically Important Difference (MCID). The MCID for PCS was determined by a >= 3.0 point increase during exposure to adalimumab."|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.||participants|||Number
703940|NCT00085644|Secondary|Mean Change in the SF-36 Health Survey Index Physical Component Summary (PCS) Through Week 260 of Adalimumab Exposure|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being; physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, and mental health. The score for a section is an average of the individual question scores, which are scaled 0 (no functioning) to 100 (highest level of functioning). The SF-36 Health Survey Index was completed by participants. Components of the SF-36 included the PCS and MCS, respectively. An increase in SF-36 PCS or MCS indicated improvement.|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.||score on a scale||Standard Deviation|Mean
703941|NCT00085644|Secondary|Mean Change in Nocturnal Pain in Subjects With Adalimumab Exposure Through Week 260|The subject was to assess his/her nocturnal pain intensity for the past week using a Nocturnal Pain Visual Analog Scale (Nocturnal Pain VAS). The range was 0 to 100 mm with no pain being indicated by 0 and worse possible pain by 100.|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.||mm||Standard Deviation|Mean
703942|NCT00085644|Secondary|Mean Change in Physician's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260|The physician will globally assess the subject's current disease state using a 100-mm VAS scale with 0 being very good and 100 being very bad.|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.||mm||Standard Deviation|Mean
703943|NCT00085644|Secondary|Mean Change From Baseline in the Tender Joint Count for 46 Joints (TJC 46) in Subjects With Adalimumab Exposure Through Week 260|"Assessment of 46 joints for TJC was done by physical examination. Joint tenderness was classified as present (1), absent (0) or injected/replaced (9). The joints assessed were: Sternoclavicular, Acromioclavicular, Shoulder, Elbow, Wrist, Metacarpophalangeal (1-5), Thumb interphalangeal, Proximal interphalangeal (2-5, Hip, Knee, Ankle, and Metatarsophalangeal (1-5)."|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.||score on a scale||Standard Deviation|Mean
703944|NCT00085644|Secondary|Mean Change in Swollen Joint Count for 44 Joints (44 SJC) in Subjects With Adalimumab Exposure Through Week 260|"Change from Baseline in the swollen joint index. An assessment of 44 joints for SJC done by physical examination. Joint swelling was classified as present (1), absent (0) or injected/replaced (9). The joints assessed were: Sternoclavicular, Acromioclavicular, Shoulder, Elbow, Wrist, Metacarpophalangeal (1-5), Thumb interphalangeal, Proximal interphalangeal (2-5, Knee, Ankle, and Metatarsophalangeal (1-5)."|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.||score on a scale||Standard Deviation|Mean
703945|NCT00085644|Secondary|Mean Change in the Bath Ankylosing Spondylitis Global Index (BAS-G) in Subjects With Adalimumab Exposure Through Week 260|BAS-G was measured by two VAS scores (0 to 100 mm) to reflect the effect of Ankylosing Spondylitis on subject's well-being over the past week and over the last 6 months, respectively. The average of these two scores was reported.|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.||score on a scale||Standard Deviation|Mean
703946|NCT00085644|Secondary|Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Subjects With Adalimumab Exposure Through Week 260|MASES is measured by scoring of entheses of 0 (no tenderness) to 3 (severe tenderness) at 13 sites on the body. The score was derived as the sum of the 13 scores divided by 3 and the total range is 0 to 13 (minimum to maximum number and severity of enthesitis).|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.||score on a scale||Standard Deviation|Mean
703947|NCT00085644|Secondary|Mean Change in Chest Expansion (CE) in Subjects With Adalimumab Exposure Through Week 260 [|"The patient is in a sitting position on the examination table with the hands on the hips. A pen mark is made at the xiphisternum and a tape measure placed around the circumference of the patient's chest at this level. The patient is asked to take a deep breath and to exhale as completely as possible while looking directly ahead. The measurement (in cm) is noted. The patient is asked to inhale as deeply as possible and the measurement (in cm) is noted. The difference in the 2 measurement points (in cm) constitutes the value for CE.
An increase in chest expansion represents improvement"|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.||cm||Standard Deviation|Mean
708922|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 6|Estimated forced expiratory volume in one second (FEV1) before bronchodilator at month 6|Month 6|||L||Standard Error|Mean
703948|NCT00085644|Secondary|Mean Change in the Bath Ankylosing Spondylitis Metrology Index (BASMI) in Subjects With Adalimumab Exposure Through Week 260|BASMI measures the range of motion based on five clinical measurements: 1) cervical rotation, 2) tragus to wall distance, 3) lumbar side flexion, 4) lumbar flexion (modified Schober's) and 5) intermalleolar distance. BASMI 0 = indicates mild disease involvement, 1 = moderate disease, and 2 = severe disease involvement. The results for cervical rotation and lumbar side flexion are the means of the left and right measurements. Scoring range 0-10. The higher the BASMI score, the more severe was the subject's limitation of movement due to their AS.|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.||score on a scale||Standard Deviation|Mean
703949|NCT00085644|Secondary|Number of Subjects With a Disease Controlling Clinical Response From Adalimumab as Measured by ASAS Partial Remission Response in Subjects With Adalimumab Exposure Through Week 260|ASAS partial remission was calculated as follows: A value below 20 on a 0 - 100 point scale in each of the four domains of the ASAS (Patient's Global Assessment of Disease Activity, Pain, Function, and Inflammation). Partial remission is also regarded as a low disease activity state.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.||participants|||Number
703950|NCT00085644|Secondary|Number of Subjects With a Disease Controlling Clinical Response From Adalimumab as Measured in Assessments of Ankylosing Spondylitis Ankylosing Spondylitis (ASAS) 5/6 in Subjects With Adalimumab Exposure Through Week 260|"The change in ASAS 5/6 was evaluated for the effect of adalimumab on structural damage.
ASAS 5/6 criteria is the 20% improvement in 5 out of 6 domains (physical function [BASFI], Total Back Pain, Patient's Global Assessment of Disease Activity, Inflammation [mean of Questions 5 and 6 of the BASDAI], spinal mobility [BASMI], and acute phase reactants [CRP])."|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.||participants|||Number
703951|NCT00085644|Secondary|Number of Subjects With a Disease Controlling Clinical Response From Adalimumab as Measured in Assessments of Ankylosing Spondylitis (ASAS) 40 - Through Week 260 of Adalimumab Exposure|ASAS 40 responders - improvement of >=40% and absolute improvement of >=20 units from Baseline in a visual analog scale (VAS) for >=3 of 4 domains; Patient's Global Assessment of disease activity VAS (0 [none] to 100 [severe]); Total Back Pain VAS (0 [no pain] to 100 [severe]); BASFI VAS (0 [easy] to 100[impossible]); and Inflammation VAS (1 [none] to 10 [very severe]); and absence of any deterioration in the potential remaining domain. Applied to each scale and not to an overall global scale.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.||participants|||Number
703952|NCT00085644|Secondary|Mean Change in C-Reactive Protein (CRP) (mg/dL) in Subjects With Adalimumab Exposure Through Week 260|Evaluation of the mean changes in CRP in subjects with adalimumab exposure from Baseline through 5 years. The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation via the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation. A decrease in CRP indicates improvement.|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.||mg/dL||Standard Deviation|Mean
703953|NCT00085644|Secondary|Mean Change in BASDAI in Subjects With Adalimumab Exposure Through Week 260|The BASDAI is a questionnaire with 6 questions that subject completes by marking answers on a 10-cm Visual Analog Scale (VAS) during the last week with responses that range from 0 (none) to 10 (very severe) and measures severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 (none) to 10 (severe). A decrease in BASDAI represents improvement. BASDAI Scoring: 1) Measure each item of the BASDAI in centimeters (out of a total of 10) 2) BASDAI Score = 0.2 (Item 1 + Item 2 + Item 3 + Item 4 + Item 5/2 + Item 6/2).|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.||cm||Standard Deviation|Mean
703954|NCT00085644|Secondary|Number of Subjects With a Reduction of Signs and Symptoms as Measured in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 70 Through Week 260 of Adalimumab Exposure|"The BASDAI is a questionnaire with 6 questions that subject completes by marking answers on a 10-cm Visual Analog Scale (VAS) during the last week with responses that range from 0 (none) to 10 (very severe) and measures severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 to 10. Improvement in BASDAI by 70% was assessed. BASDAI Scoring:
Measure each item of the BASDAI in centimeters (out of a total of 10) BASDAI Score = 0.2 (Item 1 + Item 2 + Item 3 + Item 4 + Item 5/2 + Item 6/2)."|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.||participants|||Number
704371|NCT00099021|Secondary|Interleukin 6, 8 and Vascular Endothelial Growth Factors Elaboration in the Oral Cavity and Serum|Quantitative studies of serum and saliva components for a pre and post treatment possible biomarker.|Pre (Day 0) and Post (Week 12) Treatment||||||
703955|NCT00085644|Secondary|Number of Subjects With a Reduction of Signs and Symptoms as Measured in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Through Week 260 of Adalimumab Exposure|"The BASDAI is a questionnaire with 6 questions that subject completes by marking answers on a 10-cm Visual Analog Scale (VAS) during the last week with responses that range from 0 (none) to 10 (very severe) and measures severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 to 10. Improvement in BASDAI by 50% was assessed. BASDAI Scoring:
Measure each item of the BASDAI in centimeters (out of a total of 10) BASDAI Score = 0.2 (Item 1 + Item 2 + Item 3 + Item 4 + Item 5/2 + Item 6/2)."|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.||participants|||Number
703956|NCT00085644|Secondary|Number of Subjects With a Reduction of Signs and Symptoms as Measured in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 20 Through Week 260 of Adalimumab Exposure|"The BASDAI is a questionnaire with 6 questions that subject completes by marking answers on a 10-cm Visual Analog Scale (VAS) during the last week with responses that range from 0 (none) to 10 (very severe) and measures severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 (none) to 10 (very severe). Improvement in BASDAI by 20% was assessed. BASDAI Scoring:
Measure each item of the BASDAI in centimeters (out of a total of 10) BASDAI Score = 0.2 (Item 1 + Item 2 + Item 3 + Item 4 + Item 5/2 + Item 6/2)."|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.||participants|||Number
703957|NCT00085644|Secondary|Number of Subjects With a Reduction of Signs and Symptoms as Measured in Inflammation (Individual Component of ASAS 20) (Mean of BASDAI Questions 5 and 6) Through Week 260 of Adalimumab Exposure|"The inflammation score is the mean of the two morning stiffness-related BASDAI visual analog scale (VAS) scores (items 5 and 6 of the BASDAI): overall level of morning stiffness (0 [none] to 10 [very severe]) and duration of morning stiffness (0 [0 hours] to 10 [2 or more hours]). A decrease in inflammation represents improvement.
A responder is a participant who demonstrates an absolute improvement of at least 10 units and a percentage improvement of at least 20% from Baseline in inflammation (mean of the BASDAI questions 5 and 6 on scale of 0 [none] to 10 [very severe]."|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.||participants|||Number
703958|NCT00085644|Secondary|Mean Change in Inflammation (Mean of BASDAI Questions 5 and 6) in Subjects With Adalimumab Exposure Through Week 260|The inflammation score is the mean of the two morning stiffness-related BASDAI visual analog scale (VAS) scores (items 5 and 6 of the BASDAI): overall level of morning stiffness (0 [none] to 10 [very severe]) and duration of morning stiffness (0 [0 hours] to 10 [2 or more hours]). A decrease in inflammation represents improvement.|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.||cm||Standard Deviation|Mean
703959|NCT00085644|Secondary|Number of Subjects With a Reduction of Signs and Symptoms as Measured in Total Back Pain (an Individual Component of ASAS 20) Through Week 260 of Adalimumab Exposure|Participants assessed disease activity in the past week using a total spine VAS on a scale 0 (no pain) to 100 (severe pain). A responder is a participant who demonstrates an absolute improvement of at least 10 units and a percentage improvement of at least 20% from Baseline.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.||participants|||Number
703960|NCT00085644|Secondary|Mean Change in Total Back Pain Visual Analog Scale (VAS) in Subjects With Adalimumab Exposure Through Week 260|Evaluation of the effect of 40 mg every other week (eow) adalimumab on Total Back Pain VAS. The subject was to assess his/her disease activity in the past week using a total spine VAS on a scale 0 (no pain) to 100 (severe pain).|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.||mm||Standard Deviation|Mean
703961|NCT00085644|Secondary|Number of Subjects With a Reduction of Signs and Symptoms as Measured in BASFI (an Individual Component of ASAS 20) Through Week 260 of Adalimumab Exposure|BASFI consisted of 10 Visual Analog Scale (VAS) questions with a response ranging from 0 (easy) to 100 (impossible). The BASFI score was derived based on the average of questions 1 through 10. A responder is a subject who demonstrates an absolute improvement of at least 10 units and a percentage improvement of at least 20% from Baseline.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.||participants|||Number
703998|NCT00086190|Secondary|Change in Short Form 36 Health Survey - Role-Emotional|Short Form 36 Health Survey - Emotional subscale ranges from 0-100. Higher score indicates a better perceived quality of life.|from the beginning (0 weeks) to end (12 weeks) of the double-blind phase|115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.||Change in SF-36 Role score||Standard Error|Mean
703962|NCT00085644|Secondary|Mean Change in the Bath Ankylosing Spondylitis Functional Index (BASFI) in Subjects With Adalimumab Exposure Through Week 260|BASFI consist of a set of 10 questions designed to determine the degree of functional limitation in subjects with AS. The BASFI score was derived based on the average of questions 1 through 10. The first 8 questions considered activities related to functional anatomy and the final 2 questions assessed the subject's ability to cope with everyday life over the last week. A 100-mm visual analog scale (VAS) was used to answer the questions and the mean of the ten scales gave the BASFI score a value between 0 (easy) and 100 (impossible).|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.||mm||Standard Deviation|Mean
703963|NCT00085644|Secondary|Number of Subjects With a Reduction of Signs and Symptoms as Measured in Patient's Global Assessment of Disease Activity (an Individual Component of ASAS 20) Through Week 260 of Adalimumab Exposure|The patient assesses his/her disease activity for the past week using a Patient Global Assessment of Disease on visual analog scale (VAS) with 0 being none and 100 being severe.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.||participants|||Number
703964|NCT00085644|Secondary|Mean Change in Patient's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260|Evaluation of the effect of adalimumab 40 mg every other week (eow) on patient's global assessment of disease activity. The patient was to assess his/her disease activity in the past week using a visual analog scale (VAS) on a scale of 0 to 100 mm with no activity being indicated by 0 and severe activity by 100.|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.||mm||Standard Deviation|Mean
703965|NCT00085644|Secondary|Number of Subjects With a Reduction of Signs and Symptoms as Measured in Assessments of Ankylosing Spondylitis (ASAS) 70 - Through Week 260 of Adalimumab Exposure|ASAS 70 responders - improvement of >=70% and absolute improvement of >=30 units from Baseline in a visual analog scale (VAS) for >=3 of 4 domains: Patient's Global Assessment of disease activity VAS (0 [none] to 100 [severe]), Total Back Pain VAS; (0 [no pain] - 100 [severe]), BASFI VAS (0 [easy] to 100[impossible]); and Inflammation VAS (1 [none] to 10 [very severe]); and absence of deterioration in the potential remaining domain, defined as defined as a worsening of >= 20% and a net worsening of >= 10 units. Applied to each scale and not to an overall global scale.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.||participants|||Number
703966|NCT00085644|Secondary|Number of Subjects With a Reduction of Signs and Symptoms as Measured in Assessments of Ankylosing Spondylitis (ASAS) 50 - Through Week 260 of Adalimumab Exposure|ASAS 50 responders - improvement of >=50% and absolute improvement of >=20 units from Baseline in a visual analog scale (VAS) for >=3 of 4 domains: Patient's Global Assessment of disease activity VAS (0 [none] to 100 [severe]); Total Back Pain VAS (0 [no pain] to 100 [severe]); BASFI VAS (0 [easy] to 100[impossible]); and Inflammation VAS (1 [none] to 10 [very severe]); and absence of deterioration in the potential remaining domain, defined as a worsening of >=20% and a net worsening of >=10 units. Applied to each scale and not to an overall global scale.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.||participants|||Number
703967|NCT00085644|Secondary|Number of Subjects With a Reduction of Signs and Symptoms as Measured in Assessments of Ankylosing Spondylitis (ASAS) 20 - Through Week 260 of Adalimumab Exposure|ASAS 20 responders - improvement of >=20% and absolute improvement of >=10 units from Baseline in a visual analog scale (VAS) for >=3 of 4 domains; Patient's Global Assessment of disease activity VAS; (0[none]-100 [severe]), Total Back Pain VAS; (0 [no pain]-100 [severe]), BASFI VAS (0 [easy ]-100[impossible]); and Inflammation VAS (0 [none] to 10 [very severe]) and absence of deterioration in the potential remaining domain, defined as a worsening of >=20% and a net worsening of >=10 units. Applied to each scale and not to an overall global scale.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.||participants|||Number
703968|NCT00085644|Primary|Mean Change in the Modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) Compared Against a Historical Control Group (Outcomes in Ankylosing Spondylitis International Study [OASIS]) Using the ANCOVA Model Adjusting for Baseline mSASSS Score|Radiographic progression was based on change in mSASSS scoring (comparison of the means) from double-blind Baseline visit to Week 104. The mSASSS is the sum of the lumbar and cervical spine score ( 0 [no change] to 72 [progression]), derived from scoring the anterior site of the lumbar spine (T12 to S1) and the cervical spine (C2 to T1) as either 0 (normal), 1 (erosion, sclerosis, or squaring), 2 (syndesmophyte), 3 (bridging syndesmophyte), or N (vertebral body not evaluable). Data from NCT00195819 was compared with data from AS patients in OASIS.|Week 104|The OASIS cohort is a historical control group of Dutch, French, and Belgian patients with AS who have been followed up since 1996. These patients participated in a follow-up study on the natural course of AS with conventional (non-biologic) treatment.||score on a scale||Standard Error|Mean
704372|NCT00099021|Secondary|Quantitative Oil Red O, AP2 (FABP4) and FABP5 Staining|Immune histochemistry / tissue staining for a possible biomarker.|Pre (Day 0) and Post (Week 12) Treatment||||||
703969|NCT00085644|Primary|Number of Responders With a Reduction of Signs and Symptoms of Ankylosing Spondylitis (AS) as Measured With ASAS International Working Group Response Criteria (ASAS 20).|ASAS 20 responders - improvement of >=20% and absolute improvement of >=10 units from Baseline in a visual analog scale (VAS) for >=3 of 4 domains; Patient's Global Assessment of disease activity VAS (0 [none]-100 [severe]), Total Back Pain VAS (0 [no pain]-100 [severe]), BASFI VAS (0 [easy]-100[impossible]); and Inflammation VAS (0 [none]-10 [very severe]) and absence of deterioration in the potential remaining domain, defined as a worsening of >=20% and a net worsening of >=10 units. Applied to each scale and not to an overall global scale.|Week 12|||Participants (responders, nonresponders)|||Number
703970|NCT00085709|Secondary|Toxicity|Number of patients with Grade 3-5 adverse events that are related to study drug by given type of adverse event|For induction, daily for the first 10 days, then twice weekly until consolidation treatment. Weekly during consolidation treatment. Weekly if randomized to post-consolidation G.O.|Eligible patients who started therapy||Participants with a given type of AE|||Number
703971|NCT00085709|Primary|Complete Remission||After induction therapy was completed (1 or 2 months)|Eligible patients who did not withdraw consent||participants|||Number
703972|NCT00085709|Primary|2-year Disease-free Survival (DFS)|Measured from data of randomization to post-consolidation therapy until relapse from complete response or death from any cause, with observations censored at the date of last contact for patients last known to be alive without report of relapse.|After completing any treatment, every 6 months for 2 years, than annually for years 3-5|Eligible patients who completed induction and consolidation therapy||Percentage of population||95% Confidence Interval|Number
703973|NCT00085735|Secondary|Compliance Rates for All Eligible and Evaluable Patients Enrolled|A patient will be considered to be compliant if the patient/parent participated in the PedsQLTM v4 and the ABAS assessment. The patient should have a PedsQL total score which measures quality of life and a general adaptive composite (GAC) score which measures adaptive functioning. Compliance rates will be assessed at each of the 3 neurocognitive/quality of life assessment time points. All eligible and evaluable patients enrolled on ACNS0331 will be used. Patients removed from treatment prior to the time of neuropsychological assessment (for reasons such as disease progression, death, withdrawal of consent, etc.) will not be included in the denominator to assess the compliance rate.|Up to 6 years post-diagnosis||||||
703974|NCT00085735|Secondary|Time to Recurrence, Progression or Death Due to Cancer / Progression-free Survival (PFS) by Molecular Subgroup Based on Methylation Arrays|Time from study entry to disease progression, relapse or death due to cancer or to last follow-up. Deaths from causes that are clearly not associated with tumor recurrence or progression and second malignancies will be censored. Three-year PFS rates will be reported by methylation subgroup. Randomized eligible and evaluable patients (patients without disease dissemination or excess residual disease by central review and patients without anaplastic histology) will be included.|Assessed at 3 years||||||
703975|NCT00085735|Secondary|Time to Death From Any Cause / Overall Survival (OS) by Molecular Subgroup Based on Methylation Arrays|Three-year survival rates will be reported by methylation subgroup. Randomized eligible and evaluable patients (patients without disease dissemination or excess residual disease by central review and patients without anaplastic histology) will be included.|Assessed at 3 years||||||
703976|NCT00085735|Secondary|Incidence of Endocrine Dysfunction as Measured by Growth Hormone Stimulation Test at the Completion of Therapy.|Incidence rates of abnormal growth hormone stimulation tests at the after completion of therapy assessment will be reported separately for eligible and evaluable IFRT and PFRT patients.|After completion of therapy, an average of 2 years||||||
703977|NCT00085735|Secondary|Incidence of Grade 3+ Hearing Loss at 1-year Post Treatment as Assessed by CTCAE Version 4|Proportions of pts with grade 3+ hearing impairment as assessed by CTCAE v4 at 1-year post treatment were calculated.|1 year after end of treatment|Eligible & evaluable pts were included. Pts with anaplastic histology or disseminated/excess residual disease were not evaluable(NE). 26/23 IFRT/PFRT pts were NE, leaving 227 vs 237 eligible/evaluable pts. However some pts (28/22) weren't followed for at least 1-yr post-off tx (e.g., withdrew consent for FU or died), leaving 199 IFRT/215 PFRT pts.||Percentage of pts with g3+ hearing loss|||Number
703978|NCT00085735|Secondary|Post-treatment Neurocognitive Function as Measured by the Estimated Full-scale IQ (FSIQ) and Also the Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF)|Average scores for FSIQ and MI will be reported at each of the 3 neurocognitive assessment time points by LDCSI vs. SDCSI groups. All eligible and evaluable patients 3-7 years of age will be used.|Up to 6 years post-diagnosis||||||
703979|NCT00085735|Secondary|Post-treatment Grade 3+ Hearing Loss as Measured by CTCAE v4|Proportions of patients with grade 3+ hearing loss after the completion of therapy will be calculated and reported separately for LDCSI vs. SDCSI patients. Eligible and evaluable patients 3-7 years of age will be used.|Up to 1 year after the end of treatment|Only eligible & evaluable pts 3-7 years of age are included since only younger pts were randomized to either LD or SD CSI. 11 and 8 LDCSI and SDCSI pts respectively were not evaluable due to anaplastic disease or excess residual/disseminated disease, leaving 116 vs 110 patients for this analysis.||Percentage of pts with g3+ hearing loss|||Number
703980|NCT00085735|Secondary|Post-treatment Endocrine Function (Growth Hormone (GH) and Thyroid Stimulating Hormone (TSH) as Measured by Laboratory Assessment)|Growth hormone stimulation tests were performed and noted as normal or abnormal at baseline and after completion of therapy/follow-up. Proportions of patients with abnormal results after completion of therapy will be calculated and reported separately for LDCSI vs. SDCSI patients. Mean post-treatment TSH levels will be reported by CSI group. Eligible and evaluable patients 3-7 years of age will be used.|Up to 3 years||||||
703981|NCT00085735|Secondary|Non-posterior Fossa (NPF) Failure Rate|NPF failure was defined as tumor recurrence within the neuroaxis but outside the radiation therapy clinical target volume (CTV). The cumulative incidence (CI) of NPF failure was estimated; 3-year estimates were reported with 95% confidence intervals. Patients with other failure types (e.g., LPF failure) and with other events prior to NPF failure (e.g., death, second malignancy) were considered as having competing events.|3 years|Eligible and evaluable patients 3-21 yrs of age are included. Patients with anaplastic histology or disseminated/excess residual disease were not evaluable (NE). Arms I/III/V [IFRT] are combined & arms II/IV/VI [PFRT] are combined. 26 & 23 IFRT & PFRT pts were NE and were excluded, leaving 227 and 237 eligible and evaluable pts.||Percentage of 3 yr cumulative incidence||95% Confidence Interval|Number
703982|NCT00085735|Secondary|Non-local Posterior Fossa (NLPF) Failure Rate|NLPF failure was defined as tumor recurrence/progression outside the radiation therapy clinical target volume boost (CTV-boost) but within the posterior fossa CTV (CTV-PF). The cumulative incidence (CI) of NLPF failure was estimated; 3-year estimates were reported with 95% confidence intervals. Patients with other failure types (e.g., NPF, LPF) and with other events prior to NLPF failure (e.g., death, second malignancy) were considered as having competing events.|3 years|Eligible and evaluable patients 3-21 yrs of age are included. Patients with anaplastic histology or disseminated/excess residual disease were not evaluable (NE). Arms I/III/V [IFRT] are combined & arms II/IV/VI [PFRT] are combined. 26 & 23 IFRT & PFRT pts were NE and were excluded, leaving 227 and 237 eligible and evaluable pts.||Percentage of 3 yr cumulative incidence||95% Confidence Interval|Number
703983|NCT00085735|Secondary|Local Posterior Fossa (LPF) Failure Rate|LPF failure was defined as tumor recurrence/progression within the tumor bed. The cumulative incidence (CI) of LPF failure was estimated; 3-year estimates were reported with 95% confidence intervals. Patients with other failure types (e.g., NPF) and with other events prior to LPF failure (e.g., death, second malignancy) were considered as having competing events.|3 years|Eligible and evaluable patients 3-21 yrs of age are included. Patients with anaplastic histology or disseminated/excess residual disease were not evaluable (NE). Arms I/III/V [IFRT] are combined & arms II/IV/VI [PFRT] are combined. 26 & 23 IFRT & PFRT pts were NE and were excluded, leaving 227 and 237 eligible and evaluable pts.||percentage 3 yr cumulative incidence||95% Confidence Interval|Number
703984|NCT00085735|Secondary|Overall Survival (OS)|OS was defined as the time interval from date of study entry to date of death from any cause or to the date of last follow-up for survivors. OS was estimated using the method of Kaplan and Meier. 3-year estimates are reported with 95% CI's. For purposes of this analysis, arms I, III and V [IFRT] are combined and compared to arms II, IV and VI [PFRT].|3 years|Per protocol only eligible & evaluable pts were included.Pts with anaplastic histology or disseminated/excess residual disease were not evaluable (NE). 26/23 IFRT/PFRT pts were NE, leaving 227 vs 237 for this comparison. The LD/SD CSI comparison was done only in pts 3-7 yrs of age. 11/8 LD/SDCSI pts were NE, leaving 116 vs 110 for this comparison.||Probability of 3 yr OS rate||95% Confidence Interval|Number
703985|NCT00085735|Primary|Event-free Survival (EFS)|EFS was defined as the time interval from date of study entry to date of disease progression, disease recurrence, second malignant neoplasm or death from any cause, whichever occurs first, or to the date of last follow-up for patients without events. EFS was estimated using the method of Kaplan and Meier. 3-year estimates are reported with 95% CI's.|3 years|Per protocol only eligible & evaluable pts are included. Pts with anaplastic histology or disseminated/excess residual disease were not evaluable (NE). 26/23 IFRT/PFRT pts were NE, leaving 227 vs 237 for this comparison. The LD/SD CSI comparison was done only in pts 3-7 yrs of age. 11/8 LD/SDCSI pts were NE, leaving 116 vs 110 for this comparison.||probability of 3 year EFS||95% Confidence Interval|Number
703986|NCT00085839|Secondary|Best Tumor Response|Change in size of tumor: Complete Response (CR) = no measurable tumor; Partial Response (PR) = 30% decrease in size of measurable tumor; Stable Disease (SD) = measurable tumor size has not changed; Progressive Disease (PD) = measurable tumor 20% larger than at baseline.|While receiving study treatment (maximum 60 weeks)|All patients who received at least 1 dose of study drug and who had both a baseline and at least one on-treatment tumor assessment.||participants|||Number
703987|NCT00085839|Secondary|Overall Survival|Median number of months from first study treatment until time of death|From first study treatment until time of death (maximum 26.8 months)|All patients who received at least 1 dose of study drug and who had both a baseline and at least one on-treatment tumor assessment.||months||95% Confidence Interval|Median
703988|NCT00085839|Primary|Progression-free Survival|Median time until disease progression. Disease progression defined as radiological and/or symptomatic disease progression or death in absence of progression.|Until time of disease progression (maximum 5 months)|All patients who received at least 1 dose of study drug and who had both a baseline and at least one on-treatment tumor assessment.||months||95% Confidence Interval|Median
703989|NCT00085917|Secondary|Number of Participants With Adverse Events|"Adverse Events
- Anemia, Neutropenia and Psychiatric adverse events"|48 weeks|||participants|||Number
703990|NCT00085917|Secondary|Number of Participants With Normalization of Liver Enzymes|normalization of liver enzymes :Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) Alanine aminotransferase (ALT): Normal 6 - 41 U/L Aspartate aminotransferase (AST) : Normal 9 - 34 U/L|week 24, week 48, week 72|||participants|||Number
703991|NCT00085917|Primary|Number of Participants With Sustained Virologic Response (SVR)|SVR [ Sustained virological response] SVR was defined as HCV RNA levels below the limit of detection 24 weeks after the end of treatment.|72 weeks|||participants|||Number
703992|NCT00086047|Secondary|Depressive Symptoms||9 weeks and 6 months||||||
703993|NCT00086047|Secondary|Pain Intensity||9 weeks and 6 months||||||
703994|NCT00086047|Primary|Change in FDI (Functional Disability Inventory) Scores at End of Study|Functional disability score is measured by the Functional Disability Inventory (FDI)which assesses ability to engage in usual physical, social and recreational activities. Scores range from 0=no disability to 60 = extreme disability and and are interpreted as No/Mild disability (0-12); Moderate Disability (13-29) and Severe Disability (30-60)|Baseline and 6 months (end of study)|Intent to treat analysis||units on a 0-60 scale||95% Confidence Interval|Mean
703995|NCT00086138|Secondary|Remission According to Cornell Scale for Depression in Dementia Scale|The Cornell Scale for Depression in Dementia (CSDD), a 19-item scale measuring the severity of depression in dementia, utilizing input from both the caregiver and the participant. CSDD scores were imputed for 2 participants for week 2, 4 participants for week 4, 7 participants for week 8, and 12 participants for week 12.|Measured at Weeks 12|||percentage of participants|||Number
703996|NCT00086138|Primary|Modfied Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (mADCS-CGIC)|At each study visit, based on patient examination and caregiver interview, clinicians rated overall impression of clinical change from baseline using the modified Alzheimer’s Disease Cooperative Study Clinical Global Impression of Change index (mADCS-CGIC), which in addition to the original scale incorporates a global rating of mood and associated symptoms of depression. The mADCS-CGIC uses a seven-point Likert scale, with scores ranging from 1 (“much better”) to 7 (“much worse”), with a score of 4 being “no change”.|Measured at Week 12|||participants|||Number
704373|NCT00099021|Secondary|Involucrin and Transglutaminase Staining|Immune histochemistry / tissue staining for a possible biomarker.|Pre (Day 0) and Post (Week 12) Treatment||||||
703999|NCT00086190|Secondary|Change in Short Form 36 Health Survey - Vitality|Short Form 36 Health Survey - Vitality subscale ranges from 0-100. Higher score indicates a better perceived quality of life.|from the beginning (0 weeks) to end (12 weeks) of the double-blind phase|115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.||Change in SF-36 vitality score||Standard Error|Mean
704000|NCT00086190|Secondary|Change in Short Form 36 Health Survey - Mental Component Summary|Short Form 36 Health Survey. Range 0-100. Higher score indicates a better perceived quality of life.|from the beginning (0 weeks) to end (12 weeks) of the double-blind phase|115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.||Change in SF-36 mental score||Standard Error|Mean
704001|NCT00086190|Secondary|Change in Parkinson's Disease Questionnaire (PDQ) - 39 - Emotional Well-Being|Parkinson's Disease Questionnaire (PDQ-39) - Emotional Well-Being maximum score 24, minimum score of 0.Lower score indicates a better perceived health status.|from the beginning (0 weeks) to end (12 weeks) of the double-blind phase|115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.||Change in PDQ-39 Emotional score||Standard Error|Mean
704002|NCT00086190|Secondary|Change in Parkinson's Disease Questionnaire (PDQ) - 39 - Overall|Parkinson's Disease Questionnaire (PDQ-39) Total. Range 0-100. Lower score indicates a better perceived health status.|from the beginning (0 weeks) to end (12 weeks) of the double-blind phase|115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.||Change in PDQ-39 score||Standard Error|Mean
704003|NCT00086190|Secondary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Bulbar|Unified Parkinson's Disease Rating Scale - Bulbar maximum score 24, minimum score of 0. Higher score indicates more severe Parkinson's disease symptoms.|from the beginning (0 weeks) to end (12 weeks) of the double-blind phase|115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.||Change in UPDRS-Bulbar score||Standard Error|Mean
704004|NCT00086190|Secondary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Tremor|Unified Parkinson's Disease Rating Scale - Tremor subscale ranges from 0-23. Higher score indicates more severe Parkinson's disease symptoms.|from the beginning (0 weeks) to end (12 weeks) of the double-blind phase|115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.||Change in UPDRS-tremor score||Standard Error|Mean
704005|NCT00086190|Secondary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Motor|Unified Parkinson's Disease Rating Scale - Motor has a maximum score of 72, minimum score of 0. Higher score indicates more severe Parkinson's disease symptoms.|from the beginning (0 weeks) to end (12 weeks) of the double-blind phase|115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.||Change in UPDRS-motor score||Standard Error|Mean
704006|NCT00086190|Secondary|Change in Pittsburgh Sleep Quality Index (PSQI)|Pittsburgh Sleep Quality Index scores range from 0-21, with higher scores indicating severe sleep difficulties.|from the beginning (0 weeks) to end (12 weeks) of the double-blind phase|115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.||Change in PQSI score||Standard Error|Mean
704007|NCT00086190|Secondary|Change in Snaith Clinical Anxiety Scale (CAS)|Snaith Clinical Anxiety Scale. Range 0-21. Higher scores indicate increased anxiety. Score greater than 8 indicates clinical anxiety.|from the beginning (0 weeks) to end (12 weeks) of the double-blind phase|115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.||Change in CAS score||Standard Error|Mean
704008|NCT00086190|Secondary|Change in Unified Parkinson’s Disease Rating Scale (UPDRS)|Unified Parkinson's Disease Rating Scale. Higher score indicates more severe Parkinson's disease symptoms. Total maximum = 176. Mental maximum = 52, Activities of Daily Living maximum = 52, Motor maximum = 72. Minimum = 0.|from the beginning (0 weeks) to end (12 weeks) of the double-blind phase|115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.||Change in UPDRS score||Standard Error|Mean
704009|NCT00086190|Secondary|Change in Brief Psychiatric Rating Scale (BPRS)|Brief Psychiatric Rating Scale. Maximum score 126. Higher score indicates greater psychiatric difficulties.|from the beginning (0 weeks) to end (12 weeks) of the double-blind phase|115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.||Change in BPRS score||Standard Error|Mean
704010|NCT00086190|Secondary|Change in Geriatric Depression Rating Scale (GDS)|Geriatric Depression Scale ranges from 0-30. Higher score indicates more severe depression. 0-9 normal, 10-19 mild depression, 20-30 severe depression.|from the beginning (0 weeks) to end (12 weeks) of the double-blind phase|115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.||Change in GDS score||Standard Error|Mean
704011|NCT00086190|Secondary|Change in Beck Depression Inventory II (BDI-II)|Beck Depression Inventory II ranges from 0-63. Higher score indicates more severe depression. 0-13 minimal depression, 14-19 mild depression, 20-28 moderate depression, 29-63 severe depression.|from the beginning (0 weeks) to end (12 weeks) of the double-blind phase|115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.||Change in BDI-II score||Standard Error|Mean
704012|NCT00086190|Secondary|Change in Montgomery-Asberg Depression Rating Scale (MADRS)|Montgomery-Asberg Depression Rating Scale ranges from 0-60. Higher score indicates more severe depression. 0-6 normal, 7-19 mild depression, 20-34 moderate depression, greater than 34 severe depression.|from the beginning (0 weeks) to end (12 weeks) of the double-blind phase|115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.||Change in MADRS score||Standard Error|Mean
704013|NCT00086190|Primary|Change in Hamilton Depression Rating Scale (HAM-D) Scores|Change in Hamilton Rating Scale for Depression over 12 weeks. Hamilton Depression Rating Scale ranges from 0-50. Higher scores represent more significant depression. Mild depression ranges from 8-13, moderate depression from 14-18, severe 19-22 and very severe any score over 23.|from the beginning (0 weeks) to end (12 weeks) of the double-blind phase|115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.||Change in HAM-D score||Standard Deviation|Mean
704014|NCT00086281|Primary|The Primary Efficacy Variable Was the Mean Apnea-Hypopnea Index (AHI).|The AHI was defined as the incidence(events per hour) of apnea and hypopnea events associated with sleep, determined from the overnight polysomnogram (PSG). An apnea event is characterized by a cessation in airflow lasting >= 10 seconds, accompanied by oxygen desaturation of >3% or arousal. An Hyponea event is characterized by a transient reduction in breathing lasting >= 10 seconds, with clear decrease (>50%) from baseline in the amplitude of breathing or a decrease <50% in the amplitude of breathing accompanied by oxygen desaturation of >3% or arousal.|One night of PSG during one night of treatment each per arm.|||Apnea + Hypopnea episodes per hour||Standard Deviation|Mean
704015|NCT00086307|Primary|Montgomery Asberg Depression Rating Scale (MADRS)|The Montgomery Asberg Depression Rating Scale (MADRS) is a 10 item scale for assessing the severity of depression. Items are rated on a scale of 0 to 6, so the maximum score is 60 and the minimum is 0, where 60 is the most severe depression. Scores of 18 or greater are generally considered to indicate a moderate level of depression.|Weekly|All patients with at least one post-baseline measurement were included in the analysis.||Score on a scale||Standard Error|Least Squares Mean
704016|NCT00086346|Primary|Patient and Graft Survival|Endpoint was a composite assessment of patient and graft survival. Patients categorized as graft survival or graft loss. Graft loss defined as pure graft loss (requiring retransplant) or death (with a functioning graft), if the event occurred in the first 12 months after randomization. Patients with missing graft data were counted as graft losses.|12 months|Intent to treat analysis population with stratification by antimetabolite therapy and hepatitis C status.||patients|||Number
704017|NCT00086346|Secondary|Mean Serum Creatinine|Observed mean values for serum creatinine.|12 months|On-therapy population; consisted of patients who were still receiving study medication at the defined endpoint.||µmol/L||Standard Deviation|Mean
704018|NCT00086346|Secondary|Number of Patients With a Biopsy Confirmed Acute Rejection|Overall event rate is determined as yes or no.|12 months|The analysis population is the intent to treat. Any patient whose clinical rejection data was incomplete was designated as an acute rejection in the analysis.||patients|||Number
704019|NCT00086346|Primary|Change From Baseline Adjusted Mean in Glomerular Filtration Rate (GFR)|GFR is an index of kidney function. GFR was calculated using Cockcroft-Gault method. A normal GFR is >90 mL/min, higher values indicate better function. Change=adjusted mean of 12 months minus baseline. Mean adjusted for baseline GFR, with antimetabolite therapy status and hepatitis C status as fixed effects.|Baseline and 12 months|The intent to treat population was analyzed and consisted of all patients randomly assigned to treatment. Patients were stratified by hepatitis C status and whether or not they were receiving antimetabolite therapy at time of randomization.||mL/min||Standard Error|Mean
704020|NCT00086385|Primary|Participants Abstinent From Cigarettes|Primary outcome variable was 7-day point prevalence cigarette abstinence verified biochemically at week 104|Two years|||participants|||Number
704021|NCT00086411|Secondary|Delineate Mediators Associated With Different Treatment Conditions (i.e., Medication Compliance, Participant Views of Self-help Written Materials and Counseling Type.||52 weeks||||||
704022|NCT00086411|Primary|Percent Treatment Sessions Attended|"Completion of Treatment and Smoking Cessation by Two Different Types of Medications and Counseling Types at 12, 26, and 52 Weeks Post-treatment Initiation. The counseling types were Medication Management (MM) and Mayo counseling models. MM counseling was a 4 session lower intensity counseling model and Mayo counseling was a 10 session higher intensity model.
A twofold definition of treatment completion included both medication and counseling session adherence. Treatment completion was defined as consistently taking the active medication as prescribed (80%) of the time during the medication period and attending at least 7 of the 10 required High C sessions or 3 of the 4 Low C sessions. Participants had to meet both requirements to be designated as full treatment completers.
Seven-day point prevalence abstinence was the primary measure of abstinence at follow-up Weeks 12, 24, and 52. Abstinence was confirmed by biochemical testing."|52 weeks|||Percentage of attended tx. sessions||Standard Error|Mean
704023|NCT00086450|Secondary|Rates of Individual MACCE Endpoints|Major adverse cardiovascular and cerebrovascular events|Measured at Day 30|||percentage of participants|||Number
704024|NCT00086450|Secondary|All-cause Mortality||Measured at Year 5|||percentage of participants|||Number
704025|NCT00086450|Secondary|Major MACCE Rates, Including the First of One of the Following: Death, Myocardial Infarction, Stroke, or Repeat Revascularization||Measured at Year 1|||percentage of participants|||Number
704026|NCT00086450|Primary|5-year Composite Endpoint of All-cause Mortality, Non-fatal Myocardial Infarction, and Stroke|median 3.8 years of follow-up|Measured at Year 5|||percentage of participants|||Number
704027|NCT00086502|Secondary|Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24|Change from baseline at Week 24 is defined as Week 24 minus Week 0.|Baseline and week 24|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last non-baseline observed measurement was carried forward to Week 24.||mg/dL||95% Confidence Interval|Least Squares Mean
704028|NCT00086502|Primary|Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24|HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent.|Baseline and week 24|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last non-baseline observed measurement was carried forward to Week 24.||Percent||95% Confidence Interval|Least Squares Mean
704225|NCT00098059|Primary|Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study.|A patient with multiple AEs within the primary system organ class is counted only once in total row.|Administered 2 times daily over 7 days|Includes 47 patients enrolled in Part B of the study.||participants|||Number
704029|NCT00086515|Secondary|Change From Baseline in 2-hour Post-meal Glucose (PMG) at Week 24|Change from baseline at Week 24 is defined as PMG at Week 24 minus PMG at Week 0.|Baseline and Week 24|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last non-baseline observed measurement was carried forward to Week 24.||mg/dL||95% Confidence Interval|Least Squares Mean
704030|NCT00086515|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|"Change from baseline at Week 24 is defined as FPG at
Week 24 minus FPG at Week 0."|Baseline and Week 24|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last non-baseline observed measurement was carried forward to Week 24.||mg/dL||95% Confidence Interval|Least Squares Mean
704031|NCT00086515|Primary|Change From Baseline in Hemoglobin A1C (A1C) at Week 24|"A1C is measured as a percent. Thus, this change from
baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent."|Baseline and Week 24|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last non-baseline observed measurement was carried forward to Week 24.||Percent||95% Confidence Interval|Least Squares Mean
704032|NCT00086580|Secondary|Participants With Minimal Residual Disease (MRD)|MRD negativity in this report was defined by the absence of tumor cells in bone marrow, using 4-color flow cytometry. MRD was assessed in participants with a clinical complete response (CR) or partial response (PR) without recovery of blood counts. MRD represents a very positive outcome.|up to 9 months|Full analysis set||participants|||Number
704033|NCT00086580|Secondary|Maximum Plasma Concentration (Cmax) of Fludarabine|Cmax is the maximum plasma concentration of fludarabine observed.|month 4 (cycle 4): first day of dosing (pre-dose, 0.5 hr end of infusion), second day of dosing (pre-dose, 0.5 hr end of infusion), third day of dosing (pre-dose, 0.25 hr, 0.5 hr end of infusion, 1,2,3,4,6,24,48,72 hr after start of fludarabine infusion)|Pharmacokinetic population||ng/mL||Standard Deviation|Mean
704034|NCT00086580|Secondary|Area Under the Curve (AUC) of Fludarabine From (AUC 0-tau)|AUC (0-tau) is the area under the plasma concentration curve for fludarabine over the dosage interval (tau).|month 4 (cycle 4): first day of dosing (pre-dose, 0.5 hr end of infusion), second day of dosing (pre-dose, 0.5 hr end of infusion), third day of dosing (pre-dose, 0.25 hr, 0.5 hr end of infusion, 1,2,3,4,6,24,48,72 hr after start of fludarabine infusion)|Pharmacokinetic population||ng*h/mL||Standard Deviation|Mean
704035|NCT00086580|Other Pre-specified|Kaplan-Meier Estimates of Overall Survival Time for Participants With Rai Stage III-IV|Overall survival was defined as the time in days from the date of randomization to the date of death due to any cause plus 1 day for all participants. Results are stated in months and include participants with Rai Stage III or IV.|Up to 6 years|Full analysis set of participants with Rai Stage III or IV||months||95% Confidence Interval|Median
704036|NCT00086580|Other Pre-specified|Kaplan-Meier Estimates of Overall Survival Time for Participants With Rai Stage I-II|Overall survival was defined as the time in days from the date of randomization to the date of death due to any cause plus 1 day for all participants. Results are stated in months and include participants with Rai Stage I or II.|Up to 6 years|Full analysis set of participants with Rai Stage I or II||months||95% Confidence Interval|Median
704037|NCT00086580|Other Pre-specified|Kaplan-Meier Estimates for Progression-free Survival (PFS) Based on Independent Response Review Panel (IRRP) for Participants With Rai Stage III-IV|Progression-free survival was defined as the number of days from the date of randomization to the date of first objective documentation of progressive disease (PD) as determined by the treatment-blinded IRRP, or death due to any cause. Results are expressed in months and include participants with Rai stage III or IV.|Up to 6 years|Full analysis set of participants with Rai stage III or IV||months||95% Confidence Interval|Median
704038|NCT00086580|Other Pre-specified|Kaplan-Meier Estimates for Progression-free Survival (PFS) Based on Independent Response Review Panel (IRRP) for Participants With Rai Stage I-II|Progression-free survival was defined as the number of days from the date of randomization to the date of first objective documentation of progressive disease (PD) as determined by the treatment-blinded IRRP, or death due to any cause. Results are expressed in months and include participants with Rai stage I or II.|Up to 6 years|Full analysis set of participants with Rai stage I or II||months||95% Confidence Interval|Median
704039|NCT00086580|Secondary|Total Volume of Distribution (Vss) of Fludarabine|The total volume of distribution (Vss) is the apparent volume in which fludarabine is distributed immediately after it has been injected intravenously and equilibrated between plasma and the surrounding tissues. Total volume of distribution (Vss) of fludarabine is derived from plasma concentration versus time data.|month 4 (cycle 4): first day of dosing (pre-dose, 0.5 hr end of infusion), second day of dosing (pre-dose, 0.5 hr end of infusion), third day of dosing (pre-dose, 0.25 hr, 0.5 hr end of infusion, 1,2,3,4,6,24,48,72 hr after start of fludarabine infusion)|Pharmacokinetic population||liters||Standard Deviation|Mean
704040|NCT00086580|Secondary|Mean Systemic Clearance (CL) of Fludarabine|Clearance of drug from plasma is affected by the absorption, distribution, metabolism and elimination of the drug. Mean systemic clearance of fludarabine is derived from plasma concentration versus time data.|month 4 (cycle 4): first day of dosing (pre-dose, 0.5 hr end of infusion), second day of dosing (pre-dose, 0.5 hr end of infusion), third day of dosing (pre-dose, 0.25 hr, 0.5 hr end of infusion, 1,2,3,4,6,24,48,72 hr after start of fludarabine infusion)|Pharmacokinetic population||liters/hour||Standard Deviation|Mean
704041|NCT00086580|Secondary|Summary of Participants With Adverse Experiences (AEs)|Number of participants with adverse events (AEs). AEs were graded by the investigator using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and were assessed for relatedness to study treatment (4 point scale from 'not related' to 'definitely related'). Categories reported include participant counts for treatment-emergent AEs, AEs for infections, serious AEs, AEs causing discontinuation of study drug(s), and deaths. Related AEs for the combination arm can be related to either fludarabine or alemtuzumab.|Up to 6 years|Safety population||participants|||Number
704226|NCT00098059|Primary|Apparent Terminal Elimination Half-life of Penciclovir (T1/2)|PK parameter; penciclovir is the active metabolite of famciclovir|Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose|Includes 26 of 27 patients enrolled in Part A of the study.||hours||Full Range|Mean
704042|NCT00086580|Secondary|Mean EuroQol Visual Analogue Scale (EQ-VAS) Scores to Measure Quality of Life at End of Treatment|"The EuroQol Visual Analogue Scale (EQ-VAS) was also used to capture the self-rating of current health status using a visual thermometer with the end points of 100 (best imaginable health state) at the top and zero (worst imaginable health state) at the bottom."|up to month 6 (end of treatment)|Full analysis set. Participants who provided valid answers on questionnaires are included.||units on a scale||Standard Deviation|Mean
704043|NCT00086580|Secondary|Mean EuroQol Visual Analogue Scale (EQ-VAS) Scores to Measure Quality of Life at Baseline|"The EuroQol Visual Analogue Scale (EQ-VAS) was also used to capture the self-rating of current health status using a visual thermometer with the end points of 100 (best imaginable health state) at the top and zero (worst imaginable health state) at the bottom."|Day 0 (baseline)|Full analysis set. Participants who provided valid answers on questionnaires are included.||units on a scale||Standard Deviation|Mean
704044|NCT00086580|Secondary|Mean EQ-5D™ Index Scores to Measure Quality of Life at End of Treatment|EQ-5D™ is a trademark of the EuroQol Group. EQ-5D™ is a standardized instrument for use as a measure of health outcome. The questionnaire asks about health status along 5 dimensions: mobility, self care, usual activities, pain/discomfort, and anxiety/depression, which are rated at three possible levels (no problems, some problems, extreme problems). The score ranges from best (+1) to worst (-0.59).|up to month 6 (end of treatment)|Full analysis dataset. Participants who provided valid answers on questionnaires are included.||units on a scale||Standard Deviation|Mean
704045|NCT00086580|Secondary|Mean EQ-5D™ Index Scores to Measure Quality of Life at Baseline|EQ-5D™ is a trademark of the EuroQol Group. EQ-5D™ is a standardized instrument for use as a measure of health outcome. The questionnaire asks about health status along 5 dimensions: mobility, self care, usual activities, pain/discomfort, and anxiety/depression, which are rated at three possible levels (no problems, some problems, extreme problems). The score ranges from best (+1) to worst (-0.59).|Day 0 (baseline)|Full analysis dataset. Participants who provided valid answers on questionnaires are included.||units on a scale||Standard Deviation|Mean
704046|NCT00086580|Secondary|Kaplan-Meier Estimates for Time to Alternative Therapy|Time to alternative therapy was defined as the number of days from the date of randomization to the date of first alternative therapy for chronic lymphocytic leukemia (CLL) or death resulting from any cause. Participants who had not received alternative therapy as of the data cutoff date were censored at the last follow-up visit assessment date plus 1 day. Results are stated in months.|Up to 6 years|Full analysis set||months||95% Confidence Interval|Median
704047|NCT00086580|Secondary|Kaplan-Meier Estimates for Duration of Response Assessed by the Independent Response Review Panel (IRRP)|Duration of response was analyzed for participants who achieved a complete response (CR) or partial response (PR) and was defined as the number of days from the first date of documented response to the date of progressive disease as determined by IRRP or death due to any cause. Results are stated in months.|Up to 6 years|Full analysis set of participants who achieved a complete response or a partial response as determined by the IRRP.||months||95% Confidence Interval|Median
704048|NCT00086580|Secondary|Kaplan Meier Estimates for Time to Disease Progression Assessed by the Independent Response Review Panel (IRRP)|Time to disease progression was defined as the number of days from the date of randomization to the date of first objective documentation of progressive disease as determined by IRRP. Results are stated in months.|Up to 6 years|Full analysis set||months||95% Confidence Interval|Median
704049|NCT00086580|Secondary|Kaplan-Meier Estimates of Overall Survival Time|Overall survival was defined as the time in days from the date of randomization to the date of death due to any cause plus 1 day for all participants. Results are stated in months.|Up to 6 years|Full analysis set||months||95% Confidence Interval|Median
704050|NCT00086580|Secondary|Participant Best Response to Treatment Assessed by the Independent Response Review Panel (IRRP)|Participants were evaluated by the IRRP according to National Cancer Institute (NCI) 1996 response criteria. The best response observed during the study is summarized. Response categories include Complete Response (CR) with normal physical exam, marrow cells and blood values, Partial Response (PR) with a >= 50% decrease from baseline in lymphocytes, lymphadenopathy and liver or spleen exam, Stable Disease (SD) without significant progression from baseline, or Progressive Disease (PD) with increased size/number of nodes, size of liver or spleen, increase in lymphocytes, aggressive histology.|Up to 9 months|Full analysis set||participants|||Number
704051|NCT00086580|Primary|Kaplan-Meier Estimates for Progression-free Survival (PFS) Based on Independent Response Review Panel (IRRP) Assessment|Progression-free survival was defined as the number of days from the date of randomization to the date of first objective documentation of progressive disease (PD) as determined by the treatment-blinded IRRP, or death due to any cause. Results are expressed in months.|Up to 6 years|Full analysis set||months||95% Confidence Interval|Median
704052|NCT00086619|Secondary|Change in Bone Mineral Density (BMD)|Percent change in BMD of the spine, femur, radius, and ulna, and subtotal body, calculated as 100*[(final - month 0)/month 0] in subjects who took study therapy for at least 12 months.|baseline and 18 months (12 months in 4 subjects)|Final BMD was measured after 18 months of study therapy in 48 subjects and measured after 12 months of study therapy in 4 others who thereafter dropped out prematurely. Of the latter 4, 3 were in the ascending dose arm and 1 was in the constant dose arm.||percent change||Standard Deviation|Mean
704053|NCT00086619|Primary|Changes in Indices of Bone Turnover|Change from month 0 (pre-treatment) baseline serum aminoterminal propeptide of type I collagen (PINP), osteocalcin (OC), and C-terminal telopeptide (CTX), expressed as an area under the curve (AUC). Each marker measurement result was multiplied by the corresponding subject-specific elapsed study time interval using the trapezoidal rule, and these products were summed to generate a subject-specific AUC (months*ng/ml) for the marker.|Each index of bone turnover was measured at study month 0, 1.5, 3, 6, 7.5, 9, 12, 13.5, 15, and 18.|Because this was a physiologic study evaluating the impact of stepwise increases in teriparatide, per protocol analysis was performed as was pre-specified in our analysis plan. Outcomes data were analyzed in women who remained on teriparatide throughout the first stepwise increase (i.e. until month 12 or later).||months*(ng/ml - baseline ng/ml)||Standard Deviation|Mean
704227|NCT00098059|Primary|Apparent Oral Clearance of Penciclovir (CL/F)|PK parameter; penciclovir is the active metabolite of famciclovir.|Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose|Includes 26 of 27 patients enrolled in Part A of the study.||L/h||Full Range|Mean
704374|NCT00099021|Secondary|Cyclin D1 and p21 Immune Histochemistry|Immune histochemistry / tissue staining for a possible biomarker.|Pre (Day 0) and Post (Week 12) Treatment||||||
704054|NCT00086684|Secondary|Number of Responders Defined as Having at Least a Four Point Reduction in the O’Leary-Sant Interstitial Cystitis Symptom Index (ICSI) From Baseline to Study Endpoint|The ICSI is a four-item self-administered instrument developed for the evaluation and management of patients with interstitial cystitis. The index measures the presence and extent of symptoms including urinary urgency, urinary frequency, nocturia and pain/burning in the bladder. Each question in the ICSI is on a 0-5 scale, where each answer is given a specific rating. The sum of the individual question ratings is the score for the ICSI. The range of the test is a score of 0 to 20. A lower score indicates a better condition.|Baseline to Week 24|Intent-to-Treat (ITT) Analysis set||participants|||Number
704055|NCT00086684|Primary|Number of Responders Defined as Having at Least a 30% Reduction in the O’Leary-Sant Interstitial Cystitis Symptom Index (ICSI) From Baseline to Study Endpoint|The ICSI is a four-item self-administered instrument developed for the evaluation and management of patients with interstitial cystitis. The index measures the presence and extent of symptoms including urinary urgency, urinary frequency, nocturia and pain/burning in the bladder. Each question in the ICSI is on a 0-5 scale, where each answer is given a specific rating. The sum of the individual question ratings is the score for the ICSI. The range of the test is a score of 0 to 20. A lower score indicates a better condition.|Baseline to Week 24|Intent-to-Treat (ITT) Analysis set||participants|||Number
704056|NCT00086957|Secondary|Overall Survival|Estimated using the product-limit method of Kaplan and Meier.|Until death from any cause, up to 5 years.|All patients treated at the phase II docetaxel dose (7 in the phase I portion, 22 in the phase II portion).||Months||95% Confidence Interval|Median
704057|NCT00086957|Secondary|Objective Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response Rate defined as percentage of patients achieving a Best Response of either CR or PR.|After 3 cycles of treatment, up to 2 years.|All patients treated at the phase II docetaxel dose (7 in the phase I portion, 22 in the phase II portion). Patients who complete 3 cycles of treatment or who terminate treatment for reasons of toxicity, or who progress prior to the completion of 3 cycles of therapy on the Phase II portion of the study.||percentage of participants|||Number
704058|NCT00086957|Secondary|Progression-free Survival|Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or the appearance of new lesions.|Until disease progression, up to 5 years.|All patients treated at the phase II docetaxel dose (7 in the phase I portion, 22 in the phase II portion).||Months||95% Confidence Interval|Median
704059|NCT00086957|Primary|Recommended Phase II Dose|The maximum tolerated dose (MTD): subjects received gefitinib 250 mg orally daily, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 75 mg/m^2 intravenously every 3 weeks. This was to serve as the phase II dose if no dose-limiting toxicities (DLTs) occurred in the first three subjects. If one DLT occurred in the first three subjects, another three subjects where to be enrolled at this dose, whereas if two DLTs occurred in the first three subjects, the docetaxel dose was to be decreased to 60 mg/m^2. The study would then be continued only if no more than one patient had a DLT at this dose. Once the dose of docetaxel was established, all further subjects were to be treated at the phase II MTD dose.|4 weeks from start of treatment, up to 2 years|All patients observed for 21 days while receiving a full course of therapy or who experienced a DLT. Patients withdrawing before completion of the first course, for reasons other than DLT, were replaced.||mg/m^2|||Number
704060|NCT00086957|Primary|Number of Participants With at Least One Dose Limiting Toxicity in Phase I|Dose Limiting Toxicity (DLT) defined as any treatment-related grade 3 or greater except for hematological toxicities which must be grade 4. Interstitial Lung Disease (ILD) related to treatment should be considered as a DLT regardless of the grade.|4 weeks from start of treatment, up to 2 years|All patients receiving treatment were evaluated for DLT.||participants with DLTs|||Number
704061|NCT00086996|Secondary|Progression-free Survival|measured from date of registration to time of first documentation of progression by Response Evaluation Criteria in Solid Tumors (RECIST), death, or last contact date.|0-3 years|eligible patients||months||95% Confidence Interval|Median
704062|NCT00086996|Secondary|Overall Survival|Measured from time of registration to death, or last contact date|0-5 years|eligible patients||months||95% Confidence Interval|Median
704063|NCT00086996|Secondary|Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Up to 3 years|Eligible patients who received any treatment and were assessed for toxicity were included in the adverse event summaries. Any Common Terminology Criteria for Adverse Events (CTCAE) v3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.||Participants|||Number
704064|NCT00086996|Primary|Pathological Complete Response|Complete pathologic response assessed after chemoradiotherapy and surgery, defined as no evidence of residual disease on path review. Patients who did not receive surgery are assumed to have not responded.|10-16 weeks after beginning study treatment|Eligible patients||participants|||Number
704065|NCT00087139|Secondary|Duration of Measurable Disease Response|Duration of measurable disease response was defined as the time from the date when measurement criteria were met for complete or partial response, whichever status was recorded first, until the first date that recurrent or progressive disease was objectively documented based on RECIST (Response Evaluation Criteria in Solid Tumors). Only patients with measurable disease response were included in this analysis.|Every 8 weeks during treatment; then every 3 months if <2 years from study entry; then every 6 months if 2-5 years from study entry|Only patients with measurable disease response were included in this analysis.||Months||95% Confidence Interval|Median
704078|NCT00087490|Secondary|Duration of Hospital Stay for mITT Population|Duration of Hospital Stay was defined as the number of days the participant was cared as an inpatient in the hospital during the maximum 34 days of the study period. The number of days in the hospital was counted from start of study medication to date of discharge or last date known to be in the hospital (for missing discharge dates and participants who died) or Day 34 for participants who continued hospitalization beyond EOS period.|Baseline up to EOS (6 to 28 days after the last dose of study drug)|mITT population included participants who received at least 1 dose of drug with appropriate diagnosis and MRSA as pathogen.||Days||Standard Error|Mean
704066|NCT00087139|Secondary|Duration of PSA Response|Duration of PSA response was defined as the time from the date of onset of PSA response until the date the criteria were met for PSA progression. Only patients with a PSA response were included in this analysis. The results were reported separately for 3 strata.|Every 4 weeks during treatment; then every 3 months if <2 years from study entry; then every 6 months if 2-5 years from study entry|If the regimen demonstrated a PSA response rate specified in the protocol, additional patients would be entered so the total number of eligible patients with measurable disease in each stratum is 25. But the PSA response related analysis was only done among the first cohort of patients, not including the additional patients with measurable disease.||Months||95% Confidence Interval|Median
704067|NCT00087139|Secondary|Proportion of Patients With Measurable Disease Response (Best Overall Response)|"Only patients with measurable disease were included in this analysis. The proportion of patients with measurable disease response (based on RECIST: Response Evaluation Criteria in Solid Tumors) was reported separately for 3 strata.
Per RECIST criteria, Complete response (CR)= disappearance of all target and nontarget lesions Partial response (PR)= >=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits.
Objective response = CR + PR"|Every 8 weeks during treatment; then every 3 months if <2 years from study entry; then every 6 months if 2-5 years from study entry|Only patients with measurable disease were included in this analysis.||proportion of participants||90% Confidence Interval|Number
704068|NCT00087139|Primary|Proportion of Patients With PSA Response|PSA response is defined as a decline from baseline value by >=50%, or normalization of PSA (PSA < 0.2 ng/lm), confirmed by a second measurement >= 4 weeks later. The proportion of patients with PSA response was reported separately for 3 strata. Additional patients accrued to this study were not included in this analysis.|Every 4 weeks during treatment; then every 3 months if <2 years from study entry; then every 6 months if 2-5 years from study entry|If the regimen demonstrated a PSA response rate specified in the protocol, additional patients would be entered so the total number of eligible patients with measurable disease in each stratum is 25. But the PSA response rate was only calculated among the first cohort of patients, not including the additional patients with measurable disease.||Proportion of participants||90% Confidence Interval|Number
704069|NCT00087152|Secondary|Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5= Fatal. Only adverse events that are possibly, probably or definitely related to study drug are reported.|Every 3 weeks while on treatment for up to 3 years.|Eligible participants who received any treatment.||Participants|||Number
704070|NCT00087152|Secondary|Progression-free Survival at 6 Months|Percentage of participants progression-free at 6 months. Progression-free survival (PFS) measured from date of registration to first observation of progressive disease (per RECIST criteria (V1.0)), death due to any cause, or symptomatic deterioration. Kaplan-Meier was used to estimate progression-free survival (PFS) at six months.|Six months|Eligible participants who received treatment.||percentage of participants||95% Confidence Interval|Number
704071|NCT00087152|Primary|Confirmed Response Rate (Complete and Partial)|Number of participants with confirmed complete or partial response. Confirmed response (complete and partial) per Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (V1.0). Complete Response (CR) is complete disappearance of all measurable and non-measurable disease; no new lesions; no disease related symptoms; and normalization of markers and other abnormal lab values. Partial response (PR) applies only to patients with at least one measurable lesion. PR is greater than or equal to 30% decrease under baseline of the sum of longest diameter of all target measurable lesions; no unequivocal progression of non-measurable disease and no new lesions. Confirmed response is two or more objective statuses a minimum of four weeks apart documented before progression or symptomatic deterioration.|12 weeks|Eligible participants who received treatment.||participants|||Number
704072|NCT00087438|Secondary|Rates of Local Recurrence, Regional Recurrence, Disseminated Recurrence, Disease-free and Overall Survival at 2 Years||From the start of treatment to 2 years||||||
704073|NCT00087438|Secondary|Treatment-related Grade 3 or 4 Toxicity||From the start of treatment to end of follow-up||||||
704074|NCT00087438|Primary|Local Control at 2 Years|Local control is defined as absence of local failure. (Detailed criteria for local failure is too long to include here.)|From the start of treatment to 2 years|Eligible patients who started protocol treatment.||percentage of subjects||95% Confidence Interval|Number
704075|NCT00087490|Secondary|Number of Participants Using Medical Resources|Medical resources utilization included a daily log of the participants’ location in the hospital and outside of the hospital (non-hospital location), adjusted duration of stay (difference between duration of stay and the duration of discharge delay) and daily log of study drug dosing.|Baseline up to EOS (6 to 28 days after the last dose of study drug)|Data was not analyzed for the primary reporting.||Participants|||Number
704076|NCT00087490|Secondary|Duration of Intravenous Therapy for mITT Population|Duration of intravenous antibiotic treatment was measured as the number of days intravenous doses of study medication was administered, before and after discharge.|Baseline up to EOS (6 to 28 days after the last dose of study drug)|"mITT population included participants who received at least 1 dose of drug with appropriate diagnosis caused by MRSA. N(number of participants analyzed)=participants evaluable for the measure."||Days||Standard Error|Mean
704077|NCT00087490|Secondary|Duration of Intravenous Therapy for PP Population|Duration of intravenous antibiotic treatment was measured as the number of days intravenous doses of study medication was administered, before and after discharge.|Baseline up to EOS (6 to 28 days after the last dose of study drug)|"PP set:who received at least 1 dose of drug,with appropriate diagnosis,MRSA as pathogen,satisfied all key inclusion/exclusion criteria, adequate dosing(failure:2 full days of drug, success:4 full days), observed outcome at EOS visit unless declared failure prior to visit.N(number of participants analyzed) = participants evaluable for the measure."||Days||Standard Error|Mean
704228|NCT00098059|Primary|Area Under the Penciclovir Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-∞)|PK parameter; penciclovir is the active metabolite of famciclovir.|Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose|Includes 26 of 27 patients enrolled in Part A of the study.||(μg/mL)h||Full Range|Mean
704375|NCT00099021|Secondary|Cyclooxygenase-2 Staining|Immune histochemistry / tissue staining for a possible biomarker.|Pre (Day 0) and Post (Week 12) Treatment||||||
704079|NCT00087490|Secondary|Duration of Hospital Stay for PP Population|Duration of Hospital Stay was defined as the number of days the participant was cared as an inpatient in the hospital during the maximum 34 days of the study period. The number of days in the hospital was counted from start of study medication to date of discharge or last date known to be in the hospital (for missing discharge dates and participants who died) or Day 34 for participants who continued hospitalization beyond EOS period.|Baseline up to EOS (6 to 28 days after the last dose of study drug)|PP set:who received at least 1 dose of drug,with appropriate diagnosis,MRSA as pathogen,satisfied all key inclusion/exclusion criteria, adequate dosing(failure:2 full days of drug, success:4 full days), observed outcome at EOS visit unless declared failure prior to visit.||Days||Standard Error|Mean
704080|NCT00087490|Secondary|Number of Participants With Clinical Signs and Symptoms at EOT and EOS for mITT Population|Participant’s clinical evaluation of signs and symptoms were based on global assessment by investigator at specific timepoints. Signs and symptoms of an active skin or soft tissue infection caused by suspected MRSA included purulent discharge, nonpurulent discharge, erythema, swelling, induration, tenderness, pain and local skin warmth. It was recorded using wound parameter score ranging from 0 to 3; “0= none, 1= mild, 2= moderate and 3= severe”.|EOT (within 72 hours of last dose of study drug), EOS (6 to 28 days after the last dose of study drug)|mITT population included participants who received at least 1 dose of drug with appropriate diagnosis caused by MRSA. Here, 'n' signified participants who were evaluable and analyzed for specific clinical signs and symptoms.||Partcipants|||Number
704081|NCT00087490|Secondary|Number of Participants With Clinical Signs and Symptoms at EOT and EOS for PP Population|Participant’s clinical evaluation of signs and symptoms were based on global assessment by investigator at specific timepoints. Signs and symptoms of an active skin or soft tissue infection caused by suspected MRSA included purulent discharge, nonpurulent discharge, erythema, swelling, induration, tenderness, pain and local skin warmth. It was recorded by the sponsor using wound parameter score ranging from 0 to 3; “0= none, 1= mild, 2= moderate and 3= severe”.|EOT (within 72 hours of last dose of study drug), EOS (6 to 28 days after the last dose of study drug)|PP set:who received at least 1 dose of drug, with appropriate diagnosis,MRSA as pathogen, satisfied all key inclusion/exclusion criteria, adequate dosing(failure:2 full days of drug, success:4 full days),observed outcome at EOS visit unless declared failure prior to the visit.Here,'n'=participants evaluable for specific clinical signs and symptoms.||Participants|||Number
704082|NCT00087490|Secondary|Microbiological Outcome in Participants With Baseline MRSA at EOT for mITT Population|Microbiological outcome dichotomized to “success” (eradication: absence of baseline isolate (BI) in culture of original infection site (IS); presumed eradication: participant cured and no specimen available for culture; superinfection: clinically failed or improved with new pathogen identified from primary IS other than BI; colonization: isolate was present but not producing infection) and “failure” (persistence: BI present in original IS; presumed persistence: clinically failed and no specimen available for culture).|EOT (within 72 hours of last dose of study drug)|"mITT population included participants who received at least 1 dose of drug with appropriate diagnosis and MRSA as pathogen.N(number of participants analyzed)= participants evaluable for the measure."||Percentage of participants|||Number
704083|NCT00087490|Secondary|Microbiological Outcome in Participants With Baseline MRSA at EOS for mITT Population|Microbiological outcome dichotomized to “success” (eradication: absence of baseline isolate (BI) in culture of original infection site (IS); presumed eradication: participant cured and no specimen available for culture; superinfection: clinically failed or improved with new pathogen identified from primary IS other than BI; colonization: isolate was present but not producing infection) and “failure” (persistence: BI present in original IS; presumed persistence: clinically failed and no specimen available for culture; recurrence: presence of isolate at EOS, that was eradicated at EOT).|EOS (6 to 28 days after the last dose of study drug)|"mITT population included participants who received at least 1 dose of drug with appropriate diagnosis and MRSA as pathogen.N(number of participants analyzed)= participants evaluable for the measure."||Percentage of participants|||Number
704084|NCT00087490|Secondary|Microbiological Outcome in Participants With Baseline MRSA at EOT for PP Population|Microbiological outcome dichotomized to “success” (eradication: absence of baseline isolate (BI) in culture of original infection site (IS); presumed eradication: participant cured and no specimen available for culture; superinfection: clinically failed or improved with new pathogen identified from primary IS other than BI; colonization: isolate was present but not producing infection) and “failure” (persistence: BI present in original IS; presumed persistence: clinically failed and no specimen available for culture).|EOT (within 72 hours of last dose of study drug)|"PP (EOT)set:who received at least 1 dose of drug,with appropriate diagnosis,MRSA as pathogen,satisfied all key inclusion/exclusion criteria,adequate dosing(failure:2 full days of drug,success:4 full days),observed outcome at EOT visit unless declared failure prior to visit.N(number of participants analyzed)=participants evaluable for the measure."||Percentage of participants|||Number
704085|NCT00087490|Secondary|Microbiological Outcome in Participants With Baseline MRSA at EOS for PP Population|Microbiological outcome dichotomized to “success” (eradication: absence of baseline isolate (BI) in culture of original infection site (IS); presumed eradication: participant cured and no specimen available for culture; superinfection: clinically failed or improved with new pathogen identified from primary IS other than BI; colonization: isolate was present but not producing infection) and “failure” (persistence: BI present in original IS; presumed persistence: clinically failed and no specimen available for culture; recurrence: presence of isolate at EOS, that was eradicated at EOT).|EOS (6 to 28 days after the last dose of study drug)|"PP (EOS)set:who received at least 1 dose of drug, with appropriate diagnosis,MRSA as pathogen,satisfied all key inclusion/exclusion criteria, adequate dosing(failure:2 full days of drug, success:4 full days), observed outcome at EOS unless declared failure prior to visit.N(number of participants analyzed)=participants evaluable for the measure."||Percentage of participants|||Number
704096|NCT00087529|Secondary|Change From Baseline to Week 96 in Brain Volume on MRI Scan|Scheduled MRI scans of the brain and cervical spinal cord were performed with and without gadolinium contrast at Screening and Week 6, and without gadolinium at Weeks 48, 96, and 122 and/or upon early termination. The total brain volume was documented at Baseline and at visits occurring during Weeks 48 and 96. Missing Week 96 values were imputed using a LOCF approach, while participants with missing Baseline values were excluded. The change in brain volume was calculated as [volume at Week 96 minus volume at Baseline] and expressed in cubic centimeters (cm^3).|At Baseline and Week 96|ITT Population. Participants with missing Baseline values were excluded.||cm^3||Full Range|Median
704086|NCT00087490|Secondary|Clinical Outcome in Participants With Baseline MRSA at EOT for mITT Population|CR evaluated at EOT visit as “success” (cure: resolution of clinical sign/symptoms of infection when compared with baseline; and improvement: 2/more improvement in clinical sign/symptoms of infection when compared with baseline); “failure”: persistence/progression of baseline signs/symptoms of infection after at least 2 days of treatment/development of new clinical findings consistent with active infection; “unknown”: extenuating circumstances precluding classification to 1 of above. “Unknown”: excluded from present analysis.|EOT (within 72 hours of last dose of study drug)|"mITT population included participants who received at least 1 dose of drug with appropriate diagnosis and MRSA as pathogen.N(number of participants analyzed)= participants evaluable for the measure."||Percentage of participants|||Number
704087|NCT00087490|Secondary|Clinical Outcome in Participants With Baseline MRSA at EOS for Modified-Intent to Treat (mITT) Population|CR was based primarily on global assessment of clinical presentation of participant made by investigator at evaluation time point. At EOS, CR was evaluated as “success” (cure: resolution of clinical signs/symptoms of infection when compared to baseline); “failure”: persistence/progression of baseline signs/symptoms of infection after at least 2 days of treatment/development of new clinical findings consistent with active infection; “unknown”: extenuating circumstances precluding classification to 1 of above. “Unknown” was excluded from present analysis.|EOS (6 to 28 days after the last dose of study drug)|"mITT population included participants who received at least 1 dose of drug with appropriate diagnosis and MRSA as pathogen.N(number of participants analyzed)= participants evaluable for the measure."||Percentage of participants|||Number
704088|NCT00087490|Secondary|Clinical Outcome in Participants With Baseline MRSA at End of Treatment (EOT) for PP Population|CR evaluated at EOT visit as “success” (cure: resolution of clinical sign/symptoms of infection when compared with baseline; and improvement: 2/more improvement in clinical sign/symptoms of infection when compared with baseline); “failure”: persistence/progression of baseline signs/symptoms of infection after at least 2 days of treatment/development of new clinical findings consistent with active infection; “unknown”: extenuating circumstances precluding classification to 1 of above. “Unknown”: excluded from present analysis.|EOT (within 72 hours of last dose of study drug)|"PP (EOT)set:who received at least 1 dose of drug,with appropriate diagnosis,MRSA as pathogen,satisfied all key inclusion/exclusion criteria,adequate dosing(failure:2 full days of drug,success:4 full days),observed outcome at EOT visit unless declared failure prior to visit.N(number of participants analyzed)=participants evaluable for the measure."||Percentage of participants|||Number
704089|NCT00087490|Primary|Clinical Outcome in Participants With Baseline Methicillin-Resistant Staphylococcus Aureus (MRSA) at End of Study (EOS) for Per-Protocol (PP) Population|Clinical response (CR) was based primarily on global assessment of clinical presentation of participant made by investigator at evaluation time point. At EOS, CR was evaluated as “success” (cure: resolution of clinical signs or (/) symptoms of infection when compared to baseline); “failure”: persistence/progression of baseline signs/symptoms of infection after at least 2 days of treatment/development of new clinical findings consistent with active infection; “unknown”: extenuating circumstances precluding classification to 1 of above. “Unknown” was excluded from present analysis.|EOS (6 to 28 days after the last dose of study drug)|"PP (EOS)set:who received at least 1 dose of drug, with appropriate diagnosis,MRSA as pathogen,satisfied all key inclusion/exclusion criteria, adequate dosing(failure:2 full days of drug, success:4 full days), observed outcome at EOS unless declared failure prior to visit.N(number of participants analyzed)=participants evaluable for the measure."||Percentage of participants|||Number
704090|NCT00087516|Secondary|Change From Baseline in 2-hr PMG at Week 104|Change from baseline at Week 104 is defined as Week 104 2-hr PMG minus Week 0 2-hr PMG.|Weeks 0-104|The all-patients-treated population for Week 104, included all patients with at least one dose of double-blind study therapy after Week 24, and with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. Missing data were handled using the last observation carrying forward method.||mg/dL||95% Confidence Interval|Least Squares Mean
704091|NCT00087516|Secondary|Change From Baseline in FPG at Week 104|Change from baseline at Week 104 is defined as Week 104 FPG minus Week 0 FPG.|Weeks 0-104|The all-patients-treated population for Week 104, included all patients with at least one dose of double-blind study therapy after Week 24, and with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. Missing data were handled using the last observation carrying forward method.||mg/dL||95% Confidence Interval|Least Squares Mean
704092|NCT00087516|Secondary|Change From Baseline in A1C at Week 104|A1C is measured as a percent. Thus, this change from baseline reflects the Week 104 A1C percent minus the Week 0 A1C percent.|Weeks 0-104|The all-patients-treated population for Week 104 included all patients with at least one dose of double-blind study therapy after Week 24, and with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. Missing data were handled using the last observation carrying forward method.||Percent||95% Confidence Interval|Least Squares Mean
704093|NCT00087516|Secondary|Change From Baseline in 2-hour Post-meal Glucose (2-hr PMG) at Week 24|Change from baseline at Week 24 is defined as Week 24 2-hr PMG minus Week 0 2-hr PMG.|Weeks 0-24|The all-patients-treated population included all patients with at least one dose of double-blind study therapy, and with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. Missing data were handled using the last observation carrying forward method.||mg/dL||95% Confidence Interval|Least Squares Mean
704094|NCT00087516|Secondary|Change From Baseline in FPG at Week 24|Change from baseline at Week 24 is defined as Week 24 FPG minus Week 0 FPG.|Weeks 0-24|The all-patients-treated population included all patients with at least one dose of double-blind study therapy, and with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. Missing data were handled using the last observation carrying forward method.||mg/dL||95% Confidence Interval|Least Squares Mean
704095|NCT00087516|Primary|Change From Baseline in A1C at Week 24|A1C is measured as a percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.|Weeks 0-24|The all-patients-treated population included all patients with at least one dose of double-blind study therapy, and with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. Missing data were handled using the last observation carrying forward method.||Percent||95% Confidence Interval|Least Squares Mean
704097|NCT00087529|Secondary|Change From Baseline to Week 96 in Total Volume of Transverse Relaxation Time (T2) Brain Lesions on Magnetic Resonance Imaging (MRI) Scan|Scheduled T2-weighted MRI scans of the brain and cervical spinal cord were performed with and without gadolinium contrast at Screening and Week 6, and without gadolinium at Weeks 48, 96, and 122 and/or upon early termination. The total volume of T2 (ie, hyperintense) brain lesions at each visit was documented. Missing Week 96 values were imputed using a last observation carried forward (LOCF) approach, while participants with missing Baseline values were excluded. The change in T2 lesion volume was calculated as [volume at Week 96 minus volume at Baseline] and expressed in cubic millimeters (mm^3).|At Baseline and Week 96|ITT Population. Participants with missing Baseline values were excluded.||mm^3||Full Range|Median
704098|NCT00087529|Primary|Percentage of Participants With CDP|Disease progression was assessed using the EDSS, a disability scale that ranges from 0 to 10, where higher scores represent increased disability. Progression was defined as either an increase of ≥1 point from a Baseline EDSS score within 2.0 to 5.5 points, or an increase of ≥0.5 points from a Baseline EDSS score >5.5 points, for which the change was not attributable to another etiology. Repeat assessment to determine CDP must have occurred at a regularly scheduled visit at least 12 weeks after initial progression; those who discontinued treatment early without confirmatory EDSS assessment were considered as having CDP. The percentage of participants with CDP was calculated as [number of participants meeting the above criteria divided by the number analyzed] multiplied by 100.|96 weeks (from Screening to Week 96, and at least 12 weeks after initial progression)|ITT Population.||percentage of participants|||Number
704099|NCT00087529|Primary|Time to Confirmed Disease Progression (CDP)|Disease progression was assessed using the Expanded Disability Status Scale (EDSS), a disability scale that ranges from 0 to 10, where higher scores represent increased disability. Progression was defined as either an increase of greater than or equal to (≥) 1 point from a Baseline EDSS score within 2.0 to 5.5 points, or an increase of ≥0.5 points from a Baseline EDSS score greater than (>) 5.5 points, for which the change was not attributable to another etiology. Repeat assessment to determine CDP must have occurred at a regularly scheduled visit at least 12 weeks after initial progression; those who discontinued treatment early without confirmatory EDSS assessment were considered as having CDP. Those who did not meet criteria for CDP, completed treatment with only initial progression, or received an exclusionary therapy were censored at last EDSS assessment. Time to CDP was the time from randomization to initial disease progression, estimated using Kaplan-Meier (KM) analysis.|96 weeks (from Screening to Week 96, and at least 12 weeks after initial progression)|ITT Population.||weeks||95% Confidence Interval|Median
704100|NCT00087555|Primary|The Primary Outcome Measure Was a Composite of Changes From Baseline in Three Co-primary Self Report Measures: Pain Visual Analog Scale (PVAS, Electronic Diaries), Fibromyalgia Impact Questionnaire (FIQ), and Patient Global Impression of Change (PGI-C).|"The percentage of participants who met all 3 of the following criteria:
Reduction of >=20% from baseline to week 8 in both PVAS & FIQ total score and PGI-C response of very much better or much better. Analysis was based on LOCF (Last Observation Carried Forward) data. The PVAS ranges from 0 (no pain) to 100 (worst imaginable pain). The FIQ ranges from 0 (best function) to 100 (worst function). PGI-C is a 7 point likert scale measuring change in the participant's fibromyalgia symptoms that ranges from very much worse to very much better"|Baseline to week 8|||Percentage of Participants|||Number
704101|NCT00087568|Secondary|Mean Score for Overall Local Injection Site Reaction|Local injection-site reactions were to be given an overall assessment based on pain or discomfort as Grade 0 for no pain or discomfort, Grade 1 for mild tenderness at the injection site, Grade 2 for moderate pain without limitation of usual activities, Grade 3 for severe pain requiring prescription non-topical analgesics or limiting usual activities, Grade 4 for a reaction that resulted in a new hospitalization, prolongation of hospitalization, death, or a persistent or significant disability/incapacity, or was life threatening or medically significant. Adverse events related to the injection site (injection site erythema, hematoma, pain, rash, or reaction) were reported. All of these events were reported as resolved without sequelae.|Baseline (Week 0), Week 4, 12, 24, 36, 48 and 60|Safety Population included all enrolled participants who received at least one dose of study medication and had at least one post-baseline safety assessment (a clinical adverse event, laboratory, vital sign, or physical examination finding, BDI-II score, or FSS score). 'n' = number of participants available at the time of assessment.||Units on a scale||Standard Deviation|Mean
704102|NCT00087568|Secondary|Number of Participants With Abnormal Vital Signs|"Abnormal vital signs were defined as
Systolic blood pressure (BP) below 85 mm Hg or above 180 mm Hg with a change from baseline of > 20%
Diastolic BP above 110 mm Hg with a change from baseline of > 20% where systolic and diastolic BP were pressure exerted by blood on the walls of blood vessels during left ventricular systole and diastole respectively.
Pulse rate below 50 beats per minute and above 120 beats per minute, with a change from baseline of > 20%, where pulse represents the palpation of heartbeat"|From screening (Day -21 to Day -1) to Week 84|Safety Population included all enrolled participants who received at least one dose of study medication (Pegasys or ribavirin) and had at least one post-baseline safety assessment (defined as clinical adverse event, laboratory or vital sign data, physical examination finding, BDI-II score, or FSS score).||Participants|||Number
704103|NCT00087568|Secondary|Number of Participants With Marked Laboratory Abnormalities|Analysis was performed for hematology, clinical chemistry, thyroid function, and urinalysis. Normal ranges of the parameters were: Haematocrit (fraction): 0.37 - 0.49, Haemoglobin (g/L): 130 - 180 , Platelets (G/L): 150 - 350, White blood cell (G/L): 4.5 - 11.0, Lymphocytes (G/L): 1.00 - 4.80, Neutrophils (G/L): 1.80 - 7.70, Prothrombin Time in Seconds (sec): not defined, Prothrombin Time, normalized (ratio): 0.70 - 1.30, Partial thromboplastin Time (sec): 22.1 - 34.1, Aspartate transaminase (AST) or serum glutamate oxaloacetate transaminase (SGOT) in IU/L: 0 - 40, Alkaline Phosphatase (IU/L): 0 - 115, ALT or serum glutamate pyruvate transaminase (SGPT) in (IU/L): 0-55, Total Bilirubin (umol/L): 0 -17, Thyroxine (T4) (nmol/L): 58 -140, Thyroid-stimulating hormone (TSH, [U/mL]): 0.0 - 5.0, Triglycerides (mmol/L): 0.45 - 1.69, Phosphate (mmol/L): 0.84 - 1.45, Uric Acid (umol/L): 214 - 506|Up to Week 84|Safety Population included all the enrolled participants who received at least one dose of study medication and had at least one post-baseline safety assessment (a clinical adverse event, laboratory, vital sign, or physical examination finding, BDI-II score, or FSS score). 'n' = number of participants available at the time of assessment.||participants|||Number
704376|NCT00099021|Secondary|Pigliotazone Gamma Immune Histochemistry|Immune histochemistry / tissue staining for a possible biomarker.|Pre (Day 0) and Post (Week 12) Treatment||||||
704104|NCT00087568|Secondary|Number of Participants With Individual Flu-like Symptom|Participants were asked to complete a flu-like symptom questionnaire at screening, study baseline, and at all subsequent scheduled visits. The “yes/no” questionnaire evaluated the incidence of headache, fever, myalgia, and chills. If a participant answered “yes” to the question “Has the patient experienced any flu-like symptoms since the last visit?” all among headache, fever, muscle aches (myalgia), and chills that applied were to be marked. If any of the experienced symptoms was newly reported or had worsened, a corresponding adverse event was to be reported.|Baseline (Week 0); Weeks 12, 36, 60 and 84|Safety Population included all the enrolled participants who received at least one dose of study medication and had at least one post-baseline safety assessment (a clinical adverse event, laboratory or vital sign data, physical examination data, BDI-II score, or FSS score). n = number of participants available at the particular time of assessment.||Participants|||Number
704105|NCT00087568|Secondary|Mean Score of Fatigue Severity Over Time|The Fatigue severity score (FSS) scale has a series of questions designed to assess tiredness, lack of energy, or total body give-out. Participants were to react to nine statements regarding fatigue over the previous 2 weeks, each on a scale (1 = completely agree, 7 = completely disagree). The FSS is the average of the scores on the 9 questions; ranging from 1-7, with lower scores indicating less fatigue. In addition, participants were to react to how much fatigue they had in the past 2 or 4 weeks by marking on a visual analogue scale labelled at one end with “no fatigue” (‘0’ being the best) and at the other end with “greater fatigue” (‘100’ being the worst). Longer distance on the scale from “no fatigue” indicated “greater fatigue”. FSS values are presented based on questionnaire and visual analog scale.|Baseline (Week 0); Weeks 4, 12, 24, 36, 48, 60, and 84|Safety Population included all the enrolled participants who received at least one dose of study medication and had at least one post-baseline safety assessment (a clinical adverse event, laboratory or vital sign data, physical examination finding, or FSS score). n = number of participants available at the particular time for assessment.||Units on a scale||Standard Deviation|Mean
704106|NCT00087568|Secondary|Mean Score of Beck Depression Inventory Over Time|The Beck Depression Inventory (BDI-II) is a questionnaire with groups of statements in which the patient is asked to select the statement that most clearly describes the way he/she has felt in the past two weeks, including today. The score for each group is tallied and the ranges of scores are used as guidelines for measuring the degree of depression. For this study, scores are defined as follows: 0 to 15 as minimal, 16 to 21 as mild, 22 to 30 as moderate, and 31 to 63 as severe. The questionnaire was in two areas (changes in sleeping pattern and changes in appetite), selections 1, 2, and 3 contained options for both more and less with respect to the area of interest. Four statements (labelled 0, 1, 2, and 3) were offered that described the area of interest, with 0 indicating no effect and 3 indicating the worst effect. The individual area scores were summed to provide a total score.|Baseline (Week 0); Weeks 4, 12, 24, 36, 48, 60, and 84|Safety Population included all enrolled participants who received at least one dose of study drug and had at least one post-baseline safety assessment (a clinical adverse event, laboratory or vital sign data, physical examination finding, BDI-II score, or FSS score). n = number of participants available at the particular time for assessment.||Units on a scale||Standard Deviation|Mean
704107|NCT00087568|Secondary|Number of Participants With Serious Adverse Events and Adverse Events|An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An adverse event could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Pre-existing conditions that worsened during the study were also to be reported as adverse events. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is medically significant or requires intervention to prevent one or other of the outcomes listed above.|Up to Week 84|Safety Population included all enrolled participants who received at least one dose of study medication (Pegasys or ribavirin) and had at least one post-baseline safety assessment (defined as clinical adverse event, laboratory or vital sign data, physical examination finding, BDI-II score, or FSS score).||Participants|||Number
704108|NCT00087568|Secondary|Number of Participants With Normal Serum Alanine Transaminase Levels Over Time|The number of participants with serum alanine transaminase (ALT) concentration within the normal range at each time point assessed. Upper limit of normal serum ALT for men is 43 International units per liter (IU/L) and for women is 34 IU/L.|Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, and 84|ITT Population included all enrolled participants who received at least one dose of study medication (Pegasys or ribavirin).||Participants|||Number
704109|NCT00087568|Secondary|Number of Participants With >=2-log10 Decrease or Undetectable (<60 International Units Per Milliliter) Hepatitis C Virus-ribonucleic Acid Over Time|Sustained virological response (SVR) is defined as undetectable Hepatitis C virus-ribonucleic acid (HCV RNA)(<60 International units per milliliter) or HCV RNA for >=2-log10 decrease in viral titre, 24 weeks after the end of treatment. A participant was classified as non-responder (SVR not achieved) if HCV RNA was detectable at the completion of antiviral treatment, at Week 24 post or at any time between Week 24 and completion of antiviral treatment. HCV RNA measured prior to or on the date of the first dose of Pegasys plus ribavirin was used as the baseline in all HCV RNA analyses.|Weeks 4, 12, 24, 36, 48, 60, and 84|Intent to treat (ITT) Population included all enrolled participants who received at least one dose of study medication (Pegasys or ribavirin).||Participants|||Number
704117|NCT00087594|Secondary|Number of Participants With Degrees of Depression as Defined by the BDI-II Score|Participants with degrees of depression as defined by the BDI-II Score were reported. BDI-II is 21-item self-report instrument to assess severity of symptoms of depression. There is a four-point scale for each item ranging from 0 to 3. Degrees of depression defined by the total BDI-II score as: minimal (0 to 13), mild (14 to 19), moderate (20 to 28), and severe depression (>= 29). Higher scores reflective of greater severity (worse outcome).|Up to Week 72|Safety Population included all participants who received at least one dose of study treatment and have at least one post-baseline safety assessment (adverse event, laboratory/vital sign, physical examination; Beck Depression Inventory; Hepatitis Quality-of-Life Questionnaire). n = number of participants at indicated time points for each arm.||participants|||Number
704377|NCT00099021|Secondary|Apotosis (Cell Death)|Immune histochemistry / tissue staining for a possible biomarker.|Pre (Day 0) and Post (Week 12) Treatment||||||
704110|NCT00087568|Primary|Number of Pegasys and Ribavirin Therapy Completers|Therapy completers were defined as all participants who had demonstrable viremia after 12 weeks of Pegasys plus ribavirin therapy (who were to be discontinued for lack of efficacy), non-tolerators who completed 36 weeks of Pegasys plus ribavirin therapy, and non-responders who completed 60 weeks of Pegasys plus ribavirin therapy. Study completers included all participants who completed the planned treatment period (36 weeks for non-tolerators and 60 weeks for non-responders) and the 24-week treatment-free follow-up period and participants in either group who were prematurely discontinued per protocol due to insufficient therapeutic response at Week 12.|36 weeks for Non-Tolerators and 60 weeks for Non-Responders|Safety Population included all enrolled participants who received at least one dose of study medication (Pegasys or ribavirin) and had at least one post-baseline safety assessment which defined as clinical adverse event, laboratory or vital sign data, physical examination finding, Beck Depression Inventory (BDI-II), or Fatigue severity score (FSS).||Participants|||Number
704111|NCT00087594|Secondary|Number of Participants With Any Adverse Events (AEs), Any Serious Adverse Events (SAEs), and Study Discontinuation|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect. Reason for discontinuation was categorized as safety and non-safety, where safety reasons included abnormality of laboratory tests, AEs, and death; and non-safety reasons included insufficient therapeutic response, early improvement, violation of selection criteria at entry, other protocol violation, refused treatment, failure to return and other. Participants who discontinued the study with any reason were recorded.|Up to 24 weeks post treatment (Week 48 for G2/3 and Week 72 for G1)|Safety Population included all participants who received at least one dose of study treatment and have at least one post-baseline safety assessment (adverse event, laboratory/vital sign, physical examination; Beck Depression Inventory; Hepatitis Quality-of-Life Questionnaire). n = number of participants at indicated time points for each arm.||participants|||Number
704112|NCT00087594|Secondary|Number of Participants With Marked Laboratory Abnormalities (Biochemistry)|"Laboratory values falling outside the marked reference range as defined by Roche's International Guideline for the Handling and Reporting of Laboratory Data”, and were clinically relevant change from baseline were considered marked laboratory abnormalities. It was reported as low or high abnormal."|Up to 24 weeks post treatment (Week 48 for G2/3 and Week 72 for G1)|Safety Population included all participants who received at least one dose of study treatment and have at least one post-baseline safety assessment (adverse event, laboratory/vital sign, physical examination; Beck Depression Inventory; Hepatitis Quality-of-Life Questionnaire). n = number of participants at indicated time points for each arm.||participants|||Number
704113|NCT00087594|Secondary|Number of Participants With Marked Laboratory Abnormalities (Hematology)|"Hematology included hematocrit (fraction), hemoglobin, platelets count, Red blood cells (RBC), White blood cell (WBC), eosinophils, lymphocytes, monocytes, neutrophils, Partial Thromboplastin time (PTT), Prothrombin Time International Normalized Ratio (PT INR). Laboratory values falling outside the marked reference range as defined by Roche's International Guideline for the Handling and Reporting of Laboratory Data”, and were clinically relevant change from baseline were considered marked laboratory abnormalities. It was reported as low or high abnormal."|Up to 24 weeks post treatment (Week 48 for G2/3 and Week 72 for G1)|Safety Population included all participants who received at least one dose of study treatment and have at least one post-baseline safety assessment (adverse event, laboratory/vital sign, physical examination; Beck Depression Inventory; Hepatitis Quality-of-Life Questionnaire). n = number of participants at indicated time points for each arm.||participants|||Number
704114|NCT00087594|Secondary|Number of Participants With Abnormal Vital Signs|Vital Signs included systolic blood pressures (SBP), diastolic blood pressures (DBP), and pulse rate (PR). Abnormal vital signs were reported as low or high abnormal. It was defined as < 85 mm Hg or > 180 mm Hg with a change from baseline of > 20%; DBP as > 110 mm Hg with a change from baseline of > 20%; and PR as < 50 bpm and > 120 bpm with a change from baseline of > 20%.|Up to 24 weeks of treatment-free follow-up visit (Week 48 for G2/3 and Week 72 for G1)|Safety Population included all participants who received at least one dose of study treatment and have at least one post-baseline safety assessment (adverse event, laboratory/vital sign, physical examination; Beck Depression Inventory; Hepatitis Quality-of-Life Questionnaire). n = number of participants at indicated time points for each arm.||participants|||Number
704115|NCT00087594|Secondary|Number of Participants With Compliance to the Prescribed Treatment Regimen|Participants with compliance to the prescribed treatment regimen for peginterferon alfa-2a and ribavirin was reported. Compliance was calculated as (total cumulative dose taken) / (total cumulative original dose prescribed for the entire study) x 100. Total treatment duration = Maximum doses of peginterferon alfa-2a and ribavirin in days / (48*7) for G1, total treatment duration = Maximum doses of peginterferon alfa-2a and ribavirin in days / (24*7) for G2/3.|Up to Week 24 for G 2/3; up to Week 48 for G1|Safety Population included all participants who received at least one dose of study treatment and have at least one post-baseline safety assessment (adverse event, laboratory/vital sign, physical examination; Beck Depression Inventory; Hepatitis Quality-of-Life Questionnaire). n = number of participants at indicated time points for each arm.||participants|||Number
704116|NCT00087594|Secondary|Mean Absolute Scores for Hepatitis Quality-of-Life Questionnaire (HQLQ) at EOT (Week 24/48) Visit and 24 Weeks After EOT Visit|The HQLQ is a multiple-choice questionnaire includes the eight individual qualify-of-life scales of the Medical Outcomes Study 36-item Short-form Health Survey as: Social functioning (SF), role limitations due to emotional problems (RE), vitality (VT), general mental health (MH), physical functioning (PF), role limitations due to physical problems (RP), freedom from bodily pain (BP), and general health (GH). In addition, two other generic scales (positive well-being [PWB] and health distress [HD]) and two hepatitis-specific scales (limitations because of chronic hepatitis C [HLIM] and health distress because of chronic hepatitis C [HHD]) were included. Scores were scaled to a 0 to 100 range, with 0 = bad and 100 = good. A higher score indicates an improvement.|Baseline (Day -30 to -1), 24 weeks after EOT visit (Week 48 for G2/3 and Week 72 for G1)|Safety Population included all participants who received at least one dose of study treatment and have at least one post-baseline safety assessment (adverse event, laboratory/vital sign, physical examination; Beck Depression Inventory; Hepatitis Quality-of-Life Questionnaire). n = number of participants at indicated time points for each arm.||units on a scale||Standard Error|Mean
704118|NCT00087594|Secondary|Mean Change From Baseline in BDI-II Score to EOT (Week 24/48) and EOS (Week 48/72) Visits|BDI-II is 21-item self-report instrument to assess severity of symptoms of depression. There is a four-point scale for each item ranging from 0 to 3. Degrees of depression defined by the total BDI-II score as: minimal (0 to 13), mild (14 to 19), moderate (20 to 28), and severe depression (>= 29). Higher scores reflective of greater severity (worse outcome).|Baseline (Day -30 to -1), EOT visit (Week 24 for G2/3 and Week 48 for G1), and end of study (EOS) visit (Week 48 for G2/3 and Week 72 for G1)|Safety Population included all participants who received at least one dose of study treatment and have at least one post-baseline safety assessment (adverse event, laboratory/vital sign, physical examination; Beck Depression Inventory; Hepatitis Quality-of-Life Questionnaire). n = number of participants at indicated time points for each arm.||units on a scale||Standard Error|Mean
704119|NCT00087594|Secondary|Mean Absolute Score of Beck Depression Inventory, Second Edition (BDI-II)|BDI-II is 21-item self-report instrument to assess severity of symptoms of depression. There is a four-point scale for each item ranging from 0 to 3. Degrees of depression defined by the total BDI-II score as: minimal (0 to 13), mild (14 to 19), moderate (20 to 28), and severe depression (>= 29). Higher scores reflective of greater severity (worse outcome).|Baseline (Day -30 to -1), EOT visit (Week 24 for G2/3 and Week 48 for G1), and end of study (EOS) visit (Week 48 for G2/3 and Week 72 for G1).|Safety Population included all participants who received at least one dose of study treatment and have at least one post-baseline safety assessment (adverse event, laboratory/vital sign, physical examination; Beck Depression Inventory; Hepatitis Quality-of-Life Questionnaire). n = number of participants at indicated time points for each arm.||units on a scale||Standard Error|Mean
704120|NCT00087594|Secondary|Number of Participants With > =2 Log Drop From Baseline or Undetectable HCV-RNA (<10 IU/mL) at Week 12||Week 12|ITT Population included all enrolled participants who received at least one dose of study medication. n = number of participants at indicated time points for each arm.||participants|||Number
704121|NCT00087594|Secondary|Number of Participants With Biochemical Response Rate at Weeks 12, 24, and 48 (G1 Only) During Treatment and at 12 and 24 Weeks After Treatment Completion|Biochemical response is defined as the number of participants with a normal serum alanine aminotransferase (ALT) concentration (i.e., ALT < 30 U/L). EOT for G1 was Week 48 and for G2/3 was Week 24.|Weeks 12, 24, and 48 for G1 and Weeks 12 and 24 for G2/3; 12 and 24 weeks after EOT for G1 (Weeks 60 and 72) and G2/3 (Weeks 36 and 48)|ITT Population included all enrolled participants who received at least one dose of study medication. n = number of participants at indicated time points for each arm.||participants|||Number
704122|NCT00087594|Secondary|Number of Participants With Virological Response Rate at Weeks 12, 24, and 48 (G1 Only) During Treatment and at 12 Weeks After Treatment Completion|Virological Response Rate is defined as the number of participants with undetectable HCV-RNA (< 10 IU/mL). Treatment completion (end of treatment [EOT]) for G1 was Week 48 and for G2 or 3 was Week 24.|Weeks 12, 24, and 48 for G1 and Weeks 12 and 24 for G2/3; 12 and 24 weeks after EOT for G1 (Weeks 60 and 72) and G2/3 (Weeks 36 and 48)|ITT Population included all enrolled participants who received at least one dose of study medication. n = number of participants at indicated time points for each arm.||participants|||Number
704123|NCT00087594|Secondary|Number of Participants With Sustained Virological Response (SVR) Rate at 24 Weeks Post Treatment (Week 48 for G2/3 and Week 72 for G1)|SVR is defined as the number of participants with undetectable HCV-RNA (< 10 international unit per milliliter [IU/mL]) at 24 weeks post treatment completion.|Week 48 for G2/3 and Week 72 for G1|ITT Population included all enrolled participants who received at least one dose of study medication. n = number of participants at indicated time points for each arm.||participants|||Number
704124|NCT00087594|Primary|Number of Participants With Treatment Completion Rate (TCR)|TCR is defined as the number of participants who completed the prescribed duration of the study treatment. TCR for G1 participants is defined as the number of participants who had a missing value or >= 2-log10 decrease in Hepatitis C virus-ribonucleic acid (HCV RNA) at Week 12 and completed 48 weeks of study treatment or had a < 2-log10 decrease from baseline at Week 12 and completed at least 12 weeks of study treatment. TCR for G2/ 3 participants is defined as the number of participants who completed 24 weeks of study treatment.|Up to 24 weeks for G2/3; up to 48 weeks for G1|Safety Population included all participants who received at least one dose of study treatment and have at least one post-baseline safety assessment (adverse event, laboratory/vital sign, physical examination; Beck Depression Inventory; Hepatitis Quality-of-Life Questionnaire). n = number of participants at indicated time points for each arm.||participants|||Number
704125|NCT00087607|Secondary|Weekly AUC for IFN Concentrations for Pegasys and PEG-Intron Estimated by Population Pharmacokinetic Modeling|The estimation of weekly AUC for IFN concentrations for Pegasys and PEG-Intron was planned through population pharmacokinetic modeling. A population pharmacokinetic method deals with modelling in a cohort which has many participants (usually more than 40). The estimation of weekly AUC for IFN concentrations for Pegasys and PEG-Intron was planned to be studied in the population rather than the individuals in Peginterferon alfa-2a + Ribavirin and Peginterferon alfa-2b + Ribavirin groups.|Up to Week 8|The ITT Population included all participants who were randomized and received at least one dose of study medication (PEG-IFN or ribavirin). This outcome measure was not analyzed as no data were collected for any of the participants in this study.|||||
704126|NCT00087607|Secondary|Percentage of Participants With Each of the Identified HCV Quasispecies at Baseline and Weeks 1, 4, 8, and 12|The determination of evolution of HCV quasispecies in participants was planned through analyzing viral sequences in serum samples drawn at baseline and at Weeks 1, 4, 8, and 12 if HCV RNA tests were positive and if the levels were sufficient to do the analysis.|Baseline, Weeks 1, 4,8, and 12|The ITT Population included all participants who were randomized and received at least one dose of study medication (PEG-IFN or ribavirin). This outcome measure was not analyzed as no data were collected for any of the participants in this study.|||||
704134|NCT00087607|Secondary|Percentage of Participants With a ≥ 2-log10 Decrease or Undetectable (< 60 International Units Per Milliliter) HCV RNA at Each Visit|The virological response was determined as the proportion/percentage of participants with a ≥ 2-log10 decrease or undetectable HCV RNA at each week. Detection of >= 2-log10 decrease of <60 IU/mL HCV-RNA was done by amplicor PCR assay at each week. Detection of >=2-log10 decrease or undetectable HCV RNA at Week 12 was considered an early virological response (EVR).|From Week 1 to Week 12|The analysis population was ITT Population. The ITT Population included all participants who were randomized and received at least one dose of study medication (PEG-IFN or ribavirin).||percentage of participants||95% Confidence Interval|Number
704127|NCT00087607|Secondary|Number of Participants With Adverse Events and Serious Adverse Events|An adverse event (AE) was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Number of participants with at least one AE and SAE were reported.|Up to Week 12|The analysis population was the Safety Population. The Safety Population included all participants who were randomized, received at least one dose of study medication (PEG-IFN or ribavirin), and had at least one post-baseline safety assessment (defined as clinical adverse event, laboratory or vital sign data, or physical examination finding).||participants|||Number
704128|NCT00087607|Secondary|Area Under the Curve for Interferon in the Frequent-Sampling Cohort|Area Under the Curve (AUC) for Interferon (IFN) for Week 1 and Week 8 in the frequent-sampling cohort were calculated using the trapezoidal rule.|Week 1 and Week 8|The analysis population was ITT Population. The ITT Population included all participants who were randomized and received at least one dose of study medication (PEG-IFN or ribavirin). The “n” represents the number of participants assessed for AUC for Interferon for specified time point.||week*pg/mL||Standard Deviation|Mean
704129|NCT00087607|Secondary|Mean Trough Interferon Concentrations at Each Week|The weekly Interferon (IFN) concentrations were calculated using the trapezoid rule. The trough IFN concentration was analyzed using an enzyme-linked immunosorbent assay (ELISA), with limits of quantification of 250 picograms per milliliter [pg/mL] for Pegasys and 150 pg/mL for PEG-Intron respectively.|From Week 1 to Week 12|The analysis population was ITT Population. The ITT Population included all participants who were randomized and received at least one dose of study medication (PEG-IFN or ribavirin). The “n” represents the number of participants analyzed at a specified time point.||pg/mL||Standard Error|Mean
704130|NCT00087607|Secondary|Number of Participants With Marked Abnormalities in Thyroid Function Tests|Values outside the marked reference ranges for thyroid function test parameters that represent a defined, clinically relevant change from baseline are considered marked thyroid function test abnormalities. Roche’s standard reference ranges for thyroid function test parameters were used for the analysis. The thyroid function parameters with marked abnormalities were triiodothyronine (T3) (RR is 1.20 - 3.00 nanomole/liter [nmol/L]), thyroxine (T4) (RR is 51 – 154 nmol/L) and thyroid stimulating hormone (TSH) (RR is 0.0 - 5.0 milliunits per liter [mU/L]). Summary data of number of participants with only marked abnormalities in thyroid function tests are presented.|Baseline, up to Week 12|The analysis population was the Safety Population. The Safety Population included all participants who were randomized, received at least one dose of study medication (PEG-IFN or ribavirin), and had at least one post-baseline safety assessment (defined as clinical adverse event, laboratory or vital sign data, or physical examination finding).||participants|||Number
704131|NCT00087607|Secondary|Number of Participants With Marked Biochemical Test Abnormalities|Values outside the marked RR for biochemical test parameters that represent a defined, clinically relevant change from baseline are considered marked biochemical test abnormalities. Roche’s standard RR for biochemical parameters were used for this analysis. The biochemical test parameters with marked abnormalities were alanine aminotransferase (ALAT) (RR is 0 – 30 units per liter [U/L]), aspartate aminotransferase (ASAT) (RR is 0 – 25 U/L), gamma-glutamyl transferase (GGT) (RR is 0 – 60 U/L), total bilirubin (RR is 0 – 17 micromole/liter [umol/L]), creatinine (RR is 0 – 133 umol/L), total protein (RR is 60 – 80 g/L), triglycerides (RR is 0.45 - 1.70 millimole/liter [mmol/L]), chloride (RR is 100 – 108 mmol/L), potassium (RR is 3.5 - 5.0 mmol/L), sodium (RR is 133 – 145 mmol/L), calcium (RR is 2.10 - 2.60 mmol/L), random glucose (RR is 3.89 - 7.83 mmol/L), uric acid (140 – 500 umol/L). Summary data of number of participants with only marked biochemical test abnormalities are presented.|Baseline, up to Week 12|The analysis population was the Safety Population. The Safety Population included all participants who were randomized, received at least one dose of study medication (PEG-IFN or ribavirin), and had at least one post-baseline safety assessment (defined as clinical adverse event, laboratory or vital sign data, or physical examination finding).||participants|||Number
704132|NCT00087607|Secondary|Number of Participants With Marked Hematologic Abnormalities|The values outside the marked reference range for any hematology parameter that represents a defined, clinically relevant change from baseline are considered marked hematology abnormalities. The Roche standard reference ranges for the hematology parameters for which subjects had marked abnormalities were hematocrit [(RR) is 0.42 - 0.52 (fraction)], hemoglobin (RR is 13.0 - 18.0 gram/deciliter), platelets (RR is 150 – 450 10^9 cells/L), white blood cells (WBC) (RR is 4.3 - 10.8 10^9 cells/L), basophils (RR is 0.00 - 0.15 10^9 cells/L), lymphocytes (RR is 1.50 - 4.00 10^9 cells/L), monocytes (RR is 0.20 - 0.95 10^9 cells/L), neutrophils (RR is 1.83 - 7.25 10^9 cells/L), prothrombin time (PT) (RR is 9 – 13 seconds), partial thromboplastin time (Partial Throm.) (Time) (RR is 25.0 - 38.0 seconds) and PT International normalized ratio (INR) [RR is 0.70 - 1.30 (ratio)]. Summary data of number of participants with only marked hematology abnormalities are presented.|Baseline, up to Week 12|The analysis population was the Safety Population. The Safety Population included all participants who were randomized, received at least one dose of study medication (PEG-IFN or ribavirin), and had at least one post-baseline safety assessment (defined as clinical adverse event, laboratory or vital sign data, or physical examination finding).||participants|||Number
704133|NCT00087607|Secondary|Percentage of Participants With Undetectable HCV RNA (< 60 International Units/Milliliter) at Each Visit|The viral load was determined quantitatively and qualitatively by HCV-polymerase chain reaction (PCR). Qualitative viral titers will be assessed by Roche amplicor HCV Monitor® test v2.0 (< 600 IU/mL). The virological response was determined as the percentage of participants with undetectable HCV RNA at each week. A <60 IU/mL HCV-RNA was measured by amplicor PCR assay.|From Week 1 to Week 12|The analysis population was ITT Population. The ITT Population included all participants who were randomized and received at least one dose of study medication (PEG-IFN or ribavirin).||percentage of participants||95% Confidence Interval|Number
704229|NCT00098059|Primary|Time of Maximum Observed Plasma Concentration of Penciclovir (Tmax)|PK parameter; penciclovir is the active metabolite of famciclovir.|Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose|Includes all 27 patients enrolled in Part A of the study.||hours||Full Range|Median
704135|NCT00087607|Secondary|Weekly Viral Absolute Area Under the HCV RNA Curve Estimated in the Frequent-sampling Cohort for Weeks 1 and 8|The area under the HCV-RNA curve (HCV AUC) was defined as the area under the polygonal line defined by the HCV RNA values from the beginning of the window to the end of the window. For the frequent-sampling cohort, HCV AUCs over 7 days were calculated for Weeks 1 and 8, with intervals calculated beginning at the dose after which the frequent sampling began (different from the 7-day calendar period used for other AUC calculations). The AUCs for Weeks 1 and 8 in the frequent-sampling cohort (Sparse samples [SS] and frequent samples [FS]) were calculated using the trapezoidal rule.|Week 1 and Week 8|The analysis population was ITT Population. The ITT Population included all participants who were randomized and received at least one dose of study medication (PEG-IFN or ribavirin). The “n” represents the number of participants analyzed at a specified time point.||log (IU*week/mL)||Standard Deviation|Mean
704136|NCT00087607|Secondary|Cumulative Viral Absolute Area Under the HCV RNA Curve Minus Baseline Averaged Over the 12-week Period|The area under the HCV-RNA curve (HCV AUC) was calculated for each week as the area under the polygonal line defined by the HCV RNA values from the beginning of the window to the end of the window. Each of these areas was a sum of one or more trapezoids determined from the concentrations over the 7-day interval. The weekly AUCMB was calculated by subtracting the Week −1 HCV AUC (i.e., baseline) from the weekly HCV AUC. The HCV AUCMB to Week 12 was the sum of the 12 weekly HCV AUCMBs divided by the time (12 weeks).|Up to Week 12|The analysis population was ITT Population. The ITT Population included all participants who were randomized and received at least one dose of study medication (PEG-IFN or ribavirin).||log10 IU/mL||Standard Deviation|Mean
704137|NCT00087607|Secondary|Mean Value of Area Under the HCV-RNA Curve Minus Baseline From Week 1 to Week 12|The HCV AUC was calculated for each week as the area under the polygonal line defined by the HCV RNA values from the beginning of the time window to the end of the time window. Each of these areas was a sum of one or more trapezoids determined from the concentrations over the 7-day interval. The weekly AUCMB was calculated by subtracting the Week −1 HCV AUC (i.e., baseline) from the weekly HCV AUC and presented.|Baseline, Week 1 to Week 12|The analysis population was ITT Population. The ITT Population included all participants who were randomized and received at least one dose of study medication (PEG-IFN or ribavirin). The “n” represents the number of participants analyzed at a specified time point.||log (IU*week/mL)||Standard Deviation|Mean
704138|NCT00087607|Secondary|The Area Under the HCV-RNA Curve Estimated From the Two Adjacent Pre-dose Assessments at Each Week|The area under the HCV-RNA curve (HCV AUC) was defined as the area under the polygonal line defined by the HCV RNA values from the beginning of the time window to the end of the time window. Each of these areas was a sum of one or more trapezoids determined from the concentrations over the 7-day interval. The HCV AUC to Week 12 was the sum of the 12 weekly HCV AUCs divided by the time (12 weeks). Summary of weekly HCV AUC values estimated from the two adjacent pre-dose assessments are presented.|From Week -1 to Week 12|The analysis population was ITT Population. The ITT Population included all participants who were randomized and received at least one dose of study medication (PEG-IFN or ribavirin). The “n” represents the number of participants analyzed at a specified time point.||log 10 IU/mL||Standard Deviation|Mean
704139|NCT00087607|Secondary|Weekly Viral Load Assessed at Drug Trough|The viral load was determined quantitatively and qualitatively by HCV-PCR. HCV RNA was measured qualitatively using the Roche amplicor PCR assay (lower limit of detection 60 IU/mL, changed from 50 IU/mL with amendment B) and quantitatively using the Roche amplicor HCV monitor® test v2.0 (lower limit of quantification 600 IU/mL). Log transformations were performed for HCV RNA, and the analyses were done on a log10 scale. The viral load levels in the serum at baseline and for each week, were expressed in terms of a logarithmic scale with base 10, and averaged for all participants.|Baseline, up to Week 12|The analysis population was ITT Population. The ITT Population included all participants who were randomized and received at least one dose of study medication (PEG-IFN or ribavirin). The “n” represents the number of participants analyzed at a specified time point.||log (IU/mL)||Standard Deviation|Mean
704140|NCT00087607|Secondary|Mean Change From Baseline in Viral Load (log10 Reduction) at Week 4 and Week 8|The viral load was determined quantitatively and qualitatively by HCV-PCR. HCV RNA was measured qualitatively using the Roche amplicor PCR assay (lower limit of detection 60 IU/mL, changed from 50 IU/mL with amendment B) and quantitatively using the Roche amplicor HCV monitor® test v2.0 (lower limit of quantification 600 IU/mL). Log transformations were performed for HCV RNA, and the analyses were done on a log10 scale. The average value of the difference between viral load levels in the serum from baseline to week 4 and week 8, expressed in terms of a logarithmic scale with base 10 are presented.|Baseline, Week 4 and Week 8|The analysis population was ITT Population. The ITT Population included all participants who were randomized and received at least one dose of study medication (PEG-IFN or ribavirin).The “n” represents the number of participants analyzed at a specified time point.||log (IU/mL)||Standard Error|Mean
704141|NCT00087607|Primary|Change From Baseline in Viral Load (log10 Reduction) at Week 12|The viral load was determined quantitatively and qualitatively by Hepatitis C virus (HCV)-polymerase chain reaction (PCR). HCV RNA was measured qualitatively using the Roche amplicor PCR assay (lower limit of detection 60 international units per milliliter (U/mL), changed from 50 IU/mL with amendment B) and quantitatively using the Roche amplicor HCV monitor® test v2.0 (lower limit of quantification 600 IU/mL). Log transformations were performed for HCV RNA, and the analyses were done on a log10 scale. The average value of the difference between viral load levels in the serum from baseline to Week 12, expressed in terms of a logarithmic scale with base 10, are presented.|From Baseline to Week 12|The analysis population was ITT Population. The ITT Population included all participants who were randomized and received at least one dose of study medication (PEG-IFN or ribavirin). Data using ITT Population are presented below.||log (IU/mL)||Standard Error|Mean
704142|NCT00087633|Secondary|Summary of Virologic Response|Rapid virologic responder (RVR): undetectable HCV-RNA at Week 4; complete early virologic responder (cEVR): undetectable HCV-RNA at Week 12; partial early virologic responder (pEVR): ≥2 log10 drop from baseline in HCV-RNA but positive at Week 12; early virologic responder (EVR): undetectable HCV-RNA or ≥2 log10 drop from baseline in HCV-RNA at Week 12; 24 weeks negative: undetectable HCV-RNA at Week 24; 48 weeks negative: undetectable HCV-RNA at Week 48; sustained virologic response (SVR): undetectable HCV-RNA at 24 weeks after the end of treatment.|After 4, 12, 24 and 48 weeks of therapy, and 24 weeks of follow-up|ITT population||participants|||Number
704378|NCT00099021|Secondary|Ki 67 Labeling Index|Immune histochemistry / tissue staining for a possible biomarker.|Pre (Day 0) and Post (Week 12) Treatment||||||
704143|NCT00087633|Primary|Percentage of Patients With Histologically-confirmed Recurrence of Hepatitis C Virus (HCV)|"Histologically-confirmed recurrence of HCV defined as Batts-Ludwig inflammation grade ≥3 and/or fibrosis stage ≥2.
Inflammation(Grade): 0 No Activity,1 Minimal,2 Mild,3 Moderate,4 Severe.
Fibrosis (Stage): 0 No fibrosis, Normal; 1 Portal fibrosis; 2 Periportal fibrosis or rare portal septa; 3 Septal fibrosis, Fibrous septa with architectural distortion, no obvious cirrhosis; 4 Cirrhosis."|120 weeks postrandomization|Intent-to-treat population||percentage of participants|||Number
704144|NCT00087646|Secondary|Percentage of Participants With Relapse After End of Treatment|The percentage of participants who relapsed (loss of response) after having achieved a virological response at the end of treatment was determined.|Week 96 (Group A and C) and Week 72 (Group B and D)|ITT population included all participants randomized who received at least one dose of study medication.||percentage of participants|||Number
704145|NCT00087646|Secondary|Percentage of Participants With Maintenance of Actual End-of-Treatment Virological Response|Maintenance of end-of-treatment virological response was assessed based on all participants treated and according to the actual treatment period (backward imputation method). The percentage of participants who maintained their end-of-treatment virological response was determined. Maintenance of actual end-of-treatment virological response was calculated by dividing the number of participants with a virological response both at the end of the actual untreated follow-up period and at the end of the actual treatment period by the number of participants with a virological response at the actual end of treatment.|Week 96 (Group A and C) and Week 72 (Group B and D)|ITT population included all participants randomized who received at least one dose of study medication.||percentage of participants|||Number
704146|NCT00087646|Secondary|Change From Baseline in Reduction of HCV Viremia (Groups A + B vs Groups C + D)|The mean change from baseline in HCV RNA level (reduction in viral load) at Week 12 and 24 were determined. HCV RNA result were not detectable (<50 IU/ML) and not quantifiable (<600 IU/ML). Baseline value were assessed on Day 1 before the administration of the first dose of study drug.|At Week 12 and 24|ITT population included all participants randomized who received at least one dose of study medication.||IU/ML||95% Confidence Interval|Mean
704147|NCT00087646|Secondary|Percentage of Participants With >=2log Drop in HCV-RNA|Reduction in HCV-RNA titers of at least 2 log10 after 12/24 weeks of study treatment (i.e. 99% reduction of viral load) was analyzed. Percentage of participants with at least a 2 log10 drop of HCV-RNA at study week 12 and 24 (lower limit of quantitation 600 IU/mL) as compared to baseline or non-detectable HCV-RNA (lower limit of detection 50 IU/mL) were reported.|At Week 12 and 24|ITT population included all the participants randomized who received at least one dose of study medication.||percentage of participants|||Number
704148|NCT00087646|Secondary|Percentage of Participants With Undetectable HCV-RNA|"The percentage of participants with a undetectable HCV RNA 24 weeks after the end of the treatment period (defined as a single last HCV RNA < 50 IU/mL measured >= 20 weeks after treatment end, ie, >=140 days after treatment end) are reported.
End-of-treatment (EOT) virological response is defined as last HCV RNA measurement that is not detectable (<50 IU/mL) at study day of last dose of study medication (+/- 28 days)."|At Week 12, 24, 48 and EOT|ITT population included all participants randomized who received at least one dose of study medication.||percentage of participants|||Number
704149|NCT00087646|Secondary|Number of Participants With Sustained Virological Response (Groups A + C vs Groups B + D)|SVR was defined as the percentage of participants with a undetectable hepatitis C virus- ribonucleic acid (HCV RNA) 24 weeks after the end of the treatment period (defined as a single last HCV RNA < 50 International Units Per Millilitre (IU/mL) measured >= 20 weeks after treatment end, ie, >=140 days after treatment end.|At Week 48 and Week 72|ITT population included all participants randomized who received at least one dose of study medication.||participants|||Number
704150|NCT00087646|Secondary|Number of Participants With Sustained Virological Response (Groups A + B vs Groups C + D)|SVR was defined as the percentage of participants with a undetectable hepatitis C virus- ribonucleic acid (HCV RNA) 24 weeks after the end of the treatment period (defined as a single last HCV RNA < 50 International Units Per Millilitre (IU/mL) measured >= 20 weeks after treatment end, ie, >=140 days after treatment end.|At Week 48 and Week 72|ITT population included all participants randomized who received at least one dose of study medication.||participants|||Number
704151|NCT00087646|Primary|Number of Participants With Sustained Virological Response Rate|Sustained Virological Response (SVR) was defined as the percentage of participants with a undetectable hepatitis C virus- ribonucleic acid (HCV RNA) 24 weeks after the end of the treatment period (defined as a single last HCV RNA < 50 International Units Per Millilitre (IU/mL) measured >= 20 weeks after treatment end, ie, >=140 days after treatment end.|Up to 72 weeks (Group A) and 48 weeks (Group D)|Intent-to-treat analysis population (ITT) included, all participants randomized who received at least one dose of study medication.||participants|||Number
704152|NCT00087672|Primary|Efficacy of CC-5013 in Myelofibrosis|"Response evaluation, sustained for 2 weeks: Complete Remission (Neutrophil count between 1 to 10 x 10^9/L without peripheral blasts in blood or bone marrow); Partial Hematologic Response/Partial Remission (Increase in neutrophil by 50% + above 10^9/L for neutropenia); Hematologic Improvement (increase in Neutrophil count, hemoglobin, platelet count or reduction in blood/marrow blasts) or No Response.
If nine or < patients respond to therapy (response other than 'No Response'), therapy declared ineffective. However, if 11 or > patients respond to therapy, therapy considered efficacious."|3 - 4 Months for all patients; 24 months for responders|Intention to treat: After a total of 41 patients were enrolled in study, nine or more patients responded to the therapy, therapy declared effective.||Participants|||Number
704153|NCT00087685|Primary|Clinical Benefit Rate|Clinical benefit rate (CBR) is defined as the objective response rate plus the proportion of participants with prolonged stable disease (SD), e.g. nonprogression at 20 weeks. Objective response rate (ORR), determined by tumor assessments from radiological tests or physical examination using Response Evaluation Criteria In Solid Tumors (RECIST).|20 weeks|Of the 35 participants, four (4) were inevaluable due to inadequate treatment on trial.||percentage of participants||95% Confidence Interval|Number
704187|NCT00097500|Secondary|Beta-cell Function 4 Weeks After Cessation of Therapy|Treatment effect on beta-cell function as measured by the ratio of Week 56 arginine-stimulated insulin secretion during a hyperglycemic clamp(specifically, the incremental AUC of insulin with respect to basal value over a 10 min period [i.e., clamp time 290 min to 300 min]) to that at baseline (i.e., the ratio is calculated as arginine-stimulated insulin secretion at week 56 divided by arginine-stimulated insulin secretion at baseline [week -2]).|Baseline (week -2) and 56 weeks|Evaluable population||ratio||Standard Error|Least Squares Mean
704154|NCT00087685|Primary|Number of Participants With Objective Response Plus Stable Disease Rate (CR + PR + SD)|Response determined by tumor assessments from radiological tests or physical examination using Response Evaluation Criteria In Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial Response (PR): At least 30% decrease in sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. Stable Disease (SD): Any condition not meeting the above criteria. The minimum duration for the SD will be 8 weeks. If the participant has stable disease at the time of the first radiographic evaluation, he/she will be considered to have stable disease. Progressive Disease (PD): At least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.|8 weeks|Of the 35 participants, four (4) were inevaluable due to inadequate treatment on trial.||participants|||Number
704155|NCT00087698|Secondary|Overall Survival Time|Number of months between the first dose date and the date of death as a result of any cause. Overall survival time calculated as (Date of death - First dose date + 1)/(365.25/12).|baseline to date of death from any cause|All participants who had undergone surgery.||months||Full Range|Mean
704156|NCT00087698|Secondary|Time to Progressive Disease|Number of months between the first dose date and the date of first disease progression or death as a result of any cause, whichever comes first.|baseline to measured progressive disease|All participants who had undergone surgery.||months||Full Range|Mean
704157|NCT00087698|Secondary|Time to Treatment Failure|Time to relapse (treatment failure) is measured in months and calculated as (Date of first surgery - Date of first relapse after surgery + 1)/(365.25/12). Time to relapse will be censored at the date of the last visit or start date of further anti-tumor therapy or intervention, whichever comes first.|baseline to stopping treatment|All participants who had undergone surgery.||months||Full Range|Mean
704158|NCT00087698|Secondary|Overall Tumor Response|The frequency of best overall tumor response summarized by response category. The best (unconfirmed) response recorded from the start of chemotherapy treatment until disease progression/recurrence, start of any further anti-tumor therapy, or time of surgery whichever comes first.|baseline to measured progressive disease|Intention to Treat analysis. All enrolled participants who were eligible for the treatment, whether or not they received the study drug.||participants|||Number
704159|NCT00087698|Secondary|The 1 and 2 Year Disease-Free Survival Rate (Percentage)|Kaplan-Meier estimates of the percentage of participants still alive at 1-year and 2-years, based upon the total number of participants who had surgery.|1 year and 2 years|All participants who had undergone surgery.||percentage of participants||95% Confidence Interval|Mean
704160|NCT00087698|Primary|Pathological Complete Response|"Number of participants with results of pathological review that indicated a complete response. Pathological complete response should be evaluated at the time of surgery (Extrapleural Pneumonectomy [EPP]).
Resected tissue or pleural fluid should be sent for pathological and histological evaluation."|Surgery (at least 3 weeks post last dose of chemotherapy, up to a maximum interval of 8 weeks)|All participants who had undergone surgery.||participants|||Number
704161|NCT00097253|Primary|Immune Function: Delayed Hypersensitivity to Candida(DTH)|DTH memory responses to a common infectious agent provided a measure of T-cell immunity. Nurses inoculated subject's arm with 0.1ml Candida (stock solution diluted 1:20 in saline, Greer Labs, NC) intradermally, after the cold pressor stressor. The wheal diameter (2 dimensions) was self-assessed at 24, 48, and 72 hours by participants given detailed instructions and templates for measurement.|Day 1 11:45, Day 2 (24h) 11:45, Day 3 (48h) 11:45, Day 4 (72h) 11:45.|||mm^2||Standard Deviation|Mean
704162|NCT00097253|Primary|Skin Barrier Repair|TEWL (Transepidermal Water Loss, via tape stripping procedure)measured before and after cold pressor stressor (11:00). After obtaining baseline measurements on volar forearm, cellophane tape(3M Scotch-type; St. Paul, MN) was applied repeatedly (6–50 times) to remove superficial layer of cornified skin cells. Tape stripping stopped when TEWL was elevated from the basal level of 5–7 g/h/m2 to at least 20 g/h/m2. The number of strips required to reach TEWL X20 g/m2/h was the measure of barrier. TEWL was measured with a computerized evaporimetry instrument, the DermaLabs (CyberDERM, Media, PA).|3 Visits with at least 2 weeks between each. Average time to complete all visits was 64.46 days (SD 48.4).10:05, 11:45, 13:15|||number tape strips||Standard Deviation|Mean
704163|NCT00097253|Primary|Immune Function|Stimulated Cytokine Production (Interleukin-6 (IL-6), Interleukin-10 (IL-10)) measured before and after cold pressor stressor, which occurred at 11:00.|3 Visits with at least 2 weeks between each. Average time to complete all visits was 64.46 days (SD 48.4). 9:05, 10:05, 11:45|||pg/ml||Standard Deviation|Mean
704164|NCT00097253|Primary|Cortisol and Catecholamine Production|Cortisol, norepinephrine, epinephrine measured before and after physical (cold pressor) stressor, which occurred at 11:00.|3 Visits with at least 2 weeks between each. Average time to complete all visits was 64.46 days (SD 48.4). Cortisol: 9:05, 10:05, 10:55, 11:45, 12:15, 13:00. Nor/Epi: 9:05, 10:05, 10:55, 11:05, 11:45, 12:15|||pg/ml (log 10)||Standard Deviation|Mean
704165|NCT00097370|Secondary|Change From Baseline in QoL and Current Health Status: Mental Summary Score of the SF12 3 Months After the Start of Study MHE100901 and Every 6 Months Thereafter|The SF-12v2 is the 12 item abbreviated form of SF-36v2 survey developed by the Medical Outcomes Trust and QualityMetric Incorporated. It provides information about how participants feel, and how well they have been able to perform their usual activities, over the past 4 weeks. SF-12v2 scale questions make up 8 scales: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, Mental Health are for mental component summary. Transformed mental component summary score (MCS-12) is derived using all the 12 items and scored onto a 0-100 scale such that a higher score indicates a better health state and better functioning. Change from Baseline in scale or summary measure score is the difference between the score at the time point being analyzed to Baseline.|Baseline and up to approximately 6 years|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).||Scores on a scale||Standard Deviation|Mean
704210|NCT00097773|Secondary|Proportion of Participants With a Pa Positive Culture|"Proportion of participants with a Pa positive culture compared between (1) the pooled cycled therapy group (n=152) and pooled culture-based therapy group (n=152), and (2) between the pooled oral placebo (n=152)and pooled cipro groups (n=152).
Participants are included once in the cycled and culture-based columns, and once in the oral cipro and placebo columns"|Week 10 (after initial treatment course for Pa) through Month 18|Intent to treat||Participants|||Number
704166|NCT00097370|Secondary|Change From Baseline in Quality of Life (QoL) and Current Health Status: Physical Summary Score of the Study Short Form Health Survey (SF-12) 3 Months After the Start of Study MHE100901 and Every 6 Months Thereafter|The SF-12v2 is the 12 item abbreviated form of SF-36v2 survey . It provides information about how participants feel, and how well they have been able to perform their usual activities, over the past 4 weeks. SF-12v2 questions make up 8 scales: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, Mental Health . Transformed physical component summary score (PCS-12) is derived using all the 12 items and scored onto a 0-100 scale such that a higher score indicates a better health state and better functioning. Change from Baseline in scale or summary measure score is the difference between the score at the time point being analyzed to Baseline.|Baseline and up to approximately 6 years|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).||Scores on the scale||Standard Deviation|Mean
704167|NCT00097370|Secondary|Change From Baseline in Erythema/Edema Score 3 Months After the Start of Study MHE100901 and Every 6 Months Thereafter|The erythema subscale score and edema subscale score are each graded on a 0-3 scale, with 0 = absent , 1 = mild, 2 = moderate, 3 = severe. The total score ranged from 0 to 6, with higher scores indicative of more severe Erythema/Edema. The total score was obtained by summing together the responses for each of the two subscale items. Change from Baseline in erythema/edema total score is the difference between erythema/edema total score at the time point being analyzed to the MHE100901 Baseline score..|Baseline and up to approximately 6 years|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).||Scores on a scale||Standard Deviation|Mean
704168|NCT00097370|Secondary|Change From Baseline in the Pruritus Visual Analogue Scale (pVAS) 3 Months After the Start of Study MHE100901 and Every 6 Months Thereafter|The pruritus visual analogue scale asks participants to rate the status of their Pruritus based on the severity of their itch. Scores range from 0-100 with 0 = No itch and 100 = Worst imaginable itch. Change from Baseline in pVAS score is the difference between the pVAS score at the time point being considered to the MHE100901 Baseline score.|Baseline and up to approximately 6 years|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).||Scores on the scale||Standard Deviation|Mean
704169|NCT00097370|Secondary|Number of Participants by Dosing Frequency Groups (Defined as Two Week Dosing Ranges Greater Than a 4 Week Interval) at the End of Stage 2|The number of participants at the end of Stage 2 with study medication dosing frequencies of 4 weeks, 5-6 weeks, 7-8 weeks, 9-10 weeks, 11-12 weeks, 13-16 weeks, 17-20 weeks, 21-24 weeks and >24 weeks were summarized. The first infusion date in Stage 3 and the last infusion date in Stage 2 were used to calculate the dosing frequency.|up to approximately 6 years|ITT Population. Only those participants available at end of Stage 2 were included.||Participants|||Number
704170|NCT00097370|Secondary|Blood Eosinophil Count (With Consideration of the HES Background Therapy) During Stages 1-3|Mean blood eosinophil counts were summarized over time taking into account the effect of HES background therapy. Eosinophil count observations for only those participants taking mepolizumab in conjunction with prednisone or as monotherapy were included.|up to approximately 6 years|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).||Cell/uL||Standard Deviation|Mean
704171|NCT00097370|Secondary|For Those Participants Who Entered Stage 1 From Study MHE100185 With >10 mg Prednisone: Number of Participants Achieving a Prednisone Dose <=10 mg (as Sole Background Therapy) for>=3 Months|Participants from study MHE100185 who completed the 9 months treatment period and achieved a level of >10 mg prednisone at the end of the study and participants who withdrew from the study early who were at a prednisone dose level >10 mg were analyzed. Duration of doses <= 10 mg was determined by examining changes in the prednisone dosing or allowable alternative corticosteroid medication (prednisone equivalents). Start and stop dates of other HES medications were checked to ensure that they do not overlap with the steroid dosing dates. If it did, then the number of days <=10 mg during this overlap was considered as zero and the cumulative days reset to zero, as the endpoint was assessing prednisone dose as sole background therapy. The dosing criteria for this endpoint was considered as achieved if the duration of dosing was minimum of 84 days (3months)|up to approximately 6 years|ITT Population. Only those participants who entered Stage 1 from study MHE100185 with >10 mg prednisone were analyzed.||Participants|||Number
704172|NCT00097370|Secondary|For Those Participants Who Entered Stage 2 From Study MHE100185 With a Prednisone Level of <=10 mg Prednisone: Number of Participants Achieving a Prednisone Dose <=10 mg (as Sole Background Therapy) for >=3 Months;|Participants from study MHE100185 who completed the 9 months treatment period and achieved a level of <=10 mg of prednisone at study end and participants who withdrew from the study early who were at a prednisone dose level <=10 mg were analyzed. Duration of doses <= 10 mg were determined by examining changes in the prednisone dosing or allowable alternative corticosteroid medication (prednisone equivalents). Start and stop dates of other HES medications were checked to ensure that they did not overlap with the steroid dosing dates. If overlap occurred, then the number of days <=10 mg during this overlap was considered as zero and the cumulative days reset to zero, as the endpoint was assessing prednisone dose as sole background therapy. The dosing criteria for this endpoint was considered as achieved if the duration of dosing was minimum of 84 days (3months).|up to approximately 6 years|ITT Population. Only those participants who entered Stage 2 from study MHE100185 with a prednisone level of <=10 mg prednisone were analyzed.||Participants|||Number
704173|NCT00097370|Secondary|For Those Participants Who Completed 9 Months of Dosing in Study MHE100185 and Achieved a Prednisone Level >10 mg: Number of Participants Achieving <=10 mg Prednisone (as Sole Background Therapy) for >= 8 Weeks|Participants from study MHE100185 who completed the 9 months treatment period and achieved a level of prednisone of >10 mg at the end of the study were analyzed. Duration of doses <= 10 mg were determined by examining changes in the prednisone dosing or allowable alternative corticosteroid medication (prednisone equivalents). Start and stop dates of other HES medications were checked to ensure that they did not overlap with the steroid dosing dates. If overap occurred, then the number of days <=10 mg during this overlap was considered as zero and the cumulative days reset to zero, as the endpoint was assessing prednisone dose as sole background therapy. The dosing criteria for this endpoint was considered as achieved if the duration of dosing was minimum of 53 days (8 weeks).|up to approximately 6 years|ITT Population. Only those participants who completed 9 months of dosing in study MHE100185 and achieved a prednisone level >10 mg were analyzed.||Participants|||Number
704174|NCT00097370|Secondary|For Those Participants Who Completed 9 Months of Dosing in Study MHE100185 and Achieved a Prednisone Level <=10 mg: Number of Participants Achieving <= 10 mg Prednisone (as Sole Background Therapy) for >= 3months|Participants from study MHE100185 who completed the 9 months treatment period and achieved a level of <=10 mg of prednisone at study end were analyzed. Duration of doses <=10 mg was determined by examining changes in the prednisone dosing or allowable alternative corticosteroid medication (prednisone equivalents). Start and stop dates of other HES medications were checked to ensure that they did not overlap with the steroid dosing dates. If it did, then the number of days <=10 mg during this overlap was considered as zero and the cumulative days reset to zero, as the endpoint was assessing prednisone dose as sole background therapy. The dosing criteria for this endpoint was considered as achieved if the duration of dosing was minimum of 84 days (3months).|up to approximately 6 years|ITT Population. Only those participants who completed 9 months of dosing in study MHE100185 and achieved a prednisone level <=10 mg were analyzed.||Participants|||Number
704175|NCT00097370|Secondary|Number of Participants Achieving an Eosinophil Level of < 600 Cell/Microliter (uL) (in Addition to the Lowest Background Therapy) at the End of Study|The criteria for eosinophil count was achieved if the participant's eosinophil count remained below <600 cell/uL for the last observation on study i.e. within length of dosing cycle + 7 days of last dose of study drug. For participants who entered in Stage 1, HES medications taking prior to the first infusion date in Stage 2 were considered as the lowest background therapy. For participants who entered in Stage 2, HES medications taken on the date that immediately preceded the first infusion date of study drug and had not been discontinued was regarded as the lowest background therapy. If the dose of the lowest background therapy had increased or the medication had changed or the participant had not reached their lowest background therapy, the participant was regarded as not achieving this endpoint.|up to approximately 6 years|ITT Population||Participants|||Number
704176|NCT00097370|Secondary|Number of Participants Achieving a Prednisone Level of =<10 mg (as Sole Background Therapy) at the End of Study|Participants who were receiving a prednisone dose level of =<10 mg as their sole background therapy at the end of the study were included for the analysis.|up to approximately 6 years|ITT Population||Participants|||Number
704177|NCT00097370|Primary|Number of Participants With Any Adverse Event (AE) During the Follow-up Phase|An AE is any untoward medical occurrence in clinical investigation participants temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs are summarized by Follow-up phase. Safety and tolerability of the study drug was assessed by number of participants with any AE|From end of Treatment Phase up to 97 days after the last dose date (up to approximately 6 years)|Follow-up Population: subset of the modified ITT Population who had evidence of being in the study > length of dosing cycle + 7 days after the date of their last dose of study medication and up to and including 97 days after their last dose date.||Participants|||Number
704178|NCT00097370|Primary|Number of Participants With Any Adverse Event (AE) During the Treatment Phase|An AE is any untoward medical occurrence in clinical investigation participants temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs are summarized by Treatment phase. Safety and tolerability of the study drug was assessed by number of participants with any AE|From the first dose of study medication up to 7 days after the last dose (up to approximately 6 years)|Intent-to-Treat (ITT) Population: all enrolled participants who received at least one dose of mepolizumab in this study.||Participants|||Number
704179|NCT00097448|Primary|Hearing Improvement|Change from baseline to 2mos of 4-frequency (500, 1000, 2000, 4000Hz) pure tone average.|2 months|Intention-to-treat||dB||Standard Deviation|Mean
704180|NCT00097500|Secondary|M-value at Baseline, Week 52 and Week 56|M-value at baseline (week -2), week 52 (end of on-drug period), and week 56 (during off-drug period). Insulin sensitivity was assessed during the euglycemic/hyperglycemic clamp test at baseline (week -2), week 52, and week 56. Insulin-mediated glucose uptake (M-value) was calculated as the mean glucose requirement during the 90-120 minute interval of the clamp.|baseline (week -2), 52 weeks, and 56 weeks|Evaluable population.||mg/min/kg||Standard Error|Mean
704181|NCT00097500|Secondary|Change in Body Weight|Change in body weight from week 0 to week 52 (i.e., body weight at week 52 minus body weight at week 0).|0 weeks and 52 weeks|Intent to treat population. Last observation carried forward.||kg||Standard Error|Least Squares Mean
704182|NCT00097500|Secondary|Seven Point Self Monitored Blood Glucose (SMBG) Measurements|SMBG measured at 7 time points (before and after breakfast, before and after lunch, before and after dinner, at bedtime).|0 weeks and 52 weeks|Intent to treat population.||mmol/L||Standard Deviation|Mean
704183|NCT00097500|Secondary|Change in Fasting Plasma Glucose|Change in fasting plasma glucose from week 0 to week 52 (i.e., fasting plasma glucose at week 52 minus fasting plasma glucose at week 0).|0 weeks and 52 weeks|Intent to treat population. Last observation carried forward.||mmol/L||Standard Error|Least Squares Mean
704184|NCT00097500|Secondary|Change in Glycosylated Hemoglobin (HbA1c)|Change in HbA1c from week 0 to week 52 (i.e., HbA1c at week 52 minus HbA1c at week 0).|Week 0 and week 52|Intent to treat population. Last observation carried forward.||percent||Standard Error|Least Squares Mean
704185|NCT00097500|Secondary|Change in Second Phase C-peptide Release|Ratio of second phase C-peptide response to glucose at 52 weeks (end of on-drug period) and 56 weeks (during off-drug period) compared to second phase C-peptide response to glucose at baseline (i.e., C-peptide response to glucose at week 52 or week 56 divided by C-peptide response to glucose at baseline [week -2]). C-peptide is measured as a surrogate marker of insulin secretion. Second phase C-peptide/insulin release is measured from time=10 minutes to time=80 minutes of glucose infusion during a hyperglycemic clamp procedure.|baseline (-2 weeks), 52 weeks, and 56 weeks|Evaluable population. Last observation carried forward.||ratio||Standard Error|Least Squares Mean
704186|NCT00097500|Secondary|Change in First Phase C-peptide Release|Ratio of first phase C-peptide response to glucose at 52 weeks (end of on-drug period) and 56 weeks (during off-drug period) compared to first phase C-peptide response to glucose at baseline (i.e., C-peptide response to glucose at week 52 or week 56 divided by C-peptide response to glucose at baseline [week -2]). C-peptide is measured as a surrogate marker of insulin secretion. First phase C-peptide/insulin release is measured during the first ten minutes of glucose infusion during a hyperglycemic clamp procedure.|baseline (week -2), 52 weeks, and 56 weeks|Evaluable population. Last observation carried forward.||ratio||Standard Error|Least Squares Mean
704379|NCT00099021|Secondary|Nf Kappa B p65|Immune histochemistry / tissue staining for a possible biomarker.|Pre (Day 0) and Post (Week 12) Treatment||||||
704188|NCT00097500|Primary|Beta-cell Function After 52 Weeks of Therapy|Treatment effect on beta-cell function as measured by the ratio of Week 52 arginine-stimulated insulin secretion during a hyperglycemic clamp(specifically, the incremental AUC of insulin with respect to basal value over a 10 min period [i.e., clamp time 290 min to 300 min]) to that at baseline (i.e., the ratio is calculated as arginine-stimulated insulin secretion at week 52 divided by arginine-stimulated insulin secretion at baseline [week -2]).|Baseline (week -2) and 52 weeks|Evaluable population||ratio||Standard Error|Least Squares Mean
704189|NCT00097539|Primary|Near Adult Height (NAH)|Heights were standardized with height standardized deviation scores (SDS) to enable height comparisons across ages and sexes using methods and height standards found at: http://www.cdc.gov/growthcharts/cdc_charts.htm. NAH were calculated overall and by etiology groups for participants who had both a non-missing value available height z-score and a non-missing enrollment height (EH) SDS, as well as for participants with 3 or more years of GH therapy (GHT ≥3y).|From October 1985 to June 2010 (overall approximately 24 years and 9 months)|Safety evaluable population. Here, 'N' (number of participants analyzed) signifies the number of participants evaluable for this outcome measure and 'Number Analyzed' signifies the number of participants evaluable for specified category.||SDS||Standard Deviation|Mean
704190|NCT00097539|Primary|Third Year Annualized Growth Rate|Annualized growth rates are expressed as cm/yr, computed as the change in height (centimeters) divided by the change in age (years). Growth rates were calculated from the date of the visit closest to 730 days after baseline to the visit closest to 1095 days. Visits within 90 days of 730 and 1095 days after baseline may be used. If multiple visits within 90 days were reported then the visit closest to 730 or 1095 days was used. Growth rates <-1 or >30 cm/yr were excluded. Growth rates from -1 to 0 were set to 0 cm/yr. Growth rates are summarized by etiology group and gender. Only those participants who had non-missing third-year growth rate data were included in the analysis.|Year 3|Safety evaluable population. Here, 'N' (number of participants analyzed) signifies the number of participants evaluable for this outcome measure and 'Number Analyzed' signifies the number of participants evaluable for specified category.||cm/yr||Standard Deviation|Mean
704191|NCT00097539|Primary|Second Year Annualized Growth Rate|Annualized growth rates are expressed as cm/yr, computed as the change in height (centimeters) divided by the change in age (years). Growth rates were calculated from the date of the visit closest to 365 days after baseline to the visit closest to 730 days. Visits within 90 days of 365 and 730 days after baseline may be used. If multiple visits within 90 days were reported then the visit closest to 365 or 730 days was used. Growth rates <-1 or >30 cm/yr were excluded. Growth rates from -1 to 0 were set to 0 cm/yr. Growth rates are summarized by etiology group and gender. Only those participants who had non-missing second-year growth rate data were included in the analysis.|Year 2|Safety evaluable population. Here, 'N' (number of participants analyzed) signifies the number of participants evaluable for this outcome measure and 'Number Analyzed' signifies the number of participants evaluable for specified category.||cm/yr||Standard Deviation|Mean
704192|NCT00097539|Primary|First Year Annualized Growth Rate|Annualized growth rates are expressed as centimeters per year (cm/yr), computed as the change in height (centimeters) divided by the change in age (years). Growth rates were calculated from the date of the first injection (baseline/ enrollment) to the visit closest to 365*1 days after baseline. Visits within 90 days of 365*1 days after baseline may be used. If multiple visits within 90 days were reported then the visit closest to 365*1 days was used. Growth rates less than (<) -1 or greater than (>) 30 cm/yr were excluded. Growth rates from -1 to 0 were set to 0 cm/yr. Growth rates are summarized by etiology group and gender. Only those participants who had non-missing 1-year growth rate data were included in the analysis.|Year 1|Safety evaluable population. Here, 'N' (number of participants analyzed) signifies the number of participants evaluable for this outcome measure and 'Number Analyzed' signifies the number of participants evaluable for specified category.||cm/yr||Standard Deviation|Mean
704193|NCT00097539|Primary|Number of Participants Who Died||From October 1985 to June 2010 (overall approximately 24 years and 9 months)|Safety evaluable population||participants|||Number
704194|NCT00097591|Secondary|Number of Subjects Reaching the Composite Endpoint of All-Cause Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke|The endpoint in this measure is a combination of all-cause death, nonfatal MI, or nonfatal stroke. Results are reported for the All ACS population.|Randomization up to 15 months|Intention-to-treat (ITT) population consisting of all randomized All ACS subjects who may or may not have received study drug.||Participants|||Number
704195|NCT00097591|Secondary|Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, or Rehospitalization for Cardiac Ischemic Events|The endpoint in this measure is a combination of CV death, nonfatal MI, nonfatal stroke, or rehospitalization for cardiac ischemic events. Results are reported for the All ACS population.|Randomization up to 15 months|Intention-to-treat (ITT) population consisting of all randomized All ACS subjects who may or may not have received study drug.||Participants|||Number
704196|NCT00097591|Secondary|Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke|The endpoint in this measure is a combination of CV death, nonfatal MI, or nonfatal stroke. Results are reported for the All ACS population for the 30 and 90 day periods.|Randomization to 30 days; randomization to 90 days|Intention-to-treat (ITT) population consisting of all randomized All ACS subjects who may or may not have received study drug.||Participants|||Number
704197|NCT00097591|Secondary|Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Urgent Target Vessel Revascularization (UTVR)|The endpoint in this measure is a combination of CV death, nonfatal MI, or UTVR. Results are reported for the All ACS subject population for the 30 and 90 day periods.|Randomization to 30 days; randomization to 90 days|Intention-to-treat (ITT) population consisting of all randomized All ACS subjects who may or may not have received study drug.||Participants|||Number
704211|NCT00097773|Primary|Number of Participants With a Pulmonary Exacerbation Requiring IV Antibiotics or Hospitalization|"The primary comparison is between the pooled culture-based group and the pooled cycled group. A secondary comparison is between the pooled ciprofloxacin group vs the pooled placebo group. Descriptive results are provided for the pooled treatment groups.
Participants are represented once in the cycled and culture-based therapy columns, and once in the cipro and placebo columns."|Measured over the 18 month study|Intent to treat||number of participants|||Number
704198|NCT00097591|Secondary|Number of Treated Subjects With Non-Coronary Artery Bypass Graft (CABG) Related Thrombolysis In Myocardial Infarction (TIMI) Study Group Major and Minor Bleeding Events|TIMI classification for major and minor bleeding in the subset of subjects who did not undergo a coronary artery bypass operation (CABG) were defined as follows: Major bleeding: any intracranial hemorrhage (ICH) OR any clinically overt bleeding (including bleeding evident on imaging studies) associated with a fall in hemoglobin (Hgb) of ≥5 grams/deciliter (gm/dL)from baseline. Minor Bleeding: any clinically overt bleeding associated with a fall in Hgb of ≥3 gm/dL but <5 gm/dL from baseline. Major bleeding events were further examined as events that were deemed life threatening and/or fatal.|First dose of study drug up to 15 months (while at risk)|Treated subjects with adverse events were considered “at risk” from the first dose of study drug up through 7 days after permanent study drug discontinuation, or the subjects’ discontinuation visit; or from randomization through 464 days, whichever is earlier. Adverse events classified as “study drug related” were included in the “at risk” set.||Participants|||Number
704199|NCT00097591|Primary|Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke|The endpoint in this measure is a combination of CV death, nonfatal MI, or nonfatal stroke. The data is presented by the study population, which is represented as follows: 1) subjects who presented with unstable angina and non-ST-segment elevation myocardial infarction (UA/NSTEMI), 2) subjects who presented with ST segment elevation myocardial infarction (STEMI), and 3) all subjects with acute coronary syndromes (ACS) (i.e. all subjects with UA/NSTEMI or STEMI).|Randomization up to 15 months|Intention-to-treat (ITT) population consisting of all subjects with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) who may or may not have received study drug||Participants|||Number
704200|NCT00097695|Secondary|Time to Almost Complete Symptom Relief|The time to almost complete symptom relief was defined as a score between 0 and 10 mm on the VAS for at least 3 consecutive measurements for all symptom.|5 days|||Hours||Inter-Quartile Range|Median
704201|NCT00097695|Secondary|Time to Regression (Start of Improvement) According to Patient|"This parameter assessed the time to regression (start of improvement) of observable(visible) symptoms according to the patients. Patients were asked Report date and time when you feel that your symptoms start to improve."|5 days|||Hours||Inter-Quartile Range|Median
704202|NCT00097695|Primary|Time to Onset of Symptom Relief (TOSR)|"The primary efficacy endpoint was TOSR assessed by the patient using a Visual Analogue Scale (VAS). The VAS is a scale used to measure intensity of each symptom of the attack at baseline and at the pre-determined time points throughout treatment period. It consists of a horizontal 10cm line, with the 0 point corresponding to a state where patient experiences no symptoms at all and the 10cm point represents the worst symptoms ever experienced by patient. The patient indicates his/her current state of symptoms by drawing a mark across the horizontal line.
TOSR was defined as the time between time of injection to time of first documented onset of symptom relief for the 3 primary symptoms: cutaneous swelling, cutaneous skin, and abdominal pain.
The primary symptom was based on the type of attack. For abdominal attacks, the single primary symptom was abdominal pain. For cutaneous attacks, the single primary symptom was either skin swelling or skin pain, whichever was most severe."|5 days|Time to onset of symptom relief - Controlled phase - ITT population (patients experiencing moderate to very severe acute cutaneous and/or abdominal HAE attacks)||Hours||Inter-Quartile Range|Median
704203|NCT00097708|Primary|Change in HAM-A Total Score|Hamilton Anxiety Rating Scale (HAM-A). Each of 14 symptoms categories is rated from 0=not present to 4=very severe. Numbers for all categories are summed to produce the total score. Total score ranges from 0=anxiety symptoms not present to 56=very severe anxiety symptoms across all 14 categories.|Baseline to week 8|||Units on a Scale||Full Range|Least Squares Mean
704204|NCT00097721|Secondary|Change From Baseline to Study Termination in Quality of Life Measures Using Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores|The FACT-B questionnaire consists of 36 questions each scored from 0-4. The total score is calculated by summing these scores. The total possible range is from 0 to 144. The higher scores indicate a better health-related quality of life. This measures emotional, functional, physical, and social well being as well as concerns specific to patients with breast cancer.|At Screening, Day 1 of each cycle, and 30 days after last dose of study drug|||units on a scale||Full Range|Median
704205|NCT00097721|Secondary|Overall Survival|Defined as the time from the start of study drug administration until death from any cause|From start of study drug administration to death|Per Protocol Population (Investigator Assessment)||days||Full Range|Median
704206|NCT00097721|Secondary|Progression Free Survival|Defined as the time from start of study drug administration until progressive disease or death from any cause during the study period in the absence of disease progression.|From start of study drug administration to progressive disease or death|Per Protocol Population (Investigator Assessment)||days||Full Range|Median
704207|NCT00097721|Secondary|Duration of Response|Measured from the time measurement criteria were met for complete response (CR) or partial response (PR) (whichever was first recorded) until the first date that recurrent progressive disease was objectively documented (taking as a reference for progressive disease the smallest measurements recorded since the treatment started).|From CR or partial response PR (whichever recorded first) to date of recurrent or progressive disease|Intent to Treat/Safety Population (Investigator Assessment)||days||Full Range|Median
704208|NCT00097721|Primary|Overall Response Rate Based on Response Evaluation Criteria in Solid Tumors (RECIST)|Defined as the percentage of subjects with CR or PR from the start of treatment until disease progression or recurrence. Lesions measured by computed tomography (CT) scan and magnetic resonance imaging (MRI). Objective response rate: complete response (CR-disappearance of all lesions)+ partial response (PR-30% decrease in lesion diameter), Progressive Disease (PD-20% increase in lesion diameter), stable disease (SD-neither shrinkage nor increase of lesions).|Confirmed 4 to 8 weeks after first observed|Per Protocol Population (Independent Reviewer Assessment)||percentage of participants|||Number
704209|NCT00097773|Secondary|Number of Participants With a Pulmonary Exacerbation Requiring Oral, Inhaled, or Oral Antibiotics|"The primary comparison is between the pooled culture-based group and the pooled cycled group. No interactions with ciprofloxacin were identified. A secondary comparison is between the pooled ciprofloxacin group vs the pooled placebo group. Descriptive results are provided for the pooled treatment groups.
Participants are represented once in the cycled and culture-based therapy columns, and once in the cipro and placebo columns."|Measured over the 18 month time period|Intent to treat||participants|||Number
704212|NCT00097786|Primary|Percentage of Patients Reaching the Endpoint: Core Cardiovascular Morbidity and Mortality Event - Nateglinide Versus Non-nateglinide|The core cardiovascular endpoint was defined as a cardiovascular morbidity/mortality event including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and hospitalization for congestive heart failure.|Mean patient duration of 5.8 years|Full Analysis Set: All patients in the randomized set with the exception of patients from 10 Mexican sites closed for severe Good Clinical Practice deficiencies.||Percentage of patients|||Number
704213|NCT00097786|Primary|Percentage of Patients Reaching the Endpoint: Extended Morbidity and Mortality Event - Nateglinide Versus Non-nateglinide|The extended cardiovascular endpoint was defined as a cardiovascular morbidity/mortality event including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, revascularization procedure, hospitalization for congestive heart failure, and hospitalization for unstable angina.|Mean patient duration of 5.6 years|Full Analysis Set: All patients in the randomized set with the exception of patients from 10 Mexican sites closed for severe Good Clinical Practice deficiencies.||Percentage of patients|||Number
704214|NCT00097786|Primary|Percentage of Patients Reaching the Endpoint: Progression to Diabetes - Nateglinide Versus Non-nateglinide|Progression to diabetes was determined by (a) an algorithm based on central laboratory measurements of fasting plasma glucose and/or a 2 hour oral glucose tolerance test or (b) adjudication by the Diabetes Endpoint Adjudication Committee.|Mean patient duration of 4.2 years|Full Analysis Set: All patients in the randomized set with the exception of patients from 10 Mexican sites closed for severe Good Clinical Practice deficiencies.||Percentage of patients|||Number
704215|NCT00097786|Primary|Percentage of Patients Reaching the Endpoint: Core Cardiovascular Morbidity and Mortality Event - Valsartan Versus Non-valsartan|The core cardiovascular endpoint was defined as a cardiovascular morbidity/mortality event including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and hospitalization for congestive heart failure.|Mean patient duration of 5.8 years|Full Analysis Set: All patients in the randomized set with the exception of patients from 10 Mexican sites closed for severe Good Clinical Practice deficiencies.||Percentage of patients|||Number
704216|NCT00097786|Primary|Percentage of Patients Reaching the Endpoint: Extended Morbidity and Mortality Event - Valsartan Versus Non-valsartan|The extended cardiovascular endpoint was defined as a cardiovascular morbidity/mortality event including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, revascularization procedure, hospitalization for congestive heart failure, and hospitalization for unstable angina.|Mean patient duration of 5.6 years|Full Analysis Set: All patients in the randomized set with the exception of patients from 10 Mexican sites closed for severe Good Clinical Practice deficiencies.||Percentage of patients|||Number
704217|NCT00097786|Primary|Percentage of Patients Reaching the Endpoint: Progression to Diabetes - Valsartan Versus Non-valsartan|Progression to diabetes was determined by (a) an algorithm based on central laboratory measurements of fasting plasma glucose and/or a 2 hour oral glucose tolerance test or (b) adjudication by the Diabetes Endpoint Adjudication Committee.|Mean patient duration of 4.2 years|Full Analysis Set: All patients in the randomized set with the exception of patients from 10 Mexican sites closed for severe Good Clinical Practice deficiencies.||Percentage of patients|||Number
704218|NCT00097981|Secondary|Engraftment: Number of Participants Who Underwent Engraftment|Engraftment is the process of transplanted stem cells reproducing new cells.|From randomization until death or as assessed up to 2 years post last participant last treatment visit|Intent-to-treat: Participants who were randomized to receive the treatment and who underwent transplantation.||Participants|||Number
704219|NCT00097981|Secondary|Transplantation: Number of Participants Who Underwent Transplantation (Peripheral Stem Cell / Bone Marrow)||From randomization until death or as assessed up to 2 years post last participant last treatment visit|Intent-to-treat: Participants who were randomized to receive the treatment.||Participants|||Number
704220|NCT00097981|Secondary|Overall Survival: Number of Participants Died Due to Any Cause||From randomization until death or as assessed up to 2 years post last participant last treatment visit|Intent-to-treat: Participants who were randomized to receive the treatment.||Participants|||Number
704221|NCT00097981|Secondary|Time to Progression|Time to progression is the interval between the date of randomization until disease progression or death due to progression.|From randomization until death or as assessed up to 2 years post last participant last treatment visit|Intent-to-treat: Participants who were randomized to receive the treatment.||Days||95% Confidence Interval|Median
704222|NCT00097981|Secondary|Time to 1st Response|Time to first response was defined as the interval from date of randomization to date of achieving a partial response (PR) or better according to the current European Group for Blood and Marrow Transplantation (EBMT) criteria. According to EBMT criteria, PR is defined as not all CR criteria + 50 percentage or more reduction in serum monoclonal paraprotein.|From Cycle 2 until 28 days following completion of treatment|Intent-to-treat: Participants who were randomized to receive the treatment.||Days||95% Confidence Interval|Median
704223|NCT00097981|Secondary|Overall Response: Number of Participants Who Achieved a Complete Response (CR) or Partial Response (PR)|Overall response to study medication is defined as number of participants who acheived a complete response (CR) or partial response (PR) by the local investigator according to the current European Group for Blood and Marrow Transplantation (EBMT) criteria. According to EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein + plus no increase in size or number of lytic bone lesions; and PR is defined as not all CR criteria + 50 percentage or more reduction in serum monoclonal paraprotein.|From Cycle 2 until 28 days following completion of treatment|Intent-to-treat: Participants who were randomized to receive the treatment.||Participants|||Number
704224|NCT00097981|Primary|Complete Response Rate: Number of Participants Who Achieved a Complete Response|Complete response rate to study medication is defined as number of participants who acheived complete response by the local investigator according to the current European Group for Blood and Marrow Transplantation (EBMT) criteria. According to EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein + plus no increase in size or number of lytic bone lesions. Complete response was assessed at the beginning of every treatment cycle prior to treatment, starting at Cycle 2.|From Cycle 2 until 28 days following completion of treatment|Intent-to-treat: Participants who were randomized to receive the treatment.||Participants|||Number
704248|NCT00098254|Primary|The Number of Participants With Adverse Events|Here are the total number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|5 1/2 years|||Participants|||Number
704230|NCT00098059|Primary|Maximum Observed Plasma Concentration of Penciclovir (Cmax)|PK parameter; penciclovir is the active metabolite of famciclovir.|plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose|Includes all 27 patients enrolled in Part A of the study.||μg/mL||Full Range|Mean
704231|NCT00098059|Primary|Safety and Tolerability of a Single-dose of Famciclovir in Part A of the Study.|A patient with multiple adverse events (AEs) within the primary system organ class is counted only once in total row.|8 hours and 24 hours after study drug administration (Part A)|Includes all 27 patients enrolled in Part A of the study.||participants|||Number
704232|NCT00098059|Secondary|Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study|Overall acceptability of study medication was determined by caretaker response.|Day 8 at home: after swallowing last dose|Includes all 47 patients enrolled in Part B of the study. Response was not available for 1 patient in the 2 to <6 years and 6 to <=12 years groups.||participants|||Number
704233|NCT00098059|Secondary|Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study.|Overall acceptability of the study medication was determined by caretaker response.|Day 1 at clinic: after swallowing first dose|Includes all 47 patients enrolled in Part B of the study.||participants|||Number
704234|NCT00098059|Secondary|Overall Acceptability of Pediatric Oral Formulation by Patients in Part A of the Study.|Overall acceptability of the study medication was determined by caretaker response.|Day 1, after swallowing the dose.|Includes all 27 patients enrolled in Part A of the study.||participants|||Number
704235|NCT00098254|Secondary|Secondary Pharmacoproteomic Modulation Targets|Secondary pharmacoproteomic modulation targets (mTOR, EGFR, Src, NFkB, STAT1, TGFa, p38, Jak 1, lkB, IGFR, p-mTOR, p-EGFR, p-Src, p-NFkB, p-STAT1, Phospho-p38, p-Jak1, p-lkB,Pyk2, p-Pyk2, VEGFR-2, GSK3beta, p-GSK3beta, p-bad, p-Bcl-2, PCNA, Fos, Raf, CREB, Rho, avbeta3complex, Bad, CD34, VEGFR-1, bfGF, vWF, Factor VIII, Annexin V, Bcl-2).|60 months|The analysis for this outcome measure was not performed. Endpoint lost interest when mutation analysis was felt to be more important.||mg/ml|||Number
704236|NCT00098254|Secondary|Percent of Pts With Primary Pharmacoproteomic Modulation Targets|Pharmacoproteomic modulation targets (AKT, p-AKT, ERK 1/2, MEK, Cyclin D, p-ERK 1/2, p-MEK, pMEK, eNOA, p-eNOA, Cleaved PARP, PDGFRbeta, p-PDGFRbeta,Cyclin D, CD31, PARP. Caspase 9, Caspase 3, Cleaved Caspase-9 Cleaved Caspase 3)|60 months|The analysis for this outcome measure was not performed. Endpoint lost interest when mutation analysis was felt to be more important.||mg/ml|||Number
704237|NCT00098254|Secondary|Percentage of Participants With BRAF Mutations|Extracted DNA was subjected to an initial PCR using a single primer set encompassing codom V600. Pyrosequencing was carried out on a Qiagen PyroMaark Q24 system.|60 months|The analysis for this outcome measure was not performed. Endpoint lost interest when mutation analysis was felt to be more important.||Percent of participants|||Number
704238|NCT00098254|Secondary|Percent of Participants Who Had Cytokine Profiling for IL-6 and IL-8|Serial plasma samples were collected from all patients at pretreatment (baseline - day 0), and on days 14, 28, and 54. The concentrations of the cytokines were determined with recombinant standards and expressed as picograms per milliliter (pg/ml).|60 months|The analysis for this outcome measure was not performed. Endpoint lost interest when mutation analysis was felt to be more important.||Percent of participants|||Number
704239|NCT00098254|Secondary|Percent of Participants Who Had Immunohistochemical Analysis Performed for Raf, MEK, ERK, ERK-1 and p90RSK,ERK, E Twenty-six (ETS)-Like Transcription Factor 1 (ELK-1) and p90Ribosomal S6 Kinase (p90RSK).|Immunohistochemical analysis performed by using state specific antibodies against Raf, methyl ethyl ketone (MEK), extracellular-signal regulated kinase (ERK), and two downstream substrates of ERK, E twenty-six (ETS)-like transcription factor 1 (ELK-1) and p90Ribosomal S6 kinase (p90RSK).|59 months|The analysis for this outcome measure was not performed. Endpoint lost interest when mutation analysis was felt to br more important.||Percent of participants|||Number
704240|NCT00098254|Secondary|Percentage of Participants With an Increase or Decrease in the Reverse Contrast Transfer Rate (Kep), Forward Contrast Transfer Rate (Ktrans), and Extravascular Fraction (Ve) With the Dynamic Contrast Enhanced Magnetic Resonance Imaging (DCE-MRI)|DCE-MRI was used to evaluate changes (e.g. decrease/increase in Ve, Ktrans, Kep value) in vascularity and quality of index lesions to provide early indication of treatment effect before changes in size can be perceived on CT. Changes were reflected in a decrease/increase of Ve, Ktrans, or Kep (Kep, Ve, Ktrans measurements at day 0, day 14 and the difference between the day 14 and the day 0 measurements (day 14-day 0).|59 months|||Percentage of participants|||Number
704241|NCT00098254|Secondary|Progression Free Survival Associated With Basic Fibroblast Growth Factor (bFGF)|Serum plasma is collected at the beginning of each cycle during the course of the study and analyzed by the enzyme-linked immunosorbent assay (ELISA).|17 months|||months||95% Confidence Interval|Median
704242|NCT00098254|Secondary|Overall Survival Associated With Basic Fibroblast Growth Factor (bFGF)|Serum plasma is collected at the beginning of each cycle during the course of the study and analyzed by the enzyme-linked immunosorbent assay (ELISA).|42 months|14 patients with day 28 FGF >6 and 14 patients with FGF <6.||months||95% Confidence Interval|Median
704243|NCT00098254|Secondary|Correlation of Response to Treatment With KRAS Mutational Status|Mutational analysis of these genes was performed on paraffin-imbedded tissue blocks from prior pathologic specimens. Disease control rate was correlated with KRAS mutational status. Disease control rate was defined as complete remission (CR) + partial remission (PR)+ stable disease (SD).|42 months|11/34 KRAS positive; 23/34 KRAS negative 5/23 EGFR positive; 18/23 EGFR negative||percentage of participants|||Number
704244|NCT00098254|Secondary|Cytokine Levels|Serial plasma samples were collected from all patients and cytokine levels were measured. The concentrations of the cytokines were determined with recombinant standards and expressed as picograms per milliliter (pg/ml).|54 days|||pg/ml||Inter-Quartile Range|Median
704245|NCT00098254|Secondary|Overall Survival Reported Separately for Participants With a Change in PLGF Below 11 pg/ml and Above 12 pg/ml|Difference in placental derived growth factor (PLGF) between day 28 and day 0 of < 11 pg/ml vs. > 12 pg/ml.|17 months|||months||95% Confidence Interval|Median
704246|NCT00098254|Secondary|Percent of Participants With Genotyping of CYP3A4/5 and 5 Polymorphisms|All patients will be genotyped for CYP3A4/5 and 5 polymorphisms.|58 months|The analysis for this outcome measure was not performed. Endpoint lost interest when mutation analysis was felt to be more important.||Percent of participants|||Number
704247|NCT00098254|Secondary|Overall Survival|Time between the first day of treatment to the days of death.|17 months|||months||95% Confidence Interval|Median
704249|NCT00098254|Primary|Progression Free Survival|"Time between the first day of treatment to the day of disease progression. Progressive disease is at least a 20% increase in the sum of the longest diameter of target lesions.
Appearance of one or more new lesions and/or unequivocal progressions of existing non-target lesions."|17 months|||months||95% Confidence Interval|Median
704250|NCT00098254|Primary|Response Rate|Percentage of participants with response rate = CR + PR. Response will be evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR (complete response) is the disappearance of all target lesions; PR (partial response) is a 30% decrease in the sum of the longest diameter of target lesions; PD (progressive disease) is a 20% increase in the sum of the longest diameter of target lesions; and SD (stable disease) are small changes that do not meet the above criteria. Please see the Protocol Link module for additional information about RECIST if desired.|17 months|||percentage of participants||95% Confidence Interval|Number
704251|NCT00098293|Post-Hoc|Percentage of Participants With HIV-1 RNA Levels of Less Than 400 Copies/mL and Less Than 50 Copies/mL at Week 96 for Enhanced Sensitivity Trofile Assay (ESTA) R5 Participants|Percentage of participants with HIV-1 RNA levels of less than 400 copies/mL and less than 50 copies/mL were not analyzed for maraviroc once daily, then twice daily arm in order to avoid misinterpretation due to possible bias due to the fact that only a non-random sample of participants in the terminated arm were re-assayed with ESTA.|Week 96|FAS population; 'N' number of participants analyzed included ESTA R5 participants who had R5 tropic virus by ESTA at screening. Missing data (MD) imputed as failure (F); that is, participants with missing data classified as not achieving the viral load criterion (MD=F).||Percentage of participants|||Number
704252|NCT00098293|Post-Hoc|Percentage of Participants With HIV-1 RNA Levels of Less Than 400 Copies/mL and Less Than 50 Copies/mL at Week 48 for Enhanced Sensitivity Trofile Assay (ESTA) R5 Participants|Percentage of participants with HIV-1 RNA levels of less than 400 copies/mL and less than 50 copies/mL were not analyzed for maraviroc once daily, then twice daily arm in order to avoid misinterpretation due to possible bias due to the fact that only a non-random sample of participants in the terminated arm were re-assayed with ESTA.|Week 48|FAS population; 'N' number of participants analyzed included ESTA R5 participants who had R5 tropic virus by ESTA at screening. Missing data (MD) imputed as failure (F); that is, participants with missing data classified as not achieving the viral load criterion (MD=F).||Percentage of participants|||Number
704253|NCT00098293|Other Pre-specified|Percentage of Participants With Viral Load of Less Than 400 Copies/mL and Less Than 50 Copies/mL of HIV-1 RNA at Week 96||Week 96|FAS population included all the randomized participants who had taken at least 1 dose of the study medication. Missing data (MD) imputed as failure (F); that is, participants with missing data classified as not achieving the viral load criterion (MD=F).||Percentage of participants|||Number
704254|NCT00098293|Secondary|Percentage of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL at Week 48 and Week 96 by Overall Susceptibility Score (OSS) at Screening|Association between baseline resistance and virological response was assessed as percentage of participants with HIV-1RNA levels less than 50 copies/mL by OSS at screening. OSS categorized as 0, 1, 2, >3 (maximum value of 6) and calculated as the sum of the net assessment of in-vitro phenotypic and genotypic susceptibility using a binary scoring system (0= resistant, 1= sensitive or susceptible) for each antiretroviral agent in OBT. Higher scores indicate greater susceptibility.|Baseline, Week 48, Week 96|Data not analyzed because of insufficient diversity amongst participants with respect to baseline resistance due to the study entry criteria regarding baseline resistance.|||||
704255|NCT00098293|Secondary|Number of Participants With Efavirenz Associated Mutations at Time of Treatment Failure Through Week 48 and 96|Genotypic resistance: mutations at screening by MBPSGT assay, repeated if viral load >500 copies/mL at treatment failure through week 48, 96. Efavirenz mutation:lysine to aspargine at r103(K103N);tyrosine to cysteine/isoleucine at r181(Y181C/I);tyrosine to cysteine/leucine/histidine at r188(Y188C/L/H);glycine to alanine/serine at r190(G190A/S);valine to alanine to r106(V106A);leucine to isoleucine at r100(L100I);alanine to glycine at r98(A98G);lysine to glutamic acid at r101(K101E);valine to isoleucine at r108(V108I);proline to histidine at r225(P225H);methionine to leucine at r230(M230L).|Screening, time of failure through Week 48, Week 96|FAS population; n=participants with treatment failure at specified time points for each arm group respectively. Data not analyzed for participants originally randomized to maraviroc once daily arm since after termination focus shifted from efficacy, safety to only safety as reflected in abbreviated set of efficacy noted in amended planned analysis.||participants|||Number
704256|NCT00098293|Secondary|Number of Participants With NRTI Associated Mutations at Time of Treatment Failure Through Week 48 and 96|Genotypic resistance to NRTIs was assessed by identification of relevant mutations at screening using MBPSGT assay and repeated for all participants with HIV-1 viral load more than 500 copies/mL at treatment failure through week 48 and week 96. Following mutations associated with NRTIs were summarized at time of failure: Any zidovudine/lamivudine (Zid/Lam), Any thymidine analogue-associated mutation (TAM), methionine (M) to valine/isoleucine (V/I) substitution at residue (r) 184 (M184V/I), lysine (K) to arginine (R) substitution at residue 65 (K65R) and any other NRTI mutations.|Screening, time of failure through Week 48, Week 96|FAS population included all the randomized participants who had taken at least 1 dose of the study medication. ‘n’ is signifying those participants who experienced treatment failure, defined as discontinuation due to insufficient response at specified time points for each arm group respectively.||participants|||Number
704257|NCT00098293|Secondary|Number of Participants With Phenotypic Resistance at Time of Treatment Failure Through Week 48 and 96|Phenotypic resistance to nucleoside reverse transcriptase inhibitors (NRTIs) and non-nucleoside reverse transcriptase inhibitors (NNRTIs) assessed at screening by Monogram Bioscience PhenoSense genotype (MBPSGT) assay, repeated if viral load >500 copies/mL at treatment failure through week 48, 96. Phenotypic resistance to maraviroc was assumed in maraviroc treatment failures with X4-using virus and in R5 maraviroc treatment failures using Monogram Bioscience PhenoSense Entry Assay. Phenotypic resistance to zidovudine, lamivudine, efavirenz and maraviroc at time of failure was summarized.|Screening, time of failure through Week 48, Week 96|FAS population included all the randomized participants who had taken at least 1 dose of the study medication. ‘n’ is signifying those participants who experienced treatment failure, defined as discontinuation due to insufficient response at specified time points for each arm group respectively.||participants|||Number
704522|NCT00091507|Secondary|Cardiac Arrest|Outcome for all participants who had a cardiac arrest from initial contact in the prehospital setting through their subsequent hospitalization.|1 to 18 hours (From prehospital setting through hospitalization.)|||participants|||Number
704258|NCT00098293|Secondary|Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 96|Number of participants per tropism status (R5, X4, DM, or NR/NP) at baseline and time of treatment failure analyzed through week 96 visit. Treatment failure defined as insufficient clinical response. Tropism result was censored for participants with viral load <500 copies/mL at time of treatment failure categorized as BLQ. The assessment for time of treatment failure was defined as last on treatment assessment.|Baseline, time of failure through Week 96|FAS population included all the randomized participants who had taken at least 1 dose of the study medication. ‘N’ (number of participants analyzed) is signifying those participants who experienced treatment failure, defined as discontinuation due to insufficient response and had tropism assessment at baseline.||participants|||Number
704259|NCT00098293|Secondary|Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 48|Number of participants per tropism status (C-X-C chemokine receptor 5 {CCR5} [R5], C-X-C chemokine receptor type 4 {CXCR4} [X4], Dual/mixed [DM], or Non-reportable/Non-phenotypable [NR/NP]) at baseline and time of treatment failure analyzed through week 48 visit. Treatment failure: discontinuation due to insufficient clinical response. Tropism result was censored for participants with viral load <500 copies/mL at time of treatment failure categorized as below lower limit of quantification (BLQ). The assessment for time of treatment failure was defined as last on treatment assessment.|Baseline, time of failure through Week 48|FAS population included all the randomized participants who had taken at least 1 dose of the study medication. ‘N’ (number of participants analyzed) is signifying those participants who experienced treatment failure, defined as discontinuation due to insufficient response and had tropism assessment at baseline.||participants|||Number
704260|NCT00098293|Secondary|Time to Virologic Failure|Time to virologic failure based on observed HIV-1 RNA levels and failure events (death;permanent discontinuation of drug;lost to follow-up [LTFU];new anti-retroviral drug added [except background drug change to drug of same class];or on open label for early non-response or rebound). Failure:at Time 0 if level not <400 copies/mL(2 consecutive visits) before events or last available visit;at time of earliest event if level <400 copies/mL(2 consecutive visits);failure if level >=400 copies/mL(2 consecutive visits) or 1 visit >=400 copies/mL followed by permanent discontinuation of drug or LTFU.|Week 48, Week 96|FAS population; Data not analyzed for participants originally randomized to maraviroc once daily arm since after termination, focus was shifted from efficacy and safety to only safety as reflected in the abbreviated set of efficacy measures noted in the amended planned analysis.||days||95% Confidence Interval|Median
704261|NCT00098293|Secondary|Change From Baseline in Lymphocyte Cluster of Differentiation 8 (CD8) Count at Week 48 and 96|Baseline value calculated as the average of pre-dose measurements collected at screening and immediately pre-dose. Change from baseline in lymphocyte CD8 count at Week 48 and 96 was not analyzed for participants originally randomized to maraviroc once daily arm since after termination, focus was shifted from efficacy and safety to only safety as reflected in the abbreviated set of efficacy measures noted in the amended planned analysis.|Baseline, Week 48, Week 96|FAS population included all the randomized participants who had taken at least 1 dose of the study medication. 'N' (number of participants analyzed) signifies participants evaluable for this measure. Missing values were imputed using LOCF.||cells/µL||Standard Deviation|Mean
704262|NCT00098293|Secondary|Change From Baseline in Lymphocyte Cluster of Differentiation 4 (CD4) Count at Week 48 and 96|Baseline value calculated as the average of pre-dose measurements collected at screening and immediately pre-dose.|Baseline, Week 48, Week 96|FAS population included all the randomized participants who had taken at least 1 dose of the study medication. 'N' (number of participants analyzed) signifies participants evaluable for this measure. Missing values were imputed using LOCF.||cells per microliter (cells/µL)||Standard Deviation|Mean
704263|NCT00098293|Secondary|Time-Averaged Difference (TAD) in log10-transformed HIV-1 RNA Levels|TAD from baseline was calculated as area under the curve (AUC) of HIV-1 RNA load (log10 copies/mL) divided by time period minus baseline HIV-1 RNA load (log10 copies/mL). Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose. Data not analyzed for participants originally randomized to maraviroc once daily arm since after termination, focus was shifted from efficacy and safety to only safety as reflected in the abbreviated set of efficacy measures noted in the amended planned analysis.|Baseline up to Week 48 and Week 96|FAS population included all the randomized participants who had taken at least 1 dose of the study medication. TAD imputed as 0 for participants who discontinued. TAD calculated using the last non-missing value prior to the analysis time point for participants with a missing value at the analysis time point but who had not discontinued.||log10 copies/mL||Standard Error|Least Squares Mean
704264|NCT00098293|Secondary|Change From Baseline in Log 10-transformed Plasma Viral Load (HIV-1 RNA) Levels at Week 48 and 96|Change from baseline in log 10-transformed plasma viral load (HIV-1 RNA) levels (log10 copies/mL). Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.|Baseline, Week 48, Week 96|FAS population. Missing values for viral load at week 48 and 96 were imputed as baseline value for participants who discontinued and as last observation carried forward (LOCF) for participants who did not discontinue for maraviroc twice daily and efavirenz once daily arm and as LOCF for participants randomized to maraviroc once daily arm.||log10 copies/mL||Standard Deviation|Mean
704265|NCT00098293|Secondary|Percentage of Participants With HIV-1 RNA Levels of Less Than 400 Copies/mL and Less Than 50 Copies/mL at Week 96 Analyzed Using Logistic Regression||Week 96|FAS population included all the randomized participants who had taken at least 1 dose of the study medication. Missing data (MD) imputed as failure (F); that is, participants with missing data classified as not achieving the viral load criterion (MD=F).||Percentage of participants|||Number
704266|NCT00098293|Secondary|Percentage of Participants With HIV-1 RNA Levels of Less Than 400 Copies/mL and Less Than 50 Copies/mL at Week 48 Analyzed Using Logistic Regression||Week 48|FAS population included all the randomized participants who had taken at least 1 dose of the study medication. Missing data (MD) imputed as failure (F); that is, participants with missing data classified as not achieving the viral load criterion (MD=F).||Percentage of participants|||Number
704304|NCT00098371|Primary|Progression-free Survival for All Patients as Assessed Using Standard Kaplan-Meier Methods|PFS was calculated from the date of study entry until time of disease progression or death, whichever came first, censoring patients alive and relapse free at last follow up. Patients who withdrew from study to undergo an allogeneic SCT were censored at the time of transplantation.|Up to 5 years|||months||95% Confidence Interval|Median
704267|NCT00098293|Primary|Percentage of Participants With Viral Load of Less Than 400 Copies/mL and Less Than 50 Copies/mL of HIV-1 RNA at Week 48 for Per Protocol (PP) Population|Percentage of participants with viral load of less than 400 copies/mL and less than 50 copies/mL of HIV-1 RNA were not analyzed for participants originally randomized to maraviroc once daily arm since after termination, focus was shifted from efficacy and safety to only safety as reflected in the abbreviated set of efficacy measures noted in the amended planned analysis.|Week 48|Per protocol (PP) population included all randomized participants who had taken at least 1 dose of study medication, were treated for at least 14 days or discontinued before this time due to treatment failure, were >80% compliant with randomized treatment and had no violation of any inclusion or exclusion criteria, which affected efficacy. MD=F.||Percentage of participants|||Number
704268|NCT00098293|Primary|Percentage of Participants With Viral Load of Less Than 400 Copies/Milliliter [Copies/mL] and Less Than 50 Copies/mL of Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) at Week 48 for Full Analysis Set (FAS) Population||Week 48|FAS population included all the randomized participants who had taken at least 1 dose of the study medication. Missing data (MD) imputed as failure (F); that is, participants with missing data classified as not achieving the viral load criterion (MD=F).||Percentage of participants|||Number
704269|NCT00098306|Secondary|Change From Baseline in Viral Load at Week 24 and Week 48 by Overall Susceptibility Score (OSS) at Screening|Association between baseline resistance and virological response was assessed as change in viral load by OSS at screening. OSS categorized as 0, 1, 2, >3 (maximum value of 6) and calculated as the sum of the net assessment of in-vitro phenotypic and genotypic susceptibility using a binary scoring system (0= resistant, 1= sensitive or susceptible) for each antiretroviral agent in OBT. Higher scores indicate greater susceptibility. Baseline value is the average of the values from screening, randomization and immediately pre-dose.|Baseline, Week 24 and Week 48|FAS; 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure. 'n' is number of participants with given OSS score at screening for each treatment arm at particular time-point. LOCF was used to impute missing values.||log10copies/mL||Standard Deviation|Mean
704270|NCT00098306|Secondary|Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 48|Number of participants per tropism status (R5, X4, DM, or NR/NP) at baseline and time of treatment failure analyzed through week 48 visit. Treatment failure defined as insufficient clinical response. HIV-1 RNA viral load <500 copies/mL categorized as BLQ. The assessment for time of treatment failure was defined as the last on treatment assessment.|Baseline and time of failure through week 48|FAS; ‘N’ (number of participants analyzed) is signifying those participants who experienced treatment failure, defined as discontinuation due to insufficient response and had tropism assessment at baseline.||participants|||Number
704271|NCT00098306|Secondary|Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 24|Number of participants per tropism status (C-X-C chemokine receptor 5 {CCR5} [R5], C-X-C chemokine receptor type 4 {CXCR4} [X4], Dual/mixed [DM], or Non-reportable/Non-phenotypable [NR/NP]) at baseline and time of treatment failure analyzed through week 24 visit. Treatment failure defined as discontinuation due to insufficient clinical response. HIV-1 RNA viral load <500 copies/mL categorized as below lower limit of quantification (BLQ). The assessment for time of treatment failure was defined as the last on treatment assessment.|Baseline and time of failure through week 24|FAS; ‘N’ (number of participants analyzed) is signifying those participants who experienced treatment failure, defined as discontinuation due to insufficient response and had tropism assessment at baseline.||participants|||Number
704272|NCT00098306|Secondary|Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure at Week 48|Number of participants with GSS and PSS were used as surrogates for assessing genotype and phenotype. Genotypic and phenotypic resistance to PIs, NRTIs and NNRTIs were evaluated at screening and time of treatment failure analyzed through week 48 visit, by Monogram Biosciences PhenoSense GT assay. Score was determined for each drug in OBT, giving 1: drug ‘sensitive'/'susceptible' and 0: 'resistant'. GSS and PSS score range:0 to >3. Genotypic enfuvirtide value was used for PSS, no phenotypic enfuvirtide was recorded.|Screening and time of failure through week 48|FAS; ‘N’ (number of participants analyzed) is signifying those participants who experienced treatment failure defined as discontinuation due to discontinuation due to insufficient response. 'n' is number of participants who were evaluable for the given change in GSS and PSS score for each arm group respectively.||participants|||Number
704273|NCT00098306|Secondary|Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24|Number of participants with GSS and PSS were used as surrogates for assessing genotype and phenotype. Genotypic and phenotypic resistance to PIs, NRTIs and NNRTIs were evaluated at screening and time of treatment failure analyzed through week 24 visit, by Monogram Biosciences PhenoSense GT assay. Score was determined for each drug in OBT, giving 1: drug ‘sensitive'/'susceptible' and 0: 'resistant'. GSS and PSS score range:0 to >3. Genotypic enfuvirtide value was used for PSS, no phenotypic enfuvirtide was recorded.|Screening and time of failure through week 24|FAS; ‘N’ (number of participants analyzed) is signifying those participants who experienced treatment failure defined as discontinuation due to insufficient response. 'n' is number of participants who were evaluable for the given change in GSS and PSS score for each arm group respectively.||participants|||Number
704274|NCT00098306|Secondary|Number of Participants With Genotypic Susceptibility Scores (GSS) and Phenotypic Susceptibility Score (PSS) at Screening|Number of participants with GSS and PSS were used as surrogates for assessing genotype and phenotype. Genotypic and phenotypic resistance to protease inhibitors(PIs), nucleoside reverse transcriptase inhibitors(NRTIs), non-nucleoside reverse transcriptase inhibitors(NNRTIs) were evaluated at screening (not at baseline), by Monogram Biosciences PhenoSense genotyping (GT) assay. Score was determined for each drug in OBT, giving 1:drug ‘sensitive'/'susceptible' and 0:'resistant'. GSS and PSS score range:0 to >3. Genotypic enfuvirtide value was used for PSS, no phenotypic enfuvirtide was recorded.|Screening|FAS included all the randomized participants who had taken at least one dose of the study medication.||participants|||Number
704302|NCT00098371|Primary|Toxicity|Toxicity determination based on NCI Common Toxicity Criteria version 3 and modified NCI Common toxicity guidelines for evaluating hematologic toxicity in leukemia.|Measurement prior to each infusion, at end of therapy, 2 months post-completion and post-treatment follow-up every 3 months for two years.|Grade 3 to 4 infections requiring IV antibiotics and were generally related to upper or lower respiratory infections or infections of indwelling central venous catheters.||percentage of patients|||Number
704275|NCT00098306|Primary|Change From Baseline in Log 10-transformed HIV-1 RNA Levels at Week 48|Change from baseline in log 10-transformed plasma viral load (HIV-1 RNA) levels (log10 copies/mL). Baseline value calculated as average of pre-dose measurements collected at screening, randomization and immediately pre-dose.|Baseline and Week 48|FAS included all the randomized participants who had taken at least one dose of the study medication. Missing values for viral load at week 48 have been imputed as the baseline value for participants who discontinued and as LOCF for participants who did not discontinue.||log10 copies/mL||Standard Error|Least Squares Mean
704276|NCT00098306|Secondary|Time-Averaged Difference (TAD) From Baseline in log10 Transformed HIV-1 RNA Levels|TAD from baseline was calculated as area under the curve of HIV-1 RNA load (log10 copies/mL) divided by time period minus baseline HIV-1 RNA load (log10 copies/mL). Baseline value calculated as the average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.|Baseline to Week 24 and Week 48|FAS included all the randomized participants who had taken at least one dose of the study medication. Missing data imputed as 0 for participants who discontinued and through last available observation for participants who did not discontinue.||log10 copies/mL||Standard Error|Least Squares Mean
704277|NCT00098306|Secondary|Time to Virological Failure|Time to virologic failure based on observed HIV-1 RNA levels and failure events (death;permanent discontinuation of drug;lost to follow-up [LTFU];new anti-retroviral drug added [except background drug change to drug of same class];or on open label for early non-response or rebound). Failure:at Time 0 if level not <400 copies/mL(2 consecutive visits) before events or last available visit;at time of earliest event if level <400 copies/mL(2 consecutive visits);failure if level >=400 copies/mL(2 consecutive visits) or 1 visit >=400 copies/mL followed by permanent discontinuation of drug or LTFU.|Week 48|FAS included all the randomized participants who had taken at least one dose of the study medication.||days||95% Confidence Interval|Median
704278|NCT00098306|Secondary|Change From Baseline in CD8 Cell Count at Week 24 and 48|Change from baseline in CD8 cell count measured as cells/µL. Baseline value calculated as the average of pre-dose measurements collected at screening and immediately pre-dose.|Baseline, Week 24 and 48|FAS included all the randomized participants who had taken at least one dose of the study medication. 'N' (number of participants analyzed) signifies participants evaluable for this measure. Missing values were imputed using LOCF.||cells/µL||Standard Error|Least Squares Mean
704279|NCT00098306|Secondary|Change From Baseline in CD4 Cell Count at Week 24 and 48|Change from baseline in CD4 cell count measured as cells/µL. Baseline value calculated as the average of pre-dose measurements collected at screening and immediately pre-dose.|Baseline, Week 24 and 48|FAS included all the randomized participants who had taken at least one dose of the study medication. 'N' (number of participants analyzed) signifies participants evaluable for this measure. Missing values were imputed using LOCF.||cells/µL||Standard Error|Least Squares Mean
704280|NCT00098306|Secondary|Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Cell Count at Baseline|Baseline value calculated as average of pre-dose measurements collected at screening and immediately pre-dose.|Baseline|FAS included all the randomized participants who had taken at least one dose of the study medication. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||cells per microliter (cells/µL)||Standard Deviation|Mean
704281|NCT00098306|Secondary|Percentage of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL||Week 24 and 48|"FAS included all the randomized participants who had taken at least one dose of the study medication. Missing data was imputed as failure which was defined as not meeting the criteria of less than 50 copies/mL of HIV-1 RNA levels."||percentage of participants|||Number
704282|NCT00098306|Secondary|Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/mL or With at Least 1.0 log10 Decrease From Baseline||Week 24 and 48|"FAS included all the randomized participants who had taken at least one dose of the study medication. Missing data was imputed as failure which was defined as not meeting the criteria of less than 400 copies/mL or with at least 1.0 log10 decrease from baseline of HIV-1 RNA levels."||percentage of participants|||Number
704283|NCT00098306|Secondary|Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/mL or With at Least 0.5 log10 Decrease From Baseline||Week 24 and 48|"FAS included all the randomized participants who had taken at least one dose of the study medication. Missing data was imputed as failure which was defined as not meeting the criteria of less than 400 copies/mL or with at least 0.5 log10 decrease from baseline of HIV-1 RNA levels."||percentage of participants|||Number
704284|NCT00098306|Secondary|Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/mL||Week 24 and 48|"FAS included all the randomized participants who had taken at least one dose of the study medication. Missing data was imputed as failure which was defined as not meeting the criteria of less than 400 copies/mL of HIV-1 RNA levels."||percentage of participants|||Number
704285|NCT00098306|Primary|Change From Baseline in Log 10-transformed HIV-1 RNA Levels at Week 24|Change from baseline in log 10-transformed plasma viral load (HIV-1 RNA) levels (log10 copies/mL). Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.|Baseline and Week 24|FAS included all the randomized participants who had taken at least one dose of the study medication. Missing values for viral load at week 24 have been imputed as baseline value for the participants who discontinued and as Last observation carried forward (LOCF) for participants who did not discontinue.||log10 copies/mL||Standard Error|Least Squares Mean
704286|NCT00098306|Primary|Log 10-transformed Human Immunodeficiency Virus Ribonucleic Acid (HIV-1 RNA) Levels at Baseline|Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.|Baseline|Full analysis set (FAS) included all the randomized participants who had taken at least one dose of the study medication.||log10 copies/milliliter(log10 copies/mL)||Standard Deviation|Mean
704287|NCT00098345|Secondary|World Health Organisation (WHO) Performance Status|Number of patients demonstrating a worsening (increase in score of one or more from baseline) in WHO PS from baseline to 24 weeks. WHO PS is scored zero (Fully active) to 4 (completely disabled)|Performance status was assessed using the WHO criteria at baseline and because SD lasting for at least 24 weeks was used in the definition of disease control (in addition to confirmed objective response), WHO PS at 24 weeks was evaluated.|||Participants|||Number
704303|NCT00098371|Primary|Overall Survival|Overall survival data will be reported on a 3-month basis for 5 years|Up to 5 years|||months||95% Confidence Interval|Median
704288|NCT00098345|Secondary|Symptomatic Response|Number of participants with a reduction of frequency and improvement in consistency of stool to normal (no more than 2 solid stools daily without concomitant anti-diarrheal medication) following administration of Caprelsa (vandetanib) denoted a symptomatic CR. An improvement in stool consistency to mostly semisolid and decrease in stool frequency to 50% or greater denoted symptomatic PR.|Symptomatic diarrhea was assessed using stool frequency and consistency diaries. Baseline was established using the average of the 4 days immediately prior to first dose on Day 5. Diaries were completed every day for the first 6 months on study drug.|||Participants|||Number
704289|NCT00098345|Secondary|Biochemical Response Calcitonin (CTN)|A patient's best biochemical response was calculated from assessments performed at baseline and during treatment. Responders were those patients with a confirmed best biochemical response of Complete Response or Partial (i.e. complete normalization of CTN or at least a 50% decrease in CTN from baseline).|Blood samples for analysis of CTN taken on Day 1 (every 3 hours for 24 hours), then a single sample on Day 5, weekly through the first 2 assessment periods, monthly (prior to amendment 7) and every 12 weeks (following amendments) until discontinuation|||Participants|||Number
704290|NCT00098345|Secondary|Disease Control Rate|Disease control rate was defined as the number of patients who had a best response of Complete Response (CR), or Partial Response (PR) or stable disease (SD) ≥24 weeks as defined according to RECIST 1.0.|Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0.|||Participants|||Number
704291|NCT00098345|Secondary|Duration of Objective Response|Median duration of objective response as defined according to RECIST 1.0 from onset of response until data of objective disease progression or death from any cause in days.|Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0.|||days||95% Confidence Interval|Median
704292|NCT00098345|Secondary|Progression Free Survival|Median time to progression defined according to RECIST 1.0 (months) from randomisation until objective disease progression or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment.|Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0.|Upper limit is a censored value||months||Full Range|Median
704293|NCT00098345|Primary|Objective Response Rate|The ORR is the number of patients that are responders ie those patients with a confirmed best objective response of complete response (CR) or partial response (PR) defined according to RECIST 1.0.|Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0.|||Participants|||Number
704294|NCT00098371|Secondary|Comparison of Clinical Response and Tumor Lysis in Vivo With Drug-induced Apoptosis and Mitochondrial Perturbation in Vitro as Assessed by Flow Cytometry|CLL cells will be incubated with control or flavopiridol (1 or 2.8 microMolar) for 4-hours followed by a 20 hours in media with 10% heat-inactivated human serum. Assessment of apoptosis following exposure of human CLL cells will be performed using annexin/PI flow cytometry. Patient samples with greater than 50% live cells (annexin-/PI-) following exposure to 2.8 microMolar flavopiridol will be considered to have insensitive disease. Patients whose CLL cells have less than 50% live cells at 1 microMolar will be considered to have highly sensitive disease.|At baseline|A subset of patients who had sufficient material were analyzed according to response only.||percentage of priming cells||Standard Deviation|Mean
704295|NCT00098371|Secondary|Levels of Mcl-1 mRNA, Mcl-1 Protein, HIF-1alpha Protein, HIF-1alpha mRNA, NF-kappaB Activation, Total IkB, IkB Phosphorylation, GSK-beta Activity, and IL-6 Target Genes (i.e., STAT3)|Assessed by real time RT-PCR (mcl-1, HIF-1alpha), immunoblot analysis (mcl-1, HIF-1alpha, I-kappaB, I-kappaB phosphorylation, targets of IL-6), and electrophoretic mobility shift analysis (NF-kappaB activation)|At baseline, 4.5 hours (end of continuous infusion), 8 hours, and approximately 24 hours following initiation of therapy|Data was not collected and analyzed for this outcome|||||
704296|NCT00098371|Secondary|Correlation of Adverse Prognostic Factors With Response to Flavopiridol Treatment as Assessed by Interphase Cytogenetics, VH Mutational Status, ZAP-70 Protein Expression, CD38, and p53|overall response rates (CR+PR)|up to 8 months|Data were not collected and analyzed for VH mutational status, ZAP-70 protein expression, CD38, and p53||percentage of patients in each subgroup|||Number
704297|NCT00098371|Secondary|Comparison of CLL Cell Samples Taken at Registration/Diagnosis to CLL Cell Samples Taken at Time of Relapse|Samples will be examined for ex vivo sensitivity to flavopiridol, expression of select anti-apoptosis proteins, BCRP mRNA and protein expression, difference in gene expression by cDNA microarray and potentially by epigenetic arrays. Comparisons will be used to evaluate mechanisms of acquired flavopiridol resistance.|At baseline and at time of relapse or when patient goes off therapy due to disease progression|Data for this outcome as not collected and analyzed|||||
704298|NCT00098371|Secondary|Serial Levels of IL-6 as Assessed by Blood Plasma|IL-6 measures were adjusted for baseline values|4.5 hours, 8 hours, 12 hours, and 24 hours following the initiation of therapy during day 1 of course 1|IL-6 expression analysis was available for only day 1 and not day 8.||pg/ml||95% Confidence Interval|Mean
704299|NCT00098371|Secondary|PK as Assessed by Levels of Both Flavopiridol and Metabolites of Flavopiridol in Urine Samples|urine samples were collected in some patients during the first 24 hours after the start of the infusion on cycle 1, day 1 to isolate metabolites of flavopiridol to be used as internal standard for plasma metabolite quantification experiments.|Urine collected at 4 separate times in some patients during the first 24 hours after start of infusion on day 1 of course 1.|Data for this PK analysis was not collected and analyzed.|||||
704300|NCT00098371|Secondary|PK (Cmax) as Assessed by Plasma Levels of Both Flavopiridol and Metabolites of Flavopiridol|Pharmacokinetics were performed on day 1 and day 8 of cycle 1 by plasma levels of both flavopiridol and metabolites of flavopiridol|During treatment day 1 and day 8 of course 1|The values are overall averages for all patients on days 1 and 8 - therefore, there is only a single value for each parameter.||μM||Standard Deviation|Mean
704301|NCT00098371|Secondary|Pharmacokinetics (PK) (AUC) as Assessed by Plasma Levels of Both Flavopiridol and Metabolites of Flavopiridol|Pharmacokinetics were performed on day 1 and day 8 of cycle 1 by plasma levels of both flavopiridol and metabolites of flavopiridol using Area Under the Curve (AUC)|During treatment day 1 and day 8 of cycle 1|The values are overall averages for all patients on days 1 and 8 - therefore, there is only a single value for each parameter.||μM*hr||Standard Deviation|Mean
704350|NCT00098774|Secondary|4 Year Overall Survival Rate|Percentage of patients who were alive at 4 years. The 4-year survival rate was estimated using the Kaplan Meier method.|4 years|||percentage of participants||95% Confidence Interval|Number
704305|NCT00098371|Primary|Progression-free Survival (PFS) for Responding Patients as Assessed Using Standard Kaplan-Meier Methods|PFS was calculated from the date of study entry until time of disease progression or death, whichever came first, censoring patients alive and relapse free at last follow up. Patients who withdrew from study to undergo an allogeneic SCT (Stem cell transplantation) were censored at the time of transplantation.|Up to 5 years|||months||95% Confidence Interval|Median
704306|NCT00098371|Primary|Response Duration|Response evaluation criteria based on the Revised National Cancer Institute-sponsored Working Group Guidelines for response. Descriptive statistics will be computed (median, range, mean, standard deviation, minimum, and maximum) on response duration.|Up to 8 months|Duration of response was not collected for patients.|||||
704307|NCT00098371|Primary|Overall Response Rate (CR + PR)|CR requires all of the following: Absence of lymphadenopathy in excess of 1 cm on physical exam; No hepatomegaly or splenomegaly on physical exam; Absence of constitutional symptoms; Normal CBC as exhibited by polymorphonuclear leukocytes > 1500/µL, platelets > 100,000/µL, hemoglobin > 11.0 g/dl (untransfused); lymphocyte count < 5,000/µL; Bone marrow aspirate and biopsy must be normocellular for age with < 30% of nucleated cells being lymphocytes. Lymphoid nodules must be absent. Patients with CR after induction but wih treatment-related persistent cytopenia is a PR. PR requires a > 50% decrease in peripheral lymphocyte count from pretreatment value, > 50% reduction in lymphadenopathy, and/or > 50% reduction in splenomegaly/hepatomegaly. These patients must have one of the following: polymorphonuclear leukocytes > 1,500/μL , platelets > 100,000/μL, hemoglobin > 11.0 g/dl (untransfused) or any with 50% improvement from pretreatment value.|Up to 8 months|Schedule was amended (cycle length) from 42 to 28 days, reduction in the number of doses per cycle from 4 to 3 and administration of prophylactic dexamethasone 20 mg IV on each treatment day.||percent of patients||95% Confidence Interval|Number
704308|NCT00098371|Primary|Complete Response (CR) Rate|CR requires all of the following for at least two months from completion of therapy: Absence of lymphadenopathy in excess of 1 cm on physical exam; No hepatomegaly or splenomegaly on physical exam; Absence of constitutional symptoms; Normal CBC (complete blood count) as exhibited by polymorphonuclear leukocytes > 1500/µL, platelets > 100,000/µL, hemoglobin > 11.0 g/dl (untransfused); lymphocyte count < 5,000/µL; Bone marrow aspirate and biopsy must be normocellular for age with < 30% of nucleated cells being lymphocytes. Lymphoid nodules must be absent.|Up to 8 months|Patients were assessed for clinical response after two, four and six cycles.||percent of patients|||Number
704311|NCT00098670|Secondary|Number of Participants With Severe Non-Hematologic Adverse Events During Treatment With Alemtuzumab|"The National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Version 2.0 was used to evaluate toxicity. Severe Adverse events are defined as grade 3, 4 or 5, at least possibly related to treatment.
Grade 1: mild; Grade 2: moderate; Grade 3: Severe; Grade 4: Life Threatening; Grade 5: Death."|6 weeks beginning at study week 36|58 participants were treatment with Alemtuzumab.||participants|||Number
704312|NCT00098670|Secondary|2 Year Survival|Percentage of participants who were alive at 2 years. The 2 year survival was estimated using the Kaplan Meier method.|2 years from registration|||percentage of participants|||Number
704313|NCT00098670|Secondary|2 Year Progression Free Survival|Percentage of patients who were alive and progression free at 2 years. The 2-year progression free survival was estimated using the Kaplan Meier method.|2 years from registration|||percentage of participants|||Number
704314|NCT00098670|Secondary|Number of Participants With a Complete or Partial Response After Induction Therapy With Fludarabine & Rituximab|"Response, as defined by the National Cancer Institute Working Group (NCIWG):
CR: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count; confirmed by bone marrow (BM) aspirate & biopsy
PR: 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence/absence of constitutional symptoms; plus ≥1 of the following: ≥1500/μL polymorphonuclear leukocytes, >100,000/μL platelets, >11.0 g/dL hemoglobin or 50% improvement for these parameters without transfusions"|Up to 9 months|||participants|||Number
704315|NCT00098670|Primary|Number of Participants With a Complete Response After Treatment With Fludarabine & Rituximab Followed by Alemtuzumab|"A complete response, as defined by the National Cancer Institute Working Group (NCIWG):
- CR: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count; confirmed by bone marrow (BM) aspirate & biopsy"|Duration of treatment (up to 13.5 months)|58 participants were treated with Alemtuzumab.||participants|||Number
704316|NCT00098722|Secondary|Change From Baseline in Viral Load at Week 24 and Week 48 by Overall Susceptibility Score (OSS) at Screening|Association between baseline resistance and virological response was assessed as change in viral load by OSS at screening. OSS categorized as 0, 1, 2, >3 (maximum value of 6) and calculated as the sum of the net assessment of in-vitro phenotypic and genotypic susceptibility using a binary scoring system (0= resistant, 1= sensitive or susceptible) for each antiretroviral agent in OBT. Higher scores indicate greater susceptibility. Baseline value is the average of the values from screening, randomization and immediately pre-dose.|Baseline, Week 24 and Week 48|FAS; 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure. 'n' is number of participants with given OSS score at screening for each treatment arm measured at particular time-point. LOCF was used to impute missing values.||log10copies/mL||Standard Deviation|Mean
704317|NCT00098722|Secondary|Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 48|Number of participants per tropism status R5, X4, DM, or NR/NP at baseline and time of failure analyzed through week 48 visit. Treatment failure defined as discontinuation due to insufficient clinical response. HIV-1 RNA viral load <500 copies/ml categorized as BLQ. The assessment for time of treatment failure was defined as the last on treatment assessment.|Baseline and time of failure through Week 48|FAS; 'N' (number of participants analyzed) is signifying those participants who experienced treatment failure, defined as discontinuation due to insufficient response and had tropism assessment at baseline.||participants|||Number
704318|NCT00098722|Secondary|Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 24|Number of participants per tropism status (C-X-C chemokine receptor 5 {CCR5} [R5], C-X-C chemokine receptor type 4 {CXCR4} [X4], Dual/Mixed [DM], or Non-reportable/Non-phenotypable [NR/NP]) at baseline and time of treatment failure analyzed through week 24 visit. Treatment failure defined as discontinuation due to insufficient clinical response. HIV-1 RNA viral load <500 copies/ml categorized as below lower limit of quantification (BLQ). The assessment for time of treatment failure was defined as the last on treatment assessment.|Baseline and time of failure through Week 24|FAS; 'N' (number of participants analyzed) is signifying those participants who experienced treatment failure, defined as discontinuation due to insufficient response and had tropism assessment at baseline.||participants|||Number
704319|NCT00098722|Secondary|Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 48|Number of participants with GSS and PSS were used as surrogates for genotype and phenotype. Genotypic and phenotypic resistance to PIs, NRTIs, NNRTIs were evaluated at screening and time of treatment failure analyzed through Week 48 visit, by Monogram Biosciences PhenoSense GT assay. Score was determined for each drug in OBT, giving 1:drug ‘sensitive'/'susceptible' and 0:'resistant'. GSS and PSS score range:0 to >3. Genotypic enfuvirtide value was used for PSS, no phenotypic enfuvirtide was recorded.|Screening and time of failure through Week 48|FAS; 'N' (number of participants analyzed) is signifying those participants who experienced treatment failure defined as discontinuation due to insufficient response. 'n' is number of participants who were evaluable for the given change in GSS and PSS score for each arm group respectively.||participants|||Number
704320|NCT00098722|Secondary|Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24|Number of participants with GSS and PSS were used as surrogates for genotype and phenotype. Genotypic and phenotypic resistance to PIs, NRTIs, NNRTIs were evaluated at screening and time of treatment failure analyzed through Week 24 visit, by Monogram Biosciences PhenoSense GT assay. Score was determined for each drug in OBT, giving 1:drug ‘sensitive'/'susceptible' and 0:'resistant'. GSS and PSS score range:0 to >3. Genotypic enfuvirtide value was used for PSS, no phenotypic enfuvirtide was recorded.|Screening and time of failure through Week 24|FAS; 'N' (number of participants analyzed) is signifying those participants who experienced treatment failure defined as discontinuation due to insufficient response. 'n' is number of participants who were evaluable for the given change in GSS and PSS score for each arm group respectively.||participants|||Number
704321|NCT00098722|Secondary|Number of Participants With Genotypic Susceptibility Score (GSS) and Phenotypic Susceptibility Score (PSS) at Screening|Number of participants with GSS and PSS were used as surrogates for genotype and phenotype. Genotypic and phenotypic resistance to protease inhibitors(PIs), nucleoside reverse transcriptase inhibitors(NRTIs) and non-nucleoside reverse transcriptase inhibitors(NNRTIs) were evaluated at screening (not at baseline), by Monogram Biosciences PhenoSense genotyping (GT) assay. Score was determined for each drug in OBT, giving 1:drug ‘sensitive'/'susceptible' and 0:'resistant'. GSS and PSS score range:0 to >3. Genotypic enfuvirtide value was used for PSS, no phenotypic enfuvirtide was recorded.|Screening|FAS included all the randomized participants who had taken at least one dose of the study medication.||participants|||Number
704322|NCT00098722|Secondary|Time-Averaged Difference (TAD) From Baseline in log10 Transformed HIV-1 RNA Levels|TAD from baseline was calculated as area under the curve of HIV-1 RNA load (log10 copies/mL) divided by time period minus baseline HIV-1 RNA load (log10 copies/mL). Baseline value calculated as the average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.|Baseline to Week 24 and Week 48|FAS included all the randomized participants who had taken at least one dose of the study medication. Missing data imputed as 0 for participants who discontinued and through last available observation for participants who did not discontinue.||log10 copies/mL||Standard Error|Least Squares Mean
704323|NCT00098722|Secondary|Time to Virological Failure|Time to virologic failure based on observed HIV-1 RNA levels and failure events (death;permanent discontinuation of drug;lost to follow-up[LTFU];new anti-retroviral drug added [except background drug change to drug of same class];or on open label for early non-response or rebound). Failure:at Time 0 if level not <400 copies/mL (2 consecutive visits) before events or last available visit;at time of earliest event if level <400 copies/mL (2 consecutive visits);failure if level >=400 copies/mL (2 consecutive visits) or 1 visit >=400 copies/mL followed by permanent discontinuation of drug or LTFU.|Week 48|FAS included all the randomized participants who had taken at least one dose of the study medication.||days||95% Confidence Interval|Median
704324|NCT00098722|Secondary|Change From Baseline in CD8 Cell Count at Week 24 and 48|Change from baseline in CD8 cell count measured as cells/µL. Baseline value calculated as average of pre-dose measurements collected at screening and immediately pre-dose.|Week 24 and 48|FAS included all the randomized participants who had taken at least one dose of the study medication. 'N' (number of participants analyzed) signifies participants evaluable for this measure. Missing values were imputed using LOCF.||cells/μL||Standard Error|Least Squares Mean
704325|NCT00098722|Secondary|Change From Baseline in CD4 Cell Count at Week 24 and 48|Change from baseline in CD4 cell count measured as cells/µL. Baseline value calculated as average of pre-dose measurements collected at screening and immediately pre-dose.|Week 24 and 48|FAS included all the randomized participants who had taken at least one dose of the study medication. 'N' (number of participants analyzed) signifies participants evaluable for this measure. Missing values were imputed using LOCF.||cells/μL||Standard Error|Least Squares Mean
704326|NCT00098722|Secondary|Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Cell Count at Baseline|Baseline value calculated as average of pre-dose measurements collected at screening and immediately pre-dose.|Baseline|FAS included all the randomized participants who had taken at least one dose of the study medication. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||cells per microliter (cells/μL)||Standard Deviation|Mean
704327|NCT00098722|Secondary|Percentage of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL||Week 24 and 48|"FAS included all the randomized participants who had taken at least one dose of the study medication. Missing data was imputed as failure which was defined as not meeting the criteria of less than 50 copies/mL of HIV-1 RNA levels."||percentage of participants|||Number
704328|NCT00098722|Secondary|Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/ml or With at Least 1.0 log10 Decrease From Baseline||Week 24 and 48|"FAS included all the randomized participants who had taken at least one dose of the study medication. Missing data was imputed as failure which was defined as not meeting the criteria of less than 400 copies/mL or with at least 1.0 log10 decrease from baseline of HIV-1 RNA levels."||percentage of participants|||Number
704329|NCT00098722|Secondary|Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/ml or With at Least 0.5 log10 Decrease From Baseline||Week 24 and 48|"FAS included all the randomized participants who had taken at least one dose of the study medication. Missing data was imputed as failure which was defined as not meeting the criteria of less than 400 copies/mL or with at least 0.5 log10 decrease from baseline of HIV-1 RNA levels."||percentage of participants|||Number
704330|NCT00098722|Secondary|Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/mL||Week 24 and 48|"FAS included all the randomized participants who had taken at least one dose of the study medication. Missing data was imputed as failure which was defined as not meeting the criteria of less than 400 copies/mL of HIV-1 RNA levels."||percentage of participants|||Number
704331|NCT00098722|Primary|Change From Baseline in Log 10-transformed HIV-1 RNA Levels at Week 48|Change from baseline in log 10-transformed plasma viral load (HIV-1 RNA) levels (log10 copies/mL). Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.|Baseline and Week 48|FAS included all the randomized participants who had taken at least one dose of the study medication. Missing values have been imputed as baseline value for the participants who discontinued and as LOCF for participants who did not discontinue.||log10 copies/mL||Standard Error|Least Squares Mean
704332|NCT00098722|Primary|Change From Baseline in Log 10-transformed HIV-1 RNA Levels at Week 24|Change from baseline in log 10-transformed plasma viral load (HIV-1 RNA) levels (log10 copies/mL). Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.|Baseline and Week 24|FAS included all the randomized participants who had taken at least one dose of the study medication. Missing values have been imputed as baseline value for the participants who discontinued and as Last observation carried forward (LOCF) for participants who did not discontinue.||log10 copies/mL||Standard Error|Least Squares Mean
704333|NCT00098722|Primary|Log 10-transformed Human Immunodeficiency Virus Ribonucleic Acid (HIV-1 RNA) Levels at Baseline|Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.|Baseline|Full analysis set (FAS) included all the randomized participants who had taken at least one dose of the study medication.||log10 copies/milliliter(log10 copies/mL)||Standard Deviation|Mean
704334|NCT00098748|Secondary|Number of Subjects With Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Illnesses (Analysis at Week 48)|Number of subjects with AIDS-defining opportunistic illnesses based on investigator classification guided by a predefined list of clinical Category C Adverse Events per CDC HIV Classification System. Includes events occurring up to 7 days after last dose of study drug.|Baseline through Week 48|FAS - as randomized; N=number of subjects with Category C Adverse Events for maraviroc QD, maraviroc BID, and placebo, respectively. Week 48 results reflect subsequent updates to data originally reported at Week 24.||participants|||Number
704335|NCT00098748|Secondary|Number of Subjects With Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Illnesses (Analysis at Week 24)|Number of subjects with AIDS-defining opportunistic illnesses based on investigator classification guided by a predefined list of clinical Category C Adverse Events per Center for Disease Control (CDC) HIV Classification System. Includes events occurring up to 7 days after last dose of study drug.|Baseline through Week 24|FAS - as randomized; N=number of subjects with Category C Adverse Events for maraviroc QD, maraviroc BID, and placebo, respectively. Week 48 results reflect subsequent updates to data originally reported at Week 24.||participants|||Number
704336|NCT00098748|Secondary|Number of Subjects With Treatment Failure at Week 48 by Overall Susceptibility Score (OSS) at Screening|Number of subjects for association between screening resistance and virologic response as determined by treatment failure and OSS at screening. OSS categorized as 0, 1, 2, or ≥3 (maximum value of 6) and calculated as the sum of the net assessment of in vitro phenotypic and genotypic susceptibility using a binary scoring system (0= reduced susceptibility, 1=susceptible) for each antiretroviral agent in OBT. Higher scores indicate greater susceptibility.|Screening, Week48|FAS - as treated dual-tropic subjects. Missing values imputed as LOCF.||particpants|||Number
704337|NCT00098748|Secondary|Number of Subjects With Treatment Failure at Week 24 by Overall Susceptibility Score (OSS) at Screening|Number of subjects for association between screening resistance and virologic response as determined by treatment failure and OSS at screening. OSS categorized as 0-1, 2-4, >4 (maximum value of 6) and calculated as the sum of the net assessment of in vitro phenotypic and genotypic susceptibility using a binary scoring system (0= reduced susceptibility, 1=susceptible) for each antiretroviral agent in OBT. Higher scores indicate greater susceptibility.|Screening, Week 24|FAS - as treated dual-tropic subjects. Missing values imputed as LOCF.||participants|||Number
704367|NCT00098956|Secondary|Progression-free Survival||From the date of enrollment to progression, death or last contact, or last tumor assessment before the start of further anti-tumor therapy, assessed up to 5 years||||||
704338|NCT00098748|Secondary|Number of Subjects Per Tropism Status at Screening and Time of Treatment Failure (Analysis at Week 48)|Number of subjects per Tropism status (CCR5 [R5], CXCR4 [X4], Dual Mixed [DM], or Non-reportable/Non-phenotypable [NR/NP]) at Screening (Scr) and at time of treatment failure (Tx fail). Treatment failure defined as insufficient clinical response. HIV-1 RNA viral load <500 copies/ml categorized as below lower limit of quantification (BLQ). Tropism may have been assessed at either the Screening or Baseline visit. The assessment for time of treatment failure is defined as the last on-treatment assessment.|Screening through Week 48|FAS-as treated; N=subjects with TX failure due to insufficient clinical response and who had a tropism assessment at Screening. Subjects with DC prior to timepoint not included; LOCF if no result (viral load too low for analysis).||participants|||Number
704339|NCT00098748|Secondary|Number of Subjects Per Tropism Status at Screening and at the Time of Treatment Failure (Analysis at Week 24)|Number of subjects per Tropism status (CCR5 [R5], CXCR4 [X4], Dual Mixed [DM], or Non-reportable/Non-phenotypable [NR/NP]) at Screening (Scr) and at time of treatment failure (Tx fail). Treatment failure defined as insufficient clinical response. HIV-1 RNA viral load <500 copies/ml categorized as below lower limit of quantification (BLQ). Tropism may have been assessed at either the Screening or Baseline visit. The assessment for time of treatment failure is defined as the last on-treatment assessment.|Screening through Week 24|FAS-as treated; N=subjects with TX failure due to insufficient clinical response and who had a tropism assessment at Screening. Subjects with DC prior to timepoint not included; LOCF if no result (viral load too low for analysis).||participants|||Number
704340|NCT00098748|Secondary|Number of Subjects Per Genotype and Phenotype at Baseline and at Time of Failure|Number of subjects per genotype and phenotype (tests for presence of non CCR5-tropic HIV-1 and for resistance to reverse transcriptase, protease, and fusion inhibitors) at baseline and at time of failure through Week 48 visit. Sensitivity to drug categorized as 0-1, 2-4, >4; scores defined as 0=resistance, 1=sensitive or susceptible with higher number indicating greater sensitivity or susceptibility.|Baseline through Week 48|FAS-as treated dual-tropic subjects. Genotype and phenotype at screening and at time of failure were not summarized as planned.||participants|||Number
704341|NCT00098748|Secondary|Change From Baseline in Time Averaged Difference (TAD) in log10 HIV-1 RNA|Change from baseline of TAD in log10 HIV-1 RNA viral load calculated as [AUC of HIV-1 RNA viral load (log10 copies/mL) / time period] - Baseline HIV-1 RNA viral load (log10 copies/mL). Baseline value calculated as the average of pre-dose measurements collected at screening, randomization, and baseline visits.|Baseline to Week 24 and Week 48|FAS - as treated dual-tropic subjects. Discontinuations prior to time point of analysis imputed as 0.||log10 copies/mL||Standard Error|Mean
704342|NCT00098748|Secondary|Time (50% Quartile Point Estimate) to Virologic Failure|Time to virologic failure based on observed HIV-1 RNA levels and failure events (death; permanent discontinuation of test drug [perm DC]; lost to follow-up [LTFU]; new anti-retroviral drug added (except background drug change to drug of same class); or on open label for early non-response or rebound). Failure: at Time 0 if level not <400 copies/mL (2 consecutive visits) before event(s) or last available visit; at time of earliest event if level <400 copies/mL (on 2 consecutive visits); failure if level ≥400 copies/mL (2 consecutive visits) or 1 visit ≥400 copies/mL followed by perm DC or LTFU.|Day 1 through Week 24 and through Week 48|FAS - as treated dual-tropic subjects; (n)=number of subjects with virologic failure at observation for maraviroc QD, maraviroc BID, and placebo, respectively; Week 48 result values (0.00)=virologic failure at Day 0.||days||95% Confidence Interval|Median
704343|NCT00098748|Secondary|Change From Baseline in CD8 Cell Count|Change from baseline in CD8 cell count (measured as cells/µL). Baseline value calculated as the average of pre-dose measurements collected at screening, randomization, and baseline visits.|Baseline to Week 24 and Week 48|FAS - as treated dual-tropic subjects. Placebo N: 4 subjects did not have on-treatment information. Missing data imputed using LOCF.||cells/µL||Standard Error|Mean
704344|NCT00098748|Secondary|Change From Baseline in CD4 Cell Count|Change from baseline in CD4 cell count (measured as cells per microliter [cells/µL]). Baseline value calculated as the average of pre-dose measurements collected at screening, randomization, and baseline visits.|Baseline to Week 24 and Week 48|FAS - as treated dual-tropic subjects. Placebo N: 4 subjects did not have on-treatment information. Missing data imputed using LOCF.||cells/µL||Standard Error|Mean
704345|NCT00098748|Secondary|Number of Subjects With HIV-1 RNA Levels < 50 Copies/mL||Baseline, Week 24, Week 48|FAS - as treated dual-tropic subjects. Missing values counted as failures/non-responders (counted as not achieving the stated criterion).||participants|||Number
704346|NCT00098748|Secondary|Number of Subjects With HIV-1 RNA Levels < 400 Copies/mL or at Least 1.0 Log 10-transformed Decrease From Baseline in HIV-1 RNA Levels|Number of subjects with HIV-1 RNA levels < 400 copies/mL or at least 1.0 log 10-transformed decrease from baseline in HIV-1 RNA levels. Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and baseline visits.|Baseline, Week 24, Week 48|FAS-as treated dual-tropic subjects. Missing values counted as failures/non-responders (counted as not achieving the stated criterion).||participants|||Number
704347|NCT00098748|Secondary|Number of Subjects With HIV-1 RNA Levels < 400 Copies/mL or at Least 0.5 Log 10-transformed Decrease From Baseline in HIV-1 RNA Levels|Number of subjects with HIV-1 RNA levels < 400 copies/mL or at least 0.5 log 10-transformed decrease from baseline in HIV-1 RNA levels. Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and baseline visits.|Baseline, Week 24, Week 48|FAS-as treated dual-tropic subjects. Missing values counted as failures/non-responders (counted as not achieving the stated criterion).||participants|||Number
704348|NCT00098748|Secondary|Number of Subjects With HIV-1 RNA Levels < 400 Copies/mL||Week 24, Week 48|FAS - as treated dual-tropic subjects. Missing values counted as failures/non-responders (counted as not achieving the stated criterion).||participants|||Number
704349|NCT00098748|Primary|Change From Baseline in Human Immunodeficiency Virus (HIV-1) Viral Load (Ribonucleic Acid [RNA])|Change from baseline in log 10-transformed plasma viral load (HIV-1 RNA) levels (log 10 copies per milliliter [log10 copies/mL]). Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and baseline visits.|Baseline to Week 24 and Week 48|Full Analysis Set (FAS)-as treated: all randomized subjects classified as dual-tropic by phenotype assay; received at least 1 dose of study treatment. Missing values: discontinuations (DC) imputed as baseline value (change from baseline=0); missing data imputed as Last Observation Carried Forward (LOCF).||log10 copies/mL||Standard Error|Mean
704351|NCT00098774|Secondary|Change From Baseline in Mini-Mental Status Evaluation at 4 Months|Neurologic functioning will be assessed using the Mini-Mental Status Evaluation (MMSE), a standardized, bedside tool for evaluation of higher mental function. This assessment is based on a 30-point scale (0-30) with higher scores associated with better performance.|Baseline & month 4|Only 14 participants had both baseline and 4 month MMSE evaluations reported.||units on a scale||Full Range|Median
704352|NCT00098774|Secondary|4 Year Progression Free Rate|"Percentage of patients who were progression free at 4 years. The 4-year progression free rate was estimated using the Kaplan Meier method.
Relapse was assessed by investigator according to Revised Response Criteria for Malignant Lymphoma. Progression required a 25% increase of previous area of gadolinium enhancement, appearance of new areas of T1 gadolinium enhancement or new appearance of malignant cells in the spinal fluid or new tumor appearance in other sites of the body"|4 years|||percentage of participants||95% Confidence Interval|Number
704353|NCT00098774|Primary|Complete Response Rate After Remission Induction|Response is assessed by investigator according to Revised Response Criteria for Malignant Lymphoma. Complete response requires disappearance of all evidence of disease.|4 months|||percentage of participants||95% Confidence Interval|Number
704354|NCT00098787|Secondary|Overall Survival (OS)|Overall survival is defined as time from randomization (to Arm A or Arm B) or registration (to Arm C) to death. Patients alive at last follow-up were censored.|Assessed every 3 months if the patient is within 2 years of registration and every 6 months once the patient is 2-4 years post-registration.|Eligible and treated patients||months||95% Confidence Interval|Median
704355|NCT00098787|Secondary|Progression-Free Survival (PFS)|Progression-free survival is defined as time from randomization (to Arm A or Arm B) or registration (to Arm C) to the earlier of disease progression or death. Patients alive and progression-free at last follow-up were censored.|Assessed every 3 months if the patient is within 2 years of registration and every 6 months once the patient is 2-4 years post-registration.|Eligible and treated patients||months||95% Confidence Interval|Median
704356|NCT00098787|Primary|Objective Response Rate|Objective response rate is defined as proportion of patients who achieve complete response (CR) or partial response (PR). Response was assessed using Solid Tumor Response Criteria (RECIST). CR is defined as the disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter.|Assessed every 3 months if the patient is within 2 years of registration and every 6 months up to 4 years post-registration.|Eligible and treated patients||proportion||90% Confidence Interval|Number
704357|NCT00098813|Primary|Tumor Major Response Rate (Including Stable Disease) as Measured by RECIST Criteria||From start of treatment to 8 weeks|||participants|||Number
704358|NCT00098839|Secondary|Pharmacokinetics|Determined along with the mean, median, standard deviation and range of the parameters of interest. Statistical analysis will be purely descriptive.|Up to day 36||||||
704359|NCT00098839|Primary|Rate of Minimal Residual Disease (MRD) < 0.01%|Proportion of patients (evaluable and had MRD measured at the end of Block 1) who had MRD < 0.01%.|At the end of Block 1 of re-induction therapy (day 36)|Evaluable patients who had MRD measured at the end of Block 1. There were 2 ineligible patients for once weekly arm and 13 patients where MRD was not measured at the end of block 1 re-induction therapy. There were 16 patients for twice weekly arm where MRD was not measured at the end of block 1 re-induction therapy.||Proportion of participants|||Number
704360|NCT00098839|Primary|Event-free Survival Rate|Proportion of patients who were event free at 4 months|At 4 months after enrollment|Evaluable patients at the end of Block 1. There were 2 ineligible patients for once weekly arm and 6 patients not evaluable at the end of block 1 re-induction therapy. There were 10 patients for twice weekly arm not evaluable at the end of block 1 re-induction therapy.||Proportion of participants|||Number
704361|NCT00098839|Primary|Remission Re-induction (CR2) Rate|The proportion of patients who achieved complete response at the end Block 1 of re-induction therapy. Complete Remission (CR) - Attainment of M1 bone marrow (<5% blasts) with no evidence of circulating blasts or extramedullary disease and with recovery of peripheral counts (ANC >1000/uL and platelet count >100,000/uL). Partial Remission (PR) - Complete disappearance of circulating blasts and achievement of M2 marrow status (5% or < 25% blast cells and adequate cellularity). Partial Remission Cytolytic (PRCL) - Complete disappearance of circulating blasts and achievement of at least 50% reduction from baseline in bone marrow blast count. Minimal Response Cytolytic (MRCL) - 50% reduction in the peripheral blast count with no increase in peripheral white blood cell count.|At the end of Block 1 of re-induction therapy (day 36)|Evaluable patients at the end of Block 1. There were 2 ineligible patients for once weekly arm and 6 patients not evaluable at the end of block 1 re-induction therapy. There were 10 patients for twice weekly arm not evaluable at the end of block 1 re-induction therapy.||proportion of participants|||Number
704362|NCT00098865|Secondary|Overall Survival|Time from registration to death. Patients alive at last follow-up were censored.|Assessed after treatment discontinued every 3 months up to 2 years.|The analysis dataset is comprised of all treated patients.||months||95% Confidence Interval|Median
704363|NCT00098865|Secondary|Overall Response|"Overall response is the best response during 6 months of therapy measured by radiographic response.
Complete Response (CR): Disappearance of all detectable tumors by imaging, if initially positive, as well as 2 consecutively negative CSF cytologic examinations (if the initial cytology was positive).
Partial Response (PR): > 50% reduction in the sum of the products of the maximum perpendicular diameter of all measurable lesions; or 2 consecutively negative CSF cytologies and a < 50% reduction in tumor size.
Stable Disease (SD): < 50% reduction in the sum of the products of the maximum perpendicular diameters of all measurable lesions, and persistently negative or positive CSF cytology Progressive Disease (PD): > 25% increase in the size of any measurable lesion, the appearance of a new radiographically demonstrable lesion, or the conversion of negative CSF cytology to positive, as confirmed by at least one repeat CSF cytology"|Assessed every 8 weeks while on treatment and every 3 months for one year off-study|||participants|||Number
704364|NCT00098865|Primary|Therapy Completion Rate|Feasibility in this study was defined as completion of 6 months of thalidomide with temozolomide therapy. The corresponding therapy completion rate is defined as the proportion of patients who completed 6 months of therapy.|6 months|The analysis dataset is comprised of all treated patients.||proportion of participants||90% Confidence Interval|Number
704365|NCT00098956|Secondary|Adverse Events, Graded Using the CTCAE Version 3.0||Up to 5 years||||||
704366|NCT00098956|Secondary|Overall Survival||From the date of enrollment to death or last contact, assessed up to 5 years||||||
704380|NCT00099021|Secondary|Patients' Histological (Tissue) Response|Determined by biopsy results before and 4 weeks after treatment: Complete Response (CR) =complete reversal of dysplasia or hyperplasia, Partial Response (PR) = >or=50% decrease in sum of lesions, no increase in 1 or more lesions and no new lesion occurs, Stable Disease (SD0 = not CR, PR or Progressive Disease (PD), PD = >or= 25% increase in sum of lesions or new lesion or progression to invasive carcinoma.|Week 16 (4 weeks post dose)|||Participants|||Number
704381|NCT00099021|Secondary|Patients' Clinical Response|Determined by measurement of lesions- Complete Response (CR)= disappearance of all lesions, Partial Response (PR)= >or= 50% decrease in sum of lesions, Stable Disease (SD) = does not meet CR,PR or Progressive Disease (PD), and PD= >or= 25% increase in sum of lesions|Week 16 (4 weeks post dose)|||Participants|||Number
704382|NCT00099021|Primary|Patients' Overall Response|"Overall Response= reviewing both the clinical and histological responses and assigning the worst category.
Complete Response (CR) = Clinical CR and Histologic CR, or Histologic CR Partial Response (PR) = Clinical CR or PR and Histologic PR or Stable Disease (SD) Stable Disease (SD) = Clinical SD and Histologic PR or SD Progressive Disease (PD) = Clinical PD and/or Histologic PD"|Week 16 (4 weeks post dose)|||Participants|||Number
704383|NCT00099047|Primary|Changes in M-protein Levels|For a given biomarker (or a suitable transformation of it, e.g. log transform) t-tests and Wilcoxon tests (2-sample t-test and Wilcoxon rank sum test for between treatment comparisons, and paired 1-sample t-test and Wilcoxon signed rank test for within treatment comparisons) will be used to detect statistically significant differences between (or within) treatments.|Baseline and 6 months|One patient on the celecoxib arm was considered inevaluable and not included in this participants analyzed.||g/dL||Standard Deviation|Median
704384|NCT00099268|Secondary|Change From Baseline in Health-related Quality of Life Assessed Using the 39-item Parkinson's Disease Questionnaire (PDQ-39)|The PDQ-39 instrument is used to assess quality of life in individuals with Parkinson’s disease. The questionnaire provides scores on eight scales: Mobility, activities of daily living, emotions, stigma, social support, cognition, communication, and bodily discomfort. Questions are scored on a 5-point Likert scale ranging from 1 (never) to 3 (sometimes) to 5 (always). The total score can range from 39 to 190. A lower score indicates better quality of life. A negative change score indicates an improvement.|Baseline to Week 156|The intent to treat (ITT) population consisted of all patients randomized who received at least one dose of study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned at randomization.||Units on a scale||Standard Deviation|Mean
704385|NCT00099268|Secondary|Occurrence of Dyskinesia|Dyskinesia was assessed by a blinded rater at each visit. Time to dyskinesia was defined as the visit at which the rater first answered “yes” to the following question: “In your opinion, does this patient have dyskinesia?”|Baseline to Week 208|The intent to treat (ITT) population consisted of all patients randomized who received at least one dose of study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned at randomization. Subjects who discontinued from treatment before 134 weeks without dyskinesia were excluded.||Participants|||Number
704386|NCT00099268|Secondary|Time to First Occurrence of Wearing-off|Wearing off is defined as a perception of loss of mobility or dexterity, usually taking place gradually over minutes (up to an hour) and usually bearing a close temporal relationship to the timing of anti-parkinsonian medications; it does not include early-morning akinesia. To ascertain its occurrence, a blinded rater questioned the patient whether he/she had noticed that the benefits of the study drug wear-off. A motor complications and patient questionnaire card were provided to assist the blinded rater in determining whether a patient had experienced wearing-off.|Baseline to end of study (134-208 weeks of treatment)|The intent to treat (ITT) population consisted of all patients randomized who received at least one dose of study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned at randomization.||Weeks||Standard Error|Mean
704387|NCT00099268|Secondary|Occurrence of Wearing-off|Wearing-off is defined as a perception of loss of mobility or dexterity, usually taking place gradually over minutes (up to an hour) and usually bearing a close temporal relationship to the timing of anti-parkinsonian medications; it does not include early-morning akinesia. To ascertain its occurrence, a blinded rater questioned the patient as to whether he/she had noticed that the benefits of the study drug were wearing-off.|Baseline to Week 134|The intent to treat (ITT) population consisted of all patients randomized who received at least one dose of study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned at randomization. Subjects who discontinued treatment before 134 weeks without wearing-off were excluded.||Participants|||Number
704388|NCT00099268|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score (Parts II and III)|The UPDRS is a standardized assessment scale used to measure the patient’s disease state. It was to be completed by a blinded rater. There are 6 parts to the UPDRS. Part II (items 5-17; total score 0-52 units on the scale) measures the patient’s activities of daily living and part III (items 18-31; total score 0-56 units on the scale) measures the motor function of the patient. The total score ranges from 0 to 108 units on the scale. A higher score indicates greater disability. A negative change score indicates improvement.|Baseline, Week 6 and Week 130|The intent to treat (ITT) population consisted of all patients randomized who received at least one dose of study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned at randomization.||Units on a scale||Standard Deviation|Mean
704389|NCT00099268|Primary|Time to First Occurrence of Dyskinesia|Dyskinesia was assessed by a blinded rater at each visit. Time to dyskinesia was defined as the visit at which the rater first answered “yes” to the following question: “In your opinion, does this patient have dyskinesia?” Time to dyskinesia was estimated by Kaplan-Meier product limit estimate that takes into consideration patients who did not experience dyskinesia by censoring them at the end of the study.|Treatment duration for an individual patient varied between a minimum of 134 weeks for those patients recruited last and a maximum of 208 weeks for those patients recruited first|The intent to treat (ITT) population consisted of all patients randomized who received at least one dose of study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned at randomization.||weeks||95% Confidence Interval|Number
704390|NCT00099359|Secondary|NVP Pharmacokinetics|Descriptive study of NVP pharmacokinetics during first two weeks of life using weight band dosing in a subset of enrolled infants.|14 days|||ng/mL||Full Range|Median
704391|NCT00099359|Secondary|Risk Factors for Perinatal HIV-1 Transmission|Risk factors to be assessed include maternal HIV-1 RNA levels at delivery, maternal syphilis and other infections, obstetrical factors such as duration of membrane rupture, and adherence to neonatal medication.|through age 3 months|All available demographic and clinical variables were tested for association with transmission rate. All variables that were significant at p ≤ 0.20 were included in the multivariable regression model. Variables that were not significant were then removed from the model. The backward elimination method was used to select the final model.||participants|||Number
704392|NCT00099359|Secondary|3TC and NFV Pharmacokinetics|Descriptive study of 3TC and NFV pharmacokinetics during first two weeks of life using weight band dosing regimen in a subset of enrolled infants.|through age 14 days|This was a descriptive study. A total of 26 infants were analyzed with 14 at age 4-7 days and 12 at 10-14 days.Plasma samples were collected prior to first AM dose and then at 1,2,4,8 and 12 hours.||ug*h/mL||Full Range|Median
704393|NCT00099359|Secondary|Clinical Covariates of HIV-1 Infection|Compare HIV-1 RNA levels; CD4+ lymphocyte counts; and rates of genotypic and phenotypic resistance among the three treatment regimens.|through age 3 months||||||
704394|NCT00099359|Secondary|Participant Deaths||through age 6 months|||participants|||Number
704395|NCT00099359|Secondary|Infant HIV-1 Infection Status|In utero HIV-1 infection rate|birth|||participants|||Number
704396|NCT00099359|Primary|Participants With Serious Adverse Events|Serious Adverse Events by System Organ Class=Blood and lymphatic system disorders|through age 6 months.|||participants|||Number
704397|NCT00099359|Primary|Infant HIV Infection Status|Intrapartum HIV infection at 3 Months|3 months|All infants with HIV-1 test results except infants infected at birth (i.e. in utero infections) were included in these analysis.||participants|||Number
704398|NCT00099437|Secondary|Overall Survival (OS) - Follow-up|Overall Survival is equivalent to time to death. For this endpoint, all deaths occurring during the study as a whole until the data cut-off for the survival extension (31st October 2011) are presented (analysis at 75% deaths)|Median time (in months) from randomisation until death (from any cause),up to 80 months|All randomised patients||months||Full Range|Median
704399|NCT00099437|Secondary|Change From Randomisation in Trial Outcome Index (TOI) Over the Course of the Study|Mean (and standard deviation) change from randomisation until treatment discontinuation in TOI (defined as the first visit response of 'worsened' which is a decrease in TOI from baseline of 5 points or more) using the Kaplan-Meier method. If a subject has not shown a reduction of 5 points or more at the time of analysis then the observation will be right censored using the last QOL assessment date. Trial Outcome Index (TOI) is derived from the FACT-B questionnaire (Cella et al, 1993) by adding together the scores from the following 3 subscales; Physical well-being (PWB), Functional well-being (FWB) and Breast cancer subscale (BCS). The TOI score range is 0-92 with the higher scores representing the more favourable outcomes. Data were collected from a subgroup of patients.|TOI questionnaires were completed every 4 weeks from randomisation until week 24 and then again at treatment discontinuation, for study duration (48 months)|||Scores on a scale||Standard Deviation|Mean
704400|NCT00099437|Secondary|Overall Survival (OS)|Median time (in months) from randomisation until death (from any cause) (analysis at 50% deaths )|Overall Survival is equivalent to time to death. For this endpoint, all deaths occurring for study duration (48 months)|All patients with measurable disease at baseline.||Time (in months)||Full Range|Median
704401|NCT00099437|Secondary|Duration of Clinical Benefit (DoCB)|Time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who achieve a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) >=24 weeks|RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)|||Time (in months)||Full Range|Median
704402|NCT00099437|Secondary|Duration of Response (DoR)|Time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who achieve a confirmed complete response (CR) or confirmed partial response (PR)|RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)|||Time (in months)||Full Range|Median
704403|NCT00099437|Secondary|Clinical Benefit Rate (CBR)|A Clinical Benefit (CB) responder is defined as a patient having a best overall response of CR, PR or SD (stable disease) >=24 weeks. The Clinical Benefit Rate is the percentage of patients with CB.|Clinical Benefit from the sequence of RECIST scan data for study duration (48 months) . RECIST (Response Evaluation Criteria in Solid Tumours) scans were performed every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)|||Percentage of patients|||Number
704404|NCT00099437|Secondary|Objective Response Rate (ORR)|Using the RECIST scan data, an objective response (OR) is defined as a patient having a best overall response of either complete response (CR) or partial response (PR) which is subsequently confirmed as per RECIST. ORR is defined as the percentage of patients with OR.|RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)|All patients with measurable disease at baseline.||Percentage of patients|||Number
704405|NCT00099437|Primary|Time to Progression (TTP)|Median time (in months) from randomisation until objective disease progression or death (in the absence of objective progression).|RECIST(Response Evaluation Criteria in Solid Tumors ) tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)|||months||Full Range|Median
704406|NCT00099632|Secondary|Number of Participants Who Discontinued Study Treatment Prematurely|participants assigned to 7-day treatment arm and 21-day treatment arm were supposed to stay in study treatment for 7 days and 21 days respectively.|From first day of study treatment to last day of study treatment (up to 21 days)|||participants|||Number
704407|NCT00099632|Secondary|Severe (Grade 3) and Higher Adverse Events and Any Grade Adverse Event That Leads to a Treatment Change From First Day of Study Treatment to Week 12|"Grade 3 or higher signs and symptoms, laboratory abnormalities, events that are reported through the EAE system, and any grade event that leads to a treatment change from first day of study treatment to week 12.
Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death"|From first day of study treatment to week 12|||participants|||Number
704408|NCT00099632|Secondary|Number of Participants With New PI-resistant Variants as Detected by Standard Composite (Bulk) Genotyping.|For the 7-day treatment duration group, only the genotype results from weeks 3 and 7 contributed; For the 21-day treatment duration groups, only the genotype results from weeks 5 and 9 contributed.|2 and 6 weeks after completion of treatment|||participants|||Number
704409|NCT00099632|Secondary|Number of Participants With New Circulating NRTI-resistant Variants Detected by Standard Composite (Bulk) Genotyping.|For the 7-day treatment duration group, only the genotype results from weeks 3 and 7 contributed; For the 21-day treatment duration groups, only the genotype results from weeks 5 and 9 contributed.|2 and 6 weeks after completion of treatment|||participants|||Number
704410|NCT00099632|Primary|Number of Participants With New Circulating Nonnucleoside Reverse Transcriptase Inhibitor (NNRTI)-Resistant Variants as Detected by Standard Composite (Bulk) Genotyping|"For the 7-day treatment duration group, only the genotype results from weeks 3 and 7 contributed to the primary endpoint; For the 21-day treatment duration groups, only the genotype results from weeks 5 and 9 contributed to primary endpoint.
10 participants who did not have resistance samples available were excluded from the primary endpoint analysis."|2 and 6 weeks after completion of treatment|412 women with primary endpoint results available||participants|||Number
704411|NCT00099983|Primary|Change in CAPS Score From Baseline to Week 24|The primary outcome measure for this study was the total score on the 34-item Clinician-Administered PTSD Scale (CAPS). This study was the intent-to-treat analysis of the improvement in PTSD symptoms from baseline to week-24 follow-up as measured by the CAPS. Total score range for the CAPS is 0-136 with higher values representing a worse outcome. This study was powered initially to detect a 9-point difference between the treatment groups in the CAPS change score.|24 Weeks|||units on a scale||95% Confidence Interval|Least Squares Mean
704412|NCT00100048|Other Pre-specified|Number of Patients That Discontinued With LAEs||48 Weeks|The analysis population is based upon the All Patients As Treated (APaT) approach.||participants|||Number
704413|NCT00100048|Secondary|Change From Baseline in CD4 (T-helper) Cell Count at Week 240|Change in number of CD4 cells/mm^3 from baseline to Week 240.|Baseline and Week 240|Modified-Intention-to-Treat (MITT): participants were included in the treatment group to which they were randomized, regardless of adherence to the entry criteria, treatment actually received, and deviation from the protocol. Participants who were randomized but never dosed were not included in the analyses.||cells/mm^3||95% Confidence Interval|Mean
704414|NCT00100048|Secondary|Change From Baseline in Plasma HIV RNA at Week 240|HIV RNA levels were determined by AMPLICOR HIV-1 Monitor™ Standard Assay.|Baseline and Week 240|Modified-Intention-to-Treat (MITT): participants were included in the treatment group to which they were randomized, regardless of adherence to the entry criteria, treatment actually received, and deviation from the protocol. Participants who were randomized but never dosed were not included in the analyses.||Log10Copies/mL||95% Confidence Interval|Mean
704415|NCT00100048|Secondary|Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 240|HIV RNA levels were determined by AMPLICOR HIV-1 Monitor™ Standard Assay.|Week 240|Modified-Intention-to-Treat (MITT): participants were included in the treatment group to which they were randomized, regardless of adherence to the entry criteria, treatment actually received, and deviation from the protocol. Participants who were randomized but never dosed were not included in the analyses.||Participants|||Number
704416|NCT00100048|Secondary|Change From Baseline in CD4 Cell Count at Week 96||Baseline and Week 96|The analysis population is based upon the modified intent to treat (MITT) approach, where patients are included in the treatment group to which they were randomized. Patients who were randomized but never dosed are not included in the analysis. All patients switched to MK0518 400 mg b.i.d post 48 weeks.||cells/mm3||95% Confidence Interval|Mean
704417|NCT00100048|Secondary|Change From Baseline in Plasma HIV RNA at Week 96||Baseline and Week 96|The analysis population is based upon the modified intent to treat (MITT) approach, where patients are included in the treatment group to which they were randomized. Patients who were randomized but never dosed are not included in the analysis. All patients switched to MK0518 400 mg b.i.d post 48 weeks.||copies/mL||95% Confidence Interval|Mean
704418|NCT00100048|Secondary|Number of Patients With HIV RNA Level Below 50 Copies/mL and HIV RNA Level Below 400 Copies/mL at Week 96||96 Weeks|The analysis population is based upon the modified intent to treat (MITT) approach, where patients are included in the treatment group to which they were randomized. Patients who were randomized but never dosed are not included in the analysis. All patients switched to MK0518 400 mg b.i.d post 48 weeks.||participants|||Number
704419|NCT00100048|Secondary|Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 24 (Cohort II)|Mean change from baseline at Week 24 in CD4 Cell Count (cells/mm3)|Baseline and Week 24|The analysis population is based upon the modified intent to treat (MITT) approach, where patients are included in the treatment group to which they were randomized. Patients who were randomized but never dosed are not included in the analysis.||cells/mm3||95% Confidence Interval|Mean
704420|NCT00100048|Secondary|Change From Baseline in Plasma HIV RNA at Week 24 (Cohort II)|Mean change from baseline at Week 24 in plasma HIV RNA (copies/mL)|Baseline and Week 24|The analysis population is based upon the modified intent to treat (MITT) approach, where patients are included in the treatment group to which they were randomized. Patients who were randomized but never dosed are not included in the analysis.||copies/mL||95% Confidence Interval|Mean
704421|NCT00100048|Primary|Number of Participants With HIV RNA (Human Immunodeficiency Virus Ribonucleic Acid) Levels Below 50 Copies/mL at Week 240|HIV RNA levels were determined by AMPLICOR HIV-1 Monitor™ UltraSensitive Assay.|Week 240|Modified-Intention-to-Treat (MITT): participants were included in the treatment group to which they were randomized, regardless of adherence to the entry criteria, treatment actually received, and deviation from the protocol. Participants who were randomized but never dosed were not included in the analyses.||Participants|||Number
704422|NCT00100048|Primary|Number of Participants With Clinical Adverse Experiences (AEs)and Serious Adverse Experiences (SAEs)|"An AE was defined as any unfavorable & unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to its use. Any worsening of a preexisting condition which was temporally associated with the use of the study drug, was also an AE.
A SAE was any AE that resulted in death, was life threatening, resulted in a persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was cancer, or was an overdose."|Week 240|The analysis population was based upon the All Patients As Treated (APaT) approach.||Participants|||Number
704423|NCT00100048|Secondary|Number of Participants With HIV RNA Levels Below 50 Copies/mL at Week 24 (Cohort II)||Week 24|The analysis population is based upon the modified intent to treat (MITT) approach, where patients are included in the treatment group to which they were randomized. Patients who were randomized but never dosed are not included in the analysis.||participants|||Number
704424|NCT00100048|Primary|Number of Patients With Serious CAEs and Non-serious CAEs at Week 144|"An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product
An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product"|144 Weeks|The analysis population is based upon the All Patients As Treated (APaT) approach.||participants|||Number
704425|NCT00100048|Primary|Number of Patients With Serious CAEs (Cohort I and II Combined)|Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose|48 weeks|The analysis population is based upon the All Patients As Treated (APaT) approach.||participants|||Number
704426|NCT00100048|Other Pre-specified|Number of Patients With Serious Drug-related LAEs|Serious LAEs are any LAEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose|48 Weeks|The analysis population is based upon the All Patients As Treated (APaT) approach.||participants|||Number
704427|NCT00100048|Other Pre-specified|Number of Patients With Drug-related LAEs|Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs|48 Weeks|The analysis population is based upon the All Patients As Treated (APaT) approach.||participants|||Number
704428|NCT00100048|Other Pre-specified|Number of Patients With Serious LAEs|Serious LAEs are any LAEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose|48 Weeks|The analysis population is based upon the All Patients As Treated (APaT) approach.||participants|||Number
704429|NCT00100048|Other Pre-specified|Number of Patients With Laboratory Adverse Experiences (LAEs)|A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|48 Weeks|"The analysis population is based upon the All
Patients As Treated (APaT) approach."||participants|||Number
704430|NCT00100048|Other Pre-specified|Number of Patients That Discontinued With CAEs||48 Weeks|The analysis population is based upon the All Patients As Treated (APaT) approach.||participants|||Number
704431|NCT00100048|Other Pre-specified|Number of Patients With Serious Drug-related CAEs|Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose. Drug-related are as assessed by an investigator who is a qualified physician according to his/her best clinical judgment.|48 Weeks|The analysis population is based upon the All Patients As Treated (APaT) approach||participants|||Number
704432|NCT00100048|Other Pre-specified|Number of Patients With Drug-related CAEs|Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs|48 weeks|The analysis population is based upon the All Patients As Treated (APaT) approach.||participants|||Number
704433|NCT00100048|Other Pre-specified|Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 48||48 weeks|The analysis population is based upon the modified intent to treat (MITT) approach, where patients are included in the treatment group to which they were randomized. Patients who were randomized but never dosed are not included in the analysis.||participants|||Number
704434|NCT00100048|Primary|Number of Patients With Clinical Adverse Experiences (CAEs)|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product.|48 weeks|The analysis population is based upon the All Patients As Treated (APaT) approach.||participants|||Number
704435|NCT00100048|Primary|Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 24 (Cohort II)||Week 24|"The analysis population is based upon the modified intent to treat (MITT) approach, where patients are included in the treatment group to which they were randomized. Patients who were randomized but never dosed are not included in the analysis.
All patients who took study medication and had HIV RNA tests performed were included in the analysis."||participants|||Number
704436|NCT00100048|Primary|Number of Patients With Clinical Adverse Experiences (CAEs) and Number of Patients With Serious CAEs at Day 10 (Cohort I)|"An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product.
Serious CAEs are any AEs occurring at any dose that; Results
in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or
prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an
overdose."|10 days|The analysis population is based upon the All Patients As Treated (APaT) approach.||participants|||Number
704437|NCT00100048|Primary|Change From Baseline in Plasma Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) on Day 10 (Cohort I)|Mean change from baseline on Day 10 in plasma Human Immunodeficiency Virus (HIV) Ribonucleic acid (RNA) (copies/mL)|Baseline and Day 10|The analysis population is based upon the modified intent to treat (MITT) approach, where patients are included in the treatment group to which they were randomized. Patients who were randomized but never dosed are not included in the analysis.||copies/mL||95% Confidence Interval|Mean
704438|NCT00084617|Secondary|Overall Survival|Length of time patients survived after treatment|at 40 months from study activation|All patients enrolled in study||months||95% Confidence Interval|Median
704439|NCT00084617|Secondary|Complete Response (CR) and Partial Response (PR) Duration|The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started).|at 40 months from study activation|Patients that achieved either a CR or PR.||months||95% Confidence Interval|Median
704440|NCT00084617|Primary|Response Rates (RR) in Metastatic Gastric/GE Junction Tumors|Response is defined as the number of patients with a CR (Complete Response) or PR (Partial Response) per Response Evaluation Criteria in Solid Tumor (RECIST criteria). Possible evaluations include: CR: Disappearance of all target lesions. PR: At least a 30% decrease in the size of target lesions. Progressive Disease (PD): At least a 20% increase in the size of the target lesions or appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage or increase of target lesions.|at 12 weeks (after 2 cycles of treatment)|Patients that completed at least 2 cycles of treatment||participants|||Number
704441|NCT00084682|Secondary|Overall Survival|All time to event endpoints will be evaluated using Kaplan Meier estimates and survival curves will be generated based on these estimates. One and two-year survival and median survival time (if attained) will be estimated and reported with 95% confidence limits. If the sample sizes are sufficient, subgroup analysis based on baseline factors will be performed using the log rank test to compare survival curves.|Up to 2 years||||||
704442|NCT00084682|Secondary|Time to Progression|All time to event endpoints will be evaluated using Kaplan Meier estimates and survival curves will be generated based on these estimates.|Up to 2 years||||||
704443|NCT00084682|Secondary|Duration of Response||Up to 2 years||||||
704444|NCT00084682|Primary|Disease Control (i.e., Achievement of Complete Response, Partial Response, or Stable Disease)|Tumor response was assessed every eight weeks by CT/MRI using RECIST (Response Evaluation Criteria in Solid Tumors) criteria|Up to 2 years|||participation||95% Confidence Interval|Number
704445|NCT00084747|Secondary|Overall Survival||up to 5 years from time of consent|||months||Full Range|Median
704446|NCT00084747|Primary|Progression-free Survival|Disease Progression: The day when bone marrow recurrence and/or new lytic bone marrow lesions on radiograph and/or progressive M-component paraprotein (~ 25% increase) were detected. Paraprotein progression will be confirmed labs on the consecutive month.|signed consent to progression or end of trial. Up to 5 years.|||months||Full Range|Median
704447|NCT00084838|Other Pre-specified|Grade 3-4 Allergy/Immunology|All Grade 3-4 Allergy/Immunology events based on CTCAEv2 as reported on case report forms.|Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.|The analysis population excludes 1 patient who withdrew before treatment.||adverse events|||Number
704448|NCT00084838|Other Pre-specified|Grade 3-4 Hemorrhage Events|All Grade 3-4 Hemorrhage events based on CTCAEv2 as reported on case report forms.|Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.|The analysis population excludes 1 patient who withdrew before treatment.||adverse events|||Number
704449|NCT00084838|Other Pre-specified|Grade 3-4 Dermatology Events|All Grade 3-4 Dermatology events based on CTCAEv2 as reported on case report forms.|Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.|The analysis population excludes 1 patient who withdrew before treatment.||adverse events|||Number
704450|NCT00084838|Other Pre-specified|Grade 3-4 Renal/Genitourinary Events|All Grade 3-4 Renal/Genitourinary events based on CTCAEv2 as reported on case report forms.|Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.|The analysis population excludes 1 patient who withdrew before treatment.||adverse events|||Number
704451|NCT00084838|Other Pre-specified|Grade 3-4 Pulmonary Events|All Grade 3-4 Pulmonary events based on CTCAEv2 as reported on case report forms.|Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.|The analysis population excludes 1 patient who withdrew before treatment.||adverse events|||Number
704452|NCT00084838|Other Pre-specified|Grade 3-4 Cardiovascular Events|All Grade 3-4 Cardiovascular events based on CTCAEv2 as reported on case report forms.|Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.|The analysis population excludes 1 patient who withdrew before treatment.||adverse events|||Number
704453|NCT00084838|Other Pre-specified|Grade 3-4 Hepatic Events|All Grade 3-4 Hepatic events based on CTCAEv2 as reported on case report forms.|Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.|The analysis population excludes 1 patient who withdrew before treatment.||adverse events|||Number
704454|NCT00084838|Other Pre-specified|Grade 3-4 Muscloskeletal Events|All Grade 3-4 Muscloskeletal events based on CTCAEv2 as reported on case report forms.|Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.|The analysis population excludes 1 patient who withdrew before treatment.||adverse events|||Number
704455|NCT00084838|Other Pre-specified|Grade 3-4 Constitutional Events|All Grade 3-4 Constitutional events based on CTCAEv2 as reported on case report forms.|Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.|The analysis population excludes 1 patient who withdrew before treatment.||adverse events|||Number
704456|NCT00084838|Other Pre-specified|Grade 3-4 Pain Events|All Grade 3-4 Pain events based on CTCAEv2 as reported on case report forms.|Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.|The analysis population excludes 1 patient who withdrew before treatment.||adverse events|||Number
704457|NCT00084838|Other Pre-specified|Grade 3-4 Neurology Events|All Grade 3-4 Neurology events based on CTCAEv2 as reported on case report forms.|Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.|The analysis population excludes 1 patient who withdrew before treatment.||adverse events|||Number
704458|NCT00084838|Other Pre-specified|Grade 3-4 Infection/Febrile Neutropenia Events|All Grade 3-4 Infection/Febrile Neutropenia events based on CTCAEv2 as reported on case report forms.|Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.|The analysis population excludes 1 patient who withdrew before treatment.||adverse events|||Number
704459|NCT00084838|Other Pre-specified|Grade 3-4 Metabolic/Laboratory Events|All Grade 3-4 Metabolic/Laboratory events based on CTCAEv2 as reported on case report forms.|Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.|The analysis population excludes 1 patient who withdrew before treatment.||adverse events|||Number
704460|NCT00084838|Other Pre-specified|Grade 3-4 Gastrointestinal Events|All Grade 3-4 Gastrointestinal events based on CTCAEv2 as reported on case report forms.|Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.|The analysis population excludes 1 patient who withdrew before treatment.||adverse events|||Number
704461|NCT00084838|Other Pre-specified|Grade 3-4 Blood/Bone Marrow Events|"All Grade 3-4 Blood/Bone Marrow events based on CTCAEv2 as reported on case report forms.
Arm Name"|Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.|The analysis population excludes 1 patient who withdrew before treatment.||adverse events|||Number
704462|NCT00084838|Other Pre-specified|Grade 3-4 Auditory/Hearing Events|All Grade 3-4 Auditory/Hearing events based on CTCAEv2 as reported on case report forms.|Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.|The analysis population excludes 1 patient who withdrew before treatment.||adverse events|||Number
704463|NCT00084838|Other Pre-specified|Grade 3/4 Events|All Grade 3-4 events based on CTCAEv2 as reported on case report forms.|Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.|The analysis population excludes 1 patient who withdrew before treatment.||adverse events|||Number
704464|NCT00084838|Secondary|Pre-Radiation Therapy Chemotherapeutic Response|"Response pre-RT/post-CT was defined as follows with overall response defined as achieving PR or CR.
Complete Response (CR): Complete resolution of all initially demonstrable tumor on MRI or CT evaluation w/o appearance of any new areas of disease; negative CSF cytology. Partial Response (PR): >/= 50% decrease in the sum of the products of the maximum perpendicular diameters of the tumor (sum LD) relative to baseline w/o appearance of any new areas of disease; CSF cytology unchanged from that at diagnosis or clearing after being initially positive Stable Disease (SD): <50% decrease in the sum LD w/o appearance of any new areas of disease; CSF cytology unchanged from that at diagnosis or clearing after being initially positive Progressive Disease (PD): >/= 25% increase in the sum LD relative to baseline, or the appearance of any new areas of disease or appearance of positive cytology after two consecutive negative samples."|Assessed at study entry and pre-RT/post-CT at week 7.|The pre-RT CT response evaluable population is defined as patients who completed chemotherapy per protocol.||proportion of evaluable patients||90% Confidence Interval|Number
704465|NCT00084838|Primary|2-yr Overall Survival|Overall survival is defined as the time from date of diagnosis to death or date of last follow-up. 2-year overall survival is the probability of patients remaining alive at 2-years from study entry estimated using Kaplan-Meier (KM) methods which censors patients at date of last follow-up. Precision of this conditional probability estimate was measured in terms of standard error. Median OS, the original primary endpoint, was not estimable based on the Kaplan-Meier method because of insufficient follow-up.|Patients are followed for survival up to 5 yrs post-therapy completion or death; As of this analysis, median follow-up among survivors was 31 months with the longest follow-up being 40 months.|The analysis dataset is comprised of all eligible and treated patients.||probability|||Number
704466|NCT00084864|Secondary|Number of Participants With Adverse Events, Graded According to NCI CTCAE v2.0|Number of Participants with Adverse Events, Graded According to NCI CTCAE v2.0|Up to 30 days of the last administration of study procedure|All treated and eligible patients||Participants|||Count of Participants
704467|NCT00084864|Secondary|Determine the Acute Effects of This Regimen on Serum PSA in These Patients.||Up to 30 days of the last administration of study procedure|Study was activated in 9/2002 which was prior to Roswell Park Cancer Institute (RPCI) putting a system in place to centralize data entry and data management. Data entry of the outcomes was done by PI's staff and has since been lost. All attempts to retrieve the data have failed.|||||
704468|NCT00084864|Secondary|Determine the Effect of This Regimen on the Expression of Apoptosis Markers|Determine the effect of this regimen on the expression of apoptosis markers, p21, p27, prostate-specific antigen (PSA), prostate-specific membrane antigen, and VDR expression in tumor-associated vascular endothelial cells and endothelium derived from normal-appearing prostate and tumor in these patients.|Up to 30 days of the last administration of study procedure|Study was activated in 9/2002 which was prior to Roswell Park Cancer Institute (RPCI) putting a system in place to centralize data entry and data management. Data entry of the outcomes was done by PI's staff and has since been lost. All attempts to retrieve the data have failed.|||||
704469|NCT00084864|Secondary|Effect of Preoperative High-dose Calcitriol and Dexamethasone on Extent of Prostatic Intraepithelial Neoplasia (PIN) at 1, 2, 3, and 12 Months Post Prostatectomy||Up to 30 days of the last administration of study procedure|Study was activated in 9/2002 which was prior to Roswell Park Cancer Institute (RPCI) putting a system in place to centralize data entry and data management. Data entry of the outcomes was done by PI's staff and has since been lost. All attempts to retrieve the data have failed.|||||
704470|NCT00084864|Primary|Effect of Preoperative High-dose Calcitriol and Dexamethasone on Prostatic Tumor Vessel Density Measured at 1, 2, 3, and 12 Months Post Prostatectomy||Up to 30 days of the last administration of study procedure|Study was activated in 9/2002 which was prior to Roswell Park Cancer Institute (RPCI) putting a system in place to centralize data entry and data management. Data entry of the outcomes was done by PI's staff and has since been lost. All attempts to retrieve the data have failed.|||||
704471|NCT00085098|Secondary|Quality of Life (QOL) and Neurocognitive Assessment (NP)|The primary endpoints for QOL and NP assessments will be the global scale value from each of these instruments at the two-year time point. Analyses of subscales (if they exist) and of assessments at other times will be of secondary interest. It is assumed that scale values are standardized to a reference normal population. Comparisons of each treatment group with the standard population mean, using a two-sided test with Type I error 0.025 (an adjustment for multiple comparison) will be able to detect differences from the standard mean that are 20% smaller.|Up to 2 years||||||
704472|NCT00085098|Secondary|Toxicity and Safety as Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0|The analysis of toxicity will focus on estimating the rates of key acute and subacute toxicity occurring during the first induction chemotherapy. Estimates will be obtained using life-table methods with an event defined as the first occurrence of a key acute or sub-acute toxicity. Patients who have progression or recurrence of disease will be censored in these analyses. The precision of the estimates of toxicity rate can be approximated by an analysis of binomial proportions.|From the beginning of treatment, assessed up to 5 years||||||
704473|NCT00085098|Secondary|Response||Up to 5 years||||||
704474|NCT00085098|Primary|Event-free Survival|"Data will be summarized as number of patients in the following categories at the time of data cutoff for analyses of 3-year EFS: 1)Experienced a qualifying event (QE) (see below);2)Event-free through 3 years of follow-up;3)Event-free until data cutoff (if less than 3 years of follow-up);4)Withdrew from study;5)Lost to follow-up.
QEs: 1)disease progression, defined as increase >= 40% in tumor volume or >= 25% in tumor area of target lesions;2)development of new lesions;3)occurrence of a second malignant neoplasm, defined as a malignancy with different histological type from trial-qualifying diagnosis;4)death from any cause.
Stat. analyses will be based on time from enrollment to the earliest of: 1)occurrence of any of the QEs;2)withdrawal from study or lost to follow-up;3)completion of three years of follow-up event-free;4)data cutoff for completion of the statistical analyses for the protocol’s primary objective.
NOTE: Reported data are through May 2009 (see Caveats section)."|Study enrollment until date of earliest qualifying event (QE), date last known to be QE-free if the patient is followed for less than three years and is QE-free at the time of analysis, or 3 years if the patient is QE-free at 3 years|By protocol design, all eligible patients were considered in the evaluation of primary study aim. Two (2) patients were considered ineligible. All other patients (10 enrolled to regimen A and 12 enrolled to regimen B) are included in the evaluation for the primary outcome measure.||participants|||Number
704475|NCT00085202|Secondary|Mean RT Dose to Specified Target Tissue Volume by Rate and Pattern of Failure, e.g. Local Failure, Distant Failure, Etc.|To correlate radiation dosimetry of target and normal tissues with rate and patterns of failure and longitudinal measures of audiometric, endocrine and cognitive effects.|Once all patients have been followed for 2 years||||||
704476|NCT00085202|Secondary|Number of Average Risk Patients Whose Treatment Failure Included the Posterior Fossa|To monitor for treatment failure in the posterior fossa of patients whose tumor bed receives a reduced volume of radiation.|Annually for 6 years post irradiation||||||
704477|NCT00085202|Secondary|Reading Decoding Composite Scores in the Intervention and Standard of Care Groups|To compare the effects of a computer-based training system specifically targeting language, reading, and learning skills (Fast ForWord, Scientific Learning Corporation) with the current standard of care on reading decoding skills as measured by individual academic testing.|Measurements will be made at time of randomization, at 3 months from initiation of treatment, and yearly thereafter for 10 years||||||
704478|NCT00085202|Primary|Frequency of Mutations Associated With SHH and WNT Tumors|"To estimate the frequency of mutations associated with SHH and WNT tumors via targeted sequencing.
This outcome was initially expected to be completed by September 2014. Technologic advancements have improved sequencing on formalin fixed paraffin embedded material using smaller quantities of nucleic acids. However, given that this technology is new, we had to thoroughly evaluate it on samples with abundant material first so as not to use up precious patient samples that are available in small quantities. The project has been delayed since extra time and care has gone into evaluating this technology to ensure that the data yield is accurate. We are now proceeding with a methodology that meets our quality controls."|within 3.5 years following completion of accrual||||||
704479|NCT00085202|Primary|Progression-Free Survival (PFS) Compared Between ERBB2 Assessment and Risk Group.|122 participants with a diagnosis of medulloblastoma were grouped by ERBB2 positive/negative assessment and risk group into 4 groups. Progression-free survival was calculated from the date of diagnosis to the date of disease progression/relapse, the date of death, or the date of last contact. The log-rank test was used to compare the PFS distributions of ERBB2 groups.|2 years after tumor cell analysis in 122 participants|Analysis was completed for the first 122 participants with a diagnosis of medulloblastoma and with fresh tissue and ERBB2 protein assessments. Participants with a diagnosis of PNET, PNET variants, or ATRT were not included in this analysis.||percentage of participants||Standard Error|Mean
704480|NCT00085202|Primary|Progression-Free Survival (PFS) in ERBB2-Negative Tumors Compared to ERBB2-Positive Tumors|The relationship between ERBB2 protein expression in tumors and progression-free survival was assessed in 122 participants with a diagnosis of medulloblastoma and with ERBB2 protein assessments. If the ERBB2 value was greater than zero, the ERBB2 was defined as positive for the participant. If the ERBB2 value was zero, the ERBB2 was defined as negative. Progression-free survival was calculated from the date of diagnosis to the date of disease progression/relapse, the date of death, or the date of last contact. The log-rank test was used to compare the PFS distributions of ERBB2 groups.|2 years after tumor cell analysis in 122 participants|Analysis included the first 122 participants with a diagnosis of medulloblastoma and with fresh tissue and ERBB2 protein assessments. Participants with a diagnosis of PNET, PNET variants, or ATRT were not included in this analysis.||probability of PFS at 2 years||Standard Error|Mean
704481|NCT00085254|Primary|Overall Survival (Phase II)|The overall survival is calculated from time of histological diagnosis to death occurance - median based on all 112 patients, all dose levels|up to 36 months|||months||95% Confidence Interval|Median
704482|NCT00085254|Secondary|Frequency of Hematologic and Nonhematologic Adverse Events|The proportion of patients with grade 3 and grade 4 hematologic and non hematologic adverse events per CTCAE 4.0|Up to 1 year|||Number of grade 3 or 4 events|||Number
704483|NCT00085254|Secondary|Overall Survival Based on Dose Level - Phase 2|survival calculated from date of initial histologic diagnosis and occurence of death. Pts at 500mg dose compared against Pts treated at 2000mg dose. Calculated using median|Up to 3 years|Phase 2 subjects only - does not include the 18 subjects from the safety run-in portion of study||months||95% Confidence Interval|Median
704484|NCT00085254|Primary|Maximum Tolerated or Tolerable Dose (MTD) - 3 Pre-defined Doses|"pts will be evaluated from first dose through end of initiation cycle. (6 weeks of RT+TMZ +EMD and 4 weeks of EMD alone) to review any dose limiting toxicity (DLT) using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (safety run-in)
DLT defined as: Known TMZ hematological toxicities will not be considered dose limiting.
cohorts at these 3 defined doses: 500mg, 1000mg and 2000mg MTD defined as: dose producing DLT in 2 out of 6 patients or dose level below the dose which produced DLT in >/= 2 out of 3 patients, or in >/= 3 out of 6 patients If no MTD (maximum tolerable dose) was defined through 3 steps of dose escalation, phase 2 will proceed with a randomized treatment allocation of the two pre-specified dosage arms: low dose; 500mg and high dose; 2000mg"|10 weeks|at least 3 pts per cohort will be used to review MTD rate for dose escalation in stepwise fashion of 3 defined doses: 500, 1000 and 2000mg. We will enroll 6 pts to ensure that 3 pts are evaluable due to high drop out rate.||mg|||Number
731768|NCT00399542|Secondary|Month 2 Spontaneous Bowel Movement Rates Change From Baseline|Any bowel movement not associated with rescue medication use|28 days|ITT with LOCF||SBMs/week||Standard Deviation|Mean
704485|NCT00085254|Primary|Dose Limiting Toxicities of EMD + RT and TMZ|"pts will be evaluated from first dose through end of initiation cycle. (6 weeks of RT+TMZ +EMD and 4 weeks of EMD alone) to review dose limiting toxicity (DLT) using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase I)
DLT defined as: Known TMZ hematological toxicities will not be considered dose limiting.
Nonhematological toxicities Grades 3-4 severity (except nausea and vomiting without sufficient antiemetic prophylaxis)"|10 weeks|at least 3 pts per cohort will be used to review DLT rate for dose escalation in stepwise fashion. we will enroll 6 pts to ensure that 3 pts are evaluable due to high drop out rate.||participants|||Number
704486|NCT00085293|Secondary|Frequency of Adverse Events According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0|Summary of Adverse Events (AEs) by Maximum Grade where Grade 1 AEs >20%, Grade 2 AEs >10%, all Grade 3, Grade 4 and Grade 5 reported.|Up to 6 months|||percentage of participants|||Number
704487|NCT00085293|Secondary|Change in Fludeoxyglucose (FDG) Uptake Measured by Positron Emission Tomography (PET) in Metastatic Tumor Sites Before and After DNA-methyltransferase Inhibitor Therapy (Optional)||Baseline to 3 weeks||||||
704488|NCT00085293|Secondary|Efficacy of Subsequent Radioiodine Therapy in Terms of CR/PR/SD of Any Radiographic Disease|Response Evaluation Criteria in Solid Tumors (RECIST): Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|6 months||||||
704489|NCT00085293|Secondary|Efficacy of Subsequent Radioiodine Therapy in Terms of Complete Response (CR)/Partial Response (PR)/Stable Disease (SD) of Any Radiographic Disease|Response Evaluation Criteria in Solid Tumors (RECIST): Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|3 months||||||
704490|NCT00085293|Secondary|Efficacy of Subsequent Radioiodine Therapy in Terms of Change in Serum Thyroglobulin Level||6 months||||||
704491|NCT00085293|Secondary|Efficacy of Subsequent Radioiodine Therapy in Terms of Change in Serum Thyroglobulin Level||3 months||||||
704492|NCT00085293|Primary|Restoration of Radioiodine Uptake in Metastatic Lesions as Demonstrated by Diagnostic Whole-body Scanning After Decitabine Administration|"Number of participants with restoration of radioiodine responsiveness as determined by visible uptake on radioiodine scan in radiographically detectable metastatic foci of papillary or follicular thyroid carcinoma. Response to Decitabine defined as demonstration of radioiodine uptake determined by centralized blinded review of diagnostic scan. All who demonstrated radioiodine uptake in metastatic foci following decitabine therapy would then undergo thyroid hormone withdrawal and a second course of decitabine in preparation for therapeutic administration of radioiodine.
Diagnostic radioiodine scans following decitabine therapy (week 3) with a radioiodine scan following thyrotropin alfa stimulation, 0.9 mg intramuscular (IM) injection 24 and 48 hours before administration of the 131I for imaging. Whole body scans (WBS) performed using a gamma camera."|Week 3 following 2 weeks of Decitabine therapy|Per protocol, 1 participant interpreted by local treating investigator as responsive (increased radioiodine uptake on diagnostic scan after therapy), entered second decitabine treatment receiving radioiodine therapeutic dose. Subsequent central review of both scans for formal protocol response interpreted scans as negative for radioiodine uptake.||participants|||Number
704493|NCT00085410|Post-Hoc|6-Month and 1-Year Survival: Patients Who Did Not Derive Clinical Benefit From Study Treatment|The time from initiation of therapy to 6 months beyond. Only patients who did not derive clinical benefit from study treatment (progressive disease or unconfirmed partial response was best response) were included.|Up to 1 year|Patients who did not derive clinical benefit from study treatment (progressive disease was best response) only.||percentage of patients|||Number
704494|NCT00085410|Post-Hoc|6-Month and 1-Year Survival for Patients Who Derived Clinical Benefit From Study Treatment|The time from initiation of therapy to 6 months beyond. Only patients who derived benefit from study treatment (stable disease, partial response, or complete response was best response) were included.|Up to 1 year|Patients who derived benefit from study treatment (stable disease, partial response, or complete response was best response)||percentage of patients|||Number
704495|NCT00085410|Post-Hoc|1-year Survival|The time from initiation of initiation of therapy to 1 year beyond.|1 year|1 patient who withdrew consent prior to the first disease evaluation was excluded.||percentage of patients|||Number
704496|NCT00085410|Post-Hoc|6-Month Survival|The time from initiation of therapy to 6 months beyond.|6 months|1 patient who withdrew consent prior to the first disease evaluation was excluded.||percentage of patients|||Number
704497|NCT00085410|Post-Hoc|Clinical Benefit Rate|Best response to study treatment was confirmed complete response, partial response, or stable disease. Unconfirmed partial response was not included. The outcome measure data table is stratified into patients who a) received prior therapy b) did not receive prior therapy.|Up to 1 year|1 patient who withdrew consent prior to the first disease evaluation was excluded.||percentage of patients|||Number
704498|NCT00085410|Secondary|Correlation of Treatment With Changes in Phenotypic Expression of Molecular Markers|Phenotypic expression of molecular markers before and after study treatment|Duration of study treatment|Insufficient amount of patient samples collected for analysis|||||
704499|NCT00085410|Secondary|Correlation of Phenotypic Expression of NF-kB, p53, and Other Molecular Markers in Biliary Washings and Tumor Biopsies With Clinical Outcomes|Evaluation of clinical outcomes with expression of molecular markers specified and others. Sufficient amount of biliary washings and tumor biopsies needed for analysis.|Once in the screening period (within 14 days of starting treatment)|Insufficient amount of patient samples collected for analysis|||||
704523|NCT00091507|Primary|Progression of Acute Coronary Syndrome to Myocardial Infarction|Outcome for all participants during the first 24 hours of hospitalization; evidence of myocardial infarction is determined by ECG and biomarker results.|24 hours|||participants|||Number
704500|NCT00085410|Secondary|Correlation of the Degree of Proteasome Inhibition in Peripheral Blood With the Degree of Proteasome Inhibition in Tumor Specimens|Proteasome inhibition compared between tumor specimens and peripheral blood. Sufficient tissue samples are required for this analysis.|Once in the screening period (within 14 days of starting treatment)|Insufficient amount of patient samples collected for analysis|||||
704501|NCT00085410|Secondary|Overall Survival|The time from initiation of therapy to death or last follow-up.|Up to 1 year|1 patient who withdrew consent prior to the first disease evaluation was excluded.||months||95% Confidence Interval|Median
704502|NCT00085410|Secondary|Time to Disease Progression|Time from initiation of therapy to first progressive disease.|Up to 1 year|1 patient who withdrew consent prior to the first disease evaluation was excluded.||months||95% Confidence Interval|Median
704503|NCT00085410|Primary|Objective Response Rate|Objective Response Rate (ORR) was determined by best response on radiologic assessment (computed tomography or magnetic resonance imaging) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.0.|Up to 1 year|Per protocol||Participants|||Count of Participants
704504|NCT00091260|Secondary|Number of Patients Who Received Both CC-5013 and Dexamethasone and Had a Hematologic Response||1 year|||participants|||Number
704505|NCT00091260|Primary|Number of Patients With Hematologic Response With Single-agent CC-5013|"Complete response = Absence of detectable monoclonal protein in serum or urine by immunofixation electrophoresis, less than 5% plasma cells on bone marrow biopsy without clonal dominance of kappa or lambda isotype, and normal serum free light chain assay.
Partial response= For patients with detectable and quantifiable monoclonal marrow plasmacytosis= a reduction of 50% or more in plasma cells as a percentage of nucleated bone marrow cells. For patients with a detectable monoclonal peak on serum or urine protein electrophoresis= a reduction in the peak height of 50% or more.
For patients with quantifiable urinary kappa or lambda chain concentration= a 50% reduction in daily light chain excretion in 24 hour urine.
For patients with an elevated serum free light chain assay, a reduction of 50% or more."|3 months|Participants who received at least 3 cycles of single-agent CC-5013 and underwent subsequent evaluation.||Participants|||Count of Participants
704506|NCT00091260|Primary|Number of Patients Removed From Study Treatment Due to Toxicities||1 year|Number of patients who had at least one dose of CC-5013||participants|||Number
704507|NCT00091273|Secondary|Measure of Tumor-antigen-specific Immunity in PBMC by Elispot Assay||Days 1,8,15,22,29,36,43,50 and Month 3|All treated subjects were assessed.||participants|||Number
704508|NCT00091273|Primary|Measure of Tumor-antigen-specific Immunity in SIN by ELIspot Assay||Day 22|All treated subjects were assessed.||participants|||Number
704509|NCT00091273|Primary|Safety of the Vaccine|Participants kept a toxicity diary during the time frame of interest which was reviewed with a study clinician at each visit.|Days 1,8,15,22,29,36,43,50|All treated subjects were assessed.||participants|||Number
704510|NCT00091390|Secondary|Clinical Progression Including Local/Regional and Distant Relapse||From registration to the date of local/regional progression or distant relapse, or last follow-up. Analysis occurs after each patient has had 3 years of follow-up.||||||
704511|NCT00091390|Secondary|Disease-specific Survival||From registration to the date of death due to prostate cancer or other disease related cause. Analysis occurs after each patient has had 3 years of follow-up.||||||
704512|NCT00091390|Secondary|Overall Survival||From registration to the date of death or last follow-up. Analysis occurs after each patient has had 3 years of follow-up.||||||
704513|NCT00091390|Secondary|Biochemical Failure||From registration to the date of biochemical failure or last follow-up. Analysis occurs after each patient has had 3 years of follow-up.||||||
704514|NCT00091390|Secondary|Acute Severe GU and GI Toxicity as Measured by Common Terminology Criteria for Adverse Events (CTCAE) v3.0 Within 9 Months of Starting Treatment||From registration until 9 months from the start of treatment||||||
704515|NCT00091390|Primary|Late Severe Genitourinary (GU) and Gastrointestinal (GI) Toxicity at 18 Months|Eighteen-month rate of late severe (grade 3-5) genitourinary (GU) and gastrointestinal (GI) toxicity, defined as starting more than 9 months from treatment start, and graded by CTCAE v3.0|Beginning nine months after start of treatment.|All eligible patients.||percentage of participants||95% Confidence Interval|Number
704516|NCT00091442|Primary|Time to Progression|Time interval in months between the date of randomization and the date of disease progression or death due to progression, whichever occurred first.|From date of randomization until date of disease progression or death, whichever occurred first, until approximately 485 events of disease progression or death were observed, as assessed approximately 15 months after the last patient was enrolled|Intent to Treat: For patients who were progression free at the time of data cutoff, data were censored for time to progression at the time of their last tumor assessment.||Months||95% Confidence Interval|Median
704517|NCT00091442|Secondary|Response Rate: Number of Participants in the Evaluable Population Who Achieved a Complete Response (CR) or Partial Response (PR)|Number of participants in the evaluable population who achieved a CR or PR as per Response Evaluation Criteria In Solid Tumors (RECIST) criteria. CR: Disappearance of all target lesions and PR: at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD. Response was assessed by Computed Tomography (CT)/Magnetic Resonance Imaging (MRI).|Up to 30 to 42 days after last dose of study medication|Evaluable population: Included all randomized participants who received at least 1 dose of study medication (DOXIL or docetaxel), and who had at least 1 postbaseline tumor assessment.||Participants|||Number
704518|NCT00091442|Secondary|Overall Survival|Time interval in months between the date of randomization and the participant's death from any cause.|From the date of randomization until the participant's death from any cause, as assessed until approximately 485 death events were observed which is assessed approximately 25 months after the last patient was enrolled|Intent to Treat: If the date of death was unknown, the data were censored at the date that the participant was last known to have been alive.||Months||95% Confidence Interval|Median
704519|NCT00091507|Secondary|Cardiac Arrest or Acute Mortality|Outcome for all participants (composite of cardiac arrest or acute mortality)|Prehospital setting through hospitalization|||participants|||Number
704520|NCT00091507|Secondary|Mortality|Outcome for all participants (mortality at 30 days).|30 days|30 day mortality.||participants|||Number
704521|NCT00091507|Secondary|Heart Failure or Death|Outcome for all participants (composite of re-hospitalization for heart failure or death within 30 days)|30 days|||participants|||Number
704525|NCT00091949|Secondary|Decline in Cognitive Status|Change in modified mental status examination (3MS) score from baseline to exit. Theoretical range of 3MS scores is 0-100. Baseline scores ranged from 22-100.|Annual measures from baseline to exit (up to 5 years)|Participants with baseline and at least 1 follow-up modified mini-mental examination score.||units on a scale||Standard Error|Mean
704526|NCT00091949|Secondary|All Cause Mortality||5 years|||participants|||Number
704527|NCT00091949|Secondary|Development of Overt Diabetes||5 years|||participants|||Number
704528|NCT00091949|Secondary|Acute Coronary Syndrome|Fatal or non-fatal acute myocardial infarction or unstable angina|5 years|||participants|||Number
704529|NCT00091949|Secondary|Fatal or Non-fatal Stroke Alone||5 years|||participants|||Number
704530|NCT00091949|Primary|Recurrent Fatal or Non-fatal Stroke, or Fatal or Non-fatal Myocardial Infarction||Up to 5 years|||participants|||Number
704531|NCT00091962|Secondary|Disease-Specific Health-Related Quality of Life|The 12-item Duke Activity Status Index (DASI). Scores range from 0-58.2, and higher scores the better the functional capacity (Am J Cardiol. 1989;64(10):651-654).|8 months post CABG|||units on a scale||Standard Error|Mean
704532|NCT00091962|Secondary|Generic Physical Health-Related Quality of Life|"The 36-item Medical Outcomes Study Form (v.2) Physical Component Scale (SF-36 PCS). Range 0-100; Population norm is 50 with standard deviation of 10. Higher scores are better.
Ware J, Kosinski M, Keller S. SF-36 Physical and Mental Health Summary Scales: A User’s Manual. 2nd ed. Boston, MA: New England Medical Center; 1994."|8 months post CABG|||participants||Standard Error|Mean
704533|NCT00091962|Secondary|Hamilton Rating Scale for Depression|The 17-item Depression Interview and Structured Hamilton (DISH) version of the Hamilton Rating Scale for Depression Standard provides an accurate DSM-IV diagnosis of a cardiac patient’s mood disorder and a reliable HRS-D score. Range 0-52. Higher scores are worse. Psychosom Med. 2002;64(6):897-905|8 months post CABG|||units on a scale||Standard Error|Mean
704534|NCT00091962|Primary|Generic Mental Health-Related Quality of Life|"The 36-item Medical Outcomes Study Form (v.2) Mental Component Scale (SF-36 MCS). Range 0-100; Population norm is 50 with standard deviation of 10. Higher scores are better.
Ware J, Kosinski M, Keller S. SF-36 Physical and Mental Health Summary Scales: A User’s Manual. 2nd ed. Boston, MA: New England Medical Center; 1994."|Measured 8 months post-CABG|||units on a scale||Standard Error|Mean
704535|NCT00092118|Secondary|Mean Change From Baseline in Rhinoconjunctivitis Quality-of-life Questionnaire (RQLQ) Overall Score After the 6 Week Treatment Period|Patients completed the validated, self-administered RQLQ which included 28 items on a 7-point scale [Score 0 (best) to 6 (worst)] across 7 domains: activities, sleep, nonnose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. The scores for each domain were averaged, then scores for the 7 domains were averaged to obtain the overall score.|Baseline and Week 6|The primary efficacy analyses were performed using a modified intention-to-treat (MITT) approach. Patients were excluded if no baseline or treatment period data were available||Score on a scale||95% Confidence Interval|Least Squares Mean
704536|NCT00092118|Secondary|Patient’s Global Evaluation of Allergic Rhinitis at the End of the 6 Week Treatment Period|An evaluation by the patient, administered at the last visit (or upon discontinuation) using a 7-point scale [Score 0 (best) to 6 (worst)], in answer to a single question regarding the change in symptoms as compared to the beginning of the study.|At the end of the 6 week treatment period|The analysis was performed using a modified intention-to-treat (MITT) approach. Patients were excluded if no treatment period data were available.||Score on a scale||95% Confidence Interval|Least Squares Mean
704537|NCT00092118|Primary|Mean Change From Baseline in Daytime Nasal Symptoms Score Averaged Over the 6-week Treatment Period in Patients With Perennial Allergic Rhinitis|Mean change from baseline in Daytime Nasal Symptoms score averaged over the 6-week treatment period. The Daytime Nasal Symptoms score was calculated as the average of the 3 individual scores for Congestion, Rhinorrhea, and Sneezing, each rated by patients daily on a 4-point scale [Score 0 (best) to 3 (worst)].|6 week treatment period (from baseline though the end of week 6)|The primary efficacy analyses were performed using a modified intention-to-treat (MITT) approach. All patients with efficacy measurements, both at baseline and during the treatment period were included.||Score on a scale||95% Confidence Interval|Least Squares Mean
704538|NCT00092131|Secondary|Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 24 Hours Postdose|The time to recovery from maximum percent fall is the duration between the time at which the maximum percent fall in FEV1 occurs and the time when FEV1 returns to within 5% of the preexercise baseline for the first time.|Exercise challenge at 24 hours postdose|The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.||Minutes||Standard Deviation|Mean
704539|NCT00092131|Secondary|Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 12 Hours Postdose|The time to recovery from maximum percent fall is the duration between the time at which the maximum percent fall in FEV1 occurs and the time when FEV1 returns to within 5% of the preexercise baseline for the first time.|Exercise challenge at 12 hours postdose|The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.||Minutes||Standard Deviation|Mean
704540|NCT00092131|Secondary|Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 2 Hours Postdose|The time to recovery from maximum percent fall is the duration between the time at which the maximum percent fall in FEV1 occurs and the time when FEV1 returns to within 5% of the preexercise baseline for the first time.|Exercise challenge at 2 hours postdose|The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.||Minutes||Standard Deviation|Mean
704541|NCT00092131|Secondary|Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60min) at 24 Hours Postdose|The measure included only the area below the pre-exercise baseline.|Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 24 hours postdose|The secondary efficacy analysis used a MITT approach. If a patient received β-agonist rescue medication during the 60 minutes following exercise challenge, then the last pre-rescue FEV1 measurement was carried forward to 60 minutes. Patients with data from only one period were not included in the analysis.||(percent change) *minutes||Standard Deviation|Mean
731769|NCT00399542|Secondary|Month 3 Abdominal Bloating Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|28 days|ITT with LOCF||units on a scale||Standard Deviation|Mean
704542|NCT00092131|Secondary|Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60min) at 12 Hours Postdose|The measure included only the area below the pre-exercise baseline.|Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 12 hours postdose|The secondary efficacy analysis used a MITT approach. If a patient received β-agonist rescue medication during the 60 minutes following exercise challenge, then the last pre-rescue FEV1 measurement was carried forward to 60 minutes. Patients with data from only one period were not included in the analysis.||(percent change) *minutes||Standard Deviation|Mean
704543|NCT00092131|Secondary|Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60min) at 2 Hours Postdose|The measure included only the area below the pre-exercise baseline.|Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 2 hours postdose|The secondary efficacy analysis used a MITT approach. If a patient received β-agonist rescue medication during the 60 minutes following exercise challenge, then the last pre-rescue FEV1 measurement was carried forward to 60 minutes. Patients with data from only one period were not included in the analysis.||(percent change) *minutes||Standard Deviation|Mean
704544|NCT00092131|Secondary|Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Postdose Compared With Pre-exercise Baseline in Patients With Exercise-induced Bronchospasm (EIB)|In patients with EIB, the percent change from pre-exercise baseline FEV1 to the lowest FEV1 within 60 minutes after exercise challenge (24 hours post-dose). The FEV1 measurement obtained 5 minutes before the exercise challenge was the baseline, and was specific to each exercise challenge.|Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 24 hours after a single oral dose|The primary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.||Percent Change||Standard Deviation|Mean
704545|NCT00092131|Secondary|Maximum Percent Fall in FEV1 After Exercise Challenge at 12 Hours Postdose Compared With Pre-exercise Baseline in Patients With Exercise-induced Bronchospasm (EIB)|In patients with EIB, the percent change from pre-exercise baseline FEV1 to the lowest FEV1 within 60 minutes after exercise challenge (12 hours post-dose). The FEV1 measurement obtained 5 minutes before the exercise challenge was the baseline, and was specific to each exercise challenge.|Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 12 hours after a single oral dose|The primary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.||Percent Change||Standard Deviation|Mean
704546|NCT00092131|Secondary|Number of Participants Requiring ß-Agonist Rescue Medication After Exercise Challenge at 24 Hours Postdose||0-90 minutes after the exercise challenge performed at 24 hours postdose|The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.||Participants|||Number
704547|NCT00092131|Secondary|Number of Participants Requiring ß-Agonist Rescue Medication After Exercise Challenge at 12 Hours Postdose||0-90 minutes after the exercise challenge performed at 12 hours postdose|The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.||Participants|||Number
704548|NCT00092131|Secondary|Number of Participants Requiring ß-Agonist Rescue Medication After Exercise Challenge at 2 Hours Postdose||0-90 minutes after the exercise challenge performed at 2 hours postdose|The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.||Participants|||Number
704549|NCT00092131|Primary|Maximum Percent Fall in FEV1 After Exercise Challenge at 2 Hours Postdose Compared With Pre-exercise Baseline in Patients With Exercise-induced Bronchospasm (EIB)|In Participants with EIB, the percent change from pre-exercise baseline FEV1 to the lowest FEV1 within 60 minutes after exercise challenge (2 hours post-dose). The FEV1 measurement obtained 5 minutes before the exercise challenge was the baseline, and was specific to each exercise challenge.|Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 2 hours after a single oral dose|The primary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.||Percent Change||Standard Deviation|Mean
704550|NCT00092417|Other Pre-specified|Number of Participants With Fevers ≥101.0°F [≥38.3°C]|Maximum reported oral or equivalent temperature ≥101.0°F [≥38.3°C] was reported Day 1 through Day 21 postvaccination.|Day 1-21 postvaccination|The population for the safety analyses consisted of all vaccinated participants who had safety follow-up data. 5 participants in the Zoster Vaccine Higher Potency group and 3 participants in the Zoster Vaccine Lower Potency group were not included in this analysis since these participants were without a follow-up.||Participants|||Number
704551|NCT00092417|Other Pre-specified|Number of Participants With Herpes Zoster (HZ) or HZ-like Rashes|Noninjection-site rash Day 1 through Day 42 postvaccination was reported by the participant to the investigator and confirmed to be zosteriform rash by the study physician and polymerase chain reaction (PCR).|Day 1-42 postvaccination|The population for the safety analyses consisted of all vaccinated participants who had safety follow-up data.||Participants|||Number
704552|NCT00092417|Other Pre-specified|Number of Participants With Varicella or Varicella-like Noninjection-site Rashes, Nondermatomal in Distribution With >100 Lesions|Noninjection-site rash Day 1 through Day 42 postvaccination was reported by the participant to the investigator and confirmed to be varicelliform rash by the study physician and polymerase chain reaction (PCR).|Day 1-42 postvaccination|The population for the safety analyses consisted of all vaccinated participants who had safety follow-up data.||Participants|||Number
704553|NCT00092417|Primary|Number of Participants With Moderate or Severe Injection-site Pain/Tenderness/Soreness or Swelling (> 2 Inches at Largest Diameter)||Day 1-5 postvaccination|The population for the primary safety analysis consisted of all vaccinated participants who had safety follow-up data.||Participants|||Number
704554|NCT00092417|Primary|Number of Participants With Vaccine-related Serious Clinical Adverse Experiences (SAEs)|The incidence of vaccine-related SAEs occurring Day 1 through Day 42 postvaccination. Whether a serious clinical adverse experience occurring Day 1 through Day 42 postvaccination was vaccine-related was determined by the investigator who was a qualified physician . The difference in the risk of developing a vaccine-related SAE between the two groups was compared at the 2-sided 0.05 level.|Day 1-42 post vaccination|The population for the primary safety analysis consisted of all vaccinated participants who had safety follow-up data.||Participants|||Number
704555|NCT00092443|Secondary|Number of Subjects With ≥3 Fold Rise in Antibody Titer|Induction of postdose 3 rotavirus Serum neutralizing antibody (SNA) response (Number of subjects with ≥3 fold rise in antibody titer)|14 days following the 3rd vaccination|Per Protocol Population; number randomized is different from number analyzed due to some data excluded from the analysis (e.g., unevaluable due to wild-type rotavirus-positive stool antigen EIA prior to 14 days Postdose 3, incomplete clinical and/or laboratory results, or stool samples collected out of day range.||Participants|||Number
704556|NCT00092443|Primary|Occurence of Clinical Rotavirus Disease Caused by the Composite of the Serotypes Contained Within the Vaccine More Than 14 Days Following the Third Dose.|G1, G2, G3, and G4 Serotype Rotavirus Gastroenteritis Cases Occurring at Least 14 Days Postdose 3 Through the First Rotavirus Season Postvaccination in the Per-Protocol Population Using Per-Protocol Case Definition|At least 14 days following the 3rd vaccination|Per Protocol Population; number randomized is different from number analyzed due to some data excluded from the analysis (e.g., unevaluable due to wild-type rotavirus-positive stool antigen Enzyme immunoassay (EIA) prior to 14 days Postdose 3, incomplete clinical and/or laboratory results, or stool samples collected out of day range.||Participants|||Number
704557|NCT00092456|Other Pre-specified|Number of Subjects Discontinued Due to Serious Vaccine-related Clinical Adverse Experiences (CAEs)|Serious vaccine-related CAEs are CAEs assessed by an investigator as being related to the vaccine that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is cancer; or is an overdose.|Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first|All subjects who were vaccinated and followed up||Participants|||Number
704558|NCT00092456|Other Pre-specified|Number of Subjects Discontinued Due to Serious Clinical Adverse Experiences (SCAEs)|SCAEs are any CAEs that: results in death; or is life threatening; or results in persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is cancer; or is an overdose.|Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first|All subjects who were vaccinated and followed up||Participants|||Number
704559|NCT00092456|Other Pre-specified|Number of Subjects Discontinued Due to Vaccine-Related Clinical Adverse Experiences (CAEs)|CAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product. Vaccine-related CAEs are CAEs that are assessed by an investigator who is a qualified physician as being related to the vaccine according to his/her best clinical judgment.|Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first|All subjects who were vaccinated and followed up||Participants|||Number
704560|NCT00092456|Other Pre-specified|Number of Subjects Discontinued Due to Clinical Adverse Experiences|A CAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product.|Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first|All subjects who were vaccinated and followed up||Participants|||Number
704561|NCT00092456|Other Pre-specified|Number of Subjects With Serious Vaccine-Related Clinical AEs (CAEs)|Serious vaccine-related CAEs are CAEs assessed by an investigator as being related to the vaccine that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is cancer; or is an overdose|Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first|All subjects who were vaccinated and followed up||Participants|||Number
704562|NCT00092456|Other Pre-specified|Number of Subjects With Vaccine-Related Clinical AEs (CAEs)|CAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product. Vaccine-related CAEs are CAEs that are assessed by an investigator, who is a qualified physician, as being related to the vaccine according to his/her best clinical judgment.|Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first|All subjects who were vaccinated and followed up||Participants|||Number
704563|NCT00092456|Other Pre-specified|Number of Subjects With Serious Clinical Adverse Experiences (SCAEs)|Subjects were followed for all SCAEs. SCAEs are any CAEs occurring at any dose that: results in death; or is life threatening; or results in persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is cancer; or is an overdose.|Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first|All subjects who were vaccinated and followed up||Participants|||Number
704564|NCT00092456|Other Pre-specified|Number of Subjects With Clinical Adverse Experiences (CAEs)|Subjects in this study were followed for all CAEs, including intussusception. A CAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first|Safety Population: All subjects who were vaccinated and followed up||Participants|||Number
704565|NCT00092456|Other Pre-specified|Geometric Mean Antibody Titer(s) (GMT) to Serum Anti-rotavirus Immunoglobulin A (IgA).|Post Dose 3 serum samples were assayed for serum anti-rotavirus IgA|42 days following the 3rd vaccination|Per Protocol Population; excluding protocol violators and subjects with invalid data based on laboratory determinations.||units/mL||95% Confidence Interval|Geometric Mean
704566|NCT00092456|Primary|Serum Neutralizing Antibodies (SNA) Response Against Rotavirus Serotypes G1, G2, G3, G4 and P1A[8]|Antibody response to 3 manufactured lots of RotaTeq™ and placebo groups, based on the SNA PostDose 3 geometric mean titers (GMTs) (expressed in dilution units) against rotavirus serotypes G1, G2, G3, G4 and P1A[8]|42 days following the 3rd vaccination|Per Protocol Population; excluding protocol violators and subjects with invalid data based on laboratory determinations.||dilution units||95% Confidence Interval|Geometric Mean
708923|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 1|Estimated forced expiratory volume in one second (FEV1) after bronchodilator at month 1|Month 1|||L||Standard Error|Mean
704567|NCT00092495|Primary|Geometric Mean Titer (GMT) for HPV 18 by Week 4 Postdose 3||Week 4 Postdose 3 (Month 7)|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to female subjects 10-15 years and 16-23 years.||mMU/mL||95% Confidence Interval|Geometric Mean
704568|NCT00092495|Primary|Number of Subjects Who Seroconverted for HPV 18 by Week 4 Postdose 3|"Seroconversion is defined as going from seronegative to seropositive.
Seropositivity is defined as an anti-HPV 18 titer ≥ 24 milliMerck units per milliliter (mMU/mL)."|Week 4 Postdose 3 (Month 7)|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to female subjects 10-15 years and 16-23 years.||Subjects|||Number
704569|NCT00092495|Primary|Geometric Mean Titer (GMT) for HPV 18 by Week 4 Postdose 3||Week 4 Postdose 3 (Month 7)|subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to subjects receiving 100% dosage.||mMU/mL||95% Confidence Interval|Geometric Mean
704570|NCT00092495|Primary|Number of Subjects Who Seroconverted for HPV 18 by Week 4 Postdose 3|"Seroconversion is defined as going from seronegative to seropositive.
Seropositivity is defined as an anti-HPV 18 titer ≥ 24 milliMerck units per milliliter (mMU/mL)."|Week 4 Postdose 3 (Month 7)|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to subjects receiving 100% dosage.||Subjects|||Number
704571|NCT00092495|Primary|Geometric Mean Titer (GMT) for HPV 16 by Week 4 Postdose 3||Week 4 Postdose 3 (Month 7)|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to female subjects 10-15 years and 16-23 years.||mMU/mL||95% Confidence Interval|Geometric Mean
704572|NCT00092495|Primary|Number of Subjects Who Seroconverted for HPV 16 by Week 4 Postdose 3|"Seroconversion is defined as going from seronegative to seropositive.
Seropositivity is defined as an anti-HPV 16 titer ≥ 20 milliMerck units per milliliter (mMU/mL)."|Week 4 Postdose 3 (Month 7)|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to female subjects 10-15 years and 16-23 years.||Subjects|||Number
704573|NCT00092495|Primary|Geometric Mean Titer (GMT) for HPV 16 by Week 4 Postdose 3||Week 4 Postdose 3 (Month 7)|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to subjects receiving 100% dosage.||mMU/mL||95% Confidence Interval|Geometric Mean
704574|NCT00092495|Primary|Number of Subjects Who Seroconverted for HPV 16 by Week 4 Postdose 3|Seropositivity is defined as an anti-HPV 16 titer ≥ 20 milliMerck units per milliliter (mMU/mL). Seroconversion is defined as going from seronegative to seropositive.|Week 4 Postdose 3 (Month 7)|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to subjects receiving 100% dosage.||mMU/mL|||Number
704575|NCT00092495|Primary|Geometric Mean Titer (GMT) for HPV 11 by Week 4 Postdose 3||Week 4 Postdose 3 (Month 7)|: Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to female subjects 10-15 years and 16-23 years.||mMU/mL||95% Confidence Interval|Geometric Mean
704576|NCT00092495|Primary|Number of Subjects Who Seroconverted for HPV 11 by Week 4 Postdose 3|"Seroconversion is defined as going from seronegative to seropositive.
Seropositivity is defined as an anti-HPV 11 titer ≥ 16 milliMerck units per milliliter (mMU/mL)."|Week 4 Postdose 3 (Month 7)|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to female subjects 10-15 years and 16-23 years.||Subjects|||Number
704577|NCT00092495|Primary|Geometric Mean Titer (GMT) for HPV 11 by Week 4 Postdose 3||Week 4 Postdose 3 (Month 7)|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to subjects receiving 100% dosage.||mMU/mL||95% Confidence Interval|Geometric Mean
704578|NCT00092495|Primary|Number of Subjects Who Seroconverted for HPV 11 by Week 4 Postdose 3|"Seroconversion is defined as going from seronegative to seropositive.
Seropositivity is defined as an anti-HPV 11 titer ≥ 16 milliMerck units per milliliter (mMU/mL)."|Week 4 Postdose 3 (Month 7)|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to subjects receiving 100% dosage.||Subjects|||Number
704579|NCT00092495|Primary|Geometric Mean Titer (GMT) for HPV 6 by Week 4 Postdose 3||Week 4 Postdose 3 (Month 7)|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to female subjects 10-15 years and 16-23 years.||mMU/mL||95% Confidence Interval|Geometric Mean
704580|NCT00092495|Primary|Number of Subjects Who Seroconverted for HPV 6 by Week 4 Postdose 3|"Seroconversion is defined as going from seronegative to seropositive.
Seropositivity is defined as an anti-HPV 6 titer ≥ 20 milliMerck units per milliliter (mMU/mL)."|Week 4 Postdose 3 (Month 7)|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to female subjects 10-15 years and 16-23 years.||Subjects|||Number
704581|NCT00092495|Primary|Geometric Mean Titer (GMT) for HPV 6 by Week 4 Postdose 3||Week 4 Postdose 3 (Month 7)|: Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to subjects receiving 100% dosage.||mMU/mL||95% Confidence Interval|Geometric Mean
704582|NCT00092495|Primary|Number of Subjects Who Seroconverted for HPV 6 by Week 4 Postdose 3|"Seroconversion is defined as going from seronegative to seropositive.
Seropositivity is defined as an anti-HPV 6 titer ≥ 20 milliMerck units per milliliter (mMU/mL)."|Week 4 Postdose 3 (Month 7)|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to subjects receiving 100% dosage.||Subjects|||Number
708924|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 1|Estimated FEV1 before bronchodilator at Month 1|Month 1|||L||Standard Error|Mean
704583|NCT00092521|Primary|Incidence of HPV 6/11/16/18-related External Genital Lesions (EGL) [Genital Warts, Vulvar/Vaginal Intraepithelial Neoplasia (Any Grade), Vulvar/Vaginal Cancer]||Follow-up through end of study (4 years)|"Per-protocol population: subjects must have no major protocol violations, must be seronegative to the relevant type at Day 1 and PCR negative to the relevant type through Month 7, and must provide follow-up data.
Group 2 Base Study Monovalent HPV (Type 16) Vaccine was not part of the pre-specified efficacy analysis population."||incidence rate per 100 person-years|||Number
704584|NCT00092521|Primary|Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia (CIN)(Any Grade), Adenocarcinoma In Situ (AIS) or Cervical Cancer||Follow-up through end of study (4 years)|Per-protocol population: subjects must have no major protocol violations, must be seronegative to the relevant type at Day 1 and Polymerase Chain Reaction (PCR) negative to the relevant type through Month 7, and must provide follow-up data. Group 2 Base Study Monovalent HPV Vaccine was not part of the pre-specified efficacy analysis population.||incidence rate per 100 person-years|||Number
704585|NCT00092534|Secondary|Subjects With Anti-HPV 18 Titer >/= 24 mMU/mL|Subsequent to protocol registration, an updated serology assay was used in which seropositivity was defined as >/= 24 mMU/mL|Week 4 Postdose 3|Per-protocol population: subjects must have no major protocol violations, must be seronegative to the relevant type at Day 1 and PCR negative to the relevant type through Month 7, and must provide data. Only subjects participating in a substudy had blood samples at Month 7.||Participants|||Number
704586|NCT00092534|Secondary|Subjects With Anti-HPV 16 Titer >/= 20 mMU/mL|Subsequent to protocol registration, an updated serology assay was used in which seropositivity was defined as >/= 20mMU/mL|Week 4 Postdose 3|Per-protocol population: subjects must have no major protocol violations, must be seronegative to the relevant type at Day 1 and PCR negative to the relevant type through Month 7, and must provide data. Only subjects participating in a substudy had blood samples at Month 7.||Participants|||Number
704587|NCT00092534|Secondary|Subjects With Anti-HPV 11 Titer >/= 16 mMU/mL|Subsequent to protocol registration, an updated serology assay was used in which seropositivity was defined as >/= 16 mMU/mL|Week 4 Postdose 3|Per-protocol population: subjects must have no major protocol violations, must be seronegative to the relevant type at Day 1 and PCR negative to the relevant type through Month 7, and must provide data. Only subjects participating in a substudy had blood samples at Month 7.||Participants|||Number
704588|NCT00092534|Secondary|Subjects With Anti-HPV 6 Titer >/= 20 mMU/mL|Subsequent to protocol registration, an updated serology assay was used in which seropositivity was defined as >/= 20 mMU/mL|Week 4 Postdose 3 (4 weeks after 3rd vaccine dose)|Per-protocol population: subjects must have no major protocol violations, must be seronegative to the relevant type at Day 1 and PCR negative to the relevant type through Month 7, and must provide data. Only subjects participating in a substudy had blood samples at Month 7.||Participants|||Number
704589|NCT00092534|Primary|Tolerability; Incidence of the Composite Endpoint of HPV 16 or HPV 18 Related CIN2/3 or Invasive Cervical Carcinoma After Completion of the Vaccination Series for Relevant HPV Type|"Tolerability = Number of subjected affected. Incidence Rate per person-years of follow-up.
The tolerability objective was to demonstrate that Gardasil is generally well tolerated by females aged 16-23. The relevant data are presented in the Reported Adverse Events section. No formal statistical hypothesis testing were performed for this objective."|Follow-up through end of study (4 years)|Per-protocol population: subjects must have no major protocol violations, must be seronegative to the relevant type at Day 1 and Polymerase chain reaction (PCR) negative to the relevant type through Month 7, and must provide follow-up data.||Incidence per 100 person-years|||Number
704590|NCT00092547|Secondary|Combined Incidence of HPV 6/11/16/18-related Persistent Infection and HPV 6/11/16/18-related PIN, Genital Warts, and Penile/Perineal/Perianal Cancer in Males|The HPV types were determined by PCR testing. Combined incidence of HPV 6/11/16/18-related persistent infection and HPV 6/11/16/18-related penile/perineal/perianal intraepithelial neoplasia (PIN), genital warts, and penile/perineal/perianal cancer was assessed in male participants.|Up to Month 126|Per-Protocol Effectiveness population: male participants without protocol violations who received at least 1 dose of qHPV vaccine and at least 1 effectiveness follow-up visit.||Cases per 100 person-years at risk||95% Confidence Interval|Number
704591|NCT00092547|Secondary|Combined Incidence of HPV 6/11/16/18-related Persistent Infection and HPV 6/11/16/18-related CIN, AIS, VIN, VaIN, Genital Warts, and Cervical/Vaginal/Vulvar Cancer in Females|The HPV types were determined by polymerase chain reaction (PCR) testing. The combined incidence of HPV 6/11/16/18-related persistent infection and HPV 6/11/16/18-related cervical intraepithelial neoplasia (CIN), adenocarcinoma in situ (AIS), vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VaIN), genital warts, and cervical/Vaginal/vulvar cancer was assessed in female participants.|Up to Month 126|Per-Protocol Effectiveness population: male participants without protocol violations who received at least 1 dose of qHPV vaccine and at least 1 effectiveness follow-up visit.||Cases per 100 person-years at risk||95% Confidence Interval|Number
704592|NCT00092547|Secondary|Geometric Mean Titers in the Extension Group for Anti-HPV 6, 11, 16, and 18 at Month 1 Postdose 3 of qHPV Vaccine (Month 37)||Month 37 (1 Month Post-dose 3 of qHPV)|Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations within appropriate day ranges, were seronegative to the respective HPV type at Month 30, and had a valid serology result at the specified time for assessment.||milliMerck units/mL||95% Confidence Interval|Geometric Mean
704593|NCT00092547|Secondary|Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 31 Postdose 3 of qHPV Vaccine (Month 37)||Month 37 (31 Months Post-dose 3)|Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment.||milliMerck units/mL||95% Confidence Interval|Geometric Mean
704594|NCT00092547|Secondary|Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 24 Postdose 3 of qHPV Vaccine (Month 30)||Month 30 (24 Months Post-dose 3)|Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment.||milliMerck units/mL||95% Confidence Interval|Geometric Mean
704658|NCT00093470|Secondary|Overall Survival|Overall survival (OS) is defined as the time from randomization to death from any cause.|Assessed monthly for the first 6 months then every 3 months or as clinically indicated, up to 5 years.|All randomized patients||months||95% Confidence Interval|Median
704595|NCT00092547|Secondary|Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 18 Postdose 3 of qHPV Vaccine (Month 24)||Month 24 (18 Months Post-dose 3)|Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment.||milliMerck units/mL||95% Confidence Interval|Geometric Mean
704596|NCT00092547|Secondary|Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 12 Postdose 3 of qHPV Vaccine (Month 18)||Month 18 (Month 12 Post-dose 3)|Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment.||milliMerck units/mL||95% Confidence Interval|Geometric Mean
704597|NCT00092547|Secondary|Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 1 Postdose 3 of qHPV Vaccine (Month 7)||Month 7 (1 Month Post-dose 3)|Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment.||milliMerck units/mL||95% Confidence Interval|Geometric Mean
704598|NCT00092547|Secondary|Percentage of Participants in the Extension Group Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 1 Postdose 3 of qHPV (Month 37)|A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.|Month 37 (1 Month Post-dose 3 of qHPV)|Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Month 30, and had a valid serology result at the specified time for assessment.||Percentage of participants||95% Confidence Interval|Number
704599|NCT00092547|Secondary|Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 31 Postdose 3 (Month 37).|A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.|Month 37 (31 Months Post-dose 3)|Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment.||Percentage of participants||95% Confidence Interval|Number
704600|NCT00092547|Secondary|Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 24 Postdose 3 (Month 30)|A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.|Month 30 (24 Months Post-dose 3)|Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment.||Percentage of participants||95% Confidence Interval|Number
704601|NCT00092547|Secondary|Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 18 Postdose 3 (Month 24)|A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.|Month 24 (18 Months Post-dose 3)|Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment.||Percentage of participants||95% Confidence Interval|Number
704602|NCT00092547|Secondary|Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 12 Postdose 3 (Month 18).|A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.|Month 18 (12 Months Post-dose 3)|Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment.||Percentage of participants||95% Confidence Interval|Number
704603|NCT00092547|Secondary|Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 1 Postdose 3 (Month 7)|A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.|Month 7 (1 Month Postdose 3)|Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment.||Percentage of participants||95% Confidence Interval|Number
704604|NCT00092547|Primary|Number of Participants Reporting SAEs Related to Study Vaccine or to a Study Procedure in the Long-term Follow-up|"A serious adverse event is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an other important medical event based on medical judgment. SAEs considered by the investigator to be possibly, probably, or definitely related to study vaccine or a study procedure were reported."|Month 37 to Month 126|The analysis population was all participants who were vaccinated according to actual treatment received and had safety follow-up.||Participants|||Number
704605|NCT00092547|Primary|Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 126|A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.|Month 126 (120 Months Post-dose 3 for Original qHPV Vaccine Cohort and 90 Months Post-dose 3 for Extension Group)|Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1 (for the Main Vaccination group), or Month 30 (for the Extension Group), and had a valid serology result at the specified time for assessment.||Percentage of participants||95% Confidence Interval|Number
704606|NCT00092547|Primary|Geometric Mean Titers for Anti-HPV 6, 11, 16, and 18 at Month 126||Month 126 (120 Months Post-dose 3 for Original qHPV Vaccine Cohort and 90 Months Post-dose 3 for Extension Group)|Per-protocol population: participants without protocol violations who received all 3 vaccinations within appropriate day ranges as defined in the CSR, were seronegative to the respective HPV type at Day 1 (for the Main Vaccination group), or Month 30 (for the Extension Group), and had a valid serology result at the specified time for assessment.||milliMerck units/mL||95% Confidence Interval|Geometric Mean
704607|NCT00092547|Primary|Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 96|A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.|Month 96 (90 Months Post-dose 3 for Original qHPV Vaccine Cohort and 60 Months Post-dose 3 for Extension Group)|Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1 (for the Main Vaccination group), or Month 30 (for the Extension Group), and had a valid serology result at the specified time for assessment.||Percentage of participants||95% Confidence Interval|Number
704608|NCT00092547|Primary|Geometric Mean Titers for Anti-HPV 6, 11, 16, and 18 at Month 96||Month 96 (90 Months Post-dose 3 for Original qHPV Vaccine Group and 60 Months Post-dose 3 for Extension Group)|Per-protocol population: participants without protocol violations who received all 3 vaccinations within appropriate day ranges as defined in the CSR, were seronegative to the respective HPV type at Day 1 (for the Main Vaccination group), or Month 30 (for the Extension Group), and had a valid serology result at the specified time for assessment.||milliMerck units/mL||95% Confidence Interval|Geometric Mean
704609|NCT00092547|Primary|Geometric Mean Titers (GMTs) for Anti-HPV 6, 11, 16, and 18 at Month 72||Month 72 (66 Months Post-dose 3 for the Original qHPV Vaccine Cohort and 36 months Post-dose 3 for the Extension Group)|Per-protocol population: participants without protocol violations who received all 3 vaccinations within appropriate day ranges as defined in the CSR, were seronegative to the respective HPV type at Day 1 (for the Main Vaccination group), or Month 30 (for the Extension Group), and had a valid serology result at the specified time for assessment.||milliMerck units/mL||95% Confidence Interval|Geometric Mean
704610|NCT00092547|Primary|Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 72|A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.|Month 72 (66 Months Post-dose 3 for the Original qHPV Vaccine Cohort and 36 months Post-dose 3 for the Extension Group)|Per-protocol population: participants without protocol violations who received all 3 vaccinations, were seronegative to the respective HPV type at Day 1 (for the Base Vaccination group), or Month 30 (for the Extension Group), and had a valid serology result at the specified time for assessment.||Percentage of participants||95% Confidence Interval|Number
704611|NCT00092547|Primary|Number of Participants Reporting Other (Non-serious) AEs Through Month 18|Tolerability as assessed by the number of participants with clinical adverse experiences through Month 18|Up to Month 18: Injection site AEs were collected from Days 1-5 and other non-serious AEs from Days 1-15 after any vaccination|All participants who were vaccinated according to actual treatment received (qHPV or placebo) and had safety follow-up.||participants|||Number
704612|NCT00092547|Primary|Number of Participants Reporting SAEs From Month 18 Through Month 37|Tolerability as assessed by the number of participants with clinical adverse experiences from Month 18 through Month 37|Month 18 to Month 37|All participants who were vaccinated according to actual treatment received (qHPV or placebo) and had safety follow-up.||participants|||Number
704613|NCT00092547|Primary|Number of Participants Reporting Serious Adverse Experiences (SAEs) Through Month 18|"Tolerability as assessed by the number of participants with clinical adverse experiences through Month 18. A serious adverse event is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an other important medical event based on medical judgment."|Up to Month 18|All participants who were vaccinated according to actual treatment received (qHPV or placebo) and had safety follow-up.||participants|||Number
704614|NCT00092677|Other Pre-specified|Percent Change in Time Weighted Average Triglycerides From Baseline to End of Follow-up|Mean percent change (time-weighted average over follow-up) from baseline: Time-weighted average calculated using values at week 8, week 24, year 1 and every 6 months with time interval (days) between 2 successive values used as the weighting factor. For the first follow-up value, the weight was the number of days from randomization.|Baseline to End of follow-up (median = 4.35 years)|Full Analysis Set: All patients who were randomized, took at least one dose of blinded study therapy and had a baseline and at least one post-randomization assessment without regard to protocol violations or compliance with study medication.||Percent Change||Standard Deviation|Mean
704615|NCT00092677|Other Pre-specified|Percent Change in Time Weighted Average High-density Lipoprotein Cholesterol (HDL-C) From Baseline to End of Follow-up|Mean percent change (time-weighted average over follow-up) from baseline: Time-weighted average calculated using values at week 8, week 24, year 1 and every 6 months with time interval (days) between 2 successive values used as the weighting factor. For the first follow-up value, the weight was the number of days from randomization.|Baseline to End of follow-up (median = 4.35 years)|Full Analysis Set: All patients who were randomized, took at least one dose of blinded study therapy and had a baseline and at least one post-randomization assessment without regard to protocol violations or compliance with study medication.||Percent change||Standard Deviation|Mean
704616|NCT00092677|Other Pre-specified|Percent Change in Time Weighted Average Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to End of Follow-up|Mean percent change (time-weighted average over follow-up) from baseline: Time-weighted average calculated using values at week 8, week 24, year 1 and every 6 months with time interval (days) between 2 successive values used as the weighting factor. For the first follow-up value, the weight was the number of days from randomization.|Baseline to End of follow-up (median = 4.35 years)|Full Analysis Set: All patients who were randomized, took at least one dose of blinded study therapy and had a baseline and at least one post-randomization assessment without regard to protocol violations or compliance with study medication.||Percent Change||Standard Deviation|Mean
704617|NCT00092677|Other Pre-specified|Percent Change in Time Weighted Average Total Cholesterol From Baseline to End of Follow-up|Mean percent change (time-weighted average over follow-up) from baseline: Time-weighted average calculated using values at week 8, week 24, year 1 and every 6 months with time interval (days) between 2 successive values used as the weighting factor. For the first follow-up value, the weight was the number of days from randomization.|Baseline to End of follow-up (median = 4.35 years)|Full Analysis Set: All patients who were randomized, took at least one dose of blinded study therapy and had a baseline and at least one post-randomization assessment without regard to protocol violations or compliance with study medication.||Percent Change||Standard Deviation|Mean
704618|NCT00092677|Secondary|Change From Baseline in Peak Transaortic Jet Velocity|Mean change from baseline in peak transaortic jet velocity|Baseline to End of follow-up (median = 4.35 years) or pre-aortic valve replacement|Full Analysis Set: All patients who were randomized, took at least one dose of blinded study therapy and had a baseline and at least one post-randomization assessment without regard to protocol violations or compliance with study medication. 180 patients were excluded from peak transaortic jet velocity due to missing measurements.||m/sec||Standard Deviation|Mean
704619|NCT00092677|Post-Hoc|Incident Cancer|Number of participants with incident cancer|Entire follow-up (median = 4.35 years)|One patient from the 944 patients randomized to ezetimibe/simvastatin 10/40 mg did not receive study medication and was not included.||Participants|||Number
704620|NCT00092677|Post-Hoc|Death Due to Cancer|Number of participants that died due to cancer|Entire follow-up (median = 4.35 years)|Intention-to-Treat||Participants|||Number
704621|NCT00092677|Other Pre-specified|Death (Any Cause)|Number of participants that died (any cause)|Entire follow-up (median = 4.35 years)|Intention-to-Treat||Participants|||Number
704622|NCT00092677|Other Pre-specified|Nonhemorrhagic Stroke|Number of participants that experienced nonhemorrhagic stroke|Entire follow-up (median = 4.35 years)|Intention-to-Treat||Participants|||Number
704623|NCT00092677|Other Pre-specified|Hospitalization for Unstable Angina|Number of participants that experienced hospitalization for unstable angina|Entire follow-up (median = 4.35 years)|Intention-to-Treat||Participants|||Number
704624|NCT00092677|Other Pre-specified|Percutaneous Coronary Intervention (PCI)|Number of participants that experienced percutaneous coronary intervention (PCI)|Entire follow-up (median = 4.35 years)|Intention-to-Treat||Participants|||Number
704625|NCT00092677|Other Pre-specified|Coronary Artery Bypass Grafting (CABG)|Number of participants that experienced coronary artery bypass grafting (CABG)|Entire follow-up (median = 4.35 years)|Intention-to-Treat||Participants|||Number
704626|NCT00092677|Other Pre-specified|Nonfatal Myocardial Infarction (MI)|Number of participants that experienced nonfatal myocardial infarction (MI)|Entire follow-up (median = 4.35 years)|Intention-to-Treat||Participants|||Number
704627|NCT00092677|Other Pre-specified|Congestive Heart Failure (CHF) Due to Progression of Aortic Stenosis (AS)|Number of participants that experienced Congestive Heart Failure (CHF) due to progression of aortic stenosis (AS)|Entire follow-up (median = 4.35 years)|Intention-to-Treat||Participants|||Number
704628|NCT00092677|Other Pre-specified|Aortic Valve Replacement (AVR)|Number of participants that experienced aortic valve replacement (AVR)|Entire follow-up (median = 4.35 years)|Intention-to-Treat||Participants|||Number
704629|NCT00092677|Other Pre-specified|Cardiovascular Death|Number of participants that experienced cardiovascular death|Entire follow-up (median = 4.35 years)|Intention-to-Treat||Participants|||Number
704630|NCT00092677|Secondary|Number of Participants That Experienced One or More Components of the Composite Clinical Endpoint of ICE (Ischemic Cardiovascular Events)|Composite endpoint of ICE (ischemic cardiovascular events) consists of cardiovascular death, nonfatal MI, CABG, PCI, hospitalized unstable angina, and nonhemorrhagic stroke|Entire follow-up (median = 4.35 years)|Intention-to-Treat||Participants|||Number
704631|NCT00092677|Secondary|Number of Participants That Experienced One or More Components of the Composite Clinical Endpoint of AVE (Aortic Valve Events)|Composite endpoint of AVE (aortic valve events) consists of AVR surgery, CHF (as a result of progression of AS), or cardiovascular death|Entire follow-up (median = 4.35 years)|Intention-to-Treat||Participants|||Number
704632|NCT00092677|Primary|Number of Participants That Experienced One or More Components of the Composite Clinical Endpoint of MCE (Major Cardiovascular Events)|Composite endpoint of MCE consists of cardiovascular death, AVR (aortic valve replacement) surgery, CHF(congestive heart failure) as a result of progression of aortic stenosis, nonfatal MI (myocardial infarction), CABG (coronary artery bypass) surgery, PCI (percutaneous coronary intervention), hospitalized unstable angina, and nonhemorrhagic stroke|Entire follow-up (median = 4.35 years)|Intention-to-Treat||Participants|||Number
704633|NCT00093015|Secondary|Time to Hospitalization Due to Acute Myocardial Ischemia|Time from randomization to hospitalization due to acute myocardial ischemia. Kaplan-Meier estimate of the median time was not estimable due to low proportion of participants experiencing at least one events, therefore participants experiencing at least one event were summarized.|Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first|The analysis followed intent-to-treat principles. Subjects were analyzed as randomized using all available follow-up information.||Participants|||Number
704634|NCT00093015|Secondary|Change in Patient Reported Fatigue Relative to Baseline at Week 25|Change in patient reported fatigue measured by the Functional Assessment of Cancer Therapy (FACT) – Fatigue scale from baseline to week 25. Range and direction of scale: 0 = most fatigue; 52 = least fatigue|Baseline and week 25|Subjects with both the baseline and at least post-baseline measurement at week 25 for FACT-fatigue were included in the analysis and were analyzed as randomized. Last observation carried forward (LOCF) using last non-missing post-baseline value was used for missing post-baseline data for subjects who were still on study.||Units on a scale||Standard Deviation|Mean
704659|NCT00093470|Primary|Disease-free Survival|Disease-free survival (DFS) is defined as the time from randomization to relapse or death without relapse.|Assessed monthly for the first 6 months then every 3 months or as clinically indicated, up to 5 years.|All randomized patients||months||95% Confidence Interval|Median
704709|NCT00094302|Secondary|Hospitalization for Any Reason|First incidence of a hospitalization for any reason|Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.||Events per 100 person-years|||Number
704635|NCT00093015|Secondary|Rate of Decline in Estimated Glomerular Filtration Rate (eGFR) Relative to Baseline|GFR was estimated using the following MDRD formula: 186 x [Serum creatinine]^(-1.154) x [Age]^(-0.203) x [0.742 if subject is female] x [1.210 if subject is black]. Change from baseline in eGFR at week 49 for each treatment group are presented. The treatment effect of the rate of decline in eGFR per year was estimated using the mixed model.|Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first|Subjects were analyzed as randomized using all available eGFR measurements, except eGFR measurements measured after subjects develop ESRD since creatinine measurements were no longer reliable or meaningful for eGFR calculation.||mL/min/1.73m^2||Standard Deviation|Mean
704636|NCT00093015|Secondary|Time to End Stage Renal Disease|Time from randomization to end stage renal disease (ESRD). Kaplan-Meier estimate of the median time was not estimable due to low proportion of participants experiencing at least one events, therefore participants experiencing at least one event were summarized.|Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first|The analysis followed intent-to-treat principles. Subjects were analyzed as randomized using all available follow-up information.||Participants|||Number
704637|NCT00093015|Secondary|Time to Congestive Heart Failure|Time from randomization to fatal or non-fatal congestive heart failure(CHF). Kaplan-Meier estimate of the median time was not estimable due to low proportion of participants experiencing at least one events, therefore participants experiencing at least one event were summarized.|Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first|The analysis followed intent-to-treat principles. Subjects were analyzed as randomized using all available follow-up information.||Participants|||Number
704638|NCT00093015|Secondary|Time to Cerebrovascular Accident|Time from randomization to fatal or non-fatal cerebrovascular accident (CVA). Kaplan-Meier estimate of the median time was not estimable due to low proportion of participants experiencing at least one events, therefore participants experiencing at least one event were summarized.|Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first|The analysis followed intent-to-treat principles. Subjects were analyzed as randomized using all available follow-up information.||Participants|||Number
704639|NCT00093015|Secondary|Time to Myocardial Infarction|Time from randomization to fatal or non-fatal myocardial infarction (MI). Kaplan-Meier estimate of the median time was not estimable due to low proportion of participants experiencing at least one events, therefore participants experiencing at least one event were summarized.|Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first|The analysis followed intent-to-treat principles. Subjects were analyzed as randomized using all available follow-up information.||Participants|||Number
704640|NCT00093015|Secondary|Time to Cardiovascular Mortality|Time from randomization to cardiovascular (CV) mortality. Kaplan-Meier estimate of the median time was not estimable due to low proportion of participants experiencing at least one events, therefore participants experiencing at least one event were summarized.|Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first|The analysis followed intent-to-treat principles. Subjects were analyzed as randomized using all available follow-up information.||Participants|||Number
704641|NCT00093015|Secondary|Time to All-cause Mortality|Time from randomization to all-cause mortality. Kaplan-Meier estimate of the median time was not estimable due to low proportion of participants experiencing at least one events, therefore participants experiencing at least one event were summarized.|Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first|The analysis followed intent-to-treat principles. Subjects were analyzed as randomized using all available follow-up information.||Participants|||Number
704642|NCT00093015|Primary|Time to All-cause Mortality or End Stage Renal Disease (ESRD)|Time from randomization to first event of all-cause mortality or ESRD. Kaplan-Meier estimate of the median time was not estimable due to low proportion of participants experiencing at least one events, therefore participants experiencing at least one event were summarized.|Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first|The analysis followed intent-to-treat principles. Subjects were analyzed as randomized using all available follow-up information.||Participants|||Number
704643|NCT00093015|Primary|Time to All-cause Mortality or Cardiovascular (CV) Events Including Hospitalization Due to Acute Myocardial Ischemia, Congestive Heart Failure (CHF), Myocardial Infarction (MI), and Cerebrovascular Accident (CVA)|Time from randomization to the first confirmed composite event. Kaplan-Meier estimate of the median time was not estimable due to low proportion of participants experiencing at least one events, therefore participants experiencing at least one event were summarized.|Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first|The analysis followed intent-to-treat principles. Subjects were analyzed as randomized using all available follow-up information.||Participants|||Number
704644|NCT00093041|Secondary|Overall Response, Classification|Overall response was evaluated according to RECIST J Natl Cancer Inst 2000;92:205-16.|8 weeks|||participants|||Number
704645|NCT00093041|Primary|Adverse Events|Number of participants reporting at least one adverse event|Overall Study|Number of participants reporting at least one adverse event||participants|||Number
704660|NCT00093496|Secondary|Toxicity|Defined by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 as an adverse event classified as either possibly, probably, or definitely related to study treatment. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns.|Participants were evaluated every 6 weeks on treatment (maximum 42 weeks)|In Cohort 1, one patient was found to be ineligible. In Cohort 2, one patient was ineligible and two patients had protocol violations. Therefore, 14 participants in Cohort 1 and eleven participants in Cohort 2 were analyzed for adverse events.||events|||Number
704646|NCT00093145|Secondary|Number of Participants With Adverse Events (AEs)|A Treatment-emergent AE was any AE that began or worsened after the start of study drug through 30 days after the last dose of study drug or end of study whichever is later. A treatment related toxicity was one considered by the investigator to be possibly, probably or definitely related to study drug. AEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events v3.0 (CTCAE) on the following scale: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening, Grade 5 = death. A serious adverse event (SAE) is any untoward medical occurrence at any dose that: is fatal or life-threatening; results in persistent or significant disability or incapacity; requires or prolongs in-patient hospitalization; is a congenital anomaly/birth defect in the offspring of a patient; and conditions not included in the above that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above|Day 1 up to 39 cycles|Treated population||participants|||Number
704647|NCT00093145|Secondary|Overall Patient Survival|Overall survival was defined as the time from the day of randomization to patient death (due to any cause), as assessed by post study follow-up on a monthly basis for 3 months and every 3 months. Participants still alive were censored at the last known time that the patient was alive. Patient survival was estimated using Kaplan-Meier methods.|From Day 1 until approximately 44 months.|Treated population||months||95% Confidence Interval|Median
704648|NCT00093145|Secondary|Duration of Response|Duration of response was evaluated by measuring progression-free survival for participants with a complete response or partial response. Progression-free survival was defined as the time from the first dose of study drug to the start of progression or patient death (whichever occurred first). Participants who did not have progression or were still alive were censored at the last known time the patient was progression free. Patients that initiated other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated. Progression is at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of the longest diameters recorded since the treatment started; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion.|Assessed every 2 cycles, up to a maximum of 39 cycles.|Treated Population - Patients with a Confirmed Complete or Partial Overall Response||months||95% Confidence Interval|Median
704649|NCT00093145|Secondary|Time to Disease Progression|Time to disease progression was measured from the date of first dose of study drug to the start of disease progression. Patients who did not have disease progression at the end of follow-up were censored at the last known time that the patient was evaluated for progression. Progression is at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of the longest diameters recorded since the treatment started; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion. Time to disease progression was summarized using Kaplan-Meier methods.|Assessed every 2 cycles, up to a maximum of 39 cycles.|Treated population||months||95% Confidence Interval|Median
704650|NCT00093145|Secondary|Percentage of Participants With a Total Response|Total response was defined as the percentage of participants with stable disease (SD) for ≥ 16 weeks or complete or partial overall response. Stable disease was defined as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease. Progressive disease is at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of the longest diameters recorded since the treatment started; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion.|Evaluated every 2 cycles, up to a maximum of 39 cycles.|Treated population||percentage of participants||95% Confidence Interval|Number
704651|NCT00093145|Primary|Percentage of Participants Who Achieved an Objective Confirmed Complete or Partial Overall Response|Percentage of participants who achieved an objective confirmed complete or partial overall response based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. A complete response (CR) is the disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation. A partial response (PR) is at least a 30% decrease in the sum of the longest diameters of target lesions, taking as a reference the baseline sum of the longest diameters confirmed at least 4 weeks after initial documentation. PR is also recorded when all measurable disease has completely disappeared, but a non-measurable component (i.e., ascites) is still present but not progressing, or with the persistence of one or more non-target lesions and/or the maintenance of tumor marker level above the normal limits.|Objective response was evaluated every 2 cycles, up to a maximum of 39 cycles (approximately 39 months)|The treated population consisted of all randomized participants who received at least one dose of study drug.||Percentage of participants||95% Confidence Interval|Number
704652|NCT00093379|Secondary|Number of Participants With Progression-Free Survival at 2-Year||2 Years||||||
704653|NCT00093379|Secondary|2-Year Median Overall Survival||2 Years||||||
704654|NCT00093379|Secondary|2-year Local Regional Control||2 Years||||||
704655|NCT00093379|Secondary|Number of Participants With 2-year Colostomy-Free Survival|Colostomy-free survival reported as number of participants who did not develop local recurrence or require salvage resection with colostomy.|2 Years with median study follow up of 19 months|||participants|||Number
704656|NCT00093379|Secondary|Number of Participants With Complete Response at 2 Years|Response determined by computed tomography (CT)/magnetic resonance imaging (MRI), digital rectal examination, and proctoscopy, and a biopsy performed for clinical suspicion of residual or progressive disease. Response Evaluation Criteria in Solid Tumors (RECIST) where evaluation of target lesions Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|2 Years|Three (3) participants were not evaluable for response.||participants|||Number
704657|NCT00093379|Primary|2 Year Failure Free Survival|Treatment failure defined as: Biopsy proven residual disease identified 12 –14 weeks after the conclusion of chemoradiation therapy, Treatment-related mortality or Disease recurrence.|2 years|||participants|||Number
704756|NCT00100698|Secondary|Change in Adiponectin|Change in adiponectin|18 months|||mcg/mL||Standard Error|Mean
704661|NCT00093496|Secondary|Overall Survival|Defined as the time from registration to date of last follow-up or death due to any cause. Estimated using the method of Kaplan-Meier.|Every 3 months until disease progression and then every 6 months for up to 5 years.|An interim analysis was done on the first 12 eligible participants in each cohort. Due to drug shortage and lack of clinical acttivity, the interim analysis for Cohort 2 was conducted on the first 11 participants.||months||95% Confidence Interval|Median
704662|NCT00093496|Secondary|Times to Progression|Defined as the time from registration to the date of progression or last follow-up, whichever comes first. Estimated using the method of Kaplan-Meier|Participants were evaluated every 6 weeks on treatment (maximum 42 weeks), and followed up to 5 years from registration.|An interim analysis was done on the first 12 eligible participants in each cohort. Due to drug shortage and lack of clinical activity, the interim analysis for Cohort 2 was conducted on the first 11 participants.||months||95% Confidence Interval|Median
704663|NCT00093496|Primary|Proportion of Patients Who Experience a Confirmed Response According to Modified RECIST Criteria.|"Objective response will be measured using the modified RECIST criteria. A confirmed response requires an objective status of complete or partial response on 2 consecutive evaluations occurring 4 or more weeks apart.
Complete Response (CR): Disappearance of all target lesions and normalization of tumor biomarkers.
Partial Response (PR): At least a 30% decrease in the sum of the target lesions from the baseline."|Participants were evaluated every 6 weeks on treatment, with median treatment length of 12 weeks (3 week minimum and 42 week maximum).|In Cohort 1, one patient was found to be ineligible. In Cohort 2, one patient was ineligible and two patients had protocol violations. Therefore, 14 participants in Cohort 1 and eleven participants in Cohort 2 were analyzed for the primary endpoint.||proportion of participants|||Number
704664|NCT00093756|Secondary|Frequency and Severity of Observed Toxicity, Graded by Common Terminology Criteria for Adverse Events (CTCAE)||Up to 5 years||||||
704665|NCT00093756|Secondary|Survival Time|The distribution of survival time will be estimated using the method of Kaplan-Meier.|From registration to death due to any cause, up to 5 years||||||
704666|NCT00093756|Secondary|Progression-free Survival|The distribution of progression-free survival will be estimated using the method of Kaplan-Meier.|From study registration to the first of either death due to any cause or progression, up to 5 years||||||
704667|NCT00093756|Secondary|Time to Progression|The distribution of time to progression will be estimated > using the method of Kaplan-Meier.|From study registration to date of disease progression or date of last follow-up, up to 5 years||||||
704668|NCT00093756|Secondary|Confirmed Tumor Response, Defined as a Complete or Partial Response Noted as the Objective Status on 2 Consecutive Evaluations at Least 4 Weeks Apart||Up to 5 years||||||
704669|NCT00093756|Primary|The Primary Endpoint of This Trial is the Proportion of Patients Alive at 1 Year. Phase II Patients Only.|The primary endpoint of this trial is the proportion of patients alive at 1 year (i.e., 365 days) after study registration. Proportion of successes, defined as the number of patients alive at one year divided by the total number of evaluable patients.|At 1 year|Phase II patients are eligible for Primary end point.||percentage of Participants|||Number
704670|NCT00093782|Secondary|Time to Progression||Up to 8 years|At the time of publication, 5 patients were still on treatment and analysis was done on 31 patients||months||95% Confidence Interval|Median
704671|NCT00093782|Secondary|Number of Temsirolimus Treatment Cycle Analyzed for Toxicity|Safety and tolerability of treatment with Temsirolimus assessed using CTCAE v 3|Duration of participants treatment upto 16wks (4cycles) of treatment|||treatment cycles|||Number
704672|NCT00093782|Secondary|Response and Stable Disease|Assessed using RECIST criteria.Patients that had Stable disease for 2 months|2 months|Number of patients that had stable disease for 2 months||patients|||Number
704673|NCT00093782|Secondary|Survival Rate|Computed using the Kaplan-Meier method.|1 year|Out of the 25 patients alive as of Jan 2006||percentage of participants||95% Confidence Interval|Number
704674|NCT00093782|Secondary|Median Survival Time|Computed using the Kaplan-Meier method.|3|Out of the 25 patients alive (in 2006 at time of publication)||months||95% Confidence Interval|Median
704675|NCT00093782|Secondary|Stable Disease Rate Defined by RECIST Criteria|Potential association between variables will be measured using Pearson correlation coefficients, chi-square tests, one- or two-sample t-tests or logistic regression analyses as appropriate. Ninety-five percent confidence intervals will be constructed and selected results will be illustrated using figures and plots.|Up to 8 years|||participants|||Number
704676|NCT00093782|Primary|Objective Tumor Response Rate (Defined as Partial or Complete Response as Defined by the RECIST Criteria)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 8 years|||participants|||Number
704677|NCT00093808|Secondary|Overall Survival as Assessed by Time|Overall survival: The overall survival or survival time is defined as the time from registration to death due to any cause. The distribution of overall survival will be estimated using the method of Kaplan-Meier method.|Up to 5 years|Patients who completed the study or deemed a protocol violation were included in all analyses unless otherwise specified.||months||95% Confidence Interval|Median
704678|NCT00093808|Secondary|Duration of Response as Measured by RECIST Criteria|Duration of response is defined for all eligible patients who have achieved an objective response as the date at which the patient’s objective status is first noted to be either a Complete Response (CR) or Partial Response (PR) to the date progression is documented. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.|Up to 5 years|Patients who completed the study or deemed a protocol violation were included in all analyses unless otherwise specified.||months||95% Confidence Interval|Median
704708|NCT00094302|Secondary|Potassium|Average post-baseline Potassium, taking into consideration baseline Potassium, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.|Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.||mEq/L||Standard Error|Least Squares Mean
704679|NCT00093808|Secondary|Time to Progression (TTP)|Time to progression is defined as the time from registration to disease progression. Patients who died without documentation of progression will be considered to have progressed on the date of their death. If a patient starts treatment and fails to return for any evaluations, that patient will be censored for progression of disease at day one post-registration. Otherwise, for patients that do not progress, censoring will occur at the last follow up date. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions or unequivocal progression of existing non-target lesions.|Up to 5 years|Patients who completed the study or deemed a protocol violation were included in all analyses unless otherwise specified.||months||95% Confidence Interval|Median
704680|NCT00093808|Primary|Confirmed Response Rate|A confirmed tumor response is defined to be either a Complete Response (CR) or Partial Response (PR) noted as the objective status on 2 consecutive evaluations at least 6 weeks apart. All patients meeting the eligibility criteria who have signed a consent form and initiated study medication will be evaluable for response. The proportion of confirmed tumor responses will be estimated by the number of tumor regressions that meet the RECIST criteria for a confirmed CR or PR divided by the total number of evaluable patients. A 95% confidence interval for the true confirmed response rate will be calculated using the properties of the binomial distribution. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 5 years|Patients who completed the study were included in all analyses unless otherwise specified.||proportion of patients||95% Confidence Interval|Number
704681|NCT00093847|Secondary|HDRS17 Responders|35.8% versus 11.7%. Response is defined as a 50 percent or more score reduction on on Hamilton Depression Rating Scale 17 item .|Measured at Week 6|ITT LOCF||Percentage of Responders HDRS17|||Number
704682|NCT00093847|Primary|Hamilton Depression Rating Scale Remission Rates|The proportion of remitters for SAMe versus placebo was 46.1% versus 17.6%. Remission is defined as a final score of 7 or less on Hamilton Depression Rating Scale 17 item .|Measured at Week 6|ITT LOCF||Percentage of Remitters HDRS17|||Number
704683|NCT00094055|Other Pre-specified|Plasma Concentrations of Soluble Proteins|Plasma concentrations of soluble proteins (vascular endothelial growth factor [VEGF], placental growth factor [PlGF] and soluble vascular endothelial growth factor receptor-2 [sVEGFR2]) may be associated with tumor angiogenesis or tumor physiology and may correlate with efficacy or biological activity. It is presented as ratio to baseline, which is obtained by dividing the plasma soluble protein concentration at each time point by its concentration at baseline.|Day 1 (pre-dose) and then every 8 weeks up to 206 weeks|Ratio to baseline values for plasma soluble proteins were not summarized as descriptive statistics since the data was not available for the single study and data for all the axitinib Phase 2 studies would be pooled together in a separate report.||Ratio||Standard Deviation|Mean
704684|NCT00094055|Other Pre-specified|Population Pharmacokinetics for Axitinib (AG-013736) Plasma Concentrations|Population pharmacokinetic analysis involved mixed effects modeling using nonlinear mixed effects modeling (NONMEM) software. The intent of this analysis was to establish a basic population pharmacokinetic model for axitinib (AG-013736) and to determine inter-individual and residual variability in population (oral) clearance, and volume of distribution of drug. Relationship of demographic variables (gender, age, body weight, height and ethnicity), concomitant medications and measures of altered hepatic and renal function were examined by fitting measured axitinib (AG-013736) concentrations.|Day 1 (pre-dose), Day 29, Day 57 and then every 8 weeks up to 206 weeks|Population pharmacokinetic values were not summarized as descriptive statistics since the data was not available for the single study and data for all the axitinib (AG-013736) Phase 2 studies would be pooled together in a separate report.||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
704685|NCT00094055|Secondary|Overall Survival (OS)|Time in days from the start of study treatment to date of death due to any cause. OS was calculated as the death date minus the date of first dose of study medication plus 1. Death was determined from AE data (where outcome was death) or from follow-up contact data (where the participant current status was death). For participants who were alive, overall survival was censored at the last contact.|Baseline to death due to any cause or at least 1 year after the initial dose for the last treated participant|ITT population included all participants who received at least 1 dose of study medication.||Days||95% Confidence Interval|Median
704686|NCT00094055|Secondary|Duration of Response (DR)|Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Baseline to disease progression or discontinuation from study due to any cause, assessed every 8 weeks up to 206 weeks|Subgroup of participants from the ITT population with a confirmed objective tumor response (CR or PR).||Days||95% Confidence Interval|Median
704687|NCT00094055|Secondary|Progression-Free Survival (PFS)|"Time in days from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1). Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Baseline to disease progression or death due to any cause, assessed every 8 weeks up to 206 weeks|ITT population included all participants who received at least 1 dose of study medication.||Days||95% Confidence Interval|Median
704688|NCT00094055|Primary|Percentage of Participants With Objective Response (OR)|Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed response are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 206 weeks|Intent to treat (ITT) population included all participants who received at least 1 dose of study medication.||Percentage of participants||95% Confidence Interval|Number
704689|NCT00094094|Other Pre-specified|Plasma Concentrations of Soluble Proteins|Plasma concentrations of soluble proteins (vascular endothelial growth factor [VEGF], placental growth factor [PlGF] and soluble vascular endothelial growth factor receptor-2 [sVEGFR2]) may be associated with tumor angiogenesis or tumor physiology and may correlate with efficacy or biological activity. It is presented as ratio to baseline, which is obtained by dividing the plasma soluble protein concentration at each time point by its concentration at baseline.|Day 1 (pre-dose) and then every 8 weeks up to 98 weeks|Ratio to baseline values for plasma soluble proteins were not summarized as descriptive statistics since the data was not available for the single study and data for all the axitinib Phase 2 studies would be pooled together in a separate report.||Ratio||Standard Deviation|Mean
704690|NCT00094094|Other Pre-specified|Population Pharmacokinetics for Axitinib (AG-013736) Plasma Concentrations|Population pharmacokinetic analysis involved mixed effects modeling using nonlinear mixed effects modeling (NONMEM) software. The intent of this analysis was to establish a basic population pharmacokinetic model for axitinib (AG-013736) and to determine inter-individual and residual variability in population (oral) clearance, and volume of distribution of drug. Relationship of demographic variables (gender, age, body weight, height and ethnicity), concomitant medications and measures of altered hepatic and renal function were examined by fitting measured axitinib (AG-013736) concentrations.|Day 1 (pre-dose), Day 29, Day 57 and then every 8 weeks up to 98 weeks|Population pharmacokinetic values were not summarized as descriptive statistics since the data was not available for the single study and data for all the axitinib Phase 2 studies would be pooled together in a separate report.||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
704691|NCT00094094|Secondary|Overall Survival (OS)|Time in days from the start of study treatment to date of death due to any cause. OS was calculated as the death date minus the date of first dose of study medication plus 1. Death was determined from AE data (where outcome was death) or from follow-up contact data (where the participant current status was death). For participants who were alive, overall survival was censored at the last contact.|Baseline to death due to any cause or at least 1 year after the initial dose for the last treated participant|Study population included all participants who enrolled and received treatment.||Days||95% Confidence Interval|Median
704692|NCT00094094|Secondary|Duration of Response (DR)|Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 98 weeks|Subgroup of participants from the study population with a confirmed objective tumor response (CR or PR).||Days||95% Confidence Interval|Median
704693|NCT00094094|Secondary|Progression-Free Survival (PFS)|"Time in days from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as first event date minus the date of first dose of study medication plus 1. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Baseline until the date of first documented progression or death due to any cause, assessed every 8 weeks up to 98 weeks|Study population included all participants who enrolled and received treatment.||Days||95% Confidence Interval|Median
704694|NCT00094094|Primary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 98 weeks|Study population included all participants who enrolled and received treatment.||Percentage of participants||95% Confidence Interval|Number
704695|NCT00094107|Other Pre-specified|Plasma Concentrations of Soluble Proteins|Plasma concentrations of soluble proteins (vascular endothelial growth factor [VEGF], placental growth factor [PlGF] and soluble vascular endothelial growth factor receptor-2 [sVEGFR2]) may be associated with tumor angiogenesis or tumor physiology and may correlate with efficacy or biological activity. It is presented as ratio to baseline, which is obtained by dividing the plasma soluble protein concentration at each time point by its concentration at baseline.|Day 1 (pre-dose) and then every 8 weeks up to 147 weeks|Ratio to baseline values for plasma soluble proteins were not summarized as descriptive statistics since the data was not available for the single study and data for all the axitinib Phase 2 studies would be pooled together in a separate report.||Ratio||Standard Deviation|Mean
704696|NCT00094107|Other Pre-specified|Population Pharmacokinetics for Axitinib (AG-013736) Plasma Concentrations|Population pharmacokinetic analysis involved mixed effects modeling using nonlinear mixed effects modeling (NONMEM) software. The intent of this analysis was to establish a basic population pharmacokinetic model for axitinib (AG-013736) and to determine inter-individual and residual variability in population (oral) clearance, and volume of distribution of drug. Relationship of demographic variables (gender, age, body weight, height and ethnicity), concomitant medications and measures of altered hepatic and renal function were examined by fitting measured axitinib (AG-013736) concentrations.|Day 1 (pre-dose), Day 29, Day 57 and then every 8 weeks up to 147 weeks|Population pharmacokinetic values were not summarized as descriptive statistics since the data was not available for the single study and data for all the axitinib (AG-013736) Phase 2 studies would be pooled together in a separate report.||ng/mL||Standard Deviation|Mean
704697|NCT00094107|Secondary|Overall Survival (OS)|Time in days from the start of study treatment to date of death due to any cause. OS was calculated as the death date minus the date of first dose of study medication plus 1. Death was determined from AE data (where outcome was death) or from follow-up contact data (where the participant current status was death). For participants who were alive, overall survival was censored at the last contact.|Baseline to death due to any cause or at least 1 year after the initial dose for the last treated participant|Study population included all participants who received at least 1 dose of study medication.||Days||95% Confidence Interval|Median
704757|NCT00100698|Secondary|Change in Diastolic Blood Pressure|Change in diastolic blood pressure|18 months|||mm Hg||Standard Error|Mean
704698|NCT00094107|Secondary|Duration of Response (DR)|Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 147 weeks|Subgroup of participants from the study population with a confirmed objective tumor response (CR or PR).||Days||95% Confidence Interval|Median
704699|NCT00094107|Secondary|Progression-free Survival (PFS)|"Time in days from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as first event date minus the date of first dose of study medication plus 1. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Baseline until the date of first documented progression or death due to any cause, assessed every 8 weeks up to 147 weeks|Study population included all participants who received at least 1 dose of study medication and had at least one baseline efficacy assessment.||Days||95% Confidence Interval|Median
704700|NCT00094107|Primary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 147 weeks|Study population included all participants who received at least 1 dose of study medication and had at least one baseline efficacy assessment.||Percentage of participants||95% Confidence Interval|Number
704701|NCT00094172|Secondary|Proportion of Participants Diagnosed With Multiple Sclerosis According to the McDonald Criteria|"Number of participants diagnosed with Multiple Sclerosis (MS) according to the McDonald criteria[1]
The McDonald criteria uses dissemination in time and space[2] established by Magnetic Resonance Image (MRI) findings to provide a clinical diagnosis for MS
Dissemination in time is established by a new T2 or gadolinium-enhancing (Gd+) lesion found on a repeat MRI. The presence of any 3 of the following establishes dissemination in space: 1 Gd+ lesion or 9 T2 bright lesions if there is no enhancement; ≥1 infratentorial lesion; ≥1 juxtacortical lesion; ≥3 periventricular lesions"|18 months post-randomization|Intent-to-Treat||Participants|||Number
704702|NCT00094172|Secondary|Proportion of Participants Who Are Diagnosed With Multiple Sclerosis According to the McDonald Criteria|"Number of participants diagnosed with Multiple Sclerosis (MS) according to the McDonald criteria[1]
The McDonald criteria uses dissemination in time and space[2] established by Magnetic Resonance Image (MRI) findings to provide a clinical diagnosis for MS
Dissemination in time is established by a new T2 or gadolinium-enhancing (Gd+) lesion found on a repeat MRI. The presence of any 3 of the following establishes dissemination in space: 1 Gd+ lesion or 9 T2 bright lesions if there is no enhancement; ≥1 infratentorial lesion; ≥1 juxtacortical lesion; ≥3 periventricular lesions"|12 months post-randomization|Intent-to-Treat||Participants|||Number
704703|NCT00094172|Primary|The Occurrence of ≥ 3 New T2 Lesions With or Without Gd+ Enhancement or Clinical Exacerbation Through 12 Months.|"The occurrence of ≥ T2 lesions[1] with or without gadolinium lesion (Gd+) enhancement[2] or clinical exacerbation[3] through 12 months. A higher score indicates more severe disease
A new T2 lesion is an abnormal, hyperintense white-matter area visible on T2 weighted images that were not present on the baseline scan
A Gd+ enhancement is defined as a contrast enhancement visible on a new T2 lesion
A clinical exacerbation is a new neurological symptom that lasts more than 48 hours in a participant who has been neurologically stable for 30 days following start of study medication"|12 months post-randomization|Intent-to-Treat||Participants|||Number
704704|NCT00094302|Secondary|Estimated Glomerular Filtration Rate (GFR)|Average post-baseline GFR, taking into consideration baseline GFR, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.|Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.||mL/min/1.73m2||Standard Error|Least Squares Mean
704705|NCT00094302|Secondary|Chloride|Average post-baseline Chloride, taking into consideration baseline Chloride, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.|Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.||mEq/L||Standard Error|Least Squares Mean
704706|NCT00094302|Secondary|Sodium|Average post-baseline Sodium, taking into consideration baseline Sodium, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.|Randomization through each subject’s last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.||mEq/L||Standard Error|Least Squares Mean
704707|NCT00094302|Secondary|Serum Creatinine|Average post-baseline serum creatinine, taking into consideration baseline serum creatinine, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.|Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.||mg/dL||Standard Error|Least Squares Mean
706066|NCT00104637|Primary|VO2 Peak (Oxygen Consumption at Peak Exercise)|Oxygen consumption at peak exercise was measured at scheduled timepoints during treatment periods 1 and 3.|Period 1 and Period 3 ( within 8 weeks)|||ml/kg/min||95% Confidence Interval|Least Squares Mean
704710|NCT00094302|Secondary|Depression Symptoms, as Measured by Patient Health Questionnaire.|"Average post-baseline depression, taking into consideration baseline depression, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.
The Patient Health Questionnaire (PHQ) is a 10-item, self-administered instrument for screening, diagnosing, monitoring and measuring the severity of depression. Scores can range from 0-27, in which lower scores reflect better mental health status. The PH-Q was administered at the following study visits: baseline, month 12 and annually thereafter. Valid translations of this questionnaire were only available for subjects enrolled in the United States and Canada."|Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.|All Participants from the United States and Canada who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.||units on a scale||Standard Error|Least Squares Mean
704711|NCT00094302|Secondary|Quality of Life, as Measured by McMaster Overall Treatment Evaluation Questionnaire.|"Average post-baseline quality of life, taking into consideration baseline quality of life and treatment group.
The McMaster Overall Treatment Evaluation questionnaire is a self-administered 3-item instrument that measures a patient's perception of change in their health-related quality of life since the start of therapy. The questionnaire consists of a single question - Since treatment started, has there been any change in your activity limitation, symptoms and/or feelings related to your heart condition? Scores can range from -7 to +7, and higher scores reflect better health status. The questionnaire was administered at the following study visits: month 4 and month 12. Valid translations of this questionnaire were only available for subjects enrolled in the United States, Canada and Argentina."|Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.|All Participants from United States, Canada and Argentina who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.||units on a scale||Standard Error|Least Squares Mean
704712|NCT00094302|Secondary|Quality of Life, as Measured by the EuroQOL Visual Analog Scale.|"Average post-baseline quality of life, taking into consideration baseline quality of life, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.
The EuroQOL visual analog scale (EQ5D) is a single-item, self-administered instrument that quantifies current health status. Scores can range from 0-100, in which higher scores reflect better health status. The EQ5D was administered at the following study visits: baseline, month 4, month 12 and annually thereafter."|Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.||units on a scale||Standard Error|Least Squares Mean
704713|NCT00094302|Secondary|Quality of Life, as Measured by the Kansas City Cardiomyopathy Questionnaire.|"Average post-baseline quality of life, taking into consideration baseline quality of life, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.
The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. The KCCQ was administered at the following study visits: baseline, month 4, month 12 and annually thereafter."|Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.||units on a scale||Standard Error|Least Squares Mean
704714|NCT00094302|Secondary|Composite Outcome of Sudden Death, Aborted Cardiac Arrest, or Hospitalization for the Management of Ventricular Tachycardia, Whichever Occurred First||Randomization through each subject’s last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.||Events per 100 person-years|||Number
704715|NCT00094302|Secondary|Deterioration of Renal Function|First incidence of a deterioration of renal function. The TOPCAT protocol defines deterioration of renal function as occurring if a subject has a serum creatinine value which is at least double the baseline value for that subject, and is also above the upper limit of normal (assumed to be 1.0 mg/dL for females and 1.2 mg/dL for males.)|Randomization through each subject’s last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.||Events per 100 person-years|||Number
704716|NCT00094302|Secondary|Stroke|First incidence of stroke|Randomization through each subject’s last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.||Events per 100 person-years|||Number
704717|NCT00094302|Secondary|Myocardial Infarction|First incidence of myocardial infarction|Randomization through each subject’s last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.||Events per 100 person-years|||Number
704718|NCT00094302|Secondary|Development of Atrial Fibrillation, Among Subjects Without a History of Atrial Fibrillation at Baseline.|First incidence of atrial fibrillation among subjects without a history of atrial fibrillation at baseline|Randomization through each subject’s last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized and did not have a history of atrial fibrillation at baseline were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.||Events per 100 person-years|||Number
704719|NCT00094302|Secondary|New Onset Diabetes Mellitus, Among Subjects Without a History of Diabetes Mellitus at Baseline.|First incidence of new onset diabetes mellitus among subjects without a history of diabetes mellitus at baseline.|Randomization through each subject’s last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized and did not have a history of diabetes mellitus at baseline were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.||Events per 100 person-years|||Number
704720|NCT00094302|Secondary|Composite Outcome of Sudden Death or Aborted Cardiac Arrest, Whichever Occurred First||Randomization through each subject’s last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.||Events per 100 person-years|||Number
704721|NCT00094302|Secondary|Total Hospitalizations (Including Repeat Hospitalizations) for the Management of Heart Failure||Randomization through each subject’s last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.||Events per 100 person-years|||Number
704722|NCT00094302|Secondary|Cardiovascular-related Hospitalization|Hospitalization for MI, stroke or the management of heart failure, whichever occurred first|Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.||Events per 100 person-years|||Number
704723|NCT00094302|Secondary|Composite Outcome of Cardiovascular Mortality or Cardiovascular-related Hospitalization (i.e., Hospitalization for Myocardial Infarction(MI), Stroke, or the Management of Heart Failure), Whichever Occurred First||Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.||Events per 100 person-years|||Number
704724|NCT00094302|Secondary|All-cause Mortality||Randomization through each subject’s last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.||Events per 100 person-years|||Number
704725|NCT00094302|Secondary|Hospitalization for the Management of Heart Failure|First incidence of a hospitalization for the management of heart failure|Randomization through each subject’s last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.||Events per 100 person-years|||Number
704726|NCT00094302|Secondary|Aborted Cardiac Arrest|First incidence of aborted cardiac arrest|Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.||Events per 100 person-years|||Number
704727|NCT00094302|Secondary|Cardiovascular Mortality||Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.||Events per 100 person-years|||Number
704728|NCT00094302|Primary|Composite Outcome of Cardiovascular Mortality, Aborted Cardiac Arrest, or Hospitalization for the Management of Heart Failure, Whichever Occurred First||Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.||Events per 100 person-years|||Number
704729|NCT00094328|Secondary|Change in Predicted Adult Height (PAH)|Radiographs will be used to assess the bone age, the PAH is calculated from the bone age using the Bayley and Pinneau Method. The change in PAH will be calculated by subtracting the PAH at baseline from the PAH at 12 months.|Assessed after 12 months treatment|Calculated on All treated analysis set, however, if bone age is less than 6 years or bone age is less than 7 years and bone age>=(chronological age-1) then PAH cannot be calculated using the Bayley and Pinneau method.||cm||Standard Deviation|Mean
704730|NCT00094328|Secondary|Normalization of Growth Rate|The number of patients whose height lies between the 5th and 95th percentiles (using the percentile tables on the WHO database) for chronological age at the 12 month assessment.|Assessed after 12 months treatment|||Participants|||Number
704731|NCT00094328|Secondary|Change in Bone Maturation Rate|Radiographs were used to assess the bone age at ≥6 months pre-study, baseline, 6 months and 12 months. The rate of change in bone age at baseline was calculated from a radiograph taken at least 6 months prior to study enrolment. The change in bone maturation was calculated from this rate and that calculated at 12 months.|Assessed after 12 months treatment|Calculated on All treated analysis set for those patients who had a 6-month pre study radiograph.||cm/year||Standard Deviation|Mean
704732|NCT00094328|Primary|Change in Growth Rate (SD Units)|Change in growth rate after 12 months relative to the growth rate during the ≥6 month pre-study period, calculated after adjustment for the chronological age of the patient (expressed as a standard deviation [SD] score).|Assessed after 12 months treatment|||SD units||Standard Deviation|Mean
704733|NCT00094328|Primary|Change in Growth Rate (cm/Year)|Change in growth rate after 12 months relative to the growth rate during the ≥6 month pre-study period, based on raw height data (cm/year).|Assessed after 12 months treatment|||cm/year||Standard Deviation|Mean
704781|NCT00100841|Primary|Severe Adverse Event (SAE) Rate|The primary objective is to evaluate safety in all treated patients specifically the rate of serious adverse events which were defined as grade 5 events, grade 4 hemorrhage or thrombosis or bowel perforation|The duration of the study|66 patients treated with cetuximab||participants|||Number
704734|NCT00094458|Secondary|Average Corticosteroid Use|Average daily dose of systemic corticosteroid concomitant medications(prednisone or equivalent)|Weeks 2, 6, 10, 18 and 26|Population analyzed included all randomized participants taking corticosteroids for Crohn’s disease. n' signifies number of participants who were evaluable at specified time point, for each arm respectively.||milligram per day||Standard Deviation|Mean
704735|NCT00094458|Secondary|Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Weeks 2, 6, 10, 18 and 26 (Main Study)|Quality of life as measured by the Inflammatory Bowel Disease Questionnaire (IBDQ). The IBDQ is a 32- item questionnaire and the total IBDQ score can range from 32 (very poor) to 224 (perfect).|Baseline and Weeks 2, 6, 10, 18, 26|Population analyzed included all randomized participants enrolled in Main Study with last observation carried forward method to impute missing data. 'n' signifies number of participants who were evaluable at specified time point, for each arm respectively.||units on a scale||Standard Deviation|Mean
704736|NCT00094458|Secondary|Percentage of Participants With Clinical Response Over Time (Study Extension)|Clinical response, defined as a >=100-point decrease in CDAI from Baseline.|Weeks 34, 42, 50|Population analyzed included all randomized participants during the Study Extension.||percentage of participants|||Number
704737|NCT00094458|Secondary|Percentage of Participants With Clinical Response Over Time (Main Study)|Clinical response, defined as a >=100-point decrease in CDAI from Baseline.|Weeks 2, 6, 10, 18, 26|Population analyzed included all randomized participants during the Main Study.||percentage of participants|||Number
704738|NCT00094458|Secondary|Percentage of Participants With Clinical Remission (Study Extension)|Clinical remission is defined as a CDAI < 150, compared to baseline (Week 0)|Weeks 34, 42 and 50|Population analyzed included all randomized participants enrolled in the Study Extension.||percentage of participants|||Number
704739|NCT00094458|Secondary|Percentage of Participants With Clinical Remission (Main Study)|Clinical remission is defined as a CDAI < 150, compared to baseline (Week 0)|Weeks 2, 6, 10, 18 and 26|Population analyzed included all randomized participants enrolled in the main study.||percentage of participants|||Number
704740|NCT00094458|Secondary|Percentage of Participants With Corticosteroid-free Clinical Remission (Study Extension)|Corticosteroid-free clinical remission is defined as a Crohn's Disease Activity Index (CDAI) < 150 who have not received any dose of systemic corticosteroids (prednisone or equivalent) for >= 3 weeks and have not received budesonide at a dose > 6 milligram per day (mg/day) for >= 3 weeks. The total CDAI score ranges from 0 - 600. The lower the CDAI score, the better (i.e., 0 is better and 600 is worse).|Week 50|Population analyzed included all randomized participants enrolled in Study Extension.||percentage of participants|||Number
704741|NCT00094458|Secondary|Percentage of Participants With Mucosal Healing|Complete absence of mucosal ulcerations in the colon and terminal ileum as assessed by video endoscopy.|Week 26|Analysis population for mucosal healing was per protocol. All subjects with lesions at Baseline (Week 0) and an Endoscopy at Week 26 were included in the analysis. Here, ‘N’ [number of participants analyzed] signifies those participants who were evaluable for this measure.||percentage of participants|||Number
704742|NCT00094458|Primary|Percentage of Participants With Corticosteriod-free Clinical Remission|Corticosteroid-free clinical remission is defined as a Crohn's Disease Activity Index (CDAI) less than (<) 150 in participants who have not received any dose of systemic corticosteroids (prednisone or equivalent) for greater than or equal to (>=) 3 weeks and have not received budesonide at a dose > 6 milligram per day (mg/day) for >= 3 weeks. The total CDAI score ranges from 0 - 600. The lower the CDAI score, the better (i.e., 0 is better and 600 is worse).|Week 26|Intention to treat (ITT) population includes all randomized participants in the analysis, according to the treatment group to which they were randomized, regardless of the treatment they actually received.||percentage of participants|||Number
704743|NCT00100178|Primary|Mean Stimulated C-peptide Area Under the Curve|The primary outcome is the area under the stimulated C-peptide curve (AUC) based on data collected at time 0 to 2 hours of a 4-hour mixed meal glucose tolerance test (MMTT) conducted at the primary endpoint visit. The timed measurements are done at: 0, 15, 30 60, 90, and 120 minutes.|2 years|Participants who completed a 4-hour mixed meal glucose tolerance test at the two-year visit were included in the analysis||pmol/ml||95% Confidence Interval|Geometric Mean
704747|NCT00100659|Secondary|Adverse Events|Influenza-like, headache, and gastrointestinal symptoms|Every study visit||||||
704748|NCT00100659|Secondary|Laboratory Assessments|complete blood count,blood urea nitrogen,creatinine, glucose,calcium, phosphorus, aspartate aminotransferase,alanine aminotransferase, alkaline phosphatase, bilirubin|Every study visit||||||
704749|NCT00100659|Secondary|Vital Signs Events.|Heart rate, blood pressure, respirations|Every study visit||||||
704750|NCT00100659|Primary|Sustained Viral Response (SVR)|SVR is defined as nondetectable hepatitis C virus ribonucleic acid (HCV RNA) in plasma|at least 24 weeks after stopping treatment.|||participants|||Number
704751|NCT00100698|Secondary|Change in Systolic Blood Pressure|Change in systolic blood pressure|18 months|||mm Hg||Standard Error|Mean
704752|NCT00100698|Secondary|Change in 2-hour Glucose|Change in 2-hour glucose|18 months|||mg/dL||Standard Error|Mean
704753|NCT00100698|Secondary|Change in Extremity Fat|Change in extremity fat|18 months|||kilograms||Standard Error|Mean
704754|NCT00100698|Secondary|Change in Body Mass Index|Change in body mass index|18 months|||kilogram/meters squared||Standard Error|Mean
704755|NCT00100698|Secondary|Change in Carotid Intima Media Thickness (IMT)|change in carotid intima media thickness (IMT)|18 months|||millimeter||Standard Error|Mean
704758|NCT00100698|Secondary|Change in Quality of Life Score From the Medical Outcomes Study-HIV Survey From Baseline to 18 Months|Change in quality of life score was measured by the Medical Outcomes Study-HIV (MOS-HIV)survey. The MOS-HIV asks patients to report on health-related quality of life and physical function from the past 4 days. The scoring range is 0-100, and a higher score indicates better quality of life.|18 months|||units on a scale||Standard Error|Mean
704759|NCT00100698|Secondary|Change in Lean Body Mass|change in lean body mass|18 months|||kilograms||Standard Error|Mean
704760|NCT00100698|Secondary|Change in Logarithm HIV Viral Load|Change in logarithm base 10 HIV viral load|18 months|||log base 10 copies of RNA/milliliter||Standard Error|Mean
704761|NCT00100698|Secondary|Change in CD4 Cells|Change in CD4 cells|18 months|||cells/microliter||Standard Error|Mean
704762|NCT00100698|Secondary|Change in Subcutaneous Adipose Tissue|Change in subcutaneous adipose tissue|18 months|||centimeters squared||Standard Error|Mean
704763|NCT00100698|Secondary|Change in Triglycerides|Change in triglycerides|18 months|||mg/dL||Inter-Quartile Range|Median
704764|NCT00100698|Secondary|Change in Trunk to Extremity Ratio|change in trunk to extremity ratio|18 months|||kilogram per kilogram||Standard Error|Mean
704765|NCT00100698|Secondary|Change in Fasting Glucose|change in fasting glucose|18 months|||mg/dL||Standard Error|Mean
704766|NCT00100698|Secondary|Change in Trunk Fat||18 months|||kilograms||Standard Error|Mean
704767|NCT00100698|Secondary|Change in Insulin-like Growth Factor-I From Baseline to 18 Months|Change in insulin-like growth factor-1|18 months|||nanograms/milliliter||Standard Error|Mean
704768|NCT00100698|Primary|Change in Visceral Adipose Tissue Area From Baseline to 18 Months|change in visceral adipose tissue area as measured by single-slice abdominal computed tomographic scan|18 months|||centimeters squared||Standard Error|Mean
704769|NCT00100789|Secondary|Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|Patients were assessed for adverse events after the first cycle of treatment and then every three months while on treatment.|Eligible patients who received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.||Participants with a given type of AE|||Number
704770|NCT00100789|Secondary|Response|Complete Response (CR) is complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Normalization of markers and other normal lab values. Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration.|9 weeks - 3 years|All eligible patients with measurable disease who started treatment were included in response measures.||participants|||Number
704771|NCT00100789|Primary|Overall Survival|Measured from time of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|0 - 3 years|All eligible patients who started treatment were included in this measure.||months||95% Confidence Interval|Median
704772|NCT00100789|Secondary|Progression-free Survival|Measured from date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.|0 - 3 years|All eligible patients who started treatment were included in this measure.||months||95% Confidence Interval|Median
704773|NCT00100802|Primary|Occurrence of Death Attributable to Complications of Protocol Therapy|Number of deaths due to complications of protocol therapy.|While receiving protocol therapy (up to 301 days excluding delays) or within 30 days of Termination of Protocol Therapy|106 eligible patients out of 118 patients enrolled is the population basis for this outcome measure.||patients|||Number
704774|NCT00100802|Primary|One Year Overall Survival|Estimated one year survival using the Kaplan-Meier methodology.|One year|Population is based on 106 eligible patients out of 118 patients enrolled.||Estimated probability||95% Confidence Interval|Number
704775|NCT00100815|Secondary|Overall Survival||every 2-4 months for 1 year and then every 6 months for 5 years|All treated and eligible patients||months||90% Confidence Interval|Median
704776|NCT00100815|Secondary|Clinical Response|Response was evaluated using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000]. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter; Overall Response (OR) = CR + PR.|Pre-treatment and every 6 weeks from treatment.|All treated and eligible patients||percentage of participants||95% Confidence Interval|Number
704777|NCT00100815|Secondary|Percentage of Participants With Improved Quality of Life|Quality of Life was assessed using EORTC QLQ-PAN26. All measures range in score from 1 to 4 as lower scores indicate better outcomes. The improved Quality of Life is defined as a greater than 5% decrease in 2 consecutive scores compared with the baseline score.|assessed at baseline then weekly for 3 weeks|All treated and eligible patients||percentage of participants||95% Confidence Interval|Number
704778|NCT00100815|Secondary|Percentage of Participants With Grades 3-5 Treatment Related Toxicities|Grade 3, 4 or 5 toxicity rate|Subjects were evaluated for adverse events at each study visit for the duration of their participation in the study, up to 5 years|All treated and eligible patients||percentage of participants||95% Confidence Interval|Number
704779|NCT00100815|Primary|Progression-free Survival|Progressive Disease is defined using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000], as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions, or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|every 2-4 months for 1 year and then every 6 months for 5 years|All treated and eligible patients||months||95% Confidence Interval|Median
704780|NCT00100841|Primary|Progression Free Survival Rate||From randomization to the first documented disease progression|||months||95% Confidence Interval|Median
704783|NCT00100932|Secondary|Progression Free Survival|Defined as the time from the start of study medication until progressive disease or death from any cause during the study period.|From start of study medication until progressive disease or death|Intent to Treat/Safety Population||Days||Full Range|Median
704784|NCT00100932|Secondary|Duration of Response|Measured from the time that measurement criteria were met for complete response (CR) and partial response (PR) until the first date that recurrence or progressive disease was objectively documented.|From time of CR or PR until recurrence or progressive disease|Intent to Treat/Safety Population||Days||Full Range|Median
704785|NCT00100932|Primary|Overall Objective Response Rate (ORR)|Based on Response Evaluation Criteria in Solid Tumors (RECIST), consisting of complete response (CR) plus partial response (PR). Defined as the best response from the start of treatment until disease progression or recurrence. Lesions measured by computed tomography (CT) scan and magnetic resonance imaging (MRI). Objective response rate: complete response (CR-disappearance of all lesions)+ partial response (PR-30% decrease in lesion diameter), Progressive Disease (PD-20% increase in lesion diameter), stable disease (SD-neither shrinkage nor increase of lesions).|From start of treatment until disease progression or recurrence|Intent to Treat/Safety Population||percentage of participants|||Number
704786|NCT00101036|Secondary|Disease Control Rate (i.e., the Mathematical Sum of Percentages of Complete Response, Partial Response and Stable Disease)||Up to 5 years||||||
704787|NCT00101036|Secondary|Progress-free Survival|Estimated using the Kaplan-Meier method. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions.|Up to 5 years|||Months||95% Confidence Interval|Median
704788|NCT00101036|Secondary|Overall Survival|Estimated by the Kaplan-Meier method.|Up to 5 years|||Months||95% Confidence Interval|Median
704789|NCT00101036|Primary|Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT, MRI or X-Ray: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Up to 5 years|||percentage of responding patients|||Number
704790|NCT00101101|Secondary|Median Event Free Survival (EFS)|Vaccine Response - EFS among participants who received vaccination. Event free survival (EFS) was calculated from date of enrollment until progression or death from any cause. Progressive disease (PD): At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|18 months|Participants who received at least one vaccine injection.||months||95% Confidence Interval|Median
704791|NCT00101101|Secondary|Occurrence of Related Serious Adverse Events (SAEs)|Patients were monitored for toxicity every 4 weeks in clinic throughout the 4-month vaccination phase. This included clinical and laboratory evaluation (CBC, blood urea nitrogen (BUN), creatinine, electrolytes, liver function test (LFT), and serum LDH). Toxicity was defined according to the NCI Common Terminology Criteria for Adverse Events (CTCAE-3) Version 3.0 (www.ctep.cancer.gov). Grade 3 or higher SAEs attributed to vaccination: Toxicity was assessed in the 23 patients who received at least one vaccine injection.|4 months per participant|Participants who received at least one vaccine injection.||participants|||Number
704792|NCT00101101|Primary|Rate of Immunological Response to Vaccination|"Immunological response to vaccination, as measured by in vitro testing of peripheral blood mononuclear cells (PBMCs) for interferon gamma secretion, delayed type hypersensitivity reaction (DTH) in response to irradiated autologous tumor cells, and lymphocyte accumulation at DTH and vaccine injection sites.
DTH Skin Testing was performed within 2 weeks prior to first vaccine, and again after fourth vaccine was administered. Aliquots containing 10^6 irradiated autologous tumor cells were re-suspended in 0.2 mL of Plasma-Lyte A and injected intradermally in the forearm and marked. 48 hours later, injection site was inspected for induration and erythema.
3mm punch biopsy of DTH injection site and vaccine site was obtained 48 hours after administration of irradiated tumor cells before and after the vaccine series. Vaccine site biopsy was obtained 2-5 days after the second vaccine had been given. Granulocytic and lymphocytic accumulation at these sites was graded by a pathologist."|4 months per participant|Participants who received at least one vaccine injection.||participants|||Number
704793|NCT00101166|Secondary|Overall Survival (OS) in Months|Average overall survival time in months.|Average of 14 months|All 28 participants who were vaccinated on this study.||months||95% Confidence Interval|Mean
704794|NCT00101166|Secondary|Time to Progression (TTP) in Months|Response and progression were evaluated using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Progressive disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Average of 14 months|All 28 participants who were vaccinated on this study.||months||95% Confidence Interval|Mean
704795|NCT00101166|Secondary|Number of Participants With Stable Disease|Patients with stable disease by RECIST criteria after 3 vaccine injections. Response and progression were evaluated using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Average of 14 months|All 28 participants who were vaccinated on this study.||participants|||Number
704796|NCT00101166|Primary|Number of Participants With Partial Response|Response and progression were evaluated using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|Average of 14 months|All 28 participants who were vaccinated on this study.||participants|||Number
704797|NCT00101166|Secondary|Number of Participants With Serious Adverse Events (SAEs) Related to Study Treatment|Frequency of Study Related Toxicity. To evaluate the toxicity of the autologous tumor cell / GM.CD40L bystander cell vaccine. Toxicity was scored using the NCI Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE-3).|Average of 14 months|All 28 participants who were vaccinated on this study.||participants|||Number
704798|NCT00101192|Secondary|Progression-free Survival and Overall Survival at 6 Months After Completion of Treatment||up to 5 years from study entry||||||
704799|NCT00101192|Primary|Tumor Response|"Per GOG Response Evaluation Criteria In Solid Tumors(RECIST) Criteria:
Complete Response(CR): disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart.
Partial Response(PR): at least a 30% decrease in the sum of longest dimensions(LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of nontarget lesions and no new lesions.
Increasing Disease: at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.
Stable Disease: any condition not meeting the above criteria.
Indeterminate for response: as having no repeat tumor assessments following initiation of study therapy for reasons unrelated to symptoms or signs of disease."|up to 6 months from study entry|Eligible and evaluable participants||participants|||Number
704800|NCT00101283|Secondary|Progression-Free Survival|Time from randomization to the earlier of disease progression or death. Patients alive and progression-free at last follow-up were censored.|Assessed every 3 months for 2 years, then every 6 months for 1 year|The population consisted of all eligible, treated patients. 3 patients randomized to pemetrexed/gemcitabine who withdrew prior to treatment are excluded.||Months||95% Confidence Interval|Median
704801|NCT00101283|Secondary|Overall Survival|Time from randomization to death. Patients alive at last follow-up were censored.|Assessed every 3 months for 2 years, then every 6 months for 1 year|The population consisted of all eligible, treated patients. 3 patients randomized to pemetrexed/gemcitabine who withdrew prior to treatment are excluded.||Months||95% Confidence Interval|Median
704802|NCT00101283|Primary|Best Overall Response by RECIST Criteria (Version 1.0)|Number of eligible, treated participants in each response category by RECIST criteria. Response categories represent best response for each patient prior to progression.|Assessed every 2 cycles (6 weeks) while on treatment, then every 3 months for 2 years, then every 6 months for 1 year until disease progression|The population consisted of all eligible, treated patients. 3 patients randomized to pemetrexed/gemcitabine who withdrew prior to treatment are excluded.||eligible, treated participants|||Number
704803|NCT00101361|Primary|A Healed Pressure Ulcer|Patients remained in treatment until full healing of the target pressure ulcer (defined as re-epithelialization to a cicatrix with a dry surface and zero open area for a minimum of 96 hours) or 24 weeks, whichever occured first.|healing was measured from randomization to full healing or 24 weeks, whichever occured first.|||participants|||Number
704804|NCT00101400|Secondary|Number of Subjects With Stable Disease up to Cycle 4|Number of subjects who had not responded to treatment but had stable disease up to cycle 4.|Until 30 days after termination of active therapy|Intent to treat population consisting of subjects who received at least 1 dose of sorafenib.||participants|||Number
704805|NCT00101400|Secondary|Survival Time|After the end of treatment visit (30 days after the last dose), the subjects were monitored every 3 months for survival (visits/phone calls).|Start of treatment to death|Intent to treat population consisting of subjects who received at least 1 dose of sorafenib.||days||95% Confidence Interval|Median
704806|NCT00101400|Secondary|Overall Response Duration|Overall response duration was defined only for subjects achieving confirmed objective response (PR or CR). It was measured from start of treatment to the date when progressive disease was first objectively documented.|Time from PR or CR to progression|1 subject out of 54 achieved PR.||days|||Number
704807|NCT00101400|Secondary|Time to Objective Response|Defined only for subjects achieving objective tumor response from start of treatment to the date when confirmed PR or CR was first documented according to the Modified WHO Tumor Response Criteria.|Until objective response occurs|1 subject out of 54 achieved PR.||days|||Number
704808|NCT00101400|Secondary|Time to Progression|Time from start of treatment until progression was first documented.|Until progression occurs|Of the intent to treat population, 4 subjects died before assessment of progression; for 1 subject the progression date not available; and 1 subject was lost to follow-up.||days||95% Confidence Interval|Median
704809|NCT00101400|Primary|Number of Subjects With Response (Complete or Partial)|Number of subjects with metastatic breast cancer treated with single agent BAY43-9006 who had best overall response assessed as complete response (CR) or partial response (PR) as per Modified World Health Organization (WHO) Tumor Response Criteria.|Until 30 days after termination of active therapy|Intent to treat population consisted of subjects who received at least 1 dose of sorafenib.||participants|||Number
704810|NCT00101413|Secondary|Change From Baseline of Health-Related Quality of Life (HRQOL) Score Assessed at Cycle 2, Cycle 4, and End of Treatment (EOT)|HRQoL was assessed with the FACT-L questionnaire, a validated instrument for determining lung cancer HRQoL. The 36-item questionnaire includes 4 domains: Physical, functional, emotional, and social/family well-being, and a lung cancer-specific subscale. The FACT-L total score ranges from 1 to 136. Lower scores (negative change from baseline) demonstrate impaired HRQoL.|From first patient first treatment until date of last efficacy data collection (study period up to 62 weeks). HRQoL assessed at baseline (BL), end of treatment Cycles 2 and 4, and at end of treatment|The analysis population for the intent to treat (ITT) and safety analyses consisted of 52 subjects who received at least 1 treatment and had their disease re-evaluated. Of the 52 treated subjects, 50 subjects completed the FACT-L at baseline (screening) and post-treatment.||scores on a scale||Standard Deviation|Mean
704811|NCT00101413|Secondary|Percentage of Subjects With Stable Disease (SD)|Percentage of subjects with stable disease was calculated from date of first treatment until date of documented progressive disease (PD) or last observation if subject did not progress. Stable disease (SD) defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Descriptive summary of subjects with SD.|First patient first treatment until date for last data collection for efficacy for a study period up to 62 weeks. Tumor assessed per RECIST at baseline (BL), every 8 weeks during treatment and at end of treatment.|The analysis population for the intent to treat (ITT) and safety analyses consisted of 52 subjects who received at least 1 treatment and had their disease re-evaluated. 51 subjects were considered evaluable since 1 of the 52 subjects had lung metastases from pancreatic cancer.||Percentage of participants|||Number
704865|NCT00101686|Secondary|Survival Time: FOLFIRI, mIFL and CapeIRI|Survival time defined as time from date of randomization to date of death. In the absence of confirmation of death, survival time was censored to last date the subject known to be alive.|assessed at least every week during treatment and at least every 3 months during follow-up|ITT Population.||months||95% Confidence Interval|Median
704812|NCT00101413|Secondary|Overall Survival|"Overall survival was calculated from the date of the first treatment until death of the subject.
Evaluation by Kaplan-Meier methodology, descriptive analysis."|First patient first treatment until date for last data collection for efficacy for a study period up to 62 weeks.|The analysis population for the intent to treat (ITT) and safety analyses consisted of 52 subjects who received at least 1 treatment and had their disease re-evaluated. 51 subjects were considered evaluable since 1 of the 52 subjects had lung metastases from pancreatic cancer.||days||95% Confidence Interval|Median
704813|NCT00101413|Secondary|Duration of Stable Disease|Duration of stable disease was calculated as date of first treatment until date of documented progressive disease (PD) or last observation if subject did not progress. Stable disease (SD) defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Kaplan-Meier methodology, descriptive analysis.|First patient first treatment until date for last data collection for efficacy for a study period up to 62 weeks. Tumor assessed per RECIST at baseline (BL), every 8 weeks during treatment and at end of treatment.|The analysis population for the intent to treat (ITT) and safety analyses consisted of 52 subjects who received at least 1 treatment and had their disease re-evaluated. 1 of the 52 subjects had lung metastases from pancreatic cancer and was excluded from analysis. 48 subjects had tumor evaluations post-baseline and were evaluable.||days||95% Confidence Interval|Median
704814|NCT00101413|Primary|Anti-cancer Activity (eg, Percentage of Patients With Confirmed Complete Responses (CR) and Partial Responses (PR) Per RECIST (Response Evaluation Criteria in Solid Tumors) Criteria in Patients With Stage IV Non-small Cell Lung Carcinoma (NSCLC)|CR-disappearance of clinical/radiological tumor evidence (target/nontarget). PR- >=30% decrease in sum longest diameter (LD) of target lesions from BL sum LD. Stable disease (SD)-no shrinkage for PR nor increase for PD. Progressive disease (PD) measurement proven- >=20% increase in sum LD of lesions from smallest sum LD since start or new lesions. Progression by clinical judgement- >clinically meaningful cancer-related deterioration as judged by the investigator.|First patient first treatment until date for last data collection for efficacy for a study period up to 62 weeks. Tumor assessed per RECIST at baseline (BL), every 8 weeks during treatment and at end of treatment.|The analysis population for the intent to treat (ITT) and safety analyses consisted of 52 subjects who received at least 1 treatment and had their disease re-evaluated. 51 subjects were considered evaluable since 1 of the 52 subjects had lung metastases from pancreatic cancer.||percentage of participants|||Number
704815|NCT00101439|Secondary|Total Cholesterol Concentration of Chylomicron-remnant (Sf 60-400) Subfractions After a Cholesterol-Rich Test Meal|On each of 2 days prior to the last day of each treatment period, participants consumed 2 large eggs in the evening. On the morning of the final day of each treatment period, fasting participants were given a site-prepared, cholesterol-enriched milkshake that provided 1114 calories of total energy (~44% of calories from fat, ~40% of calories from carbohydrate and ~17% of calories from protein) and 504 mg of cholesterol. The milkshake was consumed over a 15-minute period. Plasma samples were collected immediately prior to consumption of the test meal (baseline) and at 2, 3, 4, and 6 hours afterwards for isolation and analysis of lipoprotein subfractions. The geometric mean concentration level was calculated using data obtained at all timepoints.|Immediately prior to consumption of the test meal (baseline) and at 2, 3, 4, and 6 hours after test meal on Day 28 of each treatment period.|Participants who received at least one dose of study drug and did not have any protocol violations.||mg/dL||Full Range|Geometric Mean
704816|NCT00101439|Primary|Total Cholesterol Concentration of Chylomicron (Sf≥400) Fractions After a Cholesterol-Rich Test Meal|On each of 2 days prior to the last day of each treatment period, participants consumed 2 large eggs in the evening. On the morning of the final day of each treatment period, fasting participants were given a site-prepared, cholesterol-enriched milkshake that provided 1114 calories of total energy (~44% of calories from fat, ~40% of calories from carbohydrate and ~17% of calories from protein) and 504 mg of cholesterol. The milkshake was consumed over a 15-minute period. Plasma samples were collected immediately prior to consumption of the test meal (baseline) and at 2, 3, 4, and 6 hours afterwards for isolation and analysis of lipoprotein fractions. The geometric mean concentration level was calculated using data obtained at all timepoints.|Immediately prior to consumption of the test meal (baseline) and at 2, 3, 4, and 6 hours after test meal on Day 28 of each treatment period.|Participants who received at least one dose of study drug and did not have any protocol violations.||mg/dL||Full Range|Geometric Mean
704817|NCT00101452|Primary|Hamilton Rating Scale for Depression (HAM-D)|The change in total HAM-D score between baseline and endpoint was the primary outcomes measure. This measure is a clinician rated inventory of depressive symptoms. All items are scored on a scale of zero to four and the sum of the scores provides the total score for the measure. Scores can range from 0- 68. On this scale, higher scores indicate poorer outcomes.|baseline and 24 weeks|Based on having at least one post-baseline visit.||units on a scale||Standard Deviation|Mean
704818|NCT00101582|Secondary|Number of Participants With Unplanned Breaks in Radiotherapy|Participants with a duration of 5 days or more without an administration of radiotherapy or who discontinue radiotherapy prior to completion of planned radiotherapy were considered to have an unplanned break in radiotherapy.|During the 7 weeks of radiotherapy|Full analysis set||participants|||Number
704819|NCT00101582|Secondary|Number of Participants With Unplanned Breaks in Cisplatin Chemotherapy Treatment|Cisplatin was administered on Days 1, 22, and 43. An unplanned break in cisplatin refers to a delay of ≥ 5 days from the scheduled Day 22 or Day 43 cisplatin administration or a discontinuation of cisplatin for any reason.|During the 7 weeks of chemotherapy treatment|Full analysis set||participants|||Number
704820|NCT00101582|Secondary|Total Dose of Opioid Analgesics Used for Mucositis Within 15 Weeks|"The total dose of opioid analgesics (mg of intravenous [IV] morphine equivalents) used by all participants.
Participants with at least one reported administration of opioid analgesic (parenteral, peroral or transdermal) were considered to have received opioid analgesics. The total dose of opioid analgesics is the sum of all opioid analgesic administrations that have been converted to morphine equivalents."|Up to 15 weeks|Full analysis set||mg of IV morphine equivalents||Standard Deviation|Mean
704866|NCT00101686|Secondary|Overall Response: FOLFIRI, mIFL and CapeIRI|A subject will be considered achieving an overall response if the subject has a sustained Complete Response (CR) or Partial Response (PR) for at least 4 weeks, confirmed by tumor assessments. (CR: Disappearance of all target lesions. PR: greater than or equal to 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the Pre-treatment sum LD. )|every 6 weeks during chemotherapy until disease progression|ITT Population.||participants|||Number
704821|NCT00101582|Secondary|Patient-Reported Mouth and Throat Soreness Score|"The average patient-reported mouth and throat soreness (MTS) score as reported on question 3 of the Oral Mucositis Weekly Questionnaire for Head and Neck Cancer [OMWQ-HN]): How much mouth and throat soreness did you experience in the past 24 hours? Participants answered on a scale from 0 (no soreness) to 4 (extreme soreness).
For each participant, an average patient-reported mouth and throat soreness score was calculated by dividing the sum of the MTS scores at each assessment by the total number of assessments."|Assessed twice a week for up to 15 weeks.|"The Patient Reported Outcome-evaluable analysis set included all randomized patients with a valid Baseline assessment for MTS question 3 of the OMWQ-HN and either:
At least 1 completed assessment each week for MTS up to withdrawal/Week 8, whichever came first, or
70% or greater overall compliance for MTS until withdrawal/Week 8."||units on a scale||Standard Deviation|Mean
704822|NCT00101582|Secondary|Number of Participants With Xerostomia at Month 4 (Grade 2 or Higher)|The number of participants with grade 2 or higher xerostomia (dryness of the oral mucosa) at the Month 4 visit, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 Dry Mouth/Xerostomia scale.|Month 4|Full Analysis Set||participants|||Number
704823|NCT00101582|Secondary|Time to Onset of Severe (WHO Grade 3 or 4) Oral Mucositis|"Time to onset of severe (WHO Grade 3 or 4) oral mucositis (OM) was analyzed using the Kaplan-Meier procedure.
Participants without an assessed event by the end of the acute OM evaluation phase were censored at the date of last assessment for severe OM."|Up to 15 weeks|Full analysis set||days||Inter-Quartile Range|Median
704824|NCT00101582|Secondary|Duration of Severe (WHO Grade 3 or 4) Oral Mucositis|The duration of severe oral mucositis (OM) was calculated as the number of days from the onset of severe OM (first time a WHO grade 3 or 4 was observed) to the day when severe OM was resolved (first time WHO grade 2 or less was observed after last WHO grade 3 or 4). Durations of 0 days were assigned to those participants who did not experience any WHO grade 3 or 4 during the study.|Up to 15 weeks|Full analysis set||days||Inter-Quartile Range|Median
704825|NCT00101582|Primary|Number of Participants With Severe (Grade 3 or 4) Oral Mucositis|Participants underwent evaluations of oral mucosal (OM) surfaces (mucositis assessments) 2 times weekly throughout radio/chemotherapy, and 2 times weekly thereafter until severe OM returned to grade ≤ 2 or until Week 15. During each evaluation, the following anatomical areas were assessed: upper lip; lower lip; right cheek; left cheek; right ventral & lateral tongue; left ventral & lateral tongue; floor of the mouth; hard palate; soft palate. A trained evaluator documented the findings using the World Health Organization (WHO) oral toxicity scale according to the following: Grade 0 = None; Grade 1 = Soreness, erythema; Grade 2 = Erythema, ulcers, ability to eat solids; Grade 3 = Ulcers, requires liquid diet; Grade 4 = Alimentation not possible.|Up to Week 15|The Full Analysis Set included all randomized participants.||participants|||Number
704826|NCT00101647|Secondary|Population PK of Dasatinib|Population pharmacokinetic analysis was not done because it is not meaningful for this single study|Day 8 immediately prior to the first daily dose and between 30 minutes to 3 hours following this dose.|||Population PK analysis|||Number
704827|NCT00101647|Secondary|Pharmacokinetics (PK) of Dasatinib and Its Metabolite BMS-582691 - Plasma Half-life (T-HALF)|The T-HALF was calculated as Ln2/Lz,where Lz was the absolute value of the slope of the terminal log-linear phase.|Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours.|29 participants had dense PK sampling on Day 1 and Day 8; parameters for 2 participants on Day 8 were excluded due to unreliable data. Participants with all concentration-time values < than the limit of quantitation were treated as missing for PK analysis. n= participants included in the statistical analyses of PK on Day 1 and Day 8, respectively.||hours||Standard Deviation|Mean
704828|NCT00101647|Secondary|Pharmacokinetics (PK) of Dasatinib and Its Metabolite BMS-582691 - Time to Maximum Observed Plasma Concentration (Tmax)|The Tmax was obtained from experimental observations. Using no weighting factor, the terminal log-linear phase of the concentration-time curve was identified by least-square linear regression of at least 3 data points that yielded a maximum G-criteria,which is also referred to as adjusted R-squared.|Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours.|A total of 29 participants had dense PK sampling on both Day 1 and Day 8; parameters for 2 participants on Day 8 were excluded due to unreliable concentration-time profiles. n=the number of participants on Day 1 and Day 8 who were included in the statistical analyses of PK parameters.||hours||Standard Deviation|Mean
704829|NCT00101647|Secondary|Pharmacokinetics (PK) of Dasatinib and Its Metabolite BMS-582691 - Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Time Point Within the Dosing Interval of 12 Hours (AUC[0-T])|The AUC(0-T) was calculated using the mixed log-linear trapezoidal algorithm in Kinetica™. In the calculation of AUC(0-T), predose concentrations that were less than the lower limit of quantitation (LLQ) were assigned a value of zero.|Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours.|29 participants had dense PK sampling on Day 1 and Day 8; parameters for 2 participants on Day 8 were excluded due to unreliable data. Participants with all concentration-time values < than the limit of quantitation were treated as missing for PK analysis. n= participants included in the statistical analyses of PK on Day 1 and Day 8, respectively.||ng∙h/mL||Standard Deviation|Mean
704830|NCT00101647|Secondary|Pharmacokinetics (PK) of Dasatinib and Its Metabolite BMS-582691 - Maximum Observed Plasma Concentration (Cmax)|The Cmax was obtained from experimental observations. Using no weighting factor, the terminal log-linear phase of the concentration-time curve was identified by least-square linear regression of at least 3 data points that yielded a maximum G-criteria,which is also referred to as adjusted R-squared.|Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours.|29 participants had dense PK sampling on Day 1 and Day 8; parameters for 2 participants on Day 8 were excluded due to unreliable data. Participants with all concentration-time values < than the limit of quantitation were treated as missing for PK analysis. n= participants included in the statistical analyses of PK on Day 1 and Day 8, respectively.||ng/mL||Standard Deviation|Mean
704831|NCT00101647|Secondary|Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, Hematologic Toxicities, and Toxicities Leading to Discontinuation|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition regardless of causal relationship with treatment. SAE=any untoward medical occurrence at any dose that: results in death; is life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability; is cancer; is congenital anomaly/birth defect; results in drug dependency/abuse; is an important medical event. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death)|Continuous from pretreatment through each 4-week cycle and at follow-up. (treatment continued until discontinuation due to toxicity, disease progression, or other protocol-specified criteria).|||Participants|||Number
704832|NCT00101647|Secondary|Minimal Clinically Significant Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G)|Number of subjects with minimally significant changes from baseline in the health-related quality of life questionnaire FACT-G. FACT-G=27 questions in 4 domains: physical, social/family, emotional, and functional well-being (PWB, SWB, EWB, FWB). Total score=0 to 108; higher score=better health-related quality of life. Total Score change of 7 or more=minimal clinical important change; PWB, EWB, and FWB score change of 3 or more, and SWB score change of 2 or more=minimal clinically important change.|Baseline, every 2 weeks for the first 3 cycles, following every 4-week cycle, and once at follow-up.(treatment continued until discontinuation due to toxicity, disease progression, or other protocol-specified criteria).|Number of participants with FACT-G assessments at baseline and at least one assessment during treatment||Participants|||Number
704833|NCT00101647|Secondary|MaHR and MCyR Among Participants With Baseline BCR-ABL Point Mutations|Major hematologic and cytogenetic responses (MaHR and MCyR) to dasatinib in subjects with mutations at baseline, including imatinib-resistant mutations (IRM) and specific BCR-ABL mutations (SBAM). BCR-ABL=the fused gene found in subjects with this type of CML. Criteria for MaHR are specified in Outcome Measure 2. MCyR=combined complete cytogenetic and partial cytogenetic response rate. Complete Cytogenetic Response= 0% Ph+ Cells in Metaphase in Bone Marrow, Partial Cytogenetic Response > 0% to 35% Ph+ Cells in Metaphase in Bone Marrow.|Baseline, at time of disease progression. (treatment continued until discontinuation due to toxicity, disease progression, or other protocol-specified criteria).|All subjects with baseline mutation data; n=the number of participants with the specified mutation. Baseline mutation data were reported for 162 of the 174 subjects (12/13 imatinib-intolerant and 150/161 imatinib-resistant). At baseline, 89 (59%) imatinib-resistant subjects and 1 imatinib-intolerant subject expressed imatinib resistant mutations.||Percentage of participants|||Number
704834|NCT00101647|Secondary|Number of Participants Who Achieved a Major Molecular Response (MMR) During Treatment Period|Number of participants who achieved an MMR at any time during the treatment period. MMR was calculated by measuring BCR-ABL transcripts in blood during treatment using quantitative reverse transcription-polymerase chain reaction (RT-PCR). BCR-ABL=the fused gene found in subjects with this type of Chronic Myeloid Leukemia (CML).|Baseline, every 12 weeks throughout study (treatment continued until discontinuation due to toxicity, disease progression, or other protocol-specified criteria).|Number of Participants Analyzed=all treated subjects who were assessed for major molecular response; n=participants with or without CCyR in cohort.||participants|||Number
704835|NCT00101647|Secondary|Best Confirmed Hematologic Response|Number of participants with confirmed complete hematologic response (CHR) or No Evidence of Leukemia (NEL), minor hematologic response (MiHR), or no hematologic response. Confirmed hematologic response=response that is confirmed after at least 4 weeks with no concomitant use of anagrelide or hydroxyurea use during this interval. Criteria for CHR and NEL are specified in Outcome Measure 2; criteria for MiHR are specified in Outcome Measure 4.|Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during treatment; at end of treatment|All treated subjects||Participants|||Number
704836|NCT00101647|Secondary|Best Cytogenetic Response|Number of participants with complete, partial, minor, minimal, or no cytogenetic response. Determination of cytogenetic response based on the prevalence (percentage) of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase in a bone marrow sample (aspirates/biopsies).|Baseline (within 4 weeks of therapy start); Every month for Cycles 1-3; Every 12 weeks for Cycles 4+; end of treatment|All treated subjects||Participants|||Number
704837|NCT00101647|Secondary|Time to OHR|Median time (in months) from first dosing date to date of OHR. OHR=best confirmed response of MaHR or MiHR. Criteria for MaHR specified in Outcome Measure 2. MiHR= <15% blasts in bone marrow and <15% blasts in peripheral blood (PB); <30% blasts+promyelocytes in bone marrow and <30% blasts+promyelocytes in PB; <20% basophils in PB; no extramedullary disease other than spleen and liver. Confirmed hematologic response = response confirmed ≥4 weeks after 1st documented event with no concomitant use of anagrelide or hydroxyurea.|Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during treatment; at end of treatment|Population comprised of responders only||days||Full Range|Median
704838|NCT00101647|Secondary|Median Time in Days From First Dosing Date to Date of MaHR|MaHR=best response of CHR or NEL. CHR=white blood cells ≤institutional upper limit of normal (iULN); absolute neutrophil count (ANC) ≥1000/mm3; platelets ≥100,000/mm3; no blasts/promyelocytes in peripheral blood (PB); bone marrow blasts ≤5%; <5% myelocytes+metamyelocytes in PB; PB basophils ≤ iULN; no extramedullary involvement. NEL=WBC ≤iULN; no blasts/promyelocytes in PB; bone marrow blasts ≤5%; <5% myelocytes+metamyelocytes in PB; PB basophils ≤iULN; no extramedullary involvement; at least 1 of: ANC ≥500/mm3 & <1000/mm3; platelets ≥20,000/mm3 & <100,000/mm3.|Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during treatment; at end of treatment|Population is comprised of responders only||Days||Full Range|Median
704839|NCT00101647|Secondary|Percentage of Participants Who Achieved OHR and Did Not Progress at 12 Months and 24 Months|Percentage of participants who achieved OHR and did not progress at specified timepoints, based on the Kaplan-Meier estimate of the duration of response. OHR=best confirmed response of MaHR or MiHR. MaHR criteria in Outcome Measure 2. MiHR= <15% blasts in bone marrow and <15% blasts in peripheral blood (PB); <30% blasts+promyelocytes in bone marrow and <30% blasts+promyelocytes in PB; <20% basophils in PB; no extramedullary disease other than spleen and liver. Confirmed hematologic response= confirmed ≥4 weeks after 1st documented event with no concomitant use of anagrelide or hydroxyurea.|12 months, 24 months|Population is comprised of responders only||Percentage of responders|||Number
706067|NCT00104637|Primary|6 Minute Walk Distance|The distance a subject walked within 6 minutes was measured and documented.|Period 1 and Period 3 ( within 8 weeks)|||meters||95% Confidence Interval|Least Squares Mean
704840|NCT00101647|Secondary|Percentage of Participants Who Achieved MaHR and Did Not Progress at 24 Months in the Imatinib-Resistant Group (Based on the Kaplan-Meier Estimate of the Duration of Response)|Percentage of participants in the Imatinib-Resistant Group who achieved MaHR and did not progress at Month 24, based on the Kaplan-Meier estimate of the duration of response. MaHR=best confirmed response of complete hematologic response (CHR) or No Evidence of Leukemia (NEL). Criteria for MaHR and NEL are specified in Outcome Measure 2.|24 months|Population comprised of responders only. NOTE: Projected duration of MaHR at 24 months in the Imatinib-Intolerant group was beyond the maximum observed time for this cohort, and therefore only the Imatinib-Resistant group is presented.||percentage of responders|||Number
704841|NCT00101647|Secondary|Percentage of Participants Who Achieved MaHR and Did Not Progress at 12 Months (Based on the Kaplan-Meier Estimate of the Duration of Response)|MaHR=best response of CHR or NEL. CHR=white blood cells ≤institutional upper limit of normal (iULN); absolute neutrophil count (ANC) ≥1000/mm3; platelets ≥100,000/mm3; no blasts/promyelocytes in peripheral blood (PB); bone marrow blasts ≤5%; <5% myelocytes+metamyelocytes in PB; PB basophils ≤ iULN; no extramedullary involvement. NEL=WBC ≤iULN; no blasts/promyelocytes in PB; bone marrow blasts ≤5%; <5% myelocytes+metamyelocytes in PB; PB basophils ≤iULN; no extramedullary involvement; at least 1 of: ANC ≥500/mm3 & <1000/mm3; platelets ≥20,000/mm3 & <100,000/mm3.|12 months|Population comprised of responders only.||percentage of responders|||Number
704842|NCT00101647|Primary|Major and Overall Hematologic Response (MaHR and OHR)|MaHR=best confirmed response of complete hematologic response (CHR) or No Evidence of Leukemia (NEL). OHR=best confirmed response of MaHR or minor hematologic response (MiHR). Confirmed hematologic response=response confirmed ≥4 weeks after first documented event with no concomitant use of anagrelide or hydroxyurea. Maintaining a response=no 2 consecutive records of nonresponse at assessment. Criteria for CHR and NEL specified in Outcome Measure 2 and criteria for MiHR in Outcome Measure 4.|Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during treatment; at end of treatment|All treated subjects||participants|||Number
704843|NCT00101660|Secondary|Blood Sample Collection for Pharmacokinetic (PK) Analysis of Dasatinib|Blood samples were collected for PK to be included in separate population PK analyses.|Day 8 of study; pretreatment through sample between 30 minutes and 3 hours following treatment, a sample between 5 hours and 8 hours following treatment and a sample at 12 hours, prior to the next dose.|No study-specific PK analyses were planned for this report.||Participants|||Number
704844|NCT00101660|Secondary|Number of Imitanib-resistant Participants With Drug-related AEs, Death Within 30 Days of Last Dose, Death, AEs Leading to Discontinuation, SAEs, Grade 3-4 Thrombocytopenia, Grade 3-4 Neutropenia, and Any AE|AE=any new untoward medical occurrence or worsening of a preexisting medical condition regardless of causal relationship with treatment. SAE=any untoward medical occurrence at any dose that: results in death; is life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability; is cancer; is congenital anomaly/birth defect; results in drug dependency/abuse; is an important medical event. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death)|Continuously, from baseline through 2 years|All imitanib-resistant participants who received treatment.||Participants|||Number
704845|NCT00101660|Secondary|Number of Imitanib-intolerant Participants With Drug-related Adverse Events (AEs), Death Within 30 Days of Last Dose, Death, and AEs Leading to Discontinuation, Serious Adverse Events (SAEs), Grade 3-4 Thrombocytopenia, Grade 4-4 Neutropenia, and Any AE|AE=any new untoward medical occurrence or worsening of a preexisting medical condition regardless of causal relationship with treatment. SAE=any untoward medical occurrence at any dose that: results in death; is life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability; is cancer; is congenital anomaly/birth defect; results in drug dependency/abuse; is an important medical event. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death)|Continuously, from baseline through 2 years|All imitanib-intolerant participants who received treatment.||Participants|||Number
704846|NCT00101660|Secondary|Minimal Clinically Significant Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) Questionnaire Scores|Health-related quality of life as measured by FACT-G, which comprises 27 questions in 4 domains: PWB, SWB, EWB, FWB. Total FACT-G score=summation of the 4 subscale scores and ranges from 0 to 108. Higher scores=better health-related quality of life. Total Score change of 7 or more=minimal clinical important change; PWB, EWB, & FWB score change of 3 or more, and SWB score change of 2 or more=minimal clinical important change. Baseline FACT-G measurements can be found in Baseline Characteristics.|Baseline, Day 29, every 4 weeks for the first 24 weeks, then every 12 weeks for the remainder of treatment, after end of treatment. Treatment continued until disease progression or development of toxicity or until other protocol-defined criteria.|Number of participants with assessments at baseline and timepoint||Participants|||Number
704847|NCT00101660|Secondary|Number of Participants With Major Molecular Response (MMR)|MMR is defined as ≤3 log reduction in BCR-ABL levels from the standardized baseline value of BCR-ABL:Control Gene ratio. The international ratio is obtained by multiplying BCR-ABL:Control gene ratio by the lab-specific conversion factor.|Baseline to 2 years|All participants who received treatment.||Participants|||Number
704848|NCT00101660|Secondary|Median Time From First Dosing Until CHR|CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets <450,000/mm^3; no blasts or promyelocytes in peripheral blood; <5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils ≤20%; no extramedullary involvement. Response, as defined, must be maintained for at least 4 weeks after first documented. A CHR could begin only 14 days after dosing start date.|Baseline (within 72 hours of start of therapy), weekly until Week 12, every 3 months until off-study|Population limited to responders (those achieving CHR) only||Months||Full Range|Median
704849|NCT00101660|Secondary|Percentage of Participants Who Acheived CHR and Did Not Progress at 12 Months and 24 Months|Based on the Kaplan-Meier estimate of the duration of response. CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets < 450,000/mm^3; no blasts or promyelocytes in peripheral blood; <5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils ≤20%; no extramedullary involvement. Response, as defined, must be maintained for at least 4 weeks after first documented. A CHR could begin only 14 days after dosing start date.|12 and 24 months|Population limited to responders (those achieving CHR) only||Percentage of participants|||Number
704850|NCT00101660|Secondary|Number of Participants With Complete Hematologic Response (CHR)|CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets <450,000/mm^3; no blasts or promyelocytes in peripheral blood; <5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils ≤20%; no extramedullary involvement. Response, as defined, must be maintained for at least 4 weeks after first documented. A CHR could begin only 14 days after dosing start date.|Baseline (within 72 hours of start of therapy), weekly until Week 12, every 3 months until off-study|All participants who received treatment.||Participants|||Number
704851|NCT00101660|Secondary|Median Time From First Dosing Date to Date of MCyR|MCyR is the combination of CCyR-0% Ph+ metaphases and PCyR - 1% to 35% Ph+ metaphases.|Baseline (within 4 weeks of Day 1) and every 12 weeks|Population is limited to responders (those who acheived MCyR) only||Months||Full Range|Median
704852|NCT00101660|Secondary|Percentage of Participants Who Achieved MCyR and Did Not Progress at 12 and 24 Months|Based on the Kaplan-Meier estimate of the duration of response. Determination of cytogenetic response was based on the prevalence of Ph+ metaphases among cells with metaphases in a bone marrow sample. MCyR is the combination of Complete Cytogenetic Response (CCyR)-0% Ph+ metaphases and Partial Cytogenetic Response (PCyR) - 1% to 35% Ph+ metaphases.|12 and 24 Months|Population is limited to responders (those who acheived MCyR) who were also assessed for duration of MCyR.||Percentage of participants|||Number
704853|NCT00101660|Secondary|Number of Imatinib-intolerant Participants With MCyR|Determination of cytogenetic response was based on the prevalence of Ph+ metaphases among cells with metaphases in a bone marrow sample. MCyR is the combination of CCyR-0% Ph+ metaphases and PCyR - 1% to 35% Ph+ metaphases.|Baseline to 2 years|All imatinib-intolerant participants who received treatment.||Participants|||Number
704854|NCT00101660|Primary|Number of Imatinib-resistant Participants With Major Cytogenetic Response (MCyR)|Cytogenetic response was based on the prevalence of Ph+ metaphases among cells with metaphases in a bone marrow sample. MCyR is the combination of Complete Cytogenetic Response (CCyR)-0% Ph+ metaphases plus Partial Cytogenetic Response (PCyR)-1% to 35% Ph+ metaphases.|2 years|All imatinib-resistant participants who received treatment.||Participants|||Number
704855|NCT00101686|Secondary|Overall Relative Dose Intensity of Irinotecan|Relative dose intensity for a cycle was calculated as the percentage of the actual dose intensity of the cycle divided by the planned dose intensity of the cycle. Overall relative dose intensity was calculated as the average relative dose intensities over all cycles. (Dose intensity for each cycle was calculated as the actual dose level of the study medication received in that cycle divided by the number of weeks in the cycle.)|End of treatment cycle|As-Treated population||percent dose intensity||Standard Error|Mean
704856|NCT00101686|Secondary|Dose Reduction Due to Treatment Emergent Adverse Events|Number of subjects that had at least one Treatment-Emergent Adverse Event (TEAE) that led to a dose reduction. TEAE includes all reported Adverse Events that occurred within 30 days of last study medication.|Day 1; Day 8; and at end of every 3 treatment cycles for FOLFIRI; end of every 2 cycles for mIRI|As-Treated population - all subjects who received any study medication, with treatment assignments designated according to actual study treatment received.||participants|||Number
704857|NCT00101686|Secondary|Survival Time at Last Follow-Up Visit: Bevacizumab With FOLFIRI, mIFL|Survival time defined as time from date of randomization to date of death. In the absence of confirmation of death, survival time was censored to last date the subject known to be alive. Zero subjects analyzed indicates median could not be analyzed based on number of subjects who died.|Last Follow-Up Visit|ITT Population.||months||95% Confidence Interval|Median
704858|NCT00101686|Secondary|1 Year Survival: Bevacizumab With FOLFIRI, mIFL|Number of patients alive or dead at 1 year. In the absence of confirmation of death, survival time was censored to last date the subject known to be alive.|1 year from date of randomization|ITT Population.||participants|||Number
704859|NCT00101686|Secondary|Overall Response: Bevacizumab With FOLFIRI, mIFL|A subject will be considered achieving an overall response if the subject has a sustained CR or PR for at least 4 weeks, confirmed by tumor assessments. (Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): ≥ 30% decrease in the sum of the LD of target lesions, taking as reference the Pre-treatment sum LD. )|every 6 weeks during chemotherapy until disease progression|ITT population.||participants|||Number
704860|NCT00101686|Secondary|Time to Progression: Bevacizumab With FOLFIRI, mIFL|Time to disease progression is defined as the number of months from date of randomization to the date of first documentation of disease progression (PD).|every 6 weeks until disease progression|ITT population.||months||95% Confidence Interval|Median
704861|NCT00101686|Secondary|Survival Time: Celecoxib and Placebo|Survival time defined as time from date of randomization to date of death. In the absence of confirmation of death, survival time was censored to last date the subject known to be alive.|assessed at least every week during treatment and at least every 3 months during follow-up|ITT Population. Celecoxib participants were combined from FOLFIRI, mIRI, and Capecitabine treatments (not bevacizumab); Placebo participants were combined from FOLFIRI, mIRI, and Capecitabine treatments (not bevacizumab).||months||95% Confidence Interval|Median
704862|NCT00101686|Secondary|Overall Response: Celecoxib and Placebo|A subject will be considered achieving an overall response if the subject has a sustained CR or PR for at least 4 weeks, confirmed by tumor assessments. (Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): ≥ 30% decrease in the sum of the LD of target lesions, taking as reference the Pre-treatment sum LD. )|every 6 weeks during chemotherapy until disease progression|ITT Population. Celecoxib participants were combined from FOLFIRI, mIRI, and Capecitabine treatments (not bevacizumab); Placebo participants were combined from FOLFIRI, mIRI, and Capecitabine treatments (not bevacizumab).||participants|||Number
704863|NCT00101686|Secondary|Time to Progression : Celecoxib and Placebo|Time to disease progression is defined as the number of months from date of randomization to the date of first documentation of disease progression (PD).|every 6 weeks until disease progression|ITT Population. Celecoxib participants were combined from FOLFIRI, mIRI, and Capecitabine treatments (not bevacizumab); Placebo participants were combined from FOLFIRI, mIRI, and Capecitabine treatments (not bevacizumab).||months||95% Confidence Interval|Median
704864|NCT00101686|Secondary|1 Year Survival: FOLFIRI, mIFL and CapeIRI|Number of patients alive or dead at 1 year. In the absence of confirmation of death, survival time was censored to last date the subject known to be alive.|1 year from date of randomization|ITT Population.||participants|||Number
704867|NCT00101686|Secondary|Time to Progression: FOLFIRI, mIFL and CapeIRI|Time to disease progression is defined as the number of months from date of randomization to the date of first documentation of disease progression (PD).|every 6 weeks until disease progression|ITT Population.||months||95% Confidence Interval|Median
704868|NCT00101686|Primary|Time to Progression (TTP) at Primary Completion: FOLFIRI and mIFL|Time to disease progression is defined as the number of months from date of randomization to the date of first documentation of disease progression (PD).|every 6 weeks until disease progression|Intent-to-Treat Population (ITT) - all subjects who were randomized, with study drug assignment designated according to initial randomization, regardless of whether subjects received any study drug or received a different drug from that to which they were randomized.||months||95% Confidence Interval|Median
704869|NCT00101816|Secondary|Population PK of Dasatinib|Population pharmacokinetic analysis was not done because it is not meaningful for this single study|Day 8 immediately prior to the first daily dose and between 30 minutes to 3 hours following this dose.|||population pk|||Number
704870|NCT00101816|Secondary|Pharmacokinetics (PK) of Dasatinib and Its Metabolite BMS-582691 - Plasma Half-life (T-HALF)|The T-HALF was calculated as Ln2/Lz,where Lz was the absolute value of the slope of the terminal log-linear phase.|Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours.|26 participants had dense PK sampling on Day 1 & Day 8; parameters for 1 participant on Day 1 & 1 on Day 8 were excluded due to unreliable data. Participants w/all concentration-time values <than limit of quantitation were treated as missing for PK analysis. n=participants included in the statistical analyses of PK on Day 1 and Day 8, respectively.||hours||Standard Deviation|Mean
704871|NCT00101816|Secondary|Pharmacokinetics (PK) of Dasatinib's Metabolite BMS-582691 - Time to Maximum Observed Plasma Concentration (Tmax)|The Tmax was obtained from experimental observations. Using no weighting factor, the terminal log-linear phase of the concentration-time curve was identified by least-square linear regression of at least 3 data points that yielded a maximum G-criteria,which is also referred to as adjusted R-squared.|Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours.|26 participants had dense PK sampling on Day 1 & Day 8; parameters for 1 participant on Day 1 & 1 on Day 8 were excluded due to unreliable data. Participants w/all concentration-time values <than limit of quantitation were treated as missing for PK analysis. n=participants included in the statistical analyses of PK on Day 1 and Day 8, respectively.||hours||Standard Deviation|Mean
704872|NCT00101816|Secondary|Pharmacokinetics (PK) of Dasatinib's Metabolite BMS-582691 - Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Time Point Within the Dosing Interval of 12 h (AUC[0-T])|The AUC(0-T) was calculated using the mixed log-linear trapezoidal algorithm in Kinetica™. In the calculation of AUC(0-T), predose concentrations that were less than the lower limit of quantitation (LLQ) were assigned a value of zero.|Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours.|26 participants had dense PK sampling on Day 1 & Day 8; parameters for 1 participant on Day 1 & 1 on Day 8 were excluded due to unreliable data. Participants w/all concentration-time values <than limit of quantitation were treated as missing for PK analysis. n=participants included in the statistical analyses of PK on Day 1 and Day 8, respectively.||ng∙h/mL||Standard Deviation|Mean
704873|NCT00101816|Secondary|Pharmacokinetics (PK) of Dasatinib's Metabolite BMS-582691 - Maximum Observed Plasma Concentration (Cmax)|The Cmax was obtained from experimental observations. Using no weighting factor, the terminal log-linear phase of the concentration-time curve was identified by least-square linear regression of at least 3 data points that yielded a maximum G-criteria,which is also referred to as adjusted R-squared.|Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours.|26 participants had dense PK sampling on Day 1 & Day 8; parameters for 1 participant on Day 1 & 1 on Day 8 were excluded due to unreliable data. Participants w/all concentration-time values <than limit of quantitation were treated as missing for PK analysis. n=participants included in the statistical analyses of PK on Day 1 and Day 8, respectively.||ng/mL||Standard Deviation|Mean
704874|NCT00101816|Secondary|Pharmacokinetics (PK) of Dasatinib - Plasma Half-life (T-HALF)|The T-HALF was calculated as Ln2/Lz,where Lz was the absolute value of the slope of the terminal log-linear phase.|Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours.|26 participants had dense PK sampling on Day 1 and Day 8; parameters for 1 participant on Day 8 was excluded due to unreliable data. Participants with all concentration-time values < than the limit of quantitation were treated as missing for PK analysis. n= participants included in the statistical analyses of PK on Day 1 and Day 8, respectively.||hours||Standard Deviation|Mean
704875|NCT00101816|Secondary|Pharmacokinetics (PK) of Dasatinib - Time to Maximum Observed Plasma Concentration (Tmax)|The Tmax was obtained from experimental observations. Using no weighting factor, the terminal log-linear phase of the concentration-time curve was identified by least-square linear regression of at least 3 data points that yielded a maximum G-criteria,which is also referred to as adjusted R-squared.|Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours.|26 participants had dense PK sampling on Day 1 and Day 8; parameters for 1 participant on Day 8 was excluded due to unreliable data. Participants with all concentration-time values < than the limit of quantitation were treated as missing for PK analysis. n= participants included in the statistical analyses of PK on Day 1 and Day 8, respectively.||hours||Standard Deviation|Mean
704917|NCT00102063|Other Pre-specified|Change in Pediatric Quality of Life Enjoyment and Satisfaction (PQLES) Questionnaire Total Score|"Change from baseline to last observed post-baseline value in PQLES total score, using the last observation carried forward.
Scale consists of 14 items pertaining to daily life activities and satisfaction, and an overall assessment item. Each item will be rated on a five-point scale (1=very poor, 2=poor, 3=fair, 4=good, 5=very good) with a minimum score of 14 (better outcome) and a maximum score of 70 (worse outcome)."|Baseline and Day 42|||points||Standard Error|Mean
704876|NCT00101816|Secondary|Pharmacokinetics (PK) of Dasatinib - Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Time Point Within the Dosing Interval of 12 h or 24 h(AUC[0-T])|The AUC(0-T) was calculated using the mixed log-linear trapezoidal algorithm in Kinetica™. In the calculation of AUC(0-T), predose concentrations that were < lower limit of qualtitation were assigned a value of zero.|Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours.|26 participants had dense PK sampling on Day 1 and Day 8; parameters for 1 participant on Day 8 was excluded due to unreliable data. Participants with all concentration-time values < than the limit of quantitation were treated as missing for PK analysis. n= participants included in the statistical analyses of PK on Day 1 and Day 8, respectively.||ng∙h/mL||Standard Deviation|Mean
704877|NCT00101816|Secondary|Pharmacokinetics (PK) of Dasatinib - Maximum Observed Plasma Concentration (Cmax)|The Cmax was obtained from experimental observations. Using no weighting factor, the terminal log-linear phase of the concentration-time curve was identified by least-square linear regression of at least 3 data points that yielded a maximum G-criteria,which is also referred to as adjusted R-squared.|Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours.|26 participants had dense PK sampling on Day 1 and Day 8; parameters for 1 participant on Day 8 was excluded due to unreliable data. Participants with all concentration-time values < than the limit of quantitation were treated as missing for PK analysis. n= participants included in the statistical analyses of PK on Day 1 and Day 8, respectively.||ng/mL||Standard Deviation|Mean
704878|NCT00101816|Secondary|Deaths, Serious Adverse Events (SAEs), Adverse Events (AEs), AEs Leading to Discontinuation, Drug-Related AEs|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition regardless of causal relationship with treatment. SAE=any untoward medical occurrence at any dose that: results in death; is life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability; is cancer; is congenital anomaly/birth defect; results in drug dependency/abuse; is an important medical event. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death)|Continuously throughout study, from pre-treatment visit through end of study (due to death, unacceptable toxicity, treatment failure, etc) and follow-up period|All treated subjects||Participants|||Number
704879|NCT00101816|Secondary|Minimally Significant Changes From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G)|Number of subjects with minimally significant changes from baseline in the health-related quality of life questionnaire FACT-G. FACT-G=27 questions in 4 domains: physical, social/family, emotional, & functional well-being (PWB, SWB, EWB, FWB). Score range: 0-108; higher scores=better health-related quality of life. Total Score change of 7 or more=minimal clinical important change; PWB, EWB, & FWB score change of 3 or more, & SWB score change of 2 or more=minimal clinical important change.|Baseline, Every 2 weeks for the first 3 cycles, following every 4-week cycle, and once at follow-up|Number of participants with FACT-G assessments at baseline and at least one assessment during treatment||Participants|||Number
704880|NCT00101816|Secondary|MaHR and Major Cytogenetic Response (MCyR) Among Participants With Baseline BCR-ABL Point Mutations|MaHR and MCyR in subjects with mutations at baseline, including imatinib-resistant mutations (IRM) and specific BCR-ABL mutations (SBAM). Criteria for MaHR are specified in Outcome Measure 2. MCyR=rate of complete cytogenetic responses + the rate of partial cytogenetic responses, as defined in Outcome Measure 5. BCR-ABL=the fused gene found in subjects with this type of CML. This table contains those mutations observed in at least 3 participants. The categories “1 IRM w/2-4-fold increase in resistance” and “≥1 IRM w/≥5-fold increase in resistance” refer to increase in resistance to imatinib.|baseline, at time of disease progression|All subjects with baseline mutation data; n=the number of participants with the specified mutation. Baseline mutation data were reported for 103 of the 109 subjects (10/10 imatinib-intolerant and 93/99 imatinib-resistant). At baseline, 39 (42%) imatinib-resistant subjects and 3 imatinib-intolerant subject had imatinib-resistant mutations||Percentage of Participants|||Number
704881|NCT00101816|Secondary|Number of Participants Achieving Major Molecular Response (MMR)|Number of participants who achieved an MMR at any time during the treatment period. MMR was calulated by measuring BCR-ABL transcripts in blood during treatment using quantitative reverse transcription-polymerase chain reaction (RT-PCR). BCR-ABL=the fused gene found in subjects with this type of Chronic Myeloid Leukemia (CML).|Baseline, every 12 weeks, and at time of Complete Cytogenetic Response (CCyR) for quantitative Polyermase Chain Reaction (qPCR) analysis|treated participants with or without CCyR who were assessed for major molecular response||participants|||Number
704882|NCT00101816|Secondary|Number of Participants With CHR or NEL, MiHR, or no Hematologic Response|Best confirmed hematologic response. Confirmed hematologic response=response that is confirmed after at least 4 weeks with no concomitant use of anagrelide or hydroxyurea use during this interval. Criteria for complete hematologic response (CHR) or No Evidence of Leukemia (NEL) are specified in Outcome Measure 2. Criteria for minor hematologic response (MiHR) are specified in Outcome Measure 1.|Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during Cycles 1 and 2; After every 2nd cycle for Cycles 3+; at end of treatment|All treated subjects||Participants|||Number
704883|NCT00101816|Secondary|Number of Participants With Complete, Partial, Minor, Minimal, or No Cytogenetic Response|Best confirmed cytogenetic response. Determination of cytogenetic response is based on the prevalence (percentage) of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase in a bone marrow sample (aspirates/biopsies).|Baseline (within 4 weeks of therapy start); Every month for Cycles 1-3; Every 12 weeks for Cycles 4+; end of treatment|All treated subjects||Participants|||Number
704884|NCT00101816|Secondary|Time to MaHR and OHR|Median time from first dosing to date of OHR and/or MaHR in subjects who achieved OHR and MaHR. MaHR=best confirmed response of complete hematologic response (CHR) or No Evidence of Leukemia (NEL). OHR=best confirmed response of MaHR or minor hematologic response (MiHR). Criteria for MaHR are specified in Outcome Measure 2. Criteria for MiHR are specified in Outcome Measure 1.|Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during Cycle 1 and 2; After every 2nd cycle during Cycles 3+; at end of treatment|Participants who achieved OHR and MaHR||days||95% Confidence Interval|Median
706068|NCT00104637|Secondary|Pulmonary Function FVC (Forced Vital Capacity)|Data to calculate results for FVC was based on Period 1.|Period 1 (4 weeks)|||liters||95% Confidence Interval|Least Squares Mean
704885|NCT00101816|Secondary|Median Duration of Overall Hematologic Response (OHR)|OHR=best confirmed response of MaHR or MiHR. MaHR=best confirmed response of complete hematologic response (CHR) or No Evidence of Leukemia (NEL). Criteria for MaHR are specified in Outcome Measure 2. Criteria for MiHR are specified in Outcome Measure 1. Maintaining a response was defined as no 2 consecutive records of non-response (ie, a single record of non-response between 2 assessments of response was not considered a loss of response).|Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during Cycle 1 and 2; After every 2nd cycle during Cycles 3+; at end of treatment|Participants who achieved OHR||months||95% Confidence Interval|Median
704886|NCT00101816|Secondary|Median Duration of Major Hematologic Response (MaHR)|MaHR=best confirmed response of CHR or NEL. CHR=white blood cells ≤ institutional upper limit of normal (iULN); absolute neutrophil count (ANC) ≥1000/mm3; platelets ≥100,000/mm3; no blasts/promyelocytes in peripheral blood (PB); bone marrow blasts ≤5%; <5% myelocytes+metamyelocytes in PB; PB basophils ≤ iULN; no extramedullary involvement. NEL=WBC ≤ iULN; no blasts/promyelocytes in PB; bone marrow blasts ≤5%; <5% myelocytes+metamyelocytes in PB; PB basophils ≤ iULN; no extramedullary involvement; at least 1 of the following: ANC ≥500/mm3 & <1000/mm3; platelets ≥20,000/mm3 & <100,000/mm3.|Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during Cycle 1 and 2; After every 2nd cycle during Cycles 3+; at end of treatment|Participants who achieved MaHR||months||Full Range|Median
704887|NCT00101816|Primary|Major and Overall Hematologic Response (MaHR and OHR)|MaHR=best confirmed response of complete hematologic response (CHR) or No Evidence of Leukemia (NEL). Criteria for MaHR are specified in Outcome Measure 2. OHR=best confirmed response of MaHR or minor HR (MiHR). MiHR= <15% blasts in bone marrow and <15% blasts in peripheral blood (PB); <30% blasts + promyelocytes in bone marrow and <30% blasts + promyelocytes in PB; <20% basophils in PB; no extramedullary disease other than spleen and liver. Confirmed hematologic response=response confirmed ≥4 weeks after first documented event with no concomitant use of anagrelide or hydroxyurea.|Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during Cycle 1 and 2; After every 2nd cycle during Cycles 3+; at end of treatment|All treated subjects||Participants|||Number
704888|NCT00101868|Secondary|Physician Time Spent to Complete the Discharge Application||averaged over 2 years of patient enrollment||||||
704889|NCT00101868|Secondary|Number of Emergency Department Visits|Number of participants with at least one emergency department visit within six months after discharge|within 6 months after discharge|intention to treat||participants|||Number
704890|NCT00101868|Secondary|Number of Outpatient Visits||within 6 months after discharge||||||
704891|NCT00101868|Secondary|Discharge Physician Satisfaction With Discharge Process||6 months after using discharge process||||||
704892|NCT00101868|Secondary|Primary Care Physician's Perception, Satisfaction||10 days after discharge||||||
704893|NCT00101868|Secondary|Primary Care Physician's Perception, Effectiveness||10 days after discharge||||||
704894|NCT00101868|Secondary|Patient's Satisfaction With Drug Information||1 week after discharge||||||
704895|NCT00101868|Secondary|At Least One Adverse Event Within One Month After Discharge|Number of participants with at least one adverse event within one month after discharge|1 month after discharge|intention to treat||participants|||Number
704896|NCT00101868|Secondary|Pharmacist's Satisfaction With Discharge Prescription||1 day after discharge||||||
704897|NCT00101868|Secondary|Pharmacist Needed to Clarify the Discharge Prescription||1 day after discharge||||||
704898|NCT00101868|Secondary|Patients' Perception of Discharge Process, Satisfaction||1 week after discharge||||||
704899|NCT00101868|Secondary|Patients' Perception of Discharge Process, Effectiveness, Satisfaction, Preparedness||1 week after discharge||||||
704900|NCT00101868|Primary|Hospital Readmission, at Least One|Number of participants with at least one readmission within 6 months after discharge from index hospital visit|within 6 months after discharge|Analysis was intention to treat. All 631 patient participants assigned to interventions were analyzed||participants|||Number
704901|NCT00101907|Primary|Participant Incidence of Adverse Events|The number of participants who experienced at least one treatment-emergent adverse event. Additional details regarding specfic adverse events are provided in the Adverse Event section of this posting.|From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days.|Safety Analysis Set, composed of all participants in the AMG 706 treatment groups who received at least one dose of AMG 706 and all participants in the panitumumab-only treatment group who received at least one dose of panitumumab.||Participants|||Number
704902|NCT00101907|Secondary|AUC0-inf|Area under the concentration-time curve from time 0 to infinite time (AUC0-inf) postdose with AMG 706. AUC0-inf was estimated using the linear/log trapezoidal method. AUC0-inf was not calculated for the BID cohort.|Day 1, pre-dose and at 1, 3, 6,12 (BID cohort only) and 24 hours post-dose.|PK analysis set. Patients with elevated AMG 706 concentrations at 24 hours were excluded from the AUC summary statistics calculations.||μg*hr/mL||Standard Deviation|Mean
704903|NCT00101907|Secondary|AUC0-24|Area under the plasma concentration-time curve from time 0 to 24 hours postdose (AUC0-24) with AMG 706. AUC0-24 was estimated using the linear/log trapezoidal method. For the BID cohort, AUC0 24 was estimated as 2 times the AUC from time 0 to 12 hours post the first daily dose (AUC0-12) using the linear/log trapezoidal method.|Day 1, pre-dose and at 1, 3, 6,12 (BID cohort only) and 24 hours post-dose.|PK Analysis set; Patients with elevated AMG 706 concentrations at 24 hours were excluded from the AUC summary statistics calculations.||μg*hr/mL||Standard Deviation|Mean
704904|NCT00101907|Secondary|Cmax|The maximum observed plasma concentration after AMG 706 dosing|Day 1, pre-dose and at 1, 3, 6,12 (BID cohort only) and 24 hours post-dose.|PK analysis set.||ng/mL||Standard Deviation|Mean
704905|NCT00101907|Secondary|Tmax|Time after dosing when maximum plasma concentration was observed for AMG 706|Day 1, pre-dose and at 1, 3, 6,12 (BID cohort only) and 24 hours post-dose.|The Pharmacokinetic (PK) Analysis Set consists of patients who had dosing and PK sampling times recorded on the day of PK sample collection and no significant protocol deviations that impacted the quality of the PK data (for example, sample processing errors and/or inaccurate dosing on the day of the PK sampling).||hours||Full Range|Median
704944|NCT00102596|Secondary|Blood Plasma Levels of Octanoic Acid After 64 mg/kg 1-Octanol Dose|Octanoic Acid is a metabolite of 1-octanol. Blood plasma levels of octanoic acid were measured at 5, 20, 45, 70, 100, 130, 160, 210, 270 and 360 minutes post-dose.|5, 20, 45, 70, 100, 130, 160, 210, 270 and 360 minutes post-dose|All participants who received either formulation 64 mg/kg 1-octanol in Part A or B||ng/ml||Standard Deviation|Mean
704906|NCT00101907|Secondary|Number of Participants With an Objective Tumor Response|The number of participants with a confirmed objective tumor response, defined as a complete response (CR) or partial response (PR) throughout based on modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Any CR or PR was to be confirmed 4 to 6 weeks after the initial CR or PR.|From enrollment until date of last follow-up visit. The median follow-up time was 24 weeks, with a range of 3 to 73 weeks.|Efficacy Analysis Set, defined as defined as patients who received at least 1 dose of AMG 706 for AMG 706 treatment groups and patients who received at least 1 dose of panitumumab for the panitumumab-only treatment group.||participants|||Number
704907|NCT00101933|Other Pre-specified|Change in Most Severe Seizures|"Seizures were recorded on daily seizure diaries. The subject recorded the number of seizures by seizure type on the seizure diary. The subject also noted at baseline, of those they had ever experienced, which seizure they considered to be most severe."|Through the end of the three-month blinded phase|"This analysis used the Primary analysis data set. In addition, the protocol prespecified that if a subject did not experience the severe seizure in the baseline phase that they would not be included in the calculation of the blinded phase median seizure frequency percentage change from baseline."||Percentage change from baseline||Inter-Quartile Range|Median
704908|NCT00101933|Primary|Alternative Primary Analysis: Change in Seizure Rate|A generalized estimating equations (GEE) analysis was used to evaluate the treatment effect on seizure frequency. With one outlier subject removed, the GEE model for this alternative analysis included treatment effect, log of the baseline seizure count, log of age, visit (categorical), and the offset (the number of days the diary was recorded in each month).|Through the end of the three-month blinded phase|"This analysis used the protocol-prespecified Primary analysis data set with one additional outlier subject removed from the active group. This subject had 210 stimulation initiated seizures within 48 hours of the device being turned on and was determined to be an outlier using both a statistical and clinical rationale."||Percentage change from baseline||Inter-Quartile Range|Median
704909|NCT00101933|Secondary|Proportion of Treatment Failures|A treatment failure was defined in the protocol as a subject who 1) required 3 or more doses of rescue medication within 48 hours, 3 times during the blinded phase; or 2) had 3 episodes of convulsive status epilepticus during the blinded phase.|Through the end of the three-month blinded phase|"This analysis used the Primary analysis data set which required that subjects had at least 70 days of diary in the blinded phase. One control subject was not included in this analysis as they had 66 of the required 70 days."||participants|||Number
704910|NCT00101933|Secondary|Percentage Change in the Maximum Length of Seizure-free Intervals|Difference between active group and control group in percentage change in the maximum length of seizure-free intervals over the entire blinded phase as compared to the entire baseline phase.|Through the end of the three-month blinded phase|"This analysis used the Primary analysis data set which required that subjects had at least 70 days of diary in the blinded phase. One control subject was not included in this analysis as they had 66 of the required 70 days."||Percentage change from baseline||Inter-Quartile Range|Median
704911|NCT00101933|Secondary|Change in Percentage of Days Seizure-free|Difference between active group and control group in percentage change in seizure-free days over the entire blinded phase as compared to the entire baseline phase. The number of seizure-free days was normalized to 84-day baseline and blinded phases for each subject.|Through the end of the three-month blinded phase|"This analysis used the Primary analysis data set which required that subjects had at least 70 days of diary in the blinded phase. In addition, percentage change was not calculated for subjects who had no seizure-free days during the baseline phase."||Percentage change from baseline||Inter-Quartile Range|Median
704912|NCT00101933|Secondary|Seizure Responder Rate|A responder is defined as a subject with greater than or equal to 50% reduction in seizures as compared with baseline.|Through the end of the three-month blinded phase|"This analysis used the Primary analysis data set which required that subjects had at least 70 days of diary in the blinded phase. One control subject was not included in this analysis as they had 66 of the required 70 days."||Number of participants|||Number
704913|NCT00101933|Secondary|Incidence of Sudden Unexplained Death in Epilepsy (SUDEP)|"The number presented is for Definite and Probable SUDEP. The rate is calculated per 1000 subject years of follow-up. The confidence interval is the 95% Poisson confidence interval. Per protocol, only definite and probable SUDEP classifications were included in the calculation.
The results shown are for the entire study follow-up after device implantation."|Inclusive of all study follow-up after device implantation (mean follow-up 3.7 years)|This analysis used all subjects who were implanted and received stimulation. One subject was implanted but was not subsequently randomized, but did receive stimulation. This subject has been included for the purposes of this analysis for a total of 110 subjects included in this analysis.||Number of subjects experiencing SUDEP|||Number
704914|NCT00101933|Secondary|Adverse Events Experienced With the Medtronic DBS System|"The results are for the follow-up after device implantation through Year 2 and summarized are events that occurred in greater than 5% of subjects. Only events related to the device, therapy, or surgery are included. These abbreviations were used:
General dis...=General disorders and administration site conditions
Injury, poison...=Injury, poisoning and procedural complications
Ther.=Therapeutic.
For this summary, adverse events are reported as 'MedDRA System Organ Class - adverse event'."|Through Year 2 of the long-term follow-up phase|This analysis used all subjects who were implanted and received stimulation. One subject was implanted but was not subsequently randomized, but did receive stimulation. This subject has been included for the purposes of this analysis for a total of 110 subjects, as opposed to the 109 stated in the participant flow.||participants|||Number
704915|NCT00101933|Primary|Primary Analysis: Change in Seizure Rate|A protocol-prespecified generalized estimating equations (GEE) analysis was used to evaluate the treatment effect on seizure frequency. The final GEE model for the primary objective evaluation included treatment effect, log of the baseline seizure count, log of age, visit (categorical), treatment-by-visit interaction (categorical), and the offset (the number of days the diary was recorded in each month).|Through the end of the three-month blinded phase|"This analysis used the protocol-prespecified Primary analysis data set which required that subjects had at least 70 days of diary in the blinded phase. One control subject was not included in this analysis as they had 66 of the required 70 days."||Percentage change from baseline||Inter-Quartile Range|Median
704916|NCT00102063|Other Pre-specified|Patients Achieving Remission|The number of subjects achieving remission. Remission was defined as a score of mild or less (≤ 3) for items P1, P2, P3, N1, N4, N6, G5, and G9 in the PANSS score.|Baseline and Day 42|||participants|||Number
704918|NCT00102063|Secondary|Change in Children’s Global Assessment Scale (CGAS) Score|"Change from baseline to last observed post-baseline value in CGAS score, using the last observation carried forward.
Scale is a 100-point scale measuring psychological, social, and school functioning for children aged 6 to 17 years. Minimum scores ranged from 1-10, representing the need for constant supervision (worse outcome) to maximum scores of 91-100, representing superior functioning (better outcome)."|Baseline and Day 42|||points||Standard Error|Mean
704919|NCT00102063|Secondary|Clinical Global Impression (CGI) Improvement Score|"Last observed post-baseline value in CGI improvement score, using the last observation carried forward.
Scale refers to the global impression of the subject with respect to improvement of the illness. The scale rates the subject's severity of illness from 0 (not rated) to 1 (least severe) to 7 (most severe)."|Baseline and Day 42|||points||Standard Error|Mean
704920|NCT00102063|Secondary|Change in Clinical Global Impression (CGI) Severity Score|"Change from baseline to last observed post-baseline value in CGI severity score, using the last observation carried forward.
Scale refers to the global impression of the subject with respect to severity of the illness. The scale rates the subject's severity of illness from 0 (not rated) to 1 (least severe) to 7 (most severe)."|Baseline and Day 42|||points||Standard Error|Mean
704921|NCT00102063|Secondary|Change in Positive and Negative Syndrome Scale (PANSS) Negative Subscale Score|"Change from baseline to last observed post-baseline value in PANSS Negative Subscale score, using the last observation carried forward.
Scale consists of 7 negative symptom constructs each to be rated on a 7- point scale of severity with 1 = absent to 7 = extreme. Minimum score is 7 which is best outcome; maximum score is 49 for worse outcome."|Baseline and Day 42|||points||Standard Error|Mean
704922|NCT00102063|Secondary|Change in Positive and Negative Syndrome Scale (PANSS) Positive Subscale Score|"Change from baseline to last observed post-baseline value in PANSS positive subscale score, using the last observation carried forward.
Scale consists of 7 positive symptom constructs each to be rated on a 7- point scale of severity with 1 = absent to 7 = extreme. Minimum score is 7 which is best outcome; maximum score is 49 for worse outcome."|Baseline and Day 42|||points||Standard Error|Mean
704923|NCT00102063|Primary|Change in Positive and Negative Syndrome Scale (PANSS) Total Score|"Change from baseline to last observed post-baseline value in PANSS total score, using the last observation carried forward.
This scale consists of symptom constructs (7 positive, 7 negative, 16 general psychopathology), each to be rated on a 7-point scale of severity with 1 being absent to 7 being extreme. Minimum score is 30 which is best outcome; maximum score is 210 for worse outcome."|Baseline and Day 42|||points||Standard Error|Mean
704924|NCT00102440|Secondary|Percentage of Subjects Requiring Treatment for Gout Flares Between Weeks 8 and 52.|The percentage of subjects requiring treatment for a gout flare between Weeks 8 and 52 of the double-blind treatment period was summarized. A subject who reported more than 1 gout flare during this period was counted only once.|Weeks 8 through 52|Analysis was performed on the ITT subjects who had at least one dose of study drug between Weeks 8 and 52.||percentage of subjects|||Number
704925|NCT00102440|Secondary|Change From Baseline in Total Number of Tophi at Final Visit in Subjects With Palpable Tophi at Screening.|Change in number of tophi/subject calculated for the subset of subjects with palpable tophi at Screening. If the tophi were not palpable at the Final Visit, total count was assumed to be 0. The timing of the final visit may have differed for each subject.|Baseline and Final Visit (up to 52 weeks)|Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug, had a baseline serum urate ≥8.0 mg/dL, and had palpable tophi at baseline. Missing data were not imputed.||number of tophi||Inter-Quartile Range|Median
704926|NCT00102440|Secondary|Change From Baseline in Total Number of Tophi at Week 52 in Subjects With Palpable Tophi at Screening.|The change from baseline at Week 52 in the total number of tophi per subject was calculated for the subset of subjects with palpable tophi at the Screening Visit. If the tophi were no longer palpable at the Week 52 visit, the total count was assumed to be zero.|Baseline and Week 52|Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug, had a baseline serum urate ≥8.0 mg/dL, and had palpable tophi at baseline. Missing data were not imputed.||number of tophi||Inter-Quartile Range|Median
704927|NCT00102440|Secondary|Change From Baseline in Total Number of Tophi at Week 28 in Subjects With Palpable Tophi at Screening.|The change from baseline at Week 28 in the total number of tophi per subject was calculated for the subset of subjects with palpable tophi at the Screening Visit. If the tophi were no longer palpable at the Week 28 visit, the total count was assumed to be zero.|Baseline and Week 28|Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug, had a baseline serum urate ≥8.0 mg/dL, and had palpable tophi at baseline. Missing data were not imputed.||number of tophi||Inter-Quartile Range|Median
704928|NCT00102440|Secondary|Percent Change From Baseline in Tophus Size at Final Visit, as Determined by Physical Measurement, in Subjects With a Palpable Primary Tophus at Screening.|Percent change in primary tophus size was calculated as [(Final Visit - baseline sizes)/baseline]*100 for the subset of subjects with a primary palpable tophus at Screening. If tophus was not palpable at Final visit, the size was assumed to be 0. The timing of the final visit may have differed for each subject.|Baseline and Final Visit (up to 52 weeks)|Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug, had a baseline serum urate ≥8.0 mg/dL, and had a palpable primary tophus measured at baseline. Missing data were not imputed.||percent change from baseline||Inter-Quartile Range|Median
704929|NCT00102440|Secondary|Percent Change From Baseline in Tophus Size at Week 52, as Determined by Physical Measurement, in Subjects With a Palpable Primary Tophus at Screening.|The percent change from baseline in primary tophus size as determined by physical measurement was calculated as [(Week 52 - baseline sizes)/baseline]*100 for the subset of subjects with a primary palpable tophus at the Screening Visit. If the primary tophus was no longer palpable at the Week 52 visit, the size was assumed to be zero.|Baseline and Week 52|Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug, had a baseline serum urate ≥8.0 mg/dL, and had a palpable primary tophus measured at baseline. Missing data were not imputed.||percent change from baseline||Inter-Quartile Range|Median
705040|NCT00105989|Secondary|Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of the Participants -- Open-Label Continuation Phase||Every Visit from Week 10 up to Week 34 (Continuation)|Treatment-Emergent Adverse Events (TEAE) occurring in at least 5% of patients. Intent to Treat analysis.||participants|||Number
704930|NCT00102440|Secondary|Percent Change From Baseline in Tophus Size at Week 28, as Determined by Physical Measurement, in Subjects With a Palpable Primary Tophus at Screening.|The percent change from baseline in primary tophus size as determined by physical measurement was calculated as [(Week 28 - baseline sizes)/baseline]*100 for the subset of subjects with a primary palpable tophus at the Screening Visit. If the primary tophus was no longer palpable at the Week 28 visit, the size was assumed to be zero.|Baseline and Week 28|Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug, had a baseline serum urate ≥8.0 mg/dL, and had a palpable primary tophus measured at baseline. Missing data were not imputed.||percent change from baseline||Inter-Quartile Range|Median
704931|NCT00102440|Secondary|Percent Change From Baseline in Serum Urate Levels at Final Visit|The percent change in serum urate from baseline to the Final visit was calculated as [(Final Visit - baseline levels/baseline)]*100 and summarized. The Final visit was the last visit with a serum urate value. The timing of the final visit may have differed for each subject.|Baseline and Final Visit (up to 52 weeks)|Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL. Missing data were not imputed.||percent change from baseline||Standard Deviation|Mean
704932|NCT00102440|Secondary|Percent Change From Baseline in Serum Urate Levels at Week 52.|Serum urate values were obtained at the Week 52 visit. The percent change in serum urate was calculated as [(week 52 - baseline levels/baseline)]*100 and summarized.|Baseline and Week 52|Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL. Missing data were not imputed.||percent change from baseline||Standard Deviation|Mean
704933|NCT00102440|Secondary|Percent Change From Baseline in Serum Urate Levels at Week 28.|Serum urate values were obtained at the Week 28 visit. The percent change in serum urate was calculated as [(week 28 - baseline levels/baseline)]*100 and summarized.|Baseline and Week 28|Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL. Missing data were not imputed.||percent change from baseline||Standard Deviation|Mean
704934|NCT00102440|Secondary|Percentage of Subjects With Serum Urate <6.0 mg/dL at Final Visit|The percentage of subjects whose serum urate was <6.0 mg/dL at the final visit was summarized. The final visit was the last visit at which a serum urate value was collected. The timing of the final visit may have differed for each subject.|Final Visit (up to 52 weeks)|Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL. Missing data were not imputed.||Percentage of subjects|||Number
704935|NCT00102440|Secondary|Percentage of Subjects With Serum Urate <6.0 mg/dL at Week 52 Visit|Serum urate values were obtained at the Week 52 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Week 52 visit was summarized.|Week 52|Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL. Missing data were not imputed.||Percentage of subjects|||Number
704936|NCT00102440|Secondary|Percentage of Subjects With Serum Urate <6.0 mg/dL at Week 28 Visit|Serum urate values were obtained at the Week 28 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Week 28 visit was summarized.|Week 28|Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL. Missing data were not imputed.||Percentage of subjects|||Number
704937|NCT00102440|Primary|Percentage of Subjects With the Last 3 Serum Urate Levels <6.0 Milligrams Per Deciliter (mg/dL)|Each subject’s serum urate at the last 3 visits determined the subject’s response for the primary efficacy variable. A subject who prematurely discontinued without least 3 postbaseline serum urate levels was considered a nonresponder; if at least 3 serum urate were obtained postbaseline, those 3 visits were used. The last 3 visits used may have differed for each subject.|Last 3 Visits (up to 52 weeks)|Analysis was performed on the intent-to-treat (ITT) subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL.||Percentage of subjects|||Number
704938|NCT00102518|Secondary|Change in Young Mania Rating Scale (Y-MRS) Total Score|"Change from baseline to last scheduled post-baseline evaluation in YMRS total score, using observed cases (assessments performed at baseline and weeks 4, 12, and 26).
The Y-MRS consists of 11 items assessing the core symptoms of mania. Each item has 5 grades of severity. Minimum score on the scale is 0 (absent or normal). Maximum score on the scale is 60 (worse outcome or more severe symptoms)."|Baseline and Week 26|||points||Standard Deviation|Mean
704939|NCT00102518|Secondary|Change in Change in Positive and Negative Syndrome Scale (PANSS) Total Score|"Change from baseline to the last scheduled post-baseline evaluation in PANSS total score, using observed cases (assessments performed at baseline and weeks 4, 12, and 26).
This scale consists of symptom constructs (7 positive, 7 negative, 16 general psychopathology), each to be rated on a 7-point scale of severity with 1 being absent to 7 being extreme. Minimum score is 30 which is best outcome; maximum score is 210 for worse outcome."|Baseline and Week 26|||points||Standard Deviation|Mean
704940|NCT00102518|Primary|Percentage of Subjects Experiencing SAEs|Percentage of Subjects Experiencing SAEs. The incidences of SAEs are summarized by system organ class in CT-8.5.1; by system organ class and MedDRA preferred term and by system organ class, MedDRA preferred term, and severity.|Baseline and Week 23|All enrolled subjects.||percentage of participants|||Number
704941|NCT00102531|Primary|The Study Medication Was to be Considered Effective if the Population Response Rate Was Found to be Greater Than 20% and Individuals Who Demonstrated a CR or PR or Whose Tumours Demonstrated a Grade 3 or 4 Histologic Response at the Time of Surgery.||4 to 48 weeks|||participants|||Number
704942|NCT00102596|Secondary|PR and QTc Intervals Post 1-Octanol Dose||0 minutes, 15 minutes, 100 minutes and 24 hours post-dose|All participants who received at least 1 dose of 1-octanol in Part A, B or C||ms||Standard Error|Least Squares Mean
704943|NCT00102596|Secondary|Heart Rate Post 1-Octanol Dose||0 minutes, 15 minutes, 100 minutes and 24 hours post-dose|All participants who received at least 1 dose of 1-octanol in Part A, B or C||beats per minute||Standard Error|Least Squares Mean
705041|NCT00105989|Secondary|Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of Participants -- Open-Label Acute Therapy Phase||Every Visit from Week 0 up to Week 10 (Acute)|Treatment-Emergent Adverse Events (TEAE) occurring in at least 5% of patients. Intent to Treat analysis.||participants|||Number
704945|NCT00102596|Primary|Normalized Mean Tremor Amplitude for Both Formulations of 64 mg/kg 1-Octanol in Part B|Spirography mean tremor amplitudes were measured in the right hand of each participant at 0, 15, 30, 60, 90, 120, 150, 180, 240 and 360 minutes post-dose. Then, the scores of each participant were normalized (i.e., divided by) by their baseline tremor severity scores so that all scores are expressed as a proportion of the baseline score. Therefore, 1 is the baseline tremor severity, and lower scores indicate tremor reduction.|0, 15, 30, 60, 90, 120, 150, 180, 240 and 360 minutes post-dose|All participants who received both formulations of 64 mg/kg 1-octanol in Part B||normalized score on a scale||Standard Error|Mean
704946|NCT00102687|Secondary|Change From Baseline in the Number of Infections Requiring Treatment With IV Antibiotics Per Treatment Cycle (28 Days) for the Maintenance Study Period|Baseline uses the average number of infections requiring IV antibiotic treatment from the 28 days prior to and including the day of first dose to an initial treatment arm. Maintenance study period values total the number of infections requiring IV antibiotic treatment divided by the number of treatment cycles (each cycle is approximately one month).|24 months|Intent to treat population||infections per cycle||Full Range|Median
704947|NCT00102687|Secondary|Change From Baseline in the Number of Infections Requiring Treatment With IV Antibiotics Per Treatment Cycle (28 Days) for the Initial Study Period|Baseline uses the average number of infections requiring IV antibiotic treatment from the 28 days prior to and including the day of first dose to an initial treatment arm. Initial study period values total the number of infections requiring IV antibiotic treatment divided by the number of treatment cycles (each cycle is approximately one month).|6 months|Intent to treat population||infections per cycle||Full Range|Median
704948|NCT00102687|Secondary|Platelet Transfusion Status at Baseline and End of Maintenance Study Period (24 Months)|Shift table comparing the platelet transfusion status of patients at the end of the maintenance study period to the transfusion status at baseline.|24 months|Intent to treat population||participants|||Number
704949|NCT00102687|Secondary|Red Blood Cell (RBC) Transfusion Status at Baseline and End of Maintenance Study Period (24 Months)|Shift table comparing the RBC transfusion status of patients at the end of the maintenance study period to the transfusion status at baseline.|24 months|Intent to treat population||participants|||Number
704950|NCT00102687|Secondary|Platelet Transfusion Status at Baseline and End of Initial Study Period (6 Months)|Shift table comparing the platelet transfusion status of patients at the end of the initial study period to the transfusion status at baseline.|6 months|Intent to treat population||participants|||Number
704951|NCT00102687|Secondary|Red Blood Cell (RBC) Transfusion Status at Baseline and End of Initial Study Period (6 Months)|Shift table comparing the RBC transfusion status of patients at the end of the initial study period to the transfusion status at baseline.|6 months|Intent to treat population||participants|||Number
704952|NCT00102687|Secondary|Change From Baseline in Absolute Neutrophil Count (ANC) at the End of the Maintenance Study Period (Month 24)|The difference between ANC values at the end of the maintenance study period minus the ANC values at baseline.|24 months|Intent to treat population||x10^9/L||Full Range|Median
704953|NCT00102687|Secondary|Change From Baseline in Absolute Neutrophil Count (ANC) at the End of Initial Study Period (6 Months)|The difference between ANC values at the end of the initial study period minus the ANC values at baseline.|6 months|Intent to treat population||x10^9/L||Full Range|Median
704954|NCT00102687|Secondary|Baseline Absolute Neutrophil Count (ANC) Values|The median values for ANC based on blood tests performed on study day 1 (prior to study treatment) constitute a baseline measure for ANC. Baseline values are used to compare to values following treatment.|Day 1 (randomization)|Intent to treat population||x10^9/L||Full Range|Median
704955|NCT00102687|Secondary|Change From Baseline in Platelets at the End of the Maintenance Study Period (Month 24)|The difference between platelet values at the end of the maintenance study period minus the platelet values at baseline.|24 months|Intent to treat population||x10^9/L||Full Range|Median
704956|NCT00102687|Secondary|Change From Baseline in Platelets at the End of Initial Study Period (6 Months)|The difference between platelet values at the end of the initial study period minus the platelet values at baseline.|6 months|Intent to treat population||x10^9/L||Full Range|Median
704957|NCT00102687|Secondary|Baseline Platelet Values|The median values for platelets based on blood tests performed on study day 1 (prior to study treatment) constitute a baseline measure for platelets. Baseline values are used to compare to values following treatment.|Day 1 (randomization)|Intent to treat population||x10(9)/L||Full Range|Median
704958|NCT00102687|Secondary|Change From Baseline in Hemoglobin at the End of the Maintenance Study Period|The difference between hemoglobin values at the end of the maintenance study period minus the hemoglobin values at baseline.|24 months|Intent to treat population||g/L||Full Range|Median
704959|NCT00102687|Primary|Number of Participants Who Improved or Maintained The Hematologic Response From the Initial Study Period (Based on IWG 2000 Criteria For MDS) During the Maintenance Period|Hematologic response during the maintenance period are compared to the response in the initial study period. Initial response could have been a complete remission, a partial remission, stable disease or a hematologic improvement. Maintenance period best response is after randomization to a maintenance arm for those randomized, and is after the start of cycle 7 for those remaining on initial period treatment throughout the study.|24 months|Intent to treat population.||participants|||Number
704960|NCT00102687|Secondary|Change From Baseline in Hemoglobin at End of Initial Study Period (6 Months)|The difference between hemoglobin values at the end of the initial study period minus the hemoglobin values at baseline.|6 months|Intent to treat population||g/L||Full Range|Median
704961|NCT00102687|Secondary|Baseline Hemoglobin Values|The median values for hemoglobin based on blood tests performed on study day 1 (prior to study treatment) constitute a baseline measure for hemoglobin. Baseline values are used to compare to values following treatment.|Day 1 (randomization)|Intent to treat population||g/L||Full Range|Median
704962|NCT00102687|Primary|Number of Participants With Overall Best Hematologic Response and Hematologic Improvement Based on IWG 2000 Criteria For MDS During the Initial Study Period|Number of participants whose best hematological outcome was either complete remission (CR), partial remission (PR) (as determined by the investigator), or any hematologic improvement (based on the IWG 2000 criteria for MDS). See previous outcomes for detailed definitions.|Day 1 (randomization) to 6 months|Intent to treat population||participants|||Number
731770|NCT00399542|Secondary|Month 2 Abdominal Bloating Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|28 days|ITT with LOCF||units on a scale||Standard Deviation|Mean
704963|NCT00102687|Primary|Number of Participants With Best Hematological Improvement Derived Using International Working Group 2000 (IWG 2000) Criteria for MDS During the Initial Study Period.|"IWG 2000 Criteria: Pretreatment=hemoglobin <110g/L or RBC transfusion-dependence, platelet count <100x10^9/L or platelet transfusion dependence, absolute neutrophil count <1.5x10^9/L.
Erythroid response: Major->20g/L increase in hemoglobin or transfusion independence. Minor- 10-20g/L increase in hemoglobin or >=50% decrease in transfusion requirements.
Platelet response: Major-absolute increase of platelet count by >=30x10^9/L or platelet transfusion independence. Minor->=50% increase in platelet count with net increase >10x10^9/L but <30x10^9/L.
(continued in Population Description)"|Day 1 (randomization) to 6 months|"Intent to treat population. Patients count only once for best response within an improvement category.
(Outcome Description continued) Neutrophil response: Major->=100% increase in neutrophil count or an absolute increase of >0.5x10^9/L. Minor->=100% increase but an absolute increase of <0.5x10^9/L."||participants|||Number
704964|NCT00102687|Primary|Number of Participants In Best Hematological Response Categories as Determined by the Investigator Using International Working Group 2000 (IWG 2000) Criteria For Myelodysplastic Syndromes (MDS) During the Initial Study Period.|"Participant counts by best hematological response; complete remission(CR) is better than a partial remission(PR) which is better than stable disease(SD).
Investigator determined responses followed IWG 2000 criteria for MDS CR: repeat bone marrow show <5% myeloblasts, and peripheral blood evaluations lasting >=2 months of hemoglobin(>110 g/L), neutrophils(>=1.5x10^9/L), platelets(>=100x10^9/L), blasts (0%) and no dysplasia PR is the same as CR for peripheral blood: bone marrow shows blasts decrease by >=50% or a less advanced FAB classification from pretreatment (see Population Descrip)"|Day 1 (randomization) to 6 months|"Intent to treat population. Patients without a second bone marrow assessment could not be evaluated for hematologic response.
(Outcome Description continued)SD is a failure to achieve at least a PR, but with no evidence of progression for at least 2 months."||participants|||Number
704965|NCT00102804|Secondary|Maximum Improvement Over Baseline in Individual Symptom Scores and Quality of Life Using the LCSS|The participant-reported LCSS was a 9-item questionnaire. Six items were symptom-specific measures for lung cancer (loss of appetite, fatigue, cough, dyspnea, hemoptysis, and pain), and 3 summation items described total symptomatic distress, interference with activity level, and global quality of life. Participant responses to each item were measured using VAS from 0 (for best outcome) to 100 (for worst outcome). The average symptom burden index (ASBI) was the mean of the 6 symptom-specific items. The LCSS total score was the mean of the 9 items.|Baseline through 30 days post discontinuation of study treatment (up to 39 Months)|Participants who signed the ICF, completed the randomization process, had LCSS data at baseline and at least once postdose are reported according to the treatment arm to which they were randomized.||units on a scale||Standard Deviation|Mean
704966|NCT00102804|Secondary|Number of Participants With Adverse Events (AEs)|Clinically significant events were defined as serious adverse events (SAEs) and other non-serious AEs regardless of causality. A summary of serious and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.|Baseline to study completion (up to 41 Months)|Participants who signed the ICF, completed the randomized process and received at least 1 dose of study drug are reported according to the treatment to which they were received.||participants|||Number
704967|NCT00102804|Secondary|Percentage of Participants With a Complete Response (CR) or Partial Response (PR) (Objective Tumor Response Rate)|Response was defined using RECIST v1.0 criteria. CR was defined as the disappearance of all target lesions. PR was defined either A) at least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LDs or B) complete disappearance of target lesions, with persistence (but not worsening) of 1 or more nontarget lesions. In either case, no new lesions may have appeared. The percentage of participants with CR or PR=(Number of participants with CR or PR)/(Number of participants assessed)*100.|Baseline to measured PD (up to 41 months)|Participants who signed the ICF and completed the randomized process are reported according to the treatment arm to which they were randomized.||percentage of participants||95% Confidence Interval|Number
704968|NCT00102804|Secondary|Time to Worsening of Symptoms (TWS)|TWS was the elapsed time from the date of randomization to the first date of worsening [defined as a 15-millimeter (mm) increase from baseline based on a 100-mm scale] of each symptom and summary item in the Lung Cancer Symptom Scale (LCSS). The participant-reported LCSS was a 9-item questionnaire. Six items were symptom-specific measures for lung cancer (loss of appetite, fatigue, cough, dyspnea, hemoptysis, and pain), and 3 summation items described total symptomatic distress, interference with activity level, and global quality of life. Participant (pt) responses to each item were measured using visual analogue scales (VAS) from 0 (for best outcome) to 100 (for worst outcome). TWS was censored at the date of the last LCSS assessment for pts who were not known to have LCSS worsening.|Randomization to worsening of each LCSS item (up to 39 months)|Pts who signed ICF and completed randomization, according to treatment randomized. Pts censored: Loss of appetite 236,140; fatigue 237,130; cough 274,146; dyspnea 271,143, hemoptysis 404,198; pain 271,135; symptom distress 247,141; interference with activity level 267,141, global quality of life 262,137 pts in pemetrexed, placebo arm, respectively.||months||95% Confidence Interval|Median
704969|NCT00102804|Secondary|Time to Objective Progressive Disease (TPD)|TPD was the elapsed time from the date of randomization to the first date of objective PD. TPD was censored at the date of the participant’s last tumor assessment for participants who were not known to have PD as of the data-inclusion cut-off date for analysis or who died without objective PD. PD, defined using RECIST v1.0, was at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.|Randomization to measured PD (up to 41 months)|Participants who signed the ICF and completed the randomized process are reported according to the treatment arm to which they were randomized. Participants censored: N = 145, 40 participants in the pemetrexed and placebo treatment arms, respectively.||months||95% Confidence Interval|Median
704970|NCT00102804|Secondary|Overall Survival (OS) Time|OS time was the elapsed time from the date of randomization to the date of death from any cause. OS was censored at the last date of contact for participants who were not known to have died as of the data-inclusion cut-off date for analysis.|Randomization to date of death from any cause (up to 41 months)|Participants who signed the ICF and completed the randomized process are reported according to the treatment arm to which they were randomized. Participants censored: N = 138, 48 participants in the pemetrexed and placebo treatment arms, respectively.||months||95% Confidence Interval|Median
704971|NCT00102804|Primary|Progression-Free Survival (PFS) Time|PFS time was the elapsed time from the date of randomization to the first date of objective progression of disease or death from any cause. PFS was censored at the date of the participant’s last tumor assessment for participants who were not known to have died or to have PD as of the data-inclusion cut-off date for analysis. PD, defined using Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0), was at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.|Randomization to measured PD or death from any cause (up to 41 months)|Participants who signed the ICF and completed the randomized process are reported according to the treatment arm to which they were randomized. Participants censored: N = 123, 36 participants in the pemetrexed and placebo treatment arms, respectively.||months||95% Confidence Interval|Median
704972|NCT00103012|Primary|Lopinavir Pharmacokinetics When Administered Alone and in Combination With Three Different Herbal Supplements: Ginkgo Biloba, Panax Ginsing, and Echinacea Purpurea.|The outcome measurement for each study arm is the change in lopinavir area under the concentration versus time curve (AUC) after two weeks administration of an herbal preparation (Ginkgo Biloba, Echinacea purpurea, or Panax Ginseng).|2 weeks|Data was analyzed from all subjects who completed a particular sampling period.||mcg*hr/mL||90% Confidence Interval|Geometric Mean
704973|NCT00103116|Secondary|Number of Participants Alive Five Years Post Vaccine|Documentation of radiographic surveillance for recurrence or progression for 5 years post-vaccine|five years post vaccine|||participants|||Number
704974|NCT00103116|Primary|Number of Participants Showing Immunologic Response to Vaccine Within Six Months of Immunization|Antigen specific reaction is measured serially in blood of each participant prior to and through six months post-vaccine. Increase in levels of specific T cell activity from pre vaccine to post vaccine serve as primary measures of an individual's response to vaccine. The number (relative percent) of participants achieving immunologic response to vaccine within 6 month of immunization was the dominant metric of vaccine activity within the study population.|six months post vaccine|||participants with immunological response|||Number
704975|NCT00103142|Secondary|Positive Immune Response as Measured by (Enzyme-linked Immunosorbent Spot) ELISpot Assay|CEA-Specific Immune Responders by enzyme-linked immunosorbent spot (ELISpot). The ELISPOT assay is considered positive for a subject if the mean number of spots with CEA exceeds the number of spots with control by a magnitude of 10 and the difference between CEA and control is statistically significant at a level of p=0.05 by the t-test.|13 weeks|||participants|||Number
704976|NCT00103142|Primary|Recurrence-free Survival at 2 Years|Recurrence-free survival for randomized patients receiving dendritic cells (DC) loaded with PANVAC or PANVAC plus Granulocyte-macrophage colony-stimulating factor (GM-CSF) measured from the date of metastasectomy, with relapse defined as documented disease recurrence at any site.|2 years|||participants|||Number
704977|NCT00103194|Secondary|Relationship Between Progression-free Survival and EGFR Expression Levels|The association between EGFR (epidermal growth factor receptor) expression levels and the length of time during and after treatment in which a patient is living with a disease that does not get worse.|Assessed every cycle while on treatment; after being off-treatment, assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years|Eligible patients who started treatment.||months||90% Confidence Interval|Median
704978|NCT00103194|Secondary|Progression-free Survival Rate at 2 Years|Proportion of patients who are living with a disease that does not get worse at 2 years from registration based on Kaplan-Meier method.|Assessed every cycle while on treatment; after being off-treatment, assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years|Eligible patients who started treatment.||percentage of participants||90% Confidence Interval|Number
704979|NCT00103194|Secondary|The Change in PSA Slope With GW572016 (Lapatinib)|PSA was evaluated every cycle while on treatment. PSA test results show the level of PSA detected in the blood. These results were reported as nanograms of PSA per milliliter (ng/mL) of blood. PSA slope is the change in PSA level over time. A sharp rise in the PSA level raises the suspicion of cancer and may indicate a fast-growing cancer.|Assessed every cycle while on treatment; after being off-treatment, assessed every 3 months for 2 years, then every 6 months for 3 years, then annually, for 5 years|One patient who withdrew from study after receiving 4 days of treatment and did not have any follow-up PSA measurements was excluded from this analysis, so the number of participants analyzed is 34.||log (PSA)/month||Standard Error|Mean
704980|NCT00103194|Primary|Number of Patients With PSA Response, Defined as a 50% or Greater Decline in the Serum PSA Level|"PSA response is defined as either complete response (CR) or partial response (PR) observed at any time during the entire measurement time period.
CR: In patients treated with prior radical prostatectomy, a PSA < 0.2 ng/mL confirmed by a repeat PSA at least one month apart was considered a complete biochemical response. In patients treated with radiation therapy only, a PSA < 1 ng/mL on three separate occasions taken at least one month apart was considered a complete biochemical response.
PR: A reduction in PSA by > 50% from baseline, confirmed by repeat PSA 1 month later."|Assessed every cycle while on treatment; after being off-treatment, assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years|Eligible patients who started protocol treatment||participants|||Number
704981|NCT00091572|Secondary|Duration of Objective Response|Duration of objective response was measured from the time the criteria were met for complete response or partial response to the first date that recurrent or progressive disease was objectively documented.|Treatment continued until disease progression or unacceptable toxicity.|All responders||Months||95% Confidence Interval|Median
704982|NCT00091572|Secondary|Objective Response Rate in Subjects With Measurable Lesions|Based on investigator's assessment of response in subjects with measurable lesions. Objective response = complete response + partial response. Complete response = disappearance of all target lesions. Partial response = at least a 30% decrease in the sum of longest diameter of target lesions taking as reference the baseline sum longest diameter.|Treatment continued until disease progression or unacceptable toxicity.|Intent to treat population with measurable disease at Baseline.||Ratio||95% Confidence Interval|Median
704983|NCT00091572|Primary|Overall Survival|Overall Survival was defined as the time from the date of randomization to the date of death from any cause.|The final analysis was to be performed when at least 616 deaths had occurred.|Intent to Treat Population||Months||95% Confidence Interval|Median
731771|NCT00399542|Secondary|Month 1 Abdominal Bloating Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|28 days|ITT with LOCF||units on a scale||Standard Deviation|Mean
704984|NCT00091572|Secondary|Progression Free Survival|Progression free survival was defined as the time from the date of randomization to the date of disease progression or the date of death regardless of the cause.|Treatment continued until disease progression or unacceptable toxicity. Patients will be followed for survival.|Intent to Treat Population||Months||95% Confidence Interval|Median
704985|NCT00091793|Secondary|Distal Radius Total Volumetric Bone Mineral Density Percent Change From Baseline at Month 24|Volumetric Bone Mineral Density Assessed by Quantitative Computerized Tomography (QCT).|24 months|||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
704986|NCT00091793|Secondary|Distal Radius Cortical Volumetric Bone Mineral Density Percent Change From Baseline at Month 24|Volumetric Bone Mineral Density Assessed by Quantitative Computerized Tomography (QCT).|24 months|||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
704987|NCT00091793|Secondary|Distal Radius Trabecular Volumetric Bone Mineral Density Percent Change From Baseline at Month 24|Volumetric Bone Mineral Density Assessed by Quantitative Computerized Tomography (QCT).|24 months|||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
704988|NCT00091793|Secondary|Total Body (Without Head) Bone Mineral Density Percent Change From Baseline at Month 24|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|24 months|||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
704989|NCT00091793|Secondary|Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 24|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|24 months|||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
704990|NCT00091793|Secondary|Trochanter Bone Mineral Density Percent Change From Baseline at Month 24|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|24 months|||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
704991|NCT00091793|Secondary|Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 24|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|24 Months|||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
704992|NCT00091793|Secondary|Total Hip Bone Mineral Density Percent Change From Baseline at Month 24|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|24 Months|||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
704993|NCT00091793|Primary|Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|24 Months|Randomized subjects who have a non-missing baseline and at least 1 non-missing postbaseline evaluation at or prior to month 24. LOCF was used as imputation method.||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
704994|NCT00091819|Primary|Clinical Response|The Clinical Response for each patient was determined by the investigator by assessing a patient's clinical signs and symptoms at the specified evaluation compared with the Baseline evaluation. Cure: resolution of signs and symptoms associated with the skin infection present at study admission such that no further antibiotic therapy was necessary; Not Cured: inadequate response to study therapy; Indeterminate: unable to determine outcome.|7-14 days following end of antibiotic treatment|Data for the all-treated (AT) population are presented. the AT and clinically evaluable (CE) populations were considered co-primary.||participants|||Number
704995|NCT00091832|Secondary|Number of Participants With Hypercalcemia|Occurrence of grade 3 or 4 hypercalcemia according to the Common Terminology Criteria for Adverse Events (CTCAE) v3. A summary of hypercalcemia events is reported under adverse events.|Day 1 to Week 57|Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).||Participants|||Number
704996|NCT00091832|Secondary|Number of Participants With Skeletal Related Events|Skeletal Related Events (SRE) are defined as ≥ 1 of the following: pathological bone fracture, spinal cord compression, surgery or radiation therapy to bone (including the use of radioisotopes).|From Day 1 to Week 25|All participants who were exposed to investigational product.||Participants|||Number
704997|NCT00091832|Secondary|Time to First Skeletal Related Event|Skeletal Related Event (SRE) defined as ≥ 1 of the following: pathological bone fracture, spinal cord compression, surgery or radiation therapy to bone (including the use of radioisotopes).|Day 1 to Week 25|All participants who were exposed to investigational product.||Days||95% Confidence Interval|Median
704998|NCT00091832|Secondary|Percent Change From Baseline to Week 25 in Osteocalcin|Percent change from Baseline to Week 25 in osteocalcin calculated using ((Week 25 value - Baseline value) / Baseline value) x 100.|Baseline and Week 25|Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).||Percent change||Standard Deviation|Mean
704999|NCT00091832|Secondary|Percent Change From Baseline to Week 13 in Osteocalcin|Percent change from Baseline to Week 13 in osteocalcin calculated using ((Week 13 value - Baseline value) / Baseline value ) x 100.|Baseline and Week 13|Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).||Percent change||Standard Deviation|Mean
705000|NCT00091832|Secondary|Percent Change From Baseline to Week 25 in Bone Specific Alkaline Phosphatase (BSAP)|Percent change from Baseline to Week 25 in BSAP calculated using ((Week 25 value - Baseline value) / Baseline value) x 100.|Baseline and Week 25|Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).||Percent change||Standard Deviation|Mean
705001|NCT00091832|Secondary|Percent Change From Baseline to Week 13 in Bone Specific Alkaline Phosphatase (BSAP)|Percent change from Baseline to Week 13 in bone specific alkaline phosphatase (BSAP) calculated using ((Week 13 value - Baseline value) / Baseline value) x 100.|Baseline and Week 13|Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).||Percent change||Standard Deviation|Mean
705002|NCT00091832|Secondary|Percent Change From Baseline to Week 25 in Tartrate-resistant Acid Phosphatase 5b (TRAP5b)|Percent change from Baseline to Week 25 in TRAP5b calculated using ((Week 25 value - Baseline value) / Baseline value) x 100.|Baseline and Week 25|Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).||Percent change||Standard Deviation|Mean
705003|NCT00091832|Secondary|Percent Change From Baseline to Week 13 in Tartrate-resistant Acid Phosphatase 5b (TRAP5b)|Percent change from Baseline to Week 13 in tartrate-resistant acid phosphatase 5b calculated using ((Week 13 value - Baseline value) / Baseline value) x 100.|Baseline and Week 13|Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).||Percent change||Standard Deviation|Mean
705004|NCT00091832|Secondary|Percent Change From Baseline to Week 25 in P1NP|Percent change from Baseline to Week 25 in procollagen 1 N-terminal peptide (P1NP) calculated using ((Week 25 value - Baseline value) / Baseline value ) x 100.|Baseline and Week 25|Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).||Percent change||Standard Deviation|Mean
705005|NCT00091832|Secondary|Percent Change From Baseline to Week 13 in Procollagen I N-terminal Peptide (P1NP)|Percent change from Baseline to Week 13 in procollagen 1 N-terminal peptide calculated using ((Week 13 value - Baseline value) / Baseline value) x 100.|Baseline and Week 13|Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).||Percent change||Standard Deviation|Mean
705006|NCT00091832|Secondary|Percent Change From Baseline to Week 25 in Serum C-telopeptide (CTX)|Percent change from Baseline to Week 25 in type I serum C-telopeptide calculated using ((Week 25 value - Baseline value) / Baseline value) x 100.|Baseline and Week 25|Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).||Percent change||Standard Deviation|Mean
705007|NCT00091832|Secondary|Percent Change From Baseline to Week 13 in Serum C-Telopeptide (CTX)|Percent change from Baseline to Week 13 in type I serum C-telopeptide (CTX) calculated using ((Week 13 value - Baseline value) / Baseline value) x 100.|Baseline and week 13|Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).||Percent change||Standard Deviation|Mean
705008|NCT00091832|Secondary|Time to 65% or More Reduction in Urinary N-telopeptide (uNTX) From Baseline|Kaplan-Meier estimate of the median time from enrollment to the first occurrence of a reduction of uNTx of ≥ 65% compared to Baseline. For participants whose uNTx did not fall below 65% of the Baseline value, the time was censored at time of last evaluation of uNTx.|Baseline to Week 57|Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).||Days||Inter-Quartile Range|Median
705009|NCT00091832|Secondary|Number of Participants Achieving 65% or More Reduction in uNTX From Baseline at Week 25|The number of participants achieving a 65% reduction or more in uNTX from Baseline at Week 25. Calculation used is ((Week 25 value - Baseline value) / Baseline value) x 100 and participants were considered having a 65% reduction or more if their value was ≤ -65%.|Baseline and Week 25|Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).||Participants|||Number
705010|NCT00091832|Secondary|Number of Participants Achieving 65% or More Reduction in Urinary N-telopeptide (uNTx) From Baseline at Week 13|The number of participants achieving a 65% reduction or more in uNTx from Baseline at Week 13. Calculation used is ((Week 13 value - Baseline value) / Baseline value ) x 100 and participants were considered having a 65% reduction or more if their value was ≤ -65%.|Baseline and Week 13|Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a Baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).||Participants|||Number
705011|NCT00091832|Secondary|Percent Change From Baseline to Week 25 in Urinary N-telopeptide (uNTx)|Percent change from Baseline to Week 25 in Urinary N-telopeptide (uNTx) calculated using ((Week 25 value - Baseline value) / Baseline value) x 100.|Baseline and Week 25|Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).||Percent change||Standard Deviation|Mean
705012|NCT00091832|Primary|Percent Change From Baseline to Week 13 in Creatinine-adjusted Urinary N-telopeptide (uNTx/Cr)|Percent change from Baseline to Week 13 in Urinary N-telopeptide corrected by creatinine (uNTx/Cr) calculated using ((Week 13 value - Baseline value) / Baseline value ) x 100.|Baseline and Week 13|Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).||Percent change||Standard Deviation|Mean
705013|NCT00103207|Secondary|Time to Progression by Smoking Status|Medians of time to progression by smoking status are reported.|Progression assessed every 8 weeks during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years. Smoking status evaluated at baseline|Only eligible and treated patients with confirmed diagnosis and smoking status data are included in the analysis.||Months||95% Confidence Interval|Median
705014|NCT00103207|Secondary|Overall Survival by Smoking Status|Medians of overall survival by smoking status are reported.|Overall survival assessed every week during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years. Smoking status evaluated at baseline|Only eligible and treated patients with confirmed diagnosis and smoking status data are included in the analysis.||Months||95% Confidence Interval|Median
705015|NCT00103207|Secondary|Time to Progression|Time to progression is defined as time from study entry until disease progression. Progression is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s) or unequivocal progression of existing nontarget lesions.|Assessed every 8 weeks during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years|Only eligible and treated patients with confirmed diagnosis are included in the analysis.||Months||95% Confidence Interval|Median
705016|NCT00103207|Secondary|Overall Survival|Overall survival is defined as the time from registration to death.|Every week during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years|Only eligible and treated patients with confirmed diagnosis are included.||Months||95% Confidence Interval|Median
705017|NCT00103207|Primary|Objective Response Rate (Proportion of Patients With Objective Response)|Response was evaluated using RECIST 1.0 criteria. Per RECIST criteria, Complete response (CR)= disappearance of all target and nontarget lesions Partial response (PR)= >=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits. Objective response = CR + PR.|Assessed every 8 weeks during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years|Only eligible and treated patients with confirmed diagnosis are included in this analysis.||Proportion||90% Confidence Interval|Number
705018|NCT00103259|Secondary|Overall Survival on Step 1|Overall survival was defined as time from registration on step 1 to death from any cause. It was evaluated in all 61 eligible and treated patients.|Survival was assessed every 3 month within 2 years and every 6 months betwen 2 and 3 years|61 eligible and treated patients were included in the analysis||months||95% Confidence Interval|Median
705019|NCT00103259|Secondary|Progression-free Survival on Step 1|Progression-free survival was defined as time from registration to step 1 to disease recurrence or death from any cause, whichever occurred first. Disease progression was measured by Response Evaluation Criteria In Solid Tumors (RECIST) v1.0, and defined as at least a 20% increase in the sum of the longest diameters of target lesions.|Every 3 months for first 2 years from protocol entry, then every 6 months until 3 years from study entry|61 eligible and treated patients were included in the analysis||months||95% Confidence Interval|Median
705020|NCT00103259|Secondary|Response Rate on Step 2|Tumor response was evaluated via Response Evaluation Criteria In Solid Tumors (RECIST) v1.0, and response rate was defined as the proportion of patients with a complete response or partial response among all eligible and treated patients. Complete response was defined as disappearance of all tumor lesions. Partial response was defined as at least a 30% decrease in the sum of the longest diameters of target lesions.|Tumor response was assessed after every 2 cycles until progression or intolerable toxicity with maximum of 3 years|10 eligible and treated patients who progressed on bortezomib and crossed over to bortezomib and irinotecan arm were included in the analysis||percentage of participants||90% Confidence Interval|Number
705021|NCT00103259|Primary|Response Rate on Step 1|Tumor response was evaluated via Response Evaluation Criteria In Solid Tumors (RECIST) v1.0, and response rate was defined as the proportion of patients with a complete response or partial response among all eligible and treated patients. Complete response was defined as disappearance of all tumor lesions. Partial response was defined as at least a 30% decrease in the sum of the longest diameters of target lesions.|Tumor response was assessed every 2 cycles until progression or intolerable toxicity with maximum of 3 years|61 eligible and treated patients were included in the analysis||percentage of participants||90% Confidence Interval|Number
705022|NCT00103311|Secondary|Overall Survival|Will be estimated using the product-limit method of Kaplan and Meier by arm.|From the date of registration to the date of death, assessed up to 12 months|||months||95% Confidence Interval|Median
705023|NCT00103311|Secondary|Progression-free Survival|Will be estimated using the product-limit method of Kaplan and Meier by arm. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|From the date of registration to the date of documented PSA progression, assessed up to 6 months|||weeks||95% Confidence Interval|Median
705024|NCT00103311|Primary|Objective Response (CR or PR) as Determined by the RECIST Criteria|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Up to 5 years|||participants|||Number
705025|NCT00103506|Secondary|Number of Participants With Serious Adverse Events (SAEs)|A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Up to 1 year and 11 months (From date of first participant randomization [20 December 2004] to cut-off date for safety update (28 November 2006)|Safety population included all the participants who received at least one dose of study drug. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||Participants|||Number
705026|NCT00103506|Secondary|Overall Survival|The OS is defined as the time from the date of first dose of study drug to date of death from any cause. If the participant is alive or the vital status is unknown, the participant will be censored at the date the participant will be last known to be alive.|Up to 9 years and 5 months (From date of first participant randomization [20 December 2004] to cut-off date for final survival analysis (16 May 2014)|||months||95% Confidence Interval|Median
705042|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Glucose - Maintenance Phase||Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.||millimoles per Liter||Standard Deviation|Mean
705027|NCT00103506|Primary|Time to Progression (TTP)|Median time to progression of disease is assessed according to International Myeloma Working Group (IMWG) criteria or death from any cause. IMWG criteria: increase of >=25% from lowest level in Serum M-component or (the absolute increase must be >=0.5 gram per deciliter [g/dL]); Urine M component or (the absolute increase must be >=200 milligram per 24 hour. Only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain levels. The absolute increase >10 mg/dL. Bone marrow plasma cell percentage >=10%. Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing. Development of hypercalcemia. Participants who died or dropped out due to any reason without progression will be censored with the day of death or drop-out, respectively and who are alive at the end of the study without any progression was censored with the last available date.|Up to 1 year and 4 months (From date of first participant randomization [20 December 2004] up to interim analysis cut-off date [28 April 2006])|Intent-to-treat (ITT) included all the randomized participants.||Months||95% Confidence Interval|Median
705028|NCT00105534|Secondary|Participants Who Achieved Bacteriological Eradication|Bacterial eradication is defined as the eradication of the causative pathogens as indicated by the absence of growth (0 colony forming units/mL) of the original infecting organism(s).|Visit 3 (Day 6-7)|Per protocol population (defined as all randomized participants who had administered at least one drop of study drug, who had eye cultures indicating pathogenic bacteria levels as well as the clinical signs of conjunctivitis at Visit 1 and had at least one post first dose clinical assessment) with last observation carried forward.||Participants|||Number
705029|NCT00105534|Primary|Participants Who Achieved Clinical Resolution|Clinical Resolution is defined as absence of all three clinical signs: ocular discharge, bulbar conjunctival injection, and palpebral conjunctival injection.|Visit 3 (Days 6-7)|Per protocol population (defined as all randomized participants who had administered at least one drop of study drug, who had eye cultures indicating pathogenic bacteria levels as well as the clinical signs of conjunctivitis at Visit 1 and had at least one post first dose clinical assessment) with last observation carried forward.||Participants|||Number
705038|NCT00105586|Secondary|Quality of Life|Role -emotional impairment score from the Late-Life Function and Disability Instrument (min score=0, significant impairment; max score=100, no impairment).|Measured at Week 12|Quality of Life scales were collected on all participants randomized to Escitalopram and placebo||units on a scale||Standard Deviation|Mean
705039|NCT00105586|Primary|Response Using Clinical Global Impressions-Improvement Scale (CGI-I)|Cumulative incident response of anxiety symptom improvement on CGI-I, with 1 (very much improved) to 2 (much improved) indicated as response. Scores synthesized from anxiety rating scale scores, including Penn State Worry Questionnaire (PSWQ) and Hamilton Anxiety Scale (HamA).|Measured at Weeks 1-12|||participants|||Number
705043|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Calcium - Maintenance Phase||Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.||millimoles per Liter||Standard Deviation|Mean
705044|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Alanine Aminotransferase (ALT) - Maintenance Phase||Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.||Units per Liter||Standard Deviation|Mean
705045|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Total Protein - Continuation Phase||Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.||grams per Liter||Standard Deviation|Mean
705046|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Monocytes - Continuation Phase||Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.||Giga per Liter||Standard Deviation|Mean
705047|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Mean Cell Volume (MCV) - Continuation Phase||Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.||femtoliters||Standard Deviation|Mean
705048|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Mean Cell Hemoglobin - Continuation Phase||Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.||millimoles per Liter||Standard Deviation|Mean
705049|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Low Density Lipoprotein (LDL) Cholesterol (Direct) - Continuation Phase||Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.||millimoles per Liter||Standard Deviation|Mean
705050|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Leukocyte Count - Continuation Phase||Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.||Giga per Liter||Standard Deviation|Mean
705051|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hemoglobin - Continuation Phase||Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.||millimoles per Liter||Standard Deviation|Mean
705052|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hematocrit - Continuation Phase||Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.||Actual count||Standard Deviation|Mean
705053|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Gamma-Glutamyl Transferase - Continuation Phase||Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.||Units per Liter||Standard Deviation|Mean
705054|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Erythrocyte Count - Continuation Phase||Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.||Tera per Liter||Standard Deviation|Mean
705055|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Calcium - Continuation Phase||Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.||millimoles per Liter||Standard Deviation|Mean
705056|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Bilirubin, Total - Continuation Phase||Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.||micromoles per Liter||Standard Deviation|Mean
705057|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Bilirubin, Direct - Continuation Phase||Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.||micromoles per Liter||Standard Deviation|Mean
705058|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Bicarbonate, HCO3 - Continuation Phase||Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.||millimoles per Liter||Standard Deviation|Mean
705059|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Albumin - Continuation Phase||Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.||grams per Liter||Standard Deviation|Mean
705060|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Uric Acid - Acute Phase||Week 0 and Week 10|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.||micromoles per Liter||Standard Deviation|Mean
705061|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Total Protein - Acute Phase||Week 0 and Week 10|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.||grams per Liter||Standard Deviation|Mean
705062|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Sodium - Acute Phase||Week 0 and Week 10|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.||millimoles per Liter||Standard Deviation|Mean
731772|NCT00399542|Secondary|Month 3 Abdominal Pain Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|28 days|ITT with LOCF||units on a scale||Standard Deviation|Mean
705063|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Platelet Count - Acute Phase||Week 0 and Week 10|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.||Giga per Liter||Standard Deviation|Mean
705064|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hemoglobin - Acute Phase||Week 0 and Week 10|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.||millimoles per Liter||Standard Deviation|Mean
705065|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hematocrit - Acute Phase||Week 0 and Week 10|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.||actual count||Standard Deviation|Mean
705066|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Gamma-Glutamyl Transferase - Acute Phase||Week 0 and Week 10|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.||Units per Liter||Standard Deviation|Mean
705067|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Eosinophils - Acute Phase||Week 0 and Week 10|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.||Giga per Liter||Standard Deviation|Mean
705068|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Chloride - Acute Phase||Week 0 and Week 10|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.||millimoles per Liter||Standard Deviation|Mean
705069|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Calcium - Acute Phase||Week 0 and Week 10|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.||millimoles per Liter||Standard Deviation|Mean
705070|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Albumin - Acute Phase||Week 0 and Week 10|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.||grams per Liter||Standard Deviation|Mean
705071|NCT00105989|Secondary|Vital Signs - Change From Baseline to Endpoint in Blood Pressure - Maintenance Phase||Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)|Number of randomized patients with baseline and at least one non-missing post-baseline value. Intent to Treat analysis.||mm Hg||Standard Error|Least Squares Mean
705072|NCT00105989|Secondary|Vital Signs - Change From Baseline to Endpoint in Blood Pressure - Acute and Continuation Phases||Week 0 and Week 10 (Acute) and Week 34 (Continuation)|Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.||mm Hg||Standard Deviation|Mean
705073|NCT00105989|Secondary|Vital Signs - Change From Baseline to Endpoint in Pulse - Maintenance Phase||Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)|Number of randomized patients with baseline and at least one non-missing post-baseline value. Intent to Treat analysis.||beats per minute||Standard Error|Least Squares Mean
705074|NCT00105989|Secondary|Vital Signs - Change From Baseline to Endpoint in Pulse - Acute and Continuation Phases||Week 0 and Week 10 (Acute) and Week 34 (Continuation)|Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.||beats per minute||Standard Deviation|Mean
705075|NCT00105989|Secondary|Vital Signs - Change From Baseline to Endpoint in Weight - Maintenance Phase||Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)|Number of randomized patients with baseline and at least one non-missing post-baseline value. Intent to Treat analysis.||kilograms||Standard Error|Least Squares Mean
705076|NCT00105989|Secondary|Vital Signs - Change From Baseline to Endpoint in Weight - Acute and Continuation Phases||Week 0 and Week 10 (Acute) and Week 34 (Continuation)|Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.||kilograms||Standard Deviation|Mean
705077|NCT00105989|Secondary|Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Females)|A 5-item patient-rated scale measuring 5 domains: sexual drive, arousal (subjective excitement), lubrication/erection (physiological excitement), ability to reach orgasm, orgasm satisfaction. Higher score means worse dysfunction. Total score range is 5-30.|Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)|N=Number of female randomized patients with non-missing baseline and at least one non-missing post-baseline measurement. Female patients who have been sexually active in the previous month respond to Items 3-5. Intent to Treat analysis.||units on a scale||Standard Error|Least Squares Mean
705078|NCT00105989|Secondary|Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Males)|A 5-item patient-rated scale measuring 5 domains: sexual drive, arousal (subjective excitement), lubrication/erection (physiological excitement), ability to reach orgasm, orgasm satisfaction. Higher score means worse dysfunction. Total score range is 5-30.|Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)|N=Number of male randomized patients with non-missing baseline and at least one non-missing post-baseline measurement. Male patients who have been sexually active in the previous month respond to Items 3-5. Intent to Treat analysis.||units on a scale||Standard Error|Least Squares Mean
705079|NCT00105989|Secondary|Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Females)|A 5-item patient-rated scale measuring 5 domains: sexual drive, arousal (subjective excitement), lubrication/erection (physiological excitement), ability to reach orgasm, orgasm satisfaction. Higher score means worse dysfunction. Total score range is 5-30.|Week 0 and Week 10 (Acute) and Week 34 (Continuation)|Number of female enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of female patients who entered Continuation Phase with a baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.||units on a scale||Standard Deviation|Mean
705115|NCT00106028|Secondary|Bone Age (Years), Change From Baseline to Month 24, ITT Population|Bone Age determined by visual assessment of hand / wrist radiographs.|Baseline and Month 24|ITT Population||Years||95% Confidence Interval|Least Squares Mean
705080|NCT00105989|Secondary|Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Males)|A 5-item patient-rated scale measuring 5 domains: sexual drive, arousal (subjective excitement), lubrication/erection (physiological excitement), ability to reach orgasm, orgasm satisfaction. Higher score means worse dysfunction. Total score range is 5-30.|Week 0 and Week 10 (Acute) and Week 34 (Continuation)|Number of male enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of male patients who entered Continuation Phase with a baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.||units on a scale||Standard Deviation|Mean
705081|NCT00105989|Secondary|Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Number of Missed Paid Work Hours - Maintenance Phase|Measures direct and indirect costs. Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Patients self-report on number of days over the past month that they have been either late to work, missed work, or missed usual activities due to symptoms.|Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)|Number of randomized patients who work for pay and missed work due to illness. Intent to Treat analysis.||hours||Standard Error|Least Squares Mean
705082|NCT00105989|Secondary|Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Number of Missed Paid Work Hours - Acute and Continuation Phase|Measures direct and indirect costs. Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Patients self-report on number of days over the past month that they have been either late to work, missed work, or missed usual activities due to symptoms.|Week 0 and Week 10 (Acute) and Week 34 (Continuation)|Number of enrolled patients in the Acute Phase who work for pay and missed work due to illness. Number of patients who entered the Continuation Phase who work for pay and missed work due to illness. Intent to Treat analysis.||hours||Standard Deviation|Mean
705083|NCT00105989|Secondary|Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Average Number of Hours Worked in a Week - Maintenance Phase|Measures direct and indirect costs. Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Patients self-report on number of days over the past month that they have been either late to work, missed work, or missed usual activities due to symptoms.|Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)|Number of randomized patients who work for pay. Intent to Treat analysis.||hours||Standard Error|Least Squares Mean
705084|NCT00105989|Secondary|Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Average Number of Hours Worked in a Week - Acute and Continuation Phases|Measures direct and indirect costs. Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Patients self-report on number of days over the past month that they have been either late to work, missed work, or missed usual activities due to symptoms.|Week 0 and Week 10 (Acute) and Week 34 (Continuation)|Number of enrolled patients in the Acute Phase who work for pay. Number of patients who entered the Continuation Phase who work for pay. Intent to Treat analysis.||hours||Standard Deviation|Mean
705085|NCT00105989|Secondary|Resource Utilization and Hospitalization Module - Visits to Health Care Providers - Maintenance Phase|Measures direct and indirect costs. Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Patients self-report on number of days over the past month that they have been either late to work, missed work, or missed usual activities due to symptoms.|Week 34 through Week 86 (Maintenance Phase)|Number of randomized patients who indicated they had visits to specified health care provider. Intent to Treat analysis.||visits||Standard Error|Least Squares Mean
705086|NCT00105989|Secondary|Resource Utilization and Hospitalization Module - Visits to Health Care Providers - Acute and Continuation Phases|Measures direct and indirect costs. Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Patients self-report on number of days over the past month that they have been either late to work, missed work, or missed usual activities due to symptoms.|Week 0 through Week10 (Acute) through Week 34 (Continuation)|"Number of enrolled patients in Acute Phase and number who entered Continuation Phase who indicated they had visits to specified health care provider. Intent to Treat analysis. Note: Other Mental Health Care Worker wasn't included in table (1 patient in Acute). Other Health Care Worker wasn’t included in table (2 patients in Continuation)."||visits||Standard Deviation|Mean
705087|NCT00105989|Secondary|Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Maintenance Phase|Assesses general quality of life. 36 questions covering 8 health domains. Each subscale is scored by summing the individual items and transforming scores into a 0-100 scale, with higher scores indicating better health status or functioning.|Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)|Number of randomized patients with non-missing baseline and at least one non-missing post-baseline measurement. Intent to Treat analysis.||units on a scale||Standard Error|Least Squares Mean
705088|NCT00105989|Secondary|Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase|Assesses general quality of life. 36 questions covering 8 health domains. Each subscale is scored by summing the individual items and transforming scores into a 0-100 scale, with higher scores indicating better health status or functioning.|Week 0 and Week 10 (Acute) and Week 34 (Continuation)|Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.||units on a scale||Standard Deviation|Mean
705089|NCT00105989|Secondary|Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - Maintenance Phase|The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Total (Global) scores range from 0 to 30 with higher values indicating greater disruption in the patient's work/social/family life. Individual Item scores range from 0 to 10.|Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)|Number of randomized patients with non-missing baseline and at least one non-missing post-baseline measurement. Intent to Treat analysis.||units on a scale||Standard Error|Least Squares Mean
705116|NCT00106028|Secondary|Bone Age (Years), Change From Baseline to Month 12, ITT Population|Bone Age determined by visual assessment of hand / wrist radiographs.|Baseline and Month 12|ITT Population||Years||95% Confidence Interval|Least Squares Mean
705090|NCT00105989|Secondary|Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - Acute and Continuation Phases|The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Total (Global) scores range from 0 to 30 with higher values indicating greater disruption in the patient's work/social/family life. Individual Item scores range from 0 to 10.|Week 0 and Week 10 (Acute) and Week 34 (Continuation)|Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.||units on a scale||Standard Deviation|Mean
705091|NCT00105989|Secondary|Change From Baseline to Endpoint in Symptom Questionnaire-Somatic Subscale (SQ-SS) - Maintenance Phase|The Somatic subscale consists of 23 items to be completed by the patient that focus on somatic symptoms. Question answers are either yes/no or true/false. Negative response is scored at 1; positive response is scored as 0. Total Somatic subscale scores range from 0-23, where higher scores indicate greater symptom severity.|Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)|Number of randomized patients with non-missing baseline and at least one non-missing post-baseline measurement. Intent to Treat analysis.||units on a scale||Standard Error|Least Squares Mean
705092|NCT00105989|Secondary|Change From Baseline to Endpoint in Symptom Questionnaire-Somatic Subscale (SQ-SS) - Acute and Continuation Phases|The Somatic subscale consists of 23 items to be completed by the patient that focus on somatic symptoms. Question answers are either yes/no or true/false. Negative response is scored at 1; positive response is scored as 0. Total Somatic subscale scores range from 0-23, where higher scores indicate greater symptom severity.|Week 0 and Week 10 (Acute) and Week 34 (Continuation)|Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.||units on a scale||Standard Deviation|Mean
705093|NCT00105989|Secondary|Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Maintenance Phase|VAS for pain consists of 6 questions that assess overall pain, headache, back pain, shoulder pain, pain interference with daily activities, and pain while awake. Participant rates pain on a 100 millimeter (mm) line between two anchors (0 = no pain and 100 = very severe pain).|Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.||units on a scale||Standard Error|Least Squares Mean
705094|NCT00105989|Secondary|Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Acute and Continuation Phase|VAS for pain consists of 6 questions that assess overall pain, headache, back pain, shoulder pain, pain interference with daily activities, and pain while awake. Participant rates pain on a 100 millimeter (mm) line between two anchors (0 = no pain and 100 = very severe pain).|Week 0 and Week 10 (Acute) and Week 34 (Continuation)|Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.||units on a scale||Standard Deviation|Mean
705095|NCT00105989|Secondary|Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Maintenance Phase|Core and Maier subscales assess symptoms of depression (scores:0-20=Core; 0-24=Maier). Higher numbers indicate more severe symptoms. Anxiety/Somatization subscale assesses severity of anxiety (0-18). Retardation subscale assesses dysfunction in mood and work (0-14). Sleep subscale assesses insomnia (0-6). Depressed Mood item (0-4).|Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)|Number of randomized patients with a baseline and at least one non-missing post-baseline assessment. Intent to Treat analysis.||units on a scale||Standard Error|Least Squares Mean
705096|NCT00105989|Secondary|Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Acute and Continuation Phases|Core and Maier subscales assess symptoms of depression (scores:0-20=Core; 0-24=Maier). Higher numbers indicate more severe symptoms. Anxiety/Somatization subscale assesses severity of anxiety (0-18). Retardation subscale assesses dysfunction in mood and work (0-14). Sleep subscale assesses insomnia (0-6). Depressed Mood Item (0-4).|Week 0 and Week 10 (Acute) and Week 34 (Continuation)|Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.||units on a scale||Standard Deviation|Mean
705097|NCT00105989|Secondary|Mean Values at Endpoint in Patient's Global Impressions of Improvement (PGI-I) - Maintenance Phase|A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).|Week 86 (Maintenance Phase)|Number of randomized patients with a baseline and at least one non-missing post-baseline assessment. Intent to Treat analysis.||units on a scale||Standard Error|Least Squares Mean
705098|NCT00105989|Secondary|Mean Values at Endpoint in Patient's Global Impressions of Improvement (PGI-I) - Acute and Continuation Phases|A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).|Week 10 (Acute) and Week 34 (Continuation)|Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.||units on a scale||Standard Deviation|Mean
705099|NCT00105989|Secondary|Change From Baseline to Endpoint in Clinical Global Impressions (CGI) Severity Scale - Maintenance Phase|Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients.|Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)|Number of randomized patients with a baseline and at least one non-missing post-baseline assessment. Intent to Treat analysis.||units on a scale||Standard Error|Least Squares Mean
705117|NCT00106028|Secondary|Wong-Baker FACES Pain Rating Scale - Change From Baseline to Month 12, ITT Population|Wong-Baker FACES Pain Rating Scale (pain assessment scale using facial expressions, translated into a range from 0= no pain [smiling face] to 10= worst pain possible [distorted face with tears]; negative values indicate decrease in pain). Reference: Wong DL et al.|Baseline and Month 12|ITT Population||Units on a Scale||95% Confidence Interval|Least Squares Mean
705100|NCT00105989|Secondary|Change From Baseline to Endpoint in Clinical Global Impressions (CGI) Severity Scale - Acute and Continuation Phases|Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Week 0 and Week 10 (Acute) and Week 34 (Continuation)|Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.||units on a scale||Standard Deviation|Mean
705101|NCT00105989|Secondary|Change From Baseline to Endpoint in 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score - Maintenance Phase|The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (absent, mild, moderate, severe, very severe) or a 3-point scale (absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).|Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)|Number of randomized patients with a baseline and at least one non-missing post-baseline measurement. Intent to Treat analysis.||units on a scale||Standard Error|Least Squares Mean
705102|NCT00105989|Secondary|Change From Baseline to Endpoint in 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score - Acute and Continuation Phases|The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).|Week 0 and Week 10 (Acute) and Week 34 (Continuation)|Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.||units on a scale||Standard Deviation|Mean
705103|NCT00105989|Secondary|Loss of Response at Any Time|Loss of response was defined as a HAMD-17 total score >9 and a CGI-Severity score >2 at any one time during the double-blind maintenance phase of the study regardless of whether or not they subsequently regained response or not.|Every Visit from Week 35 up to Week 86 (Maintenance Phase)|Number of randomized patients with at least one non-missing post-baseline assessment during the double-blind maintenance therapy phase. Intent to Treat analysis.||participants|||Number
705104|NCT00105989|Secondary|Percentage of Participants With Greater Than or Equal to 50% Worsening After Time (t) in Days|Worsening occurs if patient had a >=50% increase from baseline on the 17-Item Hamilton Depression Rating Scale (HAMD-17) total score and a Clinical Global Impression-Severity (CGI-S) score >=3 at any time during the double-blind maintenance therapy phase.|Every Visit from Week 34 up to Week 86 (Maintenance Phase)|Number of randomized patients with at least one non-missing post-baseline assessment during the double blind maintenance therapy phase. Intent to Treat analysis.||percentage of participants|||Number
705105|NCT00105989|Secondary|Recurrence Count|Number of participants who experienced a depressive recurrence at any time during the double-blind maintenance therapy phase.|Every Visit from Week 35 up to Week 86 (Maintenance Phase)|Number of randomized patients with at least one non-missing postbaseline assessment during the double-blind maintenance therapy phase. Intent to Treat analysis.||participants|||Number
705106|NCT00105989|Primary|Percentage of Participants With Depressive Recurrence After Time (t) in Days|Recurrence: Clinical Global Impression-Severity (CGI-S) score >=4 and met Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for major depressive disorder (MDD); had 3 consecutive visits where re-emergence criteria met; had total of 10 visits where re-emergence criteria was satisfied; discontinued due to lack of efficacy.|Every Visit from Week 34 up to Week 86 (Maintenance Phase)|All randomized patients. Intent to Treat analysis.||percentage of participants|||Number
705107|NCT00106002|Secondary|Overall Survival Time|Defined as the time from date of first dose to time of death due to any cause.|every 14 day cycle, during 30-days post-therapy follow-up, and every 6 months during the long-term follow-up|Intent to treat population (in order to follow protocol, one patient who did not take any study drug was excluded from this analysis)||months||Full Range|Median
705108|NCT00106002|Secondary|Progression-Free Survival Time|Defined as the time from date of first dose to the first observation of disease progression, or death due to any cause.|every 3 cycles (approximately 6-7 weeks) or until patient has disease progression|Intent to treat population (in order to follow protocol, one patient who did not take study drug was excluded from this analysis)||months||Full Range|Median
705109|NCT00106002|Secondary|Duration of Tumor Response|Defined as time from first observation of complete response or partial response to the first observation of progressive disease or death due to any cause.|every 3 cycles (approximately 6-7 weeks) or until patient has disease progression|Only applies to patients who had a complete or partial response||months||Full Range|Median
705110|NCT00106002|Secondary|Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants)|Participants rated for toxicity prior to each cycle using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events v3.0 (CTCAE). Grades range from 0 (no AE or within normal limits) to 5 (death related to AE).|every 14 day cycle, and during 30-days post-therapy follow-up and long-term follow-up|||participants|||Number
705111|NCT00106002|Primary|Overall Tumor Response|"Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve (respond), stay the same (stable), or worsen (progression) during treatment."|every 3 cycles (approximately 6-7 weeks) or until patient has disease progression|||participants|||Number
705112|NCT00106028|Secondary|Annualized Growth Velocity - Change From Baseline to Month 36, ITT Population|Annualized Growth Velocity [= bone age change from baseline x (365.25/time in days between baseline and the bone age measurement)]|Baseline and Month 36|ITT Population, Number of Participants Analyzed = Number of participants at baseline and Month 12 data||Change in Annualized Growth Velocity||95% Confidence Interval|Least Squares Mean
705113|NCT00106028|Secondary|Annualized Growth Velocity - Change From Baseline to Month 12, ITT Population|Annualized Growth Velocity [= bone age change from baseline x (365.25/time in days between baseline and the bone age measurement)]|Baseline and Month 12|ITT Population, Number of Participants Analyzed = Number of participants at baseline and Month 12 data||Change in Annualized Growth Velocity||95% Confidence Interval|Least Squares Mean
705114|NCT00106028|Secondary|Bone Age (Years), Change From Baseline to Month 36, ITT Population|Bone Age determined by visual assessment of hand / wrist radiographs.|Baseline and Month 36|ITT Population||Years||95% Confidence Interval|Least Squares Mean
705118|NCT00106028|Secondary|Urine NTX/Cr - Percent Change From Baseline at Month 36, ITT Population|Urine type-I collagen N-telopeptide/creatinine (NTX/Cr; bone resorption marker). Negative percent changes indicate response to treatment.|Baseline and Month 36|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
705119|NCT00106028|Secondary|Urine NTX/Cr - Percent Change From Baseline at Month 24, ITT Population|Urine type-I collagen N-telopeptide/creatinine (NTX/Cr; bone resorption marker). Negative percent changes indicate response to treatment.|Baseline and Month 24|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
705120|NCT00106028|Secondary|Urine NTX/Cr - Percent Change From Baseline at Month 12, ITT Population|Urine type-I collagen N-telopeptide/creatinine (NTX/Cr; bone resorption marker). Negative percent changes indicate response to treatment.|Baseline and Endpoint / Month 12|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
705121|NCT00106028|Secondary|Serum BAP - Percent Change From Baseline to Month 36, ITT Population|Serum Bone Alkaline Phosphatase (BAP - bone formation marker). Negative percent changes indicate response to treatment.|Baseline and 36 Months|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
705122|NCT00106028|Secondary|Serum BAP - Percent Change From Baseline to Month 24, ITT Population|Serum Bone Alkaline Phosphatase (BAP - bone formation marker). Negative percent changes indicate response to treatment.|Baseline and 24 Months|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
705123|NCT00106028|Secondary|Serum BAP - Percent Change From Baseline to Month 12, ITT Population|Serum Bone Alkaline Phosphatase (BAP - bone formation marker). Negative percent changes indicate response to treatment.|Baseline and 12 Months|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
705124|NCT00106028|Secondary|Number of Clinical Fractures, Month 12, ITT Population|Long bones include radius, ulna, humerus, tibia, fibula, femur, upper limb and lower limb fracture.|12 Months|ITT Population||Participants|||Number
705125|NCT00106028|Secondary|Probability of Fracture in 12 Months (Kaplan-Meier Cumulative Incidence), ITT Population|Long bones include radius, ulna, humerus, tibia, fibula, femur, upper limb and lower limb fracture.|Time to First Event (days) up to 12 Months|ITT Population||Probability of Fractures|||Number
705126|NCT00106028|Secondary|Incidence New Vertebral Fractures by SQ Score, Patients Aged 10-15 Years, Month 12, ITT Population|Patients aged 10-15 years with new morphometric vertebral fractures as measured by SQ analysis of x-rays using the Genant scoring system at Month 12 +/- 14 days. (Ref: Genant 1993). SQ Score mild - 0/no fracture to Grade 1, Moderate to Severe - change from 0/no fracture to Grade 2-3.|Month 12|ITT Population, Number of Participants Analyzed = Number of participants at baseline and Month 12 data||Participants|||Number
705127|NCT00106028|Secondary|Incidence New Vertebral Fractures by SQ (Semi-Quantitative) Score, Patients Aged 4-9 Years, Month 12, ITT Population|Patients aged 4-9 years with new morphometric vertebral fractures as measured by SQ analysis of x-rays using the Genant scoring system at Month 12 +/- 14 days. (Ref: Genant 1993). SQ Score mild - 0/no fracture to Grade 1, Moderate to Severe - change from 0/no fracture to Grade 2-3.|Month 12|ITT Population, Number of Participants Analyzed = Number of participants with baseline and Month 12 data||Participants|||Number
705128|NCT00106028|Secondary|Categorization by Number of New Morphometric Vertebral Fracture at Month 36, ITT|Patients with 1 or more New Morphometric Vertebral Fracture as measured by SQ analysis of x-rays using the Genant scoring system (Ref: Genant 1993). SQ-Scores range from 0 (no fracture) to 3 (severe fracture). Incidence = SQ score is 0 at baseline and >0 at post-baseline.|Baseline and Month 36|ITT Population||Participants|||Number
705129|NCT00106028|Secondary|Categorization by Number of New Morphometric Vertebral Fracture at Month 12, ITT|Patients with 1 or more New Morphometric Vertebral Fracture as measured by SQ analysis of x-rays using the Genant scoring system (Ref: Genant 1993). SQ-Scores range from 0 (no fracture) to 3 (severe fracture). Incidence = SQ score is 0 at baseline and >0 at post-baseline.|Baseline and Month 12|ITT Population||Participants|||Number
705130|NCT00106028|Secondary|New Morphometric Vertebral Fracture at Month 36, ITT Population|Morphometric Vertebral Fracture measured by SQ analysis of x-rays using the Genant scoring system. (Ref: Genant 1993). SQ-Scores range from 0 (no fracture) to 3 (severe fracture). New fracture = SQ score is 0 at baseline and >0 at the specified end visit.|Baseline and Month 36|ITT Population||Participants|||Number
705131|NCT00106028|Secondary|New Morphometric Vertebral Fracture at Month 12, ITT Population|Morphometric Vertebral Fracture measured by semi-quantitative (SQ) analysis of x-rays using the Genant scoring system at endpoint. (Ref: Genant 1993). SQ-Scores range from 0 (no fracture) to 3 (severe fracture). New fracture = SQ score is 0 at baseline and >0 at the specified end visit.|Baseline and Month 12|ITT Population||Participants|||Number
705132|NCT00106028|Secondary|Percent Change From Baseline in Total Body Bone Area Month 36, ITT Population||Baseline and Month 36|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
705133|NCT00106028|Secondary|Percent Change From Baseline in Total Body Bone Area Month 24, ITT Population||Baseline and Month 24|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
705134|NCT00106028|Secondary|Percent Change From Baseline in Total Body Bone Area Month 12, ITT Population||Baseline and Month 12|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
705135|NCT00106028|Secondary|Percent Change From Baseline in Lumbar Spine Bone Area at Month 36, ITT Population|Measured by DXA.|Baseline and Month 36|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
705136|NCT00106028|Secondary|Percent Change From Baseline in Lumbar Spine Bone Area at Month 24, ITT Population|Measured by DXA.|Baseline and Month 24|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
705137|NCT00106028|Secondary|Percent Change From Baseline in Lumbar Spine Bone Area at Month 12, ITT Population|Measured by DXA.|Baseline and Month 12|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
705138|NCT00106028|Secondary|Total Body Z-score- Percent Change From Baseline to Month 36, ITT Population|"Total Body Z-score - number of standard deviations a patient's BMD differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are best values and negative values are worst values."|Baseline and Month 36|ITT Population||Units on a Scale||95% Confidence Interval|Least Squares Mean
705406|NCT00106938|Secondary|Freedom From Clinically Indicated Target Lesion Revascularization|Freedom from CITLR was defined as freedom from reintervention for ≥ 50% restenosis in recently symptomatic patients and ≥ 80% restenosis in asymptomatic patients.|0 to 730 days|||percentage of partcipants|||Number
705139|NCT00106028|Secondary|Total Body Z-score- Percent Change From Baseline to Month 24, ITT Population|"Total Body Z-score - number of standard deviations a patient's BMD differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are best values and negative values are worst values."|Baseline and Month 24|ITT Population||Units on a Scale||95% Confidence Interval|Least Squares Mean
705140|NCT00106028|Secondary|Total Body Z-score- Percent Change From Baseline to Month 12, ITT Population|"Total Body Z-score - number of standard deviations a patient's BMD differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are best values and negative values are worst values."|Baseline and Month 12|ITT Population, Population Description Number of Participants Analyzed = Number of participants at baseline and LOCF data||Units on a Scale||95% Confidence Interval|Least Squares Mean
705141|NCT00106028|Secondary|Lumbar Spine Z-score - Percent Change From Baseline to Month 36, ITT Population|"Lumbar Spine Z-score - number of standard deviations a patient's BMD differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are best values and negative values are worst values."|Baseline and Month 36|ITT Population||Units on a Scale||95% Confidence Interval|Least Squares Mean
705142|NCT00106028|Primary|Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Month 12, ITT Population|Lumbar Spine Bone Mineral Density (BMD) measured by dual-energy x-ray absorptiometry (DXA)and read by central reader. Duplicate scans obtained at screening and Month 12.|Baseline and Month 12|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
705143|NCT00106028|Secondary|Lumbar Spine Z-score - Percent Change From Baseline to Month 24, ITT Population|"Lumbar Spine Z-score - number of standard deviations a patient's BMD differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are best values and negative values are worst values."|Baseline and Month 24|ITT Population||Units on a Scale||95% Confidence Interval|Least Squares Mean
705144|NCT00106028|Secondary|Lumbar Spine Z-score - Percent Change From Baseline to Month 12, ITT Population|"Lumbar Spine Z-score - number of standard deviations a patient's BMD differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are best values and negative values are worst values."|Baseline and Month 12|ITT Population||Units on a Scale||95% Confidence Interval|Least Squares Mean
705145|NCT00106028|Secondary|Percent Change From Baseline in Total Body BMC at Month 36, ITT Population||Baseline and Month 36|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
705146|NCT00106028|Secondary|Percent Change From Baseline in Total Body BMC at Month 24, ITT Population||Baseline and Month 24|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
705147|NCT00106028|Secondary|Percent Change From Baseline in Total Body BMC at Month 12, ITT Population||Baseline and Month 12|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
705148|NCT00106028|Secondary|Percent Change From Baseline in Lumbar Spine BMC (Bone Mineral Content) at Month 36, ITT Population||Baseline and Month 36|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
705149|NCT00106028|Secondary|Percent Change From Baseline in Lumbar Spine BMC (Bone Mineral Content) at Month 24, ITT Population||Baseline and Month 24|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
705150|NCT00106028|Secondary|Percent Change From Baseline in Lumbar Spine BMC (Bone Mineral Content) at Month 12, ITT Population||Baseline and Month 12|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
705151|NCT00106028|Secondary|Percent Change From Baseline in Total Body BMD at Month 36, ITT Population|Percent Change from baseline in Total Body Bone Mineral Density (BMD) measured by DXA.|Baseline and Month 36|ITT Population.||Percent Change||95% Confidence Interval|Least Squares Mean
705152|NCT00106028|Secondary|Percent Change From Baseline in Total Body BMD at Month 24, ITT Population|Percent Change from baseline in Total Body Bone Mineral Density (BMD) measured by DXA.|Baseline and Month 24|ITT Population.||Percent Change||95% Confidence Interval|Least Squares Mean
705153|NCT00106028|Secondary|Percent Change From Baseline in Total Body BMD at Month 12, ITT Population|Percent Change from baseline in Total Body Bone Mineral Density (BMD) measured by DXA.|Baseline and Month 12|ITT Population.||Percent Change||95% Confidence Interval|Least Squares Mean
705154|NCT00106028|Secondary|Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Month 36, ITT Population|Lumbar Spine Bone Mineral Density (BMD) measured by dual-energy x-ray absorptiometry (DXA)and read by central reader.|Baseline and Month 36|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
705155|NCT00106028|Secondary|Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Month 24, ITT Population|Lumbar Spine Bone Mineral Density (BMD) measured by dual-energy x-ray absorptiometry (DXA)and read by central reader.|Baseline and Month 24|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
705156|NCT00106080|Secondary|Effect of Intervention on Patient Reported Discussions About Treatment Preferences at Their Last Clinic Visit.|We measured the difference between intervention and control group patients reporting having had a discussion with their clinician about treatment preferences at their last clinic visit.|Assessed 2 weeks after targeted clinic visit|||Proportion of participants reporting||95% Confidence Interval|Number
705157|NCT00106080|Primary|Effect of Intervention on Quality of Patient Clinician Communication About End-of-Life Care(QOC) Scale|The quality of end-of-life communication (QOC) score ranges between 0 and 100, with higher scores indicating better communication between patients and providers.|Measured at enrollment and 2 weeks after targeted clinic visit|||units on a scale||95% Confidence Interval|Mean
705158|NCT00106106|Primary|Ratio of Glutamate to Creatine in the Anterior Cingulate of the Brain, Measured on Day 25|The ratio of glutamate to creatine was determined using magnetic resonance spectroscopy (MRS), a technique that complements magnetic resonance imaging (MRI). MRS is used to determine the concentration of brain metabolites, such as glutamate, in brain tissue. MRS utilizes a magnetic field to look at magnetic nuclei, which absorb and re-emit electromagnetic energy in the presence of the magnetic field. By looking at the peaks in the resultant spectra the structure and concentration of metabolites can be determined.|Day 25|||Ratio of glutamate to creatine||Standard Error|Mean
705407|NCT00106938|Secondary|Freedom From Clinically Indicated Target Lesion Revascularization|Freedom from CITLR was defined as freedom from reintervention for ≥ 50% restenosis in recently symptomatic patients and ≥ 80% restenosis in asymptomatic patients.|0 to 365 days|||percentage of partcipants|||Number
705159|NCT00106106|Primary|Ratio of Glutamate to Creatine in the Anterior Cingulate of the Brain, Measured on Day 4|The ratio of glutamate to creatine was determined using magnetic resonance spectroscopy (MRS), a technique that complements magnetic resonance imaging (MRI). MRS is used to determine the concentration of brain metabolites, such as glutamate, in brain tissue. MRS utilizes a magnetic field to look at magnetic nuclei, which absorb and re-emit electromagnetic energy in the presence of the magnetic field. By looking at the peaks in the resultant spectra the structure and concentration of metabolites can be determined.|Day 4|The analysis of participants was per protocol, i.e., all subjects who completed two MRS scans(Day 4 and Day 25) and for whom there were two measures of the glutamate/creatine ratio||Ratio of glutamate to creatine||Standard Error|Mean
705160|NCT00106119|Secondary|Apolipoprotein B at Liothyronine Treatment Phase||One month of therapy.|||mg/dl||Standard Deviation|Mean
705161|NCT00106119|Secondary|Apolipoprotein B at Levothyroxine Treatment Phase||One month of therapy.|||mg/dl||Standard Deviation|Mean
705162|NCT00106119|Secondary|Apolipoprotein A-I at Liothyronine Treatment Phase||One month of therapy.|||mg/dl||Standard Deviation|Mean
705163|NCT00106119|Secondary|Apolipoprotein A-I at Levothyroxine Treatment Phase||One month of therapy.|||mg/dl||Standard Deviation|Mean
705164|NCT00106119|Secondary|Left Ventricle Mass Index at Liothyronine Treatment Phase||One month of therapy.|||g/m^2||Standard Deviation|Mean
705165|NCT00106119|Secondary|Left Ventricle Mass Index at Levothyroxine Treatment Phase||One month of therapy.|||g/m^2||Standard Deviation|Mean
705166|NCT00106119|Secondary|Resting Energy Expenditure at Liothyronine Treatment Phase||One month of therapy.|||kcal/24 hour||Standard Deviation|Mean
705167|NCT00106119|Secondary|Resting Energy Expenditure at Levothyroxine Treatment Phase||One month of therapy.|||kcal/24 hour||Standard Deviation|Mean
705168|NCT00106119|Secondary|Triglycerides at Liothyronine Treatment Phase||One month of therapy.|||mg/dl||Standard Deviation|Mean
705169|NCT00106119|Secondary|Triglycerides at Levothyroxine Treatment Phase||One month of therapy.|||mg/dl||Standard Deviation|Mean
705170|NCT00106119|Secondary|Total Cholesterol at Liothyronine Treatment Phase||One month of therapy.|||mg/dl||Standard Deviation|Mean
705171|NCT00106119|Primary|Insulin-mediated Glucose Disposal Rate at Liothyronine Treatment Phase||One month of therapy|||mg/kg/min||Standard Deviation|Mean
705172|NCT00106119|Secondary|Total Cholesterol at Levothyroxine Treatment Phase||One month of therapy.|||mg/dl||Standard Deviation|Mean
705173|NCT00106119|Primary|Insulin-mediated Glucose Disposal Rate at Levothyroxine Treatment Phase||One month of therapy.|||mg/kg/min||Standard Deviation|Mean
705174|NCT00106184|Secondary|20% Improvement in Manual Muscle Testing (MMT) Over Baseline on Two Consecutive Time Points (Muscle is the Primary Organ of Involvement, and MMT is the One Objective Measurement of the Definition of Improvement [DOI])|Number of participants with a 20% improvement in MMT over baseline on two consecutive time points.|Week 44 of treatment phase|Intention to Treat (ITT)||Participants|||Number
705175|NCT00106184|Secondary|Response Rates (Proportion of Improved Patients) Between Groups A (Rituximab Wks 0 and 1) and B (Rituximab Wks 8 and 9) at Week 8|"The Definition of Improvement for both adult and pediatric patients will be: 3 of any of the 6 core set measures improved by ≥ 20%, with no more than 2 of the core set measures worsening by ≥25% (worsening measure cannot include the MMT) at two consecutive visits. Of note, the MMT could not be one of the worsening measures.
Core Set Measures Included:
Manual Muscle Testing (MMT)- Muscle Strength
Physician Global Disease Activity VAS Score
Health Assessment Questionnaire Index Score - Physical Function
Patient Global Assessment of Disease Activity VAS score
Extramuscular Activity - Myositis Disease Activity Assessment Tool
2 or more elevated muscle enzymes (Aldolase, CK, AST, ALT, and LDH)"|Week 8 of the treatment phase|Intention to Treat (ITT)||participants|||Number
705176|NCT00106184|Primary|Comparison Between the Time to Improvement Between the Two Groups of IIM (Idiopathic Inflammatory Myopathy) Patients|"The Definition of Improvement for both adult and pediatric patients will be: 3 of any of the 6 core set measures improved by ≥ 20%, with no more than 2 of the core set measures worsening by ≥25% (worsening measure cannot include the MMT) at two consecutive visits. Of note, the MMT could not be one of the worsening measures.
Core Set Measures Included:
Manual Muscle Testing (MMT)- Muscle Strength
Physician Global Disease Activity VAS Score
Health Assessment Questionnaire Index Score - Physical Function
Patient Global Assessment of Disease Activity VAS score
Extramuscular Activity - Myositis Disease Activity Assessment Tool
2 or more elevated muscle enzymes (Aldolase, CK, AST, ALT, and LDH)"|Week 44 of treatment phase|Intention to Treat (ITT)||Weeks||Full Range|Median
705177|NCT00106249|Secondary|Motor Cortex Excitability (Short Intracortical Inhibition)|In 22 OCD patients enrolled in the RCT, we applied the new customized software for acquisition and analysis of neurophysiology data that was developed to allow for automatic control of the TMS devices during motor cortex excitability measures. For the paired-pulse (PP) measurements of short intracortical inhibition (SICI) the interstimulus interval (ISI) was set to 8-12 seconds on a continuous uniform distribution. The FPGA board samples the EMG data, controls the timing of the TMS stimuli, and also controls the intensity of the devices.|Through study completion|Independent sample t-test, right hemisphere SICI||% change in conditioned/control MEP||Full Range|Mean
705178|NCT00106249|Secondary|Motor Cortex Excitability (Motor Threshold)|In 22 OCD patients, who completed the RCT, we applied the new customized software for acquisition and analysis of neurophysiology data that was developed to allow for automatic control of the TMS devices during motor cortex excitability measures. Specifically, the software delivers TMS pulses and automatically determines motor threshold (MT); a descending staircase method is utilized, starting at the intensity at which the optimal site selection for the MT is determined. After each stimulus in the MT experiments, the software would prompt the user to confirm the automated MEP-detection.|Through study completion|repeated measure ANOVA, time X group interaction, right hemisphere MT||% MT change on right hemisphere||Full Range|Mean
705179|NCT00106249|Primary|Clinical Improvement (Yale-Brown Obsessive Compulsive Scale/Y-BOCS)|Response rate was defined as a decrease >25% on the YBOCS-SR. Y-BOCS-Self Report (Baer et al. 1993) is very similar to the clinician-administered one, and has shown excellent internal consistency and test-retest reliability, performing somewhat better than the interview (Steketee et al., 1996); subjects are asked to focus on the main obsessions and main compulsions and to answer five questions: time spent, interference, distress, resistance, and control. Consistent with the interview format, subjects rate each item on a 0 (none) to 4 (extreme) scale.|Through study completion|||percentage of participants|||Number
705180|NCT00106353|Secondary|Number of Participants for Change From Baseline in the Phosphorylation of Mammalian Target of Rapamycin (mTOR) Pathway Proteins: Part 1 and Part 2|Optional bone marrow sampling for pharmacodynamic analysis of effects of study treatment. Data may not be collected for a majority of patients and was not to be summarized if collection was sparse.|Part 1:Baseline,1,2,6,24,168 hrs post-dose of Cycle 1;additional 0 (Pre-dose),24,72,96 hrs, Day 16 to 21 of cycle 2, EOT(within 30 days of last dose); Part 2:Baseline,Day16 to 21 in Cycle 2, at time of disease progression, EOT(within 30 days of last dose)|Data was not analyzed.|||||
705181|NCT00106353|Secondary|Concentration in Plasma (Cp) and Concentration in Plasma at Time Zero (Cp Time 0): Part 1 and Part 2|Pharmacokinetic parameters determined in whole blood; derived from the concentration-versus-time profiles using noncompartmental analysis method. Measured as nanograms per milliliter (ng/mL).|Part 1: 0 (pre-dose), 1, 2, 6, 24, and 168 hrs post-dose of Cycle 1 and 0 (pre-dose), 1, 2, 6, 24, 72, 96, and 168 hrs post-dose of Cycle 2; Part2: 0 (pre-dose), 1, 6, 24, 48, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)|Data was not analyzed.|||||
705182|NCT00106353|Secondary|Clearance (CL): Part 2|CL is a quantitative measure of the rate at which a drug substance is removed from the body.|0 (pre-dose),1, 6, 24, 48, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)|Safety population included all participants who received at least 1 dose of study medication. Here, the 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||L/hr||Standard Deviation|Mean
705183|NCT00106353|Secondary|Area Under the Concentration-time Curve at Steady State (AUCss): Part 2|AUCss is a measure of the serum concentration of the drug at steady state. It is used to characterize drug absorption.|0 (pre-dose), 1, 6, 24, 48, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)|Safety population included all participants who received at least 1 dose of study medication. Here, the 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||hr*ng/mL||Standard Deviation|Mean
705184|NCT00106353|Primary|Percentage of Participants With Objective Response (OR) at Week 12: Part 2|Measured as Complete response (CR), Very good partial response (VGPR), or Partial response (PR) on at least 2 occasions greater than or equal to (>=) 4 weeks apart within first 12 weeks. CR=disappearance of all primary and metastatic lesions; Homovanillic acid, Vanillymandelic acid (HVA/VMA) normal; bone marrow immunocytology negative. VGPR=disappearance of all metastatic lesions (residual areas of uptake on bone permitted); 90 to 99 percent (%) decrease in primary disease measurement; HVA/VMA normal or both decreased >90%. PR=at least 50% decrease in primary and metastatic disease. Number of bone sites decreased by at least 50%.|Week 12|Efficacy evaluable population included all participants who received at least 3 doses of study treatment. Here, the 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure for each group respectively.||percentage of participants|||Number
705185|NCT00106353|Primary|Number of Participants With Potentially Clinically Important (PCI) Values by National Cancer Institute Common Terminology Criteria (NCI-CTC) Grade for Laboratory Values: Part 1|Number of participants who met the PCI criteria (grades 1 through 5) for laboratory values (hematology and serum chemistry). NCI-CTC provides descriptive terminology for adverse event reporting. A grading (severity) scale is provided with grades ranging from 0 (none), 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening or disabling), to 5 (death). Participants may be reported in more than 1 category.|Baseline up to EOT (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.||participants|||Number
705186|NCT00106353|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]: Part 2|AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)|0 (pre-dose), 1, 6, 24, 48, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)|Safety population included all participants who received at least 1 dose of study medication. Here, the 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||hr*ng/mL||Standard Deviation|Mean
705187|NCT00106353|Secondary|Plasma Decay Half-Life (t1/2): Part 2|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 1, 6, 24, 48, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)|Safety population included all participants who received at least 1 dose of study medication. Here, the 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure for.||hr||Standard Deviation|Mean
705188|NCT00106353|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax): Part 2||0 (pre-dose),1, 6, 24, 48, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)|Safety population included all participants who received at least 1 dose of study medication. Here, the 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||hr||Full Range|Median
705189|NCT00106353|Secondary|Average Plasma Concentration (Cavg): Part 2||0 (pre-dose), 1, 6, 24, 48, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)|Safety population included all participants who received at least 1 dose of study medication. Here, the 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||ng/mL||Standard Deviation|Mean
705190|NCT00106353|Secondary|Maximum Observed Plasma Concentration (Cmax): Part 2||0 (pre-dose), 1, 6, 24, 48, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)|Safety population included all participants who received at least 1 dose of study medication. Here, the 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||ng/mL||Standard Deviation|Mean
705191|NCT00106353|Secondary|Number of Participants With Potentially Clinically Important (PCI) Values by National Cancer Institute Common Terminology Criteria (NCI-CTC) Grade for Laboratory Values: Part 2|Number of participants who met the PCI criteria (grades 1 through 5) for laboratory values (hematology and serum chemistry). NCI-CTC provides descriptive terminology for adverse event reporting. A grading (severity) scale is provided with grades ranging from 0 (none), 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening or disabling), to 5 (death). Participants may be reported in more than 1 category.|Baseline up to EOT (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.||participants|||Number
705408|NCT00106938|Secondary|Freedom From Clinically Indicated Target Lesion Revascularization(CI-TLR)|Freedom from CI-TLR was defined as freedom from reintervention for ≥ 50% restenosis in recently symptomatic patients and ≥ 80% restenosis in asymptomatic patients.|0 to 180 days|||percentage of partcipants|||Number
705192|NCT00106353|Secondary|Number of Participants With Potentially Clinically Important (PCI) Changes in Vital Signs: Part 2|Number of participants who met the criteria for PCI changes (based on baseline values before treatment); criteria defined as body temperature >39 degrees C, respiratory rate >20 bpm, and systolic and diastolic BP >200/110 mmHg. Participants may be reported in more than 1 category.|Baseline up to EOT (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.||participants|||Number
705193|NCT00106353|Primary|Number of Participants With Potentially Clinically Important (PCI) Changes in Vital Signs: Part 1|Number of participants who met the criteria for PCI changes (based on baseline values before treatment); criteria defined as body temperature >39 degrees Celsius (C), respiratory rate >20 beats per minute (bpm), and systolic and diastolic blood pressure (BP) >200/110 millimeters of mercury (mmHg). Participants may be reported in more than 1 category.|Baseline up to EOT (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.||participants|||Number
705194|NCT00106353|Primary|Number of Participants With Adverse Events Causing Dose Reduction of Study Treatment: Part 1|Dose reduction for individual participant allowed if a dose limiting toxicity (DLT) occurred; may continue treatment following reduction by 1 to 2 dose levels (determined by investigator and medical monitor). DLT= failure to recover to National Cancer Institute Common Terminology Criteria for AEs (NCI-CTCAE) version 3.0 grade 0 to 2 (or within 1 grade of starting values for pre-existing laboratory abnormalities) from a treatment-related toxicity within 3 weeks (leading to a treatment delay of >3 weeks) unless investigator and medical monitor agree participant should remain in the study.|Baseline up to EOT (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.||participants|||Number
705195|NCT00106353|Primary|Number of Participants With Adverse Events Causing Temporary Stop of Study Treatment: Part 1|Temporary interruption of study treatment; may be followed by resumption of study treatment at current dose or dose modification as determined by the investigator and medical monitor.|Baseline up to EOT (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.||participants|||Number
705196|NCT00106353|Primary|Number of Participants With Drug Related Serious Adverse Events (SAEs): Part 1|SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability / incapacity or are a congenital anomaly or birth defect in the offspring of a study subject. Participants with documented study treatment toxicity were followed weekly until recovering. After the 30 day reporting period, only SAEs believed to be related to study treatment were to be reported.|Baseline up to EOT (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.||participants|||Number
705197|NCT00106353|Primary|Number of Participants Who Died: Part 1|Deaths were reported from baseline throughout the 30 day period after last study treatment. After the 30 day reporting period, only deaths believed related to study treatment were to be reported (as SAEs).|Baseline up to EOT (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.||participants|||Number
705198|NCT00106353|Primary|Number of Participants With Drug Related Grade 3 and Higher Treatment Emergent Adverse Events (TEAEs): Part 1|TEAEs are events that occurred on or after initial treatment that were absent before treatment or worsened during the treatment period relative to the pretreatment state. AEs that occurred within 30 days of the last administration of study treatment can be attributed to the treatment period. National Cancer Institute (NCI)-graded Common Toxicity Criteria (CTC) provides descriptive terminology for adverse event reporting. A grading (severity) scale is provided for each adverse event term. Grades range from 0 (none) to 5 (death).|Baseline up to EOT (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.||participants|||Number
705199|NCT00106353|Primary|Number of Participants With Drug Related Treatment Emergent Adverse Events (TEAEs): Part 1|TEAEs are events that occurred on or after initial treatment that were absent before treatment or worsened during the treatment period relative to the pretreatment state. AEs that occurred within 30 days of the last administration of study treatment can be attributed to the treatment period.|Baseline up to EOT (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.||participants|||Number
705200|NCT00106353|Secondary|Number of Participants With Adverse Events Causing Dose Reduction of Study Treatment: Part 2|Dose reduction for individual participant allowed if a DLT occurred; may continue treatment following reduction by 1 to 2 dose levels (determined by investigator and medical monitor). DLT= failure to recover to National Cancer Institute Common Terminology Criteria for AEs (NCI-CTCAE) version 3.0 grade 0 to 2 (or within 1 grade of starting values for pre-existing laboratory abnormalities) from a treatment-related toxicity within 3 weeks (leading to a treatment delay of >3 weeks) unless investigator and medical monitor agree participant should remain in the study.|Baseline up to EOT (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.||participants|||Number
705201|NCT00106353|Secondary|Number of Participants With Adverse Events Causing Temporary Stop of Study Treatment: Part 2|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Temporary interruption of study treatment may be followed by resumption of study treatment at current dose or dose modification as determined by the investigator and medical monitor.|Baseline up to EOT (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.||participants|||Number
705202|NCT00106353|Secondary|Number of Participants With Drug Related Serious Adverse Events (SAEs): Part 2|An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Participants with documented study treatment toxicity were followed weekly until recovering. After the 30 day reporting period, only SAEs believed to be related to study treatment were to be reported.|Baseline up to EOT (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.||participants|||Number
705565|NCT00110890|Primary|Number of Participants With Mean PTH ≤ 300 pg/mL|Number of participants with mean parathyroid hormone (PTH) ≤ 300 pg/mL during the efficacy assessment phase|Efficacy Assessment Phase (weeks 17 to 23)|Full Analysis Set, composed of all randomized participants with imputation using modified last value carried forward (mLVCF)||Participants|||Number
705203|NCT00106353|Secondary|Number of Participants Who Died: Part 2|Deaths were reported from baseline throughout the 30 day period after last study treatment. After the 30 day reporting period, only deaths believed related to study treatment were to be reported (as SAEs).|Baseline up to EOT (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.||participants|||Number
705204|NCT00106353|Secondary|Number of Participants With Drug Related Grade 3 and Higher Treatment Emergent Adverse Events (TEAEs): Part 2|Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. NCI-CTC provides descriptive terminology for adverse event reporting. A grading (severity) scale is provided for each adverse event term. Grades range from 0 (none) to 5 (death).|Baseline up to EOT (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.||participants|||Number
705205|NCT00106353|Secondary|Number of Participants With Drug Related Treatment Emergent Adverse Events (TEAEs): Part 2|Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to EOT (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.||participants|||Number
705206|NCT00106353|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Part 2|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to EOT (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.||participants|||Number
705207|NCT00106353|Secondary|Percentage of Participants Exhibiting Freedom From Progression at Week 12: Part 2|Freedom from progression measured as Stable Disease (SD) or better and no Progressive Disease (PD); (CR+VGPR+Mixed Response [MR]+PR+SD). CR=disappearance of all primary and metastatic lesions. VGPR=disappearance of all metastatic lesions. MR=no new lesions; at least 50% decrease in any 1 disease measurement with <50% decrease in any other disease measurement or an increase of <25% in any lesion). SD=no new lesions; decrease of <50% in all lesions with no lesion increasing >25%. PD=at least a 25% increase in any disease measurement; or the appearance of 1 or more new lesions.|Week 12|Efficacy evaluable population included all participants who received at least 3 doses of study treatment. Here, the 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure for each group respectively.||percentage of participants||95% Confidence Interval|Number
705208|NCT00106353|Secondary|Percentage of Participants With Best Overall Response: Part 1|Best overall response is the best response recorded from baseline until disease progression or recurrence. Measured as CR, PR, SD, PD, or Unknown. CR=disappearance of all primary and metastatic lesions. PR=at least a 50% decrease in primary disease measurement. SD=no new lesions; decrease of <50% in all lesions with no lesion increasing >25%. PD=any new lesion; at least a 25% increase in any disease measurement (reference smallest disease measurement recorded since start of treatment); or appearance of 1 or more new lesions. Tumor response considered Unknown if assessment prior to Day 37.|Baseline until disease progression or recurrence (actual greatest response day is up to Day 49)|Efficacy evaluable population included all participants who received at least 3 doses of study medication. Here, the 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure for each group respectively.||percentage of participants|||Number
705209|NCT00106353|Secondary|Volume of Distribution at Steady State (Vss): Part 1|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.|0 (pre-dose), 1, 2, 6, 24, and 168 hrs post-dose of Cycle 1 and 0 (pre-dose), 1, 2, 6, 24, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)|Safety population included all participants who received at least 1 dose of study medication. Here, the 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure for each group respectively. Here, 'n' signifies those participants who were evaluable for particular cycle for each group respectively.||Liter||Standard Deviation|Mean
705210|NCT00106353|Secondary|Clearance (CL): Part 1|CL is a quantitative measure of the rate at which a drug substance is removed from the body.|0 (pre-dose), 1, 2, 6, 24, and 168 hrs post-dose of Cycle 1 and 0 (pre-dose), 1, 2, 6, 24, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)|Safety population included all participants who received at least 1 dose of study medication. Here, the 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure for each group respectively. Here, 'n' signifies those participants who were evaluable for particular cycle for each group respectively.||Liter/hr||Standard Deviation|Mean
705211|NCT00106353|Secondary|Area Under the Concentration-Time Curve (AUC): Part 1|AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.|0 (pre-dose), 1, 2, 6, 24, and 168 hrs post-dose of Cycle 1 and 0 (pre-dose), 1, 2, 6, 24, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)|Safety population included all participants who received at least 1 dose of study medication. Here, the 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure for each group respectively. Here, 'n' signifies those participants who were evaluable for particular cycle for each group respectively.||hr*ng/mL||Standard Deviation|Mean
705212|NCT00106353|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]: Part 1|AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t).|0 (pre-dose), 1, 2, 6, 24, and 168 hrs post-dose of Cycle 1 and 0 (pre-dose), 1, 2, 6, 24, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)|Safety population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable for particular cycle for each group respectively.||hr*ng/mL||Standard Deviation|Mean
705837|NCT00112437|Secondary|Percentage Change in Femoral Neck Bone Mineral Density at 12 Months|Percentage change in femoral neck Bone Mineral Density (relative to baseline) at 12 Months|Baseline and 12 months|This analysis was performed at Month 12 using Full-Analysis-Set approach with Last Observation Carried Forward.||Percentage change||95% Confidence Interval|Least Squares Mean
705213|NCT00106353|Secondary|Plasma Decay Half-Life (t1/2): Part 1|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 1, 2, 6, 24, and 168 hrs post-dose of Cycle 1 and 0 (pre-dose), 1, 2, 6, 24, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)|Safety population included all participants who received at least 1 dose of study medication. Here, the 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure for each group respectively. Here, 'n' signifies those participants who were evaluable for particular cycle for each group respectively.||hr||Standard Deviation|Mean
705214|NCT00106353|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax): Part 1||0 (pre-dose), 1, 2, 6, 24, and 168 hrs post-dose of Cycle 1 and 0 (pre-dose), 1, 2, 6, 24, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)|Safety population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable for particular cycle for each group respectively.||hr||Standard Deviation|Mean
705215|NCT00106353|Secondary|Maximum Observed Plasma Concentration (Cmax): Part 1||0 (pre-dose), 1, 2, 6, 24, and 168 hours (hrs) post-dose of Cycle 1 and 0 (pre-dose), 1, 2, 6, 24, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)|Safety population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable for particular cycle for each group respectively.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
705216|NCT00106353|Secondary|Number of Participants Who Reached Maximum Tolerated Dose Due to Dose Limiting Toxicity: Part 1|Maximum tolerated dose (MTD) defined as the dose level at which >=2 of 3 participants or >=2 of 6 participants if the dose level had been expanded, experienced a dose limiting toxicity (DLT) by day 21 after the first dose of study treatment. DLT defined as failure to recover to NCI-CTCAE version 3.0 grade 0 to 2 (or within 1 grade of starting values for pre-existing laboratory abnormalities) from a treatment-related toxicity within 3 weeks (leading to a treatment delay of > 3 weeks) unless the investigator and the medical monitor agree that the subject should remain in the study.|Baseline up to Month 6|Safety population included all participants who received at least 1 dose of study medication.||participants|||Number
705217|NCT00106353|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Part 1|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to End of Treatment (EOT) (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.||participants|||Number
705218|NCT00106392|Secondary|Continence Level as Quantified by Part I of the Prostate Health-Related Quality of Life Questionnaire|Part 1 Urinary Function- Prostate Health-Related Quality-of-Life (QOL) Questionnaire consists of 16 questions asking patients about their continence and urinary habits over the previous four weeks. The responses to all 16 of these questions were added together to calculate an overall score for urinary function. The minimum possible score is 16 and the maximum possible score is 79. A higher score indicates a lower continence level.|24 months|"The number of participants analyzed represents Full Analysis Set (FAS), which is defined as participants evaluated for Efficacy and Safety.
Only participants with a Prostate Health-Related QOL questionnaire at 24 months were included in the calculation."||Overall Score of Urinary Function||Full Range|Median
705219|NCT00106392|Secondary|Time to Achieve Response to Impotence Medications|Time to achieve response to impotence medication was calculated based on the date of the assessment during which the first successful response was recorded. The specific date of the actual response is not reflected; only that it occurred since the previous study visit.|24 months|"The number of participants analyzed represents Full Analysis Set (FAS), which is defined as participants evaluated for Efficacy and Safety.
Only participants who had a successful response to impotence medications were included in the calculations."||Days||Full Range|Median
705220|NCT00106392|Secondary|Percentage of Patients Considered Successful Responders to Impotence Medications|Patients were identified as successful responders if they answered affirmatively in the Patient Sexual Encounter Diary regarding successful sexual intercourse after using impotence medication.|24 months|"The number of participants analyzed represents Full Analysis Set (FAS), which is defined as participants evaluated for Efficacy and Safety.
Only participants who used any impotence medications were included in the calculation."||Percentage of Participants|||Number
705221|NCT00106392|Secondary|Time Taken to Achieve Normalization of the Erectile Function (EF) Domain Score|Erectile function was assessed using the International Index of Erectile Function (IIEF) questionnaire, which consists of 15 questions. The EF domain score is calculated as a sum of scores from questions 1-5 and 15. A clinically meaningful difference is 5 points. Scores range from 1-30 points where a higher score indicates better erectile function. Normal erectile function is defined as greater than or equal to 24 points.Time to achieve normalization of the EF domain score was calculated based on the date of the assessment during which the EF domain score was first greater than or equal to 24.|24 months|"The number of participants analyzed represents Full Analysis Set (FAS), which is defined as participants evaluated for Efficacy and Safety.
Only participants who achieved normal erectile function are included in the calculation."||Days||Full Range|Median
705222|NCT00106392|Secondary|Percentage of Patients Achieving Normal Spontaneous Erectile Function as Measured by the Erectile Function (EF) Domain Score|"Erectile function was assessed using the International Index of Erectile Function (IIEF) questionnaire, which consists of 15 questions. The erectile function domain score is calculated as a sum of scores from questions 1-5 and 15. A clinically meaningful difference is 5 points. The scores range from 1 to 30 points where a higher score indicates better erectile function. Normal erectile function is defined as greater than or equal to 24 points.
Percentages represent the proportions of participants who achieved normal erectile function at any time during the 24 months."|24 months|The number of participants analyzed represents Full Analysis Set (FAS), which is defined as participants evaluated for Efficacy and Safety.||Percentage of Participants|||Number
705409|NCT00106938|Secondary|Composite Morbidity Measure|A pre-specified composite Morbidity Measure (CMM) of cranial and peripheral nerve injury, vascular injury, non-cerebral bleeding, wound complications related to the neck incision or femoral puncture site, and other complications (anesthetic) at 30 days post-procedure.|0 to 30 Days Post-procedure|Intent-to-Treat (ITT) population||participants|||Number
705223|NCT00106392|Primary|Erectile Function Domain Score Between Treated and Untreated Groups|Erectile function was assessed using the International Index of Erectile Function (IIEF) questionnaire, which consists of 15 questions. The erectile function domain score is calculated as a sum of scores from questions 1-5 and 15. A clinically meaningful difference is 5 points. The scores range from 1 to 30 points where a higher score indicates better erectile function. Normal erectile function is defined as greater than or equal to 24 points.|18 months|"The number of participants analyzed represents Full Analysis Set (FAS), which is defined as participants evaluated for Efficacy and Safety.
Only participants with complete IIEF questionnaire data at 18 months are included in the calculation."||Erectile Function Domain Score||Full Range|Median
705224|NCT00106431|Secondary|Percent of Pts With Objective Disease Control|The percent of pts with confirmed ODC (CR, CCR, PR and SD90) based on OPDREC was summarized.|Up to 10 months|Efficacy analysis based on interim analysis of data for as treated population||Percent of participants|||Number
705225|NCT00106431|Secondary|Duration of Objective Disease Control (ODC)|For pts with confirmed ODC (pts with CR, CCR, PR, SD90 [stable disease for 90 days]) based on OPDREC, duration of ODC was summarized with descriptive statistics, including number of censored observations, and 25th, 50th, 75th percentiles of distribution, based on Kaplan-Meier product limit estimates. For pts with confirmed progressive disease (PD), duration of ODC was calculated from first date of study drug to first date of diagnosis of confirmed PD. For pts without confirmed PD, duration of ODC was calculated from first date of study drug to date of the last visit with any OPDREC data.|Up to 10 months; median duration of follow up was 6.0 months|Efficacy analysis based on interim analysis of data for as treated population||Months||Full Range|Median
705226|NCT00106431|Secondary|Decrease in Pruritus Visual Analogue Scale (VAS) Score of ≥30 mm or a Score of 0 for at Least 2 Consecutive Cycles.|Pruritus was reported monthly by pts using a 0 (no itching) to 100 (unbearable itching) mm visual analog scale (VAS). Pts were considered to have significant pruritus if the baseline VAS score was ≥ 30 mm. Clinically meaningful reduction in pruritus was defined as a decrease in VAS score of ≥ 30 mm or a score of 0 for at least 2 consecutive cycles.|Up to 10 months|Patients meeting definition of moderate to severe pruritus on VAS (i.e., had a VAS of >=30 mm)||participants|||Number
705227|NCT00106431|Secondary|Time to Disease Progression|Time To Progression was defined as the duration from the date of the first study drug dose to the date of progression (PD). In this analysis, pts who did not progress were censored at their last evaluation with an OPDREC assessment.|Up to 10 months; median duration of follow up was 6.1 months|Efficacy analysis based on interim analysis of data for as treated population||Months||Full Range|Median
705228|NCT00106431|Secondary|Time to Objective Disease Response|Time to Objective Response was defined as the time in months from first dose date to the first date of objective disease response (later confirmed) and time to CCR was defined as the time in months from first dose date to the first date of CCR (later confirmed).|Up to 10 months|Efficacy analysis based on interim analysis of data for as treated population||Months||Full Range|Median
705229|NCT00106431|Secondary|Duration of Objective Disease Response|Duration of Objective Response was defined as the number of months from the date of the first disease response (clinical complete response [CCR], or partial response [PR]) (later confirmed) until the date of progression and was determined using Kaplan-Meier product-limit estimates. In this analysis, pts who did not progress were censored as of their last evaluation with an OPDREC assessment.|Up to 10 months; median duration of follow up was 5.1 months|Efficacy analysis based on interim analysis of data for as treated population||Months||Full Range|Median
705230|NCT00106431|Primary|The Percent of Patients (Pts) With Objective Disease Response|The percent of pts with confirmed Objective Disease Response (confirmed best responses of complete response [CR], clinical complete response [CCR], or partial response [PR]). Responses were evaluated according to a composite assessment (Objective Primary Disease Response Evaluation Criteria - OPDREC).|6 months|Efficacy analysis based on interim analysis of data for as treated population||Percent of participants|||Number
705231|NCT00106535|Secondary|End of Study: Change From Baseline in Joint Space Narrowing Score at Week 260|Radiographs were taken of a total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint) for a total possible score of 0 (best) to 148 (worst). A lower number change from Baseline indicated a better score.|Baseline, Week 260|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline, Week 104 and post-Week 104 radiographic data available for this outcome measure. Missing data was imputed using linear extrapolation.||Score on a scale||Standard Deviation|Mean
705232|NCT00106535|Secondary|End of Study: Change From Baseline in Erosion Score at Week 260|Radiographs were taken of a total of 14 locations in each hand and wrist and 6 joints in the foot and were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion for a total possible score of 0 (best ) to 142 (worst). A lower number change from Baseline indicated a better score.|Baseline, Week 260|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline, Week 104 and post-Week 104 radiographic data available for this outcome measure. Linear extrapolation was used to impute missing data.||Score on a scale||Standard Deviation|Mean
705233|NCT00106535|Secondary|End of Study: Change From Baseline in Total Sharp-Genant Score at Week 260|Radiographs were taken of each hand and foot at Baseline and Week 260 and evaluated at a central reading service by two independent radiologists using the Genant modified method according to Sharp. Erosion Score: A total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion. Joint Narrowing Score: A total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint).The maximum total erosion score in the hands is 100 and in the feet 42, the maximum scores for joint space narrowing in the hands is 100 and in the feet 48. The maximum modified Sharp score achievable is 290. A lower number change from Baseline indicated a better score. The results were reported based on the treatment the patient was originally randomized to.|Baseline, Week 260|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline, Week 104 and post-Week 104 radiographic data available for this outcome measure. Linear extrapolation was used to impute missing data.||Score on a scale||Standard Deviation|Mean
705234|NCT00106535|Secondary|End of Study: Percentage of Participants With Clinical Relevant Improvement in the SF-36 Score at Week 260|The SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. Clinically relevant improvement is defined as a ≥5 change from Baseline.|Baseline, Week 260|Participants from the Modified Intent-to-treat population, All Tocilizumab Exposure group, with data available for analysis at Baseline and Week 260.||Percentage of participants|||Number
705235|NCT00106535|Secondary|End of Study: Percentage of Participants With Clinical Improvement in the FACIT-Fatigue Score at Week 260|FACIT-F is a 13-item questionnaire. Patients scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the patient's response to the questions (with the exception of 2 negatively stated), the greater the patient's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the patient's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). Clinically relevant improvement is defined as a ≥5 change from Baseline.|Baseline, Week 260|Participants from the Modified Intent-to-treat population, All Tocilizumab Exposure group, with data available for analysis at Baseline and Week 260.||Percentage of participants|||Number
705236|NCT00106535|Secondary|End of Study: Change From Baseline in the Patient's Pain VAS at Week 260|"The patient assessed their pain at Baseline and Week 260 using a 0 to 100 millimeter (mm) horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 mm, and is described as no pain and the right-hand extreme equals 100 mm as unbearable pain. A negative change from Baseline indicated improvement."|Baseline, Week 260|Participants from the Modified Intent-to-treat population, all tocilizumab exposure group, with data available at Baseline and Week 260. No imputation was used for missing VAS assessments.||mm||Standard Deviation|Mean
705237|NCT00106535|Secondary|End of Study: Change From Baseline in the Physician's Global Assessment of Disease Activity VAS at Week 260|The physician’s global assessment of disease activity was assessed using a 0 to 100 mm horizontal visual analogue scale (VAS) by the physician. The left-hand extreme of the line equals 0 mm, and is described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as “maximum disease activity” (maximum arthritis disease activity). A negative change from Baseline indicated improvement.|Baseline, Week 260|Participants from the Modified Intent-to-treat population, all tocilizumab exposure group, with data available at Baseline and Week 260. No imputation was used for missing VAS assessments.||mm||Standard Deviation|Mean
705238|NCT00106535|Secondary|End of Study: Change From Baseline in the Patient's Global Assessment of Disease Activity Visual Analog Scale (VAS) at Week 260|"The patient's global assessment of disease activity was assessed at Baseline and Week 104 using a 0 to 100 mm horizontal visual analogue scale (VAS) by the patient. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). A negative change from Baseline indicated improvement."|Baseline, Week 260|Participants from the Modified Intent-to-treat population, all tocilizumab exposure group, with data available at Baseline and Week 260. No imputation was used for missing VAS assessments.||mm||Standard Deviation|Mean
705239|NCT00106535|Secondary|End of Study: Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 260|HAQ-DI is a self-completed questionnaire specific for RA. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities. Each domain has at least 2 component questions. There are 4 possible responses for each component 0=without any difficulty 1=with some difficulty 2=with much difficulty 3=unable to do. To Calculate HAQ-DI the patient must have a domain score for at least 6 of 8 domains. The HAQ-DI is the sum of the scores, divided by the number of domains that have a score (in range 6-8) for a total possible score minimum/maximum 0 (best) to 3 (worst). A negative change from Baseline indicated improvement.|Baseline, Week 260|Participants from the Modified Intent-to-treat population, All Tocilizumab Exposure group, with data available at Baseline and Week 260. No imputation was used for missing HAQ score.||Score on a scale||Standard Deviation|Mean
705240|NCT00106535|Secondary|End of Study: Change From Baseline in Tender Joint Count at Week 260|68 joints were assessed at Baseline and Week 260 for tenderness and joints are classified as tender/not tender for a total possible swollen joint count of 0 (best) to 68 (worst). A negative change from Baseline indicated improvement.|Baseline, Week 260|Participants from the Modified Intent-to-treat population, All Tocilizumab Exposure group, with data available at Baseline and Week 260. Last observation carried forward was used for missing joint counts.||Joint Count||Standard Deviation|Mean
705241|NCT00106535|Secondary|End of Study: Change From Baseline in Swollen Joint Count at Week 260|66 joints were assessed at Baseline and Week 260 for swelling and joints are classified as swollen/not swollen for a total possible swollen joint count of 0 (best) to 66 (worst). A negative change from Baseline indicated improvement.|Baseline, Week 260|Participants from the Modified Intent-to-treat population, All Tocilizumab Exposure group, with data available at Baseline and Week 260. Last observation carried forward was used for missing joint counts.||Joint Count||Standard Deviation|Mean
705242|NCT00106535|Secondary|End of Study: Percentage of Participants With DAS28 European League Against Rheumatism (EULAR) Good or Moderate Response at Week 260|The DAS28 score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity (mm), and ESR. DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement. EULAR Good response: DAS28 ≤ 3.2 and a change from Baseline < -1.2. EULAR Moderate response: DAS28 >3.2 to ≤ 5.1 or a change from Baseline < -0.6 to ≥ -1.2.|Baseline, Week 260|Participants from the Modified Intent-to-treatment population, all exposure group, with data available at Week 260. Last observation carried forward was used for tender and swollen joint counts. No imputation used for ESR and Patients Global Assessment of Disease Activity VAS.||Percentage of participants|||Number
706432|NCT00115804|Secondary|Children's Depression Inventory|A 27-item, self-report measure of depressive symptoms with a score range of 0 (no depressive symptoms) to 54 (severe depressive symptoms.|Over the past 2 weeks.|||units on a scale||Standard Deviation|Mean
705243|NCT00106535|Secondary|End of Study: Percentage of Participants With DAS28 Low Disease Activity (LDA) at Week 260|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR). DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. LDA is defined as DAS28 ≤3.2.|Week 260|Participants from the Modified Intent-to-treatment population, all exposure group, with data available at Week 260. Last observation carried forward was used for tender and swollen joint counts. No imputation used for ESR and Patients Global Assessment of Disease Activity VAS.||Percentage of participants|||Number
705244|NCT00106535|Secondary|End of Study: Percentage of Participants With DAS28 Remission at Week 260|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR). DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score <2.6.|Week 260|Participants from the Modified Intent-to-treatment population, all exposure group, with data available at Week 260. Last observation carried forward was used for tender and swollen joint counts. No imputation used for ESR and Patients Global Assessment of Disease Activity VAS.||Percentage of participants|||Number
705245|NCT00106535|Secondary|End of Study: Percentage of Participants With ACR Response at Week 260|ACR20/50/70/90 response is defined as a ≥ 20/50/70/90% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.|Baseline, Week 260|Participants from the Modified Intent-to-treatment population, all exposure group, with data available at Baseline and Week 260. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments.||Percentage of participants|||Number
705246|NCT00106535|Secondary|Percentage of Participants Who Achieved Complete Clinical Response at Week 104|Complete clinical response is defined as a continuous 6-month period of remission by ACR criteria [defined as five of the following criteria are met for at least two consecutive months: morning stiffness < 15 minutes, no fatigue, no joint pain, no joint tenderness or swelling, and ESR < 30 mm/hr for a female or 20 mm/hr for a male] and no radiographic progression [defined as change from baseline ≤ 0 in the total Sharp-Genant score, erosion score, and JSN score].|104 Weeks|Intent-to-treat population included all randomized participants who received at least 1 dose of study drug. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who received escape therapy, withdrew or where an ACR could not be calculated, were set to 'Non Responder'.||Percentage of participants|||Number
705247|NCT00106535|Secondary|Percentage of Participants Who Achieved Complete Clinical Response at Week 52|Complete clinical response is defined as a continuous 6-month period of remission by ACR criteria [defined as five of the following criteria are met for at least two consecutive months: morning stiffness < 15 minutes, no fatigue, no joint pain, no joint tenderness or swelling, and ESR < 30 mm/hr for a female or 20 mm/hr for a male] and no radiographic progression [defined as change from baseline ≤ 0 in the total Sharp-Genant score, erosion score, and JSN score]. Patients who achieve a complete clinical response at any time in the study are counted as responders, even if the response is not maintained.|52 Weeks|Intent-to-treat population included all randomized participants who received at least 1 dose of study drug. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who received escape therapy, withdrew or where an ACR could not be calculated, were set to ’Non Responder’.||Percentage of participants|||Number
705248|NCT00106535|Secondary|Percentage of Participants Who Achieved Remission According to the ACR Remission Criteria by Week 104|The percentage of participants who achieved ACR remission at any study visit up to Week 104. ACR remission required that all five of the following criteria were met for at least two consecutive months: morning stiffness < 15 minutes, no fatigue, no joint pain, no joint tenderness or pain on motion, no soft tissue swelling in joints or tendon sheaths, and ESR < 30 mm/hr for a female or 20 mm/hr for a male.|104 Weeks|Intent-to-treat population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for morning stiffness, FACIT-Fatigue score, ESR and VAS assessment. Patients with missing data, early withdrawal or who received escape therapy were set to 'Non Responder'.||Percentage of participants|||Number
705249|NCT00106535|Secondary|Percentage of Participants Who Achieved Remission According to the ACR Remission Criteria by Week 52|The percentage of participants, who achieved ACR remission at any study visit up to Week 52. ACR remission required that all five of the following criteria were met for at least two consecutive months: morning stiffness < 15 minutes, no fatigue, no joint pain, no joint tenderness or pain on motion, no soft tissue swelling in joints or tendon sheaths, and ESR < 30 mm/hr for a female or 20 mm/hr for a male.|52 Weeks|Intent-to-treat population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for morning stiffness, FACIT-Fatigue score, ESR and VAS assessment. Patients with missing data, early withdrawal or who received escape therapy were set to 'Non Responder'.||Percentage of participants|||Number
705350|NCT00106639|Secondary|Number of Participants With Hypertriglyceridemia|Hypertriglyceridemia was defined as a value of triglycerides greater than 200 mg/dL.|Baseline, Day 14, Month 1, 3, 6|Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies those participants evaluable at specific time points for each group respectively.||participants|||Number
705250|NCT00106535|Secondary|Percentage of Participants Who Achieved Remission According to the ACR Remission Criteria by Week 24|The percentage of participants, who achieved ACR remission at any study visit up to Week 24. ACR remission required that all five of the following criteria were met for at least two consecutive months: morning stiffness < 15 minutes, no fatigue, no joint pain, no joint tenderness or pain on motion, no soft tissue swelling in joints or tendon sheaths, and ESR < 30 mm/hr for a female or 20 mm/hr for a male.|24 Weeks|Intent-to-treat population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for morning stiffness, FACIT-Fatigue score, ESR and VAS assessment. Patients with missing data, early withdrawal or who received escape therapy were set to ’Non Responder’.||Percentage of participants|||Number
705251|NCT00106535|Secondary|Percentage of Participants in Each Treatment Group Who Receive Escape Therapy|"In Escape 1, participants in the Tocilizumab 4 mg/kg + Methotrexate and Tocilizumab 8 mg/kg + Methotrexate groups received tocilizumab 8 mg/kg as escape therapy. Participants in the Placebo + Methotrexate group received tocilizumab 4 mg/kg as escape therapy.
In Escape 2, all participants received tocilizumab 8 mg/kg."|104 Weeks|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis.||Percentage of participants|||Number
705252|NCT00106535|Secondary|Percentage of Participants Who Withdraw Due to Lack of Sufficient Therapeutic Response|Insufficient therapeutic response (patient not responding to the drug as assessed by the physician) was selected by the investigator as a reason that the patient withdrew from the study.|104 Weeks|Intent-to-treat population included all randomized participants who received at least 1 dose of study drug. Data on escape therapy is excluded.||Percentage of participants|||Number
705253|NCT00106535|Secondary|Time to Onset of ACR70 by Treatment Group|Time in days until ACR70 response. ACR70 response is defined as a ≥ 70% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient’s Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient’s Global Assessment of Disease Activity and Physician’s Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.|6 months|Participants from the ITT population [N=393,399,398] (all randomized participants who received study drug) with ACR70 response. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who withdrew, received escape therapy or who did not achieve a response were censored.||Days||95% Confidence Interval|Median
705254|NCT00106535|Secondary|Time to Onset of ACR50 by Treatment Group|Time in days until ACR50 response. ACR50 response was defined as a ≥ 50% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient’s Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient’s Global Assessment of Disease Activity and Physician’s Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.|6 months|Participants from the ITT population [N=393,399,398] (all randomized participants who received study drug) with ACR50 response. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who withdrew, received escape therapy or who did not achieve a response were censored.||Days||95% Confidence Interval|Median
705255|NCT00106535|Secondary|Time to Onset of ACR20 by Treatment Group|Time in days until ACR20 response. ACR20 response was defined as a ≥ 20% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient’s Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient’s Global Assessment of Disease Activity and Physician’s Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.|6 months|Participants from the ITT population [N=393,399,398] (all randomized participants who received study drug) with ACR20 response. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who withdrew, received escape therapy or who did not achieve a response were censored.||Days||95% Confidence Interval|Median
705256|NCT00106535|Secondary|Change From Baseline in Rheumatoid Factor (RF) at Week 104 in Those Patients With Positive RF|Blood was collected for Rheumatoid Factor (RF) at Baseline and Week 104 and was analyzed at a central laboratory. RF level was reported in international units/milliliter (IU/mL). A positive RF= >15 IU/mL. A lower number change from Baseline indicated a better result.|Baseline, Week 104|Participants from the Intent-to-treat population (all randomized participants who received at least one dose of study drug) with positive RF at Baseline. No imputation was used for missing data. All assessments were set to missing from the time a patient received escape therapy.||IU/mL||Standard Deviation|Mean
705257|NCT00106535|Secondary|Change From Baseline in Rheumatoid Factor (RF) at Week 52 in Those Patients With Positive RF|Blood was collected for Rheumatoid Factor (RF) at Baseline and Week 52 and was analyzed at a central laboratory. RF level was reported in international units/milliliter (IU/mL). A positive RF= >15 IU/mL. A lower number change from Baseline indicated a better result.|Baseline, Week 52|Participants from the Intent-to-treat population (all randomized participants who received at least one dose of study drug) with positive RF at Baseline. No imputation was used for missing data. All assessments were set to missing from the time a patient received escape therapy.||IU/mL||Standard Deviation|Mean
705258|NCT00106535|Secondary|Change From Baseline in Rheumatoid Factor (RF) at Week 24 in Those Patients With Positive RF|Blood was collected for Rheumatoid Factor (RF) at Baseline and Week 24 and was analyzed at a central laboratory. RF level was reported in international units/milliliter (IU/mL). A positive RF= >15 IU/mL. A lower number change from Baseline indicated a better result.|Baseline, Week 24|Participants from the Intent-to-treat population (all randomized participants who received at least one dose of study drug) with positive RF at Baseline. No imputation was used for missing data. All assessments were set to missing from the time a patient received escape therapy.||IU/mL||Standard Deviation|Mean
705259|NCT00106535|Secondary|Change From Baseline in FACIT-F Score at Week 104|FACIT-F is a 13-item questionnaire. Patients scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the patient's response to the questions (with the exception of 2 negatively stated), the greater the patient's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the patient's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the patient's health status.|Baseline, Week 104|Participants from the Intent-to-treat population (all randomized participants who received at least one dose of study drug) with data available for analysis. No imputation was used for missing data. All assessments were set to missing from the time a patient received escape therapy.||Score on a scale||Standard Deviation|Mean
705260|NCT00106535|Secondary|Change From Baseline in FACIT-F Score at Week 52|FACIT-F is a 13-item questionnaire. Patients scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the patient's response to the questions (with the exception of 2 negatively stated), the greater the patient's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the patient's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the patient's health status.|Baseline, Week 52|Participants from the Intent-to-treat population (all randomized participants who received at least one dose of study drug) with data available for analysis. No imputation was used for missing data. All assessments were set to missing from the time a patient received escape therapy.||Score on a scale||Standard Deviation|Mean
705261|NCT00106535|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Score at Week 24|FACIT-F is a 13-item questionnaire. Patients scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the patient's response to the questions (with the exception of 2 negatively stated), the greater the patient's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the patient's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the patient's health status.|Baseline, Week 24|Participants from the Intent-to-treat population (all randomized participants who received at least one dose of study drug) with data available for analysis. No imputation was used for missing FACIT-Fatigue scores. All assessments were set to missing from the time a patient received escape therapy.||Score on a scale||Standard Deviation|Mean
705262|NCT00106535|Secondary|Change From Baseline in SF-36 Score at Week 104|The SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from Baseline indicated improvement.|Baseline, Week 104|Participants from the Intent-to-treat population (all participants who received at least one dose of study drug) with data available for analysis. No imputation was used for missing data. All assessments were set to missing from the time a patient received escape therapy.||Score on a scale||Standard Deviation|Mean
705263|NCT00106535|Secondary|Change From Baseline in SF-36 Score at Week 52|The SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from Baseline indicates improvement.|Baseline, Week 52|Participants from the Intent-to-treat population (all participants who received at least one dose of study drug) with data available for analysis. No imputation was used for missing data. Data was set to missing for patients who received escape therapy.||Score on a scale||Standard Deviation|Mean
705264|NCT00106535|Secondary|Change From Baseline in Quality Life Short Form-36 (SF-36) Score at Week 24|The SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from baseline indicates improvement.|Baseline, Week 24|Participants from the Intent-to-treat population (all participants who received at least one dose of study drug) with data available for analysis. No imputation was used for missing data. . Data was set to missing for patients who received escape therapy.||Score on a scale||Standard Deviation|Mean
705265|NCT00106535|Secondary|Change From Baseline in HAQ Disability Index at Week 104|HAQ-DI is a self-completed questionnaire specific for RA. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities. Each domain has at least 2 component questions. There are 4 possible responses for each component 0=without any difficulty 1=with some difficulty 2=with much difficulty 3=unable to do. To Calculate HAQ-DI the patient must have a domain score for at least 6 of 8 domains. The HAQ-DI is the sum of the scores, divided by the number of domains that have a score (in range 6-8). Total possible score minimum/maximum 0 (best) to 3 (worst). A negative change from Baseline indicated improvement.|Baseline, Week 104|Participants from the Intent-to-treat population (all participants who received at least one dose of study drug) with data available for analysis. No imputation was used for missing data. All assessments were set to missing from the time a patient received escape therapy.||Score on a scale||Standard Deviation|Mean
705266|NCT00106535|Secondary|Change From Baseline in HAQ Disability Index (HAQ-DI) at Week 52|HAQ-DI is a self-completed questionnaire specific for RA. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities. Each domain has at least 2 component questions. There are 4 possible responses for each component 0=without any difficulty 1=with some difficulty 2=with much difficulty 3=unable to do. To Calculate HAQ-DI the patient must have a domain score for at least 6 of 8 domains. The HAQ-DI is the sum of the scores, divided by the number of domains that have a score (in range 6-8) for a total possible score minimum/maximum 0 (best) to 3 (worst). A negative change from baseline indicated improvement.|Baseline, Week 52|Participants from the Intent-to-treat population (all participants who received at least one dose of study drug) with data available for analysis. No imputation was used for missing data. All assessments were set to missing from the time a patient received escape therapy.||Score on a scale||Standard Deviation|Mean
705267|NCT00106535|Secondary|Percentage of Participants With no Progression of Joint Space Narrowing at Week 104|Radiographs were taken of a total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint) for a total possible score of 0 (best) to 148 (worst). No progression of Joint Space Narrowing score is defined as a change from Baseline of less than or equal to zero.|Baseline, Week 104|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Missing data was imputed using linear extrapolation. Data collected after withdrawal or on escape therapy was excluded.||Percentage of participants|||Number
705268|NCT00106535|Secondary|Percentage of Participants With no Progression of Joint Space Narrowing at Week 52|Radiographs were taken of a total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint) for a total possible score of 0 (best) to 148 (worst). No progression of Joint Space Narrowing score is defined as a change from Baseline of less than or equal to zero.|Baseline, Week 52|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Missing data was imputed using linear extrapolation. Data collected after withdrawal or on escape therapy was excluded.||Percentage of participants|||Number
705269|NCT00106535|Secondary|Percentage of Participants With no Progression of Joint Space Narrowing at Week 24|Radiographs were taken of a total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint) for a total possible score of 0 (best) to 148 (worst). No progression of Joint Space Narrowing score was defined as a change from Baseline of less than or equal to zero.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Data collected after withdrawal or on escape therapy was excluded.||Percentage of participants|||Number
705270|NCT00106535|Secondary|Percentage of Participants With no Progression of Erosion at Week 104|Radiographs were taken of a total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion for a total possible score of 0 (best) to 142 (worst). No progression of Erosion score was defined as a change from Baseline of less than or equal to zero.|Baseline, Week 104|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Missing data was imputed using linear extrapolation. Data collected after withdrawal or on escape therapy was excluded.||Percentage of participants|||Number
705271|NCT00106535|Secondary|Percentage of Participants With no Progression of Erosion at Week 52|Radiographs were taken of a total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion for a total possible score of 0 (best) to 142 (worst). No progression of Erosion score was defined as a change from Baseline of less than or equal to zero.|Baseline, Week 52|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Missing data was imputed using linear extrapolation. Data collected after withdraw or on escape therapy was excluded.||Percentage of participants|||Number
705272|NCT00106535|Secondary|Percentage of Participants With no Progression of Erosion at Week 24|Radiographs were taken of a total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion for a total possible score of 0 (best) to 142 (worst). No progression of Erosion score was defined as a change from Baseline of less than or equal to zero.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Data collected after withdraw or on escape therapy was excluded.||Percentage of participants|||Number
705273|NCT00106535|Secondary|Change From Baseline in Joint Space Narrowing Score at Week 104|Radiographs were taken of a total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint) for a total possible score of 0 (best) to 148 (worst). A lower number change from Baseline indicated a better score.|Baseline, Week 104|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Missing data was imputed using linear extrapolation. Data collected after withdraw or on escape therapy was excluded.||Score on a scale||Standard Deviation|Mean
705305|NCT00106535|Secondary|Change From Baseline in Tender Joint Count at Week 104|68 joints were assessed for tenderness and joints were classified as tender/not tender for a total possible tender joint count of 0 (best) to 68 (worst). A negative change from Baseline indicated improvement.|Baseline, Week 104|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF was used for tender joint counts. All assessments were set to missing from the time a patient received escape therapy and only pre-escape therapy joint count assessments were carried forward.||Joint count||Standard Deviation|Mean
705274|NCT00106535|Secondary|Change From Baseline in Joint Space Narrowing Score at Week 80|Radiographs were taken of a total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint) for a total possible score of 0 (best) to 148 (worst). A lower number change from Baseline indicated a better score.|Baseline, Week 80|Participants from the Intent-to-treat population (all randomized participants who received at least one dose of study drug) with Baseline and post-Baseline radiographic data available for this outcome measure. Missing data was imputed using linear extrapolation. Data collected after withdraw or on escape therapy was excluded.||Score on a scale||Standard Deviation|Mean
705275|NCT00106535|Secondary|Change From Baseline in Joint Space Narrowing Score at Week 52|Radiographs were taken of a total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint) for a total possible score of 0 (best) to 148 (worst). A lower number change from Baseline indicated a better score.|Baseline, Week 52|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Missing data was imputed using linear extrapolation. Data collected after withdraw or on escape therapy was excluded.||Score on a scale||Standard Deviation|Mean
705276|NCT00106535|Secondary|Change From Baseline in Joint Space Narrowing Score at Week 24|Radiographs were taken of a total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint) for a total possible score of 0 (best) to 148 (worst). A lower change from Baseline indicated a better score.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Data was set to missing for patients who withdrew or received escape therapy.||Score on a scale||Standard Deviation|Mean
705277|NCT00106535|Secondary|Change From Baseline in Erosion Score at Week 104|Radiographs were taken of a total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion for a total possible score of 0 (best) to 142 (worst). A lower number change from Baseline indicated a better score.|Baseline, Week 104|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Linear extrapolation was used to impute missing data. Data collected after withdraw or on escape therapy is excluded.||Score on a scale||Standard Deviation|Mean
705278|NCT00106535|Secondary|Change From Baseline in Erosion Score at Week 80|Radiographs were taken of a total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion for a total possible score of 0 (best) to 142 (worst). A lower number change from Baseline indicated a better score.|Baseline, Week 80|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Linear extrapolation was used to impute missing data. Data collected after withdraw or on escape therapy is excluded.||Score on a scale||Standard Deviation|Mean
705279|NCT00106535|Secondary|Change From Baseline in Erosion Score at Week 52|Radiographs were taken of a total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion for a total possible score of 0 (best) to 142 (worst). A lower number change from Baseline indicated a better score.|Baseline, Week 52|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data for this outcome measure. Missing Week 52 data was imputed using Linear extrapolation. Data was set to missing for patients who withdrew or received escape therapy.||Score on a scale||Standard Deviation|Mean
705280|NCT00106535|Secondary|Change From Baseline in Erosion Score at Week 24|Radiographs were taken of a total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion for a total possible score of 0 (best) to 142 (worst). A lower number change from Baseline indicated a better score.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Data was set to missing for patients who withdrew or received escape therapy.||Score on a scale||Standard Deviation|Mean
705281|NCT00106535|Secondary|Change From Baseline in Modified Total Sharp-Genant Score at Week 80|Radiographs were taken of each hand and foot at Baseline and Week 80 and evaluated at a central reading service by two independent radiologists using the Genant modified method according to Sharp. Erosion Score: A total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion. Joint Narrowing Score: A total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint). The maximum total erosion score in the hands is 100 and in the feet 42, the maximum scores for joint space narrowing in the hands is 100 and in the feet 48. The maximum modified Sharp score achievable is 290. A lower number change from Baseline indicated a better score.|Baseline, Week 80|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Linear extrapolation was used to impute missing data. Data collected after withdraw or on escape therapy is excluded.||Score on a scale||Standard Deviation|Mean
705304|NCT00106535|Secondary|Change From Baseline in Patient's Global Assessment of Disease Activity at Week 104|"The patient's global assessment of disease activity was assessed at Baseline and Week 104 using a 0 to 100 mm horizontal visual analogue scale (VAS) by the patient. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). A negative change from Baseline indicated improvement."|Baseline, Week 104|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. No imputation was used for missing VAS assessments. All assessments were set to missing from the time a patient received escape therapy||Score on a scale||Standard Deviation|Mean
705282|NCT00106535|Secondary|Change From Baseline in Modified Total Sharp-Genant Score at Week 24|Radiographs were taken of each hand and foot at Baseline and Week 24 and evaluated at a central reading service by two independent radiologists using the Genant modified method according to Sharp. Erosion Score: A total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion. Joint Narrowing Score: A total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint). The maximum total erosion score in the hands is 100 and in the feet 42, the maximum scores for joint space narrowing in the hands is 100 and in the feet 48. The maximum modified Sharp score achievable is 290. A lower number change from Baseline indicated a better score.|Baseline, Week 24|Participants from the Intent-to-treat population (all randomized participants who received at least one dose of study drug) with Baseline and post-Baseline radiographic data available for this outcome measure. Data collected after withdraw or on escape therapy is excluded.||Score on a scale||Standard Deviation|Mean
705283|NCT00106535|Secondary|Area Under Curve (AUC) of Disease Activity Score (DAS28) at Week 104|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR). DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. Higher calculated AUC values are worse (indicate higher disease activity).|104 Weeks|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF was used for tender and swollen joint counts, no imputation used for missing ESR and VAS assessments. All assessments were set to missing from the time a patient received escape therapy.||Score on a scale*week||Standard Deviation|Mean
705284|NCT00106535|Secondary|Area Under Curve (AUC) of Disease Activity Score (DAS28) at Week 52|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR). DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. Higher calculated AUC values are worse (indicate higher disease activity).|52 Weeks|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF was used for tender and swollen joint counts, no imputation used for missing ESR and VAS assessments. All assessments were set to missing from the time a patient received escape therapy.||Score on a scale*week||Standard Deviation|Mean
705285|NCT00106535|Secondary|Area Under Curve (AUC) of Disease Activity Score (DAS28) at Week 24|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR). DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. Higher calculated AUC values are worse (indicate higher disease activity).|24 Weeks|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF used for tender and swollen joint counts, no imputation used for missing ESR and VAS assessments. All assessments were set to missing from the time a patient received escape therapy.||Score on a scale*week||Standard Deviation|Mean
705286|NCT00106535|Secondary|Percentage of Participants With DAS28 Remission at Week 104|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR). DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score <2.6.|Week 104|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF was used for tender and swollen joint counts, no imputation used for missing ESR and VAS assessments. All assessments were set to missing from the time a patient received escape therapy.||Percentage of participants|||Number
705287|NCT00106535|Secondary|Percentage of Participants With DAS28 Remission at Week 52|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR). DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control.DAS28 Remission is defined as a DAS28 score <2.6.|Week 52|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF was used for tender and swollen joint counts, no imputation used for missing ESR and VAS assessments. All assessments were set to missing from the time a patient received escape therapy.||Percentage of participants|||Number
705288|NCT00106535|Secondary|Percentage of Participants With DAS28 Remission at Week 24|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR). DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 remission is defined as a DAS28 score <2.6.|Week 24|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF was used for tender and swollen joint counts, no imputation used for missing ESR and VAS assessments. All assessments were set to missing from the time a patient received escape therapy.||Percentage of participants|||Number
705376|NCT00106639|Secondary|Number of Participants With Treatment Failure|Treatment failure was defined as the first occurrence of BPAR, graft loss, participant’s death or premature discontinuation of study medication for any reason.|Month 3, 6|FAS included all randomized participants who received at least 1 dose of study medication.||participants|||Number
705289|NCT00106535|Secondary|Percentage of Participants With DAS28 Good or Moderate EULAR Response at Week 104|"The DAS28 score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity (mm) [visual analog scale: 0=no disease activity to 100=maximum disease activity] , and ESR. DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement.
European League Against Rheumatism (EULAR) Good response: DAS28 ≤ 3.2 and a change from Baseline < -1.2.
EULAR Moderate response: DAS28 >3.2 to ≤ 5.1 or a change from Baseline < -0.6 to ≥ -1.2."|Baseline, Week 104|ITT population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation was used for missing ESR and VAS assessments. For patients who received escape therapy, withdrew prematurely or where the DAS28 score was missing the response was set to 'No response'.||Percentage of participants|||Number
705290|NCT00106535|Secondary|Percentage of Participants With DAS28 Good or Moderate EULAR Response at Week 52|"The DAS28 score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity (mm) [visual analog scale: 0=no disease activity to 100=maximum disease activity] , and ESR. DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement.
European League Against Rheumatism (EULAR) Good response: DAS28 ≤ 3.2 and a change from Baseline < -1.2.
EULAR Moderate response: DAS28 >3.2 to ≤ 5.1 or a change from Baseline < -0.6 to ≥ -1.2."|Baseline, Week 52|ITT population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for missing ESR and VAS assessments. For patients who received escape therapy, withdrew prematurely or where the DAS28 score was missing the response was set to 'No response'.||Percentage of participants|||Number
705291|NCT00106535|Secondary|Percentage of Participants With DAS28 Good or Moderate EULAR Response at Week 24|"The DAS28 score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] , and ESR. DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement.
European League Against Rheumatism (EULAR) Good response: DAS28 ≤ 3.2 and a change from Baseline < -1.2.
EULAR Moderate response: DAS28 >3.2 to ≤ 5.1 or a change from Baseline < -0.6 to ≥ -1.2."|Baseline, Week 24|ITT population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for missing ESR and VAS assessments. For patients who received escape therapy, withdrew prematurely or where the DAS28 score was missing the response was set to 'No response'.||Percentage of participants|||Number
705292|NCT00106535|Secondary|Change From Baseline in Disease Activity Score (DAS28) at Week 104|The DAS28 score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity], and ESR. DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement.|Baseline, Week 104|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF used for tender and swollen joint counts, no imputation used for missing ESR and VAS assessments. All assessments were set to missing from the time a patient received escape therapy.||Score on a scale||Standard Deviation|Mean
705293|NCT00106535|Secondary|Change From Baseline in Disease Activity Score (DAS28) at Week 52|The DAS28 score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity], and ESR. DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement.|Baseline, Week 52|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF was used for tender and swollen joint counts, no imputation used for missing ESR and VAS assessments. All assessments were set to missing from the time a patient received escape therapy.||Score on a scale||Standard Deviation|Mean
705294|NCT00106535|Secondary|Change From Baseline in Disease Activity Score (DAS28) at Week 24|The DAS28 score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity], and ESR. DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement.|Baseline, Week 24|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF was used for tender and swollen joint counts, no imputation used for missing ESR and VAS assessments. All assessments were set to missing from the time a patient received escape therapy.||Score on a scale||Standard Deviation|Mean
705295|NCT00106535|Secondary|Area Under Curve (AUC) of the ACRn Score at Week 104|The ACRn is defined as each patient’s lowest percent improvement from Baseline of 3 measures: tender joint count (68 joints), swollen joint count (66 joints), and the improved score achieved in at least 3 of the 5 remaining ACR core components (physician global assessment, patient global assessment, pain, HAQ, and C-reactive protein or ESR, respectively). AUC of ACRn, a continuous variable, was calculated from Baseline to Week 104. A positive score change from Baseline indicated an improvement. The higher the ACRn score the better.|104 Weeks|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ score, CRP, ESR and VAS assessments. All assessments were set to missing from the time a patient received escape therapy.||Score on a scale*week||Standard Deviation|Mean
705401|NCT00106938|Secondary|Freedom From Ipsilateral Stroke|Ipsilateral stroke was defined as stroke in the vascular distribution of the study carotid artery. If a subject experienced a bilateral stroke it was counted as an ipsilateral stroke for analysis purposes.|31 to 730 days|||percentage of participants|||Number
705296|NCT00106535|Secondary|Area Under Curve (AUC) of the ACRn to Week 52|The ACRn is defined as each patient’s lowest percent improvement from Baseline of 3 measures: tender joint count (68 joints), swollen joint count (66 joints), and the improved score achieved in at least 3 of the 5 remaining ACR core components (physician global assessment, patient global assessment, pain, HAQ, and C-reactive protein or ESR, respectively). AUC of ACRn, a continuous variable, was calculated from Baseline to Week 52. A positive score change from Baseline indicated an improvement. The higher the ACRn score the better.|52 Weeks|Participants from the Intent-to-treat population(all randomized participants who received study drug) with data available for analysis. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ score, CRP, ESR and VAS assessments. All assessments were set to missing from the time a patient received escape therapy.||Score on a scale*week||Full Range|Least Squares Mean
705297|NCT00106535|Secondary|Area Under Curve (AUC) of the ACRn to Week 24|The ACRn is defined as each patient’s lowest percent improvement from Baseline of 3 measures: tender joint count (68 joints), swollen joint count (66 joints), and the improved score achieved in at least 3 of the 5 remaining ACR core components (physician global assessment, patient global assessment, pain, HAQ, and C-reactive protein or ESR, respectively). AUC of ACRn, a continuous variable, was calculated from Baseline to Week 24. A positive score change from Baseline indicated an improvement. The higher the ACRn score the better.|24 Weeks|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ score, CRP, ESR and VAS assessments. All assessments were set to missing from the time a patient received escape therapy.||Score on a scale*week||Standard Deviation|Mean
705298|NCT00106535|Secondary|Percentage of Participants Who Achieve an Improvement of at Least 0.3 Units From Baseline in the HAQ Disability Index at Week 104|The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0 (without any difficulty) to 3 (unable to do).HAQ-DI=sum of worst scores in each domain divided by the number of domains answered for a total possible score of 0 (best) to 3 (worst).|Baseline, Week 104|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. No imputation was used for missing data. All assessments were set to missing from the time a patient received escape therapy.||Percentage of participants|||Number
705299|NCT00106535|Secondary|Percentage of Participants Who Achieve an Improvement of at Least 0.3 Units From Baseline in the HAQ Disability Index at Week 52|The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0 (without any difficulty) to 3 (unable to do). HAQ-DI=sum of worst scores in each domain divided by the number of domains answered for a total possible score of 0 (best) to 3 (worst).|Baseline, Week 52|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. No imputation was used for missing data. All assessments were set to missing for patients who received escape therapy.||Percentage of participants|||Number
705300|NCT00106535|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 104|Blood was collected for Erythrocyte Sedimentation Rate (ESR) at Baseline and Week 104 and was analyzed at a local laboratory. ESR was measured in millimeters/hour (mm/hr). A reduction in the level is considered an improvement.|Baseline, Week 104|Participants from the Intent-to-treat population (all randomized participants who received at least one dose of study drug) with data available for analysis. No imputation was used for missing data. All assessments were set to missing from the time a patient received escape therapy.||mm/hr||Standard Deviation|Mean
705301|NCT00106535|Secondary|Change From Baseline in C-Reactive Protein (CRP) at Week 104|Blood was collected for C-Reactive Protein (CRP) at Baseline and Week 104 and was analyzed at a central laboratory. The serum concentration of CRP was measured in milligrams/deciliter (mg/dL). A reduction in the level is considered an improvement.|Baseline, Week 104|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. No imputation was used for missing data. All assessments were set to missing from the time a patient received escape therapy.||mg/dL||Standard Deviation|Mean
705302|NCT00106535|Secondary|Change From Baseline in the Patient's Pain VAS at Week 104|"The patient assessed their pain at Baseline and Week 104 using a 0 to 100 millimeter (mm) horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 mm, and is described as no pain and the right-hand extreme equals 100 mm as unbearable pain. A negative change from Baseline indicated improvement."|Baseline, Week 104|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. No imputation was used for missing VAS assessments. All assessments were set to missing from the time a patient received escape therapy.||Score on a scale||Standard Deviation|Mean
705303|NCT00106535|Secondary|Change From Baseline in Physicians Global Assessment of Disease Activity at Week 104|"The physician's global assessment of disease activity was assessed at Baseline and Week 104 using a 0 to 100 mm horizontal visual analogue scale (VAS) by the physician. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). A negative change from Baseline indicated improvement."|Baseline, Week 104|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. No imputation was used for missing VAS assessments. All assessments were set to missing from the time a patient received escape therapy.||Score on a scale||Standard Deviation|Mean
705346|NCT00106639|Secondary|BK Virus (BKV) Deoxyribonucleic Acid (DNA) Load||Baseline, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.||Copies/20 mcL plasma||Standard Deviation|Mean
705306|NCT00106535|Secondary|Change From Baseline in Swollen Joint Count at Week 104|66 joints were assessed at Baseline and Week 104 for swelling and joints were classified as swollen/not swollen for a total possible swollen joint count of 0 (best) to 66 (worst). A negative change from Baseline indicated improvement.|Baseline, Week 104|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF was used for swollen joint counts. All assessments were set to missing from the time a patient received escape therapy and only pre-escape therapy joint count assessments were carried forward.||Joint count||Standard Deviation|Mean
705307|NCT00106535|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 52|Blood was collected for Erythrocyte Sedimentation Rate (ESR) at Baseline and Week 52 and was analyzed at a local laboratory. ESR was measured in millimeters/hour (mm/hr). A reduction in the level is considered an improvement.|Baseline, Week 52|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. No imputation was used for missing data. Data was set to missing for patients who received escape therapy.||mm/hr||Standard Deviation|Mean
705308|NCT00106535|Secondary|Change From Baseline in C-Reactive Protein (CRP) at Week 52|Blood was collected for C-Reactive Protein (CRP) at Baseline and Week 52 and was analyzed at a central laboratory. The serum concentration of CRP was measured in milligrams/deciliter (mg/dL). A reduction in the level is considered an improvement.|Baseline, Week 52|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. No imputation was made for missing data. All assessments were set to missing from the time a patient received escape therapy.||mg/dL||Standard Deviation|Mean
705309|NCT00106535|Secondary|Change From Baseline in the Patient's Pain VAS at Week 52|The patient assessed their pain at Baseline and Week 52 using a 0 to 100 millimeter (mm) horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 mm, and is described as “no pain” and the right-hand extreme equals 100 mm as “unbearable pain”. A negative change from Baseline indicated improvement.|Baseline, Week 52|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. No imputation was used for missing VAS assessments. Data was set to missing for patients who received escape therapy.||Score on a scale||Standard Deviation|Mean
705310|NCT00106535|Secondary|Change From Baseline in Physicians Global Assessment of Disease Activity at Week 52|The physician’s global assessment of disease activity was assessed using a 0 to 100 mm horizontal visual analogue scale (VAS) by the physician. The left-hand extreme of the line equals 0 mm, and is described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as “maximum disease activity” (maximum arthritis disease activity). A negative change from Baseline indicated improvement.|Baseline, Week 52|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. No imputation was used for missing VAS assessments. All assessments were set to missing after the patient received escape therapy.||Score on a scale||Standard Deviation|Mean
705311|NCT00106535|Secondary|Change From Baseline in Patient's Global Assessment of Disease Activity at Week 52|The patient’s global assessment of disease activity is assessed at Baseline and Week 52 using a 0 to 100 mm horizontal visual analogue scale (VAS) by the patient. The left-hand extreme of the line equals 0 mm, and is described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as “maximum disease activity” (maximum arthritis disease activity). A negative change from Baseline indicated improvement.|Baseline, Week 52|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. No imputation was used for missing VAS assessments. All assessments were set to missing from the time a patient received escape therapy.||Score on a scale||Standard Deviation|Mean
705312|NCT00106535|Secondary|Change From Baseline in Tender Joint Count at Week 52|68 joints were assessed at Baseline and Week 52 for tenderness and joints were classified as tender/not tender for a total possible tender joint count of 0 (best) to 68 (worst). A negative change from Baseline indicated improvement.|Baseline, Week 52|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF was used for missing tender joint data. All assessments were set to missing from the time a patient received escape therapy and only pre-escape therapy joint count assessments were carried forward.||Joint count||Standard Deviation|Mean
705313|NCT00106535|Secondary|Change From Baseline in Swollen Joint Count at Week 52|66 joints were assessed at Baseline and Week 52 for swelling and joints are classified as swollen/not swollen for a total possible swollen joint count of 0 (best) to 66 (worst). A negative change from Baseline indicated improvement.|Baseline, Week 52|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF was used for swollen joint counts. All assessments were set to missing from the time a patient received escape therapy and only pre-escape therapy joint count assessments were carried forward.||Joint count||Standard Deviation|Mean
705314|NCT00106535|Secondary|Percentage of Participants With ACR70 Response Maintained for 6 Consecutive Months|ACR70 response is defined as a ≥ 70% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.|104 Weeks|Intent-to-treat population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who received escape therapy, withdrew prematurely or where an ACR could not be calculated, were set to 'Non Responder'.||Percentage of participants|||Number
705402|NCT00106938|Secondary|Freedom From Ipsilateral Stroke|Ipsilateral stroke was defined as stroke in the vascular distribution of the study carotid artery. If a subject experienced a bilateral stroke it was counted as an ipsilateral stroke for analysis purposes.|31 to 365 days|||percentage of participants|||Number
705315|NCT00106535|Secondary|Percentage of Participants With ACR70 Response at Week 104|ACR50 response is defined as a ≥ 70% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.|Baseline, Week 104|Intent-to-treat population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who received escape therapy, withdrew prematurely or where an ACR could not be calculated, were set to 'Non Responder'.||Percentage of participants|||Number
705316|NCT00106535|Secondary|Percentage of Participants With ACR70 Response at Week 52|ACR70 response is defined as a ≥ 70% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.|Baseline, Week 52|Intent-to-treat population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who received escape therapy, withdrew prematurely or where an ACR could not be calculated, were set to 'Non Responder'.||Percentage of participants|||Number
705317|NCT00106535|Secondary|Percentage of Participants With ACR50 Response at Week 104|ACR50 response is defined as a ≥ 50% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.|Baseline, Week 104|Intent-to-treat population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who received escape therapy, withdrew prematurely or where an ACR could not be calculated, were set to 'Non Responder'.||Percentage of participants|||Number
705318|NCT00106535|Secondary|Percentage of Participants With ACR50 Response at Week 52|ACR50 response is defined as a ≥ 50% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.|Baseline, Week 52|Intent-to-treat population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who received escape therapy, withdrew prematurely or where an ACR could not be calculated, were set to 'Non Responder'.||Percentage of participants|||Number
705319|NCT00106535|Secondary|Percentage of Participants With ACR20 Response at Week 104|ACR20 response is defined as a ≥ 20% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.|Baseline, Week 104|Intent-to-treat population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who received escape therapy, withdrew prematurely or where an ACR could not be calculated, were set to 'Non Responder'.||Percentage of participants|||Number
705347|NCT00106639|Secondary|Epstein Barr Virus (EBV) and Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) Load||Baseline, Month 1, 3, 6 for CMV; Baseline, Day 14, Month 1, 3, 6 for EBV|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.||Copies/500 ng DNA||Standard Deviation|Mean
705403|NCT00106938|Secondary|Freedom From Clinically Indicated Target Lesion Revascularization|Freedom from CITLR was defined as freedom from reintervention for ≥ 50% restenosis in recently symptomatic patients and ≥ 80% restenosis in asymptomatic patients.|0 to 1825 days|||percentage of partcipants|||Number
705320|NCT00106535|Secondary|Percentage of Participants With American College of Rheumatology (ACR20) Response at Week 52|ACR20 response is defined as a ≥ 20% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient’s Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient’s Global Assessment of Disease Activity and Physician’s Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.|Baseline, Week 52|Intent-to-treat population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who received escape therapy, withdrew prematurely or where an ACR could not be calculated, were set to 'Non Responder'.||Percentage of participants|||Number
705321|NCT00106535|Primary|Change in Physical Function as Measured by the Area Under the Curve for the Change From Baseline in the Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 104|HAQ-DI consisted of 20 questions in 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities rated on a 4-point scale where 0=without any difficulty to 3=unable to do. The sum of scores was divided by the number of domains with a score for a total possible score of 0 (best) to 3 (worst). Functional disability was determined as a cumulative measure of HAQ-DI over 2 years by using the AUC of the change from baseline in HAQ-DI score through week 104. Decreases in AUC of change from baseline in HAQ-DI indicated a gr eater average improvement in physical function over time and represent a decrease in sustained impairment. For patients with missing week 104 HAQ-DI score, the AUC of the change from baseline was standardized to 104 weeks using the latest timepoint available for calculation of the AUC. A negative change from baseline indicated improvement.|Baseline to Week 104|Participants from the Intent-to-treat population (all randomized participants who received at least one dose of study drug) with data available for analysis. No imputation was used for missing HAQ scores. For patients who received escape therapy, the HAQ-DI was set to missing from the time they entered escape.||Score on a scale*week||Full Range|Least Squares Mean
705322|NCT00106535|Primary|Change From Baseline in the Modified Total Sharp-Genant Score at Week 104|Radiographs of each hand and foot were taken at Baseline and Week 104 and evaluated at a central reading service by two independent radiologists using the Genant modified method according to Sharp. Erosion Score: A total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion. Joint Narrowing Score: A total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint). The maximum total erosion score in the hands is 100 and in the feet 42, the maximum scores for joint space narrowing in the hands is 100 and in the feet 48. The maximum modified Sharp score achievable is 290. A lower number change from Baseline indicated a better score.|Baseline, Week 104|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Data collected after withdrawal or for patients on escape therapy the data is excluded. Missing data was imputed using linear extrapolation.||Score on a scale||Standard Deviation|Mean
705323|NCT00106535|Primary|Change in Physical Function as Measured by the Area Under the Curve (AUC) for the Change From Baseline in the Health Assessment Questionnaire (HAQ) Disability Index at Week 52|HAQ-DI consisted of 20 questions in 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities rated on a 4-point scale where 0=without any difficulty to 3=unable to do. The sum of scores was divided by the number of domains with a score for a total possible score of 0 (best) to 3 (worst). Functional disability was determined as a cumulative measure of HAQ-DI over 1 year by using the AUC of the change from baseline in HAQ-DI score through week 52. Decreases in AUC of change from baseline in HAQ-DI indicate a greater average improvement in physical function over time and represent a decrease in sustained impairment. For patients with missing week 52 HAQ-DI score, the AUC of the change from baseline was standardized to 52 weeks using the latest timepoint available for calculation of the AUC. The mean was adjusted for region. A negative change from baseline indicated improvement.|Baseline to Week 52|Participants from the Intent-to-treat population (all randomized participants who received at least one dose of study drug) with data available for analysis. No imputation was used for missing HAQ scores. All assessments were set to missing after a patient received escape therapy.||Score on a scale*week||Full Range|Least Squares Mean
705324|NCT00106535|Primary|Change From Baseline in Modified Total Sharp-Genant Score at Week 52|Radiographs were taken of each hand and foot at Baseline and Week 52 and evaluated at a central reading service by two independent radiologists using the Genant modified method according to Sharp. Erosion Score: A total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion. Joint Narrowing Score: A total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint). The maximum total erosion score in the hands is 100 (normalized from 98) and in the feet 42, the maximum scores for joint space narrowing in the hands is 100 (normalized from 104) and in the feet 48. The maximum modified Sharp score achievable is 290. A lower number change from Baseline indicated a better score.|Baseline, Week 52|Participants from the Intent-to-treat (ITT) population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Linear extrapolation was used to impute missing week 52 data. Data collected after withdrawal or on escape therapy is excluded.||Score on a scale||Standard Deviation|Mean
705348|NCT00106639|Secondary|Number of Participants With Drug Usage|Lipid lowering agents, antihypertensive agents, oral hypoglycemic agents (OHA) , anti-diabetic agents (ADA) and insulin drug usage was collected.|Baseline, Day 14, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. Here ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.||participants|||Number
705325|NCT00106535|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI): Mean Change From Baseline at Week 24|HAQ-DI is a self-completed patient questionnaire specific for RA. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities. Each domain has at least 2 component questions. There are 4 possible responses for each component 0=without any difficulty 1=with some difficulty 2=with much difficulty 3=unable to do. Calculate HAQ-DI the patient must have a domain score for at least 6 of 8 domains. The HAQ-DI is the sum of the scores, divided by the number of domains that have a score (in range 6-8) for a total possible score minimum/maximum 0 (best) to 3 (worst). A negative change from baseline indicated improvement.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug, with data available for analysis. No imputation was used for missing HAQ-DI. All assessments were set to missing from the time a patient received escape therapy.||Scores on a scale||Standard Deviation|Mean
705326|NCT00106535|Secondary|Erythrocyte Sedimentation Rate: Mean Change From Baseline at Week 24|The Erythrocyte Sedimentation Rate (ESR) was measured in mm/hr. A reduction in the level is considered an improvement.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug, with data available for analysis. No imputation was used for missing ESR. All assessments were set to missing from the time a patient received escape therapy.||millimeters/hour (mm/hr)||Standard Deviation|Mean
705327|NCT00106535|Secondary|C-Reactive Protein (CRP): Mean Change From Baseline at Week 24|The serum concentration of C-Reactive Protein (CRP) is measured in mg/dL. A reduction in the level is considered an improvement.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug, with data available for analysis. No imputation was used for missing CRP. All assessments were set to missing from the time a patient received escape therapy.||milligrams/deciliter (mg/dL)||Standard Deviation|Mean
705328|NCT00106535|Secondary|Patient's Pain VAS: Mean Change From Baseline at Week 24|The patient assessed their pain on a 0 to 100 millimeter (mm) horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 mm, and is described as “no pain” and the right-hand extreme equals 100 mm as “unbearable pain”. A negative change indicated improvement.|Baseline and Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug, with data available for analysis. No imputation used for missing VAS assessments. All assessments were set to missing from the time a patient received escape therapy.||mm||Standard Deviation|Mean
705329|NCT00106535|Secondary|Physician's Global VAS: Mean Change From Baseline at Week 24|The physician’s global assessment of disease activity is assessed on a 0 to 100 mm horizontal visual analogue scale (VAS) by the physician. The left-hand extreme of the line equals 0 mm, and is described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm as “maximum disease activity” (maximum arthritis disease activity).|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug, with data available for analysis. No imputation was used for missing VAS assessments. All assessments were set to missing from the time a patient received escape therapy.||mm||Standard Deviation|Mean
705330|NCT00106535|Secondary|Patient's Global Visual Analog Scale (VAS): Mean Change From Baseline at Week 24|The patient’s global assessment of disease activity is assessed on a 0 to 100 mm horizontal visual analogue scale (VAS) by the patient. The left-hand extreme of the line equals 0 mm, and is described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as “maximum disease activity” (maximum arthritis disease activity). A negative change from Baseline indicated improvement.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug, with data available for analysis. No imputation was used for missing VAS assessments. All assessments were set to missing from the time a patient received escape therapy.||millimeters (mm)||Standard Deviation|Mean
705331|NCT00106535|Secondary|Tender Joint Count (68 Joint Count): Mean Change From Baseline at Week 24|68 joints are assessed for tenderness and joints are classified as tender/not tender giving a total possible tender joint count score of 0 to 68.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug, with data available for analysis. LOCF was used for swollen joint counts. All assessments were set to missing from the time a patient received escape therapy and only pre-escape therapy joint count assessments were carried forward.||joint count||Standard Deviation|Mean
705332|NCT00106535|Secondary|Swollen Joint Count (66 Joint Count): Mean Change From Baseline at Week 24|66 joints were assessed for swelling and joints are classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66.|Baseline, Week 24|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF was used for swollen joint counts. All assessments were set to missing from the time a patient received escape therapy and only pre-escape therapy joint count assessments were carried forward.||joint count||Standard Deviation|Mean
705333|NCT00106535|Secondary|Percentage of Participants With ACR70 Response|ACR70 response is defined as a ≥ 70% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient’s Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient’s Global Assessment of Disease Activity and Physician’s Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].|Baseline,Week 24|Intent-to-treat population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who received escape therapy, withdrew prematurely or where an ACR could not be calculated, were set to 'Non Responder'.||Percentage of participants|||Number
705349|NCT00106639|Secondary|Supine Systolic and Diastolic Blood Pressure (BP)||Baseline, Day 2, 3, 14, Month 1, 3, 6|Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.||millimeter of mercury||Standard Deviation|Mean
705334|NCT00106535|Secondary|Percentage of Participants With ACR50 Response|ACR50 response is defined as a ≥ 50% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient’s Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient’s Global Assessment of Disease Activity and Physician’s Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].|Baseline, Week 24|Intent-to-treat population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who received escape therapy, withdrew prematurely or where an ACR could not be calculated, were set to 'Non Responder'.||Percentage of participants|||Number
705335|NCT00106535|Primary|Percentage of Participants With American College of Rheumatology-ACR20 Response|ACR20 response is defined as a ≥ 20% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient’s Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient’s Global Assessment of Disease Activity and Physician’s Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.|Baseline, Week 24|Intent-to-treat (ITT) population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who received escape therapy, withdrew prematurely or where an ACR could not be calculated, were set to 'Non Responder'.||Percentage of participants|||Number
705336|NCT00106626|Secondary|Safety and Tolerability as Measured by the Number of Participants With Disease Progression|Number of participants with disease progression (protocol-mandated reason for discontinuation). Disease progression was determined by the principle investigator.|Any time during 8 cycle treatment period through 30 days after.|All participants. Treated Population includes all participants who received at least one dose and had efficacy measurements at baseline and at least one post baseline treatment.||Participants|||Number
705337|NCT00106626|Primary|Maximum Tolerated Dose (MTD) Status as Determined by Number of Participants With Dose Limiting Toxicity (DLT) at Each Dose Level|MTD was determined by the occurrence of DLTs during the first treatment cycle. DLT describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment. The dose level is equal to the MTD if < 2 patients experience a DLT and is also the highest tolerated dose level in the cohort.|Cycle 1 (21 days)|A total of 52 participants were enrolled in this study. Six were violations pts (1 in Cohort C Dose Level 1, 1 in Cohort C Dose Level 2, 3 in Cohort D Dose Level 1, and 1 in Cohort D Dose Level 2) and were replaced. None of the violations pts had any DLTs in the first cycle of the study.||Participants|||Number
705338|NCT00106639|Secondary|Number of Participants With Discontinuation||Month 1, 2, 3, 4, 5, 6|FAS included all randomized participants who received at least 1 dose of study medication.||participants|||Number
705339|NCT00106639|Secondary|Electrocardiogram (ECG) Parameters|ECG parameters included PR interval, QT interval, corrected QT using Bazett's formula (QTcB) and QTc using Fridericia's formula (QTcF) interval, and QRS width.|Baseline, Month 3, 6|Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.||millisecond||Standard Deviation|Mean
705340|NCT00106639|Secondary|Alanine Aminotransferase (ALT) Level|ALT is the enzyme found in the liver and it is measured to see if the liver is damaged or diseased.|Baseline, Day 14, Month 1, 3, 6|Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here, ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.||unit/liter||Standard Deviation|Mean
705341|NCT00106639|Secondary|Hematocrit Level|The hematocrit is recorded as the percentage of volume of red blood cells (RBCs) in a blood sample.|Baseline, Day 14, Month 1, 3, 6|Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.||percentage of blood||Standard Deviation|Mean
705342|NCT00106639|Secondary|Hemoglobin Level|Hemoglobin is the protein molecule in red blood cells that carries oxygen from the lungs to the body's tissues and returns carbon dioxide from the tissues back to the lungs.|Baseline, Day 14, Month 1, 3, 6|Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.||g/dL||Standard Deviation|Mean
705343|NCT00106639|Secondary|Absolute Platelet Levels||Baseline, Day 14, Month 1, 3, 6|Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here ‘n’ signifies those participants evaluable at specific time points.||platelets*10^3/mm^3||Standard Deviation|Mean
705344|NCT00106639|Secondary|Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil||Baseline, Day 14, Month 1, 3, 6|Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here ‘n’ signifies those participants evaluable at specific time points.||cells*10^3/mm^3||Standard Deviation|Mean
705345|NCT00106639|Secondary|Number of Participants With Cytomegalovirus (CMV) Disease||Month 3, 6|FAS included all randomized participants who received at least 1 dose of study medication and based on time due to lost of follow-up, or up to Month 6. Here, N (Number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.||participants|||Number
705351|NCT00106639|Secondary|Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels||Baseline, Day 14, Month 1, 3, 6|Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.||mg/dL||Standard Deviation|Mean
705352|NCT00106639|Secondary|Number of Participants With Hypercholesterolemia|Hypercholesterolemia is a condition characterized by very high levels of cholesterol in the blood. Hypercholesterolemia was defined as a value of total serum cholesterol greater than 240 mg/dL.|Baseline, Day 14, Month 1, 3, 6|Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.||participants|||Number
705353|NCT00106639|Secondary|Fasting Serum Glucose Levels||Baseline, Day 14, Month 1, 3, 6|Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.||mg/dL||Standard Deviation|Mean
705354|NCT00106639|Secondary|Number of Participants With New Onset Diabetes Mellitus (NODM)||Month 3, 6|FAS included all randomized participants who received at least 1 dose of study medication.||participants|||Number
705355|NCT00106639|Secondary|Number of Participants With First Clinically Significant Infection|Clinically significant (Viral, Bacterial and Fungal) infection was defined as the presence of presumed or documented infection confirmed by culture, biopsy, genomic or serologic findings post-randomization and required hospitalization or anti-infective treatment, or otherwise deemed significant by the Investigator.|Month 3, 6|FAS included all randomized participants who received at least 1 dose of study medication.||participants|||Number
705356|NCT00106639|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 2 months after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to Month 8 (2 months follow-up)|Safety analysis set included all randomized participants who received at least 1 dose of study medication.||participants|||Number
705357|NCT00106639|Secondary|Glomerular Filtration Rate (GFR) by Reciprocal of Serum Creatinine (1/sCr)|GFR is a measure of renal function. The reciprocal of serum creatinine is an estimate of GFR.|Day 14, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies those participants evaluable at specific time points.||deciliter/mg (dL/mg)||Standard Deviation|Mean
705358|NCT00106639|Secondary|Glomerular Filtration Rate (GFR) by Modification of Diet in Renal Disease (MDRD) Equation|GFR: index of kidney function described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR was calculated using MDRD equation. GFR by MDRD equation= 170 * (serum creatinine) ^ (-0.999)*(age in years)^(-0.176)*(0.762 if female) * (1.18 if black)*(blood urea nitrogen concentration)^(-0.170)*(serum albumin concentration)^(0.318). Normal GFR is >90 mL/min/1.73 square meter (m^2), although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR <15 mL/min indicated kidney failure.|Day 14, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies those participants evaluable at specific time points for each group respectively.||mL/min/1.73 m^2||Standard Deviation|Mean
705359|NCT00106639|Secondary|Glomerular Filtration Rate (GFR) by Cockcroft-Gault|GFR: index of kidney function described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR was calculated using Cockcroft-Gault equation. GFR by Cockcroft-Gault equation= body weight*(140 minus age in years) divided by (72*serum creatinine). For females, value obtained was multiplied by 0.85. A normal GFR is >90 mL/min, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR <15 mL/min indicated kidney failure.|Day 14, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.||mL/min||Standard Deviation|Mean
705360|NCT00106639|Secondary|Healthcare Resource Utilization Questionnaire (HCRUQ) - 5th Question|"Fifth question in the HCRUQ was “Upon discharge from the hospital, did you return to your previous place of residence?” and number of participants who responded yes or no to the question was reported."|Month 6|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies participants evaluable for this measure.||participants|||Number
705361|NCT00106639|Secondary|Healthcare Resource Utilization Questionnaire (HCRUQ)|Healthcare Resource Utilization Questionnaire (HCRUQ) was used to assess healthcare resources which included number of events such as physician and other health professional visits, number of treatments or diagnostic tests, number of hospitalizations, and number of emergency room visits.|Baseline, Month 6|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.||events||Standard Deviation|Mean
705404|NCT00106938|Secondary|Freedom From Clinically Indicated Target Lesion Revascularization|Freedom from CITLR was defined as freedom from reintervention for ≥ 50% restenosis in recently symptomatic patients and ≥ 80% restenosis in asymptomatic patients.|0 to 1460 days|||percentage of partcipants|||Number
705405|NCT00106938|Secondary|Freedom From Clinically Indicated Target Lesion Revascularization|Freedom from CITLR was defined as freedom from reintervention for ≥ 50% restenosis in recently symptomatic patients and ≥ 80% restenosis in asymptomatic patients.|0 to 1095 days|||percentage of partcipants|||Number
705362|NCT00106639|Secondary|End-Stage Renal Disease Symptom Checklist-Transplantation Module (ESRD-SCL)|ESRD-SCL:43-item disease specific self-administered questionnaire. Participants’ rated question“At the moment,how much do you suffer?”for each item on 5 point scale,ranged (Ra) 0(not at all)to 4(extremely).Consisted of 6 subscales:cardiac and renal dysfunction;Ra 0-28,increased(In) growth of gum and hair;Ra 0-20,limited cognitive capacity;Ra 0-32,limited physical capacity;Ra 0-40,side effects (SEs) of corticosteroids;Ra 0-20,transplantation associated psychological distress(TAPD);Ra 0-32(higher scores=greater dysfunction for each subscale).Total score:0-172,higher scores=greater dysfunction.|Baseline, Month 6|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.||units on a scale||Standard Deviation|Mean
705363|NCT00106639|Secondary|36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical and mental component scores (CS). Total of 11 variables were analyzed (8 subscales, 2 composite subscales and Question 2 “how would you rate your health in general now?” (range 1= better, 5= worst). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline, Month 6|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.||units on a scale||Standard Deviation|Mean
705364|NCT00106639|Secondary|Trough Levels of Tacrolimus (TAC)||Pre-dose on Day 14, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
705365|NCT00106639|Secondary|Reticulocyte Count|Reticulocytes are slightly immature red blood cells in the blood. Reticulocyte counts are reported as cells*10^3 per cubic millimeter (cells*10^3/mm^3).|Baseline, Day 14, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. Here ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.||cells*10^3/mm^3||Standard Deviation|Mean
705366|NCT00106639|Secondary|Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets|The absolute cell counts of cluster of differentiation 8 (CD8): Cytotoxic T-lymphocytes reactive with major histocompatibility complex-1 (MHC-I), CD19: B- Lymphocytes, CD56: natural killer cells were determined using FACS, a specialized type of flow cytometry which sorts a heterogeneous mixture based upon the specific light scattering and fluorescent characteristics of each cell.|Baseline, Day 14, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.||cells per microliter (cells/mcL)||Standard Deviation|Mean
705367|NCT00106639|Secondary|Population Pharmacokinetics (PK)|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Pre-dose on Day 1, 3, 7, 14, Month 1, 3, 6, between 1 to 2 hours post-dose at Month 3 and between 3 to 4 hours post-dose at Month 6||||||
705368|NCT00106639|Secondary|Number of Participants With Rejection|Rejection was defined as first occurrence of BPAR, antibody mediated rejection, or suspicious for acute rejection.|Month 3, 6|FAS included all randomized participants who received at least 1 dose of study medication.||participants|||Number
705369|NCT00106639|Secondary|Number of Participants Who Died||Month 6|FAS included all randomized participants who received at least 1 dose of study medication.||participants|||Number
705370|NCT00106639|Secondary|Number of Participants With Graft Loss|Graft loss was defined as graft nephrectomy, participant's death due to graft loss, re-transplantation, or return to dialysis for greater than or equal to (>=) 6 consecutive weeks.|Month 6|FAS included all randomized participants who received at least 1 dose of study medication.||participants|||Number
705371|NCT00106639|Secondary|Number of Participants With Efficacy Failure|Efficacy failure was the first occurrence of BPAR, graft loss or participant's death.|Month 3, 6|FAS included all randomized participants who received at least 1 dose of study medication.||participants|||Number
705372|NCT00106639|Secondary|Number of Participants With Ordered Categorical Severity of First Biopsy Proven Chronic Allograft Nephropathy (BPCAN)|Ordered categorical severity of first BPCAN was classified according to the Banff Classification. Grade I: mild, grade II: moderate and grade III: severe interstitial fibrosis and tubular atrophy/loss. (Racusen et al: The Banff classification, 1999).|Month 3, 6|FAS included all randomized participants who received at least 1 dose of study medication.||participants|||Number
705373|NCT00106639|Secondary|Number of Participants With Ordered Categorical Severity of First Biopsy Proven Acute Rejection (BPAR)|Ordered categorical severity of first BPAR was classified according to the Banff Classification. Grade IA: moderate tubulitis, grade IB: severe tubulitis, grade IIA: mild to moderate intimal arteritis, grade IIB: severe intimal arteritis, grade III: transmural arteritis. (Racusen et al: The Banff classification, 1999).|Month 3, 6|FAS included all randomized participants who received at least 1 dose of study medication.||participants|||Number
705374|NCT00106639|Secondary|Number of Participants With First Biopsy Proven Chronic Allograft Nephropathy (BPCAN)|BPCAN categorized as chronic allograft nephropathy as interpreted by the central blinded pathologist according to the Banff 97 working classification.|Month 3, 6|FAS included all randomized participants who received at least 1 dose of study medication.||participants|||Number
705375|NCT00106639|Secondary|Number of Participants With First Biopsy Proven Acute Rejection (BPAR) at Month 3|BPAR categorized as acute rejection as interpreted by the central blinded pathologist according to the Banff 97 working classification.|Baseline up to Month 3|FAS included all randomized participants who received at least 1 dose of study medication.||participants|||Number
731773|NCT00399542|Secondary|Month 2 Abdominal Pain Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|28 days|ITT with LOCF||units on a scale||Standard Deviation|Mean
705377|NCT00106639|Primary|Glomerular Filtration Rate (GFR) by Nankivell Equation at Month 6|GFR: index of kidney function described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR was calculated by creatinine clearance (CLcr) using Nankivell equation. CLcr by Nankivell equation= (6.7 per serum creatinine) plus (0.25*body weight) minus (0.5*serum urea) minus (100 per square height) plus (35 for male/25 for female). A normal GFR is >90 milliliter/minute (mL/min), although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR <15 mL/min indicated kidney failure.|Month 6|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies those participants evaluable for this measure.||mL/min||Standard Deviation|Mean
705378|NCT00106639|Primary|Number of Participants With First Biopsy Proven Acute Rejection (BPAR) at Month 6|BPAR categorized as acute rejection as interpreted by the central blinded pathologist according to the Banff 97 working classification.|Baseline up to Month 6|Full analysis set (FAS) included all randomized participants who received at least 1 dose of study medication.||participants|||Number
705379|NCT00106704|Secondary|Change From Baseline in FPG at Week 24|The change from baseline is the Week 24 Fasting Plasma Glucose (FPG) minus the Week 0 FPG.|Baseline and 24 Weeks|All Patients Treated included patients who received at least 1 dose of study therapy, and had a baseline value and ≥1 post-baseline value for this outcome. The last post-baseline observed measurement was carried forward to Week 24 for patients with no data at Week 24. Data after rescue were considered missing.||mg/dL||95% Confidence Interval|Least Squares Mean
705380|NCT00106704|Primary|Change From Baseline in A1C at Week 24|Hemoglobin A1C (A1C) is measured as percent. Thus this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.|Baseline and 24 Weeks|All Patients Treated included patients who received at least 1 dose of study therapy, and had a baseline value and ≥1 post-baseline value for this outcome. The last post-baseline observed measurement was carried forward to Week 24 for patients with no data at Week 24. Data obtained after glycemic rescue were considered missing.||Percent||95% Confidence Interval|Least Squares Mean
705381|NCT00106938|Secondary|Freedom From Death, Stroke and MI Within 30 Days and Ipsilateral Stroke From 31 Days to 5 Years||0 to 5 years|||percentage of participants|||Number
705382|NCT00106938|Secondary|Death or Major Stroke (Hierarchical)||≤ 30 Days Post Index Procedure|Analysis population Includes only the most serious event for each subject and includes only each subject's first occurrence of the event. Subjects who did not complete 30 day follow-up and did not have any death, stroke or MI events are excluded.||percentage of participants||95% Confidence Interval|Number
705383|NCT00106938|Secondary|Death or Stroke (Hierarchical)||≤ 30 Days Post Index Procedure|Analysis population Includes only the most serious event for each subject and includes only each subject's first occurrence of the event. Subjects who did not complete 30 day follow-up and did not have any death, stroke or MI events are excluded.||percentage of participants||95% Confidence Interval|Number
705384|NCT00106938|Secondary|Death, Stroke or Myocardial Infarction (MI) (Hierarchical)||≤ 30 Days Post Index Procedure|Analysis population Includes only the most serious event for each subject and includes only each subject's first occurrence of the event. Subjects who did not complete 30 day follow-up and did not have any death, stroke or MI events are excluded.||percentage of participants||95% Confidence Interval|Number
705385|NCT00106938|Secondary|Myocardial Infarction (MI) (Non-Hierarchical)||≤ 30 Days Post Index Procedure|Analysis population Includes only the most serious event for each subject and includes only each subject's first occurrence of the event. Subjects who did not complete 30 day follow-up and did not have any death, stroke or MI events are excluded.||percentage of participants||95% Confidence Interval|Number
705386|NCT00106938|Secondary|All Stroke (Non-Hierarchical)||≤ 30 Days Post Index Procedure|Analysis population Includes only the most serious event for each subject and includes only each subject's first occurrence of the event. Subjects who did not complete 30 day follow-up and did not have any death, stroke or MI events are excluded.||percentage of participants||95% Confidence Interval|Number
705387|NCT00106938|Secondary|Death (Non-Hierarchical)||≤ 30 Days Post Index Procedure|Analysis population Includes only the most serious event for each subject and includes only each subject's first occurrence of the event. Subjects who did not complete 30 day follow-up and did not have any death, stroke or MI events are excluded.||percentage of participants||95% Confidence Interval|Number
705388|NCT00106938|Secondary|Freedom From All Stroke||0 to 1825 days|||percentage of participants|||Number
705389|NCT00106938|Secondary|Freedom From All Stroke||0 to 1460 days|||percentage of participants|||Number
705390|NCT00106938|Secondary|Freedom From All Stroke||0 to 1095 days|||percentage of participants|||Number
705391|NCT00106938|Secondary|Freedom From All Stroke||0 to 730 days|||percentage of participants|||Number
705392|NCT00106938|Secondary|Freedom From All Stroke||0 to 365 days|||percentage of participants|||Number
705393|NCT00106938|Secondary|Freedom From Mortality||0 to 1825 days|||percentage of participants|||Number
705394|NCT00106938|Secondary|Freedom From Mortality||0 to 1460 days|||percentage of participants|||Number
705395|NCT00106938|Secondary|Freedom From Mortality||0 to 1095 days|||percentage of partcipants|||Number
705396|NCT00106938|Secondary|Freedom From Mortality||0 to 730 days|||percentage of participants|||Number
705397|NCT00106938|Secondary|Freedom From Mortality||0 to 365 days|||percentage of participants|||Number
705398|NCT00106938|Secondary|Freedom From Ipsilateral Stroke|Ipsilateral stroke was defined as stroke in the vascular distribution of the study carotid artery. If a subject experienced a bilateral stroke it was counted as an ipsilateral stroke for analysis purposes.|31 to 1825 days|||percentage of participants|||Number
705399|NCT00106938|Secondary|Freedom From Ipsilateral Stroke|Ipsilateral stroke was defined as stroke in the vascular distribution of the study carotid artery. If a subject experienced a bilateral stroke it was counted as an ipsilateral stroke for analysis purposes.|31 to 1460 days|||percentage of participants|||Number
705400|NCT00106938|Secondary|Freedom From Ipsilateral Stroke|Ipsilateral stroke was defined as stroke in the vascular distribution of the study carotid artery. If a subject experienced a bilateral stroke it was counted as an ipsilateral stroke for analysis purposes.|31 to 1095 days|||percentage of participants|||Number
710839|NCT00168818|Secondary|Death During Treatment Period|All cause death, as adjudicated by the VTE events committee|First administration until 31-38 days|Full Analysis Set - op (all patients who are treated and operated)||Participants|||Number
705410|NCT00106938|Secondary|Procedural Success|Procedural success is defined as the attainment of target lesion final residual diameter stenosis of < 50% by QCA (if QCA is not available, the visual estimate of diameter stenosis will be used) using any procedural method and freedom of Major Adverse Event at 30 days.|0 to 30 days post procedure|The analysis population is Procedure success is per subject basis including the attempted CAS (carotid artery stenting) procedure only. CEA group is not part of analysis population for procedure success.||percentage of participants|||Number
705411|NCT00106938|Secondary|Acute Device Success: Embolic Protection Device System|Defined as successful deployment and retrieval of the filter in the absence of angiographic distal embolization.|On day 0 after index procedure|Device success is per device basis including the attempted devices only, including the attempted Carotid Artery Stenting (CAS) device only.||Percentage of devices|Devices|95% Confidence Interval|Mean
705412|NCT00106938|Secondary|Acute Device Success: Xact Carotid Stent|Defined as attainment of final residual diameter stenosis of < 50% by Qualitative Comparative Analysis (QCA) (if QCA is not available, the visual estimate of diameter stenosis will be used) covering an area no longer than the original lesion with the study stent. (Routine post-dilatation of the stent may be included in this definition). Placement of an additional stent to treat a dissection or procedural complication as a bailout will not be considered a device success.|On day 0 after index procedure|Device success is per device basis including the attempted devices only, including the attempted Carotid Artery Stenting (CAS) device only.||percentage of devices|devices|95% Confidence Interval|Number
705413|NCT00106938|Primary|Composite of Death, Stroke (Ipsilateral or Contralateral; Major or Minor) and Myocardial Infarction (DSMI) Through 30 Days Post-procedure, Plus Ipsilateral Stroke 31 to 365 Days.||0 to 365 days|||percentage of participants|||Number
705414|NCT00106964|Secondary|Sero-Response to Hepatitis B Surface Antigen; Predictor: STUDY ARM|Response rate associated with the participant's study arm, baseline CD4 count, and interaction term that reflects how subjects in Arm 2 responded differently depending on their CD4 count. Response is defined as greater than or equal to 10 IU/mL of serum being present; non-response is defined as less than 10 IU/mL.|Week 28|All participants who had a Week 28 Hepatitis B serology result||percentage of participants who responded|||Number
705415|NCT00106964|Secondary|Response Rates in HIV+ Youth Within Each Study Arm by Study Duration|Within each arm, the duration of response in HIV-infected youth was analyzed for all subjects who were responders at 28 weeks. The possible values for response duration could be 20 weeks or less (responder at 28 weeks but not at 48 weeks), 20 to 44 weeks (responder at 28 and 48 weeks but not at 72 weeks), or greater than 44 weeks (responder at 28, 48, and 72 weeks). A response of greater than 20 weeks includes those who responded after 20 weeks, but whose exact response duration was unknown.|Entry through Week 72|Population analyzed were those who had an antibody titer measured at Week 28.||percentage of participants who responded|||Number
705416|NCT00106964|Secondary|Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth – ABNORMAL LABORATORY VALUES GRADE 2 OR ABOVE BY INTERVENTION ARM ON STUDY|The number of adverse events and subjects with the events were described by study arm. The proportion of subjects with abnormal labs in Arms 1 and each of the two alternative strategy arms (Arm 2 and Arm 3) were compared to assess whether or not there is a difference in subjects with grade 3 or 4 toxicity. The laboratory events included are AEs classified as probably, possibly, or definitely related to study drug as classified by the Site Investigator.|Baseline through Week 72|All enrolled participants were included in this analysis. The following no. of participants experienced at least one Grade 2 or higher abnormal labs by study arm.||Events|Events||Number
705417|NCT00106964|Secondary|Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth - ADVERSE EVENTS BY INTERVENTION ARM ON STUDY - DEFINITELY RELATED|The number of AEs was described by study arm. The proportion of subjects with clinical AEs in Arms 1 and each of the two alternative strategy arms (Arm 2 and Arm 3)were compared to assess whether or not there is a difference in subjects with any grade toxicity.|Baseline through Week 72|All enrolled participants were included in this analysis of AEs that were definitely related to study drug. There were no AEs above Grade 2 considered to be definitely related to study drug.||event|||Number
705418|NCT00106964|Secondary|Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth - ADVERSE EVENTS BY INTERVENTION ARM ON STUDY - POSSIBLY OR PROBABLY RELATED|The number of adverse events (AE) was described by study arm. The proportion of subjects with clinical adverse events in Arms 1 and each of the two alternative strategy arms (Arm 2 and Arm 3) were compared to assess whether or not there is a difference in patients with any grade toxicity.|Baseline through Week 72|All enrolled participants were included in this analysis of all AEs that were possibly or probably related to study drug. There were no AEs above Grade 3 considered to be possibly or probably related to study drug.||Events|||Number
705419|NCT00106964|Primary|Sero-response to Hepatitis B Surface Antigen|The primary outcome, percentage positive sero-response, was compared between Arm 1 and each of the two alternative strategy arms (Arm 2 and Arm 3) and measured 4 weeks after the third vaccination at Week 28. Response is defined as greater than or equal to 10 IU/mL of serum being present; non-response is defined as less than 10 IU/mL.|Week 28|Participants who completed a Week 28 visit with a Hepatitis B serology result were included in this analysis.||percentage of participants who resonded|||Number
705420|NCT00107042|Secondary|Assessment of Youth Understanding of Vaccine Trial and Informed Consent|Assessment of understanding was measured by a questionnaire containing six questions. The summary score is the sum of correct answers from six questions.|Screening|||Number of correct answers||Standard Deviation|Mean
705421|NCT00107042|Secondary|As Treated Analysis – Adequate Antibody Response to Hep B Surface Antigen|The subject was considered seroresponsive to Hepatitis B Surface Antigen if the serum antibody level was greater than or equal to 10 mIU/mL. Those who received only a single vaccination, whose second vaccination was outside of the specified time window, or other cases of protocol violations were excluded from the analysis.|Week 28|Subjects who completed both vaccinations according to the protocol were included in the analysis (as treated analysis). Those who only had 1 vaccination,whose 2nd vaccination was outside the specified time window, or other cases of protocol violations, were excluded from the analysis.||percentage of participants|||Number
705449|NCT00107120|Other Pre-specified|Children's Global Assessment Scale|Change from baseline to week 8 in CGAS score which rates the patient's general level of functioning for the past 14 days on a scale of 1 (most impaired) to 100 (healthiest).|At baseline and end of week 8|The Intent-To-Treat Population was used. The Last Observation Carried Forward (LOCF) technique was used to impute missing data.||Change in score||Standard Error|Mean
705422|NCT00107042|Secondary|Immunogenicity to Hep A in Twinrix Arm: Overall Response (1-month or 12-month After 2nd Vaccination)|Hepatitis A antibody response in those subjects in the combined vaccine arm (Twinrix) at two time points: 1 and 12 months after the 2nd vaccination. Immunogenicity to Hepatitis is given as a positive or negative response.|Week 28 and Week 76|Subjects in the Twinrix arm who had week 28 &/or wk 76 HepA serology results were included. For overall response analysis, if a subject was reactive at either wk 28 or wk 76, then the overall response for subject was considered “Positive”. If subject was non-reactive at both wk 28and wk 76, then the overall response for subject was “Negative”.||percentage of participants|||Number
705423|NCT00107042|Secondary|Immunogenicity to Hep A in Twinrix Arm: Twelve Months Post 2nd Vaccination|Hepatitis A antibody response in those subjects in the combined vaccine arm (Twinrix) at 12 months after the 2nd vaccination. Immunogenicity to Hepatitis is given as a positive or negative response.|Week 76|Subjects in the Twinrix arm who had a Week 76 hepatitis A serology results were included in this analysis.||percentage of participants|||Number
705424|NCT00107042|Secondary|Immunogenicity to Hep A in the Twinrix Arm: One Month Post 2nd Vaccination|Hepatitis A antibody response in those subjects in the combined vaccine arm (Twinrix) at 1 month after the 2nd vaccination. Immunogenicity to Hepatitis is given as a positive or negative response. If the Hepatitis A serology was reactive, then the participant was considered to have a positive response; if the Hepatitis A serology was non-reactive, then the participant was considered to have a negative response.|Week 28|The data for this analysis included those in the Twinrix arm who had week 28 hepatitis A serology results.||percentage of participants|||Number
705425|NCT00107042|Secondary|Immunogenicity to Hep B 18 Months After First Immunization|Persistence of protective antibody response was measured by presence or absence of 10 mIU/ml HepB surface antibody and geometric mean titer of the same antibody at Week 76|Week 76|"Participants who had a week 76 Hepatitis B antibody titer were included in this analysis.
One subject had an a'body titer at EOS visit but did not have a'body data at week 76. Since the EOS was close to week 76, the titer from EOS was recoded as the week 76 titer."||Participants|||Number
705426|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER USED DRUGS NOT PRESCRIBE|Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Whether participants ever used drugs not prescribed was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.|Week 28|Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.||Participants|||Number
705427|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER SMOKED MARIJUANA|Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Whether participants ever smoked marijuana was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.|Week 28|Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.||Participants|||Number
705428|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER DRANK ALCOHOL|Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Whether participants ever drank alcohol was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.|Week 28|Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.||Participants|||Number
705429|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TOTAL LIFETIME FEMALE SEX PARTNERS|Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Total number of lifetime female sex partners was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.|Week 28|Participants who had a Wk 28 hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.||Participants|||Number
705430|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TOTAL LIFETIME MALE SEX PARTNERS|Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Total number of lifetime male sex partners was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.|Week 28|Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.||Participants|||Number
705838|NCT00112437|Secondary|Percentage Change in Total Hip Bone Mineral Density at 12 Months|Percentage change in total hip Bone Mineral Density (relative to baseline) at 12 Months|Baseline and 12 months|This analysis was performed at Month 12 using Full-Analysis-Set approach with Last Observation Carried Forward.||Percent Change||95% Confidence Interval|Least Squares Mean
705431|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TOTAL LIFETIME SEX PARTNERS|Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Total number of lifetime sex partners was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.|Week 28|Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.||Participants|||Number
705432|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: AGE AT WHICH SUBJECT FIRST HAD SEX (NOT FORCED)|Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Age of participants’ first unforced sexual encounter was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.|Week 28|Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.||Participants|||Number
705433|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: SEXUAL IDENTITY|Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Sexual identity was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.|Week 28|Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.||Participants|||Number
705434|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER SMOKED CIGARETTES|Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Whether participants ever smoked cigarettes was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.|Week 28|Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.||Participants|||Number
705435|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: BMI at Baseline|Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. BMI at baseline was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.|Week 28|Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.||Participants|||Number
705436|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TANNER STAGE FOR MALES|Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Tanner stage by gender was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.|Week 28|Male participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer isn't sufficiently predictive of Wk 28 titer.||Participants|||Number
705437|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TANNER STAGE FOR FEMALES|Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Tanner stage by gender was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.|Week 28|Females who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer isn't sufficiently predictive of the Wk 28 titer.||Participants|||Number
705438|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: RACE|Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Race was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.|Week 28|Participants who had a wk 28 hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the wk 28 titer.||Participants|||Number
705439|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: HISPANIC ETHNICITY|Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Hispanic ethnicity was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.|Week 28|Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.||Participants|||Number
705440|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: GENDER|Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum a'body level is < 10 mIU/mL. Gender was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.|Week 28|Participants who had a wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.||Participants|||Number
705441|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: AGE|Qualitative Vaccine Response to Hepatitis B (Hep B)Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Age was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.|Week 28|Participants who had a Wk 28 hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.||Participants|||Number
705442|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: SITE EFFECT|Qualitative Vaccine Response to Hepatitis B Surface Antigen is defined as a “Responder” if serum antibody level is >= 10 mIU/mL and a “Non- Responder” if a serum a'body level is < 10 mIU/mL. Site effect was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.|Week 28|Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.||Participants|||Number
705443|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen (Binary); Predictor: STUDY ARM.|Qualitative Vaccine Response to Hepatitis B Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Study arm was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.|Week 28|Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.||Participants|||Number
705444|NCT00107042|Secondary|Unadjusted Relationship of Hepatitis B Vaccine Response (Log10 Titer) and Potential Impact Factors Among Subjects Whose Week 28 Antibody Results Are Within Week 28 Visit Window.|The Log10 titer at Week 28 was used as the quantitative continuous vaccine response.|Week 28|The data for this analysis included those who had a week 28 hepatitis B antibody titer and the week 28 visit window was no more than 8 weeks after the second vaccination (as treated population).||Participant|||Number
705445|NCT00107042|Primary|Safety and Tolerability of Vaccine Regimens of Recombivax and Twinrix: Serious Adverse Events (SAE)(Number of Subjects With >= 1 SAE)|Frequency Distribution of SAE by Study Arm and Preferred Term. The safety and tolerability of each vaccine was assessed by measuring reactogenicity. The reactions were coded as “Any” vs. “None”. The number of participants with at least one SAE is reported.|Week 12, Week 24, Week 28, Week 76|The safety and tolerability of each vaccine was assessed and reported among all enrolled participants (per-protocol) after baseline. The data presented are cumulative for events identified at each time point.||participants|||Number
705446|NCT00107042|Primary|Safety and Tolerability of Vaccine Regimens of Recombivax and Twinrix (Number of Participants With >=1 Adverse Event (AE))|Frequency Distribution of AEs by Study Arm and Preferred Term. The safety and tolerability of each vaccine was assessed by measuring reactogenicity. The reactions were coded as “Any” vs. “None”. In summarizing the distribution of AEs, the number of subjects with at least one event by preferred term and study arm were reported.|Week 12, Week 24, Week 28, Week 76|The safety and tolerability of each vaccine was assessed and reported among all enrolled participants (per-protocol) after baseline at each visit visit. The data presented are cumulative for events identified at each time point.||participants|||Number
705447|NCT00107042|Secondary|Quantitative Vaccine Response|The Log10 titer was used as the quantitative vaccine response.|Week 28|Subjects who had a wk 28 Hep B a'body titer and was no more than 8 wks after the 2nd vaccination were included. 1 subject was missing wk 28 titer. The a'body at week 48 was positive, so subject was treated as a responder for the binary measure. For the continuous a'body titer, the exact number could not be assumed; subject was treated as missing.||Log10 titer (mIU/ml)||Standard Deviation|Mean
705448|NCT00107042|Primary|Qualitative Seroresponsiveness to Hepatitis B Surface Antigen|"Seroresponsiveness to Hepatitis B Surface Antigen is defined as follows:
Responder: serum antibody level is greater than or equal to 10 mIU/mL. Non-responder: serum antibody level is less than 10 mIU/mL."|Week (Wk) 28 (One month after the second immunization)|Participants were included if they were vaccinated at least once (Intent-to-Treat)||Participants|||Number
705450|NCT00107120|Secondary|Clinical Global Impressions - Improvement|Clinical Global Impressions - Improvement score at the end of week 8. The scale rates improvement or worsening of patient mental health relative to baseline on a scale from 1 (very much improved) to 7 (very much worse).|CGI-I score at the end of Week 8|The Intent-To-Treat Population was used. The Last Observation Carried Forward (LOCF) technique was used to impute missing data.||Score on scale||Standard Error|Mean
705451|NCT00107120|Primary|Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score|Change from baseline to week 8 in Children's Depression Rating Scale total score. The scale measures 17 depressive symptoms, of which 3 are rated 1-5 and 14 are rated 1-7 (1 = no symptom difficulties; 5 or 7 = severe clinically significant difficulties) for a total score range of 17-113.|Baseline to end of week 8|Efficacy analyses used Intent-To-Treat Population, which consisted of all patients who received at least 1 dose of double-blind study drug & who had at least 1 post-baseline assessment of the CDRS-R. LOCF technique was used to impute missing data. 1 escitalopram pt. did not have a post-baseline CDRS-R total score.||Change in total score at endpoint||Standard Error|Mean
705452|NCT00107172|Secondary|DLCO% Measured at Baseline and Month 3|"Pulmonary function tests included percentage predicted carbon
> monoxide diffusing capacity of the lung (DLCO%) at baseline and month 3 were compared between arms."|3 months|All participants with complete pulmonary function test data at baseline and month 3.||Percentage of Predicted||Full Range|Median
705453|NCT00107172|Secondary|FEV1% Measured at Baseline and Month 3|Pulmonary function tests included percentage predicted forced expiratory volume in 1 second (FEV1%) at baseline and month 3 were compared between arms|3 months|All participants with complete pulmonary function test data at baseline and month 3.||Percentage of Predicted||Full Range|Median
705454|NCT00107172|Secondary|Dyspnea as Measured Using SOBQ at Baseline, Months 3, Months 12 and 24|Dyspnea was evaluated using the University of California, San Diego Shortness of Breath Questionnaire (SOBQ). It consists of 24-item on a scale of 0 to 5 with 0=not at all and 5=maximal or unable to do because of breathlessness. The total scores was calculated by summation of the 24 items scores and transformed into 0-100, with 0= poor quality of life , and 100= excellent quality of life..|24 months|Participants who met the eligibility criteria and had SOBQ data at baseline, month 3, 12 or 24.||units on a scale||Full Range|Median
705455|NCT00107172|Secondary|Global QOL as Measured Using SF36 at Baseline, Month 3, 12 and 24|Short-form health survey (SF36) consist of 36 items, where scores can be reported as 8 domains of functional health and well-being, or transformed into a physical component summary (PCS) score and a mental component summary (MCS) score. Standardized scores of SF36 PCS and MCS scores were calculated using the mean, SD, and scoring coefficients from the US general population. The standardized scores were then adjusted for age and gender using the mean and SD of the US general population according to age and gender grouping, and employing a linear transformation. Scores <50 indicate below-average health status.|24 months|Participants who met the eligibility criteria and had SF 36 data at baseline, month 3, 12 or 24.||units on a scale||Full Range|Median
705456|NCT00107172|Secondary|Number of Participants Reported Grade 3+ Respiratory Adverse Events Within 90 Days After Sublobar Resection|The respiratory AE included adult respiratory distress syndrome, aspiration, bronchospasm, bronchostenosis, dyspnea, hypoxia, pleural effusion, pneumonitis, chest tube drainage or leak, prolonged intubation, pulmonary-other, and pneumonia as defined by the CTCAE version 3.0.|90 days|All Intent-to-Treat (ITT) participants.||participants|||Number
705457|NCT00107172|Secondary|Number of Participants Reported Grade 3+ Adverse Events Within 90 Days After Sublobar Resection|Adverse Events were assessed via the Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.|90 days|All Intent-to-Treat (ITT) participants.||participants|||Number
705458|NCT00107172|Secondary|Mortality Rates at 30- and 90-day After Sublobar Resection||90 days|All Intent-to-Treat (ITT) participants||percentage of participants|||Number
705459|NCT00107172|Secondary|Number of Participants Reported Distant Recurrence at 3 Years|Distant recurrence was defined as the recurrence within contralateral lobe, contralateral mediastinal (N3) nodes or distant > metastatic disease (other organs).|3 years|All intent-to-treat participants.||participants|||Number
705460|NCT00107172|Secondary|Number of Participants Reported Regional Recurrence at 3 Years|Regional recurrence was defined as the recurrence within another lobe or pleura on the same side as the resection, or the ipsilateral mediastinal (N2) nodes.|3 years|All intent-to-treat participants.||participants|||Number
705461|NCT00107172|Secondary|Number of Participants Reported Local Recurrence at 3 Years|Local recurrence was defined as the recurrence within the same lobe or hilum (N1 nodes), or at the staple line after treatment effects such as scarring have subsided.|3 years|All intent-to-treat participants.||participants|||Number
705462|NCT00107172|Secondary|Overall Survival (OS)|OS was defined as the time from randomization to death due to any cause.|Up to 5 years|All intent-to-treat (ITT) participants||years||95% Confidence Interval|Median
705463|NCT00107172|Primary|Time to Local Recurrence|Local recurrence included the recurrence within the same lobe or hilum (N1 nodes), or progression at the staple line after treatment effects such as scarring have subsided. Time to local recurrence was censored 1) at the time of a distant recurrence, 2) at the last follow-up time when a patient died within 3 years of randomization without a local recurrence or 3) at 3 years follow-up if the patient remains alive 3 years post-randomization without a local recurrence.|Up to 3 years|All intent-to-treat (ITT) participants.||years||95% Confidence Interval|Median
705464|NCT00107198|Secondary|Grade 3 or 4 Toxicity||Any time during chemoradiotherapy, up to the end of 3-cycles of AV-PC induction. Each cycle is 21 days.|Eligible patients beginning AV-PC.||Participants|||Number
705465|NCT00107198|Secondary|Cure by AV-PC x 3 or AV-PC x 3 + IFRT for Stage I Unresected, Stage I Resected Whose Disease Recurred, and Stage II Patients|To estimate the proportions of Stage I unresected, Stage I resected (whose disease has recurred after observation), and Stage II LPHD patients who can be cured with AV-PC x 3, with IFRT for those who are not in a CR after chemotherapy.|At 5 years|Of 188 patients enrolled, five ineligible patients were excluded. 136 patients received upfront AV-PC with or without RT per protocol. Of these 135 achieved CR with AV-PC and avoided RT. The median follow up among the 121 censored patients is 62.2 months (range 3.4-104.5).||Probability participants||95% Confidence Interval|Number
705917|NCT00113087|Secondary|Neurodevelopmental Status (FSII)|Functional status II (Revised) Total Score. Scale ranges up to 100.00, the higher the better. The score presents an instrument for assessing health status for children surviving long term with chronic physcial disorders.|at 14 months of age|ITT, no imputation||units on a scale||Inter-Quartile Range|Median
705466|NCT00107198|Secondary|Cure by Surgery Alone in Stage I Resected Patients|To estimate the proportion of Stage I patients (with a single involved lymph node that is totally resected) who can be cured with surgery alone.|At 2 years|Of 188 patients enrolled, five ineligible patients were excluded. 52 patients with Stage IA, single node LPHL were enrolled with a confirmed total resection (TR). The median follow up among the 39 censored patients is 56.3 months (range 3.9-107.4).||Probability participants||95% Confidence Interval|Number
705467|NCT00107198|Secondary|Event-free Survival|Failure includes one of the following occurrences as a first event: relapse/progression or second malignancy from enrollment.|At 5 years|Of 188 patients enrolled, five ineligible patients were excluded from this analysis. 183 patients are included. The median follow-up time for the 155 censored patients is 61.2 months (range 0.03-107.4).||Probability participants||95% Confidence Interval|Number
705468|NCT00107198|Primary|Failure-free Survival (FFS)|The time to a treatment (strategy) failure, where failure includes one of the following occurrences as a first event: disseminated disease (> Stage I/II) progression or recurrence at any time, local disease progression or recurrence anytime during or after treatment with AV-PC +/- IFRT, occurrence of a second malignant neoplasm, death from any cause.|At 5 years|Of 188 patients enrolled, five ineligible patients and five patients who did not receive the upfront chemotherapy +/- RT per protocol were excluded from this analysis. 178 patients are included. The median follow-up for the 164 censored patients is 61.2 (range 3.5-107.4) months.||Probability participants||95% Confidence Interval|Number
705469|NCT00107276|Secondary|Toxicity|Number of patients for whom Grade 3 or higher toxicity observed during treatment. Only adverse events that are possibly, probably or definitely related to study drug are reported.|Patients assessed after each 21-day cycle for 8 cycles (24 weeks of treatment)|Eligible patients evaluable for toxicity assessment (one eligible patient who was removed from treatment due to disease progression less than 3 weeks after registration is not evaluable for toxicity assessment)||Participants|||Number
705470|NCT00107276|Secondary|Progression-free Survival and Overall Survival|"Progression-Free Survival: From date of registration to time of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free are censored at last date of contact.
Overall Survival: From date of registration to date of death due to any cause. Patients last known to be alive are censored at last date of contact.
Progression is 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed and/or unequivocal progression of non-measurable disease and/or appearance of new lesion/site or death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration is global deterioration of health status requiring discontinuation of treatment without objective evidence of progression."|two years|All eligible patients||months||95% Confidence Interval|Median
705471|NCT00107276|Primary|Response Rate (Complete and Partial, Confirmed and Unconfirmed)|Complete Response (CR) is complete disappearance of all measurable and non-measurable disease. No new lesions, no disease related symptoms. Normalization of markers and other abnormal lab values. Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration. Progression is 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed and/or unequivocal progression of non-measurable disease and/or appearance of new lesion/site or death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration is global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.|Patients assessed at least every six weeks while on protocol treatment|Eligible patients with RECIST measurable disease||participants|||Number
705472|NCT00107315|Secondary|Toxicity|"Number of participants with an adverse event.
Please refer to the adverse event reporting for more detail."|1 year|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.|||||
705473|NCT00107315|Secondary|Median Survival||1 year|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.|||||
705474|NCT00107315|Secondary|Response Rate|Overall Response (OR) = CR + PR.|1 year|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.|||||
705475|NCT00107315|Primary|Time to Progression||1 year|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.|||||
705476|NCT00107380|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)|Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.||Participants|||Number
705477|NCT00107380|Primary|Response Rate (Complete, Complete Unconfirmed, and Partial)|Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.|6 months|All eligible patients who started treatment were included in the analysis||participants|||Number
705514|NCT00107783|Secondary|Change in Timed Get up and go|Change from baseline of timed get up and go at 36 months. In timed get up and go, the patient is asked to stand up from a standard chair and walk a distance of 3 meters, turn around and walk back to the chair and sit down. The examiner measures the time it takes for the patient to perform this series of tasks.|Measured at baseline and at 36 months|In the control group, two patients who dropped out for personal reasons were not included in this analysis, and in the treated group one patient who died was not included in this analysis.||seconds||Standard Deviation|Mean
705478|NCT00107380|Primary|Progression-free Survival (PFS) at 2 Years|Clinical responses were evaluated according to International Workshop NHL criteria (Cheson et al, 1999). Progression disease was defined as if a (CR, CRU) was not achieved at a previous assessment, a 50% increase in the SPD of target measurable lesions over the smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline. Appearance of a new lesion/site. Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided). Death due to disease without prior documentation of progression. PFS is measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.|0-2 years|All eligible patients who started treatment were included in the analysis||percentage of participants||95% Confidence Interval|Number
705479|NCT00107536|Secondary|Expression Profile and Mutations of Genes Critical for EGFR and ERBB2 Signaling Pathways||Up to 3 years|||patients with mutations|||Number
705480|NCT00107536|Secondary|Target-EGFR/EGFR-P Protein Expression|EGFR (exons 18-21)|Up to 3 years|||patients with somatic mutations|||Number
705481|NCT00107536|Secondary|Overall Survival||up to 12.6 months|||months||95% Confidence Interval|Median
705482|NCT00107536|Secondary|Median Overall Survival||Up to 3 years|||months||95% Confidence Interval|Median
705483|NCT00107536|Secondary|Toxicity Profile Assessed Using NCI CTCAE Version 3.0|Percentage of patients with Adverse events accordng to NCI CTCAE version 3.0|Up to 3 years|All 26 patients were evaluable for toxicity analysis.||percentage of patients|||Number
705484|NCT00107536|Secondary|Progression-free Survival||up to 6 months|||months||95% Confidence Interval|Median
705485|NCT00107536|Primary|Proportion of Patients Demonstrating Objective Response (PR+CR) as Defined by RECIST|PR (Partial Response) definded as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. CR (Complete Response) is defined as the disappearance of all target lesions.|Up to 3 years|Only 25 patients were evaluable for response (1 patient passed away before staging).||patients|||Number
705486|NCT00107575|Primary|Smoking Abstinence at 2 Weeks|7 days of smoking abstinence confirmed biochemically at 2 weeks|2 weeks|||Participants|||Number
705487|NCT00107575|Primary|Smoking Abstinence at 8 Weeks|7 days of smoking abstinence confirmed biochemically at 8 weeks|8 weeks|||Participants|||Number
705488|NCT00107575|Primary|Smoking Abstinence at 16 Weeks|7 days of smoking abstinence confirmed biochemically at 16 weeks|16 weeks|||Participants|||Number
705489|NCT00107575|Secondary|Alcohol Drinks Consumed Per Week Over a 2-week Period|Average number of standard alcoholic drinks consumed per week over each 2-week period across the 26 weeks of follow-up as assessed by the Timeline Followback Interview. Standard alcoholic drink is defined as 12 oz of beer, 5 oz of wine, or 1.5 ounces of liquor.|At 2, 8, 16, and 26-week follow-ups|The number of participants analyzed reflects the number of participants who provided at least some valid data on the Timeline Followback Interview||drinks||Standard Deviation|Mean
705490|NCT00107575|Primary|Smoking Abstinence at 26 Weeks|7 days of smoking abstinence confirmed biochemically at 26 week post quit attempt|26 weeks|For analyses of smoking outcomes, missing data were considered smoking. However, at 26 weeks, 2 participants in ST-BI had died and therefore their data was left as missing for this period.||participants|||Number
705491|NCT00107614|Primary|Response Rates to a Brief Remission Induction Treatment With One or Two Courses of Melphalan-based High-dose Treatment (HDT)|To evaluate the complete and partial response rates, defined in a strict manner, to a brief remission induction treatment with one or two courses of melphalan-based high-dose treatment (HDT) in symptomatic patients with Waldenström’s Macroglobulinemia (WM), either untreated or previously treated.|3 years|||participant|||Number
705492|NCT00107653|Secondary|Number of Participants With Premature Withdrawals Due to Adverse Events or Laboratory Abnormalities|The table below includes participants with premature withdrawals due to adverse events or laboratory abnormalities.|Up to Week 72|The Safety Population included participants who received at least 1 dose of any study drug and had at least 1 post baseline safety assessment.||Participants|||Number
705493|NCT00107653|Secondary|Number of Participants With Marked Abnormal Laboratory Parameters|The below table includes participants with marked abnormal lab parameters. Standard reference ranges include: Hematocrit: (fraction) 0.37 - 0.49, Hemoglobin 130 – 180 g/L, Platelets 150 – 350 10^9/L, White Blood Cell (WBC) 4.5 - 11.0 10^9/L, Lymphocytes 1.00 - 4.80 10^9/L, Neutrophils 1.80 - 7.70 10^9/L, Aspartate aminotransferase (AST) 0-40 U/L, ALT 0 – 55 U/L, Total bilirubin 0 – 17 μmol/L, Thyroxine T4 58 – 140 nmol/L, Thyroid Stimulating Hormone (TSH) 0.0 - 5.0 million units (mU)/L, Albumin 35.0 - 55.0 g/L, Chloride 100 – 108 mmol/L, Calcium 2.10 - 2.60 mmol/L, Phosphate 0.84 - 1.45 mmol/L, Uric acid 214 – 506 μmol/L.|Up to Week 72|The Safety Population included participants who received at least 1 dose of any study drug and had at least 1 post baseline safety assessment. 'n'=number of evaluable participants available at specified time point.||Participants|||Number
705494|NCT00107653|Secondary|Number of Participants With Any Adverse Events and Serious Adverse Events|An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An adverse event could therefore be any unfavorable or unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Pre-existing conditions that worsened during the study were reported as adverse events. A serious adverse event (SAE) was any untoward medical occurrence that at any dose results in death, is life threatening, requires hospitalization or prolongation of hospitalization, or results in disability/incapacity, or congenital anomaly/birth defect.|Up to Week 72|The Safety Population included participants who received at least 1 dose of any study drug and had at least 1 post baseline safety assessment.||Participants|||Number
705515|NCT00107783|Secondary|Change in Functional Reach Assessment|Change from baseline of functional reach assessment at 36 months. Functional reach assessment measures the difference between the length of a person's outstretched arm and their maximal reach forward, while maintaining balance.|Measured at baseline and at 36 months|In the control group, two patients who dropped out for personal reasons were not included in this analysis, and in the treated group one patient who died was not included in this analysis.||cm||Standard Deviation|Mean
705495|NCT00107653|Secondary|Mean Change in 36-item Short Form Health Survey Total and Domain Scores From Baseline at Week 48 and 72|The 36-item Short Form Health Survey (SF-36) is a 36-item self-report questionnaire that includes 8 domain scales The 8 domains are incorporated into 2 components: mental and physical. The mental component (MC) includes social functioning, role limitations-emotional, mental health, and vitality. The physical component (PC) includes physical functioning, role limitations-physical, bodily pain, and general health perception. Raw domain scores are transformed to a 0 to 100 scale, [0=worst score (or quality of life) and 100=best score]. Two summary scale scores were computed based on weighted combinations of the 8 domain scores (Physical and the Mental Component) where no minimum or maximum score; higher score indicate better health status. The difference between study groups in change from baseline in SF-36 score at week 48 and 72 was analysed.|Baseline (Week 0), Week 48 and Week 72|ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). Analysis was performed for ITT participants with paired biopsy. 'n'=number of evaluable participants available at specified time point.||Score on a scale||Standard Error|Mean
705496|NCT00107653|Secondary|Mean Change in Fatigue Severity Scale Score and Fatigue Severity Scale Score Item 10 Visual Analog Scale Score From Baseline at Week 48 and Week 72|The Fatigue Severity Scale (FSS) is a 10-item self-report questionnaire designed to assess tiredness, lack of energy, or total body give-out. Participants were to react to nine statements regarding fatigue over the previous 2 weeks, each on a scale (1 = completely agree, 7 = completely disagree). The FSS is the average of the scores on the 9 questions; ranging from 1-7, with lower scores indicating less fatigue. In addition, participants were to react to how much fatigue they had in the past 2 weeks by marking on a visual analogue scale (VAS) labelled at one end with “no fatigue” (‘0’ being the best) and at the other end with “greater fatigue” (‘100’ being the worst). Longer distance on the scale from “no fatigue” indicated “greater fatigue”. FSS values are presented based on questionnaire and visual analog scale. FSS values at week 48 and 72 are presented based on questionnaire and visual analog scale.|Baseline (Week 0), Week 48 and Week 72|ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). 'n'=number of evaluable participants available at specified time point.||Score on a scale||Standard Error|Mean
705497|NCT00107653|Secondary|Percentage of Participants With Non-zero Nonalcoholic Steatohepatitis Score|The Nonalcoholic Steatohepatitis (NASH) included an assessment of sinusoidal fibrosis, Mallory bodies, and hepatocyte ballooning (HB). Grading categories for the NASH scales were as: Sinusoidal fibrosis: 0 = absent; 1 = involvement of some lobules; 2 = involvement of most lobules, without diffuse interstitial sinusoidal collagen deposition; 3 = Involvement of most or all lobules;, with diffuse interstitial fibrosis involving some or most of the lobules Mallory bodies: 0 = absent; 1 = involvement of some lobules; 2 = involvement of most lobules; 3= involvement of most or all lobules; and Hepatocyte ballooning: 0 = absent; 1 = involvement of some lobules; 2 = involvement of most lobules; 3= involvement of most or all lobules.|At Week 72|ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). Analysis was performed for ITT participants with paired biopsy.||Percentage of participants|||Number
705498|NCT00107653|Secondary|Percentage of Participants With Improved, Stable and Worsened Fat Score From Baseline to Week 72|Fat scores are categorised as Improved: > 1 category decrease in fat scale; stable: no change in fat scale; worsened: >= 1 category increase in fat scale.|From Baseline (Week 0) to Week 72|ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). Analysis was performed for ITT participants with paired biopsy.||Percentage of participants|||Number
705499|NCT00107653|Secondary|Mean Change From Baseline in Fat Score at Week 72|Grading categories for the fat scale were as follows: 1 = <5% hepatocytes; 2 = 6 – 33% hepatocytes; 3 = 34 – 66% hepatocytes; 4 = 67 - 100% hepatocytes.|From Baseline (Week 0) to Week 72|ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). Analysis was performed for ITT participants with paired biopsy.||Score on a scale||Standard Error|Mean
705500|NCT00107653|Secondary|Percentage of Participants With Improved, Stable, and Worsened METAVIR Fibrosis Score|METAVIR fibrosis score is categorized as, Improved: >= 1 category decrease in activity score; stable: no change in activity score; worsened: >= 1 category increase in activity score.|At Week 72|ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). Analysis was performed for ITT participants with paired biopsy.||Percentage of participants|||Number
705501|NCT00107653|Secondary|Percentage of Participants With Improved, Stable, and Worsened METAVIR Activity Score|METAVIR activity scale included activity defines as, Improved: >= 1 category decrease in activity score; stable: no change in activity score; worsened: > = 1 category increase in activity score.|At Week 72|ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). Analysis was performed for ITT participants with paired biopsy.||Percentage of participants|||Number
705502|NCT00107653|Secondary|Mean Change From Baseline in Activity and Fibrosis Scores Based on METAVIR Activity at Week 72|METAVIR activity scores are categorised as histological activity (A) 0 = none; A1 = mild; A2 = moderate; A3 = severe where ‘0’ being ‘No activity’ and ‘3’ being ‘the sever activity’. Changes in liver inflammation defined as Improved: Participants whose METAVIR activity score at up to Month-72 decreases by 1 or more units compared to baseline; stable: Participants whose METAVIR activity score at up to Month-72 is the same as the baseline score; worsened: Participants whose METAVIR activity score at up to Month-72 increases by 1 or more units compared to baseline. METAVIR fibrosis scores are categorised as fibrosis (F) 0 = no fibrosis; F1 = without septa; F 2 = with septa; F3 = many septa; F4 = cirrhosis where; ‘0’ being the best and ‘4’ being the worst. Decrease in score from baseline indicates improvement. The difference between study groups in change from baseline in activity and fibrosis scores based on METAVIR at week 72 was analysed.|From Baseline (Week 0) to Week 72|ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). Analysis was performed for ITT participants with paired biopsy.||Score on a scale||Standard Error|Mean
705503|NCT00107653|Secondary|Percentage of Participants With Improved, Stable and Worsened ISHAK Fibrosis Score|Overall ISHAK Fibrosis Score is defined as Improved: >= 1 category decrease in fibrosis scale; Stable: no change in fibrosis scale; Worsened: >1 category increase in fibrosis scale.|At Week 72|ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). Analysis was performed for ITT participants with paired biopsy.||Percentage of participants|||Number
705504|NCT00107653|Secondary|Mean Change From Baseline in Fibrosis Score Based on ISHAK at Week 72|ISHAK Histological Activity Index (HAI) activity response is defined as a decrease from baseline of at least 2 points (≥2 points drop from baseline) score at week 72. Baseline prognostic factors in the original model include ethnicity, sex, age, baseline ALT quotient, baseline HCV-RNA level, and ISHAK fibrosis and activity scores at baseline. ISHAK modified HAI fibrosis scale by fibrosis grading category as F0= no fibrosis; F1= some portal areas; F2= most portal areas; F3= bridging fibrosis; F4= bridging and portal to central; F5 = marked bridging; F6 = Cirrhosis; where ‘0’ being the best and ‘6’ being the worst. Decrease in score from baseline indicates improvement. The difference between study groups in change from baseline in ISHAK modified HAI activity score at week 72 was analysed.|From Baseline (Week 0) to Week 72|ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). Analysis was performed for ITT participants with paired biopsy. 'n'=number of evaluable participants available at specified time point.||Score on a scale||Standard Error|Mean
705505|NCT00107653|Secondary|Mean Change From Baseline in ISHAK HAI Activity (Necroinflammatory) at Week 72|ISHAK modified HAI activity (necroinflammatory) score is a total score of P/B necrosis + confluent necrosis + focal necrosis + portal inflammation (maximum score for each Participant = 18). Where P/B necrosis grading as 0 = absent; 1 = mild; 2 = mild/moderate; 3 = moderate; 4 = severe; Confluent necrosis as 0 = absent; 1 = focal; 2 = zone 3 some areas; 3 = zone 3 most areas; 4 = zone 3 occasional portal; 5= zone 3 multiple; 6= panacinar necrosis and Focal necrosis as 0: absent; 1: <= 1 focus; 2: 2 to 4 foci; 3: 5 to 10 foci; 4: > 10 foci; Portal Inflammation: 0 = none; 1 = mild; 2 = moderate; 3 = moderate/marked; 4 = marked/all portal. The difference between study groups in change from baseline in ISHAK modified HAI activity score at week 72 was tested using an analysis of covariance (ANCOVA) model with ethnicity and baseline ISHAK HAI score as the fixed effects.|From Baseline (Week 0) to Week 72|ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). Analysis was performed for ITT participants with paired biopsy.||Score on a scale||Standard Error|Mean
705506|NCT00107653|Secondary|Percentage of Participants With ISHAK Histological Activity Index Response|ISHAK Histological Activity Index (HAI) activity response is defined as a decrease from baseline of at least 2 points (≥2 points drop from baseline) in the ISHAK modified HAI (necroinflammatory) score at week 72. ISHAK modified HAI activity (necroinflammatory) score is a total score of periportal ± bridging (P/B) necrosis + confluent necrosis + focal necrosis + portal inflammation (maximum score for each participant = 18). Where P/B necrosis grading as 0 = absent; 1 = mild; 2 = mild/moderate; 3 = moderate; 4 = severe; Confluent necrosis grading as 0 = absent; 1 = focal; 2 = zone 3 some areas; 3 = zone 3 most areas; 4 = zone 3 occasional portal; 5 = zone 3 multiple; 6 = panacinar necrosis and Focal necrosis grading as 0: absent; 1: < = 1 focus; 2: 2 to 4 foci; 3: 5 to 10 foci; 4: > 10 foci; Portal Inflammation grading: 0 = none; 1 = mild; 2 = moderate; 3 = moderate/marked; 4 = marked/all portal.|At Week 72|ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). Analysis was performed for ITT participants with paired biopsy.||Percentage of participants|||Number
705507|NCT00107653|Secondary|Percentage of Participants With Biochemical Response|Biochemical response was defined as normal serum alanine transaminase (ALT) measurement. For ALT measurement the normal range is 5-37 IU/L.|At Weeks 4, 12, 24, 48, 60 and 72|ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus).||Percentage of participants|||Number
705508|NCT00107653|Secondary|Change From Baseline in HCV-RNA Log10 Titers Over the Period Of Time|The table below shows HCV-RNA log10 titers change from baseline values by study week and by study group. Analysis was performed for participants with a baseline and at least 1 post-baseline HCV-RNA assessment. HCV-RNA quantitation was performed using Roche High Pure System/COBAS® TaqMan® HCV Monitor Test. HCV-RNA measurement lower limit of detection was 28 IU/mL.|From Baseline (Week 0) to Weeks 4, 12, 24, 48, 60 and 72|ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). 'n'=number of evaluable participants available at specified time point.||Log10 IU/mL||Standard Error|Least Squares Mean
705509|NCT00107653|Secondary|Percentage of Participants With Early Virologic Response at Week 12|Percentage of participants with an early virologic response defined as an HCV-RNA >=2 log10 drop from baseline or undetectable HCV-RNA measurement at Week 12 (lower limit of detection 28 IU/mL).|At Week 12|ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus).||Percentage of participants|||Number
705510|NCT00107653|Secondary|Percentage of Participants With Early Virologic Response at Week 4|Percentage of participants with an early virologic response defined as an HCVRNA >=1 log10 drop from baseline or undetectable HCV-RNA measurement at Week 4 (lower limit of detection 28 IU/mL).|At Week 4|ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus).||Percentage of participants|||Number
705511|NCT00107653|Secondary|Percentage of Participants Achieving Virologic Response|Percentage of participants achieving a virologic response defined as an undetectable HCV-RNA measurement (HCV-RNA <28 IU/mL by Roche High Pure System/COBAS TaqMan HCV Test)|At Weeks 4, 12, 24, 48, 60, and 72|ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus).||Percentage of participants|||Number
705512|NCT00107653|Primary|Percentage of Participants With Sustained Virologic Response at Week 72|Sustained Virologic Response (SVR) is defined as percentage of participants with an undetectable hepatitis C virus-RNA (HCV-RNA) measurement (<28 International Unit (IU)/millilitre (mL)) assessed 24 weeks post-treatment (week 72) which was assessed by Roche High Pure System/COBAS TaqMan HCV Test.|At Week 72|Intent-to-Treat (ITT) Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus).||Percentage of participants|||Number
705513|NCT00107783|Secondary|Change in 6 Minute Walk Test (6MWT)|Change from baseline of the 6MWT at 36 months. The 6MWT measures the distance that a patient can quickly walk on a flat hard surface in a period of six minutes.|Measured at baseline and at 36 months|In the control group, two patients who dropped out for personal reasons were not included in this analysis, and in the treated group one patient who died was not included in this analysis.||ft||Standard Deviation|Mean
705563|NCT00110890|Secondary|Number of Participants With Mean Ca x P < 55 mg^2/dL^2|Number of participants with mean calcium x phosphorus (Ca x P) < 55 mg^2/dL^2 during the efficacy assessment phase|Efficacy Assessment Phase (weeks 17 to 23)|Full Analysis Set, composed of all randomized participants with imputation using modified last value carried forward (mLVCF)||Participants|||Number
705516|NCT00107783|Secondary|Change in Schober's Test|Change from baseline of Schober's test at 36 months. Schober's test measures a patient's ability to flex his/her lower back. The examiner makes a mark at L5 (fifth lumbar vertebra) and places one finger 5 cm below and another finger 10 cm above this mark. The patient is asked to touch his/her toes. The examiner measures the increase in distance between the two fingers.|Measured at baseline and at 36 months|In the control group, two patients who dropped out for personal reasons were not included in this analysis, and in the treated group one patient who died was not included in this analysis.||cm||Standard Deviation|Mean
705517|NCT00107783|Primary|Change in Total ROM Worse Hip.|Change from baseline in the total (external + internal) hip range of motion (ROM) in the worse hip at 36 months.|Measured at baseline and at 36 months|Intention to treat.||degrees||Standard Deviation|Mean
705518|NCT00107900|Secondary|Change From Baseline for Activated Partial Thromboplastin Time (aPTT) Results|Intent to Treat (ITT) population|end of treatment|ITT population||seconds||Standard Deviation|Mean
705519|NCT00107900|Secondary|Change From Baseline for International Normalized Ratio (INR) Results|Intent to Treat (ITT) population|end of treatment|ITT population||INR ratio||Standard Deviation|Mean
705520|NCT00107900|Secondary|Change From Baseline for Prothrombin Time (PT) Results|Intent to Treat (ITT) population|end of treatment|ITT population||seconds||Standard Deviation|Mean
705521|NCT00107900|Primary|Prevention of Venous Thromboembolism (VTE)|"The primary efficacy endpoint was the proportion of subjects who experienced at least one of the thromboembolic events listed below during the period from the start of study treatment to the venography at the end of study treatment (approximately 2 weeks post surgery).
Confirmed deep vein thrombosis ( both proximal and distal ) as assessed by unilateral or bilateral ascending contrast venograms 7 to 10 days following surgery Symptomatic and objectively proven Pulmonary Embolism (PE) prior to venography Symptomatic and objectively proven Deep Vein Thrombosis (DVT) prior to venography"|2 weeks|modified ITT population||percentage of patients with event||90% Confidence Interval|Number
705522|NCT00107952|Primary|Clinical Response|"Clinical Response: Categorical (Cured, Failed or Indeterminate)
Failure is at least one of the following: Persistence or progression of signs and symptoms of pneumonia that still require antibiotic therapy; Termination of study med due to “lack of efficacy”; Death on or after Day 3 attributable to primary infection
Cure: Signs and symptoms of pneumonia improved to the point that no further antibiotics for pneumonia were required, and baseline radiographic findings improved or did not progress.
Indeterminate: Inability to determine outcome"|7 - 14 days following end of antibiotic treatment|||participants|||Number
705523|NCT00107978|Primary|Clinical Response|The Clinical Response for each patient was determined by the investigator by assessing the patient's clinical signs & symptoms compared with the Baseline evaluation. Cure: resolution of signs and symptoms associated with the skin infection present at study admission such that no further antibiotic therapy was necessary; Not Cured: inadequate response to study therapy; Indeterminate: unable to determine outcome.|7 to 14 days after the last antibiotic dose|Data for the all-treated population (AT) are presented. The AT and clinically evaluable (CE) populations were considered co-primary.||patients|||Number
705524|NCT00107991|Secondary|Dermatology Life Quality Index Score (DLQI)|"The DLQI is a dermatology-specific health-related quality of life measure. The effect on a patient's life is as follows: 0-1=none; 2-5=small; 6-10=moderate; 11-20=very large; and 21-30=extremely large. Responders were defined as those who achieved a 50% improvement in the DLQI score.
Response rates were calculated as the percentage of participants achieving a response."|12 weeks|||Response Rate - % of participants||95% Confidence Interval|Number
705525|NCT00107991|Secondary|Patient's Pain Score|Patient's were asked to self-report their pain on a 100-mm visual analog scale (with 0 corresponding to no pain and 100 mm corresponding to severe pain). Responders were defined as those achieving at least a 50% reduction in pain score from baseline to week 12. Reponse rate was calculated as the percentage of patients classified as responders.|12 weeks|||Response Rate - % of participants||95% Confidence Interval|Number
705526|NCT00107991|Secondary|Patient Global Assessment|"The Patient Global Assessment asked patients to rate the extent of hidradenitis activity compared to when the patient started treatment with etanercept (day 0 of study). The scale included a selection of:
Much worse than before treatment Moderately worse (about 50% more disease activity) A little worse Same A little improved Moderately improved (about 50% reduction in disease activity) Much better than before treatment (no active disease or almost no active disease)"|12 weeks|||number of participants|||Number
705527|NCT00107991|Primary|Physician's Global Assessment Score - Response Rate (Percentage)|"Efficacy was measured using the Physician Global Assessment (PGA). Responders were classified as those achieving at least a 50% reduction on the Physician Global Assessment score at week 12 compared with baseline. A response rate was calculated as the percentage of patients that were classified as responders at 12-weeks.
PGA was scored at baseline and at 12 weeks on a 100-mm visual analog scale, with 0 indicating no disease and 100-mm indicating severe disease."|12 weeks|||Response Rate - % of participants||95% Confidence Interval|Number
705528|NCT00107991|Secondary|Number of Lesions (Response Rate - Percentage)|A physician assessed number of lesions as baseline and week 12. Responders were defined as those achieving at least a 50% reduction in number of lesions. A response rate was calculated as percentage of patients classified as responders.|12 weeks|||Response Rate - % of participants||95% Confidence Interval|Number
705529|NCT00108069|Secondary|Adverse Event Grades|The combined serious and non-serious adverse event Table describes count of patients whose highest grade adverse event for any CTC (common terminology criteria) term was related to study drugs for the GBM (Glioblastoma multiforme) and AG (Anaplastic glioma) cohorts.|7.5 years|Neither cohort completed planned accrual and are small in number separately. Additionally, the underlying histological grade would not affect toxicity. Therefore, these cohorts may be combined. The Table describes count of patients whose highest grade adverse event for any CTC (common terminology criteria) term was related to study drugs.||participants|||Number
705530|NCT00108069|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|7.5 years|||Participants|||Number
705564|NCT00110890|Secondary|Number of Participants With Mean Ca x P < 55 mg^2/dL^2 and iPTH ≤ 300 pg/mL|Number of participants with mean calcium x phosphorus (Ca x P) < 55 mg^2/dL^2 and intact parathyroid hormone (iPTH) ≤ 300 pg/mL during the efficacy assessment phase|Efficacy Assesment Phase (weeks 17-23)|Full Analysis Set, composed of all randomized participants with imputation using modified last value carried forward (mLVCF)||Participants|||Number
705531|NCT00108069|Primary|Response, Defined as Stable Disease or Objective (Partial or Complete) Response.|Complete response (CR) is complete disappearance of all measurable and evaluable disease. No new lesions. No evidence of non-evaluable disease. All measurable, evaluable and non-evaluable lesions and site must be assessed using the same techniques as baseline. Patients who respond must be on the same or decreasing doses of dexamethasone. Partial response (PR) is greater than or equal to a 50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable disease. No new lesions. All measurable and evaluable lesions and sites must be assessed using same techniques as baseline. Responders must be on the same decreasing doses of dexamethasone. Stable disease (SD) does not qualify for CR, PR, or progression (e.g., a 25% increase in the sum of products of all measurable lesions). The designation of stable/no response requires a minimum of 6 weeks duration. All measurable and evaluable sites must be assessed using the same techniques as baseline.|Patients were followed for an average of six weeks for assessment of response|Two patients were not able to complete follow-up neuroimaging to assess response due to clinical progression of disease.||Participants|||Number
705532|NCT00108082|Secondary|Model-adjusted Ratio to Baseline as Percentage Change From Baseline in Log Transformed Albumin Creatinine Ratio (ACR) at Month 12|Urinary ACR (micrograms per milligram) was determined at Baseline and after 12 months of treatment/Month 12. Percentage change from Baseline was based on log transformed data and was calculated as 100 x (exponent (exponent (mean change on log scale) - 1. [Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value.]|Baseline and Month 12 (If Month 12 data were not available, the LOCF was used)|All randomized participants who had a valid measurements at Baseline and Month 12 (LOCF)||percentage of change||95% Confidence Interval|Geometric Mean
705533|NCT00108082|Secondary|Percentage Change From Baseline in Log Transformed Lipid Parameters at Month 12|Plasma lipid concentrations (milligrams per deciliter) were measured at Baseline and after 12 months of treatment/Month 12. Percentage change from Baseline was based on log transformed data and calculated as 100 x (exponent(mean change on log scale) - 1). [Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value.]|Baseline and Month 12 (If Month 12 data were not available, the LOCF was used)|All randomized participants who had a valid measurements at Baseline and Month 12 (LOCF)||percentage of change||95% Confidence Interval|Geometric Mean
705534|NCT00108082|Secondary|Model-adjusted Ratio to Baseline as Percentage Change From Baseline in Log Transformed C-Reactive Protein (CRP) at Month 12|CRP concentration (milligrams per deciliter) was measured at Baseline and after 12 months of treatment/Month 12. Percentage change from Baseline was based on log transformed data and calculated as 100 x (exponent (mean change on log scale) - 1). [Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value.]|Baseline and Month 12 (If Month 12 data were not available, the LOCF was used)|All randomized participants who had a valid measurements at Baseline and Month 12 (LOCF)||percentage of change||95% Confidence Interval|Geometric Mean
705535|NCT00108082|Secondary|Model-adjusted Ratio to Baseline as Percentage Change From Baseline in Log Transformed B-type Natriuretic Peptide (BNP) at Month 12|BNP concentration (picagram per milliter) was measured at Baseline and after 12 months of treatment/Month 12. Percentage change from Baseline was based on log transformed data and was calculated as 100 x (exponent (mean change on log scale) -1) [Change is the Month 12 value (or value after 12 months of treatment) minus the Baseline value].|Baseline and Month 12 (If Month 12 data were not available, the LOCF was used|All randomized participants who had a valid measurements at Baseline and Month 12 (LOCF)||percentage of change||95% Confidence Interval|Geometric Mean
705536|NCT00108082|Secondary|Model-adjusted Mean Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Month 12|Systolic and Diastolic BP were measured at Baseline and after 12 months of treatment/Month 12. Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value.|Baseline and Month 12 (If Month 12 data were not available, the LOCF analysis, which includes data collected on or after Month 9 of treatment to Month 12 of treatment, was used)|All randomized participants who had a valid MRI at Baseline and Month 12 (LOCF on or after Month 9 to Month 12)||mmHg (millimeters of mercury)||Standard Error|Mean
705537|NCT00108082|Secondary|Model-adjusted Mean Change From Baseline in LV End Systolic and Diastolic Volumes and Ejection Fraction as Measured by Echocardiography at Month 12|LV End Systolic and Diastolic Volumes and Ejection Fraction were measured by echocardiography at Baseline and after 12 months of treatment/Month 12. Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value.|Baseline and Month 12 (If Month 12 data were not available, the LOCF analysis, which includes data collected on or after Month 9 of treatment to Month 12 of treatment, was used)|All randomized participants who had a valid echocardiogram at Baseline and Month 12 (LOCF on or after Month 9 to Month 12)||milliliters (mL)||Standard Error|Mean
705538|NCT00108082|Secondary|Model-adjusted Mean Change From Baseline in LV End Systolic and Diastolic Volumes and Ejection Fraction as Measured by MRI at Month 12|LV End Systolic and Diastolic Volumes and Ejection Fraction were measured by MRI at Baseline and after 12 months of treatment/Month 12. Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value. The ejection fraction is the fraction of the blood volume available at the end of diastole that is pumped out of the ventricules during systole.|Baseline and Month 12 (If Month 12 data were not available, the LOCF analysis, which includes data collected on or after Month 9 of treatment to Month 12 of treatment, was used)|All randomized participants who had a valid MRI at Baseline and Month 12 (LOCF on or after Month 9 to Month 12)||milliliters (mL)||Standard Error|Mean
705539|NCT00108082|Secondary|Mean Change From Baseline in LV Filling Parameters as Measured by MRI at Month 12|LV filling parameters, LV E-Volume and LV A-Volume, were measured by MRI at Baseline and after 12 months of treatment/Month 12. Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value. These filling parameters represent the volumes of blood filling the ventricle during the passive filling phase (E-volume) and the active filling phase caused by atrial contraction (A-volume).|Baseline and Month 12 (If Month 12 data were not available, the LOCF analysis, which includes data collected on or after Month 9 of treatment to Month 12 of treatment, was used)|All randomized participants who had a valid MRI at Baseline and Month 12 (LOCF on or after Month 9 to Month 12)||milliliters (mL)||Standard Error|Mean
710932|NCT00168844|Secondary|Change From Baseline in Eosinophils (Absolute)|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||10^9/L||Standard Deviation|Mean
705540|NCT00108082|Secondary|Model-adjusted Mean Change From Baseline in LV Mass as Measured by Echocardiography at Month 12|LV Mass was measured by echocardiography at Baseline and after 12 months of treatment/Month 12. Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value.|Baseline and Month 12 (If Month 12 data were not available, the LOCF analysis, which includes data collected on or after Month 9 of treatment to Month 12 of treatment, was used)|All randomized participants who had a valid echocardiogram at Baseline and Month 12 (LOCF on or after Month 9 to Month 12)||grams||Standard Error|Mean
705541|NCT00108082|Secondary|Model-adjusted Mean Change From Baseline in Left Ventricular Mass Indexed by Height (LVMIH) as Measured by Echocardiography at Month 12|LVMIH was measured by echogradiography at Baseline and after 12 months of treatment/Month 12. Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value.|Baseline and Month 12 (If Month 12 data were not available, the LOCF analysis, which includes data collected on or after Month 9 of treatment to Month 12 of treatment, was available)|All randomized participants who had a valid echocardiogram at Baseline and Month 12 (LOCF on or after Month 9 to Month 12)||g/m raised to 2.7 (g/(m^2.7))||Standard Error|Mean
705542|NCT00108082|Secondary|Model-adjusted Mean Change From Baseline in Left Ventricular Mass Indexed (LVMI) by Body Surface Area as Measured by Echocardiography at Month 12|LVMI was measured by echogradiography at Baseline and after 12 months of treatment/Month 12. Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value.|Baseline and Month 12 (If Month 12 data were not available, the LOCF analysis, which includes data collected on or after Month 9 of treatment to Month 12 of treatment, was used)|All randomized participants who had a valid echocardiogram at Baseline and Month 12 (LOCF on or after Month 9 to Month 12)||grams per meters squared (g/m^2)||Standard Error|Mean
705543|NCT00108082|Secondary|Model-adjusted Mean Change From Baseline in Left Ventricular (LV) Mass as Measured by MRI at Month 12|LV Mass was measured by MRI at Baseline and after 12 months of treatment/Month 12. Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value.|Baseline and Month 12 (If Month 12 data were not available, the LOCF analysis, which includes data collected on or after Month 9 of treatment to Month 12 of treatment, was used)|All randomized participants who had a valid MRI at Baseline and Month 12 (LOCF on or after Month 9 to Month 12)||grams (g)||Standard Error|Mean
705544|NCT00108082|Secondary|Model-adjusted Mean Change From Baseline in Left Ventricular Mass Indexed by Height (LVMIH) as Measured by MRI at Month 12|LVMIH was measured by MRI at Baseline and after 12 months of treatment/Month 12. Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value. LV mass depends on body size. One method of determining whether an individual has LV hypertrophy relates LV mass to height raised to a power of 2.7.|Baseline and Month 12 (If Month 12 data were not available, the LOCF analysis, which includes data collected on or after Month 9 of treatment to Month 12 of treatment, was used)|All randomized participants who had a valid MRI at Baseline and Month 12 (LOCF on or after Month 9 to Month 12)||g/m raised to 2.7 (g/(m^2.7))||Standard Error|Mean
705545|NCT00108082|Primary|Model-adjusted Mean Change From Baseline in Left Ventricular Mass Indexed (LVMI) by Body Surface Area as Measured by Magnetic Resonance Imaging (MRI) at Month 12|LVMI was measured by MRI at Baseline and after 12 months of treatment/Month 12. A reduction in left ventricular mass, calculated as LVMI, of 5 g/m^2 was assumed to be clinically meaningful. Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value.|Baseline and Month 12 (If Month 12 data were not available, the Last Observation Carried Forward [LOCF] analysis, which includes data collected on or after Month 9 of treatment to Month 12 of treatment, was used)|All randomized participants who had a valid MRI at Baseline and Month 12 (LOCF on or after Month 9 to Month 12)||grams per meters squared (g/m^2)||Standard Error|Mean
705546|NCT00108160|Other Pre-specified|S. Aureus Re-infections (New or Recurrent)|The anatomic site of each S. infection at enrollment and S. aureus re-infection that occurred during the study was compared. S. aureus isolated from a different site of infection than at baseline was considered to represent a new infection. Isolation of S. aureus from the same site as the baseline infection was considered to represent a recurrent infection.|18 months|||participants|||Number
705547|NCT00108160|Secondary|Acquisition of New S. Aureus Strains|In the Mupirocin Ointment (Treatment) and Polyethylene Glycol (Placebo) Arms, S. aureus isolates (MSSA or MRSA) that caused infection prior to enrollment in the study were compared with S. aureus infecting isolates (MSSA or MRSA) that occurred during the study (re-infections). Infecting isolates that were found to be MRSA at enrollment and MRSA during the study were considered to be the same strain; this same strain definition was also applied to MSSA isolates. Infecting isolates that changed from MRSA at enrollment to MSSA during the study (or vice versa) were considered to be different strains.|18 months|Participants with S. aureus re-infection who acquired a new strain during the 18 month study period.||participants|||Number
705548|NCT00108160|Primary|Re-infection With S. Aureus|During the study, patients with prior well-documented infections with Staphylococcus aureus who developed new signs and symptoms of infection, met standardized clinical criteria for infection, and had S. aureus isolated on culture were considered to have re-infection with S. aureus. The number of S. aureus re-infections were compared in the mupirocin ointment (Treatment Arm) versus polyethylene glycol ointment (Placebo Arm) for all participants enrolled in the study and in participants who completed each study time point (visit)|18 months|Re-infections with S. aureus, new or recurrent, were noted for all patients enrolled in the study and for patients who completed each study visit.||participants with S. aureus re-infection|||Number
705549|NCT00108277|Primary|Episodic Anxiety Scale|Episodic Anxiety Scale (EAS) is a modification of the Panic Disorder Severity Scale (Shear et al., 1997) that includes 2 additional questions regarding acute anxiety episodes that may not meet full criteria for a panic attack. The EAS consists of 9 questions, each ranging from 0 (none) to 4 (worst possible). The EAS total score is the sum of all 9 items, such that the minimum total score = 0 (no anxiety symptoms) and maximum total score = 36 (worst possible anxiety symptoms).|1 month|||units on a scale||Standard Deviation|Mean
705550|NCT00108303|Primary|Log of the ODDS of Linkage|Log of the ODDS ratio of Linkage divided by the ODDS of no linkage from a maximum likelihood analysis conducted using the statistical program LINKAGE|1 day|Probands with schizophrenia, their relatives, and controls. The log of the odds ratio summarizes data from the entire study population.||units on a log scale|||Number
705551|NCT00108303|Primary|Heritability Coefficient|h squared which ranges from 0 to 1. This number is similar to the more standard Pearson's correlation coefficient, except that the variable, in this case P50 sensory gating, is correlated across the statuses: schizophrenia proband (has the illness), schizophrenia relative (not ill but relative of someone who is), or control (not ill and has no known ill relative, P50 is a Positive wave in scalp-recorded auditory evoked potential that occurs 50 msec after the sound stimulus. P50 sensory gating is the decrement in this wave to the second of repeated sounds.|5 years|Schizophrenia probands and relatives and controls.||coefficient|Participants||Number
705552|NCT00108303|Primary|Genetic Linkage|Log of the Odds for Linkage, a standard genetic analysis metric. The number shown as a result is from a polymorphism in the promoter of the gene for the alpha7 nicotinic receptor on chromosome. Its presence in the individuals in this study, considering all three groups in one analysis, is compared to what of P50 sensory gating. P50 is a Positive wave in scalp-recorded auditory evoked potential that occurs 50 msec after the sound stimulus. P50 sensory gating is the decrement in this wave to the second of repeated sounds. The log of the odds is the common logarithm of the ratio of the odds that the gene polymorphism and P50 sensory gating are associated versus the odds that they are both distributed in the individuals at random. It is similar to the more common chi squared.|ten years|People with schizophrenia and their relatives in families and controls as members of single families were used to establish the log of the odds ratio.||log (odds ratio)|||Number
705553|NCT00108342|Primary|Quit Attempts, Use of NRTs, Preference Among NRTs|In addition to quit attempts, use of NRTs, and preference among NRTs, we also planned to assess learning and changes in motivation at all visits. Unfortunately, the study was terminated due to common comorbidities among the Veterans that precluded entry into the study. Due to the consequent small sample size, we did not analyze any data.|At testing, at follow-up|The study was terminated and the data were not analyzed due to the small sample size.|||||
705554|NCT00108355|Secondary|Development of Post-paracentesis Circulatory Dysfunction (PCD)|Defined as an increase in Plasma Renin Activity (PRA) by >50% from baseline to a level > 4 ng/mL/h at post-paracentesis day|6 days after paracentesis|Plasma Renin Activity (lab value to measure PCD) was not available for 6 patients leaving 11 patients in Albumin (control group) and 8 patients in Vasoconstrictor (Treatment group) for this outcome analysis.||participants|||Number
705555|NCT00108355|Primary|Time to Recurrence of Ascites.|Comparison between Albumin (Control group) and Vasoconstrictor (Treatment group)|Variable depending on the patient, average 10 days|||days||Inter-Quartile Range|Median
705556|NCT00108433|Secondary|Percentage of Participants With Eradication of Staphylococcus Aureus Nasal Colonization|Eradication was defined as the absence of the original baseline nasal Staphylococcus aureus isolated in nasal swab culture.|STFU visit for TOC (2 to 3 weeks after the last dose of study medication), LTFU visit (6 to 8 weeks after the last dose of study medication)|Data was not analyzed because there were not enough participants to perform a meaningful efficacy analysis due to early termination of the study.||Percentage of participants|||Number
705557|NCT00108433|Secondary|Percentage of Pathogens Eradicated|Eradication included Documented or Presumed Eradication of the given pathogen. Percentage of pathogen eradicated was calculated as number of pathogens eradicated divided by number of pathogens eradicated or persisted multiplied by 100.|STFU visit for TOC (2 to 3 weeks after the last dose of study medication), LTFU visit (6 to 8 weeks after the last dose of study medication)|Data was not analyzed because there were not enough participants to perform a meaningful efficacy analysis due to early termination of the study.||Percentage of Pathogens|||Number
705558|NCT00108433|Secondary|Number of Participants With Complications During Therapy|Late metastatic sequelae associated with Gram positive bacterial infections: abdominal abscess, brain abscess, meningitis, septic arthritis, osteomyelitis, endocarditis, empyema, spinal epidural abscess, intracerebral epidural abscess, septic phlebitis and septic thrombophlebitis.|LTFU visit (6 to 8 weeks after the last dose of study medication)|Data was not analyzed because there were not enough participants to perform a meaningful efficacy analysis due to early termination of the study.||participants|||Number
705559|NCT00108433|Secondary|Number of Participants With Clinical Outcome Based on Sponsor's (Sp) and Investigator's (Ir) Assessment|Ir assessment Cure: clinical signs/symptoms of infection (SSx) resolved and no reoccurrence; Improvement: Moderate resolution of SSx, no additional antibiotic needed; Failure: persistence/progression of baseline SSx, new clinical findings; Indeterminate: circumstances precluding above classification. Sp assessment Failure: concomitant antibiotic after day 3 up to/including Ir assessment day at TOC/upper limit of TOC window (if no Ir assessment at TOC), no Ir assessment at end of treatment (EOT) and TOC; Indeterminate: Sp assessment cured/ improved at EOT, no Ir assessment at TOC/indeterminate.|EOT (within 72 hours after last dose of study medication), STFU visit for TOC (2 to 3 weeks after the last dose of study medication), Long term follow-up (LTFU) visit (6 to 8 weeks after the last dose of study medication)|Data was not analyzed because there were not enough participants to perform a meaningful efficacy analysis due to early termination of the study.||participants|||Number
705560|NCT00108433|Primary|Number of Participants With Microbiological Response at Test-of-Cure (TOC) Visit|Microbiological response assessed at participant level. Eradication = baseline isolate not present in repeat culture from the original infection site; Presumed Eradication = clinical response of cure based on Sponsor's (Sp) assessment, culture data not available for participants; Persistence = baseline isolate present in repeat culture from the original infection site; Presumed Persistence = culture data not available for participants with a clinical response of failure based on Sp assessment.|Short term follow-up (STFU) visit for TOC (2 to 3 weeks after the last dose of study medication)|Data was not analyzed because there were not enough participants to perform a meaningful efficacy analysis due to early termination of the study.||participants|||Number
705561|NCT00110890|Secondary|Number of Participants With Mean Serum P < 5.5 mg/dL|Number of participants with mean serum phosphorus (P) < 5.5 mg/dL during the efficacy assessment phase|Efficacy Assessment Phase (weeks 17 to 23)|Full Analysis Set, composed of all randomized participants with imputation using modified last value carried forward (mLVCF)||Participants|||Number
705562|NCT00110890|Secondary|Number of Participants With Mean Serum Ca < 9.5 mg/dL|Number of participants with mean serum calcium (Ca) < 9.5 mg/dL during the efficacy assessment phase|Efficacy Assessment Phase (weeks 17-23)|Full Analysis Set, composed of all randomized participants with imputation using modified last value carried forward (mLVCF)||Participants|||Number
710933|NCT00168844|Secondary|Change From Baseline in Lymphocytes (Absolute)|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||10^9/L||Standard Deviation|Mean
705566|NCT00110994|Secondary|Change of European Quality of Life Visual Analogue Scale (EQ-VAS) Score From Baseline to the End of Treatment|European Quality of Life Visual Analogue Scale (EQ-VAS) is a self-administered test that records the respondents’ self-rated health status on a visual analogue scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). Responders specify their scales by indicating a position along a continuous line between 0 and 100.|Baseline and every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days|Change of EQ-VAS score was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment.||scores on a scale||Standard Deviation|Mean
705567|NCT00110994|Secondary|Change of European Quality of Life Visual Analogue Scale (EQ-VAS) Score From Baseline to the Visit at Which Best Response Was First Noted|European Quality of Life Visual Analogue Scale (EQ-VAS) is a self-administered test that records the respondents' self-rated health status on a visual analogue scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). Responders specify their scales by indicating a position along a continuous line between 0 and 100.|Baseline and every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days|Change of EQ-VAS score was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment.||scores on a scale||Standard Deviation|Mean
705568|NCT00110994|Secondary|Change of European Quality of Life 5-dimensional (EQ-5D) Questionnaire Index Score From Baseline to the End of Treatment|European Quality of Life 5-dimensional (EQ-5D) is a self-administered questionnaire developed to measure health status across 5 dimensions: Mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has 3 levels of response: No problem (1), some problems (2), and extreme problems (3). The five dimensions are summarized into a single score, the EQ‑5D index score, which ranges between 0 and 1, with 0 representing the worst imaginable health state or death and 1 representing perfect health.|Baseline and every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days|Change of EQ-5D questionnaire index score was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment.||scores on a scale||Standard Deviation|Mean
705569|NCT00110994|Secondary|Change of European Quality of Life 5-dimensional (EQ-5D) Questionnaire Index Score From Baseline to the Visit at Which Best Response Was First Noted|European Quality of Life 5-dimensional (EQ-5D) is a self-administered questionnaire developed to measure health status across 5 dimensions: Mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has 3 levels of response: No problem (1), some problems (2), and extreme problems (3). The five dimensions are summarized into a single score, the EQ‑5D index score, which ranges between 0 and 1, with 0 representing the worst imaginable health state or death and 1 representing perfect health.|Baseline and every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days|Change of EQ-5D questionnaire index score was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment.||scores on a scale||Standard Deviation|Mean
705570|NCT00110994|Secondary|Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to the Visit When the Best Tumor Response Was Noted|Change in ECOG PS is defined as an improvement (increase) or worsening (decrease) of at least one grade from the baseline ECOG score (from 0 [fully active] to 5 [dead]). Change in ECOG PS was recorded at the visit at which best confirmed response (BCR) using the modified RECIST (PR, CR, stable disease or Progressive Disease (PD)) was first noted (the change was 7% for both Sorafenib and Placebo). The BCR is the BCR recorded from the start of the treatment until DP/recurrence (taking as reference for DP, the smallest measurements recorded since treatment started).|Baseline and every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days|Change in ECOG performance status was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment.||participants|||Number
705571|NCT00110994|Secondary|Duration of Response (DOR)|Duration of response was defined as the time from the first documented objective response of Partial Response (PR: At least a 30% decrease in the sum of the longest diameter [SLD] of target lesions, taking as reference the baseline SLD or better) or Complete Response (CR: Disappearance of all target lesions), whichever was noted earlier, to disease progression or death (if death occurred before progression was documented). Duration of response for subjects who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment.|Time from initial response to documented tumor progression or death (median time of 188 days)|DOR was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment.||days||95% Confidence Interval|Median
705572|NCT00110994|Secondary|Time to Progression (TTP)|TTP was calculated as the time (days) from date of randomization to date of first observed disease progression (per modified RECIST or clinical judgment, whichever was earlier: CR, PR, stable disease, progressive disease). The actual dates of tumor assessments were used for this calculation. TTP for subjects without disease progression at the time of analysis, including subjects with death prior to progression, was censored at the last date of tumor evaluation. TTP for subjects who had no tumor assessments after baseline was censored at 1 day.|Time from randomization to documented tumor progression (median time of 148 days)|TTP was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment.||days||95% Confidence Interval|Median
705573|NCT00110994|Secondary|Number of Participants in Tumor Response Categories|Tumor response was defined as the best response (confirmed complete response [CR], partial response [PR], stable disease [SD], or progressive disease [PD]) assessed using the Response Evaluation Criteria in Solid Tumors (RECIST). PR: At least a 30% decrease in the sum of the longest diameter [SLD] of target lesions, taking as reference the baseline SLD. CR: Disappearance of all target lesions. SD: Does not qualify for CR or PR. PD: at least a 20% increase in SLD taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions.|Every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days|Tumor response was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment.||participants|||Number
705574|NCT00110994|Secondary|Overall Survival (OS)|Overall Survival (OS) was calculated as the number of days from date of randomization to death date. Subjects who had not died at the time of analysis were censored at their last contact date.|Time from randomization to death (the maximum treatment duration of 71.1 weeks)|OS was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment.||days||95% Confidence Interval|Median
705575|NCT00110994|Primary|Progression Free Survival (PFS)|PFS was calculated as the time (days) from date of randomization to date of first observed DP (per modified Response Evaluation Criteria In Solid Tumors [RECIST] or clinical judgment, whichever was earlier: CR, PR, stable disease, progressive disease) or death due to any cause, if death occurred before progression was documented. The actual date of tumor assessments was used for this calculation. PFS for subjects without progression or death was censored at the last date of tumor evaluation. PFS for subjects who had no tumor assessments after baseline and did not die was censored at 1 day.|Time from randomization to documented tumor progression or death (the maximum treatment duration of 71.1 weeks)|PFS was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment.||days||95% Confidence Interval|Median
705576|NCT00111007|Secondary|Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status to the Visit When the Best Tumor Response Was Noted|Change in ECOG PS is defined as an improvement (increase) or worsening (decrease) of at least one grade from the baseline ECOG score (from 0 [fully active] to 5 [dead]). Change in ECOG PS was recorded at the visit at which best confirmed response (BCR) using the modified RECIST (PR, CR, stable disease or Progressive Disease (PD)) was first noted (the change was 7% for both Sorafenib and Placebo). The BCR is the BCR recorded from the start of the treatment until DP/recurrence (taking as reference for DP, the smallest measurements recorded since treatment started).|baseline and at visit when best response was noted (maximum treatment duration of 68.3 weeks)|Change in ECOG PS was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment. For the ITT population, subjects were included in the treatment group assigned at randomization, regardless of the treatment received.||participants|||Number
705577|NCT00111007|Secondary|Duration of Response (DOR)|Duration of response was defined as the time from the first documented objective response of Partial Response (PR: At least a 30% decrease in the sum of the longest diameter [SLD] of target lesions, taking as reference the baseline SLD or better) or Complete Response (CR: Disappearance of all target lesions), whichever was noted earlier, to disease progression or death (if death occurred before progression was documented). Duration of response for subjects who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment.|Time from initial response to documented tumor progression or death (median time of 197 days)|DOR was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment. For the ITT population, subjects were included in the treatment group assigned at randomization, regardless of the treatment received.||days||Full Range|Median
705578|NCT00111007|Secondary|Time to Progression (TTP)|TTP was calculated as the time (days) from date of randomization to date of first observed disease progression (DP) (per modified RECIST or clinical judgment, whichever was earlier: CR, PR, stable disease, progressive disease). The actual dates of tumor assessments were used for this calculation. TTP for subjects without disease progression at the time of analysis, including subjects with death prior to progression, was censored at the last date of tumor evaluation. TTP for subjects who had no tumor assessments after baseline was censored at 1 day.|Time from randomization to documented tumor progression (median time of 126 days)|TTP was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment. For the ITT population, subjects were included in the treatment group assigned at randomization, regardless of the treatment received.||days||95% Confidence Interval|Median
705579|NCT00111007|Secondary|Overall Survival (OS)|Overall survival (OS) was calculated as the number of days from date of randomization to death date. Subjects who had not died at the time of analysis were censored at their last contact date.|Time from randomization to death (median time of 294 days)|OS was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment. For the ITT population, subjects were included in the treatment group assigned at randomization, regardless of the treatment received.||days||95% Confidence Interval|Median
705580|NCT00111007|Primary|Progression Free Survival (PFS)|PFS was calculated as the time (days) from date of randomization to date of first observed DP (per modified Response Evaluation Criteria In Solid Tumors [RECIST] or clinical judgment, whichever was earlier: CR, PR, stable disease, progressive disease) or death due to any cause, if death occurred before progression was documented. The actual date of tumor assessments was used for this calculation. PFS for subjects without progression or death was censored at the last date of tumor evaluation. PFS for subjects who had no tumor assessments after baseline and did not die was censored at 1 day.|Time from randomization to documented tumor progression or death (median time of 124 days)|PFS was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment. For the ITT population, subjects were included in the treatment group assigned at randomization, regardless of the treatment received.||days||95% Confidence Interval|Median
705581|NCT00111657|Secondary|Infusion 1: Minimum Concentration (Cmin)|The lowest drug concentration in the blood after the first infusion of study drug.|21 days after the infusion|One subject withdrew prior to completing the first infusion and is not included in this analysis.||mU/mL||Standard Deviation|Mean
705582|NCT00111657|Secondary|Infusion 1: Maximum Concentration (Cmax) Value|The highest drug concentration in the blood after the first infusion of study drug.|2 hours|One subject withdrew prior to completing the first infusion and is not included in this analysis.||mU/mL||Standard Deviation|Mean
705583|NCT00111657|Secondary|Development of Antibodies to PEG-uricase|Number of patients who developed antibodies to PEG-uricase|baseline, then prior to infusions and 7 wks after last infusion|One subject withdrew prior to completing the first infusion and is not included in this analysis.||participants|||Number
705584|NCT00111657|Secondary|Reduction of the Ratio of Uric Acid:Creatinine in Urine||baseline then weekly|These data were not calculated because the effect size of serum irate reduction in plasma was so robust that there was no utility in this assessment.|||||
705585|NCT00111657|Secondary|In a Subset of Subjects Who Volunteer Separately, Change in Uric Acid Pool Size Will be Assessed by a Method That Involves Infusion of Uric Acid Labeled With N15, a Stable (Nonradioactive) Isotope of Nitrogen.||baseline and 7 weeks after last infusion|Data was not collected for this outcome as a result of a separate pilot study demonstrating that the measure was not useful.|||||
705586|NCT00111657|Secondary|Clinical Response: Number of Swollen and Tender Joints|Count of tenderness and swelling of 68 joints|Basline and day 134|30 subject assesed at baseline. 21 subjects who completed study were assesed at day 134||joints||Inter-Quartile Range|Median
705587|NCT00111657|Primary|Reduction in Plasma Uric Acid to Less Than 6 mg/dL.||Baseline to Day 105|||Participants|||Number
705588|NCT00111761|Secondary|Time to Initial Objective Tumor Response (Part 1)|Median time to first observed objective tumor response (complete or partial) among responders in Part 1 of the study.|Until disease progression (median 35 weeks) or 48 weeks, whichever occurred first|Subset of Subjects Treated Analysis Set, composed of all consented participants who received at least 1 dose of panitumumab and at least 1 dose of chemotherapy, who had an objective tumor response.||weeks||Inter-Quartile Range|Median
705589|NCT00111761|Secondary|Time to Treatment Failure (Part 1)|Kaplan-Meier estimate of the median time from the date of first dose of panitumumab or chemotherapy to the date the decision was made to end treatment for any reason in Part 1 of the study.|Until disease progression (median 35 weeks) or 48 weeks, whichever occurred first|Subjects Treated Analysis Set, composed of all consented participants who received at least 1 dose of panitumumab and at least 1 dose of chemotherapy.||Weeks||95% Confidence Interval|Median
705590|NCT00111761|Secondary|Survival Time (Part 1)|Kaplan-Meier estimate of the median time from enrollment to death from any cause. Participants who did not die on study were censored at their last contact date.|From enrollment until death. Maximum follow-up time was 25 months.|Subjects Treated Analysis Set, composed of all consented participants who received at least 1 dose of panitumumab and at least 1 dose of chemotherapy.||weeks||95% Confidence Interval|Median
705591|NCT00111761|Secondary|Time to Disease Progression (Part 1)|Kaplan-Meier estimate of the median time from the first dose of study drug to disease progression or death if due to disease progression (whichever comes first) in Part 1 of the study. Participants who had not progressed or died for reasons other than disease progression were censored at their last disease assessment date.|From enrollment until disease progression or death. Maximum follow-up time was 25 months.|Subjects Treated Analysis Set, composed of all consented participants who received at least 1 dose of panitumumab and at least 1 dose of chemotherapy.||weeks||95% Confidence Interval|Median
705592|NCT00111761|Secondary|Progression-free Survival Time (Part 1)|Kaplan-Meier estimate of median time from enrollment to death or disease progression in Part 1 of the study. Participants who had not progressed and had not died were censored at their last disease assessment date.|From enrollment until disease progression or death. Maximum follow-up time was 25 months.|Subjects Treated Analysis Set, composed of all consented participants who received at least 1 dose of panitumumab and at least 1 dose of chemotherapy.||weeks||95% Confidence Interval|Median
705593|NCT00111761|Secondary|Number of Participants With Objective Tumor Response (Part 1)|Objective tumor response (complete or partial) in Part 1 of the study, based on Response Evaluation Criteria in Solid Tumors (RECIST), where complete response = disappearance of all target lesions, partial response = ≥30% reduction in lesion size, progressive disease = ≥20% increase in tumor size; otherwise stable disease.|Until disease progression (median 35 weeks) or 48 weeks, whichever occurred first|Subjects Treated Analysis Set, composed of all consented participants who received at least 1 dose of panitumumab and at least 1 dose of chemotherapy.||Participants|||Number
705594|NCT00111761|Secondary|Number of Participants Who Died (Part 2)|The number of participants in Part 2 who died during the study.|From enrollment until last contact. Maximum follow-up was 16 months.|Subjects Treated Analysis Set, composed of participants who received at least one dose of panitumumab or one dose of chemotherapy||participants|||Number
705595|NCT00111761|Secondary|Survival Time (Part 2)|Kaplan-Meier estimate of the median time from enrollment to death from any cause. Participants who did not die on study were censored at their last contact date.|From enrollment until death. Maximum follow-up time was 16 months.|Subjects Treated Analysis Set, composed of all consented participants who received at least 1 dose of panitumumab and at least 1 dose of chemotherapy.||weeks||95% Confidence Interval|Median
705596|NCT00111761|Secondary|Progression-free Survival Time (Part 2)|Kaplan-Meier estimate of median time from enrollment to death or disease progression in Part 2 of the study. Participants who had not progressed and had not died were censored at their last disease assessment date.|From enrollment until disease progression or death. Maximum follow-up time was 16 months.|Subjects Treated Analysis Set, composed of participants who received at least one dose of panitumumab or one dose of chemotherapy||weeks||95% Confidence Interval|Median
705597|NCT00111761|Secondary|Time to Disease Progression (Part 2)|Kaplan-Meier estimate of median time from the first dose of study drug to first observed disease progression or death if the death was due to disease progression (whichever comes first) in Part 2 of the study. Participants who had not progressed or died for reasons other than disease progression were censored at their last disease assessment date.|From enrollment until death or diease progression. Maximum follow-up time was 16 months.|Subjects Treated Analysis Set, composed of participants who received at least one dose of panitumumab or one dose of chemotherapy||weeks||95% Confidence Interval|Median
705598|NCT00111761|Secondary|Number of Participants With an Objective Tumor Response (Part 2)|Objective tumor response (complete or partial) in Part 2 of the study, based on Response Evaluation Criteria in Solid Tumors (RECIST), where complete response = disappearance of all target lesions, partial response = ≥30% reduction in lesion size, progressive disease = ≥20% increase in tumor size; otherwise stable disease.|Until disease progression (median 47 weeks)|Subjects Treated Analysis Set, composed of participants who received at least one dose of panitumumab or one dose of chemotherapy||Participants|||Number
705599|NCT00111761|Primary|Number of Participants With Grade 3 or Grade 4 Diarrhea (Part 1)|The number of participants with grade 3 or grade 4 diarrhea in Part 1 of the study. Grading of diarrhea followed the grading scale in Version 2.0 of the National Cancer Institute Common Toxicity Criteria (NCI CTC).|Until disease progression (median 35 weeks) or 48 weeks, whichever occurred first|Subjects Treated Analysis Set, composed of all consented participants who received at least 1 dose of panitumumab and at least 1 dose of chemotherapy.||Participants|||Number
705600|NCT00111761|Primary|Number of Participants With Grade 3 or Grade 4 Diarrhea (Part 2)|The number of participants with grade 3 or grade 4 diarrhea in Part 2 of the study. Grading of diarrhea followed the grading scale in Version 2.0 of the National Cancer Institute Common Toxicity Criteria (NCI CTC).|Until disease progression (median 47 weeks)|Subjects Treated Analysis Set, composed of participants who received at least one dose of panitumumab or one dose of chemotherapy.||Participants|||Number
705675|NCT00112112|Secondary|T- and B-lymphocyte Subsets by Flow Cytometry - Absolute Neutrophils|Mean and standard deviation results of absolute neutrophils subsets is reported.|pre-dosing (Day 0)|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.||Cells per 10^3/UL||Standard Deviation|Mean
705601|NCT00111813|Secondary|Laboratory AE Summary|"An AE was defined as any unfavorable/unintended change in the structure/function/chemistry of the body temporally associated with the use of study drug, or any worsening of a preexisting condition.
A SAE was any AE that resulted in death, was life threatening, resulted in a persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a new cancer, or was an overdose.
A lab (S)AE was any lab value considered clinically significant in the investigator's judgment."|Day 1 up to disease progression, toxicity, or death, assessed up to 29 months|||Participants|||Number
705602|NCT00111813|Secondary|Clinical AE Summary|"An AE was defined as any unfavorable/unintended change in the structure/function/chemistry of the body temporally associated with the use of study drug, or any worsening of a preexisting condition.
A serious AE (SAE) was any AE that resulted in death, was life threatening, resulted in a persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a new cancer, or was an overdose."|Day 1 up to disease progression, toxicity, or death, assessed up to 30 days after end of treatment (up to 30 months)|||Participants|||Number
705603|NCT00111813|Secondary|Mean Time to First AE Resulting in a Dose Modification in Either Vorinostat or Bortezomib|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the sponsor's product, was also an adverse experience.|Day 1 to disease progression, toxicity, or death, assessed up to 29 months|||Days||Standard Deviation|Mean
705604|NCT00111813|Secondary|Number of Participants With Dose Modifications of Either Vorinostat or Bortezomib Due to Adverse Experiences (AEs) After Treatment With Study Drug|An adverse experience (AE) was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the sponsor's product, was also an adverse experience.|Day 1 to disease progression, toxicity, or death, assessed up to 29 months|||Participants|||Number
705605|NCT00111813|Primary|Mean Duration of Treatment With Vorinostat|"Event causing discontinuation from the study was defined as (1) progressive disease OR (2) intolerable toxicity.
Progressive disease was defined as:
>25% increase in the level of serum monoclonal paraprotein.
25% increase in 24-hour urinary light chain excretion.
>25% increase in plasma cells in a bone marrow aspirate or on trephine
biopsy.
Development of new bone lesions or soft tissue plasmacytomas.
Development of hypercalcemia.
Intolerable toxicity was based on the clinical judgment of the investigator."|Day 1 to an event causing discontinuation from the study, assessed up to 29 months|||Days||Full Range|Mean
705606|NCT00111917|Post-Hoc|BAL % Lymphocytes|% of WBCs that are lymphocytes in bronchoalveolar lavage|after 28 week infusion|||percentage of lymphocytes in BAL||Standard Deviation|Median
705607|NCT00111917|Post-Hoc|BAL WBC/cc|WBC * 10^6/cc in bronchalveolar lavage|after 28 weeks|||absolute WBC*10^6/cc||Standard Deviation|Median
705608|NCT00111917|Primary|A-a Gradient at End Exercise|change in end-exercise A-a gradient|after 28 week follow-up. The Alveolar-arterial gradient (A-a gradient), is a measure of the difference between the alveolar partial pressure (A) of oxygen and the arterial (a) partial pressure of oxygen|Accurate measures were not obtained on all patients at both timepoints.||mmHg||Standard Error|Median
705609|NCT00111917|Post-Hoc|Absolute Numbers of Lymphocytes|Absolute number of lymphocytes*10^6/cc in blood|after 28 week follow-up|||absolute number*10^6/cc||Standard Error|Median
705610|NCT00112047|Secondary|Quality of Life (SF-12v2 Health Survey: Mental Component Summary) Change From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)|The change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) in the SF-12v2 Health Survey MCS. The SF-12v2 includes 8 concepts commonly represented in health surveys: physical functioning, role functioning physical, bodily pain, general health, vitality, social functioning, role functioning emotional, and mental health. Results are expressed in terms of 2 composite scores: the PCS and the MCS. PCS and MCS values can range from 0 to 100 and are designed to have a mean value of 50 and a SD of 10 (in the general population).|Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)|Atripla Efficacy Analysis Set||Composite Score||Standard Deviation|Mean
705611|NCT00112047|Secondary|Quality of Life (SF-12v2 Health Survey: Physical Component Summary) Change From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)|The change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) in the SF-12v2 Health Survey: Physical Component Summary (PCS). The SF-12v2 includes 8 concepts commonly represented in health surveys: physical functioning, role functioning physical, bodily pain, general health, vitality, social functioning, role functioning emotional, and mental health. Results are expressed in terms of 2 composite scores: the PCS and the Mental Component Summary (MCS). PCS and MCS values can range from 0 to 100 and are designed to have a mean value of 50 and SD of 10 (in the general population).|Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)|Atripla Efficacy Analysis Set||Composite Score||Standard Deviation|Mean
705612|NCT00112047|Secondary|Treatment Satisfaction Questionnaire (Bothered With the Side Effects of Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline.|"Participants were asked: How bothered are you with the side effects of your current treatment regimen? Possible responses were on a 4-category scale: does not bother me; bothers me a little bit; bothers me a lot; and bothers me terribly. For the evaluation of the change in treatment satisfaction from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) responses were dichotomized into does not bother me and bothers me (bothers me included bothers me a little bit; bothers me a lot; bothers me terribly)."|Week 144 ([W 144]; Atripla baseline) to Week 240 ([W 240]; Atripla Week 96)|Atripla Efficacy Analysis Set||Participants|||Number
705676|NCT00112112|Secondary|T- and B-lymphocyte Subsets by Flow Cytometry - Absolute Lymphocytes|Mean and standard deviation results of absolute lymphocytes subsets is reported.|7-10 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.||Cells per 10^3/UL||Standard Deviation|Mean
705613|NCT00112047|Secondary|Treatment Satisfaction Questionnaire (General Satisfaction With Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline.|"Participants were asked: In general, how satisfied are you with your current treatment regimen? Possible responses were on a 4-category scale: very satisfied; somewhat satisfied; somewhat dissatisfied; and very dissatisfied. For the evaluation of changes in treatment satisfaction from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) responses were dichotomized into very satisfied and not very satisfied (not very satisfied included very dissatisfied; somewhat dissatisfied; and somewhat satisfied)."|Week 144 ([W 144]; Atripla baseline) to Week 240 ([W 240]; Atripla Week 96)|Atripla Efficacy Analysis Set||Participants|||Number
705614|NCT00112047|Secondary|Treatment Satisfaction Questionnaire (Satisfaction With Tolerability of Current Treatment Regimen) Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline.|"Participants were asked: In general, how satisfied are you with your ability to tolerate your current treatment regimen? Possible responses were on a 4-category scale: very satisfied; somewhat satisfied; somewhat dissatisfied; and very dissatisfied. For the evaluation of changes in treatment satisfaction from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) responses were dichotomized into very satisfied and not very satisfied (not very satisfied included very dissatisfied; somewhat dissatisfied; and somewhat satisfied)."|Week 144 ([W 144]; Atripla baseline) to Week 240 ([W 240]; Atripla Week 96)|Atripla Efficacy Analysis Set||Participants|||Number
705615|NCT00112047|Secondary|Treatment Satisfaction Questionnaire (Satisfaction With Current Treatment Regimen to Control HIV): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline.|"Participants were asked: In general, how satisfied are you with the ability of your current treatment regimen to control your HIV infection? Possible responses were on a 4-category scale: very satisfied; somewhat satisfied; somewhat dissatisfied; and very dissatisfied. For the evaluation of changes in treatment satisfaction from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) responses were dichotomized into very satisfied and not very satisfied (not very satisfied included very dissatisfied; somewhat dissatisfied; and somewhat satisfied)."|Week 144 ([W 144]; Atripla baseline) to Week 240 ([W 240]; Atripla Week 96)|Atripla Efficacy Analysis Set||Participants|||Number
705616|NCT00112047|Secondary|Treatment Satisfaction Questionnaire (Satisfaction With Convenience and Simplicity of Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline.|"Participants were asked: In general, how satisfied are you with the convenience and simplicity of your current treatment regimen? Possible responses were on a 4-category scale: very satisfied; somewhat satisfied; somewhat dissatisfied; and very dissatisfied. For the evaluation of changes in treatment satisfaction from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) responses were dichotomized into very satisfied and not very satisfied (not very satisfied included very dissatisfied; somewhat dissatisfied; and somewhat satisfied)."|Week 144 ([W 144]; Atripla baseline) to Week 240 ([W 240]; Atripla Week 96)|Atripla Efficacy Analysis Set||Participants|||Number
705617|NCT00112047|Secondary|Change in Total Body Fat (kg) From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)|Change from Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) in total body fat = Week 240 (Atripla Week 96) total body fat value minus Week 144 (Atripla Baseline) total body fat value|Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)|Atripla Efficacy Analysis Set||total body fat (kg)||Standard Deviation|Mean
705618|NCT00112047|Secondary|Change in Trunk Fat (kg) From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)|Change from Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) in trunk fat = Week 240 (Atripla Week 96) trunk fat value minus Week 144 (Atripla Baseline) trunk fat value|Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)|Atripla Efficacy Analysis Set||trunk fat (kg)||Standard Deviation|Mean
705619|NCT00112047|Secondary|Change in Limb Fat (kg) From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)|Change from Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) in limb fat = Week 240 (Atripla Week 96) limb fat value minus Week 144 (Atripla Baseline) limb fat value|Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)|Atripla Efficacy Analysis Set||limb fat (kg)||Standard Deviation|Mean
705620|NCT00112047|Secondary|Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 240 (Atripla Week 96)|Change from baseline to Week 240 (Atripla Week 96) in CD4 cell count = Week 240 (Atripla Week 96) CD4 cell count value minus baseline CD4 cell count value|Study/Atripla baseline to Week 240 (Atripla Week 96)|Atripla Efficacy Analysis Set||CD4 Cell count (Cells/mm^3)||Standard Deviation|Mean
705621|NCT00112047|Secondary|Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 50 c/mL) Through Week 240 (Atripla Week 96)|Participants who achieved confirmed HIV-1 RNA < 50 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date.|Week 240 (Atripla Week 96)|"MITT Analysis Set (EFV+FTC+TDF group from study baseline; N=244).
Atripla Efficacy Analysis Set (All Atripla Group from Atripla baseline; N=286)"||Percentage of Participants|||Number
705622|NCT00112047|Secondary|Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 400 c/mL) Through Week 240 (Atripla Week 96)|Participants who achieved confirmed HIV-1 RNA < 400 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date.|Week 240 (Atripla Week 96)|"MITT Analysis Set (EFV+FTC+TDF group from study baseline; N=244).
Atripla Efficacy Analysis Set (All Atripla Group from Atripla baseline; N=286)"||Percentage of Participants|||Number
705623|NCT00112047|Secondary|Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) From Week 144 (Atripla Baseline) Through Week 240 (Atripla Week 96)|TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 50 c/mL or last HIV-1 RNA ≥ 50 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 50 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered “non-responders” on Study Day 1.|Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)|Atripla Efficacy Analysis Set||Percentage of Participants|||Number
705677|NCT00112112|Secondary|T- and B-lymphocyte Subsets by Flow Cytometry - Absolute Lymphocytes|Mean and standard deviation results of absolute lymphocytes subsets is reported.|pre-dosing (Day 0)|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.||Cells per 10^3/UL||Standard Deviation|Mean
705624|NCT00112047|Secondary|Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) From Week 144 (Atripla Baseline) Through Week 240 (Atripla Week 96)|TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 400 c/mL or last HIV-1 RNA ≥ 400 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 400 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered “non-responders” on Study Day 1.|Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)|Atripla Efficacy Analysis Set||Percentage of Participants|||Number
705625|NCT00112047|Secondary|Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Week 240 (Atripla Week 96)|The percentage of participants with plasma HIV-1 RNA < 50 c/mL at Week 240. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 50 c/mL (i.e., ITT missing or switch=failure analysis).|Week 240 (Atripla Week 96)|Atripla Efficacy Analysis Set||Percentage of Participants|||Number
705626|NCT00112047|Secondary|Percentage of Participants With Plasma HIV-1 RNA < 400 c/mL at Week 240 (Atripla Week 96)|The percentage of participants with plasma HIV-1 RNA < 400 c/mL at Week 240. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 400 c/mL (i.e., ITT missing or switch=failure analysis).|Week 240 (Atripla Week 96)|Atripla Efficacy Analysis Set||Percentage of Participants|||Number
705627|NCT00112047|Secondary|Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 240 (Atripla Week 96) Defined by the FDA TLOVR Algorithm|Participants who achieved/maintained confirmed HIV-1 RNA < 50 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 240 visit; 2) achieved confirmed HIV-1 RNA < 50 c/mL on 2 consecutive visits prior to Week 240 visit (that is, the first of the 2 consecutive HIV-1 RNA < 50 c/mL occurred prior to the Week 240 visit; 3) not had confirmed HIV-1 RNA > 50 c/mL after achievement of confirmed HIV RNA levels < 50 c/mL prior to Week 240 visit.|Week 144 (Atripla baseline) to Week 240 (Atripla Week 96)|Atripla Efficacy Analysis Set||Percentage of Participants|||Number
705628|NCT00112047|Secondary|Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 240 (Atripla Week 96) Defined by the FDA TLOVR Algorithm|Participants who achieved/maintained confirmed HIV-1 RNA < 400 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 240 visit; 2) achieved confirmed HIV-1 RNA < 400 c/mL on 2 consecutive visits prior to Week 240 visit (that is, the first of the 2 consecutive HIV-1 RNA < 400 c/mL occurred prior to the Week 240 visit; 3) not had confirmed HIV-1 RNA > 400 c/mL after achievement of confirmed HIV RNA levels < 400 c/mL prior to Week 240 visit.|Week 144 (Atripla baseline) to Week 240 (Atripla Week 96)|Atripla Efficacy Analysis Set (all participants who received at least one dose of Atripla). Data collected after permanent discontinuation of the study regimen was excluded from this analysis set.||Percentage of Participants|||Number
705629|NCT00112047|Secondary|Change in Total Body Fat (kg) From Week 48 to Week 144|Change from Week 48 to Week 144 in total body fat = Week 144 total body fat value minus Week 48 total body fat value|Week 48 to Week 144|ITT (whole body DEXA scans to determine total body fat content were conducted only at selected sites at Week 48, Week 96 and Week 144. ITT analysis set: 86)||total body fat (kg)||Standard Deviation|Mean
705630|NCT00112047|Secondary|Change in Trunk Fat (kg) From Week 48 to Week 144|Change from Week 48 to Week 144 in trunk fat = Week 144 trunk fat value minus Week 48 trunk fat value|Week 48 to Week 144|ITT (whole body DEXA scans to determine trunk fat content were conducted only at selected sites at Week 48, Week 96 and Week 144. ITT analysis set: 86)||trunk fat (kg)||Standard Deviation|Mean
705631|NCT00112047|Secondary|Change in Limb Fat (kg) From Week 48 to Week 144|Change from Week 48 to Week 144 in limb fat = Week 144 limb fat value minus Week 48 limb fat value|Week 48 to Week 144|ITT (whole body DEXA scans to determine limb fat content were conducted only at selected sites at Week 48, Week 96 and Week 144. ITT analysis set: 86)||limb fat (kg)||Standard Deviation|Mean
705632|NCT00112047|Secondary|Change From Study Baseline in CD4 Cell Count (Cells/mm^3) at Week 144|Change from study baseline to Week 144 in CD4 cell count = Week 144 CD4 cell count value minus study baseline CD4 cell count value|Baseline to Week 144|AT analysis set||CD4 Cell Count (cells/mm^3)||Standard Deviation|Mean
705633|NCT00112047|Secondary|Change From Study Baseline in HIV-1 RNA (Log10 c/mL) at Week 144|Change from study baseline to Week 144 in HIV-1 RNA in log10 scale (Week 144 HIV-1 RNA value in log10 scale minus study baseline HIV-1 RNA value in log10 scale).|Study baseline to Week 144|AT analysis set||Log10 c/mL||Standard Deviation|Mean
705634|NCT00112047|Secondary|Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 50 c/mL) at Week 144|Participants who achieved confirmed HIV-1 RNA < 50 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date.|Week 144|MITT||Percentage of Participants|||Number
705635|NCT00112047|Secondary|Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 400 c/mL) at Week 144|Participants who achieved confirmed HIV-1 RNA < 400 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date.|Week 144|MITT||Percentage of participants|||Number
705636|NCT00112047|Secondary|Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) at Week 144|TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 50 c/mL or last HIV-1 RNA ≥ 50 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 50 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered “non-responders” on Study Day 1.|Week 144|MITT||Percentage of Participants|||Number
705678|NCT00112112|Secondary|T- and B-lymphocyte Subsets by Flow Cytometry - Lymphocytes|Mean and standard deviation results of lymphocytes subsets is reported.|7-10 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.||Percentage of lymphocytes||Standard Deviation|Mean
710934|NCT00168844|Secondary|Change From Baseline in Neutrophils (Absolute)|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||10^9/L||Standard Deviation|Mean
705637|NCT00112047|Secondary|Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) at Week 144|TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 400 c/mL or last HIV-1 RNA ≥ 400 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 400 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered “non-responders” on Study Day 1.|Week 144|MITT||Percentage of Participants|||Number
705638|NCT00112047|Secondary|Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Week 144|The percentage of participants with plasma HIV-1 RNA < 50 c/mL at Week 144. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 50 c/mL (i.e., ITT missing or switch=failure analysis).|Week 144|ITT Analysis set (Missing Observation or Switch in ART=Failure)||Percentage of Participants|||Number
705639|NCT00112047|Secondary|Percentage of Participants With Plasma HIV-1 RNA < 400 c/mL at Week 144|The percentage of participants with plasma HIV-1 RNA < 400 c/mL at Week 144. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 400 c/mL (i.e., ITT missing or switch=failure analysis).|Week 144|ITT Analysis set||Percentage of Participants|||Number
705640|NCT00112047|Secondary|Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 144 (Defined by FDA TLOVR Algorithm)|Participants who achieved/maintained confirmed HIV-1 RNA < 50 c/mL (c/mL) had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug, except nevirapine in place of EFV, prior to Week 144 visit; 2) achieved confirmed HIV-1 RNA < 50 c/mL on 2 consecutive visits prior to Week 144 visit (that is, the first of the 2 consecutive HIV-1 RNA < 50 c/mL occurred prior to the Week 144 visit; 3) not had confirmed HIV-1 RNA > 50 c/mL after achievement of confirmed HIV-1 RNA levels < 50 c/mL prior to Week 144 visit.|Week 144|Week 144 Efficacy Analysis set (excludes the Week 96 responders who did not consent after Week 96 visits from Week 96 efficacy analysis set [Week 144 efficacy analysis set: 458).||Percentage of participants|||Number
705641|NCT00112047|Secondary|Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 144 (Defined by FDA TLOVR Algorithm)|Participants who achieved/maintained confirmed HIV-1 RNA < 400 c/mL had to satisfy the following: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug, except nevirapine in place of EFV, prior to Week 144 visit; 2) achieved confirmed HIV-1 RNA < 400 c/mL on 2 consecutive visits prior to Week 144 visit (i.e., the first of the 2 consecutive HIV-1 RNA < 400 c/mL occurred prior to the Week 144 visit; 3) not had confirmed HIV-1 RNA > 400 c/mL after achievement of confirmed HIV-1 RNA levels < 400 c/mL prior to Week 144 visit.|144 weeks|Week 144 Efficacy Analysis set (excludes the Week 96 responders who did not consent after Week 96 visits from Week 96 efficacy analysis set [Week 144 efficacy analysis set: 456).||Percentage of Participants|||Number
705642|NCT00112047|Secondary|Change in Total Body Fat (kg) From Week 48 to Week 96|Change from Week 48 to Week 96 in total body fat = Week 96 total body fat value minus Week 48 total body fat value|48 weeks to 96 weeks|ITT (whole body DEXA scans to determine total body fat content were conducted only at selected sites at Week 48 and Week 96. ITT analysis set for limb fat analyses: 93)||total body fat (kg)||Standard Deviation|Mean
705643|NCT00112047|Secondary|Change in Trunk Fat (kg) From Week 48 to Week 96|Change from Week 48 to Week 96 in trunk fat = Week 96 trunk fat value minus Week 48 trunk fat value|Week 48 to Week 96|ITT (whole body DEXA scans to determine trunk fat content were conducted only at selected sites at Week 48 and Week 96. ITT analysis set: 93)||trunk fat (kg)||Standard Deviation|Mean
705644|NCT00112047|Secondary|Change in Limb Fat (kg) From Week 48 to Week 96|Change from Week 48 to Week 96 in limb fat = Week 96 limb fat value minus Week 48 limb fat value.|Week 48 to Week 96|ITT (whole body dual-energy X-ray absorptiometry [DEXA] scans to determine limb fat content were conducted only at selected sites at Week 48 and Week 96. ITT analysis set: 93)||limb fat (kg)||Standard Deviation|Mean
705645|NCT00112047|Secondary|Change From Study Baseline in CD4 Cell Count (Cells/mm^3) at Week 96|Change from study baseline to Week 96 in CD4 cell count = Week 96 CD4 cell count value minus study baseline CD4 cell count value|Baseline to Week 96|AT analysis set included all participants who received at least one dose of study medication and had not committed any major protocol violation.||CD4 Cell Count (cells/mm^3)||Standard Deviation|Mean
705646|NCT00112047|Secondary|Change From Study Baseline in HIV-1 RNA (Log10 c/mL) at Week 96|Change from study baseline to Week 96 in HIV-1 RNA in log10 scale (Week 96 HIV-1 RNA value in log10 scale minus study baseline HIV-1 RNA value in log10 scale).|Study baseline to Week 96|AT analysis set included all participants who received at least one dose of study medication and had not committed any major protocol violation.||Log10 c/mL||Standard Deviation|Mean
705647|NCT00112047|Secondary|Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 50 c/mL) at Week 96|Participants who achieved confirmed HIV-1 RNA < 50 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date.|Week 96|MITT||Percentage of Participants|||Number
705648|NCT00112047|Secondary|Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 400 c/mL) at Week 96|Participants who achieved confirmed HIV-1 RNA < 400 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date.|Week 96|MITT||Percentage of Participants|||Number
705649|NCT00112047|Secondary|Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) at Week 96|TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 50 c/mL or last HIV-1 RNA ≥ 50 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 50 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered “non-responders” on Study Day 1.|Week 96|MITT||Percentage of Participants|||Number
705679|NCT00112112|Secondary|T- and B-lymphocyte Subsets by Flow Cytometry - Lymphocytes|Mean and standard deviation results of lymphocytes subsets is reported.|pre-dosing (Day 0)|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.||Percentage of lymphocytes||Standard Deviation|Mean
705650|NCT00112047|Secondary|Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) at Week 96|TLOVR for participants with confirmed virologic response (2 consecutive HIV-1 RNA < 400 c/mL) prior to study drug discontinuation, was the time to the earliest of premature study regimen discontinuation, or confirmed HIV-1 RNA > 400 c/mL (2 consecutive HIV-1 RNA ≥ 400 c/mL, or the last HIV-1 RNA ≥ 400 c/mL followed by premature study regimen discontinuation due to loss to follow-up). Participants who did not achieve confirmed virologic response before premature study regimen discontinuation or last HIV-1 RNA, were assumed to have lost virologic response on Study Day 1.|Week 96|MITT||Percentage of Participants|||Number
705651|NCT00112047|Secondary|Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 96 (Defined by FDA TLOVR Algorithm)|Participants who achieved/maintained confirmed HIV-1 RNA < 50 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 96 visit; 2) achieved confirmed HIV-1 RNA < 50 c/mL on 2 consecutive visits prior to Week 96 visit (that is, the first of the 2 consecutive HIV-1 RNA < 50 c/mL occurred prior to the Week 96 visit; 3) not had confirmed HIV-1 RNA > 50 c/mL after achievement of confirmed HIV RNA levels < 50 c/mL prior to Week 96 visit.|Week 96|Week 96 efficacy analysis excludes Week 48 responders who did not consent after Week 48 visits from MITT analysis set (Week 96 efficacy analysis set: [465])||Percentage of Participants|||Number
705652|NCT00112047|Secondary|Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 96 (Defined by FDA TLOVR Algorithm)|Participants who achieved/maintained confirmed HIV-1 RNA < 400 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 96 visit; 2) achieved confirmed HIV-1 RNA < 400 c/mL on 2 consecutive visits prior to Week 96 visit (that is, the first of the 2 consecutive HIV-1 RNA < 400 c/mL occurred prior to the Week 96 visit; 3) not had confirmed HIV-1 RNA > 400 c/mL after achievement of confirmed HIV RNA levels < 400 c/mL prior to Week 96 visit.|96 Weeks|Week 96 efficacy analysis set excludes Week 48 responders who did not consent after Week 48 visits from MITT analysis set (Week 96 efficacy analysis set: [463])||Percentage of Participants|||Number
705653|NCT00112047|Secondary|Change From Study Baseline in CD4 Cell Count (Cells/mm^3) at Week 48|Change from study baseline to Week 48 in CD4 cell count = Week 48 CD4 cell count value minus study baseline CD4 cell count value|Study baseline to Week 48|AT analysis set included all participants who received at least one dose of study medication and had not committed any major protocol violation.||CD4 Cell Count (cells/mm^3)||Standard Deviation|Mean
705654|NCT00112047|Secondary|Change From Study Baseline in HIV-1 RNA (Log10 c/mL) at Week 48|Change from study baseline to Week 48 in HIV-1 RNA in log10 scale (Week 48 HIV-1 RNA value in log10 scale minus study baseline HIV-1 RNA value in log10 scale).|Study baseline to Week 48|As treated (AT) analysis set included all participants who received at least one dose of study medication and had not committed any major protocol violation.||Log10 c/mL||Standard Deviation|Mean
705655|NCT00112047|Secondary|Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 50 c/mL) at Week 48|Participants who achieved confirmed HIV-1 RNA < 50 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date.|Baseline to 48 Weeks|ITT analysis set||Percentage of participants|||Number
705656|NCT00112047|Secondary|Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 400 c/mL) at Week 48|Participants who achieved confirmed HIV-1 RNA < 400 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date.|Baseline to 48 Weeks|ITT analysis set||Percentage of Participants|||Number
705657|NCT00112047|Secondary|Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) at Week 48|TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 50 c/mL or last HIV-1 RNA ≥ 50 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 50 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered “non-responders” on Study Day 1.|Baseline to 48 Weeks|ITT analysis set||Percentage of Participants|||Number
705658|NCT00112047|Secondary|Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) at Week 48|TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 400 c/mL or last HIV-1 RNA ≥ 400 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 400 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered “non-responders” on Study Day 1.|Baseline to 48 weeks|ITT analysis set||Percentage of Participants|||Number
705659|NCT00112047|Secondary|Percentage of Participants With HIV-1 RNA < 50 c/mL at Week 48|The percentage of participants with plasma HIV-1 RNA < 50 c/mL at Week 48. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 50 c/mL (i.e., ITT missing or switch=failure analysis).|48 Weeks|ITT analysis set (Missing Observation or Switch in ART=Failure). ITT analysis set included all randomized participants who received at least one dose of study medication, and had no major protocol violations (2 participants were not ART-naive at study start [ITT analysis set: 509]).||Percentage of Participants|||Number
705660|NCT00112047|Secondary|Percentage of Participants With Plasma HIV-1 RNA < 400 c/mL at Week 48.|The percentage of participants with plasma HIV-1 RNA < 400 c/mL at Week 48. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 400 c/mL (i.e., ITT missing or switch=failure analysis).|48 weeks|Intention to Treat (ITT) analysis set (Missing Observation or Switch in ART=Failure). ITT analysis set included all randomized participants who received at least one dose of study medication, and had no major protocol violations (2 participants were not ART-naive at study start [ITT analysis set: 509]).||Percentage of Participants|||Number
705680|NCT00112112|Secondary|T- and B-lymphocyte Subsets by Flow Cytometry - White Blood Cells|Mean and standard deviation results of white blood cells subsets is reported.|7-10 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.||cells per 10^3/UL||Standard Deviation|Mean
705661|NCT00112047|Secondary|Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 48 (Defined by FDA TLOVR Algorithm)|Participants who achieved/maintained confirmed HIV-1 RNA < 50 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 48 visit; 2) achieved confirmed HIV-1 RNA < 50 c/mL on 2 consecutive visits prior to Week 48 visit (that is, the first of the 2 consecutive HIV-1 RNA < 50 c/mL occurred prior to the Week 48 visit; 3) not had confirmed HIV-1 RNA > 50 c/mL after achievement of confirmed HIV RNA levels < 50 c/mL prior to Week 48 visit.|Week 48|MITT analysis set included all randomized participants who received at least one dose of study medication, had no major protocol violations, and no baseline primary NNRTI resistance mutations (2 participants were not ART-naive at study start; 22 participants had NNRTI resistance mutations at baseline [MITT analysis set: 487])||Percentage of Participants|||Number
705662|NCT00112047|Primary|Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 48 (Defined by the Food and Drug Administration [FDA] Time-to-Loss-of Virologic Response [TLOVR] Algorithm|Participants who achieved/maintained confirmed HIV-1 RNA < 400 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 48 visit; 2) achieved confirmed HIV-1 RNA < 400 c/mL on 2 consecutive visits prior to Week 48 visit (ie, the first of the 2 consecutive HIV-1 RNA < 400 c/mL occurred prior to the Week 48 visit; 3) not had confirmed HIV-1 RNA > 400 c/mL after achievement of confirmed HIV RNA levels < 400 c/mL prior to Week 48 visit.|48 weeks|Modified intention to treat (MITT) analysis set included all randomized participants who received at least 1 dose of study treatment, no major protocol violations, and no baseline primary NNRTI resistance mutation (2 participants were not ART-naive at study start; 22 participants had NNRTI resistance mutations at baseline [MITT analysis set: 487])||Percentage of participants|||Number
705663|NCT00112112|Secondary|Influenza B IgM|Mean of influenza-specific IgM from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|35-42 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.||titer||Standard Deviation|Mean
705664|NCT00112112|Secondary|Influenza B IgM|Mean of influenza-specific IgM from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|pre-dosing (Day 0)|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.||titer||Standard Deviation|Mean
705665|NCT00112112|Secondary|Influenza A/H3N2 IgM|Mean of influenza-specific IgM from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|35-42 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.||titer||Standard Deviation|Mean
705666|NCT00112112|Secondary|Influenza A/H3N2 IgM|Mean of influenza-specific IgM from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|pre-dosing (Day 0)|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.||titer||Standard Deviation|Mean
705667|NCT00112112|Secondary|Influenza A/H1N1 IgM|Mean of influenza-specific IgM from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|35-42 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.||titer||Standard Deviation|Mean
705668|NCT00112112|Secondary|Influenza A/H1N1 Immunoglobulin M (IgM)|Mean of influenza-specific IgM from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|pre-dosing (Day 0)|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.||titer||Standard Deviation|Mean
705669|NCT00112112|Secondary|Influenza B IgG|Mean of influenza-specific IgG from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|35-42 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.||titer||Standard Deviation|Mean
705670|NCT00112112|Secondary|Influenza B IgG|Mean of influenza-specific IgG from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|pre-dosing (Day 0)|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.||titer||Standard Deviation|Mean
705671|NCT00112112|Secondary|Influenza A/H3N2 IgG|Mean of influenza-specific IgG from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|35-42 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.||titer||Standard Deviation|Mean
705672|NCT00112112|Secondary|Influenza A/H3N2 IgG|Mean of influenza-specific IgG from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|pre-dosing (Day 0)|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.||titer||Standard Deviation|Mean
705673|NCT00112112|Secondary|Influenza A/H1N1 IgG|Mean of influenza-specific IgG from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|35-42 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.||titer||Standard Deviation|Mean
705674|NCT00112112|Secondary|Influenza A/H1N1 Immunoglobulin G (IgG)|Mean of influenza-specific IgG from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|pre-dosing (Day 0)|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.||titer||Standard Deviation|Mean
705681|NCT00112112|Secondary|T- and B-lymphocyte Subsets by Flow Cytometry - White Blood Cells|Mean and standard deviation results of white blood cells subsets is reported.|pre-dosing (Day 0)|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.||cells per 10^3/UL||Standard Deviation|Mean
705682|NCT00112112|Secondary|T- and B-lymphocyte Subsets by Flow Cytometry - CD56|Mean and standard deviation results of CD56 lymphocyte subsets is reported.|7-10 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.||percent of lymphocytes||Standard Deviation|Mean
705683|NCT00112112|Secondary|T- and B-lymphocyte Subsets by Flow Cytometry - CD56|Mean and standard deviation results of CD56 lymphocyte subsets is reported.|pre-dosing (Day 0)|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.||percent of lymphocytes||Standard Deviation|Mean
705684|NCT00112112|Secondary|Influenza B IgA|Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|35-42 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.||titer||Standard Deviation|Mean
705685|NCT00112112|Secondary|Influenza B IgA|Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|14-28 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.||titer||Standard Deviation|Mean
705686|NCT00112112|Secondary|Influenza B IgA|Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|7-10 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.||titer||Standard Deviation|Mean
705687|NCT00112112|Secondary|Influenza B IgA|Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|3-5 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.||titer||Standard Deviation|Mean
705688|NCT00112112|Secondary|Influenza B IgA|Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|pre-dosing (Day 0)|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.||titer||Standard Deviation|Mean
705689|NCT00112112|Secondary|Influenza A/H3N2 IgA|Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|35-42 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.||titer||Standard Deviation|Mean
705690|NCT00112112|Secondary|Influenza A/H3N2 IgA|Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|14-28 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.||titer||Standard Deviation|Mean
705691|NCT00112112|Secondary|Influenza A/H3N2 IgA|Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|7-10 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.||titer||Standard Deviation|Mean
705692|NCT00112112|Secondary|Influenza A/H3N2 IgA|Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|3-5 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.||titer||Standard Deviation|Mean
705693|NCT00112112|Secondary|Influenza A/H3N2 IgA|Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|pre-dosing (Day 0)|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.||titer||Standard Deviation|Mean
705694|NCT00112112|Secondary|Influenza A/H1N1 IgA|Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|35-42 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.||titer||Standard Deviation|Mean
705695|NCT00112112|Secondary|Influenza A/H1N1 IgA|Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|14-28 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.||titer||Standard Deviation|Mean
705696|NCT00112112|Secondary|Influenza A/H1N1 IgA|Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|7-10 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.||titer||Standard Deviation|Mean
705697|NCT00112112|Secondary|Influenza A/H1N1 IgA|Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|3-5 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.||titer||Standard Deviation|Mean
705698|NCT00112112|Secondary|Influenza A/H1N1 Immunoglobulin A (IgA)|Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|pre-dosing (Day 0)|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.||titer||Standard Deviation|Mean
705699|NCT00112112|Secondary|Number of Participants Who Experienced a >= 4-fold Rise in Influenza B Microneutralization Titers From Baseline to Day 35-42|Participants with a geometric mean fold-rise in influenza-specific nasal microneutralization titers >= 4 from baseline are reported.|Baseline (pre-dosing on Day 0) and 35-42 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the samples available for the specified days were analysed.||participants|||Number
705700|NCT00112112|Secondary|Number of Participants Who Experienced a >= 4-fold Rise in Influenza A/H3N2 Microneutralization Titers From Baseline to Day 35-42|Participants with a geometric mean fold-rise in influenza-specific nasal microneutralization titers >= 4 from baseline are reported.|Baseline (pre-dosing on Day 0) and 35-42 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the samples available for the specified days were analysed.||participants|||Number
705701|NCT00112112|Secondary|Number of Participants Who Experienced a >= 4-fold Rise in Influenza A/H1N1 Microneutralization Titers From Baseline to Day 35-42|Participants with a geometric mean fold-rise in influenza-specific nasal microneutralization titers >= 4 from baseline are reported.|Baseline (pre-dosing on Day 0) and 35-42 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the samples available for the specified days were analysed.||participants|||Number
705702|NCT00112112|Secondary|Number of Participants Who Experienced a >= 4-fold Rise in Serum Influenza B HAI Titers From Baseline to Day 35-42|Participants with a geometric mean fold-rise in influenza-specific nasal HAI titers >= 4 from baseline are reported.|Baseline (pre-dosing on Day 0) and 35-42 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the samples available for the specified days were analysed.||participants|||Number
705703|NCT00112112|Secondary|Number of Participants Who Experienced a >= 4-fold Rise in Serum Influenza A/H3N2 HAI Titers From Baseline to Day 35-42|Participants with a geometric mean fold-rise in influenza-specific nasal HAI titers >= 4 from baseline are reported.|Baseline (pre-dosing on Day 0) and 35-42 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the samples available for the specified days were analysed.||participants|||Number
705704|NCT00112112|Secondary|Number of Participants Who Experienced a >= 4-fold Rise in Serum Influenza A/H1N1 Hemagglutination Inhibition (HAI) Titers From Baseline to Day 35-42|Participants with a geometric mean fold-rise in influenza-specific nasal HAI titers >= 4 from baseline are reported.|Baseline (pre-dosing on Day 0) and 35-42 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the samples available for the specified days were analysed.||participants|||Number
705705|NCT00112112|Secondary|HLA Matched Tetramers CD8+|The antigen-specific response of the T cell populations was measured using HLA-matched tetramers specific for human CD8 cell populations.|35-42 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.||Percentage of lymphocytes||Standard Deviation|Mean
705706|NCT00112112|Secondary|HLA Matched Tetramers CD8+|The antigen-specific response of the T cell populations was measured using HLA-matched tetramers specific for human CD8 cell populations.|7-10 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.||Percentage of lymphocytes||Standard Deviation|Mean
705707|NCT00112112|Secondary|Human Leukocyte Antigen (HLA) Matched Tetramers CD8+|The antigen-specific response of the T cell populations was measured using HLA-matched tetramers specific for human CD8 cell populations.|pre-dosing (Day 0)|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.||Percentage of lymphocytes||Standard Deviation|Mean
705708|NCT00112112|Secondary|IL-4|Mean and standard deviation spots-forming cells per 10^5 T cells is reported.|35-42 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.||cells per 10^5 T cells||Standard Deviation|Mean
705709|NCT00112112|Secondary|IL-4|Mean and standard deviation spots-forming cells per 10^5 T cells is reported.|7-10 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.||cells per 10^5 T cells||Standard Deviation|Mean
705710|NCT00112112|Secondary|Interleukin (IL)-4|Mean and standard deviation spots-forming cells per 10^5 T cells is reported.|pre-dosing (Day 0)|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.||cells per 10^5 T cells||Standard Deviation|Mean
705711|NCT00112112|Secondary|INF-Gamma|Mean and standard deviation spots-forming cells per 10^5 T cells is reported.|35-42 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.||cells per 10^5 T cells||Standard Deviation|Mean
705918|NCT00113087|Secondary|Neurodevelopmental Status(MDI): Bayley Scales of Infant Development, Mental Developmental Index Z-score|Neurodevelopmental status(MDI):Bayley Scales of infant development, Mental Developmental Index z-score .|at 14 months of age|ITT, not imputation||standard deviation||Standard Deviation|Mean
705712|NCT00112112|Secondary|INF-Gamma|Mean and standard deviation spots-forming cells per 10^5 T cells is reported.|7-10 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.||cells per 10^5 T cells||Standard Deviation|Mean
705713|NCT00112112|Secondary|Interferon (INF)-Gamma|Mean and standard deviation spots-forming cells per 10^5 T cells is reported.|pre-dosing (Day 0)|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.||cells per 10^5 T cells||Standard Deviation|Mean
705714|NCT00112112|Secondary|T- and B-lymphocyte Subsets by Flow Cytometry - CD8|Mean and standard deviation results of CD8 lymphocyte subsets as a percentage of total lymphocytes.|7-10 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.||percentage of lymphocytes||Standard Deviation|Mean
705715|NCT00112112|Secondary|T- and B-lymphocyte Subsets by Flow Cytometry - CD4|Mean and standard deviation results of CD4 lymphocyte subsets as a percentage of total lymphocytes.|7-10 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.||percentage of lymphocytes||Standard Deviation|Mean
705716|NCT00112112|Secondary|T- and B-lymphocyte Subsets by Flow Cytometry - CD3|Mean and standard deviation results of CD3 lymphocyte subsets as a percentage of total lymphocytes.|7-10 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.||percentage of lymphocytes||Standard Deviation|Mean
705717|NCT00112112|Secondary|T- and B-lymphocyte Subsets by Flow Cytometry - CD19|Mean and standard deviation results of CD19 lymphocyte subsets as a percentage of total lymphocytes.|7-10 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.||percentage of lymphocytes||Standard Deviation|Mean
705718|NCT00112112|Secondary|T- and B-lymphocyte Subsets by Flow Cytometry - CD8|Mean and standard deviation results of CD8 lymphocyte subsets as a percentage of total lymphocytes.|pre-dosing (Day 0)|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.||percentage of lymphocytes||Standard Deviation|Mean
705719|NCT00112112|Secondary|T- and B-lymphocyte Subsets by Flow Cytometry - CD4|Mean and standard deviation results of CD4 lymphocyte subsets as a percentage of total lymphocytes.|pre-dosing (Day 0)|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.||percentage of lymphocytes||Standard Deviation|Mean
705720|NCT00112112|Secondary|T- and B-lymphocyte Subsets by Flow Cytometry - CD3|Mean and standard deviation results of CD3 lymphocyte subsets as a percentage of total lymphocytes.|pre-dosing (Day 0)|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.||percentage of lymphocytes||Standard Deviation|Mean
705721|NCT00112112|Secondary|T- and B-lymphocyte Subsets by Flow Cytometry - Cluster of Differentiation (CD) 19|Mean and standard deviation results of CD19 lymphocyte subsets as a percentage of total lymphocytes.|pre-dosing (Day 0)|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.||percentage of lymphocytes||Standard Deviation|Mean
705722|NCT00112112|Secondary|Number of Participants Shedding Vaccine-like Virus|Number of participants with nasal swab samples that contained vaccine-like virus are reported.|Unscheduled visits occurring during 0-42 days after study vaccination|Participants who received any study vaccine and had any follow-up for REs and/or AEs.||participants|participants w/unsched. illness visits||Number
705723|NCT00112112|Secondary|Number of Participants Shedding Vaccine-like Virus|Number of participants with nasal swab samples that contained vaccine-like virus are reported. Sample was collected at this time point only if health assessment indicated presence of a respiratory illness, including otitis media.|35-42 days after study vaccination|Participants who received any study vaccine and had any follow-up for REs and/or AEs.||participants|||Number
705724|NCT00112112|Secondary|Number of Participants Shedding Vaccine-like Virus|Number of participants with nasal swab samples that contained vaccine-like virus are reported.|14-28 days after study vaccination|Participants who received any study vaccine and had any follow-up for REs and/or AEs.||participants|||Number
705725|NCT00112112|Secondary|Number of Participants Shedding Vaccine-like Virus|Number of participants with nasal swab samples that contained vaccine-like virus are reported.|7-10 days after study vaccination|Participants who received any study vaccine and had any follow-up for REs and/or AEs.||participants|||Number
705726|NCT00112112|Secondary|Number of Participants Shedding Vaccine-like Virus|Number of participants with nasal swab samples that contained vaccine-like virus are reported.|3-5 days after study vaccination|Participants who received any study vaccine and had any follow-up for REs and/or AEs.||participants|||Number
705727|NCT00112112|Primary|Number of Significant New Medical Conditions (SNMCs)|A significant new medical condition is defined as a new diagnosis of a chronic medical condition that does not meet the criteria of a SAE.|43-180 days after study vaccination|Participants who received any study vaccine and had any follow-up for REs and/or AEs.||events|||Number
705728|NCT00112112|Primary|Number of Participants Who Had Adverse Events (AEs)|An AE is any untoward medical occurrence in a patient or clinical investigations study participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|0-42 days after study vaccination|Participants who received any study vaccine and had any follow-up for REs and/or AEs.||participants|||Number
705729|NCT00112112|Primary|Number of Participants Who Had Serious Adverse Events (SAEs)|An SAE is any AE that results in any of the following outcomes: •Death • Life-threatening • Inpatient hospitalization or prolongation of existing hospitalization • Persistent or significant disability or incapacity • Congenital anomaly/birth defect (in the offspring of a study participant) • An important medical event that may may jeopardize the study participant and may require medical or surgical intervention to prevent one of the outcomes listed above.|0-180 days after study vaccination|Participants who received any study vaccine and had any follow-up for REs and/or AEs.||Participants|||Number
705730|NCT00112112|Primary|Number of Participants Who Had Reactogenicity Events (REs)|Reactogenicity events (REs) are predefined solicited adverse events (AEs) that can potentially occur after vaccine administration. The REs for this study included fever, runny nose/nasal congestion, sore throat, cough, vomiting, headache, muscle aches, chills, tiredness, and irritability.|0-42 days after study vaccination|Participants who received any study vaccine and had any follow-up for REs and/or AEs. One participant in FluMist group did not have any RE data and was excluded from the RE analysis.||participants|||Number
705731|NCT00112151|Secondary|Fat Free Mass (kg)|Total change in Fat free mass (kg) as evaluated by DXA|Baseline and 12 months|||kg||Standard Deviation|Mean
705732|NCT00112151|Secondary|Fat Mass (kg)|Total change in Fat mass (kg) as evaluated by DXA|Baseline and 12 months|||kg||Standard Deviation|Mean
705733|NCT00112151|Secondary|Power (Power Rig, Watts)|Leg extensor power was evaluated using a Nottingham leg extensor power rig (watts).|Baseline and 12 months|||Watts||Standard Deviation|Mean
705734|NCT00112151|Secondary|Lower Body Muscle Strength (1-RM, kg)|The maximal weight a participant could lift once [1-repetition maximum, 1-RM] was assessed at baseline and 12 months. The average of the difference from baseline in 3 lower-body 1-RM measures (knee extension, knee flexion, and seated leg press)) are represented.|Baseline and 12 months|||kg||Standard Deviation|Mean
705735|NCT00112151|Secondary|Upper Body Muscle Strength (1-RM, kg)|The maximal weight a participant could lift once (1-repetition maximum, 1-RM) was assessed at baseline and 12 months. The average of the difference from baseline in 4 upper-body 1-RM measures (bench press,incline press, overhead pull-down, and seated row) are represented.|Baseline and 12 months|||kg||Standard Deviation|Mean
705736|NCT00112151|Primary|Physical Function (CS-PFP Total Score)|Continuous-scale physical function performance test (CS-PFP) which comprises 15 everyday tasks requiring upper and lower body strength and flexibility, balance, coordination and endurance. The CS-PFP was developed to measure performance in higher functioning adults with minimal floor or ceiling effects, and is valid, reliable and sensitive to change. Total and domain scores are scaled from 0 to 100, with higher scores indicating better function.|Baseline and 12 months|||units on a scale||Standard Deviation|Mean
705737|NCT00112294|Secondary|Number of Participants Who Had Unscheduled Visits to Physicians, Clinics, Hospitals and Other Unscheduled Major Medicinal Procedures|Participants were to complete log to collect information on unscheduled visits to physicians,clinics,hospitals & other unscheduled major procedures.If asked, participants were to complete and return log to site upon routinely scheduled visits.The purpose of this exploratory analysis was to understand the economical implications as a secondary objective.This was not a pivotal study & therefore not needed to support any arguments with regulatory authorities concerning cost-benefit,hence,it was not necessary to conduct this analysis. There is no intent on conducting this analysis in the future.|Day 1 of each cycle of treatment, at the end of study therapy evaluation and at the first follow-up visit (6 weeks after the end of study therapy evaluation).|This analysis was not performed.|||||
705738|NCT00112294|Secondary|Number of Participants Who Experienced the Most Frequent Grade 3-4 Serum Chemistry Abnormalities Occurring in >=5% Participants|Abnormalities were graded according to the NCI CTC, version 3.0. The scale is graded from 1 (least severe) to 4 (life threatening). Grade 3 and 4 criteria are defined as follows: Hyperglycemia (non-fasting): Grade 3, serum glucose >13.9 – 27.8 mmol/L; Grade 4 >27.8 mmol/L or acidosis. Hypomagnesemia: Grade 3, serum magnesium >1.23 – 3.30 mmol/L; Grade 4 >3.30 mmol/L. Hyponatremia: Grade 3, serum sodium <130 – 120 mmol/L; Grade 4 <120 mmol/L. Low albumin: Grade 3, serum albumin <20 g/L; Grade 4 not applicable.|From start of study drug therapy up to 30 days after the last dose (up to 178 weeks).|All treated participants.||Participants|||Number
705739|NCT00112294|Other Pre-specified|Median Change From Baseline in Symptoms, by Time Point|Symptoms were assessed using the FACT-LCS questionnaire. This 7-item scale has scores ranging from 0 (severely symptomatic) to 28 (symptom-free). The median change from baseline score was calculated at 3-weekly intervals. See also Outcome Measure 8.|From randomization to evidence of disease progression/death or date of last symptom assessment (up to 33 weeks).|All randomized participants who completed a baseline FACT-LCS questionnaire (ie, completed questionnaire <=14 days prior to treatment, or if they were never treated, <=14 days prior to randomization). n = number of participants with a score at both the baseline and at the specified time point (each arm respectively).||Units on a scale||Inter-Quartile Range|Median
705740|NCT00112294|Secondary|Number of Participants Who Exprienced the Most Frequent Grade 3-4 Hematology Abnormalities Occurring in >=5% Participants|Abnormalities were graded according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 3.0. The scale is graded from 1 (least severe) to 4 (life threatening). Grade 3 and 4 criteria are defined as follows: Neutropenia: Grade 3, neutrophils <1.0 - 0.5 x 10^9/L; Grade 4, <0.5 x 10^9/L. Leukopenia: Grade 3, leukocytes <2.0 – 1.0 x 10^9/L; Grade 4, <1.0 x 10^9/L. Thrombocytopenia: Grade 3, platelets <50.0 – 25.0 x 10^9/L; Grade 4, <25.0 x 10^9/L. Anemia: Grade 3, hemoglobin <4.9 – 4.0 millimoles (mmol)/L, Grade 4, <4.0 mmol/L.|From start of study drug therapy up to 30 days after the last dose (up to 178 weeks).|All treated participants.||Participants|||Number
705741|NCT00112294|Secondary|Number of Participants Experiencing Other Significant AEs: Cardiac AEs|An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition (even if not caused by the study drug). For this study, it was decided that AEs that were categorized under the composite term “cardiac AE” were of particular importance. These AEs, coded as preferred or other level Medical Dictionary for Regulatory Activities [MedDRA] terms were: coronary artery disorders, cardiac arrhythmias, heart failures not elsewhere classified, left ventricular failures, sudden cardiac death, cardiac death and sudden death.|From start of study drug therapy up to 30 days after the last dose (up to 178 weeks).|All treated participants.||Participants|||Number
706687|NCT00110396|Secondary|Number of Participants With Binding Antibodies (BAb) at Week 96|Presence of BAbs. BAbs were measured by ELISA (Enzyme-linked immunosorbent assay).|96 weeks|ITT (One participant did not have any post-baseline NAb assessments) LOCF imputation||Participants|||Number
705742|NCT00112294|Secondary|Number of Participants Experiencing Other Significant AEs: Infusion Reaction|"AE=any new untoward medical occurrence or worsening of pre-existing medical condition (even if not caused by the study drug). For this study, it was decided that AEs that were categorized under the composite term infusion reaction were of particular importance. These AEs were: infusion-related reaction, hypersensitivity, anaphylactic reaction, anaphylactic shock, and anaphylactoid reaction regardless of when they occurred. The terms dyspnea, pyrexia and chills were also grouped under infusion reaction, provided the onset date of these toxicities occurred on the first day of study treatment."|From start of study drug therapy up to 30 days after the last dose (up to 178 weeks).|All treated participants.||Participants|||Number
705743|NCT00112294|Secondary|Number of Participants Experiencing Other Significant AEs: Acneform Rash|An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition (even if not caused by the study drug). For this study, it was decided that AEs that were categorized under the composite term “acneform rash” were of particular importance. These AEs were: rash, rash pustular, rash erythematous, dermatitis acneiform, dermatitis exfoliative, rash papular, rash pruritic, rash generalised, rash macular, rash maculo-papular, acne, acne pustular, skin desquamation and dry skin.|From start of study drug therapy up to 30 days after the last dose (up to 178 weeks).|All treated participants.||Participants|||Number
705744|NCT00112294|Secondary|Number of Participants Experiencing AEs Leading to Study Drug Discontinuation|An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition (even if not caused by the study drug). The results presented are stratified according to which drug was discontinued.|From start of study drug therapy up to 30 days after the last dose (up to 178 weeks).|All treated participants.||participants|||Number
705745|NCT00112294|Secondary|Number of Participants Who Died, or Experienced Other Serious Adverse Events (SAEs) and Adverse Events (AEs)|An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition (even if not caused by the study drug). An SAE was defined as an AE that resulted in death, was life-threatening, required hospitalization (or prolongation of existing hospitalization), or was an important medical event.|From start of study drug therapy up to 30 days after the last dose (up to 178 weeks).|All treated participants. The AEs represented here include SAEs, which are not included in the AE count represented in the AE xml upload section. As such, these numbers may not match.||Participants|||Number
705746|NCT00112294|Secondary|Median Number of Months Until Symptomatic Progression (Worsening of Symptoms)|Symptoms were assessed using the FACT-LCS questionnaire. This 7-item scale has scores ranging from 0 (severely symptomatic) to 28 (symptom-free). Symptomatic progression was defined as >= 2-point decrease from baseline in score (maintained for 2 consecutive assessments at least 3 weeks apart). Time to symptomatic progression was defined as the time from randomization to date of symptoms worsening. For participants with no symptom progression, the date of the last symptom assessment was used. See also Outcome Measure 15.|From randomization to evidence of disease progression/death or date of last symptom assessment (up to 33 weeks).|All randomized participants who completed baseline FACT-LCS questionnaire (ie, completed questionnaire <=14 days prior to treatment, or if they were never treated, <=14 days prior to randomization) and who had a baseline score greater than or equal to 2. As the median was not reached, no data are presented here (see Outcome Measure 15).|||||
705747|NCT00112294|Secondary|Number of Participants With Improvement of Symptoms|Symptoms were assessed using the Functional Assessment of Cancer Therapy – Lung Cancer Subscale (FACT-LCS) questionnaire. This 7-item scale has scores ranging from 0 (severely symptomatic in all symptoms assessed) to 28 (symptom-free on all symptoms assessed). Symptom response (improvement) was defined as >= 2-point increase from baseline in score (maintained for 2 consecutive assessments, at least 3 weeks apart). Participants with a baseline score of >= 27 were not evaluable, as it would not have been possible to show an improvement. Participants with no baseline data were also not evaluable.|From randomization to evidence of disease progression/death or date of last symptom assessment (up to 33 weeks).|All randomized participants who completed a baseline FACT-LCS questionnaire (ie, who completed a questionnaire <=14 days prior to treatment, or if they were never treated, <=14 days prior to randomization) and who had a baseline score of 26 or less.||Participants|||Number
705748|NCT00112294|Secondary|Median Number of Months of Survival|The median number of months of survival was defined as the time from randomization to the date of death. For participants who did not die, the date of last contact was used.|From randomization to death or date of last contact (up to 41 months).|All randomized participants (intention to treat population).||Months||95% Confidence Interval|Median
705749|NCT00112294|Secondary|Median Number of Months to Response|The median number of months to response was calculated for participants whose best response was CR or PR. It was defined as the time from the first dose of study therapy to the first date that criteria for PR or CR (whichever occurred first)were met. Response was assessed by the IRRC, using the modified WHO criteria: CR: disappearance of all index/non-index lesions; PR: >= 50% reduction in the SOPD of index lesions compared with the baseline SOPD, with no evidence of progression. To qualify as CR or PR, no new lesions could be present.|Time from first dose of study therapy to the date of PR or CR, whichever occurred first (up to 13 months).|All randomized participants with a best response of CR or PR.||Months||Full Range|Median
705750|NCT00112294|Secondary|Median Number of Months of Response|Median number of months of response (time from first occurrence of CR/PR to date of PD/death, [per IRRC assessment,using modified WHO criteria]) calculated for participants whose best response=CR/PR.For participants who did not progress/die, date of last tumor assessment used.CR:disappearance of all index/non-index lesions;PR:>= 50% reduction in SOPD of index lesions compared with baseline, no evidence of progression.No new lesions present.PD:>=25% increase in SOPD of lesions compared with smallest SOPD recorded for study period or progression of any non-index lesion/appearance of new lesion.|Time from first occurrence of CR or PR (whichever was recorded first) to the date of PD, death or date of last tumor assessment (up to 19 months).|All randomized participants with a best response of CR or PR.||Months||95% Confidence Interval|Median
705761|NCT00112359|Other Pre-specified|Number of Participants With Other Pathogens Present|Sputum samples were collected at all visits for quantitative and qualitative culture for Staphylococcus aureus, Burkholderia cepacia, Stenotrophomonas maltophilia, Achromobacter xylosoxidans.|Day 0 to Day 28|Analysis based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug). Participants were summarized by the actual treatment received. No imputation methods were used for the analysis.||participants|||Number
705751|NCT00112294|Secondary|Number of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD)|Disease control was defined as the number of participants whose best response was CR, PR, or SD, per the IRRC assessment, using the modified WHO criteria: CR: disappearance of all index/non-index lesions; PR:>= 50% reduction in the SOPD of index lesions compared with the baseline SOPD, with no evidence of progression (to qualify as CR or PR, no new lesions could be present); SD: participants who did not meet the criteria for CR, PR, or PD (PD:>=25% increase in SOPD of lesions compared with smallest SOPD recorded for study period or progression of any non-index lesion/appearance of new lesion).|From randomization to end of study drug therapy (up to 174 weeks).|All randomized participants (intention to treat population).||Participants|||Number
705752|NCT00112294|Secondary|Number of Participants With Complete Response (CR) or Partial Response (PR)|Tumor response was defined as the number of participants whose best response was CR or PR, per the IRRC assessment, using the modified WHO criteria: CR: disappearance of all index/non-index lesions; PR: >= 50% reduction in the SOPD of index lesions compared with the baseline SOPD, with no evidence of progression. To qualify as CR or PR, no new lesions could be present.|From randomization to end of study drug therapy (up to 174 weeks).|All randomized participants (intention to treat population).||Participants|||Number
705753|NCT00112294|Primary|Median Number of Months of Progression-free Survival (PFS)|Interval between randomization date & earliest date of disease progression/death due to any cause, assessed by the Independent Radiology Review Committee (IRRC) using modified World Health Organization (WHO) criteria to define progressive disease (PD): >=25% increase in sum of products of diameters (SOPD) of lesions compared with smallest SOPD recorded for study period or progression of any non-index lesion/appearance of new lesion. If no progression/death, date of last tumor assessment used. For participants who had no on-study tumor assessments & were still alive, date of randomization used.|From randomization to evidence of disease progression/death or date of last tumor assessment (up to 26 months).|All randomized participants (intention to treat population).||Months||95% Confidence Interval|Median
705754|NCT00112359|Other Pre-specified|Minimum Inhibitory Concentration of Aztreonam Inhibiting 50% (MIC50) and 90% (MIC90) of All PA Isolates (μg/mL)|"PA isolates from sputum samples (collected at all visits) were assessed for their susceptibility to aztreonam.
MIC50 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 50% of isolates from a particular organism).
MIC90 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 90% of isolates from a particular organism).
MIC50 and MIC90 values are single measurements for the entire population and not measured on a per-participant basis."|Day 28|Analysis based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug). Participants were summarized by the actual treatment received. No imputation methods were used for the analysis.||μg/mL|Participants||Number
705755|NCT00112359|Secondary|Number of Participants Hospitalized at Least Once Between Day 0 and Day 42|Details of all hospitalizations, including the dates of admission and discharge, were recorded on the SAE eCRF.|Day 0 to Day 42|Analysis based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug). Participants were summarized by the actual treatment received. No imputation methods were used for the analysis.||participants|||Number
705756|NCT00112359|Primary|Change in CFQ-R Respiratory Symptoms Scale (RSS) Score|The CFQ-R was administered at baseline and every visit thereafter. The endpoint was change in respiratory symptoms from baseline, assessed with the CFQ-R respiratory symptoms scale (RSS; range of scores: 0-100; higher scores indicate fewer symptoms).|Day 0 to Day 28|ITT population: participants randomized to treatment who received at least part of 1 dose of study drug. Participants summarized by actual treatment received. Missing baseline data not imputed. Missing post-baseline data imputed using worst-case value for withdrawals due to AE or study drug intolerance. All other missing data: LOCF method used.||units on a scale||Standard Error|Least Squares Mean
705757|NCT00112359|Secondary|Number of Participants Receiving Intravenous (IV) or Inhaled Antipseudomonal Antibiotics Other Than Trial Drug|Use of IV and inhaled antipseudomonal antibiotics was compiled from data recorded on the Concomitant Medications eCRF.|Day 0 to Day 42|Analysis based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug). Participants were summarized by the actual treatment received.||participants|||Number
705758|NCT00112359|Secondary|Change From Baseline in Pseudomonas Aeruginosa (PA) Log10 Colony Forming Units (CFU) Per Gram of Sputum|Sputum samples were collected at all participant visits of the study for analysis of microbiology endpoints. Sputum samples were processed for qualitative and quantitative culture of PA (each morphotype). Due to the skewness of the distribution of CFU data, the data were transformed using the base 10 logarithm, in an attempt to normalize the data and allow for parametric tests, before calculating changes. To account for zero values, 1 was added to each CFU measurement before being transformed. Any CFU data values where PA was not isolated from a valid culture were set to zero.|Day 0 to Day 28|Analysis based on ITT population (all participants randomized to treatment who received at least part of 1 dose of study drug). Participants were summarized by the actual treatment received. No imputation methods were used for the analysis.||Log10 PA CFUs/gram of sputum||Standard Error|Least Squares Mean
705759|NCT00112359|Secondary|Percent Change in FEV1 (L)|Spirometry was performed according to American Thoracic Society (ATS) guidelines at each visit. The percent change from baseline in forced expiratory volume (liters) in one second (FEV1) was determined at Day 28.|Day 0 to Day 28|ITT population: participants randomized to treatment who received at least part of 1 dose of study drug. Participants summarized by actual treatment received. Missing baseline data not imputed. Missing post-baseline data imputed using worst-case value for withdrawals due to AE or study drug intolerance. All other missing data: LOCF method used.||Percent change in FEV1 (L)||Standard Error|Least Squares Mean
705760|NCT00112359|Other Pre-specified|Minimum Inhibitory Concentration of Aztreonam Inhibiting 50% (MIC50) and 90% (MIC90) of All PA Isolates (μg/mL)|"PA isolates from sputum samples (collected at all visits) were assessed for their susceptibility to aztreonam.
MIC50 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 50% of isolates from a particular organism).
MIC90 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 90% of isolates from a particular organism).
MIC50 and MIC90 values are single measurements for the entire population and not measured on a per-participant basis."|Day 0|Analysis based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug). Participants were summarized by the actual treatment received. No imputation methods were used for the analysis.||μg/mL|Participants||Number
705762|NCT00112359|Secondary|Change in CFQ-R RSS Score|The CFQ-R was administered at baseline and every visit thereafter. The endpoint was change in respiratory symptoms from baseline, assessed with the CFQ-R RSS (range of scores: 0-100; higher scores indicate fewer symptoms).|Day 0 to Day 42|ITT population: participants randomized to treatment who received at least part of 1 dose of study drug. Participants summarized by actual treatment received. Missing baseline data not imputed. Missing post-baseline data imputed using worst-case value for withdrawals due to AE or study drug intolerance. All other missing data: LOCF method used.||units on a scale||Standard Error|Least Squares Mean
705763|NCT00112359|Secondary|Change in CFQ-R RSS Score|The CFQ-R was administered at baseline and every visit thereafter. The endpoint was change in respiratory symptoms from baseline, assessed with the CFQ-R RSS (range of scores: 0-100; higher scores indicate fewer symptoms).|Day 0 to Day 14|ITT population: participants randomized to treatment who received at least part of 1 dose of study drug. Participants summarized by actual treatment received. Missing baseline data not imputed. Missing post-baseline data imputed using worst-case value for withdrawals due to AE or study drug intolerance. All other missing data: LOCF method used.||units on a scale||Standard Error|Least Squares Mean
705764|NCT00112385|Secondary|Average Daily Dose of Prednisone From Baseline to Week 52|The average daily dose of prednisone from baseline to week 52 was calculated by treatment group.|Baseline through Week 52|||mg||Standard Deviation|Mean
705765|NCT00112385|Primary|Average Cumulative Dosage of Prednisone Over the One Year Study Period|The average cumulative dosage of prednisone over the one year period of the study was calculated. The results are presented by treatment group.|Baseline until week 52|||mg||Standard Deviation|Mean
705766|NCT00112385|Primary|Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Monoclonal Protein Detection by Serum Protein Electrophoresis (SPEP) From the Screening Visit to Week 52|"The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.
A subject was considered to have a treatment emergent, clinically significant value if during the course of the study, they had at least one clinically significant monoclonal protein value that was not present at baseline. Subjects had monoclonal protein labs collected at Screening, Week 12, 24, 40, and 52."|Screening visit, Week 12, 24, 40, and 52|"Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.
Data may also be missing due to the subject's refusal to complete an assessment or examiner error."||participants|||Number
705767|NCT00112385|Primary|Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Antinuclear Antibody Test (ANA) Values From the Screening Visit to Week 52|"The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.
A subject was considered to have a treatment emergent, clinically significant value if during the course of the study, they had at least one clinically significant Antinuclear Antibody Test (ANA) result that was not present at baseline. Subjects had ANA labs collected at Screening, Week 12, 24, 40, and 52."|At Screening, Week 12, 24, 40, and 52|"Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.
Data may also be missing due to the subject's refusal to complete an assessment or examiner error."||participants|||Number
705768|NCT00112385|Primary|Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Serum 25-hydroxyvitamin D (25-OH VitD) Laboratory Values From the Screening Visit to Week 52|"The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.
A subject was considered to have a treatment emergent, clinically significant value if during the course of the study, they had at least one clinically significant serum 25-hydroxyvitamin D (25-OH VitD) result that was not present at baseline. Subjects had 25-OH VitD labs collected at Screening and at the Week 52 visit."|Screening visit and Week 52|"Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.
Data may also be missing due to the subject's refusal to complete an assessment or examiner error."||participants|||Number
705769|NCT00112385|Primary|Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Urine Ketone Laboratory Values From Baseline to Week 52|"The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.
A subject was considered to have a treatment emergent, clinically significant value if during the course of the study, they had at least one clinically significant urine ketone result that was not present at baseline. Subjects had urine ketone labs collected at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52."|At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52|"Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.
Data may also be missing due to the subject's refusal to complete an assessment or examiner error."||participants|||Number
705770|NCT00112385|Primary|Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Urine Glucose Laboratory Values From Baseline to Week 52|"The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.
A subject was considered to have a treatment emergent, clinically significant value if during the course of the study, they had at least one clinically significant urine glucose result that was not present at baseline. Subjects had urine glucose labs collected at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52."|At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52|"Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.
Data may also be missing due to the subject's refusal to complete an assessment or examiner error."||participants|||Number
705771|NCT00112385|Primary|Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Urine Protein Laboratory Values From Baseline to Week 52|"The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.
A subject was considered to have a treatment emergent, clinically significant value if during the course of the study, they had at least one clinically significant urine protein result that was not present at baseline. Subjects had urine protein labs collected at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52."|At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52|"Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.
Data may also be missing due to the subject's refusal to complete an assessment or examiner error."||participants|||Number
705772|NCT00112385|Primary|Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Urine Leukocyte Values From Baseline to Week 52|"The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.
A subject was considered to have a treatment emergent, clinically significant value if during the course of the study, they had at least 1 clinically significant urine leukocyte result that was not present at baseline. Subjects had urine leukocyte labs collected at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52."|At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52|"Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.
Data may also be missing due to the subject's refusal to complete an assessment or examiner error."||participants|||Number
705773|NCT00112385|Primary|Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Platelet Counts From Baseline to Week 52|"The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.
A subject was considered to have a treatment emergent, clinically significant platelet value if during the course of the study, they had at least one clinically significant platelet result that was not present at baseline. Subjects had platelet labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52."|At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52|"Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.
Data may also be missing due to the subject's refusal to complete an assessment or examiner error."||participants|||Number
705774|NCT00112385|Primary|Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Hematocrit Laboratory Values From Baseline to Week 52|"The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.
A subject was considered to have a treatment emergent, clinically significant hematocrit value if during the course of the study, they had at least one clinically significant hematocrit result that was not present at baseline. Subjects had hematocrit labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52."|At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52|"Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.
Data may also be missing due to the subject's refusal to complete an assessment or examiner error."||participants|||Number
705775|NCT00112385|Primary|Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Hemoglobin Laboratory Values From Baseline to Week 52|"The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.
A subject was considered to have a treatment emergent, clinically significant Hemoglobin value if during the course of the study, they had at least one clinically significant Hemoglobin result that was not present at baseline. Subjects had hemoglobin labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52."|At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52|"Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.
Data may also be missing due to the subject's refusal to complete an assessment or examiner error."||participants|||Number
705776|NCT00112385|Primary|Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal White Blood Cell Count (WBC) Values From Baseline to Week 52|"The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.
A subject was considered to have a treatment emergent, clinically significant White Blood Cell (WBC) value if during the course of the study, they had at least one clinically significant WBC result that was not present at baseline. Subjects had WBC labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52."|Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52|"Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.
Data may also be missing due to the subject's refusal to complete an assessment or examiner error."||participants|||Number
705800|NCT00112385|Other Pre-specified|Average Change in Time to Rise From a Chair From Baseline to Week 52|"The Average change in time to rise from a chair comparing Baseline performance to Week 52.The average change was determined by subtracting the Baseline test results from the Week 52 results (Week 52- Baseline).
This measure was also collected as part of the study protocol at Week 4, 8, 12, 16, 20, 24, 32 and 40."|At Baseline (Week0) and Week 52|Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.||Seconds||Standard Deviation|Mean
705777|NCT00112385|Primary|Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Potassium Laboratory Values From Baseline to Week 52|"The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.
A subject was considered to have a treatment emergent, clinically significant Potassium value if during the course of the study, they had at least one clinically significant Potassium result that was not present at baseline. Subjects had Potassium labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52."|Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52|"Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.
Data may also be missing due to the subject's refusal to complete an assessment or examiner error."||participants|||Number
705778|NCT00112385|Primary|Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Glucose Laboratory Values From Baseline to Week 52|"The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.
A subject was considered to have a treatment emergent, clinically significant Glucose value if during the course of the study, they had at least one clinically significant Glucose result that was not present at baseline. Subjects had Glucose labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52."|At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52|"Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.
Data may also be missing due to the subject's refusal to complete an assessment or examiner error."||participants|||Number
705779|NCT00112385|Primary|Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Aldolase Laboratory Values From Baseline to Week 52|"The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.
A subject was considered to have a treatment emergent, clinically significant Aldolase value if during the course of the study, they had at least one clinically significant Aldolase result that was not present at baseline. Subjects had Aldolase labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52."|Screening, Baseline (Week0), Week 4, 8,12, 16, 20, 24, 32, 40, and 52|"Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.
Data may also be missing due to the subject's refusal to complete an assessment or examiner error."||participants|||Number
705780|NCT00112385|Primary|Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Gamma-glutamyl Transpeptidase (GGT) Laboratory Values From Baseline to Week 52|"The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.
A subject was considered to have a treatment emergent, clinically significant GGT value if during the course of the study, they had at least one clinically significant GGT result that was not present at baseline. Subjects had GGT labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52."|Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52|"Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.
Data may also be missing due to the subject's refusal to complete an assessment or examiner error."||participants|||Number
705781|NCT00112385|Primary|Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Alanine Aminotransferase (ALT) Laboratory Values From Baseline to Week 52|"The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant ALT value if during the course of the study, they had at least one clinically significant ALT result that was not present at baseline.
Subjects had ALT labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52."|At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52|"Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.
Data may also be missing due to the subject's refusal to complete an assessment or examiner error."||participants|||Number
705782|NCT00112385|Primary|Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Creatine Kinase (CK) Laboratory Values From Baseline to Week 52|"The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.
A subject was considered to have a treatment emergent, clinically significant creatine kinase (CK) value if during the course of the study, they had at least one clinically significant CK result that was not present at baseline. Subjects had CK labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52."|At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52|"Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.
Data may also be missing due to the subject's refusal to complete an assessment or examiner error."||participants|||Number
705801|NCT00112385|Primary|Tolerability|The reported tolerability measure was defined as the number of participants that completed the entire 52 week study on their originally assigned treatment.|At any point between Baseline (week 0) and the end of the study (Week 52)|||Participants|||Number
705919|NCT00113087|Secondary|Neurodevelopmental Status (PDI): the Bayley Scales of Infant Development,Psychomotor Development Index Z-score|"Neurodevelopmental status (PDI):
the Bayley Scales of Infant Development: Psychomotor Development index z-score ."|at 14 months of age|ITT, no imputation||standard deviation||Standard Deviation|Mean
705783|NCT00112385|Primary|Average Change in Body Weight in Kilograms (kg) Comparing Baseline to Week 52.|"The subject's body weight was measured in kilograms(kg). The average value was calculated for each treatment group for the Baseline and Week 52 visits. The average change was determined by subtracting the average value at the Baseline Visit (Week 0) results from the Week 52 results (Week 52- Baseline (Week 0)).
This measure was also collected as part of the study protocol at the Screening visit and Week 4, 8, 12, 16, 20, 24, 32 and 40."|At Baseline (Week0) and Week 52|Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.||Kilograms||Standard Deviation|Mean
705784|NCT00112385|Primary|Average Change in Pulse Comparing Baseline to Week 52|"The subject's pulse was measured in beats per minute (BPM). The average value was calculated per treatment group for the Baseline and Week 52 visit. The average change was determined by subtracting the average value Baseline Visit (Week 0) results from the Week 52 results (Week 52- Baseline (Week 0)).
This measure was also collected as part of the study protocol at the Screening visit and Week 4, 8, 12, 16, 20, 24, 32 and 40."|At Baseline (Week0) and Week 52|Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.||beats per minute||Standard Deviation|Mean
705785|NCT00112385|Primary|Average Change in Diastolic Blood Pressure Comparing Baseline to Week 52.|"The subject's diastolic blood pressure was measured in millimeters of mercury (mm Hg). The average value was calculated for the Baseline and Week 52 visit based on treatment group. The average change was determined by subtracting the average value Baseline Visit (Week 0) results from the Week 52 results (Week 52- Baseline (Week 0)).
This measure was also collected as part of the study protocol at the Screening visit and Week 4,8,12,16,20,24,32 and 40."|At Baseline (Week0) and Week 52|Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.||mmHg||Standard Deviation|Mean
705786|NCT00112385|Primary|Average Change in Systolic Blood Pressure From Baseline to Week 52|"The subject's systolic blood pressure was measured in millimeters of mercury (mmHg). The average value was calculated per treatment group for the Baseline and Week 52 visit based on treatment group. The average change was determined by subtracting the average value Baseline Visit (Week 0) results from the Week 52 results (Week 52- Baseline (Week 0)).
This measure was also collected as part of the study protocol at the Screening visit and Week 4,8,12,16,20,24,32 and 40."|At Baseline (Week0) and Week 52|Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.||mmHg||Standard Deviation|Mean
705787|NCT00112385|Primary|Average Change in Respiration Rate From Baseline to Week 52|"The subject's respiration rate was measured as number of breaths per minute. The average change was determined by subtracting the Baseline Visit (Week 0) results from the Week 52 results (Week 52- Baseline (Week 0)).
This measure was also collected as part of the study protocol at the Screening visit and Week 4,8,12,16,20,24,32 and 40."|At Baseline (Week0) and Week 52|"Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.
In addition, data may be missing due to the subject's refusal to complete an assessment or examiner error."||breaths per minute||Standard Deviation|Mean
705788|NCT00112385|Primary|Average Change in Oral Temperature From Baseline to Week 52|"The subject's oral temperature was measured in degrees Celsius. The average change was determined by subtracting the Baseline Visit (Week 0) results from the Week 52 results (Week 52- Baseline (Week 0)).
This measure was also collected as part of the study protocol at the Screening visit and Week 4,8,12,16,20,24,32 and 40."|At Baseline (Week 0) and Week 52|"Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.
In addition, data may be missing due to the subject's refusal to complete an assessment or examiner error."||degrees Celsius||Standard Deviation|Mean
705789|NCT00112385|Other Pre-specified|Average Change in Percent Predicted Diffusion Capacity (DLCO)From the Screening Visit to Week 52|"Average change in percent predicted Diffusion Capacity (DLCO)from the Screening Visit to Week 52 was calculate. The average change was determined by subtracting the Screening test results from the Week 52 results (Week 52- Screening Visit). The Screening visit occurred within 8 weeks prior to the Baseline visit.
This assessment was also completed during the Week 24 visit."|Screening visit and Week 52|"Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.
In addition, data may be missing due to the subject's refusal to complete an assessment or examiner error."||Percent predicted||Standard Deviation|Mean
705790|NCT00112385|Other Pre-specified|Average Change in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) From the Screening Visit to Week 52|"The average change in percent predicted Forced Expiratory Volume in 1 second (FEV1) from Screening to Week 52 was calculated. The average change was determined by subtracting the Screening Visit results from the Week 52 results (Week 52- Screening visit). The Screening visit occurred within 8 weeks prior to the Baseline visit.
This assessment was also completed during the Week 24 visit."|Screening Visit and Week 52|"Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.
In addition, data may be missing due to the subject's refusal to complete an assessment or examiner error."||Percent predicted||Standard Deviation|Mean
705799|NCT00112385|Other Pre-specified|Average Change in Time (Seconds) to Walk 30 Feet Comparing Performance at Baseline to Week 52|"Average change in time to walk 30 feet comparing Baseline performance to Week 52.The average change was determined by subtracting the Baseline test results from the Week 52 results (Week 52- Baseline).
This measure was also collected as part of the study protocol at Week 4, 8, 12, 16, 20, 24, 32 and 40."|At Baseline (Week0) and Week 52|Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.||Seconds||Standard Deviation|Mean
705791|NCT00112385|Other Pre-specified|Forced Vital Capacity (FVC) Average Change in Percent Predicted From Screening to Week 52.|"The average change in percent predicted Forced Vital Capacity (FVC) from the Screening Visit to Week 52 was calculated. The average change was determined by subtracting the Screening Visit results from the Week 52 results (Week 52- Screening Visit). The Screening visit occurred within 8 weeks prior to the Baseline visit.
This assessment was also completed at the Week 24 visit."|Screening Visit and Week 52.|"Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.
In addition, data may be missing due to the subject's refusal to complete an assessment or examiner error."||Percent predicted||Standard Deviation|Mean
705792|NCT00112385|Other Pre-specified|Change in Health Assessment Questionnaire (HAQ) Score From Baseline to Week 52|"The Health Assessment Questionnaire (HAQ)was completed by subjects to assess the affects of their illness on the ability to function in daily life. The HAQ consists of 8 sections. Scoring within each section is from 0 (without any difficulty) to 3 (unable to do).The 8 scores of the 8 sections are summed and divided by 8. A higher score indicates more impairment.
The average change was determined by subtracting the Baseline test results from the Week 52 results (Week 52- Baseline).
This measure was also collected as part of the study protocol at Week 12, 24, 32 and 40."|At Baseline (Week0) and Week 52|Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.||Units on a scale||Standard Deviation|Mean
705793|NCT00112385|Other Pre-specified|Change in Pruritis Rating From Baseline to Week 52|"This is the average change in pruritis score from Baseline to Week 52. The assessment used a Visual Analog Scale to rate the subject's perceived level of pruritis (itchiness). A score of 0 cm indicated Not itchy at all. A score of 10.0 cm indicated Extremely itchy.
This assessment was also completed at Week 4, 8, 12, 16, 20, 24, 32 and 40."|At Baseline (Week0), and Week 52|Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.||cm||Standard Deviation|Mean
705794|NCT00112385|Other Pre-specified|Average Change in Cutaneous Disease Activity and Severity Index (CDASI) Score From Week 52 to Baseline|"Average change in Cutaneous Disease Activity and Severity Index (CDASI) score from Baseline to Week 52. The assessment graded the severity of the subject's rash. The rash was rated using a a 4-point scale with a score of 0 indicating no rash. The score was added together using all 13 anatomical locations included on the assessment. The average change was determined by subtracting the Baseline test results from the Week 52 results (Week 52- Baseline).
This measure was also collected as part of the study protocol at Week 4, 8, 12, 16, 20, 24, 32 and 40."|At Baseline (Week0) and Week 52|Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.||Units on a scale||Standard Deviation|Mean
705795|NCT00112385|Other Pre-specified|Average Change in Patient Global Activity Assessment Score From Baseline to Week 52|"Average change in Patient Global Activity Assessment score from Baseline to Week 52. The assessment used a Visual Analog Scale to rate the subject's perceived global (overall) disease activity. A score of 0 cm indicated no evidence of disease activity. A score of 10.0 cm indicated extremely active disease.
This measure was also collected as part of the study protocol at Week 12, 24, 32 and 40."|At Baseline (Week0) and Week 52|Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.||cm||Standard Deviation|Mean
705796|NCT00112385|Other Pre-specified|Average Change in Physician Global Activity Assessment From Baseline to Week 52|"Average change in Physician Global Activity Assessment score from Baseline to Week 52. The assessment used a Visual Analog Scale to rate the subject's global (overall) disease activity. A score of 0 cm indicated no evidence of disease activity. A score of 10.0 cm indicated extremely active disease. The average change was determined by subtracting the Baseline test results from the Week 52 results (Week 52- Baseline).
This measure was also collected as part of the study protocol at Week 4, 8, 12, 16, 20, 24, 32 and 40."|At Baseline (Week0) and Week 52|Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.||cm||Standard Deviation|Mean
705797|NCT00112385|Other Pre-specified|Average Change in Z-score for Dual-emission X-ray Absorptiometry (DEXA) of the Lumbar Spine From the Screening Visit to Week 52|The average change in z-score for Dual-emission X-ray absorptiometry (DEXA) of the lumbar spine was calculated comparing the results from the Screening visit to Week 52. The average change was determined by subtracting the Screening Visit (Week <8)test results from the Week 52 results (Week 52- screening Visit). The Screening visit occurred within 8 weeks of the Baseline visit.|Screening visit and Week 52.|Data for all subjects enrolled in the trial are not available for this assessment. One subject left the study early and one subject was lost to follow-up before the Week 52 visit. In addition, data may be missing due to the subject's refusal to complete an assessment or examiner error.||Z-Score||Standard Deviation|Mean
705798|NCT00112385|Other Pre-specified|Average Change in Z-score for Dual-emission X-ray Absorptiometry (DEXA) of the Femur From the Screening Visit to Week 52|"The average change in z-score for Dual-emission X-ray absorptiometry (DEXA) of the femur from the Screening visit to the Week 52 visit was calculated. The average change was determined by subtracting the Screening Visit test results from the Week 52 results (Week 52- Screening visit).
The Screening visit was conducted within 8 weeks of the Baseline visit."|Screening and Week 52|"Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.
In addition, data may be missing due to the subject's refusal to complete an assessment or examiner error."||Z-score||Standard Deviation|Mean
705835|NCT00112437|Secondary|Percentage Change in Total Body Bone Mineral Density at 12 Months|Percentage change in total body Bone Mineral Density (relative to baseline) at 12 Months|Baseline and 12 Months|This analysis was performed at Month 12 using Full-Analysis-Set Population with Last Observation Carried Forward.||Percentage change||95% Confidence Interval|Least Squares Mean
705802|NCT00112385|Other Pre-specified|Change in the Average Manual Muscle Testing (MMT) Score From Baseline to Week 52|"The Manual Muscle Test (MMT) assesses 26 muscle groups. The muscle strength of each muscle group is graded. The score for each muscle group ranges from 0 (No contraction palpable) to 5 (normal strength). The minimum total MMT score is a 0. The maximum total MMT score is a 130.
The average change in the average Manual Muscle Testing (MMT)from Baseline to Week 52 was calculated. The average score is composed of 26 muscle groups that were tested. The average change was determined by subtracting the Baseline test results from the Week 52 results (Week 52- Baseline)."|At Baseline (Week 0) and Week 52|Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.||Units on a scale||Standard Deviation|Mean
705803|NCT00112385|Secondary|Average Prednisone Dosage After Week 24|We calculated the average dosage of prednisone from the week 24 visit until the end of the study (week 52).|from week 24 to 52|||mg||Inter-Quartile Range|Median
705804|NCT00112385|Other Pre-specified|The Number of Participants Who Were Classified as Treatment Failures|Treatment failures were determined based on criteria from the study protocol using objective and subjective ratings from the study physician. If the study physician felt that the rate of prednisone taper needed to be reduced, the prednisone dose needed to be increased or restarted, or a second-line agent added, the patient will be considered to be a treatment failure.|At any point during the 52 week study|||participants|||Number
705805|NCT00112385|Primary|Occurrence of at Least One Adverse Event|"Adverse events (AEs) were assessed using the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE). The grade of mild, moderate or severe matches with the descriptions from the CTCAE dictionary.
In general, a Mild AE is asymptomatic; clinical or diagnostic observations only; intervention not indicated.
A Moderate AE is minimal, local or noninvasive intervention indicated; limiting activities of daily living.
A Severe AE is medically significant but not immediately life-threatening; hospitalization or prolonged hospitalization indicated; disabling;"|at each visit during the 12 month study|Intention- to -Treat (ITT)||participants|||Number
705806|NCT00112437|Secondary|Geometric Mean Percentage Change From Baseline, in Biochemical Marker of Bone Turnover (Serum Cross-Linked Carboxyterminal Telopeptides of Type I Collagen [1-CTP]) at 36 Months|Geometric mean Percentage change from baseline, in Biochemical Marker of bone turnover (serum Cross-Linked Carboxyterminal Telopeptides of Type I Collagen [1-CTP]) at 36 Months|Baseline and 36 months|This analysis was geometric mean percent change from baseline (which is a back-transformation of a log-transformed fraction from baseline) at Month 36 using a Per-Protocol approach where patients with important protocol deviations and major protocol violators were excluded from the analyses. The per-protocol approach did not estimate missing data.||Geometric Mean Percent Change||95% Confidence Interval|Least Squares Mean
705807|NCT00112437|Secondary|Geometric Mean Percentage Change From Baseline, in Biochemical Marker of Bone Turnover (Serum Bone Tartrate-resistant Acid Phosphatase Isoform 5b) [TRAP 5-b]) at 36 Months|Geometric Mean Percentage change from baseline, in Biochemical Marker of Bone turnover (serum Bone tartrate-resistant acid phosphatase isoform 5b [TRAP 5-b]) at 36 Months|Baseline and 36 months|This analysis was geometric mean percent change from baseline (which is a back-transformation of a log-transformed fraction from baseline) at Month 36 using a Per-Protocol approach where patients with important protocol deviations and major protocol violators were excluded from the analyses. The per-protocol approach did not estimate missing data.||Geometric Mean Percent Change||95% Confidence Interval|Least Squares Mean
705808|NCT00112437|Secondary|Percentage Change in Biochemical Marker of Bone Turnover (Serum N-terminal Propeptide of Type 1 Collagen [s-P1NP]) at 36 Months|Geometric Mean Percentage change from baseline, in Biochemical Marker of Bone turnover (serum N-terminal propeptide of Type 1 collagen [s-P1NP]) at 36 Months|Baseline and 36 months|This analysis was geometric mean percent change from baseline (which is a back-transformation of a log-transformed fraction from baseline) at Month 36 using a Per-Protocol approach where patients with important protocol deviations and major protocol violators were excluded from the analyses. The per-protocol approach did not estimate missing data.||Geometric Mean Percent Change||95% Confidence Interval|Least Squares Mean
705809|NCT00112437|Secondary|Geometric Mean Percentage Change From Baseline, in Biochemical Marker of Bone Turnover (Serum Bone-specific Alkaline Phosphatase [s-BSAP]) at 36 Months|Geometric Mean Percentage change from baseline, in Biochemical Marker of Bone turnover (serum bone-specific alkaline phosphatase [s-BSAP]) at 36 Months|Baseline and 36 months|This analysis was geometric mean percent change from baseline (which is a back-transformation of a log-transformed fraction from baseline) at Month 36 using a Per-Protocol approach where patients with important protocol deviations and major protocol violators were excluded from the analyses. The per-protocol approach did not estimate missing data.||Geometric Mean Percent Change||95% Confidence Interval|Least Squares Mean
705810|NCT00112437|Secondary|Geometric Mean Percentage Change From Baseline, in Biochemical Marker of Bone Turnover (Urinary Total Deoxypyridinolines [u-DPyr]) at 36 Months|Geometric Mean Percentage change from baseline, in Biochemical Marker of Bone turnover (urinary total deoxypyridinolines [u-DPyr]) at 36 Months|Baseline and 36 months|This analysis was geometric mean percent change from baseline (which is a back-transformation of a log-transformed fraction from baseline) at Month 36 using a Per-Protocol approach where patients with important protocol deviations and major protocol violators were excluded from the analyses. The per-protocol approach did not estimate missing data.||Geometric Mean Percent Change||95% Confidence Interval|Least Squares Mean
705811|NCT00112437|Secondary|Geometric Mean Percentage Change From Baseline, in Biochemical Marker of Bone Turnover (Serum C-telopeptides of Type 1 Collagen [s-CTx]) at 36 Months|Geometric Mean Percentage change from baseline, in Biochemical Marker of Bone turnover (serum C-telopeptides of Type 1 collagen [s-CTx]) at 36 Months|Baseline and 36 months|This analysis was geometric mean percent change from baseline (which is a back-transformation of a log-transformed fraction from baseline) at Month 36 using a Per-Protocol approach where patients with important protocol deviations and major protocol violators were excluded from the analyses. The per-protocol approach did not estimate missing data.||Geometric Mean Percent Change||95% Confidence Interval|Least Squares Mean
705836|NCT00112437|Secondary|Percentage Change in Trochanter Bone Mineral Density at 12 Months|Percentage change in Trochanter Bone Mineral Density (relative to baseline) at 12 Months|Baseline and 12 Months|This analysis was performed at Month 12 using Full-Analysis-Set approach with Last Observation Carried Forward.||Percentage change||95% Confidence Interval|Least Squares Mean
705812|NCT00112437|Secondary|Geometric Mean Percentage Change From Baseline, in Biochemical Marker of Bone Turnover (Urinary N-telopeptides of Type I Collagen [u-NTx]) at 36 Months|Geometric Mean Percentage change from baseline, in Biochemical Marker of Bone turnover (urinary N-telopeptides of Type I collagen [u-NTx]) at 36 Months|Baseline and 36 months|This analysis was geometric mean percent change from baseline (which is a back-transformation of a log-transformed fraction from baseline) at Month 36 using a Per-Protocol approach where patients with important protocol deviations and major protocol violators were excluded from the analyses. The per-protocol approach did not estimate missing data.||Geometric Mean Percent Change||95% Confidence Interval|Least Squares Mean
705813|NCT00112437|Secondary|Percentage Change From Baseline in Distal Forearm Bone Mineral Density at 36 Months|Percentage change in Distal Forearm Bone Mineral Density (relative to baseline) at 36 Months|Baseline and 36 months|This analysis was performed at Month 36 using the Per-protocol approach which includes patients who took at least one dose of extension study medication and had the necessary follow-up information. Missing values were not imputed. No data were carried forward from month 30 to 36.||Percent Change||95% Confidence Interval|Least Squares Mean
705814|NCT00112437|Secondary|Percentage Change From Baseline in Total Body Bone Mineral Density at 36 Months|Percentage change in Total Body Bone Mineral Density (relative to baseline) at 36 Months|Baseline and 36 months|This analysis was performed at Month 36 using the Per-protocol approach which includes patients who took at least one dose of extension study medication and had the necessary follow-up information. Missing values were not imputed. No data were carried forward from month 30 to 36.||Percent Change||95% Confidence Interval|Least Squares Mean
705815|NCT00112437|Secondary|Percentage Change From Baseline in Trochanter Bone Mineral Density at 36 Months|Percentage change in Trochanter Bone Mineral Density (relative to baseline) at 36 Months|Baseline and 36 months|This analysis was performed at Month 36 using the Per-protocol approach which includes patients who took at least one dose of extension study medication and had the necessary follow-up information. Missing values were not imputed. No data were carried forward from month 30 to 36.||Percent Change||95% Confidence Interval|Least Squares Mean
705816|NCT00112437|Secondary|Percentage Change From Baseline in Femoral Neck Bone Mineral Density at 36 Months|Percentage change in Femoral Neck Bone Mineral Density (relative to baseline) at 36 Months|Baseline and 36 months|This analysis was performed at Month 36 using the Per-protocol approach which includes patients who took at least one dose of extension study medication and had the necessary follow-up information. Missing values were not imputed. No data were carried forward from month 30 to 36.||Percent Change||95% Confidence Interval|Least Squares Mean
705817|NCT00112437|Secondary|Percentage Change From Baseline in Total Hip Bone Mineral Density at 36 Months|Percentage change in Total Hip Bone Mineral Density (relative to baseline) at 36 Months|Baseline and 36 months|This analysis was performed at Month 36 using the Per-protocol approach which includes patients who took at least one dose of extension study medication and had the necessary follow-up information. Missing values were not imputed. No data were carried forward from month 30 to 36.||Percent Change||95% Confidence Interval|Least Squares Mean
705818|NCT00112437|Primary|Percentage Change From Baseline in Lumbar Spine Bone Mineral Density at 36 Months|Percentage change in lumbar spine Bone Mineral Density (relative to baseline) at 36 Months.|Baseline and 36 months|This analysis was performed at Month 36 using the Per-protocol approach which includes patients who took at least one dose of extension study medication and had the necessary follow-up information. Missing values were not imputed. No data were carried forward from month 30 to 36.||Percent Change||95% Confidence Interval|Least Squares Mean
705819|NCT00112437|Secondary|Percentage Change in Biochemical Marker of Bone Turnover (Serum N-terminal Propeptide of Type 1 Collagen (s-P1NP)) at 24 Months|Back-transformation (geometric mean) of the Least Squares Mean of the log-values Percentage change from baseline, in Biochemical Marker of Bone turnover (serum N-terminal propeptide of Type 1 collagen (s-P1NP)) (relative to baseline) at 24 Months|Baseline and 24 months|Analysis used geometric mean percent change from baseline (back-transformation of a log-transformed fraction from baseline) at Month 24 using a Per-Protocol approach where patients with important protocol deviations and major protocol violators were excluded from the analyses. The per-protocol approach did not estimate missing data.||Geometric LS Mean percent change||95% Confidence Interval|Least Squares Mean
705820|NCT00112437|Secondary|Percentage Change in Biochemical Marker of Bone Turnover (Serum Bone-specific Alkaline Phosphatase (s-BSAP)) at 24 Months|Back-transformation (geometric mean) of the Least Squares Mean of the log-values Percentage change from baseline, in Biochemical Marker of Bone turnover (serum bone-specific alkaline phosphatase (s-BSAP)) (relative to baseline) at 24 Months|Baseline and 24 months|Analysis used geometric mean percent change from baseline (back-transformation of a log-transformed fraction from baseline) at Month 24 using a Per-Protocol approach where patients with important protocol deviations and major protocol violators were excluded from the analyses. The per-protocol approach did not estimate missing data.||Geometric LS Mean percent change||95% Confidence Interval|Least Squares Mean
705821|NCT00112437|Secondary|Percentage Change in Biochemical Marker of Bone Turnover (Urinary Total Deoxypyridinolines (u-DPyr)) at 24 Months|Back-transformation (geometric mean) of the Least Squares Mean of the log-values Percentage change from baseline, in Biochemical Marker of Bone turnover (urinary total deoxypyridinolines (u-DPyr)) (relative to baseline) at 24 Months|Baseline and 24 months|Analysis used geometric mean percent change from baseline (back-transformation of a log-transformed fraction from baseline) at Month 24 using a Per-Protocol approach where patients with important protocol deviations and major protocol violators were excluded from the analyses. The per-protocol approach did not estimate missing data.||Geometric LS Mean percent change||95% Confidence Interval|Least Squares Mean
705822|NCT00112437|Secondary|Percentage Change in Biochemical Marker of Bone Turnover (Serum C-telopeptides of Type 1 Collagen (s-CTx)) at 24 Months|Back-transformation (geometric mean) of the Least Squares Mean of the log-values Percentage change from baseline, in Biochemical Marker of Bone turnover (serum C-telopeptides of Type 1 collagen (s-CTx)) (relative to baseline) at 24 Months|Baseline and 24 months|Analysis used geometric mean percent change from baseline (back-transformation of a log-transformed fraction from baseline) at Month 24 using a Per-Protocol approach where patients with important protocol deviations and major protocol violators were excluded from the analyses. The per-protocol approach did not estimate missing data.||Geometric LS Mean percent change||95% Confidence Interval|Least Squares Mean
705920|NCT00113087|Secondary|B-type Natriuretic Peptide Level|B-type natriuretic peptide (BNP) level.|at the time of the 14 month visit|ITT, no imputation||pg/ml||Inter-Quartile Range|Median
705823|NCT00112437|Secondary|Percentage Change in Biochemical Marker of Bone Turnover (Urinary N-telopeptides of Type I Collagen (u-NTx)) at 24 Months|Back-transformation (geometric mean) of the Least Squares Mean of the log-values Percentage change from baseline, in Biochemical Marker of Bone turnover (urinary N-telopeptides of Type I collagen (u- NTx)) (relative to baseline) at 24 Months|Baseline and 24 months|Analysis used a geometric mean percent change from baseline (back-transformation of a log-transformed fraction from baseline) at Month 24 using a Per-Protocol approach where patients with important protocol deviations and major protocol violators were excluded from the analyses. The per-protocol approach did not estimate missing data.||Geometric LS Mean percent change||95% Confidence Interval|Least Squares Mean
705824|NCT00112437|Secondary|Percentage Change in Distal Forearm Bone Mineral Density at 24 Months|Percentage change in Distal Forearm Bone Mineral Density (relative to baseline) at 24 Months|Baseline and 24 months|This analysis was performed at Month 24 using Full-Analysis-Set Population with Last Observation Carried Forward (from extension data). No data was carried forward from the core to the extension period.||Percentage change||95% Confidence Interval|Least Squares Mean
705825|NCT00112437|Secondary|Percentage Change in Total Body Bone Mineral Density at 24 Months|Percentage change in total body Bone Mineral Density (relative to baseline) at 24 Months|Baseline and 24 months|This analysis was performed at Month 24 using Full-Analysis-Set Population with Last Observation Carried Forward. No data was carried forward from the core to the extension period.||Percentage change||95% Confidence Interval|Least Squares Mean
705826|NCT00112437|Secondary|Percentage Change in Tronchanter Bone Mineral Density at 24 Months|Percentage change in trochanter Bone Mineral Density (relative to baseline) at 24 Months|Baseline and 24 months|This analysis was performed at Month 24 using Full-Analysis-Set Population with Last Observation Carried Forward (from extension data). No data was carried forward from the core to the extension period.||Percent Change||95% Confidence Interval|Least Squares Mean
705827|NCT00112437|Secondary|Percentage Change in Femoral Neck Bone Mineral Density at 24 Months|Percentage change in femoral neck Bone Mineral Density (relative to baseline) at 24 Months|Baseline and 24 months|This analysis was performed at Month 24 using Full-Analysis-Set Population with Last Observation Carried Forward (from extension data). No data was carried forward from the core to the extension period.||Percentage change||95% Confidence Interval|Least Squares Mean
705828|NCT00112437|Secondary|Percentage Change in Total Hip Bone Mineral Density at 24 Months|Percentage change in total hip Bone Mineral Density (relative to baseline) at 24 Months|Baseline and 24 months|This analysis was performed at Month 24 using Full-Analysis-Set Population with Last Observation Carried Forward (from extension data). No data was carried forward from the core to the extension period.||Percentage change||95% Confidence Interval|Least Squares Mean
705829|NCT00112437|Secondary|Percentage Change in Biochemical Marker of Bone Turnover (Serum N-terminal Propeptide of Type 1 Collagen (s-P1NP)) at 12 Months|Back-transformation (geometric mean) of the Least Squares Mean of the log-values Percentage change in Biochemical Marker of Bone turnover (serum N-terminal propeptide of Type 1 collagen (s-P1NP) (relative to baseline) at 12 Months|Baseline and 12 months|This analysis was a geometric mean percent change from baseline (back-transformation of a log-transformed fraction from baseline) at Month 12 using a Per-Protocol approach, where patients with important protocol deviations and major protocol violators were excluded from the analyses. The per-protocol approach did not estimate missing data.||Geometric LS Mean percent change||95% Confidence Interval|Least Squares Mean
705830|NCT00112437|Secondary|Percentage Change in Biochemical Marker of Bone Turnover (Serum Bone-specific Alkaline Phosphatase (s-BSAP)) at 12 Months|Back-transformation (geometric mean) of the Least Squares Mean of the log-values Percentage change from baseline, in Biochemical Marker of Bone turnover (serum bone-specific alkaline phosphatase (s-BSAP)), at 12 Months|Baseline and 12 months|This analysis was a geometric mean percent change from baseline (back-transformation of a log-transformed fraction from baseline) at Month 12 using a Per-Protocol approach, where patients with important protocol deviations and major protocol violators were excluded from the analyses. The per-protocol approach did not estimate missing data.||Geometric LS Mean percent change||95% Confidence Interval|Least Squares Mean
705831|NCT00112437|Secondary|Percentage Change in Biochemical Marker of Bone Turnover (Urinary Total Deoxypyridinolines (u-DPyr)) at 12 Months|Back-transformation (geometric mean) of the Least Squares Mean of the log-values Percentage change in Biochemical Marker of Bone turnover (urinary total deoxypyridinolines (u-DPyr)) (relative to baseline) at 12 Months|Baseline and 12 months|This analysis was a geometric mean percent change from baseline (back-transformation of a log-transformed fraction from baseline) at Month 12 using a Per-Protocol approach, where patients with important protocol deviations and major protocol violators were excluded from the analyses The per-protocol approach did not estimate missing data.||Geometric LS Mean percent change||95% Confidence Interval|Least Squares Mean
705832|NCT00112437|Secondary|Percentage Change in Biochemical Marker of Bone Turnover (Serum C-telopeptides of Type 1 Collagen (s-CTx)) at 12 Months|Back-transformation (geometric mean) of the Least Squares (LS) Mean of the log-values Percentage change from baseline in Biochemical Marker of Bone turnover (serum C-telopeptides of Type 1 collagen (s-CTx)) at 12 Months.|Baseline and 12 Months|This analysis was a geometric mean percent change from baseline (which is a back-transformation of a log-transformed fraction from baseline) at Month 12 using a Per-Protocol approach, where patients with important protocol deviations and major protocol violators were excluded from the analyses The per-protocol approach did not estimate missing data||Geometric LS Mean percent change||95% Confidence Interval|Least Squares Mean
705833|NCT00112437|Secondary|Percentage Change in Biochemical Marker of Bone Turnover (Urinary N-telopeptides of Type I Collagen (u-NTx)) at 12 Months|Back-transformation (geometric mean) of the Least Squares (LS) Mean of the log-values Percentage change from baseline, in Biochemical Marker of Bone turnover (urinary N-telopeptides of Type I collagen (u-NTx)) at 12 Months|Baseline and 12 Months|This analysis was geometric mean percent change from baseline (which is a back-transformation of a log-transformed fraction from baseline) at Month 12 using a Per-Protocol approach where patients with important protocol deviations and major protocol violators were excluded from the analyses. The per-protocol approach did not estimate missing data.||Geometric LS Mean percent change||95% Confidence Interval|Least Squares Mean
705834|NCT00112437|Secondary|Percentage Change in Distal Forearm Bone Mineral Density at 12 Months|Percentage change in Distal Forearm Bone Mineral Density (relative to baseline) at 12 Months|Baseline and 12 Months|This analysis was performed at Month 12 using Full-Analysis-Set Population with Last Observation Carried Forward||Percentage change||95% Confidence Interval|Least Squares Mean
705839|NCT00112437|Primary|Percentage Change From Baseline in Lumbar Spine Bone Mineral Density at 24 Months|Percentage change in lumbar spine Bone Mineral Density (relative to baseline) at 24 Months.|Baseline and 24 months|Analysis on Lumbar Spine Bone Mineral Density (g/cm2) at Month 24 used the Full-Analysis-Set Population with Last Observation Carried Forward from Month 18 to 24. No data were carried forward from the core to the extension period. Only patients who took at least one dose of extension medication were included. 17 patients were excluded from FAS.||Percent Change||95% Confidence Interval|Least Squares Mean
705840|NCT00112437|Primary|Percentage Change From Baseline in Lumbar Spine Bone Mineral Density at 12 Months|Percentage change in lumbar spine Bone Mineral Density (relative to baseline) at 12 Months.|Baseline and 12 months|Analysis at Month 12 used Full-Analysis-Set Population of patients who took at least one dose of study medication and had necessary follow-up information, in their randomization treatment group, with last observation data carried forward. Seven patients had a baseline value, but no value at Month 12 for lumbar spine Bone Mineral Density.||Percent Change||95% Confidence Interval|Least Squares Mean
705841|NCT00112463|Secondary|Survival|Months from first treatment until death or the last date of contact|Max of 98 months|All treated participants||months||95% Confidence Interval|Median
705842|NCT00112463|Primary|Toxicity as Assessed Using the Expanded Common Toxicity Criteria Version 3|"The outcome reported here is the number (%) of participants who experienced grade 3 or greater toxicity while on study.
A summary of the individual toxicities can be found in the AE/SAE results."|During treatment (max of 16 months) and for 1 month following treatment|All treated participants||Participants|||Count of Participants
705843|NCT00112463|Primary|Time to Progression|Progressive disease is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameters (LD) of target lesions, taking as reference the smallest sum LD recorded since treatment started, or a measurable increase in a non-target lesion, or the appearance of new lesions. Time to progression is the number of months from first treatment until the date of progression.|Until disease progression - max of 48 months|All treated participants||months||95% Confidence Interval|Median
705844|NCT00112463|Primary|Objective Tumor Response (Complete and Partial)|Objective tumor response was evaluated using the criteria proposed by the Response Evaluation Criteria In Solid Tumors (RECIST) Committee (JNCI 92(3):205-216,2000). Changes in only the largest diameter (unidimensional measurement) of the target lesions are used. A sum of the longest diameter (LD) for all target lesions was calculated and reported as the baseline sum LD. The baseline sum LD was used as reference by which to characterize the objective tumor response. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum LD; Overall Response (OR) = CR + PR|While on treatment - max of 16 months|Participants who were evaluable for response||Participants|||Count of Participants
705845|NCT00112489|Primary|Response Evaluation Criteria in Solid Tumors Criteria (RECIST) 1.0 Best Response|"Primary outcome measured according to RECIST v1.0 Best Response:
Complete Response (CR) is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart Disease Progression is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.
Partial Response (PR) is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of nontarget lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required Stable Disease is any condition not meeting the above criteria. Indeterminate is defined as having no repeat tumor assessments following initiation of study therapy for reasons unrelated to symptoms or signs of disease."|Response was measured every other cycle (q 6 weeks) until disease progression is documented.|Total eligible and treated participants||participants|||Number
705846|NCT00112489|Primary|Nature and Degree of Toxicity|Number of patients who experienced grade 1 or higher serious adverse event (term or group) regardless of attribution using CTCAE v3.0|During study treatment and up to 30 days after stopping study treatment||||||
705847|NCT00112593|Secondary|Reconstitution of HIV-specific Immunity||Up to 1 year|||Participants|||Count of Participants
705848|NCT00112593|Secondary|Progression of HIV|Count of participants with HIV progression.|Within 1 year|||Participants|||Count of Participants
705849|NCT00112593|Secondary|Overall Survival|Kaplan-Meier estimate assessed at 1 year.|Up to 1 year|||survival probability||95% Confidence Interval|Number
705850|NCT00112593|Primary|Successful Induction of Mixed Hematopoietic Chimerism as Assessed by the Percentage of Peripheral Blood T Cells That Are of Donor Origin|Determined by a DNA-based assay that compares the profile of amplified fragment length polymorphisms (ampFLP) of the patient and donor.|Up to day 80|||Participants|||Count of Participants
705851|NCT00112593|Primary|Death From GVHD||Within the first 360 days|||Participants|||Count of Participants
705852|NCT00112593|Primary|Death From Regimen Toxicity or Opportunistic Infection||Within the first 100 days|||Participants|||Count of Participants
705853|NCT00112671|Secondary|Frequency and Severity of Adverse Events|Will be tabulated using counts and proportions detailing frequently occurring, serious and severe events of interest.|Up to 5 years||||||
705854|NCT00112671|Secondary|Progression-free Survival|Summary statistics, such as the mean, median, counts and proportion, will be used to summarize the patients. Survival estimates will be computed using the Kaplan-Meier method. Potential association between variables will be measured using Pearson correlation coefficients, chi-square tests, one- or two-sample t-tests or logistic regression analyses as appropriate. Non-parametric tests such as Spearman correlation coefficients, Fisher’s exact tests and Wilcoxon tests may be substituted if necessary. 95% confidence intervals will be constructed and selected results will be illustrated.|From start of treatment to progression or death, assessed up to 1 year||||||
705855|NCT00112671|Secondary|Time to Progression|Summary statistics, such as the mean, median, counts and proportion, will be used to summarize the patients. Potential association between variables will be measured using Pearson correlation coefficients, chi-square tests, one- or two-sample t-tests or logistic regression analyses as appropriate. Non-parametric tests such as Spearman correlation coefficients, Fisher’s exact tests and Wilcoxon tests may be substituted if necessary. 95% confidence intervals will be constructed and selected results will be illustrated using figures and plots.|Up to 5 years|||months||95% Confidence Interval|Median
705856|NCT00112671|Secondary|Rate and Duration of Stable Disease|Summary statistics, such as the mean, median, counts and proportion, will be used to summarize the patients. Potential association between variables will be measured using Pearson correlation coefficients, chi-square tests, one- or two-sample t-tests or logistic regression analyses as appropriate. Non-parametric tests such as Spearman correlation coefficients, Fisher’s exact tests and Wilcoxon tests may be substituted if necessary. 95% confidence intervals will be constructed and selected results will be illustrated using figures and plots.|From the start of the treatment until the criteria for progression are met, up to 5 years|Stable disease for more than 3 months||participants|||Number
705857|NCT00112671|Primary|Antitumor Activity of BAY 43-9006 Using Objective Tumor Response Rate Defined as Partial or Complete Response by the RECIST Criteria|Summary statistics, such as the mean, median, counts and proportion, will be used to summarize the patients. Potential association between variables will be measured using Pearson correlation coefficients, chi-square tests, one- or two-sample t-tests or logistic regression analyses as appropriate. Non-parametric tests such as Spearman correlation coefficients, Fisher’s exact tests and Wilcoxon tests may be substituted if necessary. 95% confidence intervals will be constructed and selected results will be illustrated using figures and plots.|Up to 5 years|||participants|||Number
705858|NCT00112723|Secondary|Pharmacokinetics (Cmax) of Flavopiridol|Whole blood samples were collected for pharmacokinetics analysis during the first (Day 1) and fourth (Day 22) treatments during cycle 1. Samples were collected on both occasions prior to dosing and at 0.5, 1, 3, 4.5, 6, 8 and 24 hour after the start of the bolus infusion.|0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Days 1 and 22 of Cycle 1|||μM||Standard Deviation|Mean
705859|NCT00112723|Secondary|Pharmacodynamic Effects of Flavopiridol on Normal Peripheral Blood Mononuclear Cells (PBMCs).|The correlation of the pharmacodynamic effects of flavopiridol on normal peripheral blood mononuclear cells (PBMCs)|Day 1|Data not available due to studies were not conducted by collaborating laboratory Investigator|||||
705860|NCT00112723|Secondary|Induced Response in Patients Independent of p53 Mutational Status|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 2 years|Data not available due to studies were not conducted by collaborating laboratory Investigator|||||
705861|NCT00112723|Secondary|Number of Patients Reporting Acute Infusion Toxicity (e.g., Fever, Hypotension, Tumor Pain, and Dyspnea)||Up to 30 days after completion of study treatment|||patients|||Number
705862|NCT00112723|Secondary|Pharmacokinetics (Area Under the Curve; AUC) of Flavopiridol|Whole blood samples were collected for pharmacokinetics analysis during the first (Day 1) and fourth (Day 22) treatments during cycle 1. Samples were collected on both occasions prior to dosing and at 0.5, 1, 3, 4.5, 6, 8 and 24 hour after the start of the bolus infusion.|0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Days 1 and 22 of Cycle 1|total of 71 PK (Pharmacokinetic) profiles comprising 484 plasma concentration were determined for 45 of 46 patients following treatment||hr×μM||Standard Deviation|Mean
705863|NCT00112723|Primary|Lymphoid/Plasma Cell Malignancies|Identify subsets, based on levels of response (PR and SD), of lymphoid / plasma cell malignancies that are suitable for larger phase II studies designed to further evaluate the efficacy and toxicity of flavopiridol.|Up to 2 years|Response indicated for Indolent B-cell NHL, Mantle cell NHL and T-cell NHL||patients|||Number
705864|NCT00112723|Primary|Qualitative and Quantitative Toxicities in Regard to Organ Specificity|The NCI Common Toxicity Criteria for Adverse Events (version 3.0) were used to define and grade toxicity for patients.|Up to 30 days after completion of study treatment|Grade 3 and 4 toxicities.||percentage of patients|||Number
705865|NCT00112723|Primary|Complete and Partial Response Rate (Phase II)|Patients were assessed for clinical response after two , four and six cycle with laboratory studies, physical exam, and CT scans. Response was evaluated using the modified NCI-sponsored Working Group Lymphoma Response Criteria.|Up to 2 years|Includes patients enrolled with Indolent B-cell NHL, Intermediate Grade B NHL, Mantle cell NHL and T/NK-cell NHL||patients|||Number
705866|NCT00112723|Primary|Maximum Tolerated Dose (MTD)|The maximum tolerated dose (MTD) is defined as that dose level beneath the dose at which 2 or more of 6 patients experience DLT.|28 days|||mg/m2|||Number
705867|NCT00112723|Primary|Disease-specific Dose-limiting Toxicity and Maximum Tolerated Dose of Flavopiridol Graded According to the CTCAE (Common Toxicity Criteria for Adverse Effects) Version 4.0 (Phase I)|Dose limiting toxicity (DLT) for an individual disease group is defined as 1) any grade 3-4 non-hematologic toxicity (except leukopenia or neutropenia) that does not resolve or decrease to grade 1-2 within 2 weeks, or 2) any grade 4 hematologic toxicity that causes more than a 1 week delay in administration of therapy.|28 days|||patients|||Number
705868|NCT00112736|Primary|Progression-free Survival at 6 Months (Phase II)|"Progression (PD): 25% increase in the sum of products of all measurable lesions over smallest sum observed, OR clear worsening or failure to return for evalution due to death or deteriorating condition (unless clearly unrelated to brain cancer).
Responses had to be present on 2 consecutive scans and were centrally reviewed."|Evaluated at baseline and every other cycle, till Month 6|Primary endpoint PFS6 date of registration; Sample size chosen to discriminate between 15% & 35% PFS6 rates for GBM patients. With accrual 32 GBM patients, trial would be considered successful if 8 achieved PFS6. This yields 0.92 power to detect a 35% PFS6 rate, with 0.90 probability of rejecting the treatment regimen if the PFS6 rate is only 15%.||participants|||Number
705869|NCT00112736|Primary|Pharmacokinetics (Phase I)|"Tersirolimus Cmax (ng/mL) for cycle 1 is presented in the outcome measure table below for the 3 dose levels
blood samples (5ml) was collected in EDTA containing tubes on days 1 and 2 of cycle 1
Collection time points: prior to dosing of both drugs, at end of temsirolimus infusion and at 1,2,4,6, and 24 hr after erlotinib administration"|Days 1, 2 of cycle 1, prior to dosing of both drugs, at end of temsirolimus infusion and at 1,2,4,6, and 24 hr after erlotinib administration|per protocol||ng/mL||Standard Deviation|Mean
705881|NCT00112866|Secondary|Changes in Endothelial Cell Apoptosis|Will be performed between the untreated matched control tumor tissue and the tissue obtained from the post-treatment tumors using either a Fisher’s Exact test or the Wilcoxon rank sum test depending on whether the assay provides a measurement or is yes/no.|Baseline and up to 4 years|Molecular analyses evaluating alterations planned, unfortunately, majority of tumor samples were too small to do both measures of drug and molecular analysis or sample was inadequate for both after removal of areas of necrosis and gliosis|||||
705870|NCT00112736|Primary|Efficacy - Response Phase 1|"pt must have at least 8 weeks of treatment to receive MRI scan, scans are every other cycle (every 2 months). Response measured by a bidimensionally measured leison and clearly defined margins by CT or MRI scan.
Complete Response (CR): complete disappearance of all measurable and evaluable disease. No new lesions, not on any steroids Partial Response (PR): >= 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions. Steriod dose must be no greater than max used in 1st 8wks of therapy Stable: not qualify for CR, PR, or progression. Steriod dose must be no greater than max used in 1st 8wks of therapy Progression (PD): 25% increase in the sum of products of all measurable lesions over smallest sum observed, OR clear worsening or failure to return for evalution due to death or deteriorating condition (unless clearly unrelated to brain cancer)."|at least 8 weeks of treatment|Response was reviewed only in those patients treated at the MTD (15mg temsirolimus)||participants|||Number
705871|NCT00112736|Primary|Safety/Dose Limiting Toxities Phase I|"Dose limiting toxities defined as: grade 3 thrombocytopenia, grade 4 anemia and neutropenia, grade >/= nonhematologic toxicity, and failure to recover from toxicites to be eligible for retreatment in 2 weeks of the last dose of either drug. Also grade 3 nonhematologic toxicities only if they wre refractory to maxiaml medical therapy.
MTD defined as dose at which fewer than one-third of patients experienced a DLT
Outcome measure defines number of participants who had a defined dose limiting toxicity."|first 4 weeks of treatment|||participants|||Number
705872|NCT00112736|Primary|Maximum Tolerated Dose (Phase I)|"Oral erlotinab at 150mg constant dose, 3 pts will be treated with temsirolimus IV with escalating doses, starting at 50mg. Doses will increase or decrease based on toxicity observed.
3 pts will be treated at each dose level - 3 dose levels were observed: 50mg, 25mg, and 15mg"|based on first 4 weeks of treatment - cycle 1|Per protocol -||mg|||Number
705873|NCT00112840|Secondary|Overall Survival (Phase I and II)|The overall survival or survival time is defined as the time from registration to death due to any cause. The distribution of overall survival will be estimated using the method of Kaplan-Meier.|Up to 3 years from study registration|All eligible participants were used for this endpoint.||months||95% Confidence Interval|Median
705874|NCT00112840|Secondary|Time to Progression (Phase II)|The time to progression is defined as the time from registration to the time of progression. Those who die will be considered to have had disease progression unless documented evidence clearly indicates no progression has occurred. The distribution of time to progression will be estimated using the method of Kaplan-Meier.|Up to 3 years from study registration|All eligible participants in Phase II were used for this endpoint.||months||95% Confidence Interval|Median
705875|NCT00112840|Secondary|Clinical Best Response Rate of CCI-779 and Bevacizumab in Patients With Metastatic Renal Cell (Phase II)|"The number of participants with clinical tumor response to treatment will be evaluated using the Response Evaluation Criteria In Solid Tumors (RECIST).
Complete Response (CR): Disappearance of all target lesions
Partial Response (PR): At least a 30% decrease in the sum of the largest dimension (LD) of target lesions taking as reference the baseline sum LD."|Up to 3 years from study registration|All eligible Phase II patients were used to assess this endpoint.||percentage of participants|||Number
705876|NCT00112840|Primary|Proportion of Progression-free Patients at 6 Months (Phase II)|Determination of progression will be made according to Response Evaluation Criteria in Solid Tumors (RECIST). A progression (PD) is defined as having at least a 20% increase in the sum of the longest dimension of target lesions taking as reference the smallest sum of the largest dimension recorded at baseline.The proportion of progression-free patients will be estimated by the number of successes divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the success proportion will be calculated. All patients meeting the eligibility criteria who have signed a consent form and begun treatment will be considered evaluable. Those who die will be considered to have had disease progression unless documented evidence clearly indicates no progression has occurred.|6 months after study entry|Only Phase II participants were analyzed for this endpoint. Forty participants from Phase II were evaluable for this endpoint.||percentage of participants||95% Confidence Interval|Number
705877|NCT00112840|Primary|Dose-limiting Toxicity (DLT) (Phase I)|"For this protocol, dose limiting toxicity (DLT) will be defined as an adverse event attributed (definitely, probably, or possibly) to the study treatment in the first four weeks of combination therapy, and meeting the following criteria:
Grade 4 Absolute neutrophil count (ANC) for 5+ days.
Grade 4 anemia or thrombocytopenia of any duration.
Serum Creatinine 2 times baseline or 2x upper limit of normal if baseline levels not normal.
Any other non-hematologic grade 3 or higher as per NCI Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0, except fatigue and grade 3 Hypertension that is will be controlled with oral medication.
Grade 3 triglycerides will be a DLT for patients who have Grade 3 in spite of appropriate lipid lowering drug therapy.
The maximum tolerated dose level (MTD) will be defined as the highest safely tolerated dose where 1 or 0 out of 6 patients experience DLT with the next higher dose."|Patients observed a minimum of 4 weeks (one full course). The maximum number of cycles observed was 16 cycles.|||participants|||Number
705878|NCT00112866|Other Pre-specified|Overall Progression Free Survival|Kaplan-meier curve|1 year|Overall survival based on the post surgical treatment. All patients received 2000mg post surgery. The pre-surgery dose was used for correlative purposes only. All patients received surgery and the doses pre-surgery have no relation to the this objective.||weeks||95% Confidence Interval|Median
705879|NCT00112866|Secondary|Tumor Tissue Concentrations|a section of tumor of approximately 500mg will be snap frozen (immediately prepared and frozen) once removed from brain for analysis of the drug concentration in contrast -enhancing tumor.|at time of surgery|8 500mg dose tissue samples and 10 2000mg dose tissue samples were either too small or had large areas of necrosis and gliosis to do analysis/evaluation||ng/g||Standard Deviation|Mean
705880|NCT00112866|Secondary|Plasma Concentration of EMD 121974|24 hour post dose concentration plasma, at time of resection|24 hour post concentration|6 of 8 and 7 of 11 plasma samples at the 500mg and 2000mg dose level respectively, were below the lower level of quantitation (LLOQ) Of the 15 samples in the low dose group only 8 were evaluable and 11 of the 15 for the high dose group. Samples were either damaged or too small for analysis.||ng/ml||Standard Deviation|Mean
705915|NCT00113087|Secondary|MacArthur-Bates Inventory -Words Understood|MacArthur-Bates Communicative Development inventory( Words and Gestures)-Words Understood z-score.|at 14 months of age|ITT, no imputation||standard deviation||Standard Deviation|Mean
705921|NCT00113087|Secondary|B-Type Natriuretic Peptide|B-Type Natriuretic Peptide (BNP) level.|Measured just prior to the Glenn surgery|ITT analysis, no imputation||pg/ml||Inter-Quartile Range|Median
705882|NCT00112866|Secondary|Changes in Tumor Cell Proliferation|Will be performed between the untreated matched control tumor tissue and the tissue obtained from the post-treatment tumors using either a Fisher’s Exact test or the Wilcoxon rank sum test depending on whether the assay provides a measurement or is yes/no.|Baseline and time of surgery|Molecular analyses evaluating alterations planned, unfortunately, majority of tumor samples were too small to do both measures of drug and molecular analysis or sample was inadequate for both after removal of areas of necrosis and gliosis|||||
705883|NCT00112866|Secondary|Changes in Tumor Cell Apoptosis|Will be performed between the untreated matched control tumor tissue and the tissue obtained from the post-treatment tumors using either a Fisher’s Exact test or the Wilcoxon rank sum test depending on whether the assay provides a measurement or is yes/no.|Baseline and time of surgery|Molecular analyses evaluating alterations planned, unfortunately, majority of tumor samples were too small to do both measures of drug and molecular analysis or sample was inadequate for both after removal of areas of necrosis and gliosis|||||
705884|NCT00112866|Secondary|Changes in Vitronectin Expression|Will be performed between the untreated matched control tumor tissue and the tissue obtained from the post-treatment tumors using either a Fisher’s Exact test or the Wilcoxon rank sum test depending on whether the assay provides a measurement or is yes/no.|Baseline and time of surgery|Molecular analyses evaluating alterations planned, unfortunately, majority of tumor samples were too small to do both measures of drug and molecular analysis or sample was inadequate for both after removal of areas of necrosis and gliosis|||||
705885|NCT00112866|Secondary|Changes in avb3 Integrin Expression on Tumor Cells and Endothelial Cells|Will be performed between the untreated matched control tumor tissue and the tissue obtained from the post-treatment tumors using either a Fisher’s Exact test or the Wilcoxon rank sum test depending on whether the assay provides a measurement or is yes/no.|Baseline and time of surgery|Molecular analyses evaluating alterations after cilengitide treatments were planned as a component of this clinical trial, unfortunately, the majority of tumor samples were too small to do both measures of drug and molecular analysis or the sample was inadequate for both after removal of areas of necrosis and gliosis|||||
705886|NCT00112866|Primary|6m-Progression-free Survival|progression within 6 months (26 weeks) of treatment|6 months|6months progression free survival based on the post surgical treatment. All patients received 2000mg post surgery. The pre-surgery dose was used for correlative purposes only. All patients received surgery and the doses pre-surgery have no relation to the primary objective.||percent|||Number
705887|NCT00112905|Secondary|Best Overall Response by RECIST|"This outcome measure reports the best response a patient has ever experienced.
<Target Lesions>
Complete Response (CR):
The disappearance of all target lesions, confirmed by assessments >=4 weeks (wks) later.
Partial Response:
>=30% decrease in the sum of the longest diameters of target lesions from baseline, confirmed by assessments >=4 wks later.
Progressive Disease (PD):
>=20% increase in the sum of the longest diameters of target lesions from the smallest sum longest diameter since baseline, or the appearance of new lesions.
Stable Disease (SD):
Neither response criteria nor progressive disease criteria are met for >=8 wks.
<Nontarget Lesions>
CR:
The disappearance of all nontarget lesions and normalization of tumor marker levels, confirmed by assessments >=4 wks later.
SD:
Persistence of nontarget lesions or maintenance of tumor marker levels above the normal limits for >=8 wks.
PD:
The appearance of new lesions or unequivocal progression of existing lesions."|Assessed every cycle while on treatment; after being off-treatment, assessed every 3 months for 2 years, then every 6 months for 1 year.|Only eligible and treated patients are included in the analysis.||Participants|||Number
705888|NCT00112905|Secondary|Overall Survival|Time from registration to death. Patients alive at last follow-up were censored.|Assessed every cycle while on treatment; after being off-treatment, assessed every 3 months for 2 years, then every 6 months for 1 year.|Only eligible and treated patients are included in this analysis.||Months||90% Confidence Interval|Median
705889|NCT00112905|Secondary|Progression-free Survival|"Time from registration to the earlier of disease progression or death. Patients alive and progression-free at last follow-up were censored.
Progression is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s) or unequivocal progression of existing nontarget lesions."|Assessed every cycle while on treatment; after being off-treatment, assessed every 3 months for 2 years, then every 6 months for 1 year.|Only eligible and treated patients are included in this analysis.||Months||90% Confidence Interval|Median
705890|NCT00112905|Primary|Kaplan-Meier Estimate of Progression-free Survival at 4 Months|"Survival estimate from the Kaplan-Meier curve of the proportion of patients alive and progression-free at 4 months.
Progression-free survival is defined as the time from registration to progression or death, whichever occurs first.
Progression is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s) or unequivocal progression of existing nontarget lesions."|Assessed every cycle while on treatment; after being off-treatment, assessed every 3 months for 2 years, then every 6 months for 1 year.|Per protocol, the primary analysis included eligible patients who started protocol treatment.||Percentage of Participants||90% Confidence Interval|Number
705891|NCT00112918|Secondary|Overall Survival in Stage III Cancer Patients - Number of Events: Final Analysis|An overall survival event was death due to any cause.|From first patient randomized until the final data cut-off date of 30 June 2012 (5 years after the last patient randomized).|ITT patients with Stage III disease.||participants|||Number
705892|NCT00112918|Secondary|Overall Survival in Stage III Cancer Patients - Time to Event: Final Analysis|Overall survival was defined as the time between date of randomization and date of death due to any cause. Patients not reported as having died at the time of the clinical cut-off date (30 June 2012) were censored at the date they were last known to be alive.|From first patient randomized until the final data cut-off date of 30 June 2012 (5 years after the last patient randomized).|ITT patients with Stage III disease.||months||95% Confidence Interval|Median
705893|NCT00112918|Secondary|Overall Survival in Stage III Cancer Patients - Number of Events|An overall survival event was death due to any cause.|From first patient randomized until the clinical data cut-off date of 30 June 2010 (36 months after the last patient randomized).|ITT patients with Stage III disease.||participants|||Number
706054|NCT00104572|Secondary|Effect of Testosterone Gel vs. Anastrozole on Glucose Tolerance/Lipid Metabolism|Oral glucose tolerance test (Glucose/Insulin), lipid profile, abdomen fat|1 year||07/2016||||
705894|NCT00112918|Primary|Disease-free Survival in Stage III Cancer Patients - Number of Events|A disease-free survival (DFS) event was composed of a recurrence, a new occurrence of colorectal cancer or death due to any cause. Recurrence and new occurrence of colorectal cancer were based on tumor assessments made by the investigator. Triggering events for DFS are reported; a patient can have both recurrence and a new occurrence of colon cancer.|From first patient randomized until the data cut-off date of 30 June 2010 (36 months after the last patient randomized).|The primary population for efficacy analyses was the intent to treat population (ITT; all randomized patients) with stage III disease.||participants|||Number
705895|NCT00112918|Secondary|Overall Survival in Stage III Cancer Patients - Time to Event|Overall survival was defined as the time between date of randomization and date of death due to any cause. Patients not reported as having died at the time of the analysis were censored at the date they were last known to be alive.|From first patient randomized until the clinical data cut-off date of 30 June 2010 (36 months after the last patient randomized).|ITT patients with Stage III disease.||months||95% Confidence Interval|Median
705896|NCT00112918|Primary|Disease-free Survival in Stage III Cancer Patients - Time to Event|Disease-free survival (DFS) was defined as the time from the date of randomization to the time of a recurrence, a new occurrence of colorectal cancer or death due to any cause, whichever occurred first. Patients without an event were censored at the last date the patient was known to be disease-free. Recurrence and new occurrence of colorectal cancer were based on tumor assessments made by the investigator. Patients with no tumor assessments after baseline but still alive at the time of the clinical cut-off were censored at day 1.|From first patient randomized until the data cut-off date of 30 June 2010 (36 months after the last patient randomized).|The primary population for efficacy analyses was the intent to treat population (ITT; all randomized patients) with stage III disease.||months||95% Confidence Interval|Median
705897|NCT00113022|Primary|Montgomery-Asberg Depression Rating Scale (MADRS)|The MADRS is a measure of depression severity examined on a weekly basis. The minimum score on the 10 item scale is 0 indicating no depression. The maximum score is 60 indicating a very severe depression. Scores of 18 and above are generally considered to suggest significant levels of depression.|8 weeks|||Scores on a scale||Standard Error|Least Squares Mean
705898|NCT00113087|Secondary|Number of Participants With Moderate to Severe AV Valve Regurgitation|Number of participants with moderate to severe AV valve regurgitation.|at age 14 months|ITT, no imputation||participants|||Number
705899|NCT00113087|Secondary|Number of Participants With Moderate to Severe AV Valve Regurgitation|Number of participants with Moderate to severe AV valve regurgitation.|just before the pre-Glenn surgery|ITT, no imputation||participants|||Number
705900|NCT00113087|Secondary|Ventricular Filling Pressure|Ventricular filling pressure measured by catherization|just before the Glenn surgery|ITT, no imputation||mmHg||Standard Deviation|Mean
705901|NCT00113087|Secondary|Ventricular Mass to Volume Ratio|Two-Dimensional Echocardiography endpoint -Ventricular Mass to Volume ratio per Core Laboratory assessment.|Measured at 14 months of age|Intention-to-treat analysis of participants completing the final study visit (target visit window age 14 months)||g/ml||Standard Deviation|Mean
705902|NCT00113087|Secondary|Ventricular Mass to Volume Ratio|Two-Dimensional Echocardiography endpoint -Ventricular Mass to Volume ratio per Core Laboratory assessment.|Measured just before the Glenn surgery|Intention-to-treat analysis of participants completing the pre-Glenn visit||g/ml||Standard Deviation|Mean
705903|NCT00113087|Secondary|End-diastolic Volume Z-score|Two-dimensional echocardiography endpoint -total end-diastolic volume z-score per Core Laboratory assessment.|at 14 months of age|ITT, no imputation||standard deviation||Standard Deviation|Mean
705904|NCT00113087|Secondary|End Diastolic Volume Z-score|Two-dimensional echocardiography endpoint -total End diastolic volume z-score per Core Laboratory assessment.|just before the Glenn surgery|ITT, no imputation||standard deviation||Standard Deviation|Mean
705905|NCT00113087|Secondary|End-diastolic Volume|Two-Dimensional Echocardiography endpoint - Total End-diastolic volume (ml) per Core Laboratory assessment.|at 14 months of age|ITT, no imputation||ml||Standard Deviation|Mean
705906|NCT00113087|Secondary|End-diastolic Volume|Two-Dimensional Echocardiography endpoint - Total End-diastolic volume (ml) per Core Laboratory assessment.|just before the Glenn surgery|ITT, no imputation||ml||Standard Deviation|Mean
705907|NCT00113087|Secondary|Ventricular Mass Z-score|Two-dimensional echocardiography endpoint -Total Ventricular mass z-score per Core Laboratory assessment.|at 14 months of age|ITT, no imputation||standard deviation||Standard Deviation|Mean
705908|NCT00113087|Secondary|Ventricular Mass Z-score|Two-dimensional echocardiography endpoint -Total Ventricular mass z-score per Core Laboratory assessment.|just before the Glenn surgery|ITT, no imputation||standard deviation||Standard Deviation|Mean
705909|NCT00113087|Secondary|Ventricular Mass|Two-Dimensional Echocardiography endpoint-Total Ventricular mass (g) per Core Laboratory assessment. Range from 15.60 to 70.40|At 14 months of age|ITT, no imputation||g||Standard Deviation|Mean
705910|NCT00113087|Secondary|Ventricular Mass|Two-dimensional echocardiography endpoint - Total Ventricular mass (g) per Core Laboratory assessment.|just before the Glenn surgery|ITT, no imputation||g||Standard Deviation|Mean
705911|NCT00113087|Secondary|Ejection Fraction (%)|Two-dimensional echocardiography endpoint -Total Ejection Fraction (%) per Core Laboratory assessment. Ejection Fraction (%) is defined as percentage of stroke volume of a ventricle (i.e. the difference between end diastolic and end systolic volumes)relative to end diastolic volume.|at 14 months of age|ITT, no imputation||percent (of end diastolic volume)||Standard Deviation|Mean
705912|NCT00113087|Secondary|Ejection Fraction (%)|Two-dimensional echocardiography endpoint -Total Ejection Fraction (%) per Core Laboratory assessment. Ejection Fraction % is defined as the percentage of the stroke volume (i.e. difference between end-diastolic and end-systolic volumes) in a ventricle relative to end-diastolic volume.|just before the Glenn surgery|ITT, no imputation||percent (of end diastolic volume)||Standard Deviation|Mean
705913|NCT00113087|Secondary|MacArthur-Bates Inventory -Words Produced|MacArthur-Bates Communicative Development inventory( Words and Gestures)-Words Produced z-score.|at 14 months of age|ITT, no imputation||standard deviation||Inter-Quartile Range|Median
705914|NCT00113087|Secondary|MacArthur-Bates Inventory -Total Gestures|MacArthur-Bates Communicative Development inventory( Words and Gestures)-Total Gestures z-score.|at 14 months of age|ITT, no imputation||standard deviation||Standard Deviation|Mean
706055|NCT00104572|Secondary|Effect of Testosterone Gel vs. Anastrozole on Pulsatile Growth Hormone Release|Overnight Growth hormone measures|1 year||12/2016||||
705922|NCT00113087|Secondary|Number of Participants With Ross Heart Failure Class I|Class I is defined as having no limitations or symptoms of heart failure. Classes II to IV include increasing degrees of growth failure, prolonged feeding time, tachypnea, diaphoresis, and in older children, dyspnea on exercise.|Measured at 14 months of age|Intention-to-treat analysis of participants completing the final study visit (target visit window age 14 months)||participants|||Number
705923|NCT00113087|Secondary|Number of Participants With Ross Heart Failure Class I|Class I is defined as having no limitations or symptoms of heart failure. Classes II to IV include increasing degrees of growth failure, prolonged feeding time, tachypnea, diaphoresis, and in older children, dyspnea on exercise.|Just prior to the pre-Glenn surgery|Intention-to-treat analysis of participants measured just prior to the Glenn surgery||Participants|||Number
705924|NCT00113087|Secondary|Head Circumference-for-age Z-score|Head circumference-for-age z-score at 14 months of age.In primary analysis outcome is defined as predicted mean of Head circumference z-score at age 14 months based on longitudinal modeling(and adjusted for baseline values)|Measured at baseline, 2 weeks after starting study drug, just prior to the Glenn surgery, 7 days after restarting drug following the Glenn surgery, at 10 months of age, and at 14 months of age|ITT, no imputation||standard deviation||Standard Error|Least Squares Mean
705925|NCT00113087|Secondary|Height-for-age Z-score|Height-for-age z-score at 14 months of age. In primary analysis outcome is defined as predicted mean of height z-score at age 14 months based on longitudinal modeling (adjusted bor baseline value)|Measured at baseline, 2 weeks after starting study drug, just prior to the Glenn surgery, 7 days after restarting drug following the Glenn surgery, at 10 months of age, and at 14 months of age|||standard deviation||Standard Error|Least Squares Mean
705926|NCT00113087|Primary|Weight-for-age Z-score at 14 Months of Age|Weight-for-age z-score at 14 months of age. In primary analysis outcome is defined as predicted mean of weight z-score at age 14 months based on longitudinal modeling(and adjusted for baseline values)|Measured at baseline, 2 weeks after starting study drug, just prior to the Glenn surgery, 7 days after restarting drug following the Glenn surgery, at 10 months of age, and at 14 months of age|ITT, no imputation||standard deviation||Standard Error|Least Squares Mean
705927|NCT00113217|Secondary|Safety of Treatment|Safety measured by participant toxicities in therapy with bevacizumab for Renal Cell Carcinoma (RCC).|Following 56 days treatment||||||
705928|NCT00113217|Primary|Progression Free Survival (PFS)|Time to progression calculated from the start of the study drug to the first evidence of disease progression. Time to progression reported as PFS measured in months. Progression (or progressive disease) defined by Response Evaluation Criteria in Solid Tumors (RECIST) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Up to 3 years (or until disease progression)|||months||95% Confidence Interval|Median
705929|NCT00113230|Primary|Pathologic Local Tumor Response|At follow-up evaluation after completion of neoadjuvant and surgical therapy, resected primary tumor classified based on routine pathology staining in the following manner: Pathologic Complete Response (no evidence of residual cancer); Microscopic Residual (no grossly detected disease, but evidence of microscopic residual disease); and Gross Residual Disease.|Baseline to approximately 5 Months (Following 28 days of treatment, chemotherapy and surgical resection of tumor)|Intention to treat analysis method. Data examination conducted upon enrollment and evaluability of 25 patients.||Participants|||Number
705930|NCT00113269|Secondary|Renal Function Abnormalities Based on Serum Creatinine|"Decrease in serum creatinine usually indicates an improvement.
Change in creatinine clearance from month 1 was calculated.
Change from 1 month is calculated by month 36 – month 1."|1 month and End of Study (36 months)|The number of participants analyzed represents Full Analysis Set: all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug. Only patients with the test result at a given time point were included in each time point analysis, and these numbers are noted in the category titles as “N”.||mcmol/L||Standard Deviation|Mean
705931|NCT00113269|Secondary|Renal Function Abnormalities Based on Creatinine Clearance|"Increases in creatinine clearance usually indicates an improvement.
Change in creatinine clearance from month 1 was calculated.
Change from 1 month is calculated by month 36 – month 1."|1 month and End of Study (36 months)|The number of participants analyzed represents Full Analysis Set: all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug. Only patients with the test result at a given time point were included in each time point analysis, and these numbers are noted in the category titles as “N”.||mL/s||Standard Deviation|Mean
705932|NCT00113269|Secondary|Overall Patient Survival|"Overall patient survival is defined as not dead at any time following skin closure. Data is reported as the percentage of patients with Overall Patient Survival.
End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months."|End of Study (36 months)|The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug.||Percentage of Patients|||Number
705933|NCT00113269|Secondary|Patient Survival at 12 Months|"Patient survival is defined as not dead within 12 months after skin closure.
Kaplan Meier analysis was used to estimate percentage of patients with event. Patients with no event by the time of the scheduled visit or whose first event was after premature discontinuation of randomized study drug or tacrolimus were censored on the scheduled day of assessment, on the day of premature treatment discontinuation or last evaluation day, whichever came first."|12 months|The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug.||Percentage of Patients|||Number
705934|NCT00113269|Secondary|Overall Graft Survival|"Overall graft survival is defined as not having graft loss (re-transplant, return to dialysis for more than 30 consecutive days, or death) at any time following skin closure. Data is reported as the percentage of patients with Overall Graft Survival.
End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months."|End of Study (36 months)|The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug.||Percentage of Patients|||Number
706056|NCT00104572|Secondary|Effect of Testosterone Gel vs. Anastrozole on Cognitive Function|MRI images|1 year||12/2016||||
705935|NCT00113269|Secondary|Graft Survival at 12 Months|"Graft survival is defined as no graft loss (re-transplant, return to dialysis for more than 30 days or death) with 12 months of skin closure.
Kaplan Meier analysis was used to estimate percentage of patients with event. Patients with no event by the time of the scheduled visit or whose first event was after premature discontinuation of randomized study drug or tacrolimus were censored on the scheduled day of assessment, on the day of premature treatment discontinuation or last evaluation day, whichever came first."|12 months|The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug.||Percentage of Patients|||Number
705936|NCT00113269|Secondary|Time to First BCAR|"Time to first BCAR is defined as the number of days from skin closure to the first episode of BCAR.
End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months."|End of Study (36 months)|"The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug.
Only patients who experienced BCAR were included in the analysis."||Days||Full Range|Median
705937|NCT00113269|Secondary|Clinically Treated Acute Rejection|"Clinically treated acute rejection is defined as patient incidence of any rejection (suspected or otherwise) for which treatment was provided. Data is reported as the percentage of patients with Clinically Treated Acute Rejection.
End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months."|End of Study (36 months)|The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug.||Percentage of Patients|||Number
705938|NCT00113269|Secondary|Efficacy Failure|"Efficacy Failure is a composite measure of biopsy confirmed acute rejection, graft loss and death. Data is reported as the percentage of patients with Efficacy Failure.
End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months."|End of Study (36 months)|The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug.||Percentage of Patients|||Number
705939|NCT00113269|Secondary|Overall Patient Incidence of BCAR|"Overall patient incidence of BCAR is defined as a suspected new rejection at any time following skin closure confirmed by a Banff Grade ≥ 1A as assigned by a local pathologist. Incidence is reported as the percentage of patients with BCAR. The Banff 97 scale is a classification system for interpreting histology of allograft biopsies. The grades range from Mild (1A & 1B) to Moderate (2A & 2B) to Severe (3).
End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months."|End of Study (36 months)|The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug.||Percentage of Patients|||Number
705940|NCT00113269|Primary|Patient Incidence of Biopsy-confirmed Acute Rejection (BCAR) at 6 Months|"A BCAR is a suspected new rejection w/in 6 mos. of skin closure, confirmed by Banff Grade ≥1A assigned by a pathologist. The Banff 97 classification system is used for interpreting histology of allograft biopsies, including Mild (1A/1B), Moderate (2A/2B) & Severe (3).
Kaplan Meier analysis was used to estimate % of pts. w/event. Patients w/no event at time of scheduled visit or whose 1st event was after premature discontinuation of study drug/tacrolimus were censored on the scheduled day of a) assessment, b) of premature treatment discontinuation or c) last evaluation, whichever came 1st."|6 months|The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug.||Percentage of Patients||95% Confidence Interval|Number
705941|NCT00113295|Secondary|The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q).|The 16-item Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) is used to assess quality of life changes with treatment. Total scores range from 14-70, with higher levels of satisfaction yielding higher scores.|Week 10 (Phase 1 Endpoint) and Week 18 (Phase 2 Endpoint)|||units on a scale||Standard Deviation|Mean
705942|NCT00113295|Secondary|Depressive Symptoms, Montgomery–Asberg Depression Rating Scale (MADRS)|Depressive symptoms were measured at a secondary outcome using the Montgomery–Asberg Depression Rating Scale (MADRS). Each item is scored on a scale of 1-6; The total score range is 0-60, with higher scores indicated higher levels of depression severity.|Week 10 (Phase 1 Endpoint) and Week 18 (Phase 2 Endpoint)|||units on a scale||Standard Deviation|Mean
705943|NCT00113295|Secondary|Response, Clinical Global Impression of Improvement (CGI-I)|Response was measured as a secondary outcome using the Clinical Global Impression of Improvement (CGI-I). Response was defined as a score of 1 [“very much improved”] or 2 [“much improved”] at study endpoint.|Week 18 (Phase 2 Endpoint)|||participants|||Number
705944|NCT00113295|Primary|Hamilton Anxiety Scale (HAM-A) Score at Study Endpoint.|"Symptoms of generalized anxiety disorder as measured by the Hamilton Anxiety Scale (HAM-A) at week 18/study endpoint. Each item is scored on a scale from 0 (not present) to 4 (severe) with a total score range of 0-56. Changes in HAM-A scores are calculated as the difference between the baseline HAM-A scores and scores at week 18/study endpoint.
The 14-item Hamilton Anxiety Rating Scale (HAM-A) (Hamilton, 1959) was developed to assess anxiety in a clinical population. It is considered a measure of general anxiety across anxiety disorders, in addition to being a gold standard measure for GAD."|Baseline and Week 18|Twenty-two patients were randomized, 11 to quetiapine and 11 to placebo augmentation, and all had at least one assessment postrandomization and were included in the phase 2 efficacy analyses; of this group, six randomized to quetiapine (54.5%) and ten to placebo (90.1%) completed the trial.||units on a scale||Standard Deviation|Mean
705945|NCT00113295|Secondary|Remission (HAM-A ≤ 7)|Remission was measured as a secondary outcome using a score of less than or equal to 7 on the Hamilton Anxiety Scale (HAM-A).|Week 18 (Study Endpoint)|||participants|||Number
705946|NCT00113321|Primary|Overall Response|Participants with Overall Response, categorized as 'Complete Response' to represent remission or 'No Complete Response' for lack of remission. Response evaluation after completing one course of therapy (8-12 weeks), then bone marrow aspiration to document remission every 1-3 courses.|Blood tests baseline and after completing 8-12 weeks of therapy|Treated population (16 patients); No further analysis done since study terminated early due to low accrual.||Participants|||Number
705947|NCT00113334|Primary|Response Rate|Response rate defined as percentage of number of complete response or partial response in total number of participants treated. Response Evaluation Criteria in Solid Tumors (RECIST): Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): >30% decrease in sum longest diameter (LD) of target lesions, reference baseline sum LD; Progressive Disease (PD): >20% increase in sum LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of 1/> new lesions; Stable Disease (SD): Neither sufficient shrinkage for PR nor sufficient increase for PD, reference smallest sum LD. Trial conducted by Simon’s optimal two-stage design and response rate estimated accordingly. For status of PR or CR, changes in tumor measurements confirmed by repeat assessments performed at 6 weeks, no less than 4 weeks after criteria for response is first met.|Baseline to 6 weeks for PR or CR response assessment (minimal 4 week cycle + assessments). Overall study period 3 years.|Three (3) patients were inevaluable for response.||participants|||Number
705948|NCT00113360|Primary|Progression Free Survival (PFS)|PFS is measured from date of trial entry until documented progression of disease or death from any cause. PFS is measured by computed tomography (CT) scans or magnetic resonance imaging (MRI) performed at baseline and after every three cycles.|PFS assessed every 12 weeks (at the end of every 3 cycles) or more frequently if clinically indicated|Per protocol||Weeks||95% Confidence Interval|Median
705949|NCT00113373|Secondary|Prognostic Variables: Platinum Sensitivity, Performance Status, and Cellular Histology (Clear Cell or Mucinous Type)|An analysis of any potential treatment effect on PFS or overall survival may be conducted against historical controls using a proportional hazards model that includes histological cell type, performance status, and platinum sensitivity.|Up to 5 years||||||
705950|NCT00113373|Secondary|Overall Survival|The observed length of life from entry into the study to death or the date of last contact.|From entry into the study to death or the date of last contact, assessed up to 5 years|Eligible and Treated Patients||months||95% Confidence Interval|Median
705951|NCT00113373|Secondary|Duration of Progression-free Survival|An analysis of any potential treatment effect on PFS or overall survival may be conducted against historical controls using a proportional hazards model that includes histological cell type, performance status, and platinum sensitivity.|From study entry until disease progression, death or date of last contact, assessed up to 5 years||||||
705952|NCT00113373|Secondary|Tumor Response|Complete and Partial Tumor Response by Response Evaluation Criteria In Solid Tumors (RECIST) 1.0|For those patients whose disease can be evaluated by physical examination, response was assessed prior to each 28-day cycle. CT scan or MRI if used to follow measurable disease every other cycle for the first 6 months; every 6 months thereafter.|Eligible and Treated Patients||percentage of participants||90% Confidence Interval|Number
705953|NCT00113373|Primary|Frequency and Severity of Adverse Effects as Assessed by Common Toxicity Criteria for Adverse Events (CTCAE) v3.0||Up to 5 years||||||
705954|NCT00113373|Primary|Progression-free Survival (PFS) > 6 Months|Whether or not the patient survived progression-free for at least 6 months.|For those patients whose disease can be evaluated by physical examination, progression was assessed prior to each 28-day cycle. CT scan or MRI if used to follow measurable disease every other cycle for the first 6 months; every 6 months thereafter.|Eligible and Treated Patients||percentage of participants||90% Confidence Interval|Number
705955|NCT00113386|Primary|Comparison of Overall Survival||Date of death or date of last follow-up|This study terminated early with 19 out of 574 subjects accrued. Therefore no analysis was performed.|||||
705956|NCT00113399|Primary|Overall Survival||Date of death or last follow-up|This study terminated early with 15 subjects out of 240 subjects accrued, therefore no analyses were performed.|||||
705957|NCT00103610|Secondary|Graft Durability at 12 Months Post Transplantation|The proportion of participants maintaining a durable graft 12 months post-transplantation by at least 2 of the following criteria (without erythropoietin (EPO), G-CSF, or transfusions): (1) a platelet count >50000/µL without transfusion for at least 2 weeks, (2) hemoglobin >=10g/dL for at least 1 month, (3) and absolute neutrophil count >1000/µL for at least 1 week.|approximately Month 13|Participants who received a stem cell transplant and were evaluable at 12 months post-transplant||proportion of participants|||Number
705958|NCT00103610|Secondary|Graft Durability at 6 Months Post Transplantation|The proportion of participants maintaining a durable graft at 6 months post transplantation by at least 2 of the following criteria (without erythropoietin (EPO), G-CSF, or transfusions): (1) a platelet count >50000/µL without transfusion for at least 2 weeks, (2) hemoglobin >=10g/dL for at least 1 month, (3) and absolute neutrophil count >1000/µL for at least 1 week.|approximately Month 7|Participants who received a stem cell transplant and were evaluable at 6 months post-transplant||proportion of participants|||Number
705959|NCT00103610|Secondary|Graft Durability at 100 Days Post Transplantation|The proportion of participants maintaining a durable graft at 100 days post transplantation by at least 2 of the following criteria (without erythropoietin (EPO), G-CSF, or transfusions): (1) a platelet count >50000/µL without transfusion for at least 2 weeks, (2) hemoglobin >=10g/dL for at least 1 month, (3) and absolute neutrophil count >1000/µL for at least 1 week.|approximately Day 138|Participants who received a stem cell transplant and were evaluable at 100 days post-transplant||proportion of participants|||Number
705960|NCT00103610|Secondary|Median Number of Days to Platelet (PLT) Engraftment|The Kaplan Meier estimate of median number of days to PLT engraftment (number of days at which 50% of participants have experienced the event, accounting for censored values) was a secondary efficacy endpoint. Engraftment was defined as ≥ 20*10^9/L without transfusion for the preceding 7 days. Time to engraftment corresponded to the first day that the criteria were met.|Up to Month 13|Participants who received a stem cell transplant||Days||Inter-Quartile Range|Median
705961|NCT00103610|Secondary|Median Number of Days to Polymorphonuclear (PMN) Cell Engraftment|The Kaplan Meier estimate of median number of days to PMN engraftment (number of days at which 50% of participants have experienced the event, accounting for censored values) was a secondary efficacy endpoint. Engraftment was defined as PMN counts ≥ 0.5*10^9/L for 3 consecutive days or ≥ 1.0*10^9/L for 1 day. Time to engraftment corresponded to the first day that the criteria were met.|Up to Month 13|Participants who received a stem cell transplant.||Days||Inter-Quartile Range|Median
705962|NCT00103610|Secondary|Median Number of Days of Apheresis Required to Achieve >=5*10^6 CD34+ Cells/kg|The Kaplan Meier estimate of median number of days (number of days at which 50% of participants reached the threshold, accounting for censored values) in each treatment arm to collect the target number of cells (≥5*10^6 CD34+ cells/kg) for transplantation. Central laboratory values were used.|up to Day 8|Intent-to-Treat Population.||Days||Inter-Quartile Range|Median
705963|NCT00103610|Secondary|Proportion of Participants Able to Achieve Target (>=2*10^6 CD34+ Cells/kg) in 4 or Fewer Days of Apheresis|Proportion of participants achieving a target of >=2*10^6 CD34+ Cells/kg in 4 or fewer days of apheresis. Central lab data were taken from Days 5 to 8 of the Treatment/Apheresis period. Each participant's value was calculated as the sum of all daily values collected over the 4 apheresis days.|up to Day 8|Intent-to-treat Population||proportion of participants|||Number
705964|NCT00103610|Secondary|Number of Participants With Adverse Events|Number of participants with treatment emergent adverse events (AEs). The timeframe for treatment emergent AEs is defined as Day 1 (start of G-CSF Mobilization) to the day before starting chemotherapy (approximately 38 days later). AEs were reported regardless of relationship to study treatment. The investigator graded each AE using the World Health Organization (WHO) Adverse Event Grading Scale. AEs of Grade 3 were considered severe and Grade 4 were considered life-threatening.|up to Day 38|Safety population of all participants who received at least 1 mobilization dose of G-CSF or study treatment (plerixafor or placebo). Three participants did not receive G-CSF or any study treatment and were excluded from the safety analyses.||participants|||Number
705965|NCT00103610|Primary|Proportion of Participants Able to Achieve Target (≥ 5*10^6 CD34+ Cells/kg) in 4 or Fewer Days of Apheresis|Proportion of participants achieving a target of ≥ 5*10^6 CD34+ cells/kg in 4 or fewer days of apheresis. Central lab data were taken from Days 5 to 8 of the Treatment/Apheresis period. Each participant’s value was calculated as the sum of all daily values collected over the 4 apheresis days.|Days 5 to 8|Intent-to-Treat Population||proportion of participants|||Number
705966|NCT00103662|Secondary|Graft Durability at 12 Months Post Transplantation|The proportion of participants maintaining a durable graft at 12 months post-transplantation by at least 2 of the following criteria (without erythropoietin (EPO), G-CSF, or transfusions): (1) a platelet count >50000/µL without transfusion for at least 2 weeks, (2) hemoglobin >=10g/dL for at least 1 month, (3) and absolute neutrophil count >1000/µL for at least 1 week.|approximately Month 13|Participants who received a stem cell transplant and were evaluable at 12 months post-transplant||proportion of participants|||Number
705967|NCT00103662|Secondary|Graft Durability at 6 Months Post Transplantation|The proportion of participants maintaining a durable graft at 6 months post-transplantation by at least 2 of the following criteria (without erythropoietin (EPO), G-CSF, or transfusions): (1) a platelet count >50000/µL without transfusion for at least 2 weeks, (2) hemoglobin >=10g/dL for at least 1 month, (3) and absolute neutrophil count >1000/µL for at least 1 week.|approximately Month 7|Participants who received a stem cell transplant and were evaluable at 6 months post-transplant||proportion of participants|||Number
705968|NCT00103662|Secondary|Graft Durability at 100 Days Post Transplantation|The proportion of participants maintaining a durable graft at 100 days post-transplantation by at least 2 of the following criteria (without erythropoietin (EPO), G-CSF, or transfusions): (1) a platelet count >50000/µL without transfusion for at least 2 weeks, (2) hemoglobin >=10g/dL for at least 1 month, (3) and absolute neutrophil count >1000/µL for at least 1 week.|approximately Day 138|Participants who received a stem cell transplant and were evaluable at 100 days post-transplant||proportion of participants|||Number
705969|NCT00103662|Secondary|Median Number of Days to Platelet (PLT) Engraftment|The Kaplan Meier estimate of median number of days to PLT engraftment (number of days at which 50% of participants have experienced the event, accounting for censored values) was a secondary efficacy endpoint. Engraftment was defined as ≥ 20*10^9/L without transfusion for the preceding 7 days. Time to engraftment corresponded to the first day that the criteria were met and was evaluated up to 12 months post transplant.|Up to Month 13|Participants who received a stem cell transplant||Days||Inter-Quartile Range|Median
705970|NCT00103662|Secondary|Median Number of Days to Polymorphonuclear (PMN) Cell Engraftment|The Kaplan Meier estimate of median number of days to PMN engraftment (number of days at which 50% of participants have experienced the event, accounting for censored values) was a secondary efficacy endpoint. Engraftment was defined as PMN counts ≥ 0.5*10^9/L for 3 consecutive days or ≥ 1.0*10^9/L for 1 day. Time to engraftment corresponded to the first day that the criteria were met and was evaluated up to 12 months post transplant.|Up to Month 13|Participants who received a stem cell transplant.||Days||Inter-Quartile Range|Median
705971|NCT00103662|Secondary|Median Number of Days to ≥6*10^6 CD34+ Cells/kg|The Kaplan Meier estimate of median number of days (number of days at which 50% of participants have experienced the event, accounting for censored values) in each treatment arm to collect an optimum number of cells (≥6*10^6 CD34+ cells/kg) for transplantation.|up to Day 8|Intent-to-treat population||Days||Inter-Quartile Range|Median
705972|NCT00103662|Secondary|Proportion of Participants Achieving a Target of ≥ 2*10^6 CD34+ Cells/kg in 4 or Fewer Days of Apheresis.|Proportion of participants achieving a target of ≥ 2*10^6 CD34+ cells/kg in 4 or fewer days of apheresis. Central lab data were taken from Days 5 to 8 of the Treatment/Apheresis period. Each participant's value was calculated as the sum of all daily values collected over the 4 apheresis days.|up to Day 8|Intent-to-Treat Population||proportion of participants|||Number
705973|NCT00103662|Secondary|Proportion of Participants Achieving a Target of ≥ 6*10^6 CD34+ Cells/kg in 4 or Fewer Days of Apheresis.|Proportion of participants achieving a target of ≥ 6*10^6 CD34+ cells/kg in 4 or fewer days of apheresis. Central lab data were taken from Days 5 to 8 of the Treatment/Apheresis period. Each participant's value was calculated as the sum of all daily values collected over the 4 apheresis days.|up to Day 8|Intent-to-Treat Population||proportion of participants|||Number
705974|NCT00103662|Secondary|Number of Participants With Adverse Events|Number of participants with treatment emergent adverse events (AEs). The timeframe for treatment emergent AEs is defined as Day 1 (start of G-CSF Mobilization) to the day before starting chemotherapy (approximately 38 days later). AEs were reported regardless of relationship to study treatment. The investigator graded each AE using the World Health Organization (WHO) Adverse Event Grading Scale. AEs of Grade 3 were considered severe and Grade 4 were considered life-threatening.|up to Day 38|Primary Safety population of all participants who received at least 1 mobilization dose of G-CSF or study treatment (plerixafor or placebo). Four participants did not receive G-CSF or any study treatment and were excluded from the safety analyses.||participants|||Number
705975|NCT00103662|Primary|Proportion of Participants Achieving a Target of ≥ 6*10^6 CD34+ Cells/kg in 2 or Fewer Days of Apheresis.|Proportion of participants achieving a target of ≥ 6*10^6 CD34+ cells/kg in 2 or fewer days of apheresis. Central lab data were taken from Days 5 to 6 of the Treatment/Apheresis period. Each participant's value was calculated as the sum of all daily values collected over the 2 apheresis days.|up to Day 6|Intent-to-Treat Population||proportion of participants|||Number
705976|NCT00103740|Secondary|Number of Participants With a Disease Relapse During the Extended Observation Period|Extended observation period. A disease relapse was defined as the occurrence of a serum alkaline phosphatase level that was >= 80% of baseline serum alkaline phosphatase value.|8 years was maximum|Extended modified Intent-to-treat population: patients who had at least one serum alkaline phosphatase measurement during the extension period.||participants|||Number
705977|NCT00103740|Secondary|Number of Participants With a Partial Disease Relapse During the Extended Observation Period|Extended observation period. A partial disease relapse was defined as an increase in serum alkaline phosphatase >= 50% from the serum alkaline phosphatase measurement at Month 6 and at least 1.25 times the upper normal limit.|8 years was the maximum|Extended modified Intent-to-treat population: patients who had at least one serum alkaline phosphatase measurement during the extension period.||participants|||Number
705978|NCT00103740|Secondary|Number of Participants With a Loss of Therapeutic Response During the Extended Observation Period|Extended observation period. A therapeutic response is defined as a reduction of at least 75% from baseline in serum alkaline phosphatase excess or normalization of serum alkaline phosphatase.|8 years was the maximum|Extended modified Intent-to-treat population: patients who had at least one serum alkaline phosphatase measurement during the extension period.||participants|||Number
705979|NCT00103740|Secondary|Change in Pain Interference at Day 182|Change in pain interference score from Brief Pain Inventory-Short Form (BPI-SF). This scale values are 0 to 10, a lower score means little to no pain while a higher score means greater pain.|Baseline and day 182|Intent-to-treat population: all randomized patients. Participants with observations at baseline and day 182 were included in this analysis.||units on a scale||Standard Deviation|Mean
705980|NCT00103740|Secondary|Change in Pain Severity at Day 182|Change in pain severity score from Brief Pain Inventory-Short Form (BPI-SF). This scale values are 0 to 10, a lower score means little to no pain while a higher score means greater pain.|Baseline and day 182|Intent-to-treat population: all randomized patients. Participants with observations at baseline and day 182 were included in this analysis.||units on a scale||Standard Deviation|Mean
705981|NCT00103740|Secondary|Number of Patients Who Achieved Serum Alkaline Phosphatase Normalization at Day 28|Normalization of serum alkaline phosphatase occurred if the serum alkaline phosphatase measurement fell within the normal range. Central laboratory reference ranges for serum alkaline phosphatase: 31-110 U/L (female & male 20-58 years) and 35-115 U/L (female & male >58 years).|Day 28|Intent-to-treat population: all randomized patients. Participants with observations at day 28 were included in this analysis.||participants|||Number
705982|NCT00103740|Secondary|Time to First Therapeutic Response|Therapeutic response was defined as a reduction of at least 75% from baseline in serum alkaline phosphatase excess (difference between measured level and midpoint to the normal range) or normalization of serum alkaline phosphatase.|182 days|Intent-to-treat population: all randomized patients.||days||Inter-Quartile Range|Median
705983|NCT00103740|Secondary|Relative Change in Urine α-CTx in ug/mmol at Day 10|The percent change in urine α-CTx from baseline to Day 10 was measured.|Baseline and day 10|Intent-to-treat population: all randomized patients. Participants with observations at baseline and day 10 were included in this analysis.||percent change||Standard Deviation|Mean
705984|NCT00103740|Secondary|Relative Change in Serum C-telopeptide (CTx) in ng/mL at Day 10|The percent change in serum C-telopeptide from baseline to Day 10 was measured.|Baseline and day 10|Intent-to-treat population: all randomized patients. Participants with observations at baseline and day 10 were included in this analysis.||percent change||Standard Deviation|Mean
705985|NCT00103740|Secondary|Relative Change in Serum Alkaline Phosphatase in U/L at Day 28|The percent change in serum alkaline phosphatase from baseline to Day 28 was measured.|Baseline and 28 days|Intent-to-treat population: all randomized patients. Participants with observations at baseline and 28 days were included in this analysis.||percent change||Standard Deviation|Mean
705986|NCT00103740|Primary|Number of Patients Who Had Therapeutic Response at 6 Months|A therapeutic response was defined as a reduction of at least 75% from baseline (Visit 1) in serum alkaline phosphatase (SAP) excess (difference between measured level and midpoint to the normal range) or normalization of SAP at the end of six months.|Baseline, 6 months|Modified intent to treat population: all randomized patients with both baseline and at least one post-baseline serum alkaline phosphatase measurement. Missing values at 6 months were imputed using the last post-baseline measurement prior to 6 months.||participants|||Number
705987|NCT00103844|Secondary|Blood Sample Collection for Pharmacokinetic (PK) Analysis of Dasatinib|Number of participants from which blood samples were collected for population PK studies.|Day 8: pretreatment trough sample, a sample between 30 minutes and 3 hours following treatment, a sample between 5 and 8 hours following treatment, and a sample at 12 hours, prior to the next dose.|Blood samples that were to contribute to PK modeling were collected from 78 participants,to be included in separate population PK analyses. Although blood sample collection was listed as a secondary endpoint, no study-specific PK analyses were planned for this report.||participants|||Number
705988|NCT00103844|Secondary|Health-Related Quality of Life Prior to Crossover|Health-related quality of life as measured by Functional Assessment of Cancer Therapy-General (FACT-G). FACT-G=27 questions in 4 domains: physical, social/family, emotional, & functional well-being (PWB, SWB, EWB, FWB). Higher scores=better health-related quality of life. Total Score change of 7 or more=minimal clinical important change; PWB, EWB, & FWB score change of 3 or more, & SWB score change of 2 or more=minimal clinical important change.|Every 4 weeks for the first 24 weeks, then every 12 weeks for the remainder of treatment. Last questionnaire was to be completed at first follow-up visit after off-study date.|Since single-arm quality-of-life data are not interpretable in a non-comparative trial, these data were not analyzed.||Units on a Scale|||Number
705989|NCT00103844|Secondary|Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Hematologic Toxicities Prior to Crossover|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition regardless of causal relationship with treatment. SAE=any untoward medical occurrence at any dose that: results in death; is life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability; is cancer; is congenital anomaly/birth defect; results in drug dependency/abuse; is an important medical event. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death)|Continuously from baseline through 2 years|All treated participants||Participants|||Number
705990|NCT00103844|Secondary|Cytogenetic Response After Crossover|Cytogenetic response was based on the prevalence of Ph+ metaphases among cells in metaphase on a bone marrow sample (aspirate/biopsy). MCyR was defined as Complete CyR (0% Ph+ cells in metaphase in bone marrow) or Partial CyR (>0% to 35% Ph+ cells in metaphase in bone marrow).|every 12 week period out to 2 years and off-study timepoints; restricted to postcrossover measurements|Participants evaluable for after crossover response||Participants|||Number
705991|NCT00103844|Secondary|CHR After Crossover|Participants achieving CHR after crossover. CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets < 450,000/mm³; no blasts or promyelocytes in peripheral blood; < 5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils ≤ 20%; no extramedullary involvement. Confirmed CHR is defined as CHR maintained at least 4 weeks after first documented at ≥ Day 14. Failure to maintain criteria of CHR was defined by 2 or more consecutive records of non-response.|Weekly for 12 weeks, then after every 12 week period out to 2 years; restricted to postcrossover measurements.|Participants evaluable for response after crossover||Participants|||Number
705992|NCT00103844|Secondary|Major Molecular Response (MMR)|Number of participants Achieving MMR. MMR is defined as ≤3 log reduction (ie, international ratio ≤0.1), in BCR-ABL levels from the standardized baseline value of BCR-ABL: Control Gene ratio. The international ratio is obtained by multiplying BCR-ABL: Control gene ratio by the lab-specific conversion factor.|Pretreatment, then after every 4 weeks for 12 weeks, then after every 12 week period out to 2 years; restricted to precrossover measurements.|Participants assessed for MMR only||participants|||Number
705993|NCT00103844|Secondary|Time to CHR Prior to Crossover|Median time from first dosing date to date of CHR. CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets < 450,000/mm³; no blasts or promyelocytes in peripheral blood; < 5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils ≤ 20%; no extramedullary involvement. Confirmed CHR is defined as CHR maintained at least 4 weeks after first documented at ≥ Day 14. Failure to maintain criteria of CHR was defined by 2 or more consecutive records of non-response.|Baseline (within 4 weeks of Day 1), weekly until Week 12, then every 12 weeks until crossover or off-study; restricted to precrossover measurements.|Number of participants achieving CHR in each treatment group||weeks||Full Range|Median
705994|NCT00103844|Secondary|Duration of Complete Hematologic Response (CHR)|Percentage of participants who achieved CHR and did not progress at specified time points. CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets < 450,000/mm³; no blasts or promyelocytes in peripheral blood; < 5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils ≤ 20%; no extramedullary involvement. Confirmed CHR is defined as CHR maintained at least 4 weeks after first documented at ≥ Day 14. Failure to maintain criteria of CHR was defined by 2 or more consecutive records of non-response.|12 months, 24 months|Number of participants achieving CHR in each treatment group||percentage of participants|||Number
705995|NCT00103844|Secondary|Complete Hematologic Response (CHR) at Any Time Prior to Crossover|Participants achieving CHR prior to crossover. CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets < 450,000/mm³; no blasts or promyelocytes in peripheral blood; < 5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils ≤ 20%; no extramedullary involvement. Confirmed CHR is defined as CHR maintained at least 4 weeks after first documented at ≥ Day 14. Failure to maintain criteria of CHR was defined by 2 or more consecutive records of non-response.|Baseline (within 4 weeks of Day 1), weekly until Week 12 and then every 12 weeks until crossover or off-study; restricted to precrossover measurements.|||Participants|||Number
705996|NCT00103844|Secondary|Time to MCyR Prior to Crossover|Median time from first dosing date to date of MCyR|Baseline (within 4 weeks of Day 1), every 12 weeks, at crossover or off-study timepoints; restricted to precrossover measurements.|Population consists of the number of responders in each treatment group||months||Full Range|Median
705997|NCT00103844|Secondary|Duration of MCyR at 24 Months|Percentage of participants who achieved MCyR and did not progress at 24 months.|24 Months|In the imatinib group, the 24 months timepoint was beyond the maximum observed time.||Percentage of Participants|||Number
705998|NCT00103844|Secondary|Duration of MCyR at 12 Months and 18 Months|Percentage of participants who achieved MCyR and did not progress at 12 and 18 months.|12 months, 18 months|||percentage of participants.|||Number
705999|NCT00103844|Secondary|MCyR at Any Time Prior to Crossover|Cytogenetic response was based on the prevalence of Ph+ metaphases among cells in metaphase on a bone marrow sample (aspirate/biopsy). MCyR was defined as CCyR (0% Ph+ cells in metaphase in bone marrow) or PCyR (>0% to 35% Ph+ cells in metaphase in bone marrow).|Baseline (within 4 weeks of Day 1), every 12 weeks until crossover or off-study timepoints. Restricted to precrossover measurements.|||Participants|||Number
706000|NCT00103844|Primary|Number of Participants With Major Cytogenetic Response (MCyR) at Week 12|Cytogenetic response was based on the prevalence of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase on a bone marrow sample (aspirate/biopsy). MCyR was defined as Complete CyR (CCyR; 0% Ph+ cells in metaphase in bone marrow) or Partial CyR (PCyR; >0% to 35% Ph+ cells in metaphase in bone marrow).|Week 12|All randomized subjects||Participants|||Number
706001|NCT00103857|Secondary|Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 104|Change from baseline at Week 104 is defined as Week 104 minus Week 0.|Week 104|The Extension Full Analysis Set (EFAS) included all patients with a baseline value and ≥1 value in the extension (post-Week 54) for this outcome. Data following glycemic rescue were treated as missing. For EFAS patients with no data at Week 104, the last observed measurement was carried forward.||mg/dL||95% Confidence Interval|Least Squares Mean
706002|NCT00103857|Secondary|Change From Baseline in FPG (Fasting Plasma Glucose) at Week 104|Change from baseline at Week 104 is defined as Week 104 minus Week 0.|Week 104|The Extension Full Analysis Set (EFAS) included all patients with a baseline value and ≥1 value in the extension (post-Week 54) for this outcome. Data following glycemic rescue were treated as missing. For EFAS patients with no data at Week 104, the last observed measurement was carried forward.||mg/dL||95% Confidence Interval|Least Squares Mean
706057|NCT00104572|Primary|Effect of Testosterone Gel vs. Anastrozole on Bone Mineral Density|bone mineral density lumbar spine|1 year|||g/cm2||Standard Deviation|Mean
706058|NCT00104637|Secondary|O2 Saturation at Peak Exercise|O2 Saturation at Peak Exercise measured during the Cardiopulmonary exercise test.|Period 1 and Period 3 ( within 8 weeks)|||percentage of oxygen saturation||95% Confidence Interval|Least Squares Mean
706003|NCT00103857|Secondary|Change From Baseline in HbA1c (Hemoglobin A1C) at Week 104|HbA1c is measured as a percent. This change from baseline reflects the Week 104 HbA1c percent minus the Week 0 HbA1c percent.|Week 104|The Extension Full Analysis Set (EFAS) included all patients with a baseline value and ≥1 value in the extension (post-Week 54) for this outcome. Data following glycemic rescue were treated as missing. For EFAS patients with no data at Week 104, the last observed measurement was carried forward.||Percent||95% Confidence Interval|Least Squares Mean
706004|NCT00103857|Secondary|Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 54|Change from baseline at Week 54 is defined as Week 54 minus Week 0.|Week 54|The Phase B Full Analysis Set (BFAS) included all patients with a baseline value and ≥1 value in Phase B (post-Week 24) for this outcome. Data following glycemic rescue were treated as missing. For BFAS patients with no data at Week 54, the last observed measurement was carried forward to Week 54.||mg/dL||95% Confidence Interval|Least Squares Mean
706005|NCT00103857|Secondary|Change From Baseline in FPG (Fasting Plasma Glucose) at Week 54|Change from baseline at Week 54 is defined as Week 54 minus Week 0.|Week 54|The Phase B Full Analysis Set (BFAS) included all patients with a baseline value and ≥1 value in Phase B (post-Week 24) for this outcome. Data following glycemic rescue were treated as missing. For BFAS patients with no data at Week 54, the last observed measurement was carried forward to Week 54.||mg/dL||95% Confidence Interval|Least Squares Mean
706006|NCT00103857|Secondary|Change From Baseline in HbA1c (Hemoglobin A1C) at Week 54|HbA1c is measured as a percent. This change from baseline reflects the Week 54 HbA1c percent minus the Week 0 HbA1c percent.|Week 54|The Phase B Full Analysis Set (BFAS) included all patients with a baseline value and ≥1 value in Phase B (post-Week 24) for this outcome. Data following glycemic rescue were treated as missing. For BFAS patients with no data at Week 54, the last observed measurement was carried forward to Week 54.||Percent||95% Confidence Interval|Least Squares Mean
706007|NCT00103857|Secondary|Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 24|Change from baseline at Week 24 is defined as Week 24 minus Week 0.|Week 24|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last observed measurement was carried forward to Week 24. The Open-label Cohort group was excluded from the FAS.||mg/dL||95% Confidence Interval|Least Squares Mean
706008|NCT00103857|Secondary|Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24|Change from baseline at Week 24 is defined as Week 24 minus Week 0.|Week 24|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last observed measurement was carried forward to Week 24. The Open-label Cohort group was excluded from the FAS.||mg/dL||95% Confidence Interval|Least Squares Mean
706009|NCT00103857|Primary|Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24|HbA1c is measured as a percent. This change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent.|Week 24|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last observed measurement was carried forward to Week 24. The Open-label Cohort group was excluded from the FAS.||Percent||95% Confidence Interval|Least Squares Mean
706010|NCT00104052|Primary|Number of Participants With a Sustained Virologic Response (SVR) at 24 Weeks Post-treatment|SVR is defined as undetectable hepatitis C virus ribonucleic acid (HCV-RNA) at 24 weeks post-treatment|Up to 48-week treatment duration. Follow-up of 24 weeks.|Carry Forward analysis of participants who received at least one dose of study medication. This dataset includes one subject with undetectable HCV-RNA at Follow-up Week 12 (FW 12) but missing data at FW 24; this subject was considered a sustained responder in the Carry Forward analysis.||Participants|||Number
706011|NCT00104104|Primary|The Number of Participants With Disease Progression||24 Months|Safety Population; enrolled patients who received at least one dose of study medication.||Participants|||Number
706012|NCT00104104|Secondary|Zoledronic Acid Concentrations|Samples for drug concentration analysis were drawn at 10 and 15 minutes into the infusion for participants in the 15-minute infusion group and at 25 and 30 minutes into the infusion for patients in the 30-minute infusion group. The mean and median zoledronic acid concentrations were greater in the 15-minute group than in the 30-minute group at both sampling timepoints.|24 months|The pharmacokinetic (PK) population was analyzed for zoledronic acid concentration. Participants were considered to be in the PK population if they had evaluable PK data.||ng/mL||Standard Deviation|Mean
706013|NCT00104104|Secondary|Time to First Significant Increase in Serum Creatinine|Median time to event in participants who had a clinically relevant increase in serum creatinine.|Up to 24 months|Safety Population; enrolled patients who received at least one dose of study medication. The medians shown are only for patients who had a significant increase by 24 months.||weeks||Full Range|Median
706014|NCT00104104|Secondary|The Number of Participants With a Significant Increase in Serum Creatinine at 24 Months|Serum Creatinine was considered to be significantly increased if there was an increase of 0.5 mg/dL or more or a doubling of the baseline serum creatinine value.|Baseline and 24 Months|Safety Population; enrolled patients who received at least one dose of study medication.||Participants|||Number
706015|NCT00104104|Primary|The Number of Participants With a Significant Increase in Serum Creatinine at 12 Months|The primary renal safety endpoint was the number of participants with a clinically relevant increase in serum creatinine at 12 months. Serum creatinine was determined prior to each zoledronic acid infusion for all Participants and was considered to be significantly increased if there was an increase of 0.5 mg/dL or more or a doubling of the baseline serum creatinine value.|Baseline and 12 Months|Safety Population: enrolled patients who received at least one dose of study medication, exluding site 74.||Participants|||Number
706016|NCT00104234|Secondary|Change in Urinary Glycosaminoglycans (GAG) Level|Mean change in urinary GAG level for the first 72 weeks of rhASB treatment. For the rhASB/rhASB group, mean change was calculated for Week 72 -Baseline. For the placebo/rhASB, mean change was calculated for Week 96 - Week 24.|72 weeks|rhASB/rhASB and placebo/rhASB groups were combined for the analysis, representing 72 weeks of rhASB treatment in each group.||microgram/mg creatinine||Standard Deviation|Mean
706059|NCT00104637|Secondary|Oxygen Pulse|Oxygen pulse during Cardiopulmonary exercise test at peak exercise.|Period 1 and Period 3 ( within 8 weeks)|||ml/beat||95% Confidence Interval|Least Squares Mean
706017|NCT00104234|Secondary|3-Minute Stair Climb|Mean change in number of stairs climbed per minute in 3 minutes. Mean change is the mean difference between the 3-Minute Stair Climb at 96 weeks and that measured before first ever treatment with rhASB. Mean change is calculated for Week 96 – Baseline for the rhASB/rhASB group and for Week 96 – Week 24 for the placebo/rhASB group.|Baseline ASB-03-05 through week 96 of ASB-03-06.|The efficacy analysis included all subjects who continued in the extension study (ASB-03-06) except 1 subject from the placebo/rhASB group who missed the Week 96 measurement.||stairs/min||Standard Deviation|Mean
706018|NCT00104234|Primary|12-Minute Walk Test|Mean change in meters walked in 12 minutes. Mean change is the mean difference between the 12-Minute Walk Test at 96 weeks and that measured before first ever treatment with rhASB. For the rhASB/rhASB group, mean change is calculated for Week 96 – Baseline. For the placebo/rhASB group, mean change is calculated for Week 96 – Week 24.|Baseline of ASB-03-05 through week 96 of ASB-03-06|The efficacy analysis included all subjects who continued in the extension study (ASB-03-06) except the 1 subject from the rhASB/rhASB group and 1 subject from the placebo/rhASB group who missed the Week 96 measurement.||meters||Standard Deviation|Mean
706019|NCT00104247|Primary|Change in Blood Phenylalanine Levels From Baseline to Week 6.||baseline to week 6|||micromole per liter||Standard Deviation|Mean
706020|NCT00104299|Post-Hoc|Number of Subjects Experiencing Serious Adverse Events|Number of subjects according to originally received treatment that experienced a serious adverse event through 18 months post-randomization or prior to being censored from analyses due to crossover, switching to open-label treatment, or best medical judgment for censor. Events are categorized by coded system organ classes (SOC). Within each SOC, a participant was counted once if the participant reported one or more events coded to that SOC.|Randomization to censor at Crossover, Open-label or Best Medical Judgment (up to 18 months post-randomization)|Intent-to-treat||participants|||Number
706021|NCT00104299|Secondary|Time to Complete Remission (BVAS=0, Off Glucocorticoids) From the Visit 1 Baseline Visit in the Two Treatment Groups|"Time to complete remission is defined as the number of days from baseline visit (Visit 1) to a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG)[1] of 0 and completing taper of glucocorticoid by 6 months post-randomization.
[1] The BVAS/WG is a disease activity index designed to document new or worsening clinically active vasculitis consisting of items divided into 9 organ based systems. BVAS/WG scores range from 0 to 63, with higher scores indicating more active disease"|18 months post-randomization|Intent-to-treat||Days||95% Confidence Interval|Number
706022|NCT00104299|Secondary|Time to Remission (BVAS=0) From the Visit 1 Baseline Visit in the Two Treatment Groups|"Time to complete remission is defined as the number of days from baseline visit (Visit 1) to a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG)[1] of 0.
[1] The BVAS/WG is a disease activity index designed to document new or worsening clinically active vasculitis consisting of items divided into 9 organ based systems. BVAS/WG scores range from 0 to 63, with higher scores indicating more active disease"|18 months post-randomization|Intent-to-treat||Days||95% Confidence Interval|Number
706023|NCT00104299|Secondary|The Duration of Remission (BVAS=0), the Time to Limited and/or Severe Flare After Remission in the Two Treatment Groups|Duration of remission is defined as a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG)[1] of 0 and a completing taper of glucocorticoid by 6 months post-randomization to the first flare, BVAS/WG score of greater than 0, or an increase in Prednisone dosing.|18 months post-randomization|Intent-to-treat||Days||95% Confidence Interval|Number
706024|NCT00104299|Secondary|The Duration of Complete Remission (BVAS=0, Off Glucocorticoids), the Time to Limited and/or Severe Flare After Remission in the Two Treatment Groups|"Duration of complete remission is defined as a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG)[1] of 0 and a completing taper of Prednisone to the first flare, BVAS/WG score of greater than 0, or an increase in Prednisone dosing.
[1] The BVAS/WG is a disease activity index designed to document new or worsening clinically active vasculitis consisting of items divided into 9 organ based systems. BVAS/WG scores range from 0 to 63, with higher scores indicating more active disease"|18 months post-randomization|Intent-to-treat||Days||95% Confidence Interval|Number
706025|NCT00104299|Secondary|Percentage of Participants Who Have a BVAS/WG Score of 0 and Have Successfully Completed the Glucocorticoid Taper by 6 Months Post-randomization|"The 2-sided 95% CI of the percentage of participants who have a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG)[1] of 0 and have successfully completed the glucocorticoid taper by 6 months post-randomization and the 2-sided 95% CI of the difference between two arms for assessing the superiority of rituximab to control
[1] The BVAS/WG is a disease activity index designed to document new or worsening clinically active vasculitis consisting of items divided into 9 organ based systems. BVAS/WG scores range from 0 to 63, with higher scores indicating more active disease"|6 months post-randomization|Safety Sample||participants|||Number
706026|NCT00104299|Secondary|Rate of Selected Adverse Events Experienced by Participants Receiving Rituximab Versus Those Receiving Conventional Therapy|The adverse event rate for the following events considered related to vasculitis: Death; Grade 2 or higher leukopenia or thrombocytopenia; Grade 3 or higher infections; Hemorrhagic cystitis (grade 2 or lower needs confirmation by cytoscopy); Malignancy; Venous thromboembolic event (deep venous thrombosis or pulmonary embolism); Hospitalization resulting either from the disease or from a complication due to study treatment; Infusion reactions (within 24 hours of infusion) that result in the cessation of further infusions (including cytokine release allergic reaction); Cerebrovascular accident|Through common close-out (defined as 18 months after the last participant is enrolled in the trial)|Safety Sample||participants|||Number
706027|NCT00104299|Primary|Disease Remission|A Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG) score of 0 with prednisone taper successfully completed at six months. The BVAS/WG is a validated disease activity index. The BVAS/WG is designed to document new or worsening clinically active vasculitis and consists of a set of items divided into nine organ based systems. BVAS/WG scores range from 0 to 63, with higher scores indicating more active disease.|6 months post-randomization|Intent-to-treat (ITT) sample with worst case imputation||Participants|||Number
706060|NCT00104637|Secondary|A-a Gradient (Alveolar-arterial Gradient)|A-a gradient was measured with ABG breathing room air at rest.|Period 1 and Period 3 ( within 8 weeks)|||mm Hg||95% Confidence Interval|Least Squares Mean
706061|NCT00104637|Secondary|Partial Pressure of Oxygen (PO2) in Arterial Blood Gas (ABG)|Partial Pressure of Oxygen in ABG breathing room air at rest.|Period 1 and Period 3 ( within 8 weeks)|||mm Hg||95% Confidence Interval|Least Squares Mean
706028|NCT00104416|Secondary|Serum Concentrations and Population (POP) Pharmacokinetic Parameters for Lamotrigine|Serum samples for participants on lamotrigine were analyzed with a validated analytical method based on solid phase extraction of serum followed by High-Performance Liquid Chromatography (HPLC) Mass Spectrometry (MS)/MS analysis. The lower limit of quantification (LLQ) for serum lamotrigine was 4 nanograms (ng)/milliliter (mL), using a 50 microliter (µL) aliquot of human serum with a higher limit of quantification (HLQ) of 4,000 ng/mL. PK data cannot be reported, as PK data from several different studies have been combined into one POP/PK analysis and cannot be separated by study.|Blood samples drawn at Treatment Weeks 11, 15, and 19 (or last on-study measurement in Double-Blind Treatment Phase)|PK Population: Number of participants analyzed for PK data cannot be reported, as PK data from several different studies have been combined into one POP/PK analysis and cannot be separated by study.|||||
706029|NCT00104416|Secondary|Mean Change From Baseline in the Epworth Sleepiness Scale (ESS) 8-Item Total Score at Week 19 of the Double-Blind Treatment Phase|The ESS is an 8-item, self-administered questionnaire that measures excessive daytime sleepiness in adults. The instrument captures information on the extent to which the participant would be likely, or not, to fall asleep in certain situations. The stimulus question is: How likely are you to doze off or fall asleep in the following situations, in contrast to feeling just tired? Questions are answered on a 4-point scale (would never doze [0] to high chance of dozing [3]). The total score ranges from 0 to 24, where a higher score indicates a higher chance of dozing.|Baseline and Week 19 (or last on-study measurement in Double-Blind Treatment Phase)|ITT Population. The questionnaire was not completed by 55 and 51 participants in the Placebo and LTG XR groups, respectively. Only participants completing the questionnaire were included in the analysis of this outcome measure.||points on a scale||Standard Error|Least Squares Mean
706030|NCT00104416|Secondary|Mean Change From Baseline in the Seizure Severity Questionnaire (SSQ) Global Bother Score at Week 19 Double-Blind Treatment Phase|The SSQ is a self-reported instrument developed to assess the severity of seizures and seizure symptoms. The scale consists of 10 major clinical features/symptoms of seizures that the participants rate on a 7-point Likert scale (ranging from very mild/helpful/no bother at all [1] to very severe/no help/bothersome [7]). The Global Bother Domain is the primary score used for the analysis of the SSQ and has scores ranging from 1 to 7.|Baseline and Week 19 (or last on-study measurement in Double-Blind Treatment Phase)|ITT Population. The questionnaire was not completed by 68 and 67 participants in the Placebo and LTG XR groups, respectively. Only participants completing the questionnaire were included in the analysis of this outcome measure.||points on a scale||Standard Error|Least Squares Mean
706031|NCT00104416|Secondary|Mean Change From Baseline in the Adverse Experience Profile (AEP) Total Score at Week 19 of the Double-Blind Treatment Phase|The AEP is a list of 19 items covering many possible side effects attributable to drug treatment. The participants respond by assessing how much each event has been a problem for them over the past 4 weeks (1=Never a Problem to 4=Always a Problem). Each individual item can be examined; an overall adverse events score is calculated as the sum of the scores across the 19 items. The AEP total score ranges from 19 to 76, with a higher score indicating a higher degree of adverse event severity.|Baseline and Week 19 (or last on-study measurement in Double-Blind Treatment Phase)|ITT Population. The questionnaire was not completed by 65 participants in both the Placebo and LTG XR groups. Only participants completing the questionnaire were included in the analysis of this outcome measure.||points on a scale||Standard Error|Least Squares Mean
706032|NCT00104416|Secondary|Mean Change From Baseline in the Quality of Life in Epilepsy-31-P (QOLIE-31P) Overall Score at Week 19 of the Double-Blind Treatment Phase|The QOLIE-31 is a 31-item questionnaire that evaluates the participants' perception of his or her quality of life in 7 domains: seizure worry, emotional well being, energy/fatigue, cognitive functioning, medication effects, social functioning, and overall quality of life. Each domain (with scores ranging from 0 to 100) is summed and divided by the total number of questions that were answered. The overall score is derived by weighting and then summing up the seven domain scores.|Baseline and Week 19 (or last on-study measurement in Double-Blind Treatment Phase)|ITT Population. The questionnaire was not completed by 55 participants in both the Placebo and LTG XR groups. Only participants completing the questionnaire were included in the analysis of this outcome measure.||points on a scale||Standard Error|Least Squares Mean
706033|NCT00104416|Secondary|Mean Change From Baseline in the Neurological Disorders Depression Inventory-Epilepsy (NDDI-E) 6-Item Total Score at Week 19 of the Double-Blind Treatment Phase|The NDDI-E is a self-reported questionnaire composed of 46 brief phrases/words to identify mood disorders across the spectrum of depression. It was developed to capture depressive moods that are co-morbid with the disease of epilepsy or its treatment as well as to measure the depressive state of the participant. All phrases are measured on a 4-point Likert scale of Never (1) to Always/often (4) and refer to the participants’ mood over the past week. Scoring is comprised of a total mood score calculated by summing the scores of 6 specific items (from 6=never to 24=always or often).|Baseline and Week 19 (or last on-study measurement in Double-Blind Treatment Phase)|ITT Population. The questionnaire was not completed by 65 participants in both the Placebo and LTG XR groups. Only participants completing the questionnaire were included in the analysis of this outcome measure.||points on a scale||Standard Error|Least Squares Mean
706034|NCT00104416|Secondary|Mean Change From Baseline in the Center for Epidemiological Studies-Depression Scale (CES-D) Total Score at Week 19 of the Double-Blind Treatment Phase|The 20-item CES-D questionnaire is self-administered and asks respondents to report the frequency to which the 20 events were experienced over the past week. A 4-point Likert scale is used and ranges from rarely or none of the time (0) to most or all of the time (3). The total score, a sum across the 20 items (ranging from 0 to 60), determines the extent to which a participant may be experiencing depression. Higher scores indicate a higher severity of depression.|Baseline and Week 19 (or last on-study measurement in Double-Blind Treatment Phase)|ITT Population. The questionnaire was not completed by 64 and 59 participants in the Placebo and LTG XR groups, respectively. Only participants completing the questionnaire were included in the analysis of this outcome measure.||points on a scale||Standard Error|Least Squares Mean
706062|NCT00104637|Secondary|Partial Pressure of Carbon Dioxide (PCO2) in Arterial Blood Gas (ABG)|Partial pressure of carbon dioxide in ABG performed breathing room air at rest.|Period 1 and Period 3 ( within 8 weeks)|||mm Hg||95% Confidence Interval|Least Squares Mean
706063|NCT00104637|Secondary|Diffusing Capacity of Carbon Monoxide (DLCO)|Carbon Monoxide Diffusing Capacity was measured on the same days as the pulmonary function tests.|Period 1 and Period 3 ( within 8 weeks)|||ml/min/torr||95% Confidence Interval|Least Squares Mean
706035|NCT00104416|Secondary|Mean Change From Baseline in the Profile of Mood State (POMS) Mood Disturbance Total Score at Week 19 of the Double-Blind Treatment Phase|The POMS is a self-administered 65-item questionnaire that evaluates the participants' perception of their mood state in 6 areas: tension-anxiety, depression-dejection, anger-hostility, vigor-activity, fatigue-inertia, and confusion-bewilderment. Items are rated on a 5-point Likert scale from 0 (not at all) to 4 (extremely), with higher scores indicating a more negative mood state. A total score (from 0 to 24) is obtained by summing the scores of the six domains.|Baseline and Week 19 (or last on-study measurement in Double-Blind Treatment Phase)|ITT Population. The questionnaire was not completed by 53 and 57 participants in the Placebo and LTG XR groups, respectively. Only participants completing the questionnaire were included in the analysis of this outcome measure.||points on a scale||Standard Error|Least Squares Mean
706036|NCT00104416|Secondary|Number of Participants With >=25%, >=50%, >=75%, or 100% Reduction or >=50% Increase From Baseline in Weekly PGTC Seizure Frequency for the Entire Continuation Phase, the Transition Phase, the Open-Label (OL) Phase, and the Last 8 Weeks of the OL Phase.|Change in seizure frequency was calculated as the average seizure frequency during each of the following: the Entire CP (CP Week 1 up to Week 52); the Transition Phase (CP Week 1 up to Week 7); the Open-Label (OL) Phase (CP Week 8 up to Week 52); and the last 8 weeks of the Open Label Phase (CP Week 45 up to Week 52) minus the seizure frequency at Baseline. W, Week.|Entire CP (CP Week 1 up to Week 52), the Transition Phase (CP Week 1 up to Week 7), the Open-Label Phase (CP Week 8 up to Week 52), and the last 8 weeks of the Open-Label Phase (CP Week 45 up to Week 52)|ITT Population for CP. Variability in participant numbers are due to not having any PGTC seizures during the Baseline Phase and study withdrawal prior to progressing to the next phase.||participants|||Number
706037|NCT00104416|Secondary|Percent Change From Baseline in Weekly PGTC Seizure Frequency During the Entire Continuation Phase (CP), the Transition Phase, the Open-Label Phase, and the Last 8 Weeks of the Open-Label Phase|Percent change from baseline is calculated as the number of seizures by week during the entire CP (CP Week 1 up to Week 52), the Transition Phase (CP Week 1 up to Week 7), the Open-Label Phase (CP Week 8 up to Week 52), and the last 8 weeks of the Open-Label Phase (CP Week 45 up to Week 52) minus the number of seizures per week during the Baseline Phase (Baseline Week 1 through Week 8). A positive number equals a reduction in seizure frequency.|Entire CP (CP Week 1 up to Week 52), the Transition Phase (CP Week 1 up to Week 7), the Open-Label Phase (CP Week 8 up to Week 52), and the last 8 weeks of the Open-Label Phase (CP Week 45 up to Week 52)|ITT Population for CP: all participants who took at least one dose of study medication during the CP and had at least one post baseline seizure assessment during the CP. Variability in participant numbers are due to not having any PGTC seizures during the Baseline Phase and study withdrawal prior to progressing to the next phase.||percent change||Full Range|Median
706038|NCT00104416|Secondary|Number of Participants With Improved Satisfaction With Seizure Control on the Subject Satisfaction Questionnaire in the Double-Blind Treatment Phase|Participants were asked to rate their satisfaction with their seizure control compared to their seizure control prior to initiating study drug on a 7 point scale: marked deterioration (1), moderate deterioration (2), mild deterioration (3), no change (4), mild improvement (5), moderate improvement (6), or marked improvement (7).|Week 19 (or last on-study assessment in Double-Blind Treatment Phase)|ITT Population. Participant satisfaction was not assessed for 2 participants in each of the Placebo and LTG XR groups, respectively.||participants|||Number
706039|NCT00104416|Secondary|Number of Participants With Improved Clinical Status on the Investigator’s Global Assessment in the Double-Blind Treatment Phase|The investigators rated the participants’ overall clinical status based on 7 clinical factors and an overall factor: seizure frequency, duration, and intensity; adverse experiences; social, intellectual, and motor functioning. Using a 7-point scale (marked deterioration [1], moderate deterioration [2], mild deterioration [3], no change [4], mild improvement [5], moderate improvement [6], or marked improvement [7]), the investigators assessed the participants’ status compared to their condition prior to initiating study medication.|Week 19 (or last on-study assessment in Double-Blind Treatment Phase)|ITT Population. Overall clinical status not assessed for 2 participants in each of the Placebo and LTG XR groups, respectively.||participants|||Number
706040|NCT00104416|Secondary|Change From Baseline in Body Weight at Week 19 of the Double-Blind Treatment Phase|Change from baseline in body weight is calculated as the Week 19 (or last on-study measurement in Double-Blind Treatment Phase) value minus the Baseline value.|Baseline and Week 19 (or last on-study measurement in Double-Blind Treatment Phase)|ITT Population||kilograms||Full Range|Median
706041|NCT00104416|Secondary|Number of Participants With the Indicated Time to >=50% Reduction in Seizure Frequency in the Double-Blind Treatment Phase|50% reduction in seizure frequency is defined as the time at which a participant first achieved and maintained a >=50% reduction in seizure frequency following exposure to at least 1 week of study drug.|Baseline through end of Double-Blind Treatment Phase (up to Week 19)|ITT Population||participants|||Number
706042|NCT00104416|Secondary|Percent Change From Baseline in PGTC Seizure Frequency During the Escalation Phase, the Maintenance Phase, and During the Last 8 Weeks of the Maintenance Phase of the Double-Blind Treatment Phase|Percent change from baseline is calculated as the number of seizures by week during the Escalation Phase (Treatment Week 1 up to Week 7), the Maintenance Phase (Treatment Week 8 up to Week 19), and during the last 8 weeks of the Maintenance Phase (Treatment Week 12 up to Week 19) compared to the number of seizures per week during the Baseline Phase (Baseline Week 1 up to Week 8). A positive number equals a reduction in seizure frequency.|Escalation Phase (Treatment Week 1 up to Week 7), Maintenance Phase (Treatment Week 8 up to Week 19), and the last 8 weeks of the Maintenance Phase (Week 12 up to Week 19)|ITT Population. One participant in each treatment group did not have any PGTC seizures during the Baseline Phase as a result they were not counted for this efficacy endpoint; an additional 2 and 1 participants in the Placebo and LTG XR group, respectively, were not counted in the Maintenance Phase (MP) or last 8 weeks of MP due to study withdrawal.||percent change||Full Range|Median
706064|NCT00104637|Secondary|Borg Dyspnea(Scale That Measures Breathlessness) Score at Finish of 6 Minute Walk Test (6MWT)|Participants were asked to scale the breathlessness felt at the end of 6MWT from 0 to 10, with 0 being the least discomfort and 10 being the most discomfort in breathing.|Period 1 and Period 3 ( within 8 weeks)|||Scores on a scale||95% Confidence Interval|Least Squares Mean
706065|NCT00104637|Secondary|Forced Expiratory Volume in the First Second (FEV1 )|The volume of air exhaled in the first second. Data to calculate results for FEV1 was based on Period 1 only.|Period 1 ( 4 weeks)|||liters||95% Confidence Interval|Least Squares Mean
706043|NCT00104416|Secondary|Number of Participants With >=25%, >=50%, >=75%, or 100% Reduction in PGTC Seizure Frequency During the Entire Double-Blind (DB)Treatment Phase (TP), the Escalation Phase, the Maintenance Phase, and the Last 8 Weeks of the Maintenance Phase|Change in seizure frequency was calculated as the average seizure frequency during each of the following: the Entire DB Treatment Phase (Treatment Week 1 up to Week 19); the Escalation Phase (Treatment Week 1 up to Week 7); the Maintenance Phase (Treatment Week 8 up to Week 19); and the last 8 weeks of the Maintenance Phase (Treatment Week 12 up to Week 19), minus the seizure frequency at Baseline.|Entire DB Treatment Phase (Treatment Week 1 up to Week 19), Escalation Phase (Treatment Week 1 up to Week 7), Maintenance Phase (Treatment Week 8 up to Week 19), and the last 8 weeks of the Maintenance Phase (Treatment Week 12 up to Week 19)|ITT Population. One participant in each treatment group did not have any PGTC seizures during the Baseline Phase, as a result they were not counted in this efficacy endpoint; an additional 2 and 1 participants in the Placebo and LTG XR group, respectively, were not counted in the Maintenance Phase (MP) or last 8 weeks of MP due to study withdrawal.||participants|||Number
706044|NCT00104416|Primary|Percent Change From Baseline in Weekly Primary Generalized Tonic-clonic (PGTC) Seizure Frequency During the Entire Double-Blind Treatment Phase|Percent change from baseline is calculated as the number of seizures by week during the Double-Blind Treatment Phase (Treatment Week 1 up to Week 19) compared to the number of seizures per week during the Baseline Phase (Baseline Week 1 up to Week 8). A positive number equals a reduction in seizure frequency. PGTC seizures are more commonly known as gran mal seizures.|Baseline through end of Double-Blind Treatment Phase (up to Week 19)|Intent-to-Treat (ITT) Population: all randomized participants who took at least one dose of study drug and had at least one post-baseline efficacy assessment in the Double-Blind Treatment Phase. One participant in each treatment group did not have any PGTC seizures during the Baseline Phase.||percent change||Full Range|Median
706045|NCT00104520|Other Pre-specified|Minimum Concentration of Aztreonam Inhibiting 50% (MIC50) and 90% (MIC90) of All PA Isolates (μg/mL)|"The aztreonam susceptibility of PA isolates from sputum samples (collected at all visits) was assessed.
MIC50 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 50% of isolates from a particular organism).
MIC90 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 90% of isolates from a particular organism).
MIC50 and MIC90 values are single measurements for the entire population and not measured on a per-participant basis."|Day 0 to Day 28|Analysis based on ITT population (all participants who received at least part of one dose of study drug). No imputation methods were used for the analysis.||μg/mL|||Number
706046|NCT00104520|Other Pre-specified|Number of Participants With Other Pathogens|"Sputum samples were collected at all visits for quantitative and qualitative culture for Staphylococcus aureus, Burkholderia cepacia, Stenotrophomonas maltophilia, and Achromobacter xylosoxidans.
Number of participants with other pathogens at baseline and at the end of treatment (28 days) are reported."|Day 0 and Day 28|Analysis based on ITT population (all participants who received at least part of one dose of study drug). No imputation methods were used for the analysis.||Participants|||Number
706047|NCT00104520|Secondary|Change From Baseline in Pseudomonas Aeruginosa (PA) Log10 Colony Forming Units (CFU) Per Gram of Sputum|Sputum samples were collected at all participant visits of the study for analysis of microbiology endpoints. Sputum samples were processed for qualitative and quantitative culture of PA (each morphotype). Due to the skewness of the distribution of CFU data, the data were transformed using the base 10 logarithm, in an attempt to normalize the data and allow for parametric tests, before calculating changes. To account for zero values, 1 was added to each CFU measurement before being transformed. Any CFU data values where PA was not isolated from a valid culture were set to zero.|Day 0 to Day 28|Analysis based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug). No imputation methods were used for the analysis.||Log10 PA CFUs/gram of sputum||Standard Error|Least Squares Mean
706048|NCT00104520|Secondary|Number of Hospitalization Days|Details of all hospitalizations, including the dates of admission and discharge, were recorded on the electronic case report form (eCRF).|Day 0 to Day 84|Analysis based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug). No imputation methods were used for the analysis.||Days||Standard Deviation|Mean
706049|NCT00104520|Secondary|Percent Change in Forced Expiratory Volume in 1 Second (FEV1) (L)|"Spirometry was performed at each visit. FEV1 was recorded according to American Thoracic Society (ATS) guidelines.
FEV1(L) is the measurement of the volume of air (expressed in liters) exhaled in 1 second.
The percent change in this parameter from Day 0 to Day 28 was determined for each treatment group."|Day 0 to Day 28|Analysis based on ITT population (all participants who received at least part of one dose of study drug). Missing baseline data were not imputed. Missing post-baseline data were imputed using worst-case value for participants who withdrew due to an AE or study drug intolerance. For all other missing data, LOCF imputation method was used.||Percent change in FEV1 (L)||Standard Error|Least Squares Mean
706050|NCT00104520|Secondary|Change in Cystic Fibrosis Questionnaire – Revised (CFQ-R) Respiratory Symptoms Scale (RSS) Score|The CFQ-R was administered at Day -28, baseline, Day 14, Day 28, and Day 84 (end of study). The endpoint was change in respiratory symptoms from baseline, assessed with the CFQ-R RSS (range of scores [units]: 0-100; higher scores indicate fewer symptoms).|Day 0 to Day 28|Analysis based on ITT population (all participants randomized to tx who received at least part of one dose of study drug). Missing baseline data were not imputed. Missing post-baseline data were imputed using worst-case value for participants who withdrew due to AE or study drug intolerance. For all other missing data, LOCF method was used.||Units on a scale||Standard Error|Least Squares Mean
706051|NCT00104520|Primary|Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics|The primary endpoint was time to need for a course of inhaled or IV antipseudomonal antibiotics with documented physician assessment of need for antibiotics. Antipseudomonal Antibiotic need was documented based on the presence of at least one of the following four symptoms predictive of pulmonary exacerbation: decreased exercise tolerance, increased cough, increased sputum / chest congestion, decreased appetite, or other.|Day 0 to Day 84 (end of study)|Analysis based on intents to treat (ITT) population (all participants randomized to treatment who received at least part of one dose of study drug).||Days||95% Confidence Interval|Median
706052|NCT00104572|Secondary|Effect of Testosterone Gel vs. Anastrozole on Gait/Balance Assessment|gait measures|1 year||07/2016||||
706053|NCT00104572|Secondary|Effect of Testosterone Gel vs. Anastrozole on Prostate Volume/Prostate Specific Antigen Levels/Urinary Function|rectal ultrasound and blood test|1 year||07/2016||||
706069|NCT00104650|Secondary|Hypercalcemia|Occurrence of hypercalcemia at grade 3 or 4 according to CTCAE v3 criteria|Day 1, week 25|All participants who are randomized to the treatment phase, receive at least one dose of treatment phase investigational product, and have treatment phase baseline measurements of uNTx and at least one treatment phase post-baseline measurement of uNTx.||Participants|||Number
706070|NCT00104650|Secondary|Skeletal Related Events|Skeletal Related Event (SRE), defined as >1 of the following: pathological bone fracture, spinal cord compression, surgery or radiation therapy to bone (including the use of radioisotopes).|Day 1, week 25|All participants exposed to investigational product during the treatment phase.||Participants|||Number
706071|NCT00104650|Secondary|Time to First Skeletal Related Event|Time from study day 1 to first Skeletal Related Event (SRE), defined as >1 of the following: pathological bone fracture, spinal cord compression, surgery or radiation therapy to bone (including the use of radioisotopes).|Day 1, week 25|All participants exposed to investigational product during the treatment phase. Median was not reached in at least 1 treatment arm. In lieu of the median, the number of subject who experienced a skeletal related event is presented.||Participants|||Number
706072|NCT00104650|Secondary|Percent Change of Serum CTX From Baseline to Week 25|Percent change from baseline to week 25 in Type I serum C-Telopeptide (CTX), calculated using ((week 25 value - baseline value) / baseline value ) x 100.|Baseline, week 25|All participants who are randomized to the treatment phase, receive at least one dose of treatment phase investigational product, and have treatment phase baseline measurements of uNTx and at least one treatment phase post-baseline measurement of uNTx and had available data.||Percent change||Standard Deviation|Mean
706073|NCT00104650|Secondary|Duration of Maintaining uNTX (Corrected by Creatinine) < 50nmol/mmol|Time from the 1st occurrence of uNTx below 50 nmol BCE/mmol (corrected by creatinine) to the 1st occurrence of uNTx above 50 nmol BCE/mmol up to week 25. For participants who remained below 50 nmol BCE/mmol, the time is censored at the time of last evaluation of uNTx up to week 25.|Day 1, week 25|Treatment Phase Primary Analysis Subset. Median was not reached in at least 1 treatment arm. In lieu of the median, the number of subject whose uNTX (corrected by creatinine) less than 50nmol/mmol is presented.||Participants|||Number
706074|NCT00104650|Secondary|Time to Reduction of uNTX (Corrected by Creatinine) to <50nmol/mmol|Kaplan-Meier estimate of the median time from enrollment to the 1st occurrence of uNTx below 50 nmol BCE/mmol (corrected by creatinine) up to week 25. For participants whose uNTx does not go below 50 nM BCE/mM creatinine, the time is censored at time of last evaluation of uNTx by week 25.|Day 1, week 25|All participants who are randomized to the treatment phase, receive at least one dose of treatment phase investigational product, and have treatment phase baseline measurements of uNTx and at least one treatment phase post-baseline measurement of uNTx.||Days||Inter-Quartile Range|Median
706075|NCT00104650|Secondary|Percent Change of uNTx (Corrected by Creatinne) From Baseline to Week 25|Percent change from baseline to week 25 urinary N-telopeptide (uNTX) calculated using ((week 25 value - baseline value) / baseline value ) x 100.|Baseline, week 25|All participants who are randomized to the treatment phase, receive at least one dose of treatment phase investigational product, and have treatment phase baseline measurements of uNTx and at least one treatment phase post-baseline measurement of uNTx.||Percent change||Standard Deviation|Mean
706076|NCT00104650|Secondary|uNTx (Corrected by Creatinine) < 50 Nmol/mmol at Week 25|Urinary N-telopeptide (uNTX) corrected by creatinine < 50 nmol/mmol at week 25.|25 weeks|All participants who are randomized to the treatment phase, receive at least one dose of treatment phase investigational product, and have treatment phase baseline measurements of uNTx and at least one treatment phase post-baseline measurement of uNTx.||Participants|||Number
706077|NCT00104650|Primary|uNTx (Corrected by Creatinine) < 50 Nmol/mmol at Week 13|Urinary N-telopeptide (uNTx) corrected by creatinine (uNTx/Cr) < 50 nmol/mmol at week 13.|13 weeks|All participants who are randomized to the treatment phase, receive at least one dose of treatment phase investigational product, and have treatment phase baseline measurements of uNTx and at least one treatment phase post-baseline measurement of uNTx.||Participants|||Number
706078|NCT00104728|Secondary|Frequency of Toxicity Related to Study Treatment|Review of adverse events utilizing Common Toxicity Criteria (CTC) V3. To estimate the safety, tolerability, and feasibility of preoperative ZD1839 in patients with resectable Stage IA/IB, II and selected IIIA NSCLC by evaluating toxicity and operability after preoperative ZD1839.|3 years||||||
706079|NCT00104728|Primary|Overall Response Rate (ORR)|Objective Response Rate according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Investigators planned to use this pilot study of neoadjuvant ZD1839 in patients with resectable NSCLC to specifically correlate molecular parameters to the primary clinical study endpoint clinical response assessed by CT response and PET scan response of the primary tumor.|3 years||||||
706080|NCT00104871|Primary|Participant Tumor Response Assessed by RECIST|Baseline scan and confirmatory scans obtained 6 weeks following initial documentation of objective response using Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): >30% decrease in sum longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Baseline to 12 weeks (minimum of 4 treatment cycles (or 12 weeks))|Two participants were not evaluable for response.||participants|||Number
706081|NCT00104871|Secondary|Progression-free Survival Assessed by RECIST|Progression-free survival (PFS) is measured from the first day of treatment to the first observation of disease progression or death due to any cause. PFS is reported as number of participants who had no disease progression or death for any reason at 6 months following treatment.|At 6 months||||||
706097|NCT00105079|Secondary|Number of Participants Assessed for Adverse Events (AEs)|Detailed information for Adverse Events and Serious Adverse Events will be represented in the SAE/AE section of PRS.|reported up to 28 days after the last dose of study treatment. (Up to 52 weeks)|Safety population included all randomized patients who received at least one dose of study medication||participants|||Number
706135|NCT00105157|Secondary|Number of Patients With Drug-related LAEs at 48 Weeks|Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs|48 weeks|All patients who took study medication and had any laboratory tests performed were included in the analysis.||Participants|||Number
706082|NCT00104871|Primary|Objective Tumor Response Rate Assessed by RECIST|Response Rate calculated as number of participants with Complete or Partial Response divided by total participants. Baseline scan and confirmatory scans obtained 6 weeks following initial documentation of objective response using Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): >30% decrease in sum longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Baseline to 12 weeks|Two participants were not evaluable for response.||participants|||Number
706083|NCT00104884|Primary|Proportion of Patients With Response to Depsipeptide|"Response is evaluated using Solid Tumor Response Criteria (RECIST) and defined as either complete repose (CR) or partial response (PR).
Per RECIST criteria, CR = disappearance of all target and nontarget lesions; PR = at least 30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits."|Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 3 years from study entry, up to 3 years|The study was terminated early due to slow accrual with final accrual of 4 patients. There are no plans to conduct a formal analysis for any outcome measure.||percentage of participants||95% Confidence Interval|Number
706084|NCT00105001|Secondary|Progression-free Survival|"Percentage of patients with progression-free survival, estimated by cumulative incidence methods
Cumulative incidence methods are the standard way to estimate incidence of an endpoint in the presence of competing risks and censoring (ref)” Here is the reference. Gooley TA, Leisenring W, Crowley J, Storer BE: Estimation of failure probabilities in the presence of competing risks: new representations of old estimators. Statistics in Medicine 18:695-706, 1999. PMID 10204198"|At 6 months and then every year thereafter, up to 5 years|||percentage of participants|||Number
706085|NCT00105001|Secondary|Overall Survival|"Percentage of patients surviving, estimated by cumulative incidence methods
Cumulative incidence methods are the standard way to estimate incidence of an endpoint in the presence of competing risks and censoring (ref)” Here is the reference. Gooley TA, Leisenring W, Crowley J, Storer BE: Estimation of failure probabilities in the presence of competing risks: new representations of old estimators. Statistics in Medicine 18:695-706, 1999. PMID 10204198"|At 6 months and then every year thereafter, up to 5 years|||percentage of participants|||Number
706086|NCT00105001|Secondary|Incidence of High-dose Corticosteroid Utilization.|"Percentage of patients utilizing high-dose corticosteroid (as a surrogate marker for reduction of acute GVHD), estimated by cumulative incidence methods.
Cumulative incidence methods are the standard way to estimate incidence of an endpoint in the presence of competing risks and censoring (ref)” Here is the reference. Gooley TA, Leisenring W, Crowley J, Storer BE: Estimation of failure probabilities in the presence of competing risks: new representations of old estimators. Statistics in Medicine 18:695-706, 1999. PMID 10204198"|150 days after transplant|||percentage of participants|||Number
706087|NCT00105001|Secondary|Incidence of Non-relapse Mortality|"Percentage of NRM as estimated by cumulative incidence methods with competing risks.
Cumulative incidence methods are the standard way to estimate incidence of an endpoint in the presence of competing risks and censoring (ref)” Here is the reference. Gooley TA, Leisenring W, Crowley J, Storer BE: Estimation of failure probabilities in the presence of competing risks: new representations of old estimators. Statistics in Medicine 18:695-706, 1999. PMID 10204198"|200 days after transplant|||percentage of participants|||Number
706088|NCT00105001|Primary|Incidence of Grades II-IV Acute GVHD|"Percentage patients with grades II-IV GHVD, estimated by cumulative incidence methods.
Cumulative incidence methods are the standard way to estimate incidence of an endpoint in the presence of competing risks and censoring (ref)” Here is the reference. Gooley TA, Leisenring W, Crowley J, Storer BE: Estimation of failure probabilities in the presence of competing risks: new representations of old estimators. Statistics in Medicine 18:695-706, 1999. PMID 10204198"|150 days after transplant|||percentage of participants|||Number
706089|NCT00105027|Secondary|Adverse Ocular Outcomes||36 months||||||
706090|NCT00105027|Secondary|Changes in Retinal Thickness as Assessed by Stereoscopic Color Fundus Photography and Optical Coherence Tomography||36 months||||||
706091|NCT00105027|Secondary|Changes From Baseline in Best-corrected ETDRS Visual Acuity Score||36 months||||||
706092|NCT00105027|Primary|The Number of Study Participants Experiencing an Improvement by 15 or More Letters From Baseline in Best-corrected ETDRS Visual Acuity Score at the 12-month Visit|Visual acuity testing was done using electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity testing at 3 meters using the Electronic Visual Acuity Tester by a SCORE certified technician. A masked visual acuity examiner with no knowledge of treatment assignments performed visual acuity testing at the 4-month, 12-month, 24-month and 36-month visits. An E-ETDRS visual acuity score of 85 is approximately 20/20, and a score of 20 letters is approximately 20/400. A visual acuity letter score change of 15 is about three lines on a vision chart.|Change from baseline to 12 months|||Participants|||Number
706093|NCT00105066|Post-Hoc|Homa Insulin Sensitivity|Homeostatic Model Assessment of insulin sensitivity|4.5 months|Participants with complete data.||HOMA Score||Standard Deviation|Mean
706094|NCT00105066|Primary|Change in Flow Mediated Dilation (FMD)|to evaluate improvement in endothelial function|Baseline and 4.5 months|Participants with complete data.||percentage change in diameter||Standard Deviation|Mean
706095|NCT00105066|Primary|Change in Arterial Stiffness Compared to Baseline||Baseline and 4.5 months|||meters / second||Standard Deviation|Mean
706096|NCT00105079|Secondary|Number of Patients Who Discontinued Treatment Due to Abnormal Laboratory Parameters|Routine clinical testing, including hematology and standard chemistry panel was performed at all study visits. Laboratory tests for a fasting lipid profile and fasting insulin determination were obtained at baseline, weeks 24 and 48, and the 4-week follow-up visit. The number of participants who discontinued treatment due to an abnormal laboratory result at any visit is reported.|baseline and all study visits (Up to Week 52)|Safety population included all randomized patients who received at least one dose of study medication.||participants|||Number
706133|NCT00105157|Secondary|Number of Patients Discontinued With Drug-related LAEs at 48 Weeks||48 weeks|All patients who took study medication and had any laboratory tests performed were included in the analysis.||Participants|||Number
706098|NCT00105079|Secondary|Change From Baseline in Cluster Differentiation Antigen 4 Positive (CD4+) Lymphocyte Count|Summary statistics for change from baseline in CD4+ lymphocyte count were presented by treatment arm. Change from baseline in CD4+ lymphocyte count was derived as follows: Change from baseline = (CD4+ count at week x) – (CD4+ count at baseline).|Baseline to Week 48|ITT Population. (n) in each of the categories is the number of participants from the ITT population who had data available at that time point.||cells/mm^3||95% Confidence Interval|Median
706099|NCT00105079|Secondary|Change From Baseline in HIV-1 RNA Viral Load|Descriptive statistics for change from baseline in log10 transformed plasma HIV-1 RNA load (copies/mL) were presented by treatment arm. Logarithmic transformation (base 10) was applied to HIV-1 RNA viral load at baseline and at each study visit. Change from baseline in plasma HIV-1 RNA was derived as follows: Change from baseline = Log10 (HIV-1 RNA at week x) – Log10 (HIV-1 RNA at baseline)|Baseline to Week 48|ITT Population. (n) in each of the categories is the number of participants from the ITT population who had data available at that time point.||copies/mL||95% Confidence Interval|Mean
706100|NCT00105079|Secondary|Number of Patients With HIV-1 RNA Viral Load <50 and <400 Copies/mL|"The secondary objectives of the study were to evaluate the safety, adherence, and tolerability of saquinavir/ritonavir BID plus emtricitabine/tenofovir QD versus lopinavir/ritonavir BID plus emtricitabine/tenofovir QD in treatment-naïve HIV-1 infected adults.
Blood samples for HIV-1 RNA viral load measurement were collected at the Week 48 clinic visit. The number of participants with HIV-1 RNA results <50 copies/mL and the number of participants with HIV-1 RNA results <400 copies/mL are reported."|Week 48|Intent-to-Treat Population||participants|||Number
706101|NCT00105079|Primary|Number of Patients With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Viral Load <50 Copies/mL|"The primary objective of this study was to evaluate the efficacy of saquinavir/ritonavir BID plus emtricitabine/tenofovir QD versus lopinavir/ritonavir BID plus emtricitabine/tenofovir QD in treatment-naïve HIV-1 infected adults.
Blood samples for HIV-1 RNA viral load measurement were collected at the Week 48 clinic visit. The number of participants with HIV-1 RNA results <50 copies/mL is reported."|Week 48|intent-to-treat (ITT) Population||participants|||Number
706102|NCT00105157|Secondary|Number of Patients Discontinued With LAEs at 168 Weeks||168 weeks|All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.||Participants|||Number
706103|NCT00105157|Secondary|Number of Patients With Serious Drug-related LAEs at 168 Weeks|Serious LAEs are any LAEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose|168 weeks|All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.||Participants|||Number
706104|NCT00105157|Secondary|Number of Patients With Drug-related LAEs at 168 Weeks|Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs|168 weeks|All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.||Participants|||Number
706105|NCT00105157|Secondary|Number of Patients Discontinued With Drug-related LAEs at 168 Weeks||168 weeks|All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.||Participants|||Number
706106|NCT00105157|Secondary|Number of Patients With Serious LAEs at 168 Weeks|Serious LAEs are any LAEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose|168 weeks|All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.||Participants|||Number
706107|NCT00105157|Secondary|Number of Patients With Laboratory Adverse Experiences (LAEs) at 168 Weeks|A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|168 weeks|All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.||Participants|||Number
706108|NCT00105157|Secondary|Number of Patients That Discontinued With Serious Drug-related CAEs at 168 Weeks||168 weeks|All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.||Participants|||Number
706109|NCT00105157|Secondary|Number of Patients That Discontinued With Serious CAEs at 168 Weeks||168 weeks|All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.||Participants|||Number
706110|NCT00105157|Secondary|Number of Patients That Discontinued With Drug-related CAEs at 168 Weeks||168 weeks|All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.||Participants|||Number
706111|NCT00105157|Secondary|Number of Patients That Discontinued With CAEs at 168 Weeks||168 weeks|All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.||Participants|||Number
706112|NCT00105157|Secondary|Number of Patients That Died by 168 Weeks||168 weeks|All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.||Participants|||Number
706113|NCT00105157|Secondary|Number of Patients With Serious Drug-related CAEs at 168 Weeks|Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose. Drug-related are as assessed by an investigator who is a qualified physician according to his/her best clinical judgment.|168 weeks|All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.||Participants|||Number
706114|NCT00105157|Secondary|Number of Patients With Drug-related CAEs at 168 Weeks|Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs|168 weeks|All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.||Participants|||Number
706115|NCT00105157|Secondary|Number of Patients With Serious CAEs at 168 Weeks|Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose|168 weeks|All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.||Participants|||Number
706116|NCT00105157|Secondary|Number of Patients With Clinical Adverse Experiences (CAEs) at 168 Weeks|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|168 weeks|All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.||Participants|||Number
706117|NCT00105157|Other Pre-specified|Change From Baseline in CD4 Cell Count at Week 168 in Combined Substudies|Mean change from baseline at Week 168 in CD4 Cell Count (cells/mm3) in patients from combined substudies in the double-blind plus open-label phases.|Baseline and Week 168|Analysis population is based on the modified intent to treat (MITT) approach, where patients are included in the treatment group to which they were randomized. Patients who were randomized but never dosed are not included in the analysis.||CD4 Cell Count (cells/mm3)||95% Confidence Interval|Mean
706118|NCT00105157|Other Pre-specified|Change From Baseline in Plasma HIV RNA (log10 Copies/mL) at Week 168 in Combined Substudies|Mean change from baseline at Week 168 in HIV RNA (log10 copies/mL) in patients from combined substudies in the double-blind plus open-label phases.|Baseline and Week 168|Analysis population is based on the modified intent to treat (MITT) approach, where patients are included in the treatment group to which they were randomized. Patients who were randomized but never dosed are not included in the analysis.||HIV RNA (log10 copies/mL)||95% Confidence Interval|Mean
706119|NCT00105157|Post-Hoc|Number of Patients With Virologic Responses at Week 168 in Combined Substudies|Number of patients who achieve HIV RNA <400 copies/mL; HIV RNA level <50 copies/mL at Week 168; or reduction from baseline in HIV RNA (log10 copies/mL) exceeding 1.0 log10 copies/mL at Week 168.|168 weeks|Analysis population is based on the modified intent to treat (MITT) approach, where patients are included in the treatment group to which they were randomized. Patients who were randomized but never dosed are not included in the analysis.||Participants|||Number
706120|NCT00105157|Secondary|Number of Patients Discontinued With Drug-related LAEs at 96 Weeks||96 weeks|"All patients who took study medication and had
any laboratory tests performed were included in the analysis."||Participants|||Number
706121|NCT00105157|Secondary|Number of Patients Discontinued With Laboratory Adverse Experiences (LAEs) at 96 Weeks||96 weeks|All patients who took study medication and had any laboratory tests performed were included in the analysis.||Participants|||Number
706122|NCT00105157|Secondary|Number of Patients With Drug-related LAEs at 96 Weeks|Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs|96 weeks|||Participants|||Number
706123|NCT00105157|Secondary|Number of Patients With Laboratory Adverse Experiences (LAEs) at 96 Weeks|A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|96 weeks|All patients who took study medication and had any laboratory tests performed were included in the analysis.||Participants|||Number
706124|NCT00105157|Secondary|Number of Patients That Discontinued With Serious Drug-related CAEs at 96 Weeks||96 weeks|All patients who took study medication were included in the analysis.||Participants|||Number
706125|NCT00105157|Secondary|Number of Patients That Discontinued With Serious CAEs at 96 Weeks||96 weeks|All patients who took study medication were included in the analysis.||Participants|||Number
706126|NCT00105157|Secondary|Number of Patients That Discontinued With Drug-related CAEs at 96 Weeks||96 weeks|All patients who took study medication were included in the analysis.||Participants|||Number
706127|NCT00105157|Secondary|Number of Patients That Discontinued With CAEs at 96 Weeks||96 weeks|All patients who took study medication were included in the analysis.||Participants|||Number
706128|NCT00105157|Secondary|Number of Patients That Died by 96 Weeks||96 weeks|All patients who took study medication were included in the analysis.||Participants|||Number
706129|NCT00105157|Secondary|Number of Patients With Serious Drug-related CAEs at 96 Weeks|Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose. Drug-related are as assessed by an investigator who is a qualified physician according to his/her best clinical judgment.|96 weeks|All patients who took study medication were included in the analysis.||Participants|||Number
706130|NCT00105157|Secondary|Number of Patients With Drug-related CAEs at 96 Weeks|Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs|96 weeks|All patients who took study medication were included in the analysis.||Participants|||Number
706131|NCT00105157|Secondary|Number of Patients With Serious CAEs at 96 Weeks|Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose|96 weeks|All patients who took study medication were included in the analysis.||Participants|||Number
706132|NCT00105157|Secondary|Number of Patients With Clinical Adverse Experiences (CAEs) at 96 Weeks|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|96 weeks|All patients who took study medication were included in the analysis.||Participants|||Number
706136|NCT00105157|Secondary|Number of Patients With Laboratory Adverse Experiences (LAEs) at 48 Weeks|A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|48 weeks|All patients who took study medication and had any laboratory tests performed were included in the analysis.||Participants|||Number
706137|NCT00105157|Secondary|Number of Patients That Discontinued With Serious Drug-related CAEs at 48 Weeks||48 weeks|All patients who took study medication were included in the analysis.||Participants|||Number
706138|NCT00105157|Secondary|Number of Patients That Discontinued With Serious CAEs at 48 Weeks||48 weeks|All patients who took study medication were included in the analysis.||Participants|||Number
706139|NCT00105157|Secondary|Number of Patients That Discontinued With Drug-related CAEs at 48 Weeks||48 weeks|All patients who took study medication were included in the analysis.||Participants|||Number
706140|NCT00105157|Secondary|Number of Patients That Discontinued With CAEs at 48 Weeks||48 weeks|All patients who took study medication were included in the analysis.||Participants|||Number
706141|NCT00105157|Secondary|Number of Patients That Died by 48 Weeks||48 weeks|All patients who took study medication were included in the analysis.||Participants|||Number
706142|NCT00105157|Secondary|Number of Patients With Serious Drug-related CAEs at 48 Weeks|Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose. Drug-related are as assessed by an investigator who is a qualified physician according to his/her best clinical judgment.|48 weeks|All patients who took study medication were included in the analysis.||Participants|||Number
706143|NCT00105157|Secondary|Number of Patients With Drug-related CAEs at 48 Weeks|Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs|48 weeks|All patients who took study medication were included in the analysis.||Participants|||Number
706144|NCT00105157|Secondary|Number of Patients With Serious CAEs at 48 Weeks|Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose|48 weeks|All patients who took study medication were included in the analysis.||Participants|||Number
706145|NCT00105157|Secondary|Number of Patients With Clinical Adverse Experiences (CAEs) at 48 Weeks|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|48 weeks|All patients who took study medication were included in the analysis.||Participants|||Number
706146|NCT00105157|Secondary|Change From Baseline in CD4 Cell Count at Week 24|Mean change from baseline at Week 24 in CD4 Cell Count (cells/mm3)|Baseline and Week 24|Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 Cell Count (cells/mm3) was carried forward for patients who discontinued assigned therapy due to lack of efficacy.||CD4 Cell Count (cells/mm3)||95% Confidence Interval|Mean
706147|NCT00105157|Secondary|Number of Patients With Virologic Responses at Week 24|Number of patients who achieve HIV RNA <400 copies/mL; HIV RNA level <50 copies/mL at Week 24; or reduction from baseline in HIV RNA (log10 copies/mL) exceeding 1.0 log10 copies/mL at Week 24; at Week 24|24 weeks|All patients who took study medication and had HIV RNA tests performed were included in the analysis.||Participants|||Number
706148|NCT00105157|Primary|Change From Baseline in Plasma HIV RNA (log10 Copies/mL) at Week 24|Mean change from baseline at Week 24 in HIV RNA (log10 copies/mL) in all patients|Baseline and Week 24|Observed mean change from baseline in log10 Plasma HIV RNA for each group was calculated using the conventional imputation (replace HIV RNA <400 copies/mL by 400 copies/mL if signal detected, or 200 copies/mL if signal not detected). Missing values: baseline-carry-forward for all failures or discontinued due to lack of efficacy||HIV RNA (log10 copies/mL)||95% Confidence Interval|Mean
706149|NCT00105183|Secondary|Pulmonary Function Test, Forced Expiratory Flow 25-75||12 months|Pulmonary Function Tests (PFTs) are reported for all participants of the ITT population, who were alive at 12 months after transplantation and for whom PFT results were reported for the 12-month visit||Liters/second||Full Range|Median
706150|NCT00105183|Secondary|Pulmonary Function Test, Forced Expiratory Volume in 1 Second||12 months|Pulmonary Function Tests (PFTs) are reported for all participants of the ITT population, who were alive at 12 months after transplantation and for whom PFT results were reported for the 12-month visit||Liters||Full Range|Median
706151|NCT00105183|Secondary|Pulmonary Function Test, Forced Vital Capacity||12 months|Pulmonary Function Tests (PFTs) are reported for all participants of the ITT population, who were alive at 12 months after transplantation and for whom PFT results were reported for the 12-month visit||Liters||Full Range|Median
706152|NCT00105183|Secondary|Pulmonary Function Tests, Total Distance Walked 6 Minute Walk Test||12 months|Pulmonary Function Tests (PFTs) are reported for all participants of the ITT population, who were alive at 12 months after transplantation and for whom PFT results were reported for the 12-month visit||Meters||Full Range|Median
706153|NCT00105183|Secondary|Number of Participants With Severe Adverse Events||12 months|Safety population||participants|||Number
706154|NCT00105183|Secondary|Number of Participants With Infections and Infestations||12 months|Safety population||participants|||Number
706155|NCT00105183|Secondary|Number of Participants With Acute Rejection||12 months|ITT||participants|||Number
706156|NCT00105183|Secondary|Number of Participants With Death or Graft Loss Post-transplant||12 months|ITT population||participants|||Number
706157|NCT00105183|Primary|Number of Participants With the Event Death, Graft Loss, Acute Rejection and/or Loss to Follow-up (Whichever Occurred First)||12 months|ITT. During the interim analysis the 5 mg/kg arm was dropped and it was showed that the study was insufficiently powered so the main focus of study shifted to safety endpoints. Data is based on local lung biopsy readings for efficacy failure instead of central readings||participants|||Number
706158|NCT00105196|Other Pre-specified|MADRS Remission|Number of subjects in remission. Remission defined as as MADRS Total Score of <10 at 14 weeks, and a reduction of ≥50 percent from Week 8 (baseline) in MADRS, a 10-item, ordinal rating scale (0=no symptoms; 60=most severe symptoms).|Baseline (Week 8) and Week 14|||participants|||Number
706159|NCT00105196|Other Pre-specified|Clinical Global Impression (CGI)-Improvement Response|Number of subjects with response relative to Week 8 (baseline). Response defined as score of 1 (very much improved) or 2 (much improved) on a 7-point, ordinal scale (1=very much improved; 7=very much worse).|Baseline (Week 8) and Week 14|||Participants|||Number
706160|NCT00105196|Other Pre-specified|MADRS Response|Number of subjects with a ≥50 percent reduction from Week 8 (baseline) in MADRS Total Score, a 10-item, ordinal rating scale to assess the severity of depressive symptoms (0=no symptoms; 60=most severe symptoms).|Baseline (Week 8) and Week 14|||participants|||Number
706161|NCT00105196|Secondary|Mean Change in SDS Item Score (Work/School)|Mean change from Week 8 (baseline) to Week 14 in SDS Work/School Item Score, 1 item from a 3-item, ordinal scale (0=unimpaired; 10=highly impaired). Change from baseline=postbaseline score – baseline score. A negative change score indicates improvement.|Baseline (Week 8) and Week 14|||units on a scale||Standard Error|Mean
706162|NCT00105196|Secondary|Mean Change in SDS Item Score (Family Life)|Mean change from Week 8 (Baseline) to Week 14 in SDS Family Life Item Score, 1 item from a 3-item, ordinal scale (0=unimpaired; 10=highly impaired). Change from baseline=postbaseline score – baseline score. A negative change score indicates improvement.|Baseline (Week 8) and Week 14|||units on a scale||Standard Error|Mean
706163|NCT00105196|Secondary|Mean Change in SDS Item Score (Social Life)|Mean change from Week 8 (baseline) to Week 14 in SDS Social Life Item Score, 1 item from a 3-item, ordinal scale (0=unimpaired; 10=highly impaired). Change from baseline=postbaseline score – baseline score. A negative change score indicates improvement.|Baseline (Week 8) and Week 14|||units on a scale||Standard Error|Mean
706164|NCT00105196|Secondary|Mean Change in Sheehan Disability Scale (SDS) Mean Score|Mean change from Week 8 (baseline) to Week 14 in SDS Mean Score, a 3-item, ordinal scale (0=unimpaired; 30=highly impaired). Change from baseline=postbaseline score – baseline score. A negative change score indicates improvement.|Baseline (Week 8) and Week 14|||units on a scale||Standard Error|Mean
706165|NCT00105196|Primary|Mean Change in the Montgomery Åsberg Depression Rating Scale (MADRS)|Mean change from Week 8 (baseline) to Week 14 in MADRS total score, a 10-item, ordinal rating scale (0=no symptoms; 60=most severe symptoms). Change from baseline=postbaseline score – baseline score. A negative change score indicates improvement.|Baseline (Week 8) and Week 14|||units on a scale||Standard Error|Mean
706166|NCT00105235|Secondary|Proportion of Participants Successfully Withdrawn and Remain Off Immunosuppressants|This measure of tolerance induction includes the proportion of participants who qualify for immunosuppression withdrawal as determined by a review of individual clinical results by a protocol withdrawal committee, were successfully withdrawn from immunosuppressants, and remained off immunosuppressants at the time the trial ended. Successful withdrawal definition: participants who remain off immunosuppression for at least 8 weeks and do not restart immunosuppressant drugs after successful withdrawal.|From 1 year post- transplantation until study completion or participant termination (participants followed up to 48 months post-transplant)|Intent-to-treat||Proportion of Participants|||Number
706167|NCT00105235|Secondary|Proportion of Participants Successfully Withdrawn From Immunosuppressants|This measure of tolerance induction includes the proportion of participants who qualify for immunosuppression withdrawal as determined by a review of individual clinical results by a protocol withdrawal committee. Successful withdrawal definition: participants who remain off immunosuppression for at least 8 weeks.|From 1 year post- transplantation until study completion or participant termination (participants followed up to 48 months post-transplant)|Intent-to-treat||Proportion of Participants|||Number
706168|NCT00105235|Secondary|Number of Events: Immunosuppression-related Complications|Certain events are associated with immunosuppression. This measure looks at post-transplant infection, post-transplant malignancies, post-transplant diabetes, and post-transplant renal failure. Immunosuppression withdrawal is intended to reduce these type of events. However, reduction in immunosuppression can lead to complications in liver and renal function, as measured by acute rejection, chronic rejection, and post-transplant renal failure. Lower numbers for any of these events indicates greater success with transplantation and immunosuppression withdrawal (where applicable)|From transplantation until study completion or participant termination (participants followed up to 60 months)|Safety Sample||Events|||Number
706169|NCT00105235|Secondary|Proportion of Participants Who Had Graft Loss or Death|Proportion of participants who had liver graft loss or who died or terminated from the study within 2 years of initiating immunosuppression withdrawal|Within 2 years after initiation of immunosuppression withdrawal|Participants who initiated immunosuppression withdrawal||Proportion of Participants|||Number
706170|NCT00105235|Primary|Proportion of Participants Who Have Graft Loss or Death|Proportion of participants who had liver graft loss or who died within 1 year of undergoing transplantation. Note: Participants who discontinued treatment or terminated the study prior to 1 year post transplantation are considered treatment failures and are included in this measure.|Within 1 year of post-transplantation|Safety Sample||Proportion of Participants|||Number
706171|NCT00105443|Post-Hoc|Patients Reported Outcome (PRO) by Use of the FACT-Hep Questionnaire|PRO is a disease-specific measure, developed as symptom-focused approach in HCC and measured by the response rates for the PWB and FWB subscales of the 45-item Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire. The FACT-Hep response rate was based on the number of subjects who achieved the 8-point minimally important difference (MID) for this subscale. FACT-Hep total score ranges from 0 to 180, where the highest score represents a maximum achievable quality of life (QoL) value. At the cut-off date for this analysis, one more patient data has been gained.|from randomization to end of treatment up to the data cutoff date approximately 23 months after start of enrollment|In this study, the PRO was a tertiary efficacy variable assessed for the ITT population at Cycle 3 Day 1 or, for those discontinuing prior to that visit, at the end of study. It was summarized as number of patients with change from baseline <8 to ≥8 points for each treatment group up to the cutoff date of 09 Feb 2007.||Participants|||Number
706172|NCT00105443|Post-Hoc|Disease Control (DC)|The DC is defined as the number of subjects with a best response rating of CR, PR, or SD that is maintained at least 28 days from the first manifestation of that rating.|from randomization to end of treatment up to the data cutoff date approximately 23 months after start of enrollment|The disease control rate for the ITT population was determined by independent radiological review and also by investigator assessment (both by using response evaluation criteria in solid tumors (RECIST) up to the cutoff date of 09 Feb 2007||Participants|||Number
706173|NCT00105443|Post-Hoc|Time to Progression (TTP)|TTP was defined as the time from randomization to disease progression (radiological only). Subjects without tumor progression at the time of analysis were censored at their last date of tumor evaluation.|from randomization to disease progression based on radiological assessment until an average 2.8 months later up to the data cut-off date approximately 23 months after start of enrollment|The independent radiological review as initially scheduled for the interim analysis did not continue after 12 May 2006. The primary analysis of TTP for the ITT population after 12 May 2006 up to the cutoff date of 09 Feb 2007 was based on the Investigator radiological assessments||Days||95% Confidence Interval|Median
706174|NCT00105443|Post-Hoc|Time to Symptomatic Progression (TTSP)|TTSP was defined as the time from randomization to the first documented symptomatic progression|from randomization to the first documented symptomatic progression until an average 5.7 months later up to the data cut-off date approximately 23 months after start of enrollment|For subjects (in the ITT population) who had not progressed symptomatically at the time of interim analysis, TTSP was censored at the date of last FACT FHSI-8 questionnaire assessment (upon an interim review by the Data Monitoring Committee on 09 Feb 2007), when the study was considered positive for its primary endpoint, OS, and was stopped early.||Days||95% Confidence Interval|Median
706175|NCT00105443|Post-Hoc|Overall Survival|Overall Survival was defined as the time from date of starting treatment to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.|from randomization to death due to any cause until an average 8.5 months later up to the data cut-off date approximately 23 months after start of enrollment|The OS data (ITT population) are descriptive only (no p-values) from the date of randomization to the date of death due to any cause. For patients alive at the time of analysis, time to death was censored at the date of last follow-up or at the data cutoff date of 09 Feb 2007 when subjects were given the option to crossover to sorafenib treatment||Days||95% Confidence Interval|Median
706176|NCT00105443|Secondary|Patients Reported Outcome (PRO) by Use of the FACT-Hep Questionnaire|PRO is a disease-specific measure, developed as symptom-focused approach in HCC and measured by the response rates for the PWB and FWB subscales of the 45-item Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire. The FACT-Hep response rate was based on the number of subjects who achieved the 8-point minimally important difference (MID) for this subscale. FACT-Hep total score ranges from 0 to 180, where the highest score represents a maximum achievable quality of life (QoL) value.|from randomization to end of treatment up to the data cutoff date approximately 19 months after start of enrollment|In this study, the PRO was a tertiary efficacy variable assessed for the ITT population at Cycle 3 day 1 or, for those discontinuing prior to that visit, at end of study. It was summarized as number of patients with change from baseline <8 or ≥8 points for each treatment group up to the cutoff date of 17 Oct 2006||Participants|||Number
706177|NCT00105443|Secondary|Disease Control (DC)|The DC is defined as the number of subjects with a best response rating of complete response (CR), partial response (PR), or stable disease (SD) that is maintained at least 28 days from the first manifestation of that rating. Definitions: CR = disappearance of all clinical and radiological tumor lesions; PR = at least 30% decrease in sum of the longest diameters of tumor lesions; SD = neither sufficient shrinkage to qualify for PR nor sufficient increase for progressive disease.|time from randomization to end of treatment up to the data cutoff date approximately 19 months after start of enrollment|In this study, the DC for the ITT population was determined by independent radiological review and also by investigator assessment (both by using response evaluation criteria in solid tumors [RECIST])||Participants|||Number
706178|NCT00105443|Secondary|Time to Progression (TTP)|TTP was defined as the time from randomization to disease progression (radiological only). Subjects without tumor progression at the time of analysis were censored at their last date of tumor evaluation.|from randomization to disease progression based on radiological assessment until an average 2.8 months later up to the data cut-off date approximately 19 months after start of enrollment|The primary analysis of TTP for the ITT population was based on the independent radiological review for the interim analysis. The cut-off date chosen for the analysis of radiological progression events was 12 May 2006||days||95% Confidence Interval|Median
706179|NCT00105443|Primary|Time to Symptomatic Progression (TTSP)|TTSP was defined as the time from randomization to the first documented symptomatic progression.|from randomization to the first documented symptomatic progression until an average 4.8 months later up to the data cut-off date approximately 19 months after start of enrollment|This analysis was for the ITT population. For subjects who had not progressed symptomatically at the time of interim analysis, TTSP was censored at the date of their last Functional Assessment of Cancer Therapy (FACT) Hepatobiliary Symptom Index (FHSI-8) questionnaire assessment.||days||95% Confidence Interval|Median
706180|NCT00105443|Primary|Overall Survival (OS)|Overall Survival was defined as the time from date of starting treatment to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.|from randomization to death due to any cause until an average 7.2 months later up to the data cut-off date approximately 19 months after start of enrollment|In this study the overall survival was measured for the ITT population from the date of randomization until the date of death due to any cause. For patients alive or lost to follow-up at the time of analysis, time to death was to be censored at their last date of follow-up, or at the data cut-off of 17 Oct 2006.||days||95% Confidence Interval|Median
706181|NCT00105469|Secondary|Number of Participants Who Achieved Bacterial Eradication at Visit 3|Bacterial eradication is defined as eradication of the causative pathogens as indicated by the absence of growth (0 colony forming units/mL) of the original infecting organism(s).|Visit 3 (Day 6)|"Per protocol population (defined as all randomized
subjects who had administered at least one drop of the appropriate study drug, demonstrated evidence of
pathogenic bacteria levels, presented clinical signs of conjunctivitis at Visit 1, and returned for at least one post-first dose clinical assessment) with last observation carried forward."||Participants|||Number
706182|NCT00105469|Primary|Number of Participants Who Achieved Clinical Resolution at Visit 3|Clinical resolution is defined as absence of all three clinical signs (ocular discharge, bulbar conjunctival injection, and palpebral conjunctival injection).|Visit 3 (Day 6)|"Per protocol population (defined as all randomized
subjects who had administered at least one drop of the appropriate study drug, demonstrated evidence of
pathogenic bacteria levels, presented clinical signs of conjunctivitis at Visit 1, and returned for at least one post-first dose clinical assessment) with last observation carried forward."||Participants|||Number
706188|NCT00113425|Secondary|Change From Baseline in Acne Severity at Week 16|The Leeds scale is a 12-point ordinal photonumeric global acne severity scale where a rating of 1 denotes the mildest acne and a rating of 12 represents the most severe.|Baseline and Week 16|||units on a scale||95% Confidence Interval|Mean
706189|NCT00113425|Secondary|Change From Baseline in Erythematous Macules at Week 16||Baseline and Week 16|||erythematous macules||95% Confidence Interval|Mean
706190|NCT00113425|Secondary|Change From Baseline in Open Comedones at Week 16||Baseline and Week 16|||open comedones||95% Confidence Interval|Mean
706191|NCT00113425|Secondary|Change From Baseline in Closed Comedones at Week 16||Baseline and Week 16|||closed comedones||95% Confidence Interval|Mean
706192|NCT00113425|Secondary|Change From Baseline in Cysts at Week 16||Baseline and Week 16|||cysts||95% Confidence Interval|Mean
706193|NCT00113425|Secondary|Change From Baseline in Pustule Acne Lesions at Week 16||Baseline and Week 16|||pustule acne lesions||95% Confidence Interval|Mean
706194|NCT00113425|Secondary|Change From Baseline in Papule Acne Lesions at Week 16||Baseline and Week 16|||papule acne lesions||95% Confidence Interval|Mean
706195|NCT00113425|Primary|Change From Baseline in Acne Severity at Week 10|The Leeds scale is a 12-point ordinal photonumeric global acne severity scale where a rating of 1 denotes the mildest acne and a rating of 12 represents the most severe.|Baseline and Week 10|||units on a scale||95% Confidence Interval|Mean
706196|NCT00113425|Primary|Change From Baseline in Erythematous Macules at Week 10||Baseline and Week 10|||erythematous macules||95% Confidence Interval|Mean
706197|NCT00113425|Primary|Change From Baseline in Open Comedones at Week 10||Baseline and Week 10|||open comedones||95% Confidence Interval|Mean
706198|NCT00113425|Primary|Change From Baseline in Closed Comedones at Week 10||Baseline and Week 10|||closed comedones||95% Confidence Interval|Mean
706199|NCT00113425|Primary|Change From Baseline in Cysts at Week 10||Baseline and Week 10|||cysts||95% Confidence Interval|Mean
706200|NCT00113425|Primary|Change From Baseline in Pustule Acne Lesions at Week 10||Baseline and Week 10|||pustule acne lesions||95% Confidence Interval|Mean
706201|NCT00113425|Primary|Change From Baseline in Papule Acne Lesions at Week 10||Baseline and Week 10|||papule acne lesions||95% Confidence Interval|Mean
706202|NCT00113490|Secondary|Motavizumab Serum Concentrations at Each Data Collection Visit|Mean serum concentration.|Prior to dosing on Day 0, Day 30, Day 120, and at 30 and 90-120 days post final dose|All subjects who received any study drug were included in all summaries. Day 0 n= 66; Day 25-30 n=65; Day 120 n=63; 30 days post final dose n=63; 90-120 days post final dose n=62||ug/mL||Standard Deviation|Mean
706203|NCT00113490|Secondary|Number of Subjects With Increased Toxicity Grade From Baseline as Determined by Laboratory Evaluations|Serum chemistry and hematology parameters were measured at baseline, on Days 25-30 and 120, 30 days post the final dose, and at premature discontinuation.|Day 0 through 30 days post final dose|All subjects who received any study drug were included in all summaries of safety.||participants|||Number
706204|NCT00113490|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|Assessments of SAEs were made by clinical investigators according to the protocol.|Day 0 through 30 days post final dose|All subjects who received any study drug were included in all summaries of safety.||participants|||Number
706205|NCT00113490|Secondary|Number of Subjects Reporting Adverse Events (AEs)|Assessments of adverse events (including SAEs) were made by clinical investigators according to the protocol.|Day 0 through 30 days post final dose|All subjects who received any study drug were included in all summaries of safety.||participants|||Number
706206|NCT00113490|Primary|Number of Subjects Exhibiting Anti-motavizumab Antibodies|Serum for measurement of anti-motavizumab antibodies was collected prior to the first, second and, if applicable, fifth doses of study drug, and at the 2 follow-up visits 30 and 90-120 days post final dose.|Day 0 through 120 days post final dose|All subjects who received any study drug were included in all summaries of immunogenicity. Day 0 n=66 mota, n=70 pali; Day 25-30 n=65 mota, n=69 pali; Day 120 n=64 mota, n=67 pali; 30 days post final dose n=65 mota, n=67 pali; 90-120 days post final dose n=64 mota, n=67 pali; at any time n=66 mota, n=70 pali.||participants|||Number
706207|NCT00113516|Secondary|Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13)|QLQ-LC13 assessed lung cancer symptoms (dyspnea, coughing, dysphasia, hemoptysis, sore mouth, peripheral neuropathy, alopecia, chest pain, arm pain, shoulder pain, and pain in other parts). Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms. Change: score at each visit in Part 2 minus baseline score in Part 1.|Baseline (Part 1) to Cycle1 (Days 1 [baseline], 28), Cycles 2 and 3 (Days 1, 28), and Cycle 4 (Day 1) in Part 2|ITT. Number of participants analyzed = number of subjects with EORTC response (defined as having at least 1 item response on the EORTC). n=number of subjects with EORTC scale score at baseline and each specified time point. Data in cycles with less than 9 subjects are not reported due to lack of statistical reliability.||scores on a scale||Standard Error|Mean
706208|NCT00113516|Secondary|Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30)|EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms. Change: score at each visit in Part 2 minus baseline score in Part 1.|Baseline (Part 1) to Cycle1 (Days 1 [baseline], 28), Cycles 2 and 3 (Days 1, 28), and Cycle 4 (Day 1) in Part 2|ITT. Number of participants analyzed = number of subjects with EORTC response (defined as having at least 1 item response on the EORTC). n=number of subjects with EORTC scale score at baseline and each specified time point. Data in cycles with less than 9 subjects are not reported due to lack of statistical reliability.||scores on a scale||Standard Error|Mean
706209|NCT00113516|Secondary|Correlation of Polymorphisms in c-Kit, Flt-3 and c-Fms to Safety of Sunitinib|A blood sample (6 mL) was collected and used to isolate DNA. These samples were not anonymized.|Within 7 days of Day 1|c-Kit, Flt-3 and c-Fms to safety of Sunitinib samples were collected and analyzed. However, there was no statistics performed since power was insufficient.||pg/mL|||Number
706210|NCT00113516|Secondary|Immunohistochemical Staining of Paraffin Embedded Tumor Tissue|Previously collected tumor paraffin block (or 12-20 10-micron slides prepared for the paraffin block) for correlative laboratory analysis.|Screening|Samples were collected and stained from a subset of subjects. Due to the small sample size, no correlative analyses with clinical outcome were conducted.||samples|||Number
706211|NCT00113516|Secondary|Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline and Changes From Baseline|OS=time from start of study treatment to death due to any cause. OS (in months) calculated as (date of death minus date of sunitinib first dose +1) divided by 30.4. For subjects not expiring their survival times were censored at last date of known contact they were known to be alive. Subjects lacking data beyond day of first dose of sunitinib had their survival time censored at Day 1 of sunitinib treatment. Groups are defined by < or > = median levels of soluble E-selectin at Baseline and after stratification by < or > = median changes from Baseline in soluble E-selectin at each time point.|Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 4 (Day 28), Cycle 5 (Day 28) of Part 2|MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. At Cycle 3, Day 1 (< median cutpoint), Cycle 4, Day 28 (< median cutpoint, > = median cutpoint)and Cycle 5, Day 28 (< median cutpoint), median and/or CI were not able to be estimated.||months||95% Confidence Interval|Median
706212|NCT00113516|Secondary|Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline|OS = time from start of study treatment to death due to any cause. OS (in months) was calculated as (date of death minus date of sunitinib first dose +1) divided by 30.4. For subjects not expiring, their survival times were censored at the last date of known contact they were known to be alive. Subjects lacking data beyond the day of first dose of sunitinib had their survival time censored at Day 1 of sunitinib treatment. Groups are defined by < or > = median levels of VEGF-C at Baseline and after stratification by < or > = median changes from Baseline in VEGF-C at each time point.|Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2|MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. At Cycle 3, Day 28 (> = median cutpoint), median and/or CI were not able to be estimated.||months||95% Confidence Interval|Median
706213|NCT00113516|Secondary|Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline Changes From Baseline|OS = time from start of study treatment to death due to any cause. OS (in months) was calculated as (date of death minus date of sunitinib first dose +1)divided by 30.4. For subjects not expiring, their survival times were censored at the last date of known contact they were known to be alive. Subjects lacking data beyond the day of first dose of sunitinib had their survival time censored at Day 1 of sunitinib treatment. Groups are defined by < or > = median levels of VEGFR3 at Baseline and after stratification by < or > = median changes from Baseline in VEGFR3 at each time point.|Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2|MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. At Cycle 3, Day 1 (< median cutpoint), median and/or CI were not able to be estimated.||months||95% Confidence Interval|Median
706214|NCT00113516|Secondary|Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline Changes From Baseline|TTP = time from start of study treatment to first documentation of objective disease progression. If tumor progression data included more than 1 date, the first date was used. TTP (in weeks) was calculated as (first event date minus first sunitinib dose date +1) divided by 7.02. Groups are defined by < or > = median levels of soluble E-selectin at Baseline and after stratification by < or > = median changes from Baseline in soluble E-selectin at each time point.|Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 4 (Day 28), Cycle 5 (Day 28) of Part 2|MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. At Cycle 2, Day 28 (> = median cutpoint), Cycle 3, Day 28 (< median cutpoint), and Cycles 4 and 5, Day 28 (< median cutpoint, > = median cutpoint), median and/or CI were not able to be estimated.||weeks||95% Confidence Interval|Median
706215|NCT00113516|Secondary|Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline|TTP = time from start of study treatment to first documentation of objective disease progression. If tumor progression data included more than 1 date, the first date was used. TTP (in weeks) was calculated as (first event date minus first sunitinib dose date +1) divided by 7.02. Groups are defined by < or > = median levels of VEGF-C at Baseline and after stratification by < or > = median changes from Baseline in VEGF-C at each time point.|Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2|MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. At Cycle 3, Day 28 (< median cutpoint), and Cycle 5, Day 28 (< median cutpoint, > = median cutpoint), median and/or CI were not able to be estimated.||weeks||95% Confidence Interval|Median
706216|NCT00113516|Secondary|Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline|TTP = time from start of study treatment to first documentation of objective disease progression. If tumor progression data included more than 1 date, the first date was used. TTP (in weeks) was calculated as (first event date minus first sunitinib dose date +1) divided by 7.02. Groups are defined by < or > = median levels of VEGFR3 at Baseline and after stratification by < or > = median changes from baseline in VEGFR3 at each time point.|Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2|MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. At Cycle 3, Day 28 (< median cutpoint) and Cycle 5, Day 28 (> = median cutpoint), median and/or CI were not able to be estimated.||weeks||95% Confidence Interval|Median
706226|NCT00113516|Secondary|Soluble E-Selectin Ratio to Baseline at Each Time Point|Soluble E-Selectin concentration at each time point divided by soluble E-Selectin concentration at baseline (ratio to baseline).|Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 4 (Day 28), Cycle 5 (Day 28) of Part 2|MITT. n=number of subjects with levels of soluble protein biomarkers at baseline and at the specified time point. At Cycle 4, Day 28, median and/or standard deviation were not able to be estimated.||ratio||Standard Deviation|Mean
706227|NCT00113516|Secondary|Soluble E-Selectin at Baseline|Concentration of soluble E-Selectin at baseline.|Baseline (Cycle 1, Day 1) of Part 2|MITT. Number of participants analyzed = number of subjects with soluble E-Selectin data at Baseline.||nanograms (ng)/mL||Standard Deviation|Mean
706217|NCT00113516|Secondary|Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline and Changes From Baseline|PFS = time from start of study treatment to first documentation of objective disease progression or to death on study due to any cause, whichever was first. If tumor progression data included more than 1 date, the first date was used. PFS (in weeks) was calculated as (first event date minus first sunitinib dose date +1) divided by 7.02. Groups are defined by < or > = median levels of soluble E-selectin at Baseline and after stratification by < or > = median changes from Baseline in soluble E-selectin at each time point.|[Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 4 (Day 28), Cycle 5 (Day 28) of Part 2|MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. At Cycle 2, Day 28 (> = median cutpoint), Cycle 3, Day 28 (< median cutpoint), and Cycles 4 and 5, Day 28 (< median cutpoint, > = median cutpoint), median and/or CI were not able to be estimated.||weeks||95% Confidence Interval|Median
706218|NCT00113516|Secondary|Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline|PFS = time from start of study treatment to first documentation of objective disease progression or to death on study due to any cause, whichever was first. If tumor progression data included more than 1 date, the first date was used. PFS (in weeks) was calculated as (first event date minus first sunitinib dose date +1) divided by 7.02. Groups are defined by < or > = median levels of VEGF-C at Baseline and after stratification by < or > = median changes from Baseline in VEGF-C at each time point.|Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2|MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. At Cycle 3, Day 28 (< median cutpoint) and Cycle 5, Day 28 (< median cutpoint), median and/or CI were not able to be estimated.||weeks||95% Confidence Interval|Median
706219|NCT00113516|Secondary|Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline|PFS = time from start of study treatment to first documentation of objective disease progression or to death on study due to any cause, whichever was first. If tumor progression data included more than 1 date, the first date was used. PFS (in weeks) was calculated as (first event date minus first sunitinib dose date +1)divided by 7.02. Groups are defined by < or > = median levels of VEGFR3 at Baseline and after Stratification by < or > = median changes from Baseline in VEGFR3 at each time point.|Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2|MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. At Cycle 3, Day 28 (< median cutpoint) and Cycle 5, Day 28 (> = median cutpoint), median and/or CI were not able to be estimated.||weeks||95% Confidence Interval|Median
706220|NCT00113516|Secondary|Soluble E-Selectin Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD)|Median soluble E-selectin concentration at each time point divided by median soluble E-selectin concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR or [SD > = 6 weeks] or PD). A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 4 (Day 28), Cycle 5 (Day 28) of Part 2|MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. No subjects had PD at Cycle 4, Day 28 and Cycle 5, Day 28.||ratio|||Number
706221|NCT00113516|Secondary|Soluble E-Selectin at Baseline Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD)|Median concentration of soluble E-selectin at baseline stratified by tumor response (CR or PR or [SD > = 6 Weeks] or PD). A measure of dispersion is not included because the Wilcoxon rank sum test is a nonparametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline (Cycle 1, Day 1) of Part 2|MITT. n=number of subjects with levels of soluble protein biomarkers and tumor response at baseline.||pg/mL|||Number
706222|NCT00113516|Secondary|VEGF-C Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD)|Median VEGF-C concentration at each time point divided by median VEGF-C concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR or [SD > = 6 weeks] or PD). A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2|MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. No subjects had PD at Cycle 5, Day 28.||ratio|||Number
706223|NCT00113516|Secondary|VEGF-C at Baseline Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD)|Median concentration of VEGF-C at baseline stratified by tumor response (CR or PR or [SD > = 6 Weeks] or PD). A measure of dispersion is not included because the Wilcoxon rank sum test is a nonparametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline (Cycle 1, Day 1) of Part 2|MITT. n=number of subjects with levels of soluble protein biomarkers and tumor response at baseline.||pg/mL|||Number
706224|NCT00113516|Secondary|VEGFR3 Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD)|Median VEGFR3 concentration at each time point divided by median VEGFR3 concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR or [SD > = 6 weeks] or PD). A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2|MITT. n=number of subjects with levels of soluble protein biomarkers at baseline and at the specified time point. No subjects had PD at Cycle 5, Day 28.||ratio|||Number
706225|NCT00113516|Secondary|VEGFR3 at Baseline Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD)|Median concentration of VEGFR3 at baseline stratified by tumor response (CR or PR or [SD > = 6 Weeks] or PD). A measure of dispersion is not included because the Wilcoxon rank sum test is a nonparametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline (Cycle 1, Day 1) of Part 2|MITT. n=number of subjects with levels of soluble protein biomarkers and tumor response at baseline.||pg/mL|||Number
706228|NCT00113516|Secondary|VEGF-C Ratio to Baseline at Each Time Point|VEGF-C concentration at each time point divided by VEGF-C concentration at baseline (ratio to baseline).|Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2|MITT. n=number of subjects with levels of soluble protein biomarkers at baseline and at the specified time point.||ratio||Standard Deviation|Mean
706230|NCT00113516|Secondary|VEGFR3 Ratio to Baseline at Each Time Point|VEGFR3 concentration at each time point divided by VEGFR3 concentration at baseline (ratio to baseline).|Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2|MITT. n=number of subjects with levels of soluble protein biomarkers at baseline and at the specified time point.||ratio||Standard Deviation|Mean
706231|NCT00113516|Secondary|Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) Concentration at Baseline|Concentration of VEGFR3 at baseline.|Baseline (Cycle 1, Day 1) of Part 2|Modified ITT population (MITT) = all subjects enrolled in the study who received at least 1 dose of paclitaxel/carboplatin and at least 1 dose of Sunitinib.||picograms (pg)/milliliter (mL)||Standard Deviation|Mean
706232|NCT00113516|Secondary|Dose-Corrected Ctrough of Total Drug (Sunitinib + SU-012662)|Ctrough = the plasma concentration prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. This was determined due to potential dose changes throughout the study in different subjects. It was calculated as the observed values multiplied by the reference dose (50 mg) divided by the actual dose. For dose-corrected trough concentration, only trough concentration values from subjects who received sunitinib during at least the last 10 consecutive days of dosing at the same dose level were included.|predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2|PK. Subjects with plasma values below limit of quantification were excluded.||ng/mL||Standard Deviation|Mean
706233|NCT00113516|Secondary|Dose-Corrected Ctrough of SU-012662 (Sunitinib's Metabolite)|Ctrough = the plasma concentration prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. This was determined due to potential dose changes throughout the study in different subjects. It was calculated as the observed values multiplied by the reference dose (50 mg) divided by the actual dose. For dose-corrected trough concentration, only trough concentration values from subjects who received sunitinib during at least the last 10 consecutive days of dosing at the same dose level were included.|predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2|PK. Subjects with plasma values below limit of quantification were excluded.||ng/mL||Standard Deviation|Mean
706234|NCT00113516|Secondary|Dose-Corrected Ctrough of Sunitinib|Ctrough = the plasma concentration prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. This was determined due to potential dose changes throughout the study in different subjects. It was calculated as the observed values multiplied by the reference dose (50 mg) divided by the actual dose. For dose-corrected trough concentration, only trough concentration values from subjects who received sunitinib during at least the last 10 consecutive days of dosing at the same dose level were included.|predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2|PK. Subjects with plasma values below limit of quantification were excluded.||ng/mL||Standard Deviation|Mean
706235|NCT00113516|Secondary|Ctrough of Total Drug (Sunitinib + SU-012662)|Ctrough = the plasma concentration prior to study drug administration. On Day 28, this parameter provided and idea of the concentration at steady state since no big fluctuation was expected in a 24 hour interval.|predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2|PK. Subjects with plasma values below limit of quantification were excluded.||ng/mL||Standard Deviation|Mean
706236|NCT00113516|Secondary|Ctrough of SU-012662 (Sunitinib's Metabolite)|Ctrough = the plasma concentration prior to study drug administration. On Day 28, this parameter provided and idea of the concentration at steady state since no big fluctuation was expected in a 24 hour interval.|predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2|PK. Subjects with plasma values below limit of quantification were excluded.||ng/mL||Standard Deviation|Mean
706237|NCT00113516|Secondary|Trough Plasma Concentration (Ctrough) of Sunitinib|Ctrough = the plasma concentration prior to study drug administration. On Day 28, this parameter provided and idea of the concentration at steady state since no big fluctuation was expected in a 24 hour interval.|predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2|Pharmacokinetic (PK) = all subjects enrolled in the study who received at least 1 dose of carboplatin/paclitaxel or sunitinib. Subjects with plasma values below limit of quantification were excluded.||nanograms (ng)/milliliter (mL)||Standard Deviation|Mean
706238|NCT00113516|Secondary|Overall Survival (OS)|OS was defined as the time from start of study treatment to death due to any cause. OS (in months) was calculated as (date of death − date of paclitaxel/carboplatin first dose +1)/30.4. For subjects not expiring, their survival times were censored at the last date of known contact they were known to be alive. Subjects lacking data beyond the day of first dose of paclitaxel/carboplatin had their survival time censored at Day 1 of paclitaxel/carboplatin treatment.|From start of study treatment until death|ITT||months||95% Confidence Interval|Median
706239|NCT00113516|Secondary|Number of Subjects With Overall Confirmed Objective Disease Response|Objective disease response = subjects with confirmed CR or PR according to the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.0). A CR was defined as the disappearance of all target lesions. A PR was defined as a ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|From start of treatment until Day 21 of Cycles 2 and 4 (Carboplatin plus Paclitaxel), Day 28 of Cycles 1, 2, 3, 4, and even cycles thereafter (Sunitinib)|ITT||participants|||Number
706240|NCT00113516|Secondary|Duration of Response (DR)|DR=time from the first documentation of objective tumor response (complete response [CR] or partial response [PR]) that was subsequently confirmed to first documentation of objective disease progression or death due to any cause, whichever was first. CR=disappearance of all target lesions. PR=a > = 30% decrease in sum of longest dimensions of target lesions taking as a reference baseline sum longest dimensions. If tumor progression data included more than 1 date, first date was used. DR (in weeks) was calculated as (the end date for DR – first CR or PR that was subsequently confirmed +1)/7.02.|From start of treatment until Day 21 of Cycles 2 and 4 (Carboplatin plus Paclitaxel), Day 28 of Cycles 1, 2, 3, 4, and even cycles thereafter (Sunitinib) or death|ITT. DR was calculated for the subgroup of subjects with objective response. 23 subjects reported CR or PR response and were analyzed for DR.||weeks||95% Confidence Interval|Median
706241|NCT00113516|Secondary|Time to Tumor Progression (TTP)|TTP was defined as the time from start of study treatment to first documentation of objective disease progression. If tumor progression data included more than 1 date, the first date was used. TTP (in weeks) was calculated as (first event date – first paclitaxel/carboplatin dose date +1)/7.02.|From start of treatment until Day 21 of Cycles 2 and 4 (Carboplatin plus Paclitaxel), Day 28 of Cycles 1, 2, 3, 4, and even cycles thereafter (Sunitinib)|ITT||weeks||95% Confidence Interval|Median
710935|NCT00168844|Secondary|Change From Baseline in Monocytes|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||percentage of white blood cell count||Standard Deviation|Mean
706242|NCT00113516|Secondary|Progression-free Survival (PFS)|PFS was defined as the time from start of study treatment to first documentation of objective disease progression or to death on study due to any cause, whichever was first. If tumor progression data included more than 1 date, the first date was used. PFS (in weeks) was calculated as (first event date - first paclitaxel/carboplatin dose date +1)/7.02.|From start of treatment until Day 21 of Cycles 2 and 4 (Carboplatin plus Paclitaxel), Day 28 of Cycles 1, 2, 3, 4, and even cycles thereafter (Sunitinib) or death|ITT||weeks||95% Confidence Interval|Median
706243|NCT00113516|Primary|Proportion of Subjects Surviving at One Year|Proportion of those surviving at the end of one year from the first dose of study treatment. In the absence of confirmation of death, survival time was censored at the last date the subject was known to be alive. Patients lacking data beyond the day of first dose had their survival time censored at Day 1 of treatment.|From start of treatment until 1 year or death|Intent-to-treat (ITT) population = all subjects enrolled in the study who received at least 1 dose of paclitaxel/carboplatin.||proportion|||Number
706244|NCT00113529|Secondary|Ctrough of Gefitinib||prior to dosing on Cycle 1 (Days 1, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28)|PK = the ITT population of subjects who had completed PK blood sampling for at least one day. n=number of subjects with trough plasma concentrations at the specified time point.||ng/mL||Standard Deviation|Mean
706245|NCT00113529|Secondary|Ctrough of SU-012662 (Sunitinib's Metabolite)||prior to dosing on Cycle 1 (Days 1, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28)|PK = the ITT population of subjects who had completed PK blood sampling for at least one day. n=number of subjects with trough plasma concentrations at the specified time point.||ng/mL||Standard Deviation|Mean
706246|NCT00113529|Secondary|Trough Plasma Concentrations (Ctrough) of Sunitinib||prior to dosing on Cycle 1 (Days 1, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28)|Pharmacokinetic (PK) = the ITT population of subjects who had completed PK blood sampling for at least one day. n=number of subjects with trough plasma concentrations at the specified time point.||ng/mL||Standard Deviation|Mean
706247|NCT00113529|Secondary|Change From Baseline in VEGFR3 by Time Point Stratified by TTP >= Median and TTP < Median|Change = median VEGFR3 level at each specified time point for subjects with tumor response TTP >= Median and TTP < Median minus median VEGFR3 level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive|ITT. Number of participants analyzed = number of subjects evaluable for TTP (ie, those who died or had tumor progression) with baseline biomarker values. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point.||pg/mL|||Number
706248|NCT00113529|Secondary|Change From Baseline in VEGFR2 by Time Point Stratified by TTP >= Median and TTP < Median|Change = median VEGFR2 level at each specified time point for subjects with tumor response TTP >= Median and TTP < Median minus median VEGFR2 level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive|ITT. Number of participants analyzed = number of subjects evaluable for TTP (ie, those who died or had tumor progression) with baseline biomarker values. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point.||pg/mL|||Number
706249|NCT00113529|Secondary|Change From Baseline in VEGFC by Time Point Stratified by TTP >= Median and TTP < Median|Change = median VEGFC level at each specified time point for subjects with tumor response TTP >= Median and TTP < Median minus median VEGFC level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive|ITT. Number of participants analyzed = number of subjects evaluable for TTP (ie, those who died or had tumor progression) with baseline biomarker values. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point.||pg/mL|||Number
706250|NCT00113529|Secondary|Change From Baseline in VEGF by Time Point Stratified by TTP >= Median and TTP < Median|Change = median VEGF level at each specified time point for subjects with tumor response TTP >= Median and TTP < Median minus median VEGF level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive|ITT. Number of participants analyzed = number of subjects evaluable for TTP (ie, those who died or had tumor progression) with baseline biomarker values. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point.||pg/mL|||Number
706251|NCT00113529|Secondary|Change From Baseline in VEGFR3 by Time Point Stratified by PFS >= Median and PFS < Median|Change = median VEGFR3 level at each specified time point for subjects with tumor response PFS >= Median or PFS < Median minus median VEGFR3 level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive|ITT. Number of participants analyzed = number of subjects evaluable for PFS (ie, those who died or had tumor progression) with baseline biomarker values. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point.||pg/mL|||Number
706252|NCT00113529|Secondary|Change From Baseline in VEGFR2 by Time Point Stratified by PFS >= Median and PFS < Median|Change = median VEGFR2 level at each specified time point for subjects with tumor response PFS >= Median or PFS < Median minus median VEGFR2 level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive|ITT. Number of participants analyzed = number of subjects evaluable for PFS (ie, those who died or had tumor progression) with baseline biomarker values. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point.||pg/mL|||Number
706267|NCT00113529|Secondary|Probability of Survival at One Year|Survival rate was defined as the percentage of subjects alive at 1 year after the date of first administration of study medication. Survival rate was estimated using the Kaplan-Meier method.|From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter up until 1 year|ITT||probability|||Number
706806|NCT00116831|Secondary|Change From Baseline to Month 18 in Total Cholesterol/HDL-c Ratio|From repeated measures analysis model: Change = baseline + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.|Baseline to Month 18|ITT Population without LOCF||ratio||Standard Error|Mean
706253|NCT00113529|Secondary|Change From Baseline in VEGFC by Time Point Stratified by PFS >= Median and PFS < Median|Change = median VEGFC level at each specified time point for subjects with tumor response PFS >= Median or PFS < Median minus median VEGFC level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive|ITT. Number of participants analyzed = number of subjects evaluable for PFS (ie, those who died or had tumor progression) with baseline biomarker values. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point.||pg/mL|||Number
706254|NCT00113529|Secondary|Change From Baseline in VEGF by Time Point Stratified by PFS >= Median and PFS < Median|Change = median VEGF level at each specified time point for subjects with tumor response PFS >= Median or PFS < Median minus median VEGF level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive|ITT. Number of participants analyzed = number of subjects evaluable for PFS (ie, those who died or had tumor progression) with baseline biomarker values. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point.||pg/mL|||Number
706255|NCT00113529|Secondary|Change From Baseline in VEGFR3 by Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] Versus PD)|Change = median VEGFR3 level at each specified time point for subjects with tumor response (CR or PR or [SD > = 6 weeks] versus PD) minus median VEGFR3 level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive|ITT. Number of participants analyzed = number of subjects with soluble protein biomarkers at baseline. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point.||pg/mL|||Number
706256|NCT00113529|Secondary|Change From Baseline in VEGFR2 by Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] Versus PD)|Change = median VEGFR2 level at each specified time point for subjects with tumor response (CR or PR or [SD > = 6 weeks] versus PD) minus median VEGFR2 level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive|ITT. Number of participants analyzed = number of subjects with soluble protein biomarkers at baseline. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point.||pg/mL|||Number
706257|NCT00113529|Secondary|Change From Baseline in VEGFC by Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] Versus PD)|Change = median VEGFC level at each specified time point for subjects with tumor response (CR or PR or [SD > = 6 weeks] versus PD) minus median VEGFC level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive|ITT. Number of participants analyzed = number of subjects with soluble protein biomarkers at baseline. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point.||pg/mL|||Number
706258|NCT00113529|Secondary|Change From Baseline in VEGF by Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] Versus PD)|Change = median VEGF level at each specified time point for subjects with tumor response (CR or PR or [SD > = 6 weeks] versus PD) minus median VEGF level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive|ITT. Number of participants analyzed = number of subjects with soluble protein biomarkers at baseline. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point.||pg/mL|||Number
706259|NCT00113529|Secondary|sVEGFR3 Ratio to Baseline at Each Time Point|sVEGFR3 concentration at each time point divided by sVEGFR3 concentration at baseline (ratio to baseline).|Baseline to Cycle 3, Day 28 inclusive|ITT. Number of participants analyzed = number of subjects with soluble protein biomarkers at baseline. n=number of subjects with levels of soluble protein biomarkers at baseline and at the specified time point.||ratio||Standard Deviation|Mean
706260|NCT00113529|Secondary|Soluble VEGF Receptor 3 (sVEGFR3) Concentration at Baseline|Concentration of sVEGFR3 at baseline.|Baseline (Cycle 1, Day 1)|ITT. Number of participants analyzed = number of subjects with soluble protein biomarkers at baseline.||pg/mL||Standard Deviation|Mean
706261|NCT00113529|Secondary|sVEGFR2 Ratio to Baseline at Each Time Point|sVEGFR2 concentration at each time point divided by sVEGFR2 concentration at baseline (ratio to baseline).|Baseline to Cycle 3, Day 28 inclusive|ITT. Number of participants analyzed = number of subjects with soluble protein biomarkers at baseline. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point.||ratio||Standard Deviation|Mean
706262|NCT00113529|Secondary|Soluble VEGF Receptor 2 (sVEGFR2) Concentration at Baseline|Concentration of sVEGFR2 at baseline.|Baseline (Cycle 1, Day 1)|ITT. Number of participants analyzed = number of subjects with soluble protein biomarkers at baseline.||pg/mL||Standard Deviation|Mean
706263|NCT00113529|Secondary|VEGF-C Ratio to Baseline at Each Time Point|VEGF-C concentration at each time point divided by VEGF-C concentration at baseline (ratio to baseline).|Baseline to Cycle 3, Day 28 inclusive|ITT. Number of participants analyzed = number of subjects with soluble protein biomarkers at baseline. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point.||ratio||Standard Deviation|Mean
706264|NCT00113529|Secondary|VEGF-C Concentration at Baseline|Concentration of VEGF-C at baseline.|Baseline (Cycle 1, Day 1)|ITT. Number of participants analyzed = number of subjects with soluble protein biomarkers at baseline.||pg/mL||Standard Deviation|Mean
706265|NCT00113529|Secondary|VEGF Ratio to Baseline at Each Time Point|VEGF concentration at each time point divided by VEGF concentration at baseline (ratio to baseline).|Baseline to Cycle 3, Day 28 inclusive|ITT. Number of participants analyzed = number of subjects with soluble protein biomarkers at baseline. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point.||ratio||Standard Deviation|Mean
706266|NCT00113529|Secondary|VEGF (Vascular Endothelial Growth Factor) Concentration at Baseline|Concentration of VEGF at baseline.|Baseline (Cycle 1, Day 1)|ITT. Number of participants analyzed = number of subjects with soluble protein biomarkers at baseline.||pg/mL||Standard Deviation|Mean
706268|NCT00113529|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time from the date of first dose of study medication to the date of first documentation of tumor progression or death due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. PFS (in weeks) was calculated as (first event date minus first dose date +1)/7. Kaplan-Meier method was used.|From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter or death|ITT. Number of participants analyzed = those who progressed or died due to any cause while on study.||weeks||95% Confidence Interval|Median
706269|NCT00113529|Secondary|Overall Survival (OS)|OS was defined as the time from date of the first dose of study medication to date of death due to any cause. OS (in weeks) is calculated as (date of death minus first dose date +1)/7. For subjects not expiring, their survival times were censored at the last date of known contact they were known to be alive. Subjects lacking data beyond the day of first dose had their survival times censored at 1 day. Kaplan-Meier method was used.|From start of study treatment until death|ITT. Number of participants analyzed = subjects who died.||weeks||Full Range|Median
706270|NCT00113529|Secondary|Time to Tumor Progression (TTP)|TTP was defined as the time from the date of first dose of study medication to first documentation of objective tumor progression. If tumor progression data included more than 1 date, the first date was used. TTP (in weeks) was calculated as (first event date minus first dose date +1)/7. Kaplan-Meier method was used.|From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter|ITT. Number of participants analyzed = those who progressed on study.||weeks||95% Confidence Interval|Median
706271|NCT00113529|Secondary|Duration of Response (DR)|DR was defined as the time from start of the first documentation of objective tumor response to the first documentation of objective tumor progression or death due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. DR was calculated as (the end date for DR minus first CR or PR that was subsequently confirmed +1)/7. DR was calculated for the subgroup of subjects with an objective tumor response (CR or PR).|From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter or death due to cancer|ITT. Number of participants analyzed = those who had a response and subsequent progression or death due to any cause while on study.||weeks||Full Range|Median
706272|NCT00113529|Secondary|Time to Tumor Response (TTR)|TTR was defined as the time from date of the first dose of study medication to first documentation of objective tumor response (CR or PR). For subjects proceeding from PR to CR, the onset of PR was taken as the onset of response. If lesion assessment data included more than 1 date, the first date was used. TTR was calculated as (first event date minus first dose date +1)/7. TTR was calculated based on the subgroup of subjects with a baseline disease assessment, who had the correct histological cancer type, and had a confirmed objective tumor response. Kaplan-Meier method was used.|From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter|ITT. Number of participants analyzed = those who had a confirmed response on study.||weeks||95% Confidence Interval|Median
706273|NCT00113529|Primary|Number of Subjects With Overall Confirmed Objective Disease Response According to the Response Evaluation Criteria in Solid Tumors (RECIST)|Objective disease response = subjects with confirmed complete response (CR) or partial response (PR) according to RECIST. A CR was defined as the disappearance of all target lesions. A PR was defined as a ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter|Intent-to-treat (ITT) = all subjects enrolled in the study that received at least 1 dose of study medication (sunitinib or gefitinib).||participants|||Number
706274|NCT00113568|Primary|Number of Subjects Who Died During the Study|Number of subjects who died, for any reason, during the study|Up to 27 menstrual cycles|||participants|||Number
706275|NCT00113568|Primary|Number of Subjects With Any Thrombotic or Thromboembolic Adverse Event During the Study|Examples include deep vein thrombosis, pulmonary embolism, cerebral thrombosis, acute renal cortical necrosis, central retinal artery and vein obstruction.|Up to 27 menstrual cycles|intent to treat population||participants|||Number
706276|NCT00113568|Primary|Number of Subjects With Adverse Events That Led to Discontinuation From the Study|The total number of subjects who withdrew from the study due to an adverse event irrespective of the causal relation between the AE and the study drug as determined by the investigator|Up to 27 menstrual cycles|||participants|||Number
706277|NCT00113568|Primary|Number of Subjects With at Least One Life-Threatening Adverse Event During the Study|A life-threatening AE is any AE that places the subject at immediate risk of death from the event as it occurred.|Up to 27 menstrual cycles|intent to treat population||participants|||Number
706278|NCT00113568|Primary|Number of Subjects With at Least One Serious Adverse Event During the Study|A serious adverse event (SAE) is any adverse event (AE) occurring at any dose that meets 1 or more of the following criteria: results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in a persistent or significant disability or incapacity; results in cancer; results in a congenital anomaly or birth defect. Important medical events not described above may be considered SAEs when based on appropriate medical judgment.|Up to 27 menstrual cycles|intent to treat population||participants|||Number
706279|NCT00113568|Primary|Number of Subjects With at Least One Definitely Treatment-Related Adverse Event During the Study|The causal relation between an adverse event and the study drug was determined by the investigator on the basis of his or her clinical judgment. A definitely treatment-related adverse event is an event that can be fully explained by administration of the study drug.|Up to 27 menstrual cycles|intent to treat population||participants|||Number
706280|NCT00113568|Primary|Number of Subjects With at Least One Probably Treatment-Related Adverse Event During the Study|The causal relation between an adverse event and the study drug was determined by the investigator on the basis of his or her clinical judgment. A probably treatment-related adverse event is an event most likely to be explained by administration of the study drug rather than the subjects's clinical state or other agents/therapies.|Up to 27 menstrual cycles|intent to treat population||participants|||Number
706281|NCT00113568|Primary|Number of Subjects With at Least One Possibly Treatment-Related Adverse Event During the Study|The causal relation between an adverse event and the study drug was determined by the investigator on the basis of his or her clinical judgment. A possibly treatment-related adverse event is an event that may be explained by administration of the study drug or by the subjects's clinical state or other agents/therapies.|Up to 27 menstrual cycles|intent to treat population||participants|||Number
706282|NCT00113568|Primary|Number of Subjects With at Least One Adverse Event During the Study|An adverse event is any untoward, undesired, unplanned clinical event in the form of signs. symptoms, disease, or laboratory or physiological observations occurring in a human being participating in a clinical study with a sponsor study drug, regardless of causal relationship.|Up to 27 menstrual cycles|intent to treat population||participants|||Number
706283|NCT00113607|Secondary|Median Maximum Plasma Concentration (Cmax) of Trabectedin.|Median simulated maximum plasma concentration (Cmax) at 3 hour of a 21 day trabectedin profile of participants (of this study) administering trabectedin and doxil. The assessment of Cmax was based on a dataset created of 1000 participants using the posthoc parameter estimations, derived from the population pharmacokinetic analysis dataset of Trabectedin (participants=831, with resampling). Plasma concentration-time profiles were simulated up to 504 hour post-dosing using a rich sampling.|Day 1 (Predose; 1.5 hour after start of infusion; 5 minutes, 2 hour and 6 to 20 hour after end of infusion); Day 8 (168 hour after end of infusion); and Day 15 (336 hour after end of infusion) at Cycles 1 and 2|Blood samples for pharmacokinetic analysis were collected from 86 participants of this study.||pg/mL|||Number
706284|NCT00113607|Secondary|Median Area Under Curve (AUC) of Trabectedin.|Median simulated area under the curve (AUC) of a 21 day trabectedin profile of participants (of this study) administering trabectedin and doxil, calculated using the trapezoidal rule method. Simulations were based on a dataset created of 1000 participants using the posthoc parameter estimations, derived from the population pharmacokinetic analysis dataset of Trabectedin (Participants=831, with resampling). Plasma concentration-time profiles were simulated up to 504 hour post-dosing using a rich sampling.|Day 1 (Predose; 1.5 hour after start of infusion; 5 minutes, 2 hour and 6 to 20 hour after end of infusion); Day 8 (168 hour after end of infusion); and Day 15 (336 hour after end of infusion) at Cycles 1 and 2|Blood samples for pharmacokinetic analysis were collected from 86 participants of this study.||ng*h/mL|||Number
706285|NCT00113607|Secondary|Duration of Response: Independent Radiologist Review|Duration of response was defined only for participants who had complete response or partial response as best overall response. Duration of response was calculated from the date of first documentation of response (not the confirmation) to the date of disease progression or death due to progressive disease.|From the date of first documentation of response to the date of disease progression or death due to progressive disease, as assessed for approximately 3 years|All Responders (CR/PR) Analysis Participants: all participants who achieved CR or PR as best overall response during the study.||Months||95% Confidence Interval|Median
706286|NCT00113607|Secondary|Objective Response Rate (ORR) - Independent Radiologist Review|Percentage of participants who achieved complete response (CR) or partial response (PR) as best overall response. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR) = Disappearance of all target lesions; Partial Response (PR)= greater than or equal to 30% decrease in the sum of the longest diameter of target lesions and Overall Response (OR) = CR + PR.|From the date of randomization until the date of disease progression or death, as assessed for approximately 3 years|All Randomized Analysis Participants: all participants who were randomized to this study, independent of whether they received study medication or not.||Percentage of participants|||Number
706287|NCT00113607|Secondary|Overall Survival|Overall survival was defined as the time between the randomization and death|From the date of randomization until the date of death, as assessed for approximately 3 years|All Randomized Analysis Participants: all participants who were randomized to this study, independent of whether they received study medication or not||Months||95% Confidence Interval|Median
706288|NCT00113607|Primary|Progression-Free Survival (PFS): Independent Radiologist Review|PFS is defined as the time between randomization and disease progression or death.|From the date of randomization until the date of disease progression or death, as assessed for approximately 3 years|All Measurable Analysis Participants: All randomized participants who had measurable disease at baseline as assessed by the independent radiology review. Measurable disease is defined as having at least 1 lesion measured with a diameter of ≥20 mm using conventional techniques or of ≥10 mm using a spiral computerized tomography scan.||Months||95% Confidence Interval|Median
706293|NCT00114127|Secondary|CGI-S|"The Clinician Global Impression-Severity Scale (CGI-S) is a clinician-rated instrument used to assess global severity of symptoms (Guy, 1976). The CGI ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Baseline collected for Phase 1 at week 0 and for Phase 2 at week 6."|6 months|||Scores on a scale||Standard Error|Mean
706294|NCT00114127|Primary|Anxiety Symptoms as Assessed by Liebowitz Social Anxiety Scale|The Liebowitz Social Anxiety Scale (LSAS; Liebowitz, 1987) is a 24-item scale that provides separate scores for fear and avoidance in social and performance situations with higher scores representing increased social anxiety. The LSAS contains three total scores: 1) total fear score (0-72), 2) total avoidance score(0-72), 3) and total overall score (0-144). Suggested interpretations: 55-65 Moderate social phobia, 65-80 Marked social phobia, 80-95 Severe social phobia, Greater than 95 - Very severe social phobia.|6 months|||Scores on a scale||Standard Error|Mean
706295|NCT00114166|Secondary|Reason Off Study Therapy||study entry through end of study treatment|Total number of eligible and evaluable participants||participants|||Number
706296|NCT00114166|Primary|Frequency and Severity of Observed Adverse Effects||Study entry through disease progression or study withdrawal||||||
706297|NCT00114166|Primary|Objective Tumor Response|"Response is measured according to Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.0):
Complete Response (CR) is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart.
Partial Response (PR) is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD.
Disease Progression is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.
Stable Disease is any condition not meeting the above criteria.
Indeterminate is defined as having no repeat tumor assessments following initiation of study therapy for reasons unrelated to symptoms or signs of disease."|Every other cycle for the first 6 months, then every 3 months x2, then every 6 months until disease progression or study withdrawal|Total number eligible and evaluable participants||participants|||Number
706298|NCT00114244|Secondary|Progression-free Survival|Estimated using the product-limit method of Kaplan and Meier by arm. The probability of progression-free survival at 3 months and overall survival at 6 months, and their Greenwood’s standard errors will be summarized by arm.|From first day of treatment to the first observation of disease progression or death due to any cause, assessed up to 3 months|||Months||95% Confidence Interval|Median
706299|NCT00114244|Secondary|Overall Survival|Estimated using the product-limit method of Kaplan and Meier by arm.|From first day of treatment to time of death due to any cause, assessed up to 6 months|||Months||95% Confidence Interval|Median
706300|NCT00114244|Primary|Objective Response (OR = CR or PR) as Determined by the RECIST Criteria|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan, MRI, X-ray: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Every 6 weeks.|||participants|||Number
706301|NCT00114504|Secondary|Circulating Inflammation Marker|Change in circulating hsCRP levels|Baseline, 3 months|||mg/dL||Standard Deviation|Mean
706302|NCT00114504|Primary|Plaque Inflammation|Change in plaque inflammation was assessed by changes in the plaque SUV.|Baseline, 3 months|||SUV||Standard Deviation|Mean
706303|NCT00114517|Secondary|Number of Participants With Coronary Artery Calcium Measured by Cardiac Computed Tomography|measurement of coronary artery calcium at end of study|End of randomized treatment|CAC data was obtained in 380 participants. Participants who were not taking the study agents at the last follow-up visit, who had adherence to the study regimen that was lower than 80% or who had a CAC scan more than 6 months after the final study visit were not included in the analysis.||Participants|||Count of Participants
706304|NCT00114517|Secondary|Change in Neurocognitive Function (Global Cognition)|All neuropsychological test scores at baseline and follow-up assessments were standardized ([raw score – mean score]/standard deviation) using the baseline means and standard deviations from the entire ELITE sample. Each of three cognitive composite scores was calculated at baseline and follow-up assessments as the weighted average of the individual donor standardized test scores, weighted by the inverse correlation among tests.The change from baseline (endpoint minus baseline cognitive outcome) was computed for each of the cognitive scores (verbal memory, global cognition, and executive functions). Since the outcome is not a single test but a weighted average of multiple tests, the range is not standard and not reported. Higher scores mean better outcomes.|Baseline and at 2.5 years and 5 years|Early postmenopause group (<6 years since menopause) at baseline and late postmenopause group (>10 years since menopause) at baseline. Sample size represents the number of participants with analyzable data collected at baseline, 2.5 years and 5.0 years.||units on a scale||95% Confidence Interval|Mean
706305|NCT00114517|Primary|Rate of Change of Distal Common Carotid Artery (CCA) Far Wall Intima-media Thickness (IMT)||Twice at baseline and then every 6 months on trial|Early postmenopause group (<6 years since menopause) at baseline and late postmenopause group (>10 years since menopause) at baseline.||mm per year||95% Confidence Interval|Mean
706306|NCT00114530|Secondary|Time to Absolute Neutrophil Count Engraftment|Time to absolute neutrophil count (ANC) engraftment is defined as the number of days post-transplant until required levels of ANC are attained (for the mHSCT arm only). If engraftment did not occur within 28 days post-transplant, then the variable was set to 28 days. ANC engraftment required an ANC of > 500 cells/microliter, maintained for 3 consecutive days.|28 days post-transplant|Per-protocol (PP) – mHSCT arm only. The PP population is defined as those participants who completed the assigned treatment protocol: undergoing autologous CD34-selected hematopoietic progenitor cell transplantation in the mHSCT arm.||Days||Full Range|Median
706307|NCT00114530|Secondary|Number of Subjects With Infectious Complications|Infectious complications include any events that code to the Medical Dictionary for Regulatory Activities (MedDRA) system organ class of “Infections and infestations” or events that a site has classified as an infectious event. These can include bacteremia, septicemia, fungemia, fever associated with infection, infectious pneumonia, idiopathic pneumonia syndrome, clinical infection (i.e. infection diagnosed with clinical features without identification of an organism) and other local/organ site-specific infections.|Randomization through end of study follow-up (up to Month 72 post-randomization).|Safety population. The safety population includes all participants for whom study treatment was initiated. For the mHSCT arm, treatment was initiated with the first dose of granulocyte colony stimulating factor for mobilization, and for the cyclophosphamide arm, treatment was initiated with the first dose of IV cyclophosphamide.||Participants|||Count of Participants
707003|NCT00118365|Secondary|Biomarker in Adenoma: CEA|carcino-embryonic antigen (CEA) is adenocarcinoma tissue marker that is expressed during adenoma formation.|At the end of the study|The analysis cohort is based on the participants whose data are available.||Adenoma|Participants||Number
706308|NCT00114530|Secondary|Infectious Complications|Infectious complications include any events that code to the Medical Dictionary for Regulatory Activities (MedDRA) system organ class of “Infections and infestations” or events that a site has classified as an infectious event. These can include bacteremia, septicemia, fungemia, fever associated with infection, infectious pneumonia, idiopathic pneumonia syndrome, clinical infection (i.e. infection diagnosed with clinical features without identification of an organism) and other local/organ site-specific infections.|Randomization through end of study follow-up (up to Month 72 post-randomization).|Safety population. The safety population includes all participants for whom study treatment was initiated. For the mHSCT arm, treatment was initiated with the first dose of granulocyte colony stimulating factor for mobilization, and for the cyclophosphamide arm, treatment was initiated with the first dose of IV cyclophosphamide.||Events|||Number
706309|NCT00114530|Secondary|Number of Subjects With Regimen-Related Toxicities|Regimen-related toxicities are defined as Grade 3 or higher adverse events reported by site physicians as possibly, probably, or definitely related to study therapy.|Randomization through end of study follow-up (up to Month 72 post-randomization).|Safety population. The safety population includes all participants for whom study treatment was initiated. For the mHSCT arm, treatment was initiated with the first dose of granulocyte colony stimulating factor for mobilization, and for the cyclophosphamide arm, treatment was initiated with the first dose of IV cyclophosphamide.||Participants|||Count of Participants
706310|NCT00114530|Secondary|Regimen-Related Toxicities|Regimen-related toxicities are defined as Grade 3 or higher adverse events reported by site physicians as possibly, probably, or definitely related to study therapy.|Randomization through end of study follow-up (up to Month 72 post-randomization)|Safety population. The safety population includes all participants for whom study treatment was initiated. For the mHSCT arm, treatment was initiated with the first dose of granulocyte colony stimulating factor for mobilization, and for the cyclophosphamide arm, treatment was initiated with the first dose of IV cyclophosphamide.||Events|||Number
706311|NCT00114530|Secondary|Initiating Use of Disease-Modifying Antirheumatic Drugs by Month 54 (DMARDs) (PP)|Initiation of disease-modifying antirheumatic drugs (DMARDs). Participants were not expected to receive additional disease-modifying therapy for systemic sclerosis (SSc) in the absence of disease progression. In general, this includes the administration of any therapy clearly given for the purpose of treating the underlying SSc. It does not include concomitant treatments permitted in the protocol, such as use of methotrexate (15 g or less), anti-malarials, or minocycline for arthritis only. Systemic corticosteroids given at > 10 mg/day (prednisone or prednisone equivalent), without clearly defined non-SSc indications, and methotrexate given for non-arthritis indications are examples of qualifying DMARDs.|54 Months Post-Randomization|Per-protocol (PP). The PP population is defined as those participants who completed the assigned treatment protocol: undergoing autologous CD34-selected hematopoietic progenitor cell transplantation in the mHSCT arm, or receiving at least 9 of 12 planned doses in the cyclophosphamide arm.||Participants|||Count of Participants
706312|NCT00114530|Secondary|Initiating Use of Disease-Modifying Antirheumatic Drugs (DMARDs) by Month 54 (ITT)|Initiation of disease-modifying antirheumatic drugs (DMARDs). Participants were not expected to receive additional disease-modifying therapy for systemic sclerosis (SSc) in the absence of disease progression. In general, this includes the administration of any therapy clearly given for the purpose of treating the underlying SSc. It does not include concomitant treatments permitted in the protocol, such as use of methotrexate (15 g or less), anti-malarials, or minocycline for arthritis only. Systemic corticosteroids given at > 10 mg/day (prednisone or prednisone equivalent), without clearly defined non-SSc indications, and methotrexate given for non-arthritis indications are examples of qualifying DMARDs.|54 Months Post-Randomization|Intention to treat (ITT). The ITT population includes all randomized participants.||Participants|||Count of Participants
706313|NCT00114530|Secondary|Documented Myositis (PP)|Number of participants who experienced any event of myositis that occurred from randomization to Month 54 post-randomization. Documented myositis occurred if the participant had 1) elevated creatine phosphokinase (CPK), electromyography, and/or biopsy and 2) required > 30 mg per day prednisone for over 1 month or another therapy such as methotrexate (MTX) for treatment of myositis. Additionally, any adverse event reported as myositis was included in the analysis.|54 Months Post-Randomization|Per-protocol (PP). The PP population is defined as those participants who completed the assigned treatment protocol: undergoing autologous CD34-selected hematopoietic progenitor cell transplantation in the mHSCT arm, or receiving at least 9 of 12 planned doses in the cyclophosphamide arm.||Participants|||Count of Participants
706314|NCT00114530|Secondary|Documented Myositis (ITT)|Number of participants who experienced any event of myositis that occurred from randomization to Month 54 post-randomization. Documented myositis occurred if the participant had 1) elevated creatine phosphokinase (CPK), electromyography, and/or biopsy and 2) required > 30 mg per day prednisone for over 1 month or another therapy such as methotrexate (MTX) for treatment of myositis. Additionally, any adverse event reported as myositis was included in the analysis.|54 Months Post-Randomization|Intention to treat (ITT). The ITT population includes all randomized participants.||Participants|||Count of Participants
706315|NCT00114530|Secondary|Occurrence of Scleroderma Renal Crisis (PP)|Documented scleroderma renal crisis (hypertensive or non-hypertensive) occurring from randomization to Month 54 post-randomization was summarized. A hypertensive scleroderma renal crisis occurred if a participant obtained both of the following: New-onset hypertension, defined as systolic blood pressure (SBP) >= 140 mmHg, diastolic blood pressure (DBP) >= 90 mmHg, a rise in SBP >= 30 mmHg compared to baseline, or a rise in DBP >= 20 mmHg compared to baseline, and one of the following features: 1) increase of >= 50 % above baseline in serum creatinine, 2) proteinuria (>= 2+ by dipstick confirmed by protein:creatinine ratio > 2.5), 3) hematuria (>= 2+ by dipstick or > 10 RBCs/HPF, without menstruation), 4) thrombocytopenia (< 100,000 plts/mm3), or 5) hemolysis (determined by blood smear or increased reticulocyte count). Additionally, any adverse event reported as a scleroderma renal crisis was included in the analysis.|54 Months Post-Randomization|Per-protocol (PP). The PP population is defined as those participants who completed the assigned treatment protocol: undergoing autologous CD34-selected hematopoietic progenitor cell transplantation in the mHSCT arm, or receiving at least 9 of 12 planned doses in the cyclophosphamide arm.||Participants|||Count of Participants
706316|NCT00114530|Secondary|Occurrence of Scleroderma Renal Crisis (ITT)|Documented scleroderma renal crisis (hypertensive or non-hypertensive) occurring from randomization to Month 54 post-randomization was summarized. A hypertensive scleroderma renal crisis occurred if a participant obtained both of the following: New-onset hypertension, defined as systolic blood pressure (SBP) >= 140 mmHg, diastolic blood pressure (DBP) >= 90 mmHg, a rise in SBP >= 30 mmHg compared to baseline, or a rise in DBP >= 20 mmHg compared to baseline, and one of the following features: 1) increase of >= 50 % above baseline in serum creatinine, 2) proteinuria (>= 2+ by dipstick confirmed by protein:creatinine ratio > 2.5), 3) hematuria (>= 2+ by dipstick or > 10 RBCs/HPF, without menstruation), 4) thrombocytopenia (< 100,000 plts/mm3), or 5) hemolysis (determined by blood smear or increased reticulocyte count). Additionally, any adverse event reported as a scleroderma renal crisis was included in the analysis.|54 Months Post-Randomization|Intention to treat (ITT). The ITT population includes all randomized participants.||Participants|||Count of Participants
706317|NCT00114530|Secondary|New or Worsening Pulmonary Hypertension (PP)|Any pulmonary arterial hypertension (PAH) events that occurred between randomization and Month 54 post-randomization were summarized. Development of PAH occurred if the participant met the following criteria, where the measurement value(s) could not be explained by other causes such as congestive heart failure or pulmonary emboli: 1) a post-baseline peak systolic pulmonary artery pressure > 55 mmHg by echocardiogram or 2) a mean pulmonary artery pressure > 30 mmHg at rest measured by right heart catheterization. If the post-baseline peak systolic pulmonary artery pressure was between 40 to 55 mmHg by echocardiogram, a right heart catheterization would be done to confirm a diagnosis of pulmonary artery hypertension. The endpoint was met if the mean pulmonary artery pressure was > 30 mmHg at rest by right heart catheterization. Additionally, any adverse event reported as PAH was included in the analysis.|54 Months Post-Randomization|Per-protocol (PP). The PP population is defined as those participants who completed the assigned treatment protocol: undergoing autologous CD34-selected hematopoietic progenitor cell transplantation in the mHSCT arm, or receiving at least 9 of 12 planned doses in the cyclophosphamide arm.||Participants|||Count of Participants
706318|NCT00114530|Secondary|New or Worsening Pulmonary Hypertension (ITT)|Any pulmonary arterial hypertension (PAH) events that occurred between randomization and Month 54 post-randomization were summarized. Development of PAH occurred if the participant met the following criteria, where the measurement value(s) could not be explained by other causes such as congestive heart failure or pulmonary emboli: 1) a post-baseline peak systolic pulmonary artery pressure > 55 mmHg by echocardiogram or 2) a mean pulmonary artery pressure > 30 mmHg at rest measured by right heart catheterization. If the post-baseline peak systolic pulmonary artery pressure was between 40 to 55 mmHg by echocardiogram, a right heart catheterization was done to confirm a diagnosis of pulmonary artery hypertension. The endpoint was met if the mean pulmonary artery pressure was > 30 mmHg at rest by right heart catheterization. Additionally, any adverse event reported as PAH was included in the analysis.|54 Months Post-Randomization|Intention to treat (ITT). The ITT population includes all randomized participants.||Participants|||Count of Participants
706319|NCT00114530|Secondary|New or Worsening Arrhythmias, Congestive Heart Failure, or Pericardial Effusion (PP)|Any events that met the criteria outlined below or were reported as adverse events between randomization and Month 54 post-randomization are summarized. 1) Development of new or worsening arrhythmias that require medical treatment for >= 3 months or require ablative therapy or pacemaker insertion. (Note that for a participant who has medically controlled arrhythmia at randomization, worsening will be defined as breakthrough episodes severe enough to prompt change in medication, an increase in the dose of a medication or addition of a new medication to maintain control of the arrhythmia.) 2) Congestive heart failure (CHF) requiring clinical treatment for >= 3 months develops. 3) Clinically significant pericardial effusion (excess fluid around the heart) that required pericardial window.|54 Months Post-Randomization|Per-protocol (PP). The PP population is defined as those participants who completed the assigned treatment protocol: undergoing autologous CD34-selected hematopoietic progenitor cell transplantation in the mHSCT arm, or receiving at least 9 of 12 planned doses in the cyclophosphamide arm.||Participants|||Count of Participants
706320|NCT00114530|Secondary|New or Worsening Arrhythmias, Congestive Heart Failure, or Pericardial Effusion (ITT)|Any events that met the criteria outlined below or were reported as adverse events between randomization and Month 54 post-randomization are summarized. 1) Development of new or worsening arrhythmias that require medical treatment for >= 3 months or require ablative therapy or pacemaker insertion. (Note that for a participant who has medically controlled arrhythmia at randomization, worsening was defined as breakthrough episodes severe enough to prompt change in medication, an increase in the dose of a medication, or addition of a new medication to maintain control of the arrhythmia.) 2) Congestive heart failure (CHF) requiring clinical treatment for >= 3 months develops. 3) Clinically significant pericardial effusion (excess fluid around the heart) that required pericardial window.|54 Months Post-Randomization|Intention to treat (ITT). The ITT population includes all randomized participants.||Participants|||Count of Participants
706321|NCT00114530|Secondary|Change From Baseline to Month 54 in Modified Rodnan Skin Score (mRSS) (PP)|The Modified Rodnan Skin Score (mRSS) is a measure of skin thickness. Skin thickness in 17 anatomic areas was rated on a 0-3 scale and scores are summed to obtain the mRSS (range from 0 - 51), with higher mRSS scores indicating worse disease activity. Analysis was based on an ordinal response variable, defined as follows: if the baseline mRSS was <=20, a decrease >=5 points from baseline indicated disease improvement and an increase >= 5 points indicated disease worsening; if the baseline mRSS was >20, then a decrease of >25% indicated disease improvement and an increase of >25% indicated disease worsening. Participants who do not meet the disease criteria outlined above were considered “no change”. Data for participants without a Month 54 assessment was imputed using a last observation carried forward approach; improvement/worsening was assessed at each participant's last available study visit that occurred prior to or at Month 54, without confirmation at the next visit.|54 Months Post-Randomization|Per-protocol (PP). The PP population is defined as those participants who completed the assigned treatment protocol: undergoing autologous CD34-selected hematopoietic progenitor cell transplantation in the mHSCT arm, or receiving at least 9 of 12 planned doses in the cyclophosphamide arm.||Participants|||Count of Participants
706386|NCT00114972|Secondary|Freedom From MACCE and Its Components at 1 Year Post-allocation.|Number of participants with freedom from MACCE and its components at 1 year post-allocation. Freedom from MACCE is defined as no MACCE nor any of the individual components of MACCE (all cause death, stroke, documented myocardial infarction, repeat revascularization).|1 year post allocation|||participants|||Number
706322|NCT00114530|Secondary|Change From Baseline to Month 54 in Modified Rodnan Skin Score (mRSS) (ITT)|The Modified Rodnan Skin Score (mRSS) is a measure of skin thickness. Skin thickness in 17 anatomic areas was rated on a 0-3 scale and scores are summed to obtain the mRSS (range from 0 - 51), with higher mRSS scores indicating worse disease activity. Analysis was based on an ordinal response variable, defined as follows: if the baseline mRSS was <=20, a decrease >=5 points from baseline indicated disease improvement and an increase >= 5 points indicated disease worsening; if the baseline mRSS was >20, then a decrease of >25% indicated disease improvement and an increase of >25% indicated disease worsening. Participants who do not meet the disease criteria outlined above were considered “no change”. Data for participants without a Month 54 assessment was imputed using a last observation carried forward approach; improvement/worsening was assessed at each participant's last available study visit that occurred prior to or at Month 54, without confirmation at the next visit.|54 Months Post-Randomization|Intention to treat (ITT). The ITT population includes all randomized participants.||Participants|||Count of Participants
706323|NCT00114530|Secondary|Change From Baseline to Month 54 in Forced Vital Capacity (FVC) (PP)|Forced Vital Capacity (FVC) is the amount of air that can be forcibly exhaled after a full breath and is a measure of lung function. Predicted FVC was based on institutional standards. Analysis was based on an ordinal response variable, defined as follows: an increase from baseline of >10% in FVC % Predicted indicated disease improvement, a decrease of >10% indicated disease worsening, and a change of <=10% was considered “no change”. Data for participants without a Month 54 assessment was imputed using a last observation carried forward approach; improvement/worsening was assessed at each participant's last available study visit that occurred prior to or at Month 54, without confirmation at the next visit.|54 Months Post-Randomization|Per-protocol (PP). The PP population is defined as those participants who completed the assigned treatment protocol: undergoing autologous CD34-selected hematopoietic progenitor cell transplantation in the mHSCT arm, or receiving at least 9 of 12 planned doses in the cyclophosphamide arm.||Participants|||Count of Participants
706324|NCT00114530|Secondary|Change From Baseline to Month 54 in Forced Vital Capacity (FVC) (ITT)|Forced Vital Capacity (FVC) is the amount of air that can be forcibly exhaled after a full breath and is a measure of lung function. Predicted FVC was based on institutional standards. Analysis was based on an ordinal response variable, defined as follows: an increase from baseline of >10% in FVC % Predicted indicated disease improvement, a decrease of >10% indicated disease worsening, and a change of <=10% was considered “no change”. Data for participants without a Month 54 assessment was imputed using a last observation carried forward approach; improvement/worsening was assessed at each participant's last available study visit that occurred prior to or at Month 54, without confirmation at the next visit.|54 Months Post-Randomization|Intention to treat (ITT). The ITT population includes all randomized participants.||Participants|||Count of Participants
706325|NCT00114530|Secondary|Change From Baseline to Month 54 in Diffusion in Liters of Carbon Monoxide (DLCO) (PP)|Diffusion in liters of carbon monoxide (DLCO) is a measure of lung function. Predicted values for DLCO were computed using the Crapo Morris equations and adjusted per the Cotes formula for anemia, if a participant’s hemoglobin was <13 or >17 gm/dL, and altitude (Calgary site only). Analysis was based on an ordinal response variable, defined as follows: an increase from baseline of >15% in DLCO % Predicted indicated disease improvement, a decrease of >15% indicated disease worsening, and a change of <=15% was considered “no change”. Data for participants without a Month 54 assessment was imputed using a last observation carried forward approach; improvement/worsening was assessed at each participant's last available study visit that occurred prior to or at Month 54, without confirmation at the next visit.|54 Months Post-Randomization|Per-protocol (PP). The PP population is defined as those participants who completed the assigned treatment protocol: undergoing autologous CD34-selected hematopoietic progenitor cell transplantation in the mHSCT arm, or receiving at least 9 of 12 planned doses in the cyclophosphamide arm.||Participants|||Count of Participants
706326|NCT00114530|Secondary|Change From Baseline to Month 54 in Diffusion in Liters of Carbon Monoxide (DLCO) (ITT)|Diffusion in liters of carbon monoxide (DLCO) is a measure of lung function. Predicted values for DLCO were computed using the Crapo Morris equations and adjusted per the Cotes formula for anemia, if a participant’s hemoglobin was <13 or >17 gm/dL, and altitude (Calgary site only). Analysis was based on an ordinal response variable, defined as follows: an increase from baseline of >15% in DLCO % Predicted indicated disease improvement, a decrease of >15% indicated disease worsening, and a change of <=15% was considered “no change”. Data for participants without a Month 54 assessment was imputed using a last observation carried forward approach; improvement/worsening was assessed at each participant's last available study visit that occurred prior to or at Month 54, without confirmation at the next visit.|54 Months Post-Randomization|Intention to treat (ITT). The ITT population includes all randomized participants.||Participants|||Count of Participants
706327|NCT00114530|Secondary|Change From Baseline to Month 54 in Short Form 36 Health Survey (SF-36) (PP)|The SF-36 measures health-related quality of life. It has 36 items and 2 component scores, the Physical Component Score and the Mental Component Score. Each component was transformed into a 0-100 scale (higher numbers indicate greater quality of life) and normalized to have a mean of 50 and standard deviation of 10 for the 1998 general US population. Analysis was based on ordinal response, defined as follows for each component: a >= 10 point increase indicated disease improvement, a >= 10 point decrease indicated disease worsening, and a change <10 points indicated “no change”. Data for participants without a Month 54 assessment was imputed using a last observation carried forward approach; improvement/worsening was assessed at each participant's last available study visit that occurred prior to or at Month 54, without confirmation at the next visit.|54 Months Post-Randomization|Per-protocol (PP). The PP population is defined as those participants who completed the assigned treatment protocol: undergoing autologous CD34-selected hematopoietic progenitor cell transplantation in the mHSCT arm, or receiving at least 9 of 12 planned doses in the cyclophosphamide arm.||Participants|||Count of Participants
710936|NCT00168844|Secondary|Change From Baseline in Lymphocytes|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||percentage of white blood cell count||Standard Deviation|Mean
706328|NCT00114530|Secondary|Change From Baseline to Month 54 in Short Form 36 Health Survey (SF-36) (ITT)|The SF-36 measures health-related quality of life. It has 36 items and 2 component scores, the Physical Component Score and the Mental Component Score. Each component was transformed into a 0-100 scale (higher numbers indicate greater quality of life) and normalized to have a mean of 50 and standard deviation of 10 for the 1998 general US population. Analysis was based on ordinal response, defined as follows for each component: a >= 10 point increase indicated disease improvement, a >= 10 point decrease indicated disease worsening, and a change <10 points indicated “no change”. Data for participants without a Month 54 assessment was imputed using a last observation carried forward approach; improvement/worsening was assessed at each participant's last available study visit that occurred prior to or at Month 54, without confirmation at the next visit.|54 Months Post-Randomization|Intention to treat (ITT). The ITT population includes all randomized participants.||Participants|||Count of Participants
706329|NCT00114530|Secondary|Change From Baseline to Month 54 in Health Assessment Questionnaire - Disability Index (HAQ-DI) (PP)|HAQ-DI is a self-reported questionnaire of functionality that includes questions in 8 domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities). The final score ranges from 0 to 3, where a higher HAQ-DI score indicates a worse outcome. Analysis was based on an ordinal response variable, defined as follows: a decrease of >0.4 from baseline in the HAQ-DI score was considered disease improvement, an increase of >0.4 was considered disease worsening, and any change less than 0.4 was considered “no change.” Data for participants without a Month 54 assessment was imputed using a last observation carried forward approach; improvement/worsening was assessed at each participant's last available study visit that occurred prior to or at Month 54, without confirmation at the next visit.|54 Months Post-Randomization|Per-protocol (PP). The PP population is defined as those participants who completed the assigned treatment protocol: undergoing autologous CD34-selected hematopoietic progenitor cell transplantation in the mHSCT arm, or receiving at least 9 of 12 planned doses in the cyclophosphamide arm.||Participants|||Count of Participants
706330|NCT00114530|Secondary|Change From Baseline to Month 54 in Health Assessment Questionnaire - Disability Index (HAQ-DI) (ITT)|HAQ-DI is a self-reported questionnaire of functionality that includes questions in 8 domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities). The final score ranges from 0 to 3, where a higher HAQ-DI score indicates a worse outcome. Analysis was based on an ordinal response variable, defined as follows: a decrease of >0.4 from baseline in the HAQ-DI score was considered disease improvement, an increase of >0.4 was considered disease worsening, and any change less than 0.4 was considered “no change.” Data for participants without a Month 54 assessment was imputed using a last observation carried forward approach; improvement/worsening was assessed at each participant's last available study visit that occurred prior to or at Month 54, without confirmation at the next visit.|54 Months Post-Randomization|Intention to treat (ITT). The ITT population includes all randomized participants.||Participants|||Count of Participants
706331|NCT00114530|Secondary|All-Cause Mortality (Month 48, PP)|Any death, regardless of relationship to treatment, between randomization and Month 48 post-randomization.|48 Months Post-Randomization|Per-protocol (PP). The PP population is defined as those participants who completed the assigned treatment protocol: undergoing autologous CD34-selected hematopoietic progenitor cell transplantation in the mHSCT arm, or receiving at least 9 of 12 planned doses in the cyclophosphamide arm||Participants|||Count of Participants
706332|NCT00114530|Secondary|All-Cause Mortality (Month 48, ITT)|Any death, regardless of relationship to treatment, between randomization and Month 48 post-randomization.|48 Months Post-Randomization|Intention to treat (ITT). The ITT population includes all randomized participants.||Participants|||Count of Participants
706333|NCT00114530|Secondary|All-Cause Mortality (Month 54, PP)|Any death, regardless of relationship to treatment, between randomization and Month 54 post-randomization.|54 Months Post-Randomization|Per-protocol (PP). The PP population is defined as those participants who completed the assigned treatment protocol: undergoing autologous CD34-selected hematopoietic progenitor cell transplantation in the mHSCT arm, or receiving at least 9 of 12 planned doses in the cyclophosphamide arm||Participants|||Count of Participants
706334|NCT00114530|Secondary|All-Cause Mortality (Month 54, ITT)|Any death, regardless of relationship to treatment, between randomization and Month 54 post-randomization.|54 Months Post-Randomization|Intention to treat (ITT). The ITT population includes all randomized participants.||Participants|||Count of Participants
706335|NCT00114530|Secondary|Treatment-Related Mortality (Month 48, PP)|Death, occurring at any time between randomization and Month 48 post-randomization, which is possibly, probably, or definitely resulting from treatment given in the study.|48 Months Post-Randomization|Per-protocol (PP). The PP population is defined as those participants who completed the assigned treatment protocol: undergoing autologous CD34-selected hematopoietic progenitor cell transplantation in the mHSCT arm, or receiving at least 9 of 12 planned doses in the cyclophosphamide arm.||Participants|||Count of Participants
706336|NCT00114530|Secondary|Treatment-Related Mortality (Month 48, ITT)|Death, occurring at any time between randomization and Month 48 post-randomization, which is possibly, probably, or definitely resulting from treatment given in the study.|48 Months Post-Randomization|Intention to treat (ITT). The ITT population includes all randomized participants.||Participants|||Count of Participants
706337|NCT00114530|Secondary|Treatment-Related Mortality (Month 54, PP)|Death, occurring at any time between randomization and Month 54 post-randomization, which is possibly, probably, or definitely resulting from treatment given in the study.|54 Months Post-Randomization|Per-protocol (PP). The PP population is defined as those participants who completed the assigned treatment protocol: undergoing autologous CD34-selected hematopoietic progenitor cell transplantation in the mHSCT arm, or receiving at least 9 of 12 planned doses in the cyclophosphamide arm.||Participants|||Count of Participants
706338|NCT00114530|Secondary|Treatment-Related Mortality (Month 54, ITT)|Death, occurring at any time between randomization and Month 54 post-randomization, which is possibly, probably, or definitely resulting from treatment given in the study.|54 Months Post-Randomization|Intention to treat (ITT). The ITT population includes all randomized participants.||Participants|||Count of Participants
706380|NCT00114972|Secondary|The Characteristics (Including Co-morbidity and Coronary Vascular Lesion Complexity Scoring Referred to as the SYNTAX Score) of the Following: PCI Versus CABG Randomized Cohort, PCI Registry Cohort (CABG Ineligible), CABG Registry Cohort (PCI Ineligible)||5 Years||||||
706381|NCT00114972|Secondary|Cost and Cost-effectiveness at 1, 3 and 5 Years Post-allocation||1 year, 3 and 5 years post allocation||||||
706339|NCT00114530|Secondary|Event-Free Survival (EFS) (Month 48, PP)|Event-free survival (EFS) is defined as survival without significant organ damage or death. EFS failure includes any one of the following: death, respiratory failure (decrease from baseline of >30% in DLCO % predicted or >20% in FVC % predicted, documented on at least 2 successive occasions at least 1 month apart), renal failure (requiring chronic dialysis > 6 months or transplantation), or the occurrence of cardiomyopathy (clinical congestive heart failure or left ventricular ejection fraction <30%, documented on at least 2 successive occasions at least 1 month apart). EFS failures include participants who failed any component of the EFS definition between randomization and Month 48 post-randomization.|48 Months Post-Randomization|Per-protocol (PP). The PP population is defined as those participants who completed the assigned treatment protocol: undergoing autologous CD34-selected hematopoietic progenitor cell transplantation in the mHSCT arm, or receiving at least 9 of 12 planned doses in the cyclophosphamide arm.||Participants|||Count of Participants
706340|NCT00114530|Secondary|Event-Free Survival (EFS) (Month 48, ITT)|Event-free survival (EFS) is defined as survival without significant organ damage or death. EFS failure includes any one of the following: death, respiratory failure (decrease from baseline of >30% in DLCO % predicted or >20% in FVC % predicted, documented on at least 2 successive occasions at least 1 month apart), renal failure (requiring chronic dialysis > 6 months or transplantation), or the occurrence of cardiomyopathy (clinical congestive heart failure or left ventricular ejection fraction <30%, documented on at least 2 successive occasions at least 1 month apart). EFS failures include participants who failed any component of the EFS definition between randomization and Month 48 post-randomization.|48 Months Post-Randomization|Intention to treat (ITT). The ITT population includes all randomized participants.||Participants|||Count of Participants
706341|NCT00114530|Secondary|Event-Free Survival (EFS) (Month 54, PP)|Event-free survival (EFS) is defined as survival without significant organ damage or death. EFS failure includes any one of the following: death, respiratory failure (decrease from baseline of >30% in DLCO % predicted or >20% in FVC % predicted, documented on at least 2 successive occasions at least 1 month apart), renal failure (requiring chronic dialysis > 6 months or transplantation), or the occurrence of cardiomyopathy (clinical congestive heart failure or left ventricular ejection fraction <30%, documented on at least 2 successive occasions at least 1 month apart). EFS failures include participants who failed any component of the EFS definition between randomization and Month 54 post-randomization.|54 Months Post-Randomization|Per-protocol (PP). The PP population is defined as those participants who completed the assigned treatment protocol: undergoing autologous CD34-selected hematopoietic progenitor cell transplantation in the mHSCT arm, or receiving at least 9 of 12 planned doses in the cyclophosphamide arm.||Participants|||Count of Participants
706342|NCT00114530|Secondary|Event-Free Survival (EFS) (Month 54, ITT)|Event-free survival (EFS) is defined as survival without significant organ damage or death. EFS failure includes any one of the following: death, respiratory failure (decrease from baseline of >30% in diffusion in liters of carbon monoxide (DLCO) % predicted or >20% in forced vital capacity (FVC) % predicted, documented on at least 2 successive occasions at least 1 month apart), renal failure (requiring chronic dialysis > 6 months or transplantation), or the occurrence of cardiomyopathy (clinical congestive heart failure or left ventricular ejection fraction <30%, documented on at least 2 successive occasions at least 1 month apart). EFS failures include participants who failed any component of the EFS definition between randomization and Month 54 post-randomization.|54 Months Post-Randomization|Intention to treat (ITT). The ITT population includes all randomized participants.||Participants|||Count of Participants
706343|NCT00114530|Secondary|Global Rank Composite Score (GRCS) (Month 48, PP)|The GRCS is an analytic tool that accounts for multiple disease manifestations simultaneously. It does not measure clinical disease activity or severity but reflects how participants compared to one another based on a hierarchy of ordered outcomes: death, event-free survival (EFS), forced vital capacity (FVC), Health Assessment Questionnaire - Disability Index (HAQ-DI), and Modified Rodnan Skin Score (mRSS). Participants alive ranked higher than those who died; those who survived event-free ranked higher than EFS failures. EFS failure included death, respiratory failure (decrease from baseline of >30% in DLCO % predicted or >20% in FVC % predicted ), renal failure (chronic dialysis > 6 month or renal transplant), or cardiac failure (clinical congestive heart failure or left ventricular ejection fraction <30%). The lowest 3 GRCS components are ordinal; improvement, stability, or worsening from baseline (±10% change in FVC % predicted, ±0.4 change in HAQ-DI, ±25% change in mRSS).|48 Months Post-Randomization|Per-protocol (PP). The PP population is defined as those participants who completed the assigned treatment protocol: undergoing autologous CD34-selected hematopoietic progenitor cell transplantation in the mHSCT arm, or receiving at least 9 of 12 planned doses in the cyclophosphamide arm.||Sum of subject-pair comparison scores||Full Range|Median
706344|NCT00114530|Secondary|Global Rank Composite Score (GRCS) (Month 48, ITT)|The GRCS is an analytic tool that accounts for multiple disease manifestations simultaneously. It does not measure clinical disease activity or severity but reflects how participants compared to one another based on a hierarchy of ordered outcomes: death, event-free survival (EFS), forced vital capacity (FVC), Health Assessment Questionnaire - Disability Index (HAQ-DI), and Modified Rodnan Skin Score (mRSS). Participants alive ranked higher than those who died; those who survived event-free ranked higher than EFS failures. EFS failure included death, respiratory failure (decrease from baseline of >30% in DLCO % predicted or >20% in FVC % predicted ), renal failure (chronic dialysis > 6 month or renal transplant), or cardiac failure (clinical congestive heart failure or left ventricular ejection fraction <30%). The lowest 3 GRCS components are ordinal; improvement, stability, or worsening from baseline (±10% change in FVC % predicted, ±0.4 change in HAQ-DI, ±25% change in mRSS).|48 Months Post-Randomization|Intention to treat (ITT). The ITT population includes all randomized participants.||Sum of subject-pair comparison scores||Full Range|Median
706345|NCT00114530|Secondary|Global Rank Composite Score (GRCS) (Month 54, PP)|The GRCS is an analytic tool that accounts for multiple disease manifestations simultaneously. It does not measure clinical disease activity or severity but reflects how participants compared to one another based on a hierarchy of ordered outcomes: death, event-free survival (EFS), forced vital capacity (FVC), Health Assessment Questionnaire - Disability Index (HAQ-DI), and Modified Rodnan Skin Score (mRSS). Participants alive ranked higher than those who died; those who survived event-free ranked higher than EFS failures. EFS failure included death, respiratory failure (decrease from baseline of >30% in DLCO % predicted or >20% in FVC % predicted ), renal failure (chronic dialysis > 6 month or renal transplant), or cardiac failure (clinical congestive heart failure or left ventricular ejection fraction <30%). The lowest 3 GRCS components are ordinal; improvement, stability, or worsening from baseline (±10% change in FVC % predicted, ±0.4 change in HAQ-DI, ±25% change in mRSS).|54 Months Post-Randomization|Per-protocol (PP). The PP population is defined as those participants who completed the assigned treatment protocol: undergoing autologous CD34-selected hematopoietic progenitor cell transplantation in the mHSCT arm, or receiving at least 9 of 12 planned doses in the cyclophosphamide arm.||Sum of subject-pair comparison scores||Full Range|Median
706346|NCT00114530|Primary|Global Rank Composite Score (GRCS) (Month 54, ITT)|The GRCS is an analytic tool that accounts for multiple disease manifestations simultaneously. It does not measure clinical disease activity or severity but reflects how participants compared to one another based on a hierarchy of ordered outcomes: death, event-free survival (EFS), forced vital capacity (FVC), Health Assessment Questionnaire - Disability Index (HAQ-DI), and Modified Rodnan Skin Score (mRSS). Participants alive ranked higher than those who died; those who survived event-free ranked higher than EFS failures. EFS failure included death, respiratory failure (decrease from baseline of >30% in DLCO % predicted or >20% in FVC % predicted ), renal failure (chronic dialysis > 6 month or renal transplant), or cardiac failure (clinical congestive heart failure or left ventricular ejection fraction <30%). The lowest 3 GRCS components are ordinal; improvement, stability, or worsening from baseline (±10% change in FVC % predicted, ±0.4 change in HAQ-DI, ±25% change in mRSS).|54 Months Post-Randomization|Intention to treat (ITT). The ITT population includes all randomized participants.||Sum of subject-pair comparison scores||Full Range|Median
706347|NCT00114634|Secondary|ABC Total Score|ABC total score includes all the questions from subscales, with range of 0 to 174. Higher the score , the greater the problem.|2 weeks|||units on a scale||Standard Error|Mean
706348|NCT00114634|Secondary|ABC Inappropriate Behavior Sub-scale|ABC Subscale V (Inappropriate speech) has 4 items, each can be rated from 0 to 3, with 0 equal to not at all a problems, 1 the problem is the behavior but slight in degree, 2 the problem is moderately serious, 3 the problem is severe in degree. For this subscale, score can go from 0 - 12.|2 weeks|||units on a scale||Standard Error|Mean
706349|NCT00114634|Secondary|ABC Stereotypy Sub-scale|ABC Subscale III (Stereotypy) has 7 items, each can be rated from 0 to 3, with 0 equal to not at all a problems, 1 the problem is the behavior but slight in degree, 2 the problem is moderately serious, 3 the problem is severe in degree. For this subscale, score can go from 0 - 21.|2 weeks|||units on a scale||Standard Error|Mean
706350|NCT00114634|Secondary|ABC Lethargy Sub-scale|ABC Subscale II (Lethargy) has 16 items, each can be rated from 0 to 3, with 0 equal to not at all a problems, 1 the problem is the behavior but slight in degree,2 the problem is moderately serious, 3 the problem is severe in degree. For this subscale, score can go from 0 - 48.|2 weeks|||units on a scale||Standard Error|Mean
706351|NCT00114634|Secondary|ABC Irritability Sub-scale|ABC Subscale I (Irritability) has 15 items, each can be rated from 0 to 3, with 0 equal to not at all a problem, 1 the problem is the behavior but slight in degree, 2 the problem is moderately serious, 3 the problem is severe in degree. For this subscale, score can go from 0 - 45|2 weeks|||units on a scale||Standard Error|Mean
706352|NCT00114634|Primary|Hyperactivity Sub-scale of the Aberrant Behavior Checklist-Community (ABC-C).|The Aberrant Behavior Checklist-Community (ABC-C) is a measure used to identify treatment efficacy among intellectually impaired individuals. ABC Subscale IV (Hyperactivity) has 16 items, each can be rated from 0 to 3, with 0 equal to not at all a problems, one the problem is the behavior but slight in degree, to the problem is moderately serious, 3 the problem is severe in degree. For this subscale, score can go from 0 - 48. The higher the score, the worse the hyperactivity. The comparison in this study was made between the blinded phases when patients received either egg yolk (treated, +cholesterol) or egg substitute (untreated, -cholesterol). Order was randomized.|2 weeks|||units on a scale||Standard Error|Mean
706382|NCT00114972|Secondary|Quality of Life at 1 Month Post-procedure and at 6 Months, 1, 3 and 5 Years Post-allocation||1 month after procedure and 6 months, 1, 3 and 5 years post allocation||||||
706383|NCT00114972|Secondary|Freedom From MACCE and Its Components at 5 Years Post-allocation||5 years post allocation||||||
706376|NCT00114959|Secondary|Participants With Complete Hematologic Remission Suppression of the Philadelphia Chromosome|"Complete hematologic remission was further classified according to the suppression of the Philadelphia chromosome (Ph) as:
No cytogenetic response - Ph positive 100% Minimal cytogenetic response - Ph positive 35-90% Partial cytogenetic response - Ph positive 1-34% Complete cytogenetic response - Ph positive 0%"|up to month 4|No participants were analyzed since the study was intended to follow a Simon two stage design to test 18 participants in each stratum (chronic, accelerated and blast phases) for efficacy. Enrollment was insufficient.|||||
706377|NCT00114959|Primary|Number of Participants With Adverse Experiences (AEs)|"Summary of participants who had adverse events (AEs), who discontinued treatment due to the AE, who had serious adverse events (SAEs), and who had SAEs that were related to treatments.
A serious adverse event is one that at any dose of the study drug or at any time during the period of observation:
Results in death;
Is life threatening;
Requires inpatient hospitalization or prolongation of existing hospitalization;
Results in persistent or significant disability/incapacity;
Is a congenital anomaly/birth defect;
Is medically important.
The Investigator assessed each AE for potential causal relationship between the event and study drug. An investigator assessment of possibly, probably or unknown relation is considered related."|up to 3 years|All treated participants||participants|||Number
706378|NCT00114959|Primary|Proportion of Participants With Chronic Phase Chronic Myeloid Leukemia (CML) Who Achieve a Meaningful Response|"Participants who are not in complete hematologic remission (CHR) at study start must achieve at least a CHR, and participants who are in CHR at onset must demonstrate an improvement in their cytogenetics.
A Complete Hematologic Remission (CHR) involves normalization of the bone marrow (less than 5% blasts) and peripheral blood with white blood cells < 10*10^9/L, absolute neutrophil count >=1*10^9/L, platelets >=100*10^9/L and no peripheral blasts, promyelocytes or myelocytes. This is in addition to disappearance of all signs and symptoms of the disease."|up to month 4|No participants were analyzed since the study was intended to follow a Simon two stage design to test 18 participants in each stratum (chronic, accelerated and blast phases) for efficacy. Enrollment was insufficient.|||||
706379|NCT00114959|Primary|Proportion of Participants With Accelerated Phase or Blast Phase Chronic Myeloid Leukemia (CML) Who Achieve a Meaningful Response|"Participants in accelerated or blast phase who converted to at least CML-chronic phase.
CML in accelerated phase meets one or more of the following criteria: >=15% - <30% blasts in peripheral blood or bone marrow, >=30% blasts + promyelocytes in peripheral blood or bone marrow, >=20% basophils in peripheral blood; platelet count <100*10^9/L unrelated to therapy or clonal evolution. CML in blast phase have >=30% blasts in the bone marrow or presence of extramedullary disease.
Meaningful responses include (in descending order of health)
Complete Hematologic Remission (CHR)
Partial Hematologic Remission (PHR)
Hematologic Improvement (HI)
Partial Response (PR)
Return to Chronic Phase (RCP). A return to chronic phase involves the disappearance of blastic phase features and a return to chronic phase CML picture, i.e., peripheral blasts <15%, peripheral blasts and promyelocytes <30%, peripheral basophils <20%, and platelets >100*10^9/L."|up to month 4|No participants were analyzed since the study was intended to follow a Simon two stage design to test 18 participants in each stratum (chronic, accelerated and blast phases) for efficacy. Enrollment was insufficient.|||||
706387|NCT00114972|Secondary|Individual Components of MACCE at 1 Year Post-allocation.|Number of participants with individual components of MACCE at 1 year post-allocation. The individual components of MACCE are: all cause death, stroke, documented myocardial infarction, repeat revascularization.|1 year post allocation|ITT analysis||participants|||Number
706388|NCT00114972|Secondary|Individual Components of MACCE at 6 Months Post-allocation.|Number of participants with individual components of MACCE at 6 months post-allocation. The individual components of MACCE are: all cause death, stroke, documented myocardial infarction, repeat revascularization.|6 months post allocation|ITT analysis||Participants|||Number
706389|NCT00114972|Secondary|Individual Components of MACCE at 1 Month Post-procedure.|Number of participants with individual components of MACCE at 1 month post-procedure. The individual components of MACCE are: all cause death, stroke, documented myocardial infarction, repeat revascularization.|1 month after procedure|ITT analysis||participants|||Number
706390|NCT00114972|Secondary|Overall MACCE at 1 Month Post-procedure and at 6 Months, 3 Years, and 5 Years Post-allocation.|Number of participants with Overall MACCE at 1 month post-procedure and at 6 months, 3 years, and 5 years post-allocation.|1 month after procedure and 6 months, 3 years, and 5 years post allocation|||participants|||Number
706391|NCT00114972|Primary|12-month Composite Safety Endpoint.|Number of participants at 12-month composite safety endpoint. Composite safety endpoint combines: all cause death, cerebrovascular event (stroke), and documented myocardial infarction.|12 months after enrollment|||participants|||Number
706392|NCT00114972|Primary|Primary Clinical Endpoint of 12-Month Binary MACCE.|Number of participants at primary clinical endpoint of 12-Month binary MACCE. MACCE is defined as: all cause death, cerebrovascular event (stroke), cocumented myocardial infarction, repeat revascularization (PCI and/or CABG).|12 months post enrollment|ITT analysis. Number of participants analyzed equals number of subjects who completed Overall Study, as listed in Participant Flow.||participants|||Number
706393|NCT00115063|Secondary|Change in Duke Activity Status Index (DASI) Questionnaire Score|The DASI was used to access changes in fuctional capacity during the study. The highest score possible is 58.2 and the lowest is 0. The score for each individual question varied depending on the intensity of the activity being evaluated. The higher the score, the more physically active a person is to this set of activities of daily living questions.|Baseline, 2 years|This analysis was done on the completers, those that completed the 2 year study visit.||units on a scale||Standard Error|Mean
706394|NCT00115063|Secondary|Change in Fasting Plasma Glucose (FPG) in Milligrams Per Deciliter (mg/dL)||Baseline, 2 years|This analysis was done on the completers, those that completed the 2 year study visit.||mg/dL||Standard Error|Mean
706395|NCT00115063|Secondary|Percent Change in Blood Tests- Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), Triglycerides and Uric Acid||Baseline, 2 years|This analysis was done on the completers, those that completed the 2 year study visit.||Percent change||Standard Error|Mean
706396|NCT00115063|Secondary|Change in Blood Pressure||Baseline, 2 years|This analysis was done on the completers, those that completed the 2 year study visit.||millimeter of mercury (mm Hg)||Standard Error|Mean
706397|NCT00115063|Secondary|Change in Weight From Baseline in Kilograms (kg)||Baseline, 2 years|This analysis was done on the completers, those that completed the 2 year study visit.||kg||Standard Error|Mean
706398|NCT00115063|Primary|Percent Change From Baseline Weight||Baseline, 2 years|This analysis was done on the completers, those that completed the 2 year study visit.||Percent change||Standard Error|Mean
706399|NCT00115297|Secondary|The Number of Participants Requiring Rescue Beta Agonist Use||Measured during the daytime|||participants|||Number
706400|NCT00115297|Secondary|Wheezing at Day 7||Study day 7|||participants|||Number
706401|NCT00115297|Primary|Number of Wheezing-free Days of Infant (Observed by Primary Caregiver)||First 56 days of study|||Days||Inter-Quartile Range|Median
706402|NCT00115349|Secondary|Adverse Events||continous||||||
706403|NCT00115349|Secondary|Initiation of or Increase in Cardiac Medications||continuous||||||
706404|NCT00115349|Secondary|Change in Holter Monitor Scores From Baseline to One Year.||one year||||||
706405|NCT00115349|Secondary|Change in ECHO LV Volume, Ejection Fraction, Shortening Fraction, and VCFc/Wall Stress Z-score From Baseline to One Year.||one year||||||
706406|NCT00115349|Secondary|Change in Left Ventricular (LV) Volume From Screening to One Year.||one year||||||
706407|NCT00115349|Secondary|Evaluate Whether L1/DFO Combination Therapy is Superior to DFO Monotherapy in Lowering Myocardial Iron Burden Estimated by Myocardial T2*.||one year||||||
706408|NCT00115349|Primary|Change in Left Ventricular Ejection Fraction (LVEF).|The primary outcome variable is change in left ventricular ejection fraction (blood ejected from the heart into the body) as measured by MRI from baseline to one year. The unit of primary outcome (left ventricular ejection fraction) is the percent of the blood in left ventricle.|Baseline to one year|||Percent of the blood in left ventricle||Standard Error|Least Squares Mean
706409|NCT00115739|Secondary|6 Month Survival Rate|The percentage of patients still alive at 6 months was estimated.|6 months|Eight patients completed 8 weeks of imatinib and were considered evaluable for response.||percentage of patients||95% Confidence Interval|Number
706410|NCT00115739|Secondary|6 Month Progression Free Survival Rate|The percentage of patients with 6 months progression-free survival was estimated. Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, the appearance of new lesions, or the significant clinical deterioration related to progression of patient's disease.|6 months|Eight patients completed 8 weeks of imatinib and were considered evaluable for response.||percentage of patients||95% Confidence Interval|Number
706411|NCT00115739|Secondary|Rate of Grade 3, Grade 4 and Grade 5 Toxicities Experienced by Patients With Anaplastic Thyroid Cancer Who Are Treated With Gleevec|Number of grade 3, grade 4 and grade 5 toxicities experienced by patients with anaplastic thyroid cancer who are treated with Gleevec.|Up to 30 days post treatment|Patients receiving at least one dose of imatinib were included in toxicity analysis.||events|||Number
706412|NCT00115739|Primary|Overall Response (Complete and Partial Response) Rate at 8 Weeks|The number of patients with Complete Response (CR), Partial Response (PR) and Stable Disease (SD) were determined at 8 weeks.|8 weeks|Eight patients completed 8 weeks of imatinib and were considered evaluable for response.||participants|||Number
706413|NCT00115765|Secondary|Time to Treatment Failure (Irinotecan)|Kaplan-Meier estimate of the median time from randomization to the date the decision was made to discontinue treatment for a reason other than a complete response to treatment within the irinotecan stratum|Overall Study|Intention-to-Treat||Month||95% Confidence Interval|Median
706414|NCT00115765|Secondary|Time to Progression (Irinotecan)|Kaplan-Meier estimate of the median time from randomization to disease progression or death due to disease progression within the irinotecan stratum|Overall Study|Intention-to-Treat||Month||95% Confidence Interval|Median
706415|NCT00115765|Secondary|Objective Tumor Response Rate (Irinotecan)|Best overall response of complete or partial response within irinotecan stratum|Overall Study|Intention-to-Treat||Participant|||Number
706416|NCT00115765|Post-Hoc|Objective Tumor Response Rate (Mutant KRAS)|Best overall response of complete or partial response in participants treated with irinotecan and having a mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS)|Overall Study|Subset of the KRAS Efficacy Analysis Set, composed of participants from the intention-to-treat set who received at least 1 dose of first-line treatment and for whom KRAS mutation status was assessed as mutant, who were treated with irinotecan||Participant|||Number
706417|NCT00115765|Post-Hoc|Objective Tumor Response Rate (Wild-type KRAS)|Best overall response of complete or partial response in participants treated with irinotecan and having a wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS)|Overall Study|Subset of the KRAS Efficacy Analysis Set, composed of participants from the intention-to-treat set who received at least 1 dose of first-line treatment and for whom KRAS mutation status was assessed as wild-type, who were treated with irinotecan||Participant|||Number
706418|NCT00115765|Post-Hoc|Overall Survival (Mutant KRAS)|Kaplan-Meier estimate of the median time from randomization to death from any cause in groups treated with Oxaliplatin and having a mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS). Since the measure of dispersion could not be estimated for at least one treatment arm, participant incidence is provided in lieu of the median.|Overall Study|Subset of the KRAS Efficacy Analysis Set, composed of participants from the intention-to-treat set who received at least 1 dose of first-line treatment and for whom KRAS mutation status was assessed as mutant, who were treated with oxaliplatin||Participant|||Number
706419|NCT00115765|Post-Hoc|Overall Survival (Wild-type KRAS)|Kaplan-Meier estimate of the median time from randomization to death from any cause in groups treated with Oxaliplatin and having a wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS). Since the measure of dispersion could not be estimated for at least one treatment arm, participant incidence is provided in lieu of the median|Overall Study|Subset of the KRAS Efficacy Analysis Set, composed of participants from the intention-to-treat set who received at least 1 dose of first-line treatment and for whom KRAS mutation status was assessed as wild-type, who were treated with oxaliplatin||Participant|||Number
706420|NCT00115765|Post-Hoc|Progression-free Survival (Mutant KRAS)|Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression in groups treated with oxaliplatin and having a mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS)|Overall Study|Subset of the KRAS Efficacy Analysis Set, composed of participants from the intention-to-treat set who received at least 1 dose of first-line treatment and for whom KRAS mutation status was assessed as mutant, who were treated with oxaliplatin||Month||95% Confidence Interval|Median
706421|NCT00115765|Post-Hoc|Progression-free Survival (Wild-type KRAS)|Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression in groups treated with oxaliplatin and having a wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS)|Overall Study|Subset of the KRAS Efficacy Analysis Set, composed of participants from the intention-to-treat set who received at least 1 dose of first-line treatment and for whom KRAS mutation status was assessed as wild-type, who were treated with oxaliplatin||Month||95% Confidence Interval|Median
706422|NCT00115765|Secondary|Progression-free Survival (Irinotecan)|Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression|Overall Study|Intention-to-Treat||Month||95% Confidence Interval|Median
706423|NCT00115765|Secondary|Overall Survival (Irinotecan)|Incidence of mortality from any cause in groups treated with Irinotecan. Incidence is provided in lieu of the median time to death since the median or its measure of dispersion was not estimable for at least one treatment arm.|Overall study|Intention-to-Treat||Participant|||Number
706424|NCT00115765|Primary|Objective Tumor Response Through Week 12 (Irinotecan)|Objective tumor response (complete or partial) rate through week 12 based on central review in the Irinotecan stratum|Overall Study|Intention-to-Treat||Participant|||Number
706425|NCT00115765|Secondary|Time to Treatment Failure (Oxaliplatin)|Kaplan-Meier estimate of the median time from randomization to the date the decision was made to discontinue treatment for a reason other than a complete response to treatment within the oxaliplatin stratum.|Overall study|Intention-to-Treat||Month||95% Confidence Interval|Median
706426|NCT00115765|Secondary|Time to Progression (Oxaliplatin)|Kaplan-Meier estimate of the median time from randomization to disease progression or death due to disease progression within the oxaliplatin stratum|Overall Study|Intention-to-Treat||Month||95% Confidence Interval|Median
706427|NCT00115765|Secondary|Objective Tumor Response Rate (Oxaliplatin)|Best overall response of complete or partial response within oxaliplatin stratum|Overall study|Intention-to-Treat||Participant|||Number
706428|NCT00115765|Secondary|Overall Survival (Oxaliplatin)|Kaplan-Meier estimate of the median time from randomization to death from any cause in groups treated with Oxaliplatin|Overall study|Intention-to-Treat||Month||95% Confidence Interval|Median
706429|NCT00115765|Primary|Progression-Free Survival (Oxaliplatin)|Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression|Overall study|Intention-to-Treat||Month||95% Confidence Interval|Median
706430|NCT00115804|Secondary|Fibromyalgia Impact Questionnaire Modified for Children|A 19 item self-report instrument that measures overall impact of fibromyalgia including assessments of function, pain, fatigue, sleep quality, stiffness, anxiety and depression. Score range from 0 (no impact) to 100 (severe impact).|Over the past week.|||units on a scale||Standard Deviation|Mean
706431|NCT00115804|Secondary|Multidimensional Anxiety Scale for Children|A 39-item self-report inventory that assesses four areas of anxiety symptoms (emotional, cognitive, physical, and behavioral). Score ranges from 0 (no anxiety symptoms) to 117 (severe anxiety symptoms).|Over the past week.|||units on a scale||Standard Deviation|Mean
706433|NCT00115804|Secondary|The Functional Disability Inventory-parent Version|Consists of the same 15 items as the child version but allows the parent to provide their perception of the child's difficulty in performing daily physical, social, and recreational activities. The score ranges from 0 (no disability) to 60 (severe disability).|"Over the last few days."|||units on a scale||Standard Deviation|Mean
706434|NCT00115804|Secondary|The Functional Disability Inventory-child Version|A self-report inventory that assesses patients' ability to perform a variety of daily physical, social, and recreational activities. The scale ranges from 0 (no disability) to 60 (severe disability).|"Over the last few days."|||units on a scale||Standard Deviation|Mean
706435|NCT00115804|Secondary|The Patient Global Impression of Improvement|Measures the patient's impression of improvement since baseline on a scale of 1 (very much better) to 7 (very much worse).|since baseline, at the time of the assessment|||units on a scale||Standard Deviation|Mean
706436|NCT00115804|Secondary|The Clinical Global Impression of Severity|Measures severity of illness at the time of the assessment on a scale of 1 (normal, not at all ill) to 7 (among the most extremely ill).|at the time of the assessment|||units on a scale||Standard Deviation|Mean
706437|NCT00115804|Primary|Average Pain Severity Score|"The primary outcome measure was average pain severity on the Pediatric Pain Questionnaire’s 100-mm visual analog scale.
(0=no pain and 100 = severe pain )"|Daily on average in the past week.|6 participants out of 10 screened met entry criteria. Two were terminated due to serious adverse events (SAEs).||mm||Standard Deviation|Mean
706438|NCT00115869|Primary|Whether or Not Smoking Daily at 2 Years After High School|"Response (from the 2-years-after-high school questionnaire) Daily: 1 to 10 cigarettes a day, Daily: 11 to 20 cigarettes a day, Daily: more than a pack a day to the Item How often do you currently smoke cigarettes?"|2 years after high school|||participants|||Number
706439|NCT00115869|Primary|Number of Participants Smoking Daily at 12th Grade|"Response 1 to 3 cigarettes per day, 4 to 10 cigarettes per day, 11 to 20 cigarettes per day, or More than 20 cigarettes per day to the Item How often do you currently smoke cigarettes?"|12th grade|||participants|||Number
706440|NCT00115934|Secondary|Complications: Total Number Experienced From Stage II Discharge to 14 Months of Age|Complications, reported as 'Other Adverse Events' in the safety section, are those adverse events that were not considered serious. Many normal peri-operative occurrences meet the standard criteria of an adverse event; therefore, for this trial a serious adverse event was (a) death, (b) acute shunt failure requiring intervention, (c) cardiac arrest requiring CPR and medications, (d) cardiopulmonary insufficiency requiring ECMO, (e) cardiovascular re-operation (unplanned), (f) necrotizing enterocolitis requiring laparotomy, and (g) any event considered by the study investigator as serious.|From Stage II Discharge to 14 Months of Age, an average of 8.9 months|These numbers reflect the number of patients who were discharged from the hospital after the Stage 2 procedure and were transplant-free.||complications|||Number
706441|NCT00115934|Secondary|Complications: Total Number Experienced From Norwood Discharge to Stage II Discharge|Complications, reported as 'Other Adverse Events' in the safety section, are those adverse events that were not considered serious. Many normal peri-operative occurrences meet the standard criteria of an adverse event; therefore, for this trial a serious adverse event was (a) death, (b) acute shunt failure requiring intervention, (c) cardiac arrest requiring CPR and medications, (d) cardiopulmonary insufficiency requiring ECMO, (e) cardiovascular re-operation (unplanned), (f) necrotizing enterocolitis requiring laparotomy, and (g) any event considered by the study investigator as serious.|From Norwood Discharge to Stage II discharge, an average of 4.2 months|These numbers reflect those patients who were discharged from the hospital after the Norwood procedure and were transplant free.||complications|||Number
706442|NCT00115934|Secondary|Complications: Total Number Experienced During Norwood Hospitalization|Complications, reported as 'Other Adverse Events' in the safety section, are those adverse events that were not considered serious. Many normal peri-operative occurrences meet the standard criteria of an adverse event; therefore, for this trial a serious adverse event was (a) death, (b) acute shunt failure requiring intervention, (c) cardiac arrest requiring CPR and medications, (d) cardiopulmonary insufficiency requiring ECMO, (e) cardiovascular re-operation (unplanned), (f) necrotizing enterocolitis requiring laparotomy, and (g) any event considered by the study investigator as serious.|Norwood Hospitalization, an average of 36 days|||complications|||Number
706443|NCT00115934|Secondary|Unintended Cardiovascular Interventional Procedures|Unintended cardiovascular procedures included balloon dilation of the shunt or branch pulmonary arteries, stent placement in the shunt or branch pulmonary arteries, shunt revision, crossover between MBTS and RVPAS shunt, balloon dilation, stent placement or surgical revisions of the neo-aorta, and pulmonary artery reconstructions, other than those undertaken as a standard component of the stage II procedure. The number of cardiovascular procedures was analyzed; trial participants may have had more than one unintended cardiovascular. procedure.|From Randomization to 12 months|||procedures|||Number
706444|NCT00115934|Secondary|Angiographic Findings: Right Pulmonary Artery Size|Diameter of distal right pulmonary artery. Angiograms were performed at the time points relative to the second palliative surgery (pre-Stage II).|Measured pre-stage II surgery, on average 26 days prior to stage II palliation|These patients had pre-stage II palliation visits with acceptable cardiac catheterizations.||mm||Standard Deviation|Mean
706445|NCT00115934|Secondary|Angiographic Findings: Left Pulmonary Artery Size|Diameter of distal left pulmonary artery. Angiograms were performed at the time points relative to the second palliative surgery (pre-Stage II).|Measured pre-stage II surgery, on average 26 days prior to stage II palliation|These patients had pre-stage II palliation visits with acceptable cardiac catheterizations.||mm||Standard Deviation|Mean
706446|NCT00115934|Secondary|Echocardiographic Measures of Heart Size and Function: RV Ejection Fraction|Right ventricular ejection fraction: 100 x (RV end-diastolic volume - RV end-systolic volume)/RV end-diastolic volume. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.|Measured at 14 months of age|184 and 179 patients remained in the MBTS and RVPAS groups at the 14-months of age echo. Of these, some patients did not have acceptable echos or not all measures were able to be obtained to calculate the volumes.||Percentage of RV end-diastolic volume||Standard Deviation|Mean
706459|NCT00116168|Secondary|Total Body Clearance (CL)|CL of MEDI-528|Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84|All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Two subjects in the 0.3 mg/kg group had no blood samples for pharmacokinetic analysis.||Liter per day||Standard Deviation|Mean
706447|NCT00115934|Secondary|Echocardiographic Measures of Heart Size and Function: RV Ejection Fraction|Right ventricular ejection fraction: 100 x (RV end-diastolic volume - RV end-systolic volume)/RV end-diastolic volume. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.|Measured pre-stage II surgery, an average of 15 days pre-stage II surgery|181 and 214 patients remained in the MBTS and RVPAS groups at the time of the pre-Stage II echo. Of these, some patients did not have acceptable echos or not all measures were able to be obtained to calculate the volumes.||Percentage of RV end-diastolic volume||Standard Deviation|Mean
706448|NCT00115934|Secondary|Echocardiographic Measures of Heart Size and Function: RV Ejection Fraction|Right ventricular ejection fraction: 100 x (RV end-diastolic volume - RV end-systolic volume)/RV end-diastolic volume. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.|Measured post-Norwood, an average of 17 days post-Norwood|241 and 239 patients remained in the MBTS and RVPAS groups at the time of the post-Norwood echo. Of these, some patients did not have acceptable echos or not all measures were able to be obtained to calculate the volumes used to calculate the ejection fraction.||Percentage of RV end-diastolic volume||Standard Deviation|Mean
706449|NCT00115934|Secondary|Echocardiographic Measures of Heart Size and Function: RV End-systolic Volume Indexed to BSA|Right ventricular end-systolic volume indexed to BSA^1.3. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.|Measured at 14 months of age|184 and 179 patients remained in the MBTS and RVPAS groups at the 14-months of age echo. Of these, some patients did not have acceptable echos or not all measures were able to be obtained to calculate the volumes.||ml/m^2.6||Inter-Quartile Range|Median
706450|NCT00115934|Secondary|Echocardiographic Measures of Heart Size and Function: RV End-systolic Volume Indexed to BSA|Right ventricular end-systolic volume indexed to BSA^1.3. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.|Measured pre-stage II surgery, an average of 15 days pre-stage II surgery|181 and 214 patients remained in the MBTS and RVPAS groups at the time of the pre-Stage II echo. Of these, some patients did not have acceptable echos or not all measures were able to be obtained to calculate the volumes.||ml/m^2.6||Inter-Quartile Range|Median
706451|NCT00115934|Secondary|Echocardiographic Measures of Heart Size and Function: RV End-systolic Volume Indexed to BSA|Right ventricular end-systolic volume indexed to BSA. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.|Measured post-Norwood, an average of 17 days post-Norwood|241 and 239 patients remained in the MBTS and RVPAS groups at the time of the post-Norwood echo. Of these, some patients did not have acceptable echos or not all measures were able to be obtained to calculate the volumes.||ml/m^2.6||Inter-Quartile Range|Median
706452|NCT00115934|Secondary|Echocardiographic Measures of Heart Size and Function: RV End-diastolic Volume Indexed to BSA|Right ventricular end-diastolic volume indexed to BSA^1.3. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.|Measured at 14 months of age|184 and 179 patients remained in the MBTS and RVPAS groups at the 14-months of age echo. Of these, some patients did not have acceptable echos or not all measures were able to be obtained to calculate the volumes.||ml/m^2.6||Inter-Quartile Range|Median
706453|NCT00115934|Secondary|Echocardiographic Measures of Heart Size and Function: RV End-diastolic Volume Indexed to BSA|Right ventricular end-diastolic volume indexed to BSA^1.3. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.|Measured pre-stage II surgery, an average of 15 days pre-stage II surgery|181 and 214 patients remained in the MBTS and RVPAS groups at the time of the pre-Stage II echo. Of these, some patients did not have acceptable echos or not all measures were able to be obtained to calculate the volumes.||ml/m^2.6||Inter-Quartile Range|Median
706454|NCT00115934|Secondary|Echocardiographic Measures of Heart Size and Function: Right Ventricle (RV) End-diastolic Volume Indexed to Body Surface Area (BSA)|Right ventricular end-diastolic volume indexed to BSA^1.3. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.|Measured post-Norwood, an average of 17 days post-Norwood|241 and 239 patients remained in the MBTS and RVPAS groups at the time of the post-Norwood echo. Of these, some patients did not have acceptable echos or measures were not able to be obtained to calculate the volumes.||ml/m^2.6||Inter-Quartile Range|Median
706455|NCT00115934|Secondary|Proportion of Deaths or Heart Transplants Over Time From Randomization to the End of the Trial|This secondary outcome was the proportion of deaths or cardiac transplantation over time from randomization to the end of the trial.|From Randomization to the End of the Trial, an average of 32 months|||Participants|||Number
706456|NCT00115934|Primary|Proportion of Patients Who Died or Received a Heart Transplant|The primary outcome was the proportion of patients who died or had cardiac transplantation 12 months after randomization.|Measured at 12 months|555 subjects were enrolled in the study; 5 of these subjects were excluded from analyses because a Norwood procedure was not performed; 1 subject was excluded because the subject withdrew before the 12-month follow-up, 12-month status was unknown. The data were analyzed on an intention to treat basis, subjects were analyzed as randomized.||Participants|||Number
706457|NCT00116168|Secondary|Apparent Extravascular Terminal Phase Volume of Distribution (Vz/F)|Vz/F of MEDI-528|Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84|All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Two subjects in the 0.3 mg/kg group had no blood samples for pharmacokinetic analysis.||Liters||Standard Deviation|Mean
706458|NCT00116168|Secondary|Half-life (T1/2)|T1/2 of MEDI-528|Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84|All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Two subjects in the 0.3 mg/kg group had no blood samples for pharmacokinetic analysis.||Days||Standard Deviation|Mean
706508|NCT00108628|Secondary|Clinician-Administered PTSD Scale (CAPS)|Seventeen questions assess the frequency and intensity of PTSD symptoms. Scores range from zero to 136, with a higher score indicating more severe symptoms.|Baseline and 1 month post-treatment|||units on a scale||Standard Deviation|Mean
706460|NCT00116168|Secondary|Percent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)]|AUC(ext) of MEDI-528|Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84|All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Two subjects in the 0.3 mg/kg group had no blood samples for pharmacokinetic analysis.||Percent||Standard Deviation|Mean
706461|NCT00116168|Secondary|Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)] of MEDI-528|AUC(0-infinity) of MEDI-528|Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84|All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Two subjects in the 0.3 mg/kg group had no blood samples for pharmacokinetic analysis.||Microgram times day per milliliter||Standard Deviation|Mean
706462|NCT00116168|Secondary|Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)]|AUC(0-t) of MEDI-528|Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84|All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Two subjects in the 0.3 mg/kg group had no blood samples for pharmacokinetic analysis.||Micrograms times day per milliliter||Standard Deviation|Mean
706463|NCT00116168|Secondary|Observed Maximum Serum Concentration (Cmax)|Cmax of MEDI-528|Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84|All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Two subjects in the 0.3 mg/kg group had no blood samples for pharmacokinetic analysis.||Micrograms per milliliter||Standard Deviation|Mean
706464|NCT00116168|Secondary|Time to Observed Maximum Serum Concentration (Tmax)|Tmax of MEDI-528|Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84|All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Two subjects in the 0.3 mg/kg group had no blood samples for pharmacokinetic analysis.||Days||Standard Deviation|Mean
706465|NCT00116168|Secondary|Incidence of Anti-drug Antibodies (ADA) to MEDI-528|Number of participants with ADA to MEDI-528|Days 0, 14, 28, 42, and 84|All subjects who received MEDI-528 (no safety or ADA information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Partial ADA information was available in the 0.3 mg/kg group (Day 0 and 14, n=5; Day 28, n=2; Day 42 and 84, n = 0)||Participants|||Number
706466|NCT00116168|Primary|Incidence of Serious Adverse Events|Number of participants experiencing serious adverse events|Days 0 - 84|All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina)||Participants|||Number
706467|NCT00116168|Primary|Incidence of Changes From Baseline in the Day 28 Magnetic Resonance Imaging (MRI) of the Brain|Number of participants with changes from baseline in the Day 28 MRI of the brain|Days 0 and 28|All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina)||Participants|||Number
706468|NCT00116168|Primary|Incidence of Clinically Significant Changes From Baseline in Neurologic Exam|Number of participants with clinically significant changes from baseline in neurologic exam|Days 0, 7, 14, 21, 28, 42, and 84|All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina)||Participants|||Number
706469|NCT00116168|Primary|Incidence of Abnormal Troponin Levels|Number of participants with troponin levels greater than upper limit of normal|Days 0, 1, 7, 14, and 28|All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina)||Participants|||Number
706470|NCT00116168|Primary|Incidence of Adverse Events|Number of participants experiencing adverse events (includes both adverse events and serious adverse events)|Days 0 - 84|All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina)||Participants|||Number
706471|NCT00116207|Secondary|Inflammation|High Sensitivity CRP (nmol/L)|24 months|||nmol/L||Standard Deviation|Mean
706472|NCT00116207|Secondary|Systemic Oxidative Stress|ng of 8-epi prostaglandin F2alpha /G creatinine assessed in 24 hour urine collection|24 months|||ng/G creatinine||Standard Deviation|Mean
706473|NCT00116207|Secondary|Global Coronary Flow Reserve as a Measure of Endothelial Function|global myocardial blood flow reserve as a measure of endothelial function. Measured by PET using [13N]ammonia at rest and during adenosine stimulated coronary vasodilation.|Baseline, 24 months|||ratio (rest:stress)||Standard Deviation|Mean
706474|NCT00116207|Primary|Global [11C]HED Retention Index (RI)|"Distal defects in [11C]meta-hydroxyephedrine ([11C]HED) retention involving at least 10 % of the left ventricle was used to define Cardiac Autonomic Neuropathy (CAN). The retention index (RI) is the unit of measure and is expressed as [11C]HEDblood min -1[ml tissue]-1
PET Data of Randomized Subjects at Baseline and 24-Months
The primary outcome was the change in the global [11C]HED RI = measure of cardiac innervation at 24 months in participants taking the active drug compared with those on placebo."|Baseline, 24 months|||Retention index||Standard Deviation|Mean
706475|NCT00116272|Secondary|Percentage of Infants With Abnormal Results on Ages and Stages Questionnaire (ASQ)|"The ASQ-3 evaluates 5 domains of development: communication, gross motor, fine motor, problem solving, and personal-social. Each domain has a set of 6 items and parents rate the most appropriate answer for the presence of each skill: Yes,” “Sometimes,” “Not Yet,” with point values of 10, 5, or 0, respectively. Each domain question set is totaled independently and compared against statistically derived cutoffs that are set at 2 standard deviations below the mean. The percentage of infants below the cut-off or close to the cutoff (borderline) is reported."|1 year after birth|Live-born infants, including singletons and 1 randomly selected twin from multiple pregnancies, where data were available.||Percentage of infants|||Number
706476|NCT00116272|Secondary|Percentage of Infants Diagnosed With Any Malignancy Through One Year of Age||From birth to 1 year|Live-born infants, including singletons and 1 randomly selected twin from multiple pregnancies, born to enrolled women exposed to etanercept at any time during pregnancy (Etanercept-Exposed).||Percentage of infants|||Number
706477|NCT00116272|Secondary|Percentage of Infants With Reported Serious or Opportunistic Infections Through One Year||From birth to 1 year|Live-born infants, including singletons and 1 randomly selected twin from multiple pregnancies, born to enrolled women exposed to etanercept at any time during pregnancy (Etanercept-Exposed).||Percentage of infants|||Number
710937|NCT00168844|Secondary|Change From Baseline in Basophils|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||percentage of white blood cell count||Standard Deviation|Mean
706478|NCT00116272|Secondary|Percentage of Infants at One Year of Age With Small for Gestational Age Head Circumference|Postnatal growth deficiency defined as ≤ 10th centile for chronological age. Age adjusted for gestational age at delivery if child was less than 12 months of age at postnatal measurement, unadjusted if ≥ 12 months of age at postnatal measurement.|1 year after birth|Live-born infants, excluding multiple births, where data were available.||percentage of infants|||Number
706479|NCT00116272|Secondary|Percentage of Infants at One Year of Age With Small for Gestational Age Length|Postnatal growth deficiency defined as ≤ 10th centile for chronological age. Age adjusted for gestational age at delivery if child was less than 12 months of age at postnatal measurement, unadjusted if ≥ 12 months of age at postnatal measurement.|1 year after birth|Live-born infants, excluding multiple births, where data were available.||percentage of infants|||Number
706480|NCT00116272|Secondary|Percentage of Infants at One Year of Age With Small for Gestational Age Weight|Postnatal growth deficiency defined as ≤ 10th centile for chronological age. Age adjusted for gestational age at delivery if child was less than 12 months of age at postnatal measurement, unadjusted if ≥ 12 months of age at postnatal measurement.|1 year after birth|Live-born infants, excluding multiple births, where data were available.||percentage of infants|||Number
706481|NCT00116272|Secondary|Postnatal Head Circumference Percentile at One Year||1 year after birth|Live-born infants, excluding multiple births, where 1-year data were available||percentile||Standard Deviation|Mean
706482|NCT00116272|Secondary|Postnatal Length Percentile at One Year||1 year after birth|Live-born infants, excluding multiple births, where 1-year data were available||percentile||Standard Deviation|Mean
706483|NCT00116272|Secondary|Postnatal Weight Percentile at One Year||1 year after birth|Live-born infants, excluding multiple births, where 1-year data were available||percentile||Standard Deviation|Mean
706484|NCT00116272|Secondary|Percentage of Infants With Small for Gestational Age Birth Head Circumference|Small for gestational age is defined as ≤ 10th percentile for sex and gestational age using National Center for Health Statistics (NCHS) / Center for Disease Control (CDC) growth curves.|At birth|Live-born infants, excluding multiple births, where data were available.||percentage of infants|||Number
706485|NCT00116272|Secondary|Percentage of Infants With Small for Gestational Age Birth Length|Small for gestational age is defined as ≤ 10th percentile for sex and gestational age using National Center for Health Statistics (NCHS) / Center for Disease Control (CDC) growth curves.|At birth|Live-born infants, excluding multiple births, where data were available.||percentage of infants|||Number
706486|NCT00116272|Secondary|Percentage of Infants With Small for Gestational Age Birth Weight|Small for gestational age is defined as ≤ 10th percentile for sex and gestational age using National Center for Health Statistics (NCHS) / Center for Disease Control (CDC) growth curves.|At birth|Live-born infants, excluding multiple births, where data were available.||percentage of infants|||Number
706487|NCT00116272|Secondary|Birth Head Circumference Among Full Term Infants||At birth|Live birth full-term infants, excluding multiple births, where data were available||cm||Standard Deviation|Mean
706488|NCT00116272|Secondary|Birth Length Among Full Term Infants||At birth|Live birth full-term infants, excluding multiple births, where data were available||cm||Standard Deviation|Mean
706489|NCT00116272|Secondary|Birth Weight Among Full Term Infants||At birth|Live birth full-term infants, excluding multiple births, where data were available||g||Standard Deviation|Mean
706490|NCT00116272|Secondary|Gestational Age at Delivery (GAD) of Live Births||At birth|Live births in women enrolled and exposed to etanercept prior to 37 weeks’ gestation (Etanercept-Exposed) or enrolled prior to 37 weeks gestation (Diseased Controls), excluding multiple births.||weeks||Standard Deviation|Mean
706491|NCT00116272|Secondary|Percentage of Participants With Pre-term Delivery|A pretem delivery is defined as prior to 37 weeks gestation. Computed using Kaplan-Meier estimate at 37 weeks’ gestation, accounting for left truncation due to varying time in gestation at enrollment. Multiple births are excluded.|9 months|Participants enrolled and exposed to etanercept prior to 37 weeks gestation (Etanercept-Exposed) or enrolled prior to 37 weeks gestation (Diseased Controls), and excluding multiple births.||percentage of participants||95% Confidence Interval|Number
706492|NCT00116272|Secondary|Percentage of Pregnancies Ending in Spontaneous Abortion|Computed using Kaplan-Meier estimate at 20 weeks gestation, accounting for left truncation due to varying time in gestation at enrollment. In multiple pregnancies ending in at least 1 live-born infant, the live birth outcome is included in the analysis. In multiples ending in no live birth outcomes, the spontaneous abortion is counted as 1 event.|9 months|Participants enrolled and exposed to etanercept prior to 20 weeks gestation (Etanercept-Exposed) or enrolled prior to 20 weeks gestation (Diseased Controls).||percentage of pregnancies||95% Confidence Interval|Number
706493|NCT00116272|Secondary|Percentage of Infants With a Specific Pattern of Any 3 or More Minor Birth Defects|A minor structural defect is defined as a defect which occurs in less than 4 percent of the population but which has neither cosmetic nor functional significance to the child (e.g., complete 2,3 syndactyly of the toes). A pattern is defined as at least the same 3 specific minor malformations occurring in at least two infants in the exposed group.|From birth through 1 year of age|Children born to enrolled participants who received the dysmorphological exam. Includes multiples who received the exam for consideration of pattern; co-twins with the same 3 or more minor defects could not constitute a pattern on their own. Only women exposed to etanercept in the 1st trimester are included in the Etanercept-Exposed cohort.||percentage of infants|||Number
706494|NCT00116272|Secondary|Percentage of Infants With Any 3 or More Minor Birth Defects|A minor structural defect is defined as a defect which occurs in less than 4 percent of the population but which has neither cosmetic nor functional significance to the child (e.g., complete 2,3 syndactyly of the toes). The Registry used the Metropolitan Atlanta Congenital Defects Program (MACDP) birth defect classification system, with some specified modifications that are appropriate for cohort studies as opposed to case-control studies.|From birth through 1 year of age|Children born to enrolled participants during the study who received the dysmorphological exam. Includes singletons and 1 randomly selected twin from twin pairs. Only women exposed to etanercept in the 1st trimester are included in the Etanercept-Exposed cohort.||percentage of infants|||Number
706579|NCT00109473|Secondary|IMPACT III Score|Health-related quality of life (QOL)was assessed using the IMPACT 111 questionnnaire. It is a self-administered 35 item questionnaire which typically takes 10-15 minutes to complete. Scores range from 0-350, with higher scores reflecting better perceived quality of life.|Baseline, 12 weeks, 24 weeks|||Scores on a scale||95% Confidence Interval|Mean
706495|NCT00116272|Primary|Percentage of Infants With Major Birth Defects in All Pregnancies|A major structural defect is defined as a defect which has either cosmetic or functional significance to the child (e.g., a cleft lip). The Registry used the Metropolitan Atlanta Congenital Defects Program (MACDP) birth defect classification system, with some specified modifications that are appropriate for cohort studies as opposed to case-control studies.|From birth through 1 year of age|Includes multiple pregnancies counted as 1 outcome; any 1 or more malformed infant counted as 1 major malformation in the numerator and 1 outcome in the denominator. Excludes 9 lost-to-follow-up in Etanercept-Exposed and 6 in Diseased Controls cohort. Only women exposed to etanercept in 1st trimester are included in the Etanercept-Exposed cohort.||percentage of participants|||Number
706496|NCT00116272|Primary|Percentage of Infants With Major Birth Defects in Pregnancies Ending With Live-born Infants|A major structural defect is defined as a defect which has either cosmetic or functional significance to the child (e.g., a cleft lip). The Registry used the Metropolitan Atlanta Congenital Defects Program (MACDP) birth defect classification system, with some specified modifications that are appropriate for cohort studies as opposed to case-control studies.|From birth through 1 year of age|Includes multiple pregnancies ending in at least 1 live-born infant; any 1 or more malformed live-born infants counted as 1 major malformation outcome in the numerator, and 1 pregnancy outcome in the denominator. Only women exposed to etanercept in the 1st trimester are included in the Etanercept-Exposed cohort.||percentage of participants|||Number
706502|NCT00108485|Primary|Change in Proteinuria||Baseline, 1 year|Nine participants were enrolled into this study, however baseline data is only available for 2 participants (1 from the Extended Release Niacin arm and 1 from the Placebo arm). Data was only analyzed for 2 participants.||mg/dL|||Number
706503|NCT00108524|Secondary|Change From Baseline in Blood Sugar at 48 Weeks|Measured change in Fasting glucose, mg/dL, from baseline to 48 weeks.|Baseline and 48 weeks|||mg/dL||95% Confidence Interval|Mean
706504|NCT00108524|Secondary|Change From Baseline in Risk Factors for Heart Disease (e.g., Lipid Profiles) at 48 Weeks|Measured change in low-density lipoprotein cholesterol, or LDL-C, from baseline to 48 weeks.|baseline and 48 weeks|||mg/dL||95% Confidence Interval|Mean
706505|NCT00108524|Primary|Change From Baseline in Body Weight at 48 Weeks|Body weight was measured using the same calibrated scale (Tanita Corp, Arlington Heights, Illinois) at each visit at the same time of day, with the participant wearing light clothing and no shoes.|baseline and 48 weeks|||percentage of weight loss||95% Confidence Interval|Mean
706506|NCT00108550|Secondary|Roland and Morris Disability Index Scores Adjusted for Time|"This questionnaire measures disability in everyday function due to back pain. It is a 24-item checklist asking patients to endorse whether or not back pain limits activities they normally do (eg, I stay at home most of the time because of my back). Scores range from 0 to 24, with higher scores indicating greater disability in everyday function due to back pain. The single values reported below represent adjusted means of scores over all time points."|Baseline to Week 12 with Interim Measurement at Weeks 1, 2, 3, 4, 5, 7 and 9|Randomized participants who received one dose of study drug||units on a scale||95% Confidence Interval|Mean
706507|NCT00108550|Primary|Transformed Descriptor Differential Scale-Pain Intensity Scores Adjusted for Time|"Self-report measure of current pain intensity of chronic back pain. Participants rate pain on a 20 point scale as being greater or less intense relative to 12 adjectival descriptor word anchors (eg, greater or less than faint, moderate, strong). Scores range from 0 to 20 with higher scores indicating higher pain intensity. Prior to analysis an order-preserving mean-matching variance-stabilizing transformation was applied to this measure placing it on a continuous 0-1.5 scale. The single values reported below represent adjusted means of transformed pain intensity over all time points."|Baseline to Week 12 with Interim Measurement at Weeks 1, 2, 3, 4, 5, 7 and 9|Analysis of all randomized participants receiving study drug||units on a scale||95% Confidence Interval|Mean
706509|NCT00108628|Secondary|SF-36 Mental Component|"The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Scales 5-8 primarily contribute to the mental component summary score (PCS) of the SF-36. Scores on each scale are summed and averaged (range = 0 worst-100 best)."|Baseline and 1, 3, and 6 months post-treatment|||units on a scale||Standard Deviation|Mean
706510|NCT00108628|Secondary|SF-36 Physical Component|"The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Scales 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Scores on each scale are summed and averaged (range = 0 worst-100 best)."|Baseline and 1, 3, and 6 months post-treatment|||units on a scale||Standard Deviation|Mean
706511|NCT00108628|Secondary|Beck Depression Inventory|Twenty-one items are rated on a 4-point scale. Total scores range from zero to 63, with higher scores indicating more severe depression.|Baseline and 1, 3, and 6 months post-treatment|||units on a scale||Standard Deviation|Mean
706512|NCT00108628|Secondary|PTSD Military Checklist|Seventeen items indicating the 17 DSM-IV criteria for PTSD are rated on a 5-point scale, from 1 to 5. Scores range from 17 to 85, with a higher score indicating greater symptom severity.|Baseline and 1, 3, and 6 months post-treatment|||units on a scale||Standard Deviation|Mean
706513|NCT00108628|Secondary|Nightmare Effects Survey|This self-report questionnaire assesses psychosocial impairment attributed to nightmares. Eleven self-report questions are rated on a scale of zero to four. The individual scores are summed to produce a total score ranging from 0 to 44 (reported in the Table). Higher scores reflect greater impairment.|Baseline and 1, 3, and 6 months post-treatment|||units on a scale||Standard Deviation|Mean
706514|NCT00108628|Secondary|Pittsburgh Sleep Quality Index - Addendum|The PSQI-A is a measure of PTSD-related sleep and dream disturbances. Scores can range from 0 to 21, with higher scores reflecting greater sleep problems.|Baseline and 1, 3, and 6 months post-treatment|||units on a scale||Standard Deviation|Mean
706515|NCT00108628|Primary|Pittsburgh Sleep Quality Index|Total scores range from 0 to 21, with higher values indicating poorer sleep quality. A score greater than 5 distinguishes between poor and good sleepers.|Baseline and 1, 3, and 6 months post-treatment|||units on a scale||Standard Deviation|Mean
706516|NCT00108628|Primary|Weekly Nights With a Nightmare||Baseline and 1, 3, and 6 months post-treatment|||nights/week||Standard Deviation|Mean
706517|NCT00108628|Primary|Weekly Number of Nightmares||Baseline and 1, 3, and 6 months post-treatment|||weekly nightmares||Standard Deviation|Mean
706518|NCT00108732|Secondary|The Difference Between PSA Slopes Before and After Treatment|PSA slopes were assessed by multiple PSA values obtained prior to registration and during treatment. Only patients who completed at least 3 months of treatment were included in this analysis. The PSA slopes were calculated by a piecewise linear model using the three or four PSA values obtained prior to registration and PSA measurements obtained every 4 weeks for the first six months of treatment. Natural log transformed PSA levels were used in this analysis, and the difference between PSA slopes before and after treatment was calculated.|Assessed monthly during the first 24 weeks and then every 3 months for a maximum total of 24 months|Only 31 patients who completed at least 3 months of treatment were included in this analysis.||log PSA/month||Full Range|Median
706519|NCT00108732|Secondary|Difference Between Day 4 PSA Level and Day 15 PSA Level|PSA level was assessed on Day 4 and Day 15 of cycle 1, and a comparison between the two measurements was done.|Assessed at day 4 and day 15 of cycle 1|Only 22 patients with both day 4 and day 15 PSA levels available were included in this analysis.||ng/mL||Full Range|Median
706520|NCT00108732|Secondary|Proportion of Patients With PSA Response|"PSA response is defined as complete biochemical response or partial response.
Complete Response:
A PSA < 0.2 ng/mL confirmed by a repeat PSA one month later is considered a complete biochemical response for patients with prior radical prostatectomy. A PSA < 1 ng/mL on three separate occasions taken at least one month apart is considered a complete biochemical response in patients with radiation therapy only.
Partial Response:
A reduction in PSA by > 50% from baseline, confirmed by repeat PSA 1 month later."|Assessed monthly during the first 24 weeks and then every 3 months for a maximum total of 24 months|Only eligible and treated patients in step I are included in this analysis.||Proportion of patients||90% Confidence Interval|Number
706521|NCT00108732|Primary|Proportion of Patients Free of PSA Progression at 6 Months (Prior to the Start of Androgen Ablation)|"For patients who achieved a > 50% decline in PSA, an increase in PSA value by 50% over the nadir, confirmed by a second PSA two weeks later is considered progressive disease. The PSA rise must be at least 5 ng/mL or back to pretreatment baseline, whichever is greater.
Changes in PSA below 5 ng/mL will not be considered assessable for progression.
For patients whose PSA has not decreased by 50%, an increase in PSA value > 50% of baseline (on trial) or nadir PSA, whichever is lower, confirmed by a repeat PSA two weeks later is considered progressive disease. The PSA must have risen by at least 5 ng/mL."|Assessed at 6 months|Only eligible and treated patients in step I are included in this analysis.||Proportion of patients||90% Confidence Interval|Number
706522|NCT00108862|Secondary|Percent of Participants Whose HIV Viral Load Was Less Than 400 Copies/mL at Week 48.|All eligible participants were included in the analysis. Participants who were lost-to-follow-up (LFU) prior to week 48 or who were alive with a HIV viral load at least 400 copies/mL were grouped separately those those who died or who had HIV viral loads below 400 copies/mL. Participants missing HIV viral loads at week 48 were coded as LFU in this analysis. Percents were calculated with associated standard errors.|Through week 48|Numbers presented use the intent-to-treat approach (i.e., ignoring changes from randomized treatment strategy).||percent of participants||95% Confidence Interval|Number
706523|NCT00108862|Secondary|Percent of Participants With HIV IRIS.|All eligible participants were included in this analysis. The percent of participants with HIV-associated immune reconstitution inflammatory syndrome (IRIS) was calculated with an associated standard error.|Through week 48|Numbers presented use the intent-to-treat approach (i.e., ignoring changes from randomized treatment strategy).||percent of participants||95% Confidence Interval|Number
706524|NCT00108862|Secondary|Percent of Participants With MTB IRIS.|All eligible participants were included in this analysis. The percent of participants with Mycobacteria tuberculosis (MTB)-associated immune reconstitution inflammatory syndrome (IRIS) was calculated with an associated standard error.|Through week 48|Numbers presented use the intent-to-treat approach (i.e., ignoring changes from randomized treatment strategy).||percent of participants||95% Confidence Interval|Number
706525|NCT00108862|Secondary|Percent of Participants Whose CD4 Increased by at Least 100 Cells/mm^3 Between Baseline and Week 48.|All eligible participants were included in the analysis. Participants who were lost-to-follow-up (LFU) prior to week 48 or who were alive with a CD4 cell count increase of less than 100 cells/mm^3 were grouped separately those who died or whose CD4 cell count increased by at least 100 cells/mm^3. Participants missing CD4 cell counts at week 48 were coded as LFU in this analysis. The percents were calculated with associated standard errors.|Through week 48|Numbers presented use the intent-to-treat approach (i.e., ignoring changes from randomized treatment strategy).||percent of participants||95% Confidence Interval|Number
706526|NCT00108862|Secondary|Percent of Participants With Confirmed or Probable Tuberculosis (TB) Whose TB Resolved, or Who Required TB Treatment Through the End of Follow-up, or Died, or Were Lost to Follow-up.|TB treatment outcome was assessed in the 800 eligible participants who had confirmed or probable TB at study entry. The sites determined if the TB was resolved. If TB was not resolved, TB treatment outcome status was determined based on whether TB treatment was ongoing at the last study visit; if the participant died while TB treatment was ongoing; or if the participant was lost to follow-up, withdrew consent, or other reason for lacking TB resolution status. Percents were calculated with associated standard errors.|Through week 48|Participants with confirmed or probable TB at study entry were included in this analysis. Numbers presented use the intent-to-treat approach (i.e., ignoring changes from randomized treatment strategy).||percent of participants||95% Confidence Interval|Number
706527|NCT00108862|Secondary|Percent of Participants Who Interrupted or Discontinued at Least One Tuberculosis (TB) Medication Due to Toxicity.|All eligible participants were included in this analysis. The percent of participants who interrupted at least one TB medication for more than one day due to toxicity or discontinued at least one TB medication due to toxicity was calculated with an associated standard error.|Through week 48|||percent of participants||95% Confidence Interval|Number
706528|NCT00108862|Secondary|Percent of Participants With Culture-confirmed Tuberculosis (TB) Who Survived Without AIDS Progression.|This analysis was based on 374 participants with culture-confirmed TB at entry. The percent with culture-confirmed TB surviving without a new AIDS-defining illness was calculated using a Kaplan-Meier estimator with an associated standard error.|Through week 48|Numbers presented use the intent-to-treat approach (i.e., ignoring changes from randomized treatment strategy).||percent of participants||95% Confidence Interval|Number
706529|NCT00108862|Secondary|Time to First New AIDS-defining Illness or Death.|All eligible participants were included in this analysis. Weeks from randomization to first new AIDS-defining illness or death was analyzed using a stratified Cox proportional hazards regression model. The stratification was by screening CD4 cell count: <50 cells/mm3 versus =>50 cells/mm3.|Through week 48|Numbers presented use the intent-to-treat approach (i.e., ignoring changes from randomized treatment strategy).||weeks||95% Confidence Interval|Number
706530|NCT00108862|Secondary|Percent of Participants Reporting a Grade 3 or 4 Adverse Event or Laboratory Abnormality|All eligible participants were included in this analysis. The percent of participants whose highest reported grade of adverse events and laboratory abnormalities was Grade 3 or 4 was calculated with an associated standard error, where Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening/disabling, and Grade 5=death.|Through week 48|Numbers presented use the intent-to-treat approach (i.e., ignoring changes from randomized treatment strategy).||percent of participants||95% Confidence Interval|Number
706531|NCT00108862|Other Pre-specified|Percent of Participants in the Greater Than or Equal to 50 Cells/mm^3 CD4 Stratum Who Survived Without AIDS Progression.|Participants were included as described in the Outcome Measure Description for the Primary Outcome, except that only those in the =>50 CD4 stratum were analyzed. The percent surviving without a new AIDS-defining illness was calculated using a Kaplan-Meier estimator with an associated standard error.|Through week 48|Numbers presented use the intent-to-treat approach (i.e., ignoring changes from randomized treatment strategy).||percent of participants||95% Confidence Interval|Number
706532|NCT00108862|Other Pre-specified|Percent of Participants in the Less Than 50 Cells/mm^3 CD4 Stratum Who Survived Without AIDS Progression.|Participants were included as described in the Outcome Measure Description for the Primary Outcome, except that only those in the <50 CD4 stratum were analyzed. The percent surviving without a new AIDS-defining illness was calculated using a Kaplan-Meier estimator with an associated standard error.|Through week 48|Numbers presented use the intent-to-treat approach (i.e., ignoring changes from randomized treatment strategy).||percent of participants||95% Confidence Interval|Number
706533|NCT00108862|Primary|Percent of Participants Who Survived Without AIDS Progression.|As this was a study of the strategy of providing antiretroviral therapy (ART) during the initial treatment of TB versus deferring ART until TB was treated for 8-12 weeks, all eligible participants randomized were followed for 48 weeks, whether they started ART as scheduled, whether they started ART at all, or even if the participant did not have TB and discontinued TB treatment. The percent surviving without a new AIDS-defining illness was calculated using a Kaplan-Meier estimator with an associated standard error.|Through week 48|Numbers presented use the intent-to-treat approach (i.e., ignoring changes from randomized treatment strategy).||percent of participants||95% Confidence Interval|Number
706534|NCT00108953|Secondary|Percentage of Participants for Whom Disease Control Was Achieved|Participants with disease control: those who have as best response complete response (CR), partial response (PR) or stable disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase for progressive disease) according to Response Evaluation Criteria in Solid Tumors (RECIST)|from date of randomization to end of treatment plus 30 days|The ITT population, primary population for efficacy analysis, includes all randomized patients.||Percentage of participants|||Number
706535|NCT00108953|Secondary|Time to Response (TTR)|Time from date of randomization to date of first objective response (complete response [CR] or partial response [PR]) is documented and confirmed according to RECIST criteria|from date of randomization until 3 years later at end of study|The ITT population, primary population for efficacy analysis, includes all randomized patients.||days||Full Range|Median
706536|NCT00108953|Secondary|Duration of Response|Time from date of first objective response (complete response [CR] or partial response [PR]) to date progression is first documented (as defined per independent central radiological assessment) or death, whichever occurs first|from date of randomization of the first patient until 3 years later|The ITT population, primary population for efficacy analysis, includes all randomized patients.||days||Full Range|Median
706537|NCT00108953|Secondary|Time to Symptomatic Progression (TTSP)|Time from date of randomization to date of first documented symptomatic progression defined by Functional Assessment of Cancer Therapy Hepatobiliary Symptom Index-8 (FHSI-8) assessment|from date of randomization of the first patient until 3 years later|The ITT population, primary population for efficacy analysis, includes all randomized patients.||days||95% Confidence Interval|Median
706538|NCT00108953|Secondary|Percentage of Participants in Each Category of Best Tumor Response|Percentage of participants with complete or partial response (CR or PR) confirmed according to Response Evaluation Criteria in Solid Tumors (RECIST) and achieved during treatment or 30 days after end of treatment. CR: disappearance of all clinical and radiological tumor lesions. PR: at least 30% decrease in sum of the longest diameters of tumor lesions. Stable disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase for progressive disease.|achieved during treatment or within 30 days after termination of active therapy|The ITT population, primary population for efficacy analysis, includes all randomized patients.||Percentage of participants|||Number
706539|NCT00108953|Secondary|Progression Free Survival (PFS)|Time from the date of randomization to the date of the first documented radiological progression (as defined per independent central radiological assessment) or death, whichever occurs first|from date of randomization of the first patient until 3 years later|The ITT population, primary population for efficacy analysis, includes all randomized patients.||days||95% Confidence Interval|Median
706540|NCT00108953|Secondary|Overall Survival|The time from date of randomization to date of death|from date of randomization of the first patient until 3 years later|The ITT population, primary population for efficacy analysis, includes all randomized patients. The table below gives the lower and upper limit of the confidence interval; 999999999 = not estimable.||days||95% Confidence Interval|Median
706541|NCT00108953|Primary|Time to Progression (TTP)|TTP was defined as the time from randomization to radiological disease progression by independent assessment.|from date of randomization of the first patient until 3 years later|The intent-to-treat (ITT) population, primary population for efficacy analysis, includes all randomized patients.||days||95% Confidence Interval|Median
706542|NCT00109005|Secondary|Evaluate Effects of Lenalidomide on Pathways|Tissue will be obtained to evaluate the effects of lenalidomide on pathways thought to be modulated by lenalidomide.|Baseline and at the end of treatment cycles 3 and 6. Every 21 day supply of lenalidomide with a 7 day rest (total of 28 days) will be considered a cycle of therapy.|This outcome measure was not analyzed because the investigator left the institution.|||||
706543|NCT00109005|Secondary|Determine Dose Level With Superior Efficacy and Acceptable Toxicity|The most efficacious dose (with greater number of responses) with acceptable toxicity profile will be considered for use in subsequent trials. iI the number of responses is tied, then toxicity criteria (Common Terminology criteria (CTC) v3.0) will be used to select the preferred dose.|up to 2 years|This outcome measure was not analyzed because the investigator left the institution.|||||
706544|NCT00109005|Secondary|Determine Pharmacokinetics of Lenalidomide at Two Dose Levels: 5 mg and 25 mg|Plasma samples will be obtained and plasma concentrations will be determined by a reversed-phase high-performance liquid chromatography (HPLC) assay using mass spectrometry (MS) detection.|Prior to treatment on cycle 1, day 1 and then on cycle 1, day 1 at 0.25, 0.5, 1, 2, 4, 6, 9 and 12 hours. Cycle 1, day 2 at 24 hours.|This outcome measure was not analyzed because the investigator left the institution.|||||
706545|NCT00109005|Secondary|Overall Survival|Date of on-study to the date of death from any cause or last follow up.|up to 2 years|This outcome measure was not analyzed because the investigator left the institution.|||||
706546|NCT00109005|Secondary|Progression Free Survival|Time interval from start of treatment to documented evidence of disease progression.|up to 2 years|This outcome measure was not analyzed because the investigator left the institution.|||||
706547|NCT00109005|Primary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|24 months|||Participants|||Number
706548|NCT00109005|Primary|Clinical Responses in Patients With Metastatic Ocular Melanoma|Clinical response is assessed by the Response Evaluation Criteria for Adverse Events in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|12 months|"Response data was combined for this outcome measure. Results are available for the combined cohorts only.
Sixteen out of seventeen patients were eligible for response assessments."||Participants|||Number
706549|NCT00109031|Secondary|Number of Participants With WHO Grade 4 Oral Mucositis|Participants underwent evaluations of oral mucosal (OM) surfaces (mucositis assessments) daily during hospitalization and daily thereafter until OM returned to grade ≤ 2. A trained evaluator documented the findings using the World Health Organization (WHO) oral toxicity scale according to the following: Grade 0 = None; Grade 1 = Soreness, erythema; Grade 2 = Erythema, ulcers, ability to eat solids; Grade 3 = Ulcers, requires liquid diet; Grade 4 = Alimentation not possible.|Up to Day 28|Primary analysis set||participants|||Number
706550|NCT00109031|Secondary|Duration of WHO Grade 2, 3 or 4 Oral Mucositis|"The duration of grade 2, 3 or 4 oral mucositis (OM) was calculated as the number of days from the onset of grade 2, 3 or 4 OM (first time a WHO grade 2, 3 or 4 was observed) to the day when WHO grade 2 - 4 OM was resolved (first time WHO grade less than 2 was observed after last WHO grade 2, 3 or 4). Durations of 0 days were assigned to those participants who did not experience any WHO grade 2, 3 or 4 during the study.
OM was evaluated using the World Health Organization (WHO) oral toxicity scale according to the following: Grade 0 = None; Grade 1 = Soreness, erythema; Grade 2 = Erythema, ulcers, ability to eat solids; Grade 3 = Ulcers, requires liquid diet; Grade 4 = Alimentation not possible."|Up to Day 28|Primary analysis set with available OM assessment data||days||Standard Deviation|Mean
710938|NCT00168844|Secondary|Change From Baseline in Eosinophils|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||percentage of white blood cell count||Standard Deviation|Mean
706551|NCT00109031|Secondary|Number of Participants With WHO Grades 2, 3 or 4 Oral Mucositis|Participants underwent evaluations of oral mucosal (OM) surfaces (mucositis assessments) daily during hospitalization and daily thereafter until OM returned to grade ≤ 2. A trained evaluator documented the findings using the World Health Organization (WHO) oral toxicity scale according to the following: Grade 0 = None; Grade 1 = Soreness, erythema; Grade 2 = Erythema, ulcers, ability to eat solids; Grade 3 = Ulcers, requires liquid diet; Grade 4 = Alimentation not possible.|Up to Day 28|Primary analysis set||participants|||Number
706552|NCT00109031|Secondary|Number of Participants With Parenteral or Transdermal Opioid Analgesic Use|Includes nonprophylactic intravenous opioid analgesics (fentanyl, morphine, morphine sulphate, hydromorphone, meperidine) and transdermal opioid analgesics (fentanyl patch) for the indication of oral mucositis and dysphagia.|Up to Day 28|Primary analysis set||participants|||Number
706553|NCT00109031|Secondary|Area Under the Curve (AUC) of Mouth and Throat Soreness Score|"The Oral Mucositis Daily Questionnaire (OMDQ) is a self-reported tool that evaluates overall health, mouth and throat soreness (MTS) and activity limitations due to MTS. The OMDQ was completed once daily beginning with the first day of study drug administration through Day 28. The area under the curve of mouth and throat soreness score was assessed from the question How much mouth and throat soreness did you experience in the past 24 hours? Participants answered on a scale from 0 (no soreness) to 4 (extreme soreness). A higher value in MTS AUC indicates worse self-assessed MTS."|From the first day of study drug administration through Day 28|Primary analysis set with available MTS data||MTS score * days||Standard Deviation|Mean
706554|NCT00109031|Secondary|Duration of Severe Oral Mucositis (WHO Grade 3 and 4)|The duration of severe oral mucositis (OM) was calculated as the number of days from the onset of severe OM (first time a WHO grade 3 or 4 was observed) to the day when severe OM was resolved (first time WHO grade 2 or less was observed after last WHO grade 3 or 4). Durations of 0 days were assigned to those participants who did not experience any WHO grade 3 or 4 during the study.|Up to Day 28|Primary analysis set||days||Standard Deviation|Mean
706555|NCT00109031|Primary|Number of Participants With Severe Oral Mucositis (WHO Grade 3 and 4)|Participants underwent evaluations of oral mucosal (OM) surfaces (mucositis assessments) daily during hospitalization and daily thereafter until severe OM returned to grade ≤ 2. A trained evaluator documented the findings using the World Health Organization (WHO) oral toxicity scale according to the following: Grade 0 = None; Grade 1 = Soreness, erythema; Grade 2 = Erythema, ulcers, ability to eat solids; Grade 3 = Ulcers, requires liquid diet; Grade 4 = Alimentation not possible.|Up to Day 28|Primary analysis set||participants|||Number
706556|NCT00109343|Primary|Antibody Response to S. Pneumoniae Serotype 23F – Geometric Mean Titer|Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 23F|6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.||mcg/mL||95% Confidence Interval|Geometric Mean
706557|NCT00109343|Primary|Antibody Response to S. Pneumoniae Serotype 19F – Geometric Mean Titer|Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 19F|6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.||mcg/mL||95% Confidence Interval|Geometric Mean
706558|NCT00109343|Primary|Antibody Response to S. Pneumoniae Serotype 18C – Geometric Mean Titer|Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 18C|6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.||mcg/mL||95% Confidence Interval|Geometric Mean
706559|NCT00109343|Primary|Antibody Response to S. Pneumoniae Serotype 14 – Geometric Mean Titer|Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 14|6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.||mcg/mL||95% Confidence Interval|Geometric Mean
706560|NCT00109343|Primary|Antibody Response to S. Pneumoniae Serotype 9V – Geometric Mean Titer|Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 9V|6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.||mcg/mL||95% Confidence Interval|Geometric Mean
706561|NCT00109343|Primary|Antibody Response to S. Pneumoniae Serotype 6B – Geometric Mean Titer|Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 6B|6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone.|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.||mcg/mL||95% Confidence Interval|Geometric Mean
706562|NCT00109343|Primary|Antibody Response to S. Pneumoniae Serotype 4 – Geometric Mean Titer|Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 4|6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.||mcg/mL||95% Confidence Interval|Geometric Mean
706563|NCT00109343|Other Pre-specified|Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 23F||6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.||Participants|||Number
706564|NCT00109343|Other Pre-specified|Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 19F||6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.||Participants|||Number
706565|NCT00109343|Other Pre-specified|Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 18C||6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.||Participants|||Number
706566|NCT00109343|Other Pre-specified|Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 14||6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.||Participants|||Number
706567|NCT00109343|Other Pre-specified|Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 9V||6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.||Participants|||Number
706568|NCT00109343|Other Pre-specified|Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 6B||6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.||Participants|||Number
706569|NCT00109343|Other Pre-specified|Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 4||6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.||Participants|||Number
706570|NCT00109343|Primary|Number of Participants With Postvaccination Varicella Antibody Titer ≥1.25 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL and ≥5 gpELISA Units/mL|Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially With Varicella Antibody Titer <1.25 gpELISA units/mL at Baseline|6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, Varicella Antibody Titer <1.25 gpELISA units/mL at baseline, and followed protocol procedures.||Participants|||Number
706571|NCT00109343|Primary|Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL|Antibody Response to Rubella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <10 IU/mL) to Rubella at Baseline.|6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to rubella at baseline, and followed protocol procedures.||Participants|||Number
706572|NCT00109343|Primary|Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥10 Ab Units/mL|Antibody Response to Mumps at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <10 ELISA Ab units/mL) to Mumps at Baseline.|6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to mumps at baseline, and followed protocol procedures.||Participants|||Number
706573|NCT00109343|Primary|Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥255 mIU/mL|Antibody Response to Measles at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <255 mIU/mL) to Measles at Baseline.|6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to measles at baseline, and followed protocol procedures.||Participants|||Number
706574|NCT00109473|Secondary|Fecal Calprotectin|Fecal calprotectin is a previously validated stool marker of intestinal inflammation in Crohn's Disease.|At 24 and 64 weeks|||micrograms per gram (microg/g)||95% Confidence Interval|Mean
706575|NCT00109473|Secondary|Height Velocity|"Height velocity was computed every 12 weeks up to week 64 and then yearly during the Maintenance study. Since 40 to 80% of children with Crohn's disease have significant growth failure at diagnosis, height velocity is used to track for changes in height.
It is calculated by measuring height at two points of time and then dividing the change by the amount of time."|Baseline, week 12, 24 and 48|||cm/year||Standard Error|Mean
706576|NCT00109473|Secondary|Crohn's Disease Endoscopic Index of Severity (CDEIS)|Measure of mucosal disease at baseline and week 12 obtained during colonoscopy. The CDEIS score generally ranges from 0–30. A higher score indicates more severe mucosal inflammation.|Baseline and 12 weeks|||Scores on a scale||95% Confidence Interval|Mean
706577|NCT00109473|Secondary|Total Corticosteroid Use||12 weeks, 24 weeks||||||
706578|NCT00109473|Secondary|Pediatric Crohn's Disease Activity Index (PCDAI)|The PCDAI is a previously validated measure of clinical disease activity for children with CD. It contains three self-report items which reflect patient abdominal pain, diarrhea, and general well being; three laboratory values; height and weight velocity; and three physical examination parameters reflecting abdominal tenderness, perirectal disease, and extra-intestinal manifestations. Scores may range from 0-100. Remission is defined as 0-10, mild disease as 10-30, and moderate to severe disease as greater than 30.|Baseline, 12 and 24 weeks|||Scores on a scale||95% Confidence Interval|Mean
706580|NCT00109473|Secondary|Serum IGF-1 (Insulin-like Growth Factor 1)z Score|"Elevated serum IGF-1 levels have been implicated in the development of colorectal cancer, both in the general population and in patients with an excess of growth hormone production. The serum IGF-1 levels were monitored to maintain them in the physiologic range during growth hormone therapy to reduce the risk of tumorigenesis.
The levels are reported as a z score, a statistical way of standardizing data. The standard deviation is the unit of measurement of the z-score. Each z score corresponds to a point in a normal distribution, describing how much a point deviates from a mean."|Baseline, 12 weeks, 24 weeks|||Z score||Standard Error|Mean
706581|NCT00109473|Primary|Crohn's Disease Histologic Index of Severity (CDHIS)|The CDHIS was developed and validated in order to determine the effect of therapies upon histologic disease activity in Crohn's Disease. It has been used to assess mucosal healing in response to infliximab and 6-MP/AZA.It contains eight items which reflect epithelial injury, mucosal inflammation, and the extent of involvement. Scores range from 0-16, with patients with moderate to severely active CD typically having scores of 6-12. It was computed by a GI pathologist. The higher the score indicates worsening of disease, the lowest score is 0 and highest possible is 16|Baseline and 12 weeks|||scores on a scale||95% Confidence Interval|Number
706582|NCT00109577|Secondary|Medical Outcomes Study 36-Item Short Form Health Survey (SF-36)||Baseline to 8 weeks||||||
706583|NCT00109577|Secondary|Outcome Questionnaire --- a Self-report Questionnaire||Baseline to 8 weeks||||||
706584|NCT00109577|Secondary|Global Clinical Impressions||Baseline to 8 weeks||||||
706585|NCT00109577|Primary|Mood as Evaluated by the Overall Bipolarity Index (Composite of the Hamilton Depression Scale and the Young Mania Rating Scale)|Change in mood from baseline to final visit, as evaluated by the Overall Bipolarity Index (composite of the Hamilton Depression Scale and the Young Mania Rating Scale); minimum possible score is 0 and maximum possible score is 103; higher scores mean worse symptomatology|Baseline to 8 weeks|All participants were included, since the analysis was intent-to-treat with last observation carried forward||units on a scale||Standard Deviation|Mean
706586|NCT00109590|Primary|Four (4) Hour Concentration Pharmacokinetic Outcome for LPV/r (C4hour ug/mL).|Data was analyzed with WinNonLin (Version 5.2, Pharsight, USA) using non-compartmental methods. The pharmacokinetic parameters were calculated using the linear-trapezoidal rule. Cpredose and C4hour at the two measurement times were compared within-subject using the Wilcoxon signed-rank test.|Within 72 hours postpartum and during the first 30 days postpartum|18 women were enrolled in this sub study,PK sampling was not performed in 2 women. Of the remaining 16 women, all completed the LPV/r PK sampling within 72 hours after delivery and at day 30 postpartum and had evaluable PK within 72 hours delivery but only 14 women had evaluable PK results at day 30 postpartum due to suspected poor drug adherence.||ug/mL||Full Range|Median
706587|NCT00109590|Primary|Pre-dose Concentration Pharmacokinetic Outcome for LPV/r (Cpredose ug/mL).|Data was analyzed with WinNonLin (Version 5.2, Pharsight, USA) using non-compartmental methods. The pharmacokinetic parameters were calculated using the linear-trapezoidal rule. Cpredose and C4hour at the two measurement times were compared within-subject using the Wilcoxon signed-rank test.|Within 72 hours postpartum and during the first 30 days postpartum|18 women were enrolled in this sub study,PK sampling was not performed in 2 women. Of the remaining 16 women, all completed the LPV/r PK sampling within 72 hours after delivery and at day 30 postpartum and had evaluable PK within 72 hours delivery but only 14 women had evaluable PK results at day 30 postpartum due to suspected poor drug adherence.||ug/mL||Full Range|Median
706588|NCT00109590|Primary|Maximum Concentration Pharmacokinetic Outcome for LPV/r (Cmax ug/mL) .|Data was analyzed with WinNonLin (Version 5.2, Pharsight, USA) using non-compartmental methods. The pharmacokinetic parameters were calculated using the linear-trapezoidal rule. Cpredose and C4hour at the two measurement times were compared within-subject using the Wilcoxon signed-rank test.|Within 72 hours postpartum and during the first 30 days postpartum|18 women were enrolled in this sub study,PK sampling was not performed in 2 women. Of the remaining 16 women, all completed the LPV/r PK sampling within 72 hours after delivery and at day 30 postpartum and had evaluable PK within 72 hours delivery but only 14 women had evaluable PK results at day 30 postpartum due to suspected poor drug adherence.||ug/mL||Full Range|Median
706589|NCT00109590|Secondary|Median Viral Load (log10 Copies/ml) at 24 Weeks Postpartum in Women||at 24 weeks postpartum|The number of particpants included in this analyses were for those for whom viral loads were available at 24 weeeks postpartum.||participants||Full Range|Median
706590|NCT00109590|Secondary|Resistance Mutations in HIV Infected Infants|Resistance mutations as identified by consensus sequencing or OLA|24 weeks postpartum|Amongst the infants who became HIV-infected.||participants|||Number
706591|NCT00109590|Secondary|Proportion of Women With New NVP Resistance Mutation Within 8 Weeks Postpartum Who Had a NVP Resistance Mutation Detected at 72 Weeks Postpartum.|Resistance mutations as identified by OLA in plasma samples or PBMC at 72 weeks postpartum amongst women who had new NVP resistance mutations within 8 weeks postpatrum. These results were based on the 13 women who developed a new NVP resistance mutation in the first 8 weeks postpartum. For the primary outcome measure 1, one particpant in arm A was unavailable for follow-up after week 5 and was conservatively imputed to have developed resistance mutation.|within 72 weeks postpartum|amongst the participants who developed resistance within 8 weeks postpartum||participants|||Number
706592|NCT00109590|Secondary|Number of Women With Grade >=3 Events After Start of Study Treatment|Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading > the Severity of Adult and Pediatric Adverse Events (December 2004). All grade 3 and higher signs, symptoms, and laboratory toxicities (and events of any grade that led to a change in study treatment) were included.|After start of study Treatment (postpartum)|All women who started treatment were included in an intention-to-treat analysis.||participants|||Number
706593|NCT00109590|Secondary|The Proportion of Women With Any New ZDV, ddI, or LPV/r Resistance Mutations.||At Week 5 postpartum (ZDV) and at the first timepoint with viral load >=500 copies/ml after treatment discontinuation (ddI and LPV/r).|All women who started treatment were included in an intention-to-treat analysis||percent of participants|||Number
706608|NCT00109772|Secondary|Change From Baseline in the Profile of Mood States (POMS) at Week 12|Participants completed the Profile of Mood States questionnaire that asks participants to rate how each of 65 words reflected their mood in the past week on a 5-point scale with 0=not at all and 4=extremely for a total scale of 0-260. Week 12 values are compared to baseline values. Negative change values indicate improvement.|Day 0, week 12|Intent to treat population. Last observation carried forward. Six participants had no post-treatment values.||units on a scale||Standard Deviation|Mean
706594|NCT00109590|Secondary|The Proportion of Women in Each Randomized Arm Who Have One or More New NVP Resistance Mutations for the Subgroup of Women With Plasma HIV RNA >= 500 Copies/ml At Entry|The incidence of new NVP resistance mutations at day 10 or week 6 postpartum in each randomized arm. Samples with viral load <500 copies/mL were considered free of mutations. If a resistance result was missing for reasons other than VL <500 copies/ml it was conservatively imputed as resistant in the primary analysis.|at Day 10 or Week 6 postpartum.|Includes only the Subgroup of women with Plasma HIV RNA >= 500 copies/ml at Entry and who started treatment; analyzed using the intention-to-treat principle (according to assigned treatment, regardless of compliance with the protocol).||percent of participants||95% Confidence Interval|Number
706595|NCT00109590|Primary|Area Under the Curve Pharmacokinetic Outcome for LPV/r. (AUC ug*hr/mL)|Data was analyzed with WinNonLin (Version 5.2, Pharsight, USA) using non-compartmental methods. The pharmacokinetic parameters were calculated using the linear-trapezoidal rule. Cpredose and C4hour at the two measurement times were compared within-subject using the Wilcoxon signed-rank test.|Within 72 hours postpartum and during the first 30 days postpartum|18 women were enrolled in this sub study,PK sampling was not performed in 2 women. Of the remaining 16 women, all completed the LPV/r PK sampling within 72 hours after delivery and at day 30 postpartum and had evaluable PK within 72 hours delivery but only 14 women had evaluable PK results at day 30 postpartum due to suspected poor drug adherence.||ug*hr/mL||Full Range|Median
706596|NCT00109590|Primary|The Proportion of Women in Each Randomized Arm Who Have One or More New NVP Resistance Mutations as Identified by Consensus Sequencing or Oligonucleotide Ligation Assay (OLA) in Plasma|The incidence of new NVP resistance mutations at day 10 or week 6 postpartum in each randomized arm. Samples with viral load <500 copies/mL were considered free of mutations. If a resistance result was missing for reasons other than VL <500 copies/ml it was conservatively imputed as resistant in the primary analysis.|at Day 10 or Week 6 postpartum.|All women who started treatment were included in an intention-to-treat analysis (according to randomized treatment assignment, regardless of compliance with the protocol)||percent of participants||95% Confidence Interval|Number
706597|NCT00109590|Primary|The Proportion of Women Who Develop One or More New NVP Resistance Mutations as Identified by Consensus Sequencing or Oligonucleotide Ligation Assay in Plasma (Sampling Was Done at Days 10,21,30, and Weeks 5,6, and 8 Postpartum).|The incidence of new NVP resistance mutation in plasma HIV within 8 weeks postpartum in each randomized arm was estimated using an exact binomial confidence interval. If a resistance mutation was detected at any of the timepoints then an endpoint was met. Samples with VL <500 copies/mL were considered free of mutations. If a resistance result was missing for reasons other than VL <500 copies/ml (e.g.missed visit), it was conservatively imputed as resistant in the primary analysis.|within 8 weeks postpartum.|All women who started treatment were included in an intention-to-treat analysis.||percent of participants||95% Confidence Interval|Number
706598|NCT00109733|Secondary|Percent Change From Baseline to Week 24 in Trunk to Limb Fat Ratio||Baseline to Week 24|Intention To Treat, Last Observation Carried Forward||percent change||Standard Deviation|Mean
706599|NCT00109733|Secondary|Percent Change From Baseline to Week 24 in Limb Fat||Baseline to Week 24|Intention To Treat, Last Observation Carried Forward||percent change||Standard Deviation|Mean
706600|NCT00109733|Secondary|Percent Change From Baseline to Week 24 in Total Body Fat||Baseline to Week 24|Intention To Treat, Last Observation Carried Forward||percent change||Standard Deviation|Mean
706601|NCT00109733|Secondary|Percent Change From Baseline to Week 24 in Lean Body Mass||Baseline to Week 24|Intention To Treat, Last Observation Carried Forward||percent change||Standard Deviation|Mean
706602|NCT00109733|Primary|Percent Change From Baseline to Week 24 in Trunk Fat||Baseline to Week 24|Intention To Treat, Last Observation Carried Forward||percent change||Standard Deviation|Mean
706603|NCT00109772|Secondary|Participants With Treatment-Emergent Adverse Events in the Double-Blind Period or the Extension Period|"Counts of study participants who had adverse events (AEs) while treated in either the Double-blind or Extension Periods. The NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 was used by the investigator to grade the severity of the AEs: Grade 1=Mild AE, Grade 2=Moderate AE, Grade 3=Severe AE, Grade 4=Life-threatening or disabling AE, Grade 5=Death related to AE.
AEs are also summarized by whether they were serious, related to treatment and whether the AE caused treatment to be altered.
A serious AE (SAE) was any event that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity or congenital anomaly/birth defect or was an important medical event could have jeopardized the patient's safety or required medical or surgical intervention to prevent one of the outcomes listed above."|Day 1 up to week 158|Safety population||participants|||Number
706604|NCT00109772|Secondary|Change From Baseline in the Maximal Composite Sensory Nerve Conduction Velocity at Week 12|An electrophysiological evaluation using standard electrophysiological and electromyography to measure the speed and extent of nerve conduction. Week 12 values are compared to baseline values for maximal sensory nerve conduct velocity.|Day 0, week 12|Intent to treat population. Fifty participants did not have week 12 values.||meters/second||Standard Deviation|Mean
706605|NCT00109772|Secondary|Change From Baseline in the Maximal Composite Motor Nerve Conduction Velocity at Week 12|An electrophysiological evaluation using standard electrophysiological and electromyography to measure the speed and extent of nerve conduction. Week 12 values are compared to baseline values for maximal motor nerve conduct velocity.|Day 0, week 12|Intent to treat population. Fifty participants did not have week 12 values.||meters/second||Standard Deviation|Mean
706606|NCT00109772|Secondary|Participants Who Had a Change to CRPS Pain Medication During the Treatment Period|Participants who had any change in CRPS medication during the double-blind treatment period (up to week 12) are summarized. Changes include additions, discontinuations or dosage change of CRPS medication(s).|Day 1 to week 12|Intent to treat population||participants|||Number
706607|NCT00109772|Secondary|Patient Global Impression of Change (PGIC) at Week 12|The Patient Global Impression of Change asks the question: Overall, how would you rate your CRPS condition since the start of study drug? Answers are represented on a seven-point scale with -3=much worst and +3=much better.|Week 12|Intent to treat. Forty-five participants had no week 12 values.||units on a scale||Standard Deviation|Mean
706807|NCT00116831|Secondary|Change From Baseline to Month 18 in LDL-c Peak Particle Density Measured by LDL Relative Flotation|From repeated measures analysis model: Change = baseline + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.|Baseline to Month 18|ITT Population without LOCF||Ratio||Standard Error|Mean
706609|NCT00109772|Secondary|Change From Baseline in the Brief Pain Inventory (BPI) Total Score at Week 12|Participants completed the Brief Pain Inventory which asks twelve questions that are rated on an eleven-point scale in which 0=most positive outcome and 10=the most negative outcome for a total scale of 0-120. BPI contains questions that concern the level of pain over the last week and the level of pain right now, the extent to which pain interfered with sleep, normal activities, ability to work, relationships, walking etc. Week 12 values are compared to baseline values. Negative change values indicate improvement.|Day 0, week 12|Intent to treat population. Last observation carried forward. Three participants had no post-treatment values.||units on a scale||Standard Deviation|Mean
706610|NCT00109772|Secondary|Difference in Allodynia Rating Between the CRPS-affected Limb and the Normal Limb at Week 12|The investigator rated the degree of allodynia on both the CRPS-affected limb and the normal (or less-affected) limb on an eleven-point scale where 0=no pain and 10=worst pain imaginable. This outcome compares the values for the CRPS affected-limb to the normal limb at week 12.|Week 12|Intent to treat population. Last observation carried forward. Fifteen participants were missing values.||units on a scale||Standard Deviation|Mean
706611|NCT00109772|Secondary|Change From Baseline in “Mechanically Evoked” (Allodynia) Numeric Rating Scale (NRS) Score at Week 12|The investigator rated the degree of allodynia on both the CRPS-affected limb on an eleven-point scale where 0=no pain and 10=worst pain imaginable. This outcome compares the baseline values for the CRPS affected-limb to the values at week 12. Negative change values indicate improvement.|Day 0, week 12|Intent to treat population. Last observation carried forward. Sixteen participants had either no baseline or post-treatment values.||units on a scale||Standard Deviation|Mean
706612|NCT00109772|Secondary|Change From Baseline in Participant Assessment of CRPS Symptoms Total Score at Week 12|Participants rated twelve CRPS symptoms using a four-point rating scale in which 1=the most positive outcome and 4= the most negative outcome for a total scale of 12-48. Week 12 values are compared to baseline values. Negative change values indicate improvement.|Day 0, week 12|Intent to treat population. Last observation carried forward. Thirty-three participants had either no baseline or post-treatment values.||units on a scale||Standard Deviation|Mean
706613|NCT00109772|Secondary|Change From Baseline in Activity Level Rating Using a Numeric Rating Scale (NRS) at Week 12|Participants rated how the activity level on a given day compares with their activity level prior to the start of treatment. A seven-point scale is used with -3=much worse and +3=much better. Positive change values indicate improvement.|Day 0, week 12|Intent to treat population. Last observation carried forward. Three participants had no post-treatment values.||units on a scale||Standard Deviation|Mean
706614|NCT00109772|Secondary|Change From Baseline in Daily Sleep Assessment Average Score at Week 12|Participants rated how much CRPS pain interfered with their sleep each day in a diary. The Sleep Assessment uses an eleven point scale for four questions. Questions concern ability to fall asleep, ability to stay asleep, how refreshed the participant feels upon waking and how alert the participant is during the day. All use a scale of 0-10, where the higher number is the positive response (e.g. 0=Pain completely interferes with sleep and 10=Pain does not interfere). The mean of all four responses was calculated if at least 3 of the 4 questions had a value. Week 12 values are compared to baseline values. Positive change values indicate improvement.|Day 0, week 12|Intent to treat population. Last observation carried forward. Three participants had no post-treatment values.||units on a scale||Standard Deviation|Mean
706615|NCT00109772|Secondary|Change From Baseline in the Evening Complex Regional Pain Syndrome (CRPS) Pain Intensity Numeric Rating Scale (PI-NRS) Score at Week 12|Participants rated the intensity of pain in the CRPS-affected limb twice each day in a diary. The PI-NRS is an eleven point scale with 0=no pain and 10=worst pain imaginable. The evening pain ratings at baseline and Week 12 are compared. Negative changes indicate improvement in level of pain.|Day 0, week 12|Intent to treat population. Last observation carried forward. Three participants had no post-treatment values.||units on a scale||Standard Deviation|Mean
706616|NCT00109772|Secondary|Change From Baseline in the Morning Complex Regional Pain Syndrome (CRPS) Pain Intensity Numeric Rating Scale (PI-NRS) Score at Week 12|Participants rated the intensity of pain in the CRPS-affected limb twice each day in a diary. The PI-NRS is an eleven point scale with 0=no pain and 10=worst pain imaginable. The morning pain ratings at baseline and Week 12 are compared. Negative changes indicate improvement in level of pain.|Day 0, week 12|Intent to treat population. Last observation carried forward. Three participants had no post-treatment values.||units on a scale||Standard Deviation|Mean
706617|NCT00109772|Secondary|Change From Baseline in the Complex Regional Pain Syndrome (CRPS) Pain Intensity Numeric Rating Scale (PI-NRS) Score Using Averaged Morning and Evening Readings at Week 12|Participants rated the intensity of pain in the CRPS-affected limb twice each day in a diary. Morning and evening scores are averaged. The PI-NRS is an eleven point scale with 0=no pain and 10=worst pain imaginable. Week 12 values are compared to baseline values. Negative changes indicate improvement in level of pain.|Day 0, week 12|Intent to treat population. Last observation carried forward. Three participants had no post-treatment values.||units on a scale||Standard Deviation|Mean
706618|NCT00109772|Secondary|Change From Baseline in the Total Score of the Short Form McGill Pain Questionnaire (SF-MPQ) at Week 12|Short Form McGill Pain Questionnaire (SF-MPQ) is comprised of 15 pain qualities that are rated by the participant on a 4 point scale with 0=none and 3=severe. The scale for the Total Score is 0-45. Week 12 values are compared to baseline values. Negative changes indicate improvement in level of pain.|Day 0, week 12|Intent to treat. Last observation carried forward. Three participants had no post-treatment values.||units on a scale||Standard Deviation|Mean
706619|NCT00109772|Primary|Percentage of Participants Who Have a >= 30% Reduction (Improvement) in the Complex Regional Pain Syndrome (CRPS) Pain Intensity Numeric Rating Scale (PI-NRS) Score From Baseline to the Last Assessment|Participants rated the intensity of pain in the CRPS-affected limb twice each day in a diary. The PI-NRS is an eleven point scale with 0=no pain and 10=worst pain imaginable. Responders are participants who completed 12 weeks of treatment and their week 12 PI-NRS score showed at least a 30% improvement from baseline. Participants who did not complete 12 weeks of treatment are considered non-responders.|Day 0, Week 12|Intent to treat||percentage of participants|||Number
706620|NCT00109837|Secondary|Toxicity|Number of patients with Grade 3-5 adverse events that are related to study drug by given type of adverse event|Patients were assessed for adverse events after the induction cycle|Eligible patients who started therapy||Participants with a given type of AE|||Number
706621|NCT00109837|Primary|Continuous Complete Remission at 1 Year|A patient has a continuous complete remission at 1 year if they achieve a CR and are alive 365 days after registering to the study.|After induction, after consolidation, every 3 months during maintenance, and every three months after off treatment for up to a year|Eligible, Ph-, treated, and evaluable patients||participants|||Number
706622|NCT00109850|Secondary|Progression Free Survival|Measured from date of registration to date of first observation of progression or symptomatic deterioration. Patients last known to be alive and progression-free are censored at date of last contact.|0 - 5 years|All eligible patients who started treatment were included in the analysis.||months||95% Confidence Interval|Median
706623|NCT00109850|Secondary|Objective Response (Confirmed and Unconfined, Complete and Partial)|Complete response (CR) is complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Normalization of markers and other abnormal lab values. Partial response (PR) applies only to patients with at least one measurable lesion. Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration.|at week 16, then every 3 months until progression|All eligible patients who started treatment and were evaluable for response were included in assessing response estimates.||percentage of participants||95% Confidence Interval|Number
706624|NCT00109850|Secondary|Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|Patients were assessed for adverse events after every two cycles of chemotherapy.|Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.||Participants|||Number
706625|NCT00109850|Primary|Overall Survival at 2 Years|Measured from time of registration to date of death due to any cause, or last contact date|0-2 years|All eligible patients who started treatment were included in the analysis.||percentage of participants||95% Confidence Interval|Number
706626|NCT00109876|Secondary|Change in Pulmonary Function From Baseline at Month 24|Pulmonary function test values include forced expiratory volume 1 (FEV1) and carbon monoxide diffusion (DLCO). The distribution of clinically meaningful changes (10% increase or 10% decrease) in pulmonary function from the baseline to 24 was summarized.|Baseline and Month 24|All enrolled participants who met the eligibility criteria.||Participants|||Count of Participants
706627|NCT00109876|Secondary|Change in Pulmonary Function From Baseline at Month 3|Pulmonary function test values include forced expiratory volume 1 (FEV1) and carbon monoxide diffusion (DLCO). The distribution of clinically meaningful changes (10% increase or 10% decrease) in pulmonary function from the baseline to 3 was summarized.|Baseline and Month 3|All enrolled participants who met the eligibility criteria.||Participants|||Count of Participants
706628|NCT00109876|Secondary|Incidence of Adverse Events|The National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 was used to evaluate adverse event. > Grade 1: mild; Grade 2: moderate; Grade 3: Severe; Grade 4: Life Threatening; Grade 5: Death.|Up to 2 years|All enrolled participants who met the eligibility criteria.||Participants|||Count of Participants
706629|NCT00109876|Secondary|Number of Procedures Deemed Technical Successes|The number of procedures deemed technical successes is defined as the number of patients with a RFA procedures deemed a technical success. A technical success is defined as follows: The pertinent captured images from the treatment CT showing RFA electrode placement and the recorded RFA generator parameters (e.g. impedance, current, power, treatment time and maximum intra-tumoral temperature) were reviewed by the quality control panel to determine technical success.|Up to 2 years|All enrolled participants who met the eligibility criteria.||number of technical successes|||Number
706630|NCT00109876|Secondary|Overall Time to Recurrence|The overall time to recurrence was defined as the time from registration to documentation of disease recurrence. If a patient dies without a documentation of disease recurrence, the patient will be considered to have had tumor recurrence at the time of their death unless there is sufficient evidence to conclude no recurrence occurred prior to death.|Up to 2 years|All enrolled participants who met the eligibility criteria.||years||95% Confidence Interval|Median
706631|NCT00109876|Secondary|Overall Time to Local Failure|The overall time to local failure was defined as the time from registration to documentation of > local failure. The local failure was defined as the recurrence in the same lobe or hilum (N1 nodes) or progression at the ablated site after treatment affects have subsided.|Up to 2 years|All enrolled participants who met the eligibility criteria.||years||95% Confidence Interval|Median
706632|NCT00109876|Primary|Overall Survival at 2 Years|Percentage of participants who were alive at 2 years. The 2 year survival was estimated using the Kaplan Meier method.|2 years from registration|All enrolled participants who met the eligibility criteria.||percentage of participants||95% Confidence Interval|Number
706633|NCT00109928|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|up to 18 weeks of protocol treatment|Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.||Participants|||Number
706634|NCT00109928|Secondary|Response Rate|Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.|up to 3 years or time of disease progression|All eligible patients who started protocol treatment were included in the analysis.||participants|||Number
706635|NCT00109928|Secondary|2-year Progression-free Survival Rate|Progression-free survival rate is the percentage of patients who do not show signs of progression at 2 years after registration to the study, including those whose disease has either completely or partially responded to treatment, or those whose disease is stable. Progression-free survival is defined as the time between study registration and documented progression, or death if no progression was observed.|0-2 years|All eligible patients who started protocol treatment were included in the analysis.||percentage of participants||95% Confidence Interval|Number
706636|NCT00109928|Primary|2-year Overall Survival Rate|The overall survival rate is the percentage of patients who are alive 2 years after registration to the study. Overall survival is defined as the time between study registration and death due to any cause.|0-2 years|All eligible patients who started protocol treatment were included in the analysis||percentage of participants||95% Confidence Interval|Number
706637|NCT00109967|Secondary|Overall Survival|Overall survival (OS) was defined as the time from registration to death resulting from any cause. The distribution of this time-to-event end point was estimated using the Kaplan-Meier method.|Patients were followed for survival status for up to 5 years.|||months||95% Confidence Interval|Median
706638|NCT00109967|Secondary|Toxicity|"As per the National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTCAE) Version 3, toxicity was defined as adverse events that are classified as either possibly, probably, or definitely related to study treatment by the treating physician.
In this section, we report the number of participants that experienced at least one Grade 3 or higher adverse event."|Assessed during treatment (up to 12, 28-day cycles)|||patients|||Number
706639|NCT00109967|Secondary|Duration of Response|Duration of response was defined as the time from the date of documented response to the date of progression. Patients who went off treatment due to other reasons (eg, adverse reactions, refusal of further treatment) were censored at that time. The distribution of this time-to-event end point was estimated using the Kaplan-Meier method.|Response duration is followed up to 5 years from registration.|Of the 48 Rituximab Sensitive patients, 30 patients had a response. Of the 21 Rituximab Refractory patients, 11 patients had a response. Therefore, this endpoint uses 30 patients from the Rituximab Sensitive group and 11 patients from the Rituximab Refractory group in the analysis.||months||95% Confidence Interval|Median
706640|NCT00109967|Secondary|Time to Progression|Time to progression was defined as the time from registration to the date of progression. Patients who died without disease progression were censored at the date of their last evaluation. Patients who were still receiving treatment at the time of these analyses were censored at the date of their last evaluation. The distribution of this time-to-event end point was estimated using the Kaplan-Meier method.|Patients were followed up to five years after registration.|||months||95% Confidence Interval|Median
706641|NCT00109967|Primary|Overall Response Rate (Complete and Partial Responses) as Defined by the International Workshop Criteria|"Complete Response (CR) - Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms.
Partial Response (PR) requires a >=50% decrease in sum of the products of the greatest dimension (SPD) of the six largest dominant nodes or nodal masses.
Overall Response Rate (ORR) - The number of patients who achieve a CR or PR divided by the total number of evaluable patients.
We report the Overall Response Rate here."|Up to 12, 28-day cycles.|||percentage of patients||95% Confidence Interval|Number
706642|NCT00110019|Secondary|Objective Response (Complete and Partial Response) Rate|Tumor response was assessed by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0. Objective response =complete response (CR) + partial response (PR). Complete response is defined as disappearance of all target lesions. Partial response is defined as at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum of longest diameters.|Tumor response was assessed after every 2 cycles during cycle 1 through 10. After cycle 10, tumor response was assessed after every 3 cycles.|Intention-to-treat population, n=823||proportion||95% Confidence Interval|Number
706643|NCT00110019|Secondary|Progression-free Survival|Progression-free survival was defined as time from study entry to disease progression or death from any cause, whichever occurred first. Patients without disease progression were censored at last date of assessment. Disease progression was assessed by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0.|Tumor response was assessed after every 2 cycles during cycle 1 through 10, and every 3 cycles after cycle 10. Survival was assessed every 3 months if patient is < 2 years from study entry, and every 6 months if 2-5 years from study entry.|Intention-to-treat population, n=821, two patients had no information about date of progression, and were excluded from the analysis||months||95% Confidence Interval|Median
706644|NCT00110019|Primary|Overall Survival|Overall survival is defined as time from study entry to death from any cause. The comparison of overall survival was conducted in intention-to-treat population.|Survival was assessed every 3 months if patient is < 2 years from study entry. Every 6 months is patient is 2-5 years from study entry.|Intention-to-treat population, n=823||months||95% Confidence Interval|Median
706645|NCT00110084|Secondary|Adverse Event|Number of patients that experienced adverse events (grade 3 or more occurring in >5% of patients) as measured by NCI CTCAE (Common Terminology Criteria for Adverse Events) v3.0|Every 6 weeks|||participants|||Number
706646|NCT00110084|Secondary|Overall Survival|Overall survival time was defined as the number of days from registration to the date of death or last follow-up|Death or last follow-up (up to 5 years)|Median survival time from Kaplan-meir estimate has not been attained.||months||95% Confidence Interval|Median
706647|NCT00110084|Secondary|Progression-free Survival|Progression-free survival was defined as the number of months from registration to the date of disease progression or death, with patients who are alive and progression free being censored on the date of their last evaluation.|Time from registration to progression or death (up to 5 years)|||months||95% Confidence Interval|Median
706648|NCT00110084|Primary|Proportion of Patients With Confirmed Responses|"Confirmed tumor response (complete and partial) as measured by RECIST(Response Evaluation Criteria In Solid Tumors) criteria on 2 consecutive evaluations at least 6 weeks apart.
Confirmed tumor response is at least a 30% decrease in the sum of the longest diameter of target lesions and no new lesions."|Two consecutive evaluations at least 6 weeks apart|per protocol||participants|||Number
706688|NCT00110396|Secondary|Number of Participants Who Were Neutralising Antibody (NAb) Positive at Anytime During the Study|The NAb positive value was defined as NAb value greater or equal to 20 NU/mL. NAbs were detected using a viral cytopathic assay.|96 weeks|ITT (One participant did not have any post-baseline NAb assessments). LOCF imputation||participants|||Number
706649|NCT00110136|Secondary|Mood is Measured by the POMS Short Form.|"POMS stands for the Profile of Mood States This is a short version of the POMS (17 questions).
Each question is scored on a 0 to 4 scale. The POMS score is the sum of the responses to the 17 questions. Responses to some questions have been reversed to make higher responses better.
The range is 0 to 68.
Higher scores represent better overall mood."|Baseline and four weeks|All registered participants.||units on a scale||Standard Deviation|Mean
706650|NCT00110136|Secondary|Effect of St. John's Wort on Quality of Life (PCS)|"Quality of life was measured by the SF12 (MCS and PCS subscales). Now we'll summarize the PCS.
SF-12 is the short form Health Survey (a short version of the SF-36) developed for the Medical Outcomes Study. It is managed by QualityMetric.
PCS is the physical health component of the SF-12. Normal population has a mean of 50 and a SD of 10. Higher scores reflect better physical health.
The range is 0 to 100.
Higher scores represent better mental health."|Baseline and four weeks|All registered participants.||units on a scale||Standard Deviation|Mean
706651|NCT00110136|Secondary|Effect of St. John's Wort on Quality of Life (MCS)|"Quality of life was measured by the SF12 (MCS and PCS subscales). First we'll summarize the MCS.
SF-12 is the short form Health Survey (a short version of the SF-36) developed for the Medical Outcomes Study. It is managed by QualityMetric.
MCS is the mental health component of the SF-12. A normal population has a mean of 50 and a SD of 10. Higher numbers represent better mental health.
The range is 0 to 100.
Higher scores represent better mental health."|Baseline and four weeks|All registered participants.||units on a scale||Standard Deviation|Mean
706652|NCT00110136|Secondary|Estimation of Toxicities While on St. John's Wort|Toxicities are quantified using the standard NCI toxicity criteria. The outcome is the percentage of participants who experience one or more toxicities. More detailed information on toxicities is found in the adverse events section.|Six weeks following baseline (four weeks of active treatment and two weeks of follow-up)|All registered participants||percentage of participants||95% Confidence Interval|Number
706653|NCT00110136|Secondary|Effect of St. John's Wort on Hot Flash Score as Recorded in a Daily Hot Flash Diary From Baseline to 4 Weeks|"The hot flash score is calculated as the frequency of hot flashes times the severity of the hot flashes averaged over a week.
Frequency is the number of hot flashes in a day. Severity is coded 0=None, 1=Mild, 2=Moderate, and 3=Severe. Score for each day is frequency times severity. Weekly score is averaged over seven days.
Score ranges from 0 to infinity
Lower scores are better."|Baseline and four weeks|All registered participants||frequency times severity||Standard Deviation|Mean
706654|NCT00110136|Primary|Effect of St. John's Wort on Hot Flash Frequency as Recorded in a Daily Hot Flash Diary From Baseline to 4 Weeks|Primary objective was to assess the change in hot flashes over a four week period in patients given St. John's Wort|Baseline and four weeks|All registered participants||number of occurrences||Standard Deviation|Mean
706655|NCT00110214|Secondary|Proportion of Participants Who Experience (Maximum) Grade 3 or Higher Toxicities|"The National Cancer Institute (NCI) Criteria for Adverse Events(CTCAE) Version 3.0 was used to evaluate toxicity. These events were considered at least possibly related to treatment.
Grade 1: mild; Grade 2: moderate; Grade 3: Severe; Grade 4: Life Threatening; Grade 5: Death"|During treatment (up to 2 years)|Participants who did not received allocated intervention were excluded from toxicity analysis.||percentage of participants|||Number
706656|NCT00110214|Secondary|Progression-free Survival (PFS)|"PFS was defined as the data of randomization to date of progression or death due to any cause, whichever occurs first. PFS was estimated using the Kaplan Meier method.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions"|Duration of study (up to 5 years)|||months||95% Confidence Interval|Median
706657|NCT00110214|Secondary|Proportion of Participants Who Experienced at Least a 50% Post-therapy PSA (Prostate-Specific Antigen) Decline|PSA decline will be reported on all patients and will be defined as a decrease in PSA value by >= 50% for two successive evaluations at least 4 weeks apart. The reference PSA value for these declines should be measured within 2 weeks before starting therapy.|Duration of study (up to 5 years)|||percentage of participants|||Number
706658|NCT00110214|Primary|Overall Survival|Overall Survival (OS) was measured from the date of randomization to date of death due to any cause. OS was estimated using the Kaplan Meier method.|Duration of study (up to 5 years)|||months||95% Confidence Interval|Median
706659|NCT00110305|Secondary|Number of Participants With Virologic Response (Viral Load Less Than 50 Copies Per mL) - as Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm, by Area Under the Plasma Concentration Time Curve From Time 0 to 24 Hours (AUC24h) Quartiles|Quartile 1, 2, 3 and 4 of AUC24h means the quartile with the lowest 25%, 26-50%, 51-75% and the highest 25% of AUC24h values, respectively, irrespective of the different doses of TMC278. For each participant, a single value for area under the plasma concentration-time curve from time of administration up to 24 hours post dosing (AUC24h) of TMC278 was estimated from a population pharmacokinetic model, based on all samples collected throughout the trial up to Week 96. Virologic response was calculated by time to loss of virologic response (TLOVR) algorithm.|Up to Week 96|Analysis included participants who received TMC278 with sufficient number of pharnacokintetic samples in order to derive population pharmacokinetic parameter. Participants who discontinued treatment for reasons other than virological failure were excluded from this analysis.||Participants|||Number
706660|NCT00110305|Secondary|Trough Plasma Concentration (Ctrough) for TMC278|For each participant, a single value for trough (i.e. predose) plasma concentration (Ctrough) of TMC278 was estimated from a population pharmacokinetic model, based on samples collected throughout the trial up to Week 96.|Up to Week 96|Analysis included participants with sufficient number of pharnacokintetic samples in order to derive population pharmacokinetic parameter.||ng/mL||Standard Deviation|Mean
706661|NCT00110305|Secondary|Area Under the Plasma Concentration Time Curve From Time 0 to 24 Hours (AUC24h) for TMC278|For each participant, a single value for area under the plasma concentration-time curve from time of administration up to 24 hours post dosing (AUC24h) of TMC278 was estimated from a population pharmacokinetic model, based on all samples collected throughout the trial up to Week 96.|Up to Week 96|Analysis included participants with sufficient number of pharmacokinetic samples in order to derive population pharmacokinetic parameter.||ng*h/mL||Standard Deviation|Mean
706732|NCT00110812|Secondary|Initiation of Continuous ART|While patients were not taking ART at baseline or while undergoing IL-2 cycles (other than use of pericycle ART in one of the three groups), some chose to start an ART regimen during the study.|from randomization through February 28, 2009|all patients randomized||participants|||Number
706662|NCT00110305|Secondary|Number of Participants With Virologic Failure for the Resistance Determinations by Developing Mutations: First Available On-Treatment Genotypic Data After Failure|Virologic failure for the resistance determinations was defined as a viral load greater than 0.5 log10 copies /mL above the nadir with a minimum of 500 copies/mL. For this study, treatment-emergent mutations (for at least one treatment) are presented as Resistance associated mutation (RAMs): i) Non-nucleotide reverse transcriptase inhibitor (NNRTI) RAMs, ii) Nucleoside/tide reverse transcriptase inhibitor (N[t]RTI RAMs).|Week 240|Intent to treat population: Participants who received at least 1 dose of study medication. This was measured at Week 240 for the combined TMC278 and Efavirenz groups, as all TMC278 participants were switched after Week 96 initially to 75 mg and subsequently to 25 mg dose.||Participants|||Number
706663|NCT00110305|Secondary|Change From Baseline in CD4+ Cell Count (Relative) at Week 240|Change from baseline in CD4+ cell count was imputed in case of missing values: in case of premature discontinuation, data were imputed with the baseline value after discontinuation (i.e. change=0, Non-Completer [NC] = Failure); otherwise last observation carried forward was applied.|Baseline (Day 1 of week 0) to Week 240|ITT population: Participants who received at least 1 dose of study medication. Efavirenz group, 1 participant was excluded due to missing baseline CD4+ cell count. This was measured at Week 240 for the combined TMC278 and Efavirenz groups, as all TMC278 participants were switched after Week 96 initially to 75 mg and subsequently to 25 mg dose.||Percentage of CD4+ cells||Standard Deviation|Mean
706664|NCT00110305|Secondary|Change From Baseline in CD4+ Cell Count (Absolute) at Week 240|Change from baseline in CD4+ cell count was imputed in case of missing values: in case of premature discontinuation, data were imputed with the baseline value after discontinuation (i.e. change=0, Non-Completer [NC] = Failure); otherwise last observation carried forward was applied.|Baseline (Day 1 of Week 0) to Week 240|ITT population: Participants who received at least 1 dose of study medication. Efavirenz group, 1 participant was excluded due to missing baseline CD4+ cell count. This was measured at Week 240 for the combined TMC278 and Efavirenz groups, as all TMC278 participants were switched after Week 96 initially to 75 mg and subsequently to 25 mg dose.||Cells per microliter||Standard Deviation|Mean
706665|NCT00110305|Secondary|Change From Baseline in CD4+ Cell Count (Relative) at Week 96|Change from baseline in CD4+ cell count was imputed in case of missing values: in case of premature discontinuation, data were imputed with the baseline value after discontinuation (i.e. change=0, Non-Completer [NC] = Failure); otherwise last observation carried forward was applied.|Baseline (Day 1 of Week 0) to Week 96|Intent to treat (ITT) population: Participants who received at least 1 dose of study medication. Efavirenz group, 1 participant was excluded due to missing baseline CD4+ cell count.||Percentage of CD4+ Cells||Standard Deviation|Mean
706666|NCT00110305|Secondary|Change From Baseline in CD4+ Cell Count (Absolute) at Week 96|Change from baseline in CD4+ cell count was imputed in case of missing values: in case of premature discontinuation, data were imputed with the baseline value after discontinuation (i.e. change=0, Non-Completer [NC] = Failure); otherwise last observation carried forward was applied.|Baseline (Day 1 of Week 0) to Week 96|Intent to treat population: Participants who received at least 1 dose of study medication.Efavirenz group, 1 participant was excluded due to missing baseline CD4+ cell count.||Cells per microliter||Standard Deviation|Mean
706667|NCT00110305|Secondary|Number of Participants With Virologic Response at Week 240 (Viral Load Less Than 400 Copies/mL) - as Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm|The TLOVR algorithm was used to derive response, ie, response and loss of response needed to be confirmed at 2 consecutive visits and participants who permanently discontinued were considered nonresponders. Participants with intermittent missing viral load values were considered responders if the preceeding and succeeding visits indicated response. In all other cases, intermittent values were imputed with nonresponse. Resuppression after confirmed virologic failure was considered as failure in this algorithm.|Week 240|Intent to treat population: Participants who received at least 1 dose of study medication. This was measured at Week 240 for the combined TMC278 and Efavirenz groups, as all TMC278 participants were switched after Week 96 initially to 75 mg and subsequently to 25 mg dose.||Participants|||Number
706668|NCT00110305|Secondary|Number of Participants With Virologic Response at Week 240 (Viral Load Less Than 50 Copies Per mL) - Snapshot Analysis|The analysis is based on the last observed viral load data within the Week 240 window. Virologic response is defined as a viral load less than 50 copies/mL. Missing viral load was considered as non-response.|Week 240|Intent to treat population: Participants who received at least 1 dose of study medication. This was measured at Week 240 for the combined TMC278 and Efavirenz groups, as all TMC278 participants were switched after Week 96 initially to 75 mg and subsequently to 25 mg dose.||Participants|||Number
706669|NCT00110305|Secondary|Number of Participants With Virologic Response at Week 240 (Viral Load Less Than 50 Copies Per mL) - as Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm|The TLOVR algorithm was used to derive response, ie, response and loss of response needed to be confirmed at 2 consecutive visits and participants who permanently discontinued were considered nonresponders. Participants with intermittent missing viral load values were considered responders if the preceeding and succeeding visits indicated response. In all other cases, intermittent values were imputed with nonresponse. Resuppression after confirmed virologic failure was considered as failure in this algorithm.|Week 240|Intent to treat population: Participants who received at least 1 dose of study medication. This was measured at Week 240 for the combined TMC278 and Efavirenz groups, as all TMC278 participants were switched after Week 96 initially to 75 mg and subsequently to 25 mg dose.||Participants|||Number
706670|NCT00110305|Secondary|Number of Participants With Virologic Response at Week 96 (Viral Load Less Than 50 Copies Per mL) - Snapshot Analysis|The analysis is based on the last observed viral load data within the Week 96 window. Virologic response is defined as a viral load less than 50 copies/mL. Missing viral load was considered as non-response.|Week 96|Intent to treat population: Participants who received at least 1 dose of study medication.||Participants|||Number
706686|NCT00110357|Secondary|Number of Participants With a Dose-Limiting Toxicity|Dose-limiting toxicities (DLTs)=serious drug side effects preventing further dose escalation. If 1 of the first 3 subjects developed a DLT during cycle 1 up to 3 additional subjects were enrolled at that dose level. The maximum dose level at which DLTs occurred in fewer than 2 out of 3 to 6 subjects was defined as the Maximum Tolerated Dose (MTD).|Prior to each 21-day cycle until dose-limiting toxicities|All treated subjects||Participants|||Number
706671|NCT00110305|Secondary|Number of Participants With Virologic Response at Week 96 (Viral Load Less Than 50 Copies Per mL) - as Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm|The TLOVR algorithm was used to derive response, ie, response and loss of response needed to be confirmed at 2 consecutive visits and participants who permanently discontinued were considered nonresponders. Participants with intermittent missing viral load values were considered responders if the preceeding and succeeding visits indicated response. In all other cases, intermittent values were imputed with nonresponse. Resuppression after confirmed virologic failure was considered as failure in this algorithm.|Week 96|Intent to treat population: Participants who received at least 1 dose of study medication.||Participants|||Number
706672|NCT00110305|Primary|Number of Participants With Virologic Response at Week 48 (Viral Load Less Than 50 Copies Per mL) - as Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm|The TLOVR algorithm was used to derive response, ie, response and loss of response needed to be confirmed at 2 consecutive visits and participants who permanently discontinued were considered nonresponders. Participants with intermittent missing viral load values were considered responders if the preceeding and succeeding visits indicated response. In all other cases, intermittent values were imputed with nonresponse. Resuppression after confirmed virologic failure was considered as failure in this algorithm.|Week 48|Intent to treat population: Participants who received at least 1 dose of study medication.||Participants|||Number
706673|NCT00110357|Secondary|Grade 3/4 Laboratory Abnormalities - Hypomagnesemia|Blood samples were collected at selected times (pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment) for clinical laboratory evaluations. Grade 3= Severe AE; Grade 4=Life-threatening or disabling AE|pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment|||Participants|||Number
706674|NCT00110357|Secondary|Grade 3-4 Laboratory Abnormalities - Thrombocytopenia|Blood samples collected at selected times (pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment) for clinical laboratory evaluations. Grade 3= Severe AE; Grade 4=Life-threatening or disabling AE|pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment|||Participants|||Number
706675|NCT00110357|Secondary|Grade 3-4 Laboratory Abnormalities - Neutropenia|Blood samples were collected at selected times (pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment) for clinical laboratory evaluations. Grade 3= Severe and undesirable AE; Grade 4=Life-threatening or disabling AE|pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment|||Participants|||Number
706676|NCT00110357|Secondary|Grade 3-4 Laboratory Abnormalities - Leukopenia|Blood samples were collected at selected times (pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment) for clinical laboratory evaluations. Grade 3= Severe AE; Grade 4=Life-threatening or disabling AE|pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment|||Participants|||Number
706677|NCT00110357|Primary|Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RPIID) of Cetuximab in Combination With Irinotecan|MTD of cetuximab intravenous (IV) weekly + irinotecan IV x5 days x2 weeks (in a 3-week cycle) and RPIID of cetuximab IV weekly, as measured by dose-limiting toxicities (see outcome measure 2)|Continuous assessment of safety throughout the entire study period and determination of doe-limiting toxicities during and at the end of Cycle 1.|As-treated population||mg/m2|||Number
706678|NCT00110357|Secondary|Number of Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs)|Toxicity assessments performed at least weekly from the 1st dose of study drug until at least 30 days after the final dose of study drug and thereafter every 4 weeks until all study-related toxicities resolved, returned to baseline, or were deemed irreversible, whichever was longer. Grade 3=severe AE; grade 4=disabling or life threatening.|Weekly throughout the study and every 4 weeks thereafter|All treated patients||Participants|||Number
706679|NCT00110357|Secondary|Human Anti-cetuximab Antibody (HACA) Response|In order to be considered positive for anti-cetuximab a sample had to: 1) be evaluable (i.e., have a pre and at least one post-treatment timepoint), 2) have an anti-cetuximab value > 7 ng/mL and 3) have a post-treatment sample at least twice the pre-treatment level.|Blood was drawn immediately prior to cetuximab infusions, on a 21-day cycle|Cohort comprises all enrolled participants who were tested for HACA. Evaluable participants had normal baseline HACA (≤ 7 ng/dL) and ≥1 postbaseline HACA levels; unevaluable participants either did not have enough sample for analysis or did not have a pre- and postinfusion sample for immunogenicity.||Participants|||Number
706680|NCT00110357|Secondary|Tumor Response|"Non-central nervous system (CNS) tumors evaluated using Response Evaluation Criteria In Solid Tumors (RECIST), criteria to define when cancer patients improve (respond), stay the same (stable), or worsen (progression). CNS tumors evaluated based on measurements by investigator, dependence on corticosteroids, and neurologic exam."|Every other 21-day cycle|All treated subjects||Participants|||Number
706681|NCT00110357|Secondary|Volume of Distribution at Steady State Corrected for Body Surface Area (VSS/BSA)|The single dose PK of cetuximab was administered with an intravenous dose of irinotecan 16 to 20 mg/m2; VSS/BSA was evaluated based on concentration-time profile.|up to 168 hours after the start of the cetuximab infusion during the first 21-day cycle of the study|||L/m2||Standard Deviation|Mean
706682|NCT00110357|Secondary|Clearance Corrected for Body Surface Area (CL/BSA)|The single dose PK of cetuximab was administered with an intravenous dose of irinotecan 16 to 20 mg/m2; CL/BSA was evaluated based on concentration-time profile.|up to 168 hours after the start of the cetuximab infusion during the first 21-day cycle of the study|||L/h/m2||Standard Deviation|Mean
706683|NCT00110357|Secondary|Terminal Half-Life (T-Half)|The single dose PK of cetuximab was administered with an intravenous dose of irinotecan 16 to 20 mg/m2; T-half was evaluated based on concentration-time profile.|up to 168 hours after the start of the cetuximab infusion during the first 21-day cycle of the study|||hours||Standard Deviation|Mean
706684|NCT00110357|Secondary|Area Under the Curve, Extrapolated to Infinity (AUC[INF])|The single dose PK of cetuximab was administered with an intravenous dose of irinotecan 16 to 20 mg/m2; AUC(INF) was evaluated based on concentration-time profile.|up to 168 hours after the start of the cetuximab infusion during the first 21-day cycle of the study|||µg•h/mL||Standard Deviation|Geometric Mean
706685|NCT00110357|Secondary|Maximum Plasma Concentration (Cmax)|The single dose pharmacokinetics (PK) of cetuximab was administered with an intravenous dose of irinotecan 16 to 20 mg/m2; Cmax was evaluated based on concentration-time profile.|up to 168 hours after the start of the cetuximab infusion during the first 21-day cycle of the study|||µg/mL||Standard Deviation|Geometric Mean
706689|NCT00110396|Primary|Number of Participants Who Were Neutralising Antibody (NAb) Positive at the Week 96 Visit.|The NAb positive value was defined as NAb value greater or equal to 20 NU/mL. NAbs were detected using a viral cytopathic assay.|96 weeks|ITT (One participant did not have any post-baseline NAb assessments). LOCF imputation||participants|||Number
706690|NCT00110461|Secondary|Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Overall Illness Score at Week 30|"Change from previous phase to Week 30 in CGI-BP severity overall illness score, using the last observation carried forward.
Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.
The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the change from the preceding phase score for mania, depression, and overall bipolar illness from 1 (very much improved) to 7 (very much worse)."|Baseline and Week 30|Since the endpoint is change from previous phase, only randomized subjects who had both previous phase and at least one next phase were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.||points||Standard Deviation|Mean
706691|NCT00110461|Secondary|Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Overall Illness Score at Week 4|"Change from previous phase to Week 4 in CGI-BP severity overall illness score, using the last observation carried forward.
Assessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.)
The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the change from the preceding phase score for mania, depression, and overall bipolar illness from 1 (very much improved) to 7 (very much worse)."|Baseline and Week 4|Since the endpoint is change from previous phase, only randomized subjects who had both previous phase and at least one next phase were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.||points||Standard Deviation|Mean
706692|NCT00110461|Secondary|Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Depression Score at Week 30|"Change from previous phase to Week 30 in CGI-BP severity depression score, using the last observation carried forward.
Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.
The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the change from the preceding phase score for mania, depression, and overall bipolar illness from 1 (very much improved) to 7 (very much worse)."|Baseline and Week 30|Since the endpoint is change from previous week, only randomized subjects who had both previous week and at least next week were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.||points||Standard Deviation|Mean
706693|NCT00110461|Secondary|Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Depression Score at Week 4|"Change from previous phase to Week 4 in CGI-BP severity depression score, using the last observation carried forward.
Assessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.)
The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the change from the preceding phase score for mania, depression, and overall bipolar illness from 1 (very much improved) to 7 (very much worse)."|Baseline and Week 4|Since the endpoint is change from previous phase, only randomized subjects who had both previous phase and at least one next phase were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.||points||Standard Deviation|Mean
706694|NCT00110461|Secondary|Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Mania Score at Week 30|"Change from previous phase to Week 30 in CGI-BP mania score, using the last observation carried forward.
Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.
The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the change from the preceding phase score for mania, depression, and overall bipolar illness from 1 (very much improved) to 7 (very much worse)."|Baseline and Week 30|Since the endpoint is change from previous phase, only randomized subjects who had both previous phase and at least one next phase were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.||points||Standard Deviation|Mean
706695|NCT00110461|Secondary|Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Mania Score at Week 4|"Change from previous phase to Week 4 in CGI-BP mania score, using the last observation carried forward.
Assessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.)
The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the change from the preceding phase score for mania, depression, and overall bipolar illness from 1 (very much improved) to 7 (very much worse)."|Baseline and Week 4|Since the endpoint is change from previous phase, only randomized subjects who had both previous phase and at least one next phase were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.||points||Standard Deviation|Mean
706696|NCT00110461|Secondary|Subject Response to Treatment at Week 30|"Percentage of Subjects with a 50% or higher reduction from baseline in Y-MRS total score at Week 30.
Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.
The Y-MRS consists of 11 items assessing the core symptoms of mania. Each item has 5 grades of severity. Minimum score on the scale is 0 (absent or normal). Maximum score on the scale is 60 (worse outcome or more severe symptoms)."|Baseline and Week 30|Since the primary efficacy endpoint is change from baseline in Y-MRS total score, only randomized subjects who had both baseline and at least one post-baseline were included in the primary efficacy analysis. Therefore, number of randomized subjects could be different number subjects included in the efficacy analysis.||percentage of participants|||Number
706733|NCT00110812|Secondary|Disease Progression or Death|occurrence of an opportunistic event (AIDS-defining infection or malignancy) or death|throughout study, through Feb 28 2009 (median followup of 19 months)|all randomized patients||participants|||Number
706697|NCT00110461|Secondary|Subject Response to Treatment at Week 4|"Percentage of Subjects with a 50% or higher reduction from baseline in Young Mania Rating Scale (Y-MRS) total score at Week 4.
Assessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.)
The Y-MRS consists of 11 items assessing the core symptoms of mania. Each item has 5 grades of severity. Minimum score on the scale is 0 (absent or normal). Maximum score on the scale is 60 (worse outcome or more severe symptoms)."|Baseline and Week 4|Since the primary efficacy endpoint is change from baseline in Y-MRS total score, only randomized subjects who had both baseline and at least one post-baseline were included in the primary efficacy analysis. Therefore, number of randomized subjects could be different number subjects included in the efficacy analysis.||percentage of participants|||Number
706698|NCT00110461|Secondary|Change in Attention Deficit Hyperactivity Disorders Rating Scale (ADHD-RS-IV) Total Score at Week 30|"Change from baseline to Week 30 in ADHD-RS-IV Total score, using the LOCF.
Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.
The ADHD-RS-IV is an instrument both for diagnosing ADHD in children and adolescents and for assessing treatment response. The scale contains 18 items and is linked directly to DSM-IV diagnostic criteria for ADHD. The parent questionnaire on home behaviors (English) was used in this study. Minimum score of 0 = better outcome, maximum score of 54 = worse outcome."|Baseline and Week 30|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.||points||Standard Deviation|Mean
706699|NCT00110461|Secondary|Change in General Behavior Inventory Scale (GBI) Total Subject Version Depression Score at Week 30|Change from baseline to Week 30 in GBI Total Subject Version Depression score, using LOCF. Assessments performed at baseline and weekly through the acute phase (Week 4); also at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. GBI is a self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale completed by the subject. Symptoms rated on a 4-point Likert scale from 0 (never or hardly ever) to 3 (often or almost constantly). Minimum score 0=better outcome, maximum score 60=worse outcome.|Baseline and Week 30|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.||points||Standard Deviation|Mean
706700|NCT00110461|Secondary|Change in General Behavior Inventory Scale (GBI) Total Subject Version Depression Score at Week 4|Change from Baseline to Week 4 in GBI Total Subject Version Depression score, using LOCF. Assessments performed at baseline and weekly through the acute phase (Week 4); also at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. GBI is a self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale was completed by subject. Symptoms wrated on a 4-point Likert scale from 0 (never or hardly ever) to 3 (often or almost constantly). Minimum score 0=better outcome, maximum score 60=worse outcome.|Baseline and Week 4|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.||points||Standard Deviation|Mean
706701|NCT00110461|Secondary|Change in General Behavior Inventory Scale (GBI) Total Parent/Guardian Version Depression Score at Week 30|Change from Baseline to Week 30 in GBI Total Parent/Guardian Version Depression score, using LOCF. Assessments performed at baseline and weekly through the acute phase (Week 4); also Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. GBI is a self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale completed by parent/guardian. Symptoms rated on 4-point Likert scale from 0 (never/hardly ever) to 3 (often/almost constantly). Minimum score 0=better outcome, maximum score 60=worse outcome.|Baseline and Week 30|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.||points||Standard Deviation|Mean
706702|NCT00110461|Secondary|Change in General Behavior Inventory Scale (GBI) Total Parent/Guardian Version Depression Score at Week 4|Change from baseline to Week 4 in GBI Total Parent/Guardian Version Depression score, using LOCF. Assessments performed at baseline and weekly through the acute phase (Week 4); also Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. GBI is a self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale was completed by parent/guardian. Symptoms rated on 4-point Likert scale from 0 (never/hardly ever) to 3 (often/almost constantly). Minimum score 0=better outcome, maximum score 60=worse outcome.|Baseline and Week 4|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.||points||Standard Deviation|Mean
706703|NCT00110461|Secondary|Change in General Behavior Inventory Scale (GBI) Total Subject Version Mania Score at Week 30|Change from baseline to Week 30 in GBI Total Subject Version Mania score, using LOCF. Assessments performed at baseline and weekly through acute phase (Week 4) and Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. GBI is a self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale completed by the subject. Symptoms rated on a 4-point Likert scale from 0 (never or hardly ever) to 3 (often or almost constantly). Minimum score of 0=better outcome, maximum score of 60=worse outcome.|Baseline and Week 30|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.||points||Standard Deviation|Mean
706734|NCT00110812|Secondary|Fasting Lipid Profile|total fasting cholesterol|week 32|all patients with laboratory data at week 32 who reported fasting||mg/dl||Standard Deviation|Mean
706808|NCT00116831|Secondary|Percent Change From Baseline to Month 18 in Apoprotein B (apoB)|Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.|Baseline to Month 18|ITT Population without LOCF||percent change|||Number
706704|NCT00110461|Secondary|Change in General Behavior Inventory Scale (GBI) Total Subject Version Mania Score at Week 4|Change from baseline to Week 4 in GBI Total Subject Version Mania score, using the LOCF. Assessments performed at baseline and weekly through acute phase (Week 4). (Also performed Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.) GBI is a self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale completed by the subject. Symptoms rated on a 4-point Likert scale from 0 (never or hardly ever) to 3 (often or almost constantly). Minimum score 0=better outcome, maximum score 60=worse outcome.|Baseline and Week 4|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.||points||Standard Deviation|Mean
706705|NCT00110461|Secondary|Change in General Behavior Inventory Scale (GBI) Total Parent/Guardian Version Mania Score at Week 30|Change from baseline to Week 30 in GBI Total Parent/Guardian Version Mania score, using LOCF. Assessments performed at baseline and weekly through acute phase(Week 4) and Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. GBI is a self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale was completed by parent/guardian. Symptoms rated on a 4-point Likert scale from 0 (never or hardly ever) to 3 (often or almost constantly). Minimum score 0=better outcome, maximum score 60=worse outcome.|Baseline and Week 30|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.||points||Standard Deviation|Mean
706706|NCT00110461|Secondary|Change in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 30|Change from baseline to Week 30 in CDRS-R score, using the last observation carried forward. Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. The CDRS-R is used to diagnose depression and monitor treatment response. The interviewer rates 17 symptom areas (including those that sever as DSM-IV criteria for diagnosis of depression), among them suicidal ideation. Minimum score on the scale is 17 (better outcome). Maximum score on the scale is 113 (worse outcome or more severe symptoms).|Baseline and Week 30|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.||points||Standard Deviation|Mean
706707|NCT00110461|Secondary|Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Overall Illness Score at Week 30|"Change from baseline to Week 30 in CGI-BP severity overall illness score, using the last observation carried forward.
Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.
The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the subject’s severity of illness for mania, depression, and overall bipolar illness from 1 (least severe) to 7 (most severe)."|Baseline and Week 30|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.||points||Standard Deviation|Mean
706708|NCT00110461|Secondary|Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Overall Illness Score at Week 4|"Change from baseline to Week 4 in CGI-BP severity overall illness score, using the last observation carried forward.
Assessments performed at baseline and weekly through the acute phase (Week 4). (Also performed and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.)
The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the subject’s severity of illness for mania, depression, and overall bipolar illness from 1 (least severe) to 7 (most severe)."|Baseline and Week 4|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.||points||Standard Deviation|Mean
706709|NCT00110461|Secondary|Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Depression Score at Week 30|"Change from baseline to Week 30 in CGI-BP severity depression score, using the last observation carried forward.
Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.
The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the subject’s severity of illness for mania, depression, and overall bipolar illness from 1 (least severe) to 7 (most severe)."|Baseline and Week 30|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.||points||Standard Deviation|Mean
706710|NCT00110461|Secondary|Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Depression Score at Week 4|"Change from baseline to Week 4 in CGI-BP severity depression score, using the last observation carried forward.
Assessments performed at baseline and weekly through the acute phase (Week 4. (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.)
The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the subject’s severity of illness for mania, depression, and overall bipolar illness from 1 (least severe) to 7 (most severe)."|Baseline and Week 4|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.||points||Standard Deviation|Mean
706735|NCT00110812|Secondary|HIV-1 Genotype Changes|Patients who developed mutations associated with antiretroviral drugs.|after 3rd cycle of IL-2|Per protocol, the analysis of genotypic changes associated with antiretroviral resistance was restricted patients in one arm, namely, patients assigned to take pericycle HAART who completed 3 cycles of IL-2 and who had successful genotypes.||participants|||Number
706736|NCT00110812|Secondary|Change in CD4 T Lymphocyte Count|change from baseline to month 12 in CD4 T lymphocyte count|At Month 12|patients for whom the month 12 CD4 count was available||cell/mm^3||Standard Deviation|Mean
706711|NCT00110461|Secondary|Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Mania Score at Week 30|"Change from baseline to Week 30 in CGI-BP mania score, using the last observation carried forward.
Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.
The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the subject’s severity of illness for mania, depression, and overall bipolar illness from 1 (least severe) to 7 (most severe)."|Baseline and Week 30|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.||points||Standard Deviation|Mean
706712|NCT00110461|Secondary|Change in Children's Global Assessment (CGAS) Total Score at Week 30|"Change from baseline to Week 30 in CGAS total score, using the last observation carried forward.
Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.
The CGAS is a 100-point scale measuring psychological, social, and school functioning for children aged 6 to 17 years. Minimum scores ranged from 1-10, representing the need for constant supervision (worse outcome) to maximum scores of 91-100, representing superior functioning (better outcome)."|Baseline and Week 30|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.||points||Standard Deviation|Mean
706713|NCT00110461|Secondary|Change in Attention Deficit Hyperactivity Disorders Rating Scale (ADHD-RS-IV) Total Score at Week 4|Change from baseline to Week 4 in ADHD-RS-IV Total score, using last observation carried forward. Assessments performed at baseline and weekly through acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.) ADHD-RS-IV is an instrument for diagnosing ADHD in children/adolescents and for assessing treatment response. The scale contains 18 items linked directly to DSM-IV diagnostic criteria for ADHD. Parent questionnaire on home behaviors (Eng.) used in this study. Minimum score of 0 is a better outcome, maximum score of 54 is a worse outcome.|Baseline and Week 4|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.||points||Standard Deviation|Mean
706714|NCT00110461|Secondary|Change in General Behavior Inventory Scale (GBI) Total Parent/Guardian Version Mania Score at Week 4|Change from baseline to Week 4 in GBI Total Parent/Guardian Version Mania score, using LOCF. Assessments performed baseline and weekly through acute phase (Week 4). (Also at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.) GBI is self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale was completed by parent/guardian. Symptoms rated on a 4-point Likert scale from 0 (never or hardly ever) to 3 (often or almost constantly). Minimum score 0=better outcome, maximum score 60=worse outcome.|Baseline and Week 4|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.||points||Standard Deviation|Mean
706715|NCT00110461|Secondary|Change in Children’s Depression Rating Scale-Revised (CDRS-R) Total Score at Week 4|Change from baseline to Week 4 in CDRS-R score, using last observation carried forward. Assessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.) The CDRS-R is used to diagnose depression and monitor treatment response. The interviewer rates 17 symptom areas (including those that sever as DSM-IV criteria for diagnosis of depression), among them suicidal ideation. Minimum score on the scale is 17 (better outcome). Maximum score on the scale is 113 (worse outcome or more severe symptoms).|Baseline and Week 4|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.||points||Standard Deviation|Mean
706716|NCT00110461|Secondary|Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Mania Score at Week 4|"Change from baseline to Week 4 in CGI-BP mania score, using the last observation carried forward.
Assessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.)
The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the subject’s severity of illness for mania, depression, and overall bipolar illness from 1 (least severe) to 7 (most severe)."|Baseline and Week 4|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.||points||Standard Deviation|Mean
706717|NCT00110461|Secondary|Change in Children’s Global Assessment Scale (CGAS) Total Score at Week 4|"Change from baseline to Week 4 in CGAS total score, using the last observation carried forward. Assessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.)
The CGAS is a 100-point scale measuring psychological, social, and school functioning for children aged 6 to 17 years. Minimum scores ranged from 1-10, representing the need for constant supervision (worse outcome) to maximum scores of 91-100, representing superior functioning (better outcome)."|Baseline and Week 4|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.||points||Standard Deviation|Mean
706737|NCT00110812|Secondary|Plasma HIV RNA|change from baseline in HIV-RNA copies/ml (log10)|At Week 32|Patients for whom HIV-RNA was available at week 32||copies/ml (log 10)||Standard Deviation|Mean
706738|NCT00110812|Secondary|Discontinuation of IL-2|Patients receiving fewer than 3 cycles of IL-2 by week 32|week 32|all patients randomized to a study arm containing IL-2||participants|||Number
706739|NCT00110812|Primary|Mean Change in CD4+ T Lymphocyte Count|Change in CD4 count from baseline to week 32.|Week 32|patients for whom the week-32 CD4+ cell count was measured||cell/mm^3||Standard Deviation|Mean
706718|NCT00110461|Secondary|Change in Young Mania Rating Scale (Y-MRS) Total Score at Week 30|"Change from baseline to Week 30 in Y-MRS total score, using the last observation carried forward.
Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.
The Y-MRS consists of 11 items assessing the core symptoms of mania. Each item has 5 grades of severity. Minimum score on the scale is 0 (absent or normal). Maximum score on the scale is 60 (worse outcome or more severe symptoms)."|Baseline and Week 30|Since the endpoint is change from baseline in Y-MRS total score, only randomized subjects who had both baseline and at least one post-baseline were included in the primary efficacy analysis. Therefore, number of randomized subjects could be different number subjects included in the efficacy analysis.||points||Standard Deviation|Mean
706719|NCT00110461|Primary|Change in Young Mania Rating Scale (Y-MRS) Total Score at Week 4|"Change from Baseline to Week 4 in Y-MRS total score, using the last observation carried forward.
Assessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through the continuation phase.)
The Y-MRS consists of 11 items assessing the core symptoms of mania. Each item has 5 grades of severity. Minimum score on the scale is 0 (absent or normal). Maximum score on the scale is 60 (worse outcome or more severe symptoms)."|Baseline and Week 4|Since the primary efficacy endpoint is change from baseline in Y-MRS total score, only randomized subjects who had both baseline and at least one post-baseline were included in the primary efficacy analysis. Therefore, number of randomized subjects be different number subjects included in the efficacy analysis.||points||Standard Deviation|Mean
706720|NCT00110513|Primary|Incidence of Thromboembolic Events Acute Deep Venous Thrombosis (DVT) and/or Thromboembolic Events Other Than Acute Deep Venous Thrombosis (DVT)|To assess the incidence of thromboembolic events acute deep venous thrombosis (DVT) and/or thromboembolic events other than acute deep venous thrombosis (DVT) by clinical signs and symptoms of venous thromboembolism (VTE), confirmed by diagnostic assessments.|During treatment and follow up period of 7 days|Intent to treat population||Participants|||Number
706721|NCT00110617|Secondary|Absolute Change in Serum Ferritin After Start of Treatment With Deferasirox (ICL670) to Week 104|Absolute change in serum ferritin after start of treatment with Deferasirox (ICL670) to week 104 for the Deferasirox treatment group. Means were adjusted for the amount of transfused blood.|Start of Deferasirox (ICL670) treatment, 104 Weeks|Per Protocol- 2 set defined as all participants who received study drug and had assessment of serum ferritin at Start of ICL670 treatment and at 104 weeks.||mg/mL||95% Confidence Interval|Least Squares Mean
706722|NCT00110617|Primary|The Number of Participants With Adverse Events (AEs) in the First 24 Weeks of Treatment|The number of participants with Adverse Events (AEs) overall and according to Medical Dictionary for Regulatory Activities (MedDRA) preferred term greater than or equal to 5% participants in any group by treatment in the first 24 weeks.|24 Weeks|Safety-1 set: All participants, except participants enrolled in Center 512, who received at least one dose of study medication during the first 24 weeks.||participants|||Number
706723|NCT00110617|Secondary|Absolute Change in Serum Ferritin After Start of Treatment With Deferasirox (ICL670) to Week 24 and to Week 52|Absolute change in serum ferritin after start of treatment with Deferasirox (ICL670) to week 24 and the absolute change in serum ferritin after start of treatment with Deferasirox (ICL670) to week 52 for the Deferasirox treatment group and the Deferoxamine then Deferasirox treatment group. Means were adjusted for the amount of transfused blood.|Start of Deferasirox (ICL670) treatment, 24 Weeks, 52 Weeks|Per Protocol- 2 set defined as all participants who received study drug and had an assessment of serum ferritin at Start of ICL670 treatment and at 24 weeks or 52 weeks.||mg/mL||95% Confidence Interval|Least Squares Mean
706724|NCT00110617|Secondary|Absolute Change in Serum Ferritin From Baseline to Week 24|Absolute change from baseline serum ferritin after 24 weeks of treatment with Deferasirox (ICL670) and absolute change from baseline serum ferritin after 24 weeks of treatment with Deferoxamine. Means were adjusted for the amount of transfused blood.|Baseline, 24 Weeks|Per protocol- 1 defined as all participants who had study drug and had an assessment of serum ferritin at Baseline and at Week 24.||mg/mL||95% Confidence Interval|Least Squares Mean
706725|NCT00110812|Post-Hoc|Commencement of Continuous Antiretroviral Treatment|Number of patients commencing continuous antiretroviral treatment.|from randomization through February 28, 2011, the end of the extension phase|All randomized patients are counted. Patients who did not consent to the extension phase are censored at the end of the main study (Feb 28, 2009). Because the focus of the extension was on the safety of patients exposed to IL-2, the outcomes were summarized for the two groups exposed to IL-2 vs. the group that did not take IL-2.||participants|||Number
706726|NCT00110812|Post-Hoc|Undetectable HIV-RNA|Patients with undetectable HIV-RNA levels measured at 24 months after the close of the main study, at the end of the extension phase.|24 months post-trial|All patients for whom an HIV-RNA measurement was available during the extension phase. Because the focus of the extension was on the safety of patients exposed to IL-2, the outcomes were summarized for the two groups exposed to IL-2 vs. the group that did not take IL-2.||participants|||Number
706727|NCT00110812|Post-Hoc|CD4+ Cell Count 2 Years Post-study||two years following close of main study|All patients for whom a CD4 count measurement was available during the extension phase. Because the focus of the extension was on the safety of patients exposed to IL-2, the outcomes were summarized for the two groups exposed to IL-2 vs. the group that did not take IL-2.||cell/mm^3||Standard Deviation|Mean
706728|NCT00110812|Post-Hoc|Opportunistic Disease or Death During the Trial Extension Phase|Incidence of an opportunistic event (AIDS-defining infection or malignancy) or death between February 28, 2009, when the main study ended, and February 28, 2011, when the extended phase was completed.|two years following close of main study|All patients who were alive at the end of the main study and who consented to be followed for an additional 2 years in the extension phase. Because the focus of the extension was on the safety of patients exposed to IL-2, the outcomes were summarized for the two groups exposed to IL-2 vs. the group that did not take IL-2.||participants|||Number
706729|NCT00110812|Secondary|SGOT|Number of participants with aspartate aminotransferase (SGOT) greater than 5 times the upper limit of normal|week 32|all patients with SGOT measured at week 32||participants|||Number
706730|NCT00110812|Secondary|Thyroid Stimulating Hormone|Number of participants with thyroid stimulating hormone greater than the upper limit of normal|week 32|all patients with TSH measured at 32 weeks||participants|||Number
706731|NCT00110812|Secondary|Change in HIV-RNA Copies/ml (log10) From Baseline to Month 12||month 12|patients for whom HIV-RNA measurement was available at baseline and month 12.||copies/ml (log 10)||Standard Deviation|Mean
706740|NCT00116649|Secondary|Percent Reduction From Baseline to the Final Follow-up in Total Actinic Keratosis Lesion Count|Percent reduction = (total baseline AK lesion count - total final lesion count)x100/ total baseline AK lesion count|At Month 18|The ITT population (n=526) consisted of the Safety population who had at least one scheduled primary efficacy assessment at a post-baseline visit||percent reduction||Standard Deviation|Mean
706741|NCT00116649|Primary|Number of Participants Who Experienced an Adverse Event|Adverse events that occurred between the first day of exposure to the study cream and study discharge were summarized. Adverse events - any untoward medical occurrence in a subject that is temporally related to protocol procedures, including the administration of a pharmaceutical product at any dose, but which does not necessarily have a causal relationship with the treatment.|from first dose up to 18 months|There were 551 subjects in the Safety population, which consisted of the enrolled subjects who received at least one dose of study medication.||participants|||Number
706742|NCT00116688|Secondary|Patient Global Assessment|The Patient Global Assessment is two questions which assess the overall health-related quality of life (HRQOL) and symptoms of the patient. Each item is answered on a 15-point Likert scale ranging from 'A very great deal worse' (1) to 'A very great deal better' (15). A higher score indicates that quality of life or symptoms have improved.|Week 1 and Week 48|Full analysis set with available data. Patient reported outcomes were only analyzed in adult participants.||scores on a scale||Standard Deviation|Mean
706743|NCT00116688|Secondary|Change From Baseline in Euroqol-5D (EQ-5D) Visual Analogue Scale (VAS)|The EQ-5D is a patient-completed, multidimensional measure of health related quality of life. The EQ-5D VAS records the respondent’s self-rated health status on a vertical graduated (0-100) visual analogue scale. Higher EQ-5D VAS scores represent better health status.|Baseline to Week 48|Full analysis set with available data. Patient reported outcomes were only analyzed in adult participants.||scores on a scale||Standard Deviation|Mean
706744|NCT00116688|Secondary|Change From Baseline in Euroqol-5D (EQ-5D) Index Score|The EQ-5D is a patient-completed, multidimensional measure of health related quality of life. The instrument is applicable to a wide range of health conditions and treatments and results in a single index score and a visual analog scale (VAS) score. The EQ-5D descriptive health profile comprises five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension comprises three levels (no problems, some/moderate problems, extreme problems). A unique EQ-5D health state is defined by combining one level from each of the five dimensions. EQ-5D index values range from -0.59 to 1.00. Higher EQ-5D Index scores represent better health status.|Baseline to Week 48|Full analysis set with available data. Patient reported outcomes were only analyzed in adult participants.||scores on a scale||Standard Deviation|Mean
706745|NCT00116688|Secondary|Change From Baseline in Short Form 36 (SF-36)|The SF-36 is a widely used generic health-related quality of life measure. It has 36 questions with 8 domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health. Items are scored from 0 to 100 with higher scores indicating better health status.|Baseline to Week 48|Full analysis set with available data. Patient reported outcomes were only analyzed in adult participants.||scores on a scale||Standard Deviation|Mean
706746|NCT00116688|Secondary|Change From Baseline in ITP Patient Assessment Questionnaire|The ITP Patient Assessment Questionnaire (ITP-PAQ) assesses ITP-specific health-related quality of life (HRQOL). This questionnaire assesses ITP specific health-related quality of life (HRQOL). The questionnaire consists of 44 items and has six domains: These domains assess the impact of ITP on Physical Health, Mental Health, Work, Social Activity, Women’s Health and Overall QOL. The impact of ITP on Physical Health consists of four sub-scales, which evaluate ITP related Symptoms, Fatigue, Bother and Activity. The impact of ITP on Mental Health consists of two sub-scales, which evaluate Psychological distress and Fear in a population with ITP. Items are scored from 0-100 with higher scores indicating better HRQOL.|Baseline to Week 48|Full analysis set with available data. Patient reported outcomes were only analyzed in adult participants.||scores on a scale||Standard Deviation|Mean
706747|NCT00116688|Secondary|Number of Participants With a Reduction or Discontinuation of Concurrent ITP Therapies|The number of participants with a reduction or discontinuation of concurrent immune (idiopathic) thrombocytopenic purpura (ITP) therapies (corticosteroids, danazol, azathioprine) during the study.|Duration of treatment (up to 277 weeks)|Subset of Efficacy Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim and with baseline concurrent ITP therapy.||Participants|||Number
706748|NCT00116688|Secondary|Number of Participants With a Platelet Response|Platelet response was defined as having a platelet count of ≥ 50 x 10^9/L at any time on study, excluding platelet counts within 8 weeks after receiving any rescue medications.|Duration of treatment (up to 277 weeks)|Efficacy Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim||Participants|||Number
706749|NCT00116688|Primary|Number of Participants With Adverse Events|Participants with one or more occurrences of one or more adverse events up to 8 weeks after the end of treatment. Participants with more than one event were only counted once.|Duration of treatment plus 8 weeks (up to 285 weeks)|Safety Analysis Set, composed of all participants who received at least one dose of romiplostim||Participants|||Number
706750|NCT00116753|Secondary|Number of Participants With Markedly Abnormal Change in Vital Signs and Body Weight as Compared to Baseline|This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value.|12 or 13 months|ITT population.||participants|||Number
706751|NCT00116753|Secondary|Liver Function Tests|The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases >3x ULN and ALT increases >3x ULN with concurrently increased bilirubin >1.5 ULN.|12 or 13 months|ITT population.||participants|||Number
706752|NCT00116753|Secondary|Number of Participants With Testosterone <=0.5 ng/mL at Day 28|Figures in the table give number of participants with testosterone <=0.5 ng/mL 28 days after the initial dose of trial medication.|28 Days|Observed Cases in ITT population.||participants|||Number
706809|NCT00116831|Secondary|Percent Change From Baseline to Month 18 in Free Fatty Acids (FFA)|Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.|Baseline to Month 18|ITT Population without LOCF||percent change|||Number
706753|NCT00116753|Secondary|Number of Participants With Testosterone Level <=0.5 ng/mL After the Dose at Day 28 Until the End of the Study|Figures in the table give the number of participants with all testosterone values <=0.5 ng/mL after the dose at Day 28 to end of study. Thus, the testosterone response after the initial dose is not included in this outcome measure.|From after Day 28 to 12 or 13 months|Observed Cases in ITT population.||participants|||Number
706754|NCT00116753|Primary|Number of Participants With Testosterone Level <=0.5 ng/mL From Day 28 Until the End of the Study|Figure in the table give the number of participants with all testosterone values <=0.5 ng/mL from Day 28 to the end of the study.|From Day 28 to 12 or 13 months|Observed Cases in ITT population.||participants|||Number
706755|NCT00116779|Secondary|Participants With Markedly Abnormal Changes in Vital Signs or Body Weight|Vital sign and body weight values at the end of the trial are compared to baseline values. The table represents the number of participants in each group with normal baseline values and markedly abnormal end-of-study values.|Day 364|ITT population. Diastolic blood pressure n=63,63 Pulse n=63,60 Systolic blood pressure n=63,64 Weight n=55,61||participants|||Number
706756|NCT00116779|Secondary|Number of Participants With Abnormal Total Bilirubin Values|Participants with abnormal total bilirubin values|Day 1 - 364|ITT population||participants|||Number
706757|NCT00116779|Secondary|Number of Participants With Abnormal Aspartate Aminotransferase Values|Participants with aspartate aminotransferase values that were above the normal range.|Day 1 - 364|ITT population||participants|||Number
706758|NCT00116779|Secondary|Number of Participants With Abnormal Alanine Aminotransferase Values|Participants whose alanine aminotransferase values were at levels above the normal range.|Day 1 through day 364|ITT population||participants|||Number
706759|NCT00116779|Secondary|Median Testosterone Levels at Various Days During the Study|Testosterone levels at baseline and days 1, 3, 7, 14 and 364|Baseline, Days 1,3,7,14,364|ITT population||nanograms / milliliter||Full Range|Median
706760|NCT00116779|Secondary|Median Luteinizing Hormone Levels at Various Study Timeframes|Luteinizing hormone levels at baseline, and days 1, 3, 7, and 14.|Baseline, Days 1, 3, 7, 14|ITT population||international units / liter||Full Range|Median
706761|NCT00116779|Secondary|Median Prostate-Specific Antigen Values at Various Study Timepoints|Prostate-specific antigen levels at baseline and days 3, 14, 28, 84, and 364.|Baseline, Days 3, 14, 28, 84, 364|ITT population||nanogram / milliliter||Full Range|Median
706762|NCT00116779|Secondary|Median Di-Hydrotestosterone Levels At Various Study Timepoints|Di-hydrotestosterone levels at baseline and days 1, 3, 7, 14|Baseline, Days 1, 3, 7, 14|ITT population||picogram / milliliter||Full Range|Median
706763|NCT00116779|Secondary|Days to Prostate-Specific Antigen Progression|Median days to prostate-specific antigen increase of >= 50 percent and >= 5 nanograms/milliliter compared to nadir on two consecutive visits at least 2 weeks apart.|Day 0 (post dose) to Day 364|ITT population. 5 patients in the 60 mg group and 4 patients in the 80 mg group had PSA progression.||days||Full Range|Median
706764|NCT00116779|Secondary|Days to 50 Percent and 90 Percent Reduction in Prostate-Specific Antigen|Median number of days after the first dose of Degarelix when the Prostate-Specific Antigen levels fell to 50 percent and 90 percent of the baseline value.|Day 0 (post dose) to Day 364|ITT population||days||Full Range|Median
706765|NCT00116779|Primary|Number of Participants With Testosterone Level <= 0.5 Nanogram/Milliliter From Day 28 to Day 364 for Participants With Testosterone <= 0.5 Nanogram/Milliliter at Day 28|Number of participants who maintained a testosterone level of <=0.5 nanogram/milliliter from Day 28 to Day 364.|Day 28 - Day 364|ITT population of participants who completed the study and had a testosterone level of <=0.5 nanogram per milliliter at Day 28.||participants|||Number
706766|NCT00116779|Secondary|Number of Participants With Testosterone <= 0.5 Nanogram/Milliliter at Day 3.|Testosterone levels checked at Day 3 to determine if the reduction in testosterone level occurs rapidly after dosing.|Day 3|ITT population||participants|||Number
706767|NCT00116779|Primary|Number of Participants With Testosterone <=0.5 Nanogram/Milliliter From Day 28 to Day 364|Number of participants with all testosterone values <=0.5 nanogram/milliliter from Day 28 to Day 364|Day 28 to Day 364|ITT population of patients who completed the study and had testosterone <=0.5 nanogram per milliliter at Day 28.||participants|||Number
706768|NCT00116805|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 480 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 480 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 432 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 432 and had HBV DNA ≥ 400 copies/mL at the time of the addition.|Baseline; Weeks 433 to 480|Participants in the Randomized and Treated Analysis Set who continued on the study after Week 432 with available data were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.||participants|||Number
706769|NCT00116805|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 432 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 432 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 384 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 384 and had HBV DNA ≥ 400 copies/mL at the time of the addition.|Baseline; Weeks 385 to 432|Participants in the Randomized and Treated Analysis Set who continued on the study after Week 384 with available data were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.||participants|||Number
706770|NCT00116805|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 384 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 384 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 336 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 336 and had HBV DNA ≥ 400 copies/mL at the time of the addition.|Baseline; Weeks 337 to 384|Participants in the Randomized and Treated Analysis Set who continued on the study after Week 336 with available data were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.||participants|||Number
710939|NCT00168844|Secondary|Change From Baseline in Neutrophils|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||percentage of white blood cell count||Standard Deviation|Mean
706771|NCT00116805|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 336 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 336 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 288 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 288 and had HBV DNA ≥ 400 copies/mL at the time of the addition.|Baseline; Weeks 289 to 336|Participants in the Randomized and Treated Analysis Set who continued on the study after Week 288 with available data were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.||participants|||Number
706772|NCT00116805|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 288 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 288 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 240 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 240 and had HBV DNA ≥ 400 copies/mL at the time of the addition.|Baseline; Weeks 241 to 288|Participants in the Randomized and Treated Analysis Set who continued on the study after Week 240 with available data were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.||participants|||Number
706773|NCT00116805|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 240 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 240 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 192 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 192 and had HBV DNA ≥ 400 copies/mL at the time of the addition.|Baseline; Weeks 193 to 240|Participants in the Randomized and Treated Analysis Set who continued on the study after Week 192 with available data were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.||participants|||Number
706774|NCT00116805|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 192 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 192 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 144 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 144 and had HBV DNA ≥ 400 copies/mL at the time of the addition.|Baseline; Weeks 145 to 192|Participants in the Randomized and Treated Analysis Set who continued on the study after Week 144 with available data were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.||participants|||Number
706775|NCT00116805|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 144 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 144 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 96 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 96 and had HBV DNA ≥ 400 copies/mL at the time of the addition.|Baseline; Weeks 97 to 144|Participants in the Randomized and Treated Analysis Set who continued on the study after Week 96 with available data were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.||participants|||Number
706776|NCT00116805|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 96 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 96 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 48 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen and had HBV DNA ≥ 400 copies/mL at the time of the addition.|Baseline; Weeks 49 to 96|Participants in the Randomized and Treated Analysis Set who continued on the study after Week 48 (ie, entered the open-label phase) were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.||participants|||Number
706777|NCT00116805|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 48 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL, those with viral breakthrough, and those who discontinued after Week 24 with HBV DNA ≥ 400 copies/mL.|Baseline; Week 48|Participants in the Randomized and Treated Analysis Set were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.||participants|||Number
706778|NCT00116805|Secondary|Percentage of Participants With HBsAg Loss or Seroconversion to Anti-HBs at Weeks 144, 192, 240, 288, 336, 384, 432, and 480|HBsAg loss was defined as HBsAg positive at baseline and HBsAg negative at the subsequent time point. Seroconversion to anti-HBs was defined as change of detectable antibody to HBsAg from negative at baseline to positive at the subsequent time point.|Baseline; Weeks 144, 192, 240, 288, 336, 384, 432, and 480|Randomized and Treated Analysis Set. Data is included for participants who had discontinued unless the reason for discontinuation was unrelated to protocol criteria. Participants with missing values related to protocol criteria or who added FTC to their open-label TDF regimen were considered to have failed to reach the endpoint.||percentage of participants|||Number
706779|NCT00116805|Secondary|Percentage of Participants With HBsAg Loss or Seroconversion to Anti-HBs at Week 96|HBsAg loss was defined as HBsAg positive at baseline and HBsAg negative at the subsequent time point. Seroconversion to anti-HBs was defined as change of detectable antibody to HBsAg from negative at baseline to positive at the subsequent time point.|Baseline; Week 96|Participants in the Randomized and Treated Analysis Set with available data were analyzed. Data is included for participants who had discontinued unless the reason for discontinuation was unrelated to protocol criteria.||percentage of participants|||Number
706780|NCT00116805|Secondary|Percentage of Participants With Hepatitis B S-Antigen (HBsAg) Loss or Seroconversion at Week 48|HBsAg loss was defined as HBsAg positive at baseline and HBsAg negative at Week 48. Seroconversion to anti-HBs was defined as change of detectable antibody to HBsAg from negative at baseline to positive at Week 48.|Baseline; Week 48|Participants in the Randomized and Treated Analysis Set with available data were analyzed.||percentage of participants|||Number
710940|NCT00168844|Secondary|Change From Baseline in Platelets|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||10^9/L||Standard Deviation|Mean
706781|NCT00116805|Secondary|Percentage of Participants With HBeAg Loss or Seroconversion to Anti-HBe at Week 96|HBeAg loss was defined as HBeAg positive at baseline and HBeAg negative at Week 96. Seroconversion to anti-HBe was defined as change of detectable antibody to HBeAg from negative at baseline to positive at Week 96.|Baseline; Week 96|Participants in the Randomized and Treated Analysis Set who were HBeAg-positive at baseline and with available data were analyzed. Data included for participants who had discontinued unless the reason for discontinuation was unrelated to protocol criteria.||percentage of participants|||Number
706782|NCT00116805|Secondary|Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss/Seroconversion at Week 48|HBeAg loss was defined as HBeAg positive at baseline and HBeAg negative at Week 48. Seroconversion to anti-HBe was defined as change of detectable antibody to HBeAg from negative at baseline to positive at Week 48.|Baseline; Week 48|Participants in the Randomized and Treated Analysis Set who were HBeAg-positive at baseline and with available data were analyzed.||percentage of participants|||Number
706783|NCT00116805|Secondary|Change From Week 48 in ALT at Weeks 96, 144, 192, 240, 288, 336, 384, 432, and 480||Week 48; Weeks 96, 144, 192, 240, 288, 336, 384, 432, and 480|Participants in the Randomized and Treated Analysis Set with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added FTC to their open-label TDF regimen were included in the analysis.||U/L||Standard Deviation|Mean
706784|NCT00116805|Secondary|Change From Baseline in ALT at Weeks 48, 96, 144, 192, 240, 288, 336, 384, 432, and 480||Baseline; Weeks 48, 96, 144, 192, 240, 288, 336, 384, 432, and 480|Participants in the Randomized and Treated Analysis Set with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added FTC to their open-label TDF regimen were included in the analysis.||U/L||Standard Deviation|Mean
706785|NCT00116805|Secondary|Percentage of Participants With ALT Normalization at Weeks 432 and 480|ALT normalization was defined as ALT > ULN at baseline and within the normal range at the subsequent time point. The ULN was 43 U/L for males and 34 U/L for females aged 18 to < 69, and 35 U/L for males and 32 U/L for females aged ≥ 69.|Baseline; Weeks 432 and 480|Participants in the Randomized and Treated Analysis Set with ALT > ULN at baseline and with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added FTC to their open-label TDF regimen were included in the analysis.||percentage of participants|||Number
706786|NCT00116805|Secondary|Percentage of Participants With ALT Normalization at Weeks 144, 192, 240, 288, 336, and 384|ALT normalization was defined as ALT > ULN at baseline and within the normal range at the subsequent time point. The ULN was 43 U/L for males and 34 U/L for females aged 18 to < 69, and 35 U/L for males and 32 U/L for females aged ≥ 69.|Baseline; Weeks 144, 192, 240, 288, 336, and 384|Participants in the Randomized and Treated Analysis Set with ALT > ULN at baseline and available data were analyzed. Data included for participants who had discontinued unless the reason for discontinuation was unrelated to protocol criteria; data for participants who added FTC to their open-label TDF regimen were included in the analysis.||percentage of participants|||Number
706787|NCT00116805|Secondary|Percentage of Participants With ALT Normalization at Week 96|ALT normalization was defined as ALT > ULN at baseline and within the normal range at Week 96. The ULN was 43 U/L for males and 34 U/L for females aged 18 to < 69, and 35 U/L for males and 32 U/L for females aged ≥ 69.|Baseline; Week 96|Participants in the Randomized and Treated Analysis Set with ALT > ULN at baseline. Data included for participants who had discontinued unless the reason for discontinuation was unrelated to protocol criteria; data for participants who added FTC to their open-label TDF regimen were included in the analysis.||percentage of participants|||Number
706788|NCT00116805|Secondary|Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48|ALT normalization was defined as ALT > upper limit of normal (ULN) at baseline and within the normal range at the end of blinded treatment. The ULN was 43 U/L for males and 34 U/L for females aged 18 to < 69, and 35 U/L for males and 32 U/L for females aged ≥ 69.|Baseline; Week 48|Participants in the Randomized and Treated Analysis Set with ALT > ULN at baseline were analyzed; the missing-equals-failure approach was used where participants with missing data were considered to have failed to reach the endpoint.||percentage of participants|||Number
706789|NCT00116805|Secondary|Ranked Assessment of Necroinflammation and Fibrosis at Week 240|Participants were ranked as having improvement, no change, worsening, or missing data (compared to Baseline) based on the Knodell scoring system, and results are presented as the percentage of participants in each category. The Knodell necroinflammatory score is the combined score for necrosis and inflammation domains of the Knodell scoring system, which ranges from 0 (best) to 14 (worst). The Knodell fibrosis domain score ranges from 0 (best) to 4 (worst). A decrease of 1 point or more indicated improvement, and an increase of 1 point or more indicated worsening.|Baseline; Week 240|Participants in the Randomized and Treated Analysis Set with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added FTC to their open-label TDF regimen were included in the analysis.||percentage of participants|||Number
706790|NCT00116805|Secondary|Ranked Assessment of Necroinflammation and Fibrosis at Week 48|Participants were ranked as having improvement, no change, worsening, or missing data (compared to Baseline) based on the Knodell scoring system, and results are presented as the percentage of participants in each category. The Knodell necroinflammatory score is the combined score for necrosis and inflammation domains of the Knodell scoring system, which ranges from 0 (best) to 14 (worst). The Knodell fibrosis domain score ranges from 0 (best) to 4 (worst). A decrease of 1 point or more indicated improvement, and an increase of 1 point or more indicated worsening.|Baseline; Week 48|Randomized and Treated Analysis Set; the missing-equals-failure approach was used where participants with missing data were considered to have failed to reach the endpoint.||percentage of participants|||Number
706804|NCT00116831|Secondary|Number of Participants With the Indicated Treatment Emergent Major Cardiovascular Events (MACE) for All-cause Death, Non-fatal MI, Non-fatal Stroke, Coronary Revascularization, or Hospitalization for Recurrent Myocardial Ischemia (MACE Composite 1)|This was 1 of 2 MACE composite endpoints and was a secondary efficacy endpoint.|Baseline to Month 21|Safety Population||Participants|||Number
706805|NCT00116831|Secondary|Change From Baseline to Month 18 in LDL-c/HDL-c Ratio|From repeated measures analysis model: Change = baseline + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.|Baseline to Month 18|ITT Population without LOCF||ratio||Standard Error|Mean
706791|NCT00116805|Secondary|Change From Baseline in Knodell and Ishak Necroinflammatory Scores at Week 240|The Knodell necroinflammatory score is the combined score for necrosis and inflammation domains of the Knodell scoring system, and ranges from 0 (best) to 14 (worst). The Ishak score measures the degree of liver fibrosis (scarring) caused by chronic necroinflammation (inflammation leading to cell death) and ranges from 0 (best) to 6 (worst).|Baseline; Week 240|Participants in the Randomized and Treated Analysis Set with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added FTC to their open-label TDF regimen were included in the analysis.||units on a scale||Standard Deviation|Mean
706792|NCT00116805|Secondary|Change From Baseline in Knodell and Ishak Necroinflammatory Scores at Week 48|The Knodell necroinflammatory score is the combined score for necrosis and inflammation domains of the Knodell scoring system, and ranges from 0 (best) to 14 (worst). The Ishak score measures the degree of liver fibrosis (scarring) caused by chronic necroinflammation (inflammation leading to cell death) and ranges from 0 (best) to 6 (worst).|Baseline; Week 48|Participants in the Randomized and Treated Analysis Set with measurements at Baseline and Week 48 were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis.||units on a scale||Standard Deviation|Mean
706793|NCT00116805|Secondary|Percentage of Participants With Histological Response at Week 240|Histological response was based on the Knodell numerical scoring of liver biopsy specimens and defined as at least a 2-point reduction in Knodell necroinflammatory score without worsening in Knodell fibrosis score. The Knodell necroinflammatory score is the combined necrosis and inflammation domain scores and ranges from 0 to 14; the Knodell fibrosis domain score ranges from 0 to 4.|Baseline; Week 240|Participants in the Randomized and Treated Analysis Set with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added FTC to their open-label TDF regimen were included in the analysis.||percentage of participants|||Number
706794|NCT00116805|Secondary|Percentage of Participants With Histological Response at Week 48|Histological response was based on the Knodell numerical scoring of liver biopsy specimens and defined as at least a 2-point reduction in Knodell necroinflammatory score without worsening in Knodell fibrosis score. The Knodell necroinflammatory score is the combined necrosis and inflammation domain scores and ranges from 0 to 14; the Knodell fibrosis domain score ranges from 0 to 4.|Baseline; Week 48|Randomized and Treated Analysis Set; the missing-equals-failure approach was used where participants with missing data were considered to have failed to reach the endpoint.||percentage of participants|||Number
706795|NCT00116805|Secondary|Change From Week 48 in HBV DNA at Weeks 96, 144, 192, 240, 288, 336, 384, 432, and 480||Week 48; Weeks 96, 144, 192, 240, 288, 336, 384, 432, and 480|Participants in the Randomized and Treated Analysis Set with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added FTC to their open-label TDF regimen were included in the analysis.||log10 IU/mL||Standard Deviation|Mean
706796|NCT00116805|Secondary|Change From Baseline in HBV DNA at Weeks 48, 96, 144, 192, 240, 288, 336, 384, 432, and 480||Baseline; Weeks 48, 96, 144, 192, 240, 288, 336, 384, 432, and 480|Participants in the Randomized and Treated Analysis Set with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added FTC to their open-label TDF regimen were included in the analysis.||log10 IU/mL||Standard Deviation|Mean
706797|NCT00116805|Secondary|Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 432 and 480||Weeks 432 and 480|Participants in the Randomized and Treated Analysis Set with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added emtricitabine to their open-label TDF regimen were included in the analysis.||percentage of participants|||Number
706798|NCT00116805|Secondary|Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 144, 192, 240, 288, 336, and 384||Weeks 144, 192, 240, 288, 336, and 384|Randomized and Treated Analysis Set. Data included for participants who had discontinued unless the reason for discontinuation was unrelated to protocol criteria. Participants with missing values related to protocol criteria or who added FTC to their open-label TDF regimen were considered to have failed to reach the endpoint.||percentage of participants|||Number
706799|NCT00116805|Secondary|Percentage of Participants With HBV DNA < 400 Copies/mL at Week 96||Week 96|Participants in the Randomized and Treated Analysis Set with available data were analyzed. Data included for participants who discontinued study unless the discontinuation was unrelated to protocol criteria.||percentage of participants|||Number
706800|NCT00116805|Secondary|Percentage of Participants With HBV DNA < 400 Copies/mL at Week 48||Week 48|Randomized and Treated Analysis Set; the missing-equals-failure approach was used where participants with missing data were considered to have failed to reach the endpoint.||percentage of participants|||Number
706801|NCT00116805|Primary|Percentage of Participants With HBV DNA < 400 Copies/mL and Histological Improvement (2-point Reduction in Knodell Necroinflammatory Score Without Worsening in Knodell Fibrosis Score) at Week 48|"Complete response was a composite endpoint defined as histological response and HBV DNA < 400 copies/mL. Histological response was based on the Knodell numerical scoring of liver biopsy specimens and defined as at least a 2-point reduction in Knodell necroinflammatory score without worsening in Knodell fibrosis score. The Knodell necroinflammatory score is the combined necrosis and inflammation domain scores and ranges from 0 to 14; the Knodell fibrosis domain score ranges from 0 to 4.
A participant was a nonresponder for the primary endpoint if either biopsy (baseline or end-of-treatment) was missing or if there was not an HBV DNA value available at or beyond Week 40."|Baseline; Week 48|Randomized and Treated Analysis Set: all participants who were randomized and received at least one dose of study medication; the missing-equals-failure approach was used where participants with missing data were considered to have failed to reach the endpoint.||percentage of participants|||Number
706802|NCT00116831|Secondary|Number of Other Cardiovascular Events|This was one of the secondary endpoints of the study.|Baseline to Month 21|Safety Population||Number of events|||Number
706803|NCT00116831|Secondary|Number of Participants With the Indicated Treatment Emergent Major Cardiovascular Events (MACE) for Cardiovascular Death, Nonfatal MI, or Nonfatal Stroke (MACE Composite 2)|This was 1 of 2 MACE composite endpoints and was a secondary efficacy endpoint.|Baseline to Month 21|Safety Population||Participants|||Number
706810|NCT00116831|Secondary|Percent Change From Baseline to Month 18 in Triglycerides (TG)|Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.|Baseline to Month 18|ITT Population without LOCF||percent change|||Number
706811|NCT00116831|Secondary|Percent Change From Baseline to Month 18 in Low Density Lipoprotein Cholesterol (LDL-c)|Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.|Baseline to Month 18|ITT Population without LOCF||percent change|||Number
706812|NCT00116831|Secondary|Percent Change From Baseline to Month 18 in HDL-3|Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.|Baseline to Month 18|ITT Population without LOCF||percent change|||Number
706813|NCT00116831|Secondary|Percent Change From Baseline to Month 18 in HDL-2|Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.|Baseline to Month 18|ITT Population without LOCF||percent change|||Number
706814|NCT00116831|Secondary|Percent Change From Baseline to Month 18 in High Density Lipoprotein Cholesterol (HDL-c)|Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.|Baseline to Month 18|ITT Population without LOCF||percent change|||Number
706815|NCT00116831|Secondary|Percent Change From Baseline to Month 18 in Total Cholesterol (TC)|Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.|Baseline to Month 18|ITT Population without LOCF||percent change|||Number
706816|NCT00116831|Secondary|Model Adjusted Percent Change in Brain Natriuretic Peptide (BNP) From Baseline to Month 18|It was measured as ratio to baseline as percentage change based on log-transformed data : 100 x (exp(Mean change on log scale) - 1). Model Adjusted change based on ANCOVA: Log(value) - log(Baseline) = log(Baseline) + sex + region + treatment + prior OAD + cardiac procedure.|Baseline to Month 18|ITT Population with LOCF||percent change|||Number
706817|NCT00116831|Secondary|Percent Change in Brain Natriuretic Peptide (BNP) From Baseline to Month 18|It was measured as ratio to baseline as percentage change based on log-transformed data : 100 x (exp(Mean change on log scale) - 1)It was measured as ratio to baseline as percentage change based on log-transformed data : 100 x (exp(Mean change on log scale) - 1). Ratio to baseline as %change mean (%) was used as the estimation parameter for both groups.|Baseline to Month 18|ITT Population with LOCF||percent change|||Number
706818|NCT00116831|Secondary|Repeated Measures Analysis of Percent Change in MMP 9 From Baseline to Month 18|Changes in cardiovascular biomarkers from Baseline to Month 18, such as matrix metalloproteinase-9 (MMP-9). Repeated measures analysis model: Log(value) - log(baseline) = log(baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.|Baseline to Month 18|ITT Population without LOCF||percent change|||Number
706819|NCT00116831|Secondary|Repeated Measures Analysis of Percent Change in hsCRP From Baseline to Month 18|Changes in cardiovascular biomarkers from Baseline to Month 18, such as high sensitivity C-reactive protein (hsCRP) . Repeated measures analysis model: Log(value) - log(baseline) = log(baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.|Baseline to Month 18|ITT Population without LOCF||percent change|||Number
706820|NCT00116831|Secondary|Model Adjusted Change in Fasting Plasma Glucose (FPG) From Baseline to Month 18|From repeated measures analysis model: Change = Baseline + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.|Baseline to Month 18|ITT Population without LOCF||millimole/Liter (mmol/L)||Standard Error|Mean
706821|NCT00116831|Secondary|Model Adjusted Change in Glycated Hemoglobin (HbA1c) From Baseline to Month 18|From repeated measures analysis model: Change = Baseline + visit + sex + region + treatment + prior Oral Anti-Hyperglycemic Diabetic Medications(s) (OAD) + cardiac procedure + treatment x visit.|Baseline to Month 18|Intent-to-Treat (ITT) Population without Last Observation Carried Forward (LOCF). ITT population was defined as all participants in the study who were randomized and have at least one on-therapy value for an efficacy assessment.||Percentage||Standard Error|Mean
706822|NCT00116831|Secondary|Model Adjusted Change in Atheroma Area Within the 10 mm of the Non-intervened Vessel Segment With the Greatest Atheroma Volume at Baseline|IVUS-derived endpoints measured within the same 10 mm segment of non-intervened coronary arteries with the greatest degree of atheroma volume at Baseline, from Baseline to Month 18, including the nominal change in atheroma volume and atheroma area. Model Adjusted Change = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication.|Baseline to Month 18|IVUS Evaluable Population with last observation carried forward (LOCF)||millimeters squared (mm2)||Standard Error|Mean
706823|NCT00116831|Secondary|Change in Atheroma Area Within the 10 mm of the Non-intervened Vessel Segment With the Greatest Atheroma Volume at Baseline|IVUS-derived endpoints measured within the same 10 mm segment of non-intervened coronary arteries with the greatest degree of atheroma volume at Baseline, from Baseline to Month 18, including the nominal change in atheroma volume and atheroma area|Baseline to Month 18|IVUS Evaluable Population with last observation carried forward (LOCF)||millimeters squared (mm2)||Standard Deviation|Mean
706824|NCT00116831|Secondary|Model Adjusted Change in Atheroma Volume Within the 10 mm of the Non-intervened Vessel Segment With the Greatest Atheroma Volume at Baseline|IVUS-derived endpoints measured within the same 10 mm segment of non-intervened coronary arteries with the greatest degree of atheroma volume at Baseline, from Baseline to Month 18, including the nominal change in atheroma volume and atheroma area. Model Adjusted Change = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication.|Baseline to Month 18|IVUS Evaluable Population with last observation carried forward (LOCF)||millimeters cubed (mm3)||Standard Error|Mean
706825|NCT00116831|Secondary|Change in Atheroma Volume Within the 10 mm of the Non-intervened Vessel Segment With the Greatest Atheroma Volume at Baseline|IVUS-derived endpoints measured within the same 10 mm segment of non-intervened coronary arteries with the greatest degree of atheroma volume at Baseline, from Baseline to Month 18, including the nominal change in atheroma volume and atheroma area|Baseline to Month 18|IVUS Evaluable Population with last observation carried forward (LOCF)||millimeters cubed (mm3)||Standard Deviation|Mean
708762|NCT00144170|Secondary|Virologic Response at Week 96|Virologic response defined as Viral Load<400 copies/mL|week 96|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
706826|NCT00116831|Secondary|Model Adjusted Change From Baseline in Normalized Atheroma Volume|IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18. Normalized atheroma volume is defined as mean atheroma area x median segment length in cohort. Model Adjusted Change = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication.|Baseline to Month 18|IVUS Evaluable Population||millimeters cubed (mm3)||Standard Error|Mean
706827|NCT00116831|Primary|Model Adjusted Change From Baseline in Percent Atheroma Volume (PAV) to Month 18|Model Adjusted Change (MAC) = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior Oral Anti-Hyperglycemic Diabetic Medications(s) (OAD).|Baseline to Month 18|IVUS Evaluable Population (Defined as all randomized participants who received at least one dose of study medication, with an evaluable Baseline and exit [≥ 9 months] IVUS imaging assessment.)||percent (absolute change)||Standard Error|Mean
706828|NCT00116831|Primary|Change From Baseline in Percent Atheroma Volume (PAV) to Month 18|The primary efficacy endpoint was change in PAV (defined as total atheroma volume divided by total vessel volume x 100) within a 40 mm segment in non-intervened coronary arteries from Baseline to Month 18, based upon Intravascular Ultrasound (IVUS) assessment.|Baseline to Month 18|IVUS Evaluable Population (Defined as all randomized participants who received at least one dose of study medication, with an evaluable Baseline and exit [≥ 9 months] IVUS imaging assessment.)||percent (absolute change)||Standard Deviation|Mean
706829|NCT00116831|Secondary|Change From Baseline in Normalized Atheroma Volume|IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18. Normalized atheroma volume is defined as mean atheroma area x median segment length in cohort.|Baseline to Month 18|IVUS Evaluable Population||millimeters cubed (mm3)||Standard Deviation|Mean
706830|NCT00116831|Secondary|Model Adjusted Change From Baseline in Vessel Area to Month 18|IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18. Model Adjusted Change (MAC) = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication.|Baseline to Month 18|IVUS Evaluable Population||millimeters square (mm2)||Standard Error|Mean
706831|NCT00116831|Secondary|Model Adjusted Change From Baseline in Lumen Area to Month 18|IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18. Model Adjusted Change (MAC) = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication.|Baseline to Month 18|IVUS Evaluable Population||millimeters square (mm2)||Standard Error|Mean
706832|NCT00116831|Secondary|Model Adjusted Change From Baseline in Atheroma Area to Month 18|IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18. Model Adjusted Change (MAC) = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication.|Baseline to Month 18|IVUS Evaluable Population||millimeters square (mm2)||Standard Error|Mean
706833|NCT00116831|Secondary|Change From Baseline in Atheroma, Vessel, and Lumen Area to Month 18|IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18|Baseline to Month 18|IVUS Evaluable Population||millimeters squared (mm2)||Standard Deviation|Mean
706834|NCT00116831|Secondary|Model Adjusted Change From Baseline in Vessel Volume to Month 18|IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18. Model Adjusted Change (MAC) = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication.|Baseline to Month 18|IVUS Evaluable Population||millimeters cubed (mm3)||Standard Error|Mean
706835|NCT00116831|Secondary|Model Adjusted Change From Baseline in Lumen Volume to Month 18|IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18. Model Adjusted Change (MAC) = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication.|Baseline to Month 18|IVUS Evaluable Population||millimeters cubed (mm3)||Standard Error|Mean
706836|NCT00116831|Secondary|Model Adjusted Change From Baseline in Atheroma Volume to Month 18|IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18. Model Adjusted Change (MAC) = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication.|Baseline to Month 18|IVUS Evaluable Population||millimeters cubed (mm3)||Standard Error|Mean
706837|NCT00116831|Secondary|Change From Baseline in Atheroma, Vessel, and Lumen Volume to Month 18|IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18|Baseline to Month 18|IVUS Evaluable Population||millimeters cubed (mm3)||Standard Deviation|Mean
706838|NCT00117156|Post-Hoc|Delayed Pneumonia Toxicity Rate|Delayed pneumonia toxicity rate is the proportion of patients who experienced significant pneumonia toxicity defined as nocardia or pneumocystis jiroveci after completing therapy.|Assessed after therapy completion incidentally or at a minimum every 6 months for 2 years and then annually up to 4 years.|The analysis dataset is comprised of all treated patients.||proportion of patients||95% Confidence Interval|Number
706839|NCT00117156|Post-Hoc|Delayed Bone Marrow Toxicity Rate|Delayed bone marrow toxicity rate is the proportion of patients who experienced significant bone marrow toxicity defined as aplastic anemia or myelodysplastic syndromes (MDS) after completing therapy.|Assessed after therapy completion incidentally or at a minimum every 6 months for 2 years and then annually up to 4 years.|The analysis dataset is comprised of all treated patients.||proportion of patients||95% Confidence Interval|Number
706840|NCT00117156|Secondary|3.1-Year Overall Survival|3.1-year overall survival is the probability of patients remaining alive 3.1 years from study entry.|Assessed after 3- and 6-cycles of therapy, every 6 months for 2 years and then annually up to 4 years|The analysis dataset is comprised of all treated patients.||probability||95% Confidence Interval|Number
706841|NCT00117156|Secondary|3.1-Year Progression-Free Survival|3.1-year progression-free survival is the probability of patients remaining alive and progression-free at 3.1 years from study entry estimated using Kaplan-Meier methods. Disease progression was assessed per Cheson criteria (1999).|Assessed after 3- and 6-cycles of therapy, every 6 months for 2 years and then annually up to 4 years|The analysis dataset is comprised of all treated patients.||probability||95% Confidence Interval|Number
706842|NCT00117156|Primary|Objective Response Rate|Objective response rate is defined as the proportion of patients who achieve complete remission (CR), complete remission/unconfirmed (CRu) or partial remission (PR) based on Cheson criteria (1999).|Assessed after three- and six-cycles of therapy.|The analysis dataset is comprised of all treated patients.||proportion of patients||95% Confidence Interval|Number
706843|NCT00117286|Primary|Liver Function Tests|The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases >3x ULN and ALT increases >3x ULN with concurrently increased bilirubin >1.5 ULN.|5 years|The data include data from participants participating in both the main study (FE200486 CS14) and the extension study FE200486 CS14A.||participants|||Number
706844|NCT00117286|Primary|Participants With Markedly Abnormal Change in Vital Signs and Body Weight|This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of participants in each group with normal baseline and markedly abnormal value post-baseline.|5 years|The data include data from participants participating in both the main study (FE200486 CS14) and the extension study FE200486 CS14A.||participants|||Number
706845|NCT00117312|Primary|Participants With Markedly Abnormal Change in Vital Signs and Body Weight|Vital signs and body weight included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of participants in each group with normal baseline and markedly abnormal value post-baseline.|3 years|These data include patients from the main study (FE200486 CS06) and the extension study (FE200486 CS06A).||participants|||Number
706846|NCT00117312|Primary|Liver Function Tests|The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases >3x ULN and ALT increases >3x ULN with concurrently increased bilirubin >1.5 ULN.|3 years|The data include patients from both the main study (FE200486 CS06) and the extension study FE200486 CS06A.||participants|||Number
706847|NCT00117338|Secondary|Total Dose of β-agonist Administered Per Patient Over a Period of 2 Hours Following the End of Study Drug Administration|Median total dose of β-agonist administered per patient over a period of 2 hours following the end of study drug administration.|120 minutes|At least one post-randomization measurement obtained subsequent to at least one dose of study treatment was required for inclusion in the analysis of total doses of Beta-Agonist (mg) endpoint.||mg||Inter-Quartile Range|Median
706848|NCT00117338|Secondary|Change in FEV1 After 15 Minutes Following the End of Study Drug Administration|Improvement in FEV1 as the time-weighted average change from baseline over the first 15 minutes following the end of study drug administration. Change = 15 minutes value minus Baseline value|Baseline and 15 Minutes|Full Analysis Set (FAS). The FAS population includes all randomized patients who received double-blind study drug, and with efficacy measurements both at baseline and at least one time point over the time interval considered.||Liters||95% Confidence Interval|Least Squares Mean
706849|NCT00117338|Secondary|Time-Weighted Average Change in FEV1 Over 30 Minutes Following the End of Study Drug Administration|Improvement in FEV1 as the time-weighted average change from baseline over 30 minutes following the end of study drug administration. Time-weighted average of the changes from baseline obtained over the 30 minutes (at 30 and 15) with the time interval between any measurement and the measurement prior to it used as the weighting factor.|Baseline and (time-weighted average over) 30 Minutes|Full Analysis Set (FAS). The FAS population includes all randomized patients who received double-blind study drug, and with efficacy measurements both at baseline and at least one time point over the time interval considered.||Liters||95% Confidence Interval|Least Squares Mean
706850|NCT00117338|Secondary|Time-Weighted Average Change in FEV1 Over 45 Minutes Following the End of Study Drug Administration|Improvement in FEV1 as time-weighted average change from baseline over 45 minutes following the end of study drug administration: Time-weighted average of the changes from baseline obtained over the 45 minutes (at 45, 30 and 15) with the time interval between any measurement and the measurement prior to it used as the weighting factor.|Baseline and (time-weighed average over) 45 Minutes|Full Analysis Set (FAS). The FAS population includes all randomized patients who received double-blind study drug, and with efficacy measurements both at baseline and at least one time point over the time interval considered.||Liters||95% Confidence Interval|Least Squares Mean
706851|NCT00117338|Secondary|Number of Participants With Treatment Failure (Hospitalization or Time to Decision to Discharge > 2 Hours)|Treatment Failure is defined as a.) patients who required hospitalization, or b.) patients for whom a decision to discharge home has not been reached by 2 hours following the end of study drug administration.|120 minutes|Full Analysis Set (FAS). At least one post-randomization measurement obtained subsequent to at least one dose of study treatment was required for inclusion in the analysis of treatment failure endpoint. Baseline FEV1 measurement was also required to assess this endpoint since it was included in the model.||Participants|||Number
706852|NCT00117338|Secondary|Change From Baseline in Modified Pulmonary Index [mPI] Score|"Change from baseline in modified pulmonary index [mPI] score assessed 60 minutes following the end of study drug administration. mPI questionnaire scores each component on a scale of 0 to 3 (low to high) with a total possible score of 12.
The components are respiratory rate, wheezing, prolongation of expiration (Inspiratory:Expiratory ratio), and accessory muscle use."|Baseline and 60 minutes|Full Analysis Set (FAS). The FAS population includes all randomized patients who received double-blind study drug, and with efficacy measurements both at baseline and at least one time point over the time interval considered.||Score on a scale||95% Confidence Interval|Least Squares Mean
706853|NCT00117338|Primary|Improvement in FEV1 (Forced Expiratory Volume in 1 Second) Over the First 60 Minutes After Administration|Improvement in FEV1 as the time-weighted average change from baseline over 60 minutes following the end of study drug administration. Time-weighted average of the changes from baseline obtained over the 60 minutes (at 60, 45, 30 and 15) with the time interval between any measurement and the measurement prior to it used as the weighting factor.|Baseline and (time weighted average over) 60 Minutes|Full Analysis Set (FAS). The FAS population includes all randomized patients who received double-blind study drug, and with efficacy measurements both at baseline and at least one time point over the time interval considered.||Liters||95% Confidence Interval|Least Squares Mean
706926|NCT00117676|Secondary|Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 96||Week 96|Participants in the Randomized and Treated Analysis Set with available data were analyzed. Data included for participants who had discontinued unless the reason for discontinuation was unrelated to protocol criteria.||percentage of participants|||Number
706854|NCT00117559|Primary|BDI|"Beck Depression Inventory - measures depression. Range for Total score = 0 to 63 Higher scores are indicative of increased depression
The Beck Depression Inventory (BDI; Beck & Steer, 1988) is a widely used 21-item self-report instrument designed to assess depressive mood and symptoms. Each item is rated on a 4-point scale ranging from 0 to 3, with higher scores reflecting greater severity of depressive symptoms for the past two weeks. A sample item is “I do not feel sad.” The BDI has demonstrated reliability (split-half reliability coefficient of .93) and validity (correlations with clinician ratings of depression range from .62 to .75; Beck, Steer, & Garbing, 1988). Cronbach’s alpha was high for the present sample at both time points (a = .91 and .90)."|8 weeks|||units on a scale||Standard Deviation|Mean
706855|NCT00117585|Primary|Orthostatic Hypotension at Discharge|Participants are assessed for orthostatic hypotension up to one time per day. The outcome measure is the last three days prior to discharge that blood pressures were assessed for orthostatic hypotension.|Last three blood pressures prior to discharge|||participants|||Number
706863|NCT00117637|Secondary|Analysis of the Eastern Co-operative Oncology Group (ECOG) Status at the End of the Second Intervention Period|Eastern Cooperative Oncology Group (ECOG) Performance Status is a scale that measures how cancer affects the daily life of a patient on an ordinal scale from grade 0 (best) to grade 5 (worst).|From randomization of the first subject until 3 years and 9 months later, assessed every 4 weeks|At the time of the analysis, only 45 subjects in Sorafenib 400/600 mg bid group and 58 in Interferon/Sorafenib 400 mg bid group were documented by study investigators due to various reasons (drop-out of patients by AEs, death etc.)||participant s|||Number
706864|NCT00117637|Secondary|Analysis of the Eastern Co-operative Oncology Group (ECOG) Status at the End of the First Intervention Period|Eastern Cooperative Oncology Group (ECOG) Performance Status is a scale that measures how cancer affects the daily life of a patient on an ordinal scale from grade 0 (best) to grade 5 (worst).|From randomization of the first subject until 3 years and 9 months later, assessed every 4 weeks|At the time of the analysis, only 95 subjects in Sorafenib 400 mg bid group and 89 in Interferon group were documented by study investigators due to various reasons (drop-out of patients by AEs, death etc.)||participants|||Number
706865|NCT00117637|Secondary|Time to Response According to the Investigator Assessment for the Second Intervention Period|Time to Response (TTR) for subjects who achieved a response (Complete Response (CR) or Partial Response (PR) with confirmation) was defined as the time from date of randomization to the earliest date that the response was first documented|From randomization of the first subject until 3 years and 9 months later, assessed every 4 weeks|||months||Full Range|Median
706866|NCT00117637|Secondary|Time to Response According to the Investigator Assessment for the First Intervention Period|Time to Response (TTR) for subjects who achieved a response (Complete Response (CR) or Partial Response (PR) with confirmation was defined as the time from date of randomization to the earliest date that the response was first documented|From randomization of the first subject until 3 years and 9 months later, assessed every 4 weeks|||months||Full Range|Median
706867|NCT00117637|Secondary|Time to Response According to the Independent Radiological Review for the First Intervention Period|Time to Response (TTR) for subjects who achieved a response (Complete Response (CR) or Partial Response (PR) with confirmation was defined as the time from date of randomization to the earliest date that the response was first documented|From randomization of the first subject until 15 months later, assessed every 8 weeks|||months||Full Range|Median
708763|NCT00144170|Secondary|Virologic Response at Week 88|Virologic response defined as Viral Load<400 copies/mL|week 88|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
706868|NCT00117637|Secondary|Duration of Response According to the Investigator Assessment for the Second Intervention Period|Duration of Response was defined as the time from date of first response (Complete Response (CR) or Partial Response (PR)) to the date when Progressive Disease (PD) is first documented or to the date of death, whichever occurs first. Subjects still having CR or PR at the time of analysis were censored at their last date of last contact|From randomization of the first subject until 3 years and 9 months later, assessed every 8 weeks|||months||Full Range|Median
706869|NCT00117637|Secondary|Duration of Response According to the Investigator Assessment for the First Intervention Period|Duration of Response was defined as the time from date of first response (Complete Response (CR) or Partial Response (PR)) to the date when Progressive Disease (PD) is first documented or to the date of death, whichever occurs first. Subjects still having CR or PR at the time of analysis were censored at their last date of last contact|From randomization of the first subject until 3 years and 9 months later, assessed every 8 weeks|||months||Full Range|Median
706870|NCT00117637|Secondary|Duration of Response According to the Independent Radiological Review for the First Intervention Period|Duration of Response was defined as the time from date of first response (Complete Response (CR) or Partial Response (PR)) to the date when Progressive Disease (PD) is first documented or to the date of death, whichever occurs first. Subjects still having CR or PR at the time of analysis were censored at their last date of last contact|From randomization of the first subject until 15 months later, assessed every 8 weeks|||months||Full Range|Median
706871|NCT00117637|Secondary|Average of All Trough Plasma Concentrations|Plasma samples were collected prior to dosing every 4 weeks after the patient reached steady-state (at least 10 days at 400 mg BID).|From start of treatment of the first subject until 15 months later assessed every 4 weeks.|Patients who started on Sorafenib, not Interferon, and had been at the same dose (400 mg or 600 mg BID) for at least 10 days were considered valid for the analysis. Concentrations collected between 10-14 hours from the last dose were included in the analysis.||100*mg/L||95% Confidence Interval|Geometric Mean
706872|NCT00117637|Secondary|Slope - Change in Trough Concentration/Cycle|Plasma samples were collected prior to dosing every 4 weeks after the patient reached steady-state (at least 10 days at 400 mg BID (bis in die, twice daily)) to assess any potential trends in trough concentration over time.|From start of treatment of the first subject until 15 months later assessed every 4 weeks.|Patients who started on Sorafenib, not Interferon, and had been at the same dose (400 mg) for at least 10 days were considered valid for the analysis. Concentrations collected between 10-14 hours from the last dose were included in the analysis.||100*(mg/L/cycle)||95% Confidence Interval|Mean
706873|NCT00117637|Secondary|Overall Survival (OS)|Overall Survival was defined as the time from date of randomization to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact|From randomization of the first subject until 3 years and 9 months later, assessed every 8 weeks|||months||95% Confidence Interval|Median
706874|NCT00117637|Secondary|Progression Free Survival According to the Investigator Assessment (Second Intervention Period)|Progression-free Survival (PFS) was defined as the time from date of randomization to disease progression (radiological or clinical or death due to any cause, whichever occurs first). Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation|From randomization of the first subject until 3 years and 9 months later, assessed every 8 weeks|||months||95% Confidence Interval|Median
706875|NCT00117637|Secondary|Tumor Response According to the Investigator Assessment for the Second Intervention Period|Tumor Response (= Best Overall Response) of a subject was defined as the best tumor response (confirmed Complete Response (CR), confirmed Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)) observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR was defined as disappearance of tumor lesions, PR was defined as a decrease of at least 30% in the sum of tumor lesion sizes, SD was defined as steady state of disease, PD was defined as an increase of at least 20% in the sum of tumor lesions sizes|From randomization of the first subject until 3 years and 9 months later, assessed every 8 weeks|||participants|||Number
706876|NCT00117637|Secondary|Tumor Response According to the Investigator Assessment for the First Intervention Period|Tumor Response (= Best Overall Response) of a subject was defined as the best tumor response (confirmed Complete Response (CR), confirmed Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)) observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR was defined as disappearance of tumor lesions, PR was defined as a decrease of at least 30% in the sum of tumor lesion sizes, SD was defined as steady state of disease, PD was defined as an increase of at least 20% in the sum of tumor lesions sizes|From randomization of the first subject until 3 years and 9 months later, assessed every 8 weeks|||participants|||Number
706877|NCT00117637|Secondary|Tumor Response According to the Independent Radiological Review for the First Intervention Period|Tumor Response (= Best Overall Response) of a subject was defined as the best tumor response (confirmed Complete Response (CR), confirmed Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)) observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR was defined as disappearance of tumor lesions, PR was defined as a decrease of at least 30% in the sum of tumor lesion sizes, SD was defined as steady state of disease, PD was defined as an increase of at least 20% in the sum of tumor lesions sizes.|From randomization of the first subject until 15 months later, assessed every 8 weeks|||participants|||Number
706878|NCT00117637|Secondary|Analysis of the Treatment Tolerability (Global Satisfaction) by Use of Treatment Satisfaction Questionnaire for Medication (TSQM) for the Second Intervention Period|The TSQM comprises 14 questions dispatched within 4 domains (effectiveness, side effects, convenience, and global satisfaction). Each question was answered on either a 5-point or 7-point scale. Each domain score can vary from 0 to 100 with higher scores indicating subject reported higher effectiveness of treatment, less bothered by side-effects, more convenient use of medication and overall greater satisfaction with the treatment. No total score is calculated.|From randomization of the first subject until 15 months later, assessed every 8 weeks|The number of analyzed patients regarding quality of life parameters varied considerably due to missing questionnaires which had not been filled in by patients or invalidity of these questionnaires according to the protocol.||scores on a scale||95% Confidence Interval|Least Squares Mean
710941|NCT00168844|Secondary|Change From Baseline in White Blood Cell Count|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||10^9/Litre (L)||Standard Deviation|Mean
706879|NCT00117637|Secondary|Analysis of the Treatment Tolerability (Convenience) by Use of Treatment Satisfaction Questionnaire for Medication (TSQM) for the Second Intervention Period|The TSQM comprises 14 questions dispatched within 4 domains (effectiveness, side effects, convenience, and global satisfaction). Each question was answered on either a 5-point or 7-point scale. Each domain score can vary from 0 to 100 with higher scores indicating subject reported higher effectiveness of treatment, less bothered by side-effects, more convenient use of medication and overall greater satisfaction with the treatment. No total score is calculated.|From randomization of the first subject until 15 months later, assessed every 8 weeks|The number of analyzed patients regarding quality of life parameters varied considerably due to missing questionnaires which had not been filled in by patients or invalidity of these questionnaires according to the protocol.||scores on a scale||95% Confidence Interval|Least Squares Mean
706880|NCT00117637|Secondary|Analysis of the Treatment Tolerability (Side Effects) by Use of Treatment Satisfaction Questionnaire for Medication (TSQM) for the Second Intervention Period|The TSQM comprises 14 questions dispatched within 4 domains (effectiveness, side effects, convenience, and global satisfaction). Each question was answered on either a 5-point or 7-point scale. Each domain score can vary from 0 to 100 with higher scores indicating subject reported higher effectiveness of treatment, less bothered by side-effects, more convenient use of medication and overall greater satisfaction with the treatment. No total score is calculated.|From randomization of the first subject until 15 months later, assessed every 8 weeks|The number of analyzed patients regarding quality of life parameters varied considerably due to missing questionnaires which had not been filled in by patients or invalidity of these questionnaires according to the protocol.||scores on a scale||95% Confidence Interval|Least Squares Mean
706881|NCT00117637|Secondary|Analysis of the Treatment Tolerability (Effectiveness) by Use of Treatment Satisfaction Questionnaire for Medication (TSQM) for the Second Intervention Period|The TSQM comprises 14 questions dispatched within 4 domains (effectiveness, side effects, convenience, and global satisfaction). Each question was answered on either a 5-point or 7-point scale. Each domain score can vary from 0 to 100 with higher scores indicating subject reported higher effectiveness of treatment, less bothered by side-effects, more convenient use of medication and overall greater satisfaction with the treatment. No total score is calculated.|From randomization of the first subject until 15 months later, assessed every 8 weeks|The number of analyzed patients regarding quality of life parameters varied considerably due to missing questionnaires which had not been filled in by patients or invalidity of these questionnaires according to the protocol.||scores on a scale||95% Confidence Interval|Least Squares Mean
706882|NCT00117637|Secondary|Analysis of the Treatment Tolerability (Global Satisfaction) by Use of Treatment Satisfaction Questionnaire for Medication (TSQM) for the First Intervention Period|The TSQM comprises 14 questions dispatched within 4 domains (effectiveness, side effects, convenience, and global satisfaction). Each question was answered on either a 5-point or 7-point scale. Each domain score can vary from 0 to 100 with higher scores indicating subject reported higher effectiveness of treatment, less bothered by side-effects, more convenient use of medication and overall greater satisfaction with the treatment. No total score is calculated.|From randomization of the first subject until 15 months later, assessed every 8 weeks|The number of analyzed patients regarding quality of life parameters varied considerably due to missing questionnaires which had not been filled in by patients or invalidity of these questionnaires according to the protocol.||scores on a scale||95% Confidence Interval|Least Squares Mean
706883|NCT00117637|Secondary|Analysis of the Treatment Tolerability (Convenience) by Use of Treatment Satisfaction Questionnaire for Medication (TSQM) for the First Intervention Period|The TSQM comprises 14 questions dispatched within 4 domains (effectiveness, side effects, convenience, and global satisfaction). Each question was answered on either a 5-point or 7-point scale. Each domain score can vary from 0 to 100 with higher scores indicating subject reported higher effectiveness of treatment, less bothered by side-effects, more convenient use of medication and overall greater satisfaction with the treatment. No total score is calculated.|From randomization of the first subject until 15 months later, assessed every 8 weeks|The number of analyzed patients regarding quality of life parameters varied considerably due to missing questionnaires which had not been filled in by patients or invalidity of these questionnaires according to the protocol.||scores on a scale||95% Confidence Interval|Least Squares Mean
706884|NCT00117637|Secondary|Analysis of the Treatment Tolerability (Side Effects) by Use of Treatment Satisfaction Questionnaire for Medication (TSQM) for the First Intervention Period|The TSQM comprises 14 questions dispatched within 4 domains (effectiveness, side effects, convenience, and global satisfaction). Each question was answered on either a 5-point or 7-point scale. Each domain score can vary from 0 to 100 with higher scores indicating subject reported higher effectiveness of treatment, less bothered by side-effects, more convenient use of medication and overall greater satisfaction with the treatment. No total score is calculated.|From randomization of the first subject until 15 months later, assessed every 8 weeks|The number of analyzed patients regarding quality of life parameters varied considerably due to missing questionnaires which had not been filled in by patients or invalidity of these questionnaires according to the protocol.||scores on a scale||95% Confidence Interval|Least Squares Mean
706885|NCT00117637|Secondary|Analysis of the Treatment Tolerability (Effectiveness) by Use of Treatment Satisfaction Questionnaire for Medication (TSQM) for the First Intervention Period|The TSQM comprises 14 questions dispatched within 4 domains (effectiveness, side effects, convenience, and global satisfaction). Each question was answered on either a 5-point or 7-point scale. Each domain score can vary from 0 to 100 with higher scores indicating subject reported higher effectiveness of treatment, less bothered by side-effects, more convenient use of medication and overall greater satisfaction with the treatment. No total score is calculated.|From randomization of the first subject until 15 months later, assessed every 8 weeks|The number of analyzed patients regarding quality of life parameters varied considerably due to missing questionnaires which had not been filled in by patients or invalidity of these questionnaires according to the protocol.||scores on a scale||95% Confidence Interval|Least Squares Mean
706927|NCT00117676|Secondary|Percentage of Participants With HBV DNA < 400 Copies/mL at Week 48||Week 48|Randomized and Treated Analysis Set; the missing-equals-failure approach was used where participants with missing data were considered to have failed to reach the endpoint.||percentage of participants|||Number
708764|NCT00144170|Secondary|Virologic Response at Week 80|Virologic response defined as Viral Load<400 copies/mL|Week 80|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
706886|NCT00117637|Secondary|Analysis of the Quality of Life (QoL) by Use of Functional Assessment of Cancer Therapy-Biologic-response Modifiers (FACT-BRM) for the Second Intervention Period|The FACT-BRM comprises 40 questions within 6 domains (physical well being, social/family well being, emotional well being, additional concern: physical, and additional concern: emotional). Each question was answered on a five point scale from 0 (not at all) to 4 (very much). The total score range is from 0 to 160 with higher scores indicating better QoL.|From randomization of the first subject until 15 months later, assessed every 8 weeks|The number of analyzed patients regarding quality of life parameters varied considerably due to missing questionnaires which had not been filled in by patients or invalidity of these questionnaires according to the protocol.||scores on a scale||95% Confidence Interval|Least Squares Mean
706887|NCT00117637|Secondary|Analysis of the Quality of Life (QoL) by Use of Functional Assessment of Cancer Therapy-Biologic-response Modifiers (FACT-BRM) for the First Intervention Period|The FACT-BRM comprises 40 questions within 6 domains (physical well being, social/family well being, emotional well being, additional concern: physical, and additional concern: emotional). Each question was answered on a five point scale from 0 (not at all) to 4 (very much). The total score range is from 0 to 160 with higher scores indicating better QoL.|From randomization of the first subject until 15 months later, assessed every 8 weeks|The number of analyzed patients regarding quality of life parameters varied considerably due to missing questionnaires which had not been filled in by patients or invalidity of these questionnaires according to the protocol.||scores on a scale||95% Confidence Interval|Least Squares Mean
706888|NCT00117637|Secondary|Analysis of the Quality of Life by Use of Total Score of the Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI) for the Second Intervention Period|The FKSI questionnaire comprises 15 questions dispatched within 4 domains (respiratory, pain, general symptoms and overall Quality of Life (QoL)) plus 2 individual items. Each question was answered on a five point scale from 0 (not at all) to 4 (very much) indicating the severity of symptoms. The total score range was from 0 to 60 with higher scores indicating subjects reported fewer kidney cancer related symptoms and concerns.|From randomization of the first subject until 15 months later, assessed every 8 weeks|The number of analyzed patients regarding quality of life parameters varied considerably due to missing questionnaires which had not been filled in by patients or invalidity of these questionnaires according to the protocol.||scores on a scale||95% Confidence Interval|Least Squares Mean
706889|NCT00117637|Secondary|Analysis of the Quality of Life by Use of Total Score of the Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI) for the First Intervention Period|The FKSI questionnaire comprises 15 questions dispatched within 4 domains (respiratory, pain, general symptoms and overall Quality of Life (QoL)) plus 2 individual items. Each question was answered on a five point scale from 0 (not at all) to 4 (very much) indicating the severity of symptoms. The total score range was from 0 to 60 with higher scores indicating subjects reported fewer kidney cancer related symptoms and concerns.|From randomization of the first subject until 15 months later, assessed every 8 weeks|The number of analyzed patients regarding quality of life parameters varied considerably due to missing questionnaires which had not been filled in by patients or invalidity of these questionnaires according to the protocol.||scores on a scale||95% Confidence Interval|Least Squares Mean
706890|NCT00117637|Secondary|Analysis of the Quality of Life by Use of the Respiratory Domain of the Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI) for the Second Intervention Period|"The FKSI questionnaire comprises 15 questions dispatched within 4 domains (respiratory, pain, general symptoms and overall Quality of Life (QoL)) plus 2 individual items. Each question was answered on a five point scale from 0 (not at all) to 4 (very much) indicating the severity of symptoms. The total score range was from 0 to 60 with higher scores indicating subjects reported fewer kidney cancer related symptoms and concerns. The respiratory domain of the FKSI comprises 2 questions: I have been short in breath and I have been coughing; its score ranges from 0 to 8."|From randomization of the first subject until 15 months later, assessed every 8 weeks|The number of analyzed patients regarding quality of life parameters varied considerably due to missing questionnaires which had not been filled in by patients or invalidity of these questionnaires according to the protocol.||scores on a scale||95% Confidence Interval|Least Squares Mean
706891|NCT00117637|Secondary|Analysis of the Quality of Life by Use of the Respiratory Domain of the Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI) After Intervention for the First Intervention Period|"The FKSI questionnaire comprises 15 questions dispatched within 4 domains (respiratory, pain, general symptoms and overall Quality of Life (QoL)) plus 2 individual items. Each question was answered on a five point scale from 0 (not at all) to 4 (very much) indicating the severity of symptoms. The total score range was from 0 to 60 with higher scores indicating subjects reported fewer kidney cancer related symptoms and concerns. The respiratory domain of the FKSI comprises 2 questions: I have been short in breath and I have been coughing; its score ranges from 0 to 8."|From randomization of the first subject until 15 months later, assessed every 8 weeks|The number of analyzed patients regarding quality of life parameters varied considerably due to missing questionnaires which had not been filled in by patients or invalidity of these questionnaires according to the protocol.||scores on a scale||95% Confidence Interval|Least Squares Mean
706892|NCT00117637|Secondary|Disease Control (DC) According to the Investigator Assessment for the Second Intervention Period|Disease Control (DC) was defined as the total number of subjects whose best response was not Progressive Disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) (= total number of Complete Response (CR) + total number of Partial Response (PR) + total number of Stable Disease (SD); CR, PR, or SD had to be maintained for at least 28 days from the first demonstration of that rating). CR: disappearance of tumor lesions (TL); PR: a decrease of at least 30% in the sum of TL sizes; SD: steady state of disease; PD: an increase of at least 20% in the sum of TL sizes.|From randomization of the first subject until 3 years and 9 months later, assessed every 8 weeks|||participants|||Number
706893|NCT00117637|Secondary|Disease Control (DC) According to the Investigator Assessment for the First Intervention Period|Disease Control (DC) was defined as the total number of subjects whose best response was not Progressive Disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) (= total number of Complete Response (CR) + total number of Partial Response (PR) + total number of Stable Disease (SD); CR, PR, or SD had to be maintained for at least 28 days from the first demonstration of that rating). CR: disappearance of tumor lesions (TL); PR: a decrease of at least 30% in the sum of TL sizes; SD: steady state of disease; PD: an increase of at least 20% in the sum of TL sizes.|From randomization of the first subject until 3 years and 9 months later, assessed every 8 weeks|||participants|||Number
706894|NCT00117637|Secondary|Disease Control (DC) According to Independent Central Review for the First Intervention Period|Disease Control (DC) was defined as the total number of subjects whose best response was not Progressive Disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) (= total number of Complete Response (CR) + total number of Partial Response (PR) + total number of Stable Disease (SD); CR, PR, or SD had to be maintained for at least 28 days from the first demonstration of that rating). CR: disappearance of tumor lesions (TL); PR: a decrease of at least 30% in the sum of TL sizes; SD: steady state of disease; PD: an increase of at least 20% in the sum of TL sizes.|From randomization of the first subject until 15 months later, assessed every 8 weeks|||participants|||Number
706895|NCT00117637|Secondary|Progression-free Survival (PFS) Based on Investigator Assessment for the First Intervention Period|Progression-free Survival (PFS) was defined as the time from date of randomization to disease progression (radiological or clinical or death due to any cause, whichever occurs first). Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation|From randomization of the first subject until 3 years and 9 months later, assessed every 8 weeks|||months||95% Confidence Interval|Median
706896|NCT00117637|Primary|Progression-free Survival (PFS) Based on Independent Radiological Review for the First Intervention Period|Progression-free Survival (PFS) was defined as the time from date of randomization to disease progression (radiological or clinical or death due to any cause, whichever occurs first). Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation|From randomization of the first subject until 15 months later, assessed every 8 weeks|||months||95% Confidence Interval|Median
706897|NCT00117676|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 480 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 480 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 432 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 432 and had HBV DNA ≥ 400 copies/mL at the time of the addition.|Baseline; Weeks 433 to 480|Participants in the Randomized and Treated Analysis Set who continued on the study after Week 432 with available data were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.||participants|||Number
706898|NCT00117676|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 432 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 432 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 384 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 384 and had HBV DNA ≥ 400 copies/mL at the time of the addition.|Baseline; Weeks 385 to 432|Participants in the Randomized and Treated Analysis Set who continued on the study after Week 384 with available data were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.||participants|||Number
706899|NCT00117676|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 384 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 384 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 336 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 336 and had HBV DNA ≥ 400 copies/mL at the time of the addition.|Baseline; Weeks 337 to 384|Participants in the Randomized and Treated Analysis Set who continued on the study after Week 336 with available data were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.||participants|||Number
706900|NCT00117676|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 336 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 336 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 288 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 288 and had HBV DNA ≥ 400 copies/mL at the time of the addition.|Baseline; Weeks 289 to 336|Participants in the Randomized and Treated Analysis Set who continued on the study after Week 288 with available data were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.||participants|||Number
706901|NCT00117676|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 288 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 288 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 240 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 240 and had HBV DNA ≥ 400 copies/mL at the time of the addition.|Baseline; Weeks 241 to 288|Participants in the Randomized and Treated Analysis Set who continued on the study after Week 240 with available data were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.||participants|||Number
706902|NCT00117676|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 240 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 240 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 192 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 192 and had HBV DNA ≥ 400 copies/mL at the time of the addition.|Baseline; Weeks 193 to 240|Participants in the Randomized and Treated Analysis Set who continued on the study after Week 192 with available data were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.||participants|||Number
706903|NCT00117676|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 192 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 192 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 144 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 144 and had HBV DNA ≥ 400 copies/mL at the time of the addition.|Baseline; Weeks 145 to 192|Participants in the Randomized and Treated Analysis Set who continued on the study after Week 144 with available data were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.||participants|||Number
706904|NCT00117676|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 144 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 144 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 96 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 96 and had HBV DNA ≥ 400 copies/mL at the time of the addition.|Baseline; Weeks 97 to 144|Participants in the Randomized and Treated Analysis Set who continued on the study after Week 96 with available data were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.||participants|||Number
706905|NCT00117676|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 96 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 96 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 48 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen and had HBV DNA ≥ 400 copies/mL at the time of the addition.|Baseline; Weeks 49 to 96|Participants in the Randomized and Treated Analysis Set who continued on the study after Week 48 (ie, entered the open-label phase) were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.||participants|||Number
706906|NCT00117676|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 48 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 48, those with viral breakthrough, and those who discontinued after Week 24 with HBV DNA ≥ 400 copies/mL.|Baseline; Week 48|Participants in the Randomized and Treated Analysis Set were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.||participants|||Number
706907|NCT00117676|Secondary|Percentage of Participants With HBsAg Loss and/or Seroconversion to Anti-HBs at Weeks 144, 192, 240, 288, 336, 384, 432, and 480|HBsAg loss was defined as HBsAg positive at baseline and HBsAg negative at the subsequent time point. Seroconversion to anti-HBs was defined as change of detectable antibody to HBsAg from negative at baseline to positive at the subsequent time point.|Baseline; Weeks 144, 192, 240, 288, 336, 384, 432, and 480|Randomized and Treated Analysis Set. Data is included for participants who had discontinued unless the reason for discontinuation was unrelated to protocol criteria. Participants with missing values related to protocol criteria or who added FTC to their open-label TDF regimen were considered to have failed to reach the endpoint.||percentage of participants|||Number
706908|NCT00117676|Secondary|Percentage of Participants With HBsAg Loss and/or Seroconversion to Anti-HBs at Week 96|HBsAg loss was defined as HBsAg positive at baseline and HBsAg negative at Week 96. Seroconversion to anti-HBs was defined as change of detectable antibody to HBsAg from negative at baseline to positive at Week 96.|Baseline; Week 96|Randomized and Treated Analysis Set. Data is included for participants who had discontinued unless the reason for discontinuation was unrelated to protocol criteria.||percentage of participants|||Number
706909|NCT00117676|Secondary|Percentage of Participants With Hepatitis B S-Antigen (HBsAg) Loss or Seroconversion Antibody to HBs (Anti-HBs) at Week 48|HBsAg loss was defined as HBsAg positive at baseline and HBsAg negative at Week 48. Seroconversion to anti-HBs was defined as change of detectable antibody to HBsAg from negative at baseline to positive at Week 48.|Baseline; Week 48|Participants in the Randomized and Treated Analysis Set were analyzed. The missing = failure approach was used.||percentage of participants|||Number
706910|NCT00117676|Secondary|Change From Week 48 in ALT at Weeks 96, 144, 192, 240, 288, 336, 384, 432, and 480||Week 48; Weeks 96, 144, 192, 240, 288, 336, 384, 432, and 480|Participants in the Randomized and Treated Analysis Set with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added FTC to their open-label TDF regimen were included in the analysis.||units per liter||Standard Deviation|Mean
706911|NCT00117676|Secondary|Change From Baseline in ALT at Weeks 48, 96, 144, 192, 240, 288, 336, 384, 432, and 480||Baseline; Weeks 48, 96, 144, 192, 240, 288, 336, 384, 432, and 480|Participants in the Randomized and Treated Analysis Set with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added FTC to their open-label TDF regimen were included in the analysis.||units per liter||Standard Deviation|Mean
706912|NCT00117676|Secondary|Percentage of Participants With ALT Normalization at Weeks 432 and 480|ALT normalization was defined as ALT > ULN at baseline and within the normal range at the subsequent time point. The ULN was 43 U/L for males and 34 U/L for females aged 18 to < 69, and 35 U/L for males and 32 U/L for females aged ≥ 69.|Baseline; Weeks 432 and 480|Participants in the Randomized and Treated Analysis Set with ALT > ULN at baseline and with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added FTC to their open-label TDF regimen were included in the analysis.||percentage of participants|||Number
706913|NCT00117676|Secondary|Percentage of Participants With ALT Normalization at Weeks 144, 192, 240, 288, 336, and 384|ALT normalization was defined as ALT > ULN at baseline and within the normal range at the subsequent time point. The ULN was 43 U/L for males and 34 U/L for females aged 18 to < 69, and 35 U/L for males and 32 U/L for females aged ≥ 69.|Baseline; Weeks 144, 192, 240, 288, 336, and 384|Participants in the Randomized and Treated Analysis Set with ALT > ULN at baseline and available data were analyzed. Data included for participants who had discontinued unless the reason for discontinuation was unrelated to protocol criteria; data for participants who added FTC to their open-label TDF regimen were included in the analysis.||percentage of participants|||Number
706914|NCT00117676|Secondary|Percentage of Participants With ALT Normalization at Weeks 96|ALT normalization was defined as ALT > ULN at baseline and within the normal range at Week 96. The ULN was 43 U/L for males and 34 U/L for females aged 18 to < 69, and 35 U/L for males and 32 U/L for females aged ≥ 69.|Baseline; Week 96|Participants in the Randomized and Treated Analysis Set with ALT > ULN at baseline. Data included for participants who had discontinued unless the reason for discontinuation was unrelated to protocol criteria; data for participants who added FTC to their open-label TDF regimen were included in the analysis.||percentage of participants|||Number
706941|NCT00117845|Secondary|Safety|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|72 months|||Participants|||Number
706915|NCT00117676|Secondary|Percentage of Participants With ALT Normalization at Week 48|ALT normalization was defined as ALT > upper limit of normal (ULN) at baseline and within the normal range at the end of blinded treatment. The ULN was 43 U/L for males and 34 U/L for females aged 18 to < 69, and 35 U/L for males and 32 U/L for females aged ≥ 69.|Baseline; Week 48|Participants in the Randomized and Treated Analysis Set with ALT > ULN at baseline were analyzed; the missing-equals-failure approach was used where participants with missing data were considered to have failed to reach the endpoint.||percentage of participants|||Number
706916|NCT00117676|Secondary|Ranked Assessment of Necroinflammation and Fibrosis at Week 240|Participants were ranked as having improvement, no change, worsening, or missing data (compared to Baseline) based on the Knodell scoring system, and results are presented as the percentage of participants in each category. The Knodell necroinflammatory score is the combined score for necrosis and inflammation domains of the Knodell scoring system, which ranges from 0 (best) to 14 (worst). The Knodell fibrosis domain score ranges from 0 (best) to 4 (worst). A decrease of 1 point or more indicated improvement, and an increase of 1 point or more indicated worsening.|Baseline; Week 240|Participants in the Randomized and Treated Analysis Set with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added FTC to their open-label TDF regimen were included in the analysis.||percentage of participants|||Number
706917|NCT00117676|Secondary|Ranked Assessment of Necroinflammation and Fibrosis at Week 48|Participants were ranked as having improvement, no change, worsening, or missing data (compared to Baseline) based on the Knodell scoring system, and results are presented as the percentage of participants in each category. The Knodell necroinflammatory score is the combined score for necrosis and inflammation domains of the Knodell scoring system, which ranges from 0 (best) to 14 (worst). The Knodell fibrosis domain score ranges from 0 (best) to 4 (worst). A decrease of 1 point or more indicated improvement, and an increase of 1 point or more indicated worsening.|Baseline; Week 48|Randomized and Treated Analysis Set; the missing-equals-failure approach was used where participants with missing data were considered to have failed to reach the endpoint.||percentage of participants|||Number
706918|NCT00117676|Secondary|Change From Baseline in Knodell and Ishak Necroinflammatory Scores at Week 240|The Knodell necroinflammatory score is the combined score for necrosis and inflammation domains of the Knodell scoring system, and ranges from 0 (best) to 14 (worst). The Ishak score measures the degree of liver fibrosis (scarring) caused by chronic necroinflammation (inflammation leading to cell death) and ranges from 0 (best) to 6 (worst).|Baseline; Week 240|Participants in the Randomized and Treated Analysis Set with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added FTC to their open-label TDF regimen were included in the analysis.||units on a scale||Standard Deviation|Mean
706919|NCT00117676|Secondary|Change From Baseline in Knodell and Ishak Necroinflammatory Scores at Week 48|The Knodell necroinflammatory score is the combined score for necrosis and inflammation domains of the Knodell scoring system, and ranges from 0 (best) to 14 (worst). The Ishak score measures the degree of liver fibrosis (scarring) caused by chronic necroinflammation (inflammation leading to cell death) and ranges from 0 (best) to 6 (worst).|Baseline; Week 48|Participants in the Randomized and Treated Analysis Set with measurements at Baseline and Week 48 were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis.||units on a scale||Standard Deviation|Mean
706920|NCT00117676|Secondary|Percentage of Participants With Histological Response at Week 240|Histological response was based on the Knodell numerical scoring of liver biopsy specimens and defined as at least a 2-point reduction in Knodell necroinflammatory score without worsening in Knodell fibrosis score. The Knodell necroinflammatory score is the combined necrosis and inflammation domain scores and ranges from 0 to 14; the Knodell fibrosis domain score ranges from 0 to 4.|Baseline; Week 240|Participants in the Randomized and Treated Analysis Set with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added FTC to their open-label TDF regimen were included in the analysis.||percentage of participants|||Number
706921|NCT00117676|Secondary|Percentage of Participants With Histological Response at Week 48|Histological response was based on the Knodell numerical scoring of liver biopsy specimens and defined as at least a 2-point reduction in Knodell necroinflammatory score without worsening in Knodell fibrosis score. The Knodell necroinflammatory score is the combined necrosis and inflammation domain scores and ranges from 0 to 14; the Knodell fibrosis domain score ranges from 0 to 4.|Baseline; Week 48|Randomized and Treated Analysis Set; the missing-equals-failure approach was used where participants with missing data were considered to have failed to reach the endpoint.||percentage of participants|||Number
706922|NCT00117676|Secondary|Change From Week 48 in HBV DNA at Weeks 96, 144, 192, 240, 288, 336, 384, 432, and 480||Week 48; Weeks 96, 144, 192, 240, 288, 336, 384, 432, and 480|Participants in the Randomized and Treated Analysis Set with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added FTC to their open-label TDF regimen were included in the analysis.||log10 copies/mL||Standard Deviation|Mean
706923|NCT00117676|Secondary|Change From Baseline in HBV DNA at Weeks 48, 96, 144, 192, 240, 288, 336, 384, 432, and 480||Baseline; Weeks 48, 96, 144, 192, 240, 288, 336, 384, 432, and 480|Participants in the Randomized and Treated Analysis Set with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added FTC to their open-label TDF regimen were included in the analysis.||log10 copies/mL||Standard Deviation|Mean
706924|NCT00117676|Secondary|Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 432 and 480||Weeks 432 and 480|Participants in the Randomized and Treated Analysis Set with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added emtricitabine to their open-label TDF regimen were included in the analysis.||percentage of participants|||Number
706925|NCT00117676|Secondary|Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 144, 192, 240, 288, 336, and 384||Weeks 144, 192, 240, 288, 336, and 384|Randomized and Treated Analysis Set. Data included for participants who had discontinued unless the reason for discontinuation was unrelated to protocol criteria. Participants with missing values related to protocol criteria or who added FTC to their open-label TDF regimen were considered to have failed to reach the endpoint.||percentage of participants|||Number
706928|NCT00117676|Primary|Percentage of Participants With HBV DNA < 400 Copies/mL and Histological Improvement (2-point Reduction in Knodell Necroinflammatory Score Without Worsening in Knodell Fibrosis Score) at Week 48|"Complete response was a composite endpoint defined as histological response and HBV DNA < 400 copies/mL. Histological response was based on the Knodell numerical scoring of liver biopsy specimens and defined as at least a 2-point reduction in Knodell necroinflammatory score without worsening in Knodell fibrosis score. The Knodell necroinflammatory score is the combined necrosis and inflammation domain scores and ranges from 0 to 14; the Knodell fibrosis domain score ranges from 0 to 4.
A participant was a nonresponder for the primary endpoint if either biopsy (baseline or end-of-treatment) was missing or if there was not an HBV DNA value available at or beyond Week 40."|Baseline; Week 48|Randomized and Treated Analysis Set: all participants who were randomized and received at least one dose of study medication; the missing-equals-failure approach was used where participants with missing data were considered to have failed to reach the endpoint.||percentage of participants|||Number
706929|NCT00117715|Primary|Change in CYP1A2 Drug Metabolism Phenotype With Age|Concentrations of caffeine metabolites 5-Acetylamino-6-amino-3-methyluracil (AAMU), 1-methylxanthine (1MX), 1-methyluric acid (1MU), and 1,7-dimethyluric acid (17MU) are quantified in urine and used to estimate the activity of cytochrome P450 1A2 using the well established (AAMU+1MX+1MU)/1,7U ratio. The longitudinal study design allows for changes in drug metabolism activity as a function of age which can be characterized via least squares regression where the slope of age vs. (AAMU+1MX+1MU)/1,7U ratio is examined for deviations from zero.|every 6 months for 5 years|Participants completing each milestone visit at each 0.5 years of age.||unitless ratio||Standard Deviation|Mean
706930|NCT00117715|Primary|Change in CYP3A4 Drug Metabolism Phenotype With Age|Concentrations of dextromethorphan (DM) metabolites 3-hydroxymorphinan (3HM) and dextrorphan (DX) are quantified in urine and used to estimate the activity of cytochrome P450 3A4 using the well established 3HM/DX ratio. The longitudinal study design allows for changes in drug metabolism activity as a function of age which can be characterized via least squares regression where the slope of age vs. 3HM/DX ratio is examined for deviations from zero.|every 6 months for 5 years|Participants completing each milestone visit at each 0.5 years of age.||unitless ratio||Standard Deviation|Mean
706931|NCT00117715|Primary|Change in CYP2D6 Drug Metabolism Phenotype With Age|Concentrations of dextromethorphan(DM) and it's metabolite dextrorphan (DX) are quantified in urine and used to estimate the activity of cytochromes P450 2D6 using the well established DM/DX ratio. The longitudinal study design allows for changes in drug metabolism activity as a function of age which can be characterized via least squares regression where the slope of age vs. DM/DX ratio is examined for deviations from zero.|every 6 months for 5 years|Participants completing each milestone visit at each 0.5 years of age.||unitless ratio||Standard Deviation|Mean
706932|NCT00117793|Secondary|Frustration (PEQ Scale)|Qualitative differences between the study limbs were assessed using the Prosthesis Evaluation Questionnaire (PEQ). This standardized, self-report instrument is specific to persons with lower limb amputations and is used to evaluate prosthetic care with regard to prescription and prosthesis-related quality of life. Frustration was assessed by frequency of occurrence and rating. The scale is scored from 0 to 100 where 100 indicates the best outcome (i.e., least frustrating).|Measurements were taken after wearing the study prosthesis for four weeks|The number of participants for analysis is equal to the number of participants who completed the study protocol.||units on a scale||Standard Deviation|Mean
706933|NCT00117793|Secondary|Ambulation (PEQ Scale)|Qualitative differences between the study limbs were assessed using the Prosthesis Evaluation Questionnaire (PEQ). This standardized, self-report instrument is specific to persons with lower limb amputations and is used to evaluate prosthetic care with regard to prescription and prosthesis-related quality of life. The Ambulation scale queries the ability to walk in general, in close spaces, on stairs and ramps, in urban environments, and on slippery surfaces. The scale is scored from 0 to 100 where 100 indicates the best outcome (i.e., easiest to walk on).|Measurements were taken after wearing the study prosthesis for four weeks|The number of participants for analysis is equal to the number of participants who completed the study protocol.||units on a scale||Standard Deviation|Mean
706934|NCT00117793|Secondary|Residual Limb Health (PEQ Scale)|Qualitative differences between the study limbs were assessed using the Prosthesis Evaluation Questionnaire (PEQ). This standardized, self-report instrument is specific to persons with lower limb amputations and is used to evaluate prosthetic care with regard to prescription and prosthesis-related quality of life. The Residual Limb Health scale examines: sweat, smell, volume changes, rashes, ingrown hairs, and blisters. The scale is scored from 0 to 100 where 100 indicates the best outcome (i.e., most healthful).|Measurements were taken after wearing the study prosthesis for four weeks|The number of participants for analysis is equal to the number of participants who completed the study protocol.||units on a scale||Standard Deviation|Mean
706935|NCT00117793|Primary|Limb Pistoning|Limb pistoning is the change in the resultant distance between the prosthetic-side knee joint marker triad and the residual limb thigh triad measured using a 12-camera motion analysis system while subjects weighted and un-weighted their prosthesis standing in place.|Measurements were taken after wearing the study prosthesis for three weeks|The number of participants for analysis is equal to the number of participants who completed the study protocol.||mm||Standard Deviation|Mean
706936|NCT00117793|Primary|Activity Level|Total number of steps during a two week period ending in the fourth week for each study prosthesis (PIN and VASS).|Two weeks|The number of participants for analysis is equal to the number of participants who completed the study protocol.||steps (in thousands)||Standard Deviation|Mean
706937|NCT00117793|Primary|Limb Volume||Measurements were taken after wearing the study prostheses for three weeks|The number of participants for analysis is equal to the number of participants who completed the study protocol.||liters||Standard Deviation|Mean
706938|NCT00117806|Primary|Competitive Employment-Percentage of Participants With Competitive Employment|Employment outcomes during year 1 among those subjects obtaining competitive employment.|12 months|||percentage of participants||95% Confidence Interval|Number
706939|NCT00117806|Primary|Competitive Employment-Participants With Competitive Employment|Competitive employment (a job in the community paying minimum wage ) during year 1 among those subjects obtaining employment.|12 months|||Participants with competitive employment|||Number
706940|NCT00117806|Primary|Competitive Employment-Total Jobs|Competitive employment (a job in the community paying minimum wage ) during year 1 among those subjects obtaining employment.|12 months|||Total Competitive Employments|||Number
706942|NCT00117845|Primary|Response Rate|Response rate is based on the number of patients who achieve either a complete response (CR) or partial response (PR) to therapy. Complete response is complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease related symptoms if present before therapy and normalization of those biochemical abnormalities (for example LDH) definitely assignable to the lymphoma. Partial response is reduction by >=50% of leukemia cell count or >=50% reduction is the size of all measurable lesions, and no increase in size of any measurable or evaluable lesion or appearance of new lesion.|up to 12 months|||Participants|||Number
706943|NCT00117949|Secondary|Liver Function Tests|The number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferas levels, and bilirubin levels plus the number of participants who had ALT increases >3x ULN and ALT increases >3x ULN with concurrently increased bilirubin >1.5 ULN.|3 months|||participants|||Number
706944|NCT00117949|Secondary|Time to 90% Reduction in Prostate-specific Antigen Levels|The time to 90% prostate-specific antigen (PSA) reduction from baseline was defined as the median number of days from dosing to the first visit where a 90% reduction in PSA level was reached.|3 months|Participants who did not achieve the actual level of reduction were censored as of the time from dosing for the last available observation. In the 40 mg group only one participant reached a 90% reduction in PSA and the Kaplan-Meier estimate could not be calculated (ie no statistical analysis is presented for this group).||days||Full Range|Median
706945|NCT00117949|Secondary|Time to 50% Reduction in Prostate-specific Antigen Levels|The time to 50% prostate-specific antigen (PSA) reduction from baseline was defined as the median number of days from dosing to the first visit where a 50% reduction in PSA level was reached.|3 months|Participants who did not achieve the actual level of reduction were censored as of the time from dosing for the last available observation. In the 40 mg group only two participants reached a 50% reduction in PSA and the Kaplan-Meier estimate could not be calculated (ie no statistical analysis is presented for this group).||days||Full Range|Median
706946|NCT00117949|Primary|Number of Participants With Testostestone Serum Levels Below 0.5 ng/mL for at Least 28 Days|"The number of participants suppressed for at least 28 days was defined as the estimated survival probability at time=Day 28."|28 days|||participants|||Number
706947|NCT00117949|Secondary|Number of Participants With Sufficient Testosterone Suppression for at Least 84 Days|Sufficient testosterone suppression was defined as not meeting an insufficient testosterone response criterion. Insufficient testosterone response was defined as testosterone >1.0 ng/mL at one visit or testosterone 0.5-1.0 at two consecutive visits.|3 months|||participants|||Number
706948|NCT00117949|Secondary|Time to Testosterone Castration (Testosterone ≤0.5 ng/mL).|Time to testosterone castration was calculated as the number of days from dosing to the first scheduled visit when testosterone was less than 0.5 ng/mL. The figures in the table present the number of participants who were castrated after 1, 3, 7, 14, 21, 28, and 42 days.|1, 3, 7, 14, 21, 28, 42 days|Half participants in the 40 mg group were not castrated and the median was not calculated (no statistical anaylsis was made). Two participants out of 24 in the 80 mg, 1/24 in the 120 mg, and 3/24 in the 160 mg groups were not castrated. For the 160 mg group the 95% CI was non-estimable and no statistical anaylsis was made.||days|||Number
706949|NCT00117949|Primary|Time to Meet Insufficient Testosterone Response|Figures in the table are Kaplan-Meier estimates of the time to meeting insufficient testosterone response. Insufficient testosterone response was defined as testosterone >1.0 ng/mL at one visit or testosterone 0.5-1.0 at two consecutive visits.|3 months|Patients who withdrew without meeting the insufficient testosterone (T) suppression criteria were censored as of the time for last available T measurement prior to discontinuation. For the 40 mg group the 95% confidence interval around the time estimate was non-estimable and no statistical analysis is presented (the estimate was 14 days).||days||Full Range|Median
706950|NCT00117962|Other Pre-specified|Overall Survival|Overall survival (OS) is defined as the time from patient randomization (arm assignment) to death from any cause. The median OS with 95% CI was estimated using the Kaplan-Meier method.|Time from randomization to death (up to 4 years)|||months||95% Confidence Interval|Median
706951|NCT00117962|Secondary|Number of Participants With Overall Tumor Response|"Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria:
Complete Response (CR): disappearance of all target lesions;
Partial Response (PR) 30% decrease in sum of longest diameter of target lesions;
Progressive Disease (PD): 20% increase in sum of longest diameter of target lesions;
Stable Disease (SD): small changes that do not meet above criteria.
Overall tumor response is the total number of CR and PRs."|Duration of study until progression (up to 4 years)|||participants|||Number
706952|NCT00117962|Secondary|Failure-free Survival|Failure-free survival (FFS) is the time from randomization to a failure event, defined as disease progression or death from any cause (which ever occurred first). The median FFS with 95% CI was estimated using the Kaplan-Meier method,|Time from randomization to failure (up to 4 years)|||months||95% Confidence Interval|Median
706953|NCT00117962|Primary|18 Month Survival|Percentage of participants who were alive at 18 months. The 18 month survival, with 95% CI, was estimated using the Kaplan-Meier method.|18 months (from randomization)|||percentage of participants||95% Confidence Interval|Number
706954|NCT00117988|Primary|Number of Patients With Response|Number of participants who experience complete response or partial response. Partial Response=>50% decrease in lympho node masses. Complete Response=>-75% decrease in lymph node masses.|Baseline to time to best response; Every 6 weeks|Analysis was intention to treat (ITT). All participants with baseline and at least one post baseline target lesion measurement were included.||participants|||Number
706955|NCT00118040|Secondary|pMAP Kinase in Tumor Tissue|"Detecting the signal of the biomarker, pMAP Kinase, in the tumor tissue after being on study drug for between 14-21 days.
Strong, Moderate, Weak, and Negative are categorized based on the signal. The measurements display the strength of the signal between the different Arms."|up to 21 days on Study Drug|For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV. Also for Arm III although 14 participants successfully completed the study for this group they were able to analyzed 15 for this outcome.||percentage of pMAP Kinase strength signa|||Number
706986|NCT00118157|Primary|Tumor Response Rate (Complete and Partial) Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)||4 weeks|||participants||95% Confidence Interval|Number
710942|NCT00168844|Secondary|Change From Baseline in Red Blood Cell Count|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||10^12/Litre (L)||Standard Deviation|Mean
706956|NCT00118040|Secondary|MAP Kinase in Tumor Tissue|"Detecting the signal of the biomarker, MAP Kinase, in the tumor tissue after being on study drug for between 14-21 days.
Strong, Moderate, Weak, and Negative are categorized based on the signal. The measurements display the strength of the signal between the different Arms."|up to 21 days on Study Drug|For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV. Also for Arm III although 14 participants successfully completed the study for this group they were able to analyzed 15 for this outcome.||percentage of MAP Kinase strength signal|||Number
706957|NCT00118040|Secondary|pAKT in Tumor Tissue|"Detecting the signal of the biomarker, pAKT, in the tumor tissue after being on study drug for between 14-21 days.
Strong, Moderate, Weak, and Negative are categorized based on the signal. The measurements display the strength of the signal between the different Arms."|up to 21 days on Study Drug|For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV. Also for Arm III although 14 participants successfully completed the study for this group they were able to analyzed 15 for this outcome.||percentage of pAKT strength signal|||Number
706958|NCT00118040|Secondary|AKT in Tumor Tissue|"Detecting the signal of the biomarker, AKT, in the tumor tissue after being on study drug for between 14-21 days.
Strong, Moderate, Weak, and Negative are categorized based on the signal. The measurements display the strength of the signal between the different Arms."|up to 21 days on Study Drug|For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV. Also for Arm III although 14 participants successfully completed the study for this group they were able to analyzed 15 for this outcome.||percentage of AKT strength signal|||Number
706959|NCT00118040|Secondary|COX2 in Tumor Tissue|"Detecting the signal of the biomarker, COX2, in the tumor tissue after being on study drug for between 14-21 days as a way to measuring the effects G-2535 have on it with regards to proliferation, apoptosis, and other processes relevant to bladder cancer.
Strong, Moderate, Weak, and Negative are categorized based on the signal. The measurements display the strength of the signal between the different Arms."|up to 21 days on Study Drug|For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV. Also for Arm III although 14 participants successfully completed the study for this group they were able to analyzed 15 for this outcome.||percentage of COX2 strength signal|||Number
706960|NCT00118040|Secondary|Activated Caspase 3 in Tumor Tissue|"Detecting the signal of the biomarker, Activated Caspase 3, in the tumor tissue after being on study drug for between 14-21 days as a way to measuring the effects G-2535 have on it with regards to proliferation, apoptosis, and other processes relevant to bladder cancer.
Strong, Moderate, Weak, and Negative are categorized based on the signal. The measurements display the strength of the signal between the different Arms."|up to 21 days on Study Drug|For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV. Also for Arm III although 14 participants successfully completed the study for this group they were able to analyzed 15 for this outcome.||percentage of Caspase 3 strength signal|||Number
706961|NCT00118040|Secondary|Ki-67 in Tumor Tissue|"Detecting the signal of the biomarker, Ki-67, in the tumor tissue after being on study drug for between 14-21 days as a way to measuring the effects G-2535 have on it with regards to proliferation, apoptosis, and other processes relevant to bladder cancer.
Strong, Moderate, Weak, and Negative are categorized based on the signal. The measurements display the strength of the signal between the different Arms."|up to 21 days on Study Drug|For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV. Also for Arm III although 14 participants successfully completed the study for this group they were able to analyzed 15 for this outcome.||percentage of Ki-67 strength signal|||Number
706962|NCT00118040|Secondary|EGFR in Benign Tissue|"Detecting the signal of the biomarker, EGFR, in the benign tissue after being on study drug for between 14-21 days.
Strong, Moderate, Weak, and Negative are categorized based on the signal. The measurements display the strength of the signal between the different Arms."|up to 21 days on Study Drug|For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV.||percentage of EGFR strength signal|||Number
706963|NCT00118040|Primary|pEGFR in Benign Tissue|"Detecting the signal of the biomarker, pEGFR, in the benign tissue after being on study drug for between 14-21 days.
Strong, Moderate, Weak, and Negative are categorized based on the signal. The measurements display the strength of the signal between the different Arms."|up to 21 days on Study Drug|For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV.||percentage of pEGFR strength signal|||Number
706964|NCT00118040|Secondary|EGFR Mutations in Tumor Tissue|"Detecting the signal of EGFR mutations in the tumor tissue after being on study drug for between 14-21 days.
Strong, Moderate, Weak, and Negative are categorized based on the signal. The measurements display the strength of the signal between the different Arms."|up to 21 days on Study Drug|For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV. Also for Arm III although 14 participants successfully completed the study for this group they were able to analyzed 15 for this outcome.||percentage of EGFR strength signal|||Number
706965|NCT00118040|Secondary|Survivin in Tumor Tissue|"Detecting the signal of the biomarker, Survivin, in the tumor tissue after being on study drug for between 14-21 days.
Strong, Moderate, Weak, and Negative are categorized based on the signal. The measurements display the strength of the signal between the different Arms."|up to 21 days on Study Drug|For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV. Also for Arm III although 14 participants successfully completed the study for this group they were able to analyzed 15 for this outcome.||percentage of Survivin strength signal|||Number
706966|NCT00118040|Secondary|Survivin in Urine by Visit (pg/ml)|Detecting the mean amount of the biomarker Survivin in the urine of patients prior to starting study agent, at Day 8 and pre-surgery time (when they have been on study agent between 14-21 days). This is measured by urine analysis at each of the time points to serve as a surrogate tumor marker.|up to 21 days|For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV. Also for Arm III although 14 participants successfully completed the study for this group they were able to analyzed 16 for this outcome.||pg/ml||Standard Deviation|Mean
706967|NCT00118040|Secondary|BLCA-4 in Urine by Visit|Detecting the mean amount of the biomarker BLCA-4 in the urine of patients prior to starting study agent, at Day 8 and pre-surgery time (when they have been on study agent between 14-21 days). This is measured by urine analysis at each of the time points to serve as a surrogate tumor marker.|up to 21 days|For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV. Also for Arm III although 14 participants successfully completed the study for this group they were able to analyzed 17 for this outcome.||pg/ml||Standard Deviation|Mean
706968|NCT00118040|Primary|Epidermal Growth Factor Receptor (EGFR) Phosphorylation in Tumor Tissue, as Measured by Immunohistochemistry After the Completion of Treatment|Strong, Moderate, Weak, and Negative are categorized based on the signal. The measurements display the strength of the signal between the different Arms.|up to 21 days|For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV. Also for Arm III although 14 participants successfully completed the study for this group they were able to analyzed 15 for this outcome.||percentage of pEGFR strength signal|||Number
706969|NCT00118053|Secondary|Pathologic and Molecular Markers for Predicting Efficacy||5 years|Study was terminated early and insufficient data were collected to evaluate this outcome measure.|||||
706970|NCT00118053|Secondary|Disease-free Survival||10 years|Study was terminated early and insufficient data were collected to evaluate this outcome measure.|||||
706971|NCT00118053|Secondary|Pathological Complete Response||5 years|Study was terminated early and insufficient data were collected to evaluate this outcome measure.|||||
706972|NCT00118053|Primary|Antitumor Activity as Measured by Response Rate||5 years|Study was terminated early and insufficient data were collected to evaluate this outcome measure.|||||
706973|NCT00118092|Secondary|Duration of PSA Response and PSA Control|"The distribution of this response duration will be estimated using the method of Kaplan-Meier. In patients whose PSA has declined from baseline by at least 30 %, “duration of PSA response” will be defined as the time from PSA response to time of progression. If a patient goes on to alternate therapy, they will be censored at the date they end treatment on this study. “Duration of PSA Control” is defined as the time from the date of the first 30% decline in PSA until an inflection point is identified. Inflection point is defined as the time to first consistent PSA increase, the point at which PSA began what becomes a continuous increase
> (retrospectively identified). The inflection point is the point at which disease control could assume to be lost."|From PSA response to time of progression, assessed up to 1 year|No participants with PSA response or PSA control.|||||
706974|NCT00118092|Secondary|Disease-free Survival|Disease-free survival time is defined as the time from registration to documentation of disease progression. If a patient dies without a documentation of disease progression, the patient will be considered to have had progressed at the time of their death. In patients who have achieved a PSA response, we will assess the time to PSA progression. If the patient is declared to be a major treatment violation, the patient will be censored on the date the treatment violation was declared to have occurred. In the case of a patient starting treatment and then never returning for any evaluations, the patient will be censored for progression on day 1 post-registration. The distribution of disease-free survival time will be estimated using the method of Kaplan-Meier.|From registration to documentation of disease progression, assessed up to 3 years|All 15 eligible patients that started treatment were evaluated.||months||95% Confidence Interval|Median
706975|NCT00118092|Secondary|Overall Survival|Overall survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.|From registration to death due to any cause, assessed up to 3 years|All 15 eligible patients that started treatment were evaluated.||months||95% Confidence Interval|Median
706976|NCT00118092|Secondary|Proportion of Overall Responses|"Confirmed response rate was defined using Response Evaluation Criteria In Solid Tumors (RECIST). A confirmed response is defined as a complete response (CR) or partial response (PR) observed on subsequent scans at least 4 weeks apart. Confirmed response rate was estimated by the number of successes divided by the total number of evaluable patients. Complete Response (CR) is defined as the disappearance of all target lesions. Partial Response (PR) is defined as a 30% decrease in sum of longest diameter of target lesions.
The proportion of confirmed responses will be estimated by the number of patients with confirmed responses divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner."|Up to 3 years|All 15 eligible patients that started treatment were evaluated.||percentage of responses||95% Confidence Interval|Number
706977|NCT00118092|Primary|PSA Response as Defined by the Recommendations of the Prostate-Specific Antigen Working Group|"Normalization: PSA ≤4.0 ng/ml. This must be confirmed by a second PSA value measured when patient returns in 4-6 weeks. This qualifies as a CR response. > > 50% decline: A 50% decline in PSA value from baseline which must be confirmed by a second PSA value measured when patient returns in 4-6 weeks later. This qualifies as a PR response. >
> Progression: A 25% or greater increase over baseline and an increase in the PSA level by at least 5 ng/mL, which is confirmed by a second value obtained approximately one week later. In addition, radiographic scans are required to confirm that a disease progression is by PSA only."|Up to 1 year|All 15 eligible patients that started treatment were evaluated.||participants|||Number
706978|NCT00118131|Secondary|Median Survival Time||10 years|Analysis was performed on the first 47 patients only as it was too early to collect data for the last 2 patients.||months||95% Confidence Interval|Median
706979|NCT00118131|Secondary|1-year Survival Rate||8 years|Analysis was performed on the first 47 patients only as it was too early to collect data for the last 2 patients.||1-year survival rate (percentage)|||Number
706980|NCT00118131|Secondary|Time to Progressive Disease||8 years|Analysis was performed on the first 47 patients only as it was too early to collect data for the last 2 patients.||months||95% Confidence Interval|Median
706981|NCT00118131|Primary|Overall Tumor Response Rate|Patients experiencing complete or partial response|7 years|Analysis was performed on the first 47 patients only as it was too early to collect data for the last 2 patients.||Response rate (percentage)|||Number
706982|NCT00118144|Secondary|Overall Survival|Overall Suvival using the product-limit method of Kaplan and Meier.|Up to 5 years|||Months||95% Confidence Interval|Mean
706983|NCT00118144|Secondary|Progression-free Survival|Progression Free Survival using the product-limit method of Kaplan and Meier|Up to 5 years|||Months||95% Confidence Interval|Median
706984|NCT00118144|Primary|Objective Response Rate With Bortezomib Evaluated by Both RECIST Criteria and Computer-assisted Image Analysis.|A response rate of 20% or more with bortezomib would be of interest for further evaluation, whereas a response rate of less than 5% would be of no interest. Response defined as a confirmed CR or PR.|Up to 5 years|||percentage of responders|||Number
706985|NCT00118157|Secondary|Changes in Phosphorylation in Tumor Tissue of Epidermal Growth Factor Receptor (EGFR), HER2, AKT Kinase, MAPK, ER-Ser118, and ER-SER167||Baseline and at 21 days||||||
706987|NCT00118248|Secondary|Toxicity|Defined as the number of participants reporting grade 3 or higher adverse events that are classified as either possibly, probably, or definitely related to study treatment. Determined using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|Every 3 courses during treatment (median cycle number was 5 with a maximum of 38 cycles)|All participants were evaluable for this endpoint.||participants|||Number
706988|NCT00118248|Secondary|Overall Survival|Defined as the time from registration to date of last follow-up or death due to any cause. Estimated using the Kaplan-Meier method.|Every 3 months until progression, and then every 6 months up to 3 years|All patients were evaluable for this endpoint.||years||95% Confidence Interval|Median
706989|NCT00118248|Secondary|Progression-Free Survival|Defined as the time from registration to the date of progression or death due to any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Patients that are not classified as having a progression are termed progression-free. Estimated using the Kaplan-Meier method.|Every 3 months for up to 3 years|All participants were evaluable for this endpoint.||months||95% Confidence Interval|Median
706990|NCT00118248|Secondary|Overall Response|"The number of responses were categorized and summarized independently within each of the patient groups. Participants were evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.0.
Complete Response (CR): Disappearance of all lesions.
Partial Response (PR): At least a 30% decrease in the sum of the longest dimension (LD) of target lesions taking as reference the baseline sum LD."|Baseline, every 3 courses, and at the end of treatment study|All participants were evaluated for response.||participants|||Number
706991|NCT00118248|Primary|Proportion of Patients Who Have Remained on Treatment and Progression-free at Least One Year After Start of 17-AAG (Tanespimycin)|"The one-year treatment failure free rate is 100% times the proportion of eligible patients who remain on treatment and are progression-free at least one year after treatment start. A 90% confidence interval for the one year treatment failure free rate was constructed using the properties of the binomial confidence interval.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Patients that are not classified as having a progression are termed progression-free."|1 year|All patients were evaluable for this endpoint in this group.||percentage of participants||90% Confidence Interval|Number
706992|NCT00118287|Primary|Frequency of Hematologic Responses, as Defined by International Working Group (IWG) Criteria|Count of participants with a hematologic improvement (erythroid, platelet, or neutrophil response), assessed at 3 months.|Up to 2 years|||Participants|||Count of Participants
706993|NCT00118352|Secondary|Disease Progression/Relapse|"CML New cytogenetic abnormality and/or development of accelerated phase or blast crisis. The criteria for accelerated phase will be defined as unexplained fever greater than 38.3°C, new clonal cytogenetic abnormalities in addition to a single Ph-positive chromosome, marrow blasts and promyelocytes >20%.
AML, ALL >5% marrow blasts by morphologic or flow cytometric, or appearance of extramedullary disease.
CLL ≥1 of: Physical exam/Imaging studies (nodes, liver, and/or spleen) ≥50% increase or new, circulating lymphocytes by morphology and/or flow cytometry ≥50% increase, and lymph node biopsy w/ Richter’s transformation.
NHL >25% increase in the sum of the products of the perpendicular diameters of marker lesions, or the appearance of new lesions.
MM
≥100% increase of the serum myeloma protein from its lowest level, or reappearance of myeloma peaks that had disappeared w/ treatment; or definite increase in the size or number of plasmacytomas or lytic bone lesions."|Up to 5 years|||percentage of participants|||Number
706994|NCT00118352|Secondary|Immune Reconstitution|The outcome of immune reconstitution was not analyzed by the collaborating laboratory because only a small number of patients were only enrolled in Dose Level 1 (no alemtuzumab). The Dose Level 1 patients were going to be the baseline for which to compare the other patients on Dose Level 2 (and 3) who would have received alemtuzumab. The collaborating investigator determined that the study was not worthwhile performing based on this information.|Up to 1 year post-transplant||||||
706995|NCT00118352|Secondary|Incidence of Infection|Percentage patients that experienced infection(s).|Up to 5 years post-transplant|||percentage of participants|||Number
706996|NCT00118352|Secondary|Incidence of Non-relapse Mortality|Percentage patient deaths due to non-relapse mortality|100 days after transplant|||percentage of participants|||Number
706997|NCT00118352|Secondary|Incidence of High-dose Corticosteroid Utilization.|Percentage patients requiring steroids greater than 1 mg/kg.|100 days after transplant|||percentage of participants|||Number
706998|NCT00118352|Secondary|Incidence of Graft Rejection|Percentage patients that experienced graft rejection.|84 days after transplant|||percentage of participants|||Number
706999|NCT00118352|Primary|Incidence of Grade III-IV Acute GVHD|"Severity of Individual Organ Involvement
Liver:
Stage 2 - bilirubin (3-5.9mg/100ml) Stage 3 - bilirubin (6-14.9mg/100ml) Stage 4 - bilirubin > 15mg/100ml
Gut:
Diarrhea is graded stage 1 to stage 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as stage 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall
Severity of GVHD
Grade III - Stage 2 to 4 gastrointestinal involvement and/or Stage 2 to 4 liver involvement with or without a rash Grade IV - Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death"|100 days after transplant|||percentage of participants|||Number
707000|NCT00118365|Secondary|Biomarker in Adenoma: Bcl-2|bcl-2 is the anti-apoptotic protein BCL2|At the end of the study, up to 3 years|The analysis cohort is based on the participants whose data are available.||Adenoma|Participants||Number
707001|NCT00118365|Secondary|Biomarker in Adenoma - p53|"Estimated mean percent of cells staining postivie for p53 based on GEE approach with adjument for covariates.
Tumor protein p53, also known as p53, cellular tumor antigen p53, phosphoprotein p53, or tumor suppressor p53, is a protein that in humans is encoded by the TP53 gene."|At the end of the study|The analysis cohort is based on the participants whose data are available.||percentage of cells that are positive||95% Confidence Interval|Mean
707002|NCT00118365|Secondary|Biomarker in Adenoma: Sialyl-TN (B72.3)|sialyl-Tn (B72.3) is adenocarcinoma tissue marker that is expressed during adenoma formation.|At the end of the study|The analysis cohort is based on the participants whose data are available.||Adenoma|Participants||Number
707004|NCT00118365|Secondary|Biomarker in Adenoma - Ki-67|Estimated mean percent of cells staining postivie for the Ki-67 based on the GEE approach with adjustment for covariates|At the end of the study|The analysis cohort is based on the participants whose data are available.||percentage of cells that are positive||95% Confidence Interval|Mean
707005|NCT00118365|Secondary|Biomarker in Adenoma: Apoptosis|Apoptosis expression was assessed using cytoplasmic staining. The definitions for the category level for the Apoptosis are: 1. focal (less than 10% cells that are positively stained); 2. less than 50% cells are positively stained; 3. more than 50% cells are positively stained.|At the end of the study|The analysis cohort is based on the participants whose data are available.||adenoma|Participants||Number
707006|NCT00118365|Secondary|Number of Participants Have Adenoma Recurrence in Each ODC1 Genotytpe by Treatment Group|ODC genotype is the genotype of single nucleotide polymorphisms (SNP) in the ornithine decarboxylase (ODC) promoter The analysis cohort is based on the participants whose data are available and complete.|Up to 36 months|The analysis cohort is based on the participants whose data are available and complete.||participants|||Number
707007|NCT00118365|Secondary|At the End of the Study - Spermine Response by ODC Genotype|"Spermine responder was defined as (tissue spermine value at baseline - tissue spermine value at the end of the study)/(tissue spermine value at baseline) ≥ the threshold. Spermine non-responder was defined as (tissue spermine value at baseline - tissue spermine value at the end of the study)/(tissue spermine value at baseline) < the threshold. The thresholds range from 0.25 to 0.45 with an increment of 0.5. The below data are shown for the threshold of 0.30.
ODC genotype is the genotype of single nucleotide polymorphisms (SNP) in the ornithine decarboxylase (ODC) promoter The analysis cohort is based on the participants whose data are available and complete."|At the end of the study|The analysis cohort is based on the participants whose data are available and complete.||participants|||Number
707008|NCT00118365|Secondary|At the End of the Study - Spermidine Response by ODC Genotype|"Spermidine responder was defined as (tissue spermidine value at baseline - tissue spermidine value at the end of the study)/(tissue spermidine value at baseline) ≥ the threshold. Spermidine non-responder was defined as (tissue spermidine value at baseline - tissue spermidine value at the end of the study)/(tissue spermidine value at baseline) < the threshold. The thresholds range from 0.25 to 0.45 with an increment of 0.5. The below data are shown for the threshold of 0.30.
ODC genotype is the genotype of single nucleotide polymorphisms (SNP) in the ornithine decarboxylase (ODC) promoter The analysis cohort is based on the participants whose data are available and complete."|At the end of the study|The analysis cohort is based on the participants whose data are available and complete.||participants|||Number
707009|NCT00118365|Secondary|At the End of the Study - Putrescine Response by ODC Genotype|"Putrescine responder was defined as (tissue putrescine value at baseline - tissue putrescine value at the end of the study)/(tissue putrescine value at baseline) ≥ the threshold. Putrescine non-responder was defined as (tissue putrescine value at baseline - tissue putrescine value at the end of the study)/(tissue putrescine value at baseline) < the threshold. The thresholds range from 0.25 to 0.45 with an increment of 0.5. The below data are shown for the threshold of 0.30.
ODC genotype is the genotype of single nucleotide polymorphisms (SNP) in the ornithine decarboxylase (ODC) promoter The analysis cohort is based on the participants whose data are available and complete."|At the end of the study|The analysis cohort is based on the participants whose data are available and complete.||participants|||Number
707010|NCT00118365|Secondary|Baseline Spermine by ODC Genotype|ODC genotype is the genotype of single nucleotide polymorphisms (SNP) in the ornithine decarboxylase (ODC) promoter The analysis cohort is based on the participants whose data are available and complete.|Baseline|The analysis cohort is based on the participants whose data are available and complete.||nmol/mg protein||Full Range|Median
707011|NCT00118365|Secondary|Baseline Spermidine by ODC Genotype|ODC genotype is the genotype of single nucleotide polymorphisms (SNP) in the ornithine decarboxylase (ODC) promoter The analysis cohort is based on the participants whose data are available and complete.|Baseline|The analysis cohort is based on the participants whose data are available and complete.||nmol/mg protein||Full Range|Median
707012|NCT00118365|Secondary|Baseline Putrescine by ODC Genotype|ODC genotype is the genotype of single nucleotide polymorphisms (SNP) in the ornithine decarboxylase (ODC) promoter The analysis cohort is based on the participants whose data are available and complete.|Baseline|The analysis cohort is based on the participants whose data are available and complete.||nmol/mg protein||Full Range|Median
707013|NCT00118365|Secondary|Adverse Events With a Grade of 3 and Above|"Participants reported at least 1 adverse event with a grade of 3 and above, regardless if the event is defined as serious per protocol or other.
Per protocol, not all grade 3 events are considered as serious events."|Up to 36 months|||participants|||Number
707014|NCT00118365|Secondary|Detection of Any Adenoma at the End of the Study Stratified by Spermidine-to-spermine Ratio Response and Treatment|Spermidine-to-spermine ratio responder = ratios at 36-month are decreased by >=30% from baseline Spermidine-to-spermine ratio nonresponder = ratios at 36-month are increased, or decreased by < 30% from baseline The analysis cohort is based on the participants whose data are available and complete.|Up to 36 months|The analysis cohort is based on the participants whose data are available and complete.||participants|||Number
707015|NCT00118365|Secondary|Detection of Any Adenoma at the End of the Study Stratified by Putrescine Response and Treatment|Putrescine responder = Putrescine values at 36-month are decreased by >=30% from baseline Putrescine nonresponder = Putrescine values at 36-month are increased, or decreased by < 30% from baseline The analysis cohort is based on the participants whose data are available and complete.|Up to 36 months|The analysis cohort is based on the participants whose data are available and complete.||participants|||Number
707016|NCT00118365|Secondary|Detection of Any Adenoma at the End of the Study Stratified by Prostaglandin E2 (PGE2) Response and Treatment|PGE2 Responder = PGE2 values at 36-month are decreased by >=30% in PGE2 values from baseline PGE2 nonresponder = PGE2 values at 36-month are increased, or decreased by < 30% from baseline The analysis cohort is based on the participants whose data are available and complete.|Up to 36 months|The analysis cohort is based on the participants whose data are available and complete.||participants|||Number
707061|NCT00118534|Secondary|7-day Point Prevalence Abstinence - Self Reported|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.|6 months|||participants||95% Confidence Interval|Number
707017|NCT00118365|Secondary|Detection of Any Adenoma at the End of the Study Stratified by Baseline Spermidine-to-spermine Ratio and Treatment|"The low is defined as the ratios that are below the median spermidine-to-spermine ratio in the analysis cohort. The high is defined as the ratios that are above the median spermidine-to-spermine ratio in the analysis cohort.
In the finalized datasaet, the total number of adnoma detected in the placebo group is 55. The descrepancy in the total number of adnoma detected in placebo group between Outcome Measure 1 and this oucome is due to the revolution of the datatset.
The analysis cohort is based on the participants whose data are available and complete."|Up 36 months|In the finalized datasaet, the total number of adnoma detected in the placebo group is 55. The descrepancy in the total number of adnoma detected in placebo group between Outcome Measure 1 and this oucome is due to the revolution of the datatset. The analysis cohort is based on the participants whose data are available and complete.||participants|||Number
707018|NCT00118365|Secondary|Detection of Any Adenoma at the End of the Study Stratified by Baseline Putrescine and Treatment|The low is defined as the values that are below the median putrescine level in the analysis cohort. The high is defined as the values that are above the median putrescine level in the analysis cohort.|Up 36 months|In the finalized datasaet, the total number of adnoma detected in the placebo group is 55. The descrepancy in the total number of adnoma detected in placebo group between Outcome Measure 1 and this oucome is due to the revolution of the datatset. The analysis cohort is based on the participants whose data are available and complete.||participants|||Number
707019|NCT00118365|Secondary|Detection of Any Adenoma at the End of the Study Stratified by Baseline Prostaglandin E2 (PGE2) and Treatment|This analysis is based on the participants who had the end-of-study colonscopy procedure done and their baseline PGE2 values are available. The low PGE2 is defined as the values that are below the median PGE2 value in the analysis cohort. The high PGE2 is defined as the values that are above the median PGE2 value in the analysis cohort.|Up to 36 months|This analysis is based on the participants who had the end-of-study colonscopy procedure done and their baseline PGE2 values are available. The low PGE2 is defined as the values that are below the median PGE2 value in the analysis cohort. The high PGE2 is defined as the values that are above the median PGE2 value in the analysis cohort.||participants|||Number
707020|NCT00118365|Primary|Detection of Any Adenoma at the End of the Study|Detection of any adenoma at the end of the study. This analysis is based on the participants who had the end-of-study colonscopy procedure done.|Up to 36 months|This analysis is based on the participants who had the end-of-study colonscopy procedure done.||participants|||Number
707021|NCT00118378|Secondary|HIV RNA Viral Load|"HIV RNA viral load assay is a laboratory measure indicating viral activity. Because of the large range of possible values (50-100,000 copies), this measure is presented in log10. We entered the log10 value of 1.69 when the laboratory result stated under 50 copies, which was the assay's lowest limit of detectability during the study."|Measured at baseline and Week 4|Results were included for patients on whom baseline and week 4 labs were drawn.||Log10 copies/mL||Standard Deviation|Mean
707022|NCT00118378|Secondary|CD4 Cell Count|CD4 cell count is a laboratory marker providing an indication of immune functioning. Blood was drawn for this measure at baseline and week 4. The reference range for CD4 cell count is 490-1740, and a clinically significant change is defined as a change of >= 100 cells. A higher number is associated with better immune functioning.|Measured at baseline and Week 4|Results were included for patients on whom baseline and week 4 labs were drawn.||Cells/mcL||Standard Deviation|Mean
707023|NCT00118378|Primary|Role Function Scale Outcome|The Role Function Scale includes 10 items drawn from the Short Form 36-item Health Survey (SF-36) and other SF versions. It is intended to assess the extent to which fatigue has a behavioral impact on daily activities. Scores of frequency in the past week, on a 5-point scale, are summed with higher scores signifying greater role impairment. Scores range from 10 to 50.|Measured at baseline and Week 4|The WEEK 4 outcome analyses are based on an intention to treat sample which includes the 10 dropouts (2 on Modafinil and 8 on Placebo), using the last data point brought forward.||units on a scale||Standard Deviation|Mean
707024|NCT00118378|Primary|Fatigue Severity Scale (FSS)|The FSS is a 9-item self-report scale that measures the impact of fatigue on everyday functioning. Each item is rated on a scale of 1 to 7. Total scores range from 9 to 63, with a higher value indicating greater impairment due to fatigue.|Measured at baseline and Week 4|The WEEK 4 outcome analyses are based on an intention to treat sample which includes the 10 dropouts (2 on Modafinil and 8 on Placebo), using the last data point brought forward.||units on a scale||Standard Deviation|Mean
707025|NCT00118404|Primary|Depressive Relapse/Recurrence or MDD|"Longitudinal Interval Follow-up Evaluation - Psychiatric Status Rating (LIFE-PSR) of 5 or more (on a scale from 1 to 6 measuring MDD) for 2 consecutive weeks according to evaluator blinded to randomized assignment
LIFE-PSR Scale:
= No residual symptoms, no current evidence of the disorder.
= Mild symptoms
= Considerably less psychopathology than full criteria with no more than moderate impairment
= Does not meet full criteria but has major symptoms of impairment
= Meets criteria without extreme impairment in functioning
= Meets criteria with extreme impairment in functioning
Relapse/recurrence rate was estimated using Kaplan-Meier estimates (Kaplan, Meier J Am Stat, 1958, pp.457-481)."|Measured at month 32|Intention to treat analysis||% patients who relapsed/recurred|||Number
707026|NCT00118404|Primary|Depressive Relapse/Recurrence or MDD|"Longitudinal Interval Follow-up Evaluation - Psychiatric Status Rating (LIFE-PSR) of 5 or more (on a scale from 1 to 6 measuring MDD) for 2 consecutive weeks according to evaluator blinded to randomized assignment
LIFE-PSR Scale:
= No residual symptoms, no current evidence of the disorder.
= Mild symptoms
= Considerably less psychopathology than full criteria with no more than moderate impairment
= Does not meet full criteria but has major symptoms of impairment
= Meets criteria without extreme impairment in functioning
= Meets criteria with extreme impairment in functioning
Relapse/recurrence rate was estimated using Kaplan-Meier estimates (Kaplan, Meier J Am Stat, 1958, pp.457-481)"|Measured at month 20|Intention to treat analysis||% patients who relapsed/recurred|||Number
707062|NCT00118534|Secondary|7-day Point Prevalence Abstinence - Self Reported|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.|3 months|||participants||95% Confidence Interval|Number
708765|NCT00144170|Secondary|Virologic Response at Week 72|Virologic response defined as Viral Load<400 copies/mL|Week 72|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
707027|NCT00118404|Primary|Depressive Relapse or MDD|"Longitudinal Interval Follow-up Evaluation - Psychiatric Status Rating (LIFE-PSR) of 5 or more (on a scale from 1 to 6 measuring major depressive disorder) for 2 consecutive weeks according to evaluator blinded to randomized assignment
LIFE-PSR Scale:
= No residual symptoms, no current evidence of the disorder.
= Mild symptoms
= Considerably less psychopathology than full criteria with no more than moderate impairment
= Does not meet full criteria but has major symptoms of impairment
= Meets criteria without extreme impairment in functioning
= Meets criteria with extreme impairment in functioning
The relapse rate was estimated using Kaplan-Meier estimates (Kaplan, Meier J Am Stat, 1958, pp.457-481)"|Measured at month 8|Intention to treat analysis||% patients who relapsed|||Number
707028|NCT00118417|Primary|Change in Panic Disorder Symptoms, Phase 3 (Week 12 - Week 24)|This measure is the change in points between baseline and endpoint scores on the Panic Disorder Severity Scale (PDSS). The PDSS is a 7-item scale with each item rated from 0 (none) to 4 (extreme), for a total score range of 0 to 28 points, and an established interrater reliability of 0.87.|Measured after Phase 2 (Week 12) and Phase 3 (Week 24)|||Points on a scale||Standard Deviation|Mean
707029|NCT00118417|Primary|Change in Panic Disorder Symptoms, Phase 2 (Week 6 - Week 12)|This measure is the change in points between baseline and endpoint scores on the Panic Disorder Severity Scale (PDSS). The PDSS is a 7-item scale with each item rated from 0 (none) to 4 (extreme), for a total score range of 0 to 28 points, and an established interrater reliability of 0.87.|Measured after Phase 1 (Week 6) and Phase 2 (Week 12)|||Points on a scale||Standard Deviation|Mean
707030|NCT00118417|Primary|Change in Panic Disorder Symptoms, Phase 1 (Week 0 - Week 6)|This measure is the change in points between baseline and endpoint scores on the Panic Disorder Severity Scale (PDSS). The PDSS is a 7-item scale with each item rated from 0 (none) to 4 (extreme), for a total score range of 0 to 28 points, and an established interrater reliability of 0.87.|Measured at baseline and after Phase 1 (6 weeks)|Analyses in each study phase were for a modified intent to treat (ITT) sample, defined as all participants who had at least one on-treatment assessment during that phase.||Points on a scale||Standard Deviation|Mean
707031|NCT00118430|Secondary|Primary Care Visits||Measured at Year 1|The no treatment group did not have depression and was followed simply as a cohort and not part of the clinical trial. Therefore we did not measure this secondary outcome of primary care visits in the no treatment group.||number of primary care visits||Standard Deviation|Mean
707032|NCT00118430|Secondary|Graded Chronic Pain Scale Disability Score|This scale ranges from 0 (no pain-specific disability) to 100 (highest or worst pain-specific disability)|Measured at Year 1|||units on a scale||Standard Deviation|Mean
707033|NCT00118430|Primary|HSCL-20 Depression Severity|This scale consists of 20 items, each scored from 0 (lowest) to 4 (highest or worst). The scale score is the average of the 20 items. Therefore, the HSCL-20 depression severity score can range from 0 (no depression) to 4 (highest or worst depression)|Measured at Year 1|||units on a scale||Standard Deviation|Mean
707034|NCT00118430|Primary|Brief Pain Inventory Interference|The BPI interference scale consists of 7 items, each scored from 0 (no interference) to 10 (complete interference), and the total score is the average of the 7 individual item scores. Therefore, the BPI interference score can range from 0 (lowest pain) to 10 (worst or highest pain).|Measured at Year 1|||units on a scale||Standard Deviation|Mean
707035|NCT00118482|Secondary|Quality of Life Will be the Third Secondary Outcome Measure. The Investigators Will Compare the Quality of Life in Treated and Untreated Patients.|Quality of life will be the third secondary outcome measure. The investigators will compare the quality of life in patients on fludrocortisone vs placebo|12 months||||||
707036|NCT00118482|Secondary|Presyncope Frequency, Duration, and Intensity Will be the Second Secondary Outcome Measures, Both Alone and in a Composite Score.||Within 12 months||||||
707037|NCT00118482|Secondary|The Frequency of Syncope Will be the First Secondary Outcome Measure.|Frequency will be reported as 12- month syncope event rates (%)|Within 12 months|||rate %||95% Confidence Interval|Mean
707038|NCT00118482|Primary|The Primary Outcome Measure Will be the Recurrence of Syncope in Follow up Period.|This will be measured in terms of number of patients that had at least 1 syncopal spell in the 12 month follow up period.|Within 12 months|||Participants|||Count of Participants
707039|NCT00118534|Secondary|30-day Point Prevalence Abstinence – Bio-Verified|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.|18 months|||participants||95% Confidence Interval|Number
707040|NCT00118534|Secondary|30-day Point Prevalence Abstinence – Bio-Verified|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.|15 months|||participants||95% Confidence Interval|Number
707063|NCT00118534|Secondary|Patient Health Questionnaire-9 (PHQ-9)|The Patient Health Questionnaire 9 (PHQ-9; range, 0-27; scores of 10-14, 15-19, and greater than or equal to 20 indicate mild, moderate, and severe depression,respectively) measured depression at every assessment. The results are reported as the mean change from baseline for the 18 month assessment.|Baseline and 18 months|||units on a scale||95% Confidence Interval|Mean
707405|NCT00122460|Secondary|Safety - Number of Patients Experiencing Any Adverse Event|Please refer to Adverse Events section for further details|time from first dose up to 30 after last dose of study treatment, reported between day of first dose of study treatment, 22 Dec 2004, until cut-off date 12 Mar 2007|Safety population||participants|||Number
707041|NCT00118534|Secondary|30-day Point Prevalence Abstinence – Bio-Verified|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.|12 months|||participants||95% Confidence Interval|Number
707042|NCT00118534|Secondary|30-day Point Prevalence Abstinence – Bio-Verified|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.|9 months|||participants||95% Confidence Interval|Number
707043|NCT00118534|Secondary|30-day Point Prevalence Abstinence – Bio-Verified|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.|6 months|||participants||95% Confidence Interval|Number
707044|NCT00118534|Secondary|30-day Point Prevalence Abstinence – Bio-Verified|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.|3 months|||participants||95% Confidence Interval|Number
707045|NCT00118534|Secondary|30-day Point Prevalence Abstinence – Self Reported|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.|18 months|||participants||95% Confidence Interval|Number
707046|NCT00118534|Secondary|30-day Point Prevalence Abstinence – Self Reported|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.|15 months|||participants||95% Confidence Interval|Number
707047|NCT00118534|Secondary|30-day Point Prevalence Abstinence – Self Reported|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.|12 months|||participants||95% Confidence Interval|Number
707048|NCT00118534|Secondary|30-day Point Prevalence Abstinence – Self Reported|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.|9 months|||participants||95% Confidence Interval|Number
707049|NCT00118534|Secondary|30-day Point Prevalence Abstinence – Self Reported|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.|6 months|||participants||95% Confidence Interval|Number
707050|NCT00118534|Secondary|30-day Point Prevalence Abstinence – Self Reported|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.|3 months|||participants||95% Confidence Interval|Number
707064|NCT00118534|Secondary|Patient Health Questionnaire (PHQ-9)|The Patient Health Questionnaire 9 (PHQ-9; range, 0-27; scores of 10-14, 15-19, and greater than or equal to 20 indicate mild, moderate, and severe depression,respectively) measured depression at every assessment. The results are reported as the mean change from baseline for the 15 month assessment.|Baseline and 15 months|||units on a scale||95% Confidence Interval|Mean
707065|NCT00118534|Secondary|Patient Health Questionnaire-9 (PHQ-9)|The Patient Health Questionnaire 9 (PHQ-9; range, 0-27; scores of 10-14, 15-19, and greater than or equal to 20 indicate mild, moderate, and severe depression,respectively) measured depression at every assessment. The results are reported as the mean change from baseline for the 12 month assessment.|Baseline and 12 months|||units on a scale||95% Confidence Interval|Mean
707051|NCT00118534|Secondary|7-day Point Prevalence Abstinence – Bio-Verified|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.|18 months|||participants||95% Confidence Interval|Number
707052|NCT00118534|Secondary|7-day Point Prevalence Abstinence – Bio-Verified|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.|15 months|||participants||95% Confidence Interval|Number
707053|NCT00118534|Secondary|7-day Point Prevalence Abstinence – Bio-Verified|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.|12 months|||participants||95% Confidence Interval|Number
707054|NCT00118534|Secondary|7-day Point Prevalence Abstinence – Bio-Verified|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.|9 months|||participants||95% Confidence Interval|Number
707055|NCT00118534|Secondary|7-day Point Prevalence Abstinence – Bio-Verified|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.|6 months|||participants||95% Confidence Interval|Number
707056|NCT00118534|Secondary|7-day Point Prevalence Abstinence – Bio-Verified|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.|3 months|||participants||95% Confidence Interval|Number
707057|NCT00118534|Secondary|7-day Point Prevalence Abstinence - Self Reported|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.|18 months|||participants||95% Confidence Interval|Number
707058|NCT00118534|Secondary|7-day Point Prevalence Abstinence - Self Reported|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.|15 months|||participants||95% Confidence Interval|Number
707059|NCT00118534|Secondary|7-day Point Prevalence Abstinence - Self Reported|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.|12 months|||participants||90% Confidence Interval|Number
707060|NCT00118534|Secondary|7-day Point Prevalence Abstinence - Self Reported|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.|9 months|||participants||95% Confidence Interval|Number
707066|NCT00118534|Secondary|Patient Health Questionnaire-9 (PHQ-9)|The Patient Health Questionnaire 9 (PHQ-9; range, 0-27; scores of 10-14, 15-19, and greater than or equal to 20 indicate mild, moderate, and severe depression,respectively) measured depression at every assessment. The results are reported as the mean change from baseline for the 9 month assessment.|Baseline and 9 months|||units on a scale||95% Confidence Interval|Mean
707067|NCT00118534|Secondary|Patient Health Questionnaire-9 (PHQ-9)|The Patient Health Questionnaire 9 (PHQ-9; range, 0-27; scores of 10-14, 15-19, and greater than or equal to 20 indicate mild, moderate, and severe depression,respectively) measured depression at every assessment. The results are reported as the mean change from baseline for the 6 month assessment.|Baseline and 6 months|||units on a scale||95% Confidence Interval|Mean
707068|NCT00118534|Secondary|Patient Health Questionnaire-9 (PHQ-9)|The Patient Health Questionnaire 9 (PHQ-9; range, 0-27; scores of 10-14, 15-19, and greater than or equal to 20 indicate mild, moderate, and severe depression,respectively) measured depression at every assessment. The results are reported as the mean change from baseline for the 3 month assessment.|Baseline and 3 months|||units on a scale||95% Confidence Interval|Mean
707069|NCT00118534|Secondary|PTSD Checklist|Severity of PTSD was a predetermined secondary outcome. One of the measurements for this was PTSD Checklist (range, 17-85; scores of greater or equal to 50 indicate a PTSD diagnosis) at every assessment. The results are reported as the mean change from baseline for the 18 month assessment.|Baseline and 18 months|||units on a scale||95% Confidence Interval|Mean
707070|NCT00118534|Secondary|PTSD Checklist|Severity of PTSD was a predetermined secondary outcome. One of the measurements for this was PTSD Checklist (range, 17-85; scores of greater or equal to 50 indicate a PTSD diagnosis) at every assessment. The results are reported as the mean change from baseline for the 15 month assessment.|Baseline and 15 months|||units on a scale||95% Confidence Interval|Mean
707071|NCT00118534|Secondary|PTSD Checklist|Severity of PTSD was a predetermined secondary outcome. One of the measurements for this was PTSD Checklist (range, 17-85; scores of greater or equal to 50 indicate a PTSD diagnosis) at every assessment. The results are reported as the mean change from baseline for the 12 month assessment.|Baseline and 12 months|||units on a scale||95% Confidence Interval|Mean
707072|NCT00118534|Secondary|PTSD Checklist|Severity of PTSD was a predetermined secondary outcome. One of the measurements for this was PTSD Checklist (range, 17-85; scores of greater or equal to 50 indicate a PTSD diagnosis) at every assessment. The results are reported as the mean change from baseline for the 9 month assessment.|Baseline and 9 months|||units on a scale||95% Confidence Interval|Mean
707073|NCT00118534|Secondary|PTSD Checklist|Severity of PTSD was a predetermined secondary outcome. One of the measurements for this was PTSD Checklist (range, 17-85; scores of greater or equal to 50 indicate a PTSD diagnosis) at every assessment. The results are reported as the mean change from baseline for the 6 month assessment.|Baseline and 6 months|||units on a scale||95% Confidence Interval|Mean
707074|NCT00118534|Secondary|PTSD Checklist|Severity of PTSD was a predetermined secondary outcome. One of the measurements for this was PTSD Checklist (range, 17-85; scores of greater or equal to 50 indicate a PTSD diagnosis) at every assessment. The results are reported as the mean change from baseline for the 3 month assessment.|Baseline and 3 months|||units on a scale||95% Confidence Interval|Mean
707075|NCT00118534|Secondary|Clinician Administered PTSD Scale (CAPS)|"Severity of PTSD was a predetermined secondary outcome. One of the measurements for this was CAPS at 18 months. The range is 0-136; five rationally derived severity score ranges for interpreting CAPS total score have been proposed and are as follows: 0-19 = asymptomatic/few symptoms, 20-39 = mild PTSD/subthreshold, 40-59 = moderate PTSD/threshold, 60-79 = severe PTSD symptomatology, and >80 = extreme PTSD symptomology. A rationally derived 15-point change in CAPS total severity score has been proposed as a marker of clinically significant change. The above severity ranges and 15-point marker are preliminary (Frank W. Weathers et. al., Clinician-administered PTSD Scale: A Review of the First Ten Years of Research, Depression and Anxiety 13: 132-156 (2001)). The results are reported in mean change from baseline."|Baseline and 18 months|||Units on a scale||95% Confidence Interval|Mean
707076|NCT00118534|Secondary|Self-reported 12-month Prolonged Abstinence Between 6 and 18 Months|A secondary outcome was self-reported 1-year prolonged abstinence between 6 and 18 months post-randomization. Prolonged abstinence excluded tobacco use prior to 6 months post-randomization to allow for initial treatment episode completion and recovery from early relapses. Prolonged abstinence defined non-abstinence as: 1) smoking for 7 consecutive days or at least once a week for 2 consecutive weeks, or 2) using non-cigarette tobacco for 7 consecutive days or at least once a week for 2 consecutive weeks.|between 6 and 18 months|||participants|||Number
707077|NCT00118534|Primary|Bioverified 12-Month Prolonged Abstinence Between 6 and 18 Months Postrandomization|The primary outcome measure was 12-month bio-verified prolonged abstinence from tobacco between 6 and 18 months postrandomization. Prolonged abstinence excluded tobacco use before 6 months postrandomization. Prolonged abstinence defined non-abstinence as 1) smoking for 7 consecutive days or at least once a week for 2 consecutive weeks, or 2) using non-cigarette tobacco for 7 consecutive days or at least once a week for 2 consecutive weeks. Self-reported prolonged abstinence was verified by exhaled CO ≤ 8ppm and urine cotinine <100 ng/mL cotinine equivalents at the 9-18 month visits. If CO or cotinine was missing, a single measure was used for verification. If both CO and cotinine were missing at any visit between 9 and 15 months, patients reporting prolonged abstinence were considered abstinent if all other available bioverification data confirmed abstinence. Patients who lacked CO and cotinine readings at 18 months or failed to attend the 18 month visit were considered nonabstinent.|between 6 and 18 months|||participants|||Number
707078|NCT00118703|Secondary|Number of Participants Based on Overall Evaluation of Response to Therapy|Participants were evaluated effectiveness of study medication for relieving non-allergic rhinitis symptoms over the entire treatment period. The overall evaluation of response to therapy was based on a 7-point categorical scale (1-7) where the participants rate their perception of the change or lack of change in their VMR symptoms at the end of the study. The 7 categories were: 1: significantly improved, 2: moderately improved, 3: mildly improved, 4: no change, 5: mildly worse, 6: moderately worse and 7: significantly worse. Effectiveness of study medication for relieving VMR symptoms over the entire treatment period.|Week 4 (Day 29) or Early Withdrawal|ITT Population. Only participants available at the specified time point were analyzed.||Participants|||Number
710943|NCT00168844|Secondary|Change From Baseline in Haemoglobin|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||grams per litre (g/L)||Standard Deviation|Mean
707079|NCT00118703|Secondary|Mean Change From Baseline in Morning (AM) Pre-dose Instantaneous Total Nasal Symptom Scores (iTNSS)|The morning pre-dose iTNSS was the sum of the individual symptom score for rhinorrhoea, nasal congestion and postnasal drip performed immediately prior to taking the daily dose which were scored on a scale of 0-3 (total score 0-9). The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. The Baseline daily iTNSS was defined as the average of the daily iTNSS over the 4 consecutive 24-hour periods prior to randomization, including the assessment on the morning of randomization. Change from Baseline was calculated as the on-treatment value minus the Baseline value.|Baseline and up to Week 4|ITT population. Only participants available at the specified timepoint were analyzed.||Score on a scale||Standard Error|Least Squares Mean
707080|NCT00118703|Primary|Mean Change From Baseline in Daily Reflective Total Nasal Symptom Scores (rTNSS)|The TNSS was the sum of the individual symptom scores for rhinorrhoea, nasal congestion and post-nasal drip which was scored on a scale of 0-3 (total score 0-9). The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. The rTNSS was a rating of the severity of symptoms over the previous 12 hours and was performed in the morning (AM rTNSS) and evening (post meridian [PM] rTNSS). The daily rTNSS was the sum of two assessments. The Baseline daily rTNSS was defined as the average of the daily rTNSS over the 4 consecutive 24-hour periods prior to randomization, including the assessment on the morning of randomization. Change from Baseline was calculated as the on-treatment value minus the Baseline.|Baseline and up to Week 4|Intent-to-Treat (ITT) population comprised of all participants who were randomized and received at least one dose of study drug. Only participants present at the specified time point were analyzed.||Score on a scale||Standard Error|Least Squares Mean
707081|NCT00118742|Secondary|Change From Baseline in Creatinine Clearance|Mean percent change from baseline in calculated creatinine clearance (CL) at 6, 12, and 24 months posttransplantation|6, 12, and 24 months posttransplantation|intent-to-treat population||Percent change in creatinine CL (mL/min)||Standard Deviation|Mean
707082|NCT00118742|Secondary|Change From Baseline in Glomerular Filtration Rate (GFR) at 24 Months Posttransplant|Mean percent change from baseline in estimated GFR calculated by modification of diet in renal disease (MDRD)-6 variable equation at 6 and 24 months posttransplantation. MDRD-6 variables: serum creatinine, albumin and urea nitrogen, gender, age and ethnicity.|24 months posttransplant|intent-to-treat population||Mean percent change in GFR (mL/min)||Standard Deviation|Mean
707083|NCT00118742|Secondary|Change From Baseline in Glomerular Filtration Rate (GFR) at 6 Months Posttransplant|Mean percent change from baseline in estimated GFR calculated by modification of diet in renal disease (MDRD)-6 variable equation at 6 and 24 months posttransplantation. MDRD-6 variables: serum creatinine, albumin and urea nitrogen, gender, age and ethnicity.|6 months posttransplant|intent-to-treat population||Percent change in GFR (mL/min)||Standard Deviation|Mean
707084|NCT00118742|Primary|Change From Baseline in Glomerular Filtration Rate (GFR) at 12 Months Posttransplant|Mean percent change from baseline in estimated glomerular filtration rate (GFR) calculated by modification of diet in renal disease (MDRD)-6 variable equation at 12 months posttransplantation. MDRD-6 variables: serum creatinine, albumin and urea nitrogen, gender, age and ethnicity.|12 months posttransplant|intent-to-treat population||Percent change in GFR (mL/min)||Standard Deviation|Mean
707085|NCT00118755|Secondary|Duration of Overall Clinical Response (CR or PR)|Among tumor responders (i.e., patients with overall best response of CR or PR), duration of overall response was measured from the time criteria were first met for CR or PR (whichever status was recorded first) to the date of either recurrent/progressive disease was objectively documented or death from any cause.|Time to Disease Progression or Death (through follow-up phase): Approximate Median of 302 days|Intent-to-treat population||Days to event||95% Confidence Interval|Median
707086|NCT00118755|Secondary|Best Overall Clinical Response|"Overall response rate was assessed according to RECIST (the best response recorded from the time of randomization to the first CR or PR. The patient’s overall best response was complete response (CR), partial response (PR) (CR and PR considered responders), stable disease (SD), or progressive disease (PD). To be assigned a status of complete response (CR) or partial response (PR), changes in tumor measurements were confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met."|Through follow-up phase: Approximate Median of 318 days|Intent-to-treat population||Patients|||Number
707087|NCT00118755|Secondary|Overall Survival|Overall survival was defined as the time from the date of randomization to the date of death, for any cause.|Time to death (through follow-up phase): Approximate Median of 718 days|Intent-to-treat population||Days||95% Confidence Interval|Median
707088|NCT00118755|Primary|Progression-free Survival (PFS)|Progression-free survival was defined as the time from the date of randomization to the first occurrence of having documented disease progression or death due to any cause, whichever comes first. Progression was based on tumor assessments made by the investigators according to Response Evaluation Criteria in Solid Tumors (RECIST).|Time to disease progression or death (through follow-up phase)|Intent-to-treat population||Days||95% Confidence Interval|Median
707089|NCT00118898|Secondary|Change in Fasting Triglyceride Level From Baseline|Only fasting results are included. The protocol did not require that samples be collected fasting.|At Weeks 48 and 96|Intention to treat: All participants with fasting lipids data were included, complete-case approach.||mg/dL||Inter-Quartile Range|Median
707090|NCT00118898|Other Pre-specified|Cumulative Probability of Not Experiencing Regimen Failure|Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. Treatment modification was defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution.|At week 48 and 96|Participants who initiated treatment are included in this analysis. Participants were analyzed per originally assigned regimen.||percentage of participants||95% Confidence Interval|Number
707091|NCT00118898|Other Pre-specified|Number of Participants With Regimen Failure|Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. Treatment modification was defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution.|Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details|Participants who initiated treatment are included in this analysis. Participants were analyzed per originally assigned regimen.||participants|||Number
707092|NCT00118898|Other Pre-specified|Cumulative Probability of Not Experiencing Treatment Modification|Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Treatment modification is defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution.|At week 48 and 96|Participants who initiated treatment are included in this analysis. Participants were analyzed per originally assigned regimen.||percentage of participants||95% Confidence Interval|Number
707093|NCT00118898|Other Pre-specified|Number of Participants With Treatment Modification|Treatment modification is defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution.|Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details|Participants who initiated treatment are included in this analysis. Participants were analyzed per originally assigned regimen.||participants|||Number
707094|NCT00118898|Other Pre-specified|Cumulative Probability of Not Experiencing a Grade 3/4 Safety Event|Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Grade 3/4 safety event is defined as a grade 3 or 4 sign, symptom, or laboratory abnormality that is at least one grade higher than at baseline, total bilirubin and creatine kinase (CPK) were excluded. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables. As-treated analysis censored at 1st modification of initially assigned regimen, participants who never started treatment were excluded.|At week 48 and 96|As-treated: Participants who initiated treatment are included in this analysis. Follow-up while on initially assigned treatment is included in the at-risk period.||percentage of participants||95% Confidence Interval|Number
707095|NCT00118898|Other Pre-specified|Number of Participants With a Grade 3/4 Safety Event|Grade 3/4 safety event is defined as a grade 3 or 4 sign, symptom, or laboratory abnormality that is at least one grade higher than at baseline, total bilirubin and creatine kinase (CPK) were excluded. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables. As-treated analysis censored at 1st modification of initially assigned regimen, participants who never started treatment were excluded.|Over all study follow-up while on initially assigned treatment, median follow-up was 120 weeks|As-treated: Participants who initiated treatment are included in this analysis. Follow-up while on initially assigned treatment is included in the at-risk period.||participants|||Number
707096|NCT00118898|Primary|Time From Treatment Dispensation to Treatment Modification|Treatment modification is defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution.|Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details|Participants who initiated treatment are included in this analysis. Participants were analyzed per originally assigned regimen.||Weeks||95% Confidence Interval|Number
707097|NCT00118898|Other Pre-specified|Cumulative Probability of Not Experiencing Virologic Failure|Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks.|At week 48 and 96|Intention to treat: All eligible participants were included in the analysis, participants were analyzed per originally assigned regimen.||percentage of participants||95% Confidence Interval|Number
707098|NCT00118898|Primary|Time From Treatment Dispensation to a Grade 3/4 Safety Event|Grade 3/4 safety event is defined as a grade 3 or 4 sign, symptom, or laboratory abnormality that is at least one grade higher than at baseline, total bilirubin and creatine kinase (CPK) were excluded. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables.|All follow-up while on initially assigned regimen; the median (25th, 75th percentile) follow-up while on initial regimen was 120 (54, 156) weeks and the range was 0 to 205 weeks.|As-treated: Participants who initiated treatment are included in this analysis. Follow-up while on initially assigned treatment is included in the at-risk period.||Weeks||95% Confidence Interval|Number
707099|NCT00118898|Secondary|Change in Fasting Non-high Density Lipoprotein (Non-HDL) Cholesterol Level From Baseline|Only fasting results are included. The protocol did not require that samples be collected fasting.|At Weeks 48 and 96|Intention to treat: All participants with fasting lipids data were included, complete-case approach.||mg/dL||Inter-Quartile Range|Median
707100|NCT00118898|Secondary|Change in Fasting High-density Lipoprotein (HDL) Cholesterol Level From Baseline|Only fasting results are included. The protocol did not require that samples be collected fasting.|At Weeks 48 and 96|Intention to treat: All participants with fasting lipids data were included, complete-case approach.||mg/dL||Inter-Quartile Range|Median
707101|NCT00118898|Secondary|Change in Fasting Total Cholesterol Level From Baseline|Only fasting results are included. The protocol did not require that samples be collected fasting.|At Weeks 48 and 96|Intention to treat: All participants with fasting lipids data were included, complete-case approach.||mg/dL||Inter-Quartile Range|Median
707102|NCT00118898|Secondary|Number of Participants Experiencing Certain Targeted Clinical Events, Including Death, AIDS-defining Illness, and HIV-1 Related Events.|"AIDS-defining illnesses were defined per CDC category C definition. HIV-1 related events were defined per CDC category B definition. Events underwent study chair review for classification. See link below for more details.
http://www.cdc.gov/mmwr/preview/mmwrhtml/00018871.htm"|Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details|Intention to treat: All eligible participants were included in the analysis, participants were analyzed per originally assigned regimen.||Participants|||Number
707216|NCT00121238|Secondary|Mean Time to Progression of Prostate Cancer|Kaplan-Meier estimates of time to progression will be reported.|Up to 5 years|Patients were eligible if they had a histologic or cytologic diagnosis of prostate cancer with no evidence of metastatic disease or local progression on radiologic imaging and had 3 consecutive rising levels of prostate specific antigen (psa). Eligible patients who were treated on this trial were analyzed for survival||months||95% Confidence Interval|Mean
707103|NCT00118898|Secondary|Number of Participants With Virologic Failure and Emergence of Major Resistance|Emergence of resistant virus was assessed by genotypic testing performed at Stanford University for all participants who met criteria for virologic failure and retrospectively on baseline samples from these participants. Major mutations were defined by International AIDS Society-United States of America (2008), as well as T69D, L74I, G190C/E/Q/T/V for reverse transcriptase and L24I, F53L, I54V/A/T/S, G73C/S/T/A, N88D for protease.|Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details|Intention to treat: All eligible participants are included. Participants were analyzed per originally assigned regimen.||participants|||Number
707104|NCT00118898|Secondary|Change in CD4 Count (Cells/mm3) From Baseline|Change was calculated as the CD4 count at Week 48 (or at Week 96) minus the baseline CD4 count (mean of pre-entry and entry values).|At Weeks 48 and 96|Intention to treat: All participants with CD4 data were included, complete-case approach.||Cells/mm3||Inter-Quartile Range|Median
707105|NCT00118898|Secondary|Number of Participants With HIV-1 RNA Levels Less Than 200 Copies/mL||At Weeks 48 and 96|Intention to treat: All participants with RNA data were included, complete-case approach.||Participants|||Number
707106|NCT00118898|Secondary|The Number of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL||At Weeks 48 and 96|Intention to treat: All participants with RNA data were included, complete-case approach.||Participants|||Number
707107|NCT00118898|Secondary|Time From Treatment Dispensation to Regimen Failure (First Occurrence of Virologic Failure or Treatment Modification)|Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. Treatment modification was defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution.|Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details|Participants who initiated treatment are included in this analysis. Participants were analyzed per originally assigned regimen.||Weeks||95% Confidence Interval|Number
707108|NCT00118898|Other Pre-specified|Number of Participants With Virologic Failure|Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks.|Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details|Intention to treat: All eligible participants were included in the analysis, participants were analyzed per originally assigned regimen.||participants|||Number
707109|NCT00118898|Other Pre-specified|Amount of Study Follow-up|Participants were to be followed for 96 weeks after the last enrollment. Accrual was expected to take 96 weeks, thus the planned follow-up time was 96 to 192 weeks, dependent on when in the study the participant enrolled. This outcome summarizes that total amount of actual follow-up in weeks from randomization to last contact.|Follow-up time was variable, median follow-up was 138 weeks|Intention to treat: All eligible participants are included. Participants were analyzed per originally assigned regimen.||Weeks||Inter-Quartile Range|Median
707110|NCT00118898|Primary|Time From Randomization to Virologic Failure|Blood samples for determining virologic failure were obtained at visit weeks 16 and 24 , and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks after randomization and before 24 weeks, or >=200 copies/mL at or after 24 weeks. The 5th percentile for time to virologic failure is the time (in weeks) at which 5% of the participants have experienced virologic failure.|Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details|Intention to treat: All eligible participants were included in the analysis, participants were analyzed per originally assigned regimen.||Weeks||95% Confidence Interval|Number
707111|NCT00118911|Secondary|Maintenance of Gains in CBT Condition|maintenance of gains in CBT condition for those who responded or partially responded as measured by the ADHD symptom severity as measured by the ADHD rating scale (DuPaul, et al., 1998) a scale that ranges from 0-54 with 0 indicating lower severity.|12 month follow-up (12 months after baseline assessment)|||units on a scale of symptom severity||Standard Deviation|Mean
707112|NCT00118911|Primary|Post-treatment ADHD Symptoms|ADHD symptom severity as measured by the ADHD rating scale (DuPaul, et al., 1998) a scale that ranges from 0-54 with 0 indicating lower severity.|post-treatment (after receiving 12 sessions of treatment)|Analysis was based on intent to treat. We used mixed-effect modeling which automatically imputes data using the slope up to the point of discontinuation.||units on a scale of symptom severity||Standard Deviation|Mean
707113|NCT00119015|Secondary|Change From Baseline in Other Symptom Score Over 2 Week Randomized Treatment Period|"Patients recorded the severity of other symptoms, including itchy nose/eyes and post-nasal drip, twice a day on a scale from 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe). The other symptom score was calculated as the sum of all scores for morning and evening recordings with a range of 0 to 6.
The baseline symptom score used in the analysis was the average of the symptom scores from the last 5 days of fluticasone propionate therapy prior to randomized treatment period.
The change from baseline for each subsequent day of treatment was then calculated for each subject. So that each subject only had one observation, the average of these changes was calculated for each subject, and this summary measure was used in the analysis comparing the two treatment groups. We report the median and full range of these average changes for each group.
A negative value indicates an improvement in symptoms."|Baseline and 2 weeks|||units on a scale||Full Range|Median
707114|NCT00119015|Secondary|Change From Baseline in Stuffy Nose Symptom Score Over 2 Week Randomized Treatment Period|"Patients recorded the severity of stuffy nose twice a day on a scale from 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe). The stuffy nose symptom score was calculated as the sum of all scores for morning and evening recordings with a range of 0 to 6.
The baseline symptom score used in the analysis was the average of the symptom scores from the last 5 days of fluticasone propionate therapy prior to randomized treatment period.
The change from baseline for each subsequent day of treatment was then calculated for each subject. So that each subject only had one observation, the average of these changes was calculated for each subject, and this summary measure was used in the analysis comparing the two treatment groups. We report the median and full range of these average changes for each group.
A negative value indicates an improvement in symptoms."|Baseline and 2 weeks|||units on a scale||Full Range|Median
707115|NCT00119015|Secondary|Change From Baseline in Runny Nose Symptom Score Over 2 Week Randomized Treatment Period|"Patients recorded the severity of runny nose twice a day on a scale from 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe). The runny nose symptom score was calculated as the sum of all scores for morning and evening recordings with a range of 0 to 6.
The baseline symptom score used in the analysis was the average of the symptom scores from the last 5 days of fluticasone propionate therapy prior to randomized treatment period.
The change from baseline for each subsequent day of treatment was then calculated for each subject. So that each subject only had one observation, the average of these changes was calculated for each subject, and this summary measure was used in the analysis comparing the two treatment groups. We report the median and full range of these average changes for each group.
A negative value indicates an improvement in symptoms."|Baseline and 2 weeks|||units on a scale||Full Range|Median
707116|NCT00119015|Secondary|Change From Baseline in Sneezing Symptom Score Over 2 Week Randomized Treatment Period|"Patients recorded the severity of sneezing twice a day on a scale from 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe). The sneezing symptom score was calculated as the sum of all scores for morning and evening recordings with a range of 0 to 6.
The baseline symptom score used in the analysis was the average of the symptom scores from the last 5 days of fluticasone propionate therapy prior to randomized treatment period.
The change from baseline for each subsequent day of treatment was then calculated for each subject. So that each subject only had one observation, the average of these changes was calculated for each subject, and this summary measure was used in the analysis comparing the two treatment groups. We report the median and full range of these average changes for each group.
A negative value indicates an improvement in symptoms."|Baseline and 2 weeks|||units on a scale||Full Range|Median
707117|NCT00119015|Primary|Change From Baseline in Total Nasal Symptom Score (TNSS) Over 2 Week Randomized Treatment Period|"Patients recorded the severity of sneezing, runny nose, stuffy nose, and other symptoms (itchy nose/eyes and post-nasal drip) twice a day on a scale from 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe). The TNSS was calculated as the sum of all scores for morning and evening recordings with a range of 0 to 24.
The baseline TNSS used in the analysis was the average of the symptom scores from the last 5 days of fluticasone propionate therapy prior to randomized treatment period.
The change from baseline for each subsequent day of treatment was then calculated for each subject. So that each subject only had one observation, the average of these changes was calculated for each subject, and this summary measure was used in the analysis comparing the two treatment groups. We report the median and full range of these average changes for each group.
A negative value indicates an improvement in symptoms."|Baseline and 2 weeks|||units on a scale||Full Range|Median
707118|NCT00119041|Primary|A1c|Hemoglobin A1c is a measure of glycemic control|baseline and 18 months|||percentage of Hb that is glycosylated||Full Range|Mean
707119|NCT00119041|Secondary|Patient Satisfaction|Diabetes Treatment Satisfaction Questionnaire (DTSQ) consists of 6 questions and ranges from 0-6. The following aspects of current treatment included were convenience, flexibility, understanding and continuing present form of treatment. The total range of the DTSQ is the sum of the 6 individual questions scores (i.e. 0-36) Higher scores represent greater satisfaction/convenience.|Base line and at18 months.|The number subjects was determined on the size of the CBOC.||units on a scale||Full Range|Mean
707120|NCT00119158|Secondary|Change From Baseline in Patients' Self Assessment of Disease Severity (PSA) of Target Areas|"The patient or caregiver assessment of eczema severity (PSA) was recorded daily in a diary using a 0–4 scale similar to that of the IGA.(0 = clear,
1 = almost clear, 2 = mild disease, 3 = moderate disease,4 = severe disease).
Difference in value of PSA from baseline to end of study"|30 days||||||
707121|NCT00119158|Secondary|The Percentage of Target Areas Reaching a m-EASI (Modifed-Eczema Area Severity Index) Score of 2 or Less|"The EASI is a measure of Atopic Dermatitis (AD) severity. A m-EASI score (0–12) was also calculated as the sum of severity (0 = mild to 3 = severe) for four separate AD symptoms: erythema, infiltration ⁄population, excoriation and lichenification.
The percentage of participants whose eczema reaches almost clear"|up to one week||||||
707122|NCT00119158|Secondary|The Percentage of Target Areas Improved (i.e., Decrease in Localized Investigator Global Assessmet (l-IGA) Score From Baseline)|"The percentage of eczema areas that show improvement in l-IGA score.
The l-IGA were graded on a scale of 0–4 (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease)."|up to 15 days||||||
707123|NCT00119158|Secondary|The Percentage of Target Areas Reaching a l-IGA (Localized Investigator Global Assessment (l-IGA) or 0 or 1)|The Investigator Global Assessment (IGA) and l-IGA were graded on a scale of 0–4 (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe). The percentage of eczema lesions from the total population that reach almost clear|up to 15 days||||||
707124|NCT00119158|Secondary|The Time to the First Day When m-EASI is Scored by the Investigator as 2 or Less|Time to partial clearance of the localized eczema lesion assessed by the investigator is measured in days|up to one week||||||
707125|NCT00119158|Secondary|The Time to Clearance of the Disease|The time to clearance of eczema measured in days|assessed up to 30 days following drug application|||days||Standard Error|Mean
707126|NCT00119158|Primary|Change From Baseline in the m-EASI (Eczema Area Severity Index) Score.|"Eczema Area severity index (EASI) is a composition of scores based on area of eczema involved, (0 = mild to 3 = severe) for four separate Atopic Dermatitis (AD) symptoms: erythema,infiltration ⁄population, excoriation and ichenification.
Total score 0-12"|up to 15 days|Analysis was per protocol, last observation carried forward||units of a 0-12 scale||Standard Deviation|Mean
707127|NCT00119262|Secondary|Proportion of Patients With Absolute Decrease in LVEF Levels Post Bevacizumab|The endpoint was measured by absolute decrease from baseline in LVEF of >15% or >10% decline from baseline to below the LLN post bevacizumab (the end of treatment). 158 patients who were treated and had baseline and end of treatment LVEF values were included in the analysis.|assessed on day 1 of cycles 5, 9, 17, 25, and at end of treatment|||percentage of participants||95% Confidence Interval|Number
707128|NCT00119262|Secondary|Proportion of Patients With Absolute Decrease in Left Ventricular Ejection Fraction (LVEF) Levels Post Doxorubicin and Cyclophosphamide(AC)|The endpoint was measured by absolute decrease from baseline in LVEF of >15% or >10% decline from baseline to below the LLN post doxorubicin and cyclophosphamide (AC) Day 1 Cycle 5 (DIC5). 207 patients who were treated and had baseline and DIC5 LVEF values were included in the analysis.|assessed on day 1 of cycles 5, 9, 17, 25, and at end of treatment|Patients who were treated and had baseline and DIC5 LVEF values||percentage of participants||95% Confidence Interval|Number
707129|NCT00119262|Primary|Congestive Heart Failure Rate|Clinical congestive heart failure includes patients with symptomatic decline in LVEF to at or below the lower limit of normal (LLN), or symptomatic diastolic dysfunction. 223 treated patients were included in the analysis.|assessed on day 1 of cycles 5, 9, 17 and 25, and at end of treatment, then every 3 months for <2 years and every 6 months for 2-3 years from study entry|223 treated patients||percentage of participants||95% Confidence Interval|Number
707130|NCT00119379|Secondary|Change in Hip Bone Mineral Density (BMD)|Change in hip bone mineral density (BMD) as measured by dual-energy x-ray absorbtiometry (DEXA) scan|Baseline to Week 48|||hip BMD, g/cm^2||Inter-Quartile Range|Median
707131|NCT00119379|Secondary|Change in Lumbar Spine Bone Mineral Density (BMD)|Change in lumbar spine bone mineral density (BMD) as measured by dual-energy x-ray absorbtiometry (DEXA) scan|Baseline to Week 48|||lumbar spine BMD, g/cm^2||Inter-Quartile Range|Median
707132|NCT00119379|Secondary|Change in Trunk Fat|Change in trunk fat as measured by dual-energy x-ray absorbtiometry (DEXA) scan|Baseline to Week 48|||trunk fat (kg)||Inter-Quartile Range|Median
707133|NCT00119379|Secondary|Change in Limb Fat|Change in limb fat as measured by dual-energy x-ray absorbtiometry (DEXA) scan|Baseline to Week 48|||limb fat (kg)||Inter-Quartile Range|Median
707134|NCT00119379|Primary|Change in PBMC mtDNA|Peripheral blood mononuclear cell (PBMC) mitochondrial DNA (mtDNA), measured in copies/cell|Baseline to Week 48|||copies/cell||Inter-Quartile Range|Median
707135|NCT00119379|Primary|Change in Fat mtDNA Content|Subcutaneous abdominal fat mitochondrial DNA (mtDNA)|Baseline to Week 48|||copies/cell||Inter-Quartile Range|Median
707136|NCT00119392|Secondary|Incidence and Severity of Acute Graft-versus-host Disease (GVHD) and Chronic GVHD.||At day +84|||Participants|||Count of Participants
707137|NCT00119392|Secondary|Engraftment and Hematopoietic Toxicity|Median number of days after transplantation to a neutrophil count less than 500 neutrophils per microliter and a platelet count less than 50,000 platelets per microliter.|At day +100|||days||Full Range|Median
707138|NCT00119392|Secondary|Response Rates||Up to 8 years|||Participants|||Count of Participants
707139|NCT00119392|Secondary|Overall and Progression-free Survival|Kaplan-Meier estimates for overall survival (OS) and progression free survival (PFS) assessed at two years.|Up to 8 years|||percent||95% Confidence Interval|Number
707140|NCT00119392|Primary|Treatment Related Mortality (TRM)|Cumulative incidence rate of treatment related mortality with relapse as a competing risk, assessed at 30 months.|At day +100|||percent||95% Confidence Interval|Number
707141|NCT00119405|Primary|Mitochondrial Function (mtDNA Levels)|Mitochondrial gene expression: mtDNA levels are used to quantify this outcome measure.|96 weeks|||copies per cell||95% Confidence Interval|Mean
707142|NCT00113763|Post-Hoc|Progression-free Survival Time (Mutant KRAS)|Kaplan-Meier estimates of median time from randomization to either death or first observed disease progression among participants with mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS) status. Participants were evaluated for tumor response according to modified Response Evaluation Criteria in Solid Tumors (RECIST) based on the response assessment from a blinded review of radiographic scans by the Independent Review Committee. Progressive disease defined as least a 20% increase in the sum of the longest diameters (SLD) of target lesions, taking as reference the nadir SLD recorded since the treatment started or the appearance of one or more new lesions, or the unequivocal progression of existing non-target lesions.|From randomization until the data cutoff of 15 March 2007. The median follow-up time in patients with mutant KRAS was 24.4 weeks in the panitumumab plus BSC group and 23.9 weeks in the BSC alone group.|Mutant KRAS Efficacy Analysis Set, a subset of the Intention-to-Treat set with mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS) status.||weeks||95% Confidence Interval|Median
707143|NCT00113763|Post-Hoc|Progression-free Survival Time (Wild-type KRAS)|Kaplan-Meier estimates of median time from randomization to either death or first observed disease progression among participants with wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS) status. Participants were evaluated for tumor response according to modified Response Evaluation Criteria in Solid Tumors (RECIST) based on the response assessment from a blinded review of radiographic scans by the Independent Review Committee. Progressive disease defined as least a 20% increase in the sum of the longest diameters (SLD) of target lesions, taking as reference the nadir SLD recorded since the treatment started or the appearance of one or more new lesions, or the unequivocal progression of existing non-target lesions.|From randomization until the data cutoff of 15 March 2007. The median follow-up time in patients with wild-type KRAS was 36.8 weeks in the panitumumab plus BSC group and 35.7 weeks in the BSC alone group.|Wild-type KRAS Efficacy Analysis Set, a subset of the Intention-to-Treat set with wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS) status.||weeks||95% Confidence Interval|Median
707144|NCT00113763|Secondary|Duration of Stable Disease|Kaplan-Meier estimate of the median time from randomization to date of first observed progression of disease or death due to progression of disease (whichever comes first) for those participants with a best response of stable disease. Stable disease defined as neither sufficient shrinkage to qualify for a partial response nor sufficient increase to qualify for progressive disease taking as reference the nadir longest diameter since the treatment started, no unequivocal progression of existing non-target lesions, and no new lesions.|From randomization until the data cutoff of 15 March 2007. The median follow-up time was 29.6 weeks in the panitumumab plus BSC group and 31.8 weeks in the BSC alone group.|Participants who had a best overall response of stable disease||weeks||95% Confidence Interval|Median
707145|NCT00113763|Secondary|Time to Treatment Failure|Kaplan-Meier estimate of the median time from randomization to the date the decision was made to end treatment for any reason.|From randomization until the data cutoff of 15 March 2007. The median follow-up time was 29.6 weeks in the panitumumab plus BSC group and 31.8 weeks in the BSC alone group.|Intention-to-treat (ITT)||weeks||95% Confidence Interval|Median
707146|NCT00113763|Secondary|Time to Disease Progression|Kaplan-Meier estimates of median time from randomization to disease progression or death due to disease progression (whichever occurs first)|From randomization until the data cutoff of 15 March 2007. The median follow-up time was 29.6 weeks in the panitumumab plus BSC group and 31.8 weeks in the BSC alone group.|Intention-to-treat||weeks||95% Confidence Interval|Median
707217|NCT00121238|Secondary|Median Survival Time|6 of 13 patients were alive at five years. The Median survival time was calculated for all patients.|Up to 5 years|||months||95% Confidence Interval|Median
707147|NCT00113763|Secondary|Time to Response|Time to response was defined as the time from randomization to first partial or complete response, subsequently confirmed ≥ 4 weeks after the criteria for response were first met.|From randomization until the data cutoff of 15 March 2007. The median follow-up time was 29.6 weeks in the panitumumab plus BSC group and 31.8 weeks in the BSC alone group.|Intention-to-treat (ITT) participants who had a confirmed objective tumor response. No objective tumor responses were observed in the BSC alone treatment arm.||weeks||Inter-Quartile Range|Median
707148|NCT00113763|Secondary|Duration of Response|Kaplan-Meier estimate of the median time from first confirmed objective tumor response to first observed progression of disease or death due to progression of disease (whichever comes first).|From randomization until the data cutoff of 15 March 2007. The median follow-up time was 29.6 weeks in the panitumumab plus BSC group and 31.8 weeks in the BSC alone group.|Intention-to-treat participants who had a confirmed objective tumor response. No objective tumor responses were observed in the BSC alone treatment arm.||weeks||95% Confidence Interval|Median
707149|NCT00113763|Secondary|Objective Tumor Response|Defined as the number of participants with a confirmed complete or partial tumor response, confirmed by a scan no less than 4 weeks after the criteria for response were first met. Participants were evaluated for tumor response according to modified Response Evaluation Criteria in Solid Tumors (RECIST) based on the response assessment from a blinded review of radiographic scans by the Independent Review Committee. Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions. Partial Response (PR): disappearance of all target lesions, and persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease, or, at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline SLD, with no progressive disease of non-target lesions.|From randomization until the data cutoff of 15 March 2007. The median follow-up time was 29.6 weeks in the panitumumab plus BSC group and 31.8 weeks in the BSC alone group.|Intention-to-treat (ITT)||participants|||Number
707150|NCT00113763|Secondary|Overall Survival|Kaplan-Meier estimates of median time from randomization to death.|From randomization until the data cut-off date for overall survival of 15 March 2006. The median actual follow-up time was 30 weeks for the panitumumab plus BSC group and 31 weeks for the BSC alone group.|Intention-to-treat (ITT)||months||95% Confidence Interval|Median
707151|NCT00113763|Primary|Progression-free Survival Time|Kaplan-Meier estimates of median time from randomization to either death or first observed disease progression, whichever occurred first. Participants were evaluated for tumor response according to modified Response Evaluation Criteria in Solid Tumors (RECIST) based on the response assessment from a blinded review of radiographic scans by the Independent Review Committee. Progressive disease defined as least a 20% increase in the sum of the longest diameters (SLD) of target lesions, taking as reference the nadir SLD recorded since the treatment started or the appearance of one or more new lesions, or the unequivocal progression of existing non-target lesions.|From randomization to the data cut-off date of 30 June 2005. The median follow-up time was 20.0 weeks in the panitumumab plus BSC group and 18.2 weeks in the BSC alone group.|Intention-to-treat (ITT)||weeks||95% Confidence Interval|Median
707152|NCT00113841|Primary|Percent Change of NF-kB Protein Expression in Peripheral Blood Mononuclear Cells From Baseline Through 4 Weeks of Treatment|Percent change of NF-kB =[(expression at 4 weeks- expression at baseline)/expression at baseline]*100%. Bone marrow aspirate/biopsy for expression of NF-kB and related genes/proteins markers at baseline and after 4 weeks.|Baseline through 4 weeks of treatment|All participants in the two arms (Curcumin versus Curcumin plus Bioperine) who received at least 4 weeks of treatment were eligible for outcome evaluation.||Percent reduction||Standard Deviation|Mean
707153|NCT00113880|Secondary|Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season)||Within 14 days of vaccination|Subsets of FluMist recipients 5-8, 9-17, and 18-49 years of age||Percentage of FluMist recipients|||Number
707154|NCT00113880|Secondary|Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season)||Within 2-3 days of vaccination|Subsets of FluMist recipients 5-8, 9-17, and 18-49 years of age||Percentage of FluMist recipients|||Number
707155|NCT00113880|Secondary|Rates of SAEs and Hospitalizations or Deaths Within 180 Days in the Subset of Individuals Who Received FluMist in 2 or More Consecutive Years Compared to Rates in Unvaccinated and TIV Controls|Incident rate comparisons of SAEs and hospitalizations or deaths with an identified decreased risk associated with FluMist recipients compared to TIV recipients; there were no significant decreases compared to the unvaccinated controls. There were no SAE and hospitalization or death incidence rate comparisons that were significantly increased in FluMist recipients compared to their controls.|180 days|Analyses were performed by period (180 days) and age group (5-8, 9-17, 18-49 years of age), post Dose 1. recipients who were part of the main analysis and received FluMist in both the current and the immediate prior season(s) were included in this analysis. Significance was observed for any hospitalization or death, for all ages and 18-49.||Cases per 1,000 person-months|Participants||Number
707156|NCT00113880|Secondary|Rates of MAEs Associated With a Significant Decreased Risk Within 180 Days in the Subset of Individuals Who Received FluMist in 2 or More Consecutive Years Compared to Rates in TIV Controls|Incident rate comparisons of MAEs within 180 days with an identified decreased risk associated with FluMist recipients compared to TIV recipients. There were no MAE incidence rate comparisons that were significantly increased in FluMist recipients compared to TIV recipients.|180 days|Analyses performed by period (180 days), age group (5-8, 9-17, 18-49 years of age), and setting (clinic, hospital, or ED), post Doe 1. FluMist recipients who were part of the main analysis and received FluMist in both the current and the immediate prior season(s) were included in this analysis. Significance observed across all settings.||Cases per 1,000 person-months|Participants||Number
707157|NCT00113880|Secondary|Rates of MAEs Associated With a Significant Decreased Risk Within 180 Days in the Subset of Individuals Who Received FluMist in 2 or More Consecutive Years Compared to Rates in Unvaccinated Controls|Incident rate comparisons of MAEs within 180 days with an identified decreased risk associated with FluMist recipients compared to Unvaccinated Controls. There were no MAE incidence rate comparisons that were significantly increased in FluMist recipients compared to Unvaccinated Controls.|180 days|Analyses performed by period (180 days), age group (5-8, 9-17, 18-49 years of age), and setting (clinic, hospital, or ED), post Doe 1. FluMist recipients who were part of the main analysis and received FluMist in both the current and the immediate prior season(s) were included in this analysis. Significance observed across all settings.||Cases per 1,000 person-months|Participants||Number
707158|NCT00113880|Secondary|Rates of MAEs Associated With a Significant Decreased Risk in the Subset of Individuals Who Received FluMist in 2 or More Consecutive Years Compared to Rates in TIV Controls Within 42 Days|Incident rate comparisons of MAEs with an identified decreased risk in FluMist recipients receiving FluMist in 2 or more consecutive seasons compared to rates in TIV recipients within 42 days. There was no significant decreased risk in comparison to unvaccinated controls within the 42-day timeframe.|42 days|Analyses performed by period (3, 21, and 42 days), age group (5-8, 9-17, 18-49 years of age), and setting (clinic, hospital, or ED), post Doe 1. FluMist recipients who were part of the main analysis and received FluMist in both the current and the immediate prior season(s) were included in this analysis. Significance observed across all settings.||Cases per 1,000 person-months|Participants||Number
707159|NCT00113880|Secondary|Rates of MAEs Associated With a Significant Increased Risk in the Subset of Individuals Who Received FluMist in 2 or More Consecutive Years Compared to Rates in Unvaccinated Controls|Incident rate comparisons of MAEs with an identified increased risk in FluMist recipients receiving FluMist in 2 or more consecutive seasons compared to rates in unvaccinated recipients. There was no increased risk at 3 or 21 days and there was no increased risk compared to the Within Cohort or TIV control groups.|42 days|Analyses performed by period (3, 21, and 42 days), age group (5-8, 9-17, 18-49 years of age), and setting (clinic, hospital, or ED), post Doe 1. FluMist recipients who were part of the main analysis and received FluMist in both the current and the immediate prior season(s) were included in this analysis. Significance observed across all settings.||Cases per 1,000 person-months|Participants||Number
707160|NCT00113880|Secondary|Rates of MAEs Associated With a Significant Decreased Risk in the Subset of Individuals Who Received FluMist in 2 or More Consecutive Years Compared to Rates in Within Cohort Controls|Incident rate comparisons of MAEs with an identified decreased risk in FluMist recipients receiving FluMist in 2 or more consecutive seasons compared to rates in within cohort controls within 21 days. There was no significant decreased risk in comparison to unvaccinated or TIV controls within the 21-day timeframe.|21 days|Analyses performed by period (3, 21, and 42 days), age group (5-8, 9-17, 18-49 years of age), and setting (clinic, hospital, or ED), post Doe 1. FluMist recipients who were part of the main analysis and received FluMist in both the current and the immediate prior season(s) were included in this analysis. Significance observed across all settings.||Cases per 1,000 person-months|Participants||Number
707161|NCT00113880|Primary|Rates of Hospitalizations and Deaths Within 180 Days in FluMist Recipients Compared to Rates in TIV Controls|Incident rate comparisons of hospitalizations and deaths with an identified decreased risk associated with FluMist compared to TIV controls. There were no hospitalization or death incidence rate comparisons that were significantly increased in FluMist recipients.|180 days|Analyses were performed by period (180 days), age group (5-8, 9-17, 18-49 years of age), and number of doses (one or two for ages 5-8 years). Significance was observed in the hospital/death setting 180 days post Dose 1, for all ages and 18-49.||Cases per 1,000 person-months|Participants||Number
707162|NCT00113880|Primary|Rates of Hospitalizations and Deaths Within 180 Days in FluMist Recipients Compared to Rates in Unvaccinated Controls|Incident rate comparisons of hospitalizations and deaths with an identified decreased risk associated with FluMist compared to unvaccinated controls. There were no hospitalization or death incidence rate comparisons that were significantly increased in FluMist recipients.|180 days|Analyses were performed by period (180 days), age group (5-8, 9-17, 18-49 years of age), and number of doses (one or two for ages 5-8 years). Significance was observed in the hospitalization/death setting, 180 days post Dose 1, for all ages and 18-49.||Cases per 1,000 person-months|Participants||Number
707163|NCT00113880|Primary|Rates of SAEs in FluMist Recipients Compared to Rates in TIV Controls|Incident rate comparisons of SAEs with an identified decreased risk associated with FluMist compared to TIV controls. There were no SAE incidence rate comparisons that were significantly increased in FluMist recipients.|21 and 42 days|Analyses were performed by period (21 and 42 days), age group (5-8, 9-17, 18-49 years of age), setting (clinic, hospital, or ED), and number of doses (one or two for ages 5-8 years). Significance was observed in the any/death setting, 21 and 42 days post Dose 1, for all ages and 18-49.||Cases per 1,000 person-months|Participants||Number
707164|NCT00113880|Primary|Rates of Serious Adverse Events (SAEs) in FluMist Recipients Compared to Rates in Unvaccinated Control Group|Incident rate comparisons of SAEs with an identified decreased risk associated with FluMist compared to unvaccinated controls; no decreased risk was observed in compariosn to the within cohort control. There were no SAE incidence rate comparisons that were significantly increased in FluMist recipients.|21 and 42 days|Analyses were performed by period (21 and 42 days), age group (5-8, 9-17, 18-49 years of age), setting (clinic, hospital, or ED), and number of doses (one or two for ages 5-8 years). Significance was observed in the any/death setting, 21 and 42 days post Dose 1, for all ages and 18-49.||Cases per 1,000 person-months|Participants||Number
707165|NCT00113880|Primary|Rare Events Potentially Related to Wild-type Influenza in FluMist Recipients Compared to TIV and Unvaccinated Control Groups|Incident rate comparisons associated with a significantly decreased risk in FluMist recipients compared to TIV controls; there was no significantly decreased risk compared to the within cohort and unvaccinated controls. No MAEs potentially related to wild-type influenza were associated with a significantly increased risk in FluMist recipients.|21 and 42 days|Analyses were performed by period (21 and 42 days), age group (5-8, 9-17, 18-49 years of age), setting (clinic, hospital, or ED), and number of doses (one or two for ages 5-8 years). significance was observed for encephalitis/encephalopathy, for all age groups, across all settings within 42 days, PD1.||Cases per 1,000 person-months|Participants||Number
707166|NCT00113880|Primary|Rates of Asthma and Wheezing Within 180 Days in FluMist Recipients Compared to Rates in the TIV Control Group|Incident rate comparisons associated with a significantly decreased risk in FluMist recipients compared to the TIV control group for all ages, 5-8, 9-17, and 18-49 years of age. No asthma and wheezing incidence rate comparisons were significantly increased in FluMist recipients compared to the TIV control group.|180 days|Analyses performed by period (180 days), age group (5-8, 9-17, 18-49 yrs), setting (clinic, hospital, or ED), and number of doses (1 or 2 for 5-8 yrs). Significance was observed for asthma/RAD, wheezing/shortness of breath (SOB), and any ashtma or wheezing event across all settings, PD1 (all age groups) and PD2.||Cases per 1,000 person-months|Participants||Number
707509|NCT00123630|Primary|Change in Eosinophil Numbers Per High Power Field Proximally and Distally Between Baseline and Post-treatment and Between Both Groups||16 weeks|The analysis was per protocol. There were no subjects who were withdrawn or lost to follow-up in this study.||perecentage of eos per high power field|||Number
707167|NCT00113880|Primary|Rates of Asthma and Wheezing Within 180 Days in FluMist Recipients Compared to Rates in the Unvaccinated Control Group|Incident rate comparisons associated with a significantly decreased risk in FluMist recipients compared to the unvaccinated control group for all ages, 5-8, and 9-17 years of age. No asthma and wheezing incidence rate comparisons were significantly increased in FluMist recipients compared to the unvaccinated control group.|180 days|Analyses performed by period (180 days), age group (5-8, 9-17, 18-49 yrs), setting (clinic, hospital, or ED), and number of doses (1 or 2 for 5-8 yrs). Significance was observed for asthma/reactive airway disease (RAD) and any ashtma or wheezing event across all settings, PD1 (all ages and 9-17 yrs) and PD2 (5-8 yrs).||Cases per 1,000 person-months|Participants||Number
707168|NCT00113880|Primary|Rates of Asthma and Wheezing Within 21 and 42 Days in FluMist Recipients Compared to Rates in the TIV Control Group|Incident rate comparisons associated with a significantly decreased risk in FluMist recipients compared to the TIV control group for all ages, 5-8, 9-17, and 18-49 years of age. No asthma and wheezing incidence rate comparisons were significantly increased in FluMist recipients compared to the TIV control group.|21 and 42 days|Analyses were performed by period (21 and 42 days), age group (5-8, 9-17, 18-49 years of age), setting (clinic, hospital, or ED), and number of doses (one or two for ages 5-8 years). Significance was observed across all settings, post Dose 1 within 21 days and 42 days (all age groups) and post Dose 2 (PD2) within 42 days (5-8 yrs).||Cases per 1,000 person-months|Participants||Number
707169|NCT00113880|Primary|Rates of Asthma and Wheezing Within 21 and 42 Days in FluMist Recipients Compared to Rates in the Within Cohort and Unvaccinated Control Groups|Incident rate comparisons associated with a significantly decreased risk in FluMist recipients compared to the within cohort control observed for all ages and 5-8 years of age within 21 days and compared to the unvaccinated control obseved for 18-49 years of age within 42 days. No asthma and wheezing incidence rate comparisons were significantly increased in FluMist recipients compared to the within cohort or unvaccinated control groups.|21 and 42 days|Analyses were performed by period (21 and 42 days), age group (5-8, 9-17, 18-49 years of age), setting (clinic, hospital, or ED), and number of doses (one or two for ages 5-8 years). Significance was observed across all settings, post Dose 1 within 21 days for within cohort and within 42 days for unvaccinated.||Cases per 1,000 person-months|Participants||Number
707170|NCT00113880|Primary|Rates of MAEs Within the Pre-specified Grouped Diagnoses In The FluMist Group Compared to Rates in Within Cohort, Unvaccinated, and TIV Control Groups.|There were no acute respiratory tract events, acute gastrointestinal tract events, or systemic bacterial infections with an identified increased or decreased risk associated with FluMist occuring in the same age group and setting across all three comparison groups.|21 and 42 days|Analyses were performed by period (21 and 42 days), age group (5-8, 9-17, 18-49 years of age), setting (clinic, hospital, or ED), and number of doses (one or two for ages 5-8 years).||Cases per 1,000 person-months|Participants||Number
707171|NCT00113880|Primary|Rates of Anaphylaxis and Urticaria in FluMist Recipients Compared to Rates in Within Cohort, Unvaccinated, and TIV Control Groups|Incident rate comparisons associated with a significantly increased risk in FluMist recipients compared to the within cohort control group for urticaria; there was no increased risk compared to the unvaccinated and TIV control groups and there were no anaphylaxis events that occurred within the 3-day risk period post vaccination.|3 days|Analyses were performed by period (3 days), age group (5-8, 9-17, 18-49 years of age), setting (clinic, hospital, or ED), and number of doses (one or two for ages 5-8 years).||Cases per 1,000 person-months|Participants||Number
707172|NCT00113880|Primary|Rates of MAEs Associated With a Significant Decreased Risk in FluMist Group Compared to Rates in Within Cohort, Unvaccinated, and TIV Control Groups|Incident rate comparisons of MAEs with an identified decreased risk associated with FluMist occuring in the same age group and setting across all three comparison groups, as these events are less likely to be due to chance alone. All terms were analyzed for the entire population regardless of gender.|21 and 42 days|Analyses performed by period (21 and 42 days), age group (5-8, 9-17, 18-49 years of age), setting (clinic, hospital, or ED), and number of doses (1 or 2 for ages 5-8 years). Significance observed in the clinic, 21 days post Dose 1 in 1 subj. (heart murmur, all ages combined); 18 and 19 subj.(pregnancy exam, 18-49 and all ages combined).||Cases per 1,000 person-months|Participants||Number
707173|NCT00113880|Primary|Rates of Medically Attended Events (MAEs) Associated With a Significant Increased Risk in FluMist Recipients Compared to Rates in Within Cohort, Unvaccinated, and TIV Control Groups|An MAE was defined as a coded medical diagnosis made by a health care provider and associated with a medical encounter (ie, a visit by a health plan member to a medical clinic or ED, or a hospital admission). Incident rate comparisons of MAEs with an identified increased risk associated with FluMist occurring in the same age group and setting across all three comparison groups, as these events are less likely to be due to chance alone.|21 and 42 days|Analyses were performed by period (21 and 42 days), age group (5-8, 9-17, 18-49 years of age), setting (clinic, hospital, or ED), and number of doses (one or two for ages 5-8 years). Significance was observed in the clinic setting, 21 days post Dose 1 in 7 subjects (breast lump/cyst, 9-17 yrs) and in 22 subjects (mastitis, 18-49 yrs).||Cases per 1,000 person-months|Participants||Number
707176|NCT00119678|Secondary|OL; Number of Participants With Antibodies Specific for CTLA4-T and Abatacept, Following Abatacept Treatment|MSD technology was used to detect antibodies specific for CTLA4-T and for abatacept.|After the first dose of open-label period|Immunogenicity analysis population: participants who received abatacept and for whom baseline and at least one additional measurement during the open-label period were available.||participants|||Number
707218|NCT00121238|Secondary|The Number of Participants With at Least One Incident of Toxicity|Toxicity was evaluated by NCI-CTCAE (ver. 3) criteria in all 15 treated patients (16 patients were enrolled however one progressed prior to treatment) including the two ineligible patients.|Up to 5 years|All treated patients, including 2 patients who were deemed ineligible for the study's endpoints to measure efficacy.||participants|||Number
707177|NCT00119678|Secondary|OL; Area Under the Curve (AUC) for Prednisone or Prednisone Equivalent|Total exposure to glucocorticosteroid was measured by the total prednisone or prednisone equivalent AUC. Based on the recommendation of the Data Monitoring Committee, the open-label, long-term extension period was terminated by the sponsor, for failure to meet the primary outcome measure for the double-blind period and because of an increase in SAEs in the abatacept treatment group. As such, these data were not analyzed.|From start of study drug therapy in open-label period (Day 365), Day 393, 421, 449 and every 28 days thereafter till Day 729.|As treated analysis population: All treated participants who entered the open-label period and received at least one dose of study medication during open-label period.|||||
707178|NCT00119678|Secondary|OL; Total Number of BILAG A Flares Each Participant Experienced|Total number of BILAG A flares in any organ system after steroid tapering = new BILAG A features in any organ system. Scores defined as follows: None: participants with no BILAG A flare; 1: participants with 1 BILAG A flare or participants who discontinued without a new BILAG A flare were imputed as having one event. 2: participants with 2 BILAG A flares; 3 or >3: participants with 3 or more BILAG A flares.Based on recommendation of Data Monitoring Committee, open-label period terminated, as failed to meet primary outcome measure for double-blind period/increase in SAEs in abatacept group.|From start of study drug therapy in open-label period (Day 365), Day 393, 421, 449 and every 28 days thereafter till Day 729.|As treated analysis population: All treated participants who entered the open-label period and received at least one dose of study medication during open-label period.|||||
707179|NCT00119678|Secondary|OL; Number of Participants With a Change in the SLICC/ACR Damage Index at Year 2 Compared to Baseline|SLICC/ACR damage index:measure of cumulative damage due to SLE.Damage=non-reversible change occurring since onset of lupus,ascertained by clinical assessment & present for =>6 months.Scores of SLICC/ACR index:1:single episode;2:repeated episodes at least 6 months apart.Change in score from baseline to 1 year presented as:no change,increase 1 (an increase in score of 1),increase >1 (an increase in score of >1).Based on recommendation of Data Monitoring Committee, open-label period terminated, as failed to meet primary outcome measure for double-blind period/increase in SAEs in abatacept group.|From start of study drug therapy in open-label period (Day 365) and on Day 729.|As treated analysis population: All treated participants who entered the open-label period and received at least one dose of study medication during open-label period.|||||
707180|NCT00119678|Secondary|OL; Number of Participants With a New SLE Flare|SLE flares scored using BILAG:A:presence of =>1 serious lupus features;B:more moderate features;C:mild symptomatic features;D:prior activity with no current symptoms due to active lupus;E:an organ that has never been involved.BILAG scores based on degrees of change in clinical features (1=improving,2=staying the same,3=worsening,4=new).New SLE flare means new BILAG A/B features in any organ system.Based on the recommendation of the Data Monitoring Committee, open-label period terminated, as failed to meet primary outcome measure for double-blind period/increase in SAEs in abatacept group.|From start of study drug therapy in open-label period (Day 365), Day 393, 421, 449 and every 28 days thereafter till Day 729.|As treated analysis population: All treated participants who entered the open-label period and received at least one dose of study medication during open-label period.|||||
707181|NCT00119678|Secondary|DB; Number of Participants With Antibodies Specific for CTLA4-T and Abatacept, Following Abatacept Treatment|Electrochemiluminescence (ECL) immunoassay based on Meso Scale Discovery (MSD) technology was used to detect antibodies specific for CTLA4-T and for abatacept.|From Day 1 to Day 365|Participants who received abatacept and for whom baseline and at least one additional measurement during double-blind period were available.||participants|||Number
707182|NCT00119678|Primary|OL; Number of Participants With MAs in Urinalysis|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following definitions specify the criteria for MAs in urinalysis, Protein, glucose, blood, Leukocyte esterase, red blood cells (RBC), white blood cells (WBC): >=2+ (or, if value >=4, or if pre-Rx value = 0 or 0.5, then >= 2* or if pre-Rx value =1, then >=3, or if pre-Rx = 2 or 3, then >=4); protein (24 hour urine): >1000 mg/24 hrs and >=2* pre-Rx; Glomerular filtration rate (GFR): <=60 mL/min/1.73m^2 or > 15% change from baseline; Protein/creatinine ratio: > 100 mg/mmol.|From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period|"As treated analysis population: all treated participants who entered the OL period and received at least 1 dose of study medication. Where not evaluable was recorded for low (protein, glucose, blood, leukocyte esterase, RBC, WBC) or high(GFR) values and presented as 0. n=number of participants with evaluable results (each arm respectively)."||participants|||Number
707183|NCT00119678|Primary|OL; Number of Participants With MAs in Serum Chemistry: Glucose (Serum), Glucose (Fasting Serum), Albumin, Cholesterol (Total), Triglycerides, Fasting Triglycerides|MAs are laboratory measurements marked as abnormal, as per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria, Glucose: <65 mg/dL or >220 mg/dL; Glucose (fasting serum): <0.8* LLN or >1.5 ULN (if pre-Rx <LLN, then <0.8* pre-Rx or >ULN. If pre-Rx >ULN, then >2.0* pre-Rx or <LLN; Albumin: <0.9* LLN (if pre-Rx <LLN, then <0.75 * pre-Rx); cholesterol (total): >2* pre-Rx; triglycerides: >=2.5* ULN, or if pre Rx>ULN then use >2.5* pre Rx; fasting triglycerides: >=2.0* ULN, or if pre Rx>ULN then use >2.0* pre Rx.|From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period|"As treated analysis population: All treated participants who entered the open-label period and received at least one dose of study medication. Where not evaluable was recorded for either low (cholesterol, triglycerides) or high (albumin) has been presented as 0. n = number of participants with evaluable results (each arm respectively)."||participants|||Number
707184|NCT00119678|Primary|OL; Number of Participants With MAs in Serum Chemistry: Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total), Protein (Total)|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria, Sodium (serum): <0.95x LLN or >1.05x ULN (if pre-Rx<LLN, then <0.95x pre-Rx or >ULN. If pre-Rx >ULN, then >1.05x pre-Rx or <LLN); Potassium (serum), Chloride (serum), protein (total): <0.9x LLN or >1.1xULN (if pre-Rx <LLN, then <0.9xpre-Rx or >ULN. If pre-Rx >ULN, then >1.1xpre-Rx or <LLN; Calcium (total): <0.8xLLN or >1.2xULN (if pre-Rx <LLN, then <0.75x pre-Rx or >ULN. If pre-Rx >ULN, then >1.25x pre-Rx or <LLN.|From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period|As treated analysis population: All treated participants who entered the open-label period and received at least one dose of study medication during open-label period.||participants|||Number
707185|NCT00119678|Primary|OL; Number of Participants With MAs in Serum Chemistry: Alkaline Phosphatase (ALP), Aspartate-aminotransferase (AST), Alanine-aminotransferase (ALT), Gamma-glutamyl Transferase (GGT), Bilirubin(Total), Blood Urea Nitrogen (BUN), Creatinine|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria. ALP, GGT: >2* ULN (if pre-Rx >ULN, then >3* pre-Rx); AST, ALT: >3* ULN (if pre-Rx >ULN, then >4* pre-Rx). Bilirubin (total): >2* ULN (if pre-Rx >ULN, then >4* pre-Rx), BUN:>2* pre-Rx; Creatinine:>1.5* pre-Rx.|From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period|"As treated analysis population: All treated participants who entered the open-label period and received at least one dose of study medication during open-label period. Where not evaluable was recorded for low values (ALP, AST, ALT, GGT, bilirubin, BUN, creatinine) and has been presented as 0."||participants|||Number
707186|NCT00119678|Primary|OL; Number of Participants With MAs in Hematology: Leukocytes, Neutrophils + Bands (Absolute), Lymphocytes (Absolute), Monocytes (Absolute), Basophils (Absolute) and Eosinophils (Absolute)|MMAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following hematology MA definitions specify the criteria for the data presented. Leukocytes: <0.75* LLN or >1.25* ULN (or, if pre-Rx value <LLN, then <0.8* pre-Rx or >ULN. If pre-Rx value >ULN, then >1.2* pre-Rx or <LLN; Neutrophils+bands (absolute): <1.00* 10^3 cells/microliter (c/uL); Lymphocytes (absolute): <0.75* 10^3 c/uL or >7.50* 10^3 c/uL; Monocytes (absolute): >2000/mm^3; Basophils (absolute): >0.40* 10^3 c/uL; Eosinophils (absolute): >0.75* 10^3 c/uL.|From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period|"As treated analysis population: All treated participants who entered the open-label period and received at least one dose of study medication during open-label period. Where not evaluable was recorded for either low(monocytes, basophils, eosinophils) or high(neutrophils) has been presented as 0."||participants|||Number
707187|NCT00119678|Primary|OL; Number of Participants With Marked Abnormalities (MAs) in Hematology: Hemoglobin, Hematocrit, Erythrocytes and Platelet Count|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following hematology MA definitions specify the criteria for the data presented. Hemoglobin: >3 g/dL decrease from pre-treatment (pre-Rx) value; hematocrit: <0.75* pre-Rx value; erythrocyte count: <0.75* pre-Rx value; platelet count: <0.67* lower limit of normal (LLN) or >1.5* upper limit of normal (ULN) (or, if pre-Rx value <LLN, then <0.5* pre-Rx value or <100000/mm^3).|From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period|"As treated analysis population: All treated participants who entered the open-label period and received at least one dose of study medication. Where not evaluable was recorded for high values (hemoglobin, hematocrit, erythrocytes) and has been presented as 0. n = number of participants with evaluable results (each arm respectively)."||participants|||Number
707188|NCT00119678|Primary|OL; Number of Participants With Significant AEs of Special Interest|An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition (even if not caused by the study drug). For this study, it was decided that AEs of particular importance were associated with the use of immunomodulatory agents. Number of participants with infections, malignant Neoplasms, pre-specified autoimmune disorders, acute-infusional AEs and peri-infusional AEs were recorded.|From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period|As treated analysis population: All treated participants who entered the open-label period and received at least one dose of study medication during open-label period.||participants|||Number
707189|NCT00119678|Primary|Open Label Period (OL); Number of Participants Who Died, Experienced Adverse Events (AEs), Serious AEs, Drug Related AEs or SAEs and Discontinued Due to AEs|AEs: any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to an AE were recorded. Drug-related AEs or SAEs: events with a relationship to the study therapy of certain; probable; possible; or missing.|From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period|As treated analysis population: All treated participants who entered the open-label period and received at least one dose of study medication during open-label period.||participants|||Number
707190|NCT00119678|Secondary|DB; Number of Participants With Clinically Significant Abnormal Vital Signs and/or Physical Examination Findings|Vital signs assessments and physical examination were conducted throughout the study. Vital signs assessments included body temperature, respiratory rate, blood pressure (systolic and diastolic) and heart rate. The investigator used his/her clinical judgment to decide whether or not abnormalities in vital signs or physical examination were clinically meaningful.|Events recorded at each participant encounter, from start of study drug therapy up to Day 337, including up to 56 days after the last dose or up to the first dose of open-label, whichever occurred earlier|"All participants given study drug during the double-blind period (As Treated). Significant vital signs and physical examination findings are reported in the AE tables. Symptoms related to lupus were collected in British Isles Lupus Assessment Group (BILAG) assessments."|||||
707191|NCT00119678|Secondary|DB; Number of Participants With MAs in Urinalysis|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following definitions specify the criteria for MAs in urinalysis, Protein, glucose, blood, Leukocyte esterase, RBC, WBC: >=2+ (or, if value >=4, or if pre-Rx value = 0 or 0.5, then >= 2* pre-Rx, or if pre-Rx value =1, then >=3, or if pre-Rx = 2 or 3, then >=4); protein (24 hour urine): >1000 mg/24 hrs and >=2* pre-Rx; GFR: <=60 mL/min/1.73m^2 or > 15% change from baseline; Protein/creatinine ratio: > 100 mg/mmol.|Events recorded at each participant encounter, from start of study drug therapy up to Day 337, including up to 56 days after the last dose or up to the first dose of open-label, whichever occurred earlier|"All participants given study drug during the double-blind period (As Treated) where not evaluable was recorded for low (protein, glucose, blood, leukocyte esterase, RBC, WBC) or high (GFR) values has been presented as 0. n=number of participants with evaluable results (each arm respectively)."||participants|||Number
707219|NCT00121238|Secondary|Median PSA Slope Difference|Median PSA slope difference was calculated between baseline and 6 months.|Baseline to 6 months|||ng/mL/month||Inter-Quartile Range|Median
707192|NCT00119678|Secondary|DB; Number of Participants With MAs in Serum Chemistry: Glucose (Serum), Glucose (Fasting Serum), Albumin, Cholesterol (Total), Triglycerides, Fasting Triglycerides|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria, Glucose: <65 mg/dl or >220 mg/dl; Glucose (fasting serum): <0.8* LLN or >1.5 ULN (if pre-Rx <LLN, then <0.8* pre-Rx or >ULN. If pre-Rx >ULN, then >2.0* pre-Rx or <LLN; Albumin: <0.9* LLN (if pre-Rx <LLN, then <0.75 * pre-Rx); cholesterol (total): >2* pre-Rx; triglycerides: >=2.5* ULN, or if pre Rx>ULN then use >2.5* pre Rx; fasting triglycerides: >=2.0* ULN, or if pre Rx>ULN then use >2.0* pre Rx.|Events recorded at each participant encounter, from start of study drug therapy up to Day 337, including up to 56 days after the last dose or up to the first dose of open-label, whichever occurred earlier|"All participants given study drug during the double-blind period (As Treated) where not evaluable was recorded for either low or high values (albumin, cholesterol, triglycerides) has been presented as 0.n=number of participants with evaluable results (each arm respectively)."||participants|||Number
707193|NCT00119678|Secondary|DB; Number of Participants With MAs in Serum Chemistry: Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total),Protein (Total)|MAs are laboratory measurements marked as abnormal as per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria, Sodium (serum): <0.95* LLN or >1.05* ULN (if pre-Rx <LLN, then <0.95* pre-Rx or >ULN. If pre-Rx >ULN, then >1.05* pre-Rx or <LLN); Potassium (serum), Chloride (serum), protein (total): <0.9* LLN or >1.1* ULN (if pre-Rx <LLN, then <0.9* pre-Rx or >ULN. If pre-Rx >ULN, then >1.1* pre-Rx or <LLN; Calcium (total): <0.8* LLN or >1.2* ULN (if pre-Rx <LLN, then <0.75* pre-Rx or >ULN. If pre-Rx >ULN, then >1.25* pre-Rx or <LLN.|Events recorded at each participant encounter, from start of study drug therapy up to Day 337, including up to 56 days after the last dose or up to the first dose of open-label, whichever occurred earlier|"All participants given study drug during the double-blind period (As Treated).n=number of participants with evaluable results (each arm respectively)."||participants|||Number
707194|NCT00119678|Secondary|DB: Number of Participants With MAs in Serum Chemistry: ALP, AST, ALT, GGT, Bilirubin (Total), BUN and Creatinine|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria. ALP, GGT: >2* ULN (if pre-Rx >ULN, then >3* pre-Rx); AST, ALT: >3* ULN (if pre-Rx >ULN, then >4* pre-Rx). Bilirubin (total): >2* ULN (if pre-Rx >ULN, then >4* pre-Rx), BUN:>2* pre-Rx; Creatinine:>1.5* pre-Rx.|Events recorded at each participant encounter, from start of study drug therapy up to Day 337, including up to 56 days after the last dose or up to the first dose of open-label, whichever occurred earlier|"All participants given study drug during the double-blind period (As Treated) where not evaluable was recorded for low values (all parameters) and has been presented as 0. n=number of participants with evaluable results (each arm respectively)."||participants|||Number
707195|NCT00119678|Secondary|DB; Number of Participants With MAs in Hematology: Leukocytes, Neutrophils + Bands (Absolute), Lymphocytes (Absolute), Monocytes (Absolute), Basophils (Absolute) and Eosinophils (Absolute)|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following hematology MA definitions specify the criteria for the data presented. Leukocytes: <0.75* LLN or >1.25* ULN (or, if pre-Rx value <LLN, then <0.8* pre-Rx or >ULN. If pre-Rx value >ULN, then >1.2* pre-Rx or <LLN; Neutrophils+bands (absolute): <1.00* 10^3 cells/microliter (c/uL); Lymphocytes (absolute): <0.75* 10^3 c/uL or >7.50* 10^3 c/uL; Monocytes (absolute): >2000/mm^3; Basophils (absolute): >0.40* 10^3 c/uL; Eosinophils (absolute): >0.75* 10^3 c/uL.|Events recorded at each participant encounter, from start of study drug therapy up to Day 337, including up to 56 days after the last dose or up to the first dose of open-label, whichever occurred earlier|"All participants given study drug during the double-blind period (As Treated) where not evaluable was recorded for either low(monocytes, basophils and eosinophils) or high values(neutrophils)has been presented as 0.n=number of participants with evaluable results (each arm respectively)."||participants|||Number
707196|NCT00119678|Secondary|DB; Number of Participants With MAs in Hematology: Hemoglobin, Hematocrit, Erythrocytes and Platelet Count|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following hematology MA definitions specify the criteria for the data presented. Hemoglobin: >3 g/dL decrease from pre-treatment (pre-Rx) value; hematocrit: <0.75* pre-Rx value; erythrocyte count: <0.75* pre-Rx value; platelet count: <0.67* LLN or >1.5* ULN (or, if pre-Rx value <LLN, then <0.5* pre-Rx value or <100000/mm^3).|Events recorded at each participant encounter, from start of study drug therapy up to Day 337, including up to 56 days after the last dose or up to the first dose of open-label, whichever occurred earlier|"All participants given study drug during the double-blind period (As Treated) where not evaluable was recorded for high values (hemoglobin, hematocrit and erythrocytes)has been presented as 0. n=number of participants with evaluable results (each arm respectively)."||participants|||Number
707197|NCT00119678|Secondary|DB; Number of Participants With Significant AEs of Special Interest|An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition (even if not caused by the study drug). For this study, AEs of special interest were associated with the use of immunomodulatory agents. Number of participants with infections, malignant neoplasms, pre-specified autoimmune disorders, acute infusional AEs and peri-infusional AEs were recorded.|Events recorded at each participant encounter, from start of study drug therapy up to Day 337, including up to 56 days after the last dose or up to the first dose of open-label, whichever occurred earlier|"All participants given study drug during the double-blind period (As Treated).Participants grouped for randomized treatments, except where different treatment taken for entire double-blind period (which will instead be presented by first treatment actually received)."||participants|||Number
707210|NCT00121199|Secondary|Objective Response (Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR))|Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the SPD for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.|After Cycle 4 (Day 64) but prior to Cycle 5 (Day 85) and after Cycle 8 (Day 181). After completion of protocol treatment, every 6 months for 2 years, then annually for a maximum of five years.|All patients who started treatment were included in the analysis||participants|||Number
707198|NCT00119678|Secondary|DB; Number of Participants Who Died, Experienced AEs, Other SAEs or Discontinuations Due to AEs, Drug Related AEs|AEs: any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Drug-related AEs: events with a certain; probable; possible; or missing relationship to the study therapy. Participants who discontinued the study due to an AE were recorded.|Events recorded at each participant encounter, from start of study drug therapy up to Day 337, including up to 56 days after the last dose or up to the first dose of open-label, whichever occurred earlier|"All participants given study drug during the double-blind period (As Treated). The AEs represented here include SAEs, which are not included in the AE count represented in the AE xml upload section. As such, these numbers may not match."||participants|||Number
707199|NCT00119678|Secondary|DB; Number of Participants With a Change in the SLICC/ACR Damage Index at 1 Year Compared to Baseline|SLICC/ACR score or damage index is a measure of cumulative damage due to Systemic Lupus Erythematosus (SLE). Damage is defined as non-reversible change (not related to active inflammation) occurring since onset of lupus, ascertained by clinical assessment and present for at least 6 months. A score of 0=no damage, early damage is defined as ≥1. The total maximum score is 48, and increasing score indicates increasing disease severity.|From start of study drug treatment to Day 365|All randomized and treated participants who were available for analysis, grouped by the treatment randomized to (ITT).||participants|||Number
707200|NCT00119678|Secondary|DB; Median Number of Days to the First Occurrence of a New SLE Flare|Elapsed days between start of corticosteroid taper & first day of flare.Scored using BILAG:A:presence of =>1 serious;B:more moderate;C:mild symptomatic;D:prior activity,no current symptoms;E:organ that has never been involved.Calculated based on change during previous 4 weeks (1=improving,2=staying same,3=worsening,4=new).New SLE flare:first BILAG ‘A’ or ‘B’ event adjudicated to be flare following resolution of entry flare and/or start of corticosteroid taper.Inception treatment failure included (entry flare did not subside by Day 57/participant discontinued double-blind period before Day 29).|From start of corticosteroid taper to confirmation of disease flare or the end of double-blind period|All randomized and treated participants, grouped by the treatment randomized to (ITT).||Days||95% Confidence Interval|Median
707201|NCT00119678|Secondary|DB; Total Number of New SLE Flares Each Participant Experienced|SLE flares scored using BILAG:A:presence of =>1 serious;B:more moderate;C:mild symptomatic;D:prior activity,no current symptoms;E:organ that has never been involved.Calculated based on change during previous 4 weeks (1=improving,2=staying same,3=worsening,4=new).New SLE flare:BILAG ‘A’ or ‘B’ event adjudicated to be flare following resolution of entry flare and/or start of prednisone/prednisone-equivalent taper.Inception treatment failure included (entry flare did not subside by Day 57/participant discontinued double-blind period before Day 29).|From start of corticosteroid taper to Day 365|All randomized and treated participants, grouped by the treatment randomized to (ITT).||Participants|||Number
707202|NCT00119678|Secondary|DB; Number of Participants With a New SLE Flare During the Initial 6 Months|SLE flares scored using BILAG:A:presence of =>1 serious;B:more moderate;C:mild symptomatic;D:prior activity,no current symptoms;E:organ that has never been involved.Calculated based on change during previous 4 weeks (1=improving,2=staying same,3=worsening,4=new).New SLE flare:first BILAG ‘A’ or ‘B’ event adjudicated to be flare following resolution of entry flare and/or start of prednisone/prednisone-equivalent taper.Inception treatment failure included (entry flare did not subside by Day 57/participant discontinued double-blind period before Day 29).|From start of corticosteroid taper to 6 months.|All randomized and treated participants, grouped by the treatment randomized to (ITT).||Participants|||Number
707203|NCT00119678|Primary|Double Blind Period (DB); Number of Participants Experiencing a New SLE Flare|SLE flares scored using BILAG:A:presence of =>1 serious;B:more moderate;C:mild symptomatic;D:prior activity,no current symptoms;E:organ that has never been involved. Calculated based on change during previous 4 weeks (1=improving,2=staying same,3=worsening,4=new).New SLE flare:first BILAG ‘A’ or ‘B’ event adjudicated to be flare following resolution of entry flare and start of prednisone/prednisone-equivalent taper.Inception treatment failure included (entry flare did not subside by Day 57/participant discontinued double-blind period before Day 29).|From start of corticosteroid taper to Day 365|All randomized and treated participants, grouped by the treatment randomized to (Intent to Treat [ITT]). Participants who were inception treatment failures were treated as having 1 new flare; participants who discontinued early without any new flares were treated as having 1 new flare.||Participants|||Number
707204|NCT00121134|Primary|The Completion Rate of 1 Year of Bevacizumab Therapy for All Four Cohorts||1 year|||percentage of participants|||Number
707205|NCT00121186|Primary|Overall Survival|OS rate at 1 year.|1, 3, and 12 months after protocol treatment, then every 3 months for 1 year, every 6 months for year 2, then annually thereafter until 5 years after registration|||participants|||Number
707206|NCT00121186|Primary|Progression-free Survival|PFS rate at 1 year.|1, 3, and 12 months after protocol treatment, then every 3 months for 1 year, every 6 months for year 2, then annually thereafter until 5 years after registration|||participants|||Number
707207|NCT00121199|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment|Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.||Participants|||Number
707208|NCT00121199|Primary|Progression-free Survival at 2 Year|Measured from time of registration to date of of first observation of progression/relapse, or death due to any cause, or last contact date|0-2 years|All eligible patients who started treatment were included in the analysis||percentage of participants||95% Confidence Interval|Number
707209|NCT00121199|Primary|Progression-free Survival at 1 Year|Measured from time of registration to date of of first observation of progression/relapse, or death due to any cause, or last contact date|0-1 year|All eligible patients who started treatment were included in the analysis||percentage of participants||95% Confidence Interval|Number
707211|NCT00121225|Secondary|Effect of Vorinostat on Serum Levels of VEGF and b-FGF||Baseline, day 8 and day 15||||||
707220|NCT00121238|Primary|The Number of Patients With a PSA Decline of ≥50%|"To assess the rate of Prostate Specific Antigen response associated with EMD121974 therapy in patients with non-metastatic androgen-independent prostate cancer.
This measure defined as a drop in PSA of at least 50% from the final pre-treatment value."|Up to 5 years|Per protocol: of the 16 patients registered for this arm, 13 were analyzed. 1 patient lost eligibility due to disease progression, 2 others were censored from efficacy analysis because it was determined they were ineligible based on PSA requirements.||participants|||Number
707221|NCT00121472|Secondary|Post-transplant Survival|30 day and 1 year post transplant survival|30 days, 1 year|Patients (n=112) who recieved a cardiac transplant were followed at 30 day and 1 year post-transplant to determine if the device influenced post-transplant survival.||percentage of participants|||Number
707222|NCT00121472|Secondary|Reoperations|Additional surgery after the initial implant operation|continuous|The first consecutive 194 patients enrolled under the Pivotal Study Protocol (n=133) and the Continued Access Protocol (CAP, n=61) were analyzed when the last subject reached the 1 year followup point on September 14, 2007. Analysis was Intent To Treat (ITT).||Number of Events|||Number
707223|NCT00121472|Secondary|Six Minute Walk Test (6MWT)|The Six Minute Walk Test(6MWT)measures the distance that a patient can walk in a period of 6 minutes. The distance walked is measured in meters. This test measures the patients' functional status. The more meters a patient can walk over baseline indicates improvement in functional status.|baseline to 6 months|Mean change from baseline in 6MWT distance at Month 1, 3, and 6. Only patients alive, capable and willing to perform test are included.||meters||Standard Error|Mean
707224|NCT00121472|Secondary|Minnesota Living With Heart Failure Questionnaire (MLWHF)|MLWHF is a validated instrument to self assess how heart failure and its treatment affect the key physical, emotional, social and psychological dimensions of quality of life. The instrument is made up of 21 items that assess the patient's perception of these dimensions on a scale ranging from no (0) to very much (5). The total MLWHF score is calculated by adding the scores for all 21 items (range, 0-105). A lower score indicates a better quality of life. The patients' score at six months was compared to their baseline score and the resulting negative score indicates improved quality of life.|Baseline to 6 months|Patients alive and capable of performing the test at 6 months||units on a MLWHF Score scale||Standard Error|Mean
707225|NCT00121472|Secondary|New York Heart Association (NYHA) Classification|NYHA relates symptoms to every day activities and patients quality of life. Class 1 = no limitations on physical activity Class 2 - slight limitation of physical activity Class 3 - marked limitation of physical activity Class 4 = unable to carry out any physical activity without discomfort|baseline, 1 month, 3 months, 6 months|All patients who survived to interval are included.||units on NYHA scale||Full Range|Mean
707226|NCT00121472|Secondary|Kansas City Cardiomyopathy Questionaire (KCCQ)|KCCQ is a validated instrument to self assess quality of life including physical function and social function. The instrument provides two scores, the Overall Summary (OSS) and Clinical Summary (CSS). Scores are calculated based on responses to the questionnaire, on a scale from 0-100. The higher the score, the better the quality of life. The patients' scores at six months were compared to their baseline scores and the resulting positive scores indicated improved quality of life.|baseline to 6 months|Patients alive and capable of performing the test at 6 months||Units on a KCCQ Score scale||Standard Error|Mean
707227|NCT00121472|Secondary|Clinical Reliability (Malfunctions/Failures)|Confirmed malfunctions/Serious Adverse Events|continuous|||Number of Serious Events|||Number
707228|NCT00121472|Primary|Survival|Survival to cardiac transplantation or 180 days on left ventricular assist system (LVAS) support while remaining listed for cardiac transplantation as United Network for Organ Sharing (UNOS)status 1A or 1B (please refer to www.unos.org for complete definitions of status).|180 days|The first consecutive 194 patients enrolled under the Pivotal Study Protocol (n=133) and the Continued Access Protocol (CAP, n=61) were analyzed when the last subject reached the 1 year followup point on September 14, 2007. Analysis was Intent To Treat (ITT).||participants|||Number
707229|NCT00121485|Secondary|Neurocognitive Assessments, Trail Making B|This is a visual motor task measuring processing speed and executive functions. The patient is required to draw a line between alternating sequential numbers and letters while being timed to completion. Testing scores are time to completion in seconds with lower score being better.|Baseline (1 month), 6 months|Patients enrolled at 12 representative study sites participated in the neurocognitive testing. These study sites were selected based on their historic implant rates to represent high, medium and low enrolling centers.||Units measured in seconds||Full Range|Median
707230|NCT00121485|Secondary|Neurocognitive Assessments, Trail Making A|This is a visual motor task measuring processing speed. The patient is required to draw a line between sequential numbers while being timed to completion. The score is time to completion in seconds and lower score is better.|Baseline (1 month), 6 months|Patients enrolled at 12 representative study sites participated in the neurocognitive testing. These study sites were selected based on their historic implant rates to represent high, medium and low enrolling centers.||Units measured in seconds||Full Range|Median
707231|NCT00121485|Secondary|Wechsler Adult Intelligence Test-III, Digit Symbol (WAIS Digit)|The WAIS Digit is a measure of visual motor speed and abstracting ability. The patient is given the numbers one to nine with an associated symbol. Performance is scored on time with correct amount completed with a maximum of 133 points, where higher is better.|Baseline (1 month), 6 months|Patients enrolled at 12 representative study sites participated in the neurocognitive testing. These study sites were selected based on their historic implant rates to represent high, medium and low enrolling centers.||units on a scale||Full Range|Median
707232|NCT00121485|Secondary|Neurocognitive Assessments, Boston Naming Test|Fifteen pictures of objects are presented to the patient. The patient is asked to name the object without prompting. A Correct identification represents one point. This test is designed to test language. Scores are from 0-15, higher being better.|Baseline (1 month), 6 months|Patients enrolled at 12 representative study sites participated in the neurocognitive testing. These study sites were selected based on their historic implant rates to represent high, medium and low enrolling centers.||units on a scale||Full Range|Median
707233|NCT00121485|Secondary|Neurocognitive Assessments, Wechsler Adult Intelligence Test-III, Block Design (WAIS Block)|The WAIS block is a measure of visual spatial and visual motor ability. The patient is given a stimulus configuration to replicate with red and white blocks while being timed, first starting with four blocks and progressing to a nine block configuration. Performance is scored on time upon full completion of the task with a maximum of 68 points. The higher the score, the better.|Baseline (1 month), 6 months|Patients enrolled at 12 representative study sites participated in the neurocognitive testing. These study sites were selected based on their historic implant rates to represent high, medium and low enrolling centers.||units on a scale||Full Range|Median
707234|NCT00121485|Secondary|Neurocognitive Assessments, Wechsler Memory Scale-III Visual Reproduction (WMS-VR and WMS-VR Delayed)|The WMS-VR is a measure of visual memory. This is a graphic memory task requiring both immediate recall and after a 30 minute delay (WMS-VR Delayed). The scoring range is 0-104 where the higher score is better.|Baseline (1 month), 6 months|Patients enrolled at 12 representative study sites participated in the neurocognitive testing. These study sites were selected based on their historic implant rates to represent high, medium and low enrolling centers.||units on a scale||Full Range|Median
707235|NCT00121485|Secondary|Neurocognitive Assessments, Wechsler Memory Scale-III (WMS-LM and WMS-LM Delayed)|The WMS-LM is a measure of auditory attention and memory. This contextual memory task requires patients to recall a passage read by the examiner. Their memory tasks are avoided during the intervening time so as not to disrupt recall. The WMS-LM test provides a comparision for immediate recall and the WMS-LM Delayed provides a comparison for recall that is delayed 30 minutes. The test is scored in a range from 0-50, where the higher score is considered better|Baseline (1 month), 6 months|Patients enrolled at 12 representative study sites participated in the neurocognitive testing. These study sites were selected based on their historic implant rates to represent high, medium and low enrolling centers.||units on a scale||Full Range|Median
707236|NCT00121485|Secondary|Neurocognitive Assessments, Clock Drawing|Clock drawing is a measure of visual-spatial integrity, visual motor skills and organizational ability. The drawing was administered with the command version with no time restraint. The clock is scored from 1-10, with 10 a better score.|Baseline (1 month), 6 months|Patients enrolled at 12 representative study sites participated in the neurocognitive testing. These study sites were selected based on their historic implant rates to represent high, medium and low enrolling centers.||units on a scale||Full Range|Median
707237|NCT00121485|Secondary|Reoperations|The number of additional surgeries after the initial pump implant. Data is presented as the percentage of patients who required a reoperation for pump replacement or repair, bleeding or other reasons|Patients were followed until outcome or up to 2 years post-implant, whichever came first|||percentage of participants|||Number
707238|NCT00121485|Secondary|Functional Status (Patient Activity Score)|Metabolic Equivalent Score (METs). Ranges: Very Low, Low, Moderate, High, Very High|Baseline, Months 1, 3, 6, 12|Primary Study Cohort (As Treated)||percentage of participants|||Number
707239|NCT00121485|Secondary|Six Minute Walk Test (6MWT)|The Six Minute Walk Test(6MWT) measures the distance that a patient can walk in a period of 6 minutes. The distance walked is measured in meters. This test measures the patients' functional status. The more meters a patient can walk over baseline indicates improvement in functional status.|Baseline, Months 1, 3, 6, 12|Primary Study Cohort (As Treated)||Distance (meters)||Standard Deviation|Mean
707240|NCT00121485|Secondary|New York Heart Association (NYHA) Classification|NYHA relates symptoms to every day activities and patients quality of life. Class 1 = no limitations on physical activity Class 2 - slight limitation of physical activity Class 3 - marked limitation of physical activity Class 4 = unable to carry out any physical activity without discomfort|Baseline, Months 1, 6, 12|Primary Study Cohort (As Treated)||percentage of participants in each class|||Number
707241|NCT00121485|Secondary|Kansas City Cardiomyopathy Questionnaire (KCCQ)|KCCQ is a validated instrument to self assess quality of life including physical function and social function. Scores are calculated based on responses to the questionnaire, on a scale from 0-100. The higher the score, the better the quality of life. The patients' scores at Baseline, 1, 3, 6 and 12 Months are presented and indicate improved quality of life.|Baseline, Months 1, 3, 6, 12|Primary Study Cohort (As Treated)||Units on a KCCQ score scale||Standard Deviation|Mean
707242|NCT00121485|Secondary|Minnesota Living With Heart Failure Questionnaire(MLWHF)|MLWHF is a validated instrument to self assess how heart failure and its treatment affect the key physical, emotional, social and psychological dimensions of quality of life. The instrument is made up of 21 items that assess the patient's perception of these dimensions on a scale ranging from no (0) to very much (5). The total MLWHF score is calculated by adding the scores for all 21 items (range, 0-105). A lower score indicates a better quality of life. The patients' scores at Baseline, 1, 3, 6 and 12 Months post-implant are presented and indicate improved quality of life.|Baseline, Months 1,3,6,12|Primary Study Cohort (As Treated)||Units on a MLWHF Score scale||Standard Deviation|Mean
707243|NCT00121485|Primary|Composite Endpoint|Survival at two (2) years free of stroke, or reoperation to repair or replace the device|Patients' status at 2 years post-implant|Primary Study Cohort (Intent to Treat)||percentage of participants||95% Confidence Interval|Number
707510|NCT00123643|Primary|Flow Mediated Dilation|Measure of endothelial function|change from baseline to 6 months|All completers were analyzed||percent change||Standard Deviation|Mean
707511|NCT00123682|Secondary|Self-reported Quit Attempt||6 months|||percentage of participants|||Number
707512|NCT00123682|Secondary|Use of Cessation Medications||6 months|||percentage of participants|||Number
707304|NCT00121719|Other Pre-specified|Pharmacodynamic (PD) Biomarkers of Lenvatinib in Peripheral Blood Mononuclear Cells (PBMCs) and Tumor Samples|Blood samples were collected for isolation of Peripheral Blood Mononuclear Cells (PBMCs) immediately prior to the first dose and at 3 and 24 hours following the first dose of lenvatinib. The same collection schedule was repeated following the administration of lenvatinib on Day 29 (Cycle 2 Day 1). For participants in the food-effect pilot study blood samples were collected pre-dose, plus 3 hour and 24 hours PD samples were collected on Day 15 or Day 22. These participants were not required to give PD samples on Cycle 2 Day 1. Tumor tissue samples were collected from participants with tumors accessible to biopsy (optional study). Tissue samples were formalin-fixed then paraffin embedded according to a standard protocol. Once preclinical studies have identified possible PD biomarkers for the biological effect of lenvatinib in vivo, the samples taken from participants in this study are planned to be analyzed. No data was provided at this time.|Blood: Cycle 1 Day 1, Day 15, or Day 22, Cycle 2 Day 1 Tumor tissue: Screening and after at least one 28-day Cycle of study treatment||||||
707305|NCT00121719|Secondary|Effect of Food on Time to Maximum Concentration (Tmax) of Lenvatinib|Blood samples for PK analysis were collected at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 5, 8, and 24 hours after the first dose of lenvatinib and 24 hours after the first dose of lenvatinib on Day 15 and Day 22 of Cycle 1. Blood samples were not collected on Day 29, except for the pre-dose sample. The samples were analyzed for the amount of lenvatinib in the plasma using liquid chromatography-tandem mass spectrometry method of analysis. Plasma PK data were analyzed using a noncompartmental analysis approach to obtain individual participant estimates of Tmax, which was then summarized as the mean and standard deviation for all participants and expressed in hours.|Cycle 1 Day 1, Day 15, and Day 22|The Food Effect Population consisted of all subjects who agreed to participate in this part of the study, have received both the Day 15 and Day 22 doses, with PK sampling during 24 hours following those doses and consumed at least half (approximately) of the high fat breakfast when in the fed period.||Hours||Full Range|Median
707306|NCT00121719|Secondary|Effect of Food on the Maximum Plasma Concentration (Cmax) of Lenvatinib|Blood samples for PK analysis were collected at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 5, 8, and 24 hours after the first dose of lenvatinib and 24 hours after the first dose of lenvatinib on Day 15 and Day 22 of Cycle 1. Blood samples were not collected on Day 29, except for the pre-dose sample. The samples were analyzed for the amount of lenvatinib in the plasma using liquid chromatography-tandem mass spectrometry method of analysis. Plasma PK data were analyzed using a noncompartmental analysis approach to obtain individual participant estimates of Cmax, which was then summarized as the mean and standard deviation for all participants and expressed in nanograms/milliliter (ng/mL).|Cycle 1 Day 1, Day 15 and Day 22|The Food Effect Population consisted of all subjects who agreed to participate in this part of the study, have received both the Day 15 and Day 22 doses, with PK sampling during 24 hours following those doses and consumed at least half (approximately) of the high fat breakfast when in the fed period.||ng/mL||Standard Deviation|Mean
707307|NCT00121719|Secondary|Effect of Food on the Area Under the Curve From Zero to 24 Hours (AUC(0-24))|Blood samples for PK analysis were collected at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 5, 8, and 24 hours after the first dose of lenvatinib and 24 hours after the first dose of lenvatinib on Day 15 and Day 22 of Cycle 1. Blood samples were not collected on Day 29, except for the pre-dose sample. The samples were analyzed for the amount of lenvatinib in the plasma using liquid chromatography-tandem mass spectrometry method of analysis. Plasma PK data were analyzed using a noncompartmental analysis approach to obtain individual participant estimates of AUC(0-24), which was then summarized as the mean and standard deviation for all participants and expressed in nanograms*hours/milliliter (ng*hr/mL).|Cycle 1 Day 15 and Day 22|The Food Effect Population consisted of all subjects who agreed to participate in this part of the study, have received both the Day 15 and Day 22 doses, with PK sampling during 24 hours following those doses and consumed at least half (approximately) of the high fat breakfast when in the fed period.||ng*hr/mL||Standard Deviation|Mean
707331|NCT00122109|Secondary|PTSD Checklist-military Version (PCL-M)|Self report that measures severity of PTSD symptoms. The PCL-M measures the 17 cardinal symptoms of PTSD as described in the DSM-IV-TR. The scale ranges from 0 - 85 with higher scores indicating worse PTSD symptoms. PTSD symptoms were measured at baseline and post-treatment only.|Post-treatment (2 weeks following last treatment session)|||units on a scale||Standard Deviation|Mean
707351|NCT00122369|Primary|Pain Ratings at Specified Time Point During the Procedure|Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain|90 min|Patients remaining on procedure table. (Please note that the data in the hypnosis group encompass 4 data points since one patient did not indicate her anxiety level at that time point).||units on a scale||Inter-Quartile Range|Median
707308|NCT00121719|Secondary|Renal Clearance (CLr) of Lenvatinib|Blood samples were drawn immediately prior to the first dose of study drug, and at 15 and 30 minutes and at 1, 1.5, 2, 2.5, 3, 5, 8, and 24 hours after the first dose of lenvatinib. For participants who were not enrolled in the food-effect part of the study, the collection of blood samples was repeated following administration of lenvatinib on Day 29 (Cycle 2 Day 1). The samples were analyzed for the amount of lenvatinib in the plasma using liquid chromatography-tandem mass spectrometry method of analysis. Renal clearance was calculated as: Ae(0-24)/AUC(0-24) where Ae(0-24) is amount of unchanged lenvatinib recovered in 24 hours. Plasma PK data were analyzed using a noncompartmental analysis approach to obtain individual participant estimates of CLr, which was then summarized as the mean and standard deviation for all participants and expressed in liters/hour (L/hr).|Cycle 1 Day 1 (C1D1), Cycle 2 Day 1 (C2D1)|Pharmacokinetic population included all participants in the ITT/Safety population that had evaluable PK data in at least one treatment cycle.||L/hour||Standard Deviation|Mean
707309|NCT00121719|Secondary|Fraction of Unchanged Lenvatinib Excreted in the Urine (fe)|Urine aliquots were collected at 0 to 8, 8 to 16, and 16 to 24 hour intervals after administration of lenvatinib on Day 1 of Cycle 1 and Cycle 2, and then analyzed for the amount of lenvatinib using approved standardized methods. The samples were analyzed for the amount of lenvatinib in the urine using liquid chromatography-tandem mass spectrometry method of analysis. Urine PK data were analyzed using a noncompartmental analysis approach to obtain individual participant estimates of fe, which was then summarized as the mean and standard deviation for all participants and expressed in percentage of lenvatinib.|Cycle 1 Day 1 (C1D1), Cycle 2 Day 1 (C2D1)|Pharmacokinetic population included all participants in the ITT/Safety population that had evaluable PK data in at least one treatment cycle.||Percentage of lenvatinib||Standard Deviation|Mean
707310|NCT00121719|Secondary|Apparent Volume of Distribution (Vz/F)|Blood samples were drawn immediately prior to the first dose of study drug, and at 15 and 30 minutes and at 1, 1.5, 2, 2.5, 3, 5, 8, and 24 hours after the first dose of lenvatinib. For participants who were not enrolled in the food-effect part of the study, the collection of blood samples was repeated following administration of lenvatinib on Day 29 (Cycle 2 Day 1). The samples were analyzed for the amount of lenvatinib in the plasma using liquid chromatography-tandem mass spectrometry method of analysis. The apparent volume of distribution gives information about the amount of lenvatinib distributed in body tissue rather than the blood/plasma. Vz/F for parent lenvatinib only was calculated as Dose /[( λz)*( AUC0-inf)]. Plasma PK data were analyzed using a noncompartmental analysis approach to obtain individual participant estimates of Vz/F, which was then summarized as the mean and standard deviation for all participants and expressed in liters (L).|Cycle 1 Day 1 (C1D1), Cycle 2 Day 1 (C2D1)|Pharmacokinetic population included all participants in the ITT/Safety population that had evaluable PK data in at least one treatment cycle.||L||Standard Deviation|Mean
707311|NCT00121719|Secondary|Clearance Corrected for the Fraction of Lenvatinib Absorbed (CL/F)|Blood samples were drawn immediately prior to the first dose of study drug, and at 15 and 30 minutes and at 1, 1.5, 2, 2.5, 3, 5, 8, and 24 hours after the first dose of lenvatinib. For participants who were not enrolled in the food-effect part of the study, the collection of blood samples was repeated following administration of lenvatinib on Day 29 (Cycle 2 Day 1). The samples were analyzed for the amount of lenvatinib in the plasma using liquid chromatography-tandem mass spectrometry method of analysis. CL/F is the clearance for parent lenvatinib only and was calculated as Dose/[AUC0-inf]. Plasma PK data were analyzed using a noncompartmental analysis approach to obtain individual participant estimates of CL/F, which was then summarized as the mean and standard deviation for all participants and expressed in liters/hour (L/hr).|Cycle 1 Day 1 (C1D1), Cycle 2 Day 1 (C2D1)|Pharmacokinetic population included all participants in the ITT/Safety population that had evaluable PK data in at least one treatment cycle.||L/hr||Standard Deviation|Mean
707312|NCT00121719|Secondary|Area Under the Plasma Concentration Curve From Time 0 to 24 Hours (AUC(0-24))|Blood samples were drawn immediately prior to the first dose of study drug, and at 15 and 30 minutes and at 1, 1.5, 2, 2.5, 3, 5, 8, and 24 hours after the first dose of lenvatinib. For participants who were not enrolled in the food-effect part of the study, the collection of blood samples was repeated following administration of lenvatinib on Day 29 (Cycle 2 Day 1). The samples were analyzed for the amount of lenvatinib in the plasma using liquid chromatography-tandem mass spectrometry method of analysis. The area under the plasma concentration-time curve from time 0 to 24 hours, was calculated using the linear trapezoidal rule. Plasma PK data were analyzed using a noncompartmental analysis approach to obtain individual participant estimates of AUC(0-24), which was then summarized as the mean and standard deviation for all participants and expressed in ng*hr/mL.|Cycle 1 Day 1 (C1D1), Cycle 2 Day 1 (C2D1)|Pharmacokinetic population included all participants in the ITT/Safety population that had evaluable PK data in at least one treatment cycle.||ng*hr/mL||Standard Deviation|Mean
707313|NCT00121719|Secondary|Area Under the Plasma Concentration Curve From Time 0 to Infinity (AUC(0-inf))|Blood samples were drawn immediately prior to the first dose of study drug, and at 15 and 30 minutes and at 1, 1.5, 2, 2.5, 3, 5, 8, and 24 hours after the first dose of lenvatinib. For participants who were not enrolled in the food-effect part of the study, the collection of blood samples was repeated following administration of lenvatinib on Day 29 (Cycle 2 Day 1). The samples were analyzed for the amount of lenvatinib in the plasma using liquid chromatography-tandem mass spectrometry method of analysis. The area under the plasma concentration-time curve from time 0 to infinity (AUC0-inf) was calculated as AUC(0-t) + Ct / λz where Ct is the last measurable concentration. Plasma PK data were analyzed using a noncompartmental analysis approach to obtain individual participant estimates of AUC(0-inf), which was then summarized as the mean and standard deviation for all participants and expressed in nanograms*hours/milliliter (ng*hr/mL).|Cycle 1 Day 1 (C1D1), Cycle 2 Day 1 (C2D1)|Pharmacokinetic population included all participants in the ITT/Safety population that had evaluable PK data in at least one treatment cycle.||ng*hr/mL||Standard Deviation|Mean
707332|NCT00122109|Primary|Novaco Anger Scale (NAS)|Anger disposition was assessed using the total scale score from the Novaco Anger Scale. This 60-item measure (range = 60 - 180) is a well validated self-report instrument designed to measure cognitive, arousal, and behavioral aspects of anger in both clinical and non-patient populations. Higher scores indicate more anger-related symptoms.|6-Month Follow Up|||units on a scale||Standard Deviation|Mean
707352|NCT00122369|Primary|Pain Ratings at Specified Time Point During the Procedure|Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain|80 min|Patients remaining on procedure table||units on a scale||Inter-Quartile Range|Median
707314|NCT00121719|Secondary|Apparent Plasma Half-life (t1/2) of Lenvatinib|Blood samples were drawn immediately prior to the first dose of study drug, and at 15 and 30 minutes and at 1, 1.5, 2, 2.5, 3, 5, 8, and 24 hours after the first dose of lenvatinib. For participants who were not enrolled in the food-effect part of the study, the collection of blood samples was repeated following administration of lenvatinib on Day 29 (Cycle 2 Day 1). The samples were analyzed for the amount of lenvatinib in the plasma using liquid chromatography-tandem mass spectrometry method of analysis. The apparent plasma half-life was calculated as t1/2 = 0.693/λz where the apparent first order elimination rate constant (λz) was determined by the slope of the terminal log-linear phase of the plasma concentration-time curve. Plasma PK data were analyzed using a noncompartmental analysis approach to obtain individual participant estimates of t1/2, which was then summarized as the mean and standard deviation for all participants and expressed in hours.|Cycle 1 Day 1 (C1D1), Cycle 2 Day 1 (C2D1)|Pharmacokinetic population included all participants in the ITT/Safety population that had evaluable PK data in at least one treatment cycle.||Hours||Standard Deviation|Mean
707315|NCT00121719|Secondary|Time to Maximum Plasma Concentration (Tmax) of Lenvatinib|Blood samples were drawn immediately prior to the first dose of study drug, and at 15 and 30 minutes and at 1, 1.5, 2, 2.5, 3, 5, 8, and 24 hours after the first dose of lenvatinib. For participants who were not enrolled in the food-effect part of the study, the collection of blood samples was repeated following administration of lenvatinib on Day 29 (Cycle 2 Day 1). The samples were analyzed for the amount of lenvatinib in the plasma using liquid chromatography-tandem mass spectrometry method of analysis. Plasma PK data were analyzed using a noncompartmental analysis approach to obtain individual participant estimates of Tmax, which was then summarized as the mean and standard deviation for all participants and expressed in hours.|Cycle 1 Day 1 (C1D1), Cycle 2 Day 1 (C2D1)|Pharmacokinetic population included all participants in the ITT/Safety population that had evaluable PK data in at least one treatment cycle.||Hours||Standard Deviation|Mean
707316|NCT00121719|Secondary|Maximum Plasma Concentration (Cmax) of Lenvatinib|Blood samples were drawn immediately prior to the first dose of study drug, and at 15 and 30 minutes and at 1, 1.5, 2, 2.5, 3, 5, 8, and 24 hours after the first dose of lenvatinib. For participants who were not enrolled in the food-effect part of the study, the collection of blood samples was repeated following administration of lenvatinib on Day 29 (Cycle 2 Day 1). The samples were analyzed for the amount of lenvatinib in the plasma using liquid chromatography-tandem mass spectrometry method of analysis. Plasma pharmacokinetics (PK) data were analyzed using a noncompartmental analysis approach to obtain individual participant estimates of Cmax, which was then summarized as the mean and standard deviation for all participants and expressed as nanograms/milliliter (ng/mL).|Cycle 1 Day 1 (C1D1), Cycle 2 Day 1 (C2D1)|Pharmacokinetic population included all participants in the ITT/Safety population that had evaluable PK data in at least one treatment cycle.||ng/mL||Standard Deviation|Mean
707317|NCT00121719|Secondary|Best Overall Response (BOR)|BOR was the best confirmed response of complete response (CR), partial response (PR), progressive disease (PD), stable disease (SD), or not evaluable (NE), recorded from the start of lenvatinib until disease progression/recurrence or death. CR; disappearance of all target lesions for at least 1 month. PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD; a 20% or greater increase in the sum of the longest diameter of measured lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions. SD; PR failed to be achieved in the overall response assessment and there was no PD observed at 7 weeks or later after starting lenvatinib.|Baseline to first date of documented CR, PR, SD, or PD, assessed up to approximately 4 years|Intent-to-treat population included all participants who received at least one dose of lenvatinib.||Percentage of participants|||Number
707318|NCT00121719|Secondary|Treatment-Related Adverse Events (All Grades) With an Overall Incidence Greater Than or Equal to 10%|Treatment-related AEs were untoward medical events that were considered by the investigator to be possibly or probably related to lenvatinib.|First date of study treatment to date of withdrawal from study or last dose of study treatment, up to approximately 4 years|Safety population (ITT population) included all participants who took at least one dose of lenvatinib.||Percentage of participants|||Number
707319|NCT00121719|Secondary|Dose-limiting Toxicities (DLTs)|A DLT was defined as any grade 3 or higher hematological or non-hematological toxicity directly related to lenvatinib, any repeated National Cancer Institute Common Toxicity Criteria (NCI CTC) grade 2 hematological or non-hematological toxicity considered to be directly related to lenvatinib and required dose reduction, or failure to administer greater than or equal to 75% of the planned dosage of lenvatinib during Cycle 1 as a result of treatment-related failure.|Cycle 1 (4 weeks) of each dose level|Intention to Treat (ITT)/Safety population included all subjects who received at least one dose of lenvatinib.||Participants|||Number
707320|NCT00121719|Secondary|Summary of Adverse Events (AEs) and Serious Adverse Events (SAEs)|AEs were collected from the signing of the informed consent form until the date the participant was withdrawn from the study. All AEs were graded on a 5-point scale according to the National Cancer Institute's Common Toxicity Criteria (NCI CTC) grading system, version 3.0. Safety was assessed using the occurrence of DLTs, AEs, SAEs, clinical laboratory test results, vital signs measurements, physical examination findings, and electrocardiograms (ECGs) readings. An AE was defined as any untoward medical occurrence in a participant administered lenvatinib and did not necessarily have a causal relationship to lenvatinib. An SAE was defined as any untoward medical occurrence which results in death, was life-threatening, required hospitalization or prolonged hospitalization, resulted in persistent or significant disability/incapacity, or caused a congenital anomaly/birth defect. Treatment-related AEs and SAEs are AEs considered probably or possibly related to lenvatinib.|First date of study treatment to date of last dose of study treatment, up to approximately 4 years|Safety population (ITT population) included all participants who received at least one dose of lenvatinib.||Percentage of participants|||Number
707321|NCT00121719|Primary|Maximum Tolerated Dose (MTD)|The MTD was defined as the highest dose level at which no more than one out of six participants experienced dose-limiting toxicity (DLT). DLT was assessed during the first 4 weeks of therapy (Cycle 1) for dose escalation purposes. Participants enrolled into the MTD cohort were given the option to also participate in the food-effect pilot study. The food-effect pilot study was initiated once the MTD had been established.|Cycle 1 (4 weeks)|Intent-to-treat population included all participants who received at least one dose of lenvatinib.||mg|||Number
707513|NCT00123682|Primary|7-day Point Prevalence Abstinence From Smoking||6 month|||percentage of participants|||Number
707322|NCT00121810|Secondary|Mean Percent Change in Calculated Glomerular Filtration Rate From Baseline to Months 6, 12, and 24 (Nankivell Equation)|"Renal allograft function determined by mean percent change from baseline in calculated Glomerular Filtration Rate (Nankivell equation) by treatment group at 6, 12, and 24 months postrandomization.
percent change= [(calculated Glomerular Filtration Rate at Month t - calculated Glomerular Filtration Rate at baseline)/calculated Glomerular Filtration Rate at baseline]*100 percent, where t=6, 12, and 24 months postrandomization."|baseline, 6, 12, and 24 months|Intent-to-treat population. Analysis population (AP) at Baseline: Mycophenolate mofetil (MMF) + sirolimus = 148, MMF + cyclosporine or tacrolimus (CNI) = 151; AP at Month 6: MMF+sirolimus = 117, MMF+CNI = 130; AP at Month 12: MMF+sirolimus = 123, MMF+CNI = 123; AP at Month 24: MMF+sirolimus = 120, MMF+CNI = 116.||percent change||Standard Deviation|Mean
707323|NCT00121810|Secondary|Mean Percent Change in Calculated Creatinine Clearance From Baseline to Months 6, 12, and 24|"Renal allograft function determined by mean percent change from baseline in calculated creatinine clearance (Cockroft and Gault method) by treatment group at 6, 12, and 24 months postrandomization.
percent change= [(calculated creatinine clearance at Month t - calculated creatinine clearance at baseline)/calculated creatinine clearance at baseline]*100 percent, where t=6, 12, and 24 months postrandomization"|baseline 6, 12, and 24 months|Intent-to-treat population. Analysis population (AP) at Baseline: Mycophenolate mofetil (MMF) + sirolimus = 148, MMF + cyclosporine or tacrolimus (CNI) = 151; AP at Month 6: MMF+sirolimus = 117, MMF+CNI = 129; AP at Month 12: MMF+sirolimus = 124, MMF+CNI = 123; AP at Month 24: MMF+sirolimus = 120, MMF+CNI = 116.||percent change||Standard Deviation|Mean
707324|NCT00121810|Secondary|Mean Percent Change in Serum Creatinine From Baseline to Months 6, 12, and 24|"Renal allograft function determined by mean percent change from baseline in serum creatinine by treatment group at 6, 12, and 24 months postrandomization.
percent change= [(serum creatinine at Month t-serum creatinine at baseline)/serum creatinine at baseline]*100 percent, where t=6, 12, and 24 months postrandomization."|baseline, 6, 12, and 24 months|Intent-to-treat population. Analysis population (AP) at Baseline: Mycophenolate mofetil (MMF) + sirolimus = 148, MMF + cyclosporine or tacrolimus (CNI) = 151; AP at Month 6: MMF+sirolimus = 117, MMF+CNI = 130; AP at Month 12: MMF+sirolimus = 124, MMF+CNI = 123; AP at Month 24: MMF+sirolimus = 120, MMF+CNI = 116.||percent change||Standard Deviation|Mean
707325|NCT00121810|Secondary|Mean Percent Change in Glomerular Filtration Rate From Baseline to Month 24|"A secondary efficacy endpoint was mean percent change in renal function from baseline to 24 months postrandomization, as measured by Glomerular Filtration Rate utilizing renal clearance of cold iothalamate.
percent change= [(Glomerular Filtration Rate at Month 24-Glomerular Filtration Rate at baseline)/Glomerular Filtration Rate at baseline]*100 percent."|Baseline to 24 months|Intent-to-treat population. Analysis population (AP) at Baseline: Mycophenolate mofetil (MMF) + sirolimus = 148, MMF + cyclosporine or tacrolimus (CNI) = 151; AP at Month 24: MMF+sirolimus = 115, MMF+CNI = 105.||percent change||Standard Deviation|Mean
707326|NCT00121810|Primary|Mean Percent Change in Glomerular Filtration Rate From Baseline to Month 12|"The primary efficacy endpoint was mean percent change in renal function from baseline to 12 months postrandomization, as measured by Glomerular Filtration Rate utilizing renal clearance of cold iothalamate.
percent change= [(Glomerular Filtration Rate at Month 12-Glomerular Filtration Rate at baseline)/Glomerular Filtration Rate at baseline]*100 percent."|baseline to 12 months|Intent-to-treat population. Analysis population (AP) at Baseline: Mycophenolate mofetil (MMF) + sirolimus = 148, MMF + cyclosporine or tacrolimus (CNI) = 151; AP at Month 12: MMF+sirolimus = 120, MMF+CNI = 111.||percent change||Standard Deviation|Mean
707327|NCT00121836|Secondary|Number of Participants With Marked Laboratory Abnormalities|The secondary outcome measure was to evaluate the safety profile, including a summary of marked laboratory abnormalities in >= 5% of patients. n=number of participants with the laboratory measure,Number=number of participants with the abnormality. Laboratory values were flagged as Low(L) or High(H) if they were below the lower limit or above the upper limit of Roche standard reference range, respectively. Marked laboratory abnormalities (flagged as HH and LL) were defined as those values that were outside the Roche marked reference range and showed a clinically relevant change from baseline.|until progressive disease or for up to 3 years|109 patients (pts) received study drug in the First Study Treatment Phase. 54 pts withdrew prematurely, and 54 pts proceeded to the Second Study Treatment Phase. All 54 pts who proceeded to the Second Study Treatment Phase withdrew during that phase. 1 pt continued treatment in the First Study Treatment Phase and completed 3 years of follow-up.||Participants|||Number
707328|NCT00121836|Secondary|Premature Withdrawal From Study Due to Adverse Events|The secondary outcome measure was to evaluate the safety profile, including a summary of premature withdrawals due to adverse events occurring in more than 1 patient in either study group, by system organ class.|Throughout study|109 patients (pts) received study drug in the First Study Treatment Phase. 54 pts withdrew prematurely, and 54 pts proceeded to the Second Study Treatment Phase. All 54 pts who proceeded to the Second Study Treatment Phase withdrew during that phase. 1 pt continued treatment in the First Study Treatment Phase and completed 3 years of follow-up.||Participants|||Number
707329|NCT00121836|Secondary|Number of Subjects With Adverse Events|"The secondary outcome measure was to evaluate the safety profile, including a summary of adverse events (AEs) assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0.
Intensity of AEs were graded according to NCI CTCAE version 3.0 on a 5-point scale: Grade 1=Mild Discomfort, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life Threatening/Disabling and Grade 5=Death. An SAE was defined as any experience that suggested a significant hazard,contraindication, side effect, or precaution."|Throughout study|109 patients (pts) received study drug in the First Study Treatment Phase. 54 pts withdrew prematurely, and 54 pts proceeded to the Second Study Treatment Phase. All 54 pts who proceeded to the Second Study Treatment Phase withdrew during that phase. 1 pt continued treatment in the First Study Treatment Phase and completed 3 years of follow-up.||Participants|||Number
707330|NCT00121836|Primary|Overall Survival|Overall survival was defined as the time from date of first treatment dose (Day 1) to date of death, across the study phases regardless of the cause of death|approximately 505 days (Median Time to Death)|109 patients (pts) received study drug in the First Study Treatment Phase. 54 pts withdrew prematurely, and 54 pts proceeded to the Second Study Treatment Phase. All 54 pts who proceeded to the Second Study Treatment Phase withdrew during that phase. 1 pt continued treatment in the First Study Treatment Phase and completed 3 years of follow-up.||Days||95% Confidence Interval|Median
707514|NCT00123734|Secondary|To Provide Estimates of the Sensitivity and Specificity of [99mTc] ThromboView® for DVT at the 1-hour and 3-hour Imaging Time Points||May 2007||||||
707333|NCT00122109|Primary|Novaco Anger Scale (NAS)|Anger disposition was assessed using the total scale score from the Novaco Anger Scale. This 60-item measure (range = 60 - 180) is a well validated self-report instrument designed to measure cognitive, arousal, and behavioral aspects of anger in both clinical and non-patient populations. Higher scores indicate more anger-related symptoms.|3-Month Follow Up|||units on a scale||Standard Deviation|Mean
707334|NCT00122109|Primary|Novaco Anger Scale (NAS)|Anger disposition was assessed using the total scale score from the Novaco Anger Scale. This 60-item measure (range = 60 - 180) is a well validated self-report instrument designed to measure cognitive, arousal, and behavioral aspects of anger in both clinical and non-patient populations. Higher scores indicate more anger-related symptoms.|Post-treatment (2 weeks following last treatment session)|||units on a scale||Standard Deviation|Mean
707335|NCT00122109|Primary|Novaco Anger Scale (NAS)|Anger disposition was assessed using the total scale score from the Novaco Anger Scale. This 60-item measure (range = 60 - 180) is a well validated self-report instrument designed to measure cognitive, arousal, and behavioral aspects of anger in both clinical and non-patient populations. Higher scores indicate more anger-related symptoms.|Baseline|||units on a scale||Standard Deviation|Mean
707336|NCT00122109|Primary|State-Trait Anger Inventory (STAXI-2) Anger Expression Subscale|Anger expression was measured using the STAXI-2’s 32-item Anger Expression Index (range 0 - 96). The STAXI-2 subscale have robust psychometric properties including high internal consistency, external validity, and construct validity. The Anger Expression Index provides a general measure of anger expression; assessing one's experience, expression and efforts to control anger. Higher scores indicate more problematic levels of anger and its expression.|6-month Follow Up|||units on a scale||Standard Deviation|Mean
707337|NCT00122109|Primary|State-Trait Anger Inventory (STAXI-2) Anger Expression Subscale|Anger expression was measured using the STAXI-2’s 32-item Anger Expression Index (range 0 - 96). The STAXI-2 subscale have robust psychometric properties including high internal consistency, external validity, and construct validity. The Anger Expression Index provides a general measure of anger expression; assessing one's experience, expression and efforts to control anger. Higher scores indicate more problematic levels of anger and its expression.|3-month Follow Up|||units on a scale||Standard Deviation|Mean
707338|NCT00122109|Secondary|PTSD Checklist-military Version (PCL-M)|Self report that measures severity of PTSD symptoms. The PCL-M measures the 17 cardinal symptoms of PTSD as described in the DSM-IV-TR. The scale ranges from 0 - 85 with higher scores indicating worse PTSD symptoms. PTSD symptoms were measured at baseline and post-treatment only.|Baseline|||units on a scale||Standard Deviation|Mean
707339|NCT00122109|Primary|State-Trait Anger Inventory (STAXI-2) Anger Expression Subscale|Anger expression was measured using the STAXI-2’s 32-item Anger Expression Index (range 0 - 96). The STAXI-2 subscale have robust psychometric properties including high internal consistency, external validity, and construct validity. The Anger Expression Index provides a general measure of anger expression; assessing one's experience, expression and efforts to control anger. Higher scores indicate more problematic levels of anger and its expression.|Post-treatment (2 weeks following last treatment session)|||units on a scale||Standard Deviation|Mean
707340|NCT00122109|Primary|State-Trait Anger Inventory (STAXI-2) Anger Expression Index|Anger expression was measured using the STAXI-2’s 32-item Anger Expression Index (range 0 - 96). The STAXI-2 subscale have robust psychometric properties including high internal consistency, external validity, and construct validity. The Anger Expression Index provides a general measure of anger expression; assessing one's experience, expression and efforts to control anger. Higher scores indicate more problematic levels of anger and its expression.|Baseline|||units on a scale||Standard Deviation|Mean
707341|NCT00122135|Primary|Presence of Discussions About End of Life Care Goals/Wishes|Qualitative content analysis of physician-patient encounters regarding presence of any type of discussion about end of life care goals/wishes|immediate|||participants|||Number
707342|NCT00122187|Primary|Percent of Patients Receiving GI Consult Plus Anatomic Workup for FOBT+ Results|Percent of patients receiving GI consult plus anatomic workup within 30, 90, and 180 days of FOBT+ results|6 months|Sites that completed the intervention and post-intervention data collection were included in the analysis||percent patients with GI consult+workup|||Number
707343|NCT00122187|Primary|Percent of Patients Receiving GI Consult for FOBT+ Results|Percent of patients receiving GI consult within 30, 90, and 180 days of FOBT+ results|6 months|Sites that completed the intervention and post-intervention data collection were included in the analysis||percent patients receiving GI consult|||Number
707344|NCT00122317|Secondary|Quality of Life as Measured by FACIT-F SCALE||from first infusion to last infusion in this study||||||
707345|NCT00122317|Secondary|Hemolysis as Measured by LDH Area Under the Curve||from first infusion to last infusion in this study||||||
707346|NCT00122317|Secondary|Incidence of Thrombosis||from first infusion to last infusion in this study||||||
707347|NCT00122317|Primary|Incidence of Treatment-emergent Adverse Events||time of consent through 30 days after last study drug dose|||Participants|||Count of Participants
707348|NCT00122369|Primary|Time Trends of Pain Experience|Ordinal regression analysis looks at data as a series of possible splits of patient responses and assesses the odds of experiencing a value at or above as compared to the split; e.g. the probability of experiencing self-reported pain scores of 0 vs 1-10; 0-2 vs 3-10 ; 0-4 vs 5-10 etc with pain scores reported between 0=no pain, and 10=worst possible pain. The summary analysis with logit slopes gives in the time trend estimate the cumulative probabilities of the response categories over the variable N=procedure time (min). Positive slopes indicate increasing scores above the split point over time, negative slopes indicate decreasing scores, and flat lines no significant change. In the proportional odds model, an encompassing slope - a probability function of linear trend - is generated that not only applies to the logit forms of the individual splits but to the logic forms of graphs that portray all other splits. The resultant slopes then facilitate comparison among groups.|0-110 min|Intent to Treat; patients undergoing breast biopsy||logit slopes|||Number
707349|NCT00122369|Primary|Pain Ratings at Specified Time Point During the Procedure|Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain|110 min|Patients remaining on procedure table||units on a scale||Inter-Quartile Range|Median
707350|NCT00122369|Primary|Pain Ratings at Specified Time Point During the Procedure|Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain|100 min|Patients remaining on procedure table||units on a scale||Inter-Quartile Range|Median
707360|NCT00122369|Primary|Pain Ratings at Specified Time Point During the Procedure|Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain|0 min|Intent to Treat; patients on procedure table. (Please note that the data in the empathy group encompass 81 data points since one patient did not indicate her pain level at that time point).||units on a scale||Inter-Quartile Range|Median
707361|NCT00122369|Primary|Time Trends of Anxiety Experience|Ordinal regression analysis looks at data as a series of possible splits of patient responses and assesses the odds of experiencing a value at or above as compared to the split; e.g. the probability of experiencing self-reported anxiety scores of 0 vs 1-10; 0-2 vs 3-10 ; 0-4 vs 5-10 etc with anxiety scores reported between 0=no anxiety and 10=worst possible anxiety. The summary analysis with logit slopes gives in the time trend estimate the cumulative probabilities of the response categories over the variable N=procedure time (min). Positive slopes indicate increasing scores above the split point over time, negative slopes indicate decreasing scores, and flat lines no significant change. In the proportional odds model, an encompassing slope - a probability function of linear trend - is generated that not only applies to the logit forms of the individual splits but to the logic forms of graphs that portray all other splits. The resultant slopes then facilitate comparison among groups.|0-110 min|Intent to Treat; patients undergoing breast biopsy||logit slopes|||Number
707362|NCT00122369|Primary|Anxiety Ratings at Specified Time Point During the Procedure|Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety|110 min|Patients remaining on procedure table||units on a scale||Inter-Quartile Range|Median
707363|NCT00122369|Primary|Anxiety Ratings at Specified Time Point During the Procedure|Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety|100 min|Patients remaining on procedure table||units on a scale||Inter-Quartile Range|Median
707364|NCT00122369|Primary|Anxiety Ratings at Specified Time Point During the Procedure|Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety|90 min|Patients remaining on procedure table (please note that the data in the hypnosis group encompass only 4 patients since the 5th patient did not indicate her anxiety level at that time point)||units on a scale||Inter-Quartile Range|Median
707365|NCT00122369|Primary|Anxiety Ratings at Specified Time Point During the Procedure|Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety|80 min|Patients remaining on procedure table||units on a scale||Inter-Quartile Range|Median
707366|NCT00122369|Primary|Anxiety Ratings at Specified Time Point During the Procedure|Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety|70 min|Patients remaining on procedure table||units on a scale||Inter-Quartile Range|Median
707367|NCT00122369|Primary|Anxiety Ratings at Specified Time Point During the Procedure|Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety|60 min|Patients remaining on procedure table||units on a scale||Inter-Quartile Range|Median
707368|NCT00122369|Primary|Anxiety Ratings at Specified Time Point During the Procedure|Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety|50 min|Patients remaining on procedure table||units on a scale||Inter-Quartile Range|Median
707369|NCT00122369|Primary|Anxiety Ratings at Specified Time Point During the Procedure|Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety|40 min|Patients remaining on procedure table||units on a scale||Inter-Quartile Range|Median
707370|NCT00122369|Primary|Anxiety Ratings at Specified Time Point During the Procedure|Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety|30 min|Patients remaining on procedure table||units on a scale||Inter-Quartile Range|Median
707371|NCT00122369|Primary|Anxiety Ratings at Specified Time Point During the Procedure|Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety|20 min|Patients remaining on procedure table||units on a scale||Inter-Quartile Range|Median
707372|NCT00122369|Primary|Anxiety Ratings at Specified Time Point During the Procedure|Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety|10 min|Patients remaining on procedure table||units on a scale||Inter-Quartile Range|Median
707373|NCT00122369|Secondary|Impact of Event Scale (IES-15)|"The IES is a measure of subjective distress for any specific life event. This 15-item self-report instrument is used to assess experiences of intrusive thoughts (Intrusion subscale) and attempts to consciously avoid such experiences (Avoidance subscale) that are commonly associated with subjective distress about life situations. Answers are given in four ratings from not at all (score 0) to often (score 5), with a possible TOTAL overall range of scores from zero to 75.
≥26 indicates moderate to severe distress) of women who at the time of return for breast surgery after their initial biopsy"|Patients were followed for up to 3 weeks after their biopsy until the time of their surgery|These 19 patients were the only ones who could be captured for their return to surgery after their initial biopsy.||Scores on a Scale||Standard Deviation|Mean
707374|NCT00122369|Secondary|Salivary Cortisol Secretion|Secretion of cortisol over time is customarily described in terms of a slope with the time of day of cortisol measurement as the x variable and the natural logarithm of the measured cortisol concentration as the y variable. Cortisol slope is expressed as the natural logarithm of cortisol (micrograms per deciliter) per hour, with 1g/dL corresponding to 27.8 nmol/L. In general, greater negative slopes (with steeper decreases from high morning values to low evening values) are considered better adapted and healthier than flatter (less negative) slopes.|Patients were followed for the 5 days following their breast biopsy|Women learned their diagnosis between Day 1 and 6 (mean day 2.4). Analysis was truncated at day 5 when sufficient numbers of patients for meaningful analysis were available in each group: 16 in the “known malignant” group, 37 in the “known benign” group, and 73 in the “uncertain group” totaling 126 patients.||ln (microgram/dL)/hr||95% Confidence Interval|Mean
707375|NCT00122369|Primary|Anxiety Ratings at Specified Time Point During the Procedure|Self-reported anxiety on a scale of 0-10 with 0=no anxiety to 10=worst possible anxiety. Patients self-reported anxiety at the beginning (time 0), every 10 minutes, and at the end of their biopsy procedure on a 0-10 numeric verbal anxiety scale (0=no anxiety at all, 10=worst possible anxiety). Participants were followed for the duration of the biopsy procedure, an average of 43 min.|0 min|Intention to Treat; patients on procedure table||units on a scale||Inter-Quartile Range|Median
707515|NCT00123734|Secondary|To Provide Estimates of the Sensitivity of [99mTc] ThromboView® for Imaging Suspected Distal Initial DVT||May 2007|Number of participants with suspected initial DVT with evaluable images||% Sensitivity||95% Confidence Interval|Mean
707376|NCT00122382|Secondary|Number of Participants With Laboratory Values Meeting the Marked Abnormality Criteria During the Double-blind Period|Number of participants with laboratory values (hematology, liver and kidney functions, electrolytes, glucose tests, protein tests, metabolite tests, and urine chemistry tests) considered markedly abnormal according to prespecified protocol criteria|Includes data up to 56 days post the last dose in the double-blind period or start of the open-label period, whichever occurred first.|All treated in the DB period. n=Number of participants evaluated for this measure.||participants|||Number
707377|NCT00122382|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Reported During the Double-blind Period|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Related AE/SAE=Certain, Probable, Possible, or Missing. SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.|Includes data up to 56 days post the last dose in the double-blind period or start of the open-label period, whichever occurred first.|All treated participants in the Double-Blind period||participants|||Number
707378|NCT00122382|Secondary|Mean Difference Observed in Change From Baseline to Month 12 and Between Month 12 and Month 24 in Radiographic Scores (Total Score)|Mean difference observed in change from baseline to Month 12 and between Month 12 and Month 24 in radiographic scores (Total Score). To assess joint damage, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions and JSN. The total Genant-modified Sharp score ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145). Higher scores indicated more damage.|Baseline, Month 12, Month 24|Analysis includes all treated participants in the open-label period originally randomized to abatacept. Analysis includes all participants with observed assessments collected at Baseline (Day 1), Day 365 (Month 12), and Day 729 (Month 24)||units on a scale||Standard Error|Mean
707379|NCT00122382|Secondary|Number of Participants Without Radiographic Progression (as Measured by in Erosion Scores, JSN Scores, and Total Scores) at Month 24 in Participants Without Progression at Month 12|Participants with no radiographic progression ((defined as change in score <=0 or <=0.5), sustained from Month 12 and Month 24. To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions and JSN. The total Genant-modified Sharp score ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145). Higher scores indicated more damage.|Month 12, Month 24|Number of Participants Analyzed=All treated participants in the open-label period. (Treatment groups represent treatment received in the double-blind period.) n=the number of subjects with observed data included in the analysis.||Participants|||Number
707380|NCT00122382|Secondary|Number of Participants Without Radiographic Progression (as Measured by in Erosion Scores, JSN Scores, and Total Scores) From Baseline at Month 24|Participants with no radiographic progression (defined as change in score <=0 or <=0.5), from baseline to Month 24. To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions and JSN. The total Genant-modified Sharp score ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145). Higher scores indicated more damage.|Baseline, Month 24|All treated participants in the open-label period. Treatment groups represent treatment received in the double-blind period.||Participants|||Number
707381|NCT00122382|Primary|Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria During the Open-Label Period|Marked abnormalities in hemoglobin >3 g/dL decrease from PRE-RX; hematocrit <0.75x PRE-RX; erythrocytes <0.75x PRE-RX; platelet count <0.67x lower limit of normal (LLN) or >1.5x ULN or if PRE-RX <LLN then <0.5x PRE-RX and <100,000/mm3; leukocytes <0.75x LLN or >1.25x ULN or if PRE-RX <LLN then <0.8x PRE-RX or >ULN if PRE-RX >ULN then >1.2x PRE-RX or <LLN; neutrophils if value <1.00 x10^3 c/uL; lymphocytes if value <.750 x10^3 c/uL or if value >7.50 x10^3 c/uL; monocytes if value >2000/MM3; basophils if value >400/mm3; eosinophils if value >.750 x10^3 c/uL|Continuously from start of open-label period up to 56 days post the last dose in the open-label period or start of the maintenance sub-study, whichever occurred first.|All participants treated during the open-label period; n= number of participants evaluated for this measure.||participants|||Number
707382|NCT00122382|Primary|Number of Participants With Select Blood Chemistry Laboratory Values Meeting the Marked Abnormality Criteria During the Open-Label Period|Number of subjects with high liver function and kinedy tests: alkaline phosphatase (ALP) >2x upper limit of normal (ULN) or if pretreatment (PRE-RX) >ULN then >3x PRE-RX; aspartate aminotransferase (AST) >3x ULN or if PRE-RX >ULN then >4x PRE-RX; alanine aminotransferase (ALT) >3x ULN or if PRE-RX >ULN then >4x PRE-RX; g-glutamyl transferase (GGT)>2x ULN or if PRE-RX >ULN then >3x PRE-RX; total bilirubin >2x ULN or if PRE-RX >ULN then >4x PRE-RX; blood urea nitrogen >2x PRE-RX; creatinine >1.5x PRE-RX.|Continuously through open-label period (from Month 12 to Month 24). Includes data up to 56 days post last dose in the open-label period or start of the maintenance sub-study, whichever occurred first.|All Treated participants in the Open-label Period; n=number of participants evaluated for this measure.||participants|||Number
707383|NCT00122382|Primary|Number of Participants With a Serious Acute-Infusional AE of Anaphylactic Shock During Open-Label Period|There were 107 Prespecified, acute-infusional SAEs (occurring within 1 hour after the start of study drug infusion) pre-specified in the protocol; anaphylactic shock was the only one occuring in this study.|Open-Label Period (Month 12 to Month 24)|All participants treated during the Open-Label period.||Participants|||Number
707384|NCT00122382|Primary|Incidence Rates of Malignant Neoplasm Adverse Events in ABA-Treated Participants|The incidence rates of malignant neoplasms are defined as the (number of patients experiencing the event /exposure within the period)*100 and are expressed in 100 person-years. Subjects experiencing the event had their exposure censored at the time of the 1st event.|Double Blind Period (+56 days post last dose in double-blind period or start of the open-label period, whichever came first). Open-label period (56 days post last dose in open-label period or start of maintenance sub-study, whichever came first).|All subjects who received at least 1 dose of abatacept. Double-blind (DB) period: all treated in DB period; Open-label (OL) Period: all treated in OL period.||number of patients/100 patient-years|||Number
707385|NCT00122382|Primary|Incidence Rates of Infections and Infestations of Adverse Events in ABA-Treated Participants|The incidence rates of infections and infestations are defined as the (number of patients experiencing the event /exposure within the period)*100 and are expressed in 100 person-years. Subjects experiencing the event had their exposure censored at the time of the 1st event.|Double Blind Period (+56 days post last dose in double-blind period or start of the open-label period, whichever came first). Open-label period (56 days post last dose in open-label period or start of maintenance sub-study, whichever came first).|All subjects who received at least 1 dose of abatacept. Double-blind (DB) period: all treated in DB period; Open-label (OL) Period: all treated in OL period.||Number of patients/100 patient-years|||Number
707386|NCT00122382|Primary|Incidence Rates of Autoimmune Disorders in ABA-Treated Participants|The incidence rates of autoimmune disorders are defined as the (number of patients experiencing the event/exposure within the period)*100 and are expressed in 100 person-years. Subjects experiencing the event had their exposure censored at the time of the 1st event.|Double Blind Period (+56 days post last dose in double-blind period or start of open-label period, whichever came first). Open-label period (56 days post last dose in the open-label period or start of maintenance sub-study, whichever came first).|All subjects who received at least 1 dose of abatacept. Double-blind (DB) period: all treated in DB period; Open-label (OL) Period: all treated in OL period.||Number of participants/100 patient-years|||Number
707387|NCT00122382|Primary|Number of Participants With SAEs With an Outcome of Death During the Open-label Period|Any untoward medical occurrence (SAE) that resulted in death|Continuously through open-label period (from Month 12 to Month 24). Includes data up to 56 days post last dose in the open-label period or start of the maintenance sub-study, whichever occurred first.|All subjects who received at least 1 dose of ABA in the open-label period were included in the safety analyses.||participants|||Number
707388|NCT00122382|Secondary|Mean Change From Baseline in Radiographic Total, Erosion and JSN Scores to Month 24|To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions and JSN. The total Genant-modified Sharp score ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145). Higher scores indicated more damage. Change from baseline = Postbaseline - baseline value.|Baseline, Month 24|All treated participants in the open-label period. Because the analysis was change from baseline, only those with baseline and post-baseline were included. Linear extrapolation imputation was applied. Treatment groups represent treatment received in the double-blind period.||units on a scale||Standard Deviation|Mean
707389|NCT00122382|Secondary|Number of Participants With Health Assessment Questionnaire (HAQ) Response at Month 24|Physical function was evaluated using the HAQ-disability index (HAQ-DI), a questionnaire with 20 questions assessing function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The questions are evaluated on a 4-point scale: 0 = without any difficulty; 1 = with some difficulty; 2 = with much difficulty; 3 = unable to do. The 8 category scores are averaged into an overall HAQ-DI score on a scale from 0 (no disability) to 3 (completely disabled). Higher scores indicate greater dysfunction. HAQ response=improvement of at least 0.3 units from baseline.|Baseline, Month 24|All treated participants in the Open-label period. Treatment groups represent treatment received in the Double Blind Period.||participants|||Number
707390|NCT00122382|Secondary|Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses During the Open-Label Period (From Month 12 to Month 24) as Analyzed by ELISA|Serum samples were analyzed by ELISA to detect antibodies against the whole molecule (both CTLA4 and Ig [anti-abatacept antibody]) or solely to CTLA4 (anti-CTLA4-T antibody). Reported as titer, the reciprocal of the sample dilution which yielded a signal equivalent to the statistically set cut point for the assay. For the anti-abatacept assay, minimum required dilution is 400-fold, therefore seronegative samples are those < lowest reportable titer (<400). For the anti-CTLA4-T assay, minimum required dilution is 25-fold, therefore seronegative samples are those < lowest reportable titer (<25).|Includes open-label data up to approximately 85 days post last dose in the open-label period or start of the maintenance sub-study, whichever occurred first.|Treated participants in the open-label period were evaluated for anti-abatacept or anti-CTLA4-T responses||participants|||Number
707391|NCT00122382|Primary|Number of Participants With Serious Adverse Events Reported During the Open-Label Period|SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.|Continuously through open-label period (from Month 12 to Month 24). Includes data up to 56 days post last dose in the open-label period or start of the maintenance sub-study, whichever occurred first.|All subjects who received at least 1 dose of ABA in the open-label period were included in the safety analyses.||participants|||Number
707392|NCT00122382|Primary|Number of Subjects With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs During the Open-Label Period|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Related AE/SAE=Certain, Probable, Possible, or Missing. SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.|Continuously through open-label period (from Month 12 to Month 24). Includes data up to 56 days post last dose in the open-label period or start of the maintenance sub-study, whichever occurred first.|All subjects who received at least 1 dose of ABA in the open-label period were included in the safety analyses.||participants|||Number
707393|NCT00122382|Primary|Mean Change From Baseline in Radiographic Total Score to Month 12|To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions and joint space narrowing (JSN). The total Genant-modified Sharp score ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145). Higher scores indicated more damage.|Baseline, Month 12|The analysis was intent-to-treat. Because the analysis was change from baseline, only those with baseline and post-baseline were included. Linear extrapolation imputation was applied.||units on a scale||Standard Deviation|Mean
707394|NCT00122382|Primary|Number of Participants in DAS 28 C-reactive Protein (CRP) Remission at Month 12|Number of participants who achieved remission at Month 12 of treatment, as defined by a Disease Activity Score (DAS) 28-CRP score of <2.6. DAS 28-CRP is a continuous measure, a composite of 4 variables: number of tender joints out of 28 joints, number of swollen joints out of 28 joints, CRP (in mg/L), and subject assessment of disease activity measure on a Visual Analogue Scale (VAS) of 100 millimeters (mm). The DAS28 scale=0 (best) to 10 (worst), indicating the current activity of the rheumatoid arthritis. A DAS28 >5.1 = high disease activity; <=3.2 = low disease activity; <2.6 = remission.|Month 12|Intent to treat = all randomized and treated subjects. Those with missing data post-discontinuation were considered non-responders.||participants|||Number
707395|NCT00122382|Secondary|Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses in the Double-blind Period as Analyzed by Enzyme-linked-immunosorbent Serologic Assay (ELISA)|Serum samples were analyzed by ELISA to detect antibodies against the whole molecule (both CTLA4 and Ig [anti-abatacept antibody]) or solely to CTLA4 (anti-CTLA4-T antibody). Reported as titer, the reciprocal of the sample dilution which yielded a signal equivalent to the statistically set cut point for the assay. For the anti-abatacept assay, minimum required dilution is 400-fold, therefore seronegative samples are those < lowest reportable titer (<400). For the anti-CTLA4-T assay, minimum required dilution is 25-fold, therefore seronegative samples are those < lowest reportable titer (<25).|includes data up to approximately 85 days past the last dose of the double-blind period or start of the open-label period, whichever occurred first.|Treated participants in the double-blind period who were evaluated for anti-abatacept or anti-CTLA4-T responses||Participants|||Number
707396|NCT00122382|Secondary|Mean Change From Baseline in Radiographic Erosion and Joint Space Narrowing (JSN) Scores to Month 12|To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions and JSN. The erosion score range is 0 (no radiographic damage) to 145 (worst possible radiographic damage). The joint space narrowing score range is 0 (no radiographic damage) to 145 (worst possible radiographic damage). Higher scores indicated more damage. Change from baseline = Post-baseline - Baseline value|Baseline, Month 12|Intention-to-Treat - linear extrapolation imputation. Analysis of change from baseline restricts subjects included in to the analysis to those with baseline and post-baseline.||units on a scale||Standard Deviation|Mean
707397|NCT00122382|Secondary|Adjusted Mean Change in Short Form 36 (SF-36) From Baseline to Month 12|The SF-36 covers 8 health dimensions: 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from 0 to 100, with a higher score indicating better quality of life. Two summary scores (physical and mental component summaries) were produced taking a weighted linear combination of the 8 individual subscales. Change from Baseline=Post-baseline - Baseline value; adjusted for baseline value.|Baseline, Month 12|Last Observation Carried Forward (LOCF) Intent to Treat population = all randomized and treated. As change from baseline analysis, only those with baseline and post-baseline included.||units on a scale||Standard Error|Mean
707398|NCT00122382|Secondary|Number of Participants With Health Assessment Questionnaire (HAQ) Response at Month 12|Physical function was evaluated using the HAQ-disability index (HAQ-DI), a questionnaire with 20 questions assessing function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The questions are evaluated on a 4-point scale: 0 = without any difficulty; 1 = with some difficulty; 2 = with much difficulty; 3 = unable to do. The 8 category scores are averaged into an overall HAQ-DI score on a scale from 0 (no disability) to 3 (completely disabled). Higher scores indicate greater dysfunction. HAQ response=improvement of at least 0.3 units from baseline.|Month 12|Intention-to-Treat=All randomized and treated; all missing data subsequent to discontinuation are considered non-responders.||participants|||Number
707399|NCT00122382|Secondary|Adjusted Mean Change From Baseline in DAS-28-CRP Score to Month 12|DAS 28-CRP is a continuous variable that is a composite of 4 variables: the number of tender joints out of 28 joints, the number of swollen joints out of 28 joints, CRP in milligrams/Liter (mg/L), and subject assessment of disease activity measure on a Visual Analogue Scale (VAS) of 100 millimeters (mm). The DAS28 scale=0 to 10, indicating the current activity of the rheumatoid arthritis. A DAS28 >5.1=high disease activity; <3.2=low disease activity; <2.6=remission. Change from Baseline=Post-baseline - Baseline value; Adjusted for baseline value.|Baseline, Month 12|Last Observation Carried Forward (LOCF) Intent to Treat population = all randomized and treated. As change from baseline analysis, only those with baseline and post-baseline included.||units in a scale||Standard Error|Mean
707400|NCT00122382|Secondary|Number of Participants With Major Clinical Response (MCR) at Month 12|MCR was defined as 6 months of consecutive ACR 70 response at Month 12. ACR 70, the American College of Rheumatology (ACR) definition of 70% improvement was based on a 70% improvement (compared to baseline values) in tender and swollen joint counts and 70% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function, and 1 acute phase reactant value [ie, CRP]).|Month 12|Intention-to-Treat=All randomized and treated; all missing data subsequent to discontinuation are considered non-responders.||participants|||Number
707401|NCT00122382|Secondary|Number of Participants With American College of Rheumatology (ACR) 50 Response at Month 12|ACR 50 response was defined as a 50% improvement from baseline to Month 12 in tender and swollen joint counts and 50% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function), and 1 acute phase reactant value [ie, CRP].|Month 12|Intention-to-Treat=All randomized and treated; all missing data subsequent to discontinuation are considered non-responders.||participants|||Number
707402|NCT00122447|Other Pre-specified|AIM 2: Difference in FMD (Measure of Endothelial Function)|"Comparison of FMD (measure of endothelial function) between NGT, IGT and diabetes at baseline. FMD is a surrogate measure of endothelial function defined as the percent change in dilation of the brachial artery after cuff compression of arm compared to before cuff compression.
No analysis was conducted due to under-recruitment."|Cross-sectional||||||
707403|NCT00122447|Primary|AIM 1: Change in Flow Mediated Dilation (FMD) (%)|Surrogate measure of endothelial function defined as the percent change in dilation of the brachial artery after cuff compression of arm compared to before cuff compression|12 months of intervention|Based on the number of subjects who completed 12 months of intervention and testing||percentage of arterial dilation change||Standard Deviation|Mean
707406|NCT00122460|Secondary|Quality of Life Assessment (EORTC QLQ-C30) Social Functioning|Mean social functioning scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a higher level of social functioning.|at baseline, day 1 of cycle 3, first 6-weekly evaluation following completion of chemotherapy, 6 & 12 months after randomization, reported between day of first patient randomised, 21 Dec 2004,until cut-off date, 12 Mar 2007|Of 361 ITT subjects from countries with EORTC QLQ-C30 available, 291 completed ≥1 evaluable questionnaire. Only time points where ≥ 20% of patients completing a baseline questionnaire remained in the population were analysed. Numbers at each timepoint were (cetuximab +chemotherapy/chemotherapy alone): Baseline:123/109; Cycle3:87/69; Month6:48/23||scores on a scale||Standard Error|Least Squares Mean
707407|NCT00122460|Secondary|Quality of Life (QOL) Assessment European Organisation for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status|Mean global health status scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a better QoL.|at baseline, day 1 of cycle 3, first 6-weekly evaluation following completion of chemotherapy, 6 & 12 months after randomization, reported between day of first patient randomised, 21 Dec 2004,until cut-off date, 12 Mar 2007|Of 361 ITT subjects from countries with EORTC QLQ-C30 available, 291 completed ≥1 evaluable questionnaire. Only time points where ≥ 20% of patients completing a baseline questionnaire remained in the population were analysed. Numbers at each timepoint were (cetuximab+chemotherapy/chemotherapy alone): Baseline: 121/106; Cycle3:87/67; Month6:48/22||scores on a scale||Standard Error|Least Squares Mean
707408|NCT00122460|Secondary|Duration of Response|"Time from first assessment of Complete Response or Partial Response to disease progression or death (within 60 days of last tumor assessment).
Patients without event are censored on the date of last tumor assessment. Tumor assessments based on modified WHO criteria."|time from first assessment of Complete Response or Partial Response to disease progression, death or last tumor assessment, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007|Analysis on ITT population (allocation to treatment groups as randomized). Analysis performed at clinical cut off date, determined by primary endpoint.||months||95% Confidence Interval|Median
707409|NCT00122460|Secondary|Time to Treatment Failure|"Time from randomization to date of the first occurrence of; progression, discontinuation of treatment due to progression or adverse event, start of new anticancer therapy, withdrawal of consent, or death (within 60 days of last tumor assessment).
Patients without event are censored on the date of last tumor assessment."|Time from randomization to treatment failure or last tumor assessment, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007|Analysis on ITT population (allocation to treatment groups as randomized). Analysis performed at clinical cut off date, determined by primary endpoint.||months||95% Confidence Interval|Median
707410|NCT00122460|Secondary|Disease Control|The disease control rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response + Stable Disease as best overall response according to radiological assessments according to investigator (based on modified WHO criteria).|evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007|Analysis on ITT population (allocation to treatment groups as randomized). Analysis performed at clinical cut off date, determined by primary endpoint.||percentage of participants||95% Confidence Interval|Number
707411|NCT00122460|Secondary|Best Overall Response|The best overall response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments according to investigator (based on modified WHO criteria).|evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007|Analysis on ITT population (allocation to treatment groups as randomized). Analysis performed at clinical cut off date, determined by primary endpoint.||percentage of participants||95% Confidence Interval|Number
707412|NCT00122460|Secondary|Progression-free Survival Time (PFS)|"Duration from randomization until radiological progression according to investigator (based on modified World Health Organisation (WHO) criteria) or death due to any cause.
Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment."|time from randomization to disease progression, death or last tumor assessment, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007|Analysis on ITT population (allocation to treatment groups as randomized). Analysis performed at clinical cut off date, determined by primary endpoint.||months||95% Confidence Interval|Median
707413|NCT00122460|Primary|Overall Survival Time (OS)|Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.|time from randomization to death or last day known to be alive, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007|"Primary analysis on Intent to Treat (ITT) population (allocation to treatment groups as randomized).
Analysis performed after the required number of 340 deaths had been reported (expected effect: 36% increase in median survival time, power = 80%, alpha=5% (two-sided)). The Clinical cut-off date was 12 Mar 2007."||months||95% Confidence Interval|Median
707414|NCT00122681|Secondary|Number of Seroconverted Subjects for Anti-HPV-18 Without and With 12-month Persistent Infection|Seroconversion rates for anti-HPV-18 antibodies by ELISA in subjects with breakthrough persistent infections 12-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections. Due to the lack of seronegative subjects at Month 7, the hazard ratio (and Confidence Interval) was not calculated.|At Month 7|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available, only on subjects HPV-18 DNA negative and seronegative at baseline.||Subjects|||Number
707415|NCT00122681|Secondary|Geometric Mean Titers of Anti-HPV-18 in Subjects Without and With 12-month Persistent Infection|GMTs for anti-HPV-18 antibodies by ELISA in subjects with breakthrough persistent infections 12-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections.|At Month 7|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available, only on subjects HPV-18 DNA negative and seronegative at baseline.||EL.U/mL||95% Confidence Interval|Geometric Mean
707416|NCT00122681|Secondary|Number of Seroconverted Subjects for Anti-HPV-18 Without and With 6-month Persistent Infection.|Seroconversion rates for anti-HPV-18 antibodies by ELISA in subjects with breakthrough persistent infections 6-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections. Due to the lack of seronegative subjects at Month 7, the hazard ratio (and Confidence Interval) was not calculated.|At Month 7|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available, only on subjects HPV-18 DNA negative and seronegative at baseline.||Subjects|||Number
707417|NCT00122681|Secondary|Geometric Mean Titers of Anti-HPV-18 in Subjects Without and With 6-month Persistent Infection|GMTs for anti-HPV-18 antibodies by ELISA in subjects with breakthrough persistent infections 6-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections.|At Month 7|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available, only on subjects HPV-18 DNA negative and seronegative at baseline.||EL.U/mL||95% Confidence Interval|Geometric Mean
707418|NCT00122681|Secondary|Number of Seroconverted Subjects for Anti-HPV-16 Without and With 12-month Persistent Infection|Seroconversion rates for anti-HPV-16 antibodies by ELISA in subjects with breakthrough persistent infections 12-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections. Due to the lack of seronegative subjects at Month 7, the hazard ratio (and Confidence Interval) was not calculated.|At Month 7|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available, only on subjects HPV-16 DNA negative and seronegative at baseline.||Subjects|||Number
707419|NCT00122681|Secondary|Geometric Mean Titers of Anti-HPV-16 in Subjects Without and With 12-month Persistent Infection|GMTs for anti-HPV-16 antibodies by ELISA in subjects with breakthrough persistent infections 12-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections.|At Month 7|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available, only on subjects HPV-16 DNA negative and seronegative at baseline.||EL.U/mL||95% Confidence Interval|Geometric Mean
707420|NCT00122681|Secondary|Number of Seroconverted Subjects for Anti-HPV-16 Without and With 6-month Persistent Infection.|Seroconversion rates for anti-HPV-16 antibodies by ELISA in subjects with breakthrough persistent infections 6-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections. Due to the lack of seronegative subjects at Month 7, the hazard ratio (and Confidence interval) was not calculated.|At Month 7|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available, only on subjects HPV-16 DNA negative and seronegative at baseline.||Subjects|||Number
707421|NCT00122681|Secondary|Geometric Mean Titers of Anti-HPV-16 in Subjects Without and With 6-month Persistent Infection|GMT for anti-HPV-16 antibodies by ELISA in subjects with breakthrough persistent infections 6-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections. Due to the lack of seronegative subjects at Month 7, the hazard ratio (and Confidence Interval) was not calculated.|At Month 7|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available, only on subjects HPV-16 DNA negative and seronegative at baseline.||EL.U/mL||95% Confidence Interval|Geometric Mean
707422|NCT00122681|Secondary|Titers for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA)|Titers were expressed as GMTs.|At month 0, 7, 12, 24, 36 and 48|The analyses were performed on the ATP cohort for immunogenicity for whom immunogenicity data were available.||titer||95% Confidence Interval|Geometric Mean
707423|NCT00122681|Secondary|Number of Subjects Seropositive for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA)|"Seropositivity was defined as subjects with a titer equal to or greater than 40.
Subjects with an antibody titer smaller than 40 prior to vaccination were seronegative prior to vaccination and subjects with a titer equal to or greater than 40 were seropositive prior to vaccination."|At Month 0, 7, 12, 24, 36 and 48|The analyses were performed on the ATP cohort for immunogenicity which included subjects for whom immunogenicity data were available.||subjects|||Number
707424|NCT00122681|Secondary|HPV-16 and HPV-18 Geometric Mean Titers (GMT) (V5/J4 Monoclonal Inhibition Test)|Titers were expressed as GMTs in ELISA units per milliliter (EL.U/mL).|Month 0, 7, 12, 24|The analyses was performed on the Total Vaccinated cohort on subjects with available results.||EL.U/mL||95% Confidence Interval|Geometric Mean
707425|NCT00122681|Secondary|HPV-16 and HPV-18 Seroconversion (V5/J4 Monoclonal Inhibition Test)|"HPV-16 V5 cut-off was defined as greater than or equal to 41 ELU/mL. Only seronegative subjects were analysed. Seronegative subjects are subjects who had an antibody titer of less than 41 ELU/mL before vaccination.
HPV-18 J4 cut-off was defined as greater than or equal to 110 EL.U/mL. Both seropositive and seronegative subjects were included in the analysis. Seropositive subjects were subjects with an antibody titer of greater than or equal to 110 EL.U/mL. Seronegative subjects were subjects with an antibody titer less than 110 EL.U/mL."|Month 0, 7, 12 and 24|Analyses was performed on the Total Vaccinated Cohort on subjects with available results.||subjects|||Number
707426|NCT00122681|Secondary|Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset|"Titers are given as Geometric Mean Titers (GMTs) expressed as ELISA Units per milliliter (EL.U/mL).
GMTs are presented for the total group and also stratified according to initial (Month 0) HPV-16 or HPV-18 serostatus by ELISA [seronegative (sero-) or seropositive (sero+)]."|At Months 6, 7, 12, 24, 36 and 48|The analyses were performed on the ATP cohort for immunogenicity for whom immunogenicity data were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
707427|NCT00122681|Secondary|Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus|"Cut-off values assessed for seropositivity include 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.
Results are presented for the total group and stratified according to initial (Month 0) HPV-16 or HPV-18 serostatus by ELISA - seronegative (sero-) or seropositive (sero+)"|At Months 6, 7, 12, 24, 36 & 48|The analyses were performed on the ATP cohort for immunogenicity on evaluable subjects for whom immunogenicity data were available.||subjects|||Number
707516|NCT00123734|Secondary|To Provide Estimates of the Specificity of [99mTc] ThromboView® for Imaging Suspected Distal Initial DVT||May 2007|Number of participants with suspected initial DVT with evaluable images||% Specificity||95% Confidence Interval|Mean
707428|NCT00122681|Secondary|Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN2+ was defined as histopathologically-confirmed lesions including cervical intraepithelial neoplasia of grade 2 (CIN2), grade 3 (CIN3), AIS and invasive cervical cancer.
Oncogenic types detected included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Detection was done in subjects who were HPV DNA negative at baseline, regardless of initial serostatus."|at Month 48|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all evaluable subjects, who had received 3 doses of study vaccine and who had a normal or low-grade cytology (i.e. negative or ASC-US or LSIL) at Month 0.||subjects|||Number
707429|NCT00122681|Secondary|Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN2+ was defined as histopathologically-confirmed lesions including cervical intraepithelial neoplasia of grade 2 (CIN2), grade 3 (CIN3), AIS and invasive cervical cancer.
Oncogenic types detected included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Detection was done in subjects who were HPV DNA negative at baseline, regardless of initial serostatus."|Up to the moment when 36 cases of CIN2+ lesions associated with HPV-16 or HPV-18 infection had been detected, including at least 15 cases of CIN2+ associated with HPV-18 infection. Mean follow-up was 34.9 months post dose 3|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all evaluable subjects, who had received 3 doses of study vaccine and who had a normal or low-grade cytology (i.e. negative or ASC-US or LSIL) at Month 0.||subjects|||Number
707430|NCT00122681|Secondary|Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen|"Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Detection was done in subjects who were HPV DNA negative at baseline regardless of initial serostatus."|at Month 48|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all evaluable subjects, who had received 3 doses of study vaccine and who had a normal or low-grade cytology (i.e. negative or ASC-US or LSIL) at Month 0.||subjects|||Number
707431|NCT00122681|Secondary|Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen|"Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Detection was done in subjects who were HPV DNA negative at baseline regardless of initial serostatus."|Up to the moment when 36 cases of CIN2+ lesions associated with HPV-16 or HPV-18 infection had been detected, including at least 15 cases of CIN2+ associated with HPV-18 infection. Mean follow-up was 34.9 months post dose 3|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all evaluable subjects, who had received 3 doses of study vaccine and who had a normal or low-grade cytology (i.e. negative or ASC-US or LSIL) at Month 0.||Subjects|||Number
707432|NCT00122681|Secondary|Number of Subjects Reporting Persistent Infection (12-month Definition) With HPV-16 or HPV-18|"Persistent cervical HPV infection (12-month definition) was defined as the detection of the same HPV type (by PCR) over a 12-month interval (evaluations were planned at approximately 6-month intervals).
Detection was done in subjects:
DNA- and sero-: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and sero- for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0)
Overall: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline"|at Month 48|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all evaluable subjects, who had received 3 doses of study vaccine and who had a normal or low-grade cytology (i.e. negative or ASC-US or LSIL) at Month 0. All subjects had at least 10 months of follow-up after Month 12.||subjects|||Number
707433|NCT00122681|Secondary|Number of Subjects Reporting Persistent Infection (12-month Definition) With HPV-16 or HPV-18|"Persistent cervical HPV infection (12-month definition) was defined as the detection of the same HPV type (by PCR) over a 12-month interval (evaluations were planned at approximately 6-month intervals).
Detection was done in subjects:
DNA- and sero-: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and sero- for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0)
Overall: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline"|Up to the moment when 36 cases of CIN2+ lesions associated with HPV-16 or HPV-18 infection had been detected, including at least 15 cases of CIN2+ associated with HPV-18 infection. Mean follow-up was 34.9 months post dose 3|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all evaluable subjects, who had received 3 doses of study vaccine and who had a normal or low-grade cytology (i.e. negative or ASC-US or LSIL) at Month 0. All subjects had at least 10 months of follow-up after Month 12||subjects|||Number
707434|NCT00122681|Secondary|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN1+ was defined as histopathologically-confirmed lesions including cervical intraepithelial neoplasia of grade 1 (CIN1), grade 2 (CIN2), grade 3 (CIN3), AIS and invasive cervical cancer.
Detection was done in subjects:
DNA- and sero-: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and sero- for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0)
Overall: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline"|at Month 48|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all evaluable subjects who had a normal or low-grade cytology (i.e. negative or ASC-US or LSIL) at Month 0.||subjects|||Number
707435|NCT00122681|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types|"Oncogenic types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Detection was done in subjects who were HPV DNA negative at baseline regardless of initial serostatus.
HRW-HPV = All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV = High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68"|at Month 48|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all evaluable subjects, who had received 3 doses of study vaccine and who had a normal or low-grade cytology (i.e. negative or ASC-US or LSIL) at Month 0. All subjects had at least 5 months of follow-up after Month 12.||subjects|||Number
707436|NCT00122681|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types|"Oncogenic types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Detection was done in subjects who were HPV DNA negative at baseline regardless of initial serostatus.
HRW-HPV= All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV= High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68"|Up to the moment when 36 cases of CIN2+ lesions associated with HPV-16 or HPV-18 infection had been detected, including at least 15 cases of CIN2+ associated with HPV-18 infection. Mean follow-up was 34.9 months post dose 3|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all evaluable subjects, who had received 3 doses of study vaccine and who had a normal or low-grade cytology (i.e. negative or ASC-US or LSIL) at Month 0. All subjects had at least 5 months of follow-up after Month 12.||subjects|||Number
707437|NCT00122681|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18|"Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval.
Detection was done in subjects:
DNA- and sero-: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and sero- for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0)
Overall: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline."|at Month 48|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all evaluable subjects, who had received 3 doses of study vaccine, who had a normal or low-grade cytology (i.e. negative or ASC-US or LSIL) at Month 0. All subjects had at least 5 months of follow-up after Month 12||subjects|||Number
707438|NCT00122681|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18|"Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval.
Detection was done in subjects:
DNA- and sero-: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and sero- for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0)
Overall: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline"|Up to the moment when 36 cases of CIN2+ lesions associated with HPV-16 or HPV-18 infection had been detected, including at least 15 cases of CIN2+ associated with HPV-18 infection. Mean follow-up was 34.9 months post dose 3|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all evaluable subjects, who had received 3 doses of study vaccine and who had a normal or low-grade cytology (i.e. negative or ASC-US or LSIL) at Month 0. All subjects had at least 5 months of follow-up after Month 12||subjects|||Number
707439|NCT00122681|Secondary|Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus|Pregnancy outcomes are normal infant, premature infant, abnormal infant, elective termination, therapeutic abortion, ectopic pregnancy, spontaneous abortion, still birth, lost to follow-up, no pregnancy/molar pregnancy, pregnancy ongoing.|Throughout the entire study period (Month 0 to Month 48)|Analysis was performed on the Total Vaccinated Cohort and stratified according to initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus.||subjects|||Number
707440|NCT00122681|Secondary|Number of Subjects Reporting Medically Significant Conditions|Medically significant conditions include adverse events (AEs) prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|Throughout entire study period (Month 0 to Month 48)|Analysis was performed on the Total Vaccinated Cohort and stratified according to initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus.||subjects|||Number
707441|NCT00122681|Secondary|Number of Subjects Reporting New Onset of Chronic Disease (NOCDs)|NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.|Throughout the entire study (Month 0 to 48)|Analysis was performed on the Total Vaccinated Cohort and stratified according to initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus.||Subjects|||Number
707442|NCT00122681|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Throughout the entire study period (Month 0 to Month 48)|Analysis was performed on the Total Vaccinated Cohort. The data are presented stratified by initial (Month 0) HPV-16/18 DNA status and according to HPV-16 or 18 serostatus (by ELISA).||subjects|||Number
707443|NCT00122681|Secondary|Number of Subjects Reporting Unsolicited Adverse Events|Unsolicited adverse event (AE) covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within 30 days after any vaccination|Analysis was performed on the Safety Subset of the Total Vaccinated Cohort and stratified according to initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus.||subjects|||Number
707444|NCT00122681|Secondary|Number of Subjects Reporting Solicited Local and General Symptoms|"Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include arthralgia, fatigue, fever (measured in degree celsius (°C) by axillary route), gastrointestinal symptoms, headache, myalgia, rash and urticaria.
Data are presented across the 3 doses."|Within 7 days after any vaccination|Analysis was performed on a safety subset of the Total vaccinated cohort, which included vaccinated subjects from certain sites. Data are presented for the total subset (total), then stratified subject HPV-16/18 DNA & serostatus at baseline: DNA positive (DNA+) or negative (DNA-), ELISA seropositive (sero+) or seronegative (sero-).||subjects|||Number
707466|NCT00123422|Primary|Exercise Endurance|Exercise endurance on a constant workrate treadmill test was measured at 14 weeks. The workload on the constant workrate treadmill test corresponded to the grade and speed that the participate had reached on a symptom-limited treadmill test when they reached 85% of their peak oxygen uptake value.|14 weeks|We used an intent-to treat analysis using the last value carried forward. All participants were included in the final analysis.||minutes||Standard Deviation|Mean
707445|NCT00122681|Secondary|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN1+ was defined as histopathologically-confirmed lesions including cervical intraepithelial neoplasia of grade 1 (CIN1), grade 2 (CIN2), grade 3 (CIN3), AIS and invasive cervical cancer.
Detection was done in subjects:
DNA- and sero-: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and sero- for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0)
Overall: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline"|Up to the moment when 36 cases of CIN2+ lesions associated with HPV-16 or HPV-18 infection had been detected, including at least 15 cases of CIN2+ associated with HPV-18 infection. Mean follow-up was 34.9 months post dose 3|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all evaluable subjects, who had received 3 doses of study vaccine and who had a normal or low-grade cytology (i.e. negative or ASC-US or LSIL) at Month 0.||subjects|||Number
707446|NCT00122681|Primary|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection in Subjects HPV DNA Negative and Seronegative at Baseline or Overall (Any Serostatus at Baseline)|"CIN2+ was defined as CIN grades 2 and 3, endocervical adenocarcinoma in situ (AIS) and invasive cervical cancer.
Detection was done in subjects:
DNA- and sero-: HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative (sero-) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0)
Overall: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline."|at Month 48|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all evaluable subjects who had received 3 doses of study vaccine, who had a normal or low-grade cytology (i.e. negative or Atypical Squamous Cells of Undetermined Significance (ASC-US) or Low-grade Squamous Intraepithelial Lesion (LSIL)) at Month 0.||subjects|||Number
707447|NCT00122681|Primary|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection in Subjects HPV DNA Negative and Seronegative at Baseline or Overall (Any Serostatus at Baseline)|"CIN2+ was defined as CIN grades 2 and 3, endocervical adenocarcinoma in situ (AIS) and invasive cervical cancer.
Detection was done in:
DNA- and sero-: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative (sero-) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0).
Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline."|Up to the moment when 36 cases of CIN2+ lesions associated with HPV-16 or HPV-18 infection had been detected, including at least 15 cases of CIN2+ associated with HPV-18 infection. Mean follow-up was 34.9 months post-dose 3|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all evaluable subjects who had received 3 doses of study vaccine, who had a normal or low-grade cytology (i.e. negative or Atypical Squamous Cells of Undetermined Significance (ASC-US) or Low-grade Squamous Intraepithelial Lesion (LSIL)) at Month 0.||subjects|||Number
707448|NCT00122954|Secondary|Quality of Life (SF-36)|SF-36 is a commonly used measure of health-related quality of life and is well validated in many disease conditions. Responses are self-administered and responses are summed into two subscores, the mental component summary (MCS) and physical component summary (PCS). The SF-36 has eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed on a 0-100 scale. Higher scores represent higher function.|baseline to 3 months|A total of 8 participants discontinued (placebo n = 2, 1 colitis, 1 swallowing problems; treatment n = 8, 2 lost to follow-up, 1 bronchitis, 1 knee surgery, 1 went off anti-depressant, 1 travel difficulties) and did not complete measures at end of study||mean change of units on a scale||Standard Error|Mean
707449|NCT00122954|Primary|Montgomery-Asberg Depression Rating Scale (MADRS)|Higher MADRS scores indicate more severe depression, and the overall score ranges from 0-60. A score of 0-6 indicates symptoms absent, 7-19 indicates mild depression, 20-34 moderate, and > 34 severe. Our primary outcome was 50% or greater improvement on the Montgomery-Asberg Depression Rating Scale (MADRS).|baseline to 3 months|A total of 8 participants discontinued intervention (placebo n = 2, 1 colitis and 1 swallowing problems; treatment n = 6, 2 lost to follow-up, 1 bronchitis, 1 knee surgery, 1 went off antidepressant, 1 travel issues) and did not complete outcome measures||percentage of subjects|||Number
707450|NCT00122980|Secondary|Growth and Development - Weight (Change From Baseline to Endpoint)||baseline to end of study participation (up to 136 weeks)|Intent-to-Treat with endpoint data||kg||Standard Deviation|Mean
707451|NCT00122980|Secondary|Growth and Development - Height (Change From Baseline to Endpoint)||Baseline to end of study participation (up to 136 weeks)|Intent-to-Treat with endpoint data||cm||Standard Deviation|Mean
707452|NCT00122980|Secondary|Woodcock-Johnson Test of Cognitive Abilities (WJ-C) and Achievement (WJ-III) (Change From Baseline)- Verbal Ability|This test is designed to assess both broad and narrow cognitive abilities in children age 4 years and above as well as to measure major aspects of academic achievement in persons aged 2-90 years. Higher scores mean better abilities/achievements. Scaled scores range from 0-100.|Baseline and study exit after up to 30-month treatment period (due to study termination)|Intent-to-Treat. Because the study was terminated, it was not possible to schedule the full battery of neurological assessments on all subjects. Only subjects with both baseline and end of study assessments were included in the analysis.||units on a scale||Standard Deviation|Mean
707453|NCT00122980|Secondary|Woodcock-Johnson Test of Cognitive Abilities (WJ-C) and Achievement (WJ-III) (Change From Baseline)-Excluding Verbal|This test is designed to assess both broad and narrow cognitive abilities in children age 4 years and above as well as to measure major aspects of academic achievement in persons aged 2-90 years. Scaled scores range from 0-100. Higher scores mean better abilities/achievements.|Baseline and study exit after up to 30-month treatment period (due to study termination)|Intent-to-Treat. Because the study was terminated, it was not possible to schedule the full battery of neurological assessments on all subjects. Only subjects with both baseline and end of study assessments were included in the analysis.||units on a scale||Standard Deviation|Mean
707517|NCT00123734|Primary|To Provide Estimates of the Sensitivity of [99mTc] ThromboView® in Patients With Confirmed Initial DVT.||September 2005|||% Sensitivity||95% Confidence Interval|Mean
731774|NCT00399542|Secondary|Month 1 Abdominal Pain Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|28 days|ITT with LOCF||units on a scale||Standard Deviation|Mean
707454|NCT00122980|Secondary|Barthel Index (Change From Baseline)|The Barthel Index is a measure of activities of daily living (ADL) and assesses the degree of disability in a particular participant. The index records indicators of independence in terms of the disability caused by impairments, such as those that may be sequelae of stroke. The index was used as a record of what the participant did, not as a record of what the participant could do. Barthel scores range from 0 to 100, with higher scores indicating greater independence in daily living activities (caring for oneself).|Baseline and study exit after up to 30-month treatment period (due to study termination)|Intent-to-Treat||units on a scale||Standard Deviation|Mean
707455|NCT00122980|Secondary|Pediatric Quality of Life (PedsQL) - Child Report (Change From Baseline)|The PedsQLTM Measurement Model is a modular approach to measuring health-related quality of life (HRQOL) in healthy children and adolescents and those with acute and chronic health conditions. It has a Likert 5-points scale (never to almost always) which were transformed to a 0 to 100 scale based on the PedsQL scoring algorithms, higher scores indicating better quality of life characteristics.|Baseline, midpoint (week 64), and study exit (up to 30 months of treatment)|Intent-to-Treat||units on a scale||Standard Deviation|Mean
707456|NCT00122980|Secondary|Pediatric Quality of Life (PedsQL) - Parent Report (Change From Baseline)|The PedsQL(TM) Measurement Model is a modular approach to measuring health-related quality of life (HRQOL) in healthy children and adolescents and those with acute and chronic health conditions. It has a Likert 5-points scale (never to almost always) which were transformed to a 0 to 100 scale based on the PedsQL scoring algorithms, higher scores indicating better quality of life characteristics.|Baseline, mid-point (week 64), and study exit after up to 30-month treatment period (due to study termination)|Intent-to-Treat||units on a scale||Standard Deviation|Mean
707457|NCT00122980|Primary|Liver Iron Content (LIC) Change-from-baseline|LIC change-from-baseline is the second component of the composite primary endpoint. LIC was measured by quantitative liver biopsy at baseline and at 30 months or exit from the study.LIC values were transformed into Log10 values prior to computing the change from baseline.|Because the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 30 Months)|Intent-to-treat AND both baseline and 30-month post-treatment LICs.||mg ferritin/gram dry weight liver||Standard Deviation|Log Mean
707458|NCT00122980|Primary|Occurrence of an Adjudicated Secondary Stroke During the 30-month Treatment Period|Secondary stroke is the first component of the composite primary endpoint and considers the number of participants with recurrent secondary stroke events during 30 months of treatment. Stroke was defined as any clinical event with brain injury due to vascular disease. All neurological events underwent formal stroke adjudication.|Because the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 30 Months)|The Intent-to-Treat population included all subjects who were randomized and who received any on-study treatment.||participants|||Number
707459|NCT00123123|Secondary|Clinical Pulmonary Infection Score (CPIS) at 48 Hours|"The CPIS score was calculated as follows: 1) Fever: 0 (36.5 to 38.4°C), 1 (38.5 to 39), 2 (<36.0 OR >39.0); 2) Leukocytosis: 0 (4000 to 11,000 white blood cells per mm3 of blood), 1 (11,000 to 17,000), 2 (>17,000); 3) New infiltrate:
0 = None, 1 = Patchy, 2 = Localized; 4) Secretions: 0 = None to minimal, 1 = moderate, 2 = large amount; and 5) PaO2/ FiO2: 0 = more than 330 and 2 = less than 330. Total scores for the subscales can range from 0-10, with lower scores indicating better outcome."|48 hours|||units on a scale||Standard Deviation|Mean
707460|NCT00123123|Primary|Colonization of the Oral Cavity by Respiratory Pathogens (on Teeth/Denture/Buccal Mucosa) as Determined by Quantitative Cultures Expressed as Colony Forming Units (Cfu) Per ml (CFU/mL) of the Aerobic Cultivable Flora After 48 Hours|Samples were diluted and plated on sheep's blood agar (to isolate S. aureus), and MacConkey agar (for isolation of Gram-negative bacilli) and incubated for 72 hours at 37°C in 5% carbon dioxide. Plates were assessed for growth for the following target bacteria: S. aureus, P. aeruginosa, Acinetobacter species, and enteric organisms (Klebsiella pneumoniae, Serratia marcescens, Enterobacter species, Proteus mirabilis, Escherichia coli). Results of quantitative cultures were expressed as colony forming units (cfu) per ml of sample.|Every 48 hours until discharge|All tests were carried out using intent-to-treat analysis, with two-sided tests with a significance level of 0.05. Baseline comparisons between groups were made by analysis of variance (ANOVA) and/or the chi-squared test, as appropriate.||CFU/mL||Standard Deviation|Mean
707461|NCT00123162|Secondary|Improvement in Pain Severity Determined by Visual Analog Scale (VAS).|"The Visual Analog Scale (VAS) assesses pain intensity. The scale is 100 mm long; the extremes of the scale are to the left, no pain and to the right, worst pain I have ever felt. The VAS score is determined by measuring the distance (in mm) from the left side of the scale to the point that the patient marked. The score ranges from 0 to 100, with higher values indicating greater pain."|Each hour of the study (0, 1, 2, 3, 4).|||mm||Standard Deviation|Mean
707462|NCT00123162|Primary|The Primary Outcome Was Total Pain Relief Over 4 Hours (TOPAR4), Comparing a Single Dose of Sildenafil 100 mg to a Single Dose of Placebo.|The Total Pain Relief (TOPAR) Scale rates the level of pain relief on a scale of 0=None, 1=Mild, 2=Moderate, 3=Excellent, 4=Complete. The TOPAR scale was completed each hour after administration of study drug for a total of 4 hours. The 4 hourly scores were summed for a final TOPAR4 score that ranged between 0 and 16, with higher values indicating greater pain relief over time. Missing TOPAR scores after the first hour were imputed using the last-observation-carried-forward approach.|Hours 1, 2, 3 and 4.|||units on a scale||Standard Deviation|Mean
707463|NCT00123409|Secondary|Reduced Problems Related to Alcohol|The Short Inventory of Problmes was used to measure the number of alcohol related problems encountered in the prior 3 months. The scale has a minimum of 0 with lower as better. The max score is 15 with each problem rated as present or absent.|12 months|||# of alcohol problems||Standard Deviation|Mean
707464|NCT00123409|Primary|Reduced Alcohol Use|Alcohol use as measured by the number of drinking days. Lower is better. There are no upper limits. The lower limit is 0.|12 months|||Days drinking||Standard Deviation|Mean
707465|NCT00123422|Secondary|Inspiratory Capacity|Inspiratory capacity measured during exercise is a measure of air-trapping (dynamic hyperinflation). Inspiratory capacity was measured at an isotime (same time) during the constant workrate treadmill test at baseline and 14 weeks.|14 weeks|Intent-to-treat analysis was used so data on all randomized patients were analyzed.||Liters||Standard Deviation|Mean
707518|NCT00123734|Secondary|To Provide Estimates of the Sensitivity of [99mTc] ThromboView® for Imaging Suspected Proximal Initial DVT||May 2007|Number of participants with suspected initial DVT with evaluable images||% Sensitivity||95% Confidence Interval|Mean
707467|NCT00123474|Secondary|Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) That Led toTreatment Discontinuation After 7 Year Follow-up|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Baseline=closest to, but no later than, the first day of study drug for treated participants. After the 2-year analysis and Protocol Amendment 02, those on a BID dosing schedule were allowed to switch to a QD dosing schedule. Due to the large number of participants switching from BID dosing to QD dosing, the abbreviated dosing data collection method incorporated in Amendment 03, the overall safety data are presented for the 100 mg QD group and combined for the other treatment groups.|Baseline to 30 days post last dose, up to 7 years (study closure July 2014)|All randomized participants who received at least one dose of study drug were summarized.||participants|||Number
707468|NCT00123474|Secondary|Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) That Led to Treatment Discontinuation at 24 Months of Follow-up|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Baseline=closest to, but no later than, the first day of study drug for treated participants.|Baseline to 30 days post last dose, up to 24 months|All randomized participants who received at least one dose of study drug were summarized.||participants|||Number
707469|NCT00123474|Secondary|Percent of Participants Overall Survival at 24, 36, 48, 60, 72, and 84 Months Follow-Up - All Randomized Participants|Overall survival (OS) was defined as the time from randomization until death. Survival data were collected for up to 5 years on participants who had discontinued dasatinib treatment. Participants who did not die or who were lost to follow-up were censored on the last date the participant was known to be alive.|24, 36, 48, 60, 72, and 84 months|All participants who were randomized to a treatment arm were summarized.||percentage of participants||95% Confidence Interval|Number
707470|NCT00123474|Secondary|Percent of Participants With Progression Free Survival (PFS) at 24, 36, 48, 60, 72, and 84 Months Follow-Up by Dose Schedule and Total Daily Dose - All Randomized Participants|PFS= time from randomization until: CHR achieved and participant subsequently no longer met criteria for CHR over 2 weeks; no CHR after receiving maximum dose and an increase in WBC (ie, doubling of the count from the lowest value to > 20,000/mm^3 or an increase by > 50,000/mm^3 on 2 assessments performed 2 weeks apart); participant met criteria of accelerated phase or blast phase CML; participant had MCyR and subsequently no longer met criteria for MCyR after starting maximum dose; participant had a ≥ 30% absolute increase in number of Ph+ metaphases. Deaths without a reported prior progression were considered to have progressed on the date of death; those who neither progressed nor died were censored on the date of their last cytogenetic or hematologic assessment. When first progression reported during follow-up, it was censored at last on-study assessment. If the first progression reported during follow-up was death, participant considered to have progressed at date of death.|24, 36, 48, 60, 72, and 84 months|All participants who were randomized to a treatment arm were summarized.||percentage of participants||95% Confidence Interval|Number
707471|NCT00123474|Secondary|Percent of All Randomized Participants With Cytogenic and Hematologic Response by Dosing Schedule (QD or BID) and by Total Daily Dose (100 mg or 140 mg) at 24 Months Follow-Up|Complete cytogenetic response (CCyR): 0% Ph+ cells in metaphase in BM. Partial cytogenetic response (PCyR): >0 to 35% Ph+ cells in metaphase in BM. MCyR: best cytogenetic response of CCyR or PCyR. A complete hematologic response (CHR) was obtained when all the following criteria were met: White Blood Cells (WBC) ≤ institutional upper limit of normal (ULN); Platelets < 450,000/mm³; No blasts or promyelocytes in peripheral blood (PB); < 5% myelocytes plus metamyelocytes in PB; Basophils in PB < 20%; No extramedullary involvement (including no splenomegaly or hepatomegaly). Hematologic responses were counted anytime following 14 days after the dosing start date. No cytogenic assessments were made after 2 years of follow-up.|24 months|All randomized participants were summarized.||percentage of participants||95% Confidence Interval|Number
707472|NCT00123474|Secondary|Percent of All Randomized Participants With Cytogenic and Hematologic Response by Dosing Schedule (QD or BID) and by Total Daily Dose (100 mg or 140 mg) at 6 Months Follow-Up|Complete cytogenetic response (CCyR): 0% Ph+ cells in metaphase in BM. Partial cytogenetic response (PCyR): >0 to 35% Ph+ cells in metaphase in BM. MCyR: best cytogenetic response of CCyR or PCyR. A complete hematologic response (CHR) was obtained when all the following criteria were met: White Blood Cells (WBC) ≤ institutional upper limit of normal (ULN); Platelets < 450,000/mm³; No blasts or promyelocytes in peripheral blood (PB); < 5% myelocytes plus metamyelocytes in PB; Basophils in PB < 20%; No extramedullary involvement (including no splenomegaly or hepatomegaly). Hematologic responses were counted anytime following 14 days after the dosing start date.|6 months|All randomized participants were summarized.||percentage of participants||95% Confidence Interval|Number
707473|NCT00123474|Secondary|Percent of Imatinib Intolerant Participants With Overall Survival After 24, 36, 48, 60, 72, and 84 Months of Follow-up|Overall survival (OS) was defined as the time from randomization until death. Survival data were collected for up to 5 years on participants who had discontinued dasatinib treatment. Participants who did not die or who were lost to follow-up were censored on the last date the participant was known to be alive.|24, 36, 48, 60, 72, and 84 months|All randomized imatinib-intolerant participants were summarized.||percentage of participants||95% Confidence Interval|Number
707482|NCT00123474|Secondary|Time to CHR in Participants With CHR At 24 Months Follow-Up|Time to CHR was defined as the time from the first dosing date until criteria are first met for the response. Non-responders were censored at the maximum time of all participants in their respective group (ie, maximum between time to CHR response for responders and time to last hematologic assessment for non-responders). Cytogenetic assessments were not done after the 2 Year Follow-up.|24 months|Randomized imatinib-resistant participants with CHR were summarized.||Months||95% Confidence Interval|Median
707519|NCT00123734|Secondary|To Provide Estimates of the Specificity of [99mTc] ThromboView® for Imaging Suspected Proximal Initial DVT||May 2007|Number of participants with suspected initial DVT with evaluable images||% Specificity||95% Confidence Interval|Mean
707474|NCT00123474|Secondary|Percent of Imatinib Intolerant Participants With Progression Free Survival After 24, 36, 48, 60, 72, and 84 Months of Follow-Up|PFS= time from randomization until: CHR achieved and participant subsequently no longer met criteria for CHR over 2 weeks; no CHR after receiving maximum dose and an increase in WBC (ie, doubling of the count from the lowest value to > 20,000/mm^3 or an increase by > 50,000/mm^3 on 2 assessments performed 2 weeks apart); participant met criteria of accelerated phase or blast phase CML; participant had MCyR and subsequently no longer met criteria for MCyR after starting maximum dose; participant had a ≥ 30% absolute increase in number of Ph+ metaphases. Deaths without a reported prior progression were considered to have progressed on the date of death; those who neither progressed nor died were censored on the date of their last cytogenetic or hematologic assessment. When first progression reported during follow-up, it was censored at last on-study assessment. If the first progression reported during follow-up was death, participant considered to have progressed at date of death.|24, 36, 48, 60, 72, and 84 months|All randomized imatinib-intolerant participants with available data were summarized||percentage of participants||95% Confidence Interval|Number
707475|NCT00123474|Secondary|Percent of Participants Intolerant to Imatinib With CHR at 6 Months and at 24 Months Follow-Up|A CHR was obtained when all the following criteria were met: White Blood Cells (WBC) ≤ institutional upper limit of normal (ULN); Platelets < 450,000/mm³; No blasts or promyelocytes in peripheral blood (PB); < 5% myelocytes plus metamyelocytes in PB; Basophils in PB < 20%; No extramedullary involvement (including no splenomegaly or hepatomegaly). Hematologic responses were counted anytime following 14 days after the dosing start date.|6 months, 24 months|All randomized imatinib-intolerant participants were summarized.||percentage of participants|||Number
707476|NCT00123474|Secondary|Percent of Participants Intolerant to Imatinib With MCyR at 6 Months and at 24 Months Follow-Up, by QD and BID Schedules and by Total Daily Dose|CyR was based on the number of Ph+ metaphases among cells in metaphase on a BM sample. The criteria for CyR were as follows: complete cytogenetic response (CCyR): 0% Ph+ cells in metaphase in BM; PCyR: >0 to 35% Ph+ cells in metaphase in BM; Minor cytogenetic response: >35 to 65% Ph+ cells in metaphase in BM; Minimal cytogenetic response: >65 to 95% Ph+ cells in metaphase in BM; No cytogenetic response: >95 to 100% Ph+ cells in metaphase in BM; Best CyR was defined as the best response obtained at any time during the study; MCyR was defined as a best CyR of CCyR or PCyR.|6 months, 24 months|All randomized imatinib-intolerant participants with available data were summarized.||percentage of participants||95% Confidence Interval|Number
707477|NCT00123474|Secondary|Percent of Imatinib-Resistant Participants With Overall Survival (OS) at 24, 36, 48, 60, 72, and 84 Months Follow-Up|Overall survival (OS) was defined as the time from randomization until death. Survival data were collected for up to 5 years on participants who had discontinued dasatinib treatment. Participants who did not die or who were lost to follow-up were censored on the last date the participant was known to be alive.|24, 36, 48, 60, 72, and 84 months|All randomized imatinib-resistant participants were summarized.||percentage of participants||95% Confidence Interval|Number
707478|NCT00123474|Secondary|Percent of Imatinib-Resistant Participants With Progression Free Survival (PFS) at 24, 36, 48, 60, 72, and 84 Months Follow-Up|PFS= time from randomization until: CHR achieved and participant subsequently no longer met criteria for CHR over 2 weeks; no CHR after receiving maximum dose and an increase in WBC (ie, doubling of the count from the lowest value to > 20,000/mm^3 or an increase by > 50,000/mm^3 on 2 assessments performed 2 weeks apart); participant met criteria of accelerated phase or blast phase CML; participant had MCyR and subsequently no longer met criteria for MCyR after starting maximum dose; participant had a ≥ 30% absolute increase in number of Ph+ metaphases. Deaths without a reported prior progression were considered to have progressed on the date of death; those who neither progressed nor died were censored on the date of their last cytogenetic or hematologic assessment. When first progression reported during follow-up, it was censored at last on-study assessment. If the first progression reported during follow-up was death, participant considered to have progressed at date of death.|24, 36, 48, 60, 72, and 84 months|All randomized imatinib-resistant participants were summarized.||percentage of participants||95% Confidence Interval|Number
707479|NCT00123474|Secondary|Number of Participants With MCyR and Baseline BCR-ABL Gene Mutation - All Treated Participants|BCR-ABL mutations were assessed in participants prior to the start of study drug (baseline) and at the time of disease progression or at end of therapy. Quantification of BCR-ABL transcripts in peripheral blood was evaluated using quantitative reverse transcriptase polymerase chain reaction (Q-RT-PCR, RT-PCR).|Baseline up to 24 months|All randomized, treated participants with available mutation data were summarized.||participants|||Number
707480|NCT00123474|Secondary|Number of Participants With CHR Whose Disease Progressed by 24 Months|Progression in a participant=achieved a CHR and subsequently no longer met the criteria consistently over a consecutive 2-week period after starting their maximum dose; had no CHR after receiving their maximum dose and had an increase in white blood count (WBC) defined as a doubling of the count from the lowest value to >20,000/mm^3 or an increase by > 50,000/mm^3 on two assessments performed at least 2 weeks apart; met the criteria of accelerated or blast phase CML at any time; had a MCyR and subsequently no longer met the criteria for MCyR after starting their maximum dose; had a ≥ 30% absolute increase in the number of Ph+ metaphases. Although a related secondary endpoint was estimated duration of CHR, medium duration of CHR could not be estimated because the majority of participants with CHR continued to respond, or could not be reliably estimated because of the large number of censored participants.|24 months|All imatinib-resistant participants who achieved CHR and then experienced disease progression were summarized.||participants|||Number
707481|NCT00123474|Secondary|Number of Participants With MCyR Whose Disease Progressed by 24 Months|Progression in a participant=participant achieved a CHR and no longer met the criteria consistently over consecutive 2-weeks after starting their maximum dose; had no CHR after receiving their maximum dose and had an increase in white blood count (WBC) defined as a doubling of the count from the lowest value to >20,000/mm^3 or an increase by > 50,000/mm^3 on two assessments performed at least 2 weeks apart; participant met criteria of accelerated or blast phase CML at any time; had a MCyR and subsequently no longer met the criteria for MCyR after starting their maximum dose; had a ≥ 30% absolute increase in the number of Ph+ metaphases. Although a related secondary endpoint was estimated duration of MCyR, medium duration of MCyR could not be estimated because the majority of participants with MCyR continued to respond, or could not be reliably estimated because of the large number of censored participants. Cytogenetic assessments were not done after the 24 month follow-up.|24 months|All imatinib-resistant participants who had achieved MCyR and experienced disease progression were summarized.||participants|||Number
707483|NCT00123474|Secondary|Time to MCyR in Participants With MCyR at 24 Months Follow-Up|Time to MCyR was defined as the time from the first dosing date until criteria were first met for CCyR or PCyR, whichever occurred first. Non-responders were censored at the maximum time of all participants in their respective group (ie, maximum between time to MCyR response for responders and time to last cytogenetic assessment for non-responders). Cytogenetic assessments were not done after the 2 Year Follow-up.|24 months|Randomized imatinib-resistant participants with MCyR were summarized.||Months||95% Confidence Interval|Median
707484|NCT00123474|Secondary|Time to CHR in Participants With CHR at 6 Months Follow-Up|Time to CHR was defined as the time from the first dosing date until criteria are first met for the response. Non-responders were censored at the maximum time of all participants in their respective group (ie, maximum between time to CHR response for responders and time to last hematologic assessment for non-responders).|6 months|Randomized imatinib-resistant participants with CHR and available data were summarized.||Months||95% Confidence Interval|Median
707485|NCT00123474|Secondary|Time to MCyR in Participants With MCyR at 6 Months Follow-Up|Time to MCyR was defined as the time from the first dosing date until criteria were first met for CCyR or PCyR, whichever occurred first. Non-responders were censored at the maximum time of all participants in their respective group (ie, maximum between time to MCyR response for responders and time to last cytogenetic assessment for non-responders).|6 months|Randomized imatinib-resistant participants with MCyR and available data were summarized.||Months||95% Confidence Interval|Median
707486|NCT00123474|Secondary|Percent of Participants With Complete Hematologic Response (CHR) at 6 and 24 Months Follow-Up|A complete hematologic response (CHR) was obtained when all the following criteria were met: White Blood Cells (WBC) ≤ institutional upper limit of normal (ULN); Platelets < 450,000/mm³; No blasts or promyelocytes in peripheral blood (PB); < 5% myelocytes plus metamyelocytes in PB; Basophils in PB < 20%; No extramedullary involvement (including no splenomegaly or hepatomegaly). Hematologic responses were counted anytime following 14 days after the dosing start date.|6 months, 24 months|All randomized imatinib-resistant participants with available data were summarized.||percentage of participants||95% Confidence Interval|Number
707487|NCT00123474|Secondary|Percent of Participants With MCyR At or Prior to 24 Months Follow-Up|CyR was based on the number of Ph+ metaphases among cells in metaphase on a Bone Marrow (BM) sample. The criteria for CyR were as follows: CCyR: 0% Ph+ cells in metaphase in BM; PCyR: >0 to 35% Ph+ cells in metaphase in BM; Minor cytogenetic response: >35 to 65% Ph+ cells in metaphase in BM; Minimal cytogenetic response: >65 to 95% Ph+ cells in metaphase in BM; No cytogenetic response: >95 to 100% Ph+ cells in metaphase in BM; Best CyR was defined as the best response obtained at any time during the study; MCyR was defined as a best CyR of CCyR or PCyR. Baseline=closest to, but no later than, the first day of study drug for treated participants and closest to, but no later than, the date of randomization, for those who were randomized but who never received treatment, unless otherwise specified.|24 months|All randomized imatinib-resistant participants with available data were summarized.||percentage of Participants||95% Confidence Interval|Number
707488|NCT00123474|Primary|Percent of Participants With Major Cytogenetic Response (MCyR) at 6 Months Follow-Up|Cytogenetic response (CyR) was based on the number of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase on a Bone Marrow (BM) sample. The criteria for CyR were as follows: Complete cytogenetic response (CCyR): 0% Ph+ cells in metaphase in BM; Partial cytogenetic response (PCyR): >0 to 35% Ph+ cells in metaphase in BM; Minor cytogenetic response: >35 to 65% Ph+ cells in metaphase in BM; Minimal cytogenetic response: >65 to 95% Ph+ cells in metaphase in BM; No cytogenetic response: >95 to 100% Ph+ cells in metaphase in BM; Best CyR was defined as the best response obtained at any time during the study; MCyR was defined as a best CyR of complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). Baseline=closest to, but no later than, the first day of study drug for treated participants and closest to, but no later than, the date of randomization, for those who were randomized but who never received treatment, unless otherwise specified.|6 months|All randomized imatinib-resistant participants with available data were summarized.||percentage of Participants||95% Confidence Interval|Number
707489|NCT00123487|Secondary|Number of Participants With Maximal QTcF Intervals up to Year 2 in Treated Participants|A12-lead ECG was obtained at baseline (baseline=within 2 weeks prior to randomization) and once between Day 8 and 29. Additional ECGs were done at the Investigator’s discretion. ECGs were read centrally. QT Interval corrected with Fridericia formula was measured in msec.|Baseline up to Year 2|All participants who received at least one dose of study drug and had appropriate ECG data available were analyzed. Participants were analyzed based on the treatment they actually received, not what they were randomized to receive.||participants|||Number
707490|NCT00123487|Secondary|Number of Participants With Changes From Baseline in QT Interval Corrected With Fridericia Formula (QTcF) up to Year 2 in Treated Participants|A12-lead electrocardiogram (ECG) was obtained at baseline (baseline=within 2 weeks prior to randomization) and once between Days 8 and 29. Additional ECGs were done at the Investigator’s discretion. ECGs were read centrally. The QT interval corrected with Fridericia formula is presented with categories of changes from baseline (BL) in milliseconds (msec).|Baseline to Year 2|All participants who received at least one dose of study drug and had appropriate baseline and on-study ECG data available were analyzed. Participants were analyzed based on the treatment they actually received, not what they were randomized to receive.||participants|||Number
707491|NCT00123487|Secondary|Number of Participants With Normal Baseline Versus Worst Grade 3/4 Biochemistry Laboratory Abnormalities up to Year 2 in Treated Participants|Laboratory abnormalities were graded according to the NCI CTC version 3.0. Grade 3 and 4 criteria were defined as follows: Upper limit of normal (ULN). Alanine transaminase (ALT) Grade (Gr) 3: >5.0 to 20.0*ULN; Gr 4: >20.0*ULN. Aspartate aminotransferase (AST) Gr 3: >5.0 to 20.0*ULN; Gr 4: >20.0*ULN. Total bilirubin Gr 3: >3.0 to 10..0*ULN; Gr 4: >10.0.0*ULN. Serum creatinine (H) Gr 3: >3.0 to 6.0*ULN; Gr 4: >6.0*ULN. Calcium (L) Gr3: 6.0-7.0; Gr 4: <6.0 mg/dL; Phosphorus (L): Gr 3: <2.0 – 1.0 mg/dL , Gr 4: <1.0 mg/dL. Non-hematologic laboratory results were not collected beyond Year 2. Baseline values were obtained within 2 weeks prior to randomization.|Baseline to Year 2|All participants who received at least one dose of study drug were analyzed. Participants were analyzed based on the treatment they actually received, not what they were randomized to receive. Participants who did not have a parameter reported at baseline are indicated.||participants|||Number
707508|NCT00123604|Primary|Flow Mediated Dilation|Flow mediated dilation is a measure of endothelial function. It is measured by the percent change in artery diameter (i.e. dilation), pre and post manual artery occlusion.|change from baseline to 5 months|||percentage of change in dilation||Standard Deviation|Mean
707492|NCT00123487|Secondary|Number of Participants With Grade 4 Myelosuppression Determined From Hematology Evaluations|Laboratory abnormalities were graded according to the National Cancer Institute Common Terminology Criteria (NCI CTC) Version 3.0. Grade 4 hematology evaluations used to determine myelosuppression included: WBC: <1.0*10^9/L. ANC: <0.5*10^9/L. Platelet count <25.0 to 10^9/L.|Day 1 up to Year 7|All participants who received at least one dose of study drug and had laboratory evaluations available were analyzed. Participants were analyzed based on the treatment they actually received, not what they were randomized to receive.||participants|||Number
707493|NCT00123487|Secondary|Number of Participants With Normal Baseline Versus Worst Grade 3/4 Hematology Laboratory Abnormalities up to Year 2 in Treated Participants|Laboratory abnormalities were graded according to the National Cancer Institute Common Terminology Criteria (NCI CTC) version 3.0. CTC Grade 3 and 4 criteria are defined as follows: White blood cells (WBC): Grade (Gr) 3:<2.0 to 1.0*10^9/L, Gr 4:<1.0*10^9/L. Absolute neutrophil count (ANC): Gr 3:<1.0 to 0.5*10^9/L, Gr 4:<0.5*10^9/L. Platelet count Gr 3:<50.0 to 25.0*10^9/L, Gr 4:<25.0 to 10^9/L. Hemoglobin Gr 3:<8.0 to 6.5 g/dL, Gr 4:<6.5 g/dL. Baseline was laboratory value obtained within 2 weeks prior to randomization.|Baseline to Year 2|All participants who received at least one dose of study drug were analyzed. Participants were analyzed based on the treatment they actually received, not what they were randomized to receive. Those participants who did not have a parameter reported at baseline are indicated.||participants|||Number
707494|NCT00123487|Secondary|Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation and Drug-related Fluid Retention AEs, up to Year 7 in Treated Participants|With protocol Amendment 6, the duration of the study was extended for 2 additional years (7 years total) for participants who continued to have clinical benefit and no feasible alternate access to dasatinib. However, after Year 5 the requirement to follow participants for survival and to collect other efficacy data was removed from the protocol for the remainder of the study. Only AEs and SAEs were collected up to Year 7. On-study AEs and SAEs were graded by severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. The investigator AE terms were coded and grouped by preferred term and system organ class using the Medical Dictionary for Regulatory Activities (MedDRA), version 16.0.|Day 1 to Year 7|All participants who received at least one dose of study drug were analyzed. Participants were analyzed based on the treatment they actually received, not what they were randomized to receive.||participants|||Number
707495|NCT00123487|Secondary|Progression Free Survival (PFS) and Overall Survival (OS) at 24, 36, 48, and 60 Months - Randomized Population|PFS was defined as time from randomization until any of the following: Progression of disease (per investigator), or death. For those with blast phase CML or Ph+ ALL, disease progression was: loss of OHR; no decrease from on-study baseline percent blasts in PB or BM on all assessments over a 4-week period after starting maximum dose; absolute increase of at least 50% in PB blast count over a 2-week period after starting maximum dose. For those with accelerated phase CML: the list above also included: Development of blast phase CML at any time after initiation of therapy and development of extra-medullary sites other than spleen or liver. Participants who neither progressed nor died were censored on the date of their last cytogenetic or hematologic assessment. OS was defined as time from randomization until date of death. Participants who had not died or were lost to follow-up were censored on the last date they were known to be alive. Median duration was measured in months.|24 months, 36 months, 48 months, 60 months|Participants were analyzed based on the treatment they were randomized to receive. Kaplan-Meir estimates of PFS or OS (95% Confidence Interval) are provided below.||percentage of participants||95% Confidence Interval|Number
707496|NCT00123487|Secondary|Median Overall Survival (OS) - Randomized Population|OS was defined as time from randomization until date of death. Participants who had not died or who were lost to follow-up were censored on the last date on which the participant was known to be alive. Median duration was measured in months.|Randomization up to 5 Years|Participants were analyzed based on the treatment they were randomized to receive.||Months||95% Confidence Interval|Median
707497|NCT00123487|Secondary|Median Progression Free Survival (PFS) - Randomized Population|PFS was defined as: Time from randomization until any of the following: Progression of disease (per investigator), or death. For those with blast phase CML or Ph+ ALL, disease progression was: loss of OHR; no decrease from on-study baseline percent blasts in PB or BM on all assessments over a 4-week period after starting maximum dose; absolute increase of at least 50% in PB blast count over a 2-week period after starting maximum dose. For those with accelerated phase CML: the list above also included: Development of blast phase CML at any time after initiation of therapy and development of extra-medullary sites other than spleen or liver. Participants who neither progressed nor died were censored on the date of their last cytogenetic or hematologic assessment. Median duration was measured in months.|Randomization up to 5 Years|Participants were analyzed based on the treatment they were randomized to receive.||Months||95% Confidence Interval|Median
707498|NCT00123487|Secondary|Number of Participants With Best Cytogenic Response (CyR) - Randomized Population|Cytogenetic assessments were performed only for the first 2 years of study. CyR was based on the number of Ph+ metaphases among cells in metaphase on a BM sample. The criteria for CyR were as follows: Complete cytogenetic response (CCyR): 0% Ph+ cells in metaphase in BM; Partial cytogenetic response (PCyR): 1% to 35% Ph+ cells in metaphase in BM; Minor cytogenetic response: 36% to 65% Ph+ cells in metaphase in BM; Minimal cytogenetic response: 66% to 95% Ph+ cells in metaphase in BM; No cytogenetic response: 96% to 100% Ph+ cells in metaphase in BM.|Randomization up to 6 Months, 2 Years|Participants were analyzed based on the treatment they were randomized to receive.||participants|||Number
707499|NCT00123487|Secondary|Percent of Participants With Major Cytogenetic Response (MCyR) - Randomized Population|Cytogenetic assessments were performed only for the first 2 years of study. CyR was based on the number of Ph+ metaphases among cells in metaphase on a BM sample. The criteria for CyR were as follows: Complete cytogenetic response (CCyR): 0% Ph+ cells in metaphase in BM; Partial cytogenetic response (PCyR): 1% to 35% Ph+ cells in metaphase in BM; Minor cytogenetic response: 36% to 65% Ph+ cells in metaphase in BM; Minimal cytogenetic response: 66% to 95% Ph+ cells in metaphase in BM; No cytogenetic response: 96% to 100% Ph+ cells in metaphase in BM; Major cytogenetic response (MCyR) was defined as CCyR or PCyR. Percentage: number of participants with MCyR and denominator is number of randomized participants.|Randomization up to 6 Months, 2 Years|Participants were analyzed based on the treatment they were randomized to receive.||percentage of participants||95% Confidence Interval|Number
707500|NCT00123487|Secondary|Number of Participants With Best Confirmed Hematologic Response, Major Hematologic Response (MaHR) and Overall Hematologic Response - Randomized Population|Type of hematologic response: CHR defined as: WBC ≤ ULN; ANC ≥ 1,000/mm^3; - platelets ≥ 100,000/mm^3; - no blasts or promyelocytes in PB; BM blasts ≤ 5%; < 5% myelocytes plus metamyelocytes in PB; basophils in PB < 20%; no extra-medullar involvement (including no hepatomegaly or splenomegaly). NEL defined by the same criteria as CHR except that platelets and ANC had to satisfy at least one of the following (note that both lower limits had to be satisfied): platelets ≥ 20,000/mm^3 and <100,000/mm^3; ANC > 500/mm^3 and <1,000/mm^3. Minor Hematologic Response (MiHR): <15% blasts in BM and in PB; < 30% blasts + promyelocytes in BM and PB; < 20% basophils in PB; No extra-medullary disease other than spleen and liver. Major hematologic response (MaHR ) was CHR or NEL. Overall hematologic response was CHR or NEL or MiHR.|Randomization up to 6 months, 2 years|Participants were analyzed based on the treatment they were randomized to receive.||participants|||Number
707501|NCT00123487|Secondary|Percent of Participants With Overall Hematologic Response - Randomized Population|Overall Hematologic Response (OHR) was defined as CHR, NEL or minor hematologic response (MiHR). CHR was defined as: WBC ≤ ULN; ANC ≥ 1,000/mm^3; - platelets ≥ 100,000/mm^3; - no blasts or promyelocytes in PB; BM blasts ≤ 5%; < 5% myelocytes plus metamyelocytes in PB; basophils in PB < 20%; no extra-medullar involvement (including no hepatomegaly or splenomegaly). NEL defined by the same criteria as CHR except that platelets and ANC had to satisfy at least one of the following (note that both lower limits had to be satisfied): platelets ≥ 20,000/mm^3 and < 100,000/mm^3; ANC > 500/mm^3 and <1,000/mm^3. MiHR defined as: < 15% blasts in BM and in PB; < 30% blasts + promyelocytes in BM and PB; < 20% basophils in PB; No extra-medullary disease other than spleen and liver. Percentage: participants with OHR/ randomized participants.|Randomization up to 6 Months, 2 Years|Participants were analyzed based on the treatment they were randomized to receive.||percentage of participants||95% Confidence Interval|Number
707502|NCT00123487|Secondary|Median Duration of a Major Hematologic Response (MaHR) in Those Participants Who Achieved a MaHR During the Study|MaHR was defined by either CHR or no evidence of leukemia NEL. CHR was defined as: WBC ≤ ULN; ANC ≥ 1,000/mm^3; - platelets ≥ 100,000/mm^3; - no blasts or promyelocytes in PB; BM blasts ≤ 5%; < 5% myelocytes plus metamyelocytes in PB; basophils in PB < 20%; no extra-medullar involvement (including no hepatomegaly or splenomegaly). NEL defined by the same criteria as CHR except that platelets and ANC had to satisfy at least one of the following (note that both lower limits had to be satisfied): platelets ≥ 20,000/mm^3 and < 100,000/mm^3; ANC > 500/mm^3 and <1,000/mm^3. Median duration was measured in months.|Day 1 up to 5 years|Participants who achieved a MaHR during the study.||Months||95% Confidence Interval|Median
707503|NCT00123487|Secondary|Median Time to Major Hematologic Response (MaHR) - Randomized Population|A participants' time to MaHR was defined as the time from the first dosing date until criteria are first met for CHR or NEL, whichever occurred first. Non-responders were censored at the maximum of the date of last hematologic or cytogenetic assessment. Median time was measured in months.|Day 1 up to 6 months (time of primary endpoint), 2 years|Participants were analyzed based on the treatment they were randomized to receive.||Months||95% Confidence Interval|Median
707504|NCT00123487|Secondary|Percent of Participants With Major Hematologic Response (MaHR) by Disease Group - Randomized Population|MaHR was defined by either complete hematologic response (CHR) or no evidence of leukemia (NEL). CHR defined as: white blood cells (WBC) ≤ upper limit of normal (ULN); absolute neutrophil count (ANC) ≥ 1,000/mm^3; platelets ≥ 100,000/mm^3; no blasts or promyelocytes in peripheral blood (PB); bone marrow (BM) blasts ≤ 5%; <5% myelocytes plus metamyelocytes in PB; basophils in PB < 20%; no extra-medullar involvement (including no hepatomegaly or splenomegaly). NEL defined by same criteria as CHR except that platelets and ANC had to satisfy at least one parameter of the following (note that both lower limits had to be satisfied): platelets ≥ 20,000/mm^3 and < 100,000/mm^3; ANC > 500/mm^3 and <1,000/mm^3. After Year 2, Amendment 3 allowed participants to switch from the BID to the QD dosing schedule.. Percentage: participants with MaHR/randomized participants.|Randomization up to 2 years|Participants were analyzed based on the treatment they were randomized to receive. n=number of participants in disease group.||percentage of participants||95% Confidence Interval|Number
707505|NCT00123487|Secondary|Percent of Participants With Major Hematological Response (MaHR) With 2 Years of Follow-up From Date of Last Enrollment - Randomized Population|A MaHR was defined as a participant having either CHR or NEL. CHR was defined as: WBC ≤ ULN; ANC ≥ 1,000/mm^3; - platelets ≥ 100,000/mm^3; - no blasts or promyelocytes in PB; BM blasts ≤ 5%; < 5% myelocytes plus metamyelocytes in PB; basophils in PB < 20%; no extra-medullar involvement (including no hepatomegaly or splenomegaly). NEL defined by the same criteria as CHR except that platelets and ANC had to satisfy at least one of the following (both lower limits had to be satisfied): platelets ≥ 20,000/mm^3 and < 100,000/mm^3; ANC > 500/mm^3 and <1,000/mm^3. After Year 2, Amendment 3 allowed participants to switch from the BID to the QD dosing schedule. Percent: number of participants with MaHR /number of participants randomized.|Randomization up to 2 years|Participants were analyzed based on the treatment they were randomized to receive.||percentage of participants||95% Confidence Interval|Number
707506|NCT00123487|Primary|Percent of Participants With Major Hematologic Response (MaHR) With 6 Months of Follow-up From Date of Last Enrollment - Randomized Population|MaHR defined by either complete hematologic response (CHR) or no evidence of leukemia (NEL). CHR defined as: white blood cells (WBC) ≤ upper limit of normal (ULN); absolute neutrophil count (ANC) ≥ 1,000/mm^3; platelets ≥ 100,000/mm^3; no blasts or promyelocytes in peripheral blood (PB); bone marrow (BM) blasts ≤ 5%; <5% myelocytes plus metamyelocytes in PB; basophils in PB < 20%; no extra-medullar involvement (including no hepatomegaly or splenomegaly). NEL defined by same criteria as CHR except that platelets and ANC had to satisfy at least one of the following (note that both lower limits had to be satisfied): platelets ≥ 20,000/mm^3 and < 100,000/mm^3; ANC > 500/mm^3 and <1,000/mm^3. After Year 2, Amendment 3 allowed participants to switch from the BID to the QD dosing schedule. Percentage: number of participants with MaHR/number of randomized participants.|Randomization up to 6 months|Participants were analyzed based on the treatment they were randomized to receive (not what they actually received). 95% exact confidence interval (CI) presented.||percentage of participants||95% Confidence Interval|Number
707507|NCT00116857|Primary|Beck Depression Inventory-II|Beck Depression Inventory-II scores on a scale of 0 to 63, minimum score equals 0 maximum score equals 63. Higher value represents a worse outcome. Baseline scores are compared to scores after treatment.|Measured at Baseline and 10 weeks|||units on a scale||Standard Deviation|Mean
707520|NCT00123734|Secondary|To Provide Estimates of the Specificity of [99mTc] ThromboView® in Patients With Suspected Recurrent DVT in Whom Disease Recurrence Has Been Excluded||May 2007|Number of participants with suspected recurrent DVT with evaluable images||% Specificity||95% Confidence Interval|Mean
707521|NCT00123734|Primary|To Provide Estimates of the Specificity of [99mTc] ThromboView® in Patients With Excluded Initial DVT||May 2007|Number of participants with suspected initial DVT with evaluable images||% Specificity||95% Confidence Interval|Mean
707522|NCT00124449|Secondary|Number of Participants With Positive Responses for Serum Levels of Abatacept-specific Antibodies|Immunogenicity, as measured by the number of positive repsonses for serum levels of abatacept-specific antibodies measured by enzyme-linked immunosorbent assays (ELISA). Postive response for whole molecule assessment was a value of > 400 and for tip assessment was ≥25.|Up to 12 months|||participants|||Number
707523|NCT00124449|Secondary|Overall Safety - Adverse Events (AEs), Serious AEs, and Deaths|AEs were monitored at all scheduled visits of the study drug treatment and observation periods and at the follow-up visits performed 28, 56, and 85 days after the last infusion of study medication for participants who were withdrawn prematurely|Throughout the treatment period (6 months)|All subjects who received at least 1 dose of study medication||Participants|||Number
707524|NCT00124449|Secondary|Number of Subjects With Health Assessment Questionnaire (HAQ) Disability Index Response|This questionnaire includes 20 questions assessing physical function in 8 domains. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty and 3=unable to do. Higher scores indicate greater dysfunction. HAQ response =improvement of at least 0.3 units from baseline.|6 months, 12 months, 24 months|All randomized and treated participants (n=the number of participants with baseline and postbaseline measurements).||Participants|||Number
707525|NCT00124449|Secondary|Number of Participants With a DAS 28 (CRP) Score of ≤3.2 (Low Disease Activity) or <2.6 (in Remission)|The DAS 28 (CRP) is a composite of 4 variables: tender joint count, swollen joint count, CRP, and subject assessment of disease activity measure on a VAS of 100 mm. Scores for disease activity are defined as low (≤ 3.2) and in remission (< 2.6).|6 months, 12 months, 24 months|All randomized and treated participants (n=the number of participants with baseline and postbaseline measurements).||Participants|||Number
707526|NCT00124449|Secondary|DAS 28 C Reactive Protein (CRP) Score - Mean Change From Baseline|The DAS 28 (CRP) is a composite of 4 variables: 28 tender joint count, 28 swollen joint count, CRP, and subject assessment of disease activity measure on a VAS of 100 mm. Change from Baseline=postbaseline score-baseline score; a lower value signifies improvement.|6 months, 12 months, 24 months|All randomized and treated participants (n=the number of participants with baseline and postbaseline measurements).||units on a scale||Standard Error|Mean
707527|NCT00124449|Secondary|Frequency of Human Leukocyte Antigen (HLA) Typing|To assess the pharmacodynamic effect of abatacept on serum levels of autoantibodies, a blood sample was obtained for HLA typing to determine the presence or absence of alleles associated with RA susceptibility and severity (shared epitope alleles HLA-DRB10401 and HLA-DRB10404).|Day 1|All randomized and treated participants||participants|||Number
707528|NCT00124449|Secondary|Number of Participants With Anti-CCP2 Positive and/or Rheumatoid Factor (RF) Positive Over Time|To assess the pharmacodynamic effect of abatacept on serum levels of autoantibodies, number of participants with Anti-CCP2 Positive of Rheumatoid Factor (RF) positive|Day 1, 6 months, 12 months, 24 months|All randomized and treated participants (n=number of participants with measure at timepoint).||Participants|||Number
707529|NCT00124449|Secondary|Change From Baseline in Cytokine Levels and Second Generation Anti-cyclic Citrullinated Peptide (Anti-CCP2) Antibodies at 6 Months, 12 Months, and 24 Months|To assess pharmacodynamic effect of abatacept on serum levels of autoantibodies, mean change from baseline in cytokines (interleukin-6 [IL-6], interleukin-1B [IL-1B], tumor necrosis factor Alpha [TNF-Alpha], Matrix Metalloproteinase 3T [MMP3T], and anti-CCP2), as measured by standard laboratory investigations, were assessed. Change from baseline=postbaseline value at timepoint (6 or 12 or 24 months) minus baseline value; a lower value signifies improvement.|Baseline, 6 Months, 12 months, 24 months|All randomized and treated participants (n=number of participants with baseline and postbaseline measurements).||laboratory values||Standard Error|Mean
707530|NCT00124449|Secondary|Short Form-36 (SF-36) Physical and Mental Component Summary (PCS and MCS) Scores - Mean Change From Baseline|SF-36, a 36-item instrument that covers 8 quality of life domains, which were used to derive the physical and mental component summary scores, which ranged from 0 to 100, with higher scores indicating a better quality of life. Change from baseline=postbaseline - baseline value; a higher value signifies improvement.|6 months, 12 months, 24 months|All randomized and treated participants (n=number of participants with baseline and postbaseline measurements)||units on a scale||Standard Error|Mean
707531|NCT00124449|Secondary|Number of Participants With Persistent Symptomatic Clinical Synovitis|Synovitis, assessed by clinical signs and symptoms|6, 12, and 24 months|All randomized and treated participants (n=number of participants with assessment at baseline and timepoint)||Participants|||Number
707532|NCT00124449|Secondary|Change From Baseline in Total Erosion, Edema, Synovitis Scores at 6 Months, 12 Months, and 24 Months|Mean change from baseline. Degree of synovitis and structural joint damage (erosion, edema) of the carpal and metacarpophalangeal joints, as measured by magnetic resonance imaging (MRI) scores using the European League Against Rheumatism (EULAR)-Outcome Measures in Rheumatology Clinical Trials (OMERACT) assessment. Edema scale=0 (no bone involved) to 3 (67% to 100% of bone involved). Synovitis scale=0 (normal) and 1-3 (mild, moderate, severe. Bone erosion scale=0 (0% of bone involved) to 10 (91% to 100% of bone involved). Change from baseline=postbaseline score at timepoint - baseline score.|Baseline, 6 months, 12 months, 24 months|All randomized and treated participants (n=number of participants with baseline and postbaseline measurements). MRIs were done only in participants at European Union sites.||units on a scale||Standard Error|Mean
707533|NCT00124449|Secondary|Change From Baseline in Radiographic Erosion and Joint Space Narrowing Score at 6 Months, 12 Months, and 24 Months|Mean change from baseline using the Genant-Modified Sharp Score. Erosion score=assessment of 14 sites in each hand and wrist + 6 joints in each foot, using an 8-point scale from 0 (no erosions) to 3.5 (erosions of 100% or articular surfaces). Joint score= assessment of 13 sites in each wrist and hand + 6 sites in each foot using a 9-point scale from 0 (normal) to 4.0 (definite ankylosis). As-observed data. Change from Baseline=postbaseline score at timepoint (6 or 12 or 24 months) minus baseline score; a lower value signifies improvement.|Baseline, 6 months, 12 months, 24 months|n=participants with a score at baseline and at timepoint||units on a scale||Standard Error|Mean
707534|NCT00124449|Secondary|Number of Participants With Undifferentiated Inflammatory Arthritis (UA) Who Develop Another Rheumatic Disease|Clinical diagnosis of other rheumatic diseases at 12 and 24 months. If a participant discontinued due to lack of efficacy, he/she was regarded as meeting endpoint also.|12 months, 24 months|n=Randomized and treated participants who were RA positive and/or were discontinued due to lack of efficacy. (Those who discontinued due to reasons other than lack of efficacy in the 1- or 2-year window were excluded from the analysis).1 participant in Placebo group was excluded due to the presence of RA at baseline.||Participants|||Number
707535|NCT00124449|Secondary|Number of Participants With a Diagnosis of RA by 1987 ARA Criteria and/or Discontinued Due to Lack of Efficacy|ARA criteria is a 7-item tool for classification purposes; a patient is said to have RA (meeting endpoint) if he or she has satisfied at least 4 of the 7 criteria. If a participant discontinued due to lack of efficacy, he/she was regarded as meeting endpoint also.|24 months|Randomized and treated participants were included in analysis if they were RA positive and/or were discontinued due to lack of efficacy. (Those who discontinued due to reasons other than lack of efficacy in 2-year window were excluded from the analysis). 1 subject in the Placebo group is excluded due to presence of RA at baseline.||Participants|||Number
707536|NCT00124449|Primary|Number of Participants With a Diagnosis of Rheumatoid Arthritis (RA) by American Rheumatism Association (ARA) Criteria and/or Discontinued Due to Lack of Efficacy|ARA criteria is a 7-item tool for RA classification purposes; a patient is said to have RA (meeting endpoint) if he or she has satisfied at least 4 of the 7 criteria. If a participant discontinued due to lack of efficacy, he/she was regarded as meeting primary endpoint also.|12 months|Randomized and treated participants were included in analysis if they were RA positive and/or were discontinued due to lack of efficacy. (Those who discontinued due to reasons other than lack of efficacy in 1-year window were excluded from the analysis). 1 participant in Placebo group was excluded due to presence of RA at baseline.||Participants|||Number
707537|NCT00124462|Primary|Change in WOMAC Function Scale (Most Symptomatic Treated Knee)|The WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) is a self-administered health status measure for pain, stiffness, and function in patients with knee or hip OA. It measures Pain (5 questions), Stiffness (2 questions), and Function (17 questions). The WOMAC function score ranges from 0-68, all items are scored on a scale of 0-4 (0 = None, 1 = Slight, 2 = Moderate, 3 = Very, 4 = Extremely) for difficulty of specific functions. Lower overall function scores indicate higher levels of functioning or less difficulty performing a list of 17 specific activities.|Baseline and 12 weeks|||units on a scale change from baseline||Standard Deviation|Mean
707538|NCT00124462|Primary|Mean Change WOMAC Pain Scale (Most Symptomatic Treated Knee)|The WOMAC (Western Ontario and McMaster Osteoarthritis Index) is a widely used self-administered health status measure used in assessing pain, stiffness, and function in patients with OA of the hip or knee. It measures Pain (5 questions), Stiffness (2 questions), and Function (17 questions). The WOMAC pain scale ranges from 0-20. All the items are scored on a scale of 0-4 (0 = None, 1 = Slight, 2 = Moderate, 3 = Very, 4 = Extremely). Lower scores indicate lower levels of pain.|Baseline and 12 weeks|||units on a scale change from baseline||Standard Deviation|Mean
707539|NCT00124579|Secondary|Progression-Free Survival|From date of initial registration to date of progression/relapse of disease or death from any cause, whichever came first, up to 5 years|about 12-18 months|With ninety patients, we will have 82% power to rule out a null hypothesis of a 12-month median survival versus an alternative hypothesis of an 18-month median survival at a significance level of 5%.||Months||95% Confidence Interval|Median
707540|NCT00124579|Primary|Overall Response Rate Complete Remission (CR), Remission (R), and Partial Remission (PR).|"Responses are defined as follows:
Complete Remission: Absence of bone marrow or blood findings of multiple myeloma. This includes disappearance of all evidence of serum and urine M-proteins on immunofixation electrophoresis studies. Normalization of serum concentrations of normal immunoglobulins is not required for CR. There must also be no evidence of increasing anemia. Bone marrow cellularity must be ≥ 20% with plasma cells ≤ 5%.
Remission: A ≥ 75% reduction in the serum M-protein, and if a urine M-protein (Bence-Jones protein) is present, either a ≥ 90% reduction in this protein, or a urine M-protein < 0.2gm/day. Bone marrow plasma cells must be ≤ 5%.
Partial Remission: A ≥ 50% reduction in the serum M-protein, and if present, a ≥ 50% reduction in the urine M-protein (Bence-Jones protein). Bone marrow plasma cells must not be increased from baseline level."|1 year|Ninety patients is sufficient to distinguish between the null hypothesis that the response rate is 45% versus the alternative of a response rate of 60% with 89% power, using a one-sided test based on the binomial distribution with a significance level of 5%.||percentage of participants|||Number
707541|NCT00124579|Secondary|Toxicity|To evaluate the qualitative and quantitative toxicities associated with this regimen.|From date of protocol therapy start to date of protocol therapy end.|All participants receiving at least one dose of induction therapy||Participants|||Number
707542|NCT00124618|Secondary|Tumor Response (Complete and Partial)|A confirmed tumor response is defined to be a Complete Response (CR) or Partial Response (PR) noted as the objective status on 2 consecutive evaluations at least 3 months apart. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response.|Baseline, 1 month and 4 months after completion of treatment and then every 3 months until Progressive Disease (PD) or up to a maximum of 3 years from registration|||participants|||Number
707543|NCT00124618|Secondary|Time to Disease Progression|Time to disease progression is defined as the time from registration to documentation of disease progression. If a patient dies without a documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death.|From Baseline to up to 3 years|||months||95% Confidence Interval|Median
707544|NCT00124618|Secondary|Survival Time|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.|From baseline to up to 3 years|||months||95% Confidence Interval|Median
707571|NCT00124748|Secondary|Estimated Rates of Progression Free Survival (PFS) on Treatment by Major Molecular Response (MMR)|A Landmark Kaplan-Meier analysis was performed for PFS at 42 months by MMR status at 6, 12, and 18 months to investigate their prognostic value.|42 months|Intent-to-treat (ITT) population consisted of all patients who were randomized to the study treatment. Patients without a valid polymerase chain reaction (PCR) assessment or those who had experienced an event before the landmark were excluded from analysis||Percent probability||95% Confidence Interval|Number
707545|NCT00124618|Primary|11-month Survival Rate|Eleven-month survival was chosen as the survival endpoint in this trial because it represents an improvement over the median survival that is observed with radiation alone. 11-month survival will be considered synonymous with “success”, unless specified otherwise. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. All evaluable patients will be followed from the time of protocol enrollment until death or a minimum of 11 months.|From baseline to 11 months.|This study enrolled a total of 58 patients. All patients received study treatment, and one patient was deemed ineligible during an NCCTG audit. This analysis includes all 57 patients. Forty of 57 patients (70%) reached the 11-month survival primary point.||percentage of participants|||Number
707546|NCT00124657|Secondary|Number of Participants Experiencing Grade 3 or 4 Toxicity Events|Adverse events were collected systematically for each of the 44 Phase II participants from the time of enrollment to the completion of therapy (approximately 2 years from start of therapy).|From start of therapy through 2 years.|All 44 Phase II participants were evaluated. Eight of 16 participants with lymphopenia received dexamethasone within 4 weeks of the recorded toxicity. In both participants with headache, there was a documented progressive disease within 3 days of the recorded headache.||Participants|||Number
707547|NCT00124657|Secondary|Plasma and CSF Levels of VEGF, bFGF, and SDF1|This objective was to determine the plasma and CSF levels of the VEGF, bFGF, and SDF1 at diagnosis, and the plasma levels of these factors at regular intervals during therapy, and to analyze the association of these results with tumor response.|at diagnosis and regular intervals during therapy (up to 2 years after start of therapy)|This objective became obsolete over the course of the protocol, and data was not collected.|||||
707548|NCT00124657|Secondary|To Prospectively Investigate the Technical Factors Involved in Planning and Administering Conformal Fractionated RT as Outlined in This Study, and to Correlate RT Dosimetry With Patterns of Failure, Standard and Investigational Imaging and Toxicity||5 Years|This objective became obsolete over the course of the protocol, and data was not collected.|||||
707549|NCT00124657|Secondary|Correlation Between Standard Magnetic Resonance Imaging and Investigational Radiologic Techniques in Assessing Tumor Response to This Treatment|This objective was to prospectively investigate the correlation between standard magnetic resonance imaging (MRI) and investigational radiologic techniques (MR spectroscopy, perfusion/diffusion, PET scan, DEMRI/BLAST) in assessing tumor response to this treatment.|at diagnosis and regular intervals during therapy (up to 2 years after start of therapy)|This objective became obsolete over the course of the protocol, and data was not collected.|||||
707550|NCT00124657|Secondary|Ability of Erlotinib to Inhibit EGFR Signaling|"The objective was to test the ability of erlotinib to inhibit the EGFR signaling in patients with high-grade glioma who required a second surgery.
This outcome was not assessed due to insufficient availability of tumor and control samples for analysis."|5 Years|This outcome was not assessed due to insufficient availability of tumor and control samples for analysis.|||||
707551|NCT00124657|Primary|Progression Free Survival (PFS)|"Progression-free survival (PFS) distributions for the Phase II participants with anaplastic astrocytoma (AA) and glioblastoma multiforme (GBM) were calculated using Kaplan-Meier estimates (n=41). PFS was defined as the interval between treatment start and initial failure, including clinical or radiologic progression or death from any cause.
PFS was not calculated for the other disease types."|1 and 2 years after end of therapy|Per protocol, 41 participants with either anaplastic astrocytoma or glioblastoma multiforme were analyzed for this outcome.||years||Standard Deviation|Mean
707552|NCT00124657|Primary|Maximum Tolerated Dose (MTD) of Erlotinib|MTD was defined as the highest dosage level in which no more than one of six assessable participants experienced dose-limiting toxicities (DLT). The dosage of erlotinib was increased by approximately 30% in each dosage level starting at 80% of the MTD in adults with solid tumors. A traditional 3+3 dose escalation scheme was used to estimate the MTD.|During the first 8 weeks of therapy.|22 participants were analyzed for MTD over 4 dose levels. One of 23 enrolled participants was not evaluable due to early disease progression.||mg/m^2|||Number
707553|NCT00124657|Secondary|Number of Positive Mutations of EGFR and Downstream Pathways|"Statistical analyses of genomic changes, expression profiles and validation studies should be considered in an exploratory and hypothesis-generating context.
Fresh frozen tumor tissue was obtained at the time of tumor resection and diagnosis. DNA was extracted from formalin-fixed, paraffin-embedded tissue. The entire PTEN coding sequence (exons 1-9), exons 1, 9 and 20 of PIK3CA, and exons 17-24 of EGFR were evaluated using exon-specific PCR amplification, and immunohistochemistry was done. Tumor lesions were considered positive if >25% cells were immunoreactive."|Once at tumor resection and diagnosis|Unstained slides were available for immunohistochemistry analysis in 21 of the 23 Phase I participants.||participants|||Number
707554|NCT00124657|Secondary|AUC Time 0-infinite (AUCinf) of Erlotinib and Its Metabolite OSI-420|Although the calculated dose of erlotinib was rounded to the nearest 25 mg, the actual dosage administered to patients was within 12% of the prescribed dosage in all but 1 patient. The latter patient received erlotinib at the lowest dosage level and the actual dosage was 19% higher than the calculated dose.|After first dose of therapy, and Day 8 of therapy|Pharmacokinetic variables were obtained in 17 patients enrolled on the Phase I portion of the study.||mg*h/mL||Full Range|Median
707555|NCT00124657|Secondary|Erlotinib Tmax|Although the calculated dose of erlotinib was rounded to the nearest 25 mg, the actual dosage administered to patients was within 12% of the prescribed dosage in all but 1 patient. The latter patient received erlotinib at the lowest dosage level and the actual dosage was 19% higher than the calculated dose.|After first dose of therapy|Pharmacokinetic variables were obtained in 17 patients enrolled on the Phase I portion of the study.||hours||Full Range|Median
707556|NCT00124657|Secondary|Cmax of Erlotinib and Its Metabolite OSI-420|Although the calculated dose of erlotinib was rounded to the nearest 25 mg, the actual dosage administered to patients was within 12% of the prescribed dosage in all but 1 patient. The latter patient received erlotinib at the lowest dosage level and the actual dosage was 19% higher than the calculated dose.|After first dose of therapy, and Day 8 of therapy|Pharmacokinetic variables were obtained in 17 patients enrolled on the Phase I portion of the study.||mg/mL||Full Range|Median
707572|NCT00124748|Secondary|Imatinib Pharmacokinetic Trough Plasma Concentration (Cmin) at Month 12|Imatinib PK trough plasma concentration (Cmin) was defined as any pre-dose Imatinib plasma concentration|Month 12|Pharmakokinetic (PK) population consisted of number of patients with a pre-dose PK sample at Month 12||mg/mL||Standard Deviation|Mean
707557|NCT00124657|Primary|Number of Participants With Dose-limiting Toxicity (DLT)|DLT was defined as any of the following toxicities attributable to erlotinib therapy: thrombocytopenia grade 3 and 4; neutropenia grade 4; or any grade 3 and 4 non-hematologic toxicity except for grade 3 diarrhea and grade 3 nausea and vomiting lasting ≤48 hours in participants not receiving optimal supportive therapy, grade 3 skin rash, which did not affect normal daily activities, grade 3 fever or nonneutropenic infection, grade 3 seizures, grade 3 weight gain or loss, and grade 3 transaminase elevation that returned to grade 1 or baseline within 7 days. After enrollment of the first 4 participants, grade 3 and 4 electrolyte abnormalities that resolved to ≤grade 2 within 7 days were excluded as DLT. Toxicities were graded according to the Common Terminology Criteria for Adverse Events version 3.0.|During the first 8 weeks of therapy|23 participants were enrolled on Phase I component; 22 were analyzed for DLT over 4 dose levels. 1 treated at dose level 120mg/m^2 was not assessable for DLT due to early tumor progression. 4 were treated before and 19 after the study was amended to exclude grade 3 and 4 electrolyte abnormalities that resolved to ≤ grade 2 within 7 days.||participants|||Number
707558|NCT00124709|Secondary|Patient/Caregiver Quality of Life|Change from Baseline in the total Parents' Index of Quality of Life-Atopic Dermatitis (PIQoL-AD) score in the double-blind phase. PIQoL-AD Score = (sum of valid items/number of valid items) * 28. Scores range from a minimum value of 0 to a maximum value of 28 with a high total overall score indicating poor quality of life.|From Baseline to Visit 5 , 6, 8, 10, 12, and 14|Intent-to-Treat Population: all randomized patients who were dispensed study medication and had at least one post baseline efficacy measurement.||Scores on PIQoL-AD Scale||Standard Deviation|Mean
707559|NCT00124709|Secondary|Atopic Dermatitis (AD) Remission Time|"Longest duration of atopic dermatitis (AD) remission during the 36 month double-blind treatment phase. A remission day was defined as a diary day with a positive response (yes) to the question No or almost no eczema? and a response of no treatment except emollients to the question Medication used."|36 month Double-Blind Phase|Intent-to-Treat population: all randomized patients who were dispensed study medication and had at least one post baseline efficacy measurement.||Days||Standard Deviation|Mean
707560|NCT00124709|Secondary|Corticosteroid and Pimecrolimus Drug Use|"Corticosteroid and pimecrolimus study medication days of exposure during the 36 month double-blind phase.
Note: Although the double-blind phase was designed to be 36 months (3 years) in length, the last double-blind visit for some patients occurred after 36 months."|48 months|Safety population: all randomized patients who were dispensed study medication.||Days of Exposure||Standard Deviation|Mean
707561|NCT00124709|Secondary|Incidence of Allergic Rhinitis, Allergic Conjunctivitis and Food Allergies|"Percentage of Patients who had allergic rhinitis, allergic conjunctivitis and food allergies at the end of the 36 month double blind study.
Note: The results at six years are not reported due to early termination of the study."|6 years (36 month Double-Blind Phase)|Intent to Treat Population defined as all randomized patients who were dispensed study medication and had at least one post-baseline efficacy measurement.||Percentage of Participants|||Number
707562|NCT00124709|Secondary|Long Term Safety in Infants and Young Children|Note: The results of this secondary outcome is not reported due to early termination of the study.|6 years||||||
707563|NCT00124709|Primary|Effect of Early Use of Pimecrolimus Cream 1% in Reducing the Incidence of Asthma at 6 Years of Age|Note: The results for this efficacy variable are not reported due to early termination of the study.|6 years||||||
707564|NCT00124709|Primary|Atopic Dermatitis (AD) Disease Control Over 36 Months|Proportion of disease-free days in Step 2 or less (per Patient) using total number of days in study as the denominator- double-blind phase. Intent to Treat Population: defined as all randomized patients who were dispensed study medication and had at least one post baseline efficacy measurement.|36 months|Intent to Treat Population: all randomized patients who were dispensed study medication and had at least one post baseline efficacy measurement.||Proportion of disease free days||Standard Deviation|Mean
707565|NCT00124735|Secondary|Duration of Recovery of T4/T1 (TOF Fourth Twitch to First Twitch) Ratio 90%|The time it takes for the the T4 to T1 ratio to reach 90%. The T4/T1 ratio is indicative of recovery. At complete recovery, the T4/T1 ratio is 1.0 (100%).|after surgery, from the reappearance of T3 after Zemuron(R) (rocuronium) infusion/last bolus dose of Zemuron(R) (rocuronium)|per-protocol population||minutes||Standard Deviation|Mean
707566|NCT00124735|Secondary|Duration of Recovery of T4/T1 (TOF Fourth Twitch to First Twitch) Ratio 80%|The time it takes for the the T4 to T1 ratio to reach 80%. The T4/T1 ratio is indicative of recovery. At complete recovery, the T4/T1 ratio is 1.0 (100%).|after surgery, from the reappearance of T3 after Zemuron(R) (rocuronium) infusion/last bolus dose of Zemuron(R) (rocuronium)|per-protocol population||minutes||Standard Deviation|Mean
707567|NCT00124735|Secondary|Duration of Recovery of T4/T1 Ratio (TOF Fourth Twitch to First Twitch) 70%|The time it takes for the the T4 to T1 ratio to reach 70%. The T4/T1 ratio is indicative of recovery. At complete recovery, the T4/T1 ratio is 1.0 (100%).|after surgery, from the reappearance of T3 after Zemuron(R) (rocuronium) infusion/last bolus dose of Zemuron(R) (rocuronium)|per-protocol population||minutes||Standard Deviation|Mean
707568|NCT00124735|Primary|Total Dose of Zemuron (Rocuronium) Administered|Total dose from administration of intubating dose to reappearance of T3 (the third twitch of a Train of Four [TOF] stimulation) after the last maintenance bolus dose or discontinuation of Zemuron (rocuronium) infusion (Per protocol [PP] data set)|during surgery|Per protocol population||mg/kg||Standard Deviation|Mean
707569|NCT00124748|Secondary|Number of Participants With the Effect of Imatinib on the Diabetic Participants With Known Concomitant Type II Diabetes||12 months|Due to the small number of diabetic patients enrolled into the study, the analysis was never done.||Participants|||Number
707570|NCT00124748|Secondary|Time to First Complete Molecular Response (CMR)]|Complete Molecular Response is defined as a Bcr-Abl (a fusion of gene of Bcr and ABl genes) ratio ≤0.0032% on the International Scale Bcr = breakpoint cluster gene Abl = abelson proto-oncogene.|48 months overall|This analysis was not done because no major molecular improvement was observed in the 800mg dose compared to 400mg dose. Hence, analysis for complete molecular response was not necessary.||Months||95% Confidence Interval|Median
707573|NCT00124748|Secondary|Mean Actual Dose Intensity Per Day|The mean actual dose intensity per day from start of treatment up to last dose or discontinuation was evaluated up to Month 36. Actual dose intensity (mg/day) = total dose/time on treatment (periods of zero dose are included)|start of treatment to Month 36|Safety analysis population (SAP): consisted of all patients who received at least one dose of study medication.Subjects are summarized according to the safety treatment allocation (the dose they actually received).||mg/day||Standard Deviation|Mean
707574|NCT00124748|Secondary|Kaplan-Meier Estimates of Duration of First Complete Cytogenetic Response (CCyR)|Duration of CCyR was defined as the time between date of CCyR and the earliest of either (1) loss of CCyR OR (2) (Chronic Myeloid Leukemia) CML-related death or progression to (Accelerated Phase/Blast Crisis) AP/BC during study treatment. Estimated rate of duration of first CCyR was analyzed by Kaplan-Meier estimate (percent probability and 95% Confidence interval).|From first complete cytogenetic response to first confirmed loss or censoring|Intent-to-treat (ITT) population consisted of all patients who are randomized into the study.||Percent probability||95% Confidence Interval|Number
707575|NCT00124748|Secondary|Kaplan-Meier Estimates of Duration of First Major Molecular Response Until Confirmed Loss|Duration of MMR (months) = (date of first confirmed loss or censoring - date of MMR + 1 ) / 30.4375. Estimated rate of duration of first MMR was analyzed by Kaplan-Meier estimate (percent probability and 95% Confidence interval).|From First major molecular response to first confirmed loss or censoring|Intent-to-treat (ITT) population consisted of all patients who are randomized into the study.||Percent probability||95% Confidence Interval|Number
707576|NCT00124748|Secondary|Estimated Rate of Overall Survival (OS) in Two Treatment Arms|OS was defined as time between randomization and death due to any cause during study treatment or during follow-up after discontinuation of treatment. Estimated rate of OS was analyzed by Kaplan-Meier estimate (percent probability and 95% Confidence interval).|60 months over all and follow up period|Intent-to-treat (ITT) population consisted of all patients who are randomized into the study.||Percent probability||95% Confidence Interval|Number
707577|NCT00124748|Secondary|Estimated Rate of Progression to Accelerated Phase (AC)/Blast Crisis (BC) in Two Treatment Arms|(Accelerated Phase/Blast Crisis) AP/BC was defined as time between randomization and either (1) (Chronic Myeloid Leukemia) CML-related death (if death was primary reason for discontinuation) or (2) progression to AP or BC (during treatment). Estimated rate of AC/BC was analyzed by Kaplan-Meier estimate (percent probability and 95% Confidence interval).|60 months over all and follow up period|Intent-to-treat (ITT) population consisted of all patients who are randomized into the study.||Percent probability||95% Confidence Interval|Number
707578|NCT00124748|Secondary|Estimated Rate of Progression Free Survival (PFS) in Two Treatment Arms|PFS on study which was defined as time between randomization and either (1) death due to any cause on treatment of during follow-up after discontinuation of treatment or (2) progression to accelerated phase (AP) or blast crisis (BC) on treatment during follow-up after discontinuation of study treatment. Estimated rate of PFS was analyzed by Kaplan-Meier estimate (percent probability and 95% Confidence interval).|60 months over all and follow up period|Intent-to-treat (ITT) population consisted of all patients who are randomized into the study.||Percent probability||95% Confidence Interval|Number
707579|NCT00124748|Secondary|Estimated Rate of Event Free Survival (EFS) in Two Treatment Arms|EFS on treatment was defined as time between randomization and either (1) death due to any cause during study treatment, (2) progression to accelerated phase (AP) or blast crisis (BC) on treatment, (3) loss of complete hematological response (CHR), or (4) loss of major cytogenic response (MCyR) while on treatment. Estimated rate of EFS was analyzed by Kaplan-Meier estimate (percent probability and 95% Confidence interval).|60 months over all|Intent-to-treat (ITT) population consisted of all patients who are randomized into the study.||Percent probability||95% Confidence Interval|Number
707580|NCT00124748|Secondary|Time to First Complete Hematological Response (CHR)]|Complete Hematological Response (CHR) is defined is where all of the following criteria must be present for ≥4 weeks: White Blood Cell (WBC) count <10 x 109/L, Platelet count <450 x 109/L, Basophils <5%, No blasts and promyelocytes in Peripheral Blood (PB), (Myelocytes + metamyelocytes) < 5% in PB and No evidence of extramedullary involvement. Time to CHR (months) = (date of first CHR or censoring - date of randomization + 1) / 30.4375. Time to first CHR was evaluated using the Kaplan-Meier method.|60 months overall|Intent-to-treat (ITT) population consisted of all patients who are randomized into the study.||Months||95% Confidence Interval|Median
707581|NCT00124748|Secondary|Time to First Complete Cytogenetic Response|Cytogenetic response (CyR) is the percentage of Philadelphia positive metaphases (among at least 20 metaphase cells in Bone Marrow) with Complete Cytogenetic Response (CCyR) being 0 percent. Time to CCyR (months) = (date of first CCyR or censoring - date of randomization + 1) / 30.4375. Time to first CCyR was evaluated using the Kaplan-Meier method.|60 months overall|Intent-to-treat (ITT) population consisted of all patients who are randomized into the study.||Months||95% Confidence Interval|Median
707582|NCT00124748|Secondary|Time to First Major Molecular Response|"MMR is defined as Bcr-Abl (A fusion gene of the breakpoint cluster region [Bcr] gene and Abelson proto-oncogene [Abl] genes) transcript ratio ≤0.1% (≥ 3 log reduction of BCR-ABL transcripts from a standardized baseline), as detected by reverse transcriptase polymerase chain reaction [RT-PCR] (performed centrally).
Time to MMR (months) = (date of first MMR or censoring - date of randomization + 1) / 30.4375. Time to first MMR was evaluated using the Kaplan-Meier method"|42 months overall|Intent-to-treat (ITT) population consisted of all patients who were randomized to the study treatment.||Months||95% Confidence Interval|Median
707583|NCT00124748|Secondary|Percentage of Patients With Undetectable Levels of Bcr-Abl (A Fusion Gene of the Breakpoint Cluster Region [Bcr] Gene and Abelson Proto-oncogene [Abl] Genes) Transcripts|"Undetectable levels or Complete molecular response is defined as Bcr-Abl ratio (%) on international scale (IS) <= 0.0032% (≥ 4.5 log reduction of BCR-Abl transcripts from a standardized baseline)."|12 , 24, 36 and 42 months|Intent-to-treat (ITT) population consisted of all patients who were randomized into the study.||Percentage of Partcipants|||Number
707584|NCT00124748|Secondary|Percentage of Participants With Complete Hematological Response (CHR) Rates at 12, 24, 36, and 42 Months|Complete Hematologic Response (CHR) is where all of the following criteria must be present for ≥4 weeks: White Blood Cell (WBC) count <10 x 109/L, Platelet count <450 x 109/L, Basophils <5%, No blasts and promyelocytes in Peripheral Blood (PB), (Myelocytes + metamyelocytes) < 5% in PB and No evidence of extramedullary involvement.|12, 24, 36, and 42 months|Intent-to-treat (ITT) population consisted of all patients who are randomized into the study.||Percentage of participants|||Number
707585|NCT00124748|Secondary|Percentage of Participants With Complete Cytogenetic Response (CCyR) Rate at 12, 24, 36, 42 Months|Cytogenetic response (CyR)is the percentage of Philadelphia chromosome positive metaphases (among at least 20 metaphase cells in bone marrow (BM)) with Complete Cytogenetic Response (CCyR) being 0 percent.|12, 24, 36, 42 months|Intent-to-treat (ITT) population consisted of all patients who are randomized into the study.||Percentage of Participants|||Number
707586|NCT00124748|Secondary|Percentage of Participants With Major Molecular Response (MMR) Rates at 24, 36, and 42 Months|MMR is defined as Bcr-Abl (A fusion gene of the breakpoint cluster region [Bcr] gene and Abelson proto-oncogene [Abl] genes) transcript ratio ≤0.1% (≥ 3 log reduction of BCR-ABL transcripts from a standardized baseline), as detected by reverse transcriptase polymerase chain reaction [RT-PCR] (performed centrally).|24, 36 and 42 months|Intent-to-treat (ITT) population consisted of all patients who are randomized into the study.||Percentage of participants|||Number
707587|NCT00124748|Primary|Percentage of Participants With Major Molecular Response (MMR) Rates at 12 Months|MMR is defined as Bcr-Abl (A fusion gene of the breakpoint cluster region [Bcr] gene and Abelson proto-oncogene [Abl] genes) transcript ratio ≤0.1% (≥ 3 log reduction of BCR-ABL transcripts from a standardized baseline), as detected by reverse transcriptase polymerase chain reaction [RT-PCR] (performed centrally).|12 months|Intent-to-treat (ITT) population consisted of all patients who are randomized into the study.||Percentage of participants|||Number
707588|NCT00124943|Secondary|Percentage of In-Stent Volume Obstruction at 6 Months|In-stent volume obstruction at 6 months was measured by intra-vascular ultrasound (IVUS) and centrally assessed by the IVUS Core Laboratory. Percent in-stent volume obstruction was calculated as neointimal volume / stent volume * 100.|6 months|Treated population for whom data was available.||Percentage of obstruction||Standard Deviation|Mean
707589|NCT00124943|Secondary|Late Lumen Loss|"Late lumen loss represents the extent of neointimal hyperplasia within the stented region (In-stent) or the stented region plus 5 mm on either side of the stent (In-segment) and was measured by quantitative coronary angiography.
Late Loss = Minimum Lumen Diameter (MLD) Post Procedure minus the MLD at Follow-up."|Day 0 (post-procedure baseline) and 6 months.|"Treated population for whom data was available (indicated by n)."||mm||Standard Deviation|Mean
707590|NCT00124943|Primary|Number of Participants With Major Adverse Cardiac Events (MACE) at 6 Months|Major Adverse Cardiac Events (MACE) includes cardiac death, Coronary Artery Bypass Surgery, Myocardial Infarction, Target Vessel Revascularization (TVR) or Target Lesion Revascularization (TLR) and stent/vessel thrombotic occlusion.|From the day of Percutaneous Coronary Intervention to Month 6.|Treated population.||participants|||Number
707591|NCT00124943|Primary|Number of Participants With Major Adverse Cardiac Events (MACE) at 1 Month|Major Adverse Cardiac Events (MACE) includes cardiac death, Coronary Artery Bypass Surgery, Myocardial Infarction, Target Vessel Revascularization (TVR) or Target Lesion Revascularization (TLR) and stent/vessel thrombotic occlusion.|From the day of Percutaneous Coronary Intervention to 1 Month.|Treated population.||participants|||Number
707592|NCT00124943|Secondary|Percentage of Participants With Binary Restenosis|Binary restenosis was assessed by quantitative coronary angiography and defined as >50% diameter stenosis within the stented region (In-stent) or the stented region plus 5 mm on either side of the stent (In-segment) at follow-up. Angiograms were centrally assessed by the Angiographic Core Laboratory.|6 months|Treated Population.||percentage of participants|||Number
707593|NCT00124943|Primary|Number of Participants With Treatment Emergent Adverse Events (AEs)|"An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
An SAE is any event that:
is fatal or life threatening
results in persistent or significant disability or or incapacity;
requires or prolongs existing hospitalization;
is a congenital anomaly/birth defect in the offspring of a patient who received medication;
conditions not included above that may jeopardize the patient or require intervention to prevent one of the outcomes listed above."|Up to 6 months.|Treated population.||participants|||Number
707594|NCT00124943|Primary|Number of Participants With Procedural Complications|"Procedural complications include the following:
Haemodynamic monitoring: changes in heart rate, arterial blood pressure or electrocardiogram changes;
Arrhythmia: premature ventricular complexes, brady or tachyarrhythmia;
Allergic reactions: rash, flushing, pyrexia, urticaria, angio-oedema;
Angiographic complications: coronary artery spasm, dissection, thrombosis, TIMI (Thrombolysis In Myocardial Infarction) flow, no reflow;
Clinical changes: chest pain."|From Day 0 - Day 1 (from study drug administration until 24 hours post-procedure).|Treated population.||participants|||Number
707595|NCT00124943|Primary|Phase I: Number of Participants With Dose-limiting Toxicities|"Toxicities were evaluated based on the U.S. National Cancer Institute (NCI) Common Terminology Criteria (CTC) for Adverse Events version 3.0. Any drug-related toxicities considered CTC Grade 3 or 4 were considered dose limiting.
The maximum tolerated dose was defined as the lesser of 45 mg/m^2 or the dose at which any drug related toxicities were observed."|Up to 1 week following percutaneous coronary intervention.|Phase I treated population.||participants|||Number
707596|NCT00124982|Secondary|LT; Number of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Responses by ELISA|Serum samples from all treated adult participants with active rheumatoid arthritis (RA) were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.|Days 1-813|Treated participants with available serum samples for assay||participants|||Number
707597|NCT00124982|Secondary|Long-term Period: Mean Time-matched Change From Baseline (Day 0) in SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term|SF-36 has 36 questions with 8 subscale scores and 2 summary scores (1)physical component summary=physical functioning,role-physical,bodily pain,and general health; (2)mental component summary=vitality,social functioning,role-emotional,and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0=worst score and 100=best score. Time-matched mean change from BL= Post-BL value - time-matched BL value. Time-matched BL value=mean BL (Day 0)value for only that cohort with data available at that post-baseline visit.|BL (Day 0), Days 365, 729|All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time||units on a scale||Standard Error|Mean
707625|NCT00124982|Primary|Long-term Period: Change From Baseline in White Blood Cells Over Time|Leukocytes NR=4.1 - 12.3*10^3 c/uL, MA is <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL/>ULN, or if BL>ULN then use >1.2 * BL/<LLN. Neutrophils+bands MA is <1.0 * 10^3 c/uL. Eosinophils MA is >0.750 * 10^3 c/uL. Basophils MA is > 400 mm^3. Monocytes MA is >2000 mm^3. Lymphocytes MA is <0.750 * 10^3 c/uL/ >7.50 * 10^3 c/uL|BL, Day 365, Day 729|All treated participants in the OL. n=number of participants with evaluable laboratory results.||10^3 c/uL||Standard Deviation|Mean
707598|NCT00124982|Secondary|Long-term Period: Mean SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Post-baseline Visits Over the Long Term|SF-36 measures health-related quality of life and has 36 questions with 8 subscale scores and 2 summary scores (1)physical component summary=physical functioning,role-physical,bodily pain,and general health; (2)mental component summary=vitality,social functioning,role-emotional,and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0=worst score and 100=best score. Post-BL values presented for each post-BL visit represent only that cohort of participants with measurements available at that post-BL visit.|Days 365 and 729|All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean post-baseline values reflect changing n-values over time||units on a scale||Standard Deviation|Mean
707599|NCT00124982|Secondary|Long-term Period: Mean Time-matched Baseline (Day 0) SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term|SF-36 has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health;(2) mental component summary=vitality,social functioning,role-emotional, and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score and 100=best score. Time-matched BL (Day 0) values presented for each post-BL visit represent only that cohort of participants with measurements available at that post-BL visit|BL (Day 0)|All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time||units on a scale||Standard Deviation|Mean
707600|NCT00124982|Secondary|Long-term Period: Number of Participants Achieving Clinically Meaningful HAQ Response Over Time|HAQ-DI includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. HAQ-DI= sum of worst scores in each domain divided by the number of domains answered. HAQ-DI ranges from a minimum of 0 (no difficulty) to a maximum overall score of 3(unable to do). Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ disability Index.|BL, Days 365, 449, 533, 617, 729, 813|All treated participants. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements.||participants|||Number
707601|NCT00124982|Secondary|Long-term Period: Mean Time-matched Change From Baseline (Day 0) in HAQ-DI and HAQ-DI Components For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term|HAQ-DI includes 20 questions assessing physical functions in 8 domains:dressing,arising,eating,walking,hygiene,reach,grip and common activities.Domain questions evaluated on 4-point scale: 0=without any difficulty,1=with some difficulty,2=with much difficulty,and 3=unable to do. HAQ-DI=sum of worst scores in each domain ÷ number of domains answered. HAQ-DI minimum=0 (no difficulty), max overall score=3(unable to do). Time-matched mean change from BL= Post-BL value - time-matched BL value. Time-matched BL value=mean BL (Day 0)value for only that cohort with data available at that post-BL visit.|BL (Day 0), Days 365, 449, 533, 617, 729, 813|All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time||units on a scale||Standard Error|Mean
707602|NCT00124982|Secondary|Long-term Period: Mean HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Post-baseline Visits Over the Long Term|HAQ-DI includes 20 questions to assess physical functions in 8 domains:dressing, arising, eating, walking, hygiene, reach, grip and common activities. Domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. HAQ-DI= sum of worst scores in each domain divided by number of domains answered. HAQ-DI minimum=0(no difficulty), max overall score=3(unable to do). Post-BL values presented for each visit represent only that cohort of participants with measurements available at that post-BL visit.|Days 365, 449, 533, 617, 729, 813|All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean post-baseline values reflect changing n-values over time||units on a scale||Standard Deviation|Mean
707603|NCT00124982|Secondary|Long-term Period: Mean Time-matched Baseline (Day 0) HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term|HAQ-DI includes 20 questions to assess physical functions in 8 domains:dressing, arising,eating,walking, hygiene, reach, grip and common activities. Domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. HAQ-DI= sum of worst scores in each domain divided by number of domains answered. HAQ-DI minimum=0 (no difficulty), max overall score=3(unable to do). Time-matched BL(Day 0)values presented for each post-BL visit represent only that cohort of participants with measurements available at that post-BL visit.|BL (Day 0)|All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time||units on a scale||Standard Deviation|Mean
707604|NCT00124982|Secondary|Long-term Period: Mean Time-matched Change From Baseline (Day 0) in VAS Over the Long Term|The VAS for Fatigue (VAS-F) consists of a 100 mm line, with 0 (No Fatigue) on 1 end and 100 (Extreme Fatigue) on the other end, which a participant marks to indicate how much fatigue he or she feels. The marked point in mm is converted into a numeric value from 0 to 100, where 0=no fatigue and 100=maximum fatigue. Increasing numbers=increasing fatigue. Time-matched mean change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL (Day 0) value for only that cohort of participants with data available at that post-BL visit.|BL (Day 0), Days 365, 449, 533, 617, 729, 813|All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time||units on a scale||Standard Error|Mean
707626|NCT00124982|Primary|Long-term Period: Change From Baseline in Platelets (PLT) Over Time|Erythrocytes NR= 3.80 - 5.50 *10^6 c/uL, MA is <0.75 * BL|BL, Day 365, Day 729|All treated participants in the OL. n=number of participants with evaluable laboratory results.||10^9 c/L||Standard Deviation|Mean
707605|NCT00124982|Secondary|Long-term Period: Mean Time-matched Baseline (Day 0) Visual Analog Scale (VAS) and VAS for Post-Baseline Visits Over the Long Term|The VAS for Fatigue (VAS-F) consists of a 100 mm line, with 0 (No Fatigue) on 1 end and 100 (Extreme Fatigue) on the other end, which a participant marks to indicate how much fatigue he or she feels. The marked point in mm is converted into a numeric value from 0 to 100, where 0=no fatigue and 100=maximum fatigue. Increasing numbers=increasing fatigue. Time-matched baseline (Day 0) values and post-baseline values were presented for each post-baseline visit, and represent only that cohort of participants with measurements available at that post-baseline visit.|BL (Day 0), Days 365, 449, 533, 617, 729, 813|All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time||units on a scale||Standard Deviation|Mean
707606|NCT00124982|Secondary|Long-term Period: Mean Time-matched Change From Baseline (Day 0) in Hs-CRP Level Over the Long Term|hs-CRP is a acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA). Levels of hs-CRP can be used to determine DAS28. Time-matched mean change from baseline = Post-baseline value - time-matched baseline value, where the time-matched baseline value represents the mean baseline (Day 0) value for only that cohort of participants with measurements available at that post-baseline visit.|BL (Day 0), Days 365, 449, 533, 617, 729, 813|All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time||mg/dL||Standard Error|Mean
707607|NCT00124982|Secondary|Long-term Period: Mean Time-matched Baseline (Day 0) Hs-CRP Levels and Hs-CRP Levels for Post-Baseline Over the Long Term|hs-CRP is a acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA). Levels of hs-CRP can be used to determine DAS28. Time-matched baseline (Day 0) values and post-baseline values were presented for each post-baseline visit, and represent only that cohort of participants with measurements available at that post-baseline visit.|BL (Day 0), Days 365, 449, 533, 617, 729, 813|All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time||mg/dL||Standard Deviation|Mean
707608|NCT00124982|Secondary|Long-term Period: Mean Time-Matched Change From Baseline (Day 0) in Number of Swollen Joints Over the Long Term|The mean number of swollen joints was evaluated based on the number of swollen joints in a standard 66 joint count. Time-matched mean change from baseline = Post-baseline value - time-matched baseline value, where the time-matched baseline value represents the mean baseline (Day 0) value for only that cohort of participants with measurements available at that post-baseline visit.|BL (Day 0), Days 365, 449, 533, 617, 729, 813|All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time||swollen joints||Standard Error|Mean
707609|NCT00124982|Secondary|Long-term Period: Mean Time-matched Baseline (Day 0) Number of Swollen Joints And Post-Baseline Number of Swollen Joints Over the Long Term|The mean number of swollen joints was evaluated based on the number of swollen joints in a standard 66 joint count. Time-matched baseline (Day 0) values and post-baseline values were presented for each post-baseline visit, and represent only that cohort of participants with measurements available at that post-baseline visit.|BL (Day 0), Days 365, 449, 533, 617, 729, 813|All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time||swollen joints||Standard Deviation|Mean
707610|NCT00124982|Secondary|Long-term Period: Mean Time-matched Change From Baseline (Day 0) in Number of Tender Joints Over the Long Term|The mean number of tender joints was evaluated based on the number of tender joints in a standard 68 joint count. Time-matched mean change from baseline = Post-baseline value - time-matched baseline value, where the time-matched baseline value represents the mean baseline (Day 0) value for only that cohort of participants with measurements available at that post-baseline visit.|BL (Day 0), Days 365, 449, 533, 617, 729, 813|All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time||tender joints||Standard Error|Mean
707611|NCT00124982|Secondary|Long-term Period: Mean Time-matched Baseline (Day 0) Number of Tender Joints and Number of Tender Joints for Post-Baseline Visits Over the Long Term|The mean number of tender joints was evaluated based on the number of tender joints in a standard 68 joint count. Time-matched baseline (Day 0) values and post-baseline values were presented for each post-baseline visit, and represent only that cohort of participants with measurements available at that post-baseline visit.|BL (Day 0), Days 365, 449, 533, 617, 729, 813|All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time||tender joints||Standard Deviation|Mean
707612|NCT00124982|Secondary|Long-term Period: Mean Time-matched Change From Baseline (Day 0) in DAS 28 Over The Long Term|The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). Time-matched mean change from BL= Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL(Day 0)value for only that cohort of participants with measurements available at that post-BL visit.|BL (Day 0), Days 365, 449, 533, 617, 729, 813|All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time||units on a scale||Standard Error|Mean
707627|NCT00124982|Primary|Long-term Period: Change From Baseline in Erythrocytes Over Time|Erythrocytes NR= 3.80 – 5.50 *10^6 c/uL, MA is <0.75 * BL|BL, Day 365, Day 729|All treated participants in the OL. n=number of participants with evaluable laboratory results.||10^6 c/uL||Standard Deviation|Mean
707922|NCT00128180|Secondary|Duration of ICU Stays||6 months|Per protocol, efficacy analysis was limited to participants with confirmed hantavirus infection, and this analysis was limited to those who were admitted to ICU. Four subjects with confirmed hantavirus infection were not admitted to ICU.||days||Standard Deviation|Mean
707613|NCT00124982|Secondary|Long-term Period: Mean Time-matched Baseline (Day 0) DAS 28 and DAS 28 for Post-Baseline Visits Over the Long Term|The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). Time-matched baseline (Day 0)values and post-baseline values were presented for each post-baseline visit, and represent only that cohort of participants with measurements available at that post-baseline visit.|BL (Day 0), Days 365, 449, 533, 617, 729, 813|All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time||units on a scale||Standard Deviation|Mean
707614|NCT00124982|Secondary|Long-term Period: Number of Participants With Clinically Meaningful Improvement in DAS 28, Low Disease Activity, or Remission Over Time|The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). A clinically significant response= decrease in DAS28 score of >1.2 from baseline.|BL, Days 365, 449, 533, 617, 729, 813|All treated participants. n=number of evaluable participants.||participants|||Number
707615|NCT00124982|Secondary|Short-term Period: Mean Change From Baseline to Day 169 in Fatigue Visual Analog Scale (VAS)|The VAS for Fatigue (VAS-F) consists of a 100 mm line, with 0 (No Fatigue) on 1 end and 100 (Extreme Fatigue) on the other end, which a participant marks to indicate how much fatigue he or she feels. The marked point in mm is converted into a numeric value from 0 to 100, where 0=no fatigue and 100=maximum fatigue. Increasing numbers=increasing fatigue.|BL, Day 169|All treated participants||units on a scale||Standard Deviation|Mean
707616|NCT00124982|Secondary|Short-term Period: Mean Baseline Fatigue Visual Analog Scale (VAS)|The VAS for Fatigue (VAS-F) consists of a 100 mm line, with 0 (No Fatigue) on 1 end and 100 (Extreme Fatigue) on the other end, which a participant marks to indicate how much fatigue he or she feels. The marked point in mm is converted into a numeric value from 0 to 100, where 0=no fatigue and 100=maximum fatigue. Increasing numbers=increasing fatigue.|BL|All treated participants||units on a scale||Standard Deviation|Mean
707617|NCT00124982|Secondary|Short-term Period: Mean Change From Baseline to Day 169 in SF-36 PCS, MCS, and SF-36 Individual Component Scores|The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.|BL, Day 169|All treated participants. n=number of evaluable participants.||units on a scale||Standard Deviation|Mean
707618|NCT00124982|Primary|Long-term Period: Mean Temperature (T) Over Time||From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept|All treated participants. n=number of participants with evaluable temperature readings.||degrees Celsius||Standard Deviation|Mean
707619|NCT00124982|Primary|Long-term Period: Mean Heart Rate (HR) Over Time||From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept|All treated participants. n=number of participants with evaluable heart rate readings.||beats per minute||Standard Deviation|Mean
707620|NCT00124982|Primary|Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time|Measurements were taken in a seated position before and after abatacept infusion.|From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept|All treated participants. n=number of participants with evaluable blood pressure readings.||mm Hg||Standard Deviation|Mean
707621|NCT00124982|Primary|Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time|Measurements were taken in a seated position before and after abatacept infusion.|From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept|All treated participants. n=number of participants with evaluable blood pressure measurements.||mm Hg||Standard Deviation|Mean
707622|NCT00124982|Primary|LT; Change From Baseline in Sodium (Na), Potassium (K), Chloride (Cl) Over Time|Na NR=132 – 147 mEq/L, MA is 95* LLN/ >1.05* ULN, or if BL<LLN then use 0.95* BL or >ULN, or if BL>ULN then use>1.05* BL or <LLN. K NR=3.3 – 5.5 mEq/L, MA is <0.9* LLN/>1.1* ULN,or if BL<LLN then use 0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN. Cl NR=94 – 111 mEq/L, MA is <0.9* LLN/>1.1* ULN, or if BL<LLN then use 0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN|BL, Day 365, Day 729|All treated participants in the OL. n=number of participants with evaluable laboratory results.||mEq/L||Standard Deviation|Mean
707623|NCT00124982|Primary|Long-term Period: Change From Baseline in Bilirubin, Blood Urea Nitrogen (BUN), Creatinine, Calcium (Ca), Phosphorus (P), Serum Glucose (Glu), and Uric Acid Over Time|Bilirubin NR=0.2–1.2 mg/dL, MA: >2* ULN, or if BL>ULN then use >4* BL. BUN NR=4.0–24.0 mg/dL, MA: >2*BL. Creatinine NR=0.4–1.2 mg/dL, MA: >1.5*BL. Ca NR=8.8–10.2 mg/dL, MA: <0.8*LLN/>1.2*ULN, or if BL<LLN then use 0.75*BL or >ULN, or if BL>ULN then use>1.25*BL or <LLN. P NR=2.8–4.0 mg/dL, MA: <0.75*LLN/ >1.25*ULN, or if BL<LLN then use 0.67*BL or >ULN, or if BL>ULN then use>1.33*BL or <LLN. Glu MA: <65 mg/dL/ >220 mg/dL. Uric acid MA: >1.5*ULN, or if BL>ULN then use >2*BL.|BL, Day 365, Day 729|All treated participants in the OL. n=number of participants with evaluable laboratory results.||mg/dL||Standard Deviation|Mean
707624|NCT00124982|Primary|Long-term Period: Change From Baseline in Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), and G-Glutamyl Transferase (GGT) Over Time|HGB normal range (NR)=11.6 - 16.2 g/dL, marked abnormality (MA) is >3 g/dL decrease from BL. Total protein NR=6.0 - 8.4 g/dL, MA is <0.9* LLN/>1.1* ULN; Albumin NR=3.5 - 5.3 g/dL, MA is <0.9* LLN, or if BL<LLN then use <0.75 BL|BL, Day 365, Day 729|All treated participants in the OL. n=number of participants with evaluable laboratory results.||U/L||Standard Deviation|Mean
707773|NCT00126737|Secondary|Walking Distance|Average distance walked in six minutes. The average change in distance walked (meters) 24 weeks post-baseline was measured.|Between Base-line and 24 weeks|There are discrepancies in the numbers of participants being analyzed due to incomplete data collection. the disprepancies are in the following groups: 1 in Weight control Nutritional and home -based Exercise program, 2 in Weight Control Nutritional Program.||Change in Distance (m)||95% Confidence Interval|Mean
707628|NCT00124982|Primary|Long-term Period: Change From Baseline in Hematocrit Over Time|The hematocrit value refers to the percentage of blood volume that is occupied by red blood cells. Hematocrit values for participants were expressed as percentages and were averaged to yield a group mean value (percentage) at a particular time point. The mean change from baseline in hematocrit value (expressed as a percent)= mean post-baseline value (expressed as a percent) - mean baseline value (expressed as a percent).|BL, Day 365, Day 729|All treated participants in the OL. n=number of participants with evaluable laboratory results.||percentage change||Standard Deviation|Mean
707629|NCT00124982|Primary|Long-term Period: Change From Baseline in Hemoglobin (HGB), Total Protein, and Albumin Over Time|HGB normal range (NR)=11.6 – 16.2 g/dL, marked abnormality (MA) is >3 g/dL decrease from BL. Total protein NR=6.0 – 8.4 g/dL, MA is <0.9* LLN/>1.1* ULN; Albumin NR=3.5 – 5.3 g/dL, MA is <0.9* LLN, or if BL<LLN then use <0.75 BL|BL, Day 365, Day 729|All treated participants in the OL. n=number of participants with evaluable laboratory results.||g/dL||Standard Deviation|Mean
707630|NCT00124982|Primary|Long-term Period: Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria|Marked abnormality criteria: serum glucose (Glu):<65 mg/dL/ >220 mg/dL; fasting serum Glu: <0.8* LLN/>1.5* ULN, or if BL<LLN then use 0.8* BL or >ULN, or if BL>ULN then use >2.0* BL or <LLN; total protein: <0.9* LLN/>1.1* ULN; albumin: <0.9* LLN,or if BL<LLN then use <0.75 BL; uric acid: >1.5* ULN, or if BL>ULN then use >2* BL. Urinalysis (Urine protein, urine Glu, urine blood, leukocyte esterase, Red Blood Cells [RBCs], White Blood Cells [WBCs]):Use ≥2 when BL value missing or value ≥4,or when pre-dose=0 or 0.5. Use ≥3 when pre-dose=1. Use ≥4 when pre-dose=2 or 3|From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept|All treated participants. n=number of participants with evaluable laboratory results.||participants|||Number
707631|NCT00124982|Primary|Long-term Period: Number of Participants With Electrolyte Laboratories Meeting MA Criteria|Marked abnormality criteria:Sodium (Na): <0.95* LLN/ >1.05* ULN,or if BL<LLN then use 0.95* BL or >ULN,or if BL>ULN then use>1.05* BL or <LLN; potassium (K): <0.9* LLN/>1.1* ULN,or if BL<LLN then use 0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; chloride: <0.9* LLN/>1.1* ULN, or if BL<LLN then use 0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; calcium (Ca): <0.8* LLN/>1.2* ULN, or if BL<LLN then use 0.75* BL or >ULN, or if BL>ULN then use>1.25* BL or <LLN; phosphorous (P): <0.75* LLN/ >1.25* ULN, or if BL<LLN then use 0.67* BL or >ULN, or if BL>ULN then use>1.33* BL or <LLN|From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept|All treated participants. n=number of participants with evaluable laboratory results.||participants|||Number
707632|NCT00124982|Primary|Long-term Period: Number of Participants With Liver and Kidney Function Laboratories Meeting MA Criteria|Marked abnormality criteria: Alkaline phosphatase (ALP): >2*ULN, or if BL>ULN, use >3*BL; aspartate aminotransferase (AST): >3*ULN, or if BL>ULN,use >4*BL; alanine aminotransferase (ALT): >3*ULN, or if BL>ULN, use >4*BL; G-Glutamyl transferase (GGT): >2*ULN, or if BL>ULN, use >3*BL; bilirubin: >2*ULN, or if BL>ULN, use >4*BL; blood urea nitrogen (BUN): >2*BL; creatinine: >1.5*BL|From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept|All treated participants. n=number of participants with evaluable laboratory results.||participants|||Number
707633|NCT00124982|Primary|Long-term Period: Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria|ULN=upper limit of normal; LLN=lower limit of normal; BL=baseline. Marked abnormality criteria=Hemoglobin: >3 g/dL decrease from BL; Hematocrit: <0.75*BL; Erythrocytes:<0.75*BL; Platelets: <0.67*LLN/>1.5 * ULN, or if BL<LLN, use 0.5*BL/<100,000 mm^3; Leukocytes: <0.75*LLN/>1.25*ULN, or if BL<LLN, use <0.8*BL/>ULN, or if BL>ULN,use >1.2*BL/<LLN; neutrophils+bands: <1.0*10^3 c/uL; eosinophils: >0.750*10^3 c/uL; basophils: >400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750*10^3 c/uL/>7.50*10^3 c/uL.|From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept|Participants who received at least 1 infusion of abatacept during the long-term treatment period. n=number of participants with evaluable laboratory results.||participants|||Number
707634|NCT00124982|Primary|Long-term Period: Number of Participants With AEs of Special Interest|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).|From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept|All treated participants||participants|||Number
707635|NCT00124982|Primary|Long-term Period: Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuations, AEs, Related AEs, or AEs Leading to Discontinuations|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with treatment.SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.Related AE/SAE=Certain,Probable,Possible,or Missing relationship to Drug|From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept|All treated participants||participants|||Number
707636|NCT00124982|Secondary|Short-term Period: Mean Baseline Short Form 36 (SF-36) Quality of Life Physical Component Summary (PCS), Mental Component Summary (MCS), and SF-36 Individual Component Scores|The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.|BL|All treated participants. n=number of evaluable participants.||units on a scale||Standard Deviation|Mean
707923|NCT00128180|Secondary|Number of Participants on Extracorporeal Membrane Oxygenation (ECMO)|number of participants|6 months|Per protocol, efficacy analysis was limited to participants with confirmed hantavirus infection.||participants|||Number
707637|NCT00124982|Secondary|Short-term Period: Number of Participants Achieving a Clinically Meaningful HAQ Response|HAQ-DI includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. HAQ-DI= sum of worst scores in each domain divided by the number of domains answered. HAQ-DI ranges from a minimum of 0 (no difficulty) to a maximum overall score of 3(unable to do). Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ disability Index.|BL, Day 169|All treated participants||participants|||Number
707638|NCT00124982|Secondary|Short-term Period: Mean Change From Baseline to Day 169 in the Health Assessment Questionnaire Disability Index (HAQ-DI)|The HAQ-DI includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. HAQ-DI= sum of worst scores in each domain divided by the number of domains answered. HAQ-DI ranges from a minimum of 0 (no difficulty) to a maximum overall score of 3(unable to do).|BL, Day 169|All treated participants||units on a scale||Standard Deviation|Mean
707639|NCT00124982|Secondary|Short-term Period: Mean Change From Baseline to Day 169 in Rheumatoid Factor (RF)|RF is an autoantibody (antibody directed against an organism's own tissues) most relevant in rheumatoid arthritis. It is an antibody against the Fc portion of Immunoglobulin (Ig)G, which is itself an antibody. RF and IgG join to form immune complexes which contribute to the disease process.|BL, Day 169|All treated participants||IU/mL||Standard Deviation|Mean
707640|NCT00124982|Secondary|Short-term Period: Mean Change From Baseline to Day 169 in High Sensitivity C-Reactive Protein (Hs-CRP)|hs-CRP is a acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA). Levels of hs-CRP can be used to determine DAS28.|BL, Day 169|All treated participants||mg/dL||Standard Deviation|Mean
707641|NCT00124982|Secondary|Short-term Period: Mean Time-matched Change From Baseline (Day 0) in DAS 28 Through 6 Month Open-Label|The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). Time-matched mean change from BL= Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL (Day 0) value for only that cohort of participants with measurements available at that post-BL visit.|BL (Day 0), Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169|All treated participants. n=number of evaluable participants.||units on a scale||Standard Deviation|Mean
707642|NCT00124982|Secondary|Short-term Period: Mean Time-matched Baseline (Day 0) DAS 28 and DAS 28 for Post-Baseline Visits Through 6 Month Open-Label|The DAS 28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). Time-matched baseline (Day 0) values and post-baseline values were presented for each post-baseline visit, and represent only that cohort of participants with measurements available at that post-baseline visit.|BL (Day 0), Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169|All treated participants. n=number of evaluable participants.||units on a scale||Standard Deviation|Mean
707643|NCT00124982|Primary|Short-term Period: Number of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Responses by Enzyme-Linked Immunosorbant Assay (ELISA)|Serum samples from all treated adult participants with active rheumatoid arthritis (RA) were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.|Days 1-169|Treated participants with available serum samples for assay||participants|||Number
707644|NCT00124982|Primary|Short-term Period: Mean Change From Baseline in Systolic and Diastolic Blood Pressure||Day 1 (Baseline) -Day 169|Although mean values for systolic and diastolic blood pressure were recorded, mean changes from baseline were not summarized for these data.||mm Hg||Standard Deviation|Mean
707645|NCT00124982|Primary|Short-term Period: Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria|Marked abnormality criteria: serum glucose (Glu):<65 mg/dL/ >220 mg/dL; fasting serum Glu: <0.8* LLN/>1.5* ULN, or if BL<LLN then use 0.8* BL or >ULN, or if BL>ULN then use >2.0* BL or <LLN; total protein: <0.9* LLN/>1.1* ULN; albumin: <0.9* LLN,or if BL<LLN then use <0.75 BL; uric acid: >1.5* ULN, or if BL>ULN then use >2* BL. Urinalysis (Urine protein, urine Glu, urine blood, leukocyte esterase, Red Blood Cells [RBCs], White Blood Cells [WBCs]):Use ≥2 when BL value missing or value ≥4,or when pre-dose=0 or 0.5. Use ≥3 when pre-dose=1. Use ≥4 when pre-dose=2 or 3|Days 1-169|All treated participants. n=number of participants with evaluable laboratory results.||participants|||Number
707646|NCT00124982|Primary|Short-term Period: Number of Participants With Electrolyte Laboratories Meeting MA Criteria|Marked abnormality criteria:Sodium (Na): <0.95* LLN/ >1.05* ULN,or if BL<LLN then use 0.95* BL or >ULN,or if BL>ULN then use>1.05* BL or <LLN; potassium (K): <0.9* LLN/>1.1* ULN,or if BL<LLN then use 0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; chloride: <0.9* LLN/>1.1* ULN, or if BL<LLN then use 0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; calcium (Ca): <0.8* LLN/>1.2* ULN, or if BL<LLN then use 0.75* BL or >ULN, or if BL>ULN then use>1.25* BL or <LLN; phosphorous (P): <0.75* LLN/ >1.25* ULN, or if BL<LLN then use 0.67* BL or >ULN, or if BL>ULN then use>1.33* BL or <LLN|Days 1-169|All treated participants. n=number of participants with evaluable laboratory results.||participants|||Number
707647|NCT00124982|Primary|Short-term Period: Number of Participants With Liver and Kidney Function Laboratories Meeting MA Criteria|Marked abnormality criteria: Alkaline phosphatase (ALP): >2* ULN, or if BL>ULN then use >3* BL; aspartate aminotransferase (AST): >3* ULN, or if BL>ULN then use >4* BL; alanine aminotransferase (ALT): >3* ULN, or if BL>ULN then use >4* BL; G-Glutamyl transferase (GGT): >2* ULN, or if BL>ULN then use >3* BL; Bilirubin: >2* ULN, or if BL>ULN then use >4* BL; blood urea nitrogen (BUN): >2* BL; creatinine: >1.5* BL|Days 1-169|All treated participants. n=number of participants with evaluable laboratory results.||participants|||Number
707924|NCT00128180|Primary|Number of Participants With SAEs|The Number of participants with SAEs|6 months|Per protocol, safety analysis inluded all participants, including those where hantavirus infection was not confirmed.||participants|||Number
707648|NCT00124982|Primary|Short-term Period: Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria|Upper Normal Limit (ULN), Lower Normal Limit (LLN), Baseline (BL). Marked abnormality criteria are: Hemoglobin (HGB): >3 g/dL decrease from BL; Hematocrit: <0.75 * BL; Erythrocytes: <0.75 * BL; Platelets (PLT): <0.67 * LLN/>1.5 * ULN, or if BL < LLN then use 0.5 * BL/<100,000 mm^3; Leukocytes: <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL/>ULN, or if BL>ULN then use >1.2 * BL/<LLN; neutrophils+bands: <1.0 * 10^3 c/uL; eosinophils: >0.750 * 10^3 c/uL; basophils: > 400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750 * 10^3 c/uL/ >7.50 * 10^3 c/uL.|Days 1-169|Participants who received at least 1 infusion of abatacept during the short-term treatment period||participants|||Number
707649|NCT00124982|Secondary|Short-term Period: Number of Participants With Clinically Meaningful Improvement (CMI) in Disease Activity Score (DAS 28), Low Disease Activity (LDAS), or Remission at Day 169|The DAS 28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). A clinically significant response= decrease in DAS28 score of >1.2 from baseline.|BL, Day 169|All treated participants.||participants|||Number
707650|NCT00124982|Primary|Short-term Period: Number of Participants With AEs of Special Interest|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).|Days 1-169|All treated participants||participants|||Number
707651|NCT00124982|Primary|Short-term Period: Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuations, AEs, Related AEs, or AEs Leading to Discontinuations|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with treatment.SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.Related AE/SAE=Certain,Probable,Possible,or Missing relationship to Drug|Days 1-169|All treated participants||participants|||Number
707652|NCT00125034|Secondary|Safety - Number of Patients Experiencing Any Adverse Event|Please refer to Adverse Events section for further details|time from first dose up to 30 after last dose of study treatment, reported between day of first patient dose of study treatment, 27 Jul 2005, until cut-off date 30 Nov 2008|Safety Population||participants|||Number
707653|NCT00125034|Secondary|Duration of Response|"Time from first assessment of Complete Response or Partial Response to disease progression or death (within 60 days of last tumor assessment).
Patients without event are censored on the date of last tumor assessment. Tumor assessments based on modified WHO criteria."|Time from first assessment of Complete Response or Partial Response to disease progression,death or last tumor assessment, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 01 Mar 2007|Primary analysis on ITT population i.e. all randomized subjects who have received at least one dose of randomized treatment (allocation to treatment groups as randomized).||months||95% Confidence Interval|Median
707654|NCT00125034|Secondary|Disease Control Rate (Cut Off Date 4 August 2006)|The disease control rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response + Stable Disease as best overall response according to radiological assessments as assessed by IRC (based on modified WHO criteria).|Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 4 August 2006|Primary analysis on ITT population i.e. all randomized subjects who have received at least one dose of randomized treatment (allocation to treatment groups as randomized).||percentage of participants||95% Confidence Interval|Number
707655|NCT00125034|Secondary|Participants With No Residual Tumor After Metastatic Surgery|No residual tumor after on-study surgery for metastases.|Time from first dose up to 30 days after the last dose of study treatment, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 November 2008|Primary analysis on ITT population i.e. all randomized subjects who have received at least one dose of randomized treatment (allocation to treatment groups as randomized).||participants|||Number
707656|NCT00125034|Secondary|Overall Survival Time (KRAS Mutant Population)|Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.|Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 November 2008|KRAS Mutant population||months||95% Confidence Interval|Median
707657|NCT00125034|Secondary|Overall Survival Time (KRAS Wild-Type Population)|Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.|Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 November 2008|KRAS Wild-Type population||months||95% Confidence Interval|Median
707658|NCT00125034|Secondary|Overall Survival Time|Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.|Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 Nov 2008|Primary analysis on ITT population i.e. all randomized subjects who have received at least one dose of randomized treatment (allocation to treatment groups as randomized).||months||95% Confidence Interval|Median
707659|NCT00125034|Secondary|Progression-free Survival Time (KRAS Mutant Population)|"Duration from randomization until radiological progression as assessed by an IRC (based on modified WHO criteria) or death due to any cause.
Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment."|Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 Nov 2008|KRAS Mutant population||months||95% Confidence Interval|Median
707660|NCT00125034|Secondary|Progression-free Survival Time (KRAS Wild-Type Population)|"Duration from randomization until radiological progression as assessed by an IRC (based on modified WHO criteria) or death due to any cause.
Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment."|Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 Nov 2008|KRAS Wild-Type population||months||95% Confidence Interval|Median
707661|NCT00125034|Secondary|Progression-free Survival Time|"Duration from randomization until radiological progression as assessed by an IRC (based on modified WHO criteria) or death due to any cause.
Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment."|Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 01 Mar 2007|Primary analysis on ITT population i.e. all randomized subjects who have received at least one dose of randomized treatment (allocation to treatment groups as randomized).||months||95% Confidence Interval|Median
707662|NCT00125034|Secondary|Best Overall Response Rate (KRAS Mutant Population)|The best overall response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified WHO criteria) as assessed by an IRC.|Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 1 Mar 2007|KRAS Mutant population||percentage of participants||95% Confidence Interval|Number
707663|NCT00125034|Secondary|Best Overall Response Rate (Chinese V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Wild-Type Population)|The best overall response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified WHO criteria) as assessed by an IRC.|Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 1 Mar 2007|KRAS Wild-Type population||percentage of participants||95% Confidence Interval|Number
707664|NCT00125034|Primary|Best Overall Response Rate - Independent Review Committee (IRC)|The best overall response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified World Health Organisation (WHO) criteria) as assessed by an IRC.|Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 4 August 2006|Primary analysis on the Intent to Treat (ITT) population i.e. all randomized subjects who have received at least one dose of randomized treatment (allocation to treatment groups as randomized).||percentage of participants||95% Confidence Interval|Number
707665|NCT00125138|Secondary|Investigator/Caregiver Evaluations of Motor Function|The change in the motor section of the Unified Parkinson’s Disease Rating Scale (UPDRS III - motor exam) score. Scores on the UPDRS III - motor exam range from 0 to 108, with higher scores indicating more severe motor symptoms.|6 weeks (from Baseline to end of Maintenance Period)|All randomized subjects who provided informed consent, took at least 1 dose of study drug, and had at least 1 post-baseline efficacy measurement (modified intent-to-treat [MITT] population) were included in the analysis of efficacy.||Scores on a scale||Standard Deviation|Mean
707666|NCT00125138|Primary|Patient Evaluation of Symptoms of Psychosis.|The change in the Scale for Assessment of Positive Symptoms (SAPS) total score. The SAPS total score ranges from 0 to 170, with higher scores indicating more severe psychosis.|6 weeks (from Baseline to end of Maintenance Period)|All randomized subjects who provided informed consent, took at least 1 dose of study drug, and had at least 1 post-baseline efficacy measurement (modified intent-to-treat [MITT] population) were included in the analysis of efficacy.||Scores on a scale||Standard Error|Least Squares Mean
707667|NCT00125164|Post-Hoc|Change From Baseline in Height Standard Deviation (SD) Score at One Year - Completers|Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement. Please note that Standard Deviation (SD) Score is a term used in growth studies. The SD Score is calculated as the patient value minus the mean divided by the standard deviation. The mean and the standard deviation vary depending on the age and sex of the child.|One Year|All randomized subjects who completed 12 months of treatment in the untreated control, 80 and 120 µg/kg BID groups with a baseline height measurement and at least one on-treatment height measurement. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID.||SD/year||Standard Deviation|Mean
707668|NCT00125164|Post-Hoc|Height Velocity During the First Year for Subjects - Completers|Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement.|One Year|All randomized subjects who completed 12 months of treatment in the untreated control, 80 and 120 µg/kg BID groups with a baseline height measurement and at least one on-treatment height measurement. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID.||cm/year||Standard Deviation|Mean
707669|NCT00125164|Secondary|IGF Generation Test: Change of Serum IGFBP-3 After 7 Days Exposure to Recombinant Human Growth Hormone (rhGH)|Blood drawn at Study Day 1, followed by 7 days of rhGH daily dosing at 0.05 mg/kg of body weight. Additional blood draw at Study Day 7.|Study Day 1 and Day 7|All randomized subjects in the untreated control, 80 and 120 µg/kg BID groups with measurements both pre and post exposure to rhGH. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID.||mg/dL||Standard Deviation|Mean
707670|NCT00125164|Secondary|IGF Generation Test: Change of Serum IGF-1 After 7 Days Exposure to Recombinant Human Growth Hormone (rhGH)|Blood drawn at Study Day 1, followed by 7 days of rhGH daily dosing at 0.05 mg/kg of body weight. Additional blood draw at Study Day 7.|Study Day 1 and Day 7|All randomized subjects in the untreated control, 80 and 120 µg/kg BID groups with measurements both pre and post exposure to rhGH. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID.||ng/mL||Standard Deviation|Mean
708606|NCT00138151|Secondary|The Effect of the Regimen on Bcl-2 Family Proteins in Biopsy Specimens and Correlation With Peripheral Blood Mononuclear Cell Bcl-2 Levels.||8 years|Study was closed prematurely due to slow accrual and lack of study drug. Insufficient accrual to evaluate response rate.|||||
707671|NCT00125164|Secondary|Percent Changes From Baseline in Serum Concentrations of Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) at One Year|Blood sample was collected while subject is in a fasting state for measuring the level of IGFBP-3 in the growth factor panel.|Measured at baseline and at one year|All randomized subjects in the untreated control, 80 and 120 µg/kg BID groups with baseline measurement and Month 12 measurement. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID.||Percent change||Standard Deviation|Mean
707672|NCT00125164|Secondary|Percent Changes From Baseline in Serum Concentrations of Insulin-like Growth Factor Binding Protein-2 (IGFBP-2) at One Year|Blood sample was collected for measuring the level of insulin-like growth factor binding protein-2 (IGFBP-2) in the growth factor panel.|Measured at baseline and at one year|All randomized subjects in the untreated control, 80 and 120 µg/kg BID groups with baseline measurement and Month 12 measurement. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID.||Percent change||Standard Deviation|Mean
707673|NCT00125164|Secondary|Percent Changes From Baseline in Serum Concentrations of IGF-2 at One Year|Blood sample was collected for measuring the level of IGF-2 in the growth factor panel.|Measured at baseline and at one year|All randomized subjects in the untreated control, 80 and 120 µg/kg BID groups with baseline measurement and Month 12 measurement. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID.||Percent change||Standard Deviation|Mean
707674|NCT00125164|Secondary|Percent Changes From Baseline in Serum Concentrations of IGF-1 at One Year|Blood sample was collected while subject is in a fasting state for measuring the level of IGF-1 in the growth factor panel.|Measured at baseline and at one year|All randomized subjects in the untreated control, 80 and 120 µg/kg BID groups with baseline measurement and Month 12 measurement. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID.||Percent change||Standard Deviation|Mean
707675|NCT00125164|Secondary|Changes in Bone Age From Baseline to One Year|Plain X-rays of the left hand and wrist exposed for bone age appraisal. The films are sent to a central facility for standardized evaluation.|Measured at baseline and at one year|All randomized subjects in the untreated control, 80 and 120 µg/kg BID groups with baseline measurement and Month 12 measurement. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID.||Year||Standard Deviation|Mean
707676|NCT00125164|Secondary|Change From Baseline in Height Standard Deviation (SD) Score at One Year - ITT Population|Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement. Please note that Standard Deviation (SD) Score is a term used in growth studies. The SD Score is calculated as the patient value minus the mean divided by the standard deviation. The mean and the standard deviation vary depending on the age and sex of the child.|Measured at baseline and at one year|A modified intention-to-treat population that consists of all randomized subjects in the untreated control, 80 and 120 µg/kg BID groups with a baseline height measurement and at least one on-treatment height measurement. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID.||SD/year||Standard Deviation|Mean
707677|NCT00125164|Primary|Height Velocity During the First Year - Intent to Treat (ITT)Population|Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement.|Measured at baseline and at one year|A modified intention-to-treat population consisting of all randomized subjects in the untreated control, 80 and 120 µg/kg BID groups with a baseline height measurement and at least one on-treatment height measurement. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID.||cm/yr||Standard Deviation|Mean
707678|NCT00125190|Post-Hoc|Increase in Height Velocity Over the Study Period 34 - 86 Weeks [Completers]|Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement.|Weeks 34 - 86|The ITT principle was used for the primary analysis, with imputation of missing height velocity and missing height SD score. Only subjects completing Week 86 were included in the analysis.||cm/yr||Standard Deviation|Mean
707679|NCT00125190|Post-Hoc|Increase in Height Velocity Over the Study Period 0 - 34 Weeks [Completers]|Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement.|Weeks 0 -34|The ITT principle was used for the primary analysis, with imputation of missing height velocity and missing height SD score. Only subjects completing Week 34 were included in the analysis.||cm/yr||Standard Deviation|Mean
707680|NCT00125190|Secondary|rhIGF-1 Doses Required to Achieve the Serum IGF-1 Targets With Measures Taken at Each Study Visit||34, 52 and 86 weeks||||||
707681|NCT00125190|Secondary|Percent Changes in Serum Concentration of Acid Labile Subunit (ALS) From Baseline to Week 86|Blood sample was collected while subject is in a fasting state for measuring the level of Serum Concentration of Acid Labile Subunit (ALS).|86 weeks|Subjects who had both baseline and week 86 measurements were included in the analysis.||percent||Full Range|Median
707682|NCT00125190|Secondary|Percent Changes in Serum Concentration of Insulin-like Growth Factor Binding-3 (IGFBP-3) From Baseline to Week 86|Blood sample was collected while subject is in a fasting state for measuring the level of IGFBP-3 in the growth factor panel.|86 weeks|Subjects who had both baseline and week 86 measurements were included in the analysis.||percent||Full Range|Median
707683|NCT00125190|Secondary|Percent Changes in Serum Concentration of Insulin-like Growth Factor Binding-2 (IGFBP-2) From Baseline to Week 86|Blood sample was collected while subject is in a fasting state for measuring the level of IGFBP-2 in the growth factor panel.|86 weeks|Subjects who had both baseline and week 86 measurements were included in the analysis.||percent||Full Range|Median
707684|NCT00125190|Secondary|Percent Changes in Serum Concentration of Insulin-like Growth Factor Binding-1 (IGFBP-1) From Baseline to Week 86|Blood sample was collected while subject is in a fasting state for measuring the level of IGFBP-1 in the growth factor panel.|86 weeks|Subjects who had both baseline and week 34 measurements were included in the analysis.||percent||Full Range|Median
714105|NCT00229957|Secondary|HOME Falls and Accident Screening Tool (FAST)|This is a home assessment of safety hazards for falls present in the individual's home. This tool helps to identify seniors at risk of falls. Score 0-25.|baseline, 15 months||08/2009||||
707685|NCT00125190|Primary|Height Velocity Over the Study Period 34 - 86 Weeks [Intent to Treat Population]|Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement.|Weeks 34 to 86|The ITT principle was used for the primary analysis, with imputation of missing height velocity and missing height SD score. Only subjects continuing past Week 34 were included in the analysis.||cm/yr||Standard Deviation|Mean
707686|NCT00125190|Secondary|Bone Age - Change From Pretreatment Minus Change in Chronological Age Over the Study Period 0 - 86 Weeks [Intent to Treat Population]|Plain X-rays of the left hand and wrist exposed for bone age appraisal. The films are sent to a central facility for standardized evaluation.|Weeks 0 - 86|Subjects who had both baseline and week 86 measurements were included in the analysis.||years||Standard Deviation|Mean
707687|NCT00125190|Secondary|Changes in Height Standard Deviation (SD) Score Over the Study Period 34 - 86 Weeks|Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement. Please note that Standard Deviation (SD) Score is a term used in growth studies. The SD Score is calculated as the patient value minus the mean divided by the standard deviation. The mean and the standard deviation vary depending on the age and sex of the child.|Weeks 34 - 86|The ITT principle was used for the primary analysis, with imputation of missing height velocity and missing height SD score. Only subjects continuing past Week 34 were included in the analysis.||SDs||Standard Deviation|Mean
707688|NCT00125190|Secondary|Changes in Height Standard Deviation (SD) Score Over the Study Period 0 - 34 Weeks [Intent to Treat Population]|Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement. Please note that Standard Deviation (SD) Score is a term used in growth studies. The SD Score is calculated as the patient value minus the mean divided by the standard deviation. The mean and the standard deviation vary depending on the age and sex of the child.|Weeks 0 - 34|The ITT principle was used for the primary analysis, with imputation of missing height velocity and missing height SD score.||SDs||Standard Deviation|Mean
707689|NCT00125190|Primary|Height Velocity Over the Study Period 0 - 34 Weeks [Intent to Treat Population]|Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement.|34 weeks|The ITT principle was used for the primary analysis, with imputation of missing height velocity and missing height SD score.||cm/yr||Standard Deviation|Mean
707690|NCT00125242|Primary|Word Retrieval Accuracy|"Accuracy of naming of pictured treated and untreated items was assessed in probes conducted separate from treatment. Probes were conducted repeatedly throughout the study, from baseline (prior to treatment) to follow-up (6 weeks following treatment). All naming responses were scored using a 0-10 scale reflecting promptness and presence of errors; scores of 8-10 received an accuate score and scores of 0-7 received an inaccurate score. A percentage accuracy score was calculated for each experimental set of items for every probe session. Baseline probe scores were compared to end of treatment and follow-up probe scores to obtain individual effect sizes for each experimental list of items for each participant (i.e., several effect sizes were calculated for each participant). All effect sizes were utlized to obtain an average effect size for each participant; these averages were then utlized to obtain a group average."|End of treatment and at 6 weeks post treatment|SFA Treatment Participants were stroke-survivors with chronic aphasia who had significant word retrieval difficulties. Non Treatment Stimuli Development Participants were only enrolled in the study to provide data for the development of treatment stimuli. As such, they were not assessed for the outcome measure.||d-index (effect size)|Participants|Standard Deviation|Mean
707691|NCT00125268|Secondary|Percentage of Subjects That Have an Improvement of Two Points or More on the SF-8 at the End of Four Weeks of Treatment|The SF-8 Health Survey has 8 questions, each question measuring each of the eight domains of health. Scores are calibrated so that 50 is the average score or norm. A lower score indicates poorer health, and a higher score indicates excellent health.|baseline, 4 weeks||||||
707692|NCT00125268|Secondary|Percentage of Subjects That Have a Forty Percent Reduction of Pain Measured by the Neuropathic Pain Scale at the End of Four Weeks of Treatment|The neuropathic pain scale consists of 10 questions with individual answers rated from 1 to 10, with 0 = no pain to 10 = the most intense pain imaginable. The overall score could range from 0 to 100, with 0 = no pain to 100 = the most intense pain imaginable.|baseline, 4 weeks||||||
707693|NCT00125268|Primary|Percentage of Subjects That Have a Greater Than or Equal to Forty Percent Decrease on the Visual Analog Pain Scale at the End of Four Weeks of Treatment|Pain was measured by a 10 cm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes. On this scale 0 means no pain and 10 cm means extreme pain. The investigator measures the mark made by the subject in cm and records this for the value of pain.|baseline, 4 weeks||||||
707694|NCT00125515|Primary|Retention in Treatment|The number of participants who were retained and completed all 12 weeks of treatment and study participation were compared between the three study groups.|Number of participants who complete 12 weeks of treatment|All analysis were conducted based on intent-to-treat principle.||participants|||Number
707695|NCT00125528|Secondary|McGill Pain Questionnaire (MPQ)|Change in MPQ score after 6 weeks of treatment as compared to baseline. The MPQ score uses a Pain Rating Index from 0 to 20 where 0 is evidence of no pain and 20 indicates the highest pain possible. A lower score is also indicative of a lower quality of pain. Thus, a larger negative number indicates positive change and therefore higher efficacy.|6 weeks|||units on a scale||Standard Deviation|Mean
707696|NCT00125528|Primary|Change in Numeric Rating Scale (NRS-11)|Change in NRS score after 6 weeks of treatment as compared to baseline. The numeric rating scale is an 11-point rating scale wherein participants rated their current lower back pain intensity on a scale from 0 to 10, with 0 meaning no pain and 10 being the worst pain possible. Thus, a larger negative number indicates positive change and a higher efficacy.|6 weeks|||units on a scale||Standard Deviation|Mean
707792|NCT00120523|Secondary|Vital Signs and Physical Examinations: Pulse|Significant findings are included in the relevant medical history/current medical conditions (prior to study start) or in the AE documentation (after study start.|throughout the 5-year study|Safety/intent-to-treat (ITT) - all randomized patients who received at least one application of study medication.Patients who do not have baseline value are excluded from analysis.||bpm||Standard Deviation|Mean
707697|NCT00125593|Secondary|End-stage Renal Disease Among All Patients Not on Dialysis at the Time of Randomization to Simvastatin Plus Ezetimibe Versus Placebo|End-stage renal disease was defined as initiation of maintenance dialysis or renal transplantation. Temporary dialysis was excluded. All potential dialysis and transplant events were adjudicated, using pre-specified objective criteria, by clinicians blinded to study treatment allocation and lipid levels. Numbers provided = number of patients with events.|Median follow-up 4.9 years|||participants|||Number
707698|NCT00125593|Secondary|Coronary or Non-coronary Revascularization Among All Patients Ever Randomized to Simvastatin Plus Ezetimibe Versus All Patients Allocated to Placebo|Revascularization included any arterial revascularization procedure, whether surgical or percutaneous, but excluded revascularization performed for hemodialysis vascular access (e.g. fistuloplasty) or to the donor kidney transplant artery. Revascularization included amputations for vascular disease (rather than for trauma or infection). All potential revascularization events (including angiography) were adjudicated, using pre-specified objective criteria, by clinicians blinded to study treatment allocation and lipid levels. Numbers provided = number of patients with events.|Median follow-up 4.9 years|||participants|||Number
707699|NCT00125593|Secondary|Non-hemorrhagic Stroke Among All of Patients Ever Randomized to Simvastatin Plus Ezetimibe Versus All Patients Allocated to Placebo|Stroke was defined as rapid onset of focal or global neurological deficit, with duration greater than 24 hours. Clinical notes and brain imaging were sought to determine the stroke etiology, and if the stroke was fatal and post-mortem examination findings were available, this information was also assessed. All potential stroke events (including transient ischemic attack and intracerebral hemorrhage) were adjudicated, using pre-specified objective criteria, by clinicians blinded to study treatment allocation and lipid levels. Numbers provided = number of patients with events.|Median follow-up 4.9 years|||participants|||Number
707700|NCT00125593|Secondary|Major Coronary Events Among All Patients Ever Randomized to Simvastatin Plus Ezetimibe Versus All Patients Allocated to Placebo|Major coronary events defined as coronary death or non-fatal myocardial infarction. Myocardial infarction adjudicated based on the presence of serial changes in cardiac biomarkers (e.g. troponin, creatine kinase), typical ECG changes and typical cardiac symptoms. If myocardial infarction was fatal and post-mortem examination findings were available, this information was also assessed. All potential coronary events were adjudicated, using pre-specified objective criteria, by clinicians blinded to study treatment allocation and lipid levels. Numbers provided = number of patients with events.|Median follow-up 4.9 years|||participants|||Number
707701|NCT00125593|Secondary|Major Vascular Events Analyzed Amongst Patients Initially Randomized to Simvastatin Plus Ezetimibe Versus Placebo (Original Protocol-defined Primary Outcome)|Major vascular events defined as non-fatal myocardial infarction or cardiac death, any stroke, or any arterial revascularization procedure (excluding dialysis access procedures). Numbers provided = number of patients with events.|Median follow-up 4.9 years|Includes only those patients initially randomized to simvastatin plus ezetimibe versus placebo (as opposed to all patients ever randomized to simvastatin plus ezetimibe versus all patients allocated placebo)||participants|||Number
707702|NCT00125593|Secondary|Major Vascular Events Analyzed Among All Patients Ever Randomized to Simvastatin Plus Ezetimibe Versus All Patients Allocated to Placebo|Major vascular events defined as non-fatal myocardial infarction or cardiac death, any stroke, or any arterial revascularization procedure (excluding dialysis access procedures). Numbers provided = number of patients with events.|Median follow-up 4.9 years|||participants|||Number
707703|NCT00125593|Primary|Key Outcome as Per Statistical Analysis Plan = Major Atherosclerotic Events Among All Patients Ever Randomized to Simvastatin Plus Ezetimibe Versus All Patients Allocated to Placebo|Major atherosclerotic events defined as non-fatal myocardial infarction or coronary death, non-hemorrhagic stroke, or any arterial revascularization procedure (excluding dialysis access procedures). Numbers provided = number of patients with events.|Median follow-up 4.9 years|||participants|||Number
707704|NCT00125619|Secondary|Berg Balance Scale|Clinical measure of balance|4 weeks|||units on a scale||Standard Deviation|Mean
707705|NCT00125619|Secondary|Short Physical Performance Battery|Standardized clinical measure of physical function involving tests of: walking speed, strength (repeated chair rise), and balance. The scale ranges from 0 - 12 points with better physical function as the score approaches 12 points and worse physical function as the score approaches 0 points.|4 weeks|||units on a scale||Standard Deviation|Mean
707706|NCT00125619|Secondary|Lower Extremity Fugl-Meyer Motor Assessment|Standardized clinical measure of motor impairment. The lower extremity (leg) sub-scale ranges from 0 - 35 points, where less impairment corresponds with scores approaching 35 and worse impairment corresponds with scores approaching 0.|4 weeks|||units on a scale||Standard Deviation|Mean
707707|NCT00125619|Secondary|Step Length Ratio (Abs)|measure of step length symmetry, calculated as = ABS [1 - (Pstep length / NPstep length)]|4 weeks|||ratio||Standard Deviation|Mean
707708|NCT00125619|Secondary|Six Minute Walk|distance, in meters, walked overground over a six minute interval.|4 weeks|||meters||Standard Deviation|Mean
707709|NCT00125619|Secondary|Fast Walking Speed|Fastest comfortable walking speed measured while walking overground|4 weeks (s/p 12 training sessions)|||meters/s||Standard Deviation|Mean
707710|NCT00125619|Primary|Self-selected Overground Walking Speed|Overground walking speed determined as rate of walking over a 10 meter distance.|4 weeks (s/p 12 sessions of locomotor training)|||meters/s||Standard Deviation|Mean
707711|NCT00125658|Secondary|Movement Smoothness|"Movement smoothness is determined by assessing the number of sub movements (i.e., starts and stops) that can be identified during performance of a task. Here the task was reach-to-grasp. Sub movement are identified from kinematics/3D motion analysis. Sub-movements represent discontinuities or jerky movements. For example, skilled reaching is smooth and may reveal a single movement unit; in contrast, unskilled movements will reveal multiple movement units (i.e., starts and stops). As a performer practices and learns the movement, the number of sub movements is reduced. Sub movements can also present in persons with pathology. The unit of sub movements is whole numbers, or counts, of the sub movements. Data are change scores, expressed relative to baseline."|baseline, 10 weeks, 20 weeks|||sub movements||Standard Deviation|Mean
707712|NCT00125658|Secondary|Movement Accuracy (Reach Path Ratio, RPR)|Measure is derived from kinematics/motion analysis. RPR = ratio of actual reach trajectory relative to an idealized straight line. Data are change scores, expressed relative to baseline.|baseline, 10 weeks, 20 weeks|||ratio||Standard Deviation|Mean
707832|NCT00126776|Primary|Hospitalization or Emergency Department Visit for COPD||1 yr||||||
707713|NCT00125658|Primary|Upper-extremity Fugl-Meyer Motor Assessment|The Fugl-Meyer Motor Assessment is a standardized scale used to measure the magnitude of motor impairment (severity) following stroke. There are separate sub-scales for the upper and lower extremities. Here we used the upper-extremity component; the full range of the scale is 0 - 66 points. Higher scores approaching 66 represent better, and lower scores approaching 0 worse, motor function. There is a significant ceiling effect with the FMA, thus a score of 66 points does not mean an individual with stroke has fully recovered. Data are change scores expressed relative to baseline.|baseline, 10 weeks, 20 weeks|||units on a scale||Standard Deviation|Mean
707714|NCT00125658|Secondary|Movement Speed|peak velocity of movement (cm/s) during reach-to-grasp, obtained using kinematics/motion capture. Data are change scores expressed relative to baseline.|baseline, 10 weeks, 20 weeks|||cm/s||Standard Deviation|Mean
707715|NCT00125658|Primary|Change in Elbow Extension Range of Motion|joint range of motion obtained using kinematics / motion capture. Change scores are expressed relative to baseline.|baseline, 10 weeks, 20 weeks|||degrees||Standard Deviation|Mean
707716|NCT00125658|Primary|Change in Shoulder Flexion|joint range of motion obtained using kinematics / motion capture. Change scores expressed relative to baseline.|baseline, 10 weeks, 20 weeks|||degrees||Standard Deviation|Mean
707717|NCT00125658|Primary|Change in Trunk Displacement|Distance (in cm) of trunk lean while performing reach-to-grasp. This information is obtained from kinematics/3D motion capture and is used to inform regarding compensatory use of the trunk as compared to active motion of the shoulder, elbow, wrist, and hand, during reach-to-grasp. Change scores are expressed relative to baseline.|baseline, 10 weeks, 20 weeks|||centimeters||Standard Deviation|Mean
707718|NCT00125931|Secondary|YMRS Scores|Assessment of current mania symptoms using YMRS. All questions have a 0 (absent)-4(most severe) range for describing mania symptoms. The mean YMRS scores were reported, with the total ranging from 0-44. A higher total score indicates a greater number of symptoms and higher symptom intensity, while a smaller score indicates a lesser number of symptoms and higher lower intensity.|Each morning of the three-day study|||units on a scale||Standard Deviation|Mean
707719|NCT00125931|Primary|Mania Symptoms Using MACS|Assessment of current mania symptoms using Mania Acute Change Scale (MACS). All 20 questions on the scale have a 0 (absent)-4(most severe) range for describing mania symptoms. The mean MACS score totals were reported, with the total ranging from 0-80. A higher total score indicates a greater number of symptoms and higher symptom intensity, while a smaller score indicates a lesser number of symptoms and higher lower intensity.|hourly for 6 hours after first dose of pentazocine; hour 0 is the baseline score and also when first dose of pentazocine was administered|||units on a scale||Full Range|Mean
707720|NCT00125957|Primary|Hamilton Depression Rating Scale (HAM-D)|Median total depression ratings at baseline and follow-up using the HAM-D. The scale consists of 21 questions that assess depression symptoms. Questions 1-3, 7-11, 15, and 19 are rated on a scale of 0-4, with 0 being not present to and 4 being severe. Questions 4, 5, 12 - 14, 16-18 and 21 are rated from 0-2 with a score of 0 signifying the symptom is absent and a score of 2 as most severe. Item 20 is score on a scale of 0-3 with the same pattern of severity as all other questions. The total score for the HAM-D ranges from 0-63.|Baseline and follow-up|||units on a scale||Full Range|Median
707721|NCT00125957|Primary|Montgomery-Asberg Depression Rating Scale (MADRS)|Median total depression symptoms rating at baseline and follow-up visits. The MADRS consists o 10 questions assessing depression symptoms. All questions are scored on a 0-6 severity scale, with 0 being absent and 4 being most severe. Total scores can range from 0-60.|Baseline and follow-up|||units on a scale||Full Range|Mean
707722|NCT00126113|Secondary|International Outcome Inventory for Hearing Aids (IOI-HA)|The IOI-HA is a seven-item questionnaire for which hearing-aid use, hearing-aid benefit, residual activity limitation, hearing-aid satisfaction, residual participation restriction, impact on others, and quality of life are rated on a five-point scale. An overall IOI-HA score is generated by averaging responses to all seven items. Higher scores reflect better self-reported outcome. Scores can range from 7 (poorest outcome) to 35 (best outcome).|Day 70 (end of study)|||units on a scale||Standard Deviation|Mean
707723|NCT00126113|Secondary|Abbreviated Profile of Hearing Aid Benefit (APHAB)|APHAB: The APHAB is a 24-item questionnaire that documents hearing difficulties in specified listening situations. Items are answered on a seven-point scale from ‘ Always ’ to ‘ Never ’ with higher scores indicating greater reported hearing disability. The questionnaire has four subscales: Ease of communication, Reverberation, Background noise, and Aversiveness, from which a global score is computed by averaging the Ease of communication, Reverberation, and Background noise scale scores. Questions are answered for unaided and aided listening. By subtracting aided scores from unaided scores a measure of reported aided benefit is obtained. Scores can range from 0 (no disability) to 99 (maximum disability).|Day 70 (end of study)|||units on a scale||Standard Deviation|Mean
707724|NCT00126113|Secondary|Hearing Handicap Inventory (HHI)|HHI: The HHI for the elderly is for individuals over age 65 years; the HHI for adults is for individuals aged 65 years and younger. Both are 25-item questionnaires that assess the social and emotional consequences of hearing loss. The versions differ in the wording of three questions. Items are answered on a scale of Yes (4 points), Sometimes (2 points), and No (0 points) with higher scores indicating greater reported hearing handicap. Scores can range from 0 (no handicap) to 100 (maximum handicap).|Day 70 (end of study)|||units on a scale||Standard Deviation|Mean
707725|NCT00126113|Primary|Psychosocial Impact of Assistive Devices Scale (PIADS)|PIADS: The PIADS measures the psychosocial impact of any assistive device(s). Here that is a hearing aid. The PIADS is a 26-item self-rating scale. The user rates each item on a seven-point scale that ranges from negative 3 (maximum negative impact) to positive 3 (maximum positive impact). The midpoint, zero, indicates no impact or no perceived change resulting from device use. It measures three quality-of-life domains: (1) Adaptability that reflects the inclination or motivation to participate socially and take risks; (2) Competence that reflects perceived functional capability, independence, and performance; and (3) Self-esteem that reflects self-confidence, self esteem, and emotional well-being.|Day 70 (end of study) only|||units on a scale||Standard Deviation|Mean
707833|NCT00127036|Secondary|Number of Participants With Serious Adverse Events (SAEs)|Review of Serious Adverse Events (SAEs) To assess the toxicity associated with Arms A and B. Response rates and toxicity rates for each arm were to be estimated and exact (using Casella’s method) 95% confidence intervals for those proportions computed. With the anticipated 75 patients in each arm, these estimated proportions would have standard errors not exceeding 7%.|30 Days After End of Treatment - Average of 6 Months|All participants.||participants|||Number
707726|NCT00126126|Secondary|Six-minute Walk Test|The six-minute walk test (6MWT) is a measure of overall functional mobility, and cardiopulmonary and musculoskeletal endurance. It assesses the distance ambulated in 6 minutes. The 6MWT has excellent reliability for lower limb amputees and can differentiate between amputee Medicare Functional Classification Levels (MFCL).Lower limb amputees functioning at the K2 level ambulate a mean distance of 200 meters. Those at the K3 level ambulate a mean distance of 300 meters. Those at the K4 level ambulate a mean distance of 400 meters. Service Members with traumatic lower limb loss ambulate a distance of 600 meters. The minimal detectable change for the 6MWT is 45 meters.|8 weeks for intervention and wait list control group|Repeated Measures ANOVA||meters||Standard Deviation|Mean
707727|NCT00126126|Primary|Amputee Mobility Predictor|The Amputee Mobility Predictor is a reliable and valid performance-based outcome measure of prosthetic mobility. The AMP is scored from 0-47, higher scores indicating greater prosthetic mobility. The AMP can help clinicians differentiate between different functional K-levels based on as defined by the Medicare Functional Classification Level (MFCL) system. Lower limb amputees functioning at the K2 level score between 27-36 on the AMP and are classified as limited community ambulators. Those at the K3 level score between 37-42 and are typical community ambulators who have the ability to traverse environmental barriers and performing activities that are beyond simple locomotion. Individuals at the K4 level score between 43-47 which is typical of prosthetic demands of an active adult or regular athlete. The minimal detectable change for the AMP is 3.4 points.|8 weeks for intervention and for wait-list control|Repeated Measures ANOVA||Points||Standard Deviation|Mean
707728|NCT00126191|Secondary|Disease Free Survival|Participants are followed after completion of protocol therapy until disease progression to determine disease free survival.|Until disease progression up to 120 months|One low-risk participant was lost to follow-up after 48 months of disease free survival.||Months||Full Range|Mean
707729|NCT00126191|Primary|Response Rates (CR and PR) in Adults With Burkitt/Atypical Burkitt|"Complete Response (CR): Disappearance of all measurable or evaluable disease confirmed.
Partial Response (PR): Reduction of 50% or greater in the sum of the products of the perpendicular diameters of all measurable.
Of 8 High Risk participants, 7 met the primary response outcome. 1 High Risk participant did not meet protocol defined primary outcome response and died two months following enrollment."|3 years|||participants|||Number
707730|NCT00126425|Primary|Relationship Between the Occurrence of Adverse Cardiac Event and 123I-mIBG Uptake on Planar Scintigraphy Categorized as High or Low Heart to Mediastinum (H/M) Ratio|H/M ratio for 123I-mIBG uptake at 3 hours 50 minutes post administration was calculated by dividing the counts/pixel in the total myocardium region of interest (ROI) by the counts/pixel in the 7x7 pixel mediastinal ROI. Assessments were done by 3 independent readers. H/M ratios were categorized as ‘Low’ and ‘High’ based on being <1.6 or ≥1.6 respectively. The efficacy of 123I-mIBG was based on the prognostic value of the imaging data collected relative to time to adverse cardiac events.|Approximately 24 months from the date of administration of 123I-mIBG|Primary efficacy population was 520 participants in HF group who received IMP and had a diagnostic (optimal or sub-optimal) 3 hour 50 minute planar image. Images from 2 HF participants were inadvertently not submitted and not presented to blinded readers. Here, N=efficacy population and n=number of participants assessed by specific readers.||number of adverse cardiac events|||Number
707731|NCT00126438|Primary|Relationship Between the Occurrence of Adverse Cardiac Event and 123I-mIBG Uptake on Planar Scintigraphy Categorized as High or Low Heart to Mediastinum (H/M) Ratio|H/M ratio for 123I-mIBG uptake at 3 hours 50 minutes post administration was calculated by dividing the counts/pixel in the total myocardium region of interest (ROI) by the counts/pixel in the 7x7 pixel mediastinal ROI. Assessments were done by 3 independent readers. H/M ratios were categorized as 'Low' and 'High' based on being <1.6 or ≥1.6 respectively. The efficacy of 123I-mIBG was based on the prognostic value of the imaging data collected relative to time to adverse cardiac events. Data analysis to assess the relative hazard of an adverse cardiac event was performed only on HF participants categorized into 2 groups with H/M <1.6 and H/M ≥1.6 using a Cox proportional hazards model.|Approximately 24 months from the date of administration of 123I-mIBG|Primary efficacy population included 444 participants in HF group who received IMP and had a diagnostic (optimal/sub-optimal) 3 hour 50 minute planar image. Primary efficacy analysis was based on comparing only “Adreview HF” participants with low vs. high H/M and, therefore, did not include “Adreview Control” group.||number of adverse cardiac events|||Number
707732|NCT00126490|Secondary|Number of Participants With Possibly Related Serious Adverse Events (SAEs)|Number of Participants with Serious Adverse Events (SAEs) Possibly Related to Study Treatment. Toxicity as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 3.0|Up to 30 days after completion of treatment|All Participants who received at least one treatment||participants|||Number
707733|NCT00126490|Secondary|Pearson Correlation Coefficients of Dendritic Cell (DC):Immature Cell (ImC) Ratio With DC Function|Dendritic cell (DC) phenotype or functionality. Pearson correlation coefficients of DC:ImC ratio with DC function were to be computed and tested for departure from zero. Those with major responses were to be compared to those without major responses with respect to baseline DC:ImC ratio, baseline DC functional assay, post-treatment DC:ImC ratio and post-treatment DC functional assay using pooled t tests.|At baseline, at days 4-5, 9-10 (of course 1), and at the end of treatment|This was not evaluable because there were not enough samples.|||||
707734|NCT00126490|Secondary|Number of Evaluable Participants With Progression Free Survival (PFS)|Progression Free Survival tabulation at 1 year and at 2 years. Progressive Disease (PD): Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|Up to 2 years|Evaluable participants||participants|||Number
707735|NCT00126490|Secondary|Number of Evaluable Participants With Overall Survival (OS) at 2 Years|Overall Survival tabulation at 2 years from start of treatment.|2 years from start of treatment|Evaluable participants||participants|||Number
707736|NCT00126490|Primary|Number of Evaluable Participants With Complete Response (CR) and Partial Response (PR) at One Year|Major response according to Response Evaluation Criteria In Solid Tumors (RECIST). CR: Disappearance of all target lesions; Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.|1 year|All Participants who received at least one treatment||participants|||Number
708766|NCT00144170|Secondary|Virologic Response at Week 64|Virologic response defined as Viral Load<400 copies/mL|Week 64|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
707737|NCT00126503|Primary|Objective Response|Objective response as determined by RECIST v. 1.0 (measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) > 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions)or last date known alive|Every 8 weeks to date of progression|Patients available for measurement of response to treatment with regimen. 7 Phase I and 4 Phase II patients were not available for measurement of response, respectively: disease progression (5, 2), complicating disease (1, 0), death on-study (1, 0), toxicity (0, 1), and alternative treatment (0, 1). All were counted as clinical progression.||participants|||Number
707738|NCT00126503|Primary|Maximum Tolerated Dose of Bevacizumab in Combination With BAY 43-9006 (Sorafenib)(Phase I)|The highest dose in milligrams (mg) of Bevacizumab in combination with BAY 43-9006 (Sorafenib) while maintaining tolerability. Cohorts of 3-6 patients received escalating doses of sorafenib and bevacizumab until the maximum tolerated dose (MTD) was achieved. The MTD is defined as the dose preceding that at which 2 or more of 6 patients experience dose-limiting toxicity during the initial cycle of therapy. DLTs include absolute neutrophil count (ANC) < 500/mm3 for > 7 days, ANC < 1000/mm3 with fever > 101 degrees Fahrenheit, platelet count < 50,000 mm3, and non-hematologic toxicity Common Toxicity Criteria (CTC) >= Grade 3.|at 28 days|Patients enrolled to determine the safety of BAY 43-9006 (Sorafenib) in combination with Bevacizumab||mg/kg|||Number
707739|NCT00126503|Secondary|Progression-free Survival|Duration of months of progression-free survival (PFS). Determined by months to progressive disease or to last date known alive without progressive disease.|on-study to date of progression or last date known alive without progression|All patients who underwent treatment. No patients in the Phase I cohort moved to the Phase II cohort. No Phase II patients were in the Phase I cohort.||months||Full Range|Median
707740|NCT00126503|Secondary|Overall Survival|Months from date on-study to expired or last date known alive|on-study to date of expired or last date known alive|All treated patients available for determination of overall survival. No patients in the Phase I cohort moved to the Phase II cohort. No Phase II patients were in the Phase I cohort.||months||Full Range|Median
707741|NCT00126503|Primary|Maximum Tolerated Dose (MTD) of BAY 43-9006 (Sorafenib)in Combination With Bevacizumab (Phase I)|The highest dose in milligrams (mg) of BAY 43-9006 (Sorafenib) in combination with Bevacizumab while maintaining tolerability. Cohorts of 3-6 patients received escalating doses of sorafenib and bevacizumab until the maximum tolerated dose (MTD) was achieved. The MTD is defined as the dose preceding that at which 2 or more of 6 patients experience dose-limiting toxicity during the initial cycle of therapy. DLTs include absolute neutrophil count (ANC) < 500/mm3 for > 7 days, ANC < 1000/mm3 with fever > 101 degrees Fahrenheit, platelet count < 50,000 mm3, and non-hematologic toxicity Common Toxicity Criteria (CTC) >= Grade 3.|at 28 days|Patients enrolled to determine the safety of BAY 43-9006 (Sorafenib) in combination with Bevacizumab||mg|||Number
707742|NCT00126555|Primary|Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3)|Severity and timing of toxicities evaluated according to NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 3. Occurrences of late (post-radiation) toxicities that are radiation-related monitored and included.|Up to 5 years|Of 23 enrolled, 1 withdrew, 2 went off study during induction for adverse events and 3 had progressive disease. Of 17 continuing to clinical response assessment (11 on 250 mg/day Induction dose & 6 to 500 mg/day dose escalation), 12 were resectable (2 refused), 2 unresectable and 3 had disease progression leaving only 6 for maintenance.||participants|||Number
707743|NCT00126555|Post-Hoc|Participant Treatment Following Induction Therapy|Treatment received following two 30-day cycles (60 days) of 250 mg gefitinib given by mouth daily. Participant treatment reported as percentage of total treated participants out of total treated.|Following 60 days of Gefitinib induction treatment|||percentage of participants|||Number
707744|NCT00126555|Secondary|Change in Epidermal Growth Factor Receptor (EGFR) and Phospho-Akt Expression||From baseline to up to 30 days||||||
707745|NCT00126555|Secondary|Frequency and Timing of Local and Distant Failures||From study entry to first documented local recurrence or last patient contact, assessed up to 5 years||||||
707746|NCT00126555|Secondary|Clinical Response According to Response Evaluation Criteria In Solid Tumors (RECIST)|Number participants with response defined by RECIST: Complete Response (CR): Disappearance all disease; No new lesions/non-evaluable disease; Responders on none/only maintenance doses of corticosteroids. Partial Response (PR): >/= 50% decrease under baseline in sum products perpendicular diameters of measurable lesions; No progression evaluable disease/new lesions; Responders on same/decreasing doses dexamethasone & stable/improved neurological exams. Stable/No Response (SD): Not qualify for CR, PR, or progression; requires minimum 12 weeks duration; Responders on same/decreasing doses dexamethasone & stable/improved neurological exams. Progression (PD): 25% increase in sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease), OR clear worsening any evaluable disease, OR appearance any new lesion/site, OR failure to return due to death/deteriorating condition. All measurable/evaluable sites assessed using same baseline techniques.|Up to 5 years|One participant of 23 enrolled withdrew prior to treatment.||participants|||Number
707747|NCT00126555|Primary|Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3)|Severity and timing of toxicities evaluated according to NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 3. Occurrences of late (post-radiation) toxicities that are radiation-related monitored and included.|Up to 5 years|Of 23 enrolled, 1 withdrew, 2 went off study during induction for adverse events and 3 had progressive disease. Of 17 continuing to clinical response assessment (11 on 250 mg/day Induction dose & 6 to 500 mg/day dose escalation), 12 were resectable (2 refused), 2 unresectable and 3 had disease progression leaving only 6 for maintenance.||participants|||Number
707748|NCT00126555|Primary|Feasibility Rate|Determined by the surgical healing time (resectable patients) and of concomitant gefitinib by treatment interruption during radiotherapy.|Up to 7 weeks||||||
707834|NCT00127036|Secondary|Number of Participants Per Treatment Arm, With Overall Survival (OS)|Investigators planned to evaluate the overall survival of colorectal cancer (CRC) patients treated with XELOX + bevacizumab (Arm A) or XELIRI + bevacizumab (Arm B).|30 Days After End of Treatment - Average of 6 Months|Low accrual and early termination prevented us from performing the planned analysis. Too few patients had both clinical and microarray data.|||||
707749|NCT00126555|Primary|Early Progression Rate|Number of participants out of total participants with progression following two 30 day courses of Gefitinib. Tumor response evaluated by Response Evaluation Criteria in Solid Tumors by physical exam, computed tomography (CT) or Magnetic Resonance Imaging (MRI). Progressive disease defined as determined as response to Gefitinib induction therapy: Progression: 25% increase in sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer). Participants restaged on days 15 and 60 of treatment.|Baseline to 60 days, up to 2 courses of induction therapy|||percentage of participants|||Number
707750|NCT00126568|Secondary|To Further Characterize the Safety Profile of BAY 43-9006 When Given to Patients With Advanced Anaplastic Carcinoma of the Thyroid.|The safety and toxicity profile of BAY 43-9006 as measured by toxicity grades of adverse events.|weekly||||||
707751|NCT00126568|Secondary|Overall Survival Was Measured From the Date of Outset of Treatment to the Date of Death.||27 months|All patients on study.||months||95% Confidence Interval|Median
707752|NCT00126568|Secondary|Progression Free Survival Was Measured From the Date of Outset of Treatment to the Date of Disease Progression.||27 months|All patients on study||months||95% Confidence Interval|Median
707753|NCT00126568|Primary|Number of Patients With Response to Treatment Measured by RECIST Criteria|Response evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. The patient's best response depends on the achievement of measurement and confirmation criteria of Complete Response (CR), Stable Disease (SD), Partial Response (PR) or Progressive Disease (PD). Measurable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques (CT, MRI, x-ray) or as >10 mm with spiral CT scan.|at 6 months after treatment|All patients that received at least one cycle of treatment||participants|||Number
707774|NCT00126737|Primary|Mental Scale SF-36v|The Rand Short Form-36 (SF-36) was used to measure health related quality of life (i.e. mental health). The average change in score 24 weeks post-baseline was measured. Mental Health component consisted of 4 scales; these are the scales: Vitality ( 4 items), Social functioning (2 items), Role Emotional (3 items), and Mental Health (5 items). The mental health summary measures is called the Mental health component of SF36v. It was used to measure health related quality of life (i.e. mental health). The total score ranged from 0 to 100, a score of 50 is the normative average for general mental health. Lower scores correspond to worse mental health status, higher scores correspond to better mental health status.|Between Base-line and 24 weeks|There are discrepancies in the numbers of participants being analyzed due to incomplete data collection. the disprepancies are in the following groups: 1 in Weight control Nutritional and home -based Exercise program, 3 in Weight Control Nutritional Program and 3 in Usual Care||Change in Score||95% Confidence Interval|Mean
707762|NCT00126594|Post-Hoc|Best Overall Response for Participants|Best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The participant's best response assignment will depend on the achievement of both measurement and confirmation criteria as defined by RECIST: Complete Response (CR): Disappearance all target lesions. Partial Response (PR): >30% decrease in sum of longest diameter (LD) of target lesions, reference baseline sum LD. Progressive Disease (PD): >20% increase in sum of LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum LD since treatment started. Radiologic testing for progressive disease repeated every 8 weeks.|From the date response is confirmed to the date of disease progression, first assessed 2 months (8 weeks) following start of treatment and reassessed up to 36 months (on average reassessed 12 months or less).|All participants were included per intent to treat analysis.||participants|||Number
707763|NCT00126594|Secondary|Duration of Response for Participants With Stable Disease (N=37) Following Treatment|Duration of response for participants with disease stabilization following treatment as measured from the date response is confirmed to the date of disease progression, first assessed up to 8 weeks (2 cycles) following start of treatment. The duration of a Stable Disease (SD) response is measured from the time measurement criteria are met for that specific SD response until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Repeat radiologic studies (CT, MRI, Chest x-ray and bone scan as indicated) to evaluate disease progression or response every 8 weeks.|From the date response is confirmed to the date of disease progression, up to 12 months|"Combined analysis reflects overall stable disease duration e.g. duration of benefit for stable disease cases without being affected by the median duration not attainable for the separate arms; 37 participants in the two arms met Stable Disease criteria: 17 in Sorafenib alone (Arm I) and 20 in the Sorafenib Plus Interferon group (Arm II)."||Months||95% Confidence Interval|Median
707764|NCT00126594|Secondary|Median Overall Survival (OS)|Overall survival defined as the time interval from the start of protocol therapy to death or date of last follow-up if alive.|From the start of protocol therapy to death or date of last follow-up, up to 36 months|Participants who die of unrelated cause during therapy or are lost to follow-up were censored. Median OS was not reached in Arm 1: Sorafenib as subjects experienced different events that made further follow-up impossible i.e. disease complications, death or lost to follow-up so overall survival data was not attainable.||Months||95% Confidence Interval|Median
707765|NCT00126594|Secondary|Progression-free Survival|Progression free survival (PFS) is defined as the time interval from the start of protocol therapy to death or disease progression.|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months|All participants were included per intent to treat analysis.||Months||95% Confidence Interval|Median
707766|NCT00126594|Secondary|Selected Grade 3-4 Adverse Events Using NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0|Adverse events graded using the CTCAE version 4.0 tabulated by treatment arm within either toxicity grade for the treatment period. Treatment-related toxicity (acute and cumulative) performed every 8 weeks during the first year.|Up to 12 months of treatment|All participants were included in adverse event reporting per intent to treat analysis.||participants|||Number
707767|NCT00126594|Primary|Objective Response Rate (ORR) Evaluated Using Response Evaluation Criteria in Solid Tumors (RECIST)|ORR defined as participants with Complete Response (CR) and Partial Response (PR) as defined by RECIST criteria: Complete Response (CR): Disappearance all target lesions. Partial Response (PR): >30% decrease in sum of longest diameter (LD) of target lesions, reference baseline sum LD. Progressive Disease (PD): >20% increase in sum of LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum LD since treatment started. Radiologic testing for progressive disease repeated every 8 weeks.|Tumor restaging performed at 8 weeks following baseline, responding or stable participants restaged at 8 week intervals, up to 12 months.|Analysis performed for the intent-to-treat population.||percentage of participants||95% Confidence Interval|Number
707768|NCT00126659|Secondary|Overall Survival|The number of participants surviving from baseline (treatment) to death due to any cause measured in days.|Up to 2 years||||||
707769|NCT00126659|Secondary|Duration of Overall Response|Duration of overall response is measured from the time measurement criteria are met for Complete Response or Partial Response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started), measured in days.|Following 10 weeks of treatment, followed every 2 weeks or until disease progression||||||
707770|NCT00126659|Secondary|Time to Progression|Time, in weeks, after treatment until disease progresses. Repeat radiologic studies to evaluate disease progression or response after 10 weeks of BAY 43 9006 therapy.|Following 10 weeks of treatment or until disease progression||||||
707771|NCT00126659|Primary|Efficacy of BAY 43-9006 by Evaluating Response Rate|"Response rate (participants with response/total number participants) where number of participants with response evaluated using international criteria proposed by (RECIST) Committee of: Complete Response: Disappearance all target lesions; Partial Response (PR): > 30% decrease in sum of longest diameter (LD) of target lesions, reference baseline sum LD. Progressive Disease (PD): > 20% increase in sum of LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of 1 or > new lesions; Stable Disease:
Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum LD since treatment started."|Every 2 weeks during 4 week cycle|Unable to assess response due to small sample size.|||||
707772|NCT00126737|Secondary|Stair Total (Climb, Descend)|Total amount of stairs climbed and descended for three minutes. Subjects climbed four steps up and descended four steps down. The average change in total number of steps 24 weeks post-baseline was measured.|Between Base-line and 24 Weeks|There are discrepancies in the numbers of participants being analyzed due to incomplete data collection. the disprepancies are in the following groups: 2 in Weight control Nutritional and home -based Exercise program, 1 in Weight Control Nutritional Program, 1 in Home-based exercise Program and 1 in Usual Care.||Change in Steps||95% Confidence Interval|Mean
707775|NCT00126737|Primary|Physical Scale SF-36v|The Rand Short Form-36 (SF-36) was used to measure health related quality of life (i.e. physical health). The average change in score 24 weeks post-baseline was measured. Physical Health consists of 4 scales, Physical Function (10 items), Role Physical (4 items), Bodily Pain (2 items), General Health (5 items). The Physical Health component is a summary measure of scales, and the scores ranges from 0 to 100, a score of 50 is the normative average of general health. Lower scores correspond to worse physical health, higher scores correspond to better physical health.|Between Base-line and 24 weeks|There are discrepancies in the numbers of participants being analyzed due to incomplete data collection. the disprepancies are in the following groups: 1 in Weight control Nutritional and home -based Exercise program, 3 in Weight Control Nutritional Program, 3 in the Usual Care.||Change in score||95% Confidence Interval|Mean
707776|NCT00126737|Primary|WOMAC Function|Western Ontario and McMaster University Osteoarthritis Index (WOMAC) is used to measure pain, function, and stiffness in patients with OA of the knee. At 24 weeks post-baseline, the average change in score was measured. We used the Function Scale only for this study. The Function Scale has 17 items, the responses are in Likert scale; namely 0=No difficulty, 1=Slight, 2=Moderate, 3= Very, 4=Extremely. The total score ranges from 0 to 68, a higher score means worse functioning. A score of 68 indicates extremely difficult in functioning.|Between Base-line and 24 weeks|There are discrepancies in the numbers of participants being analyzed due to incomplete data collection. the disprepancies are in the following groups: 2 in Weight control Nutritional and home -based Exercise program, 3 in Weight Control Nutritional Program, 1 in Home-based exercise program and 1 in Usual Care.||Change in Score||95% Confidence Interval|Mean
707777|NCT00126750|Primary|Primary Outcome Was the Performance of Each Provider on Each of Seven Clinical Indicators|The investigators used an intent-to-treat approach for our main analysis, basing our outcome measures on provider's eligible patient population in each of the clinics. Performance improvement was calculated at the change (before vs after the intervention) the percentage of provider's patients with each clinical indicator. 1) change in the percentage of patients with improvements in LDL. Improvement defined as LDL-C level < previous 18 mos; 2) Change in the percentage of patients with improvements in A1c. Improvement defined as HbA1c level < previous 18 mos; 3) Change in percentage of patients prescribed Beta Blockers; 4) Change in the percentage of patients prescribed Statins; 5) Change in the percentage of patients prescribed ACEI or ARB; 6) Change in percentage of patients reaching target goal for LDL-C (<100mg/dL); 7) Change in percentage of patients reaching target goal for HbA1c (<8%).|1/1/02 - 12/31/08|||percentage of provider's patients|||Number
707778|NCT00120042|Secondary|Endometrial Appearances Postpartum||3 years||||||
707779|NCT00120042|Secondary|Post-Delivery Blood Loss|Blood loss was assessed by weighing of pads and sheets in addition to clot|3 years|||mls||Inter-Quartile Range|Median
707780|NCT00120042|Primary|Placental Retention Rate|If spontaneous expulsion of the placenta within 60 minutes of fetal delivery did not occur, digital exploration of the uterus in the operating room was planned.|3 years|||participants|||Number
707781|NCT00120250|Secondary|Clinician-Administered PTSD Scale (CAPS)|"The CAPS is a highly detailed measure of the presence and severity of the DSM-IV PTSD criteria. The severity score was calculated by adding up the frequency score (scale 0 = none of the time to 4 = most or all of the time) and an intensity score (scale 0 = none to 4 = extreme), which can then be summed for all 17 symptom questions and/or for the three symptom clusters. Scores range from 0 to 136, where greater than or equal to 80 represents extreme PTSD symptomatology. In this case, the total score for all 17 symptom questions, which is also the sum of the three symptom clusters, is used."|Week 3|||units on a scale||Standard Deviation|Mean
707782|NCT00120250|Secondary|Total Sleep Time|Total Sleep Time was derived from a subject-completed daily sleep diary.|8 weeks|||Minutes||Standard Deviation|Mean
707783|NCT00120250|Secondary|Sleep Latency|Sleep Latency was derived from a subject-completed daily sleep diary.|8 weeks|||Minutes||Standard Deviation|Mean
707784|NCT00120250|Primary|Pittsburgh Sleep Quality Index (PSQI)|The PSQI is a 24-item, patient-administered scale that assess changes in sleep symptomatology. The total PSQI score ranges from 0 to 21 where a higher value indicates a worse sleep symptomatology.|8 weeks|||units on a scale||Standard Deviation|Mean
707785|NCT00120250|Primary|Short PTSD Rating Interview (SPRINT)|The SPRINT is a 8-item, clinician-administered scale assessing core and related symptoms of PTSD. Symptoms are rates on 5 point scales from 0 (not at all) to 4 (very much) where a higher value indicates a worse outcome.|8 weeks|||units on a scale||Standard Deviation|Mean
707786|NCT00120289|Secondary|Cardiovascular Mortality||Time to first event measured from date of randomization through last follow-up visit (common termination), for an average of 36 months follow-up, maximum 66 months.|Intention to treat||participants|||Number
707787|NCT00120289|Secondary|Composite Endpoint of CHD Death, Non-fatal MI, or Ischemic Stroke||Time to first event measured from date of randomization through last follow-up visit (common termination) for an average of 36 months follow-up, maximum 66 months|Intention to treat||participants|||Number
707788|NCT00120289|Secondary|Composite Endpoint of CHD Death, Non-fatal MI, High-risk ACS or Ischemic Stroke||Time to first event measured from date of randomization through last follow-up visit (common termination) for an average of 36 months follow-up, maximum 66 months|||participants|||Number
707789|NCT00120289|Primary|Composite End Point of CHD Death, Nonfatal MI, Ischemic Stroke, Hospitalization for Non-ST Segment Elevation Acute Coronary Syndrome (ACS), or Symptom-driven Coronary or Cerebral Revascularization||Time to first event measured from date of randomization through last follow-up visit (common termination) for an average of 36 months follow-up, maximum 66 months.|Intention-to-treat||participants|||Number
707790|NCT00120406|Primary|Primary Patency|Primary patency is defined as a Peak systolic velocity (PSV) ratio < 2.0 or angiographic percent diameter stenosis < 50%.|12 months|||Percentage of participants|Participants||Number
707791|NCT00120406|Primary|Event-free Survival Rate|"Event-free survival is defined as freedom from the major adverse events of death, target lesion revascularization, target limb ischemia requiring surgical intervention (bypass or amputation of toe, foot or leg), surgical repair of the target vessel (e.g., dissection requiring surgery), and from worsening of the Rutherford classification by 2 classes or to class 5 or 6.
Participant flow is based on initial randomization of Zilver PTX or PTA (Percutaneous balloon angioplasty), and Event-free survival is based on Per-Protocol analysis where only patients who were treated according to their initial randomization are counted."|12 months|||Percentage of participants|||Number
707793|NCT00120523|Primary|Potential Effect on the Developing Immune System|number (%) of patients with positive antibody titers to tetanus, hepatitis B, and measles vaccines at baseline, weeks 26 (6 months), 52 (1 year), 104 (2 years), 156 (3 years), 208 (4 years) and 260 (5 years) Varicella antibody titers were measured at the above time points in US patients only.|throughout the 5-year study|Immune system function data analyses were performed on the immunology set (774 patients). Varicella titers were assessed for USA patients only (n= 104, n=108).||% of patients with positive ab titer|||Number
707794|NCT00120523|Secondary|Vital Signs and Physical Examinations: Blood Pressure (BP)|Significant findings are included in the relevant medical history/current medical conditions (prior to study start) or in the AE documentation (after study start.|throughout the 5-year study|Safety/intent-to-treat (ITT) - all randomized patients who received at least one application of study medication.Patients who do not have baseline value are excluded from analysis.||mmHg||Standard Deviation|Mean
707795|NCT00120523|Secondary|Parent's Index of Quality of Life - Atopic Dermatitis (PIQoL-AD)|"PIQoL-AD questionnaire (28 questions) was only done in countries where validated questionnaire was available: Germany, Hungary, Netherlands, Spain, UK and US.
For the purposes of data presentation, a “Not True” response was coded a value of zero and a “True” a value of one. The total score (i.e., sum of individual questions) was calculated; lower the score, better the QoL. Minimum score = 0; maximum score = 28. If the patient has answered ≤14 questions at a time point, then the patient’s total score at the time point was set to missing."|throughout the 5-year study|Safety/intent-to-treat (ITT) - all randomized patients who received at least one application of study medication. Patients who do not have baseline value are excluded from the analysis.||units on a scale||Standard Deviation|Mean
707796|NCT00120523|Secondary|Body Surface Area Involved With Atopic Dermatitis|TBSA = Total body surface area; percent BSA affected = (BSA affected/TBSA) x 100.|throughout the 5-year study|Safety/intent-to-treat (ITT) - all randomized patients who received at least one application of study medication.||percentage of TBSA affected||Standard Deviation|Mean
707797|NCT00120523|Secondary|Investigator's Global Assessment (to Assess Disease Severity) of the Whole Body and of the Face: Treatment Success Rate|"IGA = Investigator's global Assessment. CI = Confidence interval for treatment success using binomial distribution: lower CI<0 is set to 0, upper CI>100 is set to 100.
Treatment success (n): IGA score of 0 or 1 (clear or almost clear). Outcome gives percentage of patients with treatment success."|throughout the 5-year study|Safety/intent-to-treat (ITT) - all randomized patients who received at least one application of study medication.||percentage of participants||95% Confidence Interval|Number
707798|NCT00120523|Primary|Growth Velocity (Weight)||throughout the 5-year study|Safety/intent-to-treat (ITT) - all randomized patients who received at least one application of study medication.Patient who do not have a baseline value are excluded from the analysis.||kg||Standard Deviation|Mean
707799|NCT00120523|Primary|Growth Velocity (Height)||throughout the 5-year study|Safety/intent-to-treat (ITT) – all randomized patients who received at least one application of study medication.Patient who do not have a baseline value are excluded from the analysis.||cm||Standard Deviation|Mean
707800|NCT00120523|Primary|Safety Assessed by Adverse Events|crude incidence of adverse events of primary interest and most frequent adverse events (greater than or equal to 5% crude incidence in either treatment group) in the treatment period|throughout the 5-year study|complete safety/ITT population of experimental and control||percentage of participants|||Number
707801|NCT00120627|Post-Hoc|Hyper-arousal (Criterion D) Subscale of CAPS From Diagnostic and Statistical Manual, 4th Ed., Text Revision|Hyper-arousal Subscale (Criterion D) assesses symptoms of difficulty falling or staying asleep, irritability or outbursts of anger, difficulty concentrating, hypervigilance, and exaggerated startle response. Items are rated by frequency on a scale of 0 (never) to 4 (daily or almost every day) and on intensity on a scale of 0 (none) to 4 (extreme, incapacitating distress). Scores are summed for a total subscale score ranging from 0 to 40, higher scores indicating greater levels of symptoms.|Pre-treatment to Post-treatment|||units on a scale||Standard Deviation|Mean
707802|NCT00120627|Post-Hoc|Avoidance (Criterion C) Subscale of the Clinician Administered PTSD Scale (CAPS) From Diagnostic and Statistical Manual, 4th Ed, Text Revision|Avoidance (Criterion C) Subscale assesses symptoms of feeling detached and estranged from others; markedly diminished interest in significant activities; efforts to avoid thoughts, feelings, or conversations associated with the trauma; and efforts to avoid activities, places, or people that arouse recollections of the trauma. Items are rated by frequency on a scale of 0 (never) to 4 (daily or almost every day) and on intensity on a scale of 0 (none) to 4 (extreme, incapacitating distress). Score are summed for a total subscale score ranging from 0 to 56, higher scores indicating greater levels of symptoms.|Pre-treatment and Post-treatment|||units on a scale||Standard Deviation|Mean
707803|NCT00120627|Post-Hoc|Re-experiencing (Criterion B) From the Clinician Administered PTSD Scale (CAPS) Clinician Administered PTSD Scale Defined by the Diagnostic and Statistical Manual, 4th Ed, Text Revision|Re-experiencing Subscale (Criterion B) assesses symptoms of persistent re-experiencing of the traumatic event. This may include recurrent, intrusive recollections of the traumatic event; recurring dreams of the event; acting or feeling as if the traumatic event were occuring; and intense psychological distress at exposure to internal or external cues that symbolize or represent the event. Items are rated by frequency on a scale of 0 (never) to 4 (daily or almost every day) and on intensity on a scale of 0 (none) to 4 (extreme, incapacitating distress). Score are summed for a total subscale score ranging from 0 to 40, higher scores indicating greater levels of symptoms.|Pre-treatment to Post-treatment|||units on a scale||Standard Deviation|Mean
707804|NCT00120627|Secondary|Brief Symptom Inventory 18 (BSI-18) With Subscales of Depression, Anxiety, and Somatization|The Brief Symptom Inventory 18 (BSI-18) is a self-report questionnaire with three subscales representing depressive symptoms, anxiety, and somatization. Each subscale consists of 6-items rated from 0=no symptoms to 4=great deal of symptoms. Scores for each subscale are summed and each subscale ranges from 0-24 with higher scores meaning worse symptoms.|Pre-treatment and Post-treatment|||units on a scale||Standard Deviation|Mean
707805|NCT00120627|Primary|PTST Checklist (PCL) Civilian Version|"The PTSD Checklist-Civilian is a 17 item self-report measure using a 5-point Likert scale to indicate how much one is bothered by the symptoms of PTSD from trauma. Items are rated from 0=not at all to 5=extremely. Higher scores indicate greater severity and scores range from 17-85."|Pre-treatment and Post-treatment|Intent to treat analysis using Expectation-Maximization (EM) algorithm in SPSS, a maximum-likelihood method based on group assignment, demographic variables and clinical variables.||units on a scale||Standard Deviation|Mean
707806|NCT00120627|Secondary|Quality of Life Enjoyment & Satisfaction Questionnaire (Q-LES-Q) General Activities|Quality of Life Enjoyment & Satisfaction Questionnaire general activities scale measures quality of life and satisfaction of 14 domains on a 1 (very poor) to 5 (very good) rating scale. Scores are summed and can range from 14 to 70 with higher scores indicating greater quality of life. Domains assessed represent physical health, mood, work/volunteer activity, household activity, social relationships, family relationships, leisure time activities, ability to function in daily life, sexual interest, economic status, living/housing situation, ability to get around physically without being unsafe, ability to do work or hobbies, and overall sense of wellbeing.|Pre- & Post-Intervention|Intent to treat analysis using Expectation-Maximization (EM) algorithm in SPSS to replace missing data, a maximum-likelihood method based on group assignment, demographic variables and clinical variables.||units on a scale||Standard Deviation|Mean
707807|NCT00120627|Secondary|Mindfulness Attention Awareness Scale (MAAS)|The Mindfulness Attention Awareness Scale (MAAS) is a 15-item questionnaire scored from 1 (almost always) to 6 (almost never) assessing individual differences in frequency of mindful states over time. Scores range from 15 to 90. Higher scores indicate greater mindful attention awareness. Mindfulness has been linked to well-being and quality of life. This questionnaire has documented content validity using factor analysis, evidence of convergent and discriminant validity, and test-retest reliability.|Baseline, Post-Intervention|||units on a scale||Standard Deviation|Mean
707808|NCT00120627|Secondary|Spiritual Well-being [Functional Assessment of Chronic Illness Therapy-Spiritual Wellbeing (FACIT-Sp)]|"FACIT-SP a measure of existential spiritual well-being. It contains 12 items that assess levels of feeling peaceful, having meaning and purpose in life and finding comfort in faith or spiritual beliefs. Items are rated on a 5-point Likert scale: 0 = not at all and 4 = very much. Scores can range from 0 to 48. Higher scores reflect greater levels of spiritual well-being."|Pre- & Post-Intervention|Intent to treat analysis using Expectation-Maximization (EM) algorithm in SPSS, a maximum-likelihood method based on group assignment, demographic variables and clinical variables.||units on a scale||Standard Deviation|Mean
707809|NCT00120627|Secondary|Short-Form (SF)-12v2 Health Quality of Life (Mental Health Component Score)|"Short-Form (SF)-12v2 measures health-related quality of life changes in mental and physical health function. The subscale SF12 Norm-Based Mental Component Summary Score rates mental health functioning. Items include feeling calm and peaceful, having alot of energy, feeling downhearted and blue -- all rated on a frequency scale from 1= all of the time to 6=none of the time. Other items ask if emotional problems such as feeling anxious or depressed interfere with (1) accomplishing less than you like and (2) not doing work or activies as carefully as usual (yes or no). Items are weighted and summed, and then converted to a 0 to 100 scale with higher scores indicating greater improvements."|Pre-treatment and post-treatment|Intent to treat analysis using Expectation-Maximization (EM) algorithm in SPSS to replace missing values; a maximum-likelihood method based on group assignment, demographic variables and clinical variables.||units on a scale||Standard Deviation|Mean
707810|NCT00120627|Primary|Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale (CAPS) From DSM-IVTR|"The Clinician Administered PTSD Scale (CAPS) is used to determine PTSD symptom severity and the presence or absence of a PTSD diagnosis. The total score is obtained by summing the frequency and intensity ratings for 17 items using a 5-point scale. Scores are summed and range from 0-136. The items for frequency are rated from 0=never to 4=daily or almost everyday. The items for intensity are rated from 0=none to 4=extreme. Higher scores indicate greater symptom severity. Total scores greater than 45 indicate the presence of a PTSD diagnosis.
The CAPS also has 3 subscales: 1) Criterion B (re-experiencing) has 5 items that are summed and scores range from 0 to 40; 2) Criterion C (avoidance) has 7 items that are summed and scores range from 0 to 56; and 3) Criterion D (hyper-arousal) has 5 items that are summed and scores range from 0 - 40. Higher scores indicate worse symptoms."|Pre-treatment and post-treatment|Intent to treat analysis using Expectation-Maximization (EM) algorithm in SPSS for missing data; this is a maximum-likelihood method based on group assignment, demographic variables and clinical variables.||units on a scale||Standard Deviation|Mean
707811|NCT00120874|Secondary|Change From Baseline of the Revised Memory and Behavior Problems Checklist (RMBPC): Caregiver Reaction|"The RMBPC is a 24 item rating scale of the frequency of memory and behavioral problems in the AD subject and of how upset or bothered their caregivers react. Frequency is rated from 0 (least frequent) to 4 (most frequent) and caregiver reaction is rated from 0 (not at all) to 4 (extremely bothered or upset). Higher scores indicate more frequent memory and behavioral problems in the subject with AD as well as a more upset or bothered caregiver. Possible scores range from 0 to 96."|Baseline to 52 weeks|||units on a scale||Standard Deviation|Mean
707812|NCT00120874|Secondary|Change From Baseline of the Revised Memory and Behavior Problems Checklist (RMBPC): Frequency|"The RMBPC is a 24 item rating scale of the frequency of memory and behavioral problems in the AD subject and of how upset or bothered their caregivers react. Frequency is rated from 0 (least frequent) to 4 (most frequent) and caregiver reaction is rated from 0 (not at all) to 4 (extremely bothered or upset). Higher scores indicate more frequent memory and behavioral problems in the subject with AD as well as a more upset or bothered caregiver. Possible scores range from 0 to 96."|Baseline to 52 weeks|||units on a scale||Standard Deviation|Mean
707813|NCT00120874|Secondary|Change From Baseline of the Revised Memory and Behavior Problems Checklist (RMBPC): Caregiver Reaction|"The RMBPC is a 24 item rating scale of the frequency of memory and behavioral problems in the AD subject and of how upset or bothered their caregivers react. Frequency is rated from 0 (least frequent) to 4 (most frequent) and caregiver reaction is rated from 0 (not at all) to 4 (extremely bothered or upset). Higher scores indicate more frequent memory and behavioral problems in the subject with AD as well as a more upset or bothered caregiver. Possible scores range from 0 to 96."|Baseline to 28 weeks|||units on a scale||Standard Deviation|Mean
707814|NCT00120874|Secondary|Change From Baseline of the Revised Memory and Behavior Problems Checklist (RMBPC): Frequency|"The RMBPC is a 24 item rating scale of the frequency of memory and behavioral problems in the AD subject and of how upset or bothered their caregivers react. Frequency is rated from 0 (least frequent) to 4 (most frequent) and caregiver reaction is rated from 0 (not at all) to 4 (extremely bothered or upset). Higher scores indicate more frequent memory and behavioral problems in the subject with AD as well as a more upset or bothered caregiver. Possible scores range from 0 to 96."|Baseline to 28 weeks|||units on a scale||Standard Deviation|Mean
714106|NCT00229957|Secondary|Falls and Injuries|self-reported number of falls in last 6 months|baseline, 15 months||08/2009||||
707815|NCT00120874|Secondary|Change From Baseline of The Behavioral Pathology in Alzheimer's Disease Frequency Weighted Severity Scale (BEHAVE-AD-FW)|The BEHAVE-AD-FW measures the frequency and severity of 25 behavioral symptoms with a total score and global rating. Individual behavioral assessments are rated for severity (0=none to 3-most severe) and frequency (1=least frequent to 4=most frequent) which are then multiplied; scores for each of the 25 items are then summed. Possible total scores range from 0 to 297. The global rating is scored from 0 (not dangerous to patient, not troubling to caregiver) to 3 (dangerous to patient, highly troubling to caregiver). The higher the score the worse the outcome.|Baseline to 52 weeks|||units on a scale||Standard Deviation|Mean
707816|NCT00120874|Secondary|Change From Baseline of The Behavioral Pathology in Alzheimer's Disease Frequency Weighted Severity Scale (BEHAVE-AD-FW)|The BEHAVE-AD-FW measures the frequency and severity of 25 behavioral symptoms with a total score and global rating. Individual behavioral assessments are rated for severity (0=none to 3-most severe) and frequency (1=least frequent to 4=most frequent) which are then multiplied; scores for each of the 25 items are then summed. Possible total scores range from 0 to 297. The global rating is scored from 0 (not dangerous to patient, not troubling to caregiver) to 3 (dangerous to patient, highly troubling to caregiver). Global rating was not analyzed for this study. The higher the score the worse the outcome.|Baseline to 28 weeks|||units on a scale||Standard Deviation|Mean
707817|NCT00120874|Secondary|Change From Baseline of the Functional Assessment Staging Disability Score (FAST-DS)|"The FAST-DS assesses the magnitude of progressive functional deterioration by identifying characteristic progressive disabilities in participants with AD. Scores range from 1.0 (normal) to 7f (severe loss of ability, not even able to hold up head independently). Scores are made up of stages (1 through 7) and substages (from a to e for stage 6; from a to f for stage 7). The following scoring for substages is applied: 6a=6.0, 6b=6.2, 6c=6.4, 6d=6.6, 6e=6.8, 7a=7.0, 7b=7.2, 7c=7.4, 7d=7.6, 7e=7.8, 7f=8.0. Additionally, non-consecutive deficits are noted and scored as follows: full stage non-consecutive deficit=1.0, non-consecutive substage deficit=0.2.
The overall FAST-DS score = (FAST Stage Score) + (Each Non-Consecutive FAST disability scored as described)"|Baseline to 52 weeks|||units on a scale||Standard Deviation|Mean
707818|NCT00120874|Primary|Change From Baseline of The Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory Modified for Severe Dementia Abbreviated Version (ADCS-ADLsev-abv)|The ADCS-ADLsev-abv is a structured questionnaire where each item consists of a series of hierarchical questions designed to determine a patient's ability to perform the activities of daily living as assessed by the caregiver. Possible scores range from 0 to 39, where a higher score is indicative of greater capacities.|Baseline to 52 weeks|||units on a scale||Standard Deviation|Mean
707819|NCT00120874|Primary|Change From Baseline of The Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory Modified for Severe Dementia Abbreviated Version (ADCS-ADLsev-abv)|The ADCS-ADLsev-abv is a structured questionnaire where each item consists of a series of hierarchical questions designed to determine a patient's ability to perform the activities of daily living as assessed by the caregiver. Possible scores range from 0 to 39, where a higher score is indicative of greater capacities.|Baseline to 28 weeks|||units on a scale||Standard Deviation|Mean
707820|NCT00120874|Secondary|Change From Baseline of the Functional Assessment Staging Disability Score (FAST-DS)|"The FAST-DS assesses the magnitude of progressive functional deterioration by identifying characteristic progressive disabilities in participants with AD. Scores range from 1.0 (normal) to 7f (severe loss of ability, not even able to hold up head independently). Scores are made up of stages (1 through 7) and substages (from a to e for stage 6; from a to f for stage 7). The following scoring for substages is applied: 6a=6.0, 6b=6.2, 6c=6.4, 6d=6.6, 6e=6.8, 7a=7.0, 7b=7.2, 7c=7.4, 7d=7.6, 7e=7.8, 7f=8.0. Additionally, non-consecutive deficits are noted and scored as follows: full stage non-consecutive deficit=1.0, non-consecutive substage deficit=0.2.
The overall FAST-DS score = (FAST Stage Score) + (Each Non-Consecutive FAST disability scored as described)"|Baseline to 28 weeks|||units on a scale||Standard Deviation|Mean
707821|NCT00120874|Secondary|Change From Baseline of the Mini-Mental State Examination (MMSE)|The MMSE is a graded on a 30 point scale that measures cognitive functioning. A lower score indicates a higher level of impairment. Complete scale range is -no cognitive impairment=24-30; mild cognitive impairment=18-23; severe cognitive impairment=0-17.|Baseline to 52 weeks|||units on a scale||Standard Deviation|Mean
707822|NCT00120874|Secondary|Change From Baseline of the Mini-Mental State Examination (MMSE)|The MMSE is a graded on a 30 point scale that measures cognitive functioning. A lower score indicates a higher level of impairment. Complete scale range is -no cognitive impairment=24-30; mild cognitive impairment=18-23; severe cognitive impairment=0-17.|Baseline to 28 weeks|||units on a scale||Standard Deviation|Mean
707823|NCT00120874|Secondary|Change From Baseline of the Severe Impairment Battery (SIB)|The SIB evaluates cognitive performance. It is a 51 item scale which assesses social interaction, memory, language, orientation, attention, praxis, visuospacial ability and construction. Scores range from 0 (greatest impairment) to 100 (least impairment).|Baseline to 52 weeks|||units on a scale||Standard Deviation|Mean
707824|NCT00120874|Secondary|Change From Baseline of the Severe Impairment Battery (SIB)|The SIB evaluates cognitive performance. It is a 51 item scale which assesses social interaction, memory, language, orientation, attention, praxis, visuospacial ability and construction. Scores range from 0 (greatest impairment) to 100 (least impairment).|Baseline to 28 weeks|||units on a scale||Standard Deviation|Mean
707825|NCT00120874|Primary|Change From Baseline in Clinician Interview-Based Assessment of Change Plus Caregiver Input (CIBIC-Plus) Global Score (New York Univeristy Version)|CIBIC-Plus is measured in units on a scale ranging from 1 to 7, where 1 is markedly improved, 4 is unchanged, and 7 is markedly worse|Baseline to 52 weeks|||units on a scale||Standard Deviation|Mean
707826|NCT00120874|Primary|Change From Baseline in Clinician Interview-Based Assessment of Change Plus Caregiver Input (CIBIC-Plus) Global Score (New York Univeristy Version)|CIBIC-Plus is measured in units on a scale ranging from 1 to 7, where 1 is markedly improved, 4 is unchanged, and 7 is markedly worse|Baseline to 28 weeks|||units on a scale||Standard Deviation|Mean
707827|NCT00126776|Primary|Hospitalization or ED Visit for COPD (Mean Cumulative Frequency)||1 yr|||events per year||95% Confidence Interval|Mean
707828|NCT00126776|Secondary|All Cause Mortality||1 year||||||
707829|NCT00126776|Secondary|COPD Exacerbations Requiring Antibiotics or Corticosteroids||1 year||||||
707830|NCT00126776|Secondary|Quality of Life||1 year||||||
707831|NCT00126776|Secondary|All Cause Hospitalizations||1 year||||||
707835|NCT00127036|Primary|Number of Participants Per Treatment Arm, Per Tumor Tissue Response Classifier|Investigators would develop tumor tissue classifiers to predict response to the XELOX arm or XELIRI arm; with gene expression profiles on 75 patients on each of 2 arms, construct 2 classifiers to distinguish responders (complete responses, partial responses, stable disease) from non-responders (progressive disease).|30 Days After End of Treatment - Average of 6 Months|Low accrual and early termination prevented us from performing the planned analysis. Too few patients had both clinical and microarray data.|||||
707836|NCT00127101|Secondary|Number of Participants Who Responded to Treatment|"Disease burden as assessed by the pre-specified Severity Weighted Assessment Tool (SWAT) measurement. A Response is defined as equal to or greater than 50% improvement in SWAT score.
SWAT Score is determined by the Lesions classified as patch, plaque, or tumor. The sum of percent of total body surface area (%TBSA) by lesion type is derived and multiplied by a factor of 1 (for patch), 2 (for plaque), or 4 (for tumor). The skin score total is derived by summing the skin score subtotals for patches, plaques and tumors. The skin score total is dimensionless and can range from 0 to 400"|Every 28 days for up to 6 Months of Treatment|All patients treated||Participants|||Number
707837|NCT00127101|Primary|Maximum Tolerated Dose (MTD) as Determined by the Number of Participants With Dose Limiting Toxicities|Number of patients with Dose Limiting Toxicities (DLT). A DLT is an adverse event that determined the treatment dose level was not tolerable for that patient in Cycle 1.|Day 1 to day 28|All Patients treated||Participants|||Number
707838|NCT00127166|Secondary|Average (Avg) %-Change in FEV1 After First Beta (β)-Agonist Use and Prior to Second β-agonist Use|The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on the extent and severity of EIB as measured by the average percent change in FEV1 after first β-agonist intake and prior to second β-agonist use.|4 weeks (Weeks 0 to 4 or Weeks 6 to 10)|The secondary efficacy analysis was based on the FAS population which included all randomized participants who took at least one dose of post randomization study drug and had a measurement for analysis available in both treatment periods of the cross-over design.||Percent change from baseline||95% Confidence Interval|Least Squares Mean
707839|NCT00127166|Secondary|Time to Recovery to Within 5% of Baseline FEV1|The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on the extent and severity of EIB as measured by the time to recovery (to within 5 percent of the pre-exercise baseline FEV1) following a standardized exercise challenge.|4 weeks (Weeks 0 to 4 or Weeks 6 to 10)|The secondary efficacy analysis was based on the FAS population which included all randomized participants who took at least one dose of post randomization study drug and had a measurement for analysis available in both treatment periods of the cross-over design.||minutes||Inter-Quartile Range|Median
707840|NCT00127166|Secondary|Maximum FEV1 % Predicted Following First Beta-agonist Use|The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on short-acting β-agonist bronchodilation as measured by the maximum FEV1 percent predicted following first β-agonist use.|4 weeks (Weeks 0 to 4 or Weeks 6 to 10)|The secondary efficacy analysis was based on the FAS population which included all randomized participants who took at least one dose of post randomization study drug and had a measurement for analysis available in both treatment periods of the cross-over design.||Percent of predicted value||95% Confidence Interval|Least Squares Mean
707841|NCT00127166|Secondary|Area Under the Curve for %-Change From Pre-exercise Baseline FEV1 in Liters (L), From 0 to 20 Minutes (AUC(0-20))|The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on the extent and severity of EIB as measured by the area under the curve from 0 to 20 minutes (AUC0-20) for FEV1 percent change from pre-exercise baseline.|4 weeks (Weeks 0 to 4 or Weeks 6 to 10)|The secondary efficacy analysis was based on the FAS population which included all randomized participants who took at least one dose of post randomization study drug and had a measurement for analysis available in both treatment periods of the cross-over design.||Percent times Minutes||95% Confidence Interval|Least Squares Mean
707842|NCT00127166|Primary|Maximum Post-exercise Percent (%) Fall in FEV1|The effect of four weeks of treatment with oral montelukast plus inhaled fluticasone, and inhaled salmeterol plus inhaled fluticasone on EIB as measured by the maximum post-exercise percent fall (relative to pre-exercise baseline) in FEV1.|4 weeks (Weeks 0 to 4 or Weeks 6 to 10)|The primary efficacy analysis was based on the full analysis set (FAS) population which included all randomized participants who took at least one dose of post randomization study drug and had a measurement for analysis available in both treatment periods of the cross-over design.||Percent change from baseline||95% Confidence Interval|Least Squares Mean
707843|NCT00127192|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 12|Change from baseline at Week 12 is defined as Week 12 minus Week 0.|Baseline and Week 12|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. For FAS patients with no data at Week 12, the last non-baseline observed measurement was carried forward to Week 12.||mg/dL||95% Confidence Interval|Least Squares Mean
707844|NCT00127192|Primary|Change From Baseline in HbA1c at Week 12|HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the Week 0 HbA1c percent.|Baseline and Week 12|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. For FAS patients with no data at Week 12, the last non-baseline observed measurement was carried forward to Week 12.||Percent||95% Confidence Interval|Least Squares Mean
707845|NCT00127192|Secondary|Change From Baseline in Glycosylated Albumin at Week 12|Change from baseline at Week 12 is defined as Week 12 minus Week 0.|Baseline and Week 12|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. For FAS patients with no data at Week 12, the last non-baseline observed measurement was carried forward to Week 12.||Percent||95% Confidence Interval|Least Squares Mean
707846|NCT00127218|Secondary|Time to Multiple Combined Events ( Cardiovascular and Cerebrovascular Events, Myocardial Revascularization as Well as All Cause and Cardiovascular Death)||18 months||||||
707847|NCT00127218|Primary|Changes in Plaque Architecture and Composition Directly Measured by Magnetic Resonance Imaging (MRI) in the Aorta and Carotid Arteries|The primary endpoint is Changes in plaque architecture and composition directly measured by magnetic resonance imaging (MRI) in the aorta and carotid arteries.|18 months|||percentage of internal carotid artery||Standard Error|Mean
707848|NCT00127413|Primary|Clinician Administered Assessment of PTSD|This 30-item structured interview is designed to assess both the 17 symptoms of PTSD and the 8 hypothesized associated features. The scale yields a dichotomous diagnosis of PTSD, and also provides a continuous score of frequency and severity for each symptom. In addition, a behaviorally anchored probe question is provided for each symptom to increase the reliability of administration. The CAPS has excellent sensitivity (.81) and specificity (.95) (Newman, Kaloupek, & Keane, 1996). For the purpose of these analyses we examined the total CAPS score. Total CAPS scores can range from 0 to 136. Higher scores represent poorer outcome with a score of greater than 50 indicating that a person meets criteria for PTSD.|Pretreatment (baseline), Posttreatment (3 months), and 6 month Follow-up|||units on a scale||Standard Deviation|Mean
707849|NCT00127530|Secondary|Lower Extremity Manual Muscle Test; Ashworth Score for Spasticity||Days 14, 42, 70, 98||||||
707850|NCT00127530|Primary|Timed Walk Responders (Patients Who Showed Consistent Improvement on the Timed-25 Foot Walk)|Patients who showed a faster walking speed for at least three of the four on-drug visits during the double-blind treatment period as compared to the maximum speed for any of the five off-drug visits.|Days 14, 42, 70 and 98 of treatment, corresponding to the four on-drug visits during double-blind treatment period.|ITT Population||Participants|||Number
707851|NCT00127660|Primary|Energy Intake|energy content of meal ordered and consumed.|After meal|||kcal/meal||Standard Deviation|Mean
707852|NCT00127660|Primary|Total Calories of Meal Ordered||single study visit||||||
707853|NCT00127712|Secondary|Length of Hospital Stay||Duration of hospitalization|||Days||Full Range|Median
707854|NCT00127712|Primary|Incidence of Atrial Fibrillation Lasting Longer Than 30 Seconds||7 days|||Participants|||Number
707855|NCT00127712|Secondary|Length of Intensive Care Unit Stay||Duration of hospitalization|||Hours||Full Range|Median
707856|NCT00127712|Primary|Incidence of Atrial Fibrillation Requiring Treatment||7 days|||participants|||Number
707857|NCT00127790|Secondary|Depression Severity|Total score from the 20-item Center for Epidemiologic Studies Depression Scale-revised where the total score ranges from 0-60 and higher scores indicate greater depression severity.|Pre to Post Treatment Chnage (Over an average of approximately 10 weeks)|participants who completed intervention and pre and post treatment assessments||units on a scale||Standard Error|Mean
707858|NCT00127790|Primary|IL-6|Circulating levels of Interleukin-6 (IL-6)from plasma drawn in the morning. Values are presented as picograms per milliliter (pg/mL) and can range from 0 to 500, though tend to be in the range of 0-10. Higher values indicate higher amounts of circulating levels of IL-6, a marker of increased inflammatory processes.|Pre to Post Treatment Change (Over an average of approximately 10 weeks)|Subjects completing blood draws to obtain plasma. One subject in the CBT-I&P condition did not complete blood draws.||pg/mL||Standard Error|Mean
707859|NCT00127790|Primary|Pain Severity|Multidimensional Pain Inventory - Pain Severity SubScale score. The subscale consists of 3 items with a total subscale score ranging from 0-18 with higher values indicating greater pain severity.|Pre to Post Treatment Change (Over an average of approximately 10 weeks)|||units on a scale||Standard Error|Mean
707860|NCT00127790|Primary|Insomnia Severity|Total Score from the 7-item Insomnia Severity Index where total score ranges from 0-28 and higher scores indicate greater severity of insomnia.|Pre to Post Treatment Change (Over an average of approximately 10 weeks)|completed the intervention and self report instruments||units on a scale||Standard Error|Mean
707861|NCT00127803|Primary|Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With Either One of Three Formulations of the Clostridium Difficile Vaccine or a Placebo Vaccine.||Day 0 to up to 70 days post-first vaccination|Safety assessments were on the safety population.||Participants|||Number
707862|NCT00127803|Primary|Number of Participants Reporting Solicited Injection Site Erythema and Tenderness Post-vaccination With Either One of Three Formulations of Clostridium Difficile Vaccines or a Placebo Vaccine.||Day 0 and up to 7 days post each vaccination|Safety assessments were on the safety population.||Participants|||Number
707863|NCT00127803|Secondary|Number of Participants With Seroconversion for Toxin A and Toxin B Post-vaccination With Either One of Three Formulations of the Clostridium Difficile Vaccine or a Placebo Vaccine.|"Seroconversion was defined as a ≥4-fold increase in antibody levels from Baseline. For values below the limit of quantification (LLQ) for the assay, the LLQ was used.
Serum anti-toxin IgG levels were determined by enzyme linked immunosorbent assay (ELISA)."|Days 28, 56, 70, and 236 Post First Vaccination|Serum anti-toxin levels were assessed in the Fully Evaluable (Per-Protocol) Population.||Participants|||Number
707864|NCT00127842|Secondary|Percentage of Participants With a Psoriatic Arthritis Response Criteria (PsARC) Response at Month 24|Psoriatic Arthritis Response Criteria response is defined as improvement from Baseline in at least 2 of 4 criteria, one of which must be joint pain /tenderness or swelling and no worsening in any of the 4 following criteria: • Joint Pain/Tenderness score: Physician assessment of 78 joints for pain/tenderness on a scale from 0 (none) to 3 (severe) with a total score ranging from 0 to 234, with higher scores indicating more severe disability; • Joint Swelling score: Physician assessment of 78 joints for swelling on a scale from 0 (none) to 3 (severe) with a total score ranging from 0 to 234 with higher scores indicating more severe disability; • Patient global assessment of disease activity: Measured on a 5-point scale from 1 (very good) to 5 (very poor); • Physician global assessment of disease activity: Measured on a 5-point scale from 1 (very good) to 5 (very poor).|Baseline and Month 24|Full Analysis Set, composed of all participants who received at least one dose of study medication and had at least one baseline and at least one post-baseline measurement for the endpoint of interest. Imputation by last observation carried forward (LOCF) was applied.||percentage of participants||95% Confidence Interval|Number
707865|NCT00127842|Secondary|Percentage of Participants With Improvement of ≥ 75 Percent From Baseline to Month 24 in the Psoriasis Activity and Severity Index (PASI)|The PASI was is a method for quantifying the intensity of psoriasis, and for evaluating its improvement with treatment. This index is based on the quantitative assessment of three typical signs of psoriatic lesions: erythema, infiltration, and desquamation, combined with the skin surface area involvement. The index has a range from 0.0 to 72.0, with higher scores indicating worse psoriasis.|Baseline and Month 24|Full Analysis Set, composed of all participants who received at least one dose of study medication and had at least one baseline and at least one post-baseline measurement for the endpoint of interest. Imputation by last observation carried forward (LOCF) was applied.||percentage of participants||95% Confidence Interval|Number
707866|NCT00127842|Secondary|Percent Change From Baseline to Month 24 in Patient Global Assessment|The patient global assessment of disease activity is a 5-point scale that asks how the participant is doing since their last visit with regard to their rheumatoid arthritis. Participants answer on a scale from 1 (very good, asymptomatic, no limitation in normal activites) to 5 (very poor, very severe symptoms that are intolerable, inability to perform all normal activites). Percent change from Baseline was calculated as (Baseline value - Month 24 value) / Baseline value * 100. A positive change from Baseline indicates improvement.|Baseline and month 24|Full Analysis Set, composed of all participants who received at least one dose of study medication and had at least one baseline and at least one post-baseline measurement for the endpoint of interest. Imputation by last observation carried forward (LOCF) was applied. Change was based on paired data.||Percentage change||Full Range|Mean
707867|NCT00127842|Secondary|Change From Baseline to Month 24 in Patient Global Assessment|The patient global assessment of disease activity is a 5-point scale that asks how the participant is doing since their last visit with regard to their rheumatoid arthritis. Participants answer on a scale from 1 (very good, asymptomatic, no limitation in normal activites) to 5 (very poor, very severe symptoms that are intolerable, inability to perform all normal activites). Change from Baseline was calculated as Baseline value - Month 24 value. A positive change from Baseline indicates improvement.|Baseline and Month 24|Full Analysis Set, composed of all participants who received at least one dose of study medication and had at least one baseline and at least one post-baseline measurement for the endpoint of interest. Imputation by last observation carried forward (LOCF) was applied.||Units on a scale||Standard Deviation|Mean
707868|NCT00127842|Secondary|Percent Change From Baseline to Month 24 in Physician Global Assessment|"The physician global assessment of disease activity asks the physician to assess how the participant is doing since their last visit on a scale from 1 (very good, asymptomatic, no limitations in normal activities) to 5 (very poor, severe symptoms that are intolerable, inability to carry out all normal activites).
Percent change from Baseline was calculated as (Baseline value - Month 24 value) / Baseline value * 100. A positive change from Baseline indicates improvement."|Baseline and Month 24|Full Analysis Set, composed of all participants who received at least one dose of study medication and had at least one baseline and at least one post-baseline measurement for the endpoint of interest. Imputation by last observation carried forward (LOCF) was applied.||Percentage change||Full Range|Mean
707869|NCT00127842|Secondary|Change From Baseline to Month 24 in the Physician Global Assessment|The physician global assessment of disease activity asks the physician to assess how the participant is doing since their last visit on a scale from 1 (very good, asymptomatic, no limitations in normal activities) to 5 (very poor, severe symptoms that are intolerable, inability to carry out all normal activites). Change from Baseline was calculated as Baseline value - Month 24 value. A positive change from Baseline indicates improvement.|Baseline and month 24|Full Analysis Set, composed of all participants who received at least one dose of study medication and had at least one baseline and at least one post-baseline measurement for the endpoint of interest. Imputation by last observation carried forward (LOCF) was applied.||Units on a scale||Standard Deviation|Mean
707870|NCT00127842|Secondary|Change From Baseline to Month 24 in the HLQ Impediments to Paid and Unpaid Labour Module|"In the HLQ impediments to paid and unpaid labor module participants were asked Were you hindered by health problems at your paid work over the past two weeks? and answered according to the following: 'no not at all = 0', ‘yes, a little = 1’, ‘yes, very = 2’. Participants were also asked whether they had performed 4 unpaid activities (household work, shopping, odd jobs / chores, and childcare), and answered according to the following: Did do, hindered = 1; Did do, not hindered = 0; Did not do, due to health problems = 2; Did not do, due to other reasons = 0. The aggregated score ranges from 0 (no impediments) to 8 (unable to do any of the surveyed activities). Change from Baseline was calculated as the Baseline value - Month 24 value. A positive change from Baseline value indicates improvement."|Baseline and month 24|Full Analysis Set participants who completed the HLQ at Baseline and Month 24 and who performed any unpaid work at both time points.||Units on a scale||Standard Deviation|Mean
707871|NCT00127842|Secondary|Change From Baseline to Month 24 in the HLQ Unpaid Labour Production Module|The HLQ collects quantitative data on the relation between illness and treatment and work performance. The instrument is divided into 4 modules to collect data about absence from work, reduced productivity at paid work, unpaid labor production and impediments to paid and unpaid labor. The Unpaid Labour Production Module assesses the amount of hours of unpaid work (including household work, shopping, caring for children and odd jobs around the house), normally performed by the participant, that were taken over by other members of the household, family or friends (unpaid help), and/or by paid workers due to health problems of the participant. Change from Baseline was calculated as the Baseline value - Month 24 value. A positive change from Baseline value indicates improvement.|Baseline and month 24|"Full Analysis Set participants who completed the HLQ at Baseline and Month 24 and who performed any unpaid work at both time points (71 participants). n indicates the number of participants who had unpaid or paid help with their unpaid work."||Hours||Standard Deviation|Mean
707872|NCT00127842|Secondary|Change From Baseline to Month 24 in the HLQ Reduced Productivity at Paid Work Module|"The HLQ collects quantitative data on the relation between illness and treatment and work performance. The instrument is divided into 4 modules to collect data about absence from work, reduced productivity at paid work, unpaid labor production and impediments to paid and unpaid labor. In the reduced productivity at work module participants were asked to estimate the number of additional hours required to compensate for production losses due to illness on working days over the past 2 weeks.
Change from Baseline was calculated as the Baseline value - Month 24 value. A positive change from Baseline value indicates improvement."|Baseline and Month 24|Full Analysis Set participants who completed the HLQ at Baseline and Month 24, were employed, and indicated they had some production losses due to health problems at work (participants with no production losses were not included).||Hours||Standard Deviation|Mean
707884|NCT00127855|Secondary|Number of Subjects Seroprotected for Anti-poliovirus Types 1, 2 and 3 Antibodies|Seroprotection is defined as anti-polio antibody titer greater than or equal to 1:8 dilution.|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for safety, including all vaccinated subjects who had not received a vaccine not specified or forbidden in the protocol, for the Month 10 data.||Subjects|||Number
707873|NCT00127842|Secondary|Change From Baseline to Month 24 in the Health and Labour Questionnaire (HLQ) Absence From Work Module|The HLQ collects quantitative data on the relation between illness and treatment and work performance. The instrument is divided into 4 modules to collect data about absence from work, reduced productivity at paid work, unpaid labor production and impediments to paid and unpaid labor. The absence from work module asks participants to indicate how many days in the past 2 weeks they missed work due to health problems. Change from Baseline was calculated as the Baseline value - Month 24 value. A positive change from Baseline value indicates improvement.|Baseline and 24 months|Full Analysis Set participants who completed the HLQ at Baseline and Month 24, and were employed.||days||Standard Deviation|Mean
707874|NCT00127842|Primary|Percentage of Participants With Improvement of ≥ 0.50 Units From Baseline to Month 24 in the HAQ DI|The HAQ DI is a questionnaire which measures functional status in patients with psoriatic arthritis. The questionnaire addresses health-related quality of life issues related to psoriatic arthritis such as dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability.|Baseline and 24 months|Full Analysis Set, composed of all participants who received at least one dose of study medication and had at least one baseline and at least one post-baseline measurement for the endpoint of interest. Imputation by last observation carried forward (LOCF) was applied.||percentage of participants||95% Confidence Interval|Number
707875|NCT00127855|Secondary|Number of Subjects Reporting Serious Adverse Events After Administration of the Polysaccharide Challenge Dose|Serious adverse events cover all medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Up to one month following administration of the polysaccharide challenge dose (Month 11)|The analysis was performed on the Booster Total Vaccinated Cohort.||Subjects|||Number
707876|NCT00127855|Secondary|Number of Subjects Reporting Serious Adverse Events During the Primary Vaccination Course|Serious adverse events cover all medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Up to one month after the 3-dose primary vaccination course (Month 5)|The analysis was performed on the Total Vaccinated Cohort.||Subjects|||Number
707877|NCT00127855|Secondary|Number of Subjects Reporting Unsolicited Adverse Events After Administration of the Polysaccharide Challenge Dose|Unsolicited adverse event covers any adverse event reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31-Day (Day 0-30) follow-up period after administration of the polysaccharide challenge dose|The analysis was performed on the Booster Total Vaccinated Cohort.||Subjects|||Number
707878|NCT00127855|Secondary|Number of Subjects Reporting Unsolicited Adverse Events During the Primary Vaccination Course|Unsolicited adverse event covers any adverse event reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31-Day (Day 0-30) follow-up period after any vaccine dose during the primary vaccination course|The analysis was performed on the Total Vaccinated Cohort.||Subjects|||Number
707879|NCT00127855|Secondary|Number of Subjects Reporting Solicited Local and General Symptoms After Administration of the Polysaccharide Challenge Dose|Solicited local symptoms assessed include pain, redness and swelling at the injection site. Solicited general symptoms assessed include drowsiness, irritability, loss of appetite and fever (rectal temperature greater than or equal to 38 degrees Celcius).|During the 8-Day (Day 0-7) follow-up period after the polysaccharide challenge dose|The analysis was performed on the Booster Total Vaccinated Cohort, on subjects having completed the symptom sheet.||Subjects|||Number
707880|NCT00127855|Secondary|Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Course|Solicited local symptoms assessed include pain, redness and swelling at the injection site. Solicited general symptoms assessed include drowsiness, irritability, loss of appetite and fever (rectal temperature greater than or equal to 38 degrees Celcius).|During the 8-Day (Day 0-7) follow-up period after any vaccine dose during the primary vaccination course|The analysis was performed on the Total Vaccinated Cohort, on subjects having completed the symptom sheet.||Subjects|||Number
707881|NCT00127855|Secondary|Anti-pneumococcal Antibody Concentrations|Pneumococcal antibodies assessed included anti-4, anti-6B, anti-9V, anti-14, anti-18C, anti-19F and anti-23F antibodies. Concentrations are presented as GMCs and expressed as micrograms per milliliter (µg/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10 data.||Micrograms per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
707882|NCT00127855|Secondary|Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values|Pneumococcal antibodies assessed included anti-4, anti-6B, anti-9V, anti-14, anti-18C, anti-19F and anti-23F antibodies. The cut-off values assessed were 0.05 and 0.2 micrograms per milliliter (µg/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for safety, including all vaccinated subjects who had not received a vaccine not specified or forbidden in the protocol, for the Month 10 data.||Subjects|||Number
707883|NCT00127855|Secondary|Anti-poliovirus Types 1, 2 and 3 Antibody Titers|Titers are presented as GMTs and expressed in terms of the 50 % inhibitory dilution.|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10 data.||Titer||95% Confidence Interval|Geometric Mean
714107|NCT00229957|Secondary|Functional Limitations|Late Life Function and Disability Instrument: A measure of functional limitations and disability in older adults.|baseline, 15 months||08/2009||||
707885|NCT00127855|Secondary|Anti- HBs Antibody Concentrations|Concentrations are presented as GMCs and expressed as Milli-International Units per Milliliter (mIU/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10 data.||Milli-International Units per Milliliter||95% Confidence Interval|Geometric Mean
707886|NCT00127855|Secondary|Number of Subjects Seroprotected for Anti-hepatitis B (HBs) Antibodies|Seroprotection is defined as anti-HBs antibody concentration greater than or equal to 10 Milli-International Units per Milliliter (mIU/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for safety, including all vaccinated subjects who had not received a vaccine not specified or forbidden in the protocol, for the Month 10 data.||Subjects|||Number
707887|NCT00127855|Secondary|Anti- PT Antibody Concentrations|Concentrations are presented as GMCs and expressed as Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10 data.||ELISA Units per Milliliter (EL.U/mL)||95% Confidence Interval|Geometric Mean
707888|NCT00127855|Secondary|Number of Subjects Seroseropositive for Anti-pertussis Toxoid (PT) Antibodies|Seropositivity is defined as anti-PT antibody concentration greater than or equal to 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for safety, including all vaccinated subjects who had not received a vaccine not specified or forbidden in the protocol, for the Month 10 data.||Subjects|||Number
707889|NCT00127855|Secondary|Anti-PRN Antibody Concentrations|Concentrations are presented as GMCs and expressed as Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10 data.||ELISA Units per Milliliter (EL.U/mL)||95% Confidence Interval|Geometric Mean
707890|NCT00127855|Secondary|Number of Subjects Seroseropositive for Anti-pertactin (PRN) Antibodies|Seropositivity is defined as anti-PRN antibody concentration greater than or equal to 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for safety, including all vaccinated subjects who had not received a vaccine not specified or forbidden in the protocol, for the Month 10 data.||Subjects|||Number
707891|NCT00127855|Secondary|Anti- FHA Antibody Concentrations|Concentrations are presented as GMCs and expressed as Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10 data.||ELISA Units per Milliliter (EL.U/mL)||95% Confidence Interval|Geometric Mean
707892|NCT00127855|Secondary|Number of Subjects Seroseropositive for Anti-filamentus Haemagglutinin (FHA) Antibodies|Seropositivity is defined as anti-FHA antibody concentration greater than or equal to 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for safety, including all vaccinated subjects who had not received a vaccine not specified or forbidden in the protocol, for the Month 10 data.||Subjects|||Number
707893|NCT00127855|Secondary|Anti-tetanus Antibody Concentrations|Concentrations are presented as GMCs and expressed as International Units per Milliliter (IU/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for safety, including all vaccinated subjects who had not received a vaccine not specified or forbidden in the protocol, for the Month 10 data.||International Units per Milliliter||95% Confidence Interval|Geometric Mean
707894|NCT00127855|Secondary|Number of Subjects Seroprotected for Anti-tetanus Antibodies|Seroprotection is defined as anti-tetanus toxoid antibody concentration greater than or equal to 0.1 International Units per Milliliter (IU/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for safety, including all vaccinated subjects who had not received a vaccine not specified or forbidden in the protocol, for the Month 10 data.||Subjects|||Number
707895|NCT00127855|Secondary|Anti-diphtheria Antibody Concentrations|Concentrations are presented as GMCs and expressed as International Units per Milliliter (IU/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for safety, including all vaccinated subjects who had not received a vaccine not specified or forbidden in the protocol, for the Month 10 data.||International Units per Milliliter||95% Confidence Interval|Geometric Mean
707896|NCT00127855|Secondary|Number of Subjects Seroprotected for Anti-diphtheria Antibodies|Seroprotection is defined as anti-diphtheria toxoid antibody concentration greater than or equal to 0.1 International Units per Milliliter (IU/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for safety, including all vaccinated subjects who had not received a vaccine not specified or forbidden in the protocol, for the Month 10 data.||Subjects|||Number
707897|NCT00127855|Secondary|Anti-PRP Antibody Concentration|Concentrations are presented as GMCs and expressed as µg/mL.|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.||Microgram per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
707898|NCT00127855|Secondary|Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values|The cut-off concentrations assessed were 0.15 micrograms per milliliter (µg/mL) and 1 µg/mL.|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.||Subjects|||Number
707899|NCT00127855|Secondary|Anti-polysaccharide Y (PSY) Antibody Concentration|Titers are presented as Geometric Mean Titers (GMTs) expressed as micrograms per milliliter (µg/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.||Microgram per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
707900|NCT00127855|Secondary|Number of Subjects With Anti-polysaccharide Y (PSY) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)|The cut-off concentration assessed was 30 micrograms per milliliter (µg/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.||Subjects|||Number
707901|NCT00127855|Secondary|Anti-polysaccharide C (PSC) Antibody Concentration|Titers are presented as Geometric Mean Titers (GMTs) expressed as micrograms per milliliter (µg/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.||microgram per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
707902|NCT00127855|Secondary|Number of Subjects With Anti-polysaccharide C (PSC) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)|The cut-off concentration assessed was 30 micrograms per milliliter (µg/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.||Subjects|||Number
707903|NCT00127855|Secondary|Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup Y (MenY) Titers|Titers were presented as geometric mean titers (GMTs) expressed as the reciprocal of the dilution resulting in 50 percent inhibition.|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.||Titer||95% Confidence Interval|Geometric Mean
707904|NCT00127855|Secondary|Number of Subjects With rSBA-MenY Titers Greater Than or Equal to 1:8|The cut-off titer assessed was a dilution of 1:8. Titers were expressed as the reciprocal of the dilution resulting in 50 percent inhibition.|Prior to vaccination (Day 0), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.||Subjects|||Number
707905|NCT00127855|Secondary|Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers|Titers were presented as geometric mean titers (GMTs) expressed as the reciprocal of the dilution resulting in 50 percent inhibition.|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.||Titer||95% Confidence Interval|Geometric Mean
707919|NCT00128180|Secondary|Number of Participants Intubated and Placed on a Ventilator After Study Entry.|Participants|6 months|This efficacy this analysis was limited to participants with confirmed hantavirus infection who were not already intubated at study entry.||participants|||Number
707920|NCT00128180|Secondary|Duration of Shock and/or Pressor/Inotropic Support|Pressor/inotropic support refers to the use of adrenaline-like medications to maintain blood pressure and cardiac output.|6 months|Per protocol, efficacy analysis was limited to participants with confirmed hantavirus infection.||days||Standard Deviation|Mean
707906|NCT00127855|Secondary|Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers Greater Than or Equal to 1:8|The cut-off titer assessed was a dilution of 1:8. Titers were expressed as the reciprocal of the dilution resulting in 50 percent inhibition.|Prior to vaccination (Day 0), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.||Subjects|||Number
707907|NCT00127855|Primary|Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup Y (MenY) Titers Greater Than or Equal to 1:8|The cut-off titer assessed was a dilution of 1:8. Titers were expressed as the reciprocal of the dilution resulting in 50 percent inhibition.|One month after primary vaccination (Month 5)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample during the primary vaccination course.||Subjects|||Number
707908|NCT00127855|Primary|Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers Greater Than or Equal to 1:8|The cut-off titer assessed was a dilution of 1:8. Titers were expressed as the reciprocal of the dilution resulting in 50 percent inhibition.|One month after primary vaccination (Month 5)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample during the primary vaccination course.||Subjects|||Number
707909|NCT00127855|Primary|Number of Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to 1 Milligram Per Milliliter|The cut-off concentration assessed was 1 milligram per milliliter (mg/mL).|One month after primary vaccination (Month 5)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample during the primary vaccination course.||Subjects|||Number
707910|NCT00127933|Secondary|Participants With Overall Survival|Overall survival was defined as the time from date of start of study treatment to the date of death, regardless of the cause of death. Patients who were alive at the time of the analysis were censored at the date of the last follow-up assessment. Patients without follow-up assessment were censored at the day of the last dose. Patients with no post-baseline information were censored at the start of study treatment.|22 - 1191 days|The analysis was done on the post-operative Response Evaluable Population.||participants|||Number
707911|NCT00127933|Secondary|Participants With Disease-Free Survival|Disease-free survival was defined as the time from date of surgery to date of first evidence of cancer recurrence in the breast (ie, local or distant recurrence or contra lateral disease) or death from any cause, whichever came first. Patients who were alive or withdrawn from the study and had no evidence of disease recurrence and for whom there was CRF evidence that evaluations had been made were censored at the date of the last clinical follow-up assessment when the patient was known to be disease free.|30 - 1102 days|The analysis was done on the Postoperative Response Evaluable Population.||participants|||Number
707912|NCT00127933|Secondary|Percentage of Participants With Local Recurrence|Local recurrence was defined as evidence of recurrent carcinoma in the same breast where it was diagnosed initially before preoperative treatment.|30 - 1102 days|Postoperative Response Evaluable Population||percentage of participants||95% Confidence Interval|Number
707913|NCT00127933|Secondary|Percentage of Participants With Overall Clinical Response (Complete Response (CR) Plus Partial Response (PR))|The best overall response in an individual patient, according to RECIST, during preoperative treatment was the best response recorded from the start of study treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the baseline assessment) or completion of preoperative treatment. Patients with CR or PR were considered responders. Patients with no tumor assessment after the start of study treatment were considered nonresponders.|post 2 and 4, 3-week cycles of treatment|Evaluable Population||percentage of participants||95% Confidence Interval|Number
707914|NCT00127933|Secondary|Percentage of Participants With Complete Pathological Response in the Primary Breast Tumor at the Time of Definitive Surgery|Pathological complete response was defined as the absence of histological evidence of invasive breast cancer cells in the tissue specimen removed from the breast after 4 cycles of preoperative treatment.|at the time of definitive surgery; after four 3-week cycles (3-4 months)|Pathological Response Evaluable Population||percentage of participants||95% Confidence Interval|Number
707915|NCT00127933|Primary|Percentage of Participants Assessed for Pathological Complete Response (pCR) Plus Near Complete (npCR) in Primary Breast Tumor at Time of Definitive Surgery|Pathological complete response was defined as the absence of histological evidence of invasive breast cancer cells in the tissue specimen removed from the breast after 4 cycles of preoperative treatment. Near pCR (npCR) was defined as the presence of invasive tumor cells with a size of 5 mm or less in aggregate in the tissue specimen removed from the breast after 4 cycles of preoperative treatment. Only pathological assessments occurring prior to the first date of adjuvant treatment were included in the analysis of pCR rate.|at the time of definitive surgery; after four 3-week cycles (3-4 months)|Pathological Response Evaluable Population||percentage of participants||95% Confidence Interval|Number
707916|NCT00128180|Secondary|Development of Serum Creatinine Greater Than or Equal to 3.0 mg/dL After Study Entry||6 months|Per protocol, this efficay analysis was limited to participants with confirmed hantavirus infection who did not have a serum creatinine equal or greater to 3.0 mg/dL at entry.||participants|||Number
707917|NCT00128180|Secondary|Length of Time on a Ventilator||6 months|Per protocol this efficacy analysis was limited to participants with confirmed hantavirus infection who were intubated and on a ventillator.||days||Standard Deviation|Mean
707918|NCT00128180|Secondary|Number of Participants Who Developed Refractory Shock Despite Fluid Resuscitation After Study Entry|Refractory shock refers to shock that persists despite fluid resucitation. Fluid resusitation refers to administration of intravenous fluids to maintain blood pressure and cardiac output.|6 months|Per protocol, this efficacy analysis was limited to participants with confirmed hantavirus infection who were not already in shock at study entry.||participants|||Number
707925|NCT00128180|Primary|The Proportion of Subjects Who Develop Death, PaO2/FiO2 Ratio Less Than or Equal to 55, Cardiac Index Less Than or Equal to 2.2, Pulseless Electrical Activity, Ventricular Tachycardia or Fibrillation||28 days|Per protocol, the efficacy analysis was limited to participants with confirmed hantavirus infection.||proportion of paticipants|||Number
707926|NCT00128193|Primary|Number of Participants Positive for Phenolic Glycolipid-1 (PGL-1) by QuantiFERON Results and the Presence or Absence of Induration at the Injection Site for the Antigen PPD|Blood was collected at Day 0 prior to antigen administration for the assessment of PGL-1 and QuantiFERON. The mutually exclusive categories present the number of participants positive or negative by the two assays based on presence of induration at any of the follow up visit assessments. Results for PGL-1 of weakly, moderately or strongly positive are grouped as positive. A result greater than 0 is considered positive for QuantiFERON. A fifth category is listed to report the number of participants who were missing either assay result or the induration assessment.|Day 0 for PGL-1 and QuantiFERON; Days 3, 7, and 28 for induration|All evaluable participants in Group C1 and C1b who received the antigen are included in the analysis population.||Participants|||Number
707927|NCT00128193|Primary|Number of Participants Positive for Phenolic Glycolipid-1 (PGL-1) by QuantiFERON Results and the Presence or Absence of Induration at the Injection Site for the Antigen MLCwA at Doses of 1.0 Microgram|Blood was collected at Day 0 prior to antigen administration for the assessment of PGL-1 and QuantiFERON. The mutually exclusive categories present the number of participants positive or negative by the two assays based on presence of induration at any of the follow up visit assessments. Results for PGL-1 of weakly, moderately or strongly positive are grouped as positive. A result greater than 0 is considered positive for QuantiFERON. A fifth category is listed to report the number of participants who were missing either assay result or the induration assessment.|Day 0 for PGL-1 and QuantiFERON; Days 3, 7, and 28 for induration|All participants in Group C1 who received the antigen are included in the analysis population.||Participants|||Number
707928|NCT00128193|Primary|Number of Participants Positive for Phenolic Glycolipid-1 (PGL-1) by QuantiFERON Results and the Presence or Absence of Induration at the Injection Site for the Antigen MLCwA at Doses of 0.1 Microgram|Blood was collected at Day 0 prior to antigen administration for the assessment of PGL-1 and QuantiFERON. The mutually exclusive categories present the number of participants positive or negative by the two assays based on presence of induration at any of the follow up visit assessments. Results for PGL-1 of weakly, moderately or strongly positive are grouped as positive. A result greater than 0 is considered positive for QuantiFERON. A fifth category is listed to report the number of participants who were missing either assay result or the induration assessment.|Day 0 for PGL-1 and QuantiFERON; Days 3, 7, and 28 for induration|All evaluable participants in Group C1b who received the antigen are included in the analysis population.||Participants|||Number
707929|NCT00128193|Primary|Number of Participants Positive for Phenolic Glycolipid-1 (PGL-1) by QuantiFERON Results and the Presence or Absence of Induration at the Injection Site for the Antigen MLSA-LAM at Doses of 1.0 Microgram|Blood was collected at Day 0 prior to antigen administration for the assessment of PGL-1 and QuantiFERON. The mutually exclusive categories present the number of participants positive or negative by the two assays based on presence of induration at any of the follow up visit assessments. Results for PGL-1 of weakly, moderately or strongly positive are grouped as positive. A result greater than 0 is considered positive for QuantiFERON. A fifth category is listed to report the number of participants who were missing either assay result or the induration assessment.|Day 0 for PGL-1 and QuantiFERON; Days 3, 7, and 28 for induration|All participants in Group C1 who received the antigen are included in the analysis population.||Participants|||Number
707930|NCT00128193|Primary|Number of Participants Positive for Phenolic Glycolipid-1 (PGL-1) by QuantiFERON Results and the Presence or Absence of Induration at the Injection Site for the Antigen MLSA-LAM at Doses of 0.1 Microgram|Blood was collected at Day 0 prior to antigen administration for the assessment of PGL-1 and QuantiFERON. The mutually exclusive categories present the number of participants positive or negative by the two assays based on presence of induration at any of the follow up visit assessments. Results for PGL-1 of weakly, moderately or strongly positive are grouped as positive. A result greater than 0 is considered positive for QuantiFERON. A fifth category is listed to report the number of participants who were missing either assay result or the induration assessment.|Day 0 for PGL-1 and QuantiFERON; Days 3, 7, and 28 for induration|All evaluable participants in Group C1b who received the antigen are included in the analysis population.||Participants|||Number
707931|NCT00128193|Primary|Number of Participants With QuantiFERON Responses Based on the Presence or Absence of Induration at the Injection Site for the Antigen PPD.|Blood collection for the QuantiFERON assessment was at Day 0 prior to antigen administration. Participants are considered to have a positive QuantiFERON response if the result was greater than 0. The categories present the number of participants who are positive or negative by QuantiFERON based on whether or not induration was assessed as present at any of the follow up visit assessments. A fifth category is listed to report the number of participants who were missing either a QuantiFERON result or induration assessment. The categories are mutually exclusive.|Day 0 for QuantiFERON; Days 3, 7, and 28 for induration|All evaluable participants in Groups C1 and C1b who received the antigen are included in the analysis population.||Participants|||Number
707932|NCT00128193|Primary|Number of Participants With QuantiFERON Responses Based on the Presence or Absence of Induration at the Injection Site for the Antigen MLCwA at Doses of 1.0 Microgram.|Blood collection for the QuantiFERON assessment was at Day 0 prior to antigen administration. Participants are considered to have a positive QuantiFERON response if the result was greater than 0. The categories present the number of participants who are positive or negative by QuantiFERON based on whether or not induration was assessed as present at any of the follow up visit assessments. A fifth category is listed to report the number of participants who were missing either a QuantiFERON result or induration assessment. The categories are mutually exclusive.|Day 0 for QuantiFERON; Days 3, 7, and 28 for induration|All participants in Group C1 who received the antigen are included in the analysis population.||Participants|||Number
707945|NCT00128193|Primary|Mean Diameter of Induration at Site of Injection With the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 1.0 Micrograms|If induration was present, it was measured in millimeters at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups).|Day 7|The analysis population is restricted to participants in Groups B1 and C1 who had measurable induration at the time of assessment.||Millimeters||Standard Deviation|Mean
707933|NCT00128193|Primary|Number of Participants With QuantiFERON Responses Based on the Presence or Absence of Induration at the Injection Site for the Antigen MLCwA at Doses of 0.1 Microgram.|Blood collection for the QuantiFERON assessment was at Day 0 prior to antigen administration. Participants are considered to have a positive QuantiFERON response if the result was greater than 0. The categories present the number of participants who are positive or negative by QuantiFERON based on whether or not induration was assessed as present at any of the follow up visit assessments. A fifth category is listed to report the number of participants who were missing either a QuantiFERON result or induration assessment. The categories are mutually exclusive.|Day 0 for QuantiFERON; Days 3, 7, and 28 for induration|All evaluable participants in Group C1b who received the antigen are included in the analysis population.||Participants|||Number
707934|NCT00128193|Primary|Number of Participants With QuantiFERON Responses Based on the Presence or Absence of Induration at the Injection Site for the Antigen MLSA-LAM at Doses of 1.0 Microgram.|Blood collection for the QuantiFERON assessment was at Day 0 prior to antigen administration. Participants are considered to have a positive QuantiFERON response if the result was greater than 0. The categories present the number of participants who are positive or negative by QuantiFERON based on whether or not induration was assessed as present at any of the follow up visit assessments. A fifth category is listed to report the number of participants who were missing either a QuantiFERON result or induration assessment. The categories are mutually exclusive.|Day 0 for QuantiFERON; Days 3, 7, and 28 for induration|All participants in Group C1 who received the antigen are included in the analysis population.||Participants|||Number
707935|NCT00128193|Primary|Number of Participants With QuantiFERON Responses Based on the Presence or Absence of Induration at the Injection Site for the Antigen MLSA-LAM at Doses of 0.1 Microgram.|Blood collection for the QuantiFERON assessment was at Day 0 prior to antigen administration. Participants are considered to have a positive QuantiFERON response if the result was greater than 0. The categories present the number of participants who are positive or negative by QuantiFERON based on whether or not induration was assessed as present at any of the follow up visit assessments. A fifth category is listed to report the number of participants who were missing either a QuantiFERON result or induration assessment. The categories are mutually exclusive.|Day 0 for QuantiFERON; Days 3, 7, and 28 for induration|All evaluable participants in Group C1b who received the antigen are included in the analysis population.||Participants|||Number
707936|NCT00128193|Primary|Mean Diameter of Induration at Site of Injection With the Antigen Purified Protein Derivative (PPD)|If induration was present, it was measured in millimeters at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups).|Day 28|The analysis population is restricted to participants in all groups who had measurable induration at the time of assessment.||Millimeters||Standard Deviation|Mean
707937|NCT00128193|Primary|Mean Diameter of Induration at Site of Injection With the Antigen Purified Protein Derivative (PPD)|If induration was present, it was measured in millimeters at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups).|Day 7|The analysis population is restricted to participants in Groups B1, B2, C1 and C1b who had measurable induration at the time of assessment.||Millimeters||Standard Deviation|Mean
707938|NCT00128193|Primary|Mean Diameter of Induration at Site of Injection With the Antigen Purified Protein Derivative (PPD)|If induration was present, it was measured in millimeters at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups).|Day 3|The analysis population is restricted to participants in all groups who had measurable induration at the time of assessment.||Millimeters||Standard Deviation|Mean
707939|NCT00128193|Primary|Mean Diameter of Induration at Site of Injection With the Antigen Purified Protein Derivative (PPD)|If induration was present, it was measured in millimeters at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups).|Day 2|The analysis population is restricted to participants in Groups A1 and A2 who had measurable induration at the time of assessment.||Millimeters||Standard Deviation|Mean
707940|NCT00128193|Primary|Mean Diameter of Induration at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Micrograms|If induration was present, it was measured in millimeters at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups).|Day 7|The analysis population is restricted to participants in Groups B2 and C1 who had measurable induration at the time of assessment.||Millimeters||Standard Deviation|Mean
707941|NCT00128193|Primary|Mean Diameter of Induration at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Micrograms|If induration was present, it was measured in millimeters at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups).|Day 3|The analysis population is restricted to participants in Groups A2, B2 and C1 who had measurable induration at the time of assessment.||Millimeters||Standard Deviation|Mean
707942|NCT00128193|Primary|Mean Diameter of Induration at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Micrograms|If induration was present, it was measured in millimeters at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups).|Day 2|The analysis population is restricted to participants in Group A2 who had measurable induration at the time of assessment.||Millimeters||Standard Deviation|Mean
707943|NCT00128193|Primary|Mean Diameter of Induration at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 0.1 Micrograms|If induration was present, it was measured in millimeters at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups).|Day 7|The analysis population is restricted to participants in Groups B2 and C1b who had measurable induration at the time of assessment.||Millimeters||Standard Deviation|Mean
707944|NCT00128193|Primary|Mean Diameter of Induration at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 0.1 Micrograms|If induration was present, it was measured in millimeters at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups).|Day 3|The analysis population is restricted to participants in Groups A2, B2 and C1b who had measurable induration at the time of assessment.||Millimeters||Standard Deviation|Mean
708607|NCT00138151|Primary|Response Rate (Complete and Partial)|All patients who receive at least 3 courses of protocol therapy will be considered evaluable for response of measurable disease.|8 years|Study was closed prematurely due to slow accrual and lack of study drug. Insufficient accrual to evaluate response rate.|||||
707946|NCT00128193|Primary|Mean Diameter of Induration at Site of Injection With the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 1.0 Micrograms|If induration was present, it was measured in millimeters at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups).|Day 3|The analysis population is restricted to participants in Groups A1, B1 and C1 who had measurable induration at the time of assessment.||Millimeters||Standard Deviation|Mean
707947|NCT00128193|Primary|Mean Diameter of Induration at Site of Injection With the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 1.0 Micrograms|If induration was present, it was measured in millimeters at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups).|Day 2|The analysis population is restricted to participants in Group A1 who had measurable induration at the time of assessment.||Millimeters||Standard Deviation|Mean
707948|NCT00128193|Primary|Mean Diameter of Induration at Site of Injection With the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 0.1 Micrograms|If induration was present, it was measured in millimeters at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups).|Day 7|The analysis population is restricted to participants in Groups B1 and C1b who had measurable induration at the time of assessment.||Millimeters||Standard Deviation|Mean
707949|NCT00128193|Primary|Mean Diameter of Induration at Site of Injection With the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 0.1 Micrograms|If induration was present, it was measured in millimeters at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups).|Day 3|The analysis population is restricted to participants who had measurable induration at the time of assessment.||Millimeters||Standard Deviation|Mean
707950|NCT00128193|Primary|Mean Diameter of Erythema at Site of Injection With the Antigen Purified Protein Derivative (PPD)|If erythema was present, it was measured in millimeters for participants in Groups C1 and C1b only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present.|Day 7|The analysis population is restricted to participants in Group C1 and C1b who had measurable erythema at the time of assessment.||Millimeters||Standard Deviation|Mean
707951|NCT00128193|Primary|Mean Diameter of Erythema at Site of Injection With the Antigen Purified Protein Derivative (PPD)|If erythema was present, it was measured in millimeters for participants in Groups C1 and C1b only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present.|Day 3|The analysis population is restricted to participants in Group C1 and C1b who had measurable erythema at the time of assessment.||Millimeters||Standard Deviation|Mean
707952|NCT00128193|Primary|Mean Diameter of Erythema at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Micrograms|If erythema was present, it was measured in millimeters for participants in Groups C1 and C1b only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present.|Day 7|The analysis population is restricted to participants in Group C1 who had measurable erythema at the time of assessment.||Millimeters||Standard Deviation|Mean
707953|NCT00128193|Primary|Mean Diameter of Erythema at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Micrograms|If erythema was present, it was measured in millimeters for participants in Groups C1 and C1b only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present.|Day 3|The analysis population is restricted to participants in Group C1 who had measurable erythema at the time of assessment.||Millimeters||Standard Deviation|Mean
707954|NCT00128193|Primary|Mean Diameter of Erythema at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 0.1 Micrograms|If erythema was present, it was measured in millimeters for participants in Groups C1 and C1b only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present.|Day 7|The analysis population is restricted to participants in Group C1b who had measurable erythema at the time of assessment.||Millimeters||Standard Deviation|Mean
707955|NCT00128193|Primary|Mean Diameter of Erythema at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 0.1 Micrograms|If erythema was present, it was measured in millimeters for participants in Groups C1 and C1b only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present.|Day 3|The analysis population is restricted to participants in Group C1b who had measurable erythema at the time of assessment.||Millimeters||Standard Deviation|Mean
707956|NCT00128193|Primary|Mean Diameter of Erythema at Site of Injection With the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 1.0 Micrograms|If erythema was present, it was measured in millimeters for participants in Groups C1 and C1b only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present.|Day 7|The analysis population is restricted to participants in Group C1 who had measurable erythema at the time of assessment.||Millimeters||Standard Deviation|Mean
707957|NCT00128193|Primary|Mean Diameter of Erythema at Site of Injection With the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 1.0 Micrograms|If erythema was present, it was measured in millimeters for participants in Groups C1 and C1b only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present.|Day 3|The analysis population is restricted to participants in Group C1 who had measurable erythema at the time of assessment.||Millimeters||Standard Deviation|Mean
707958|NCT00128193|Primary|Mean Diameter of Erythema at Site of Injection With the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 0.1 Micrograms|If erythema was present, it was measured in millimeters for participants in Groups C1 and C1b only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present.|Day 7|The analysis population is restricted to participants in Group C1b who had measurable erythema at the time of assessment.||Millimeters||Standard Deviation|Mean
707959|NCT00128193|Primary|Mean Diameter of Erythema at Site of Injection With the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 0.1 Micrograms|If erythema was present, it was measured in millimeters for participants in Groups C1 and C1b only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present.|Day 3|The analysis population is restricted to participants in Group C1b who had measurable erythema at the time of assessment.||Millimeters||Standard Deviation|Mean
708608|NCT00138203|Secondary|Toxicity||From first dose of treatment until 30 days from the last dose of treatment||||||
707960|NCT00128193|Primary|Number of Participants With the Reaction of Itching to the Antigen Purified Protein Derivative (PPD)|Itching was assessed for participants in Groups B and C only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present. Itching was reported as present or absent, and not graded for severity.|Up to 28 Days|All participants in Groups B and C who received the antigen are included in the analysis population.||Participants|||Number
707961|NCT00128193|Primary|Number of Participants With Reactions to the Antigen Purified Protein Derivative (PPD)|Participants returned to the clinic at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups), for reader measurements of erythema and induration and assessment of other adverse events of pain/tenderness, bleeding, urticaria, infection, or blistering/ulcerating. Participants are counted if they had any measurable eythema or induration, or reported any of the other listed adverse events. Reactions were reported as present or absent, and were not graded for severity.|Up to 28 Days|All participants who received the antigen are included in the analysis population.||Participants|||Number
707962|NCT00128193|Primary|Number of Participants With the Reaction of Itching to the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Microgram|Itching was assessed for participants in Groups B and C only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present. Itching was reported as present or absent, and not graded for severity.|Up to 28 Days|All participants in Groups B and C who received the antigen are included in the analysis population.||Participants|||Number
707963|NCT00128193|Primary|Number of Participants With Reactions to the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Microgram|Participants returned to the clinic at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups), for reader measurements of erythema and induration and assessment of other adverse events of pain/tenderness, bleeding, urticaria, infection, or blistering/ulcerating. Participants are counted if they had any measurable eythema or induration, or reported any of the other listed adverse events. Reactions were reported as present or absent, and were not graded for severity.|Up to 28 Days|All participants who received the antigen are included in the analysis population.||Participants|||Number
707964|NCT00128193|Primary|Number of Participants With Reaction of Itching to the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 0.1 Microgram|Itching was assessed for participants in Groups B and C only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present. Itching was reported as present or absent, and not graded for severity.|Up to 28 Days|||Participants|||Number
707965|NCT00128193|Primary|Number of Participants With Reactions to the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 0.1 Microgram|Participants returned to the clinic at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups), for reader measurements of erythema and induration and assessment of other adverse events of pain/tenderness, bleeding, urticaria, infection, or blistering/ulcerating. Participants are counted if they had any measurable eythema or induration, or reported any of the other listed adverse events. Reactions were reported as present or absent, and were not graded for severity.|Up to 28 Days|All participants who received the antigen are included in the analysis population.||Participants|||Number
707966|NCT00128193|Primary|Number of Participants With the Reaction of Itching to the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 1.0 Microgram|Itching was assessed for participants in Groups B and C only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present. Itching was reported as present or absent, and not graded for severity.|Up to 28 Days|All participants in Groups B and C who received the antigen are included in the analysis population.||Participants|||Number
707967|NCT00128193|Primary|Number of Participants With Reactions to the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 1.0 Microgram|Participants returned to the clinic at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups), for reader measurements of erythema and induration and assessment of other adverse events of pain/tenderness, bleeding, urticaria, infection, or blistering/ulcerating. Participants are counted if they had any measurable eythema or induration, or reported any of the other listed adverse events. Reactions were reported as present or absent, and were not graded for severity.|Up to 28 Days|All participants who received the antigen are included in the analysis population.||Participants|||Number
707968|NCT00128193|Primary|Number of Participants With the Reaction of Itching to the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 0.1 Microgram|Itching was assessed for participants in Groups B and C only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present. Itching was reported as present or absent, and not graded for severity.|Up to 28 Days|All participants in Groups B and C who received the antigen are included in the analysis population.||Participants|||Number
707969|NCT00128193|Primary|Number of Participants With Reactions to the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 0.1 Microgram|Participants returned to the clinic at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups), for reader measurements of erythema and induration and assessment of other adverse events of pain/tenderness, bleeding, urticaria, infection, or blistering/ulcerating. Participants are counted if they had any measurable erythema or induration, or reported any of the other listed adverse events. Reactions were reported as present or absent, and were not graded for severity.|Up to 28 Days|All participants who received the antigen are included in the analysis population.||Participants|||Number
707970|NCT00128206|Secondary|Cost Effectiveness||course of treatment||||||
707971|NCT00128206|Secondary|Completion of Therapy||course of treatment||||||
707972|NCT00128206|Primary|Number of Participants With Laboratory Test or Clinical Judgment Resulting in the Need to Stop Study Medication|Liver function tests were taken at regular intervals and clinical symptoms were reviewed at regular intervals in both study groups. On the basis of these tests and examinations, physicians determined whether the study drug needed to be stopped.|up to one year|The number of participants was determined by power calculations using estimates of toxicity from the literature. The analysis was intention to treat.||participants|||Number
708609|NCT00138203|Secondary|Overall Survial|Overall survial of subjects from the start of treatment to the time of death|From treatment start to time of death|All subjects who were considered evaulable (received more than one treatment cycle) were included in this evaluation||months||Full Range|Median
707973|NCT00128219|Secondary|The Density of Type III GBS Cultured From Vaginal Swabs at Month 18|The density of type III GBS is an ordinal response with six Density Levels: negative (lowest density, Score 0); broth only (Score 1); 1+ (Score 2); 2+ (Score 3); 3+ (Score 4); and 4+ (highest density, Score 5). The number of swabs with each score was tabulated from swabs collected at Month 18. Density at missed visits prior to loss to follow-up/final visit was imputed from the subsequent visit.|Month 18|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||Swabs|||Number
707974|NCT00128219|Secondary|The Density of Type III GBS Cultured From Vaginal Swabs at Month 16|The density of type III GBS is an ordinal response with six Density Levels: negative (lowest density, Score 0); broth only (Score 1); 1+ (Score 2); 2+ (Score 3); 3+ (Score 4); and 4+ (highest density, Score 5). The number of swabs with each score was tabulated from swabs collected at Month 16. Density at missed visits prior to loss to follow-up/final visit was imputed from the subsequent visit.|Month 16|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||Swabs|||Number
707975|NCT00128219|Secondary|The Density of Type III GBS Cultured From Vaginal Swabs at Month 14|The density of type III GBS is an ordinal response with six Density Levels: negative (lowest density, Score 0); broth only (Score 1); 1+ (Score 2); 2+ (Score 3); 3+ (Score 4); and 4+ (highest density, Score 5). The number of swabs with each score was tabulated from swabs collected at Month 14. Density at missed visits prior to loss to follow-up/final visit was imputed from the subsequent visit.|Month 14|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||Swabs|||Number
707976|NCT00128219|Secondary|The Density of Type III GBS Cultured From Vaginal Swabs at Month 12|The density of type III GBS is an ordinal response with six Density Levels: negative (lowest density, Score 0); broth only (Score 1); 1+ (Score 2); 2+ (Score 3); 3+ (Score 4); and 4+ (highest density, Score 5). The number of swabs with each score was tabulated from swabs collected at Month 12. Density at missed visits prior to loss to follow-up/final visit was imputed from the subsequent visit.|Month 12|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||Swabs|||Number
707977|NCT00128219|Secondary|The Density of Type III GBS Cultured From Vaginal Swabs at Month 10|The density of type III GBS is an ordinal response with six Density Levels: negative (lowest density, Score 0); broth only (Score 1); 1+ (Score 2); 2+ (Score 3); 3+ (Score 4); and 4+ (highest density, Score 5). The number of swabs with each score was tabulated from swabs collected at Month 10. Density at missed visits prior to loss to follow-up/final visit was imputed from the subsequent visit.|Month 10|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||Swabs|||Number
707978|NCT00128219|Secondary|The Density of Type III GBS Cultured From Vaginal Swabs at Month 8|The density of type III GBS is an ordinal response with six Density Levels: negative (lowest density, Score 0); broth only (Score 1); 1+ (Score 2); 2+ (Score 3); 3+ (Score 4); and 4+ (highest density, Score 5). The number of swabs with each score was tabulated from swabs collected at Month 8. Density at missed visits prior to loss to follow-up/final visit was imputed from the subsequent visit.|Month 8|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||Swabs|||Number
707979|NCT00128219|Secondary|The Density of Type III GBS Cultured From Vaginal Swabs at Month 6|The density of type III GBS is an ordinal response with six Density Levels: negative (lowest density, Score 0); broth only (Score 1); 1+ (Score 2); 2+ (Score 3); 3+ (Score 4); and 4+ (highest density, Score 5). The number of swabs with each score was tabulated from swabs collected at Month 6. Density at missed visits prior to loss to follow-up/final visit was imputed from the subsequent visit.|Month 6|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||Swabs|||Number
707980|NCT00128219|Secondary|The Density of Type III GBS Cultured From Vaginal Swabs at Month 4|The density of type III GBS is an ordinal response with six Density Levels: negative (lowest density, Score 0); broth only (Score 1); 1+ (Score 2); 2+ (Score 3); 3+ (Score 4); and 4+ (highest density, Score 5). The number of swabs with each score was tabulated from swabs collected at Month 4. Density at missed visits prior to loss to follow-up/final visit was imputed from the subsequent visit.|Month 4|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||Swabs|||Number
707981|NCT00128219|Secondary|The Density of Type III GBS Cultured From Vaginal Swabs at Month 2|The density of type III GBS is an ordinal response with six Density Levels: negative (lowest density, Score 0); broth only (Score 1); 1+ (Score 2); 2+ (Score 3); 3+ (Score 4); and 4+ (highest density, Score 5). The number of swabs with each score was tabulated from swabs collected at Month 2. Density at missed visits prior to loss to follow-up/final visit was imputed from the subsequent visit.|Month 2|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||Swabs|||Number
707982|NCT00128219|Secondary|The Density of Type III GBS Cultured From Vaginal Swabs at Month 1|The density of type III GBS is an ordinal response with six Density Levels: negative (lowest density, Score 0); broth only (Score 1); 1+ (Score 2); 2+ (Score 3); 3+ (Score 4); and 4+ (highest density, Score 5). The number of swabs with each score was tabulated from swabs collected at Month 1. Density at missed visits prior to loss to follow-up/final visit was imputed from the subsequent visit.|Month 1|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||Swabs|||Number
707983|NCT00128219|Secondary|The Density of Type III GBS Cultured From Vaginal Swabs at Month 0|The density of type III GBS is an ordinal response with six Density Levels: negative (lowest density, Score 0); broth only (Score 1); 1+ (Score 2); 2+ (Score 3); 3+ (Score 4); and 4+ (highest density, Score 5). The number of swabs with each score was tabulated from swabs collected at Month 0 prior to vaccination.|Month 0|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||Swabs|||Number
707984|NCT00128219|Secondary|Number of Participants Whose Vaginal Cultures Were Persistently Type III GBS Culture Positive for Three or More Consecutive Visits|Number of vaginal GBS III culture positive for 3+ consecutive visits was calculated from the post-vaccination visits over the 18 month follow-up. Status at missed visits prior to loss to follow-up/final visit was imputed from the subsequent visit.|Every 2 months from time of vaccination up to 18 months post-vaccination.|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||Participants|||Number
707985|NCT00128219|Secondary|Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive.|Number of participants whose vaginal swabs were type III GBS culture positive was calculated using data from the eighteen month post-vaccination follow-up period. Status at missed visits prior to loss to follow-up/final visit was imputed from the previous visit.|Every 2 months from time of vaccination up to 18 months post-vaccination.|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||Participants|||Number
707986|NCT00128219|Secondary|Number of Participants Whose Vaginal Cultures Are Type III GBS Culture Negative Throughout the Study.|Number of participants who were vaginal type III GBS negative was calculated throughout the the eighteen month post-vaccination follow-up period. Status at missed visits prior to loss to follow-up /final visit was imputed from the subsequent visit.|Every 2 months from time of vaccination up to 18 months post-vaccination.|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||Participants|||Number
707987|NCT00128219|Secondary|Number of Participants With a Serum IgG Antibody to Type III GBS Post-Vaccination of 5 µg/mL or Greater at Month 18 Post Vaccination|Blood samples were collected from participants at each scheduled clinic visit, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The threshold for being considered seropositive was 5 µg/mL.|Month 18|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||participants|||Number
707988|NCT00128219|Secondary|Number of Participants With a Serum IgG Antibody to Type III GBS Post-Vaccination of 5 µg/mL or Greater at Month 16 Post Vaccination|Blood samples were collected from participants at each scheduled clinic visit, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The threshold for being considered seropositive was 5 µg/mL.|Month 16|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||participants|||Number
707989|NCT00128219|Secondary|Number of Participants With a Serum IgG Antibody to Type III GBS Post-Vaccination of 5 µg/mL or Greater at Month 14 Post Vaccination|Blood samples were collected from participants at each scheduled clinic visit, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The threshold for being considered seropositive was 5 µg/mL.|Month 14|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||participants|||Number
707990|NCT00128219|Secondary|Number of Participants With a Serum IgG Antibody to Type III GBS Post-Vaccination of 5 µg/mL or Greater at Month 12 Post Vaccination|Blood samples were collected from participants at each scheduled clinic visit, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The threshold for being considered seropositive was 5 µg/mL.|Month 12|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||participants|||Number
707991|NCT00128219|Secondary|Number of Participants With a Serum IgG Antibody to Type III GBS Post-Vaccination of 5 µg/mL or Greater at Month 10 Post Vaccination|Blood samples were collected from participants at each scheduled clinic visit, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The threshold for being considered seropositive was 5 µg/mL.|Month 10|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||participants|||Number
707992|NCT00128219|Secondary|Number of Participants With a Serum IgG Antibody to Type III GBS Post-Vaccination of 5 µg/mL or Greater at Month 8 Post Vaccination|Blood samples were collected from participants at each scheduled clinic visit, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The threshold for being considered seropositive was 5 µg/mL.|Month 8|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||participants|||Number
707993|NCT00128219|Secondary|Number of Participants With a Serum IgG Antibody to Type III GBS Post-Vaccination of 5 µg/mL or Greater at Month 6 Post Vaccination|Blood samples were collected from participants at each scheduled clinic visit, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The threshold for being considered seropositive was 5 µg/mL.|Month 6|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||participants|||Number
707994|NCT00128219|Secondary|Number of Participants With a Serum IgG Antibody to Type III GBS Post-Vaccination of 5 µg/mL or Greater at Month 4 Post Vaccination|Blood samples were collected from participants at each scheduled clinic visit, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The threshold for being considered seropositive was 5 µg/mL.|Month 4|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||participants|||Number
707995|NCT00128219|Secondary|Number of Participants With a Serum IgG Antibody to Type III GBS Post-Vaccination of 5 µg/mL or Greater at Month 2 Post Vaccination|Blood samples were collected from participants at each scheduled clinic visit and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The threshold for being considered seropositive was 5 µg/mL.|Month 2|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||participants|||Number
707996|NCT00128219|Secondary|Number of Participants With a Serum IgG Antibody to Type III GBS Post-Vaccination of 5 µg/mL or Greater at Month 1 Post Vaccination|Blood samples were collected from participants at each scheduled clinic visit and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The threshold for being considered seropositive was 5 µg/mL.|Month 1|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||participants|||Number
707997|NCT00128219|Secondary|Number of Participants With a Serum IgG Antibody to Type III GBS Post-Vaccination of 5 µg/mL or Greater at Month 0|Blood samples were collected from participants at each scheduled clinic visit beginning with Month 0 prior to vaccination, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The threshold for being considered seropositive was 5 µg/mL.|Month 0 prior to vaccination|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||participants|||Number
707998|NCT00128219|Secondary|Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 18 Post-Vaccination|Blood samples were collected from participants prior to vaccination and at 18 months post vaccination, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The lower detection limit for the assay was 0.08 micrograms/milliliter (µg/mL), and antibody levels below this limit were recorded as 0.04 µg/mL by the laboratory. Fold rises compare IgG antibody levels at the post-vaccination visit to that obtained just prior to vaccination. Participants are considered a responder if the antibody increase was four-fold or greater.|Prior to and 18 months following vaccination|All enrolled participants with blood collected at both time points were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||participants|||Number
707999|NCT00128219|Secondary|Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 16 Post-Vaccination|Blood samples were collected from participants prior to vaccination and at 16 months post vaccination, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The lower detection limit for the assay was 0.08 micrograms/milliliter (µg/mL), and antibody levels below this limit were recorded as 0.04 µg/mL by the laboratory. Fold rises compare IgG antibody levels at the post-vaccination visit to that obtained just prior to vaccination. Participants are considered a responder if the antibody increase was four-fold or greater.|Prior to and 16 months following vaccination|All enrolled participants with blood collected at both time points were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||participants|||Number
708000|NCT00128219|Secondary|Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 14 Post-Vaccination|Blood samples were collected from participants prior to vaccination and at 14 months post vaccination, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The lower detection limit for the assay was 0.08 micrograms/milliliter (µg/mL), and antibody levels below this limit were recorded as 0.04 µg/mL by the laboratory. Fold rises compare IgG antibody levels at the post-vaccination visit to that obtained just prior to vaccination. Participants are considered a responder if the antibody increase was four-fold or greater.|Prior to and 14 months following vaccination|All enrolled participants with blood collected at both time points were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||participants|||Number
708001|NCT00128219|Secondary|Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 12 Post-Vaccination|Blood samples were collected from participants prior to vaccination and at 12 months post vaccination, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The lower detection limit for the assay was 0.08 micrograms/milliliter (µg/mL), and antibody levels below this limit were recorded as 0.04 µg/mL by the laboratory. Fold rises compare IgG antibody levels at the post-vaccination visit to that obtained just prior to vaccination. Participants are considered a responder if the antibody increase was four-fold or greater.|Prior to and 12 months following vaccination|All enrolled participants with blood collected at both time points were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||participants|||Number
708002|NCT00128219|Secondary|Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 10 Post-Vaccination|Blood samples were collected from participants prior to vaccination and at 10 months post vaccination, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The lower detection limit for the assay was 0.08 micrograms/milliliter (µg/mL), and antibody levels below this limit were recorded as 0.04 µg/mL by the laboratory. Fold rises compare IgG antibody levels at the post-vaccination visit to that obtained just prior to vaccination. Participants are considered a responder if the antibody increase was four-fold or greater.|Prior to and 10 months following vaccination|All enrolled participants with blood collected at both time points were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||participants|||Number
708003|NCT00128219|Secondary|Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 8 Post-Vaccination|Blood samples were collected from participants prior to vaccination and at 8 month post vaccination, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The lower detection limit for the assay was 0.08 micrograms/milliliter (µg/mL), and antibody levels below this limit were recorded as 0.04 µg/mL by the laboratory. Fold rises compare IgG antibody levels at the post-vaccination visit to that obtained just prior to vaccination. Participants are considered a responder if the antibody increase was four-fold or greater.|Prior to and 8 month following vaccination|All enrolled participants with blood collected at both time points were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||participants|||Number
708004|NCT00128219|Secondary|Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 6 Post-Vaccination|Blood samples were collected from participants prior to vaccination and at 6 months post vaccination, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The lower detection limit for the assay was 0.08 micrograms/milliliter (µg/mL), and antibody levels below this limit were recorded as 0.04 µg/mL by the laboratory. Fold rises compare IgG antibody levels at the post-vaccination visit to that obtained just prior to vaccination. Participants are considered a responder if the antibody increase was four-fold or greater.|Prior to and 6 months following vaccination|All enrolled participants with blood collected at both time points were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||participants|||Number
708005|NCT00128219|Secondary|Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 4 Post-Vaccination|Blood samples were collected from participants prior to vaccination and at 4 months post vaccination, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The lower detection limit for the assay was 0.08 micrograms/milliliter (µg/mL), and antibody levels below this limit were recorded as 0.04 µg/mL by the laboratory. Fold rises compare IgG antibody levels at the post-vaccination visit to that obtained just prior to vaccination. Participants are considered a responder if the antibody increase was four-fold or greater.|Prior to and 4 months following vaccination|All enrolled participants with blood collected at both time points were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||participants|||Number
708006|NCT00128219|Secondary|Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 2 Post-Vaccination|Blood samples were collected from participants prior to vaccination and at 2 months post vaccination, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The lower detection limit for the assay was 0.08 micrograms/milliliter (µg/mL), and antibody levels below this limit were recorded as 0.04 µg/mL by the laboratory. Fold rises compare IgG antibody levels at the post-vaccination visit to that obtained just prior to vaccination. Participants are considered a responder if the antibody increase was four-fold or greater.|Prior to and 2 months following vaccination|All enrolled participants with blood collected at both time points were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||participants|||Number
708007|NCT00128219|Secondary|Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 1 Post-Vaccination|Blood samples were collected from participants prior to vaccination and at 1 month post vaccination, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The lower detection limit for the assay was 0.08 micrograms/milliliter (µg/mL), and antibody levels below this limit were recorded as 0.04 µg/mL by the laboratory. Fold rises compare IgG antibody levels at the post-vaccination visit to that obtained just prior to vaccination. Participants are considered a responder if the antibody increase was four-fold or greater.|Prior to and 1 month following vaccination|All enrolled participants with blood collected at both time points were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||participants|||Number
708008|NCT00128219|Secondary|Mean Fold-Rise in Serum IgG Antibody Levels to Type III GBS Post-Vaccination|Fold-rises compare the IgG antibody level at post-vaccination to that obtained just prior to vaccination, for each visit during the 18-month follow-up period. Assay results at missed visits prior to loss to follow-up/final visit were not imputed.|Prior to and at 1, 2, 4, 6, 8, 10, 12, 14, 16, and 18 months following vaccination.|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||Ratio||95% Confidence Interval|Mean
708009|NCT00128219|Secondary|Number of Participants With Any Solicited Local and Systemic Symptoms.|Participants maintained a diary card to report the occurrence of solicited local and systemic symptoms for 7 days after vaccination. Participants are counted if they indicated experiencing the symptom at any severity during the reporting period.|Safety surveillance during the 1st 7 days.|The Safety Analysis Cohort is comprised of all vaccinated women, categorized according to the product received, regardless of their randomized assignment. Due to vaccination errors, the number of participants in the Td group for the Safety Analysis Cohort (n=337) exceeds the number randomized to this group (n=334).||Participants|||Number
708010|NCT00128219|Secondary|Geometric Mean Concentration (GMC) of Serum Immunoglobulin G (IgG) Antibody Levels to Type III GBS Post-Vaccination.|The GMC was calculated from IgG antibody to type III GBS assay results on serum specimens obtained at clinic visits during the 18 month post-vaccination follow-up period. Results at missed visits prior to loss to follow-up/final visit were not imputed.|Prior to and at 1, 2, 4, 6, 8, 10, 12, 14, 16, and 18 months following vaccination.|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||µg/ml||95% Confidence Interval|Geometric Mean
708069|NCT00128830|Secondary|Median Change in Cluster of Differentiation 4 (CD4+) Cell Count From Baseline in TMC125-C229 Feeder Study at Week 96|Baseline considered for this outcome is the baseline in the respective TMC125-C229 feeder study (TMC125-C203 [NCT00412646], TMC125-C223 [NCT00081978], TMC125 C211 [NCT00111280] or TMC125-C209 feeder studies).|Week 96|Intent-to-treat participants who received at least one dose of study medication with evaluable data at Week 96||x 1000000 cells/mL||Full Range|Median
708011|NCT00128219|Primary|The Time to First Vaginal Swab That is Type III GBS Culture Positive, With All Previous Cultures Negative for Type III GBS, Not Just the Immediately Preceding Culture.|Time to first acquisition of vaginal type III GBS was calculated as time from vaccination to the mid-point of the interval of ascertainment, censored by either the end of the follow-up period, or the first of 2 or more consecutive missed visits. Vaginal type III GBS status at missed visits prior to censoring was imputed from the subsequent visit.|Time from vaccination to acquisition of vaginal type III GBS, up to 18 months post-vaccination.|All enrolled participants with at least one post-enrollment efficacy assessment were included in the intention to treat (ITT) Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||Participants|||Number
708012|NCT00128401|Secondary|Liebowitz Social Anxiety Scale (LSAS)|"Social anxiety symptoms were assessed using the Liebowitz Social Anxiety Scale (LSAS). It is a 24-item self-report instrument that measures overall social anxiety fear and avoidance symptoms. This is the baseline assessment. The 24 items are each rated twice, from a 0 to 3 scale, with 0 indicated no level of symptom and 3 indicating a high level of the system. One rating is for anxiety, and the other is for avoidance. Thus, the lowest possible score is 0, and the highest possible score is 144. The total score represents the simple sum of all 48 ratings."|12 weeks post baseline|The analyses included only those subjects who were assigned to the DCS condition and placebo||units on a scale||Standard Deviation|Mean
708013|NCT00128401|Primary|Clinical Global Improvement (CGI-S) Scale|Symptom severity and improvement was assessed using the Clinical Global Impressions scale (CGI). It is a 2-item clinician-administered instrument that measures the patients' illness severity and global improvement. The minimum value for the CGI is 1=Normal, not at all ill and the maximum value is 7=Among the most extremely ill patients.|12 weeks post baseline|The analyses included only those subjects who were assigned to the DCS condition and placebo||units on a scale||Standard Deviation|Mean
708014|NCT00128492|Primary|Serum Chemistry - Concentration of Total Protein||Baseline and end of treatment Course 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.||g/dL||Standard Deviation|Mean
708015|NCT00128492|Primary|Serum Chemistry - Concentration of Chloride, Potassium, and Sodium||Baseline and end of treatment Course 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.||mEq/L||Standard Deviation|Mean
708016|NCT00128492|Primary|Serum Chemistry - Concentration of Calcium, Creatinine, Direct Bilirubin, Total Bilirubin, Serum Glucose, and Blood Urea Nitrogen||Baseline and end of treatment Course 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.||mg/dL||Standard Deviation|Mean
708017|NCT00128492|Primary|Serum Chemistry - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma-glutamlytransferase (GGT)||Baseline and end of treatment Course 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.||U/L||Standard Deviation|Mean
708018|NCT00128492|Primary|Serum Hematology - Mean Corpuscular Hemoglobin Concentration (MCHC)||Baseline and end of treatment Course 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.||g/dL||Standard Deviation|Mean
708019|NCT00128492|Primary|Serum Hematology - Mean Corpuscular Hemoglobin (MCH)||Baseline and end of treatment Course 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.||pg||Standard Deviation|Mean
708020|NCT00128492|Primary|Serum Hematology - Mean Corpuscular Volume (MCV)||Baseline and end of treatment Course 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.||fL||Standard Deviation|Mean
708021|NCT00128492|Primary|Serum Hematology - Hemoglobin||Baseline and end of treatment Course 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.||g/dL||Standard Deviation|Mean
708022|NCT00128492|Primary|Serum Hematology - Hematocrit||Baseline and end of treatment Course 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.||percent||Standard Deviation|Mean
708023|NCT00128492|Primary|Serum Hematology - Number of Red Blood Cells (RBC)||Baseline and end of treatment Course 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.||number x10^6/µL||Standard Deviation|Mean
708024|NCT00128492|Primary|Serum Hematology - Percent of Differential for Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils||Baseline and end of treatment Course 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.||percent of differential||Standard Deviation|Mean
708025|NCT00128492|Primary|Serum Hematology - Concentration of White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets||Baseline and end of Course 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI. Results obtained at the end of a 28-day treatment period are presented for selected timepoints.||number of cells x10^3/µL||Standard Deviation|Mean
708026|NCT00128492|Primary|Change in Respiratory Rate (RR)|"RR was recorded at all visits.
Change from baseline at the end of AZLI treatment Courses 1 (Visit 2), 3 (Visit 4), and 9 (Visit 19) was determined."|Baseline, and end of treatment Courses 1 (Week 4), 3 (Week 20) and 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.||breaths/minute||Standard Deviation|Mean
708027|NCT00128492|Primary|Change in Temperature|"Temperature was recorded at all visits.
Change from baseline at the end of AZLI treatment Courses 1 (Visit 2), 3 (Visit 4), and 9 (Visit 19) was determined."|Baseline, and end of treatment Courses 1 (Week 4), 3 (Week 20) and 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.||degrees Celsius||Standard Deviation|Mean
708028|NCT00128492|Secondary|Time to Intravenous (IV) Antipseudomonal Antibiotics|Use of IV antipseudomonal antibiotics was compiled from data recorded on the Concomitant Medications eCRF. The time to first IV antipseudomonal antibiotic use was the number of days from baseline (Visit 1) to the date of first IV antipseudomonal antibiotic use or the date of study completion (last visit) /or early withdrawal if censored.|Overall study (72 weeks) included nine 28-day courses of study drug alternating with nine 28-day courses off drug|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.||Days||95% Confidence Interval|Median
708029|NCT00128492|Secondary|Missed School/Work Days Due to CF Symptoms|"Participants were provided with a diary card at each visit to record days of work and/or school missed due to their CF symptoms.
The percentage of school/work days missed was calculated as the total number of school/work days missed divided by the total number of on-study days multiplied by 100 across all participants in a treatment group."|Overall study (72 weeks) included nine 28-day courses of study drug alternating with nine 28-day courses off drug|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.||Percentage of days missed||Standard Deviation|Mean
708030|NCT00128492|Secondary|Change in Body Weight|Weight was measured at all visits and was reported to the nearest 0.1 kg/lb. Percent change in weight from baseline was calculated.|Baseline, and end of treatment Courses 1 (Week 4), 3 (Week 20), and 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.||Percent change from baseline||Standard Error|Mean
708031|NCT00128492|Secondary|Time to First Hospitalization Due to a Respiratory Event|"Details of all hospitalizations, including the dates of admission and discharge, were recorded on the serious adverse event (SAE) electronic case report form (eCRF).
Time to first hospitalization was the number of days from baseline (Visit 1) to the date of first hospitalization or the date of study completion (last visit) /or early withdrawal if censored."|Overall study (72 weeks) included nine 28-day courses of study drug alternating with nine 28-day courses off drug|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.||Days||Full Range|Median
708032|NCT00128492|Secondary|Change in Clinical Symptoms as Assessed by the Cystic Fibrosis Questionnaire-Revised Respiratory Symptom Scale (CFQ-R RSS)|The CFQ-R was administered at baseline and every visit thereafter. The endpoint was change in respiratory symptoms from baseline, assessed with the CFQ-R RSS (range of scores: 0-100; higher scores indicate fewer symptoms). The minimal clinically important difference (MCID) corresponds to the smallest change in symptoms that a patient can detect and is a change in score of 4 points.|Baseline, and end of treatment Courses 1 (Week 4), 3 (Week 20), and 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.||Units on a scale||Standard Deviation|Mean
708033|NCT00128492|Secondary|Percent Change in Pulmonary Function (FEV1, FEV1 Percent Predicted, FVC, FEF25-75)|"Spirometry was performed at each visit. FEV1, FVC, and FEF25-75 were recorded at all visits according to American Thoracic Society (ATS) guidelines.
FEV1 = the volume of air exhaled in 1 second. FEV1 % predicted is a normalized value of FEV1 calculated using the Knudson equation, based upon participant age, gender, and height. FVC = (forced vital capacity) the maximal volume of air exhaled with maximally forced effort from a position of maximal inspiration. FEF25-75 = forced expiratory flow from 25% to 75% of the FVC.
The percent change from baseline is presented for each endpoint."|Baseline, and end of treatment Courses 1 (Week 4), 3 (Week 20), and 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.||Percent change from baseline||Standard Deviation|Mean
708034|NCT00128492|Secondary|Minimum Inhibitory Concentration (MIC) of Aztreonam|"The aztreonam susceptibility of PA isolates from expectorated sputum samples (collected at all visits) was assessed.
MIC50 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 50% of isolates from a particular organism).
MIC90 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 90% of isolates from a particular organism).
MIC50 and MIC90 values are single measurements for the entire population and not measured on a per-participant basis."|Baseline; end of treatment Courses 1 (Week 4), 3 (Week 20), and 9 (Week 68); and at Follow-up (Week 72)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.||µg/mL|||Number
708035|NCT00128492|Secondary|Number of Participants With Other Pathogens|"Sputum samples were collected at all study visits for qualitative and quantitative culture for Burkholderia cepacia complex (BCC), Stenotrophomonas maltophilia, Achromobacter xylosoxidans, Staphylococcus aureus (including methicillin-sensitive [MSSA] and methicillin-resistant [MRSA] S.aureus), and fungal organisms.
Number of participants with other pathogens at baseline and end of AZLI treatment Courses 1, 3, and 9 are reported."|Baseline; end of treatment Courses 1 (Week 4), 3 (Week 20), and 9 (Week 68); and at Follow-up (Week 72)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.||Participants|||Number
708036|NCT00128492|Secondary|Change From Baseline in Pseudomonas Aeruginosa (PA) log10 Colony-forming Units (CFU) Per Gram of Sputum|"Sputum samples were collected at all participant visits of the study for analysis of microbiology endpoints. Sputum samples were processed for qualitative and quantitative culture of PA (each morphotype).
Due to the skewness of the distribution of CFU data, the data were transformed using the base 10 logarithm, in an attempt to normalize the data and allow for parametric tests, before calculating changes. To account for zero values, 1 was added to each CFU measurement before being transformed. Any CFU data values where PA was not isolated from a valid culture were set to zero."|Baseline, and the end of treatment Courses 1 (Week 4), 3 (Week 20), and 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.||Log10 PA CFUs/g||Standard Deviation|Mean
708037|NCT00128492|Primary|Change in Systolic and Diastolic Blood Pressure (BP)|"BP was recorded at all visits.
Change from baseline at the end of AZLI treatment Courses 1 (Visit 2), 3 (Visit 4), and 9 (Visit 19) was determined."|Baseline, and end of treatment Courses 1 (Week 4), 3 (Week 20) and 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.||mm Hg||Standard Deviation|Mean
708038|NCT00128492|Primary|Change in Heart Rate (HR)|"HR was recorded at all visits.
Change from baseline at the end of AZLI treatment Courses 1 (Visit 2), 3 (Visit 4), and 9 (Visit 19) was determined."|Baseline, and end of treatment Courses 1 (Week 4), 3 (Week 20) and 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.||beats/minute||Standard Deviation|Mean
708039|NCT00128492|Primary|Number of Subjects With <15% or ≥15% Decline in Forced Expiratory Volume in 1 Second [FEV1] From Pretreatment to 30 Minutes After Treatment With AZLI|Airway reactivity (percent change in FEV1 from pretreatment to 30 minutes after treatment with AZLI) was assessed at all study visits in which a participant received AZLI treatment. A participant was included in this endpoint if they experienced a decline in FEV1 of ≥15% at any visit in which they received AZLI.|Overall study (72 weeks) included nine 28-day courses of study drug alternating with nine 28-day courses off drug|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.||Participants|||Number
708040|NCT00128492|Primary|Number of Participants Reporting Adverse Events (AEs)|"Participants experiencing at least 1 treatment-emergent AE or at least 1 serious adverse event (SAE) were summarized for the study as a whole. A treatment-emergent AE was any physical or clinical worsening in symptoms or disease experienced by the participant, whether or not the event was considered related to study participation or study procedures. An SAE was any adverse experience that resulted in hospitalization or death.
Participants were monitored for AEs and SAEs during all on-treatment and off-treatment intervals throughout the 18-month study period."|Overall study (72 weeks) included nine 28-day courses of study drug alternating with nine 28-day courses off drug|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.||participants|||Number
708041|NCT00128661|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs).|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|within 30 days (Days 0-29) after vaccination|The Total Vaccinated cohort included all vaccinated subjects with at least 1 vaccine administration documented.||Subjects|||Number
708042|NCT00128661|Secondary|Number of Cervical Infection With HPV16 or HPV18.|Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) (by PCR) at Month 0 and Month 6 for the corresponding HPV-type|From the fourth year follow-up period|The According-To-Protocol (ATP) cohort for efficacy included subjects with efficacy data available, who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and at the time of administration of the 3rd dose (Month 6) and who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6).||Events|||Number
708043|NCT00128661|Secondary|Number of Cervical Infection With HPV16 or HPV18.|Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) (by PCR) at Month 0 and Month 6 for the corresponding HPV-type|During the third year of follow-up period|The According-To-Protocol (ATP) cohort for efficacy included subjects with efficacy data available, who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and at the time of administration of the 3rd dose (Month 6) and who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6).||Events|||Number
708044|NCT00128661|Secondary|Number of Cervical Infection With HPV16 or HPV18.|Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) (by PCR) at Month 0 and Month 6 for the corresponding HPV-type|During the second year of follow-up period|The According-To-Protocol (ATP) cohort for efficacy included subjects with efficacy data available, who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and at the time of administration of the 3rd dose (Month 6) and who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6).||Events|||Number
708045|NCT00128661|Secondary|Number of Cervical Infection With HPV16 or HPV18.|Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) (by PCR) at Month 0 and Month 6 for the corresponding HPV-type|During the first year of follow-up period|The According-To-Protocol (ATP) cohort for efficacy included subjects with efficacy data available, who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and at the time of administration of the 3rd dose (Month 6) and who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6).||Events|||Number
708046|NCT00128661|Secondary|Number of Subjects With All Possible Pregnancy Outcomes|The range of possible pregnancy outcomes was: Pregnancy loss, Pregnancy resolved alive, and Unresolved pregnancy.|During the entire study period (From Month 0 up to Month 48).|The analysis was performed on the Total Vaccinated Cohort, on all pregnant subjects.||subjects|||Number
708047|NCT00128661|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs).|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the entire study period (From Month 0 up to Month 48).|The Total Vaccinated cohort included all vaccinated subjects with at least 1 vaccine administration documented.||Subjects|||Number
708048|NCT00128661|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|During the entire study period (From Month 0 up to Month 48).|The Total Vaccinated cohort included all vaccinated subjects with at least 1 vaccine administration documented.||Subjects|||Number
708049|NCT00128661|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms on a 10% Random Subset of Participants.|Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, urticaria and fever (Fever = oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)). Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal everyday activities as assessed by inability to attend work or school and which necessitated the administration of corrective therapy.Grade 3 urticaria = urticaria distributed on at least 4 body areas. Grade 3 fever = oral temperature > 39.0°C.|From Day 3 to Day 6 after vaccination|The Total Vaccinated cohort included all vaccinated subjects with at least 1 vaccine administration documented.||Subjects|||Number
708050|NCT00128661|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms on a 10% Random Subset of Participants.|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal everyday activities as assessed by inability to attend work or school and which necessitated the administration of corrective therapy. Grade 3 redness and swelling was defined as redness/swelling above 50 millimeter (mm).|From Day 3 to Day 6 after vaccination|The Total Vaccinated cohort included all vaccinated subjects with at least 1 vaccine administration documented.||Subjects|||Number
708654|NCT00138671|Secondary|Baseline Dyspnea Index (BDI) and Transition Dyspnea Index (TDI) Questionnaires|The BDI and TDI measured or quantitated the severity of breathlessness (shortness of breath) in symptomatic subjects. BDI and TDI data were collected, but not analyzed.|Duration of the study|||grade|||Number
708051|NCT00128661|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms.|Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, urticaria and fever (Fever = oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)). Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal everyday activities as assessed by inability to attend work or school and which necessitated the administration of corrective therapy.Grade 3 urticaria = urticaria distributed on at least 4 body areas. Grade 3 fever = oral temperature > 39.0°C.|Within 60 minutes after vaccination|The Total Vaccinated cohort included all vaccinated subjects with at least 1 vaccine administration documented.||Subjects|||Number
708052|NCT00128661|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal everyday activities as assessed by inability to attend work or school and which necessitated the administration of corrective therapy. Grade 3 redness and swelling was defined as redness/swelling above 50 millimeter (mm).|Within 60 minutes after vaccination|The Total Vaccinated cohort included all vaccinated subjects with at least 1 vaccine administration documented.||Subjects|||Number
708053|NCT00128661|Secondary|HPV-18 Geometric Mean Titers (GMTs) (J4 Monoclonal Antibody Inhibition Test)|"Titers were assessed for the 600 subjects enrolled into the immunogenicity subcohort by Inhibition Enzyme Immunoassay (EIA) and expressed as geometric mean antibody titers (GMTs).
Seronegative (Sero-) subjects=antibody concentration below 110 EL.U/mL prior to vaccination.
Seropositive (Sero+) subjects=antibody concentration equal to or above 110 EL.U/mL prior to vaccination.
Immunogenicity subcohort=subset of 600 subjects from the 2 groups of the ATP cohort: subjects attended 1 extra clinic visit approximately 1 month (30 to 60 days) after the last dose was administered (Month 7)."|Before vaccination and at Month 1, 6, 7, 12, 18, 24, 30, 36, 42 and 48|The ATP cohort for immunogenicity included subjects who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and during the 48-month follow-up period, who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6) and for whom immunogenicity results were available.||Titers||95% Confidence Interval|Geometric Mean
708054|NCT00128661|Secondary|HPV-16 Geometric Mean Titers (GMTs) (V5 Monoclonal Antibody Inhibition Test)|"Titers were assessed for the 600 subjects enrolled into the immunogenicity subcohort by Inhibition Enzyme Immunoassay (EIA) and expressed as geometric mean antibody titers (GMTs).
Seronegative (Sero-) subjects=antibody concentration below 41 EL.U/mL prior to vaccination.
Seropositive (Sero+) subjects=antibody concentration equal to or above 41 EL.U/mL prior to vaccination.
Immunogenicity subcohort=subset of 600 subjects from the 2 groups of the ATP cohort: subjects attended 1 extra clinic visit approximately 1 month (30 to 60 days) after the last dose was administered (Month 7)."|Before vaccination and at Month 1, 6, 7, 12, 18, 24, 30, 36, 42 and 48|The ATP cohort for immunogenicity included subjects who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and during the 48-month follow-up period, who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6) and for whom immunogenicity results were available.||Titers||95% Confidence Interval|Geometric Mean
708055|NCT00128661|Secondary|Geometric Mean Titers (GMTs) for HPV-18 Antibody in the Immunogenicity Subcohort|"Titers were assessed for the 600 subjects enrolled into the immunogenicity subcohortby Enzyme linked immunosorbent assay (ELISA) and expressed as geometric mean titers (GMTs).
Seronegative (Sero-) subjects=antibody concentration below 7 EL.U/mL prior to vaccination.
Seropositive (Sero+) subjects=antibody concentration equal to or above 7 EL.U/mL prior to vaccination.
Immunogenicity subcohort=subset of 600 subjects from the 2 groups of the ATP cohort: subjects attended 1 extra clinic visit approximately 1 month (30 to 60 days) after the last dose was administered (Month 7)."|Before vaccination and at Month 1, 6, 7, 12, 18, 24, 30, 36, 42 and 48|The ATP cohort for immunogenicity included subjects who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and during the 48-month follow-up period, who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6) and for whom immunogenicity results were available.||Titers||95% Confidence Interval|Geometric Mean
708056|NCT00128661|Secondary|Geometric Mean Titers (GMTs) for HPV-16 Antibody in the Immunogenicity Subcohort.|"Titers were assessed for the 600 subjects enrolled into the immunogenicity subcohort by Enzyme linked immunosorbent assay (ELISA) and expressed as geometric mean titers (GMTs).
Seronegative subjects = antibody concentration below 8 ELISA Units per millilitre (EL.U/mL) prior to vaccination.
Seropositive subjects=antibody concentration equal to or above 8 EL.U/mL prior to vaccination.
Immunogenicity subcohort = subset of 600 subjects from the 2 groups of the ATP cohort: subjects attended 1 extra clinic visit approximately 1 month (30 to 60 days) after the last dose was administered (Month 7)"|Before vaccination and at Month 1, 6, 7, 12, 18, 24, 30, 36, 42 and 48|The ATP cohort for immunogenicity included subjects who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and during the 48-month follow-up period, who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6) and for whom immunogenicity results were available.||Titers||95% Confidence Interval|Geometric Mean
708057|NCT00128661|Secondary|Number of Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 Cases|"Persistent incident HPV-16 and /or HPV-18 cervical infection had to fulfil the following criteria: first detection after the 6-month visit, 2 same type HPV positive (by PCR) test results 10+ months apart, and no intervening HPV negative tests for the corresponding type.
Persistent HPV16 or HPV18 cervical infection = detection of the same HPV type by polymerase chain reaction (PCR) in cervical samples from all consecutive evaluations over approximately 12 months.
Subjects were HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type."|From Month 6 up to Month 48|The According-To-Protocol (ATP) cohort for efficacy included subjects with efficacy data available, who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and at the time of administration of the 3rd dose (Month 6) and who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6).||Events|||Number
708070|NCT00128830|Secondary|Median Change From TMC125-C229 Baseline in Cluster of Differentiation 4 (CD4+) Cell Count at Week 96|The last visit of the TMC125 feeder study (TMC125-C203 [NCT00412646], TMC125-C223 [NCT00081978], TMC125 C211 [NCT00111280] or TMC125-C209 feeder studies) was considered to be the TMC125-C229 baseline.|Week 96|Intent-to-treat participants who received at least one dose of study medication with evaluable data at Week 96||x 1000000 cells/L||Full Range|Median
708058|NCT00128661|Secondary|Number of Histopathologically Confirmed CIN2+ Cases Associated With Infection by Any Oncogenic HPV Type|"Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 and 68 detected by polymerase chain reaction (PRC) in the preceding cervical cytology specimen.
Note: The assay did not distinguish between HPV types 68 and 73.
CIN2+ was defined as CIN grade 2 (CIN2), CIN grade 3 (CIN3), adenocarcinoma in situ (AIS) or invasive cervical cancer
Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) (by PCR) at Month 0 and Month 6 for the corresponding HPV-type"|From Month 6 up to Month 48|The According-To-Protocol (ATP) cohort for efficacy included subjects with efficacy data available, who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and at the time of administration of the 3rd dose (Month 6) and who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6).||Events|||Number
708059|NCT00128661|Secondary|Number of Cervical Infection With HPV16 or HPV18.|Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) (by PCR) at Month 0 and Month 6 for the corresponding HPV-type|From Month 6 up to Month 48|The According-To-Protocol (ATP) cohort for efficacy included subjects with efficacy data available, who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and at the time of administration of the 3rd dose (Month 6) and who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6).||Events|||Number
708060|NCT00128661|Primary|Number of Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Cases Associated With HPV16 and/or HPV18 Infection Detected in the Preceding Cervical Cytology Specimen.|"CIN2+ was defined as CIN grade 2 (CIN2), CIN grade 3 (CIN3), adenocarcinoma in situ (AIS) or invasive cervical cancer.
Preceding cervical cytology means the last cervical cytology specimen collected before the histopathology specimen was obtained.
Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) by polymerase chain reaction (PCR) at Month 0 and Month 6 for the corresponding HPV-type."|From Month 6 up to Month 48|The According-To-Protocol (ATP) cohort for efficacy included subjects with efficacy data available, who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and at the time of administration of the 3rd dose (Month 6) and who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6).||Events|||Number
708061|NCT00128713|Secondary|Highest Grade of Bleeding While on Study|Highest grade of bleeding during time on study using Platelet Dose Trial modification of World Health Organization Bleeding Scale. Grades 0-1 (no or minimal bleeding), 2 (moderate bleeding), 3 (bleeding generally requiring red cell transfusion), 4 (severe bleeding)|From randomization until the subject ends the study (10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or hospital discharge, whichever occurs first)|The analysis was done as intention to treat. Subjects for which highest grade of bleeding could not be determined (non-evaluable) were excluded.||participants|||Number
708062|NCT00128713|Secondary|Bleeding Severity, if a Suitable Scale is Validated and Published by the Time the Trial Ends|No suitable scale was identified, so no analyses for this outcome were carried out|From randomization until the subject ends the study (10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or hospital discharge, whichever occurs first)|Analysis not performed; no applicable bleeding severity scale validated and published by end of PLADO Study|||||
708063|NCT00128713|Secondary|Number of Platelet Transfusion Episodes|Number of platelet transfusion episodes among subjects who have at least one platelet transfusion and no missing data on attempted doses.|From randomization until the subject ends the study (10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or hospital discharge, whichever occurs first)|Subjects with missing information and those that did not receive at least one platelet transfusion were excluded from the analysis.||Number of platelet transfusion episodes||Full Range|Median
708064|NCT00128713|Secondary|Platelet Utilization|Total number of platelets transfused, based on attempted dose, among subjects who have at least one platelet transfusion and no missing data on attempted doses.|From randomization until the subject ends the study (10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or hospital discharge, whichever occurs first)|Subjects with missing information and those that did not receive at least one platelet transfusion were excluded from the analysis.||Number of platelets (x10^11)||Full Range|Median
708065|NCT00128713|Primary|At Least One Day With Grade 2 or Higher Bleeding|Any Grade 2 (moderate) or higher grade bleeding, as determined by daily hemostatic assessment and documentation of any red blood cell transfusions to treat bleeding|From randomization until the subject ends the study (10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or hospital discharge, whichever occurs first)|These analyses were done on an intention-to-treat basis. That is, patients were counted in the treatment arm to which they were randomly assigned, even if they actually received transfusions that were not according to their assigned dosing strategy.||participants|||Number
708066|NCT00128830|Primary|Number of Participants With Adverse Events|Number of participants who reported at least 1 of the adverse events.|Up to 3 years|Intent-to-treat population: Participants who received at least 1 dose of study medication were included||Participants|||Number
708067|NCT00128830|Secondary|Number of Participants With Emerging Mutation (Reverse Transcriptase Mutation)|Emerging mutations are the mutation which are not present at baseline (last visit of the TMC125 feeder study [TMC125-C203 (NCT00412646), TMC125-C223 (NCT00081978), TMC125 C211 (NCT00111280) or TMC125-C209 feeder studies]) and are present at endpoint (last available timepoint during treatment period for each individual participant).|Baseline and Endpoint (ie, the last available time point during the treatment period)|Intent-to-treat population: Participants who received at least 1 dose of study medication were included||Participants|||Number
708068|NCT00128830|Secondary|Median Change in Cluster of Differentiation 4 (CD4+) Cell Count From Baseline in TMC125-C229 Feeder Study at Week 192|Baseline considered for this outcome is the baseline in the respective TMC125-C229 feeder study (TMC125-C203 [NCT00412646], TMC125-C223 [NCT00081978], TMC125 C211 [NCT00111280] or TMC125-C209 feeder studies).|Week 192|Intent-to-treat participants who received at least one dose of study medication with evaluable data at Week 192||x 1000000 cells/mL||Full Range|Median
708274|NCT00124176|Secondary|Change in Pediatric Asthma Severity Score|"Change in Pediatric Asthma Severity Score. Range 0 (best) - 6 (worst)
Score at each time point is calculated by adding 3 elements:
Wheeze (0= None/Mild, 1=Moderate, 2=Severe) Prolonged expiration (0= None/Mild, 1=Moderate, 2=Severe) Work of breathing (0= None/Mild, 1=Moderate, 2=Severe)"|After 12 hours of continuous nebulization|||units on a scale||Standard Deviation|Mean
708071|NCT00128830|Secondary|Median Change From TMC125-C229 Basline in Cluster of Differentiation 4 (CD4+) Cell Count at Week 48|The last visit of the TMC125 feeder study (TMC125-C203 [NCT00412646], TMC125-C223 [NCT00081978], TMC125 C211 [NCT00111280] or TMC125-C209 feeder studies) was considered to be the TMC125-C229 baseline.|Week 48|Intent-to-treat participants who received at least one dose of study medication with evaluable data at Week 48||x 100000 cells/L||Full Range|Median
708072|NCT00128830|Secondary|Number of Participants Who Achieved Virologic Response (ie, Viral Load Less Than 50 Copies/mL; Viral Load Less Than 400 Copies/mL; and Greater Than or Equal to 1 log10 Decrease From Baseline) at Week 192|Baseline considered for this outcome is the baseline in the respective TMC125-C229 feeder study (TMC125-C203 [NCT00412646], TMC125-C223 [NCT00081978], TMC125 C211 [NCT00111280] or TMC125-C209 feeder studies).|Week 192|Intent-to-treat participants who received at least one dose of study medication with evaluable data at Week 192||Participants|||Number
708073|NCT00128830|Secondary|Number of Participants Who Achieved Virologic Response (ie, Viral Load Less Than 50 Copies/mL; Less Than 400 Copies/mL; and Greater Than or Equal to 1 Log 10 Decrease From Baseline) at Week 96|Baseline considered for this outcome is the baseline in the respective TMC125-C229 feeder study (TMC125-C203 [NCT00412646], TMC125-C223 [NCT00081978], TMC125 C211 [NCT00111280] or TMC125-C209 feeder studies).|Week 96|Intent-to-treat participants who received at least one dose of study medication with evaluable data at Week 96||Participants|||Number
708074|NCT00128830|Secondary|Number of Participants Who Achieved Virologic Response (ie, Viral Load Less Than 50 Copies/mL) at Week 96|Number of participants who had viral load more than or equal to 50 copies/mL and less than 50 copies/mL at TMC125-C229 baseline and who achieved virologic response (ie, viral load less than 50 copies/mL) at Week 96. The last visit of the TMC125 feeder study (TMC125-C203 [NCT00412646], TMC125-C223 [NCT00081978], TMC125 C211 [NCT00111280] or TMC125-C209 feeder studies) was considered to be the TMC125-C229 baseline.|Week 96|Intent-to-treat participants who received at least one dose of study medication with evaluable data at Week 96||Participants|||Number
708075|NCT00128830|Secondary|Number of Participants Who Achieved Virologic Response (ie, Viral Load Less Than 50 Copies/mL) at Week 48|Number of participants who had viral load more than or equal to 50 copies/mL and less than 50 copies/mL at TMC125-C229 baseline and who achieved virologic response (ie, viral load less than 50 copies/mL) at Week 48. The last visit of the TMC125 feeder study (TMC125-C203 [NCT00412646], TMC125-C223 [NCT00081978], TMC125 C211 [NCT00111280] or TMC125-C209 feeder studies) was considered to be the TMC125-C229 baseline.|Week 48|Intent-to-treat participants who received at least one dose of study medication with evaluable data at Week 48||Participants|||Number
708076|NCT00128921|Primary|Number of Participants With a Positive Response to Bortezomib Measured by Bone Markers Like Phosphate.|Phosphate: any Phosphate increase would refer to a positive response.|6 months|||participants|||Number
708077|NCT00128921|Primary|Number of Participants With a Positive Response to Bortezomib Measured by Bone Markers Like Magnesium|Magnesium: Any Magnesium increase would refer to a positive response.|6 months|||participants|||Number
708078|NCT00128921|Primary|Number of Participants With a Positive Response to Bortezomib Measured by Bone Marker Alkaline Phosphatase|Alkaline phosphatase: If the Alkaline phosphatase increases it's considered positive response|6 months|||participants|||Number
708079|NCT00128921|Secondary|Number of Participants With a Positive Response to Bortezomib Measured by Bone Marker Osteocalcin|Osteocalcin: Any Osteocalcin increase means positive response.|6 months|||participants|||Number
708080|NCT00128921|Primary|Number of Participants With a Positive Response to Bortezomib Measured by Bone Markers Like Calcium|Calcium: any Calcium increase would refer to a positive response.|6 months|||participants|||Number
708081|NCT00128921|Primary|Number of Participants With a Positive Response to Bortezomib Measured by the Bone Marker Parathyroid Hormone|Parathyroid hormone: Any increase in PTH was considered response|6 months|||participants|||Number
708082|NCT00129116|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|Over the full course of the booster phase (up to study Month 1 – booster phase)|The Booster Total Vaccinated Cohort included all subjects who received the booster dose.||Subjects|||Number
708083|NCT00129116|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31-day (Day 0-30) follow-up period (during the booster phase)|The Booster Total Vaccinated Cohort included all subjects who received the booster dose.||Subjects|||Number
708084|NCT00129116|Secondary|Number of Subjects With Solicited General Symptoms|Solicited general symptoms assessed were drowsiness, irritability, loss of appetite and fever (fever is defined as rectal temperature ≥ 38.0 degrees Celsius (°C)).|During the 8-day (Day 0-7) follow-up period (during the booster phase)|The Booster Total Vaccinated Cohort included all subjects who received the booster dose.||Subjects|||Number
708085|NCT00129116|Secondary|Number of Subjects With Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling.|During the 8-day (Day 0-7) follow-up period (during the booster phase)|The Booster Total Vaccinated Cohort included all subjects who received the booster dose.||Subjects|||Number
708086|NCT00129116|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|Over the full course of the primary phase (up to study Month 3 – primary phase)|The Total Vaccinated Cohort included all subjects with study vaccine administered for whom data were available.||Subjects|||Number
708101|NCT00129116|Secondary|Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 2.0 Microgram Per Millilitre (µg/mL)|Anti-PSC antibody concentration cut-off value assessed was ≥2.0 µg/mL|Prior to and one month post booster vaccination (at study Months 0 and 1 – booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.||Subjects|||Number
708087|NCT00129116|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31-day (Day 0-30) follow-up period (during the primary phase)|The Total Vaccinated Cohort included all subjects with study vaccine administered for whom data were available.||Subjects|||Number
708088|NCT00129116|Secondary|Number of Subjects With Solicited General Symptoms|Solicited general symptoms assessed were drowsiness, irritability, loss of appetite and fever (fever is defined as rectal temperature ≥ 38.0 degrees Celsius (°C)).|During the 8-day (Day 0-7) follow-up period (during the primary phase)|The Total Vaccinated Cohort included all subjects with study vaccine administered for whom data were available.||Subjects|||Number
708089|NCT00129116|Secondary|Number of Subjects With Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling.|During the 8-day (Day 0-7) follow-up period (during the primary phase)|The Total Vaccinated Cohort included all subjects with study vaccine administered for whom data were available.||Subjects|||Number
708090|NCT00129116|Secondary|Number of Subjects With Vaccine Response to PT, FHA and PRN|Vaccine response rates are defined as appearance of antibodies in subjects who were initially seronegative (i.e., with concentrations < cut-off value) or at least maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (i.e., with concentrations ≥ cut-off value), taking into consideration the decreasing maternal antibodies.|One month after the third dose (at study Month 3 - primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.||Subjects|||Number
708091|NCT00129116|Secondary|Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3 Antibodies|Seroprotection status is defined as anti-polio 1, 2 and 3 antibody titres ≥ 1:8|One month after the third dose (at study Month 3 - primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.||Subjects|||Number
708092|NCT00129116|Secondary|Number of Seroprotected Subjects for Anti-hepatitis B Antibodies|Seroprotection status is defined as anti-HBs antibody concentrations ≥ 10 mIU/mL|One month after the third dose (at study Month 3 - primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.||Subjects|||Number
708093|NCT00129116|Secondary|Number of Seroprotected Subjects for Anti-diphtheria Antibodies|Seroprotection status is defined as anti-diphtheria antibody concentrations ≥ 0.1 IU/mL|One month after the third dose (at study Month 3 - primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.||Subjects|||Number
708094|NCT00129116|Secondary|Anti-poliovirus Types 1, 2, 3 Antibody Titres|Titres are expressed as geometric mean titres (GMTs)|One month after the third dose (at study Month 3 - primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.||Titers||95% Confidence Interval|Geometric Mean
708095|NCT00129116|Secondary|Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations|Antibody concentrations are expressed as geometric mean concentrations (GMCs) in milli-International Units per millilitre (mIU/mL).|One month after the third dose (at study Month 3 - primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.||mIU/mL||95% Confidence Interval|Geometric Mean
708096|NCT00129116|Secondary|Anti-diphtheria Antibody Concentrations|Antibody concentrations are expressed as geometric mean concentrations (GMCs) in IU/mL.|One month after the third dose (at study Month 3 - primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.||IU/mL||95% Confidence Interval|Geometric Mean
708097|NCT00129116|Secondary|Anti-T Antibody Concentrations|Antibody concentrations are expressed as geometric mean concentrations (GMCs) in International Units per millilitre (IU/mL).|Prior to and one month post booster vaccination (at study Months 0 and 1 – booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.||IU/mL||95% Confidence Interval|Geometric Mean
708098|NCT00129116|Secondary|Number of Subjects With Anti-tetanus Toxoid (Anti-T) Antibody Concentration Equal to or Above 0.1 International Units Per Millilitre (IU/mL).|Anti-tetanus toxoid antibody concentration cut-off value assessed was ≥ 0.1 IU/mL|Prior to and one month post booster vaccination (at study Months 0 and 1 – booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.||Subjects|||Number
708099|NCT00129116|Secondary|Anti-PSY Antibody Concentrations|Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.|Prior to and one month post booster vaccination (at study Months 0 and 1 – booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.||µg/mL||95% Confidence Interval|Geometric Mean
708100|NCT00129116|Secondary|Anti-PSC Antibody Concentrations|Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.|Prior to and one month post booster vaccination (at study Months 0 and 1 – booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.||µg/mL||95% Confidence Interval|Geometric Mean
708275|NCT00124176|Primary|Duration of Continuous Therapy|standard intention to treat (ITT) analysis|During hospitalization|||Hours||Inter-Quartile Range|Median
708102|NCT00129116|Secondary|Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL)|Anti-PSC antibody concentration cut-off value assessed was ≥0.30 µg/mL|Prior to and one month post booster vaccination (at study Months 0 and 1 – booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.||Subjects|||Number
708103|NCT00129116|Secondary|rSBA-MenY Antibody Titres|Titres are expressed as geometric mean titres (GMTs)|Prior to and one month post booster vaccination (at study Months 0 and 1 – booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.||Titres||95% Confidence Interval|Geometric Mean
708104|NCT00129116|Secondary|rSBA-MenC Antibody Titres|Titres are expressed as geometric mean titres (GMTs)|Prior to and one month post booster vaccination (at study Months 0 and 1 – booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.||Titers||95% Confidence Interval|Geometric Mean
708105|NCT00129116|Secondary|Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:128|rSBA-MenY antibody titre cut-off value assessed was ≥1:128|Prior to and one month post booster vaccination (at study Months 0 and 1 – booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.||Subjects|||Number
708106|NCT00129116|Secondary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:128|rSBA-MenC antibody titre cut-off value assessed was ≥1:128|Prior to and one month post booster vaccination (at study Months 0 and 1 – booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.||Subjects|||Number
708107|NCT00129116|Secondary|Anti-PRP Antibody Concentrations|Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.|Prior to and one month post booster vaccination (at study Months 0 and 1 – booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.||µg/mL||95% Confidence Interval|Geometric Mean
708108|NCT00129116|Secondary|Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Millilitre (µg/mL).|Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 0.15 microgram per millilitre (µg/mL)|Prior to and one month post booster vaccination (at study Months 0 and 1 – booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.||Subjects|||Number
708109|NCT00129116|Secondary|Number of Subjects With Anti-FHA, Anti-PRN and Anti-PT Antibody Concentration Equal to or Above 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units Per Millilitre (EL.U/mL)|Anti-FHA, anti-PRN and anti-PT antibody concentration cut-off value assessed was ≥ 5 ELISA units per millilitre.|Prior to the first dose and one month after the third dose (at study Months 0 and 3 – primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.||Subjects|||Number
708110|NCT00129116|Secondary|Number of Seroprotected Subjects for Anti-tetanus Antibodies|Seroprotection status is defined as anti-tetanus toxoid antibody concentration ≥ 0.1 International Units per millilitre (IU/mL)|Prior to the first dose and one month after the third dose (at study Months 0 and 3 – primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.||Subjects|||Number
708111|NCT00129116|Secondary|Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN), Anti-pertussis Toxoid (Anti-PT) Antibody Concentrations|Antibody concentrations are expressed as geometric mean concentrations (GMCs) in Enzyme-Linked Immunosorbent Assay (ELISA) Units per millilitre.|Prior to the first dose and one month after the third dose (at study Months 0 and 3 – primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.||EL.U/mL||95% Confidence Interval|Least Squares Mean
708112|NCT00129116|Secondary|Anti-tetanus Antibody Concentrations|Antibody concentrations are expressed as geometric mean concentrations (GMCs) in International Units per millilitre (IU/mL).|Prior to the first dose and one month after the third dose (at study Months 0 and 3 – primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.||IU/mL||95% Confidence Interval|Geometric Mean
708113|NCT00129116|Secondary|Anti-PSY Antibody Concentrations|Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.|Prior to the first dose and one month after the third dose (at study Months 0 and 3 – primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.||µg/mL||95% Confidence Interval|Geometric Mean
708114|NCT00129116|Secondary|Anti-PSC Antibody Concentrations|Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.|Prior to the first dose and one month after the third dose (at study Months 0 and 3 – primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.||µg/mL||95% Confidence Interval|Geometric Mean
708276|NCT00129727|Secondary|Toxicity|Per CTCAE (Common Toxicity Criteria for Adverse Events) number of participants who experienced toxicity on the study|60 months|||Participants|||Number
708277|NCT00129727|Secondary|Response Rate (RECIST-1)|To estimate the objective response rate of carboplatin, paclitaxel, and bevacizumab. Evaluate toxicity.|5 years|||Percentage of Participants||95% Confidence Interval|Number
708115|NCT00129116|Secondary|Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL)|Anti-PSY antibody concentration cut-off value assessed was ≥0.30 µg/mL|Prior to the first dose and one month after the third dose (at study Months 0 and 3 – primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.||Subjects|||Number
708116|NCT00129116|Secondary|Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL)|Anti-PSC antibody concentration cut-off value assessed was ≥0.30 µg/mL|Prior to the first dose and one month after the third dose (at study Months 0 and 3 – primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.||Subjects|||Number
708117|NCT00129116|Secondary|Anti-PRP Antibody Concentrations|Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.|Prior to the first dose and one month after the third dose (at study Months 0 and 3 – primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.||µg/mL||95% Confidence Interval|Geometric Mean
708118|NCT00129116|Secondary|Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Millilitre (µg/mL).|Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 0.15 microgram per millilitre (µg/mL)|Prior to the first dose and one month after the third dose (at study Months 0 and 3 – primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.||Subjects|||Number
708119|NCT00129116|Secondary|rSBA-MenY Antibody Titres|Titres are expressed as geometric mean titres (GMTs)|Prior to the first dose and one month after the third dose (at study Months 0 and 3 – primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.||Titers||95% Confidence Interval|Geometric Mean
708120|NCT00129116|Secondary|rSBA-MenC Antibody Titres|Titres are expressed as geometric mean titres (GMTs)|Prior to the first dose and one month after the third dose (at study Months 0 and 3 – primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.||Titers||95% Confidence Interval|Geometric Mean
708121|NCT00129116|Secondary|Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8|rSBA-MenY antibody titre cut-off value assessed was ≥1:8|Prior to the booster vaccination (at study Month 0 – booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.||Subjects|||Number
708122|NCT00129116|Secondary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8|rSBA-MenC antibody titre cut-off value assessed was ≥1:8|Prior to the booster vaccination (at study Month 0 – booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.||Subjects|||Number
708123|NCT00129116|Secondary|Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL).|Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 1 microgram per millilitre (µg/mL)|Prior to the booster vaccination (at study Month 0 – booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.||Subjects|||Number
708124|NCT00129116|Secondary|Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL).|Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 1 microgram per millilitre (µg/mL)|Before the administration of the first dose (at pre-vaccination = study Month 0 – primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.||Subjects|||Number
708125|NCT00129116|Secondary|Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8|rSBA-MenY antibody titre cut-off value assessed was ≥1:8|Before the administration of the first dose (at pre-vaccination = study Month 0 – primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.||Subjects|||Number
708126|NCT00129116|Secondary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8|rSBA-MenC antibody titre cut-off value assessed was ≥1:8|Before the administration of the first dose (at pre-vaccination = study Month 0 – primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.||Subjects|||Number
708127|NCT00129116|Primary|Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8|rSBA-MenY antibody titre cut-off value assessed was ≥1:8|One month after the booster vaccination (at study Month 1 – booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.||Subjects|||Number
708278|NCT00129727|Primary|PFS|Progression Free Survival: To examine the toxicity, estimate the objective response rate, and progression free survival measured in months of carboplatin, paclitaxel, and bevacizumab followed by single agent bevacizumab as consolidation for advanced mullerian cancer|Median PFS in months - up to 5 years|||Months||95% Confidence Interval|Median
708128|NCT00129116|Primary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8|rSBA-MenC antibody titre cut-off value assessed was ≥1:8|One month after the booster vaccination (at study Month 1 – booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.||Subjects|||Number
708129|NCT00129116|Primary|Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL).|Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 1 microgram per millilitre (µg/mL)|One month after the booster vaccination (at study Month 1 – booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.||Subjects|||Number
708130|NCT00129116|Primary|Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8|rSBA-MenY antibody titre cut-off value assessed was ≥1:8|One month after dose 3 (at study Month 3 - primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.||Subjects|||Number
708131|NCT00129116|Primary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8|rSBA-MenC antibody titre cut-off value assessed was ≥1:8|One month after dose 3 (at study Month 3 - primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.||Subjects|||Number
708132|NCT00129116|Primary|Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL).|Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 1 microgram per millilitre (µg/mL)|One month after dose 3 (at study Month 3 - primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.||Subjects|||Number
708133|NCT00129129|Secondary|Number of Subjects Reporting Large Swelling Reactions of the Injected Limb(s)|Large injection site reactions were defined as either swelling with a diameter of > 30 mm or a > 30 mm increase in the circumference of the mid-thigh when compared to the baseline (pre-vaccination) measurement, or any diffuse swelling that interfered with or prevented everyday activities (for example, active playing, eating, sleeping).|Within 4 days (Day 0-3) and within 8 days (Day 0-7) following the fourth dose|The Fourth Dose Total Vaccinated cohort included all vaccinated subjects during the fourth dose phase.||Subjects|||Number
708134|NCT00129129|Secondary|Number of Subjects Reporting Emergency Room (ER) Visits or Physicians Office Visits Related or Not to Common Illnesses|Emergency room (ER) visits or physicians office visits assessed were those unrelated to well-child care, vaccination, injury or common acute illnesses such as upper respiratory tract infections, otitis media, pharyngitis, gastroenteritis. This Outcome Measure only concerns the MenHibrix and ActHIB groups.|From receipt of the fourth dose (at Month 10-13) through the end of the 6-month safety follow-up|The Fourth Dose Total Vaccinated cohort included all vaccinated subjects during the fourth dose phase.||Subjects|||Number
708135|NCT00129129|Secondary|Number of Subjects Reporting Rash|An episode of rash was defined as an episode of hives, idiopathic thrombocytopenic purpura, petechiae.|From receipt of the fourth dose (at Month 10-13) through the end of the 6-month safety follow-up|The Fourth Dose Total Vaccinated cohort included all vaccinated subjects during the fourth dose phase.||Subjects|||Number
708136|NCT00129129|Secondary|Number of Subjects Reporting New Onset of Chronic Illness(es)|NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.|From receipt of the fourth dose (at Month 10-13) through the end of the 6-month safety follow-up|The Fourth Dose Total Vaccinated cohort included all vaccinated subjects during the fourth dose phase.||Subjects|||Number
708137|NCT00129129|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|During the entire Primary Phase of the study, from Day 0 up to the end of Primary Phase safety follow-up period (6 months after the last vaccination).|The Fourth Dose Total Vaccinated cohort included all vaccinated subjects during the fourth dose phase.||Subjects|||Number
708138|NCT00129129|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31-day follow-up period following the fourth dose|The Fourth Dose Total Vaccinated cohort included all vaccinated subjects during the fourth dose phase.||Subjects|||Number
708139|NCT00129129|Secondary|Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms|Solicited general symptoms assessed were fever, irritability/fussiness, drowsiness, loss of appetite. “Any”= any report of the specified symptom irrespective of intensity and relationship to vaccination. “Grade 2” for Drowsiness, Irritability/Fussiness & Loss of appetite = interfered with normal activity; “Grade 3” for Drowsiness, Irritability/Fussiness = prevented normal activity; “Grade 3” Loss of appetite = not eating at all; Fever = rectal temperature (T) ≥38.0 degrees Celsius (°C); “Grade 2 or 3” for fever = T >39.0°C; “Grade 3” for fever = T >40.0°C|Within 8 days (Day 0-7) after fourth dose vaccination|The Fourth Dose Total Vaccinated cohort included all vaccinated subjects during the fourth dose phase.||Subjects|||Number
708169|NCT00129129|Secondary|Number of Subjects Reporting New Onset of Chronic Illness(es) (NOCIs)|NOCIs include autoimmune disorders, asthma, type I diabetes, allergies. This Outcome Measure only concerns the MenHibrix and ActHIB groups .|From Day 0 following Dose 1 throughout the study up to the day preceding the administration of the fourth dose of vaccine|The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.||Subjects|||Number
708140|NCT00129129|Secondary|Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms|Solicited general symptoms assessed were fever, irritability/fussiness, drowsiness, loss of appetite. “Any”= any report of the specified symptom irrespective of intensity and relationship to vaccination. “Grade 2” for Drowsiness, Irritability/Fussiness & Loss of appetite = interfered with normal activity; “Grade 3” for Drowsiness, Irritability/Fussiness = prevented normal activity; “Grade 3” Loss of appetite = not eating at all; Fever = rectal temperature (T) ≥38.0 degrees Celsius (°C); “Grade 2 or 3” for fever = T >39.0°C; “Grade 3” for fever = T >40.0°C|Within 4 days (Day 0-3) after fourth dose vaccination|The Fourth Dose Total Vaccinated cohort included all vaccinated subjects during the fourth dose phase.||Subjects|||Number
708141|NCT00129129|Secondary|Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms|Solicited symptoms assessed were pain, redness, swelling at the injection site and increase in limb circumference. “Any”= any report of the specified symptom irrespective of intensity grade; “Grade 2 pain” = cried/protested on touch; “Grade 3 pain” = cried when limb was moved/spontaneously painful; “Grade 2 or 3” redness/swelling = redness/swelling >10 millimeters (mm); “Grade 3” redness/swelling = redness/swelling >30 mm; “Grade 2” limb circumference (LC) = LC >20 mm; “Grade 3” LC = LC >40 mm|Within 8 days (Day 0-7) after fourth dose vaccination|The Fourth Dose Total Vaccinated cohort included all vaccinated subjects during the fourth dose phase.||Subjects|||Number
708142|NCT00129129|Secondary|Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms|Solicited symptoms assessed were pain, redness, swelling at the injection site and increase in limb circumference. “Any”= any report of the specified symptom irrespective of intensity grade; “Grade 2 pain” = cried/protested on touch; “Grade 3 pain” = cried when limb was moved/spontaneously painful; “Grade 2 or 3” redness/swelling = redness/swelling >10 millimeters (mm); “Grade 3” redness/swelling = redness/swelling >30 mm; “Grade 2” limb circumference (LC) = LC >20 mm; “Grade 3” LC = LC >40 mm|Within 4 days (Day 0-3) after fourth dose vaccination|The Fourth Dose Total Vaccinated cohort included all vaccinated subjects during the fourth dose phase||Subjects|||Number
708143|NCT00129129|Secondary|Anti-tetanus Antibody Concentrations|Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as international units per milliliter (IU/mL).|Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.||IU/mL||95% Confidence Interval|Geometric Mean
708144|NCT00129129|Secondary|Number of Subjects With Anti-tetanus Antibody Concentration Equal to or Above 0.1 International Units Per Milliliter (IU/mL)||Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.||Subjects|||Number
708145|NCT00129129|Secondary|Anti-PSY Antibody Concentrations|Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL)|Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.||µg/mL||95% Confidence Interval|Geometric Mean
708146|NCT00129129|Secondary|Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations Equal to or Above the Cut-off Values|Anti-PSY antibody cut-off values assessed were ≥0.3 µg/mL and ≥2.0 µg/mL.|Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.||Subjects|||Number
708147|NCT00129129|Secondary|Anti-PSC Antibody Concentrations|Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL).|Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.||µg/mL||95% Confidence Interval|Geometric Mean
708148|NCT00129129|Secondary|Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Equal to or Above the Cut-off Values|Anti-PSC antibody cut-off values assessed were ≥0.3 µg/mL and ≥2.0 µg/mL.|Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.||Subjects|||Number
708149|NCT00129129|Secondary|hSBA-MenY Antibody Titers|Titers are presented as geometric mean titers (GMTs).|Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.||Titers||95% Confidence Interval|Geometric Mean
708179|NCT00129129|Secondary|Number of Subjects With Anti-poliovirus Types 1, 2 and 3 Antibody Titer ≥ 1:8|This Outcome Measure only concerns the MenHibrix and ActHIB groups .|Prior to and one month after the primary vaccination course (at Day 0 and Month 5)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.||Subjects|||Number
708150|NCT00129129|Secondary|Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Human Complement (hSBA-MenY) Antibody Titers Equal to or Above the Cut-off Values|hSBA-MenY antibody cut-off values assessed were ≥1:4 and ≥1:8.|Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.||Subjects|||Number
708151|NCT00129129|Secondary|hSBA-MenC Antibody Titers|Titers are presented as geometric mean titers (GMTs).|Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.||Titers||95% Confidence Interval|Geometric Mean
708152|NCT00129129|Secondary|Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Human Complement (hSBA-MenC) Antibody Titers Equal to or Above the Cut-off Values|hSBA-MenC antibody cut-off values assessed were ≥1:4 and ≥1:8.|Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.||Subjects|||Number
708153|NCT00129129|Secondary|rSBA-MenY Antibody Titers|Titers are presented as geometric mean titers (GMTs).|Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.||Titers||95% Confidence Interval|Geometric Mean
708154|NCT00129129|Secondary|Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers Equal to or Above the Cut-off Values|rSBA-MenY antibody cut-off values assesse were ≥1:8 and ≥1:128.|Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.||Subjects|||Number
708155|NCT00129129|Secondary|rSBA-MenC Antibody Titers|Titers are presented as geometric mean titers (GMTs).|Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.||Titers||95% Confidence Interval|Geometric Mean
708156|NCT00129129|Secondary|Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers Equal to or Above the Cut-off Values|rSBA-MenC antibody cut-off values assessed were ≥1:8 and ≥1:128|Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.||Subjects|||Number
708157|NCT00129129|Secondary|Anti-PRP Antibody Concentrations|Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL)|Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.||µg/mL||95% Confidence Interval|Geometric Mean
708158|NCT00129129|Secondary|Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations Equal to or Above the Cut-off Values|Anti-PRP antibody cut-off values assessed were ≥0.15 µg/mL and ≥1.0 µg/mL.|Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.||Subjects|||Number
708159|NCT00129129|Secondary|Concentration of Antibodies Against Streptococcus Pneumonia Serotypes|"Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL).
Vaccine pneumococcal serotypes included serotypes 4, 6B, 9V, 14, 18C, 19F, 23F."|One month post fourth dose vaccination (at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.||µg/mL||95% Confidence Interval|Geometric Mean
708160|NCT00129129|Secondary|Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.5 Microgram Per Milliliter (µg/mL)|"Streptococcus pneumoniae antibody cut-off values assessed was ≥0.5 µg/mL for the 7 serotypes in Prevnar vaccine.
Vaccine pneumococcal serotypes included serotypes 4, 6B, 9V, 14, 18C, 19F, 23F."|One month after fourth dose vaccination (at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.||Subjects|||Number
708161|NCT00129129|Secondary|Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.2 Microgram Per Milliliter (µg/mL)|"Streptococcus pneumoniae antibody cut-off values assessed was ≥0.2 µg/mL for the 7 serotypes in Prevnar vaccine.
Vaccine pneumococcal serotypes included serotypes 4, 6B, 9V, 14, 18C, 19F, 23F."|One month after fourth dose vaccination (at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.||Subjects|||Number
708162|NCT00129129|Secondary|Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.05 Microgram Per Milliliter (µg/mL)|"Streptococcus pneumoniae antibody cut-off values assessed was ≥0.05 µg/mL for the 7 serotypes in Prevnar vaccine.
Vaccine pneumococcal serotypes included serotypes 4, 6B, 9V, 14, 18C, 19F, 23F."|One month after fourth dose vaccination (at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.||Subjects|||Number
708163|NCT00129129|Secondary|Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Human Complement (hSBA-MenC and Y)|"Fourth dose responses to hSBA-MenC and hSBA-MenY were also assessed using a second definition (Definition 2):
Post-fourth dose hSBA antibody titers ≥1:16 in subjects seronegative at the pre-fourth dose time point (hSBA antibody titers < 1:8),
At least (i.e., greater than or equal to) a 4-fold rise in hSBA antibody titers in subjects with pre-fourth dose antibody titers ≥1:4 but < 1: 8,
At least (i.e., greater than or equal to) a 2-fold rise in hSBA antibody titers in subjects with pre-fourth dose antibody titers ≥1:8."|One month post fourth dose vaccination (at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.||Subjects|||Number
708164|NCT00129129|Secondary|Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Human Complement (hSBA-MenC and Y)|"Fourth dose responses to hSBA-MenC and hSBA-MenY were defined as follows (Definition 1):
Initially seronegative subjects (pre-fourth dose antibody titer below cut-off: < 1:8) should have an antibody titer at least four-fold higher than the cut-off, one month after the fourth dose (post-fourth dose antibody titer ≥1:16),
Initially seropositive subjects (pre-fourth dose antibody titer above cut-off: ≥1:8) should have an antibody titer at least four-fold higher than the pre-fourth dose antibody titer, one month after the fourth dose."|One month post fourth dose vaccination (at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.||Subjects|||Number
708165|NCT00129129|Secondary|Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC and Y)|"Fourth dose responses to rSBA-MenC and rSBA-MenY were also assessed using a second definition (Definition 2):
Post-fourth dose rSBA antibody titers ≥1:32 in subjects seronegative at the pre-fourth dose time point (rSBA antibody titers < 1:8),
At least (i.e., greater than or equal to) a 4-fold rise in rSBA antibody titers in subjects with pre-fourth dose antibody titers ≥1:8 but < 1:128,
At least (i.e., greater than or equal to) a 2-fold rise in rSBA antibody titers in subjects with pre-fourth dose antibody titers ≥1:128."|One month post fourth dose vaccination (at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.||Subjects|||Number
708166|NCT00129129|Secondary|Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC and Y)|"Fourth dose responses to rSBA-MenC and rSBA-MenY were defined as follows (Definition 1):
Initially seronegative subjects (pre-fourth dose antibody titer below cut-off: < 1:8) should have an antibody titer at least four-fold higher than the cut-off, one month after fourth dose (post-fourth dose antibody titer ≥1:32),
Initially seropositive subjects (pre-fourth dose antibody titer above cut-off: ≥1:8) should have an antibody titer at least four-fold higher than the pre-fourth dose antibody titer, one month after fourth dose."|One month post fourth dose vaccination (at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.||Subjects|||Number
708167|NCT00129129|Secondary|Number of Subjects Reporting Emergency Room (ER) Visits or Visits to Physicians’ Office, Related or Not to Common Illnesses|Emergency room (ER) visits or physicians office visits assessed were those unrelated to well-child care, vaccination, injury or common acute illnesses such as upper respiratory tract infections, otitis media, pharyngitis, gastroenteritis. This Outcome Measure only concerns the MenHibrix and ActHIB groups.|From Day 0 following Dose 1 throughout the study up to the day preceding the administration of the fourth dose of vaccine.|The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.||Subjects|||Number
708168|NCT00129129|Secondary|Number of Subjects Reporting Rash|An episode of rash was defined as an episode of hives, idiopathic thrombocytopenic purpura, petechiae. This Outcome Measure only concerns the MenHibrix and ActHIB groups .|From Day 0 following Dose 1 throughout the study up to the day preceding the administration of the fourth dose of vaccine.|The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.||Subjects|||Number
708718|NCT00143507|Primary|Primary Composite Endpoint|First event among cardiovascular death, hospitalisation for acute myocardial infarction (fatal or not), or hospitalisation for new onset or worsening heart failure (fatal or not).|From the date of randomisation to the date of the first occurrence of the first event, up to 3 years.|||participants|||Number
708170|NCT00129129|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. This Outcome Measure only concerns the MenHibrix and ActHIB groups .|From Day 0 following Dose 1 throughout the study up to the day preceding the administration of the fourth dose of vaccine.|The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.||Subjects|||Number
708171|NCT00129129|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|During the entire Primary Phase of the study, from Day 0 up to the end of Primary Phase safety follow-up period (6 months after the last vaccination).|The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.||Subjects|||Number
708172|NCT00129129|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|From Dose 1 (at Day 0) through Day 30 following the last vaccine dose administered (Day 30 post Month 4 vaccination for MenHibrix and ActHIB groups, Day 30 post Month 1 for Menomune Group).|The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.||Subjects|||Number
708173|NCT00129129|Secondary|Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms|Solicited general symptoms were fever, irritability/fussiness, drowsiness, and loss of appetite. “Any” = any report of the specified symptom irrespective of intensity grade and relationship to vaccination. “Grade 2” for Drowsiness, Irritability/Fussiness and Loss of appetite = symptom that interfered with normal activity; “Grade 3” for Drowsiness and Irritability/Fussiness = symptom that prevented normal activity; “Grade 3” Loss of appetite = not eating at all. Fever = rectal temperature ≥ 38.0 degrees Celsius (°C); “Grade 2 or 3” fever = rectal temperature higher than (>) 39°C; “Grade 3” fever = rectal temperature > 40°C. This Outcome Measure only concerns the MenHibrix and ActHIB groups|Within 8 days (Day 0-7) after the 3-dose primary vaccination|The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.||Subjects|||Number
708174|NCT00129129|Secondary|Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms|Solicited general symptoms were fever, irritability/fussiness, drowsiness, and loss of appetite. “Any” = any report of the specified symptom irrespective of intensity grade and relationship to vaccination. “Grade 2” for Drowsiness, Irritability/Fussiness and Loss of appetite = symptom that interfered with normal activity; “Grade 3” for Drowsiness and Irritability/Fussiness = symptom that prevented normal activity; “Grade 3” Loss of appetite = not eating at all. Fever = rectal temperature ≥ 38.0 degrees Celsius (°C); “Grade 2 or 3” fever = rectal temperature higher than (>) 39°C; “Grade 3” fever = rectal temperature > 40°C. This Outcome Measure only concerns the MenHibrix and ActHIB groups .|Within 4 days (Day 0-3) after the 3-dose primary vaccination|The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.||Subjects|||Number
708175|NCT00129129|Secondary|Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms|Solicited local symptoms were pain, redness and swelling at injection site. “Any” = any report of the specified symptom irrespective of intensity grade; “Grade 2 pain” = cried/protested on touch; “Grade 3 pain” = cried when limb was moved/spontaneously painful; “Grade 2 or 3” redness/swelling = redness/swelling larger than (>) 10 millimeters (mm); “Grade 3” redness/swelling = redness/swelling > 30 mm. This Outcome Measure only concerns the MenHibrix and ActHIB groups .|Within 8 days (Day 0-7) after the 3-dose primary vaccination|The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.||Subjects|||Number
708176|NCT00129129|Secondary|Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms|Solicited local symptoms were pain, redness and swelling at injection site. “Any” = any report of the specified symptom irrespective of intensity grade; “Grade 2 pain” = cried/protested on touch; “Grade 3 pain” = cried when limb was moved/spontaneously painful; “Grade 2 or 3” redness/swelling = redness/swelling larger than (>) 10 millimeters (mm); “Grade 3” redness/swelling = redness/swelling > 30 mm. This Outcome Measure only concerns the MenHibrix and ActHIB groups .|Within 4 days (Day 0-3) after the 3-dose primary vaccination|The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.||Subjects|||Number
708177|NCT00129129|Secondary|Number of Subjects With Vaccine Response to PT, FHA and PRN|Vaccine response to PT/FHA/PRN was defined as, for initially seronegative subjects, antibody concentration ≥ 5 EL.U/mL one month post-primary vaccination course, and, for initially seropositive subjects, antibody concentration one month post-primary vaccination course ≥ 1-fold the pre-vaccination antibody concentration. A seronegative/seronegative subject was defined as a subject with antibody concentration </≥ 5 EL.U/mL for anti-PT/FHA/PRN prior to vaccination. This Outcome Measure only concerns the MenHibrix and ActHIB groups .|One month after the 3-dose primary vaccination course (at Month 5)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.||Subjects|||Number
708178|NCT00129129|Secondary|Anti-poliovirus Types 1, 2 and 3 Antibody Titers|Titers are presented as geometric mean titers (GMTs). This Outcome Measure only concerns the MenHibrix and ActHIB groups .|Prior to and one month after the primary vaccination course (at Day 0 and Month 5)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.||Titers||95% Confidence Interval|Geometric Mean
708180|NCT00129129|Secondary|Anti PT, Anti-FHA and Anti-PRN Antibody Concentrations|Concentrations of antibodies are presented as GMCs expressed as EL.U/mL. Results for one month after the 3-dose primary vaccination course (at Month 5) are presented under the Primary Outcome Measures section. This Outcome Measure only concerns the MenHibrix and ActHIB groups .|Prior to the primary vaccination course (at Day 0)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.||EL.U/mL||95% Confidence Interval|Geometric Mean
708181|NCT00129129|Secondary|Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentration ≥ 5.0 EL.U/mL|This Outcome Measure only concerns the MenHibrix and ActHIB groups .|Prior to and one month after the primary vaccination course (at Day 0 and Month 5)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.||Subjects|||Number
708182|NCT00129129|Secondary|Anti-hepatitis-B Surface Antigen (Anti-HBs) Antibody Concentrations|Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as milli-international units per milliliter (mIU/mL). This Outcome Measure only concerns the MenHibrix and ActHIB groups .|Prior to and one month after the primary vaccination course (at Day 0 and Month 5)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.||mIU/mL||95% Confidence Interval|Geometric Mean
708183|NCT00129129|Secondary|Number of Subjects With Anti-hepatitis-B Surface Antigen (Anti-HBs) Antibody Concentration ≥ 10.0 Milli-international Units Per Milliliter (mIU/mL)|This Outcome Measure only concerns the MenHibrix and ActHIB groups .|Prior to and one month after the primary vaccination course (at Day 0 and Month 5)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.||Subjects|||Number
708184|NCT00129129|Secondary|Anti-diphtheria and Anti-tetanus Antibody Concentrations|Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as international units per milliliter (IU/mL). This Outcome Measure only concerns the MenHibrix and ActHIB groups .|Prior to and one month after the primary vaccination course (at Day 0 and Month 5)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.||IU/mL||95% Confidence Interval|Geometric Mean
708185|NCT00129129|Secondary|Number of Subjects With Anti-diphtheria and Anti-tetanus Antibody Concentration ≥ 0.1 International Units Per Milliliter (IU/mL)|The anti-diphtheria and anti-tetanus antibody cut-off value for this outcome was ≥ 0.1 IU/mL. This Outcome Measure only concerns the MenHibrix and ActHIB groups.|Prior to and one month after the primary vaccination course (at Day 0 and Month 5)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.||Subjects|||Number
708186|NCT00129129|Secondary|Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off|The Streptococcus pneumoniae antibody cut-off value for this outcome was 0.5 µg/mL for the 7 serotypes in Prevnar vaccine. Prevnar vaccine pneumococcal serotypes included the serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. This Outcome Measure only concerns the MenHibrix and ActHIB groups .|Prior to and one month after the primary vaccination course (at Day 0 and Month 5)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.||Subjects|||Number
708187|NCT00129129|Secondary|Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off|The Streptococcus pneumoniae antibody cut-off value for this outcome was 0.2 µg/mL for the 7 serotypes in Prevnar vaccine. Prevnar vaccine pneumococcal serotypes included the serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. This Outcome Measure only concerns the MenHibrix and ActHIB groups|Prior to and one month after the primary vaccination course (at Day 0 and Month 5)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.||Subjects|||Number
708188|NCT00129129|Secondary|Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off|The Streptococcus pneumoniae antibody cut-off value for this outcome was 0.05 µg/mL for the 7 serotypes in Prevnar vaccine. Prevnar vaccine pneumococcal serotypes included the serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. This Outcome Measure only concerns the MenHibrix and ActHIB groups .|Prior to and one month after the primary vaccination course (at Day 0 and Month 5)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.||Subjects|||Number
708218|NCT00129220|Secondary|Change From Baseline to 6 Week Endpoint in Young Mania Rating Scale (YMRS)|The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.|Baseline, 6 weeks|Participants in the Full Analysis Set: participants who had baseline and post-baseline measurement.||units on a scale||Standard Deviation|Mean
708189|NCT00129129|Secondary|Anti-PRP Antibody Concentrations|Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL). This Outcome Measure only concerns the MenHibrix and ActHIB groups .|Prior to and one month after the primary vaccination course (at Day 0 and Month 5)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.||µg/mL||95% Confidence Interval|Geometric Mean
708190|NCT00129129|Secondary|Number of Subjects With Anti-PRP Antibody Concentrations ≥ the Cut-off Values|Anti-PRP antibody cut-off values for this outcome were 0.15 µg/mL and 1.0 µg/mL. This Outcome Measure only concerns the MenHibrix and ActHIB groups .|Prior to and one month after the primary vaccination course (at Day 0 and Month 5)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.||Subjects|||Number
708191|NCT00129129|Primary|Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentration Equal to or Above (≥) Cut-off Value|The anti-PRP antibody cut-off value used for this outcome was 1.0 microgram per milliliter (µg/mL). This Outcome Measure only concerns the MenHibrix and ActHIB/ActHIB groups .|One month after the fourth dose (at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies 1 month (31 to 48 days) after the administration of the fourth dose.||Subjects|||Number
708192|NCT00129129|Primary|Number of Subjects Reporting Any Grade 3 Symptoms|“Symptoms” were defined as solicited local and general symptoms and unsolicited adverse events (AEs). A “Grade 3” symptom was defined as any symptom that prevented normal everyday activity. “Any” was defined as an occurrence of any specified symptom regardless of intensity grade. This Outcome Measure only concerns the MenHibrix and ActHIB groups .|During the 4-day follow-up period after each primary vaccine dose|The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.||Subjects|||Number
708193|NCT00129129|Primary|Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations|Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed in Enzyme-Linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL). This Outcome Measure only concerns the MenHibrix and ActHIB groups .|One month after the 3-dose primary vaccination course (at Month 5)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.||EL.U/mL||95% Confidence Interval|Geometric Mean
708194|NCT00129129|Primary|Concentration of Antibodies Against Streptococcus Pneumoniae Serotypes|Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL). Vaccine pneumococcal serotypes included serotypes 4, 6B, 9V, 14, 18C, 19F, 23F. This Outcome Measure only concerns the MenHibrix and ActHIB groups .|One month after the 3-dose primary vaccination course (at Month 5)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.||µg/mL||95% Confidence Interval|Geometric Mean
708195|NCT00129129|Primary|Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentration Equal to or Above (≥) Cut-off Value.|The anti-PRP antibody cut-off value used for this outcome was 1.0 microgram per milliliter (µg/mL). This Outcome Measure only concerns the MenHibrix and ActHIB groups .|One month after the 3-dose primary vaccination course (at Month 5)|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures, with no elimination criteria) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase||Subjects|||Number
708196|NCT00129129|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject . This Outcome Measure only concerns subjects in the Menomune Group.|During the 31-day follow-up period after vaccination with Menomune vaccine at Day 0|The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.||Subjects|||Number
708197|NCT00129129|Secondary|Number of Subjects Reporting Rash|An episode of rash was defined as an episode of hives, idiopathic thrombocytopenic purpura, petechiae. This Outcome Measure only concerns subjects in the Menomune Group.|During the 31-day follow-up period after vaccination with Menomune vaccine at Day 0|The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.||Subjects|||Number
708198|NCT00129129|Secondary|Number of Subjects Reporting Medically Attended Visits|A medically attended visit was defined as an hospitalization, an emergency room visit or a visit to or from medical personnel. This Outcome Measure only concerns subjects in the Menomune Group.|During the 31-day follow-up period after vaccination with Menomune vaccine at Day 0|The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.||Subjects|||Number
708219|NCT00129220|Primary|Change From Baseline to 3 Week Endpoint in Young Mania Rating Scale (YMRS) Total Score|The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.|Baseline, 3 weeks|Participants in the Full Analysis Set: participants who had baseline and post-baseline measurement.||units on a scale||Standard Deviation|Mean
708199|NCT00129129|Secondary|Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations|Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL)|Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.||µg/mL||95% Confidence Interval|Geometric Mean
708200|NCT00129129|Secondary|Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations Equal to or Above ≥ the Cut-off Values|Anti-PSY antibody cut-off values for this outcome were 0.3 µg/mL and 2.0 µg/mL.|Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.||Subjects|||Number
708201|NCT00129129|Secondary|Anti-polysaccharide C (Anti-PSC) Antibody Concentrations|Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL).|Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.||µg/mL||95% Confidence Interval|Geometric Mean
708202|NCT00129129|Secondary|Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Above ≥ the Cut-off Values|Anti-PSC antibody cut-off values for this outcome were 0.3 µg/mL and 2.0 µg/mL.|Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.||Subjects|||Number
708203|NCT00129129|Secondary|Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Human Complement (hSBA-MenC) Antibody Titers ≥ 1:4|A composite outcome variable was formulated as follows for this immunogenicity analysis outcome: hSBA-Men titers ≥ 1:4 for subjects with post-vaccination rSBA-Men antibody titers ≥ 1:8 and lower than (<) 1:128.|One month after the primary vaccination course (at Month 5 for the MenHibrix and ActHIB groups)/one month after vaccination (at Month 1 for the Menomune Group)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.||Subjects|||Number
708204|NCT00129129|Secondary|Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Human Complement (hSBA-MenC) Antibody Titers ≥ 1:4|A composite outcome variable was formulated as follows for this immunogenicity analysis outcome: hSBA-Men titers ≥ 1:4 for subjects with post-vaccination rSBA-Men antibody titers ≥ 1:8 and lower than (<) 1:128.|One month after the primary vaccination course (at Month 5 for the MenHibrix and ActHIB groups)/one month after vaccination (at Month 1 for the Menomune Group)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.||Subjects|||Number
708205|NCT00129129|Secondary|Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers|Titers are presented as geometric mean titers (GMTs).|Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.||Titers||95% Confidence Interval|Geometric Mean
708206|NCT00129129|Secondary|Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers ≥ the Cut-off Values|rSBA-MenY antibody cut-off values for this outcome measure were 1:8 and 1:128.|Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.||Subjects|||Number
708207|NCT00129129|Secondary|Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers|Titers are presented as geometric mean titers (GMTs).|Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.||Titers||95% Confidence Interval|Geometric Mean
708220|NCT00129246|Primary|Weight Gain|Weight gain for for the entire sample in pounds at 6 weeks.|Week 6|Per protocol analysis||lbs||Standard Deviation|Mean
708208|NCT00129129|Secondary|Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers ≥ the Cut-off Values|rSBA-MenC antibody cut-off values for this outcome were 1:8 and 1:128.|Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.||Subjects|||Number
708209|NCT00129220|Secondary|Maximum Change From Baseline During 6-Week Period in Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Total Score|Drug Induced Extra-Pyramidal Symptoms Scale (DIEPSS) is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the sum of the 8 item scores, for a total range of 0 (normal) to 32 (severe).|Baseline to 6 weeks|Participants in the Safety Analysis Set (participants who had baseline and post-baseline measurements). Participants were included in the treatment group for which they actually received treatment.||units on a scale||Standard Deviation|Mean
708210|NCT00129220|Secondary|Percentage of Participants Who Switched to Syndromic Depression|Switch to syndromic depression was operationally defined by meeting both of the following criteria: At baseline, the symptoms did not meet the criteria for a mixed episode based on the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR). The critiera were met for a Major Depressive Episode (MDE), at any point after randomization, based on DSM-IV-TR. Rather than the 2-week period required for an MDE in the DSM-IV-TR, the patient had to meet the criteria of an MDE for at least 7 consecutive days (during Weeks 1 through 6).|3 weeks, 6 weeks|Participants in the Full Analysis Set (participants who had baseline and post-baseline measurement) who had manic (not mixed) episode at baseline.||percentage of participants|||Number
708211|NCT00129220|Secondary|Change From Baseline to 3 Week and 6 Week Endpoints in the Positive Subscore of Positive and Negative Syndrome Scale (PANSS)|Assesses positive symptoms associated with schizophrenia. 7 items make up the Positive scale (ex. delusions, conceptual disorganization, and hallucinatory behavior). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total Positive Subscale scores range from 7 to 49. For this study, the score was converted to 0 to 6 for each item range; hence, the total positive subscale score ranges from 0 to 42.|Baseline, 3 weeks, 6 weeks|Participants in the Full Analysis Set: participants who had baseline and post-baseline measurement.||units on a scale||Standard Deviation|Mean
708212|NCT00129220|Secondary|Percentage of Participants Who Switched to Symptomatic Depression|Switch to symptomatic depression was defined as HAMD-17 total score ≥13 at any time in the participants with HAMD-17 total scores ≤7 at baseline. The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).|3 weeks, 6 weeks|Participants in the Full Analysis Set (participants who had baseline and post-baseline measurement) who had HAMD-17 total scores ≤7 at baseline.||percentage of participants|||Number
708213|NCT00129220|Secondary|Remission Rate of Manic Symptoms at 3 Weeks and 6 Weeks|Participants who had a YMRS total score of 12 or less were considered to be in remission of manic symptoms. YMRS is an 11-item scale that measures severity of manic episodes; total score ranges from 0 (normal) to 60 (severe). Remission Rate (percent) = number of patients meeting remission criteria divided by number of patients in treatment arm, multiplied by 100.|3 weeks, 6 weeks|Participants in the Full Analysis Set: participants who had baseline and post-baseline measurement.||percentage of participants|||Number
708214|NCT00129220|Secondary|Response Rate of Manic Symptoms at 3 Weeks and 6 Weeks|Participants who had 50 percent or more decrease from the baseline in YMRS total scores were defined as a responder. The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60. Response Rate (percent) = number of patients meeting response criterion for manic symptom divided by number of patients in treatment arm, multiplied by 100.|Baseline, 3 weeks, 6 weeks|Participants in the Full Analysis Set: participants who had baseline and post-baseline measurement.||percentage of participants|||Number
708215|NCT00129220|Secondary|Change From Baseline to 3 Week and 6 Week Endpoints in Clinical Global Impression - Bipolar Version (CGI-BP) Mania Subscale|A global rating scale for severity of patients adapted to bipolar disorder. Measures severity of the patient's overall severity of manic symptoms on a scale of 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Baseline, 3 weeks, 6 weeks|Participants in the Full Analysis Set: participants who had baseline and post-baseline measurement.||units on a scale||Standard Deviation|Mean
708216|NCT00129220|Secondary|Change From Baseline to 6 Week Endpoint in Clinical Global Impressions - Bipolar Version (CGI-BP), Overall Severity of Illness|A global rating scale for severity of patients adapted to bipolar disorder. Measures severity of the patient's overall severity of overall mood symptoms on a scale of 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Baseline, 6 weeks|Participants in the Full Analysis Set: participants who had baseline and post-baseline measurement.||units on a scale||Standard Deviation|Mean
708217|NCT00129220|Secondary|Remission Rate of Bipolar Disorder (Olanzapine Versus Haloperidol)|Remission of bipolar disorder was defined as completing the 6-week period with meeting the criteria for Young Mania Rating Scale (YMRS) total score of 12 or less and 17-Item Hamilton Depression Rating Scale (HAMD-17) total scores of 7 or less at Week 6. YMRS is an 11-item scale measuring severity of manic episodes; total score ranges = 0 (normal) to 60 (severe). The 17-item HAMD measures depression severity; total score ranges = 0 (normal) to 52 (severe). Remission Rate (percent) = number of patients meeting remission criteria divided by number of patients in treatment arm, multiplied by 100.|6 weeks|Participants in the Full Analysis Set: participants who had baseline and post-baseline measurement.||percentage of participants|||Number
708221|NCT00129246|Secondary|Weight Gain Abstinent Participants|Weight gain (in pounds) for the patients that were continuously abstinent at 6 weeks.|Week 6|Per protocol analysis||lbs||Standard Deviation|Mean
708224|NCT00129259|Secondary|Change in Average Total Insulin Dose Per Body Weight|This measure is computed using the average amount of exogenous insulin taken per day for the 3 days prior to the visit. The average insulin use is divided by the subject's weight in kilograms (kg). The need for lower dose(s) of prescribed exogenous insulin while maintaining optimal control of a subject's diabetes reflects improved management of the underlying disease.|Baseline (Pre-treatment), Month 24|Intent-to-treat with available data||Units of Insulin/kilogram/day (U/kg/day)||Standard Deviation|Mean
708225|NCT00129259|Secondary|Change in HbA1c|Glycosylated hemoglobin (HbA1c) is a measure of the average plasma glucose concentration over prolonged periods of time and measures the level of optimal management of underlying disease. (Normal :< 5.7%; pre-diabetes: 5.7% -6.4%; diabetes: 6.5% or higher).A decline in HbA1c from baseline to month 24 signifies an improvement in diabetic control. The goal of treatment: to maintain the HgA1c level as close to normal as possible without frequent occurrence of hypoglycemia.|Baseline (Pre-treatment), Month 24|Intent-to-treat with available data||Percentage (%)||Standard Deviation|Mean
708226|NCT00129259|Primary|Change in Mean C-peptide Area Under the Curve (AUC) Response to a Mixed Meal Tolerance Test (MMTT)|C-peptide AUC is computed using the trapezoidal rule and dividing by the interval of time from the 4 hour Mixed Meal Tolerance Test (MMTT) where assessments are taken every 30 minutes after initial assessments 15 minutes apart. A higher C-peptide AUC is desirable as detectable C-peptide is a marker for the ability of the pancreas to produce insulin in response to a MMTT. The baseline data was used to adjust for the C-peptide AUC primary endpoint at 24 months. Missing month 24 C-peptide results are imputed using a conservative scenario.|Baseline (Pre-treatment), Month 24|Intent-to-treat||pmol/mL||95% Confidence Interval|Least Squares Mean
708227|NCT00129272|Secondary|Withdrawal Symptoms|Hughes-Hatsukami Withdrawal Scale|Nine weeks|Analyzed all participants with last observation carried forward (LOCF).||units on a scale;range0-36;higher worse||Standard Deviation|Mean
708228|NCT00129272|Primary|Smoking Behavior|Number of cigarettes smoked daily in the previous week|Nine weeks|Analyzed all randomized participants with last observation carried forward (LOCF).||cigarettes/day in the previous week||Standard Deviation|Mean
708229|NCT00129311|Primary|7 Day Point Prevalence of Cigarette Abstinence||Week 8|||participants|||Number
708230|NCT00129311|Primary|7 Day Point Prevalence of Cigarette Abstinence||6-month follow up|||participants|||Number
708231|NCT00129402|Secondary|Percent Change From Baseline in HDL-C||baseline to 6 weeks|ITT||percent change||Standard Error|Least Squares Mean
708232|NCT00129402|Secondary|Percent Change From Baseline in Apolipoprotein B (Apo B)||baseline to 6 weeks|ITT||percent change||Standard Error|Least Squares Mean
708233|NCT00129402|Secondary|Percent Change From Baseline in Triglycerides (TG)||baseline to 6 weeks|ITT||percent change||Standard Deviation|Median
708234|NCT00129402|Secondary|Percent Change From Baseline in Non High-density Lipoprotein Cholesterol (Non HDL-C)||baseline to 6 weeks|ITT||percent change||Standard Error|Least Squares Mean
708235|NCT00129402|Secondary|Percent Change From Baseline in Total Cholesterol (TC)||baseline to 6 weeks|ITT||percent change||Standard Error|Least Squares Mean
708236|NCT00129402|Primary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)|Least squares mean percent change from Baseline in LDL-C at the end of Step 1 (Week 6) in the pooled groups who received ezetimibe plus simvastatin compared with pooled groups who received simvastatin monotherapy|baseline to 6 weeks|The analysis was performed on the intent to treat (ITT) population. Although 248 subjects received randomized treatment, two of the subjects did not have at least one baseline and at least one postbaseline lipid determination and thus could not be analyzed in the ITT population. Therefore, the actual ITT population consisted of 246 subjects.||percent change||Standard Error|Least Squares Mean
708237|NCT00129441|Secondary|Repeatable Battery for the Assessment of Neuropsychological Status - Delayed Memory Subindex|"The Delayed Memory Index consists of verbal and nonverbal recall tasks (words, drawings) that the subject views early in the evaluation and without warning, is asked to recall ~1/2 hr later. Scores are expressed as standardized scores normalized to a population mean of 100, with a standard deviation of 15 (possible scores between 40-135). Higher scores reflect better performance. Subjects received the A form at baseline and wk-4 visit and the B form at the wk-2 visit (A/B forms are equivalent alternate forms, which allow for retesting patients without the confound of practice effects)."|Week 4|One subject dropped out before completing the study.||Standard Score||Standard Deviation|Mean
708238|NCT00129441|Secondary|Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Score|"Five index scores are computed from the RBANS (immediate memory, language, visuospatial, attention, delayed memory) that are combined to provide the Total Score. The Total Score is expressed as a standardized score normalized to a population mean of 100, with a standard deviation of 15 (possible scores 40-135). Higher scores reflect better performance. All subjects received the A form at baseline and the wk-4 visit and the B form at the wk-2 visit (the A/B forms are equivalent alternate forms, which allow for retesting patients without the confound of practice effects)."|Week 4|One subject dropped out before completing the study.||Standard Score||Standard Deviation|Mean
708239|NCT00129441|Secondary|Brief Psychiatric Rating Scale Total Score|The Brief Psychiatric Rating Scale-anchored (BPRS; Overall and Gorham, 1962; Woerner, Mannuzza, Kane, 1988) is an 18-item scale that is among the most widely used measure of psychopathology. Scores range from 1-7, with higher scores reflecting greater pathology. A total score is derived from the sum of all 18 items (possible scores range from 18-126). It relies on clinical judgment in the assessment of key areas of psychopathology (depression, anxiety, psychosis).|Week 4|One subject dropped out prior to completing study||Scores on a scale||Standard Deviation|Mean
708240|NCT00129441|Primary|Preparing to Overcome Prepotency Task - Error Rate|The POP task is a cued stimulus-response reversal paradigm that, similar to the AX Continuous Performance Test, requires increases in cognitive control through the maintenance and use of context information to overcome prepotent response tendencies.|Week 4|||proportion of errors||Standard Deviation|Mean
708241|NCT00129441|Primary|Preparing to Overcome Prepotency (POP) Task - Reaction Time|The POP task is a cued stimulus-response reversal paradigm that, similar to the AX Continuous Performance Test, requires increases in cognitive control through the maintenance and use of context information to overcome prepotent response tendencies.|Week 4|||msec||Standard Deviation|Mean
708756|NCT00144170|Secondary|Virologic Response at Week 24|Viral Load < 50 copies/mL|Week 24|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
708242|NCT00129441|Primary|AX Continuous Performance Test Task D-prime|For the AX Continuous Performance Test, subjects are required to maintain an attentional set across a delay interval in order to overcome a prepotent response tendency (target responses are required when an X is presented but only in the context of a preceding A; non-target conditions are AY, BX and BY). The dependent measure was d-prime at the long delay (calculated as AX hits minus BX false alarms, which is particularly sensitive to context processing impairments in individuals with schizophrenia.|Week 4|Four subjects did not complete a sufficient number of trials for the AXCPT task at both testing periods, therefore 7 L-830982 and 4 placebo subjects data were analyzed.||d-prime||Standard Deviation|Mean
708243|NCT00129441|Primary|N-back Task - Error Rate|The N-back task is a sequential-letter memory task for which working memory load is varied, as the respondent must indicate when the current stimulus matches the one from 'n' steps earlier in the sequence. The dependent measure for the N-back task was performance in the 2-back condition, which provides the best index of performance and dorsolateral prefrontal cortex disturbances in subjects with schizophrenia.|Week 4|Analyses included only those participants who completed the 4-week trial. One participant refused N-back at week-4, so 9 L-830982 and 5 placebo were analyzed.||proportion of errors||Standard Deviation|Mean
708244|NCT00129441|Primary|N-back Task - Reaction Time|The N-back task is a sequential-letter memory task for which working memory load is varied, as the respondent must indicate when the current stimulus matches the one from 'n' steps earlier in the sequence. The dependent measure for the N-back task was performance in the 2-back condition, which provides the best index of performance and dorsolateral prefrontal cortex disturbances in subjects with schizophrenia.|Week 4|Analyses included only those participants who completed the 4-week trial. One participant refused N-back at week-4, so 9 L-830982 and 5 placebo were analyzed.||msec||Standard Deviation|Mean
708245|NCT00129467|Primary|Days to Remission of Depression|Days to a 50% or greater reduction in initial Montgomery-Asberg Depression Rating Scale (MADRS) score.|18 Days|The number of participants analyzed is the number of who received the intervention||Days||Standard Error|Mean
708246|NCT00129480|Secondary|Depression Severity (Patient Health Questionnaire-depression Rating Scale at 6 and 12 Months); Clinician Adherence to Clinical Guidelines for Chronic Pain (Chart Review Conducted at 12 Months); Patient and Provider Satisfaction Questionnaires Completed||baseline, 3 month, 6 month, 12 month||||||
708247|NCT00129480|Primary|Pain-related Function (Roland Disability Score) at 12 Months|The Roland Morris Disability Questionnaire has 24 yes or no items. Each item is scored as 0 or 1. Item scores or summed to create total score with range 0 to 24. Higher scores represent greater disability. the Roland Morris has been widely used, has content and construct validity, internal consistency, and responsiveness to change among patients with chronic pain.|12 months|||Adjusted percent change||95% Confidence Interval|Mean
708248|NCT00129545|Secondary|Procedure Success|Implant procedure success is defined as the delivery and release of a WATCHMAN Device into the LAA.|Initial implant procedure|14 subjects did not have an implant procedure attempted||percentage of implant attempts|||Number
708249|NCT00129545|Primary|The Occurrence of Life-threatening Events, Including Device Embolization or Serious Bleeding Events|Serious bleeding events evaluated by the Clinical Events Committee included pericardial effusion requiring drainage, cranial bleeding events due to any source, gastrointestinal bleeds requiring transfusion, and any bleeding related to the device or procedure that necessitates an operation.|5 years|"Event rates reported per 100 patient-years (calculated as 100*N events/Total patient-years) total patient years 2717, 95% Credible Intervals per predefined Bayesian Statistics
Roll-in subjects were not included in the primary outcome analysis per study design."||Events per 100 pt-yrs||95% Confidence Interval|Number
708250|NCT00129545|Primary|Composite of Stroke, Systemic Embolism and Cardiovascular or Unexplained Death|A Bayesian model allowed for sequential evaluation of the primary endpoints, event rates reported per 100 patient-years (calculated as 100*N events/Total patient-years)|5 years|"event rates reported per 100 patient-years (calculated as 100*N events/Total patient-years) total patient years 2717, 95% Credible Intervals per predefined Bayesian Statistics
Roll-in subjects were not included in the primary outcome analysis per study design."||events per 100 pt yrs||95% Confidence Interval|Number
708251|NCT00129623|Secondary|Number of Participants With Marked Laboratory Abnormalities|Blood for laboratory tests was taken at screening and immediately before participants received their monthly study medication at months 3, 6, and 12. The laboratory tests included: Hematology [white blood cells (WBCs), platelets, hematocrit, and hemoglobin] and Chemistry [albumin, creatinine, blood urea nitrogen (BUN), alanine aminotransferase (ALT), total calcium, 25-hydroxy vitamin D, phosphate, magnesium, sodium, potassium, and chloride].|Screening up to 12 months|The safety population included participants who had at least one dose of the trial medication documented in the CRF whether withdrawn prematurely or not.||participants|||Number
708252|NCT00129623|Secondary|Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a participant who is administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.|Up to 15 days after end of study treatment (Approximately 2 years)|The safety population included participants who had at least one dose of the trial medication documented in the CRF whether withdrawn prematurely or not.||participants|||Number
708253|NCT00129623|Secondary|Percentage of Responders|Percent responders were defined as follows: Participants with a) lumbar spine (LS) BMD, equal to or above Baseline at Month 12 b) proximal femur BMD, equal to or above Baseline at Month 12 c) Both lumbar spine and proximal femur BMD, equal or above Baseline at Month 12. BMD of the lumbar spine was defined as the BMD of at least two vertebrae (L2-L4) that were not fractured and not affected by an osteoarthritic process, or a scanning artifact that could not be removed to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center. Proximal femur included total hip, trochanter and femoral neck sites.|Up to 12 months|The ITT population included participants who were randomized, received at least one dose of the trial medication and had baseline and at least one follow-up evaluation data point.||Percentage|||Number
708254|NCT00129623|Secondary|Absolute Change From Baseline in sCTX|Fasting blood samples were collected from participants for analysis of sCTX, which is a biochemical marker of bone resorption. Absolute change from baseline of sCTX after 3, 6, and 12 months of treatment was summarized using descriptive statistics.|Baseline and 3, 6, 12 months|The ITT population included participants who were randomized, received at least one dose of the trial medication and had baseline and at least one follow-up evaluation data point. n = the number of participants analyzed at a given time point.||ng/ml||95% Confidence Interval|Median
708255|NCT00129623|Secondary|Relative Change From Baseline in Serum C-telopeptide Crosslinks of Type 1 Collagen (CTX)|Fasting blood samples were collected from participants for analysis of serum CTX (sCTX), which is a biochemical marker of bone resorption. Relative change from baseline of sCTX after 3, 6, and 12 months of treatment was summarized using descriptive statistics.|Baseline and 3, 6 and 12 months|The ITT population included participants who were randomized, received at least one dose of the trial medication and had baseline and at least one follow-up evaluation data point. n = the number of participants analyzed at a given time point.||Percentage||95% Confidence Interval|Median
708256|NCT00129623|Secondary|Absolute Change From Baseline in BMD of the Proximal Femur at Month 12|BMD was measured by a single DEXA scan of the proximal femur at the time of screening and at Month 12. The absolute change from baseline in BMD of the proximal femur (total hip, trochanter, femoral neck) at Month 12 was summarized using descriptive statistics. BMD of fractured bones that could impact the scan area were not taken into account.|Baseline and Month 12|The ITT population included participants who were randomized, received at least one dose of the trial medication and had baseline and at least one follow-up evaluation data point.||g/cm^2||Standard Deviation|Mean
708257|NCT00129623|Secondary|Relative Change From Baseline in Mean Proximal Femur BMD at Month 12|BMD was measured by a single DEXA scan of the proximal femur at the time of screening and at Month 12. The relative (%) change from Baseline in BMD of the proximal femur (total hip, trochanter, femoral neck) at Month 12 was summarized using descriptive statistics. BMD of fractured bones that could impact the scan area were not taken into account.|Baseline and Month 12|The ITT population included participants who were randomized, received at least one dose of the trial medication and had baseline and at least one follow-up evaluation data point.||Percentage||Standard Deviation|Mean
708258|NCT00129623|Secondary|Absolute Change From Baseline in Mean Lumbar Spine BMD at Month 12|BMD was measured by a single dual-energy x-ray absorptiometry (DEXA) scan of the lumbar spine at the time of screening and at Month 12. A BMD measurement was considered unsuitable in case of detection of a fracture, an osteoarthritic process, or a scanning artifact that could not be removed to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center. The absolute change from Baseline in mean BMD of the lumbar spine (L2-L4) was measured as g/cm^2 and summarized using descriptive statistics.|Baseline and Month 12|The ITT population included participants who were randomized, received at least one dose of the trial medication and had baseline and at least one follow-up evaluation data point.||g/cm^2||Standard Deviation|Mean
708259|NCT00129623|Primary|Relative Change From Baseline in Mean Bone Mineral Density (BMD) of the Lumbar Spine (L2 to L4) at Month 12|BMD was measured by a single dual-energy x-ray absorptiometry (DEXA) scan of the lumbar spine at the time of screening and at Month 12. A BMD measurement was considered unsuitable in case of detection of a fracture, an osteoarthritic process, or a scanning artifact that could not be removed to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center. The change in BMD was defined as the relative difference between the last individual measurement available at 12 months and Baseline, using the following formula: Relative change = 100 x (BMD at 1 year - BMD at baseline) / (BMD at baseline)|Baseline and Month 12|The ITT population included participants who were randomized, received at least one dose of the trial medication and had baseline and at least one follow-up evaluation data point.||Percentage||Standard Error|Least Squares Mean
708260|NCT00123955|Secondary|Left Ventricular Diastolic Stiffness||Baseline, 4 and 9 months||||||
708261|NCT00123955|Secondary|Concentric Left Ventricular Remodeling||Baseline, 4 and 9 months||||||
708262|NCT00123955|Primary|Quality of Life||Baseline, 4 and 9 months||||||
708263|NCT00123955|Primary|Exercise Intolerance|Peak exercise VO2|Baseline, 4 and 9 months|The outcome measure data uses data from all participants with 4 and/or 9 month follow-up. Thirty-seven participants randomized to spironolactone and 35 participants randomized to placebo completed 4 months of follow-up, and 37 participants randomized to spironolactone and 34 participants randomized to placebo completed 9 months of follow-up.||ml/kg/min||Standard Deviation|Mean
708264|NCT00124020|Primary|Clinical Response|"Clinical Response: Categorical (Cured, Failed or Indeterminate)
Failure - at least one of the following:
Persistence or progression of signs and symptoms of pneumonia that still require antibiotic therapy
Termination of study med due to “lack of efficacy”
Death on or after Day 3 attributable to primary infection
Cure: Signs and symptoms of pneumonia improved to the point that no further antibiotics for pneumonia were required, and baseline radiographic findings improved or did not progress.
Indeterminate: Inability to determine outcome"|7-14 days following end of antibiotic treatment|||participants|||Number
708265|NCT00124072|Secondary|Total Strokes||6.7 years median follow-up||||||
708266|NCT00124072|Secondary|Major Coronary Events|Non-fatal MI, coronary death or coronary revascularisation|6.7 years median follow-up||||||
708267|NCT00124072|Secondary|MVEs in Presence and Absence of the Other Factorial Treatment||6.7 years median follow-up||||||
708268|NCT00124072|Secondary|MVEs in Patients Subdivided Into 3 Groups by Baseline Low-density Lipoprotein (LDL)||6.7 years median follow-up||||||
708269|NCT00124072|Secondary|MVEs Separately in Year 1 and in Later Years||6.7 years median follow-up||||||
708270|NCT00124072|Primary|Major Vascular Events (MVE)|Major vascular events (MVE) defined as major coronary events (MCE [non-fatal MI, coronary death or coronary revascularisation]), non-fatal or fatal stroke, or peripheral revascularization (peripheral artery angioplasty or arterial surgery, including amputations), during the scheduled study treatment period.|6.7 years median follow-up|||Participants|||Number
708271|NCT00124176|Secondary|Serum Albuterol S Isomer Levels||After 6 hours of continuous albuterol|||ng/mL||Standard Deviation|Mean
708272|NCT00124176|Secondary|Serum Potassium Levels||After 12 hours of continuous nebulization|||mg/dL||Standard Deviation|Mean
708273|NCT00124176|Secondary|Heart Rate||After 12 hours of continuous nebulization|||beats per minute||Standard Deviation|Mean
708279|NCT00129766|Secondary|The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 4|Mean serum concentrations of motavizumab at 30 days post Dose 4|30 days post Dose 4|The Pharmacokinetics/Immunogenicity (PK/IM) Population included all patients who received study drug and who did not receive non-study commercial palivizumab within 3 months prior to receiving the first dose of study drug. Includes subjects with both baseline and a post-dose 4 measurements||ug/mL||Standard Deviation|Mean
708280|NCT00129766|Secondary|The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 3|Mean serum concentrations of motavizumab at 30 days post Dose 3|30 days post Dose 3|The Pharmacokinetics/Immunogenicity (PK/IM) Population included all patients who received study drug and who did not receive non-study commercial palivizumab within 3 months prior to receiving the first dose of study drug. Includes subjects with both baseline and a post-dose 3 measurements||ug/mL||Standard Deviation|Mean
708281|NCT00129766|Secondary|The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 2|Mean serum concentrations of motavizumab at 30 days post Dose 2|30 days post Dose 2|The Pharmacokinetics/Immunogenicity (PK/IM) Population included all patients who received study drug and who did not receive non-study commercial palivizumab within 3 months prior to receiving the first dose of study drug. Includes subjects with both baseline and a post-dose 2 measurements||ug/mL||Standard Deviation|Mean
708282|NCT00129766|Secondary|The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 1|Mean serum concentrations of motavizumab at 30 days post Dose 1|30 days post Dose 1|The Pharmacokinetics/Immunogenicity (PK/IM) Population included all patients who received study drug and who did not receive non-study commercial palivizumab within 3 months prior to receiving the first dose of study drug. Includes subjects with both baseline and a post-dose 1 measurements||ug/mL||Standard Deviation|Mean
708283|NCT00129766|Secondary|The Serum Concentrations of Motavizumab at Day 0|Mean serum concentrations of motavizumab at Day 0|Day 0|The Pharmacokinetics/Immunogenicity (PK/IM) Population included all patients who received study drug and who did not receive non-study commercial palivizumab within 3 months prior to receiving the first dose of study drug.||ug/mL||Standard Deviation|Mean
708284|NCT00129766|Secondary|The Number of Participants With Anti-motavizumab Antibodies|Detection of anti-motavizumab antibodies was defined as a titer with a dilution value equal to or greater than 1:10.|Day 0 - 120|N varied at different timepoints: at pre-dose 1 N=3193; at 30 days post-dose 1 N=998; at 30 days post-dose 2 N=1049; at 30 days post-dose 3 N=1049; at 30 days post-dose 4, N=3013; at any time post baseline, N=3217||participants|||Number
708285|NCT00129766|Secondary|The Frequency of Prescribed Antibiotics for Medically-attended OM Infections|The average number of presciptions per event per subject was summarized for each treatment group.|Days 0 - 150|The Intent-to-Treat (ITT) Population included all patients randomized into the study.||number of prescriptions||Standard Deviation|Mean
708286|NCT00129766|Secondary|The Frequency of Prescribed Antibiotics for Medically-attended LRI|The average number of presciptions per event per subject was summarized for each treatment group.|Days 0 - 150|The Intent-to-Treat (ITT) Population included all patients randomized into the study.||Number of prescriptions||Standard Deviation|Mean
708287|NCT00129766|Secondary|The Incidence of Medically-attended Otitis Media (OM) Infections|Otitis media (OM) was to be recorded as the diagnosis if the following terms were used by the medical care provider: acute OM, acute tympanic membrane (TM) perforation, bulging TM, red TM with fever, OM with effusion, or middle ear effusion. A new episode was defined as a physician-diagnosed OM in either ear after a normal middle ear exam of the ear in question or an episode of acute OM greater than or equal to 21 days after resolution of the previous episode. A diagnosis of persistent middle ear effusion was not to be recorded as a new OM event.|Days 0 - 150|The Intent-to-Treat (ITT) Population included all patients randomized into the study.||Participants|||Number
708288|NCT00129766|Secondary|The Incidence of RSV-specific Medically-attended Outpatient Lower Respiratory Illnesses (LRIs) Between Treatment Groups|The RSV-specific LRI was defined as an outpatient medically-attended LRI associated with a positive RSV test and was not inclusive of events that required hospitalization.|Days 0 - 150|Subjects were from a pre-specified subsets of sites participating in the nasal secretion sample collection for this endpoint.||Participants|||Number
708289|NCT00129766|Secondary|The Incidence of Outpatient Medically-attended Lower Respiratory Illness (LRI)|LRI was defined as an event of bronchiolitis or pneumonia or the occurance of a lower tract infectious illness as determined by the PI based on medical history, signs, and symptoms.|Day 0 - 150|The Intent-to-Treat (ITT) Population included all patients randomized into the study.||Participant|||Number
708290|NCT00129766|Primary|Number of Participants Reporting Changes in Vital Signs From Baseline|Vital signs that were in a higher toxicity grade than observed at baseline were to be recorded as AEs|Days 0 - 150|The Safety Population included all patients who received any study drug and had any safety follow-up.||participants|||Number
708291|NCT00129766|Primary|Number of Participants Who Died||Days 0 - 150|The Safety Population included all patients who received any study drug and had any safety follow-up.||participants|||Number
708292|NCT00129766|Primary|Number of Participants Who Discontinued Study Drug Due to AEs||Days 0 - 150|The Safety Population included all patients who received any study drug and had any safety follow-up.||participants|||Number
708293|NCT00129766|Primary|Number of Participants Reporting AEs by Highest Severity Grade|Adverse events events were graded by severity; Level 1, 2, 3, or 4|Days 0 - 150|The Safety Population included all patients who received any study drug and had any safety follow-up.||participants|||Number
708294|NCT00129766|Primary|Number of Participants Reporting Any Related SAEs|Number of participants reporting one or more SAEs considered related to study drug by the investigator|Days 0 - 150|The Safety Population included all patients who received any study drug and had any safety follow-up.||participants|||Number
708295|NCT00129766|Primary|Number of Participants Reporting Any Serious Adverse Events (SAEs)|Number of participants reporting one or more SAEs|Days 0 - 150|The Safety Population included all patients who received any study drug and had any safety follow-up.||participants|||Number
708296|NCT00129766|Primary|Number of Participants Reporting Any Related AEs|Number of participants reporting one or more AEs considered related to study drug by the investigator|Days 0 - 150|The Safety Population included all patients who received any study drug and had any safety follow-up.||participants|||Number
708297|NCT00129766|Primary|Number of Participants Reporting Any Adverse Events (AEs)|Number of participants reporting one or more AEs|Days 0 - 150|The Safety Population included all patients who received any study drug and had any safety follow-up.||participants|||Number
708298|NCT00129766|Primary|Incidence of RSV Hospitalization (Includes Deaths by RSV)|RSV hospitalization was defined as 1) a respiratory hospitalization with a positive RSV test (primary), 2) a new onset of lower respiratory symptoms in an already hospitalized child, with an objective measure of worsening respiratory status and positive RSV test (nosocomial), or 3) death demonstrated to have been caused by RSV (by autopsy or clinical history and virologic evidence).|Days 0 - 150|The Intent-to-Treat (ITT) Population included all patients randomized into the study.||Participants|||Number
708299|NCT00129961|Secondary|Spot Urine Protein:Creatinine Ratio|Subjects’ urine protein:creatinine ratios were summarized by each scheduled visit, and the nonparametric Wilcoxon rank sum test was used to compare the difference between groups.|At 24 months (Week 104)|Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up. Available data, no imputations.||ratio (mg/mg)||Full Range|Median
708300|NCT00129961|Secondary|Number of Subjects With Biopsy-Confirmed Acute Rejection||up to 24 months|Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up.||subjects|||Number
708301|NCT00129961|Secondary|Graft Survival Measured by Graft Loss|Graft loss was defined as physical loss (nephrectomy), functional loss (necessitating maintenance dialysis for >8 consecutive weeks), retransplant, or death.|up to 24 months|Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up.||graft loss|||Number
708302|NCT00129961|Secondary|Number of Participants That Died||up to 24 months|Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up.||participants|||Number
708303|NCT00129961|Secondary|Serum Creatinine Level|Serum creatinine is an indicator of kidney function. Creatinine is a substance formed from the metabolism of creatinine, commonly found in blood, urine, and muscle tissue. It is removed from the blood by the kidneys and excreted in urine. An increased level of creatinine in the blood indicates decreased kidney function. Normal adult blood levels of creatinine are 0.5 to 1.1 mg/dL for females and 0.6 to 1.2 mg/dL for males, however the normal values are age-dependent as elderly patients typically have smaller muscle mass.|At 24 months (Week 104)|Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up. All available data, no imputations.||μmol/L||Standard Deviation|Mean
708304|NCT00129961|Secondary|Nankivell-Calculated Glomerular Filtration Rate (GFR)|GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. GFR can be measured directly or estimated using established formulas. For this study, GFR was calculated using Nankivell. A normal GFR is > 90 mL/min, although children and older people usually have a lower GFR. Lower values indicate poor kidney function. A GFR <15 is consistent with kidney failure.|At 24 months (week 104)|Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up. For the intention to treat analysis, a GFR of 0 was imputed for graft loss or death, and last observation carried forward (LOCF) for missing values.||units on scale||Standard Deviation|Mean
708305|NCT00129961|Secondary|Number of Subjects Who Discontinue Assigned Therapy||up to 24 months|Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up.||participants|||Number
708306|NCT00129961|Secondary|Death Due to NMSC||up to 24 months|Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up.||participants|||Number
708307|NCT00129961|Secondary|Subjects Reporting Incidence of Metastatic Disease Related to NMSC.|The number of subjects with metastatic disease related to NMSC.|up to 24 months|Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up.||participants|||Number
708308|NCT00129961|Secondary|Number of Recurrent NMSC Lesions Per Subject-year|Recurrent NMSC lesions is defined as recurring at the site of a previously treated lesion.|up to 24 months|Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up.||lesions per participant year|||Number
708309|NCT00129961|Secondary|Grade Distribution of NMSC Lesions|Number of subjects with at least 1 biopsy-confirmed new squamous cell carcinoma (SCC) or basal cell carcinoma (BCC).|up to 24 months|Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up.||participants|||Number
708310|NCT00129961|Secondary|Percentage of Patients With New Biopsy-confirmed NMSC: Squamous Cell Carcinoma (SCC) and Basal Cell Carcinoma (BCC)||up to 24 months|Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up.||Percentage of Participants|||Number
708311|NCT00129961|Secondary|Number of Lesion Free Subjects|The overall number of subjects who were lesion free were compared between treatment groups with the Cochran Mantel Haenszel test stratified by baseline NMSC stratum. Within each stratum, the Fisher exact test was used to compare the proportions of lesion free subjects between treatment groups.|up to 24 months|Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up.||participants|||Number
708312|NCT00129961|Secondary|Time to First Biopsy Confirmed New NMSC Lesion.|The time to first biopsy confirmed new NMSC lesion starts at 1 day post randomization to biopsy and/or treatment of newly confirmed NMSC lesion.|up to 24 months|Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up.||number of days||95% Confidence Interval|Median
708313|NCT00129961|Primary|New Biopsy-Confirmed Nonmelanoma Skin Cancer (NMSC) Lesions Per Subject Per Year|The number of new biopsy-confirmed NMSC lesions per subject per year was calculated by summarizing the total number of new BCC and SCC lesions reported over the observation period and standardizing it to an annual rate by multiplying by 365 and dividing by days on study.|up to 24 months|Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up.||Standardized Yearly Rate of NMSC|||Number
708314|NCT00129974|Secondary|Number of Participants With at Least One Adverse Event|Number of Participants with at least one Adverse Event|Study Termination||||||
708315|NCT00129974|Primary|Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Study Termination||||||
708316|NCT00130117|Secondary|Hip BMD||9months|||g/cm2||Inter-Quartile Range|Median
708317|NCT00130117|Secondary|Radial BMD||9 months|||g/cm2||Inter-Quartile Range|Median
708318|NCT00130117|Secondary|Lumbar BMD||9 months|||g/cm2||Inter-Quartile Range|Median
708319|NCT00130117|Secondary|Total Body BMD||9 months|||g/cm2||Inter-Quartile Range|Median
708320|NCT00130117|Secondary|Body Fat||36 weeks|||fat %||Standard Error|Mean
708321|NCT00130117|Secondary|Total Body BMD||36 weeks|||g/cm^2||Inter-Quartile Range|Median
708322|NCT00130117|Secondary|Body Composition BMI||36 weeks|||BMI-kg/m^2||Standard Error|Mean
708323|NCT00130117|Secondary|Bone Markers - Ctx and Sclerostin||36 weeks|Only for subjects participating in both phase A and phase B (n=4), bone markers were assessed to see the change over 24 month period. All these patient got metreleptin treatment||ng/mL||Inter-Quartile Range|Median
708324|NCT00130117|Primary|the Difference Between the Placebo and Leptin Treated Groups in the Change in Bone Mineral Content(BMC) at the Anteroposterior (AP) Spine From Baseline to 36 Weeks||36 weeks|||g||Full Range|Mean
708325|NCT00130247|Secondary|Microbiologic: Time After Inoculation Until Culture Positive in BACTEC 460 or MGIT 960 Enriched Liquid Media After 2 Months in Treatment - Results Are Pending||Months 1, 2, 3, 4, 5, 6, 9, 12, 15, 18, 24, and 30||||||
708326|NCT00130247|Primary|Bacteriologic or Clinical Relapse at 30 Months After Onset of Initial Anti-TB Treatment - Per-protocol|Patients who presented with TB after completion of study phase treatment but before the end of follow-up were classified as relapses. A bacteriologic relapse was defined as a patient who became consistently culture-positive [defined as at least 1 of the following]: (a) at least 1 sputum mycobacterial culture growing at least 10 colonies of MTB on solid medium; (b) 2 or more respiratory secretion cultures that are positive for MTB in liquid media; or (c) any culture from an extrapulmonary site that is positive for MTB during follow-up after successful completion of initial anti-TB treatment.|30 months|The per-protocol analysis included all 370 patients (185 per treatment arm) who received the intervention, completed treatment and full follow-up and did not have exogenous reinfection of TB. The 24 excluded subjects included 2 patients with exogenous reinfection of TB, 12 lost to follow-up, 4 deaths, and 6 who did not receive the intervention.||Participants|||Number
708327|NCT00130247|Secondary|Microbiologic: Changes in Sputum Mycobacterial mRNA - Results Are Pending||At 1 and 2 months of anti-TB treatment, and upon relapse||||||
708328|NCT00130247|Secondary|Immunologic: Changes in Sputum Cytokine Levels - Results Are Pending||After 1 and 2 months of anti-TB treatment||||||
708329|NCT00130247|Secondary|Immunologic: Store Peripheral Blood Mononuclear Cells (PBMC) - Results Are Pending||Pre-treatment and serum pre-treatment after 2 and 6 months of anti-TB treatment, and at the time of relapse for future immunologic analysis||||||
708330|NCT00130247|Secondary|Immunologic: Changes in Cytokine Levels in Mycobacterium Tubercolosis (MTB) Antigen-stimulated Whole Blood Culture Supernatants - Results Are Pending||After 2 and 6 months of anti-TB treatment and upon relapse||||||
708331|NCT00130247|Secondary|Acquired Drug Resistance in Patients Who Relapsed||2 years|This analysis was per protocol and looked for acquired drug resistance among the 13 patients in the 4-Month Arm who relapsed and the 3 patients in the 6-Month Arm who relapsed.||Participants|||Number
708332|NCT00130247|Secondary|Relapses at 1 and 2 Years||1 and 2 years after successful completion of initial anti-TB treatment|Analysis includes the 386 patients who received the intervention, completed treatment, and started post-treatment follow-up (193 patients in each treatment arm). Two subjects were lost after completing treatment and contributed no follow-up time, and 6 subjects did not receive the intervention so were not included in the analysis.||Participants|||Number
708333|NCT00130247|Secondary|Treatment Failures or Relapses at 2 Years After Completion of TB Treatment: Per Protocol|A culture-positive treatment failure was defined as initial culture conversion but subsequent reversion to culture positivity. A clinical treatment failure was defined as a patient with clinical and/or radiographic evidence of progressive tuberculosis not confirmed by a positive culture after 4 or more months of anti-TB treatment while still receiving treatment. Patients who defaulted before completing study treatment and returned later with culture-positive tuberculosis were termed failures after non-adherence.|2 years|The per-protocol analysis included all 370 patients (185 per treatment arm) who received the intervention, completed treatment and full follow-up and did not have exogenous reinfection of TB. The 24 excluded subjects included 2 patients with exogenous reinfection of TB, 12 lost to follow-up, 4 deaths, and 6 who did not receive the intervention.||Participants|||Number
708334|NCT00130247|Secondary|Treatment Failures or Relapses at 2 Years After Completion of TB Treatment: Intention to Treat|A culture-positive treatment failure was defined as initial culture conversion but subsequent reversion to culture positivity. A clinical treatment failure was defined as a patient with clinical and/or radiographic evidence of progressive tuberculosis not confirmed by a positive culture after 4 or more months of anti-TB treatment while still receiving treatment. Patients who defaulted before completing study treatment and returned later with culture-positive tuberculosis were termed failures after non-adherence.|2 years|The intention to treat (ITT) analysis included all 394 fully eligible and randomized patients allocated to the shortened 4-month treatment group (N=196) or the standard 6-month treatment group (N=198). There were no allocated patients excluded in the ITT analysis dataset.||Participants|||Number
708757|NCT00144170|Secondary|Virologic Response at Week 16|Virologic response defined as Viral Load<50 copies/mL|Week 16|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
708335|NCT00130247|Primary|Bacteriologic or Clinical Relapse at 30 Months After Onset of Initial Anti-tuberculosis (TB) Treatment - Intention-to-treat|Patients who presented with TB after completion of study phase treatment but before the end of follow-up were classified as relapses. A bacteriologic relapse was defined as a patient who became consistently culture-positive [defined as at least 1 of the following]: (a) at least 1 sputum mycobacterial culture growing at least 10 colonies of MTB on solid medium; (b) 2 or more respiratory secretion cultures that are positive for MTB in liquid media; or (c) any culture from an extrapulmonary site that is positive for MTB during follow-up after successful completion of initial anti-TB treatment.|30 months|The intention to treat (ITT) analysis included all 394 fully eligible and randomized patients allocated to the shortened 4-month treatment group (N=196) or the standard 6-month treatment group (N=198). There were no allocated patients excluded in the ITT analysis dataset.||Participants|||Number
708336|NCT00130286|Secondary|Change in Subcutaneous Adipose Tissue Volume|"Change in subcutaneous adipose tissue volume from baseline to week 12 by whole body MRI
Data are presented only for subjects who had MRI scans done at both time points."|12 weeks|||L||Standard Deviation|Mean
708337|NCT00130286|Secondary|Change in Visceral Adipose Tissue Volume|"Change in visceral adipose tissue volume from baseline to week 12 measured by whole body MRI
Data are presented only for subjects who had MRI scans done at both time points."|12 weeks|||L||Standard Deviation|Mean
708338|NCT00130286|Primary|Change in Insulin Sensitivity|"Change in insulin sensitivity value from baseline to week 12 by frequently sampled intravenous glucose tolerance test
This assessment was only conducted at baseline and week 12; therefore the change reflects the difference between these two time points."|12 weeks|||uU*10^-4*min*ml^-1||Inter-Quartile Range|Median
708339|NCT00130520|Primary|Median Response Duration (Weeks)|Response duration=time (in weeks) between date of measurable response and date of progression (progression=20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed or baseline, progression of non-measurable disease in opinion of treating physician, any new lesion/site, death due to disease)if known or the date the subject went off protocol if they were still considered responders (ie do not qualify as progression) or are stable (Does not qualify for CR, PR, progression or Symptomatic Deterioration)|1 week to 96 weeks|Population=subjects receiving 1 dose of intervention and one assessment post-baseline. One subject=not evaluable. Analysis-Enroll 40, initial accrual of 20. If ≤1 confirmed responses observed in 20=closure. If ≥2 responses=20 additional.||weeks||Full Range|Median
708340|NCT00130520|Secondary|Progression Free Survival(PFS)|PFS was defined as the time from the start of therapy to the time of the first documentation of progression(progression=20% increase in sum of longest diameters of target measurable lesions over smallest sum observed or baseline, progression of non-measurable disease in the opinion of treating physician, appearance of new lesion/site, Death due to disease), symptomatic deterioration (global deterioration of health status requiring discontinuation of treatment without objective evidence of progression), or death due to any cause;|June 2005 to October 5, 2009|The population analyzed included all participants receiving at least 1 dose of study intervention and at least one assessment post-baseline. One subject was not evaluable. Analysis was per protocol||months||Full Range|Median
708341|NCT00130520|Primary|Objective Response (Complete Partial, Stable and Progression)|Objective response was defined using standard RECIST criteria. CR(complete response)= disappearance of all target lesions PR(partial response)=30% decrease in the sum of the longest diameter of target lesions PD(progressive disease)=20% increase in the sum of the longest diameter of target lesions SD(stable disease)= small changes that do not meet above criteria|06.16.2005 to 10.05.2009|Population=subjects receiving 1 dose of intervention and one assessment post-baseline. One subject=not evaluable. Analysis-Enroll 40, initial accrual of 20. If ≤1 confirmed responses observed in 20=closure. If ≥2 responses=20 additional.||Participants|||Number
708342|NCT00130637|Primary|Number of Participants Reporting a Serious Adverse Event (SAE)|Safety of acute daclizumab use in JIA-associated uveitis was assessed through serious adverse events (SAE).|52 weeks|||participant|||Number
708343|NCT00130637|Primary|Number of Participants With a Two-step Reduction in Inflammation|Number of participants with a two-step reduction (or down to 0 out of a scale of 0 to 4+) of anterior chamber (AC) inflammation according to Standardization of Uveitis Nomenclature (SUN) criteria, while on a topical corticosteroid schedule of less than 3 times a day. Grade 0 is the best score on this scale with <1 cell in the field and 4+ is the worst score on this scale with >50 cells in the field.|12 weeks|||participants|||Number
708344|NCT00130689|Primary|Overall Response Rate|Overall response (OR) rate was defined as achieving partial response (PR) or complete response (CR) based on RECIST 1.0 criteria on treatment. Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.|Disease was evaluated radiologically at baseline and every 2 cycles on treatment; Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 6 weeks (range 1-23 weeks).|Responses were determined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.||proportion of paticipants||90% Confidence Interval|Number
708349|NCT00130780|Primary|The Primary Goal of This Study is to Show That the Addition of Bevacizumab to Cisplatin-based Chemotherapy in the Neoadjuvant Setting for Non-squamous Cell Carcinomas Improves Therapeutic Response/Outcome Assessment.|These criteria have been modified for the purpose of this study (i.e.: there will be no confirmation of response at 4 weeks per usual response criteria as this is not applicable to the preoperative treatment plan): Complete Response (CR): Disappearance of all clinical evidence of tumor. Partial Response (PR): A 50% or greater decrease in the sum of the products of measured lesions. No simultaneous increase in the size of any lesion or the appearance of new lesions may occur. Non-measurable lesions must remain stable or regress for this category. Minor Response (MR): A > 25% and < 50% decrease in the sum of the products of measured lesions. No simultaneous increase in the size of any lesion or the appearance of new lesions may occur. Non-measurable lesions must remain stable or regress for this category. Stable Disease (SD): A less than 25% decrease. This includes a decrease of less than 25% in the sum of the products of the meas|2 years|||participants|||Number
708350|NCT00130793|Other Pre-specified|Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers From Prevaccination to 4 Weeks Postvaccination|GMFR of the VZV antibody response from prevaccination to Week 4 postvaccination|From prevaccination (baseline) to 4 weeks postvaccination|The primary immunogenicity analyses were based on the per-protocol population defined as subjects who had valid results from samples obtained within the prespecified day ranges at Day 1 or at Week 4 postvaccination, and who did not meet any of the protocol violations prespecified in the SAP.||gpELISA units/mL||95% Confidence Interval|Geometric Mean
708351|NCT00130793|Secondary|Vaccine-Related Serious Adverse Experiences (SAEs) for 28 Days Postvaccination|Vaccine-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) serious adverse experiences are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose|4 weeks|All vaccinated subjects with safety follow-up are included.||Participants|||Number
708352|NCT00130793|Primary|Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination|The GMT of the VZV-specific antibody responses as measured by gpELISA (glycoprotein enzyme-linked immunosorbent assay) at 4 weeks postvaccination in subjects who received ZOSTAVAX™ with PGSU and in subjects who received ZOSTAVAX™ with PGS.|4 weeks|The primary immunogenicity analyses were based on the per-protocol population defined as subjects who had valid results from samples obtained within the prespecified day ranges at Day 1 or at Week 4 postvaccination, and who did not meet any of the protocol violations prespecified in the statistical analysis plan (SAP)||gpELISA units/mL||95% Confidence Interval|Geometric Mean
708353|NCT00130832|Primary|Immunogenicity of RotaTeq™ as Measured by Serum Neutralizing Antibody [SNA] Responses to Rotavirus Serotypes G1, G2, G3, G4, and P1A When Administered With OPV Concomitantly or Staggered|Rotavirus SNA response to serotypes G1, G2, G3, G4, and P1A measured at postdose 3 in subjects receiving RotaTeq™ and OPV concomitantly compared to staggered.|Approximately 42 days Postdose 3|"Per Protocol Population
For serotype G4 the RotaTeq and Oral Poliovirus (OPV) concomitantly group N = 350"||GMT||95% Confidence Interval|Geometric Mean
708354|NCT00130832|Primary|GMT of Serum Anti-rotavirus Immunoglobulin A (IgA)|GMT of serum anti-rotavirus IgA measured at postdose 3 in subjects receiving RotaTeq™ and OPV concomitantly compared to staggered|Approximately 42 days Postdose 3|Per Protocol Population||GMT||95% Confidence Interval|Geometric Mean
708355|NCT00130832|Primary|Geometric Mean Titer(s) of Poliovirus Types 1, 2, and 3, Measured Approximately 42 Days Postdose 3|GMT of poliovirus type 1, 2, and 3, measured at postdose 3 in subjects receiving RotaTeq™ and OPV concomitantly compared to staggered.|Approximately 42 days Postdose 3|The primary immunogenicity analyses were based on evaluable per-protocol subjects who received all scheduled doses, were not protocol violators, and had valid assay values.||Geometric Mean Titer (GMT)||95% Confidence Interval|Geometric Mean
708356|NCT00130923|Secondary|Clinical Symptoms, Global Functioning, Cognition, and Extrapyramidal System Effects||6 months||||||
708357|NCT00130923|Secondary|Other Substance Use as Assessed by the Timeline Followback Scale||6 months||||||
708358|NCT00130923|Primary|Mean Heavy Drinking Days Per Week||6 months|||Drinking days per week||Standard Deviation|Mean
708359|NCT00131248|Primary|Bradycardia Episodes/Day||7 days|18 participants originally enrolled, 1 withdrew, leaving 17 participants analyzed.||episodes per day||Standard Deviation|Mean
708360|NCT00131352|Secondary|Participants Classified as Responders Per the Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Criteria at Week 26|"Participants were classified as a positive responder if at least one of the following two conditions were met:
A significant improvement in either the pain (WOMAC A) or physical function (WOMAC C) subscales, defined as both a ≥ 50% improvement from Baseline and an absolute change from Baseline of ≥ 20 normalised units (NU), OR
Improvement in at least 2 of 3 subscales - pain (WOMAC A), physical function (WOMAC C) or Participant Global Assessment (PTGA). Improvement for all three scales is defined as ≥ 20% improvement from Baseline and an absolute change from Baseline of ≥ 10 NU"|Week 26|Intent-To-Treat (ITT) population.||participants|||Number
708361|NCT00131352|Secondary|Clinical Observer Global Assessment (COGA) of the Target Knee Osteoarthritis (OA) Condition at Week 26|The Blinded Clinical Observer gave a global assessment (COGA) of the target knee OA. COGA uses 5 scoring levels: Very well=0, Well=1, Fair=2, Poor=3, Very poor=4.|Week 26|Intent-To-Treat (ITT) population||participants|||Number
708362|NCT00131352|Secondary|Participant Global Assessment (PTGA) of the Target Knee Osteoarthritis Condition at Week 26|The Participant Global Assessment (PTGA) was used by participants to rate their osteoarthritis (OA). PTGA uses 5 scoring levels: Very well=0, Well=1, Fair=2, Poor=3, Very poor=4.|Week 26|Intent-To-Treat (ITT) population||participants|||Number
708444|NCT00132691|Secondary|Cataract - Incident Cataract||24 months|Eyes with uveitis, not participants, were analyzed. Eyes with prevalent complications or missing data at enrollment were were excluded from the risk set.||percentage of eyes with uveitis at risk|Participants|95% Confidence Interval|Number
708363|NCT00131352|Secondary|Change From Baseline at Week 26 in Physical Function Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale (WOMAC LK Version 3.1) C (Function) Subscale|The change from baseline to week 26 using participants' assessment of physical function. The WOMAC Function Subscale has a score range of 0–4 to assess the degree of difficulty completing tasks within the past 48 hours, where 0=no difficulty and 4=extreme difficulty.|Day 0, Week 26|Intent-To-Treat (ITT) population.||units on a scale||Standard Error|Mean
708364|NCT00131352|Secondary|Change From Baseline Over the Course of the 26-week Initial Treatment Period in Physical Function Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale (WOMAC LK Version 3.1) C (Function) Subscale|The change from baseline over the course of the 26-week initial treatment period using participants' assessment of physical function. Mean scores were used for baseline (day 0) and for all visits up to week 26 (weeks 4, 8, 12, 18 and 26). The WOMAC Function Subscale has a score range of 0–4 to assess the degree of difficulty completing tasks within the past 48 hours, where 0=no difficulty and 4=extreme difficulty.|Day 0, up to week 26|Intent-To-Treat (ITT) population.||units on a scale||Standard Error|Mean
708365|NCT00131352|Secondary|Participants Level of Pain While Walking at Week 26 As Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) A1 (Walking Pain) Subscale|Participants categorized the pain they felt while walking using the WOMAC LK 3.1) A1 (Walking Pain) Subscale. The scale rates pain as none, mild, moderate, severe and extreme.|Week 26|Intent-To-Treat (ITT) population||participants|||Number
708366|NCT00131352|Secondary|Change From Baseline in Knee Pain at Week 26 As Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) A (Pain) Subscale|The change from baseline to week 26 using participants' assessment of pain. The WOMAC Pain Subscale has a score range of 0–4, where 0=no pain and 4=extreme pain.|Day 0, Week 26|Intent-To-Treat (ITT) population.||units on a scale||Standard Error|Mean
708367|NCT00131352|Primary|Change From Baseline in Knee Pain Over the Course of the 26-week Initial Treatment Period As Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) A (Pain) Subscale|The change from baseline over the course of the 26-week initial treatment period using participants' assessment of pain. Mean scores were used for baseline (day 0) and for all visits up to week 26 (weeks 4, 8, 12, 18 and 26). The WOMAC Pain Subscale has a score range of 0–4, where 0=no pain and 4=extreme pain.|Day 0, up to week 26|Intent-To-Treat (ITT) population which included all participants randomized to study treatment on Day 0.||units on a scale||Standard Error|Mean
708368|NCT00131378|Primary|Abdominal Fat|6 month change in visceral abdominal fat (primary body composition endpoint)|Measured at baseline and month 6|||cm^2||Standard Error|Mean
708369|NCT00131378|Primary|Total Abdominal Fat|6 month change in total abdominal fat (primary body composition endpoint)|Measured at baseline and month 6|||cm^2||Standard Error|Mean
708370|NCT00131378|Secondary|Insulin-like Growth Factor-1 (IGF-1) Levels|6-month change in IGF-1 levels|Measured at baseline and month 6|||ng/mL||Standard Error|Mean
708371|NCT00131378|Secondary|Measure of Insulin Resistance|6 month change in 2-hour glucose (primary insulin resistance endpoint)|Measured at baseline and month 6|||mg/dL||Standard Error|Mean
708372|NCT00131378|Primary|HsCRP|6 month change in HsCRP (primary cardiovascular risk endpoint)|Measured at baseline and month 6|ITT||mg/L||Standard Error|Mean
708373|NCT00131456|Primary|Two Consecutive Weeks of Marijuana Abstinence|The primary outcome measure for marijuana use was a dichotomous abstinence response,defined as at least two consecutive urine-confirmed abstinent weeks. Each week during the study, subjects were scored as urine-confirmed abstinent if both self-reported marijuana use for that week was negative, according to the quantitative substance use daily inventory (Timeline FollowBack), and all urines collected for that week were negative for THC. Patients who achieved the two consecutive abstinent weeks were classified as abstinent whether or not they subsequently dropped out of the study. Patients who dropped out of the study without achieving two continuous weeks of abstinence were classified as not abstinent.|measured daily by self report for 12 weeks of the trial or length of study participation|All analyses were conducted based on the intent-to-treat principle.||participants|||Number
708374|NCT00131508|Secondary|Change in Hand Grip From Baseline to 12 Months.|"To investigate the clinical effects of oral glutamine and placebo on hand grip in children with Sickle Cell Anemia (SCA) by comparing the difference between baseline and 12 months of treatment between the two groups.
Hand grip strength is a measure of muscle strength.Units are measured in Kg.Muscle strength is measured using a hydraulic hand-held dynamometer.Change was defined as 12 Month measure minus baseline.Muscle strength is measured using the hand grip strength via a hydraulic hand-held dynamometer (Kg)."|Baseline and 12 months|Analyzed patients had a height measurement at both baseline and 12 months.||kg||Full Range|Median
708375|NCT00131508|Secondary|Change in Pulse Rate From Baseline to 12 Months|To investigate the clinical effects of oral glutamine and placebo on pulse rate in children with Sickle Cell Anemia (SCA) by comparing the difference between baseline and 12 months of treatment between the two groups.|Baseline and 12 months|Analyzed patients had a height measurement at both baseline and 12 months.||Beats per minute (BPM)||Full Range|Median
708376|NCT00131508|Secondary|Change in Weight Percentile From Baseline to 12 Months|To investigate the effect of oral glutamine and placebo on weight in children with Sickle Cell Anemia (SCA) between baseline and 12 months on treatment.|Basline and 12 months|Analyzed patients had a height measurement at both baseline and 12 months.||Percentile||Full Range|Median
708377|NCT00131508|Secondary|Change in Height Percentile From Baseline to 12 Months|To investigate the effect of oral glutamine and placebo on height percentile in children with Sickle Cell Anemia (SCA) between baseline and 12 months on treatment.|Baseline and 12 months|Analyzed patients had a height measurement at both baseline and 12 months.||Percentile||Full Range|Median
708378|NCT00131508|Secondary|Change in Height Z-score From Baseline to 12 Months|To investigate the effect of oral glutamine and placebo on height Z-score in children with Sickle Cell Anemia (SCA) between baseline and 12 months on treatment.|Baseline and 12 months|Analyzed patients had a height measurement at both baseline and 12 months.||Z-score||Full Range|Median
708445|NCT00132691|Secondary|Intraocular Pressure - IOP-lowering Surgery||24 months|Eyes, not participants, were analyzed. Eyes with prevalent complications or missing data at enrollment were were excluded from the risk set.||percentage of eyes with uveitis at risk|Participants|95% Confidence Interval|Number
708379|NCT00131508|Secondary|Change in Quality of Life Measures From Baseline to 12 Months.Scores for Each Subcategory Range From 0 (Best) to 4 (Worst).This is True for Both Patient and Parent Reports.|Evaluation of quality of life at baseline and 12 months in the glutamine versus placebo group using the PedsQL Version 4.0 inventory. This instrument measures individual well being across physical, emotional, social, and school function categories using patient self-reports and/or parent reports. The tool contains a 15-question, age-specific, self-report inventory (for children age 5-7 years, 8-12 years, and 13-18 years) and a corresponding parent inventory. Lower scores indicate a better quality of life.|Baseline and 12 Months|||Units on a scale||Full Range|Median
708380|NCT00131508|Secondary|Change in Red Blood Cell Glutamine From Baseline to 12 Months|To investigate the effect of oral glutamine and placebo in children with Sickle Cell Anemia (SCA) by comparing the difference in the levels of red blood cell glutamine between baseline and 12 months of treatment in the two groups.|Baseline and 12 months|||nmol/mg creatinine||Full Range|Median
708381|NCT00131508|Secondary|Change in Body Mass Index From Baseline to 12 Months|To investigate the effect of oral glutamine and placebo on body composition in children with SCA by comparing the difference in body mass indexes (BMI) between baseline and 12 months of treatment in the two groups.|Baseline and 12 months|||kg/m2||Full Range|Median
708382|NCT00131508|Primary|Change in Resting Energy Expenditure From Baseline to 12 Months|To compare the effect of glutamine and placebo on resting energy expenditure (REE) in children with sickle cell anemia (SCA) by comparing the change in REE ratio between baseline and 12 months. REE was measured by indirect calorimetry, using a metabolic cart.REE Ratio =(REE Measured/REE Predicted)x 100).Change was defined as 12 Month REE Ratio minus Baseline REE Ratio.The REE Ratio was evaluated at baseline and 12 months.The REE Ratio is calculated as (REE Measured / REE Predicted) x 100).REE units are measured as (Kcal / day).Change was defined as 12 Month REE Ratio minus Baseline REE Ratio.|Baseline and 12 months|||REE ratio||Full Range|Median
708383|NCT00131573|Primary|Freedom From Major Complications||5 years|||Number of Adverse Events|||Number
708384|NCT00131573|Primary|Average Number of Voids Per Day||12 months|||Average Number of Voids||Standard Deviation|Median
708385|NCT00131664|Secondary|Mean Change From Baseline in Adiponectin at Month 12|Change from baseline was calculated as the Month 12 value minus the baseline value, with LOCF from Month 6. Adiponectin was only done at baseline, months 6 and 12. The test was optional and performed only by participating sites.|Baseline and Month 12|Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline and Month 12 were analyzed.||µg/mL||Standard Error|Mean
708386|NCT00131664|Secondary|Mean Change From Baseline in Adiponectin at Month 6|Change from baseline was calculated as the Month 6 value minus the baseline value. LOCF was not used for this analysis. Adiponectin was only done at baseline, months 6 and 12. The test was optional and performed only by participating sites.|Baseline and Month 6|Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline and Month 6 were analyzed.||microgram per millilitre (µg/mL)||Standard Error|Mean
708387|NCT00131664|Secondary|Mean Change From Baseline in C-reactive Protein (CRP) at Month 12|Change from baseline was calculated as the Month 12 value minus the baseline value, with LOCF from Month 6. CRP was only done at baseline, months 6 and 12. The test was optional and performed only by participating sites.|Baseline and Month 12|Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline and Month 12 were analyzed.||mg/dL||Standard Deviation|Mean
708388|NCT00131664|Secondary|Mean Change From Baseline in C-reactive Protein (CRP) at Month 6|Change from baseline was calculated as the Month 6 value minus the baseline value. LOCF was not used for this analysis. CRP was only done at baseline, months 6 and 8. The test was optional and performed only by participating sites.|Baseline and Month 6|All Primary and secondary endpoints were calculated on the Intent to Treat (ITT) population where each patient had at least one dose of the medication and at least one valid observation. Missing values were carried forward (using Last Observation Carried Forward method) except for the calculation of the composite variables.||milligram per decilitre (mg/dL)||Standard Error|Mean
708389|NCT00131664|Secondary|Mean Change From Baseline in 5 Year UKPDS Risk Scores at Month 12|"Change from baseline was calculated as the Month 12 value minus the baseline value, with LOCF from Month 2. The UKPDS (U.K. Prospective Diabetes Study) risk engine calculated was based on 5 years risk using gender, race, age at diagnosis of diabetes, duration of diabetes, smoking status, A1C, systolic blood pressure and total cholesterol to HDL ratio at a specified visit.
The UKPDS cardiovascular disease (CVD) risk engine is used to estimate the risk of having coronary heart disease in type II diabetes according to the UKPDS model. The possible risk scores can range from 0 to 100% and hence lower scores would predict a person is less likely to have an event."|Baseline and Month 12|Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline and Month 12 were analyzed.||percent||Standard Error|Mean
708390|NCT00131664|Secondary|Mean Change From Baseline in 5 Year UKPDS Risk Scores at Month 6|"Change from baseline was calculated as the Month 6 value minus the baseline value, with LOCF from Month 2. The UKPDS (United Kingdom Prospective Diabetes Study) risk engine calculated was based on 5 years risk using gender, race, age at diagnosis of diabetes, duration of diabetes, smoking status, A1C, systolic blood pressure and total cholesterol to high-density lipoprotein (HDL) ratio at a specified visit.
The UKPDS cardiovascular disease (CVD) risk engine is used to estimate the risk of having coronary heart disease in type II diabetes according to the UKPDS model. The possible risk scores can range from 0 to 100% and hence lower scores would predict a person is less likely to have an event."|Baseline and Month 6|Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline and Month 6 were analyzed.||percent||Standard Error|Mean
708391|NCT00131664|Secondary|Number of Subjects Achieving FPG Target at Month 12|FPG responders were described as subjects having achieved FPG less than 7 mmol/L at Month 12 with LOCF from Month 2.|Month 12|Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline and Month 6 were analyzed.||participants|||Number
708392|NCT00131664|Secondary|Number of Subjects Achieving FPG Target at Month 6|FPG responders were described as subjects having achieved FPG less than 7 mmol/L at Month 6 with LOCF from Month 2.|Month 6|Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline and Month 6 were analyzed.||participants|||Number
708393|NCT00131664|Secondary|Number of Subjects Achieving FPG Target at Month 4|FPG responders were described as subjects having achieved FPG less than 7 mmol/L at Month 4 with LOCF from Month 2.|Month 4|Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline and Month 4 were analyzed.||participants|||Number
708394|NCT00131664|Secondary|Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Month 12|Change from baseline was calculated as the Month 12 value minus the baseline value, with LOCF from Month 2 for withdrawn subjects or missing values.|Baseline and Month 12|Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline and Month 6 were analyzed.||millimoles per litre (mmol/L)||Standard Error|Mean
708395|NCT00131664|Secondary|Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Month 6|Change from baseline was calculated as the Month 6 value minus the baseline value, with last on-treatment observation carried forward (LOCF) from Month 2 for withdrawn subjects or missing values.|Baseline and Month 6|Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline and Month 6 were analyzed.||millimoles per litre (mmol/L)||Standard Error|Mean
708396|NCT00131664|Secondary|Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Month 4|Change from baseline was calculated as the Month 4 value minus the baseline value, with last on-treatment observation carried forward (LOCF) from Month 2 for withdrawn subjects or missing values.|Baseline and Month 4|Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline and Month 4 were analyzed.||millimoles per litre (mmol/L)||Standard Error|Mean
708397|NCT00131664|Secondary|Number of Subjects Achieving A1C Target at Month 12|A1C responders were described as subjects having achieved A1C less than 7 percent at Month 12 with LOCF from Month 2.|Month 12|Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline and Month 12 were analyzed.||participants|||Number
708398|NCT00131664|Secondary|Number of Subjects Achieving A1C Target at Month 6|A1C responders were described as subjects having achieved A1C less than 7 percent at Month 6, with LOCF from Month 2.|Month 6|Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline Month 6 were analyzed.||participants|||Number
708399|NCT00131664|Secondary|Number of Subjects Achieving A1C Target at Month 4|A1C responders were described as subjects having achieved A1C less than 7 percent at Month 4, with LOCF from Month 2.|Month 4|Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline and Month 4 were analyzed.||participants|||Number
708400|NCT00131664|Secondary|Mean Change From Baseline in A1C at Month 12|Change from baseline was calculated as the Month 12 value minus the baseline value, with last on-treatment observation carried forward (LOCF) from Month 2 for withdrawn subjects or missing values.|Baseline and Month 12|Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline and Month 12 were analyzed.||percent||Standard Error|Mean
708401|NCT00131664|Secondary|Mean Change From Baseline in A1C at Month 4|Change from baseline was calculated as the Month 4 value minus the baseline value, with last on-treatment observation carried forward (LOCF) from Month 2 for withdrawn subjects or missing values.|Baseline and Month 4|Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline and Month 4 were analyzed.||percent||Standard Error|Mean
708402|NCT00131664|Primary|Mean Change From Baseline in A1C at Month 6|Change from baseline was calculated as the Month 6 value minus the baseline value, with last on-treatment observation carried forward (LOCF) from Month 2 for withdrawn subjects or missing values.|Baseline and Month 6|Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with a value at baseline and at Month 6 were analyzed.||percent||Standard Error|Mean
708498|NCT00136916|Secondary|Total Daily Long-acting Insulin (Adjusted for Body Weight)|Total daily dose of long-acting insulin adjusted for body weight (units per kilogram [kg]). Long-acting (units) insulin for inhaled insulin and subcutaneous treatment groups included NPH insulin, Ultralente®, and insulin glargine.|Month 3 through extension Month 36|FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.||units/kg||Standard Deviation|Mean
708403|NCT00131677|Other Pre-specified|>5% Bone Mineral Density Decline at Femoral Neck|Percent of San Francisco participants in the TDF vs. placebo groups who were found to have >5% decline in Bone Mineral Density at the femoral neck.|24 months (immediate arm), 15 months (delayed arm)|For biomedical outcomes, a treatment emergent cohort was defined which included only those participants who received study drug. In addition, this analysis population includes only those participants for whom bone density analyses were performed.||percentage of participants|||Number
708404|NCT00131677|Primary|Clinical Safety--Hypophosphatemia|Grade 3 or 4 hypophosphatemia (per National Institutes of Health Division of AIDS toxicity scale)|24 months (immediate arm), 15 months (delayed arm)|For biomedical outcomes, a treatment emergent cohort was defined which included only those participants who received study drug.||participants|||Number
708405|NCT00131677|Secondary|Behavioral Safety--Unprotected Anal Sex (UAS)|Change in percent of participants reporting unprotected anal intercourse--baseline vs. months 3 through 9 on study.|Nine months|||percentage of ppts reporting UAS|||Number
708406|NCT00131677|Secondary|Adherence to Study Drug|Estimated exposure to study drug (active and placebo) as assessed by Medication Event Monitoring System (MEMS) caps.|24 months (immediate arm) and 15 months (delayed arm)|||percentage of doses|||Number
708407|NCT00131677|Secondary|Number of Breakthrough HIV Infections|Number of participants with HIV seroconversions occuring while on study drug|24 months (immediate arm) and 15 months (delayed arm)|For biomedical outcomes, a treatment emergent cohort was defined which included only those participants who received study drug.||participants|||Number
708408|NCT00131677|Primary|Clinical Safety--Creatinine Elevations|Grade 3 or 4 Creatinine elevations (per National Institutes of Health Division of AIDS toxicity scale)|24 months (immediate arm) and 15 months (delayed arm)|For biomedical outcomes, a treatment emergent cohort was defined. Participants entered the TE cohort with first dispense and exited with the first occurrence of: (1) completion of follow-up, (2) 30 days after permanent drug interruption, or (3) 30 days after last visit. For delayed arm participants,time before initiation of drug was excluded.||Participants|||Number
708409|NCT00131885|Secondary|Mean Levels of Luteinizing Hormone, Drawn at Weekly Intervals Until Next Menses|"Descriptive reporting of secondary outcomes of reproductive hormone levels (including FSH, E2, LH).
Pharmacokinetic studies were done between Days 9-12 of the menstrual cycle at Time 1 (baseline, before any treatment with herb or placebo), and at Time 2 (intervention, after treatment with herb or placebo).
Weekly means are reported for both time periods at week 0 (day of pharmacokinetic study), week 1 (one week after pharmacokinetic study) and week 2 (2 weeks after pharmacokinetic study)."|Time Frame: Time 1 (pre-intervention baseline) and Time 2 (following a 6 week intervention)|||IU/mL||Standard Deviation|Mean
708410|NCT00131885|Secondary|Mean Levels of Estradiol-17b (E2) Drawn at Weekly Intervals Until Next Menses|"Descriptive reporting of secondary outcomes of reproductive hormone levels (including FSH, E2, LH).
Pharmacokinetic studies were done between Days 9-12 of the menstrual cycle at Time 1 (baseline, before any treatment with herb or placebo), and at Time 2 (intervention, after treatment with herb or placebo).
Weekly means are reported for both time periods at week 0 (day of pharmacokinetic study), week 1 (one week after pharmacokinetic study) and week 2 (2 weeks after pharmacokinetic study)."|Time Frame: Time 1 (pre-intervention baseline) and Time 2 (following a 6 week intervention)|||pg/mL||Standard Deviation|Mean
708411|NCT00131885|Primary|Clearance (L/hr) of Levonorgestrel Over 24 Hours for Each Dosage Group and Each Study Session.|Average and standard deviation for Clearance (L/hr) of Levonorgestrel study for each dosage group and each study session.|Time Frame: Time 1 (pre-intervention baseline) and Time 2 (following a 6 week intervention)|||L/hr||Standard Deviation|Mean
708412|NCT00131885|Secondary|Mean Levels of Follicle-stimulating Hormone Drawn at Weekly Intervals Until Next Menses|"Descriptive reporting of secondary outcomes of reproductive hormone levels (including FSH, E2, LH).
Pharmacokinetic studies were done between Days 9-12 of the menstrual cycle at Time 1 (baseline, before any treatment with herb or placebo), and at Time 2 (intervention, after treatment with herb or placebo).
Weekly means are reported for both time periods at week 0 (day of pharmacokinetic study), week 1 (one week after pharmacokinetic study) and week 2 (2 weeks after pharmacokinetic study)."|Time Frame: Time 1 (pre-intervention baseline) and Time 2 (following a 6 week intervention)|||IU/mL||Standard Deviation|Mean
708413|NCT00131885|Primary|Number of Participants With Progesterone Levels Above 3.0 ng/ml at Time 1 (Baseline) and Time 2 (After Intervention With St John's Wort or Placebo).|"Serum progesterone levels were drawn at the time of dosing with levonorgestrel and then at weekly intervals until menses occurred. This was done at Time 1 (baseline), and again at Time 2 (after 5 weeks of dosing with St. John's Wort or placebo).
Possible ovulation was defined as a serum progesterone >3ng/ml within 2 weeks of Days 9-12 of the menstrual cycle."|Progesterone levels drawn at weekly intervals after dosing with levonorgestrel between Days 9 and 12 of the menstrual cycle, at each time point until menses|||Participants|||Number
708414|NCT00131885|Primary|Area Under the Concentration Versus Time Curve for 0 to 24 Hours After Drug Administration, Done Between Days 9 and 12 of the Menstrual Cycle at Time 1 (Before) and Time 2 (During Treatment With St. John's Wort or Placebo)|"Pharmacokinetic studies were done between Days 9-12 of the menstrual cycle at Time 1 (baseline, before any treatment with herb or placebo), and at Time 2 (intervention, after treatment with herb or placebo). Serum samples drawn at 0, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, and 24 hours, following oral administration of a dose of levonorgestrel.
Treatment between the two time periods was with St. John's Wort or placebo herb, beginning after the Time 1 (baseline) and continued for 5 weeks until Time 2.
Estimates of levonorgestrel clearance were made using a two stage non-compartmental approach to determine individual and group parameters."|Area Under the Concentration versus Time curve for 0 to 24 hours after drug administration, between Days 9 and 12 of the menstrual cycle, done at Time 1 and at Time 2|||ng*hr/mL||Standard Deviation|Mean
708415|NCT00131911|Secondary|Duration of Response|Duration of response (DOR) was defined as the time from attaining a response (PR or CR) to the date of progression. Participants without progression were censored at the date of their most recent disease assessment. The median DOR was estimated using simple summary statistics.|Time from response to progression (up to 2 years)|There were 4 confirmed responses in Group A and 5 confirmed responses in Group B used in analyzing this endpoint.||months||Full Range|Median
708758|NCT00144170|Secondary|Virologic Response at Week 8|Virologic response defined as Viral Load<50 copies/mL|Week 8|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
708416|NCT00131911|Secondary|Progression Free Survival|Progression was defined using Response Evaluation Criteria In Solid Tumors (RECIST) as a 20% increase in the su of longest diameter of target lesions. Progression free survival (PFS) was defined as the time from registration to progression or death of any cause. Participants who were progression free were censored at the date of their most recent disease assessment. The median PFS with 95% CI was estimated using the Kaplan Meier method.|Time from registration to progression or death (up to 2 years)|||months||95% Confidence Interval|Median
708417|NCT00131911|Secondary|Overall Survival|Overall survival (OS) was defined as the time from registration to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% CI was estimated using the Kaplan Meier method.|From registration to death (up to 2 years)|||months||95% Confidence Interval|Median
708418|NCT00131911|Secondary|Toxicity|For this secondary endpoint, toxicity is defined as a grade 3 or higher adverse events that is classified as either possibly, probably, or definitely related to study treatment. The assignment of attribution to study treatment and grade (or degree of severity) of the adverse event are classified using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The number of participants reporting a grade 3 or higher toxicity are reported.|Up to 2 years|||participants|||Number
708419|NCT00131911|Primary|Confirmed Response Rate|"Confirmed response rate was defined using Response Evaluation Criteria In Solid Tumors (RECIST). A confirmed response is defined as a complete response (CR) or partial response (PR) observed on subsequent scans at least 4 weeks apart. Confirmed response rate was estimated by the number of successes divided by the total number of evaluable patients. > > Complete Response (CR) is defined as the disappearance of all target lesions. > Partial Response (PR) is defined as a 30% decrease in sum of longest diameter of target lesions; >
> We report the percentage of patients with a confirmed response and a 95% confidence interval estimated by the Duffy and Santner method."|Duration of Treatment (Up to 2 years)|Nine of the 50 carcinoid patients and 6 of the 42 Islet cell patients did not continue treatment past cycle 1. Therefore, these patients were not evaluated on consecutive cycles and were excluded from this endpoint.||percentage of participants||95% Confidence Interval|Number
708420|NCT00131937|Secondary|Overall Survival|Overall survival is defined as the time from study entry until death from any cause.|Assessed after month 2 and month 6, then every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-3 years from study entry, up to 3 years.|||months||90% Confidence Interval|Median
708421|NCT00131937|Secondary|Progression-Free Survival (PFS)|"PFS is defined as the time from randomization to the first of progression, relapse or death from any cause. Per criteria from International Workshop to Standardize Criteria for NHL (Cheson, 1999), progression (for patients who have not responded) and relapse (for patients who responded) are defined as:
Appearances of any new lesions/sites during or after therapy
Increase of ≥50% in the SPD from nadir measurement of all involved dominant lymph nodes and liver/spleen nodules or unequivocal progression in any nonmeasurable disease or nondominant site
Increase by ≥50% in greatest diameter from nadir measurement of any previously involved dominant node >1.0 cm in its short axis"|Assessed after month 2 and month 6, then every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-3 years from study entry, up to 3 years|||months||90% Confidence Interval|Median
708422|NCT00131937|Primary|Overall Response (OR) Rate|"Response was assessed using the criteria from International Workshop to Standardize Criteria for NHL (Cheson, 1999). OR=complete response(CR)+complete response/uncertain(CRu)+partial response(PR) CR: 1)Disappearance of clinical/radiographic evidence of disease (dz) and all dz-related B-symptoms; normalization of biochemical abnormalities attributed to NHL; 2)Lymph nodes and nodal masses regress to normal size; 3)Spleen, if enlarged before therapy, has decreased in size and is not palpable; 4)Complete resolution of lymphoma in bone marrow biopsy CRu: Meet criteria 1 and 3 above but with ≥1 of the followings. Residual dominant nodal mass >1.5 cm in greatest diameter that has decreased by >75%. Indeterminate bone marrow.
PR: ≥50% decrease in SPD (sum of products of diameters) of 6 largest dominant nodes or nodal masses. No increase in size of liver or spleen. No unequivocal progression in nonmeasurable or nondominant sites. Splenic/hepatic nodules regress ≥50% in SPD. No new dz sites."|Assessed at the end of Cycle 2 and Cycle 6 (1 cycle = 28 days). Then every 3 months beginning Cycle 9 if patient is < 2 years from study entry, every 6 months if patient is 2-3 years from study entry, up to 3 years.|||Proportion of participants||90% Confidence Interval|Number
708423|NCT00132002|Secondary|Progression-free Survival|Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|From start of treatment to the time of documented progression, assessed up to 5 years|||Months||95% Confidence Interval|Median
708424|NCT00132002|Secondary|Overall Survival|Estimated using the product-limit method of Kaplan and Meier.|From the initial date of treatment to time of death, up to 5 years.|||Months||95% Confidence Interval|Median
708425|NCT00132002|Primary|Objective Tumor Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Up to 8 weeks|||percentage of participants|||Number
708426|NCT00132028|Secondary|Overall Survival|Measured from date of registration to death, or last contact date|after every 3 cycles on treatment, then every 6 months for 2 years, then annually for a total of 5 years.|All eligible patients who started treatment were included in assessing overall survival.||months||95% Confidence Interval|Median
708427|NCT00132028|Secondary|Progression-Free Survival|Measured from date of registration to date of first observation of progression or death, or last contact date. Progression is defined as a 50% increase in sum of products of greatest diameters (SPD) of target measurable lesions over the smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline; appearance of a new lesion/site; unequivocal progression of non-measurable disease in the opinion of the treating physician; death due to disease without prior documentation of progression.|after every 3 cycles on treatment, then every 6 months for 2 years, then annually for a total of 5 years.|All eligible patients who started treatment were included in assessing progression-free survival.||months||95% Confidence Interval|Median
733993|NCT00424190|Primary|Clinical Cure Rate of Ceftaroline Compared With That of Vancomycin Plus Aztreonam Treatment at TOC in the Clinically Evaluable (CE) Population||8-15 days after last dose of study drug||||||
708428|NCT00132028|Primary|Assess Number of Patients Who Achieve Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR)|Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the SPD for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.|after every 3 cycles on treatment|All patients who started treatment were included in assessing response estimates.||participants|||Number
708429|NCT00132132|Primary|Percentage of Participants With BMI Reduction||Baseline, 12-15 months|Per protocol||percentage of participants|||Number
708430|NCT00132132|Primary|Change in BMI (Body Mass Index)||Baseline, 12-15 months|Per protocol analysis: subjects who attended at least one intervention session in addition to their final assessment||kg/m^2||95% Confidence Interval|Mean
708431|NCT00132314|Primary|Hazard Ratio for Hospitalization|Hazard ratio of LAI versus Oral for psychiatric hospitalization (in both VA and non-VA hospitals), after randomization up to 24 months, obtained from a Cox proportional hazards model.|24 months|||participants|||Number
708432|NCT00132314|Primary|Hospitalization-free Survival - Time to Event|A hospitalization-free survival was defined as the time from the date of randomization to the time of a psychiatric hospitalization (in both VA and non-VA hospitals) or, in the case of patients who were hospitalized at randomization, the time from the date of discharge from the initial stay to subsequent hospitalization. Patients without an event were censored at 24 months after the date of randomization.|From randomization until date of first re-hospitalization, assessed up to 24 months|||years||95% Confidence Interval|Median
708433|NCT00132496|Primary|Treatment-emergent Adverse Events Experienced by >=5% of Patients in Any Treatment Group|Primary safety outcomes include adverse events, physical examinations and clinical laboratory results. AE results are presented in the table.|8 weeks from randomization and end of treatment|Safety population (all patients who received at least one dose of study treatment) was the primary analysis population.||Participants|||Number
708434|NCT00132678|Secondary|Change in Montgomery-Åsberg Depression Rating Scale (MADRS)|Measure of depression; score range 0 to 60 (lower score = less severity)|Baseline and Endpoint (last observation carried forward) of 24 month Double-Blind Period IV|Restricted to subjects with paired baseline and visit endpoint (Period IV) data only. Endpoint is the patient’s last nonmissing, postbaseline value in Period IV (last observation carried forward technique)||units on a scale||Standard Deviation|Mean
708435|NCT00132678|Secondary|Change in Young Mania Rating Scale (YMRS) Scores.|Measure of mania; score range 0 to 60 (lower score = less severity)|Baseline and Endpoint (last observation carried forward) of 24 month Double-Blind Period IV|Restricted to subjects with paired baseline and visit endpoint (Period IV) data only. Endpoint is the patient’s last nonmissing, postbaseline value in Period IV (last observation carried forward technique)||units on a scale||Standard Deviation|Mean
708436|NCT00132678|Primary|Number of Participants Who Had a Mood Relapse.|"Mood Relapse was defined as:
The subject met DSM-IV criteria for a manic, hypomanic, mixed, or depressive episode; or, the subject needed treatment intervention with any mood stabilizer, antipsychotic medication (other than study drug), benzodiazepine (beyond the dosage allowed), or antidepressant medication; or the subject required hospitalization for any bipolar mood episode; or the subject had a YMRS or MADRS score >12 or a CGI-S score >4; or a dose increase, or supplementation with oral risperidone or another antipsychotic or mood stabilizer, was needed in the opinion of the investigator."|24 months|Intention to treat. 28 subjects from a Good Clinical Practice noncompliant site and 1 site with alleged research misconduct were excluded from efficacy analyses. The median (interquartile range) for time to relapse (d): Risperdal Consta: NA (173, NA) & Placebo: 219 (82, NA) [NA = not available; Risperdal Consta relapse percent < 50% & Placebo <75%]||Participants|||Number
708437|NCT00132691|Secondary|Mortality||24 months|||percentage of participants||95% Confidence Interval|Number
708438|NCT00132691|Secondary|Diabetes Mellitus||24 months|Participants with prevalent complications or missing data at enrollment were excluded from the risk set.||percentage of participants||95% Confidence Interval|Number
708439|NCT00132691|Secondary|Hypertension Diagnosis Requiring Treatment||24 months|Participants with prevalent complications or missing data at enrollment were excluded from the risk set.||percentage of participants||95% Confidence Interval|Number
708440|NCT00132691|Secondary|Hyperlipidemia - Incident|LDL greater than or equal to 160 mg/mL|24 months|Number of participants at risk were included in the analysis||percentage of participants at risk||95% Confidence Interval|Number
708441|NCT00132691|Secondary|Change in SF-36 Physical Component Score From Baseline to 24 Months|Self-reported health related QoL was measured with the SF 36 survey. The physical component score for the SF 36 is a summary measure of physical health primarily based on the physical functioning, role physical, bodily pain and general health domains of the survey. The score is scaled to a population norm with a mean of 50 and standard deviation of 10. Higher scores represent better outcomes. The mean change in scores between baseline and 24 months was calculated for each treatment group. A 3 to 5 point difference is considered to be clinically meaningful.|24 months|||units on a scale||Standard Error|Mean
708442|NCT00132691|Secondary|Change in SF-36 Mental Component Score From Baseline to 24 Months|Self-reported health related QoL was measured with the SF 36 survey. The mental component score for the SF 36 is a summary measure of mental health primarily based on the social functioning, role emotional, mental health and vitality domains. The score is scaled to a population norm with a mean of 50 and standard deviation of 10. Higher scores represent better outcomes. The mean change in scores between baseline and 24 months was calculated for each treatment group.|24 months|||units on a scale||Standard Error|Mean
708443|NCT00132691|Secondary|Change in Self-reported Vision-related Function as Measured by the National Eye Institute 25-Item Visual Function Questionnaire (NEI-VFQ 25) Vision Targeted Composite Score From Baseline to 24 Months|The NEI-VFQ 25 measures the effect of visual disability/symptoms with generic health and task-oriented domains. The range for the composite score is 0 to 100; higher scores are associated with better visual function. A change of 4 to 6 points is considered to be a clinically meaningful difference.|24 months|||units on a scale (composite score)||Standard Error|Mean
734191|NCT00424827|Secondary|Biomarker Response to Chemoradiation Therapy|20% decrease in biomarker (CA19-9) from baseline|1-year|Biomarker response (CA19-9) as defined by at least a 20% decrease from baseline||participants|||Number
708446|NCT00132691|Secondary|Intraocular Pressure (IOP) - Incident Use of IOP-lowering Medical Therapy (Percentage of Eyes With Uveitis That Were Not Being Treated With IOP-lowering Medical Therapy at Baseline and Underwent IOP Lowering Therapy During the 24 Month Follow-up.|The percentage of subjects who used topical or systemic treatment for elevated IOP at any time during the 2 year follow-up and were not on IOP-lowering therapy at baseline is reported.|24 months|Eyes, not participants, were analyzed. Eyes with prevalent complications or missing data at enrollment were were excluded from the risk set.||percentage of eyes with uveitis at risk|Participants|95% Confidence Interval|Number
708447|NCT00132691|Secondary|Glaucoma - Incident|Glaucoma was diagnosed by a glaucoma specialist through review of visual fields, clinical data, and fundus images.|24 months|Eyes, not participants, were analyzed. Eyes with prevalent complications or missing data at enrollment were were excluded from the risk set.||percentage of eyes with uveitis at risk|Participants|95% Confidence Interval|Number
708448|NCT00132691|Secondary|Intraocular Pressure - Incident IOP Elevation >= 10 mmHg Above Baseline||24 months|Eyes, not participants, were analyzed. Eyes with prevalent complications or missing data at enrollment were were excluded from the risk set.||percentage of eyes with uveitis at risk|Participants|95% Confidence Interval|Number
708449|NCT00132691|Secondary|Intraocular Pressure - Incident IOP Greater Than or Equal to 24 mm Hg||24 months|Eyes, not participants, were analyzed. Eyes with prevalent complications or missing data at enrollment were were excluded from the risk set.||percentage of eyes with uveitis at risk|Participants|95% Confidence Interval|Number
708450|NCT00132691|Secondary|Intraocular Pressure - Incident IOP Greater Than or Equal to 30 mm Hg||24 months|Eyes, not participants, were analyzed. Eyes with prevalent complications or missing data at enrollment were were excluded from the risk set.||percentage of eyes with uveitis at risk|Participants|95% Confidence Interval|Number
708451|NCT00132691|Secondary|Uveitis Activity|Uveitis activity was determined by clinician assessment at each study visit. The study ophthalmologist evaluated each eye as active, inactive/never had uveitis or cannot assess.|24 months|All eyes with uveitis were included in the analysis (245 eyes of the 129 participants randomized to implant therapy and 234 eyes of the 126 participants randomized to systemic therapy).||percentage of eyes with uveitis|Participants|95% Confidence Interval|Number
708452|NCT00132691|Secondary|Macular Edema|center point macular thickness >= 240 micrometers assessed on OCT (Stratus OCT-3 [Carl Zeiss Meditec, Dublin, CA]) as graded by Central Reading Center|24 months|All eyes with uveitis were included in the analysis (245 eyes of the 129 participants randomized to implant therapy and 234 eyes of the 126 participants randomized to systemic therapy)..||percentage of eyes with uveitis|Participants|95% Confidence Interval|Number
708453|NCT00132691|Primary|Change in Best-corrected Visual Acuity (Change in the Numbers of Letters Read From a Standard ETDRS Eye Chart) From Baseline to 24 Months in Eyes With Uveitis|Best-corrected visual acuity was measured as the number of letters read from standard logarithmic visual acuity charts by study-certified examiners who were masked to treatment. Visual acuity was measured at all study visits. The primary outcome was eye-specific change in visual acuity from baseline to 2-year follow-up. Positive change values indicate improved vision while negative change values indicate vision has gotten worse. A change of 7.5 letters is considered clinically meaningful.|24 months|"The primary analysis was an intention-to-treat analysis; analysis was conducted as randomized. Data from the 255 randomized participants were used in the analytic model. 232 of the 255 completed the 2 year outcome visit."||letters||Standard Error|Mean
708454|NCT00132730|Secondary|Change From Baseline in Predose (Trough) Forced Vital Capacity (FVC)|FVC is a measure, in liters and using a spirometer, of the amount of air forcibly exhaled from the lungs after taking the deepest breath possible. The values averaged during the placebo run-in period were used for the baseline measurement and the values averaged over Treatment Weeks 8, 10 and 12 were used for the on-treatment measurement. A higher value indicates greater lung exiratory function.|Predose at Baseline and Treatment Weeks 8, 10 and 12|The modified ITT population includes all participants who had a baseline and at least one posttreatment measurement.||liters||95% Confidence Interval|Least Squares Mean
708455|NCT00132730|Secondary|Number of Participants With at Least One Chronic Obstructive Pulmonary Disease (COPD) Exacerbation|COPD exacerbation is defined as any change in symptoms or functional status that leads to administration (at investigator's discretion) of systemic corticosteroids (above participant's usual dose) and/or antibiotics, or an unscheduled COPD-related hospitalization, emergency room visit, or doctor visit. The number of participants who experienced at least one COPD exacerbation during the 12-week treatment period is reported.|Baseline through Treatment Week 12|The modified ITT population includes all participants who had a baseline and at least one posttreatment measurement.||participants|||Number
708456|NCT00132730|Secondary|Change From Baseline in Shortness of Breath Questionnaire (SOBQ) Response|The SOBQ is a validated 24-item measure of dyspnea associated with activities of daily living in patients with moderate to severe chronic lung disease. Twenty-one items ask patients about how frequently they experience shortness of breath (SOB) on a 6-point scale of 0 (never) to 5 (activity given up due to dyspnea) when performing various tasks. Three additional questions about limitations due to SOB, fear of harm from overexertion and fear of SOB are included for a total of 24 items. If patients do not routinely perform the activity indicated in the questionnaire, they are asked to estimate the degree of SOB anticipated. The SOBQ total score is calculated by summing responses across all 24 items. The total score ranges from 0 to 120, with a higher score indicating greater frequency of and limitations due to SOB. The score assessed at the baseline visit was used for the baseline score and the mean score assessed at Treatment Weeks 8 and 12 was used as the on-treatment score.|Baseline and Treatment Weeks 8 and 12|The modified ITT population includes all participants who had a baseline and at least one posttreatment measurement.||score on a scale||95% Confidence Interval|Least Squares Mean
708457|NCT00132730|Secondary|Transition Dyspnea Index (TDI) Focal Score|The baseline dyspnea index (BDI) was measured at the randomization visit as a 3-domain score with a scale of 0 to 4 in each domain, with a total focal score of 12 indicating no dyspnea limitation and 0 indicating severe dyspnea. After 12 weeks of treatment, the investigator-administered TDI was completed, with a change in each of the 3 domains being rated from -3 (major deterioration) to +3 (major improvement), so that the TDI focal score could range from -9 to +9. A higher TDI focal score indicates improvement.|Baseline and Treatment Week 12|The modified ITT population includes all participants who had a baseline and at least one posttreatment measurement.||score on a scale||95% Confidence Interval|Least Squares Mean
708458|NCT00132730|Secondary|Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Response|"The SGRQ consists of 76 items in 3 domains: Symptoms (frequency and severity), Activity (activities that cause or are limited by breathlessness) and Impacts (social functioning, psychological disturbances resulting from airways disease). Scores for each domain and a total score are calculated; each questionnaire response has a unique empirically dervied weight. Scores range from 0 to 100, with higher scores indicating poor health. Each domain of the questionnaire is scored separately in 2 steps: 1) The weights for all items with a positive response are summed; 2) The score is calculated by dividing the summed weights by the maximum possible weight for that domain and expressing the results as a percentage. The mean SGRQ scores were calculated during the placebo run-in period for baseline and over the last 4 weeks of the 12-week treatment period for on-treatment."|Baseline and Treatment Weeks 8 and 12|The modified ITT population includes all participants who had a baseline and at least one posttreatment measurement.||score on a scale||95% Confidence Interval|Least Squares Mean
708459|NCT00132730|Secondary|Change From Baseline in Total Daily Beta-agonist Use|The total daily beta-agonist use was measured in puffs per day and was recorded on daily diary cards by participants. It is defined as the sum of beta-agonist use between when participants arose from and went to bed. The total daily beta-agonist use values were the recorded mean during the placebo run-in period for baseline and over the last 4 weeks of the 12-week treatment period for on-treatment.|Baseline and Treatment Weeks 8, 10 and 12|The modified ITT population includes all participants who had a baseline and at least one posttreatment measurement.||Puffs per day of beta-agonist||95% Confidence Interval|Least Squares Mean
708460|NCT00132730|Secondary|Change From Baseline in Overall Daytime Symptoms Score|"On a daily diary card, participants rated their responses to the question Overall, how much of the time did you have symptoms from your lung disease today? (0=none of the time; 5=all of the time). Scores range from 0 to 5, with higher scores indicating more time with symptoms. The overall daytime symptoms score value was the mean daily diary score during the placebo run-in period for baseline and over the last 4 weeks of the 12-week treatment period for on-treatment."|Baseline and Treatment Weeks 8, 10 and 12|The modified ITT population includes all participants who had a baseline and at least one posttreatment measurement.||score on a scale||95% Confidence Interval|Least Squares Mean
708461|NCT00132730|Primary|Change From Baseline in Pre-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1)|FEV1 is a measure, in liters, of the amount of air expired in 1 second. Measured values were averaged during the placebo run-in period for baseline and over the last 4 weeks of the 12-week treatment period for on-treatment. For participants who did not have any measurements over the last 4 weeks of the 12-week treatment period, the last available on-treatment measurement was carried forward.|Pre-dose at Baseline and Treatment Weeks 8, 10 and 12|The modified intention-to-treat (ITT) population includes all participants who had a baseline and at least one posttreatment measurement.||liters||95% Confidence Interval|Least Squares Mean
708462|NCT00132769|Secondary|Ratio of On-treatment C-Reactive Protein to Baseline C-Reactive Protein|C-reactive protein levels rise in response to inflammation in the body. The ratio of On-treatment serum C-reative protein:Baseline serum C-reactive protein was calculated to determine a treatment effect. On-treatment C-reactive protein = the mean of serum C-reactive protein levels for Treatment Weeks 8, 10 and 12. A ratio of less than 1.0 is consistent with lower inflammation and was to be considered an improvement.|Baseline and the average of Treatment Weeks 8, 10 and 12|The APT population consisted of all participants with a baseline and at least one postbaseline observation.||ratio||95% Confidence Interval|Least Squares Mean
708463|NCT00132769|Secondary|Patient's Assessment of Pain|"At each clinic visit, participants were to assess their amount of pain due to arthritis during the previous 48 hours on a 100 mm visual analog scale (VAS) that ranged from No pain (0) to Extreme pain (100). A lower score indicates less pain."|Treatment Week 12|No additional analyses were performed if the primary (Swollen Joint Count) and major secondary (ACR20) outcome measures resulted in a p-value of >0.05.|||||
708464|NCT00132769|Secondary|Health Assessment Questionnaire Disability Index|The Stanford Health Assessment Questionnaire Disability Index assesses participant functional ability based on 20 questions in 8 categories of functioning: dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. Responses range from 0=No disability to 3=Completely disabled. The score for each category subscale is the single response within the category with the highest score (greatest difficulty). The overall score for the Disability Index is the mean of the 8 category scores and also ranges from 0-3, with a lower score indicating less disability.|The average of Treatment Weeks 8, 10 and 12|No additional analyses were performed if the primary (Swollen Joint Count) and major secondary (ACR20) outcome measures resulted in a p-value of >0.05.|||||
708465|NCT00132769|Secondary|Patient Global Assessment of Response to Therapy|Participants were to rate their overall response to the study drug on a 5-point Likert scale with grading as follows: 0=None, 1=Poor, 2=Fair, 3=Good, or 4=Excellent (scale range: 0-4). A higher score indicates a more positive response to study drug.|Treatment Week 12|No additional analyses were performed if the primary (Swollen Joint Count) and major secondary (ACR20) outcome measures resulted in a p-value of >0.05.|||||
708466|NCT00132769|Secondary|Investigator Global Assessment of Disease Activity|At each clinic visit, the Investigator was to make a global assessment of participant disease activity on a 5-point Likert scale with grading as follows: 1=Very well, 2=Well, 3=Fair, 4=Poor, or 5=Very poor (scale range: 1-5). A lower score indicates a more positive assessment of participant disease activity.|Treatment Week 12|No additional analyses were performed if the primary (Swollen Joint Count) and major secondary (ACR20) outcome measures resulted in a p-value of >0.05.|||||
708467|NCT00132769|Secondary|Patient Global Assessment of Disease Activity|"At each clinic visit, participants were to assess disease activity using a 100 mm visual analog scale (VAS) in reponse to the question: “Considering all the ways your arthritis affects you, mark an (X) through the line for how well you are doing.” The VAS ranges from Very Well (0) to Very Poor (100). The mean score at Treatment Weeks 8, 10 and 12 was calculated. A lower score indicates a better disease activity."|The average of Treatment Weeks 8, 10 and 12|No additional analyses were performed if the primary (Swollen Joint Count) and major secondary (ACR20) outcome measures resulted in a p-value of >0.05.|||||
708604|NCT00138125|Primary|Progression-free Survival|Of the two treated patients on this trial, the records show that one patient who received Herceptin only completed 3 cycles of therapy, while the second patient who received Herceptin in combination with Faslodex completed 9 cycles of therapy. The last survival data collected from October to November 2008 showed that these two participants were alive at that time.|5 years|||participants|||Number
708468|NCT00132769|Secondary|Change From Baseline in Tender Joint Count|Tender joint count (TJC) was to be determined by assessing 68 joints (34 right side, 34 left side) for pain using the following grading system: 0=No pain, 1=Patient states that there is pain, 2=Patient states that there is pain and winces, or 3=Patient states that there is pain, winces, and withdraws. The total number of joints graded 1, 2, or 3 were then to be counted to yield the TJC. TJC ranges from 1-68, with increasing score indicating greater number of tender joints. TJC was to be averaged over weeks 8, 10, and 12 to yield a Treatment Period Mean. Change from Baseline = Treatment Period Mean TJC - Baseline TJC.|Baseline and the average of Treatment Weeks 8, 10 and 12|No additional analyses were performed if the primary (Swollen Joint Count) and major secondary (ACR20) outcome measures resulted in a p-value of >0.05.|||||
708469|NCT00132769|Secondary|Percentage of Participants With American College of Rheumatology 20% Response [ACR20]|Participants were categorized as meeting ACR20 criteria when they had at least 20% improvement from Baseline in tender and swollen joint counts, and improvement from Baseline in at least 3 of 5 of the following domains: Pain Visual Analog Scale (VAS), Patient Global Assessement, Physician Global Assessment, Patient Physical Function (Disability) Score and acute-phase reactant (Erythrocyte Sedimentation Rate [ESR] or C-Reactive Protein [CRP]). The average percentage of participants that met the ACR20 responder criteria over Treatment Weeks 8, 10 and 12 was calculated.|Baseline and the average of Treatment Weeks 8, 10 and 12|The APT population consisted of all participants with a baseline and at least one postbaseline observation.||percentage of participants|||Number
708470|NCT00132769|Primary|Change From Baseline in Swollen Joint Count|Swollen joint count (SJC) was determined by assessing 66 joints (33 right side, 33 left side) for swelling using the following grading system: 0=Absent, 1=Detectable synovial thickening without loss of bony contours, 2=Loss of distinctiveness of bony contours, or 3=Bulging synovial proliferation with cystic characteristics. The total number of joints graded 1, 2, or 3 were then counted to yield the SJC. SJC ranged from 1-66, with increasing score indicating greater number of swollen joints. SJC was averaged over weeks 8, 10 and 12 to yield a Treatment Period Mean. Change from Baseline = Treatment Period Mean SJC - Baseline SJC.|Baseline and the average of Treatment Weeks 8, 10 and 12|The All Patients Treated (APT) population consisted of all participants with a baseline and at least one postbaseline observation.||score on a scale||95% Confidence Interval|Least Squares Mean
708471|NCT00132808|Secondary|Biochemical Marker of Bone Formation: Bone Serum Alkaline Phosphatase (BSAP), by Stratum|Biomarker: BSAP levels at Months 6, 12, 18 and 24 by stratum.|Months 6, 12, 18 and 24|Intent to treat population with available data.||ng/mL||Standard Deviation|Mean
708472|NCT00132808|Secondary|Biochemical Marker of Bone Formation: Serum N-terminal Propeptide of Type 1 Collagen (P1NP), by Stratum|Biomarker: Serum P1NP levels at Months 6, 12, 18 and 24 by stratum.|Months 6, 12, 18 and 24|Intent to treat population with available data.||ng/mL||Standard Deviation|Mean
708473|NCT00132808|Secondary|Biochemical Marker of Bone Resorption: Serum Beta C-telopeptides (b-CTx), by Stratum|Biomarker: Serum b-CTx levels at Months 6, 12, 18 and 24 by stratum.|Months 6, 12, 18 and 24|Intent to treat population with available data.||ng/mL||Standard Deviation|Mean
708474|NCT00132808|Secondary|Percentage Change in Femoral Neck BMD at Month 24 Relative to Baseline, by Stratum.|The percentage change in femoral neck BMD at Month 24 relative to baseline was derived as 100 x (femoral neck BMD at 24 Month - femoral neck BMD at baseline) / (femoral neck BMD at baseline).|Baseline, Month 24|Intent to treat population with available data.||Percentage change in BMD||Standard Error|Least Squares Mean
708475|NCT00132808|Secondary|Percentage Change in Total Hip BMD at Month 24 Relative to Baseline, by Stratum.|The percentage change in total hip BMD at Month 24 relative to baseline was derived as 100 x (total hip BMD at 24 Month - total hip BMD at baseline) / (total hip BMD at baseline).|Baseline, Month 24|Intent to treat population with available data.||Percentage change in BMD||Standard Error|Least Squares Mean
708476|NCT00132808|Primary|Percentage Change in Lumbar Spine Bone Mineral Density (BMD) at Month 24 Relative to Baseline, by Stratum|The percentage change in lumbar spine BMD at Month 24 relative to baseline was derived as 100 x (lumbar spine BMD at 24 Month – lumbar spine BMD at baseline) / (lumbar spine BMD at baseline).|Baseline, Month 24|Intent to treat population. Last observation carried forward (LOCF) was utilized to impute missing data.||Percentage change in BMD||Standard Error|Least Squares Mean
708477|NCT00132873|Primary|Vital Signs|Average Respiratory Rate at 1 year.|At 1 year|||Breaths per minute||Standard Deviation|Mean
708478|NCT00132873|Primary|Adverse Experiences|Number of Subjects with treatment-emergent adverse events.|continuous|||participants|||Number
708479|NCT00136695|Primary|Lean Body Mass||1 year|||grams||Standard Deviation|Mean
708480|NCT00136760|Secondary|Cigarettes Smoked Per Day||3 weeks|||cigarettes per day||Standard Deviation|Mean
708481|NCT00136760|Primary|Urinary Cotinine|Urinary Cotinine levels at Week 4 (average of last 3 study visits)|3 weeks|||ng/ml||Standard Deviation|Mean
708482|NCT00136812|Primary|7 Day Point Prevalence of Cigarette Abstinence||3 mo, 6 mo, 12 mo, and 18 mo post-baseline|||% quit||95% Confidence Interval|Number
708483|NCT00136838|Other Pre-specified|Craving|Measure of self-reported craving on a scale of 0-70 (0=no craving; 70= worst possible craving).|immediately following cue expose|||units on a scale (0-70)||Standard Error|Mean
708484|NCT00136838|Primary|Cigarette Choice After 3 Day Abstinence|Following 3 days of abstinence participants had an option to smoke cigarettes every 30 minutes for the maximum of 6 choices|During Day 4 experimental session|||number of cigarette choices (0-6)||Standard Error|Mean
708485|NCT00136916|Secondary|Insulin Antibodies|Observed values for insulin antibodies measured as micro units per milliliter (microU/mL).|Baseline through extension Month 36|FAS; (n)=number of subjects with analyzable data at observation: inhaled insulin/SC insulin, respectively. Insulin antibody levels increased in Exubera®-treated compared to control subjects; results are included to establish there were no safety consequences due to these elevations although this was not an originally specified protocol endpoint.||microU/mL||Full Range|Median
708497|NCT00136916|Secondary|Total Daily Short-acting Insulin Dose (Unadjusted for Body Weight)|Total daily dose of short-acting insulin unadjusted for body weight. Short-acting insulin (milligrams [mg]) for the inhaled insulin treatment group was inhaled insulin; short-acting insulin (units) for the subcutaneous insulin treatment group included insulin lispro, insulin aspart, and regular insulin.|Month 3 through extension Month 36|FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.||mg, units||Standard Deviation|Mean
708486|NCT00136916|Secondary|High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Not Within Normal Limits|"Number of subjects with Yes or No responses (within normal limits at specified time points = Yes or not within normal limits at specified time points = No) at observation when HRCT of thorax was not within normal limits at baseline. No response at observation further categorized as no significant change (NSC), more abnormal (> Abn), or less abnormal (< Abn)."|Baseline, M12, M24, Ext M6, Ext M18, Ext M36|All subjects analysis substudy population: subjects from participating sites with a baseline and subsequent post-baseline HRCT measurement. Subjects were recruited prior to randomization; substudy enrollment continued until at least 50 subjects randomized to inhaled insulin were enrolled or until enrollment in the study was complete.||participants|||Number
708487|NCT00136916|Secondary|High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Within Normal Limits|Number of subjects with Yes or No responses (within normal limits at specified time points = Yes or not within normal limits at specified time points = No) at observation when HRCT of thorax was within normal limits at baseline.|Baseline, M12, M24, Ext M6, Ext M18, Ext M36|All subjects analysis substudy population: subjects from participating sites with a baseline and subsequent post-baseline HRCT measurement. Subjects were recruited prior to randomization; substudy enrollment continued until at least 50 subjects randomized to inhaled insulin were enrolled or until enrollment in the study was complete.||participants|||Number
708488|NCT00136916|Secondary|Transition Dyspnea Index (TDI)|Clinician administered instrument to measure the baseline severity of breathlessness (shortness of breath) in symptomatic patients with 3 domains: functional impairment, magnitude of task, and magnitude of effort. TDI score range -3 (major deterioration) to +3 (major improvement); sum of all domains yields the TDI focal score (–9 to +9); lower score indicates greater deterioration. Compared to previous scoring to determine deterioration or improvement.|Week 4 through extension follow up Month 3 or end of study|FAS FEV1. Due to early termination of study a limited set of analyses were undertaken and results of TDI were not summarized as planned.||scores on scale|||Number
708489|NCT00136916|Secondary|Baseline Dyspnea Index (BDI)|Clinician administered instrument to measure the baseline severity of breathlessness (shortness of breath) in symptomatic patients with 3 domains: functional impairment, magnitude of task, and magnitude of effort. BDI score range 0 (very severe impairment) to 4 (no impairment) scaled to a BDI focal score (0–12). Lower score indicates greater impairment.|Week -1|FAS FEV1. Due to early termination of study a limited set of analyses were undertaken and results of BDI were not summarized as planned.||scores on scale|||Number
708490|NCT00136916|Secondary|Cough Questionnaire|Clinician administered 6 question instrument to measure cough frequency (night, day), severity, timing in relation to short-acting insulin dosing, severity related to insulin dosing (SC or inhaled), and productivity of cough; range 0 (indicates no symptoms) to 4 (indicates severe symptoms). Questionnaire administered at Week 0 then if and only if, cough is identified as an adverse event not explained by a concomitant condition, such as an upper respiratory tract infection.|Week 0 and if indicated through extension follow up Month 3|FAS. Due to early termination of study a limited set of analyses were undertaken and results of Cough Questionnaire were not summarized as planned.||scores on scale|||Number
708491|NCT00136916|Secondary|Severe Hypoglycemic Event Rates|Severe hypoglycemic event rate; all 3 criteria were met: subject unable to treat self, exhibited at least 1 neurological symptom (memory loss, confusion, uncontrollable behavior, irrational behavior, unusual difficulty awakening, suspected seizure, loss of consciousness); BG measurement ≤49 mg/dL, or not measured but clinical manifestations reversed by oral carbohydrates, SC glucagon, or IV glucose. Crude event rate: total events divided by subject months multiplied by 100 ([total events/subject months]*100). Subjects months: elapsed number of months subject was in study in each time interval.|Month 1 through extension Month 36|FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.||event rate (events/subject months*100)|||Number
708492|NCT00136916|Secondary|Hypoglycemic Event Rates|Hypoglycemic event rate; hypoglycemic event identified by characteristic symptoms of hypoglycemia with no blood glucose (BG) check with prompt resolution with food intake, SC glucagon, or intravenous (IV) glucose; characteristic symptoms with BG of 59 mg/dL (3.2 mmol/L) or less with or without symptoms. Crude event rate = total events divided by subject months (elapsed number of months a subject was in the study at each time interval).|Month 1 through extension Month 36|FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.||event rate (events/subject months)|||Number
708493|NCT00136916|Primary|Summary of ≥ 20 % Decliners in DLco|Number of subjects with a post-baseline DLco decrease of ≥ 20 % [(baseline observed value - visit observed value)/(baseline observed value) * 100]; in the absence of an obvious intercurrrent illness, a repeat DLco was performed.|Month 3 through extension follow up Month 3|FAS FEV1; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.||participants|||Number
708494|NCT00136916|Primary|Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)|Change from baseline: mean of (value of observed DLco [milliliters per minute per millimeters of mercury (ml/min/mmHg)] at treatment observation minus baseline value).|Baseline through extension follow up Month 3|FAS FEV1; extension M36 LOCF based on data in the extension phase only; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively. Cross reference outcome measure Annual rate of change in Carbon Monoxide Diffusion Capacity (DLco).||ml/min/mmHg||Standard Deviation|Mean
708495|NCT00136916|Secondary|Lipid Panel: Total Cholesterol, High Density Lipoprotein, Low Density Lipoprotein, and Triglycerides|Lipid values for total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), and triglycerides measured as milligrams per deciliter (mg/dL).|Week -4 through Month 24|FAS: received at least 1 dose of study treatment. Due to early termination of study a limited set of analyses were undertaken and results of Lipids were not summarized as planned.||mg/dL||Standard Deviation|Mean
708496|NCT00136916|Secondary|Total Daily Short-acting Insulin Dose (Adjusted for Body Weight)|Total daily dose of short-acting insulin adjusted for body weight. Short-acting insulin (mg) for the inhaled insulin treatment group was inhaled insulin (mg divided by kg); short-acting insulin (units) for the subcutaneous insulin treatment group included insulin lispro, insulin aspart, and regular insulin (units divided by kg).|Month 3 through extension Month 36|FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.||mg/kg, units/kg||Standard Deviation|Mean
708499|NCT00136916|Secondary|Total Daily Long-acting Insulin Dose (Unadjusted for Body Weight)|Total daily long-acting insulin dose unadjusted for body weight. Long-acting (units) insulin for inhaled insulin and subcutaneous treatment groups included NPH insulin, Ultralente®, and insulin glargine.|Month 3 through extension Month 36|FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.||units||Standard Deviation|Mean
708500|NCT00136916|Secondary|Change From Baseline in Body Weight|Change from baseline: mean of (value of observed body weight [kilograms (kg)] at treatment observation minus baseline value).|Baseline through extension follow up Month 3|FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.||kg||Standard Deviation|Mean
708501|NCT00136916|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|Change from baseline: mean of (value of observed FPG [milligrams per deciliter (mg/dL)] at treatment observation minus baseline value).|Baseline through extension follow up Month 3|FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.||mg/dL||Standard Deviation|Mean
708502|NCT00136916|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|Change from baseline: mean of (value of observed HbA1c [%] at treatment observation minus baseline value).|Baseline through extension follow up Month 3|FAS HbA1c: received at least 1 dose of study treatment, had baseline HbA1c and at least 1 post-baseline HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.||percent||Standard Deviation|Mean
708503|NCT00136916|Secondary|Total Lung Capacity (TLC)|Total Lung Capacity measured in liters (L).|Baseline through extension follow up Month 3|FAS FEV1. Due to early termination of study a limited set of analyses were undertaken and results of TLC were not summarized as planned.||L||Standard Deviation|Mean
708504|NCT00136916|Secondary|Forced Vital Capacity (FVC)|Forced Vital Capacity (FVC) measured in liters (L).|Week -3 through extension follow up Month 3 or end of study|FAS FEV1. Due to early termination of study a limited set of analyses were undertaken and results of FVC were not summarized as planned.||L||Standard Deviation|Mean
708505|NCT00136916|Primary|Annual Rate of Change in Carbon Monoxide Diffusion Capacity (DLco)|Annual rate of change in DLco calculated as slope over time (visit) measured as milliliters per minute per millimeters of mercury per year (ml/min/mmHg/yr).|Week -2 through extension follow up Month 3 or end of study|FAS FEV1. Due to early termination of study a limited set of analyses were undertaken and results of Annual rate of change in DLco were not summarized as planned. Cross reference outcome measure: change from baseline in Carbon Monoxide Diffusion Capacity (DLco).||ml/min/mmHg/yr||Standard Deviation|Mean
708506|NCT00136916|Primary|Summary of ≥ 15 % Decliners in FEV1|Number of subjects with a post-baseline FEV1 decrease of ≥ 15 % [(baseline observed value - visit observed value)/(baseline observed value) * 100]; in the absence of an obvious intercurrrent illness, a repeat FEV1 was performed.|Month 3 through extension follow up Month 3|FAS FEV1; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.||participants|||Number
708507|NCT00136916|Primary|Annual Rate of Change in FEV1|Annual rate of change in FEV1 calculated as slope over time [visit] for forced expiratory volume in 1 second measured as liters per year (L/yr).|Week -2 through extension follow up Month 3 or end of study|FAS FEV1. Due to early termination of study a limited set of analyses were undertaken and results of Annual rate of change in FEV1 were not summarized as planned.||L/yr||Standard Deviation|Mean
708508|NCT00136916|Primary|Change From Baseline in FEV1|Change from baseline: mean of (value of observed FEV1 [L] at treatment observation minus baseline value).|Baseline through extension follow up Month 3|FAS FEV1; extension Month 36 (M36) Last Observation Carried Forward (LOCF) based on data in the extension phase only; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively. Cross reference outcome measure: change from Month 3 in forced expiratory volume in 1 second.||L||Standard Deviation|Mean
708509|NCT00136916|Primary|Change From Month 3 in Forced Expiratory Volume in 1 Second (FEV1)|Change from Month 3: mean of (value of observed FEV1 [forced expiratory volume in the first second of forced exhalation] in liters [L] at treatment observation minus Month 3 value).|Month 3 through extension Month 60|Full analysis set (FAS) FEV1: received at least 1 dose treatment, had baseline and at least 1 post-baseline FEV1. Due to study termination, originally planned inferential analysis for change from Month 3 through extension Month 60 was not done. Cross reference outcome measure: change from baseline in FEV1.||L||Standard Deviation|Mean
708510|NCT00136955|Secondary|Overall Survival (OS) and Time to Tumor Progression (ITT Population)|TTP is date of first infusion to first date of documented progression or date of death due to progressive disease or date of further anti-tumor therapy, whichever occurs first. OS is time from date of first infusion to date of death due to any cause or last date patient is known to be alive at date of data cutoff for final analysis.|Tumor response measurements were made at baseline, according to RECIST criteria. After end of treatment, subject was followed-up every 12 weeks plus or minus 2 weeks.|Intent-to-treat (ITT) population: All included subjects who received at least one drop of study medication will be included in the ITT population.||days||95% Confidence Interval|Median
708511|NCT00136955|Primary|Response to Treatment Based on RECIST Criteria (Intent-to-Treat [ITT] Population)|Tumor response according to RECIST.|At baseline and every 8 weeks through end of treatment (21-28 days after last administration of study treatment)|Intent-to-treat (ITT) population: All included subjects who received at least one drop of study medication will be included in the ITT population.||participant|||Number
708512|NCT00136955|Secondary|Overall Survival (OS) and Time to Tumor Progression (TTP) (Evaluable Population)|TTP is date of first infusion to first date of documented progression or date of death due to progressive disease or date of further anti-tumor therapy, whichever occurs first. OS is time from date of first infusion to date of death due to any cause or last date patient is known to be alive at date of data cutoff for final analysis.|Tumor response measurements were made at baseline, according to RECIST criteria. After end of treatment, subject was followed-up every 12 weeks plus or minus 2 weeks.|Evaluable population: 1) Patient received at least two complete cycles of treatment (8 weeks on study). If progression occurred before end of second cycle, patient considered evaluable (early progression); 2) all baseline lesions assessed at least once after second cycle with same method of measurement as baseline; 3) no major protocol violation.||days||95% Confidence Interval|Median
739882|NCT00459810|Secondary|Time to Disease Progression|Time from Day 1 to Day of meeting criteria for PSA or Measurable Disease Progression|At time of progression by PSA or RECIST criteria|||Days||95% Confidence Interval|Median
708513|NCT00136955|Primary|Response to Treatment Based on Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (Evaluable Population)|Tumor response according to RECIST.|At baseline and every 8 weeks through end of treatment (21-28 days after last administration of study treatment)|Evaluable population: 1) Patient received at least two complete cycles of treatment (8 weeks on study). If progression occurred before end of second cycle, patient considered evaluable (early progression); 2) all baseline lesions assessed at least once after second cycle with same method of measurement as baseline; 3) no major protocol violation.||participant|||Number
708514|NCT00137046|Secondary|Insulin Antibodies|Median insulin antibodies at each visit measured in micro units per milliliter (microU/mL).|Baseline through Extension Month 39|FAS; (n)= number of subjects with analyzable data at observation: inhaled insulin/SC insulin, respectively. Insulin antibody levels increased in Exubera®-treated compared to control subjects; results are included to establish there were no safety consequences due to these elevations although this was not an originally specified protocol endpoint.||microU/mL||Full Range|Median
708515|NCT00137046|Primary|Annual Rate of Change in Carbon Monoxide Diffusion Capacity (DLco)|Annual rate of change in DLco calculated as slope over time (visit) measured as milliliters per minute per millimeters of hemoglobin per year (ml/min/mmHg/yr).|Week -2 through Extension Follow-up Month 6 or end of study|FAS FEV1. Due to early termination of the study a limited set of analyses were undertaken and results of the annual rate of change in DLco were not summarized as planned.||ml/min/mmHg/yr||Standard Deviation|Mean
708516|NCT00137046|Primary|Annual Rate of Change in Forced Expiratory Volume in 1 Second (FEV1)|Annual rate of change in FEV1 calculated as slope over time [visit] for forced expiratory volume in 1 second measured as liters per year (L/yr).|Week -2 through Extension Follow-up Month 6 or end of study|FAS FEV1. Due to early termination of the study a limited set of analyses were undertaken and results of the Annual Rate of Change in FEV1 were not summarized as planned.||liters per year||Standard Deviation|Mean
708517|NCT00137046|Secondary|Total Lung Capacity (TLC)|Total Lung Capacity measured in liters (L).|Week -3 through Extension Follow-up Month 6 or End of Study|FAS FEV1. Due to early termination of the study a limited set of analyses were undertaken and TLC results were not summarized as planned.||liters||Standard Deviation|Mean
708518|NCT00137046|Secondary|Forced Vital Capacity (FVC)|Forced Vital Capacity (FVC) measured in liters (L).|Week -3 through Extension Follow-up Month 6 or End of Study|FAS FEV1. Due to early termination of the study a limited set of analyses were undertaken and FVC results were not summarized as planned.||liters||Standard Deviation|Mean
708519|NCT00137046|Primary|Summary of ≥ 20% Decliners in Carbon Monoxide Diffusing Capacity (DLco).|Number of subjects with a post-baseline Carbon Monoxide Diffusing Capacity (DLco) decrease of ≥ 20% [(baseline observed value minus visit observed value)/(baseline observed value) * 100]; in the absence of an obvious intercurrent illness, a repeat DLco was performed.|Month 3 through Extension Follow-up Month 3|FAS FEV1; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.||participants|||Number
708520|NCT00137046|Primary|Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)|Change from Baseline: mean of (value of Carbon Monoxide Diffusing Capacity [DLco] measured in milliters/minutes/millimeters of mercury [mL/min/mmHg] at observation minus Baseline value).|Baseline through Extension Follow-up Month 3|FAS FEV1; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively. Due to study termination, originally planned inferential analysis change from Month 3 to extension Month 60 was not done.||mL/min/mmHg||Standard Deviation|Mean
708521|NCT00137046|Secondary|Cough Questionnaire|Subject completed cough questionnaire with reference to the past 4 weeks. Six question instrument to measure cough frequency (night, day), severity, timing in relation to short-acting insulin dosing, severity related to insulin dosing (subcutaneous [SC] or inhaled), and productivity of cough; range 0 (no symptoms) to 4 (severe symptoms). Questionnaire was administered at Week 0 and then at subsequent visits only if cough was identified as an adverse event not explained by a concomitant condition, such as an upper respiratory tract infection.|Week 0 and if indicated through Extension Follow up Month 3|FAS. Due to early termination of the study a limited set of analyses were undertaken and results of the Cough Questionnaire were not summarized as planned.||scores on scale||Standard Deviation|Mean
708522|NCT00137046|Secondary|Lipids|Total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides measured as milligrams per deciliter (mg/dL).|Week -4 through Month 24|Full Analysis Set (FAS): received at least 1 dose of study treatment. Due to early termination of the study a limited set of analyses were undertaken and lipid results were not summarized as planned.||mg/dL||Standard Deviation|Mean
708523|NCT00137046|Secondary|Transition Dyspnea Index (TDI)|Clinician administered instrument to measure the baseline severity of breathlessness (shortness of breath) in symptomatic patients with 3 domains: functional impairment, magnitude of task, and magnitude of effort. TDI score range -3 (major deterioration) to +3 (major improvement); sum of all domains yields the TDI focal score (-9 to +9); lower score indicates greater deterioration. Compared to previous scoring to determine deterioration or improvement.|Week 4 through ,Extension Follow-up Month 6 and every 6 months thereafter or end of study|FAS FEV1. Due to early termination of the study a limited set of analyses were undertaken and results of the Transition Dyspnea Index were not summarized as planned.||scores on scale||Standard Deviation|Mean
708524|NCT00137046|Secondary|Baseline Dyspnea Index (BDI)|Clinician administered instrument to measure the baseline severity of breathlessness (shortness of breath) in symptomatic patients with 3 domains: functional impairment, magnitude of task, and magnitude of effort. BDI score range 0 (very severe impairment) to 4 (no impairment) scaled to a BDI focal score (0-12). Lower score indicates greater impairment.|Week - 1|FAS FEV1. Due to early termination of the study a limited set of analyses were undertaken and results of the Baseline Dyspnea Index were not summarized as planned.||scores on scale||Standard Deviation|Mean
708525|NCT00137046|Secondary|Total Daily Short-Acting Insulin Dose Adjusted for Body Weight|Total Daily Short-Acting Insulin Dose adjusted for body weight (milligrams [mg] or units divided by kilograms [kg]). Short-acting insulin (mg) for the Inhaled Insulin group was Inhaled Insulin. Short-acting insulin (unit) for the Subcutaneous Insulin group included Insulin Lispro, Insulin Aspart, and Regular Insulin.|Month 3 through Extension Month 39|FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.||mg/kg, units/kg||Standard Deviation|Mean
708526|NCT00137046|Secondary|Total Daily Short-Acting Insulin Dose (Unadjusted for Body Weight)|Total daily dose of short-acting insulin unadjusted for body weight. Short-acting insulin (mg) for the Inhaled Insulin group was Inhaled Insulin. Short-acting insulin (unit) for the Subcutaneous Insulin group included Insulin Lispro, Insulin Aspart, and Regular Insulin.|Month 3 through Extension Month 39|FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.||mg, units||Standard Deviation|Mean
708527|NCT00137046|Secondary|Total Daily Long-Acting Insulin Dose Adjusted for Body Weight|Total daily dose of long-acting insulin adjusted for body weight (units per kilogram [kg]). Long-acting insulin included NPH Insulin, Ultralente, and Insulin Glargine for both groups.|Month 3 through Extension Month 39|FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.||units/kg||Standard Deviation|Mean
708528|NCT00137046|Secondary|Total Daily Long-Acting Insulin Dose (Unadjusted for Body Weight)|Total Daily Long-Acting Insulin Dose Unadjusted for Body Weight; long-acting insulin included NPH Insulin, Ultralente, and Insulin Glargine for both groups.|Month 3 through Extension Month 39|FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.||units||Standard Deviation|Mean
708529|NCT00137046|Secondary|Change From Baseline Body Weight|Body weight: mean Baseline and change from Baseline in kilograms (kg). Change from baseline = mean body weight in kilograms (kg) at observation minus mean baseline body weight.|Baseline through Extension Follow-up Month 3|FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.||kilograms||Standard Deviation|Mean
708530|NCT00137046|Secondary|Change From Baseline in Fasting Plasma Glucose|Change from Baseline: mean of (value of fasting plasma glucose [milligrams per deciliter (mg/dL)] at observation minus Baseline value).|Baseline through Extension Follow-up Month 3|FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.||mg/dL||Standard Deviation|Mean
708531|NCT00137046|Secondary|Severe Hypoglycemic Event Rates|Severe hypoglycemic event = all 3 of the following criteria were met: subject unable to treat self, exhbited at least 1 neurological symptom (memory loss, confusion, uncontrollable behavior, irrational behavior, unusual difficulty in awakening, suspected seizure, loss of consciousness); and blood glucose measurement was ≤49 mg/dL, or not measured but clinical manifestations reversed by oral carbohydrates, subcutaneous glucagon, or i.v. glucose. Subject months = elapsed number of months subject was in study in each time interval. Crude event rate = total events divided by subject months * 100.|Month 1 through Extension Month 39|FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.||events / subject months * 100|||Number
708532|NCT00137046|Secondary|Hypoglycemic Event Rates|A Hypoglycemic event was identified by characteristic symptoms of hypoglycemia with no blood glucose check with prompt resolution with food intake, subcutaneous glucagon, or intravenouus glucose; characteristic symptoms with blood glucose of 59 milligrams per deciliter (mg/dL) (3.2 mmol/L) or less with blood glucose check; or any glucose measurement of 49 mg/dL (2.7 mmol/L) or less, with or without symptoms. Subject months = elapsed number of months a subject was in the study in each time interval. Crude event rate = total events divided by subject month of treatment.|Month 1 through Extension Month 39|FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.||total events/subject months|||Number
708533|NCT00137046|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|Change from Baseline: mean of (value of Glycosylated Hemoglobin [HbA1c] at observation minus Baseline value).|Baseline through Extension Follow-up Month 3|FAS HbA1c: received at least 1 dose of study treatment, had baseline HbA1c and at least 1 post-baseline HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.||percent||Standard Deviation|Mean
708534|NCT00137046|Primary|Summary of ≥ 15% Decliners in Forced Expiratory Volume in One Second (FEV1)|Number of subjects with a post-baseline Forced Expiratory Volume in One Second (FEV1) decrease of ≥ 15 % [(baseline observed value minus visit observed value)/(baseline observed value) * 100]; in the absence of an obvious intercurrent illness, a repeat FEV1 was performed.|Month 3 through Extension Follow-up 3|FAS FEV1; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.||participants|||Number
708535|NCT00137046|Primary|Change From Baseline in Forced Expiratory Volume in One Second (FEV1)|Change from Baseline: mean of (value of observed forced expiratory volume in the first second of forced exhalation [FEV1] in liters [L] at observation minus Baseline value).|Baseline through Extension Follow-up Month 3|Full Analysis Set (FAS) FEV1: received at least 1 dose of study drug, had a Baseline FEV1, and at least 1 post-baseline FEV1. Due to study termination, originally planned inferential analysis for change from Month 3 through extension Month 60 was not done. Cross reference outcome measure: change from baseline in FEV1.||liters||Standard Deviation|Mean
708536|NCT00137111|Other Pre-specified|Median Difference in NLRP3 Gene Expression in Primary Leukemia Cells of Patients in Glucocorticoid-resistant Cells vs. Glucocorticoid-sensitive Cells|Prednisolone sensitivity was measured in primary leukemia cells from bone marrow collected at diagnosis. Expression of NLRP3 was determined by HG-U133A microarray. Values given are gene expression values, and the unit is arbitrary units (AU) defined as scaled fluorescence measured on microarray.|Pre-treatment|One hundred forty-four (144) patients were evaluable to assess prednisolone sensitivity measured in bone marrow ALL cells and NLRP3 expression in RNA by MTT assay||arbitrary units||Inter-Quartile Range|Median
708537|NCT00137111|Other Pre-specified|Median Difference in CASP1 Gene Expression in Primary Leukemia Cells of Patients in Glucocorticoid-resistant Cells vs Glucocorticoid-sensitive Cells|Prednisolone sensitivity was measured in primary leukemia cells from bone marrow collected at diagnosis. Expression of CASP1 was determined by HG-U133A microarray. Values given are gene expression values, and the unit is arbitrary units (AU) defined as scaled fluorescence measured on microarray.|Pre-treatment|One hundred forty-four (144) patients were evaluable to assess prednisolone sensitivity measured in bone marrow ALL cells and CASP1 expression in RNA by MTT assay.||arbitrary units||Inter-Quartile Range|Median
708605|NCT00138151|Secondary|The Effect of the Regimen on Raf-1 Kinase Phosphorylation in Biopsy Specimens.||8 years|Study was closed prematurely due to slow accrual and lack of study drug. Insufficient accrual to evaluate response rate.|||||
708759|NCT00144170|Secondary|Virologic Response at Week 4|Virologic response defined as Viral Load<50 copies/mL|Week 4|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
708538|NCT00137111|Secondary|Circulating Leukemia Cells in Peripheral Blood Change From Prior to the Methotrexate Infusion to Three Days After Between Two Arms (4 Hours vs. 24 Hours)|"White blood cell (leukocytes) counts in peripheral blood by Complete Blood Count
Measurement: Percentage change of leukemia cells from baseline"|Immediately before the methotrexate infusion and three days after subsequent infusion|Three hundred twenty (320) patients were evaluable to assess the influence of infusion duration on methotrexate’s antileukemic effects.||Percent change||Standard Deviation|Mean
708539|NCT00137111|Secondary|Mean Difference of Active Methotrexate Polyglutamates (MTXPG) in Leukemia Cells Between Two Arms (4 Hours vs. 24 Hours).|Children were randomly assigned to receive initial single-agent treatment with HDMTX (1g/m^2) as either a 24-hour infusion or a 4-hour infusion and the outcome measure was the accumulation of MTXPG in leukemia cells.|42 hours after start of high dose methotrexate infusion (HDMTX)|The 286 patients randomized to treatment with high-dose methotrexate (HDMTX) who had methotrexate polyglutamate (MTXPG) concentration measured in bone marrow ALL cells .||pmol/1,000,000,000 cells||Standard Deviation|Mean
708540|NCT00137111|Secondary|Minimal Residual Disease (MRD)|Detection of MRD at end of induction where positive MRD was defined as one or more leukemic cell per 10,000 mononuclear bone-marrow cells (>=0.01%).|End of Induction (Day 46 MRD measurement)|Patients who completed induction and had successful MRD studies on day 46.||participants|||Number
708541|NCT00137111|Primary|Continuous Complete Remission Since Week 56 Therapy.|CCR was measured from end of week 56 therapy to the date of first treatment failure of any kind (relapse, death, lineage switch, or second malignancy) or to the last date of follow-up. Measurement was determined by Kaplan-Meyer estimate.|Median follow up time (range) 4.5 (1 to 7.8) years|Patients meeting the following high risk CNS Relapse criteria: white cell blood cell count at diagnosis more than 100,000; Philadelphia Chromosome Positive; CNS 3 at diagnosis; T-Lineage with white blood cell count more than 50,000.||Percentage of participants|||Number
708542|NCT00137111|Primary|Overall Event-free Survival (EFS)|EFS was measured from the start of on-study to the date of first treatment failure of any kind (relapse, death, lineage switch, or second malignancy) or to the last date of follow-up. Failure to enter remission was considered an event at time zero. Measurement was determined by Kaplan-Meyer estimate.|Median follow-up time (range) 5.6 (1.3 to 8.9) years|498 enrolled patients were eligible for analysis to estimate the overall event-free survival of children at least one year of age at diagnosis who are treated with risk-directed therapy.||Percentage of Participants|||Number
708543|NCT00137267|Secondary|Number of Days Engaged|Number of days veteran was involved with the program, from initial consent to last day of contact|8 weeks|||Days engaged in program||Standard Deviation|Mean
708544|NCT00137267|Primary|Treatment Engagement|Number of inpatient and outpatient treatment sessions attended during the 8-week treatment period|8 weeks|||number of treatment sessions attended||Standard Deviation|Mean
708545|NCT00137280|Primary|The Effect of Care Model Implementation on Treatment Appropriateness: Patient Employment Outcomes|Chi-square analysis was used to examine competitive employment gained during treatment in implementation versus control groups. The dependent variable was competitive employment. Individuals included were only those who expressed interest in returning to work at both the baseline and follow-up interview time-points.|1 year|||competitive employment|||Number
708546|NCT00137280|Primary|The Effect of Care Model Implementation on Treatment Appropriateness: Supported Employment Utilization|The number of participants with one or more Supported Employment appointments in the one year during implementation (implementation sites versus control sites) for those participants who endorsed a desire to return to work at the baseline interview (e.g., eligible for Supported Employment services). This only includes participants who endorsed a desire to return to work at the baseline interview (e.g., eligible for Supported Employment services).|1 year|||participants|||Number
708547|NCT00137280|Primary|The Effect of Care Model Implementation on Treatment Appropriateness: Patient Weight Outcomes|Analysis of Covariance (ANCOVA) was used to examine weight gained during treatment in implementation versus control groups. The dependent variable was final weight. Baseline weight, weight 6 months prior to baseline, and baseline psychotic and negative symptom subscales were included as covariates. The inclusion of weight 6 months prior to baseline served to control for subjects’ weight gain/loss trajectories prior to entering the study. The two-way interactions of group by covariates were also included in the model.|1 year|||pounds||Standard Error|Least Squares Mean
708548|NCT00137280|Primary|The Effect of Care Model Implementation on Treatment Appropriateness: Weight Service Utilization|The number of participants with one or more weight service appointments in the one year during implementation (implementation sites versus control sites) for those participants who were overweight at the baseline interview (e.g., eligible for weight services). This only includes participants who were overweight at the baseline interview (e.g., eligible for weight services).|1 year|||participants|||Number
708549|NCT00137423|Secondary|Change From Baseline in EuroQoL Visual Analog Scale (EQ-VAS) Overall Health Thermometer Score|EQ-VAS score on the self-rated “thermometer” indicated the patient’s own assessment of their health status from 0 (worst) to 100 (best) imaginable health state. Change: median score at observation minus median score at baseline. Maximum changes (increase or decrease from baseline).|Day 1 and day 15 of each treatment cycle from cycle 1 to cycle 4; day 1 of each treatment cycle after cycle 4 up to one year.|ITT||score on scale||Full Range|Median
708550|NCT00137423|Secondary|Change From Baseline in Euro-QoL Five Dimension (EQ-5D) Weighted Health Index|EQ-5D health status in 5 dimensions (mobility, self-care, pain / discomfort, anxiety / depression, usual activities) with a weighted health index based on general population values where 0.0=death and 1.0 = perfect health. Change: median index score at observation minus median index score at baseline.|Day 1 and day 15 of each treatment cycle from cycle 1 to cycle 4; day 1 of each treatment cycle after cycle 4 up to one year.|ITT||score on scale||Full Range|Median
708568|NCT00137436|Secondary|Duration of PSA Response (DPR)|Defined as time from first documentation of PSA response (≥50% decrease in PSA from baseline that is subsequently confirmed) to first documentation of PSA progression (defined for patients with a PSA response as a 50% increase over nadir [lowest] and increase in absolute-value PSA level by at least 5 ng/mL [or back to baseline] and for patients without a PSA response as a 25% increase over baseline [or nadir / lowest] and increase in absolute-value PSA level by at least 5 ng/mL, both confirmed by a second value). Calculated as (end date for DPR – first PSA response + 1)/7.|Baseline to first documentation of PSA progression up to 28 days after date of last dose|ITT; DPR only calculated for the subgroup of patients with PSA response rate.||weeks||Full Range|Median
708551|NCT00137423|Secondary|Summary of FACIT Fatigue Scale Overall Score|FACIT Fatigue Scale: Overall score from 13-questionnaire, which measures fatigue / asthenia for patients with chronic, life-threatening illnesses. For each question, a patient rates his / her condition for the past week on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). Higher scores always represent less fatigue / asthenia. Outcome based on completed questionnaires.|Day 1 and day 15 of each treatment cycle from cycle 1 to cycle 4; day 1 of each treatment cycle after cycle 4 up to one year.|ITT; Results summarized by cohort & time point through Cycle 13 (the last cycle for which more than 3 subjects completed the questionnaire on either arm). If more than 50% of the items in the scale were answered, then missing items were imputed with the mean of the non-missing items scored at that visit. Outcome based on completed questionnaires.||score on scale||Standard Deviation|Mean
708552|NCT00137423|Secondary|Overall Survival|Overall survival is time from the date of first dose of medication to the date of death due to any cause|4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up|ITT; Patients who are alive at the time of analysis or who are lost to follow up are censored on the last date they were known to be alive. Estimates are based on the Kaplan-Meier method with 95% CI calculated based on Brookmeyer and Crowley method. n=54,53(AM,PM).||weeks||95% Confidence Interval|Median
708553|NCT00137423|Secondary|Progression Free Survival (PFS)|Using RECIST criteria: Time from date 1st dose study medication to date 1st documentation of objective tumor progression or death due to any cause occurring on treatment including within 28 days after last dose, whichever occurred 1st. Censored on day following the date of last oncologic assessment documenting absence of tumor progression. PFS based on the number of subjects with measurable disease at baseline, the correct histological cancer type, and had disease that was refractory to prior cytokine-based therapy(105 in total group).|4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up|ITT; Calculation based on subgroup of patients with baseline disease assessment, measurable disease at baseline, correct histological type and are refractory to cytokine. Estimates based on Kaplan-Meier method with 95% CI calculated based on Brookmeyer and Crowley. N=53,52(AM,PM).||weeks||95% Confidence Interval|Median
708554|NCT00137423|Secondary|Time to Tumor Progression (TTP)|Time from date of first dose of study medication to date of first documentation of objective tumor progression using RECIST criteria that occurred on treatment including within 28 days after the last dose of study medication. TTP censored on the day following the date of last oncologic assessment documenting absence of tumor progression. TTP based on the number of subjects with measurable disease at baseline, the correct histological cancer type, and had disease that was refractory to prior cytokine-based therapy(105 in total group).|4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up|ITT;TTP calculated based on subgroup with baseline disease assessment, measurable disease at baseline, correct histological type and refractory to cytokine.Estimates based on Kaplan-Meier method with 95% CI calculated based on Brookmeyer and Crowley. n=53,52(AM,PM).||weeks||95% Confidence Interval|Median
708555|NCT00137423|Secondary|Duration of Tumor Response|Using RECIST criteria: date of 1st objective tumor response (CR or PR) subsequently confirmed to date of 1st objective tumor progression or to death due to any cause within 28 days after last dose of study medication, whichever was first. Censored on day after the date of the last oncologic assessment documenting no tumor progression.|4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up|ITT; DR time from start of 1st documentation of objective tumor response to 1st documentation of objective tumor progression or death & calculated for the subgroup of subjects with a confirmed objective tumor response. Descriptive statistics for responders who had an event. Total number responders n= 15,6(AM,PM). Response duration n=7,3(AM,PM).||weeks||Full Range|Median
708556|NCT00137423|Primary|Objective Response (Complete Response[CR] + Partial Response[PR]) in Subjects|Confirmed objective responses using RECIST criteria defined as responses persisting on repeat imaging study for 2 assessments with at least 4 weeks between, and evaluating all target and non-target sites followed since baseline. Two PRs separated by an SD or NE visit in between was considered a confirmed response if the 2 PRs were > 4 weeks apart. CR=disappearance of all target lesions. PR is a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up|ITT; CR,PR calculated from patients with measurable disease at baseline+correct histological cancer type+ refractory to prior cytokine-based therapy n= 53,52 (AM,PM)||participants|||Number
708557|NCT00137436|Secondary|Preliminary Assessment of PSA Modulation by SU011248|PSA modulation analyzed by the mean change in PSA response measured as ng/mL.|Baseline to Day 28|ITT population; PSA modulation was listed as a secondary endpoint for Phase 2, however, modulation was planned for analysis only for Phase 1 portion of the study. No formal analysis was completed to determine modulation.||ng/mL||95% Confidence Interval|Mean
708558|NCT00137436|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire (FACT-General and Prostate Cancer Subscale)|Assesses health related quality of life and advanced prostate cancer specific symptoms. FACT-General (FACT-G) assesses 4 domains: physical, social and family, emotional, and functional well-being. The prostate cancer subscale assesses prostate cancer symptoms focusing on pain, urination problems, and sexual functions. Individual scores range from 0 (not at all) to 4 (very much). Scores for some of the individual questions are reverse-coded in order for higher scores to correspond to better health status. FACT-P overall score range is 0 to 156; higher scores indicate better health status.|Baseline (C1.D1), Day 1 of Cycles 2 through 16, and End of Treatment (EOT=following Cycle 16 or within 7 days of withdrawal from study)|PRO evaluable population; (n)=number of participants with evaluable data at observation.||scores on a scale||95% Confidence Interval|Mean
708569|NCT00137436|Secondary|Time to PSA Progression|Defined as the time from start of study treatment to first documentation of PSA progression using the PSA Working Group criteria calculated as (first event date – first dose date + 1)/7. PSA progression is defined for patients with a PSA response, as a 50% increase over nadir (lowest) and increase in absolute-value PSA level by at least 5 nanograms per milliliter (ng/mL) [or back to baseline] and for patients without a PSA response as a 25% increase over baseline [or nadir (lowest)] and increase in absolute-value PSA level by at least 5 ng/mL, both confirmed by a second value.|Baseline to first documentation of PSA progression up to 28 days after date of last dose|ITT||weeks||Full Range|Median
708559|NCT00137436|Secondary|Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Interference (Questions 7A Through 7G)|The questionnaire assesses pain intensity (worst, least, average, and right now), level of relief in the last 24 hours, and the impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). The pain interference index score (to measure how much pain had interfered with daily activities) was derived from Questions 7A-7G with a range from 0 (no interference) to 10 (completely interferes); higher scores indicate more interference.|Baseline (C1.D1), Day 1 of Cycles 2 through 16, and End of Treatment (EOT=following Cycle 16 or within 7 days of withdrawal from study)|PRO evaluable population; (n)=number of participants with evaluable data at observation.||scores on a scale||95% Confidence Interval|Mean
708560|NCT00137436|Secondary|Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) : Pain Intensity (Questions 2-5)|The questionnaire assesses pain intensity (worst, least, average, and right now), level of relief in the last 24 hours, and the impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). The pain intensity index score was derived from Questions 2-5 with range from 0 to 10 (0: no pain; 1-4: mild pain; 5-6: moderate pain; 7-10: severe pain); higher scores indicate worse health status.|Baseline (C1.D1), Day 1 of Cycles 2 through 16, and End of Treatment (EOT=following Cycle 16 or within 7 days of withdrawal from study)|Patient reported outcomes (PRO) evaluable population defined as participants in the ITT population who received at least 1 dose of study medication (sunitinib or docetaxel) and had baseline data; (n)=number of participants with evaluable data at observation.||scores on a scale||95% Confidence Interval|Mean
708561|NCT00137436|Secondary|Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFR3|Soluble protein biomarker VEGFR3 measured as pg/mL. CBR defined as confirmed CR (disappearance of all target lesions) or confirmed PR (≥30% decrease in sum of longest dimensions [LD] of target lesions taking as reference the baseline sum LD) or SD (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease) ≥3 months versus PD (≥20% increase in sum LD of target lesions taking as reference the smallest sum LD recorded since treatment started, unequivocal progression of existing non-target lesions, or appearance of ≥1 new lesions) or SD <3 months.|Baseline (C1.D1), C1.D14, C2.D1, C2.D14, C3.D14|ITT||pg/mL||Full Range|Median
708562|NCT00137436|Secondary|Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFR2|Soluble protein biomarker VEGFR2 measured as pg/mL. CBR defined as confirmed CR (disappearance of all target lesions) or confirmed PR (≥30% decrease in sum of longest dimensions [LD] of target lesions taking as reference the baseline sum LD) or SD (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease) ≥3 months versus PD (≥20% increase in sum LD of target lesions taking as reference the smallest sum LD recorded since treatment started, unequivocal progression of existing non-target lesions, or appearance of ≥1 new lesions) or SD <3 months.|Baseline (C1.D1), C1.D14, C2.D1, C2.D14, C3.D14|ITT||pg/mL||Full Range|Median
708563|NCT00137436|Secondary|Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFC|Soluble protein biomarker VEGFC measured as pg/mL. CBR defined as confirmed CR (disappearance of all target lesions) or confirmed PR (≥30% decrease in sum of longest dimensions [LD] of target lesions taking as reference the baseline sum LD) or SD (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease) ≥3 months versus PD (≥20% increase in sum LD of target lesions taking as reference the smallest sum LD recorded since treatment started, unequivocal progression of existing non-target lesions, or appearance of ≥1 new lesions) or SD <3 months.|Baseline (C1.D1), C1.D14, C2.D1, C2.D14, C3.D14|ITT||pg/mL||Full Range|Median
708564|NCT00137436|Secondary|Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFR3|Soluble protein biomarker Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) measured as picograms per milliliter (pg/mL). PSA responders are participants with a confirmed PSA response as per the Working Group criteria (>50% decrease from baseline) and non-responders are those not meeting the definition of responder. Ratio=value of soluble protein biomarkers at each time point to the value at baseline (C1D14 : C1D1).|Baseline (C1.D1), C1.D14, C2.D1, C2.D14, C3.D1, C3.D14|ITT||pg/mL||Full Range|Median
708565|NCT00137436|Secondary|Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFR2|Soluble protein biomarker Vascular Endothelial Growth Factor receptor 2 (VEGFR2) measured as pg/mL. PSA responders are participants with a confirmed PSA response as per the Working Group criteria (>50% decrease from baseline) and non-responders are those not meeting the definition of responder. Ratio=value of soluble protein biomarkers at each time point to the value at baseline (C1D14 : C1D1).|Baseline (C1.D1), C1.D14, C2.D1, C2.D14, C3.D1, C3.D14|ITT||pg/mL||Full Range|Median
708566|NCT00137436|Secondary|Ratio to Baseline (Bsl) in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFC|Soluble protein biomarker Vascular Endothelial Growth Factor C (VEGFC) measured as picograms per milliliter (pg/mL). PSA responders are participants with a confirmed PSA response as per the Working Group criteria (>50% decrease from baseline) and non-responders are those not meeting the definition of responder. Ratio=value of soluble protein biomarkers at each time point to the value at baseline (C1D14 : C1D1).|Baseline (Cycle 1 Day 1 [C1.D1]), C1.D14, C2.D1, C2.D14, C3.D1, C3.D14|ITT||pg/mL||Full Range|Median
708567|NCT00137436|Secondary|Percentage of Participants With Objective Response Rate (ORR)|Defined as confirmed complete response (CR: disappearance of all target lesions) or confirmed partial response (PR: ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD) according to response evaluation criteria in solid tumors (RECIST). Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.|Baseline to first documentation of PSA progression up to 28 days after date of last dose|ITT; N=participants with measurable disease at baseline, received at least 1 dose of study medication, and had correct histological cancer type.||percentage of participants||95% Confidence Interval|Number
708570|NCT00137436|Primary|Percentage of Participants With Prostate Specific Antigen (PSA) Response|PSA response rate, which is defined as a greater than or equal to a 50% decrease in PSA from baseline, that is subsequently confirmed.|Baseline, Day 1 of each 21-day cycle|The intent-to-treat (ITT) population was defined as all patients enrolled in the study that receive at least 1 dose of study medication (SU011248 or docetaxel)||percentage of participants||95% Confidence Interval|Median
708571|NCT00137449|Secondary|Score of EQ-5D (Euro Quality of Life-5 Dimension) Weighted Health Index|EQ-5D: health status in 5 dimensions (mobility, self-care, pain/discomfort, anxiety/depression, usual activities) with a weighted health Index based on general population values where 0.0 = death and 1.0 = perfect health. Change: median index score at observation minus median index score at baseline (includes data available for >=10 subjects).|Baseline, Day 1 & 15 of each treatment cycle up to 1 year on study|ITT population||score on scale||Full Range|Median
708572|NCT00137449|Secondary|Score of EQ-VAS (Euro Quality of Life -Visual Analog Scale)|EQ-VAS score on the self-rated “thermometer,” indicating the patient's own assessment of their health status from 0 (worst) to 100 (best) imaginable health state. Change: median score at observation minus median score at baseline. Maximum changes (Increase or Decrease from baseline) included data available for >=10 subjects.|Baseline, Day 1 &15 of each treatment cycle up to 1 year on study|ITT population.||score on scale||Full Range|Median
708573|NCT00137449|Secondary|Score of FACIT-Fatigue Scale|FACIT-Fatigue Scale: Overall score from 13-question questionnaire (measures fatigue/asthenia for patients with chronic, life-threatening illnesses). For each question, patient rates condition for the past week on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). Maximum, minimum mean included data available for >=10 subjects.|Baseline, Day 1 & 15 of each treatment cycle|ITT population||score on scale||Standard Deviation|Mean
708574|NCT00137449|Secondary|Overall Survival (OS) and One-year Survival [Descriptive Statistics]|Overall survival is defined as time from the date of first dose of study medication to the date of death due to any cause. One year survival rate defined as the probability that a patient is alive 1 year after the date of first study medication.|Survival status was collected by telephone contact every 2 months for up to 2 years from study entry.|ITT population (all subjects enrolled that received at least 1 dose of study medication).||participants|||Number
708575|NCT00137449|Secondary|Duration of Tumor Response (DR) [Descriptive Statistics]|DR was defined as the time from the date of first documentation of objective tumor response (CR or PR) that was subsequently confirmed to the date of the first documentation of objective tumor progression or to death due to any cause that occurred within 28 days after the last dose of study medication, whichever occurred first.|Planned duration on this protocol of up to 1 year|ITT population (all subjects enrolled that received at least 1 dose of study medication) with measurable disease at baseline and correct histological cancer type. Number of responders (AM=3, PM=5, Total=8)||weeks||Full Range|Median
708576|NCT00137449|Secondary|Time to Tumor Progression (TTP)|TTP was defined as the time from the date of first dose of study medication to the date of first documentation of objective tumor progression that occurred on treatment including within 28 days after the last dose of study medication.|Planned duration on this protocol of up to 1 year|ITT population (all subjects enrolled that received at least 1 dose of study medication) with measurable disease at baseline and correct histological cancer type.||participants|||Number
708577|NCT00137449|Secondary|Progression-free Survival (PFS)|PFS was defined as the time from the date of first dose of study medication to the date of first documentation of objective tumor progression or to death due to any cause that occurred on treatment including within 28 days after the last dose of study medication, whichever occurred first.|Planned duration on this protocol of up to 1 year|ITT population (all subjects enrolled that received at least 1 dose of study medication) with measurable disease at baseline and correct histological cancer type.||participants|||Number
708578|NCT00137449|Secondary|Duration of Stable Disease|Duration of SD is the time from the date of first documentation of stable disease to the date of first documentation of objective tumor progression or death due to any cause that occurred within 28 days after last dose of study medication, whichever occurred first.|Planned duration on this protocol of up to 1 year|ITT population (all subjects enrolled that received at least 1 dose of study medication) with measurable disease at baseline and correct histological cancer type.||Participants|||Number
708579|NCT00137449|Secondary|Number of Participants With Overall Confirmed Objective Disease Response (ORR)|Overall confirmed objective disease response is defined as a confirmed CR, or confirmed PR according to RECIST. Confirmed responses are those that persisted on repeat imaging >= 4 wks after initial response.|Planned duration on this protocol of up to 1 year|ITT population (all subjects enrolled that received at least 1 dose of study medication) with measurable disease at baseline and correct histological cancer type.||participants|||Number
708580|NCT00137449|Secondary|Number of Participants by Best Confirmed Response Category According to RECIST|Best confirmed response (BCR) defined as best response [confirmed CR, confirmed PR, SD, PD(progressive disease), not evaluable (NE)] recorded from start of treatment until disease progression / recurrence. Best response of SD must have met SD criteria at least once after first dose at minimum interval of 6 weeks.|Planned duration on this protocol of up to 1 year|ITT population (all subjects enrolled that received at least 1 dose of study medication) with measurable disease at baseline and correct histological cancer type.||participants|||Number
708581|NCT00137449|Primary|Number of Participants With Clinical Benefit Response (CBR) According to RECIST|CBR is defined as a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) for at least 24 weeks on study according to RECIST. Confirmed responses are those that persisted on repeat imaging >= 4 wks after initial response. Participants with no on-study radiographic tumor re-evaluation counted as non-responders.|Planned duration on this protocol of up to 1 year|ITT population (all subjects enrolled that received at least 1 dose of study medication) with measurable disease at baseline and correct histological cancer type. CR+PR+(SD for >=24 weeks)||participants|||Number
708582|NCT00137631|Primary|Number of Episodes of Receptive Unprotected Anal Intercourse (UAI) With Casual Partners||6 months|||number of episodes||Standard Deviation|Mean
708583|NCT00137631|Primary|Number of Episodes of Insertive Unprotected Anal Intercourse (UAI) With Casual Partners||6 months|||number of episodes||Standard Deviation|Mean
708584|NCT00137631|Primary|Number of Participants Reporting Sexually Transmitted Disease (STD) Testing Behavior||6 months|||participants|||Number
708585|NCT00137631|Primary|Number of Participants Reporting HIV Testing Behavior||6 months|||participants|||Number
708586|NCT00137631|Primary|Any Unprotected Anal Intercourse (UAI) With Casual Partners|Sexual activities with casual male partners in past 3 months (i.e., any unprotected insertive or receptive anal sex)|6 months|||Number of episodes||Standard Deviation|Mean
708598|NCT00138073|Primary|Score on a Computer-based Test on Pulmonary Artery Catheter Waveform Interpretation|The study was terminated before the primary outcome could be measured. None of the participants took the post-intervention test.|1 month||||||
708587|NCT00137969|Secondary|Number of Participants Who Achieved an MCR in The ITT Population|The BILAG Index measures clinical disease activity in SLE. A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains. MCR = participants who achieved BILAG C scores or better at 24 weeks, maintained this response without developing a flare to 52 weeks, and did not experience a severe flare from Day 1 to Week 24.|From Weeks 24 to 52|ITT population||participants|||Number
708588|NCT00137969|Secondary|Change in SLE Expanded Health Survey Physical Function Score From Baseline|Short Form (36) with additional questions specific to lupus (scale = 0-100; with 100 representing the highest level of functioning possible) to measure the ability of rituximab to improve quality of life. A positive value for this outcome measure indicates that symptoms have improved.|From baseline to 52 weeks|ITT population||score on a scale||Standard Deviation|Mean
708589|NCT00137969|Secondary|Time to First Moderate or Severe Flare|The BILAG Index measures clinical disease activity in SLE. A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains. A severe flare = participants had BILAG A score(s) present in one or more domains or BILAG B scores present in three or more domains at the same visit following a visit of inactive disease state defined above. A moderate flare = participants had only BILAG B scores present in two domains at the same visit following a visit of inactive disease state.|52 weeks|Number of participants who ever reached C/D/E for all 8 BILAG domains before Day 364 visit. If a participant reached C/D/E at the last visit, then this participant was excluded from the analysis.||days||95% Confidence Interval|Median
708590|NCT00137969|Secondary|Number of Participants Who Achieved a BILAG C or Better in All Domains|The BILAG Index measures clinical disease activity in SLE. A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains.|24 weeks|ITT population||participants|||Number
708591|NCT00137969|Secondary|Number of Participants Who Achieved a PCR (Including MCR)|The BILAG Index measures clinical disease activity in SLE. A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains. PCR = participants who achieved BILAG C score or better at 24 wks and maintained response without a flare for 16 consecutive weeks, or maximum of one BILAG B score at 24 weeks and maintained response without a flare to 52 wks, or maximum of 2 BILAG B scores at 24 wks without development of BILAG scores of A or B until Week 52 if the baseline BILAG score was 1A+>=2Bs, or>=2 As, or>=4 Bs, or participants who enrolled with scores of severe disease and did not achieve a single BILAG B at Month 6. MCR = participants who achieved BILAG C or better at 24 weeks, maintained this response without developing a flare to 52 weeks, and did not experience a severe flare from Day 1 to Week 24.|From baseline to 52 Weeks|ITT population||participants|||Number
708592|NCT00137969|Secondary|Number of Participants Who Achieved an MCR (Excluding PCR)|The BILAG Index measures clinical disease activity in SLE. A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains. MCR = participants who achieved BILAG C scores or better at 24 weeks, maintained this response without developing a flare to 52 weeks, and did not experience a severe flare from Day 1 to Week 24. PCR = participants who achieved BILAG C score or better at 24 wks and maintained response without a flare for 16 consecutive weeks, or maximum of one BILAG B score at 24 weeks and maintained response without a flare to 52 wks, or maximum of 2 BILAG B scores at 24 wks without development of BILAG scores of A or B until Week 52 if the baseline BILAG score was 1A+>=2Bs, or>=2 As, or>=4 Bs, or participants who enrolled with scores of severe disease and did not achieve a single BILAG B at Month 6.|From baseline to 52 weeks|ITT population||participants|||Number
708593|NCT00137969|Secondary|Time-adjusted Area Under The Curve Minus Baseline (AUCMB) of BILAG Score Over The 52-week Treatment Period|"The BILAG Index measures clinical disease activity in SLE. A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains. The AUCMB of BILAG Score Over 52 Weeks was calculated as:
Calculate the AUC of the BILAG global score versus time (in days) by 52 weeks.
Calculate the Time-Adjusted AUC by dividing the AUC by the number of days a patient was on the study.
Minus the Time-Adjusted AUC by the baseline BILAG global score"|From baseline to 52 weeks|ITT population||BILAG score unit||Standard Deviation|Mean
708594|NCT00137969|Primary|Number of Participants Who Achieved a Major Clinical Response (MCR), Partial Clinical Response (PCR), or Nonclinical Response (NCR) Defined by British Isles Lupus Assessment Group (BILAG) Scores Over The 52-week Treatment Period|The BILAG Index measures clinical disease activity in Systemic Lupus Erythematosus (SLE). A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains. MCR = participants who achieved BILAG C scores or better at 24 weeks, maintained this response without developing a flare to 52 weeks, and did not experience a severe flare from Day 1 to Week 24; PCR = participants who achieved BILAG C score or better at 24 wks and maintained response without a flare for 16 consecutive weeks, or maximum of one BILAG B score at 24 weeks and maintained response without a flare to 52 wks, or maximum of 2 BILAG B scores at 24 wks without development of BILAG scores of A or B until Week 52 if the baseline BILAG score was 1A+>=2Bs, or>=2 As, or>=4 Bs, or participants who enrolled with scores of severe disease and did not achieve a single BILAG B at Month 6.|From baseline to 52 weeks|Intent-to-treat (ITT) population||Participants|||Number
708595|NCT00138034|Secondary|Composite of Death, Reinfarction, Stroke and Revascularization at the Time of Follow-up Angiography|The occurence of any one of the above mentioned outcome measures. Only the first event per patient is counted.|6 months|||participants|||Number
708596|NCT00138034|Primary|6-month Reocclusion|Less than TIMI (Thrombolysis In Myocardial Infarction) -3 flow of the infarct related coronary artery assessed at follow-up angiography|6 months|||participants|||Number
708597|NCT00138073|Secondary|Individual and Collective Frequency of Use and Usage Patterns of the Web-based Waveform Interpretation Guide|The study was terminated before the secondary outcome could be measured. Usage data was not collected over the following year.|1 year||||||
708599|NCT00138125|Secondary|Clinical Benefit (CR + PR + SD > 6 Months)||5 years||||||
708600|NCT00138125|Secondary|Overall Survival||5 years||||||
708610|NCT00138203|Secondary|Time to Progression|Time to progression per Response Evaluation Criteria In Solid Tumors and assessed by CT: Complete Response(CR), Disappearance of all target lesions; Partial Response(PR),>=30% decrease in the sum of the longest diameter of target lesions; Overall Response(OR) = CR + PR.|From start of treatment to progression (average was 3.7 months)|Subjects who were considered evaluable (received more than one treatment cycle) were included in these results.||months||Full Range|Median
708611|NCT00138203|Primary|Response Per RECIST Criteria|Per Response Evaluation Criteria In Solid Tumors and assessed by CT: Complete Response(CR), Disappearance of all target lesions; Partial Response(PR),>=30% decrease in the sum of the longest diameter of target lesions; Overall Response(OR) = CR + PR.|Time from treatment initiation until the end of treatment. The median number of cycles was 3 (range 1-27)|Only 14 subjects were evaulated for response. 2 of the total 16 subjects enrolled were not evaluable due to progression after only 1 cycle of treatment.||participants|||Number
708612|NCT00138294|Secondary|Proportion of SAEs Detected in LAIV Recipients|Serious adverse events (SAEs) within 42 days post-LAIV vaccination will be captured in seasonal and pandemic vaccinated study subjects.|pre-, post- influenza vaccination|This analyses was limited to the children enrolled in the intervention cities. 29255 doses of LAIV were administered to children 4-18 years of age. 21555 doses were seasonal LAIV and 7700 doses were pandemic LAIV.||proportion of events|||Number
708613|NCT00138294|Primary|MAARI Rate During the Epidemic and Pandemic Period (2009-2010)|The rate of MAARI (MAARIs/1000 persons-week) were compared between the intervention and comparison cities during the epidemic period (irrespective of the vaccination status). This data was obtained from the SWHP database.|8/25/09 to 4/3/10 (32 weeks)|Overall rate of MAARI (MAARIs/1000 persons-week) were compared between the intervention and comparison cities during the epidemic period (irrespective of the vaccination status). Total number of participants reflect the number of SWHP participants in the intervention and comparison cities respectively.||Number of MAARI|Person Weeks||Number
708614|NCT00138294|Primary|MAARI Rate During the Epidemic Period (2008-2009)|The rate of MAARI (MAARIs/1000 persons-week) were compared between the intervention and comparison cities during the epidemic period (irrespective of the vaccination status). This data was obtained from the SWHP database.|1/4/2009 to 3/21/2009 (11 weeks)|Overall rate of MAARI (MAARIs/1000 persons-week) were compared between the intervention and comparison cities during the epidemic period (irrespective of the vaccination status). Total number of participants reflect the number of SWHP participants in the intervention and comparison cities respectively.||Number of MAARI|Person Weeks||Number
708615|NCT00138294|Primary|MAARI Rate During the Epidemic Period (2007-2008)|The rate of MAARI (MAARIs/1000 persons-week) were compared between the intervention and comparison cities during the epidemic period (irrespective of the vaccination status). This data was obtained from the SWHP database.|12/16/2007 to 3/29/2008 (15 weeks)|Overall rate of MAARI (MAARIs/1000 persons-week) were compared between the intervention and comparison cities during the epidemic period (irrespective of the vaccination status). Total number of participants reflect the number of SWHP participants in the intervention and comparison cities respectively.||Number of MAARI|Person Weeks||Number
708632|NCT00138645|Primary|Percent Change in Body Weight (Completers).|Percent change in body weight from baseline to week 24(completers).|24 weeks|||change in percent:baseline body weight||Standard Error|Least Squares Mean
708633|NCT00138645|Secondary|Subjective Ratings of Appetite at Week 2 and Months 1, 2, 3, 4, 5, and 6||April 2005 to May 2006||||||
708634|NCT00138645|Secondary|Disease Biomarkers (Cholesterol, Triglycerides, Etc.) at Months 3 and 6||April 2005 to May 2006||||||
708635|NCT00138645|Secondary|Change in Body Composition at Months 3 and 6||April 2005 to May 2006||||||
708636|NCT00138645|Primary|Body Weight Loss (kg and Percent) at Months 3 and 6||April 2005 to May 2006||||||
708637|NCT00138658|Secondary|AUC-0-last|AUC-0-last is the area under the plasma concentration time curve from time 0 to the last last time point (23.5 hrs)|Blood samples were collected as follows. Cycle 1; Day 1: pre-dose, 2 h (EOI), 0.5 h, 1 hr, 1.5 h, 2.5 h, 4 h, 6.5 h and 23.5 h post end of OGX-011 infusion, Day 22: pre-dose Cycle 2.|Data are reported for the 6 subjects who received 640 mg OGX-011. This is the dose to be used in additional Phase 3 studies of OGX-011||ng*h/mL||Standard Deviation|Mean
708638|NCT00138658|Secondary|t1/2 of OGX-011|Plasma half life of OGX-011|Blood samples were collected as follows. Cycle 1; Day 1: pre-dose, 2 h (EOI), 0.5 h, 1 hr, 1.5 h, 2.5 h, 4 h, 6.5 h and 23.5 h post end of OGX-011 infusion, Day 22: pre-dose Cycle 2.|Data are reported for the 6 subjects who received 640 mg OGX-011. This is the dose to be used in additional Phase 3 studies of OGX-011||hours||Standard Deviation|Mean
708639|NCT00138658|Primary|Objective Response Rate of OGX-011 in Combination With Gemcitabine/Platinum-based Regimen|"Per RECIST Criteria V 1.0 and based on radiographic evaluations a subject was defined as having an objective response (OR) if the subject achieved either a confirmed partial response (PR) or confirmed complete response (CR).
The evaluations were conducted after every two cycles of treatment for a maximum of 6 cycles.
CR: disappearance of clinical/radiological evidence of tumor.
PR: >= 30% decrease in the sum of the longest diameter of target lesions.
SD: did not fulfill the criteria for CR or PR but not progressive disease."|Based on assessments at baseline and after Cycles 2, 4, and 6. All subjects were followed for survival for a minimum of 3 years after the first dose of OGX-011 or until death.|The efficacy analysis included all 81 subjects that received at least one dose of OGX-011. Of the 25 subjects with CR or PR, 21 subjects had a confirmed response. The other 4 patients did not have confirmatory scans (n=3) or discontinued treatment (N=1).||percentage of participants|||Number
708640|NCT00138658|Secondary|Cmax of OGX-011|Cmax is a plasma pharmacokinetic parameter that is defined as the maximum observed concentration of drug substance in plasma.|Blood samples were collected as follows. Cycle 1; Day 1: pre-dose, 2 h (EOI), 0.5 h, 1 hr, 1.5 h, 2.5 h, 4 h, 6.5 h and 23.5 h post end of OGX-011 infusion, Day 22: pre-dose Cycle 2.|Data are reported for the 6 subjects who received 640 mg OGX-011. This is the dose to be used in additional Phase 3 studies of OGX-011||ng/mL||Standard Deviation|Mean
708641|NCT00138658|Secondary|Effect of OGX-011 on Serum Clusterin Levels|To measure the effect of OGX-011 on serum clusterin levels. The drug substance, OGX-011, is an antisense product designed to bind to clusterin mRNA, resulting in the inhibition of the production of human clusterin protein. Therefore, serum clusterin levels were expected to decrease.|Blood samples were collected at baseline and prior to infusion on Cycle 2 Day 1 and Cycle 3 Day 1|55 evaluable subjects had baseline value and at least one post-baseline serum clusterin assessment.||µg/mL||Standard Deviation|Mean
708760|NCT00144170|Secondary|Virologic Response at Week 2|Virologic response defined as Viral Load<50 copies/mL|Week 2|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
708642|NCT00138658|Secondary|Overall Survival|Overall survival was defined as time from date of first treatment with OGX-011 to the date of death from any cause. Overall survival was censored at date of last contact for subjects who were still alive at end of study.|All subjects were followed for a minimum of 3 years after the first dose of OGX-011 or until death.|Number of subjects who died (n=70); n=11 subjects were censored at end of study (10 were alive and 1 was lost to follow up)||months||95% Confidence Interval|Median
708643|NCT00138658|Secondary|Progression-free Survival|Progression-free survival (PFS) was defined as time from first treatment with OGX-011 to documented evidence of disease progression or date of death. For subjects without disease progression based on RECIST who initiated subsequent anti-cancer therapy, date of progression was defined as date of initiating new cancer treatment. PFS was censored as of the date of first OGX-011 dose for subjects who failed to return for assessments after screening. For subjects who were still alive and without progressive disease at the time of data cut-off, PFS was censored at date of last disease assessment.|All subjects were followed for a minimum of 3 years after the first dose of OGX-011 or until death.|Number of patients who progressed or died (n=75); data for 6 patients were censored. (PFS was censored at the date of the first dose of OGX-011 for subjects who failed to return for any disease assessments after screening.)||months||95% Confidence Interval|Median
708644|NCT00138671|Secondary|Severe Hypoglcyemic Event Rates|An event was severe if the subject was unable to treat him/herself; had at least 1 neurological symptom; or blood glucose of < = 49 mg/dL or the blood glucose was not measured, but the clinical manifestations were reversed by oral carbohydrates, subcutaneous glucagon, or intravenous glucose. Crude event rate=total events/100 subject-months. Subject-months=elapsed number of months a subject was in the study in each time interval.|0 to 1 month to > 11 months|FAS, HbA1c=all randomized subjects who received at least 1 dose of study treatment, had a baseline HbA1c measurement, and had at least 1 HbA1c post-baseline measurement. Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.||events / 100 subject-months|||Number
708645|NCT00138671|Secondary|Hypoglycemic Event Rates|A hypoglycemic event was identified by characteristic symptoms; blood glucose levels at 59 mg/dL (3.2 mmol/L) or less with a glucose check; or any glucose measurement 49 mg/dL (2.7 mmol/L) or less, with or without symptoms. Crude event rate=total events divided by subject-months. Subject-months=elapsed number of months a subject was in the study in each time interval.|0 to1 month to > 11 months|FAS, HbA1c=all randomized subjects who received at least 1 dose of study treatment, had a baseline HbA1c measurement, and had at least 1 HbA1c post-baseline measurement. Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.||events / subject-month|||Number
708646|NCT00138671|Secondary|Lipids|Lipids collected: Total cholesterol, high-density lipoprotein, low-density lipoptrotein, and triglycerides. Lipids data were collected, but not analyzed.|Duration of the study|||mg/dL|||Number
708647|NCT00138671|Secondary|Mean Total Daily Short-Acting Insulin Dose (Adjusted for Body Weight)|Short-acting insulin (mg) for the Inhaled Insulin group was Inhaled Insulin. Short-acting insulin (unit) for the Subcutaneous Insulin group included Insulin Lispro, Insulin Aspart, and Regular Insulin. Dose was adjusted for body weight (mg divided by kg or units divided by kg).|Weeks 1, 2, 3, 4, 6, 9, 12, 18, 26, 39, 52|FAS, HbA1c=all randomized subjects who received at least 1 dose of study treatment, had a baseline HbA1c measurement, and had at least 1 HbA1c post-baseline measurement. Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.||mg/kg, Units/kg||Standard Deviation|Mean
708648|NCT00138671|Secondary|Mean Total Daily Intermediate-/Long-Acting Insulin Dose (Adjusted for Body Weight)|Intermediate/long-acting insulin included Insulin NPH, Ultralente, and Insulin Glargine for both groups. Dose was adjusted for body weight (units divided by kg).|Weeks 1, 2, 3, 4, 6, 9, 12, 18, 26, 39, 52|FAS, HbA1c=all randomized subjects who received at least 1 dose of study treatment, had a baseline HbA1c measurement, and had at least 1 HbA1c post-baseline measurement. Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.||Units/kg||Standard Deviation|Mean
708649|NCT00138671|Secondary|Mean Total Daily Short-Acting Insulin Dose (Unadjusted for Body Weight)|Short-acting insulin (mg) for the Inhaled Insulin group was Inhaled Insulin. Short-acting insulin (unit) for the Subcutaneous Insulin group included Insulin Lispro, Insulin Aspart, and Regular Insulin.|Weeks 1, 2, 3, 4, 6, 9, 12, 18, 26, 39, 52|FAS, HbA1c=all randomized subjects who received at least 1 dose of study treatment, had a baseline HbA1c measurement, and had at least 1 HbA1c post-baseline measurement. Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.||mg, Units||Standard Deviation|Mean
708650|NCT00138671|Secondary|Mean Total Daily Intermediate-/Long-Acting Insulin Dose (Unadjusted for Body Weight)|Intermediate-/long-acting insulin included Insulin NPH, Ultralente, and Insulin Glargine for both groups.|Weeks 1, 2, 3, 4, 6, 9, 12, 18, 26, 39, 52|FAS, HbA1c=all randomized subjects who received at least 1 dose of study treatment, had a baseline HbA1c measurement, and had at least 1 HbA1c post-baseline measurement. Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.||Units||Standard Deviation|Mean
708651|NCT00138671|Secondary|Change From Baseline in Body Weight|Change from baseline: mean of (value of observed body weight in kilograms (kg) at treatment duration minus baseline value).|Baseline, Weeks 1, 2, 3, 4, 6, 9, 11, 12, 18, 26, 39, 50, 51, 52|FAS, HbA1c=randomized subjects with >=1 study drug dose, baseline and >=1 post-baseline HbA1c measurement. Last Observation Carried Forward (LOCF) method used. Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin. Week 11 and 50 visits were part of the methacholine substudy and were not required visits for all subjects.||kg||Standard Deviation|Mean
708652|NCT00138671|Secondary|Change From Baseline in Fasting Plasma Glucose|Change from baseline: mean of (value of observed fasting plasma glucose in milligrams/deciliters (mg/dL) at treatment duration minus baseline value).|Baseline, Weeks 6, 12, 26, 39, 52|FAS, HbA1c=all randomized subjects who received at least 1 dose of study treatment, had a baseline HbA1c measurement, and had at least 1 HbA1c post-baseline measurement. Week 52 Last Observation Carried Forward (LOCF)=subjects' last measurement carried forward. Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.||mg/dL||Standard Deviation|Mean
708653|NCT00138671|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|Change from baseline: mean of (value of observed HbA1c at treatment duration minus baseline value).|Baseline, Weeks 6, 12, 26, 39, and 52|FAS, HbA1c=all randomized subjects who received at least 1 dose of study treatment, had a baseline HbA1c measurement, and had at least 1 HbA1c post-baseline measurement. Week 52 Last Observation Carried Forward (LOCF)=subjects' last measurement carried forward. Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.||percent||Standard Deviation|Mean
708655|NCT00138671|Secondary|Incidence of Severe COPD Exacerbations|Severe COPD exacerbation = a COPD-related hospitalization > 24 hours. Crude event rate = total events divided by subject-months. Subject-months=elapsed number of months a subject was in the study in each time interval.|0 to 1 week to > 9 months|FAS, FEV1=all randomized subjects who received at least 1 dose of study treatment, had a baseline FEV1 measurement (post-bronchodilator), and had at least 1 FEV1 post-baseline measurement (post-bronchodilator). Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.||events/subject-month (crude event rate)|||Number
708656|NCT00138671|Secondary|Incidence of Non-Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations|Non-severe COPD exacerbation = additional therapy (systemic corticosteroids, antibiotics, oxygen) needed for worsening respiratory symptoms and/or lung function, not needing hospitalization > 24 hours. Crude event rate = total events divided by subject-months. Subject-months=elapsed number of months a subject was in the study in each time interval.|0 to 1 week to > 9 months|FAS, FEV1=all randomized subjects who received at least 1 dose of study treatment, had a baseline FEV1 measurement (post-bronchodilator), and had at least 1 FEV1 post-baseline measurement (post-bronchodilator). Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.||events/subject-month (crude event rate)|||Number
708657|NCT00138671|Secondary|Mean Weekly Number of Puffs of Short-Acting Bronchodilator Used|All subjects used diary cards to record their daily use of short-acting bronchodilators. Subjects recorded the sum of their short-acting bronchodilator use (puffs of albuterol plus ipratropium plus Combivent®, as applicable) daily, immediately upon arising, and again in the evening or before bed. Mean weekly number of puffs of short-acting bronchodilator used data were collected, but not analyzed.|Duration of the study|||puffs|||Number
708658|NCT00138671|Secondary|Methacholine PC20|Methacholine challenge testing was conducted at selected sites at visits which did not occur at other sites (Weeks -2.9, -0.9, 11, 50 and 52+5). Methacholine challenge was not analyzed as there was only 1 test performed, which was a baseline test, and no methacholine tests performed in subjects using inhaled insulin.|Duration of the study|||mg/mL|||Number
708659|NCT00138671|Secondary|Insulin Dose Responsiveness for DLco|DLco dose responsivness 10 and 60 minutes after insulin. DLco dose-responsiveness to insulin (defined as the difference between the DLco value following a dose of insulin and DLco value before a dose of insulin, operationally defined as the post-dose DLco value minus pre-dose DLco value).|Baseline, Week 9, Week 51|FAS, FEV1=all randomized subjects who received at least 1 dose of study treatment, had a baseline FEV1 measurement (post-bronchodilator), and had a FEV1 post-baseline measurement (post-bronchodilator). Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.||mL/min/mmHg||Standard Deviation|Mean
708660|NCT00138671|Secondary|Insulin Dose Responsiveness for FEV1|FEV1 dose responsiveness 10 and 60 minutes after insulin. FEV1 dose-responsiveness to insulin (defined as the difference between the FEV1 value following a dose of insulin and FEV1 value before a dose of insulin, operationally defined as the post-dose FEV1 value minus pre-dose FEV1 value).|Baseline, Week 9, Week 51|FAS, FEV1=all randomized subjects who received at least 1 dose of study treatment, had a baseline FEV1 measurement (post-bronchodilator), and had at least 1 FEV1 post-baseline measurement (post-bronchodilator). Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.||L||Standard Deviation|Mean
708661|NCT00138671|Secondary|Bronchodilator Responsiveness as Determined by the Change in FEV1|Responsiveness was the percent change from the FEV1 value before bronchodilator use to the FEV1 value 30 minutes after bronchodilator use, operationally defined as [(post-bronchodilator FEV1 minus pre-bronchodilator FEV1 divided by pre-bronchodilator FEV1] multiplied by 100.|Weeks 1, 2, 3, 4, 6, 12, 18, 26, 39, 52|FAS, FEV1=all randomized subjects who received at least 1 dose of study treatment, had a baseline FEV1 measurement (post-bronchodilator), and had at least 1 FEV1 post-baseline measurement (post-bronchodilator). Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.||percent change||Standard Deviation|Mean
708662|NCT00138671|Secondary|Other PFTs (Besides FEV1 and DLco)|Other PFTs (besides FEV1 and DLco) were measured 30 minutes following the administration of ipratropium. Other PFTs included forced vital capacity (FVC), peak expiratory flow rate (maximal forced expiratory flow) (PEFR[FEFmax]), and forced expiratory flow from 25% to 75% of vital capacity (FEF25%-75%). Other PFT data were collected, but not analyzed.|Duration of the study|||mL|||Number
708663|NCT00138671|Primary|Change From Baseline in Post-Bronchodilator Carbon Monoxide Diffusion Capacity (DLco)|DLco measured in milliters/minutes/millimeters of mercury (mL/min/mmHg) 30 minutes following the administration of ipratropium. Change from baseline: mean of (value of observed DLco (mL/min/mmHg) at treatment duration minus baseline value).|Baseline, Weeks 1, 2, 3, 4, 6, 12, 18, 26, 39, 52|FAS, FEV1=all randomized subjects who received at least 1 dose of study treatment, had a baseline FEV1 measurement (post-bronchodilator), and had at least 1 FEV1 post-baseline measurement (post-bronchodilator). Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.||mL/min/mmHg||Standard Deviation|Mean
708664|NCT00138671|Secondary|Full PFTs (DLco, Pre-Ipratropium and Pre- Insulin PFTs)|Full PFTs included DLco pre- and 30-minutes post-ipratropium and were completed between the hours of 6 AM and 10 AM with subjects in the fasting state. Full PFT data were collected, but not analyzed.|Duration of the study|||mL/min/mmHg|||Number
708665|NCT00138671|Secondary|Full Pulmonary Function Tests (PFTs) (Spirometry, Pre-Ipratropium and Pre-Insulin PFTs)|Full PFTs included spirometry pre- and 30-minutes post-ipratropium and were completed between the hours of 6 AM and 10 AM with subjects in the fasting state. Full PFT data were collected, but not analyzed.|Duration of the study|||L|||Number
708666|NCT00138671|Primary|Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)|FEV1 was measured in liters (L) 30 minutes following the administration of ipratropium. Change from baseline: mean of (value of observed FEV1 (L) at treatment duration minus baseline value).|Baseline, Weeks 1, 2, 3, 4, 6, 12, 18, 26, 39, 52|Full Analysis Set (FAS), FEV1=all randomized subjects who received at least 1 dose of study treatment, had a baseline FEV1 measurement (post-bronchodilator), and had at least 1 FEV1 post-baseline measurement (post-bronchodilator). Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.||L||Standard Deviation|Mean
708761|NCT00144170|Secondary|Virologic Response|Virologic response defined as Viral Load<50 copies/mL|Week 2 through Week 96 (at any point during trial)|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
708667|NCT00130039|Secondary|Numbers of Fatal or Major Bleeding Complications|life-threatening or fatal bleeding was defined as any fatal bleeding event, a drop in hemoglobin of ≥ 50g/L, or significant hypotension with need for inotropic agents, symptomatic intracranial hemorrhage, or transfusion of ≥ 4 units of red-blood cells or equivalent amount of whole blood. Major bleeding was defined as significantly disabling bleedings, intraocular bleeding leading to significant visual loss, or bleeding requiring transfusion of ≤ 3 units of red-blood cells or equivalent amount of whole blood|upto 7 months after randomization|this outcome analysis was done ITT method||events|||Number
708668|NCT00130039|Secondary|Number of Patients With Ipsilateral Ischemic Stroke Rate|ischemic stroke event which occured in the vascular territory of initial symptomatic stenosis|upto 7 months after randomization|this outcome analysis was done ITT method||participants|||Number
708669|NCT00130039|Secondary|Number of Participants With Overall Cardiovascular Events|including nonfatal stroke, nonfatal myocardial infarction and vascular death.|upto 7 months after randomization|this outcome analysis was done intention to treat method||participants|||Number
708670|NCT00130039|Secondary|Number of Participants With Stroke Events|including nonfatal ischemic stroke, nonfatal hemorrhagic stroke and fatal stroke|upto 7 months after randomization|this outcome analysis performed on the intention to treat (ITT) method||participants|||Number
708671|NCT00130039|Secondary|Number of Participants With New MRI (Magnetic Resonance Image) Lesions on Follow-up MRI|number of patients with new ischemic lesions on FLAIR (Fluid attenuation inversion recovery) images of follow-up MRI, which were determined by slice to slice comparison with baseline MRI.|7 months after treatment|this analysis included the patients who had performed follow-up FLAIR imaging||pariticipants|||Number
708672|NCT00130039|Primary|Number of Participants With Progression of Symptomatic Intracranial Stenosis|"Blind reviewers classified the presence and severity of stenosis on middle cerebral arteries and basilar artery on magnetic resonance angiogram (MRA) into 5 grades; normal, mild, moderate, severe and occlusion. Progression was defined as worsening of stenosis by 1 or more grades on final MRA as compared with the baseline MRA.
The progression of symptomatic stenosis is defined as 1 or more grade worsening of the stenosis on the symptomatic artery on MRA."|7 months after treatment|||participants|||Number
708673|NCT00143247|Primary|Change in Carbon Monoxide Diffusing Capacity (mL/Min/mm Hg) by Time on Exubera Treatment|Change from Baseline: mean of (value of observed Carbon Monoxide Diffusing Capacity (mL/min/mm Hg) at treatment duration minus baseline value). Duration of treatment is based on the elapsed duration of treatment in the controlled and uncontrolled studies. Baseline was based on pre-inhaled insulin measurements.|baseline to 126 months|173 subjects received at least one treatment. The safety analysis set (subjects who received at least one dose of EXU treatment) were included in analysis. n = subjects who had outcome measure data available at particular time points. There was no imputation for missing data.||mL/min/mm Hg||Standard Deviation|Mean
708674|NCT00143247|Secondary|Number of Decliners in Carbon Monoxide Diffusing Capacity (ml/Min/mm Hg) by Duration of Exubera Treatment|Decliners at particular timepoint were defined as any decline of ≥20% in carbon monoxide diffusing capacity.|6 to >=108 months|173 subjects received at least one treatment. The safety analysis set (subjects who received at least one dose of EXU treatment) were included in analysis. n = subjects who had outcome measure data available at particular time points. There was no imputation for missing data.||participants|||Number
708675|NCT00143247|Secondary|Number of Decliners in Forced Expiratory Volume in 1 Second (L) by Duration of Exubera Treatment|Decliners at particular timepoint were defined as any decline of ≥15% in forced expiratory volume.|3 to >=108 months|173 subjects received at least one treatment. The safety analysis set (subjects who received at least one dose of EXU treatment) were included in analysis. n = subjects who had outcome measure data available at particular time points. There was no imputation for missing data.||participants|||Number
708676|NCT00143247|Secondary|Number of Decliners in Either Forced Expiratory Volume in 1 Second (L) or Carbon Monoxide Diffusing Capacity (ml/Min/mm Hg), by Duration of Exubera Treatment|Decliners = decline of ≥15% in forced expiratory volume or ≥20% in carbon monoxide diffusing capacity.|3 to >=108 months|173 subjects received at least one treatment. The safety analysis set (subjects who received at least one dose of EXU treatment) were included in analysis. n = subjects who had outcome measure data available at particular time points. There was no imputation for missing data.||participants|||Number
708677|NCT00143247|Secondary|Insulin Antibodies (Percent Binding) by Time on Exubera Treatment - Subjects With Type 2 Diabetes (Not Using Insulin at Study Entry)|Observed values by duration of treatment.|6 to 120 months|173 subjects received at least one treatment. The safety analysis set (subjects who received at least one dose of EXU treatment) were included in analysis. n = subjects who had outcome measure data available at particular time points. There was no imputation for missing data.||percent binding||Full Range|Median
708678|NCT00143247|Primary|Change in Forced Expiratory Volume in 1 Second (L) by Time on Exubera Treatment|Change from Baseline: mean of (value of observed forced expiratory volume in 1 second (FEV1) (liters) at treatment duration minus baseline value). Duration of treatment is based on the elapsed duration of treatment in the controlled and uncontrolled studies. Baseline was based on pre-inhaled insulin measurements.|Baseline to 126 months|173 subjects received at least one treatment. The safety analysis set (subjects who received at least one dose of EXU treatment) were included in analysis. n = subjects who had outcome measure data available at particular time points. There was no imputation for missing data.||liters||Standard Deviation|Mean
708679|NCT00143247|Secondary|Insulin Antibodies (Percent Binding) by Time on Exubera Treatment – Subjects With Type 2 Diabetes (Using Insulin at Study Entry)|observed values by duration of treatment.|36 to 126 months|173 subjects received at least one treatment. The safety analysis set (subjects who received at least one dose of EXU treatment) were included in analysis. n = subjects who had outcome measure data available at particular time points. There was no imputation for missing data.||percent binding||Full Range|Median
708680|NCT00143247|Secondary|Insulin Antibodies (Percent Binding) by Time on Exubera Treatment - Subjects With Type 1 Diabetes|Observed values by duration of treatment.|36 months to 126 months|173 subjects received at least one treatment. The safety analysis set (subjects who received at least one dose of EXU treatment) were included in analysis. n = subjects who had outcome measure data available at particular time points. There was no imputation for missing data.||percent binding||Full Range|Median
714980|NCT00247273|Secondary|Percent Change From Baseline in Serum BAP at Month 24, ITT Population|Assayed by ELISA (enzyme-linked immunosorbent assay)|Baseline to Month 24|ITT||Percent Change||95% Confidence Interval|Least Squares Mean
708681|NCT00143247|Secondary|Severe Hypoglycemic Event Rates by Interval of Exubera Treatment|Number of severe hypoglycemic events per 100 subject-months.Subject-month determined by time on treatment.Interval of treatment based on elapsed duration of treatment in controlled & uncontrolled studies.Overall represents entire duration of treatment.A severe hypoglycemic event must have met all 3of following:1.subject unable to treat self.2.subject exhibited 1 or more of neurological symptoms defined in protocol.3.blood glucose must be <=49 mg/dl if measured.If not measured,clinical manifestations must have been reversed by oral carbohydrates,subcutaneous glucagon,or intravenous glucose.|0-132 months|173 subjects received at least one treatment. The safety analysis set (subjects who received at least one dose of EXU treatment) were included in analysis. n = subjects who had outcome measure data available at particular time points. There was no imputation for missing data.||severe events / 100 subject-months|||Number
708682|NCT00143247|Secondary|Hypoglycemic Event Rates by Interval of Exubera Treatment|Number of hypoglycemic events per subject-month. Subject-month determined by time on treatment. Interval of treatment based on elapsed duration of treatment in the controlled & uncontrolled studies.Overall represents entire duration of treatment. Hypoglycemia: Characteristic symptoms of hypoglycemia with no blood glucose check. Clinical picture must include prompt resolution with food intake, subcutaneous glucagon or intravenous glucose.OR,Characteristic symptoms of hypoglycemia with blood glucose check showing glucose <=59 mg/dl.OR,Any glucose measurement <=49 mg/dl,with or without symptoms.|0 to 132 months|173 subjects received at least one treatment. The safety analysis set (subjects who received at least one dose of EXU treatment) were included in analysis. n = subjects who had outcome measure data available at particular time points. There was no imputation for missing data.||events / subject-month|||Number
708683|NCT00143247|Secondary|Change in Glycosylated Hemoglobin by Duration of Exubera Treatment|Change from Baseline: mean of (value of observed glycosylated hemoglobin (HbA1C) (percent) at treatment duration minus baseline value). Duration of treatment is based on the elapsed duration of treatment in the controlled and uncontrolled studies. Baseline was based on pre-inhaled insulin measurements.|Baseline to 126 months|173 subjects received at least one treatment. The safety analysis set (subjects who received at least one dose of EXU treatment) were included in analysis. n = subjects who had outcome measure data available at particular time points. There was no imputation for missing data.||percent HbA1C||Standard Deviation|Mean
708684|NCT00143312|Secondary|Survival Without Proven or Probable Invasive Fungal Infection (IFI)|Number of participants who survive (ie., are alive) without proven or probable IFI at each of the 6 and 12 month follow-up visits|6 months, 12 months|Complete case analysis using MITT population (ie, all subjects who had at least 1 dose of study medication & at least 1 post-enrollment efficacy assessment & a previous diagnosis of proven or probable IFI, confirmed by Data Review Committee) & either provided an IFI assessment at follow-up visit, died or experienced an IFI before that visit.||participants|||Number
708685|NCT00143312|Secondary|Time to Occurrence of Proven or Probable Recurrent Invasive Fungal Infection (IFI) (Same Pathogen as Previous Baseline IFI)|Time to occurrence of proven or probable recurrent (same pathogen as baseline) IFI from the start of voriconazole prophylaxis. Time to occurrence is strictly time to recorded diagnosis of IFI. The pathogen identified as the positive culture recorded nearest to, but not after, the proven or probable IFI, was assumed to be responsible for the IFI.|12 months|Modified intent-to-treat (MITT) population (considered evaluable for efficacy) consisted of all subjects who had at least 1 dose of voriconazole & at least 1 post-enrollment efficacy assessment & had a previous diagnosis of proven or probable IFI, confirmed by the Data Review Committee. Two subjects experienced a recurrent proven or probable IFI.||days|||Number
708686|NCT00143312|Secondary|Time to Occurrence of Proven or Probable New (New Pathogen) Invasive Fungal Infection (IFI)|Time to occurrence of proven or probable new (new pathogen) IFI from the start of voriconazole prophylaxis. Time to occurrence is strictly time to recorded diagnosis of IFI.|12 months|Modified intent-to-treat (MITT) population (considered evaluable for efficacy) consisted of all subjects who had at least 1 dose of voriconazole & at least 1 post-enrollment efficacy assessment & had a previous diagnosis of proven or probable IFI, confirmed by the Data Review Committee. One subject in the MITT population experienced a new IFI.||days|||Number
708687|NCT00143312|Secondary|Time to Occurrence of Proven or Probable Invasive Fungal Infection (IFI)|Time to occurrence of proven or probable IFI from the start of voriconazole prophylaxis. Time to occurrence is strictly time to recorded diagnosis of IFI since the exact day on which the IFI began will not be known.|12 months|Modified intent-to-treat (MITT) population (considered evaluable for efficacy) consisted of all subjects who had at least 1 dose of voriconazole & at least 1 post-enrollment efficacy assessment & had a previous diagnosis of proven or probable IFI, confirmed by the Data Review Committee. Three subjects in the MITT population experienced an IFI.||days|||Number
708688|NCT00143312|Secondary|Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Voriconazole Prophylaxis Until End of Prophylaxis Visit|Number of participants developing a proven or probable IFI from start of voriconazole prophylaxis until the End of Prophylaxis visit|150 days|Complete case analysis (ie, outcome must be observed and/or subject must be evaluable for entire period of interest) using modified intent-to-treat (MITT) population (ie, subjects had at least 1 dose of voriconazole & at least 1 post-enrollment efficacy assessment & previous diagnosis of proven or probable IFI, confirmed by Data Review Committee).||participants|||Number
708689|NCT00143312|Secondary|Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Prophylaxis Until 6-month Follow-up Visit|Number of participants developing a proven or probable IFI from start of voriconazole prophylaxis until 6-month follow up|6 months|Complete case analysis (ie, outcome must be observed and/or subject must be evaluable for entire period of interest) using modified intent-to-treat (MITT) population (ie, subjects had at least 1 dose of voriconazole & at least 1 post-enrollment efficacy assessment & previous diagnosis of proven or probable IFI, confirmed by Data Review Committee).||participants|||Number
708690|NCT00143312|Primary|Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Prophylaxis Until 12-month Follow-up Visit|Number of participants developing a proven or probable IFI from start of voriconazole prophylaxis until 12-month follow up|12 months|Complete case analysis (ie, outcome must be observed and/or subject must be evaluable for entire period of interest) using modified intent-to-treat (MITT) population (ie, subjects had at least 1 dose of voriconazole & at least 1 post-enrollment efficacy assessment & previous diagnosis of proven or probable IFI, confirmed by Data Review Committee).||participants|||Number
708691|NCT00143390|Secondary|Time to Treatment Failure (TTF)|TTF is defined as the time from the randomization to the date of the first documentation of progressive disease (PD), symptomatic deterioration, death due to any cause, or treatment discontinuation due to adverse event, refusal or other reasons.|Up to 2008 days of the treatment|Full Analysis Set (FAS) was defined as subjects who were randomized, and administered study medication at least once, and who had at least one efficacy evaluation specified in the protocol.||months||95% Confidence Interval|Median
708692|NCT00143390|Secondary|Overall Survival (OS)|OS is defined as time from the date of randomization to the date of death.|Up to 2008 days of the treatment|Full Analysis Set (FAS) was defined as subjects who were randomized, and administered study medication at least once, and who had at least one efficacy evaluation specified in the protocol.||months||95% Confidence Interval|Median
708693|NCT00143390|Secondary|Number of Participants With Clinical Benefit - Investigator Assessment|Number of participants with clinical benefit based assessment of CR, PR or long-term stable disease (SD) according to the RECIST (version 1.0). CR and PR are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as the disappearance of all target and nontarget lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters (SLD) of the targeted lesions. Long-term SD was defined as SD lasted for at least 24 weeks (168 days). Clinical benefit = CR + PR + long SD|Up to 2008 days of the treatment|Full Analysis Set (FAS) was defined as participants who were randomized, and administered study medication at least once, and who had at least one efficacy evaluation specified in the protocol. Further more, participants with bone metastasis alone or not evaluable based on RECIST were excluded from this analysis.||participants|||Number
708694|NCT00143390|Secondary|Number of Participants With Objective Response - Investigators Assessment|Number of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST version 1.0). CR and PR are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as the disappearance of all target and nontarget lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters (SLD) of the targeted lesions. Objective Response (OR)= CR + PR.|Up to 2008 days of the treatment|Full Analysis Set (FAS) was defined as participants who were randomized, and administered study medication at least once, and who had at least one efficacy evaluation specified in the protocol. Further more, participants with bone metastasis alone or not evaluable based on RECIST were excluded from this analysis.||participants|||Number
708695|NCT00143390|Secondary|Time to Progression (TTP) - Investigators Assessment|Time in months from randomization to first documentation of objective tumor progression or death due to breast cancer, whichever comes first. Tumor progression was determined by the investigator using RECIST version 1.0 as an at least a 20% increase in the sum of the longest diameters (SLD) of the target lesions compared to the smallest SLD since the study treatment started. For participants with bone metastasis only, at least 25% increase in the measurable lesion according to General Rules for Clinical and Pathological Study of Breast Cancer (The 14th edition).|Up to 2008 days of the treatment|Full Analysis Set (FAS) was defined as participants who were randomized, and administered study medication at least once, and who had at least one efficacy evaluation specified in the protocol.||months||90% Confidence Interval|Median
708696|NCT00143390|Primary|Time to Progression (TTP) - Expert Evaluation Committee Assessment|Time in months from randomization to first documentation of objective tumor progression or death due to breast cancer, whichever comes first. Tumor progression was determined by the expert evaluation committee using RECIST version 1.0 as an at least a 20% increase in the sum of the longest diameters (SLD) of the target lesions compared to the smallest SLD since the study treatment started. For participants with bone metastasis only, at least 25% increase in the measurable lesion according to General Rules for Clinical and Pathological Study of Breast Cancer (The 14th edition).|Up to 2008 days of the treatment|Full Analysis Set (FAS) was defined as participants who were randomized, and administered study medication at least once, and who had at least one efficacy evaluation specified in the protocol.||months||95% Confidence Interval|Median
708697|NCT00143403|Secondary|Overall Survival Rates|Probability of being alive was calculated in a yearly increment.|Median follow-up time (42 months)|Full analysis set = all treated subjects according to randomization: n=153, 153 for 5-FU/FA & Irinotecan + 5-FU/FA, respectively. Safety analysis set (for Adverse Events) = all treated subjects according to treatment actually received (1 subject randomized to 5-FU/FA actually received treatment from Irinotecan + 5-FU/FA). n=152, 154 as above).||survival rate|||Number
708698|NCT00143403|Primary|Disease Free Survival (DFS)|time interval between the date of randomization and the earliest date of local, regional or distant relapse, or death due to cancer.|last tumor assessment date or cut-off date, whichever is earlier.|Full analysis set = all treated subjects according to randomization: n=153, 153 for 5-FU/FA & Irinotecan + 5-FU/FA, respectively. Safety analysis set (for Adverse Events) = all treated subjects according to treatment actually received (1 subject randomized to 5-FU/FA actually received treatment from Irinotecan + 5-FU/FA). n=152, 154 as above).||months||95% Confidence Interval|Median
708699|NCT00143455|Secondary|Tumor Related Symptoms (Pain, Dyspnea, Cough, Hemoptysis, Weight, and the Use of Opioids and Non-Opioids Analgesics)|Improvement of ≥ 1 tumor related symptom = clinical benefit responder. Pain improvement = decrease of ≥ 1 National Cancer Institute (NCI) grade from baseline of ≥ 1 symptom of NCI pain category, without pain symptom worsening. Cough, dyspnea and hemoptysis improvement = decrease of ≥ 1 NCI grade from baseline. Positive weight change ≥ 5 percent gain from baseline. Positive analgesic consumption = change from baseline from opioid to non-opioid category.|Every 3 weeks for up to 6 months on study treatment|Data were not analyzed.||participants|||Number
708700|NCT00143455|Secondary|European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30)|The EORTC QLQ-C30 scales include 5 functional scales (physical, role, cognitive, emotional, and social), a global health status/QL scale and 9 symptom scales: nausea and vomiting, pain, fatigue, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties. All scales and single-item measures range from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning, for the global health status/QL represents a high QL (better patient state), and for a symptom scale/item represents a high level of symptomatology/problems (worse patient state).|Baseline, at every cycle (Day -1, Day 1 of cycle before treatment), at the end of the treatment, and every 2 months during follow-up|Data were not analyzed.||scores on a scale||Standard Deviation|Mean
708701|NCT00143455|Secondary|Time to Tumor Progression (TTP)|TTP was defined as the time from date of randomization to the date of the first documentation of tumor progression. The Kaplan-Meier method was used to analyze variables of duration and event associated with possible censoring and estimate the medians survival by treatment groups. The confidence intervals for the medians were calculated using the Brookmeyer and Crowley’s method.|Baseline to date of progression (every 9 weeks for up to 6 months on study treatment and every 2 months for a minimum of 13 months post study treatment until progression)|FAP = Full analysis population (all treated patients)analyzed in the arm they were assigned by randomization, assuming they had a confirmed small cell lung cancer. The enrollment of Cohort 1 was terminated early per protocol amendment (29 September 2003). With limited number of subjects in Cohort 1, the efficacy analysis was exploratory.||months||95% Confidence Interval|Median
708702|NCT00143455|Secondary|Duration of Response (DR)|DR was defined as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression. The Kaplan-Meier method was used to analyze variables of duration and event associated with possible censoring and estimate the medians survival by treatment groups. The confidence intervals for the medians were calculated using the Brookmeyer and Crowley’s method.|Baseline to first documentation of confirmed response (every 9 weeks for up to 6 months on study treatment and every 2 months in follow up until progression)|FAP = Full analysis population (all treated patients) of Cohort 2 (after the 29 September 2003 protocol amendment), analyzed in the arm they were assigned by randomization, assuming they had a confirmed small cell lung cancer.||months||95% Confidence Interval|Median
708703|NCT00143455|Primary|Overall Survival for the Per Protocol (PP) Population|OS was defined as the time from date of randomization to date of death due to any cause. For a subject not expiring, the OS time was censored on the last date of contact that they were known to be alive. The Kaplan-Meier method was used to analyze variables of duration and event associated with possible censoring and estimate the medians survival by treatment groups. The confidence intervals for the medians were calculated using the Brookmeyer and Crowley’s method.|Baseline to date of death (every 3 weeks for up to 6 months on study treatment and every 2 months for a minimum of 13 months post study treatment)|PP population = a subset of the Cohort 2 FAP. The subjects had to be eligible (subject had no major protocol deviations from inclusion and noninclusion criteria), evaluable for response, without any major protocol deviations during the study.||months||95% Confidence Interval|Median
708704|NCT00143455|Secondary|Number of Subjects With Overall Confirmed Response|Objective disease response = subjects with confirmed complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all target lesions. A PR was defined as a ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Baseline to first documentation of confirmed response (every 9 weeks for up to 6 months on study treatment and every 2 months in follow up until progression)|FAP = Full analysis population (all treated patients)analyzed in the arm they were assigned by randomization, assuming they had a confirmed small cell lung cancer. The enrollment of Cohort 1 was terminated early per protocol amendment (29 September 2003). With limited number of subjects in Cohort 1, the efficacy analysis was exploratory.||participants|||Number
708705|NCT00143455|Primary|Overall Survival (OS) for the Full Analysis Population (FAP)|OS was defined as the time from date of randomization to date of death due to any cause. For a subject not expiring, the OS time was censored on the last date of contact that they were known to be alive. The Kaplan-Meier method was used to analyze variables of duration and event associated with possible censoring and estimate the medians survival by treatment groups. The confidence intervals for the medians were calculated using the Brookmeyer and Crowley’s method.|Baseline to date of death (every 3 weeks for up to 6 months on study treatment and every 2 months for a minimum of 13 months post study treatment)|FAP = Full analysis population (all treated patients)analyzed in the arm they were assigned by randomization, assuming they had a confirmed small cell lung cancer. The enrollment of Cohort 1 was terminated early per protocol amendment (29 September 2003). With limited number of subjects in Cohort 1, the efficacy analysis was exploratory.||months||95% Confidence Interval|Median
708706|NCT00143507|Secondary|Cardiovascular Death, or Hospitalisation for Acute Myocardial Infarction||From the date of randomisation to the date of the first occurrence of the first event, up to 3 years.|||participants|||Number
708707|NCT00143507|Secondary|Cardiovascular Death, or Hospitalisation for New Onset or Worsening Heart Failure||From the date of randomisation to the date of first occurrence of the first event, up to 3 years.|||participants|||Number
708708|NCT00143507|Secondary|Hospitalisation for Acute Coronary Syndrome, New Onset or Worsening Heart Failure or Coronary Revascularisation||From the date of randomisation to the date of first occurrence of the first event, up to 3 years.|||participants|||Number
708709|NCT00143507|Secondary|Hospitalisation for Acute Coronary Syndrome, or Coronary Revascularisation||From the date of randomisation to the date of first occurrence of the first event, up to 3 years.|||participants|||Number
708710|NCT00143507|Secondary|Hospitalisation for Acute Coronary Syndrome (Unstable Angina or Acute Myocardial Infarction)||From the date of randomisation to the date of first occurrence of the first event, up to 3 years.|||participants|||Number
708711|NCT00143507|Secondary|Hospitalisation for Unstable Angina||From the date of randomisation to the date of first occurrence of the event, up to 3 years.|||participants|||Number
708712|NCT00143507|Secondary|Hospitalisation for Coronary Revascularisation||From the date of randomisation to the date of first occurrence of the event, up to 3 years.|||participants|||Number
708713|NCT00143507|Secondary|Coronary Artery Disease Death|Death due to heart failure, acute myocardial infarction or cardiac procedure|From the date of randomisation to death, up to 3 years.|||participants|||Number
708714|NCT00143507|Secondary|All-cause of Mortality||From the date of randomisation to death, up to 3 years.|||participants|||Number
708715|NCT00143507|Secondary|Hospitalisation for New Onset or Worsening Heart Failure||From the date of randomisation to the date of first occurrence of the event, up to 3 years.|||participants|||Number
708716|NCT00143507|Secondary|Hospitalisation for Acute Myocardial Infarction||From the date of randomisation to the date of first occurrence of the event, up to 3 years.|||Participants|||Number
708717|NCT00143507|Secondary|Cardiovascular Death|Cardiovascular death including sudden death of unknown cause|From the date of randomisation to death, up to 3 years.|||participants|||Number
708719|NCT00143598|Secondary|Quality of Life|"The SF-36 is a well-validated generic quality-of-life (QOL) instrument. It includes questions on both physical and mental health. Higher scores indicate a better QOL. The VEINES-QOL is a venous-disease specific QOL measure that consists of 25 items that quantify venous disease effect on QOL, and an embedded symptom sub-questionnaire (VEINES-Sym) with 10 items that measures venous symptoms. Higher scores are associated with better QOL.
The VEINES-QOL/Sym and SF-36 use the standard method for scoring questionnaires with items with different response scales that is now routinely used. Raw scores are first transformed to z score equivalents (mean, 0; standard deviation, 1), which then are transformed to T scores (mean, 50; standard deviation, 10) to give an easily understood range of scores. A person-specific estimate is imputed for any missing item in cases where the patient answered at least 50% of the items in the scale."|24 months|Patients who completed the SF-36 and VEINES-QOL at 24 months follow-up.||Scores on a scale||Standard Deviation|Mean
708720|NCT00143598|Secondary|Incidence of Objectively Confirmed Recurrent Venous Thromboembolism (VTE), Death From VTE and Major Bleeding||During 2-year follow up|||participants|||Number
708721|NCT00143598|Secondary|Severity of PTS, Including Incidence of Venous Ulcer|"Highest Villalta at or after 6 month visit
The Villalta Scale for assessment of the post-thrombotic syndrome The Villalta scale has a range of 0-33. A Villalta scale score >4 indicates post-thrombotic syndrome (severity of post-thrombotic syndrome is categorized as 5-9 points, mild; 10-14 points, moderate; >14 points or presence of an ulcer, severe).
Higher values signify worse outcome. Points on each item in the scale are simply summed to a total score."|6-24 months.|Highest Villalta score at or after 6 month visit (missing for 48 patients in each group).||participants|||Number
708722|NCT00143598|Primary|Incidence of Post-thrombotic Syndrome (PTS)||During 2-year follow up|Intention to treat.||participants|||Number
708723|NCT00143819|Secondary|Photography of Target Lesions|Number of participants with photographs taken|8 weeks|Thirteen (13) subjects were randomized to receive Neuroskin Forte (ie, active) spray on one side of the body and placebo spray on the other side of the body.||Participants|||Count of Participants
708724|NCT00143819|Secondary|Change in Target Lesion Scoring|The subjects' target lesions (ie, a pair of roughly symmetrical bilateral lesions) on each side of the body were scored by the investigator at each visit. Percent change from baseline was calculated.|8 weeks|Thirteen (13) subjects were randomized to receive Neuroskin Forte (ie, active) spray on one side of the body and placebo spray on the other side of the body.||percent change||Standard Deviation|Mean
708725|NCT00143819|Secondary|Number of Participants With an Eczema ½-Body Investigator Global Assessment (IGA) Improvement of at Least 2 Levels|For subjects with eczema, a global assessment (scale of 0-5: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe; 5 = very severe) was performed and a score recorded for each side of the subject's body, at each visit.|8 weeks|The five (5) subjects in the study who had eczema were randomized to receive Neuroskin Forte (ie, active) spray on one side of the body and placebo spray on the other side of the body.||Participants|||Count of Participants
708726|NCT00143819|Secondary|Number of Participants With a Psoriasis ½-Body Physician Global Assessment (PGA) Improvement of at Least 2 Levels|For subjects with psoriasis, a global assessment (scale of 0-5: 0 = clear except for residual discoloration; 1 = minimal; 2 = mild; 3 = moderate; 4 = marked; 5 = severe) was performed and a score recorded for each side of the subject's body, at each visit.|8 weeks|The eight (8) subjects in the study who had psoriasis were randomized to receive Neuroskin Forte (ie, active) spray on one side of the body and placebo spray on the other side of the body.||Participants|||Count of Participants
708727|NCT00143819|Primary|Change From Baseline in the Visual Analog Scale (VAS) Score for Pruritus (Itching) at 8 Weeks|Subjects assessed the level of pruritus (itching) on the left and right sides of their body at each visit, ticking the values on a 100-mm scale (0 mm = no itching; 100 mm = worst possible itching) for each side. Percent change from baseline was calculated.|8 weeks|Thirteen (13) subjects were randomized to receive Neuroskin Forte (ie, active) spray on one side of the body and placebo spray on the other side of the body.||percent change||Standard Deviation|Mean
708728|NCT00143845|Secondary|Percentage of Patients Alive at 2 Years|To estimate the overall survival of patients progression following prophylactic cellular immunotherapy after allogeneic hematopoietic stem cell therapy using low intensity conditioning for high-risk hematological malignancies.|2 Years|54 patients were enrolled however 9 patients did not receive planned donor lymphocyte infusion. 45 patients were analyzed.||percentage of participants|||Number
708729|NCT00143845|Primary|Percentage of Participants With Progression Free Survival|"The second primary objective was to determine the percentage of participants with progression free survival following prophylactic cellular immunotherapy after allogeneic hematopoietic stem cell therapy using low intensity conditioning for high-risk hematological malignancies.
We define disease progression as disease recurrence within 180 days of transplant."|two years|54 patients were enrolled however 9 patients did not receive planned donor lymphocyte infusion. 45 patients were analyzed.||percentage of participants|||Number
708730|NCT00143845|Primary|Percentage of Participants With Acute Graft Versus Host Disease (GVHD) Grades 2-4|"The primary objective of this study was to establish the rate of acute GVHD following prophylactic cellular immunotherapy after allogeneic hematopoietic stem cell therapy using low intensity conditioning for high-risk hematological malignancies. Glucksberg staging was used for organ grading of GVHD. Clinical GVHD was assessed as follows:
Grade 0: No stage 1-4 of any organ Grade 1: Stage 1-2 rash and no liver or gut involvement Grade 2: Stage 3 rash, or Stage 1 liver involvement, or Stage 1 GI Grade 3: Stage 0-3 skin with Stage 2-3 liver, or Stage 2-4 GI Grade 4: Stage 4 skin rash, or Stage 4 liver involvement"|100 days|54 patients were enrolled however 9 patients did not receive planned donor lymphocyte infusion. 45 patients were analyzed.||percentage of participants|||Number
708731|NCT00144027|Primary|Antipsychotic Medication Adherence|The self-report adherence measure asked patients to think about the past four weeks and report to what extent they took their medication for mental, emotional, or nervous problems and report the result on a 5-point Likert scale ranging from ‘I never missed taking my medicine’ to ‘I stopped taking the medicine altogether’. Patients who received depot injections were asked to think about the past six months. Self-report adherence was defined as 1=I never missed taking my medicine’ and 0=any other response to the medication adherence question.|6-months|"Percent of participants who reported never missed taking my medication at 6-months"||percentage of participants|||Number
714981|NCT00247273|Secondary|Change From Baseline in Serum BAP at Month 24, ITT Population|Assayed by ELISA (enzyme-linked immunosorbent assay)|Baseline to Month 24|ITT||ug / L||95% Confidence Interval|Least Squares Mean
708732|NCT00144170|Secondary|Time to New Centers for Disease Control (CDC) Class C Progression Event or Death.|"Time to death or occurrence of AIDS-defining condition according to the US Centers for Disease Control and Prevention case definition.
The median and quartiles are underestimated since more than 92% of the observations (in both treatment arms) were censored and the estimation was restricted to the largest observed event time."|up to 75 weeks of treatment|Safety Set (SAF), included all patients treated with at least one dose of study medication||Days||Inter-Quartile Range|Median
708733|NCT00144170|Secondary|Mean Change From Baseline in CD4+ Cell Count (Week 96)||Baseline to Week 96|Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count||Cells/mm3||Standard Deviation|Mean
708734|NCT00144170|Secondary|Mean Change From Baseline in CD4+ Cell Count (Week 88)||Baseline to Week 88|Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count||Cells/mm3||Standard Deviation|Mean
708735|NCT00144170|Secondary|Mean Change From Baseline in CD4+ Cell Count (Week 80)||Baseline to Week 80|Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count||Cells/mm3||Standard Deviation|Mean
708736|NCT00144170|Secondary|Mean Change From Baseline in CD4+ Cell Count (Week 72)||Baseline to Week 72|Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count||Cells/mm3||Standard Deviation|Mean
708737|NCT00144170|Secondary|Mean Change From Baseline in CD4+ Cell Count (Week 64)||Baseline to Week 64|Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count||Cells/mm3||Standard Deviation|Mean
708738|NCT00144170|Secondary|Mean Change From Baseline in CD4+ Cell Count (Week 56)||Baseline to Week 56|Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count||Cells/mm3||Standard Deviation|Mean
708739|NCT00144170|Secondary|Mean Change From Baseline in CD4+ Cell Count (Week 48)||Baseline to Week 48|Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count||Cells/mm3||Standard Deviation|Mean
708740|NCT00144170|Secondary|Mean Change From Baseline in CD4+ Cell Count (Week 40)||Baseline to Week 40|Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count||Cells/mm3||Standard Deviation|Mean
708741|NCT00144170|Secondary|Mean Change From Baseline in CD4+ Cell Count (Week 32)||Baseline to Week 32|Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count||Cells/mm3||Standard Deviation|Mean
708742|NCT00144170|Secondary|Mean Change From Baseline in CD4+ Cell Count (Week 24)||Baseline to Week 24|Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count||Cells/mm3||Standard Deviation|Mean
708743|NCT00144170|Secondary|Mean Change From Baseline in CD4+ Cell Count (Week 16)||Baseline to Week 16|Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count||Cells/mm3||Standard Deviation|Mean
708744|NCT00144170|Secondary|Mean Change From Baseline in CD4+ Cell Count (Week 8)||Baseline to Week 8|Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count||Cells/mm3||Standard Deviation|Mean
708745|NCT00144170|Secondary|Mean Change From Baseline in CD4+ Cell Count (Week 4)||Baseline to Week 4|Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count||Cells/mm3||Standard Deviation|Mean
708746|NCT00144170|Secondary|Mean Change From Baseline in CD4+ Cell Count (Week 2)||Baseline to Week 2|Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count||Cells/mm3||Standard Deviation|Mean
708747|NCT00144170|Secondary|Virologic Response at Week 96|Virologic response defined as Viral Load<50 copies/mL|Week 96|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
708748|NCT00144170|Secondary|Virologic Response at Week 88|Virologic response defined as Viral Load<50 copies/mL|Week 88|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
708749|NCT00144170|Secondary|Virologic Response at Week 80|Virologic response defined as Viral Load<50 copies/mL|Week 80|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
708750|NCT00144170|Secondary|Virologic Response at Week 72|Virologic response defined as Viral Load<50 copies/mL|Week 72|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
708751|NCT00144170|Secondary|Virologic Response at Week 64|Virologic response defined as Viral Load<50 copies/mL|Week 64|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
708752|NCT00144170|Secondary|Virologic Response at Week 56|Virologic response defined as Viral Load<50 copies/mL|Week 56|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
708753|NCT00144170|Secondary|Virologic Response at Week 48|Virologic response defined as Viral Load<50 copies/mL|Week 48|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
708754|NCT00144170|Secondary|Virologic Response at Week 40|Virologic response defined as Viral Load<50 copies/mL|Week 40|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
708755|NCT00144170|Secondary|Virologic Response at Week 32|Virologic response defined as Viral Load<50 copies/mL|Week 32|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
714982|NCT00247273|Secondary|Percent Change From Baseline in Serum BAP at Month 6, ITT Population|Assayed by ELISA (enzyme-linked immunosorbent assay)|Baseline to Month 6|ITT||Percent Change||95% Confidence Interval|Least Squares Mean
708767|NCT00144170|Secondary|Virologic Response at Week 56|Virologic response defined as Viral Load<400 copies/mL|Week 56|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
708768|NCT00144170|Secondary|Virologic Response at Week 48|Virologic response defined as Viral Load<400 copies/mL|Week 48|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
708769|NCT00144170|Secondary|Virologic Response at Week 32|Virologic response defined as Viral Load<400 copies/mL|Week 32|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
708770|NCT00144170|Secondary|Virologic Response at Week 24|Virologic response defined as Viral Load<400 copies/mL|Week 24|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
708771|NCT00144170|Secondary|Virologic Response at Week 16|Virologic response defined as Viral Load<400 copies/mL|Week 16|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
708772|NCT00144170|Secondary|Virologic Response at Week 8|Virologic response defined as Viral Load<400 copies/mL|Week 8|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
708773|NCT00144170|Secondary|Virologic Response at Week 4|Virologic response defined as Viral Load<400 copies/mL|Week 4|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
708774|NCT00144170|Secondary|Virologic Response at Week 2|Virologic response defined as Viral Load<400 copies/mL|Week 2|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
708775|NCT00144170|Secondary|Virologic Response at Viral Load Nadir During Study Treatment Through 96 Weeks|Virologic response defined as Viral Load<400 copies/mL|Week 2 through Week 96 (at any point during trial)|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
708776|NCT00144170|Secondary|Virologic Response at Week 40|Virologic response defined as Viral Load<400 copies/mL|Week 40|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
708777|NCT00144170|Secondary|Median Change From Baseline in Viral Load (Week 96)||Baseline to Week 96|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Log(Copies/mL)||Inter-Quartile Range|Median
708778|NCT00144170|Secondary|Median Change From Baseline in Viral Load (Week 88)||Baseline to Week 88|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Log(Copies/mL)||Inter-Quartile Range|Median
708779|NCT00144170|Secondary|Median Change From Baseline in Viral Load (Week 80)||Baseline to Week 80|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Log(Copies/mL)||Inter-Quartile Range|Median
708780|NCT00144170|Secondary|Median Change From Baseline in Viral Load (Week 72)||Baseline to Week 72|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Log(Copies/mL)||Inter-Quartile Range|Median
708781|NCT00144170|Secondary|Median Change From Baseline in Viral Load (Week 64)||Baseline to Week 64|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Log(Copies/mL)||Inter-Quartile Range|Median
708782|NCT00144170|Secondary|Median Change From Baseline in Viral Load (Week 56)||Baseline to Week 56|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Log(Copies/mL)||Inter-Quartile Range|Median
708783|NCT00144170|Secondary|Median Change From Baseline in Viral Load (Week 48)||Baseline to Week 48|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Log(Copies/mL)||Inter-Quartile Range|Median
708784|NCT00144170|Secondary|Median Change From Baseline in Viral Load (Week 40)||Baseline to Week 40|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Log(Copies/mL)||Inter-Quartile Range|Median
708785|NCT00144170|Secondary|Median Change From Baseline in Viral Load (Week 32)||Baseline to Week 32|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Log(Copies/mL)||Inter-Quartile Range|Median
708786|NCT00144170|Secondary|Median Change From Baseline in Viral Load (Week 24)||Baseline to Week 24|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Log(Copies/mL)||Inter-Quartile Range|Median
708787|NCT00144170|Secondary|Median Change From Baseline in Viral Load (Week 16)||Baseline to Week 16|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Log(Copies/mL)||Inter-Quartile Range|Median
708788|NCT00144170|Secondary|Median Change From Baseline in Viral Load (Week 8)||Baseline to Week 8|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Log(Copies/mL)||Inter-Quartile Range|Median
708789|NCT00144170|Secondary|Median Change From Baseline in Viral Load (Week 4)||Baseline to Week 4|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Log(Copies/mL)||Inter-Quartile Range|Median
708790|NCT00144170|Secondary|Median Change From Baseline in Viral Load (Week 2)||Baseline to Week 2|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Log(Copies/mL)||Inter-Quartile Range|Median
708791|NCT00144170|Secondary|Virologic Response at Week 96|Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1|Week 96|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
708792|NCT00144170|Secondary|Virologic Response at Week 88|Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1|Week 88|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
708793|NCT00144170|Secondary|Virologic Response at Week 80|Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1|Week 80|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
708794|NCT00144170|Secondary|Virologic Response at Week 72|Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1|Week 72|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
708795|NCT00144170|Secondary|Virologic Response at Week 64|Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1|week 64|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
708796|NCT00144170|Secondary|Virologic Response at Week 56|Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1|week 56|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
708797|NCT00144170|Secondary|Virologic Response at Week 48|Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1|week 48|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
708798|NCT00144170|Secondary|Virologic Response at Week 40|Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1|week 40|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
708799|NCT00144170|Secondary|Virologic Response at Week 32|Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1|week 32|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
708800|NCT00144170|Secondary|Virologic Response at Week 24|Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1|week 24|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
708801|NCT00144170|Secondary|Virologic Response at Week 16|Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1|week 16|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
708802|NCT00144170|Secondary|Virologic Response at Week 8|Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1|week 8|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
708803|NCT00144170|Secondary|Virologic Response at Week 4|Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1|week 4|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
708804|NCT00144170|Secondary|Virologic Response at Week 2|Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1|Week 2|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
708805|NCT00144170|Secondary|Virologic Response|Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1|Week 2 through Week 96 (at any point during trial)|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
708806|NCT00144170|Secondary|Time to Confirmed Virologic Failure Through 96 Weeks of Treatment|Time to virologic failure is defined as the time from the start of treatment to the last measurement where the Log(baseline viral load)-Log(on-treatment viral load)>1 before a 2 consecutive measurements where Log(baseline viral load)-Log(on-treatment viral load)<1.|after 96 weeks of treatment|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Days||Inter-Quartile Range|Median
708807|NCT00144170|Secondary|Time to Confirmed Virologic Failure Through 48 Weeks of Treatment|Time to virologic failure is defined as the time from the start of treatment to the last measurement where the Log(baseline viral load)-Log(on-treatment viral load)>1 before a 2 consecutive measurements where Log(baseline viral load)-Log(on-treatment viral load)<1.|after 48 weeks of treatment|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Days||Inter-Quartile Range|Median
708808|NCT00144170|Secondary|Time to Treatment Failure Through 96 Weeks of Treatment|Time to treatment failure is defined as 0 for patients who never achieve TR otherwise time to treatment failure is the earliest time of death, discontinuation of the study drug or introduction of a new anti-retroviral drug to the regimen if it is not solely related to either toxicity or intolerance clearly attributable to a background, or the first of two consecutive visits with Log(baseline Viral Load) - Log(on-treatment Viral Load) < 1.|after 96 weeks of treatment|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Days||Inter-Quartile Range|Median
708809|NCT00144170|Secondary|Treatment Response at Week 96|Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|after 96 weeks of treatment|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||percentage of participants|||Number
708810|NCT00144170|Secondary|Treatment Response at Week 88|Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 88|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||percentage of participants|||Number
708811|NCT00144170|Secondary|Treatment Response at Week 80|Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 80|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||percentage of participants|||Number
708812|NCT00144170|Secondary|Treatment Response at Week 72|Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 72|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||percentage of participants|||Number
708831|NCT00144300|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Total Score at 2 Years|Part III of the UPDRS contained the clinician-scored motor evaluation. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56.|2 years|TS - treated set||Score on a scale||Standard Deviation|Mean
708813|NCT00144170|Secondary|Treatment Response at Week 64|Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 64|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||percentage of participants|||Number
708814|NCT00144170|Secondary|Treatment Response at Week 56|Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 56|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||percentage of participants|||Number
708815|NCT00144170|Secondary|Treatment Response at Week 40|Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 40|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||percentage of participants|||Number
708816|NCT00144170|Secondary|Treatment Response at Week 32|Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 32|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||percentage of participants|||Number
708817|NCT00144170|Secondary|Treatment Response at Week 24|Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|Week 24|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||percentage of participants|||Number
708818|NCT00144170|Secondary|Treatment Response at Week 16|Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 16|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||percentage of participants|||Number
708819|NCT00144170|Secondary|Treatment Response at Week 8|Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 8|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
708820|NCT00144170|Secondary|Treatment Response at Week 4|Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 4|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||percentage of participants|||Number
708821|NCT00144170|Secondary|Treatment Response at Week 2|Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 2|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||percentage of participants|||Number
708822|NCT00144170|Primary|Time to Treatment Failure Through 48 Weeks of Treatment|Time to treatment failure is defined as 0 for patients who never achieve TR otherwise time to treatment failure is the earliest time of death, discontinuation of the study drug or introduction of a new anti-retroviral drug to the regimen if it is not solely related to either toxicity or intolerance clearly attributable to a background, or the first of two consecutive visits with Log(baseline Viral Load) - Log(on-treatment Viral Load) < 1.|after 48 weeks of treatment|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Days||Inter-Quartile Range|Median
708823|NCT00144170|Primary|Treatment Response at Week 48|Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|after 48 weeks of treatment|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||percentage of participants|||Number
708824|NCT00144300|Secondary|Clinical Abnormal Findings: Clinical Laboratory Evaluations (Biochemistry and Haematology)and Vital Signs|Clinical relevant abnormalities for clinical laboratory evaluations Biochemistry and Haematology) and Vital Signs. New abnormal findings or worsening of baseline conditions were reported.|Screen (Baseline) and final visit (24 months)|TSlab - treated set with non-missing laboratory evaluations||participants|||Number
708825|NCT00144300|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Change From Baseline in Total Score at 2 Years|This is the sum of Part II and Part III of the UPDRS. The total score ranged from 0 (Normal) to 108 (Extreme dysfunction).|Baseline, 2 year|TS - treated set||Score on a scale||Standard Deviation|Mean
708826|NCT00144300|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Total Score at 2 Years|This is the sum of Part II and Part III of the UPDRS. The total score ranged from 0 (Normal) to 108 (Extreme dysfunction).|2 years|TS - treated set||Score on a scale||Standard Deviation|Mean
708827|NCT00144300|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Change From Baseline in Total Score at 1 Year|This is the sum of Part II and Part III of the UPDRS. The total score ranged from 0 (Normal) to 108 (Extreme dysfunction).|Baseline, 1 year|TS - treated set||Score on a scale||Standard Deviation|Mean
708828|NCT00144300|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Total Score at 1 Year|This is the sum of Part II and Part III of the UPDRS. The total score ranged from 0 (Normal) to 108 (Extreme dysfunction).|1 year|TS - treated set||Score on a scale||Standard Deviation|Mean
708829|NCT00144300|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Total Score at Baseline|This is the sum of Part II and Part III of the UPDRS. The total score ranged from 0 (Normal) to 108 (Extreme dysfunction).|Baseline|TS - treated set||Score on a scale||Standard Deviation|Mean
708830|NCT00144300|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Change From Baseline in Total Score at 2 Years|Part III of the UPDRS contained the clinician-scored motor evaluation. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56.|Baseline, 2 year|TS - treated set||Score on a scale||Standard Deviation|Mean
708832|NCT00144300|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Change From Baseline in Total Score at 1 Year|Part III of the UPDRS contained the clinician-scored motor evaluation. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56.|Baseline, 1 year|TS - treated set||Score on a scale||Standard Deviation|Mean
708833|NCT00144300|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Total Score at 1 Year|Part III of the UPDRS contained the clinician-scored motor evaluation. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56.|1 year|TS - treated set||Score on a scale||Standard Deviation|Mean
708834|NCT00144300|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Total Score at Baseline|Part III of the UPDRS contained the clinician-scored motor evaluation. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56.|Baseline|TS - treated set||Score on a scale||Standard Deviation|Mean
708835|NCT00144300|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Change From Baseline in Total Score at 2 Years|Part II of the UPDRS collected retrospective information on patient functioning in various activities of daily living. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 52.|Baseline, 2 year|TS - treated set||Score on a scale||Standard Deviation|Mean
708836|NCT00144300|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at 2 Years|Part II of the UPDRS collected retrospective information on patient functioning in various activities of daily living. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 52.|2 years|TS - treated set||Score on a scale||Standard Deviation|Mean
708837|NCT00144300|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Change From Baseline in Total Score at 1 Year|Part II of the UPDRS collected retrospective information on patient functioning in various activities of daily living. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 52.|Baseline, 1 year|TS - treated set||Score on a scale||Standard Deviation|Mean
708838|NCT00144300|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at 1 Year|Part II of the UPDRS collected retrospective information on patient functioning in various activities of daily living. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 52.|1 year|TS - treated set||Score on a scale||Standard Deviation|Mean
708839|NCT00144300|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at Baseline|Part II of the UPDRS collected retrospective information on patient functioning in various activities of daily living. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 52.|Baseline|TS - treated set||Score on a scale||Standard Deviation|Mean
708840|NCT00144300|Secondary|Hoehn and Yahr Scale at 2 Years|This scale is an investigator-completed assessment of the degree of complications arising from Parkinson's disease. The scale ranges from 0 (No signs) to 5 (Bedridden)|Up to 2 years|TS - treated set||Participants|||Number
708841|NCT00144300|Secondary|Hoehn and Yahr Scale at 1 Year|This scale is an investigator-completed assessment of the degree of complications arising from Parkinson's disease. The scale ranges from 0 (No signs) to 5 (Bedridden)|Up to 1 year|TS - treated set||Participants|||Number
708842|NCT00144300|Secondary|Hoehn and Yahr Scale at Baseline|This scale is an investigator-completed assessment of the degree of complications arising from Parkinson's disease. The scale ranges from 0 (No signs) to 5 (Bedridden)|Baseline|TS - treated set||Participants|||Number
708843|NCT00144300|Secondary|Expert Panel Overall Assessment Following 1 Year on Drug|Expert panel of ophthalmologists assessed retinal deterioration by a review of the components of the comprehensive ophthalmology assessments|up to 1 years|FAS LOCF - full analysis set with last observation carry forward||Participants|||Number
708844|NCT00144300|Primary|Expert Panel Overall Assessment Following 2 Years on Drug|Expert panel of ophthalmologists assessed retinal deterioration by a review of the components of the comprehensive ophthalmology assessments|up to 2 years|FAS LOCF - full analysis set with last observation carry forward||Participants|||Number
708845|NCT00144339|Other Pre-specified|Incidence Rate of Serious Adverse Event (Preferred Term = Respiratory Failure)|Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.|Day 1 to completion of double blinded treatment plus 30 days|||Number of patients with event|||Number
708846|NCT00144339|Other Pre-specified|Incidence Rate of Serious Adverse Event (Preferred Term = Pneumonia)|Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.|Day 1 to completion of double blinded treatment plus 30 days|||Number of patients with event|||Number
708847|NCT00144339|Other Pre-specified|Incidence Rate of Serious Adverse Event (Preferred Term = Dyspnoea)|Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.|Day 1 to completion of double blinded treatment plus 30 days|||Number of patients with event|||Number
708848|NCT00144339|Other Pre-specified|Incidence Rate of Serious Adverse Event (Preferred Term = Chronic Obstructive Pulmonary Disease (COPD) Exacerbation)|Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.|Day 1 to completion of double blinded treatment plus 30 days|||Number of patients with event|||Number
708849|NCT00144339|Other Pre-specified|Incidence Rate of Serious Adverse Event (Preferred Term = Bronchitis)|Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.|Day 1 to completion of double blinded treatment plus 30 days|||Number of patients with event|||Number
708850|NCT00144339|Other Pre-specified|Incidence Rate of Serious Adverse Event (System Organ Class = Lower Respiratory System Disorders)|Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.|Day 1 to completion of double blinded treatment plus 30 days|||Number of patients with event|||Number
708911|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 36||Month 36|||L||Standard Error|Mean
708851|NCT00144339|Other Pre-specified|Incidence Rate of Serious Adverse Event (Preferred Term = Myocardial Infarction)|Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.|Day 1 to completion of double blinded treatment plus 30 days|||Number of patients with event|||Number
708852|NCT00144339|Other Pre-specified|Incidence Rate of Serious Adverse Event (Preferred Term = Coronary Artery Disease)|Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.|Day 1 to completion of double blinded treatment plus 30 days|||Number of patients with event|||Number
708853|NCT00144339|Other Pre-specified|Incidence Rate of Serious Adverse Event (Preferred Term = Cardiac Failure Congestive)|Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.|Day 1 to completion of double blinded treatment plus 30 days|||Number of patients with event|||Number
708854|NCT00144339|Other Pre-specified|Incidence Rate of Serious Adverse Event (Preferred Term = Cardiac Failure)|Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.|Day 1 to completion of double blinded treatment plus 30 days|||Number of patients with event|||Number
708855|NCT00144339|Other Pre-specified|Incidence Rate of Serious Adverse Event (Preferred Term = Atrial Fibrillation)|Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.|Day 1 to completion of double blinded treatment plus 30 days|||Number of patients with event|||Number
708856|NCT00144339|Other Pre-specified|Incidence Rate of Serious Adverse Event (Preferred Term = Angina)|Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.|Day 1 to completion of double blinded treatment plus 30 days|||Number of patients with event|||Number
708857|NCT00144339|Other Pre-specified|Incidence Rate of Serious Adverse Event (System Organ Class = Cardiac Disorders)|Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.|Day 1 to completion of double blinded treatment plus 30 days|||Number of patients with event|||Number
708858|NCT00144339|Secondary|Number and Percentage of Participants With a Lower Respiratory Death (Adjudicated; Including Vital Status Follow-up, Cutoff at 1470 Days)|The primary cause of death was adjudicated by an external committee prior to unblinding; vital status was information followed-up after discontinuation; vital status information up to 1470 days after the start of treatment was used|Day 1 to day 1470|||Participants|||Number
708859|NCT00144339|Secondary|Number and Percentage of Participants With Lower Respiratory Death (On-treatment; Adjudicated Primary Cause)|The primary cause of death was adjudicated by an external committee prior to unblinding; on-treatment defined as day 1 to completion of double blinded treatment plus 30 days|Day 1 to completion of double blinded treatment plus 30 days between Day 1 and 4 years plus 30 days|||Participants|||Number
708860|NCT00144339|Secondary|Number and Percentage of Participants With All Cause Death (Including Vital Status Follow-up, Cutoff at 1470 Days)|All cause mortality vital status information was followed-up after discontinuation; vital status information up to 1470 days after the start of treatment was used.|Day 1 to day 1470|||Participants|||Number
708861|NCT00144339|Post-Hoc|Number and Percentage of Participants With All Cause Death (Including Vital Status Follow-up, Cutoff at 1440 Days)||Day 1 to day 1440|||Participants|||Number
708862|NCT00144339|Secondary|Number and Percentage of Participants With All Cause Death and Time to Event Analysis (On-treatment)|On-treatment defined as day 1 to completion of double blinded treatment plus 30 days|Day 1 to completion of double blinded treatment plus 30 days between Day 1 and 4 years plus 30 days|||Participants|||Number
708863|NCT00144339|Secondary|Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 48|"SGRQ total score summarizes the impact of COPD on overall patient's health status.
Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
The scale is continuous.
Rate of decline shows the yearly change of SGRQ total score."|Month 48|||Units on a scale||Standard Error|Mean
708864|NCT00144339|Secondary|Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 42|"SGRQ total score summarizes the impact of COPD on overall patient's health status.
Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
The scale is continuous.
Rate of decline shows the yearly change of SGRQ total score."|Month 42|||Units on a scale||Standard Error|Mean
708865|NCT00144339|Secondary|Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 36|"SGRQ total score summarizes the impact of COPD on overall patient's health status.
Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
The scale is continuous.
Rate of decline shows the yearly change of SGRQ total score."|Month 36|||Units on a scale||Standard Error|Mean
708866|NCT00144339|Secondary|Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 30|"SGRQ total score summarizes the impact of COPD on overall patient's health status.
Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
The scale is continuous.
Rate of decline shows the yearly change of SGRQ total score."|Month 30|||Units on a scale||Standard Error|Mean
708867|NCT00144339|Secondary|Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 24|"SGRQ total score summarizes the impact of COPD on overall patient's health status.
Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
The scale is continuous.
Rate of decline shows the yearly change of SGRQ total score."|Month 24|||Units on a scale||Standard Error|Mean
708912|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 36||Month 36|||L||Standard Error|Mean
708913|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 30||Month 30|||L||Standard Error|Mean
708868|NCT00144339|Secondary|Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 18|"SGRQ total score summarizes the impact of COPD on overall patient's health status.
Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
The scale is continuous.
Rate of decline shows the yearly change of SGRQ total score."|Month 18|||Units on a scale||Standard Error|Mean
708869|NCT00144339|Secondary|Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 12|"SGRQ total score summarizes the impact of COPD on overall patient's health status.
Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
The scale is continuous.
Rate of decline shows the yearly change of SGRQ total score."|Month 12|||Units on a scale||Standard Error|Mean
708870|NCT00144339|Secondary|Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 6|"SGRQ total score summarizes the impact of COPD on overall patient's health status.
Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
The scale is continuous.
Rate of decline shows the yearly change of SGRQ total score."|Month 6|||Units on a scale||Standard Error|Mean
708871|NCT00144339|Secondary|Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 48||Month 48|||L||Standard Error|Mean
708872|NCT00144339|Secondary|Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 48||Month 48|||L||Standard Error|Mean
708873|NCT00144339|Secondary|Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 42||Month 42|||L||Standard Error|Mean
708874|NCT00144339|Secondary|Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 42||Month 42|||L||Standard Error|Mean
708875|NCT00144339|Secondary|Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 36||Month 36|||L||Standard Error|Mean
708876|NCT00144339|Secondary|Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 36||Month 36|||L||Standard Error|Mean
708877|NCT00144339|Secondary|Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 30||Month 30|||L||Standard Error|Mean
708878|NCT00144339|Secondary|Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 30||Month 30|||L||Standard Error|Mean
708879|NCT00144339|Secondary|Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 24||Month 24|||L||Standard Error|Mean
708880|NCT00144339|Secondary|Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 24||Month 24|||L||Standard Error|Mean
708881|NCT00144339|Secondary|Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 18||Month 18|||L||Standard Error|Mean
708882|NCT00144339|Secondary|Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 18||Month 18|||L||Standard Error|Mean
708883|NCT00144339|Secondary|Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 12||Month 12|||L||Standard Error|Mean
708884|NCT00144339|Secondary|Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 12||Month 12|||L||Standard Error|Mean
708885|NCT00144339|Secondary|Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 6||Month 6|||L||Standard Error|Mean
708886|NCT00144339|Secondary|Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 6||Month 6|||L||Standard Error|Mean
708887|NCT00144339|Secondary|Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 1||Month 1|||L||Standard Error|Mean
708888|NCT00144339|Secondary|Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 1||Month 1|||L||Standard Error|Mean
708889|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 48||Month 48|||L||Standard Error|Mean
708890|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 48||Month 48|||L||Standard Error|Mean
708891|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 42||Month 42|||L||Standard Error|Mean
708892|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 42||Month 42|||L||Standard Error|Mean
708893|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 36||Month 36|||L||Standard Error|Mean
708894|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 36||Month 36|||L||Standard Error|Mean
708895|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 30||Month 30|||L||Standard Error|Mean
708896|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 30||Month 30|||L||Standard Error|Mean
708897|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 24||Month 24|||L||Standard Error|Mean
708898|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 24||Month 24|||L||Standard Error|Mean
708899|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 18||Month 18|||L||Standard Error|Mean
708900|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 18||Month 18|||L||Standard Error|Mean
708901|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 12||Month 12|||L||Standard Error|Mean
708902|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 12||Month 12|||L||Standard Error|Mean
708903|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 6||Month 6|||L||Standard Error|Mean
708904|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 6||Month 6|||L||Standard Error|Mean
708905|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 1||Month 1|||L||Standard Error|Mean
708906|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 1||Month 1|||L||Standard Error|Mean
708907|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 48||Month 48|||L||Standard Error|Mean
708908|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 48||Month 48|||L||Standard Error|Mean
708909|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 42|Estimated FEV1 after bronchodilator at Month 42|Month 42|||L||Standard Error|Mean
708910|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 42||Month 42|||L||Standard Error|Mean
708925|NCT00144339|Secondary|Days of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Leading to Hospitalization|Number of days with chronic obstructive pulmonary disease (COPD) exacerbation leading to hospitalization (normalized by treatment exposure)|From Day 1 to 4 years|||days/patient year||Standard Error|Mean
708926|NCT00144339|Secondary|Number of Exacerbation Leading to Hospitalization|Estimated number of exacerbations leading to hospitalizations per patient year|From Day 1 to 4 years|||Number per patient year|||Number
708927|NCT00144339|Secondary|Number and Percentage of Patients With at Least on COPD Exacerbation Leading to Hospitalization||From Day 1 to 4 years|||Participants|||Number
708928|NCT00144339|Secondary|Time to First COPD Exacerbation Leading to Hospitalization (for 25% Patients)||Day 1 to 4 years|||months||95% Confidence Interval|Median
708929|NCT00144339|Secondary|Number of Exacerbation Days Per Patient Year|Number of exacerbation days normalized by treatment exposure|Day 1 to 4 years|||days/patient year||Standard Error|Mean
708930|NCT00144339|Secondary|Number and Percentage of Patients With at Least One Chronic Obstructive Pulmonary Disease (COPD) Exacerbation||Day 1 to 4 years|||Participants|||Number
708931|NCT00144339|Secondary|Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Patient Year||Day 1 to 4 years|||number per patient year||Standard Error|Mean
708932|NCT00144339|Secondary|Time to First Exacerbation|Chronic obstructive pulmonary disease (COPD) exacerbation|From Day 1 to 4 years|||months||95% Confidence Interval|Median
708933|NCT00144339|Secondary|Post-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment|Rate of decline of slow vital capacity (SVC) after bronchodilation. A negative rate of decline indicates decreasing SVC over time, while a positive value indicates increasing SVC|Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days|||ml/year||Standard Error|Median
708934|NCT00144339|Secondary|Pre-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment|Rate of decline slow vital capacity (SVC) before bronchodilation. A negative rate of decline indicates decreasing SVC over time, while a positive value indicates increasing SVC|Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days|||ml/year||Standard Error|Median
708935|NCT00144339|Secondary|Post-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment|Rate of decline of forced vital capacity (FVC) after bronchodilation. A negative rate of decline indicates decreasing FVC over time, while a positive value indicates increasing FVC|Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days|||ml/year||Standard Error|Median
708936|NCT00144339|Secondary|Pre-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment|Rate of decline of forced vital capacity (FVC) before bronchodilation. A negative rate of decline indicates decreasing FVC over time, while a positive value indicates increasing FVC|Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days.|||ml/year||Standard Error|Median
708937|NCT00144339|Secondary|Rate of Decline of St George's Respiratory Questionnaire (SGRQ) Total Score|SGRQ total score shows the impact of COPD on patient's health status, and expressed as a percentage of impairment with scale from 0 (best health status) to 100 (worst possible status). A negative rate of decline shows decreasing SGRQ total score (or improved health) over time, while a positive value shows increasing score (or worsen health).|From month 6 to 4 years|||Score on scale per year||Standard Error|Mean
708938|NCT00144339|Secondary|Post-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 30 to 4 Years|Rate of decline of slow vital capacity (SVC) measured after bronchodilation. A negative rate of decline indicates decreasing SVC over time, while a positive value indicates increasing SVC|From day 30 to 4 years|||ml/year||Standard Error|Mean
708939|NCT00144339|Secondary|Pre-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 30 to 4 Years|Rate of decline of slow vital capacity (SVC) measured before the use of bronchodilators. A negative rate of decline indicates decreasing SVC over time, while a positive value indicates increasing SVC|From day 30 to 4 years|||ml/year||Standard Error|Mean
708940|NCT00144339|Secondary|Post-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 30 to 4 Years|Rate of decline of forced vital capacity (FVC) measured after bronchodilation. A negative rate of decline indicates decreasing FVC over time, while a positive value indicates increasing FVC|From day 30 to 4 years|||ml/year||Standard Error|Mean
708941|NCT00144339|Secondary|Pre-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 30 to 4 Years|Rate of decline of forced vital capacity (FVC) measured before the use of bronchodilators. A negative rate of decline indicates decreasing FVC over time, while a positive value indicates increasing FVC|From day 30 to 4 years|||ml/year||Standard Error|Mean
708942|NCT00144339|Secondary|Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment|Rate of decline of forced expiratory volume in one second (FEV1) measured after the use of bronchodilators. A negative rate of decline indicates decreasing FEV1 over time, while a positive value indicates increasing FEV1|Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days|||ml/year||Standard Error|Median
708943|NCT00144339|Secondary|Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment|Rate of decline of forced expiratory volume in one second (FEV1) measured before the use of bronchodilators. A negative rate of decline indicates decreasing FEV1 over time, while a positive value indicates increasing FEV1|Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days.|||ml/year||Standard Error|Median
708944|NCT00144339|Primary|Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years|Rate of decline of forced expiratory volume in one second (FEV1) measured after bronchodilation. A negative rate of decline indicates decreasing FEV1 over time, while a positive value indicates increasing FEV1.|From day 30 to 4 years|||ml/year||Standard Error|Mean
708945|NCT00144339|Primary|Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years|Rate of decline of forced expiratory volume in one second (FEV1) measured before the use of bronchodilators. A negative rate of decline indicates decreasing FEV1 over time, while a positive value indicates increasing FEV1.|From day 30 to 4 years|||ml/year||Standard Error|Mean
708946|NCT00144391|Primary|Fatigue Impact Scale|change in fatigue impact scale there are 42 questions. Each question can be answered from 0 (no problem) to 4 (extreme problem), so a higher score indicates more severe fatigue impact. minimum score=0, maximum score =148 values are calculated at baseline and 6 months and the score at 6 months compared to baseline months is calculated|6 months|||units on a scale||Standard Deviation|Mean
708947|NCT00144781|Secondary|Change From Baseline to Week 26 in Six Minute Walk Test (6MWT)|Six Minute Walk Test: Distance walked (measured in Meters) in 6 minutes. A longer distance indicates a greater response.|Baseline to 26 Weeks|The analysis was intention to treat.||meters||95% Confidence Interval|Mean
708948|NCT00144781|Secondary|Percent Change From Baseline to Week 26 in Liver Organ Volume|A greater decrease in liver volume indicates a greater response.|Baseline to 26 Weeks|The analysis was intention to treat.||Percentage of Change in Liver Volume||95% Confidence Interval|Mean
708949|NCT00144781|Primary|Percent Change From Baseline to Week 26 in Urinary Glycosaminoglycan (GAG) Level|Urinary GAG Level - Concentration of GAG relative to creatinine in urine. A greater decrease in GAG level indicates a greater response.|Baseline to 26 Weeks|Based on the changes in urinary GAG levels observed in the Phase 3 double-blind study, a sample size of 8 patients per group would have sufficient power to detect a 29 percentage point difference between groups in the mean change in urinary GAG levels as being statistically significant. The analysis was intention to treat.||Percentage of Change in GAG Level||95% Confidence Interval|Mean
708950|NCT00144963|Primary|MTD of VSLI|Subjects had to receive at least 1 course consisting of 4 weekly infusions of VSLI at the assigned drug dose with a minimum 2 weeks of observation after the last VSLI dose to be included in the evaluation of the MTD.|6 weeks|This study was designed to define the MTD of VSLI. Up to 7 sequential escalating dose cohorts (1.5, 1.825, 2.0, 2.25, 2.4, 2.6, and 2.8 mg/m2) were planned, with at least 3 subjects in each cohort. Escalation to the next higher dose cohort was allowed to proceed only if no nonhematologic DLT was observed.||mg/m2|||Number
708951|NCT00145041|Primary|Volume of Distribution|The PK profiles of total plasma VCR following a single intravenous infusion at a target dose of 1.0 mg/m2 for approximately 1 hour|cycle 1 day 1|all patients enrolled||mL/m2||Standard Deviation|Mean
708952|NCT00145041|Primary|Clearance|The pharmacokinetic profile of VCR on Day 1 of Cycle 1 Cl is mL/h/m2|Day 1 of Cycle 1|All subjects enrolled||ml/h/m2||Standard Deviation|Mean
708953|NCT00145041|Primary|T 1/2|The PK profiles of total plasma VCR following a single intravenous infusion at a target dose of 1.0 mg/m2 for approximately 1 hour every 2 weeks (one cycle) to three male and four female subjects with malignant melanoma and hepatic dysfunction secondary to metastases were measured.|cycle 1 day 1|all patients enrolled||hr||Standard Deviation|Mean
708954|NCT00145119|Primary|ECG-documented Ventricular Fibrillation or Symptomatic Sustained Ventricular Tachycardia (VT)|ECG-documented ventricular fibrillation or symptomatic sustained ventricular tachycardia (VT)|2 year|||participants|||Number
708955|NCT00145249|Secondary|Mean Change in Neurological Exam Score From Baseline - Day 168|Neurological assessment by Mini-mental Status Exam (MMSE). This is collected as a continuous variable with values from 0-30; where lower scores indicate greater impairment.|Baseline and Day 168|The number of subjects tested in the modified Intent to Treat (mITT) population includes all subjects who are randomized to a treatment arm & receive any dose of study drug, who provide any outcome data, & who are determined to have met 2 key criteria for inclusion in the primary analysis: diagnosis of cryptococcal meningitis & HIV infection.||Scores on a scale||Standard Deviation|Mean
708956|NCT00145249|Secondary|Mean Change in Neurological Exam Score From Baseline - Day 70|Neurological assessment by Mini-mental Status Exam (MMSE). This is collected as a continuous variable with values from 0-30; where lower scores indicate greater impairment.|Baseline and Day 70|The number of subjects tested in the modified Intent to Treat (mITT) population includes all subjects who are randomized to a treatment arm & receive any dose of study drug, who provide any outcome data, & who are determined to have met 2 key criteria for inclusion in the primary analysis: diagnosis of cryptococcal meningitis & HIV infection.||Scores on a scale||Standard Deviation|Mean
708957|NCT00145249|Secondary|Mean Change in Neurological Exam Score From Baseline - Day 42|Neurological assessment by Mini-mental Status Exam (MMSE). This is collected as a continuous variable with values from 0-30; where lower scores indicate greater impairment.|Baseline and Day 42|The number of subjects tested in the modified Intent to Treat (mITT) population includes all subjects who are randomized to a treatment arm & receive any dose of study drug, who provide any outcome data, & who are determined to have met 2 key criteria for inclusion in the primary analysis: diagnosis of cryptococcal meningitis & HIV infection.||Scores on a scale||Standard Deviation|Mean
708958|NCT00145249|Secondary|Mean Change in Neurological Exam Score From Baseline - Day 14|Neurological assessment by Mini-mental Status Exam (MMSE). This is collected as a continuous variable with values from 0-30; where lower scores indicate greater impairment.|Baseline and Day 14|The number of subjects tested in the modified Intent to Treat (mITT) population includes all subjects who are randomized to a treatment arm & receive any dose of study drug, who provide any outcome data, & who are determined to have met 2 key criteria for inclusion in the primary analysis: diagnosis of cryptococcal meningitis & HIV infection.||Scores on a scale||Standard Deviation|Mean
708959|NCT00145249|Secondary|Number of Cryptococcal Isolates With Antifungal Susceptibility|Isolates were collected at days 14 and 70 for assessment of antifungal susceptibility.|Days 14 and 70|The study team has since determined that the assay that was to be utilized did not have sufficient sensitivity/specificity for its intended purpose and therefore these results will not be generated.||Isolates|||Number
708960|NCT00145249|Secondary|Mean Days of Hospitalization|Mean days of hospitalization. Includes days subject was hospitalized prior to study enrollment for current hospital stay.|7, 14, 42, and 70 days|The mITT population includes all subjects who are randomized to a treatment arm and receive any dose of study drug, who provide any outcome data, and who are determined to have met 2 key criteria for inclusion in the primary analysis - diagnosis of culture-proven cryptococcal meningitis and proven HIV infection.||Days||Standard Deviation|Mean
708961|NCT00145249|Secondary|Number of Subjects Reporting Immune Reconstitution Inflammatory Syndrome (IRIS)|"Number of subjects reporting immune reconstitution inflammatory syndrome (IRIS) following treatment.
Day = Day relative to first dose of study drug"|14, 42, and 70 days|The Regulatory Safety population includes all subjects who were randomized, who receive at least 1 dose of study drug, and who have any on-study data||Subjects|||Number
708962|NCT00145249|Secondary|Number of Subjects Meeting the Key Efficacy Endpoint of Treatment Success|Treatment success is defined as a composite of the 3 mycologic and clinical measures: CSF culture conversion; neurologically stable or improved; and alive|14, 42, and 70 days|The mITT population includes all subjects who are randomized to a treatment arm and receive any dose of study drug, who provide any outcome data, and who are determined to have met 2 key criteria for inclusion in the primary analysis - diagnosis of culture-proven cryptococcal meningitis and proven HIV infection.||Subjects|||Number
708963|NCT00145249|Secondary|Number of Subjects With Cerebrospinal Fluid (CSF) Culture Conversion at Multiple Time Points|Number of subjects that have a negative fungal culture at Baseline, Day 14, Day 42, and Day 70.|Baseline, 14, 42, and 70 days|The modified Intent to Treat (mITT) population includes all subjects who are randomized to a treatment arm and receive any dose of study drug, who provide any outcome data, and who are determined to have met 2 key criteria for inclusion in the primary analysis - diagnosis of culture-proven cryptococcal meningitis and proven HIV infection.||Subjects|||Number
708964|NCT00145249|Secondary|Number of Deaths|"Number of deaths occurring on study.
Day = Day relative to the first dose of study drug."|14, 42, and 70 days|The Regulatory Safety Population was used in this analysis, which includes all subjects who were randomized, who received at least 1 dose of study drug, and who have any on-study data.||Subjects|||Number
708965|NCT00145249|Primary|Number of Dose-limiting Toxicities Attributed to Treatment Regimens|"Events are reported by MedDRA Preferred Term.
Dose limiting toxicities include events that resulted in study drug being adjusted, interrupted, or discontinued."|Day 100|The Regulatory Safety population includes all subjects who were randomized, who receive at least 1 dose of study drug, and who have any on-study data.||Events|||Number
708966|NCT00145249|Primary|Number of Grade 3-5 Adverse Experiences That Are Definitely or Probably Related to Study Drug|"Events are reported by MedDRA Preferred Term.
Grade 3 - Severe. Incapacitating; inability to perform usual activities and daily tasks; significantly affects clinical status; requires therapeutic intervention.
Grade 4 - Life-threatening. AE is life-threatening.
Grade 5 - Death. AE causes death."|Day 100|The Regulatory Safety population includes all subjects who were randomized, who receive at least 1 dose of study drug, and who have any on-study data.||Events|||Number
708967|NCT00145327|Secondary|The Number of Participants With Clinically Significant Laboratory Parameters|Evaluate the laboratory key profile such as Calcium, Creatinine and Urea. The number of patients with clinically significant calcium, creatinine and urea were reported.|Extension Baseline (Year 3; Month 36 prior to the first treatment of the extension study) to Year 6|Safety Population included all patients in the ITT population who received at least one dose of study drug during the extension study.||Participants|||Number
708968|NCT00145327|Secondary|Change in Serum Creatinine From Baseline to 9-11 Days Post Year 5 Infusion|Serum creatinine measurements performed by a central laboratory was used to evaluate acute changes in renal function 9-11 days after Year 5 study drug infusion.|Extension Baseline (Year 3; Month 36 prior to the first treatment of the extension study) to 9-11 days after the Year 5 infusion|Safety Population included all patients in the ITT population who received at least one dose of study drug during the extension study.||μmol/L||Standard Deviation|Mean
708969|NCT00145327|Secondary|Change in Serum Creatinine From Baseline to 9-11 Days Post Year 4 Infusion|Serum creatinine measurements performed by a central laboratory was used to evaluate acute changes in renal function 9-11 days after Year 4 study drug infusion.|Extension Baseline (Year 3; Month 36 prior to the first treatment of the extension study) to 9-11 days after the Year 4 infusion|Safety Population included all patients in the ITT population who received at least one dose of study drug during the extension study.||μmol/L||Standard Deviation|Mean
708970|NCT00145327|Secondary|Change in Serum Creatinine From Baseline to 9-11 Days Post Year 3 Infusion|Serum creatinine measurements performed by a central laboratory was used to evaluate acute changes in renal function 9-11 days after study drug infusion in Z6 patients compared to Z3P3 patients and in P3Z3 patients.|Extension Baseline (Year 3; Month 36 prior to the first treatment of the extension study) to 9-11 days after the Year 3 infusion|Safety Population included all patients in the ITT population who received at least one dose of study drug during the extension study.||μmol/L||Standard Deviation|Mean
708971|NCT00145327|Secondary|Qualitative Bone Biopsy Parameters|Unpaired transiliac crest bone biopsy was performed for histomorphometry, which was obtained after double tetracycline labeling. No data were collected for Patients who received Placebo for the first 3 years of the study (Placebo 3 Zoledronic Acid 3).|End of Study Visit at Year 6|Bone Biopsy sub-population.||Participants|||Number
708972|NCT00145327|Secondary|Number of Participants With Incidence of Clinical Fracture|Clinical fracture excludes finger, toe, and facial bone fractures. Clinical vertebral fracture includes thoracic spine fracture and lumbar spine fracture. Non-vertebral fracture excludes clinical vertebral, finger, toe, and facial bone fractures.|Extension Baseline (Year 3; Month 36) to Year 6|Intention to treat (ITT) population included all patients who were randomized or enrolled in the extension study at Visit 8. n = the number of patients with measurements at Year 6 as determined by the analysis window.||Participants|||Number
708973|NCT00145327|Secondary|Percentage of Patients With New and New/Worsening Morphometric Vertebral Fractures|Lateral vertebral x-rays were performed at the final core study visit and at Year 6 and read by a central expert reader at a central imaging laboratory to assess for new or new/worsening morphometric vertebral fracture. The percentage of patients with new morphometric vertebral fractures (observed for the first time) and patients with either new or worsening morphometric vertebral fractures was calculated.|Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6|Intention to treat (ITT) population included all patients who were randomized or enrolled in the extension study at Visit 8. The number of patients analyzed = the number of patients with measurements at Year 6 as determined by the analysis window.||Percentage of patients|||Number
708974|NCT00145327|Secondary|Percentage Change in BMD of Femoral Neck, Total Hip and Trochanter at Year 6 Relative to Year 3|The percentage change in BMD as measured by DXA at Year 6 relative to Year 3. It was derived as 100 * (BMD at Year 6 - BMD at Year 3)/(BMD at Year 3).|Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6 (Month 72)|Intention to treat (ITT) population included all patients who were randomized or enrolled in the extension study at Visit 8. The number of patients analyzed = the number of patients with measurements at Year 6 and Year 3 as determined by the analysis window.||Percentage change in BMD||Standard Error|Mean
708975|NCT00145327|Secondary|Percentage Change in BMD of Femoral Neck, Total Hip and Trochanter at Year 4.5 Relative to Year 3|The percentage change in BMD as measured by DXA at 4.5 relative to Year 3. It was derived as 100 * (BMD at Year 4.5 - BMD at Year 3)/(BMD at Year 3).|Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 4.5 (Month 54)|Intention to treat (ITT) population included all patients who were randomized or enrolled in the extension study at Visit 8. The number of patients analyzed = the number of patients with measurements at Year 4.5 and Year 3 as determined by the analysis window.||Percentage change in BMD||Standard Error|Mean
708976|NCT00145327|Secondary|Percentage Change in BMD of Distal Radius at Year 6 Relative to Year 3|The percentage change in BMD as measured by DXA at Year 6 relative to Year 3. It was derived as 100 * (BMD at Year 6 - BMD at Year 3)/(BMD at Year 3).|Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6 (Month 72)|Intention to treat (ITT) population included all patients who were randomized or enrolled in the extension study at Visit 8. The number of patients analyzed = the number of patients with measurements at Year 6 and Year 3 as determined by the analysis window.||Percentage change in BMD||Standard Error|Mean
708977|NCT00145327|Secondary|Percentage Change in BMD of Distal Radius at Year 4.5 Relative to Year 3|The percentage change in BMD as measured by DXA at Year 4.5 relative to Year 3. It was derived as 100 * (BMD at Year 4.5 - BMD at Year 3)/(BMD at Year 3).|Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 4.5 (Month 54)|Intention to treat (ITT) population included all patients who were randomized or enrolled in the extension study at Visit 8. The number of patients analyzed = the number of patients with measurements at Year 4.5 and Year 3 as determined by the analysis window.||Percentage change in BMD||Standard Error|Mean
708978|NCT00145327|Secondary|Percentage Change in BMD of Lumbar Spine at Year 6 Relative to Year 3|The percentage change in BMD as measured by DXA at Year 6 relative to Year 3. It was derived as 100 * (BMD at Year 6 - BMD at Year 3)/(BMD at Year 3).|Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6|Intention to treat (ITT) population included all patients who were randomized or enrolled in the extension study at Visit 8. The number of patients analyzed = the number of patients with measurements at Year 6 and Year 3 as determined by the analysis window.||Percentage change in BMD||Standard Error|Mean
708979|NCT00145327|Secondary|Percentage Change in BMD of Lumbar Spine at Year 4.5 Relative to Year 3|The percentage change in BMD as measured by DXA at Year 4.5 relative to Year 3. It was derived as 100 * (BMD at Year 4.5 - BMD at Year 3)/(BMD at Year 3).|Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 4.5 (Month 54)|Intention to treat (ITT) population included all patients who were randomized or enrolled in the extension study at Visit 8. The number of patients analyzed = the number of patients with measurements at Year 4.5 and Year 3 as determined by the analysis window.||Percentage Change in BMD||Standard Error|Mean
708980|NCT00145327|Secondary|Bone Resorption and Formation Biochemical Markers at Year 6: P1NP|The amount of serum P1NP as determined by the central laboratory|Year 6|Intention to treat (ITT) population included all patients who were randomized or enrolled in the extension study at Visit 8. The Number of patients analyzed = the number of patients with measurements in Year 6 as determined by the analysis window.||ng/mL||Standard Error|Mean
708981|NCT00145327|Secondary|Bone Resorption and Formation Biochemical Markers at Year 4.5: P1NP|The amount of serum n-terminal propeptide of type I collagen (P1NP) as determined by the central laboratory.|Year 4.5|Intention to treat (ITT) population included all patients who were randomized or enrolled in the extension study at Visit 8. The number of patients analyzed = the number of patients with measurements at Year 4.5 as determined by the analysis window.||ng/mL||Standard Error|Mean
708982|NCT00145327|Primary|Percentage Change in Bone Mineral Density (BMD) of Femoral Neck at Year 6 Relative to Year 3|The primary efficacy variable was the percentage change in BMD of the femoral neck as measured by dual x-ray absorptiometry (DXA) at Year 6 relative to Year 3. It was derived as 100 *(femoral neck BMD at Year 6 − femoral neck BMD at Year 3) / (femoral neck BMD at Year 3).|Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6 (Month 72; end of extension study)|Modified intent-to-treat (MITT) population. The MITT population included all patients in the ITT population who had DXA measurements of the femoral neck at Year 3 and Year 6. This was the primary population for primary efficacy parameter.||Percentage Change in BMD||Standard Error|Mean
708983|NCT00145418|Secondary|Safety Objective is to Describe the Safety Profile of 1st Line Treatment by Recording Grade 3 and 4 Adverse Events Experienced by Participants in This Trial.|Toxicities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE V 3.0) and the incidence of any Grade 3 or 4 toxicities will be analyzed. Toxicity is assessed every cycle.|day one of cycle one until participant removed from trial|all participants had adverse events||participants|||Number
708984|NCT00145418|Secondary|Duration of Response|Duration of response is a measure of how long the participants response to therapy was maintained.|0 -12 months|||months||Full Range|Median
708985|NCT00145418|Secondary|Time to Progression|Progression is measured from each participants start of study until removal from treatment.|<1 cycle to 6 cycles of treatment|||months||Full Range|Median
708986|NCT00145418|Primary|Response Rate|Response rate by RECIST criteria to the combination of oxaliplatin and docetaxel in patients with previously untreated NSCLC. Per RECIST 1.0 defines a complete response (CR)as the disappearance of all disease. A partial response(PR) as a minimum of a 30% decrease in the sum of the longest dimension of target lesions. Progressive disease (PR) is defined as a minimum of a 20% increase in the sum of the longest dimension of target lesions. Stable disease is defined as neither sufficient shrinkage to qualify as a PR nor sufficient increase to qualify as PD.|Response is measured every 2 cycles until disease progression|||Participants|||Number
708987|NCT00134381|Secondary|Effect of 4-6% Caffeine on UVB-Induced Erythema|Erythema of the right and left test sites was scored on a scale of 0-3 (0 = no evidence [no erythema]; 1 = mild [pink or light red color]; 2 = moderate [red color]; 3 = severe [very red or dark color]) including half-integer grading. Scoring was performed immediately after UVB exposure and at sequential time points thereafter. The erythema scores at 6, 8, and 24 hr post-UVB were averaged.|24 hr|Sixty-two (62) subjects received caffeine on one test site and placebo on the other site after exposure to 0.5-1.5 times individual subjects' minimal erythema dose (MED) of UVB.||units on a scale||Standard Error|Mean
708988|NCT00134381|Secondary|Effect of Green Tea Compounds on UVB-Induced Erythema|Erythema of the right and left test sites was scored on a scale of 0-3 (0 = no evidence [no erythema]; 1 = mild [pink or light red color]; 2 = moderate [red color]; 3 = severe [very red or dark color]) including half-integer grading. Scoring was performed immediately after UVB exposure and at sequential time points thereafter. The mean scores at 48 hr were calculated.|48 hrs|Six (6) subjects were randomized (split-body) to receive either EGCG (3 subjects) or caffeine (3 subjects) in acetone vehicle on a test site on one side of the body and placebo (acetone vehicle) on the test site on the other side of the body, after exposure to twice the individual subjects' minimal erythema dose (MED) of UVB.||units on a scale||Standard Error|Mean
708989|NCT00134381|Primary|Effect of Topical Applications of 4-6% Caffeine on UVB-Induced Increases in Phospho-p53 (Ser15) Positive Cells|The percentage of phospho-p53 (Ser15) positive cells was identified in the 48-hr time point skin biopsy samples of subjects who had been exposed to UVB on symmetrical right and left test sites which were then randomized to receive 4-6% caffeine in cream vehicle or placebo (cream vehicle) at sequential time points after UVB exposure.|48 hr|Twenty (20) subjects received caffeine on one test site and placebo on the other site after exposure to individual subjects' minimal erythema dose (MED) of UVB.Twenty-six (26) subjects received caffeine on one test site and placebo on the other site after exposure to UVB that was 1.5 times subjects' individual minimal erythema dose (MED).||percentage of p-p53 (Ser15) pos. cells||Standard Error|Mean
708990|NCT00134381|Primary|Effect of Topical Applications of 4-6% Caffeine on UVB-Induced Increases in Caspase-3-Positive Cells|The percentage of caspase-3-positive cells was identified in the 48-hr time point skin biopsy samples of subjects who had been exposed to UVB on symmetrical right and left test sites which were then randomized to receive 4-6% caffeine in cream vehicle or placebo (cream vehicle) at sequential time points after UVB exposure.|48 hr|Twenty (20) subjects received caffeine on one test site and placebo on the other site after exposure to individual subjects' minimal erythema dose (MED) of UVB.Twenty-six (26) subjects received caffeine on one test site and placebo on the other site after exposure to UVB that was 1.5 times subjects' individual minimal erythema dose (MED).||percentage of caspase-3-positive cells||Standard Error|Mean
708991|NCT00134381|Primary|"Effect of Topical Applications of 4-6% Caffeine on UVB-Induced Increases in Apoptotic Sunburn Cells"|"The percentage of apoptotic sunburn cells was identified in the 48-hr time point skin biopsy samples of subjects who had been exposed to UVB on symmetrical right and left test sites which were then randomized to receive 4-6% caffeine in cream vehicle or placebo (cream vehicle) at sequential time points after UVB exposure."|48 hr|Twenty (20) subjects received caffeine on one test site and placebo on the other site after exposure to individual subjects' minimal erythema dose (MED) of UVB.Twenty-six (26) subjects received caffeine on one test site and placebo on the other site after exposure to UVB that was 1.5 times subjects' individual minimal erythema dose (MED).||"percentage of sunburn cells"||Standard Error|Mean
708992|NCT00134381|Primary|"Change in UVB-Induced Apoptotic Sunburn Cells by Green Tea Compounds"|"The mean change in number of apoptotic sunburn cells between 0- and 48-hour time points was calculated for skin biopsy samples of subjects who had been exposed to UVB on symmetrical right and left test sites which were then randomized to receive active test substance (EGCG or caffeine) or placebo (vehicle) at sequential time points after UVB exposure."|48 hr|Six (6) subjects were randomized (split-body) to receive either EGCG (3 subjects) or caffeine (3 subjects) in acetone vehicle on a test site on one side of the body and placebo (acetone vehicle) on the test site on the other side of the body, after exposure to twice the individual subjects' minimal erythema dose (MED) of UVB.||cells/mm||Standard Error|Mean
708993|NCT00134381|Primary|Change in UVB-Induced Active Caspase-3-Positive Keratinocytes by Green Tea Compounds|The mean change in number of active caspase-3+ apoptotic keratinocytes between 0- and 48-hour time points was calculated for skin biopsy samples of subjects who had been exposed to UVB on symmetrical right and left test sites which were then randomized to receive active test substance (EGCG or caffeine) or placebo (vehicle) at sequential time points after UVB exposure.|48 hrs|Six (6) subjects were randomized (split-body) to receive either EGCG (3 subjects) or caffeine (3 subjects) in acetone vehicle on a test site on one side of the body and placebo (acetone vehicle) on the test site on the other side of the body, after exposure to twice the individual subjects' minimal erythema dose (MED) of UVB.||cells/mm||Standard Error|Mean
708994|NCT00134563|Secondary|Changes From Baseline in Fatigue Impact Scale [FIS] Total Score|"FIS is a subject-reported scale that qualifies the impact of fatigue on daily life in patients with MS. It consists of 40 statements that measure fatigue in three areas; physical, cognitive, and social.
FIS total score ranges from 0 (no problem) to 160 (extreme problem).
Least-square means were estimated using a Mixed-effect model with repeated measures [MMRM] on FIS total score data (treatment group, region of enrollment, baseline EDSS stratum, visit, treatment-by-visit interaction, baseline value, and baseline-by-visit interaction as factors)."|baseline (before randomization) and 108 weeks|All randomized and treated participants; Participants were included in the treatment group to which they were originally assigned (intent-to-treat analysis).||units on a scale||Standard Error|Least Squares Mean
708995|NCT00134563|Other Pre-specified|Cerebral MRI Assessment: Volume of Gd-enhancing T1-lesions Per Scan|Total volume of Gd-enhancing T1-lesions per scan is obtained from the sum of the volumes of Gd-enhancing T1-lesions observed during the study divided by the total number of scans performed during the study.|108 weeks|All randomized and treated participants; Participants were included in the treatment group to which they were originally assigned (intent-to-treat analysis).||mililiters (mL)||Standard Deviation|Mean
708996|NCT00134563|Other Pre-specified|Cerebral MRI Assessment: Number of Gd-enhancing T1-lesions Per Scan (Poisson Regression Estimates)|"Number of Gd-enhancing T1-lesions per scan is obtained from the total number of Gd-enhancing T1-lesions observed during the study divided by the total number of scans performed during the study.
To account for the different number of scans among participants, a Poisson regression model with robust error variance was used (total number of Gd-enhancing T1-lesions as response variable; log-transformed number of scans as offset variable; treatment group, region of enrollment, baseline EDSS stratum and baseline number of Gd-enhancing T1-lesions as covariates)."|108 weeks|All randomized and treated participants; Participants were included in the treatment group to which they were originally assigned (intent-to-treat analysis).||lesions per scan||95% Confidence Interval|Number
709052|NCT00135330|Secondary|Change in Waist-to-hip Ratio|Change in waist-to-hip ratio (waist circumference divided by hip circumference) from baseline to week 20|20 weeks|All Patients Who Have Both Baseline and At Least One Post Baseline Value in Full Analysis Set||ratio (cm/cm)||Standard Error|Least Squares Mean
708997|NCT00134563|Secondary|Cerebral Magnetic Resonance Imaging [MRI] Assessment: Change From Baseline in Total Lesion Volume (Burden of Disease)|Total lesion volume is the sum of the total volume of all T2-lesions and the total volume all T1-hypointense post-gadolinium lesions measured through T2/proton density scan analysis and gadolinium-enhanced T1 scan analysis.|baseline (before randomization) and 108 weeks|All randomized and treated participants; Participants were included in the treatment group to which they were originally assigned (intent-to-treat analysis).||mililiters (mL)||Standard Deviation|Mean
708998|NCT00134563|Secondary|Time to 12-week Sustained Disability Progression: Kaplan-Meier Estimates of the Rate of Disability Progression at Timepoints|"12-week sustained disability progression was defined as an increase from baseline of at least 1-point in EDSS score (at least 0.5-point for participants with baseline EDSS score >5.5) that persisted for at least 12 weeks.
Probability of disability progression at 24, 48 and 108 weeks was estimated using Kaplan-Meier method on the time to disability progression defined as the time from randomization to first EDSS increase. Participants free of disability progression (no disability progression observed on treatment) were censored at the date of the last on-treatment EDSS evaluation.
Kaplan-Meier method consists in computing probabilities of non occurrence of event at any observed time of event and multiplying successive probabilities for time ≤t by any earlier computed probabilities to estimate the probability of being event-free for the amount of time t. Probability of event at time t is 1 minus the probability of being event-free for the amount of time t."|108 weeks|All randomized and treated participants; Participants were included in the treatment group to which they were originally assigned (intent-to-treat analysis).||percent probability||95% Confidence Interval|Number
708999|NCT00134563|Primary|Annualized Relapse Rate [ARR]: Poisson Regression Estimates|"ARR is obtained from the total number of confirmed relapses that occured during the treatment period divided by the sum of the treatment durations.
Each episode of relapse - appearance, or worsening of a clinical symptom that was stable for at least 30 days, that persisted for a minimum of 24 hours in the absence of fever - was to be confirmed by an increase in EDSS score or Functional System scores.
To account for the different treatment durations among participants, a Poisson regression model with robust error variance was used (total number of confirmed relapses as response variable; log-transformed treatment duration as offset variable; treatment group, region of enrollment and baseline EDSS stratum as covariates)."|108 weeks|All randomized and treated participants; Participants were included in the treatment group to which they were originally assigned (intent-to-treat analysis).||relapses per year||95% Confidence Interval|Number
709000|NCT00134719|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Fourth Dose Vaccination Phase|SAEs: medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. NOCI: e.g. autoimmune disorders, asthma, type I diabetes and allergies. Types of rash: hives, idiopathic thrombocytopenic purpura and petechiae. ER and PO visits assessed were not related to well-child care, vaccination, injury or common acute illnesses such as upper respiratory tract infection, otitis media, pharyngitis and gastroenteritis.|From the day of administration of the fourth dose until the end of the extended safety follow-up period (last study contact at 18-21 months of age|Analysis was performed on the Fourth Dose Total Vaccinated Cohort, including all subjects vaccinated during the ourth dose vaccination phase.||Subjects|||Number
709001|NCT00134719|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Primary Vaccination Phase|SAEs: medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. NOCI: e.g. autoimmune disorders, asthma, type I diabetes and allergies. Types of rash: hives, idiopathic thrombocytopenic purpura and petechiae. ER and PO visits assessed were not related to well-child care, vaccination, injury or common acute illnesses such as upper respiratory tract infection, otitis media, pharyngitis and gastroenteritis.|From enrolment through the day preceding the fourth dose|Analysis was performed on the Primary Total Vaccinated Cohort, including all subjects vaccinated during the primary vaccination phase.||Subjects|||Number
709002|NCT00134719|Secondary|Number of Subjects Reporting Specific Solicited General AEs Related to Measles, Mumps, Rubella Vaccine and Varicella Vaccine|Specific solicited general symptoms assessed include fever (temperature greater than or equal to 38 degrees Celcius), meningismus/ febrile convulsion, parotid / salivary gland swelling and rash.|During a 43-day (Day 0-42) after the fourth dose|Analysis was performed on the Primary Total Vaccinated Cohort and the Fourth Dose Total Vaccinated Cohort, including all subjects vaccinated during the primary and fourth dose vaccination phases, respectively.||Subjects|||Number
709003|NCT00134719|Secondary|Number of Subjects Reporting Unsolicited Adverse Events|Unsolicited adverse event covers any adverse event reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31-day (Day 0-30) post-primary and post-fourth dose vaccination period|Analysis was performed on the Primary Total Vaccinated Cohort and the Fourth Dose Total Vaccinated Cohort, including all subjects vaccinated during the primary and fourth dose vaccination phases, respectively.||Subjects|||Number
709004|NCT00134719|Secondary|Number of Subjects Reporting Solicited Local and General Symptoms During the Fourth Dose Vaccination Phase|Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include drowsiness, fever (rectal temperature greater than or equal to 38 degrees Celcius), irritability and loss of appetite.|During a 4-day period (Day 0-3) after the fourth dose vaccination phase|Analysis was performed on all subjects with an available symptom sheet in the Fourth Dose Total Vaccinated Cohort, including all subjects vaccinated during the fourth dose vaccination phase.||Subjects|||Number
709005|NCT00134719|Secondary|Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Phase|Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include drowsiness, fever (rectal temperature greater than or equal to 38 degrees Celcius), irritability and loss of appetite.|During a 4-day period (Day 0-3) after any vaccine dose in the primary vaccination phase|Analysis was performed on all subjects with an available symptom sheet in the Primary Total Vaccinated Cohort, including all subjects vaccinated during the primary vaccination phase.||Subjects|||Number
709006|NCT00134719|Secondary|Anti-varicella Titers in Initially Seronegative Subjects|Titers are presented as Geometric Mean Titers. Initially seronegative subjects are defined as subjects with pre-vaccination anti-varicella titer below 1:5.|42 days after the fourth dose|Analysis was performed on initially seronegative subjects in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.||Titer||95% Confidence Interval|Geometric Mean
709007|NCT00134719|Secondary|Number of Subjects With Anti-varicella Titer Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects|The pre-defined cut-off values were 1:5 and 1:40. Initially seronegative subjects are defined as subjects with pre-vaccination anti-varicella titer below 1:5.|42 days after the fourth dose|Analysis was performed on initially seronegative subjects in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.||Subjects|||Number
709008|NCT00134719|Secondary|Anti-mumps Titers in Initially Seronegative Subjects|Titers are presented as Geometric Mean Titers expressed as ED50, the reciprocal of the sample dilution in the neutralising assay reducing the number of viral plaques by fifty percent. Initially seronegative subjects are defined as subjects with pre-vaccination anti-mumps titer below 24 ED50.|42 days after the fourth dose|Analysis was performed on initially seronegative subjects in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.||Titer||95% Confidence Interval|Geometric Mean
709009|NCT00134719|Secondary|Number of Subjects With Anti-mumps Titer Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects|The pre-defined cut-off values were 28 ED50 and 51 ED50. Initially seronegative subjects are defined as subjects with pre-vaccination anti-mumps titer below 24 ED50.|42 days after the fourth dose|Analysis was performed on initially seronegative subjects in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.||Subjects|||Number
709010|NCT00134719|Secondary|Number of Subjects With Anti-mumps Titer Greater Than or Equal to 28 ED50 in Subjects With Anti-mumps Titer Below 28 ED50 Before Vaccination|ED50 is defined as the reciprocal of the sample dilution in the neutralising assay reducing the number of viral plaques by fifty percent.|42 days after the fourth dose|Analysis was performed on subjects with a pre-vaccination anti-mumps titer below 28 ED50 in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.||Subjects|||Number
709011|NCT00134719|Secondary|Anti-rubella Concentrations in Initially Seronegative Subjects|Concentrations are presented as Geometric Mean Concentrations expressed as IU/mL. Initially seronegative subjects are defined as subjects with pre-vaccination anti-rubella concentration below 4 IU/mL.|42 days after the fourth dose|Analysis was performed on initially seronegative subjects in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.||International Units per Milliliter||95% Confidence Interval|Geometric Mean
709012|NCT00134719|Secondary|Number of Subjects With Anti-rubella Concentration Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects|The pre-defined cut-off values were 4 IU/mL and 10 IU/mL. Initially seronegative subjects are defined as subjects with pre-vaccination anti-measles concentration below 4 IU/mL.|42 days after the fourth dose|Analysis was performed on initially seronegative subjects in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.||Subjects|||Number
709013|NCT00134719|Secondary|Anti-measles Concentrations in Initially Seronegative Subjects|Concentrations are presented as Geometric Mean Concentrations expressed as mIU/mL. Initially seronegative subjects are defined as subjects with pre-vaccination anti-measles concentration below 150 mIU/mL.|42 days after the fourth dose|Analysis was performed on initially seronegative subjects in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.||Milli-International Units per Milliliter||95% Confidence Interval|Geometric Mean
709014|NCT00134719|Secondary|Number of Subjects With Anti-measles Concentration Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects|The pre-defined cut-off values were 150 mIU/mL and 200 mIU/mL. Initially seronegative subjects are defined as subjects with pre-vaccination anti-measles concentration below 150 mIU/mL.|42 days after the fourth dose|Analysis was performed on initially seronegative subjects in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.||Subjects|||Number
709015|NCT00134719|Secondary|Number of Subjects With a Fourth Dose Response for hSBA-MenY|Fourth dose response for hSBA-MenY defined as: •For initially seronegative subjects (i.e., pre fourth dose hSBA antibody titer < 1:4), post fourth dose hSBA antibody titer greater than or equal to (≥) 1:16; •For initially seropositive subjects with pre fourth dose hSBA antibody titer ≥ 1:4 and < 1:64, post fourth dose hSBA antibody titer at least 4-fold higher than the pre fourth dose hSBA antibody titer; •For initially seropositive subjects with pre fourth dose hSBA antibody titer ≥ 1:64, post fourth dose hSBA antibody titer at least 2-fold higher than the pre fourth dose hSBA antibody titer.|42 days after the fourth dose|Analysis was performed on the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.||Subjects|||Number
709016|NCT00134719|Secondary|Number of Subjects With a Fourth Dose Response for hSBA-MenC|Fourth dose response for hSBA-MenC is defined as: •For initially seronegative subjects (i.e., subjects with pre fourth dose hSBA antibody titer below 1:4), post fourth dose hSBA antibody titer greater than or equal to 1:16; •For initially seropositive subjects (i.e., subjects with pre fourth dose antibody titer greater than or equal to 1:4), post fourth dose hSBA antibody titer greater than or equal to 1:128.|42 days after the fourth dose|Analysis was performed on the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.||Subjects|||Number
709017|NCT00134719|Secondary|Number of Subjects With Anti-varicella Titer Greater Than or Equal to 1:5|The cut-off value assessed was a titer of 1:5.|Just prior to the fourth dose and 42 days after the fourth dose|Analysis was performed on the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point||Subjects|||Number
709053|NCT00135330|Secondary|Change in Hip Circumference|Change in hip circumference form baseline to week 20|20 weeks|All Patients Who Have Both Baseline and At Least One Post Baseline Value in Full Analysis Set||cm||Standard Error|Least Squares Mean
709018|NCT00134719|Secondary|Number of Subjects With Anti-rubella Concentration Greater Than or Equal to 4 IU/mL|The cut-off value assessed was 4 IU/mL.|Just prior to the fourth dose and 42 days after the fourth dose|Analysis was performed on the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.||Subjects|||Number
709019|NCT00134719|Secondary|Number of Subjects With Anti-mumps Titer Greater Than or Equal to 24 ED50|ED50 is defined as the reciprocal of the sample dilution in the neutralising assay reducing the number of viral plaques by fifty percent.|Just prior to the fourth dose and 42 days after the fourth dose|Analysis was performed on the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.||Subjects|||Number
709020|NCT00134719|Secondary|Number of Subjects With Anti-measles Concentration Greater Than or Equal to 150 mIU/mL|The cut-off value assessed was 150 mIU/mL.|Just prior to the fourth dose and 42 days after the fourth dose|Analysis was performed on the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.||Subjects|||Number
709021|NCT00134719|Secondary|Anti-PRP Concentrations|The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. Concentrations are given as Geometric Mean Concentrations.|After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)|Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.||Microgram per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
709022|NCT00134719|Secondary|Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values|The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. The cut-off values assessed were 0.15 µg/mL and 1.0 µg/mL.|After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)|Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.||Subjects|||Number
709023|NCT00134719|Secondary|Anti-PSY Concentrations|The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. Concentrations are given as Geometric Mean Concentrations.|After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)|Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.||Microgram per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
709024|NCT00134719|Secondary|Number of Subjects With Anti-Polysaccharide Y (Anti-PSY) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values|The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. The cut-off values assessed were 0.3 µg/mL and 2 µg/mL.|After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)|Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.||Subjects|||Number
709025|NCT00134719|Secondary|Anti-PSC Concentrations|The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. Concentrations are given as Geometric Mean Concentrations.|After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)|Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.||Microgram per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
709026|NCT00134719|Secondary|Number of Subjects With Anti-Polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values|The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. The cut-off values assessed were 0.3 µg/mL and 2 µg/mL.|After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)|Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.||Subjects|||Number
709027|NCT00134719|Secondary|hSBA-MenY Titers|The analysis for was performed on the first 30% of the blood samples taken at each time point. Titers are given as Geometric Mean Titers.|After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)|Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.||Titer||95% Confidence Interval|Geometric Mean
709054|NCT00135330|Secondary|Change in Waist Circumference|Change in waist circumference from baseline to week 20|20 weeks|All Patients Who Have Both Baseline and At Least One Post Baseline Value in Full Analysis Set||cm||Standard Error|Least Squares Mean
709055|NCT00135330|Secondary|Change in Lean Body Mass During a Meal Challenge Test (MCT)|Change in lean body mass from baseline to week 20, as assessed during an MCT|20 weeks|All Patients in Full Analysis Set Who Have Both Baseline and Endpoint Measurements||kg||Standard Error|Least Squares Mean
709028|NCT00134719|Secondary|Number of Subjects With Meningococcal Polysaccharide Y Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenY) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values|The analysis for was performed on the first 30% of the blood samples taken at each time point. The cut-off values assessed were titers 1:4 and 1:8.|After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)|Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.||Subjects|||Number
709029|NCT00134719|Secondary|hSBA-MenC Titers|The analysis for was performed on the first 30% of the blood samples taken at each time point. Titers are given as Geometric Mean Titers.|After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)|Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.||Titer||95% Confidence Interval|Geometric Mean
709030|NCT00134719|Secondary|Number of Subjects With Meningococcal Polysaccharide C Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenC) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values|The analysis for was performed on the first 30% of the blood samples taken at each time point. The cut-off values assessed were titers 1:4 and 1:8.|After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)|Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.||Subjects|||Number
709031|NCT00134719|Secondary|rSBA-MenY Titers|The analyses for post-Dose 2 and post-Dose 3 data were performed on blood samples taken from the respective half of the subjects at both time points. Titers are given as Geometric Mean Titers.|After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)|Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.||Titer||95% Confidence Interval|Geometric Mean
709032|NCT00134719|Secondary|Number of Subjects With rSBA-MenY Titer Greater Than or Equal to Pre-defined Cut-off Values|The analyses for post-Dose 2 and post-Dose 3 data were performed on blood samples taken from the respective half of the subjects at both time points. The cut-off values assessed were titers 1:8 and 1:128.|After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)|Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.||Subjects|||Number
709033|NCT00134719|Secondary|rSBA-MenC Titers|The analyses for post-Dose 2 and post-Dose 3 data were performed on blood samples taken from the respective half of the subjects at both time points. Titers are given as Geometric Mean Titers.|After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)|Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.||titer||95% Confidence Interval|Geometric Mean
709034|NCT00134719|Secondary|Number of Subjects With rSBA-MenC Titer Greater Than or Equal to Pre-defined Cut-off Values|The analyses for post-Dose 2 and post-Dose 3 data were performed on blood samples taken from the respective half of the subjects at both time points. The cut-off values assessed were titers 1:8 and 1:128.|After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)|Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.||Subjects|||Number
709035|NCT00134719|Primary|Number of Subjects Seroconverted for Anti-varicella Antibodies|The analysis was performed on blood samples taken from the subjects in the MenHibrix and ActHIB groups only. Anti-varicella seroconversion is defined as post-vaccination titers greater than or equal to 1:5, in subjects seronegative (titers below 1:5) before vaccination.|42 days after the fourth dose vaccination|Analysis was performed on initially seronegative subjects in the MenHibrix and ActHIB groups only, on the Fourth dose According-to-Protocol cohort for immunogenicity, including all evaluable subjects with assay result available for the blood sample taken at 42 days after the administration of the fourth vaccine dose.||Subjects|||Number
709036|NCT00134719|Primary|Number of Subjects With an Anti-rubella Seroresponse|The analysis was performed on blood samples taken from the subjects in the MenHibrix and ActHIB groups only. Anti-rubella seroresponse is defined as post-vaccination concentration greater than or equal to 10 IU/mL (ELISA, Enzygnost) in subjects seronegative (concentration below 4 IU/mL) before vaccination.|42 days after the fourth dose vaccination|Analysis was performed on initially seronegative subjects in the MenHibrix and ActHIB groups only, on the Fourth dose According-to-Protocol cohort for immunogenicity, including all evaluable subjects with assay result available for the blood sample taken at 42 days after the administration of the fourth vaccine dose.||Subjects|||Number
709056|NCT00135330|Secondary|Change in Body Fat Mass During a Meal Challenge Test (MCT)|Change in body fat mass form baseline to week 20, as assessed during an MCT|20 weeks|All Patients in Full Analysis Set Who Have Both Baseline and Endpoint Measurements||kg||Standard Error|Least Squares Mean
709037|NCT00134719|Primary|Number of Subjects Seroconverted for Anti-mumps Antibodies|"The analysis was performed on blood samples taken from the subjects in the MenHibrix and ActHIB groups only. Anti-mumps seroconversion is defined as titer greater than or equal to 28 ED50 in subjects seronegative (<28 ED50) before vaccination.
ED50 is defined as the reciprocal of the sample dilution in the neutralising assay reducing the number of viral plaques by fifty percent."|42 days after the fourth dose vaccination|Analysis was performed on initially seronegative subjects in the MenHibrix and ActHIB groups only, on the Fourth dose According-to-Protocol cohort for immunogenicity, including all evaluable subjects with assay result available for the blood sample taken at 42 days after the administration of the fourth vaccine dose.||Subjects|||Number
709038|NCT00134719|Primary|Number of Subjects Seroconverted for Anti-measles Antibodies|The analysis was performed on blood samples taken from the subjects in the MenHibrix and ActHIB groups only. Anti-measles seroconversion is defined as the appearance of antibodies (i.e. concentration greater than or equal to the cut-off value of 150 milli-international units per milliliter (mIU/mL)) in the serum of subjects seronegative (below 150 mIU/mL) before vaccination.|42 days after the fourth dose vaccination|Analysis was performed on initially seronegative subjects in the MenHibrix and ActHIB groups only, on the Fourth dose According-to-Protocol cohort for immunogenicity, including all evaluable subjects with assay result available for the blood sample taken at 42 days after the administration of the fourth vaccine dose.||Subjects|||Number
709039|NCT00134719|Primary|Number of Subjects With Meningococcal Polysaccharide C Serum Bactericidal Activity/Assay Using Baby Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to 1:128|The analysis was performed on blood samples taken from half of the subjects in the MenHibrix and ActHIB + Meningitec groups only. The other half of the subjects in these study groups donated a blood sample after the second vaccine dose for analysis of the corresponding secondary outcome measure.|One month after the 3-dose primary vaccination course|Analysis was performed on subjects in the MenHibrix and ActHIB + Meningitec groups only, on the Primary According-to-Protocol Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.||Subjects|||Number
709040|NCT00134719|Primary|Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Concentration Greater Than or Equal to 1.0 Microgram Per Milliliter (µg/mL)|The analysis was performed on blood samples taken from half of the subjects in the MenHibrix and ActHIB/PedvaxHib groups only. The other half of the subjects in these study groups donated a blood sample after the second vaccine dose for analysis of the corresponding secondary outcome measure.|One month after the 3-dose primary vaccination course|Analysis was performed on half of the subjects in the MenHibrix and ActHIB/PedvaxHib groups only, on the Primary According-to-Protocol (ATP) Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.||Subjects|||Number
709041|NCT00134784|Primary|Change in the Ratio of the Specific Striatal [123I]B-CIT Uptake to the Nondisplaceable Striatal [123I]B-CIT Uptake Between the Two Images|The use of SPECT to measure striatal dopamine-transporter density with the use of [123I]B-CIT. Subjects underwent SPECT imaging just before the baseline visit and then again before the visit at week 40.|40 weeks|Per protocol||percent change of B-CIT Uptake|Participants|Standard Deviation|Mean
709042|NCT00134901|Primary|Weekly Cocaine Use|Mean number of cocaine using days per week based on self reported use verified by cocaine toxicology results.|weekly use during length of study participation|||days||Standard Deviation|Mean
709043|NCT00134901|Secondary|Cocaine Abstinence Based on Daily Self Reported Cocaine Use|A binary indicator of sustained abstinence, defined as three consecutive weeks of no cocaine use, obtained by self-report and verified using negative urine toxicology results, at any point of the trial;|reported weekly cocaine use for 12 weeks/ or study participation|All analyses were performed on an intent-to-treat basis||participants|||Number
709044|NCT00135200|Secondary|Time to Treatment Failure||3-6 months||||||
709045|NCT00135200|Secondary|Progression Free Survival Time||3-6 months||||||
709046|NCT00135200|Secondary|Duration of Response||3-6 months||||||
709047|NCT00135200|Secondary|Number of Participants With Complete Response (CR)|"Determine the rate of conversion to complete response (CR). CR requires all of the following:
Absence of the original monoclonal protein in serum and urine on at least 2 determinations by immunofixation. The presence of oligoclonal bands consistent with oligoclonal immune reconstitution does not exclude CR.
Less than 5% plasma cells in the bone marrow on at least 2 determinations. Repeat bone marrow is not required for patients with secretory myeloma who have sustained absence of monoclonal protein on immunofixation.
No increase in size or number of lytic bone lesions (development of a compression fracture does not exclude response).
Disappearance of all soft tissue plasmacytomas.
Patients in whom some, but not all the criteria for CR are fulfilled are classified as nCR or PR or VGPR (see below), providing the remaining criteria for nCR, VGPR, or PR are satisfied."|6 months|||participants|||Number
709048|NCT00135200|Primary|Percentage of Patients With an Objective Response|"The primary objective is to determine of the rate of objective response (percentage of patients with an objective response) defined as sustained reduction of monoclonal proteins by more than 25% versus pre-Bexxar level.
An objective response may be:
Minimal Response (MR) - 25-49% reduction on the level of the serum monoclonal protein for at least 2 determinations.
Partial Response (PR) - 50-89% reduction in the level of the serum monoclonal protein for at least 2 determinations.
Complete Response (CR) - Absence of the original monoclonal protein in serum and urine on at least 2 determinations by immunofixation."|3 months|||percentage of patients||95% Confidence Interval|Number
709049|NCT00135330|Secondary|Pedal Edema Score|"Pedal edema scores experienced by each patient throughout the study (1+ indicates a patient experienced a pedal edema score of 1 , 2, or 3; 2+ indicates a patient experienced a pedal edema score of 2 or 3, etc.)
Scale:
Slight pitting, no visible distortion, disappears rapidly
A somewhat deeper pit than in 1+, but again no readily detectable distortion, and it disappears in 10 – 15 seconds
The pit is noticeably deep and may last more than a minute; the dependent extremity looks fuller and swollen
The pit is very deep, lasts as long as 2 – 5 minutes, and the dependent extremity is grossly distorted"|20 weeks|Full Analysis Set||participants|||Number
709050|NCT00135330|Secondary|Hypoglycemia Rate Per 30 Days Per Patient|Average number of episodes of hypoglycemia per 30 days per patient|20 weeks|Full Analysis Set||hypoglycemia events / 30 days / patient||Standard Deviation|Mean
709051|NCT00135330|Secondary|Incidence of Hypoglycemia Events|Number of subjects experiencing hypoglycemia at any point during the study|20 weeks|Full Analysis Set||participants|||Number
709057|NCT00135330|Secondary|Change in Percent Body Fat During a Meal Challenge Test (MCT)|Change in percent body fat from baseline to week 20, as assessed during an MCT|20 weeks|All Patients in Full Analysis Set Who Have Both Baseline and Endpoint Measurement||percentage||Standard Error|Least Squares Mean
709058|NCT00135330|Secondary|Change in Fasting Triglycerides|Ratio (endpint value divided by baseline value) of fasting triglycerides from baseline to week 20.|Week 20|All patients who have both baseline and at least one post baseline value in full analysis set||mmol/L||Standard Error|Geometric Mean
709059|NCT00135330|Secondary|Change in Fasting LDL Cholesterol|Change in fasting low-density lipoprotein (LDL) cholesterol from baseline to week 20.|Week 20|All patients who have both baseline and at least one post baseline value in full analysis set.||mmol/L||Standard Error|Least Squares Mean
709060|NCT00135330|Secondary|Change in Fasting HDL Cholesterol|Change in fasting high-density lipoprotein (HDL) cholesterol from baseline to week 20.|Week 20|All patients who have both baseline and at least one post baseline value in full analysis set.||mmol/L||Standard Error|Least Squares Mean
709061|NCT00135330|Secondary|Change in Fasting Total Cholesterol.|Change in fasting total cholestrol from baseline to week 20.|Week 20|All patients who have both baseline and at least one post baseline value in full analysis set.||mmol/L||Standard Error|Least Squares Mean
709062|NCT00135330|Secondary|Change in Body Weight|Change in body weight from baseline to week 20.|Week 20|All patients who aave both baseline and at least one post baseline value in full analysis set.||kg||Standard Error|Least Squares Mean
709063|NCT00135330|Secondary|Change in Fasting Proinsulin|Ratio (endpoint value divided by baseline value) for fasting proinsulin, comparing endpoint (week 20) to baseline|Week 20|All patients who have both baseline and at least one post baseline value in full analysis set.||pmol/L||Standard Error|Geometric Mean
709064|NCT00135330|Secondary|Change in Fasting Insulin|Change in fasting insulin from baseline to week 20.|Week 20|All patients who have both baseline and at least one post baseline value in full analysis set.||uIU/ml||Standard Error|Geometric Mean
709065|NCT00135330|Secondary|Change in Fasting C-peptide|Change in fasting C-peptide from baseline to week 20.|Week 20|Fasting C-peptide was initially identified as an outcome measure, but data for this measure were not subsequently collected at baseline or endpoint.|||||
709066|NCT00135330|Secondary|Change in Fasting Serum Glucose Concentration.|Change in fasting serum glucose concentration from baseline to week 20.|Week 20|All patients who have both baseline and at least one post baseline value in full analysis set.||mmol/L||Standard Error|Least Squares Mean
709067|NCT00135330|Secondary|Change in HbA1c|Change in HbA1c from baseline to week 20.|Week 20|All patients who have both baseline and at least one post baseline value in full analysis set.||Percentage||Standard Error|Least Squares Mean
709068|NCT00135330|Secondary|Change in Incremental for Postprandial C-peptide During Meal Challenge Test (MCT).|Change in incremental for postprandial C-peptide (mmol/L) during MCT from baseline to week 20.|Week 20|All patients in full analysis set who have baseline and endpoint measurement.||mmol/L||Standard Error|Least Squares Mean
709069|NCT00135330|Secondary|Change in Incremental for Postprandial Insulin During Meal Challenge Test (MCT).|Change in incremental for postprandial insulin (mmol/L) during meal challenge test (MCT) from baseline to week 20.|Week 20|All patients in full analysis set who have both baseline and endpoint measurement.||mmol/L||Standard Error|Least Squares Mean
709070|NCT00135330|Secondary|Change in Incremental for Postprandial Glucose During a Meal Challenge Test (MCT).|Change in incremental for postprandial glucose (mmol/L) during a MCT from baseline to week 20.|Week 20|All patients in full analysis set who have both baseline and endpoint measurement.||mmol/L||Standard Error|Least Squares Mean
709071|NCT00135330|Secondary|Change in AUC for C-peptide During a Meal Challenge Test (MCT).|Ratio (value at endpoint divided by value at baseline) of AUC(15-180 min) for C-peptide (nmol-min/L) during a MCT from baseline to week 20.|Week 20|All patients in full analysis set who have both baseline and endpoint measurement.||nmol-min/L||Standard Error|Geometric Mean
709072|NCT00135330|Secondary|Ratio (Value at Endpoint Divided by Value at Baseline) of AUC for Insulin During a Meal Challenge Test (MCT).|Ratio (value at endpoint divided by value at baseline) of AUC (15-180 min) for insulin (uIU-min/ml) during MCT.|Week 20|All patients in full analysis set who have both baseline and endpoint measurement.||uIU-min/ml||Standard Error|Geometric Mean
709073|NCT00135330|Secondary|Change in Insulin iAUC From Baseline to Endpoint.|"Change in insulin iAUC in the first stage(uIU-min/ml) from baseline to week 20. First stage represents the first 10 minutes after reaching a steady state during a hyperglycemic clamp test."|Week 20|All patients in full analysis set who participated in clamp tests and have both baseline and endpoint.||uIU-min/ml||Standard Error|Least Squares Mean
709074|NCT00135330|Secondary|Change in Insulin AUC in the First Stage From Baseline to Endpoint.|"Change in insulin AUC in the first stage(uIU-min/ml) from baseline to week 20. First stage represents the first 10 minutes after reaching a steady state during a hyperglycemic clamp test."|Week 20|All patients in full analysis set who participated in clamp tests and have both baseline and endpoint||uIU-min/ml||Standard Error|Least Squares Mean
709075|NCT00135330|Secondary|Change in Insulin Sensitivity Index as Measured by M-value.|Change of M-Value (mg/kg-min) during hyperinsulinemic euglycemic clamp test from baseline to week 20.|Week 20|All patients in full analysis set who participated in clamp test and have both baseline and endpoint measurements.||mg/kg-min||Standard Error|Least Squares Mean
709076|NCT00135330|Secondary|Change in AUC for Glucose During a Meal Challenge Test (MCT).|Change in AUC(15-180 min) for glucose during a MCT baseline to week 20.|Week 20|All patients in full analysis set who have both baseline and endpoint measurement.||mmol-min/L||Standard Error|Least Squares Mean
709077|NCT00135330|Primary|Change in ASIiAUC During a Hyperglycemic Clamp Test.|Change in insulin incremental area under the concentration-time curve (ASIiAUC) from baseline to week 20. ASIiAUC is a measure of beta-cell function.|20 weeks|All patients in full analysis set who participated in clamp test and have both baseline and endpoint measurement.||uIU-min/ml||Standard Error|Least Squares Mean
709078|NCT00135356|Secondary|Mean Change From Baseline in CD4 Count|Mean change from baseline in CD4 count among treated subjects|Baseline, Week 48, Week 96|Observed Cases (OC)||cells/mm3||Standard Error|Mean
709106|NCT00135798|Secondary|Patients With Combined Virologic Response (CVR): Intent-to-Treat Analyses (ITT)|Intent-to-Treat (ITT) analyses of all patients. Combined Virologic Response (CVR), which includes both sustained virologic response pre-transplant (SVR) and post-transplant virologic response (pTVR)|Pre-transplant and 3 months post-transplant|All study patients||participants|||Number
709079|NCT00135356|Secondary|Kaplan-Meier Cumulative Proportion of Participants Without Virologic Rebound (HIV RNA ≥400 c/mL) at Timepoints up to Week 96 in Treated Participants With HIV RNA <400 c/mL at Baseline|Virologic rebound was measured from the first dose of study therapy to the first of the 2 consecutive measurements ≥400 c/mL. Time to virologic rebound was analyzed using life tables. Measured Values show the Kaplan-Meier cumulative proportion of participants without virologic rebound up to the end of the respective interval.|Weeks 8-12, Weeks 20-24, Weeks 32-36, Weeks 44-48, Weeks 56-60, Weeks 68-72, Weeks 80-84, Weeks 92-96|Treated subjects with HIV RNA <400 c/mL at baseline.||Proportion of participants|||Number
709080|NCT00135356|Secondary|Percentage of Participants With Adverse Events (AEs) Leading to Discontinuation|Percentage of Participants with AEs leading to discontinuation of study therapy. An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. All events listed in this table were SAEs, except for renal impairment and hypertriglycerideamia, which were an AEs (and did not meet the 5 percent threshold reported in Adverse Event module of this record).|Through Week 96|Treated subjects||Percent of Participants|||Number
709081|NCT00135356|Secondary|Percentage of Participants With Abnormal Liver Function Tests|Percentage of participants with Abnormal Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Total Bilirubin (TBILI) measurements. Values for liver tests are graded using the modified World Health Organization (WHO) criteria. Grade 1 is mild, grade 2 is moderate, grade 3 is severe, grade 4 is life threatening or disabling.|Week 48, Week 96|All treated participants||Percentage of Participants|||Number
709082|NCT00135356|Secondary|Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation|Percentage of Participants with AEs, Serious AEs (SAEs), Deaths, and AEs leading to discontinuation. An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|Through Week 96 of study therapy|Treated participants||Percentage of Participants|||Number
709083|NCT00135356|Secondary|Mean Changes From Baseline in Waist-to-Hip Ratio at Week 48 and Week 96|Mean changes from baseline in proportion of waist to hip measurements.|Baseline, Week 48, Week 96|LOCF; n=number of participants with baseline value and value at or before analysis timepoint||ratio||Standard Error|Mean
709084|NCT00135356|Secondary|Mean Changes From Baseline in Body Mass Index at Week 48 and Week 96||Baseline, Week 48, Week 96|LOCF; n=number of participants with baseline value and value at or before analysis timepoint||kg/m2||Standard Error|Mean
709085|NCT00135356|Secondary|Mean Changes From Baseline in Waist Circumference at Week 48 and Week 96||Baseline, Week 48, Week 96|LOCF; n=number of participants with baseline value and value at or before analysis timepoint||cm||Standard Error|Mean
709086|NCT00135356|Secondary|Mean Changes From Baseline in Body Weight at Week 48 and Week 96||Baseline, Week 48, Week 96|LOCF; n=number of participants with baseline value and value at or before analysis timepoint||kg||Standard Error|Mean
709087|NCT00135356|Secondary|Mean Changes From Baseline in Fasting Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)|HOMA-IR is an index used in evaluation of obese patients at risk for type 2 diabetes which requires fasting glucose and insulin concentrations. It is a mathematical model based on the theory of a negative feedback loop between the liver and β-cells that regulates both fasting glucose and insulin concentrations and can be used to estimate pancreatic β-cell function and degree of insulin resistance. HOMA-IR normal values are between 2 and 2.5. HOMA-IR ≥ 2.5 indicates insulin-resistance.|Baseline, Week 48, Week 96|Treated participants (LOCF); n=number of participants with baseline value at or before analysis timepoint.||mg/dL x uU/mL||Standard Error|Mean
709088|NCT00135356|Secondary|Mean Changes From Baseline in Fasting Insulin at Week 48 and Week 96||Baseline, Week 48, Week 96|Treated participants (LOCF); n=number of participants with baseline value at or before analysis timepoint.||microunits per milliliter||Standard Error|Mean
709089|NCT00135356|Secondary|Mean Changes From Baseline in Fasting Glucose at Week 48 and Week 96||Baseline, Week 48, Week 96|Treated participants (LOCF); n=number of participants with baseline value at or before analysis timepoint.||mg/dL||Standard Error|Mean
709090|NCT00135356|Secondary|Mean Percent Changes From Baseline in Fasting Lipids|Mean percent changes from baseline in fasting total, low-density lipoprotein (LDL), high-density lipoprotein (HDL), and non-HDL cholesterol, triglycerides, and apolipoprotein B|Baseline, Week 48, Week 96|Treated Subjects (LOCF). n=56 for LDL cholesterol in the PI/RTV arm at both timepoints||Percent change|||Number
709091|NCT00135356|Secondary|Mean Percent Change From Baseline in Total Body Fat by DEXA and in Total Adipose Tissue (TAT) Area by CT Scans|The mean percent change from baseline in total body fat by DEXA and in total adipose tissue (TAT) area by CT scans. Total body fat and TAT are both associated many factors (trunk fat + limb fat + other [weight, etc]), and thus clinical improvement cannot be predicted based solely an increase or decrease of these values. (Baseline values can be found in the Baseline Characteristics section.)|Baseline, Week 48, Week 96|TAT analysis population=treated subjects with adipose tissue pairs (LOCF); trunk fat analysis population=treated subjects with fat pairs (LOCF); n=number of subjects with measurement at baseline and at or before the analysis timepoint||percent change||Inter-Quartile Range|Mean
709092|NCT00135356|Secondary|Mean Percent Change From Baseline in Peripheral Adipose Tissue (Limb Fat) by DEXA and by Changes in Subcutaneous Adipose Tissue (SAT) Area by CT Scans|The mean percent change from baseline in physical signs of lipoatrophy, as assessed objectively by changes in peripheral adipose tissue (ie, limb fat (kg) by DEXA and in subcutaneous adipose tissue (SAT) area by CT scans. Clinical improvement is associated with stable values, or an increase in values. (Baseline values can be found in the Baseline Characteristics section.)|Baseline, Week 48, Week 96|SAT analysis population=treated subjects with adipose tissue pairs (LOCF); trunk fat analysis population=treated subjects with fat pairs (LOCF); n=number of subjects with measurement at baseline and at or before analysis timepoint.||percent change||Inter-Quartile Range|Mean
709105|NCT00135798|Primary|Patients Who Are Negative for HCV RNA at 3 Months Post-transplant: Per-Protocol Analysis (PP)|Post-transplant virologic response (pTVR) defined as undetectable HCV RNA at week 12 after liver transplantation, analysed among patients who received treatment.|3 months post-transplant|Per-Protocol (PP) analyses of Transplanted patients who received treatment. Outcome is pTVR (post-transplant viral response)||participants|||Number
709093|NCT00135356|Secondary|Mean Percent Change From Baseline in Visceral Adipose Tissue (VAT) Area by Computed Tomography (CT) Scans and in Trunk Fat by DEXA.|The mean percent change from baseline in physical signs of lipohypertrophy, as assessed objectively by changes in visceral adipose tissue (VAT) area (cm2) by computed tomography (CT) scans and by changes in trunk fat (kg) by DEXA. Clinical improvement is associated with a decrease in values. (Baseline values can be found in the Baseline Characteristics section.)|Baseline, Week 48, Week 96|VAT analysis population=treated subjects with adipose tissue pairs (LOCF); trunk fat analysis population=treated subjects with fat pairs (LOCF); n=number of subjects with measurement at baseline and at or before the analysis timepoint.||Percent change||Inter-Quartile Range|Mean
709094|NCT00135356|Secondary|Change From Baseline in Trunk-to-limb Fat Ratio as Measured by DEXA at Week 96|Mean changes from baseline in trunk-to-limb fat ratio as measured by DEXA, an x-ray scan used to measure bone mineral density. Clinical improvement is associated with a decrease in values.(Baseline trunk-to-limb fat ratio values can be found in the Baseline Characteristics section.)|Baseline, Week 96|Observed case (OC) analysis: n=participants with fat measurement at baseline and at the analysis timepoint. Last observation carried forward (LOCF): n=participants with fat measurement at baseline and at or before the analysis timepoint.||ratio||Standard Error|Mean
709095|NCT00135356|Primary|Change From Baseline in Trunk-to-limb Fat Ratio as Measured by Dual Energy X-Ray Absortiometry (DEXA) at Week 48|Mean changes from Baseline in trunk-to-limb fat ratio as measured by DEXA, an x-ray scan used to measure bone mineral density. Clinical improvement is associated with a decrease in values. (Baseline trunk-to-limb fat ratio values can be found in the Baseline Characteristics section.)|Baseline, Week 48|Treated participants. Observed case (OC) analysis: n=participants with fat measurement at baseline and at the analysis timepoint. Last observation carried forward (LOCF): n=participants with fat measurement at baseline and at or before the analysis timepoint.||ratio||Standard Error|Mean
709096|NCT00135694|Secondary|Total Burden of Immunosuppression From Random Assignment to Month 24|Total immunosuppression score in units taken as the sum of units per day over the 2-year period from randomization to Month 24 post-randomization. Daily doses were assigned a score of 1 unit as follows: tacrolimus 1 mg, cyclosporine 100 mg, Sirolimus 1 mg, mycophenolate mofetil 1000 mg, Mycophenolic acid 720 mg, azathioprine 50 mg, and prednisone 5 mg. Any antibody use equaled 20 units. Unit scores based on Vasudev (Vasudev B, Hariharan S, Hussain SA, Zhu YR, Bresnahan BA et al. BK virus nephritis: risk factors, timing, and outcome in renal transplant recipients. Kidney Int. 2005; 8(4):1834-1839.).|Randomization to Month 24 post-randomization|Randomized participants still being followed 24 months post-randomization.||units||Full Range|Mean
709097|NCT00135694|Secondary|Total Immunosuppression From Month 21 to Month 24 Post-randomization|Daily immunosuppression score in units per day averaged over the 3-month period from Month 21 to Month 24 post-randomization. Daily doses were assigned a score of 1 unit as follows: tacrolimus 1 mg, cyclosporine 100 mg, Sirolimus 1 mg, mycophenolate mofetil 1000 mg, Mycophenolic acid 720 mg, azathioprine 50 mg, and prednisone 5 mg. Any antibody use equaled 20 units. Unit scores based on Vasudev (Vasudev B, Hariharan S, Hussain SA, Zhu YR, Bresnahan BA et al. BK virus nephritis: risk factors, timing, and outcome in renal transplant recipients. Kidney Int. 2005; 8(4):1834-1839.)|Month 21 to Month 24 post-randomization|Randomized participants still being followed 24 months post-randomization.||units per day||Full Range|Mean
709098|NCT00135694|Secondary|Number of Participants Experiencing Graft Loss or Death|Number of participants with graft loss or death. Graft loss is defined as subject death or re-transplantation.|Randomization to 2 years post-randomization.|Randomized participants (intent-to-treat sample)||participants|||Number
709099|NCT00135694|Secondary|Number of Hepatitis C Infected Participants With Progression of Hepatitis C Related Liver Disease, Defined as Stage 4 or Higher Fibrosis on the Ishak Scale|Number of subjects with a biopsy showing stage 4 fibrosis or higher on the Ishak scale. Stage 4 represents at least 13.7% fibrosis measurement with a description of fibrous expansion of portal areas with marked bridging (P-P) as well as portal to central (P-C). Stage 5 is marked bridging (P-P and/or P-C), with occasional nodules (incomplete cirrhosis) and stage 6 is cirrhosis, probable or definite.|Randomization to 2 years post-randomization.|Hepatitis C infected participants randomized.||participants|||Number
709100|NCT00135694|Secondary|Immunosuppression-free Duration|Time (in days) from withdrawing off of all immunosuppressive drugs to re-starting immunosuppression or study termination/completion.|Discontinuation of all immunosuppression to end of trial participation or to time of restarting immunosuppression, whichever came first, assessed up to two years|Participants randomized to immunosuppression withdrawal who completed withdrawal and discontinued all immunosuppression||Days||Full Range|Mean
709101|NCT00135694|Secondary|Number of Participants Who Successfully Stop Taking Immunosuppression for at Least 6 Months||Randomization until study completion or participant termination (up to six years post-transplant)|Participants randomized to immunosuppression withdrawal||participants|||Number
709102|NCT00135694|Secondary|Number of Participants Who Qualify for Random Assignment||One to two years post-transplantation|All subjects transplanted||participants|||Number
709103|NCT00135694|Primary|Number of Participants With Clinical Complications Usually Attributed to Immunosuppression|This is a composite endpoint comprising clinical complications related to immunosuppression and is defined as the occurrence of any of the following: death or graft loss, grade 4 secondary malignancy (graded by Common Terminology Criteria for Adverse Events [CTCAE] version 3.0), grade 4 opportunistic infection (graded by CTCAE version 3.0), stage 3 or higher fibrosis, or decrease in renal function. Decrease in renal function is defined as: a) the estimated glomerular filtration rate (eGFR) using creatinine obtained prior to and closest to randomization will be considered the baseline and will be compared to the eGFR using creatinine obtained at 24 months +/- 3 months after randomization; b) for those with a baseline eGFR 30-90 ml per min per 1.73 meter-squared, a 25% decrease in eGFR; c) for those with a baseline eGFR greater than 90 ml per min per 1.73 meter-squared, a 25% decrease in eGFR and a decrease in eGFR to less than 90 ml per min per 1.73 meter-squared.|Randomization to 2 years post-randomization|Evaluable randomized subjects having a targeted event and/or having available data for calculation of eGFR||participants|||Number
709104|NCT00135798|Secondary|Patients With Combined Virologic Response (CVR): Per-Protocol Analysis (PP)|Per-Protocol (PP) analyses of all patients. Combined Virologic Response (CVR)includes both sustained virologic response pre-transplant (SVR) and post-transplant virologic response (pTVR), analysed among patients who received treatment.|Pre-transplant and 3 months post-transplant|All study patients||participants|||Number
709248|NCT00147277|Secondary|Compare Likelihood of Syncopal Events Associated With FVT||one year||||||
709107|NCT00135798|Primary|Patients Who Are Negative for Hepatitis C Virus (HCV) RNA at 3 Months Post-transplant: Intent-to-Treat Analysis (ITT)|Post-transplant virologic response (pTVR) defined as undetectable HCV RNA at week 12 after liver transplantation.|3 months post-transplant|Intent-to-Treat (ITT) analyses of Transplanted patients assigned to treatment. Outcome is pTVR (post-transplant viral response)||participants|||Number
709108|NCT00136084|Secondary|Relationship of Inhibition of DNA Synthesis and Clinical Response|Clinical response is defined as MRD (minimal residual disease) measured by flow cytometry at day 22. The MRD at day 22 is classified as positive (with MRD) or negative (no detectable MRD). The relation between inhibition of DNA synthesis and MRD was performed by logistic regression. In the model, logit of probability of MRD positive was regressed on inhibition of DNA synthesis.|Measurements were assessed in Induction I chemotherapy|Of 232 eligible patients, 49 had DNA synthesis rate performed prior to araC treatment. Of the 49 patients, 23 had no 24-hr samples and 3 did not have enough cells in 24-hr samples. 21 patients with both pre and post araC samples were included in the DNA inhibition study. 17 of the 21 patients had evaluable day 22 MRD.||Percent inhibition of DNA Synthesis||Standard Error|Mean
709109|NCT00136084|Secondary|To Assess Whether Inhibition of DNA Synthesis is Greater After High-dose Ara-C (HDAC) Than After Low-dose Ara-C (LDAC) Therapy|Inhibition of DNA synthesis is defined as the percentage of DNA synthesis rate at 24-hour post-araC treatment over DNA synthesis rate pre-araC treatment.|Measurements were assessed in Induction I chemotherapy|Of 232 eligible patients, 49 had DNA synthesis rate performed prior to araC treatment. Of the 49 patients, 23 had no 24-hr samples and 3 did not have enough cells in 24-hr samples. 21 patients with both pre and post araC samples were included in the DNA inhibition study. Of the 21 patients, 9 were treated on HDAC and 12 were treated on LDAC.||Percent Inhibition of DNA Synthesis||Standard Error|Mean
709110|NCT00136084|Secondary|To Estimate the Overall Event-free Survival (EFS) of AML Patients Who Undergo Risk-adapted and Genotype-directed Therapy|Overall event-free survival (EFS) was defined as the time from study enrollment to induction failure, relapse, secondary malignancy, death, or study withdrawal for any reason, with event-free patients censored on the date of the last follow-up|Five Year|238 patients were enrolled on the study. Out of 238, 6 were determined to be ineligible and 2 were not randomized. Of the 230 patients, 14 bi-phenotypic leukemia patients were excluded. 216 AML patients were included to estimate EFS.||Percentage of Participants|||Number
709111|NCT00136084|Secondary|Proportion of Patients Experienced Toxicity of Cytarabine + Daunomycin + Etoposide (ADE) + GO.|To estimate proportion of patients experiencing CTC Grade 3 or 4 toxicity during Induction II (Cytarabine + Daunomycin + Etoposide (ADE) + GO), who had no response to first course of induction therapy|Induction II|30 patients received ADE + GO during induction II and were analyzed. Out of the 30 patients, 11 patients were treated on HDAC arm, and 19 patients were treated on LDAC arm.||Participants|||Number
709112|NCT00136084|Secondary|Proportion of MRD Reduction After One Course of Cytarabine + Daunomycin + Etoposide (ADE) + GO|To estimate proportion of patients with MRD reduction after one course of Induction II (cytarabine + daunomycin + etoposide (ADE) + GO), who had no response to first course of induction therapy.|Induction II|Out of the 30 patients received ADE + GO treatment, one patient had inevaluable MRD prior to and after the treatment. 29 patients were analyzed. Out of the 29 patients, 10 patients were treated on HDAC arm and 19 patients were treated on LDAC arm.||Participants|||Number
709113|NCT00136084|Secondary|Proportion of Minimal Residual Disease (MRD)+ Patients Who Become MRD- After One Course of Gemtuzumab Ozogamicin (GO)|To estimate the proportion of minimal residual disease (MRD)+ patients who become MRD- after one course of gemtuzumab ozogamicin (GO)|Consolidation I|Sixteen patients received GO treatment during consolidation I. One patient with negative MRD received GO treatment, which was not consistent with the protocol definition. 15 patients were analyzed. Out of the 15 patients, 7 patients were treated on HDAC arm and 8 patients were treated on LDAC arm.||Participants|||Number
709114|NCT00136084|Primary|Minimal Residual Disease (MRD).|Detection of Minimal Residual Disease following one course of chemotherapy where positive MRD was defined as one or more leukemic cell per 1000 mononuclear bone-marrow cells (>=0.1%).|Day 22 MRD measurement|Of the 223 randomized patients, 205 patients were included in the day 22 MRD analysis. 18 patients were not included in the day 22 MRD analysis. 5 patients had inadequate sample for MRD, 11 patients had no suitable phenotype to determine MRD, 1 patient was not done on MRD, and 1 patient was lost for follow-up.||participants|||Number
709115|NCT00136318|Secondary|Safety||assessed 2,4,12,24 and for genotype 1 and 4, 48 weeks of antiviral treatment||||||
709116|NCT00136318|Secondary|Tolerability||assessed 2,4,12,24 and for genotype 1 and 4, 48 weeks of antiviral treatment||||||
709117|NCT00136318|Secondary|Sustained Virologic Response|(negative Polymerase Chain Reaction (PCR) 6 months after the end of antiviral treatment)|assessed 24 weeks after end of antiviral treatment|The final analysis included only patients who received at least 1 dose of escitalopram or placebo. Between-group differences for the secondary outcome parameters were calculated with a chi-square test.||percentage of participants||95% Confidence Interval|Number
709118|NCT00136318|Secondary|Health Related Quality of Life (HRQOL) Measured by the Short Form 36 (SF-36)||assessed 2,4,12,24 and 48 weeks of antiviral treatment||||||
709119|NCT00136318|Secondary|Severe Depression Defined as a MADRS Score of 25 or Higher||severe depression during 24 or 48 weeks of antiviral therapy|The final analysis included only patients who received at least 1 dose of escitalopram or placebo. Between-group differences for the secondary outcome parameters were calculated with a chi-square test.||percentage of participants||95% Confidence Interval|Number
709120|NCT00136318|Secondary|Incidence of Major Depression Defined by Diagnostic and Statistical Manual IV (DSM-IV) Criteria||major depression during 24 or 48 weeks of antiviral therapy|The final analysis included only patients who received at least 1 dose of escitalopram or placebo. Between-group differences for the secondary outcome parameters were calculated with a chi-square test.||percentage of participants||95% Confidence Interval|Number
709121|NCT00136318|Secondary|Proportion of Patients Without Depression (Defined as a MADRS Score of 13 or Higher)|Number of patients who did not develop at any time of antiviral treatment (up to 48 weeks) a MADRS score of 13 or more as a sign of clinically relevant depression|Patients free of depression during 24 or 48 weeks of antiviral therapy|Number of patients per group who did not develop any depressive episode during 48 weeks of antiviral therapy.||participants|||Number
709249|NCT00147277|Secondary|Percent Reduction in Shocks Delivered Per Patient for Treating FVT||one year||||||
709122|NCT00136318|Primary|Montgomery Asberg Depression Scale (MADRS) With a Score of 13 or Higher|"Clinically relevant depression (MADRS score of 13 or higher) during antiviral treatment presented as percentage of participants with MADRS scores > 13 (entire time period: from starting study medication until end of antiviral treatment = 48 weeks in patients with genotype 1 or 4 and 24 weeks for patients with genotype 2 or 3)"|50 weeks for genotypes 1 or 4 and 26 weeks for patients with genotype 2 or 3|The final analysis included only patients who received at least one of escitalopram or placebo. Between group differences for the primary outcome parameters were calculated with a chi-square test. For the primary end point (MADRS score of 13 or higher), we treated missing MADRS assessments by multiple imputation.||percentage of participants||95% Confidence Interval|Number
709123|NCT00136357|Primary|Harvard Trauma Questionnaire|The Harvard Trauma Questionnaire measures PTSD Symptoms. This scale has 16 items and is rated on a Likert scale from 1-4. The total score is sum of the scores divided by the number of items. Higher scores indicated higher levels of PTSD symptoms.|Baseline, 12 weeks, 3 months|||units on a scale||Standard Deviation|Mean
709124|NCT00145496|Secondary|Change From Baseline in Body Weight||Day 182|Analysis was intent to treat - subjects who received at least 1 dose of double-blind trial medication and had at least 1 post-baseline value.||kg||Standard Error|Mean
709125|NCT00145496|Secondary|Change From Baseline in Quality of Life Measured by the Quality of Life Scale (QLS) Total Score|The Quality of Life Scale is a 21-item clinician-rated scale for rating psychosocial functioning (Interpersonal Relations, Instrumental Role, Intrapsychic Foundations, and Common Objects and Activities). The score ranges from 0 to 126, with greater values indicating better quality of life.|Day 182|Analysis was intent to treat - subjects who received at least 1 dose of double-blind trial medication and had at least 1 post-baseline value.||Units on a Scale||Standard Error|Mean
709126|NCT00145496|Primary|Change From Baseline in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale Total Score|The NSA Scale is a 16-item clinician-rated instrument for rating the negative symptomatology of schizophrenia. Total score ranges from 16 to 96, with greater scores indicating greater severity of symptoms.|Day 182|Analysis was intent to treat - subjects who received at least 1 dose of double-blind trial medication and had at least 1 post-baseline value.||Units on a Scale||Standard Error|Mean
709127|NCT00145509|Primary|Change From Baseline to Week 52 on the Montgomery Asberg Depression Rating Scale (MADRS) Score|The MADRS is a 10-item clinician-rated scale for assessing the severity of symptoms of depression. MADRS total score range = 0-60; higher scores indicate greater severity of symptoms.|Baseline and 52 Weeks|Intent-to-treat are subjects who took at least one dose of double-blind study medication in the extension study and had at least one Y-MRS and MADRS assessment during the extension study.||Score on a scale||Standard Deviation|Mean
709128|NCT00145509|Primary|Change From Baseline to Week 52 on the Young-Mania Rating Scale (Y-MRS) Score|The Y-MRS is an 11-item, clinician-rated instrument used for assessing the symptoms of mania. Y-MRS total score range = 0-60; higher scores indicate greater severity of symptoms.|Baseline and 52 Weeks|Intent-to-treat are subjects who took at least one dose of double-blind study medication in the extension study and had at least one Y-MRS and MADRS assessment during the extension study.||Score on a Scale||Standard Deviation|Mean
709129|NCT00145509|Primary|Number of Participants Who Discontinued Because of an Adverse Event|Participants who discontinued study medication due to adverse events.|40 weeks|||participants|||Number
709130|NCT00145509|Primary|Number of Participants Who Experienced an Adverse Event|Participants who experienced treatment-emergent adverse events, defined as adverse events reported on or after the first dose of study medication in the 12-week lead-in study through the last dose of study drug + 7 days (or + 30 days for serious adverse events).|up to 52 weeks|||Participants|||Number
709131|NCT00145574|Secondary|Percent Change in Apolipoprotein B From Study Baseline (Day 1) to Week 26.|Percent change in apolipoprotein B from baseline to Week 26 was calculated for subpopulations representing each assigned treatment group during the Double blind Period, and for the overall population in the Open Label Extension Period.|26 weeks (week 26 - day 1)|Intent to treat population. Last Observation Carried Forward.||percent change from baseline||Standard Deviation|Mean
709132|NCT00145574|Secondary|Percent Change in Apolipoprotein A-I From Study Baseline (Day 1) to Week 26.|Percent change in apolipoprotein A-I from baseline to Week 26 was calculated for subpopulations representing each assigned treatment group during the Double blind Period, and for the overall population in the Open Label Extension Period.|26 weeks (week 26 - day 1)|Intent to treat population. Last Observation Carried Forward.||percent change from baseline||Standard Deviation|Mean
709133|NCT00145574|Secondary|Percent Change in Non-high-density Lipoprotein Cholesterol From Study Baseline (Day 1) to Week 26.|Percent change in non-high-density lipoprotein cholesterol from baseline to Week 26 was calculated for subpopulations representing each assigned treatment group during the Double blind Period, and for the overall population in the Open Label Extension Period.|26 weeks (week 26 - day 1)|Intent to treat population. Last Observation Carried Forward.||percent change from baseline||Standard Deviation|Mean
709134|NCT00145574|Secondary|Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Study Baseline (Day 1) to Week 26.|Percent change in high-density lipoprotein cholesterol from baseline to Week 26 was calculated for subpopulations representing each assigned treatment group during the Double blind Period, and for the overall population in the Open Label Extension Period.|26 weeks (week 26 - day 1)|Intent to treat population. Last Observation Carried Forward.||percent change from baseline||Standard Deviation|Mean
709135|NCT00145574|Secondary|Percent Change in Triglycerides From Study Baseline (Day 1) to Week 26.|Percent change in triglycerides from baseline to Week 26 was calculated for subpopulations representing each assigned treatment group during the Double blind Period, and for the overall population in the Open Label Extension Period.|26 weeks (week 26 - day 1)|Intent to treat population. Last Observation Carried Forward.||percent change from baseline||Standard Deviation|Mean
709136|NCT00145574|Secondary|Percent Change in Total Cholesterol From Study Baseline (Day 1) to Week 26.|Percent change in total cholesterol (TC) from baseline to Week 26 was calculated for subpopulations representing each assigned treatment group during the Double blind Period, and for the overall population in the Open Label Extension Period.|26 weeks (week 26 - day 1)|Intent to treat population. Last Observation Carried Forward.||percent change from baseline||Standard Deviation|Mean
709250|NCT00147277|Secondary|Acceleration Rate or Degenerated Into VF of ATP for Treating FVT in the 2 Arms||one year||||||
709137|NCT00145574|Secondary|Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Study Baseline (Day 1) to Week 26.|Percent change in low-density lipoprotein cholesterol from baseline to Week 26 was calculated for subpopulations representing each assigned treatment group during the Double blind Period, and for the overall population in the Open Label Extension Period.|26 weeks (week 26 - day 1)|Intent-to-Treat (ITT) Population. Last Observation Carried Forward.||percent change from baseline||Standard Deviation|Mean
709138|NCT00145574|Secondary|Percent Change in Plasma Apolipoprotein B (Apo B) From Day 1 (Study Baseline) to Week 8.|Percent change in Apo B (mg/dL) and standard deviation (SD) from Day 1 (Study Baseline) to Week 8 (last observation carried forward - LOCF)- Intent-to-Treat ITT population.|8 weeks (week 8 - day 1)|Intent-to-Treat (ITT) Population in Double blind Period. Last Observation Carried Forward.||percent change from baseline||Standard Deviation|Mean
709139|NCT00145574|Secondary|Percent Change in Plasma Apolipoprotien A-I (Apo A-1) From Day 1 (Study Baseline) to Week 8.|Percent change in Apolipoprotien A-I (Apo A-1) (mg/dL) and standard deviation (SD) from Day 1 (Study Baseline) to Week 8 (last observation carried forward - LOCF)- Intent-to-Treat ITT population.|8 weeks (week 8 - day 1)|Intent-to-Treat (ITT) Population in Double blind Period. Last Observation Carried Forward.||percent change from baseline||Standard Deviation|Mean
709140|NCT00145574|Secondary|Percent Change in Plasma Non-high Density Lipoprotein-cholesterol (Non-HDL-C) From Day 1 (Study Baseline) to Week 8.|Percent change in non-HDL-C (mg/dL) and standard deviation (SD) from Day 1 (Study Baseline) to Week 8 (last observation carried forward - LOCF)- Intent-to-Treat ITT population.|8 weeks (week 8 - day 1)|Intent-to-Treat Population for Double blind Period. Last Observation Carried Forward.||percent change from baseline||Standard Deviation|Mean
709141|NCT00145574|Secondary|Percent Change in Plasma High-density Lipoprotein-cholesterol (HDL-C) From Day 1 (Study Baseline) to Week 8.|Percent change in HDL-C (mg/dL) and standard deviation (SD) from Day 1 (Study Baseline) to Week 8 (last observation carried forward - LOCF)- Intent-to-Treat ITT population.|8 weeks (week 8 - day 1)|Intent-to-Treat Population for Double blind Period. Last Observation Carried Forward.||percent change from baseline||Standard Deviation|Mean
709142|NCT00145574|Secondary|Percent Change in Plasma Triglycerides (TG) From Day 1 (Study Baseline) to Week 8.|Percent change in triglycerides (mg/dL) and standard deviation (SD) from Day 1 (Study Baseline) to Week 8 (last observation carried forward - LOCF)- Intent-to-Treat ITT population.|8 weeks (week 8 - day 1)|Intent-to-Treat Population for Double blind Period. Last Observation Carried Forward.||percent change from baseline||Standard Deviation|Mean
709143|NCT00145574|Secondary|Percent Change in Plasma Total Cholesterol (TC) From Day 1 (Study Baseline) to Week 8.|Percent change in total cholesterol (mg/dL) and standard deviation (SD) from Day 1 (Study Baseline) to Week 8 (last observation carried forward - LOCF)- Intent-to-Treat ITT population.|8 weeks (week 8 - day 1)|Intent-to-Treat Population for Double blind Period. Last Observation Carried Forward.||percent change from baseline||Standard Deviation|Mean
709144|NCT00145574|Primary|Percent Change in Plasma Low Density Lipoprotein-cholesterol (LDL-C) From Day 1 (Study Baseline) to Week 8.|Percent change in LDL-C (mg/dL) and standard deviation (SD) from Day 1 (Study Baseline)to Week 8 (last observation carried forward - LOCF)- Intent-to-Treat ITT population.|8 weeks (week 8 - day 1)|Intent-to-Treat Population for Double blind Period. Last Observation Carried Forward.||percent change from baseline||Standard Deviation|Mean
709145|NCT00145587|Primary|Engraftment|To determine the need for blood or platelet transfusions and the presence of donor cells being present in the transplant recipient’s bone marrow or peripheral blood by 100 day after transplantation for children with malignant infantile osteopetrosis who have received a haploidentical stem cell graft.|100 days post-transplant|From September 2004 to March 2009, 5 consecutive MIOP patients were treated using mismatched family member donors. Favorable engraftment refers to the transplant patient not requiring blood or platelet transfusions and the presence of donor cells being present in the transplant recipient’s bone marrow or peripheral blood.||Participants|||Number
709146|NCT00145600|Other Pre-specified|Event-free Survival Probability by Risk Group at 10-year Follow-Up|Event-free survival (EFS) is based on the time from protocol enrollment to the occurrence of first event (relapse or progressive disease, subsequent malignancy, or death from any cause). Patients not experiencing an event are censored at their last follow-up date. Event-free Survival Probability will be estimated by Kaplan-Meier method with a 95% confidence interval.|10-year follow-up after protocol enrollment||||||
709147|NCT00145600|Secondary|Correlation of Agreement Between Patient PedsQL3 (Composite) QoL and Parent Proxy PedsQL3 (Composite) QoL at Multiple Time Points.|Assess and compare the patient reported and parent proxy PedsQL3 (composite) quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)|Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month.||units on a scale||Standard Deviation|Mean
709148|NCT00145600|Secondary|Correlation of Agreement Between Patient Communication QoL and Parent Proxy Communication QoL at Multiple Time Points.|Assess and compare the patient reported and parent proxy communication quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)|Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month.||units on a scale||Standard Deviation|Mean
709149|NCT00145600|Secondary|Correlation of Agreement Between Patient Perceived Physical Appearance QoL and Parent Proxy Perceived Physical Appearance QoL at Multiple Time Points.|Assess and compare the patient reported and parent proxy perceived physical appearance quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)|Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month.||units on a scale||Standard Deviation|Mean
709150|NCT00145600|Secondary|Correlation of Agreement Between Patient Cognitive Problems (Child + Teen) QoL and Parent Proxy Cognitive Problems (Child + Teen) QoL at Multiple Time Points.|Assess and compare the patient reported and parent proxy cognitive problems (child + teen) quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)|Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month.||units on a scale||Standard Deviation|Mean
709151|NCT00145600|Secondary|Correlation of Agreement Between Patient Worry QoL and Parent Proxy Worry QoL at Multiple Time Points.|Assess and compare the patient reported and parent proxy worry quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)|Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month.||units on a scale||Standard Deviation|Mean
709152|NCT00145600|Secondary|Correlation of Agreement Between Patient Treatment Anxiety QoL and Parent Proxy Treatment Anxiety QoL at Multiple Time Points.|Assess and compare the patient reported and parent proxy treatment anxiety quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)|Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month.||units on a scale||Standard Deviation|Mean
709153|NCT00145600|Secondary|Correlation of Agreement Between Patient Procedural Anxiety QoL and Parent Proxy Procedural Anxiety QoL at Multiple Time Points.|Assess and compare the patient reported and parent proxy procedural anxiety quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)|Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month.||units on a scale||Standard Deviation|Mean
709154|NCT00145600|Secondary|Correlation of Agreement Between Patient Nausea QoL and Parent Proxy Nausea QoL at Multiple Time Points.|Assess and compare the patient reported and parent proxy nausea quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)|Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month.||units on a scale||Standard Deviation|Mean
709251|NCT00147277|Secondary|Efficacy of ATP in Successfully Treating FVT for Patients in Primary and Secondary Prevention||one year||||||
709155|NCT00145600|Secondary|Correlation of Agreement Between Patient Pain and Hurt QoL and Parent Proxy Pain and Hurt QoL at Multiple Time Points.|Assess and compare the patient reported and parent proxy pain and hurt quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5).|Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month.||units on a scale||Standard Deviation|Mean
709156|NCT00145600|Secondary|Correlation of Agreement Between Patient Peds QL4 (Composite) QoL and Parent Proxy Peds QL4 (Composite) QoL at Multiple Time Points.|Assess and compare the patient reported and parent proxy Peds QL4 (composite) quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5).|Each participating institution made the decision to complete or not complete the QoL secondary aim. Of 296 eligible participants, 178 participated in the QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy.||units on a scale||Standard Deviation|Mean
709157|NCT00145600|Secondary|Correlation of Agreement Between Patient Psychosocial QoL and Parent Proxy Psychosocial QoL at Multiple Time Points.|Assess and compare the patient reported and parent proxy psychosocial quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5).|Each participating institution made the decision to complete or not complete the QoL secondary aim. Of 296 eligible participants, 178 participated in the QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy.||units on a scale||Standard Deviation|Mean
709158|NCT00145600|Secondary|Correlation of Agreement Between Patient School QoL and Parent Proxy School QoL at Multiple Time Points.|Assess and compare the patient reported and parent proxy school quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5).|Each participating institution made the decision to complete or not complete the QoL secondary aim. Of 296 eligible participants, 178 participated in the QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy.||units on a scale||Standard Deviation|Mean
709159|NCT00145600|Secondary|Correlation of Agreement Between Patient Social QoL and Parent Proxy Social QoL at Multiple Time Points.|Assess and compare the patient reported and parent proxy social quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5).|Each participating institution made the decision to complete or not complete the QoL secondary aim. Of 296 eligible participants, 178 participated in the QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy.||units on a scale||Standard Deviation|Mean
709160|NCT00145600|Secondary|Correlation of Agreement Between Patient Emotional QoL and Parent Proxy Emotional QoL at Multiple Time Points.|Assess and compare the patient reported and parent proxy emotional quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5).|Each participating institution made the decision to complete or not complete the QoL secondary aim. Of 296 eligible participants, 178 participated in the QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy.||units on a scale||Standard Deviation|Mean
709161|NCT00145600|Secondary|Correlation of Agreement Between Patient Physical QoL and Parent Proxy Physical QoL at Multiple Time Points.|Assess and compare the patient reported and parent proxy physical quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5).|Each participating institution made the decision to complete or not complete the QoL secondary aim. Of 296 eligible participants, 178 participated in the QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy.||units on a scale||Standard Deviation|Mean
709162|NCT00145600|Primary|Event-free Survival Probability by Risk Group|Event-free survival (EFS) is based on the time from protocol enrollment to the occurrence of first event (relapse or progressive disease, subsequent malignancy, or death from any cause). Patients not experiencing an event are censored at their last follow-up date. Event-free Survival Probability will be estimated by Kaplan-Meier method with a 95% confidence interval.|Median 6.4 year follow-up|Nine patients were ineligible for analysis.||probability of 5 yr. event free survival||95% Confidence Interval|Number
709163|NCT00145626|Secondary|Kinetics of Lymphohematopoietic Reconstitution|The lymphohematopoietic reconstitution will be summarized using summary statistics and assessed in a longitudinal manner and analyzed accordingly.|From 0-3 months after HSCT through 4-5 years after HSCT|Data was not available for analysis for all patients at all time points.||cells *10^3/µl||Full Range|Median
709164|NCT00145626|Secondary|Frequency of and Clinical Relevance of Minimal Residual Disease (MRD) Before and After Transplantation|The presence or absence of MRD before and after the bone marrow transplant (BMT) and its frequency distribution will be obtained for each time point separately.|Baseline before HSCT, 1 year post HSCT, and up to 5 years post HSCT|MRD data was collected on only four participants during at least one time point.||Participants|||Count of Participants
709165|NCT00145626|Secondary|Incidence of and Risk Factors for Long-term Neurocognitive Deficit.|The long-term neurocognitive deficit will be summarized using summary statistics and assessed in a longitudinal manner and analyzed accordingly.|Up to 5 Years after transplant|There was not enough data available after 1 year post-transplant to evaluate long term outcomes on this study.|||||
709166|NCT00145626|Secondary|Incidence of and Risk Factors for Organ Dysfunction.|The organ dysfunction will be summarized using summary statistics and assessed in a longitudinal manner and analyzed accordingly.|Up to 5 Years after transplant|There was not enough data available after 1 year post-transplant to evaluate long term outcomes on this study.|||||
709167|NCT00145626|Secondary|Factors Affecting One-year Survival: Minimal Residual Disease (MRD)|Detection of leukemia blasts in bone marrow by flow cytometry|Up to one year after transplant|Only four of the 14 participants had MRD measured at the one-year time point.||participants|||Number
709168|NCT00145626|Secondary|Factors Affecting One-year Survival: Match N/6 HLA Loci|HLA typing determined the degree of match by looking at 6 different HLA loci. The results indicate the number of the 6 loci that matched for each participant. Due to small sample size (n=14) and total number of events (n=7), the analysis to check the various factors that affect the one-year survival was not performed (using logistic and cox model).|Up to one year after transplant|||participants|||Number
709169|NCT00145626|Secondary|Factors Affecting One-year Survival: Donor Type|Due to small sample size (n=14) and total number of events (n=7), the analysis to check the various factors that affect the one-year survival was not performed (using logistic and cox model).|Up to one year after transplant|||participants|||Number
709170|NCT00145626|Secondary|Factors Affecting One-year Survival: Disease Status at HSCT|Due to small sample size (n=14) and total number of events (n=7), the analysis to check the various factors that affect the one-year survival was not performed (using logistic and cox model).|Up to one year after transplant|||participants|||Number
709171|NCT00145626|Secondary|Factors Affecting One-year Survival: Median Dose of NK Cells|Due to small sample size (n=14) and total number of events (n=7), the analysis to check the various factors that affect the one-year survival was not performed (using logistic and cox model).|Up to one year after transplant|||NKcells X 10^6/kg||Full Range|Median
709172|NCT00145626|Secondary|Factors Affecting One-year Survival: Median Dose of CD34|Due to small sample size (n=14) and total number of events (n=7), the analysis to check the various factors that affect the one-year survival was not performed (using logistic and cox model).|Up to one year after transplant|||CD34 X 10^6/kg||Full Range|Median
709173|NCT00145626|Secondary|Factors Affecting One-year Survival: Median Age of Donor at HSCT|Due to small sample size (n=14) and total number of events (n=7), the analysis to check the various factors that affect the one-year survival was not performed (using logistic and cox model).|Up to one year after transplant|||Years||Full Range|Median
709174|NCT00145626|Secondary|Number of Incidences of Chronic GVHD.|"Chronic GVHD was graded according to Seattle Criteria: limited or extensive. Limited is defined as localized skin and/or hepatic dysfunction. Extensive is defined as one or more of the following:
generalized skin involvement
liver histology showing chronic aggressive hepatitis, bridging necrosis or cirrhosis
eye dryness with Schirmer's test <5 mm wetting
oral: involvement of salivary glands or oral mucosa
other: another target organ involvement"|Up to 5 years after transplant|||Participants|||Count of Participants
709175|NCT00145626|Secondary|Number of Transplant-Related Adverse Outcomes: Fatal Acute Graft-Versus Host Disease (GVHD)|The cumulative incidence estimate for occurrence of fatal acute GVHD by the end of the first 100 days post-transplant was calculated using method of Kalbfleisch and Prentice.|100 days post-transplantation|||Number of Deaths|||Number
709176|NCT00145626|Secondary|Number of Transplant-Related Adverse Outcomes: Engraftment Failure|Engraftment failure is defined as <10% donor cell chimerism at any time point between 28 and 100 days after transplant with no evidence of disease relapse or requiring stem cell boost.|100 days post-transplantation|||proportion of engraftment failures||95% Confidence Interval|Number
709177|NCT00145626|Secondary|Number of Transplant-Related Adverse Outcomes: Regimen-Related Mortality|The cumulative incidences of regimen-related mortality will be estimated using method of Kalbfleisch and Prentice.|100 days post-transplantation|||participants|||Number
709178|NCT00145626|Primary|One-year Survival|"The one-year survival of infants with high-risk hematologic malignancies who receive a haploidentical transplant procedure using a total body irradiation (TBI)-excluding conditioning regimen followed by an HLA-nonidentical family donor hematopoietic stem cell (HSC) graft depleted of T cells ex vivo using the CliniMACS CD34+ selection system, with a subsequent infusion of donor NK cells purified ex vivo using the CliniMACS CD3+ depletion and CD56+ enrichment system.
The Kaplan-Meier estimate for one-year survival is reported."|One year after transplant|||percentage of participants|||Number
709179|NCT00145704|Primary|Change in Total Body Bone Mineral Density During an 18 Month Period|For those patients already on growth hormone replacement therapy, growth hormone will be administered as per standard of care, with standard dose ranges adjusted based upon IGF-1 monitoring. Those patients not currently receiving growth hormone replacement therapy will not be placed on therapy as a part of this study. Patients on and off growth hormone replacement therapy will be randomized in a block design to the two treatment arms to assure equal numbers in each treatment arm. The bisphosphonate to be utilized will be provided to the Arm II patients at no charge. All Arm II patients will receive the same bisphosphonate regimen, Risedronate 35 mg per oral once weekly for 18 months. All patients on arms I and II will also receive Vitamin D (400 IU p.o. daily) and calcium carbonate (500 mg p.o. twice daily) free of charge for eighteen months.|18 months|Data analyis halted, due to low enrollment,no outcomes to report|||||
709180|NCT00145795|Secondary|Rates of Virologic Failure|Virologic failure defined as HIV RNA > 2,000 copies/mL|6 months|||percentage of randomized subjects|||Number
709181|NCT00145795|Secondary|Clinical HIV-related Events|"Number of participants experiencing clinical HIV-related events as defined by category A, category B, and Appendix B in the 1993 Revised Classification System for HIV Infection and Expanded Surveillance Case Definition for AIDS Among Adolescents and Adults (http://www.cdc.gov/mmwr/preview/mmwrhtml/00018871.htm)."|6 months|||number of participants with event(s)|||Number
709182|NCT00145795|Secondary|Rates of ex Vivo T Cell Apoptosis: CD8+ Cell Population [6 Months]||6 months|||percent apoptosis||Standard Deviation|Mean
709183|NCT00145795|Secondary|Rates of ex Vivo T Cell Apoptosis: CD8+ Cell Population [3 Months]||3 months|||percent apoptosis||Standard Deviation|Mean
709184|NCT00145795|Secondary|Rates of ex Vivo T Cell Apoptosis: CD4+ naïve Cell Population [6 Months]||6 months|||percent apoptosis||Standard Deviation|Mean
709185|NCT00145795|Secondary|Rates of ex Vivo T Cell Apoptosis: CD4+ Memory Cell Population [6 Months]||6 months|||percent apoptosis||Standard Deviation|Mean
709186|NCT00145795|Secondary|Rates of ex Vivo T Cell Apoptosis: CD4+ naïve Cell Population [3 Months]|Ex vivo T cell apoptosis can be assessed many different ways. The use of propidium iodide staining to determine the proportion of isolated cells that have undergone apoptosis after ex vivo incubation is a standard method that has been used by many investigators. Apoptotic cells intercalate less PI into their DNA, and on flow cytometry, this cell population is identified by a decrease in mean fluorescence (shift to the left). We have experience with this assay, and we have published on the use of method for determining rates of ex vivo apoptosis for different immune effector cells.|3 months|||percent apoptosis||Standard Deviation|Mean
709187|NCT00145795|Secondary|Rates of ex Vivo T Cell Apoptosis: CD4+ Memory Cell Population [3 Months]|Ex vivo T cell apoptosis can be assessed many different ways. The use of propidium iodide staining to determine the proportion of isolated cells that have undergone apoptosis after ex vivo incubation is a standard method that has been used by many investigators. Apoptotic cells intercalate less PI into their DNA, and on flow cytometry, this cell population is identified by a decrease in mean fluorescence (shift to the left). We have experience with this assay, and we have published on the use of method for determining rates of ex vivo apoptosis for different immune effector cells.|3 months|||percent apoptosis||Standard Deviation|Mean
709188|NCT00145795|Primary|Immune Reconstitution [6 Months]|Immune reconstitution is defined as the absolute CD4+ lymphocyte count after 6 months of therapy. Absolute CD4+ T cell count, our measure of immune recovery, was assessed in the clinical laboratory using fluorescent labeled monoclonal antibodies to the CD4 on lymphocytes. This is the main target cell for HIV infection. The absolute CD4+ T cell count is also the only clinically validated surrogate marker of immune dysfunction in HIV. CD4+ count is also our best predictor of morbidity and mortality outcomes.|6 months|||cells per cubic millimeter||Standard Deviation|Mean
709189|NCT00145795|Primary|Immune Reconstitution [3 Months]|Immune reconstitution is defined as the absolute CD4+ lymphocyte count after 3 months of therapy. Absolute CD4+ T cell count, our measure of immune recovery, was assessed in the clinical laboratory using fluorescent labeled monoclonal antibodies to the CD4 on lymphocytes. This is the main target cell for HIV infection. The absolute CD4+ T cell count is also the only clinically validated surrogate marker of immune dysfunction in HIV. CD4+ count is also our best predictor of morbidity and mortality outcomes.|3 months|||cells per cubic millimeter||Standard Deviation|Mean
709190|NCT00146757|Other Pre-specified|Investigator’s Clinical Assessment at Week 52 Compared With Baseline|The Investigator’s impression of the patient’s overall clinical status at Week 52 compared with Baseline.|Baseline to 52 weeks|The analysis was intent-to-treat.||participants|||Number
709191|NCT00146757|Other Pre-specified|Change From Baseline to Week 52 in Height|Change in Z-scores for standing height/lying-length-for-age from Baseline to Week 52. Z-score=number of standard deviations from mean. Z-scores greater than +2 and less than -2 are abnormal. A greater decrease in abnormally high z-score indicates a greater response.|Baseline to 52 weeks|The analysis was intent-to-treat.||Units on a scale||Standard Deviation|Mean
709192|NCT00146757|Other Pre-specified|Change From Baseline to Week 52 in Left Ventricular Mass (LVM) Z-Score|Change in LVM Z-scores as measured by echocardiography from Baseline to Week 52. Z-score=number of standard deviations from mean. Z-scores greater than +2 and less than -2 are abnormal. A greater decrease in abnormally high z-score indicates a greater response.|Baseline to 52 weeks|The analysis was intent-to-treat.||Units on a scale||Standard Deviation|Mean
709193|NCT00146757|Other Pre-specified|Expert Global Assessment of Sleep Study Results at Week 52 Compared With Baseline|Independent experts provided a global assessment for each sleep study visit as well as the degree of clinically meaningful change over the course of the study. Assessment was based on AHI, severity and frequency of oxygen desaturations and sleep quality.|Baseline to 52 weeks|The analysis was intent-to-treat.||participants|||Number
710820|NCT00168454|Secondary|Change in Number of Micturitions|Mean number of micturitions measured over a 7 day diary prior to each visit. Micturation is defined as urinating into the toilet.|Baseline, Week 2, Week 6, Week 12|Intent to Treat||micturitions|||Number
709194|NCT00146757|Other Pre-specified|Change From Baseline to Week 52 in Apnea/Hypopnea Index (AHI)|Number of absent (apnea) and shallow (hypopnea) breaths per hour of sleep. A greater decrease in events per hour indicates a greater response.|Baseline to 52 weeks|The analysis was intent-to-treat.||Events per hour||Standard Deviation|Mean
709195|NCT00146757|Other Pre-specified|Percent Change From Baseline to Week 52 in Liver Size (Hepatomegaly)|Percent change in extent of Liver Edge Below Right Costal Margin (BRCM) measured in centimeters from Baseline to Week 52; A greater decrease in percent change indicates a greater response.|Baseline to 52 weeks|The analysis was intent-to-treat.||Percentage of change||Standard Deviation|Mean
709196|NCT00146757|Other Pre-specified|Percent Change From Baseline to Week 52 in Urinary Glycosaminoglycan (uGAG) Level|Percentage change in the concentration of GAG relative to creatinine (ug GAG/mg creatinine) in urine from Baseline to Week 52; A greater decrease in percent change indicates a greater response.|Baseline to 52 weeks|The analysis was intent-to-treat.||Percentage of change||Standard Deviation|Mean
709197|NCT00146757|Primary|Pharmacokinetics - Volume of Distribution (Vz)|Vz is the volume that relates the amount of drug in the body after absorption is complete to the concentration of drug in the plasma.|52 weeks|The analysis was intent-to-treat.||liters/kilograms||Standard Deviation|Mean
709198|NCT00146757|Primary|Pharmacokinetics - Total Plasma Clearance (CL)|CL is volume of the body fluid cleared of the drug per unit of time.|52 weeks|The analysis was intent-to-treat.||(milliliters/minute)/kilograms||Standard Deviation|Mean
709199|NCT00146757|Primary|Pharmacokinetics - Elimination Half Life (t1/2)|Half-life is the time it takes for the concentration of drug in plasma to decline by 50%.|52 weeks|The analysis was intent-to-treat.||hours||Standard Deviation|Mean
709200|NCT00146757|Primary|Pharmacokinetics - Area Under the (Plasma Concentration-time) Curve (AUC∞)|AUC∞ is a measure of the total exposure to a drug.|52 weeks|The analysis was intent-to-treat.||hours units/milliliters||Standard Deviation|Mean
709201|NCT00146757|Primary|Safety Evaluation|Overall Safety Summary of Adverse Events (AEs) during Treatment Safety assessment was based on the incidence of AE reports.|52 weeks|The number of participants was determined as adequate to assess the safety of Aldurazyme in young children with mucopolysaccharidosis I (MPS I). The analysis was intent-to-treat.||participants|||Number
709202|NCT00146770|Other Pre-specified|Change From Baseline to Week 182 in Urinary GAG Level|Urinary Glycosaminoglycan (GAG) Levels: >> Concentration of GAG relative to creatinine in urine. A greater decrease in GAG level indicates a greater response.|Baseline to Week 182|The study enrolled patients who completed the Phase 3 double-blind study and wished to receive open-label treatment with Aldurazyme. The analysis method was intention to treat.||ug GAG/mg Creatinine||Standard Deviation|Mean
709203|NCT00146770|Secondary|Change From Baseline to Week 182 in Active Joint Range of Motion (ROM)|Active Joint Range of Motion (ROM): Shoulder Flexion Ability to maximally raise one’s arm overhead without assistance. Shoulder range of motion (mean of left and right arms) measured in degrees (0-180) by goniometry. Greater degree of flexion indicates greater response.|Baseline to Week182|The study enrolled patients who completed the Phase 3 double-blind study and wished to receive open-label treatment with Aldurazyme. The analysis method was intention to treat.||Degrees||Standard Deviation|Mean
709204|NCT00146770|Secondary|Change From Baseline to Week 182 in Child Health Assessment Questionnaire/Health Assessment Questionnaire (CHAQ/HAQ) Disability Index Score|CHAQ/HAQ = Patient questionnaire that measures the degree of disability on a scale of 0 (no disability) to 3 (maximal disability). A lower score indicates a greater response.|Baseline to Week 182|The study enrolled patients who completed the Phase 3 double-blind study and wished to receive open-label treatment with Aldurazyme. The analysis method was intention to treat.||Units on a scale||Standard Deviation|Mean
709205|NCT00146770|Secondary|Change From Baseline to Week 182 in Liver Volume|Liver Organ Volume: Volume of liver measured by Magnetic Resonance Imaging (MRI). Greater decrease in volume indicates a greater response.|Baseline to Week 182|The study enrolled patients who completed the Phase 3 double-blind study and wished to receive open-label treatment with Aldurazyme. The analysis method was intention to treat.||Cubic centimeters (cm3)||Standard Deviation|Mean
709206|NCT00146770|Secondary|Change From Baseline to Week 182 in Apnea/Hypopnea Index (AHI)|Apnea/Hypopnea Index (AHI): Number of absent (apnea) and shallow (hypopnea) breaths per hour of sleep. A greater decrease in events indicates a greater response.|Baseline to Week 182|The study enrolled patients who completed the Phase 3 double-blind study and wished to receive open-label treatment with Aldurazyme. The analysis method was intention to treat.||Events per Hour||Standard Deviation|Mean
709207|NCT00146770|Primary|Change From Baseline to Week 182 in Six Minute Walk Test (6MWT)|Six Minute Walk Test: Distance walked (measured in Meters) in 6 minutes. A longer distance indicates a greater response.|Baseline to Week 182|The study enrolled patients who completed the Phase 3 double-blind study and wished to receive open-label treatment with Aldurazyme. The analysis method was intention to treat with last value carried forward.||Meters||Standard Deviation|Mean
709208|NCT00146770|Primary|Change From Baseline to Week 182 in Percent Predicted Forced Vital Capacity (FVC)|Percent Predicted Forced Vital Capacity: the maximal exhaled breath volume following a maximal inhaled breath. Overall change from Baseline to Week 182 in percent predicted FVC = (observed value)/(predicted value) * 100%). A higher value indicates a greater response.|Baseline to Week 182|This study enrolled patients who completed the Phase 3 Double-Blind Study and wished to receive open-label treatment with Aldurazyme. The analysis method was intention to treat with last value carried forward.||percent predicted FVC||Standard Deviation|Mean
709209|NCT00146848|Secondary|Change in Self Assessed Physical Activity|Physical activity was assessed using the Physical Activity Scale of the Elderly (PASE) questionnaire for those patients with paired data available at the 6 week and 12 month visits. The PASE is designed to assess physical activity in older persons. The total PASE score was computed by multiplying the amount of time spent in each activity (hours/week) or participation (yes/no) in an activity by empirically derived item weights and summing over all activities. PASE scores for this study ranged from 0 to 756 with higher scores indicating more physical activity.|From randomization (6-weeks) through 12-month visit|Physical activity was assessed using the Physical Activity Scale for the Elderly and was analyzed for those patients with paired data available at the 6 week and 12 month visit. Patients were analyzed in their randomized groups. Postive values for changes denote improvements.||units on a scale||Standard Deviation|Mean
709210|NCT00146848|Primary|Clinical Composite Score|The primary outcome measure classified patients as improved, unchanged or worsened, based on a 4 components clinical composite score using the following four components: death, heart failure hospitalization, New York Heart Association [NYHA] class, patient's Global Assessment rating. Best value is improved, whereas worst value is worsened.|From randomization (6-weeks) through 12-month visit|This analysis is intention to treat (ITT) in terms of patient's being analyzed according to their randomized group. Last observation carried forward (LOCF) method was used for missing NYHA and global assessment measures at 12 months.||participants|||Number
709211|NCT00146848|Secondary|Change in Quality of Life|Quality of Life as assessed by the Minnesota Living with Heart Failure Questionniare for those patients with paired data at 6 weeks and 12 months. This score is on a scale of 0(best)- 105(worst). A negative change denotes improvement.|From randomization (6-weeks) through 12-month visit|Quality of Life was analyzed for those patients with paired data available at the 6 week and 12 month visit. Patients were analyzed in their randomized groups.||units on a scale||Standard Deviation|Mean
709212|NCT00147030|Secondary|Microcephaly|Head circumference at follow-up >2 standard deviations below the mean|18 months|Number of participants analyzed is reduced due to deaths prior to assessment and not all survivors could complete all elements of the examination. Number analyzed represents the participants on whom the relevant data for this outcome could be documented.||participants|||Number
709213|NCT00147030|Secondary|Epilepsy (Defined as Recurrent Seizures Beyond the Neonatal Period, Requiring Anticonvulsant Therapy at the Time of Assessment)||18 months|Number of participants analyzed is reduced due to deaths prior to assessment and not all survivors could complete all elements of the examination. Number analyzed represents the participants on whom the relevant data for this outcome could be documented.||participants|||Number
709214|NCT00147030|Secondary|Sensorineural Hearing Loss|Normal or near normal hearing, no sensorineural hearing loss|18 months|Number of participants analyzed is reduced due to deaths prior to assessment and not all survivors could complete all elements of the examination. Number analyzed represents the participants on whom the relevant data for this outcome could be documented.||participants|||Number
709215|NCT00147030|Secondary|Bayley Psychomotor Developmental Index Score (PDI)|Bayley Psychomotor Developmental Index score (PDI) <70|18 months|Number of participants analyzed is reduced due to deaths prior to assessment and not all survivors could complete all elements of the examination. Number analyzed represents the participants on whom the relevant data for this outcome could be documented.||participants|||Number
709216|NCT00147030|Secondary|Multiple Handicap|defined as the presence of any two of the following in an infant; neuromotor disability (Level 3-5 on Gross Motor Function classification), mental delay (Bayley Mental Developmental Index (MDI) score < 70), epilepsy, cortical visual impairment, sensorineural hearing loss|18 months|Number of participants analyzed is reduced due to deaths prior to assessment and not all survivors could complete all elements of the examination. Number analyzed represents the participants on whom the relevant data for this outcome could be documented.||participants|||Number
709217|NCT00147030|Secondary|Severe Neurodevelopmental Disability||18 months|Number of participants analyzed is reduced due to deaths prior to assessment and not all survivors could complete all elements of the examination. Number analyzed represents the participants on whom the relevant data for this outcome could be documented.||participants|||Number
709218|NCT00147030|Secondary|Mortality||18 months|||participants|||Number
709219|NCT00147030|Secondary|Duration of Hospitalisation|Total duration of hospital care|Duration of hospital stay, on average 22 days|||days||Inter-Quartile Range|Median
709220|NCT00147030|Secondary|Pulmonary Airleak||Duration of hospital stay, on average 22 days|||participants|||Number
709221|NCT00147030|Secondary|Pneumonia||Before discharge from hospital|||participants|||Number
709222|NCT00147030|Secondary|Renal Failure Treated With Dialysis||Duration of hospital stay, on average 22 days|||participants|||Number
709223|NCT00147030|Secondary|Major Venous Thrombosis||Duration of hospital stay, on average 22 days|||participants|||Number
709224|NCT00147030|Secondary|Thrombocytopenia||Duration of hospital stay, on average 22 days|||participants|||Number
709225|NCT00147030|Secondary|Cardiac Arrhythmia|Arrhythmia identified on electrocardiogram (ECG), e.g. sinus bradycardia <80 beats per minute, ventricular arrhythmia.|Duration of hospital stay, on average 22 days|||participants|||Number
709226|NCT00147030|Secondary|Necrotising Enterocolitis||Duration of hospital stay, on average 22 days|||participants|||Number
709227|NCT00147030|Secondary|Culture Proven Sepsis||Duration of hospital stay, on average 22 days|||participants|||Number
709228|NCT00147030|Secondary|Prolonged Blood Coagulation Time||Duration of hospital stay, on average 22 days|||participants|||Number
709229|NCT00147030|Secondary|Pulmonary Hypertension||Duration of hospital stay, on average 22 days|||participants|||Number
709230|NCT00147030|Secondary|Pulmonary Haemorrhage||Duration of hospital stay, on average 22 days|||participants|||Number
709231|NCT00147030|Secondary|Persistent Hypotension|Hypotension was defined as a mean blood pressure of 40 mm Hg or less and was persistent if causes of hypotension had been sought and appropriate treatment provided, without success.|Duration of hospital stay, on average 22 days|||participants|||Number
709232|NCT00147030|Secondary|Intracranial Haemorrhage|Intracranial hemorrhage was identified on magnetic resonance imaging (MRI).|Duration of hospital stay, on average 22 days|||participants|||Number
709233|NCT00147030|Primary|Combined Incidence of Mortality and Severe Neurodevelopmental Disability in Survivors|Severe neurodevelopmental disability was defined as a score of less than 70 on the Mental Developmental Index of the Bayley Scales of Infant Development II (BSID-II) (on which the standardization mean [± standard deviation (SD)] is 100±15 and higher scores indicate better performance), a score of 3 to 5 on the Gross Motor Function Classification System (GMFCS) (on which scores can range from 1 to 5, with higher scores indicating greater impairment), or bilateral cortical visual impairment with no useful vision.|18 months|||participants|||Number
709234|NCT00147199|Secondary|N-terminal Pro-B-Type Natriuretic Peptide (NT Pro-BNP)|Change in NT pro-BNP from Baseline to Week 12. Plasma samples were collected from patients at Baseline and Week 12 in order to measure any change over time in circulating plasma levels of this biomarker.|12 weeks|Per protocol||pg/mL||Inter-Quartile Range|Median
709235|NCT00147199|Secondary|Change in Signs and Symptoms of PAH|Signs and symptoms of PAH (Loud P2 sound, Ascites, Right ventricular S3 sound, Dyspnea, Right ventricular S4 sound, Orthopnea, Right ventricular heave, Dizziness, Murmur of tricuspid insufficiency, Syncope, Murmur of pulmonic insufficiency, Chest pain, Hepatomegaly, Palpitations, Jugular venous distension at 45 degrees, Fatigue, Edema) were assessed at Baseline and Week 12. The status of each sign and symptom (“absent” or “present”) was assessed at each visit. To assess overall change from baseline in signs and symptoms, a “1” was assigned for each sign and symptom that was “present” at the Week 12 but was “absent” at baseline, a “-1” was assigned for each sign and symptom that was “absent” at Week 12 but was “present” at baseline, and a “0” was assigned for no change. An overall change score at each post-baseline assessment was then calculated by summing these values for all signs and symptoms. The overall change score had the potential to range from -17 to 17.|12 weeks|Intention to treat population.||units on a scale||Full Range|Median
709236|NCT00147199|Secondary|Quality of Life (Minnesota Living With Heart Failure)|Quality of life as measured by the Minnesota Living With Heart Failure (MLWHF) questionnaire was evaluated at baseline and at Week 12. The MLWHF questionnaire consists of 21 questions assessing how the patient’s heart failure has prevented them from living the way they wanted during the defined time period. Each question was graded by the patient with a numeric value between 0 (No/none) and 5 (very much). These scores were then summed across the 21 questions for a Global Score. Global scores ranged from 0 to 105. These questions were further grouped into Physical (8 of the questions) and Emotional (5 of the questions) dimensions to further characterize the effect of heart failure on the patient’s life. Physical scores ranged from 0 to 40, and emotional scores ranged from 0 to 25. For all 3 categories, the lower the score, the better the outcome. Values presented as change from Baseline.|12 weeks|Intention to treat population.||units on a scale||Inter-Quartile Range|Median
709237|NCT00147199|Secondary|Peak 6MWD at Week 6|Change in peak 6MWD between Baseline and Week 6.|6 weeks|Intention to treat||meters||Inter-Quartile Range|Median
709238|NCT00147199|Secondary|Trough 6MWD at Week 12|Change in 6MWD from Baseline to trough 6MWD at Week 12. Trough was defined as a 6MWT conducted at least 4 hours following study drug inhalation.|12 Weeks|Intention to treat population||meters||Inter-Quartile Range|Median
709239|NCT00147199|Secondary|New York Heart Association (NYHA) Functional Classification|"Change in NYHA functional class at Week 12. NYHA classifications:
Class I – Patients with pulmonary hypertension but without resulting limitation of physical activity. Ordinary physical activity does not cause undue dyspnea or fatigue, chest pain or near syncope.
Class II – Patients with pulmonary hypertension resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity causes undue dyspnea or fatigue, chest pain or near syncope.
Class III – Patients with pulmonary hypertension resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes undue dyspnea or fatigue, chest pain or near syncope.
Class IV – Patients with pulmonary hypertension in the inability to carry out any physical activity without symptoms. These patients manifest signs of right heart failure. Dyspnea and/or fatigue may even be present at rest. Discomfort is increased by any physical activity."|12 weeks|Intention to treat population||participants|||Number
709240|NCT00147199|Secondary|Borg Dyspnea Score|The Borg dyspnea score is a patient reported number between 0 (no perceived shortness of breath) and 10 (maximum perceived shortness of breath), obtained at the completion of each 6MWT.|12 weeks|Intention to treat population. A Week 12 observation was not present for one subject and that data point is not included in the analysis.||score||Standard Deviation|Mean
709241|NCT00147199|Secondary|Clinical Worsening Events|Clinical worsening was defined as the first incidence of clinical worsening from randomization to the first occurrence of death, transplantation, hospitalization for PAH, or initiation of additional approved PAH therapy.|12 weeks|Intention to treat population||clinical worsening events|||Number
709242|NCT00147199|Primary|Peak 6-minute Walk Distance|Change in peak 6-minute walk distance from baseline to Week 12. Peak 6MWD was defined as a 6-minute walk test (6MWT) within 10 to 60 minutes after study drug inhalation|12 weeks|Intention to treat analysis||meters||Inter-Quartile Range|Median
709243|NCT00147212|Primary|The Number of Men With Advanced Prostate Cancer Treated With Trabectedin Who Have a PSA Response|Prostate specific antigen (PSA) response rate, as defined by the PSA Working Group Criteria (see Bubley et al, J Clin Oncol. 1999 Nov;17(11):3461-7)|Participants were followed until disease progression, an average of 6 months|Intent to treat||participants|||Number
709244|NCT00147225|Primary|Number of Participants With Venous Thromboembolism (VTE) Related Serious Adverse Events in Sequential Cohort Dose Escalation Study of AMG 531 Following Chemotherapy|Number of participants experiencing an venous thromboembolism (VTE) related serious adverse event (SAE) during study treatment, possible or probable related to study drug. All toxicities graded using the Common Terminology Criteria for Adverse Events version 3.0. Participation has a maximum of 6 cycles of chemotherapy on the study. VTE events reported are part or whole total number reported for study SAEs, not in addition to SAEs reported.|Toxicity assessments with each dose level/cycle (21-28 day cycle) up to 6 cycles|All participants who received treatment were evaluable for toxicity; therefore 51 participants who received at least one dose of the study drug were evaluable for toxicity.||participants|||Number
709245|NCT00147225|Primary|Number of Participants With Adverse Events in Sequential Cohort Dose Escalation Study of AMG 531 Following Chemotherapy|Number of participants experiencing an adverse event (AE) or serious adverse event (SAE) during study treatment, possible or probable related to study drug. All toxicities graded using the Common Terminology Criteria for Adverse Events version 3.0. Participation has a maximum of 6 cycles of chemotherapy on the study.|Toxicity assessments with each dose level/cycle (21-28 day cycle) up to 6 cycles|All participants who received treatment were evaluable for toxicity; therefore 51 participants who received at least one dose of the study drug were evaluable for toxicity.||participants|||Number
709246|NCT00147238|Primary|Sensitivity of MRI Per Patient|Sensitivity of MRI on a per patient basis using two-sided McNemar test to detect differences in the sensitivities of two paired MR images (one with and one without ferumoxtran-10 contrast agent). Sensitivity of images written as percentage in decimal form: 0.0 (low) to 1.0 (high).|MRI without ferumoxtran-10 contrast and second repeated MRI with contrast agent within 24-36 hours of contrast injection, about 24 hours after first MRI|Primary outcome measure was not assessed due to early study termination (e.g. patients did not receive assigned treatment).|||||
709247|NCT00147277|Secondary|Evaluate Different Possible Predictors of ATP Success||one year||||||
709252|NCT00147277|Primary|Efficacy of Anti Tachycardia Pacing (ATP) Therapy to Terminate Fast Ventricular Tachycardia (With Cycle Length of 240ms-320msec)|Termination of Ventricular Tachycardia is calculated as percentage of successfully terminated episodes, adjusted for multiple events with (GEE) method. This technique yields an average therapy efficacy and 95% CI that is based on number of patients, number of episodes per patient, and magnitude of the correlation between responses within patients.|one year|934 patients were created in the electronic data capture system, only 925 patients were enrolled in the study: 4 patients in the 8 pulses arm and 5 patients in the 15 pulses arm were created by mistake and excluded from analysis. The analysis were performed with the Intention To Treat (ITT) method.||Percentage of FVT episodes terminated|||Number
709253|NCT00147290|Secondary|Determine the Rate of Both FVT and VT Episodes Which Are Accelerated or Degenerates Into VF||one year||||||
709254|NCT00147290|Secondary|Compare Efficacy of BiV and RV ATP (All ATP Therapies) to Terminate Slow VT||one year||||||
709255|NCT00147290|Secondary|Compare Efficacy of the First BiV and RV ATP to Terminate Slow VT||one year||||||
709256|NCT00147290|Secondary|Compare Efficacy of the First BiV and RV ATP to Terminate FVT||one year||||||
709257|NCT00147290|Primary|Efficacy of Anti Tachycardia Pacing (ATP) Therapy (Burst, 8 Pulses, 88 %, 1 Sequence) to Terminate All Types of Ventricular Tachycardia.|Termination of Ventricular Tachycardia is calculated as percentage of successfully terminated episodes, adjusted for multiple events with GEE method. This technique yields an average therapy efficacy and 95% CI that is based on number of patients, number of episodes per patient, and magnitude of the correlation between responses within patients.|one year|||Percent of VT episodes terminated|||Number
709258|NCT00147316|Primary|Number of Patients With Symptomatic Intracranial Hemorrhage (sICH) Within 36 Hours|The number of patients with sICH|within 36 hours|||participants|||Number
709259|NCT00147316|Primary|Number of Patients With a Modified Rankin Scale (mRS) Score of 0-1 at 3 Months|The number of patients with a mRS score of 0-1. The mRS has 6 items, where 0 = No symptoms at all, 1 = No significant disability despite symptoms, 2 = Slight disability, 3 = Moderate disability, 4 = Moderately severe disability, 5 = Severe disability. The higher scores reflect increased disability.|at 3 months|||participants|||Number
709260|NCT00147446|Secondary|No.of New or Enlarged T2 Lesions From Week 8 to Week 24|T2-weighted MRI is commonly used in phase II trials to identify more permanent lesions. The single value was calculated by summing up the lesions from week 8 to week 24.|week 8 to week 24|||participants|||Number
709261|NCT00147446|Primary|No.of Gd+ Lesions From Week 8 to Week 24|Gd+ is Gadolinium-enhancing MRI brain lesion, A marker of the opening of the blood-brain barrier and is typically used as a primary endpoints in phase II trials because of its high sensitivity to ongoing MS disease activity and its association with clinical exacerbation. The single value was calculated by summing up the lesions from week 8 to week 24.|week 8 to week 24|A total of 121 patients with relapsing forms of MS were randomized to SMT-MS or WLC. Participants were enrolled at MS specialty clinics at 3 sites in the United States (UCSF; Evergreen Hospital Medical Center, and the Feinberg School of Medicine at Northwestern University, Chicago, Illinois) and through local chapters of the National MS Society.||participants|||Number
709262|NCT00147498|Secondary|Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)|Disease improvement was classified as good, moderate, and no change based on improvement in DAS 28-3 (CRP) from baseline and present DAS 28-3 (CRP) score. Good: an improvement from baseline of >1.2 and a present score of <=3.2; none: an improvement of <=0.6 or >0.6 to <=1.2 with a present score of >5.1; remaining participants were classified as having moderate improvement. Scores of good and moderate were considered to have therapeutic response.|Baseline, Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.||participants|||Number
709263|NCT00147498|Secondary|Change From Baseline in Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 1, 2, 4, 6, and 8|DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score ranging 0 to 9.4; higher scores indicated greater affectation due to disease activity. DAS 28-3 (CRP) <=3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and <2.6 = remission.|Baseline, Week 1, 2, 4, 6, and 8|FAS included all participants who were randomized to study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable for a particular time-point for each treatment arm, respectively.||units on a scale||Standard Deviation|Mean
709264|NCT00147498|Secondary|Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])|DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score ranging 0 to 9.4; higher scores indicated greater affectation due to disease activity. DAS 28-3 (CRP) less than or equal to (<=) 3.2 implied low disease activity and greater than (>) 3.2 to 5.1 implied moderate to high disease activity, and less than (<) 2.6 = remission.|Baseline, Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
709265|NCT00147498|Secondary|Change From Baseline in C-Reactive Protein (CRP) at Week 1, 2, 4, 6 and 8|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is 0 mg/L to 100 mg/L. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.||mg/L||Standard Deviation|Mean
709299|NCT00147537|Secondary|Accumulation of CP-751,871 Ratio (Cycle 4 AUC504 / Cycle 1 AUC504) (Rac) in Phase 1b|Accumulation ratio (Cycle 4 AUC504 / Cycle 1 AUC504) (Rac)|Cycle 1 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 2 pre-infusion (which is the end of Cycle 1). Cycle 4 pre-infusion, 1 and 24 hour and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4).|All participants who received at least one dose of each agent. N=number of participants contributing to the summary statistics||ratio||Standard Deviation|Mean
709266|NCT00147498|Secondary|C-Reactive Protein (CRP)|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is 0 milligram per liter (mg/L) to 100 mg/L. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.||mg/L||Standard Deviation|Mean
709267|NCT00147498|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 1, 2, 4, 6 and 8|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Error|Mean
709268|NCT00147498|Secondary|Health Assessment Questionnaire-Disability Index (HAQ-DI)|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Error|Mean
709269|NCT00147498|Secondary|Change From Baseline in Patient Assessment of Arthritis Pain at Week 1, 2, 4, 6 and 8|Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.|Baseline, Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.||mm||Standard Error|Mean
709270|NCT00147498|Secondary|Patient Assessment of Arthritis Pain|Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.|Baseline, Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.||mm||Standard Error|Mean
709271|NCT00147498|Secondary|Change From Baseline in Physician Global Assessment of Arthritis at Week 1, 2, 4, 6 and 8|Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.|Baseline, Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.||mm||Standard Error|Mean
709272|NCT00147498|Secondary|Physician Global Assessment of Arthritis|Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.|Baseline, Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.||mm||Standard Error|Mean
709273|NCT00147498|Secondary|Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 1, 2, 4, 6 and 8|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly."|Baseline, Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.||mm||Standard Error|Mean
709274|NCT00147498|Secondary|Patient Global Assessment (PtGA) of Arthritis|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 millimeter (mm) Visual Analog Scale (VAS) where 0 mm = very well and 100 mm = very poorly."|Baseline, Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.||mm||Standard Error|Mean
709275|NCT00147498|Secondary|Change From Baseline in Swollen Joints Count (SJC) at Week 1, 2, 4, 6 and 8|Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1. A negative value in change from baseline indicates an improvement.|Baseline, Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.||swollen joints||Standard Error|Mean
709300|NCT00147537|Secondary|CP-751,871 Concentration at 504 Hours Post Dose(C504) for Cycle 4 (End of the 21-day Cycle) in Phase 1b|Concentration at 504 hours post dose|Cycle 5 pre-infusion (which is the end of Cycle 4)|All participants who received at least one dose of each agent. N=number of participants contributing to the summary statistics||mg/L||Standard Deviation|Mean
709276|NCT00147498|Secondary|Swollen Joints Count (SJC)|Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1.|Baseline, Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.||swollen joints||Standard Error|Mean
709277|NCT00147498|Secondary|Change From Baseline in Tender Joints Count (TJC) at Week 1, 2, 4, 6 and 8|Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1. A negative value in change from baseline indicated an improvement.|Baseline, Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.||tender joints||Standard Error|Mean
709278|NCT00147498|Secondary|Tender Joints Count (TJC)|Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.|Baseline, Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.||tender joints||Standard Error|Mean
709279|NCT00147498|Secondary|Area Under the Numeric Index of American College of Rheumatology Response (ACR-n) Curve|ACR-n: calculated by taking the lowest percentage improvement in (1) SJC or (2) TJC or (3) the median of the remaining 5 components of the ACR response (participant’s assessment of disease activity; participant’s global assessment of pain; physician’s assessment of disease activity; participant’s assessment of physical function; an acute phase reactant value - CRP). Negative numbers indicate worsening. The area under the curve (AUC) for ACR-n is the measure of the AUC of the mean change from baseline in ACR-n. The trapezoidal rule was used to compute the AUC.|Baseline up to Week 6|FAS included all randomized participants who received at least 1 dose of study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure.||units on a scale*weeks||Standard Deviation|Mean
709280|NCT00147498|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response|ACR70 response: >= 70% improvement in TJC or SJC and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Missing data were imputed using Last Observation Carried Forward (LOCF) at Week 1, 2, 4, and 6. Here ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.||percentage of participants|||Number
709281|NCT00147498|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response|ACR50 response: >= 50% improvement in TJC or SJC and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Missing data were imputed using Last Observation Carried Forward (LOCF) at Week 1, 2, 4, and 6. Here ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.||percentage of participants|||Number
709282|NCT00147498|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response|ACR20 response: >=20% improvement in TJC; >= 20% improvement in SJC; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 1, 2, 4, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Missing data were imputed using Last Observation Carried Forward (LOCF) at Week 1, 2, and 4. Here ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.||percentage of participants|||Number
709283|NCT00147498|Primary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 6|ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joints count (TJC); >= 20% improvement in swollen joints count (SJC); and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Week 6|Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study treatment.||percentage of participants|||Number
709284|NCT00147537|Secondary|Duration of Response (DR) in Phase 2|Time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.44. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Every 2 cycles (7 to 10 days prior to the planned start of the next cycle, each cycle was 21 days) from start of treatment until either death or a total of 2 years from the date of randomization|Due to the status of the program, duration of response was not analyzed.|||||
709285|NCT00147537|Secondary|Time to Progression (TTP) in Phase 2|Time in months from start of study treatment to first documentation of objective tumor progression. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.44. Tumor progression was determined from radiological image (where data meet the criteria for progressive disease [PD]).|Every 2 cycles (7 to 10 days prior to the planned start of the next cycle, each cycle was 21 days) from start of treatment until either death or a total of 2 years from the date of randomization|Due to the status of the program, time to progression was not was not analyzed.|||||
709286|NCT00147537|Secondary|Progression-Free Survival (PFS): Phase 2|Time in months from start of study treatment to first documentation of objective tumor progression or death due to any cause whichever comes first. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.44. Tumor progression was determined from radiological image (where data meet the criteria for progressive disease [PD]).|Every 2 cycles (7 to 10 days prior to the planned start of the next cycle, each cycle was 21 days) from start of treatment until either death or a total of 2 years from the date of randomization|All participants who received any of the study treatments.||months||90% Confidence Interval|Median
709287|NCT00147537|Secondary|Maximum Observed Plasma CP-751,871 Concentration (Cmax) for Cycle 4 in Phase 2|Maximum Observed Plasma Concentration|Cycle 4 pre-infusion, 1 and 24 hour and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4).|Cmax was not calculated for Cycle 4 in Phase 2 based on the status of the program and the limited value this further PK analyses would provide.|||||
709288|NCT00147537|Secondary|CP-751,871 Concentration at 504 Hours Post Dose(C504) for Cycle 4 (End of the 21-day Cycle) in Phase 2|Concentration at 504 hours post dose|Cycle 4 pre-infusion, 1 and 24 hour and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4).|C504 was not calculated for Cycle 4 in Phase 2 based on the status of the program and the limited value this further PK analyses would provide.|||||
709289|NCT00147537|Secondary|Area Under the Curve From Time Zero to 504 Hours [AUC (0-504)] Post Infusion of CP-751,871 for Cycle 4 in Phase 2|AUC (0-504)= Area under the plasma concentration versus time curve from time zero (pre-dose) to the end of the 21-day cycle, 504 hours(0-504)|Cycle 4 pre-infusion, 1 and 24 hour and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4).|AUC504 was not calculated for Cycle 4 in Phase 2 based on the status of the program and the limited value this further PK analyses would provide.|||||
709290|NCT00147537|Secondary|Clearance (CL) of CP-751,871 for Cycle 4 in Phase 2|Systemic clearance.|Cycle 4 pre-infusion, 1 and 24 hour and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4).|Clearance (CL) were not calculated based on the status of the program and the limited value this further PK analyses would provide.|||||
709291|NCT00147537|Secondary|Apparent Volume of CP-751,871 Distribution (Vd) for Cycle 4 in Phase 2|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|Cycle 4 pre-infusion, 1 and 24 hour and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4)|Volume of distribution (Vd) was not calculated based on the status of the program and the limited value this further pharmacokinetic analyses would provide.|||||
709292|NCT00147537|Secondary|The European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC-QLQ-C30/-LC13) in Phase 2|The QLQ-C30/-LC13 is a 43 item, self-administered questionnaire designed to assess health outcomes in clinical trials. In addition to global quality of life, the measure assesses 5 functional domains (physical, role, cognitive, emotional and social functioning) and specific symptoms (eg, nausea, pain). Each item is rated on a 1-4 scale with ‘1’ representing “not at all” and ‘4’ “very much”. Within domains, items are scored to obtain a total score with higher scores representative of poorer HRQoL. Scale score range: 0 to 100.|Day 1 pre-dose of Cycle 1, monthly prior to each cycle (up to 17 cycles, each cycle was 21 day), and follow up (one year post last study dose)|Due to the status of the program, no participants were analyzed for EORTC-QLQ-C30/-LC13 in phase 2.|||||
709293|NCT00147537|Secondary|M.D. Anderson Symptom Assessment Inventory (MDASI) in Phase 2|The MDASI is a 19-item questionnaire that assesses the severity of 13 symptoms over the past 24 hours, as well as how much the symptoms interfered with 6 areas of function (eg, walking, work, mood), when the symptom was “at its worst”. Each item is scored from 0 to 10, with ‘0’ indicating that the symptom was either not present or did not interfere with their activities, and ‘10’ indicating that the symptom was “as bad as you can imagine” or “interfered completely” with their life. Total average score range: 0 to 10.|Day 1 pre-dose of Cycle 1, weekly for Cycle 1 and 2, monthly prior to each subsequent cycle (Cycle 3 up to Cycle 17, each cycle was 21 day), and follow up (one year post last study dose)|Due to the status of the program, no participants were analyzed for MDASI in phase 2.|||||
709294|NCT00147537|Secondary|Number of Participants With Positive Human Anti-human Antibody (HAHA) Values: Phase 2|HAHA are indicators of immunogenicity to CP-751,871|Day 1 pre-infusion of each Cycle (each cycle was 21 day) up to Cycle 17 and 150 days after the last CP-751,871 infusion|All participants who received any of the study treatments. N=number of participants who were analyzed for HAHA||number of participants|||Number
709295|NCT00147537|Secondary|Maximum Observed Plasma CP-751,871 Concentration (Cmax) for Cycle 4 in Phase 1b|Maximum Observed Plasma Concentration|Cycle 4 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is then end of Cycle 4)|All participants who received at least one dose of each agent. N=number of participants contributing to the summary statistics||mg/L||Standard Deviation|Mean
709296|NCT00147537|Secondary|Maximum Observed Plasma CP-751,871 Concentration (Cmax) for Cycle 1 in Phase 1b|Maximum Observed Plasma Concentration|Cycle 1 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 2 pre-infusion (which is the end of Cycle 1)|All participants who received at least one dose of each agent. N=number of participants contributing to the summary statistics||mg/L||Standard Deviation|Mean
709297|NCT00147537|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration of CP-751,871 (AUClast) for Cycle 4 in Phase 1b|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|Cycle 4 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4)|All participants who received at least one dose of each agent. N=number of participants contributing to the summary statistics||mg.hr/L||Standard Deviation|Mean
709298|NCT00147537|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration of CP-751,871(AUClast) for Cycle 1 in Phase 1b|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|Cycle 1 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 2 pre-infusion (which is the end of Cycle 1)|All participants who received at least one dose of each agent. N=number of participants contributing to the summary statistics||mg.hr/L||Standard Deviation|Mean
709425|NCT00141102|Secondary|Change From Baseline in Hematocrit at Month 6/ET||Month 6/ET|Safety population. Number of Participants Analyzed = number of subjects with analyzable data.||percent||Standard Error|Least Squares Mean
709301|NCT00147537|Secondary|CP-751,871 Concentration at 504 Hours Post Dose (C504) for Cycle 1 (End of the 21-day Cycle) in Phase 1b|Concentration at 504 hours post dose|Cycle 2 pre-infusion (which is the end of Cycle 1)|All participants who received at least one dose of each agent. N=number of participants contributing to the summary statistics||mg/L||Standard Deviation|Mean
709302|NCT00147537|Secondary|Plasma Decay Half-Life (t1/2) of CP-751,871 for Cycle 4 in Phase 1b|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Cycle 4 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4)|All participants who received at least one dose of each agent. N=number of participants contributing to the summary statistics||Day||Standard Deviation|Median
709303|NCT00147537|Secondary|Plasma Decay Half-Life (t1/2) of CP-751,871 for Cycle 1 in Phase 1b|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Cycle 1 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 2 pre-infusion (which is the end of Cycle 1)|All participants who received at least one dose of each agent. N=number of participants contributing to the summary statistics||Day||Standard Deviation|Mean
709304|NCT00147537|Secondary|Area Under the Curve From Time Zero Extrapolated to Infinite Time [AUCinf] for CP-751,871 for Cycle 1 in Phase 1b|AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) extrapolated to infinite time.|Cycle 1 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 2 pre-infusion (which is the end of Cycle 1)|All participants who received at least one dose of each agent. N=number of participants contributing to the summary statistics||mg.hr/L||Standard Deviation|Mean
709305|NCT00147537|Secondary|Area Under the Curve From Time Zero to 504 Hours [AUC (0-504)] Post Infusion of CP-751,871 for Cycle 4 in Phase 1b|AUC (0-504)= Area under the plasma concentration versus time curve from time zero (pre-dose) to the end of the 21-day cycle, 504 hours(0-504)|Cycle 4 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4)|All participants who received at least one dose of each agent. N=number of participants contributing to the summary statistics||mg.hr/L||Standard Deviation|Mean
709306|NCT00147537|Secondary|Area Under the Curve From Time Zero to 504 Hours [AUC (0-504)] Post Infusion of CP-751,871 for Cycle 1 in Phase 1b|AUC (0-504)= Area under the plasma concentration versus time curve from time zero (pre-dose) to the end of the 21-day cycle, 504 hours(0-504)|Cycle 1 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 2 pre-infusion (which is the end of Cycle 1)|All participants who received at least one dose of each agent. N=number of participants contributing to the summary statistics||milligram.hour/Liter (mg.hr/L)||Standard Deviation|Mean
709307|NCT00147537|Secondary|Plasma Concentration of CP-751,871 at the End of Infusion (Cendinf) for Cycle 4 in Phase 1b||Cycle 4 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4)|All participants who received at least one dose of each agent. N=number of participants contributing to the summary statistics||mg/L||Standard Deviation|Mean
709308|NCT00147537|Secondary|Plasma Concentration of CP-751,871 at the End of Infusion (Cendinf) for Cycle 1 in Phase 1b||Cycle 1 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 2 pre-infusion (which is the end of Cycle 1)|All participants who received at least one dose of each agent. N=number of participants contributing to the summary statistics||milligram/liter (mg/L)||Standard Deviation|Mean
709309|NCT00147537|Secondary|Number of Circulating Tumor-Related Cells (CTCs) and CTC Insulin-Like Growth Factor 1 Receptor (IGF-IR) Expression: Phase 1b|Blood samples were collected to enumerate the number of total CTCs and CTC insulin-like growth factor 1 receptor (IGF-IR) expression|Day 1 pre-dose and Days 15 to 21 of Cycle 4|Per protocol amendment 6, blood samples for the rapid quantification of CTCs were no longer collected from participants enrolled in the study. Insufficient data were available to evaluate for correlation.|||||
709310|NCT00147537|Secondary|Number of Circulating Endothelial Cells (CECs): Phase 1b||Day 1 pre-dose and Days 15 to 21 of Cycle 4|Per protocol amendment 6, blood samples for the rapid quantification of CECs were no longer collected from participants enrolled in the study. Insufficient data were available to evaluate for correlation.|||||
709311|NCT00147537|Secondary|Number of Participants With Positive Human Anti-human Antibody (HAHA) Values: Phase 1b|HAHA are indicators of immunogenicity to CP-751,871.|Day 1 pre-infusion of each cycle up to Cycle 17 (each cycle was 21 day), 150 days after the last CP-751,871 infusion, and last follow up visit (one year post last study dose)|All participants who received at least one dose of any agent. N=number of participants who were analyzed for HAHA||number of participants|||Number
709312|NCT00147537|Secondary|Objective Response Rate: Phase 1b|Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumor (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.|Every 2 cycles (7 to 10 days prior to the planned start of the next cycle, each cycle was 21 days) from start of treatment until either death or a total of 2 years from the date of randomization|All participants who received at least one dose of any agent. N=number of participants who had measurable disease at baseline and an adequate baseline tumor assessment||percentage of participants|||Number
709313|NCT00147537|Primary|Objective Response Rate in Non-Adenocarcinoma Participants: Phase 2|Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumor (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.|Every 2 cycles (7 to 10 days prior to the planned start of the next cycle, each cycle was 21 days) from start of treatment until either death or a total of 2 years from the date of randomization|All participants who received any of the study treatments. N=number of participants who had measurable disease at baseline and an adequate baseline tumor assessment||percentage of participants||90% Confidence Interval|Number
709426|NCT00141102|Secondary|Change From Baseline in Hemoglobin at Month 6/ET||Month 6/ET|Safety population = all randomized subjects who received at least 1 dose of study medication. Number of Participants Analyzed = number of subjects with analyzable data.||grams (g)/deciliter (dL)||Standard Error|Least Squares Mean
709314|NCT00147537|Primary|Objective Response Rate: Phase 2|Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumor (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.|Every 2 cycles (7 to 10 days prior to the planned start of the next cycle, each cycle was 21 days) from start of treatment until either death or a total of 2 years from the date of randomization|All participants who received any of the study treatments. N=number of participants who had measurable disease at baseline and an adequate baseline tumor assessment||percentage of participants||90% Confidence Interval|Number
709315|NCT00147537|Primary|Recommended Phase 2 Dose (RP2D): Phase 1b||Start of treatment (baseline) up to the end of Cycle 1 (Day 21)|All participants who received at least one dose of any agent.||mg/kg|||Number
709316|NCT00147537|Primary|Maximum Tolerated Dose (MTD)of CP-751,871 in Combination With Paclitaxel and Carboplatin: Phase 1b|The maximum tolerated dose of CP-751,871 in combination with paclitaxel and carboplatin is the highest dose level below the Maximum Administered Dose (the dose level at which 2 or more out of 3 to 6 patients experience a Dose Limiting Toxicity at a dose level in Cycle 1) at which none or one out of 6 patients experience a Cycle 1 Dose Limiting Toxicity.|Start of treatment (baseline) up to the end of Cycle 1 (Day 21)|All participants who received at least one dose of any agent.||mg/kg|||Number
709317|NCT00147745|Primary|Acute Effect of a Single Dose of Colesevelam on Oral Glucose Absorption From Baseline to First Dose|Change in area under the curve for glucose (AUCg) after a glucose tolerance test. A decrease in AUCg is indicative of a drug effect.|Baseline (Day -4) to first dose (Day 1)|The entire study population was included in this analysis||mg*hr/dL||Standard Deviation|Mean
709318|NCT00147745|Secondary|Change in Hemoglobin A1C Due to Effect of Colesevelam From Baseline to 12 Weeks|The parameter measured is the percent of hemoglobin A that is glycosylated. A decrease in this parameter is indicative of improved glucose control.|Baseline to 12 weeks|"One participant in the colesevelam 3.8g group discontinued. Therefore, 15 participants were included in this analysis.
The least squares mean is adjusted for baseline values. This corrects for differences in baseline values between treatment groups."||percent||Standard Error|Least Squares Mean
709319|NCT00147745|Secondary|The Acute Effect of Colesevelam (Multiple Doses) on Oral Glucose Absorption From Baseline to 12 Weeks|The parameter measured is the change in area under the curve for glucose(AUCg) after an oral glucose tolerance test. A decrease in AUCg indicative of drug effect on glucose absorption.|Baseline to 12 weeks|One participant in the colesevelam 3.8g group discontinued. Therefore, 15 participants were included in this analysis.||mg*hr/dL||Standard Error|Least Squares Mean
709320|NCT00147745|Primary|Difference in Endogenous (Hepatic) Glucose Output During a Low-dose Insulin Infusion From Baseline to Week 12.|The parameter measured is the endogenous (hepatic) glucose output during a low-dose insulin infusion. A decrease is indicative of greater senstitivity of the liver to insulin.|Baseline to 12 weeks|The population analyzed was all randomized subjects who received medication and had a baseline and at least 1 post-randomization assessment of an efficacy variable. One placebo participant did not have a valid post-randomization insulin clamp study. Therefore, the number included in the placebo group for this analysis was 13.||mg/kg/min||Standard Error|Least Squares Mean
709321|NCT00147745|Primary|Difference in Endogenous (Hepatic) Glucose Output During a High-dose Insulin Infusion From Baseline to After 12 Weeks of Treatment.|The parameter measured is the endogenous (hepatic) glucose output during a high-dose insulin infusion. A decrease after treatment with colesevelam is indicative of greater sensitivity of the liver to insulin.|Baseline to 12 weeks|The population analyzed was all randomized subjects who received medication and had a baseline and at least 1 post-randomization assessment of an efficacy variable. One placebo participant did not have a valid post-randomization insulin clamp study. Therefore, the number included in the placebo group for this analysis was 13.||mg/kg/min||Standard Error|Least Squares Mean
709322|NCT00147823|Other Pre-specified|Bone Trabeculation Through the Defect (BT) Compared at 6 Weeks|Bone trabeculation through the bone lesion compared at 6 weeks were reviewed with radiographs. There were several participants with incomplete follow up or incomplete radiographs.|6 weeks|Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs taken at this time point.||percentage of trabeculation||Full Range|Mean
709323|NCT00147823|Other Pre-specified|Resorption of Graft Material (GR) Compared at 6 Weeks|Percentage of graft material that is resorbed (disappears) from area of incorporation at 6 weeks. Participants were seen 6 week follow with radiographs to review resorption of graft material. There a several that had incomplete follow up or radiographs not taken.|6 weeks|Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs taken at this time point.||percentage of resorption||Full Range|Mean
709324|NCT00147823|Other Pre-specified|Bone Trabeculation Through the Defect (BT) Compared at 3 Months|Bone trabeculation through the bone lesion compared at 3 months were reviewed with radiographs. There were several participants with incomplete follow up or incomplete radiographs.|3 months|Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs taken at this time point.||percentage of trabeculation||Full Range|Mean
709325|NCT00147823|Other Pre-specified|Resorption of Graft Material (GR) Compared at 3 Months|Percentage of graft material that is resorbed (disappears) from area of incorporation at 3 months. Participants were seen 3 month follow with radiographs to review resorption of graft material. There a several that had incomplete follow up or radiographs not taken.|3 months|Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs taken at this time point.||percentage of resorption||Full Range|Mean
709326|NCT00147823|Other Pre-specified|Bone Trabeculation Through the Defect (BT) Compared at 6 Months|Bone trabeculation through the bone lesion at 6 months was reviewed with radiographs. There were several participants with incomplete follow up or incomplete radiographs.|6 months|Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs taken at this time point.||percentage of trabeculation||Full Range|Mean
711115|NCT00167245|Secondary|Days Abstinent From Drinking, Frequency of Heavy Drinking Days, and Cocaine Use (Confirmed by Urine Drug Screen) as Measured by the Time Line Follow-Back During the Treatment Phase, Compared to Less Topiramate-adherent (<80% Pills Taken).||13 weeks||||||
709327|NCT00147823|Other Pre-specified|Resorption of Graft Material (GR) Compared at 6 Months|Percentage of graft material that is resorbed (disappears) from area of incorporation at 6 months. Participants were seen 6 month follow with radiographs to review resorption of graft material. There a several that had incomplete follow up or radiographs not taken.|6 months|Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs taken at this time point.||percentage of resorption||Full Range|Mean
709328|NCT00147823|Other Pre-specified|Bone Trabeculation Through the Defect (BT) Compared at 12 Months|Bone trabeculation through the bone lesion at 12 months was reviewed with radiographs. There were several participants with incomplete follow up or incomplete radiographs.|12 months|Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs taken at this time point.||percentage of trabeculation||Full Range|Mean
709329|NCT00147823|Other Pre-specified|Resorption of Graft Material (GR) Compared at 12 Months|Percentage of graft material that is resorbed (disappears) from area of incorporation at 12months. Participants were seen 12 month follow with radiographs to review resorption of graft material. There a several that had incomplete follow up or radiographs not taken.|12 months|Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs taken at this time point.||percentage of resorption||Full Range|Mean
709330|NCT00147823|Other Pre-specified|Bone Trabeculation Through the Defect (BT) Compared at 18 Months|Bone trabeculation through the bone lesion at 18 months with reviewed with radiographs. There were several participants with incomplete follow up or incomplete radiographs.|18 months|Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs taken at this time point.||percentage of trabeculation||Full Range|Mean
709331|NCT00147823|Other Pre-specified|Resorption of Graft Material (GR) Compared at 18 Months|Percentage of graft material that is resorbed (disappears) from area of incorporation at 18 months. Participants were seen 18 month follow with radiographs to review resorption of graft material. There a several that had incomplete follow up or radiographs not taken.|18 months|Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs taken at this time point.||percentage of resorption||Full Range|Mean
709332|NCT00147823|Other Pre-specified|Bone Trabeculation Through the Defect (BT) Compared at 24 Months|Bone trabeculation through the bone lesion at 24 months as determined with radiographs. There were several participants with incomplete follow up or incomplete radiographs. .|24 months|Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs at this time point.||percentage of trabeculation||Full Range|Mean
709333|NCT00147823|Primary|Resorption of Graft Material (GR) Compared at 24 Months|Percentage of graft material that is resorbed (disappears) from area of incorporation, at 24 months .Participants were seen 24 month follow with radiographs to review resorption of graft material. There a several that had incomplete follow up or radiographs not taken.|24 months|Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs taken at this timepoint.||percentage of resorption||Full Range|Mean
709334|NCT00147966|Primary|American College of Rheumatology (ACR) 20 at Week 12|ACR 20, the American College of Rheumatology (ACR) definition of 20% improvement is based on a 20% improvement (compared to baseline values) in tender and swollen joint counts and 20% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function) and one acute phase reactant value (CRP).|0 and 12 weeks|||participants|||Number
709335|NCT00148109|Secondary|Overall Survival|Time of cetuximab administration to clinically documented death assessed for four months|months|||months||95% Confidence Interval|Median
709336|NCT00148109|Secondary|Progression Free Survival.|Time of cetuximab administration to clinically documented progression of disease or death assessed for four months|survival|||months||95% Confidence Interval|Median
709337|NCT00148109|Primary|Number of Patients With Sarcoma Who Are Tumor Progression Free and Alive at Four Months From Start of Treatment With Single-agent Cetuximab.|Time of cetuximab administration to clinically documented progression of disease or death assessed for four months after starting cetuximab therapy|4 months|per protocol all patients that received drug were evaluated for the primary endpoint||participants|||Number
709338|NCT00148122|Secondary|Probability of Progression Free Survival|The estimated 1 year progression free survival. Progression was defined, using RECIST (Response Evaluation Criteria In Solid Tumors Criteria), as a 20% increase in the sum of the longest diameter of target lesions, the development of any new lesion, or the significant clinical deterioration related to the progression of patient's disease. The probability of progression-free survival was presented in a Kaplan-Meier curve to illustrate the distribution of progression time. The median time to progression was determined with a 95% CI (Confidence Interval).|1 year post treatment|40 patients were enrolled. 2 patients withdrew consent and 2 patients were not evaluable per protocol criteria: A patient will be considered evaluable for response if they received at least 2 cycles of chemotherapy, OR if they have obvious clinical signs of disease progression on physical examination after one cycle of chemotherapy.||percentage of patients||95% Confidence Interval|Number
709339|NCT00148122|Secondary|Frequency of Grade III/IV Toxicities Experienced by Participants|The frequency of grade 3 and grade 4 adverse events experienced by all treated participants.|30 days post treatment|40 patients were enrolled. 2 patients withdrew consent, therefore only 38 were included in the toxicity analysis.||participants|||Number
709340|NCT00148122|Primary|Overall Response Rate at 4 Months|Disease was assessed by radiologic imaging and RECIST (Response Evaluation Criteria in Solid Tumors) was used to determine response: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|4 months|40 patients were enrolled. 2 patients withdrew consent and 2 patients were not evaluable per protocol criteria: A patient will be considered evaluable for response if they received at least 2 cycles of chemotherapy, OR if they have obvious clinical signs of disease progression on physical examination after one cycle of chemotherapy.||percentage of participants|||Number
709427|NCT00141102|Secondary|Number of Subjects Withdrawn Due to GI Adverse Events (AEs)|GI AEs were defined using MedDRA SOC “Gastrointestinal Disorders” but excluding the following HLGTs: Benign Neoplasms Gastrointestinal; Dental and Gingival Conditions; Oral Soft Tissue Conditions; Salivary Gland Conditions; and Tongue Conditions.|6 month treatment duration|ITT||participants|||Number
709341|NCT00148317|Secondary|Progression Free Survival|"Response was assessed using IMWG guidelines, which for progressive disease are as follows:
Increase of > 25% from lowest response value in any one or more of the following:
Serum M-component and/or (the absolute increase must be > 0.5 g/dL)*
Urine M-component and/or (the absolute increase must be > 200 mg/24 h)
Only in patients without measurable serum and urine M-protein levels; the difference between involved and uninvolved FLC levels. The absolute increase must be > 10 mg/dL
Bone marrow plasma cell percentage; the absolute percentage must be > 10%
Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas
Development of hypercalcaemia (corrected serum calcium > 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder IF starting M protein component is > 5g/dL, then absolute increase of 1g is sufficient for progression."|Date of progression, assessed from start of trial to Final data cut off date (15 April 2011)|||months||Full Range|Median
709342|NCT00148317|Secondary|Yield of CD34+ Stem Cells|This is the yield of CD34+ stem cells collection after high dose cyclophosphamide.|Occurred after mobilization, and prior to Stem cell transplant; a 7 day limit was imposed on stem cell collection|||10^6 cells/kg||Full Range|Median
709343|NCT00148317|Primary|Efficacy of Drug Combination as Therapy for Myeloma (Overall Response Rate)|Myeloma response criteria developed by Bladé et al. was used to categorize response.|Best response at any point during each respective study phase was collected - once after consolidation/prior to mobilization (approximately 6 cycles after start of treatment), and once after mobilization|All 38 patients were treated with DoVeD consolidation therapy (Vel + DEX with or without DOXIL). Of the 38 patients enrolled, 27 proceeded to mobilization (11 did not undergo mobilization). Responses were assessed prior to mobilization (post DoVED), and again after mobilization, to see if mobilization improved patient response.||participants|||Number
709344|NCT00148668|Primary|Pathological Complete Response After Preoperative Therapy With Herceptin/Navelbine Versus Taxotere/Carboplatin/Herceptin in Patients With HER-2 Positive Early Breast Cancer|Pathological Complete Response is defined as the complete disappearance of invasive tumor in the breast at the time of surgery|12 weeks|Please Note that in Arm 2, the number of participants analyzed is equal to 39, which differs from the Number of Participants reported in the baseline measure (N= 40) because one participant withdrew her consent, so was not evaluable.||percentage of participants|||Number
709345|NCT00148733|Secondary|Folate, Cobalamin and Vitamin D Status of the Enrolled Children|And whether or not these vitamins predict treatment failure and duration of illness.|14 days||10/2017||||
709346|NCT00148733|Secondary|Will Presence of a RNA Virus Modify the Effect of Zinc|We will compare the efficacy of zinc according to virus detected in nasopharyngeal secretions|14 days||10/2017||||
709347|NCT00148733|Secondary|The Efficacy of Zinc in Malnourished and Non-malnourished Children|We will compare the efficacy of zinc in those that are stunted, wasted or underweight with those who are not.|Within 2 weeks after enrollment||10/2017||||
709348|NCT00148733|Secondary|The Efficacy of Zinc According to Breast Feeding Status and in Different Age Categories|We will measure to what extent breastfeeding status modifies the effect of zinc on pneumonia|Within 2 weeks after enrollment||10/2017||||
709349|NCT00148733|Secondary|Effect Modifiers for the Effect of Zinc Given During Pneumonia|We will also measure of there are factors at baseline that modifies the effect of zinc. Whether the following are modifiers for the above-mentioned effect of zinc given during pneumonia: i.severe inflammation, reflected in: high fever and/or elevated plasma C-reactive protein (CRP) concentration|Within 2 weeks after enrollment||10/2017||||
709350|NCT00148733|Primary|Adverse Effects|Vomiting, regurgitation, pain in abdomen for 15 minutes after zinc or placebo administration.|14 days||10/2017||||
709351|NCT00148733|Primary|Difference in Growth and Thymic Size Between the Treatment Groups Measured at Three and Six Months After the Zinc Supplementation|Thymus size will be measured using ultrasonography and compared between the two groups. at two occasions 2.5 and 6 months after end of supplementation|six months||10/2017||||
709352|NCT00148733|Primary|Active and Passive Morbidity Surveillance for Six Months After the 14-day Supplementation Period is Completed|We will measure to what extent short term zinc administration has an impact on growth and morbidity for up to 6 months after end of supplementation|six months||10/2017||||
709353|NCT00148733|Primary|Non-injury Clinic Visits and Hospital Admissions After Treatment Has Been Initiated|We will measure to what extent the intervention can reduce the number of severe events.|Within 2 weeks after enrollment||10/2017||||
709354|NCT00148733|Primary|Risk of Treatment Failure.|Enrolled children will be followed and given zinc or placebo for 14 days. We will compare the proportion with treatment failure (i.e. lack of improvement within 3 days) between the two groups|Within 2 weeks after enrollment|||participants|||Number
709355|NCT00148759|Primary|24-hr LPV AUC|Steady state(2 weeks after therapy change)|24 hours|||ng*hr/mL||Inter-Quartile Range|Geometric Mean
709356|NCT00148759|Secondary|24-hr LPV Cmax|LPV Cmax at Steady State|24 hours|||ng/mL||Inter-Quartile Range|Geometric Mean
709357|NCT00148798|Secondary|Safety - Number of Patients Experiencing Any Adverse Event|Please refer to Adverse Events section for further details|time from first dose up to 30 after last dose of study treatment, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007|Safety Population||participants|||Number
709358|NCT00148798|Secondary|A Population Pharmacokinetic (PK) Analysis for Cetuximab in Non-Small Cell Lung Cancer (NSCLC) - Serum Cetuximab Concentrations|Population PK analysis was conducted using non-linear mixed effects modeling (NONMEM) software, integrating the PK data from this study and the Phase II study EMR 62 202-011.|Week 1, Day 1: baseline and end of infusion; Week 7, Day 43: within 12 h after cetuximab administration.|||ug/mL||Standard Deviation|Mean
709359|NCT00148798|Secondary|Quality of Life Assessment (EORTC QLQ-C30) Social Functioning|Mean social functioning scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a higher level of functioning.|at baseline, at cycle 3, at month 6, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007|670 subjects completed (348 in the cetuximab + chemotherapy arm and 322 in the chemotherapy alone arm) at least 1 evaluable QLQ-C30 questionnaire and were included in the Evaluable population. Numbers at each timepoint were (Cetuximab + chemotherapy/Chemotherapy alone, respectively): baseline 280/275; cycle 3 185/153; 6 month 101/97||scores on a scale||Standard Error|Least Squares Mean
709360|NCT00148798|Secondary|Quality of Life (QOL) Assessment European Organisation for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status|Mean global health status scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a better QoL.|at baseline, at cycle 3, at month 6, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007|670 subjects completed (348 in the cetuximab + chemotherapy arm and 322 in the chemotherapy alone arm) at least 1 evaluable QLQ-C30 questionnaire and were included in the Evaluable population. Numbers at each timepoint were (Cetuximab + chemotherapy/Chemotherapy alone, respectively): baseline 278/274; cycle 3 184/153; 6 month 102/96||scores on a scale||Standard Error|Least Squares Mean
709361|NCT00148798|Secondary|Disease Control Rate|The disease control rate is defined as the proportion of subjects having achieved confirmed Complete Response + Partial Response + Stable Disease as best overall response according to radiological assessments (based on modified WHO criteria).|Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007|ITT||percentage of participants||95% Confidence Interval|Number
709362|NCT00148798|Secondary|Best Overall Response Rate|The best overall response rate is defined as the proportion of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified WHO criteria).|Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007|||percentage of participants||95% Confidence Interval|Number
709363|NCT00148798|Secondary|Progression-free Survival Time|"Duration from randomization until radiological progression (based on modified World Health Organisation (WHO) criteria) or death due to any cause.
Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment."|Time from randomization to disease progression, death or last tumor assessment, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007|ITT||months||95% Confidence Interval|Median
709364|NCT00148798|Primary|Overall Survival Time (OS)|Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.|Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007|ITT||months||95% Confidence Interval|Median
709365|NCT00148954|Secondary|Time to First Inappropriate Therapy for Which the Discrimination Algorithm Found in VITALITY 2 and Medtronic Implantable Cardioverter Defibrillator (ICDs) Inappropriately Classified the Episode||Time of event||||||
709366|NCT00148954|Secondary|Positive Predictive Value (PPV) of Ventricular Tachycardia/Fibrillation (VT/VF) Discrimination Algorithms Found in VITALITY 2 and Medtronic Implantable Cardioverter Defibrillators (ICDs)||Time of event||||||
709367|NCT00148954|Secondary|Time to First Inappropriate Shock Using VITALITY and Selected Medtronic Implantable Cardioverter Defibrillator (ICDs)||Time of event||||||
709368|NCT00148954|Primary|Number of Patients With Inappropriate Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) Therapy (Shock or Antitachycardia Pacing [ATP]) After the Pre-Discharge Visit|An inappropriate therapy is defined as a VT/VF therapy, either shock or antitachycardia pacing (ATP), delivered for a supraventricular tachycardia (SVT). All events for which a VT/VF therapy was delivered and a stored electrogram exists were reviewed by an independent adjudication committee to determine the appropriateness of device rhythm classification and subsequent therapy delivery.|From date of pre-discharge until a minimum of 12 months follow-up until study closure|||Participants|||Number
709369|NCT00149214|Secondary|Disease-free Survival|Disease-free survival is defined as the time from date of study enrollment (randomization) to first date of progressive disease (PD) or death from any cause. PD per Response Evaluation Criteria In Solid Tumors (RECIST) criteria is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. For patients not known to have died as of the data cut-off date and who do not have progressive disease, disease-free survival was censored at the last contact date.|baseline through post surgery, follow-up for 3 years post-surgery (up to 5.2 years after randomization)|All randomized participants. In the Pemetrexed plus Doxorubicin, Followed by Docetaxel arm, 99 participants were censored. In the Cyclophosphamide plus Doxorubicin, Followed by Docetaxel arm, 94 participants were censored.||months||95% Confidence Interval|Median
709370|NCT00149214|Secondary|Number of Patients With Histologically Negative Axillary Lymph Node Status at Surgery|Histologically negative is defined as no malignant cells present in the axillary lymph nodes during surgery.|surgery after eight 21-day cycles of chemotherapy|"Participants meeting the following criteria qualify for pathological tumor response:
Histologic diagnosis of primary operable breast cancer
No concurrent antitumor therapy
Specimen for evaluation of pathological response obtained upon surgery
Treatment with at least one dose of study drug of the assigned study regimen."||participants|||Number
709371|NCT00149214|Secondary|Number of Participants With a Clinical Tumor Response After the Second Sequence of Chemotherapy|The number of participants with a clinical tumor response based on measurement of tumor size after the second sequence of chemotherapy, without a second confirmatory tumor measurement required, per protocol.|Cycles 5-8 (21-day cycles)|"Participants meeting following criteria qualify for clinical tumor response:
Histologic diagnosis of primary operable breast cancer
No concurrent antitumor therapy up to surgery
Presence of measurable disease as defined by RECIST.
Treatment with at least one dose of study drug of assigned study regimen."||participants|||Number
709372|NCT00149214|Secondary|Number of Participants With a Clinical Tumor Response After the First Sequence of Chemotherapy|The number of participants with a clinical tumor response based on measurement of tumor size after the first sequence of chemotherapy, without a second confirmatory tumor measurement, per protocol.|Cycles 1-4 (21-day cycles)|"Participants meeting following criteria qualify for clinical tumor response:
Histologic diagnosis of primary operable breast cancer
No concurrent antitumor therapy up to surgery
Presence of measurable disease as defined by RECIST.
Treatment with at least one dose of study drug of assigned study regimen."||participants|||Number
709428|NCT00141102|Secondary|Number of Subjects With Moderate to Severe Abdominal Symptoms|"Abdominal symptoms were defined by the Medical Dictionary for Regulatory Activities MedDRA System Organ Class (SOC) 'Gastrointestinal Disorders' and keeping high level group term (HLGT) equal to “Gastrointestinal Signs and Symptoms."|6 month treatment duration|ITT||participants|||Number
709373|NCT00149214|Primary|Number of Participants With a Pathological Complete Response|pathological assessment of tissue removed during surgery to determine if tumor tissue is still present after chemotherapy|surgery after eight 21-day cycles of chemotherapy|"Participants meeting the following criteria qualify for pathological tumor response:
Histologic diagnosis of primary operable breast cancer
No concurrent antitumor therapy
Specimen for evaluation of pathological response obtained upon surgery
Treatment with at least one dose of study drug of the assigned study regimen."||participants|||Number
709374|NCT00149227|Secondary|Uncontrolled Blood Pressure, Etc.||five years||||||
709375|NCT00149227|Secondary|New Onset or Worsening of Diabetes Mellitus or IGT|"Diabetes mellitus was defined as fasting plasma glucose >=126 mg/dl, causal blood glucose >= 200 mg /dl, HbA1C >= 6.5%, and/or plasma glucose 2hr after 75g glucose load >= 200 mg/dl. The first of these events, new onset diabetes or worsening diabetes following IGT, occurring in a specific patient was classified as an event to be counted in the secondary endpoint by the Endpoint Committee. We estimated the number of enrolled patients to validate the hypothesis under the assumption that the valsartan add-on group achieves a 20% risk reduction compared with the conventional treatment group and gives 80% statistical power for detecting a clinical signiﬁcance with a two-tailed 5% statistical signiﬁcant level."|five years|||event number|||Number
709376|NCT00149227|Secondary|New Onset or Worsening of Arrhythmias||five years||||||
709377|NCT00149227|Secondary|Worsening of Cardiac Function||five years||||||
709378|NCT00149227|Secondary|All Cause Mortality||five years|||patients|||Number
709379|NCT00149227|Primary|Transition to Dialysis, Doubling of Plasma Cr Levels|"The first of any events, transition to dialysis or doubling of plasma Cr levels compared to the entry, occurring in a specific patient was classified as an event to be counted in the primary endpoint by the Endpoint Committee. We estimated the number of enrolled patients to validate the hypothesis under the assumption that the valsartan add-on group achieves a 20% risk reduction compared with the conventional treatment group and gives 80% statistical power for detecting a clinical signiﬁcance with a two-tailed 5% statistical signiﬁcant level."|five years|||event number|||Number
709380|NCT00149227|Primary|New Onset, Recurrence or Worsening of Arteriosclerosis Obliterans|Arteriosclerosis obliterans (ASO) event was diagnosed with symptoms and CT / MRI imaging. The first of any of these events to occur in a specific patient was classified as an event to be counted in the primary endpoint by the Endpoint Committee. We estimated the number of enrolled patients to validate the hypothesis under the assumption that the valsartan add-on group achieves a 20% risk reduction compared with the conventional treatment group and gives 80% statistical power for detecting a clinical signiﬁcance with a two-tailed 5% statistical signiﬁcant level.|five years|||event number|||Number
709381|NCT00149227|Primary|New Onset of Acute Dissecting Aneurysm of the Aorta|Dissecting aneurysm of the aorta required hospitalization and was diagnosed by imaging technique, CT and/or MRI. The first of any of these events to occur in a specific patient was classified as an event to be counted in the primary endpoint by the Endpoint Committee. We estimated the number of enrolled patients to validate the hypothesis under the assumption that the valsartan add-on group achieves a 20% risk reduction compared with the conventional treatment group and gives 80% statistical power for detecting a clinical signiﬁcance with a two-tailed 5% statistical signiﬁcant level.|five years|||event number|||Number
709382|NCT00149227|Primary|Operation of PCI or Bypass Operation||five years||||||
709383|NCT00149227|Primary|Hospitalization Due to the New Onset, Occurrence or Worsening of Angina Pectoris and Additional Concomitant Use of Other Anti-anginal Agents or Increase of Dosage|Angina pectoris event required hospitalization and was diagnosed by both ECG changes corresponding with chest symptoms and coronary angiography showing 75% stenosis according to AHA/ACC guidelines. The first of any of these events to occur in a specific patient was classified as an event to be counted in the primary endpoint by the Endpoint Committee. We estimated the number of enrolled patients to validate the hypothesis under the assumption that the valsartan add-on group achieves a 20% risk reduction compared with the conventional treatment group and gives 80% statistical power for detecting a clinical signiﬁcance with a two-tailed 5% statistical signiﬁcant level.|five years|||event number|||Number
709384|NCT00149227|Primary|Hospitalization Due to the New Onset, Recurrence or Worsening of Heart Failure and Additional Concomitant Use of Other Anti-heart Failure Agents or Increase of Dosage|Heart failure event was defined as requiring hospitalization and clinical symptoms together with left ventricular dysfunction by echocardiography according to the guidelines of the AHA/ACC. The first of any of these events to occur in a specific patient was classified as an event to be counted in the primary endpoint by the Endpoint Committee. We estimated the number of enrolled patients to validate the hypothesis under the assumption that the valsartan add-on group achieves a 20% risk reduction compared with the conventional treatment group and gives 80% statistical power for detecting a clinical signiﬁcance with a two-tailed 5% statistical signiﬁcant level.|five years|||event number|||Number
709385|NCT00149227|Primary|New Onset or Recurrence of Acute Myocardial Infarction|Acute myocardial infarction was diagnosed with hospitalization, ECG- change, and biomarkers for myocardial infarction. The first of any of these events to occur in a specific patient was classified as an event to be counted in the primary endpoint by the Endpoint Committee. We estimated the number of enrolled patients to validate the hypothesis under the assumption that the valsartan add-on group achieves a 20% risk reduction compared with the conventional treatment group and gives 80% statistical power for detecting a clinical signiﬁcance with a two-tailed 5% statistical signiﬁcant level.|five years|||event number|||Number
709386|NCT00149227|Primary|New Onset or Recurrence of Transient Ischemic Attack|Transient ischemic attack (TIA) was defined as hospitalization with sudden onset of neurological deficit persisting for less than 24 hrs, and without abnormal findings using by CT and/or MRI. The first of any of these events to occur in a specific patient was classified as an event to be counted in the primary endpoint by the Endpoint Committee. We estimated the number of enrolled patients to validate the hypothesis under the assumption that the valsartan add-on group achieves a 20% risk reduction compared with the conventional treatment group and gives 80% statistical power for detecting a clinical signiﬁcance with a two-tailed 5% statistical signiﬁcant level.|five years|||event number|||Number
709629|NCT00141817|Primary|Plasma Concentrations After Multiple Doses||Hours 2 and 4 on Day 7|Multiple-Dose Valid-for-Evaluation Population: Randomized participants who had concentration evaluations of pantoprazole either at 2 hours or at 4 hours after single dose and after at least 5 consecutive doses. n=participants who had data available at that specific time point.||ng/mL||Standard Deviation|Mean
709387|NCT00149227|Primary|New Onset or Recurrence of Stroke|Stroke events included brain hemorrhage, infarction, and TIA. They required hospitalization with neurological symptoms and were diagnosed by CT and/or MRI. The first of any of these events to occur in a specific patient was classified as an event to be counted in the primary endpoint by the Endpoint Committee. We estimated the number of enrolled patients to validate the hypothesis under the assumption that the valsartan add-on group achieves a 20% risk reduction compared with the conventional treatment group and gives 80% statistical power for detecting a clinical signiﬁcance with a two-tailed 5% statistical signiﬁcant level.|five years|Analyses were made by the independent Statistical Analysis Organization based on the intention-to-treat principle.||event number|||Number
709388|NCT00133575|Secondary|Assessment of Dryvax Take Category|"Restricted to participants who received Dryvax 6-15 months after MVA. A take is a vesicle surrounded by a red areola which becomes umbilicated and then pustular before scabbing. Category 0=No take; Category 1=Significant modified take skin reaction; Category 2=Modified take skin reaction; Category 3=Primary take skin reaction"|3 weeks after Dryvax challenge|||Participants|||Number
709389|NCT00133575|Secondary|Peak Titer of Viral Shedding Post Dryvax Challenge|Median Dryvax virus titers as assessed from swabs of the vaccination site lesion taken at intervals until the vaccination site is scabbed. The maximum titer recovered during the sampling period for each participant is utilized in determining the median for the group.|Until vaccination site lesion has scabbed|||Titers||Full Range|Median
709390|NCT00133575|Secondary|Peak T-cell Gamma Interferon Responses (ELISPOT)|Median T-cell gamma interferon responses against the vaccinia virus as the assay antigen, as assessed by ELISPOT from sera collected 2 weeks after receipt of 2 doses. Responses are expressed as the number of spot forming units per 10^6 peripheral blood mononuclear cells (SFU/10^6 PBMC).|Approximately Day 42 after first vaccination|||SFU/10^6 PBMC||Inter-Quartile Range|Median
709391|NCT00133575|Secondary|Peak Binding Antibodies (ELISA) to Vaccinia|Median binding antibody titers against vaccinia virus as the ELISA assay antigen, as assessed from sera collected 2 weeks after receipt of 2 doses.|Approximately Day 42 after first vaccination|||Titers||Inter-Quartile Range|Median
709392|NCT00133575|Secondary|Peak Binding Antibodies (ELISA) to ACAM3000 MVA|Median binding antibody titers against ACAM3000 MVA as the ELISA assay antigen, as assessed from sera collected 2 weeks after receipt of 2 doses.|Approximately Day 42 after first vaccination|||Titers||Inter-Quartile Range|Median
709393|NCT00133575|Secondary|Peak Neutralizing Antibodies to Vaccinia|Median neutralizing antibody titers against vaccinia virus as the assay antigen, as assessed from sera collected 2 weeks after receipt of 2 doses.|Approximately Day 42 after first vaccination|||Titers||Inter-Quartile Range|Median
709394|NCT00133575|Secondary|Peak Neutralizing Antibodies to ACAM3000 MVA|Median neutralizing antibody titers against ACAM3000 MVA as the assay antigen, as assessed from sera collected 2 weeks after receipt of 2 doses.|Approximately Day 42 after first vaccination|||Titers||Inter-Quartile Range|Median
709395|NCT00133575|Primary|Number of Participants With Signs of Possible Myopericarditis|Number of participants with signs of possible myopericarditis, either by clinical or laboratory (EKG, troponin) evaluation, at any time after vaccination for the during of the study|Within 360 days after vaccination|||Participants|||Number
709396|NCT00133575|Primary|Number of Participants With Urinalysis Laboratory Abnormalies After Vaccination|Number of participants with urinalysis laboratory abnormalies after vaccination, including proteinuria and hematuria by dipstick. Participants are counted only once for each parameter but may have experienced an abnormality of that parameter on multiple occasions.|28 days after vaccination|||Participants|||Number
709397|NCT00133575|Primary|Number of Participants With Enzymatic Clinical Laboratory Abnormalities After Vaccination|Number of participants with enzymatic clinical laboratory abnormalities after vaccination, including AST, ALT and alkaline phosphatase. Participants are counted only once for each parameter but may have experienced an abnormality of that parameter on multiple occasions|28 days after vaccination|||Participants|||Number
709398|NCT00133575|Primary|Number of Participants With Clinical Chemistry Laboratory Abnormalities After Vaccination|Number of participants with clinical chemistry laboratory abnormalities after vaccination, including total bilirubin and serum creatinine. Participants are counted only once for each parameter but may have experienced an abnormality of that parameter on multiple occasions.|28 days after vaccination|||Participants|||Number
709399|NCT00133575|Primary|Number of Participants With Hematologic Laboratory Abnormalities After Vaccination|Number of participants with hematologic laboratory abnormalities after vaccination, including hemoglobin, white blood cell count, neutrophil count and platelet count. Participants are counted only once for each parameter but may have experienced an abnormality of that parameter on multiple occasions.|28 days after vaccination|||Participants|||Number
709400|NCT00133575|Primary|Number of Participants Reporting Moderate or Greater Solicited Systemic Reactions|Number of participants reporting moderate or greater systemic reactions solicited on the memory aid as well as by study personnel at follow up visits after either vaccination. Participants are counted only once but may have experienced symptoms on multiple occasions.|15 days after vaccination|||Participants|||Number
709401|NCT00133575|Primary|Number of Participants Reporting Moderate or Greater Solicited Local Reactions|Number of participants reporting moderate or greater local reactions solicited on the memory aid as well as by study personnel at follow up visits after either vaccination. Participants are counted only once but may have experienced symptoms on multiple occasions.|15 days after vaccination|||Participants|||Number
709402|NCT00133705|Primary|Uterine Volume|Uterine volume is measured in mLs|6 months|||mL||Standard Deviation|Mean
709403|NCT00140556|Secondary|Failure Free Survival||3 yrs||||||
709404|NCT00140556|Secondary|Local Regional Control||1 yr following chemoradiation||||||
709405|NCT00140556|Primary|Tumor Resolution|Complete response (resolution) of tumor on clinical exam.|Within 30 days of completing RT|2 participants had occult primaries, thus were not included in clinical complete response||Participants|||Number
709406|NCT00140621|Primary|Change From Baseline in LVM at Week 156|Left ventricular mass was assessed by echocardiogram.|Baseline to Week 156|EEP.||gm||95% Confidence Interval|Least Squares Mean
709407|NCT00140621|Primary|Percent Change From Baseline in Left Ventricular Mass (LVM) at Week 156|Left ventricular mass was assessed by echocardiogram.|Baseline to Week 156|EEP.||percent change||95% Confidence Interval|Least Squares Mean
709408|NCT00140621|Secondary|Change From Baseline in Short Form (36) Health Survey (SF-36) Scores at Week 156|The 36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical component score (PCS) and mental component score (MCS). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline to Week 156|EEP.||units on a scale||Standard Deviation|Mean
709409|NCT00140621|Secondary|Percent Change From Baseline in GL-3 Plasma Levels at Week 156||Baseline to Week 156|EEP.||percent change||95% Confidence Interval|Least Squares Mean
709410|NCT00140621|Secondary|Number of Participants in Overall Cardiac Function Assessment and Clinical Symptoms at Week 156: Change From Baseline in Cardiac Function Test|Overall cardiac function assessment was assessed by tests (echocardiogram,cardiac catheterization (optional),electrocardiogram,B-type natriuretic peptide [BNP]), clinical symptoms (subjective symptoms) and the New York Heart Association (NYHA) cardiac functional classification.Overall assessment of cardiac function was assessed based on the evaluation items including interventricular septum thickness, left ventricular posterior wall thickness, left ventricular mass, clinical function tests and clinical symptoms. A subject was considered to be Improved: if Improved in 2 items or more, Unchanged: Improved in one item and unchanged in 2 items or unchanged in all 3 items, Aggravated: Aggravated in one item or more.|Baseline to Week 156|EEP.||participants|||Number
709411|NCT00140621|Primary|Change From Baseline in Interventricular Septum and Left Ventricular Posterior Wall Thickness at Week 156|Interventricular septum and left ventricular posterior wall thickness was assessed by echocardiogram.|Baseline to Week 156|EEP.||mm||95% Confidence Interval|Least Squares Mean
709412|NCT00140621|Primary|Percent Change From Baseline in Interventricular Septum and Left Ventricular Posterior Wall Thickness at Week 156|Interventricular septum and left ventricular posterior wall thickness was assessed by echocardiogram.|Baseline to Week 156|EEP.||percent change||95% Confidence Interval|Least Squares Mean
709413|NCT00140842|Secondary|Visceral Adipose Tissue|Visceral adipose tissue was measured using magnetic resonance imaging at the level of the fourth lumbar vertebra (L4)|Baseline|The analysis was completed on the 30 participants as per protocol||grams||Standard Deviation|Mean
709414|NCT00140842|Primary|Peak Growth Hormone (GH) on the GH Stimulation Test|Peak growth hormone (GH) on the GH stimulation test is a measure of the adequacy of GH secretion.|Baseline|This was a cross-sectional study to compare differences in growth hormone (GH) secretory status in relation to body composition in obese versus normal-weight girls. This was a pilot study and the analysis was performed using a Student t-test to compare means across groups||ng/ml||Standard Deviation|Mean
709415|NCT00141037|Primary|Comparison by Treatment Assignment in the Number of Biopsy-Proven Acute Rejections Within 12 Months Post Kidney Transplantation|"Biopsy-proven acute renal (kidney) rejection [1, 2].
Diagnosis of acute rejection was made by renal biopsy using the Banff 97 criteria. The Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Acute rejection is defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection[2]
Ref: Racusen LC et al. The Banff 97 working classification of renal allograft pathology. Kidney Int, 55: 713-723, 1999"|Up to one year post kidney transplantation procedure|All Enrolled Subjects||Rejection Events||95% Confidence Interval|Number
709416|NCT00141037|Primary|The Difference in Linear Growth by Treatment Assignment at 1 Year Post Kidney Transplantation|Standardized Z-scores were computed following a formula using an age- and gender-specific calculation provided by the NHANES III 2000 Growth Data set. The Z-score system expresses anthropometric values of height as several standard deviations (SDs) below (e.g., a negative value) or above (a positive value) the reference mean or median value. In this study the measure was used to test whether there is a difference in the change in height between the treatment groups: Steroid-Based versus Steroid-Free|One year post kidney transplantation procedure|All Enrolled Subjects||Standard Deviation Score (SDS)||Standard Deviation|Mean
709417|NCT00141102|Other Pre-specified|Number of Subjects Hospitalized in Last 6 Months at the Post Trial Interview|Interview occurred via telephone to obtain follow-up mortality and hospitalization information.|6 months following last dose|Safety population. Number of participants analyzed = number of subjects with follow-up information available.||participants|||Number
709418|NCT00141102|Other Pre-specified|Number of Subjects Alive at the Post Trial Interview|Interview occurred via telephone to obtain follow-up mortality and hospitalization information.|6 months following last dose|Safety population. Number of participants analyzed = number of subjects with follow-up information available.||participants|||Number
709419|NCT00141102|Secondary|Change From Baseline in C-Reactive Protein to Month 6/ET||Month 6/ET|Safety population. Number of participants analyzed = number of subjects with analyzable data.||mg/dL||Standard Error|Least Squares Mean
709420|NCT00141102|Secondary|Change From Baseline in Ferretin to Month 6/ET||Month 6/ET|Safety population. Number of participants analyzed = number of subjects with analyzable data.||ug/dL||Standard Error|Least Squares Mean
709421|NCT00141102|Secondary|Change From Baseline in Iron Binding Capacity to Month 6/ET||Month 6/ET|Safety population. Number of participants analyzed = number of subjects with analyzable data.||microgram (ug)/dL||Standard Error|Least Squares Mean
709422|NCT00141102|Secondary|Change From Baseline in Hepatic Measures of GGT, AST or ALT to Month 6/ET||Month 6/ET|Safety population. Number of participants analyzed = number of subjects with analyzable data.||IU/L||Standard Error|Least Squares Mean
709423|NCT00141102|Secondary|Number of Subjects With Hepatic AEs in Gamma Glutamyl-Transferase (GGT), Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) of 3 Times the Upper Limit of Normal (ULN)|GGT ULN was 49 international units (IU)/liter (L) for females and 61 IU/L for males, AST ULN was 37 IU/L for females and 39 IU/L for males, and ALT ULN was 43 IU/L for females and 45 IU/L for males.|6 month treatment duration|Safety population. Number of participants analyzed = number of subjects with analyzable data.||participants|||Number
709424|NCT00141102|Secondary|Number of Subjects With a Clinically Significant Decrease From Baseline in Hematocrit and/or Hemoglobin|A clinically significant decrease from baseline was defined as a fall in hematocrit > = 10 percentage points and/or hemoglobin > = 2 g/dL.|6 month treatment duration|Safety population. Number of Participants Analyzed = number of subjects with analyzable data.||participants|||Number
709429|NCT00141102|Secondary|Number of Subjects With CSULGIEs by History of GD Ulceration|CSULGIE=any of the following: gastroduodenal (GD) hemorrhage; gastric outlet obstruction; GD, small or large bowel perforation; small or large bowel hemorrhage; clinically significant anemia of defined GI origin; acute GI hemorrhage of unknown origin, including presumed small bowel hemorrhage; clinically significant anemia of presumed occult GI origin including possible small bowel blood loss. Subjects were assessed by an independent GI Events Adjudication Committee, who were blinded to study treatment assignments.|6 month treatment duration|ITT. n = number of subjects who had history or no history of GD ulceration.||participants|||Number
709430|NCT00141102|Secondary|Number of Subjects With SUs|Subjects with evaluation at an event visit and found to have an ulcer on endoscopy, but did not meet any criteria considered for the primary endpoint by the GI committee were designated as having an SU.|6 month treatment duration|ITT.||participants|||Number
709431|NCT00141102|Secondary|Change From Baseline in Patient’s Global Arthritis Assessment at Month 6/Early Termination (ET)|Subjects rated response to question: “Considering all the ways the osteoarthritis or rheumatoid arthritis affects you, how are you doing today?” using a 1 to 5 grading scale where 1=very good and 5=very poor.|Month 6/Early Termination (ET)|ITT. Number of Participants Analyzed = number of subjects with data available for the analysis. Last Observation Carried Forward (LOCF) method was used.||scores on a scale||Standard Error|Least Squares Mean
709432|NCT00141102|Secondary|Number of Subjects With CSULGIES or Symptomatic Ulcers (SUs)|CSULGIE=any of the following: GD hemorrhage; gastric outlet obstruction; GD, small or large bowel perforation; small or large bowel hemorrhage; clinically significant anemia of defined GI origin; acute GI hemorrhage of unknown origin, including presumed small bowel hemorrhage; clinically significant anemia of presumed occult GI origin including possible small bowel blood loss. Subjects with evaluation at an event visit and found to have an ulcer on endoscopy, but did not meet any criteria considered for the primary endpoint by the GI committee were designated as having an SU.|6 month treatment duration|ITT. n = number of subjects with CSULGIEs or SUs as confirmed by the committee.||participants|||Number
709433|NCT00141102|Primary|Number of Subjects With Clinically Significant Upper and/or Lower Gastrointestinal Events (CSULGIEs)|CSULGIE=any of the following: gastroduodenal (GD) hemorrhage; gastric outlet obstruction; GD, small or large bowel perforation; small or large bowel hemorrhage; clinically significant anemia of defined GI origin; acute GI hemorrhage of unknown origin, including presumed small bowel hemorrhage; clinically significant anemia of presumed occult GI origin including possible small bowel blood loss. Subjects were assessed by an independent GI Events Adjudication Committee, who were blinded to study treatment assignments.|6 month treatment duration|Intent-to-Treat (ITT) = included all randomized subjects. n = number of subjects with events confirmed by the committee.||participants|||Number
709434|NCT00141115|Primary|Participants Who Reported Reductions in Alcohol Consumption|Number of participants who reduced drinking during the trial|over 9 weeks of study or length of participation|Number of participants who were drinking less at the end of the study compared to the beginning.||Participants|||Count of Participants
709435|NCT00141219|Secondary|Duration Adjusted Average Change (DAAC) of (Unadjusted) Mean Pain Score|DAAC is a score used to assess treatment effects averaged over the entire length of the study. DAAC from baseline to weekly mean pain score was derived by calculating the mean of all post-baseline scores minus baseline mean pain score, and then weighing this according to the proportion of the planned study duration the subject actually completed.|Weeks 1 to 8|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. For subjects who did not complete the study, the last 7 observations while on study medication were carried forward (LOCF).||score on scale||Standard Deviation|Mean
709436|NCT00141219|Secondary|Clinical Global Impression of Change (CGIC)|CGIC is a clinician-rated instrument that assesses the subject’s overall global improvement on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improved = minimally improved, much improved, and very much improved; Worse = minimally worse, much worse, and very much worse.|Week 8|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. CGIC was measured at Week 8. For subjects not completing the study, their final data were considered Week 8 data; those without final data were excluded from analysis.||participants|||Number
709437|NCT00141219|Secondary|Patient Global Impression of Change (PGIC)|PGIC is a subject-rated instrument that measured change in subject’s overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improved = minimally improved, much improved, and very much improved; Worse = minimally worse, much worse, and very much worse.|Week 8|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. PGIC was measured at Week 8. For subjects not completing the study, their final data were considered Week 8 data; those without final data were excluded from analysis.||participants|||Number
709438|NCT00141219|Secondary|Hospital Anxiety and Depression Scale- Depression (HADS-D) Score|HADS-D consists of 7 items that are assessed by a score of 0 = no depression to 3 = severe feeling of depression. The depression subscale focuses on the state of lost interest and diminished pleasure response (“lowering of hedonic tone”). Score range = 0 to 21; higher scores indicate a greater intensity of depression|Week 8|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. HADS was measured at baseline and Week 8. For subjects not completing the study, their final data were considered Week 8 data; those without final data were excluded from analysis.||score on scale||95% Confidence Interval|Least Squares Mean
709439|NCT00141219|Secondary|Hospital Anxiety and Depression Scale- Anxiety (HADS-A) Score|HADS-A consists of 7 items that are assessed by a score of 0 = no anxiety to 3 = severe feeling of anxiety. The anxiety subscale determines a state of generalized anxiety (including anxious mood, restlessness, anxious thoughts, panic attacks). Score range = 0 to 21; higher scores indicate a greater intensity of anxiety|Week 8|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. HADS was measured at baseline and Week 8. For subjects not completing the study, their final data were considered Week 8 data; those without final data were excluded from analysis.||score on scale||95% Confidence Interval|Least Squares Mean
711116|NCT00167245|Secondary|Fewer Days of Cocaine Use as Measured by the Time Line Follow Back in the Follow-up Period After Discontinuing Medication, Compared to Placebo-treated Subjects.||12 weeks||||||
709440|NCT00141219|Secondary|Euro Quality of Life (EQ-5D) Visual Analog Scale (VAS)|EQ-5D is a subject-completed questionnaire to assess health-related QOL (Health State Profile (HSP) & Visual Analog Scale (VAS)). The VAS is designed to rate the subject’s current health state on a scale from 0 to 100 where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.|Week 8|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. EQ-5D was measured at baseline and Week 8. For subjects not completing the study, their final data were considered Week 8 data; those without final data were excluded from analysis.||score on scale||95% Confidence Interval|Least Squares Mean
709441|NCT00141219|Secondary|Euro Quality of Life (QOL) (EQ-5D) Utility Score|EQ-5D, a subject-completed questionnaire, assesses health-related QOL. QOL Health State Profile (HSP) is designed to record subject’s level of current health across 5 domains (mobility, self-care, usual activities, pain/discomfort & anxiety/depression); scores are used to calculate EQ-5D Utility Score; range: -0.594 to 1.000 (from worst to best).|Week 8|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. EQ-5D was measured at baseline and Week 8. For subjects not completing the study, their final data were considered Week 8 data; those without final data were excluded from analysis.||score on scale||95% Confidence Interval|Least Squares Mean
709442|NCT00141219|Secondary|Medical Outcome Study (MOS) Overall Sleep Problems Index|MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Overall Sleep Problems Index is a 9-item sub-scale; scores range from 0 to 100, lower scores indicate fewer sleep problems.|Week 8|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. MOS was measured at baseline and Week 8. For subjects not completing the study, their final data were considered Week 8 data; those without final data were excluded from the analysis.||score on scale||95% Confidence Interval|Least Squares Mean
709443|NCT00141219|Secondary|Medical Outcome Study (MOS) Somnolence|MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Somnolence sub-scale scores range from 0 to 100, lower scores indicate less somnolence.|Week 8|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. MOS was measured at baseline and Week 8. For subjects not completing the study, their final data were considered Week 8 data; those without final data were excluded from the analysis.||score on scale||95% Confidence Interval|Least Squares Mean
709444|NCT00141219|Secondary|Medical Outcome Study (MOS) Sleep Adequacy|MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Sleep Adequacy sub-scale scores range from 0 to 100, higher scores indicate greater sleep adequacy.|Week 8|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. MOS was measured at baseline and Week 8. For subjects not completing the study, their final data were considered Week 8 data; those without final data were excluded from the analysis.||score on scale||95% Confidence Interval|Least Squares Mean
709445|NCT00141219|Secondary|Medical Outcome Study (MOS) Optimal Sleep: Number of Participants With Optimal Sleep|MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Optimal Sleep sub-scale score is a binary outcome derived from Sleep Quantity (SQ): the response is YES (or 1) if SQ = 7 or 8 hours per night.|Week 8|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. MOS was measured at baseline and Week 8. For subjects not completing the study, their final data were considered Week 8 data; those without final data were excluded from the analysis.||participants|||Number
709446|NCT00141219|Secondary|Medical Outcome Study (MOS) Sleep Quantity|MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Sleep Quantity sub-scale scores range from 0 to 24 (number of hours slept).|Week 8|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. MOS was measured at baseline and Week 8. For subjects not completing the study, their final data were considered Week 8 data; those without final data were excluded from the analysis.||score on scale||95% Confidence Interval|Least Squares Mean
709447|NCT00141219|Secondary|Medical Outcome Study (MOS) Awaken Short of Breath or Headache|MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Awaken Short of Breath or with a Headache sub-scale scores range from 0 to 100, lower scores indicate less difficulty.|Week 8|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. MOS was measured at baseline and Week 8. For subjects not completing the study, their final data were considered Week 8 data; those without final data were excluded from the analysis.||score on scale||95% Confidence Interval|Least Squares Mean
709448|NCT00141219|Secondary|Medical Outcome Study (MOS) Snoring Score|MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Snoring sub-scale scores range from 0 to 100, lower scores indicate less snoring.|Week 8|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. MOS was measured at baseline and Week 8. For subjects not completing the study, their final data were considered Week 8 data; those without final data were excluded from analysis.||score on scale||95% Confidence Interval|Least Squares Mean
709449|NCT00141219|Secondary|Medical Outcome Study (MOS) Sleep Disturbance|MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Sleep Disturbance sub-scale scores range from 0 to 100, lower scores indicate less disturbance.|Week 8|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. MOS was measured at baseline and Week 8. For subjects not completing the study, their final data were considered Week 8 data; those without final data were excluded from analysis.||score on scale||95% Confidence Interval|Least Squares Mean
709450|NCT00141219|Secondary|Mean Sleep Score as Computed by DSIS.|DSIS consists of an 11-point rating scale ranging from 0 = pain did not interfere with sleep to 10 = pain completely interfered with sleep. Overall Comparison= 8-week average.|Weeks 1 to 8|ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. Missing Weekly mean scores were not imputed. Number of subjects analyzed differed by week; noted as n = (pregabalin, placebo).||score on scale||Standard Error|Least Squares Mean
709451|NCT00141219|Secondary|Mean Sleep Interference Score Based on Daily Sleep Interference Scale (DSIS).|DSIS consists of an 11-point rating scale (0 = pain did not interfere with sleep to 10 = completely interfered with sleep). Higher score indicating greater level of sleep disturbance.|Endpoint- Week 8 or Early Discontinuation|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. For subjects who did not complete the study, the last 7 available daily sleep interference scores while on study medication were carried forward (LOCF) to calculate the endpoint mean score.||score on scale||95% Confidence Interval|Least Squares Mean
709452|NCT00141219|Secondary|Duration Adjusted Average Change (DAAC) of (Adjusted) Mean Pain Score|DAAC is a score used to assess treatment effects averaged over the entire length of the study. DAAC from baseline to weekly mean pain score was derived by calculating the mean of all post-baseline scores minus baseline mean pain score, and then weighing this according to the proportion of the planned study duration the subject actually completed.|Weeks 1 to 8|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. Subjects without any post-baseline daily pain scores would have no DAAC; missing DAACs were not imputed.||score on scale||95% Confidence Interval|Least Squares Mean
709453|NCT00141219|Secondary|Daily Pain Rating Scale (DPRS)- Weekly Mean Pain Score|DPRS is 11-point rating scale (0=no pain to 10=worst possible pain). Subjects instructed to describe pain (upon awakening) during preceding 24 hrs by choosing appropriate number between 0-10. Mean endpoint pain score obtained from last 7 available DPRS scores of daily pain diary while subject on study medication. Overall Comparison=8-week average.|Weeks 1 to 8|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. Missing Weekly mean scores were not imputed. Number of subjects analyzed differed by week; noted as n= (pregabalin, placebo).||score on scale||Standard Error|Least Squares Mean
709454|NCT00141219|Other Pre-specified|Daily Pain Rating Scale (DPRS)- Mean Pain Scores (Evaluable Population)|DPRS is 11-point rating scale from 0 (no pain) to 10 (worst possible pain). Subjects instructed to describe their pain (daily upon awakening) during preceding 24 hrs by choosing the appropriate number between 0-10. Mean endpoint pain score was obtained from the last 7 available DPRS scores of the daily pain diary while subject on study medication.|Endpoint- Week 8 or Early Discontinuation|"Evaluable (EVAL) Population: Subset of ITT subjects with ≥4 daily pain diaries in the 7 days before Visit 2 (randomization) with average score ≥4; ≥14 days of treatment; ≥14 days of DB daily pain diaries; not withdrawn due to Protocol violation or Did not meet entrance criteria; not previously participated in the study."||score on scale||95% Confidence Interval|Least Squares Mean
709455|NCT00141219|Primary|Daily Pain Rating Scale (DPRS)- Mean Pain Score (ITT Population)|DPRS is 11-point rating scale from 0 (no pain) to 10 (worst possible pain). Subjects instructed to describe their pain (daily upon awakening) during preceding 24 hrs by choosing the appropriate number between 0-10. Mean endpoint pain score was obtained from the last 7 available DPRS scores of the daily pain diary while subject on study medication.|Endpoint- Week 8 or Early Discontinuation|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. For subjects who did not complete the study, the last 7 available daily pain scores while on study medication were carried forward (LOCF) to calculate the endpoint mean score.||score on scale||95% Confidence Interval|Least Squares Mean
709456|NCT00141219|Secondary|Daily Pain Rating Scale (DPRS)- Number of 50% Responders (With Respect to Pain Scores)|DPRS consists of an 11-point rating scale ranging from 0 (no pain) to 10 (worst possible pain). A 50% responder at endpoint is a subject who has a 50% or more reduction in mean pain score at endpoint compared to baseline.|Endpoint- Week 8 or Early Discontination|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. For subjects who did not complete the study, the last 7 available daily pain scores while on study medication were carried forward (LOCF) to calculate the endpoint mean score.||participants|||Number
709457|NCT00141219|Secondary|Daily Pain Rating Scale (DPRS)- Number of 30% Responders (With Respect to Pain Scores)|DPRS consists of an 11-point rating scale ranging from 0 (no pain) to 10 (worst possible pain). A 30% responder at endpoint is a subject who has a 30% or more reduction in mean pain score at endpoint compared to baseline|Endpoint- Week 8 or Early Discontinuation|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. For subjects who did not complete the study, the last 7 available daily pain scores while on study medication were carried forward (LOCF) to calculate the endpoint mean score.||participants|||Number
709458|NCT00141271|Secondary|Change in Affective Interference Test, Delayed Recognition, Non-Emotional Words False Alarms at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition which measures number of correct non-eEmotional word's false alarms(at delayed recognition). Higher number of words = greater cognition|Baseline to Week 6 LOCF|Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.||Number Correct||Standard Error|Least Squares Mean
709459|NCT00141271|Secondary|Change in Affective Interference Test, Delayed Recognition, Non-Emotional Words at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition which measures number of Non-Emotional Words (Delayed Recognition); higher number of words = better cognition|Baseline to Week 6 LOCF|Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.||Number Correct||Standard Error|Least Squares Mean
709630|NCT00141817|Primary|Terminal-Phase Volume of Distribution (Vz/F)|Vz/F was calculated as the ratio of clearance (CL) to terminal disposition rate constant (λz).|Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose|Single-Dose Valid-for-Evaluation Population. Participants analyzed=number of participants with available data.||liter per kilogram (L/kg)||Standard Deviation|Mean
709460|NCT00141271|Secondary|Change in Affective Interference Test, Delayed Recognition, Emotional Words False Alarms at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. Test in Brief Assessment of Cognition which measures number of correct emotional word's false alarms (during delayed recognition). Higher number = better cognition|Baseline to 6 Weeks LOCF|Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.||Number Correct||Standard Error|Least Squares Mean
709461|NCT00141271|Secondary|Change in Affective Interference Test, Delayed Recognition, Emotional Words at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. Test in Brief Assessment of Cognition in which the number of correct emotional words in delayed recognition is measured. Range 0-75 with higher numbers showing better cognition.|Baseline to 6 Weeks LOCF|Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6||Words||Standard Error|Least Squares Mean
709462|NCT00141271|Secondary|Change in Tower of London Test at Endpoint|Change is observed value at each visit minus baseline value. Endpoint: LOCF endpoint among Week 1 through Week 6. Brief Assessment of Cognition: subjects asked to arrange balls in 2 pictures so they are identical and give the total number of ball movements to reach this arrangment. Range: 0-22; more correct = better cognition.|Baseline to 6 Weeks LOCF|Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.||Number Correct||Standard Error|Least Squares Mean
709463|NCT00141271|Secondary|Change in Symbol Coding at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition. For 90 seconds, Patient writes numerals 1-9 as matched to symbols. Range 0 to 110 with higher totals = better cognition.|Baseline to 6 Weeks LOCF|Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.||Total Correct||Standard Error|Least Squares Mean
709464|NCT00141271|Secondary|Change in Verbal Fluency Controlled Word Association at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition. Patients given 60 seconds to generate as many words as possible that begin with a given letter; better verbal fluency = more words|Baseline to 6 Weeks LOCF|Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.||Number Correct||Standard Error|Least Squares Mean
709465|NCT00141271|Secondary|Change in Verbal Fluency in Naming Categories at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition.Patients are given 60 seconds to name as many words as possible within a given category. The more words named=better cognition.|Baseline to 6 Weeks LOCF|Intent to treat (ITT) population observed cases.Endpoint is LOCF endpoint among Week 1 through Week 6.||Number Correct||Standard Error|Least Squares Mean
709466|NCT00141271|Secondary|Change in Token Motor Task at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition in which a patient places as many of 100 tokens (2 at a time) into a container as they can within 60 seconds. The higher number of tokens placed = patient is better at motor tasks|Baseline to 6 Weeks LOCF|Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.||Number of Tokens||Standard Error|Least Squares Mean
709467|NCT00141271|Secondary|Change in Digit Sequencing Task at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition in which patient sequences digits from lowest to highest. Range of number of correct responses (0-28); higher numbers show better digit sequencing and greater cognition.|Baseline to 6 Weeks LOCF|Intent to treat (ITT) population observed cases||Number Correct||Standard Error|Least Squares Mean
709468|NCT00141271|Secondary|Change in Affective Interference Test, Immediate Recall, Cued-Recall Emotional Words at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition which measures immediate recall (Cued) of 15 emotional words; higher number of words is better recall|Baseline to 6 Weeks LOCF|Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.||words||Standard Error|Least Squares Mean
709469|NCT00141271|Secondary|Change in Affective Interference Test, Immediate Recall, Cued-Recall Non-Emotional Words at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition which measures immediate recall (Cued) of 15 non-emotional words; higher number of words is better recall|Baseline to 6 Weeks LOCF|Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.||words||Standard Error|Least Squares Mean
709470|NCT00141271|Secondary|Change in Affective Interference Test, Immediate Recall, List 3 Non-Emotional Words at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition which measures immediate recall of 15 non-emotional words (List 3); higher number of words is better recall|Baseline to Week 6 LOCF|Intent to treat (ITT) population observed cases||words||Standard Error|Least Squares Mean
709471|NCT00141271|Secondary|Change in Affective Interference Test, Immediate Recall, List 3 Emotional Words at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition which measures immediate recall of 15 emotional words (List 3); higher number of words is better recall|Baseline to Week 6 LOCF|Intent to treat (ITT) population observed cases.Endpoint is LOCF endpoint among Week 1 through Week 6.||words||Standard Error|Least Squares Mean
709472|NCT00141271|Secondary|Change in Affective Interference Test, Immediate Recall, List 2 Non-Emotional Words at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition which measures immediate recall of 15 non-emotional words (List 2); higher number of words is better recall|Baseline to 6 Weeks LOCF|Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.||words||Standard Error|Least Squares Mean
709693|NCT00142935|Primary|HIV Risk Behaviors - Self Report|Participants who self-reported injecting illicit drugs in the past 30 days, based on responses to face-to-face administration of the 6 month interview.|6 month follow-up interviews|||participants|||Number
709473|NCT00141271|Secondary|Change in Affective Interference Test, Immediate Recall, List 2 Emotional Words at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This test is in Brief Assessment of Cognition and measures immediate recall of 15 emotional words (List 2); higher number of words is better recall|Baseline to 6 Weeks LOCF|Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.||words||Standard Error|Least Squares Mean
709474|NCT00141271|Secondary|Change in Affective Interference Test Immediate Recall Non-Emotional Words List 1 at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This instrument measures immediate recall of 15 non-emotional words (List 1); higher number of words is better recall.|Baseline to 6 Weeks LOCF|Intent to treat (ITT) population observed cases||words||Standard Error|Least Squares Mean
709475|NCT00141271|Secondary|Change in Affective Interference Test Immediate Recall List 1 Emotional Words at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition measuring immediate recall of 15 emotional words; higher number of words is better recall.|Baseline to 6 Weeks LOCF|Intent to treat (ITT) population observed cases||words||Standard Error|Least Squares Mean
709476|NCT00141271|Secondary|Change in Verbal Memory Trial Performance Total Score at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This test is part of Brief Assessment of Cognition and measures recall of 15 words repeated 5 times. Range 0-75 words, higher number reflects better recall.|Baseline to 6 Weeks LOCF|Intent to Treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.||words||Standard Error|Least Squares Mean
709477|NCT00141271|Secondary|Change in Sleep Disturbance Factor Score|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This instrument = sum of Scores of 3 items on sleep disturbance within Hamilton Depression Rating Scale (HAM-D). Scale range 0 to 4 with higher scores reflecting greater severity. Total possible is 0 - 12.|Baseline to 6 weeks|ITT Population Observed cases||score on scale||Standard Error|Least Squares Mean
709478|NCT00141271|Secondary|Change in Retardation Factor Scores|Change is observed value at each visit minus baseline value. This instrument = sum of Scores of 4 items on retardation within Hamilton Depression Rating Scale (HAM-D). Scale range is 0 to 4 with higher scores reflecting greater severity. Total possible is 0 - 16.|Baseline to 6 Weeks|||score on scale||Standard Error|Least Squares Mean
709479|NCT00141271|Secondary|Change in Anxiety/Somatizations Factor Total Score|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This instrument = sum of Scores on 6 Items measuring anxiety/somatization within Hamilton Depression Rating Scale (HAM-D). Scale range is 0 to 4, higher scores reflecting greater severity. Total possible 0 - 24.|Baseline to 6 Weeks|ITT Population Observed Cases||score on scale||Standard Error|Least Squares Mean
709480|NCT00141271|Secondary|Change in Bech Melancholia Score|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. Bech Melancholia is the sum of Scores on 6 Items pertaining to melancholia within Hamilton Depression Rating Scale (HAM-D). Scale 0 to 4, higher scores reflecting greater severity;Total possible 0 - 24.|Baseline to 6 Weeks|ITT Population Observed cases||score on scale||Standard Error|Least Squares Mean
709481|NCT00141271|Secondary|Change in Quality of Life, Enjoyment, and Satisfaction Scale (Q-LES-Q) Total Score at Endpoint|Change is observed value at each visit minus baseline value. LOCF endpoint among Week 1 through Week 6. Q-LES-Q: 16-item instrument for patients assessment of his/her quality of life; overall level of satisfaction scale 1=very poor to 5=Very good (1 item re medication can be blank). Total possible score 15 - 80|Baseline to 6 Weeks|ITT Population Observed Cases.n= 142, 137, 139; number of subjects who responded to the scale. Endpoint is LOCF endpoint among Week 1 through Week 6.||score on scale||Standard Error|Least Squares Mean
709482|NCT00141271|Secondary|Change in Sheehan Disability Scale (SDS) Total Score at Endpoint|Observed value each visit minus baseline value. Endpoint is LOCF Week 1 through Week 6. SDS: patient rated measure of disability and impairment in 3 items: work/school, social life, family life/home responsibilities:0(no disruption)- 10(extreme disruption). Total possible is 30.|Baseline to Week 6|ITT Population Observed cases. Endpoint is LOCF endpoint among Week 1 - 6; n= 128, 126, 128; number of subjects who responded to the scale.||score on scale||Standard Error|Least Squares Mean
709483|NCT00141271|Secondary|Response as Measured by CGI-I Score Less Than or Equal to 2|Response each week was yes if CGI-I score less than or equal to 2 (much or very much improved), if not, response was no; Endpoint is LOCF endpoint among Week 1 through Week 6. CGI-I is a Global assessment of improvement in patient's condition. Scale range: 0=not assessed, 1=very much improved, 7=very much worse|Week 1 through Week 6 (endpoint)|"ITT Population Observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.
Not all subjects answered each week."||Participants|||Number
709484|NCT00141271|Secondary|Change in Total Score in Hamilton Depression (HAM-D 25)|Change: observed value at each visit minus baseline value. Endpoint is Last Observation Carried Forward (LOCF) endpoint among Week 1 through Week 6. HAM-D 25: measures the range of depressive symptoms experienced. 25 Items with Scale range:0-2 or 0-4; 0=absent or not depressed, 2 or 4=most severe or extreme.Total possible score is 0 - 72.|Baseline to 6 Weeks|ITT Population Observed Cases. Endpoint is LOCF endpoint among Week 1 through Week 6.||score on scale||Standard Error|Least Squares Mean
709485|NCT00141271|Secondary|Change in Global Clinical Improvement of Symptoms (CGI -I)|Change is observed value at each visit minus baseline value. Overall is average response of Weeks 1 - 6. CGI-I is an instrument for Global assessment of improvement in patient's condition. Scale range: 0=not assessed, 1=very much improved, 7=very much worse|Baseline to 6 weeks|ITT population Observed Cases||score on scale||Standard Error|Least Squares Mean
709486|NCT00141271|Secondary|Change in Assessment of Global Clinical Severity of Symptoms (CGI-S)|Change is observed value at each visit minus baseline value. Overall is average response of Weeks 1 - 6. CGI-S measures severity of patient's mental illness. Scale range: 0 = not assessed, 1 = normal, 7 = among most extremely ill|Baseline to 6 weeks|ITT population Observed Cases||score on scale||Standard Error|Least Squares Mean
709487|NCT00141271|Secondary|Change in Total Score of Young Mania Rating Scale (YMRS)|Change is observed value at each visit minus baseline value. Overall is average response of Weeks 1 - 6. YMRS: 11 item instrument with scale 0 to 4 for 7 items and 0 to 8 for 4 items; 0=normal; 4 or 8=most abnormal. Total possible score is 0 - 60.|Baseline to 6 weeks|ITT Population||score on scale||Standard Error|Least Squares Mean
709488|NCT00141271|Secondary|Change in Hamilton Anxiety Rating (HAM-A)|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. HAM-A is a 14-item scale: rates intensity of psychic anxiety and somatic anxiety on a 5-point severity scale (range: 0=not present to 4=very severe). Total possible score is 0 - 56.|Baseline to 6 weeks|ITT population Observed Cases. Endpoint is LOCF endpoint among Week 1 through Week 6||score on scale||Standard Error|Least Squares Mean
709489|NCT00141271|Secondary|Change in Hamilton Depression (HAM-D 17) Total Score|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. Total score is first 17 items of the HAM-D 25, which measures the range of depressive symptoms patient currently experiencing; scale 0-2 or 0-4; 0=absent or not depressed, 2 or 4=most severe or extreme. Total possible score 0 - 52.|Baseline to 6 weeks|ITT Population Observed Cases. Endpoint is LOCF endpoint among Week 1 through Week 6.||score on scale||Standard Error|Least Squares Mean
709490|NCT00141271|Secondary|Remission as Measured by Hamilton Depression (HAM-D 17) Total Score Less Than or Equal to 7|Response was yes when HAM-D 17 total score was less than or equal to 7 , if not, response was no. Endpoint is LOCF endpoint among Week 1 through Week 6. Total score is first 17 items of the HAM-D 25,which measures the range of depressive symptoms; scale 0-2 or 0-4 with higher scores being more severe. Total possible score 0 - 52.|Baseline to 6 weeks|"ITT Observed Cases.Endpoint is LOCF endpoint among Week 1 through Week 6
Not all subjects answered each week."||Participants|||Number
709491|NCT00141271|Secondary|Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12|Response was Yes if MADRS Total Score was less than, equal to 12, if not, response was no. Endpoint is LOCF endpoint among Week 1 through 6; MADRS is 10-item instrument measuring depression; scale range 0(Normal) and 6(most abnormal)|Baseline to 6 weeks|"ITT Observed Cases.Endpoint is LOCF endpoint among Week 1 through Week 6;
Not all subjects answered each week."||participants|||Number
709492|NCT00141271|Secondary|Change in Global Assessment of Functioning (GAF)at Endpoint, Last Observation Carried Forward (LOCF)|Change is observed value at endpoint minus baseline value. Endpoint is Last Observation Carried Forward (LOCF) endpoint among Week 1 - 6; GAF is used to assess global psychological, social, & occupational functioning; 100=normal and 0=greatest abnormality|Baseline, 6 Weeks LOCF|Intent to treat (ITT) population observed cases, Last Observation Carried Forward (LOCF).||score on scale||Standard Error|Least Squares Mean
709493|NCT00141271|Secondary|Response Greater Than or Equal to 50 Percent Decrease From Baseline in Hamilton Depression Rating Scale (HAM-D 17) Total Score|Participants with greater than or equal to 50 percent decrease from baseline in HAMD-17 total score responded yes; others responded no. Endpoint is LOCF endpoint among Week 1 - 6; Total score is first 17 items of HAM-D 25: measures range of depressive symptoms; scale 0-2 or 0-4 with higher scores being more severe. Total possible score 0 - 52.|Baseline to 6 weeks|"Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6
Not all subjects answered each Week."||participants|||Number
709494|NCT00141271|Secondary|Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score|Participants with MADRS Total Score greater or equal to 50 percent decrease from baseline responded yes; others responded no. Endpoint is last observation carried forward (LOCF) among Week 1 - Week 6; MADRS is 10-item instrument measuring depression; scale range 0(Normal) and 6 (most abnormal). Total possible score is 0 - 60|Baseline to 6 weeks|"Intent to treat (ITT) population observed cases.
Not all subjects answered at each Week"||Participants|||Number
709495|NCT00141271|Primary|Change in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score|Change is observed value at each visit minus baseline value. Overall is average response of Weeks 1 - 6. MADRS is 10-item instrument measuring depression; scale 0(Normal) and 6(most abnormal). Total possible score is 0 - 60.|Baseline to 6 weeks|Intent to treat (ITT) population observed cases||score on scale||Standard Error|Least Squares Mean
709496|NCT00141297|Primary|Correlation of Cyclin-dependent Kinases 4 and 6 (Cdk4/6) With Tumor Response|Phosphorylation of the retinoblastoma (Rb) protein by Cdk4/6 is typically required for human cancer cell proliferation. Tumor biopsies were to be performed, to demonstrate inhibition of Cdk4/6 based on reduction in phosphorylated Rb (p-Rb) in tumor tissue, in correlation with tumor response.|Baseline, C1D1, C1D8, C1D15, C1D22, thereafter Day 1, 8, 15, and 22 of every other cycle up to end of treatment (up to Cycle 93)|Data was reported in individual participant listings and not summarized due to change in planned analysis, where baseline and post-baseline tumor biopsies for biomarkers were no longer required and were not obtained for all participants.|||||
709497|NCT00141297|Primary|Correlation of Cyclin-dependent Kinases 4 and 6 (Cdk4/6) With Exposure|Phosphorylation of the retinoblastoma (Rb) protein by Cdk4/6 is typically required for human cancer cell proliferation. Tumor biopsies were to be performed, to demonstrate inhibition of Cdk4/6 based on reduction in phosphorylated Rb (p-Rb) in tumor tissue, in correlation with PD 0322991 exposure.|Baseline, C1D1, C1D8, C1D15, C1D22, thereafter Day 1, 8, 15, and 22 of every other cycle up to end of treatment (up to Cycle 93)|Data was reported in individual participant listings and not summarized due to change in planned analysis, where baseline and post-baseline tumor biopsies for biomarkers were no longer required and were not obtained for all participants.|||||
709498|NCT00141297|Primary|Correlation of Cyclin-dependent Kinases 4 and 6 (Cdk4/6) With PD 0322991 Dose|Phosphorylation of the retinoblastoma (Rb) protein by Cdk4/6 is typically required for human cancer cell proliferation. Tumor biopsies were to be performed, to demonstrate inhibition of Cdk4/6 based on reduction in phosphorylated Rb (p-Rb) in tumor tissue, in correlation with respect to PD 0322991 dose.|Baseline, C1D1, C1D8, C1D15, C1D22, thereafter Day 1, 8, 15, and 22 of every other cycle up to end of treatment (up to Cycle 93)|Data was reported in individual participant listings and not summarized due to change in planned analysis, where baseline and post-baseline tumor biopsies for biomarkers were no longer required and were not obtained for all participants.|||||
709499|NCT00141297|Primary|Inhibition of Cyclin-dependent Kinases 4 and 6 (Cdk4/6) Based on Phosphorylated Retinoblastoma (p-Rb) in Tumor Tissue|Phosphorylation of the retinoblastoma (Rb) protein by Cdk4/6 is typically required for human cancer cell proliferation. Tumor biopsies were to be performed, to demonstrate inhibition of Cdk4/6 based on reduction in phosphorylated Rb (p-Rb) in tumor tissue and p-Rb levels (fold decrease) were to be reported.|Baseline, C1D1, C1D8, C1D15, C1D22, thereafter Day 1, 8, 15, and 22 of every other cycle up to end of treatment (up to Cycle 93)|Data was reported in individual participant listings and not summarized due to change in planned analysis, where baseline and post-baseline tumor biopsies for biomarkers were no longer required and were not obtained for all participants.|||||
709500|NCT00141297|Primary|Number of Participants With Best Response|Number of participants with best response. Complete response (CR): disappearance of all target and non-target lesions. Partial Response (PR): >=30% decrease in sum of longest diameter (LD) of lesions taking as reference baseline sum LD and no unequivocal progression in non-target lesions. Progressive disease (PD): >=20% increase in sum of LD of lesions taking as a reference smallest sum of the LD since treatment start, or the appearance of >=1 new lesion or unequivocal progression of existing non-target lesions. Stable disease (SD): neither shrinkage for PR nor increase for PD taking as reference smallest sum of LD since treatment start. SD was assessed following the first 2 cycles of treatment (>=2 cycles), 4 cycles of treatment (>=4 cycles), and 10 cycles of treatment (>=10 cycles). Participants may be reported in more than 1 category of SD. Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response.|Baseline up to end of treatment, assessed at C1D1, C1D8, C1D15, C1D22, thereafter Day 1, 8, 15, and 22 of every other cycle up to end of treatment (up to Cycle 93)|Modified Full Analysis Set included all enrolled participants who received at least 1 dose of study medication in Cycle 1 and completed a post-treatment response assessment.||participants|||Number
709501|NCT00141297|Primary|Percent Dose Recovered Unchanged (Percent Ae) in Urine: Food Effect|The percent Ae is defined in Outcome Measure 44. To determine impact of food (specifically high-fat meal) on PD 0332991 PK, participants were tested under fed and fasted conditions in crossover fashion. Each participant served as their own control. In crossover fashion first dose was administered under either fed (high-fat meal) or fasted (10-hour fast) condition on Day 1 of Cycle 1 and 2. First 6 participants were tested under fed (on C1D1) followed by fasted (on C2D1) conditions, next 6 participants were tested under fasted (on C1D1) followed by fed (on C2D1) conditions. Only participants in PD 0332991 200 mg (14/21 days) and 125 mg (21/28 days) groups participated in food effect crossover and results were to be reported as per fed and fasted conditions. High-fat meal was composed of around 800 to 1000 calories total, with fat composing around 50% of total caloric content.|Hour 0 (pre-dose) to 10 hours post-dose on C1D1|Data was not collected because urine PK was not planned to be analyzed by food effect, as per protocol.|||||
709502|NCT00141297|Primary|Percent Dose Recovered Unchanged in Urine (Percent Ae): Single Dose|Percent of dose recovered unchanged in urine over the 10 hour collection interval=100*(Ae divided by dose). Ae is the cumulative amount of drug recovered unchanged in urine over the 10 hour collection interval. Cumulative amount was calculated as sum of urine drug concentration in sample volume for each collection interval.|Hour 0 (pre-dose) to 10 hours post-dose on C1D1|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day. Here “N” (number of participants analyzed) signifies participant who were evaluable for this outcome measure.||percentage of dose||Standard Deviation|Mean
709503|NCT00141297|Primary|Cumulative Amount of Drug Recovered Unchanged in the Urine (Ae): Food Effect|The Ae is defined in Outcome Measure 42. To determine impact of food (specifically high-fat meal) on PD 0332991 PK, participants were tested under fed and fasted conditions in crossover fashion. Each participant served as their own control. In crossover fashion first dose was administered under either fed (high-fat meal) or fasted (10-hour fast) condition on Day 1 of Cycle 1 and 2. First 6 participants were tested under fed (on C1D1) followed by fasted (on C2D1) conditions, next 6 participants were tested under fasted (on C1D1) followed by fed (on C2D1) conditions. Only participants in PD 0332991 200 mg (14/21 days) and 125 mg (21/28 days) groups participated in food effect crossover and results were to be reported as per fed and fasted conditions. High-fat meal was composed of around 800 to 1000 calories total, with fat composing around 50% of total caloric content.|Hour 0 (pre-dose) to 10 hours post-dose on C1D1|Data was not collected because urine PK was not planned to be analyzed by food effect, as per protocol.|||||
709504|NCT00141297|Primary|Cumulative Amount of Drug Recovered Unchanged in the Urine (Ae): Single Dose|Ae is the cumulative amount of drug recovered unchanged in urine over the 10 hour collection interval. Cumulative amount was calculated as sum of urine drug concentration in sample volume for each collection interval. Urine PK analysis was performed only in the MTD/RP2D groups (125 mg [21/28 Days] and 200 mg [14/21 Days]).|Hour 0 (pre-dose) to 10 hours post-dose on C1D1|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day. Here “N” (number of participants analyzed) signifies participant who were evaluable for this outcome measure.||microgram (mcg)||Standard Deviation|Mean
709505|NCT00141297|Primary|Terminal Phase Rate Constant [Lambda (z)] on Day 1: Food Effect|Terminal phase rate constant: absolute value of slope of a linear regression during terminal phase of natural-logarithm transformed concentration-time profile. To determine impact of food (specifically high-fat meal) on PD 0332991 PK, participants were tested under fed and fasted conditions in crossover fashion. Each participant served as their own control. In crossover fashion first dose was administered under either fed (high-fat meal) or fasted (10-hour fast) condition on Day 1 of Cycle 1 and 2. First 6 participants were tested under fed (on C1D1) followed by fasted (on C2D1) conditions, next 6 participants were tested under fasted (on C1D1) followed by fed (on C2D1) conditions. Only participants in PD 0332991 200 mg (14/21 days) and 125 mg (21/28 days) groups participated in food effect crossover and results were to be reported as per fed and fasted conditions. High-fat meal was composed of around 800 to 1000 calories total, with fat composing around 50% of total caloric content.|Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D1, C2D1|It was not possible to calculate the data as the calculation required the slope of terminal elimination phase and the PK sampling was insufficient to characterize the terminal elimination phase.|||||
709506|NCT00141297|Primary|Terminal Phase Rate Constant [Lambda (z)] on Day 14/21 Dose-Corrected to 125 mg: Multiple Dose|Terminal phase rate constant is the absolute value of the slope of a linear regression during the terminal phase of the natural-logarithm transformed concentration-time profile. The mean lambda (z) for 200 mg dose group (dose corrected to 125 mg) on Cycle 1 Day 14 (C1D14) and 125 mg dose group on Cycle 1 Day 21 (C1D21) was calculated. Only participants from 125 mg and 200 mg dose groups were reported.|Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D21 for participants receiving 125 mg (21/28 Days) and Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D14 for participants receiving 200 mg (14/21 Days)|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day. Here “N” (number of participants analyzed) signifies participant who were evaluable for this outcome measure.||1/hour||Standard Deviation|Mean
711117|NCT00167245|Secondary|Days Abstinent From Drinking and Frequency of Heavy Drinking Days as Measured by the Time Line Follow-Back During the Follow-up Period After Discontinuing Medication, Compared to Placebo-treated Subjects.||12 weeks||||||
709507|NCT00141297|Primary|Terminal Phase Rate Constant [Lambda (z)] on Day 8: Multiple Dose|Terminal phase rate constant is the absolute value of the slope of a linear regression during the terminal phase of the natural-logarithm transformed concentration-time profile.|Hour 0 (pre-dose), 1, 2, 4, 7, and 10 hours post-dose on Day 8 of Cycle 1 (C1D8)|It was not possible to calculate the data as the calculation required the slope of terminal elimination phase and the PK sampling was insufficient to characterize the terminal elimination phase.|||||
709508|NCT00141297|Primary|Terminal Phase Rate Constant [Lambda (z)] on Day 1: Single Dose|Terminal phase rate constant is the absolute value of the slope of a linear regression during the terminal phase of the natural­-logarithm transformed concentration-­time profile.|Hour 0 (pre-dose), 1, 2, 4, 7, and 10 hours post-dose on Day 1 of Cycle 1 (C1D1)|It was not possible to calculate data as the calculation required the slope of terminal elimination phase and the PK sampling was insufficient to characterize the terminal elimination phase|||||
709509|NCT00141297|Primary|Accumulation Ratio (Rac) on Day 14/21 Dose-Corrected to 125 mg: Multiple Dose|Rac at Day 14/21 = AUC (0-tau) at Day 14/21 divided by AUC (0-tau) at Day 1. The mean Rac for 200 mg dose group (dose corrected to 125 mg) on Cycle 1 Day 14 (C1D14) and 125 mg dose group on Cycle 1 Day 21 (C1D21) was calculated. Only participants from 125 mg and 200 mg dose groups were reported.|Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D21 for participants receiving 125 mg (21/28 Days) and Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D14 for participants receiving 200 mg (14/21 Days)|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day. Here “N” (number of participants analyzed) signifies participant who were evaluable for this outcome measure.||ratio||Standard Deviation|Mean
709510|NCT00141297|Primary|Accumulation Ratio (Rac) on Day 8: Multiple Dose|Rac at Day 8 = AUC (0-tau) at Day 8 divided by AUC (0-tau) at Day 1.|Hour 0 (pre-dose), 1, 2, 4, 7, 10, and 24 hours post-dose on C1D1 and C1D8|It was not possible to calculate data for this outcome measure because calculation was dependent on the linear regression of data points collected during the terminal phase and the PK sampling was insufficient to characterize the terminal phase, which is needed for the calculation of the Rac.|||||
709511|NCT00141297|Primary|Apparent Volume of Distribution (Vz/F) on Day 1: Food Effect|Volume of distribution: theoretical volume in which total amount of drug would need to be uniformly distributed to produce desired plasma concentration. To determine impact of food (specifically high-fat meal) on PD 0332991 PK, participants were tested under fed and fasted conditions in crossover fashion. Each participant served as their own control. In crossover fashion first dose was administered under either fed (high-fat meal) or fasted (10-hour fast) condition on Day 1 of Cycle 1 and 2. First 6 participants were tested under fed (on C1D1) followed by fasted (on C2D1) conditions, next 6 participants were tested under fasted (on C1D1) followed by fed (on C2D1) conditions. Only participants in PD 0332991 200 mg (14/21 days) and 125 mg (21/28 days) groups participated in food effect crossover and results were to be reported as per fed and fasted conditions. High-fat meal was composed of around 800 to 1000 calories total, with fat composing around 50% of total caloric content.|Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D1, C2D1|It was not possible to calculate data for this outcome measure because calculation was dependent on the linear regression of data points collected during the terminal phase and the PK sampling was insufficient to characterize the terminal phase, which is needed for the calculation of the Vz/F.|||||
709512|NCT00141297|Primary|Apparent Volume of Distribution (Vz/F) on Day 14/21 Dose-Corrected to 125 mg: Multiple Dose|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed. The mean Vz/F for 200 mg dose group (dose corrected to 125 mg) on Cycle 1 Day 14 (C1D14) and 125 mg dose group on Cycle 1 Day 21 (C1D21) was calculated. Only participants from 125 mg and 200 mg dose groups were reported.|Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D21 for participants receiving 125 mg (21/28 Days) and Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D14 for participants receiving 200 mg (14/21 Days)|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day. Here “N” (number of participants analyzed) signifies participant who were evaluable for this outcome measure.||liter||Standard Deviation|Mean
709513|NCT00141297|Primary|Apparent Volume of Distribution (Vz/F) on Day 8: Multiple Dose|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|Hour 0 (pre-dose), 1, 2, 4, 7, and 10 hours post-dose on Day 8 of Cycle 1 (C1D8)|It was not possible to calculate data for this outcome measure because calculation was dependent on the linear regression of data points collected during the terminal phase and the PK sampling was insufficient to characterize the terminal phase, which is needed for the calculation of the Vz/F.|||||
709514|NCT00141297|Primary|Apparent Volume of Distribution (Vz/F) on Day 1: Single Dose|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|Hour 0 (pre-dose), 1, 2, 4, 7, and 10 hours post-dose on Day 1 of Cycle 1 (C1D1)|It was not possible to calculate data for this outcome measure because calculation was dependent on the linear regression of data points collected during the terminal phase and the PK sampling was insufficient to characterize the terminal phase, which is needed for the calculation of the Vz/F.|||||
709522|NCT00141297|Primary|Area Under the Curve From Time Zero to End of the Dosing Interval [AUC(0 to Tau)] on Day 14/21 Dose-Corrected to 125 mg: Multiple Dose|Area under the curve from time zero to end of the dosing interval (24 hours) [AUC (0-tau)]. The mean AUC (0-tau) for 200 mg dose group (dose corrected to 125 mg) on Cycle 1 Day 14 (C1D14) and 125 mg dose group on Cycle 1 Day 21 (C1D21) was calculated. Only participants from 125 mg and 200 mg dose groups were reported.|Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D21 for participants receiving 125 mg (21/28 Days) and Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D14 for participants receiving 200 mg (14/21 Days)|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day. Here “N” (number of participants analyzed) signifies participant who were evaluable for this outcome measure.||ng*hour/mL||Standard Deviation|Mean
711118|NCT00167245|Primary|Number of Heavy Drinking Days|Heavy drinking days, defined as more than 4 standard drinks for men and 3 standard drinks for women|13 weeks|||number of heavy drinking days||Standard Error|Mean
709515|NCT00141297|Primary|Apparent Oral Clearance (CL/F) on Day 1: Food Effect|Clearance of a drug is a measure of rate at which a drug is metabolized or eliminated by normal biological processes. To determine impact of food (specifically high-fat meal) on PD 0332991 PK, participants were tested under fed and fasted conditions in crossover fashion. Each participant served as their own control. In crossover fashion first dose was administered under either fed (high-fat meal) or fasted (10-hour fast) condition on Day 1 of Cycle 1 and 2. First 6 participants were tested under fed (on C1D1) followed by fasted (on C2D1) conditions, next 6 participants were tested under fasted (on C1D1) followed by fed (on C2D1) conditions. Only participants in PD 0332991 200 mg (14/21 days) and 125 mg (21/28 days) groups participated in food effect crossover and results were to be reported as per fed and fasted conditions. High-fat meal was composed of around 800 to 1000 calories total, with fat composing around 50% of total caloric content.|Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D1, C2D1|It was not possible to calculate data for this outcome measure because calculation was dependent on the linear regression of data points collected during the terminal phase and the PK sampling was insufficient to characterize the terminal phase, which is needed for the calculation of the CL/F.|||||
709516|NCT00141297|Primary|Apparent Oral Clearance (CL/F) on Day 14/21 Dose-Corrected to 125 mg: Multiple Dose|Clearance of a drug is a measure of rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. The mean CL/F for 200 mg dose group (dose corrected to 125 mg) on Cycle 1 Day 14 (C1D14) and 125 mg dose group on Cycle 1 Day 21 (C1D21) was calculated. Only participants from 125 mg and 200 mg dose groups were reported.|Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D21 for participants receiving 125 mg (21/28 Days) and Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D14 for participants receiving 200 mg (14/21 Days)|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day. Here “N” (number of participants analyzed) signifies participant who were evaluable for this outcome measure.||liter/hour||Standard Deviation|Mean
709517|NCT00141297|Primary|Apparent Oral Clearance (CL/F) on Day 8: Multiple Dose|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Hour 0 (pre-dose), 1, 2, 4, 7, and 10 hours post-dose on Day 8 of Cycle 1 (C1D8)|It was not possible to calculate data for this outcome measure because calculation was dependent on the linear regression of data points collected during the terminal phase and the PK sampling was insufficient to characterize the terminal phase, which is needed for the calculation of the CL/F.|||||
709518|NCT00141297|Primary|Apparent Oral Clearance (CL/F) on Day 1: Single Dose|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Hour 0 (pre-dose), 1, 2, 4, 7, and 10 hours post-dose on Day 1 of Cycle 1 (C1D1)|It was not possible to calculate data for this outcome measure because calculation was dependent on the linear regression of data points collected during the terminal phase and the PK sampling was insufficient to characterize the terminal phase, which is needed for the calculation of the CL/F.|||||
709519|NCT00141297|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] on Day 1: Food Effect|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). To determine impact of food (specifically high-fat meal) on PD 0332991 PK, participants were tested under fed and fasted conditions in crossover fashion. Each participant served as their own control. In crossover fashion first dose was administered under either fed (high-fat meal) or fasted (10-hour fast) condition on Day 1 of Cycle 1 and 2. First 6 participants were tested under fed (on C1D1) followed by fasted (on C2D1) conditions, next 6 participants were tested under fasted (on C1D1) followed by fed (on C2D1) conditions. Only participants in PD 0332991 200 mg (14/21 days) and 125 mg (21/28 days) groups participated in food effect crossover and results were to be reported as per fed and fasted conditions. High-fat meal was composed of around 800 to 1000 calories total, with fat composing around 50% of total caloric content.|Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D1, C2D1|It was not possible to calculate data for this outcome measure because calculation was dependent on the linear regression of data points collected during the terminal phase and the PK sampling was insufficient to characterize the terminal phase, which is needed for the calculation of the AUC (0 - ∞).|||||
709520|NCT00141297|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] on Day 8: Multiple Dose|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Hour 0 (pre-dose), 1, 2, 4, 7, and 10 hours post-dose on Day 8 of Cycle 1 (C1D8)|It was not possible to calculate data for this outcome measure because calculation was dependent on the linear regression of data points collected during the terminal phase and the PK sampling was insufficient to characterize the terminal phase, which is needed for the calculation of the AUC (0 - ∞).|||||
709521|NCT00141297|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] on Day 1: Single Dose|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Hour 0 (pre-dose), 1, 2, 4, 7, and 10 hours post-dose on Day 1 of Cycle 1 (C1D1)|It was not possible to calculate data for this outcome measure because calculation was dependent on the linear regression of data points collected during the terminal phase and the PK sampling was insufficient to characterize the terminal phase, which is needed for the calculation of the AUC (0 - ∞).|||||
709761|NCT00150969|Secondary|Percent Change in Bone Mineral Density (BMD) at the Ultra-distal Radius Between Treatment Arms.|BMD was measured yearly on one scanner at UHN using DEXA Hologic 4500A densitometer|0 to 24 months|For our 2 year BMD anlayses we included all 440 women based on intention to treat using last observation carried forward for missing data.||percentage change in BMD||Standard Deviation|Mean
709523|NCT00141297|Primary|Area Under the Curve From Time Zero to the Last Measured Concentration (AUClast) on Day 1: Food Effect|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). To determine impact of food (specifically high-fat meal) on PD 0332991 PK, participants were tested under fed and fasted conditions in crossover fashion. Each participant served as their own control. In crossover fashion first dose was administered under either fed (high-fat meal) or fasted (10-hour fast) condition on Day 1 of Cycle 1 and 2. First 6 participants were tested under fed (on C1D1) followed by fasted (on C2D1) conditions, next 6 participants were tested under fasted (on C1D1) followed by fed (on C2D1) conditions. Only participants in PD 0332991 200 mg (14/21 days) and 125 mg (21/28 days) groups participated in food effect crossover and results are reported as per fed and fasted conditions. High-fat meal was composed of around 800 to 1000 calories total, with fat composing around 50% of total caloric content.|Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D1, C2D1|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day. Here “N” (number of participants analyzed) signifies participant who were evaluable for this outcome measure.||ng*hour/mL||Standard Deviation|Mean
709524|NCT00141297|Primary|Area Under the Curve From Time Zero to the Last Measured Concentration (AUClast) on Day 14/21 Dose-Corrected to 125 mg: Multiple Dose|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). The mean AUClast for 200 mg dose group (dose corrected to 125 mg) on Cycle 1 Day 14 (C1D14) and 125 mg dose group on Cycle 1 Day 21 (C1D21) was calculated. Only participants from 125 mg and 200 mg dose groups were reported.|Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D21 for participants receiving 125 mg (21/28 Days) and Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D14 for participants receiving 200 mg (14/21 Days)|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day. Here “N” (number of participants analyzed) signifies participant who were evaluable for this outcome measure.||ng*hour/mL||Standard Deviation|Mean
709525|NCT00141297|Primary|Area Under the Curve From Time Zero to the Last Measured Concentration (AUClast) on Day 8: Multiple Dose|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).|Hour 0 (pre-dose), 1, 2, 4, 7, and 10 hours post-dose on Day 8 of Cycle 1 (C1D8)|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day. Here “N” (number of participants analyzed) signifies participant who were evaluable for this outcome measure.||ng*hour/mL||Standard Deviation|Mean
709526|NCT00141297|Primary|Area Under the Curve From Time Zero to the Last Measured Concentration (AUClast) on Day 1: Single Dose|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).|Hour 0 (pre-dose), 1, 2, 4, 7, and 10 hours post-dose on Day 1 of Cycle 1 (C1D1)|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day.||nanogram*hour/milliliter (ng*hour/mL)||Standard Deviation|Mean
709527|NCT00141297|Primary|Terminal Half-life (t½ ) on Day 1: Food Effect|To determine impact of food (specifically high-fat meal) on PD 0332991 PK, participants were tested under fed and fasted conditions in crossover fashion. Each participant served as their own control. In crossover fashion first dose was administered under either fed (high-fat meal) or fasted (10-hour fast) condition on Day 1 of Cycle 1 and 2. First 6 participants were tested under fed (on C1D1) followed by fasted (on C2D1) conditions, next 6 participants were tested under fasted (on C1D1) followed by fed (on C2D1) conditions. Only participants in PD 0332991 200 mg (14/21 days) and 125 mg (21/28 days) groups participated in food effect crossover and results were to be reported as per fed and fasted conditions. High-fat meal was composed of around 800 to 1000 calories total, with fat composing around 50% of total caloric content.|Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D1, C2D1|It was not possible to calculate data for t½ as the calculation required the slope of terminal elimination phase and the PK sampling was insufficient to characterize the terminal elimination phase, which is needed for the calculation of the t½.|||||
709528|NCT00141297|Primary|Terminal Half-life (t½) on Day 14/21 Dose-Corrected to 125 mg: Multiple Dose|Terminal half-life is the time measured for the plasma concentration to decrease by one half. The mean t1/2 for 200 mg dose group (dose corrected to 125 mg) on Cycle 1 Day 14 (C1D14) and 125 mg dose group on Cycle 1 Day 21 (C1D21) was calculated. Only participants from 125 mg and 200 mg dose groups were reported.|Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D21 for participants receiving 125 mg (21/28 Days) and Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D14 for participants receiving 200 mg (14/21 Days)|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day. Here “N” (number of participants analyzed) signifies participant who were evaluable for this outcome measure.||hours||Standard Deviation|Mean
709529|NCT00141297|Primary|Terminal Half-life (t½ ) on Day 8: Multiple Dose|Terminal half-life is the time measured for the plasma concentration to decrease by one half.|Hour 0 (pre-dose), 1, 2, 4, 7, and 10 hours post-dose on Day 8 of Cycle 1 (C1D8)|It was not possible to calculate data for t½ as the calculation required the slope of terminal elimination phase and the PK sampling was insufficient to characterize the terminal elimination phase, which is needed for the calculation of the t½.|||||
709530|NCT00141297|Primary|Terminal Half-life (t½ ) on Day 1: Single Dose|Terminal half-life is the time measured for the plasma concentration to decrease by one half.|Hour 0 (pre-dose), 1, 2, 4, 7, and 10 hours post-dose on Day 1 of Cycle 1 (C1D1)|It was not possible to calculate data for t½ as the calculation required the slope of terminal elimination phase and the PK sampling was insufficient to characterize the terminal elimination phase, which is needed for the calculation of the t½.|||||
709541|NCT00141297|Primary|Number of Participants With Treatment Emergent Adverse Events Categorized by Severity|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. For clinical description of nature (severity) of AEs, AEs were grades as: Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; and Grade 5: death related to AE. AEs during Cycle 1 and AEs post Cycle 1 are reported separately.|Cycle 1, Cycle 2 up to 28 days after end of treatment (up to Cycle 93)|FAS included all enrolled participants who received at least one dose of study medication.||participants|||Number
711245|NCT00176488|Secondary|Biological Response to Epirubicin and Vinorelbine Administered in Patients With Breast Cancer in Sequential Tumor Biopsies and Peripheral Blood Mononuclear Cells.||10 years|Study was closed prematurely and insufficient data was collected.|||||
709531|NCT00141297|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 1: Food Effect|To determine impact of food (specifically high-fat meal) on PD 0332991 PK, participants were tested under fed and fasted conditions in crossover fashion. Each participant served as their own control. In crossover fashion first dose was administered under either fed (high-fat meal) or fasted (10-hour fast) condition on Day 1 of Cycle 1 and 2. First 6 participants were tested under fed (on C1D1) followed by fasted (on C2D1) conditions, next 6 participants were tested under fasted (on C1D1) followed by fed (on C2D1) conditions. Only participants in PD 0332991 200 mg (14/21 days) and 125 mg (21/28 days) groups participated in food effect crossover and results are reported as per fed and fasted conditions. High-fat meal was composed of around 800 to 1000 calories total, with fat composing around 50% of total caloric content.|Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D1, C2D1|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day. Here “N” (number of participants analyzed) signifies participant who were evaluable for this outcome measure.||hours||Full Range|Median
709532|NCT00141297|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 14/21 Dose-Corrected to 125 mg: Multiple Dose|The median Tmax for 200 mg dose group (dose corrected to 125 mg) on Cycle 1 Day 14 (C1D14) and 125 mg dose group on Cycle 1 Day 21 (C1D21) was calculated. Only participants from 125 mg and 200 mg dose groups were reported.|Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D21 for participants receiving 125 mg (21/28 Days) and Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D14 for participants receiving 200 mg (14/21 Days)|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day. Here “N” (number of participants analyzed) signifies participant who were evaluable for this outcome measure.||hours||Full Range|Median
709533|NCT00141297|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 8: Multiple Dose||Hour 0 (pre-dose), 1, 2, 4, 7, and 10 hours post-dose on Day 8 of Cycle 1 (C1D8)|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day. Here “N” (number of participants analyzed) signifies participant who were evaluable for this outcome measure.||hours||Full Range|Median
709534|NCT00141297|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 1: Single Dose||Hour 0 (pre-dose), 1, 2, 4, 7, and 10 hours post-dose on Day 1 of Cycle 1 (C1D1)|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day.||hours||Full Range|Median
709535|NCT00141297|Primary|Maximum Observed Plasma Concentration (Cmax) on Day 1: Food Effect|To determine the impact of food (specifically a high-fat meal) on PD 0332991 PK, participants were tested under fed and fasted conditions in crossover fashion. Each participant served as their own control. In this crossover fashion first dose was administered under either fed (high-fat meal) or fasted (10-hour fast) condition on Day 1 of Cycle 1 and 2. The first 6 participants were tested under fed (on C1D1) followed by fasted (on C2D1) conditions, the next 6 participants were tested under fasted (on C1D1) followed by fed (on C2D1) conditions. Only participants in PD 0332991 200 mg (14/21 days) and 125 mg (21/28 days) groups participated in food effect crossover and results are reported as per fed and fasted conditions. The high-fat meal was composed of around 800 to 1000 calories total, with fat composing around 50% of the total caloric content.|Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D1, C2D1|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day. Here “N” (number of participants analyzed) signifies participant who were evaluable for this outcome measure.||ng/mL||Standard Deviation|Mean
709536|NCT00141297|Primary|Maximum Observed Plasma Concentration (Cmax) on Day 14/21 Dose-Corrected to 125 mg: Multiple Dose|The mean Cmax for 200 mg dose group (dose corrected to 125 mg) on Cycle 1 Day 14 (C1D14) and 125 mg dose group on Cycle 1 Day 21 (C1D21) was calculated. Only participants from 125 mg and 200 mg dose groups were reported.|Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D21 for participants receiving 125 mg (21/28 Days) and Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D14 for participants receiving 200 mg (14/21 Days)|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day. Here “N” (number of participants analyzed) signifies participant who were evaluable for this outcome measure.||ng/mL||Standard Deviation|Mean
709537|NCT00141297|Primary|Maximum Observed Plasma Concentration (Cmax) on Day 8: Multiple Dose||Hour 0 (pre-dose), 1, 2, 4, 7, and 10 hours post-dose on Day 8 of Cycle 1 (C1D8)|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day. Here “N” (number of participants analyzed) signifies participant who were evaluable for this outcome measure.||ng/mL||Standard Deviation|Mean
709538|NCT00141297|Primary|Maximum Observed Plasma Concentration (Cmax) on Day 1: Single Dose||Hour 0 (pre-dose), 1, 2, 4, 7, and 10 hours post-dose on Day 1 of Cycle 1 (C1D1)|Pharmacokinetic (PK) analysis set included all participants from FAS who had completed PK blood sampling for at least one day.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
709539|NCT00141297|Primary|Number of Participants Who Died Due to Adverse Event on the Basis of Relatedness to Study Drug|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness [to study drug] was assessed by the investigator (Yes/No).|Baseline up to 30 days after end of treatment (up to Cycle 93)|FAS included all enrolled participants who received at least one dose of study medication.||participants|||Number
709540|NCT00141297|Primary|Number of Participants With Treatment-Related Treatment Emergent Adverse Events|A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs during Cycle 1 and AEs post Cycle 1 are reported separately.|Cycle 1, Cycle 2 up to 28 days after end of treatment (up to Cycle 93)|FAS included all enrolled participants who received at least one dose of study medication.||participants|||Number
709762|NCT00150969|Secondary|Percent Change in Bone Mineral Density (BMD) at the Femoral Neck Between Treatment Arms.|BMD was measured yearly on one scanner at UHN using DEXA Hologic 4500A densitometer|0 to 24 months|For our 2 year BMD anlayses we included all 440 women based on intention to treat using last observation carried forward for missing data.||percentage change in BMD||Standard Deviation|Mean
709542|NCT00141297|Primary|Number of Dose-Limiting Toxicities (DLTs) Categorized as Per the Nature|DLT is defined in Outcome Measure 1. Hematologic (Grade 4 [life-threatening or disabling]) and non-hematologic (Grade 3 [severe], 4 [life-threatening and disabling], 5 [resulting in death]) DLTs are reported separately. A single participant may experience more than one DLT. Both treatment-related and treatment-unrelated DLT events were reported for this outcome measure.|Baseline up to 28 days|FAS included all enrolled participants who received at least one dose of study medication.||DLTs|||Number
709543|NCT00141297|Primary|Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose Level (RP2D)|MTD was defined as the highest dose level studied for which the incidence of first cycle DLT was <33%. Once MTD was determined, it was defined as RP2D. DLT is defined in Outcome Measure 1.|Baseline up to 28 days|FAS included all enrolled participants who received at least one dose of study medication.||milligram|||Number
709544|NCT00141297|Primary|Maximum Administered Dose (MAD)|Three new evaluable participants were to be assessed at each new dose level. The minimum time that these participants were to be followed after starting treatment was 1 cycle (28 or 21 days) before a new dose level could be opened. If none of these 3 participants experienced a DLT, the next higher dose level was to be opened on that schedule. If 1 participant developed a DLT, 3 more evaluable participants were to be enrolled at that dose level; if none of these additional 3 participants developed a DLT, the next higher dose level was to be opened on that schedule. If >=2 participants experienced a first cycle DLT at the same dose level and schedule, that dose level was to be defined as the MAD for that schedule. No additional participants were to be entered at the MAD for that dosing schedule. DLT is defined in Outcome Measure 1.|Baseline up to 28 days|FAS included all enrolled participants who received at least one dose of study medication.||milligram|||Number
709545|NCT00141297|Primary|Number of Participants With Dose-Limiting Toxicities (DLT)|DLT: an adverse event occurring after initiation of PD 0332991 that met any following criteria: 1) Grade 4 hematologic toxicity (platelets less than [<] 25000 per microliter (mcL), absolute neutrophil count [ANC] <500/mcL, hemoglobin [Hb] <6.5 gram per deciliter [g/dL]; 2) ANC <1000/mcL associated with documented infection or fever greater than or equal to (>=) 38.5 degrees Celsius; 3) >=Grade 3 non-hematologic treatment-related toxicity. In an asymptomatic participant, Grade 3 corrected QT (QTc) prolongation (>500 millisecond) (only if persisted with repeat testing and after correction of reversible causes [electrolyte abnormalities or hypoxia]); and 4) Inability to receive next dose of PD 0332991 within 1 week (+/-1 day) of last dose due to lack of hematologic recovery (platelets <50000/mcL, ANC <1000/mcL, and Hb <8.0 g/dL) or due to prolonged non-hematologic toxicities of >=Grade 3 severity. Occurrence of a DLT necessitated immediate interruption of scheduled study treatment.|Baseline up to 28 days|FAS included all enrolled participants who received at least one dose of study medication.||participants|||Number
709546|NCT00141453|Secondary|Reciprocal (1/Serum Creatinine) of Serum Creatinine|The amount of serum creatinine was determined by blood tests periodically during the study. The amount of creatinine is an indication of kidney function. The reciprocal of serum creatinine is used in an equation to determine the change in kidney function from baseline. The reciprocal of the serum creatinine was monitored to detect kidney function changes over duration of the study.|Randomization to 5 years|Full analysis set=566||dL/mg/year||Inter-Quartile Range|Median
709547|NCT00141453|Secondary|The Change in Proteinuria|The median percentage change from baseline value in urinary protein:creatinine ratio|Randomization to 5 years|Full analysis set=566||Median percentage change in ratio|||Number
709548|NCT00141453|Secondary|Number of Participants Experiencing Cardiovascular Composite Outcomes|Number of participants experiencing the first occurence of any of the following: Cardiovascular death; non-fatal stroke; non-fatal myocardial infarction; hospitalization for unstable angina; lower extremity amputation; coronary/carotid/peripheral revascularization.|Within 5 years|Full analysis set=566||participants|||Number
709549|NCT00141453|Primary|Renal Composite Outcomes|first occurrence of any of the following events: Doubling of serum creatinine level; Death; End stage renal disease|Randomization to 5 years|Full analysis set=566||participants|||Number
709550|NCT00141518|Other Pre-specified|EQ-5D Visual Analog Scale (VAS) Score, up to Month 36|The EQ-5D VAS records the participant's self-rated health on a scale from 0-100 where 100 is the 'best imaginable health state' and 0 is the 'worst imaginable health state.'|Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
709551|NCT00141518|Other Pre-specified|EQ-5D Descriptive Systems Summary Index Score, up to Month 36|The EQ-5D is a participant-answered questionnaire scoring 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that essentially attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 to 1.00 with positive change indicating improvement.|Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
709552|NCT00141518|Other Pre-specified|UPDRS Part IV Score, up to Month 36|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. For Part IV, questions are measured on a 5-point scale of 0 (normal or no disease effect) to 4 (maximum negative effect) or 2-point scale (0 or 1). Part IV score is the sum of answers to 'Complications of Therapy' questions, with a score range from 0-23. Higher scores are associated with more disability.|Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
709553|NCT00141518|Other Pre-specified|UPDRS Part III Score, up to Month 36|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. For Parts I-III and Total Score, each question is measured on a 5-point scale of 0 (normal or no disease effect) to 4 (maximum negative effect). Part III score is the sum of answers to 'Motor Examination' questions, with a score range from 0-108. Higher scores are associated with more disability.|Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
709554|NCT00141518|Other Pre-specified|UPDRS Part II Score, up to Month 36|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. For Parts I-III and Total Score, each question is measured on a 5-point scale of 0 (normal or no disease effect) to 4 (maximum negative effect). Part II score is the sum of answers to 'Activities of Daily Living' questions, with a score range from 0-52. Higher scores are associated with more disability.|Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
709555|NCT00141518|Other Pre-specified|UPDRS Part I Score, up to Month 36|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. For Parts I-III and Total Score, each question is measured on a 5-point scale of 0 (normal or no disease effect) to 4 (maximum negative effect). Part I score is the sum of answers to 'Mentation, Behavior and Mood' questions, with a score range from 0-16. Higher scores are associated with more disability.|Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
709556|NCT00141518|Other Pre-specified|UPDRS Total Score up to Month 36|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. For Parts I-III and Total Score, each question is measured on a 5-point scale of 0 (normal or no disease effect) to 4 (maximum negative effect). Part I score is the sum of answers to 'Mentation, Behavior and Mood' questions, with a score range from 0-16. Part II score is the sum of answers to 'Activities of Daily Living' questions, with a score range from 0-52. Part III score is the sum of answers to 'Motor Examination' questions, with a score range from 0-108. Total Score is the sum of the responses to the 31 questions (44 answers) that comprise Parts I-III of the scale, with a score range from 0-176. Higher scores are associated with more disability.|Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
709557|NCT00141518|Secondary|Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36|The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: ‘walking’, ‘satisfied’, ‘dyskinesia’, and ‘off’ and two objectively-measured: ‘tapping’ and ‘spiral’. Each of the items was assessed in the morning and during the day. Drawing impairment was assessed as a spiral score, where the participant is asked to draw a spiral. 1 is worst score, 10 is best.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
709558|NCT00141518|Secondary|Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36|The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: ‘walking’, ‘satisfied’, ‘dyskinesia’, and ‘off’ and two objectively-measured: ‘tapping’ and ‘spiral’. Each of the items was assessed in the morning and during the day. Tapping: Random chase speed’ is defined as the number of correct taps of fields randomly selected by the computer per 20 seconds. ‘Tapping random chase – accuracy’ is the percentage of accurate random chase taps.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||percentage of accurate taps||Standard Deviation|Mean
709565|NCT00141518|Secondary|Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36|The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: ‘walking’, ‘satisfied’, ‘dyskinesia’, and ‘off’ and two objectively-measured: ‘tapping’ and ‘spiral’. Each of the items was assessed in the morning and during the day. ‘Cramps’ scores were 1 (worst) to 5 (best).|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
709559|NCT00141518|Secondary|Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36|The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: ‘walking’, ‘satisfied’, ‘dyskinesia’, and ‘off’ and two objectively-measured: ‘tapping’ and ‘spiral’. Each of the items was assessed in the morning and during the day. Tapping: Random chase speed’ is defined as the number of correct taps of fields randomly selected by the computer per 20 seconds.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||taps/20 seconds||Standard Deviation|Mean
709560|NCT00141518|Secondary|Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36|The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: ‘walking’, ‘satisfied’, ‘dyskinesia’, and ‘off’ and two objectively-measured: ‘tapping’ and ‘spiral’. Each of the items was assessed in the morning and during the day. ‘Tapping at increased speed - accuracy’ is the percentage of accurate taps per all taps on computer-generated fields.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||percentage of accurate taps||Standard Deviation|Mean
709561|NCT00141518|Secondary|Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36|The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: ‘walking’, ‘satisfied’, ‘dyskinesia’, and ‘off’ and two objectively-measured: ‘tapping’ and ‘spiral’. Each of the items was assessed in the morning and during the day. ‘Free tapping’ is defined as ____. ‘Free tapping accuracy’ is the percentage of accurate free taps per 20 seconds(?).|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||percentage of tapping accuracy||Standard Deviation|Mean
709562|NCT00141518|Secondary|Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36|The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: ‘walking’, ‘satisfied’, ‘dyskinesia’, and ‘off’ and two objectively-measured: ‘tapping’ and ‘spiral’. Each of the items was assessed in the morning and during the day. Free tapping is defined as voluntary repetitive finger tapping on computer-generated fields. 'Free tapping speed’ is a count of the number of taps per 20 seconds.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||taps/20 seconds||Standard Deviation|Mean
709563|NCT00141518|Secondary|Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36|The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: ‘walking’, ‘satisfied’, ‘dyskinesia’, and ‘off’ and two objectively-measured: ‘tapping’ and ‘spiral’. Each of the items was assessed in the morning and during the day. ‘Self-assessment’ scores were -3 (Off) to +3 (dyskinetic). ‘Off’ time is when PD symptoms are not adequately controlled by the drug. ‘Dyskinetic’ time is time with involuntary muscle movement. “0” is defined as the normal ON state without dyskinesia (the desired motor state). Everything closer to “0” means improvement, everything more away from “0” means either less mobility (in the negative score) or involuntary movements (dyskinesia, in the positive score).|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
709564|NCT00141518|Secondary|Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36|The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: ‘walking’, ‘satisfied’, ‘dyskinesia’, and ‘off’ and two objectively-measured: ‘tapping’ and ‘spiral’. Each of the items was assessed in the morning and during the day. ‘Satisfied with function’ scores were 1 (worst) to 5 (best).|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
709763|NCT00150969|Primary|Percent Change in Bone Mineral Density (BMD) at the Lumbar Spine (L1-L4) Between Treatment Arms.|BMD was measured yearly on one scanner at UHN using DEXA Hologic 4500A densitometer|0 to 24 months|For our 2 year BMD anlayses we included all 440 women based on intention to treat using last observation carried forward for missing data.||percentage change in BMD||Standard Deviation|Mean
709566|NCT00141518|Secondary|Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36|The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: ‘walking’, ‘satisfied’, ‘dyskinesia’, and ‘off’ and two objectively-measured: ‘tapping’ and ‘spiral’. Each of the items was assessed in the morning and during the day. ‘Dyskinetic time’ is time with involuntary muscle movement. Magnitude scores were 1 (worst) to 5 (best).|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
709567|NCT00141518|Secondary|Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36|The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: ‘walking’, ‘satisfied’, ‘dyskinesia’, and ‘off’ and two objectively-measured: ‘tapping’ and ‘spiral’. Each of the items was assessed in the morning and during the day. ‘Off time’ is when PD symptoms are not adequately controlled by the drug. Magnitude scores were 1 (worst) to 5 (best).|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
709568|NCT00141518|Secondary|Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36|The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: ‘walking’, ‘satisfied’, ‘dyskinesia’, and ‘off’ and two objectively-measured: ‘tapping’ and ‘spiral’. Each of the items was assessed in the morning and during the day. ‘Dyskinetic time’ is time with involuntary muscle movement, and is represented as a percentage of total time of the last __ hours.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||percentage of 'dyskinetic' time||Standard Deviation|Mean
709569|NCT00141518|Secondary|Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36|"The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: ‘walking’, ‘satisfied’, ‘dyskinesia’, and ‘off’ and two objectively-measured: ‘tapping’ and ‘spiral’. Each of the items was assessed in the morning and during the day. On time is when PD symptoms are well controlled by the drug, and is represented as a percentage of total time of the last __ hours."|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||percentage of 'on' time||Standard Deviation|Mean
709570|NCT00141518|Secondary|Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36|"The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: ‘walking’, ‘satisfied’, ‘dyskinesia’, and ‘off’ and two objectively-measured: ‘tapping’ and ‘spiral’. Each of the items was assessed in the morning and during the day. Off time is when PD symptoms are not adequately controlled by the drug, and is represented as a percentage of total time awake per day."|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||percentage of 'off' time||Standard Deviation|Mean
709571|NCT00141518|Secondary|Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36|The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: ‘walking’, ‘satisfied’, ‘dyskinesia’, and ‘off’ and two objectively-measured: ‘tapping’ and ‘spiral’. Each of the items was assessed in the morning and during the day. Walking scores ranged from 1 (worst) to 5 (best).|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
709584|NCT00141518|Secondary|MADRS Lassitude Scores From Baseline to Month 36|MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Lassitude scores rate difficulty in getting started or slowness in initiating and performing everyday activities.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
709572|NCT00141518|Secondary|PDQ-39 Bodily Discomfort Subscale Scores From Baseline to Month 36|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
709573|NCT00141518|Secondary|PDQ-39 Communication Subscale Scores From Baseline to Month 36|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
709574|NCT00141518|Secondary|PDQ-39 Cognition Subscale Scores From Baseline to Month 36|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
709575|NCT00141518|Secondary|PDQ-39 Social Support Subscale Scores From Baseline to Month 36|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
709576|NCT00141518|Secondary|PDQ-39 Stigma Subscale Scores From Baseline to Month 36|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
709583|NCT00141518|Secondary|MADRS Inability to Feel Scores From Baseline to Month 36|MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Inability to Feel scores rate the subjective experience of reduced interest in the surroundings, or activities that normally give pleasure. The ability to react with adequate emotion to circumstances or people is reduced.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
709577|NCT00141518|Secondary|PDQ-39 Emotional Well Being Subscale Scores From Baseline to Month 36|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
709578|NCT00141518|Secondary|PDQ-39 Activities of Daily Living Subscale Scores From Baseline to Month 36|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
709579|NCT00141518|Secondary|PDQ-39 Mobility Subscale Scores From Baseline to Month 36|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
709580|NCT00141518|Secondary|Parkinson’s Disease Questionnaire-39 (PDQ-39) Summary Index Scores From Baseline to Month 36|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The PDQ-39 Summary Index is the sum of all answers divided by the highest score possible, which is multiplied by 100 to put the score on a 0-100 scale. Higher scores are associated with more severe symptoms.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
709581|NCT00141518|Secondary|MADRS Suicidal Thoughts Scores From Baseline to Month 36|MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Suicidal Thoughts scores rate the feeling that life is not worth living, that a natural death would be welcome, suicidal thoughts, and preparations for suicide.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
709582|NCT00141518|Secondary|MADRS Pessimistic Thoughts Scores From Baseline to Month 36|MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Pessimistic Thoughts scores rate thoughts of guilt, inferiority, self-reproach, sinfulness, remorse and ruin.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
709624|NCT00141778|Secondary|Time to Tracheal Extubation|It is the time in minutes that it took to extubate the patient after surgery.|It is the time (in minutes) from admission to the ICU until tracheal extubation|The intention-to-treat analysis included all patients who received any study medication.||minutes||Standard Deviation|Mean
709625|NCT00141778|Secondary|Hypokalemia|Percentage of patients who had a serum potassium concentrations <3.5 milliequivalents (mEq)/L|Measured until the time of hospital discharge, which was an average of 5.7 to 6.8 days depending on the treatment arm.|||percentage of patients|||Number
709585|NCT00141518|Secondary|MADRS Concentration Difficulties Scores From Baseline to Month 36|MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Concentration Difficulties scores rate difficulties in collecting one's thoughts mounting to an incapacitating lack of concentration.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
709586|NCT00141518|Secondary|MADRS Reduced Appetite Scores From Baseline to Month 36|MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Reduced Appetite scores rate the feeling of a loss of appetite compared with when-well. Rate by loss of desire for food or the need to force oneself to eat.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
709587|NCT00141518|Secondary|MADRS Reduced Sleep Scores From Baseline to Month 36|MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Reduced Sleep scores rate the experience of reduced duration or depth of sleep compared to the participant's own normal pattern when well.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
709588|NCT00141518|Secondary|MADRS Inner Tension Scores From Baseline to Month 36|MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Inner Tension scores rate feelings of ill-defined discomfort, edginess, inner turmoil, mental tension mounting to either panic, dread or anguish.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
709589|NCT00141518|Secondary|MADRS Apparent Sadness Scores From Baseline to Month 36|MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Apparent sadness scores rate despondency, gloom and despair (more than just ordinary transient low spirits), reflected in speech, facial expression, and posture.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
709590|NCT00141518|Secondary|MADRS Reported Sadness Scores From Baseline to Month 36|MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Reported Sadness scores rate depressed mood, regardless of whether it is reflected in appearance or not, and includes low spirits, despondency or the feeling of being beyond help and without hope.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
709591|NCT00141518|Secondary|Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores From Baseline to Month 36|MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Total score ranges from 0 (no depression) to 60 (severely depressed).|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
709592|NCT00141518|Secondary|MMSE Language Subscale Scores From Baseline to Month 36|The MMSE is used to assess orientation, attention, immediate and short term recall, language, and ability to follow simple verbal and written commands. The Language subscale results in a total possible score of 0 to 9, with higher scores indicating better function.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
709626|NCT00141778|Secondary|Hypotension|Percentage of patients with hypotension defined as a systolic blood pressure <90 mmHg and/or prolonged requirement for vasopressor use.|Measured during and after surgery, until discharge, from 5.7 to 6.8 days on average.|The intention-to-treat analysis included anyone who had received any medication.||percentage of patients|||Number
709593|NCT00141518|Secondary|MMSE Recall Subscale Scores From Baseline to Month 36|The MMSE is used to assess orientation, attention, immediate and short term recall, language, and ability to follow simple verbal and written commands. The Recall subscale results in a total possible score of 0 to 3, with higher scores indicating better function.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
709594|NCT00141518|Secondary|MMSE Attention and Calculation Subscale Scores From Baseline to Month 36|The MMSE is used to assess orientation, attention, immediate and short term recall, language, and ability to follow simple verbal and written commands. The Attention and Calculation subscale results in a total possible score of 0 to 5, with higher scores indicating better function.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
709595|NCT00141518|Secondary|MMSE Registration Subscale Scores From Baseline to Month 36|The MMSE is used to assess orientation, attention, immediate and short term recall, language, and ability to follow simple verbal and written commands. The Registration subscale a total possible score of 0 to 3, with higher scores indicating better function.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
709596|NCT00141518|Secondary|MMSE Orientation Subscale Scores From Baseline to Month 36|The MMSE is used to assess orientation, attention, immediate and short term recall, language, and ability to follow simple verbal and written commands. The orientation subscale has a total possible score of 0 to 10, with higher scores indicating better function.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
709597|NCT00141518|Secondary|Mini Mental Status Examination (MMSE) Total Scores From Baseline to Month 36|The MMSE is used to assess orientation, attention, immediate and short term recall, language, and ability to follow simple verbal and written commands. The test consists of five sections (orientation, registration, attention-calculation, recall, and language) and results in a total possible score of 0 to 30, with higher scores indicating better function.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint visit (Month 36 or last visit if discontinued early)|Full Analysis Set: Participants who had ≥ 1 dose of study medication and (for Duodopa naives) had data for baseline and ≥ 1 post-baseline assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥ 1 more assessment of the primary efficacy measurements UPDRS and EQ-5D.||units on a scale||Standard Deviation|Mean
709598|NCT00141518|Secondary|"Schwab and England Scale: Best On Period Stage From Baseline to Month 36"|"The Schwab and England scale was used to rate the subject’s best “on” period during the past week by recording the percentage score, ranging between being completely independent (100%) and totally dependent (10%). On time is when PD symptoms are well controlled by the drug."|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||percentage score on a scale||Standard Deviation|Mean
709599|NCT00141518|Secondary|Modified Hoehn and Yahr Staging: Worst Stage From Baseline to Month 36|The worst PD stage that the participant experienced during the last month was characterized according to Modified Hoehn and Yahr criteria, measured on the following 8-point scale for staging: 0=no signs of disease; 1=unilateral disease; 1.5=unilateral plus axial involvement; 2=bilateral disease; 2.5=mild bilateral disease; 3=mild to moderate bilateral disease; 4=severe disability; and 5=wheelchair bound or bedridden unless aided.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
709600|NCT00141518|Secondary|Modified Hoehn and Yahr Staging: Best Stage From Baseline to Month 36|The best PD stage that the participant experienced during the last month was characterized according to Modified Hoehn and Yahr criteria, measured on the following 8-point scale for staging: 0=no signs of disease; 1=unilateral disease; 1.5=unilateral plus axial involvement; 2=bilateral disease; 2.5=mild bilateral disease; 3=mild to moderate bilateral disease; 4=severe disability; and 5=wheelchair bound or bedridden unless aided.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
711246|NCT00176488|Primary|Efficacy of the Sequential Use of a DNA Damaging Drug (Epirubicin) Followed by a Vinca Alkaloid (Vinorelbine) in the Treatment of Breast Cancer.||10 years|Study was closed prematurely and insufficient data was collected.|||||
709601|NCT00141518|Secondary|Modified Hoehn and Yahr Staging: Current Stage From Baseline to Month 36|The current stage of PD was characterized according to Modified Hoehn and Yahr criteria, measured on the following 8-point scale for staging: 0=no signs of disease; 1=unilateral disease; 1.5=unilateral plus axial involvement; 2=bilateral disease; 2.5=mild bilateral disease; 3=mild to moderate bilateral disease; 4=severe disability; and 5=wheelchair bound or bedridden unless aided.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
709602|NCT00141518|Primary|Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010|Indirect costs consist of sick-leave and early retirement due to PD, are applied to individuals only up to the age of 65 since the main indirect cost item - early retirement due to disability – is only available for individuals 30-64 years old. Sixty-five is also a common retirement age in Sweden. The average rate for US Dollar (USD) to SEK on 31 December 2010 was 1 USD = 6.734 SEK.|Baseline (month -3) for Duodopa-naïve participants, then at Month 0, and monthly thereafter until Month 36|All participants; n=fraction of number of participants younger than 65 years with indirect costs / number of participants assessed at given time point.||SEK 2010||Standard Deviation|Mean
709603|NCT00141518|Primary|Direct Monthly Non-medical Costs Per Participant, SEK 2010|Direct non-medical costs include nursing home, home help, personal assistance, informal care (from family member or friend) and transportation to inpatient, outpatient visits and nursing home. The average rate for US Dollar (USD) to SEK on 31 December 2010 was 1 USD = 6.734 SEK.|Baseline (month -3) for Duodopa-naïve participants, then at Month 0, and monthly thereafter until study completion (up to 48 months) for all participants|||SEK 2010|Participants|Standard Deviation|Mean
709604|NCT00141518|Primary|Monthly Direct Medical Cost (Excluding Drug Costs) Per Participant, SEK 2010|Direct medical costs consist of inpatient care, outpatient care (visits to physician, nurse, physiotherapist, occupational therapist, dietitian, speech therapist, counselor, and phone consultations). The average rate for US Dollar (USD) to SEK on 31 December 2010 was 1 USD = 6.734 SEK.|Baseline (month -3) for Duodopa-naïve participants, then at Month 0, and monthly thereafter until study completion (up to 48 months) for all participants|||SEK 2010|Participants|Standard Deviation|Mean
709605|NCT00141518|Primary|Monthly Drug Costs Per Participant, SEK 2010|Drug costs include Duodopa cost and cost of concomitant anti-PD medication. Drug costs are a direct medical cost. The average rate for US Dollar (USD) to SEK on 31 December 2010 was 1 USD = 6.734 SEK.|Baseline (month -3) for Duodopa-naïve participants, then at Month 0, and monthly thereafter until study completion (up to 48 months) for all participants|||SEK 2010|Participants|Standard Deviation|Mean
709606|NCT00141518|Primary|Total Monthly Cost Per Participant, in Swedish Crowns (SEK) 2010|"Total monthly costs include
Direct medical costs (inpatient care, outpatient care, and drug costs [including Duodopa cost and cost of concomitant anti-PD medication]).
Direct non-medical costs (nursing home, home help, personal assistance, informal care [from family member or friend] and transportation to inpatient, outpatient visits and nursing home).
Indirect costs (sick-leave and early retirement due to PD [applied to individuals only up to the age of 65 since the main indirect cost item, early retirement due to disability, is only available for individuals 30-64 years old. Sixty-five is also a common retirement age in Sweden]).
The average rate for US Dollar (USD) to SEK on 31 December 2010 was 1 USD = 6.734 SEK."|Baseline (month -3) for Duodopa-naïve participants, then at Month 0, and monthly thereafter until study completion (up to 48 months) for all participants|||SEK 2010|Participants|Standard Deviation|Mean
709607|NCT00141518|Primary|EQ-5D Visual Analog Scale (VAS) Score at Baseline and Month 12|The EQ-5D VAS records the participant's self-rated health on a scale from 0-100 where 100 is the 'best imaginable health state' and 0 is the 'worst imaginable health state.' The scale was normalized to a scale of 0 to 1, with higher values indicating a better health state.|Baseline (Month -3), Month 12|Full Analysis Set: Participants who had ≥ 1 dose of study medication and (for Duodopa naives) had data for baseline and ≥ 1 post-baseline assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥ 1 more assessment of the primary efficacy measurements UPDRS and EQ-5D.||units on a scale||Standard Deviation|Mean
709608|NCT00141518|Primary|Euro QoL 5 Dimensions Quality of Life Instrument (EQ-5D) Descriptive Systems Summary Index Score at Baseline and Month 12|The EQ-5D is a participant-answered questionnaire scoring 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that essentially attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 (worst health state) to 1.00 (perfect health state).|Baseline (Month -3), Month 12|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
709627|NCT00141778|Secondary|Acute Renal Failure|Percentage of patients with a creatinine concentrations >2.5mg/dl|Measured until the time of hospital discharge, from 5.7 to 6.8 days on average, depending on the study group.|The intention-to-treat analysis included anyone who had received any study medication.||percentage of patients|||Number
709628|NCT00141778|Primary|Postoperative Atrial Fibrillation|The primary endpoint of the study was the percentage of patients with electrocardiographically confirmed AF of at least 10 secs duration at any time following the end of surgery until hospital discharge, an average from 5.7 days in the ramipril group to 6.8 days in the placebo group. Patients were monitored continuously on telemetry throughout the postoperative period until discharge. Electrocardiograms were obtained for any rhythm changes detected on telemetry monitoring, and in addition, electrocardiograms were performed preoperatively, at admission to the intensive care unit, and daily starting on postoperative day 1. All electrocardiograms and rhythm strips were reviewed in a blinded fashion by a single cardiac electrophysiologist.|Measured from admission to the ICU until discharge from hospital|Four hundred fifty-eight patients were randomized. Of these 445 took study medication and were included in the intention-to-treat analysis.||percentage of patients|||Number
709609|NCT00141518|Primary|Unified Parkinson's Disease Rating Scale (UPDRS) Total Score, and UPDRS Subscores I, II, III, and IV at Baseline and Month 12|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. For Parts I-III and Total Score, each question is measured on a 5-point scale of 0 (normal or no disease effect) to 4 (maximum negative effect); for Part IV, questions are measured on a 5- or 2-point scale (0 or 1). Part I score is the sum of answers to 'Mentation, Behavior and Mood' questions, with a score range from 0-16. Part II score is the sum of answers to 'Activities of Daily Living' questions, with a score range from 0-52. Part III score is the sum of answers to 'Motor Examination' questions, with a score range from 0-108. Part IV score is the sum of answers to 'Complications of Therapy' questions, with a score range from 0-23. Total Score is the sum of the responses to the 31 questions (44 answers) that comprise Parts I-III of the scale, with a score range from 0-176. Higher scores are associated with more disability.|Baseline (Month -3), Month 12|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
709610|NCT00141726|Secondary|Percentage of Participants That Experience Grade 3 to 4 Adverse Events|To evaluate the toxicity of etanercept therapy in patients with sub-acute lung injury > 100 days post transplant, the percent incidence of grade 3 to 4 adverse events among evaluable patients was calculated.|continuously (and week 4, week 8 and week 12, week 20)|34 subjects were enrolled and evaluated for adverse events.||percentage of participants|||Number
709611|NCT00141726|Primary|Percent of Patients With a Greater Than or Equal to 10% Improvement in FEV1, or FVC, and DLCO|Response was defined as a greater than or equal to 10% improvement in the absolute value for FEV1 (for obstructive defects) or FVC (for restrictive defects), and DLCO (Diffusing Capacity of the Lungs for Carbon Monoxide) .|week 12 post therapy|34 subjects were enrolled. Thirty-one of 34 subjects were evaluable for response, with three subjects completing <50% of scheduled dosing.||percent evaluable participants|||Number
709612|NCT00141739|Secondary|The Impact of Tumor Necrosis Factor (TNF) Polymorphisms on Response to Therapy.||100 days|This was not analyzed in the population and there are no plans to analyze this in the future. The study is complete and the principal investigator has left the institution.|||||
709613|NCT00141739|Secondary|Day +7 TNFR1 Ratio in TBI-Treated Patients vs. Non-TBI-Treated Patients|The effect of etanercept on plasma cytokine levels after Hematopoietic Stem Cell Transplantation (HSCT) was analyzed. Tumor Necrosis Factor Receptor 1 (TNFR1) ratios (TNFR1 posttransplantation day+7 / TNFR1pretransplantation baseline were calculated. Patients who received Total Body Irradiation (TBI) transplant conditioning were compared to those who received another form of transplant conditioning.|Day+7, post transplant|TBI versus non-TBI transplant conditioning||TNFR1 Ratio||Full Range|Mean
709614|NCT00141739|Secondary|The Number of Patients That Experience Idiopathic Pulmonary Syndrome (IPS)|The Effect of etanercept on the incidence of idiopathic pulmonary syndrome (IPS). Patients who received Total Body Irradiation (TBI) transplant conditioning were compared to those who received another form of transplant conditioning.|100 days|TBI versus Non-TBI transplant conditioning||Participants|||Count of Participants
709615|NCT00141739|Secondary|Number of Patients Experiencing Etanercept Toxicity|Toxicity of etanercept was evaluated by the following: the number of patients experiencing allergic reactions, the number of patients that discontinued etanercept early, the number of patients experiencing bacteremia, and the number of patients experiencing viral reactivations.|100 days|||participants|||Number
709616|NCT00141739|Primary|The Percentage of Participants Experiencing Acute GVHD After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)|"In order to determine whether etanercept, given prophylactically along with a standard Graft Versus Host Disease (GVHD) prevention regimen, will decrease the 100-day mortality and the rate of acute GVHD after allogeneic hematopoietic stem cell transplantation(HSCT), the incidence of grades 2-4 and grades 3-4 GVHD were calculated.
GVHD can be clinically graded as 0, I, II, III, or IV. Definition of grades are:
Grade 0 - No stage 1-4 of any organ Grade I - Stage 1-2 rash and no liver or gut involvement Grade II - Stage 3 rash, or Stage 1 liver involvement, or Stage 1 gastrointestinal involvement Grade III - Stage 0-3 skin, with STage 2-3 liver, or Stage 2-3 gastrointestinal involvement Grade IV - Stage 4 skin, liver, or gastrointestinal involvement"|100 days|To provide Sufficient power||percentage of participants|||Number
709617|NCT00141765|Primary|Percent of Participants With Progression Free Survival at 1 Year|The primary outcome measure for this study was to improve the long-term disease-free survival of patients with rare cancers at high risk for lethal relapse.|1 year post transplant|||percentage of participants|||Number
709618|NCT00141778|Secondary|Perioperative C-reactive Protein (CRP) Concentrations|C-reactive protein was measured at several time points (see table) over the course of the study.|Perioperative period|CRP was measured in all subjects from the intention-to-treat analysis for which plasma was available at those time points.||ug/mL||Standard Deviation|Mean
709619|NCT00141778|Secondary|Perioperative Plasminogen Activator Inhibitor-1 (PAI-1) Concentrations|Plasminogen activator inhibitor-1 (PAI-1) was measured at several time points (see table) over the course of the study.|Perioperative period|PAI-1 was measured in all subjects in the intention-to-treat analysis for which plasma was available.||ng/mL||Standard Deviation|Mean
709620|NCT00141778|Secondary|Perioperative Interleukin(IL)-6 Concentrations|Interleukin-6 was measured at several time points (see time points in table) over the course of the study|Perioperative period|All participants included in the intention-to-treat analysis who had available plasma samples.||pg/ml||Standard Deviation|Mean
709621|NCT00141778|Secondary|Stroke|Percentage of patients in each study group who experience a cerebrovascular event, confirmed by CT.|Measured until the time of hospital discharge, from 5.7 to 6.8 days on average depending on the study arm.|The intention-to-treat analysis included all those who received any study drug.||percentage of patients|||Number
709622|NCT00141778|Secondary|Death|The percentage of patients in each study arm who died.|Measured until the time of hospital discharge|The intention-to-treat analysis included all patients who received any study medication.||percentage of patients|||Number
709623|NCT00141778|Secondary|Length of Hospital Stay (Days)||Measured from the day of surgery until the time of hospital discharge|The intention-to-treat analysis included anyone who had received any study medication.||days||Standard Deviation|Mean
711247|NCT00176501|Secondary|Rate of Graft-vs-host Disease||5 years|The study was closed early due to slow accrual and insufficient data were collected to analyse this outcome measure.|||||
709631|NCT00141817|Primary|Apparent Oral Clearance (CL/F)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose|Single-Dose Valid-for-Evaluation Population. Participants analyzed=number of participants with available data.||liter per hour per kilogram (L/h/kg)||Standard Deviation|Mean
709632|NCT00141817|Primary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose|Single-Dose Valid-for-Evaluation Population. Participants analyzed=number of participants with available data.||hours||Standard Deviation|Mean
709633|NCT00141817|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose|Single-Dose Valid-for-Evaluation Population. Participants analyzed=number of participants with available data.||ng*h/mL||Standard Deviation|Mean
709634|NCT00141817|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]|AUC (0-t)= Area under the plasma concentration versus time curve from time zero (predose) to time of last quantifiable concentration (0-t).|Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose|Single-Dose Valid-for-Evaluation Population.||nanogram hour per milliliter (ng*h/mL)||Standard Deviation|Mean
709635|NCT00141817|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose|Single-Dose Valid-for-Evaluation Population. Participants analyzed=number of participants with available data.||hours||Standard Deviation|Mean
709636|NCT00141817|Primary|Maximum Observed Plasma Concentration (Cmax)||Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose|Single-Dose Valid-for-Evaluation Population: Randomized participants who took 1 dose of pantoprazole and had at least 4 single-dose blood samples for pharmacokinetic (PK) analyses.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
709637|NCT00141921|Secondary|Improvement From Study 20030211 Baseline in Joint Pain|"Participants were asked to indicate how much joint pain they had experienced in the last 7 days on a visual analog scale (VAS) from no pain on the left end of the line (score = 0) to severe pain on the right side of the line (score = 10).
Improvement from baseline = (Baseline Value – Post-baseline Value)."|Study 20030211 baseline, Study 20050111 baseline and weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252 and 264|Participants who received at least one dose of investigational product and who completed the joint pain assessment at Study 20030211 baseline, and with available data at each time point.||units on a scale||Standard Deviation|Mean
709638|NCT00141921|Secondary|Percent Improvement From Study 20030211 Baseline in CDLQI Treatment Satisfaction Score|"The Children’s Dermatology Life Quality Index (CDLQI) was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (not at all) to 3 (Very much). The CDLQI Treatment Satisfaction Score includes 1 question (How much of a problem has the treatment for your skin been over the last week?) and ranges from 0 to 3, with lower scores indicating better quality of life.
Percent improvement from baseline = (Baseline Value – Post-baseline Value) / Baseline Value * 100."|Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264|Participants who received at least one dose of investigational product with baseline data and with available data at each time point.||percent improvement||Standard Deviation|Mean
709639|NCT00141921|Secondary|Percent Improvement From Study 20030211 Baseline in CDLQI Sleep Score|"The Children’s Dermatology Life Quality Index (CDLQI) was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (not at all) to 3 (Very much). The CDLQI Sleep Score includes 1 question (How much has your sleep been affected by your skin problems over the last week?) and ranges from 0 to 3, with lower scores indicating better quality of life.
Percent improvement from baseline = (Baseline Value – Post-baseline Value) / Baseline Value * 100."|Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264|Participants who received at least one dose of investigational product with baseline data and with available data at each time point.||percent improvement||Standard Deviation|Mean
709640|NCT00141921|Secondary|Percent Improvement From Study 20030211 Baseline in CDLQI Personal Relationships Score|"The Children’s Dermatology Life Quality Index (CDLQI) was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (not at all) to 3 (Very much). The CDLQI Personal Relationships Score includes 2 questions and ranges from 0 to 6, with lower scores indicating better quality of life.
Percent improvement from baseline = (Baseline Value – Post-baseline Value) / Baseline Value * 100."|Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264|Participants who received at least one dose of investigational product with baseline data and with available data at each time point.||percent improvement||Standard Deviation|Mean
709641|NCT00141921|Secondary|Percent Improvement From Study 20030211 Baseline in CDLQI School or Holidays Score|"The Children’s Dermatology Life Quality Index (CDLQI) was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (not at all) to 3 (Very much). The CDLQI School or Holidays Score includes 1 question (How much did your skin problem effect your school work/holiday plans over the last week?) and ranges from 0 to 3, with lower scores indicating better quality of life.
Percent improvement from baseline = (Baseline Value – Post-baseline Value) / Baseline Value * 100."|Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264|Participants who received at least one dose of investigational product with baseline data and with available data at each time point.||percent improvement||Standard Deviation|Mean
711248|NCT00176501|Secondary|Rate and Kinetics of Clinical/Radiological Response||5 years|The study was closed early due to slow accrual and insufficient data were collected to analyse this outcome measure.|||||
709642|NCT00141921|Secondary|Percent Improvement From Study 20030211 Baseline in CDLQI Leisure Score|"The Children’s Dermatology Life Quality Index (CDLQI) was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (not at all) to 3 (Very much). The CDLQI Leisure Score includes 3 questions and ranges from 0 to 9, with lower scores indicating better quality of life.
Percent improvement from baseline = (Baseline Value – Post-baseline Value) / Baseline Value * 100."|Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264|Participants who received at least one dose of investigational product with baseline data and with available data at each time point.||percent improvement||Standard Deviation|Mean
709643|NCT00141921|Secondary|Percent Improvement From Study 20030211 Baseline in CDLQI Symptoms and Feelings Score|"The Children’s Dermatology Life Quality Index (CDLQI) was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (not at all) to 3 (Very much). The CDLQI Symptoms and Feelings Score includes 2 questions and ranges from 0 to 6, with lower scores indicating better quality of life.
Percent improvement from baseline = (Baseline Value – Post-baseline Value) / Baseline Value * 100."|Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264|Participants who received at least one dose of investigational product with baseline data and with available data at each time point.||percent improvement||Standard Deviation|Mean
709644|NCT00141921|Secondary|Percent Improvement From Study 20030211 Baseline in Children’s Dermatology Life Quality Index (CDLQI) Total Score|"The Children’s Dermatology Life Quality Index (CDLQI) was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (Not at all) to 3 (Very much). The total score ranges from 0 to 30, with lower scores indicating better quality of life. If participants were ≥ 13 years old, the text instrument was completed by the participants themselves. Participants ≥ 8 but < 13 years old used the cartoon version of the instrument and participants ≤ 7 years old used the cartoon version of the instrument completed with help from the parents or caregivers.
Percent improvement from baseline = (Baseline Value – Post-baseline Value) / Baseline Value * 100."|Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264|Participants who received at least one dose of investigational product with baseline data, and with available data at each time point.||percent improvement||Standard Deviation|Mean
709645|NCT00141921|Secondary|Percentage of Participants With a Static Physician’s Global Assessment (sPGA) of Clear (0) or Almost Clear (1)|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).|Weeks 12, 48, 96, 144, 192, 240 and 264|Participants who received at least one dose of investigational product with available data at each time point.||percentage of participants|||Number
709646|NCT00141921|Secondary|Percent Improvement From Study 20030211 Baseline in PASI Score|"The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.
Percent improvement from baseline = (Baseline Value – Post-baseline Value) / Baseline Value * 100."|Study 20030211 baseline, Study 20050111 baseline and weeks 12, 48, 96, 144, 192, 240 and 264|Participants who received at least one dose of investigational product with available data at each time point.||percent improvement||Standard Deviation|Mean
709647|NCT00141921|Secondary|Percentage of Participants With a PASI 90 Response|"A PASI 90 response is a 90% or greater improvement (reduction) from baseline in PASI score.
The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis."|Baseline and weeks 12, 48, 96, 144, 192, 240 and 264|Participants who received at least one dose of investigational product with available data at each time point.||percentage of participants|||Number
709648|NCT00141921|Secondary|Percentage of Participants With a PASI 75 Response|"A PASI 75 response is a 75% or greater improvement (reduction) from baseline in PASI score.
The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis."|Baseline and weeks 12, 48, 96, 144, 192, 240 and 264|Participants who received at least one dose of investigational product with available data at each time point.||percentage of participants|||Number
709649|NCT00141921|Secondary|Percentage of Participants With a Psoriasis Area and Severity Index 50 Response (PASI 50)|"A PASI 50 response is a 50% or greater improvement (reduction) from baseline in PASI score.
The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis."|Baseline and weeks 12, 48, 96, 144, 192, 240 and 264|Participants who received at least one dose of investigational product and with available data at each time point.||percentage of participants|||Number
709650|NCT00141921|Secondary|Number of Participants Who Developed Anti-etanercept Antibodies|"Binding antibodies to etanercept were detected using an anti-etanercept immunoassay. The positive samples in the immunoassay were further analyzed for the presence of neutralizing antibodies using a bioassay.
Participants who developed anti-etanercept antibodies are those who were antibody positive post-baseline with a negative or no result at baseline."|264 weeks|Participants who received at least one dose of investigational product and had a post-baseline antibody result.||participants|||Number
711277|NCT00176852|Secondary|Overall Survival|Number of patients alive 1 year after transplant.|1 year|||Participants|||Count of Participants
711278|NCT00176852|Secondary|Overall Survival|Number of patients alive 100 days after transplant.|100 days|||Participants|||Count of Participants
709651|NCT00141921|Secondary|Number of Participants With Grade 3 and 4 Laboratory Toxicities|The severity assessment for adverse events and infections (not including injection site reaction) used the Common Toxicity Criteria (CTC) Version 2.0, where Grade 1= Mild - aware of sign or symptom, but easily tolerated; Grade 2= Moderate - discomfort enough to cause interference with usual activity; Grade 3 = Severe - incapacitating with inability to work or do usual activity; Grade 4= Life-threatening - refers to an event in which the patient was, in the view of the investigator, at risk of immediate death at the time of event; Grade 5 = Fatal.|264 weeks|Participants who received at least one dose of investigational product.||participants|||Number
709652|NCT00141921|Secondary|Number of Participants With Clinically Significant Changes in Vital Signs||264 weeks|Participants who received at least one dose of investigational product.||participants|||Number
709653|NCT00141921|Secondary|Exposure-adjusted Adverse Event Rates|"The exposure adjusted event rate for a given event in a given time period is defined as the number of events reported in the given time period divided by total patient-years on investigational product during the period.
Exposure-adjusted event rate per 100 patient years = total number of events / patient years * 100.
Multiple occurrences of the same event for a participant were counted as multiple events."|264 weeks|Participants who received at least one dose of investigational product.||events per 100 patient years|||Number
709654|NCT00141921|Secondary|Number of Participants With Injection Site Reactions|An injection site reaction is a reaction at the site of the subcutaneous injection, commonly characterized, but not limited to symptoms of erythema (redness, usually raised), pruritis (itching), swelling, or pain that is persistent for 4 hours or longer.|264 weeks|Participants who received at least one dose of investigational product.||participants|||Number
709655|NCT00141921|Primary|Number of Participants With Adverse Events|"A serious adverse events is any AE that
is fatal
is life threatening
requires in-patient hospitalization or prolongation of existing hospitalization
results in persistent or significant disability/incapacity
is a congenital anomaly/birth defect
other significant medical hazard. The severity assessment for adverse events and infections (except injection site reactions) was done using the Common Toxicity Criteria (CTC) Version 2.0, where Grade 3 indicates a severe toxicity (incapacitating with inability to work or do usual activity).
An infectious event is an event that was considered by the investigator to be an infectious episode. An injection site reaction is a reaction at the site of the subcutaneous injection, commonly characterized, but not limited to symptoms of erythema (redness, usually raised), pruritis (itching), swelling, or pain that is persistent for 4 hours or longer."|264 Weeks|Participants who received at least one dose of investigational product.||participants|||Number
709656|NCT00142116|Primary|Time to Progression|Time to disease progression (TTP) was calculated from the start of therapy using the Kaplan-Meier method.|49.1 months|||months||Full Range|Median
709657|NCT00142116|Secondary|To Identify the Mechanism(s) of Action for Combined Thalidomide and Rituximab Activity.||3 years||||||
709658|NCT00142116|Primary|Objective Response Rate|Response determinations were made using modified consensus panel criteria from the Third International Workshop on WM, and response rates were determined on an evaluable basis. A complete response was defined as having resolution of all symptoms, normalization of serum IgM levels with complete disappearance of IgM paraprotein by immunofixation, and resolution of any adenopathy or splenomegaly. Patients achieving a partial response and a minor response were defined as achieving a more than or equal to 50% and more than or equal to 25% reduction in serum IgM levels, respectively. Patients with stable disease were defined as having less than 25% change in serum IgM levels, in the absence of new or increasing adenopathy or splenomegaly and/or other progressive signs or symptoms of WM. Progressive disease was defined as a greater than 25% increase in serum IgM level occurred from the lowest attained response value or progression of clinically significant disease-related symptom(s).|3 years|Intent-to-treat basis||participants|||Number
709659|NCT00142168|Secondary|Minor Response Rate|A minor response is defined as having achieved >25% but less than 50% reduction in serum IgM levels.|34.3 months|Evaluable patients. 4 participants were withdrawn for adverse events and were unevaluable.||participants|||Number
709660|NCT00142168|Secondary|Major Response Rate|Major response rate is the number of participants who achieve at a PR or better. A PR or better will be defined as achieving a >50% reduction in serum IgM levels.|34.3 months|Evaluable patients. 4 participants were withdrawn for adverse events and were unevaluable.||participants|||Number
709661|NCT00142168|Primary|Overall Response|Overall response is the total number of participants who respond to therapy. Patients achieving a complete response (CR) will be defined as having achieved resolution of all symptoms, normalization of their serum IgM levels with complete disappearance of their IgM paraprotein by immunofixation, and resolution of any adenopathy or splenomegaly during any point while in this study and normal bone marrow biopsy. Patients achieving a partial response (PR) and a minor response (MR) will be defined as achieving a > 50% and > 25% reduction in serum IgM levels, respectively, during any point while in this study. Patients with stable disease (SD) will be defined as having < 25% change in serum IgM levels, in the absence of new or increasing adenopathy or splenomegaly and/or other progressive signs or symptoms of WMduring any point while in this study.|34.3 months|Evaluable patients. 4 participants were withdrawn for adverse events and were unevaluable.||participants|||Number
709662|NCT00142168|Primary|Time to Progression|Time to progression is measured as the length in time in months from starting therapy until progression, defined as 25% increase in serum IgM from nadir.|34.3 months|All enrolled patients||months||Full Range|Median
709663|NCT00142298|Primary|Percentage of Participants With Sustained Therapeutic Response [Group C: Other Feeder Studies]|"The primary efficacy endpoint for Group C (other feeder studies) was the percentage of patients with sustained therapeutic response (defined as HBV DNA < 5 log10 copies/mL and either HBeAg loss or ALT normalized) at Weeks 52 and 104 of off-treatment follow-up.
Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive study drug except in case of patients who relapsed and reinitiated treatment. No statistical summary was performed , only patient listing was generated."|52 weeks,104 weeks|"In Group C: other feeder study reporting group, there were only 13 patients; hence, no summary statistics were performed. Only listings were generated."|||||
709863|NCT00139659|Secondary|Glycosylated Hemoglobin (HbA1c)|Glycosylated Hemoglobin (HbA1c): observed mean values at Baseline and each observation, and change from Baseline. Change from Baseline = mean HbA1c at observation minus mean HbA1c at Baseline.|Baseline, Week 6, Week 12, Week 26, Week 39, Week 52, Week 52 Last Observation Carried Forward (LOCF)|Full analysis set (FAS)||percent||Standard Deviation|Mean
709664|NCT00142298|Primary|Percentage of Participants With Sustained Therapeutic Response [Group C: LdT Pool and LAM Pool (2302/015)]|The primary efficacy endpoint for Group C patients was the percentage of patients with sustained therapeutic response (defined as HBV DNA < 5 log10 copies/mL and either HBeAg loss or ALT normalized) at Weeks 52 and 104 of off-treatment follow-up. HBeAg loss is loss of detectable serum HBeAg in a patient who was HBeAg-positive at feeder baseline. ALT normalized is ALT within normal limits for a patient with an elevated ALT level (>1.0 × ULN) at either the feeder baseline or feeder screening visit. All efficacy data were analyzed separately for HBeAg-positive and HBeAg-negative patients.|52 weeks,104 weeks|The per protocol population. n= is the number of HBeAg-positive/HBeAg-negative patients from per protocol population who achieved maintained response at the end of treatment and had off-treatment assessment to determine the sustained response at that time point or lost sustained response before the off-treatment timepoint.||Percentage of Participants||95% Confidence Interval|Number
709665|NCT00142298|Primary|Percentage of Participants With Maintained Clinical Response [Group B: LAM 2301]|Maintained clinical response is defined as achievement of serum HBV DNA < 4 log10 copies/mL, normal serum ALT level and improvement or stabilization in Child-Turcotte-Pugh (CTP) score. Total CTP score ranges from 5 to 15; higher scores indicate liver impairment. Improvement is defined as a 2-point or greater reduction in CTP score, and stabilization is defined as a less than 2-point change in CTP score, compared to the patient’s baseline value. Analysis was done on the overall per protocol (PP) population and separately for the HBeAg-positive and HBeAg-negative subpopulation.|52 weeks,104 weeks|Per protocol (PP) population. The PP analysis was done on the overall PP population and separately for the HBeAg-positive and HBeAg-negative subpopulation (status at feeder baseline). n = the number of patients who were eligible for maintained clinical response.||Percentage of Participants||95% Confidence Interval|Number
709666|NCT00142298|Primary|Percentage of Participants With Maintained Clinical Response [Group B: LdT 2301]|Maintained clinical response is defined as achievement of serum HBV DNA < 4 log10 copies/mL, normal serum ALT level and improvement or stabilization in Child-Turcotte-Pugh (CTP) score. Total CTP score ranges from 5 to 15; higher scores indicate liver impairment. Improvement is defined as a 2-point or greater reduction in CTP score, and stabilization is defined as a less than 2-point change in CTP score, compared to the patient’s baseline value. Analysis was done on the overall per protocol (PP) population and separately for the HBeAg-positive and HBeAg-negative subpopulation.|156 weeks, 208 weeks (from feeder study baseline)|Per protocol (PP) population. The PP analysis was done on the overall PP population and separately for the HBeAg-positive and HBeAg-negative subpopulation (status at feeder baseline). n = the number of patients who were eligible for maintained clinical response.||Percentage of Participants||95% Confidence Interval|Number
709667|NCT00142298|Primary|Percentage of Participants Who Maintained Therapeutic Response [Group A: Feeder Studies 2401/2402/010]|The maintained therapeutic response is defined as hepatitis B virus (HBV) DNA < 5 log10 copies/mL and either hepatitis Be antigen (HBeAg) loss or alanine aminotransferase (ALT) normalized. HBeAg loss is loss of detectable serum HBeAg in a patient who was HBeAg-positive at feeder baseline. ALT normalized is defined as ALT within normal limits for a patient with an elevated ALT level (>1.0 × ULN) at either the feeder baseline or feeder screening visit. All efficacy data were analyzed separately for HBeAg-positive and HBeAg-negative patients.|52 weeks, 104 weeks|Per protocol (PP) population. The PP analysis was done on the PP population, separately for the HBeAg-positive and HBeAg-negative subpopulation (status as feeder baseline). n = the number of HBeAg-positive/HBeAg-negative patients who were eligible for maintained therapeutic response.||Percentage of Participants||95% Confidence Interval|Number
709668|NCT00142298|Primary|Percentage of Participants Who Maintained Therapeutic Response [Group A: LAM Pool 2302/015]|The maintained therapeutic response is defined as hepatitis B virus (HBV) DNA < 5 log10 copies/mL and either hepatitis Be antigen (HBeAg) loss or alanine aminotransferase (ALT) normalized. HBeAg loss is loss of detectable serum HBeAg in a patient who was HBeAg-positive at feeder baseline. ALT normalized is defined as ALT within normal limits for a patient with an elevated ALT level (>1.0 × ULN) at either the feeder baseline or feeder screening visit. All efficacy data were analyzed separately for HBeAg-positive and HBeAg-negative patients.|52 weeks, 104 weeks|Per protocol (PP) population. The PP analysis was done separately for the HBeAg-positive and HBeAg-negative subpopulation (status at feeder baseline). n = the number of HBeAg-positive/HBeAg-negative patients who were eligible for maintained therapeutic response.||Percentage of Participants||95% Confidence Interval|Number
709669|NCT00142298|Primary|Percentage of Participants Who Maintained Therapeutic Response [Group A: LdT Pool 2302/015]|The maintained therapeutic response is defined as hepatitis B virus (HBV) DNA < 5 log10 copies/mL and either hepatitis Be antigen (HBeAg) loss or alanine aminotransferase (ALT) normalized. HBeAg loss is loss of detectable serum HBeAg in a patient who was HBeAg-positive at feeder baseline. ALT normalized is defined as ALT within normal limits for a patient with an elevated ALT level (>1.0 × ULN) at either the feeder baseline or feeder screening visit. All efficacy data were analyzed separately for HBeAg-positive and HBeAg-negative patients.|156 weeks, 208 weeks (from feeder study baseline)|Per protocol (PP) population. The PP analysis was done on separately for the HBeAg-positive and HBeAg-negative subpopulation (status at feeder baseline). n = the number of HBeAg-positive/HBeAg-negative patients who were eligible for maintained therapeutic response.||Percentage of participants||95% Confidence Interval|Number
709670|NCT00142298|Secondary|To Determine the Longitudinal Frequency of Virologic Breakthrough and Characterize the Associated Mutations in the HBV Polymerase Gene in HBV DNA Amplified From Sera of Patients With Virologic Breakthrough||52 weeks, 104 weeks, 156 weeks, 208 weeks||||||
709671|NCT00142298|Secondary|To Longitudinally Assess the Durability of HBeAg Responses Achieved With Telbivudine Treatment and Other Previous Treatments in Patients||52 weeks, 104 weeks, 156 weeks, 208 weeks||||||
709672|NCT00142298|Secondary|To Longitudinally Assess the Clinical Efficacy of Longer-term Treatment With Telbivudine||52 weeks, 104 weeks, 156 weeks, 208 weeks||||||
709673|NCT00142298|Secondary|To Longitudinally Assess the Longer-term Antiviral Efficacy Achieved With Telbivudine Treatment||52 weeks, 104 weeks, 156 weeks, 208 weeks||||||
709728|NCT00150462|Primary|Area Under the Concentration-time Curve Extrapolated to Infinity (AUCinf) for Carfilzomib||Cycle 1, Day 1 at predose, 5, 15, and 30 minutes, and 1, 2, 4, and 24 hours post dose.|Participants with available pharmacokinetic (PK) data. AUCinf was only determined for cohorts receiving carfilzomib ≥ 11 mg/m². For cohorts with carfilzomib dose at 1.2–8.4 mg/m², carfilzomib was measurable at too few time points to allow a good estimation. Participants in the two Dose Expansion cohorts (20/27 mg/m²) were combined for PK analyses.||ng*minute/mL||Standard Deviation|Mean
709674|NCT00142415|Secondary|Number of Subjects With Best Overall Tumor Response|Tumor responses were evaluated using computed tomography and categorized according to RECIST v1.0 at baseline and at the end of every cycle (every 12 weeks) or after recovery from toxicity. Per RECIST v1.0 for target lesions and assessed by MRI: Complete Response (CR): Disappearance of all target lesions [no evidence of disease]; Partial Response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria.|Up to 9 months|The Evaluable Analysis Set comprises subjects who completed Cycle 1 (ie, received both 111-In-DOTA-cG250 and 177-Lu-DOTA-cG250) and had at least 1 post-baseline response assessment. The Evaluable Analysis Set includes 23 subjects who completed Cycle 1, 12 subjects who completed Cycle 2, and 4 subjects who completed Cycle 3.||participants|||Number
709675|NCT00142415|Primary|Radiation Absorbed Doses by Organ for 177-Lu-cG250|After each 177-Lu-cG250 administration, 3 whole-body scintigrams were acquired (directly after injection and 2-4 days and 5-7 days post-injection) and blood samples were drawn at 5, 30, 60, and 120 min, 2-4 days, and 5-7 days post-infusion. Estimated radiation absorbed doses were calculated according to the Medical Internal Radiation Dose scheme, which permits estimation of the factors required to calculate dose to one organ attributable to a source in another organ.|12 weeks|The Dosimetry Evaluable Analysis Set comprises all subjects who received at least 1 dose of 177-Lu-cG250.||mGy/MBq||Standard Deviation|Mean
709676|NCT00142415|Primary|Number of Subjects With Dose-limiting Toxicity (DLT) During Cycle 1|Subjects were monitored for AEs for ≥ 8 weeks after the last infusion of 177-Lu-DOTA-cG250 before dose escalation could be implemented. Toxicity was graded in accordance with the NCI CTCAE version 3.0. DLT was defined as the following treatment-related events: ≥ Grade 3 non-hematologic toxicity; ≥ Grade 4 hematologic toxicity (platelets < 25 × 10^9/L or leukocytes < 1.0 × 10^9/L) that persisted for > 4 weeks except anemia; thrombocytopenia < 10 × 10^9/L; clinically relevant myelotoxicity that required hospitalization and/or blood product transfusion (e.g., uncontrolled bleeding, infections that had to be treated clinically).|12 weeks|The Safety Analysis Set comprises all subjects who received at least 1 dose of 111-In-DOTA-cG250 or 177-Lu-DOTA-cG250.||participants|||Number
709677|NCT00142415|Primary|Number of Subjects With Treatment-emergent Adverse Events|Toxicity was graded in accordance with the NCI CTCAE version 3.0. Treatment-emergent adverse events (TEAEs) were reported based on clinical laboratory tests, physical examinations, and vital signs from pre-treatment through 4 weeks after the last dose of study treatment.|Up to 1 year|The Safety Analysis Set comprises all subjects who received at least 1 dose of 111-In-DOTA-cG250 or 177-Lu-DOTA-cG250.||participants|||Number
709678|NCT00142597|Primary|Change in Mu-opioid Receptor Occupancy|Here we report the change (post - pre) in mu-opioid receptor binding potential (BP) for the perigenual anterior cingulate. BP is a unitless measure and reflects the total maximum binding of receptors divided by the dissociation constant. BP = Bmax/Kd.|measured from baseline to week 5|||Unitless: binding potential is Bmax/Kd||Standard Deviation|Mean
709679|NCT00142818|Secondary|Naltrexone/Modafinil-treated Subjects Will Have Fewer Days of Cocaine Use, More Abstinent Days From Alcohol, and Fewer Heavy Drinking Days During the Follow up Period Compared to Placebo-treated Subjects.||4+13 weeks||||||
709680|NCT00142818|Secondary|Modafinil-treated Subjects Will Demonstrate a Significantly Greater Reduction in Cocaine Use Measured by the Number of BE-negative Urine Samples and Significantly Reduced Alcohol Use Measured by Fewer Days of Clinically Significant Drinking.||4+13 weeks||||||
709681|NCT00142818|Secondary|Naltrexone-treated Subjects Will Demonstrate a Significantly Greater Reduction in Cocaine Use Measured by the Number of BE-negative Urine Samples and Significantly Reduced Alcohol Use Measured by Fewer Days of Clinically Significant Drinking.||4+13 weeks||||||
709682|NCT00142818|Primary|Number of Days of Abstinence From Drinking and Number of Days of Clinically Significant Drinking (Measured by Timeline Follow Back at Week 14 and the 6-month Evaluation)||4+13 weeks||||||
709683|NCT00142818|Primary|Cocaine Use (Measured by Timeline Follow Back and Urine Screen at Week 14)||13 weeks|||number of cocaine negative urine samples||Standard Deviation|Mean
709684|NCT00142909|Secondary|Diastolic Blood Pressure||12 weeks|||mm Hg||Standard Deviation|Mean
709685|NCT00142909|Secondary|Diastolic Blood Pressure||1 Week|||mm Hg||Standard Deviation|Mean
709686|NCT00142909|Secondary|Systolic Blood Pressure||12 weeks|||mm Hg||Standard Deviation|Mean
709687|NCT00142909|Primary|SOWS: the Subjective Opiate Withdrawal Scale|The Subjective Opiate Withdrawal Scale (SOWS) consists of 16 symptoms rated in intensity by patients on a 5‐point scale of intensity as follows: 0=not at all, 1=a little, 2=moderately, 3=quite a bit, 4=extremely. The total score is a sum of item ratings, and ranges from 0 to 64. The greater the score, the greater the intensity of Opiate Withdrawal. Source: Reprinted from Handelsman et al. 1987, p. 296, by courtesy of Marcel Dekker, Inc.Other Sources: Gossop 1990; Bradley et al. 1987. ACCESSED: http://www.ncbi.nlm.nih.gov/books/NBK64244/|12 weeks|||units on a scale||Standard Deviation|Mean
709688|NCT00142909|Secondary|Systolic Blood Pressure||1 Week|||mm Hg||Standard Deviation|Mean
709689|NCT00142909|Primary|SOWS: the Subjective Opiate Withdrawal Scale|The Subjective Opiate Withdrawal Scale (SOWS) consists of 16 symptoms rated in intensity by patients on a 5‐point scale of intensity as follows: 0=not at all, 1=a little, 2=moderately, 3=quite a bit, 4=extremely. The total score is a sum of item ratings, and ranges from 0 to 64. The greater the score, the greater the intensity of Opiate Withdrawal. Source: Reprinted from Handelsman et al. 1987, p. 296, by courtesy of Marcel Dekker, Inc.Other Sources: Gossop 1990; Bradley et al. 1987. ACCESSED: http://www.ncbi.nlm.nih.gov/books/NBK64244/|1 Week|||units on a scale||Standard Deviation|Mean
709690|NCT00142935|Secondary|Non-fatal Overdose|Participants who self-reported experiencing an overdose within the past six months, based on responses to face-to-face administration of the 6 month interview.|6 month follow-up interviews|||participants|||Number
709691|NCT00142935|Secondary|Fatal Overdose|Number of participants who died as the result of drug poisoning within six months of release of incarceration. This outcome was based on review of death records.|Within six months from release of incarceration|||participants|||Number
709692|NCT00142935|Secondary|Drug Use|Participants who self-reported heroin use in the past 30 days, based on responses to face-to-face administration of the 6 month interview.|6 month follow-up interviews|||participants|||Number
709924|NCT00140244|Secondary|Hepatic Fat Content||At the end of each two month intervention|||percentage of liver volume||Standard Error|Mean
709694|NCT00142935|Primary|Time to MMT Initiation Post Release Based on Clinic Chart Review|Participants are considered to have successfully initiated community methadone maintenance treatment only if they make their first clinic appointment within 30 days after being released from incarceration. This outcome measures number of days from release to the first day of clinic attendance, only for those participants who successfully entered methadone treatment post release. Data source was methadone clinic chart review.|within 30 days post release from incarceration|Participants were analyzed as randomized (intent to treat). We calculated the mean number of days (and SD) between release from incarceration and first MMT clinic visit post release. Not all participants attended clinic within 30 days post release - those participants are not included in this analysis.||days||Standard Deviation|Mean
709695|NCT00142935|Primary|Treatment Engagement|Participants are considered to have successfully initiated community methadone maintenance treatment only if they make their first clinic appointment within 30 days after being released from incarceration. This outcome is measured by frequency - yes, participant attended initial clinic appointment within 30 days post release or no, participant did not attend clinic appointment within 30 days post release. Data source was methadone clinic chart review.|within 30 days post release of incarceration|We assessed community methadone treatment clinic attendance of all enrolled participants based on clinic chart review.||participants|||Number
709696|NCT00149994|Primary|Percentage of Participants With an Occurrence of Biopsy Proven Acute Rejection (BPAR) During the First 3 Months Post de Novo Liver Transplantation.|A BPAR is defined when the investigator had a suspicion of an acute rejection, where the final clinical diagnosis confirmed the occurrence of an acute rejection, where a biopsy was performed that confirmed the presence of an acute rejection, and where anti-rejection treatment intervention was initiated. The efficacy measured the first rejections (clinically and biopsy proven rejections) at 3 months.|Month 3|Intention to treat (ITT) population.||Percentage of Participants|||Number
709697|NCT00150176|Secondary|Time to Early Discontinuation for Any Reason|The number of days to early discontinuation is the number of days from randomization to early discontinuation from the study for adverse event, relapse or impending relapse that was not considered an adverse event, withdrawal of informed consent, or lost to follow-up (without evidence of relapse).|time of discontinuation up to Day 182 (double blind phase)|Intent to treat (ITT) population, additionally excluding subjects not treated and excluding subjects with past enrollment in an asenapine trial.||participants|||Number
709698|NCT00150176|Primary|Time to Relapse or an Impending Relapse|"A relapse or impending relapse was declared if a subject meets 1 of 3 symptomatic relapse criteria which were all based on a combination of the Positive and Negative Syndrome Scale (PANSS) total score or PANSS items, and Clinical Global Impression-Severity (CGI-S); or if in the opinion of the investigator, the subject's symptoms of schizophrenia had deteriorated to such an extent or the risk of violence to self or others or risk of suicide had increased so that certain prespecified measures were necessary."|time of first relapse up to Day 182 (double blind phase)|ITT population, excluding subjects not treated and w/ past enrollment in an asenapine trial. As trial progressed & subjects discont'd for various reasons, subjects at risk for relapse decreased from 190 each arm (Day 1) to 70 at risk in placebo arm and 135 subjects in asenapine arm (Day 182). Those relapsing >3 days after last dose also excluded.||relapses|||Number
709699|NCT00150345|Secondary|Number of Participants With Reasons Why Antineoplastic Therapy Not Continued as Planned||Day 28|MITT; data not summarized as planned; data insufficient for analysis due to missing data.||participants|||Number
709700|NCT00150345|Secondary|Number of Participants Assessed as Needing Further Antineoplastic Therapy as Planned||Day 28|MITT||participants|||Number
709701|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Mortality by Day 28 (Died)|Percent of positive panfungal PCR assessments during treatment phase of study in association with mortality on or before Day 28 after start of study treatment (Died). A participant must have died before Day 28 (final visit).|Day 2 through Day 28|"MITT; participants who completed the study and had a non-missing value for percent of positive panfungal PCR: no participants met this criteria within the category Died."||percent of positive PCR assessments|||Number
709702|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Mortality by Day 28 (Alive)|Percent of positive panfungal PCR assessments during treatment phase of study in association with mortality on or before Day 28 after start of study treatment (Alive). A participant must be evaluable until Day 28 (final visit).|Day 2 through Day 28|"MITT; participants who completed the study and had a non-missing value for percent of positive panfungal PCR. N=number of participants for category Alive."||percent of positive PCR assessments||Standard Deviation|Mean
709703|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Reasons for Lack of Continuous Defervescence: Unknown Infection (Yes)|Percent of positive panfungal PCR assessments during treatment phase of study in association with lack of continuous defervescence (Yes). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.|Day 2 through Day 28|MITT; N=number of participants who completed the study and had a non-missing value for percent of positive panfungal PCR for immediate voriconazole and deferred voriconazole treatment, respectively.||percent of positive PCR assessments||Standard Deviation|Mean
709704|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Reasons for Lack of Continuous Defervescence (No)|Percent of positive panfungal PCR assessments during treatment phase of study in association with lack of continuous defervescence (No). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.|Day 2 through Day 28|MITT; (n)=number of participants who completed the study and had a non-missing value for percent of positive panfungal PCR for immediate voriconazole and deferred voriconazole treatment, respectively.||percent of positive PCR assessments||Standard Deviation|Mean
709705|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Time to Defervescence|Percent of positive panfungal PCR assessments during treatment phase of study in association with time to defervescence. Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.|Day 2 through Day 28|MITT. Correlation of positive panfungal PCR assessments with time to defervescence was not summarized as planned.||percent of positive PCR assessments||Standard Deviation|Mean
709925|NCT00140244|Secondary|Interleukin-6 (IL-6) Levels||At the end of each two month intervention|||pg/ml||Standard Error|Mean
709706|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Defervescence (No) by Day 9 (8 Days After Initiation of Study Treatment)|Percent of positive panfungal PCR assessments during treatment phase of study in association with defervescence (were afebrile) Day 9 (No). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.|Day 2 through Day 9 (192 hours through 216 hours after start of study treatment)|MITT; N=number of participants who completed the study and had a non-missing value for percent of positive panfungal PCR.||percent of positive PCR assessments||Standard Deviation|Mean
709707|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Defervescence (Yes) by Day 9 (8 Days After Initiation of Study Treatment)|Percent of positive panfungal PCR assessments during treatment phase of study in association with defervescence (were afebrile) Day 9 (Yes). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.|Day 2 through Day 9 (192 hours through 216 hours after start of study treatment)|MITT; N=number of participants who completed the study and had a non-missing value for percent of positive panfungal PCR.||percent of positive PCR assessments||Standard Deviation|Mean
709708|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Defervescence Day 5 (4 Days After Initiation of Study Treatment)|Percent of positive panfungal PCR assessments during treatment phase of study in association with defervescence (were afebrile) Day 5 (Yes or No). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.|Day 5 (96 hours through 120 hours after start of study treatment)|MITT; (n)=number of participants who completed the study and had a non-missing value for percent of positive panfungal PCR for immediate voriconazole and deferred voriconazole treatment, respectively.||percent of positive PCR assessments||Standard Deviation|Mean
709709|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Proven or Probable IFI (Complete Cases) Between Day 2 and Day 28|Percent of positive panfungal PCR assessments during treatment phase of study in association with proven or probable IFI (complete cases) between Day 2 and Day 28 (Yes or No). Complete case analysis: participant must be evaluable until Day 28 (final visit) or have developed a proven or probable IFI by the final visit. Participant considered evaluable until Day 28 if participant completed the study and completed an assessment of IFI at Day 28 or final visit. Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.|Day 2 through Day 28|MITT; (n)=number of participants who completed the study and had a non-missing value for percent of positive panfungal PCR for immediate voriconazole and deferred voriconazole treatment, respectively.||percent of positive PCR assessments||Standard Deviation|Mean
709710|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Fungal Species Identified (Aspergillus Spp=Yes)|Percent of positive panfungal PCR assessments during treatment phase of study in association with fungal species (singular [one species]=sp; plural [many species]=spp) identified (Yes). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.|Day 2 through Day 28|MITT; N=number of participants who completed the study and had a non-missing value for percent of positive panfungal PCR.||percent of positive PCR assessments||Standard Deviation|Mean
709711|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Fungal Species Identified|Percent of positive panfungal PCR assessments during treatment phase of study in association with fungal species (singular [one species]=sp; plural [many species]=spp) identified (Yes or No). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.|Day 2 through Day 28|MITT; (n)=number of participants who completed the study and had a non-missing value for percent of positive panfungal PCR for immediate voriconazole and deferred voriconazole treatment, respectively.||percent of positive PCR assessments||Standard Deviation|Mean
709712|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With C-reactive Protein Level >1.25 Times the Upper Limit of Normal (x ULN)|Percent of positive panfungal PCR assessments during treatment phase of study in association with c-reactive protein level (measured in milligrams per liter [mg/L]) >1.25 x ULN (Yes or No). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.|Day 2 through Day 28|MITT. Correlation of positive panfungal PCR assessments with c-reactive protein level was not summarized as planned.||percent of positive PCR assessments||Standard Deviation|Mean
709713|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Neutrophil Count >500 uL|Percent of positive panfungal PCR assessments during treatment phase of study in association with neutrophil count >500 uL (Yes or No). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.|Day 2 through Day 28|MITT; (n)=number of participants who completed the study and had a non-missing value for percent of positive panfungal PCR for immediate voriconazole and deferred voriconazole treatment, respectively.||percent of positive PCR assessments||Standard Deviation|Mean
709714|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Concomitant Fluconazole|Percent positive panfungal PCR assessments during treatment phase of study in association with use of concomitant (prophylaxis) fluconazole (Yes or No). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.|Day 2 through Day 28|MITT; (n)=number of participants who completed the study and had a non-missing value for percent of positive panfungal PCR for immediate voriconazole and deferred voriconazole treatment, respectively.||percent of positive PCR assessments||Standard Deviation|Mean
709715|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Planned Allogeneic Transplants|Percent of positive panfungal PCR assessments during treatment phase of study in association with allogeneic bone marrow transplant or allogeneic peripheral stem cell transplant (Yes or No). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.|Day 2 through Day 28|MITT; (n)=number of participants who completed the study and had a non-missing value for percent of positive panfungal PCR for immediate voriconazole and deferred voriconazole treatment, respectively.||percent of positive PCR assessments||Standard Deviation|Mean
709716|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Primary Underlying Neoplastic Disease|Percent of positive panfungal PCR assessments during treatment phase of study in association with primary underlying neoplastic disease. Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.|Day 2 through Day 28|MITT; (n)=number of participants who completed the study and had a non-missing value for percent of positive panfungal PCR for immediate voriconazole and deferred voriconazole treatment, respectively.||percent of positive PCR assessments||Standard Deviation|Mean
709717|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Gender|Percent of positive panfungal PCR assessments during treatment phase of study in association with gender (Female or Male). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.|Day 2 through Day 28|MITT; (n)=number of participants who completed the study and had a non-missing value for percent of positive panfungal PCR for immediate voriconazole and deferred voriconazole treatment, respectively.||percent of positive PCR assessments||Standard Deviation|Mean
709718|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Age|Percent of positive panfungal PCR assessments during treatment phase of study in association with age for participants who completed the study and have a non-missing value for percent of positive panfungal PCR.|Day 2 through Day 28|MITT. Correlation of positive panfungal PCR assessments with age was not summarized as planned.||percent of positive PCR assessments||Standard Deviation|Mean
709719|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association of Positive PCR Assessments With Achievement of Continuous Defervescence (No)|Percent of positive panfungal PCR assessments during treatment phase of study in association with achievement of continuous defervescence (response=No). Continuous defervescence stated if participant maintains a body temperature of <38.0 degrees C for at least 96 hours. Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.|Day 2 through Day 28|MITT; N=number of participants who completed the study and had a non-missing value for percent of positive panfungal PCR.||percent of positive PCR assessments||Standard Deviation|Mean
709720|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association of Positive PCR Assessments With Achievement of Continuous Defervescence (Yes)|Percent of positive panfungal PCR assessments during treatment phase of study in association with achievement of continuous defervescence (response=Yes). Continuous defervescence stated if participant maintains a body temperature of <38.0 degrees C for at least 96 hours. Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.|Day 2 through Day 28|MITT; N=number of participants who completed the study and had a non-missing value for percent of positive panfungal PCR.||percent of positive PCR assessments||Standard Deviation|Mean
709721|NCT00150345|Secondary|Time to Negative Panfungal Polymerase Chain Reaction (PCR)|Time (in days) from start of study medication to negative panfungal PCR; assessed for participants whose most recent panfungal PCR result prior to start of study medication was positive. Defined as negative if at least 2 successive and all following panfungal PCR assessments from start of study medication until 24 hours after end of treatment are negative. Measured as first quartile of time (point in time measurement; no median or measure of dispersion calculated); median time was not estimable for deferred voriconazole treatment group.|Day 2 through Day 28|MITT; N=number of participants whose most recent panfungal PCR result prior to start of study medication was positive.||days|||Number
709722|NCT00150345|Secondary|Number of Participants That Died on or Before Day 28 (Mortality)|Number of participants that died on or before Day 28 after start of study treatment. A participant must be evaluable until Day 28 (final visit) or have died before the final visit.|Day 2 through Day 28|MITT; N=number of participants evaluable until Day 28 (final visit) or died before the final visit.||participants|||Number
709723|NCT00150345|Secondary|Number of Participants Per Reason for Lack of Defervescence||Day 2 through Day 28|MITT||participants|||Number
709724|NCT00150345|Secondary|Time to Continuous Defervescence|Time (in days) from start of study medication to continuous defervescence. Continuous defervescence stated if participant maintains a body temperature of <38.0 degrees C for at least 96 hours.|Day 2 through Day 28|MITT||days||95% Confidence Interval|Median
709725|NCT00150345|Secondary|Number of Participants With Defervescence Day 9 (8 Days After Initiation of Study Treatment)|Number of participants who achieved defervescence (were afebrile). Defervescence stated if all of a participant's body temperatures within 24 hours of evaluation time were <38.0 degrees C. Defervescence was not stated and participant was discontinued from the study if participant received antipyretics (non-steroidal anti-inflammatory drugs or paracetamol).|Day 9 (192 hours through 216 hours after start of study treatment)|MITT||particpants|||Number
709726|NCT00150345|Secondary|Number of Participants With Defervescence Day 5 (4 Days After Initiation of Study Treatment)|Number of participants who achieved defervescence (were afebrile). Defervescence stated if all of a participants's body temperatures within 24 hours of evaluation time were <38.0 degrees C. Defervescence was not stated and participant was discontinued from the study if participant received antipyretics (non-steroidal anti-inflammatory drugs or paracetamol).|Day 5 (96 hours through 120 hours after start of study treatment)|MITT||participants|||Number
709727|NCT00150345|Primary|Number of Participants With Proven or Probable Invasive Fungal Infections (IFI): Complete Case Analysis|Number of participants with proven (deep tissue infection, fungemia, or endemic fungal infections) or probable IFI (at least 1 host criterion [fever, body temperature <36 or >38 degrees Celsius, graft-versus-host disease, use of corticosteroids]; and 1 microbiological criterion [fungal or yeasts]; or clinical criteria [abnormal site consistent with infection]) as defined by European Organization for Research and Treatment of Cancer Mycosis Study Group (EORTC/MSG) criteria. Complete case analysis: must be evaluable until Day 28 or had developed a proven or probable IFI by the final visit.|Day 2 through Day 28|Modified Intent-to-Treat population (MITT): participants in ITT population (at least 1 dose of study treatment) with valid post-baseline proven or probable IFI, did not have fungemia or other IFI at screening or randomization, no antipyretic analgesics on Day 5 (or Day 9 of open-label voriconazole). N=number of complete case evaluable participants.||participants|||Number
709757|NCT00150969|Secondary|Percent Change in Bone Mineral Density (BMD) at the Total Hip Between Treatment Arms.|BMD was measured yearly on one scanner at UHN using DEXA Hologic 4500A densitometer|0 to 48 months|||percentage change in BMD||Standard Deviation|Mean
709729|NCT00150462|Primary|Area Under the Concentration-time Curve to Last Measureable Timepoint (AUClast) for Carfilzomib||Cycle 1, Day 1 at predose, 5, 15, and 30 minutes, and 1, 2, 4, and 24 hours post dose.|Participants with available pharmacokinetic (PK) data. AUClast was only determined for cohorts receiving carfilzomib ≥ 11 mg/m². For cohorts with carfilzomib dose at 1.2–8.4 mg/m², carfilzomib was measurable at too few time points to allow a good estimation. Participants in the two Dose Expansion cohorts (20/27 mg/m²) were combined for PK analyses.||ng*minute/mL||Standard Deviation|Mean
709730|NCT00150462|Primary|Time to Maximum Observed Plasma Concentration of Carfilzomib (Tmax)||Cycle 1, Day 1 at predose, 5, 15, and 30 minutes, and 1, 2, 4, and 24 hours post dose.|Participants with available pharmacokinetic (PK) data. Tmax was only determined for cohorts receiving carfilzomib ≥ 11 mg/m². For cohorts with carfilzomib dose at 1.2-8.4 mg/m², carfilzomib was measurable at too few time points to allow a good estimation. Participants in the two Dose Expansion cohorts (20/27 mg/m²) were combined for PK analyses.||minutes||Standard Deviation|Mean
709731|NCT00150462|Secondary|Progression-free Survival|Progression-free survival is defined as the time from the date of Cycle 1, Day 1 of treatment to the date of documented assessment of progressive disease or death, whichever comes first, plus one day. Participants without tumor progression or death were censored at the date of their last valid clinical response assessment. Median progression-free survival was calculated using the Kaplan-Meier method.|From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 6.3 weeks in the dose escalation phase and 6.4 weeks in the dose expansion phase.|Biologic response-evaluable population||days||Full Range|Median
709732|NCT00150462|Secondary|Time to Progression|"Time to progressive disease is defined as the time from the date of Cycle 1, Day 1 of treatment to the date of documented assessment of progressive disease, plus one day. Participants without tumor progression were censored at the date of their last clinical response assessment.
Median time to progression was calculated using the Kaplan-Meier method."|From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 6.3 weeks in the dose escalation phase and 6.4 weeks in the dose expansion phase.|Biologic response-evaluable population||days||Full Range|Median
709733|NCT00150462|Secondary|Duration of Response|"Duration of objective response is defined as the time from the date of first documented assessment of clinical response (confirmed or unconfirmed complete response, partial response, or minimal response) to the date of documented assessment of progressive disease or death, whichever comes first, plus one day. Participants without tumor progression or death were censored at the date of their last valid clinical response assessment.
Median duration of response was calculated using the Kaplan-Meier method."|From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 6.3 weeks in the dose escalation phase and 6.4 weeks in the dose expansion phase.|Biologic response-evaluable participants with an objective response||days||Full Range|Median
709734|NCT00150462|Secondary|Best Clinical Response to Treatment|"Disease response criteria for NHL were according to the International Working Group Criteria for Non-Hodgkin’s Lymphoma. Disease response criteria for Multiple Myeloma were according to the European Group for Blood and Marrow Transplantation (EBMT). Disease response criteria for WM were according to the consensus panel recommendations from the Second International Workshop on Waldenström’s Macroglobulinemia. The disease response criteria for Hodgkin’s Lymphoma are defined as follows:
Complete response: total resolution of measurable disease parameters.
Partial response: a ≥ 50% resolution without the appearance of new disease.
Stable disease: between < 50% resolution and ≤ 25% increases in measurable disease parameters without appearance of new disease.
Progressive disease: an increase of > 25% in measurable disease parameters.
Best clinical response is the best response observed from the start of study treatment until disease progression or death."|From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 6.3 weeks in the dose escalation phase and 6.4 weeks in the dose expansion phase.|Biologic response-evaluable: All participants who received at least 1 cycle of carfilzomib and had both baseline and at least 1 post-baseline disease assessment.||participants|||Number
709735|NCT00150462|Primary|Maximum Observed Plasma Concentration of Carfilzomib (Cmax)||Cycle 1, Day 1 at predose, 5, 15, and 30 minutes, and 1, 2, 4, and 24 hours post dose.|Participants with available pharmacokinetic (PK) data. Cmax was only determined for cohorts receiving carfilzomib ≥ 11 mg/m². For cohorts with carfilzomib dose at 1.2-8.4 mg/m², carfilzomib was measurable at too few time points to allow a good estimation. Participants in the two Dose Expansion cohorts (20/27 mg/m²) were combined for PK analyses.||ng/mL||Standard Deviation|Mean
709736|NCT00150462|Primary|Number of Participants With Dose-limiting Toxicities (DLTs)|"A DLT was defined as any of the following occurring in the first 28 days of study participation:
Nonhematologic:
> Grade 2 neuropathy with pain
≥ Grade 3 nonhematologic toxicity (excluding nausea, vomiting, or diarrhea)
≥ Grade 3 nausea, vomiting, or diarrhea uncontrolled by maximal antiemetic/antidiarrheal therapy
Hematologic:
Grade 4 neutropenia (absolute neutrophil count [ANC] < 0.5 × 10ˆ9/L) lasting ≥ 14 days without hematopoietic growth factor support
Febrile neutropenia (ANC < 1.0 × 10ˆ9/L with a fever ≥ 38.3°C)
Grade 4 thrombocytopenia (platelets < 25.0 × 10ˆ9/L) or thrombocytopenia associated with bleeding.
Toxicities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) of the National Cancer Institute (NCI) version 3.0."|28 days|Safety-evaluable: All participants who were enrolled and received at least 1 dose of carfilzomib||participants|||Number
709737|NCT00150592|Secondary|Change From Baseline in Pictorial Sleepiness Scale (PSS) Scores at 6 Weeks|The Pictorial Sleepiness Scale (PSS) scores range from 1 (far left wide awake face) to 5 (far right very sleepy face). Increasing score reflects greater sleepiness.|Baseline and 6 weeks|FAS||Units on a Scale||Standard Deviation|Mean
709738|NCT00150592|Secondary|Change From Baseline in Pediatric Daytime Sleepiness Scale (PDSS) Scores at 6 Weeks|The Pediatric Daytime Sleepiness Scale (PDSS) is an 8 question questionnaire scored on a scale from 0 (never) to 4 (always). Total scores range from 0 to 32, with increasing score reflecting greater sleepiness.|Baseline and 6 weeks|FAS||Units on a Scale||Standard Deviation|Mean
709739|NCT00150592|Secondary|Number of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I) at 6 Weeks|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|6 weeks|FAS||Participants|||Number
709758|NCT00150969|Secondary|Effect of Vitamin K1 Supplementation on Percent of Carboxylation of Osteocalcin|measured by osteocalcin hydroxyapatite binding assay|0 to 24 months|||percentage of undercarboxylated OC||Standard Deviation|Mean
709740|NCT00150592|Secondary|Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Total Score at 6 Weeks|Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|Baseline and 6 weeks|Full Analysis Set (FAS) defined as all subjects who received at least one dose of investigational product.||Units on a Scale||Standard Deviation|Mean
709741|NCT00150592|Secondary|Change From Baseline in Spatial Working Memory (SWM) Scores at 6 Weeks|"The Spatial Working Memory (SWM) Test is a computerized assessment of working memory and strategy performance. The subject is required to find blue tokens in various displayed boxes and use the tokens to fill a column on the right side of the screen. Subjects can only find tokens in new boxes, therefore they must remember where previous tokens were found. SWM scores including number of between errors, number of within errors, and number of double errors range 0-800 and SWM strategy scores range 8-56. Lower scores indicate better performance."|Baseline and 6 weeks|PP||Units on a scale||Standard Deviation|Mean
709742|NCT00150592|Secondary|Change From Baseline in DSST/Coding Scores at 6 Weeks in Age Category 6-7 Years|The Digital Symbol Substitution Task/Coding Test (DSST/Coding) assesses relative contributions of speed, memory, and visual scanning. Subjects are required to copy symbols that are paired with simple geometric shapes or numbers within a specific time. Scores range from 0-65 in age category 6-7 years and 0-199 in age category 8-17 years. Higher scores indicate better performance.|Baseline and 6 weeks|PP||Units on a scale||Standard Deviation|Mean
709743|NCT00150592|Secondary|Change From Baseline in Digital Symbol Substitution Task/Coding Test (DSST/Coding) Scores at 6 Weeks in Age Category 8-17 Years|The Digital Symbol Substitution Task/Coding Test (DSST/Coding) assesses relative contributions of speed, memory, and visual scanning. Subjects are required to copy symbols that are paired with simple geometric shapes or numbers within a specific time. Scores range from 0-65 in age category 6-7 years and 0-199 in age category 8-17 years. Higher scores indicate better performance.|Baseline and 6 weeks|PP||Units on a scale||Standard Deviation|Mean
709744|NCT00150592|Primary|Change From Baseline in Choice Reaction Time (CRT) at 6 Weeks|Choice reaction time (CRT) is a computerized assessment that trains the subject in holding down a press-pad and releasing the press-pad in response to stimuli presented on the screen. The task requires the subject to react as soon as a yellow dot appears in one of five locations, and the subject must respond by lifting their hand from the press-pad. This is the reaction time (RT) and ranges from 100 to 5000 msec. Lower scores indicate better performance.|Baseline and 6 weeks|Per protocol (PP) defined as all subjects who completed the study and were deemed to be protocol-compliant.||msec||Standard Deviation|Mean
709745|NCT00150618|Secondary|Change From Baseline in Child Health Questionnaire-Parent Form (CHQ-PF50) Score at 6 Weeks|The Child Health Questionnaire-Parent Form (CHQ-PF50) was developed to measure the physical and psychosocial well-being of children aged 5 years of age and older. Total scoring ranges from 0-100. Increases in scores represent improved well-being in subjects as assessed by their parents.|Baseline and 6 weeks|ITT||units on a scale||Standard Error|Least Squares Mean
709746|NCT00150618|Secondary|Number of Participants With Improvement in Parent Global Assessment (PGA)|Parent Global Assessment (PGA) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|6 weeks|ITT||Participants|||Number
709747|NCT00150618|Secondary|Number of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I)|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|6 weeks|ITT||Participants|||Number
709748|NCT00150618|Secondary|Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) Score at 6 Weeks|The Conner's Parent rating Scale-revised short version (CPRS-R) consists of 27 questions graded on a scale from 0 (not true at all) to 3 (very much true) with a total score ranging from 0 to 81. Higher scores are indicative of increased ADHD. This scale allows parents to respond on the basis of the child's behavior and help assess ADHD and evaluate problem behavior.|Baseline and 6 weeks|ITT||Units on a Scale||Standard Error|Least Squares Mean
709749|NCT00150618|Primary|Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Score at 6 Weeks|Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|Baseline and 6 weeks|Intent to treat (ITT) defined as all subjects who were randomized to treatment and had the Baseline and at least one post-randomization primary efficacy measurement.||Units on a Scale||Standard Error|Least Squares Mean
709750|NCT00150969|Secondary|Difference in Number of New Clinical Fractures by Treatment Arm.|these included fragility fractures|up to 48 months|||events|||Number
709751|NCT00150969|Secondary|Difference in Number of New Cancers by Treatment Arm.||up to 48 months|||events|||Number
709752|NCT00150969|Secondary|Difference in Serious Adverse Events|These include hospitalizations for pneumonia, heart failure, gastro-intestinal bleeding, elective and non-elective surgery, cancer and death.|up to 48 months|||events|||Number
709753|NCT00150969|Secondary|Percent Change in Bone Mineral Density (BMD) at the Ultra-distal Radius Between Treatment Arms.|BMD was measured yearly on one scanner at UHN using DEXA Hologic 4500A densitometer|0 to 48 months|||percentage change in BMD||Standard Deviation|Mean
709754|NCT00150969|Secondary|Percent Change in Bone Mineral Density (BMD) at the Femoral Neck Between Treatment Arms.|BMD was measured yearly on one scanner at UHN using DEXA Hologic 4500A densitometer|0 to 48 months|||percentage change in BMD||Standard Deviation|Mean
709755|NCT00150969|Secondary|Percent Change in Bone Mineral Density (BMD) at the Lumbar Spine (L1-L4) Between Treatment Arms.|BMD was measured yearly on one scanner at UHN using DEXA Hologic 4500A densitometer|0 to 48 months|||percentage change in BMD||Standard Deviation|Mean
709756|NCT00150969|Primary|Percent Change in Bone Mineral Density (BMD) at the Total Hip Between Treatment Arms.|BMD was measured yearly on one scanner at UHN using DEXA Hologic 4500A densitometer|0 to 24 months|For our 2 year BMD anlayses we included all 440 women based on intention to treat using last observation carried forward for missing data.||percentage change in BMD||Standard Deviation|Mean
709926|NCT00140244|Secondary|CD4+ Lymphocytes||At the end of each two month intervention|||cells/mcl||Standard Error|Mean
709764|NCT00151281|Secondary|The Quality of Life (QoL) of Patients Receiving RT-PEPC Treatment|"QoL assessments were obtained with version 3 of the Functional Assessment of Cancer Therapy-General (FACT-G) instrument. The FACT-G is comprised of four subscales: physical well-being (7-items, score range 0-28), social/family well-being (7-items, score range 0-28), emotional well-being (6-items, score range 0-24), and functional well-being (7-items, score range 0-28). Users of the FACT-G are able to generate an overall score and four subscale scores with ranges and distributions that are sample-specific. All questions in the FACT-G use a 5-point rating scale (0 = Not at all to 4 = Very much) A higher number indicates a better Quality of Life, and has a possible range of 0-108 points.
ANOVA was used to compare the difference in the means of total score among the different time points (baseline, every 2M until 6M, and every 6M until PD). The mean of the total FACT-G scores at baseline and mean of total score at all timepoints (using ANOVA) are reported below."|baseline, every 2 months until Month 6, and every 6 months until disease progression|||FACT-G score||Full Range|Mean
709765|NCT00151281|Secondary|Dynamic Levels of Plasma VEGF|Stromal angiogenesis was assessed using blood vascular and perivascular markers, including VEGFR-1, VEGFR-2, CD34, and a-SMA, as well as lymphatic vascular markers ofVEGFR-3, podoplanin, and Lyve-1.|38 months|subjects with evaluable VEGF level at baseline||pg/mL||Full Range|Median
709766|NCT00151281|Secondary|Asses the Toxicity Profiles|Toxicities were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0.|38 months|patients treated with study drug||Participants|||Count of Participants
709767|NCT00151281|Primary|Overall Survival and Progression Free Survival|measured by overall Response Rate (ORR), which includes Complete response and partial response.|38 months|Twenty-five patients were enrolled, and 22 of those patients were assessable for response (3 patients were enrolled but received no therapy)||percentage of patients|||Number
709768|NCT00151320|Primary|ORR|Overall Response Rate|6 cycles (18 weeks)|||percentage of patients|||Number
709769|NCT00151372|Secondary|Hamilton Depression Rating Scale|The 17-item Hamilton Depression Rating Scale (HDRS) measures the severity of a depressive episode: the higher the score, the more severe the depression. The Best value is 0 and the Worst value is 52.|28 Weeks|"Analysis was conducted on subjects actively participating in the study at the 28-week assessment. The number corresponds to Completed in the Participant Flow section."||points on a scale||Standard Deviation|Mean
709770|NCT00151372|Primary|Composite Antidepressant Score Scale (CAD)|The Composite Antidepressant Score scale (CAD) describes the adequacy of an antidepressant's dosage. Scores range from 0-4 with 0, 1, and 2 signifying subthreshold or non-adequate therapeutic dosages while 3 and 4 signify a therapeutic/adequate dosage. The best value is 4 while the worst value is 0.|28 Weeks|"Analysis was conducted on subjects actively participating in the study at the 28-week assessment. The number corresponds to Completed in the Participant Flow section."||Participants|||Number
709773|NCT00151476|Secondary|Rectal or Pouch Adenoma Burden Based on Polyp Counts|Number of subjects with polyp burden as assessed in most recent prior polyps evaluation: attenuated: <100 polyps, mild: between 100 to 1000 polyps, severe: >1000 polyps. EOS: endoscopic examination closest to end of on-study celecoxib or index period (within 6 months of end of celecoxib or index period and prior to intake of any exclusionary medications after baseline).|Baseline, 6 to 14 months post-baseline, EOS|All subjects; duodenal polyp burden analyzed in terms of severity categories and based on polyp numbers.||particpants|||Number
709774|NCT00151476|Secondary|Duodenal Adenoma Burden as Measured by Spigelman Stage|Number of subjects with polyp burden as assessed in most recent prior polyps evaluation: Spigelman stage provides index of disease severity based on number of polyps, polyp size, histology, and dysplasia; range is Stage 0 (none) to Stage IV (severe). EOS: endoscopic examination closest to end of on-study celecoxib or index period (within 6 months of end of celecoxib or index period and prior to intake of any exclusionary medications after baseline). Spigelman Stage not completed as staging data largely missing; see measure: Duodenal adenoma burden as measured by polyp counts.|Baseline, 6 to 14 months post-baseline, End of study (EOS)|All subjects; Spigelman Stage not completed as staging data largely missing.||participants|||Number
709775|NCT00151476|Post-Hoc|Duodenal Adenoma Burden as Measured by Polyp Counts|Number of subjects with polyp burden as assessed in most recent prior polyps evaluation: attenuated: <100 polyps, mild: between 100 to 1000 polyps, severe: >1000 polyps. EOS: endoscopic examination closest to end of on-study celecoxib or index period (within 6 months of end of celecoxib or index period and prior to intake of any exclusionary medications after baseline). Post-hoc analysis of duodenal polyp burden in terms of severity categories and based on polyp numbers; Spigelman Stage not completed as staging data largely missing (see: Duodenal adenoma burden as measured by Spigelman Stage)|Baseline, 6 to 14 months post-baseline, End of study (EOS)|All subjects; Spigelman Stage not completed as staging data largely missing; duodenal polyp burden analyzed in terms of severity categories and based on polyp numbers.||participants|||Number
709776|NCT00151476|Secondary|Time From Start of Study Follow-up to Time of Conversion From IRA to IPAA|Time (months): [date of IPAA minus date of start of study follow-up plus 1] divided by 30.44.|Baseline, Up to 60 months post-baseline|All eligible subjects with IRA performed prior to start of study follow-up included, except left-censored subjects (had IPAA prior to start of study follow-up); data censored (n=5) for control group subjects (no data).||months||Full Range|Median
709777|NCT00151476|Secondary|Time From Post IRA to Time of Conversion From IRA to IPAA|Time (months): [date of IPAA minus date of prior IRA plus 1] divided by 30.44.|Up to 15 years prior to baseline|All eligible subjects with IRA performed prior to start of study follow-up; data censored (n=5) for control group subjects (no data).||months||Full Range|Median
709787|NCT00151775|Secondary|Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 4 (End of Study)|Mean change from baseline to the end of the open label Period 4 in seated systolic and diastolic blood pressure readings for Cohort A, Cohort B and Cohorts A+B combined.|Day 0 to week 51 (end of study)|Intent to treat population includes participants with at least one visit in Period 4.||mm Hg||Standard Deviation|Mean
709778|NCT00151476|Secondary|Time From Start of Study Follow-up to Time of First FAP-related Adverse Event|Time (months): [date of first FAP-related adverse event, occurring after the date of the most recent prior FAP-related surgery, or date of FAP diagnosis minus date of start of study follow-up plus 1] divided by 30.44. FAP-related adverse event defined as any FAP related cancers, desmoid tumors requiring procedural intervention, hospitalizations or procedural interventions, or death related to FAP (i.e., as a consequence of FAP, FAP complications, or a procedure or drug used to treat FAP-related medical problems).|Baseline, Up to 60 months post-baseline|All eligible subjects included, except left-censored subjects (had any FAP-related adverse event between the date of most recent FAP-related surgical event performed prior to start of study follow-up, or onset of FAP phenotype (no prior FAP-related surgery), and start of study follow-up.||months||Full Range|Median
709779|NCT00151476|Secondary|Time From Most Recent Prior FAP-related Surgical Event or Onset of FAP Phenotype to Time of First FAP-related Adverse Event|Time (months): [date of first FAP-related adverse event, occurring after the date of most recent prior FAP-related surgery, or date of FAP diagnosis minus date of most recent prior FAP-related surgery, or date of FAP diagnosis plus 1] divided by 30.44. FAP-related adverse event defined as any FAP related cancers, desmoid tumors requiring procedural intervention, hospitalizations or procedural interventions, or death related to FAP (i.e., as a consequence of FAP, FAP complications, or a procedure or drug used to treat FAP-related medical problems).|Up to 15 years prior to baseline|All eligible subjects; first FAP-related adverse event (FAP-related cancers, desmoid tumors requiring procedural intervention, hospitalizations, procedural interventions, or death related to FAP) after subject's most recent FAP-related surgical event performed prior to start of study follow-up, onset of FAP phenotype (no prior FAP-related surgery).||months||Full Range|Median
709780|NCT00151476|Secondary|Time From Start of Study Follow-up to Time of First Excisional or Ablational Event for Rectal, Colonic, Pouch, or Duodenal Adenomas|Time (months): [date of first excisional or ablational event for colonic, pouch, or duodenal adenomas, occurring after date of most recent prior FAP-related surgical event, or date of FAP diagnosis minus date of start of study follow-up plus 1] divided by 30.44.|Baseline, Up to 60 months post-baseline|All eligible subjects included, except left censored subjects (had any excisional or ablational event for rectal, colonic, pouch, or duodenal adenomas between date of most recent FAP-related surgical event performed prior to the start of study follow-up, or onset of FAP phenotype [with no prior FAP-related surgery], and start of study follow-up).||months||Standard Deviation|Mean
709781|NCT00151476|Secondary|Time From Most Recent Prior FAP-related Surgical Event or Onset of FAP Phenotype to Time of First Excisional or Ablational Event for Rectal, Colonic, Pouch, or Duodenal Adenomas (Duodenal Adenomatous Polyps)|Time (months): [date of first excisional or ablational event for colonic, pouch, or duodenal adenomas occuring after date of most recent prior FAP-related surgical event or date of FAP diagnosis minus date of most recent prior FAP-related surgical event or date of FAP diagnosis plus 1] divided by 30.44.|Up to 15 years prior to baseline|All eligible subjects; first excisional or ablational event for rectal adenomas that does not qualify for primary efficacy endpoint; after most recent FAP-related surgical event prior to start of study follow-up or onset of FAP phenotype for subjects with no prior FAP-related surgery.||months||Standard Deviation|Mean
709782|NCT00151476|Primary|Time From Start of Study Follow-up to Time of First Excisional Polypectomy of a Rectal Polyp Post IPAA|Time (months): [date of first excisional polypectomy of rectal polyp post IPAA minus date of start of study follow-up plus 1] divided by 30.44.|Baseline, Up to 60 months post-baseline|All eligible subjects with IPAA performed prior to start of study follow-up included, except left-censored subjects (had first excisional polypectomy post IPAA prior to start of study follow-up). No control group subjects (n=7) had a post-IPAA polypectomy (no data).||months||Standard Deviation|Mean
709783|NCT00151476|Primary|Time From Ileopouch Anal Anastomosis (IPAA) to Time of First Excisional Polypectomy of a Rectal Polyp Post IPAA|Time (months): [date of first excisional polypectomy of a rectal polyp post IPAA minus date of prior IPAA plus 1] divided by 30.44. Baseline = start of study follow-up: start of on-study celecoxib treatment period for celecoxib-treated subjects and comparable to index date for control subjects. Index date calculated as Matched Celecoxib-treated patients: number of days from most recent FAP-related surgery (IRA or IPAA) to start of study follow-up; add this number of days to matched control patient’s most recent FAP-related surgery date=index date for Matched Control.|Up to 15 years prior to baseline|All eligible subjects with IPAA performed prior to start of study follow-up included and with first excisional polypectomy of a rectal polyp post IPAA. No control group subjects (n=7) had a post-IPAA polypectomy (no data).||months||Standard Deviation|Mean
709784|NCT00151476|Primary|Time From Start of Study Follow-up to the Time of First Excisional Polypectomy of a Rectal Polyp Post IRA|Time(months): [date of first excisional polypectomy of rectal polyp post IRA minus date of start of study follow-up plus 1] divided by 30.44.|Baseline, Up to 60 months post-baseline|All eligible subjects with IRA performed prior to start of study follow-up included, except left-censored subjects (had first excisional polypectomy of rectal polyp post IRA prior to start of study follow-up). No control group subjects (n=3) had a post-IRA polypectomy (no data).||months||Full Range|Median
709785|NCT00151476|Primary|Time From Ileorectal Anastomosis (IRA) to Time of First Excisional Polypectomy of a Rectal Polyp Post IRA|Time(months): [date of first excisional polypectomy of rectal polyp post IRA minus date of prior IRA plus 1] divided by 30.44. Baseline = start of study follow-up: start of on-study celecoxib treatment period for celecoxib-treated subjects and comparable to index date for control subjects. Index date calculated as Matched Celecoxib-treated patients: number of days from most recent FAP-related surgery (IRA or IPAA) to start of study follow-up; add this number of days to matched control patient’s most recent FAP-related surgery date=index date for Matched Control.|Up to 8 years prior to baseline|All eligible subjects with IRA performed prior to start of study follow-up; first excisional polypectomy of rectal polyp post IRA. Polyp size unavailable for many subjects; not considered in analysis.||months||Standard Deviation|Mean
709786|NCT00151775|Secondary|Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 4 (End of Study)|Mean change from baseline to the end of the open label Period 4 in seated systolic and diastolic blood pressure readings for Cohort C.|Day 0 to week 51 week (end of study)|57=the number of participants who received medication in Period 4||mm Hg||Standard Deviation|Mean
709819|NCT00133809|Primary|The Number of Insulin-Independent Subjects at One Year Following Islet Cell Transplantation|Independence from insulin injections is measured by the actual use of insulin by the study participants.|one year after transplant|||participants|||Number
709788|NCT00151775|Secondary|Mean Change From Period 3 Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 3|Mean change from period 3 baseline (completion of the dose adjustment period and prior to starting the treatment of period 3) to the end of period 3 (double-blind placebo-controlled period) in seated systolic and diastolic blood pressure readings for Cohort C.|Week 3 (period 3 baseline) to week 5 (end of Period 3)|Intent to treat population defined as subjects who finished Period 2, had the end of Period 2 seated systolic or diastolic blood pressure measurement, took the Period 3 study medication for at least one week, and had the end of Period 3 seated systolic or diastolic blood pressure measurement.||mm Hg||Standard Deviation|Mean
709789|NCT00151775|Secondary|Mean Change From Period 3 Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 3|Mean change from period 3 baseline (completion of the dose adjustment period and prior to starting the treatment of period 3) to the end of period 3 (double-blind placebo-controlled period) in seated systolic and diastolic blood pressure readings for Cohort A, Cohort B and Cohorts A+B combined.|Week 3 (period 3 baseline) to week 5 (end of Period 3)|Intent to treat population defined as subjects who finished Period 2, had the end of Period 2 seated systolic or diastolic blood pressure measurement, took the Period 3 study medication for at least one week, and had the end of Period 3 seated systolic or diastolic blood pressure measurement.||mm Hg||Standard Deviation|Mean
709790|NCT00151775|Primary|Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 2 (3 Weeks)|Mean change from baseline to the end of the dose ranging period in systolic and diastolic blood pressure readings for Cohort A, Cohort B and Cohorts A+B combined.|Day 0 (baseline) to 3 weeks|The Intent-to-Treat (ITT) population for Period II of the study was defined as subjects who took at least one dose of study medication and had study baseline and at least one seated systolic, or diastolic blood pressure measurement after taking study medication. The Last Observation carried forward was used||mm Hg||Standard Deviation|Mean
709791|NCT00151775|Primary|Least Squares Mean Change From Baseline in Seated Systolic Blood Pressure to the End of Period 2 (3 Weeks)|The efficacy dose response change in trough seated systolic blood pressure (both non-weight adjusted and weight adjusted results) from baseline to the end of the dose-ranging period (Period 2). Non-weight adjusted dose was the fixed olmesartan medoxomil dose; weight adjusted dose calculated mg of olmesartan medoxomil per kg of weight at baseline.|Day 0 to 3 weeks|The number of participants includes all randomized to Cohort A, Cohort B and a combination of the two cohorts. The Last Observation Carried Forward method was used in the linear regression analysis for the change in the seated systolic blood pressure from baseline to the end of three weeks.||mm Hg||Standard Error|Least Squares Mean
709792|NCT00151814|Primary|For Olmesartan, the Apparent Oral Volume of Distribution||PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing|24 participants were enrolled; however, the data for the four 2-5 years old participants were not analyzed.||L||Standard Deviation|Mean
709793|NCT00151814|Primary|For Olmesartan, the Apparent Oral Clearance||PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing|24 participants were enrolled; however, the data for the four 2-5 years old participants were not analyzed.||L/hr||Standard Deviation|Mean
709794|NCT00151814|Primary|For Olmesartan, the Elimination Half-life of the Drug in Plasma||PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing|24 participants were enrolled; however, the data for the four 2-5 years old participants were not analyzed.||hr||Standard Deviation|Mean
709795|NCT00151814|Primary|Foe Olmesartan, the Time of Maximum Plasma Concentration||PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing|24 participants were enrolled; however, the data for the four 2-5 years old participants were not analyzed.||hr||Standard Deviation|Mean
709796|NCT00151814|Primary|For Olmesartan, the Maximum Plasma Concentration Over the Entire Sampling Phase||PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing|24 participants were enrolled; however, the data for the four 2-5 years old participants were not analyzed.||ng/mL||Standard Deviation|Mean
709797|NCT00151814|Primary|For Olmesartan, the Elimination Constant Rate||PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing|24 participants were enrolled; however, the data for the four 2-5 years old participants were not analyzed.||L/hr||Standard Deviation|Mean
709798|NCT00151814|Primary|For Olmesartan, Area Under the Concentration-time Curve From the Time of the Dose to Infinity||PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing|24 participants were enrolled; however, the data for the four 2-5 years old participants were not analyzed.||ng/mL*hr||Standard Deviation|Mean
709799|NCT00151814|Primary|For Olmesartan, the Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC 0-t)||PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing|24 participants were enrolled; however, the data for the four 2-5 years old participants were not analyzed.||ng/mL*hr||Standard Deviation|Mean
709800|NCT00151892|Secondary|Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Total Score|Quality of life (QoL) was assessed using the SIBDQ. SIBDQ total score is calculated from the sum of 10 questions. Each question is scored on a scale from 1 (poor QoL) to 7 (good QoL) with total scores ranging from 10 to 70. Higher scores indicate better QoL.|6 Months|Intent to treat (ITT) population defined as all randomized subjects who received at least 1 dose of investigational product. Analysis includes patients who completed an SIBDQ questionnaire at 6 months.||Units on a scale||Standard Deviation|Mean
709801|NCT00151892|Secondary|Change From Baseline in Modified Ulcerative Colitis Disease Activity Index (UCDAI) Score at 6 Months|The modified UCDAI score is the sum of the scores of 4 parameters (stool frequency, rectal bleeding, endoscopy score, and physician global assessment), each scoring between 0 and 3, making 12 the worst score.|Baseline and 6 months|PP||Units on a scale||Standard Deviation|Mean
709802|NCT00151892|Secondary|Endoscopic Remission of UC With No or Mild Symptoms at 6 Months|Endoscopic remission with no or mild symptoms is defined as an endoscopy score of less than or equal to 1 and a combined symptom score (stool frequency plus rectal bleeding) of less than or equal to 1. Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal, 1 = mild , 2 = moderate, 3 = severe). Rectal bleeding is assessed on a scale from 0-3 (0 = no rectal bleeding, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood). Stool frequency is assessed on a scale of 0-2 (0 = 0-1 more than normal per day, 1 = 2-3 more than normal per day, 2 = 4 or more than normal per day).|6 Months|PP||percent of participants|||Number
709803|NCT00151892|Secondary|Withdrawal Due to Relapse of UC|Relapse is defined as withdrawal from the study due to lack of efficacy.|Over 6 Months|PP||percent of participants|||Number
709804|NCT00151892|Primary|Endoscopic Remission of Ulcerative Colitis (UC) at 6 Months|Endoscopic remission is defined as an endoscopy score of less than or equal to 1. Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal [intact vascular pattern; no friability or granulation], 1 = mild [erythema; decreased vascular pattern; minimal granularity], 2 = moderate [marked erythema; granularity; friability; absent vascular pattern; bleeding with minimal trauma; no ulcerations], 3 = severe [ulceration; spontaneous bleeding].|6 Months|Per Protocol Population (PP) defined as all subjects who either completed the study or withdrew for reasons related to efficacy or AEs and who were deemed to be protocol-compliant.||percent of participants|||Number
709805|NCT00151996|Secondary|Change From Baseline in Child Health Questionnaire-Parent Form (CHQ-PF50) Scores at 6 Weeks|The Child Health Questionnaire-Parent Form (CHQ-PF50) was developed to measure the physical and psychosocial well-being of children aged 5 years of age and older. Total scoring ranges from 0-100 for each. Increases in scores represent improved well-being in subjects as assessed by their parents.|Baseline and 6 weeks|FAS||Units on a scale||Standard Deviation|Mean
709806|NCT00151996|Secondary|Number of Participants With Improvement on Parent Global Assessment (PGA) Scores|Parent Global Assessment (PGA) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). The PGA is designed to capture parent's opinions of their child's disease (ADHD) severity and improvement. Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|6 weeks|FAS||Participants|||Number
709807|NCT00151996|Secondary|Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) Total Score at 6 Weeks|The Conner's Parent Rating Scale-revised short version (CPRS-R) consists of 27 questions graded on a scale from 0 (not true at all) to 3 (very much true) with a total score ranging from 0 to 81. Higher scores are indicative of increased ADHD. This scale allows parents to respond on the basis of the child's behavior and help assess ADHD and evaluate problem behavior.|Baseline and 6 weeks|FAS||Units on a Scale||Standard Deviation|Mean
709808|NCT00151996|Secondary|Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|6 weeks|FAS||Participants|||Number
709809|NCT00151996|Primary|Change From Baseline in the Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Total Score at 6 Weeks|Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|Baseline and 6 weeks|Full Analysis Set (FAS) defined as all subjects with a baseline and at least one post-baseline efficacy measurement.||Units on a Scale||Standard Deviation|Mean
709810|NCT00152009|Secondary|Change From Baseline in Child Health Questionnaire-Parent Form (CHQ-PF50) Score at 5 Weeks|The Child Health Questionnaire-Parent Form (CHQ-PF50) was developed to measure the physical and psychosocial well-being of children aged 5 years of age and older. Total score ranges from 0-100. Increases in scores represent improved well-being in subjects as assessed by their parents.|Baseline and 5 weeks|ITT||Units on a scale||Standard Error|Least Squares Mean
709811|NCT00152009|Secondary|Number of Participants With Improvement in Parent Global Assessment (PGA)|Parent Global Assessment (PGA) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|up to 5 weeks|ITT||Participants|||Number
709812|NCT00152009|Secondary|Number of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I)|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|up to 5 weeks|ITT||Participants|||Number
709813|NCT00152009|Secondary|Change From Baseline in Conner's Teacher Rating Scale-revised Short Version (CTRS-R) Score at Up to 5 Weeks|The Conner's Teacher Rating Scale-revised short version (CTRS-R) consists of 28 questions graded on a scale from 0 (not true at all) reflecting no symptoms to 3 (very much true) reflecting severe symptoms with a total score ranging from 0 to 84. Higher scores are indicative of increased ADHD. This scale allows teachers to respond on the basis of the child's behavior and help assess ADHD and evaluate problem behavior.|Baseline and up to 5 weeks|ITT||Units on a Scale||Standard Error|Least Squares Mean
709814|NCT00152009|Secondary|Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) Score at Up to 5 Weeks|The Conner's Parent rating Scale-revised short version (CPRS-R) consists of 27 questions graded on a scale from 0 (not true at all) reflecting no symptoms to 3 (very much true) reflecting severe symptoms with a total score ranging from 0 to 81. Higher scores are indicative of increased ADHD. This scale allows parents to respond on the basis of the child's behavior and help assess ADHD and evaluate problem behavior.|Baseline and up to 5 weeks|ITT||Units on a Scale||Standard Error|Least Squares Mean
709815|NCT00152009|Primary|Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Score at Up to 5 Weeks|Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|Baseline and up to 5 weeks|Intent to treat (ITT) defined as all subjects who were randomized to treatment and had the baseline and at least one post-randomization primary efficacy measurement.||Units on a Scale||Standard Error|Least Squares Mean
709816|NCT00133809|Secondary|The Number of Subjects Exhibiting Fasting C-peptide Levels ≥ 0.5 ng/mL|Number of Participants With Endogenous Insulin Production Post-transplant, Assessed by Fasting C-peptide Levels at 1, 3, 6, 9,12,18, 24, 36, 48 and 60 months after islet cell transplantation|1, 3, 6, 9,12,18, 24, 36, 48 and 60 months post-transplantation|||participants|||Number
709817|NCT00133809|Secondary|Number of Subjects With HbA1C ≤ 6.5%|HbA1C was assessed in subjects 1, 3, 6, 9,12,18,24, 36, 48 and 60 months after transplantation and the number of subjects with values ≤ 6.5% was recorded which indicated better control of blood glucose levels.|1, 3, 6, 9,12,18,24, 36, 48 and 60 months post-transplantation|||participants|||Number
709818|NCT00133809|Secondary|Number of Insulin-independent Subjects Following Islet Transplantation|Participants who did not need to take insulin at 1, 3, 6, 12, 18, 24, 36, 48 and 60 months following islet transplantation|1, 3, 6, 9,12,18, 24, 36, 48 and 60 months post-transplantation|||participants|||Number
709927|NCT00140244|Secondary|Viral Load||At the end of each two month intervention|||copies/ml||Standard Error|Mean
709820|NCT00133952|Secondary|Number of Participants Requiring Repeat Focal Photocoagulation at Any Time From Baseline Though Month 24|Repeat focal photocoagulation is defined as 2 or more focal photocoagulation treatments needed during the study.|Baseline through 24 months|All randomized participants who took at least 1 dose of study drug and had post-baseline determination of focal photocoagulation treatment.||participants|||Number
709821|NCT00133952|Secondary|Number of Participants Not Requiring Focal Photocoagulation at Any Time From Baseline Through Month 24||Baseline through 24 months|All randomized participants who took at least 1 dose of study drug and had post-baseline determination of focal photocoagulation treatment.||participants|||Number
709822|NCT00133952|Secondary|Number of Participants Requiring Focal Photocoagulation at Any Time From Baseline Through Month 24||Baseline through 24 months|All randomized participants who took at least 1 dose of study drug and had post-baseline determination of focal photocoagulation treatment.||participants|||Number
709823|NCT00133952|Secondary|Change From Baseline to Month 24 in Retinal Thickness at the Center of the Macula||Baseline, up to 24 months|All randomized participants who took at least 1 dose of study drug and had both baseline and post-baseline retinal thickness measurements, last observation carried forward (LOCF).||micrometer (µm)||Standard Deviation|Mean
709824|NCT00133952|Secondary|Change From Baseline to Month 24 in Contrast Sensitivity|Values are presented as changes in the number of letters read correctly on the Pelli-Robson contrast sensitivity chart which consists of 16 triplets (48 letters total) with letters of the same size but decreasing contrast. Least Squares (LS) Mean values were controlled for treatment, pooled center, and baseline value.|Baseline, 24 months|All randomized participants who took at least 1 dose of study drug and had both baseline and post-baseline contrast sensitivity measurements.||letters read correctly||Standard Error|Least Squares Mean
709825|NCT00133952|Secondary|Time to Focal Photocoagulation||Baseline through 48 months|All randomized participants who took at least 1 dose of study drug and had post-baseline determination of focal photocoagulation treatment.||months||95% Confidence Interval|Median
709826|NCT00133952|Secondary|Number of Eyes With Significant Center-Involved Macular Edema at Any Time From Baseline Through Month 24|Significant center-involved macular edema is defined as an absolute retinal thickness at the center of the macula >2 standard deviations above the mean baseline value (where the mean and standard deviation are calculated at baseline from the randomized population of participants with retinal thickness values of ≤ 300 microns in depth).|Baseline through 24 months|All randomized participants who took at least 1 dose of study drug and had post-baseline macular edema measurements.||Eyes|Participants||Number
709827|NCT00133952|Secondary|Change From Baseline to Month 24 in Mean Retinal Thickness Within 500 Microns of the Center of the Macula|Least Squares (LS) Mean values were controlled for treatment, pooled center, and baseline value.|Baseline, 24 months|All randomized participants who took at least 1 dose of study drug and had both baseline and post-baseline retinal thickness measurements.||micrometer (µm)||Standard Error|Least Squares Mean
709828|NCT00133952|Primary|Percentage of Participants With Sustained Moderate Visual Loss (SMVL) Any Time Baseline Through Month 48|SMVL is defined as a 15 letter or more decrease from baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity that is sustained for the participant's last 6 months of study participation. ETDRS visual acuity uses an eye chart with 5 letters per line. The scores range from 0 (no letters read correctly) to 100 (all letters read correctly).|Baseline through 48 months|All randomized participants who took at least 1 dose of study drug and had post-baseline SMVL measurements.||percent of participants|||Number
709829|NCT00133978|Secondary|Hospital Length of Stay|Measure of the duration of the participant's hospital stay|6 months (from ICU admission)|||days||Inter-Quartile Range|Median
709830|NCT00133978|Secondary|ICU Acquired Infection|We have made some modifications the definitions developed by the International Sepsis Forum Consensus Conference (CCM 2005;33:1538-1548) to operationalize the adjudication of infections in this trial. We grade the certainty of the diagnosis of infection using definitions for ‘Definite’, ‘Probable’, and ‘Possible’ for each category of infection. The categories of infection are: Deep surgical wound infection, Incisional (or superficial) surgical wound infection, Skin and soft-tissue infection (non-surgical) (SSTS), Catheter-related blood stream infections (CRI), Primary blood stream infections (BSI), Lower urinary tract infection, Upper urinary tract infection, Intra abdominal infection, Sinusitis, Lower respiratory tract infection (excluding pneumonia), ICU Acquired Pneumonia and Other.|Day 28|||participants|||Number
709831|NCT00133978|Secondary|ICU Length of Stay|Measure of the duration of participant stay in the ICU|Day 28|||days||Inter-Quartile Range|Median
709832|NCT00133978|Primary|28-day Mortality|28-day mortality/status: at 28 days after randomization;|Day 28|||participants|||Number
709833|NCT00134004|Secondary|Hematologic and Non-hematologic Toxicities as Measured by NCI Common Toxicity Criteria for Adverse Events, v 3.0 Weekly Until 1 Year After Transplantation|Percentage of study participants who experienced a serious adverse event (SAE) within 1 year of bone marrow transplant. Complete data is provided in the Adverse Event tables.|1 year|||percentage of participants|||Number
709834|NCT00134004|Secondary|Graft Failure Rate|Percentage of participants who experienced failure to engraft (also called graft failure or graft rejection). Failure to engraft is defined as <5% donor chimerism and absence of relapse or any other reason for that chimerism value. All participants who met this criterion were included in this outcome measure.|Cumulative incidence for the entire study, up to 11 years|||percentage of participants|||Number
709835|NCT00134004|Primary|Progression-free Survival|Percentage of participants who do not experience disease relapse, disease progression, or death.|2 years|||percentage of participants|||Number
709836|NCT00134004|Primary|Relapse Rate|Percentage of participants who experience disease relapse.|Cumulative incidence for the entire study, up to 11 years|||percentage of participants|||Number
709837|NCT00134004|Primary|Transplant-related Mortality|Percentage of participants who die for any reason other than recurrence of disease.|Cumulative incidence for the entire study, up to 11 years|||percentage of participants|||Number
709838|NCT00134043|Primary|Objective Response Rate (PR + CR) Using RECIST/WHO Response Criteria|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR., or similar definition that is accurate and appropriate."|Up to 3 years|Per RECIST (Response Evaluation Criteria in Solid Tumors)||percentage of participants|||Number
709839|NCT00134056|Other Pre-specified|Number of Patients With a Change in Functional Status|Functional status will be measured with the Functional Assessment of Cancer Therapy-Prostate (FACT-P) Trial Outcome Index. The FACT-P also addresses four general domains of QOL (physical, functional, emotional, and social well-being subscales) as well as symptom concerns associated with prostate cancer and its treatment.|up to 18 months study period|||Participants|||Count of Participants
709840|NCT00134056|Other Pre-specified|Compare Elements of Quality of Life Between Treatment Arms: Pain Palliation Response, as Measured by the Brief Pain Inventory (BPI)|"Pain palliation is the proportion of patients showing a two-point reduction in the Worst Pain score (WPS) maintained for two consecutive assessments with no increase in analgesic use. Increase in analgesic use is defined as an increase in Analgesic code Level to 2 (weak opioid) or 3 (strong opioid). Patients will be classified as pain palliated or not palliated. Patients with a WPS of 0 will be defined as stable if their WPS remains 0 for Weeks 7 and 10 with no increase in analgesic use, but they will not be categorized as responders. Pain palliation response is measured by BPI short form that has the following: yes/no question about pain today; 4 pain rating questions (worst pain, least pain, average pain, and current pain); pain medications and pain relief; 7 items addressing effect of pain on functioning. For patients who continue to receive treatment beyond 12 treatment cycles, the Worst Pain item is measured by Pain Medication Log and Pain Assessment"|up to 18 months study period|There was a large amount of missing data points due to the difficulty of data collection of pain medication logs in addition to a questionnaire.The study team and site staff were only able to obtain complete data for the patients included in this analysis.||Participants|||Count of Participants
709841|NCT00134056|Secondary|Compare Objective Responses Between the Two Treatment Groups in Patients With Measurable Disease as Defined by RECIST Criteria.|Complete Response (CR): Complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Normalization of markers and other abnormal lab values. PSA ≤ .2 ng/ml. Partial Response (PR): Applies only to patients with at least one measurable lesion. Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions.|Up to 52 weeks|450 (225 in each arm) of 461 patients with measurable disease at trial enrollment were assessable for response by RECIST.||Participants|||Count of Participants
709842|NCT00134056|Secondary|Compare Prostate Specific Antigen (PSA) Response Rates Between the Experimental Arm and the Standard Arm.|PSA Partial Response: Greater than or equal to 50% reduction in baseline PSA. There must be no evidence of soft tissue progression, or confirmed none disease progression, or pain progression.|Up to 7 years after study opens|||Participants|||Count of Participants
709843|NCT00134056|Secondary|Compare Qualitative and Quantitative Toxicity Between the Two Study Arms|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Assessed every 3 weeks up to 52 weeks|patients with hormone-refractory stage IV prostate cancer and bone metastases treated with docetaxel and prednisone combined with either atrasentan vs placebo||Participants|||Number
709844|NCT00134056|Secondary|Compare Pain Progression Between the Two Study Arms.|Pain progression is defined as patients reporting an increase of at least two Worst Pain points, maintained for at least two consecutive assessments, increase to Level 3 (strong opioid) on the Pain Medication Log Analgesic Code for patients receiving Level 2 (weak opioid) analgesics at randomization, or an increase to Level 2 or 3 analgesics for patients receiving Level 0 or 1 analgesics at randomization.|Up to 52 weeks|Only those patients who progressed on study were included in this analysis. The proportion of patients with pain progression is calculated using number of patients with pain progression as the numerator and the total number of patients who progressed on study as the denominator.||Participants|||Count of Participants
709845|NCT00134056|Primary|Compare Progression-free Survival Between a Control or Standard Therapy Arm of Docetaxel + Placebo + Prednisone With Docetaxel + Atrasentan + Prednisone in Patients With Hormone Refractory Prostate Cancer.|Measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients without progression are censored at date of last contact. Disease progression is defined by confirmed bone disease progression, soft tissue or pain progression.|Up to 7 years after study opens|||months||95% Confidence Interval|Median
709846|NCT00134056|Primary|Compare Survival Between a Control or Standard Therapy Arm of Docetaxel + Placebo + Prednisone With Docetaxel + Atrasentan + Prednisone in Patients With Hormone Refractory Prostate Cancer.|Measured from date of registration to date of death due to any cause. Patient last known to be alive are censored at date of last contact.|Up to 7 years after study opens|||months||95% Confidence Interval|Median
709847|NCT00139477|Primary|Change From Baseline in Plasminogen Activator Inhibitor-1 (PAI-1) at 6 Months|Value at 6 months minus value at baseline. PAI-1 is the primary physiological inhibitor of fibrinolysis and proteolysis. High PAI-1 levels have been linked to thrombosis and fibrosis, insulin resistance and obesity. PAI-1 was measured by ELISA (American Diagnostica, Stamford, CT, USA).|Baseline and 6 months|"1 Subject in the Diet/Exercise plus Metformin, then Diet/Exercise (Pubertal) Group and 1 Subject in the Diet/Exercise, then Diet/Exercise plus Metformin (Pubertal) Group did not have a PAI-1 level available for analysis."||ng/ML||Inter-Quartile Range|Median
709848|NCT00139477|Primary|Change From Baseline in Interleukin 6 (IL-6) at 6 Months|Value at 6 months minus value at baseline. IL-6 is a pro-inflammatory cytokine thought to produce a state of low-grade inflammation in obese individuals. IL-6 stimulates hepatic production of C-reactive protein (CRP), an acute phase protein which is a sensitive marker for systemic inflammation. IL-6 was measured by enzyme-linked immunosorbent assay (ELISA; R&D Systems, Minneapolis, MN, USA).|Baseline and 6 months|||pg/mL||Inter-Quartile Range|Median
709849|NCT00139477|Primary|Change From Baseline in Fibrinogen at 6 Months|Value at 6 months minus value at baseline. Fibrinogen is a hepatic-derived factor directly involved in clotting and in the viscosity characteristics of blood flow. It binds to platelets and contributes to their aggregation, promotes fibrin formation and is also an acute phase reactant that is increased in inflammatory states. Fibrinogen concentrations were measured in our laboratory by immuno-nephelometry (Siemens Healthcare Diagnostics, Deerfield IL, USA).|Baseline and 6 months|"1 Subject in the Diet/Exercise plus Metformin, then Diet/Exercise (Pubertal) Group did not have a Fibrinogen level available for analysis."||mg/dL||Inter-Quartile Range|Median
709928|NCT00140244|Secondary|Lean Body Mass|lean body mass|At the end of each two month intervention|||kg||Standard Error|Mean
709929|NCT00140244|Secondary|Insulin Levels||At the end of each two month intervention|||mcIU/ml||Standard Error|Mean
709850|NCT00139477|Primary|Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) at 6 Months|Value at 6 months minus value at baseline. HsCRP is an acute phase protein which is a sensitive marker for systemic inflammation. HsCRP concentrations were measured in our laboratory by immuno-nephelometry (Siemens Healthcare Diagnostics, Deerfield IL, USA), with an hsCRP lower sensitivity of 0.156 mg/L.|Baseline and 6 months|"1 Subject in the Diet/Exercise plus Metformin, then Diet/Exercise (Pubertal) Group did not have an hsCRP level available for analysis."||mg/dL||Inter-Quartile Range|Median
709851|NCT00139477|Primary|Protocol #1: Serum Marker Levels Between Obese and Lean Children|This outcome measure is from Protocol #1 (a cross-sectional study); results are not posted.|Screening Visit||||||
709852|NCT00139659|Primary|Change From Baseline in Post-Bronchodilator Carbon Monoxide Diffusing Capacity (DLco)|Carbon Monoxide Diffusing Capacity (DLco) measured in milliters/minutes/millimeters of mercury (mL/min/mmHg) 30 minutes following the administration of albuterol. Change from Baseline: mean DLco (mL/min/mmHg) at observation minus baseline value.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52, Week 52 Last Observation Carried Forward (LOCF)|Full analysis set (FAS); LOCF: last observation carried forward.||mL/min/mmHg||Standard Deviation|Mean
709853|NCT00139659|Primary|Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in One Second (FEV1)|Change from Baseline at each visit in post-bronchodilator forced expiratory volume in one second (FEV1). FEV1 was measured in liters (L) 30 minutes following the administration of albuterol. Change from baseline: mean FEV1 (L) at observation minus baseline value.|Baseline through Week 52 Last Observation Carried Forward (LOCF)|Full analysis set (FAS): all subjects who were randomized, had a baseline post-albuterol pulmonary function test (PFT) measurement, and had at least two post-baseline, post-albuterol PFT measurements. LOCF: last observation carried forward.||liters||Standard Deviation|Mean
709854|NCT00139659|Secondary|Severe Hypoglycemic Event Rates|Severe hypoglycemic event = all 3 of the following criteria were met: subject unable to treat self, exhbited at least 1 neurological symptom (memory loss, confusion, uncontrollable behavior, irrational behavior, unusual difficulty in awakening, suspected seizure, loss of consciousness); blood glucose measurement was ≤ 49 mg/dL, or not measured but clinical manifestations reversed by oral carbohydrates, subcutaneous glucagon, or i.v. glucose. Crude event rate = number of events divided by 100 subject-months. Subject months = elapsed number of months subject was in study in each time interval.|0 to 1 month to 11 to 12 months, and Overall|Full analysis set (FAS). Due the small number of events severe hypoglycemic event rates were assessed per 100 months.||Number of events/100 subject-months.|||Number
709855|NCT00139659|Secondary|Hypoglycemic Event Rates|A Hypoglycemic event was identified by characteristic symptoms of hypoglycemia with no blood glucose check with prompt resolution with food intake, subcutaneous glucagon, or intravenouus glucose; characteristic symptoms with blood glucose of 59 milligrams per deciliter (mg/dL) (3.2 mmol/L) or less with blood glucose check; or any glucose measurement of 49 mg/dL (2.7 mmol/L) or less, with or without symptoms. Crude event rate = total events divided by subject months. Subject months = elapsed number of months a subject was in the study in each time interval.|0 to 1 month to 11 to 12 months, and Overall|Full analysis set (FAS)||events / subject-months|||Number
709856|NCT00139659|Secondary|Lipids: Median Change From Baseline to Last Observation|Lipids: median changes (milligrams per deciliter [mg/dL]) from Baseline median to last observation in cholesterol (random), triglycerides (random), high density lipoprotein (HDL) cholesterol and low density lipoprotein (LDL) cholesterol. Normalized data was used in the computations. Last observation = last observation while on study drug or during the lag. Measures of dispersion for median changes in lipids were not determined.|Baseline to Last Observation|Primary analysis set (PAS); median change from Baseline to last observation. Last observation was defined as last observation while on study drug or during the lag. Full range (-999 to 999) was not calculated.||mg/dL|||Number
709857|NCT00139659|Secondary|Total Daily Short-Acting Insulin Dose Adjusted for Body Weight|Total Daily Short-Acting Insulin Dose adjusted for body weight (units divided by kg). Short-acting insulin (mg) for the Inhaled Insulin group was Inhaled Insulin. Short-acting insulin (unit) for the Subcutaneous Insulin group included Insulin Lispro, Insulin Aspart, and Regular Insulin.|Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 12, Week 18, Week 26, Week 39, Week 52|Primary analysis set (PAS)||mg/kg, units/kg||Standard Deviation|Mean
709858|NCT00139659|Secondary|Total Daily Short-Acting Insulin Dose (Unadjusted for Body Weight)|Average Total Daily Insulin Dose: short-acting insulin (milligrams [mg]). Short-acting insulin (mg) for the Inhaled Insulin group was Inhaled Insulin. Short-acting insulin (unit) for the Subcutaneous Insulin group included Insulin Lispro, Insulin Aspart, and Regular Insulin.|Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 12, Week 18, Week 26, Week 39, Week 52|Primary analysis set (PAS)||mg, units||Standard Deviation|Mean
709859|NCT00139659|Secondary|Total Daily Long-Acting Insulin Dose Adjusted for Body Weight|"Total daily dose of long-acting insulin adjusted for body weight (units per kilogram [kg]). Long-acting insulin included Insulin NPH, Ultralente, and Insulin Glargine for both groups.
Inhaled Insulin reported in mg/kg. Subcutaneous Insulin reported in units/kg."|Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 12, Week 18, Week 26, Week 39, Week 52|Primary analysis set (PAS)||mg/kg, units/kg||Standard Deviation|Mean
709860|NCT00139659|Secondary|Total Daily Long-Acting Insulin Dose (Unadjusted for Body Weight)|"Total Daily Long-Acting Insulin Dose Unadjusted for Body Weight: long-acting insulin included Insulin NPH, Ultralente, and Insulin Glargine for both groups.
Inhaled Insulin reported in mg. Subcutaneous Insulin reported in units."|Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 12, Week 18, Week 26, Week 39, Week 52|Primary analysis set (PAS)||mg, units||Standard Deviation|Mean
709861|NCT00139659|Secondary|Body Weight: Mean Baseline and Change From Baseline|Body weight: mean Baseline and change from Baseline in kilograms (kg). Change from baseline = mean body weight in kilograms (kg) at observation minus baseline value.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 11, Week 12, Week 18, Wek 26, Week 39, Week 50, Week 51, Week 52, Week 52 Last Observation Carried Forward (LOCF)|Primary analysis set (PAS)||kilograms||Standard Deviation|Mean
709862|NCT00139659|Secondary|Fasting Plasma Glucose|Fasting plasma glucose (milligrams per deciliter [mg/dL]) at Baseline, and change from Baseline. Change from baseline: mean of value of fasting plasma glucose in mg/dL at observation minus baseline value.|Baseline, Week 6, Week 12, Week 26, Week 39, Week 52, Week 52 Last Observation Carried Forward (LOCF)|Primary analysis set (PAS); Last Observation Carried Forward: if the end of study value was missing the last available observation for that subject was used..||mg/dL||Standard Deviation|Mean
709864|NCT00139659|Secondary|Transition Dyspnea Index (TDI): Change in Total Score|Transition Dyspnea Index total score = sum of the numeric grades from the three dyspnea index questions: Change in Functional Impairment, Change in Magnitude of Task, and Change in Magnitude of Effort. Rating scale: -3 (major deterioration), -2 (moderate deterioration), -1 (minor deterioration, 0 (no change), +1 (minor improvement), +2 (moderate improvement), +3 (major improvement).|Week 4, Week 12, Week 26, Week 39, Week 52|Full analysis set (FAS)||scores on scale||Standard Deviation|Mean
709865|NCT00139659|Secondary|Baseline Dyspnea Index (BDI)|Total score = the sum of the numeric grades from the three dyspnea index questions. Functional Impairment rating scale: Grade 4 (no impairment) to Grade 0 (very severe impairment); Magnitude of Task rating scale: Grade 4 (extraordinary) to Grade 0 (no task); and Magnitude of Effort rating scale: Grade 4 (extraordinary) to grade 0 (no effort).|run-in period|Full analysis set (FAS)||scores on scale||Standard Deviation|Mean
709866|NCT00139659|Secondary|Asthma Control as Measured by the Asthma Control Questionnaire©|Asthma Control Questionnaire©: 6 self-administered questions that assess asthma control over the past week covering nocturnal waking, morning symptoms, activity limitations, shortness of breath, wheezing, and short-acting bronchodilator use; 7-point ordinal rating scale from 0 (good control) to 6 (poor control). A seventh question was completed by a health professional on forced expiratory volume in 1 second (FEV1) % predicted using a one-week recall period; scale: 0 (>95% predicted) to 6 (<50% predicted). Overall score = mean of questions 1 - 7.|Baseline, Weeks 4, 12, 26, 39, 52|FAS; abbreviations: Eval = evaluations, BL = Baseline.||scores on scale||Standard Deviation|Mean
709867|NCT00139659|Primary|Annualized Rate of Change for Hemoglobin-adjusted Carbon Monoxide Diffusion Capacity (DLco)|Annualized rates of change (slope throughout time from baseline to end of study[visit]) for hemoglobin-adjusted carbon monoxide diffusion capacity (DLco)in milliliters per minute/millimeters of mercury/year (ml/min/mmHg/yr) measured 30 minutes following the administration of albuterol.|Weeks -3, -2, -1, 1, 2, 3, 4, 6, 12, 18, 26, 39, and 52|Primary analysis set (PAS).||ml/min/mmHg/yr||Standard Error|Mean
709868|NCT00139659|Secondary|Number of Systemic Corticosteroid Rescues|Number of subjects who used a systemic corticosteroid at any time during the study, and the total number of systemic corticosteroid rescues. New rescue event = >=2 consecutive days between the end of one event and the start of another event.|Baseline through Week 52|Full analysis set (FAS); number of subjects with systemic corticosteroid rescues = inhaled insulin: 12, and subcutaneous insulin: 14. Due to inconsistencies in data entry, the numbers of systemic corticosteroid rescues were not considered entirely accurate.||systemic corticosteriod rescues|||Number
709869|NCT00139659|Secondary|Incidence of Severe Asthma Exacerbations|Severe asthma exacerbation was defined as one of the following: subject received oral (systemic) corticosteriods for the treatment of asthma; or subject had an unscheduled visit to a physician, emergency room, or hospital for the treatment of asthma. Subject-months=elapsed number of months a subject was in the study in each time interval. Crude event rate = total events divided by subject-months * 100.|0 to 1 Week to > 12 Months|Full analysis set (FAS); due to inconsistencies in data entry for systemic steroids, the protocol definition for severe asthma exacerbations, which was based on systemic corticosteroid use for asthma, could not be accurately assessed. Due the small number of events the incidence of severe asthma exacerbations was assessed per 100 months.||events/subject months*100|||Number
709870|NCT00139659|Secondary|Incidence of Non-severe Asthma Exacerbations|Non-severe asthma exacerbation = one of the following: any home monitored morning (4:45 am - 10:15 am) forced expiratory volume in 1 second (FEV1) <80% of the morning baseline for 2 or more consecutive days; or home monitored FEV1 <60% of Baseline at any time. Percent of Baseline = 100*(daily FEV1)/Baseline weekly FEV1. Subject-months=elapsed number of months a subject was in the study in each time interval. Crude event rate = total events divided by subject-months.|0 to 1 week to > 12 months|FAS; review of source data for this endpoint showed excessive data variability for home-monitored FEV1 with outliers ranging from 0.01 to >100, and many subjects with random peaks and dips of 100% or more of their baseline. It is unlikely that the protocol definition is robust enough to provide real information about exacerbation frequencies.||events/subject-months|||Number
709871|NCT00139659|Secondary|Mean Weekly Asthma Symptom Scores|Mean weekly asthma symptom scores: subjects recorded their asthma symptom scores in an electronic symptom diary twice daily throughout the study, immediately upon awakening (5-10 AM) and in the evening or at bedtime (7-12 PM). Questions included extent of albuterol use, symptoms of wheezing, coughing, activity limitations and sleep; scale 0 (none/fine) to 3 (severe/ continuous/bad night).|Baseline through end of study|Data for mean weekly asthma symptom scores were not presented due to lack of resource resulting from scaling down of Exubera® (inhaled insulin) development.||scores on scale||Standard Deviation|Mean
709872|NCT00139659|Secondary|Step Classification of Asthma Severity by Medication Usage|Step classification of asthma severity by medication usage. Subjects were classified at each visit according to the medication used on the day of the particular time-point; Step 1: intermittent asthma, Step 2: mild persistent asthma, Step 3: moderate persistent asthma, Step 4: severe persistent asthma. The number (%) of subjects in each step classification were provided at each assessment timepoint with a shift table indicating the number (%) of subjects moving from each step classification at each time-point.|Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 12, Week 18, Week 26, Week 39, Week 52, Week 54, Week 58|Data for step classification of asthma severity by medication usage were not tabulated or analyzed as accurate dose information data for all concomitant medications were not available due to inconsistencies in the way concomitant medication data were collected.||subjects|||Number
709873|NCT00139659|Secondary|Number of Subjects With Step-up and Step-down Changes in Classification of Asthma Severity by Medication Usage|All asthma medication changes during the study were classified as step-up or step-down according to treatment guidelines. Step 1: Intermittant Asthma; Step 2: Mild Persistent Asthma; Step 3: Moderate Persistent Asthma; Step 4: Severe Persistent Asthma. The number of subjects in each step classification of asthma severity were provided at each assessment timepoint for each treatment group, with a shift table indicating the number of subjects moving from each step classification at each timepoint.|Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 12, Week 18, Week 26, Week 39, Week 52, Week 54, Week 58|Data for the number of step-up and step-down changes in classification of asthma severity by medication usage were not tabulated or analyzed as accurate dose information data for all concomitant medications were not available due to inconsistencies in the way concomitant medication data were collected.||subjects|||Number
709930|NCT00140244|Secondary|Fibrinogen|Fibrinogen|At the end of each two month intervention|||mg/dL||Standard Error|Mean
709874|NCT00139659|Secondary|Mean Weekly Number of Puffs of Albuterol Used (Rescue Medication)|All subjects used an electronic symptom diary to record their daily use of short-acting bronchodilators. Subjects recorded the sum of their short-acting bronchodilator use (puffs of albuterol) daily, immediately upon arising, and again in the evening or before bed.|Daily: Baseline to end of study|Mean weekly number of puffs of albuterol was not presented due to lack of resource resulting from scaling down of Exubera® (inhaled insulin) development.||number of puffs||Standard Deviation|Mean
709875|NCT00139659|Secondary|Mean Weekly Morning and Evening Peak Expiratory Flow Rate (PEFR) and Forced Expiratory Volume in 1 Second (FEV1)|Subjects measured peak expiratory flow rate (PEFR) and forced expiratory volume in 1 second (FEV1) twice daily and entered the results in an electronic diary. Daily data were used to calculate the mean PEFR and FEV1 for each week (observed weekly mean and change from baseline in weekly mean). For each subject, the mean weekly morning (and evening) PEFR and FEV1 was defined as the sum of the daily morning (and evening) PEFR (and FEV1) measurements during the week divided by the number of non-missing PEFR (and FEV1) measurements during the week.|Week -3 through Week 52|Mean weekly morning and evening peak expiratory flow rate (PEFR) and forced expiratory volume in 1 second (FEV1) were not presented due to lack of resource resulting from scaling down of Exubera® (inhaled insulin) development.||liters||Standard Deviation|Mean
709876|NCT00139659|Secondary|Methacholine Challenge|Methacholine Challange: performed on a subset of subjects using the 5-breath dosimeter method. Subjects were challenged with ascending doses of nebulized methacholine; dosing schedule: 0.03, 0.06, 0.12, 0.25, 0.5, 1.0, 2.0, 4.0, 8.0, 16.0, 32.0 milligrams per milliliter (mg/ml) administered in 5-minute intervals. Forced expiratory volume in 1 second (FEV1) was measured 1-3 minutes after each inhalation of methacholine solution. Testing continued until highest FEV1 decreased by ≥20% from the challenge (post-diluent) reference, or until completion all doses.|1 to 2 days following Weeks -3 and -1 visits, and at Week 11, Week 50, and Week 52 (+5)|There were no methacholine challenges performed in subjects using inhaled insulin due to protocol-defined exclusion criteria for methacholine challenge testing, and methacholine provocative concentration [of methacholine] causing a 20% fall in FEV1 (PC20) data were not analyzed.||liters||Standard Deviation|Mean
709877|NCT00139659|Secondary|Change From Baseline in Insulin Dose Responsiveness for Carbon Monoxide Diffusing Capacity (DLco) Measured 10 and 60 Minutes After the First Daily Dose of Insulin|Carbon Monoxide Diffusing Capacity (DLco) dose responsivness 10 and 60 minutes after insulin. DLco dose-responsiveness to insulin was defined as the difference between the DLco value following a dose of insulin and DLco value before a dose of insulin, operationally defined as the post-dose DLco value minus pre-dose DLco value.|Baseline, Week 9, Week 51|Full analysis set (FAS)||ml/min/mmHg||Standard Deviation|Mean
709878|NCT00139659|Secondary|Percent Predicted and Percent Change From Baseline in 10 Minute and 60 Minute Post-Insulin Forced Expiratory Volume in One Second (FEV1)|Percent predicted change from Baseline in 10 Minute and 60 Minute post-insulin forced expiratory volume in one second (FEV1) measured in liters (L): National Health and Nutrition Examination Survey (NHANES III) reference standard. Percent change from Baseline in FEV1 measured in liters (L) 10 and 60 Minutes post-insulin. Percent change = (value at observation minus Baseline value) divided by Baseline value *100%.|Baseline, Week 9, Week 51, Week 51 Last Observation Carried Forward (LOCF)|Full analysis set (FAS); LOCF: last observation carried forward.||percent||Standard Deviation|Mean
709879|NCT00139659|Secondary|Change From Baseline in Insulin Dose Responsiveness for Forced Expiratory Volume in One Second (FEV1) Measured 10 and 60 Minutes After the First Daily Dose of Insulin|Change from Baseline in Insulin Dose Responsiveness for Forced Expiratory Volume in one second (FEV1) measured 10 and 60 minutes after the first daily dose of insulin. Insulin dose responsiveness = the difference between FEV1 value following a dose of insulin and FEV1 value before a dose of insulin, operationally defined as the post dose FEV1 value minus predose FEV1 value.|Baseline, Week 9, Week 51|Full analysis set (FAS)||liters||Standard Deviation|Mean
709880|NCT00139659|Secondary|Percent Predicted and Percent Change From Baseline in Post-Bronchdilator Forced Expiratory Volume in One Second (FEV1)|Percent predicted change from Baseline in post-bronchodilator forced expiratory volume in one second (FEV1) measured in liters (L): National Health and Nutrition Examination Survey (NHANES III) reference standard. Percent change from Baseline in post-bronchdilator FEV1 measured in liters (L): (observed value minus Baseline value) divided by Baseline value *100%.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52, Week 52 Last Observation Carried Forward (LOCF)|Full analysis set (FAS); LOCF: last observation carried forward.||percentage of FEV1||Standard Deviation|Mean
709881|NCT00139659|Secondary|Bronchodilator Responsiveness as Determined by the Change in Forced Expiratory Volume in 1 Second (FEV1) Pre-albuterol and 30 Minutes Post-albuterol|Responsiveness was the percent change from the forced expiratory volume in 1 second (FEV1) value before bronchodilator use to the FEV1 value 30 minutes after bronchodilator use, operationally defined as [(post-bronchodilator FEV1 minus pre-bronchodilator FEV1 divided by pre-bronchodilator FEV1] multiplied by 100.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52|Full analysis set (FAS)||percent change in FEV1||Standard Deviation|Mean
709882|NCT00139659|Secondary|Change From Baseline in Post-bronchodilator Forced Vital Capacity (FVC)|Change from baseline in Post-bronchodilator Forced Vital Capacity (FVC) measured in liters (L) 30 minutes following the administration of albuterol: change = FVC at observation minus FVC at Baseline.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52, Week 52 Last Observation Carried Forward (LOCF)|Full analysis set (FAS); LOCF: last observation carried forward.||liters||Standard Deviation|Mean
709883|NCT00139659|Secondary|Change From Baseline in Pre-Insulin Carbon Monoxide Diffusing Capacity (DLco)|Change From Baseline in Pre-Insulin Carbon Monoxide Diffusing Capacity (DLco) measured in milliters/minutes/millimeters of mercury (mL/min/mmHg): change = DLco at observation minus DLco at Baseline.|Baseline, Week 9, Week 51, Week 51 Last Observation Carried Forward (LOCF)|Full analysis set (FAS); LOCF: last observation carried forward.||ml/min/mmHg||Standard Deviation|Mean
709884|NCT00139659|Secondary|Change From Baseline in Pre-Insulin Forced Expiratory Volume in One Second (FEV1)|Change from Baseline in Pre-Insulin Forced Expiratory Volume in one second (FEV1) measured in liters (L): change = FEV1 at observation minus FEV1 at Baseline.|Baseline, Week 9, Week 51, Week 51 Last Observation Carried Forward|Full analysis set (FAS); LOCF: last observation carried forward.||liters||Standard Deviation|Mean
709931|NCT00140244|Secondary|Blood Pressure|percent change in mean blood pressure|At the end of each two month intervention|||percentage change of mean blood pressure||Standard Error|Least Squares Mean
709885|NCT00139659|Secondary|Change From Baseline in Pre-Bronchodilator Carbon Monoxide Diffusing Capacity (DLco)|Change From Baseline in Pre-Bronchodilator Carbon Monoxide Diffusing Capacity (DLco) measured in milliters/minutes/millimeters of mercury (mL/min/mmHg): change = DLco at observation minus DLco at Baseline.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52, Week 52 Last Observation carried Forward (LOCF)|Full analysis set (FAS); LOCF: last observation carried forward.||ml/min/mmHg||Standard Deviation|Mean
709886|NCT00139659|Secondary|Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in One Second (FEV1)|Change from Baseline in Pre-Bronchodilator Forced Expiratory Volume in One Second (FEV1) at each visit. FEV1 was measured in liters (L) before the administration of albuterol. Change from baseline: mean FEV1 (L) at observation minus mean baseline value.|Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52, Week 52 Last Observation Carried Forward (LOCF)|Full analysis set (FAS); LOCF: last observation carried forward.||liters||Standard Error|Mean
709887|NCT00139659|Primary|Annualized Rate of Change for Forced Expiratory Volume in 1 Second (FEV1)|Annualized rates of change (slope throughout time from baseline to end of study[visit]) for forced expiratory volume in 1 second (FEV1) (liters per year [L/yr]) measured 30 minutes following the administration of albuterol.|Weeks -3, -2, -1, 1, 2, 3, 4, 6, 12, 18, 26, 39, and 52|Primary analysis set (PAS): all subjects who were randomized, had no significant protocol violations, had baseline (BL) post-albuterol pulmonary function test (PFT) measurement, had at least 2 post-BL, post-albuterol PFT measurements with 1 measurement at least 6 months post-BL, and received study drug for at least 50% (154 days) of study duration.||L/yr||Standard Error|Mean
709888|NCT00139737|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|All observed or volunteered treatment-emergent AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product were reported.|Baseline up to 72 months|Safety Analysis Set = All subjects who took at least 1 dose of study drug||Participants|||Number
709889|NCT00139776|Other Pre-specified|Serious Adverse Events in Open Label run-in Period|Serious adverse events occuring during the 2 week run-in period (Period II) when all participants were dosed with celecoxib 200 mg daily|2 weeks prior to double blind dosing|1197 participants entered the open-label run-in (period II) to allow observation of successful treatment of an osteoarthritis flare. 875 participants were randomized to double blind treatment (period III). 322 participants were not randomized.||participants|||Number
709890|NCT00139776|Other Pre-specified|Change in the Quality of Life Short Form-12v2 (SF-12v2) Scale Scores - All Assessments|SF-12v2 is a 12 item health survey covering 7 topics. Raw scores are transformed to a 0 to 100 scale. Higher scores indicate better state of health. Score at end of Period III minus score at start of Period III.|Period III|"Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication.
Subjects assessed per scale n=continuous use (cont); n=intermittent use (inter)"||scores on a scale||Standard Deviation|Mean
709891|NCT00139776|Other Pre-specified|Medical Outcomes Study Sleep Scale - Number of Participants With Optimal, Mixed and Not Optimal Sleep|Transformed score scale: 1=optimal; 0=not optimal; mixed = both optimal and non-optimal sleep during Period III|Period III|Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication||participants|||Number
709892|NCT00139776|Secondary|Area Under the Curve (AUCs) of Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores|WOMAC assesses subject responses to 24 components regarding subscales of pain, stiffness and physical function (score range: 0=none to 4= extreme). Total score is sum of the 3 subscale scores. Scores analyzed as area under the curve (AUC) of participant's WOMAC scores from each assessment in Period III.|Period III (22 weeks)|"Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication.
Number of subjects evaluable: continuous use Period III start n=428, end n=427; intermittent use Period III start n=424, end n=424"||scores on a scale * weeks||Standard Deviation|Mean
709893|NCT00139776|Other Pre-specified|Change in Medical Outcomes Study Sleep Scale - All Assessments|Subject assessment on 7 sleep associated categories. Raw scores are transformed to a 0-100 scale. Higher score indicates more of the outcome (e.g. more snoring, more adequate sleep). Score at end of Period III minus score at start of Period III.|Period III|Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication. Subjects assessed per scale n=continuous use (cont); n=intermittent use (inter)||scores on a scale||Standard Deviation|Mean
709894|NCT00139776|Secondary|Change in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores|Score at end of Period III minus score at start of Period III. WOMAC assesses subject responses to 24 components regarding subscales of pain, stiffness and physical function (score range: 0=none to 4= extreme). Total score is sum of the 3 subscale scores. Negative change indicates improvement.|Period III (22 weeks)|Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication. Number of subjects evaluable: continuous use Period III start n=428, end n=427; intermittent use Period III start n=424, end n=424||scores on a scale||Standard Error|Least Squares Mean
709895|NCT00139776|Secondary|Days on Flare Medication|Number of days on flare medication per month per subject calculated as number of days on flare medication divided by the number of days on study medication in Period III|Period III (22 weeks)|"Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication.
Subjects who did not take flare medication were calculated as 0 and included in the analysis.
Number of subjects taking flare medication: continuous use n=282; intermittent use n=339."||days on medication per month per subject||Standard Deviation|Mean
709896|NCT00139776|Secondary|Proportion of Days on Rescue Medication|Days on rescue medication divided by number of days on study medication in Period III|Period III (22 weeks)|"Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication. Number of subjects taking rescue medication: continuous use n=220; intermittent use n=239.
Subjects who did not take rescue medication were calculated as 0 and included in the analysis."||proportion of days||Standard Deviation|Mean
709932|NCT00140244|Secondary|Free Fatty Acid (FFA) Levels||At the end of each two month intervention|||mEq/liter||Standard Error|Mean
709933|NCT00140244|Secondary|Low Density Lipoprotein (LDL) Cholesterol Levels||At the end of each two month intervention|||mg/dl||Standard Error|Mean
709897|NCT00139776|Secondary|Total Rescue Medication Taken (Mean)|Total amount of rescue medication (acetaminophen in milligrams [mg]) taken per month per participant|Period III (22 weeks)|"Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication.
Subjects who did not take rescue medication were assumed to have taken 0mg and were included in the analysis.
Number of subjects taking rescue medication: continuous use n=220; intermittent use n=239."||mg taken per month per participant||Standard Deviation|Mean
709898|NCT00139776|Secondary|Physician's Global Assessment of Arthritis at Final Visit|Physician assessed each participant's disease symptoms on a categorical scale from 1 (very good) to 5 (very poor).|Period III (22 weeks)|Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication||participants|||Number
709899|NCT00139776|Secondary|Patient's Global Assessment of Arthritis|"Participant's response to question Considering all the ways the osteoarthritis in your hip or knee affects you, how are you doing today? on scale from 1 (very good) to 5 (very poor). Scores analyzed as area under the curve (AUC) of participant's scores from each assessment in Period III."|Period III|"Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication.
These data are presented by the weeks from the start of Period II, 2 weeks before randomization. The weeks post-randomization, Period III, are different from the study weeks i.e. includes 2 weeks from Period II."||scores on a scale * weeks||Standard Error|Least Squares Mean
709900|NCT00139776|Secondary|Arthritis Pain Numerical Rating Scale (NRS)|Participant rated intensity of osteoarthritis pain on categorical scale from 0 (no pain) to 10 (worst pain). Scores analyzed as area under the curve (AUC) of participant's scores from each assessment in Period III.|Period III|"Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication.
These data are presented by the weeks from the start of Period II, 2 weeks before randomization. The weeks post-randomization, Period III, are different from the study weeks i.e. includes 2 weeks from Period II."||scores on a scale * weeks||Standard Error|Least Squares Mean
709901|NCT00139776|Secondary|Proportion of Days in Osteoarthritis (OA) Flare|Number of days subject was in OA flare divided by number of days on study medication in Period III. Subjects may have more than one flare. Flare was determined using pre-defined criteria, using an interactive voice response system.|Period III (22 weeks)|||proportion of days in OA flare||Standard Deviation|Mean
709902|NCT00139776|Secondary|Proportion of Days Free From Osteoarthritis (OA) Flare|Number of days subject was free from OA flare divided by number of days on study medication in Period III. Flare was determined using pre-defined criteria, using an interactive voice response system.|Period III (22 weeks)|Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication||proportion of days free from OA flare||Standard Deviation|Mean
709903|NCT00139776|Secondary|Time to Occurrence of First Osteoarthritis (OA) Flare|Time from first dose of double blind medication (start of Period III) to occurrence of first OA flare. Flare was determined using pre-defined criteria, using an interactive voice response system|Period III (22 weeks)|Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication.||days||95% Confidence Interval|Median
709904|NCT00139776|Primary|Number of Flare Events Per Time of Exposure to Study Medication|Number of flare events per month during Period III (calculated as number of flares divided by number of months participant was enrolled during Period III). Flare was determined using pre-defined criteria, using an interactive voice response system.|Period III (22 weeks)|Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication||flare events per month||Standard Deviation|Mean
709905|NCT00139997|Secondary|SIGH SAD (Structured Interview Guide For The Hamilton Depression Rating Scale), SAD Version|SIGH SAD Structured Interview Guide for the Hamilton Depression Rating Scale, SIGH SAD Structured Interview Guide for the Hamilton Depression Rating Scale, Seasonal Affective Disorder (SAD)version. This is a structured interview, which is an interview in which the clinician is provided exact questions to use to inquire about symptoms of depression and explicit standards for rating the intensity of each symptom item. The interview assesses the symptoms which make up the Hamilton Depression Rating Scale, which is the standard in the majority of clinical trials in depression. The items are augmented with additional items to reflect better the atypical depressive symptoms usually seen in SAD, eg, increased sleep, weight, appetite and fatigue. On this scale, higher scores reflect increased depression intensity. The maximum score attainable is 63, and the minimum is 0. A score of less than 9 is regarded as consistent with normal mood, the absence of major depression.|Weekly following randomization|These participants are analyzed ITT- last observation carried forward.||units on a scale||Standard Deviation|Mean
709906|NCT00139997|Primary|Percentage SIGH SAD (Structured Interview Guide For The Hamilton Depression Rating Scale), SAD Version|"SIGH SAD Structured Interview Guide for the Hamilton Depression Rating Scale, Seasonal Affective Disorder (SAD)version. The items are augmented with additional items to reflect better the atypical depressive symptoms usually seen in SAD, eg, increased sleep, weight, appetite and fatigue. On this scale, higher scores reflect increased depression intensity. The maximum score attainable is 63, and the minimum is 0. A score of less than 9 is regarded as consistent with normal mood, the absence of major depression.
Calculated: SIGH SAD score at trial end x 100 / SIGH SAD score at randomization"|Week 4|These participants are analyzed ITT- last observation carried forward.||Percentage of SIGH SAD||Standard Deviation|Mean
709907|NCT00140140|Secondary|Kaplan-Meier Estimates for Participant Survival|Participant survival is the time from the first dose of study drug to participant death from any cause. Participants that did not die were censored at the last known time the participant was alive.|up to 39 months|Treated population||months||95% Confidence Interval|Median
709908|NCT00140140|Secondary|Kaplan Meier Estimate for Progression-Free Survival (PFS)|"PFS was defined as the time from the first dose of study drug to the start of progression or patient death (any cause) whichever occurred first. Participants that did not have progression or have not died were censored at the last known time the participant was progression free. Participants that initiate other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated.
Because no patients died as a result of a non-disease progression event, the analysis of PFS was identical to the analysis for TTP."|up to month 30|Treated population of participants who had disease progression or who died||months||95% Confidence Interval|Median
709909|NCT00140140|Secondary|Kaplan-Meier Estimate for Duration of Response|"Duration of response is defined as progression-free survival in responders, i.e. as the time between the start of a complete response (CR) or partial response (PR) and the start of progressive disease (PD) or patient death from any cause, whichever occurred first. Patients that did not have progression or have not died were censored at the last known time the patient was progression free. Patients that initiate other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated.
Complete response (CR) and partial response (PR) are defined in outcome #1. Progressive disease was defined as at least a 20% increase in the sum of the longest diameters of target lesions; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion."|up to month 30|Treated participants who had a response||months||95% Confidence Interval|Median
709910|NCT00140140|Secondary|Kaplan Meier Estimate for Time to Disease Progression (TTP)|"Time to progression was defined as the time from the first dose of study drug to the start of progression. Participants that did not have progression were censored at the last known time the patient was evaluated for progression. Participants that initiate other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated.
Progressive disease was defined as at least a 20% increase in the sum of the longest diameters of target lesions; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion."|up to month 30|Treated population of participants with disease progression||months||95% Confidence Interval|Median
709911|NCT00140140|Secondary|Percentage of Participants With Stable Disease for >= 16 Weeks, or Complete or Partial Response According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0)|"Disease control is stable disease (SD) for >=16 weeks + complete response (CR) + partial response (PR). See Outcome #1 for definitions of CR and PR.
RECIST defines SD for target lesions as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, no occurrence of progression disease for non-target lesions, and no new lesions."|up to month 30|Treated population||percentage of participants|||Number
709912|NCT00140140|Primary|Nadir Measurement for Hemoglobin (Hgb)|Myelosuppression is a decrease in the ability of the bone marrow to produce blood cells. The lowest observed measurement is the nadir. Blood counts were performed each week of treatment.|up to week 129 (longest treatment)|Treated population||g/L||Standard Deviation|Mean
709913|NCT00140140|Primary|Nadir Measurement for Absolute Neutrophil (ANC), White Blood Cell (WBC) and Platelet Count|Myelosuppression is a decrease in the ability of the bone marrow to produce blood cells. The lowest observed measurement is the nadir. Blood counts were performed each week of treatment.|up to week 129 (longest treatment)|Treated population||10^9/L||Standard Deviation|Mean
709914|NCT00140140|Primary|Participant Counts of the Most Severe Grade for Absolute Neutrophil (ANC), White Blood Cell (WBC), Platelet, and Hemoglobin Counts as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Experience (NCI CTCAE v3)|"Myelosuppression is a decrease in the ability of the bone marrow to produce blood cells. The lowest measured (nadir) blood counts were graded using NCI CTCAE version 3.
ANC:
Grade 0 = within normal limits; Grade 1 = < lower limit of normal – 1.5*10^9/L; Grade 2 = <1.5 - 1.0*10^9/L; Grade 3 = <1.0 - 0.5*10^9/L; Grade 4 = <0.5*10^9/L
WBC:
Grade 0 = within normal limits; Grade 1 = < lower limit of normal - 3.0*10^9/L; Grade 2 = <3.0 - 2.0*10^9/L; Grade 3 = <2.0 – 1.0*10^9/L; Grade 4 = <1.0*10^9/L
Platelets:
Grade 0 = within normal limits; Grade 1 = < lower limit of normal - 75.0*10^9/L; Grade 2 = <75.0 - 50.0*10^9/L; Grade 3 = <50.0 – 25.0*10^9/L; Grade 4 = <25.0*10^9/L
Hemoglobin:
Grade 0 = within normal limits; Grade 1 = < lower limit of normal – 100 g/L ; Grade 2 = <100 – 80 g/L; Grade 3 = <80 – 65 g/L; Grade 4 = <65 g/L"|up to week 129 (longest treatment)|Treated population||participants|||Number
709915|NCT00140140|Primary|Percentage of Participants With Discontinued, Delayed or Interrupted Therapy|Percentage of participants who had discontinued therapy or had a delayed dose or an interrupted (omitted) dose due to toxicities/adverse events.|up to week 129|Treated population||percentage of participants|||Number
709916|NCT00140140|Primary|Participants With Dose Limiting Toxicities|"Toxicities were evaluated based on the U.S. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Any drug-related toxicities CTC Grade 3 or higher were considered dose limiting. Grade 3=severe AE, Grade 4=life-threatening or disabling AE, Grade 5=death. Other conditions considered dose-limiting toxicities include:
requirement of a dose adjustment during the first 4 weeks
a dose delay of >3 weeks during the first 4 weeks Grade 3 or greater toxicities attributed to the use of Herceptin were not considered dose-limiting toxicities.
The optimal tolerated dose of ABI-007 and vinorelbine given concurrently was defined as the dose administered in the absence of DLTs."|up to month 1|Treated population||participants|||Number
709917|NCT00140140|Primary|Participants With Confirmed Complete or Partial Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0)|"Overall response rate (ORR) is complete response (CR) + partial response (PR). Complete response (CR): The disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation. All sites must be assessed, including non-measurable sites, such as effusions, or markers. Disappearance of all non-target lesions. The normalization of tumor marker level confirmed at least 4 weeks after initial documentation.
Partial response (PR): At least a 30% decrease in the sum of the longest diameters of target lesions, taking as a reference the baseline sum of the longest diameters confirmed at least 4 weeks after initial documentation. PR is also recorded when all measurable disease has completely disappeared, but a non-measurable component (i.e., ascites) is still present but not progressing. As well as persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits."|up to month 30|Treated population||percentage of participants||95% Confidence Interval|Number
709918|NCT00140231|Secondary|Autonomic Function|aldosterone level were measured on day 4 in response to leptin in fed and fasting states and compared with baseline level on day 1|four days|||pg/ml||Standard Error|Mean
709919|NCT00140231|Secondary|(RMR)|Resting Metabolic rate using calorimetry|four days|||kcal/d||Standard Deviation|Mean
709920|NCT00140231|Secondary|%Fat Mass||four days|||fat%||Standard Deviation|Mean
709921|NCT00140231|Primary|Immune Function CD3 Count||4 days|||cells/ul||Standard Error|Mean
709922|NCT00140231|Primary|ACTH Mean Level|Response of ACTH to leptin administration in fed and fasting state from baseline was measured|4 days|||pg/ml||Standard Error|Mean
709923|NCT00140231|Primary|Cortisol||four days|||ug/dl||Standard Deviation|Mean
709937|NCT00140413|Primary|Change in Anthropometric Measures Over Time|Primary outcome measures included change in stature, weight, BMI, and weight-for-stature z-scores over the course of the study. Z-score indicates how many standard deviations an element is from the mean. It is calculated as z = (x – µ) σ, where µ is the mean of the population, and σ is the standard deviation of the population. A positive z-score indicates a datum above the mean, while a negative z-score indicates a datum below the mean. All z-scores were obtained using Epi Info ™ 3.5.4. (Centers for Disease Control, Atlanta, GA).|Baseline and 36 months|||Z-score||Inter-Quartile Range|Median
709938|NCT00140426|Primary|Body Image Software (BIS) - Difference Limen (DL)|"Body Image Software (BIS) - the subject adjusts a digital image of themselves on the computer to their desired image, and also completes a task that determines their perception of their current image. Accuracy is measured by a smaller score between desired image and actual image.
Change in BIS-DL was calculated using an estimate of change in score between week 0 and week 7 derived from the mixed effect model across all time points.
There are no identifiable minimum/maximum values as there would be in a questionnaire scale. There are no subscales. Interpreting the DL occurs by referencing it to DL= 0, which would reflect a total inability to detect size differences, which has never occurred in studies using the BIS program."|monthly|Change from baseline to end of study was compared between arms. Some patients did not complete this outcome measurement.||units on a scale||Standard Deviation|Mean
709939|NCT00140426|Primary|Body Image Software (BIS) - Point of Subjective Equality (PSE)|"Body Image Software (BIS) - the subject adjusts a digital image of themselves on the computer to their desired image, and also completes a task that determines their perception of their current image. Accuracy is measured by a smaller score between desired image and actual image.
Change in BIS -PSE was calculated using an estimate of change in score between week 0 and week 7 derived from the mixed effect model across all time points.
There are no identifiable minimum/maximum values as there would be in a questionnaire scale. Interpreting the PSE is how it compares to a PSE = 0, which is no distortion in body size."|monthly|Change from baseline to end of study was compared between arms. Some patients did not complete this outcome measurement.||units on a scale||Standard Deviation|Mean
709940|NCT00140426|Primary|Body Image Software (BIS): Average Desired Thinness|"Body Image Software (BIS) - the subject adjusts a digital image of themselves on the computer to their desired image. The BIS program calculates the difference between their actual image, and how much they have adjusted the image to represent their desired image. Accuracy is measured by a smaller score between desired image and actual image.
Change in BIS - Average Desired Thinness score was calculated using an estimate of change in score between week 0 and week 7 derived from the mixed effect model across all time points.
There are no identifiable minimum/maximum values as there would be in a questionnaire scale. . There are no subscales."|monthly|Many patients did not complete this outcome measurement. Change from baseline to end of study were compared between arms.||units on a scale||Standard Deviation|Mean
709941|NCT00140426|Primary|Body Image Software (BIS): Average Distortion|"Body Image Software (BIS) - the subject adjusts a digital image of themselves on the computer using the direction to adjust their image to how they see themselves right now, this determines their perception of their current image. Accuracy is measured by a smaller score between desired image and actual image.
Change in the BIS Average Distortion score during the study was calculated using an estimate of change in score between week 0 and week 7 derived from the mixed effect model across all time points.
There are no identifiable minimum/maximum values as there would be in a questionnaire scale. There are no subscales. The BIS program calculates the difference between their actual image and the size of the image they have adjusted the digital image to based on their perception of how they see themselves right now"|monthly|Change from baseline to end of study was compared between arms. Some patients did not complete this outcome measurement.||units on a scale||Standard Deviation|Mean
709942|NCT00140426|Primary|Color A Person Test (CAPT)|"Color A Person Test (CAPT) - Subjects color an outlined image of a body to indicate body dissatisfaction (red (5)= very dissatisfied, Yellow, dissatisfied, black, neutral, green satisfied, blue very satisfied (1). The outline is divided into16 sections for scoring. The CAPT was completed at baseline and monthly during study participation.
Total CAPT scores were calculated by adding the total score and dividing by 16. Score range is 1-5. Lower scores indicate less body dissatisfaction.
Change in the CAPT score during the study was calculated using an estimate of change in score between week 0 and week 7 derived from the mixed effect model across all time points."|monthly|||units on a scale||Standard Deviation|Mean
709943|NCT00140426|Secondary|Time to Reach 90% IBW and Maintain for 1 Month, Stratified by IBW <80% at Start of Study|The mean survival time and its standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time. These estimates were produced using Kaplan-Meier probabilities.|0 - 18 weeks|||weeks||Standard Error|Mean
709944|NCT00140426|Secondary|Change in Prolactin Levels|Prolactin serum blood levels, measured in nanograms / ml|week 0 and week 7|||ng/ml||Standard Deviation|Mean
709945|NCT00140426|Secondary|Change in Leptin Levels|Leptin levels were measured by serum blood draws, results reports in nanograms / ml (ng/ml).|Week 0 and week 7|||ng/ml||Standard Deviation|Mean
709946|NCT00140426|Secondary|Change in Ratings of Anxiety Symptoms on the Multidimensional Anxiety Scale for Children (MASC)|"The Multidimensional Anxiety Scale for Children (MASC) is a self report measure completed by the subject that measures anxiety symptoms.
Higher scores indicate greater anxiety. A score of over 50 is significant for anxiety
Change in MASC scores was calculated using an estimate of change in score between week 0 and week 7 derived from the mixed effect model across all time points."|monthly to study end point|||units on a scale||Standard Deviation|Mean
709947|NCT00140426|Secondary|Time to Reach 90% Ideal Body Weight (IBW) and Maintain for 1 Month, Stratified by >=80% at Start of Study|The mean survival time and its standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time. These estimates were produced using Kaplan-Meier probabilities. This was measured weekly from 0-18 weeks.|weekly|||weeks||Standard Error|Mean
709959|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Creatinine|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17||participants|||Number
709948|NCT00140426|Primary|Hazard Ratio for Time to Reaching Ease Of Eating Level 3 From Start of Study (Normal Eating Behavior)|"The Ease of Eating Scale (EOES) is a 14 item scale which measures Food avoidance behaviors (FABs). The scale is rated by staff observing a subject eating a meal or snack. 0 = normal eating behavior, maximum score 28.
Higher scores indicate more food avoidance behaviors, such as taking small bites, taking > 30 seconds between bites (slow eating), etc.
EOE was completed for each meal a subject ate in the program and scores were averaged for each week in the study and entered in the data base.
Change in EOES score was calculated by evaluating change over time. This measure was only used in Phase 1 of the study, for days the subjects were in the treatment program."|weekly up to study endpoint: reaching target weight and maintaining for 1 month|2 patients in the placebo group were treated as inpatients and had no EOE data.||hazard ratio||95% Confidence Interval|Number
709949|NCT00140426|Primary|Change in Eating Disorder Inventory (EDI)-2 Score for Body Dissatisfaction (BD)|"change in Eating Disorder Inventory (EDI) 2-score for Body Dissatisfaction (BD).
Lower scores are better on this scale. Higher scores indicate the subject has greater body dissatisfaction. BD is one of the 8 subscales of the EDI-2. 9 of the 91 questions in the EDI-2 scale constitute this subscale. The score range is 0-27. Subjects completed the EDI-2 at baseline and monthly during study participation (range 0 to 18 weeks). Change in the BD subscale score during the study was calculated using an estimate of change in score between week 0 and week 7 derived from the mixed effect model across all time points."|monthly|1 risperidone subject was missing data for BD at this data point.||units on a scale||Standard Deviation|Mean
709950|NCT00140426|Primary|Change in Eating Disorder Inventory-2 Drive for Thinness Subscale (DT)|"Eating Disorder Inventory -2 - Subscale : Drive for Thinness Subscale (DT). Lower scores are better on this scale and indicate less cognitive focus on drive for thinness.
The EDI 2 is a 91 item scale with 8 subscales - (Drive for thinness, Bulimia, body dissatisfaction, ineffectiveness, perfection, interpersonal distrust, interoceptive awareness and maturity fears.). The DT subscale was used for this outcome. Respondents rate each item as usually , often, sometimes, rarely or never. Subscale scores are computed by summing all item scores for each subscale. There are 7 items in the DT subscale (questions 1,7,11,16,25,32 and 49). the subscale score range is 0-21. The EDI-2 was completed by subjects at baseline and then monthly during study participation (range 0 -18 weeks). Change in the DT subscale score was calculated using an estimate of change in score between week 0 and week 7 derived from the mixed effect model across all time points."|month|||units on a scale||Standard Deviation|Mean
709951|NCT00146328|Secondary|Change From Baseline in CD4 Cell Count (LOCF)|Change from baseline in CD4 cell count with last observation carried forward(LOCF).|Baseline to 192-240 week time interval|FAS17 with last observation carried forward (LOCF, missing were replaced by the previous non-missing value), Group 1: TPV/r patients from Trials 1182.2, 1182.4,1182.6, 1182.52, 1182.12 and 1182.48; Group 2: Patients from 1182.51; Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed.||cells/mm3||Standard Deviation|Mean
709952|NCT00146328|Secondary|Change From Baseline in Human Immunodeficiency Virus-Ribonucleic Acid (HIV-RNA) Viral Load - Last Observation Carried Forward (LOCF)|Change from baseline in Human Immunodeficiency Virus-Ribonucleic Acid (HIV-RNA) viral load with last observation carried forward (LOCF)|Baseline to 192-240 week time interval|FAS17 with last observation carried forward (LOCF, missing were replaced by the previous non-missing value), Group 1: TPV/r patients from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48; Group 2: Patients from 1182.51; Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and rolled into 1182.17||Log 10 copies/mL||Inter-Quartile Range|Median
709953|NCT00146328|Primary|Number of Patients With Adverse Events Leading to Death|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17||participants|||Number
709954|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 -Low-density Lipoprotein (LDL)|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17||participants|||Number
709955|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Albumin|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.||participants|||Number
709956|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Uric Acid|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17||participants|||Number
709957|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Triglycerides|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17||participants|||Number
709958|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Bilirubin, Total|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17||participants|||Number
709960|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Cholesterol, Total|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17||participants|||Number
709961|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Glucose|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17||participants|||Number
709962|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Lipase|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.||participants|||Number
709963|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Creatine Phosphokinase|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.||participants|||Number
709964|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Amylase|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.||participants|||Number
709965|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Alkaline Phosphatase|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.||participants|||Number
709966|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Alanine Aminotransferase (ALT/GPT,SGPT)|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.||participants|||Number
709967|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Aspartate Aminotransferase (AST/GOT,SGOT)|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.||participants|||Number
709968|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Carbon Dioxide|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.||participants|||Number
709969|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Phosphate|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.||participants|||Number
709970|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Calcium|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.||participants|||Number
709971|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Potassium|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.||participants|||Number
709972|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Sodium|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.||participants|||Number
709973|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Prothrombin Time|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.||participants|||Number
709974|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Platelets|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.||participants|||Number
709975|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - White Blood Cell ct.|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.||participants|||Number
709976|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Haemoglobin|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.||participants|||Number
709977|NCT00152516|Secondary|Bayley Scale of Infant Development (BSID) II Psychomotor Development Index Scores Classification Shift From Baseline at Visit 7 (Week 48) (1 Month to < 4 Year Old)|This score is obtained from a total raw score which is the sum of a battery of individual questions. It is adjusted for a child's age, has an expected mean of 100 and standard deviation of 15, and can be categorized as: (1) Accelerated Performance (>= 115), (2) Within Normal Limits (85-114), (3) Mildly Delayed Performance (70-84), and (4) Significantly Delayed Performance (<=69). Changes from baseline are then further categorized where ‘Improved’ is any positive category change, ‘Stable’ is no category change, and ‘Worsened’ is any negative category change, from baseline.|Visit 7 (week 48)|The Bayley Scale of Infant Development (BSID) II assessment was performed only at selected sites where a neuropsychologist was available. Both a valid baseline and Visit 7 (week 48) assessment had to be present.||Number of subjects|||Number
709978|NCT00152516|Secondary|Bayley Scale of Infant Development (BSID) II Psychomotor Development Index Scores Classification Shift From Baseline at Visit 5 (Week 24) (1 Month to < 4 Year Old)|This score is obtained from a total raw score which is the sum of a battery of individual questions. It is adjusted for a child's age, has an expected mean of 100 and standard deviation of 15, and can be categorized as: (1) Accelerated Performance (>= 115), (2) Within Normal Limits (85-114), (3) Mildly Delayed Performance (70-84), and (4) Significantly Delayed Performance (<=69). Changes from baseline are then further categorized where ‘Improved’ is any positive category change, ‘Stable’ is no category change, and ‘Worsened’ is any negative category change, from baseline.|Visit 5 (week 24)|The Bayley Scale of Infant Development (BSID) II assessment was performed only at selected sites where a neuropsychologist was available. Both a valid baseline and Visit 5 (week 24) assessment had to be present.||Number of subjects|||Number
709979|NCT00152516|Secondary|Bayley Scale of Infant Development (BSID) II Mental Development Index Scores Classification Shift From Baseline at Visit 7 (Week 48) (1 Month to < 4 Year Olds)|This score is obtained from a total raw score which is the sum of a battery of individual questions. It is adjusted for a child's age, has an expected mean of 100 and standard deviation of 15, and can be categorized as: (1) Accelerated Performance (>= 115), (2) Within Normal Limits (85-114), (3) Mildly Delayed Performance (70-84), and (4) Significantly Delayed Performance (<=69). Changes from baseline are then further categorized where ‘Improved’ is any positive category change, ‘Stable’ is no category change, and ‘Worsened’ is any negative category change, from baseline.|Visit 7 (week 48)|The Bayley Scale of Infant Development (BSID) II assessment was performed only at selected sites where a neuropsychologist was available. Both a valid baseline and Visit 7 (week 48) assessment had to be present.||Number of subjects|||Number
709980|NCT00152516|Secondary|Bayley Scale of Infant Development (BSID) II Mental Development Index Scores Classification Shift From Baseline at Visit 5 (Week 24) (1 Month to < 4 Year Olds)|This score is obtained from a total raw score which is the sum of a battery of individual questions. It is adjusted for a child's age, has an expected mean of 100 and standard deviation of 15, and can be categorized as: (1) Accelerated Performance (>= 115), (2) Within Normal Limits (85-114), (3) Mildly Delayed Performance (70-84), and (4) Significantly Delayed Performance (<=69). Changes from baseline are then further categorized where ‘Improved’ is any positive category change, ‘Stable’ is no category change, and ‘Worsened’ is any negative category change, from baseline.|Visit 5 (Week 24)|The Bayley Scale of Infant Development (BSID) II assessment was performed only at selected sites where a neuropsychologist was available. Both a valid baseline and Visit 5 (week 24) assessment had to be present.||Number of subjects|||Number
709981|NCT00152516|Secondary|Leiter-R Associated Memory (AM) Memory Screen Composite Score Change From Baseline to Visit 5 (Week 24) and Visit 7 (Week 48) (4 to 16 Year Olds)|The Leiter-R AM battery has 10 subtests. The raw scores of the subtests are converted into scaled scores. Six composite scores are constructed from the 10 subtest scaled scores. The Memory Screen is one of them. It is composed of 2 subtests the Associated Pairs and Forward Memory. The sum of the Associated Pairs and Forward Memory subtest scaled scores are converted into a Memory composite score normally distributed with a mean and standard deviation of 100 (±15). Higher scores and positive changes from baseline are better. The range of the Memory Screen composite score is 44 to 155.|Baseline to Visit 5 (Week 24) and Visit 7 (Week 48)|At baseline there were 98 subjects with valid Memory Screen composite scores (mean=85.5, standard deviation=18.7). Of these 98 subjects, 87 had valid scores at Visit 5 (week 24) and 80 at Visit 7 (week 48).||Score on a scale||Standard Deviation|Mean
709982|NCT00152516|Secondary|Subject (>=8 Years Old) Global Evaluation Scale|There are 7 categories, 3 for improvement (Marked improvement, Moderate improvement, Slight improvement), 3 for worsening (Slight worsening, Moderate worsening, Marked worsening), and 1 for no change (No change).|End of Evaluation period (week 48 or at point of early discontinuation)|Intention to Treat (ITT) subjects >= 8 years old for whom the assessment was performed||Percentage of Participants|||Number
709983|NCT00152516|Secondary|Parent/Guardian Global Evaluation Scale|There are 7 categories, 3 for improvement (Marked improvement, Moderate improvement, Slight improvement), 3 for worsening (Slight worsening, Moderate worsening, Marked worsening), and 1 for no change (No change).|End of Evaluation period (week 48 or at point of early discontinuation)|Intention to Treat (ITT) subjects for whom the assessment was performed||Percentage of Participants|||Number
709984|NCT00152516|Secondary|Investigator Global Evaluation Scale|There are 7 categories, 3 for improvement (Marked improvement, Moderate improvement, Slight improvement), 3 for worsening (Slight worsening, Moderate worsening, Marked worsening), and 1 for no change (No change).|End of Evaluation period (week 48 or at point of early discontinuation)|Intention to Treat (ITT) subjects for whom the assessment was performed||Percentage of Participants|||Number
709985|NCT00152516|Secondary|Percent of Subjects With Each Seizure Type During the Evaluation Period|"Type I Seizure is a partial onset Seizure (see International League Against Epilepsy definitions).
Type II Seizure is a Generalized Seizure (see International League Against Epilepsy definitions).
Type III Seizure is a Unknown Seizure Type (see International League Against Epilepsy definitions).
A subject could experience more than one seizure type."|Evaluation period (48 weeks)|255 subjects were Intention to Treat (ITT), i.e. all subjects with at least 1 dose of study medication. Of these 255 ITT subjects 1 was missing treatment period seizure data.||Percentage of Participants|||Number
709986|NCT00152516|Secondary|Total Seizure (Type I, II, III) Continuously Seizure Free During the Maintenance Period|"The measure description is the product limit adjusted percent of subjects seizure free starting from the beginning of the Maintenance Period.
The up-titration period is the up to 6 week period of increasing dose prior to the Maintenance Period. The Maintenance Period is the period of stable dosing, subsquent to the up-titration period, which could last from 42 to 48 weeks."|greater than or equal to 24 weeks, greater than or equal to 40 weeks|255 subjects were Intention to Treat (ITT), i.e. all subjects with at least 1 dose of study medication. Of these 255 ITT subjects 1 was missing treatment period seizure data leaving a sample size of 254. Of these 254 subjects 233 continued into the maintenance period.||Percentage of Participants|||Number
709987|NCT00152516|Secondary|Total Seizure (Type I, II, III) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)|For subjects with greater than 24 weeks in the evaluation phase the denominator for each subject is their number of days in the evaluation phase.|Subjects with greater than 24 weeks of exposure|Intention to Treat (ITT) subjects with > 24 weeks of exposure and treatment period seizure data||Percentage of Days||Inter-Quartile Range|Median
709988|NCT00152516|Secondary|Total Seizure (Type I, II, III) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)|For subjects with up to 24 weeks in the evaluation phase the denominator for each subject is their number of days in the evaluation phase.|Subjects with up to 24 weeks of exposure|Intention to Treat (ITT) Subjects with <= 24 Weeks of Exposure and treatment period seizure data||Percentage of Days||Inter-Quartile Range|Median
709989|NCT00152516|Secondary|Partial Seizure (Type I) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)|For subjects with greater than 24 weeks in the evaluation phase the denominator for each subject is their number of days in the evaluation phase.|Subjects with greater than 24 weeks of exposure|Intention to Treat (ITT) Subjects with > 24 Weeks of Exposure and treatment period seizure data||Percentage of days||Inter-Quartile Range|Median
709990|NCT00152516|Secondary|Partial Seizure (Type I) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)|For subjects with up to 24 weeks in the evaluation phase the denominator for each subject is their number of days in the evaluation phase.|Subjects with up to 24 weeks of exposure|Intention to Treat (ITT) subjects with <= 24 Weeks of Exposure and treatment period seizure data||Percentage of Days||Inter-Quartile Range|Median
709991|NCT00152516|Secondary|Partial Seizure (Type I) Responder Rate (Percent) During the Up-titration/Conversion Phase and by Visit During the Maintenance Phase|"The responder rate is defined as the number of responders. A responder is a patient with a 50% or greater change (reduction) in partial seizure frequency per week.
Note: Rates were reported as percentages."|Up-titration (4 weeks); Maintenance Visits 3-4 (weeks 4-14, 6-15, or 8-16); Visits 4-5 (weeks 14-24, 15-24, or 16-24); Visits 5-6 (weeks 24-36); Visits 6-7 (weeks 36-48)|255 subjects were Intention to Treat (ITT), i.e. all subjects with at least 1 dose of study medication. Of these 255 ITT subjects 4 were missing a baseline, 3 had a baseline of 0, and 1 was missing treatment period seizure data. The result was a sample size of 247. Of these 247 subjects 226 continued into the maintenance period.||Percentage of Participants|||Number
709992|NCT00152516|Secondary|Change (Reduction) From Baseline in Total (Type I, II, III) Seizure Frequency Per Week Over Time During Treatment Period|Positive changes from Baseline indicate an improvement (i.e., a reduction) in seizure frequency per week.|Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)|255 subjects were Intention to Treat (ITT), i.e. all subjects with at least 1 dose of study medication. Of these 255 ITT subjects 4 were missing a baseline and 1 was missing treatment period seizure data. The result was a sample size of 250. Of these 250 subjects 229 continued into the maintenance period.||Seizures Per Week||Inter-Quartile Range|Median
709993|NCT00152516|Secondary|Change (Reduction) From Baseline in Partial (Type I) Seizure Frequency Per Week Over Time During Treatment Period|Positive changes from Baseline indicate an improvement (i.e., a reduction) in seizure frequency per week.|Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)|255 subjects were Intention to Treat (ITT), i.e. all subjects with at least 1 dose of study medication. Of these 255 ITT subjects 4 were missing a baseline and 1 was missing treatment period seizure data. The result was a sample size of 250. Of these 250 subjects 229 continued into the maintenance period.||Seizures Per Week||Inter-Quartile Range|Median
710026|NCT00154102|Secondary|Safety - Number of Patients Experiencing Any Adverse Event|Please refer to Adverse Events section for further details|time from first dose up to 30 days after last dose of study treatment reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 30 Nov 2007|Safety Population||participants|||Number
709994|NCT00152516|Secondary|Total (Type I, II, III) Seizure Frequency Per Week Over Time During Treatment Period.||Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)|255 subjects were Intention to Treat (ITT), i.e. all subjects with at least 1 dose of study medication. Of these 255 ITT subjects 1 was missing treatment period seizure data leaving a sample size of 254. Of these 254 subjects 233 continued into the maintenance period.||Seizures Per Week||Inter-Quartile Range|Median
709995|NCT00152516|Secondary|Partial (Type I) Seizure Frequency Per Week Over Time During Treatment Period.||Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)|255 subjects were Intention to Treat (ITT), i.e. all subjects with at least 1 dose of study medication. Of these 255 ITT subjects 1 was missing treatment period seizure data leaving a sample size of 254. Of these 254 subjects 233 continued into the maintenance period.||Seizures Per Week||Inter-Quartile Range|Median
709996|NCT00152516|Secondary|Percentage Change (Reduction) of Total (Type I, II, III) Seizure Frequency Per Week From Baseline Over Time During Treatment Period.|Positive changes from Baseline indicate an improvement (i.e., a reduction) in seizure frequency per week.|Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)|255 subjects were Intention to Treat (ITT), i.e. all subjects with at least 1 dose of study medication. Of these 255 ITT subjects 4 were missing a baseline, 2 had a baseline of 0, and 1 was missing treatment period seizure data. The result was a sample size of 248. Of these 248 subjects 227 continued into the maintenance period.||Percent Reduction in Seizures per Week||Inter-Quartile Range|Median
709997|NCT00152516|Primary|Percentage Change (Reduction) of Partial (Type I) Seizure Frequency Per Week From Baseline Over Time During Treatment Period.|Positive changes from Baseline indicate an improvement (i.e., a reduction) in seizure frequency per week.|Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)|255 subjects were Intention to Treat (ITT), i.e. all subjects with at least 1 dose of study medication. Of these 255 ITT subjects 4 were missing a baseline, 3 had a baseline of 0, and 1 was missing treatment period seizure data. The result was a sample size of 247. Of these 247 subjects 226 continued into the maintenance period.||percent reduction in seizures Per Week||Inter-Quartile Range|Median
710000|NCT00153920|Secondary|Any Grade Neuropathic Pain Events|Any grade neuropathic pain events based on CTCAEv2 as reported on case report forms.|Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).|The analysis population is comprised of eligible and treated participants.||adverse events|||Number
710001|NCT00153920|Secondary|Any Grade Sensory Neuropathy Events|Any grade sensory neuropathy events based on CTCAEv3 as reported on case report forms.|Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).|The analysis population is comprised of eligible and treated participants.||adverse events|||Number
710002|NCT00153920|Secondary|Progression-Free Survival (PFS)|PFS based on the Kaplan-Meier method is defined as the time from study entry to the earliest documentation of disease progression (PD) or death. Participants alive without evidence of PD were censored at the earliest date of last disease assessment or date of initiation of non-protocol therapy. PD was established based European Group for Blood and Marrow Transplantation criteria (Blade J et al Br J Haematol 1998). PD required 1 or more of the following: >25% increase in serum monoclonal protein with absolute minimum of 0.5 g/dL (confirmed on repeat investigation); >25% increase in 24-hour urinary light chain excretion with minimum absolute increase of 200 mg/24 hrs (confirmed on repeat investigation); >25% increase in bone marrow plasma cells with minimum absolute increase of 10%; Definite increase in size of existing soft tissue plasmacytomas and/or lytic lesions or new; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL not attributable to other cause).|Disease was assessed every two cycles on treatment and every 6 weeks in long-term follow-up. Median follow-up was 29 months as of the data analysis.|The analysis population is comprised of eligible and treated participants.||months||95% Confidence Interval|Median
710003|NCT00153920|Secondary|Time to Progression (TTP)|TTP based on the Kaplan-Meier method is defined as the time from start of treatment to documentation of disease progression (PD). Participants without evidence of PD were censored at the latest date of last disease assessment or date of initiation of non-protocol therapy. PD was established based European Group for Blood and Marrow Transplantation criteria (Blade J et al Br J Haematol 1998). PD required 1 or more of the following: >25% increase in serum monoclonal protein with absolute minimum of 0.5 g/dL (confirmed on repeat investigation); >25% increase in 24-hour urinary light chain excretion with minimum absolute increase of 200 mg/24 hrs (confirmed on repeat investigation); >25% increase in bone marrow plasma cells with minimum absolute increase of 10%; Definite increase in size of existing or new soft tissue plasmacytomas and/or lytic lesions; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL not attributable to other cause).|Disease was assessed every two cycles on treatment and every 6 weeks in long-term follow-up. Median follow-up was 29 months.|The analysis population is comprised of eligible and treated participants.||months||95% Confidence Interval|Median
710004|NCT00153920|Secondary|Very Good Partial Response (VGPR) Rate|Very good partial response or better was defined per International Uniform Response criteria (Durie B, Harousseau JL, Miquel JS, et al Leukemia 2006). See CR requirements in primary outcome measure plus if serum and urine M protein were unmeasurable then immunoglobulin free light chain (FLC) must be in a normal ratio of 0.26-1.65 at two consecutive times. VGPR required the following: Serum and urine M-component detectable by immunofixation but not on electrophoresis; >=90% reduction in serum M-component plus urine M-component <100 mg per 24 hours (by SPEP and UPEP); if the serum and urine M protein were unmeasurable then a >90% decrease in the difference between involved and uninvolved FLC levels.|Response was assessed every two cycles on treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).|The analysis population is comprised of eligible and treated participants.||proportion of participants||95% Confidence Interval|Number
710005|NCT00153920|Primary|Objective Response (OR) Rate|Objective response was defined as complete response (CR) or partial response (PR) according to European Group for Blood and Marrow Transplantation criteria (Blade J et al Br J Haematol 1998). CR required all of the following: Negative immunofixation on the serum and urine at two consecutive times for minimum 6 weeks; Disappearance of soft tissue plasmacytomas for at least 6 weeks; <5% plasma cells in bone marrow on 2 determinations for a minimum of 6 weeks; No increase in the size or number of lytic bone lesions. PR required all the following: ≥50% reduction in the level of the serum monoclonal protein on 2 determinations for minimum 6 weeks; If present, reduction in 24-hour urinary light chain excretion either by ≥90% or to <200 mg on 2 determinations for minimum 6 weeks; ≥50% reduction size of soft tissue plasmacytomas for minimum 6 weeks; No increase in the number or size of lytic bone lesions. Development of a compression fracture does not exclude response in either category.|Response was assessed every two cycles on treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).|The analysis population is comprised of eligible and treated participants.||proportion of participants||95% Confidence Interval|Number
710006|NCT00153985|Secondary|The Incidence of Grade II-IV Acute Graft vs. Host Disease.|Outcome was measured by incidence and severity of acute and chronic GVHD following donor stem cell infusion.|3 years|All patients enrolled.||participants|||Number
710007|NCT00153985|Secondary|Solid Organ Toxicity Related to the Conditioning Regimen.|Outcome was measured by the assessment of organ toxicity related to Busulfex, fludarabine and alemtuzumab.|3 years|All patients enrolled.||participants|||Number
710008|NCT00153985|Primary|Stable Engraftment With Donor Stem Cells in Patients With Severe Hemoglobinopathy.|Outcome was measured by ANC >500 for three consecutive days prior to day 30 after PBSC infusion, >25% of hematopoietic cells are donor derived as determined by molecular chimerism assays or cytogenetic methods prior to day 45 after PBSC infusion and >25% of hematopoietic cells are donor derived as determined by molecular chimerism assays or cytogenetic methods after day 180 after PBSC infusion.|3 years|All patients enrolled.||participants|||Number
710009|NCT00154063|Secondary|Percentage of Participants With a Greater Than or Equal to 50% Decrease in Migraine Period Frequency Per 28 Days in Treatment Phase (LOCF)|A migraine period was defined as a migraine headache that started, ended, or recurred within 24 hours. If the headache persisted for longer than 24 hours, it was considered a new migraine period. Participants recorded the frequency of migraine period in diary. Efficacy analyses were performed using both the 24-hour and 48-hour rule for defining migraine periods. The data is presented as percentage of participants.|Week 5 to Week 19|ITT Population||Percentage of Participants|||Number
710010|NCT00154063|Secondary|Percentage of Participants With a Greater Than or Equal to 50% Decrease in Migraine Attack Frequency Per 28 Days in Treatment Phase (LOCF)|Qualified migraine headache was defined as two major subtypes: migraine without aura(headache that lasted 4-72 hours with at least two characteristics: unilateral location, pulsating quality, moderate/ severe pain intensity or aggravation by/ causing avoidance of routine physical activity and either nausea/ vomiting or photophobia,phonophobia); migraine with aura (attack with reversible focal neurological symptoms that usually precede or sometimes accompany the headache) per Migraine Criteria of the Headache Classification Committee of the International Headache Society. All of the qualified headaches, which occur after the initial qualified migraine headache, but within 24 hours of previous qualified migraine headache, were collapsed into one qualified migraine attack. Two qualified migraine attacks were considered to be distinct when the end of previous and the beginning of the next migraine attack were separated by at least 24/48 hours per 24/48 hour rule.|Week 5 to Week 19|ITT Population||Percentage of Participants|||Number
710011|NCT00154063|Secondary|Change From Baseline of Migraine Disability Assessment Questionnaire Score (MIDAS) at Week 23: Missed Work or School|The MIDAS questionnaire was a participant assessed 7-item questionnaire designed to measure the impact of headache in the last 3 months. Based on question 1 , the number of missed work or school because of a headache was assessed. The data is presented as mean days +/- standard deviation.|Baseline, Week 23|ITT Population. Only patients with non-missing baseline data are summarized.||Days||Standard Deviation|Mean
710012|NCT00154063|Secondary|Change From Baseline of Migraine Disability Assessment Questionnaire Score (MIDAS) at Week 23: Missed Non-Work Activities|The MIDAS questionnaire was a participant assessed 7-item questionnaire designed to measure the impact of headache in the last 3 months. Based on question 5, the number of days when participant miss leisure or social activities because of a headache was assessed. The data is presented as mean days +/- standard deviation.|Baseline, Week 23|ITT Population. Only patients with non-missing baseline data are summarized.||Days||Standard Deviation|Mean
710013|NCT00154063|Secondary|Change From Baseline of Migraine Disability Assessment Questionnaire Score (MIDAS) at Week 23: Missed Housework|The MIDAS questionnaire was a participant assessed 7-item questionnaire designed to measure the impact of headache in the last 3 months. Based on question 3, the number of days when participant skipped performing household chores or regular household activities because of a headache was assessed. The data is presented as mean days +/- standard deviation.|Baseline, Week 23|ITT Population. Only patients with non-missing baseline data are summarized.||Days||Standard Deviation|Mean
710014|NCT00154063|Secondary|Change From Baseline of Migraine Disability Assessment Questionnaire Score (MIDAS) at Week 23: Less Work or School|The MIDAS questionnaire was a participant assessed 7-item questionnaire designed to measure the impact of headache in the last 3 months. Based on question 2, the number of days with reduced productivity by at least half at school or work because of a headache was assessed. The data is presented as mean days +/- standard deviation.|Baseline, Week 23|ITT Population. Only patients with non-missing baseline data are summarized.||Days||Standard Deviation|Mean
710015|NCT00154063|Secondary|Change From Baseline of Migraine Disability Assessment Questionnaire Score (MIDAS) at Week 23: Less Housework|The MIDAS questionnaire was a participant assessed 7-item questionnaire designed to measure the impact of headache in the last 3 months. Based on question 4, the number of days when productivity in household work reduced by half of more because of a headache was assessed. The data is presented as mean days +/- standard deviation.|Baseline, Week 23|ITT Population. Only patients with non-missing baseline data are summarized.||Days||Standard Deviation|Mean
710081|NCT00149825|Secondary|Remission of Insomnia|Percent of participants in insomnia remission. Remission of insomnia was defined by an Insomnia Severity Index (ISI)score < 8. The ISI (Insomnia Severity index) scores range between 0 and 38. A score < 8 indicates absence of insomnia.|After 12 weeks or at the last available time point|Included in the analysis were all participants who attended at least one post randomization visit.||percent|||Number
710016|NCT00154063|Secondary|Change From Baseline of Migraine Disability Assessment Questionnaire Score (MIDAS) at Week 23: Headaches|The MIDAS questionnaire was a participant assessed 7-item questionnaire designed to measure the impact of headache in the last 3 months. Based on question 6, the number of days with headache (Headache which lasted more than one day was counted as each day) was assessed. The data is presented as mean days +/- standard deviation.|Baseline, Week 23|ITT Population. Only patients with non-missing baseline data are summarized.||Days||Standard Deviation|Mean
710017|NCT00154063|Secondary|Change From Baseline of Migraine Disability Assessment Questionnaire Score (MIDAS) at Week 23: Headache Pain Score|The MIDAS questionnaire was a participant assessed 7-item questionnaire designed to measure the impact of headache in the last 3 months. Based on question 7, pain due to headache was assessed on a scale of 0-10 with 0 being no pain and 10 being the most painful.|Baseline, Week 23|ITT Population. Only patients with non-missing baseline data are summarized.||units on a scale||Standard Deviation|Mean
710018|NCT00154063|Secondary|Change From Baseline in Number of Participants With Patient Global Impression of Change (PGIC) of Migraine (LOCF)|"The PGIC was a self-evaluation scale for each patient to assess his or her status compared to baseline in migraine headache frequency and intensity, the occurrence of adverse events, and overall functional status, measured on a 7-point scale. The scale ranges from very much improved with a score of 1 to very much worse with a score of 7. A responder is defined as being very much improved or much improved. The data is presented as number of participants. LOCF = last observation carried forward (ie, observation from last phase with active treatment)"|Baseline to Week 23|ITT Population||Participants|||Number
710019|NCT00154063|Secondary|Change From Baseline in Number of Days With Migraine Attack Per 28 Days in Treatment Phase (LOCF)|A migraine attack day was defined as a calendar day (from 0 hours to 24 hours) during which at least one migraine attack took place. If the migraine attack continues through midnight, each day will be counted separately. Efficacy analyses were performed using both the 24-hour and 48-hour rule. Data is presented as mean number of days with migraine attack per 28 days +/- standard error.|Baseline to Week 19|ITT Population||Days||Standard Error|Mean
710020|NCT00154063|Secondary|Change From Baseline in Number of Days Requiring Symptomatic Rescue Medication Per 28 Days in Treatment Phase (LOCF)|The number of days requiring symptomatic rescue medication was calculated as the number of calender days during the migraine attack when the patient took one or more migraine rescue medications as recorded on the participant's diary. The calendar date(s) during which medication was taken will be used for calculations. Efficacy analyses were performed using both the 24-hour and 48-hour rule. The data is presented as mean days +/- standard error.|Baseline to Week 19|ITT Population||Days||Standard Error|Mean
710021|NCT00154063|Primary|Change From Baseline in Migraine Period Frequency Per 28 Days in Treatment Phase (LOCF)|A migraine period was defined as a migraine headache that started, ended, or recurred within 24 hours. If the headache persisted for longer than 24 hours, it was considered a new migraine period. Participants recorded the frequency of migraine period in diary. Efficacy analyses were performed using both the 24-hour and 48-hour rule for defining migraine periods. Data is presented as mean number of migraine period per 28 days +/- standard error. A negative change indicates a decrease in the number of migraine periods from baseline. LOCF = last observation carried forward (ie, observation from last phase with active treatment)|Baseline to Week 19|The efficacy analysis was performed on the Intention to treat (ITT) Population, which was defined as all randomized subjects who received at least 1 dose of double-blind study medication, and had baseline and postbaseline migraine assessments in at least 1 phase.||Migraine period||Standard Error|Mean
710022|NCT00154063|Secondary|Change From Baseline in Migraine Period Frequency Per 28 Days in Maintenance Phase|A migraine period was defined as a migraine headache that started, ended, or recurred within 24 hours. If the headache persisted for longer than 24 hours, it was considered a new migraine period. Efficacy analyses were performed using both the 24-hour and 48-hour rule for defining migraine periods. Data is presented as mean number of migraine period per 28 days +/- standard error. A negative change indicates a decrease in the number of migraine periods from baseline.|Baseline, Week 11 to Week 19|ITT Population||Migraine period||Standard Error|Mean
710023|NCT00154063|Secondary|Change From Baseline in Migraine Attack Frequency Per 28 Days in Treatment Phase (LOCF)|Qualified migraine headache was defined as two major subtypes: migraine without aura(headache that lasted 4-72 hours with at least two characteristics: unilateral location, pulsating quality, moderate/ severe pain intensity or aggravation by/ causing avoidance of routine physical activity and either nausea/ vomiting or photophobia,phonophobia); migraine with aura (attack with reversible focal neurological symptoms that usually precede or sometimes accompany the headache) per Migraine Criteria of the Headache Classification Committee of the International Headache Society. All of the qualified headaches, which occur after the initial qualified migraine headache, but within 24 hours of previous qualified migraine headache, were collapsed into one qualified migraine attack. Two qualified migraine attacks were considered to be distinct when the end of previous and the beginning of the next migraine attack were separated by at least 24/48 hours per 24/48 hour rule.|Baseline to Week 19|ITT Population||Migraine attack||Standard Error|Mean
710024|NCT00154063|Secondary|Change From Baseline in Average Migraine Severity Per Migraine Attack in Treatment Phase (LOCF)|The average migraine attack severity in each treatment phase was calculated using the sum of the severity of migraine attacks during the treatment phase, divided by the number of qualified migraine attacks. The scale of severity for each migraine attack ranges from 0 to 100, with higher scores indicating increased migraine severity. Efficacy analyses were performed using both the 24-hour and 48-hour rule.|Baseline to Week 19|ITT Population||Units on a Scale||Standard Error|Mean
710025|NCT00154063|Secondary|Change From Baseline in Average Duration Per Migraine Attack in Treatment Phase (LOCF)|The duration of a migraine attack was the sum of the duration (in hours) of each migraine headache that was collapsed to form the migraine attack. The time between the offset of first migraine headache and the onset of the next migraine headache was not counted in the duration of migraine attack. The average duration of the migraine attacks in each phase was calculated as the total duration (in hours) of the migraine attacks during each phase, divided by the number of migraine attacks in the corresponding treatment phase. Efficacy analyses were performed using both the 24-hour and 48-hour rule. The data is presented as mean hours +/- standard error.|Baseline to Week 19|ITT Population||Hours||Standard Error|Mean
711279|NCT00176852|Secondary|Determine the Concentration of Campath in the Serum||Day 0|The Principal Investigator removed this as a study objective and therefore Campath concentrations were not collected.|||||
710027|NCT00154102|Secondary|Quality of Life Assessment (EORTC QLQ-C30) Social Functioning|Mean social functioning scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a higher level of functioning.|at baseline, at week 8, at week 16, at week 24, at week 32, and at week 40, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006|1125 subjects (566 in the Cetuximab + FOLFIRI arm and 559 in the FOLFIRI alone arm) completed at least one evaluable QLQ-C30 questionnaire and were thus included in the Evaluable for QLQ-C30 population||scores on a scale||Standard Error|Least Squares Mean
710028|NCT00154102|Secondary|Quality of Life (QOL) Assessment European Organisation for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status|Mean global health status scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a better QoL.|at baseline, at week 8, at week 16, at week 24, at week 32, and at week 40, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006|1125 subjects (566 Cetuximab + FOLFIRI; 559 FOLFIRI alone) completed at least 1 evaluable questionnaire & were included in the Evaluable for QLQ-C30 population. Numbers at each timepoint were (Cetuximab + FOLFORI/FOLFORI alone, respectively): baseline 430/423; Week 8 421/390; Week 16 312/309; Week 24 255/244; Week 32 164/154; Week 40 122/96||scores on a scale||Standard Error|Least Squares Mean
710029|NCT00154102|Secondary|Participants With No Residual Tumor After Metastatic Surgery|Participants with no residual tumor after on-study surgery for metastases|time from first dose up to 30 days after last dose of study treatment reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 30 Nov 2007|ITT population (allocation to treatment groups as randomized and treated)||Participants|||Number
710030|NCT00154102|Secondary|Duration of Response - Independent Review Committee (IRC) Assessments|"Time from first assessment of Complete Response or Partial Response to disease progression or death (within 60 days of last tumor assessment).
Patients without event are censored on the date of last tumor assessment. Tumor assessments based on modified WHO criteria."|Time from first assessment of complete response or partial response to disease progression, death or last tumor assessment reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006|ITT population (allocation to treatment groups as randomized and treated)||months||95% Confidence Interval|Median
710031|NCT00154102|Secondary|Disease Control Rate - Independent Review Committee (IRC) Assessments|The disease control rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response + Stable Disease as best overall response according to radiological assessments (based on modified WHO criteria).|Evaluations were performed every 6 weeks until progression reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006|ITT population (allocation to treatment groups as randomized and treated)||percentage of participants||95% Confidence Interval|Number
710032|NCT00154102|Secondary|Best Overall Response Rate (KRAS Mutant Population) - Independent Review Committee (IRC) Assessments|The best overall response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified WHO criteria).|evaluations were performed every 6 weeks until progression reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006|Intent to Treat (ITT) population with KRAS Mutant tumor status as collected until 28 August 2009||percentage of participants||95% Confidence Interval|Number
710033|NCT00154102|Secondary|Best Overall Response Rate (KRAS Wild-Type Population) - Independent Review Committee (IRC) Assessments|The best overall response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified WHO criteria).|evaluations were performed every 6 weeks until progression reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006|Intent to Treat (ITT) population with KRAS Wild Type tumor status as collected until 28 August 2009||percentage participants||95% Confidence Interval|Number
710034|NCT00154102|Secondary|Best Overall Response Rate - Independent Review Committee (IRC) Assessments|The best overall response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified WHO criteria).|evaluations were performed every 6 weeks until progression reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006|ITT population (allocation to treatment groups as randomized and treated)||percentage of participants||95% Confidence Interval|Number
710035|NCT00154102|Secondary|Overall Survival Time (KRAS Mutant Population)|Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whichever is later.|Time from randomisation to death or last day known to be alive reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 31 May 2009|Intent to Treat (ITT) population with KRAS Mutant tumor status as collected until 28 August 2009||months||95% Confidence Interval|Median
710036|NCT00154102|Secondary|Overall Survival Time (KRAS Wild-Type Population)|Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whichever is later.|Time from randomisation to death or last day known to be alive reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 31 May 2009|Intent to Treat (ITT) population with KRAS Wild Type tumor status as collected until 28 August 2009||months||95% Confidence Interval|Median
710037|NCT00154102|Secondary|Overall Survival Time (OS)|Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whichever is later.|Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 31 May 2009|ITT population (allocation to treatment groups as randomized and treated)||months||95% Confidence Interval|Median
710083|NCT00149890|Secondary|Percentage of Participants With Treatment Failure Within Three and Six Months|To evaluate the proportion of patients with treatment failure treated with a therapy consisting of intraoperative versus without intraoperative steroids in combination with basiliximab, cyclosporine/cyclosporine microemulsion and steroids within three and six months.|3 and 6 months|Intention to treat population||Percentage of participants||95% Confidence Interval|Number
710038|NCT00154102|Primary|Progression-free Survival Time (KRAS Mutant Population) - Independent Review Committee (IRC) Assessments|"Duration from randomization until radiological progression (based on modified WHO criteria) or death due to any cause.
Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment."|Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006|Intent to Treat (ITT) population with KRAS Mutant tumor status as collected until 28 August 2009||months||95% Confidence Interval|Median
710039|NCT00154102|Primary|Progression-free Survival Time (Chinese V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Wild-Type Population) - Independent Review Committee (IRC) Assessments|"Duration from randomization until radiological progression (based on modified WHO criteria) or death due to any cause.
Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment."|Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006|Intent to Treat (ITT) population with KRAS Wild Type tumor status as collected until 28 August 2009||months||95% Confidence Interval|Median
710040|NCT00154102|Primary|Progression-free Survival (PFS) Time - Independent Review Committee (IRC) Assessments|"Duration from randomization until radiological progression (based on modified World Health Organisation (WHO) criteria) or death due to any cause.
Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment."|Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006|Primary analysis on Intent to Treat (ITT) population i.e. all randomized subjects who have received at least one dose of randomized treatment (allocation to treatment groups as randomized).||months||95% Confidence Interval|Median
710041|NCT00154284|Secondary|Safety Based on Adverse Event (AE) Reporting||12 month||||||
710042|NCT00154284|Secondary|Calculated Creatinine Clearance at 6 Month and 12 Month|"Creatinine clearance calculated by Cockcroft-Gault formula and summarized by mean, and standard deviation. Cockcroft-Gault formula to calculate Creatinine Clearance (CrCl[mL/min]) is shown below:
CrCl[mL/min] = (140 – A) * W / (72 * C) * R. Where A is age at sample date [years], W is body weight at specific visit [kg], C is the serum concentration of creatinine [mg/dL], R = 1 if the patient is male and = 0.85 if female."|6 month and 12 months|Intention to treat (ITT) population.||mL/min||Standard Deviation|Mean
710043|NCT00154284|Secondary|Serum Creatinine at Month 6 and 12|serum creatinine summarized by mean and standard deviation|6 month and 12 months|Intention to treat (ITT) population.||µmol/L||Standard Deviation|Mean
710044|NCT00154284|Secondary|Number of Participants With Biopsy-proven Acute Rejection (BPAR) Episodes, Graft Loss, Death or Loss to Follow-up|Renal biopsies were collected for all cases of suspected acute rejection. For these cases, regardless of initiation of anti-rejection treatment, a graft core biopsy had been performed within 48 hours. These biopsies were listed on the Kidney Allograft Biopsy eCRF and the results used for patient management for BPAR. Graft loss was defined as the allograft was presumed to be lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis as well as re-transplant. BPAR, graft loss, death, or loss to follow-up was analyzed by means of frequency tables.|Month 12|Intention to treat (ITT) population.||Participants|||Number
710045|NCT00154284|Primary|Renal Function Measured by Calculated Glomerular Filtration Rate (GFR Calculated According to the Nankivell Formula)|"Nankivell’s formula for calculated GFR is shown below:
GFR [mL/min] = 6.7/C + W/4 – UREA/2 – 100/H2+ 35 (25 for females). Where W is body weight at specific visit [kg], H is height at specific visit [m], C is the serum concentration of creatinine [mmol/L], and UREA is the serum concentration of urea [mmol/L]. UREA was calculated from blood urea nitrogen (BUN) lab data by: UREA = 2.1441*BUN. If a GFR value from Nankivell formula was less than 10 [mL/min], then the value was assigned as 10 [mL/min]."|At Month 3 and Month 12|Intention to treat (ITT) population.||mL/min per 1.73 m^2||Standard Deviation|Mean
710046|NCT00154297|Secondary|Number of Participants With Any Wound Healing Disorder During the 12-month Treatment Period|A wound was considered healed if all the suture material and staples were removed and the wound was intact by 3 weeks. Any wound opened beyond this point, infected, drained fluid or herniated was considered not healed.|Month 12|Intention to treat (ITT) population.||Participants|||Number
710047|NCT00154297|Secondary|Duration of Dialysis|The mean duration in days of any dialysis session that occurred within the 12 month treatment period.|12 months|The number of patients analyzed includes those with any dialysis in the 12 month period||Days||Standard Deviation|Mean
710048|NCT00154297|Secondary|Number of Participants Who Underwent Any Dialysis Within the 12-month Treatment Period|The number of patients who underwent any dialysis within the 12-month treatment period.|Month 12|Intention to treat (ITT) population.||Participants|||Number
710049|NCT00154297|Secondary|Number of Participants Considered in Failure for the Primary Failure Endpoint at 12 Months Post-transplantation.|"The primary efficacy variable was the “primary failure endpoint” at 12 months defined as the occurrence of one or more of the following events within the first 12 months:
delayed graft function (DGF), defined as the need for dialysis within the first 7 days post-transplantation excluding the first day post-transplantation
efficacy failure (biopsy proven acute rejection (BPAR), graft loss, death or loss to follow-up)
wound healing disorder related to initial transplant surgery"|at 12 Month post-transplantation|Intention to treat (ITT) population.||Participants|||Number
710050|NCT00154297|Secondary|Number of Participants Considered in Failure for the Primary Failure Endpoint at 6 Months Post-transplantation.|"The primary efficacy variable was the “primary failure endpoint” at 6 months defined as the occurrence of one or more of the following events within the first 6 months:
delayed graft function (DGF), defined as the need for dialysis within the first 7 days post-transplantation excluding the first day post-transplantation
efficacy failure (biopsy proven acute rejection (BPAR), graft loss, death or loss to follow-up)
wound healing disorder related to initial transplant surgery"|at 6 Month post-transplantation|Intention to treat (ITT) population.||Participants|||Number
710100|NCT00156910|Primary|Change in Frequency of Headache Episodes|Mean change from baseline in frequency (number) of headache episodes during the 28 day period ending with Week 24. Headache episode defined as patient-reported headache with a start and stop time indicating that the pain lasted >= 4 continuous hours.|Baseline, Week 24|Intent to Treat||Headache Episodes||Standard Deviation|Mean
710051|NCT00154297|Primary|Number of Participants Considered in Failure for the Primary Failure Endpoint at 3 Months|“In Failure”, is at least one of these events occurred within the first 3 months: delayed graft function(DGF), (need for dialysis within the first 7 days,minus day one,post-transplantation); Biopsy proven acute rejection (BPAR), Graft loss, (allograft was presumed lost on the day the patient started and not removable from dialysis). Death; Loss to follow-up; Wound healing disorder(Any wound related to the kidney transplantation being opened beyond 3 weeks, or infected, or drained fluid or herniated was considered not healed).|Month 3|Intention to treat (ITT) population.||Participants|||Number
710052|NCT00154310|Secondary|Number of Participants Who Experienced an Adverse Event or Serious Adverse Event|Additional information about the number of participants who experienced Adverse Events (greater than 5%) or Serious Adverse Events can be found in the Adverse Event section.|Aes from end of core study period (month 12) to end of follow-up period (month 60)|Safety Population consisted of all participants in whom transplantation was performed and who were treated with at least one dose of any immunosuppressive medication.||Participants|||Number
710053|NCT00154310|Secondary|Changes in Cardiovascular Risk From Month 4.5 to Final Assessment at Month 12|An updated 1991 Framingham coronary prediction algorithm was used to estimate the total risk of developing coronary heart diseases (CHD) over the course of 10 years. Risk was calculated separately for male and females. To calculate risk, points were assigned for each of the following risk factors: age, levels of LDL cholesterol, HDL cholesterol, blood pressure, cigarette smoking, and diabetes mellitus. The sum of the individual risk factor points gives a total point score, which ranges from -5 to 18 for men and -16 to 24 for women. Higher points indicate a higher risk for CHD.|Month 4.5 and Month 12|Safety Population for whom data was available at Month 4.5 and end of treatment.||Points||Standard Deviation|Mean
710054|NCT00154310|Secondary|Number of Participants With Occurrence of Treatment Failures|Treatment failures defined as a composite endpoint of biopsy proven acute rejection, graft loss, death, loss to follow up and discontinuations due to lack of efficacy or toxicity, or conversion to another regimen (at least one condition must be present).|up to or at Month 12|Intention to treat (ITT) population (Randomized Patients).||Participants|||Number
710055|NCT00154310|Secondary|Number of Participants With Occurrence of Biopsy Proven Acute Rejection (BPAR), Graft Loss or Death|The number of participants with occurrence of biopsy proven acute rejection (BPAR), graft loss, or death up to Month 12 during the randomized treatment period. BPAR was defined as a biopsy graded IA, IB, IIA, IIB or III according to Banff 97 classification. A graft core biopsy was performed prior to 24 hours following initiation of graft rejection therapy. The allograft is presumed to be lost on the day the patient starts dialysis and was not able to subsequently be removed from dialysis. If the patient underwent a graft nephrectomy, then the day of nephrectomy was the day of graft loss.|Up to Month 12|Intent to Treat Population (Randomized Patients)||Participants|||Number
710056|NCT00154310|Primary|Renal Function (Nankivell Formula) at Month 12 Post Transplantation.|Renal function at the end of the trial assessed as mean absolute values of the glomerular filtration rate (GFR) calculated by Nankivell formula 12 months after renal transplantation. The Nankivell formula: GFR = 6.7 / Scr + BW / 4 – Surea / 2-100 / (height)^2 + C ; where Scr is the serum creatinine concentration expressed in mmol/L, BW the body weight in kg, Surea the serum urea in mmol/L, height in m, and the constant C is 35 for male and 25 for female patients. Estimated GFR is expressed in mL/min per 1.73m^2.|at Month 12 post transplantation|Intent to Treat Population (randomized patients); Last Observation Carried Forward (LOCF). One patient in||mL/min /1.73m^2||Standard Deviation|Mean
710057|NCT00154375|Secondary|Number of Participants With Death, Other Serious or Clinically Significant Adverse Events (AEs) or Related Discontinuations|National Cancer Institute (NCI)/ National Institute of Health (NIH) provides a grading (severity) scale for each AE term. Grade 3 refers to severe AE and Grade 4 refers to life-threatening or disabling AE. According to FDA 21CFR 314.80, a serious adverse event (SAE) is described as any adverse event that leads to death, is life threatening ( NIH criteria Grade 4), causes or prolongs hospitalization, results in a congenital anomaly, or any other important medical event not described above.|6 months - 1 year|The safety population consisted of randomized patients with at least one dose of randomized medication.||Participants|||Number
710058|NCT00154375|Primary|Percentage of Participants With Progression Free Survival (PFS) During the Study Duration|PFS was defined as the time from the date of randomization to the date of the first documented progression according to the MacDonald criteria, or death due to any cause. MacDonald criteria are standard criteria in neurooncology. Tumor assessment was made according to the adapted MacDonald criteria based on the combined evaluation of 1) assessment of the MRI scan for measurable, evaluable, and new lesions (made by the independent external expert too), 2) overall assessment of neurological performance (made by the investigator), 3) concomitant steroid use (as reported by the investigator).|6 months -1 year|The ITT population consists of all randomized patients, analyzed according to their randomized treatment.||Percentage of Participants||95% Confidence Interval|Number
710059|NCT00154466|Secondary|Angiogenic Cytokines at Baseline and 3-month Follow-up|Angiogenic cytokines such as vascular endothelial growth factor (VEGF), stromal-derived factor-1 (SDF-1) and stem cell factor (SCF) are known to increase the formation of new vessels at ischaemic sites and thus enhance myocardial perfusion. To rule out any effect of short-term exercise on cytokines levels, blood samples were always taken after at least 72 h of physical inactivity and overnight fasting when the subject had rested in the sitting position for at least 10 min. The plasma samples were immediately frozen and stored at −70°C. High-sensitivity ELISA (Bender MedSystems, R&D) were used to measure plasma levels of SCF, SDF-1 and VEGF according to the manufacturer’s protocols.|3 months|We calculated that we would need 18 patients in each group to achieve a power of at least 80% to detect a 20% difference in MBF change between study groups, with a two-sided significance level of p<0.05, and a 20% increase for the stress MBF change from baseline to 3 months' follow-up. The analysis was intention-to-treat.||pg/ml||Standard Deviation|Mean
710082|NCT00149825|Primary|Remission of Depression (%)|"Percent of participants in depressive remission at 12 weeks. Remission of depression was required both an HRSD score ≤ 7 and absence of the two core symptoms of MDD based on the depression module of the SCID.
The HRSD (Hamilton Rating of Depression Scale) measure depressive symptom severity. TIt has 17 items. The score ranges between 0 and 48. A score below 7 represents minimal symptoms.
The SCID rates 9 symptoms of depression as present or absent. The two core symptoms of depression are sadness and anhedonia (low motivation and/or enjoyment in significant life domains)."|After 12 weeks or at the last available time point|||percent of participants|||Number
710060|NCT00154466|Primary|Myocardial Blood Flow at Baseline and 3-month Follow-up|First-pass, contrast-enhanced myocardial perfusion images acquired for 80 heart beats in the left ventricle. Short-axis views were obtained after intravenous administration of gadodiamide. Perfusion studies were performed at rest and during the stress induced by a 4 min infusion of dipyridamole at a concentration of 0.14 mg/kg of body weight per minute.To determine absolute MBF values at rest and stress status, we adopted a model-independent deconvolution method proposed by Jerosch-Herold et al, a method that was previously validated in experimental animal studies by comparison with blood-flow measurements with radiolabelled microspheres.|3 months|Eligible patients were randomly assigned to the training group, which underwent a 3-month cardiac rehabilitation program, or the nontraining group in which patients continued their usual lifestyle. Healthy controls underwent the test of myocardial perfusion only at baseline. The analysis was intention-to-treat.||ml/min/g||Standard Deviation|Mean
710061|NCT00149630|Secondary|Retention by Treatment Condition.|Treatment retention for full 12 weeks of study.|12 weeks|74 cocaine and opioid-codependent(DSM-V)subjects were stabilized on methadone for 2 weeks and subsequently randomized into disulfiram (250 mg/day, n=34) and placebo groups (n=40) for 10 weeks. We genotyped the DBH gene polymorphism that reduced DBH enzyme levels and evaluated its role for increasing cocaine free urines with disulfiram.||% of subjects who complete 12 wks study|||Number
710062|NCT00149630|Primary|Urine Toxicology for Cocaine.||Thrice weekly, baseline through week 14.|74 cocaine and opioid-codependent (DSM-V) subjects were stabilized on methadone for 2 weeks and subsequently randomized into disulfiram (250mg/day, n=34) and placebo groups (n=40) for 10 weeks. We genotyped the DBH gene polymorphism that reduces DBH enzyme levels and evaluated its role for increasing cocaine free urines with disulfiram.||% cocaine + urines over 2 week blocks||Standard Error|Mean
710063|NCT00149643|Secondary|Number of Cannabis Use Disorder Criterion Met at a Particular Time Point.|Criterion used in this study was the number of DSM-IV cannabis use disorder symptoms (criteria) that were met.|12 Weeks|||Number of DSM-IV criterion||Standard Deviation|Mean
710064|NCT00149643|Primary|Depression Symptoms at Week 12|Average of Beck Depression Inventory (BDI) Scores measured at Weeks 1-4, 6, 8, 10 and 12. The BDI is a subject reported measure that has a minimim score of 0 and a maximum score of 63. A better outcome would consist of values near the minimum end of the scale (0) and a worse outcome would consist of values near the maximum end of the scare (63). Each DSM-IV criteron asses a different depressive symptom.|12 Weeks|||BDI Total||Standard Deviation|Mean
710065|NCT00149643|Primary|Days Per Week of Cannabis Use.|The number days out of the last seven days that cannabis was used.|12 Weeks|||Days of cannabis use per week||Standard Deviation|Mean
710066|NCT00149669|Other Pre-specified|Cocaine Positive Urine Samples|The number of urine samples that were positive for cocaine|6 months|These data were not analyzed due to limited funding. Funding this project has ended and we have no money to continue any summary or analyses.|||||
710067|NCT00149669|Other Pre-specified|Percentage of Urine/Breath Samples Negative for Other Drugs of Abuse|The percentage of urine and breath samples that are negative for other drugs of abuse|6 months|These data were not analyzed due to limited funding. Funding this project has ended and we have no money to continue any summary or analyses.|||||
710068|NCT00149669|Other Pre-specified|Cost Benefit Analysis|The costs and economic benefits of the intervention|6 months|These data were not analyzed due to limited funding. Funding this project has ended and we have no money to continue any summary or analyses.|||||
710069|NCT00149669|Other Pre-specified|HIV Risk Behaviors|Behaviors that place participants at risk for acquiring or transmitting HIV|6 months|These data were not analyzed due to limited funding. Funding this project has ended and we have no money to continue any summary or analyses.|||||
710070|NCT00149669|Secondary|Percentage of Urine Samples Negative for Opiates|The number of urine samples negative for opiates divided by the total number of urine samples times 100.|6 months|intent to treat||Percentage of Urine Samples||Full Range|Mean
710071|NCT00149669|Secondary|Percentage of Urine Samples Negative for Cocaine|the number of urine samples that were negative for cocaine divided by the total number of urine samples) x 100|6 months|intent to treat||Percentage of Urine Samples||Full Range|Mean
710072|NCT00149669|Primary|Percentage of Urine Samples Positive for Naltrexone|The number of urine samples positive for naltrexone divided by the total number of urine samples times 100.|6 months|intent to treat||Percentage of Urine Samples||Full Range|Mean
710073|NCT00149747|Secondary|Peak Exercise Oxygen Consumption|Peak oxygen consumption measured during symptom limited treadmill exercise stress test|12 months|||mL of 02 per Kg per minute||Standard Deviation|Mean
710074|NCT00149747|Secondary|Sleep Disturbances|"Self-reported sleep disturbance subscale on Pittsburgh Sleep Quality Index Subscale consists of 9 items scored on a range of 0 to 3, 0 indicating no disturbance and 3 indicating frequent disturbance.
All 9 items are summed, and the summary scores is captured by 1 of 4 categories ranging from 0 to 3, with 0 indicating less frequent disturbances and 3 indicating greater frequency of disturbances."|12 months|Intent to treat||units on a scale||Standard Deviation|Mean
710075|NCT00149747|Primary|% Time in Stage 2 Sleep at 12 Months, Adjusted for Baseline|Percent of total sleep time spent in Stage 2 sleep at 12 months after adjusting for baseline level of Stage 2 sleep (i.e., baseline value included as a covariate in regression models conducted).|baseline, 12 months|Intent to Treat||percentage of sleep time||Standard Deviation|Mean
710076|NCT00149799|Secondary|Depressive Symptoms (as Measured by the HAM-D)||Measured biweekly for six months after randomization||||||
710077|NCT00149799|Secondary|Psychosocial Functioning (as Measured by the LIFE-RIFT)||Measured four times throughout study (Weeks 0, 14, 28, and 40)||||||
710078|NCT00149799|Secondary|Q-LES-Q Short Form||Measured four times throughout study (Weeks 0, 14, 28, and 40)||||||
710079|NCT00149799|Secondary|Phase I Response to Escitalopram (as Measured by the BDD-YBOCS)|We calculated the proportion of patients who achieved response in Phase I, defined as a >=30% reduction in BDD-YBOCS total score from baseline through the last phase 1 visit.|Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14|||percentage of subjects who responded|||Number
710080|NCT00149799|Primary|Phase II Relapse of Body Dysmorphic Disorder (BDD) Symptoms (as Measured by the BDD-YBOCS)|We compared the rate of relapse (accounting for time from randomization to relapse and censoring) by treatment arm in Phase II.|Phase II: Biweekly for six months after randomization|Intent-to-treat analysis of all 58 patients randomized to Phase II.||percentage of subjects who relapsed|||Number
710084|NCT00149890|Secondary|Time of Onset of a First Biopsy Proven Acute Rejection|Biopsied Tissue shows rejection at onset 2-60 days after transplantation, with interstitial vascular endothelial cell swelling, interstitial accumulation of lymphocytes, plasma cells, immunoblasts, macrophages, neutrophils; tubular separation with edema/necrosis of tubular epithelium; swelling and vacuolization of the endothelial cells, vascular edema, bleeding and inflammation. Clinical signs and symptoms include malaise, fever and hypertension|6 months|safety/Intent to Treat (ITT) population||Months||95% Confidence Interval|Median
710085|NCT00149890|Secondary|Number of Participants With Bacterial, Viral and Fungal Infections During Six Months|To evaluate the safety of a regimen with intraoperative versus without intraoperative steroids in combination with basiliximab, cyclosporine/cyclosporine microemulsion and steroids as measured by the episodes of bacterial, viral and fungal infections during six months.|6 months|Safety Population||Participants|||Number
710086|NCT00149890|Secondary|Percentage of Participants Experiencing Death or Graft Loss Within Three and Six Months After Transplantation|Graft loss is defined as being listed for a re-transplantation.|3 months and 6 months|safety/Intent to Treat (ITT) population||Percentage of participants|||Number
710087|NCT00149890|Secondary|Number of Participants With Steroid Resistant Rejection Episodes Within Three and Six Months|To evaluate the efficacy of a regimen with intraoperative versus without intraoperative steroids in combination with basiliximab, cyclosporine/cyclosporine microemulsion and steroids as measured by the incidence of steroid resistant rejection episodes within three and six months.|3 and 6 months|safety/Intent to Treat (ITT) population||Participants|||Number
710088|NCT00149890|Secondary|Number of Participants With Biopsy Proven Acute Rejection (BPAR) Episodes Within the First Three Months|At biopsy of transplanted tissue sample, acute rejection has an onset 2-60 days after transplantation, with interstitial vascular endothelial cell swelling, interstitial accumulation of lymphocytes, plasma cells, immunoblasts, macrophages, neutrophils; tubular separation with edema/necrosis of tubular epithelium; swelling and vacuolization of the endothelial cells, vascular edema, bleeding and inflammation. Clinical signs and symptoms include malaise, fever, and hypertension.|3 months|safety/Intent to Treat (ITT) population||Participants|||Number
710089|NCT00149890|Primary|Number of Participants With at Least One Biopsy Proven Acute Rejection (BPAR) Episode, Graft Loss or Death Within the First Three Months Post-transplantation|Graft loss is defined as being listed for a re-transplantation. The analysis was based on the locally performed biopsy assessments. Generally, patients not experiencing a relevant event (i.e., acute rejection, graft loss or death) were censored with the last visit date.|3 months after treatment|safety/Intent to Treat (ITT) population||Participants|||Number
710094|NCT00156065|Primary|Median Survival Time of Effect|"Kaplan-Meier estimate of median time to loss of effect in subjects who had >=30% decrease from baseline in PANSS score at the end of the original trial (NCT00156104) preceding the long-term extension.
PANSS is a 30-item clinician-rated instrument for assessing symptoms of schizophrenia. Scores range from 30-210; higher scores indicate greater severity.
Loss of effect = increase in total PANSS >=30% from start of current study; subjective worsening of schizophrenia/request for dose increase; Clinical Global Impressions of Severity of Illness score >=6; discontinuation for lack of efficacy."|52 Weeks|These are participants who completed the original acute-phase trial (41023) with a decrease from baseline in Positive and Negative Syndrome Scale (PANSS) score >= 30%, received at least one dose in the current long-term extension, and had at least one post-baseline PANSS assessment during the extension.||Days||95% Confidence Interval|Median
710095|NCT00156065|Primary|Loss of Effect Over Time|"Loss of effect in subjects who had >=30% decrease from baseline in Positive and Negative Syndrome Scale (PANSS) score at the end of the original trial (NCT00156104) preceding the long-term extension.
PANSS is a 30-item clinician-rated instrument for assessing symptoms of schizophrenia. Scores range from 30-210; higher scores indicate greater severity.
Loss of effect = increase in total PANSS >=30% from start of current study; subjective worsening of schizophrenia/request for dose increase; Clinical Global Impressions of Severity of Illness score >=6; discontinuation for lack of efficacy."|Throughout the 52 weeks of the trial.|These are participants who completed the original acute-phase trial (41023) with a decrease from baseline in Positive and Negative Syndrome Scale (PANSS) score >= 30%, received at least one dose in the current long-term extension, and had at least one post-baseline PANSS assessment during the extension.||Participants|||Number
710096|NCT00156910|Secondary|Change in Frequency of Migraine/Probable Migraine Headache Episodes|Mean change from baseline in frequency (number) of migraine/probable migraine headache episodes during the 28 day period ending with Week 24. Headache episode defined as patient-reported headache with a start and stop time indicating that the pain lasted >= 4 continuous hours and met ICHD-II criteria for migraine or probable migraine.|Baseline, Week 24|Intent to Treat||Migraine/Prob Migraine Headache Episodes||Standard Deviation|Mean
710097|NCT00156910|Secondary|Change in Frequency of Migraine/Probable Migraine Headache Days|Mean change from baseline in frequency (number) of migraine/probable migraine headache days during the 28 day period ending with Week 24. Headache day defined as a calendar day with >= 4 continuous hours of headache meeting ICHD-II criteria for migraine or probable migraine.|Baseline, Week 24|Intent to Treat||Migraine/Probable Migraine Headache Days||Standard Deviation|Mean
710098|NCT00156910|Secondary|Change in Frequency of Acute Headache Pain Medication Intakes|Mean change from baseline in frequency (number) of acute headache pain medication intakes during the 28 day period ending with Week 24. Medication intakes defined as the number of times a patient took acute headache pain medication regardless of dose or type/number of medications taken at the same time.|Baseline, Week 24|Intent to Treat||Medication Intakes||Standard Deviation|Mean
710099|NCT00156910|Secondary|Change in Frequency of Headache Days|Mean change from baseline in frequency (number) of headache days during the 28 day period ending with Week 24. Headache day defined as a calendar day [00:00 to 23:59] for which the patient reported >= 4 continuous hours of headache|Baseline, Week 24|Intent to Treat||Headache Days||Standard Deviation|Mean
710101|NCT00156923|Primary|Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE)|A TEAE is any adverse event (AE), whether or not considered drug-related, that develops or worsens in severity after study drug administration begins (ie, from the first administration in this extension through the end of the follow-up period).|Up to 3.5 years of monthly treatment|Subjects who received at least 1 injection of study drug were included in the safety analyses||Participants|||Number
710102|NCT00156936|Primary|Number of Subjects Who Reported at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study.|A TEAE is any adverse event (AE), whether or not considered drug-related, that develops or worsens in severity after study drug administration begins (ie, from the first administration through the end of the follow-up period).|Up to 3 years|Safety population includes all enrolled subjects who received at least 1 dose of study drug (VIVITROL 380 mg) in this extension study.||Participants|||Number
710139|NCT00157157|Post-Hoc|Factor VIII Inhibitor Risk Factor: Number of Participants With Intensive Treatment and High Dose (≤20 Exposure Days (EDs))|Immunogenicity Analysis Set- Participants with 5 consecutive study days of a mean infusion dose of FVIII >50 IU/kg within ≤20 EDs who developed an inhibitor|Duration of study which was to be at least 75 exposure days or 3 years (whichever came first)|Immunogenicity Analysis Set- Participants who developed an inhibitor or who were inhibitor-free with ≥10 exposure days to rAHF-PFM||Participants|||Number
710140|NCT00157157|Post-Hoc|Factor VIII Inhibitor Risk Factor: Race|Number of treated participants who developed an inhibitor|Duration of study which was to be at least 75 exposure days or 3 years (whichever came first)|Immunogenicity Analysis Set- Participants who developed an inhibitor or who were inhibitor-free with ≥10 exposure days to rAHF-PFM||Participants|||Number
710141|NCT00157157|Post-Hoc|Factor VIII Inhibitor Risk Factor: Genetic Risk Factor- Family History of Inhibitors|Number of treated participants who developed an inhibitor|Duration of study which was to be at least 75 exposure days or 3 years (whichever came first)|Immunogenicity Analysis Set- Participants who developed an inhibitor or who were inhibitor-free with ≥10 exposure days to rAHF-PFM||Participants|||Number
710142|NCT00157157|Secondary|Development of Antibodies to Heterologous Proteins|Percentage of treated participants who developed antibodies to heterologous proteins (ie, Chinese Hamster Ovary Cell Protein, Murine IgG, or Recombinant Human VWF)|Assessed at baseline, throughout the duration of the study, which was to be at least 75 exposure days or 3 years (whichever came first), and at the termination visit.|Participants who received at least 1 infusion of rAHF-PFM and had assessments of heterologous antibodies||Percentage of Participants|||Number
710143|NCT00157157|Secondary|Adverse Events Deemed Related to Treatment|Percentage of participants who reported AEs deemed related to treatment with rAHF-PFM|Reported during the study period which was to be at least 75 exposure days or 3 years (whichever came first)|Participants who received at least 1 infusion of rAHF-PFM||Percentage of Participants|||Number
710144|NCT00157157|Secondary|Assessment of Blood Loss During Surgical Procedures|Percentage of actual intraoperative blood loss compared to preoperatively predicted average and maximal blood loss in hemostatically normal matched individuals (from institutional blood bank records)|Predicted volumes preoperatively estimated and actual volumes intraoperatively recorded|Number of participants who underwent a surgical procedure with blood loss assessments||Percentage Blood Loss||Full Range|Median
710145|NCT00157157|Secondary|Assessment of Postoperative Hemostasis|"Number of surgical procedures managed with rAHF-PFM and with investigator's assessment of hemostasis based on a 4-point ordinal scale:
Excellent: hemostasis was as good as or better than other licensed factor VIII products for matched procedure
Good: hemostasis was probably as good as other licensed factor VIII products for matched procedure
Fair: hemostasis was clearly < optimal for matched procedure, without need to change regimen
None: bleeding from inadequate response with proper dosing, necessitating a change in regimen"|Assessed at the time of discharge from hospital or clinic|Number of participants who underwent a surgical procedure with a postoperative assessment of hemostatic efficacy||Procedures|||Number
710146|NCT00157157|Secondary|Assessment of Intra-operative Hemostasis|"Number of surgical procedures managed with rAHF-PFM and with surgeon's assessment of hemostasis based on a 4-point ordinal scale:
Excellent: ≤ average predicted blood loss for matched procedures in healthy individuals
Good: > average predicted blood loss, but ≤ maximal predicted blood loss for matched procedures in healthy individuals
Fair: > maximal predicted blood loss for matched procedures in healthy individuals, and hemostasis was achieved
None: uncontrolled hemostasis with proper dosing, necessitating a change in treatment regimen"|Assessed at the time of discharge from recovery room|Number of participants who underwent a surgical procedure with an intraoperative assessment of hemostatic efficacy||Procedures|||Number
710147|NCT00157157|Secondary|In Vivo Incremental Recovery|Change in factor VIII concentration from pre- to post-infusion at initial and termination study visits.|30 minutes pre-infusion to 30 minutes post-infusion|Participants who received pharmacokinetic rAHF-PFM infusions, did not develop inhibitors, and had assessments||IU/dL per IU/kg||Full Range|Median
710148|NCT00157157|Secondary|Weekly rAHF-PFM Utilization|"Weight-Adjusted Weekly Dose for Prophylaxis, On-Demand Treatment, and Perioperative Management.
rAHF-PFM dose determined by the investigator (ie: standard regimen [25-50 IU/kg body weight, 3-4 times per week]; modified prophylactic regimen [dose and frequency selected by investigator] or on–demand treatment [dose selected by investigator]). Dosing to treat BEs was at investigator's discretion and in accordance with institution’s standard of care.
rAHF-PFM was administered I.V. via bolus infusion, except for perioperative management when it was given either by continuous or bolus infusion."|Reported during study period which was to be at least 75 exposure days or 3 years (whichever came first)|Participants treated for at least 3 months with investigator-defined on-demand treatment (for dose) or prophylaxis (for dose and infusion frequency) for >80% of the treatment period||IU/kg||Full Range|Median
710149|NCT00157157|Secondary|Annualized Rate of Bleeding Episodes|Number of bleeding episodes per subject annualized over 1 year for all etiologies|Reported during study period which was to be at least 75 exposure days or 3 years (whichever came first)|Participants treated for at least 3 months with investigator-defined on-demand treatment (for dose) or prophylaxis (for dose and infusion frequency) for >80% of the treatment period||bleeding episodes per subject per year||Full Range|Median
710150|NCT00157157|Secondary|Assessment of Hemostasis for Treatment of Bleeding Episodes|"Number of rAHF-PFM-treated bleeding episodes with treater assessment of hemostasis (4-point ordinal scale):
Excellent: Full pain relief & bleeding cessation within ~8 hrs of 1 infusion. Additional infusions may have been given to maintain hemostasis;
Good: Definite pain relief and/or improvement in bleeding within ~8 hrs after infusion. Possibly requires >1 infusion for complete resolution;
Fair: Probable or slight relief of pain & slight improvement in bleeding within ~8 hrs after infusion. Requires >1 infusion for complete resolution; or
None: No improvement or condition worsens."|Reported during study period which was to be at least 75 exposure days or 3 years (whichever came first)|"Participants who received at least 1 infusion of rAHF-PFM and had at least 1 treated bleeding episode. The 1 rating of none was for the first 2 infusions, the last infusion was rated as good."||bleeding episodes|||Number
710151|NCT00157157|Secondary|Bleeding Episodes Treated With 1 to ≥4 Infusions|The number of bleeding episodes treated with 1, 2, 3, or ≥4 infusions of rAHF-PFM to achieve adequate hemostasis|Reported during study period which was to be at least 75 exposure days or 3 years (whichever came first)|Participants who received at least 1 infusion of rAHF-PFM for the treatment of bleeding episodes||Bleeding episodes|||Number
710152|NCT00157157|Primary|Factor VIII Inhibitor Development|Percentage of treated participants who developed factor VIII inhibitors|Assessed during study period which was to be at least 75 exposure days or 3 years (whichever came first)|Participants who received at least 1 infusion of rAHF-PFM||percentage||95% Confidence Interval|Number
711280|NCT00176852|Secondary|Determine Physical Characteristics and Biologic Effects of Mixed Populations of Donor and Host Red Blood Cells||During study|The Principal Investigator removed this as a study objective.|||||
710153|NCT00157196|Secondary|Progression Free Survival (PFS) Time|PFS was defined as duration from first administration of trial treatment until progressive disease [PD] (radiological or clinical, if radiological progression is not available) or death due to any cause. Participants without event were censored on the date of last tumor assessment. Clinical assessments were performed 4 weekly in primary treatment and 6 weekly in maintenance treatment.|Up to data cut-off date (17 September 2007)|Safety analysis set included all the enrolled participants who received at least one dose of the trial treatment.||months||95% Confidence Interval|Median
710154|NCT00157196|Secondary|Survival Time|Survival time was to be measured from study entry (date of cyclophosphamide administration) to date of death. For subjects alive or lost to follow-up at time of analysis, the time between date of cyclophosphamide administration and date on which the subject was last known alive was to be calculated and used as a censored observation in the analysis.|Up to data cut-off date (17 September 2007)|Safety analysis set included all the enrolled participants who received at least one dose of the trial treatment.||months||95% Confidence Interval|Median
710155|NCT00157196|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs With CALGB-ECTC Grade 3 or 4, TEAEs Leading to Discontinuation, TEAEs Leading to Death, and Injection Site Reactions (ISRs)|TEAEs occurred between the first dose of study drug and up to 42 days after the last dose that were absent before treatment or that worsened relative to pretreatment state. A serious TEAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs with Cancer and Leukemia Group B Extended Clinical Toxicity Criteria (CALGB-ECTC) Grade 3 or 4 were also reported.|Up to data cut-off date (17 September 2007)|Safety analysis set included all the enrolled participants who received at least one dose of the trial treatment.||participants|||Number
710156|NCT00157209|Secondary|Number of Participants With Elevated CA27-29 Antigen Levels|CA 27-29 is a blood test used to monitor certain types of cancer. CA 27-29 is the name of an antigen, which is a substance that stimulates your body's defense system. CA27-29 antigen levels were determined on all participants and assessed the disease burden of participants at study entry, evaluated early recurrence, presence of residual disease, continued remission or poor prognosis.|Study entry, Week 8|"Analysis population included all randomized participants. n signifies number of participants evaluable at each timepoint for this outcome measure, for each reporting group, respectively."||participants|||Number
710157|NCT00157209|Secondary|Number of Participants With Positive T-cell Proliferation|T-cell proliferation assays were performed and the number of participants with positive mucinous glycoprotein 1 (MUC1) specific T-cell proliferative response were reported.|Time from randomization until cut-off date (15 March 2006)|"Analysis population included all randomized participants. N signifies total number of participants who were evaluable for this measure. T-cell measure was done only on arm A where subjects received tecemotide for induction of t-cell response. Therefore arm B BSC did not have any samples taken for this assessment."||participants|||Number
710158|NCT00157209|Secondary|Functional Assessment of Cancer Therapy (FACT-L) Questionnaire Score|Functional Assessment of Cancer Therapy - Lung cancer (FACT-L) is a valid instrument used to measure quality of life (QoL) in participants with cancer consisting of the 27-item FACT-General (G) and 9-item lung cancer subscale (LCS). FACT-G is organized into subscales: physical well-being (PWB)–7 items; social/family well-being (SWB)–7 items; emotional well-being (EWB)–6 items; functional well-being (FWB)–7 items. Each item uses a 5 point rating scale (0=“not at all” and 4=equals “very much”). FACT-L total score=4 subscales + LCS and ranges from 0 to 144. Higher scores indicate better QOL.|At baseline, Week 4, Week 8 and then at 12 Week intervals beginning at week 19 until withdrawal/discontinuation from the study.|"Analysis population included all the participants with a baseline and at least one post-baseline complete FACT-L questionnaire. n signifies number of participants evaluable at each timepoint for this outcome measure, for each reporting group, respectively."||Units on a scale||Standard Deviation|Mean
710159|NCT00157209|Primary|Overall Survival Time|Time from randomization to death or last day known to be alive. Participants without event were censored at the last date known to be alive or at the clinical cut-off date (15 March 2006), whichever was earlier.|Time from randomization to death or last day known to be alive, reported between day of first participant randomized that is, 08 August 2000, up to cut-off (15 March 2006)|Analysis population included all randomized participants.||months||95% Confidence Interval|Median
710160|NCT00157209|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death, and TEAEs With Cancer and Leukemia Group B (CALGB) Toxicity Grade 3 or 4|An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. A serious AE was an AE that results in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with TEAEs, serious TEAEs, TEAEs leading to death, and TEAEs with CALGB toxicity Grade 3 or 4 were reported.|From the first dose of study drug administration until 30 days after the last dose of study drug administration or assessed until cut-off date (15 March 2006)|Analysis population included all participants randomized in the study.||participants|||Number
710161|NCT00157248|Secondary|Laboratory Analyses|"Frequency of patients with possible clinically significant abnormalities, i.e. with values out of normal range.
Normal ranges are defined as:
Alanine aminotransferase (ALT): 5-45 [U/L]
Aspartate aminotransferase (AST): 10-40 [U/L]
Bilirubin, total: 0.2-1.0 [mg/dL]"|5 years|All treated patients.||participants|||Number
710172|NCT00157248|Secondary|Yearly Event Rate for Transient Ischaemic Attacks|Time to first occurrence of any transient ischaemic attacks. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25|5 years|All treated patients. In this non-randomized follow-up study, most patients changed treatment regimens per amendment during conduct and treatment exposure was not comparable between regimens. Events were assigned to the regimen a patient received prior to the event, and patients may be counted in multiple regimens. No statistical analysis was done.||yearly event rate (percentage)|||Number
715981|NCT00265330|Primary|Mean Change From Baseline in Supine Systolic Blood Pressure|Mean Change: vital sign value at observation minus vital sign value at baseline|Week 1 through Week 26|||millimeters of mercury (mm Hg)||Standard Deviation|Mean
710162|NCT00157248|Primary|Yearly Event Rate for Minor Bleeding|"Time to first occurrence of minor bleeding. A minor bleeding event is any bleed that does not qualify as a major bleed. All minor bleeding events not fulfilling one of the criteria for clinically relevant were classified as nuisance bleeds.
Clinically-relevant was defined as spontaneous skin hematoma ≥25 cm², spontaneous nose bleed >5 min, macroscopic hematuria spontaneous or lasting longer than 24 hours if associated with an intervention, spontaneous rectal bleeding, gingival bleeding >5 min, leading to hospitalization, leading to a transfusion of <2 units of packed cells or whole blood and any other bleeding event considered clinically relevant by the investigator.
Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25"|5 years|All treated patients. In this non-randomized follow-up study, most patients changed treatment regimens per amendment during conduct and treatment exposure was not comparable between regimens. Events were assigned to the regimen a patient received prior to the event, and patients may be counted in multiple regimens. No statistical analysis was done.||yearly event rate (percentage)|||Number
710163|NCT00157248|Secondary|Severe Adverse Event|Frequency of patients with severe adverse events.|5 years|All treated patients.||participants|||Number
710164|NCT00157248|Secondary|Yearly Event Rate for Composite Secondary Endpoint of Ischaemic Stroke, Transient Ischaemic Attacks, Non-central Nervous System Systemic Thromboembolism, Myocardial Infarction, Other Major Adverse Cardiac Events and All-cause Mortality|"Time to first occurrence of ischaemic stroke, transient ischaemic attacks, non-central nervous system systemic thromboembolism, myocardial infarction, other major adverse cardiac events and all-cause mortality.
Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25"|5 years|All treated patients. In this non-randomized follow-up study, most patients changed treatment regimens per amendment during conduct and treatment exposure was not comparable between regimens. Events were assigned to the regimen a patient received prior to the event, and patients may be counted in multiple regimens. No statistical analysis was done.||yearly event rate (percentage)|||Number
710165|NCT00157248|Primary|Yearly Event Rate for Any Bleeding|Time to first occurrence of any bleeding event. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25|5 years|All treated patients. In this non-randomized follow-up study, most patients changed treatment regimens per amendment during conduct and treatment exposure was not comparable between regimens. Events were assigned to the regimen a patient received prior to the event, and patients may be counted in multiple regimens. No statistical analysis was done.||yearly event rate (percentage)|||Number
710166|NCT00157248|Primary|Yearly Event Rate for Major + Minor/Relevant Bleeding|Time to first occurrence of either major or minor/relevant bleeding. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25|5 years|All treated patients. In this non-randomized follow-up study, most patients changed treatment regimens per amendment during conduct and treatment exposure was not comparable between regimens. Events were assigned to the regimen a patient received prior to the event, and patients may be counted in multiple regimens. No statistical analysis was done.||yearly event rate (percentage)|||Number
710167|NCT00157248|Primary|Yearly Event Rate for Major Bleeding|"Time to first occurrence of fatal or life-threatening, retroperitoneal, intracranial, intraocular, or intraspinal bleeding, which required surgical treatment, led to a transfusion of a minimum of 2 units of packed cells or whole blood, or led to a fall in hemoglobin of 20g/L or less.
Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25"|5 years|All treated patients. In this non-randomized follow-up study, most patients changed treatment regimens per amendment during conduct and treatment exposure was not comparable between regimens. Events were assigned to the regimen a patient received prior to the event, and patients may be counted in multiple regimens. No statistical analysis was done.||yearly event rate (percentage)|||Number
710168|NCT00157248|Secondary|Yearly Event Rate of Death|Time to death of any cause. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25|5 years|All treated patients. In this non-randomized follow-up study, most patients changed treatment regimens per amendment during conduct and treatment exposure was not comparable between regimens. Events were assigned to the regimen a patient received prior to the event, and patients may be counted in multiple regimens. No statistical analysis was done.||yearly event rate (percentage)|||Number
710169|NCT00157248|Secondary|Yearly Event Rate of Other Major Adverse Cardiac Events|Time to first occurrence of any other major adverse cardiac events. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25|5 years|All treated patients. In this non-randomized follow-up study, most patients changed treatment regimens per amendment during conduct and treatment exposure was not comparable between regimens. Events were assigned to the regimen a patient received prior to the event, and patients may be counted in multiple regimens. No statistical analysis was done.||yearly event rate (percentage)|||Number
710170|NCT00157248|Secondary|Yearly Event Rate of Myocardial Infarction|Time to first occurrence of any myocardial infarction. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25|5 years|All treated patients. In this non-randomized follow-up study, most patients changed treatment regimens per amendment during conduct and treatment exposure was not comparable between regimens. Events were assigned to the regimen a patient received prior to the event, and patients may be counted in multiple regimens. No statistical analysis was done.||yearly event rate (percentage)|||Number
710171|NCT00157248|Secondary|Yearly Event Rate for Systemic Thromboembolism|"Time to first occurrence of any non-central nervous system systemic thromboembolism.
Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25"|5 years|All treated patients. In this non-randomized follow-up study, most patients changed treatment regimens per amendment during conduct and treatment exposure was not comparable between regimens. Events were assigned to the regimen a patient received prior to the event, and patients may be counted in multiple regimens. No statistical analysis was done.||yearly event rate (percentage)|||Number
710173|NCT00157248|Secondary|Yearly Event Rate of Haemorrhagic Stroke|Time to first occurrence of any haemorrhagic stroke. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25|5 years|All treated patients. In this non-randomized follow-up study, most patients changed treatment regimens per amendment during conduct and treatment exposure was not comparable between regimens. Events were assigned to the regimen a patient received prior to the event, and patients may be counted in multiple regimens. No statistical analysis was done.||yearly event rate (percentage)|||Number
710174|NCT00157248|Secondary|Yearly Event Rate of Ischaemic Stroke|Time to first occurrence of any ischaemic stroke. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25|5 years|All treated patients. In this non-randomized follow-up study, most patients changed treatment regimens per amendment during conduct and treatment exposure was not comparable between regimens. Events were assigned to the regimen a patient received prior to the event, and patients may be counted in multiple regimens. No statistical analysis was done.||yearly event rate (percentage)|||Number
710175|NCT00157248|Secondary|Yearly Event Rate for Stroke|Time to first occurrence of any fatal or non-fatal stroke. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25|5 years|All treated patients. In this non-randomized follow-up study, most patients changed treatment regimens per amendment during conduct and treatment exposure was not comparable between regimens. Events were assigned to the regimen a patient received prior to the event, and patients may be counted in multiple regimens. No statistical analysis was done.||yearly event rate (percentage)|||Number
710176|NCT00157248|Primary|Yearly Event Rate for Composite Endpoint of Stroke, Transient Ischaemic Attacks, System Thromboembolism, Myocardial Infarction, Other Major Adverse Cardiac Events and Mortality.|Time to first occurrence of stroke, transient ischaemic attacks, system thromboembolism, myocardial infarction, other major adverse cardiac events and mortality. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25|5 years|All treated patients. In this non-randomized follow-up study, most patients changed treatment regimens per amendment during conduct and treatment exposure was not comparable between regimens. Events were assigned to the regimen a patient received prior to the event, and patients may be counted in multiple regimens. No statistical analysis was done.||yearly event rate (percentage)|||Number
710177|NCT00157573|Other Pre-specified|Change From Baseline of Anti-Trag Antibodies||Up to 60 months|This outcome measure was originally posted as a secondary outcome measures but was actually an exploratory endpoint. No data was collected.|||||
710178|NCT00157573|Secondary|Number of Participants With Adverse Events (Toxicity) Grade 3 or 4|Adverse Events (previously toxicity) were graded according the National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 3.0. The total number of participants with adverse events graded 3 (severe) or 4 (life-threatening or disabling) are reported.|Up to 460 days|After initial analysis, it was clear that the schedule did not significantly impact the immune response and that the WCC was the best correlate predictor of change in CA125, and so the cohorts were combined for an overall analysis. 1 participant withdrew consent and was not included in the analysis.||Participants|||Count of Participants
710179|NCT00157573|Secondary|Tumor Response Rate (RR)|RR is the percentage of patients with response as assessed by the investigator using Response Evaluable Criteria in Solid Tumors (RECIST) and CA-125 Rustin criteria. Complete Response (CR) is the disappearance of all target and non-target lesions and normalization of CA-125. Partial Response (PR) is at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; in patients with no measurable disease with an informative CA-125, the 75% definitions by Rustin is used. Stable Disease is neither sufficient shrinkage for PR nor increase for PD, taking as reference the smallest sum LD since the treatment start. PD is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since treatment start or the appearance of one or more new lesions; in patients with no measurable disease with an informative CA-125, PD is defined as a rise of > 50% over baseline, confirmed by a higher value 21 days later.|Up to 60 months|After initial analysis, it was clear that the schedule did not significantly impact the immune response and that the actual WCC was the best correlate predictor of change in CA125, and so the cohorts were combined for an overall analysis. 1 participant withdrew consent and was not included in the analysis.||Participants|||Count of Participants
710180|NCT00157573|Secondary|Median Time to Progression (TTP)|TTP was defined as the median time in days from trial entry until progressive disease (PD) was documented as defined by RECIST criteria. PD was defined of at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. In participants with no measurable disease who had an informative cancer antigen-125 (CA-125), PD was defined as a rise of > 50% over Baseline, confirmed by a subsequently higher value at least 21 days later.|Up to 60 months|No analysis was performed. No data was reported for TTP in the clinical chart that was found to be reliable or consistent in the absence of proper computed tomography (CT) surveillance.|||||
710181|NCT00157573|Primary|Median Time to Treatment Termination (TTT)|TTT is the median time in days to discontinuing treatment with GM-CSF, sargramostim (treatment termination) e.g. time on study until progression of disease, unacceptable adverse effects, bowel obstruction, development of new ascites or pleural effusions, initiation of systemic chemotherapy, participant death, development of co-morbid diseases which make participant continuation on the trial unsafe in the judgment of the principal investigator or the treating physician or withdrawal of consent by the participant.|Up to 460 days|After initial analysis, it was clear that the schedule did not significantly impact the immune response and that the actual white cell count (WCC) was the best correlate predictor of change in CA125, and so the cohorts were combined for an overall analysis. 1 participant withdrew consent and was not included in the analysis.||days||Full Range|Median
710263|NCT00152763|Primary|Impact of Events Scale-Revised - Avoidance Scale at 6-months Follow-up|Psychometric assessment of post traumatic stress disorder avoidance symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder avoidance symptoms.|Six-months follow-up|Intention to treat analysis although data from participants who died were omitted from analysis||units on a scale||Standard Deviation|Mean
710182|NCT00157755|Other Pre-specified|Change in Gastric Emptying Results at 12 Months Compared to Baseline (4 Hours)|Gastric emptying was evaluated using a standardized scintigraphy method and a low fat egg substitute test meal. After standard meal and marker preparation, the subsequent images were taken at 2 hours and 4 hours and percentage of gastric retention was evaluated. Change in 4-hour GET is calculated as % of gastric retention at 4 hours at baseline - % of gastric retention at 4 hours at 12 months. A positive change represents an improvement in gastric emptying at 12 months.|baseline and 12 months|The analysis population included subjects who were randomized, completed the study at 12 months and provided evaluable measurements.||Percent retention||Inter-Quartile Range|Median
710183|NCT00157755|Other Pre-specified|Change in Gastric Emptying Results at 12 Months Compared to Baseline (2 Hours)|Gastric emptying was evaluated using a standardized scintigraphy method and a low fat egg substitute test meal. After standard meal and marker preparation, the subsequent images were taken at 2 hours and 4 hours and percentage of gastric retention was evaluated. Change in 2-hour GET is calculated as % of gastric retention at 2 hours at baseline - % of gastric retention at 2 hours at 12 months. A positive change represents an improvement in gastric emptying at 12 months.|baseline and 12 months|The analysis population included subjects who were randomized, completed the study at 12 months and provided evaluable measurements.||Percent retention||Inter-Quartile Range|Median
710184|NCT00157755|Other Pre-specified|Change in Quality of Life at 12 Months Compared to Baseline (Mental Component Summary)|The QOL scores were collected using the SF-36 questionnaire, which included the scores in the following domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health. The raw score of 0 represents poor health and 100 represents best health. The mental component summary (MCS) score is a norm based score calculated from the raw scores of these 8 domains with a focus on mental health. The change in MCS is calculated as MCS at baseline - MCS at 12 months. A negative change in MCS represents an improvement in QOL.|baseline and 12 months|The analysis population included subjects who were randomized and completed the study at 12 months.||Scores on a scale||Standard Deviation|Mean
710185|NCT00157755|Other Pre-specified|Change in Quality of Life (QOL) at 12 Months Compared to Baseline (Physical Component Summary)|The QOL scores were collected using the SF-36 questionnaire, which included the scores in the following domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health. The raw score of 0 represents poor health and 100 represents best health. The physical component summary (PCS) score is a norm based score calculated from the raw scores of these 8 domains with a focus on physical health. The change in PCS is calculated as PCS at baseline - PCS at 12 months. A negative change in PCS represents an improvement in QOL.|baseline and 12 months|The analysis population included subjects who were randomized and completed the study at 12 months.||Scores on a scale||Standard Deviation|Mean
710186|NCT00157755|Other Pre-specified|Change in Symptom Score at 12 Months Compared to Baseline.|A symptom interview was conducted at each visit to assess vomiting, nausea, early satiety, bloating, postprandial fullness, epigastric pain and epigastric burning. The scale for each symptom ranges from 0 to 4, with 0 being absence of symptoms and 4 being extremely frequent (≥ 7 episodes per week). Total symptom score (TSS) is the sum of the individual frequency symptom scores. The change is calculated as TSS at baseline - TSS at 12 months. A positive change represents an improvement in TSS at 12 months.|baseline and 12 months|The analysis population included subjects who were randomized and completed the study at 12 months.||Scores on a scale||Standard Deviation|Mean
710187|NCT00157755|Other Pre-specified|Percentage of Responders at 12 Months|Responders were defined as having a 50% or greater reduction of WVF from baseline to 12 months. The percentage of responders was estimated as the proportion of the responders among all subjects who finished the 12-month visit. The percentage of responders was tested to determine if it was statistically greater than 50%.|baseline and 12 months|The analysis population included subjects who were randomized, completed the study at 12 months and provided evaluable measurements.||Percentage of responders|||Number
710188|NCT00157755|Secondary|Percent Reduction in the Frequency of Weekly Vomiting Episodes at 12 Months Compared to Baseline|Diaries were used to record daily vomiting episodes for 28 days prior to each office follow-up visit. The weekly vomiting frequency (WVF) was based on the average number of weekly vomiting episodes recorded in the patient diary. The percent reduction is calculated as ((WVF at baseline - WVF at 12 months)/ (WVF at baseline))*100%. A positive reduction represents an improvement in WVF at 12 months.|baseline and 12 months|The analysis population included subjects who were randomized, completed the study at 12 months and provided evaluable measurements.||Percent reduction in WVF||Full Range|Median
710189|NCT00157755|Secondary|Percent Reduction in Symptom Score When the Device is Turned ON, Relative to When the Device is Turned OFF|A symptom interview was conducted at each visit to assess vomiting, nausea, early satiety, bloating, postprandial fullness, epigastric pain and epigastric burning. The scale for each symptom ranges from 0 to 4, with 0 being absence of symptoms and 4 being extremely frequent (≥ 7 episodes per week). Total symptom score (TSS) is the sum of the individual frequency symptom scores. The percent reduction is calculated as ((TSS during OFF - TSS during ON)/ (TSS during OFF))*100%. A positive reduction represents an improvement in TSS when the device was ON.|4.5 months and 7.5 months|The analysis population included subjects who were randomized, completed the study through the end of the blinded crossover period and provided evaluable measurements.||Percent reduction in symptom score||Full Range|Median
710190|NCT00157755|Primary|Percent Reduction in Frequency of Weekly Vomiting Episodes When the Device is Turned ON, Relative to When the Device is Turned OFF|Diaries were used to record daily vomiting episodes for 28 days prior to each office follow-up visit. The weekly vomiting frequency (WVF) was based on the average number of weekly vomiting episodes recorded in the patient diary. The percent reduction is calculated as ((WVF during OFF - WVF during ON)/ (WVF during OFF))*100%. A positive reduction represents an improvement in WVF when the device was ON.|4.5 months and 7.5 months|The analysis population included subjects who were randomized, completed the study through the end of the blinded crossover period and provided evaluable measurements.||percent reduction in WVF||Full Range|Median
710264|NCT00152763|Primary|Impact of Events Scale-Revised - Avoidance Scale at Baseline|Psychometric assessment of post traumatic stress disorder avoidance symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder avoidance symptoms.|Baseline|Intention to treat analysis although data from participants who died were omitted from analysis||units on a scale||Standard Deviation|Mean
710191|NCT00157820|Secondary|Number of Each of the Components of the CSAE|"The primary endpoint is a composite of 5 pre-determine Clinical Significant Adverse Events (CSAE): (1) all-cause mortality, (2) invasive intervention due to Cardiovascular cause, (3) hospitalization (>24h) or prolongation of hospitalization due to CV, (4) inappropriate shocks: two or more episodes with inappropriate shocks, (5) sustained symptomatic ATs that (a) require urgent termination or (b) lasted more than 48 h leading to therapeutic intervention.
Number of each of the components of CSAE, counts the number of events for each pre-determined level."|17 months|||events|||Number
710192|NCT00157820|Primary|CSAE-score Rate(Clinical Significant Adverse Events Score Rate)|Main outcome was defined as the CSAE-score during follow-up: CSAE-score rate. We assigned death as the worst outcome during the entire study; and premature cross-over as the main failure of the assigned therapy. So each CSAE was assigned 1 point but (a) death was assigned a score equal to the max number of CSAE in any individual patient in the entire study +1, and (b) premature authorized crossover was given a score equal to the max number of CSAE in any individual patient in that period. Thus, main outcome was defined as the CSAE-score over length of follow-up resulting in a CSAE-score rate.|17 months|ITT||score/month|CSAE||Number
710193|NCT00157950|Secondary|Number of Participants With Adverse Experiences|Number of participants who reported 1 or more adverse experience.|Overall study including 14 calendar days after the last vaccination visit.|All participants who received at least 1 dose of injection.||Participants|||Number
710194|NCT00157950|Primary|Number of Participants Who Seroconvert to HPV 18.|Vaccine-induced anti-HPV 18 seroconversion following administration of a 3-dose regimen of GARDASIL® in females 9 to 23 years of age in Korea. Seroconversion for HPV 18 was defined as achieving an anti-HPV cLIA (Competitive Luminex immunoassay) level of at least 24 mMU/mL.|Week 4 Postdose 3|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.||Participants|||Number
710195|NCT00157950|Primary|Number of Participants Who Seroconvert to HPV 16.|Vaccine-induced anti-HPV 16 seroconversion following administration of a 3-dose regimen of GARDASIL® in females 9 to 23 years of age in Korea. Seroconversion for HPV 16 was defined as achieving an anti-HPV cLIA (Competitive Luminex immunoassay) level of at least 20 mMU/mL.|Week 4 Postdose 3|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.||Participants|||Number
710196|NCT00157950|Primary|Number of Participants Who Seroconvert to HPV 11.|Vaccine-induced anti-HPV 11 seroconversion following administration of a 3-dose regimen of GARDASIL® in females 9 to 23 years of age in Korea. Seroconversion for HPV 11 was defined as achieving an anti-HPV cLIA (Competitive Luminex immunoassay) level of at least 16 mMU/mL.|Week 4 Postdose 3|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.||Participants|||Number
710197|NCT00157950|Primary|Number of Participants Who Seroconvert to HPV 6.|Vaccine-induced anti-HPV 6 seroconversion following administration of a 3-dose regimen of GARDASIL® in females 9 to 23 years of age in Korea. Seroconversion for HPV 6 was defined as achieving an anti-HPV cLIA (Competitive Luminex immunoassay) level of at least 20 mMU/mL.|Week 4 Postdose 3|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.||Participants|||Number
710198|NCT00158054|Secondary|All-cause Mortality|All- cause mortality|18 months|||participants|||Number
710199|NCT00158054|Secondary|Number of Participants Experiencing Major Adverse Cardiovascular Events|The table represents the number of participants experiencing major adverse cardiovascular events|6 months|||participants|||Number
710200|NCT00158054|Secondary|Level of Depressive Symptoms|Depressive symptoms were measured using the Beck Depression Inventory (BDI), which is a 21-item multiple choice, self-report instrument that is used to assess the severity of symptoms of depression. The score ranges from 0 (no symptoms) to 63 (worst symptoms).|6 months|||units on a scale||95% Confidence Interval|Mean
710201|NCT00158054|Primary|Percentage of Patients That Self-reported as Satisfied With Care for Depressive Symptoms.|Number of participants who rated their depression care as excellent or very good as a percentage.|6 months|||percentage of participants|||Number
710202|NCT00158184|Secondary|Drug Liking|"Subjective rating of drug Liking on a scale of 0 to 100. Greater numbers indicate greater subjective report of Liking."|Highest rating obtained following adminstration of each of the 3 test doses.|||units on a scale||Standard Error|Mean
710203|NCT00158184|Primary|Breakpoint|"Maximum number of finger presses on a computer mouse completed. The Breakpoint is the amount of work (clicks on a mouse) participants were willing to do in order to received the dose of drug under investigation. This is a commonly used indicator of a drugs value and abuse liability."|Measured at 0, 60, 120, 180 and 240 minutes following administration of each oral oxycodone dose (0 , 15, 30 mg). Results presented as mean of the session|||Mouse Clicks||Standard Error|Mean
710204|NCT00158197|Primary|Methamphetamine Use, Follow-Up|Drug use measured by urine toxicology conducted by on site EMIT assay over time|1x/month for 4 months|||percentage of negative urine samples|Participants||Number
710205|NCT00158197|Primary|Methamphetamine Use, Measured by Number of Consecutive Days of Abstinence|Drug use measured by urine toxicology conducted by on site EMIT assay and added up to obtain how many days of consecutive abstinence were observed for each individual|16 Weeks|||days||Standard Deviation|Mean
710206|NCT00158197|Primary|Methamphetamine Use During Intervention|Drug use measured by urine toxicology conducted by on site Enzyme-multiplied immunoassay technique (EMIT) assay over time.|3x/week for 16 weeks|All individuals randomized were included in the analysis (i.e., intention to treat).||percentage of negative urine samples|Participants||Number
710207|NCT00158223|Primary|Negative Syndrome Scale (PANSS) Total Score|Severity of negative schizophrenic symptoms, The Negative Syndrome scale is compromised of seven items, each scored on severity with numeric assignments ranging from 1 = absent, 2 = minimal, 3 = mild, 4 = moderate, 5 = moderate severe, 6 = severe, and 7 = extreme. The items which comprise the Negative Syndrome Scale of the PANSS measure things such as emotional withdrawal, apathy, difficulty in abstract thinking, etc. The seven items which comprise the PANSS Negative Subscale has an aggregate range of 7 (absent) to 49 (extreme psychopathology), a higher score indicating more severe symptoms.|Variable change from baseline to week 12|||units on a scale||Standard Deviation|Mean
710208|NCT00158223|Secondary|Clinical Global Impression of Change (CGIC)|The Clinical Global Impression-improvement (CGI-improvement) scale is a research rating tool, developed for use in NIMH-sponsored clinical trials provides a brief assessment of the clinician's view of the patient's overall clinical improvement prior to and after initiating a study medication. The CGI-change is rated on a seven point scale ranging from 1= very much improved since the initiation of treatment to 7=very much worse since the initiation of treatment. Therefore, a lower score indicates more improvement in symptoms over time.|variable change from baseline to week 12|||units on a scale||Standard Deviation|Mean
710209|NCT00158223|Primary|Positive Syndrome Scale (PANSS) Total Score|Severity of positive schizophrenic symptoms The Positive Syndrome Scale of the PANSS is comprised of seven items measuring positive such symptoms such as hallucinations, delusions, grandiosity, etc. Each item is scored on a 7 point scale of that particular symptom's severity, ranging from 1 = absent, 2 = minimal, 3 = mild, 4 = moderate, 5 = moderate severe, 6 = severe, and 7 = extreme. The PANSS Positive Subscale seven items has a range of a summed score from 7 (absent) to 49 (extreme psychopathology). Therefore, the higher the score, the more severe the symtpoms.|Variable change from baseline to week 12|||units on a scale||Standard Deviation|Mean
710210|NCT00158249|Secondary|Neurocognitive Function|Multiple Source Interference Test (MSIT)|Before and after 8 weeks of treatment|||Accuracy percent improvement||Standard Error|Mean
710211|NCT00158249|Primary|Marijuana Use||Measured for 8 weeks of treatment|||Reported uses per day||Standard Error|Mean
710212|NCT00158262|Primary|Physiological Posterior Probability of PTSD as Determined From Psychophysiologic Responses During Script-Driven Mental Imagery at Month 3|The posterior probability of developing PTSD was determined for each participant from a composite of psychophysiological responses during script-driven mental imagery of traumatic events (two exemplars) that included assessments of heart rate response in beats per minute, skin conductance response in microSiemens, and corrugator and left lateral frontalis facial muscle electromyogram (EMG) responses in microVolts. Responses for the two traumatic scripts were averaged and square-root transformed for analysis. Responses during personal traumatic imagery of previously studied individuals with and without current PTSD were used to calculate each participant’s posterior probability of being classified as PTSD.|Month 3|All randomized participants with data available for analysis at Month 3. Data were missing in 6 placebo and 5 propranolol participants.||percent probability||Standard Deviation|Mean
710213|NCT00158262|Secondary|Clinician-Administered PTSD Scale (CAPS) Total Score|The clinician evaluated the overall frequency and intensity/severity of the participant's PTSD symptoms using the CAPS. 17 Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) PTSD symptoms were assessed using a 5-point scale for intensity where 0=none to 4=extreme and a 5-point scale for frequency where 0=never to 4=most or all of the time. The intensity score and the frequency scores were added together for a total possible score of 0 (best) to 136 (worst).|Months 1 and 3|All randomized participants with CAPS data available for analysis at the given time-point.||score on a scale||Standard Deviation|Mean
710214|NCT00158262|Primary|Physiological Posterior Probability of Posttraumatic Stress Disorder (PTSD) as Determined From Psychophysiologic Responses During Script-Driven Mental Imagery at Month 1|The posterior probability of developing PTSD was determined for each participant from a composite of psychophysiological responses during script-driven mental imagery of traumatic events (two exemplars) that included assessments of heart rate response in beats per minute, skin conductance response in microSiemens, and corrugator and left lateral frontalis facial muscle electromyogram (EMG) responses in microVolts. Responses for the two traumatic scripts were averaged and square-root transformed for analysis. Responses during personal traumatic imagery of previously studied individuals with and without current PTSD were used to calculate each participant’s posterior probability of being classified as PTSD.|Month 1|All randomized participants with data available for analysis at Month 1. Data were missing in 2 placebo and 2 propranolol participants.||percent probability||Standard Deviation|Mean
710215|NCT00158379|Secondary|Toxicity|defined as hematological and non-hematological adverse events of grade >= grade 1|after every cycle during therapy phase and after every 3 months during follow-up, for up to 3 years|||participants|||Number
710216|NCT00158379|Primary|Progression-free Survival. Progression is Defined According WHO-criteria as Appearance of Any New Lesion or Increase of Existing Lesions by at Least 25%|Time to progression|every 3 months for up to 3 years|||months||95% Confidence Interval|Median
710217|NCT00158600|Primary|Recombinant Human Acid Alpha-Glucosidase (rhGAA) Pharmacokinetic Parameters: Mean Time to Maximum Plasma Concentration(Tmax)|Time to maximum plasma concentration observed in blood samples taken at the following time points: 0 (before the start of the infusion), 1 and 2 hours after the start of infusion, end of the infusion, and then 0.25, 0.5, 1, 2, 3, 4, 8, 12,and 16 hours after the end of the infusion (with a 5-minute window for time-points after the start of infusion). Pooled figures combine the values for the three timeframes.|weeks 0, 12, 52|The subgroup of patients for whom pharmacokinetic samples were obtained was based on those study sites that could accommodate pharmacokinetic sampling needs.||hours||Standard Deviation|Mean
710218|NCT00158600|Primary|Recombinant Human Acid Alpha-Glucosidase (rhGAA) Pharmacokinetic Parameters: Mean Maximum Plasma Concentration(Cmax)|Maximum plasma concentration observed in blood samples taken at the following time points: 0 (before the start of the infusion), 1 and 2 hours after the start of infusion, end of the infusion, and then 0.25, 0.5, 1, 2, 3, 4, 8, 12,and 16 hours after the end of the infusion (with a 5-minute window for time-points after the start of infusion). Pooled figures combine the values for the three timeframes.|weeks 0, 12, 52|The subgroup of patients for whom pharmacokinetic samples were obtained was based on those study sites that could accommodate pharmacokinetic sampling needs.||ng/mL||Standard Deviation|Mean
710219|NCT00158600|Primary|Recombinant Human Acid Alpha-Glucosidase (rhGAA) Pharmacokinetic Parameters: Area Under the Curve (AUC)|Area under the plasma concentration versus time curve from time zero (pre-dose) to 16 hours after the end of infusion. Blood sample time points were 0 (before the start of the infusion), 1 and 2 hours after the start of infusion, end of the infusion, and then 0.25, 0.5, 1, 2, 3, 4, 8, 12,and 16 hours after the end of the infusion (with a 5-minute window for time-points after the start of infusion). Pooled figures combine the values for the three timeframes.|weeks 0, 12 and 52|The subgroup of patients for whom pharmacokinetic samples were obtained was based on those study sites that could accommodate pharmacokinetic sampling needs.||ug*h/mL||Standard Deviation|Mean
710220|NCT00158600|Secondary|Health-related Quality of Life Survey Values Related to Physical Components as Measured by the Medical Outcomes Study (MOS) Short Form-36 Health Survey|The Medical Outcomes Study Short Form (MOS SF)-36 questionnaire consists of 36 items grouped into 8 domains designed to assess generic health-related quality of life in healthy and ill adult populations. Physical Component Scores (PCS) report the four domains of physical functioning, role-physical, bodily pain, and general health. Higher scores are associated with better quality of life. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning possible. The PCS scores are reported.|weeks 0, 78|ITT population. Last observation carried forward.||Units on a scale||Standard Deviation|Mean
710221|NCT00158600|Secondary|Percent Predicted Proximal Muscle Strength of the Lower Limbs as Measured by Quantitative Muscle Testing (QMT)|Quantitative muscle testing (QMT) is a standardized system to measure muscle force production during maximal voluntary isometric contraction. QMT data were collected directly from sensors into laptop computers. Predicted normal values for QMT are based on a formula using sex, age and body mass index of a person, and is an estimate of healthy muscle force. Percent of predicted QMT = (observed value)/(predicted value) * 100%. The QMT Leg Score is the average of the bilateral means for percent predicted knee flexors and extensors. A value of 100% indicates 'normal' muscle strength.|weeks 0, 78|ITT population. Last observation carried forward.||percent predicted QMT||Standard Deviation|Mean
710222|NCT00158600|Primary|Percent of Predicted Forced Vital Capacity (FVC)|Forced vital capacity is a standard pulmonary function test used to quantify respiratory muscle weakness. Forced vital capacity (FVC) is the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. Predicted forced vital capacity is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FVC = (observed value)/(predicted value) * 100%.|weeks 0, 78|ITT population. Last observation carried forward.||percent predicted FVC||Standard Deviation|Mean
710223|NCT00158600|Primary|Mean Distance Walked as Measured by Six-minute Walk Test (6MWT) at Weeks 0 and 78, and Mean Change From Baseline|Mean distance walked gives an indication of functional endurance. The greater the distance, the greater the endurance. Mean values of distance walked in a six-minute walk test are offered for baseline, week 78 (or last available observation), and the mean change from baseline (at week 78 or last available post-baseline observation).|weeks 0, 78|Intent-to-Treat (ITT) population. Last observation carried forward. The last available distance walked for one patient was the Baseline visit; therefore, this patient was excluded from the change from baseline calculation.||meters||Standard Deviation|Mean
710224|NCT00158600|Primary|Summary of Patients Reporting Treatment-Emergent Adverse Events|Overall safety summary of patients experiencing Adverse Events (AEs), Serious Adverse Events (SAEs), treatment-related AEs, and Infusion Associated Reactions (IARs). Summary is based on Treatment-emergent AEs (TEAEs), defined as AEs that occurred following the initiation of study treatment, i.e., alglucosidase alfa or placebo.|weeks 0-78|"All patients who received any amount of study treatment comprise the safety population. Patients were considered, for safety analysis, to be in the treatment group of the treatment they actually received.
Missing or invalid safety or resource utilization data were not replaced."||participants|||Number
710225|NCT00158743|Primary|Change in Creatinine Clearance|change from baseline in creatinine clearance measured at 24 to 48 hours, comparing patients who received placebo with those who received digoxin immune fab|Baseline to 24-48 hours.|||milliliters/minute||Standard Deviation|Mean
710226|NCT00158756|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Month 0 to Month 4|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and the symptom sheet filled in.||Subjects|||Number
710227|NCT00158756|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|"Number of subjects with any unsolicited adverse events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination."|During the 31-day (Days 0-30) follow-up period|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and the symptom sheet filled in.||Subjects|||Number
710228|NCT00158756|Secondary|Number of Subjects With Any Solicited General Symptoms|Assessed solicited general symptoms were diarrhea, drowsiness, fever [defined as rectal temperature equal to or above 38.0 degrees Celsius (°C)], irritability, loss of appetite [loss of appet.] and vomiting. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination. Grade 3 loss of appetite = symptoms that prevents eating. Grade 3 diarrhea = ≥ 6 looser than normal stools per (/) day. Grade 3 vomiting = ≥ 3 episodes of vomiting/day.|During the 8-day period (Days 0-7) post-vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and the symptom sheet filled in.||Subjects|||Number
710229|NCT00158756|Secondary|Number of Subjects With Solicited Local Symptoms|Solicited local symptoms were pain, redness and swelling. Any = occurence of symptom regardless of intensity grade. Grade 3 pain = Significant pain at rest, pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling with a maximum diameter greater than 30 millimeters (mm).|During the 8-Day (Days 0-7) follow-up period|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and the symptom sheet filled in.||Subjects|||Number
710230|NCT00158756|Secondary|Anti-Polio Type 1, 2, 3 Antibody Titers|Anti-Polio type 1, 2 and 3 antibody titers were expressed as Geometric Mean Titers (GMTs).|At one month post dose 3 [PIII(M4)]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.||Titers||95% Confidence Interval|Geometric Mean
710231|NCT00158756|Secondary|Concentrations of Anti-RV Antibodies|Concentrations, expressed as Geometric Mean Concentrations (GMCs), were measured in U/mL.|At 2.5 months post dose 2 of Rotarix [PIII(M4)]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.lysis||U/mL||95% Confidence Interval|Geometric Mean
710232|NCT00158756|Secondary|Concentrations of Anti-BPT Antibodies|Concentrations, expressed as Geometric Mean Concentrations (GMCs), were measured in EL.U/mL.|At one month post dose 3 [PIII(M4)]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
710233|NCT00158756|Secondary|Concentrations of Anti-T Antibodies|Concentrations, expressed as Geometric Mean Concentrations (GMCs), were measured in international units per millillitre (IU/mL).|At one month post dose 3 [PIII(M4)]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.||IU/mL||95% Confidence Interval|Geometric Mean
710234|NCT00158756|Secondary|Concentrations of Anti-DT Antibodies|Concentrations of anti-DT antibodies, expressed as Geometric Mean Concentrations (GMCs), were measured in IU/mL.|At one month post dose 3 [PIII(M4)]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.||IU/mL||95% Confidence Interval|Geometric Mean
710235|NCT00158756|Secondary|Concentrations of Anti-HBs Antibodies|Concentrations of anti-HB, antibodies, expressed as Geometric Mean Concentrations (GMCs), were measured in mIU/mL.|At one month post dose 3 [PIII(M4)]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.||mIU/mL||95% Confidence Interval|Geometric Mean
710236|NCT00158756|Secondary|Number of Seroprotected Subjects for Anti-Poliovirus Types 1, 2, 3 (Anti-Polio 1, 2, 3)|A seroprotected subject was defined as a vaccinated subject with anti-Polio type 1,2 ,3 antibody titers ≥ 8|At one month post dose 3 [PIII(M4)]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.||Subjects|||Number
710237|NCT00158756|Secondary|Number of Seroprotected Subjects for Anti-Tetanus (Anti-T) Antigen|A seroprotected subject was defined as a vaccinated subject with anti-T antibody concentrations ≥ the cut-off value of 0.1 international units per millilitre (IU/mL).|At one month post dose 3 [PIII(M4)]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.||Subjects|||Number
710238|NCT00158756|Secondary|Number of Seropositive Subjects With Anti-rotavirus (Anti-RV) Antibodies Above the Cut-off Values|A seropositive subject was defined as a subject with anti-RV antibody concentrations ≥ 20 units per millilitre (U/mL).|At 2.5 months after dose 2 of Rotarix [PIII(M4)]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.||Subjects|||Number
710239|NCT00158756|Secondary|Number of Subjects With Vaccine Response to BPT Antigen|Vaccine response (VR) was defined as the appearance of antibodies in subjects seronegative at pre-vaccination and antibody concentrations ≥ the cut-off values post-vaccination in subjects who were seropositive at pre-vaccination.|At one month post dose 3 [PIII(M4)]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.||Subjects|||Number
710240|NCT00158756|Secondary|Number of Seropositive Subjects With Anti-Bordetella Pertussis (Anti-BPT) Antibody Concentrations ≥ the Established Cut-off Values|A seropositive subject was defined as a subject with Anti-BPT antibody concentrations ≥ 15 ELISA units per millilitre (EL.U/mL), as assessed by the Enzyme-Linked Immunosorbent Assay (ELISA).|At one month post dose 3 [PIII(M4)]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.||Subjects|||Number
710241|NCT00158756|Secondary|Number of Seroprotected Subjects for Anti-Hepatitis B (Anti-HBs) Antibodies|A seroprotected subject was defined as a vaccinated subject with antibody concentrations ≥ 10 milli-international units per millilitre (mIU/mL).|At one most post dose 3 [PIII(M4)]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.||Subjects|||Number
710242|NCT00158756|Secondary|Number of Seroprotected Subjects for Anti-DT Antibodies as Assessed by ELISA|A seroprotected subject is a vaccinated subject with concentrations ≥ 0.1 IU/mL.|At one month post dose 3 [PIII(M4)]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.||Subjects|||Number
710243|NCT00158756|Primary|Seroprotection Status for Anti-diphteria (Anti-DT) Antibodies|Seroprotection status (SP) defined vaccinated subjects with antibody concentrations greater than or equal to (≥) 0.1 international units per millitre (IU/mL) as assessed by the Enzyme-linked Immunosorbent Assay (ELISA) or ≥ 0.016 IU/mL by neautralization assay on Vero cells in subjects seronegative for ELISA.|At one month post dose 3 [PIII(M4)]|The analysis were performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.||IU/mL||95% Confidence Interval|Geometric Mean
710244|NCT00158925|Secondary|Lead Implant Time|The estimated target value for average implant time is 30 minutes. Unit of measure will be the time period needed for the implant.|Implant|Although 96 subjects were implanted/attempted, lead implant time was only collected for 69 subjects.||h.min||Standard Deviation|Mean
710245|NCT00158925|Primary|Lead-related Complication-free Rate at 3 Months|The estimated target value for this endpoint is 80%.|3 months|||% of complication free-rate||95% Confidence Interval|Mean
710246|NCT00158925|Primary|Chronic Sensing Amplitudes at 3 Months|The expected mean is 10mV.|3 months|Although 96 subjects were implanted/attempted, for 67 subjects still in follow up at the end of the 3M fu period, chronic sensing amplitude was measured.||mV||Standard Deviation|Mean
710247|NCT00158925|Primary|Chronic Pacing Impedances at 3 Months|The expected mean impedance is 500 Ohms.|3 months|Although 96 subjects were implanted/attempted, for 80 subjects still in follow up at the end of the 3M fu period, the mean impedance was measured.||Ohms||Standard Deviation|Mean
710248|NCT00158925|Primary|Chronic Pacing Thresholds at 3 Months|The expected mean pacing threshold is 1.9V at 0.5 ms pulse width.|3 months|Although 96 subjects were implanted/attempted, for 80 subjects still in follow up at the end of the 3M fu periodm the mean pacing threshold was obtained.||V||Standard Deviation|Mean
710249|NCT00159419|Primary|Bone Mineral Density|"By Dual-energy x-ray absorptiometry. Results were reported as z-scores as well as as absolute values. The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. Higher Z scores indicate a better outcome, or similar, as accurate and appropriate."|2 years|||z-score||Standard Deviation|Mean
710250|NCT00159432|Secondary|Number of Participants With Grade 3 or Higher Toxicity|Summary of grade 3 (per CTCAE v3.0) or higher toxicities which generally is described as a severe adverse reaction or symptom.|Baseline, every 2 weeks of each cycle, and at end of treatment, up to 18 months.|All enrolled participants who receive the first course of treatment are included in the analysis as per protocol.||Participants|||Number
710251|NCT00159432|Primary|Median Time for Progression Free Survival|Progression-free survival was measured from the start of treatment until the time the subject is first recorded as having disease progression (progression = 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed or baseline, progression of non-measurable disease in the opinion of treating physician, appearance of new lesion/site, death due to disease), or death due to any cause. If a subject has not progressed or died, progression-free survival was censored at the time of last follow-up or the start of another treatment, whichever came first.|Up to 6 years|All enrolled participants who receive the first course of treatment are included in the analysis as per protocol.||Months||95% Confidence Interval|Median
710252|NCT00152763|Secondary|Percentage of Participants Who Received ICD Therapies|Percentage of participants who received ICD shocks or anti-tachycardia therapies, data extracted from participants ICD devices over follow-up.|12-months follow-up|||Percentage of participants|||Number
710253|NCT00152763|Secondary|SF-36 Physical Component Summary Score at 12-months Follow-up|Quality of life measure of physical health, scores range from 0 to 100 with higher scores representing better physical health.|Twelve-months follow-up|||units on a scale||Standard Deviation|Mean
710254|NCT00152763|Secondary|SF-36 Physical Component Summary Score at 6-months Follow-up|Quality of life measure of physical health, scores range from 0 to 100 with higher scores representing better physical health.|Six-months follow-up|||units on a scale||Standard Deviation|Mean
710255|NCT00152763|Secondary|SF-36 Physical Component Summary Score at Baseline|Quality of life measure of physical health, scores range from 0 to 100 with higher scores representing better physical health.|Baseline|||units on a scale||Standard Deviation|Mean
710256|NCT00152763|Primary|Crown-Crisp Experiential Index - Phobic Anxiety Scale at 12-months Follow-up|Psychometric measure of phobic anxiety, scores range from 1 to 3. Higher scores represent greater phobic anxiety symptoms.|Twelve-months follow-up|||units on a scale||Standard Deviation|Mean
710257|NCT00152763|Primary|Crown-Crisp Experiential Index - Phobic Anxiety Scale at 6-months Follow-up|Psychometric measure of phobic anxiety, scores range from 1 to 3. Higher scores represent greater phobic anxiety symptoms.|Six-months follow-up|||units on a scale||Standard Deviation|Mean
710258|NCT00152763|Primary|Crown-Crisp Experiential Index - Phobic Anxiety Scale at Baseline|Psychometric measure of phobic anxiety, scores range from 1 to 3. Higher scores represent greater phobic anxiety symptoms.|Baseline|||units on a scale||Standard Deviation|Mean
710259|NCT00152763|Primary|Impact of Event Scale-Revised Hyperarousal Scale at 12-months Follow-up|Psychometric measure of post traumatic stress disorder hyper-arousal symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder hyperarousal symptoms.|Twelve-months follow-up|||units on a scale||Standard Deviation|Mean
710260|NCT00152763|Primary|Impact of Event Scale-Revised Hyperarousal Scale at 6-months Follow-up|Psychometric measure of post traumatic stress disorder hyper-arousal symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder hyperarousal symptoms.|Six-months follow-up|||units on a scale||Standard Deviation|Mean
710261|NCT00152763|Primary|Impact of Event Scale-Revised Hyperarousal Scale at Baseline|Psychometric measure of post traumatic stress disorder hyper-arousal symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder hyperarousal symptoms.|Baseline|||units on a scale||Standard Deviation|Mean
710262|NCT00152763|Primary|Impact of Events Scale-Revised - Avoidance Scale at 12-months Follow-up|Psychometric assessment of post traumatic stress disorder avoidance symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder avoidance symptoms.|Twelve-months follow-up|Intention to treat analysis although data from participants who died were omitted from analysis||units on a scale||Standard Deviation|Mean
710265|NCT00152763|Primary|Impact of Events Scale-Revised - Intrusiveness Scale at 12-months Follow-up|Psychometric measure of post traumatic stress disorder intrusiveness symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder intrusiveness symptoms.|Twelve-months follow-up|||units on a scale||Standard Deviation|Mean
710266|NCT00152763|Primary|Impact of Events Scale-Revised - Intrusiveness Scale at 6-months Follow-up|Psychometric measure of post traumatic stress disorder intrusiveness symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder intrusiveness symptoms.|Six-months follow-up|||units on a scale||Standard Deviation|Mean
710267|NCT00152763|Primary|Impact of Events Scale-Revised - Intrusiveness Scale at Baseline|Psychometric measure of post traumatic stress disorder intrusiveness symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder intrusiveness symptoms.|Baseline|||units on a scale||Standard Deviation|Mean
710268|NCT00152763|Primary|Impact of Events Scale-Revised - Total Score at 12-months Follow-up|Psychometric measure of post traumatic stress disorder symptoms, scores range from 0 to 4. A score threshold of 1.4 has been found to diagnostic of post traumatic stress disorder in war veterans. Higher scores represent greater total post traumatic stress disorder symptoms.|Twelve-months follow-up|Intention to treat analysis although data for participants who died over follow-up were omitted.||units on a scale||Standard Deviation|Mean
710269|NCT00152763|Primary|Impact of Events Scale-Revised - Total Score at 6-months Follow-up|Psychometric measure of post traumatic stress disorder symptoms, scores range from 0 to 4. A score threshold of 1.4 has been found to diagnostic of post traumatic stress disorder in war veterans. Higher scores represent greater total post traumatic stress disorder symptoms.|Six-months follow-up|Intention to treat analysis although data for participants who died over follow-up were omitted.||units on a scale||Standard Deviation|Mean
710270|NCT00152763|Secondary|SF-36 Mental Component Summary Scale at 12-months Follow-up|Quality of life measure - mental health summary, scores range from 0 to 100 with higher scores representing better mental health.|Twelve-months follow-up|||units on a scale||Standard Deviation|Mean
710271|NCT00152763|Primary|Impact of Events Scale-Revised - Total Score at Baseline|Psychometric measure of post traumatic stress disorder symptoms, scores range from 0 to 4. A score threshold of 1.4 has been found to diagnostic of post traumatic stress disorder in war veterans. Higher scores represent greater total post traumatic stress disorder symptoms.|Baseline|Intention to treat analysis although data for participants who died over follow-up were omitted.||units on a scale||Standard Deviation|Mean
710272|NCT00152763|Primary|Hospital Anxiety and Depression Scale - Anxiety Scale at 12-months Follow-up|Psychometric scale measuring symptoms of anxiety,score range is 0 to 24. Scores >= 8 represent clinically elevated scores. Higher scores represent greater anxiety symptoms.|Twelve-months follow-up|Intention to treat analyses but data on participants who died over follow-up were omitted.||units on a scale||Standard Deviation|Mean
710273|NCT00152763|Primary|Hospital Anxiety and Depression Scale - Anxiety Scale at 6-months Follow-up|Psychometric scale measuring symptoms of anxiety,score range is 0 to 24. Scores >= 8 represent clinically elevated scores. Higher scores represent greater anxiety symptoms.|Six-months follow-up|Intention to treat analyses but data on participants who died over follow-up were omitted.||units on a scale||Standard Deviation|Mean
710274|NCT00152763|Primary|Hospital Anxiety and Depression Scale - Anxiety Scale at Baseline|Psychometric scale measuring symptoms of anxiety,score range is 0 to 24. Scores >= 8 represent clinically elevated scores. Higher scores represent greater anxiety symptoms.|Baseline|Intention to treat analyses but data on participants who died over follow-up were omitted.||units on a scale||Standard Deviation|Mean
710275|NCT00152763|Primary|Hospital Anxiety and Depression Scale - Depression Scale at 12-months Follow-up|Psychometric scale measuring symptoms of depression, score range is 0 to 24. Scores >= 8 represent clinically elevated scores. Higher scores represent greater depressive symptoms.|Twelve-months follow-up|Intention to treat analyses but data on participants who died over follow-up were omitted.||units on a scale||Standard Deviation|Mean
710276|NCT00152763|Secondary|SF-36 Mental Component Summary Scale at 6-months Follow-up|Quality of life measure - mental health summary, scores range from 0 to 100 with higher scores representing better mental health.|Six-months follow-up|||units on a scale||Standard Deviation|Mean
710277|NCT00152763|Primary|Hospital Anxiety and Depression Scale - Depression Scale at 6-months Follow-up|Psychometric scale measuring symptoms of depression, score range is 0 to 24. Scores >= 8 represent clinically elevated scores. Higher scores represent greater depressive symptoms.|Six-months follow-up|Intention to treat analyses but data on participants who died over follow-up were omitted.||units on a scale||Standard Deviation|Mean
710278|NCT00152763|Secondary|SF-36 Mental Component Summary Scale at Baseline|Quality of life measure - mental health summary, scores range from 0 to 100 with higher scores representing better mental health.|Baseline|||units on a scale||Standard Deviation|Mean
710279|NCT00152763|Primary|Hospital Anxiety and Depression Scale - Depression Scale at Baseline|Psychometric scale measuring symptoms of depression, score range is 0 to 24. Scores >= 8 represent clinically elevated scores. Higher scores represent greater depressive symptoms.|Baseline|Intention to treat analyses but data on participants who died over follow-up were omitted.||units on a scale||Standard Deviation|Mean
710280|NCT00152971|Secondary|Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period|"Major bleeding events were defined as
fatal
clinically overt associated with loss of haemoglobin >=20g/L in excess of what was expected
clinically overt leading to the transfusion of >=2 units packed cells or whole blood in excess of what was expected
symptomatic retroperitoneal, intracranial, intraocular or intraspinal
requiring treatment cessation
leading to re-operation
Clinically-relevant was defined as
spontaneous skin hematoma greater than or equal to 25 cm²
wound hematoma greater than or equal to 100 cm²
spontaneous nose bleed lasting longer than 5 min
macroscopic hematuria spontaneous or lasting longer than 24 hours if associated with an intervention
spontaneous rectal bleeding (more than a spot on toilet paper)
gingival bleeding lasting longer than 5 min
any other bleeding event considered clinically relevant by the investigator
Minor bleeding events were defined as all other bleeding events that did not fulfil the criteria from above."|First administration until 12-15 days|Treated set||Participants|||Number
710315|NCT00153101|Secondary|ONTARGET. Newly Diagnosed Congestive Heart Failure|The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to the first event analysis of the endpoint Newly diagnosed Congestive Heart failure.|56 months|FAS of the ONTARGET trial||participants|||Number
710281|NCT00152971|Secondary|Number of Participants With Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period|Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine bilateral venography), symptomatic DVT (confirmed by venous compression ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy).|3 months|Patients with any data available during follow-up||Participants|||Number
710282|NCT00152971|Secondary|Number of Participants Who Died During Treatment Period|All cause death, as adjudicated by the VTE events committee|First administration until 12-15 days|Full Analysis Set - op||Participants|||Number
710283|NCT00152971|Secondary|Number of Participants With Pulmonary Embolism During Treatment Period|Pulmonary embolism confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy, and as adjudicated by the VTE events committee|First administration until 12-15 days|Full Analysis Set - op||Participants|||Number
710284|NCT00152971|Secondary|Number of Participants With Symptomatic Deep Vein Thrombosis During Treatment Period|Symptomatic Deep Vein Thrombosis, confirmed by venous compression ultrasound, venography or autopsy, and as adjudicated by the VTE events committee|First administration until 12-15 days|Full Analysis Set - op (all patients who are treated and operated)||Participants|||Number
710285|NCT00152971|Secondary|Number of Participants With Total Deep Vein Thrombosis During Treatment Period|Total Deep Vein Thrombosis as adjudicated by the VTE events committee|First administration until 12-15 days|Full Analysis Set - tDVT (all patients who had surgery and were randomised, received treatment, had an evaluable venogram, or had confirmed symptomatic Deep Vein Thrombosis)||Participants|||Number
710286|NCT00152971|Secondary|Number of Participants With Proximal Deep Vein Thrombosis During Treatment Period|Proximal Deep Vein Thrombosis as adjudicated by the VTE events committee|First administration until 12-15 days|Full Analysis Set - pDVT (all patients who had surgery and were randomised, received treatment, had an evaluable venogram for proximal Deep Vein Thrombosis, or had confirmed symptomatic Deep Vein Thrombosis)||Participants|||Number
710287|NCT00152971|Secondary|Number of Participants With Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period|Major Venous Thromboembolic Event (VTE) is defined as proximal DVT and PE, as adjudicated by the VTE events committee|First administration until 12-15 days|Full Analysis Set - major (all patients who had surgery and were randomised, received treatment, had an evaluable venogram for proximal Deep Vein Thrombosis, or had confirmed symptomatic Deep Vein Thrombosis, Pulmonary Embolism, or had died by a Venous Thromboembolic Event-related death)||Participants|||Number
710288|NCT00152971|Primary|Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period|"Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine bilateral venography), symptomatic DVT (confirmed by venous compression ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy).
All of these components and all deaths were centrally adjudicated by the VTE events committee, which was not aware of the treatment allocation of the patients."|First administration until 12-15 days|Full Analysis Set (all patients who had surgery and were randomised, received treatment, had an evaluable venogram for distal and proximal Deep Vein Thrombosis, or had confirmed symptomatic Deep Vein Thrombosis, Pulmonary Embolism, or had died)||Participants|||Number
710289|NCT00153062|Primary|Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Telmisartan vs. Placebo Only)||time since randomization; follow-up period is 1.5 to 4.4 years|||Participants|||Number
710290|NCT00153062|Secondary|Number of Patients With New Onset of Diabetes (Telmisartan vs. Placebo Only)||Randomization to final patient contact|Patients who did not have diabetes mellitus at baseline were analyzed as randomized and were included in the analysis until final patient contact regardless of whether they were still on treatment.||Participants|||Number
710291|NCT00153062|Secondary|Composite Outcome of Stroke, Myocardial Infarction, Vascular Death, or New or Worsening Congestive Heart Failure (CHF) (Telmisartan vs. Placebo Only)|Number of patients with any of stroke, myocardial infarction, vascular death, or new or worsening congestive heart failure|time since randomization; follow-up period is 1.5 to 4.4 years|Patients were analyzed as randomized and were included in the analysis until final patient contact regardless of whether they were still on treatment.||Participants|||Number
710292|NCT00153062|Secondary|Composite Outcome of Stroke, Myocardial Infarction (MI), or Vascular Death (Antiplatelet Comparison Only)|Number of patients with any of stroke, myocardial infarction, vascular death|time since randomization; follow-up period is 1.5 to 4.4 years|Patients were analyzed as randomized and were included in the analysis until final patient contact regardless of whether they were still on treatment.||Participants|||Number
710293|NCT00153062|Primary|Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Antiplatelet Comparison Only)||time since randomization; follow-up period is 1.5 to 4.4 years|Patients were analyzed as randomized and were included in the analysis until final patient contact regardless of whether they were still on treatment.||Participants|||Number
710294|NCT00153101|Secondary|TRANSCEND. Newly Diagnosed Congestive Heart Failure|Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND).|56 months|FAS of the TRANSCEND trial||participants|||Number
710295|NCT00153101|Secondary|TRANSCEND. Cardiovascular Revascularization Procedure|Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND).|56 months|FAS of the TRANSCEND trial||participants|||Number
710296|NCT00153101|Secondary|TRANSCEND. Newly Diagnosed Diabetes|Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND). Time to the first event analysis of the endpoint Newly diagnosed Diabetes. Only calculated for those patients without diabetes at baseline.|56 months|Only for patients of TRANSCEND trial treated with Telmisartan 80mg or Telmisartan 80mg placebo daily for 56 months without diabetes at baseline.||participants|||Number
710316|NCT00153101|Secondary|ONTARGET. Normalisation From Micro- or Macroalbuminuria to Normoalbuminuria|ONTARGET. Nephropathy subcategory: Normalisation from micro- or macroalbuminuria to normoalbuminuria. Normalisation from micro- or macroalbuminuria to normoalbuminuria is defined as UACR <30 mg/g Crea in patients with a UACR ≥30 mg/g Crea at baseline.|56 months|FAS of the ONTARGET trial||participants|||Number
710297|NCT00153101|Secondary|TRANSCEND. Cognitive Decline|Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND). Time to first event analysis of the endpoint cognitive decline i.e. Comparison of the Mini mental state Evaluation (MMSE) of patients at baseline with that at the 2years and end of trial. A decrease in MMSE from baseline represents a cognitive decline. This outcome measure is only available for those patients who had MMSE at baseline.|56 months|Only patients of the TRANSCEND trial treated with Telmisartan 80mg or telmisartan 80mg placebo daily for 56 months with Mini mental state evaluation (MMSE) at baseline.||participants|||Number
710298|NCT00153101|Secondary|TRANSCEND. New Onset of Atrial Fibrillation|Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND).|56 months|FAS of the TRANSCEND trial||participants|||Number
710299|NCT00153101|Secondary|TRANSCEND. Normalisation From Micro- or Macroalbuminuria to Normoalbuminuria|TRANSCEND. Nephropathy subcategory: Normalisation from micro- or macroalbuminuria to normoalbuminuria. Normalisation from micro- or macroalbuminuria to normoalbuminuria is defined as UACR <30 mg/g Crea in patients with a UACR ≥30 mg/g Crea at baseline.|56 months|FAS of the TRANSCEND trial||participants|||Number
710300|NCT00153101|Secondary|TRANSCEND. Combined Endpoint of Doubling Serum Creatinine, Progression to ESRD, New Microalbuminuria or New Macroalbuminuria|TRANSCEND. Nephropathy subcategory: Combined endpoint of doubling serum creatinine, progression to ESRD, new microalbuminuria or new macroalbuminuria|56 months|FAS of the TRANSCEND trial||participants|||Number
710301|NCT00153101|Secondary|TRANSCEND. New Macroalbuminuria|TRANSCEND. Nephropathy subcategory: New macroalbuminuria. New macroalbuminuria is defined as UACR ≥300 mg/g creatinine [Crea] in patients with a UACR <300 mg/g Crea at baseline|56 months|FAS of the TRANSCEND trial||participants|||Number
710302|NCT00153101|Secondary|TRANSCEND. New Microalbuminuria|TRANSCEND. Nephropathy subcategory: New microalbuminuria. New microalbuminuria is defined as UACR ≥30 mg/g creatinine [Crea] in patients with a UACR <30 mg/g Crea at baseline|56 months|FAS of the TRANSCEND trial||participants|||Number
710303|NCT00153101|Secondary|TRANSCEND. Progression to ESRD|TRANSCEND. Nephropathy subcategory: Progression to ESRD. Progression to ESRD is defined as initiation of dialysis, need for renal transplantation, or eGFR <15 mL/min/1.73m²|56 months|FAS of the TRANSCEND trial||participants|||Number
710304|NCT00153101|Secondary|TRANSCEND. Doubling of Serum Creatinine|TRANSCEND. Nephropathy subcategory: doubling of serum creatinine|56 months|FAS of the TRANSCEND trial||participants|||Number
710305|NCT00153101|Secondary|TRANSCEND. Hospitalization for Congestive Heart Failure|Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND).|56 months|FAS of the TRANSCEND trial||participants|||Number
710306|NCT00153101|Secondary|TRANSCEND. Non-fatal Stroke|Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND).|56 months|FAS of the TRANSCEND trial||participants|||Number
710307|NCT00153101|Secondary|TRANSCEND. Non-fatal Myocardial Infarction|Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND). Time to the first event analysis of the endpoint non-fatal myocardial infarction.|56 months|FAS of the TRANSCEND trial||participants|||Number
710308|NCT00153101|Secondary|TRANSCEND. Cardiovascular Death|Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND). Time to the first event analysis of the endpoint cardiovascular death.|56 months|FAS of the TRANSCEND trial||participants|||Number
710309|NCT00153101|Primary|TRANSCEND. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure|Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND). Time to first event analysis of the following defined endpoints, Cardiovascular Death, Non-fatal myocardial infarction, non-fatal stroke and hospitalization for congestive heart failure.|56 months|FAS of the TRANSCEND trial||participants|||Number
710310|NCT00153101|Secondary|TRANSCEND. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke|Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND). Time to first event analysis of the following defined endpoints, Cardiovascular Death, Non-fatal myocardial infarction, non-fatal stroke and hospitalization for congestive heart failure.|56 months|FAS of the TRANSCEND trial||participants|||Number
710311|NCT00153101|Secondary|ONTARGET. New Onset of Atrial Fibrillation|The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to first event analysis of endpoint new onset of atrial fibrillation.|56 months|Only patients of the ONTARGET trial treated with Telmisartan 80mg/ramipril 10mg or Telmisartan 80mg/Ramipril 10mg placebo or Ramipril 10mg/ telmisartan 80mg placebo daily for 56 months without atrial fibrillation at baseline.||participants|||Number
710312|NCT00153101|Secondary|ONTARGET. Cognitive Decline|The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to first event analysis of the endpoint cognitive decline i.e. Comparison of the Mini mental state Evaluation (MMSE) of patients at baseline with that at the 2years and end of trial. A decrease in MMSE from baseline represents a cognitive decline. This outcome measure is only available for those patients who had MMSE at baseline.|56 months|Only patients of the ONTARGET trial treated with Telmisartan 80mg/ramipril 10mg or Telmisartan 80mg/Ramipril 10mg placebo or Ramipril 10mg/ telmisartan 80mg placebo daily for 56 months with Mini mental state evaluation (MMSE) at baseline.||participants|||Number
710313|NCT00153101|Secondary|ONTARGET. Newly Diagnosed Diabetes|The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to the first event analysis of the endpoint Newly diagnosed Diabetes. Only calculated for those patients without diabetes at baseline.|56 months|Only patients of the ONTARGET trial treated with Telmisartan 80mg/ramipril 10mg or Telmisartan 80mg/Ramipril 10mg placebo or Ramipril 10mg/ telmisartan 80mg placebo daily for 56 months without baseline diabetes.||participants|||Number
710314|NCT00153101|Secondary|ONTARGET. Cardiovascular Revascularization Procedure|The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET).|56 months|FAS of the ONTARGET trial||participants|||Number
710334|NCT00153179|Primary|Difference in Insulin-mediated Skeletal Muscle Glucose Utilization Between Test Agent and Placebo||7 days||||||
710317|NCT00153101|Secondary|ONTARGET. Combined Endpoint of Doubling of Serum Creatinine, Progression to ESRD, New Microalbuminuria, or New Macroalbuminuria|ONTARGET. Nephropathy subcategory: Combined endpoint of doubling of serum creatinine, progression to ESRD, new microalbuminuria, or new macroalbuminuria|56 months|FAS of the ONTARGET trial||participants|||Number
710318|NCT00153101|Secondary|ONTARGET. New Macroalbuminuria|ONTARGET. Nephropathy subcategory: New macroalbuminuria. New macroalbuminuria is defined as Urinary Albumin Creatinine Ratio ≥300 mg/g Crea in patients with a Urinary Albumin Creatinine Ratio <300 mg/g Crea at baseline.|56 months|FAS of the ONTARGET trial||participants|||Number
710319|NCT00153101|Secondary|ONTARGET. New Microalbuminuria|ONTARGET. Nephropathy subcategory: New microalbuminuria. New microalbuminuria is defined as Urinary Albumin Creatinine Ratio ≥30 mg/g Crea in patients with a Urinary Albumin Creatinine Ratio <30 mg/g Crea at baseline.|56 months|FAS of the ONTARGET trial||participants|||Number
710320|NCT00153101|Primary|ONTARGET. 3-fold Composite Endpoint of Doubling of Serum Creatinine, Progression to End Stage Renal Disease (ESRD) and All-cause Mortality in Diabetic Nephropathy Patients|"ESRD is defined by initiation of dialysis, need for renal transplantation, or eGFR <15 mL/min/1.73 m². Diabetic nephropathy patients are diabetic patients with macro-albuminuria assessed as a Urinary Albumin Creatinine Ratio (UACR) ≥300 mg/g Crea at baseline.
These renal outcomes were not adjudicated (apart from death)."|56 months|Subset of the Full Analysis Set (FAS [DN]) consisting of all randomised patients with diabetic nephropathy (UACR ≥300 mg/g Crea) of the ONTARGET trial.||participants|||Number
710321|NCT00153101|Secondary|ONTARGET. Progression to ESRD|ONTARGET. Nephropathy subcategory: Progression to ESRD. Progression to ESRD is defined as initiation of dialysis, need for renal transplantation, or eGFR <15 mL/min/1.73 m².|56 months|FAS of the ONTARGET trial||participants|||Number
710322|NCT00153101|Secondary|ONTARGET. Doubling of Serum Creatinine|ONTARGET. Nephropathy subcategory: doubling of serum creatinine|56 months|FAS of the ONTARGET trial||participants|||Number
710323|NCT00153101|Secondary|ONTARGET. All-cause Mortality in Diabetic Nephropathy Patients|Diabetic nephropathy patients are diabetic patients with macro-albuminuria assessed as a Urinary Albumin Creatinine Ratio (UACR) ≥300 mg/g Crea at baseline.|56 months|FAS [DN] of the ONTARGET trial||participants|||Number
710324|NCT00153101|Secondary|ONTARGET. Progression to End Stage Renal Disease (ESRD) in Diabetic Nephropathy Patients|ESRD is defined by initiation of dialysis, need for renal transplantation, or eGFR <15 mL/min/1.73 m². Diabetic nephropathy patients are diabetic patients with macro-albuminuria assessed as a Urinary Albumin Creatinine Ratio (UACR) ≥300 mg/g Crea at baseline.|56 months|FAS [DN] of the ONTARGET trial||participants|||Number
710325|NCT00153101|Secondary|ONTARGET. Doubling of Serum Creatinine in Diabetic Nephropathy Patients|Diabetic nephropathy patients are diabetic patients with macro-albuminuria assessed as a Urinary Albumin Creatinine Ratio (UACR) ≥300 mg/g Crea at baseline.|56 months|FAS [DN] of the ONTARGET trial||participants|||Number
710326|NCT00153101|Secondary|ONTARGET. Hospitalization for Congestive Heart Failure|The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to the first event analysis of the endpoint hospitalization for congestive heart failure.|56 months|FAS of the ONTARGET trial||participants|||Number
710327|NCT00153101|Secondary|ONTARGET. Non-fatal Stroke|The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to first event analysis of the endpoint non-fatal stroke.|56 months|FAS of the ONTARGET trial||participants|||Number
710328|NCT00153101|Secondary|ONTARGET. Non-fatal Myocardial Infarction|The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to the first event analysis of the endpoint non-fatal myocardial infarction.|56 months|FAS of the ONTARGET trial||participants|||Number
710329|NCT00153101|Secondary|ONTARGET. Cardiovascular Death|The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to the first event analysis of the endpoint cardiovascular death.|56 months|FAS of the ONTARGET trial||participants|||Number
710330|NCT00153101|Secondary|ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke|The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to first event analysis of the following defined endpoints, non-fatal myocardial infarction or non-fatal stroke|56 months|FAS of the ONTARGET trial||participants|||Number
710331|NCT00153101|Primary|ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure|The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to first event analysis of the following defined endpoints, Cardiovascular Death, Non-fatal myocardial infarction, non-fatal stroke and hospitalization for congestive heart failure.|56 months|FAS of the ONTARGET trial||participants|||Number
710332|NCT00153166|Secondary|'M' = Whole Body Insulin Sensitivity|A hyperinsulinemic-euglycemic clamp was performed prior to and during FDG-PET imaging to measure insulin sensitivity and to standardize metabolic conditions. Subjects were required to fast for 8 hours prior to the study. Patients were given a primed insulin infusion of 2 mU/kg/min. Serum glucose measurements were made at five-minute intervals from an arterialized venous sample achieved by placing the hand in a warming box at 50°C. Blood glucose levels are checked every 5 minutes and 20% dextrose infusion is adjusted to maintain a serum glucose level of approximately 80 mg/dL. Subjects were considered to have achieved steady state when the dextrose infusion rate required to maintain a serum glucose level of 80 mg/dL varied by no greater than 5%. To compute the steady-state glucose disposal rate, we averaged the glucose infusion rates over the last 20 minutes of the clamp and applied a “space correction” to account for small changes in serum glucose levels over that time period.|every 5 minutes for 20 minutes|Baseline Characteristics were collected according to the clinical diagnosis of the patients and not according to randomization. Participants were grouped at Baseline and are presented here irrespective of randomization because the primary intention was to compare the different types of patients regardless of interventions received.||mg/kg/min||Inter-Quartile Range|Median
710333|NCT00153166|Primary|Lower Extremity Skeletal Muscle Glucose Uptake|Net calf skeletal muscle glucose uptake determined by Patlak modeling.|60 minutes|Baseline Characteristics were collected according to the clinical diagnosis of the patients and not according to randomization. Participants were grouped at Baseline and are presented here irrespective of randomization because the primary intention was to compare the different types of patients regardless of interventions received.||umol/kg/min||Standard Deviation|Mean
710336|NCT00153179|Primary|Flow-mediated Dilation After Placebo or Acipimox Treatment Between Healthy Controls and Those With Metabolic Syndrome|Flow mediated dilation is calculated as follows: A resting arterial diameter measurement is obtained using the average of 10 EKG-gated ultrasound images. Next, an occlusive pressure is applied (using a blood pressure cuff inflated to a suprasystolic pressure)for a period of 5 minutes. After 5 minutes, the cuff is rapidly deflated. This produces a reactive hyperemic response which is captured via ultrasound at 1 minute post cuff deflation (also 10 EKG-gated images averaged). The diameter of the artery following reactive hyperemia is calculated and compared to the resting diameter to obtain a percent dilation. This is flow-mediated dilation.|7 days|||Flow mediated dilation||Standard Deviation|Mean
710337|NCT00159783|Primary|Number of Participants With Laboratory Values Outside Normal Range|"Normal ranges were provided by the central laboratory.
Biochemistry = electrolytes, creatine kinase, liver enzymes, blood urea nitrogen, creatinine, alkaline phosphatase, protein, albumin
Metabolic chemistry = cholesterol, glucose, triglycerides, glycosylated hemoglobin
Endocrinology/miscellaneous = insulin, prolactin
Hematology = hemoglobin, red blood cell count, white blood cell count, platelets, hematocrit, neutrophils, lymphocytes, monocytes, eosinophils, basophils"|Week 40 or endpoint|"Number at risk = participants with either normal or abnormal baseline value and a non-missing value at endpoint.
Actual at risk: 20-32 for placebo/asenapine arm; 50-78 for asenapine arm; 63-106 in olanzapine arm."||Participants|||Number
710338|NCT00159783|Primary|Number of Participants With Markedly Abnormal Vital Sign Changes|"Vital signs measured: sitting blood pressure, heart rate.
Definitions:
Markedly abnormal decreases: heart rate (HR) – if ≤50 bpm and decrease from baseline of ≥15 beats per minute (bpm); systolic blood pressure (SBP) – if ≤90 mm Hg and decrease from baseline of ≥20 mm Hg; diastolic blood pressure (DBP) – if ≤50 mm Hg and decrease from baseline of ≥15 mm Hg.
Markedly abnormal increases: HR – if ≥110 bpm and increase from baseline of ≥15 bpm; SBP – if ≥180 mm Hg and increase from baseline of ≥20 mm Hg; DBP – if ≥105 mm Hg and increase from baseline of ≥15 mm Hg."|Post-baseline (at Week 4, 12, 20, 28, and 40 or endpoint)|||Participants|||Number
710339|NCT00159783|Primary|Abdominal Girth|Change in abdominal girth from baseline|Baseline to Week 40 or endpoint|||Centimeters (cm)||Standard Deviation|Mean
710340|NCT00159783|Primary|Concomitant Medications|"Concomitant medications are any medications taken on or after the date of first dose of double-blind study drug through the date of
last dose of double-blind study drug."|Up to 40 weeks|||Participants|||Number
710341|NCT00159783|Primary|Extrapyramidal Symptoms [EPS]|"EPS was assessed using the (1) involuntary movement scale [AIMS], (2) Barnes Akathisia Rating Scale [BARS], and (3) Simpson Angus Rating Scale SARS.
AIMS score range 0-4; higher scores indicate greater symptom severity.
BARS score rang 0-9; higher scores indicate greater severity of akathisia.
SARS score range 0-40; higher scores indicate greater degree of Parkinsonism."|Week 40 or endpoint|||Units on a scale||Standard Deviation|Mean
710342|NCT00159783|Primary|Body Weight|Weight change from baseline|Baseline to Week 40 or endpoint|||Kilograms||Standard Deviation|Mean
710343|NCT00159783|Primary|Number of Participants With Abnormal Electrocardiogram|This is the number of participants with electrocardiogram (ECG) adverse events.|Week 40 or endpoint|||Participants|||Number
710344|NCT00159783|Primary|Number of Participants With Abnormal Physical Examination Findings|Physical exam (PE) included assessment of general appearance, skin, head, eyes, ears, nose, throat, lungs, blood pressure, cardiac rhythm & rate, neurologic status, and abdomen. The findings were deemed to be normal/abnormal based on the clinical judgment of the investigator.|Week 40 or endpoint|||Participants|||Number
710345|NCT00159783|Primary|Participants Who Experienced Adverse Event(s)|"Adverse event (AE) data, both serious and non-serious, were collected. Serious AEs were also collected up to 30 days post last dose of study drug.
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product. It does not necessarily have to have a causal relationship with this treatment.
An AE is defined as serious if it results in death, is life-threatening, requires in-patient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect."|Up to 40 weeks|||Participants|||Number
710346|NCT00159822|Secondary|Number of Subjects With Complete or Partial Serological Response|Serological response: normalization (complete response) defined as return to normal values (≤ 1 arc); partial response defined as significant decrease but not complete (decrease of 2 or more arcs compared to baseline). Complete or partial response summarized as Improvement; based on arc values at visit compared to arc values at baseline (inclusion).|Month 3, and Month 6, Month 9, or Month 12 [EOT]|mITT (with serology at inclusion); 6, 9 or 12 months (in case of extension of the treatment period beyond 6 months) as EOT or last visit available. Data summarized as Worsening (failure), No change (stabilization), or Improvement (complete or partial response) due to large number of missing results values.||participants|||Number
710347|NCT00159822|Secondary|Number of Subjects With Mycological Response of Eradication|Mycological response: eradication: absence of aspergillus species (spp) in bronchopulmonary samples: sputum, bronchial aspirate or bronchoalveolar lavage (BAL) (negative direct examination [exam] and negative culture), and negative histological exam when available; persistence (no eradication): presence of aspergillus spp in any relevant bronchopulmonary samples. Not done (presumed eradication): case reviewed by DRC for any mycological exams not performed to assess if case should constitute presumed eradication (no sputum due to clinical improvement).|Month 3, and Month 6, Month 9, or Month 12 [EOT]|mITT; 6, 9 or 12 months (in case of extension of the treatment period beyond 6 months) as EOT or last visit available.||participants|||Number
710348|NCT00159822|Secondary|Number of Subjects With Complete or Partial Radiological Response|Radiological response: based on chest TDM except for tracheo-bronchialaspergillosis which was assessed by bronchoscopy. Complete response: resolution of all radiographic and or bronchoscopic abnormalities attributable to aspergillosis present at baseline; partial response: reduction in diameter ≥ 50% on chest TDM or regressed lesion on endoscopy witnessed by 2 different operators without any new lesion.|Month 3, and Month 6, Month 9, or Month 12 [EOT]|mITT; End of treatment (EOT) or at last visit available [LVA](EOT or LVA includes data from 6, 9 or 12 months in case of extension of the treatment period beyond 6 months).||participants|||Number
710690|NCT00159965|Secondary|Symptom Checklist 90 (SCL-90)|"The SCL-90 is a 90 item self-report clinical rating scale oriented toward symptomatic behavior of outpatients, assessing from 0 (not at all bothered) to 4 (extremely bothered). The highest possible overall score is 360 and relates to a worse outcome."|Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)|||Units on a scale||Standard Deviation|Mean
710349|NCT00159822|Secondary|Change From Baseline in Quality of Life (QOL): St. George's Hospital Respiratory Questionnaire|Subject administered questionnaire to measure improvement in QOL; 50 questions exploring 3 different areas: symptoms, impact on activity profile (activity), and impact on daily life (impacts). Each item in an area is weighted based on empirical data; scores range from lowest possible weight 0 to highest possible weight 100. Scores for each section and total score calculated using score calculation algorithms with higher scores indicating poor health. Change from baseline: mean of (value of scores on scale at treatment visit minus baseline value).|Baseline, Month 3, and Month 6, Month 9, or Month 12 [EOT], and EOS (EOT + 6 months)|mITT; 6, 9 or 12 months (in case of extension of the treatment period beyond 6 months) as EOT or last visit available; (n) = number of subjects with analyzable data at observation.||scores on scale||95% Confidence Interval|Mean
710350|NCT00159822|Secondary|Global Survival: Number of Subjects With an Outcome of Death|Number of subjects with an outcome of death (adverse event with a fatal outcome) through end of study.|Baseline through EOS (EOT + 6 months)|Safety population (SAF): all subjects who took at least 1 dose of voriconazole.||participants|||Number
710351|NCT00159822|Secondary|Time to Relapse After EOT|Time (months) to relapse: any proven reappearance of pulmonary aspergillosis during the follow-up period, following a successful global outcome at EOT, and defined as a deterioration of clinical signs and symptoms, confirmed radiologically (chest [TDM] and or endoscopy) and mycologically (histology and or culture and or serology).|During the 6 months following EOT (EOT + 3 months, EOT + 6 months)|mITT; due to the small number of radiological reappearance (4 subjects), no formal analysis of this endpoint was performed.||months|||Number
710352|NCT00159822|Secondary|Number of Subjects With Relapse|Relapse: any proven reappearance of pulmonary aspergillosis during the follow-up period, following a successful global outcome at EOT, and defined as a deterioration of clinical signs and symptoms, confirmed radiologically (chest [TDM] and or endoscopy) and mycologically (histology and or culture and or serology).|During the 6 months following EOT (EOT + 3 months, EOT + 6 months)|mITT; due to the small number of radiological reappearance (4 subjects), no formal analysis of this endpoint was performed.||participants|||Number
710353|NCT00159822|Secondary|Change From Baseline in Respiratory Clinical Signs and Symptoms on Visual Analog Scales (VAS)|Subject assessment of improvement of respiratory clinical signs and symptoms as indicated by the subject placing a mark on a 10 cm VAS scored 0 (better state of health) to 100 (poor state of health) for cough, dyspnea, sputum, hemoptysis, chest tightness, and nocturnal awakening. Change from baseline: mean of (value of scores on scale at treatment visit minus baseline value).|Baseline, Month 3, and Month 6, Month 9, or Month 12 [EOT], and End of study ([EOS] EOT + 6 months)|mITT; 6, 9 or 12 months (in case of extension of the treatment period beyond 6 months) as EOT or last visit available; (n) = number of subjects with analyzable data at observation. Subject may be represented in >1 category.||scores on scale||95% Confidence Interval|Mean
710354|NCT00159822|Secondary|Number of Subjects With Successful Global Outcome at 6 Months: Complex Aspergilloma|Successful global outcome: composite assessment of radiological and mycological responses; defined as complete or partial radiological response and mycological eradication (absence of aspergillus); no success=criteria not met. Assessment was determined by the Data Review Committee (DRC). Complete response: resolution of all radiographic and or bronchoscopic abnormalities attributable to the aspergillosis present at baseline; partial response: reduction in diameter ≥ 50% on chest tomodensitometry (TDM) or regressed lesion on endoscopy witnessed by 2 different operators without any new lesion.|at 6 months of treatment|mITT||paticipants|||Number
710355|NCT00159822|Secondary|Number of Subjects With Successful Global Outcome at 6 Months: Chronic Necrotizing Pulmonary Aspergillosis (CNPA) and Tracheo-bronchial Aspergillosis|Successful global outcome: composite assessment of radiological and mycological responses; defined as complete or partial radiological response and mycological eradication (absence of aspergillus); no success=criteria not met. Assessment was determined by the Data Review Committee (DRC). Complete response: resolution of all radiographic and or bronchoscopic abnormalities attributable to the aspergillosis present at baseline; partial response: reduction in diameter ≥ 50% on chest tomodensitometry (TDM) or regressed lesion on endoscopy witnessed by 2 different operators without any new lesion.|at 6 months of treatment|mITT||participants|||Number
710356|NCT00159822|Secondary|Number of Subjects With Successful Global Outcome at Month 3 and End of Treatment: Chronic Bronchopulmonary Aspergillosis|Successful global outcome: composite assessment of radiological and mycological responses; defined as complete (resolution of radiographic and or bronchoscopic abnormalities attributable to aspergillosis present at baseline) or partial (reduction in diameter ≥ 50 percent on chest TDM or regressed lesion on endoscopy witnessed by 2 different operators without any new lesion) radiological response and mycological eradication after 3 months of treatment and after 9 or 12 months (in case of extension of treatment period beyond 6 months); no success=criteria not met. Assessment determined by DRC.|Month 3 and End of Treatment (Month 9 or Month 12)|mITT; End of treatment (EOT) or at last visit available [LVA] (EOT or LVA includes data from 6, 9 or 12 months in case of extension of the treatment period beyond 6 months). Month 6 analysis is reported in the primary outcome measure.||participants|||Number
710357|NCT00159822|Primary|Number of Subjects With Successful Global Outcome at 6 Months: Chronic Bronchopulmonary Aspergillosis|Successful global outcome: composite assessment of radiological and mycological responses; defined as complete or partial radiological response and mycological eradication (absence of aspergillus); no success=criteria not met. Assessment was determined by the Data Review Committee (DRC). Complete response: resolution of radiographic and or bronchoscopic abnormalities attributable to aspergillosis present at baseline; partial response: reduction in diameter ≥ 50 percent on chest tomodensitometry (TDM) or regressed lesion on endoscopy witnessed by 2 different operators without any new lesion.|at 6 months of treatment|Modified Intent to Treat (mITT): all subjects in ITT population (took at least 1 dose of voriconazole and had at least 1 post-inclusion efficacy assessment) who had diagnosis of chronic bronchopulmonary aspergillosis confirmed by the Data Review Committee (DRC); 5 subjects excluded from mITT population due to unproven diagnosis.||participants|||Number
710358|NCT00160524|Secondary|Faecal Calprotectin Level at Week 258 Visit or (Early) Withdrawal Visit, if it is Earlier Than Week 258||Week 258 / (Early) Withdrawal Visit, if it is earlier than Week 258|Of the 594 subjects in the Intention-To-Treat (ITT) Population, 567 subjects are included in the analysis of this outcome measure. ITT Population includes all subjects of the Safety Population who provide at least one efficacy measurement after Week 0 of this study.||μg/g stool||95% Confidence Interval|Geometric Mean
710359|NCT00160524|Secondary|C-Reactive Protein (CRP) Level at Study Completion Visit or (Early) Withdrawal Visit||Study Completion Visit (Week 364) / (Early) Withdrawal Visit|Of the 594 subjects in the Intention-To-Treat (ITT) Population, 593 subjects are included in the analysis of this outcome measure. ITT Population includes all subjects of the Safety Population who provide at least one efficacy measurement after Week 0 of this study.||mg/L||95% Confidence Interval|Geometric Mean
710360|NCT00160524|Secondary|Percentage of Subjects With Positive Anti-CZP Anti-body Status at Any Time From Week 0 of the Feeder Study CDP870-031 or CDP870-032 to the Study Completion Visit in CDP870-033|Subjects are counted as antibody positive to Certolizumab Pegol if they have at least one positive result from Week 0 in one of the previous studies CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] to the Last Visit in this study. A positive result is defined as Anti-CZP antibody levels > 2.4 units/mL.|From Week 0 of study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] to Study Completion Visit (Week 364) of CDP870-033 (up to 90 months)|Of the 595 subjects in the Safety Population, 593 subjects are included in the analysis of this outcome measure. Safety Population includes all enrolled subjects who received at least one injection of study treatment in feeder study C87031 [NCT00152490] or C87032 [NCT00152425].||percentage of subjects|||Number
710361|NCT00160524|Secondary|Plasma Concentration of Certolizumab Pegol at Study Completion Visit or (Early) Withdrawal Visit|Plasma samples for determination of Certolizumab Pegol were taken prior to Certolizumab Pegol administration.|Study Completion Visit (Week 364) / (Early) Withdrawal Visit|Of the 595 subjects in the Safety Population, 590 subjects are included in the analysis of this outcome measure. Safety Population includes all enrolled subjects who received at least one injection of study treatment in feeder study C87031 [NCT00152490] or C87032 [NCT00152425].||μg/mL||95% Confidence Interval|Geometric Mean
710362|NCT00160524|Secondary|Percentage of Subjects in Harvey Bradshaw Index (HBI) Response (HBI Change >=3) at Study Completion Visit or (Early) Withdrawal Visit From Week 0 of Feeder Study CDP870-031 or CDP870-032|Response is defined as decrease in total Harvey Bradshaw Index (HBI) score of 3 or more points. HBI score consists of clinical parameters of general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (8 items, score 1 per item) lower scores indicating better well-being. The first three parameters are scored for the previous day.|From Week 0 of study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] to Study Completion Visit (Week 364) of this study (up to 90 months) or (Early) Withdrawal Visit|All 594 subjects in the Intention-To-Treat (ITT) Population are included in the analysis of this outcome measure. ITT Population includes all subjects of the Safety Population who provide at least one efficacy measurement after Week 0 of this study.||percentage of subjects||95% Confidence Interval|Number
710363|NCT00160524|Secondary|Percentage of Subjects Achieving Harvey Bradshaw Index (HBI) Remission (HBI ≤ 4) at Study Completion Visit or (Early) Withdrawal Visit|HBI remission is defined as total HBI score of 4 points or less. HBI score consists of clinical parameters of general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (8 items, score 1 per item) lower scores indicating better well being. The first three parameters are scored for the previous day.|Study Completion Visit (Week 364) / (Early) Withdrawal Visit|Of the 594 subjects in the Intention-To-Treat (ITT) Population, 592 subjects are included in the analysis of this outcome measure. ITT Population includes all subjects of the Safety Population who provide at least one efficacy measurement after Week 0 of this study.||percentage of subjects||95% Confidence Interval|Number
710364|NCT00160524|Primary|Percentage of Subjects With at Least One Serious Adverse Event (SAE) During the Duration of This Study CDP870-033 (up to 84 Months)|An SAE is defined as any untoward medical occurrence that occurs at any dose which results in death, is life threatening, requires hospitalization, results in persistent/significant disability/incapacity, is an infection that requires parenteral antibiotics, is a congenital anomaly/birth defect, or is an important medical event.|Up to 84 months from Study Entry (Week 0) to the Study End (Week 364) and the Safety Follow-up (Week 374)|All 595 subjects in the Safety Population are included in the analysis of this outcome measure. Safety Population includes all enrolled subjects who received at least one injection of study treatment in feeder study C87031 [NCT00152490] or C87032 [NCT00152425].||percentage of subjects|||Number
710365|NCT00160524|Primary|Percentage of Subjects With at Least One Adverse Event (AE) During the Duration of the Study CDP870-033 (up to 84 Months)|An AE is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.|Up to 84 months from Study Entry (Week 0) to the Study End (Week 364) and the Safety Follow-up (Week 374)|All 595 subjects in the Safety Population are included in the analysis of this outcome measure. Safety Population includes all enrolled subjects who received at least one injection of study treatment in feeder study C87031 [NCT00152490] or C87032 [NCT00152425].||percentage of subjects|||Number
710366|NCT00160563|Secondary|Time to Onset of Asthma in the Subset of Subjects Still Asthma Free After First 18 Months.||18 months (from the end of the preceding A00309 - NCT00152464 trial onwards.)|Analysis was not performed due to premature discontinuation of the study.|||||
710367|NCT00160563|Primary|Time to Onset of Asthma||36 months (from the randomization visit to the preceding A00309 - NCT00152464 trial onwards.)|Analysis was not performed due to premature discontinuation of the study.|||||
710368|NCT00160641|Secondary|Change From Baseline to Completion/Withdrawal Visit in Short-Form Health Survey (SF-36) Item Questionnaire Mental Component Summary (MCS) Score|The SF-36 is a 36-item generic health status measure that measures 8 general health concepts: Physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each domain of the eight domains and the summary concept MCS score are scored to yield values between 0 (worst) and 100 (best).|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)|Of the 567 subjects in the Safety Set (SS), 527 are included in this analysis. Data not available for 40 subjects.||units on a scale||Standard Deviation|Mean
710443|NCT00162097|Secondary|Number of Participants With Identified Electrocardiogram (ECG) Abnormalities|ECG abnormalities are findings that are clinically meaningful by the judgment of the investigator. A 12-lead ECG was performed and all ECG recordings were evaluated by the investigator. Abnormalities, if present at any study time point, were listed.|From screening (within 21 days of Day 1 dosing) to the study discharge day (Day 2 for AM dosing or Day 3 for PM dosing)|All participants who received study drug on Day 1 were included in the analysis.||participants|||Number
710369|NCT00160641|Secondary|Change From Baseline to Completion/Withdrawal Visit in Short-Form Health Survey (SF-36) Item Questionnaire Physical Component Summary (PCS) Score|The SF-36 is a 36-item generic health status measure that measures 8 general health concepts: Physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each domain of the eight domains and the summary concept PCS score are scored to yield values between 0 (worst) and 100 (best).|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)|Of the 567 subjects in the Safety Set (SS), 527 are included in this analysis. Data not available for 40 subjects.||units on a scale||Standard Deviation|Mean
710370|NCT00160641|Secondary|Percentage of Subjects With Good European League Against Rheumatism (EULAR) Response at Completion/Withdrawal Visit|Good EULAR response is defined as DAS28[ESR] improvement from Baseline of the preceding double-blind study > 1.2 and DAS28[ESR] value < 3.2.|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)|Of the 567 subjects in the Safety Set (SS), 556 are included in this analysis. Data not available for 11 subjects.||percentage of participants|||Number
710371|NCT00160641|Secondary|Change From Baseline to Completion/Withdrawal Visit in Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28[ESR])|DAS28[ESR] is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) Erythrocyte Sedimentation Rate (ESR in mm/ hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity. A negative value in DAS28[ESR] change from Baseline indicates an improvement from Baseline.|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)|Of the 567 subjects in the Safety Set (SS), 556 are included in this analysis. Data not available for 11 subjects.||units on a scale||Standard Deviation|Mean
710372|NCT00160641|Secondary|Change From Baseline to Completion/Withdrawal Visit in Duration of Morning Stiffness|Morning stiffness is defined as the time in hours elapsed between the time of usual awakening (even if not in the morning) and the time the subject is as limber as he/she will be during a day involving typical activities. A negative value in duration of morning stiffness change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)|Of the 567 subjects in the Safety Set (SS), 563 are included in this analysis. Data not available for 4 subjects.||hours||Standard Deviation|Mean
710373|NCT00160641|Secondary|Change From Baseline of the Preceding Double-Blind Study to Completion/Withdrawal Visit in Health Assessment Questionnaire - Disability Index (HAQ-DI) Total Score|The HAQ-DI assesses the degree of difficulty experienced in eight domains (Dressing and Grooming, Arising, Eating, Walking, Hygiene, Reach, Gripping, Other Activities) of daily living activities using 20 questions. The HAQ-DI is calculated by summing the domain scores and dividing them by the number of domains. It ranges from 0 (no difficulty) to 3 (unable to do). Negative values indicate an improvement from Baseline to the Post-Baseline Visit with larger negative values showing a better improvement.|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)|Of the 567 subjects in the Safety Set (SS), 560 are included in this analysis. Data not available for 7 subjects.||units on a scale||Standard Deviation|Mean
710374|NCT00160641|Secondary|Change From Baseline of the Preceding Double-Blind Study to Week 104 in Modified Total Sharp Score (mTSS)|The mTSS quantifies the extent of bone erosions and joint space narrowing for 44 and 42 joints, respectively, as assessed by x-rays of the hands and feet. The score ranges from 0 to 448 with higher scores representing greater damage. A negative value in mTSS change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|From Baseline of the preceding double-blind study to Week 104 of the open-label study|Of the 567 subjects in the Safety Set (SS), 423 are included in this analysis. Data not available for 144 subjects.||units on a scale||Standard Deviation|Mean
710375|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Completion/Withdrawal|The assessments are based on a 70 % or greater improvement from Baseline to Completion/Withdrawal in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)|Of the 567 subjects in the Safety Set (SS), 565 are included in this analysis. Data not available for 2 subjects.||percentage of participants||95% Confidence Interval|Number
710376|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 244|The assessments are based on a 70 % or greater improvement from Baseline to Week 244 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 244 of the open-label study|Of the 567 subjects in the Safety Set (SS), 72 are included in this analysis. Data not available for 495 subjects.||percentage of participants||95% Confidence Interval|Number
710409|NCT00160693|Primary|Percentage of Subjects With at Least One Adverse Event (AE) During the Study Period of 8 Years|"An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage.
First dose of CZP was at Baseline of one of the feeder studies C87011 [NCT00548834] or C87014 [NCT00544154] for subjects randomized to CZP, or at First Visit (Week 0) of this study for subjects randomized to Placebo."|From first dose of CZP up to 8 years|Safety Set (SS).||percentage of subjects|||Number
710377|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 196|The assessments are based on a 70 % or greater improvement from Baseline to Week 196 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 196 of the open-label study|Of the 567 subjects in the Safety Set (SS), 367 are included in this analysis. Data not available for 200 subjects.||percentage of participants||95% Confidence Interval|Number
710378|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 148|The assessments are based on a 70 % or greater improvement from Baseline to Week 148 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 148 of the open-label study|Of the 567 subjects in the Safety Set (SS), 410 are included in this analysis. Data not available for 157 subjects.||percentage of participants||95% Confidence Interval|Number
710379|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 100|The assessments are based on a 70 % or greater improvement from Baseline to Week 100 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 100 of the open-label study|Of the 567 subjects in the Safety Set (SS), 442 are included in this analysis. Data not available for 125 subjects.||percentage of participants||95% Confidence Interval|Number
710380|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 52|The assessments are based on a 70 % or greater improvement from Baseline to Week 52 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 52 of the open-label study|Of the 567 subjects in the Safety Set (SS), 493 are included in this analysis. Data not available for 74 subjects.||percentage of participants||95% Confidence Interval|Number
710381|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Completion/Withdrawal|The assessments are based on a 50 % or greater improvement from Baseline to Completion/Withdrawal in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)|Of the 567 subjects in the Safety Set (SS), 565 are included in this analysis. Data not available for 2 subjects.||percentage of participants||95% Confidence Interval|Number
710382|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 244|The assessments are based on a 50 % or greater improvement from Baseline to Week 244 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 244 of the open-label study|Of the 567 subjects in the Safety Set (SS), 72 are included in this analysis. Data not available for 495 subjects.||percentage of participants||95% Confidence Interval|Number
710383|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 196|The assessments are based on a 50 % or greater improvement from Baseline to Week 196 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 196 of the open-label study|Of the 567 subjects in the Safety Set (SS), 367 are included in this analysis. Data not available for 200 subjects.||percentage of participants||95% Confidence Interval|Number
710410|NCT00160706|Secondary|Fecal Calprotectin Level at Week 256 or (Early) Withdrawal Visit, if it is Earlier Than Week 256||Week 256 / (Early) Withdrawal Visit, if it is earlier than Week 256|Of the 309 subjects in the Intention-To-Treat (ITT) Population, 280 subjects are included in the analysis of this outcome measure. ITT Population includes all subjects of the Safety Population who provide at least one efficacy measurement after Week 0 of this study.||µg/g stool||95% Confidence Interval|Geometric Mean
710384|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 148|The assessments are based on a 50 % or greater improvement from Baseline to Week 148 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 148 of the open-label study|Of the 567 subjects in the Safety Set (SS), 410 are included in this analysis. Data not available for 157 subjects.||percentage of participants||95% Confidence Interval|Number
710385|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 100|The assessments are based on a 50 % or greater improvement from Baseline to Week 100 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 100 of the open-label study|Of the 567 subjects in the Safety Set (SS), 442 are included in this analysis. Data not available for 125 subjects.||percentage of participants||95% Confidence Interval|Number
710386|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 52|The assessments are based on a 50 % or greater improvement from Baseline to Week 52 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 52 of the open-label study|Of the 567 subjects in the Safety Set (SS), 493 are included in this analysis. Data not available for 74 subjects.||percentage of participants||95% Confidence Interval|Number
710387|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Completion/Withdrawal|The assessments are based on a 20 % or greater improvement from Baseline to Completion/Withdrawal in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)|Of the 567 subjects in the Safety Set (SS), 565 are included in this analysis. Data not available for 2 subjects.||percentage of participants||95% Confidence Interval|Number
710388|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 244|The assessments are based on a 20 % or greater improvement from Baseline to Week 244 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 244 of the open-label study|Of the 567 subjects in the Safety Set (SS), 72 are included in this analysis. Data not available for 495 subjects.||percentage of participants||95% Confidence Interval|Number
710389|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 196|The assessments are based on a 20 % or greater improvement from Baseline to Week 196 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 196 of the open-label study|Of the 567 subjects in the Safety Set (SS), 367 are included in this analysis. Data not available for 200 subjects.||percentage of participants||95% Confidence Interval|Number
710390|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 148|The assessments are based on a 20 % or greater improvement from Baseline to Week 148 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 148 of the open-label study|Of the 567 subjects in the Safety Set (SS), 410 are included in this analysis. Data not available for 157 subjects.||percentage of participants||95% Confidence Interval|Number
710411|NCT00160706|Secondary|C-Reactive Protein (CRP) Level at Study Completion Visit or (Early) Withdrawal Visit||Study Completion Visit (Week 362) / (Early) Withdrawal Visit|All 309 subjects in the Intention-To-Treat (ITT) Population are included in the analysis of this outcome measure. ITT Population includes all subjects of the Safety Population who provide at least one efficacy measurement after Week 0 of this study.||mg/L||95% Confidence Interval|Geometric Mean
710391|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 100|The assessments are based on a 20 % or greater improvement from Baseline to Week 100 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 100 of the open-label study|Of the 567 subjects in the Safety Set (SS), 442 are included in this analysis. Data not available for 125 subjects.||percentage of participants||95% Confidence Interval|Number
710392|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 52|The assessments are based on a 20 % or greater improvement from Baseline to Week 52 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 52 of the open-label study|Of the 567 subjects in the Safety Set (SS), 493 are included in this analysis. Data not available for 74 subjects.||percentage of participants||95% Confidence Interval|Number
710393|NCT00160641|Primary|Percentage of Subjects Who Withdrew Due to an Adverse Event (AE) During the Study|"An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device.
The event does not necessarily have a causal relationship with that treatment or usage. The results of this Primary Outcome Measure are summarized from the Adverse Event pages of the Case Report Forms."|From Entry Visit (Week 0) to the end of the study (approximately 6.3 years)|Safety Set||percentage of participants|||Number
710394|NCT00160641|Primary|Percentage of Subjects With at Least One Serious Adverse Event (SAE) From First Certolizumab Pegol (CZP) Dose up to Approximately 6.8 Years|"A SAE is any untoward medical occurrence that at any dose:
Results in death
Is life-threatening
Requires in patient hospitalisation or prolongation of existing hospitalisation
Results in persistent or significant disability/incapacity, or
Is a congenital anomaly or birth defect
Is as infection that requires treatment parenteral antibiotics
Other important medical events which based on medical or scientific judgement may jeopardise the patients, or may require medical or surgical intervention to prevent any of the above
First dose of CZP was at Baseline of the preceding double-blind study NCT00160602 for subjects randomized to CZP, or at Entry Visit (Week 0) of this study for subjects randomized to Placebo."|From first dose of CZP to the end of the open-label study (approximately 6.8 years)|Safety Set||percentage of participants|||Number
710395|NCT00160641|Primary|Percentage of Subjects With at Least One Adverse Event (AE) From First Certolizumab Pegol (CZP) Dose up to Approximately 6.8 Years|An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage. First dose of CZP was at Baseline of the preceding double-blind study NCT00160602 for subjects randomized to CZP, or at Entry Visit (Week 0) of this study for subjects randomized to Placebo.|From first dose of CZP to the end of the open-label study (approximately 6.8 years)|Safety Set||percentage of participants|||Number
710396|NCT00160693|Secondary|Percentage of Subjects Utilizing Common Additional Arthritis Medications During the Study Period of 8 Years|This Secondary Outcome Measure shows additional arthritis medications received by at least 20% of subjects during the 8-year study.|From First Visit (Week 0 in this study) up to 8 years|Safety Set (SS).||percentage of subjects|||Number
710397|NCT00160693|Secondary|Percentage of Subjects Who Withdrew Due to Lack of Efficacy During the Study Period of 8 Years||From First Visit (Week 0 in this study) up to 8 years|Safety Set (SS).||percentage of subjects|||Number
710398|NCT00160693|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ- DI) at Completion Visit or Early Withdrawal Visit|The HAQ-DI assesses the degree of difficulty experienced in eight domains (Dressing and Grooming, Arising, Eating, Walking, Hygiene, Reach, Gripping, Other Activities) of daily living activities using 20 questions. The HAQ-DI is calculated by summing the domain scores and dividing them by the number of domains. It ranges from 0 (no difficulty) to 3 (unable to do). Negative values indicate an improvement from Baseline to the Post-Baseline Visit with larger negative values showing a better improvement.|From Baseline to Completion Visit/ early Withdrawal Visit, up to 8 years|Of the 402 subjects in the Safety Set (SS), 400 subjects are included in this analysis, because they had available data at Baseline and Completion or early Withdrawal Visit.||units on a scale||Standard Deviation|Mean
710399|NCT00160693|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 70% Response Criteria (ACR70) at Completion Visit or Early Withdrawal Visit|The assessments are based on a 70% or greater improvement from Baseline to the Completion Visit or early Withdrawal Visit in the number of tender joints, a 70% or more improvement in the number of swollen joints, and a 70% or greater improvement in 3 of the 5 remaining core set measures: Patient’s Global Assessment of Disease Activity (PtGADA), Physician’s Global Assessment of Disease Activity (PhGADA), Patient’s Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire – Disability Index (HAQ-DI) and C-Reactive Protein (CRP).|From Baseline to Completion Visit/ early Withdrawal Visit, up to 8 years|Safety Set (SS).||percentage of subjects||95% Confidence Interval|Number
710400|NCT00160693|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 50% Response Criteria (ACR50) at Completion Visit or Early Withdrawal Visit|The assessments are based on a 50% or greater improvement from Baseline to the Completion Visit or early Withdrawal Visit in the number of tender joints, a 50% or more improvement in the number of swollen joints, and a 50% or greater improvement in 3 of the 5 remaining core set measures: Patient’s Global Assessment of Disease Activity (PtGADA), Physician’s Global Assessment of Disease Activity (PhGADA), Patient’s Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire – Disability Index (HAQ-DI) and C-Reactive Protein (CRP).|From Baseline to Completion Visit/ early Withdrawal Visit, up to 8 years|Safety Set (SS).||percentage of subjects||95% Confidence Interval|Number
710401|NCT00160693|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Completion Visit or Early Withdrawal Visit|The assessments are based on a 20% or greater improvement from Baseline to the Completion Visit or early Withdrawal Visit in the number of tender joints, a 20% or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient’s Global Assessment of Disease Activity (PtGADA), Physician’s Global Assessment of Disease Activity (PhGADA), Patient’s Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire – Disability Index (HAQ-DI) and C-Reactive Protein (CRP).|From Baseline to Completion Visit/ early Withdrawal Visit, up to 8 years|Safety Set (SS).||percentage of subjects||95% Confidence Interval|Number
710402|NCT00160693|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 316|"The assessments are based on a 20% or greater improvement from Baseline to Week 316 in the number of tender joints, a 20% or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient’s Global Assessment of Disease Activity (PtGADA), Physician’s Global Assessment of Disease Activity (PhGADA), Patient’s Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire – Disability Index (HAQ-DI) and C-Reactive Protein (CRP).
Baseline is Baseline of the respective feeder study."|From Baseline to Week 316|Of the 402 subjects in the Safety Set (SS), 140 subjects are included in this analysis, because they had available data at Baseline and Week 316.||percentage of subjects||95% Confidence Interval|Number
710403|NCT00160693|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 256|"The assessments are based on a 20% or greater improvement from Baseline to Week 256 in the number of tender joints, a 20% or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient’s Global Assessment of Disease Activity (PtGADA), Physician’s Global Assessment of Disease Activity (PhGADA), Patient’s Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire – Disability Index (HAQ-DI) and C-Reactive Protein (CRP).
Baseline is Baseline of the respective feeder study."|From Baseline to Week 256|Of the 402 subjects in the Safety Set (SS), 211 subjects are included in this analysis, because they had available data at Baseline and Week 256.||percentage of subjects||95% Confidence Interval|Number
710404|NCT00160693|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 208|"The assessments are based on a 20% or greater improvement from Baseline to Week 208 in the number of tender joints, a 20% or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient’s Global Assessment of Disease Activity (PtGADA), Physician’s Global Assessment of Disease Activity (PhGADA), Patient’s Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire – Disability Index (HAQ-DI) and C-Reactive Protein (CRP).
Baseline is Baseline of the respective feeder study."|From Baseline to Week 208|Of the 402 subjects in the Safety Set (SS), 223 subjects are included in this analysis, because they had available data at Baseline and Week 208.||percentage of subjects||95% Confidence Interval|Number
710405|NCT00160693|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 160|"The assessments are based on a 20% or greater improvement from Baseline to Week 160 in the number of tender joints, a 20% or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient’s Global Assessment of Disease Activity (PtGADA), Physician’s Global Assessment of Disease Activity (PhGADA), Patient’s Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire – Disability Index (HAQ-DI) and C-Reactive Protein (CRP).
Baseline is Baseline of the respective feeder study."|From Baseline to Week 160|Of the 402 subjects in the Safety Set (SS), 247 subjects are included in this analysis, because they had available data at Baseline and Week 160.||percentage of subjects||95% Confidence Interval|Number
710406|NCT00160693|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 100|"The assessments are based on a 20% or greater improvement from Baseline to Week 100 in the number of tender joints, a 20% or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient’s Global Assessment of Disease Activity (PtGADA), Physician’s Global Assessment of Disease Activity (PhGADA), Patient’s Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire – Disability Index (HAQ-DI) and C-Reactive Protein (CRP).
Baseline is Baseline of the respective feeder study."|From Baseline to Week 100|Of the 402 subjects in the Safety Set (SS), 275 subjects are included in this analysis, because they had available data at Baseline and Week 100.||percentage of subjects||95% Confidence Interval|Number
710407|NCT00160693|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 52|"The assessments are based on a 20% or greater improvement from Baseline to Week 52 in the number of tender joints, a 20% or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient’s Global Assessment of Disease Activity (PtGADA), Physician’s Global Assessment of Disease Activity (PhGADA), Patient’s Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire – Disability Index (HAQ-DI) and C-Reactive Protein (CRP).
Baseline is Baseline of the respective feeder study."|From Baseline to Week 52|Of the 402 subjects in the Safety Set (SS), 370 subjects are included in this analysis, because they had available data at Baseline and Week 52.||percentage of subjects||95% Confidence Interval|Number
710408|NCT00160693|Primary|Percentage of Subjects Who Withdrew Due to an Adverse Event (AE) During the Study Period of 8 Years|"An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage.
The results of this Primary Outcome Measure are summarized from the Adverse Event pages of the Case Report Forms."|From First Visit (Week 0 in this study) up to 8 years|Safety Set (SS).||percentage of subjects|||Number
710422|NCT00161213|Primary|Progression-free Survival|Progression-free survival in months.|4 years|A total of 44 patients were enrolled. One patient withdrew consent before starting treatment. One patient was determined, after initiating treatment, to have an ampullary cancer and was evaluable for toxicity but not for response.||months||95% Confidence Interval|Median
710412|NCT00160706|Secondary|Percentage of Subjects With Positive Anti-CZP Anti-body Status at Any Time From Week 0 of the Feeder Studies CDP870-031 or CDP870-032 to the Study Completion Visit in CDP870-034|Subjects are counted as antibody positive to Certolizumab Pegol if they have at least one positive result from Week 0 in one of the previous studies CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] to the last Visit in this study. A positive result is defined as Anti-CZP antibody levels > 2.4 units/mL.|From Week 0 of study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] up to Study Completion Visit (Week 362) of CDP870-034 (up to 90 months)|Of the 310 subjects in the Safety Population, 309 subjects are included in the analysis of this outcome measure. Safety Population includes all enrolled subjects who received at least one injection of study treatment in feeder study C87031 [NCT00152490] or C87032 [NCT00152425].||percentage of subjects|||Number
710413|NCT00160706|Secondary|Plasma Concentration of Certolizumab Pegol at Study Completion Visit or (Early) Withdrawal Visit|Plasma Samples for determination of Certolizumab Pegol were taken prior to Certolizumab Pegol administration.|Study Completion Visit (Week 362) / (Early) Withdrawal Visit|Of the 310 subjects in the Safety Population, 307 subjects are included in the analysis of this outcome measure. Safety Population includes all enrolled subjects who received at least one injection of study treatment in feeder study C87031 [NCT00152490] or C87032 [NCT00152425].||µg/mL||95% Confidence Interval|Geometric Mean
710414|NCT00160706|Secondary|Percentage of Subjects in Harvey Bradshaw Index (HBI) Response (HBI Change ≥ 3) at Study Completion Visit or (Early) Withdrawal Visit From Week 0 of CDP870-034|Response is defined as decrease in total Harvey Bradshaw Index (HBI) score of 3 or more points. HBI score consists of clinical parameters of general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (8 items, score 1 per item) lower scores indicating better well being. The first three parameters are scored for the previous day.|From Week 0 of study CDP870-034 to Study Completion Visit (Week 362) or (Early) Withdrawal Visit (up to 84 months)|Of the 309 subjects in the Intention-To-Treat (ITT) Population, 299 subjects are included in the analysis of this outcome measure. ITT Population includes all subjects of the Safety Population who provide at least one efficacy measurement after Week 0 of this study.||percentage of subjects||95% Confidence Interval|Number
710415|NCT00160706|Secondary|Percentage of Subjects in Harvey Bradshaw Index (HBI) Response (HBI Change ≥ 3) at Study Completion Visit or (Early) Withdrawal Visit From Week 0 of Feeder Study CDP870-031 or CDP870-032|Response is defined as decrease in total Harvey Bradshaw Index (HBI) score of 3 or more points. HBI score consists of clinical parameters of general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (8 items, score 1 per item) lower scores indicating better well being. The first three parameters are scored for the previous day.|From Baseline of study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] to Study Completion Visit (Week 362) or (Early) Withdrawal Visit of this study (up to 90 months)|Of the 309 subjects in the Intention-To-Treat (ITT) Population, 307 subjects are included in the analysis of this outcome measure. ITT Population includes all subjects of the Safety Population who provide at least one efficacy measurement after Week 0 of this study.||percentage of subjects||95% Confidence Interval|Number
710416|NCT00160706|Secondary|Percentage of Subjects Achieving Harvey Bradshaw Index (HBI) Remission (HBI ≤ 4) at Study Completion Visit or (Early) Withdrawal Visit|HBI remission is defined as total HBI score of 4 points or less. HBI score consists of clinical parameters of general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (8 items, score 1 per item) lower scores indicating better well being. The first three parameters are scored for the previous day.|Study Completion Visit (Week 362) / (Early) Withdrawal Visit|All 309 subjects in the Intention-To-Treat (ITT) Population are included in the analysis of this outcome measure. ITT Population includes all subjects of the Safety Population who provide at least one efficacy measurement after Week 0 of this study.||percentage of subjects||95% Confidence Interval|Number
710417|NCT00160706|Primary|Percentage of Subjects With at Least One Serious Adverse Event (SAE) During the Duration of This Study CDP870-034 (up to 84 Months)|An SAE is defined as any untoward medical occurrence that occurs at any dose which results in death, is life threatening requires hospitalization, results in persistent/significant disability/incapacity, is an infection that requires parenteral antibiotics, is a congenital anomaly/birth defect, or is an important medical event.|Up to 84 months from Study Entry (Week 0) to the Study End (Week 362 ) and the Safety Follow-up (Week 372)|All 310 subjects in the Safety Population are included in the analysis of this outcome measure. Safety Population includes all enrolled subjects who received at least one injection of study treatment in feeder study C87031 [NCT00152490] or C87032 [NCT00152425].||percentage of subjects|||Number
710418|NCT00160706|Primary|Percentage of Subjects With at Least One Adverse Event (AE) During the Duration of This Study CDP870-034 (up to 84 Months)|An AE is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.|Up to 84 months from Study Entry (Week 0) to the Study End (Week 362 ) and the Safety Follow-up (Week 372)|All 310 subjects in the Safety Population are included in the analysis of this outcome measure. Safety Population includes all enrolled subjects who received at least one injection of study treatment in feeder study C87031 [NCT00152490] or C87032 [NCT00152425].||percentage of subjects|||Number
710419|NCT00161213|Secondary|Overall Survival||5 years|A total of 44 patients were enrolled. One patient withdrew consent before starting treatment. One patient was determined, after initiating treatment, to have an ampullary cancer and was evaluable for toxicity but not for response.||months||95% Confidence Interval|Median
710420|NCT00161213|Secondary|1-year Survival Rate|Percentage of subjects who survive up to 1 year|5 years|A total of 44 patients were enrolled. One patient withdrew consent before starting treatment. One patient was determined, after initiating treatment, to have an ampullary cancer and was evaluable for toxicity but not for response.||percentage of total evaluable subjects||95% Confidence Interval|Number
710421|NCT00161213|Secondary|Response Rate|"Response rate as defined by a best response of Stable Disease or better."|5 years|A total of 44 patients were enrolled. One patient withdrew consent before starting treatment. One patient was determined, after initiating treatment, to have an ampullary cancer and was evaluable for toxicity but not for response. Seven subjects were not assessed for response as they discontinued therapy treatment before response was assessed.||percentage of total evaluable subjects||95% Confidence Interval|Number
710423|NCT00161382|Secondary|Proportion of Students That Are Sexually Active||Measured over a period of 30 days||||||
710430|NCT00161382|Primary|Initiation of Sexual Intercourse|The effect of the intervention on delayed sexual initiation at the 9th-grade follow-up for those students who reported no lifetime sexual activity at baseline was assessed as the primary outcome. The primary hypothesis tested was that the intervention would decrease the number of adolescents who initiated sexual activity by the ninth grade relative to those in the comparison schools. Sexual activity was defined as participation in vaginal, oral, or anal sex. Sexual activity questions were defined in advance and were worded in a gender-neutral manner to illicit responses for same and opposite-sex partners.|Measured throughout the study, and at 2006/2007 school year|||participants|||Number
710431|NCT00161473|Secondary|Change in Brief Psychiatric Rating Scale (BPRS) Total Score Over the Course of Study Participation|"The Brief Psychiatric Rating Scale (BPRS) is an 18-item scale that rates psychiatric symptoms. Each item ranges from 1 to 7. Therefore, the Brief Psychiatric Rating Scale total score ranges from a minimum of 0 to a maximum of 126, where 126 indicates higher levels of behavioral symptoms.
A change Brief Psychiatric Rating Scale score that is a negative number (that is, a Brief Psychiatric Rating Scale score decrease), indicates behavioral improvement."|Weeks 2, 4, 6, and 8 (change from Baseline)|"Participants with at least one follow-up behavioral assessment visit were included in this analysis.
The mean group change was determined by calculating the mean of each participant's follow-up measures, subtracting this mean from the baseline value, and then from these values, calculating group means and standard deviations."||units on a scale||Standard Deviation|Mean
710432|NCT00161473|Secondary|Number of Behavioral Assessment Visits Completed|This measure reflects the length of time participants remained in the study. There were 6 behavioral assessment visits included in the protocol.|Last behavioral assessment (Baseline, Weeks 1, 2, 4, 6, or 8)|||number of visits||Standard Deviation|Mean
710433|NCT00161473|Primary|Change in Neuropsychiatric Inventory (NPI) Total Score Over the Course of Study Participation|"The Neuropsychiatric Inventory (NPI) is a 12-item scale that assesses the frequency and severity of behavioral symptoms in patients with dementia. Each Neuropsychiatric Inventory item ranges from 0 to 12. Therefore the Neuropsychiatric Inventory total score has a minimum total value of 0 and maximum 144, where 144 indicates higher levels of behavioral symptoms.
A change in Neuropsychiatric Inventory total score that is a negative number (that is, an Neuropsychiatric Inventory score decrease), indicates behavioral improvement."|Weeks 2, 4, 6, and 8 (change from Baseline)|"Participants with at least one follow-up behavioral assessment visit were included in this analysis.
The mean group change was calculated by calculating the mean of each participant's follow-up measures, subtracting this mean from the baseline value, and then from these values, calculating group means and standard deviations."||units on a scale||Standard Deviation|Mean
710434|NCT00161473|Primary|Mean Clinical Global Impression of Change (CGIC) at Last Observation|"The Clinical Global Impression of Change (CGIC) is a 7 point scale, where 1 indicates markedly improved, 4 indicates no change, and 7 indicates markedly worse."|Week 8|Participants with at least one follow-up behavioral assessment visit were included in this analysis||units on a scale||Standard Deviation|Mean
710435|NCT00161616|Secondary|Number of Patients Achieving Combined Clinical and Radiographic Endpoint (CCRE)|Patients categorized as Success or Failure of CCRE. Success defined as a fracture judged to be both clinically healed by clinical investigator, “healed” (see primary outcome), and radiographically united by independent, blinded radiology panel, “united.” Patients deemed “not healed” or “not united” were assessed as failures.|1 year|All patients randomized were analyzed.||patients|||Number
710436|NCT00161616|Primary|Number of Patients With Healed Fractures|Patients categorized by investigator as healed, not healed, no outcome (using pre-specified criteria). Healed: no tenderness at fracture site or pain with weight bearing, presence of bridging callus or disappearance of fracture lines, no hardware failure, no secondary intervention to promote fracture healing. Not healed: diagnosis of delayed union or nonunion, hardware failure, secondary intervention procedure for fracture healing recommended or performed, or conduct of procedure that may interfere with fracture healing. No outcome: subjects who did not achieve either healed or not healed.|13 and 20 weeks|All patients randomized were analyzed.||patients|||Number
710437|NCT00162032|Secondary|In Addition, a Determination of the Safety of Sestamibi Will be Evaluated at the End of the Study Through Adverse and Serious Adverse Events Reported and Evaluating Vital Signs, ECGs, Physical Exams and Laboratory Tests for Each Subject.||3 year follow up||||||
710438|NCT00162032|Secondary|Concordance Will be Determined Between the Presence of Perfusion Abnormalities Detected on Sestamibi Images and the Classification of Ischemic Heart Disease.||3 year follow up||||||
710439|NCT00162032|Primary|Kawasaki Disease Population at High and Low Risk of Developing Cardiac Events Though Three Years Follow-up.|The proportion of all patients who experienced cardiac events among patients with abnormal (SSS >=4, high risk) and normal (SSS <4, low risk) Cardiolite MPI scans during the follow-up period. A log-rank statistic (2-sided, alpha = 0.05) was computed to compare cardiac event-free survival in the high risk and low risk groups. The cardiac event rate is the cumulative event rate based on a Kaplan-Meier estimate conditional on the SPECT MPI score result.|3 years|Had SPECT Myocardial perfusion imaging tests and experienced a cardiac event||proportion of participants||95% Confidence Interval|Number
710440|NCT00162097|Secondary|Number of Participants With Abnormal Physical Examination Findings at Baseline (Screening and/or Day 1)|The physical examination included an evaluation of the participant's height and body mass index (BMI) (at screening only), and weight. Abnormal physical examination are findings that are clinically meaningful by the judgment of the investigator|From screening (within 21 days of Day 1 dosing) to the study discharge day (Day 2 for AM dosing or Day 3 for PM dosing)|All participants who received study drug on Day 1 were included in the analysis. Physical examination findings were not analysed at discharge.||participants|||Number
710441|NCT00162097|Secondary|Number of Participants With Clinically Meaningful Vital Signs Measures|Vital signs were recorded throughout the study and included investigations related to body temperature, respiratory rate, seated blood pressure (systolic and diastolic), and heart rate. The investigator used his/her clinical judgement to decide whether or not abnormalities in vital signs were clinically meaningful.|From screening (within 21 days of Day 1 dosing) to the study discharge day (Day 2 for AM dosing or Day 3 for PM dosing)|All participants who received study drug on Day 1 were included in the analysis.||participants|||Number
710442|NCT00162097|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax)|Tmax was obtained directly from the concentration-time data.|Blood samples were collected at time 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose, relative to administration of PM or AM dose.|The analysis was performed per protocol.||hours||Full Range|Median
710444|NCT00162097|Secondary|Number of Participants With Urinalysis MAs|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following urinalysis MA definitions specify the criteria for MAs in the data presented. The presence of white blood cells (WBCs) and red blood cells (RBCs) in the urine was graded on a scale: 0 = no cells present (negative); trace =a small number of cells present; then 1+, 2+, 3+ and 4+, denoting increasingly “positive” urine results (ie, WBCs/RBCs present in the urine). The MA for both WBCs and RBCs was >= 2+ (or, if pre-treatment value >=2+, then >= 4+).|Throughout study, from screening (within 21 days of Day 1 dosing) through Day 3.|All participants who received study drug on Day 1 and were evaluated for these measures.||participants|||Number
710445|NCT00162097|Secondary|Number of Participants With Serum Chemistry MAs|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify the criteria for MAs in the data presented. High bilirubin (total): >1.1 x ULN (or if pre-treatment value >ULN, then >1.25 x pre-treatment value). High creatinine: >1.33 x pre-treatment value. Low albumin: <0.9 x LLN (or if pre-treatment value <LLN, then <0.9 x pre-treatment value). High amylase (total): >2 x pre-treatment value.|Throughout study, from screening (within 21 days of Day 1 dosing) through Day 3.|All participants who received study drug on Day 1 were included in the analysis. The 'n' signifies those participants who received study drug and were evaluated for this measure, for each group respectively.||participants|||Number
710446|NCT00162097|Secondary|Number of Participants With Marked Abnormalities (MAs) in Hematology Measurements|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following hematology MA definitions specify the criteria for the data presented. Low platelet count: <0.85 x lower limit of normal (LLN) (or if pre-treatment value <LLN, then <0.85 x pre-treatment value). Low leukocytes: <0.9 x LLN (or if pre-treatment value <LLN, then <0.85 x pre-treatment value. If pre-treatment value >upper limit of normal [ULN], then <LLN). Low neutrophils+bands (absolute): <=1.500 10^3 cells/microliter (uL). Low lymphocytes (absolute): <0.750 10^3 cells/uL.|Throughout study, from screening (within 21 days of Day 1 dosing) through Day 3.|All participants who received study drug on Day 1 and were evaluated for these measures.||participants|||Number
710447|NCT00162097|Secondary|Number of Participants Who Experienced AEs Leading to Study Drug Discontinuation|AEs were defined as any new untoward medical occurrences or worsening of a pre-existing medical condition in a participant administered a medicinal product, whether or not considered related to the medicinal product. Participants who discontinued the study due to an AE were recorded.|From screening (within 21 days of Day 1 dosing) to the study discharge day (Day 2 for AM dosing or Day 3 for PM dosing).|All participants who received study drug on Day 1 were included in the analysis.||participants|||Number
710448|NCT00162097|Secondary|Number of Participants Who Experienced AEs|AEs were defined as any new untoward medical occurrences or worsening of a pre-existing medical condition in a participant administered a medicinal product, whether or not considered related to the medicinal product.|From screening (within 21 days of Day 1 dosing) to the study discharge day (Day 2 for AM dosing or Day 3 for PM dosing).|All participants who received study drug on Day 1 were included in the analysis.||participants|||Number
710449|NCT00162097|Primary|Area Under the Plasma Concentration-time Curve Over the Dosing Interval of 24 Hours (AUC[TAU])|The AUC(TAU), from time 0 to the time of the last measurable concentration (t), was calculated by the linear trapezoidal rule.|Blood samples were collected at time 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose, relative to administration of PM or AM dose.|The analysis was performed per protocol.||mcg*h/mL||Full Range|Geometric Mean
710450|NCT00162097|Primary|Minimum Plasma Concentration (Cmin)|Cmin was obtained directly from the concentration-time data.|Blood samples were collected at time 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose, relative to administration of PM or AM dose.|The analysis was performed per protocol.||mcg/mL||Full Range|Geometric Mean
710451|NCT00162097|Secondary|Number of Participants Who Died or Experienced Other Serious Adverse Events (SAEs)|An SAE was defined as any adverse event (AE) occurring at any dose that; resulted in death; was life threatening; resulted in a persistent or significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; was a cancer; or was an overdose.|From screening (within 21 days of Day 1 dosing) to the study discharge day (Day 2 for AM dosing or Day 3 for PM dosing). Participants were monitored for SAEs up to 30 days after study discharge.|All data from participants who signed the informed consent and enrolled in the study is included in the data set used for evaluating SAEs.||Participants|||Number
710452|NCT00162097|Primary|Maximum Plasma Concentration (Cmax)|Cmax was obtained directly from the concentration-time data.|Blood samples were collected at time 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose, relative to administration of PM or AM dose.|The analysis was performed per protocol.||micrograms (mcg)/mL||Full Range|Geometric Mean
710458|NCT00162136|Secondary|Best Tumor Response, According to Response Evaluation Criteria in Solid Tumors (RECIST)|RECIST criteria, wherein complete response = disappearance of all target lesions; partial response = 30% decrease in the sum of the longest diameter of target lesions; progressive disease = 20% increase in the sum of the longest diameter of target lesions, and stable disease = small changes that do not meet above criteria.|At Baseline (up to 2 weeks prior to starting therapy), after every 2nd cycle, and at post study follow-upn after a maximum of 9 cycles.|||Participants|||Number
710459|NCT00162136|Secondary|Mean Plasma Concentration of Ixabepilone at 40 mg/m2 Dose Level|Mean concentrations over full time period for the 40 mg/mg2 dose level, established as the Maximum Tolerated Dose. (The Maximum Tolerated Dose was established as 40 mg/m2, based on an investiagtion of Dose Limiting Toxicities, which consisted of Febrile Neutropenia (at 40 mg/m2) in 1 participant and Grade 4 neutropenia lasting ≥5 days (at 45 mg/m2)in 2 participants.)|through 72 hours after start of infusion|All participants treated at the 40 mg/m2 dose level.||ng/mL||Standard Deviation|Mean
710460|NCT00162136|Secondary|Hematology Results - Worst On-Study Grade|Worst on-study grade based on laboratory values graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. (Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death).|Baseline (within 2 weeks of dosing), weekly, and within 72 hours prior to each subsequent 21-day cycle. If CTC Grade 4 hematologic toxicity is observed, complete blood count plus differential and platelets repeated every 3 days until resolution.|||Participants|||Number
710461|NCT00162136|Secondary|Treatment Related Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation|Adverse events (AEs) and Serious AEs (SAEs) considered possibly, probably, or certainly related to study treatment, graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death).|From time of screening through post study follow-up at a maximum of 21 9-day cycles. Toxicity assessments occured at least every 4 weeks until all study drug related toxicities.|||Participants|||Number
710462|NCT00162136|Primary|Number of Participants With Dose Limiting Toxicities at Dose Level|Dose limiting toxicities=any of the following events attributed to Ixabepilone occuring during the first cycle: grade 3/4 nausea, vomiting, or diarrhea despite medical intervention and/or prophylaxis; other Grade ≥3 nonhematological toxicity; any toxicity requiring study therapy discontinuation; delayed recovery from study therapy-related toxicity which delays scheduled re-treatment for >14 days; Grade 4 neutropenia for ≥5 consecutive days; grade 3/4 neutropenia with sepsis or a fever ≥38.5 C; thrombocytopenia <25,000 cells/mm3 or bleeding requiring a platelet transfusion.|Measures taken at Cycle 01 (21-day cycle)|All treated participants||participants|||Number
710463|NCT00162266|Secondary|Mean Change From Baseline (BL) in the Mental Health Domain of the SF-36 Over Time in OL Period|SF-36=2 summaries (PCS & MCS) & 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 & a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 67.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the double-blind (DB) study. n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
710464|NCT00162266|Secondary|Mean Baseline Mental Health Domain of the SF-36 Over Time in OL Period|SF-36 = PCS & MCS & 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 & a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL & post-BL values are presented for each post-BL visit & represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 68.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n = the number of participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
710491|NCT00162266|Primary|Mean Change From Baseline (BL) in IgM in OL Period|Blood samples for immunoglobulin assessments were obtained to determine change from baseline in serum IgM. Baseline data for these time-matched cohorts are presented in Outcome Measure 9.|Baseline (Day 0) and Days 360, 720, 1080, 1440, and 1800|All treated OL participants. Participants were grouped according to the treatment they received in the double-blind (DB) study. n = the number of participants with measurements for that time point.||mg/dL||Standard Error|Mean
710465|NCT00162266|Secondary|Mean Change From Baseline (BL) in the Role-Emotional Domain of the SF-36 Over Time in OL Period|SF-36=2 summaries (PCS & MCS) & 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 & a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 65.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
710466|NCT00162266|Secondary|Mean Baseline Role-Emotional Domain of the SF-36 Over Time in OL Period|SF-36 = PCS & MCS & 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 & a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL & post-BL values are presented for each post-BL visit & represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 66.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the double-blind (DB) study. n = the number of participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
710467|NCT00162266|Secondary|Mean Change From Baseline (BL) in the Social Functioning Domain of the SF-36 Over Time in OL Period|SF-36=2 summaries (PCS & MCS) & 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 & a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 63.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
710468|NCT00162266|Secondary|Mean Baseline Social Functioning Domain of the SF-36 Over Time in OL Period|SF-36 = PCS & MCS & 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 & a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL & post-BL values are presented for each post-BL visit & represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 64.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
710469|NCT00162266|Secondary|Mean Change From Baseline (BL) in the Vitality Domain of the SF-36 Over Time in OL Period|SF-36=2 summaries (PCS & MCS) & 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 & a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 61.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
710470|NCT00162266|Secondary|Mean Baseline Vitality Domain of the SF-36 Over Time in OL Period|SF-36 = PCS & MCS & 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 & a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL & post-BL values are presented for each post-BL visit & represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 62.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n = the number of participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
710471|NCT00162266|Secondary|Mean Change From Baseline (BL) in the General Health Domain of the SF-36 Over Time in OL Period|SF-36=2 summaries (PCS & MCS) & 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 & a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 59.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n=the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
710492|NCT00162266|Secondary|Mean Change From Baseline in Serum Rheumatoid Factor Level Over Time in OL Period|Serum evaluations were carried out to determine participant change from baseline in rheumatoid factor serum concentration. Mean change from baseline = value at post-baseline OL time point-value and baseline OL time point.|Baseline (Day 0) and Days 360, 720,1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.||IU/mL||Standard Error|Mean
710472|NCT00162266|Secondary|Mean BL General Health Domain of the SF-36 Over Time in OL Period|SF-36 = PCS & MCS & 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 & a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL & post-BL values are presented for each post-BL visit & represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 60.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the double-blind (DB) study. n = the number of participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
710473|NCT00162266|Secondary|Mean Change From BL in the Bodily Pain Domain of the SF-36 Over Time in OL Period|SF-36=2 summaries (PCS & MCS) & 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 & a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 57.|BL (Day 0); Day 360; Day 720; Day 1,080; Day 1,440; Day 1,800; Day 2,160; Day 2,520; Day 2,880; Day 3,060|All treated OL participants. Participants were grouped according to the treatment they received in the double-blind (DB) study. n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
710474|NCT00162266|Secondary|Mean Baseline Bodily Pain Domain of the SF-36 Over Time in OL Period|SF-36 = PCS & MCS & 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 & a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL & post-BL values are presented for each post-BL visit & represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 58.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
710475|NCT00162266|Secondary|Mean Change From Baseline (BL) in the Role-Physical Domain of the SF-36 Over Time in OL Period|SF-36=2 summaries (PCS & MCS) & 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 & a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 55.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
710476|NCT00162266|Secondary|Mean Baseline Role-Physical Domain of the SF-36 Over Time in OL Period|SF-36 = PCS & MCS & 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 & a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL & post-BL values are presented for each post-BL visit & represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 56.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
710477|NCT00162266|Secondary|Mean Change From Baseline (BL) in the Physical Functioning Domain of the SF-36 Over Time in OL Period|SF-36=2 summaries (PCS & MCS) & 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 & a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 53.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
710478|NCT00162266|Secondary|Mean Baseline (BL) Physical Functioning Domain of the SF-36 Over Time in OL Period|SF-36 = PCS & MCS & 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 & a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL & post-BL values are presented for each post-BL visit & represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 54.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
710493|NCT00162266|Secondary|Baseline Level of Serum Rheumatoid Factor Over Time in OL Period|Serum evaluations were carried out to determine participant baseline rheumatoid factor serum concentration. Time-matched baseline(Day 0) values and post-baseline vales were presented for each post-baseline visit and represent only that cohort of participants with measurements available at that post-baseline assessment.|Baseline (Day 0) and Days 360, 720,1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.||IU/mL||Standard Deviation|Mean
710479|NCT00162266|Secondary|Mean Change From Baseline (BL) in the MCS of the SF-36 Over Time in OL Period|The SF-36 consists of 2 summaries, the PCS and the MCS, and 8 individual indexes. The MCS addresses 4 of the 8 individual indices: vitality, social functioning, role-emotional, and mental health. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from baseline=value at post-baseline OL time point-value and baseline OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 51.|Baseline (Day 0) and Days 360, 450, 540, 630, 720, 810, 900, 1080, 1350, 1440, 1530, 1620, 1710, 1800, 1980, 2160, 2340, 2520, 2700, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
710480|NCT00162266|Secondary|Mean Baseline Mental Component Summary (MCS) of the SF-36 Over Time in OL Period|SF-36=PCS, MCS, & 8 individual indices. MCS addresses 4 of the 8 indices: vitality, social functioning, role-emotional, & mental health. Subscales were scored using norm-based methods that standardized the scores to a mean of 50 & a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched baseline (Day 0) values & post-baseline (BL) values are presented for each post-BL visit & represent only that cohort with measurements available at that post-BL assessment. See Outcome Measure 51 for Change from BL.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
710481|NCT00162266|Secondary|Mean Change From Baseline (BL) in the Physical Component Summary (PCS) of the SF-36 Over Time in OL Period|The SF-36 consists of 2 summaries, the PCS and the MCS, and 8 individual indexes. The MCS addresses 4 of the 8 individual indices: vitality, social functioning, role-emotional, and mental health. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from baseline=value at post-baseline OL time point-value and baseline OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 49.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
710482|NCT00162266|Secondary|Mean Baseline Physical Component Summary (PCS) of the Short-Form 36 (SF-36) Over Time in OL Period|SF-36 = PCS & MCS & 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 & a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL & post-BL values are presented for each post-BL visit & represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 50.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
710483|NCT00162266|Secondary|Mean Change From Baseline in Level of C Reactive Protein Over Time in OL Period|Serum evaluations were carried out to evaluate participant concentrations of serum C reactive protein. Mean change from baseline=value at post-baseline OL time point-value and baseline OL time point.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n=the number of participants with measurements for that time point.||mg/dL||Standard Error|Mean
710484|NCT00162266|Secondary|Mean Baseline Serum C-Reactive Protein Level Over Time in OL Period|Serum evaluations were carried out to evaluate participant serum CRP concentrations at baseline. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|Baseline (Day 0) and Days 360, 720, 1080,1440,1800, 2160, 2520, 2880, 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.||mg/dL||Standard Deviation|Mean
710485|NCT00162266|Secondary|Mean Change From Baseline in sIL2-r Over Time in OL Period|Serum evaluations were carried out to determine participant serum levels of sIL2-r. Mean change from baseline=value at post-baseline OL time point-value and baseline OL time point.|Baseline (Day 0) and Days 360, 720, 1080, 1440, and 1800|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.||pg/mL||Standard Error|Mean
710486|NCT00162266|Primary|Number of Participants With Glucose, Protein, Metabolites, and Urinalysis Values Meeting Marked Abnormality Criteria in OL Period||Day 360 to Day 3060|All treated OL participants.||Participants|||Number
710487|NCT00162266|Secondary|Mean Baseline Soluble Serum Interleukin-2 Receptor Level (sIL2-r) Over Time in OL Period|Serum evaluations were carried out to determine participant serum levels of sIL2-r at baseline. Time-matched baseline (Day 0) values and post-baseline vales were presented for each post-baseline visit and represent only that cohort of participants with measurements available at that post-baseline assessment.|Baseline (Day 0) and Days 360, 720,1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.||pg/mL||Standard Deviation|Mean
710488|NCT00162266|Primary|Number of Participants With Electrolyte Values Meeting Marked Abnormality Criteria in OL Period||Day 360 to Day 3060|All treated OL participants.||Participants|||Number
710489|NCT00162266|Primary|Number of Participants With Liver and Kidney Function Values Meeting Marked Abnormality Criteria in OL Period||Day 360 to Day 3060|All treated OL participants.||Participants|||Number
710490|NCT00162266|Primary|Number of Participants With Hematology Values Meeting Marked Abnormality Criteria in OL Period||Day 360 to Day 3060|All treated OL participants.||Participants|||Number
710746|NCT00167778|Secondary|How Bothersome Was Your Pain?|The residual limb pain grade scores ranged from 0 “No Pain/ Interference” to 10 “Severe Pain/Interference.”|Measurements were taken after wearing the study prostheses for four weeks.|10 participants wore both study prostheses but only 7 participants presented with pain.||units on a scale||Standard Error|Mean
710494|NCT00162266|Secondary|Number of Participants With a Clinically Meaningful Improvement on the Modified Health Assessment Questionnaire (mHAQ) in OL Period|The mHAQ is a self-administered questionnaire composed of 20 questions that assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The answers are graded on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The HAQ disease index is a weighted sum of the scale scores, with a higher score indicating poorer function. A clinically meaningful improvement was defined as a reduction from baseline in mHAQ score of at least 0.30 units.|Days 360, 720,1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. N =number of participants analyzed; n=the number of participants with measurements for that time point.||Participants|||Number
710495|NCT00162266|Secondary|Number of ACR 70 Responders in the OL Period|ACR 70 response requires a participant to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in 3 of the following 5 parameters: physician global assessment of disease, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. A participant achieved a sustained ACR 70 response if the participant had ACR 70 observed for at least 2 consecutive study visits.|Days 360, 450, 540, 630, 720, 810, 900, 1080, 1350, 1440, 1530, 1620, 1710, 1800, 1980, 2160, 2340, 2520, 2700, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. N=number of participants analyzed; n=the number of participants with measurements for that time point.||Participants|||Number
710496|NCT00162266|Secondary|Number of ACR 50 Responders in the OL Period|ACR 50 response requires a participant to have a 50% reduction in the number of swollen and tender joints, and a reduction of 50% in three of the following five parameters: physician global assessment of disease, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. A participant achieved a sustained ACR 50 response if the participant had ACR 50 observed for at least 2 consecutive study visits.|Days 360, 450, 540, 630, 720, 810, 900, 1080, 1350, 1440, 1530, 1620, 1710, 1800, 1980, 2160, 2340, 2520, 2700, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. N=number of participants analyzed; n=the number of participants with measurements for that time point.||Participants|||Number
710497|NCT00162266|Secondary|Number of ACR 20 Responders in OL Period|ACR 20 response requires a participant to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in Health Assessment Questionnaire score. A participant achieved a sustained ACR 20 response if the participant had ACR 20 observed for at least 2 consecutive study visits.|Days 360, 450, 540, 630, 720, 810, 900, 1080, 1350, 1440, 1530, 1620, 1710, 1800, 1980, 2160, 2340, 2520, 2700, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the double-blind (DB) study. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Participants|||Number
710498|NCT00162266|Secondary|Pharmacodynamic Measure: Mean Changes From Baseline in Tumor Necrosis Factor (TNF)-Alpha at Day 180 and Day 360||Baseline, Day 180, Day 360|Number of Participants Analyzed=total number of participants in each treatment group. n=number of treated Participants with measurement at baseline and given timepoint.||ng/mL||95% Confidence Interval|Mean
710499|NCT00162266|Secondary|Pharmacodynamic Measure: Mean Changes From Baseline in Soluble Inter-Cellular Adhesion Molecule 1 (sICAM-1) at Day 180 and Day 360||Baseline, Day 180, Day 360|Number of Participants Analyzed=total number of participants in each treatment group. n=number of treated Participants with measurement at baseline and given timepoint.||ng/mL||95% Confidence Interval|Mean
710500|NCT00162266|Secondary|Pharmacodynamic Measure: Mean Changes From Baseline in E-Selectin at Day 180 and Day 360||Baseline, Day 180, Day 360|Number of Participants Analyzed=total number of participants in each treatment group. n=number of treated Participants with measurement at baseline and given timepoint.||ng/mL||95% Confidence Interval|Mean
710501|NCT00162266|Secondary|Pharmacodynamic Measure: Mean Changes From Baseline in Plasma Soluble Interleukin-2 Receptor (sIL-2R) at Day 180 and Day 360||Baseline, Day 180, Day 360|Number of Participants Analyzed=total number of participants in each treatment group. n=number of treated Participants with measurement at baseline and given timepoint.||pg/mL||95% Confidence Interval|Mean
710502|NCT00162266|Secondary|Pharmacodynamic Measure: Mean Changes From Baseline in Interleukin-6 at Day 180 and Day 360||Baseline, Day 180, Day 360|Number of Participants Analyzed=total number of participants in each treatment group. n=number of treated Participants with measurement at baseline and given timepoint.||pg/mL||95% Confidence Interval|Mean
710503|NCT00162266|Secondary|Pharmacodynamic Measure: Mean Changes From Baseline in Rheumatoid Factor at Day 180 and Day 360||Baseline, Day 180, Day 360|Number of Participants Analyzed=total number of participants in each treatment group. n=number of treated Participants with measurement at baseline and given timepoint.||IU/mL||95% Confidence Interval|Mean
710504|NCT00162266|Secondary|Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion(Anti-CTLA4Ig Antibodies Without IG Region)|Number of participants with ratio of VA/PRE <=3, <3 to <=9, and >9. Ratios greater than 9 are incidences of Anti-CTLA4Ig sero-conversion.|Baseline, Days 30, 90, 180, 270, 360|Number of Participants Analyzed=treated participants; n=number of participants with both baseline and post-baseline measurements at timepoint.||participants|||Number
710505|NCT00162266|Primary|Baseline Immunoglobulin M (IgM) Over Time in OL Period|Time-matched baseline (Day 0) values and post-baseline values were presented for each post-baseline visit and represent only that cohort of participants with measurements available at that post-baseline assessment. Mean Change from Baseline data for these cohorts are presented in Outcome Measure 10.|Baseline (Day 0) and Days 360, 720,1080,1440, and 1800|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n=the number of participants with measurements for that time point.||mg/dL||Standard Deviation|Mean
711302|NCT00176865|Primary|Number of Subjects With Mixed Chimerism|>10% Donor Cells at Day 100|Day 100|"Arm 2: 2 of 10 patients not evaluable due to failure to return to clinic for the Day 100 evaluation.
Arm 3: 2 of 6 patients not evaluable due to early death."||participants|||Number
710506|NCT00162266|Primary|Mean Change From Baseline (BL) in IgG Over Time in OL Period|Blood samples for immunoglobulin assessments were obtained to determine change from baseline in serum IgG. Baseline data for these cohorts are presented in Outcome Measure 7.|Baseline (Day 0) and Days 360, 720, 1080, 1440, and 1800|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n=the number of participants with measurements for that time point.||mg/dL||Standard Error|Mean
710507|NCT00162266|Primary|Baseline Immunoglobulin G (IgG) Over Time in OL Period|Time-matched baseline (Day 0) values and post-baseline vales were presented for each post-baseline visit and represent only that cohort of participants with measurements available at that post-baseline assessment. Mean Change from Baseline data for these cohorts are presented in Outcome Measure 8.|Baseline (Day 0) and Days 360, 720, 1080, 1440 and 1800|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n=the number of participants with measurements for that time point.||mg/dL||Standard Deviation|Mean
710508|NCT00162266|Secondary|Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion (Anti-CTLA4Ig Antibodies With IG Region)|Number of participants with ratio of VA/PRE <=3, <3 to <=9, and >9. Ratios greater than 9 are incidences of Anti-CTLA4Ig sero-conversion.|Baseline, Days 30, 90, 180, 270, 360|Number of Participants Analyzed=treated participants; n=number of participants with both baseline and post-baseline measurements at timepoint.||participants|||Number
710509|NCT00162266|Secondary|Immunogenicity Data: Anti-CTLA4Ig Antibodies Without IG Region||Baseline, Days 30, 90, 180, 270, 360|Number of Participants Analyzed=treated participants; n=number of participants with both baseline and post-baseline measurements at timepoint.||titers||Standard Deviation|Geometric Mean
710510|NCT00162266|Secondary|Immunogenicity Data: Anti-CTLA4Ig Antibodies With Immunoglobulin (IG) Region||Baseline, Days 30, 90, 180, 270, 360|Number of Participants Analyzed=treated participants; n=number of participants with both baseline and post-baseline measurements at timepoint.||titers||Standard Deviation|Geometric Mean
710511|NCT00162266|Secondary|Number of Participants Who Discontinued Due to Lack of Efficacy in the DB and OL Periods||Day 1 to Day 360 (Double-Blind Period), Day 361 to Day 3060 (Open-Label Period)|Treated Participants||participants|||Number
710512|NCT00162266|Secondary|Participants With Laboratory Abnormalities Meeting the Marked Abnormality Criteria for Selected Hematologic Values During Double-Blind Therapy||From the start of study up to 60 days post the end of the 12-month double-blind period|Number of Participants Analyzed=All treated participants. n=number of participants evaluated for given measurement.||Participants|||Number
710513|NCT00162266|Primary|Mean Change From Baseline (BL) in IgA Over Time in OL Period|Blood samples for immunoglobulin assessments were obtained to determine change from baseline in serum IgA. Baseline data for these time-matched cohorts are presented in Outcome Measure 5.|Baseline (Day 0) and Days 360, 720, 1080, 1440, and 1800|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n=the number of participants with measurements for that time point.||mg/dL||Standard Error|Mean
710514|NCT00162266|Primary|Baseline Serum Immunoglobulin A (IgA) Over Time in OL Period|Time-matched baseline (Day 0) values and post-baseline values were presented for each post-baseline visit and represent only that cohort of participants with measurements available at that post-baseline assessment. Mean Change from Baseline data for these cohorts are presented in Outcome Measure 6.|Baseline (Day 0) and Days 360, 720,1080, 1440, and 1800|All treated OL participants. Participants were grouped according to the treatment they received in DB study. n=the number of participants with measurements for that time point.||mg/dL||Standard Deviation|Mean
710515|NCT00162266|Primary|Number of Participants With AEs of Special Interest in OL Period|AEs were defined as any new untoward medical occurrence or worsening of a pre- existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest were those which may be associated with the use of immunomodulatory agents or infusion of therapeutic proteins. Acute infusional AEs were defined as those that occurred within 1 hour after the start of the infusion. Peri-Infusional AEs were defined as those that occurred within 24 hours after the start of the infusion.|Day 360 to Day 3060|All treated OL participants.||Participants|||Number
710516|NCT00162266|Primary|Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) in OL Period|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with treatment.SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Related AE/SAE=Certain,Probable,Possible,or Missing relationship to drug.|Day 360 to Day 3060|All treated OL participants.||Participants|||Number
710517|NCT00162266|Primary|Participants Receiving Concomitant Disease Modifying Rheumatic Drugs and Biologics in Open-Label (OL) Period|The number of participants receiving concomitant rheumatoid arthritis treatment with disease modifying rheumatic drugs and/or biologics.|Day 360 to Day 3,060|All treated participants.||Participants|||Number
710518|NCT00162266|Secondary|Participants With Laboratory Abnormalities Meeting the Marked Abnormality Criteria for Selected Blood Chemistry Values During Double-Blind Therapy||From the start of study up to 60 days post the end of the 12-month double-blind period|Number of Participants Analyzed=All treated participants. n=number of participants evaluated for given measurement.||Participants|||Number
710519|NCT00162266|Secondary|Participants Who Experienced Death, Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations During the Double-Blind Period|AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to any AEs were recorded. Related events include those that were considered by the investigator to be certain, probable, or possibly related to study drug.|From the start of study through the end of the double-blind period (at 12 months)|All treated participants||Participants|||Number
710520|NCT00162266|Secondary|Number of Participants With At Least One New Active Joint (Tender Joints and Swollen Joints) at Day 180 and Day 360||Day 180, Day 360|All treated participants||participants|||Number
710521|NCT00162266|Secondary|Adjusted Mean Percent Changes From Baseline in the Modified Health Assessment Questionnaire (mHAQ) at Day 180 and Day 360|A shortened version of the Health Assessment Questionnaire (HAQ), which uses only 8 instead of the 20 original items and is used to assess motor performance in everyday activities, such as dressing, turning a faucet on/off, and getting in and out of a car. Percent change from baseline = (baseline - post baseline value) / baseline value x 100.|Baseline, Day 180, Day 360|Number of Participants Analyzed=total number of participants in each treatment group. n=number of treated Participants with measurement at baseline and given timepoint.||Percentage of Change on mHAQ scale||Standard Error|Mean
710522|NCT00162266|Secondary|Mean Changes From Baseline in the Short Form 36 (SF-36) Physical and Mental Health Component Summary Scores (PCS and MCS) at Day 180 and Day 360|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score.|Baseline, Day 180, Day 360|Number of Participants Analyzed=total number of participants in each treatment group. n=number of treated Participants with measurement at baseline and given timepoint.||units on a scale||Standard Error|Mean
710523|NCT00162266|Secondary|Individual Components of ACR Criteria--Mean Percentage Change From Baseline at Day 360|Percentage change = 100*(Baseline value – value at specific visit) / Baseline value. The American College of Rheumatology (ACR) response criteria, based on a core set of variables which includes a tender joint count, a swollen joint count, patient-reported pain scale (Subject Assessment of Physical Function [SAPF]), patient and physician global assessments of disease activity (Subject Global Assessment [SGA] and Physician Global Assessment [PGA]), patient assessment of functional ability, and an acute phase reactant (C-Reactive Protein [CRP])|Baseline, Day 360|Number of Participants Analyzed = Participants who received at least 1 infusion of study medication; n = subset of participants who had given measurement at both time points.||percentage change||Standard Error|Mean
710524|NCT00162266|Secondary|Individual Components of ACR Criteria--Mean Percentage Change From Baseline at Day 180|Percentage change = 100*(Baseline value – value at specific visit) / Baseline value. The American College of Rheumatology (ACR) response criteria, based on a core set of variables which includes a tender joint count, a swollen joint count, patient-reported pain scale (Subject Assessment of Physical Function [SAPF]), patient and physician global assessments of disease activity (Subject Global Assessment [SGA] and Physician Global Assessment [PGA]), patient assessment of functional ability, and an acute phase reactant (C-Reactive Protein [CRP])|Baseline, Day 180|Number of Participants Analyzed = Participants who received at least 1 infusion of study medication; n = subset of participants who had given measurement at both time points.||percentage change||Standard Error|Mean
710525|NCT00162266|Secondary|ACR-N Area Under The Curve (AUC) on Day 180 and Day 360|The AUC for ACR-N is the measure of the area under the curve of the mean change from baseline in ACR-N. The trapezoidal rule was used to compute the AUC. The ACR-N AUC was compared between the two abatacept treatment groups and the placebo group using an analysis of variance (ANOVA) for 6- and 12-month data (Day 180 and Day 360). This allowed for the assessment of subject response throughout the study. See Measure Description in Outcome Measure 18 for a definition of ACR-N.|Baseline and Day 180; Baseline and Day 360|||percentage*days||Standard Error|Mean
710526|NCT00162266|Secondary|ACR Numeric Values (ACR-N)|The ACR-N is calculated for each participant by taking the lowest percentage improvement in (1) swollen joint count or (2) tender joint count or (3) the median of the remaining 5 components of the ACR response (participant’s assessment of disease activity; participant’s global assessment of pain; physician’s assessment of disease activity; participant’s assessment of physical function; an acute phase reactant value - CRP). Negative numbers indicate worsening.|Day 15; Day 30; Day 60; Day 90; Day 120; Day 150; Day 180; Day 240; Day 300; Day 360|Participants who received at least 1 infusion of study medication||units on a scale||Standard Deviation|Mean
710527|NCT00162266|Secondary|Number of ACR 70 Responders in DB Period|ACR 70 response requires a participant to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. A participant achieved a sustained ACR 70 response if the participant had ACR 70 observed for at least 2 consecutive study visits.|Day 15; Day 30; Day 60; Day 90; Day 120; Day 150; Day 180; Day 240; Day 300; Day 360|Participants who received at least 1 infusion of study medication||Participants|||Number
710528|NCT00162266|Secondary|Number of ACR 50 Responders in DB Period|ACR 50 response requires a participant to have a 50% reduction in the number of swollen and tender joints, and a reduction of 50% in three of the following five parameters: physician global assessment of disease, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. A participant achieved a sustained ACR 50 response if the participant had ACR 50 observed for at least 2 consecutive study visits.|Day 15; Day 30; Day 60; Day 90; Day 120; Day 150; Day 180; Day 240; Day 300; Day 360|Participants who received at least 1 infusion of study medication||Participants|||Number
710529|NCT00162266|Secondary|Number of ACR 20 Responders in DB Period|ACR 20 response requires a participant to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. A participant achieved a sustained ACR 20 response if the participant had ACR 20 observed for at least 2 consecutive study visits.|Days 15, 30, 60, 90, 120, 150,180, 240, 300, and 360|Participants who received at least 1 infusion of study medication||Participants|||Number
710558|NCT00162942|Secondary|Mean Change in Work Limitations Questionnaire (Output Demands)|101-point, ordinal scale which measures the degree to which health problems interfere with certain aspects of job performance and productivity from 0 (limited none of the time) to 100 (limited all the time), Mean change=Week 12 Mean -Baseline Mean|Baseline to Week 12|All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis. The week 12 score or Last Observation Carried Forward was used for the analysis.||units on a scale||Standard Deviation|Mean
710530|NCT00162266|Primary|Number of Responders to American College of Rheumatology 20% Improvement Criteria (ACR 20) at Day 180 of the Double-Blind (DB) Period|ACR 20 response requires a participant to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in Health Assessment Questionnaire score. A participant achieved a sustained ACR 20 response if the participant had ACR 20 observed for at least 2 consecutive study visits.|Day 180|Intent-to-treat population. Participants who discontinued the study due to lack of efficacy (ie, worsening rheumatoid arthritis) were considered ACR 20 nonresponders at all subsequent time points. For all subjects who discontinued for other reasons, their last ACR 20 response was carried forward.||Participants|||Number
710531|NCT00162370|Secondary|Determine the Cost-effectiveness of Using Stress Echocardiography in Screening Peri- and Post-menopausal Women at Intermediate Risk for Coronary Artery Disease.||End of Study||||||
710532|NCT00162370|Secondary|Determine the Relative Values of Exercise Echocardiography, Exercise ECG Testing, Cardiac Peptides and Brachial Artery Reactivity for Identifying Patients at Risk of Cardiac Events.||End of Study||||||
710533|NCT00162370|Secondary|Determine the Value of Brachial Artery Reactivity for Identifying Patients With Cardiac Events During Follow-up.||End of Study||||||
710534|NCT00162370|Secondary|Determine the Value of Exercise Induced Changes in Levels of Cardiac Peptides; Brain Natriuretic Peptide (BNP) in Identifying Patients With Cardiac Events During Follow-up.||2 year or 5 year follow up||||||
710535|NCT00162370|Secondary|Percent of Subjects With Abnormal Stress ECG Testing for Identifying Patients With Major Adverse Cardiac Events (MACE)|Stress ECG test interpretation will be summarized using number and percentage of patients with normal and abnormal ECG with and without MACE|2 or 5 year follow up|Subject has received a physical exam, completed patient history profile, undergone the protocol-specific unenhanced and DEFINITY enhanced rest and stress echocardiography, had the necessary blood work for the study and 2 and/or 5 year follow up||percent of MACE|||Number
710536|NCT00162370|Primary|Percentage of Low to Intermediate Risk Patients Experiencing Future Major Adverse Cardiac Events (MACE)|Determine the prognostic value of stress echocardiography as a screening examination in peri- or post-meopausal female patients with an intermediate pre-test likelihood of coronary artery disease (CAD) to identify patients at higer risk of experiencing future cardiac events.|2 or 5 year follow up|Subject has received a physical exam, completed patient history profile, undergone the protocol-specific unenhanced and DEFINITY enhanced rest and stress echocardiography, had the necessary blood work for the study and 2 and/or 5 year follow up||% of subjects with MACE|||Number
710537|NCT00162773|Primary|Changes in Free Serum IgE Levels From Baseline||baseline to 2 weeks|Data, if any, are not available as this study has been terminated as the PI has left the institution. The arms/groups were combined for the study due to the study's early termination and the PI's departure from the institution. Data obtained were from the IRB and are therefore not separated by arm. This is all that is available.|||||
710538|NCT00156247|Secondary|Percent of Patients Achieving a PGA of Clear or Almost Clear at 6 Months After the Addition of Acitretin Therapy|Percentage of participants achieving a clear (0) or almost clear (1) status on the Physician Global Assessment (PGA) at 6 months. This index evaluates the physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The assessment was scored on a scale of 0 to 5, where 0 = clear, with no evidence of plaque elevation, erythema, or scale, and 5 = severe induration, erythema, and scaling.|6 months|||percent|||Number
710539|NCT00156247|Secondary|Percent of Patients Achieving PASI 50 at 6 Months After the Addition of Acitretin Therapy|Percentage of participants achieving at least a 50% decrease (improvement) from Baseline in the Psoriasis Area and Severity Index (PASI) at 6 months. PASI Score incorporates measures of erythema, desquamation, infiltration, and affected body surface area. Involvement and severity of psoriasis was scored using a scale of 0 to 72, where 0 = no psoriasis and 72 = severe disease.|6 months|||percent|||Number
710540|NCT00156247|Primary|Percent of Patients Achieving PASI 75 at 6 Months After the Addition of Acitretin Therapy|Percentage of participants achieving at least a 75% decrease (improvement) from Baseline in the Psoriasis Area and Severity Index (PASI) at 6 months. PASI Score incorporates measures of erythema, desquamation, infiltration, and affected body surface area. Involvement and severity of psoriasis was scored using a scale of 0 to 72, where 0 = no psoriasis and 72 = severe disease.|6 months|||percent|||Number
710541|NCT00156390|Secondary|Echocardiographic Improvement||1 year||||||
710542|NCT00156390|Primary|Minnesota For Living With Heart Failure Questionnaire|"Quality of Life Questionnaire List of 21 Questions; each question has a Scale 0-5 with 0 = no heart failure did not prevent one from living as they want and 5= yesheart failure prevented one very much from living as they want. Overall scores between 0-105, with 105 being the worse quality of life."|1 year|||units on a scale||Standard Deviation|Mean
710543|NCT00156533|Secondary|Wake After Sleep Onset (WASO)|Number of subjects with any reduction in WASO at post-tx compared to baseline where mean WASO = mean of daily values for one week calculated from sleep diary values.|Baseline and Post-Treatment (12 weeks)|Completers||participants|||Number
710544|NCT00156533|Primary|Sleep Latency (SL)|Number of subjects with any reduction in SL (time to fall asleep in minutes)at post-tx compared to baseline where mean SL = mean of daily values for one week calculated from sleep diary values.|Baseline and Post-treatment (12wks)|Completers Only||participants|||Number
710545|NCT00156715|Secondary|Clinical Symptoms|The main outcome measure of clinical symptoms was the Positive and Negative Symptoms Scale. This is a 30 item scale for assessing patients diagnosed with schizophrenia. Each item is rated on a 1 (absent) to 7 (extreme) scale. The minimum total score is 30 and the maximum is 210.|12 Weeks|Only those participants who received at least 4 weeks of treatment with quetiapine were included in this analysis. Site differences resulted in only the 11 participants from Site 1 to be included in this analysis. Participants from Site 2 were all admitted to the study directly from the hospital, which could have affected their behavior.||Units on a scale||Standard Deviation|Mean
710601|NCT00165698|Secondary|Bone Biomarker Undercarboxylated Osteocalcin (UCOC) Percentage Change After 12 Months||Baseline and 12 months|Per Protocol Set (PPS)||percentage of UCOC||Inter-Quartile Range|Median
710602|NCT00165698|Secondary|Bone Biomarker Osteocalcin (OC) Percentage Change After 12 Months||Baseline and 12 months|Per Protocol Set (PPS)||percentage of OC||Inter-Quartile Range|Median
710546|NCT00156715|Primary|Mean Number of Drinking Days Per Week|Timeline Follow-back (TLFB) procedure was used at screening and baseline to establish current substance use, and it was also used weekly during the course of the study to assess continued alcohol and other substance use. TLFB cosisted of using a calendar and sasking participants to report alcohol and other drug use since last visit. At the screening visit, the TLFB was done for the four weeks prior to the visit.|12 Weeks|Only those participants who received at least 4 weeks of treatment with quetiapine were included in this analysis. Site differences resulted in only the 11 participants from Site 1 to be included in the analysis. Participants from Site 2 were all admitted to the study directly from the hospital which could have affected their alcohol consumption.||Drinking Days per Week||Standard Deviation|Mean
710547|NCT00156819|Primary|Treatment Failure|The primary outcome measure was treatment failure, defined as the occurrence of any one of the following events: hospitalization or an urgent medical visit for asthma initiated by the patient or physician; use of systemic corticosteroids for asthma or need for open-label use of inhaled corticosteroids for asthma, as determined by the study physician or an asthma care provider; a decrease in prebronchodilator forced expiratory volume in 1 second (FEV1) to more than 20% below the baseline value measured at randomization; a decrease in the morning peak expiratory flow rate to more than 35% below the baseline value (the mean over the final 2 weeks of the run-in period) on 2 consecutive days; use of 10 puffs or more per day of rescue beta-agonist for 2 consecutive days (except as medication before exercise); refusal of the patient to continue because of lack of satisfaction with treatment; or judgment by a physician that the patient should stop treatment for reasons of safety.|16 weeks|||participants|||Number
710548|NCT00162942|Post-Hoc|Clinical Response Based on no Use of 5-Aminosylisalates During the Study|A clinical response is defined as a 70-point decrease in CDAI score|Baseline to Week 12|All subjects who received at least one apheresis treatment session and who did not use 5-aminosylisalates during the study were included in the analysis population. The week 12 CDAI score was used for the analysis. Subjects without a week 12 CDAI score or subjects with a major violation on prohibited medications were considered a treatment failure.||percentage of participants|||Number
710549|NCT00162942|Post-Hoc|Clinical Response Based on Use of 5-Aminosylisalates During the Study|A clinical response is defined as a 70-point decrease in CDAI score|Baseline to Week 12|All subjects who received at least one apheresis treatment session and who used 5-aminosylisalates during the study were included in the analysis population. The week 12 CDAI score was used for the analysis. Subjects without a week 12 CDAI score or subjects with a major violation on prohibited medication were considered a treatment failure.||percentage of participants|||Number
710550|NCT00162942|Post-Hoc|Clinical Response Based on No Previous Use of Tumor Necrosis Factor-Alpha (TNF-a) Inhibitors|A clinical response is defined as a 70-point decrease in CDAI score|Baseline to Week 12|All subjects who received at least one apheresis treatment session and who have not used TNFa-inhibitors were included in the analysis population. The week 12 CDAI score was used for the analysis. Subjects without a week 12 CDAI score or subjects with a major violation on prohibited medications were considered a treatment failure.||percentage of participants|||Number
710551|NCT00162942|Post-Hoc|Clinical Response Based on Previous Use of Tumor Necrosis Factor-Alpha (TNF-a) Inhibitors|A clinical response is defined as a 70-point decrease in CDAI score|Baseline to Week 12|All subjects who received at least one apheresis treatment session and previously used TNFa-inhibitors were included in the analysis population. The week 12 CDAI score was used for the analysis. Subjects without a week 12 CDAI score or subjects with a major violation on prohibited medications were considered a treatment failure.||percentage of participants|||Number
710552|NCT00162942|Post-Hoc|Clinical Response in Subjects With a CDAI Score Less Than or Equal to 300|A clinical response is defined as a 70-point decrease in CDAI score|Baseline to Week 12|All subjects who received at least one apheresis treatment session and had a CDAI score less than or equal to 300 at baseline were included in the analysis population. The week 12 CDAI score was used for the analysis. Subjects without a week 12 CDAI score or with a major violation on prohibited medications were considered a treatment failure.||percentage of participants|||Number
710553|NCT00162942|Post-Hoc|Clinical Response in Subjects With a CDAI Score Greater Than 300|A clinical response is defined as a 70-point decrease in CDAI score.|Baseline to Week 12|All subjects who received at least one apheresis treatment session and had a CDAI score greater than 300 at baseline were included in the analysis population. The week 12 CDAI score was used for the analysis. Subjects without a week 12 CDAI score or subjects with a major violation on prohibited medications were considered a treatment failure.||percentage of participants|||Number
710554|NCT00162942|Secondary|Mean Change in C-Reactive Protein||Baseline to week 12|All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis. The week 12 value or Last Observation Carried Forward was used for the analysis.||milligrams/liter||Standard Deviation|Mean
710555|NCT00162942|Secondary|Mean Change in Subject Global Rating|7-point,ordinal scale that measures the subject's state of Crohn's Disease from 0 (totally inactive) to 7 (as bad as it gets), Mean change=Week 12 Mean -Baseline Mean|Baseline to Week 12|All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis. The week 12 score or Last Observation Carried Forward was used for the analysis.||units on a scale||Standard Deviation|Mean
710556|NCT00162942|Secondary|Mean Change in Crohn's Disease Endoscopic Index of Severity|26-point,ordinal scale that assesses the severity of Crohn's Disease from 0 (least severe) to 26 (most severe), Mean change=Week 12 Mean -Baseline Mean|Baseline to Week 12|Endoscopic evaluations were to be performed at baseline and Week 12 on a subset of study subjects.||units on a scale||Standard Deviation|Mean
710557|NCT00162942|Secondary|Mean Change in Work Limitations Questionnaire (WLQ Index)|101-point, ordinal scale which measures the degree to which health problems interfere with certain aspects of job performance and productivity from 0 (limited none of the time) to 100 (limited all the time), Mean change=Week 12 Mean -Baseline Mean|Baseline to Week 12|All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis. The week 12 score or Last Observation Carried Forward was used for the analysis.||units on a scale||Standard Deviation|Mean
710603|NCT00165698|Secondary|Bone Mineral Content BMC (Percentage) Change in Collum Femoris After 12 Months||Baseline and 12 months|Per Protocol Set (PPS)||percentage of BMC||Full Range|Median
710559|NCT00162942|Secondary|Mean Change in Work Limitations Questionnaire (Mental-Interpersonal Demands)|101-point, ordinal scale which measures the degree to which health problems interfere with certain aspects of job performance and productivity from 0 (limited none of the time) to 100 (limited all the time), Mean change=Week 12 Mean -Baseline Mean|Baseline to Week 12|All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis. The week 12 score or Last Observation Carried Forward was used for the analysis.||units on a scale||Standard Deviation|Mean
710560|NCT00162942|Secondary|Mean Change in Work Limitations Questionnaire (Physical Demands)|101-point, ordinal scale which measures the degree to which health problems interfere with certain aspects of job performance and productivity from 0 (limited none of the time) to 100 (limited all the time), Mean change=Week 12 Mean -Baseline Mean|Baseline to Week 12|All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis. The week 12 score or Last Observation Carried Forward was used for the analysis.||units on a scale||Standard Deviation|Mean
710561|NCT00162942|Secondary|Mean Change in Work Limitations Questionnaire (Time Management)|101-point, ordinal scale which measures the degree to which health problems interfere with certain aspects of job performance and productivity from 0 (limited none of the time) to 100 (limited all the time), Mean change=Week 12 Mean -Baseline Mean|Baseline to Week 12|All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis. The week 12 score or Last Observation Carried Forward was used for the analysis.||units on a scale||Standard Deviation|Mean
710562|NCT00162942|Secondary|Mean Change in EuroQol Score (Visual Analog Scale)|101-point, ordinal scale which measures non-disease specific health-related quality of life from 0 (Worst imaginable health state) to 100 (best imaginable health state)|Baseline to Week 12|All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis. The week 12 score or Last Observation Carried Forward was used for the analysis.||units on a scale||Standard Deviation|Mean
710563|NCT00162942|Secondary|Mean Change in EuroQol Score (Single Index)|A continuous scale that is a cardinal index of health from 0 (no impairment) to 1 (most impairment), Mean change=Week 12 Mean -Baseline Mean|Baseline to Week 12|All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis. The week 12 score or Last Observation Carried Forward was used for the analysis.||units on a scale||Standard Deviation|Mean
710564|NCT00162942|Secondary|Mean Change in Inflammatory Bowel Diseases Questionnaire (IBDQ)|193-point, ordinal scale measuring disease-specific quality of life from 32 (low quality of life) to 224 (high quality of life). Mean change= Week 12 Mean-Baseline Mean|Baseline to Week 12|All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis. The week 12 score or Last Observation Carried Forward was used for the analysis.||units on a scale||Standard Deviation|Mean
710565|NCT00162942|Secondary|Mean Change in Short-Form 36 Questionnaire (SF-36) Mental Component Summary (MCS) Score|101-point, ordinal scale measuring general health of patients from 0 (low quality of life) to 100 (high quality of life), Mean change=Week 12 Mean -Baseline Mean|Baseline to Week 12|All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis. The week 12 score or Last Observation Carried Forward was used for the analysis.||units on a scale||Standard Deviation|Mean
710566|NCT00162942|Secondary|Mean Change in Short-Form 36 Questionnaire (SF-36) Physical Component Summary (PCS) Score|101-point, ordinal scale measuring general health of patients from 0 (low quality of life) to 100 (high quality of life), Mean change=Week 12 Mean -Baseline Mean|Baseline to Week 12|All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis. The week 12 score or Last Observation Carried Forward was used for the analysis.||units on a scale||Standard Deviation|Mean
710567|NCT00162942|Secondary|Clinical Response|Clinical Response is defined as a ≥ 100-point reduction in the CDAI scores at Week 12|Baseline to Week 12|All subjects who received at least one apheresis session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis. The week 12 CDAI score or Last Observation Carried Forward was used for the analysis. Subjects with a major violation on prohibited medications were considered a treatment failure.||percentage of participants|||Number
710568|NCT00162942|Secondary|CDAI Score Change From Baseline|601-point, ordinal scale which quantifies the symptoms of patients with Crohn's Disease from 0 (complete remission) to 600 (most severe active disease). Mean change=Week 12 Mean CDAI-Baseline Mean CDAI|Baseline to Week 12|All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis. The week 12 score was used for the analysis. If no week 12 score, then the week 9 score was be used. If no week 9 score, the subject was considered a treatment failure.||units on a scale||Standard Deviation|Mean
710569|NCT00162942|Primary|Frequency and Severity of Adverse Events Through Week 12|All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis.|Baseline through Week 12 Visit|All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis.||percentage of participants|||Number
710570|NCT00162942|Primary|Clinical Remission|Clinical Remission is defined as a Crohn's Disease Activity Index (CDAI) score of ≤150 when evaluated at Week 12|Baseline to Week 12|All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT was used for effectiveness analysis. The week 12 CDAI score was used for the analysis. Subjects without a week 12 CDAI score or with a major violation on prohibited medications were considered a treatment failure.||percentage of participants|||Number
710604|NCT00165698|Secondary|Bone Mineral Content BMC (Percentage) Change in Lumber Spine After 12 Months||Baseline and 12 months|Per Protocol Set (PPS)||percentage of BMC||Full Range|Median
710605|NCT00165698|Primary|Bone Mineral Density BMD (Percentage) Change in Trochiter After 12 Months||Baseline and 12 months|Per Protocol Set (PPS)||percentage of BMD||Full Range|Median
710571|NCT00162981|Secondary|Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms.|"The parent/caregiver was asked to rate the patient's overall change in symptoms and overall change in seizure activity and Quality of Life since the beginning of clobazam treatment by checking very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse."|Week 7|MITT population, baseline evaluations compared to Week 7 evaluations.||participants|||Number
710572|NCT00162981|Primary|A Comparison of the High Dose Group to Low Dose Group of the Percent Reduction in Number of Drop Seizures.|Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal.|4-week baseline period and the 4-week maintenance period|MITT population||Percent Reduction||Full Range|Median
710573|NCT00162981|Secondary|Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms.|"The parent/caregiver was asked to rate the patient's overall change in symptoms and overall change in seizure activity and Quality of Life since the beginning of clobazam treatment by checking very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse."|Week 3|MITT population, baseline evaluations compared to Week 3 evaluations.||participants|||Number
710574|NCT00162981|Secondary|Percent of Patients Considered Treatment Responders Defined as Those With a >= 25%, >= 50%, >= 75%, and 100% Reduction in Drop Seizures.|Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal.|4-week baseline period and 4-week maintenance period|||Percent of participants|||Number
710575|NCT00162981|Primary|Percent Reduction in Number of Drop Seizures.|Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal.|4-week baseline period and 4-week maintenance period|Modified Intention-to-Treat (MITT) populations consist of all randomized patients who received study medication and who have both a baseline and post-baseline measurement and have at least one measurement during the maintenance period.||Percent Reduction||Standard Deviation|Mean
710576|NCT00163020|Primary|Perinatal Death|Perinatal death within the twin group is described as a stillbirth, neonatal death, or miscarriage after randomization.|measured from randomization to 28 days after birth.|Population analysed were total Twin infants delivered to mothers within each study arm. (ie. babies born to moms in active arm (320) vs. babies born to mothers in placebo arm(156))||Twins|||Number
710577|NCT00163020|Secondary|Participant Side Effects Requiring Cessation of Therapy|Describe as the cessation of study related therapy for the participant within the twin group at anytime from initial study related injection until the final injection at 34 weeks of pregnancy.|anytime from initial injection to final injection at 34 weeks.|Population analysed were total pregnant mothers (participants) with twin gestation (ie. active group 160 and placebo group 80)||participants|||Number
710578|NCT00163020|Secondary|Participant Drop-out Rates|Drop-out rates in the twin group are described as any randomized participant who is withdrawn from the trial between randomization (as early at 16 weeks of pregnancy) and completion of the final dose of study medication (as late as 34 weeks of pregnancy).|any time from randomization to completion of final dose of study medication|Population analysed were total pregnant mothers (participants) with twin gestation (ie. active group 160 and placebo group 80)||participants|||Number
710579|NCT00163020|Secondary|Newborn Birthweight|Newborn Birthweight within the twins group was measure following delivery and noted in grams.|measure following delivery|Population analysed were twins from twin pregnancies (ie. active group 160 and placebo group 80)||grams||Standard Deviation|Mean
710580|NCT00163020|Secondary|Newborn Gestational Age (GA) at Delivery|Newborn Gestational age at delivery within the twin group is described as the gestational age of the baby on the day of birth.|determined at the time of birth|Population analysed were total pregnant mothers with twin gestations (ie. active group 160 and placebo group 80)||weeks of age for twin pregnancy||Standard Deviation|Mean
710581|NCT00163020|Secondary|Triplets: Delivery Prior to 28 Wks, 32 Wks, 35 Wks|Gestational age was noted at time of delivery and stratified into three categories (Triplets: Delivery prior to 28 wks, 32 wks, 35 wks)|noted at delivery|Population analysed were total pregnant mothers with triplet gestations (ie. active group 160 and placebo group 80)||Triplet Pregnancies|||Number
710582|NCT00163020|Secondary|Twins: Delivery Prior to 28 Weeks (Wks), 32 Wks, 34wks, and 37 Wks|Gestational age was noted at time of delivery and stratified into three categories (Twins: Delivery prior to 28 weeks (wks), 32 wks, 34 wks, and 37 wks)|Gestational age noted at time of birth|Population analysed were total pregnancies of mothers with twin gestation (ie. active group 160 and placebo group 80)||Twin Pregnancies|||Number
710583|NCT00163020|Secondary|Individual Components of Neonatal Morbidity (RDS, IVH-III/IV, Bronchopulmonary Dysplasia(BPD), PVL, Sepsis, NEC, ROP-Stage 3/4, Perinatal Death)|Composite Neonatal Morbidity within the twin group is described as the presence of any one or more of the following neonatal morbidities (RDS, IVH-III/IV, BPD, PVL, sepsis, NEC, ROP-Stage 3/4, Perinatal Death).|measured as any event noted in the first 28 day following birth.|Population analysed were total Twin infants delivered to mothers within each study arm. (ie. babies born to moms in active arm (320) vs. babies born to mothers in placebo arm(155))||Twins - Components of Neonatal Morbidity|||Number
710584|NCT00163020|Primary|Newborn Asphyxia With Ischemic Injury of Brain, Heart, Kidneys, or Liver|Newborn Asphyxia or Hypoxic-ischemic encephalopathy (HEI) within the twin group is characterized by clinical and laboratory evidence of acute or subacute brain injury due to asphyxia (ie, hypoxia, acidosis).|measured during the first 28 days after delivery|Population analysed were total Twin infants delivered to mothers within each study arm. (ie. babies born to moms in active arm (274) vs. babies born to mothers in placebo arm(130))||Twins|||Number
710585|NCT00163020|Primary|Newborn Retinopathy of Prematurity (ROP)|Newborn ROP within the twin group is described as retinopathy confirmed on fundoscopic examination, felt to be due to prematurity and subsequent oxygen therapy.|measured during the first 28 day after birth|Population analysed were total Twin infants delivered to mothers within each study arm. (ie. babies born to moms in active arm (308) vs. babies born to mothers in placebo arm(145))||Twins|||Number
711303|NCT00176878|Secondary|Number of Patients With Disease Recurrence|Number of patients who exhibited disease recurrence at 2 years.|2 years|||Participants|||Number
710586|NCT00163020|Primary|Newborn Necrotizing Enterocolitis (NEC)Requiring Surgery|Newborn NEC in the twin group is described as the presence of any of the following: (1)unequivocal intramural air in abdominal radiograph; (2) perforation abdominal radiograph; (3) clinical evidence of perforation (erythema and induration of the abdominal wall or intrabdominal abscess formation); (4) characteristic findings observed at surgery or autopsy; (5) Stricture formation after an episode of suspected necrotizing enterocolitis.|measured in the first 28 days after birth|Population analysed were total Twin infants delivered to mothers within each study arm. (ie. babies born to moms in active arm (315) vs. babies born to mothers in placebo arm(152))||Twins|||Number
710587|NCT00163020|Primary|Newborn Periventricular Leukomalacia (PVL)|Newborn Periventricular leukomalacia (PVL) in the twin group is described as the presence of more than 1 obvious hypo echoic cyst in the periventricular white matter.|measured in the first 28 days after birth.|The participants were randomized in a two to one fashion (2=active participants to every 1=placebo participant). The number of participants for analysis was determined using an intention to treat protocol.||participants|||Number
710588|NCT00163020|Primary|Newborn Intraventricular Hemorrhage Grade 3 or 4|"Newborn Intraventricular hemorrhage (IVH) Stage III in the twin group is described as - IVH with ventricular dilatation.
Neonatal Intraventricular hemorrhage (IVH)Stage IV in the twin group is described as - IVH with parenchymal extension."|measured during the first 28 days after birth|Population analysed were total Twin infants delivered to mothers within each study arm. (ie. babies born to moms in active arm (316) vs. babies born to mothers in placebo arm(152))||Twins|||Number
710589|NCT00163020|Primary|Newborn Pneumonia|Newborn Pneumonia in the twin group is described as compatible symptoms with diagnostic radiograph findings and positive results on blood cultures, persistent leukopenia|measure during the first 28 days after birth.|Population analysed were total Twin infants delivered to mothers within each study arm. (ie. babies born to moms in active arm (320) vs. babies born to mothers in placebo arm(154))||Twins|||Number
710590|NCT00163020|Primary|Newborn Sepsis|Newborn Sepsis in the twin group was defined as the presence of positive blood culture obtained in the first week of life in association with clinical findings suggesting illness for which the neonate received antibiotics.|measured during the first week following birth|The participants were randomized in a two to one fashion (2=active participants to every 1=placebo participant). The number of participated included were based on an intent to treat protocol.||participants|||Number
710591|NCT00163020|Primary|Use of Oxygen Therapy at 28 Days of Newborn Life|Supplemental oxygen use by the baby measured at the point that the baby reaches 28 days old (after birth)within the twin group.|Measured at 28 days after birth.|Population analysed were total Twin infants delivered to mothers within each study arm. (ie. babies born to moms in active arm (308) vs. babies born to mothers in placebo arm(150))||Twins|||Number
710592|NCT00163020|Primary|Newborn Respiratory Distress Syndrome (RDS)|"Newborn RDS in the twin arm is defined as compatible symptoms with radiographically confirmed hyaline membrane disease or with respiratory insufficiency of prematurity requiring ventilator support.
Data expressed as mean n(%),Odds ratio, CI, and P-value were determined using repeated measures model wherein each twin/triplet within a given pregnancy is considered a repeated measure. Exceptions are comparison with 0 outcomes in one or both groups, so Fisher’s Exact Test was used.
Morbidity measures were based on live births with data available for the outcomes."|Measured from delivery until 30 days after baby was discharged from the hospital|Population analysed were total Twin infants delivered to mothers within each study arm. (ie. babies born to moms in active arm (319) vs. babies born to mothers in placebo arm(153))||Twins|||Number
710593|NCT00163657|Primary|Freedom From HCV Recurrence Within First Year That Requires HCV Antiviral Therapy and Freedom From Treatment Failure|Participants would have their blood drawn and tested for the HCV virus to determine if they had recurrence|12 month post transplant|||participants|||Number
710594|NCT00163657|Primary|Freedom From Acute Rejection or HCV Recurrence or Treatment Failure|"Freedom from acute rejection (Banff>grade 2 with RAI score>4) or freedom from HCV recurrence (Batts/Ludwig>Stage 2, or >Grade 3) that requires HCV antiviral therapy or treatment failure (patient death, graft loss, premature withdrawal from study regimen or treatment with more than 1 dose of corticosteroids for presumptive rejection without a biopsy to confirm the rejection; reported values represent the Number of participants with Freedom From Acute Rejection or HCV Recurrence or Treatment Failure"|12 months|||participants|||Number
710595|NCT00165503|Primary|Adjuvant Chemotherapy Completion Rate|Feasibility in this study was based on the adjuvant chemotherapy regimen. The chemotherapy completion rate is defined as the percentage of patients who complete 3 cycles of cisplatin and Alimta beginning 6-10 weeks after surgery with hyperthermic cisplatin.|Given the 21-day cycle, 3 cycles of adjuvant chemotherapy approximates 9 weeks in addition to the time from registration and post-surgery which was up to 10 weeks.|None of the enrolled participants were evaluated for the primary endpoint since none received the experimental adjuvant chemotherapy per protocol.|||||
710596|NCT00165646|Primary|Percentage of Participants With Complete Relief of Heartburn at Final Evaluation|“Heartburn diary” will be given to each subject and ask him/her to keep the diary every day throughout the study period. The subject will be requested to record the occurrence of heartburn during the daytime and the nighttime in the diary. Primary End Point is the rate of complete disappearance of heartburn. The rate of heartburn do not occur in the past week will be calculated based on the diary. Participants were evaluated at week 4 about episodes of heartburn in the last 7 days|4 weeks|The major endpoint of this study was between-group comparison of the complete relief of heartburn (at the completion of the treatment period) in the full analysis set (FAS).||Percentage of participants|||Number
710597|NCT00165672|Primary|The Percent Time With pH <4.0 During 24 Hour Esophageal pH Monitoring at the End of the Observation Period (Predose Monitoring) and at the End of the Treatment Period (Postdose Monitoring).|Mean and standard deviation of percent time pH<4.0 on 24 hour esophageal pH monitoring.|Baseline and 4 weeks|The major endpoint of this study was analysed in the population for clinical pharmacology data (observation period and treatment period)||Percent Time||Standard Deviation|Mean
710598|NCT00165698|Secondary|Height (Meter)||Baseline and 12 months|Per Protocol Set (PPS)||meters||Standard Deviation|Mean
710599|NCT00165698|Secondary|New Fracture and Fall||12 months|Per Protocol Set (PPS)||participants|||Number
710600|NCT00165698|Secondary|Bone Biomarker Undercarboxylated Osteocalcin/Osteocalcin (UCOC/OC) Percentage Change After 12 Months||Baseline and 12 months|Per Protocol Set (PPS)||percentage of UCOC/OC||Inter-Quartile Range|Median
710608|NCT00165776|Secondary|Mean Change From Baseline in Patient Pain Assessment (VAS) at Week 4 After Treatment|Change from Baseline in Patient's Pain Assessment-VAS is computed as Week 4 value minus baseline value. A negative value in change from baseline indicates an improvement. The patient's assessment of pain was performed using a 100 mm VAS)ranging from no pain (0) to unbearable pain (100). The distance in mm from the left edge of the scale was measured. A negative change from Baseline score indicates improvement in pain intensity.|Baseline, Week 4|FAS||Millimeters||Standard Error|Mean
710609|NCT00165776|Secondary|Mean Change From Baseline in the TWSTRS - Severity Score at Week 4 After Treatment|TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.|Baseline, Week 4|FAS||Points on a Scale||Standard Error|Mean
710610|NCT00165776|Secondary|Mean Change From Baseline in the TWSTRS - Pain Score at Week 4 After Treatment|TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.|Baseline, Week 4|FAS||Points on a Scale||Standard Error|Mean
710611|NCT00165776|Secondary|Mean Change From Baseline in the TWSTRS - Functional Disability Score at Week 4 After Treatment|TWSTRS-Disability score which ranges from 0 (=no disability)to 30 (=maximum disability). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.|Baseline, Week 4|FAS||Points on a Scale||Standard Error|Mean
710612|NCT00165776|Primary|Mean Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Treatment|"The TWSTRS-Total score is the sum of scores of the three components of the scale:
TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity)
TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain)
TWSTRS-Disability score which ranges from 0 (=no disability) to 30 (=maximum disability).
The TWSTRS total score ranges from 0 (=best value) to 85 (=worst value). The change from baseline was calculated as the score at the corresponding visit minus the baseline score."|Baseline, Week 4|Full Analysis Set (FAS) population: All subjects who received study treatment||Points on a Scale||Standard Error|Mean
710613|NCT00165776|Secondary|Mean Change From Baseline in Physician Global Assessment Disease Assessment - Visual Analog Scale (PGA-VAS) at Week 4 After Treatment|Change from Baseline in PGA-VAS (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as Week 4 value minus baseline value. A negative value in change from baseline indicates an improvement.|Baseline, Week 4|FAS||Millimeters||Standard Error|Mean
710614|NCT00165776|Secondary|Mean Change From Baseline in Patient Global Assessment - Visual Analog Scale (PtGA-VAS) at Week 4 After Treatment|"Change from Baseline in PtGA-VAS is computed as Week 4 value minus baseline value. A negative value in change from baseline indicates an improvement. Participants answered: Considering all the ways your cervical dystonia affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly."|Baseline, Week 4|FAS||Millimeters||Standard Error|Mean
710615|NCT00165789|Primary|Number of Participants With Any TEAE|Treatment-emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that started on or after the first dose of study medication until the end of the study. Information on any AEs were recorded throughout the study after informed consent had been signed and included abnormal clinical laboratory tests, vital sign measurements and physical examinations. Note: Safety/tolerability info captured in Adverse Event section.|Through end of study|Safety Population was the primary population for analysis defined as all subjects who completed the Baseline Phase and who received at least 1 dose of double-blind study medication.||Participants|||Number
710616|NCT00165789|Secondary|Duration of Dyskinesia From UPDRS at Baseline and Day 70|The duration of dyskinesia was determined from question 32 (part 4) of the UPDRS assessment. It asks what proportion of the waking day are dyskinesias present, and uses a 5-part scale: 0 = None, 1 = 1-25% of day, 2 = 26-50% of day, 3 = 51-75% of day, 4 = 76-100% of day. Lower scores represented more normal functioning.|Baseline and Day 70|Safety Population||Participants|||Number
710617|NCT00165789|Secondary|Disability of Dyskinesia From UPDRS at Baseline and Day 70|The disability of dyskinesia was determined from question 33 (part 4) of the UPDRS assessment. It asks how disabling are the dyskinesias, and uses a 5-part scale: 0=Not disabling, 1=MIldly disabling, 2=Moderately disabling, 3=Severely disabling, 4=Completely disabling. Lower scores represented more normal functioning.|Baseline and Day 70|Safety Population||Participants|||Number
710618|NCT00165789|Secondary|"Change From Baseline to Day 70 in Percent on Time With Non-troublesome Dyskinesias"|"Subjects and/or caregiver completed a diary recording their motor state and dyskinesia symptoms over the course of the day before and at the end of study drug dosing on 3 consecutive days leading up to Baseline and Day 70. An entry was made every 30 minutes whether they were in the on state experiencing troubling dyskinesias or off state. The on state reflected recovery of control of a particular Parkinsonian feature that readily responded to each dose of levodopa, while the off state reflected the re-emergence of that feature. Troublesome dyskinesias were unintentional movements that occurred while in the on state and which interfered with activities or caused discomfort to any extent."|Baseline and Day 70|Safety Population. Change from Baseline only reflect participants who completed the assessment at Baseline and Day 70.||Percentage of the Day||Standard Deviation|Mean
710619|NCT00165789|Secondary|"Change From Baseline to Day 70 in Percent on Time"|"Subjects and/or caregiver completed a diary recording their motor state and dyskinesia symptoms over the course of the day before and at the end of study drug dosing on 3 consecutive days leading up to Baseline and Day 70. An entry was made every 30 minutes whether they were in the on state experiencing troubling dyskinesias or off state. The on state reflected recovery of control of a particular Parkinsonian feature that readily responded to each dose of levodopa, while the off state reflected the re-emergence of that feature. Troublesome dyskinesias were unintentional movements that occurred while in the on state and which interfered with activities or caused discomfort to any extent."|Baseline and Day 70|Safety Population. Change from Baseline only reflect participants who completed the assessment at Baseline and Day 70.||Percentage of the Day||Standard Deviation|Mean
710747|NCT00167778|Secondary|Pain Interference With Activities?|The residual limb pain grade scores ranged from 0 “No Pain/ Interference” to 10 “Severe Pain/Interference.”|Measurements were taken after wearing the study prostheses for four weeks.|10 participants wore both study prostheses but only 7 participants presented with pain.||units on a scale||Standard Error|Mean
710620|NCT00165789|Secondary|"Change From Baseline to Day 70 in Percent Off Time"|"Subjects and/or caregiver completed a diary recording their motor state and dyskinesia symptoms over the course of the day before and at the end of study drug dosing on 3 consecutive days leading up to Baseline and Day 70. An entry was made every 30 minutes whether they were in the on state experiencing troubling dyskinesias or off state. The on state reflected recovery of control of a particular Parkinsonian feature that readily responded to each dose of levodopa, while the off state reflected the re-emergence of that feature. Troublesome dyskinesias were unintentional movements that occurred while in the on state and which interfered with activities or caused discomfort to any extent."|Baseline and Day 70|Safety Population. Change from Baseline only reflect participants who completed the assessment at Baseline and Day 70.||Percentage of the Day||Standard Deviation|Mean
710621|NCT00165789|Secondary|Change From Baseline to Day 70 in Goetz/Rush Score|The Goetz/Rush scale was used to rate severity during performance of tasks intended to elicit dyskinesias, and provided an objective rating of dyskinesias during activities of daily living.The tasks included a sitting exercise, mental calculations, drinking, dressing, and walking. A 5-point scale was used: 0=absent; 1=minimal severity, no interference with voluntary motor acts; 2=dyskinesias, may impair voluntary movements but the subject was capable of efficiently completing the motor task; 3=intense dyskinesias, interference with movement control and completion of the motor task was greatly limited; 4= violent dyskinesias, incompatible with the completion of the motor task. A lower score indicated less difficulty performing the tasks.|Baseline and Day 70|Safety Population. Change from Baseline only reflect participants who completed the assessment at Baseline and Day 70.||Scores on a Scale||Standard Deviation|Mean
710622|NCT00165789|Secondary|"Change From Baseline to Day 70 in Absolute on Time With Troublesome Dyskinesias"|"Subjects and/or caregiver completed a diary recording their motor state and dyskinesia symptoms over the course of the day before and at the end of study drug dosing on 3 consecutive days leading up to Baseline and Day 70. An entry was made every 30 minutes whether they were in the on state experiencing troubling dyskinesias or off state. The on state reflected recovery of control of a particular Parkinsonian feature that readily responded to each dose of levodopa, while the off state reflected the re-emergence of that feature. Troublesome dyskinesias were unintentional movements that occurred while in the on state and which interfered with activities or caused discomfort to any extent."|Baseline and Day 70|Safety Population. Change from Baseline only reflect participants who completed the assessment at Baseline and Day 70.||Hours||Standard Deviation|Mean
710623|NCT00165789|Secondary|"Change From Baseline to Day 70 in Absolute on Time With Non-troublesome Dyskinesias"|"Subjects and/or caregiver completed a diary recording their motor state and dyskinesia symptoms over the course of the day before and at the end of study drug dosing on 3 consecutive days leading up to Baseline and Day 70. An entry was made every 30 minutes whether they were in the on state experiencing troubling dyskinesias or off state. The on state reflected recovery of control of a particular Parkinsonian feature that readily responded to each dose of levodopa, while the off state reflected the re-emergence of that feature. Troublesome dyskinesias were unintentional movements that occurred while in the on state and which interfered with activities or caused discomfort to any extent."|Baseline and Day 70|Safety Population. Change from Baseline only reflect participants who completed the assessment at Baseline and Day 70.||Hours||Standard Deviation|Mean
710624|NCT00165789|Secondary|"Change From Baseline to Day 70 in Absolute Off Time"|"Subjects and/or caregiver completed a diary recording their motor state and dyskinesia symptoms over the course of the day before and at the end of study drug dosing on 3 consecutive days leading up to Baseline and Day 70. An entry was made every 30 minutes whether they were in the on state experiencing troubling dyskinesias or off state. The on state reflected recovery of control of a particular Parkinsonian feature that readily responded to each dose of levodopa, while the off state reflected the re-emergence of that feature. Troublesome dyskinesias were unintentional movements that occurred while in the on state and which interfered with activities or caused discomfort to any extent."|Baseline and Day 70|Safety Population. Change from Baseline only reflect participants who completed the assessment at Baseline and Day 70.||Hour||Standard Deviation|Mean
710625|NCT00165789|Secondary|"Change From Baseline to Day 70 in on State of UPDRS Scores"|The Unified Parkinson's Disease Rating Scale (UPDRS) consisted of 4 subsections used to assess symptoms and signs of Parkinson's disease, with an overall scale range of 0-147. Individual subsections included: I. Mentation, behavior, and mood (0-16); II. Activities of daily living assessed in both the “on” and “off” state (0-52); III. Motor examination (0-56); and IV. Complications of therapy assessed in the “on” fluctuations and dyskinesias (0-23). Each subsection included subscales that ranged from 0 (best possible outcome) to 1 or 4 (worst possible outcome), with the total score of subsection equaling the sum of the scores of the subscales and the overall UPDRS score equaling the sum of the scores of the 4 subsections (higher score indicating more severe Parkinson's Disease).|Baseline and Day 70|Safety Population. Change from Baseline only reflect participants who completed the assessment at Baseline and Day 70.||Scores on a Scale||Standard Deviation|Mean
710626|NCT00165841|Secondary|The Percent of Heartburn-free Nighttime Period During the 6-month Maintenance Treatment Phase|The percentage of heartburn-free nighttime period is presented cumulatively including all data collected during the 6-month|6-month maintenance phase||||||
710627|NCT00165841|Secondary|The Percent of Heartburn-free Daytime Period During the 6-month Maintenance Treatment Phase|The percentage of heartburn-free daytime period is presented cumulatively including all data collected during the 6-month Maintenance Phase|6-month maintenance phase||||||
710628|NCT00165841|Primary|The Percentage of Heartburn-free Days (24-hour Periods) During the 6-month Maintenance Treatment Phase (ITT Population).|The percentage of heartburn-free days during the 6-month Maintenance Treatment Phase in patients treated with rabeprazole 20 mg compared to patients who received placebo in the ITT Population. Heartburn-free day was defined as no heartburn in both the daytime and nighttime period on a given day. Note a total 388 subjects were enrolled at the beginning of Acute Phase and 200 subjects were enrolled into the double-blind 6-month maintenance treatment phase.|6 months double-blind maintenance phase|Intent-to-treat (ITT) population, total 187 subjects, was used for efficacy analyses. Safety population (total 200 subjects) was used for safety analysis and participant flow.||Percentage of Days||Standard Deviation|Mean
710629|NCT00165958|Primary|Number of Participants With Cyst Recurrence|Recurrence of cyst after removal|16 months|||participants|||Number
710630|NCT00165984|Primary|Survival|Follow-up study designed to determine the impact of genetic factors on survival in single ventricle patients|7 yr mean follow-up|All patients enrolled were genotyped||percentage of patients alive/nontrans|||Number
710632|NCT00159861|Secondary|Change From Baseline in BORG Dyspnea Score|BORG Dyspnea score: change from core study Baseline. Subject rating of maximum degree of dyspnea experienced at any time during the 6-Minute Walk Test. Range: 0 (no breathlessness at all) to 10 (maximum breathlessness).|Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Month 9, Month 12, Month 15, Month 18, Month 21, Month 24, Month 27, Month 30, Month 33, Month 36|FAS. N=number of subjects with evaluable data at core study Baseline; n=number of subjects with evaluable data at observation, Placebo, Sildenafil, respectively. Treatment groups shown by core study randomization; includes subjects who were only treated in the core study and those who continued into the extension study.||scores on scale||Full Range|Median
710633|NCT00159861|Secondary|Change From Baseline in Medical Outcomes Study Short Form 36 (SF-36): Reported Health Transition Score|Subject-rated measure of health status (36 items): 8 subscale scores (physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, mental health), 2 summary scores (physical component, mental component), and a self-evaluated change in health status. Change from Baseline in SF-36 Health Transition score at each visit. I=much better than 1 year ago; II=somewhat better than 1 year ago; III=about the same as 1 year ago; IV=somewhat worse than 1 year ago; V=much worse than 1 year ago|Baseline, Month 15, Month 27, Month 39|FAS. N=number of subjects with evaluable data at core study Baseline. Treatment groups shown by core study randomization; includes subjects who who were only treated in the core study and those continued into the extension study. BL=Baseline.||participants|||Number
710634|NCT00159861|Secondary|Change From Baseline in European Quality of Life (EuroQol) Visual Analogue Scale (EQ-5D VAS): Current Health State Score|EQ-5D: subject rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.|Baseline, Month 15, Month 27, Month 39|FAS. N=number of subjects with evaluable data at core study Baseline; n=number of subjects with evaluable data at observation, Placebo, Sildenafil, respectively. Treatment groups shown by core study randomization; includes subjects who who were only treated in the core study and those continued into the extension study.||scores on scale||95% Confidence Interval|Mean
710635|NCT00159861|Secondary|Change From Baseline in European Quality of Life Scale (EuroQol) 5-Dimensions (EQ-5D): Utility Index Score|EQ-5D: subject rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Month 15, Month 27, Month 39|FAS. N=number of subjects with evaluable data at core study Baseline; n=number of subjects with evaluable data at observation, Placebo, Sildenafil, respectively. Treatment groups shown by core study randomization; includes subjects who who were only treated in the core study and those who continued into the extension study.||scores on scale||95% Confidence Interval|Mean
710636|NCT00159861|Secondary|Change From Baseline in Medical Outcomes Study Short Form 36 (SF-36)|Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health), 2 summary scores (physical component and mental component), and a self-evaluated change in health status. Subscale and summary scores range: 0-100. Higher subscale and summary scores = better health status. Change from baseline = score at observation minus score at baseline.|Baseline, Month 15, Month 27, Month 39|FAS. N=number of subjects with evaluable data at core study Baseline; n=number of subjects with SF-36 score at observation, Placebo, Sildenafil, respectively. Treatment groups shown by core study randomization; includes subjects who who were only treated in the core study and those who continued into the extension study. Phys = physical.||scores on scale||95% Confidence Interval|Mean
710637|NCT00159861|Secondary|Change in Pulmonary Hypertension Criteria for Functional Capacity and Therapeutic Class|Pulmonary hypertension (PH) criteria: Class I: PH without limitation of physical activity (PA) (no undue dyspnea, fatigue, chest pain, near syncope); Class II: PH with slight limitation in PA, comfortable at rest, ordinary PA causes undue dyspnea, fatigue, chest pain, near syncope; Class III: PH with marked limitation in PA, comfortable at rest, less than ordinary activity causes undue dyspnea, fatigue, chest pain or syncope; Class IV: PH with inability to carry out PA without symptoms, signs of right heart failure, dyspnea or fatigue may be present at rest, discomfort increased by any PA.|1 Year, 2 Year, 3 Year|FAS; N=number of subjects with evaluable data at core study Baseline. Treatment groups shown by core study randomization; includes subjects in core study and in extension study. Scores for categorized changes for missing visits imputed as worse score of its non-missing neighbors; missing visits with no subsequent score: score coded to missing.||participants|||Number
710638|NCT00159861|Primary|Categorized Change From Baseline in 6-Minute Walking Distance|Number of subjects with categorized change in 6-minute walking distance. Distance that a subject could walk in 6-minutes at a comfortable pace with as many breaks as needed. Performed as close to trough levels of sildenafil as possible (just before dosing; at least 4 hours after the previous dose of study drug). Scores for categorized changes for missing visits were imputed as the worse score of its non-missing neighbors. If a visit was missing and there was no subsequent score, the score was coded to missing.|1 Year, 2 Year, 3 Year|FAS. m = meters. N=number of subjects with evaluable data at core study Baseline. Treatment groups shown by core study randomization; includes subjects who were only treated in the core study and those who continued into the extension study.||participants|||Number
710639|NCT00159861|Secondary|Survival Status|Yearly survival status: number of subjects who survived, discontinued, and died. Analysis includes post-treatment visit data from subjects who discontinued study treatment. Time to death was taken relative to the first dose of study treatment in A1481141, and was censored on the last day the subject was known to be alive in A1481141 or A1481153.|1, 2, 3, 4, and 5 years|Full analysis set: all randomized and treated subjects recruited into core study. N=number of subjects with evaluable data at core study Baseline.||participants|||Number
711399|NCT00178464|Secondary|# of Subjects Recruited Over Time, Screening Failures, Withdrawal Rates;Compliance (Pill Counts & Labs);Changes in Performance on Neurocognitive Tests; Changes in MRI/MRA; Changes in TCD;Incidences of Stroke, Acute Chest Crises, and Pain Crises||12 months||||||
710640|NCT00159861|Other Pre-specified|Change in Epoprostenol Dose From Baseline Maintained for 6 Months|Number of subjects with changes in Epoprostenol dose from baseline maintained continuously for 6 months. Increased = Epoprostenol dose continuously more than 20% greater than core study Baseline for at least 6 months. Decrease = Epoprostenol dose continuously more than 20% less than core study Baseline for at least 6 months. No change = Epoprostenol dose change met neither Increase or Decrease criteria. Stopped = Epoprostenol dose stopped for at least 6 months.|Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Month 9, and at 3-month intervals through Month 69|Safety population: all subjects who took at least one dose of study medication in core study. N=number of subjects with evaluable data at core study Baseline. Includes subjects who were only treated in the core study and those who continued into the extension study.||participants|||Number
710641|NCT00159874|Secondary|Physician Global Assessment at Year 1|The physician global assessment of disease severity was assessed at Year 1 in this extension study. The number and percentage of participants with markedly improved, moderately improved, mild improvement, no change, slightly worse, moderately worse, markedly worse were evaluated. Participants who withdrew from study treatment after at least 10 weeks of treatment were requested to perform the global assessments.|Year 1|An ITT population included all randomly assigned participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline.||Participants|||Number
710642|NCT00159874|Secondary|Participant (Parent) Global Assessment at Year 1|The participant (parent) global assessment of disease severity was assessed at Year 1 in this extension study. The number and percentage of participants markedly improved, moderately improved, mild improvement, no change, slightly worse, moderately worse, markedly worse were evaluated. Participants who withdrew from study treatment after at least 10 weeks of treatment were requested to perform the global assessments.|Year 1|An ITT population included all randomly assigned participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline.||Participants|||Number
710643|NCT00159874|Secondary|Change From Baseline in Child Health Questionnaire-Parent Form (CHQ-PF28) as Assessed by the Physical Scale at Year 1.|CHQ: 50-item, 15 subscale parent or legal guardian assessed instrument of child's physical, emotional, social well-being, and relative burden of disease on the parents; rated on Likert-type scale: range 0 to 100; higher scores indicate a more positive health status. Global indicators for Physical Health and Psychosocial Health are weighted composites derived from subscale items using scoring algorithms (transformed scores); range 0 to 100: higher scores indicate more positive health status.|Baseline, Year 1|ITT population included all randomized participants who took at least 1 dose of study drug in base study; certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4, 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline. Participants >= 5 years at baseline with questionnaire translated were included.||Units on a scale||Standard Deviation|Mean
710644|NCT00159874|Secondary|Change From Baseline in Child Health Questionnaire-Parent Form (CHQ-PF28) as Assessed by the Psychosocial Scale at Year 1.|CHQ: 50-item, 15 subscale parent or legal guardian assessed instrument of child's physical, emotional, social well-being, and relative burden of disease on the parents; rated on Likert-type scale: range 0 to 100; higher scores indicate a more positive health status. Global indicators for Physical Health and Psychosocial Health are weighted composites derived from subscale items using scoring algorithms (transformed scores); range 0 to 100: higher scores indicate more positive health status.|Baseline, Year 1|ITT population included all randomized participants who took at least 1 dose of study drug in base study; certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4, 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline. Participants >= 5 years at baseline with questionnaire translated were included.||Units on a scale||Standard Deviation|Mean
710645|NCT00159874|Secondary|Additions From Baseline in Background Therapy up to the End of Study|This was defined as an addition or discontinuation in the class(es) of drugs used as background medication (e.g., anticoagulants, oxygen, diuretics, calcium channel blockers, and digoxin) compared to baseline of Study A1481131 (NCT00159913).|Up to the end of study|An ITT population included all randomly assigned participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline.||Participants|||Number
710646|NCT00159874|Secondary|Summary of Shift in Changes From Start of Sildenafil in WHO PH Functional Class by A1481156 Treatment Group at Year 4.|The WHO PH functional classification was as follows: Class I : Participants with PH but without resulting limitation of physical activity. Class II : Participants with PH resulting in slight limitation of physical activity. Class III : Participants with PH resulting in marked limitation of physical activity. Class IV : Participants with PH with inability to carry out any physical activity without symptoms. Changes from baseline in functional class were summarised at Years 1, 2, 3, and 4. Numbers of participants improving by 3 classes, improving by 2 classes, improving by 1 class, not changing, worsening by 1 class, worsening by 2 classes or worsening by 3 classes from A1481131 baseline at Years 1, 2, 3 and 4 were evaluated.|Baseline, Year 4|An ITT population included all randomly assigned participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline.||Participants|||Number
710647|NCT00159874|Secondary|Summary of Shift in Changes From Start of Sildenafil in WHO PH Functional Class by A1481156 Treatment Group at Year 3.|The WHO PH functional classification was as follows: Class I : Participants with PH but without resulting limitation of physical activity. Class II : Participants with PH resulting in slight limitation of physical activity. Class III : Participants with PH resulting in marked limitation of physical activity. Class IV : Participants with PH with inability to carry out any physical activity without symptoms. Changes from baseline in functional class were summarised at Years 1, 2, 3, and 4. Numbers of participants improving by 3 classes, improving by 2 classes, improving by 1 class, not changing, worsening by 1 class, worsening by 2 classes or worsening by 3 classes from A1481131 (NCT00159913) baseline at Years 1, 2, 3 and 4 were evaluated.|Baseline, Year 3|An ITT population included all randomized participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline.||Participants|||Number
710648|NCT00159874|Secondary|Summary of Shift in Changes From Start of Sildenafil in WHO PH Functional Class by A1481156 Treatment Group at Year 2.|The WHO PH functional classification was as follows: Class I : Participants with PH but without resulting limitation of physical activity. Class II : Participants with PH resulting in slight limitation of physical activity. Class III : Participants with PH resulting in marked limitation of physical activity. Class IV : Participants with PH with inability to carry out any physical activity without symptoms. Changes from baseline in functional class were summarised at Years 1, 2, 3, and 4. Numbers of participants improving by 3 classes, improving by 2 classes, improving by 1 class, not changing, worsening by 1 class, worsening by 2 classes or worsening by 3 classes from A1481131 baseline at Years 1, 2, 3 and 4 were evaluated.|Baseline, Year 2|An ITT population included all randomly assigned participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline.||Participants|||Number
710649|NCT00159874|Secondary|Summary of Shift in Changes From Start of Sildenafil in World Health Organization Pulmonary Hypertension (WHO PH) Functional Class by A1481156 Treatment Group at Year 1.|The WHO PH functional classification was as follows: Class I : Participants with PH but without resulting limitation of physical activity. Class II : Participants with PH resulting in slight limitation of physical activity. Class III : Participants with PH resulting in marked limitation of physical activity. Class IV : Participants with PH with inability to carry out any physical activity without symptoms. Changes from baseline in functional class were summarized at Years 1, 2, 3, and 4. Numbers of participants improving by 3 classes, improving by 2 classes, improving by 1 class, not changing, worsening by 1 class, worsening by 2 classes or worsening by 3 classes from A1481131 baseline at Years 1, 2, 3 and 4 were evaluated.|Baseline, Year 1|An ITT population included all randomly assigned participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline.||Participants|||Number
710650|NCT00159874|Secondary|Percentage Change From Baseline in Anaerobic Threshold at Year 1.|Exercise Tolerance Test (CPX test) was performed on developmentally able participants to measure the anaerobic threshold at Week 16 and Year 1. Participants were assumed to be developmentally able if they had a CPX exercise assessment at any visit during study A1481131 (NCT00159913). The CPX tests were performed as close to trough plasma levels of sildenafil as possible, i.e., prior to dosing and at least 4 hours after the previous dose. If participants were able to perform the CPX test in Study A1481131 (NCT00159913), they were expected to be able to perform the exercise paradigm in the extension study (A1481156) unless their clinical condition had deteriorated and the investigator considered this was unsafe for the participant.|Baseline, Year 1|An ITT population included all randomized participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline. Only developmentally able participants were used for this analysis.||Percent||Standard Deviation|Mean
710651|NCT00159874|Secondary|Percentage Change From Baseline in End Tidal Carbon Dioxide (CO2) at Year 1.|Exercise Tolerance Test (CPX test) was performed on developmentally able participants to measure the End Tidal CO2 at Year 1. Participants were assumed to be developmentally able if they had a CPX exercise assessment at any visit during study A1481131 (NCT00159913). The CPX tests were performed as close to trough plasma levels of sildenafil as possible, i.e., prior to dosing and at least 4 hours after the previous dose. If participants were able to perform the CPX test in Study A1481131 (NCT00159913), they were expected to be able to perform the exercise paradigm in the extension study (A1481156) unless their clinical condition had deteriorated and the investigator considered this was unsafe for the participant.|Baseline, Year 1|An ITT population included all randomized participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline. Only developmentally able participants were used for this analysis.||Percent||Standard Deviation|Mean
710652|NCT00159874|Secondary|Percentage Change From Baseline in End Tidal Oxygen (O2) at Year 1.|Exercise Tolerance Test (CPX test) was performed on developmentally able participants to measure the End Tidal O2 at Year 1. Participants were assumed to be developmentally able if they had a CPX exercise assessment at any visit during study A1481131 (NCT00159913). The CPX tests were performed as close to trough plasma levels of sildenafil as possible, i.e., prior to dosing and at least 4 hours after the previous dose. If participants were able to perform the CPX test in Study A1481131 (NCT00159913), they were expected to be able to perform the exercise paradigm in the extension study (A1481156) unless their clinical condition had deteriorated and the investigator considered this was unsafe for the participant.|Baseline, Year 1|An ITT population included all randomized participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline. Only developmentally able participants were used for this analysis.||Percent||Standard Deviation|Mean
710653|NCT00159874|Secondary|Percent Change From Start of Sildenafil in Total Ventilation (VE) to Year 1|Exercise Tolerance Test (CPX test) was performed on developmentally able participants to determine the total ventilation. Participants were assumed to be developmentally able if they had a CPX exercise assessment at any visit during study A1481131 (NCT00159913). The CPX tests were performed as close to trough plasma levels of sildenafil as possible, i.e., prior to dosing and at least 4 hours after the previous dose. If participants were able to perform the CPX test in Study A1481131 (NCT00159913), they were expected to be able to perform the exercise paradigm in the extension study (A1481156) unless their clinical condition had deteriorated and the investigator considered this was unsafe for the participant.|Year 1|An ITT population included all randomized participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline. Only developmentally able participants were used for this analysis.||Percent||Standard Deviation|Mean
710748|NCT00167778|Secondary|Least Residual Limb Pain?|The residual limb pain grade scores ranged from 0 “No Pain/ Interference” to 10 “Severe Pain/Interference.”|Measurements were taken after wearing the study prostheses for four weeks.|10 participants wore both study prostheses but only 7 participants presented with pain.||units on a scale||Standard Error|Mean
710654|NCT00159874|Secondary|Percent Change From Baseline in Respiratory Exchange Ratio at Year 1|This is the ratio of carbon dioxide (CO2) produced to O2 consumed [VCO2/VO2]. Exercise Tolerance Test was performed on developmentally able participants to determine the respiratory exchange ratio on week 16 and Year 1. Participants were assumed to be developmentally able if they had a CPX exercise assessment at any visit during study A1481131 (NCT00159913).|Baseline, Year 1|An ITT population included all randomized participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline. Only developmentally able participants were used for this analysis.||Percent||Standard Deviation|Mean
710655|NCT00159874|Secondary|Percent Change From Baseline in Time to Maximum VO2 at Year 1|Exercise Tolerance Test (CPX test) was performed on developmentally able participants to determine the time to maximum VO2. Participants were assumed to be developmentally able if they had a CPX exercise assessment at any visit during study A1481131 (NCT00159913). The CPX tests were performed as close to trough plasma levels of sildenafil as possible, i.e., prior to dosing and at least 4 hours after the previous dose. If participants were able to perform the CPX test in Study A1481131 (NCT00159913), they were expected to be able to perform the exercise paradigm in the extension study (A1481156) unless their clinical condition had deteriorated and the investigator considered this was unsafe for the participant.|Baseline, Year 1|An ITT population included all randomized participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline. Only developmentally able participants were used for this analysis.||Percent||Standard Deviation|Mean
710656|NCT00159874|Secondary|Percentage Change From Baseline in Percent Predicted Peak VO2 at Year 1.|Exercise Tolerance Test (CPX test) was performed on developmentally able participants to measure the percent predicted peak VO2 at Week 16 and Year 1. Participants were assumed to be developmentally able if they had a CPX exercise assessment at any visit during study A1481131 (NCT00159913). The CPX tests were performed as close to trough plasma levels of sildenafil as possible, i.e., prior to dosing and at least 4 hours after the previous dose. If participants were able to perform the CPX test in Study A1481131 (NCT00159913), they were expected to be able to perform the exercise paradigm in the extension study (A1481156) unless their clinical condition had deteriorated and the investigator considered this was unsafe for the participant.|Baseline, Year 1|An ITT population included all randomized participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline. Only developmentally able participants were used for this analysis.||Percent||Standard Deviation|Mean
710657|NCT00159874|Secondary|Peak Volume of Oxygen (VO2) Consumed at Year 1 Using a Bicycle Ergometry Cardiopulmonary Exercise Test (CPX)|Exercise Tolerance Test (CPX test) was performed on developmentally able participants to determine the peak volume of VO2 consumed. Participants were assumed to be developmentally able if they had a CPX exercise assessment at any visit during study A1481131 (NCT00159913). The CPX tests were performed as close to trough plasma levels of sildenafil as possible, i.e., prior to dosing and at least 4 hours after the previous dose. If participants were able to perform the CPX test in Study A1481131 (NCT00159913), they were expected to be able to perform the exercise paradigm in the extension study (A1481156) unless their clinical condition had deteriorated and the investigator considered this was unsafe for the participant|1 year|An ITT population included all randomized participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline. Only developmentally able participants were used for this analysis.||mL/kg/min||Standard Deviation|Mean
710658|NCT00159874|Primary|Pediatric Motor Development Status at Week 52|Participant's motor development status was assessed at Week 52 using the physician assessment questions. Assessment question (i.e., compared to other children the participant’s age group is this participant’s motor development limited?) included the following criteria : severely limited, moderately limited, mildly limited and not limited.|Week 52|Safety population included all randomly assigned participants who took at least 1 dose of study medication in Study A1481131 (NCT00159913). Participants with observed data were included in table.||Participants|||Number
710659|NCT00159874|Primary|Pediatric Motor Development Status at Week 16.|Participant's motor development status was assessed at A1481156 baseline (Week 16 in A1481131; NCT00159913) using the physician assessment questions. Assessment question (i.e., compared to other children the participant’s age group is this participant’s motor development limited?) included the following criteria : severely limited, moderately limited, mildly limited and not limited.|Week 16|Safety population included all randomly assigned participants who took at least 1 dose of study medication in Study A1481131 (NCT00159913). Participants with observed data were included in table.||Participants|||Number
710660|NCT00159874|Primary|Pediatric Cognitive Development Status at Week 52.|Participant's cognitive development status was assessed at Week 52 using the physician assessment questions. Assessment question (i.e., compared to other children the participant’s age group is this participant’s cognitive development limited?) included the following criteria : severely limited, moderately limited, mildly limited and not limited.|Week 52|Safety population included all randomly assigned participants who took at least 1 dose of study medication in Study A1481131 (NCT00159913). Participants with observed data were included in table.||Participants|||Number
710661|NCT00159874|Primary|Pediatric Cognitive Development Status at Week 16.|Participant's cognitive development status was assessed at A1481156 baseline (Week 16 in A1481131; NCT00159913) using the physician assessment questions. Assessment question (i.e., compared to other children the participant’s age group is this participant’s cognitive development limited?) included the following criteria : severely limited, moderately limited, mildly limited and not limited.|Week 16|Safety population included all randomly assigned participants who took at least 1 dose of study medication in Study A1481131 (NCT00159913). Participants with observed data were included in table.||Participants|||Number
710749|NCT00167778|Secondary|Worst Residual Limb Pain?|The residual limb pain grade scores ranged from 0 “No Pain/ Interference” to 10 “Severe Pain/Interference.”|Measurements were taken after wearing the study prostheses for four weeks.|10 participants wore both study prostheses but only 7 participants presented with pain.||units on a scale||Standard Error|Mean
710662|NCT00159874|Primary|Number of Participants With Deterioration Post Baseline in Color Vision Monitoring Safety Tests.|Colour vision was measured where appropriate via the Farnsworth-Munsell D-15 Hue test. This test was performed in both eyes simultaneously or just in a single specific eye. If using a single eye the same eye was used throughout the study. In case of young participants an age-and-ability-appropriate evaluation such as the Ishihara Test for Unlettered Persons were conducted.|Week 36|Safety population included all randomly assigned participants who took at least 1 dose of study medication in Study A1481131 (NCT00159913).||Participants|||Number
710663|NCT00159874|Primary|Number of Participants With Deterioration Post Baseline in Visual Acuity Safety Tests|Visual Acuity is measured either using the reduced Snellen test or via Teller cards, and was assessed in the left and right eyes separately. There were 9 lines on the reduced Snellen chart which were coded as 6/60, 6/36, 6/24, 6/18, 6/12, 6/9, 6/6, 6/5, 6/4 (where 6/60 was the easiest to read and 6/4 was the most difficult to read). If a participant experienced a visual adverse event the investigator was asked to perform additional ocular assessments either at the visit when the participant reported the visual adverse event or at an unplanned visit.|Week 36|Safety population included all randomly assigned participants who took at least 1 dose of study medication in Study A1481131 (NCT00159913).||Participants|||Number
710664|NCT00159874|Primary|Downtitration in Dose Due to Intolerability.|Based on review of the survival data, DMC concluded that the high dose of sildenafil was associated with a harmful effect on survival when compared to the low dose. The DMC also expressed concern as to the potential dose-response relationship between increasing dose and mortality. Therefore, on 04 August 2011, the DMC recommended discontinuation of the 40 mg and 80 mg three times a day (TID) doses, as well as the 20 mg TID dose in children with body weight ≤20 kg. The protocol was amended per DMC recommendations.|Pre-DMC recomendation (04 August 2011)|Safety population included all randomly assigned participants who took at least 1 dose of study medication in Study A1481131 (NCT00159913).||Participants|||Number
710665|NCT00159874|Primary|Discontinuation Due to Intolerability|Participant who experienced drug-related intolerance, the participant’s dose was reduced by 50%. If, after a dose reduction, the participant continued to appear intolerant, they were discontinued from study treatment.|Throughout the treatment duration (median treatment duration 1689 to 1744 days)|Safety population included all randomly assigned participants who took at least 1 dose of study medication in Study A1481131 (NCT00159913).||Participants|||Number
710666|NCT00159874|Primary|Number of Deaths Reported During This Study|Deaths were reported immediately independent of the circumstances or suspected cause at any time during the study through the last follow-up visit or 30 days after the last administration of study drug, whichever comes later.|Last follow-up visit or 30 days after the last administration of study drug|The safety population consisted of all participants who had taken at least one dose of study medication in A1481131 (NCT00159913).||Participants|||Number
710667|NCT00159874|Primary|Number of Deaths Reported in the Study Prior to the Data Monitoring Committee (DMC) Recommendation of Dose Down Titration|Deaths were reported immediately independent of the circumstances or suspected cause at any time during the study through the last follow-up visit or 30 days after the last administration of study drug, whichever comes later.|Pre-DMC Recommendation dose down titration (04 August 2011)|The safety population consisted of all participants who had taken at least one dose of study medication in A1481131 (NCT00159913).||Participants|||Number
710668|NCT00159874|Primary|Number of Participants Reporting Treatment-related Serious Adverse Events|All serious adverse events regardless of treatment group or suspected relationship to study drug were reported. Investigators were to provide independent determination of possible causality of any serious adverse event.|Up to Follow-Up visit (30 to 40 days after study completion or treatment discontinuation)|The safety population consisted of all participants who had taken at least one dose of study medication in A1481131 (NCT00159913).||Participants|||Number
710669|NCT00159874|Primary|Number of Participants Reporting at Least One Serious Adverse Event|Safety was measured according to standard adverse event collection as described in the adverse event section of the results. Complete tables of the serious adverse events according to the A1481156 treatment groups are provided in the reported adverse event section.|Up to Follow-Up visit (30 to 40 days after study completion or treatment discontinuation)|The safety population consisted of all participants who had taken at least one dose of study medication in A1481131 (NCT00159913).||Participants|||Number
710670|NCT00159874|Primary|Number of Participants Reporting Treatment-related Adverse Events|Safety was measured according to standard adverse event collection as described in the adverse event section of the results.|Up to Follow-Up visit (30 to 40 days after study completion or treatment discontinuation)|The safety population consisted of all participants who had taken at least one dose of study medication in A1481131 (NCT00159913).||Participants|||Number
710671|NCT00159874|Primary|Number of Participants Reporting at Least One Adverse Event|Safety was measured according to standard adverse event collection as described in the adverse event section of the results. Complete tables of the adverse events according to the A1481156 treatment groups are provided in the reported adverse event section.|Up to Follow-Up visit (30 to 40 days after study completion or treatment discontinuation)|The safety population consisted of all participants who had taken at least one dose of study medication in A1481131 (NCT00159913).||Participants|||Number
710672|NCT00159913|Primary|Percent Change From Baseline in Peak Volume of Oxygen (VO2) Consumed : Per Protocol Population|Peak VO2 (normalized for body weight) at trough plasma levels assessed by CPX testing (bicycle ergometry)at the end of treatment (Week 16 for those who completed the study). Mean Percent change = [(week 16 value minus baseline mean)/mean at baseline]*100%.|Baseline, Week 16|Per Protocol Population||percent change||Standard Deviation|Mean
710673|NCT00159913|Secondary|Change From Baseline to Week 16 in World Health Organization (WHO) Pulmonary Hypertension (PH) Functional Class|WHO PH functional class definitions adapted from New York Heart Association Criteria for Functional Capacity and Therapeutic Class Definitions. Class I = PH without resulting limitation of physical activity, Class II = PH resulting in slight limitation of physical activity, Class III = PH resulting in marked limitation of physical activity, Class IV = PH with inability to carry out any physical activity without symptoms. Improved by 1 class = Class 4 to 3, Class 3 to 2, Class 2 to 1. Improved by 2 classes = Class 4 to 2, Class 3 to 1. Change is observed value at Week 16 minus Baseline value.|Baseline, Week 16|ITT population, LOCF||units|||Number
711400|NCT00178464|Primary|Number of Serious Adverse Events|Occurrence of individual serious adverse events and relationship to aspirin|12 months|Intention to treat||events|||Number
710674|NCT00159913|Secondary|Change From Baseline to Week 16 in Child Health Questionnaire Parent Form (CHQ-PF28), Psychosocial Scales|CHQ-PF28: validated generic Quality of Life (QoL) questionnaire for subjects >= 5 years. Includes 12 domain scores of QoL concepts including physical functioning, social & school activities, mental health, parent/family concepts. Scores range 0-100: lower scores = lower QoL. Change is observed value at Week 16 minus Baseline value.|Baseline, Week 16|ITT population, includes subjects >= 5years with a valid questionnaire available in the subject's first language.||score on scale||Standard Deviation|Mean
710675|NCT00159913|Secondary|Change From Baseline to Week 16 in Child Health Questionnaire Parent Form (CHQ-PF28), Physical Scale|CHQ-PF28: validated generic Quality of Life (QoL) questionnaire for subjects >= 5 years. Includes 12 domain scores of QoL concepts including physical functioning, social & school activities, mental health, parent/family concepts. Scores range 0-100: lower scores = lower QoL. Change is observed value at Week 16 minus Baseline value.|Baseline, Week 16|ITT population, includes subjects >= 5 years with a valid questionnaire available in the subject's first language.||score on scale||Standard Deviation|Mean
710676|NCT00159913|Secondary|Change From Baseline to Week 16 in Right Atrial Pressure (RAP)|RAP was measured using a pressure transducer positioned at the mid-axillary line with the patient in the supine position. Change is observed value at Week 16 minus Baseline value.|Baseline, Week 16|ITT population, using LOCF (end of treatment) approach for missing data.||mm Hg||Standard Deviation|Mean
710677|NCT00159913|Secondary|Change From Baseline to Week 16 in Cardiac Index (CI)|CI is observed value at Week 16 minus Baseline value. Calculated as cardiac output in systemic circulation (COsys) / body surface area (BSA).|Baseline, Week 16|ITT population, using LOCF (end of treatment) approach for handling missing data.||liters/minute/meters squared||Standard Deviation|Mean
710678|NCT00159913|Secondary|Change From Baseline to Week 16 in Pulmonary Vascular Resistance (PVR)|Change calculated as (mean PAP - PCWP)/COpulm in PVR is observed value at Week 16 minus Baseline value.|Baseline, Week 16|ITT population, using LOCF (end of treatment) approach for handling missing data||wood units||Standard Deviation|Mean
710679|NCT00159913|Secondary|Percent Change From Baseline to Week 16 in Time to Maximum Volume of Oxygen Consumed (VO2)|Time to maximum VO2 was assessed on the subset of subjects who are developmentally able to perform the exercise test. Percent change is [(value at Week 16 minus Baseline value)/Baseline value] * 100%|Baseline, Week 16|ITT population, LOCF (end-of-treatment) approach for handling missing values.||percent change||Standard Deviation|Mean
710680|NCT00159913|Secondary|Percent Change From Baseline to Week 16 in: Respiratory Exchange Ratio (RER)|RER is the ratio of carbon dioxide produced to oxygen consumed [VCO2/VO2]). Percent change is [(Week 16 value minus Baseline value)/Baseline value] * 100%|Baseline, Week 16|ITT population, LOCF (end-of-treatment) approach for handling missing values.||percent change||Standard Deviation|Mean
710681|NCT00159913|Secondary|Change From Baseline to Week 16 in Pulmonary Vascular Resistance Index (PVRI)|PVRI equals Pulmonary Vascular Resistance (PVR) times Body Surface Area (BSA). Wood unit = 80dyn•s/cm5. Change is observed value at Week 16 minus Baseline value.|Baseline, Week 16|ITT population, LOCF||wood units. m2||Standard Deviation|Mean
710682|NCT00159913|Secondary|Change From Baseline to Week 16 in Mean Pulmonary Artery Pressure (mPAP)|mPAP, a hemodynamic parameter, was measured using a pressure transducer positioned at the mid-axillary line with the patient in the supine position. Change is observed value at Week 16 minus Baseline value.|Baseline, Week 16|ITT population, using a LOCF (end-of-treatment) approach for handling missing data.||mm Hg||Standard Deviation|Mean
710683|NCT00159913|Primary|Percent Change From Baseline in Peak Volume of Oxygen (VO2) Consumed : Intent To Treat Population|Peak VO2 (normalized for body weight) at trough plasma levels assessed by CPX testing (bicycle ergometry)at the end of treatment (Week 16 for those who completed the study). Mean Percent change = [(week 16 value minus baseline mean)/mean at baseline]*100%.|Baseline, Week 16|ITT population included all subjects randomised and who received at least one dose of study medication. All subjects developmentally able to perform the exercise test. Subjects assumed developmentally able if they had a CPX exercise assessment at any visit during study using a LOCF (end-of-treatment)approach for handling missing data.||percent change||Standard Deviation|Mean
710684|NCT00159965|Secondary|Quality of Life in Epilepsy-31 (QOLIE-31)|This is a 31-item self-report scale used in the seizure population to evaluate Quality of Life. The lowest possible score is 0 and the highest possible score is 100, reflecting a better quality of life.|Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)|||Units on a scale||Standard Deviation|Mean
710685|NCT00159965|Secondary|Longitudinal Interval Follow-Up Evaluation Range of Impaired Functioning Tool (LIFE-RIFT)|"The LIFE-RIFT interview is a brief semi-structured interview, which measures functional impairment, targeting four domains: work, interpersonal relations, recreation and global satisfaction. Work, recreation and global satisfaction are rated on a 1 (very good/ no impairment) to 5 (very poor/ severe impairment) scale, and interpersonal relations is rated on a 1 (very good) to 7 (variable) scale. The highest score possible is 20 and relates to a more severe impairment. The lowest possible score is 3."|Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)|||Units on a scale||Standard Deviation|Mean
710686|NCT00159965|Secondary|Family Assessment Device (FAD)|"The FAD is a 60 item self-report questionnaire designed to assess the six dimensions of the McMaster Model of Family Functioning, as well as overall level of family functioning through the General Functioning Scale. Each question is scored on a 1 to 4 scale, with a higher mean score relating to a worse general functioning."|Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)|||General Functioning Subscale Score||Standard Deviation|Mean
710687|NCT00159965|Secondary|Clinical Global Impressions - Improvement (CGI-I)|"The CGI-I is the second item of a two item global rating scale, where each item is on a 7 point scale ranging from very much improved (1) to very much worse (7). A lower score represents a higher improvement."|Weeks 2, 6, 10|||Units on a scale||Standard Deviation|Mean
710688|NCT00159965|Secondary|Clinical Global Impressions - Severity (CGI-S)|"The CGI-S is the first item of a two-item global rating scale, where each item is on a 7 point scale ranging from normal (1) to among the most extremely ill patients (7). A higher score relates to a higher severity of illness."|Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)|||Units on a scale||Standard Deviation|Mean
710689|NCT00159965|Secondary|Oxford Handicap Scale (OHS)|"The OHS is a brief clinician scored assessment of symptoms and lifestyle interference and the 6 grades of disability are based on the modified Rankin Scale, ranging from 0 (no symptoms) to 5 (severe handicap). A higher score relates to a worse outcome."|Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)|||Units on a scale||Standard Deviation|Mean
710691|NCT00159965|Secondary|Dissociative Experiences Scale (DES)|The DES is a 28 item self-report questionnaire designed to quantify dissociative experiences which identifies disturbances in memory, identity, cognition, derealization, depersonalization, absorption and imagination. A visual analogue scale is used ranging from 0% (“This never happens to you”) to 100% (“This always happens to you”). The score is divided by 28 items to yield a range of 0 to 100%, with a higher score relating to a higher degree of dissociation.|Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)|||units on a scale||Standard Deviation|Mean
710692|NCT00159965|Secondary|Barratt Impulsivity Scale (BIS)|"The BIS is a 30 item self-report measure that characterizes four aspects of impulsiveness, and ranges from rarely/ never to almost always with a score of 1 to 4 possible on each question, giving a maximum possible score of 120 and minimum possible score of 30. Selected questions are reversed scored. Higher scores relate to a worse outcome."|Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)|||Units on a scale||Standard Deviation|Mean
710693|NCT00159965|Secondary|Davidson Trauma Scale (DTS)|The DTS is a 17-item self-report scale measuring each Diagnostic and Stastical Manual of Mental Disorders-4th Edition (DSM-IV) symptom of post-traumatic stress disorder (PTSD) on 5-point frequency (0-not at all to 4-everyday) and severity (0-not at all distressing to 4-extremely distressing) scales. The highest possible score is 136 and relates to the worst outcome.|Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)|||units on a scale||Standard Deviation|Mean
710694|NCT00159965|Secondary|Global Assessment of Functioning (GAF)|This GAF rating scale ranges from 0 (worst) to 100 (best) and is used for evaluating the overall functioning of a subject during a specified time period on a continuum from psychological or psychiatric sickness to health.|Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)|||Units on a scale||Standard Deviation|Mean
710695|NCT00159965|Secondary|Modified Hamilton Depression Scale (MHRS)|"The MHRS assesses the severity of Depression-related symptoms from 0 (not present) to 2, 3 or 4 (severe) on each question. The highest possible score is 72, relating to the worst outcome."|Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)|||units on a scale||Standard Deviation|Mean
710696|NCT00159965|Secondary|Beck Depression Inventory-II (BDI-II)|"The BDI-II assesses depression severity from 0 (no Depression-related symptom) to 3 (severe) on each question. The highest possible score is 51, relating to the worst outcome."|bi-weekly at baseline and weeks 2, 4, 6, 8, 10, 12|||Units on a scale||Standard Deviation|Mean
710697|NCT00159965|Primary|Number of Nonepileptic Seizures (NES)|psychogenic nonepileptic seizure (NES) frequency, collected prospectively, using a daily seizure calendar; aggregated into biweekly intervals.|bi-weekly at baseline and weeks 2, 4, 6, 8, 10, 12|||seizures||Standard Deviation|Median
710698|NCT00160199|Secondary|Time to Withdrawal Bleeding After Second Treatment Cycle|The number of days between the second cycle of treatment and the withdrawal bleeding|End of the second cycle of treatment (cycle=28 days)|The analysis was done on the Full Analysis Sample defined as subjects who received at least one dose of treatment and with at least one post-baseline evaluable efficacy assessment. Only summary statistics were generated.||Days||Standard Deviation|Mean
710699|NCT00160199|Secondary|Time to Withdrawal Bleeding After First Treatment Cycle|The number of days between the first cycle of treatment and the withdrawal bleeding.|End of the first cycle of treatment (cycle=28 days)|The analysis was done on the Full Analysis Sample defined as subjects who received at least one dose of treatment and with at least one post-baseline evaluable efficacy assessment. Only summary statistics were generated.||Days||Standard Deviation|Mean
710700|NCT00160199|Secondary|The Duration of Withdrawal Bleeding After Second Treatment Cycle|The numbers of days the subjects actually bled after the end of the second treatment cycle|End of the second cycle of treatment (cycle=28 days)|The analysis was done on the Full Analysis Sample defined as subjects who received at least one dose of treatment and with at least one post-baseline evaluable efficacy assessment. Only summary statistics were generated.||Days||Standard Deviation|Mean
710701|NCT00160199|Secondary|The Duration of Withdrawal Bleeding After the First Treatment Cycle|The numbers of days the subjects actually bled after the end of the first treatment cycle.|End of the first cycle of treatment (cycle=28 days)|The analysis was done on the Full Analysis Sample defined as subjects who received at least one dose of treatment and with at least one post-baseline evaluable efficacy assessment. Only summary statistics were generated.||Days||Standard Deviation|Mean
710702|NCT00160199|Secondary|Maximum Intensity of Withdrawal Bleeding After Any Cycle|The intensity of withdrawal bleeding was classified by: None, Spotting, Light, Moderate, Heavy|Duration of withdrawal bleed|The analysis was done on the Full Analysis Sample defined as subjects who received at least one dose of treatment and with at least one post-baseline evaluable efficacy assessment. Only summary statistics were generated.||participants|||Number
710703|NCT00160199|Primary|Number of Subjects With Withdrawal Bleeding|This measure is the number of subjects with withdrawal bleeding using Last Observation Carried Forward (LOCF) after first and second cycle.|After first and second cycle (cycle=28 days)|The analysis was done on the Full Analysis Sample defined as subjects who received at least one dose of treatment and with at least one post-baseline evaluable efficacy assessment. Only summary statistics were generated.||participants|||Number
710704|NCT00160199|Primary|Secretory Conversion of the Endometrium|Endometrial biopsy results were classified as : Secretory (Complete or partial), Non-secretory, Unable to determine or Unknown after an evaluation of morphologic criteria.|End of the study (Days 85)|The analysis was done on the Full Analysis Sample defined as subjects who received at least one dose of treatment and with at least one post-baseline evaluable efficacy assessment. Only summary statistics were generated.||participants|||Number
710705|NCT00160251|Primary|Percent of Participants Who Achieved Sustained Virologic Response (SVR)|"SVR was defined as the percentage of participants with Hepatitis C Virus Ribonucleic Acid (HCV-RNA) undetectable at the follow-up Week 24.
All percentages were based on the total number of participants originally randomized/enrolled to that particular arm.
For Arm 1B, the denominator for the percentages was the number who received at least 1 dose of BOC.
Arm 1A was not analyzed."|Baseline up to Week 73 [24 weeks after end of treatment (EoT)]|For PEG + RBV + BOC number of participants was number who received at least one dose of BOC. For all others, it was number of randomized participants. The PEG + BOC 800 arm was not randomized.||Percent of participants|||Number
710821|NCT00168454|Primary|Change in Number of Urinary Urge Incontinence Episodes|Mean number of urinary urge incontinence episodes measured over a 7-day diary prior to week 12. Urinary urge incontinence is defined as urinary leakage associated with a strong desire to urinate.|Baseline, Week 2, Week 6, Week 12|Intent to Treat||episodes|||Number
710706|NCT00160251|Secondary|Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)|Log drop at baseline of dosing change = difference of log viral loads between baseline (closest to the treatment begin date) and dosing change baseline (virology value closest to the dosing change begin date).|From dosing change to end of follow-up (Week 73) (up to 48 weeks)|All participants, per the second amendment to P03659, with significant HCV-RNA decrease (HCV_RNA ≤ 10,000 IU) switched to continuing triple therapy.||Participants|||Number
710707|NCT00160251|Secondary|Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)|Log drop at baseline of dosing change = difference of log viral loads between baseline (closest to the treatment begin date) and dosing change baseline (virology value closest to the dosing change begin date).|From dosing change to end of follow-up (Week 73)(up to 48 weeks)|All participants, per the second amendment to P03659, with significant HCV-RNA decrease (HCV_RNA ≤ 10,000 IU) switched to continuing triple therapy.||Participants|||Number
710708|NCT00160251|Secondary|Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])|Log drop at baseline of dosing change = difference of log viral loads between baseline (closest to the treatment begin date) and dosing change baseline (virology value closest to the dosing change begin date).|From dosing change to end of follow-up (Week 73)(up to 48 weeks)|All participants, per the second amendment to P03659, with significant HCV-RNA decrease (HCV_RNA ≤ 10,000 IU) switched to continuing triple therapy.||Participants|||Number
710709|NCT00160251|Secondary|Change in Alanine Aminotransferase (ALT) Levels|Change in ALT levels during initial treatment regimen and after rolling into amendment 2 as compared to baseline.|Baseline up to dosing change (> 25 weeks)|Only participants with at least one value for the laboratory test were included.||Participants|||Number
710710|NCT00160251|Secondary|Trough Plasma Concentration Level|All plasma samples were assayed using a validated liquid chromatography with tandem mass spectrometric detection (LCMS/MS) method.|All visits during treatment (baseline to Week 49) except Day 1 of Week 1|Participants were only included in the analysis if the recorded previous dose of boceprevir was taken < 8.5 hours prior to sample collection. Participants also must have started BOC treatment or amendment 2 dosing more than 1 week prior to sample collection.||ng/mL||Standard Error|Mean
710711|NCT00160251|Secondary|Area Under the Plasma Concentration-time Curve of Boceprevir Plasma Concentration for an 8-hour Dosing Period|"All plasma samples were assayed using a validated liquid chromatography with tandem mass spectrometric detection (LCMS/MS) method.
The dosing interval of 8 hours is represented as the hr in the unit of measure."|All visits during treatment (baseline to Week 49) except Day 1 of Week 1|Participants were only included in the analysis if the recorded previous dose of boceprevir was taken < 8.5 hours prior to sample collection. Participants also must have started BOC treatment or amendment 2 dosing more than 1 week prior to sample collection.||ng*hr/mL||Standard Error|Mean
710712|NCT00160251|Secondary|Peak Plasma Concentration of Boceprevir (BOC)|All plasma samples were assayed using a validated liquid chromatography with tandem mass spectrometric detection (LCMS/MS) method.|All visits during treatment (baseline to Week 49) except Day 1 of Week 1|Participants were only included in the analysis if the recorded previous dose of boceprevir was taken < 8.5 hours prior to sample collection. Participants also must have started BOC treatment or amendment 2 dosing more than 1 week prior to sample collection.||ng/mL||Standard Error|Mean
710713|NCT00160251|Secondary|Percent of Participants With Virologic Response Prior to Amendment 2|Virologic response was defined as the percentage of participants with Hepatitis C Virus Ribonucleic Acid (HCV-RNA) ≤10,000 IU/mL.|Week 3, Week 5, Week 13|||Percent of participants|||Number
710714|NCT00160251|Secondary|Percentage of Participants Who Were HCV-RNA Negative at EoT After Receiving 1 Week of Treatment With PegIntron (PEG) by Log Drop|"For each log drop category (<0, 0 to 0.5, 0.5 to <1, 1 to <1.5, ≥1.5, and Missing), the percentage of participants receiving combination therapy who were HCV-RNA negative at EoT (Week 49) was calculated as follows:
Number of participants in a log category who were HCV-RNA negative divided by the total number of participants in that log drop category (n).
Percentages were NOT derived using treatment arm N values. The sum of the n values for all 6 log drop categories within a treatment arm equals the overall N for that treatment group."|Week 1 and Week 49|N=Number of Participants Analyzed, n=number of participants in each log category group. The PEG + BOC 100, 200, or 400 arm combined the following treatment arms: Arm 2 PEG + BOC 100 (48 weeks), Arm 3 PEG + BOC 200 (48 weeks), Arm 4 PEG + BOC 400 (48 weeks), Arm 6 PEG + BOC 400 (24 weeks).||Percent of participants|||Number
710715|NCT00160251|Secondary|Percent of Participants Who Achieved Sustained Viral Response (SVR) by Time to First Negative HCV-RNA|Percentage of participants who became HCV-RNA undetectable within the first 13 weeks and subsequently became HCV-RNA positive were not considered negative for this analysis.|Baseline up to Week 73 [24 weeks after EoT]|Number of participants across all treatment arms who achieved negative HCV-RNA||Percent of participants|||Number
710716|NCT00160251|Primary|Percent of Participants Who Were Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Negative at the End of Treatment (EoT)|"Sustained Viral Response (SVR) was defined as the percentage of participants with HCV-RNA undetectable at the follow-up Week 24.
All percentages were based on the total number of participants originally randomized/enrolled to that particular arm.
For Arm 1B, the denominator for the percentages was the number who received at least 1 dose of BOC.
Arm 1A was not analyzed."|Baseline up to Week 49|For PEG + RBV + BOC number of participants was number who received at least one dose of BOC. For all others, it was number of randomized participants. The PEG + BOC 800 arm was not randomized.||Percent of participants|||Number
710717|NCT00166036|Secondary|Change in Flow-mediated Dilatation (FMD)|Flow-mediated dilatation (FMD) of the brachial artery was used to asses Endothelial Function. The endothelium, by releasing nitric oxide (NO), promotes vasodilation and inhibits inflammation, thrombosis, and vascular smooth muscle cell proliferation.We hypothesized that equipotent doses of these two statins will have divergent effects on markers of oxidative stress and endothelial function.|Baseline & 12 Weeks|||Percentage of brachial artery diameter||Standard Error|Mean
710750|NCT00167778|Secondary|Average Residual Limb Pain?|The residual limb pain grade scores ranged from 0 “No Pain/ Interference” to 10 “Severe Pain/Interference.”|Measurements were taken after wearing the study prostheses for four weeks.|10 participants wore both study prostheses but only 7 participants presented with pain.||units on a scale||Standard Error|Mean
710718|NCT00166036|Primary|Change in Plasma Thiobarbituric Acid Reactive Substance (TBARS) Levels|Oxidative stress was assessed with plasma thiobarbituric acid reactive substance (TBARS) levels (an index of lipid peroxidation).Oxidative stress reflects an imbalance between the systemic manifestation of reactive oxygen species and a biological system's ability to readily detoxify the reactive intermediates or to repair the resulting damage.We hypothesized that equipotent doses of these two statins will have divergent effects on markers of oxidative stress and endothelial function.|Baseline &12 Weeks|||nmol/mL||Standard Error|Mean
710719|NCT00166114|Primary|Response of Participants, Defined by Change in the 21-item Hamilton Depression Rating Scale (HDRS) From Baseline to Week8|"Number of subjects that showed no response, partial response, and response based on scores from baseline and week 8.
The 21-item HDRS measures depression severity. The scoring is sum the total of all 21 items to arrive at the total score, with a range of 0 to 60, where higher scores indicated greater severity. Nine items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Eleven items are scored from 0 - 2 (0 = absent and 2 = severe). The last item is scored on a 4-point scale of 0-3 (0 = absent and 3 = severe). The HDRS at week 8 was compared to the baseline HDRS and each participant's response was calculated using the below table:
No Response = < 25% change in Depression Rating Scale Score Partial Responder = < 50% to >25% change in Depression Rating Scale Score Responder = 50% or greater change in Depression Rating Scale Score"|Baseline, Week 8|||participants|||Number
710720|NCT00166166|Secondary|Change in Tissue Plasminogen Activator (t-PA) Release After Fluconazole, Tetraethylammonium (TEA), and Bradykinin Administration|Individual net t-PA release at each time point were calculated by the following formula: net release = (Cv-CA) x {FBF x [101-hematocrit/100]}, where Cv and CA represent the concentration of t-PA in the brachial vein and artery, respectively. Change is the difference of t-PA after fluconazole and tetraethylammonium (TEA) and t-PA after bradykinin 400 ng/min|60 minutes, 90 minutes|Only 10 of the original 174 subjects were treated for this portion of the study.||ng/mL||Standard Error|Mean
710721|NCT00166166|Secondary|Change in Tissue Plasminogen Activator (t-PA) Release After Fluconazole and Bradykinin Administration|Individual net t-PA release at each time point were calculated by the following formula: net release = (Cv-CA) x {FBF x [101-hematocrit/100]}, where Cv and CA represent the concentration of t-PA in the brachial vein and artery, respectively. Change is the difference of t-PA after fluconazole and t-PA after bradykinin 400 ng/min|30 minutes, 60 minutes|Only 11 of the original 174 subjects were treated for this portion of the study.||ng/mL||Standard Error|Mean
710722|NCT00166166|Secondary|Change in Tissue Plasminogen Activator (t-PA) Release After Tetraethylammonium (TEA) and Bradykinin Administration|Individual net t-PA release at each time point were calculated by the following formula: net release = (Cv-CA) x {FBF x [101-hematocrit/100]}, where Cv and CA represent the concentration of t-PA in the brachial vein and artery, respectively. Change is the difference of t-PA after Tetraethylammonium (TEA) and t-PA after bradykinin 400 ng/min|30 minutes, 60 minutes|Only 18 of the original 174 subjects were treated for this portion of the study.||ng/mL||Standard Error|Mean
710723|NCT00166166|Secondary|Change in Tissue Plasminogen Activator (t-PA) Release|Individual net t-PA release at each time point were calculated by the following formula: net release = (Cv-CA) x {FBF x [101-hematocrit/100]}, where Cv and CA represent the concentration of t-PA in the brachial vein and artery, respectively. Change is the difference of t-PA at baseline and t-PA after bradykinin 400 ng/min|Baseline, 30 minutes|Only 33 of the original 174 subjects were treated for this portion of the study.||ng/mL||Standard Error|Mean
710724|NCT00166166|Secondary|Forearm Blood Flow (FBF) After Sodium Nitroprusside Administration|Simultaneous forearm blood flow (FBF) measurements were obtained in both arms using a dual-channel venous occlusion strain gauge plethysmograph after administration of sodium nitroprusside. Flow measurements were recorded for approximately 7 seconds, every 15 seconds up to eight times and a mean FBF value was computed.|5 minutes|Only 80 of the original 174 subjects were treated for this portion of the study.||mL min^-1 * 100 mL^-1||Standard Error|Mean
710725|NCT00166166|Secondary|Percent Change in Forearm Blood Flow (FBF) After Fluconazole and Tetraethylammonium (TEA) Administration|Simultaneous forearm blood flow (FBF) measurements were obtained in both arms using a dual-channel venous occlusion strain gauge plethysmograph after administration of fluconazole and Tetraethylammonium (TEA) administration. Flow measurements were recorded for approximately 7 seconds, every 15 seconds up to eight times and a mean FBF value was computed. Percent change is the difference from FBF after fluconazole administration and after Tetraethylammonium (TEA) administration.|5 minutes, 10 minutes|Only 19 of the original 174 subjects were treated for this portion of the study.||percent change||Standard Error|Mean
710726|NCT00166166|Secondary|Percent Change in Forearm Blood Flow (FBF) After L-NG-monomethyl Arginine (L-NMMA) and Fluconazole Administration|Simultaneous forearm blood flow (FBF) measurements were obtained in both arms using a dual-channel venous occlusion strain gauge plethysmograph after L-NMMA administration and administration of fluconazole. Flow measurements were recorded for approximately 7 seconds, every 15 seconds up to eight times and a mean FBF value was computed. Percent change is the difference in FBF after L-NMMA administration and then fluconazole administration.|5 minutes, 10 minutes|Only 15 of the original 174 subjects were treated for this portion of the study.||percent change||Standard Error|Mean
710727|NCT00166166|Secondary|Percent Change in Forearm Blood Flow (FBF) After Fluconazole Administration|Simultaneous forearm blood flow (FBF) measurements were obtained in both arms using a dual-channel venous occlusion strain gauge plethysmograph at rest and after administration of fluconazole. Flow measurements were recorded for approximately 7 seconds, every 15 seconds up to eight times and a mean FBF value was computed. Percent change is the difference from baseline FBF and after fluconazole administration.|Baseline, 5 minutes|Only 33 of the original 174 subjects were treated for this portion of the study.||percent change||Standard Error|Mean
710728|NCT00166166|Secondary|Percent Change in Forearm Blood Flow (FBF) After Administration of L-NG-monomethyl Arginine (L-NMMA) and Tetraethylammonium (TEA)|Simultaneous forearm blood flow (FBF) measurements were obtained in both arms using a dual-channel venous occlusion strain gauge plethysmograph after administration of L-NG-monomethyl Arginine (L-NMMA) and Tetraethylammonium (TEA). Flow measurements were recorded for approximately 7 seconds, every 15 seconds up to eight times and a mean FBF value was computed. Percent change is the difference in FBF from after L-NMMA administration and after TEA administration.|5 minutes, 10 minutes|Only 62 of the original 174 subjects were treated for this portion of the study.||percent change||Standard Error|Mean
710822|NCT00168805|Secondary|Laboratory Analyses|Frequency of patients with possible clinically significant abnormalities.|First administration to end of study|Treated patients||participants|||Number
710729|NCT00166166|Primary|Percent Change in Forearm Blood Flow (FBF) After Administration of L-NG-monomethyl Arginine (L-NMMA)|Simultaneous forearm blood flow (FBF) measurements were obtained in both arms using a dual-channel venous occlusion strain gauge plethysmograph after administration of L-NG-monomethyl Arginine (L-NMMA). Flow measurements were recorded for approximately 7 seconds, every 15 seconds up to eight times and a mean FBF value was computed. Percent change is the difference in FBF from baseline and after L-NMMA administration.|Baseline, 5 minutes|Only 62 of the original 174 subjects were treated for this portion of the study.||percent change||Standard Error|Mean
710730|NCT00166166|Primary|Percent Change in Forearm Blood Flow (FBF) After Tetraethylammonium (TEA) Administration|Simultaneous forearm blood flow (FBF) measurements were obtained in both arms using a dual-channel venous occlusion strain gauge plethysmograph at rest and after administration of tetraethylammonium (TEA). Flow measurements were recorded for approximately 7 seconds, every 15 seconds up to eight times and a mean FBF value was computed. Percent change is the difference from baseline FBF and after TEA administration.|Baseline, 5 minutes|Only 62 of the original 174 subjects were treated for this portion of the study.||percent change||Standard Error|Mean
710731|NCT00166205|Secondary|Changes in Total Cholesterol|Changes in Total Cholesterol, at three-years post-operative minus baseline.|3 years|||Mg/dl||Standard Deviation|Mean
710732|NCT00166205|Secondary|Changes in Low Density Lipoproteins (LDL)|Changes in Low Density Lipoproteins (LDL), at three-years post-operative minus baseline.|3 years|||Mg/dl||Standard Deviation|Mean
710733|NCT00166205|Secondary|Changes in High Density Lipoproteins (HDL)|Changes in High Density Lipoproteins (HDL), at three-years post-operative minus baseline.|3 year|||Mg/dl||Standard Deviation|Mean
710734|NCT00166205|Primary|Percent Excess Weight Loss|Percent Excess Weight Loss (%EWL) with the SAGB at three years post operatively minus baseline.|3 Years Post Operative|Intent to Treat (ITT), Last Observation Carried Forward (LOCF)||Percent Excess Weight Loss||95% Confidence Interval|Mean
710735|NCT00166205|Secondary|Number of All Adverse Events of Subjects Implanted With the SAGB|The evaluation of all Adverse Events of subjects implanted with the Swedish Adjustable Gastric Band throughout the three-year post-operative period (related to device and unrelated to device).|3 Years|||Total Number of Adverse Events|||Number
710736|NCT00166205|Secondary|Changes in Glycosylated Hemoglobin (HbA1c)|Changes in glycosylated hemoglobin (HbA1c), from baseline to three-years post-operative.|3 years|||Percent of total hemogloobin||Standard Deviation|Mean
710737|NCT00166205|Secondary|Changes in Quality of Life (QOL) Measures|Changes in QOL measures at three-years post-operative minus baseline. SF-36 scores from 0-100 with higher scores representing better QOL.|3 years|||Units on a scale||Standard Deviation|Mean
710738|NCT00166205|Secondary|Change in Absolute Weight|Absolute weight loss as measured on a standardized Tanita Scale (used at all sites) at three-years post-operative minus baseline.|3 years|||Pounds||Standard Deviation|Mean
710739|NCT00166205|Secondary|Changes in Body Mass Index (BMI)|Changes in Body Mass Index (BMI) at three-years post-operative minus baseline.|3 years|||kg/m2||Standard Deviation|Mean
710740|NCT00166205|Secondary|Changes in Excess Body Weight (EBW)|Changes in excess body weight at 3-years post-operative minus baseline excess weight. Excess weight is computed as baseline weight minus Ideal weight. Ideal weight as provided in the 1983 Metropolitan Life Height and Weight Table using the upper limit of the midpoint range.|3 years|||Pounds||Standard Deviation|Mean
710741|NCT00166205|Primary|Percent of Subjects Who Had Adverse Events With the Swedish Adjustable Gastric Band (SAGB)|Percent of device-related adverse events (AEs) and device malfunctions occurring in subjects implanted with the Swedish Adjustable Gastric Band from baseline throughout the three-year post-operative period.|3 years|Intent to Treat (ITT)||Percent of Subjects|||Number
710742|NCT00166296|Secondary|Total Score in the Depression Subscale of the Hospital Anxiety and Depression Scale.|"The Hospital Anxiety and Depression Scale (HADS) is 14-item scale, patient-administered, that allows two independent scores of depression and anxiety. It has been specially designed to apply in patients with comorbid medical conditions as it excludes somatic or vegetative symptoms from the depression subscale.
We present data of de depression subscale. The seven-item Depression subscale yields a score of 0–21, with higher scores meaning higher levels of depressive symptoms."|12 weeks after interferon treatment onset|||Scores on a Scale||Standard Error|Mean
710743|NCT00166296|Secondary|Total Score in the Montgomery-Asberg Depression Rating Scale|"The MADRS is a 10-item scale, clinician-administered, which is sensitive to symptom change during antidepressant treatment. It has been frequently used to measure depressive symptoms during interferon-alpha therapy and exhibits improved internal consistency in patients with co-morbid medical conditions compared with other clinician-administered questionnaires.
Items are rated on a scale of 0–6. Scores range from 0 to 60, higher scores meaning higher levels of depression."|12 weeks after interferon treatment onset|||Scores on a scale||Standard Error|Mean
710744|NCT00166296|Primary|Number of Participants With Sustained Hepatitis C Viral Response (Negativization of Serum Hepatitis C Virus Ribonucleic Acid).|"Number of participants with negativization of serum hepatitis C Virus Ribonucleic Acid (HCV RNA) 6 months after concluding antiviral therapy (sustained viral response).
Negativization was defined as the absence of detectable levels of serum HCV RNA using a polymerase chain reaction."|Six months after the end of interferon treatment|Patients with available data for viral response 6 months after completion of interferon treatment were compared between treatment groups.||Participants|||Number
710745|NCT00166296|Primary|Number of Participants Who Developed a Major Depressive Episode According to Diagnostic & Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) Criteria During the First 12 Weeks of Antiviral Treatment.|"At least five of the symptoms have been present during the same 1-week period: depressed mood, loss of interest or pleasure, weight or appetite changes, insomnia, agitation or retardation, fatigue, feelings of worthlessness or guilt, diminished ability to think or concentrate, recurrent thoughts of death.
At least one of the symptoms is either depressed mood or loss of interest. Diagnoses were made by a trained psychiatrist who applied the mood disorders module from the Structured Clinical Interview for DSM-IV Axis I Disorders, non-patient edition (SCID-I/NP) at each study evaluation."|First three months of interferon treatment.|One of 67 patients allocated to the escitalopram group and 3 of 66 in placebo did not receive the first dose of study medications. Consequently, 66 patients treated with escitalopram and 63 with placebo were included in the intention to treat analysis, with a procedure of last observation carried forward (LOCF).||Participants|||Number
710823|NCT00168805|Secondary|Volume of Blood Loss|Volume of blood loss for treated and operated patients during surgery.|Day 1|||mL||Standard Deviation|Mean
710751|NCT00167778|Secondary|Residual Limb Pain at Present?|The residual limb pain grade scores ranged from 0 “No Pain/ Interference” to 10 “Severe Pain/Interference.”|Measurements were taken after wearing the study prostheses for four weeks|10 participants wore both study prostheses but only 7 participants presented with pain.||units on a scale||Standard Error|Mean
710752|NCT00167778|Secondary|Six-minute Walk Distance|Participants are asked to walk alone as far as possible without running for six minutes. This test is performed indoors along a long, flat straight hallway of approximately 30 meters in length with two orange cones marking the 180 degree turnaround points at each end of the corridor. Approximately 40 straight steps were taken for every four turning steps.|Six minutes after wearing the study prostheses for four weeks.|Each participant wore both study prostheses.||m||Standard Error|Mean
710753|NCT00167778|Secondary|Activity Level|Average number of steps per day over a 1 week period ending in the fourth week of each study prosthesis (Rigid and Torsion adapter)|One week|Each participant wore both study prostheses.||Steps/day||Standard Error|Mean
710754|NCT00167778|Secondary|Peak External Rotation Moment of the Inside Ankle While Turning||Measurements were taken after wearing the study prostheses for three weeks.|Each participant wore both study prostheses.||N*mm/kg||Standard Deviation|Mean
710755|NCT00167778|Secondary|Peak External Rotation Moment of the Inside Knee While Turning||Measurements were taken after wearing the study prostheses for three weeks.|Each participant wore both study prostheses.||N*mm/kg||Standard Deviation|Mean
710756|NCT00167778|Secondary|Peak External Rotation Moment of the Inside Hip While Turning||Measurements were taken after wearing the study prostheses for three weeks.|Each participant wore both study prostheses.||N*mm/kg||Standard Deviation|Mean
710757|NCT00167778|Secondary|Peak External Rotation Moment of the Outside Ankle While Turning||Measurements were taken after wearing the study prostheses for three weeks.|Each participant wore both study prostheses.||N*mm/kg||Standard Deviation|Mean
710758|NCT00167778|Secondary|Peak External Rotation Moment of the Outside Knee While Turning||Measurements were taken after wearing the study prostheses for three weeks.|Each participant wore both study prostheses.||N*mm/kg||Standard Deviation|Mean
710759|NCT00167778|Secondary|Peak External Rotation Moment of the Outside Hip While Turning||Measurements were taken after wearing the study prostheses for three weeks.|Each participant wore both study prostheses.||N*mm/kg||Standard Deviation|Mean
710760|NCT00167778|Primary|Local Dynamic Stability (Ankle During Turning With the Prosthesis on the Outside of the Turn)|Maximum finite-time Lyapunov exponents were used to estimate the local dynamic stability of the amputee’s sagittal plane hip, knee and ankle angles for their prosthetic limb with and without the torsion adapter while walking straight, while turning with the prosthesis on the inside of the turn, and while turning with the prosthesis on the outside of the turn. Maximum finite-time Lyapunov exponents measure the rate of kinematic separation of a gait cycle trajectory perturbed by naturally occurring disturbances and neuromuscular control errors. A positive exponent indicates divergence of a system, with increasing values indicating a les stable system.|Measurements were taken after wearing the study prostheses for three weeks.|Each participant wore both study prostheses.||dimensionless||Standard Deviation|Mean
710761|NCT00167778|Primary|Local Dynamic Stability (Knee During Turning With the Prosthesis on the Outside of the Turn)|Maximum finite-time Lyapunov exponents were used to estimate the local dynamic stability of the amputee’s sagittal plane hip, knee and ankle angles for their prosthetic limb with and without the torsion adapter while walking straight, while turning with the prosthesis on the inside of the turn, and while turning with the prosthesis on the outside of the turn. Maximum finite-time Lyapunov exponents measure the rate of kinematic separation of a gait cycle trajectory perturbed by naturally occurring disturbances and neuromuscular control errors. A positive exponent indicates divergence of a system, with increasing values indicating a les stable system.|Measurements were taken after wearing the study prostheses for three weeks.|Each participant wore both study prostheses.||dimensionless||Standard Deviation|Mean
710762|NCT00167778|Primary|Local Dynamic Stability (Hip During Turning With the Prosthesis on the Outside of the Turn)|Maximum finite-time Lyapunov exponents were used to estimate the local dynamic stability of the amputee’s sagittal plane hip, knee and ankle angles for their prosthetic limb with and without the torsion adapter while walking straight, while turning with the prosthesis on the inside of the turn, and while turning with the prosthesis on the outside of the turn. Maximum finite-time Lyapunov exponents measure the rate of kinematic separation of a gait cycle trajectory perturbed by naturally occurring disturbances and neuromuscular control errors. A positive exponent indicates divergence of a system, with increasing values indicating a les stable system.|Measurements were taken after wearing the study prostheses for three weeks.|Each participant wore both study prostheses.||dimensionless||Standard Deviation|Mean
710763|NCT00167778|Primary|Local Dynamic Stability (Ankle During Turning With the Prosthesis on the Inside of the Turn)|Maximum finite-time Lyapunov exponents were used to estimate the local dynamic stability of the amputee’s sagittal plane hip, knee and ankle angles for their prosthetic limb with and without the torsion adapter while walking straight, while turning with the prosthesis on the inside of the turn, and while turning with the prosthesis on the outside of the turn. Maximum finite-time Lyapunov exponents measure the rate of kinematic separation of a gait cycle trajectory perturbed by naturally occurring disturbances and neuromuscular control errors. A positive exponent indicates divergence of a system, with increasing values indicating a les stable system.|Measurements were taken after wearing the study prostheses for three weeks.|Each participant wore both study prostheses.||dimensionless||Standard Deviation|Mean
710764|NCT00167778|Primary|Local Dynamic Stability (Knee During Turning With the Prosthesis on the Inside of the Turn)|Maximum finite-time Lyapunov exponents were used to estimate the local dynamic stability of the amputee’s sagittal plane hip, knee and ankle angles for their prosthetic limb with and without the torsion adapter while walking straight, while turning with the prosthesis on the inside of the turn, and while turning with the prosthesis on the outside of the turn. Maximum finite-time Lyapunov exponents measure the rate of kinematic separation of a gait cycle trajectory perturbed by naturally occurring disturbances and neuromuscular control errors. A positive exponent indicates divergence of a system, with increasing values indicating a les stable system.|Measurements were taken after wearing the study prostheses for three weeks.|Each participant wore both study prostheses.||dimensionless||Standard Deviation|Mean
710819|NCT00168454|Secondary|Change in Number of Nocturia Episodes|Mean number of nocturia episodes measured over a 7 day diary prior to each visit. A nocturia episode is a void (urinating into the toilet) that interrupts one's sleep.|Baseline, Week 12|Intent to Treat||episodes|||Number
710765|NCT00167778|Primary|Local Dynamic Stability (Hip During Turning With the Prosthesis on the Inside of the Turn)|Maximum finite-time Lyapunov exponents were used to estimate the local dynamic stability of the amputee’s sagittal plane hip, knee and ankle angles for their prosthetic limb with and without the torsion adapter while walking straight, while turning with the prosthesis on the inside of the turn, and while turning with the prosthesis on the outside of the turn. Maximum finite-time Lyapunov exponents measure the rate of kinematic separation of a gait cycle trajectory perturbed by naturally occurring disturbances and neuromuscular control errors. A positive exponent indicates divergence of a system, with increasing values indicating a les stable system.|Measurements were taken after wearing the study prostheses for three weeks.|Each participant wore both study prostheses.||dimensionless||Standard Deviation|Mean
710766|NCT00167778|Primary|Local Dynamic Stability (Ankle During Straight Walking)|Maximum finite-time Lyapunov exponents were used to estimate the local dynamic stability of the amputee’s sagittal plane hip, knee and ankle angles for their prosthetic limb with and without the torsion adapter while walking straight, while turning with the prosthesis on the inside of the turn, and while turning with the prosthesis on the outside of the turn. Maximum finite-time Lyapunov exponents measure the rate of kinematic separation of a gait cycle trajectory perturbed by naturally occurring disturbances and neuromuscular control errors. A positive exponent indicates divergence of a system, with increasing values indicating a les stable system.|Measurements were taken after wearing the study prostheses for three weeks.|Each participant wore both study prostheses.||dimensionless||Standard Deviation|Mean
710767|NCT00167778|Primary|Local Dynamic Stability (Knee During Straight Walking)|Maximum finite-time Lyapunov exponents were used to estimate the local dynamic stability of the amputee’s sagittal plane hip, knee and ankle angles for their prosthetic limb with and without the torsion adapter while walking straight, while turning with the prosthesis on the inside of the turn, and while turning with the prosthesis on the outside of the turn. Maximum finite-time Lyapunov exponents measure the rate of kinematic separation of a gait cycle trajectory perturbed by naturally occurring disturbances and neuromuscular control errors. A positive exponent indicates divergence of a system, with increasing values indicating a les stable system.|Measurements were taken after wearing the study prostheses for three weeks.|Each participant wore both study prostheses.||dimensionless||Standard Deviation|Mean
710768|NCT00167778|Primary|Local Dynamic Stability (Hip During Straight Walking)|Maximum finite-time Lyapunov exponents were used to estimate the local dynamic stability of the amputee’s sagittal plane hip, knee and ankle angles for their prosthetic limb with and without the torsion adapter while walking straight, while turning with the prosthesis on the inside of the turn, and while turning with the prosthesis on the outside of the turn. Maximum finite-time Lyapunov exponents measure the rate of kinematic separation of a gait cycle trajectory perturbed by naturally occurring disturbances and neuromuscular control errors. A positive exponent indicates divergence of a system, with increasing values indicating a les stable system.|Measurements were taken after wearing the study prostheses for three weeks.|Each participant wore both study prostheses.||dimensionless||Standard Deviation|Mean
710769|NCT00168038|Secondary|Maximum Platelet Level|Maximum absolute platelet count achieved over the duration of the study.|29 days|ITT analysis. The ITT population comprised all subjects who received at least once study medication.||10^9/L||Full Range|Median
710770|NCT00168038|Secondary|Duration of Platelet Response|The number of days the platelet count remained ≥ 50 x 10^9/L.|up to 29 days|Analyzed for responders in the ITT population, i.e., only subjects with at least one platelet measurement ≥ 50 x 10^9/L after start of treatment||days|Participants|Inter-Quartile Range|Median
710771|NCT00168038|Secondary|Time to Platelet Response|Median time to reach a platelet count ≥ 50 x 10^9/L.|29 days|ITT analysis. The ITT population comprised all subjects who received at least once study medication.||days||Inter-Quartile Range|Median
710772|NCT00168038|Secondary|Regression of Hemorrhage (Internal)|Number of subjects with a decrease in the severity of bleeding from baseline (prior to first infusion) on at least one post-infusion assessment during the study period (e.g., a change from moderate to mild or a change from mild to none). Regression of hemorrhages was tabulated separately for the organ systems skin, oral cavity, genitourinary tract, nose, and internal.|29 days|The number of participants analyzed represents the number of subjects in the ITT population with internal bleeding at baseline and respective post-baseline assessment.||participants|||Number
710773|NCT00168038|Secondary|Regression of Hemorrhage (Nose)|Number of subjects with a decrease in the severity of bleeding from baseline (prior to first infusion) on at least one post-infusion assessment during the study period (e.g., a change from moderate to mild or a change from mild to none). Regression of hemorrhages was tabulated separately for the organ systems skin, oral cavity, genitourinary tract, nose, and internal.|29 days|The number of participants analyzed represents the number of subjects in the ITT population with nose bleeding at baseline and respective post-baseline assessment.||participants|||Number
710774|NCT00168038|Secondary|Regression of Hemorrhage (Genitourinary Tract)|Number of subjects with a decrease in the severity of bleeding from baseline (prior to first infusion) on at least one post-infusion assessment during the study period (e.g., a change from moderate to mild or a change from mild to none). Regression of hemorrhages was tabulated separately for the organ systems skin, oral cavity, genitourinary tract, nose, and internal.|29 days|The number of participants analyzed represents the number of subjects in the ITT population with genitourinary tract bleeding at baseline and respective post-baseline assessment.||participants|||Number
710775|NCT00168038|Secondary|Regression of Hemorrhage (Oral Cavity)|Number of subjects with a decrease in the severity of bleeding from baseline (prior to first infusion) on at least one post-infusion assessment during the study period (e.g., a change from moderate to mild or a change from mild to none). Regression of hemorrhages was tabulated separately for the organ systems skin, oral cavity, genitourinary tract, nose, and internal.|29 days|The number of participants analyzed represents the number of subjects in the ITT population with oral cavity bleeding at baseline and respective post-baseline assessment.||participants|||Number
710776|NCT00168038|Secondary|Regression of Hemorrhage (Skin)|Number of subjects with a decrease in the severity of bleeding from baseline (prior to first infusion) on at least one post-infusion assessment during the study period (e.g., a change from moderate to mild or a change from mild to none). Regression of hemorrhages was tabulated separately for the organ systems skin, oral cavity, genitourinary tract, nose, and internal.|up to 29 days|The number of participants analyzed represents the number of subjects in the ITT population with skin bleeding at baseline and respective post-baseline assessment.||participants|||Number
710777|NCT00168038|Primary|Platelet Response|The platelet response rate is defined as the percentage of subjects responding to treatment with an increase of platelet count from ≤ 20 x 10^9/L to ≥ 50 x 10^9/L within the specified time frame.|7 days|Intention to treat (ITT) analysis. The ITT population comprised all subjects who received at least once study medication.||Percent of participants||95% Confidence Interval|Number
710778|NCT00168064|Secondary|Percent of Participants Achieving at Least 50% Improvement of Severity Weighted Assessment Tool (SWAT)|Assessment of lesion distribution and severity. A responder analysis was performed on whether subject achieved at least 50% improvement on scale. This had to be confirmed on at least one visit at least 4 weeks apart.|Baseline to end of therapy|||Percent of participants|||Number
710779|NCT00168064|Secondary|Severity-weighted Assessment Tool (SWAT) Within up to 12 Months by 2 or More Consecutive Observations Over at Least 4 Weeks||Assessment made at Day 1 and every subsequent visit during treatment||||||
710780|NCT00168064|Primary|Ratio of Response Rates Based on CAILS|The ratio of the response rate of the patients treated with the PG formulation to the response rate of the patients treated with the AP formulation. Skin response determined by at least a 50% reduction from baseline in the Composite Assessment of Index Lesion Severity (CAILS) following up to 12 months of treatment|Assessment made at Day 1 and every subsequent visit during treatment|ITT||percentage of participants|||Number
710781|NCT00168103|Secondary|Number of Vomiting Episodes||Within 4 h after start of study treatment|Analysis was based on the ITT population which included all subjects receiving any portion of the randomized study medication.||Episodes per subject||Full Range|Median
710782|NCT00168103|Other Pre-specified|Number of Subjects Receiving Rescue Study Medication||Within 4 h after start of study treatment|Analysis was based on the ITT population which included all subjects receiving any portion of the randomized study medication.||Subjects|||Number
710783|NCT00168103|Other Pre-specified|Time to Complete Resolution of All HAE Symptoms, Including Pain|Complete resolution of symptoms was determined by subject self-assessment.|Up to 24 h after start of study treatment|Analysis was based on the ITT population which included all subjects receiving any portion of the randomized study medication.||Hours||Full Range|Median
710784|NCT00168103|Secondary|Number of Subjects With Worsened Intensity of Clinical HAE Symptoms|Includes any worsening of intensity of at least 1 of the HAE symptoms present at baseline. Routinely checked symptoms included pain, nausea, vomiting, cramps, and diarrhea.|Baseline and between 2 and 4 h after start of study treatment|Analysis was based on the ITT population which included all subjects receiving any portion of the randomized study medication.||Subjects|||Number
710785|NCT00168103|Primary|Time to Start of Relief of Symptoms From HAE Attack|The start of symptom relief was determined by subject self-assessment. Time to start of symptom relief was set to 24 hours if the subject received rescue medication (blinded study medication, narcotic analgesics, antiemetics, open-label C1-INH, or fresh frozen plasma) at any time point after the start of study treatment but before start of relief.|Up to 24 h after start of study treatment|Analysis was based on the ITT population which included all subjects receiving any portion of the randomized study medication.||Hours||Full Range|Median
710786|NCT00168298|Secondary|Percentage of Patients With a Change From Baseline in BCVA by Category|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. Data are grouped into the following 5 categories based on change from baseline: ≥15 Letters Improvement, ≥5 and <15 Letters Improvement, No Change (Between -5 to +5 Letters), ≥5 and <15 Letters Worsening, and ≥15 Letters Worsening.|Baseline, Day 180|Intent-to-Treat: all randomized patients||Percentage of Patients|||Number
710787|NCT00168298|Secondary|Percentage of Patients With a Change From Baseline in BCVA by Category|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. Data are grouped into the following 5 categories based on change from baseline: ≥15 Letters Improvement, ≥5 and <15 Letters Improvement, No Change (Between -5 to +5 Letters), ≥5 and <15 Letters Worsening, and ≥15 Letters Worsening.|Baseline, Day 90|Intent-to-Treat: all randomized patients||Percentage of Patients|||Number
710788|NCT00168298|Secondary|Change From Baseline in Retinal Thickness in the Study Eye|Retinal thickness is assessed by optical coherence tomography (OCT) in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.|Baseline, Day 90, Day 180|Intent-to-Treat: all randomized patients||Microns (µm)||Standard Deviation|Mean
710789|NCT00168298|Primary|Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The numbers of patients with at least a 15 or more letter improvement in BCVA in the study eye are presented.|Day 180|Intent-to-Treat: all randomized patients||Number of Participants|||Number
710790|NCT00168311|Primary|Scale for the Asessment of Negative Symptoms (SANS)|Scale for Assessment of Negative Symptoms [SANS]. This is a semi structured interview. Assessments are conducted on a six-point scale (0=not at all to 5=severe)with a total score range of 0-70. A score of >50 is considered to be a moderate-severe intensity.|3 weeks|||Scores on a scale||Standard Deviation|Mean
710791|NCT00168324|Secondary|Percentage of Patients With a Change From Baseline in BCVA by Category|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. Data are grouped into the following 5 categories based on change from baseline: ≥15 Letters Improvement, ≥5 and <15 Letters Improvement, No Change (Between -5 to +5 Letters), ≥5 and <15 Letters Worsening, and ≥15 Letters Worsening.|Baseline, Day 180|Intent-to-Treat: all randomized patients||Percentage of Patients|||Number
710824|NCT00168805|Secondary|Blood Transfusion|Blood transfusion for treated and operated patients on Day of surgery.|Day 1|||participants|||Number
710792|NCT00168324|Secondary|Percentage of Patients With a Change From Baseline in BCVA by Category|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. Data are grouped into the following 5 categories based on change from baseline: ≥15 Letters Improvement, ≥5 and <15 Letters Improvement, No Change (Between -5 to +5 Letters), ≥5 and <15 Letters Worsening, and ≥15 Letters Worsening.|Baseline, Day 90|Intent-to-Treat: all randomized patients||Percentage of Patients|||Number
710793|NCT00168324|Primary|Cumulative Response Rate of 15 or More Letter Improvement|The cumulative response rate of 15 or more letter improvement was based on the Kaplan-Meier estimate. A Kaplan-Meier analysis takes into account patients who dropped out from the study prior to achieving the 15 letter improvement. Values ranged from 0-1, with a higher number indicating a higher probability of response.|Up to 180 Days|Intent-to-Treat: all randomized patients||Kaplan-Meier Estimate|||Number
710794|NCT00168324|Secondary|Change From Baseline in Retinal Thickness in the Study Eye|Retinal thickness is assessed by optical coherence tomography (OCT) in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.|Baseline, Day 90, Day 180|Intent-to-Treat: all randomized patients||Microns (µm)||Standard Deviation|Mean
710795|NCT00168324|Secondary|Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The numbers of patients with at least a 15 or more letter improvement in BCVA in the study eye at each visit are presented.|Day 90, Day 180|Intent-to-Treat: all randomized patients||Number of Participants|||Number
710796|NCT00168337|Post-Hoc|Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye at 3-month Intervals|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.|Baseline, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21, Month 24, Month 27, Month 30, Month 33, Month 36, Month 39/Final Visit|Intent to Treat: all randomized patients||Percentage of Patients|||Number
710797|NCT00168337|Post-Hoc|10th Percentile for Time to BCVA Improvement of ≥15 Letters From Baseline in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). Shorter durations of time to improvement are best. The 10th percentile represents the first 10% of patients to reach a BCVA improvement of ≥15 letters from baseline in the study eye.|Baseline, 39 Months|Intent to Treat: all randomized patients||Days|||Number
710798|NCT00168337|Secondary|Change From Baseline in Retinal Thickness as Measured by Optical Coherence Tomography (OCT)|OCT is a laser-based, noninvasive, diagnostic system that provides high-resolution, three-dimensional images of the retina from which retinal thickness can be measured. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.|Baseline, Month 39/Final Visit|Intent to Treat: all randomized patients||Microns||Standard Deviation|Mean
710799|NCT00168337|Secondary|Percentage of Patients With a BCVA Improvement of ≥10 Letters From Baseline in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.|Baseline, Month 39/Final Visit|Intent to Treat: all randomized patients||Percentage of Patients|||Number
710800|NCT00168337|Secondary|Change From Baseline in BCVA in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive number change from baseline indicates an improvement and a negative number change from baseline indicates a worsening.|Baseline, Month 39/Final Visit|Intent to Treat: all randomized patients||Letters||Standard Deviation|Mean
710801|NCT00168337|Secondary|Average Change From Baseline in BCVA in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The average BCVA is calculated across study visits for each patient. A positive number change from baseline indicates an improvement and a negative number change from baseline indicates a worsening.|Baseline, 39 Months|Intent to Treat: all randomized patients||Letters||Standard Deviation|Mean
710802|NCT00168337|Primary|Percentage of Patients With a Best Corrected Visual Acuity (BCVA) Improvement of ≥15 Letters From Baseline in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.|Baseline, Month 39/Final Visit|Intent to Treat: all randomized patients||Percentage of Patients|||Number
710803|NCT00168389|Secondary|Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye at 3-month Intervals|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.|Baseline, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21, Month 24, Month 27, Month 30, Month 33, Month 36, Month 39/Final Visit|Intent to Treat: all randomized patients||Percentage of Patients|||Number
710804|NCT00168389|Secondary|10th Percentile for Time to BCVA Improvement of ≥15 Letters From Baseline in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). Shorter durations of time to improvement are best. The 10th percentile represents the first 10% of patients to reach a BCVA improvement of ≥15 letters from baseline in the study eye.|Baseline, 39 Months|Intent to Treat: all randomized patients||Days|||Number
710805|NCT00168389|Secondary|Average Change From Baseline in Retinal Thickness as Measured by Optical Coherence Tomography (OCT)|OCT is a laser-based, noninvasive, diagnostic system that provides high-resolution, three-dimensional images of the retina from which retinal thickness can be measured. The average OCT retinal thickness is calculated across study visits for each patient. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.|Baseline, 39 Months|Intent to Treat: all randomized patients with data at the time point||Microns||Standard Deviation|Mean
710806|NCT00168389|Secondary|Percentage of Patients With a BCVA Improvement of ≥10 Letters From Baseline in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.|Baseline, Month 39/Final Visit|Intent to Treat: all randomized patients||Percentage of Patients|||Number
710807|NCT00168389|Secondary|Change From Baseline in BCVA in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive number change from baseline indicates an improvement and a negative number change from baseline indicates a worsening.|Baseline, Month 39/Final Visit|Intent to Treat: all randomized patients||Letters||Standard Deviation|Mean
710808|NCT00168389|Secondary|Average Change From Baseline in BCVA in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The average BCVA is calculated across study visits for each patient. A positive number change from baseline indicates an improvement and a negative number change from baseline indicates a worsening.|Baseline, 39 Months|Intent to Treat: all randomized patients||Letters||Standard Deviation|Mean
710809|NCT00168389|Primary|Percentage of Patients With a Best Corrected Visual Acuity (BCVA) Improvement of ≥15 Letters From Baseline in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.|Baseline, Month 39/Final Visit|Intent to Treat: all randomized patients||Percentage of Patients|||Number
710810|NCT00168428|Secondary|Percentage of Patients With Severe HIT-6 Impact Category Scores|Percentage of patients with a severe (60-78) score on the Headache Impact Test (HIT-6) Questionnaire during the 28 day period, ending with Week 24. The HIT-6 consisted of 6 questions about headache and impact on the patient's health and well-being. Answers for each question ranged from 6=Never, 8=Rarely, 10=Sometimes, 11=Very Often, and 13=Always. The total scores ranged from 36-49 (Little or No Impact), 50-55 (Some Impact), 56-59 (Substantial Impact) and 60-78 (Severe Impact).|Week 24|Intent to Treat||Percentage of Patients|||Number
710811|NCT00168428|Secondary|Change in Frequency of Headache Episodes|Mean change from baseline in frequency (number) of headache episodes during the 28 day period ending with Week 24. Headache episode defined as patient-reported headache with a start and stop time indicating that the pain lasted >= 4 continuous hours.|Baseline, Week 24|Intent to Treat||Headache Episodes||Standard Deviation|Mean
710812|NCT00168428|Secondary|Change in Frequency of Migraine/Probable Migraine Headache Days|Mean change from baseline in frequency (number) of migraine/probable migraine headache days during the 28 day period ending with Week 24. Headache day defined as a calendar day with >= 4 continuous hours of headache meeting the ICHD-II criteria for migraine or probable migraine.|Baseline, Week 24|Intent to Treat||Migraine/Probable Migraine Headache Days||Standard Deviation|Mean
710813|NCT00168428|Secondary|Change in Frequency of Moderate/Severe Headache Days|Mean change from baseline in frequency (number) of moderate/severe headache days during the 28 day period ending with Week 24. Those calendar days with >= 4 continuous hours of headache were selected. As per the patient diary, all headache episodes occurring during those days with a maximum severity of moderate or severe were counted.|Baseline, Week 24|Intent to Treat||Moderate/Severe Headache Days||Standard Deviation|Mean
710814|NCT00168428|Secondary|Change in Total Cumulative Hours of Headache Occurring on Headache Days|Mean change from baseline in total cumulative hours of headache occurring on headache days during the 28 day period ending with Week 24. Headache day defined as a calendar day [00:00 to 23:59] when the patient reported >= 4 continuous hours of headache.|Baseline, Week 24|Intent to Treat||Hours||Standard Deviation|Mean
710815|NCT00168428|Primary|Change in Frequency of Headache Days|Mean change from baseline in frequency (number) of headache days during the 28 day period ending with Week 24. Headache day defined as a calendar day [00:00 to 23:59] for which the patient reported >= 4 continuous hours of headache.|Baseline, Week 24|Intent to Treat||Headache Days||Standard Deviation|Mean
710816|NCT00168454|Post-Hoc|Percentage of Patients With 100% Reduction From Baseline of Urinary Urge Incontinence Episodes|Measured by the 7 day diary preceding each visit. Urinary urge incontinence is defined as urinary leakage associated with a strong desire to urinate.|Baseline, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36|Intent to Treat||Percentage of patients|||Number
710817|NCT00168454|Secondary|Incontinence Quality of Life Instrument (I-QOL)|Measured on 3 domains; a 5-point scale (1-5) for each domain. Sum of the domain scores is normalized to a scale of 0-100 (100 = no impact of incontinence on daily activities, 0 = maximum impact of incontinence on daily activities). Mean scores presented.|Baseline, Week 2, Week 6, Week 12|Intent to Treat||Units on a scale|||Number
710818|NCT00168454|Secondary|Maximum Cystometric Capacity (MCC) by Urodynamic Measurements|Maximum Cystometric Capacity (maximum volume that the bladder can hold) measured in mean milliliters|Baseline, Week 12|Intent to Treat||milliliters|||Number
710825|NCT00168805|Secondary|Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period|"Major bleeding events were defined as
fatal
clinically overt associated with loss of haemoglobin >=20g/L in excess of what was expected
clinically overt leading to the transfusion of >=2 units packed cells or whole blood in excess of what was expected
symptomatic retroperitoneal, intracranial, intraocular or intraspinal
requiring treatment cessation
leading to re-operation
Clinically-relevant was defined as
spontaneous skin hematoma greater than or equal to 25 cm²
wound hematoma greater than or equal to 100 cm²
spontaneous nose bleed lasting longer than 5 min
macroscopic hematuria spontaneous or lasting longer than 24 hours if associated with an intervention
spontaneous rectal bleeding (more than a spot on toilet paper)
gingival bleeding lasting longer than 5 min
any other bleeding event considered clinically relevant by the investigator
Minor bleeding events were defined as all other bleeding events that did not fulfil the criteria from above."|First administration until 6-10 days|Treated set||Participants|||Number
710826|NCT00168805|Secondary|Number of Participants With Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period|Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine bilateral venography), symptomatic DVT (confirmed by venous compression ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy).|3 months|Patients with any data available during follow-up||Participants|||Number
710827|NCT00168805|Secondary|Number of Participants Who Died During Treatment Period|All cause death, as adjudicated by the VTE events committee|First administration until 6-10 days|Full Analysis Set - op||Participants|||Number
710828|NCT00168805|Secondary|Number of Participants With Pulmonary Embolism During Treatment Period|Pulmonary embolism confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy, and as adjudicated by the VTE events committee|First administration until 6-10 days|Full Analysis Set - op||Participants|||Number
710829|NCT00168805|Secondary|Number of Participants With Symptomatic Deep Vein Thrombosis During Treatment Period|Symptomatic Deep Vein Thrombosis, confirmed by venous compression ultrasound, venography or autopsy, and as adjudicated by the VTE events committee|First administration until 6-10 days|Full Analysis Set - op (all patients who are treated and operated)||Participants|||Number
710830|NCT00168805|Secondary|Number of Participants With Total Deep Vein Thrombosis During Treatment Period|Total Deep Vein Thrombosis as adjudicated by the VTE events committee|First administration until 6-10 days|Full Analysis Set - tDVT (all patients who had surgery and were randomised, received treatment, had an evaluable venogram, or had confirmed symptomatic Deep Vein Thrombosis)||Participants|||Number
710831|NCT00168805|Secondary|Number of Participants With Proximal Deep Vein Thrombosis During Treatment Period|Proximal Deep Vein Thrombosis as adjudicated by the VTE events committee|First administration until 6-10 days|Full Analysis Set - pDVT (all patients who had surgery and were randomised, received treatment, had an evaluable venogram for proximal Deep Vein Thrombosis, or had confirmed symptomatic Deep Vein Thrombosis)||Participants|||Number
710832|NCT00168805|Secondary|Number of Participants With Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period|Major Venous Thromboembolic Event (VTE) is defined as proximal DVT and PE, as adjudicated by the VTE events committee|First administration until 6-10 days|Full Analysis Set - major (all patients who had surgery and were randomised, received treatment, had an evaluable venogram for proximal Deep Vein Thrombosis, or had confirmed symptomatic Deep Vein Thrombosis, Pulmonary Embolism, or had died by a Venous Thromboembolic Event-related death)||Participants|||Number
710833|NCT00168805|Primary|Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period|"Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine bilateral venography), symptomatic DVT (confirmed by venous compression ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy).
All of these components and all deaths were centrally adjudicated by the VTE events committee, which was not aware of the treatment allocation of the patients."|First administration until 6-10 days|Full Analysis Set (all patients who had surgery and were randomised, received treatment, had an evaluable venogram for distal and proximal Deep Vein Thrombosis, or had confirmed symptomatic Deep Vein Thrombosis, Pulmonary Embolism, or had died)||Participants|||Number
710834|NCT00168818|Secondary|Laboratory Analyses|Frequency of patients with possible clinically significant abnormalities.|First administration to end of study|Treated patients||participants|||Number
710835|NCT00168818|Secondary|Volume of Blood Loss|Volume of blood loss for treated and operated patients during surgery.|Day 1|||mL||Standard Deviation|Mean
710836|NCT00168818|Secondary|Blood Transfusion|Blood transfusion for treated and operated patients on Day of surgery.|Day 1|||participants|||Number
710837|NCT00168818|Secondary|Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period|"Major bleeding events were defined as
fatal
clinically overt associated with loss of haemoglobin >=20g/L in excess of what was expected
clinically overt leading to the transfusion of >=2 units packed cells or whole blood in excess of what was expected
symptomatic retroperitoneal, intracranial, intraocular or intraspinal
requiring treatment cessation
leading to re-operation
Clinically-relevant was defined as
spontaneous skin hematoma greater than or equal to 25 cm²
wound hematoma greater than or equal to 100 cm²
spontaneous nose bleed lasting longer than 5 min
macroscopic hematuria spontaneous or lasting longer than 24 hours if associated with an intervention
spontaneous rectal bleeding (more than a spot on toilet paper)
gingival bleeding lasting longer than 5 min
any other bleeding event considered clinically relevant by the investigator
Minor bleeding events were defined as all other bleeding events that did not fulfil the criteria from above."|First administration until 31-38 days|Treated set||Participants|||Number
710838|NCT00168818|Secondary|Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period|Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine bilateral venography), symptomatic DVT (confirmed by venous compression ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy).|end of treatment to day 91±7|Patients with any data available during follow-up||Participants|||Number
710840|NCT00168818|Secondary|Pulmonary Embolism During Treatment Period|Pulmonary embolism confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy, and as adjudicated by the VTE events committee|First administration until 31-38 days|Full Analysis Set - op (all patients who are treated and operated)||Participants|||Number
710841|NCT00168818|Secondary|Symptomatic Deep Vein Thrombosis During Treatment Period|Symptomatic Deep Vein Thrombosis, confirmed by venous compression ultrasound, venography or autopsy, and as adjudicated by the VTE events committee|First administration until 31-38 days|Full Analysis Set - op (all patients who are treated and operated)||Participants|||Number
710842|NCT00168818|Secondary|Total Deep Vein Thrombosis During Treatment Period|Total Deep Vein Thrombosis as adjudicated by the VTE events committee|First administration until 31-38 days|Full Analysis Set - tDVT (all patients who had surgery and were randomised, received treatment, had an evaluable venogram, or had confirmed symptomatic Deep Vein Thrombosis)||Participants|||Number
710843|NCT00168818|Secondary|Proximal Deep Vein Thrombosis During Treatment Period|Proximal Deep Vein Thrombosis as adjudicated by the VTE events committee|First administration until 31-38 days|Full Analysis Set - pDVT (all patients who had surgery and were randomised, received treatment, had an evaluable venogram for proximal Deep Vein Thrombosis, or had confirmed symptomatic Deep Vein Thrombosis)||Participants|||Number
710844|NCT00168818|Secondary|Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period|Major Venous Thromboembolic Event (VTE) is defined as proximal DVT and PE, as adjudicated by the VTE events committee|First administration until 31-38 days|Full Analysis Set - major (all patients who had surgery and were randomised, received treatment, had an evaluable venogram for proximal Deep Vein Thrombosis, or had confirmed symptomatic Deep Vein Thrombosis, Pulmonary Embolism, or had died by a Venous Thromboembolic Event-related death)||Participants|||Number
710845|NCT00168818|Primary|Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period|"Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine bilateral venography), symptomatic DVT (confirmed by venous compression ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy).
All of these components and all deaths were centrally adjudicated by the VTE events committee, which was not aware of the treatment allocation of the patients."|First administration until 31-38 days|Full Analysis Set (all patients who had surgery and were randomised, received treatment, had an evaluable venogram for distal and proximal Deep Vein Thrombosis, or symptomatic Deep Vein Thrombosis, Pulmonary Embolism, or had died)||Participants|||Number
710846|NCT00168831|Secondary|PGR Scores|Patient's Global rating (PGR) scores over the treatment period. Scale: 1=much better to 7=much worse The means are adjusted for centre, smoking status at entry and baseline value.|Week 48|Full Analysis Set - Patient's Global Rating (FAS-PGR)||Points on a scale||Standard Error|Mean
710847|NCT00168831|Secondary|PGE Scores|Physician's Global evaluation (PGE) scores over the treatment period. Scale: 1−2 = Poor, 3−4 = Fair, 5−6 = Good, 7−8 = Excellent The means are adjusted for centre, smoking status at entry and baseline value.|Week 48|Full Analysis Set - Physician's Global Evaluation (FAS-PGE)||Points on a scale||Standard Error|Mean
710848|NCT00168831|Secondary|COPD Symptoms Scores|"COPD symptoms Scores - wheezing, shortness of breath, coughing and tightness of chest over the treatment period.
Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe The means are adjusted for centre, smoking status at entry and baseline value."|Week 48|Full Analysis Set - COPD symptoms (FAS-SYM)||Points on a scale||Standard Error|Mean
710849|NCT00168831|Secondary|Saint George's Respiratory Questionnaire (SGRQ) Scores|"Saint George's Respiratory Questionnaire (SGRQ) Scores impacts, activities and symptoms. Worst score = 100, best score = 0.
The means are adjusted for centre, smoking status at entry and baseline value."|Week 48|Full Analysis Set - Saint George's Respiratory Questionnaire (FAS-QOL)||Points on a scale||Standard Error|Mean
710850|NCT00168831|Secondary|Mahler TDI Scores|"Mahler Transitional Dyspnoea Index (TDI) scores measured as change in functional impairment, change in magnitude of tasks and change in magnitude of efforts over the treatment period. The means are adjusted for centre, smoking status at entry and baseline value.
Worst score = -3, best score = +3"|Week 48|Full Analysis Set - Transitional Dyspnoea Index (FAS-TDI)||Points on a scale||Standard Error|Mean
710851|NCT00168831|Secondary|Weekly Mean Number of Puffs of Rescue Medication Per Day|Weekly mean number of puffs of rescue medication used per day as required (PRN salbutamol). The means are adjusted for centre, smoking status at entry, and baseline value.|Weeks 2, 8, 16, 24, 32, 40, 48|Full Analysis Set - Diary (FAS-DRY)||Puffs||Standard Error|Mean
710852|NCT00168831|Secondary|Weekly Mean Morning Evening PEFRs|Weekly mean evening peak expiratory flow rates (PEFRs). The means are adjusted for centre, smoking status at entry, and baseline value.|Weeks 2, 8, 16, 24, 32, 40, 48|Full Analysis Set - Diary (FAS-DRY)||Litres/minute||Standard Error|Mean
710853|NCT00168831|Secondary|Weekly Mean Morning Pre-dose PEFRs|Weekly mean morning pre-dose peak expiratory flow rates (PEFRs). The means are adjusted for centre, smoking status at entry, and baseline value.|Weeks 2, 8, 16, 24, 32, 40, 48|Full Analysis Set - Diary (FAS-DRY)||Litres/minute||Standard Error|Mean
710854|NCT00168831|Secondary|Change From Baseline in FVC AUC0-3 After 2, 8, 16, 24, 32, 40 and 48 Weeks|FVC AUC0-3 represents the Area under Curve over the time interval from 0 to 3 hours after 2, 8, 16, 24, 32, 40 and 48 weeks. The means are adjusted for centre, smoking status at entry and baseline value.|10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication|Full Analysis Set - Clinic Spirometry (FAS-PFT)||Litres||Standard Error|Mean
710855|NCT00168831|Secondary|Change From Baseline in FEV1 AUC0-3 After 2, 8, 16, 24, 32, 40 and 48 Weeks|FEV1 AUC0-3 represents the Area under Curve over the time interval from 0 to 3 hours after 2, 8, 16, 24, 32, 40 and 48 weeks. The means are adjusted for centre, smoking status at entry and baseline value.|10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication|Full Analysis Set - Clinic Spirometry (FAS-PFT)||Litres||Standard Error|Mean
710856|NCT00168831|Secondary|Change From Baseline in Trough FVC After 2, 8, 16, 24, 32, 40 and 48 Weeks|Change From Baseline in Trough Forced vital capacity (FVC) after 2, 8, 16, 24, 32, 40 and 48 weeks. The means are adjusted for centre, smoking status at entry and baseline value.|10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication|Full Analysis Set - Clinic Spirometry (FAS-PFT)||Litres||Standard Error|Mean
710857|NCT00168831|Secondary|Change From Baseline in Trough FEV1 After 2, 8, 16, 24, 32 and 40 Weeks|Change From Baseline in Trough Forced Expiratory Volume in 1 second (FEV1) after 2, 8, 16, 24, 32 and 40 weeks. The means are adjusted for centre, smoking status at entry and baseline value.|10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication|Full Analysis Set - Clinic Spirometry (FAS-PFT)||Litres||Standard Error|Mean
710858|NCT00168831|Secondary|Change From Baseline in Albumin|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||g/L||Standard Deviation|Mean
710859|NCT00168831|Secondary|Change From Baseline in Protein, Total|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||grams per litre (g/L)||Standard Deviation|Mean
710860|NCT00168831|Secondary|Change From Baseline in Uric Acid|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||umol/L||Standard Deviation|Mean
710861|NCT00168831|Secondary|Change From Baseline in Bilirubin, Total|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||umol/L||Standard Deviation|Mean
710862|NCT00168831|Secondary|Change From Baseline in Creatinine|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||micromoles per litre (umol/L)||Standard Deviation|Mean
710863|NCT00168831|Secondary|Change From Baseline in Blood Urea Nitrogen|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||milligrams per decilitre (mg/dL)||Standard Deviation|Mean
710864|NCT00168831|Secondary|Change From Baseline in Urea|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||mmol/L||Standard Deviation|Mean
710865|NCT00168831|Secondary|Change From Baseline in Glucose|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||mmol/L||Standard Deviation|Mean
710866|NCT00168831|Secondary|Change From Baseline in Lactic Dehyrogenase (LDH)|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||U/L||Standard Deviation|Mean
710867|NCT00168831|Secondary|Change From Baseline in Alkaline Phosphatase|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||U/L||Standard Deviation|Mean
710868|NCT00168831|Secondary|Change From Baseline in Alanine Transaminase/Glutamic Pyruvate Transaminase (ALT/GPT), Serum Glutamate Pyruvate Transaminase (SGPT)|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||U/L||Standard Deviation|Mean
710869|NCT00168831|Secondary|Change From Baseline in Aspartate Transaminase/Glutamic-oxaloacetic Transaminase (AST/GOT), Serum Glutamic-oxaloacetic Transaminase (SGOT)|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||Units per litre (U/L)||Standard Deviation|Mean
710870|NCT00168831|Secondary|Change From Baseline in Phosphate|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||mmol/L||Standard Deviation|Mean
710871|NCT00168831|Secondary|Change From Baseline in Calcium|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||millimoles per litre (mmol/L)||Standard Deviation|Mean
710872|NCT00168831|Secondary|Change From Baseline in Monocytes (Absolute)|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||10^9/L||Standard Deviation|Mean
710873|NCT00168831|Secondary|Change From Baseline in Lymphocytes (Absolute)|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||10^9/L||Standard Deviation|Mean
710874|NCT00168831|Secondary|Change From Baseline in Basophils (Absolute)|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||10^9/L||Standard Deviation|Mean
710875|NCT00168831|Secondary|Change From Baseline in Eosinophils (Absolute)|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||10^9/L||Standard Deviation|Mean
710876|NCT00168831|Secondary|Change From Baseline in Neutrophils (Absolute)|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||10^9/L||Standard Deviation|Mean
710877|NCT00168831|Secondary|Change From Baseline in Monocytes|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||percentage of white blood cell count||Standard Deviation|Mean
710878|NCT00168831|Secondary|Change From Baseline in Lymphocytes|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||percentage of white blood cell count||Standard Deviation|Mean
710879|NCT00168831|Secondary|Change From Baseline in Basophils|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||percentage of white blood cell count||Standard Deviation|Mean
710880|NCT00168831|Secondary|Change From Baseline in Eosinophils|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||percentage of white blood cell count||Standard Deviation|Mean
710881|NCT00168831|Secondary|Change From Baseline in Neutrophils|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||percentage of white blood cell count||Standard Deviation|Mean
710882|NCT00168831|Secondary|Change From Baseline in Platelets|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||10^9/L||Standard Deviation|Mean
710883|NCT00168831|Secondary|Change From Baseline in White Blood Cell Count|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||10^9/Litre (L)||Standard Deviation|Mean
710884|NCT00168831|Secondary|Change From Baseline in Red Blood Cell Count|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||10^12/Litre (L)||Standard Deviation|Mean
710885|NCT00168831|Secondary|Change From Baseline in Haemoglobin|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||grams per litre (g/L)||Standard Deviation|Mean
710886|NCT00168831|Secondary|Change From Baseline in Haematocrit, Packed Cell Volume (PCV)||Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||Percentage of erythrocytes||Standard Deviation|Mean
710887|NCT00168831|Secondary|Change From Baseline in VPB Pairs|Week 40 - baseline|Baseline to Week 40|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)||pairs per 24 hours||Standard Deviation|Mean
710888|NCT00168831|Secondary|Change From Baseline in Ventricular Premature Beat (VPB) Run Events|Week 40 - baseline|Baseline to Week 40|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)||events per 24 hours||Standard Deviation|Mean
710889|NCT00168831|Secondary|Change From Baseline in Ventricular Premature Beat (VPB) Total|Week 40 - baseline|Baseline to Week 40|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)||premature beats per 24 hours||Standard Deviation|Mean
710890|NCT00168831|Secondary|Change From Baseline in SVPB Pairs|Week 40 - baseline|Baseline to Week 40|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)||pairs per 24 hours||Standard Deviation|Mean
710891|NCT00168831|Secondary|Change From Baseline in SVPB Run Events|Week 40 - baseline|Baseline to Week 40|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)||events per 24 hours||Standard Deviation|Mean
710892|NCT00168831|Secondary|Change From Baseline in Supraventricular Premature Beat (SVPB) Total|Week 40 - baseline|Baseline to Week 40|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)||premature beats per 24 hours||Standard Deviation|Mean
710893|NCT00168831|Secondary|Change From Baseline in Heart Rate|Week 40 - baseline|Baseline to Week 40|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)||bpm||Standard Deviation|Mean
710894|NCT00168831|Secondary|Change From Baseline in QT Interval (Fridericia)|Week 40 pre-dose - baseline|Baseline to Week 40 pre-dose|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)||msec||Standard Deviation|Mean
710895|NCT00168831|Secondary|Change From Baseline in QT Interval (Bazett)|Week 40 pre-dose - baseline|Baseline to Week 40 pre-dose|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)||msec||Standard Deviation|Mean
710896|NCT00168831|Secondary|Change From Baseline in QT Interval|Week 40 pre-dose - baseline|Baseline to Week 40 pre-dose|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)||msec||Standard Deviation|Mean
710897|NCT00168831|Secondary|Change From Baseline in QRS Interval|Week 40 pre-dose - baseline|Baseline to Week 40 pre-dose|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)||msec||Standard Deviation|Mean
710898|NCT00168831|Secondary|Change From Baseline in PR Interval||Baseline to Week 40 pre-dose|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead electrocardiogram (ECG) and 24-hour Holter monitoring performed (see protocol and clinical trial report)||milliseconds (msec)||Standard Deviation|Mean
710899|NCT00168831|Secondary|Change From Baseline in Heart Rate|Week 40 pre-dose - baseline|Baseline to Week 40 pre-dose|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead electrocardiogram (ECG) and 24-hour Holter monitoring performed (see protocol and clinical trial report)||beats per minute (bpm)||Standard Deviation|Mean
710900|NCT00168831|Primary|COPD Exacerbation Rate, Safety Set (SS) (Combined Studies)|"Number of Chronic Obstructive Pulmonary Disease (COPD) exacerbations per patient year
For this endpoint data of the twin studies NCT00168844 and NCT00168831 was combined."|48 weeks|Safety Set. Combined analysis of studies NCT00168844 and NCT00168831. 670 patients analysed in total comprises 338 patients from NCT00168831 and 332 patients from study NCT00168844, 667 patients - 335 and 332, 653 patients - 334 and 319 respectively.||Number of exacerbations per patient year||Standard Deviation|Mean
710901|NCT00168831|Primary|TDI Focal Score, Full Analysis Set - Transitional Dyspnoea Index (FAS-TDI) (Combined Studies)|"Rating scale of 3 components - change in functional impairment, change in magnitude of tasks, change in magnitude of efforts. Worst score = -9, best score = +9
For this endpoint data of twin studies NCT00168844 and NCT00168831 was combined."|Week 48|Full Analysis Set - Transitional Dyspnoea Index (FAS-TDI)||Points on a scale||Standard Error|Mean
710902|NCT00168831|Primary|Saint George's Respiratory Questionnaire (SGRQ) Total Score, Full Analysis Set - Saint George's Respiratory Questionnaire (FAS-QOL)|Rating scale of 3 domains - symptoms, activities and impact (weighted). Worst score = 100, best score = 0|Week 48|Full Analysis Set - Saint George's Respiratory Questionnaire (FAS-QOL)||Points on a scale||Standard Error|Mean
710903|NCT00168831|Primary|Change From Baseline in Trough FEV1 After 48 Weeks|Change From Baseline in Trough Forced Expiratory Volume in 1 second (FEV1) after 48 weeks|10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication|Full Analysis Set - Clinic Spirometry (FAS-PFT)||Litres||Standard Error|Mean
710904|NCT00168844|Secondary|PGR Score|"Patient's Global rating (PGR) score over the treatment period. Scale: 1=much better to 7=much worse
The means are adjusted for centre, smoking status at entry and baseline value."|Week 48|Full Analysis Set - Patient's Global Rating (FAS-PGR)||Points on a scale||Standard Error|Mean
710905|NCT00168844|Secondary|PGE Scores|"Physician's Global evaluation (PGE) scores over the treatment period. Scale: 1−2 = Poor, 3−4 = Fair, 5−6 = Good, 7−8 = Excellent
The means are adjusted for centre, smoking status at entry and baseline value."|Week 48|Full Analysis Set - Physician's Global Evaluation (FAS-PGE)||Points on a scale||Standard Error|Mean
710906|NCT00168844|Secondary|COPD Symptoms Scores|"COPD symptoms Scores - wheezing, shortness of breath, coughing and tightness of chest over the treatment period. Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe
The means are adjusted for centre, smoking status at entry and baseline value."|Week 48|Full Analysis Set - COPD symptoms (FAS-SYM)||Points on a scale||Standard Error|Mean
710944|NCT00168844|Secondary|Change From Baseline in Haematocrit, Packed Cell Volume (PCV)|Volume of red cells (erythrocytes) in blood, expressed as a fraction (percentage) of the total volume of blood|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||Percentage of erythrocytes||Standard Deviation|Mean
710907|NCT00168844|Secondary|Saint George's Respiratory Questionnaire (SGRQ) Scores|"Saint George's Respiratory Questionnaire (SGRQ) Scores impacts, activities and symptoms. Worst score = 100, best score = 0.
The means are adjusted for centre, smoking status at entry and baseline value."|Week 48|Full Analysis Set - Saint George's Respiratory Questionnaire (FAS-QOL)||Points on a scale||Standard Error|Mean
710908|NCT00168844|Secondary|Mahler TDI Scores|"Mahler Transitional Dyspnoea Index (TDI) scores measured as change in functional impairment, change in magnitude of tasks and change in magnitude of efforts over the treatment period. The means are adjusted for centre, smoking status at entry and baseline value.
Worst score = -3, best score = +3"|Week 48|Full Analysis Set - Transitional Dyspnoea Index (FAS-TDI)||Points on a scale||Standard Error|Mean
710909|NCT00168844|Secondary|Weekly Mean Number of Puffs of Rescue Medication Per Day|Weekly mean number of puffs of rescue medication used per day as required (PRN salbutamol). The means are adjusted for centre, smoking status at entry, and baseline value.|Weeks 2, 8, 16, 24, 32, 40, 48|Full Analysis Set - Diary (FAS-DRY)||Puffs||Standard Error|Mean
710910|NCT00168844|Secondary|Weekly Mean Evening PEFRs|Weekly mean evening peak expiratory flow rates (PEFRs). The means are adjusted for centre, smoking status at entry, and baseline value.|Weeks 2, 8, 16, 24, 32, 40, 48|Full Analysis Set - Diary (FAS-DRY)||Litres/minute||Standard Error|Mean
710911|NCT00168844|Secondary|Weekly Mean Morning Pre-dose PEFRs|Weekly mean morning pre-dose peak expiratory flow rates (PEFRs). The means are adjusted for centre, smoking status at entry, and baseline value.|Weeks 2, 8, 16, 24, 32, 40, 48|Full Analysis Set - Diary (FAS-DRY)||Litres/minute||Standard Error|Mean
710912|NCT00168844|Secondary|Change From Baseline in FVC AUC0-3 After 2, 8, 16, 24, 32, 40 and 48 Weeks|FVC AUC0-3 represents the Area under Curve over the time interval from 0 to 3 hours after 2, 8, 16, 24, 32, 40 and 48 weeks. The means are adjusted for centre, smoking status at entry and baseline value.|10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication|Full Analysis Set - Clinic Spirometry (FAS-PFT)||Litres||Standard Error|Mean
710913|NCT00168844|Secondary|Change From Baseline in FEV1 AUC0-3 After 2, 8, 16, 24, 32, 40 and 48 Weeks|FEV1 AUC0-3 represents the Area under Curve over the time interval from 0 to 3 hours after 2, 8, 16, 24, 32, 40 and 48 weeks. The means are adjusted for centre, smoking status at entry and baseline value.|10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication|Full Analysis Set - Clinic Spirometry (FAS-PFT)||Litres||Standard Error|Mean
710914|NCT00168844|Secondary|Change From Baseline in Trough FVC After 2, 8, 16, 24, 32, 40 and 48 Weeks|Change From Baseline in Trough Forced vital capacity (FVC) after 2, 8, 16, 24, 32, 40 and 48 weeks. The means are adjusted for centre, smoking status at entry and baseline value.|10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication|Full Analysis Set - Clinic Spirometry (FAS-PFT)||Litres||Standard Error|Mean
710915|NCT00168844|Secondary|Change From Baseline in Trough FEV1 After 2, 8, 16, 24, 32 and 40 Weeks|Change From Baseline in Trough Forced Expiratory Volume in 1 second (FEV1) after 2, 8, 16, 24, 32 and 40 weeks. The means are adjusted for centre, smoking status at entry and baseline value.|10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication|Full Analysis Set - Clinic Spirometry (FAS-PFT)||Litres||Standard Error|Mean
710916|NCT00168844|Secondary|Change From Baseline in Albumin|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||g/L||Standard Deviation|Mean
710917|NCT00168844|Secondary|Change From Baseline in Protein, Total|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||grams per litre (g/L)||Standard Deviation|Mean
710918|NCT00168844|Secondary|Change From Baseline in Uric Acid|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||umol/L||Standard Deviation|Mean
710919|NCT00168844|Secondary|Change From Baseline in Bilirubin, Total|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||umol/L||Standard Deviation|Mean
710920|NCT00168844|Secondary|Change From Baseline in Creatinine|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||micromoles per litre (umol/L)||Standard Deviation|Mean
710921|NCT00168844|Secondary|Change From Baseline in Blood Urea Nitrogen|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||milligrams per decilitre (mg/dL)||Standard Deviation|Mean
710922|NCT00168844|Secondary|Change From Baseline in Urea|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||mmol/L||Standard Deviation|Mean
710923|NCT00168844|Secondary|Change From Baseline in Glucose|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||mmol/L||Standard Deviation|Mean
710924|NCT00168844|Secondary|Change From Baseline in Lactic Dehydrogenase (LDH)|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||U/L||Standard Deviation|Mean
710925|NCT00168844|Secondary|Change From Baseline in Alkaline Phosphatase|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||U/L||Standard Deviation|Mean
710926|NCT00168844|Secondary|Change From Baseline in Alanine Transaminase (ALT)/Glutamic Pyruvic Transaminase (GPT), Serum GPT (SGPT)|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||U/L||Standard Deviation|Mean
710927|NCT00168844|Secondary|Change From Baseline in Aspartate Transaminase (AST)/Glutamic-Oxaloacetic Transaminase (GOT), Serum GOT (SGOT)|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||Units per litre (U/L)||Standard Deviation|Mean
710928|NCT00168844|Secondary|Change From Baseline in Phosphate|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||mmol/L||Standard Deviation|Mean
710929|NCT00168844|Secondary|Change From Baseline in Calcium|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||millimoles per litre (mmol/L)||Standard Deviation|Mean
710930|NCT00168844|Secondary|Change From Baseline in Monocytes (Absolute)|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||10^9/L||Standard Deviation|Mean
710931|NCT00168844|Secondary|Change From Baseline in Basophils (Absolute)|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||10^9/L||Standard Deviation|Mean
710945|NCT00168844|Secondary|Change From Baseline in VPB Pairs|Week 40 - baseline|Baseline to Week 40|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)||pairs per 24 hours||Standard Deviation|Mean
710946|NCT00168844|Secondary|Change From Baseline in VPB Run Events|Week 40 - baseline|Baseline to Week 40|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)||events per 24 hours||Standard Deviation|Mean
710947|NCT00168844|Secondary|Change From Baseline in Ventricular Premature Beat (VPB) Total|Week 40 - baseline|Baseline to Week 40|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)||premature beats per 24 hours||Standard Deviation|Mean
710948|NCT00168844|Secondary|Change From Baseline in SVPB Pairs|Week 40 - baseline|Baseline to Week 40|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)||pairs per 24 hours||Standard Deviation|Mean
710949|NCT00168844|Secondary|Holter (24-hour Period) - SVPB (Supraventricular Premature Beat) Run Events Change From Baseline in Supraventricular Premature Beat (SVPB) Run Events|Week 40 - baseline|Baseline to Week 40|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)||events per 24 hours||Standard Deviation|Mean
710950|NCT00168844|Secondary|Change From Baseline in Supraventricular Premature Beat (SVPB) Total|Week 40 - baseline|Baseline to Week 40|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)||premature beats per 24 hours||Standard Deviation|Mean
710951|NCT00168844|Secondary|Change From Baseline in Heart Rate|Week 40 - baseline|Baseline to Week 40|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)||bpm||Standard Deviation|Mean
710952|NCT00168844|Secondary|Change From Baseline in QT Interval (Fridericia)|Week 40 pre-dose - baseline|Baseline to Week 40 pre-dose|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)||msec||Standard Deviation|Mean
710953|NCT00168844|Secondary|Change From Baseline in QT Interval (Bazett)|Week 40 pre-dose - baseline|Baseline to Week 40 pre-dose|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)||msec||Standard Deviation|Mean
710954|NCT00168844|Secondary|Change From Baseline in QT Interval|Week 40 pre-dose - baseline|Baseline to Week 40 pre-dose|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)||msec||Standard Deviation|Mean
710955|NCT00168844|Secondary|Change From Baseline in QRS Interval|Week 40 pre-dose - baseline|Baseline to Week 40 pre-dose|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)||msec||Standard Deviation|Mean
710956|NCT00168844|Secondary|Change From Baseline in PR Interval||Baseline to Week 40 pre-dose|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)||milliseconds (msec)||Standard Deviation|Mean
710957|NCT00168844|Secondary|Change From Baseline in Heart Rate|Week 40 pre-dose - baseline|Baseline to Week 40 pre-dose|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead electrocardiogram (ECG) and 24-hour Holter monitoring performed (see protocol and clinical trial report)||beats per minute (bpm)||Standard Deviation|Mean
710958|NCT00168844|Primary|COPD Exacerbation Rate, Safety Set (SS) (Combined Studies)|"Number of Chronic Obstructive Pulmonary Disease (COPD) exacerbations per patient year.
For this endpoint data of the twin studies NCT00168844 and NCT00168831 was combined."|48 weeks|Safety Set. Combined analysis of studies NCT00168844 and NCT00168831. 670 patients analysed in total comprises 338 patients from NCT00168831 and 332 patients from study NCT00168844, 667 patients - 335 and 332, 653 patients - 334 and 319 respectively.||Number of exacerbations per patient year||Standard Deviation|Mean
710959|NCT00168844|Primary|TDI Focal Score, Full Analysis Set - Transitional Dyspnoea Index (FAS-TDI) (Combined Studies)|"Rating scale of 3 components - change in functional impairment, change in magnitude of tasks, change in magnitude of efforts. Worst score = -9, best score = +9
For this endpoint data of twin studies NCT00168844 and NCT00168831 was combined."|Week 48|Full Analysis Set - Transitional Dyspnoea Index (FAS-TDI)||Points on a scale||Standard Error|Mean
710960|NCT00168844|Primary|Saint George's Respiratory Questionnaire (SGRQ) Total Score, Full Analysis Set - Saint George's Respiratory Questionnaire (FAS-QOL)|Rating scale of 3 domains - symptoms, activities and impact (weighted). Worst score = 100, best score = 0|Week 48|Full Analysis Set - Saint George's Respiratory Questionnaire (FAS-QOL)||Points on a scale||Standard Error|Mean
710961|NCT00168844|Primary|Change From Baseline in Trough FEV1 at Week 48, Full Analysis Set - Clinic Spirometry (FAS-PFT)|Trough Forced Expiratory Volume in 1 second (FEV1)|10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication|Full Analysis Set - Clinic Spirometry (FAS-PFT)||Litres||Standard Error|Mean
710962|NCT00169442|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Month 0 to Month 9.5)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.||Participants|||Count of Participants
710988|NCT00169442|Primary|Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T)|A seroprotected subject was defined as a vaccinated subject, with anti-D and anti-T antibody concentrations equal to or above (≥) 0.1 International Units per milliliter (IU/mL).|At Month 1, post-booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.||Participants|||Count of Participants
710963|NCT00169442|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-Day (Day 0-30) follow-up period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.||Participants|||Count of Participants
710964|NCT00169442|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.|Assessed solicited general symptoms were drowsiness, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Grade 3 irritability = crying that could not be comforted and prevented normal activity. Grade 3 loss of appetite = not eating at all. Related = symptom assessed by the investigator as related to the vaccination.|During the 4-Day (Days 0-3) post-booster vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptoms sheet filled in.||Participants|||Count of Participants
710965|NCT00169442|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms.|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.|During the 4-Day (Days 0-3) post-booster vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptoms sheet filled in.||Participants|||Count of Participants
710966|NCT00169442|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Grade 3 irritability = crying that could not be comforted and prevented normal activity. Grade 3 loss of appetite = not eating at all. Related = symptom assessed by the investigator as related to the vaccination.|During the 4-Day (Days 0-3) post-PRP challenge|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptoms sheet filled in.||Participants|||Count of Participants
710967|NCT00169442|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.|During the 4-Day (Days 0-3) post-PRP challenge|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptoms sheet filled in.||Participants|||Count of Participants
710968|NCT00169442|Secondary|Anti-BPT Antibody Concentrations.|Anti-BPT antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL), as assessed by ELISA.|At Month 0, prior to the PRP challenge|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
710969|NCT00169442|Secondary|Anti-HBs Antibody Concentrations.|Anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL), as assessed by ELISA.|At Month 0, prior to the PRP challenge|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.||mIU/mL||95% Confidence Interval|Geometric Mean
710970|NCT00169442|Secondary|Anti-D and Anti-T Antibody Concentrations.|Anti-D and anti-T antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in International Units per milliliter (IU/mL), as assessed by ELISA.|At Month 0, prior to the PRP challenge|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.||IU/mL||95% Confidence Interval|Geometric Mean
710971|NCT00169442|Secondary|Anti- PRP Antibody Concentrations.|Anti-PRP antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in microgram per milliliter (μg/mL), as assessed by ELISA.|At Month 0, prior to the PRP challenge|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.||μg/mL||95% Confidence Interval|Geometric Mean
710972|NCT00169442|Secondary|Anti- PRP Antibody Concentrations|Anti-PRP antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in microgram per milliliter (μg/mL), as assessed by ELISA.|At Month 0, prior to the PRP challenge|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.||μg/mL||95% Confidence Interval|Geometric Mean
710973|NCT00169442|Secondary|Number of Subjects With Anti-BPT Antibody Concentrations ≥ the Cut-off Value|The number of subjects with anti-BPT antibody concentrations equal to or above (≥) the cut-off value of 15 EL.U/mL, prior to the booster vaccination.|At Month 0, prior to the PRP challenge|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.||Participants|||Count of Participants
710974|NCT00169442|Secondary|Number of Subjects With Anti-HBs Antibody Concentrations ≥ the Cut-off Value|The number of subjects with anti-HBs antibody concentrations equal to or above (≥) the cut-off value of 10 mIU/mL, prior to the booster vaccination.|At Month 0, prior to the PRP challenge|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.||Participants|||Count of Participants
716601|NCT00261443|Secondary|Median Baseline Eosinophils (Relative) and Neutrophils (Relative)||Baseline|Phase 2 Safety Sample; n=number of participants with evaluation at time point||percent of total white blood cell count||Full Range|Median
710975|NCT00169442|Secondary|Seroprotection Rates for Anti-D Antibodies|The seroprotection rate is defined as the estimated proportion of subjects with protective antibodies as assessed by ELISA (antibody concentration ≥ 0.1 IU/mL), or by Vero-cell neutralisation assay (antibody concentration ≥ 0.016 IU/mL), for subjects seronegative as assessed by ELISA.|At Month 0, prior to the PRP challenge|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.||Proportion||95% Confidence Interval|Number
710976|NCT00169442|Secondary|Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ the Cut-off Value|The number of subjects with anti-D antibody concentrations equal to or above (≥) the cut-off value of 0.1 IU/mL as assessed by ELISA, (or ≥ 0.016 IU/mL as assessed by the neutralisation assay on Vero cells in subjects seronegative by ELISA testing) and, the number of subjects with anti-T antibody concentrations ≥ the cut-off value of 0.1 IU/mL as assessed by ELISA.|At Month 0, prior to the PRP challenge|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.||Participants|||Count of Participants
710977|NCT00169442|Secondary|Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL.|The number of subjects with anti-PRP antibody concentrations equal to or above (≥) 0.15 μg/mL and ≥ 1.0 μg/mL, prior to the booster vaccination.|At Month 0, prior to the PRP challenge|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.||Participants|||Count of Participants
710978|NCT00169442|Secondary|Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL|The number of subjects with anti-PRP antibody concentrations equal to or above (≥) 0.15 μg/mL and ≥ 1.0 μg/mL, prior to the PRP challenge.|At Month 0, prior to the PRP challenge|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.||Participants|||Count of Participants
710979|NCT00169442|Primary|Anti-BPT Antibody Concentrations|Anti-BPT antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL), as assessed by ELISA.|At Month 1, post-booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
710980|NCT00169442|Primary|Anti-HBs Antibody Concentrations|Anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL), as assessed by ELISA.|At Month 1, post-booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.||mIU/mL||95% Confidence Interval|Geometric Mean
710981|NCT00169442|Primary|Anti-D and Anti-T Antibody Concentrations|Anti-D and anti-T antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in International Units per milliliter (IU/mL), as assessed by ELISA.|At Month 1, post-booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.||IU/mL||95% Confidence Interval|Geometric Mean
710982|NCT00169442|Primary|Anti-PRP Antibody Concentrations.|Anti-PRP antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in microgram per milliliter (μg/mL), as assessed by ELISA.|At Month 1, post-booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.||μg/mL||95% Confidence Interval|Geometric Mean
710983|NCT00169442|Primary|Anti-PRP Antibody Concentrations|Anti-PRP antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in microgram per milliliter (μg/mL), as assessed by ELISA.|At Month 1, post-PRP challenge|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.||μg/mL||95% Confidence Interval|Geometric Mean
710984|NCT00169442|Primary|Number of Subjects With Booster Response to BPT Antigen|"The booster response was defined as:
an anti-BPT antibody concentration equal to or above (≥) the cut-off value (15 EL.U/mL) at post-booster vaccination in subjects seronegative (anti-BPT antibody concentration < 15 EL.U/mL) prior to administration of the booster dose; or
at least a 2-fold increase in antibody concentration from pre- to post-vaccination time points, in subjects who were seropositive (anti-BPT antibody concentration ≥ 15 EL.U/mL) prior to the administration of the booster dose."|At Month 1, post-booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.||Participants|||Count of Participants
710985|NCT00169442|Primary|Number of Seroprotected Subjects Against Bordetella Pertussis (BPT)|A seroprotected subject was defined as a vaccinated subject with an anti-BPT antibody concentration equal to or above (≥) 15 ELISA units per milliliter (EL.U/mL).|At Month 1, post-booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.||Participants|||Count of Participants
710986|NCT00169442|Primary|Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)|A seroprotected subject was defined as a vaccinated subject with an anti-HBs antibody concentration equal to or above (≥) 10 milli International Units per milliliter (mIU/mL).|At Month 1, post-booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.||Participants|||Count of Participants
710987|NCT00169442|Primary|Seroprotection Rates for Anti-D Antibodies|The seroprotection rate is defined as the estimated proportion of subjects with protective antibodies as assessed by the Enzyme-Linked Immunosorbent Assay (ELISA) (antibody concentration ≥ 0.1 IU/mL), or by Vero-cell neutralisation assay (antibody concentration ≥ 0.016 IU/mL), for subjects seronegative as assessed by ELISA.|At Month 1, post-booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.||Proportion||95% Confidence Interval|Number
711814|NCT00190684|Primary|Change From Baseline to 5 Year Endpoint in BP||baseline, 5 years|The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.||millimeters of Mercury (mmHg)||Standard Deviation|Mean
710989|NCT00169442|Primary|Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL.|The number of subjects with anti-PRP antibody concentrations equal to or above (≥) 0.15 μg/mL and ≥ 1.0 μg/mL, at one month post-booster vaccination.|At Month 1, post-booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.||Participants|||Count of Participants
710990|NCT00169442|Primary|Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL|The number of subjects with anti-PRP antibody concentrations equal to or above (≥) 0.15 μg/mL and ≥ 1.0 μg/mL, at one month after the PRP challenge.|At Month 1, post-PRP challenge|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.||Participants|||Count of Participants
710991|NCT00170157|Secondary|Percent of Participants With Undetectable Prostate-specific Antigen (PSA) Response|Percent of participants who had undetectable PSA at 3 months on the initially assigned treatment arm (prior to crossing over).|3 months|105 participants had follow-up PSA information; those without a follow-up PSA were excluded from this analysis.||percentage of participants|||Number
710992|NCT00170157|Primary|Number of Participants Progression-free at 18 Months|PSA progression is defined as a rise in PSA to >4.0 ng/mL demonstrated twice in measurements taken two weeks apart.|18 months from the start of AA therapy|||participants|||Number
710993|NCT00163189|Other Pre-specified|Fasting and Postprandial Plasma Glucose Levels at Month 12, 24, 36, 48 and 60|Fasting and 2 hours plasma glucose levels were assessed using standard oral glucose tolerance test (OGTT).|Screening, Month 12, 24, 36, 48, 60|Safety analysis set included all participants (including a site with GCP issues) who had received at least 1 study dose of GH.||milli mole per liter (mmol/L)||Standard Deviation|Mean
710994|NCT00163189|Other Pre-specified|Fasting Serum Insulin Like Growth Factor-1 (IGF-1) Levels||Screening, Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60|Safety analysis set included all participants (including a site with GCP issues) who had received at least 1 study dose of GH.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
710995|NCT00163189|Other Pre-specified|Number of Participants Who Received Concomitant Medications||Baseline up to Month 60|Safety analysis set included all participants (including a site with GCP issues) who had received at least 1 study dose of GH.||participants|||Number
710996|NCT00163189|Other Pre-specified|Number of Participants With at Least 1 Medical or Surgical History||Screening|Safety analysis set included all participants (including a site with GCP issues) who had received at least 1 study dose of GH.||participants|||Number
710997|NCT00163189|Other Pre-specified|Number of Participants With Significant Changes in Physical Examinations|Number of participants with clinically significant physical examinations changes since previous visit were reported. Physical examination including estimation of pubertal stage and blood pressure measurement;|Baseline, Month 12, 24, 36, 48, 60, End of Treatment (EOT)|Safety analysis set included all participants (including a site with GCP issues) who had received at least 1 study dose of GH.||participants|||Number
710998|NCT00163189|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs include both SAEs and non-SAEs.|Baseline up to 28 days after last study treatment|Safety analysis set included all participants (including a site with GCP issues) who had received at least 1 study dose of GH.||participants|||Number
710999|NCT00163189|Secondary|Ratio of Bone Age (BA) to Chronological Age (CA)|BA was estimated locally using an X-ray from the left wrist and hand. CA at the date of corresponding X-ray (Date of X-ray – Date of birth)/365.25. Ratio of BA/CA at each annual study visit was calculated.|Baseline, Month 12, 24, 36, 48, 60|"FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here n signifies those participants who were evaluable for the specified time point."||ratio||Standard Deviation|Mean
711000|NCT00163189|Secondary|Change From Baseline in Bone Age (BA) at Month 12, 24, 36, 48 and 60|BA was estimated locally using an X-ray from the left wrist and hand.|Baseline, Month 12, 24, 36, 48, 60|"FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here n signifies those participants who were evaluable for the specified time point."||months||Standard Deviation|Mean
711001|NCT00163189|Secondary|Change From Baseline in Height Standard Deviation Score (SDS) for Bone Age (BA) at Month 12, 24, 36, 48 and 60|The standing height measurements were performed using a wall mounted device (example Harpenden Stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded. Height SDS BA Yx = (height Yx – reference mean for BA Yx) / reference SD for BA Yx; Yx refers to the value at particular timepoint x. Height in SDS was calculated using Sempe reference means and SD for height. BA was estimated locally using an X-ray from the left wrist and hand.|Baseline, Month 12, 24, 36, 48, 60|"FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here n signifies those participants who were evaluable for the specified time point."||SDS||Standard Deviation|Mean
711002|NCT00163189|Secondary|Change From Baseline in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Month 12, 24, 48 and 60|The standing height measurements were performed using a wall mounted device (example Harpenden Stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded. Height SDS CA Yx = (height Yx – reference mean for CA Yx) / reference SD for CA Yx; Yx refers to the value at particular timepoint x. Height in SDS was calculated using Sempe reference means and SD for height. CA calculated as integer (Date of height measurement–Date of birth)/365.25*12.|Baseline, Month 12, 24, 48, 60|"FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here n signifies those participants who were evaluable for the specified time point."||SDS||Standard Deviation|Mean
711003|NCT00163189|Secondary|Change From Baseline in Height at Month 12, 24, 36, 48 and 60|The standing height measurements were performed using a wall mounted device (example Harpenden Stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded.|Baseline, Month 12, 24, 36, 48, 60|"FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here n signifies those participants who were evaluable for the specified time point."||cm||Standard Deviation|Mean
711004|NCT00163189|Secondary|Body Mass Index (BMI)|BMI was calculated by weight divided by height squared and measured as kilogram per square meter (kg/m^2).|Baseline, Month 12, 24, 36, 48, 60|"FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here n signifies those participants who were evaluable for the specified time point."||kg/m^2||Standard Deviation|Mean
711005|NCT00163189|Secondary|Growth Rate (GR) Standard Deviation Score (SDS) for Chronological Age (CA)|GR SDS CA Yx = (GR Yx – reference mean for CA Yx) / reference SD for CA Yx; Yx refers to the value at particular timepoint x. GR in SDS was calculated using Sempe reference means and SD for GR. CA calculated as integer (Date of height measurement–Date of birth)/365.25*12.|Baseline, Month 12, 24, 36, 48, 60|"FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here n signifies those participants who were evaluable for the specified time point."||SDS||Standard Deviation|Mean
711006|NCT00163189|Secondary|Growth Rate (GR) Standard Deviation Score (SDS) for Bone Age (BA)|GR SDS BA Yx = (GR Yx – reference mean for BA Yx) / reference SD for BA Yx; Yx refers to the value at particular timepoint x. GR in SDS was calculated using Sempe reference means and SD for GR. BA was estimated locally using an X-ray from the left wrist and hand.|Month 12, 24, 36, 48, 60|"FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here n signifies those participants who were evaluable for the specified time point."||SDS||Standard Deviation|Mean
711007|NCT00163189|Secondary|Annual Growth Rate (AGR)|AGR at Yx was derived by subtracting AGR at baseline from Yx value. AGR was calculated each year and re scaled to 1 year if the interval between Yx and Y[x-1] was not 365 days, as long as a participant remained in the study. AGR at Yx was calculated using the previous height measurements (Y[x-1]) and height recorded at Yx (AGR Yx = [height Yx–height Y{x-1}] / ([date of Yx – date of Y{x-1}] /365.25). Yx refers to the value at particular timepoint x.|Baseline, Month 12, 24, 36, 48, 60|"FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here n signifies those participants who were evaluable for the specified time point."||cm/year||Standard Deviation|Mean
711008|NCT00163189|Secondary|Mean Height Standard Deviation Score (SDS) for Bone Age (BA)|The standing height measurements were performed using a wall mounted device (example Harpenden Stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded. Height SDS BA Yx = (height Yx – reference mean for BA Yx) / reference SD for BA Yx; Yx refers to the value at particular timepoint x. Height in SDS was calculated using Sempe reference means and SD for height. BA was estimated locally using an X-ray from the left wrist and hand.|Baseline, Month 12, 24, 36, 48, 60|"FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here n signifies those participants who were evaluable for the specified time point."||SDS||Standard Deviation|Mean
711009|NCT00163189|Secondary|Mean Height|The standing height measurements were performed using a wall mounted device (example Harpenden Stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded.|Baseline, Month 12, 24, 36, 48, 60|"FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here n signifies those participants who were evaluable for the specified time point."||centimeters (cm)||Standard Deviation|Mean
711010|NCT00163189|Primary|Change From Baseline in Height Standard Deviation Score (SD) for Chronological Age (CA) at Month 36: Per Protocol (PP) Population|Height was measured using a wall mounted device (example, Harpenden stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded. Height SDS CA Yx = (height Yx – reference mean for CA Yx) / reference SD for CA Yx; Yx refers to the value at particular timepoint x. Height in SDS was calculated using Sempe reference means and SD for height. CA calculated as integer (Date of height measurement–Date of birth)/365.25*12.|Baseline, Month 36|"PP analysis set included all participants (excluding a site with GCP issues) who received at least 1 dose of GH, had at least 1 subsequent rating of height, no major protocol violation till first 3 years post initiation of treatment and total GH treatment duration of 36 months or more. n=participants evaluable at the specified time point."||SDS||Standard Deviation|Mean
711011|NCT00163189|Primary|Change From Baseline in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36: Full Analysis Population|Height was measured using a wall mounted device (example, Harpenden stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded. Height SDS CA Yx = (height Yx – reference mean for CA Yx) / reference SD for CA Yx; Yx refers to the value at particular timepoint x. Height in SDS was calculated using Sempe reference means and SD for height. CA calculated as integer (Date of height measurement–Date of birth)/365.25*12.|Baseline, Month 36|"Full analysis set (FAS) included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here n signifies those participants who were evaluable for the specified time point."||Standard Deviation Score (SDS)||Standard Deviation|Mean
711012|NCT00163215|Secondary|Ratio of Bone Age (BA) to Chronological Age (CA)|BA was estimated locally using an X-ray from the left wrist and hand. CA at the date of corresponding X-ray (Date of X-ray – Date of birth)/365.25. Ratio of BA/CA at each annual study visit was calculated.|Baseline, Month 12, Month 24, Month 36|ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and “n” signifies those participants evaluated at that time point.||ratio||Standard Deviation|Mean
711013|NCT00163215|Secondary|Change From Baseline in Bone Age (BA) at Month 12, Month 24 and Month 36|BA was estimated locally using an X-ray from the left wrist and hand.|Baseline, Month 12, Month 24, Month 36|ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and “n” signifies participants evaluated at that time point.||years||Standard Deviation|Mean
711014|NCT00163215|Secondary|Change From Baseline in Body Mass Index (BMI) at Month 12, Month 24 and Month 36|BMI was used to measure body fat based on height and weight. It was calculated as body weight (kilogram) divided by the height (meter) squared.|Baseline, Month 12, Month 24, Month 36|ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and “n” signifies participants evaluated at that time point.||kg/m^2||Standard Deviation|Mean
711015|NCT00163215|Secondary|Body Mass Index (BMI)|BMI was used to measure body fat based on height and weight. It was calculated as body weight (kilogram) divided by the height (meter) squared.|Baseline, Month 12, Month 24, Month 36|ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here “n” signifies those participants evaluated at that time point.||kilogram per square meter (kg/m^2)||Standard Deviation|Mean
711016|NCT00163215|Secondary|Mean Growth Rate Standard Deviation Score (SDS) for Bone Age (BA)|AGR at Yx was derived by subtracting AGR at baseline from Yx value. AGR was calculated each year and rescaled to 1 year if the interval between Yx and Y[x-1] was not 365 days, as long as a participant remained in the study. AGR at Yx = [height Yx–height Y{x-1}] / ([date of Yx – date of Y{x-1}] /365.25). GR in SDS was calculated using Sempe reference means and SD for growth. BA was estimated locally using an X-ray from the left wrist and hand. SDS indicates how similar the participant was to the reference population.|Month 12, Month 24, Month 36|ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and “n” signifies participants evaluated at that time point.||SDS||Standard Deviation|Mean
711017|NCT00163215|Secondary|Change From Baseline in Annual Growth Rate Standard Deviation Score (SDS) for Chronological Age (CA) at Month 12 and Month 24 in PP Population|Change in annual growth rate (AGR) standard deviation score (SDS) for chronological age (CA) derived by subtracting AGR SDS CA at baseline from each time point (Yx) value. AGR at Yx= (height Yx–height Y[x-1])/([date of Yx–date of Y{x-1}]/365.25). AGR as SDS calculated using Sempe reference means and standard deviations (SD) for growth rate. AGR SDS CA (for both baseline and Yx)= (AGR-reference mean for growth rate CA)/reference SD for growth rate CA. CA calculated as integer (Date of height measurement-Date of birth)/365.25*12. SDS indicates how similar participant was to reference population.|Baseline, Month 12, Month 24|PP analysis set included all participants in the ITT set without a major protocol violation. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure.||SDS||Standard Deviation|Mean
711018|NCT00163215|Secondary|Change From Baseline in Annual Growth Rate Standard Deviation Score (SDS) for Chronological Age (CA) at Month 12 and Month 24 in ITT Population|Change in AGR SDS for CA derived by subtracting AGR SDS CA at baseline from Yx value. AGR at Yx= (height Yx–height Y[x-1])/([date of Yx–date of Y{x-1}]/365.25). AGR as SDS calculated using Sempe reference means and standard deviations (SD) for growth rate. AGR SDS CA (for both baseline and Yx)= (AGR-reference mean for growth rate CA)/reference SD for growth rate CA. CA calculated as integer (Date of height measurement-Date of birth)/365.25*12. SDS indicates how similar participant was to reference population.|Baseline, Month 12, Month 24|ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure.||SDS||Standard Deviation|Mean
711019|NCT00163215|Secondary|Change From Baseline in Height Standard Deviation Score (SDS) for Bone Age (BA) at Month 12, Month 24 and Month 36|Change in height SDS BA was derived by subtracting height SDS BA at baseline from Yx value. Height SDS BA (for both baseline and Yx) = (height–reference mean for BA)/reference SD for BA. Height in SDS was calculated using Sempe reference means and SD for height. BA was estimated locally using an X-ray from the left wrist and hand. SDS indicates how similar the participant was to the reference population.|Baseline, Month 12, Month 24, Month 36|ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and “n” signifies participants evaluated at that time point.||SDS||Standard Deviation|Mean
711020|NCT00163215|Secondary|Mean Height Standard Deviation Score (SDS) for Bone Age (BA)|Height SDS BA Yx = (height Yx – reference mean for BA Yx) / reference SD for BA Yx. Height in SDS was calculated using Sempe reference means and SD for height. BA was estimated locally using an X-ray from the left wrist and hand. SDS indicates how similar the participant was to the reference population.|Baseline, Month 12, Month 24, Month 36|ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and “n” signifies participants evaluated at that time point.||SDS||Standard Deviation|Mean
711021|NCT00163215|Secondary|Change From Baseline in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Month 12, Month 24 and Month 36|Change in height SDS CA was derived by subtracting height SDS CA at baseline from Yx value. Height SDS CA (for both baseline and Yx) = (height – reference mean for CA)/reference SD for CA. Height in SDS was calculated using Sempe reference means and SD for height. CA calculated as integer (Date of height measurement – Date of birth)/365.25*12. SDS indicates how similar the participant was to the reference population.|Baseline, Month 12, Month 24, Month 36|ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and “n” signifies participants evaluated at that time point.||SDS||Standard Deviation|Mean
711022|NCT00163215|Secondary|Mean Height Standard Deviation Score (SDS) for Chronological Age (CA)|Height was measured using a wall mounted device (example, Harpenden stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded. Height SDS CA Yx = (height Yx – reference mean for CA Yx) / reference SD for CA Yx. Height in SDS was calculated using Sempe reference means and SD for height. CA calculated as integer (Date of height measurement–Date of birth)/365.25*12. SDS indicates how similar the participant was to the reference population.|Baseline, Month 12, Month 24, Month 36|ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here “n” signifies those participants evaluated at that time point.||SDS||Standard Deviation|Mean
711023|NCT00163215|Secondary|Change From Baseline in Height at Month 12, Month 24 and Month 36|Height was measured using a wall mounted device (example, Harpenden stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded.|Baseline, Month 12, Month 24, Month 36|ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and “n” signifies participants evaluated at that time point.||cm||Standard Deviation|Mean
711024|NCT00163215|Secondary|Height|Height was measured using a wall mounted device (example, Harpenden stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded.|Baseline, Month 12, Month 24, Month 36|"ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here n signifies those participants evaluated at that time point."||cm||Standard Deviation|Mean
711025|NCT00163215|Secondary|Change From Baseline in Annual Growth Rate at Month 12, Month 24, Month 36 in PP Population|Change in AGR at Yx was derived by subtracting AGR at baseline from Yx value. Annual growth rate was calculated each year and rescaled to 1 year if the interval between Yx and Y[x-1] was not 365 days, as long as a participant remained in the study. AGR at Yx was calculated using the previous height measurements (Y[x-1]) and height recorded at Yx (AGR Yx = [height Yx–height Y{x-1}] / ([date of Yx – date of Y{x-1}] /365.25).|Baseline, Month 12, Month 24, Month 36|PP analysis set included all participants in the ITT set without a major protocol violation. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and “n” signifies participants evaluated at that time point.||cm/year||Standard Deviation|Mean
711026|NCT00163215|Secondary|Change From Baseline in Annual Growth Rate at Month 12, Month 24 and Month 36 in ITT Population|Change in AGR at Yx was derived by subtracting AGR at baseline from Yx value. Annual growth rate was calculated each year and rescaled to 1 year if the interval between Yx and Y[x-1] was not 365 days, as long as a participant remained in the study. AGR at Yx was calculated using the previous height measurements (Y[x-1]) and height recorded at Yx (AGR Yx = [height Yx–height Y{x-1}] / ([date of Yx – date of Y{x-1}] /365.25).|Baseline, Month 12, Month 24, Month 36|ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and “n” signifies participants evaluated at that time point.||centimeter per year (cm/year)||Standard Deviation|Mean
711027|NCT00163215|Primary|Change From Baseline in Annual Growth Rate Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36 in Per-Protocol (PP) Population|Change in annual growth rate (AGR) standard deviation score (SDS) for chronological age (CA) derived by subtracting AGR SDS CA at baseline from each time point (Yx) value. AGR at Yx= (height Yx–height Y[x-1])/([date of Yx–date of Y{x-1}]/365.25). AGR as SDS calculated using Sempe reference means and standard deviations (SD) for growth rate. AGR SDS CA (for both baseline and Yx)= (AGR-reference mean for growth rate CA)/reference SD for growth rate CA. CA calculated as integer (Date of height measurement-Date of birth)/365.25*12. SDS indicates how similar participant was to reference population.|Baseline, Month 36|Per Protocol (PP) analysis set included all participants in the ITT set without a major protocol violation. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and “n” signifies participants evaluated at that time point.||SDS||Standard Deviation|Mean
711028|NCT00163215|Primary|Change From Baseline in Annual Growth Rate Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36 in Intent-to-Treat (ITT) Population|Change in annual growth rate (AGR) standard deviation score (SDS) for chronological age (CA) derived by subtracting AGR SDS CA at baseline from each time point (Yx) value. AGR at Yx= (height Yx–height Y[x-1])/([date of Yx–date of Y{x-1}]/365.25). AGR as SDS calculated using Sempe reference means and standard deviations (SD) for growth rate. AGR SDS CA (for both baseline and Yx)= (AGR-reference mean for growth rate CA)/reference SD for growth rate CA. CA calculated as integer (Date of height measurement-Date of birth)/365.25*12. SDS indicates how similar participant was to reference population.|Baseline, Month 36|Intent to Treat (ITT) set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and “n” signifies participants evaluated at that time point.||SDS||Standard Deviation|Mean
711052|NCT00171704|Secondary|Time to Overall Survival Events|Overall survival was measured from date of randomization to date of death.|60 Months|All randomized patients constituted the ITT Population, unless withdrawal of consent occurred after randomization but before the start of study treatment assigned.||days||Inter-Quartile Range|Median
711053|NCT00171704|Secondary|Time to Disease Recurrence or Death|Disease-free survival was defined as the interval between randomization and earliest confirmed event of loco-regional recurrence, distant metastases, invasive contralateral breast cancer, or death from any cause.|60 months|Analysis of disease-free survival was based on the ITT principle, with all enrolled (and randomized) patients included. The Kaplan-Meier product-limit approach was used.||Days||Inter-Quartile Range|Median
711054|NCT00171704|Secondary|Number of Participants With Clinically Relevant Changes From Baseline in Cholesterol|Serum lipid profile (fasting serum cholesterol [total, HDL and calculated LDL], triglycerides, and lipoprotein [a]) were measured at baseline/screening and at each visit thereafter. A central laboratory was used to analyze the samples. Numbers are not additive, as patients could be included in multiple rows.|Baseline, 60 months|The safety population consisted of only patients who took randomized therapy for at least one day. The number of patients with pre-defined clinically relevant changes in serum lipids over the course of 5 years in each treatment arm is presented.||Participants|||Number
711055|NCT00171704|Secondary|Percentage Change From Baseline in Serum Lipids at 5 Years|Serum lipid profile (fasting serum cholesterol [total, HDL and calculated LDL], triglycerides, and lipoprotein [a]) were measured at baseline/screening and at each visit thereafter. A central laboratory was used to analyze the samples. The analysis of serum lipids was on the treatment group median percent change from baseline (and range) at 5 years.|Baseline, 60 months|The safety population consisted of only patients who took randomized therapy for at least one day. During different time points, participants with observations at that time point were included in the analysis.||Percent Change||Full Range|Median
711056|NCT00171704|Secondary|Median Percent Change From Baseline of Serum Markers of Bone Turnover|Bone turnover markers (fasting serum procollagen-I extension peptide [P1NP], C-telopeptide [CTX], skeletal bone-specific alkaline phosphatase [BSAP, N-telopeptide [NTX]) were measured at baseline/screening and at each visit thereafter. A central laboratory was used to analyze the samples. The analysis of bone markers was based on analysis of variance of the regression slopes calculated for each individual patient and each bone marker over time. In the following summary, only the median treatment group percent change from baseline (and range) at 5 years is presented for each bone marker.|Baseline, 60 months|The safety population consisted of only patients who took randomized therapy for at least one day. During different time points, participants with observations at that time point were included in the analysis. The analysis of bone markers over time consisted of patients with measurements of specific markers at each time point.||Percent Change||Full Range|Median
711057|NCT00171704|Secondary|Percent Change From Baseline of Bone Mineral Density (BMD) of Total Hip|Total hip BMD measurements by dual energy X-ray absorptiometry (DXA) were performed after surgery and within 2 weeks prior to randomization and repeated every 6 months for the first 2 years and annually thereafter until 5 years after enrollment. All DXA scans were evaluated by a central reader.|Baseline, 60 months|The safety population consisted of only patients who took randomized therapy for at least one day. The analysis of BMD at 5 years included all patients enrolled with centrally assessed measurements of total hip BMD.||Percent Change||Full Range|Median
711058|NCT00171704|Secondary|Percent Change From Baseline of Bone Mineral Density of the Lumbar Spine|Lumbar spine (L2-L4)BMD measurements by dual energy X-ray absorptiometry (DXA) were performed after surgery and within 2 weeks prior to randomization and repeated every 6 months for the first 2 years and annually thereafter until 5 years after enrollment. The primary scanning site was the lumbar spine (L2 to L4) and the secondary scanning site was the total hip. All DXA scans were evaluated by a central reader.|Baseline, 60 months|The safety population consisted of only patients who took randomized therapy for at least one day. The analysis at 5 years included all patients enrolled and who had centrally assessed measurements of lumbar spine and/or total hip BMD.||Percent change||Full Range|Median
711059|NCT00171704|Primary|Percent Change From Baseline of Bone Mineral Density of the Lumbar Spine (L2-l4)|Lumbar spine (L2-L4) BMD measurements by dual energy X-ray absorptiometry (DXA) were performed after surgery and within 2 weeks prior to randomization and repeated every 6 months for the first 2 years and annually thereafter until 5 years after enrollment. The primary scanning site was the lumbar spine (L2 to L4) and the secondary scanning site was the total hip. All DXA scans were evaluated by a central reader.|Baseline, 24 months|The safety population consisted of only patients who took randomized therapy for at least one day. The number of patients in each treatment arm who had completed 2 years of the study and had centrally assessed measurements of lumbar spine or total hip BMD.||Percent Change||Full Range|Median
711060|NCT00171834|Secondary|Duration of Overall Response -Phase I and Phase II|Duration of overall response (CR or PR) measured by RECIST was measured from the first documented CR or PR to the date of first documented disease progression or discontinuation due to disease progression, or death from underlying cancer, whichever event occured first.|Duration of response according to RECIST from start of study until study discontinuation. Duration of response was assessed every second cycle ( i.e. approximately every 6 weeks) until disease progression or discontinuation from study. Average 18 weeks|Full Analysis Set (FAS) consisted of all patients who received at least one dose of patupilone. Analysis of the primary and all secondary efficacy endpoints was performed based on this population. According to the Intention to Treat (ITT) principle, patients were analyzed based on the treatment to which they were assigned at study entry.||Months||95% Confidence Interval|Median
711061|NCT00171834|Secondary|Time to Overall Response -Phase I and Phase II|Time to overall response (CR or PR) measured by RECIST was the time between study start until date of first documented response (CR or PR).|From baseline, then every second cycle (i.e. approximately every 6 weeks), until disease progression or discontinuation from study. Average 18 weeks|Full Analysis Set (FAS) consisted of all patients who received at least one dose of patupilone. Analysis of the primary and all secondary efficacy endpoints was performed based on this population. According to the Intention to Treat (ITT) principle, patients were analyzed based on the treatment to which they were assigned at study entry.||Months||95% Confidence Interval|Median
711062|NCT00171834|Secondary|Duration of Stable Disease-Phase I and Phase II|Duration of stable disease (CR, PR, or SD) by RECIST was defined as the time from start of study drug to the date of first documented disease progression or discontinuation due to disease progression, or death from underlying cancer, whichever event occured first.|Imaging was assessed every second cycle (i.e. approximately every 6 weeks), until disease progression or discontinuation from treatment . Average 18 weeks|Full Analysis Set (FAS) consisted of all patients who received at least one dose of patupilone. Analysis of the primary and all secondary efficacy endpoints was performed based on this population. According to the Intention to Treat (ITT) principle, patients were analyzed based on the treatment to which they were assigned at study entry.||Months||95% Confidence Interval|Median
711075|NCT00171925|Secondary|Number of Patients With Progression by Individual Criteria|Number of patients with progression by individual criteria consisting of Progression of disease overall, Skeletal-related events (including pathological fracture, initiation of radiotherapy or surgery on bone, spinal cord compression or Hypercalcemia), Progression to stage II or III according to Salmon & Durie classification, and unequivocal progression of osteolytic lesion. Patients are counted separately for every type of progression, but only once for Overall Progression.|48 months|Intent to Treat Population||Participants|||Number
711113|NCT00167206|Primary|Number of Patients Who Exhibited Hematopoietic Recovery and Engraftment|Calculated from Day 1 of hematopoietic cell transplant to Day 42 post-transplant. Hematopoietic recovery and engraftment is defined as the first of three consecutive days the patient's absolute neutrophil count is greater than or equal to 0.5X10^9/Liter.|Day 42 after hematopoietic cell transplant|||Participants|||Number
711063|NCT00171834|Primary|Phase II: Number of Participants With Best Overall Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST)|Overall response is the number of participants who had a complete response (CR) or a partial response (PR) based on local investigator’s assessment of RECIST criteria. Per RECIST: CR, all detectable tumor has disappeared; PR, a >=30% decrease in the sum of the longest dimensions of the target lesions (TLs) taking as a reference the baseline sum, no worsening of non-TLs, and no new lesions; Progressive disease (PD), a >=20% increase in TLs, clearly worsening of non-TLs, or emergence of new lesions; Stable Disease (SD), small changes that do not meet previously given criteria.|At baseline, then every second cycle (approximately every 6 weeks), until disease progression or discontinuation. Average 18 weeks.|Full Analysis Set (FAS) consisted of all patients who received at least one dose of patupilone. Analysis of the primary and all secondary efficacy endpoints was performed based on this population. According to the Intention to Treat (ITT) principle, patients were analyzed based on the treatment to which they were assigned at study entry.||Participants|||Number
711064|NCT00171834|Primary|Phase I: Number of Total Dose-limiting Toxicity (DLT) During Dose Escalation to Determine Maximum Tolerated Dose (MTD)|The MTD was defined as the highest dose of patupilone administered every three weeks (q3w) where not more than one out of six patients experienced a DLT using a standard 3+3 design. Dose escalation started at 6.5 mg/m^2 until MTD in steps of 0.5 mg/m^2 until 12 mg/m^2, then in steps of 1 mg/m^2 till 13.0 mg/m^2. DLTs were assessed during cycle 1. During this time frame, no more than one DLT occurred in any of the explored dose levels up to 13 mg/m^2, thus, the MTD as defined by the protocol was not reached in this study.|Cycle 1 (21 days)|Maximum tolerated dose (MTD) determining population.included all patients who completed the first treatment cycle (Cycle 1) according to protocol or discontinued due to a DLT. The first cycle data from this patient population were used to determine the MTD in the Phase I part of the study.||Dose Limiting Toxicity (DLT)|||Number
711065|NCT00171834|Secondary|Time to Progression (TTP)-Phase I and Phase II|Time to progression was measured from the start of study drug to the date of first documented disease progression by RECIST, discontinuation due to disease progression, or death from underlying cancer, whichever event occurred first. If a patient had not progressed by RECIST, discontinued due to disease progression, or died from underlying cancer, TTP was censored at the time of last adequate tumor assessment. However, if a patient took any new cancer therapy prior to PD or death, then TTP was censored at the date of last adequate tumor assessment prior to the start date of new cancer therapy.|From baseline, then every second cycle (i.e. approximately every 6 weeks), until disease progression or discontinuation from study. Average 18 weeks|Full Analysis Set (FAS) consisted of all patients who received at least one dose of patupilone. Analysis of the primary and all secondary efficacy endpoints was performed based on this population. According to the Intention to Treat (ITT) principle, patients were analyzed based on the treatment to which they were assigned at study entry.||Months||95% Confidence Interval|Median
711066|NCT00171834|Secondary|Overall Survival Time-Phase I and Phase II|Overall survival (OS) time was measured from the start of study drug to the date of death due to any cause. If a patient was not known to have died, survival was censored at the date of last contact. Data was collected post treatment every 3 months until approximately 70% of patients have reached the survival endpoint (Phase I + Phase II).|From start of study drug to date of death due to any cause. Follow-up after treatment discontinuation approximately every 3 months until approximately 70% of participants have reached the survival endpoint. Average 9.75 months|Full Analysis Set (FAS) consisted of all patients who received at least one dose of patupilone. Analysis of the primary and all secondary efficacy endpoints was performed based on this population. According to the Intention to Treat (ITT) principle, patients were analyzed based on the treatment to which they were assigned at study entry.||Months||95% Confidence Interval|Median
711067|NCT00171834|Secondary|Number of Participants With Best Overall Response-Phase I|This was defined as the number of participants whose best overall response was CR or PR by RECIST. Per RECIST: CR, all detectable tumor has disappeared; PR, a >=30% decrease in the sum of the longest dimensions of the target lesions (TLs) taking as a reference the baseline sum, no worsening of non-TLs, and no new lesions; Progressive disease (PD), a >=20% increase in TLs, clearly worsening of non-TLs, or emergence of new lesions; Stable Disease (SD), small changes that do not meet previously given criteria.|Best achieved overall response according to RECIST from start of study until study discontinuation. Imaging was assessed every second cycle (ie. approximately every 6 weeks) until disease progression or discontinuation. Average 18 weeks|Full Analysis Set (FAS) consisted of all patients who received at least one dose of patupilone. Analysis of the primary and all secondary efficacy endpoints was performed based on this population. According to the Intention to Treat (ITT) principle, patients were analyzed based on the treatment to which they were assigned at study entry.||Participants|||Number
711068|NCT00171873|Secondary|Survival||at least on a monthly basis||12/2014||||
711069|NCT00171873|Secondary|Quality of Life (Standardized Questionnaire) at Three-month Intervals in Comparison With the Start of the Study||at three-month intervals||12/2014||||
711070|NCT00171873|Secondary|Symptom Control at 3 Month Intervals||at 3 month intervals up to 18 moths||12/2014||||
711071|NCT00171873|Secondary|Biochemical Response at 3 Month Intervals||at 3 month intervals up to 18 moths||12/2014||||
711072|NCT00171873|Secondary|Objective Response Rates According to World Health Organization (WHO) Criteria at 3 Month Intervals||at 3 month intervals||12/2014||||
711073|NCT00171873|Primary|Time to Tumor Progression Documented by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)|Median time to tumor progression at the time of the planned interim analysis that includes all data observed until June 2008.|Up to 7 years|Conservative Intent to Treat (ITT) population consisting of all participants who received study drug. 3 participants in the Octreotide group and 1 participant in the placebo group without liver involvement at the beginning of the study were excluded from this analysis.||Months||95% Confidence Interval|Median
711074|NCT00171925|Secondary|The Number of Participants With the Development of Skeletal Complications|"Pathologic fracture: bone fractures that occur spontaneously or from trivial trauma. New vertebral compression fracture defined as a decrease in vertebral height of 25% from baseline
Spinal cord compression: the impingement of tumor on the spinal cord confirmed by radiography
Bone Radiotherapy: Bone irradiation to palliate painful lesions, treat or prevent pathologic fractures or spinal cord compression
Surgery on bone: surgical procedures performed to set, stabilize or prevent pathologic fractures or areas of spinal cord compression
Hypercalcemia: Corrected serum calcium ≥ 12.0 mg/dl"|48 months|Intent to treat population||Participants|||Number
711076|NCT00171925|Primary|Days of Progression Free Survival|"Progression-free survival was defined as time from date of randomization to death from any cause or one of the following events:
progression to stage II or III according to Salmon & Durie classification
skeletal related events (pathologic fracture, initiation of radiotherapy or surgery on bone, spinal cord compression or hypercalcemia)
unequivocal progression of osteolytic lesions (at least a 20% increase in the largest diameter of one existing osteolytic lesion which is measured in at least one dimension as 20 mm with conventional techniques), determined radiologically."|48 months|Intent to Treat Population||Days||Standard Error|Mean
711077|NCT00172042|Primary|Percentage of Participants With Progression-Free Survival Events|Percentage of Participants with the Progression-free survival events: disease progression and death. Time to disease progression (TTP) was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines with evaluations every 3 months.|Up to 24 months|Intent-to-Treat Population consisting of all randomized participants.||Percentage of participants|||Number
711078|NCT00172042|Primary|Kaplan-Meier Estimates for Progression-free Survival|Progression-free survival is defined as the time from randomization to the date of the first documented progression or recurrence of disease or death from any cause. Time to disease progression (TTP) was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines with evaluations every 3 months.|Months 6, 12, 18, and 24|Intent-to-Treat Population consisting of all randomized participants.||Percentage of participants||95% Confidence Interval|Number
711079|NCT00172042|Secondary|Kaplan-Meier Estimates for Overall Survival||Months 6, 12, 18, and 24|Intent-to-Treat Population consisting of all randomized participants.||Percentage of participants||95% Confidence Interval|Number
711080|NCT00172042|Secondary|Kaplan-Meier Estimates of the Time to the First Skeletal Related Event (SRE)|Time to the first skeletal related event defined as the time from randomization to the date of occurrence of the first SRE. Skeletal Related Events were defined as radiation therapy or surgery to bone, spinal cord compression event or a pathologic bone fracture event|Months 6,12, 18, and 24|Intent-to-Treat Population consisting of all randomized participants. Any participant in whom no SRE had been observed during the study was to be censored at the date of the last visit or the date of death whichever was the earlier.||Percentage of participants||95% Confidence Interval|Number
711081|NCT00172042|Secondary|Percentage of Participants With Skeletal Related Events (SREs) at 12 and 24 Months From Study Entry|Skeletal Related Events were defined as radiation therapy or surgery to bone, spinal cord compression event or a pathologic bone fracture event.|Months 12 and 24|Intent-to-Treat Population consisting of all randomized participants.||Percentage of participants|||Number
711082|NCT00172042|Secondary|Kaplan-Meier Estimate of the Time to Occurrence of Bone Metastases|Time to occurrence of bone metastases was defined as the time from randomization to the date of the first documented bone metastases which could be asymptomatic or symptomatic at the time of detection. Bone scans were scheduled at screening and at 6-monthly intervals after study entry, or when symptoms suggested the presence of bone metastases. Positive bone scans required confirmation by x-ray, magnetic resonance imaging (MRI), or computed tomography (CT).|Months 6, 12, 18, and 24|Intent-to-Treat Population consisting of all randomized participants. Any participant without documented bone metastases at the date of analysis was to be censored at the date of the last bone scan.||Percentage of participants||95% Confidence Interval|Number
711083|NCT00172042|Secondary|Percentage of Participants With Bone Metastases at 6, 12, 18, and 24 Months|Percentage of participants developing at least 1 bone metastasis, whether or not symptomatic. Bone scans were scheduled at screening and at 6-monthly intervals after study entry, or when symptoms suggested the presence of bone metastases. Positive bone scans required confirmation by x-ray, magnetic resonance imaging (MRI), or computed tomography (CT).|Months 6, 12, 18 and 24|Intent-to-Treat Population consisting of all randomized participants.||Percentage of participants|||Number
711084|NCT00172042|Primary|Progression-Free Survival|Progression-free survival is defined as the time from randomization to the date of the first documented progression or recurrence of disease or death from any cause. Time to disease progression (TTP) was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines with evaluations every 3 months.|Up to 24 months|Intent-to-Treat Population consisting of all randomized participants.||Months||95% Confidence Interval|Median
711085|NCT00172185|Secondary|Number of Subjects Who Achieved at Least a One-Day Reduction in Parenteral Nutrition (PN) Use|Number of Subjects Who Achieved at Least a One-Day Reduction in Parenteral Nutrition (PN) Use (Responder Status is Yes or No)|6 months|Response Status is Yes or No||participants|||Number
711086|NCT00172185|Primary|Number of Subjects Achieving a 20% Reduction at Week 28|"For those subjects who received teduglutide (0.05 or 0.10 mg dose) in Study 004 and the same in Study 005, Parenteral Nutrition (PN) Use at Week 28 was compared to the Baseline Visit of Study 004 to calculate the 20% reduction in PN Use.
For those subjects who received placebo in Study 004 and either teduglutide 0.05 or 0.10 mg dose in Study 005, PN Use at Week 28 was compared to the use of PN at Week 24 of Study 004 to calculate the 20% reduction in PN Use."|28 weeks|Number of participants for analysis was determined based on completing all of the prerequisite visits in Study 005. Subjects who dropped out of the study were considered failures.||Participants|||Number
711087|NCT00166361|Primary|Mean Stent Dwell Time|Stent dwell time is defined as the amount of time a stent can remain in the body after it placed, before it needs to be removed due to failure.|baseline to 59 months after placement of stent|||months||Full Range|Mean
711088|NCT00166504|Primary|LDL-C Lowering Efficacy|LDL-C = low density lipoprotein cholesterol, measured in mg/dl.|6 weeks|Included patients with LDL-C data at both baseline and at the 6-week post-randomization time point.||Percent Change from Baseline||Standard Deviation|Least Squares Mean
711089|NCT00166517|Secondary|Serum Neutralizing Antibody (SNA) Response to Serotypes G1, G2, G3, G4 and P1A|"Number of subjects with ≥ 3-fold rise from baseline (Predose 1) in
SNA response to G1, G2, G3, G4 and P1A 14 days Postdose 3"|Baseline and 14 days Postdose 3|Per Protocol Population||Participants|||Number
711090|NCT00166517|Primary|Serum Anti-Rotavirus IgA Response|"Number of subjects with ≥ 3-fold rise from baseline (Predose 1) in
Serum IgA 14 days Postdose 3"|Baseline and 14 days Postdose 3|Per Protocol Population||Participants|||Number
711091|NCT00166712|Secondary|Patient and Graft Survival Rates at 6 and 12 Months Post-transplant||At 6 & 12 months post-transplant|Study was stopped due to efficacy and no data was collected for this outcome measure.|||||
711114|NCT00167245|Secondary|The Penn Alcohol Craving Scale and the Minnesota Cocaine Craving Scale During the Medication Treatment Phase, Compared to Placebo-treated Subjects.||13 weeks||||||
711092|NCT00166712|Secondary|Incidence of Donor Specific Hyporesponsiveness Allowing for the Conversion to Monotherapy|The proportion of subjects for both groups determine this measure: 1) Patients in tacrolimus arm who do not experience acute rejection and demonstrate evidence of donor specific hyporesonsiveness at 9 months post-transplant (those staying on TAC+MMF) or 3 months post-convertion (converted from TAC+MMF to Sirolimus+MMF) will be weaned to MMF monotherapy; 2) Those in the sirolimus+MMF arm who do not experience acute rejection and demonstrate evidence of donor specific hyporesponsiveness at 6 months post-transplant will be weaned to MMF monotherapy.|At 6 & 9 months post-transplant|Study was stopped due to efficacy and no data was collected for this outcome measure.|||||
711093|NCT00166712|Secondary|Renal Function at 12 Months Post-transplant|Laboratory tests for renal function include creatinine or iothalamate glomerular filtration rate (GFR).|At 12 months post-transplant|Study was stopped due to efficacy and no data was collected for this outcome measure.|||||
711094|NCT00166712|Secondary|Severity of Acute Rejection During the First 6 and 12 Months Post-transplant|The diagnosis of rejection will be based on clinical symptoms and signs, laboratory tests, and confirmed by core renal allograft biopsy.|Months 6-12 post-transplant|Study was terminated due to efficacy and there is no data was collected for this outcome measure.|||||
711095|NCT00166712|Primary|The Incidence of Biopsy-proven Acute Allograft Rejection During the First 12 Months of Transplant.|The incidence of rejection is determined by the proportion of patients experiencing biopsy proven acute allograft rejection during the first 12 months post-transplant.|Within 12 months post kidney transplant|33 total subjects reached the 12 month participation mark.||Participants|||Number
711096|NCT00167102|Primary|Number of Adverse Events|Number of any adverse event reported throughout the study, regardless of relation to study drug|24 weeks|||adverse events|||Number
711097|NCT00167102|Secondary|To Qualitatively Assess the Subjects Perception of Their Scalp Disease With Treatment, and Upon Withdrawal of Treatment, in Relation to Baseline.||12 weeks||||||
711098|NCT00167102|Secondary|In Those Who Respond to Treatment, the Durability of the Response Will be Assessed Over a 12-week Post-treatment Period of Observation.||12 weeks||||||
711099|NCT00167102|Primary|The Proportion of Subjects Achieving at Least a 50% Reduction in Their Scalp Alopecia Areata Severity Scores (SALT Score) From Baseline Values|Assess the therapeutic efficacy of a 12-week regimen of weekly IM administration of alefacept followed by a 12 week observation period in subjects with chronic severe scalp alopecia|24 weeks|||percentage of participants|||Number
711100|NCT00167180|Secondary|Number of Patients With Bone Marrow Aplasia|"Aplastic anemia is a disorder in which the bone marrow greatly decreases or stops production of blood cells.
In aplastic anemia, the basic structure of the marrow becomes abnormal, and those cells responsible for generating blood cells (hematopoietic cells) are greatly decreased in number or absent. These hematopoietic cells are replaced by large quantities of fat."|Day 100|||Participants|||Count of Participants
711101|NCT00167180|Secondary|Number of Patients With Acute Graft-Versus-Host Disease|Acute Graft-Versus-Host Disease is a severe short-term complication created by infusion of donor cells into a foreign host.|Day 100|||Participants|||Count of Participants
711102|NCT00167180|Secondary|Number of Participants With Complete Remission|In complete remission, all signs and symptoms of cancer that can be detected with modern technology have disappeared, although cancer still may be in the body.|one year|||Participants|||Count of Participants
711103|NCT00167180|Secondary|Number of Patients Alive Without Disease|The number of patients alive one year after treatment without any signs or symptoms of the cancer being treated or any other type of cancer. In a clinical trial, measuring the disease-free survival is one way to see how well a new treatment works.|1 Year|||Participants|||Count of Participants
711104|NCT00167180|Primary|Number of Patients Alive|"The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. Also called survival rate.
Overall survival will be defined as time from date of enrollment to date of death or censored at the date of last documented contact for patients still alive."|1 Year|||Participants|||Count of Participants
711105|NCT00167206|Secondary|Number of Patients Alive at 2 Years|Calculated from Day 1 of hematopoietic cell transplant to 2 years post-transplant.|2 years after transplant|||Participants|||Number
711106|NCT00167206|Secondary|Number of Patients Alive at 1 Year|Calculated from Day 1 of hematopoietic cell transplant to 1 year post-transplant.|1 year after transplant|||Participants|||Number
711107|NCT00167206|Secondary|Immune Reconstitution - Mean Value (2 Years)|Calculated mean value of patient CD4 values collected at intervals from Day 30 through 2 years post-transplant.|at 2 years after transplant|||Number of CD4 cells per microliter||Standard Deviation|Mean
711108|NCT00167206|Secondary|Immune Reconstitution - Mean Value (1 Year)|Calculated mean value of patient CD4 values collected at intervals from Day 30 through 1 year post-transplant.|1 year post-transplant.|||Number of CD4 cells per microliter||Standard Deviation|Mean
711109|NCT00167206|Secondary|Number of Patients Who Exhibited Regimen-related Toxicity (RRT)|Calculated from Day 1 of hematopoietic cell transplant to 1 year after transplant. Regimen-related toxicity involves harmful effects in an organism through exposure to the treatment given.|1 year after hematopoietic cell transplant|||Participants|||Number
711110|NCT00167206|Secondary|Number of Patients With Chronic Graft Versus-Host Disease (GVHD)|"Calculated from Day 1 of hematopoietic cell transplant to 1 year after transplant. GVHD is a common complication of allogeneic bone marrow transplantation in which functional immune cells in the transplanted marrow recognize the recipient as foreign and mount an immunologic attack."|1 year after hematopoietic cell transplant|||Participants|||Number
711111|NCT00167206|Secondary|Number of Patients With Acute Graft Versus-Host Disease (aGVHD)|"Calculated from Day 1 of hematopoietic cell transplant to Day 100 after transplant. GVHD is a common complication of allogeneic bone marrow transplantation in which functional immune cells in the transplanted marrow recognize the recipient as foreign and mount an immunologic attack."|Day 100 after hematopoietic cell transplant|||Participants|||Number
711112|NCT00167206|Secondary|Number of Patients Who Exhibited Secondary Graft Failure|Calculated from Day 1 of hematopoietic cell transplant to Day 100 after transplant. A complication after Bone Marrow Transplant in which the transplanted stem cells do not grow in the recipient’s bone marrow and thus do not produce new blood cells.|Day 100 after hematopoietic cell transplant|||Participants|||Number
711119|NCT00167245|Primary|Percent of Participants Abstinent From Cocaine During Last 3 Weeks of 13 Week Trial|Samples were analyzed for benzoylecgonine by fluorescent polarization assay. Samples containing equal to or greater than 300 ng/ml of benzoylecgonine were considered to be positive for cocaine.|Last 3 weeks of 13 week trial|||Percent of participants|||Number
711120|NCT00167310|Secondary|Plasma Cholesterol Levels in Various Lipoprotein Fractions|Biochemical Measures: Plasma levels of total cholesterol, LDL-cholesterol, HDL-cholesterol, VLDL-cholesterol, Lp(a) cholesterol, IDL-cholesterol, HDL3-cholesterol, VLDL1,2-cholesterol, and VLDL3-cholesterol.|4 months|||mg/dL||Standard Deviation|Mean
711121|NCT00167310|Primary|Plasma Levels of Triglycerides and Lipoprotein Cholesterol|Biochemical measures: Plasma levels of triglycerides, small dense LDL (LDL3- and LDL4-) cholesterol, large buoyant LDL (LDL1- and LDL2-) cholesterol, and HDL2-cholesterol.|4 months|Plasma triglyceride levels||mg/dL||Standard Deviation|Mean
711122|NCT00167388|Primary|Change in Superior Mesenteric Artery Blood Flow Velocity From Pre-to-post Feed in the Anemic and the Transfused States|Time-averaged mean and Peak systolic Doppler blood flow velocity in the mesenteric artery was measured before and after a feed when the baby was anemic (pre-PRBC transfusion) and then again when the baby was immediately post-transfusion|1 hour|the number below represents the change in the parameter with feeding while the baby anemic (pre-transfusion)||cm/sec||Standard Deviation|Mean
711123|NCT00167544|Secondary|Survival Without Severe Bronchopulmonary Dysplasia (BPD)|Using the NIH Consensus definition (Jobe A, 2001)|36 weeks postmenstrual age|||participants|||Number
711124|NCT00167544|Secondary|Duration of Oxygen Requirement||Up to 36 weeks PMA|||days||95% Confidence Interval|Mean
711125|NCT00167544|Secondary|Duration of Positive Pressure Support (Mechanical Ventilation or Continuous Positive Airway Pressure)||Up to 36 weeks PMA|||days||95% Confidence Interval|Mean
711126|NCT00167544|Secondary|Regional Brain Volumes|Cerebral white matter volume|38-weeks postmenstrual age|In addition to the reasons cited for the primary outcome, one infant in the hydrocortisone group and two in the placebo group had artifacts on brain MRI precluding cerebral white matter segmentation and volume determination.||cm^3||Standard Deviation|Mean
711127|NCT00167544|Primary|Total Cerebral Volume as Measured by Volumetric Brain MRI|Total cerebral volume included all brain gray matter and white matter, including cerebellum.|38 weeks postmenstrual age (PMA)|Eight infants died in each group prior to term MRI precluding a determination of brain volumes. Additionally, four infants had poor quality MRI scans that could not be analyzed for brain volumes.||cm^3||Standard Deviation|Mean
711128|NCT00174187|Other Pre-specified|Insulin-like Growth Factor-1 (IGF-1) Concentration After Year 3||Year 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10; 0.5 and 1 year after somatropin discontinuation, Final Height (assessed up to Year 11)|FAS After year 3: included all participants who received at least 1 dose of the study treatment and who had at least 1 post-baseline height measurement. Here, 'n' signifies those participants who were evaluable for this measure at given time point.||milligram per deciliter (mg/dL)||Full Range|Median
711129|NCT00174187|Other Pre-specified|Insulin-like Growth Factor-1 (IGF-1) Concentration up to Year 3||Baseline, Year 1, 2, 3|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.||nanogram per milliliter (ng/mL)||Full Range|Median
711130|NCT00174187|Other Pre-specified|Growth Velocity Standard Deviation Score According to Bone Age (GV [SDS/BA])|GV measures the annual rate of increase in height. GV (SDS/BA) was obtained by measuring GV, subtracting the bone age- and gender-appropriate mean GV and dividing the result by standard deviation of that mean (as obtained from bone age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant’s value was relative to the mean of the reference population.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.||SDS||Inter-Quartile Range|Median
711131|NCT00174187|Other Pre-specified|Growth Velocity Standard Deviation Score According to Chronological Age (GV [SDS/CA])|GV measures the annual rate of increase in height. GV (SDS/CA) was obtained by measuring GV, subtracting the chronological age- and gender-appropriate mean GV and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant’s value was relative to the mean of the reference population.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.||SDS||Inter-Quartile Range|Median
711132|NCT00174187|Other Pre-specified|Growth Velocity (GV)|Growth velocity measures the annual rate of increase in height.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.||cm/year||Inter-Quartile Range|Median
711133|NCT00174187|Secondary|Bone Mineral Content Standard Deviation Score of Total Body According to Tanner Puberty Stage (BMC [TB] [SDS/Tanner Puberty Stage])|BMC (TB) was measured by DEXA scan. BMC (TB) (SDS/Tanner Puberty Stage) was obtained by measuring BMC (TB), subtracting the Tanner puberty stage- and gender-appropriate mean BMC (TB) and dividing the result by standard deviation of that mean (as obtained from Tanner puberty stage- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant’s value was relative to the mean of the reference population.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.||SDS||Inter-Quartile Range|Median
717778|NCT00282672|Secondary|Histological Clearance of IM (% Biopsies)|% of patients with histological clearance of IM out of the number of participants analyzed at 12 month was calculated.|12 months|||percentage of participants|||Number
711134|NCT00174187|Secondary|Bone Mineral Content Standard Deviation Score of Total Body According to Chronological Age (BMC [TB] [SDS/CA])|BMC (TB) was measured by DEXA scan. BMC (TB) (SDS/CA) was obtained by measuring BMC (TB), subtracting the chronological age- and gender-appropriate mean BMC (TB) and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant’s value was relative to the mean of the reference population.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.||SDS||Inter-Quartile Range|Median
711135|NCT00174187|Secondary|Percent Change From Baseline in Bone Mineral Content of Total Body (BMC [TB]) at Year 3|BMC is an estimate of the amount of mineral (such as calcium) in the bone. Percent change: (BMC [TB] at Year 3 minus BMC [TB] at baseline) divided by BMC [TB] at baseline, multiplied by 100.|Baseline, Year 3|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||percent change||Inter-Quartile Range|Median
711136|NCT00174187|Secondary|Annual Percent Change in Bone Mineral Content of Total Body (BMC [TB]) at Year 1, 2 and 3|BMC is an estimate of the amount of mineral (such as calcium) in the bone. Annual percent change: (BMC [TB] at current year minus BMC [TB] at previous year) divided by BMC [TB] at previous year, multiplied by 100.|Baseline, Year 1, 2, 3|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.||percent change||Inter-Quartile Range|Median
711137|NCT00174187|Secondary|Bone Mineral Content of Total Body (BMC [TB])|DEXA scan of BMC was used to evaluate potential bone effects of treatment. BMC is an estimate of the amount of mineral (such as calcium) in the bone.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.||gram||Inter-Quartile Range|Median
711138|NCT00174187|Secondary|Bone Mineral Density of Lumbar Spine (BMD [LS])|BMD (LS) was assessed by DEXA scan.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.||g/cm^2||Inter-Quartile Range|Median
711139|NCT00174187|Secondary|Bone Mineral Density of Total Body (BMD [TB])|BMD (TB) was assessed by DEXA scan.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.||gram per square centimeter (g/cm^2)||Inter-Quartile Range|Median
711140|NCT00174187|Secondary|Apparent Bone Mineral Density Standard Deviation Score of Lumber Spine According to Tanner Puberty Stage (BMAD [LS] [SDS/Tanner Puberty Stage])|BMAD (LS) was assessed by DEXA scan. BMAD (LS) (SDS/Tanner Puberty Stage) was obtained by measuring BMAD (LS), subtracting Tanner puberty stage- and gender-appropriate mean BMAD (LS) and dividing the result by standard deviation of that mean (as obtained from Tanner puberty stage- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant’s value was relative to the mean of the reference population.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.||SDS||Inter-Quartile Range|Median
711141|NCT00174187|Secondary|Apparent Bone Mineral Density Standard Deviation Score of Lumbar Spine According to Chronological Age (BMAD [LS] [SDS/CA])|BMAD (LS) was assessed by DEXA scan. BMAD (LS) (SDS/CA) was obtained by measuring the BMAD (LS), subtracting chronological age- and gender-appropriate mean BMAD (LS) and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant’s value was relative to the mean of the reference population.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.||SDS||Inter-Quartile Range|Median
711142|NCT00174187|Secondary|Apparent Bone Mineral Density of Lumbar Spine (BMAD [LS])|BMAD (LS) was assessed by DEXA scan.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.||gram per cubic centimeter (g/cm^3)||Inter-Quartile Range|Median
711143|NCT00174187|Secondary|Fat Mass Standard Deviation Score According to Chronological Age (SDS/CA)|Fat mass was assessed by DEXA scan. Fat mass SDS/CA was obtained by measuring fat mass, subtracting chronological age- and gender-appropriate mean fat mass and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant’s value was relative to the mean of the reference population.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.||SDS||Inter-Quartile Range|Median
712230|NCT00194792|Primary|Quantification of All Grade 2, 3, 4 Adverse Events or Fatal Toxicities|Count of all incidences of grade 2, 3, 4 adverse events and fatal toxicities|Monthly during neoadjuvant treatment and then 6 months following treatment (including surgery)|||events|||Number
711144|NCT00174187|Secondary|Fat Mass as Percentage of Total Weight|Fat mass, a measurement of body composition, was assessed by DEXA scan.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.||percentage of total weight||Inter-Quartile Range|Median
711145|NCT00174187|Secondary|Percent Change From Baseline in Fat Mass at Year 3|Fat mass, a measurement of body composition, was assessed by DEXA scan. Percent change: (Fat mass at Year 3 minus fat mass at baseline) divided by fat mass at baseline, multiplied by 100.|Baseline, Year 3|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||percent change||Inter-Quartile Range|Median
711146|NCT00174187|Secondary|Annual Percent Change in Fat Mass at Year 1, 2 and 3|Fat mass, a measurement of body composition, was assessed by DEXA scan. Annual percent change: (Fat mass at current year minus fat mass at previous year) divided by fat mass at previous year, multiplied by 100.|Baseline, Year 1, 2, 3|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.||percent change||Inter-Quartile Range|Median
711147|NCT00174187|Secondary|Fat Mass|Fat mass, a measurement of body composition, was assessed by DEXA scan.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.||kg||Inter-Quartile Range|Median
711148|NCT00174187|Secondary|Lean Body Mass Standard Deviation Score According to Chronological Age (SDS/CA)|Lean body mass was assessed by DEXA scan. Lean body mass SDS/CA was obtained by measuring lean body mass, subtracting the chronological age- and gender-appropriate mean lean body mass and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant’s value was relative to the mean of the reference population.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.||SDS||Inter-Quartile Range|Median
711149|NCT00174187|Secondary|Lean Body Mass as Percentage of Total Weight|Lean body mass, a measurement of body composition, was assessed by DEXA scan.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.||percentage of total weight||Inter-Quartile Range|Median
711150|NCT00174187|Secondary|Percent Change From Baseline in Lean Body Mass at Year 3|Lean body mass, a measurement of body composition, was assessed by DEXA scan. Percent change: (Lean body mass at Year 3 minus lean body mass at baseline) divided by lean body mass at baseline, multiplied by 100.|Baseline, Year 3|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||percent change||Inter-Quartile Range|Median
711151|NCT00174187|Secondary|Annual Percent Change in Lean Body Mass at Year 1, 2 and 3|Lean body mass, a measurement of body composition, was assessed by DEXA scan. Annual percent change: (Lean body mass at current year minus lean body mass at previous year) divided by lean body mass at previous year, multiplied by 100.|Baseline, Year 1, 2, 3|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.||percent change||Inter-Quartile Range|Median
711152|NCT00174187|Secondary|Lean Body Mass|Lean body mass, a measurement of body composition, was assessed by Dual Energy X-ray Absorptiometry (DEXA) scan.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.||kilogram (kg)||Inter-Quartile Range|Median
711153|NCT00174187|Secondary|Bone Age|Bone age was determined by the Greulich and Pyle method using left wrist and hand X-ray.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.||years||Inter-Quartile Range|Median
711154|NCT00174187|Primary|Puberty Stage at Final Height|Pubertal stage (graded from I to V for breast development and pubic hair development) according to the Tanner's method was collected. A low stage (Stage I) corresponds to a pre-pubertal stage and a high stage (Stage V) to an adult stage.|When final height was reached (assessed up to Year 11)|FAS- after Year 3: included all participants who received at least one dose of study treatment and who had at least one post-baseline height measurement. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants who were evaluable for given components of puberty assessment.||participants|||Number
711155|NCT00174187|Primary|Change From Baseline in Weight Standard Deviation Score (SDS) at Final Height|Body weight was measured using a balance scale. Weight SDS was obtained by measuring the weight, subtracting age- and gender-appropriate mean weight and dividing the result by standard deviation of that mean (as obtained from age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant’s value was relative to the mean of the reference population.|Baseline, when final height was reached (assessed up to Year 11)|FAS- after Year 3: included all participants who received at least one dose of the study treatment and who had at least one post-baseline height measurement. Here, 'n' signifies those participants who were evaluable for this measure at given time point.||SDS||Full Range|Median
711156|NCT00174187|Primary|Change From Baseline in Height Standard Deviation Score According to Chronological Age (SDS/CA) at Final Height|Height was measured using a wall mounted device (example, Harpenden stadiometer). Height SDS/CA was obtained by measuring the height, subtracting chronological age- and gender-appropriate mean height and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant’s value was relative to the mean of the reference population.|Baseline, when final height was reached (assessed up to Year 11)|FAS- after Year 3: included all participants who received at least 1 dose of the study treatment and who had at least 1 post-baseline height measurement. Here, 'n' signifies those participants who were evaluable for this measure at given time points.||SDS||Full Range|Median
711157|NCT00174187|Primary|Change From Baseline in Height Standard Deviation Score According to Chronological Age (SDS/CA) at Year 3|Height was measured using a wall mounted device (example, Harpenden stadiometer). Height SDS/CA was obtained by measuring the height, subtracting chronological age- and gender-appropriate mean height and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant’s value was relative to the mean of the reference population.|Baseline, Year 3|Full Analysis Set (FAS) up to Year 3: included all participants who had at least 1 post-baseline height measurement and were treated with the study drug for at least 1 year.||Standard Deviation Score (SDS)||Inter-Quartile Range|Median
711158|NCT00174252|Secondary|IGF-1/IGFBP-3 Ratio at 12 and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months||12 and 24 months|SAS. Number of Participants Analyzed = Number of children with IGF-1 > 2 SD at 9 and 12 months with evaluable IGF-1/IGFBP-3 data at 12 and 24 months.||ratio||Standard Deviation|Mean
711159|NCT00174252|Secondary|IGF-1/Insulin-Like Growth Factor Binding Protein 3 (IGFBP-3) Ratio at 12 and 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months||12 and 24 months|SAS. Number of Participants Analyzed = Number of children treated. n = Number of children with IGF-1 < = 2 SD at 9 or 12 months with evaluable IGF-1/IGFBP-3 data at 12 and 24 months.||ratio||Standard Deviation|Mean
711160|NCT00174252|Secondary|Summary of IGF-1 SD at 6, 9, 12, 15, 18, 21, and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months|IGF-1 SD was calculated at each study time point using these gender specific IGF-1 reference means and SDs for the CA of the child on the date of the corresponding IGF-1 blood sample: IGF-1 SD = (IGF-1 – reference mean) / reference SD|6, 9, 12, 15, 18, 21, and 24 months|SAS. Number of Participants Analyzed = Number of children treated. n = Number of children with IGF-1 > 2 SD at 9 and 12 months with evaluable IGF-1 SD data at 6, 9, 12, 15, 18, 21, and 24 months.||SD||Standard Deviation|Mean
711161|NCT00174252|Secondary|Summary of IGF-1 SD at 6, 9, 12, 15, 18, 21, and 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months|IGF-1 SD was calculated at each study time point using gender specific IGF-1 reference mean and SD for the CA of the child on the date of the corresponding IGF-1 blood sample: IGF-1 SD = (IGF-1 minus reference mean) divided by reference SD|6, 9, 12, 15, 18, 21, and 24 months|SAS. Number of Participants Analyzed = Number of children treated. n = Number of children with IGF-1 < = 2 SD at 9 or 12 months with evaluable IGF-1 SD data at 6, 9, 12, 15, 18, 21, and 24 months.||SD||Standard Deviation|Mean
711162|NCT00174252|Other Pre-specified|BA/CA at 12 and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months|The BA/CA ratio was calculated at Screening, 12 and 24 months. The CA was the age on the date that the corresponding BA X-ray was performed.|12 and 24 months|FAS. Number of Participants Analyzed = Number of children with IGF-1 > 2 SD at 9 and 12 months with evaluable BA/CA data at 12 and 24 months.||ratio||Standard Deviation|Mean
711163|NCT00174252|Other Pre-specified|BA/CA at 12 and 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months|The BA/CA ratio was calculated at Screening, 12 and 24 months. The CA was the age on the date that the corresponding BA X-ray was performed.|12 and 24 months|FAS. Number of Participants Analyzed = Number of children with IGF-1 < = 2 SD at 9 or 12 months with evaluable BA/CA data at 12 and 24 months.||ratio||Standard Deviation|Mean
711164|NCT00174252|Other Pre-specified|Change in BA From Baseline at 12 and 24 Months|Change in BA was calculated as: (12 or 24 months minus Screening)|Baseline, 12 and 24 months|FAS. Number of Participants Analyzed = Number of children treated. n = Number of children with evaluable BA data at 12 and 24 months.||year||Standard Deviation|Mean
711165|NCT00174252|Secondary|ANCOVA for Height SD BA at 24 Months in Children With IGF-1 <= 2 SD at 9 or 12 Months and IGF-1 > 2 SD at 9 and 12 Months|Height SD (BA) at 24 months|Baseline, 24 months|FAS. Number of Participants Analyzed = Number of children with IGF-1 < = 2 SD at 9 or 12 months or with IGF-1 > 2 SD at 9 and 12 months and with evaluable height SD BA data at 24 months.||SD for BA||Standard Error|Mean
711166|NCT00174252|Secondary|ANCOVA for Height SD BA at 12 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months and IGF-1 > 2 SD at 9 and 12 Months|"Change in Height SD (BA) was calculated as:
Height SD (BA) at 12 months minus Height SD (BA) at Baseline"|Baseline, 12 months|FAS. Number of Participants Analyzed = Number of children with IGF-1 < = 2 SD at 9 or 12 months or with IGF-1 > 2 SD at 9 and 12 months and with evaluable height SD BA data at 12 months.||SD for BA||Standard Error|Mean
711167|NCT00174252|Secondary|ANCOVA for Height SD CA at 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months and IGF-1 > 2 SD at 9 and 12 Months|Height SD (CA) at 24 months.|Baseline, 24 months|FAS. Number of Participants Analyzed = Number of children with IGF-1 < = 2 SD at 9 or 12 months or with IGF-1 > 2 SD at 9 and 12 months and with evaluable height SD CA data at 24 months.||SD for CA||Standard Error|Mean
711168|NCT00174252|Secondary|Analysis of Covariance (ANCOVA) for Height SD CA at 12 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months and IGF-1 > 2 SD at 9 and 12 Months|"Change in Height SD (CA) was calculated as:
Height SD (CA) at 12 months minus Height SD (CA) at Baseline"|Baseline, 12 months|FAS. Number of Participants Analyzed = Number of children with IGF-1 < = 2 SD at 9 or 12 months or with IGF-1 > 2 SD at 9 and 12 months and with evaluable height SD CA data at 12 months.||SD for CA||Standard Error|Mean
711169|NCT00174252|Other Pre-specified|Summary of Body Mass Index (BMI) at 12 and 24 Months|BMI was calculated at 12 months and 24 months as: (Weight at 12 or 24 months divided by Height at 12 or 24 months) squared|12 and 24 months|FAS. Number of Participants Analyzed = Number of children treated. n = Number of children with evaluable BMI data at 12 and 24 months.||kg/meters squared (m2)||Standard Deviation|Mean
711170|NCT00174252|Secondary|Summary of Growth Rate SD (BA) at 12 and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months|"Growth rate SD BA at 12 months was calculated as: (Growth rate at 12 months minus reference mean for BA at 12 months) divided by reference SD for CA at 12 months
Growth rate SD BA at 24 months was calculated as: (Growth rate at 24 months minus reference mean for BA at 24 months) divided by reference SD for CA at 24 months"|12 and 24 months|FAS. Number of Participants Analyzed = Number of children with IGF-1 > 2 SD at 9 and 12 months with evaluable growth rate SD BA data at 12 months. n = Number of children with IGF-1 > 2 SD at 9 and 12 months with evaluable growth rate SD BA data at 24 months.||SD for BA||Standard Deviation|Mean
711171|NCT00174252|Secondary|Summary of Growth Rate SD (BA) at 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months|Growth rate SD BA at 24 months was calculated as: (Growth rate at 24 months minus reference mean for BA at 24 months) divided by reference SD for BA at 24 months|Baseline, 24 months|FAS. Number of Participants Analyzed = Number of children with IGF-1 < = 2 SD at 9 or 12 months with evaluable growth rate SD BA data at 24 months.||SD for BA||Standard Deviation|Mean
711172|NCT00174252|Secondary|Summary of Growth Rate SD (BA) at 12 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months|Growth rate SD BA at 12 months was calculated as: (Growth rate at 12 months minus reference mean for BA at 12 months) divided by reference SD for BA at 12 months|Baseline, 12 months|FAS. Number of Participants Analyzed = Number of children with IGF-1 < = 2 SD at 9 or 12 months with evaluable growth rate SD BA data at 12 months.||SD for CA||Standard Deviation|Mean
711173|NCT00174252|Secondary|Summary of Growth Rate SD (CA) at 12 and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months|"Growth rate SD CA at 12 months was calculated as: (Growth rate at 12 months minus reference mean for CA at 12 months) divided by reference SD for CA at 12 months
Growth rate SD CA at 24 months was calculated as: (Growth rate at 24 months minus reference mean for CA at 24 months) divided by reference SD for CA at 24 months"|12 and 24 months|FAS. Number of Participants Analyzed = Number of children with IGF-1 > 2 SD at 9 and 12 months with evaluable growth rate SD CA data at 12 and 24 months.||SD for CA||Standard Deviation|Mean
711174|NCT00174252|Secondary|Summary of Growth Rate SD (CA) at 12 and 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months|"Growth rate SD CA at 12 months was calculated as:(Growth rate at 12 months minus reference mean for CA at 12 months) divided by reference SD for CA at 12 months
Growth rate SD CA at 24 months was calculated as:(Growth rate at 24 months minus reference mean for CA at 24 months) divided by reference SD for CA at 24 months"|12 and 24 months|FAS. Number of Participants Analyzed = Number of children with IGF-1 < = 2 SD at 9 or 12 months with evaluable growth rate SD CA data at 12 months. n = Number of children with IGF-1 < = 2 SD at 9 or 12 months with evaluable growth rate SD CA data at 24 months.||SD for CA||Standard Deviation|Mean
711175|NCT00174252|Other Pre-specified|Growth Rate at 12 and 24 Months|"Growth Rate was calculated at 12 months as:
(Height at 12 months minus Height at Day 0) divided by {(Date of 12 months minus Date of Day 0) divided by 365.25}
Growth Rate was calculated at 24 months as:
(Height at 24 months minus Height at 12 months) divided by {(Date of 24 months minus Date of 12 months) divided by 365.25}"|12 and 24 months|FAS. Number of Participants Analyzed = Number of children treated. n = Number of children with evaluable growth rate data at 12 and 24 months.||cm/year||Standard Deviation|Mean
711176|NCT00174252|Secondary|Change in Height SD BA From Baseline at 12 and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months|"The height in SD was calculated using Sempe reference means and SDs for height. Change in height SD was calculated as height in SD at “12 or 24 months” minus height in SD at “Baseline."|Baseline, 12 and 24 months|FAS. Number of Participants Analyzed = Number of children with IGF-1 > 2 SD at 9 or 12 months with evaluable height SD BA data at 12 and 12 months.||SD for BA||Standard Deviation|Mean
711177|NCT00174252|Secondary|Change in Height SD BA From Baseline at 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months|"The height in SD was calculated using Sempe reference means and SDs for height. Change in height SD was calculated as height in SD at “24 months” minus height in SD at “Baseline."|Baseline, 24 months|FAS. Number of Participants Analyzed = Number of children with IGF-1 < = 2 SD at 9 or 12 months with evaluable height SD BA data at 24 months.||Height in SD||Standard Deviation|Mean
711178|NCT00174252|Secondary|Change in Height SD Bone Age (BA) From Baseline at 12 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months|"The height in SD was calculated using Sempe reference means and SDs for height. Change in height SD was calculated as height in SD at “12 months” minus height in SD at Baseline."|Baseline, 12 months|FAS. Number of Participants Analyzed = Number of children with IGF-1 < = 2 SD at 9 or 12 months with evaluable height SD BA data at 12 months.||SD for BA||Standard Deviation|Mean
711179|NCT00174252|Secondary|Change in Height SD CA From Baseline at 12 and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months|"The height in SD was calculated using Sempe reference means and SDs for height. Change in height SD was calculated as height in SD at “12 or 24 months” minus height in SD at “Baseline."|Baseline, 12 and 24 months|FAS. Number of Participants Analyzed = Number of children with IGF-1 > 2 SD at 9 and 12 months with evaluable Height SD CA data at 12 and 24 months.||SD for BA||Standard Deviation|Mean
711180|NCT00174252|Secondary|Change in Height SD CA From Baseline at 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months|"The height in SD was calculated using Sempe reference means and SDs for height. Change in height SD was calculated as height in SD at “24 months” minus height in SD at Baseline."|Baseline, 24 months|FAS. Number of Participants Analyzed = Number of children with IGF-1 < = 2 SD at 9 or 12 months with evaluable height SD CA data at 24 months.||SD for CA||Standard Deviation|Mean
711181|NCT00174252|Secondary|Change in Height SD Chronological Age (CA) From Baseline at 12 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months|"The height in SD was calculated using Sempe reference means and standard deviations for height. Change in height SD was calculated as height in SD at 12 months” minus height in SD at Baseline."|Baseline, 12 months|The full analysis set (FAS) included all patients who received at least one dose of assigned treatment and had at least one subsequent rating of IGF-1. Number of Participants Analyzed = Number of children with IGF-1 < = 2 SD at 9 or 12 months with evaluable height SD CA data at 12 months.||SD for CA||Standard Deviation|Mean
711182|NCT00174252|Primary|Percentage of Children With Insulin Growth Factor-1 (IGF-1) > 2 Standard Deviation (SD) at 9 and 12 Months|Percentage of children with serum IGF-1 > 2 SD (compared to a child of the same gender and age and without growth hormone (GH) deficiency) 9 months and 12 months after initiation of GH treatment. 9 months and 12 months are combined.|9 and 12 months|The safety analysis set (SAS) was defined as all patients who received at least one dose of GH treatment. Number of Participants Analyzed = Number of children treated.||percentage of participants|||Number
711183|NCT00174252|Other Pre-specified|Change in Height From Baseline|The standing height measurements were performed at the same time of the day by using a wallmounted device (e.g. Harpenden Stadiometer) at each study visit. The pre-specified clinical outcomes were analyzed at 12 and 24 months.|Baseline, 12 and 24 months|FAS. Number of Participants Analyzed = Number of children with evaluable height data at 12 and 24 months.||centimeters (cm)||Standard Deviation|Mean
711184|NCT00174265|Secondary|Change From Baseline in Quality of Life Measured by the Quality of Life Scale (QLS) Total Score|The QLS is a 21-item clinician-rated scale for rating psychosocial functioning (Interpersonal Relations, Instrumental Role, Intrapsychic Foundations, and Common Objects and Activities). The score ranges from 0 (worst) to 126 (best), with greater values indicating better quality of life.|Baseline of A7501013 to Day 365|ITT population. In-treatment change from baseline scores by visit and baseline scores from the ITT population are included in the MMRM model.||Units on a Scale||Standard Error|Least Squares Mean
711185|NCT00174265|Primary|Change From Baseline in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale Total Score|The NSA Scale is a 16-item clinician-rated instrument for rating the negative symptomatology of schizophrenia. Total score ranges from 16 (best) to 96 (worst), with greater scores indicating greater severity of symptoms.|Baseline of A7501013 to Day 365|Intent-to-treat (ITT) population. In-treatment change from baseline scores by visit and baseline scores from the ITT population are included in the Mixed Model for Repeated Measurements (MMRM) model.||Units on a Scale||Standard Error|Least Squares Mean
711186|NCT00174291|Secondary|Change From Baseline in Corticosteroid Dose at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9||Baseline, Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9|FAS included all participants who received at least 1 dose of study treatment and had at least 1 post-baseline height measurement. Here, 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.||mg||Full Range|Median
711187|NCT00174291|Secondary|Change From Baseline in Weight Standard Deviation Score (SDS) at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9|Body weight was measured using a balance scale. Weight SDS was obtained by measuring the weight, subtracting age- and gender- appropriate mean weight and dividing the result by standard deviation of that mean (as obtained from age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant’s value was relative to the mean of the reference population.|Baseline, Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9|FAS included all participants who received at least 1 dose of study treatment and had at least 1 post-baseline height measurement. Here, 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.||SDS||Full Range|Median
711188|NCT00174291|Secondary|Change From Baseline in Bone Mineralization at Year 1, 2, 3, 4, 5, 6, 7, 8 and 9|Bone mineralization, an estimate of the amount of mineral (such as calcium) in the bone, was assessed using DEXA scan.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9|FAS included all participants who received at least 1 dose of study treatment and had at least 1 post-baseline height measurement. Here, 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.||grams||Full Range|Median
711189|NCT00174291|Secondary|Change From Baseline in Lean Mass and Fat Mass at Year 1, 2, 3, 4, 5, 6, 7, 8 and 9|Lean mass and fat mass: measurements of body composition assessed using Dual Energy X-ray Absorptiometry (DEXA) scan.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9|Data were collected and reported in individual participant listing but not statistically summarized due to early termination of the study.|||||
711190|NCT00174291|Secondary|Change From Baseline in Insulin-like Growth Factor Binding Protein 3 (IGFBP3) Concentration at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9||Baseline, Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9|Data were collected and reported in individual participant listing but not statistically summarized due to early termination of the study.|||||
711191|NCT00174291|Secondary|Change From Baseline in Insulin-like Growth Factor-1 (IGF-1) Concentration at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9||Baseline, Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9|FAS included all participants who received at least 1 dose of study treatment and had at least 1 post-baseline height measurement. Here, 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.||milligram per deciliter (mg/dL)||Full Range|Median
711192|NCT00174291|Primary|Change From Baseline in Predicted Height Standard Deviation Score (SDS) at Final Height|Predicted height was calculated according to Greulich and Pyle using Bayley Pinneau method. Predicted height SDS was obtained by calculating the predicted height, subtracting chronological age- and gender-appropriate mean predicted height and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant’s value was relative to the mean of the reference population.|Baseline, final height (assessed up to Year 9.5)|FAS included all participants who received at least 1 dose of study treatment and had at least 1 post-baseline height measurement. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure.||SDS||Full Range|Median
711193|NCT00174291|Primary|Change From Baseline in Predicted Height Standard Deviation Score (SDS) at Year 3|Predicted height was calculated according to Greulich and Pyle using Bayley Pinneau method. Predicted height SDS was obtained by calculating the predicted height, subtracting chronological age- and gender-appropriate mean predicted height and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant’s value was relative to the mean of the reference population.|Baseline, Year 3|FAS included all participants who received at least 1 dose of study treatment and had at least 1 post-baseline height measurement. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure.||SDS||Full Range|Median
711243|NCT00176462|Primary|Percentage of Patients With ALL at High Risk of Relapse (Arm 2) Who Were Relapse-free at 5 Years|This measure looks at the percentage of patients on Arm 2 who did not experience a relapse at 5 years, where relapse is defined as the presence of progressive disease after the achievement of a complete remission.|5 years|Number of high risk ALL patients treated.||percentage of participants|||Number
711194|NCT00174291|Primary|Change From Baseline in Height Standard Deviation Score (SDS) at Final Height|Height was measured using a wall mounted device (example, Harpenden stadiometer). Height SDS was obtained by measuring the height, subtracting chronological age- and gender-appropriate mean height and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant’s value was relative to the mean of the reference population.|Baseline, final height (assessed up to Year 9.5)|FAS included all participants who received at least 1 dose of study treatment and had at least 1 post-baseline height measurement. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure.||SDS||Full Range|Median
711195|NCT00174291|Primary|Change From Baseline in Height Standard Deviation Score (SDS) at Year 3|Height was measured using a wall mounted device (example, Harpenden stadiometer). Height SDS was obtained by measuring the height, subtracting chronological age- and gender-appropriate mean height and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant’s value was relative to the mean of the reference population.|Baseline, Year 3|FAS included all participants who received at least 1 dose of study treatment and had at least 1 post-baseline height measurement. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure.||SDS||Full Range|Median
711196|NCT00174291|Primary|Change From Baseline in Annual Rate of Growth Standard Deviation Score (SDS) at Final Height|Annual rate of growth SDS was obtained by measuring the annual growth rate, subtracting chronological age- and gender-appropriate mean annual growth rate and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant’s value was relative to the mean of the reference population.|Baseline, final height (assessed up to Year 9.5)|Data was not analyzed because of change in planned analysis after early termination of the study.|||||
711197|NCT00174291|Primary|Change From Baseline in Annual Rate of Growth Standard Deviation Score (SDS) at Year 3|Annual rate of growth SDS was obtained by measuring the annual growth rate, subtracting chronological age- and gender-appropriate mean annual growth rate and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant’s value was relative to the mean of the reference population.|Baseline, Year 3|Full Analysis Set (FAS) included all participants who received at least 1 dose of study treatment and had at least 1 post-baseline height measurement. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure.||SDS||Full Range|Median
711198|NCT00175877|Secondary|Change From Baseline to Completion/Withdrawal Visit in Short-Form Health Survey (SF-36) Item Questionnaire Mental Component Summary (MCS) Score|The SF-36 is a 36-item generic health status measure that measures 8 general health concepts: Physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each domain of the eight domains and the summary concept MCS score are scored to yield values between 0 (worst) and 100 (best).|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)|Of the 846 subjects in the Safety Set (SS), 777 are included in this analysis. Data not available for 69 subjects.||units on a scale||Standard Deviation|Mean
711199|NCT00175877|Secondary|Change From Baseline to Completion/Withdrawal Visit in Short-Form Health Survey (SF-36) Item Questionnaire Physical Component Summary (PCS) Score|The SF-36 is a 36-item generic health status measure that measures 8 general health concepts: Physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each domain of the eight domains and the summary concept PCS score are scored to yield values between 0 (worst) and 100 (best).|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)|Of the 846 subjects in the Safety Set (SS), 777 are included in this analysis. Data not available for 69 subjects.||units on a scale||Standard Deviation|Mean
711200|NCT00175877|Secondary|Percentage of Subjects With Good European League Against Rheumatism (EULAR) Response at Completion/Withdrawal Visit|Good EULAR response is defined as Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28[ESR]) improvement from Baseline of the preceding double-blind study > 1.2 and DAS28[ESR] value < 3.2.|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)|Of the 846 subjects in the Safety Set (SS), 834 are included in this analysis. Data not available for 12 subjects.||percentage of participants|||Number
711201|NCT00175877|Secondary|Change From Baseline to Completion/Withdrawal Visit in Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28[ESR])|DAS28[ESR] is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity. A negative value in DAS28[ESR] change from Baseline indicates an improvement from Baseline.|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)|Of the 846 subjects in the Safety Set (SS), 834 are included in this analysis. Data not available for 12 subjects.||units on a scale||Standard Deviation|Mean
711202|NCT00175877|Secondary|Change From Baseline to Completion/Withdrawal Visit in Duration of Morning Stiffness|Morning stiffness is defined as the time in hours elapsed between the time of usual awakening (even if not in the morning) and the time the subject is as limber as he/she will be during a day involving typical activities. A negative value in duration of morning stiffness change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)|Of the 846 subjects in the Safety Set (SS), 838 are included in this analysis. Data not available for 8 subjects.||hours||Standard Deviation|Mean
711244|NCT00176488|Secondary|Correlate Tumor Response With Changes in the Gene Expression of Microtubule Associated Protein 4 (MAP4).||10 years|Study was closed prematurely and insufficient data was collected.|||||
711203|NCT00175877|Secondary|Change From Baseline of the Preceding Double-Blind Study to Completion/Withdrawal Visit in Health Assessment Questionnaire – Disability Index (HAQ-DI) Total Score|The HAQ-DI assesses the degree of difficulty experienced in eight domains (Dressing and Grooming, Arising, Eating, Walking, Hygiene, Reach, Gripping, Other Activities) of daily living activities using 20 questions. The HAQ-DI is calculated by summing the domain scores and dividing them by the number of domains. It ranges from 0 (no difficulty) to 3 (unable to do). Negative values indicate an improvement from Baseline to the Post-Baseline Visit with larger negative values showing a better improvement.|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)|Of the 846 subjects in the Safety Set (SS), 824 are included in this analysis. Data not available for 22 subjects.||units on a scale||Standard Deviation|Mean
711204|NCT00175877|Secondary|Change From Baseline of the Preceding Double-Blind Study to Week 96 in Modified Total Sharp Score (mTSS)|The mTSS quantifies the extent of bone erosions and joint space narrowing for 44 and 42 joints, respectively, as assessed by x-rays of the hands and feet. The score ranges from 0 to 448 with higher scores representing greater damage. A negative value in mTSS change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|From Baseline of the preceding double-blind study to Week 96 of the open-label study|Of the 846 subjects in the Safety Set (SS), 661 are included in this analysis. Data not available for 185 subjects.||units on a scale||Standard Deviation|Mean
711205|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Completion/Withdrawal|The assessments are based on a 70 % or greater improvement from Baseline to Completion/Withdrawal in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)|Of the 846 subjects in the Safety Set (SS), 841 are included in this analysis. Data not available for 5 subjects.||percentage of participants||95% Confidence Interval|Number
711206|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 240|The assessments are based on a 70 % or greater improvement from Baseline to Week 240 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 240 of the open-label study|Of the 846 subjects in the Safety Set (SS), 183 are included in this analysis. Data not available for 663 subjects.||percentage of participants||95% Confidence Interval|Number
711207|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 192|The assessments are based on a 70 % or greater improvement from Baseline to Week 192 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 192 of the open-label study|Of the 846 subjects in the Safety Set (SS), 537 are included in this analysis. Data not available for 309 subjects.||percentage of participants||95% Confidence Interval|Number
711208|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 144|The assessments are based on a 70 % or greater improvement from Baseline to Week 144 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 144 of the open-label study|Of the 846 subjects in the Safety Set (SS), 602 are included in this analysis. Data not available for 244 subjects.||percentage of participants||95% Confidence Interval|Number
711209|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 96|The assessments are based on a 70 % or greater improvement from Baseline to Week 96 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 96 of the open-label study|Of the 846 subjects in the Safety Set (SS), 668 are included in this analysis. Data not available for 178 subjects.||percentage of participants||95% Confidence Interval|Number
711210|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 48|The assessments are based on a 70 % or greater improvement from Baseline to Week 48 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 48 of the open-label study|Of the 846 subjects in the Safety Set (SS), 733 are included in this analysis. Data not available for 113 subjects.||percentage of participants||95% Confidence Interval|Number
711211|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Completion/Withdrawal|The assessments are based on a 50 % or greater improvement from Baseline to Completion/Withdrawal in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)|Of the 846 subjects in the Safety Set (SS), 841 are included in this analysis. Data not available for 5 subjects.||percentage of participants||95% Confidence Interval|Number
711212|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 240|The assessments are based on a 50 % or greater improvement from Baseline to Week 240 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 240 of the open-label study|Of the 846 subjects in the Safety Set (SS), 183 are included in this analysis. Data not available for 663 subjects.||percentage of participants||95% Confidence Interval|Number
711213|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 192|The assessments are based on a 50 % or greater improvement from Baseline to Week 192 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 192 of the open-label study|Of the 846 subjects in the Safety Set (SS), 537 are included in this analysis. Data not available for 309 subjects.||percentage of participants||95% Confidence Interval|Number
711214|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 144|The assessments are based on a 50 % or greater improvement from Baseline to Week 144 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 144 of the open-label study|Of the 846 subjects in the Safety Set (SS), 602 are included in this analysis. Data not available for 244 subjects.||percentage of participants||95% Confidence Interval|Number
711215|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 96|The assessments are based on a 50 % or greater improvement from Baseline to Week 96 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 96 of the open-label study|Of the 846 subjects in the Safety Set (SS), 668 are included in this analysis. Data not available for 178 subjects.||percentage of participants||95% Confidence Interval|Number
711216|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 48|The assessments are based on a 50 % or greater improvement from Baseline to Week 48 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 48 of the open-label study|Of the 846 subjects in the Safety Set (SS), 733 are included in this analysis. Data not available for 113 subjects.||percentage of participants||95% Confidence Interval|Number
711217|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Completion/Withdrawal|The assessments are based on a 20 % or greater improvement from Baseline to Completion/Withdrawal in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)|Of the 846 subjects in the Safety Set (SS), 841 are included in this analysis. Data not available for 5 subjects.||percentage of participants||95% Confidence Interval|Number
711241|NCT00176436|Primary|Change From Baseline in Weight|Weight loss was measured each week over the 24 week study period. Intent to treat analyses of treatment effects on the primary outcome (weight) were conducted using all observed weight measurements from all participants with post-baseline weight measurements, using the mixed model for unbalanced repeated measures ANOVA. This model summarizes change in weight for each participant by the average change in weight per week (slope) over 24 weeks, and compares these slopes between the two groups.|Weekly for 24 weeks|||kilograms||Standard Deviation|Mean
711218|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 240|The assessments are based on a 20 % or greater improvement from Baseline to Week 240 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 240 of the open-label study|Of the 846 subjects in the Safety Set (SS), 183 are included in this analysis. Data not available for 663 subjects.||percentage of participants||95% Confidence Interval|Number
711219|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 192|The assessments are based on a 20 % or greater improvement from Baseline to Week 192 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 192 of the open-label study|Of the 846 subjects in the Safety Set (SS), 537 are included in this analysis. Data not available for 309 subjects.||percentage of participants||95% Confidence Interval|Number
711220|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 144|The assessments are based on a 20 % or greater improvement from Baseline to Week 144 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 144 of the open-label study|Of the 846 subjects in the Safety Set (SS), 602 are included in this analysis. Data not available for 244 subjects.||percentage of participants||95% Confidence Interval|Number
711221|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 96|The assessments are based on a 20 % or greater improvement from Baseline to Week 96 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 96 of the open-label study|Of the 846 subjects in the Safety Set (SS), 668 are included in this analysis. Data not available for 178 subjects.||percentage of participants||95% Confidence Interval|Number
711222|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 48|The assessments are based on a 20 % or greater improvement from Baseline to Week 48 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 48 of the open-label study|Of the 846 subjects in the Safety Set (SS), 733 are included in this analysis. Data not available for 113 subjects.||percentage of participants||95% Confidence Interval|Number
711223|NCT00175877|Primary|Percentage of Subjects Who Withdrew Due to an Adverse Event (AE) During the Study|An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage. The results of this Primary Outcome Measure are summarized from the Adverse Event pages of the Case Report Forms.|From Entry Visit (Week 0) to the end of the study (approximately 6.5 years)|Safety Set||percentage of participants|||Number
711224|NCT00175877|Primary|Percentage of Subjects With at Least One Serious Adverse Event (SAE) From First Certolizumab Pegol (CZP) Dose up to Approximately 7 Years|"A SAE is any untoward medical occurrence that at any dose:
Results in death
Is life-threatening
Requires in patient hospitalisation or prolongation of existing hospitalisation
Results in persistent or significant disability/incapacity, or
Is a congenital anomaly or birth defect
Is as infection that requires treatment parenteral antibiotics
Other important medical events which based on medical or scientific judgement may jeopardise the patients, or may require medical or surgical intervention to prevent any of the above
First dose of CZP was at Baseline of the preceding double-blind study [NCT00152386] for subjects randomized to CZP, or at Entry Visit (Week 0) of this study for subjects randomized to Placebo."|From first dose of CZP to the end of the open-label study (approximately 7 years)|Safety Set||percentage of participants|||Number
711225|NCT00175877|Primary|Percentage of Subjects With at Least One Adverse Event (AE) From First Certolizumab Pegol (CZP) Dose up to Approximately 7 Years|"An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage.
First dose of Certolizumab Pegol (CZP) was at Baseline of the preceding double-blind study [NCT00152386] for subjects randomized to CZP, or at Entry Visit (Week 0) of this study for subjects randomized to Placebo."|From first dose of CZP to the end of the open-label study (approximately 7 years)|Safety Set||percentage of participants|||Number
711242|NCT00176462|Secondary|To Measure 5-methyltetrahydrofolate, Aminopterin and Methotrexate Uptake in Leukemic Blasts Isolated at Diagnosis||5 years|We did not analyze this outcome measure. The laboratory analysis was not performed. The Principal Investigator left the institution.|||||
711226|NCT00176202|Secondary|Clinical Global Improvement in Bipolar Disorder Overall (CGI-BP Overall)|Severity of Illness and Global Improvement are rated on a 7-point scale by the clinician. In addition to rating the overall illness with the CGI-BP, severity and improvement are considered on various other dimensions such as mania, depression, attention deficit/hyperactivity, psychosis, aggression and sleep difficulties. Score of 1, 2 and 3 would mean there is clinically observed symptom improvement where 1 is the best outcome than 2 or 3. The point 4 is the point where the subject presents at baseline of that specific individual. If they become worse on clinical symptoms, they are rated as 5, 6 or 7 where 7 is worse than 5.|Six week study with assessment at baseline and end of the study (at the end of 6 weeks or earlier if they ended the study before 6 week end point).|||units on a scale||Standard Deviation|Mean
711227|NCT00176202|Secondary|Child Mania Rating Scale (CMRS)|Child Mania rating scale is a parent rated measure to screen for symptoms of mania. It includes 21 items reflecting the DSM-IV criteria for a manic episode. Each item is answered on a four-point Likert type scale anchored by 0 (Never/Rare), 1 (Sometimes), 2 (Often), and 3 (Very Often). Maximum score possible is 63. Score higher than 20 is considered clinically significant, and this is a dimensional score of manic severity.|Six week study with assessment at baseline and end of the study (at the end of 6 weeks or earlier if they ended the study before 6 week end point).|||units on scale||Standard Deviation|Mean
711228|NCT00176202|Secondary|Child Depression Rating Scale- Revised (CDRS-R)|Response for depressive symptoms was defined as a score less than 40 on the CDRS-R. Range is 18 to 120. Score 18 is normal and higher score signifies depression. The Children’s Depression Rating Scale (CDRS) is a 16-item measure used to determine the severity of depression in children 6-18 years of age. Items are measured on 3-, 4-, 5-, and 6-point scales. The mean and standard deviation are measured in this study to illustrate outcome at baseline and when the subject ended the study.|Six week study with assessment at baseline and end of the study (at the end of 6 weeks or earlier if they ended the study before 6 week end point).|||units on a scale||Standard Deviation|Mean
711229|NCT00176202|Primary|Young Mania Rating Scale (YMRS)|This measure has 11 items. The purpose of each item is to rate the severity of that abnormality in the patient. A severity rating is assigned to each of the eleven items, based on the patient's subjective report of his or her condition over the previous forty-eight hours and the clinician's behavioral observations during the interview, with the emphasis on the latter. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. Total score of zero to 60 is possible, zero being normal and 60 being severe, 12 serving as a cut off point for illness if equal or above. There are several ways to show change in outcome. We show the mean and standard deviation at week 0 and 6.|Six week study with assessment at baseline and end of the study (at the end of 6 weeks or earlier if they ended the study before 6 week end point).|Inclusion criteria were a DSM-IV diagnosis of bipolar disorder Type I (mixed or manic episode); 8 to 18 years old; and medication free or currently clinically unstable on medication, justifying termination of the ineffective regimen.||units on a scale||Standard Deviation|Mean
711230|NCT00176228|Secondary|Child Depression Rating Scale (CDRS-R)|Response for depressive symptoms was defined as a score less than 40 on the CDRS-R. Range is 18 to 120. Score 18 is normal and higher score signifies depression. The Children’s Depression Rating Scale (CDRS) is a 16-item measure used to determine the severity of depression in children 6-18 years of age. Items are measured on 3-, 4-, 5-, and 6-point scales. The mean and standard deviation at week 0, 8 and 14 will indicate if there is a change in the scores with the treatment.|weekly at baseline and each week during osing (8 weeks) and dose stabilized phase (6 weeks)|||units on a scale||Standard Deviation|Mean
711231|NCT00176228|Primary|Young Mania Rating Scale (YMRS),|This measure has 11 items. The purpose of each item is to rate the severity of that abnormality in the patient. A severity rating is assigned to each of the eleven items, based on the patient’s subjective report of his or her condition over the previous forty-eight hours and the clinician’s behavioral observations during the interview, with the emphasis on the latter. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. Total score of zero to 60 is possible, zero being normal and 60 being severe, 12 serving as a cut off point for illness if equal or above. There are several ways to show change in outcome. The mean and standard deviation at week 0, 8 and 14 will indicate if there is a change in the scores with the treatment.|Weekly during the 8 week lamotrigine dose titration and 6 week full dose phase.|||units on a scale||Standard Deviation|Mean
711232|NCT00176254|Secondary|5 Year Progression Free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|5 years|||participants|||Number
711233|NCT00176254|Secondary|5 Year Disease-specific Survival|Outcome is calculated from the time of enrollment to the time of death due to disease under study or survival to 5 years without death from disease under study, whichever occurs first.The 5-year rates of disease-specific survival were calculated using the Kaplan-Meier method.|5 years|||participants|||Number
711234|NCT00176254|Secondary|5 Year Overall Survival Rates||5 years post study|||participants|||Number
711235|NCT00176254|Secondary|Frequency of Severe (>/= Grade 3) Toxicities||assessed starting on day 1 through study day 58 or until toxicity resolves|Intent to Treat||adverse events|||Number
711236|NCT00176254|Primary|Response Rate to Induction Chemotherapy Prior to Definitive Therapy (Surgery or Radiation)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|assessed pre-study and once between days 36-57|||participants|||Number
711237|NCT00176306|Primary|Area Under the Curve|The objective of this study is to determine if therapeutic concentrations are likely after giving a standard dose of levofloxacin to critically ill obese individuals|24 hours|pilot study||mg/L*hr||Standard Deviation|Mean
711238|NCT00176436|Secondary|Chemistry Panel||baseline, 10 weeks and 24 weeks||||||
711239|NCT00176436|Secondary|Vital Signs||Weekly for 24 weeks||||||
711240|NCT00176436|Secondary|Secondary Outcomes Are Improvement in Cognitive Impairments, Since Atomoxetine is Used for Treatment of ADHD and is Known to Improve Cognitive Function.||24 weeks||||||
711249|NCT00176501|Primary|Response Rate|With regard to responses, this trial will use a two-stage Simon’s design optimized to minimize the expected number of patients accrued into the study. The maximum sample size will be 35 subjects. 18 subjects will be accrued during stage 1. If there are 2 or fewer responses during this stage, the trial will be stopped early. If there are 3 or more responses during this stage, an additional 19 patients will be accrued for stage 2. If 6 or fewer responses (out of 35) are observed by the end of the trial, then no further investigation of this therapy is warranted.|5 years|The study was closed early due to slow accrual and insufficient data were collected to analyse this outcome measure.|||||
711250|NCT00176605|Secondary|Toxicities Related to Chronic Administration of Etoposide and Cyclophosphamide in Patients With Stage D0 Prostate Cancer.|All patients who receive one dose of protocol therapy will be evaluable for toxicity. A total of 15 patients received at least one dose of protocol therapy. Adverse events are described in Adverse Event section.|5 years|No subjects experienced serious adverse events related to the intervention.||participants|||Number
711251|NCT00176605|Primary|PSA Response Rate|The PSA response rate is the percentage of patients who have a PSA response. A PSA response will be considered a PSA decline of at least 50% must be confirmed by a second PSA value four or more weeks later. The reference PSA for these declines should be a PSA measured within 2 weeks prior to the initiation of therapy. Patients may not demonstrate clinical or radiographic evidence of disease progression during this period.|5 years|||percentage of participants|||Number
711252|NCT00176631|Secondary|Proportion of Patients With a Decrease in BCL-2 Levels in PBMC and in the Degree of Plasma ER Receptor, Between Patients Who Responded to Treatment and Patients Who Did Not||7 years|The study was closed early due to slow accrual and insufficient data were collected to assess this outcome measure.|||||
711253|NCT00176631|Primary|Percentage of Patients With PSA Response|Decline from baseline value by > 50%, or normalization of PSA (defined as PSA less than 0.2 ng/ml), confirmed by a second measurement at least 1 or more weeks later.|7 years|The study was closed early due to slow accrual and insufficient data were collected to assess this outcome measure.|||||
711254|NCT00176644|Secondary|To Assess the Plateau Level of Estradiol That is Attained With the Dose of 0.4mg/Day Given Via Transdermal Estradiol Patch and in Addition, Assess the Response on Testosterone in the Androgen Resistant Population.||4 years|Analysis was not conducted as therapy was determined to be ineffective (response rate < 20%).|||||
711255|NCT00176644|Secondary|To Evaluate Time to Progression.||4 years|Analysis was not conducted as therapy was determined to be ineffective (response rate < 20%).|||||
711256|NCT00176644|Secondary|To Evaluate Measurable Disease Response in Patients With Hormone and Chemotherapy Refractory Prostate Cancer.||4 years|Analysis was not conducted as therapy was determined to be ineffective (response rate < 20%).|||||
711257|NCT00176644|Secondary|To Measure Quality of Life of Patients Receiving Therapy With the Functional Assessment of Cancer Therapy-Prostate Scale (FACT-P).||4 years|Analysis was not conducted as therapy was determined to be ineffective (response rate < 20%).|||||
711258|NCT00176644|Primary|To Evaluate the Antitumor Activity, as Measured by PSA Response Rate in Patients With Hormone and Chemotherapy Refractory Prostate Cancer.||4 years|||Response rate (percentage)|||Number
711259|NCT00176800|Secondary|Percentage of Patients That Require Dose Modification Due to Toxicity||8 years|||percentage of patients|||Number
711260|NCT00176800|Secondary|Median Overall Survival Time|To measure the survival time in patients treated with preoperative chemoradiation, surgery, and post-operative tetrathiomolybdate.|8 years|||months||95% Confidence Interval|Median
711261|NCT00176800|Primary|Median Recurrence Free Survival Time|To measure the time recurrence in patients with esophageal cancer treated with preoperative chemoradiation, surgery, and post-operative tetrathiomolybdate.|8 years|||months||95% Confidence Interval|Median
711262|NCT00176826|Secondary|Number of Patients Surviving (Disease-free)||3 years|||participants|||Number
711263|NCT00176826|Secondary|Number of Patients With III-IV Graft-Versus-Host Disease (GVHD)||Day 100 Post Transplant|||participants|||Number
711264|NCT00176826|Secondary|Number of Patients With Graft Failure||Day 100 Post transplant|||participants|||Number
711265|NCT00176826|Secondary|Number of Patients With Grade II-IV Graft-Versus-Host Disease (GVHD)||Day 100 Post Transplant|||participants|||Number
711266|NCT00176826|Secondary|Number of Patients Surviving (Disease-free)||1 year|||participants|||Number
711267|NCT00176826|Secondary|Number of Patients With Treatment Related Mortality.||Day 100 Post Transplant|||participants|||Number
711268|NCT00176826|Primary|Time to Transplant Engraftment||Day 100 Post Transplant|||days||Standard Deviation|Mean
711269|NCT00176839|Secondary|Incidence of Relapse|Number of patients with relapse after being treated with busulfan (BU), cyclophosphamide (CY) and melphalan (L-PAM) followed by HCT for hematological malignancies.|1 year|||participants|||Number
711270|NCT00176839|Secondary|Incidence of Regimen-related Toxicity 100 Days Post Transplant|Number of participants with regimen-related toxicity 100 days post transplant after being treated with busulfan (BU), cyclophosphamide (CY) and melphalan (L-PAM) followed by HCT for hematological malignancies.|100 days post-transplant|||participants|||Number
711271|NCT00176839|Secondary|Incidence Chronic Graft-versus-host Disease (GVHD)|Number of participants with chronic GVHD after being treated with busulfan (BU), cyclophosphamide (CY) and melphalan (L-PAM) followed by HCT for hematological malignancies.|1 year|||participants|||Number
711272|NCT00176839|Secondary|Incidence of Acute Graft-versus-host Disease (GVHD)|Number of participants with acute GVHD after being treated with busulfan (BU), cyclophosphamide (CY) and melphalan (L-PAM) followed by HCT for hematological malignancies.|100 days post-transplant|||participants|||Number
711273|NCT00176839|Secondary|Probability of Engraftment|Number of participants with engraftment after being treated with busulfan (BU), cyclophosphamide (CY) and melphalan (L-PAM) followed by HCT for hematological malignancies..|1 year|||participants|||Number
711274|NCT00176839|Primary|Probability of Long-term Disease-free Survival (DFS)|Number of participants with long-term disease free survival after being treated with busulfan (BU), cyclophosphamide (CY) and melphalan (L-PAM) followed by HCT for hematological malignancies.|1 year|||participants|||Number
711275|NCT00176852|Secondary|Disease Free Survival|Number of patients alive without disease 1 year after transplant.|1 year|||Participants|||Count of Participants
711276|NCT00176852|Secondary|Disease Free Survival|Number of patients alive without disease 100 days after transplant.|100 days|||Participants|||Count of Participants
711281|NCT00176852|Secondary|Change in the Patient's Quality of Life as Compared to the Pre-Transplant Assessment|"The measure for quality of life used in this study is the Karnofsky Performance Score. The Karnofsky Performance Score runs from 100 to 0, where 100 is perfect health and 0 is death."|5 years|The 5 year time point will not be ready for analysis until 2019.|||||
711282|NCT00176852|Secondary|Change in the Patient's Quality of Life as Compared to the Pre-Transplant Assessment|"The measure for quality of life used in this study is the Karnofsky Performance Score. The Karnofsky Performance Score runs from 100 to 0, where 100 is perfect health and 0 is death."|2 years|Two of the 14 patients treated on Arm A2 died before 2 years and 2 failed their 2 year clinic appointment.||units on a scale||Full Range|Median
711283|NCT00176852|Secondary|Change in the Patient's Quality of Life as Compared to the Pre-Transplant Assessment|"The measure for quality of life used in this study is the Karnofsky Performance Score. The Karnofsky Performance Score runs from 100 to 0, where 100 is perfect health and 0 is death."|1 year|Two of the 14 patients treated on Arm A2 died before 1 year.||units on a scale||Full Range|Median
711284|NCT00176852|Secondary|Change in the Patient's Quality of Life as Compared to the Pre-Transplant Assessment|"The measure for quality of life used in this study is the Karnofsky Performance Score. The Karnofsky Performance Score runs from 100 to 0, where 100 is perfect health and 0 is death."|pre-transplant|||units on a scale||Full Range|Median
711285|NCT00176852|Secondary|The Incidence of Chronic Graft Versus Host Disease (Chronic GVHD)|The number of patients who experienced Chronic GVHD. Chronic GVHD is when the donated bone marrow or peripheral blood stem cells view the recipient’s body as foreign, and the donated cells/bone marrow attack the body. Chronic GVHD can appear at any time after allogeneic transplant or several years after transplant.|1 year|||Participants|||Count of Participants
711286|NCT00176852|Secondary|The Incidence of Chronic Graft Versus Host Disease (Chronic GVHD)|The number of patients who experienced Chronic GVHD. Chronic GVHD is when the donated bone marrow or peripheral blood stem cells view the recipient’s body as foreign, and the donated cells/bone marrow attack the body. Chronic GVHD can appear at any time after allogeneic transplant or several years after transplant.|6 months|||Participants|||Count of Participants
711287|NCT00176852|Secondary|The Incidence of Grade 3-4 Acute Graft Versus Host Disease (Acute GVHD)|The number of patients who experienced grades 3-4 Acute GVHD. Acute GVHD is when the donated bone marrow or peripheral blood stem cells view the recipient’s body as foreign, and the donated cells/bone marrow attack the body. IGrades 3-4 equate to moderate to severe disease. Symptoms typically appear within weeks after transplant.|100 days|||Participants|||Count of Participants
711288|NCT00176852|Secondary|The Incidence of Grade 2-4 Acute Graft Versus Host Disease (Acute GVHD)|The number of patients who experienced grades 2-4 Acute GVHD. Acute GVHD is when the donated bone marrow or peripheral blood stem cells view the recipient’s body as foreign, and the donated cells/bone marrow attack the body. Grades 2-4 equate to mild to severe disease. Symptoms typically appear within weeks after transplant.|100 days|||Participants|||Count of Participants
711289|NCT00176852|Secondary|The Incidence of Chimerism at 1 Year|The number of patients whose blood and/or bone marrow contains > 10% donor cells.|1 year|One of the 3 patients treated on Arm A was retreated at Day 40 and was not evaluable. One of the 14 patients on Arm A2 died before 1 year.||Participants|||Count of Participants
711290|NCT00176852|Secondary|The Incidence of Chimerism at 6 Months|The number of patients whose blood and/or bone marrow contains > 10% donor cells.|6 months|One of the 3 patients treated on Arm A was retreated at Day 40 and was not evaluable. One of the 14 patients on Arm A2 died before 6 months.||Participants|||Count of Participants
711291|NCT00176852|Secondary|The Incidence of Chimerism at 100 Days|The number of patients whose blood and/or bone marrow contains > 10% donor cells.|100 days|One of the 3 patients treated on Arm A was retreated at Day 40 and was not evaluable. One of the 14 patients on Arm A2 died before 100 days.||Participants|||Count of Participants
711292|NCT00176852|Primary|Number of Patients Who Experienced Grade 3-5 Treatment Related Toxicity|In general, grade 3 equates to moderate, grade 4 to severe and grade 5 to death.|1 year|||Participants|||Count of Participants
711293|NCT00176865|Secondary|Compare Quality of Life (QOL)||Pretransplant, 1 year, 2 years and 5 years|PI made decision after IRB approval, but before opening the study to accrual, to not collect QOL data .|||||
711294|NCT00176865|Secondary|Number of Subjects Alive at One Year||Day 365|||participants|||Number
711295|NCT00176865|Secondary|Number of Subjects Alive at 100 Days||Day 100|||participants|||Number
711296|NCT00176865|Secondary|Incidence of Chronic Graft Versus Host Disease (cGVHD)|Chronic graft versus host disease (cGVHD) is a reaction which typically develops 3 to 6 months after transplant where the T- cells of the donor graft attacks the recipient's (host's) skin, GI tract, liver and other organs.|6 months and 1 year|||participants|||Number
711297|NCT00176865|Secondary|Incidence of Grade 3-4 Acute Graft Versus Host Disease (aGVHD)|Acute graft versus host disease (aGVHD) is a reaction occurring within the first 100 days after transplant where the T- cells of the donor graft attacks the recipient's (host's) skin, GI tract, liver and other organs. The severity of aGVHD is graded on a scale of 1 - 4 with the highest number representing the most severe disease.|Day 100|||participants|||Number
711298|NCT00176865|Secondary|Incidence of Grade 2-4 Acute Graft Versus Host Disease (aGVHD)|Acute graft versus host disease (aGVHD) is a reaction occurring within the first 100 days after transplant where the T- cells of the donor graft attacks the recipient's (host's) skin, GI tract, liver and other organs. The severity of aGVHD is graded on a scale of 1 - 4 with the highest number representing the most severe disease.|Day 100|||participants|||Number
711299|NCT00176865|Secondary|Percentage of Donor Chimerism at 365 Days|The percent of recipient bone marrow and blood cells that are of donor origin.|Day 365|"Arm 2: 2 of 10 patients not evaluable due to failure to return to clinic for the Day 100 evaluation.
Arm 3: 2 of 6 patients not evaluable due to early death."||percentage of donor cells||Standard Deviation|Mean
711300|NCT00176865|Secondary|Percentage of Donor Chimerism at 180 Days|The percent of recipient bone marrow and blood cells that are of donor origin.|Day 180|"Arm 2: 2 of 10 patients not evaluable due to failure to return to clinic for the Day 100 evaluation.
Arm 3: 2 of 6 patients not evaluable due to early death."||percentage of donor cells||Standard Deviation|Mean
711301|NCT00176865|Secondary|Percentage of Donor Chimerism at 100 Days|The percent of recipient bone marrow and blood cells that are of donor origin.|Day 100|"Arm 2: 2 of 10 patients not evaluable due to failure to return to clinic for the Day 100 evaluation.
Arm 3: 2 of 6 patients not evaluable due to early death."||percentage of donor cells||Standard Deviation|Mean
711304|NCT00176878|Secondary|Number of Patients With Chronic Graft Versus Host Disease|Number of patients who exhibited chronic (normally occurs after 100 days) Graft Versus Host Disease at 2 years post transplant. Chronic graft-versus-host-disease, over its long-term course, can also cause damage to the connective tissue and exocrine glands.|2 years|||Participants|||Number
711305|NCT00176878|Secondary|Number of Patients With Grade 2-4 Acute Graft Versus Host Disease|Number of patients with Grade 2, 3 and 4 Acute (normally observed within the first 100 days) Graft Versus Host Disease. Acute GVHD is staged as follows: overall grade (skin-liver-gut) with each organ staged individually from a low of 1 to a high of 4. Patients with grade IV GVHD usually have a poor prognosis. Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening.|100 Days|||Participants|||Number
711306|NCT00176878|Secondary|Number of Patients With Succcessful Engraftment After Transplantation|"Number of patients who received non-genotypic identical marrow or cord blood cells using a non-myeloablative preparative regimen and exhibited engraftment at Day 42."|42 Days|||Participants|||Number
711307|NCT00176878|Secondary|Number of Patients Alive at Three Years (Survival)|Number of subjects who survived 3 years post-transplant.|3 years|||Participants|||Number
711308|NCT00176878|Primary|Number of Patients Alive (Survival) at 2 Years|Calculated from day 1 of transplant to last contact.|2 years|||Participants|||Number
711309|NCT00176904|Secondary|Number of Patients With Chronic Graft-Versus-Host Disease|Number of patients who exhibited chronic graft-versus-host disease by 1 Year post transplant. Graft-versus-host disease (GVHD) is a complication that can occur after a stem cell or bone marrow transplant in which the newly transplanted material attacks the transplant recipient's body. Chronic GVHD is an extension of this syndrome.|1 Year Post Transplant|||Participants|||Number
711310|NCT00176904|Secondary|Number of Patients With Grade III-IV Acute Graft-Versus-Host Disease|Number of patients who exhibited acute graft-versus-host disease by Day 100 post transplant. Graft-versus-host disease (GVHD) is a complication that can occur after a stem cell or bone marrow transplant in which the newly transplanted material attacks the transplant recipient's body. Grade I=mild, Grade II=moderate, Grade III=severe, Grade IV=life threatening.|Day 100|||Participants|||Number
711311|NCT00176904|Secondary|Number of Patients With Grade II-IV Acute Graft-Versus-Host Disease|Number of patients who exhibited acute graft-versus-host disease by Day 100 post transplant. Graft-versus-host disease (GVHD) is a complication that can occur after a stem cell or bone marrow transplant in which the newly transplanted material attacks the transplant recipient's body. Grade I=mild, Grade II=moderate, Grade III=severe, Grade IV=life threatening.|Day 100|||Participants|||Number
711312|NCT00176904|Secondary|Overall Donor Engraftment|Number of patients with full donor chimerism (state in bone marrow transplantation in which bone marrow and host cells exist compatibly without signs of graft-versus-host rejection disease) by Day 100 post-transplant of at least 90%.|Day 100|1 Patient not included due to early death (before day 40).||Participants|||Number
711313|NCT00176904|Primary|Overall Survival|Number of patients alive at designated timepoints after transplant.|100 Days, 1 Year and 3 Years|||Participants|||Number
711314|NCT00176917|Secondary|Number of Patients With Grade III-IV Acute Graft-versus-host Disease (aGVHD).|Toxicity (undesireable effect) of this stem cell transplant preparative regimen due to acute graft-versus-host disease.|Day 100 Post Transplant|||Participants|||Number
711315|NCT00176917|Secondary|Number of Patients Who Failed Engraftment.|Toxicity (undesireable effect) of hematologic donor cell engraftment is determined by failure to engraft at Day 42.|Day 42 Post Transplant|1 patient of 41 failed engraftment - per protocol.||Participants|||Number
711316|NCT00176917|Secondary|Number of Patients Surviving on Study|Number of patients surviving (alive) at specified timepoints.|at 100 days, 1 year, and 3 years post transplant|Day 100 and 1 Year timepoints include all 41 patients. Year 3 includes 36 patients (5 pts not yet at followup timepoint.)||Participants|||Number
711317|NCT00176917|Primary|Mean Percentage of Donor Cells in Study Population (Chimerism).|Donor-derived engraftment determined by restriction fragment length polymorphism (RFLP).|at 21 days, 42 days, 60 days, 100 days, 6 months, and 1 year|Day 21 (24 patients included), Day 42 (15 pts), Day 60 (29 pts), Day 100 (25 pts), 6 Months (18 pts), 1 Year (16 pts).||Percentage||Standard Deviation|Mean
711318|NCT00177164|Secondary|Number of Participants With Treatment Emergent Hyperlipidemia|Number of participants with Hyperlipidemia as determined by safety labs|from baseline to end of 15 months|patients with bipolar disorder||participants|||Number
711319|NCT00177164|Secondary|Number of Participants With Treatment - Emergent Hyperglycemia|Number of participants with hyperglycemia based on safety labs|from baseline to end of 15 months|patients with bipolar disorder||participants|||Number
711320|NCT00177164|Secondary|BMI|BMI at baseline and at end of 15 months for Risperidone LAI and oral AAP groups|baseline to end of 15 months|Patients with bipolar disorder||kg / m^2||Standard Deviation|Mean
711321|NCT00177164|Primary|Evaluate the Number of Clinical Events (Pooled) Occurring Between 3-15 Months Following a Switch/Stabilization of the Antipsychotic Agents Among Patients Who Receive Either Risperidal Consta or One of the 4 Marketed 2nd Generation Antipsychotic Agents.||Upto 15 months|2 patients in the risperidone LAI group were not included in the ITT (intention to treat) analyses as they did not receive assessment after the baseline assessment. Therefore, outcomes were assessed for only 23 of 25 patients in the risperidone LAI group.||Number of clinical events||Standard Deviation|Mean
711322|NCT00177216|Primary|Change in Diary Sleep Efficiency|The change in self-report sleep efficiency calculated from 7-day sleep diary (DSE): Sleep efficiency is the percent of (time spent asleep divided by the amount of time between good night time and final awakening). It ranges from 0 (no sleep at all) to 100 (asleep the second your head hits the pillow until you wake up in the morning and get out of bed). Participants report the time they go to bed, how long they think it takes them to fall asleep, how many minutes they are awake during the night, and then what time they finally wake up in the morning. These values are used to calculate the diary sleep efficiency for each night and then we averaged these across the 7 days of diary collected pre and post treatment. The values below are post treatment DSE minus pre treatment DSE. A positive number means that the DSE was higher (better) post treatment.|post treatment minus baseline. This averaged 69 days.|The number of subjects with sleep diaries at baseline and after at least 5 weeks of treatment. Not all of these participants 'completed' the protocol||diff score of diary Sleep Efficiency||Standard Deviation|Mean
720902|NCT00303953|Secondary|Overall Survival|Measured from time of registration to death, or last contact date|assessed every 3 months for 3 years|Only eligible patients were included in the analyses.||years||95% Confidence Interval|Median
711323|NCT00177216|Primary|Change in Pittsburgh Sleep Quality Index|Self-report measure of sleep quality developed at University of Pittsburgh by Daniel J. Buysse, M.D. The PSQI total score ranges from 0 to 21 with 0 being marvelous sleep and 21 being horrid sleep. The difference score, reported below, is the total score after at least 5 weeks of treatment in one of the three arms, minus the baseline total score. A negative score means that the sleep of the participant improved.|post treatment minus baseline assessment battery. This averaged 100 days.|Number of subjects who had total PSQI scores after at least 5 weeks of treatment. The PSQI requires that all questions be answered for a total score to be calculated. This analysis includes participants who did not complete the protocol and also omits those who has missing total scores due to missing items on the PSQI||difference score of PSQI total||Standard Deviation|Mean
711324|NCT00177216|Secondary|Change in PSG Sleep Efficiency for the Second Night in the Sleep Lab at Each Timepoint|Change in PSG Sleep Efficiency (SE) between post-treatment and baseline: Sleep efficiency is the percent of time spent asleep divided by the total sleep recording period in the sleep lab. This value is calculated using the results of the polysomnographic sleep study. It ranges from 0 (no sleep at all) to 100 (asleep the second the sleep recording starts (GNT) until the sleep recording ends (GMT) in the morning). The values below are post treatment SE minus pre treatment SE. A positive number means that the SE was higher (better) post treatment.|post treatment minus baseline PSG sleep studies. This averaged 70 days|Number of subjects who had polysomnography at Week 9 and at pretreatment. Some of the participants who 'completed' the protocol did not have follow up sleep studies.||difference score for SE||Standard Deviation|Mean
711325|NCT00177255|Secondary|Overall Response Rate|The number of responders (complete responders + partial responders) divided by the number of evaluable patients.|Every 2 cycles (6 weeks)|||percentage of participants||95% Confidence Interval|Number
711326|NCT00177255|Primary|Overall Survival|The time interval between the date on which a patient first received protocol treatment and the documented date of death.|2 years|||Months||95% Confidence Interval|Median
711327|NCT00177294|Primary|Remission|Three consecutive weekly scores of less than 7 on the Hamilton Rating Scale for Depression (N=17 item). Scores on the Hamilton Rating Scale for Depression(HRSD) range from 0 to 58, with higher scores indicating more severe depression.|Measured at Week 6 or 22|||Percentage of participants||95% Confidence Interval|Number
711328|NCT00177307|Secondary|1-, 2-, and 3-year Overall Survival|Probability of being alive at 1-, 2-, and 3-years from start of protocol therapy|Up to 40 months|||percent chance|||Number
711329|NCT00177307|Secondary|Overall Survival|time from start of protocol therapy until death from any cause|Up to 40 months|||Months||95% Confidence Interval|Median
711330|NCT00177307|Secondary|Response Rate (RR)|Percentage of partial responses (PR) + complete responses (CR).|Up to 27 months|||percentage of participants|||Number
711331|NCT00177307|Primary|Progression Free Survival (PFS)|time from start of protocol therapy until objective tumor progression or death|Up to 27 Months|||Months||95% Confidence Interval|Median
711332|NCT00177671|Post-Hoc|Percentage of Participants With Mild Cognitive Impairment Converting to Dementia.|Conversion to dementia was ascertained by the University of Pittsburgh Alzheimer Disease Research Center (ADRC), using data on neuropsychological performance and IADL functioning, as well as other relevant clinical data. Diagnoses were made according to National Alzheimer Coordinating Center criteria.|2 year|This is the percent of participants with mild cognitive impairment (MCI) in each arm of the study.||Percent of Participants|||Number
711333|NCT00177671|Primary|Number of Participants With Recurrence of Major Depression|Recurrence of major depressive episodes as determined by SCID/DSM IV: two weeks of low mood and/or anhedonia, together with at least five of the following symptoms: suicidal ideation, low energy, sleep disturbance, appetite disturbance, psychic anxiety or somatic anxiety. In addition, a diagnosis of major depression requires evidence of distress or impairment.|2 years|||participants||95% Confidence Interval|Number
711334|NCT00177671|Primary|Cognitive Instrumental Activities of Daily Living (IADL)|The PASS (a performance-based assessment of instrumental activities of daily living)generates a composite measure of 13 cognitive IADL items capturing performance on activities such as shopping, bill paying, medication management, and home safety. We report the percentage of subjects at each assessment point adjudged to have independent functioning. This was determined by a clinician rater observing subjects perform each task and rating them according to predetermined criteria on a 4 point scale, ranging from 0 (unable) to 3 (independent).|baseline, year 1 and year 2|Some participants refused this testing.||Percentage of participants|||Number
711335|NCT00177671|Primary|Global Cognitive Performance|Cognitive performance was assessed with 17 well established and validated individual tests measuring multiple domains. We transformed raw scores for individual tests into Z-scores using the baseline distribution of a non-depressed, cognitively normal, older adult comparison group (N=36)of similar age, education, and medical health recruited concurrently with the depressed participants. These Z-scores were averaged within each neuropsychological area to produce domain scores and then averaged over all 17 tests to calculate a global cognition performance score.|Measured at baseline and Years 1 and 2 in maintenance|||Z-score||Standard Deviation|Mean
711336|NCT00177866|Secondary|Change in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Scores in Response to Treatment|No results or publication, data destroyed due to age of study.|completion of all study participants||||||
711337|NCT00177866|Primary|Change in Crohn's Disease Activity Index (CDAI) Scores in Response to Treatment|Change in Crohn's Disease Activity Index (CDAI) scores in response to treatment|completion of all study participants|No results or publication, data destroyed due to age of study.|||||
711338|NCT00177970|Secondary|6) Patients' Length of Hospital Stay|During the course of the study, we expect the IVIG group compared to the placebo group will have a decrease in length of hospital stay.|during the course of the study|No results available record destroyed due to age of study. no publications|||||
711339|NCT00177970|Secondary|5) Normalization of Body Temperature During a 24 Hour Period|During the course of the study, we expect the IVIG group compared to the placebo group will have a normal body temperature of 98.6 F.|during the course of the study|No results available record destroyed due to age of study. no publications|||||
711340|NCT00177970|Secondary|4) Normalization of Neutrophil Count on CBC With Diff.|During the course of the study, we expect the IVIG group compared to the placebo group will have normalization of neutrophil count (1.6-6.7)on CBC with diff.|during the course of the study|No results available record destroyed due to age of study. no publications|||||
711341|NCT00177970|Secondary|3) Correlation Between Antibody Responses as Measured With ELISA (Enzyme Immunoassay) and Recovery of C. Difficile Diarrhea|A correlation will occur between antibody responses as measured with ELISA (enzyme immunoassay) and recovery of C. difficile diarrhea.|during the course of the study|No results available record destroyed due to age of study. no publications|||||
711342|NCT00177970|Secondary|2) Quantity of Anti-C. Difficile Antibodies in Relationship With Recovery of C. Difficile Diarrhea|The quantity of anti-C. difficile antibodies with improve in relationship with recovery|during the course of the study|No results available record destroyed due to age of study. no publications|||||
711343|NCT00177970|Secondary|1) 75% Reduction in Abdominal Pain/Tenderness|During the course of the study, we expect the IVIG group compared to the placebo group will a 75% reduction in abdominal pain/tenderness|during the course of the study|No results available record destroyed due to age of study. no publications|||||
711344|NCT00177970|Primary|2) Decrease of Number of Loose Stools to <3 Per Day Following Treatment|During the course of the study, we expect the IVIG group compared to the placebo group will have fewer number of stools per day (<3 per day).|during the course of the study|No results available record destroyed due to age of study. no publications|||||
711345|NCT00177970|Primary|1) Normalization of WBC's|During the course of the study, we expect the IVIG group compared to the placebo group will have a normal WBC count 3.8-10.0/CMM|during the course of the study|No results available record destroyed due to age of study. no publications|||||
711346|NCT00178126|Primary|Sitting-induced Pressure Ulcers||6 months|||participants|||Number
711347|NCT00178178|Primary|Pain|Pain over the first three days post-operatively. This will be identified by the use of the Postoperative Patient Diary. This document records patient's subjective evaluations of pain, comfort, ability to sleep, activity administered daily on the day of surgery and each morning and each evening before the patient retires for 3 postoperative days. All pain medications taken during the 3 days of the postoperative evaluation will be recorded on the Postoperative Patient Diary.|3 day|||participants that experienced pain|||Number
711348|NCT00178191|Primary|Episodes/Day|number of incontinence episodes/day|9 months|||number||Standard Error|Mean
711349|NCT00170625|Secondary|Progression-free Survival|progression-free survival according to kaplan-meier-estimator|after every third cycle, for up to one year|||months||95% Confidence Interval|Median
711350|NCT00170625|Primary|Toxicity|hematological adverse events and non-hematological adverse events grade 3/4|after each cycle for up to one year|||participants|||Number
711351|NCT00170846|Secondary|Number of Participants With Safety Parameters|The selected safety parameters (such as hypertension, hyperlipidemia, diabetes mellitus, anemia, malignancies ) were derived based on adverse events preferred terms defined in the analysis plan.|24 months|Safety Population. The Safety Population consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline safety assessment.||Participants|||Number
711352|NCT00170846|Post-Hoc|Change in mGFR by Baseline Calculated Creatinine Clearance (Cockcroft-Gault Formula)|"Cockcroft-Gault formula (CrCl):
Creatinine Clearance [mL/min] = CrCl (males) = (140 – A) * W / (72 * C) (males), CrCl (females) = CrCl (males) * 0.85,
Where:
A is age [years]
W is body weight [kg]
C is the serum concentration of creatinine [mg/dL]"|Baseline and 24 months|Per Protocol Population. The per-protocol (PP) population consisted of the ITT patients excluding those patients with major protocol deviations and those patients who were not able to initiate their randomized regimens as scheduled.||mL/min||Standard Deviation|Mean
711353|NCT00170846|Primary|Renal Function Assessed by Measured GFR (mGFR)|The acceptable methods for GFR measurement were Chromium 51-Ethylenediaminetetra acetic acid (Cr-EDTA), Technetium 99-Diethylenetriaminepentacetic acid (Tc-DTPA), Iohexol clearance Inuline clearance and Iothalamate clearance. The method should have been consistent for a given patient at every time point.|24 months|The modified ITT population included all ITT patients who had mGFR or calculated GFR (cGFR) at Month 24 based on all values including those collected after discontinuation of study medication.||mL/min/1.73m^2||Standard Deviation|Mean
711354|NCT00170950|Secondary|Time-to-event Analysis of Percentage of Patients With a Cardiovascular (CV) Mortality Event, Non-fatal Myocardial Infarction (MI), or Non-fatal Stroke|CV mortality was defined as death due to sudden cardiac death, fatal MI, fatal stroke, coronary intervention, congestive heart failure (CHF), or other CV causes.|For each patient, baseline to time of first CV mortality event, MI (non-fatal), or stroke (non-fatal) (or last exposure if no event occurred). (Median duration of exposure was 33.4 months. [25th to 75th percentiles: 21 to 41 months.])|Intent-to-treat population: All randomized patients by assigned treatment group||Percentage of Patients with an Event|||Number
711355|NCT00170950|Secondary|Time-to-event Analysis of Percentage of Patients With a Composite Cardiovascular (CV) Morbidity Event|Cardiovascular morbidity was defined as including any of the following events: non-fatal MI, non-fatal stroke, hospitalization for unstable angina, resuscitated sudden death, or coronary revascularization procedure (PCI or CABG).|For each patient, baseline to time of first CV morbidity event (or last exposure if no event occurred). (Median duration of exposure was 33.4 months. [25th to 75th percentiles: 21 to 41 months.])]|Intent-to-treat population: All randomized patients by assigned treatment group||Percentage of Patients with an Event|||Number
711356|NCT00170950|Primary|Time-to-event Analysis of Percentage of Patients With a Composite Cardiovascular (CV) Morbidity or Mortality Event|CV morbidity was defined as non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina, resuscitated sudden death, or coronary revascularization procedure. CV mortality was defined as death due to MI, stroke, coronary intervention, congestive heart failure (CHF), sudden cardiac death, or other CV causes.|For each patient, baseline to time of first CV morbidity or mortality event (or last exposure if no event occurred). (Median duration of exposure was 33.4 months. [25th to 75th percentiles: 21 to 41 months.])|Intent-to-treat population: All randomized patients by assigned treatment group||Percentage of Patients with an event|||Number
711357|NCT00171054|Secondary|Changes in Central Blood Pressure, Evaluated by Applanation Tonometry From Baseline at Weeks 12 and 38|Central Blood Pressure was measured via applanation tonometry recordings of the common carotid artery and from brachial oscillometric recordings. The Simultaneously obtained carotid artery pressure and standard brachial artery blood pressure are computed to obtain the central systolic pressure.|Baseline, Week 12 and Week 38|Intent-to-treat. The intent to treat population is defined as those who provide a baseline measure and at least one post-baseline measurement (not necessarily an endpoint measure)||mm Hg||Standard Error|Least Squares Mean
711358|NCT00171054|Secondary|Change in Left Ventricular Mass Index (LVMI) and Diastolic Function Using Echocardiography From Baseline to Week 38||Baseline and Week 38|Intent-to-treat. The intent to treat population is defined as those who provide a baseline measure and at least one post-baseline measurement (not necessarily an endpoint measure)||percent||Standard Error|Least Squares Mean
711359|NCT00171054|Secondary|Changes in Baroreflex Sensitivity as it Relates to Changes in Carotid Distensibility From Baseline to Week 38|The calculation of spontaneous baroflex sensitivity was obtained by the sequence method. Baroflex sequences are defined by at least three consecutive beats in which the systolic blood pressure and the RR interval of the following beat either both increased or decreased. The slope of each individual sequence is computed and the mean slope is determined as the average of all slopes within a given period of time and taken as the gain of the cardiac baroflex (BRSs).|Baseline and Week 38|Intent-to-treat. The intent to treat population is defined as those who provide a baseline measure and at least one post-baseline measurement (not necessarily an endpoint measure)||EP||Standard Error|Least Squares Mean
711360|NCT00171054|Secondary|Changes in Baroreflex Sensitivity as it Relates to Changes in Carotid Distensibility From Baseline to Week 12|The calculation of spontaneous baroflex sensitivity was obtained by the sequence method. Baroflex sequences are defined by at least three consecutive beats in which the systolic blood pressure and the RR interval of the following beat either both increased or decreased. The slope of each individual sequence is computed and the mean slope is determined as the average of all slopes within a given period of time and taken as the gain of the cardiac baroflex (BRSs).|Baseline and Week 12|Intent-to-treat. The intent to treat population is defined as those who provide a baseline measure and at least one post-baseline measurement (not necessarily an endpoint measure)||EP||Standard Error|Least Squares Mean
711361|NCT00171054|Secondary|Changes in Mean Right Carotid Distensibility at Week 38|For carotid distensibility, the left and right bulbs and common carotid arteries are measured using tissue Doppler imaging with the linear array probe. Absolute diameter and diameter changes over the cardiac cycles will be recorded. Distensibility of each bulb will be calculated for three consecutive heart cycles and averaged and corrected for blood pressure.|Baseline and Week 38|Intent-to-treat. The intent to treat population is defined as those who provide a baseline measure and at least one post-baseline measurement (not necessarily an endpoint measure)||percent||Standard Error|Least Squares Mean
711362|NCT00171054|Secondary|Changes in Mean Right Carotid Distensibility at Week 12|For carotid distensibility, the left and right bulbs and common carotid arteries are measured using tissue Doppler imaging with the linear array probe. Absolute diameter and diameter changes over the cardiac cycles will be recorded. Distensibility of each bulb will be calculated for three consecutive heart cycles and averaged and corrected for blood pressure.|Baseline and Week 12|Intent-to-treat. The intent to treat population is defined as those who provide a baseline measure and at least one post-baseline measurement (not necessarily an endpoint measure)||percent||Standard Error|Least Squares Mean
711363|NCT00171054|Secondary|Changes in Mean Left Carotid Distensibility at Week 38|For carotid distensibility, the left and right bulbs and common carotid arteries are measured using tissue Doppler imaging with the linear array probe. Absolute diameter and diameter changes over the cardiac cycles will be recorded. Distensibility of each bulb will be calculated for three consecutive heart cycles and averaged and corrected for blood pressure.|Baseline and Week 38|Intent-to-treat. The intent to treat population is defined as those who provide a baseline measure and at least one post-baseline measurement (not necessarily an endpoint measure)||percent||Standard Error|Least Squares Mean
711364|NCT00171054|Secondary|Changes in Mean Left Carotid Distensibility at Week 12|For carotid distensibility, the left and right bulbs and common carotid arteries are measured using tissue Doppler imaging with the linear array probe. Absolute diameter and diameter changes over the cardiac cycles will be recorded. Distensibility of each bulb will be calculated for three consecutive heart cycles and averaged and corrected for blood pressure.|Baseline and Week 12|Intent-to-treat. The intent to treat population is defined as those who provide a baseline measure and at least one post-baseline measurement (not necessarily an endpoint measure)||percent||Standard Error|Least Squares Mean
711365|NCT00171054|Secondary|Change From Baseline for Endothelial Function Measured by Brachial Artery Flow-mediated Vasodilatation (FMD) Using the Brachial Artery Reactivity Test (BART) at End-point (Week 38)|Endothelial function will be assessed using high-resolution duplex ultrasound with wall tracking to measure FMD of the brachial artery during reactive hyperemia. FMD of the brachial artery in response to reactive hyperemia in the distal forearm (and glyceryl trinitrate as a non-endothelium dependent control) will be measured from B-mode ultrasound images using a standard 7 MHz linear array transducer and HDI 5000 system with edge detection.|Baseline and Week 38|Intent-to-treat. The intent to treat population is defined as those who provide a baseline measure and at least one post-baseline measurement (not necessarily an endpoint measure)||percent||Standard Error|Least Squares Mean
711366|NCT00171054|Secondary|Change From Baseline for Endothelial Function Measured by Brachial Artery Flow-mediated Vasodilatation (FMD) Using the Brachial Artery Reactivity Test (BART) at Week 12|Endothelial function will be assessed using high-resolution duplex ultrasound with wall tracking to measure FMD of the brachial artery during reactive hyperemia. FMD of the brachial artery in response to reactive hyperemia in the distal forearm (and glyceryl trinitrate as a non-endothelium dependent control) will be measured from B-mode ultrasound images using a standard 7 MHz linear array transducer and HDI 5000 system with edge detection.|Baseline and Week 12|Intent-to-treat. The intent to treat population is defined as those who provide a baseline measure and at least one post-baseline measurement (not necessarily an endpoint measure)||percent||Standard Error|Least Squares Mean
711367|NCT00171054|Secondary|Change From Baseline in Post-ischemic Forearm Skin Reactive Hyperemia at Endpoint (Week 38)|Cutaneous blood flow was continuously recorded by a laser Doppler flowmeter. The laser Doppler flow probe was applied on the volar part of the right forearm with a plastic holder 10 cm proximal to the wrist. All measurements were made with a pressure cuff on the arm and inflated 20 mmHg above systolic BP and maintained for 2 min then rapidly deflated. All measurements were made in a quiet room with a patient in the supine position. The maximal reactive hyperemia was measured after cuff deflation, which allows measurement of the right forearm postischemic skin reactive hyperemia (SRH).|Week 38|Intent-to-treat. The intent to treat population is defined as those who provide a baseline measure and at least one post-baseline measurement (not necessarily an endpoint measure)||Perfusion units||Standard Error|Least Squares Mean
711368|NCT00171054|Secondary|Change From Baseline in Post-ischemic Forearm Skin Reactive Hyperemia at Week 12|Cutaneous blood flow was continuously recorded by a laser Doppler flowmeter. The laser Doppler flow probe was applied on the volar part of the right forearm with a plastic holder 10 cm proximal to the wrist. All measurements were made with a pressure cuff on the arm and inflated 20 mmHg above systolic BP and maintained for 2 min then rapidly deflated. All measurements were made in a quiet room with a patient in the supine position. The maximal reactive hyperemia was measured after cuff deflation, which allows measurement of the right forearm postischemic skin reactive hyperemia (SRH).|Baseline and Week 12|Intent-to-treat. The intent to treat population is defined as those who provide a baseline measure and at least one post-baseline measurement (not necessarily an endpoint measure)||Perfusion units||Standard Error|Least Squares Mean
711369|NCT00171054|Primary|Change From Baseline to Week 38 in the Carotid-femoral Pulse Wave Velocity (PWV)|PWV was determined from transcutaneous Doppler flow recordings and the foot-to-foot method triggered by the simultaneous ECG. Two simultaneous Doppler flow tracings were taken at the left common carotid and the right femoral artery in the groin with a linear array probe. The time delay (t) was measured between R wave of the ECG and the base of the flow waves recorded at these points, and averaged over 10 beats. The distance (D) traveled by the pulse wave was measured over body surface as the distance from the suprasternal notch to the carotid artery. PWV was calculated as PWV=D/t.|Baseline and Week 38|Intent-to-treat. The intent to treat population is defined as those who provide a baseline measure and at least one post-baseline measurement (not necessarily an endpoint measure)||m/s||Standard Error|Least Squares Mean
711370|NCT00171210|Secondary|Change of Total Body Iron Excretion Rate (TBIE) From Start of ICL670 Treatment to the End of Study|Median change in TBIE (mg/kg/day) from start of treatment with Deferasirox (ICL670) to end of study.|Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years)|All patients enrolled into core study and who consented to participate in extension contributed to the pool of data on long term safety follow-up. Analyses included all patients who received at least 1 dose of ICL670 in the core/extension study, that is, analyses also included ICL670 patients from the core group who did not continue into extension.||mg/kg/day||Full Range|Median
711371|NCT00171210|Secondary|Relative Change in Liver Iron Content From Start of ICL670 Treatment to End of Study as Measured by SQUID|Relative change in liver iron content (LIC) measured by Superconducting Quantum Interfering Device (SQUID), calculated by: End of study value - Start of ICL670 treatment value (absolute change) / Start of ICL670 treatment value.|Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years)|Population includes only those participants from the full analysis set (defined as all participants who received at least 1 dose of ICL670 in the core/extension study, that is, analyses also included ICL670 participants from the core group who did not continue into extension) and had LIC SQUID data at Start of ICL670 treatment and End of Study.||percent of start value||Full Range|Median
711372|NCT00171210|Secondary|Absolute Change in Liver Iron Content From Start of ICL670 Treatment to End of Study Measured by SQUID|Measurement of the median absolute change in liver iron content (LIC) from start of treatment with Deferasirox (ICL670) to end of study obtained through Superconducting Quantum Interfering Device (SQUID). Absolute change = End of study value - start of treatment value. LIC is expressed in mg of iron per gram of liver dry weight (mg Fe/g dw).|Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years)|Population includes only those participants from the full analysis set (defined as all participants who received at least 1 dose of ICL670 in the core/extension study, that is, analyses also included ICL670 participants from the core group who did not continue into extension) and had LIC SQUID data at Start of ICL670 treatment and End of Study.||mg Fe/g dw||Full Range|Median
711373|NCT00171210|Secondary|Relative Change in Liver Iron Content From Start of ICL670 Treatment to End of Study Measured by Biopsy|Relative change in liver iron content (LIC) as measured by biopsy and calculated by: End of study value - Start of ICL670 treatment value (absolute change) / Start of ICL670 treatment value.|Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years)|Population includes only those participants from the full analysis set (defined as all participants who received at least 1 dose of ICL670 in the core/extension study, that is, analyses also included ICL670 participants from the core group who did not continue into extension) and had LIC Biopsy data at Start of ICL670 treatment and End of Study.||percent of start value||Full Range|Median
711374|NCT00171210|Secondary|Absolute Change in Liver Iron Content From Start of ICL670 Treatment to End of Study Measured by Biopsy|Measurement of median absolute change in liver iron content (LIC) from start of treatment with Deferasirox (ICL670) to end of study obtained through biopsy. Absolute change = End of study value - start of treatment value. LIC is expressed in mg of iron per gram of liver dry weight (mg Fe/g dw).|Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years)|Population includes only those participants from the full analysis set (defined as all participants who received at least 1 dose of ICL670 in the core/extension study, that is, analyses also included ICL670 participants from the core group who did not continue into extension) and had LIC Biopsy data at Start of ICL670 treatment and End of Study.||mg Fe/g dw||Full Range|Median
711375|NCT00171210|Secondary|Change in Surrogate Marker: Transferrin Saturation From Start of Treatment With ICL670 to End of Study|"Measurement of the relative change of potential surrogate marker: Transferrin Saturation (Percent) from start of treatment with Deferasirox (ICL670) to end of study.
(Transferrin Saturation at the End of Study-Tranferrin Saturation at Start of ICL670)/Transferrin Saturation at Start of ICL670*100."|Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years)|All patients enrolled into core study and who consented to participate in extension contributed to the pool of data on long term safety follow-up. Analyses included all patients who received at least 1 dose of ICL670 in the core/extension study, that is, analyses also included ICL670 patients from the core group who did not continue into extension.||Percent change||Standard Deviation|Mean
711376|NCT00171210|Secondary|Change in Surrogate Marker: Serum Iron From Start of Treatment With ICL670 to End of Study|"Measurement of the relative change of potential surrogate markers: Serum Iron (µmol/L) from start of treatment with Deferasirox (ICL670) to end of study.
(Serum Iron at the End of Study-Serum Iron at Start of ICL670)/Serum Iron at Start of ICL670*100."|Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years)|All patients enrolled into core study and who consented to participate in extension contributed to the pool of data on long term safety follow-up. Analyses included all patients who received at least 1 dose of ICL670 in the core/extension study, that is, analyses also included ICL670 patients from the core group who did not continue into extension.||Percent change||Standard Deviation|Mean
711377|NCT00171210|Secondary|Change in Surrogate Marker: Serum Transferrin From Start of Treatment With ICL670 to End of Study|"Measurement of the relative change in percent of potential surrogate marker: Serum Transferrin (g/L) from start of treatment with Deferasirox (ICL670) to end of study.
(Serum Transferrin at the End of Study-Serum Transferrin at Start of ICL670)/Serum Transferrin at Start of ICL670*100."|Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years)|All patients enrolled into core study and who consented to participate in extension contributed to the pool of data on long term safety follow-up. Analyses included all patients who received at least 1 dose of ICL670 in the core/extension study, that is, analyses also included ICL670 patients from the core group who did not continue into extension.||Percent change||Standard Deviation|Mean
711378|NCT00171210|Secondary|Long-term Effect of Treatment With ICL670 on the Changes in Serum Ferritin Levels From Start of ICL670 Treatment to End of Study|Mean Absolute Change in serum ferritin (ug/L) from start of treatment with Deferasirox (ICL670) to end of study taking into account the therapeutic goal which will either be to maintain iron balance or to induce negative iron balance. End of study taken as the mean of, at most, the last three available results after start of treatment with ICL670.|Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years)|All patients enrolled into core study and who consented to participate in extension contributed to the pool of data on long term safety follow-up. Analyses included all patients who received at least 1 dose of ICL670 in the core/extension study, that is, analyses also included ICL670 patients from the core group who did not continue into extension.||μg/L||Standard Deviation|Mean
711379|NCT00171210|Secondary|Long-term Effect of ICL670 on Hepatic Iron Stores Measured by Means of Liver Iron Content (LIC) as Assessed by SQUID|Mean absolute change in LIC from start of Deferasirox (ICL670) treatment to the end of the study assessed by Superconducting Quantum Interfering Device (SQUID) measurement used as a non-invasive alternative to Biopsy for pediatric participants. Reported in milligrams of Iron per gram dry weight (mg Fe/g dw).|Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years)|Population includes only those participants from the full analysis set (defined as all participants who received at least 1 dose of ICL670 in the core/extension study, that is, analyses also included ICL670 participants from the core group who did not continue into extension) and had LIC SQUID data at Start of ICL670 treatment and End of Study.||mg Fe/g dw||Standard Deviation|Mean
711380|NCT00171210|Secondary|Long-term Effect of ICL670 on Hepatic Iron Stores Measured by Means of Liver Iron Content (LIC) as Assessed by Liver Biopsy|Mean absolute change of LIC from start of Deferasirox (ICL670) treatment to the end of study assessed by liver biopsy. Reported in milligrams of Iron per gram dry weight (mg Fe/g dw).|Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years)|Population includes only those participants from the full analysis set (defined as all participants who received at least 1 dose of ICL670 in the core/extension study, that is, analyses also included ICL670 participants from the core group who did not continue into extension) and had LIC Biopsy data at Start of ICL670 treatment and End of Study.||mg Fe/g dw||Standard Deviation|Mean
711381|NCT00171210|Primary|Long Term Safety and Tolerability Profile of ICL670 Based on the Number of Participants Who Experienced Any Adverse Event|Adverse events results are based on preferred terms with at least 7% of participants in any group.|up to 5 years|All patients enrolled into core study and who consented to participate in extension contributed to the pool of data on long term safety follow-up. Analyses included all patients who received at least 1 dose of ICL670 in the core/extension study, that is, analyses also included ICL670 patients from the core group who did not continue into extension.||Participants|||Number
711382|NCT00171301|Secondary|Absolute Change in Serum Ferritin Level for All Participants Measured From Core Study Baseline (BL) to End of Extension Study, by Baseline Liver Iron Content (LIC)|Serum Levels were assessed at core study baseline (BL) and then 1 year and 2 years in core study, baseline of extension study and time of discontinuation from the extension visit (end of study). Serum Ferritin is reported in micrograms per Liter. Absolute change in Serum Ferritin from core study baseline to the end of the extension study is presented for participants with the following two core study baseline LIC levels: 1-<7 mg Fe/g dw and ≥7 mg Fe/g dw.|From Baseline of Core Study to End of Extension Study, up to 3 years|Participants from the Intent-to-Treat (ITT) population for whom Serum Ferritin data was available at Core Study baseline and at the End of Extension Study. “n” is the number of participants analyzed in each category.||µg/L||Standard Deviation|Mean
711383|NCT00171301|Secondary|Absolute Change in Serum Ferritin Level Measured From Core Study Baseline (BL) to End of Extension Study|Serum Levels were assessed at core study baseline (BL), 1 year, 2 years in core study, baseline of extension study and time of discontinuation from the extension visit (end of study) in monthly intervals. Serum Ferritin is reported in micrograms per Liter (µg/L).|From Baseline of Core Study to End of Extension Study, up to 3 years|Participants from the Intent-to-Treat (ITT) population for whom Serum Ferritin data was available at Core Study baseline and at the End of Extension Study.||µg/L||Standard Deviation|Mean
711384|NCT00171301|Primary|Absolute Change in Liver Iron Concentration (LIC)Measured by Liver MRI or Liver Biopsy From Core Study Baseline (BL) to End of Extension Study, by LIC Category|"Liver MRI or Liver Biopsy was performed at the core study baseline (BL) and then 1 year and 2 years in the core study, baseline of the extension study and time of discontinuation from the extension visit (end of study). Liver iron content (LIC) is reported in milligram Iron per gram dry weight (mg Fe/g dw).
Absolute change in LIC from core study baseline to the end of the extension study is presented for participants with the following two core study baseline LIC levels: 1-<7 mg Fe/g dw and ≥7 mg Fe/g dw."|From Baseline of Core Study to End of Extension Study, up to 3 years|Participants from the Intent-to-Treat (ITT) population for whom LIC data was available at Core Study baseline and at the End of Extension Study. “n” is the number of participants analyzed in each category.||mg Fe/g dw||Standard Deviation|Mean
711401|NCT00178477|Primary|Tumor Motion Related to Breathing as Determined From MRI Images|"Determine the typical and maximal tumor 3D displacements over the respiratory cycle and how these values vary depending on the tumor location
Determine the reproducibility of target position over multiple breath-holds
Determine the variability across patients in respiratory-derived lesion motion and target position reproducibility over multiple breath-holds"|20 - 30 seconds|Data were not analyzed due to study termination.|||||
711971|NCT00191334|Secondary|Time to Progressive Disease|Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause.|every other 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up|||weeks||95% Confidence Interval|Median
711385|NCT00171301|Primary|Percentage of Participants With Treatment Success From Core Baseline (BL) to Extension End of Study, by Baseline LIC Level and Age|Success was defined as the percentage of participants with decreased liver iron content (LIC) at the end of extension study compared to core baseline (BL) LIC. Success Criteria: For participants with Baseline LIC from 1 - <7 mg Fe/g dw, success was achieved if LIC level maintained at 1 - <7 mg Fe/g dw. For participants with Baseline LIC ≥7 - <10 mg Fe/g dw, success was achieved if LIC dropped to between 1 and < 7 mg Fe/g dw. For participants with Baseline LIC ≥10 mg Fe/g dw, success was achieved if LIC dropped by at least 3 mg Fe/g dw. LIC was measured by biopsy or magnetic resonance imaging.|From Core Study Baseline, to Extension End of Study, Up to 3 Years|The primary analysis will be on the intent-to-treat (ITT) population. ITT population includes all participants who performed the core end of study (EOS) visit evaluation and assessments and were included in the extension study. “n” is the number of participants analyzed in each category.||percentage of participants||95% Confidence Interval|Mean
711386|NCT00171314|Secondary|Percentage of Participants With Radiological (Vertebra) Fractures Which Were Not Present at Baseline But Were Present at Year 3|Radiological Fracture at 36 months which was not present at baseline = (new fracture/number participant analyzed)*100. Evaluation of radiological fractures were based on central lab X-ray data. A subject with multiple fractures at the same time or multiple fractures with the same grade is counted only once for that treatment.|Year 3|For the analysis of safety, the safety population for treatment arms were defined by the actual treatment received, rather than the treatment arm assigned by randomization. Participants with observations at Year 3 were included in this analysis.||Percentage of Participants|||Number
711387|NCT00171314|Secondary|Percent Change in Total Hip BMD at Year 1, Year 2, Year 3, Year 4 and Year 5|Bone Mineral Density (BMD)is measured by dual energy x-ray absorptiometry (DXA).Percent Change = [(BMD at Visit - BMD at Baseline) / BMD at Baseline] * 100.|From baseline to Year 1, Year 2, Year 3, Year 4, Year 5|For the analysis of safety, the safety population for treatment arms were defined by the actual treatment received, rather than the treatment arm assigned by randomization. During different time points, participants with observations at that time point were included in the analysis.||Percent Change||Standard Deviation|Mean
711388|NCT00171314|Secondary|Percent Change in Lumbar Spine (L1-L4) BMD at Year 1, Year 2, Year 3, Year 4 and Year 5|Bone Mineral Density (BMD)is measured by dual energy x-ray absorptiometry (DXA).Percent Change = [(BMD at Visit - BMD at Baseline) / BMD at Baseline] * 100.|From Baseline to Year 1, Year 2, Year 3, Year 4, Year 5|For the analysis of safety, the safety population for treatment arms were defined by the actual treatment received, rather than the treatment arm assigned by randomization.||Percent Change||Standard Deviation|Mean
711389|NCT00171314|Secondary|Percent Change in Lumbar Spine (L2-L4) BMD at 2 Years, 3 Years, 4 Years and 5 Years|Bone Mineral Density (BMD)is measured by dual energy x-ray absorptiometry (DXA).Percent Change = [(BMD at Visit - BMD at Baseline) / BMD at Baseline] * 100.|From Baseline to Year 2, Year 3, Year 4, Year 5|"Analysis of safety:safety population for treatment arms were defined by the actual treatment received, rather than the treatment arm assigned by randomization. n in each category indicates participants with data at baseline and each corresponding timepoint."||Percent Change||Standard Deviation|Mean
711390|NCT00171314|Primary|Percent Change in Lumbar Spine (L2-L4) BMD After 12 Months of Letrozole Therapy|Bone Mineral Density (BMD)is measured by dual energy x-ray absorptiometry (DXA).Percent Change = [(BMD at Visit - BMD at Baseline) / BMD at Baseline] * 100.|From Baseline - 12 months|For the analysis of safety, the safety population for treatment arms were defined by the actual treatment received, rather than the treatment arm assigned by randomization. Participants with observations at baseline and 12 months were included in this analysis.||Percent Change||Standard Deviation|Mean
711391|NCT00171340|Secondary|Percentage of Participants With Clinical Fractures at 3 Years of Therapy Which Were Not Present at Baseline|At 3 years of therapy the percentage of participants with fractures as detected by X-ray and/ or bone scan.|Baseline,3 years|The Safety Population consists of all Randomized Patients who received at least 1 dose of study medication.||Percentage of Participants|||Number
711392|NCT00171340|Secondary|Percentage Change in Bone Mineral Density (BMD) of the Total Hip at 12 Months, 2 Years, 3 Years, 4 Years and 5 Years After Therapy.|Bone Mineral Density (g/cm^2) of the Lumbar Spine (L2-L4) as measured by dual energy x-ray absorptiometry (DXA)|Baseline, 12 months. Baseline, 2 years. Baseline, 3 years. Baseline, 4 years. Baseline, 5 years.|The Safety Population consists of all Randomized Patients who received at least 1 dose of study medication. n in each of the categories is the number of participants who had safety data at baseline and the given time point.||Percentage change in BMD||Standard Deviation|Mean
711393|NCT00171340|Secondary|Percentage Change in Bone Mineral Density (BMD)of the Lumbar Spine (L1-L4) Over 5 Years of Therapy.|Bone Mineral Density (g/cm^2) of the Lumbar Spine (L1-L4)as measured by dual energy x-ray absorptiometry (DXA)|Baseline, 5 years.|The Safety Population consists of all Randomized Patients who received at least 1 dose of study medication. n in each of the categories is the number of participants who had safety data at baseline and the given time point.||Percentage change in BMD||Standard Deviation|Mean
711394|NCT00171340|Secondary|Percentage Change in Bone Mineral Density (BMD) of the Lumbar Spine (L2-L4) at 2, 3, 4 and 5 Years of Therapy.|Bone Mineral Density (g/cm^2) of the Lumbar Spine (L2-L4) as measured by dual energy x-ray absorptiometry (DXA)|Baseline, 2 years. Baseline, 3 years. Baseline, 4 years. Baseline, 5 years.|The Safety Population consists of all Randomized Patients who received at least 1 dose of study medication. n in each of the categories is the number of participants who had safety data at baseline and the given time point.||Percentage change in BMD||Standard Deviation|Mean
711395|NCT00171340|Primary|Percentage Change in Bone Mineral Density (BMD) of the Lumbar Spine (L2-L4) at 12 Months of Therapy.|Bone Mineral Density (g/cm^2) of the Lumbar Spine (L2-L4) as measured by energy x-ray absorptiometry (DXA).|Baseline, 12 months|The Safety Population consists of all Randomized Patients who received at least 1 dose of study medication.||Percentage change in BMD||Standard Deviation|Mean
711396|NCT00178256|Secondary|Median Survival|This is median survival for all subjects enrolled.|86 months|||months||Full Range|Median
711397|NCT00178256|Primary|Define the Maximum Tolerated Dose (MTD) Using This Dose Schedule.||5 years|||Percentage subj w dose limiting toxicity|||Number
711398|NCT00178464|Primary|Number of Adverse Events|Occurrence of individual adverse events and relationship to aspirin|12 months|Intention to treat||events|||Number
711402|NCT00178503|Secondary|Mean Conners' Parent ADHD Index T Score by Week|The ADHD Index of the Conners' Parent Rating Scale-Revised (CPRS-R) assesses symptoms associated with ADHD, including inattentiveness, hyperactivity and impulsivity. Lower T-scores on this subscale are associated with milder ADHD symptoms. T-scores have a mean of 50 and a SD of 10. Thus, T-scores of 70+ (i.e., 2 SD's over the mean) on the ADHD Index are suggestive of very significant ADHD symptomatology. Treatment-related changes of 5+ points are considered to be significant.|Measured at each dosing week of the drug trial (placebo, low, medium, high)|||Units on a scale (T-scores)||Standard Deviation|Mean
711403|NCT00178503|Primary|Mean Continuous Performance Test (CPT)-Commission Errors by Dose|CPT is a measure of sustained attention using nonverbal stimuli (pictures). Participants are asked to click on the witch (target), which appears for 25% of the trials. Commission errors are measured by number of times they click for the non-target items.|Measured at each dosing week of the drug trial (placebo, low, medium, high)|||Total Errors||Standard Deviation|Mean
711404|NCT00178503|Primary|Mean Conners' Teacher ADHD Index T Score by Dose|The ADHD Index of the Conners' Teacher Rating Scale-Revised (CTRS-R) assesses symptoms associated with ADHD, including inattentiveness, hyperactivity and impulsivity. Lower T-scores on this subscale are associated with milder ADHD symptoms. T-scores have a mean of 50 and a SD of 10. Thus, T-scores of 70+ (i.e., 2 SD's over the mean) on the ADHD Index are suggestive of very significant ADHD symptomatology. Treatment-related changes of 5+ points are considered to be significant.|Measured at each dosing week of the drug trial (placebo, low, medium, high)|Although there were 24 participants who completed the trial, teacher ratings were only available for 18 participants due to 6 children being seen during the summer months.||Units on a scale (T-scores)||Standard Deviation|Mean
711405|NCT00180271|Secondary|Recurrent Heart Failure Events||Time of event, DSMB review||||||
711406|NCT00180271|Primary|Mortality From Any Cause or First Heart Failure (HF) Event|"MADIT-CRT was an event-driven trial in which patients were monitored for all-cause mortality and HF events. An HF event was defined as either hospitalization for symptoms and/or signs consistent with congestive HF and:
administration of intravenous decongestive therapy that does not involve formal in-patient hospital admission, regardless of the setting (i.e. in an emergency room setting, in the physician’s office, etc.), or
administration of an augmented HF regimen with oral or intravenous medications during an in-hospital stay."|Outcome measured at average follow-up duration of 2.4 years.|Analysis was performed on an intention-to-treat basis.||Participants|||Number
711407|NCT00180323|Secondary|Left Ventricular Ejection Fraction (LVEF)|Left ventricular Ejection Fraction (LVEF) was measured before implant (baseline) and at 3 and 6 months Follow-up|implant (baseline), 3 Months, 6 Months|||% of cardiac volume||Standard Deviation|Mean
711408|NCT00180323|Secondary|6 Minute Walk Test|6 Minute Walk Test was performed at implant (baseline), 3 months and 6 months follow-up Distance walked within 6 minutes is assessed in meter. This is a test that reflects daily life activities of elderly patients.|implant (baseline), 3 months and 6 months Follow-up|||meter||Standard Error|Mean
711409|NCT00180323|Primary|Optimal AV-Delay (AVD)|Optimal AV-Delay will be measured at implant (baseline ), 3months and 6 months Follow-up for intrinsic heart rate, and 10, 20 and 30 Bpm above intrinsic heart rate.|Implant (baseline), 3 months and 6 months Follow-up|||ms||Standard Deviation|Mean
711410|NCT00180323|Primary|Aortic Velocity Time Integral (VTI)|Velocity time integral of the aortic flow correlates with cardiac output and is an accepted parameter for optimization of Cardiac Resynchronization Therapy (CRT).|At implant (baseline), 3 months and 6 months Follow-up|||cm||Standard Deviation|Mean
711411|NCT00180479|Secondary|Ischemia Driven Major Adverse Cardiac Event (MACE)|"The composite endpoint comprised of:
Cardiac death
Myocardial infarction (MI, classified as Q-wave and non-Q wave)
Ischemia-driven target lesion revascularization (TLR) by CABG or PCI"|5 years|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||percentage of participants|||Number
711412|NCT00180479|Secondary|Ischemia Driven Target Vessel Revascularization (ID-TVR)|"Revascularization at the target vessel associated with any of the following
Positive functional ischemia study
Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA
Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study
Derived from Non-Hierarchical Subject Counts of Adverse Events"|5 years|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||percentage of participants|||Number
711413|NCT00180479|Secondary|Ischemia Driven Target Lesion Revascularization (ID-TLR)|"Revascularization @ target lesion associated w/ any of following:
(+) functional ischemia study Ischemic symptoms & angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study"|5 years|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||percentage of participants|||Number
711414|NCT00180479|Secondary|Target Vessel Failure (TVF)|"The composite endpoint comprised of:
Cardiac death (death in which a cardiac cause cannot be excluded)
Myocardial infarction (MI, classified as Q-wave and non-Q wave)
Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
Ischemia-driven target vessel revascularization (TVR) by CABG or PCI"|5 years|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||percentage of participants|||Number
711415|NCT00180479|Secondary|In-segment % Diameter Stenosis (% DS)|Within the margins of the stent, 5 mm proximal and 5 mm distal to the stent, the value calculated as 100 * (1 – in-segment MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.|240 days|Only a certain number of patients were required to have angiographic or IVUS follow-up. The analysis population for these follow-ups may have changed due to patient's not completing an angiographic or IVUS follow-up procedure. Patients may also have missed the follow-up visits due to early termination from the study.||percent of in-segment diameter stenosis||Standard Deviation|Mean
711416|NCT00180479|Secondary|In-stent % Diameter Stenosis (% DS)|In-stent: Within the margins of the stent, the value calculated as 100 * (1 – in-stent MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.|at 240 days|Only a certain number of patients were required to have angiographic or IVUS follow-up. The analysis population for these follow-ups may have changed due to patient's not completing an angiographic or IVUS follow-up procedure. Patients may also have missed the follow-up visits due to early termination from the study.||percent diameter stenosis||Standard Deviation|Mean
711417|NCT00180479|Secondary|% Volume Obstruction (% VO)|Defined as stent intimal hyperplasia and calculated as 100*(Stent Volume - Lumen Volume)/Stent Volume by IVUS.|at 240 days|Only a certain number of patients were required to have angiographic or IVUS follow-up. The analysis population for these follow-ups may have changed due to patient's not completing an angiographic or IVUS follow-up procedure. Patients may also have missed the follow-up visits due to early termination from the study.||percent of volume obstruction||Standard Deviation|Mean
711418|NCT00180479|Secondary|In-stent Late Loss|In-stent MLD post-procedure minus in-stent MLD at follow-up (in-stent defined as within the margins of the stent)|at 240 days|Only a certain number of patients were required to have angiographic or IVUS follow-up. The analysis population for these follow-ups may have changed due to patient's not completing an angiographic or IVUS follow-up procedure. Patients may also have missed the follow-up visits due to early termination from the study.||millimeters||Standard Deviation|Mean
711419|NCT00180479|Secondary|Distal Late Loss|Distal MLD post-procedure minus distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to stent placement)|240 days|Only a certain number of patients were required to have angiographic or IVUS follow-up. The analysis population for these follow-ups may have changed due to patient's not completing an angiographic or IVUS follow-up procedure. Patients may also have missed the follow-up visits due to early termination from the study.||millimeters||Standard Deviation|Mean
711420|NCT00180479|Secondary|Proximal Late Loss|Proximal Minimum Lumen Diameter (MLD) post-procedure minus proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to stent placement)|at 240 days|Only a certain number of patients were required to have angiographic or IVUS follow-up. The analysis population for these follow-ups may have changed due to patient's not completing an angiographic or IVUS follow-up procedure. Patients may also have missed the follow-up visits due to early termination from the study.||millimeters||Standard Deviation|Mean
711421|NCT00180479|Secondary|Acute Success: Clinical Procedure|Successful delivery and deployment of study stent/s @ the intended target lesion and successful withdrawal of the stent delivery system with final residual stenosis < 50%.|In-hospital|||percentage of participants|||Number
711422|NCT00180479|Secondary|Acute Success: Clinical Device|Successful delivery and deployment of 1st implanted study stent/s @ the intended target lesion and successful withdrawal of the stent delivery system with final residual stenosis < 50%.|In-hospital|||percentage of participants|||Number
711423|NCT00180479|Secondary|Persisting Incomplete Stent Apposition, Late-acquired Incomplete Stent Apposition, Aneurysm, Thrombosis, and Persisting Dissection|"Incomplete Apposition (Persisting & Late acquired): Failure to completely appose vessel wall w/ ≥1 strut separated from vessel wall w/ blood behind strut per ultrasound. Aneurysm: Abnormal vessel expansion ≥ 1.5 of reference vessel diameter. Thrombus: Protocol & ARC definition.
Persisting dissection @ follow-up, present post-procedure."|at 240 days|Only a certain number of patients were required to have angiographic or IVUS follow-up. The analysis population for these follow-ups may have changed due to patient's not completing an angiographic or IVUS follow-up procedure. Patients may also have missed the follow-up visits due to early termination from the study.||percentage of participants|||Number
711424|NCT00180479|Secondary|In-segment % Angiographic Binary Restenosis (% ABR) Rate|Percent of subjects with a follow-up in-segment percent diameter stenosis of ≥ 50% per QCA|240 days|Only a certain number of patients were required to have angiographic or IVUS follow-up. The analysis population for these follow-ups may have changed due to patient's not completing an angiographic or IVUS follow-up procedure. Patients may also have missed the follow-up visits due to early termination from the study.||percentage of participants|||Number
711425|NCT00180479|Secondary|In-stent % Angiographic Binary Restenosis (% ABR) Rate|Percent of subjects with a follow-up in-stent percent diameter stenosis of ≥ 50% per quantitative coronary angiography (QCA)|at 240 days|Only a certain number of patients were required to have angiographic or IVUS follow-up. The analysis population for these follow-ups may have changed due to patient's not completing an angiographic or IVUS follow-up procedure. Patients may also have missed the follow-up visits due to early termination from the study.||percentage of participants|||Number
711426|NCT00180479|Secondary|Ischemia Driven Major Adverse Cardiac Event (MACE)|"The composite endpoint comprised of:
Cardiac death
Myocardial infarction (MI, classified as Q-wave and non-Q wave)
Ischemia-driven target lesion revascularization (TLR) by CABG or PCI"|4 year|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||percentage of participants|||Number
711427|NCT00180479|Secondary|Ischemia Driven Major Adverse Cardiac Event (MACE)|"The composite endpoint comprised of:
Cardiac death
Myocardial infarction (MI, classified as Q-wave and non-Q wave)
Ischemia-driven target lesion revascularization (TLR) by CABG or PCI"|3 year|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||percentage of participants|||Number
711428|NCT00180479|Secondary|Ischemia Driven Major Adverse Cardiac Event(MACE)|"The composite endpoint comprised of:
Cardiac death
Myocardial infarction (MI, classified as Q-wave and non-Q wave)
Ischemia-driven target lesion revascularization (TLR) by CABG or PCI"|2 years|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||percentage of participants|||Number
711670|NCT00185458|Secondary|Progestogenic Symptom 7: Hair Loss (as Measured by a VAS)|Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.|Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase|ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.||score on a scale||Standard Deviation|Mean
711429|NCT00180479|Secondary|Ischemia Driven Major Adverse Cardiac Event (MACE)|"The composite endpoint comprised of:
Cardiac death
Myocardial infarction (MI, classified as Q-wave and non-Q wave)
Ischemia-driven target lesion revascularization (TLR) by CABG or PCI"|1 year|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||percentage of participants|||Number
711430|NCT00180479|Secondary|Ischemia Driven Major Adverse Cardiac Event (MACE)|"The composite endpoint comprised of:
Cardiac death
Myocardial infarction (MI, classified as Q-wave and non-Q wave)
Ischemia-driven target lesion revascularization (TLR) by CABG or PCI"|270 days|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||percentage of participants|||Number
711431|NCT00180479|Secondary|Ischemia Driven Major Adverse Cardiac Event (MACE)|"The composite endpoint comprised of:
Cardiac death
Myocardial infarction (MI, classified as Q-wave and non-Q wave)
Ischemia-driven target lesion revascularization (TLR) by CABG or PCI"|180 days|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||percentage of participants|||Number
711432|NCT00180479|Secondary|Ischemia Driven Major Adverse Cardiac Event (MACE)|"The composite endpoint comprised of:
Cardiac death
Myocardial infarction (MI, classified as Q-wave and non-Q wave)
Ischemia-driven target lesion revascularization (TLR) by CABG or PCI"|30 days|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||percentage of participants|||Number
711433|NCT00180479|Secondary|Ischemia Driven Target Vessel Revascularization (ID-TVR)|"Revascularization at the target vessel associated with any of the following
Positive functional ischemia study
Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA
Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study
Derived from Non-Hierarchical Subject Counts of Adverse Events"|4 years|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||percentage of participants|||Number
711434|NCT00180479|Secondary|Ischemia Driven Target Vessel Revascularization (ID-TVR)|"Revascularization at the target vessel associated with any of the following
Positive functional ischemia study
Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA
Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study
Derived from Non-Hierarchical Subject Counts of Adverse Events"|3 years|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||percentage of participants|||Number
711435|NCT00180479|Secondary|Ischemia Driven Target Vessel Revascularization (ID-TVR)|"Revascularization at the target vessel associated with any of the following
Positive functional ischemia study
Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA
Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study
Derived from Non-Hierarchical Subject Counts of Adverse Events"|2 years|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||percentage of participants|||Number
711436|NCT00180479|Secondary|Ischemia Driven Target Vessel Revascularization (ID-TVR)|"Revascularization at the target vessel associated with any of the following
Positive functional ischemia study
Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA
Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study
Derived from Non-Hierarchical Subject Counts of Adverse Events"|1 year|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||percentage of participants|||Number
711437|NCT00180479|Secondary|Ischemia Driven Target Vessel Revascularization (ID-TVR)|"Revascularization at the target vessel associated with any of the following
Positive functional ischemia study
Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA
Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study
Derived from Non-Hierarchical Subject Counts of Adverse Events"|270 days|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||percentage of participants|||Number
711438|NCT00180479|Secondary|Ischemia Driven Target Vessel Revascularization (ID-TVR)|"Revascularization at the target vessel associated with any of the following
Positive functional ischemia study
Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA
Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study
Derived from Non-Hierarchical Subject Counts of Adverse Events"|180 days|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||percentage of participants|||Number
711449|NCT00180479|Secondary|Target Vessel Failure (TVF)|"The composite endpoint comprised of:
Cardiac death (death in which a cardiac cause cannot be excluded)
Myocardial infarction (MI, classified as Q-wave and non-Q wave)
Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
Ischemia-driven target vessel revascularization (TVR) by CABG or PCI"|2 year|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||percentage of participants|||Number
711439|NCT00180479|Secondary|Ischemia Driven Target Vessel Revascularization (ID-TVR)|"Revascularization at the target vessel associated with any of the following
Positive functional ischemia study
Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA
Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study
Derived from Non-Hierarchical Subject Counts of Adverse Events"|30 days|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||percentage of participants|||Number
711440|NCT00180479|Secondary|Ischemia Driven Target Lesion Revascularization (ID-TLR)|"Revascularization @ target lesion associated w/ any of following:
(+) functional ischemia study Ischemic symptoms & angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study"|4 year|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||percentage of participants|||Number
711441|NCT00180479|Secondary|Ischemia Driven Target Lesion Revascularization (ID-TLR)|"Revascularization @ target lesion associated w/ any of following:
(+) functional ischemia study Ischemic symptoms & angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study"|3 year|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||percentage of participants|||Number
711442|NCT00180479|Secondary|Ischemia Driven Target Lesion Revascularization (ID-TLR)|"Revascularization @ target lesion associated w/ any of following:
(+) functional ischemia study Ischemic symptoms & angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study"|2 years|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||percentage of participants|||Number
711443|NCT00180479|Secondary|Ischemia Driven Target Lesion Revascularization (ID-TLR)|"Revascularization @ target lesion associated w/ any of following:
(+) functional ischemia study Ischemic symptoms & angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study"|1 years|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||percentage of participants|||Number
711444|NCT00180479|Secondary|Ischemia Driven Target Lesion Revascularization (ID-TLR)|"Revascularization @ target lesion associated w/ any of following:
(+) functional ischemia study Ischemic symptoms & angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study"|270 days|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||percentage of participants|||Number
711445|NCT00180479|Secondary|Ischemia Driven Target Lesion Revascularization (ID-TLR)|"Revascularization @ target lesion associated w/ any of following:
(+) functional ischemia study Ischemic symptoms & angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study"|180 days|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||percentage of participants|||Number
711446|NCT00180479|Secondary|Ischemia Driven Target Lesion Revascularization (ID-TLR)|"Revascularization @ target lesion associated w/ any of following:
(+) functional ischemia study Ischemic symptoms & angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study"|30 days|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||percentage of participants|||Number
711447|NCT00180479|Secondary|Target Vessel Failure (TVF)|"The composite endpoint comprised of:
Cardiac death (death in which a cardiac cause cannot be excluded)
Myocardial infarction (MI, classified as Q-wave and non-Q wave)
Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
Ischemia-driven target vessel revascularization (TVR) by CABG or PCI"|4 year|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||percentage of participants|||Number
711448|NCT00180479|Secondary|Target Vessel Failure (TVF)|"The composite endpoint comprised of:
Cardiac death (death in which a cardiac cause cannot be excluded)
Myocardial infarction (MI, classified as Q-wave and non-Q wave)
Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
Ischemia-driven target vessel revascularization (TVR) by CABG or PCI"|3 year|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||percentage of participants|||Number
711717|NCT00178633|Secondary|Change in Glucose|Change in glucose. Negative values represent a decrease in glucose levels.|0-9 Months|broken out into 0-3months and 3-9months below||mg/dL||95% Confidence Interval|Mean
711718|NCT00178633|Primary|Change in Weight|Change in weight. Negative values represent weight loss.|0 to 9 months|broken out into 0-3months and 3-9months below||kg||95% Confidence Interval|Mean
711450|NCT00180479|Secondary|Target Vessel Failure (TVF)|"The composite endpoint comprised of:
Cardiac death (death in which a cardiac cause cannot be excluded)
Myocardial infarction (MI, classified as Q-wave and non-Q wave)
Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
Ischemia-driven target vessel revascularization (TVR) by CABG or PCI"|1 year|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||percentage of participants|||Number
711451|NCT00180479|Secondary|Target Vessel Failure (TVF)|"The composite endpoint comprised of:
Cardiac death (death in which a cardiac cause cannot be excluded)
Myocardial infarction (MI, classified as Q-wave and non-Q wave)
Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
Ischemia-driven target vessel revascularization (TVR) by CABG or PCI"|180 days|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||percentage of participants|||Number
711452|NCT00180479|Secondary|Target Vessel Failure (TVF)|"The composite endpoint comprised of:
Cardiac death (death in which a cardiac cause cannot be excluded)
Myocardial infarction (MI, classified as Q-wave and non-Q wave)
Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
Ischemia-driven target vessel revascularization (TVR) by CABG or PCI"|30 days|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||percentage of participants|||Number
711453|NCT00180479|Secondary|Major Secondary Endpoint: Ischemia Driven Target Vessel Failure (ID-TVF)|"The composite endpoint comprised of:
Cardiac death (death in which a cardiac cause cannot be excluded)
Myocardial infarction (MI, classified as Q-wave and non-Q wave)
Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
Ischemia-driven target vessel revascularization (TVR) by CABG or PCI"|270 days|All patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
711454|NCT00180479|Primary|Primary Endpoint: In-segment Late Loss (LL)|In-segment minimal lumen diameter (MLD) post-procedure minus (–) in segment MLD at 240 day follow-up and 5 mm proximal and 5mm distal to the stent equals Late Loss. MLD defined: The average of two orthogonal views (when possible) of the narrowest point within the area of assessment.|240 days|Only a certain number of patients were required to have angiographic follow-up to provide this endpoint information.||millimeters||Standard Deviation|Mean
711455|NCT00180687|Secondary|Postoperative Morphine Use|The reduction in cost comes from reducing the use of opioid which requires nursing supervision and also special pump to be delivered as in the cases of patient controlled analgesia. With that reduction, there will be a reduction in opioid related adverse events that mandate medical or nursing attention and prolong hospitalization, these adverse events include nausea and vomiting, delay mobilization due to drowsiness and alter mental status caused by opioid usage. For these reasons we are collecting data related to these adverse events|24 Hoiurs|||mg||Full Range|Mean
711456|NCT00180687|Secondary|Hours Needed for Safe Mobilization|Drowsiness and delayed mobilization are known adverse effect of opioids usage. By reducing the use of opioids we can reduce or abolish these side effect which will enhance early patient recovery and discharge and reduce hospital cost. We will measure how many hours will take the patient to mobilize freely and safely and correlate them with opioids use.|24 Hours|||Hours needed for safe mobilization||Full Range|Mean
711457|NCT00180687|Secondary|Number of Vomiting / Nausea Episodes|Nausea and vomiting are known adverse effect of opioids usage. By reducing the use of opioids we can reduce or abolish these side effect which will enhance early patient recovery and discharge and reduce hospital cost. We will measure the number of episodes when the patient suffers from these side effect and correlate them with opioids use.|24 hours|||Number of vomitting / Nausea episodes||Full Range|Mean
711458|NCT00180687|Primary|Reduction in Postoperative Pain|Postoperative pain was measured using Pain scale 0-10 (0 = No Pain, 10 = Maximum pain). A trained nursing staff will ask the patient about his / her pain and document that correctly in the chart. The staff will also document if the patient requires any analgesia, the type and the dose.|0 hours, 6 hours, 12 hours, 24 hours|||units on a scale||Full Range|Mean
711459|NCT00181155|Secondary|Cardiac PCr/ATP Post Intravenous Infusion|The mean ratio of creatine phosphate (PCr) to ATP in the heart. This measure, as a ratio, is unitless.|acute (within 15 minutes of single infusion)|Data were analyzed for all participants who completed the MRS per protocol.||ratio||Standard Deviation|Mean
711460|NCT00181155|Primary|Myocardial CK Flux Post Intravenous Allopurinol Infusion.|The mean rate of adenosine triphosphate (ATP) flux through the creatine kinase reaction in the heart.|acute (within 15 minutes of single infusion)|Data were analyzed for all participants who completed the MRS per protocol.||umol/g/sec||Standard Deviation|Mean
711461|NCT00181155|Secondary|Cardiac PCr/ATP Pre Intravenous Infusion|The mean ratio of creatine phosphate (PCr) to ATP in the heart. This measure, as a ratio, is unitless.|Onset of image acquisition.|Data were analyzed for all participants who completed the MRS per protocol.||ratio||Standard Deviation|Mean
711462|NCT00181155|Primary|Myocardial Creatine Kinase (CK) Flux Pre Intravenous Allopurinol Infusion|Magnetic resonance spectroscopy (MRS) Measurement of Myocardial CK Flux Pre Intravenous Allopurinol Infusion|Onset of imaging acquisition.|Data were analyzed for all participants who completed the MRS per protocol.||umol/g/sec||Standard Deviation|Mean
711463|NCT00181610|Secondary|Breast Milk Prolactin Levels and Content||7 days||||||
711464|NCT00181610|Secondary|Breast Milk Volume||7 days||||||
711465|NCT00181610|Primary|Breast Milk Production||7 days|||% change from baseline||Standard Error|Mean
711466|NCT00181623|Secondary|Breast Milk Prolactin Levels and Content|Treatment group|28 days||||||
711467|NCT00181623|Secondary|Breast Milk Volume|Treatment group|28 days||||||
711468|NCT00181623|Primary|Breast Milk Production|Treatment group|28 days|One subject did not qualify after screening.||mL/day||Standard Error|Mean
711469|NCT00181714|Primary|Cigarette Smoking|Cigarette smoking was assessed by youth self report using a modified version of the Fagerstrom Tolerance Questionnaire (FTQ)|24 months|Clinical trial subjects included in this analysis included those adolescents who took at least one dose of OROS MPH following baseline assessment (N=154), with the last observation carried forward (LOCF) for subjects who did not complete the full study schedule of 24 months||percent|||Number
711470|NCT00181766|Primary|The Adult AISRS|The Adult AISRS was used to assess each of the 18 individual criteria symptoms (both inattentive and hyperactive) of ADHD in DSMIV on a severity grid (0=not present; 3=severe; minimum score=0; maximum score=54). Results are given as average change (reduction) in AISRS symptoms from baseline to Week 6.|baseline and 6 Weeks|All analyses were intention to treat (ITT) with the last observation carried forward (LOCF) for subjects who did not complete the full study schedule. Baseline and endpoint AISRS scores were compared used paired t-tests. Statistical significance was determined at alpha level 0.05.||scores on a scale||Standard Deviation|Mean
711471|NCT00181766|Primary|ADHD-Clinical Global Impression|The CGI includes Global Severity (1=not ill; 7=extremely ill) and the Global Improvement (1=very much improved; 7=very much worse) Scales. Overall severity and change in severity of ADHD was assessed with the Clinical Global Impression Scale (CGI). Improvement was defined by CGI-I ≤2, much or very much improved, at study endpoint. Results are given as number of subjects who improved according to the CGI-I using the definition above.|6 Weeks|All analyses were intention to treat (ITT) with the last observation carried forward (LOCF) for subjects who did not complete the full study schedule.||subjects|||Number
711472|NCT00181844|Primary|Change of Mania Symptoms Assessed by Young Mania Rating Scale (YMRS)|Mean reduction in YMRS score at endpoint/LOCF. This is a scale to measure symptoms of mania in children and adolescents. 11 items are rated from 0-4 (7 items) or 0-8 (4 items). The minimum (least severe) total score is 0, and maximum (most severe) total score is 60.|baseline to 12 weeks|||Units on a scale||Standard Deviation|Mean
711473|NCT00181883|Primary|Change in Bipolar Symptoms as Measured by Reduction in Young-Mania Rating Scale (Y-MRS) Total Score|The Y-MRS is used to evaluate mania symptoms in children and adolescents. Items on the scale are rated from 0-4 or 0-8, with higher values indicating greater severity. The minimum (least severe) total score is 0, with the maximum (most severe) score is 60.|Baseline to 8 weeks|||Units on a scale||Standard Deviation|Mean
711474|NCT00182000|Secondary|Disability Inventory||Post-treatment (week 5)||||||
711475|NCT00182000|Secondary|Short-Form Health Survey (SF-36)||Post-treatment (week 5)||||||
711476|NCT00182000|Secondary|Obsessional Beliefs Questionnaire (OBQ)||Post-treatment (week 5)||||||
711477|NCT00182000|Secondary|Beck Anxiety Inventory (BAI)||Post-treatment (week 5)||||||
711478|NCT00182000|Secondary|Beck Depression Inventory (BDI)||Post-treatment (week 5)||||||
711479|NCT00182000|Secondary|Clinical Global Impressions Scale (CGI)||Post-treatment (week 5)||||||
711480|NCT00182000|Primary|Yale-Brown Obsessive Compulsive Scale (YBOCS)|A clinician-rated measure of obsessive-compulsive disorder severity. Each item is scored on a 0 to 4 range. Total scores are obtained by summing items 1-10 and thus range from 0 to 40 with higher scores indicating greater symptom severity. Results posted below are from the post-treatment evaluation (after 10 treatment sessions).|Post-treatment (week 5)|Thirty-three participants were enrolled. Four participants decided not to participate in between enrolling and beginning treatment. Six participants withdrew from the study before the mid-treatment evaluation; 1 participant withdrew from the study after the mid-treatment evaluation, and this participant's data was carried forward.||units on a scale||Standard Deviation|Mean
711481|NCT00182078|Primary|Diagnostic Interview for Children and Adolescents (DICA) - Child|The DICA is a semi-structured interview, and was used to measure Post Traumatic Stress Disorder (PTSD) symptoms in children. The DICA was administered to children who were English-speaking. A minimum total score of 7 and a maximum total score of 18 is required to meet criteria for PTSD. A higher score is indicative of increased PTSD symptoms. Changes in scores from Baseline to Week 24 were examined.|Baseline to Week 24|Intention to treat (ITT). Analysis was conducted on participants with available data.||units on a scale||Standard Deviation|Mean
711482|NCT00182078|Secondary|The Child Depression Inventory (CDI)|The CDI contains 27 items, and measures symptoms of depression in children and adolescents. The CDI ranges in score from 0-54, where higher scores are indicative of a greater number of symptoms. Changes in scores from Baseline to Week 12 were examined.|Baseline to Week 12|Intention to treat (ITT). Analysis was conducted on participants with available data.||units on a scale||Standard Deviation|Mean
711483|NCT00182078|Primary|Diagnostic Interview Schedule for Children and Adolescents (DICA) - Parent|The DICA is a semi-structured interview, and was used to measure post Traumatic Stress Disorder (PTSD) symptoms in children. The DICA was administered to parents who were English-speaking. A minimum total score of 7 and a maximum total score of 18 is required to meet criteria for PTSD. A higher score is indicative of increased PTSD symptoms. Changes in scores from Baseline to Week 24 were examined.|Baseline to Week 24|Intention to treat (ITT). Analysis was conducted on participants with available data.||units on a scale||Standard Deviation|Mean
711484|NCT00182091|Secondary|Change in Visceral Abdominal Adipose Tissue|Change in visceral abdominal adipose tissue in the AcroGHD randomized to Growth Hormone and AcroGHD randomized to Placebo arms. Note that the AcroGHS and Active Acromegaly arms were not interventional arms and thus do not have outcome results.|baseline and 6 months|In the Growth Hormone group, 1 study participant did not complete the study due to discomfort at injection sites. In the Placebo group, data from one study participant was excluded from analysis due to initiation of appetite suppressants to induce weight loss during the study, as prescribed by a physician at a bariatric clinic.||millimeters squared||Standard Deviation|Mean
711485|NCT00182091|Secondary|Change in Total Abdominal Adipose Tissue|Change in total abdominal adipose tissue in the AcroGHD randomized to Growth Hormone and AcroGHD randomized to Placebo arms. Note that the AcroGHS and Active Acromegaly arms were not interventional arms and thus do not have outcome results.|baseline and 6 months|In the Growth Hormone group, 1 study participant did not complete the study due to discomfort at injection sites. In the Placebo group, data from one study participant was excluded from analysis due to initiation of appetite suppressants to induce weight loss during the study, as prescribed by a physician at a bariatric clinic.||millimeters squared||Standard Deviation|Mean
711486|NCT00182091|Secondary|Change in Total Fat Mass|Change in total fat mass in the AcroGHD randomized to Growth Hormone and AcroGHD randomized to Placebo arms. Note that the AcroGHS and Active Acromegaly arms were not interventional arms and thus do not have outcome results.|baseline and 6 months|In the Growth Hormone group, 1 study participant did not complete the study due to discomfort at injection sites. In the Placebo group, data from one study participant was excluded from analysis due to initiation of appetite suppressants to induce weight loss during the study, as prescribed by a physician at a bariatric clinic.||kilograms||Standard Deviation|Mean
711487|NCT00182091|Primary|Change in High-sensitivity C-reactive Protein|Change in high-sensitivity C-reactive protein in the AcroGHD randomized to Growth Hormone and AcroGHD randomized to Placebo arms. Note that the AcroGHS and Active Acromegaly arms were not interventional arms and thus do not have outcome results.|baseline and 6 months|In the Growth Hormone group, 1 study participant did not complete the study due to discomfort at injection sites. In the Placebo group, data from one study participant was excluded from analysis due to initiation of appetite suppressants to induce weight loss during the study, as prescribed by a physician at a bariatric clinic.||mg/liter||Standard Deviation|Mean
711488|NCT00182637|Secondary|Toxicity||2 years|Only two subjects completed the trial. Study closed early due to lack of enrollment. No analysis performed.|||||
711489|NCT00182637|Secondary|Time to Progression||2 years|Only two subjects completed the trial. Study closed early due to lack of enrollment. No analysis performed.|||||
711490|NCT00182637|Primary|Overall Response Rate After 2 Courses of Treatment||2 months|Only two subjects completed the trial. Study closed early due to lack of enrollment. No analysis performed.|||||
711491|NCT00182689|Secondary|Overall Survival|Measured from time of registration to death, or last contact date|0 - 2 years|||months||95% Confidence Interval|Median
711492|NCT00182689|Primary|Objective Response (Confirmed and Unconfirmed, Complete and Partial Responses Per RECIST)|Complete Response (CR) is a complete disappearance of all measurable and non-measurable disease. No new lesions, no disease related symptoms. Normalization of markers and other abnormal lab values. Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration.|8 weeks to 2 years|All eligible patients who received treatment were included in this measure.||percentage of participants||95% Confidence Interval|Number
711493|NCT00182689|Secondary|Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|Patients were assessed for adverse events after completion of every 28-day cycle.|Eligible patients who received any treatment and were assessed for toxicity were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.||Participants with a given type of AE|||Number
711494|NCT00182728|Secondary|Association of Nuclear p53 Expression in Tumor and Normal Tissue Before and After IORT||3 months|No data were collected for this biomarker. Although samples were obtained from patients, they were never processed and analyzed.|||||
711495|NCT00182728|Secondary|Association of Nuclear Factor Kappa-light-chain-enhancer of Activated B Cells (NFkB) Expression in Tumor and Normal Tissue Before and After IORT||3 months|No data were collected for this biomarker. Although samples were obtained from patients, they were never processed and analyzed.|||||
711496|NCT00182728|Secondary|Association of Phosphorylated Epidermal Growth Factor Receptor (EGFR) , Human Epidermal Growth Factor Receptor 2 (HER2), p44/42 Mitogen-activated Protein Kinase (MAPK), and Protein Kinase B (Akt) in Breast Tumors and Normal Tissue Before and After IORT||3 months|No data were collected for any of these biomarkers. Although samples were obtained from patients, they were never processed and analyzed.|||||
711497|NCT00182728|Primary|Ipsilateral Breast Recurrence|Percentage of participants who experienced a ipsilateral breast event (tumor bed recurrence versus elsewhere in breast).|5 years|"There were 71 patients who received IORT. Of those 71 patients, 18 received further local therapy due to high risk pathology. The results include the 53 patients who received IORT without further local therapy."||percentage of participants||95% Confidence Interval|Number
711498|NCT00182728|Primary|Incidence of Grade 3/4 Toxicity|"Skin and subcutaneous toxicity were graded by a radiation oncologist according to the common terminology criteria for adverse events version 3.0. Toxicities directly, probably, or possibly related to the radiation were included. Grade refers to the severity of the AE. The CTCAE v3.0 displays Grades 1 through 5 with unique clinical descriptions of severity for each adverse event (AE) based on this general guideline:
Grade 1 Mild Adverse Event Grade 2 Moderate Adverse Event Grade 3 Severe Adverse Event Grade 4 Life-threatening or disabling Adverse Event Grade 5 Death related to Adverse Event"|3 months|||Participants|||Count of Participants
711499|NCT00182728|Primary|Rates of Good/Excellent Cosmesis as Measured by the Radiation Therapy Oncology Group (RTOG) Cosmetic Rating Scale - Rated by Patients|"Rates of good/excellent cosmesis was evaluated using the following criteria:
Excellent - when compared to the untreated breast, there is minimal or no difference in the size, shape, or texture of the treated breast. There may be mild thickening or scar tissue within the breast or skin, but not enough to change the appearance.
Good – there is mild asymmetry in the size or shape of the treated breast as compared to the normal breast. The thickening or scar tissue within the breast causes only a mild change in the shape."|1 year follow up visit|Patients who received IORT alone. 42 patients assessed their cosmetic outcome.||Participants|||Count of Participants
711500|NCT00182728|Primary|Rates of Good/Excellent Cosmesis as Measured by the Radiation Therapy Oncology Group (RTOG) Cosmetic Rating Scale - Rated by Physician|"Rates of good/excellent cosmesis was evaluated using the following criteria:
Excellent - when compared to the untreated breast, there is minimal or no difference in the size, shape, or texture of the treated breast. There may be mild thickening or scar tissue within the breast or skin, but not enough to change the appearance.
Good – there is mild asymmetry in the size or shape of the treated breast as compared to the normal breast. The thickening or scar tissue within the breast causes only a mild change in the shape."|1 year follow up visit|Patients who received intraoperative radiation therapy (IORT) alone. 56 patients were assessed.||Participants|||Count of Participants
711501|NCT00174382|Secondary|Clinical Global Impressions Improvement (CGI-I) Dichotomized Response|Scale measures subject’s (CGI-I) rated on categorial 7 point Likert scale 1 (very much improved) to 7 (very much worse) with 4 indicating no change from baseline. A dichotomized variable was created: responder = CGI-I score of 4 or less; non-responder = CGI-I score of 5 or more|Baseline, week 24|Full Analysis Set (FAS):all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy. LOCF = Last Observation Carried Forward. Week 24 n=116; Week 24 LOCF n=136||Particpants|||Number
711502|NCT00174382|Secondary|Clinical Global Impressions Improvement (CGI-I)|Scale measures subject’s clinical condition for improvement from baseline (CGI-I)subject rated on 7 point Likert scale from 1(very much improved) to 7(very much worse) & 4 indicates no change from baseline|Week (wk) 24|Full Analysis Set (FAS): all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward. n=number of subjects with value (Week 24 n=116; Week 24 LOCF n=136)||Participants|||Number
711503|NCT00174382|Secondary|Clinical Global Impressions Severity (CGI-S)|Scale measures subject’s clinical condition at baseline for severity (CGI-S) subject rated on numerical scale, 1 (not at all ill) to 7 (most extremely ill).|Baseline|Full Analysis Set (FAS): all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward. n=number of subjects with a value||Participants|||Number
711504|NCT00174382|Secondary|Clinical Global Impressions Severity Score (CGI-S) Clinical Global Impressions Severity Score Improvement(CGI-I)Change From Baseline, Full Analysis Set (FAS)|Scale measures subject’s clinical condition at baseline for severity (CGI-S) & for improvement from baseline (CGI-I). At baseline subject rated on numerical scale, 1 (not at all ill) to 7 (most extremely ill). At follow up subject rated on 7 point Likert scale from 1(very much improved) to 7(very much worse) & 4 indicates no change from baseline|Baseline, week 24|Full Analysis Set (FAS): all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward. Subjects with Baseline = 136; week 24 n = 116; week 24 LOCF n = 136||Score on a scale||Standard Deviation|Mean
711505|NCT00174382|Secondary|Neuropsychiatric Inventory Questionnaire Distress (NPI-Q-D) Score Change From Baseline; Full Analysis Set (FAS)|The total NPI-Q-D score is equal to the sum of all indiviudal symptom distress scale scores with a range of 0 to 60|Baseline, week 12, week 24|Full Analysis Set (FAS): all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward.LOCF n=137; weeks 12, 24 n = 124, 114||Score on a scale||Standard Deviation|Mean
711506|NCT00174382|Secondary|Neuropsychiatric Inventory Questionnaire (NPI-Q) Score Change From Baseline; Full Analysis Set (FAS)|NPI-Q measures severity of behavioural manifestations of dementia & the level of distress each symptom gives the main caregiver, 1 (mild), 3 (severe), 0 if symptom absent, NPI-Q also measures the caregiver distress associated with each symptom,0(no distress)to 5(very severe), total score equals sum of individual item scores & ranges from 0 to 36|Baseline, 12 weeks, 24 weeks|Full Analysis Set (FAS): all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward. LOCF n=137; weeks 12, 24 n = 124, 114||Score on scale||Standard Deviation|Mean
711507|NCT00174382|Secondary|Phonectic Fluency Total Score From Baseline; Full Analysis Set (FAS)|The number of words a particpant can generate in 1 minute.|Baseline, 12 weeks, week 24|Full Analysis Set (FAS): all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward. LOCF n=136; weeks 12, 24 n = 123, 113||score on scale||Standard Deviation|Mean
711508|NCT00174382|Secondary|CLOX Differential Score Change From Baseline; Full Analysis Set (FAS)|CLOX differential score equals the difference between the score for CLOX 2 and the score for CLOX 1, values range from 15 to 0, with 0 indicating perfect executive function, and a worsening with the increasing score.|Baseline, 12 weeks, 24 weeks|Full Analysis Set (FAS): all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward.LOCF N=131; weeks 12, 24 n = 117, 106||Score on a scale||Standard Deviation|Mean
711509|NCT00174382|Secondary|Copied Clock Drawing Test (CLOX 2) Change From Baseline; Full Analysis Set (FAS)|The ability to copy a drawing of a clock. Scored on a scale from 1 to 15; lower scores indicate higher impairment. Change: Mean CLOX 2 score at observation minus mean CLOX 2 score at baseline.|Baseline, 12 weeks, 24 weeks|Full Analysis Set (FAS): all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward. LOCF N=131; weeks 12, 24 n = 117, 106||Score on scale||Standard Deviation|Mean
711510|NCT00174382|Secondary|Free-hand Drawing Test (CLOX 1) Change From Baseline; Full Analysis Set (FAS)|The ability to draw a clock free-hand. Scored on a scale from 1 to 15; lower scores indicate higher impairment. Change: Mean CLOX 1 score at observation minus mean CLOX score at baseline.|Baseline, 12 weeks, 24 weeks|Full Analysis Set (FAS): all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward. N=137; weeks 12, 24 n = 123, 111||Score on a scale||Standard Deviation|Mean
711511|NCT00174382|Secondary|Disability Assessment for Dementia (DAD) Change From Baseline Total Score; Full Analysis Set (FAS)|DAD total score equals total number of questions answered yes multiplied by 100 divided by total number of questions answered.|Baseline, week 12, week 24|Full Analysis Set (FAS):all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward.N=137; Weeks 12, 24 n = 124, 114||score on a scale||Standard Deviation|Mean
711512|NCT00174382|Secondary|Disability Assessment for Dementia Change From Baseline; Instrumental ADL (IADL) Domain.|IADL domain consists of 23 yes-no questions on 6 items (meal preparation, telephoning, going out, finance & correspondence, medications, leisure & housework. Change: Mean IADL score at observation minus mean IADL score at baseline. Total IADL score = number of questions answered yes multiplied by 100 divided by total number of questions answered|Baseline, 12 weeks, 24 weeks|Full Analysis Set (FAS):all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward.N=137; Weeks 12, 24 n= 124,114||score on a scale||Standard Deviation|Mean
711513|NCT00174382|Secondary|Disability Assessment for Dementia Change From Baseline; Activities of Daily Living (ADL) Domain.|The ADL domain includes 17 yes/no questions on four items (hygiene, dressing, continence, eating). Score equals number of questions answered yes multiplied by 100 divided by number of questions answered. Change: Mean ADL score at observation minus mean ADL score at baseline.|Baseline, week 12, week 24|Full Analysis Set (FAS): all subjects who received at least one dose of donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward.N=137; Weeks 12, 24 n= 124, 114.||score on a scale||Standard Deviation|Mean
711514|NCT00174382|Primary|Change in Total Score of Standardized Mini-Mental State Examination (sMMSE); Full Analysis Set|Change from baseline in sMMSE total score. Change: mean total score at observation minus mean total score at baseline. Total score is derived by adding all subscores and ranges from 0 to 30; a higher score indicates a better cognitive state.|Baseline, week 12, week 24|Full Analysis Set (FAS):all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward. N=137; Weeks 12, 24 n=124, 114||Score on a scale||Standard Deviation|Mean
711515|NCT00174447|Primary|Change From Baseline in CGI-S at End of Study (up to 5 Years)|CGI-S Scale: standardized assessment tool to rate severity of subject’s illness; assesses investigator’s impression of subject’s current illness state. Score: 1 (normal - not ill at all) to 7 (among the most extremely ill). Change: score at observation minus score at baseline.|Baseline, up to 5 years (End of Study [LOCF])|ITT. LOCF.||score on a scale||Standard Deviation|Mean
711516|NCT00174447|Primary|Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)|CGI-S Scale: standardized assessment tool to rate severity of subject’s illness; assessed investigator’s impression of subject’s current illness state. Score: 1 (normal - not ill at all) to 7 (among the most extremely ill patients).|Baseline, 3 months, 6 months, 1 year, 3 years, 5 years, End of Study [LOCF]|ITT. LOCF.||participants|||Number
711517|NCT00174447|Secondary|Change From Baseline in Drug Attitude Inventory (DAI) at End of Study (up to 5 Years)|DAI, a 10-item scale to assess how the attitude of schizophrenia patients toward their medications may affect compliance. Respondents indicate 'true' or 'false' for each item. An overall calculated score ranges from -10 to 10, where a positive score indicated a positive subjective response (compliant), whilst a negative score indicated non-compliance. Change: score at observation minus score at baseline.|Baseline, up to 5 years (End of Study)|ITT. n= number of participants with analyzable data.||score on a scale||Standard Deviation|Mean
711518|NCT00174447|Secondary|Number of Participants With Scores on Patient Preference Scale (PPS)|Patient rated satisfaction scale with responses: Much better, I prefer this medication, Slightly better, About the same, Slightly worse, and Much worse, I much preferred my previous medication.|Baseline, up to 5 years (End of Study)|ITT||participants|||Number
711519|NCT00174447|Primary|Change From Baseline in CGI-I at End of Study (up to 5 Years)|CGI-I consists of a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Change from baseline is score at observation minus score at baseline.|Baseline, up to 5 years (End of Study [LOCF])|ITT. LOCF.||score on a scale||Standard Deviation|Mean
711520|NCT00174447|Primary|Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)|CGI-I consists of a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale.|Baseline, 3 months, 6 months, 1 year, 3 years, 5 years, End of Study [LOCF]|Intention to treat (ITT), all patients who received at least one dose of study medication and who have at least one post baseline efficacy evaluation. Imputation at Last Observation Carried Forward (LOCF).||participants|||Number
711521|NCT00174460|Secondary|Growth Curve Comparison Based on Height: Control Arm|Growth curve comparison with height in centimeters as the dependent variable.|Month 36|FAS; Control group received Somatropin from Month 12 onwards. N=number of subjects with evaluable data at observation. Month 36 visit not applicable to Somatropin treatment group.||centimeters||Standard Error|Least Squares Mean
711522|NCT00174460|Secondary|Growth Curve Comparison Based on Height|Growth curve comparison with height in centimeters as the dependent variable.|Month 12, Month 24|FAS; Control group received Somatropin from Month 12 onwards. Data for Month 36 (applicable only to the Control Arm) is reported in a separate outcome measure.||centimeters||Standard Error|Least Squares Mean
711523|NCT00174460|Secondary|Growth Curve Comparison Based on Height SDS: Control Arm|Growth curve comparison with height SDS in centimeters as the dependent variable; SDS = height minus mean (age-and sex-matched reference) divided by SD (age and sex-matched reference). Control Arm final visit=Month 36.|Month 36|FAS; Control group received Somatropin from Month 12 onwards. N=number of subjects with evaluable data at observation. Month 36 visit not applicable to Somatropin treatment group.||centimeters||Standard Error|Least Squares Mean
711524|NCT00174460|Secondary|Growth Curve Comparison Based on Height SDS|Growth curve comparison with height SDS in centimeters as the dependent variable; SDS = height minus mean (age-and sex-matched reference) divided by SD (age and sex-matched reference).|Month 12, Month 24|FAS; Control group received Somatropin from Month 12 onwards. Data for Month 36 (applicable only to the Control Arm) is reported in a separate outcome measure.||centimeters||Standard Error|Least Squares Mean
711525|NCT00174460|Secondary|Number of Participants With Change in Insulin Sensitivity: Control Arm|Insulin sensitivity calculated as incidence of pathological glucose intolerance assessed prior to randomization (Screening Day -3 to Baseline Day 0) and at final visit (final visit: Control Arm=Month 36). Pathological glucose intolerance (oral glucose tolerance test) measured as venous (blood or plasma) with range minimum 120 milligrams per deciliter (mg/dL) to >140 mg/dL; capillary (blood) with range minimum 120 mg/dL to >120 mg/dL; or method not known with range minimum 120 mg/dL to >120 mg/dL.|Baseline, Month 36|FAS; Control group received Somatropin from Month 12 onwards.||participants|||Number
711526|NCT00174460|Secondary|Number of Participants With Change in Insulin Sensitivity: Somatropin|Insulin sensitivity calculated as incidence of pathological glucose intolerance assessed prior to randomization (Screening Day -3 to Baseline Day 0) and at final visit (final visit: Somatropin treatment group=Month 24). Pathological glucose intolerance (oral glucose tolerance test) measured as venous (blood or plasma) with range minimum 120 milligrams per deciliter (mg/dL) to >140 mg/dL; capillary (blood) with range minimum 120 mg/dL to >120 mg/dL; or method not known with range minimum 120 mg/dL to >120 mg/dL.|Baseline, Month 24|FAS||participants|||Number
711550|NCT00174915|Secondary|Change in the Total Number of Tophi at Final Visit in the Subset of Subjects With Palpable Tophi at the Screening Visit|Change in number of tophi/subject was calculated for the subset of subjects with palpable tophi at the Screening. If the tophi were not palpable at the Final Visit, total count was assumed to be 0. The timing of the final visit may have differed for each subject.|Final Visit (up to 28 weeks)|Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug,had a baseline serum urate ≥8.0 mg/dL, and had palpable tophi at the screening visit. Missing data were not imputed.||number of tophi||Inter-Quartile Range|Median
711527|NCT00174460|Secondary|Change From Baseline in Muscle Strength: Hand Grip SDS After 1 Year and After 2 Years|Muscle strength determined by measuring grip force (kilograms) using hand grip dynamometer for participants ≥6 years of age. Baseline and post-baseline SDS values transformed to age and sex specific z-score. Change in hand grip calculated as SDS where SDS = hand grip minus mean (age- and sex-matched reference) divided by SD (age- and sex-matched reference). Positive values are above the average for participant's age and sex; negative values are below the average.|Baseline, Month 12, Month 24|FAS; Control group received Somatropin from Month 12 onwards; (n)=number of participants ≥6 years of age with evaluable data at observation for Somatropin and Control Arm, respectively. SDS reference values used were for the right hand but the hand grip strength measured for this study was for the dominant hand (may not have been the right hand).||z-score||Standard Error|Least Squares Mean
711528|NCT00174460|Secondary|Change From Baseline in Bone Stability Using pQCT After 1 Year and After 2 Years: Strength-strain Index (SSI)|Bone stability expressed as polar SSI in cubic millimeters (mm3). SSI (proximal radius) SDS (number of standard deviations a participant's SSI differs from the average SSI of their age and sex). Baseline and post-baseline SDS values transformed to age and sex specific z-score (Ln(test result/M)]/S); Ln=natural logarithm; M=age- or height-) and sex-specific mean value; S=age-(or height-) and sex-specific coefficient of variation) then change from baseline is calculated. Positive values are above the average for participant’s age and sex; negative values are below the average.|Baseline, Month 12, Month 24|FAS; Control group received Somatropin from Month 12 onwards; (n)=number of participants from FAS with evaluable pQCT data for somatropin and control arm groups, respectively.||z-score||Standard Error|Least Squares Mean
711529|NCT00174460|Secondary|Change From Baseline in Bone Structure Using pQCT After 1 Year and 2 Years: Marrow Area (MA)|Marrow Area measured as millimeters squared (mm2). MA (proximal radius) SDS (number of standard deviations a participant's MA differs from the average MA of their age and sex). Baseline and post-baseline SDS values transformed to age and sex specific z-score (Ln(test result/M)]/S); Ln=natural logarithm; M=age- or height-) and sex-specific mean value; S=age-(or height-) and sex-specific coefficient of variation) then change from baseline is calculated. Positive values are above the average for participant's age and sex; negative values are below the average.|Baseline, Month 12, Month 24|FAS; Control group received Somatropin from Month 12 onwards. Marrow Area was not analyzed as planned.|||||
711530|NCT00174460|Secondary|Change From Baseline in Bone Structure Using pQCT After 1 Year and 2 Years: Cortical Thickness (CT)|Cortical Thickness measured as millimeters (mm). CT (proximal radius) SDS (number of standard deviations a participant's CT differs from the average CT of their age and sex). Baseline and post-baseline SDS values transformed to age and sex specific z-score (Ln(test result/M)]/S); Ln=natural logarithm; M=age- or height-) and sex-specific mean value; S=age-(or height-) and sex-specific coefficient of variation) then change from baseline is calculated. Positive values are above the average for participant’s age and sex; negative values are below the average.|Baseline, Month 12, Month 24|FAS; Control group received Somatropin from Month 12 onwards. Cortical thickness was not analyzed as planned.|||||
711531|NCT00174460|Secondary|Change From Baseline in Bone Structure Using pQCT After 1 Year and 2 Years: Muscle Cross-sectional Area (CSA)|Bone structure Muscle CSA measured as millimeters squared (mm2). CSA (proximal radius) SDS (number of standard deviations a participant's CSA differs from the average CSA of their age and sex). Baseline and post-baseline SDS values transformed to age and sex specific z-score (Ln(test result/M)]/S); Ln=natural logarithm; M=age- or height-) and sex-specific mean value; S=age-(or height-) and sex-specific coefficient of variation) then change from baseline is calculated. Positive values are above the average for participant’s age and sex; negative values are below the average.|Baseline, Month 12, Month 24|FAS; Control group received Somatropin from Month 12 onwards; (n)=number of participants from FAS with evaluable pQCT data for somatropin and control arm groups, respectively.||z-score||Standard Error|Least Squares Mean
711532|NCT00174460|Secondary|Change From Baseline in Bone Structure Using Peripheral Quantitative Computed Tomography (pQCT) After 1 Year and 2 Years: Total Cross-sectional Area (CSA)|Bone structure Total CSA measured as millimeters squared (mm2). Total CSA (proximal radius) SDS (number of standard deviations a participant's CSA differs from the average CSA of their age and sex). Baseline and post-baseline SDS values transformed to age and sex specific z-score (Ln(test result/M)]/S); Ln=natural logarithm; M=age- or height-) and sex-specific mean value; S=age-(or height-) and sex-specific coefficient of variation) then change from baseline is calculated. Positive values are above the average for participant’s age and sex; negative values are below the average.|Baseline, Month 12, Month 24|FAS; Control group received Somatropin from Month 12 onwards; (n)=number of participants from FAS with evaluable pQCT data for somatropin and control arm groups, respectively.||z-score||Standard Error|Least Squares Mean
711533|NCT00174460|Secondary|Change From Baseline in Bone Structure Using pQCT After 1 Year and 2 Years: Cortical Cross-sectional Area (CSA)|Bone structure Cortical CSA measured as millimeters squared (mm2). CSA (proximal radius) SDS (number of standard deviations a participant's CSA differs from the average CSA of their age and sex). Baseline and post-baseline SDS values transformed to age and sex specific z-score (Ln(test result/M)]/S); Ln=natural logarithm; M=age- or height-) and sex-specific mean value; S=age-(or height-) and sex-specific coefficient of variation) then change from baseline is calculated. Positive values are above the average for participant’s age and sex; negative values are below the average.|Baseline, Month 12, Month 24|FAS; Control group received Somatropin from Month 12 onwards; (n)=number of participants from FAS with evaluable pQCT data for somatropin and control arm groups, respectively.||z-score||Standard Error|Least Squares Mean
711534|NCT00174460|Primary|Change in Growth Velocity Standard Deviation Score (SDS) After 1 Year|Change in Growth Velocity (GV) SDS after 1 year where SDS=GV minus mean (age-and sex-matched reference) divided by SD (age and sex-matched reference).|Baseline to 1 year (Month 12)|FAS; Control group received Somatropin from Month 12 onwards.||centimeters per year||Standard Error|Least Squares Mean
711551|NCT00174915|Secondary|Change in the Total Number of Tophi at Week 28 in the Subset of Subjects With Palpable Tophi at the Screening Visit.|Change from baseline at Week 28 in the total number of tophi per subject was calculated for the subset of subjects with palpable tophi at the Screening Visit. If the tophi were not palpable at the Week 28 visit, the total count was assumed to be 0.|Baseline and Week 28|Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug,had a baseline serum urate ≥8.0 mg/dL, and had palpable tophi at the screening visit. Missing data were not imputed.||number of tophi||Inter-Quartile Range|Median
711535|NCT00174460|Secondary|Change From Baseline in Volumetric Cortical Bone Mineral Density (BMD) Using Peripheral Quantitative Computed Tomography (pQCT) After 1 Year and After 2 Years|Volumetric Cortical BMD measured as milligrams per cubic millimeter (mg/mm3). BMD (proximal radius) SDS (number of standard deviations a participant's BMD differs from the average BMD of their age and sex). Baseline and post-baseline SDS values transformed to age and sex specific z-score (Ln(test result/M)]/S); Ln=natural logarithm; M=age- or height-) and sex-specific mean value; S=age-(or height-) and sex-specific coefficient of variation) then change from baseline is calculated. Positive values are above the average for participant’s age and sex; negative values are below the average.|Baseline, Month 12, Month 24|FAS; Control group received Somatropin from Month 12 onwards; (n)=number of participants from FAS with evaluable pQCT data for somatropin and control arm groups, respectively.||z-score||Standard Error|Least Squares Mean
711536|NCT00174460|Secondary|Change From Baseline in Body Composition (Skinfold Thickness) After 1 Year and After 2 Years: Suprailiac|Body composition measured as suprailiac skinfold thickness in millimeters (mm); measured just above the iliac crest in the middle-axillary line.|Baseline, Month 12, Month 24|FAS; Control group received Somatropin from Month 12 onwards. N=number of participants with evaluable data at observation.||millimeters||Standard Error|Least Squares Mean
711537|NCT00174460|Secondary|Change From Baseline in Body Composition (Skinfold Thickness) After 1 Year and After 2 Years: Subscapular|Body composition measured as subscapular skinfold thickness in millimeters (mm); measured laterally just below the angle of the left scapula.|Baseline, Month 12, Month 24|FAS; Control group received Somatropin from Month 12 onwards. N=number of participants with evaluable data at observation.||millimeters||Standard Error|Least Squares Mean
711538|NCT00174460|Secondary|Change From Baseline in Body Composition (Skinfold Thickness) After 1 Year and After 2 Years: Triceps|Body composition measured as skinfold thickness at tricep in millimeters (mm); measured halfway down the left upper arm with arm hanging in relaxed position at participant's side.|Baseline, Month 12, Month 24|FAS; Control group received Somatropin from Month 12 onwards. N=number of participants with evaluable data at observation.||millimeters||Standard Error|Least Squares Mean
711539|NCT00174460|Secondary|Change From Baseline in Height SDS After 2 Years|Change in Height SDS after 2 years (24 months) where SDS = height minus mean (age-and sex-matched reference) divided by SD (age and sex-matched reference).|Baseline, Month 24|FAS; Control group received Somatropin from Month 12 onwards.||centimeters||Standard Error|Least Squares Mean
711540|NCT00174460|Secondary|Change From Baseline in Height After 1 Year and After 2 Years||Baseline, Month 12, Month 24|FAS; Control group received Somatropin from Month 12 onwards.||centimeters||Standard Error|Least Squares Mean
711541|NCT00174460|Secondary|Change From Baseline in Growth Velocity SDS After 2 Years|Change in Growth Velocity SDS after 2 years (24 months) where SDS = growth velocity minus mean (age-and sex-matched reference) divided by SD (age and sex-matched reference).|Baseline, Month 24|FAS; Control group received Somatropin from Month 12 onwards.||centimeters per year||Standard Error|Least Squares Mean
711542|NCT00174460|Secondary|Change From Baseline in Growth Velocity After 1 Year and After 2 Years|Growth velocity measured as centimeters per year.|Baseline, Month 12, Month 24|FAS; Control group received Somatropin from Month 12 onwards.||centimeters per year||Standard Error|Least Squares Mean
711543|NCT00174460|Primary|Change in Height Standard Deviation Score (SDS) After 1 Year|Change in Height SDS after 1 year where SDS=height minus mean (age-and sex-matched reference) divided by SD (age and sex-matched reference).|Baseline to 1 year (Month 12)|Full Analysis Set (FAS; all randomized subjects who had at least 1 post-baseline efficacy measurement); Control group received Somatropin from Month 12 onwards.||centimeters||Standard Error|Least Squares Mean
711544|NCT00174785|Other Pre-specified|Adjudicated Cardiovascular Death|The considered event is cardiovascular death, as assessed by the blinded adjudication of the Steering Committee. The analysis is performed on the time from randomization to this event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.|minimum follow-up duration: 1 year ; maximum: 2.5 years|«All randomized patients» population||participants|||Number
711545|NCT00174785|Secondary|Cardiovascular Death|The considered event is cardiovascular death, as assessed by the Investigator. The analysis is performed on the time from randomization to this event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.|minimum follow-up duration: 1 year ; maximum: 2.5 years|«All randomized patients» population||participants|||Number
711546|NCT00174785|Secondary|First Hospitalization for Cardiovascular Reason|The considered event is the first hospitalization for cardiovascular reason, as assessed by the Investigator. The analysis is performed on the time from randomization to this event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.|minimum follow-up duration: 1 year ; maximum: 2.5 years|«All randomized patients» population||participants|||Number
711547|NCT00174785|Secondary|Death From Any Cause|The considered event is death from any cause. The analysis is performed on the time from randomization to this event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.|minimum follow-up duration: 1 year ; maximum: 2.5 years|«All randomized patients» population||participants|||Number
711548|NCT00174785|Primary|First Hospitalization for Cardiovascular Reason or Death From Any Cause|The primary event is the first hospitalization for cardiovascular reason or death from any cause, whichever is earlier, as assessed by the investigator. The primary efficacy analysis is performed on the time from randomization to this primary event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.|minimum follow-up duration: 1 year ; maximum: 2.5 years|"All efficacy analyses were performed on the all randomized patients population including all patients randomized irrespective of whether the patient actually received any drug or complied with the study protocol."||participants|||Number
711549|NCT00174915|Secondary|Percentage of Subjects Requiring Treatment for a Gout Flare Between Weeks 8 and 28 of the Double-Blind Treatment Period.|Percentage of subjects requiring treatment for a gout flare between Weeks 8 and 28 of the double-blind treatment period was summarized. A subject who reported more than 1 gout flare during this period was counted only once.|Weeks 8 through 28|Analysis was performed on the ITT subjects who had at least one dose of study drug between Weeks 8 and 28.||percentage of subjects|||Number
711628|NCT00184600|Secondary|Number of Participants Having an 'Other' Adverse Event||Up to month 37 (36 months of treatment plus 1 month follow-up)|Safety population consisting of all randomised participants exposed to at least one dose of trial drug(s).||participants|||Number
711552|NCT00174915|Secondary|Percent Change in Primary Tophus Size at Final Visit, as Determined by Physical Measurement in the Subset of Subjects With Palpable Tophi at the Screening Visit.|Percent change in primary tophus size was calculated as [(Final Visit - baseline sizes)/baseline]*100 for the subset of subjects with a primary palpable tophus at Screening. If tophus was not palpable at Final visit, the size was assumed to be 0. The timing of the final visit may have differed for each subject.|Baseline and Final Visit (up to 28 weeks)|Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug, who had a baseline serum urate ≥8.0 mg/dL, and who had a palpable primary tophus measured at baseline. Missing data were not imputed.||percent change from baseline||Inter-Quartile Range|Median
711553|NCT00174915|Secondary|Percent Change in Primary Tophus Size at Week 28, as Determined by Physical Measurement in the Subset of Subjects With Palpable Tophi at the Screening Visit.|The percent change from baseline in primary tophus size as determined by physical measurement was calculated as [(Week 28 - baseline sizes)/baseline]*100 for the subset of subjects with a primary palpable tophus at the Screening Visit. If the primary tophus was no longer palpable at the Week 28 visit, the size was assumed to be zero.|Baseline and Week 28|Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug, who had a baseline serum urate ≥8.0 mg/dL, and who had a palpable primary tophus measured at baseline. Missing data were not imputed.||percent change from baseline||Inter-Quartile Range|Median
711554|NCT00174915|Secondary|Percent Change From Baseline in Serum Urate Levels at Final Visit|The percent change in serum urate from baseline to the Final visit was summarized. The percent change in serum urate was calculated as [(Final visit - baseline levels)/baseline]*100. The final visit was the last visit at which a serum urate value was collected. The timing of the final visit may have differed for each subject.|Baseline and Final Visit (up to 28 weeks)|Analysis was performed on the ITT subjects, which were defined as all randomized subjects. who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL. Missing data were not imputed.||Percent change||Standard Deviation|Mean
711555|NCT00174915|Secondary|Percent Change From Baseline in Serum Urate Levels at Week 28.|Serum urate values were obtained at the Week 28 visit. The percent change in serum urate was calculated as [(Week 28 - baseline levels)/baseline]*100 and summarized.|Baseline and Week 28|Analysis was performed on the ITT subjects, which were defined as all randomized subjects. who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL. Missing data were not imputed.||Percent change||Standard Deviation|Mean
711556|NCT00174915|Secondary|Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Final Visit|The percentage of subjects whose serum urate was <6.0 mg/dL at the final visit was summarized. The final visit was the last visit at which a serum urate value was collected and may have differed by subject.|Final Visit (up to 28 weeks).|Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL. Missing data were not imputed.||Percentage of subjects|||Number
711557|NCT00174915|Secondary|Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Week 28|Serum urate values were obtained at the Week 28 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Week 28 visit was summarized.|Week 28|Analysis was performed on intend to treat (ITT) subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL. Missing data were not imputed.||Percentage of subjects|||Number
711558|NCT00174915|Primary|Percentage of Subjects Whose Last Three Serum Urate Levels Are <6.0 Milligram Per Deciliter (mg/dL).|Each subject’s serum urate at the last 3 visits determined the subject’s response for the primary efficacy variable. A subject who prematurely discontinued without least 3 postbaseline serum urate levels was considered a nonresponder; if at least 3 serum urate were obtained postbaseline, those 3 visits were used. The last 3 visits used may have differed for each subject.|Last 3 visits (any last 3 visits up to week 28)|Analysis was performed on all randomized subjects who took at least 1 dose of study drug and had a baseline serum urate ≥8.0 mg/dL. If subject prematurely discontinued from study before at least 3 serum urate levels were obtained, subject was considered a nonresponder; if at least 3 serum urate were obtained postbaseline, those 3 visits were used.||Percentage of subjects|||Number
711559|NCT00174941|Secondary|Percent Change in Serum Urate Levels From Baseline at Final Visit.|The percent change in serum urate from baseline to the final visit was summarized. The final visit was the last visit at which a serum urate value was collected.|Baseline and Last Visit on treatment (up to 66 months).|Two subjects who did not have any post-baseline Serum Urate Level measurements were excluded from this analysis. Results were summarized by the dose the subject was receiving at the time of the final visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.||percent change from baseline||Standard Deviation|Mean
711560|NCT00174941|Secondary|Percent Change in Serum Urate Levels From Baseline at Month 60 Visit.|The secondary outcome was the mean percent change from baseline to Month 60 visit as assessed by serum urate levels collected at baseline and at the Month 60 visit by dose at observation.|Baseline and Month 60|Subjects with a serum urate value at the Month 60 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 60 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.||percent change from baseline||Standard Deviation|Mean
711561|NCT00174941|Secondary|Percent Change in Serum Urate Levels From Baseline at Month 48 Visit.|Serum urate values were obtained at the Month 48 visit. The percent change in serum urate from baseline to the Month 48 visit was summarized.|Baseline and Month 48|Subjects with a serum urate value at the Month 48 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 48 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.||percent change from baseline||Standard Deviation|Mean
711562|NCT00174941|Secondary|Percent Change in Serum Urate Levels From Baseline at Month 36 Visit.|Serum urate values were obtained at the Month 36 visit. The percent change in serum urate from baseline to the Month 36 visit was summarized.|Baseline and Month 36|Subjects with a serum urate value at the Month 36 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 36 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.||percent change from baseline||Standard Deviation|Mean
711743|NCT00179478|Secondary|Annualized Relapse Rate|annualized # of relapses between years 0 and 10|10 years|Analysis only in 10 year completers||annualized relapses per year||Standard Deviation|Mean
711563|NCT00174941|Secondary|Percent Change in Serum Urate Levels From Baseline at Month 24 Visit.|Serum urate values were obtained at the Month 24 visit. The percent change in serum urate from baseline to the Month 24 visit was summarized.|Baseline and Month 24|Subjects with a serum urate value at the Month 24 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 24 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.||percent change from baseline||Standard Deviation|Mean
711564|NCT00174941|Secondary|Percent Change in Serum Urate Levels From Baseline at Month 18 Visit.|Serum urate values were obtained at the Month 18 visit. The percent change in serum urate from baseline to the Month 18 visit was summarized.|Baseline and Month 18|Subjects with a serum urate value at the Month 18 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 18 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.||percent change from baseline||Standard Deviation|Mean
711565|NCT00174941|Secondary|Percent Change in Serum Urate Levels From Baseline at Month 12 Visit.|Serum urate values were obtained at the Month 12 visit. The percent change in serum urate from baseline to the Month 12 visit was summarized.|Baseline and Month 12|Subjects with a serum urate value at the Month 12 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 12 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.||percentage of subjects||Standard Deviation|Mean
711566|NCT00174941|Primary|Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Final Visit.|The percentage of subjects whose serum urate was <6.0 mg/dL at the final visit was summarized. The final visit was the last visit at which a serum urate value was collected.|Last Visit on treatment (up to 66 months).|Two subjects who did not have any post-baseline Serum Urate Level measurements were excluded from this analysis. Results were summarized by the dose the subject was receiving at the time of the final visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.||percentage of subjects|||Number
711567|NCT00174941|Primary|Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 60 Visit.|Serum urate values were obtained at the Month 60 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 60 visit was summarized.|Month 60|Subjects with a serum urate value at the Month 60 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 60 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.||percentage of subjects|||Number
711568|NCT00174941|Primary|Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 48 Visit.|Serum urate values were obtained at the Month 48 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 48 visit was summarized.|Month 48|Subjects with a serum urate value at the Month 48 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 48 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.||percentage of subjects|||Number
711569|NCT00174941|Primary|Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 36 Visit.|Serum urate values were obtained at the Month 36 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 36 visit was summarized.|Month 36|Subjects with a serum urate value at the Month 36 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 36 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.||percentage of subjects|||Number
711570|NCT00174941|Primary|Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 24 Visit.|Serum urate values were obtained at the Month 24 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 24 visit was summarized.|Month 24|Subjects with a serum urate value at the Month 24 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 24 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.||percentage of subjects|||Number
711571|NCT00174941|Primary|Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 18 Visit.|Serum urate values were obtained at the Month 18 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 18 visit was summarized.|Month 18|Subjects with a serum urate value at the Month 18 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 18 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.||percentage of subjects|||Number
711572|NCT00174941|Primary|Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 12 Visit.|Serum urate values were obtained at the Month 12 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 12 visit was summarized.|Month 12|Subjects with a serum urate value at the Month 12 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 12 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.||percentage of subjects|||Number
711573|NCT00174941|Secondary|Percent Change in Serum Urate Levels From Baseline at Month 6 Visit.|Serum urate values were obtained at the Month 6 visit. The percent change in serum urate from baseline to the Month 6 visit was summarized.|Baseline and Month 6|Subjects with a serum urate value at the Month 6 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 6 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.||percent change from baseline||Standard Deviation|Mean
711574|NCT00174941|Primary|Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 6 Visit.|Serum urate values were obtained at the Month 6 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 6 visit was summarized.|Month 6|Subjects with a serum urate value at the Month 6 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 6 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.||percentage of subjects|||Number
711575|NCT00174954|Primary|Measurement of Tophi by MRI - Difference in Volume Between Readers|Two independent readers determined volume of the same tophus by MRI at 2 separate visits scheduled no more than 10 days apart. Difference in Reader 2 volume and Reader 1 volume for the same tophus were pooled across visits.|Visit 1 (Day 1) and Visit 2 (Days 6-11)|Analysis was performed on the subjects with MRI tophus volume measurements from both readers at the same visit.||cm³||Standard Deviation|Mean
711576|NCT00174954|Primary|Measurement of Tophi by MRI - Difference in Volument Between Visits|Two independent readers determined volume of the same tophus by MRI at 2 separate visits scheduled no more than 10 days apart. Difference in volume between Visit 1 and 2 for the same tophus was pooled across readers.|Visit 1 (Day 1) and Visit 2 (Days 6-11)|Analysis was performed on the subjects with MRI tophus volume measurements at both visits from the same reader. Change in tophus size over 10 days was not expected.||centimeters³ (cm³)||Standard Deviation|Mean
711577|NCT00174967|Secondary|Percent Change in 24-hour Urine Uric Acid Level From Baseline to Day 28.|24-hour urine uric acid levels were obtained at the Day 28 visit. The percent change in 24-hour urine uric acid level from baseline to the Day 28 visit was summarized.|Baseline and Day 28.|The analysis was performed on ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had baseline serum urate ≥ 8.0 mg/dL. Missing data was not imputed||percent change from baseline||Standard Deviation|Mean
711578|NCT00174967|Secondary|Maximum Percent Change in Serum Urate Level From Baseline During the Entire Treatment Period.|Serum urate values were obtained at the Day 7, 14, 21,and 28 visits. The maximum percent change in serum urate levels obtained at any visit was summarized.|Baseline and Any visit (Day 7, 14, 21,or 28)|The analysis was performed on ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had baseline serum urate ≥ 8.0 mg/dL.||percent change from baseline||Standard Deviation|Mean
711579|NCT00174967|Secondary|Percent Change in Serum Urate Levels From Baseline to the Day 28 Visit.|Serum urate values were obtained at the Day 28 visit. The percent change in serum urate from baseline to the Day 28 visit was summarized.|Baseline and Day 28.|The analysis was performed on ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had baseline serum urate ≥ 8.0 mg/dL. The LOCF method was used to impute missing data. The baseline value was carried forward if no post-baseline visits were available.||percent change from baseline||Standard Deviation|Mean
711580|NCT00174967|Secondary|Percent Change in Serum Urate Levels From Baseline to the Day 21 Visit|Serum urate values were obtained at the Day 21 visit. The percent change in serum urate from baseline to the Day 21 visit was summarized.|Baseline and Day 21.|The analysis was performed on ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had baseline serum urate ≥ 8.0 mg/dL. The last observation carried forward (LOCF) method was used to impute missing data. The baseline value was carried forward if no post-baseline visits were available.||percent change from baseline||Standard Deviation|Mean
711581|NCT00174967|Secondary|Percent Change in Serum Urate Levels From Baseline to the Day 14 Visit.|Serum urate values were obtained at the Day 14 visit. The percent change in serum urate from baseline to the Day 14 visit was summarized.|Baseline and Day 14.|The analysis was performed on ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had baseline serum urate ≥ 8.0 mg/dL. The LOCF method was used to impute missing data. The baseline value was carried forward if no post-baseline visits were available.||percent change from baseline||Standard Deviation|Mean
711582|NCT00174967|Secondary|Percent Change in Serum Urate Levels From Baseline to the Day 7 Visit.|Serum urate values were obtained at the Day 7 visit. The percent change in serum urate from baseline to the Day 7 visit was summarized.|Baseline and Day 7.|The analysis was performed on ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had baseline serum urate ≥ 8.0 mg/dL. The LOCF method was used to impute missing data. The baseline value was carried forward if no post-baseline visits were available.||percent change from baseline||Standard Deviation|Mean
711583|NCT00174967|Secondary|Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 mg/dL at the Day 21 Visit.|Serum urate values were obtained at the Day 21 visit. The percentage of subjects whose serum urate decreased to <6.0 mg/dL at the Day 21 visit was summarized.|Day 21.|The analysis was performed on ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had baseline serum urate ≥ 8.0 mg/dL. The LOCF method was used to impute missing data. The baseline value was carried forward if no post-baseline visits were available.||percentage of subjects|||Number
711584|NCT00174967|Secondary|Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 mg/dL at the Day 14 Visit.|Serum urate values were obtained at the Day 14 visit. The percentage of subjects whose serum urate decreased to <6.0 mg/dL at the Day 14 visit was summarized.|Day 14.|The analysis was performed on ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had baseline serum urate ≥ 8.0 mg/dL. The LOCF method was used to impute missing data. The baseline value was carried forward if no post-baseline visits were available.||percentage of subjects|||Number
711585|NCT00174967|Secondary|Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 mg/dL at the Day 7 Visit.|Serum urate values were obtained at the Day 7 visit. The percentage of subjects whose serum urate decreased to <6.0 mg/dL at the Day 7 visit was summarized.|Day 7.|The analysis was performed on ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had baseline serum urate ≥ 8.0 mg/dL. The LOCF method was used to impute missing data. The baseline value was carried forward if no post-baseline visits were available.||percentage of subjects|||Number
711586|NCT00174967|Primary|Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 Milligram Per Deciliter (mg/dL) at the Day 28 Visit.|Serum urate values were obtained at the Day 28 visit. The percentage of subjects whose serum urate decreased to <6.0 mg/dL at the Day 28 visit was summarized.|Day 28.|Analysis performed on intent-to-treat (ITT) subjects, defined as all randomized subjects who took at least 1 dose of study drug and who had baseline serum urate ≥8.0 mg/dL. The last observation carried forward (LOCF) method was used to impute missing data. The baseline value was carried forward if no postbaseline visits were available.||percentage of subjects|||Number
711587|NCT00175006|Primary|Average Percent Difference in Area Between Raters|Each rater measured length and width (mm) of the tophus at 2 visits separated by no more than 10 days. Area of the tophus was summarized using the average percent difference, calculated as the absolute difference of Raters 1 and 2 divided by the average of Raters 1 and 2 for the same tophus, pooled across visits.|Visit 1 (Day 1 ) and Visit 2 (Day 6-11)|Measurements of 52 tophi were obtained at 2 separate visits separated by no more than 10 days from the 13 subjects enrolled.||mm²||Standard Deviation|Mean
712231|NCT00194792|Primary|Overall Survival|From the start of protocol therapy until the date of death from any cause or the last date the patient was known to be alive. Kaplan-Meier estimate assessed at 5 years.|Up to 5 years|||survival probability||95% Confidence Interval|Number
711588|NCT00175006|Primary|Average Percent Difference in Area Between Visits|The rater measured length and width (mm) of the tophus at 2 visits separated by no more than 10 days. Area of the tophus was summarized using average percent difference, calculated as absolute difference of Visits 1 and 2 divided by the average of Visits 1 and 2 for the same tophus, pooled across raters.|Visit 1 (Day 1) and Visit 2 (Days 6-11)|Measurements of 52 tophi were obtained at 2 separate visits separated by no more than 10 days from the 13 subjects enrolled. Change in tophus size over 10 days was not expected.||mm²||Standard Deviation|Mean
711589|NCT00175019|Secondary|Percentage of Subjects Requiring Treatment for Gout Flare After Month 12.|The percentage of subjects requiring treatment for gout flare after the first 12 months of final stable treatment was summarized.|After Month 12 to Final Visit|Results were summarized by final stable treatment which was the treatment a subject was receiving after drug and/or dose changes were no longer allowed. A subject who reported more than one gout flare during the time interval was counted only once.||percentage of subjects|||Number
711590|NCT00175019|Secondary|Percentage of Subjects Requiring Treatment for Gout Flare up to Month 12.|The percentage of subjects requiring treatment for gout flare during the first twelve months of final stable treatment was summarized.|Month 12|Results were summarized by final stable treatment which was the treatment a subject was receiving after drug and/or dose changes were no longer allowed. A subject who reported more than one gout flare during the time interval was counted only once.||percentage of subjects|||Number
711591|NCT00175019|Secondary|Percent Change From Baseline in the Total Number of Tophi for Subjects With Palpable Tophi at Final Visit.|The number of tophi were counted at baseline and final visits. The percent change from baseline in the number of tophi to the final visit was summarized.|Final Visit (up to 40 months).|Results were summarized by final stable treatment which was the treatment a subject was receiving after drug and/or dose changes were no longer allowed. Subjects with a primary tophus at baseline who also had their tophi counted while receiving their final stable treatment were included in the analysis.||percent change from baseline||Standard Deviation|Mean
711592|NCT00175019|Secondary|Percent Change From Baseline in Primary Tophus Size at Final Visit for Subjects With Palpable Tophi Measured at Baseline.|The area of the primary tophus was calculated based on the length and width of the tophus measured at baseline and final visit. The percent change from baseline in primary tophus size to the final visit was summarized.|Final Visit (up to 40 months).|Results were summarized by final stable treatment which was the treatment a subject was receiving after drug and/or dose changes were no longer allowed. Subjects with a primary tophus at baseline which was also measured while receiving their final stable treatment were included in the analysis.||percent change from baseline||Inter-Quartile Range|Median
711593|NCT00175019|Secondary|Percent Change From Baseline in Primary Tophus Size at Month 36 for Subjects With Palpable Tophi Measured at Baseline.|The area of the primary tophus was calculated based on the length and width of the tophus measured at baseline and Month 36 visit. The percent change from baseline in primary tophus size to the Month 36 visit was summarized.|Month 36|Results were summarized by final stable treatment which was the treatment a subject was receiving after drug and/or dose changes were no longer allowed. Subjects with a primary tophus at baseline which was also measured at the Month 36 visit were included in the analysis.||percent change from baseline||Inter-Quartile Range|Median
711594|NCT00175019|Secondary|Percent Change From Baseline in Primary Tophus Size at Month 24 for Subjects With Palpable Tophi Measured at Baseline.|The area of the primary tophus was calculated based on the length and width of the tophus measured at baseline and Month 24 visit. The percent change from baseline in primary tophus size to the Month 24 visit was summarized.|Month 24|Results were summarized by final stable treatment which was the treatment a subject was receiving after drug and/or dose changes were no longer allowed. Subjects with a primary tophus at baseline which was also measured at the Month 24 visit were included in the analysis.||percent change from baseline||Inter-Quartile Range|Median
711595|NCT00175019|Primary|Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Last Visit on Treatment.|The percentage of subjects whose serum urate was <6.0 mg/dL at the last visit on treatment was summarized. The last visit on treatment was the last visit at which a serum urate value was collected prior to any changes in drug and/or dose from the initial treatment assignment.|Last Visit on treatment (up to 40 months).|Results were summarized by the initial treatment the subject was assigned to before any changes in drug and/or dose. All subjects with a post-baseline serum urate level measurement while receiving their initial treatment were included in the analysis.||percentage of subjects|||Number
711596|NCT00175019|Primary|Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Month 36.|Serum urate values were obtained at the Month 36 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 36 visit was summarized.|Month 36|Results were summarized by the initial treatment the subject was assigned to before any changes in drug and/or dose. Subjects with a serum urate value at the Month 36 visit and who had not changed from their initial treatment were included in the analysis.||percentage of subjects|||Number
711597|NCT00175019|Primary|Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Month 24.|Serum urate values were obtained at the Month 24 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 24 visit was summarized.|Month 24|Results were summarized by the initial treatment the subject was assigned to before any changes in drug and/or dose. Subjects with a serum urate value at the Month 24 visit and who had not changed from their initial treatment were included in the analysis.||percentage of subjects|||Number
711598|NCT00175019|Primary|Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Month 12.|Serum urate values were obtained at the Month 12 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 12 visit was summarized.|Month 12|Results were summarized by the initial treatment the subject was assigned to before any changes in drug and/or dose. Subjects with a serum urate value at the Month 12 visit and who had not changed from their initial treatment were included in the analysis.||percentage of subjects|||Number
711599|NCT00175019|Primary|Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Month 1.|Serum urate values were obtained at the Month 1 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 1 visit was summarized.|Month 1|Results were summarized by the initial treatment the subject was assigned to before any changes in drug and/or dose. Subjects with a serum urate value at the Month 1 visit and who had not changed from their initial treatment were included in the analysis.||percentage of subjects|||Number
711600|NCT00175019|Secondary|Percent Change From Baseline in Primary Tophus Size at Month 12 for Subjects With Palpable Tophi Measured at Baseline.|The area of the primary tophus was calculated based on the length and width of the tophus measured at the Month 12 visit. The percent change from baseline in primary tophus size to the Month 12 visit was summarized.|Month 12|Results were summarized by final stable treatment which was the treatment a subject was receiving after drug and/or dose changes were no longer allowed. Subjects with a primary tophus at baseline which was also measured at the Month 12 visit were included in the analysis.||percent change from baseline||Inter-Quartile Range|Median
711601|NCT00175019|Secondary|Percent Change in Serum Urate Levels From Baseline to the Last Visit on Treatment.|The percent change in serum urate from baseline to the last visit on treatment was summarized. The last visit on treatment was the last visit at which a serum urate value was collected prior to any changes in drug and/or dose from the initial treatment assignment.|Last Visit on treatment (up to 40 months).|Results were summarized by the initial treatment the subject was assigned to before any changes in drug and/or dose. All subjects with a post-baseline serum urate level measurement while receiving their initial treatment were included in the analysis.||percent change from baseline||Standard Deviation|Mean
711602|NCT00182754|Secondary|Average Quality-of-life|Quality of life will be recorded and analyzed in a descriptive, exploratory fashion. We acknowledge that this study will represent the first to attempt a prospective assessment of quality of life in patients with symptomatic ascites. The underlying hypothesis of this quality of life assessment is that patients who are receiving octreotide will enjoy a better quality of life compared to patients who receive placebo. Quality of life scores from the CLDQ will be summed for all patients on a monthly basis. Again we anticipate high patient drop out rates over time within these two cohorts. With due diligence, we will attempt to ascertain the reason for each patient drop out, and appropriate imputation techniques will be employed for each.Quantified as: 1='All of the time' 2='Most of the time' 3='A good bit of the time' 4='Some of the time' 5='A little bit of the time' 6='Hardly any of the time' 7='None of the time' 0='Missing';|Up to 2 years|||QOL score||Full Range|Median
711603|NCT00182754|Secondary|Number of Paracenteses|We will compare the number of paracenteses between groups. Parametric or nonparametric testing will be used as appropriate.|Up to 2 years|||number of paracenteses per patient||Full Range|Median
711604|NCT00182754|Primary|Median Time to Paracentesis|Kaplan Meier curves will be constructed for each group; patients lost to follow up will be censored. A log rank test will be used to compare groups. We will adjust for the volume of fluid withdrawn at paracentesis and for change in abdominal circumference between baseline and the next procedure because a patient may require an extra paracentesis if only a small volume is withdrawn at baseline.|Up to 2 years|||days||Full Range|Median
711605|NCT00182767|Primary|Maximum Tolerated Dose|The phase I component of the study included 30 patients with breast and ovarian cancer. A protocol amendment was made during phase I trial from a treatment regimen of Schedule A (ixabepilone every 3-4 weeks) to Schedule B (ixabepilone every week). The maximum tolerated dose was determined to be the preceding dose of any dose that resulted in 2 DLT events. Schedule B was carried forward to the phase II trial. The Maximum Tolerated Dose for Schedule B is reported. Please see (Chuang et al., 2010) for additional details|Once 2 DLT events occur in patients during the first 28 days of treatment (cycle 1), the preceding dose will be designated the maximum tolerated dose (MTD).|The phase I component of the study included 30 patients with breast and ovarian cancer.||mg/m2|||Number
711606|NCT00182767|Secondary|Progression-free Survival|We will summarize progression-free survival by Kaplan-Meier survival analysis.|The time from start of treatment to time of progression or death, assessed up to 2 years|||months||95% Confidence Interval|Median
711607|NCT00182767|Secondary|Proportion of Patients Responding to Therapy (Complete Response [CR], Partial Response [PR], or Stable Disease [SD]), Assessed According to Response Evaluation Criteria in Solid Tumors (RECIST) and Cancer Antigen-125 (CA-125) Response Criteria (Phase II)||Up to 2 years|||participants|||Number
711608|NCT00182767|Primary|Incidence of Dose-limiting Toxicity (DLT), Graded Using the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Version 4.0 (Phase I)|Dose-Limiting Toxicities are assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events classification and usually encompasses all grade 3 or higher toxicities|28 days|||participants|||Number
711609|NCT00182793|Primary|5-Year Overall Survival Rate|Estimated using the product-limit method of Kaplan and Meier. Patients who were still alive were censored at the date of last follow-up|From time of initial PBPC rescue until the date of death from any cause, assessed up to 5 years post treatment.|Patients from this study were combined with patients from a follow-up study in which 27 patients from this study met the eligibility requirements for meta-analysis.||percentage of participants||95% Confidence Interval|Median
711610|NCT00182793|Primary|5-Year Relapse-free Survival Rate|Estimated using the product-limit method of Kaplan and Meier. Relapse defined as appearance of any new lesions during or after protocol treatment. Whenever possible, relapses should be documented histologically.|From time of initial PBPC rescue until death or disease recurrence (disease progression for patients with stage IV disease), whichever came first, up to 5 years post treatment|Patients from this study were combined with patients from a follow-up study in which 27 patients from this study met the eligibility requirements for meta-analysis.||percentage of participants||95% Confidence Interval|Median
711611|NCT00183963|Secondary|Number of Participants With Changes in Mammographic Density|The mammograms will be scanned and a validated computer based threshold method will be used to determine the mammographic densities.|6 months after treatment of last patient enrolled|Analysis was not conducted since there was only 1 subject accrued on to each of the treatment arms.|||||
711612|NCT00183963|Primary|Number of Participants With Molecular Changes in Markers of Cell Proliferation and Apoptosis Associated With Treatment|Molecular measures of effect will be measured in tissue obtained at baseline biopsy (paraffin specimen) and on surgical specimen obtained at end of 3 weeks of treatment.|6 months after treatment of last patient enrolled|Analysis was not conducted since there was only 1 subject randomized on to each of the treatment arms.|||||
711613|NCT00184002|Secondary|Number of Patients With Serious Adverse Events as a Measure of Safety and Tolerability|Summary of grade 3 or higher toxicities (per Common Toxicity Criteria version 2.0) which generally is described as severe adverse reaction or symptom.|At end of every cycle|||Participants|||Count of Participants
712232|NCT00194792|Primary|Disease-free Survival|Kaplan-Meier estimate assessed at 5 years|Up to 5 years|||disease free survival probability||95% Confidence Interval|Number
711614|NCT00184002|Primary|Percentage of Patients With Complete Response to the Combination Chemotherapy|"Initial disease response tests will be performed after cycle 4 on all patients. Subsequent assessments after cycles 6 and/or 8 will depend on response. If after 4 cycles of therapy complete response or partial response has been documented, therapy will continue. If stable or progressive disease has been documented, the patient will be withdrawn from the study.
Response to the study treatment will be determined according to the criteria proposed in the “Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin’s Lymphomas” by Cheson et al (23)."|At completion of cycle 4, 6, and 8|||Percentage of participants|||Number
711615|NCT00184028|Secondary|Number of Participants With Serious Adverse Events (SAEs)|Safety evaluation according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|At end of every cycle|All participants who started treatment||Participants|||Number
711616|NCT00184028|Primary|Tumor Response|"All eligible patients who received the first dose of Taxotere will be included in the analysis.
Tumor Response will be categorized as: Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive Disease (PD), Early Death from Malignant Disease.
Per RECIST criteria, CR = disappearance of all target and nontarget lesions; PR = at least a 30% decrease in the sum of the largest diameter (LD) of target lesions taking as reference the baseline sum LD; SD = neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD since the treatment started; PD = at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions."|6 months after the last subject enrolled has gone off study|||Participants|||Number
711617|NCT00184054|Secondary|Number of Participants With Severe (Grades 3-5) Adverse Events|Patients who received any amount of ATO plus Ascorbic Acid are included in the safety analyses.|Days 1, 8, 15, 21, 28, 35 of each cycle and at end of treatment (30 days after last dose or start of new therapy)|||Participants|||Number
711618|NCT00184054|Primary|Number of Participants With a Response (Complete Remissions (CR) and Complete Remission With Incomplete Blood Count Recovery (CRi)|Complete Remission (CR): ANC >=1000/mcl, Platelet count >=100,000/mcl, Bone marrow <5% blasts. Complete Remission with incomplete blood count recovery (CRi): Same as CR but ANC may be <1,000/mcl and/or platelet count <100,000/mcl. Patients who failed to achieve CR or CRi after two cycles were considered treatment failures. Patients who did not complete at least two cycles were not evaluated for response.|Up to 1 year|All subjects who received at least 2 cycles of treatment as part of this study are included in the analysis of response.||participants|||Number
711619|NCT00184093|Secondary|Best Overall Response of Either a Complete Response (CR) or Partial Response (PR)|"Participants who complete the 6 weeks of chemotherapy and radiation or who experience dose limiting toxicity or who progress at any time prior to completion of the 6 weeks of chemotherapy and radiation will be evaluable for response.
Complete response (CR): Complete disappearance of all measurable and evaluable disease. No new lesions. No disease related symptoms. No evidence of nonevaluable disease, including normalization of markers and other abnormal lab values. All measurable, evaluable, and nonevaluable lesions and sites must be assessed using the same technique as baseline.
Partial response (PR): Applies only to patients with at least one measurable lesion. Greater than or equal to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions. All measurable and evaluable lesions and sites must be assessed using the same techniques as baseline."|Baseline to response (up to 24 months)|||Participants|||Count of Participants
711620|NCT00184093|Primary|Toxicity (Number of Participants With Serious Adverse Events)|Summary of grade 3 or higher toxicities as per Common Toxicity Criteria version 2.0. Phase 1 and 2 Combined (N=35)|Every 3 weeks from start of study until 30 days after the last dose of treatment|||Participants|||Count of Participants
711621|NCT00184548|Secondary|Number of Units of All Allogeneic Transfusions From Time of First Dose|The number of units of all allogeneic transfusions in the first 24 hours from the time of the first dose of rFVIIa or placebo.|from hour 0 to 24|Blunt trauma patient population: Intention-to-treat (ITT) analysis set, including patients who discontinued before day 30. Penetrating Trauma patient population: No analysis done due to low statistical power.||Units of allogeneic transfusions||Standard Deviation|Mean
711622|NCT00184548|Secondary|Number of Patients Receiving 10 Units or More (Massive Transfusion) of Red Blood Cells From Time of Injury|The number of patients receiving 10 units or more of red blood cells in the first 24 hours from the time of injury.|from hour 0 to 24|Blunt trauma patient population: Intention-to-treat (ITT) analysis set including patients who discontinued before day 30. Penetrating Trauma patient population: No analysis done due to low statistical power.||Participants|||Number
711623|NCT00184548|Secondary|Number of Units of Transfused Red Blood Cells From Time of First Dose|The number of units of transfused red blood cells in the first 24 hours from the time of the first dose of rFVIIa or placebo.|from hour 0 to 24|Blunt trauma patient population: Intention-to-treat (ITT) analysis set including patients who discontinued before day 30. Penetrating Trauma patient population: No analysis done due to low statistical power.||Units of transfused red blood cells||Standard Deviation|Mean
711624|NCT00184548|Secondary|Time to Death From Time of First Dose|The time of first dose refers to the time of the first dose of rFVIIa or placebo.|from day 0 to day 30|There is no measure summary for time to event type of endpoint as this would be a Kaplan-Meier graph.|||||
711625|NCT00184548|Secondary|Number of Days Alive and Free of Pulmonary and/or Renal Dysfunction Requiring Medical Intervention|The number of days alive and free of pulmonary and/or renal dysfunction requiring medical intervention from day 0 to day 30.|from day 0 to day 30|Blunt trauma patient population: Intention-to-treat (ITT) analysis set. Penetrating Trauma patient population: No analysis done due to low statistical power.||Days||Standard Deviation|Mean
711626|NCT00184548|Primary|Morbidity|Morbidity reflects the number of patients who had pulmonary and/or renal dysfunction requiring ongoing medical intervention on day 30.|from day 0 to day 30|Blunt trauma patient population: According to protocol, morbidity is not part of the primary endpoint since non-inferiority test of mortality was not passed. Penetrating Trauma patient population: No analysis done due to low statistical power.|||||
711627|NCT00184548|Primary|Mortality|Number of participants to die from day 0 to day 30 from all causes.|from day 0 to 30|Blunt trauma patient population: Intention-to-treat (ITT) analysis set. Patients who discontinued (withdrawn or lost to follow up) before day 30 were excluded from analyses. Penetrating Trauma patient population: No analysis done due to low statistical power.||Participants|||Number
711629|NCT00184600|Secondary|Quality of Life as Measured by the EuroQol Group 5-Dimension Self-Report Questionnaire Score (EQ5D) at 36 Months|The EuroQol Group 5-Dimension Self-Report Questionnaire score (EQ5D) is a standardised instrument for use as a measure of health outcome in medical research. Responses can be used to generate a single numerical value associated with a given health state. The scale of values is graded from -0.59 to 1.00, with lower scores indicating a poorer health status. A score of 0 represents no quality of life and scores less than 0 represent states perceived by the respondent to be worse than death.|Month 36|Intention to treat analyses (ITT) included all those randomised. Missing data was imputed by SAS Proc MI (Multiple Imputation), using the non-parametric Propensity Score method for data with monotone missing pattern under the assumption of non-normality and the Bayesian Monte Carlo Markov Chain approach for data with values missing intermittently.||units on a scale||95% Confidence Interval|Mean
711630|NCT00184600|Secondary|Quality of Life as Measured by the EuroQol Group 5-Dimension Self-Report Questionnaire Score (EQ5D) at 12 Months|The EuroQol Group 5-Dimension Self-Report Questionnaire score (EQ5D) is a standardised instrument for use as a measure of health outcome in medical research. Responses can be used to generate a single numerical value associated with a given health state. The scale of values is graded from -0.59 to 1.00, with lower scores indicating a poorer health status. A score of 0 represents no quality of life and scores less than 0 represent states perceived by the respondent to be worse than death.|Month 12|Intention to treat analyses (ITT) included all those randomised. Missing data was imputed by SAS Proc MI (Multiple Imputation), using the non-parametric Propensity Score method for data with monotone missing pattern under the assumption of non-normality and the Bayesian Monte Carlo Markov Chain approach for data with values missing intermittently.||units on a scale||95% Confidence Interval|Mean
711631|NCT00184600|Secondary|Change in Eight-point Capillary Plasma Glucose Profiles (Self-measured) at 36 Months|For each visit and telephone contact, participants were asked to perform in advance three capillary glucose profiles (using blood glucose metre provided for the trial) obtained before breakfast and before the evening meal for participants in the biphasic and basal groups and before meals and two hours after meals and at bedtime in the prandial group.|Baseline, month 36|Intention to treat analyses (ITT) included all those randomised. Missing data was imputed by SAS Proc MI (Multiple Imputation), using the non-parametric Propensity Score method for data with monotone missing pattern under the assumption of non-normality and the Bayesian Monte Carlo Markov Chain approach for data with values missing intermittently.||mg/dL||Standard Deviation|Mean
711632|NCT00184600|Secondary|Change in Eight-point Capillary Plasma Glucose Profiles (Self-measured) at 12 Months|For each visit and telephone contact, participants were asked to perform in advance three capillary glucose profiles (using blood glucose metre provided for the trial) obtained before breakfast and before the evening meal for participants in the biphasic and basal groups and before meals and two hours after meals and at bedtime in the prandial group.|Baseline, month 12|Intention to treat analyses (ITT) included all those randomised. Missing data was imputed by SAS Proc MI (Multiple Imputation), using the non-parametric Propensity Score method for data with monotone missing pattern under the assumption of non-normality and the Bayesian Monte Carlo Markov Chain approach for data with values missing intermittently.||mg/dL||Standard Deviation|Mean
711633|NCT00184600|Secondary|Change From Baseline in Body Weight at Month 36||Week 0 (baseline), month 36|Intention to treat analyses (ITT) included all those randomised. Missing data was imputed by SAS Proc MI (Multiple Imputation), using the non-parametric Propensity Score method for data with monotone missing pattern under the assumption of non-normality and the Bayesian Monte Carlo Markov Chain approach for data with values missing intermittently.||kilograms||Standard Deviation|Mean
711634|NCT00184600|Secondary|Change From Baseline in Body Weight at Month 12||Week 0 (baseline), month 12|Intention to treat analyses (ITT) included all those randomised. Missing data was imputed by SAS Proc MI (Multiple Imputation), using the non-parametric Propensity Score method for data with monotone missing pattern under the assumption of non-normality and the Bayesian Monte Carlo Markov Chain approach for data with values missing intermittently.||kilogram||Standard Deviation|Mean
711635|NCT00184600|Secondary|Percentage of Participants Who Required A Second Insulin Therapy by Month 36|Percentage of participants who required a second insulin formulation to be added to their treatment. This outcome offers evidence to the efficacy and durability of the insulin regimens.|Month 36|Intention to treat analyses (ITT) included all those randomised. Missing data was imputed by SAS Proc MI (Multiple Imputation), using the non-parametric Propensity Score method for data with monotone missing pattern under the assumption of non-normality and the Bayesian Monte Carlo Markov Chain approach for data with values missing intermittently.||percentage of participants|||Number
711636|NCT00184600|Secondary|Percentage of Participants Who Required A Second Insulin Therapy by Month 12|Percentage of participants who required a second insulin formulation to be added to their treatment. This outcome offers evidence to the efficacy and durability of the insulin regimens.|Month 12|Intention to treat analyses (ITT) included all those randomised. Missing data was imputed by SAS Proc MI (Multiple Imputation), using the non-parametric Propensity Score method for data with monotone missing pattern under the assumption of non-normality and the Bayesian Monte Carlo Markov Chain approach for data with values missing intermittently.||percentage of participants|||Number
711637|NCT00184600|Secondary|Number of Hypoglycaemic Events Per Participant Per Year at Month 36 for All Participants and the Subset Who Achieved Target HbA1c Below or Equal to 6.5%|Rate of hypoglycaemic events was calculated as the median number of events per participant per year, defined as grade 1 (symptoms only), 2 (minor) and 3 (major). Symptoms only if self-measured plasma glucose level of 3.1 mmol/L (56 mg/dL) or more. Minor (grade 2) if able to treat her/himself and plasma glucose was below 3.1 mmol/L (56 mg/dL). Major (grade 3) if unable to treat her/himself. Rates are reported for all participants and for the subset of participants who achieved target HbA1c below or equal to 6.5%.|Month 36|Intention to treat analyses (ITT) included all those randomised. Missing data was imputed by SAS Proc MI (Multiple Imputation), using the non-parametric Propensity Score method for data with monotone missing pattern under the assumption of non-normality and the Bayesian Monte Carlo Markov Chain approach for data with values missing intermittently.||hypoglycaemic events/participant/year||Inter-Quartile Range|Median
711744|NCT00179478|Primary|Rate of Development of Clinical Definite Multiple Sclerosis (CDMS) Over 10 Years|Percent cumulative probability of developing CDMS over 10 years . CDMS was defined as the development of new visual or neurological symptoms discrete from the patients initial event with objective findings on examination.|10 years|||Percent cumulative probability||95% Confidence Interval|Number
711638|NCT00184600|Secondary|Number of Hypoglycaemic Events Per Participant Per Year at Month 12 for All Participants and the Subset Who Achieved Target HbA1c Below or Equal to 6.5%|Rate of hypoglycaemic events was calculated as the median number of events per participant per year, defined as grade 1 (symptoms only), 2 (minor) and 3 (major). Symptoms only if self-measured plasma glucose level of 3.1 mmol/L (56 mg/dL) or more. Minor (grade 2) if able to treat her/himself and plasma glucose was below 3.1 mmol/L (56 mg/dL). Major (grade 3) if unable to treat her/himself. Rates are reported for all participants and for the subset of participants who achieved target HbA1c below or equal to 6.5%.|Month 12|Intention to treat analyses (ITT) included all those randomised. Missing data was imputed by SAS Proc MI (Multiple Imputation), using the non-parametric Propensity Score method for data with monotone missing pattern under the assumption of non-normality and the Bayesian Monte Carlo Markov Chain approach for data with values missing intermittently.||hypoglycaemic events/participant/year||Inter-Quartile Range|Median
711639|NCT00184600|Secondary|Percentage of Participants Achieving a Month 36 Value in HbA1c Below or Equal to 6.5%|Percentage of participants who achieved the target (HbA1c below or equal to 6.5%) at Month 36|Month 36|Intention to treat analyses (ITT) included all those randomised. Missing data was imputed by SAS Proc MI (Multiple Imputation), using the non-parametric Propensity Score method for data with monotone missing pattern under the assumption of non-normality and the Bayesian Monte Carlo Markov Chain approach for data with values missing intermittently.||percentage of participants|||Number
711640|NCT00184600|Secondary|Percentage of Participants (Total Participants and the Subset of Participants Who Did Not Have an Hypoglycaemic Episode) Achieving a Month 12 Value in HbA1c Below or Equal to 6.5%|Two participant counts are listed. The first is the percentage of total participants who achieved the target (HbA1c below or equal to 6.5%) at Month 12. The second is the percentage of subset of participants who achieved the target and did not have either minor or major hypoglycaemic episode within the four weeks prior to the month 12 exam. Minor hypoglycaemic episode is an episode in which the participant was able to treat her/himself and plasma glucose was below 3.1 mmol/L (56 mg/dL). Major hypoglycaemic episode is an episode in which the participant was unable to treat her/himself.|Month 12|Intention to treat analyses (ITT) included all those randomised. Missing data was imputed by SAS Proc MI (Multiple Imputation), using the non-parametric Propensity Score method for data with monotone missing pattern under the assumption of non-normality and the Bayesian Monte Carlo Markov Chain approach for data with values missing intermittently.||percentage of participants|||Number
711641|NCT00184600|Primary|HbA1c (Glycosylated Haemoglobin) at Month 36|HbA1c values offer evidence of the efficacy and durability of the insulin regimens.|Baseline, Month 36|Intention to treat analyses (ITT) included all those randomised. Missing data was imputed by SAS Proc MI (Multiple Imputation), using the non-parametric Propensity Score method for data with monotone missing pattern under the assumption of non-normality and the Bayesian Monte Carlo Markov Chain approach for data with values missing intermittently.||percentage (%) of total haemoglobin||Standard Deviation|Mean
711642|NCT00184600|Primary|HbA1c (Glycosylated Haemoglobin) at Month 12|HbA1c values offer evidence of the efficacy and durability of the insulin regimens.|Baseline, Month 12|Intention to treat analyses (ITT) included all those randomised. Missing data was imputed by SAS Proc MI (Multiple Imputation), using the non-parametric Propensity Score method for data with monotone missing pattern under the assumption of non-normality and the Bayesian Monte Carlo Markov Chain approach for data with values missing intermittently.||percentage (%) of total haemoglobin||Standard Deviation|Mean
711643|NCT00184717|Secondary|Adverse Events - Subjects Received NN220 Treatment for 4 Years|Occurrence of Adverse Events (AEs) during treatment period (TEAEs), occurrence of possibly/probably related AEs during the treatment period, and occurrence of Serious Adverse Events (SAEs) during the treatment period. An AE is any undesirable medical event occurring to a subject in a clinical trial, whether or not related to the trial product(s). An SAE is an experience that at any dose is fatal, life-threatening, disabling or which results in the patient being hospitalised or, if already in hospital, that hospitalisation is prolonged, or ocurrence of congenital anomaly|Weeks 0-208|Safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity||Subjects|||Number
711644|NCT00184717|Secondary|Adverse Events - Subjects Received NN220 Treatment for 5 Years|Occurrence of Adverse Events (AEs) during treatment period (TEAEs), occurrence of possibly/probably related AEs during the treatment period, and occurrence of Serious Adverse Events (SAEs) during the treatment period. An AE is any undesirable medical event occurring to a subject in a clinical trial, whether or not related to the trial product(s). An SAE is an experience that at any dose is fatal, life-threatening, disabling or which results in the patient being hospitalised or, if already in hospital, that hospitalisation is prolonged, or ocurrence of congenital anomaly|Weeks 0-260|Safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity||Subjects|||Number
711645|NCT00184717|Secondary|Change in Bone Age (Left Hand X-Ray) at Week 208 - Subjects Received NN220 Treatment for 4 Years|Bone age is measured as years and months (displayed as xx.x years).Change in Bone age = Bone age at 52*i weeks – Bone age at 52*(i-1) weeks, i=1, 2, ….|Week 0, week 208|Endpoint Analysis Set (EAS) consisted of subjects who participated in GHLIQUID-1517 in the Full Analysis Set (FAS). FAS consisted of subjects who were randomised in each group and have any available efficacy data after receiving NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity||years||Standard Deviation|Mean
711646|NCT00184717|Secondary|Change in Bone Age (Left Hand X-Ray) at Week 260 - Subjects Received NN220 Treatment for 5 Years|Bone age is measured as years and months (displayed as xx.x years). Change in Bone age = Bone age at 52*i weeks – Bone age at 52*(i-1) weeks, i=1, 2, ….|Week 0, week 260|Endpoint Analysis Set (EAS) consisted of subjects who participated in GHLIQUID-1517 in the Full Analysis Set (FAS). FAS consisted of subjects who were randomised in each group and have any available efficacy data after receiving NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity||years||Standard Deviation|Mean
711669|NCT00185458|Secondary|Progestogenic Symptom 8: Greasy Hair (as Measured by a VAS)|Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.|Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase|ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.||score on a scale||Standard Deviation|Mean
711647|NCT00184717|Secondary|Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 4 Years|Yearly Height velocity SDS for chronological age were summarised and graphically presented|Weeks 0-208|Endpoint Analysis Set (EAS) consisted of subjects who participated in GHLIQUID-1517 in the Full Analysis Set (FAS). FAS consisted of subjects who were randomised in each group and have any available efficacy data after receiving NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity||Standard Deviation Score (SDS)||Standard Deviation|Mean
711648|NCT00184717|Secondary|Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 5 Years|Yearly Height velocity SDS for chronological age were summarised and graphically presented|Weeks 0-260|Endpoint Analysis Set (EAS) consisted of subjects who participated in GHLIQUID-1517 in the Full Analysis Set (FAS). FAS consisted of subjects who were randomised in each group and have any available efficacy data after receiving NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity||Standard Deviation Score (SDS)||Standard Deviation|Mean
711649|NCT00184717|Primary|Change in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Week 208 - Subjects Received NN220 Treatment for 4 Years|Height SDS for chronological age were derived as follow; {Height – mean (age, sex)}/ SD (age, sex), where mean (age, sex) and SD (age, sex) were mean and SD of height for corresponding chronological age and sex (data of those in 2000). Height SDS was calculated using mean of three height observations at corresponding visit|Week 0, week 208|Endpoint Analysis Set (EAS) consisted of subjects who participated in GHLIQUID-1517 in the Full Analysis Set (FAS). FAS consisted of subjects who were randomised in each group and have any available efficacy data after receiving NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity||Standard Deviation Score (SDS)||Standard Error|Least Squares Mean
711650|NCT00184717|Primary|Change in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Week 260 - Subjects Received NN220 Treatment for 5 Years|Height SDS for chronological age were derived as follow; {Height – mean (age, sex)}/ SD (age, sex), where mean (age, sex) and SD (age, sex) were mean and SD of height for corresponding chronological age and sex (data of those in 2000). Height SDS was calculated using mean of three height observations at corresponding visit|Week 0, week 260|Endpoint Analysis Set (EAS) consisted of subjects who participated in GHLIQUID-1517 in the Full Analysis Set (FAS). FAS consisted of subjects who were randomised in each group and have any available efficacy data after receiving NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity||Standard Deviation Score (SDS)||Standard Error|Least Squares Mean
711651|NCT00185211|Secondary|MRI-based Efficacy Domain: Percentage Change of Brain Volume From Screening MRI to Month 60|Two-timepoint percentage brain volume change was estimated with Structural Image Evaluation, using Normalisation, of Atrophy (SIENA) software. The measurements describe the percentage change from screening in brain volume at month 60.|60 months after start of treatment|The analysis followed the ITT principle. Not all patients in the full analysis set completed the follow-up study or had MRI scan readings at month 60 available. There were several missing values in both treatment arms regarding the percentage brain volume change.||Percentage of brain volume||Inter-Quartile Range|Median
711652|NCT00185211|Secondary|MRI-based Efficacy Domain: Absolute Change of Volume of Black Holes From Screening MRI to Month 60|Absolute change of volume of black holes from screening MRI to month 60 was calculated as volume of black holes at month 60 minus volume of black holes at screening.|60 months after start of treatment|The analysis followed the ITT principle. Not all FAS patients completed the follow-up study or had MRI scan readings at month 60 available.||cubic millimeter||Inter-Quartile Range|Median
711653|NCT00185211|Secondary|MRI-based Efficacy Domain: Absolute Change of T2 Lesion Volume From Screening MRI to Month 60|Absolute change of T2 lesion volume from screening MRI to month 60 was calculated as T2 lesion volume at month 60 minus T2 lesion volume at screening.|60 months after start of treatment|The analysis followed the ITT principle. Not all FAS patients completed the follow-up study or had MRI scan readings at month 60 available.||cubic millimeter||Inter-Quartile Range|Median
711654|NCT00185211|Secondary|MRI (Magnet-Resonance Imaging)-Based Efficacy Domain: Cumulative Number of Newly Active Lesions at Month 60|Newly active lesions are defined as displaying either new Gadolinium (Gd)-enhancement on T1-weighted scans or non-enhancement on T1-weighted scan but new on T2-weighted scan. The numbers of newly active lesions on yearly MRI scans were summed up to the cumulative number.|up to 60 months after start of treatment|The analysis followed the ITT principle. Not all patients in the full analysis set completed the follow-up study or had MRI scan readings at month 60 available.||cumulative number of lesions||Inter-Quartile Range|Median
711655|NCT00185211|Secondary|Disability-based Efficacy Domain: Multiple Sclerosis Functional Composite (MSFC) at Month 60|"The MSFC score consists of three sub-tests (Timed-25-Foot-Walk, 9-Hole-Peg-Test, 3 Paced Auditory Serial Addition Test [PASAT]). Standardized results (Z-scores) of the sub-tests and the overall MSFC Z-score as an average of the three Z-scores were derived using baseline data pooled over both treatment arms as reference population. Higher Z-scores reflect a better neurological status."|60 months after start of treatment|The analysis followed the ITT principle. Not all FAS patients completed the follow-up study or had MSFC results at month 60 available.||Z-scores||Inter-Quartile Range|Median
711656|NCT00185211|Secondary|Relapse-based Efficacy Domain (Supportive): Annualized Relapse Rate|The annualized relapse rate is defined as total number of relapses up to month 60 divided by the total observation time (last clinical visit minus first day of study treatment administration plus 1 of all participants) in years.|up to 60 months after start of treatment|The analysis followed the ITT principle. For each treatment arm, the relapse rate is defined as total number of relapses up to month 60 divided by the total observation time in years.||number of relapses per patient and year||95% Confidence Interval|Mean
711657|NCT00185211|Secondary|Relapse-based Efficacy Domain: Hazard Ratio for Recurrent Relapses|A relapse was defined as the appearance of a new neurological abnormality or the reappearance of a neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The time to the onset of recurrent relapses was determined for each subject according to the counting process representation for recurrent events. Time to a relapse was right-censored if a relapse-risk period ended without relapse. Based on the Andersen-Gill model the hazard ratio for recurrent relapses was estimated. Annualized relapse rates are provided as another outcome measure.|up to 60 months after start of treatment|The analysis followed the Intention-To-Treat (ITT) principle. The hazard for recurrent relapses was modelled by an extension of the Cox Proportional Hazards (PH) regression model (Andersen-Gill Model).||Ratio|||Number
711658|NCT00185211|Secondary|Relapse-based Efficacy Domain: Time to Multiple Sclerosis (MS) According to McDonald Criteria|MS according to the criteria by McDonald was reached if, in addition to the single clinical demyelinating event, both dissemination in space and dissemination in time were established by MRI-criteria or a new relapse. Time to McDonald MS is the difference of date of McDonald MS to the date of Day 1 + 1. For subjects without McDonald MS, time to McDonald MS is the difference from the maximum (date of last magnetic resonance imaging scan, date of last clinical visit) to the date of Day 1 + 1 (right-censored observation).|up to 60 months after start of treatment|The analysis followed the ITT principle. After five years, in the initial placebo arm 151 participants and in the initial IFNB-1b arm 224 participants had reached McDonald MS diagnosis.||months||95% Confidence Interval|Median
711659|NCT00185211|Primary|Functional Assessment of Multiple Sclerosis (FAMS) Trial Outcome Index (TOI) at Month 60|As an index of health related quality of life in people diagnosed with MS, the FAMS Trial Outcome Index covers overall physical health (sum of sub-scale scores Mobility, Symptoms, Thinking/Fatigue, Additional Concerns) with a score range from 0 to 148. A higher score reflects a higher overall physical health as reported by patients.|60 months after start of treatment|The analysis followed the ITT principle. Not all patients who completed the follow-up study could be included at month 60 as subject to copyright constraints and to the availability of validated language versions, FAMS assessments could not be conducted in all patients.||units on a scale||Inter-Quartile Range|Median
711660|NCT00185211|Primary|Time to Confirmed Expanded Disability Status Scale (EDSS) Progression Represented by Kaplan-Meier Estimates of the Cumulative Percentage of Participants With Confirmed EDSS Progression at Selected Points in Time|"EDSS progression was defined as an increase in the expanded disability status scale (EDSS) of 1.0 point compared to the lowest EDSS score obtained during the screening or baseline visit, if this score was &lt;= 5.5. A confirmed EDSS progression status was defined as an EDSS progression observed at two consecutive scheduled visits at least 140 days apart from each other. The EDSS scale is a method of quantifying disability in multiple sclerosis in eight functional systems and values vary between 0=normal neurological examination and 10=death due to MS measured in half-points on a scale."|up to 60 months after start of treatment|The analysis followed the ITT principle. The 25%-percentile for time to confirmed EDSS progression was 908 days in the initial placebo arm but was not estimable in the initial IFNB-1b arm. After five years, in the initial placebo arm 47 participants and in the initial IFNB-1b arm 65 participants had reached confirmed EDSS progression.||percentage of particip. with EDSS progr.|||Number
711661|NCT00185211|Primary|Time to Clinically Definite Multiple Sclerosis (CDMS) Represented by Kaplan-Meier Estimates of the Cumulative Percentage of Participants With CDMS at Selected Points in Time|"CDMS could be reached due to a qualifying relapse or sustained progression of 1.5 points on the expanded disability status scale (EDSS) as compared to the lowest EDSS obtained during screening or Day 1. The validity of CDMS diagnoses was confirmed by a central committee. The EDSS scale quantifies disability in MS in 8 functional systems, values vary between 0=normal neurological examination and 10=death due to MS measured in half-points on an ordinal scale. Time to CDMS = date of CDMS - date of Day 1 + 1 or time to CDMS = date of last clinical visit - date of Day 1 + 1 (right-censored)"|up to 60 months after start of treatment|The analysis followed the intention to treat (ITT) principle. After five years, in the initial placebo arm 94 participants and in the initial IFNB-1b arm 124 participants had reached CDMS diagnosis.||cum. percentage of particip. with CDMS|||Number
711662|NCT00185380|Secondary|Bleeding Pattern by 90-day Reference Periods - Reference Period 12|Subjects kept a bleeding diary and recorded any bleeding every day by category: none, spotting, light, normal or heavy. Any missing data were obtained by direct questioning.|day 991 to day 1080|The analysis was performed on the FAS (all subjects with an insertion) and included subjects with bleeding or spotting or both.||days||Standard Deviation|Mean
711663|NCT00185380|Secondary|Bleeding Pattern by 90-day Reference Periods - Reference Period 4|Subjects kept a bleeding diary and recorded any bleeding every day by category: none, spotting, light, normal or heavy. Any missing data were obtained by direct questioning.|day 271 to day 360|The analysis was performed on the FAS (all subjects with an insertion) and included subjects with bleeding or spotting or both.||days||Standard Deviation|Mean
711664|NCT00185380|Secondary|Bleeding Pattern by 90-day Reference Periods - Reference Period 3|Subjects kept a bleeding diary and recorded any bleeding every day by category: none, spotting, light, normal or heavy. Any missing data were obtained by direct questioning.|day 181 to day 270|The analysis was performed on the FAS (all subjects with an insertion) and included subjects with bleeding or spotting or both.||days||Standard Deviation|Mean
711665|NCT00185380|Secondary|Bleeding Pattern by 90-day Reference Periods - Reference Period 2|Subjects kept a bleeding diary and recorded any bleeding every day by category: none, spotting, light, normal or heavy. Any missing data were obtained by direct questioning.|day 91 to day 180|The analysis was performed on the FAS (all subjects with an insertion) and included subjects with bleeding or spotting or both.||days||Standard Deviation|Mean
711666|NCT00185380|Secondary|Bleeding Pattern by 90-day Reference Periods - Reference Period 1|Subjects kept a bleeding diary and recorded any bleeding every day by category: none, spotting, light, normal or heavy. Any missing data were obtained by direct questioning.|day 1 to day 90|The analysis was performed on the FAS (all subjects with an insertion) and included subjects with bleeding or spotting or both.||days||Standard Deviation|Mean
711667|NCT00185380|Secondary|Number of Subjects With Total or Partial Expulsions|The numbers of subjects with partial or total IUS expulsions (device displaced from its correct position within the uterus) were to be given by treatment.|Up to 3 years|The analysis was performed on the FAS (all subjects who had an IUS inserted).||participants|||Number
711668|NCT00185380|Primary|Pearl Index|The Pearl Index (PI) is defined as the number of pregnancies per 100 woman years. The 3-year PI was obtained by dividing the number of pregnancies that occurred during the first three years of treatment by the time (in 100 women years) that the women were under risk of getting pregnant.|Up to 3 years|All randomized women with a successful insertion were analyzed according to the treatment actually received and were included in the FAS, which was the set used for all safety and efficacy analyses. The PPS was identical to the FAS.||Number per 100 women years||95% Confidence Interval|Median
711972|NCT00191334|Secondary|Duration of Response|The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.|every other 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up|||weeks||95% Confidence Interval|Median
711671|NCT00185458|Secondary|Climacteric Symptom 6: Breast Tension (as Measured by a VAS)|Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.|Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase|ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.||score on a scale||Standard Deviation|Mean
711672|NCT00185458|Secondary|Climacteric Symptom 5: Irritability (as Measured by a VAS)|Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.|Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase|ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.||score on a scale||Standard Deviation|Mean
711673|NCT00185458|Secondary|Climacteric Symptom 4: Sleep Problems (as Measured by a VAS)|Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.|Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase|ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.||score on a scale||Standard Deviation|Mean
711674|NCT00185458|Secondary|Climacteric Symptom 3: Vaginal Dryness (as Measured by a VAS)|Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.|Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase|ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.||score on a scale||Standard Deviation|Mean
711675|NCT00185458|Secondary|Climacteric Symptom 2: Sweating Episodes (as Measured by a VAS)|Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.|Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase|ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.||score on a scale||Standard Deviation|Mean
711676|NCT00185458|Secondary|Climacteric Symptom 1: Hot Flushes (as Measured by a VAS)|Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.|Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase|ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.||score on a scale||Standard Deviation|Mean
711677|NCT00185458|Secondary|Progestogenic Symptom 6: Decreased Libido (as Measured by a VAS)|Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.|Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase|ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.||score on a scale||Standard Deviation|Mean
711678|NCT00185458|Secondary|Progestogenic Symptom 5: Edema (as Measured by a VAS)|Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.|Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase|ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.||score on a scale||Standard Deviation|Mean
711679|NCT00185458|Secondary|Progestogenic Symptom 4: Nausea (as Measured by a VAS)|Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.|Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase|ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.||score on a scale||Standard Deviation|Mean
711680|NCT00185458|Secondary|Progestogenic Symptom 3: Acne or Greasy Skin (as Measured by a VAS)|Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.|Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase|ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.||score on a scale||Standard Deviation|Mean
711681|NCT00185458|Secondary|Progestogenic Symptom 2: Depressive Mood (as Measured by a VAS)|Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.|Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase|ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.||score on a scale||Standard Deviation|Mean
711682|NCT00185458|Secondary|Progestogenic Symptom 1: Headache (as Measured by a Visual Analogue Scale (VAS))|Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.|Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase|ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.||score on a scale||Standard Deviation|Mean
711683|NCT00185458|Secondary|Continuation Rates|Percentage of subjects continuing in the study at the given time points.|At entry, at 2 years, at 4 years|ITT. Kaplan-Meier estimator given.||Percentage of participants continuing|||Number
711684|NCT00185458|Secondary|Assessment of QOL as Measured by Women's Health Questionnaire|Women's Health Questionnaire (Total Score). For the Total score, the minimum is 36 and maximum is 144. A higher score means the distress and dysfunction are less pronounced.|Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase|ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.||score on a scale||Standard Deviation|Mean
711685|NCT00185458|Primary|Percentage of Participants With Successful Treatment|"Definition of successful treatment:
Completion of HRT phase, and
Both, the number of bleeding days and the number of spotting days during HRT was equal to or less than during contraceptive phase, and
The number of bleeding days and the number of spotting days could be calculated for at least 3 out of the first 4 reference periods in HRT"|Last 90 days in Contraception Phase and first 360 days in HRT Phase|ITT; all subjects eligible for the HRT||Percentage of participants with success|||Number
711686|NCT00185458|Primary|Number of Spotting Days|Measured by using Subject Diaries (Subject Reported Data)|Last 90 days in Contraception Phase and first 360 days in HRT Phase|ITT; all subjects with adequate bleeding diary data. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.||Spotting days||Inter-Quartile Range|Median
711687|NCT00185458|Primary|Number of Bleeding Days|Measured by using Subject Diaries (Subject Reported Data)|Last 90 days in Contraception Phase and first 360 days in Hormone-Replacement Therapy (HRT) Phase|Intention to treat population (ITT); all subjects with adequate bleeding diary data. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.||Bleeding days||Inter-Quartile Range|Median
711688|NCT00185588|Secondary|Time-to-Progression, Evaluable Patients|Represents the evaluable subset of subjects that terminated from the study due to disease progression (endpoint). Does not include any other form of treatment failure, nor lost-to-follow-up.|12 months|"Evaluable subset of subjects that terminated from the study due to disease progression (endpoint).
No participants were analyzed in the Stage 1 Dose Exploration 2 - Gemcitabine 850 + Vatalanib 2 x 250 / 2 x 500 group because no evaluable participants progressed within 12 months."||months||Full Range|Median
711689|NCT00185588|Primary|Time-to-Treatment Failure (Intent-To-Treat Analysis)|"For the purposes of an Intent-to-Treat (ITT) analysis, Time-to-Treatment Failure (TTF) was defined as the time from treatment initiation to treatment discontinuation for any reason, including disease progression, treatment toxicity, patient preference, lost-to-follow-up, or death.
Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0)."|12 months|||months||Full Range|Median
711690|NCT00185640|Secondary|Transplant-related Mortality|Reports the proportion of participants who expired within 1 year due to any complication or failure of the transplant.|1 year|||percentage of participants|||Number
711691|NCT00185640|Secondary|Event-free Survival (EFS)|Reports the proportion of subjects who neither died due to any cause nor experienced relapse.|3 and 5 years|||percentage of participants|||Number
711692|NCT00185640|Secondary|Overall Survival (OS)||3 and 5 years|||percentage of participants|||Number
711693|NCT00185640|Secondary|Incidence of Relapse|Reports the overall rate of disease relapse, occurring any time within 3 years after transplant|3 years|||percentage of participants|||Number
711694|NCT00185640|Secondary|Acute Graft vs Host Disease (GvHD), All Evaluable|"The incidence of acute GvHD after transplantation was assessed per Glucksberg GvHD grade, a compound scale based on the following combinations of disease stages.
Skin manifestations Skin Stages
0: No rash
1: Maculopapular (MP) rash <25% of body surface area
2: MP rash on 25-50% of body surface area
3: Generalized erythroderma (ED)
4: Generalized ED with bullous formation and desquamation
Liver Stages (Bilirubin in mg/dL)
0: <2
1: 2-3
2: 3.01-6
3: 6.01-15.0
4: >15
Gastrointestinal (GI) Stages (diarrhea)
0: None or < 500 mL/day
1: 500-999 mL/day
2: 1000-1499 mL/day
3: >1500 mL/day
4: Severe abdominal pain, with or without ileus
Glucksberg Overall grade
Grade 1: Skin 1/2; GI 0; Liver 0; Karnofsky performance scale (KPS) 90-100%.
Grade 2: Skin 1-3; GI 1; Liver 1; KPS 70-80
Grade 2: Skin 2/3; GI 2/3; Liver 2-4; KPS 50-60
Grade 4: Skin 2-4; GI 2-4; Liver 2-4; KPS 30-40"|100 days post-transplant|||percentage of participants|||Number
711695|NCT00185640|Primary|Acute Graft vs Host Disease (GvHD)|"The incidence of acute GvHD after transplantation was assessed per Glucksberg GvHD grade, a compound scale based on the following combinations of disease stages.
Skin manifestations Skin Stages
0: No rash
1: Maculopapular (MP) rash <25% of body surface area
2: MP rash on 25-50% of body surface area
3: Generalized erythroderma (ED)
4: Generalized ED with bullous formation and desquamation
Liver Stages (Bilirubin in mg/dL)
0: <2
1: 2-3
2: 3.01-6
3: 6.01-15.0
4: >15
Gastrointestinal (GI) Stages (diarrhea)
0: None or < 500 mL/day
1: 500-999 mL/day
2: 1000-1499 mL/day
3: >1500 mL/day
4: Severe abdominal pain, with or without ileus
Glucksberg Overall grade
Grade 1: Skin 1/2; GI 0; Liver 0; Karnofsky performance scale (KPS) 90-100%.
Grade 2: Skin 1-3; GI 1; Liver 1; KPS 70-80
Grade 2: Skin 2/3; GI 2/3; Liver 2-4; KPS 50-60
Grade 4: Skin 2-4; GI 2-4; Liver 2-4; KPS 30-40"|100 days post-transplant|Reports the incidence of Grades 2 to 4 acute GvHD, as observed for the initial 37 participants treated on this study, who constitute the Primary Analysis for the study. See linked citation Lowsky, et al. NEJM. 29Sep2005;353(13)1321-1331.||percentage of participants|||Number
711696|NCT00185679|Secondary|Platelet Recovery|Number of subjects recovering platelets to > 20x10e9/L, assessed on the 7th day unsupported by platelet transfusions|40 days|||participants|||Number
711697|NCT00185679|Secondary|Acute GvHD (Grade II-IV)|Number of subjects with acute GvHD (grade II-IV) within 100 days post-transplant, per the Consensus Conference on Acute GvHD Grading (Przepiorka D, et al. Bone Marrow Transplantation. 1995. 15:825-828).|within 100 days post-transplant|||participants|||Number
711698|NCT00185679|Primary|Neutrophil Engraftment|Number of subjects recovering neutrophils, assessed as 1st of 3 consecutive days on which ANC > 0.5x10e9/L|30 days post-transplant|||participants|||Number
711699|NCT00185692|Secondary|Acute Graft-versus-Host Disease (GVHD) Grade 2-4 Risk From Time of Transplant Until Day 90 Post-transplant|GVHD grading system goes from 0-4 where grade 4 is the most severe. Grade 0 and 1 do not require systemic treatment, Grade 2-4 require treatment. This trial evaluated the risk of developing acute GVHD grades 2-4 within 90 days of transplant.|90 days|||Participants|||Count of Participants
711700|NCT00185692|Primary|Engraftment of Haploidentical CD34+ Selected Blood Stem Cells in Older Patients or Those With Medical Co-morbidities Following Total Lymphoid Irradiation and Antithymocyte Globulin Transplant Conditioning|number achieving donor cell engraftment (>95%) by day 90 after transplant.|100 days|||Participants|||Count of Participants
711701|NCT00185965|Primary|Objective Response Rate (ORR)|Objective Response Rate (ORR) consisting of Complete Response (CR) + Partial Response (PR), not including Stable Disease (SD)|12 weeks|||percentage of treated subjects|||Number
712278|NCT00189423|Secondary|Survival to 90 Days|Number of patients who are known to be alive 90 days after the index cardiac arrest.|90 days following cardiac arrest|Population is a modified Intent to Treat (mITT) population that met initial and final inclusion criteria.||patients|||Number
711702|NCT00186017|Secondary|Mean Change in Hamilton Anxiety Rating Scales (HAM-A)|"The HAM-A was one of the first rating scales developed to measure the severity of anxiety symptoms, and is still widely used today in both clinical and research settings. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). The HAM-A does not provide any standardized probe questions. Despite this,the reported levels of interrater reliability for the scale appear to be acceptable.
Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0–56, where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe."|Baseline, 1 Week|||units on a scale||Standard Deviation|Mean
711703|NCT00186017|Secondary|Mean Change in MADRS After 1 Week of Treatment.|Montgomery-Asberg Depression Rating Scales (MADRS) is a multi-item clinician tool assessing depression. Each item yields a score of 0 to 6. The overall score ranges from 0 to 60. Higher MADRS score indicates more severe depression.|Baseline, 1 week|||units on a scale||Standard Deviation|Mean
711704|NCT00186017|Secondary|Mean Change in YMRS After 1 Week of Treatment|"The Young Mania Rating Scale (YMRS) scale has 11 items and is based on the patient’s subjective report of his or her clinical condition over the previous 48 hours. Responses to each item are summed with a higher score indicating more mania symptoms endorsed.
Scale:0-60 0=Good 60=Bad"|Baseline, 1 week|||units on a scale||Standard Deviation|Mean
711705|NCT00186017|Primary|Mean Change in CGI-BP-OS After 1 Week of Treatment|The Clinical Global Impression - bipolar version – overall severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1, normal, not ill; 2, minimally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, very severely ill|Baseline, 1 Week|||units on a scale||Standard Deviation|Mean
711706|NCT00186043|Primary|Percentage of Participants With Clinical Global Impression for Bipolar Disorders Overall Severity Remission (Score <=2 at Week 8)|"0-7 scale: rated on the following seven-point scale:) 0=not assessed, 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients.
This rating is based upon observed and reported symptoms, behavior, and function in the past seven days."|Week 8|One participant randomized to the Placebo group did not complete any post-baseline visits and is not included in the analysis.||percentage of participants|||Number
711707|NCT00186043|Secondary|Percentage of Participants With 50% Improvement From Baseline in Both Montgomery Asberg Depression Rating Scale (MADRS) and Young Mania Rating Scale (YMRS) Scores|MADRS assesses change from baseline to endpoint. Higher score indicates more severe depression; each item yields a score of 0 to 6. Overall score ranges: 0 to 60. Questions following symptoms 1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts. Cutoff points:0 to 6– normal/symptom absent; 7 to 19– mild depression; 20 to 34– moderate depression; >34– severe depression. YMRS:a 11-item clinician-admin instrument assesses severity of mania. Symptoms rated: Elevated mood, Increased motor activity/energy, Sexual interest, Sleep, irritability, Speech, language/thought disorder, Content, Disruptive/aggressive behavior, Appearance, Insight. Each composed of five explicitly defined levels of severity. Severity ratings based on patient's subjective report of clinical condition during past 48 hours and clinician's observations.|Baseline and 8 weeks|One participant randomized to the Placebo group did not complete any post-baseline visits and is not included in the analysis.||percentage of participants|||Number
711708|NCT00186043|Primary|Percentage of Participants With >=50% Improvement From Baseline in Clinical Global Impression for Bipolar Disorders Overall Severity|"0-7 scale: rated on the following seven-point scale:) 0=not assessed, 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients.
This rating is based upon observed and reported symptoms, behavior, and function in the past seven days."|Baseline and 8 weeks|One participant randomized to the Placebo group did not complete any post-baseline visits and is not included in the analysis.||percentage of participants|||Number
711709|NCT00186056|Primary|Hamilton Depression Rating Scale|"Hamilton Depression Rating Scale. Minimum score of 0 (no depressive symptoms) to maximum of 68 (very severely depressed).
Outcome Measure is reporting a Change from Baseline in HAMD scores, i.e., scores at Day 35 minus scores at Baseline."|Baseline and Day 35 HAMD scores|||units on a scale||Standard Deviation|Mean
711710|NCT00186069|Secondary|Neonatal Apgar Score at 5 Minutes|The median Apgar score at 5 minutes. Apgar score scale is from 0 to 10 with score 0 expressing the worst neonatal status and score 10 the best status.|At 5 minutes after birth|||Apgar score||Full Range|Median
711711|NCT00186069|Secondary|Gestational Age at Delivery (Weeks)|Median gestational age at delivery (in full weeks)|Time of delivery|||weeks of gestation||Full Range|Median
711712|NCT00186069|Primary|Undelivered With Resolution of Vaginal Bleeding and Contractions in First 48 Hours|The primary outcome was the proportion of women undelivered at 48 hours with resolution of vaginal bleeding and uterine contractions.|48 hours after the randomization|||participants|||Number
711713|NCT00186186|Secondary|Response to the Divalproex-ER in Acute Bipolar 2 Depression.|A reduction greater than or equal to 50% in MADRS total score from baseline to the endpoint.|7 weeks|||participants|||Number
711714|NCT00186186|Primary|Montgomery Asberg Depression Rating Scale (MADRS)|"The Montgomery–Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders.
Higher MADRS score indicates more severe depression the overall score ranges from 0 to 60.
Usual cutoff points are:
0 to 6 – normal/symptom absent 7 to 19 – mild depression 20 to 34 – moderate depression >34 – severe depression."|Baseline, 7 weeks|||units on a scale||Standard Deviation|Mean
711715|NCT00178633|Secondary|Change in Left Ventricular Mass|Change in left ventricular mass, or myocardium, as measured in centimeters using echocardiography. Negative values represent a decrease in ventricular mass.|0-9 Months|broken out into 0-3months and 3-9months below||g/m^2.7||95% Confidence Interval|Mean
711716|NCT00178633|Secondary|Change in Tissue Doppler Diastolic Velocity|Change in tissue doppler diastolic velocity. Negative values indicate a decrease in tissue doppler diastolic velocity.|0-9 Months|Analysis broken down into 0-3 months and 3-9 months||cm/s||95% Confidence Interval|Mean
711719|NCT00178685|Secondary|7 Day Point Prevelence (7DPP)|Seven-day point prevalence abstinence (7DPP) was assessed by asking: “Have you smoked a cigarette, even a puff, in the last 7 days?”16 Participants were also asked if they had smoked cigars or pipe, chewed tobacco, or used snuff in the past 7 days, and if they responded yes they were considered tobacco users.|12 months after the intervention|820 individuals were randomized to condition, of those, 12 died during the course of the study (all deaths were found to be unrelated to the study). Final analysis number included all those randomized and excluded those who died during the study.||participants|||Number
711720|NCT00178685|Primary|12 Month Prolonged Abstinence From Tobacco Measured at 12 Months From Completion of Intervention.|The primary outcome measure was 12-month prolonged abstinence (12M-PA) assessed by patient self-report 12-months after the intervention ended. If participant responded that they had not smoked a cigarette, even a puff, in the last 7 days at 12 months post-intervention, and reported date of last cigarette was 365 days or more prior to assessment date, then they were considered to have 12 month prolonged abstinence. A baseline-observation-carried-forward (BOCF)strategy was used for missing data such that those not reporting smoking status 12 months post-intervention were considered smoking.|12 months after subject completes intervention.|A baseline-observation-carried-forward (BOCF)strategy was used for missing data such that those not reporting smoking status 12 months post-intervention were considered smoking.||participants|||Number
711721|NCT00178711|Other Pre-specified|Controlled Oral Word Association Test||0-12 months||||||
711722|NCT00178711|Other Pre-specified|Grooved Pegboard||0-12 months||||||
711723|NCT00178711|Other Pre-specified|Verbal Selective Reminding Test Trails B||0-12 months||||||
711724|NCT00178711|Other Pre-specified|Rey Osterrieth Complex Figure||0-12 months||||||
711725|NCT00178711|Other Pre-specified|Symbol Digit Modalities Test||0-12 months||||||
711726|NCT00178711|Other Pre-specified|Neurological Outcome Scale for Traumatic Brain Injury||0-12 months||||||
711727|NCT00178711|Other Pre-specified|Neurobehavioral Rating Scale – Revised||0-12 months||||||
711728|NCT00178711|Other Pre-specified|Disability Rating Scale||assessed 0-12 months||||||
711729|NCT00178711|Other Pre-specified|Glasgow Outcome Scale - Extended||0-12 months||||||
711730|NCT00178711|Primary|The Dichotomized Glasgow Outcome Scale|The primary outcome measure was the Glasgow Outcome Scale measured in person six months after injury by examiners who were blinded to the patient's treatment group. Good recovery and moderate disability were designated as favorable outcomes; severe disability, a vegetative state, and death as poor outcomes.|6 months with a window of plus or minus one month|Intention to Treat||participants with a poor outcome|||Number
711731|NCT00178841|Secondary|Pruritus Score|10-cm visual analog scale, 10= worst, 1=best|16 weeks|||units on a scale||Full Range|Mean
711732|NCT00178841|Secondary|Quality of Life Evaluations|FACT-G, Functional Assessment of Cancer Therapy-General (quality-of-life scale) 0= worst 108=best|baseline and every 4 weeks|||units on a scale||Full Range|Mean
711733|NCT00178841|Primary|Number of Participants With a 50% Improvement in Baseline Skin Score|mSWAT scoring. Range 0 to 400. Measured every 4 weeks.|16 weeks|||participants|||Number
711734|NCT00178919|Primary|Systolic Blood Pressure in Response to Systemic Nitric Oxide Inhibition|Systolic blood pressure at the highest tolerated dose of IV infusion of L-NMMA during autonomic nervous system blockade with trimethaphan. Trimethaphan, infused intravenously was used to produce transient blockade of the autonomic nervous system to allow for a full response to nitric oxide inhibition (in the absence of the baroreflex.|End of 15 minutes of infusion of L-NMMA at the highest tolerated dose|||mm Hg||Standard Deviation|Mean
711735|NCT00178919|Primary|Change in Systolic Blood Pressure|L-NMMA (nitric oxide synthase inhibitor) was infused intravenously at different doses for 15 minutes each, after blocking the autonomic nervous system with trimethaphan. The change in systolic blood pressure at the end of the highest tolerated dose is the main outcome. Trimethaphan infused intravenously was used to produce transient blockade of the autonomic nervous system to allow for a full response to nitric oxide inhibition (in the absence of the baroreflex.|At the end of the highest tolerated dose of IV infusion of L-NMMA|||mm Hg||Standard Error|Mean
711736|NCT00179309|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|80 months|||Participants|||Number
711737|NCT00179309|Primary|Progression-free Survival (PFS)|Time between the first day of treatment and disease progression. Progression is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Progressive disease is a minimum of 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since the treatment started or the appearance of one or more new measurable lesions.|19.7 months|||Months||95% Confidence Interval|Median
711738|NCT00179413|Secondary|Development of Portal Hypertension|Number of patients who develop endoscopic evidence of varices over 4 year period|4 years|The number of patients at risk include only those patients who at the baseline endoscopy had no evidence of portal hypertension or varices||Participants|||Count of Participants
711739|NCT00179413|Secondary|Evaluation of Safety and Tolerability of Long Term Maintenance PEG-Intron in Patients With Cirrhosis|Defined as the number of patients who discontinued therapy due to an adverse event side|4 years|||Participants|||Count of Participants
711740|NCT00179413|Primary|Determination of the Effect of PEG-Intron 0.5mg Per kg Weekly sc Versus Colchicine 0.6mg Bid Daily on:|number of patients with a liver related outcomes including: mortality, liver transplant, variceal or portal hypertensive bleeding,Development of jaundice, ascites or encephalopathy with an increase in CPT of > 2 points and development of hepatoma|4 years|||Participants|||Count of Participants
711741|NCT00179478|Secondary|The Number of New or Enlarging MRI T2 Lesions at 10 Years|These are counts of new or significantly enlarged lesions over 10 years on brain MRI reflecting interval radiographic disease activity|10 years|Analysis restricted to those participants with MRI scans able to evaluate at 10 years||# of new or enlarging T2 lesions||Inter-Quartile Range|Median
711742|NCT00179478|Secondary|Number of Participants With an EDSS > 3.5 at Study Completion|The EDSS is an ordinal scale of neurological impairment in Multiple Sclerosis with a range of 0 to 10 with 0.5 increments. A score of 0 is normal and 10 is death from MS. Scores from 1 to 3.5 are considered mild impairment , 4.0 to 6.5 is moderate and greater than 6.5 is severe impairment.|10 years|Numbers of patients completing 10 year evaluations||Participants|||Count of Participants
711745|NCT00179517|Secondary|Changes in Energy, Mood and Anxiety Scores Will be More Favorable With Anastrozole Than With Placebo.|Changes in energy, mood and anxiety scores were measured using The Beck Depression Inventory II and the POMS questionnaire. The Beck Depression Inventory II questionnaire consisted of 21 questions, each with answers ranging from 0-3. The answers for each question were summed. The scale ranged from 0-63 with higher scores meaning a higher depression score (worse score). The POMS questionnaire had a total of 65 questions that measured tension, depression, anger, vigor, fatigue and confusion. The total POMS score ranged from 0-200, with lower scores being better. The POMS tension score ranged from 0-36 with lower scores being better. The POMS depression score ranged from 0-60 with lower scores being better. The POMS anger score ranged from 0-48, lower scores being better. The POMS vigor score ranged from 0-32, lower scores being better. The POMS fatigue score ranged from 0-28, lower scores being better. The POMS confusion score ranged from 0-28 with lower scores being better.|3 month average|||Scores on a scale||Standard Deviation|Mean
711746|NCT00179517|Secondary|Changes in Seizure Frequency Will be More Favorable With Anastrozole Than With Placebo.|The average change in number of seizures over the 3 month study for the depotestosterone plus anastrozole (T–A) and depotestosterone plus placebo (T–P) were reported.|3 month average|||number of seizures||Standard Deviation|Mean
711747|NCT00179517|Secondary|Estradiol and Luteinizing Hormone Ratios Will be Lower With Anastrozole Than Placebo.|Estradiol and luteinizing hormone levels were measured once a month over the three month study in the treatment and placebo group. The estradiol and luteinizing hormone levels were averaged. The ratio between the average estradiol levels and average luteinizing hormone levels were reported.|3 month average|||Ratio||Standard Deviation|Mean
711748|NCT00179517|Secondary|Bioactive Testosterone and Luteinizing Hormone Ratios Will be Higher With Anastrozole Than Placebo.|Bioactive Testosterone and luteinizing hormone levels were measured once a month over the three month study in the treatment and placebo group. The bioactive testosterone and luteinizing hormone levels were averaged. The ratio between the average bioactive testosterone level and average luteinizing hormone levels were reported.|3 month average|||Ratio||Standard Deviation|Mean
711749|NCT00179517|Secondary|The Bioactive Testosterone and Estradiol Ratio Will be Higher With Anastrozole Than With Placebo.|Bioactive Testosterone and estradiol levels were measured once a month over the three month study in the treatment and placebo group. The bioactive Testosterone and estradiol levels were averaged The ratio between the average bioactive testosterone level and average estradiol levels were reported.|3 month average|||Ratio||Standard Deviation|Mean
711750|NCT00179517|Secondary|Estradiol Levels Will Decrease More With Anastrozole Than With Placebo.|Estradiol levels were measured once a month over the three month study in the treatment and placebo group. The average change in estradiol levels was reported.|3 month average|||pg/mL||Standard Deviation|Mean
711751|NCT00179517|Secondary|Bioactive Testosterone Levels Will Increase More With Anastrozole Than With Placebo.|Bioactive testosterone levels were measured at baseline and once a month over the three month study. The average change in bioactive testosterone levels from baseline to the end of the three month study was reported.|3 month average|||ng/dl||Standard Deviation|Mean
711752|NCT00179517|Secondary|A Greater Proportion of Men Will Achieve Normalization of Sexual Scores (Sexual Interest Function) Using Anastrozole Than Placebo.|A greater proportion of men will achieve normalization of S-Scores (scores greater than or equal to 16/20) on anastrozole (T-A) than with placebo (T-P). Both Men who achieve normalization of sexual scores and those who did not achieve normalization of sexual scores were reported for anastrozole (T-A) treatment group and the placebo treatment group.|3 month average|||Participants|||Count of Participants
711753|NCT00179517|Primary|Sexual Function Scores, Calculated Using S-Score and Reynolds’ Sexual Questionnaires, Will Increase More Anastrozole and Testosterone Treatment Than With Placebo and Testosterone Treatment.|S-Scores and Reynolds Questionnaire scores were assessed at baseline and once a month over three months. The average change in score for each questionnaire over the 3 month study was reported. The S-Scores questionnaire measured sexual function and consisted of four questions with five possible answers. The total scale range was 0-20, with higher scores were considered better. S-Scores that were greater than or equal to 16/20 were considered normalized S-Scores. Reynolds Questionnaire is a 21 item survey that monitors sexual interest, activity, satisfaction, and function. The scale for the Reynolds questionnaire for sexual interest was from 0-12, with higher scores being better. The scale for sexual activity was 0-41 with higher scores being better. The sexual satisfaction scale was from 0-21 with higher scores being better. The scale for sexual function was from 0 to -12 with lower scores being better.|3 month average|||Scores on a Scale||Standard Deviation|Mean
711754|NCT00179621|Secondary|Summary of Participants Who Had Adverse Events (AE) During the Double-blind Period|"Counts of study participants who had adverse events (AEs) during the double-blind period by MedDRA System Organ Class (SOC) and preferred term. A participant with multiple occurrences of an adverse event within a category is counted only once in that category. Adverse events were evaluated by the investigator.
The National Cancer Institute (NCI)'s Common Terminology Criteria for AEs (CTCAE) was used to grade AE severity. Severity grade 3= severe and undesirable AE. Severity grade 4= life-threatening or disabling AE."|up to week 52|Safety population.||participants|||Number
711755|NCT00179621|Secondary|Change From Baseline in the Trial Outcome Index-Fatigue (TOI-F) Endpoints at Week 12|The Trial Outcome Index-Fatigue(TOI-F) composed of the physical and functional subscales of the FACT-G along with the fatigue items from the Anemia subscale was used to assess health-related quality of life (HRQoL). The overall score range for the TOI-F is 0-108. Higher scores indicate better HRQoL.|Baseline, Week 12|Participants who had both Baseline and Week 12 TOI-F data.||units on a scale||Standard Deviation|Mean
711756|NCT00179621|Secondary|Change From Baseline in the Trial Outcome Index-Anemia (TOI-An) Endpoints at Week 12|The Trial Outcome Index-Anemia (TOI-An) composed of the physical and functional subscales of the FACT-G along with the Anemia subscale was used to assess health-related quality of life (HRQoL). The overall score range for the TOI-An is 0-136. Higher scores indicate better HRQoL.|Baseline, Week 12|Participants who had both Baseline and Week 12 TOI-An data.||units on a scale||Standard Deviation|Mean
711768|NCT00179621|Primary|Participants Who Achieved Red Blood Cell (RBC) Transfusion Independence for >= 26 Weeks (182 Days)|The count of study participants who had no RBC transfusions for 26 consecutive weeks or more during the double-blind period.|Up to 52 weeks|The modified intent-to-treat (mITT) population included all participants with centrally-confirmed Low- or Int-1-risk MDS with del 5q[31] and documented RBC transfusion dependence who had received ≥ 1 dose of study drug.||Participants|||Number
711757|NCT00179621|Secondary|Change From Baseline in the Functional Assessment of Cancer Therapy-Anemia (FACT-An) Endpoints at Week 12|"The Functional Assessment of Cancer Therapy-Anemia (FACT-An) questionnaire (Yellen, 1997) was used to assess health-related quality of life (HRQoL).
In addition to general HRQoL, the FACT-An measures the impact of fatigue and other anemia-related symptoms on patient functioning. The overall score range for the FACT-An is 0-188. Higher scores indicate better HRQoL."|Baseline, Week 12|Participants who had both Baseline and Week 12 FACT-An data.||units on a scale||Standard Deviation|Mean
711758|NCT00179621|Secondary|Participant Count of Deaths During Double-blind and Open-label by Randomized Group|Count of participant deaths throughout the entire study and reported by the original treatment assignment.|up to 3 years|Safety Population||Participants|||Number
711759|NCT00179621|Secondary|Kaplan Meier Estimates of Overall Survival by Randomized Group|Kaplan Meier estimate for median length of survival for study participants as they were randomized at the start of the study.|up to 3 years|Safety population: All randomized participants who received any Lenalidomide or placebo.||Months||95% Confidence Interval|Median
711760|NCT00179621|Secondary|Participants Who Progressed to Acute Myeloid Leukemia (AML) During the Study|Number of participants who progressed to acute myeloid leukemia during the study, summarized at three different timepoints: first 16 weeks of the double-blind study, week 52 of the double-blind study, and up to 36 months which includes the double-blind and open-label periods of the study. The counts are cumulative by timeframe.|up to 3 years|Intent to treat population. Participants represented in the treatment groups to which they were randomized.||Participants|||Number
711761|NCT00179621|Secondary|Participants Showing Cytogenetic Response by the International MDS Working Group (IWG 2000) During Double-blind Period as Evaluated by Central Review|The IWG criteria for evaluating cytogenetic response require a minimum of 20 baseline and post-baseline analyzable metaphases using conventional cytogenetic techniques. A major cytogenetic response is defined as no detectable cytogenetic abnormality if preexisting abnormality was present whereas a minor response requires ≥50% reduction in abnormal metaphases. Progression could be concluded based on as few as 3 metaphases if there were additional abnormalities. The best response is represented.|up to 52 weeks|Modified intent to treat population, which is defined as participants with centrally-confirmed Low- or Int-1-risk MDS with del 5q[31] and documented RBC transfusion dependence who had received ≥ 1 dose of study drug. Participants had to have had more than 1 post-baseline assessment in order to be evaluable for cytogenetic response.||Participants|||Number
711762|NCT00179621|Secondary|Participants' Response Based on Bone Marrow Samples by the International MDS Working Group (IWG 2000) During Double-blind Period|The IWG criteria for bone marrow improvement: a complete remission is bone marrow sampling showing less than 5% myeloblasts with normal maturation of all cell lines, with no evidence for dysplasia. A partial remission is ≥ 50% decrease in blasts over pre-treatment. Bone marrow progression is a ≥ 50% increase in blasts that exceed the top range of the pretreatment percentile range: a) <5% blasts b) 5-10% blasts c) 10-20% blasts d) 20-30% blasts. For example, a participant with <5% blasts pretreatment with an on study blast increase of 50% which is now >5% showed bone marrow progression.|up to 52 weeks|Intent to treat population. Participants represented in the treatment groups to which they were randomized. Placebo response is limited to the double-blind phase. There were 10 responders in the placebo group who achieved their response under lenalidomide treatment after crossover to open-label.||Participants|||Number
711763|NCT00179621|Secondary|Participants' Response in Absolute Neutrophil Counts as Defined by the International MDS Working Group (IWG 2000) During Double-blind Period|A major neutrophil response is defined by the International MDS Working Group (IWG) criteria as at least a 100% increase, or an absolute increase of ≥500/mm^3 for participants with absolute neutrophil counts (ANC) of less than 1,500/mm^3 before therapy, whichever is greater. A minor response for such participants is defined as an ANC increase of at least 100%, but absolute increase <500/mm^3.|up to week 52|The modified intent-to-treat (mITT) population included all participants with centrally-confirmed Low- or Int-1-risk MDS with del 5q[31] and documented RBC transfusion dependence who had received ≥ 1 dose of study drug. Additionally, the participant must have had a baseline absolute neutrophil counts (ANC) < 1,000/mm^3.||Participants|||Number
711764|NCT00179621|Secondary|Participants' Response in Platelet Counts as Defined by the International MDS Working Group (IWG 2000) During Double-blind Period|The International MDS Working Group (IWG) defines a major platelet response for participants with a pre-treatment platelet count of <100,000/mm^3 as an absolute increase of ≥30,000/mm^3 whereas a minor response is defined as a ≥50% increase in platelet count with a net increase greater than 10,000/mm^3 but less than 30,000/mm^3.|up to 52 weeks|The modified intent-to-treat (mITT) population included all participants with centrally-confirmed Low- or Int-1-risk MDS with del 5q[31] and documented RBC transfusion dependence who had received ≥ 1 dose of study drug. Additionally, the participant must have had a baseline platelet count of <100,000/mm^3 to be included in the analysis.||Participants|||Number
711765|NCT00179621|Secondary|Maximum Change From Baseline in Hemoglobin During the Double-blind Period for Participants Who Became Red Blood Cell (RBC) Transfusion Independent for at Least 182 Days|For participants who became RBC transfusion independent for at least 182 days during the double-blind study period, the mean maximum change from baseline in hemoglobin is summarized.|Baseline, up to 52 weeks|The modified intent-to-treat (mITT) population included all participants with centrally-confirmed Low- or Int-1-risk MDS with del 5q[31] and documented RBC transfusion dependence who had received ≥ 1 dose of study drug. MITT participants who were transfusion independent for >= 182 study days are included.||g/dL||Standard Deviation|Mean
711766|NCT00179621|Secondary|Duration of Red Blood Cell (RBC) Transfusion Independence for Participants Who Became RBC Transfusion Independent for at Least 182 Days|Mean number of weeks that participants who achieved RBC transfusion independence for at least 182 days were able to maintain RBC transfusion independence. Both double-blind and open-label periods are included.|up to 3 years|The modified intent-to-treat (mITT) population included all participants who achieved RBC transfusion independence for at least 182 days.||Weeks||Standard Deviation|Mean
711767|NCT00179621|Secondary|Participants Who Achieved Red Blood Cell (RBC) Transfusion Independence for 56 Days|Count of study participants who had no RBC transfusions during any 56 or more consecutive study days during the double-blind period.|Up to 52 weeks|The modified intent-to-treat (mITT) population included all participants with centrally-confirmed Low- or Int-1-risk MDS with del 5q[31] and documented RBC transfusion dependence who had received ≥ 1 dose of study drug.||Participants|||Number
712279|NCT00189423|Secondary|Survival to Hospital Discharge||cardiac arrest to hospital discharge|||patients|||Number
711769|NCT00179647|Primary|Overall Incidence of Adverse Events|Data from all subjects who received any study drug were included in the analysis. Adverse events were classified using the Medical Dictionary for Regulatory Activities (MedDRA) classification system. A subject having the same event more than once was counted only once. Adverse events were summarized by worst NCI (National Cancer Institute) CTCAE (Common Terminology Criteria for Adverse Events) VERSION 3.0 grade. Incidence was defined as the number of subjects who experienced an adverse event within their period of participation in this study.|Median time-on-study=18.3 weeks|Subjects who received study drug||Participants|||Number
711770|NCT00179647|Primary|Incidence of Adverse Events Summarized by System Organ Class, Preferred Term, Severity, Seriousness, and Relationship to Treatment.|Data from all subjects who received any study drug were included in the analysis. Adverse events were classified using the Medical Dictionary for Regulatory Activities (MedDRA) classification system. A subject having the same event more than once was counted only once. Adverse events were summarized by worst NCI (National Cancer Institute) CTCAE (Common Terminology Criteria for Adverse Events) VERSION 3.0 grade. Incidence was defined as the number of subjects who experienced an adverse event within their period of participation in this study.|Median time-on-study=18.3 weeks||||||
711771|NCT00179660|Secondary|Number of Participants With Adverse Events (AEs)|"The Investigator determined the relationship between the administration of study drug and the occurrence of an AE as suspected if the temporal relationship of the adverse event to study drug administration made a causal relationship possible, and other drugs, therapeutic interventions, or underlying conditions did not provide a sufficient explanation for the observed event.
The Investigator graded the severity of AEs according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) criteria and the following scale:
Grade 1 = Mild
Grade 2 = Moderate
Grade 3 = Severe
Grade 4 = Life threatening
Grade 5 = Death
A Serious AE is defined as any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or constitutes an important medical event."|From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 15.2 months.|Safety Population, which includes all participants who received at least one dose of study drug.||participants|||Number
711772|NCT00179660|Secondary|Progression-free Survival|"Progression-free survival was defined as the time from the start of study drug therapy to the first observation of disease progression or death due to any cause, whichever came first.
Participants who withdrew for any reason or received another NHL therapy including stem cell transplantation without documented progressive disease were censored on the date of their last adequate response assessment indicating no progression (or last adequate assessment prior to receiving other NHL therapy). Participants who were still active without progressive disease at the time of the data cut-off date were censored on the date of their last adequate response assessment."|From enrollment through study completion. Median duration on study was 3.7 months, with a maximum of 32.5 months.|Intent to treat population||months||95% Confidence Interval|Median
711773|NCT00179660|Secondary|Duration of Tumor Control|The duration of tumor control was calculated as the time from the first response assessment demonstrating at least stable disease to the first documentation of progressive disease or death due to NHL. For participants without documentation of progression, the duration of response was censored at the last date of tumor assessment indicating no progression. Median was based on the Kaplan-Meier estimate.|From enrollment through study completion. Median duration on study was 3.7 months, with a maximum of 32.5 months.|Intent to treat population with tumor control (CR, CRu, PR or SD).||months||95% Confidence Interval|Median
711774|NCT00179660|Secondary|Duration of Response|The duration of response was calculated as the first response assessment demonstrating evidence of at least a partial response to the first documentation of progressive disease (as determined by computed tomography scan) or death due to NHL, whichever occurred first. For participants without documentation of progression, the duration of response was censored at the last date of tumor assessment indicating no progression. Median was based on the Kaplan-Meier estimate.|From enrollment through study completion. Median duration on study was 3.7 months, with a maximum of 32.5 months.|Intent to treat population with a response = CR, CRu or PR.||months||95% Confidence Interval|Median
711775|NCT00179660|Secondary|Percentage of Participants With Tumor Control|"Tumor control was defined as participants with a complete response, unconfirmed complete response, partial response or stable disease (SD), assessed using the International Workshop Lymphoma Response Criteria (IWLRC) and based on best responses as determined by the investigator.
SD was defined as a response less than a PR (see above) but not Progressive Disease (PD).
PD was defined as
≥ 50 % increase from nadir in the SPD of any previously identified abnormal node for partial responders or non-responders.
Appearance of any new lesion during or at the end of therapy."|From enrollment through study completion. Median duration on study was 3.7 months, with a maximum of 32.5 months.|Intent-to-treat (ITT) population. Patients who dropped out without having a response assessment or who had a response after they had received other anti-cancer treatments were considered non-responders.||percentage of participants||95% Confidence Interval|Number
711776|NCT00179660|Primary|Percentage of Participants With Response|"Response was defined as participants with a complete response (CR), unconfirmed complete response (Cru) or partial response (PR), assessed using the International Workshop Lymphoma Response Criteria (IWLRC) and based on best responses as determined by the investigator.
CR: Complete disappearance of all detectable clinical and radiographic evidence of disease, disappearance of any disease-related symptoms, and normalization of biochemical abnormalities.
Cru: Criteria for CR above but with 1 or more of the following:
A residual lymph node mass > 1.5 cm in greatest transverse diameter that has regressed by more than 75% in the sum of the products of diameters (SPD)
Indeterminate bone marrow (increased number or size of aggregates without cytologic or architectural atypia).
PR: 50% decrease in SPD of the 6 largest dominant nodes or nodal masses. No increase in the size of other nodes, liver, or spleen. Splenic and hepatic nodules must regress by at least 50% in the SPD."|From enrollment through study completion. Median duration on study was 3.7 months, with a maximum of 32.5 months.|Intent-to-treat (ITT) population, which included all enrolled patients who received at least 1 dose of study drug. Patients who dropped out without having a response assessment or who had a response after they had received other anti-cancer treatments were considered non-responders.||percentage of participants||95% Confidence Interval|Number
713259|NCT00211510|Secondary|Glucose Sensor Accuracy as Measured in the 722 Group|Percent comparative sensor glucose reading to blood glucose meter in agreement within +/- 20% (Clark Error Grid zone A + zone B).|Baseline and 26 weeks|||percent of agreement|||Number
711777|NCT00179673|Secondary|Number of Participants With Adverse Events (AEs)|"The Investigator determined the relationship between the administration of study drug and the occurrence of an AE as suspected if the temporal relationship of the adverse event to study drug administration made a causal relationship possible, and other drugs, therapeutic interventions, or underlying conditions did not provide a sufficient explanation for the observed event.
The Investigator graded the severity of AEs according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) criteria and the following scale:
Grade 1 = Mild
Grade 2 = Moderate
Grade 3 = Severe
Grade 4 = Life threatening
Grade 5 = Death
A Serious AE is defined as any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or constitutes an important medical event."|From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months.|Safety Population, which includes all participants who received at least one dose of study drug.||participants|||Number
711778|NCT00179673|Secondary|Progression Free Survival (PFS)|Progression-free survival was defined as the time from the start of study drug therapy to the first observation of disease progression or death due to any cause, whichever came first. Participants who withdrew for any reason or received another NHL therapy including stem cell transplantation without documented progressive disease were censored on the date of their last adequate response assessment indicating no progression (or last adequate assessment prior to receiving other NHL therapy). Participants who were still active without progressive disease at the time of the data cut-off date were censored on the date of their last adequate response assessment.|From enrollment through study completion. Median duration on study was 4.4 months with a maximum of 32 months|Intent to treat population||months||95% Confidence Interval|Median
711779|NCT00179673|Secondary|The Duration of Response|The duration of response was calculated as the first response assessment demonstrating evidence of at least a partial response to the first documentation of progressive disease (as determined by computed tomography scan) or death due to NHL, whichever occurred first. For participants without documentation of progression, the duration of response was censored at the last date of tumor assessment indicating no progression. Median was based on the Kaplan-Meier estimate.|From enrollment through study completion. Median duration on study was 4.4 months with a maximum of 32 months|Includes participants with a response to treatment||months||95% Confidence Interval|Median
711780|NCT00179673|Secondary|Percentage of Participants With Tumor Control|"Tumor control was defined as participants with a complete response, unconfirmed complete response, partial response or stable disease (SD), assessed using the International Workshop Lymphoma Response Criteria (IWLRC) and based on best responses as determined by the investigator.
SD was defined as a response less than a PR (see above) but not Progressive Disease (PD).
PD was defined as
≥ 50 % increase from nadir in the SPD of any previously identified abnormal node for partial responders or non-responders.
Appearance of any new lesion during or at the end of therapy."|From enrollment through study completion. Median duration on study was 4.4 months with a maximum of 32 months|Intent-to-treat (ITT) population. Patients who dropped out without having a response assessment or who had a response after they had received other anti-cancer treatments were considered non-responders||percentage of participants||95% Confidence Interval|Number
711781|NCT00179673|Primary|Percentage of Participants With Response|"Response was defined as participants with a complete response (CR), unconfirmed complete response (Cru) or partial response (PR), assessed using the International Workshop Lymphoma Response Criteria (IWLRC) and based on best responses as determined by the investigator. CR: Complete disappearance of all detectable clinical and radiographic evidence of disease, disappearance of any disease-related symptoms, and normalization of biochemical abnormalities.
Cru: Criteria for CR above but with 1 or more of the following:
A residual lymph node mass > 1.5 cm in greatest transverse diameter that has regressed by more than 75% in the sum of the products of diameters (SPD)
Indeterminate bone marrow (increased number or size of aggregates without cytologic or architectural atypia).
PR: ≥ 50% decrease in SPD of the 6 largest dominant nodes or nodal masses. No increase in the size of other nodes, liver, or spleen. Splenic and hepatic nodules must regress by at least 50% in the SPD."|From enrollment through study completion. Median duration on study was 4.4 months with a maximum of 32 months|Intent-to-treat (ITT) population, which included all enrolled patients who received at least 1 dose of study drug. Patients who dropped out without having a response assessment or who had a response after they had received other anti-cancer treatments were considered non-responders.||percentage of participants||95% Confidence Interval|Number
711782|NCT00179959|Primary|Change in Eczema Area and Severity Index (EASI)Scores According to Location|The proportion of affected body surface area (BSA) was estimated from 4 designated body regions(head/neck, upper limbs, trunk, and lower limbs),and the Physician’s Assessment of Individual Signs was determined for each region by grading signs of AD on a 4-point scale. Both the proportion of affected BSA and the Physician’s Assessment of Individual Signs score were used to calculate the EASI score,a validated composite score that ranges from 0 (clear) to 72 (very severe).|Baseline and 3 months|Analysis was per protocol.||Change in EASI Score||Standard Deviation|Mean
711783|NCT00186446|Primary|Can Depression and Smoking Cessation be Treated Simultaneously|This was measured by the drop out rate during the study.|Dropouts over course of study|Number dropped out of the study||Participants|||Count of Participants
711784|NCT00186446|Primary|Cessation of Smoking|Carbon monoxide breath level of below 9PPM which indicates cessation of smoking.|Week 10|Carbon monoxide levels available on 8 subjects at week 10.||Participants|||Count of Participants
711785|NCT00186446|Primary|Hamilton Depression Scale Score|Utilized the Hamilton Depression Rating Scale, 21-item version to assess depressive symptoms, with a range of 0-63. Higher values indicate more depression. % Change in depression score from baseline to week 10. Negative values indicate a reduction in depression.|baseline to week 10|9 patients did not complete the study and we used last observation carried forward||percentage of change in depression||Standard Deviation|Mean
711812|NCT00190684|Primary|Change From Baseline to 5 Year Endpoint in Body Weight||baseline, 5 years|The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.||kilograms (kg)||Standard Deviation|Mean
711813|NCT00190684|Primary|Change From Baseline to 5 Year Endpoint in Pulse||baseline, 5 years|The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.||beats per minute (bpm)||Standard Deviation|Mean
711786|NCT00186485|Secondary|Clinical Global Impression - Severity; Baseline to End of Week 4|The Clinical Global Impression of Severity (CGI-S) is a measure of depression severity and disability based on the clinicians overall impression of the severity of depression based on the patients response to open ended questions and self report of the presence and severity of the symptoms and level of disability found in depression. The CGI-S assesses the severity of illness (depression) and is scored from 1 (well, not at all ill) to 7 (among the most severely ill patients); a decrease in the CGI-S score reflects a reduction of the symptoms and disability due to depression. The scores are from Baseline and End of Week 4|4 weeks|Subjects received 4 weeks of right sided dorsolateral prefrontal cortex 1Hz TMS, last observation carried forward||units on a scale||Standard Deviation|Mean
711787|NCT00186485|Secondary|Beck Depression Inventory Score; Baseline to End of Week 4|The Beck Depression Inventory Scale (BDI) measures the severity of depression based on the patients response to 21 questions on the presence and severity of the symptoms found in depression. The severity of a symptom is scored from 0 (not present) to 3 (most severe); total scores range from 0 (no depressive symptoms), to 63 (very severe depression). A decrease in the score reflects a reduction of the severity of depression.The scores are from Baseline and End of Week 4|4 weeks|Subjects received 4 weeks of right sided dorsolateral prefrontal cortex 1Hz TMS, last observation carried forward||units on a scale||Standard Deviation|Mean
711788|NCT00186485|Primary|Hamilton Depression Rating Scale (HDRS) -17 Item; Baseline to End of Week 4|The HDRS - 17 is a scale that measures the severity of depression based on the patients response to 17 questions on the presence and severity of the symptoms found in depression. The severity of a symptom is scored from 0 (not present) to 4 (most severe); total scores range from 0 (no depressive symptoms), to 68 (very severe depression). A decrease in the HDRS score reflects a reduction in depression severity.The scores are Baseline and End of Week 4|4 weeks|Subjects received 4 weeks of right sided dorsolateral prefrontal cortex 1Hz TMS, last observation carried forward||units on a scale||Standard Deviation|Mean
711789|NCT00186537|Primary|Pre- and Post-Intervention HDL Cholesterol Levels|Compare the change in mean HDL Cholesterol levels between groups after the interventions|Baseline, 12 weeks|HDL Cholesterol||mg/dL||Standard Deviation|Mean
711790|NCT00186537|Primary|Pre- and Post-Intervention LDL Cholesterol Levels|Compare the change in mean LDL Cholesterol levels between groups after the interventions|Baseline, 12 weeks|LDL cholesterol||mg/dL||Standard Deviation|Mean
711791|NCT00186537|Primary|Pre- and Post-Intervention Triglyceride Levels|Compare the change in mean triglyceride levels between groups after the interventions|Baseline, 12 weeks|Triglycerides||mg/dL||Standard Deviation|Mean
711792|NCT00190671|Secondary|Pharmacokinetics - Half-Life (t½)|The half-life associated with the terminal elimination rate constant.|cycle 1 (Day 1: <1 min prior to end of pemetrexed infusion; 1/2, 1, 1.5, 2, 3, 4, 6, 8, 24, 48, 72 hours after start of pemetrexed infusion)|Number of participants included in the pharmacokinetic analyses.||hours||Full Range|Geometric Mean
711793|NCT00190671|Secondary|Pharmacokinetics - Volume of Distribution|Central volume (V1) and peripheral volume (V2) of distribution.|cycle 1 (Day 1: <1 min prior to end of pemetrexed infusion; 1/2, 1, 1.5, 2, 3, 4, 6, 8, 24, 48, 72 hours after start of pemetrexed infusion)|Number of participants included in the pharmacokinetic analyses.||Liters||Full Range|Geometric Mean
711794|NCT00190671|Secondary|Pharmacokinetics - Clearance (CL)|Total body clearance of drug calculated after intravenous administration.|cycle 1 (Day 1: <1 min prior to end of pemetrexed infusion; 1/2, 1, 1.5, 2, 3, 4, 6, 8, 24, 48, 72 hours after start of pemetrexed infusion)|Number of participants included in the pharmacokinetic analyses.||milliliters per minute||Full Range|Geometric Mean
711795|NCT00190671|Secondary|Pharmacokinetics - Area Under the Curve (AUC)|Area under the gemcitabine concentration-time curve from zero to last quantifiable concentration [AUC(0-t)] was calculated by combination of linear and logarithmic trapezoidal methods. Linear trapezoidal method was employed up to tmax (time to reach maximal concentration), and then log trapezoidal method was used for those data after tmax.|cycle 1 (Day 1: <1 min prior to end of pemetrexed infusion; 1/2, 1, 1.5, 2, 3, 4, 6, 8, 24, 48, 72 hours after start of pemetrexed infusion)|Number of participants included in the pharmacokinetic analyses.||hour times microgram per milliliter||Full Range|Geometric Mean
711796|NCT00190671|Secondary|Pharmacokinetics - Maximum Observed Drug Concentration (Cmax)||cycle 1 (Day 1: <1 min prior to end of pemetrexed infusion; 1/2, 1, 1.5, 2, 3, 4, 6, 8, 24, 48, 72 hours after start of pemetrexed infusion)|Number of participants included in the pharmacokinetic analyses.||micrograms per milliliters||Full Range|Geometric Mean
711797|NCT00190671|Secondary|Progression Free Survival|Defined as date of first treatment dose to first date of progressive disease or death from any cause. For patients not known to have died as of data cutoff date and who did not have progressive disease, the progression free survival date was censored at last contact date.|baseline to measured progressive disease|All randomized participants in the Phase 2 portion of the trial (enrollment in 600mg/m2 arm stopped during Phase 1 and was not continued in Phase 2). The Progression Free Survival date was censored for 22 (35.07%) participants.||months||95% Confidence Interval|Median
711798|NCT00190671|Secondary|Time to Progressive Disease|Time to progressive disease was defined as the time from the date of the first treatment dose to the first date of progressive disease or death from study disease.|baseline to measured progressive disease|All randomized participants in the Phase 2 portion of the trial (enrollment in 600mg/m2 arm stopped during Phase 1 and was not continued in Phase 2). Time to disease progression was censored for 26 (42.6%) participants.||months||95% Confidence Interval|Median
711799|NCT00190671|Primary|Best Tumor Response|Tumor response was assessed using radiological imaging, which was repeated every 6 weeks prior to every other cycle. Confirmation of response was to occur no less than 4 weeks (28 days) after the first evidence of response.|baseline to measured progressive disease|Number of randomized participants.||participants|||Number
711800|NCT00190684|Primary|Number of Participants in Each Tanner Stage (Pubic Hair) by Age Group|"Tanner Stage:
I: no pubic hair at all (prepubertal Dominic state) II: small amount of long, downy hair with slight pigmentation at the base of the penis and scrotum (males) or on the labia majora (females) III: hair becomes more coarse and curly, and begins to extend laterally IV: adult-like hair quality, extending across pubis but sparing medial thighs V: hair extends to medial surface of the thighs
Age Groups:
age<11.0 (female) and age<12 (male)
11=<age<12 (female) or 12<=age<13 (male)
12=<age<15 (female) or 13=<age<15 (male)
age>=15 (female and male)"|1 year through 5 years|The analysis population is defined as patients with at least two Tanner measurements.||participants|||Number
711801|NCT00190684|Primary|Number of Participants With Abnormal Laboratory Analytes During the Study|Standard reference ranges from Covance Laboratories were used in the determination of abnormal high and low values based on age and gender, where appropriate. Aspartate aminotransferase (AST); serum glutamic oxaloacetic transaminase (SGOT); units/liter (U/L); alanine aminotransferase (ALT); serum glutamic pyruvic transaminase (SGPT); millimoles/liter (mmol/L); grams/liter (g/L); micromoles/liter (umol/L); millimoles/liter-iron (mmol/L-Fe); trillion/liter (TI/L)or 10^12 units/liter; Giga/liter (GI/L)or 10^9 units/liter; femtoliters (fL); urinalysis (UA)|baseline through 5 years|The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.||participants|||Number
711802|NCT00190684|Primary|Number of Patients Meeting CPMP Categorical QTc Interval Criteria Part II (Interpretation at Baseline and Endpoint)|QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate. A corrected QT interval (QTc) has been corrected in order to aid interpretation. QTbz is the QT interval using Bazett's correction formula. QTfr is the QT interval using Fridericia's correction formula. QTdat is the QT interval using a data specific correction method for children. For Males: Normal is <430 ms, Borderline is >=430 ms and <450 ms, Prolonged is >=450 ms. For Females: Normal is <450 ms, Borderline is >=450 ms and <470 ms, Prolonged is >=470 ms.|baseline through 5 years|The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.||participants|||Number
711803|NCT00190684|Secondary|Change From Baseline to 5 Year Endpoint in the Stroop Word Color Test|Only patients who took the Stroop Color Word Test in a previous atomoxetine study were required to complete the Stroop in this study. Stroop measures inhibition of dominant response and interference control. Patients were given tasks of recognition (colors), reading (where a word represents a color), and interference (reading words written in different colors). There were 100 items for each of the three categories and if they made it through 100 words with time remaining, they would repeat the list. Only a small number of patients had Stroop tests in this study, so no analysis was done.|baseline, 5 years|There were not enough participants with prior Stroop Word Color tests to analyze the data.||number of correct answers||Standard Deviation|Mean
711804|NCT00190684|Secondary|Change From Baseline to 5 Year Endpoint in Conners' Parent Rating Scale-Revised: Short Form (CPRS-R:S) Subscale Scores|A 27-item rating scale (0 [not at all/never] to 3 [very much true/very often]) completed by the parent to assess problem behaviors related to ADHD. Subscales: Oppositional, Cognitive Problems, Hyperactivity, and ADHD Index. Subscale total scores range from 0 to 18 for all subscales except ADHD Index which ranges from 0 to 36.|baseline, 5 years|The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.||units on a scale||Standard Deviation|Mean
711805|NCT00190684|Secondary|Change From Baseline to 5 Year Endpoint in Clinical Global Impressions-Attention-Deficit/Hyperactivity Disorder-Severity (CGI-ADHD-S) Score|Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).|baseline, 5 years|The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.||units on a scale||Standard Deviation|Mean
711806|NCT00190684|Secondary|Change From Baseline to 5 Year Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score and Subscale Scores|Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of ADHD. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. Hyperactive/Impulsive and Inattention Subscales consisted of 9 items each, for total subscale score range of 0 to 27. ADHD Index Subscale consisted of 12 items, for total score range of 0 to 36.|baseline, 5 years|The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.||units on a scale||Standard Deviation|Mean
711807|NCT00190684|Primary|Number of Patients Meeting Committee for Proprietary Medicinal Products (CPMP) Categorical QTc Interval Criteria Part I (Numerical Increase)|QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate. A corrected QT interval (QTc) has been corrected in order to aid interpretation. QTbz is the QT interval using Bazett's correction formula. QTfr is the QT interval using Fridericia's correction formula. QTdat is the QT interval using a data specific correction method for children.|baseline through 5 years|The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.||participants|||Number
711808|NCT00190684|Primary|Change From Baseline to 5 Year Endpoint in Heart Rate|Patients were assessed for changes in heart rate using electrocardiogram.|baseline, 5 years|The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.||beats per minute (bpm)||Standard Deviation|Mean
711809|NCT00190684|Primary|Change From Baseline to 5 Year Endpoint in Electrocardiogram (ECG)|Patients were assessed for changes in ECG. The RR interval is the time duration between two consecutive R waves of the ECG. The QRS interval is the beginning of Q to the end of the S wave. The QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate. A corrected QT interval (QTc) has been corrected in order to aid interpretation. QTbz is the QT interval using Bazett's correction formula. QTfr is the QT interval using Fridericia's correction formula.QTdat is the QT interval using a data specific correction method for children.|baseline, 5 years|The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.||milliseconds (msec)||Standard Deviation|Mean
711810|NCT00190684|Primary|Change From Baseline to 5 Year Endpoint in Weight, Height, and Body Mass Index (BMI) Percentile Stratified by Baseline Quartile|Patients were assessed for changes in weight, height, and BMI. BMI is an estimate of body fat based on body weight divided by height squared.|baseline, 5 years|The number of participants analyzed was defined as all patients with a baseline and 5 year endpoint measurement.||percentiles||Standard Deviation|Mean
711811|NCT00190684|Primary|Change From Baseline to 5 Year Endpoint in Height||baseline, 5 years|The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.||centimeters (cm)||Standard Deviation|Mean
711815|NCT00190684|Primary|Categorical Changes in Vital Signs (Blood Pressure [BP], Pulse, Weight, Temperature) During the Study|Vital signs were assesed categorically using the term high for BP, high and low for pulse and temperature, or decreased for weight. For BP, high was an increase to a value above the 95th percentile of the National Institute of Health (NIH) values. For pulse, high was an increase of at least 25 beats per minute to at least 110, and low was a decrease of at least 20 beats per minute to at most 65 beats per minute. For temperature, high was an increase of at least 1 to 37.7 and low was a decrease of at least 1.3 to at most 35.6. Decrease in weight was marked by a reduction of at least 3.5%.|Baseline through 5 years|For each vital sign, the number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug. Number of subject analyzed for each vital sign is provided.||participants|||Number
711816|NCT00190749|Secondary|Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Lipoprotein Subclasses|Changes in lipid parameters and subclass lipoproteins last observation carried forward (LOCF) mean change from baseline. HDL=High Density Lipoprotein, IDL=Intermdiate Density Lipoprotein, LDL=Low Density Lipoprotein, VLDL=Very Low Density Lipoprotein.|baseline and 12 weeks.|Mean change from baseline, all randomized patients, double-blind treatment period||nanomoles per Liter (nmol/L)||Standard Deviation|Mean
711817|NCT00190749|Secondary|Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Triglycerides|Changes in fasting lipid parameters including triglycerides last observation carried forward (LOCF) mean change from baseline|baseline and 12 weeks|Change from baseline to last observation, all randomized patients, double-blind treatment period||millimoles per Liter (mmol/L)||Standard Deviation|Mean
711818|NCT00190749|Secondary|Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including High Density Lipoprotein (HDL)|Fasting lipid parameters including HDL change from baseline to last observation carried forward.|baseline and 12 weeks|Change from baseline to last observation, all randomized patients, double-blind treatment period||millimoles per Liter (mmol/L)||Standard Deviation|Mean
711819|NCT00190749|Secondary|Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Direct Low Density Lipoprotein (LDL)|Fasting lipid parameters including Direct LDL, change from baseline to last observation carried forward.|baseline and 12 weeks|Change from baseline to last observation, all randomized patients, double-blind treatment period||millimoles per Liter (mmol/L)||Standard Deviation|Mean
711820|NCT00190749|Secondary|Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Total Cholesterol|Fasting lipid parameters including total cholesterol, change from baseline to last observation carried forward.|baseline and 12 weeks|Change from baseline to last observation, all randomized patients, double-blind treatment period||millimoles per Liter (mmol/L)||Standard Deviation|Mean
711821|NCT00190749|Secondary|Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores|Eating Behavior Assessment Scale is a 9-item self-rated tool used to evaluate appetite and eating behaviors. Item scores range from 0 (never) to 4 (always).|baseline and 12 weeks|Change from baseline to last observation carried forward, all randomized patients, double-blind treatment period||units on a scale||Standard Deviation|Mean
711822|NCT00190749|Secondary|Change From Baseline to 12 Week Endpoint in Simpson Angus Scale Scores|Measures neuroleptic-induced parkinsonism. Total score of Simpson Angus Scale consists of the sum of 10 items rated on a 5-point severity scale where 0=normal and 4=extreme. The total score ranges from 0 to 40.|baseline and 12 weeks|Change from baseline to last observation carried forward, all randomized patients, double-blind treatment period||units on a scale||Standard Deviation|Mean
711823|NCT00190749|Secondary|Change From Baseline to 12 Week Endpoint in Barnes Akathisia Rating Scale (BARS) Scores|The BARS is a 4-item instrument that evaluates akathisia associated with use of antipsychotic medications. Item 4 is the Global clinical assessment and is rated 0 to 5 (0 = absent, 5 = severe). The other 3 items (related to objective and subjective assessments) are not used for these analyses.|baseline and 12 weeks|Change from baseline to last observation carried forward, all randomized patients, double-blind treatment period||units on a scale||Standard Deviation|Mean
711824|NCT00190749|Secondary|Change From Baseline to 12 Week Endpoint in Abnormal Involuntary Movement Scale Scores|A 12-item instrument assesses observed abnormal movements in different parts of body. Seven items are scored in a 5-point scale (0 = none/normal, 4 = severe) which evaluates abnormal movements in 3 main anatomic areas (orofacial area, extremities, and trunk). Total scores range from 0 to 28. Five collected elements are not used in this total.|baseline and 12 weeks|Change from baseline to last observation carried forward, all randomized patients, double-blind treatment period||units on a scale||Standard Deviation|Mean
711825|NCT00190749|Secondary|Change From Baseline to 12 Week Endpoint in Clinical Global Impression - Severity of Illness Scores|Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients.|baseline and 12 weeks|Change from baseline to last observation carried forward, all randomized patients, double-blind treatment period||units on a scale||Standard Deviation|Mean
711826|NCT00190749|Secondary|Change From Baseline to 12 Week Endpoint in Brief Psychiatric Rating Scale (BPRS) Scores|Brief Psychiatric Rating Scale (BPRS) is an 18-item clinician-administered scale used to assess the degree of severity of a subject's general psychopathological symptoms. Item scores range from 0 (not present) to 6 (extremely severe). Total Scores range from 0 to 108; Positive Subscale Scores range from 0 to 24. Negative Subscale Scores range from 0 to 18. Anxiety-Depression Subscale Scores range from 0 to 24.|baseline and 12 weeks|BPRS Total and Subscale Scores-Change from Baseline to Last Observation Carried Forward, all randomized patients, double-blind treatment period||units on a scale||Standard Deviation|Mean
711827|NCT00190749|Secondary|Change From Baseline to 12 Week Endpoint in the Ratio of the Visceral Fat Area to the Subcutaneous Fat Area|Ratio of the visceral fat area to the subcutaneous fat area change from baseline to last observation carried forward, all randomized patients, double-blind treatment period|baseline and 12 weeks|Abdominal CT scan change from baseline to last observation of randomized patients who completed the baseline and endpoint clamps with both diet stabilizations||ratio in square centimeters (cm2)||Standard Deviation|Mean
711828|NCT00190749|Secondary|Change From Baseline to 12 Week Endpoint in Subcutaneous Fat Area|Subcutaneous fat area change from baseline to last observation carried forward, all randomized patients, double-blind treatment period|baseline and 12 weeks|Abdominal CT scan change from baseline to last observation for randomized patients who completed baseline and endpoint clamps with both diet stabilizations||square centimeters (cm2)||Standard Deviation|Mean
711829|NCT00190749|Secondary|Change From Baseline to 12 Week Endpoint in Visceral Fat Area|Visceral fat area change from baseline to last observation carried forward, all randomized patients, double-blind treatment period|baseline and 12 weeks|Abdominal CT scan of changes from baseline to last observation of randomized patients who completed baseline and endpoint clamps with both diet stabilizations||square centimeters (cm2)||Standard Deviation|Mean
711830|NCT00190749|Secondary|Change From Baseline to 12 Week Endpoint in Waist Circumference|Waist circumference change from baseline to last observation carried forward.|baseline and 12 weeks|Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.||centimeters||Standard Deviation|Mean
711831|NCT00190749|Secondary|Change From Baseline to 12 Week Endpoint in Weight|Weight change from baseline to last visit (last observation carried forward)|baseline and 12 weeks|Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.||kilograms||Standard Deviation|Mean
711832|NCT00190749|Secondary|Change From Baseline to 12 Week Endpoint in Body Mass Index|Within-and Between-Treatment Group changes in Body Mass Index from baseline to last observation carried forward.|baseline and 12 weeks|Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations||kilograms per square meter (kg/m2)||Standard Deviation|Mean
711833|NCT00190749|Secondary|Pairwise Correlations Between Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Eating Behavior Assessment Scale Scores.|Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in Eating Behavior Assessment Scale scores|12 weeks|Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.||correlation|||Number
711834|NCT00190749|Secondary|Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Subcutaneous Fat Area.|Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in subcutaneous fat area|12 weeks|Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.||correlation|||Number
711835|NCT00190749|Secondary|Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Visceral Fat Area.|Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in visceral fat area|12 weeks|Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations||correlation|||Number
711836|NCT00190749|Secondary|Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Waist Circumference.|Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in waist circumference|12 weeks|Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations||correlation|||Number
711837|NCT00190749|Secondary|Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in the Simpson Angus Scale Scores.|Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in the Simpson Angus Scale scores|12 weeks|Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.||correlation|||Number
711838|NCT00190749|Secondary|Pairwise Correlation Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Barnes Akathisia Scale Scores.|Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in Barnes Akathisia scores|12 weeks|Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.||correlation|||Number
711839|NCT00190749|Secondary|Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Abnormal Involuntary Movement Scale Scores.|Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in Abnormal Involuntary Movement Scale scores|12 weeks|Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.||correlation|||Number
711840|NCT00190749|Secondary|Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Clinical Global Impression - Severity of Illness Scale Scores.|Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in Clinical Global Impression-Severity of Illness scale scores|12 weeks|Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.||correlation|||Number
711841|NCT00190749|Secondary|Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Brief Psychiatric Rating Scale Scores.|Normalized insulin senstivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in Brief Psychiatric Rating Scale scores|12 weeks|Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.||correlation|||Number
711842|NCT00190749|Secondary|Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Ratio of Visceral Fat Area to the Subcutaneous Fat Area.|Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in ratio of visceral far area to subcutaneous fat area|12 weeks|Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.||correlation|||Number
711843|NCT00190749|Secondary|Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Body Mass Index (BMI)|Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in BMI|12 weeks|Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.||correlation|||Number
711844|NCT00190749|Secondary|Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Weight.|Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in weight|12 weeks|Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.||correlation|||Number
711888|NCT00191113|Secondary|Maximum Glycosylated Hemoglobin|Maximum measured value over addendum. In special cases an additional measurement is taken at 2 years.|At start and through end of 4-year addendum (up to an additional 2 years)|Patients with addendum data who were followed for at least 4 years without growth hormone treatment (and never received growth hormone) or who received growth hormone for at least 4 years.||percent (%)||Standard Deviation|Mean
711845|NCT00190749|Primary|Change in Baseline to Last Observation In Normalized Insulin Sensitivity Index at Low Insulin Phase Using Change in Weight as a Covariate|Normalized insulin sensitivity index (Mffm/I) was defined as the ratio of whole body glucose disposal rate normalized to fat-free mass (Mffm) divided by the plasma insulin concentration (I) during steady-state conditions of the clamp procedure. Units:[(mg glucose)*min*mL] / [(kg fat free body mass)*(micro IU insulin)]|baseline and 12 weeks|N=number of patients with a baseline and post-baseline result within each treatment group for Mffm/I and weight.||Mffm/I||Standard Deviation|Mean
711846|NCT00190775|Secondary|Change From Baseline to After a 2-Week Titration Period Beginning at Week 24 and Ending at Week 26 in the CAARS-Inv:SV Total Attention Deficit Hyperactivity Disorder (ADHD) Symptoms and Subscale Scores: Dosing Titration Strategy After Placebo|30-item scale containing 3 subscales: inattention (9 items), hyperactivity/ impulsivity (9 items), and ADHD Index (12 items). Each item is scored 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Total ADHD symptoms score=sum of the inattention and hyperactivity/impulsivity subscales. Total Scores range from 0-54 (range of 0-27 for the inattention and hyperactivity subscales; 0-36 for the ADHD Index) with higher scores indicating more impaired participants. The scale was administered by a physician/PhD at the investigative site.|Baseline, after 2-week titration period beginning at Week 24|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.||Units on a scale||Standard Deviation|Mean
711847|NCT00190775|Secondary|Change From Baseline to 2 Weeks of Titration in the CAARS-Inv:SV Total Attention Deficit Hyperactivity Disorder (ADHD) Symptoms and Subscale Scores|30-item scale containing 3 subscales: inattention (9 items), hyperactivity/ impulsivity (9 items), and ADHD Index (12 items). Each item is scored 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Total ADHD symptoms score=sum of the inattention and hyperactivity/impulsivity subscales. Total Scores range from 0-54 (range of 0-27 for the inattention and hyperactivity subscales; 0-36 for the ADHD Index) with higher scores indicating more impaired participants. The scale was administered by a physician/PhD at the investigative site.|Baseline, 2 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.||Units on a scale||Standard Deviation|Mean
711848|NCT00190775|Secondary|Change From Baseline to 1 Week of Titration in the CAARS-Inv:SV Total Attention Deficit Hyperactivity Disorder (ADHD) Symptoms and Subscale Scores|30-item scale containing 3 subscales: inattention (9 items), hyperactivity/ impulsivity (9 items), and ADHD Index (12 items). Each item is scored 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Total ADHD symptoms score=sum of the inattention and hyperactivity/impulsivity subscales. Total Scores range from 0-54 (range of 0-27 for the inattention and hyperactivity subscales; 0-36 for the ADHD Index) with higher scores indicating more impaired participants. The scale was administered by a physician/PhD at the investigative site.|Baseline, 1 week|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.||Units on a scale||Standard Deviation|Mean
711849|NCT00190775|Secondary|Change From Baseline to 12 and 24 Weeks in the State-Trait Anxiety Inventories (STAI)|Self-report scale completed by the participant. Separate scales measure state (20 items) and trait (20 items) anxiety. The participant reports how they feel “right now at this moment” for state anxiety and how they “generally” feel for trait anxiety. The “state” items are scored as: 1 (not at all), 2 (somewhat true), 3 (moderately true), 4 (very true). The “trait” items are scored as: 1 (almost never), 2 (sometimes), 3 (often), 4 (almost always). Scores range from 4-80 for each scale. Higher scores indicate more impaired participants.|Baseline, 12 weeks, 24 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.||Units on a scale||Standard Deviation|Mean
711850|NCT00190775|Secondary|Change From Baseline to 12 and 24 Weeks in the Montgomery-Asberg Depression Rating Scale Total Score (MADRS)|The MADRS is an investigator administered rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline 12 weeks, 24 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.||Units on a scale||Standard Deviation|Mean
711851|NCT00190775|Secondary|Change From Baseline to 8 and 24 Weeks in the Clinical Global Improvement Attention Deficit Hyperactivity Disorder Severity (CGI-ADHD-S)|The CGI-ADHD-S is a single-item rating of the clinician’s assessment of the severity of ADHD symptoms in relation to the clinician’s total experience with ADHD subjects. Severity is rated on a 7-point scale (1=normal, not at all ill; 7=among the most extremely ill subjects). The scale was administered by a physician or PhD at the investigative site.|Baseline, 8 weeks, 24 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.||Units on a scale||Standard Deviation|Mean
711852|NCT00190775|Secondary|Change From Baseline to 12 and 24 Weeks in the Adult Attention Deficit Hyperactivity Disorder Investigator Symptom Rating Scale Total and Subscale Scores|18-item scale that captures the 18-item DSM-IV symptoms of ADHD. 9 inattentive items alternate with 9 hyperactive/impulsive items. Each item is scored 0 (none), 1 (mild), 2 (moderate), or 3 (severe). The total score range is 0-54 (0-27 for each subscale). Higher scores indicate more impaired participants. The scale was administered by a physician or PhD at the investigative site.|Baseline, 12 weeks, 24 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.||Units on a scale||Standard Deviation|Mean
711889|NCT00191113|Secondary|Glycosylated Hemoglobin, Change From Baseline|Change from core study baseline to addendum 2 maximum.|At core study baseline, and at end of 4-year addendum|Patients who were followed for at least 4 years without growth hormone treatment or who received growth hormone for at least 4 years, and who were treated as randomized and had core study baseline and addendum glucose metabolism data.||percent (%)||Standard Error|Least Squares Mean
711853|NCT00190775|Secondary|Change From Baseline to 24 Weeks in the Parenting Sense of Competence (PSOC) Scale|16-item scale to assess parenting self-esteem: the Satisfaction Subscale has 9 questions (2,3,4,5,8,9,12,14,16)=54; the Efficacy Subscale has 7 questions (1,6,7,10,11,13,15)=43. Each response on the satisfaction subscale is answered on a 6-point scale (strongly agree/strongly disagree). Higher scores indicate greater satisfaction and greater self-efficacy. Lower scores mean more impairment. Participants with a child aged 6-12 or 13-17 years living at home completed the scale.|Baseline, 24 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.||Units on a scale||Standard Deviation|Mean
711854|NCT00190775|Secondary|Change From Baseline to 8 Weeks in the Parenting Sense of Competence (PSOC) Scale|16-item scale to assess parenting self-esteem: the Satisfaction Subscale has 9 questions (2,3,4,5,8,9,12,14,16)=54; the Efficacy Subscale has 7 questions (1,6,7,10,11,13,15)=43. Each response on the satisfaction subscale is answered on a 6-point scale (strongly agree/strongly disagree). Higher scores indicate greater satisfaction and greater self-efficacy. Lower scores mean more impairment. Participants with a child aged 6-12 or 13-17 years living at home completed the scale.|Baseline, 8 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.||Units on a scale||Standard Deviation|Mean
711855|NCT00190775|Secondary|Mean Change From Baseline to 24 Weeks in the Child Disruptive Behavior Rating Scale (CDBRS) Parent Form Oppositional Defiant Disorder (ODD) and Conduct Disorder Flags|Items 19-26 of the CDBRS assess the presence of Oppositional Defiant Disorder (ODD) (yes if participant answers >=4 items as 2 [often] or 3 [very often]). Items 1-26 are rated on a 0-3 scale (0=never/rarely, 1=sometimes, 2=often, 3=very often). 15 yes/no items assess the presence of Conduct Disorder (yes if >3 items answered yes). Participants with a child 6-12 years old living in the home completed the scale.|Baseline, 24 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.||Participants|||Number
711856|NCT00190775|Secondary|Mean Change From Baseline to 24 Weeks in the Child Disruptive Behavior Rating Scale (CDBRS) Parent Form|Contains the symptoms of ADHD (9 items for Inattention/9 items for Hyperactive-Impulsive). Total maximum severity score is 54 (0-27 for each subscale). Higher scores indicate greater impairment. Participants with a child 6-12 years old living in the home completed the scale.|Baseline, 24 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.||Units on a scale||Standard Deviation|Mean
711857|NCT00190775|Secondary|Change From Baseline to 24 Weeks in the Alabama Parenting Questionnaire (APQ) Child Form|42-item scale, 3 subscales (z-scores [-2 to 2]): Dysfunctional/Negative/Positive Parenting. Each construct rated 1=never/5=always (# items): involvement (10), supervision (10), positive parenting (6), inconsistent discipline (6), other discipline (7), harsh discipline (3). Higher scores indicate impairment: dysfunctional/negative parenting composite; supervision, inconsistent discipline, harsh punishment, other discipline. Lower scores indicate impairment: positive parenting composite; positive parenting, involvement. Completed by child 6-12 or 13-17 years living at home.|Baseline, 24 Weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.||Units on a scale||Standard Deviation|Mean
711858|NCT00190775|Secondary|Change From Baseline to 12 Weeks in the Alabama Parenting Questionnaire (APQ) Child Form|42-item scale, 3 subscales (z-scores [-2 to 2]): Dysfunctional/Negative/Positive Parenting. Each construct rated 1=never/5=always (# items): involvement (10), supervision (10), positive parenting (6), inconsistent discipline (6), other discipline (7), harsh discipline (3). Higher scores indicate impairment: dysfunctional/negative parenting composite; supervision, inconsistent discipline, harsh punishment, other discipline. Lower scores indicate impairment: positive parenting composite; positive parenting, involvement. Completed by child 6-12 or 13-17 years living at home.|Baseline, 12 Weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.||Units on a scale||Standard Deviation|Mean
711859|NCT00190775|Secondary|Change From Baseline to 24 Weeks in the Alabama Parenting Questionnaire (APQ) Parent Form|42-item scale, 3 subscales (z-scores [-2 to 2]): Dysfunctional/Negative/Positive Parenting. Each construct rated 1=never/5=always (# items): involvement (10), supervision (10), positive parenting (6), inconsistent discipline (6), other discipline (7), harsh discipline (3). Higher scores indicate impairment: dysfunctional/negative parenting composite; supervision, inconsistent discipline, harsh punishment, other discipline. Lower scores indicate impairment: positive parenting composite; positive parenting, involvement. Completed by participants with a child 6-12 or 13-17 years living at home.|Baseline, 24 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.||Units on a scale||Standard Deviation|Mean
711860|NCT00190775|Secondary|Change From Baseline to 12 Weeks in the Alabama Parenting Questionnaire (APQ) Parent Form|42-item scale, 3 subscales (z-scores [-2 to 2]): Dysfunctional/Negative/Positive Parenting. Each construct rated 1=never/5=always (# items): involvement (10), supervision (10), positive parenting (6), inconsistent discipline (6), other discipline (7), harsh discipline (3). Higher scores indicate impairment: dysfunctional/negative parenting composite; supervision, inconsistent discipline, harsh punishment, other discipline. Lower scores indicate impairment: positive parenting composite; positive parenting, involvement. Completed by participants with a child 6-12 or 13-17 years living at home.|Baseline, 12 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.||Units on a scale||Standard Deviation|Mean
711890|NCT00191113|Secondary|Number of Participants With Any Abnormal Fasting Glucose/Insulin Ratio Value|Indicates if patient had any measured value below threshold of normality at any visit during addendum. Abnormal Fasting Glucose/Insulin Ratio = Fasting Glucose/Insulin Ratio <=4.5 milligrams per 10^-4 Units (mg/10^-4U).|At start and through end of 4-year addendum|Patients with any Addendum 2 glucose metabolism data. Calculated only for patients with fasting blood <100 mg/dL.||participants|||Number
711861|NCT00190775|Secondary|Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Child Domains|120-item scale includes 101 items rated on 5-point Likert scale (strongly agree/strongly disagree) or 4-5 point multiple choices. Child Domain characteristics’ subscales and score ranges include: Distractibility/Hyperactivity (9-45), Adaptability (11-55), Reinforces Parent (6-30), Demandingness (9-45), Mood (5-25), Acceptability (7-35). Total Score measures relative magnitude of stress in parent-child system. A Child Domain score >=116 (>=85th percentile) is indicative of impairment. Participants with a child aged 6-12 or 13-17 years living at home completed the scale.|Baseline, 24 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.||Units on a scale||Standard Deviation|Mean
711862|NCT00190775|Secondary|Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Parent Domains|120-item scale includes 101 items rated on 5-point Likert scale (strongly agree/strongly disagree) or 4-5 point multiple choices. Adult Domain characteristics’ subscales and score ranges include: Competence (13-65), Isolation (6-30), Attachment (7-35), Health (5-25), Role Restriction (7-35), Depression (9-45), Spouse (7-35). Total Score measures relative magnitude of stress in parent-child system. Parent Domain score >=148 (>=85th percentile) is indicative of impairment. Participants with a child aged 6-12 or 13-17 years living at home completed the scale.|Baseline, 24 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.||Units on a scale||Standard Deviation|Mean
711863|NCT00190775|Secondary|Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Total Stress and Life Stress|The PSI 19-item Stress Life Events scale has yes/no responses and measures situational circumstances beyond control (death of family member, divorce, etc.) in the past 12 months. Maximum score (all answers=yes) is 79; a Life Stress raw score >=17 indicates high stress. Each question is weighted based upon the event. Total Score measures relative magnitude of stress in parent-child system. High scores (>=85th percentile) indicate higher stress. Total Stress >=258 is indicative of impairment. Participants with a child aged 6-12 or 13-17 years living at home completed the scale.|Baseline, 24 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.||Units on a scale||Standard Deviation|Mean
711864|NCT00190775|Secondary|Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Child Domains|120-item scale includes 101 items rated on 5-point Likert scale (strongly agree/strongly disagree) or 4-5 point multiple choices. Child Domain characteristics’ subscales and score ranges include: Distractibility/Hyperactivity (9-45), Adaptability (11-55), Reinforces Parent (6-30), Demandingness (9-45), Mood (5-25), Acceptability (7-35). Total Score measures relative magnitude of stress in parent-child system. A Child Domain score >=116 (>=85th percentile) is indicative of impairment. Participants with a child aged 6-12 or 13-17 years living at home completed the scale.|Baseline, 8 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.||Units on a scale||Standard Deviation|Mean
711865|NCT00190775|Secondary|Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Parent Domains|120-item scale includes 101 items rated on 5-point Likert scale (strongly agree/strongly disagree) or 4-5 point multiple choices. Adult Domain characteristics’ subscales and score ranges include: Competence (13-65), Isolation (6-30), Attachment (7-35), Health (5-25), Role Restriction (7-35), Depression (9-45), Spouse (7-35). Total Score measures relative magnitude of stress in parent-child system. Parent Domain score >=148 (>=85th percentile) is indicative of impairment. Participants with a child aged 6-12 or 13-17 years living at home completed the scale.|Baseline, 8 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.||Units on a scale||Standard Deviation|Mean
711866|NCT00190775|Secondary|Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Total Stress and Life Stress|The PSI 19-item Stress Life Events scale has yes/no responses and measures situational circumstances beyond control (death of family member, divorce, etc.) in the past 12 months. Maximum score (all answers=yes) is 79; a Life Stress raw score >=17 indicates high stress. Each question is weighted based upon the event. Total Score measures relative magnitude of stress in parent-child system. High scores (>=85th percentile) indicate higher stress. Total Stress >=258 is indicative of impairment. Participants with a child aged 6-12 or 13-17 years living at home completed the scale.|Baseline, 8 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.||Units on a scale||Standard Deviation|Mean
711867|NCT00190775|Primary|Change From Baseline to 12 Weeks in the Conners' Adult Attention Deficit Hyperactivity Disorder Rating Scale - Investigator Rated: Screening Version (CAARS-Inv:SV) Total ADHD Symptoms Score|30-item scale containing 3 subscales: inattention (9 items), hyperactivity/ impulsivity (9 items), and ADHD Index (12 items). Each item is scored 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Total ADHD symptoms score=sum of the inattention and hyperactivity/impulsivity subscales. Total Scores range from 0-54 (range of 0-27 for the inattention and hyperactivity subscales; 0-36 for the ADHD Index) with higher scores indicating more impaired participants. The scale was administered by a physician/PhD at the investigative site.|Baseline, 12 weeks|Participants with a baseline and at least one post-baseline CAARS Total ADHD Symptoms Score were included. The protocol was amended to extend the open-label portion of the study from 8 weeks to 12 weeks, and the primary objective was modified to include the CAARS-IV:SV at 12 weeks.||Units on a scale||Standard Error|Least Squares Mean
711891|NCT00191113|Secondary|Minimum Fasting Glucose/Insulin Ratio Values|Minimum measured value over addendum. In special cases an additional measurement is taken at 2 years.|At start and through end of 4-year addendum (up to an additional 2 years)|Patients with addendum data who were followed for at least 4 years without growth hormone treatment (and never received growth hormone) or who received growth hormone for at least 4 years.||milligrams per 10^-4 Units (mg/[10^-4]U)||Standard Deviation|Mean
712280|NCT00189423|Secondary|Survival to 24 Hours|Number of patients who were alive 24 hours after the initial cardiac arrest.|24 hours following cardiac arrest|Population is a modified Intent to Treat (mITT) population who met ititial inclusion criteria and final inclusion criteria.||patients|||Number
711868|NCT00190775|Secondary|Change From Baseline to 24 Weeks in the Dyadic Adjustment Scale (DAS) - Spouse/Significant Other|32-item self-report scale to assess quality of the relationship perceived by the spouse/significant other. Response anchors vary and include a 5-, 6- or 7-point Likert scale (always agree/disagree; all the time/never); and 2 yes/no items. Assesses 4 relationship aspects (# items): dyadic satisfaction (10), cohesion (5), and consensus (13), and affectional expression (4). Raw score total=0-151 and is converted to a t-score (0-100; mean=50, SD=10). T-scores of 45-55 indicate a typical score (no concern). Scores <30 indicate significant impairment. Lower scores indicate poorer dyadic adjustment.|Baseline, 24 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.||T-scores of units on a scale||Standard Deviation|Mean
711869|NCT00190775|Secondary|Change From Baseline to 8 Weeks in the Dyadic Adjustment Scale (DAS) - Spouse/Significant Other|32-item self-report scale to assess quality of the relationship perceived by the spouse/significant other. Response anchors vary and include a 5-, 6- or 7-point Likert scale (always agree/disagree; all the time/never); and 2 yes/no items. Assesses 4 relationship aspects (# items): dyadic satisfaction (10), cohesion (5), and consensus (13), and affectional expression (4). Raw score total=0-151 and is converted to a t-score (0-100; mean=50, SD=10). T-scores of 45-55 indicate a typical score (no concern). Scores <30 indicate significant impairment. Lower scores indicate poorer dyadic adjustment.|Baseline, 8 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.||T-scores of units on a scale||Standard Deviation|Mean
711870|NCT00190775|Secondary|Change From Baseline to 24 Weeks in the Dyadic Adjustment Scale (DAS) - Participant|32-item self-report scale to assess quality of the relationship perceived by participants. Response anchors vary and include a 5-, 6- or 7-point Likert scale (always agree/disagree; all the time/never); and 2 yes/no items. Assesses 4 relationship aspects (# items): dyadic satisfaction (10), cohesion (5), and consensus (13), and affectional expression (4). Raw score total=0-151 and is converted to a t-score (0-100; mean=50, SD=10). T-scores of 45-55 indicate a typical score (no concern). Scores <30 indicate significant impairment. Lower scores indicate poorer dyadic adjustment.|Baseline, 24 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.||T-scores of units on a scale||Standard Deviation|Mean
711871|NCT00190775|Secondary|Change From Baseline to 8 Weeks in the Dyadic Adjustment Scale (DAS) - Participant|32-item self-report scale to assess quality of the relationship perceived by participants. Response anchors vary and include a 5-, 6- or 7-point Likert scale (always agree/disagree; all the time/never); and 2 yes/no items. Assesses 4 relationship aspects (# items): dyadic satisfaction (10), cohesion (5), consensus (13), affectional expression (4). Raw score total=0-151 and is converted to a t-score (0-100; mean=50, standard deviation (SD)=10). T-scores of 45-55 indicate a typical score (no concern). Scores <30 indicate significant impairment. Lower scores indicate poorer dyadic adjustment.|Baseline, 8 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.||T-scores of units on a scale||Standard Deviation|Mean
711872|NCT00190775|Secondary|Change From Baseline to 24 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other|FAM consists of 3 components: General Scale; Dyadic Relationships Scale (DRS), and Self-Rating Scale. The spouse/significant other completed the DRS scale, a 42-item self-report scale providing quantitative indices of family strengths/weaknesses. Items are rated 0-3 (strongly agree, agree, disagree, strongly disagree). Raw scores=0-18 (each subscale) and are converted to a t-score (mean=50, standard deviation (SD)=10; scores range from 0-100). T-scores should be between 40-60. T-scores >=60 indicate disturbance in family functioning.|Baseline, 24 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.||T-scores of units on a scale||Standard Deviation|Mean
711873|NCT00190775|Secondary|Change From Baseline to 8 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other|FAM consists of 3 components: General Scale; Dyadic Relationships Scale (DRS), and Self-Rating Scale. The spouse/significant other completed the DRS scale, a 42-item self-report scale providing quantitative indices of family strengths/weaknesses. Items are rated 0-3 (strongly agree, agree, disagree, strongly disagree). Raw scores=0-18 (each subscale) and are converted to a t-score (mean=50, standard deviation (SD)=10; scores range from 0-100). T-scores should be between 40-60. T-scores >=60 indicate disturbance in family functioning.|Baseline, 8 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.||T-scores of units on a scale||Standard Deviation|Mean
711874|NCT00190775|Secondary|Change From Baseline to 24 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Participant|FAM consists of 3 components: General Scale; Dyadic Relationships Scale (DRS), and Self-Rating Scale. Participants completed the DRS scale, a 42-item self-report scale providing quantitative indices of family strengths/weaknesses. Items are rated 0-3 (strongly agree, agree, disagree, strongly disagree). Raw scores=0-18 (each subscale) and are converted to a t-score (mean=50, standard deviation (SD)=10; scores range from 0-100). T-scores should be between 40-60. T-scores >=60 indicate disturbance in family functioning.|Baseline, 24 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.||T-scores of units on a scale||Standard Deviation|Mean
711886|NCT00191100|Primary|Number of Participants With Progressive Disease or Death Due to Any Cause at 3 Years|"Original outcome was Progression-Free Survival (PFS) probability at 3 years. PFS=time from baseline to progressive disease (PD) or death from any cause. Probability is not an accepted Measure Type, so number of progression-free patients still at risk and cumulative number of patients that had an event (PD or death of any cause) are presented."|Tumor assessments at baseline, weekly during chemoradiation & brachytherapy, on Day 1 of adjuvant Cycles 1&2 for Arm A, at the 30-day post-study visit, every 4/6 months for 12/48 months of the short/long post-study follow-up periods respectively|Intention-to-treat population includes all randomized participants. Participants were analyzed according to treatment they were randomly assigned.||participants|||Number
711875|NCT00190775|Secondary|Change From Baseline to 8 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Participant|FAM consists of 3 components: General Scale; Dyadic Relationships Scale (DRS), and Self-Rating Scale. Participants completed the DRS scale, a 42-item self-report scale providing quantitative indices of family strengths/weaknesses. Items are rated 0-3 (strongly agree, agree, disagree, strongly disagree). Raw scores=0-18 (each subscale) and are converted to a t-score (mean=50, standard deviation (SD)=10; scores range from 0-100). T-scores should be between 40-60. T-scores >=60 indicate disturbance in family functioning.|Baseline, 8 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.||T-scores of units on a scale||Standard Deviation|Mean
711876|NCT00190775|Primary|Change From Baseline to 24 Weeks in the Conners' Adult Attention Deficit Hyperactivity Disorder Rating Scale - Investigator Rated: Screening Version (CAARS-Inv:SV) Total ADHD Symptoms Score|30-item scale containing 3 subscales: inattention (9 items), hyperactivity/ impulsivity (9 items), and ADHD Index (12 items). Each item is scored 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Total ADHD symptoms score=sum of the inattention and hyperactivity/impulsivity subscales. Total Scores range from 0-54 (range of 0-27 for the inattention and hyperactivity subscales; 0-36 for the ADHD Index) with higher scores indicating more impaired participants. The scale was administered by a physician/PhD at the investigative site.|Baseline, 24 weeks|Participants with a baseline and at least one post-baseline CAARS Total ADHD Symptoms Score were included.||Units on a scale||Standard Error|Least Squares Mean
711877|NCT00190983|Secondary|Overall Survival|Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.|baseline until death from any cause (up to 5 years)|||months||Full Range|Median
711878|NCT00190983|Secondary|Progression-Free Survival|The period from study entry until disease progression, death or date of last contact.|baseline until documented tumor progression (up to 5 years)|All enrolled participants who experienced disease progression.||months||Full Range|Median
711879|NCT00190983|Secondary|Duration of Response|The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.|time of initial response until documented tumor progression (up to 5 years)|All enrolled participants who had either a complete response (n=0) or partial response (n=4).||months||Full Range|Median
711880|NCT00190983|Primary|Tumor Response|"Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve (respond), stay the same (stable), or worsen (progression) during treatment."|baseline to measured progressive disease (up to 5 years)|||participants|||Number
711881|NCT00191100|Secondary|Number of Participants With Progressive Disease or Death Due to Any Cause at Various Time Points|Original outome was Progression-Free Survival, which was defined as time from baseline to progressive disease or death due to any cause.|Tumor assessments at baseline, weekly during chemoradiation & brachytherapy, on Day 1 of adjuvant Cycles 1&2 for Arm A, at the 30-day post-study visit, every 4/6 months for 12/48 months of the short/long post-study follow-up periods respectively|Intent-to-treat population includes all randomized patients. Patients were analyzed according to treatment they were randomly assigned.||participants|||Number
711882|NCT00191100|Secondary|Number of Participants Who Died From Any Cause at Various Time Points|Original outcome was Overall Survival, which was defined as time from baseline to death from any cause.|baseline to date of death from any cause (includes 60 month follow-up period)|Intent-to-treat population includes all randomized patients. Patients were analyzed according to treatment they were randomly assigned.||participants|||Number
711883|NCT00191100|Secondary|Tumor Response|Tumor response rate (TRR) defined as number of qualified responder patients with confirmed complete or partial response.|Tumor assessments at baseline, weekly during chemoradiation & brachytherapy, on Day 1 of adjuvant Cycles 1&2 for Arm A, at the 30-day post-study visit, every 4/6 months for 12/48 months of the short/long post-study follow-up periods respectively|Qualified Responders population included all randomized patients with: Histological diagnosis of cancer of cervix; No previous chemotherapy or radiation therapy; Presence of bidimensionally measurable disease, at least 2 cm in diameter; Treatment with at least one dose of study chemotherapy. Patients were analyzed according to treatment assigned.||participants|||Number
711884|NCT00191100|Secondary|Local Failure Rate|Local failure rate (LFR) was defined as the the proportion of per-protocol participants who had progressive disease (PD) in the cervix or pelvis. LFR = The number of (a) participants who progressed in the cervix or pelvis divided by (b) the number of participants in each arm. (LFR=a/b).|Tumor assessments at baseline, weekly during chemoradiation & brachytherapy, on Day 1 of adjuvant Cycles 1&2 for Arm A, at the 30-day post-study visit, every 4/6 months for 12/48 months of the short/long post-study follow-up periods respectively|Per protocol population included all randomized patients with: Histological diagnosis of cancer of cervix; No previous chemotherapy or radiation therapy; Presence of bidimensionally measurable disease, at least 2 cm in diameter; Treatment with at least one dose of study chemotherapy. Patients were analyzed according to treatment actually received.||proportion of participants with PD|||Number
711885|NCT00191100|Secondary|Number of Participants With Progressive Disease or Death Due to Disease Under Study at Various Time Points|Original outcome was Time to Progressive Disease (TTPD), which is the time from baseline to event (progressive disease or death due to study disease). The median TTPD was not achieved and therefore the cumulative number of participants with event (and those still at risk) at various time points are presented.|Tumor assessments at baseline, weekly during chemoradiation & brachytherapy, on Day 1 of adjuvant Cycles 1&2 for Arm A, at the 30-day post-study visit, every 4/6 months for 12/48 months of the short/long post-study follow-up periods respectively|Intent-to-treat population includes all randomized patients. Patients were analyzed according to treatment they were randomly assigned.||participants|||Number
711887|NCT00191113|Secondary|Number of Participants With Any Abnormal Glycosylated Hemoglobin (HbA1c) Value|Indicates if patient had any measured value exceeding threshold of normality at any visit during addendum. Abnormal Glycosylated Hemoglobin = HbA1c ≥6.8% (up until 11-May-1998); and then HbA1c ≥6.1% (from 19-May-1998 onwards).|At start and through end of 4-year addendum|Patients with any Addendum 2 glucose metabolism data.||participants|||Number
711892|NCT00191113|Secondary|Number of Participants With Any Abnormal Fasting Insulin Value|Indicates if patient had any measured value exceeding threshold of normality at any visit during addendum. Abnormal Fasting Insulin = Fasting Insulin >=35 micro International Units per milliliter (uIU/mL).|At start and through end of 4-year addendum|Patients with any Addendum 2 glucose metabolism data||participants|||Number
711893|NCT00191113|Secondary|Maximum Fasting Insulin Values|Maximum measured value over addendum. In special cases an additional measurement is taken at 2 years.|At start and through end of 4-year addendum (up to an additional 2 years)|Patients with addendum data who were followed for at least 4 years without growth hormone treatment (and never received growth hormone) or who received growth hormone for at least 4 years.||micro International Units per milliliter||Standard Deviation|Mean
711894|NCT00191113|Secondary|Number of Participants With Any Abnormal Fasting Glucose Value|Indicates if patient had any measured value exceeding threshold of normality at any visit during addendum. Abnormal Fasting Glucose=Fasting Glucose >=100 milligrams per deciliter (mg/dL).|At start and through end of 4-year addendum|Patients with any Addendum 2 glucose metabolism data||participants|||Number
711895|NCT00191113|Secondary|Maximum Fasting Glucose Value|Maximum measured value over addendum. In special cases an additional measurement is taken at 2 years.|At start and through end of 4-year addendum (up to an additional 2 years)|Patients with addendum data who were followed for at least 4 years without growth hormone treatment (and never received growth hormone) or who received growth hormone for at least 4 years.||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
711896|NCT00191113|Secondary|Fasting Glucose, Change From Baseline|Change from core study baseline to addendum 2 maximum.|At core study baseline, and at end of 4-year addendum|Patients who were followed for at least 4 years without growth hormone treatment or who received growth hormone for at least 4 years, and who were treated as randomized and had core study baseline and addendum glucose metabolism data.||mg / dL||Standard Error|Least Squares Mean
711897|NCT00191113|Secondary|Number of Participants With Hearing Loss, Audiologist Assessment|Sensorineural Hearing Loss (SNHL)=air conduction threshold >20 dB HL and air-bone gap ≤10 dB HL; Conductive Hearing Loss (CHL)= air conduction threshold >20 dB HL, bone conduction threshold ≤20 dB HL and air-bone gap >10 dB HL; Mixed Hearing Loss (MHL) = evidence of SNHL as defined above and CHL as defined above, in the same ear; Unspecified Hearing Loss (UHL)= abnormal hearing with none of SNHL, CHL, or MHL present.|at completion of core study or beginning of addendum|All Randomized Patients with Hearing Examination for whom Audiologist responded to Hearing Loss question||participants|||Number
711898|NCT00191113|Secondary|Number of Participants With Abnormal Impedance Tympanometry, Audiologist Assessment||at completion of core study or beginning of addendum|All Randomized Patients with Hearing Examination||participants|||Number
711899|NCT00191113|Secondary|Number of Participants With Abnormal Speech Audiometry, Audiologist Assessment||at completion of core study or beginning of addendum|All Randomized Patients with Hearing Examination||participants|||Number
711900|NCT00191113|Secondary|Number of Participants With an Abnormal Pure Tone Audiometry, Audiologist Assessment||at completion of core study or beginning of addendum|All Randomized Patients with Hearing Examination||participants|||Number
711901|NCT00191113|Secondary|Height (Centimeters [cm])|Most mature measurement available, at or after attainment of Final Height.|every 3 months during core study, and at start and end of 4-year addendum|||centimeters (cm)||Standard Error|Least Squares Mean
711902|NCT00191113|Secondary|Height Standard Deviation Score (SDS) (National Center for Health Statistics [NCHS]), Change From Baseline, As-Treated Population|Value analyzed is change from baseline to the most mature height measurement available. The terms Standard Deviation Score (SDS) and National Center for Health Statistics (NCHS) were defined in baseline characteristics. Greater height SDS values indicate greater height; positive values of change from baseline indicate increased height.|every 3 months during core study, and at start and end of 4-year addendum|||Standard Deviation Score (SDS) [NCHS]||Standard Error|Least Squares Mean
711903|NCT00191113|Primary|Height Standard Deviation Score (SDS) (National Center for Health Statistics [NCHS]), Last Measurement After Attainment of Final Height|SDS report the number of standard deviations from the mean for age and sex for an individual measurement (normal range: -2 to +2 SDS). Height SDS [NCHS] uses the NCHS US general female population reference height values for age (Kuczmarski RJ et al. 2000) as the population mean and standard deviation. Calculation of Height SDS is provided in Height SDS [Lyon] description (Baseline). Since data reported by Kuczmarski RJ et al provides US general female population standards, values of Height SDS [NCHS] for untreated patients with Turner syndrome tend to be below zero e.g, -2.0 to -4.0 SDS.|at completion of core study, or at end of 4-year addendum|Population of patients for whom Final Height measurements are available. Efficacy analysis with as-treated treatment groups, at most mature measurement available at or after attainment of Final Height.||Standard Deviation Score (SDS) [NCHS]||Standard Error|Least Squares Mean
711904|NCT00191113|Primary|Height Standard Deviation Score (SDS) (National Center for Health Statistics [NCHS]), Change From Baseline to Last Measurement, As Randomized Population|Value analyzed is change from baseline to the most mature height measurement available. The terms Standard Deviation Score (SDS) and National Center for Health Statistics (NCHS) were defined in baseline characteristics. Greater height SDS values indicate greater height; positive values of change from baseline indicate increased height.|Baseline, and end of 4-year addendum|Population of all randomized patients. Intent to treat analysis with as-randomized treatment groups, at most mature measurement available.||Standard Deviation Score (SDS) [NCHS]||Standard Error|Least Squares Mean
711905|NCT00191139|Secondary|Lung Cancer Symptom Scale (LCSS) Assessment Post-randomization|LCSS measures physical & functional dimensions. The patient scale contains 9 items, 3 summation & 6 symptom items. Each item is marked on a visual analog scale (0=low; 100=high). The mean of the 6 symptoms is used to calculate the average symptom burden index (ASBI). Improved=mean ASBI assessments from any 2 consecutive improved post-randomization assessments was at least 0.5 standard deviation (SD) below pre-randomization ASBI; worse=mean ASBI from any 2 consecutive post-randomization assessments was at least 0.5 SD above pre-randomization ASBI; stable=criteria for improved/worse not met.|baseline to 3 months after last dose of study treatment (three 21-day cycles)|as-treated population||participants|||Number
711906|NCT00191139|Secondary|Overall Survival|Overall survival is the duration from enrollment to death from any cause. For patients who are alive, overall survival is censored at the last contact.|baseline to date of death from any cause up to 2057 days|ITT population||days||95% Confidence Interval|Median
711907|NCT00191139|Secondary|Progression-Free Survival|Defined as the time from randomization into consolidation treatment to the first date of documented disease progression or death. Progression-free survival time was censored at the date of the last follow-up visit at which disease was assessed for patients who were still alive and who had not progressed.|baseline to measured progressive disease up to 2057 days|ITT population||days||95% Confidence Interval|Median
711908|NCT00191139|Secondary|Number of Patients With Overall Tumor Response|Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)=disappearance of all target lesions; Partial Response (PR) =30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD) =20% increase in sum of longest diameter of target lesions; Stable Disease (SD)=small changes that do not meet above criteria. The total number of CRs plus PRs equals overall response rate (ORR).|randomization and every 3 months up to 2 years of post-study followup|ITT population||participants|||Number
711909|NCT00191139|Primary|2-Year Survival|Percentage of participants alive at 2 years.|2 years|Intention to treat (ITT) population||percentage of participants|||Number
711910|NCT00191152|Secondary|Summary of Changes in Rotterdam Symptom Checklist by Treatment (Crossover Treatment)|RSCL includes 4 scales to assess quality of life (QOL) endpoints: 1) a 23-item physical distress level with scale score ranges from 23 to 92 [low score represents better QOL] 2)a 7-item psychological distress level with scale score ranges from 7 to 28[low score represents better QOL] 3)8-item activity level with scale score ranges from 8 to 32 [high score represents better QOL]; 1-item overall valuation of life with score range from 1 to 7 [low score represents better QOL].|First day of crossover treatment until end of crossover treatment at trial discontinuation (up to 82 months)|Participants with RSCL at baseline (conclusion of initial treatment)and end of crossover treatment||units on a scale||Standard Deviation|Mean
711911|NCT00191152|Secondary|Summary of Changes in Rotterdam Symptom Checklist (RSCL) by Treatment (Initial Treatment)|RSCL includes 4 scales to assess quality of life (QOL) endpoints: 1) a 23-item physical distress level with scale score ranges from 23 to 92 [low score represents better QOL] 2)a 7-item psychological distress level with scale score ranges from 7 to 28[low score represents better QOL] 3)8-item activity level with scale score ranges from 8 to 32 [high score represents better QOL]; 1-item overall valuation of life with score range from 1 to 7 [low score represents better QOL].|Baseline until crossover treatment began (up to 82 months)|Participants with RSCL at baseline and end of initial treatment.||units on a scale||Standard Deviation|Mean
711912|NCT00191152|Secondary|Summary of Changes in Karnofsky Performance Status (KPS) by Treatment (Crossover Treatment)|KPS ranges from 0 to 100, subdivided into three categories: incapacitated (0-40), self-care (50-70), and normal activity (80-100).|First day of crossover treatment until end of crossover treatment at trial discontinuation (up to 82 moths)|Participants with KPS at baseline (conclusion of initial treatment) and end of crossover treatment||units on a scale||Standard Deviation|Mean
711913|NCT00191152|Secondary|Summary of Changes in Karnofsky Performance Status (KPS) by Treatment (Initial Treatment)|KPS ranges from 0 to 100, subdivided into three categories: incapacitated (0-40), self-care (50-70), and normal activity (80-100).|Baseline until crossover treatment began (up to 82 months)|Intent-to-treat population, initial treatment, participants with KPS at baseline and end of initial treatment.||units on a scale||Standard Deviation|Mean
711914|NCT00191152|Secondary|Best Overall Response (Crossover Treatment)|Best overall response was the best response recorded from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Response assessed using RECIST criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that did not meet above criteria.|Best response from start of treatment until disease progression/recurrence (up to 82 months)|Only included participants who crossed over from initial treatment to crossover treatment.||participants|||Number
711915|NCT00191152|Secondary|Best Overall Response (Initial Treatment)|Best overall response was the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Response was assessed using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that did not meet above criteria.|Best response from start of treatment until disease progression/recurrence (up to 82 months)|ITT population.||participants|||Number
711916|NCT00191152|Secondary|Overall Survival|Overall survival time was defined as the number of months between the date of randomization and the date of death due to any cause. The overall survival time was censored at the date of last contact for participants who were still alive.|Date of randomization to date of death from any cause (up to 82 months)|Intent to treat population: all randomized participant. Censored participants: 75 in gemcitabine/docetaxel arm; 72 in docetaxel/capecitabine arm.||months||95% Confidence Interval|Median
711917|NCT00191152|Secondary|Duration of Response (Crossover Treatment)|At crossover treatment, duration of response was measured from the time criteria were met for complete response (CR) or partial response (PR), until first date that recurrent or progressive disease was objectively documented or date of death due to any cause, whichever came first. This definition only applied to those who crossed over & achieved CR or PR in crossover treatment. Duration of response censored at earliest of: 1) date of last contact for those alive without disease progression; or 2) start date of other anti-tumor therapy for documented disease progression.|Date of CR or PR until first date of recurrent or progressive disease after receiving crossover treatment was objectively documented or date of date due to any cause, whichever came first (up to 82 months)|ITT population: participants with CR or PR as best overall response at crossover treatment. Censored participants: 4 in capecitabine arm; 2 in gemcitabine arm.||months||95% Confidence Interval|Median
711941|NCT00191282|Secondary|Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 9|Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).|Visit 6 (Month 9)|All randomized participants with self-reported hypoglycemia during Month 9.||episodes of hypoglycemia|||Number
711918|NCT00191152|Secondary|Duration of Response (Initial Treatment)|Among tumor responders, duration of tumor response was measured from the date of response (complete response [CR] or partial response [PR] until the first date of documented progression or death from any cause. Duration of response was censored at the earliest of: 1) date of last contact for participants alive without disease progression (DP); or 2) start date of other anti-tumor therapy for DP; or 3) dose date of crossover treatment.|Date of response (CR or PR) until the first date of documented progression or death from any cause (up to 82 months)|ITT population: participants with CR or PR as best overall response (initial treatment). Censored participants: 16 in gemcitabine/docetaxel arm; 30 in docetaxel/capecitabine arm.||months||95% Confidence Interval|Median
711919|NCT00191152|Primary|Time to Disease Progression (Initial Treatment)|Time to disease progression (TTDP) at initial treatment was defined as the number of months between date of randomization and the date of first documented disease progression or the date of death due to disease under study, whichever came first. TTDP censored at earliest of: 1) date of death not due to disease; or 2) date of last contact for participants alive without disease progression; or 3) start date of other anti-tumor therapy; or 4) first dose date of crossover treatment.|Randomization date to the earliest date of first documented disease progression date or the date of death if the participant died due to study disease (up to 82 months)|Intent-to-treat (ITT) population: all randomized participants. Censored participants in initial treatment: 68 gemcitabine/docetaxel arm; 83 docetaxel/capecitabine arm.||months||95% Confidence Interval|Median
711920|NCT00191152|Secondary|Progression-Free Survival (Crossover Treatment)|For crossover treatment, progression-free survival (PFS) was defined as the number of months between first dose date of crossover treatment and date of documented disease progression or date of death due to any cause, whichever came first. PFS for crossover treatment only applied to those participants who crossed over from initial treatment to crossover treatment. PFS was censored at the earliest of: 1) date of last contact for participants alive without disease progression; or 2) start date of other anti-tumor therapy for participants with documented disease progression.|First dose date of crossover treatment to date of first-documented progression after receiving crossover treatment or date of death due to any cause, whichever came first (up to 82 months)|ITT population: all randomized participants. Censored participants, crossover treatment: 13 in capecitabine arm; 10 in gemcitabine arm.||months||95% Confidence Interval|Median
711921|NCT00191152|Secondary|Progression-Free Survival (Initial Treatment)|For initial treatment, progression-free survival (PFS) was defined as the number of months between the date of randomization and the date of first documented disease progression or the date of death due to any cause, whichever came first. Time to PFS was censored at the earliest of: 1) date of last contact for participants alive without disease progression; or 2) start date of other anti-tumor therapy for progression; or 3) first dose date of crossover treatment.|Date of randomization until the date of first documented progression or date of death from any cause, whichever came first (up to 82 months)|ITT: all randomized participants. Censored participants (initial treatment): 64 in gemcitabine/docetaxel arm; 80 in docetaxel/capecitabine arm.||months||95% Confidence Interval|Median
711922|NCT00191152|Secondary|Time to Disease Progression (Crossover Treatment)|For crossover treatment, time to disease progression (TTDP) was defined as the number of months between the first dose date of crossover treatment and the date of disease progression or the date of death due to disease under study, whichever came first. TTDP for crossover treatment only applied to those participants who crossed over from initial treatment to crossover treatment. TTDP censored at earliest of: 1)date of death not due to disease; or 2)date of last contact for participants alive without disease progression; or 3)start date of other anti-tumor therapy due to progression.|Date of first dose of crossover treatment to date of first-documented disease progression after receiving first crossover treatment or date of death due to study disease, whichever came first (up to 82 months)|ITT population: all randomized participants. Censored participants in crossover treatment: 13 in capecitabine arm; 10 in gemcitabine arm.||months||95% Confidence Interval|Median
711923|NCT00191165|Secondary|Height Velocity Standard Deviation Score (SDS) at 24 Month Endpoint|Height velocity (difference between 2 height measurements, divided by years elapsed between measurements) SDS was derived by subtracting age and gender-matched population mean height velocity from patient’s height velocity (based on measurements 12 months apart) then dividing this value by age and gender-matched population height velocity SD.|24 Months|All enrolled participants with at least one post-baseline height velocity measurement, using the last observation available prior to the 24-month visit if the 24-month height velocity was not available.||standard deviation score||Standard Deviation|Mean
711924|NCT00191165|Secondary|Change From Baseline to 12-Month and 24-Month Endpoints in Height Standard Deviation Score (SDS)|This was derived by subtracting the age-and-gender-matched population 50th percentile height from the patient’s height and then dividing this value by the age-and-gender-matched population height SD.|Baseline, 12-Months, 24-Months|All enrolled participants with at least one post-baseline height measurement, using last observation available prior to 12-month and 24-month visits respectively, if 12-month or 24-month height was not available.||standard deviation score||Standard Error|Least Squares Mean
711925|NCT00191165|Primary|Height Velocity Standard Deviation Score (SDS) at 12-Month Endpoint|Height velocity (difference between 2 height measurements, divided by years elapsed between measurements) SDS was derived by subtracting age and gender-matched population mean height velocity from patient’s height velocity (based on measurements 12 months apart) then dividing this value by age and gender-matched population height velocity SD.|12-Months|All enrolled participants with baseline and 12-month height measurements.||standard deviation score||Standard Deviation|Mean
711926|NCT00191191|Secondary|Change From Baseline to 3 Months in Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) Lung Cancer Subscale (LCS)|FACT-L LCS measured health-related quality of life (HR-QL) related to additional concerns of lung cancer. Original LCS subscale scores range from 0 to 28, but the scores were converted to scores with a range of 0 to 100 in this study. Higher scores represent better HR-QL.|Baseline (pre-dose), 3 Months after first dose of Cycle 1|Full analysis set: all randomized participants who met all of the inclusion criteria and none of the exclusion criteria and received at least one dose of study drug.||units on a scale||Standard Deviation|Mean
711959|NCT00191282|Secondary|Number of Participants Who Experienced Death From Any Cause||Randomization (Day 0) until death from any cause (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)|All randomized patients who took at least one dose of study drug.||participants|||Number
711927|NCT00191191|Secondary|Change From Baseline to 3 Months in Quality of Life Questionnaire for Cancer Patients Treated With Anticancer Drugs (QOL-ACD)|20-items assessed quality of life in patients undergoing chemotherapy. Scores range from 1 (not at all/very poor) to 5 (very much/very well). Face scale scores (patient circles number of the face that best fits his/her feelings) range from 1 (sad face) to 5 (smiling face). Item scores were grouped according to Functional (daily activity: 5 items), Physical (5 items), Emotional (psychological condition: 4 items), Social Attitude (5 items), and Face Scale (1 item). Score of subscales were converted to scores with range from 0 to 100. Higher scores represent higher QOL.|Baseline (pre-dose), 3 Months after first dose of Cycle 1|Full analysis set: all randomized participants who met all of the inclusion criteria and none of the exclusion criteria and received at least one dose of study drug.||units on a scale||Standard Deviation|Mean
711928|NCT00191191|Secondary|Progression-Free Survival (PFS)|PFS was defined as time from the scheduled date of the first treatment cycle until the date of confirmation of progressive disease on the overall response rating. For patients who died before confirmation of progressive disease, the number of days until the date of death (from any cause) was handled as progression-free survival.|baseline to measured progressive disease (up to 3.2 years)|Full analysis set: all randomized participants who met all of the inclusion criteria and none of the exclusion criteria and received at least one dose of study drug.||months||95% Confidence Interval|Median
711929|NCT00191191|Secondary|Duration of Response|The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression.|time of response to progressive disease (up to 3.2 years)|Full analysis set: all randomized participants who met all of the inclusion criteria and none of the exclusion criteria and received at least one dose of study drug.||months||95% Confidence Interval|Median
711930|NCT00191191|Primary|Best Overall Response|Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria as determined by the Case Judgment Committee. Best overall response was defined as the most favorable overall response recorded for each patient during the observation period. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.|baseline to measured progressive disease (up to 3.2 years)|Full analysis set: all randomized participants who met all of the inclusion criteria and none of the exclusion criteria and received at least one dose of study drug.||participants|||Number
711931|NCT00191269|Secondary|Pharmacokinetics - Normalized Area Under the Curve|Area under the gemcitabine plasma concentration-time curve from time zero to infinity. Gemcitabine dose was normalized to 1250 milligrams per square meter.|cycle 1|Pharmacokinetic data were available on 12 participants.||nanograms times hour per milliliter||Full Range|Geometric Mean
711932|NCT00191269|Secondary|Pharmacokinetics - Normalized Cmax|maximum gemcitabine plasma concentration normalized to 1250 milligrams per square meter of gemcitabine.|cycle 1|Pharmacokinetic data were available from 12 patients.||nanograms per milliliter (ng/mL)||Full Range|Geometric Mean
711933|NCT00191269|Secondary|Survival at 1 Year|Results are reported as number of participants alive at one year.|baseline to date of death from any cause, evaluate at 1 year|||participants|||Number
711934|NCT00191269|Secondary|Time to Progressive Disease|Time from study enrollment to first date of disease progression. Time to disease progression was censored at date of death if death was due to other cause. The minimum and maximum of this parameter were summarized, and the median time to progression and its 95% confidence interval were calculated using the Kaplan-Meier estimation.|baseline to measured progressive disease|||days||95% Confidence Interval|Median
711935|NCT00191269|Secondary|Duration of Response|For responders, the minimum and maximum of the duration of complete response, duration of partial response, and duration of overall response were summarized, and the median of response duration and its 95% confidence interval were calculated using the Kaplan-Meier estimation.|time of response to progressive disease|The 5 responding participants (complete response and partial response) at Dose Level 2.||months||95% Confidence Interval|Median
711936|NCT00191269|Primary|Tumor Response|"Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve (respond), stay the same (stable), or worsen (progression) during treatment."|baseline to measured progressive disease|||participants|||Number
711937|NCT00191282|Secondary|Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 18|Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).|Visit 8 (Month 18)|All randomized participants with self-reported hypoglycemia during Month 18.||episodes of hypoglycemia|||Number
711938|NCT00191282|Secondary|Number of Participants With Self-Reported Hypoglycemia During Month 18|Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).|Visit 8 (Month 18)|All randomized patients who took at least one dose of study drug and who were still in the study.||participants|||Number
711939|NCT00191282|Secondary|Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 12|Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).|Visit 7 (Month 12)|All randomized participants with self-reported hypoglycemia during Month 12.||episodes of hypoglycemia|||Number
711940|NCT00191282|Secondary|Number of Participants With Self-Reported Hypoglycemia During Month 12|Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).|Visit 7 (Month 12)|All randomized patients who took at least one dose of study drug and who were still in the study.||participants|||Number
711942|NCT00191282|Secondary|Number of Participants With Self-Reported Hypoglycemia During Month 9|Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).|Visit 6 (Month 9)|All randomized patients who took at least one dose of study drug and who were still in the study.||participants|||Number
711943|NCT00191282|Secondary|Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 6|Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).|Visit 5 (Month 6)|All randomized participants with self-reported hypoglycemia during Month 6.||episodes of hypoglycemia|||Number
711944|NCT00191282|Other Pre-specified|Summary of Reasons for Deaths||Randomization (Day 0) to death (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)|All randomized patients who took at least one dose of study drug.||participants|||Number
711945|NCT00191282|Secondary|Number of Participants With Self-Reported Hypoglycemia During Month 6|Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).|Visit 5 (Month 6)|All randomized patients who took at least one dose of study drug and who were still in the study.||participants|||Number
711946|NCT00191282|Secondary|Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 3|Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).|Visit 4 (Month 3)|All randomized participants who self-reported hypoglycemia during Month 3.||episodes of hypoglycemia|||Number
711947|NCT00191282|Secondary|Number of Participants With Self-Reported Hypoglycemia During Month 3|Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).|Visit 4 (Month 3)|All randomized patients who took at least one dose of study drug and who were still in the study.||participants|||Number
711948|NCT00191282|Secondary|Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 1|Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).|Visit 3 (Month 1)|All randomized participants who self-reported hypoglycemia during Month 1.||episodes of hypoglycemia|||Number
711949|NCT00191282|Secondary|Number of Participants With Self-Reported Hypoglycemia During Month 1|Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).|Visit 3 (Month 1)|All randomized patients who took at least one dose of study drug.||participants|||Number
711950|NCT00191282|Secondary|Number of Participants Who Experienced Coronary Angiography Planned After Randomization||Randomization (Day 0) until coronary angiography (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)|All randomized patients who took at least one dose of study drug.||participants|||Number
711951|NCT00191282|Secondary|Number of Participants Who Experienced Revascularization Procedure for Peripheral Vascular Disease Planned After Randomization||Randomization (Day 0) until revascularization procedure (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)|All randomized patients who took at least one dose of study drug.||participants|||Number
711952|NCT00191282|Secondary|Number of Participants Who Experienced Congestive Heart Failure|Occurrence of congestive heart failure (newly diagnosed after Visit 2).|Randomization (Day 0) until congestive heart failure (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)|All randomized patients who took at least one dose of study drug.||participants|||Number
711953|NCT00191282|Secondary|Number of Participants Who Experienced Amputation for Peripheral Vascular Disease Planned After Randomization||Randomization (Day 0) until amputation (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)|All randomized patients who took at least one dose of study drug.||participants|||Number
711954|NCT00191282|Secondary|Number of Participants Who Experienced Coronary Revascularization Procedures|Occurrence of all coronary revascularization procedures (angioplasty or coronary artery by-pass surgery) planned after randomization.|Randomization (Day 0) until coronary revascularization procedures (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)|All randomized patients who took at least one dose of study drug.||participants|||Number
711955|NCT00191282|Secondary|Number of Participants Who Experienced Hospitalization for Acute Coronary Syndromes (HACS)||Randomization (Day 0) until HACS (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)|All randomized patients who took at least one dose of study drug.||participants|||Number
711956|NCT00191282|Secondary|Number of Participants Who Experienced Stroke|Occurrence of stroke (fatal, nonfatal, any).|Randomization (Day 0) until stroke (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)|All randomized patients who took at least one dose of study drug.||participants|||Number
711957|NCT00191282|Secondary|Number of Participants Who Experienced Myocardial Infarction (MI)|Occurrence of myocardial infarction (MI) (fatal, nonfatal, any).|Randomization (Day 0) until myocardial infarction (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)|All randomized patients who took at least one dose of study drug.||participants|||Number
711958|NCT00191282|Secondary|Number of Participants Who Experienced Cardiovascular (CV) Death||Randomization (Day 0) until cardiovascular death (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)|All randomized patients who took at least one dose of study drug.||participants|||Number
711960|NCT00191282|Secondary|Number of Participants Who Experienced Primary Outcomes Adjusted for Metabolic Control and Major Cardiovascular (CV) Risk Factors|Primary outcomes adjusted for major cardiovascular (CV) risk factors (blood pressure, cholesterol [total, high density lipoprotein (HDL), and low density lipoprotein (LDL)], triglycerides, smoking, albuminuria, age, gender, and body mass index (BMI).|Randomization (Day 0) until occurrence of primary outcome (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)|All randomized patients who took at least one dose of study drug.||participants|||Number
711961|NCT00191282|Secondary|Number of Participants Who Experienced Any One of the Primary Outcomes Adjusted for Indicators of Metabolic Control|Indicators of metabolic control included glycosylated hemoglobin (HbA1c) and fasting blood glucose concentrations.|Randomization (Day 0) until occurrence of primary outcome (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)|All randomized patients who took at least one dose of study drug.||participants|||Number
711962|NCT00191282|Secondary|Number of Participants Who Experienced Death From Any Cause or Any One of the Primary Outcomes|Primary outcomes in this study consisted of: cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, hospitalization for acute coronary syndromes (HACS), and coronary revascularization procedure planned after randomization.|Randomization (Day 0) until death from any cause or one of the primary outcomes (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)|All randomized patients who took at least one dose of study drug.||participants|||Number
711963|NCT00191282|Primary|Number of Participants Who Experienced a Primary Combined Outcome|The combined study outcomes consisted of cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, hospitalization for acute coronary syndromes (HACS), and coronary revascularization procedures planned after randomization.|Randomization (Day 0) until first occurrence of primary combined outcome (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)|All randomized patients who took at least one dose of study drug||participants|||Number
711964|NCT00191308|Secondary|Overall Survival (OS)|OS was defined as the time from treatment start to death from any cause. For participants who were alive, OS was censored at the last contact date.|Treatment start to death from any cause (up to 47.6 months)|OS was evaluated on all qualified enrolled patients who received at least 1 dose of study medication.||months||95% Confidence Interval|Median
711965|NCT00191308|Secondary|Disease Free Survival (DFS)|DFS was the time from date of first dose to first observation of progressive disease (PD) or death due to any cause. PD=20% increase in sum of longest diameter of target lesions. If a participant was not known to have died or have PD, DFS was censored at the date of the last objective progression-free disease assessment.|Treatment start to disease progression or death from any cause (up to 45.5 months)|DFS was evaluated on all qualified enrolled patients who received at least 1 dose of study medication. Criteria=histological or cytological diagnosis of non-small cell lung cancer (NSCLC) IB-IIIA; presence of measurable disease; no previous NSCLC chemotherapy and radiotherapy.||months||95% Confidence Interval|Median
711966|NCT00191308|Secondary|Duration of Response|The duration of response was defined as the time from complete response (CR) or partial response (PR) to disease progression. Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD)=20% increase in sum of longest diameter of target lesions.|Time of response to disease progression (up to 44.4 months)|Duration of response was analyzed on responders treated with at least 1 dose of study medication. Criteria=histological or cytological diagnosis of non-small cell lung cancer (NSCLC) IB-IIIA; presence of measurable disease; no previous NSCLC chemotherapy and radiotherapy; responder.||months||95% Confidence Interval|Median
711967|NCT00191308|Secondary|Percentage of Participants With Objective Tumor Response (Response Rate)|Tumor response to treatment using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD)=20% increase in sum of longest diameter of target lesions; Stable Disease (SD)=small changes that do not meet above criteria. Response rate was estimated as the total number of CR or PR, divided by the total number of participants treated.|Treatment start to disease progression or surgery (4-8 weeks after last dose of pemetrexed)|Tumor response rate and 95% confidence interval (CI) of best CR or PR were evaluated on all qualified enrolled participants treated with at least 1 dose of study medication. Criteria=histological or cytological diagnosis of non-small cell lung cancer (NSCLC) IB-IIIA; presence of measurable disease; no previous NSCLC chemotherapy and radiotherapy.||percentage of participants||95% Confidence Interval|Number
711968|NCT00191308|Primary|High/Low Expression of Selected Molecular Markers in Tumor Tissues and Hypermethylated Genes in Peripheral Blood|Molecular markers assessed by immunohistochemistry: thymidylate synthase, glycinamide ribonucleotide formyl transferase (GARFT), epidermal growth factor receptor (EGFR); and by polymerase chain reaction: dihydrofolate reductase (DHFR), dihydropyrimidine dehydrogenase (DPD), folylpolyglutamate synthetase (FPGS), reduced folate carrier, alpha folate receptor, Excision Repair Cross-Complementation Group 1 (ERCC1), folylpolyglutamate hydrolase (FPGH). Hypermethylated genes assessed by methylation-specific polymerase chain reaction. Due to small sample size, tumor-tissue analyses were not done.|Baseline, Cycle 2, and surgery (4-8 weeks after last dose of pemetrexed)|Due to lack of eligible participants, enrollment was stopped early when 30 participants were enrolled. Tumor samples were collected in only 19 of these 30 participants. Results obtained from analyses of a small number of available samples were considered to be of little scientific and medical relevance, and tumor-tissue analyses were not conducted.||participants|||Number
711969|NCT00191334|Secondary|Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade|Grades range from 0 (no toxicity) to 4 (life-threatening or disabling).|every 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up|||participants|||Number
711970|NCT00191334|Secondary|Time to Treatment Failure|Defined as the time from study enrollment to the first observation of disease progression, death as a result of any cause, or early discontinuation of treatment. Time to treatment failure was censored at the date of the last follow-up visit for patients who did not discontinue early, who were still alive, and who have not progressed.|every other 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up|||weeks||95% Confidence Interval|Median
721294|NCT00307047|Secondary|Ischemia Driven Target Vessel Failure (TVF)|Defined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR|3 years|ITT, @ 3 years||percentage of participants|||Number
711973|NCT00191334|Primary|Best Overall Tumor Response|Best response recorded from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started).|every other 21 day cycle (6-8 cycles), every 3 months during long-term follow-up|||participants|||Number
711974|NCT00191386|Secondary|Cytochrome P450 2D6 (CYP2D6) Phenotype Status|Participants were categorized as either extensive metabolizers (EM) or poor metabolizers (PM). CYP2D6 is the primary atomoxetine metabolizing enzyme. The CYP2D6 genotype were analysed by testing the *2, *3, *4, *5, *6, *7, *8, and *10 alleles. Metabolizer status was determined by focusing on the normal(wild type, *2), decreased(*10), and defective allele(*3, *4, *5, *6, *7, or *8). PM were assigned to the patients had two defective alleles in any combination of *3, *4, *5, *6, *7, or *8 alleles. EM was all except for PM.|Over 1 year|Full Analysis Set: Participants who met Study LYBC criteria, took 1 dose of drug, had a baseline/post-baseline measurement. Changes from baseline used LOCF approach. Baseline was the last non-missing measurement before taking atomoxetine (either LYDA Week 0 or LYBC Week 2). Endpoint was the last non-missing measurement in each assessment period.||Participants|||Number
711975|NCT00191386|Secondary|Change From Baseline at Various Timepoints in the Clinical Global Impressions-Attention Deficit Hyperactivity Disorder-Severity (CGI-ADHD-S)|Measures severity of the participant's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).|Baseline, 6 Months, 12 Months, 2 Years, 3 Years, 4 Years|Full Analysis Set: Participants who met Study LYBC criteria, took 1 dose of drug, had a baseline/post-baseline measurement. Changes from baseline used LOCF approach. Baseline was the last non-missing measurement before taking atomoxetine (either LYDA Week 0 or LYBC Week 2). Endpoint was the last non-missing measurement in each assessment period.||Units on a scale||Standard Deviation|Mean
711976|NCT00191386|Secondary|Change From Baseline at Various Timepoints in Attention Deficit Hyperactivity Disorder Rating Scale-IV-Translated in Japanese Parent Version: Investigator Administered and Scored (ADHDRS-IV-J:I) Total Score|Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54.|Baseline, 6 Months, 12 Months, 2 Years, 3 Years, 4 Years|Full Analysis Set: Participants who met Study LYBC criteria, took 1 dose of drug, had a baseline/post-baseline measurement. Changes from baseline used LOCF approach. Baseline was the last non-missing measurement before taking atomoxetine (either LYDA Week 0 or LYBC Week 2). Endpoint was the last non-missing measurement in each assessment period.||Units on a scale||Standard Deviation|Mean
711977|NCT00191386|Primary|Number of Participants With Adverse Events for Long Term Safety and Tolerability|Details on the actual adverse events are presented in the Reported Adverse Events Section.|Baseline through 4 years|All patients who took at least one dose of study medication were included in the analyses of safety data.||Participants|||Number
711978|NCT00191451|Secondary|Percentage of Patients With Overall Survival at 1 Year and 2 Years|Kaplan-Meier estimates of overall survival (percentage of patients surviving) at 1 year and 2 years.|1 Year, 2 Years|Intent to treat population: all randomized patients. Censored patients: 31 HER2+; 19 HER2- (Taxane-); 9 HER2- (Taxane+).||percentage of participants|||Number
711979|NCT00191451|Secondary|Time to Disease Progression (TTP)|If a patient is lost to follow-up, the patient will be censored as of the last date of contact. Patients who start a new treatment before they progress will be censored as of the date of start of the new treatment. If a patient died due to reason other than study disease, and patient has not progressed or received any new treatment, TTP is censored at the date of death.|randomization date to the earliest date of the first documented disease progression date or the date of death if the patient dies due to study disease (up to 3.5 years)|Intent to treat population: all randomized patients. Censored patients: 10 in HER2+, 20 in HER2- (Taxane-), and 12 in HER2- (Taxane+).||months||95% Confidence Interval|Median
711980|NCT00191451|Secondary|Number of Patients Who Experienced Alopecia||Baseline to 3.5 years|Number of patients who received at least one dose of study drug.||participants|||Number
711981|NCT00191451|Secondary|Duration of Response|Among tumor responders, the duration of tumor response is measured from the date of response (complete response [CR] or partial response [PR]) until the first date of documented progression or death from any cause. Duration of tumor response will be censored at the date of the last follow-up visit for tumor responders who are still alive and who have not progressed.|date of response (CR or PR) until the first date of documented progression or death from any cause (up to 3.5 years)|Number of patients with complete or partial response. Censored patients: 6 in HER2+, 6 in HER2- (Taxane-), and 5 in HER2- (Taxane+).||months||Full Range|Median
711982|NCT00191451|Primary|Overall Tumor Response|Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.|baseline to disease progression/recurrence (up to 3.5 years)|Efficacy evaluable subjects include all subjects who received at least 2 cycles of treatment with at least 1 follow-up tumor assessment, and did not violate the protocol in any fundamental manner related to the evaluation of efficacy.||participants|||Number
711983|NCT00191477|Secondary|Tumor Recurrence Type|Tumor recurrence type (superficial, stage pTA or pT1; or muscle-invasive, stage≥pT2) was classified according to American Joint Committee on Cancer Staging Criteria for Bladder Cancer (AJCC Cancer Staging Manual, 6th edition).|Surgery to recurrence (Follow-up assessments were performed at 3 and 6 months after the first TUR-BT, and every 6 months thereafter, until recurrence/progression of disease, or until the end of study, up to 24 months)|Efficacy Eligible population consists of the Full Analysis Set participants with histopathologically confirmed papillary superficial transitional cell carcinoma of the bladder.||participants|||Number
712017|NCT00191854|Secondary|Progression Free Survival (PFS)|PFS was defined as the time from randomizaton to the date of documented disease progression or death on study, whichever occurred first. PFS for participants who discontinued from the study or who had not progressed at the time of analysis were treated as censored at the date of the last tumor assessment.|baseline to measured progressive disease or death (tumor assessments were performed every 4 cycles during study therapy, or 3 months during post-therapy until disease progression, death, or up to 24 months after randomization)|Number of randomized patients. Censored patients: Gemcitabine + Paclitaxel = 20; Gemcitabine + Carboplatin = 18; Gemcitabine + Cisplatin = 28.||months||95% Confidence Interval|Median
711984|NCT00191477|Secondary|Recurrence-Free Survival (RFS) in Subgroups|Defined as the time from study enrollment to the date of the first procedure confirming histopathological recurrence or disease progression or death from any cause. Recurrence-free survival was censored at the date of the last follow-up visit for participants who were still alive and who had no recurrence/progression.|Surgery to recurrence or death (Follow-up assessments were performed at 3 and 6 months after the first TUR-BT, and every 6 months thereafter, until recurrence/progression of disease, or until the end of study, up to 24 months)|Because median time for RFS was not reached in all subgroups, patients (%) with RFS are reported as post-hoc outcome #6. There was no statistically significant difference between treatment arms in any subgroup. Population consists of randomized patients with histopathologically confirmed papillary superficial transitional cell carcinoma of bladder.||months||Full Range|Median
711985|NCT00191477|Secondary|Time to Recurrence|Time from enrollment to first confirmation of histopathological recurrence or disease progression. Time to recurrence was censored on date of death for patients who died, and on date of last visit for patients who were alive, without recurrence.|Surgery to recurrence (Follow-up assessments were performed at 3 and 6 months after the first TUR-BT, and every 6 months thereafter, until recurrence/progression of disease, or until the end of study, up to 24 months)|Because median time to recurrence was not reached in placebo arm, percentages of participants without recurrence are reported as post-hoc outcome measure (see #5. Post-hoc Outcome Measure). Efficacy Eligible population consists of randomized patients with histopathologically confirmed papillary superficial transitional cell carcinoma of bladder.||months||Full Range|Median
711986|NCT00191477|Post-Hoc|Percentage of Participants in Subgroups With Recurrence-Free Survival (RFS) at 12 and 24 Months|RFS rate was estimated using Kaplan-Meier method. RFS was analyzed in different subgroups based on risk, disease status, and concomitant Bacillus Calmette-Guerin (BCG) instillations. Risk: Grading (G1,G2,G3) was performed according to American Joint Committee on Cancer Staging Criteria for Bladder Cancer. Newly diagnosed disease: Initial diagnosis at study entry. Recurrent disease: history of at least one superficial bladder tumor that was surgically treated and relapsed prior to study entry. With BCG: received at least one instillation of BCG during study. Without BCG: didn't receive BCG.|Surgery to recurrence or death (Follow-up assessments were performed at 3 and 6 months after the first TUR-BT, and every 6 months thereafter, until recurrence/progression of disease, or until the end of study, up to 24 months)|Efficacy Eligible population consists of the Full Analysis Set (randomized) participants with histopathologically confirmed papillary superficial transitional cell carcinoma of the bladder.||percentage of participants|||Number
711987|NCT00191477|Post-Hoc|Percentage of Participants Without Tumor Recurrence|Because median time to recurrence was not reached, percentage of participants without event was estimated using Kaplan-Meier method. Time to recurrence was censored on date of death for patients who died, and on date of last visit for patients who were alive, without recurrence.|Surgery to recurrence (Follow-up assessments were performed at 3 and 6 months after the first TUR-BT, and every 6 months thereafter, until recurrence/progression of disease, or until the end of study, up to 24 months)|Efficacy Eligible population contains the Full Analysis Set participants with histopathologically confirmed papillary superficial transitional cell carcinoma of the bladder.||percentage of participants|||Number
711988|NCT00191477|Primary|Recurrence-Free Survival (RFS)|Defined as the time from study enrollment to the date of the first procedure confirming histopathological recurrence or disease progression or death from any cause. Recurrence-free survival (RFS) was censored at the date of the last follow-up visit for participants who were still alive and who had no recurrence/progression.|Surgery to recurrence or death (Follow-up assessments were performed at 3 and 6 months after the first TUR-BT, and every 6 months thereafter, until recurrence/progression of disease, or until the end of study, up to 24 months)|This is the Full Analysis Set population and contains all randomized participants who received the single instillation of Gemcitabine or Placebo.||Months||Full Range|Median
711989|NCT00191646|Secondary|Overall Survival|Overall survival is defined as the duration from baseline to death. For participants who are still alive at the data cut-off date, survival will be censored at the last contact date. Results are presented as a comparison between the two study treatment sequences (induction therapy followed by elective consolidation or crossover therapy) rather than the two induction therapies.|Baseline to death from any cause up to 82 months|Intent to treat (ITT) population, which includes all randomized participants. 3 participants in the Gemcitabine/Carboplatin treatment sequence were excluded due to missing data, and 1 participant in the Paclitaxel/Carboplatin treatment sequence was excluded for missing data. G/C Arm: 194 events, 220 censored. P/C Arm: 159 events, 254 censored.||months||95% Confidence Interval|Median
711990|NCT00191646|Secondary|Time to Treatment Failure|Time to treatment failure was defined as the duration from date of randomization to the date of the first of the following events: early discontinuation of study therapy; progression of disease, or death due to any cause. Time to treatment failure will be censored at the date of the last follow-up visit for participants who did not discontinue early, who are still alive, and who have not progressed. Results are presented as a comparison between the two study treatment sequences (induction therapy followed by elective consolidation or crossover therapy) rather than the two induction therapies.|Baseline to stopping treatment up to 82 months|Intent to treat (ITT) population, which includes all randomized participants. 3 participants in the Gemcitabine/Carboplatin treatment sequence were excluded due to missing data, and 1 participant in the Paclitaxel/Carboplatin treatment sequence was excluded for missing data. G/C Arm: 336 events, 78 censored. P/C Arm: 330 events, 83 censored.||months||95% Confidence Interval|Median
711991|NCT00191646|Secondary|Proportion of Participants With Response (Response Rate)|Response rate (RR) = proportion of participants with best overall Complete Response (CR: disappearance of all target lesions [TL]) or Partial Response (PR: 30% decrease in sum of longest diameter of TL). Induction therapy RR = number of participants with CR or PR during induction divided by number of participants with measurable disease at baseline (TL measurement during screening). Crossover therapy RR = number of participants with CR or PR during crossover divided by number of participants with measurable disease at baseline (latest TL measurement by first dose date of crossover therapy).|Baseline to measured progressive disease up to 82 months|All ITT participants with measurable disease at baseline (screening) for induction period; all ITT participants who crossed over to single agent therapy and had measurable disease before or at crossover for crossover period. Participants in consolidation therapy achieved CR during induction therapy and were not included in analysis.||proportion of responders||95% Confidence Interval|Mean
711992|NCT00191646|Primary|Progression Free Survival (PFS)|Progression free survival was defined as the duration from the date of randomization to the first date of documented disease progression or death from any cause. Tumor assessments were performed every three 21-day cycles during induction and crossover. Progression free survival was censored at the date of the last follow-up visit for participants who were still alive and who had not progressed. Results are presented as a comparison between the two study treatment sequences (induction therapy followed by elective consolidation or crossover therapy) rather than the two induction therapies.|Baseline to measured progressive disease or death up to 82 months|Intent to treat (ITT) population, which includes all randomized participants. 3 participants in the Gemcitabine/Carboplatin treatment sequence were excluded due to missing data, and 1 participant in the Paclitaxel/Carboplatin treatment sequence was excluded for missing data. G/C Arm: 292 events, 122 censored. P/C Arm: 279 events, 134 censored.||Months||95% Confidence Interval|Median
711993|NCT00191724|Secondary|Difference in Pulmonary Artery (PA) Pressure|Investigator decided estimate of pulmonary artery pressure by echocardiography would not be useful and no data on pulmonary artery pressure were collected.|baseline, day 6, day 90|Data were not collected.||mm Hg||Standard Deviation|Mean
711994|NCT00191724|Secondary|Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS of the McMaster University Canada)|Scores in each of the 4 domains (dyspnea, fatigue, emotional, and mastery) ranged from 1 (maximum impairment) to 7 (no impairment).|baseline and day 90 (follow-up)|Population was all randomized patients who received any study drug [drotrecogin alfa (activated) or placebo]. Patients who had no postbaseline assessment were excluded from the analyses.||units on a scale||Standard Deviation|Mean
711995|NCT00191724|Secondary|Right Ventricular Enddiastolic Area/Left Ventricular Enddiastolic Area (RVEDA/LVEDA) Ratios|Change of right ventricular function measured as difference of right ventricular enddiastolic area/left ventricular enddiastolic area (RVEDA/LVEDA) ratios by echocardiography|baseline, day 6, day 90|Population is all randomized patients who received any amount of study drug [drotrecogin alfa (activated) or placebo]. Patients who had no postbaseline measure at Day 6 or Day 90 were excluded from the analysis of change from baseline to day 6 or day 90, respectively.||ratio||Standard Deviation|Mean
711996|NCT00191724|Primary|Number of Participants With Major Bleeding Events|Number of patients with major bleeding events, defined as: Reduction in hemoglobin of 2 to 5 grams per deciliter (g/dL) within 24 hours; Transfusion of 2 to 4 units of packed red blood cells within 24 hours; Hematoma requiring prolonged hospitalization or surgical intervention; Intracranial or retroperitoneal hemorrhage.|baseline through day 6|The population analyzed was all randomized patients who received any amount of study drug [drotrecogin alfa (activated) or placebo].||participants|||Number
711997|NCT00191789|Post-Hoc|Number of Participants With Time to Treatment Failure at Various Time Points|This outcome is in place of the time to treatment failure outcome. The cumulative number of participants with an event (disease progression, death as a result of any cause, or early discontinuation of treatment) are presented at various time points, as well as the number of participants at risk for the event. Participants at risk are the number of participants without disease progression, are alive, or did not discontinue treatment early at the beginning of each time point.|baseline to stopping treatment (up to 68 months)|Intent to treat population.||participants|||Number
711998|NCT00191789|Post-Hoc|Number of Participants Who Died From Any Cause at Various Time Points|The cumulative number of participants with an event (death from any cause) are presented at various time points, as well as the number of participants at risk for the event. Participants at risk are the number of participants still alive at the beginning of each time point.|baseline up to 68 months|Intent to treat population.||participants|||Number
711999|NCT00191789|Post-Hoc|Number of Participants With Progressive Disease or Death at Various Time Points Throughout the Study|The cumulative number of participants with an event (either progressive disease or death) are presented at various time points, as well as the number of participants at risk for the event. Participants at risk are the number of participants without progressive disease or still alive at the beginning of each time point.|baseline up to 68 months|Intent to treat population.||participants|||Number
712000|NCT00191789|Secondary|Number of Patients Eligible for Breast Conservation Surgery at Baseline and Number of Patients Undergoing Breast Conservation Surgery|The extent and type of surgery was guided by the tumor size, physician and/or patient decision. It was either conservation surgery or mastectomy with axillary lymph node dissection. Results are reported on the number of patients who underwent breast conservation surgery.|baseline, after eight 21-day cycles of study drug|||participiants|||Number
712001|NCT00191789|Secondary|Time to Treatment Failure|Time to treatment failure was defined as the time from study enrollment to the first observation of disease progression, death as a result of any cause, or early discontinuation of treatment. Time to treatment failure was censored at the date of the last follow-up visit for patients who did not discontinue early, who were still alive, and who have not progressed. Because the upper limit of the 95% Confidence Interval of median survival was not calculable, results are presented as the Outcome: Number of Participants with Time to Treatment Failure at Various Timepoints.|baseline to stopping treatment (up to 68 months)|Upper limit of 95% Confidence Interval of median survival was not calculable.||weeks||95% Confidence Interval|Median
712002|NCT00191789|Secondary|Overall Survival|Overall survival was defined as the date of enrollment to the date of death from any cause. Because the median was not reached, results will be presented as the Outcome: Number of Participants who Died from Any Cause at Various Timepoints.|baseline to date of death from any cause up to 68 months|Median was not reached||months||95% Confidence Interval|Median
712003|NCT00191789|Secondary|Progression Free Survival (PFS)|PFS was defined as the date of enrollment to the first date of documented disease progression or death from any cause. Because the median was not reached, results are presented as the Outcome: Number of Participants with Disease Progression or Death at Various Timepoints.|baseline to measured progressive disease or death from any cause (up to 68 months)|Median was not reached.||months||95% Confidence Interval|Median
712004|NCT00191789|Secondary|Summary of Deaths During Study||baseline through last cycle on study drug (eight 21-day cycles)|Intent to treat population.||participants|||Number
712053|NCT00191984|Secondary|Progression-Free Survival (PFS)|Defined as the time from study enrollment to the first date of disease progression or death as a result of any cause. PFS was censored at the date of the last follow-up visit for participants who were still alive and who had not progressed.|baseline to measured progressive disease or death (up to 2 years follow-up)|All enrolled participants with at least one completed cycle.||days||95% Confidence Interval|Median
712005|NCT00191789|Primary|Number of Patients With Pathological Complete Response (Pathological Complete Response Rate)|Complete pathological response: No invasive tumor cells identified from sections from site of previous cancer. Require evidence corroborating prior presence of invasive cancer, which requires detection of abnormal fibroelastic breast stroma devoid of normal lobular units and contains foamy macrophages with moderate numbers of fibroblasts and mononuclear inflammatory cells. Presence of nondescript collagenised lobules or breast fibrous tissue is not evidence that tumor site has been adequately sampled and macroscopic assessment and sampling is needed until original neoplastic stroma identified.|tumor assessment at baseline and during surgery after eight 21-day treatment cycles|Intent to treat population.||participants|||Number
712006|NCT00191815|Secondary|Number of Participants With Adverse Events Leading to Discontinuation||Baseline through eight 21-day cycles|Safety Population: all enrolled participants who received study drug.||participants|||Number
712007|NCT00191815|Secondary|Number of Deaths||Baseline through follow-up (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.)|All enrolled participants.||participants|||Number
712008|NCT00191815|Secondary|Number of Participants With Hematology Maximum Common Toxicity Criteria - National Cancer Institute Grades|Maximum CTC-NCI toxicity grade for hematology. Grades range from 0 (none) to 5 (death).|Baseline up to 30 days after last dose of study drug (eight 21-day cycles of therapy)|Safety Population: all enrolled participants who received study drug.||participants|||Number
712009|NCT00191815|Secondary|Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination|The CTC provides descriptive terminology for adverse event reporting. A grading (severity) scale is provided for each adverse event term. Grades range from 0 (none) to 5 (death).|Baseline up to 30 days after last dose of study drug (eight 21-day cycles of therapy)|Safety Population: all enrolled participants who received study drug.||participants|||Number
712010|NCT00191815|Secondary|Survival Time|Overall survival is the duration from enrollment to death due to any cause.|first active treatment dose to date of death due to any cause (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.)|Efficacy Population: all enrolled participants who received study drug; did not have more than one neoadjuvant/adjuvant chemotherapy; had measurable disease; had prior neoadjuvant/adjuvant chemotherapy; and did not have prior chemotherapy for metastatic disease.||weeks||95% Confidence Interval|Median
712011|NCT00191815|Secondary|Time to Treatment Failure|Defined as the time from study enrollment to the first observation of disease progression, death as a result of any cause, or early discontinuation of treatment.|first active treatment dose to last contact for patients, death as a result of any cause, or early discontinuation of treatment (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.)|Efficacy Population: all enrolled participants who received study drug; did not have more than one neoadjuvant/adjuvant chemotherapy; had measurable disease; had prior neoadjuvant/adjuvant chemotherapy; and did not have prior chemotherapy for metastatic disease.||weeks||95% Confidence Interval|Median
712012|NCT00191815|Secondary|Time to Progressive Disease|Defined as the time from study enrollment to the first date of disease progression.|first active treatment dose to measured progressive disease (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.)|Efficacy Population: all enrolled participants who received study drug; did not have more than one neoadjuvant/adjuvant chemotherapy; had measurable disease; had prior neoadjuvant/adjuvant chemotherapy; and did not have prior chemotherapy for metastatic disease.||weeks||95% Confidence Interval|Median
712013|NCT00191815|Secondary|Duration of Response|The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.|first documented complete or partial response to measured progressive disease (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.)|Response population: all enrolled participants who had either a complete or partial response.||weeks||95% Confidence Interval|Median
712014|NCT00191815|Primary|Objective Tumor Response|"Best response recorded from the start of treatment until disease progression/recurrence using World Health Organization (WHO) criteria that defines when participants improve (respond), stay the same (stable), or worsen (progression) during treatment."|baseline to measured progressive disease (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration. Data collected every 4 months.)|Efficacy Population: all enrolled participants who received study drug; did not have more than one neoadjuvant/adjuvant chemotherapy; had measurable disease; had prior neoadjuvant/adjuvant chemotherapy; and did not have prior chemotherapy for metastatic disease.||participants|||Number
712015|NCT00191854|Secondary|Overall Survival|Overall survival time is defined as the time from the date of randomization to date of death due to any cause. Survival time is censored at the date of last contact for patients who are still alive or lost to follow-up.|baseline to date of death from any cause (up to 34 months)|Number of randomized patients. Censored patients: Gemcitabine + Paclitaxel = 23; Gemcitabine + Carboplatin = 24; Gemcitabine + Cisplatin = 22.||months||Full Range|Median
712016|NCT00191854|Secondary|Duration of Response|Duration of response was measured from time of first documentation of complete response (disappearance of all target lesions) or partial response (30% decrease in sum of longest diameter of target lesions), until date of PFS. Duration of response was censored on day of last tumor assessment for patients who had not progressed or who had discontinued study at time of analysis, and for cases where investigator determined patient had progressive disease and discontinued study therapy and/or started a new, non-protocol-specified anti-cancer therapy before documented disease progression.|time of response to progressive disease or death (tumor assessments were performed every 4 cycles during study therapy, or 3 months during post-therapy until disease progression, death, or up to 24 months after randomization)|Randomized patients who had either a complete response or partial response. Censored patients: Gemcitabine + Paclitaxel = 4; Gemcitabine + Carboplatin = 4; Gemcitabine + Cisplatin = 14.||months||95% Confidence Interval|Median
712115|NCT00183456|Primary|Sex Risk Behaviors: Unprotected Anal Sex (Past 90 Days)||18 month|||participants|||Number
712116|NCT00183456|Secondary|HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)||12 months|||participants|||Number
712117|NCT00183456|Primary|Sex Risk Behaviors: Unprotected Sex With Non-main Partner (Past 90 Days)||12 months|||participants|||Number
712018|NCT00191854|Secondary|Number of Participants With a Time to Treatment Failure (TTTF) Event|TTTF event was defined as documented disease progression, death on study, start of non-protocol-specified anticancer therapy, or therapy discontinuation due to toxicity. TTTF for patients who were still participating in study without treatment failure at time of analysis were treated as censored at date of last tumor assessment. TTTF for patients who had discontinued from therapy for reasons other than toxicity and who did not experience treatment failure prior to therapy discontinuation were treated as censored on day of study discontinuation.|randomization to date of documented disease progression, death on study, start of non-protocol-specified anticancer therapy, or therapy discontinuation due to toxicity, whichever occurred first (up to 6 months)|Number of randomized patients. Censored patients: Gemcitabine + Paclitaxel = 34; Gemcitabine + Carboplatin = 26; Gemcitabine + Cisplatin = 30.||participants|||Number
712019|NCT00191854|Primary|Best Overall Response|Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.|baseline to measured progressive disease (tumor assessments were performed every 4 cycles during study therapy, or 3 months during post-therapy until disease progression, death or up to 24 months after randomization)|Number of all randomized participants.||participants|||Number
712020|NCT00191906|Secondary|Change From Baseline in Phonological Task Mean Reaction Time Comparison of ADHD-C+RD and RD to Reading Disordered Control Group in >=10 Year Old Subset: Pseudo Words|Measure of reaction time in determining whether the stimulus sounds like a real word ('yes' response) or not ('no' response) using pseudo homophones and pseudo words. Data presented here are for reaction time to indentifying pseudo words correctly.|Baseline and 4 weeks of therapy|All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.||milliseconds||Standard Deviation|Mean
712021|NCT00191906|Secondary|Change From Baseline in Phonological Task Mean Reaction Time Comparison of ADHD-C+RD and RD to Reading Disordered Control Group in >=10 Year Old Subset: Pseudohomophones|Measure of reaction time in determining whether the stimulus sounds like a real word ('yes' response) or not ('no' response) using pseudo homophones and pseudo words. Data presented here are for reaction time to identifying psuedohomophones correctly.|Baseline and 4 weeks of therapy|All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.||milliseconds||Standard Deviation|Mean
712022|NCT00191906|Secondary|Change From Baseline in Phonological Task Mean Reaction Time Comparison of ADHD-C to Normal Control Group in >=10 Year Old Subset: Pseudo Words|Measure of reaction time in determining whether the stimulus sounds like a real word ('yes' response) or not ('no' response) using pseudo homophones and pseudo words. Data presented here are for reaction time to identifying pseudo words correctly.|Baseline and 4 weeks of therapy|All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.||milliseconds||Standard Deviation|Mean
712023|NCT00191906|Secondary|Change From Baseline in Phonological Task Mean Reaction Time Comparison of ADHD-C to Normal Control Group in >=10 Year Old Subset: Pseudohomophones|Measure of reaction time in determining whether the stimulus sounds like a real word ('yes' response) or not ('no' response) using pseudohomophones and pseudo words. Data presented here are for reaction time to identifying psuedohomophones correctly.|Baseline and 4 weeks of therapy|All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.||milliseconds||Standard Deviation|Mean
712024|NCT00191906|Secondary|Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale|Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).|4 week therapy endpoint|All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.||units on a scale||Standard Error|Least Squares Mean
712025|NCT00191906|Secondary|Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Improvement Scale|Measures total improvement (or worsening) of a patient's ADHD symptoms from the beginning of treatment (1=very much improved, 7=very much worsened).|4 week therapy endpoint|All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.||units on a scale||Standard Error|Least Squares Mean
712026|NCT00191906|Secondary|Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Total T-Score|Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total score is computed as the sum of the scores on each of the 18 items. Total score is the sum of the scores on the 18 items and range from 0 to 54. Total T-score = (Total Score - 50)/10. Total T-score ranges from -5 (low severity) to 0.4 (high severity).|Baseline and Week 4 of initial therapy and Week 4 of crossover therapy|All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.||T-Score of units on a scale||Standard Error|Least Squares Mean
712027|NCT00191906|Secondary|Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Hyperactivity-Impulsivity Subscale|Measures the degree of hyperactivity-impulsivity symptoms, based on answers to 9 items. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often) for a total Hyperactivity-Impulsivity Subscale score of 0 to 27.|Baseline and Week 4 of initial therapy and Week 4 of crossover therapy|All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.||units on a scale||Standard Error|Least Squares Mean
712118|NCT00183456|Secondary|HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)||6 months|||participants|||Number
712028|NCT00191906|Secondary|Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Inattention Subscale|Measures the degree of inattention symptoms based on answers to 9 items. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often), for a total Inattention Subscale score range of 0 to 27.|Baseline and Week 4 of initial therapy and Week 4 of crossover therapy|All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.||units on a scale||Standard Error|Least Squares Mean
712029|NCT00191906|Secondary|Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Total Score|Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total score is the sum of the scores on the 18 items and range from 0 to 54.|Baseline and Week 4 of initial therapy and Week 4 of crossover therapy|All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.||units on a scale||Standard Error|Least Squares Mean
712030|NCT00191906|Secondary|Working Memory by Corsi Block Tapping Test (CBTT)|Measures the visuo-spatial working memory span, and corresponds to the longest sequence of blocks that has been reproduced correctly at least once. Scores can range from 3 to 8, with the higher score indicating better function.|Baseline and Week 4 of initial therapy and Week 4 of crossover therapy|All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.||blocks correctly sequenced||Standard Error|Least Squares Mean
712031|NCT00191906|Secondary|Lexical Decision Task Mean Reaction Time: Pseudo Words|Measure of reaction time to identify whether a word displayed on a computer is a pseudo word versus a real or correct word. During the performance of the lexical decision task that was presented on a computer, the reaction times and accuracy of responses were measured. Data presented are the mean reaction times over the 4 weeks of each therapy for identifying pseudo words correctly.|Baseline and Week 4 of initial therapy and Week 4 of crossover therapy|All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.||milliseconds||Standard Error|Least Squares Mean
712032|NCT00191906|Secondary|Lexical Decision Task Mean Reaction Time: Correct Words|Measure of reaction time to identify whether a word displayed on a computer is a real or correct word versus a pseudo word. During the performance of the lexical decision task that was presented on a computer, the reaction times and accuracy of responses were measured. Data presented are the mean reaction times over the 4 weeks of each therapy for identifying correct words correctly.|Baseline and Week 4 of initial therapy and Week 4 of crossover therapy|All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.||milliseconds||Standard Error|Least Squares Mean
712033|NCT00191906|Secondary|Change From Baseline in Mean Stop Signal Reaction Time Comparison of ADHD-C+RD and RD to Reading Disordered Control Group in >=10 Year Old Subset|SSRT measures response execution (go trials) and response inhibition (stop trials). Go trials consist of stimulus (airplane). Child to press response button corresponding to direction airplane is pointing. Stop trials consist of go trial and audible stop signal. Initial delay between go trial and stop signal = 250 msec. If child succeeded in inhibiting response, delay on next stop trial increased by 50 msec, otherwise, delay decreased by 50 msec. SSRT = subtract mean delay from mean go signal reaction time. Lower scores mean better ability to suppress response when presented with stop signal.|Baseline and 4 weeks of therapy|All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.||milliseconds||Standard Deviation|Mean
712034|NCT00191906|Secondary|Change From Baseline in Mean Stop Signal Reaction Time Comparison of ADHD-C to Normal Control Group in >=10 Year Old Subset|SSRT measures response execution (go trials) and response inhibition (stop trials). Go trials consist of stimulus (airplane). Child to press response button corresponding to direction airplane is pointing. Stop trials consist of go trial and audible stop signal. Initial delay between go trial and stop signal = 250 msec. If child succeeded in inhibiting response, delay on next stop trial increased by 50 msec, otherwise, delay decreased by 50 msec. SSRT = subtract mean delay from mean go signal reaction time. Lower scores mean better ability to suppress response when presented with stop signal.|Baseline and 4 weeks of therapy|All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.||milliseconds||Standard Deviation|Mean
712035|NCT00191906|Primary|Stop Signal Reaction Time (SSRT) as Derived From the Stop Signal Reaction Time Paradigm|SSRT measures response execution (go trials) and response inhibition (stop trials). Go trials consist of stimulus (airplane). Child to press response button corresponding to direction airplane is pointing. Stop trials consist of go trial and audible stop signal. Initial delay between go trial and stop signal = 250 msec. If child succeeded in inhibiting response, delay on next stop trial increased by 50 msec, otherwise, delay decreased by 50 msec. SSRT = subtract mean delay from mean go signal reaction time. Lower scores mean better ability to suppress response when presented with stop signal.|Baseline and Week 4 of initial therapy and Week 4 of crossover therapy|All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.||milliseconds (msec)||Standard Error|Least Squares Mean
712036|NCT00191945|Secondary|Vital Signs - Weight||Baseline and 12 weeks|All randomized participants.||kilograms||Standard Deviation|Mean
712037|NCT00191945|Secondary|Vital Signs - Pulse||Baseline and 12 weeks|All randomized participants.||beats per minute||Standard Deviation|Mean
712038|NCT00191945|Secondary|Vital Signs - Diastolic Blood Pressure||Baseline and 12 weeks|All randomized participants.||mmHg||Standard Deviation|Mean
712039|NCT00191945|Secondary|Vital Signs - Systolic Blood Pressure||Baseline and 12 weeks|All randomized participants.||mmHg||Standard Deviation|Mean
712119|NCT00183456|Primary|Sex Risk Behaviors: Number of Sex Partners (>=2 Sex Partners)|Number of participants that had 2 or more sex partners in the past 90 days.|6 months|||participants|||Number
712040|NCT00191945|Secondary|Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) at 107 Weeks (Open-Label Extension)|Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54.|Week 107|Intention to Treat analysis. Last observation carried forward.||units on a scale||Standard Deviation|Mean
712041|NCT00191945|Secondary|Kiddie Schedule for Affective Disorders and Schizophrenia for School Aged Children-Present and Lifetime Version (K-SADS-PL)|The K-SADS-PL is a semi-structured interview schedule for assessing psychiatric disorders in children and adolescents. It is used to assess the status of 32 DSM-IV child and adolescent psychiatric diagnosis.|Baseline|Intention to Treat analysis. All randomized participants who took at least one dose of study drug.||participants|||Number
712042|NCT00191945|Secondary|Child Health and Illness Profile (CHIP) Change From Baseline to Endpoint (12 Weeks)|Parent-rated assessment of a child’s health status and level of functioning. It consists of 76 items. The majority of items assess frequency of activities or feelings using a five-point response format (for example, ‘how good is your child at making friends?’ 1=never, 5=always). Standard scores (t-value) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Standard scores are expressed in standard deviation units. T-score=[(Score-4.2382)*10/0.32835]+50. Higher scores mean improvement.|Baseline to 12 weeks|Intention to Treat analysis. Last observation carried forward.||standard deviation units||Standard Deviation|Mean
712043|NCT00191945|Secondary|Conners' Parent Rating Scale-Revised: Short Form (CPRS-R:S) Total Score Changes From Baseline to Endpoint (Week 12)|The CPRS-R:S has 27 items to be completed by the parent to assess behavioral problems related to ADHD. Individual item scores range from 0 (not at all true/never/seldom: lowest impairment) to 3 (very much true/very often/very frequent: highest impairment). The total score is calculated as the sum of all items. Total scores range from 0 to 81.|Baseline and Week 12|Intention to Treat analysis. Last observation carried forward.||units on a scale||Standard Deviation|Mean
712044|NCT00191945|Secondary|Clinical Global Impressions- Attention-Deficit/Hyperactivity Disorder-Severity Change From Baseline to Endpoint (Visit 18) of the Open-Label Extension (107 Weeks)|Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).|Baseline and Open-Label Endpoint (107 weeks)|Intention to Treat analysis. Last observation carried forward.||units on a scale||Standard Deviation|Mean
712045|NCT00191945|Secondary|Clinical Global Impressions- Attention-Deficit/Hyperactivity Disorder-Severity Changes From Baseline to Visit 7 (12 Weeks)|Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).|Baseline and 12 weeks|Intention to Treat analysis. Single item missing scores were imputed with the mean score of the remaining items when computing subscale and total scores.||units on a scale||Standard Deviation|Mean
712046|NCT00191945|Secondary|Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score Change From Week 6 to Week 12|Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54.|week 6 and week 12|Intention to Treat analysis. Single item missing scores were imputed with the mean score of the remaining items when computing subscale and total scores.||units on a scale||Standard Deviation|Mean
712047|NCT00191945|Secondary|Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 4 Weeks|Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54.|Week 4|Intention to Treat analysis. Single item missing scores were imputed with the mean score of the remaining items when computing subscale and total scores.||units on a scale||Standard Deviation|Mean
712048|NCT00191945|Secondary|Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 6 Weeks|Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54.|Week 6|Intention to Treat analysis. Single item missing scores were imputed with the mean score of the remaining items when computing subscale and total scores.||units on a scale||Standard Deviation|Mean
712049|NCT00191945|Secondary|Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 9 Weeks|Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54.|Week 9|Intention to Treat analysis. Single item missing scores were imputed with the mean score of the remaining items when computing subscale and total scores.||units on a scale||Standard Deviation|Mean
712050|NCT00191945|Primary|Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 12 Week Endpoint|Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total Scores range from 0 to 54.|Week 12|Intention to Treat analysis. Single item missing scores were imputed with the mean score of the remaining items when computing subscale and total scores.||units on a scale||Standard Deviation|Mean
712051|NCT00191984|Secondary|Overall Survival|Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.|baseline to date of death from any cause (up to 2 years follow-up)|All enrolled participants with at least one completed cycle.||days||95% Confidence Interval|Median
712052|NCT00191984|Secondary|Time to Treatment Failure|Defined as the time from study enrollment to the first observation of disease progression, death as a result of any cause, or early discontinuation of treatment. Time to treatment failure was censored at the date of the last follow-up visit for patients who did not discontinue early, who were still alive, and who have not progressed.|baseline to stopping treatment (up to 2 years follow-up)|All enrolled participants with at least one completed cycle.||days||95% Confidence Interval|Median
712054|NCT00191984|Secondary|Duration of Response|"The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. Response was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve (respond), stay the same (stable), or worsen (progression) during treatment.
Complete response (CR) = disappearance of all target lesions. Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions."|time of response to progressive disease or death (up to 2 years follow-up)|All enrolled participants with at least completed cycle and who had a complete or partial response.||days||95% Confidence Interval|Median
712055|NCT00191984|Primary|Best Overall Tumor Response|"Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve (respond), stay the same (stable), or worsen (progression) during treatment.
Complete response (CR) = disappearance of all target lesions. Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions.
Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions. Stable disease (SD) = small changes that do not meet above criteria."|baseline to measured progressive disease (up to 2 years follow-up)|All enrolled participants with at least one completed cycle.||participants|||Number
712056|NCT00192023|Other Pre-specified|Open-Label Phase Nonserious Adverse Events|Number of participants with nonserious adverse events during the open-label phase of the trial, which was for 1.5 years or until atomoxetine received marketing approval.|Baseline (Visit 14) though 1.5 years (Visit 20) or until atomoxetine received marketing approval|Number of patients who entered this optional open-label phase. All of the patients were dispensed drug.||participants|||Number
712057|NCT00192023|Other Pre-specified|Open-Label Phase Serious Adverse Events|Number of participants with serious adverse events during the open-label phase of the trial, which was for 1.5 years or until atomoxetine received marketing approval.|Baseline (Visit 14) though 1.5 years (Visit 20) or until atomoxetine received marketing approval|Number of patients who entered this optional open-label phase. All of the patients were dispensed drug.||participants|||Number
712058|NCT00192023|Secondary|Change From Baseline to 8 Week Endpoint in Conners' Teacher Rating Scale-Revised: Short Form Subscale Scores|A 28-item rating scale (0 [not at all/never] to 3 [very much true/very often]) completed by the teacher to assess problem behaviors related to ADHD. Subscale total scores range from 0 to 15 for Oppositional and Cognitive Problems, 0 to 21 for Hyperactivity, and 0 to 36 for ADHD Index.|Visit 8 (baseline) and Visit 14 (8 weeks)|Efficacy Population (All 139 randomized patients with at least a post-baseline value for the primary endpoint, i.e., 105 + 32 = 137 patients in total). Last Observation Carried Forward was applied. Missing data were not imputed, which generates different analysis population sizes for the different endpoints.||units on a scale||Standard Deviation|Mean
712059|NCT00192023|Secondary|Change From Baseline to 8 Week Endpoint in Child Health and Illness Profile - Child Edition (CHIP-CE): Parent Rated Form|Parent-rated assessment of a child’s health status and level of functioning. It consists of 76 items. The majority of items assess frequency of activities or feelings using a five-point response format (for example, ‘how good is your child at making friends?’ 1=never, 5=always). Standard scores (t-value) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Standard scores are expressed in standard deviation units. T-score=[(score-4.2382)*10/0.32835] + 50. Higher scores mean improvement.|Visit 8 (baseline) and Visit 14 (8 weeks)|Efficacy Population (All 139 randomized patients with at least a post-baseline value for the primary endpoint, i.e., 105 + 32 = 137 patients in total). Last Observation Carried Forward was applied. Missing data were not imputed, which generates different analysis population sizes for the different endpoints.||standard deviation units||Standard Deviation|Mean
712060|NCT00192023|Secondary|Change From Baseline to 8 Week Endpoint in Conners' Parent Rating Scale-Revised: Short Form Subscale Scores|A 27-item rating scale (0 [not at all/never] to 3 [very much true/very often]) completed by the parent to assess problem behaviors related to ADHD. Subscales: Oppositional, Cognitive Problems, Hyperactivity, and ADHD Index. Subscale total scores range from 0 to 18 for all subscales except ADHD Index which ranges from 0 to 36.|Visit 8 (baseline) and Visit 14 (8 weeks)|Efficacy Population (All 139 randomized patients with at least a post-baseline value for the primary endpoint, i.e., 105 + 32 = 137 patients in total). Last Observation Carried Forward was applied. Missing data were not imputed, which generates different analysis population sizes for the different endpoints.||units on a scale||Standard Deviation|Mean
712061|NCT00192023|Secondary|Change From Baseline to 8 Week Endpoint in Children's Depression Rating Scale-Revised|Measures presence and severity of depression. Consists of 17 items scored on a 1-5 or 1-7 scale. A rating of 1 indicates normal, thus the minimum score is 17. The maximum score is 113. In general, scores below 20 indicate an absence of depression; scores of 20 or 30 indicate borderline depression; scores of 40 to 60 indicate moderate depression.|Visit 8 (baseline) and Visit 14 (8 weeks)|Efficacy Population (All 139 randomized patients with at least a post-baseline value for the primary endpoint, i.e, 105 + 32 = 137 patients in total). Last Observation Carried Forward was applied.||units on a scale||Standard Deviation|Mean
712062|NCT00192023|Secondary|Change From Baseline to 8 Week Endpoint in Screen for Child Anxiety Related Emotional Disorders (SCARED) Total Score|The scale measures symptoms of DSM-IV linked anxiety disorders in children. Contains 41 items. Individual item scores range from 0 (not true or hardly ever true) to 2 (very true or often true). Therefore, the overall score ranges from 0 to 82. Higher scores are more indicative of greater anxiety.|Visit 8 (baseline) and Visit 14 (8 weeks)|Efficacy Population (All 139 randomized patients with at least a post-baseline value for the primary endpoint, i.e., 105 + 32 = 137 patients in total). Last Observation Carried Forward was applied. Missing data were not imputed, which generates different analysis population sizes for the different endpoints.||units on a scale||Standard Deviation|Mean
712063|NCT00192023|Secondary|Change From Baseline to 8 Week Endpoint in SNAP-IV Oppositional Subscale|Items are included from the DSM-IV criteria for Oppositional Defiant Disorder (items #21-#28). The SNAP-IV is based on a 0 (not at all) to 3 (very much) rating scale. Total subscale scores range from 0 to 24.|Visit 8 (baseline) and Visit 14 (8 weeks)|Efficacy Population (All 139 randomized patients with at least a post-baseline value for the primary endpoint, i.e, 105 + 32 = 137 patients in total). Last Observation Carried Forward was applied.||units on a scale||Standard Deviation|Mean
712064|NCT00192023|Secondary|Change From Baseline to 8 Week Endpoint in Clinical Global Impressions - Attention-Deficit/Hyperactivity Disorder (ADHD) - Severity|Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients.|Visit 8 (baseline) and Visit 14 (8 weeks)|Efficacy Population (All 139 randomized patients with at least a post-baseline value for the primary endpoint, i.e, 105 + 32 = 137 patients in total). Last Observation Carried Forward was applied.||units on a scale||Standard Deviation|Mean
712065|NCT00192023|Primary|Change From Baseline to 8 Week Endpoint in Swanson, Nolan and Pelham Questionnaire (SNAP-IV): Attention-Deficit/Hyperactivity Disorder (ADHD) Subscale|Items from the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for ADHD are included for the two subsets of symptoms: inattention (items #1-#9) and hyperactivity/impulsivity (items #11-#19). The SNAP-IV is based on a 0 (not at all) to 3 (very much) rating scale. Total subscale scores range from 0 to 54.|Visit 8 (baseline) and Visit 14 (8 weeks)|Efficacy Population (All 139 randomized patients with at least a post-baseline value for the primary endpoint, i.e, 105 + 32 = 137 patients in total). Last Observation Carried Forward was applied.||units on a scale||Standard Deviation|Mean
712066|NCT00192036|Secondary|Safety of Chemo-radiotherapy|A grading (severity) scale is provided for each adverse event term. Toxicities were graded according to NCI-CTC Version 2.0 grading scales. For specific radiation events, Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer late radiation toxicity scale was used. Grades range from 0 (none) to 5 (death). Number of participants with clinically significant acute Grade 3 and Grade 4 toxicities (worst severity) occurring during chemo-radiation and up to 49 days (8 weeks) after are reported. Grade 3 events are severe and Grade 4 events are life-threatening.|Cycles 4 and 5 up to 8 weeks after the end of chemo-radiotherapy|All enrolled participants receiving chemo-radiotherapy (Cycle 4).||participants|||Number
712067|NCT00192036|Secondary|Safety of Induction Chemotherapy|A grading (severity) scale is provided for each adverse event term. Toxicities were graded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) Version 2.0 grading scales. Grades range from 0 (none) to 5 (death). Number of participants with clinically significant Grade 3 and Grade 4 toxicities occurring during induction chemotherapy are reported. Grade 3 events are severe and Grade 4 events are life-threatening.|every cycle (21 days) for 3 cycles (up to 10 weeks)|All enrolled participants.||participants|||Number
712068|NCT00192036|Secondary|Overall Survival|Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.|Preliminary: baseline to date of death from any cause (up to 3.5 years); Final: baseline to date of death from any cause (up to 5 years)|All enrolled participants.||months||Full Range|Median
712069|NCT00192036|Secondary|Time to Progressive Disease|Time to progressive disease is the time from the date of enrollment to the first date of documented disease progression. Patients who have not had disease progression will be censored at the date of the last follow-up visit. Patients dying because of reasons other than tumor progression are not included.|Preliminary: baseline to measured progressive disease (up to 3.5 years); Final: baseline to measured progressive disease (up to 5 years);|All enrolled participants.||months||Full Range|Median
712070|NCT00192036|Primary|Tumor Response at End of Treatment|Response recorded at the first follow-up visit using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.|baseline to first follow-up visit (up to 8 weeks after end of chemo-radiation)|All enrolled participants.||participants|||Number
712071|NCT00192075|Other Pre-specified|Duration of Response - A+FOLFOX4 - Avastin Subgroup|The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.|date of first response until the first date of documented progression or death from any cause (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)|The original treatment regimens were FFG and FOLFOX. Due to FDA approval of Avastin, protocol was amended to add Avastin to treatment regimens. This is the population of patients who received Avastin with the original treatment. Results were not calculable for the A+FFG-Avastin subgroup. Two patients were censored in the A+FOLFOX4-Avastin subgroup.||months||95% Confidence Interval|Median
712072|NCT00192075|Secondary|Duration of Response|The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.|date of first response until the first date of documented progression or death from any cause (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)|Intent to treat population who were responders (had best overall response of either complete response or partial response). Zero patients in A+FFG and 2 patients in A+FOLFOX4 were censored.||months||95% Confidence Interval|Median
712073|NCT00192075|Other Pre-specified|Toxicity - Avastin Subgroup|Includes all Grade 3-4 hematologic toxicities and all non-hematologic toxicities with either >=1 Grade 4 or >=2 Grade 3 adverse events|every cycle (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)|The original treatment regimens were FFG and FOLFOX. Due to FDA approval of Avastin, protocol was amended to add Avastin to treatment regimens. This is the population of patients who received Avastin with the original treatment.||participants|||Number
712074|NCT00192075|Other Pre-specified|Survival at 12 Months and 24 Months - Avastin Subgroup|Percentage of participants who were alive at 12 months and 24 months.|randomization to the date of death from any cause (up to 24 months)|The original treatment regimens were FFG (Arm A) and FOLFOX (Arm B). Due to FDA approval of Avastin, protocol was amended to add Avastin to treatment regimens. This is the population of patients who received Avastin with the original treatment.||percentage of participants alive||95% Confidence Interval|Number
712120|NCT00183469|Primary|Mania Rating Scale|Severity of the illness and psychopathological features will be measured by the increase in the SADS Mania Rating Scale, with higher scores representing worse mania. The range of this scale is 0-75.|up to 8 months|all randomized subjects||units on a scale||Standard Error|Mean
712121|NCT00183625|Secondary|Body Mass Index|Intent was to compare medication and not work group conditions. This was initially assessed at baseline and includes total time on either risperidone or olanzapine up to 18 months.|First 18 months of study|||kg/m^2||Standard Error|Least Squares Mean
712075|NCT00192075|Other Pre-specified|Progression-Free Survival - Avastin Subgroup|Defined as the time from date of first dose to the first observation of disease progression, or death due to any cause.|randomization to the first date of progression or death from any cause (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)|The original treatment regimens were FFG and FOLFOX. Due to FDA approval of Avastin, protocol was amended to add Avastin to treatment regimens. This is the population of patients who received Avastin with the original treatment. Three patients in A+FFG - Avastin subgroup and 3 patients in A+FOLFOX4 - Avastin subgroup were censored.||months||95% Confidence Interval|Median
712076|NCT00192075|Other Pre-specified|Time to Progressive Disease - Avastin Subgroup|Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause.|randomization to the date of first documented disease progression or death due to disease under study, whichever comes first (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)|The original treatment regimens were FFG and FOLFOX. Due to FDA approval of Avastin, protocol was amended to add Avastin to treatment regimens. This is the population of patients who received Avastin with the original treatment. Three patients in A+FFG - Avastin subgroup and 4 patients in A+FOLFOX4 - Avastin subgroup were censored.||months||95% Confidence Interval|Median
712077|NCT00192075|Other Pre-specified|Tumor Response - Avastin Subgroup|Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.|baseline to measured progressive disease (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)|The original treatment regimens were FFG and FOLFOX. Due to FDA approval of Avastin, protocol was amended to add Avastin to treatment regimens. This is the population of patients who received Avastin with the original treatment.||participants|||Number
712078|NCT00192075|Secondary|Overall Survival|Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.|randomization to the date of death from any cause (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)|Intent to treat population. Eight patients in A+FFG and 12 patients in A+FOLFOX4 were censored.||months||95% Confidence Interval|Median
712079|NCT00192075|Secondary|Progression-Free Survival|Defined as the time from randomization to the first observation of disease progression, or death due to any cause.|randomization to the first date of progression or death from any cause (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)|Intent to treat population. Three patients in A+FFG and 4 patients in A+FOLFOX4 were censored.||months||95% Confidence Interval|Median
712080|NCT00192075|Secondary|Time to Progressive Disease|Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause.|randomization to the date of first documented disease progression or death due to disease under study, whichever comes first (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)|Intent to treat population. Five patients in A+FFG and 5 patients in A+FOLFOX4 were censored.||months||95% Confidence Interval|Median
712081|NCT00192075|Primary|Tumor Response by Response Evaluation Criteria In Solid Tumors (RECIST)|Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.|baseline to measured progressive disease (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)|Intent-to-Treat Population||participants|||Number
712082|NCT00183092|Secondary|Change in Semantic Verbal Fluency (Naming Animals)|Verbal fluency tests are a kind of psychological test in which participants have to say as many words as possible from a category in 60 seconds. This category (naming animals) is semantic. Higher scores indicate better cognition.|Baseline, 2 months|Subjects still alive and able to tolerate cognitive testing at month 2 visit.||number of words generated||Full Range|Mean
712083|NCT00183092|Secondary|"Change in Phonemic Fluency (Words Beginning With Letter D)"|"Verbal fluency tests are a kind of psychological test in which participants have to say as many words as possible from a category in 60 seconds. This category (words beginning with letter D) is phonemic. Higher scores indicate better cognition."|Baseline, 2 months|Subject still alive and able to tolerate cognitive testing at month 2 visit||number of words generated||Full Range|Mean
712084|NCT00183092|Secondary|ADAS-Cog Change After 2 Months Among Survivors|ADAS-cog measures cognitive performance by combining ratings of 11 components (word recall, word recognition, constructional praxis, orientation, naming objects and fingers, commands, ideational praxis, remembering instruction, spoken language, word finding, comprehension) representing six areas of cognition: memory; language; orientation to time, place and person; construction of simple designs and planning; and performing simple behaviors in pursuit of a basic, predefined goal. Seven components are scored as the ‘number incorrect’. For example, in the commands component, the number of five commands performed incorrectly (range: 0-5). Four components are scored from 0 (no limitations) to 5 (max limitations) as the examiner's perception of remembering instructions, spoken language ability, word finding and comprehension. Component scores are summed into a total ADAS-cog score ranging from 0-75, with low scores indicating better cognitive performance.|Baseline, 2 months|Subjects still alive and able to tolerate cognitive testing at Month 2 visit.||units on a scale||Full Range|Mean
712122|NCT00183625|Primary|Total Weeks Worked||24 months|Data were analyzed for work condition (IPS with or without WIPS) and not for medication (risperidone or olanzapine)||Weeks||Standard Deviation|Mean
712147|NCT00193063|Secondary|Progression Free Survival (PFS)|The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|21 Months|||months||95% Confidence Interval|Median
712085|NCT00183092|Secondary|Change in Rankin Score After 2 Months|"The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms.
- No significant disability. Able to carry out all usual activities, despite some symptoms.
- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
- Moderate disability. Requires some help, but able to walk unassisted.
- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
- Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
- Dead. For subjects unable to return for the 2-month visit, Rankin score was assessed via telephone."|Baseline, 2 months|For subjects still alive at month 2 and assessed at the 2-month visit or via telephone||units on a scale||Full Range|Mean
712086|NCT00183092|Secondary|Change in Clinical Dementia Rating Scale Sum of Boxes (CDRS-SB) After 2 Months|Clinical Dementia Rating Scale Sum of Boxes (CDRS-SB). The CDR is obtained through semistructured interviews of patients and informants, and cognitive functioning is rated in 6 domains of functioning: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. Each domain is rated on a 5-point scale of functioning: 0, no impairment; 0.5, questionable impairment; 1, mild impairment; 2, moderate impairment; and 3, severe impairment (personal care is scored on a 4-point scale without a 0.5 rating available). The global CDR score is computed via an algorithm. The CDR-SB score is obtained by summing each of the domain box scores, with scores ranging from 0 to 18. A higher value and/or positive change is worse. For subjects unable to return for month-2 visit, CDRS-SB was performed via telephone.|Baseline, 2 months|For subjects still alive at month 2 and assessed at the 2-month visit or via telephone||units on a scale||Full Range|Mean
712087|NCT00183092|Secondary|Barthel Score Change After 2 Months|An ordinal scale used to measure performance in activities of daily living. Scores range from 0 (worst, fully dependent) to 100 (best, independent); higher score associated with a greater likelihood of being able to live at home with a degree of independence following discharge from hospital. 10 individual items are scored and summed to derive the overall Barthel index score. Each item may be scored 0, 5, 10 or 15; not all items use the full range of 4 possible values. The amount of time and physical assistance required to perform each item are considered in scoring each item. For subjects unable to return for month-2 visit, Barthel Index was performed via telephone.|baseline, 2 months|One surviving subject in the quinacrine arm did not attend the 2-month visit and was lost-to-followup; for a second surviving subject in the quinacrine arm, the Barthel Index was inadvertently not performed at the 2-month visit.||units on a scale||Full Range|Mean
712088|NCT00183092|Secondary|Change in Mini–Mental State Examination (MMSE) After 2 Months|The mini–mental state examination (MMSE) is a brief 30-point questionnaire that is used to screen for cognitive impairment. In about 10 minutes it samples functions including arithmetic, memory and orientation. A score greater than or equal to 25 points (out of 30) indicates a normal cognition. Lower scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-24 points) cognitive impairment. Low to very low scores correlate closely with the presence of dementia, although other mental disorders can also lead to abnormal findings on MMSE testing.|Baseline to Month-2|Subjects still alive, who attended the month-2 visit and were willing and able to tolerate cognitive testing. 1 subject in each arm did attend the 2-month visit but did not cooperate fully with the MMSE, which was therefore not scored.||units on a scale||Full Range|Mean
712089|NCT00183092|Primary|Primary Survival|Participants alive after 2 months on study treatment|Randomization to Month-2|||participants|||Number
712090|NCT00183196|Primary|Time to Relapse to Drinking|Time to relapse drinking which is 5 standard drinks perday for males and 4 standard drinks per day for females. Subjects had a minimum of 4 days of abstinence prior to being entered into the protocol.|16 weeks|||days||Standard Error|Mean
712091|NCT00183248|Secondary|Number of Graft-versus-host Disease (GVHD) Events|A disease caused when cells from a donated stem cell graft attack the normal tissue of the transplant patient. Symptoms include jaundice, skin rash or blisters, a dry mouth, or dry eyes. Also called graft-versus-host disease.|Three years post kidney transplant|Intent-to-Treat||GVHD Events|||Number
712092|NCT00183248|Secondary|Number of Chronic Allograft Nephropathies|"Number of chronic allograft nephropathies[1,2,3] at 3 years post kidney transplant.
Chronic allograft nephropathy is defined as renal biopsies with Banff 97 Grade I or greater[2] with higher numeric scores indicating more severe nephropathy
The Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification[3]
Reference: Racusen LC, Solez K, Colvin RB et al. The Banff 97 working classification of renal allograft pathology. Kidney Int, 55: 713-723, 1999"|Three years post kidney transplant|Participants who experienced nephropathies||Nephropathy Events|||Number
712093|NCT00183248|Secondary|Number of Kidney Biopsy-proven Acute Rejection|"Biopsy-proven acute renal (kidney) rejection[1,2].
Diagnosis of acute rejection was made by renal biopsy using the Banff 97 criteria. The Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Acute rejection is defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection[2]
Ref: Racusen LC et al. The Banff 97 working classification of renal allograft pathology. Kidney Int, 55: 713-723, 1999"|Three years post kidney transplant|Participants who experienced an acute rejection||Rejection Events|||Number
712094|NCT00183248|Secondary|Graft Survival at Three Years Post-Transplant|"Number of participants that did not experience kidney graft failure[1] at three years post-transplant
[1]Graft failure is defined as the institution of chronic dialysis (at least 6 consecutive weeks, excluding participants with delayed graft function), transplant nephrectomy, or retransplantation."|Three years post kidney transplant|Intent-to-Treat||participants|||Number
712095|NCT00183248|Secondary|Participant Survival at Three Years Post Kidney Transplant||Three years post kidney transplant|Intent-to-Treat||participants|||Number
712096|NCT00183248|Primary|Overall Kidney Graft Survival at One Year Post-Transplant|"Number of participants that did not experience kidney graft failure[1] at one year post-transplant
[1]Graft failure is defined as the institution of chronic dialysis (at least 6 consecutive weeks, excluding participants with delayed graft function), transplant nephrectomy, or retransplantation."|One year post kidney transplant|Intent-to-treat||participants|||Number
712097|NCT00183248|Primary|Overall Participant Survival at One Year Post Kidney Transplant||One year post kidney transplant|Intent-to-Treat||participants|||Number
712145|NCT00193050|Primary|Pathologic Complete Response (pCR)||18 Months|||percentage of participants||95% Confidence Interval|Number
712098|NCT00183274|Secondary|Clinical Global Impressions, Severity of Illness|"The CGI provides an overall clinician-determined summary measure that takes into account a knowledge of the patient's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the patient's ability to function.
The CGI is rated on the following seven-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients.
Results of the Placebo After Placebo group in Phase 3 were not entered due to sample size limitations."|Measured at Months 6 (Open Label), 12 (Double-Blind), 18 (Double-Blind, and 24 (Double-Blind Relapse)|The primary efficacy analytic method was time to relapse analyses estimated using a discrete time Cox proportional hazards model.Chisquare analyses were used to contrast relapse or responder rates. In the case of small cell sizes, Fisher exact test replaced chisquare analysis.||Severity Score||Standard Deviation|Mean
712099|NCT00183274|Primary|Hamilton Rating Scale for Anxiety|"Hamilton Rating Scale for Anxiety - The assessment of anxiety states by rating
Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0–56, where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe."|Measured at Months 6 (Open Label), 12 (Double-Blind), and 18 (Double-Blind Relapse)|The primary efficacy analytic method was time-to-relapse analyses estimated using a discrete-time Cox proportional hazards model.||HAM-A Rating Score||Standard Deviation|Mean
712100|NCT00183339|Secondary|Change From Baseline to Month 12 in Aberrant Behavior Checklist Irritability Subscale Score (ABC-I)|The Aberrant Behavior Checklist (ABC) is a caregiver completed rating scale that assesses problem behaviors frequently seen in individuals with developmental disabilities. There are a total of 58 items on 5 subscales that are rated from 0 - not at all a problem to 3 - problem is severe in degree. The ABC-I consists of 15 items that reflect mood swings, self-injury and aggression. The subscale score is the sum of the score on each of the 15 items. The minimum score on the ABC-I is 0 and the maximum score is 45. Higher scores reflect more severe behavioral problems. A score > or = to 18 is generally considered clinically significant.|12 months|||units on a scale||Standard Deviation|Mean
712101|NCT00183339|Secondary|Change From Baseline to 12 Months in Total Score on Caregiver Strain Questionnaire|This is a caregiver completed measure that assesses the extent to which the caregiver feels care of the participant influences the caregiver's and other family members' emotional states and/or activities. There are a total of 22 items rated from 1 - not at all to 5 - very much (with one item reverse scored). Total score is the sum of all the items (with one item reverse scored). There are three subscales objective strain -12 items, internalized subjective strain 6 items, externalized subjective 4 items. The total score can range from a minimum of 0 - no strain at all, to 110 all items rated as very much.|12 months|||units on a scale||Standard Deviation|Mean
712102|NCT00183339|Secondary|Rate of Attrition|The percentage of participants who discontinued treatment prior to completion of the 12 month study|Measured at Month 12|||percent of group that discontinued early|||Number
712103|NCT00183339|Primary|Rate of Recruitment|In order for a larger trial with similar design to be feasible a number of factors needed to be examined. The first was whether families would enroll very young children with ASD into a year long blinded medication study. To determine this we examined the average number of months to randomize 1 participant per site. We calculated this (as total # months required for recruitment* 2sites ) /[ # participants randomized ] and compared it to the typical # of months required to recruit an older child with ASD for a double-blind 12 week placebo controlled medication study, which is typically about 1.2 months at each of the sites involved in the study.|19 months|||months/participant at 1 site|||Number
712104|NCT00183430|Secondary|Measures of Nightmare Frequency, Depressive Signs and Symptoms, Quality of Life, and Number of Study Days Completed||Measured at Weeks 4 and 8 post-treatment||||||
712105|NCT00183430|Secondary|"CAPS Subscale Scores (Reexperiencing/Intrusions, Avoidance/Numbing, and Hyperarousal)"||Measured at Weeks 4 and 8 post-treatment||||||
712106|NCT00183430|Secondary|Total CAPS Score||Measured at Weeks 4 and 8 post-treatment||||||
712107|NCT00183430|Primary|Change in Sleep Assessed by the Pittsburgh Sleep Quality Index|Pittsburgh Sleep Quality Index is a self-report questionnaire assessing sleep quality and disturbances over a 1-month time interval. A global score is obtained by summing the seven component subscales (total score range: 0-21). A score of 5 or less indicates good sleep quality. A score of more than 5 indicates poor sleep quality. Change is measured from Baseline to Week 8.|Baseline to Week 8|Number of participants analyzed equals the number of participants who were able to complete this assessment at Week 8.||Units on a Scale||Standard Deviation|Mean
712108|NCT00183430|Primary|Change in Recurring Distressing Dreams and Difficulty Falling and Staying Asleep Items of the CAPS|"Item B-2 recurrent distressing dreams of the event is a single item from teh Clinician Administered PTSD Scale (CAPS). The rating consists of two parts: Frequency plus Intensity. Symptom frequency rated 0 to 4. Symptom intensity rated 0 to 4. Frequency plus Intensity ratings equal the total score. The total minimum score = zero. The total maximum score = 8. A higher score is worse; a lower score is better. This outcome measure evaluates the change in score from Baseline to Week 8."|Baseline to Week 8|Number of participants analyzed equals the number of participants who were able to complete this assessment at Week 4.||Units on a Scale||Standard Deviation|Mean
712109|NCT00183430|Primary|Clinical Global Impression of Change|The Clinical Global Impression of Change is a 7-point scale that rates global change compared to baseline (1=markedly improved, 2=moderately improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=moderately worse, 7=markedly worse). The Clinical Global Impression of Change is used to determine the impact of treatment effects on meaningful and distinct change in overall sense of well-being and functioning. This outcome measure evaluates change from Baseline to Week 8.|Baseline to Week 8|Number of participants analyzed equals the number of participants who were able to complete this assessment at Week 8.||Units on a Scale||Standard Deviation|Mean
712110|NCT00183456|Secondary|HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)||18 months|||participants|||Number
712111|NCT00183456|Primary|Sex Risk Behaviors: Any High Risk Sexual Behavior (Past 90 Days)||18 months|||participants|||Number
712112|NCT00183456|Primary|Sex Risk Behaviors: Unprotected Sex With a Non-main Partner (Past 90 Days)||18 months|||participants|||Number
712113|NCT00183456|Primary|Sex Risk Behaviors: Unprotected Sex With Main Partner (Past 90 Days)||18 months|||participants|||Number
712114|NCT00183456|Primary|Sex Risk Behaviors: Unprotected Vaginal Sex (Past 90 Days)||18 months|||participants|||Number
712123|NCT00183677|Primary|Responder and Remission Status (%), Based on the Depression Rating Scale Score|The Hamilton Depression Rating Scale, 17 items (HAMD-17, range 0-52) was used to measure changes in depression severity from baseline to endpoint. Clinical Responder status was defined as > 50% improvement (i.e., reduction) in HAMD-17 score from baseline to endpoint. Clinical Remission status was defined as HAMD-17 score < 8 at endpoint (week 12 visit).|Measured at Week 12|97 patients with MDD (42 Female) enrolled in the 12 week study, 53 patients (27 Female) completed. Only completers were included in the primary outcome measure.||participants|||Number
712124|NCT00183729|Secondary|Functional Recovery||Measured at Week 12||||||
712125|NCT00183729|Secondary|Incidence of Major Depressive Disorder||Measured at Week 12||||||
712126|NCT00183729|Primary|Depressive Symptoms|Hamilton depression rating scale ; scale ranges 0 (no symptoms) to 52 (severe depression)|Measured at Week 12|||units on a scale||Standard Deviation|Mean
712127|NCT00183794|Secondary|Median Time to Progression (Months)|Defined as the time from first day of treatment to the first observation of disease progression or death due to any cause. If a patient has not progressed or died, progression-free survival is censored at the time of last follow-up. Progression based on RECIST v1.0 criteria for measurable disease, and on CA-125 for patients with an elevated CA-125 as the only evidence of disease (Rustin et al. JCO 14:1545-51, 1996)|6 months after enrollment of last patient|All participants who receive the first course of treatment are included in the summary of PFS.||Months||Full Range|Median
712128|NCT00183794|Primary|Tumor Response Type: CR, PR, SD or PD|Tumor response will be based on the RECIST v1.0 criteria. CR (complete response)= disappearance of all target lesions, PR (partial response)= greater or equal to 30% decrease in sum of longest diameter of target lesions, SD (stable disease)= <30% decrease or <20% increase, PD (progressive disease)= greater or equal to 20% increase in longest diameter of target lesions. For patients with an elevated CA-125 as the only evidence of disease, a PR was defined as a decrease of 50% or more lasting at least 8 weeks (Rustin et al. JCO 14:1545-51, 1996). Disease assessment performed every 2 cycles (1 cycle = 21 days). Responders included CR and PR.|6 months after enrollment of last participant|Participants with evaluable or measurable tumor, who complete 2 courses of treatment will be included in analysis of tumor response.||Participants|||Number
712129|NCT00192296|Secondary|Terminal Phase Elimination Rate (Vz)|Vz of MEDI-528|Days 0, 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84|All subjects who received MEDI-528||Liters||Geometric Coefficient of Variation|Geometric Mean
712130|NCT00192296|Secondary|Half-life (T1/2)|T1/2 of MEDI-528|Days 0, 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84|All subjects who received MEDI-528||Hours||Geometric Coefficient of Variation|Geometric Mean
712131|NCT00192296|Secondary|Total Body Clearance (CL)|CL of MEDI-528|Days 0, 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84|All subjects who received MEDI-528||Milliter per day||Geometric Coefficient of Variation|Geometric Mean
712132|NCT00192296|Secondary|Percent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)]|AUC(ext) of MEDI-528|Days 0 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84|All subjects who received MEDI-528||Percentage of Projected AUC||Geometric Coefficient of Variation|Geometric Mean
712133|NCT00192296|Secondary|Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)]|AUC(0-infinity) of MEDI-528|Days 0 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84|All subjects who received MEDI-528||Microgram times hours per milliliter||Geometric Coefficient of Variation|Geometric Mean
712134|NCT00192296|Secondary|Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)]|AUC(0-t) of MEDI-528|Days 0 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84|All subjects who received MEDI-528||Micrograms times hours per milliliter||Geometric Coefficient of Variation|Geometric Mean
712135|NCT00192296|Secondary|Observed Maximum Serum Concentration (Cmax)|Cmax of MEDI-528|Days 0 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84|All subjects who received MEDI-528||Micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
712136|NCT00192296|Secondary|Time to Observed Maximum Serum Concentration (Tmax)|Tmax of MEDI-528|Days 0 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84|All subjects who received MEDI-528||Hours||Full Range|Median
712137|NCT00192296|Secondary|Incidence of Anti-drug Antibodies (ADA) to MEDI-528|Number of participants who had ADA detected at each time point|Days 14, 28, 42, and 84|All subjects who received MEDI-528||Participants|||Number
712138|NCT00192296|Primary|Incidence of Serious Adverse Events|Number of participants experiencing serious adverse events|Days 0 - 84|All subjects who received MEDI-528||Participants|||Number
712139|NCT00192296|Primary|Incidence of Abnormal Troponin Levels|Number of participants with troponin levels greater than upper limit of normal (> 0.05 ng/mL)|Days 0, 7, 14, 21, and 28|All subjects who received MEDI-528||Participants|||Number
712140|NCT00192296|Primary|Incidence of Adverse Events|Number of participants experiencing adverse events (includes both adverse events and serious adverse events)|Days 0 - 84|All subjects who received MEDI-528||Participants|||Number
712141|NCT00193037|Secondary|Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease.|PFS was defined as the interval from first study treatment until the date that the first progression of breast cancer was documented, or death occurred.|18 Months|||months||95% Confidence Interval|Median
712142|NCT00193037|Primary|Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment|ORR is defined as the percentage of patients who exhibit a Complete Response (CR) or Partial Response (PR). Complete Response is the total disappearance of clinically and radiologically detectable disease for at least 4 weeks. Partial Response is at least a 50% reduction of all measurable lesions as measured by the product of the perpendicular diameters of the greatest dimensions of tumor size, with no new lesions appearing for at least four weeks.|18 Months|Patients who were removed from treatment before evaluation were not included in analysis||percentage of patients||95% Confidence Interval|Number
712143|NCT00193050|Secondary|Overall Survival (OS)||48 months||||||
712144|NCT00193050|Secondary|Time to Treatment Failure (TTF)||69 months||||||
712148|NCT00193063|Primary|Overall Response Rate (ORR)|The Percentage of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|18 Months|||percentage of participants||95% Confidence Interval|Number
712149|NCT00193128|Secondary|Overall Survival (OS)|Length of time, in months, that patients were alive from their first date of protocol treatment until death.|36 months||||||
712150|NCT00193128|Secondary|Disease-Free Survival (DFS)|Defined as the interval between the start date of treatment and the date of occurrence of progressive disease or death from any cause.|18 months||||||
712151|NCT00193128|Primary|Pathologic Complete Response Rate (PCRR), the Percentage of Patients Who Have No Evidence of Cancer in Their Surgical Specimen Following Surgery|The absence of any residual tumor cells in a histologic evaluation of a tumor specimen is defined as a complete pathologic response|18 months|Analysis was conducted on the 49 patients in Cohort 2 who received triplet chemotherapy||percentage of participants|||Number
712152|NCT00193180|Secondary|Overall Survival (OS)|Defined as the time from first protocol treatment to date of death due to any cause.|18 months|||months||95% Confidence Interval|Median
712153|NCT00193180|Secondary|Progression Free Survival (PFS)|PFS defined as the length of time, in months, that patients were alive from date of first protocol treatment until worsening of disease, assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.|18 months|||Months||95% Confidence Interval|Median
712154|NCT00193180|Primary|Overall Response Rate (ORR)|Defined as the proportion of patients with confirmed complete or partial response (CR or PR), recorded from date of treatment until date of recurrence or progressive disease, and assessed by RECIST v 1.1.|18 months|||percentage of participants||95% Confidence Interval|Number
712155|NCT00193206|Secondary|Rates of Breast Preservation||18 months||||||
712156|NCT00193206|Secondary|Time to Disease Progression||18 months||||||
712157|NCT00193206|Secondary|Clinical Response Rates||18 months||||||
712158|NCT00193206|Primary|Pathologic Complete Response||18 months|||participants|||Number
712159|NCT00193219|Secondary|Safety of FOLFOX6 Combined With Bevacizumab and Cetuximab||18 months||||||
712160|NCT00193219|Secondary|Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death|Measured from the date of first treatment until the date of death from any cause|36 months|This study was originally designed as a randomized study with patients receiving FOLFOX and bevacizumab with or without cetuximab. Following an amendment, all patients received cetuximab, FOLFOX and bevacizumab. The 5 patients randomized prior to the amendment that did not receive cetuximab are excluded from the analysis.||months||95% Confidence Interval|Median
712161|NCT00193219|Secondary|Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease|Defined as the interval between the start date of treatment and the date of occurrence of progressive disease or death.|18 months|This study was originally designed as a randomized study with patients receiving FOLFOX and bevacizumab with or without cetuximab. Following an amendment, all patients received cetuximab, FOLFOX and bevacizumab. The 5 patients randomized prior to the amendment that did not receive cetuximab are excluded from the analysis.||months||95% Confidence Interval|Median
712162|NCT00193219|Primary|Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|18 months|This study was originally designed as a randomized study with patients receiving FOLFOX and bevacizumab with or without cetuximab. Following an amendment, all patients received cetuximab, FOLFOX and bevacizumab. The 5 patients randomized prior to the amendment that did not receive cetuximab are excluded from the analysis.||percentage of patients||95% Confidence Interval|Number
712163|NCT00193258|Primary|Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death||24 months|All patients enrolled in the study||months||95% Confidence Interval|Median
712164|NCT00193258|Primary|Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease||18 months|All patients enrolled in the trial||months||95% Confidence Interval|Median
712165|NCT00193258|Primary|Objective Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|18 months|Eighty-seven of 94 patients (93%) received ≥ 2 months of treatment and were fully evaluable for response. Seven patients discontinued treatment during the first 8 weeks. One of these 7 patients had evidence of rapid tumor progression, whereas the remaining 6 patients discontinued treatment because of toxicity or for personal reasons.||percentage of participants||95% Confidence Interval|Number
712166|NCT00193375|Primary|Number of Grade 3/4 Toxicities Patients Experienced on Maintenance Bevacizumab Following Chemoradiation for Limited Stage - Small Cell Lung Cancer (LS-SCLC)|Toxicity was evaluated in all patients who received at least 1 dose of therapy, and graded according to CTCAE v. 3.|18 months|Patients who received at least one dose of bevacizumab maintenance therapy were assessed for toxicities.||Grade 3/4 Toxicity Events|||Number
712167|NCT00193375|Secondary|Overall Response Rate|Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters.|18 month|All patients were evaluated for response by RECIST v. 1 criteria. All patients with major responses had confirmation of response on repeat scans by the same technique(s) 4 weeks (or longer) later.||percentage of participants||95% Confidence Interval|Number
712201|NCT00194025|Secondary|Tolerability as Measured by Mean Serum Level at Study Endpoint||Baseline to 12 weeks|Last Observation Carried Forward (LOCF) was used as the imputation technique.||ug/mL||Standard Deviation|Mean
712168|NCT00193375|Secondary|2-Year Progression-free Survival (PFS)|Progression-free survival (PFS) was defined as the date of study entry until the date of tumor progression or death. 2-Year PFS is the percentage of patients alive and without progressive disease (PD) 2 years from the date of study entry.|24 months|All patients were assessed for progression free survival.||percentage of participants|||Number
712169|NCT00193414|Secondary|Overall Survival (OS)|OS was measured from the date of study entry until the date of death.|18 months|All patients were assessed for OS.||Months||95% Confidence Interval|Median
712170|NCT00193414|Secondary|Progression-free Survival (PFS)|PFS was defined as the interval between the start date of treatment and the date of occurrence of progressive disease or death from any cause.|18 months|All patients were assessed for PFS.||Months||95% Confidence Interval|Median
712171|NCT00193414|Primary|Overall Response Rate|Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters.|18 months|All patients were assessed for response.||Percentage of participants with CR/PR||95% Confidence Interval|Number
712172|NCT00193427|Secondary|Overall Survival (OS)|Overall survival was calculated as the elapsed time bewteen date of study registration and the date of death.|18 months|All patients were assessed for overall survival after a median follow-up of 19 months.||Months||95% Confidence Interval|Median
712173|NCT00193427|Secondary|Overall Response Rate (ORR)|Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters.|18 months|Patients who were assessable after completion of 9 weeks of treatment were evaluated and assigned a response category.||Percent of patients with CR or PR|||Number
712174|NCT00193427|Secondary|Progression Free Survival (PFS)|Progression-free survival was calculated as the elapsed time between the date of study registration and the date of recurrence or death from any cause.|19 months|All patients were assessed for progression free survival after a median follow up of 19 months.||Months||95% Confidence Interval|Median
712175|NCT00193427|Primary|Pathologic Complete Response Rate|A pathological complete response (pCR) was defined as having no residual cancer at the primary site or in regional lymph nodes on pathologic review.|18 months|All patients who underwent a thoracotomy were assigned a pathologic response category.||Percent of participants with pCR|||Number
712176|NCT00193453|Secondary|Response Duration|The Response Duration was calculated from time of initial measured response to date of first observation of progressive disease.|18 months|Patients with at least one restaging were assessed for overall clinical response. Patients who died prior to the first restaging or were not assessed due to physician/patient discretion were not included in the analysis.||Months||95% Confidence Interval|Median
712177|NCT00193453|Secondary|Progression Free Survival (PFS)|Progression free survival was defined as the interval between the start date of treatment and the date of occurrence of progressive disase or death from any cause.|18 months|All patients were assessed for progression-free survival.||Months||95% Confidence Interval|Median
712178|NCT00193453|Primary|Overall Clinical Response Rate|Overall response rate was defined as the proportion of treated patients whose best response was a complete or partial response after completing at least two courses of treatment.|18 months|Patients with at least one restaging were assessed for overall clinical response. Patients who died prior to the first restaging or were not assessed due to physician/patient discretion were not included in the analysis.||Percentage of participants||95% Confidence Interval|Number
712179|NCT00193479|Primary|Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|18 Months|||percentage of patients|||Number
712180|NCT00193492|Secondary|Progression Free Survival (PFS)|The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death or Disease Progression from NHL. Progression is defined using International Workshop Response Criteria for Non-Hodgkin’s Lymphoma as - enlargment of liver/spleen, new sites, new or increased malignancy in lymph nodes, new or increased lymph node masses or reappearance of disease in bone marrow.|18 months|||months||95% Confidence Interval|Median
712181|NCT00193492|Primary|Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|18 months|||percentage of participants||95% Confidence Interval|Number
712182|NCT00193596|Secondary|Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease|Length of time, in months, that patients were alive from their first date of protocol treatment until worsening of their disease|12 months|||months||95% Confidence Interval|Median
712183|NCT00193596|Primary|Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death|Length of time, in months, that patients were alive from their first date of protocol treatment until death.|24 months|||months||95% Confidence Interval|Median
712184|NCT00193609|Secondary|Overall Survival|Length of time, in months, that patients were alive from their first date of protocol treatment until death.|18 months|||months||95% Confidence Interval|Median
712185|NCT00193609|Primary|Progression Free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|18 months|||months||95% Confidence Interval|Median
712202|NCT00194025|Secondary|Tolerability as Assessed by Weight Change||Baseline to 12 weeks|All available data was used implementing LOCF.||kilograms||Standard Deviation|Mean
712186|NCT00194012|Secondary|Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale IV or (ARS-IV)|The Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale IV or (ARS-IV) is a clinician-scored rating scale used to track the frequency of ADHD symptoms during the previous 1-week period. The ARS-IV contains 18 questions--(9 focused on inattention, and 9 on hyperactivity-impulsivity.) Questions are answered in a way that best describes ADHD symptom frequency--Never or Rarely=0, Sometimes=1, Often=2, or Very Often=3. The clinician adds up the responses for a total score. Higher total scores indicate a greater degree of symptoms being present. As a result, the minimum score is 0, and the maximum score is 54.|Open-Label Extension - 6 weeks|22 patients in the Open-Label Extension (from initial Abilify) group and 21 patients in the Open-Label Extension (from initial placebo) group completed at least 1 week of the open-label extension (see participant flow). Due to missing data, data on 20 of those 22 and 17 of those 21 completed the ARS-IV and were available and included the analysis.||Scores on a scale||Standard Deviation|Mean
712187|NCT00194012|Secondary|Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale IV or (ARS-IV)|The Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale IV or (ARS-IV) is a clinician-scored rating scale used to track the frequency of ADHD symptoms during the previous 1-week period. The ARS-IV contains 18 questions--(9 focused on inattention, and 9 on hyperactivity-impulsivity.) Questions are answered in a way that best describes ADHD symptom frequency--Never or Rarely=0, Sometimes=1, Often=2, or Very Often=3. The clinician adds up the responses for a total score. Higher total scores indicate a greater degree of symptoms being present. As a result, the minimum score is 0, and the maximum score is 54.|12 weeks|There were 30 patients in the Abilify group and 29 patients in the placebo group who completed at least 1 week of the study as per the participant flow. As a result of missing data, data on 28 of 30 in the Abilify group and 28 of 29 in the placebo group were available and included in the analysis.||units on a scale||Standard Deviation|Mean
712188|NCT00194012|Secondary|Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale IV or (ARS-IV)|The Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale IV or (ARS-IV) is a clinician-scored rating scale used to track the frequency of ADHD symptoms during the previous 1-week period. The ARS-IV contains 18 questions--(9 focused on inattention, and 9 on hyperactivity-impulsivity.) Questions are answered in a way that best describes ADHD symptom frequency--Never or Rarely=0, Sometimes=1, Often=2, or Very Often=3. The clinician adds up the responses for a total score. Higher total scores indicate a greater degree of symptoms being present. As a result, the minimum score is 0, and the maximum score is 54.|Baseline|There were 30 patients in the Abilify group and 29 patients in the placebo group who completed at least 1 week of the study as per the participant flow. As a result of missing data, data on 28 of 30 in the Abilify group and 28 of 29 in the placebo group were available and included in the analysis.||units on a scale||Standard Deviation|Mean
712189|NCT00194012|Secondary|Clinical Global Impressions Scale (CGI-Severity)|Clinical Global Impressions Scale (CGI-Severity) is a physician-administered assessment designed to track progress over time on a wide range of psychiatric disorders. The CGI-Severity or CGI-S consists of one question about the extent of a patient's mental illness at the time of the assessment. Using a 7-point rating scale, clinicians rate the severity of mental illness based on an average of observed and reported symptoms, behavior and function during the past 7 days. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Open-Label Extension - 6 weeks|22 patients in the Open-Label Extension (from initial Abilify) group and 21 patients in the Open-Label Extension (from initial placebo) group completed at least 1 week of the open-label extension (see participant flow). Due to missing data, data on 20 of those 22 and 18 of those 21 completed the CGI-S and were available and included the analysis.||Scores on a scale||Standard Deviation|Mean
712190|NCT00194012|Secondary|Clinical Global Impressions Scale (CGI-Severity)|Clinical Global Impressions Scale (CGI-Severity) is a physician-administered assessment designed to track progress over time on a wide range of psychiatric disorders. The CGI-Severity or CGI-S consists of one question about the extent of a patient's mental illness at the time of the assessment. Using a 7-point rating scale, clinicians rate the severity of mental illness based on an average of observed and reported symptoms, behavior and function during the past 7 days. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|12 weeks|There were 30 patients in the Abilify group and 29 patients in the placebo group who completed at least 1 week of the study as per the participant flow. As a result of missing data, data on 28 of 30 in the Abilify group and 28 of 29 in the placebo group were available and included in the analysis.||units on a scale||Standard Deviation|Mean
712191|NCT00194012|Secondary|Clinical Global Impressions Scale (CGI-Severity)|Clinical Global Impressions Scale (CGI-Severity) is a physician-administered assessment designed to track progress over time on a wide range of psychiatric disorders. The CGI-Severity or CGI-S consists of one question about the extent of a patient's mental illness at the time of the assessment. Using a 7-point rating scale, clinicians rate the severity of mental illness based on an average of observed and reported symptoms, behavior and function during the past 7 days. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Baseline|There were 30 patients in the Abilify group and 29 patients in the placebo group who completed at least 1 week of the study as per the participant flow. As a result of missing data, data on 28 of 30 in the Abilify group and 28 of 29 in the placebo group were available and included in the analysis.||units on a scale||Standard Deviation|Mean
712192|NCT00194012|Secondary|Children's Global Assessment Scale (CGAS)|"Children's Global Assessment Scale (CGAS) is a scale that clinicians use in order to rate the general emotional and behavioral functioning of children and adolescents under age 18. The scoring range is either 1 to 100. Youth with higher scores indicate better functioning with 91-100 Doing very well to 1-10 Extremely impaired.
The score should be calculated separate from diagnosis, treatment or prognosis."|Open-Label Extension - 6 weeks|22 patients in the Open-Label Extension (from initial Abilify) group and 21 patients in the Open-Label Extension (from initial placebo) group completed at least 1 week of the open-label extension (see participant flow). Due to missing data, data on 19 of those 22 and 18 of those 21 completed the CGAS and were available and included the analysis.||Scores on a scale||Standard Deviation|Mean
712203|NCT00194025|Secondary|Change in Extrapyramidal Symptoms as Assessed by the Simpson Angus Neurological Rating Scale (SAS)|The best and worst possible overall scores are 40 and 0 units on a scale, respectively.|Baseline to 12 weeks|Last Observation Carried Forward (LOCF) was used as the imputation technique.||scores on a scale||Standard Deviation|Mean
712193|NCT00194012|Secondary|Children's Global Assessment Scale (CGAS)|"Children's Global Assessment Scale (CGAS) is a scale that clinicians use in order to rate the general emotional and behavioral functioning of children and adolescents under age 18. The scoring range is either 1 to 100. Youth with higher scores indicate better functioning with 91-100 Doing very well to 1-10 Extremely impaired.
The score should be calculated separate from diagnosis, treatment or prognosis."|12 weeks|There were 30 patients in the Abilify group and 29 patients in the placebo group who completed at least 1 week of the study as per the participant flow. As a result of missing data, data on 28 of 30 in the Abilify group and 28 of 29 in the placebo group were available and included in the analysis.||Scores on a scale||Standard Deviation|Mean
712194|NCT00194012|Secondary|Children's Global Assessment Scale (CGAS)|"Children's Global Assessment Scale (CGAS) is a scale that clinicians use in order to rate the general emotional and behavioral functioning of children and adolescents under age 18. The scoring range is either 1 to 100. Youth with higher scores indicate better functioning with 91-100 Doing very well to 1-10 Extremely impaired.
The score should be calculated separate from diagnosis, treatment or prognosis."|Baseline|There were 30 patients in the Abilify group and 29 patients in the placebo group who completed at least 1 week of the study as per the participant flow. As a result of missing data, data on 28 of 30 in the Abilify group and 28 of 29 in the placebo group were available and included in the analysis.||Scores on a scale||Standard Deviation|Mean
712195|NCT00194012|Secondary|CDRS-R Children's Depression Rating Scale-Revised|The CDRS-R is a rating scale used to assess severity of depression and change in depressive symptoms in children and adolescents. The CDRS-R is a 17-item scale administered by clinician's in interviews with a child/parent(s). Each item is scored on a range of 1-5 or 1-7 with a total possible score of 17-113. A score greater or equal to 40 is indicative of depression and a score less than or equal to 28 is typically means few or no depressive symptoms.|Open-Label Extension - 6 weeks|22 patients in the Open-Label Extension (from initial Abilify) group and 21 patients in the Open-Label Extension (from initial placebo) group completed at least 1 week of the open-label extension (see participant flow). Due to missing data, data on 20 of those 22 and 18 of those 21 completed the CDRS-R and were available and included the analysis.||Scores on a scale||Standard Deviation|Mean
712196|NCT00194012|Secondary|CDRS-R Children's Depression Rating Scale-Revised|The CDRS-R is a rating scale used to assess severity of depression and change in depressive symptoms in children and adolescents. The CDRS-R is a 17-item scale administered by clinician's in interviews with a child/parent(s). Each item is scored on a range of 1-5 or 1-7 with a total possible score of 17-113. A score greater or equal to 40 is indicative of depression and a score less than or equal to 28 is typically means few or no depressive symptoms.|12 weeks|There were 30 patients in the Abilify group and 29 patients in the placebo group who completed at least 1 week of the study as per the participant flow. As a result of missing data, data on 28 of 30 in the Abilify group and 28 of 29 in the placebo group were available and included in the analysis.||Scores on a scale||Standard Deviation|Mean
712197|NCT00194012|Secondary|Children's Depression Rating Scale-Revised (CDRS-R )|The CDRS-R is a rating scale used to assess severity of depression and change in depressive symptoms in children and adolescents. The CDRS-R is a 17-item scale administered by clinician's in interviews with a child/parent(s). Each item is scored on a range of 1-5 or 1-7 with a total possible score of 17-113. A score greater or equal to 40 is indicative of depression and a score less than or equal to 28 is typically means few or no depressive symptoms.|Baseline|There were 30 patients in the Abilify group and 29 patients in the placebo group who completed at least 1 week of the study as per the participant flow. As a result of missing data, data on 28 of 30 in the Abilify group and 28 of 29 in the placebo group were available and included in the analysis.||Scores on a scale||Standard Deviation|Mean
712198|NCT00194012|Primary|Young Mania Rating Scale (YMRS)|The Young Mania Rating Scale (YMRS) has 11 items and is based on the patient’s subjective report of his or her clinical condition over the previous 48 hours. Additional information is based upon clinical observations made during the course of the clinical interview. The items are selected based upon published descriptions of the core symptoms of mania. Each item o the YMRS is given a severity rating. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. These four items are given twice the weight of the others to compensate for poor cooperation from severely ill patients. There are well described anchor points for each grade of severity. Total score ranges from 0 to 60, with higher being more severe mania.|Open-Label Extension - 6 weeks|22 patients in the Open-Label Extension (from initial Abilify) group and 21 patients in the Open-Label Extension (from initial placebo) group completed at least 1 week of the open-label extension (see participant flow). Due to missing data, data on 20 of those 22 and 18 of those 21 completed the YMRS and were available and included the analysis.||Scores on a scale||Standard Deviation|Mean
712199|NCT00194012|Primary|Young Mania Rating Scale (YMRS)|The Young Mania Rating Scale (YMRS) has 11 items and is based on the patient’s subjective report of his or her clinical condition over the previous 48 hours. Additional information is based upon clinical observations made during the course of the clinical interview. The items are selected based upon published descriptions of the core symptoms of mania. Each item o the YMRS is given a severity rating. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. These four items are given twice the weight of the others to compensate for poor cooperation from severely ill patients. There are well described anchor points for each grade of severity. Total score ranges from 0 to 60, with higher being more severe mania.|12 weeks|||Scores on a scale||Standard Deviation|Mean
712200|NCT00194012|Primary|Young Mania Rating Scale (YMRS)|The Young Mania Rating Scale (YMRS) has 11 items and is based on the patient’s subjective report of his or her clinical condition over the previous 48 hours. Additional information is based upon clinical observations made during the course of the clinical interview. The items are selected based upon published descriptions of the core symptoms of mania. Each item o the YMRS is given a severity rating. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. These four items are given twice the weight of the others to compensate for poor cooperation from severely ill patients. There are well described anchor points for each grade of severity. Total score ranges from 0 to 60, with higher being more severe mania.|Baseline|||Scores on a scale||Standard Deviation|Mean
712204|NCT00194025|Secondary|Change in Extrapyramidal Symptoms as Assessed by the Abnormal Involuntary Movement Scale (AIMS)|The best and worst possible overall scores are 0 and 28 units on a scale, respectively.|Baseline to 12 weeks|Last Observation Carried Forward (LOCF) was used as the imputation technique.||scores on a scale||Standard Deviation|Mean
712205|NCT00194025|Secondary|Change in Physical Health Status as Measure by the Physical Composite Score (PCS) Subscale of the Short Form 36 Health Survey (SF-36)|The best and worst possible PCS scores are 100 and 0 units on a scale, respectively.|Baseline to 12 weeks|Last Observation Carried Forward (LOCF) was used as the imputation technique.||scores on a scale||Standard Deviation|Mean
712206|NCT00194025|Secondary|Change in Overall Mental Health Status as Measure by the Mental Composite Score (MCS) Subscale of the Short Form 36 Health Survey (SF-36)|The best and worst possible MCS scores are 100 and 1 units on a scale, respectively.|Baseline to 12 weeks|The number of participants for analysis was based on available data. Last Observation Carried Forward (LOCF) was used as the imputation technique.||scores on a scale||Standard Deviation|Mean
712207|NCT00194025|Secondary|Change in Depression Symptoms as Measured by the Geriatric Depression Scale (GDS)|The best and worst possible GDS scores are 0 and 30 units on a scale, respectively.|Baseline to 12 weeks|Last Observation Carried Forward (LOCF) was used as the imputation technique.||scores on a scale||Standard Deviation|Mean
712208|NCT00194025|Secondary|Change in Overall Functioning as Measured by the Global Assessment Scale (GAS)|The best and worst possible GAS scores are 100 and 1 units on a scale, respectively.|Baseline to 12 weeks|Last Observation Carried Forward (LOCF) was used as the imputation technique.||scores on a scale||Standard Deviation|Mean
712209|NCT00194025|Secondary|Change in Cognitive Status as Measured by the Mini-mental State Examination (MMSE)|The best and worst possible overall scores are 31 and 0 units on a scale, respectively.|Baseline to 12 weeks|Last Observation Carried Forward (LOCF) was used as the imputation technique.||scores on a scale||Standard Deviation|Mean
712210|NCT00194025|Primary|Change in Schizophrenia Psychopathology as Assessed by the Positive and Negative Symptom Scale (PANSS)|The best and worst possible overall PANSS scores are 30 and 210 units on a scale, respectively.|Baseline to 12 weeks|Last Observation Carried Forward (LOCF) was used as the imputation technique.||scores on a scale||Standard Deviation|Mean
712211|NCT00194077|Primary|Time in Weeks to Discontinuation|Time in weeks to discontinuation due to any reason, including mood event, adverse event, or other.|up to 72 weeks|||time in weeks to discontinuation||95% Confidence Interval|Mean
712218|NCT00194532|Secondary|Microbiologic Cure|Elimination or decrease of causative uropathogen(s) in the mid-stream urine culture at follow-up|1-15 days post therapy|Per protocol. Participants were eligible for analysis if they had an enrollment urine containing uropathogens and a urine specimen taken at follow-up.||participants|||Number
712219|NCT00194532|Primary|Clinical Cure|Participants with clinical cure, i.e. free of urinary tract symptoms and requiring no further antibiotic treatment, to assess the efficacy of a 3-day regimen of cefpodoxime compared to ciprofloxacin|28-30 days post therapy|modified ITT||participants|||Number
712220|NCT00194610|Primary|Chronic Prostatitis Symptom Index (CPSI-F)|CPSI-F was adapted from the CPSI, in order to document the location of pain, with working pertinent to female anatomy. The CPSI-F was scored on a range of 0-83 (0-61 in the pain domain, 0-10 in the urination domain, 0-6 in the impact of symptoms domain, and 0-6 in the quality of life domain), with higher scores denoting worse symptoms.|3 months|Total number of subjects was based on clinical volume, and subjects were randomized into each of two arms.||Total CPSI-F||Standard Deviation|Mean
712221|NCT00194675|Secondary|Serum Hormone Levels: Total Testosterone, Free Testosterone, and Dihydrotestosterone(DHT), Dehydroepiandrosterone(DHEA), and Androstenedione.||Baseline, 3-months, 6-months|per protocol||ng/ dL||Standard Deviation|Mean
712222|NCT00194675|Secondary|Signs and Symptoms Benign Prostatic Hyperplasia (BPH): Post-voiding Residual (PVR) Urinary Volume||Baseline, 3-months, 6-months|||cc||Standard Deviation|Mean
712223|NCT00194675|Secondary|Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) in Hypogonadal Men (Uroflow)||Baseline, 3-months, 6-months|per protocol||cc/sec||Standard Deviation|Mean
712224|NCT00194675|Secondary|The Effects of T Alone or in Combination With Dutasteride on Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) in Hypogonadal Men With Benign Prostatic Hyperplasia. (International Prostate Symptom Score)|International Prostate Symptom Score to assess lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). Minimum score = 0, maximum score = 35; mildly symptomatic score = 0-7; moderately symptomatic score = 8-19; severely symptomatic score = 20-35; no subscales.|Baseline, Month 3, Month 6|per protocol||score||Standard Deviation|Mean
712225|NCT00194675|Secondary|Androgen-responsive Gene Expression and Proliferation in the Stromal and Epithelial Compartments of the Prostate||6-months||||||
712226|NCT00194675|Secondary|Serum and Intraprostatic Hormone Levels: Prostate Specific Antigen (PSA)||Baseline, Month 6|per protocol||ng/ ml||Standard Deviation|Mean
712227|NCT00194675|Primary|Effects of Testosterone Gel Alone or in Combination With Oral Dutasteride on Prostate Volume in Hypogonadal Men With Benign Prostatic Hyperplasia.||Baseline, Month 6|per protocol||cubic centimeters||Standard Deviation|Mean
712228|NCT00194792|Secondary|Correlation of Molecular Markers With Response, Time to Progression, and Survival||Weekly during CHB and XMN and pacitaxel|Molecular marker data was not collected for this cohort and thus not possible to report results for this outcome.|||||
712229|NCT00194792|Primary|Number of Participants With Dose Reduction, Treatment Interruption, or Treatment Discontinuation|Count of patients with dose reduction, treatment interruption, or treatment discontinuation.|During adjuvant and neoadjuvant chemotherapy|||Participants|||Count of Participants
712233|NCT00194792|Primary|Number of Participants With Microscopic Pathologic Complete Response and Macroscopic Pathologic Complete Response|Defined as no evidence of microscopic invasive tumor at the primary site or in the regional lymph nodes at the time of definitive surgical resection and the examining pathologist cannot identify gross residual tumor mass in the surgical specimen.|From date of treatment start to surgery|||Participants|||Count of Participants
712234|NCT00194792|Primary|Number of Participants With Clinical Response|Defined as a > 50% decrease in sum of the products of the perpendicular diameters of bidimensionally measurable disease.|1 month|||Participants|||Count of Participants
712235|NCT00194896|Secondary|Patients Positive for T Cell Responses to Islet Proteins at 36 Months.|Number of participants positive for T cell reactivity to islet proteins at 36 months.|36 months|||participants|||Number
712236|NCT00194896|Primary|Changes in Beta Cell Function Assessed by Fasting and Stimulated C-peptide Measured at 36 Months.|Changes in beta cell function assessed by fasting and stimulated C-peptide measured at 36 months.|36 months|Analysis per protocol||ng per ml||Standard Deviation|Mean
712237|NCT00195013|Primary|Change in Peripheral Neuropathy Score|"Used the clinical total neuropathy score scale (TNSc). The presence of sensory, motor, pin sensibility, vibration sensibility, DTR, autonomic symptoms was assessed. For each item, the possible score ranged between 0 (normal) and 4 (worst possible result).
Outcomes calculated as neuropathy score value at 10 Weeks minus neuropathy score value at Baseline. Increased score value indicates increased neuropathy severity."|Duration of study, approximately 10 weeks per subject|||Change in Total Neuropathy Score||Full Range|Mean
712238|NCT00195039|Secondary|Number of Participants With Targeting of 177Lu-J591 to Known Tumor Sites.||Scans will be performed between day 6 and 8.|||Participants|||Count of Participants
712239|NCT00195039|Secondary|Assess the Survival Rate of Patients Following Treatment.||From baseline through study completion|||months||95% Confidence Interval|Median
712240|NCT00195039|Secondary|Number of Participants With Hematological Toxicity Relative to Bone Marrow Involvement (Bone Scan Index).|Bone scan score determined for each patient and related to the degree of hematological toxicity quantified by % decline of nadir platelet count relative to baseline count.|Bone scan will be performed at baseline and Day 85.|||participants|||Number
712241|NCT00195039|Secondary|Define the Incidence of Human Anti-J591 Antibody (HAHA) Response.||HAHA samples will be drawn at baseline and Day 85.|Samples were collected but data necessary to summarize this outcome measure was not collected because the study team felt that there was adequate data from previous phase I studies, including repeating dosing of the study drug in this study and others that were performed prior to this study’s completion.|||||
712242|NCT00195039|Secondary|Define the Toxicity of 177Lu-J591 Given as Single Dose.|"Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.
Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL*.
Grade 3 Severe or medically significant but not immediately life-threatening hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL**.
Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE."|From baseline until end of treatment phase (12 weeks)|||Participants|||Count of Participants
712243|NCT00195039|Secondary|Define the Duration of Biochemical PSA and/or Measurable Disease Response.|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions, Complete Response (CR) = Disappearance of all target lesions, Partial Response (PR) = A </=30% decrease in the sum of the longest diameter of target lesions, taking as reference the Baseline sum longest diameter, Stable Disease (SD) = Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started, Progressive Disease (PD) = A >/=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started, or the appearance of one or more new lesions|At baseline, and up to death|||months||95% Confidence Interval|Median
712244|NCT00195039|Primary|Define the Measurable Disease Response Rate.|"Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study"|Disease will be assessed at baseline and day 85.|Only 12 patients had measurable disease||Participants|||Count of Participants
712245|NCT00195039|Primary|Define the PSA Response Rate.|PSA response rate corresponds to change form baseline in PSA at any of the time points specified.|At baseline, Day 1, 29, 43, 57, 85, week 18, week 24 & every 12 weeks|||Participants|||Count of Participants
712246|NCT00187200|Secondary|Left Ventricular Ejection Fraction (LVEF)|Ejection fraction is a measurement of the percentage of blood leaving your heart each time it contracts. The left ventricle is the heart's main pumping chamber, so ejection fraction is usually measured only in the left ventricle (LV).|Randomization and 9 months|||percentage||Standard Deviation|Mean
712247|NCT00187200|Secondary|6 Minute Hall Walk Distance Test (6-MHWD)|Patients were considered non-responders if the 6-MHWD had not improved by greater than or equal to 10% compared to baseline. This statement is accurate and appropriate.|6 months|||participants|||Number
712248|NCT00187200|Secondary|NYHA Class Progression|New York Heart Association (NYHA) functional classification provides a way of classifying the extent of heart failure. It places patients in one of four categories based on how much they are limited during physical activity; the limitations/symptoms are in regard to normal breathing and varying degrees in shortness of breath and/or angina pain.|6 months|Per protocol analysis||participants|||Number
712281|NCT00189423|Secondary|Survival to Hospital (e.g., Intensive Care Unit) Admission|Number of patients who survived to hospital or ICU admission after being transported to the emergency department (ED) after out-of-hospital cardiac arrest.|Time of hospital admission, up to 1 day after cardiac arrest|Population is a modified Intent to Treat (mITT) population who received EMS CPR per study protocol after meeting initial inclusion criteria and also met final inclusion criteria.||patients|||Number
712249|NCT00187200|Primary|CRT Responder Rate|Patients underwent baseline NYHA class and 6-minute hall walk distance (6-MHWD) assessment. After device implantation AV delays were optimized and all patients were programmed to simultaneous biventricular (BiV) pacing. At the 3-month follow-up, the NYHA class and 6-MHWD were reassessed. Non-responders were randomized 1:1 to either sequential BiV pacing with VV optimization or simultaneous BiV pacing. The responder rate at 6 months post randomization was compared between the two groups. Which is why the numbers are broken further down in the Outcome Measure table.|6 months|Per protocol analysis.||participants|||Number
712250|NCT00187226|Primary|Local Tumor Control|Local tumor control was determined by Magnetic Resonance Imaging (MRI) of the brain and spine performed after radiation therapy. Imaging studies were performed every 3-4 months during the first three years and then every 6 months through five years. Imaging studies demonstrating tumor progression were electronically registered to the imaging data used to plan therapy. Local failure included tumor progression within the volume that received the prescribed dose of irradiation.|12 months after the enrollment of the last therapeutic patient|Patients with Ependymoma, Craniopharyngioma, Low-grade Glioma, and High-grade Glioma were analyzed by diagnosis.||Proportion of patients||95% Confidence Interval|Log Mean
712251|NCT00187486|Secondary|Progression Free Survival|Progression based on MR imaging using the Modified McDonnald Criteria defined as 25% increase in sum of products of all measured lesions or any new lesion|every 2 months measure by MR imaging, up to 39 months|||months||Full Range|Median
712252|NCT00187486|Primary|Overall Survival|Patients were monitored until death|assessment of survival was every 2 months, up to 181 weeks|The analysis was per protocol, and intention to treat. Median overall survival measured from the date of registration was the primary endpoint.||months||Full Range|Median
712253|NCT00187655|Primary|Effect of OAT3 on Renal Secretion of Cefotaxime IV Based on Genotype|Participants were stratified by their OCT3 genotype, heterozygous vs homozygous. The renal clearance of cefotaxime was measured by urine content of cefotaxime metabolites in participants after the single IV push administration of 2 grams of cefotaxime.|post dose up to 24 hours|The OAT3 Ile305Phe variant was determined to be heterozygous or homozygous for each healthy participant.||mL/min||Standard Deviation|Mean
712254|NCT00187681|Primary|Glucose Lowering Response to Metformin|To test whether individuals with genetic variants of human organic cation transporter, OCT1, exhibit altered glucose lowering response to metformin we will measure the difference in area under the glucose concentrations-time curve (Glucose AUC) following oral glucose tolerance test.|0 to 180 minutes|20 participants were analyzed as per protocol. The sample size of 20 subjects enabled us to detect a significant difference (at the p < 0.05 level; α = 0.05, β = 0.80) in the pharmacodynamics of metformin between individuals who are homozygous for the reference OCT1 and those who carry an OCT1-R61C, OCT1-G401S or OCT1-G465R allele.||min * mg/dL||Standard Deviation|Mean
712255|NCT00187681|Primary|Area Under the Curve (AUC) of Blood Concentration-time of Metformin|To test whether individuals with genetic variants of human organic cation transporter, OCT1, exhibit altered pharmacokinetics of metformin, the difference in AUC of blood concentration-time of metformin between reference and variant groups will be measured.|0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, and 24 hours|20 participants were analyzed as per protocol. The sample size of 20 subjects enabled us to detect a significant difference (at the p < 0.05 level; α = 0.05, β = 0.80) in the pharmacokinetics of metformin between individuals who are homozygous for the reference OCT1 and those who carry an OCT1-R61C, OCT1-G401S or OCT1-G465R allele.||hour * µg/L||Standard Deviation|Mean
712256|NCT00187720|Primary|Renal Clearance of Metformin|To test whether individuals with genetic variants of the human organic cation transporter, OCT2, exhibit altered renal elimination of metformin we will measure the difference in renal clearance between reference and variant groups.|0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours|Analysis was per protocol. The sample size of 23 subjects will enable us to detect a significant difference (at the p < 0.05 level; α = 0.05, β = 0.80) in the renal clearance of metformin between individuals who are homozygous for the reference OCT2 and those who carry the OCT2 variant A270S allele.||mL/min||Standard Deviation|Mean
712257|NCT00187876|Primary|International Knee Documentation Committee (IKDC) Form|The IKDC Subjective Evaluation Form is scored by summing the scores for the individual items and then transforming the score to a scale that ranges from 0-100. A score of 100 is interpreted to mean no limitation with activities of daily living and the absence of symptoms.|24 month period|||score||95% Confidence Interval|Mean
712260|NCT00189098|Secondary|Number of Patients Who Underwent Ear Nose and Throat Surgery Between 12 Weeks and 1 Year Follow-up.|After 12 weeks follow-up irrespective of the presence or absence of otorrhea the study medication was discontinued. After the first 12 weeks local otorhinolaryngologists and paediatricians were free to manage symptoms of otorrhea according to their regular practice. Parents kept a diary between 12 weeks and 1 year follow-up where Ear Nose and Throat Surgery was noted. This outcome describes the number of patients who underwent Ear Nose and Throat Surgery between 12 weeks and 1 year follow-up.|between 12 weeks and 1 year follow-up|||participants|||Number
712739|NCT00197392|Secondary|Device Related Adverse Events|Number of Device Related Adverse Events|Implanted subjects to time of explant|There were 8 device-related events, 7 of which were in subjects that received a standard catheter. None of the 8 subjects were proven infections.||events|||Number
712261|NCT00189098|Secondary|Number of Patients Who Used Systemic Antibiotics Other Than the Study Medication Between 12 Weeks and 1 Year Follow-up.|Parents kept a diary of study medication and additional medication used for their child’s’ ear disease, including additional use of systemic antibiotics other than the study medication. These data were collected at the follow-up visits.|between 12 weeks and 1 year follow-up|Parents kept a diary of study medication and additional medication used for their child’s’ ear disease, including additional use of systemic antibiotics other than the study medication. These data were collected at the follow-up visits. Some parents did not fill in the required forms and these were excluded in this analysis.||participants|||Number
712262|NCT00189098|Secondary|Number of Patients Who Used Systemic Antibiotics Other Than the Study Medication Between 6 and 12 Weeks Follow-up.|Parents kept a diary of study medication and additional medication used for their child’s’ ear disease, including additional use of systemic antibiotics other than the study medication. These data were collected at the follow-up visits.|between 6 and 12 weeks follow-up|Parents kept a diary of study medication and additional medication used for their child’s’ ear disease, including additional use of systemic antibiotics other than the study medication. These data were collected at the follow-up visits. Some parents did not fill in the required forms and these were excluded in this analysis.||participants|||Number
712263|NCT00189098|Secondary|Number of Patients Who Used Additional Antibiotic Eardrops Between 12 Weeks to 1 Year Follow-up|Parents kept a diary of study medication and additional medication used for their child’s’ ear disease, including eardrops. These data were collected at the follow-up visits.|between 12 weeks to 1 year follow-up|Parents kept a diary of study medication and additional medication used for their child’s’ ear disease, including eardrops. These data were collected at the follow-up visits. Some parents did not fill in the required forms and these were excluded in this analysis. Therefore number of participants analyzed differ from the flow-chart.||participants|||Number
712264|NCT00189098|Secondary|Number of Patients Who Used Additional Antibiotic Eardrops Between 6 to 12 Week Follow-up|Parents kept a diary of study medication and additional medication used for their child’s’ ear disease, including eardrops. These data were collected at the follow-up visits.|Between 6 to12 week follow up|Parents kept a diary of study medication and additional medication used for their child’s’ ear disease, including eardrops. These data were collected at the follow-up visits. Some parents did not fill in the required forms and these were excluded in this analysis. Therefore number of participants analyzed differ from the flow-chart.||participants|||Number
712265|NCT00189098|Primary|Number of Participants With Otomicroscopic Signs of Otorrhea in Either Ear|The primary endpoint was otomicroscopic signs of otorrhea in either ear in the presence of a tympanostomy tube or tympanic membrane perforation at 6 and 12 weeks and 1 year follow-up. At these follow-up moments the participants were checked for the presence of otorrhea using an otomicroscope.|6, 12 weeks and 1 year follow-up.|intention to treat||participants|||Number
712266|NCT00189137|Secondary|The Percentage of Patients Alive Without Disease at 2 Years|Disease-free survival|2 years|||percentage of patients|||Number
712267|NCT00189137|Primary|Percentage of Patients Hospitalized in Each Arm.|To contrast the proportion of treated patients hospitalized subsequent to treatment with gemcitabine and docetaxel as compared to doxorubicin and ifosfamide as neoadjuvant or adjuvant therapy of poor prognosis soft tissue sarcoma.|12 weeks|||percentage of patients hospitalized|||Number
712268|NCT00189202|Secondary|Blood Pressure Control|To determine whether SRL-based steroid avoidance maintenance regimen is associated with decreased rates of metabolic complications. Endpoint is number of people who had their blood pressure in the target control range with or without medication|12 months|||Participants|||Count of Participants
712269|NCT00189202|Secondary|Drug-treated Dyslipidemic Syndrome|To determine whether SRL-based steroid avoidance maintenance regimen is associated with decreased rates of metabolic complications. Endpoint is drug-treated dyslipidemic syndrome|12 months|||Participants|||Count of Participants
712270|NCT00189202|Secondary|Incidence of Post Transplant Diabetes|To determine whether SRL-based steroid avoidance maintenance regimen is associated with decreased rates of metabolic complications. Endpoint is incidence of posttransplant diabetes mellitus|12 months|||Participants|||Count of Participants
712271|NCT00189202|Primary|One-year Patient Survival|To test the efficacy of SRL-based steroid avoidance regimen in high risk de novo renal allograft recipients. Efficacy endpoints for this objective is: one-year patient survival|12 months|||Participants|||Count of Participants
712272|NCT00189202|Primary|One-year Graft Survival|To test the efficacy of SRL-based steroid avoidance regimen in high risk de novo renal allograft recipients. Efficacy endpoints for this objective is: one-year graft survival|12 months|||Participants|||Count of Participants
712273|NCT00189202|Primary|Cumulative One-year Acute Rejection Rates|To test the efficacy of Sirolimus (SRL)-based steroid avoidance regimen in high risk de novo renal allograft recipients. Efficacy endpoints for this objective is: cumulative one-year acute rejection rates of the transplant|12 months|||Participants|||Count of Participants
712274|NCT00189306|Secondary|Number of Participants Cleared of Superficial Basal Cell Carcinoma at 12 Weeks|Number of participants cleared at 12 weeks(the number of subjects with no clinical evidence of superficial basal cell carcinoma at the target tumor site at the 12-week posttreatment visit)|12 week posttreatment visit|Two data sets were analyzed: intent-to-treat (ITT), consisting of all enrolled subjects and per-protocol (PP), consisting of ITT subjects who were free from major protocol violations, and who applied at least 60% of the doses required by the dosing regimen.||participants|||Number
712275|NCT00189306|Primary|Number of Participants With Sustained Clearance Rate of Superficial Basal Cell Carcinoma (sBCC)|Number of participants clinically clear of superficial basal cell carcinoma at the treated target tumor site at the 12-week posttreatment visit (ie, initial clearance rate) who remain clear during a 5 year follow-up period.|5 years|2 data sets: ITT - all enrolled subjects and PP - ITT subjects free from major protocol violations and applied at least 60% of doses required||participants|||Number
712276|NCT00189423|Secondary|Neurological Recovery at Hospital Discharge, 30 Days, 90 Days, and 1 Year [Measured by Cerebral Performance Category (CPC), Overall Performance Category (OPC), and Health Utilities Index Mark 3 (HUI3); Cognitive Abilities Screening Instrument (CASI)]||Various: hospital discharge through 1-year survival||||||
712277|NCT00189423|Secondary|Survival to 365 Days|Number of patients who are alive 365 days after the index cardiac arrest.|365 days following cardiac arrest|Population is a modified Intent to Treat (mITT) population who met initial and final inclusion criteria.||patients|||Number
712282|NCT00189423|Secondary|Return of Spontaneous Circulation (ROSC)|Number of subjects who had ROSC, defined as any return of spontaneous circulation for any duration, reported during resuscitation in the field by EMS.|Time of cardiac arrest until discontinuation of efforts|Population was a modified Intent to Treat (mITT) population that consisted of patients who met all initial and final inclusion criteria.||patients|||Number
712283|NCT00189423|Secondary|Major Adverse Event Rate as Measured by Number of Patients With One or More Adverse Events|Number of patients with one or more major adverse events, through hospital discharge. Major adverse events included: death, rearrest, pulmonary edema, seizure, bleeding requiring intervention, rib/sterna fracture, pneumothorax, hemothorax, cardiac tamponade, cerebral bleeding, aspiration, internal organ injury.|Time from cardiac arrest through hospital discharge (an average of 12 days for subjects surviving to hospital discharge|Population is a modified Intent to Treat (mITT) population consisting of patients who met all initial and final inclusion criteria.||patients|||Number
712284|NCT00189423|Primary|Number of Patients Who Survived to Hospital Discharge With Favorable Neurologic Function Defined as MRS Score <=3|favorable neurologic function is defined as modified Rankin Scale (MRS) score <= 3. Modified Rankin Scale measures functional outcome in stroke. It is a scale of 0-5 where 0=no symptoms at all and 5=severe disability: bedridden, incontinent, and requiring constant nursing care and attention.|When the subject is discharged from the hospital; an average of 12 days after cardiac arrest for subjects surviving to hospital discharge|The population was a modified Intent to Treat (mITT) population who received EMS CPR per study protocol after meeting initial inclusion criteria and who were finally included in the final analysis population after meeting final inclusion criteria.||patients|||Number
712285|NCT00189436|Secondary|Spirometry Readings||3 weeks||||||
712286|NCT00189436|Secondary|Urinary Cortisol||3 weeks||||||
712287|NCT00189436|Primary|Wheezing/Asthma/Bronchospasm Relapse Rate|Asthma relapse rate was 6.5% and 4% in the nebulized budesonide and standard care groups, respectively|3 weeks|||percentage of cases of asthma relapse|||Number
712288|NCT00189462|Primary|Incidence of Acute Otitis Media||16 weeks|||participants with AOM|||Number
712289|NCT00189475|Primary|Nasal Secretion Weights||6 days after naturally acquiring an upper respiratory infection|||grams||Standard Error|Mean
712290|NCT00189488|Secondary|Area Under the Curve (AUC) of Mouth and Throat Soreness Score|"The modified Oral Mucositis Daily Questionnaire (OMDQ) is a self-reported tool that evaluates overall health, mouth and throat soreness (MTS) and activity limitations due to MTS.
The modified OMDQ was completed once daily beginning with the first day of study drug administration through day 28.
The area under the curve of mouth and throat soreness score was assessed from the question How much mouth and throat soreness did you experience in the past 24 hours? Participants answered on a scale from 0 (no soreness) to 4 (extreme soreness)."|The first day of study drug administration through Day 28.|Primary analysis set||MTS score * days||Standard Deviation|Mean
712291|NCT00189488|Secondary|Duration of Hospitalization|Duration of hospitalization was defined as the number of days a participant stayed in hospital (hospitalized) during the period starting from the day of the transplant (Day 0) to the 100th day following the transplant.|From transplant (Day 0) until Day 100|Primary analysis set||days||Standard Deviation|Mean
712292|NCT00189488|Secondary|Number of Participants With Parenteral or Transdermal Opioid Analgesic Use|Includes nonprophylactic intravenous opioid analgesics (fentanyl, morphine, morphine sulphate, hydromorphone, meperidine) and transdermal opioid analgesics (fentanyl patch) for the indication of oral mucositis and dysphagia.|From transplant (Day 0) until Day 100|Primary Analysis Set||Participants|||Number
712293|NCT00189488|Secondary|Duration of Severe Oral Mucositis (WHO Grade 3 and 4)|The duration of severe oral mucositis was calculated as the number of days from the onset of severe mucositis (first time a WHO grade of 3 or 4 was observed) to the last day when severe mucositis was observed. If oral mucositis assessments were recorded as missed visits immediately prior to or immediately after severe mucositis was recorded, the missed visits were considered to be severe oral mucositis.|From transplant (Day 0) until Day 100|Primary Analysis Set||days||Standard Deviation|Mean
712294|NCT00189488|Secondary|Number of Participants With Severe (Grade 3 or 4) Oral Mucositis|"Oral cavity assessments were performed by a trained assessor using the World Health Organization (WHO) oral toxicity scale. Daily oral mucositis assessments were performed:
while participants were hospitalized, including the day of discharge (maximum until day 28);
after discharge until the oral mucositis grade returns to a WHO grade ≤ 2.
The WHO oral toxicity criteria are: Grade 0 = None; Grade 1 = Soreness, erythema; Grade 2 = Erythema, ulcers, ability to eat solids; Grade 3 = Ulcers, requires liquid diet; Grade 4 = Alimentation not possible."|From transplant (Day 0) until Day 100|Primary Analysis Set||Participants|||Number
712295|NCT00189488|Secondary|Number of Participants With Day 11 Methotrexate Graft Versus Host Disease Prophylaxis Administration|Low dose methotrexate is widely used in regimens to prophylax against acute GVHD. Methotrexate was administered on days 1, 3, 6 and 11 (toxicity allowing) at doses of 15, 10, 10 and 10 mg/m^2, respectively.|Day 11|Primary Analysis Set||Participants|||Number
712296|NCT00189488|Primary|Number of Participants With Severe (Grade 3 and 4) Acute Graft Versus Host Disease (GVHD)|"GVHD was graded using the modified Keystone Criteria weekly during the first 2 months after stem cell infusion, then every other week until Day 100.
Severity was determined clinically (based on physical exam and laboratory serum values) and from biopsies of affected organs whenever possible. The degree of GVHD in individual organs was scored by at least 2 assessors.
Grade 3 GVHD = total bilirubin 3.1 - 15.0 mg/dL or ≥ 1000 mL/day diarrhea or severe abdominal pain with/without ileus.
Grade 4 GVHD = skin involvement with bullous formation or total bilirubin > 15.0 mg/dL."|From transplant (Day 0) until Day 100|Primary Analysis Set (consisting of all randomized participants) with GVHD assessments. Efficacy analyses were according to randomized treatment assignment.||Participants|||Number
712312|NCT00195260|Secondary|Number of Participants With Change From Baseline in Physical Examination|Physical examinations included body weight, height and vital signs and only finding that exceeded the criterion for PCS was weight. Criteria for weight was: an increase or decrease of >=10% from baseline.|Baseline up to end of treatment (Week 95)|Safety population included all participants who had taken at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable (at least 1 on-therapy assessment) for this measure for each group respectively.||participants|||Number
712740|NCT00197392|Secondary|Intraluminal Colonization on Catheters|Number of catheters with Bacterial colonization verified using fluorescence.|Implant of subjects to post implant|||catheters|||Number
712297|NCT00189488|Secondary|Number of Participants With Grade 2 to 4 Acute Graft Versus Host Disease (GVHD)|"GVHD was graded using the modified Keystone Criteria weekly during the first 2 months after stem cell infusion, then every other week until Day 100.
Severity was determined clinically (based on physical exam and laboratory serum values) and from biopsies of affected organs whenever possible. The degree of GVHD in individual organs was scored by at least 2 assessors.
Grade 2 GVHD = > 50% skin involvement or total bilirubin 2.0 - 3.0 mg/dL or 500 - 999 mL/day diarrhea, or persistent nausea with histologic evidence.
Grade 3 GVHD = total bilirubin 3.1 - 15.0 mg/dL or ≥ 1000 mL/day diarrhea or severe abdominal pain with/without ileus.
Grade 4 GVHD = skin involvement with bullous formation or total bilirubin > 15.0 mg/dL."|From transplant (Day 0) until Day 100|Primary Analysis Set (consisting of all randomized participants) with GVHD assessments.||Participants|||Number
712304|NCT00195260|Other Pre-specified|Gene Expression at Baseline|Gene expression profile was evaluated by measuring transcript levels of messenger RNA (mRNA) in peripheral blood samples. Expression profiling of mRNA: done to measure the expressed genome of mRNA transcripts or done in a gene-specific targeted manner.|Baseline|Data was not analyzed as the analysis was cancelled due to lack of samples provided from sites.|||||
712305|NCT00195260|Secondary|Area Under the Concentration-Time Curve (AUC)|AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. Steady state concentration was achieved at Day 15.|0 hour (pre-dose) on Day 1, 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 (0 hour [pre-dose] on Day 15) hours post-dose on Day 14|Analysis population included all participants who had taken at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants evaluable for specific time points.||ng*hour/mL||Standard Deviation|Mean
712306|NCT00195260|Secondary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 hour (pre-dose) on Day 1, 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 (0 hour [pre-dose] on Day 15) hours post-dose on Day 14|Analysis population included all participants who had taken at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants evaluable for specific time points.||hours||Standard Deviation|Mean
712307|NCT00195260|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 hour (pre-dose) on Day 1, 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 (0 hour [pre-dose] on Day 15) hours post-dose on Day 14|Analysis population included all participants who had taken at least one dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants evaluable for specific time points.||hours||Full Range|Median
712308|NCT00195260|Secondary|Maximum Observed Plasma Concentration (Cmax)||0 hour (pre-dose) on Day 1, 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 (0 hour [pre-dose] on Day 15) hours post-dose on Day 14|Analysis population included all participants who had taken at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants evaluable for specific time points.||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
712309|NCT00195260|Secondary|Progression Free Survival (PFS) in Part 2|Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for PD, or from death CRFs).|Part 2 Baseline until death or 3, 6, 9 and 12 months after treatment discontinuation|Efficacy evaluable population: participants who received at least 1 cycle (15 doses) of study medication, had no eligibility violations, did not use prohibited anti-cancer treatment, had baseline disease assessment, at least 1 disease assessment post-baseline/had experienced clinical progression/death before first post-baseline disease assessment.||weeks||95% Confidence Interval|Median
712310|NCT00195260|Secondary|Overall Survival (OS) in Part 2|Time in weeks from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 7. Death was determined from death case report forms (CRFs) or from follow-up contact data (where the participant current status was death).|Part 2 Baseline until death or 3, 6, 9 and 12 months after treatment discontinuation|Efficacy evaluable population: participants who received at least 1 cycle (15 doses) of study medication, had no eligibility violations, did not use prohibited anti-cancer treatment, had baseline disease assessment, at least 1 disease assessment post-baseline/had experienced clinical progression/death before first post-baseline disease assessment.||weeks||95% Confidence Interval|Median
712311|NCT00195260|Secondary|Number of Participants With Change From Baseline in Opthalmologic Examination|Ophthalmologic evaluation included visual acuity, funduscopic examination, and any clinically-significant abnormality.|Baseline up to end of treatment (Week 95)|Safety population included all participants who had taken at least 1 dose of study medication.||participants|||Number
712741|NCT00197392|Secondary|Class of Bacterial Agent Causing Proven Infection|Type of bacterial agent related to proven infection in Bactiseal EVD and Standard EVD|Implantation of subject to post implant|All subjects included in the MITT, Evaluable and Per-Protocol population.||participants|||Number
712313|NCT00195260|Secondary|Change From Baseline in Karnofsky Performance Score|Karnofsky performance score is used to quantify participant’s general well-being and activities of daily life and participants are classified based on their functional impairment. Karnofsky performance score is 11 level score which ranges between 0 (death) to 100 (complete healthy status). Higher score means higher ability to perform daily tasks.|Baseline up to end of treatment (Week 95)|Data for this pre-specified outcome was collected but not statistically summarized for analysis as there were no clinically significant changes observed.|||||
712314|NCT00195260|Secondary|Concomitant Medications Used for Management of Adverse Events (AEs)|Number of participants taking any non-study medications which were administered from Day 1 up to end of treatment (Week 95) as a management of an AE was to be reported.|Day 1 up to end of treatment (Week 95)|Data for this pre-specified outcome measure was not statistically summarized for analysis, but collected and reported in individual participant listings as planned.|||||
712315|NCT00195260|Secondary|Number of Participants With Change From Baseline in Electrocardiogram (ECG) and Chest X-ray|Number of participants with PCS ECG findings is reported on-therapy (OT) and at final visit (FV). Criteria for PCS ECG findings: heart rate (HR) =<45 beats/minute (bpm) and decrease (Dec) >15/>=120 bpm and decrease of >15 bpm; PR interval (Int) >=220 millisecond (msec), increase (Inc) >=20 msec, QRS Int >=120 msec, corrected QT (QTc) and QTc using fridericia formula(QTcF) Int >500 msec, increase >60 msec; no sinus rhythm; overall ECG abnormal. Participants with at least 1 measurement exceeding the criteria for PCS are reported.|Baseline up to end of treatment (Week 95)|Safety population included all participants who had taken at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable (at least 1 on-therapy assessment) for this measure and 'n' represents participants evaluable under each category for each group respectively.||participants|||Number
712316|NCT00195260|Secondary|Number of Participants With Change From Baseline in Laboratory Test Results|Criteria for potentially clinically significant (PCS) laboratory values: albumin <20, hemoglobin <80 gram/liter(g/L); alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase >5*upper limit of normal(ULN) milliunit/milliliter(mU/mL); bilirubin total, creatinine>3*ULN micromole/L; calcium <1.75 and >3.1,potassium <3 and >6, sodium <130, glucose <2.2,phosphorous <0.6 millimole/L; international normalized ratio >2*ULN, partial thromboplastin time, prothrombin time >2*ULN seconds; platelet count <50*10^9/L. Participants meeting at least 1 PCS criteria are reported.|Baseline up to end of treatment (Week 95)|Safety population included all participants who had taken at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable (at least 1 on-therapy laboratory assessment) for this measure for each group respectively.||participants|||Number
712317|NCT00195260|Secondary|Maximum Tolerated Dose (MTD) for Prolonged Use|MTD for prolonged use was the highest dose level at which not more than 1 of 6 participants experienced DLT after 21 days of treatment (Cycle 1) and was selected as recommended dose in Phase 2, due to substantial number of Grade 2 gastrointestinal toxicities observed in the MTD lead-in cohort (500 mg).|Part 1 Day 1 up to Day 28|Safety population included all participants enrolled in a dose escalation cohort who had taken at least 1 dose of study medication.||mg|||Number
712318|NCT00195260|Primary|Maximum Tolerated Dose (MTD) in Part 1|MTD: highest dose level at which not more than 1 of 6 participants experienced DLT after 21 days of treatment (Cycle 1). DLT included any grade 3 or 4 clinically-evident non-hematologic toxicity, grade 4 neutropenia of >= 7-day duration or with fever >= 38.5 degrees Celsius (febrile neutropenia); grade 4 thrombocytopenia >= 2-day duration or with bleeding requiring platelet transfusion, any clinically-significant grade >= 2 toxicity that requires >=14 days to resolve (to =< grade 1) which occurred in first 21 days of study and considered at least possibly related to bosutinib.|Part 1 Day 1 up to Day 28|Safety population included all participants enrolled in a dose escalation cohort who had taken at least 1 dose of study medication.||mg|||Number
712319|NCT00195260|Primary|Number of Participants With Best Overall Response (BOR) in Part 2|BOR: investigator assessment by modified RECIST, recorded from treatment start until disease progression/recurrence. Complete Response: disappearance of all lesions. PR: >=30% decrease in SLDs of TLs taking as reference baseline SLD. PD: >=20% increase in SLD of TLs taking as reference smallest SLD since treatment start, or appearance of >=1 new lesion. Stable disease: neither shrinkage for PR nor increase for PD taking as reference smallest SLD since treatment start.|Part 2 Baseline, last week (Day 15 to 23) of cycles 2, 4, 6, 8 and thereafter every 3 cycles up to 30 days after last dose|Efficacy evaluable population: participants who received at least 1 cycle (15 doses) of study medication, had no eligibility violations, did not use prohibited anti-cancer treatment, had baseline disease assessment, at least 1 disease assessment post-baseline/had experienced clinical progression/death before first post-baseline disease assessment.||participants|||Number
712320|NCT00195260|Primary|Number of Participants With Best Overall Response (BOR) in Part 1|BOR:investigator assessment by modified Response Evaluation Criteria in Solid Tumors (RECIST), recorded from treatment start until disease progression/recurrence. Complete Response:disappearance of all lesions. Partial Response (PR):>=30% decrease in sum of longest diameters (SLDs) of target lesions (TLs) taking as reference baseline SLD. Progressive disease (PD):>=20% increase in SLD of TLs taking as reference smallest SLD since treatment start, or appearance of >=1 new lesion. Stable disease: neither shrinkage for PR nor increase for PD taking as reference smallest SLD since treatment start.|Part 1 Baseline, last week (Day 15 to 23) of cycles 2, 4, 6, 8 and thereafter every 3 cycles up to 30 days after last dose|Efficacy evaluable population: participants who received at least 1 cycle (15 doses) of study medication, had no eligibility violations, did not use prohibited anti-cancer treatment, had baseline disease assessment, at least 1 disease assessment post-baseline/had experienced clinical progression/death before first post-baseline disease assessment.||participants|||Number
712321|NCT00195260|Primary|Duration of Most Frequently Observed Adverse Events (AEs)|The most frequently observed treatment-emergent AEs were gastrointestinal disorders which included diarrhea, nausea and vomiting. Duration of AE per event is calculated as AE stop date minus AE start date plus 1.|Baseline up to 30 days after last dose|Safety population included all participants who had taken at least 1 dose of study medication.||days||Full Range|Median
712322|NCT00195260|Primary|Number of Participants With Adverse Events (AEs) by Seriousness|Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Participants with multiple occurrences of an AE within a category were counted once within the category.|Baseline up to 30 days after last dose|Safety population included all participants who had taken at least 1 dose of study medication.||participants|||Number
712323|NCT00195260|Primary|Number of Participants With Dose-limiting Toxicities (DLT) in Part 1|DLT included any grade 3 or 4 clinically-evident non-hematologic toxicity, grade 4 neutropenia of greater than or equal to (>=) 7-day duration or with fever >= 38.5 degrees Celsius (febrile neutropenia); grade 4 thrombocytopenia >= 2-day duration or with bleeding requiring platelet transfusion, any clinically-significant grade >= 2 toxicity that requires >=14 days to resolve (to less than or equal to [=<] grade 1) which occurred in first 21 days of study and considered at least possibly related to bosutinib.|Part 1 Baseline up to Day 28|Safety population included all participants enrolled in a dose escalation cohort who had taken at least 1 dose of study medication.||participants|||Number
712324|NCT00195273|Secondary|Mean Creatinine Clearance Rate - 3 Months|Creatinine clearance is a measure of kidney function. Creatinine clearance rate is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Creatinine clearance can be measured directly or estimated using established formulas. For this study, the creatinine clearance rate was calculated using the Nankivell formula. Normal values for healthy, young males are in the range of 100-135 ml/min and for females 90-125 ml/min. A low creatinine clearance indicates poor kidney function.|3 months|All patients who completed 3 months of study drug.||ml/min||Standard Deviation|Mean
712325|NCT00195273|Secondary|Patient and Graft Survival|Graft survival is measured by graft loss which is defined as removal of the transplant.|12 months|All patients who received at least one dose of study drug.||patients|||Number
712326|NCT00195273|Secondary|Number of Patients With Acute Rejection|The diagnosis of acute rejection was made via kidney biopsy (Banff criteria). The Banff criteria are standardized diagnostic categories based on histological assessments (e.g., cell types and distributions). Biopsy was performed before initiation of anti-rejection therapy, or at least within 24 hours of the start of therapy.|3 and 12 months|All patients who received at least one dose of study drug.||patients|||Number
712327|NCT00195273|Primary|Mean Creatinine Clearance Rate|Creatinine clearance is a measure of kidney function. Creatinine clearance rate is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Creatinine clearance can be measured directly or estimated using established formulas. For this study, the creatinine clearance rate was calculated using the Nankivell formula. Normal values for healthy, young males are in the range of 100-135 ml/min and for females 90-125 ml/min. A low creatinine clearance indicates poor kidney function.|12 months|All patients who completed 12 months of study drug.||ml/min||Standard Deviation|Mean
712328|NCT00195338|Secondary|Mean Dose of Concomitant Methotrexate (MTX) and Steroids||Baseline up to Month 66|Data was not analyzed due to low number of participants.||milligram (mg)||Standard Deviation|Mean
712329|NCT00195338|Secondary|Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Months 6, 12, 18, 30, 42, 54 and 66|HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores as 'normal' (no difficulty = 0), 'adequate' (some difficulty = 1), 'limited' (much difficulty = 2), and 'unable to do' (= 3) based on degree of difficulty they experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. HAQ total possible score ranged from 0 (no difficulty) to 60 (unable to do).|Baseline, Months 6, 12, 18, 30, 42, 54 and 66|FAS included all recruited participants who were either initiated or were already receiving etanercept. 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure. The 'n' is signifying those participants who were evaluated for this measure at the specified time points.||units on a scale||Standard Deviation|Mean
712330|NCT00195338|Secondary|Change From Baseline in Number of Joints With Active Synovitis at Months 6, 12, 18, 30, 42, 54 and 66|Synovitis was defined as the inflammation of a synovial (joint-lining) membrane, usually painful, particularly on motion, and characterized by swelling, due to effusion (fluid collection) in a synovial sac.|Baseline, Months 6, 12, 18, 30, 42, 54 and 66|FAS included all recruited participants who were either initiated or were already receiving etanercept. The 'n' is signifying those participants who were evaluated for this measure at the specified time points.||joints||Standard Deviation|Mean
712331|NCT00195338|Secondary|Percentage of Participants With Completion of Study Treatment||Month 12 through Month 72|FAS included all recruited participants who were either initiated or were already receiving etanercept.||percentage of participants|||Number
712332|NCT00195338|Primary|Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Any untoward medical occurrence in a participant who received study treatment was considered an AE without regard to possibility of causal relationship. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a SAE: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to Month 66|Full analysis set (FAS) included all recruited participants who were either initiated or were already receiving etanercept.||percentage of participants|||Number
712333|NCT00195351|Secondary|Number of Patients by Microbiologic Response at Test-of-Cure (TOC) Visit.|Microbiologic response assessed at patient level was combined microbiologic responses for all baseline isolates identified in intra-abdominal/blood cultures. Eradication=baseline isolate not recovered from primary infection site/blood; Presumed Eradication=no material available for culture but response was cure; Persistence=baseline isolate recovered from primary infection site/blood; Presumed Persistence=no material available for culture but response was failure; Superinfection=culture from primary infection site was positive for new isolate not identified at baseline & response was failure.|10-21 days after the last dose of test article|All patients who received ≥1 dose, had clinical evidence of complicated intra-abdominal infection, met all inclusion/exclusion criteria, completed TOC assessment within 8-44 days after last dose, and had baseline culture with ≥1 identified isolate that was susceptible to both study drugs. Patients with an indeterminate assessment were excluded.||participants|||Number
712334|NCT00195351|Secondary|Number of Microbiologically Evaluable Patients With a Clinical Response of Cure at Test-of-Cure (TOC) Visit.|The clinical response was assigned by the investigator according to the protocol-specified guidelines. A clinical response of cure was defined as: the test article and the initial intervention (operative and/or radiologically controlled drainage procedure) resolved the intra-abdominal infection.|10-21 days after the last dose of test article|All patients who received ≥1 dose, had clinical evidence of complicated intra-abdominal infection, met all inclusion/exclusion criteria, completed TOC assessment within 8-44 days after last dose, and had a baseline culture with ≥1 identified isolate that was susceptible to both study drugs. Patients with an indeterminate assessment were excluded.||participants|||Number
712335|NCT00195351|Primary|Number of Clinically Evaluable Patients With Clinical Response of Cure at Test-of-Cure (TOC) Visit.|The clinical response was assigned by the investigator according to the protocol-specified guidelines. A clinical response of cure was defined as: the test article and the initial intervention (operative and/or radiologically controlled drainage procedure) resolved the intra-abdominal infection.|10-21 days after the last dose of test article|All patients who received ≥1 dose of study drug, who had clinical evidence of complicated intra-abdominal infection, met all inclusion and exclusion criteria, and completed TOC assessment within 8-44 days after last dose of study drug. Patients with an indeterminate assessment were excluded.||participants|||Number
712336|NCT00195403|Secondary|Change From Baseline in Number of Joints With Tenderness, Pain, Limitation of Motion or Swelling at Month 3 and 9|Assessment of 68 joints: joints classified as either tender or not tender, pain or no pain, with limitation of motion or no limitation of motion, swollen or not swollen. An increase from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Baseline, Month 3, 9|Efficacy population included all participants who received >=1 dose of study medication and had the efficacy assessment within 14 days after the final administration. 'N' (number of participants analyzed) = participants who were evaluable for this measure. Data for Month 9 was not analyzed because there were not enough participants for analysis.||joints||Standard Deviation|Mean
712337|NCT00195403|Primary|Change From Baseline in Physician Global Assessment (PGA) of Disease Status at Month 3|PGA of disease activity was measured on a 0 to 10 centimeter (cm) Visual Analog Scale (VAS), with 0 cm = no disease activity and 10 cm = worst disease activity possible.|Baseline, Month 3|Efficacy population included all participants who received >=1 dose of study medication and had the efficacy assessment within 14 days after the final administration.||cm||Standard Deviation|Mean
712338|NCT00195403|Primary|Number of Participants With Adverse Events (AEs)|Any untoward medical occurrence in a participant who received study drug was considered an AE, without regard to possibility of causal relationship. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a serious AE (SAE): death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Unexpected AEs were reported as yes or no at the investigator's determination based on current country product label.|Baseline up to Day 832|Safety population included all participants who received >= 1 dose of study medication and had the safety assessment through appropriate follow-up.||participants|||Number
712339|NCT00195429|Secondary|Creatinine Clearance Rate|Creatinine clearance is a measure of kidney function. Creatinine clearance rate (CCr) is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Creatinine clearance can be measured directly or estimated using established formulas. For this study, CCr was calculated using the Nakivell formula. Normal values for healthy, young males are in the range of 100-135 ml/min and for females, 90-125 ml/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.|12 months|The population that was used for this analysis was patients who completed 12 months.||ml/min||Standard Deviation|Mean
712340|NCT00195429|Primary|Number of Patients With Biopsy Confirmed Acute Rejection at 12 Months Follow up.|Diagnosis of acute rejection was made via kidney biopsy using the Banff criteria (a standardized model for interpretation of renal allograft biopsies).|12 months|The population that was used for this analysis was the transplantation recipient population, which included all randomized patients.||participants|||Number
712341|NCT00195442|Secondary|Number of Participants for Days of Sick Leave Per Month|Days of sick leave (missing work or school) per month categorized as No days of absence, Number of days of absence, Long-term inability to work or study, Not employed or at school, or No specification.|Baseline up to a mean duration of 54 months|Safety population includes all subjects with a baseline visit. N=participants with evaluable data; last measurement available.||participants|||Number
712342|NCT00195442|Secondary|Number of Participants for Patients' Assessment of Handling of ReFacto|Subjective assessment by the participant on handling (preparation and administration) of ReFacto. Patient rated assessment could be categorized as Very good, Good, Moderate, Poor, or No specification; no criteria was pre-specified for the assessment categories in this observational study.|Baseline up to a mean duration of 54 months|Safety population includes all subjects with a baseline visit. N=participants with evaluable data; last measurement available.||participants|||Number
712343|NCT00195442|Secondary|Number of Participants for Physicians' Assessment of Handling of ReFacto|Subjective assessment by the physician to evaluate the participants’ handling (preparation and administration) of ReFacto. Physician rated assessment could be categorized as Very good, Good, Moderate, or Poor; no criteria was pre-specified for the assessment categories in this observational study.|Baseline up to a mean duration of 54 months|Safety population includes all subjects with a baseline visit. N=participants with evaluable data; last measurement available.||participants|||Number
712344|NCT00195442|Secondary|Number of Participants for Patients' Assessment of Tolerance|Subjective assessment by the participant to evaluate tolerance of treatment with ReFacto (i.e., dose, administration method, or adverse effects). Patient rated assessment could be categorized as Very good, Good, Moderate, Poor, or No specification; no criteria was pre-specified for the assessment categories in this observational study.|Baseline up to a mean duration of 54 months|Safety population includes all subjects with a baseline visit. N=participants with evaluable data; last measurement available.||participants|||Number
712345|NCT00195442|Secondary|Number of Participants for Physicians' Assessment of Tolerance|Subjective assessment by the physician to evaluate the participants’ tolerance of treatment with ReFacto (i.e., dose, administration method, or adverse effects). Physician rated assessment could be categorized as Very good, Good, Moderate, or Poor; no criteria was pre-specified for the assessment categories in this observational study.|Baseline up to a mean duration of 54 months|Safety population includes all subjects with a baseline visit. N=participants with evaluable data; last measurement available.||participants|||Number
712346|NCT00195442|Secondary|Number of Participants for Patients' Assessment of Efficacy|Subjective assessment by the participant to evaluate control of bleeding. Patient rated assessment could be categorized as Very good, Good, Moderate, Poor, or No specification; no criteria was pre-specified for the assessment categories in this observational study.|Baseline up to a mean duration of 54 months|Safety population includes all subjects with a baseline visit. N=participants with evaluable data; last measurement available.||participants|||Number
712347|NCT00195442|Secondary|Number of Participants for Physicians' Assessment of Efficacy|Subjective assessment by the physician to evaluate control of bleeding. Physician rated assessment could be categorized as Very good, Good, Moderate, or Poor; no criteria was pre-specified for the assessment categories in this observational study.|Baseline up to a mean duration of 54 months|Safety population includes all subjects with a baseline visit. N=participants with evaluable data; last measurement available.||participants|||Number
712348|NCT00195442|Secondary|Number of Participants for Physicians' Assessment of Satisfaction With Treatment Success|Subjective assessment by the physician to evaluate treatment success (i.e., control of bleeding, Factor VIII consumption, treatment efficacy and tolerance, handling of preparation, and days missing from work or school). Physician rated assessment could be categorized as Very satisfied, Satisfied, Unsatisfied, or Very unsatisfied; no criteria was pre-specified for the assessment categories in this observational study.|Baseline up to a mean duration of 54 months|Safety population includes all subjects with a baseline visit. N=participants with evaluable data; last measurement available.||participants|||Number
712349|NCT00195442|Secondary|Mean Annual ReFacto Consumption Per Patient Year|ReFacto administered as International Units (IU) according to the physician's decision following the drug's summary of product characteristics (SPC) and according to usual care principles.|Baseline up to a mean duration of 54 months|Total population for efficacy analysis included all participants with submitted diary cards and severe haemophilia.||International units per year||Standard Deviation|Mean
712350|NCT00195442|Secondary|Number of Participants With de Novo Inhibitor Formation|The applied criteria of clinical relevance for de novo inhibitor formation was defined as normal Factor VIII dosage was ineffective to control a bleeding, control of bleeding episodes required increasing Factor VIII dosage, change of concentrate type (administration of activated Prothrombin-Complex Concentrate [aPCC] or recombinant Factor VII [rFVII ]) was needed to stop a bleeding, or change of therapy strategy (intensive prophylaxis or Immune Tolerance Induction [ITI]) was required.|Baseline up to a mean duration of 54 months|Safety population includes all subjects with a baseline visit.||participants|||Number
712351|NCT00195442|Secondary|Number of Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs)|AEs are any undesired side effect which occurred in a participant undergoing study treatment independent of whether a correlation with study treatment was suspected or not. SAEs are undesired events which were lethal or life-threatening, made hospitalization or extension of hospital stay necessary, lead to permanent damage with handicap (inability to work), as well as congenital anomalies, malignant disease, or overdosing. Also presence of inhibitors, thrombotic events, erythrocyte agglutination, allergic reactions, less than therapeutic effect, and inhibitor development were considered SAEs.|Baseline up to a mean duration of 54 months|Safety population includes all subjects with a baseline visit; (n)=number of participants with events.||events|||Number
712352|NCT00195442|Primary|Mean Number of Exposure Days Per Patient Year|Exposure days are the number of days of treatment with ReFacto.|Baseline up to a mean duration of 54 months|Total population for efficacy analysis included all participants with submitted diary cards and severe haemophilia.||days per year||Standard Deviation|Mean
712353|NCT00195442|Primary|Mean Number of Bleeding-related Exposure Days Per Patient Year|Exposure days are the number of days of treatment with ReFacto.|Baseline up to a mean duration of 54 months|Total population for efficacy analysis included all participants with submitted diary cards and severe haemophilia.||days per year||Standard Deviation|Mean
712354|NCT00195442|Primary|Mean Number of Bleeding Episodes Per Patient Year|Participants with hemophilia A suffer from a hereditary lack of blood clotting factor VIII. As a consequence, the ability of the blood to coagulate is reduced and bleedings at any site or organ of the body may occur after minor injury or even spontaneously. Predominantly, joints, muscles, and internal organs are affected by bleeding complications. Participants reported the occurrence of each bleeding episode while on study. The bleeding rate for each participant was calculated by number of reported episodes per years on study.|Baseline up to a mean duration of 54 months|Total population for efficacy analysis included all participants with submitted diary cards and severe haemophilia.||episodes per year||Standard Deviation|Mean
712355|NCT00195494|Secondary|Safety Measured by Number of Participants Reporting a Serious Adverse Event That Led to Death|Safety report for entire trial where participants reported a serious adverse event that led to death.|12 and 24 months|The analysis population is the modified intent to treat for year 1 (542 overall baseline participants) and year 2 (411 overall baseline participants).||participants|||Number
712356|NCT00195494|Primary|Year 1 Participants Having an Annualized Modified Total Sharp Score (mTSS) < 0.5.|The (van der Heijde) modified total Sharp score (mTSS) is the sum of scores for erosions (range 0-280) and joint space narrowings (range 0-168) and thus has a total range of (0 - 448 ), where zero is the best score , indicating no damage.|12 months|The analysis population is the modified intent to treat participants from year 1, treatment arms M and E+M.||participants|||Number
712357|NCT00195494|Primary|The Number of Participants Achieving Remission As Measured by a Disease Activity Score for 28 Joints (DAS 28) < 2.6.|Effects of the combination of etanercept and methotrexate to methotrexate alone on clinical disease activity. DAS28 scale 0 - 10, 3.2 or lower showing controlled disease while 5.1 implies active disease.|12 months|The analysis population is the modified intent to treat participants from year 1, treatment arms M and E+M.||participants|||Number
712358|NCT00195507|Secondary|Number of Patients With Survey Response of “Somewhat Satisfied” or Better|Patients completed a patient satisfaction survey at baseline and throughout the study. Patients were asked to rate, based on their experienced during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 7-point scale: Very satisfied, Satisfied, Somewhat Satisfied, Neutral, Somewhat Dissatisfied, Dissatisfied and Very Dissatisfied.|54 weeks|The analysis population was the modified intention-to-treat (mITT) population, which included all patients who received at least one dose of study drug and had at least 1 post-baseline evaluation.||participants|||Number
712388|NCT00200356|Secondary|NIH Stroke Scale Score at 14 Days|The NIH stroke scale is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42(dead). The number of patients with NIH stroke scale score of 0-1 at 14 days after treatment initiation.|14 days|||participants|||Number
712389|NCT00200356|Secondary|Baseline NIH Stroke Scale Score|The NIH stroke scale is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42(dead).|Before treatment initiation|||scores on a scale||Standard Deviation|Mean
712359|NCT00195507|Secondary|Time to Achieve a Physician Global Assessment of Psoriasis Score of “Clear” or “Almost Clear”|Physician Global Assessment of Psoriasis (PGA) is a 7-point scale used to assess severity of psoriatic plaques (1=sever psoriasis, 7=clear). This assessment measured the time (in days) from baseline to the visit where a patient achieved a PGA status of 0 or 1. Patients who did not achieve this status by their last visit were not included.|54 weeks|The analysis population was the modified intention-to-treat (mITT) population, which included all patients who received at least one dose of study drug, had at least 1 post-baseline evaluation and who achieved a PGA status of 0 or 1 by the last visit (Observed cases).||days||95% Confidence Interval|Median
712360|NCT00195507|Secondary|Patient Global Assessment of Psoriasis Score - Percentage of Improvement From Baseline|Patients were asked to rate the severity of their psoriasis disease activity on a 6-point scale, where 0=good and 5=severe.|54 weeks|The analysis population was the modified intention-to-treat (mITT)population, which included all patients who received at least one dose of study drug and had at least 1 post-baseline evaluation. Last observation carried forward (LOCF).||percentage improvement|||Number
712361|NCT00195507|Primary|Physician Global Assessment of Psoriasis (PGA) Score – Mean Value Over 54 Weeks|Physician Global Assessment of Psoriasis (PGA) is a 7-point scale used to assess severity of psoriatic plaques (1=severe psoriasis, 7=clear).|54 weeks|The analysis population was the modified intention-to-treat (mITT)population, which included all patients who received at least one dose of study drug and had at least 1 post-baseline evaluation. Last observation carried forward (LOCF).||units on scale||Standard Deviation|Mean
712362|NCT00199381|Primary|Safety as Measured by Adverse Events|Investigation of the long-term tolerability and safety of istradefylline|Every 2 months up to 32 months|Safety analysis set - all subjects who took at least one dose of study drug. 1 subject of the 504 enrolled did not take study drug and is not included in the safety analysis set.||participants|||Number
712363|NCT00199914|Secondary|Adverse Events||3 weeks||||||
712364|NCT00199914|Secondary|Patient's Satisfaction to the Treatment||3 weeks||||||
712365|NCT00199914|Secondary|Global Improvement||3 weeks||||||
712366|NCT00199914|Secondary|Gait Speed (Calculated From the Time Spending for 100-meter Walk)||3 weeks||||||
712367|NCT00199914|Primary|The Change in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index|The WOMAC index is a multidimensional, self-administered health status evaluation instrument for patients with OA of the hip and knee. It is composed of 24 items that are grouped into three dimensions, including pain (5 items), stiffness (2 items), and function (17 items). The response can be in a form of visual analog or five-point Likert scale [11, 23]. In this study, the response is on a 10-cm horizontal line with numeric description from 0 to 10. The score of each dimension is an average of the component item scores. The WOMAC total score is determined by averaging the scores of all dimensions. The higher score reflects worse pain and stiffness and poorer physical function.|3 weeks|Statistical analyses to test the superiority were based on the intention-to-treat (ITT) population, and those chosen to demonstrate the equivalence were based on the per protocol population. The “worst –case-scenario” was applied to the dropouts in the ITT analyses.||units on a scale||95% Confidence Interval|Mean
712368|NCT00200057|Secondary|Proportion of Subjects With at Least 50% Reduction in Number of Urgent Incontinent Episodes Per Week|"This secondary objective was to demonstrate that at least 50% of subjects achieved at least 50% reduction in the number of urgent incontinent episodes per week at 12 months post-implant compared to baseline. Subjects who achieve at least 50% reduction in the number of urgent fecal incontinent episodes per week at 12 months post-implant compared to baseline are considered successes.
The observed therapeutic success rate is calculated as the proportion of implanted subjects who achieve at least 50% reduction in the number of urgent incontinent episodes per week from baseline to 12 months."|Baseline and 12 months|All subjects who were successfully implanted were included in this analysis. The modified worst-case analysis for missing data was used, so that all subjects with missing 12-month data were classified as failures, unless there was a subsequent diary available, in which case the subsequent diary was substituted for the missing 12-month data.||proportion of subjects||95% Confidence Interval|Mean
712369|NCT00200057|Secondary|Change in Quality of Life From Baseline to 12 Months: Scale 4 - Embarrassment|This secondary efficacy objective was to demonstrate improvement in Fecal Incontinence Quality of Life (FIQOL) scores at 12 months post-implant compared to baseline. Scales range from 1 to 5, with a 1 indicating a lower functional status of quality of life. The four component scales of the FIQOL instrument were evaluated separately.|Baseline and 12 Months|All subjects who were successfully implanted were included in the analysis. The modified worst-case analysis was used to account for subjects who did not complete the FIQOL questionnaire at either baseline or 12 months; these subjects were classified as no change from baseline.||units on a scale||Standard Deviation|Mean
712370|NCT00200057|Secondary|Change in Quality of Life From Baseline to 12 Months: Scale 3 - Depression/Self-Perception|This secondary efficacy objective was to demonstrate improvement in Fecal Incontinence Quality of Life (FIQOL) scores at 12 months post-implant compared to baseline. Scales range from 1 to 5, with a 1 indicating a lower functional status of quality of life. The four component scales of the FIQOL instrument were evaluated separately.|Baseline and 12 Months|All subjects who were successfully implanted were included in the analysis. The modified worst-case analysis was used to account for subjects who did not complete the FIQOL questionnaire at either baseline or 12 months; these subjects were classified as no change from baseline.||units on a scale||Standard Deviation|Mean
712371|NCT00200057|Secondary|Change in Quality of Life From Baseline to 12 Months: Scale 2 - Coping/Behavior|This secondary efficacy objective was to demonstrate improvement in Fecal Incontinence Quality of Life (FIQOL) scores at 12 months post-implant compared to baseline. Scales range from 1 to 5, with a 1 indicating a lower functional status of quality of life. The four component scales of the FIQOL instrument were evaluated separately.|Baseline and 12 Months|All subjects who were successfully implanted were included in the analysis. The modified worst-case analysis was used to account for subjects who did not complete the FIQOL questionnaire at either baseline or 12 months; these subjects were classified as no change from baseline.||units on a scale||Standard Deviation|Mean
712406|NCT00201123|Secondary|Bronchoalveolar Lavage (BAL) to Measure Flow of Cytometry and Cytokine Levels||16 Weeks|Intention to Treat analysis performed. Only subjects excluded were those who did not receive treatment.||cells/mL||Inter-Quartile Range|Median
712407|NCT00201123|Secondary|Chest Cavity Size||16 Weeks|Intention to Treat analysis performed. Only subjects excluded were those who did not receive treatment.||millimeters||Standard Deviation|Mean
712372|NCT00200057|Secondary|Change in Quality of Life From Baseline to 12 Months: Scale 1 - Lifestyle|This secondary efficacy objective was to demonstrate improvement in Fecal Incontinence Quality of Life (FIQOL) scores at 12 months post-implant compared to baseline. Scales range from 1 to 5, with a 1 indicating a lower functional status of quality of life. The four component scales of the FIQOL instrument were evaluated separately.|Baseline and 12 months|All subjects who were successfully implanted were included in the analysis. The modified worst-case analysis was used to account for subjects who did not complete the FIQOL questionnaire at either baseline or 12 months; these subjects were classified as no change from baseline.||units on a scale||Standard Deviation|Mean
712373|NCT00200057|Secondary|Proportion of Subjects With at Least 50% Reduction in Number of Incontinent Days Per Week|"This secondary objective was to demonstrate that at least 50% of subjects achieved at least 50% reduction in the number of incontinent days per week at 12 months post-implant compared to baseline. Subjects who achieve at least 50% reduction in the number of fecal incontinent days per week at 12 months post-implant compared to baseline are considered successes.
The observed therapeutic success rate is calculated as the proportion of implanted subjects who achieve at least 50% reduction in the number of incontinent days per week from baseline to twelve months."|Baseline and 12 months|All subjects who were successfully implanted were included in the analysis. A modified worst-case analysis was used for missing data, where all subjects who were missing 12-month data were classified as failures unless there was a subsequent diary available, in which case the subsequent diary was substituted for the missing 12-month data.||proportion of subjects||95% Confidence Interval|Mean
712374|NCT00200057|Primary|Proportion of Subjects With at Least 50% Reduction in Number of Incontinent Episodes Per Week|"The primary efficacy objective was to demonstrate that at least 50% of subjects will achieve at least 50% reduction in the number of fecal incontinent episodes per week at 12 months post-implant compared to baseline. Subjects who achieve at least 50% reduction in the number of fecal incontinent episodes per week at 12 months post-implant compared to baseline are considered successes.
The observed therapeutic success rate is calculated as the proportion of implanted subjects who achieve at least 50% reduction in the number of incontinent episodes per week from baseline to twelve months."|Baseline and 12 months|All subjects who were successfully implanted were included in the analysis. A modified worst-case analysis was used for missing data, where all subjects who were missing 12-month data were classified as failures, unless there was a subsequent diary available, in which case the subsequent diary was substituted for the missing 12-month data.||proportion of subjects||95% Confidence Interval|Mean
712375|NCT00200343|Secondary|Percentage Change of Gamma-glutamyl Transpeptidase From Baseline at Week 24|Percentage change=[(measured value at Week 24 - measured value at baseline)/measured value at baseline]*100|24 weeks (from baseline to Week 24)|percentage change=[(measured value at Week 24 - measured value at baseline)/measured value at baseline]*100||Percentage of change||Full Range|Median
712376|NCT00200343|Primary|Percentage Change of Alanine Aminotransferase From Baseline at Week 24|Percentage change=[(measured value at Week 24 - measured value at baseline)/measured value at baseline]*100|24 weeks (from baseline to Week 24)|percentage change=[(measured value at Week 24 - measured value at baseline)/measured value at baseline]*100||Percentage of change||Full Range|Median
712377|NCT00200343|Secondary|Gamma-glutamyl Transpeptidase at Baseline||0 week|||IU/L||Standard Deviation|Mean
712378|NCT00200343|Secondary|Percentage Change of Aspartate Aminotransferase From Baseline at Week 24|Percentage change=[(measured value at Week 24 - measured value at baseline)/measured value at baseline]*100|24 weeks (from baseline to Week 24)|||Percentage of change||Full Range|Median
712379|NCT00200343|Secondary|Aspartate Aminotransferase at Baseline||0 week|||IU/L||Standard Deviation|Mean
712380|NCT00200343|Primary|Alanine Aminotransferase at Baseline||0 week|10 patients were excluded from analysis population due to luck of sufficient data.||IU/L||Standard Deviation|Mean
712381|NCT00200356|Secondary|Modified Rankin Scale Score|The number of patients with an Modified Rankin Scale score of 0-1 was evaluated at 6 months after treatment initiation. The Modified Rankin Scale has 6 items, where 0 = No symptoms at all, 1 = No significant disability despite symptoms, 2 = Slight disability, 3 = Moderate disability, 4 = Moderately severe disability, 5 = Severe disability. The higher scores reflect increased disability.|6 months|||participants|||Number
712382|NCT00200356|Secondary|Japan Stroke Scale (Motor Function) Score at 3 Months|The Japan stroke scale (motor function) is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from -0.26 (no deficit) to 31.29 (worst). The mean of Japan stroke scale (motor function) score at 3 months after treatment initiation.|3 months|||units on a scale||Standard Deviation|Mean
712383|NCT00200356|Secondary|Japan Stroke Scale (Motor Function) Score at 1 Month|The Japan stroke scale (motor function) is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from -0.26 (no deficit) to 31.29 (worst). The mean of Japan stroke scale (motor function) score at 1 month after treatment initiation.|1 month|||units on a scale||Standard Deviation|Mean
712384|NCT00200356|Secondary|Japan Stroke Scale (Motor Function) Score at 14 Days|The Japan stroke scale (motor function) is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from -0.26 (no deficit) to 31.29 (worst). The mean of Japan stroke scale (motor function) score at 14 days after treatment initiation.|14 days|||units on a scale||Standard Deviation|Mean
712385|NCT00200356|Secondary|NIH Stroke Scale Score at 3 Months|The NIH stroke scale is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42(dead). The number of patients with NIH stroke scale score of 0-1 at 3 months after treatment initiation.|3 months|||participants|||Number
712386|NCT00200356|Primary|the Rate of Patients With a Modified Rankin Scale Score of 0-1|The number of patients with mRS score of 0-1 (good outcome) at 3 months after treatment initiation. The mRS has 6 items, where 0 = No symptoms at all, 1 = No significant disability despite symptoms, 2 = Slight disability, 3 = Moderate disability, 4 = Moderately severe disability, 5 = Severe disability. The higher scores reflect increased disability.|3 months|||participants|||Number
712387|NCT00200356|Secondary|NIH Stroke Scale Score at 1 Month|The NIH stroke scale is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42(dead). The number of patients with NIH stroke scale score of 0-1 at 1 month after treatment initiation.|1 month|||participants|||Number
712390|NCT00200356|Secondary|Barthel Index Score|"The Barthel Index of Activities of Daily Living measures functional disability by quantifying patient performance in 10 activities of daily life. These activities can be grouped according to self-care (feeding, grooming, bathing, dressing, bowel and bladder care, and toilet use) and mobility (ambulation, transfers, and stair climbing). 5-point increments are used in scoring, with a maximal score of 100 indicating that a patient is fully independent in physical functioning, and a lowest score of 0 representing a totally dependent bed-ridden state.
The number of patients with 95-100 Barthel Index was evaluated at at 3 months after treatment initiation."|3 months|||participants|||Number
712391|NCT00200785|Secondary|Electrical Impedance in Ohms|Electrical impedance (ohms) was measured using 0.5 mL of whole blood plus 0.5 mL saline in a Chronolog Whole Blood aggregometer. Ten mL of whole blood were collected and tested every week. There is no mathematical correlation between impedance (ohms) and percent aggregation.|4 weeks|"Nine persons participated in the high allicin test. Six of the same persons participated in the no allicin test."||ohms||Standard Deviation|Mean
712392|NCT00200785|Primary|Percent Platelet Aggregation|percent platelet aggregation in collagen-induced platelet aggregation in platelet rich plasma (PRP)|4 weeks|||percent platelet aggregation||Standard Deviation|Mean
712393|NCT00200967|Secondary|Asthma Control Questionnaire (ACQ)|Change between placebo salmeterol and active salmeterol for ACQ, where ACQ ranges from 0 (best asthma control) to 6 (worst asthma control).|Clinic visits at weeks 0 and 18 of each treatment period|An ITT paradigm was invoked in which the available data (without any imputation for missing data) on all randomized participants were included.||units on a scale||95% Confidence Interval|Least Squares Mean
712394|NCT00200967|Secondary|Methacholine Provocative Concentration 20 (PC20)|Change between placebo salmeterol and active salmeterol for methacholine PC20|Clinic visits at weeks 0 and 18 of each treatment period|An ITT paradigm was invoked in which the available data (without any imputation for missing data) on all randomized participants were included.||milligrams per milliliter||95% Confidence Interval|Geometric Mean
712395|NCT00200967|Secondary|Exhaled Breath Condensate (EBC)|Change between placebo salmeterol and active salmeterol for EBC|Clinic visits at weeks 0, 10, and 18 of each treatment period|An ITT paradigm was invoked in which the available data (without any imputation for missing data) on all randomized participants were included.||pH||95% Confidence Interval|Least Squares Mean
712396|NCT00200967|Secondary|Exhaled Nitric Oxide (eNO)|Change between placebo salmeterol and active salmeterol for eNO|Clinic visits at weeks 0, 2, 6, 10, 14, and 18 of each treatment period|An ITT paradigm was invoked in which the available data (without any imputation for missing data) on all randomized participants were included.||parts per billion||95% Confidence Interval|Geometric Mean
712397|NCT00200967|Secondary|Spirometry Peak Expiratory Flow (PEF) Rate, Pre-bronchodilator|Change between placebo salmeterol and active salmeterol for Spirometry PEF rate, pre-bronchodilator|Clinic visits at weeks 0, 2, 6, 10, 14, and 18 of each treatment period|An ITT paradigm was invoked in which the available data (without any imputation for missing data) on all randomized participants were included.||liters per minute||95% Confidence Interval|Least Squares Mean
712398|NCT00200967|Secondary|Spirometry Forced Vital Capacity (FVC), Pre-bronchodilator|Change between placebo salmeterol and active salmeterol for Spirometry FVC, pre-bronchodilator|Clinic visits at weeks 0, 2, 6, 10, 14, and 18 of each treatment period|An ITT paradigm was invoked in which the available data (without any imputation for missing data) on all randomized participants were included.||liters||95% Confidence Interval|Least Squares Mean
712399|NCT00200967|Secondary|Spirometry Forced Expiratory Volume in One Second (FEV1), Pre-bronchodilator|Change between placebo salmeterol and active salmeterol for Spirometry FEV1, pre-bronchodilator|Clinic visits at weeks 0, 2, 6, 10, 14, and 18 of each treatment period|An ITT paradigm was invoked in which the available data (without any imputation for missing data) on all randomized participants were included.||liters||95% Confidence Interval|Least Squares Mean
712400|NCT00200967|Secondary|Rescue Medication (Ipratropium and Albuterol) Use|Change between placebo salmeterol and active salmeterol for rescue medication use|Recorded daily on a diary card, and then averaged between weeks 0, 2, 6, 10, 14, and 18 of each treatment period|An ITT paradigm was invoked in which the available data (without any imputation for missing data) on all randomized participants were included.||puffs per day||95% Confidence Interval|Mean
712401|NCT00200967|Secondary|Asthma Symptoms|Change between placebo salmeterol and active salmeterol for asthma symptoms (0=absent, 1=mild, 2=moderate, 3=severe).|Recorded daily on a diary card, and then averaged between weeks 0, 2, 6, 10, 14, and 18 of each treatment period|An ITT paradigm was invoked in which the available data (without any imputation for missing data) on all randomized participants were included.||units on a scale||95% Confidence Interval|Mean
712402|NCT00200967|Secondary|Peak Expiratory Flow (PEF) Variability|Change between placebo salmeterol and active salmeterol for PEF variability, where PEF variability is defined as 100% x (PM PEF - AM PEF)/(PM PEF)|Measured daily using a hand-held peak flow meter, and then averaged between weeks 0, 2, 6, 10, 14, and 18 of each treatment period|An ITT paradigm was invoked in which the available data (without any imputation for missing data) on all randomized participants were included.||percentage||95% Confidence Interval|Least Squares Mean
712403|NCT00200967|Secondary|Evening (PM) Peak Expiratory Flow (PEF) Rate|Change between placebo salmeterol and active salmeterol for PM PEF rate|Measured daily using a hand-held peak flow meter, and then averaged between weeks 0, 2, 6, 10, 14, and 18 of each treatment period|An ITT paradigm was invoked in which the available data (without any imputation for missing data) on all randomized participants were included.||liters per minute||95% Confidence Interval|Least Squares Mean
712404|NCT00200967|Primary|Morning (AM) Peak Expiratory Flow (PEF) Rate|Change between placebo salmeterol and active salmeterol for AM PEF rate|Measured daily using a hand-held peak flow meter, and then averaged between weeks 0, 2, 6, 10, 14, and 18 of each treatment period|An intention-to-treat (ITT) paradigm was invoked in which the available data (without any imputation for missing data) on all randomized participants were included.||liters per minute||95% Confidence Interval|Least Squares Mean
712405|NCT00201006|Primary|Change in Body Weight.|Change in body weight during the 12-month period following completion of a 6-month lifestyle treatment for obesity.|one year|Data from all randomized participants were analyzed according to the Intent to Treatment principle. Missing data (6%) were completed based on known pattern of weight regain (i.e., 0.3 kg per month).||kg||Standard Error|Mean
712742|NCT00197392|Secondary|Days to Proven Infection|Number of days to proven infection.|Implantation of EVD System to explant of EVD catheter, an average of ten days|||Days||Standard Deviation|Mean
712409|NCT00201201|Secondary|Satisfaction With the APRN Provider Relationship|The Healthcare Relationships Scale assesses the perceived communication relationship with a provider. The 5-item instrument, based on two qualitative studies addresses patient-provider communication (2 questions), trust, decision-making related to care, and satisfaction with care. The scale was modified for use with older adults by changing the visual analog 10 cm response format to 5-point Likert-type responses with two extremes (e.g., 1:“not at all easy” to 5: “very easy”).|Measured at 0, 12 weeks on visit 1 and 4|There 69 participants in the control group and 82 participants in the education intervention group who chose to complete the satisfaction with the APRN provider on visit one and 65 in the control group and 75 in the education intervention group who chose to complete the survey on visit 4.||units on a scale of 1-5||Standard Deviation|Mean
712410|NCT00201201|Secondary|Satisfaction With the PEP-NG|"The PEP-NG user Satisfaction scale is a 14-item instrument – with eight items addressing the ease of program use, program content, and suitability of program content – and another six items addressing the intent to change behavior following program use. Ratings reflected by the 5-point Likert-type scale (ranging from 1, strongly disagree to 5, strongly agree) were summed and divided by the number of items answered to ensure that the overall Satisfaction scale was not affected by omitted items and was cast in the original 5-point metric. The higher the score on the instrument, the higher the degree of satisfaction with the PEP-NG."|Measured at 12 weeks|||units on a scale||Standard Deviation|Mean
712411|NCT00201201|Secondary|Prescription/Over the Counter (Rx-OTC) Knowledge|The OTC-Rx Knowledge scale has 14 multiple-choice items and the score is the percent of the items with correct response (range: 0-100%; these items test both knowledge and application concerning potential adverse effects of self-medication with OTC agents, supplements, or alcohol in persons with hypertension. The higher the score, the higher the knowledge of the potential adverse effects from self-medication.|Measured at 0, 4, 8, 12 weeks on visits 1, 2, 3 and 4|||percentage of questions correct||Standard Deviation|Mean
712412|NCT00201201|Secondary|Self-efficacy for Avoiding Adverse Self-medication Behaviors|"The Self-efficacy scale is a 12-item instrument with statements reflecting patient confidence in selecting appropriate OTC agents and supplements, aside from avoiding adverse effects arising from self-medication behaviors. This scale has 5-point self-report response categories (ranging from 1, Not Sure to 5, Totally Sure). Responses were summed and divided by the number of items answered, so that the overall score would not be affected by omitted items and was reported based on the original 5-point metric. The higher the score on the instrument, the higher the degree of self-efficacy for avoiding adverse self-medication behaviors."|Measured at 0, 4, 8 and 12 weeks on visit 1, 2, 3 and 4|||units on a scale||Standard Deviation|Mean
712413|NCT00201201|Primary|Blood Pressure (BP) Readings: Systolic Blood Pressure|BP measurements were taken by the APRN at each of 4 visits – at the beginning of PEP-NG use on visit 1, and post-PEP-NG use on subsequent visits.|Measured at weeks 0, 4, 8 and 12 on visit 1, 2, 3 and 4|||mm Hg||Standard Deviation|Mean
712414|NCT00201201|Primary|Behaviors Risk Score|"Using a five-point scale from 1, very unlikely to 5, very likely, a five-member expert panel rated a list of adverse self-medication behaviors. The weight of each behavior was the mean of the expert ratings. Adverse self-medication behaviors were identified from questions that address use of medications (in the past month) to treat high blood pressure as well as use of OTC agents and alcohol for common problems that were self-treated with non-prescription agents. Participants were also asked if they drank alcoholic beverages, smoked or used nicotine, or took any vitamin or mineral supplements (including what, when and how frequently each was taken). The Adverse Self-Medication Behavior Risk Score is the sum (range 3 - 60) of the scores for the adverse behaviors identified. The higher the score, the higher the risk is for adverse self-medication behaviors."|Measured at 0, 4, 8, and 12 weeks on visit 1, 2, 3 and 4|||units on a scale||Standard Deviation|Mean
712415|NCT00201240|Secondary|Post-transplant Lymphoproliferative Disorder (PTLD)|PTLD is defined as increased Epstein Barr Virus viremia requiring clinical intervention.|Year 2|||participants|||Number
712416|NCT00201240|Secondary|CD34+ and CD3+ Cell Doses|Total CD34+ and CD3+ cell doses will be calculated based on results of flow cytometric analysis.|Day 0|||cells per kilogram||Full Range|Median
712417|NCT00201240|Secondary|Overall Survival|Overall survival is defined as time from transplant to death or last follow-up.|Months 12 and 36|||percentage of participants||95% Confidence Interval|Number
712418|NCT00201240|Secondary|Disease-free Survival (DFS)|DFS is defined as the minimum time interval of times to relapse/recurrence, to death or to the last follow-up, from the time of transplant.|Months 6, 12, and 36|||percentage of participants||95% Confidence Interval|Number
712419|NCT00201240|Secondary|Determination of Infusional Toxicity||28 day|No data collected|||||
712420|NCT00201240|Secondary|Transplant Related Mortality|Death occurring in a patient in continuing complete remission.|Months 12, 24, and 36|||percentage of participants||95% Confidence Interval|Number
712421|NCT00201240|Secondary|Chronic Graft Versus Host Disease (GVHD)|Incidence and severity of chronic GVHD will be scored according to the BMT CTN MOP.|Year 2|||percentage of participants||95% Confidence Interval|Number
712422|NCT00201240|Secondary|Acute Graft Versus Host Disease (GVHD)|Incidence and severity of acute GVHD will be graded according to the BMT CTN MOP.|Day 100|||percentage of participants||95% Confidence Interval|Number
712423|NCT00201240|Secondary|Graft Failure|Primary graft failure is defined as the failure to achieve an ANC > 500 cells/µL by Day +30. Secondary graft failure is defined as initial neutrophil engraftment followed by subsequent decline in neutrophil counts < 500 cells/µL, unresponsive to growth factor therapy.|Day 100|||participants|||Number
712424|NCT00201240|Secondary|Platelet Engraftment|Time to platelet engraftment is measured by determining the first of three consecutive measurements of platelet count ≥ 20,000/uL without platelet transfusion support for seven days, starting from Day 0.|6 Months|||days||Full Range|Median
712425|NCT00201240|Secondary|Neutrophil Engraftment|Time to neutrophil engraftment is measured by determining the first of three consecutive measurements of absolute neutrophil count ≥ 500/uL following conditioning regimen induced nadir, starting from Day 0.|28 day|||days||Full Range|Median
712426|NCT00201240|Secondary|Leukemia Relapse|To assess the incidence of acute leukemia relapse from day of transplant, a cumulative incidence curve will be computed along with a 95% confidence interval. Death prior to relapse will be considered as a competing risk.|Months 12 and 36|||percentage of participants||95% Confidence Interval|Number
712427|NCT00201240|Primary|Probability of Disease-free Survival (DFS) at 6 Months Post-transplant (Death or Relapse Will be Considered Events for This Endpoint)|The primary analysis will consist of estimating the 6-month DFS (from day of enrollment) probability based on the Kaplan-Meier product limit estimator. The 6-month DFS probability and confidence interval will be calculated. All registered patients will be considered for this analysis.|6 months|All transplanted patients||percentage of patients||95% Confidence Interval|Number
712428|NCT00201409|Secondary|Days Without Organ Failure|Non-respiratory|Measured at Day 28|||days||Standard Deviation|Mean
712429|NCT00201409|Secondary|Oxygenation Index Change at Day 15 From Day 1|The oxygenation index is a calculation used in intensive care medicine to measure the fraction of inspired oxygen (FiO2) and its usage within the body. It is calculated as the fraction of inspired oxygen times Mean airway pressure)/Partial pressure of oxygen in arterial blood Day 15 minus first day drug or placebo administered (Day 1).|Day 1, Day 15|||oxygenation index||Standard Deviation|Mean
712430|NCT00201409|Primary|Ventilator-free Days During Days 1-28||Measured at Day 28|||Days||Standard Deviation|Mean
712431|NCT00186875|Other Pre-specified|Minimal Residual Disease (MRD) Compared With Historical Data From TOTXV Protocol (NCT00137111)|The prevalence of MRD in children undergoing treatment for relapsed ALL and to compare the results to those obtained in children with newly diagnosed ALL. MRD is considered as positive (i.e., prevalent) if its level is >=0.01%. The prevalence of MRD after Block B is defined as the proportion of MRD positives.|End of Block B therapy (Day 19)|Protocol information for the comparison group of TOTXV Participants, including Participant Flow, Baseline Characteristics, and Adverse Events, is available on ClinicalTrials.gov under registration ID NCT00137111.||Participants|||Count of Participants
712432|NCT00186875|Other Pre-specified|Minimal Residual Disease (MRD) Compared With Historical Data From TOTXV Protocol (NCT00137111)|The prevalence of MRD in children undergoing treatment for relapsed ALL and to compare the results to those obtained in children with newly diagnosed ALL. MRD is considered as positive (i.e., prevalent) if its level is >=0.01%. The prevalence of MRD after Block C is defined as the proportion of MRD positives.|End of Block Block C therapy (Day 46)|Protocol information for the comparison group of TOTXV Participants, including Participant Flow, Baseline Characteristics, and Adverse Events, is available on ClinicalTrials.gov under registration ID NCT00137111.||Participants|||Count of Participants
712433|NCT00186875|Primary|Overall Survival (OS)|OS is measured from the start of on-study to the date of death or to the last date of follow-up. Measurement is determined by Kaplan-Meyer estimate. The probability of survival at 5 years after diagnosis is given.|2 years after last patient completes therapy (approximately 4 years after enrollment)|||probability||Standard Deviation|Mean
712434|NCT00186875|Primary|Response Rate|"The response rate is defined as the proportion of participants who attain morphological complete remission after the re-induction Block C, inclusive of all patients who begin re-induction. Morphological complete remission was defined as <5% blasts in bone marrow by morphology."|End of re-induction Block C (approximately 1 month after the start of therapy)|Response is defined as morphological complete remission after re-induction Block C. Participants who begin re-induction phase but fail to reach the end of Block C for whatever reason will be regarded as an induction failure.||proportion of participants|||Number
712435|NCT00186888|Secondary|Assessment of School Readiness|The Bracken Basic Concepts Scale was used to assess school readiness. It is an examiner-administered measure that assesses per-academic skills including letter and number recognition, shapes, colors, and understanding of sizes and comparisons. Raw scores are converted into age-normed scaled scores (normative mean = 10, SD = 3) for the School Readiness Composite. Higher scores are indicative of stronger pre-academic skills, with scores from 7 to 13 within the Average range.|Patients were assessed at 5 years of age|All patients were included, regardless of treatment strata.||units on a scale||Standard Deviation|Mean
712436|NCT00186888|Secondary|Change in Parenting Stress Index (PSI)|The PSI is a commonly used measure of parenting stress. In 101 questions, the PSI delineates between stress as a function of child characteristics (e.g., adaptability, demandingness, mood; Child Domain) and stress as a function of parent characteristics (e.g., depression, sense of competence, social isolation; Parent Domain), as well as an overall stress score (Total Stress). Raw scores are calculated (normative means: Child Doman = 98.4; Parent Domain = 122.7; Total Stress Score = 221.1). This measure was given at all time points. Scores range from 131-320 for Total Stress, 69-188 for Parent Domain, and 50-145 for Child Domain, with higher scores indicative of greater stress (Total: >260; Parent: >153, Child: >122).|Baseline (at study entry), 6 months, 1 year, 2 years, 3 years, and 5 years|Data was collected from 94 unique patients. All patients were included, regardless of treatment strata. If the patient age at study entry (baseline) was within the window of an identified time point, their information was included with that time point.||units on a scale||Standard Deviation|Mean
712437|NCT00186888|Secondary|Change in Parent Report of Social-Emotional Factors|This outcome was measured using the Ages and Stages Questionnaire which is a parent-completed measure of a child's social-emotional functioning. Raw scores are calculated and compared to cut-off points by age (6 months = 45; 1 year = 48; 2 years = 50; 3 years = 59; 5 years =70). Higher scores are indicative of more problems with scores above the cut-off indicating significant concerns warranting additional follow-up. Possible scores range from 0 to 200+, depending on the number of items administered, which varies by the age of the child (19 to 33 items). However, the primary use of this tool is as a screener. Thus, typically, scores are interpreted as they compare to the identified cut-offs, with children who score above the cut-off referred for further evaluation. This measure was given at all time points.|Baseline (at study entry), 6 months, 1 year, 2 years, 3 years, and 5 years|Data was collected from 94 unique patients. All patients were included, regardless of treatment strata. If the patient age at study entry (baseline) was within the window of an identified time point, their information was included with that time point.||units on a scale||Standard Deviation|Mean
712462|NCT00186901|Secondary|Mean QCT Z-Score by Apa1 Vitamin D Receptor Genotype|The Apa1 Vitamin D Receptor has been associated with bone mineral density and bone turnover markers in various patient cohorts but has not been investigated I survivors of childhood|At enrollment|Of the 424 patients screened, 417 participants consented for genetic testing. Of the 417 patients screened for the Apa 1 vitamin D receptor, only 68 had the AA genotype, 104 had the Aa genotype, and 49 had the aa genotype.||QCT Z-Score||Standard Deviation|Mean
712743|NCT00197392|Primary|Number of Infections|The number of infections for the Codman Bactiseal EVD Catheter and the number of infections for a Standard EVD Catheter (ventriculostomy-related infections).|Duration of implanted EVD system to 2 week post implant|||Infections|||Number
712438|NCT00186888|Post-Hoc|Number of Patients Recommended for and Utilizing Rehabilitation Services|"Participants were evaluated by Occupational Therapy at diagnosis, and at 3, 6, 9, and 12 months from diagnosis with a battery of standardized and non-standardized measures. Assessments including the Battelle Developmental Inventory, the Sensory Profile, the Oregon Project for Visually Impaired Preschoolers, Pediatric Evaluation of Disability Inventory, and the Greenspan Social Emotional Growth Scale were utilized for developing the participants plan of care and making referrals for services in the home community. Recommendations for rehabilitation services in the home community were made based on the results of the occupational therapists evaluation.
A subsequent review of February 2013 subgroup definitions resulted in the reclassification of evaluable participants and subgroups in May 2015. This reclassification applies to the data for this outcome only."|At diagnosis, and at 3, 6, 9, and 12 months from diagnosis|Objective was added after the protocol started. Due to the late start, 33 of the 105 overall participants were eligible. Of the 33, 1 family declined to participate; 1 was removed from the protocol, 5 were lost to follow-up, and 4 patients were unable to complete the developmental assessment. In total, 22 have complete data sets.||participants|||Number
712439|NCT00186888|Secondary|Change in Relevant Daily Living Skills|The Adaptive Behavior composite was measured using the Vineland Scales of Adaptive Behavior (VABS) which is an examiner-administered semi-structured interview that assesses adaptive functioning from birth through adulthood. Subscales including motor skills, communication, socialization, and daily living skills combine into an overall adaptive behavior composite which is an age-normed standard score (normative mean = 100, SD = 15). This measure was given at all time points. Higher scores are indicative of better functioning, with scores from 85-115 in the average range.|Baseline (at study entry), 6 months, 1 year, 2 years, 3 years, and 5 years|Data was collected from 94 unique patients. All patients were included, regardless of treatment strata. If the patient age at study entry (baseline) was within the window of an identified time point, their information was included with that time point.||units on a scale||Standard Deviation|Mean
712440|NCT00186888|Secondary|Change in Cognitive Functioning|The Early Learning Composite was assessed with Mullen Scales of Early Learning, a measure of developmental functioning appropriate for use with children from birth through age 5. It is an examiner-administered instrument that uses toys, games, pictures, and other objects to elicit information about a child's language, fine and gross motor skills, and overall early learning capabilities. Raw scores are converted to an age-normed standard score (normative mean = 100, SD = 15) for the overall Early Learning Composite. This measure was given at all time points. Higher scores are indicative of better functioning, with scores from 85-115 in the average range.|Baseline (at study entry) and at ages 6 months, 1 year, 2 years, 3 years and 5 years|Data was collected from 94 unique patients. All patients were included, regardless of treatment strata. If the patient age at study entry (baseline) was within the window of an identified time point, their information was included with that time point.||units on a scale||Standard Deviation|Mean
712441|NCT00186888|Secondary|Ocular Survival Per Eye in Stratum A and Stratum B Patients Based on AJCC Classification|"To describe the 5-year ocular survival of eyes outcome of intraocular retinoblastoma with respect to the new classification of the American Joint Committee on Cancer (AJCC).
For AJCC staging, the patients were classified into 2 groups of early (AJCC=1, 1a or 1b) and advanced (AJCC=2, 2a, 2b, 3, 3a, 3b) retinoblastoma . The analysis was done at eye level since each eye in the same patient could be a different group. Patients from stratum A and B were analyzed separately"|From date on-study to an event or last follow-up|For the 23 stratum A patients, 35 eyes (12 bilateral patients, 11 unilateral patients) with IC grouping were analyzed. For 26 Stratum B patients, 1 eye with up-front surgery was excluded from analysis. Participants with bilateral disease may have one eye in each category.||probability|Number of Eyes|95% Confidence Interval|Number
712442|NCT00186888|Secondary|Event-free Survival Per Eye in Stratum A and Stratum B Patients Based on AJCC Classification|"To describe the 5-year event-free survival of eyes outcome of intraocular retinoblastoma with respect to the new classification of the American Joint Committee on Cancer (AJCC).
For AJCC staging, the patients were re-classified into 2 groups of early (AJCC=1, 1a or 1b) and advanced (AJCC=2, 2a, 2b, 3, 3a, 3b) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group. Patients from stratum A and B were analyzed separately"|From date on-study to an event or last follow-up|For the 23 stratum A patients, 35 eyes (12 bilateral patients, 11 unilateral patients) with IC grouping were analyzed. For 26 Stratum B patients, 1 eye with up-front surgery was excluded from analysis. Participants with bilateral disease may have one eye in each category.||probability|Eyes|95% Confidence Interval|Number
712443|NCT00186888|Secondary|Ocular Survival of Eyes in Stratum A and Stratum B Patients Based on IC Classification|"To describe the 5-year ocular survival of eyes outcome of intraocular retinoblastoma with respect to the new International Classification (IC) for Intraocular Retinoblastoma and the AJCC.
Patients were re-classified into 2 groups of early (IC groups A and B) and advanced (IC groups C, D, and E) retinoblastoma. Analysis was done at eye level since each eye in the same patient could be a different group. Patients from stratum A and B were analyzed separately.
Three eyes (2 patients) in stratum B received external beam radiation therapy (EBRT) and were also coincident with enucleation surgery, so their event status was not changed. Although the 3 eyes had shorter EFS interval because EBRT occurred (less than 2 years) before the surgery, it did not change the 5-year survival probability."|From date on-study to an event or last follow-up|For the 23 stratum A patients, 35 eyes (12 bilateral patients, 11 unilateral patients) with IC grouping were analyzed.For 26 Stratum B patients, 1 eye with up-front surgery was excluded from analysis. 51 eyes with IC grouping were analyzed. Participants with bilateral disease may have one eye in each category.||probability|Eyes|95% Confidence Interval|Number
712460|NCT00186888|Primary|Stratum B Response to Window Therapy|The primary outcome is to estimate the proportion of stratum B patients responding to 2 courses of window therapy consisting of vincristine and topotecan. Complete Response is the complete regression of all apparent tumor masses in the funduscopic examination and by MRI and ultrasound (US). Partial Response is defined as greater than 50% (but less than 100%) reduction of the tumor masses in the funduscopic examination and by US and MRI, without the appearance of any new lesions. The response must persist for at least 4 weeks. Stratum A and C did not receive window therapy.|Six weeks post window therapy|The primary objective related to stratum B patients only, as these were the patients who were given window therapy consisting of 2 courses of vincristine and topotecan. Of the 27 stratum B patients enrolled, all were included in the analysis of the primary objective.||Participants|||Number
712744|NCT00197496|Secondary|Lower Extremity Functional Scale||discharge|||units on a scale||Standard Deviation|Mean
712444|NCT00186888|Secondary|Event-free Survival of Eyes in Stratum A and Stratum B Patients Based on IC Classification|"To describe the 5-year event-free survival of the eyes outcome of intraocular retinoblastoma with respect to the new International Classification (IC) for Intraocular Retinoblastoma and the AJCC.
Patients were re-classified into 2 groups of early (IC groups A and B) and advanced (IC groups C, D, and E) retinoblastoma. Analysis was done at eye level since each eye in the same patient could be a different group. Patients from stratum A and B were analyzed separately.
Three eyes (2 patients) in stratum B received external beam radiation therapy (EBRT) and were also coincident with enucleation surgery, so their event status was not changed. Although the 3 eyes had shorter EFS interval because EBRT occurred (less than 2 years) before the surgery, it did not change the 5-year survival probability."|From date on-study to an event or last follow-up|For the 23 stratum A patients, 35 eyes (12 bilateral patients, 11 unilateral patients) with IC grouping were analyzed. For 26 Stratum B patients, 1 eye with up-front surgery was excluded from analysis. 51 eyes with IC grouping were analyzed. Participants with bilateral disease may have one eye in each category.||probability|Number of Eyes|95% Confidence Interval|Number
712445|NCT00186888|Secondary|Ocular Survival of Eyes of Stratum B Patients|"To estimate the 5-year ocular survival of early stage eyes (R-E I-III) of patients with contralateral advanced disease treated with vincristine and topotecan.
Ocular survival will be defined per patient as follows: for patients with one advanced stage eye, the time interval from date on study to date of enucleation of advanced stage eye or date of last follow-up, for patients with two advanced stage eyes, the time to the first enucleation will be used for analysis. Ocular survival will be estimated using the method of Kaplan and Meier."|From date on-study to an event or last follow-up|The criteria considered eyes of all stratum B patients with R-E I-III (11 eyes in 11 patients).||probability|Eyes|95% Confidence Interval|Number
712446|NCT00186888|Secondary|Event-free Survival of Eyes of Stratum B Patients|"To estimate the 5-year event-free survival of early stage eyes (R-E I-III) of patients with contralateral advanced disease treated with vincristine and topotecan.
Event-free survival of eye will be defined per eye as the time interval from date on study to date of first event (an event includes external beam radiation or enucleation) or to last follow-up date for eyes without events. Event-free survival of eye will be estimated using the method of Kaplan and Meier."|From date on-study to an event or last follow-up|The criteria considered eyes of all stratum B patients with R-E I-III (11 eyes in 11 patients).||probability|Eyes|95% Confidence Interval|Number
712447|NCT00186888|Secondary|Ocular Survival of Stratum A Patients|"To estimate the 5-year ocular survival of patients with early stage intraocular retinoblastoma (R-E I-III) with vincristine and carboplatin with intensive focal treatments.
Ocular survival will be defined per patient as follows: for patients with one advanced stage eye, the time interval from date on study to date of enucleation of advanced stage eye or date of last follow-up, for patients with two advanced stage eyes, the time to the first enucleation will be used for analysis. Ocular survival will be estimated using the method of Kaplan and Meier."|From date on-study to an event or last follow-up|All 23 stratum A patients received VC treatment and focal therapy.||probability||95% Confidence Interval|Number
712448|NCT00186888|Secondary|Event-free Survival of Stratum A Patients|"To estimate the 5-year event-free survival of patients with early stage intraocular retinoblastoma (R-E I-III) with vincristine and carboplatin with intensive focal treatments.
Event-free survival will be defined per patient as follows: for patients with one advanced stage eye, the time interval from date on study to date of first event (an event includes external beam radiation or enucleation) of advanced stage eyes, time to first event will be used for the analysis. Event-free survival will be estimated using the method of Kaplan and Meier."|From date on-study to an event or last follow-up|All 23 stratum A patients received VC treatment and focal therapy.||probability||95% Confidence Interval|Number
712449|NCT00186888|Secondary|Ocular Survival of Eyes in Stratum B Patients Not Responding to Window Treatment|To estimate the 5-year ocular survival of the eye of patients with advanced intraocular retinoblastoma (R-E IV-V) not responding to the vincristine/topotecan window, with a combination of vincristine, carboplatin, etoposide, and periocular carboplatin, with intensive focal treatments|From date on-study to an event or last follow-up|The study closed to enrollment early due to poor accrual, but it remains open to follow-up. Both patients who developed new lesions in one eye during window therapy had a good response in the contralateral eye, and they continued on protocol therapy with vincristine/topotecan. Therefore, no patients were treated with this combination therapy.|||||
712450|NCT00186888|Secondary|Event-free Survival of Eyes in Stratum B Patients Not Responding to Window Treatment|To estimate the 5-year event free survival of the eye of patients with advanced intraocular retinoblastoma (R-E IV-V) not responding to the vincristine/topotecan window, with a combination of vincristine, carboplatin, etoposide, and periocular carboplatin, with intensive focal treatments|From date on-study to an event or last follow-up|The study closed to enrollment early due to poor accrual, but it remains open to follow-up. Both patients who developed new lesions in one eye during window therapy had a good response in the contralateral eye, and they continued on protocol therapy with vincristine/topotecan. Therefore, no patients were treated with this combination therapy.|||||
712451|NCT00186888|Secondary|Ocular Survival of Stratum B Patients Not Responding to Window Treatment|To estimate the 5-year ocular survival of patients with advanced intraocular retinoblastoma (R-E IV-V) not responding to the vincristine/topotecan window, with a combination of vincristine, carboplatin, etoposide, and periocular carboplatin, with intensive focal treatments.|From date on-study to an event or last follow-up|The study closed to enrollment early due to poor accrual, but it remains open to follow-up. Both patients who developed new lesions in one eye during window therapy had a good response in the contralateral eye, and they continued on protocol therapy with vincristine/topotecan. Therefore, no patients were treated with this combination therapy.|||||
712452|NCT00186888|Secondary|Event-free Survival of Stratum B Patients Not Responding to Window Treatment|To estimate the 5-year event free survival of patients with advanced intraocular retinoblastoma (R-E IV-V) not responding to the vincristine/topotecan window, with a combination of vincristine, carboplatin, etoposide, and periocular carboplatin, with intensive focal treatments.|From date on-study to an event or last follow-up|The study closed to enrollment early due to poor accrual, but it remains open to follow-up. Both patients who developed new lesions in one eye during window therapy had a good response in the contralateral eye, and they continued on protocol therapy with vincristine/topotecan. Therefore, no patients were treated with this combination therapy.|||||
712745|NCT00197496|Secondary|2 Minute Walk Test||discharge|||metres||Standard Deviation|Mean
712453|NCT00186888|Secondary|Ocular Survival of Eyes in Stratum B Patients Responding to Window Treatment|"To estimate the 5-year ocular survival of eye of bilateral disease patients with advanced intraocular retinoblastoma in either eye (R-E IV-V) responding to the vincristine/topotecan window, with alternating cycles of vincristine and carboplatin with vincristine, topotecan, and periocular carboplatin, with intensive focal treatments.
Ocular survival of eye will be defined per eye as the time interval from date on study to date of enucleation or date of last follow-up. Ocular survival of eye will be estimated using the method of Kaplan and Meier. Standard error is 5-year ocular survival."|From date on-study to an event or last follow-up|Of the 52 eyes (26 evaluable patients), 2 eyes (2 patients) were removed from analysis as they were not responsive to window therapy. In both cases, the contralateral eye was included in the analysis. One patient with upfront enucleation had only one eye for analysis. Eleven eyes were R-E Group I-III and were excluded. Total: 38 eyes for analysis.||probability|Eyes|95% Confidence Interval|Number
712454|NCT00186888|Secondary|Event-free Survival of Eyes in Stratum B Patients Responding to Window Treatment|"To estimate the 5-year event-free survival (EFS) of eyes of bilateral disease patients with advanced intraocular retinoblastoma in either eye (R-E IV-V) responding to the vincristine/topotecan window, with alternating cycles of vincristine and carboplatin with vincristine, topotecan, and periocular carboplatin, with intensive focal treatments.
Event-free survival of eye will be defined per eye as the time interval from date on study to date of first event (an event includes external beam radiation or enucleation) or to last follow-up date for eyes without events. Event-free survival of eye will be estimated using the method of Kaplan and Meier. Standard error is 5-year EFS."|From date on-study to an event or last follow-up|Of the 52 eyes (26 evaluable patients), 2 eyes (2 patients) were removed from analysis as they were not responsive to window therapy. In both cases, the contralateral eye was included in the analysis. One patient with upfront enucleation had only one eye for analysis. Eleven eyes were R-E Group I-III and were excluded. Total: 38 eyes for analysis.||probability|Eyes|95% Confidence Interval|Number
712455|NCT00186888|Secondary|Ocular Survival of Stratum B Patients Responding to Window Treatment|"To estimate the 5-year ocular survival of bilateral disease patients with advanced intraocular retinoblastoma in either eye (R-E IV-V) responding to the vincristine/topotecan window, with alternating cycles of vincristine and carboplatin with vincristine, topotecan, and periocular carboplatin, with intensive focal treatments.
Ocular survival will be defined per patient as follows: for patients with one advanced stage eye, the time interval from date on study to date of enucleation of advanced stage eye or date of last follow-up, for patients with two advanced stage eyes, the time to the first enucleation will be used for analysis. Ocular survival will be estimated using the method of Kaplan and Meier. Standard error is 5-year ocular survival"|From date on-study to an event or last follow-up|From the total of 27 eligible patients in stratum B, 3 patients were not responding to the window therapy; 1 withdrew the consent and was taken off the study, and 2 developed disease progression. Thus, the Kaplan and Meier estimate of ocular survival was calculated for the remaining 24 patients.||probability||95% Confidence Interval|Number
712456|NCT00186888|Secondary|Event-free Survival of Stratum B Patients Responding to Window Treatment|"To estimate the 5-year event-free (EFS) survival of bilateral disease patients with advanced intraocular retinoblastoma in either eye (R-E IV-V) responding to the vincristine/topotecan window, with alternating cycles of vincristine and carboplatin with vincristine, topotecan, and periocular carboplatin, with intensive focal treatments.
Event-free survival will be defined per patient as follows: for patients with one advanced stage eye, the time interval from date on study to date of first event (an event includes external beam radiation or enucleation) of advanced stage eyes, time to first event will be used for the analysis. Event-free survival will be estimated using the method of Kaplan and Meier."|From date on-study to an event or last follow-up|Of the total 27 eligible patients in stratum B, 3 patients were not responding to the window therapy; 1 withdrew the consent and was taken off the study, and 2 developed disease progression. Kaplan and Meier estimate of ocular survival was calculated for the remaining 24 patients.||probability||95% Confidence Interval|Number
712457|NCT00186888|Secondary|Relationship Between Topotecan Clearance (CL) and ABCG2/B1 Genotype in Stratum B Participants.|Blood samples for pharmacokinetic studies were collected at 0 hour (pre-dose), 5 minutes, 1.5 and 2.5 hours after the end of topotecan dose on Course 1 Day 1, Course 2 Day 1, and if further studies were needed, Course 5 Day 1 and Course 8 Day 1. A blood sample for pharmacogenetic studies was collected during the course of therapy on protocol.|Courses 1, 2, 5, and 8|"Of the 107 participants enrolled in the overall study, analysis was performed for 19 participants who were enrolled on Stratum B AND who had results for both topotecan clearance and pharmacogenetic studies.
Only wild-type was present in BCRP 15994, therefore, statistical analysis was not done for these alleles."||Liters/hour/m^2||95% Confidence Interval|Median
712458|NCT00186888|Secondary|Relationship Between Topotecan Clearance (CL) and CYP3A4/5 Genotype in Stratum B Participants.|Blood samples for pharmacokinetic studies were collected at 0 hour (pre-dose), 5 minutes, 1.5 and 2.5 hours after the end of topotecan dose on Course 1 Day 1, Course 2 Day 1, and if further studies were needed, Course 5 Day 1 and Course 8 Day 1. A blood sample for pharmacogenetic studies was collected during the course of therapy on protocol.|Courses 1, 2, 5, and 8|"Of the 107 participants enrolled in the overall study, analysis was performed for 19 participants who were enrolled on Stratum B AND who had results for both topotecan clearance and pharmacogenetic studies.
Only wild-type was present in CYP3A5*6, therefore, statistical analysis was not done for these alleles."||Liters/hour/m^2||95% Confidence Interval|Median
712459|NCT00186888|Secondary|Stratum B Response Rate of Early Stage Eyes to Window Therapy|To estimate the proportion of early stage eyes defined as Reese-Ellsworth Group I, II, or III eyes, that responded to 2 courses of window therapy which consisted of vincristine and topotecan|Six weeks post window therapy.|Among the 27 stratum B patients with 54 eyes with retinoblastoma, 12 eyes were early stage (Reese-Ellsworth group I, II, or III). The remaining 42 eyes were advanced stage and were not included in this analysis.||Participants|||Number
712461|NCT00186901|Secondary|Mean QCT Z-Score by Bsm 1 Vitamin D Receptor Genotype|The Bsm1 Vitamin D Receptor has been associated with bone mineral density and bone turnover markers in various patient cohorts but has not been investigated I survivors of childhood|At enrollment|Of the 424 patients screened, 417 participants consented for genetic testing. Of the 417 patients screened for the Bsm 1 vitamin D receptor, only 41 had the BB genotype, 65 had the Bb genotype, and 77 had the bb genotype.||QCT Z-Score||Standard Deviation|Mean
712746|NCT00197496|Secondary|Falls Self Efficacy||discharge|||units on a scale||Standard Deviation|Mean
712747|NCT00197496|Secondary|Timed up and Go||discharge|||seconds||Standard Deviation|Mean
712463|NCT00186901|Secondary|Quantitative Computed Tomography (QCT) and Dual Energy X-ray Absorptiometry (DXA) Scan Scores for Bone Mineral Density.|To compare the bone mineral density scores determined by Quantitative Computed Tomography (QCT) with those determined by dual energy x-ray absorptiometry (DXA) scan. 180 patients were assessed at 36 months by the QCT method and 89 were evaluated using the DXA methods to assess Bone Mineral Density. 89 patients received both scans.|36 months|180 patients were assessed at the 36 months interval and received a QCT Scan. 89 patients were also assessed using the DEXA Scan. Comparison of the two methods produced 89 paired studies to arrive at a correlation.||Z-score||Standard Deviation|Median
712464|NCT00186901|Secondary|Quantitative Computed Tomography (QCT) and Dual Energy X-ray Absorptiometry (DXA) Scan Scores for Bone Mineral Density.|To compare the bone mineral density scores determined by Quantitative Computed Tomography (QCT) with those determined by dual energy x-ray absorptiometry (DXA) scan. 188 patients were assessed at 24 months by the QCT method and 90 were evaluated using the DXA methods to assess Bone Mineral Density. 90 patients received both scans.|24 months|188 patients were assessed at the 24 months interval and received a QCT Scan. 90 patients were also assessed using the DXA Scan. Comparison of the two methods used 90 paired studies to arrive at a correlation.||Z-score||Standard Deviation|Mean
712465|NCT00186901|Secondary|Quantitative Computed Tomography (QCT) and Dual Energy X-ray Absorptiometry (DXA) Scan Scores for Bone Mineral Density.|To compare the bone mineral density scores determined by Quantitative Computed Tomography (QCT) with those determined by dual energy x-ray absorptiometry (DXA) scan. 218 patients were assessed at 12 months for QCT. 94 were evaluated using DXA. 94 patients received both scans.|12 months|218 patients were assessed at the 12 months interval and received a QCT Scan. 94 patients were also assessed using the DXA Scan. Comparison of the two methods used 94 paired studies to arrive at a correlation.||Z-score||Standard Deviation|Mean
712466|NCT00186901|Secondary|Quantitative Computed Tomography (QCT) and Dual Energy X-ray Absorptiometry (DXA) Scan Scores for Bone Mineral Density.|To compare the bone mineral density scores determined by Quantitative Computed Tomography (QCT) with those determined by dual energy x-ray absorptiometry (DXA) scan. 121 patients at baseline were assessed by both method the QCT and DXA methods to assess Bone Mineral Density.|Baseline|275 patients were assessed at baseline and received a QCT Scan. 121 patients were also assessed using the DEXA Scan. Comparison of the two methods used 121 paired studies to arrive at a correlation coefficient.||Z-score||Standard Deviation|Mean
712467|NCT00186901|Primary|Bone Mineral Density by Age Group of ALL Survivors|Using bone mineral density Z-score, assess relationship between predisposing factors (age groups) and bone mineral density; a negative value indicates a deficit in bone mineral density.|Baseline|Assess baseline participants to determine whether age was a contributing factor in bone mineral density.||Z-score||Standard Error|Median
712468|NCT00186901|Primary|Bone Mineral Density by Race of ALL Survivors|Using bone mineral density Z-score, assess relationship between predisposing factors (race) and bone mineral density; a negative value indicates a deficit in bone mineral density.|Baseline|Assess baseline participants to determine whether race contributed to bone mineral density.||Z-score||Standard Error|Median
712469|NCT00186901|Primary|Bone Mineral Density in Male and Female ALL Survivors|Using bone mineral density Z-score, assess relationship between predisposing factors (gender) and bone mineral density; a negative value indicates a deficit in bone mineral density.|Baseline|Baseline participants were assessed to determine whether gender was a pre-disposing factor for bone mineral density.||Z-score||Standard Error|Median
712470|NCT00186901|Primary|Effect of Taking Calcium and Vitamin D Supplements on Bone Mineral Density (BMD)|The effect of taking calcium and vitamin D supplements was measured using Quantitative Computed Tomography (QCT) to calculate a QTC Z score. A standardized Z-score was calculated to indicate the difference between the patient’s Bone Mineral Density (BMD) and the mean value for age and gender-appropriate controls. Z-scores from 0 to +2 are considered normal, above +2 are considered to be elevated, from 0 to -1 are considered to represent a mild BMD deficit, between -1 and -2 are considered to represent moderate deficits, and below -2 are considered to represent severe deficits.|Baseline, 12 months, 24 months, and at 36 months or study end|Of the 275 pts identified with BMD z-scores < 0, 134 were randomized to the placebo group and 141 to the supplement group. Bone Mineral Density QCT Z-scores were calculated at baseline, 12 months, 24 months, and at 36 months or study end.||Z-Score||Full Range|Median
712471|NCT00187096|Secondary|Overall Survival|"Overall survival is defined as the time relapse from on study date to death with those alive at last follow up date censored. The Kaplan-Meier method was used to compute survival probability estimates and confidence interval was determined by binomial distribution (for no events or all events) or by log hazard method. The binomial interval is based on the number of patients at risk.
The confidence intervals for Arm 1 and Arm 2a were determined by binomial distribution.
The confidence interval for Arm 2b was determined by log hazard method."|Up to 2 years post NK cell transplantation|||Percent probability||95% Confidence Interval|Number
712472|NCT00187096|Secondary|Relapse-free Survival|For Arm 1, the efficacy of NK cell transplantation will be reported as the proportion of participants who achieve complete or partial remission. Kaplan-Meier estimates of relapse-free survival and confidence interval was determined by binomial distribution because no events were observed. The binomial interval is based on the number of patients at risk.|Up to 2 years post NK cell transplantation|||Percent probability||95% Confidence Interval|Number
712473|NCT00187096|Secondary|Number of Participants With Evidence of NK Cells Lysing a Target Cell Line (K562)|NK cells in recipient achieving ability to lyse target cell line (K562) within normal range established by donor NK cells.|Days 2, 7, 14, 21, and 28 after NK cell transplantation|All 10 participants received NK donor cells; 9 of the 10 participants received KIR-mismatched NK donor cells.||participants|||Number
712474|NCT00187096|Secondary|Number of KIR-mismatched NK Cells|Number of KIR-mismatched donor NK cells in recipients’ blood at day 2 and day 14 post NK cell infusion.|Day 2 and day 14 post NK cell transplantation|Nine of the 10 participants in Arm 1 received KIR-mismatched NK donor cells.||cells/µl||Full Range|Median
712475|NCT00187096|Secondary|Day That Maximum NK Cell Engraftment Was Reached|The time elapsed after transplantation in days until peak KIR-mismatched donor NK cell expansion was reached in recipients|Day 0 through Day 28 post NK cell transplantation|Nine of the 10 participants in Arm 1 received KIR-mismatched NK donor cells.||number of days||Full Range|Median
712530|NCT00203216|Secondary|Change in Average Severity if Migraine Attacks Per Each Consecutive 4-week Interval of the Treatment Period as Compared to the 4-week Baseline Period||Baseline period compared to 28 day interval prior to Visit 4-7.||||||
712476|NCT00187096|Secondary|Percent of Detectable Donor NK Cells at Day 28|The percent of detectable donor NK cells in recipients at 28 days after NK cell infusion. Three of 10 participants had detectable donor cells at week 4. The results report the percent of detectable cells in the 3 participants.|At 28 days|Three of 10 participants continued to have detectable donor NK cells at week 4.||percent of donor NK cells||Full Range|Median
712477|NCT00187096|Secondary|Percent of Peak NK Cell Chimerism|The maximum percent of donor NK cell in recipients during a four-week period after NK cell infusion.|Days 2, 7, 14, 21 and 28 after NK cell transplantation|Arm 2 participants were not analyzed for this outcome as many of these patients proceeded to allogeneic stem cell transplantation following NK cell transplantation.||percent of NK cells||Full Range|Median
712478|NCT00187096|Secondary|Duration of Engraftment of Natural Killer (NK) Cells|NK cell engraftment defined as NK cell chimerism in recipients.|Measured at days 2, 7, 14, 21 and 28 after NK cell transplantation, and up to 189 days post transplant as clinically indicated|Arm 2 participants were not analyzed for this outcome as many of these patients proceeded to allogeneic stem cell transplantation following NK cell transplantation.||Days||Full Range|Median
712479|NCT00187096|Primary|Proportion of Patients Experiencing Grade 3 or 4 Toxicities During Conditioning and up to 100 Days Post-transplant|Document the proportion of patients experiencing grade 3 or 4 toxicities during conditioning and up to 100 days post-transplant. Toxicities were identified using Common Toxicity Criteria V 3.0 criteria.|Beginning at on therapy through 100 days post-transplant|Grade 3 and 4 toxicities were assessed using Common Toxicity Criteria V.3.0 The assessment period was from the date on therapy through 100 days post-transplant.||proportion of patients|||Number
712480|NCT00187096|Primary|Number of Patients Experiencing Grade 3 or 4 Toxicities During Conditioning and up to 100 Days Post-transplant|Document the number of patients experiencing grade 3 or 4 toxicities during conditioning and up to 100 days post-transplant. Toxicities were identified using Common Toxicity Criteria V 3.0 criteria.|Beginning at on therapy through 100 days post-transplant|Grade 3 and 4 toxicities were assessed using Common Toxicity Criteria V.3.0 The assessment period was from the date on therapy through 100 days post-transplant.||participants|||Number
712481|NCT00187135|Secondary|Movement|Movement (yes/no) measured during recovery after surgery.|The participant was monitored from the end of the procedure until sedation recovery, which lasted a maximum of 65 min. Discharge from the recovery area was determined by hospital standards of care.|Due to study termination, not all participants completed three planned visits. 107 of the 162 participants enrolled on study received treatment with Fentanyl 0.5 mcg/kg. 104 of the 162 participants enrolled on study received treatment with Fentanyl 1mcg/kg. 105 of the 162 participants enrolled on study received treatment with Placebo.||Participants|||Number
712482|NCT00187135|Secondary|20% or Greater Change in Blood Pressure|Measurements of 20% change in blood pressure(yes/no) taken during recovery after surgery.|The participant was monitored from the end of the procedure until sedation recovery, which lasted a maximum of 65 min. Discharge from the recovery area was determined by hospital standards of care.|Due to study termination, not all participants completed three planned visits. 107 of the 162 participants enrolled on study received treatment with Fentanyl 0.5 mcg/kg. 104 of the 162 participants enrolled on study received treatment with Fentanyl 1mcg/kg. 105 of the 162 participants enrolled on study received treatment with Placebo.||Participants|||Number
712483|NCT00187135|Secondary|20% or Greater Change in Respiratory Rate|Measurements of 20% change in respiratory rate(yes/no) taken during recovery after surgery.|The participant was monitored from the end of the procedure until sedation recovery, which lasted a maximum of 65 min. Discharge from the recovery area was determined by hospital standards of care.|Due to study termination, not all Participants completed three planned visits. 107 of the 162 participants enrolled on study received treatment with Fentanyl 0.5 mcg/kg. 104 of the 162 participants enrolled on study received treatment with Fentanyl 1mcg/kg. 105 of the 162 participants enrolled on study received treatment with Placebo.||Participants|||Number
712484|NCT00187135|Secondary|20% or Greater Change in Heart Rate|Measurements of 20% change in Heart Rate (yes/no) taken during recovery after surgery.|The participant was monitored from the end of the procedure until sedation recovery, which lasted a maximum of 65 min. Discharge from the recovery area was determined by hospital standards of care.|Due to study termination, not all Participants completed three planned visits. 107 of the 162 participants enrolled on study received treatment with Fentanyl 0.5 mcg/kg. 104 of the 162 participants enrolled on study received treatment with Fentanyl 1mcg/kg. 105 of the 162 participants enrolled on study received treatment with Placebo.||Participants|||Number
712485|NCT00187135|Primary|Pain (Yes/No)|During the sedation recovery period, pain was measured by one of three validated pediatric scales. Scales were applied according to the developmental ability of the participant: Numerical Pain Scale, FACES pain scale, and FLACC pain scale (a score based on behaviors observed: face, legs, activity, cry, and consolability). All three scales are scored from 0 – 10 units on a scale, and are interchangeable for comparison purposes. Any score >0 was coded “pain”, and score of 0 was coded “no pain”, yielding one score for each participant’s procedure.|The participant was monitored from the end of the procedure until sedation recovery, which lasted a maximum of 65 min. Discharge from the recovery area was determined by hospital standards of care.|Participants in this analysis are a subset of the 162 participants randomized since not all completed 3 visits on study. If a participant completed at least Visit 2 and received each of the 2 treatments compared they are included. Treatment on each visit was randomized; therefore these numbers cannot be derived directly from the participant flow.||Participants|||Number
712486|NCT00187135|Primary|Pain(Yes/No)|During the sedation recovery period, pain was measured by one of three validated pediatric scales. Scales were applied according to the developmental ability of the participant: Numerical Pain Scale, FACES pain scale, and FLACC pain scale (a score based on behaviors observed: face, legs, activity, cry, and consolability). All three scales are scored from 0 – 10 units on a scale, and are interchangeable for comparison purposes. Any score >0 was coded “pain”, and score of 0 was coded “no pain”, yielding one score for each participant’s procedure.|The participant was monitored from the end of the procedure until sedation recovery, which lasted a maximum of 65 min. Discharge from the recovery area was determined by hospital standards of care.|Participants in this analysis are a subset of the 162 participants randomized since not all completed 3 visits on study. If a participant completed at least Visit 2 and received each of the 2 treatments compared they are included. Treatment on each visit was randomized; therefore these numbers cannot be derived directly from the participant flow.||Participants|||Number
712487|NCT00192647|Secondary|Change From Baseline in Log10 HCV RNA Values|The mean decrease in log10 HCV RNA levels from baseline was assessed in both the induction group and the standard group.|Baseline, Weeks 4, 8, 12, 24, and at end of treatment (EoT) (maximum up to Week 48)|ITT analysis population; Here, number of participants analyzed = number of participants evaluable for this outcome measure; 'n' = number of participants analyzed at specified time point for reported group, respectively.||Log 10 IU/mL||Standard Deviation|Mean
712488|NCT00192647|Secondary|Percentage of Participants With Predictive Values of Virological Response for Sustained Virological Response|The ability of virological responses to predict sustained virological response according to the scheduled treatment periods was assessed in terms of positive predictive value (PPV) and negative predictive value (NPV). The PPV indicates probability of achievement of viral suppression (undetectable HCV RNA) for achieving a sustained virological response and the NPV indicates probability of not achieving viral suppression for not achieving a sustained virological response. The PPV at Week 4 or 12 was calculated as the number of participants who achieved viral suppression both at Week 4 or 12 and at Week 72 divided by the number of participants who achieved viral suppression at Week 4 or 12, multiplied by 100. The NPV at Week 4 or 12 was calculated as the number of participants who failed to achieve viral suppression at Week 4 or 12 and at Week 72 divided by the number of participants who failed to achieve viral suppression at Week 4 or 12, multiplied by 100.|Weeks 4, 12, and 72|ITT analysis population; participants who did not have an HCV RNA measurement at Week 4 or 12 and at Week 72 were excluded from the analysis. Here, number of participants analyzed = number of participants evaluable for this outcome measure; 'n' = number of participants analyzed at specified time point for reported group, respectively.||percentage of participants|||Number
712489|NCT00192647|Secondary|Percentage of Participants With Relapse of End-of-treatment Virological Response|Relapse was determined based on virological response at the actual end of treatment and was calculated by dividing the number of participants who achieved a virological response at end of treatment but later had detectable HCV RNA at the last assessment post-treatment by the number of participants with a virological response at end of treatment, defined as undetectable HCV RNA (<15 IU/mL). Participants who achieved a virological response at end of treatment but did not have any HCV RNA assessment during follow-up were excluded and were not considered as having relapsed. However, if no assessment was available within the end of-treatment time window but the participant had a sustained virological response according to the actual treatment period, backward imputation was used and the participant was considered to have achieved an end-of-treatment virological response in the analysis.|Actual end of treatment (Week 48) up to last follow up (maximum up to Week 72)|ITT analysis population. Here, number of participants analyzed signifies participants who had end of treatment virologic response and had HCV RNA measurement available during follow-up.||percentage of participants|||Number
712490|NCT00192647|Secondary|Percentage of Participants With Virological Responses Over Time|Virological response was defined as undetectable HCV RNA (<15 IU/mL) as measured by the Roche TaqMan HCV Test. Participants without HCV RNA measurements at a study week are considered non responders at that study week.|Weeks 4, 8, 12, and 24|ITT analysis population||percentage of participants|||Number
712491|NCT00192647|Secondary|Percentage of Participants With End-of-Treatment Virological Response According to Scheduled Treatment Period|Virological response at the end of the scheduled treatment period was defined as the percentage of participants with undetectable (<15 IU/mL) HCV RNA as measured by the Roche TaqMan HCV Test at Week 48.|Weeks 48|ITT analysis population||percentage of participants|||Number
712492|NCT00192647|Primary|Percentage of Participants With Sustained Virological Response According to Scheduled Treatment Period|Sustained virological response was calculated as the percentage of participants with undetectable (less than [<] 15 international units per milliliter [IU/mL]) hepatitis C virus (HCV) ribonucleic acid (RNA) as measured by the Roche TaqMan HCV Test 24 weeks after completion of the scheduled 48-week treatment period.|Week 72|ITT analysis population||percentage of participants|||Number
712493|NCT00201448|Primary|Immunology Response|The primary objective of the study is to evaluate safety and immune responses induced by the Towne vaccine in in seronegative women with children in daycare|Urine, saliva, will be collected every 2 months for 12 months and serum will be collected 1,2,4,6, 9, 12, 18, 24, 30 and 36 months after vaccination.|Study was terminated (suspended due to lack of funding). PI is no longer with the institution; data and results cannot be accessed, analyzed, and reported.|||||
712494|NCT00201448|Primary|Participants With Adverse Events||One year|per protocol and randomized||participants|||Number
712495|NCT00201643|Secondary|Maternal Infectious Morbidity.|Total number of Mothers having Maternal infectious morbidity (e.g. endometritis & maternal sepsis) noted from birth through 28 days after birth|Up to 28 days after giving birth|ITT||participants|||Number
712496|NCT00201643|Secondary|Number of Neonates With Pneumothorax|Total number of neonates with pneumothorax diagnosed postpartum.|birth to 28 days of life|ITT||participants|||Number
712497|NCT00201643|Secondary|Number of Neonates Who Required Surfactant Therapy After Birth.|The Number of neonates who required surfactant therapy within the first 28 days after birth.|Birth to 28 days of life|ITT||participant|||Number
712498|NCT00201643|Secondary|Number of Babies Who Required Ventilatory Support Within the First 28 Days of Life.|The number of babies who required ventilatory support within the first 28 days of life. Equal to or great than 12 hours was considered one day.|birth to 28 days of life|Intent to treat (ITT)||participants|||Number
712499|NCT00201643|Secondary|Neonatal Head Circumference Taken at Time of Birth.|Reported as the average of all neonatal head circumferences (HC) taken at time of birth in each group.|Birth|Intent to treat||centemeters (cm)||Standard Deviation|Mean
712500|NCT00201643|Secondary|Interuterine Growth Restriction (IUGR) or Small for Gestational Age(SGA)in Babies Delivering at < 34 Weeks Gestation.|Noted as the total number of Neonates delivering at < 34 weeks gestation for which their weights fell within the 10th percentile at time of birth.|Measured at birth.|Intent to Treat||paticipants|||Number
712501|NCT00201643|Secondary|Neonatal Birth Weight Reported in Grams|Measured mean Birth weights of Neonates in each arm as reported in grams on the birth record.|At time of Birth|Intent to treat protocol||grams||Standard Deviation|Mean
712502|NCT00201643|Secondary|Gestational Age at (@) Delivery|Reported the average/mean Neonatal gestational age (GA) (reported in weeks of pregnancy) at the time of birth for both groups (ACS vs. Placebo).|gestational age at delivery in weeks of gestation|Modified intent to treat||Weeks||Standard Deviation|Mean
712503|NCT00201643|Primary|Composite Neonatal Morbidity < 34 Weeks Gestation at Time of Birth.|This outcome measured the total number of neonates with Composite Neonatal morbidity who delivered at < 34 weeks gestation. Composite Morbidity consisted of respiratory distress syndrome, bronchopulmonary dysplasia, severe intraventricular hemorrhage, periventricular leukomalacia, proven sepsis, necrotizing enterocolitis, or perinatal death|From birth to 28 days of life|This was an intent to treat protocol. In patients delivering before 34 weeks we estimated that the sample size of at least 217 subjects in each arm would be needed to have 80% power to detect a 40% reduction in neonatal morbidity (to 16.8%).||participants|||Number
712504|NCT00201734|Secondary|Time to Tumor Progression for Patients|For patients enrolled on the Phase II portion of the trial the time to progression was measured as the time from when the patient started treatment to the time the patient is first recorded as having disease progression or the date of death if the patient dies due to causes other than disease progression.|Up to 6 years|||months||95% Confidence Interval|Median
712505|NCT00201734|Secondary|One Year Survival for Patients|For patients enrolled on the Phase II portion of the trial the One-year survival was measured as the percentage of patients alive 1 year after their treatment in the trial.|Up to 1 year|||percent of patients||95% Confidence Interval|Number
712506|NCT00201734|Secondary|Progression-Free Survival at 6 Months for Patients|For patients enrolled on the Phase II portion of the trial Progression Free Survival (PFS) was measured from the percentage of patients that were still alive, without evidence of disease progression for 6 months following the initiation of treatment. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|up to 6 years|||percent of patients||95% Confidence Interval|Number
712507|NCT00201734|Secondary|Phase I: To Determine Side Effects|The common clinically significant grade 3 and 4 toxicities graded using the National Cancer Institutes Common Toxicity Criteria version 3.0|Every 3 weeks, for up to 24 weeks|Three patients enrolled on Phase I portion of trial were not evaluable for toxicity.||percent of patients|||Number
712508|NCT00201734|Primary|Objective Response Rate (ORR) for the Phase II Portion of the Study. CR+PR Per RECIST v1.0 Criteria Using a Single Arm , Two Stage Minimax Design.|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Every 3 weeks, for up to 24 weeks|The Phase II study was prematurely terminated at 25 patients due to cessation of funding||percent of patients||95% Confidence Interval|Number
712509|NCT00201734|Primary|Maximum Tolerated Dose in Phase I Portion of Study|Determine the maximum tolerated dose of the triplet combination of capecitabine that can be administered in combination with weekly paclitaxel and every four weeks carboplatin.|Every 3 weeks, for up to 24 weeks|||mg/m2|||Number
712510|NCT00201773|Secondary|Evaluate Response Rate of Neoadjuvant Exemestane and Celecoxib in Postmenopausal Women.|Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response, Disappearance of all target lesions; Partial Response, >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease, <30% decrease in the sum of the longest diameter of target lesions; Progressive Disease, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|up to 16 weeks|Clinical Response was determined by physical exam and breast Ultrasound at baseline and repeated at 8 weeks and 16 weeks, and pathological response by histopathological examination of primary tumor and axillary nodes after definitive breast cancer surgery.||patients|||Number
712511|NCT00201773|Primary|Number of Patients With Decreased Gene Expression of CYP19 in Breast Cancer by Adding COX-2 Inhibitor to Exemestane|Collected from postmenopausal women that receive neoadjuvant exemestane.|up to 16 weeks|Comparison of immunohistochemistry (IHC) Allred Differences with Neoadjuvant Therapy||patients|||Number
712512|NCT00203047|Secondary|Change From Baseline to Month 36 or Early Termination Visit in Volume of Hypointense Lesions|"Results represent the database as of January 29, 2009.
The difference in hypointense brain lesion volume as observed in MRIs from baseline to Month 36 or the early termination visit. Hypointense lesions display as dark areas on the MRI image, and represent areas of permanent axonal damage."|Day 0, Month 36 or early termination visit|Treated population of participants with an MRI at the stated time frames.||cm^3||Standard Deviation|Mean
712513|NCT00203047|Secondary|Change From Baseline to Month 36 or Early Termination Visit in Volume of T2-Lesions|"Results represent the database as of January 29, 2009.
The difference in T2 brain lesion volume as observed in MRIs from baseline to Month 36 or the early termination visit. T2 lesions are hyperintense lesions meaning that they appear as bright spots on the MRI image. These tend to show the total number of lesions and disease burden."|Day 0, Month 36 or the early termination visit|Treated population of participants with an MRI at the stated time frames.||cm^3||Standard Deviation|Mean
712514|NCT00203047|Secondary|Cumulative Number of Enhancing Lesions at Months 12, 24 and 36|"Results represent the database as of January 29, 2009.
Enhancing lesions are lesions that show inflammation on an MRI and are assumed to be new lesions. The sum of enhancing lesions observed in MRIs taken at months 12, 24 and 36 are offered."|Months 12, 24, and 36|Treated population who had at least a 12 month MRI||lesions||Standard Deviation|Mean
712515|NCT00203047|Primary|Percent Change From Baseline to Termination in Normalized Brain Volume Measured According to the SIENA (Structural Imaging Evaluation Using Normalization of Atrophy) Method|"Results represent the database as of January 29, 2009. Brain volume was measured at baseline and at months 24, 36 and at early termination visits by magnetic resonance imaging (MRI). Brain atrophy was measured by comparing the change in brain volume from baseline to the latest scan at the three during study timeframes. SIENA is a fully automated method of analyzing longitudinal brain change.
Adjusted (least square) mean values are presented."|Day 0, latest scan at month 24, 36 or early termination visit|Treated population of participants who had both a baseline MRI and an MRI at least one of the three during study time frames. The latest MRI was used if more than one during study MRI was available.||percent change of baseline brain volume||Standard Error|Least Squares Mean
712516|NCT00203203|Secondary|Linear Local Shortening (LLS)|Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Linear Local Shortening (LLS)which is an indicator of mechanical properties of the heart and measured as a percentage (%)of local contraction.|baseline and 6 months|||percentage of linear local shortening||Standard Deviation|Mean
712517|NCT00203203|Secondary|Endocardial Unipolar Voltages (UPV)|Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Endocardial Unipolar Voltages (UPV)in millivolts(mV)which may be indicative of scar tissue. Normal is <5.5 mV.|baseline and 6 months|The data was analyzed for all participants in control and treated groups.||Unipolar voltage (mV)||Standard Deviation|Mean
712518|NCT00203203|Secondary|Left Ventricular End-Systolic Volume (LVESV) (ml)|Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Left Ventricular End-Systolic Volume (LVESV)when the blood moves from the ventricles to the atria during the contraction cycle. Measured as volume in milliliters (ml). Normal is approximately 60- 65 milliliters.|baseline, 3 months and 6 months|The data was analyzed for all participants in control and treated groups.||ml||Standard Deviation|Mean
712519|NCT00203203|Secondary|Left Ventricular End-Diastolic Volume (LVEDV)|Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Left Ventricular End-Diastolic Volume (LVEDV)which is the volume of blood inside the left ventricle when the heart has completed its filling cycle. The volume of the left ventricle is measured during contraction and relaxation. Normal heart volume inside the left ventricle is about 140 milliliters.|baseline, 3 months and 6 months|||Volume in left ventricle (milliliters)||Standard Deviation|Mean
712520|NCT00203203|Secondary|Angiography Left Ventricular Ejection Fraction (LVEF) Percent (%)|"Clinical and functional assessment in endstage ischemic cardiomyopathy patients using angiography left ventricular ejection fraction (LVEF) percent (%) which is an invasive method used to estimate how well the heart is pumping blood through the ventricle and is considered the gold standard."|baseline and 6 months|The data was analyzed for all participants in control and treated groups.||Angiography LVEF (%)||Standard Deviation|Mean
712521|NCT00203203|Secondary|Single-photon Emission Computed Tomography (SPECT) Imaging for Left Ventricular Ejection Fraction (LVEF) Percentage (%)|Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Single-photon emission computed tomography (SPECT) imaging for Left Ventricular Ejection Fraction (LVEF) percentage (%)to determine how well the heart is pumping blood from the left ventricle. Different method for evaluating how much (%) of blood is pumped through heart with each contraction.|baseline, 3 months and 6 months|The data was analyzed for all participants in control and treated groups.||Left Ventricular Ejection Fraction (%)||Standard Deviation|Mean
712522|NCT00203203|Secondary|Echocardiography Wall Motion Score Index (WMSI)|Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Echocardiography Wall Motion Score Index (WMSI)which allows detection of abnormalities in the heart wall or blood flowing through the heart. Normal contracting Left Ventricle has WMSI of 1. Larger WMSI indicates higher degree of abnormalities (2 for hypokinetic, 3 for akinetic, 4 for dyskinetic, and 5 for aneurysmal). WMSI was calculated as the sum of scores divided by the total number of segments.|baseline and 3 months|The data was analyzed for all participants in control and treated groups.||Wall Motion Score Index||Standard Deviation|Mean
712523|NCT00203203|Secondary|Minute Ventilation- Carbon Dioxide Production Relationship (VE/VCO2 Slope)|Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Minute Ventilation- Carbon Dioxide Production Relationship (VE/VCO2 slope)measure during a cardiopulmonary exercise test has a high prognostic value for survival in heart failure patients. Normal VE (milliliters per minute)/VCO2 (milliliters per minute)equals 25.|baseline and 3 months|The data was analyzed for all participants in control and treated groups.||VE/VCO2 slope||Standard Deviation|Mean
712524|NCT00203203|Secondary|Echocardiography (EF)Percent (%)|Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Echocardiography measures ejection fraction(EF)as a percentage(%) of blood leaving the heart with each beat or contraction. It can provide information concerning structural characteristics and blood flow in the heart and blood vessels. A normal heart pumps 50-75% of the blood with each contraction.|baseline, 3 months and 6 months|The data was analyzed for all participants in control and treated groups.||Ejection Fraction %||Standard Deviation|Mean
712525|NCT00203203|Secondary|Myocardial Oxygen Consumption (MVO2)|Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Myocardial Oxygen Consumption (MVO2)which is the amount of oxygen used by the heart muscle and is indicative of heart muscle function. Normal value is 15.5 Volume %. Measured as milliliters (ml) oxygen per kilogram (kg) body weight per minute.|baseline, 3 months and 6 months|The data was analyzed for all participants in control and treated groups.||Percentage of Oxygen Saturation||Standard Deviation|Mean
712526|NCT00203203|Secondary|New York Heart Association (NYHA)Classification|"Clinical and functional assessment in endstage ischemic cardiomyopathy patients using New York Heart Association (NYHA)Classification and indicates extent of heart failure based on limitations in physical activity.
Class I- No symptoms/limitation in ordinary physical activity (shortness of breath when walking, etc) Class II-Mild symptoms/slight limitation during ordinary activity Class III- Marked limitation in activity due to symptoms, even during less-than-ordinary activity Class IV- Severe limitations in activity/experiences symptoms while at rest (bedbound)"|baseline, 3 months and 6 months|The data was analyzed for all participants in control and treated groups.||NYHA Functional Class||Standard Deviation|Mean
712527|NCT00203203|Secondary|Canadian Cardiovascular (CCS) Angina Score|"Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Canadian Cardiovascular (CCS) Angina Score which indicates discomfort from angina (chest pain).
Class I- Angina only during strenuous or prolonged activity Class II- Slight limitation, with angina only during vigorous physical activity Class III- Symptoms with everyday living activities (moderate limitation) Class IV- Inability to perform any activity without angina or angina at rest (severe limitation)"|baseline, 3 months and 6 months|The data was analyzed for all participants in control and treated groups.||units on a scale||Standard Deviation|Mean
712528|NCT00203203|Primary|Safety of Autologous-bone-marrow Injections|Safety of cell injections was assessed by reviewing adverse events at 3 time points: (1) up to 2 weeks post-procedure), (2) 3 months post-procedure, and (3) at 6 months post-procedure. Major adverse events were adjudicated (hospitalization, arrhythmia, exacerbation of congestive HF [CHF], acute coronary syndrome, myocardial infarction, stroke, or death).|up to 2 weeks post-procedure, 3 months and 6 months|Adverse events which occurred in all participants.||participants|||Number
712529|NCT00203216|Secondary|Change in Use of Acute Agents Attacks Per Each Consecutive 4-week Interval of the Treatment Period as Compared to the 4-week Baseline Period.||Baseline period compared to the 28 day period prior to each of the following visits: Visit 4-7.||||||
712531|NCT00203216|Secondary|Change in Number of Migraine Days Over Each 4-week Interval of the Treatment Period as Compared to the 4-week Baseline Period|"Number of migraine attacks will be measured at baseline (28 day period prior to start of study medication). The baseline number of attacks will be compared to that in the following 28 day intervals:
visit_4 = first follow-up interval (0 to 28 days after starting study drug)
visit_5 = second follow-up interval (28 to 56 days)
visit_6 = third follow-up interval (56 to 84 days)
visit_7 = fourth follow-up interval (84 to 126 days)"|Baseline period (day -28 to day 0) compared to the 28 day period prior to Visit 4-7.||||||
712532|NCT00203216|Primary|The Primary Outcome is Defined as Average Change in Frequency of Migraine Attacks Over Each 4-week Interval of the Treatment Period as Compared to the 4-week Baseline Period.|"Number of migraine attacks will be measured at baseline (28 day period prior to start of study medication). The baseline number of attacks will be compared to that in the following 28 day intervals:
visit_4 = first follow-up interval (0 to 28 days after starting study drug)
visit_5 = second follow-up interval (28 to 56 days)
visit_6 = third follow-up interval (56 to 84 days)
visit_7 = fourth follow-up interval (84 to 126 days) The change in headache attacks post-treatment will be averaged in a multiple regression model, looking at the following: visit number, age, gender, BMI"|Compare frequency of migraine attacks in baseline period to the average of the change following these 28 day periods prior to: Visit 4 (day 0-28), visit 5 (day 28-56), visit 6 (day 576-84), visit 7 (day 84-126).|||migraine attacks per month||Standard Deviation|Mean
712533|NCT00203229|Primary|Average Number of Pain Attacks|The average number of attacks daily experienced between Visit #1 and Visit #2 (baseline diary) was compared to the average daily number of attacks recorded between Visit #5 and Visit #7 after the patient has titrated the drug to the maximum tolerated dose.|Day 150 Visit #7|||Pain attacks||Standard Deviation|Mean
712534|NCT00203242|Secondary|Use of Acute and Rescue Medications During Loading (2 Days) and Maintenance Phases as Compared to Subject-reported Baseline. This Will be Calculated Using the Total Number of Doses of Acute Medications Per 24-hour Period Calendar Days.||Baseline compared to maintenance (up to 47 days)||||||
712535|NCT00203242|Secondary|Change in Frequency of Attacks Per 24 Hour Period, Duration of Individual Attacks (in Minutes), or Severity of Attacks Compared to the Subject-reported Baseline Values.||Compare Baseline through 47 days||||||
712536|NCT00203242|Primary|Time Required to Achieve a Greater Than or Equal to 50% Reduction in Frequency or Severity of Individual Cluster Attacks Compared to Subject-reported Baseline.|Severity: measured on an 11 point scale, where 0 = no pain and 10= excruciating pain. Outcome is time to 50% reduction in severity (or frequency) compared to baseline (prior to treatment).Frequency: Number of attacks per day.The Time to significant response was measured 2 ways: significant initial response and significant maintained response. For initial response, the time to significant response was: Mean of 2.1(1.5) days for severity and 1.9 (1.6) days for frequency. The time to significant response maintained was 29.7 (13.8) for severity and 29.0 (14.3) for frequency.|baseline (day 0) through 47 days after first infusion|||days||Standard Deviation|Mean
712537|NCT00203268|Primary|Number of Subjects Reporting Headache Relief at the 2 Hour Post Treatment Assessment. Relief Was Measured as a 2-point Change on a 4-point Scale (0=None, 1=Mild, 2=Moderate, 3=Severe)in Both the Early Treatment and Late Treatment Groups.|Data was collected at 2 hours post treatment to assess pain level. This assessment was done when subjects treated a migraine early (defined as treatment at 2 hours after onset of throbbing pain)and then late (defined as treatment at 4 hours after onset of throbbing pain). The proportion of subjects reporting headache relief at the 2 hour post treatment assessment was determined for each group and then compared.|2 hours post treatment and 4 hours post treatment|||participants|||Number
712538|NCT00203294|Secondary|To Evaluate Effect of Treatment on Associated Symptoms (Nausea, Phonophobia and Photophobia) as Measured Using a 4 Point Scale (None, Mild, Moderate, Severe) Compared to Historical Baseline, and Between the Two Treatment Groups.||20 minutes||||||
712539|NCT00203294|Secondary|To Evaluate the Effect of Treatment on Neck Pain in the Two Groups Compared to Historical Baseline, and Between the Two Treatment Groups.||20 minutes||||||
712540|NCT00203294|Primary|Decrease in Headache Pain, as Measured on an 11-point Pain Scale (0=no Pain, 10=Excruciating Pain). Change in Headache Pain 20 Minutes After Injection Will be Compared Between Treatment Groups.||20 minutes||||||
712541|NCT00203294|Primary|Headache Severity as Measured on an 11-point Verbal Scale (0 to 10):0=No Pain 10=Excruciating Pain|Headache severity was assessed on an 11-point verbal scale twenty minutes after treatment|20 minutes|There were 15 patients in group A (no steroids injected) and 14 in group B (steroids injected).||units on a scale||Standard Deviation|Mean
712542|NCT00203307|Secondary|Reduction in Days Using an Acute Headache Treatment During the Active Treatment Period as Compared to the Placebo Treatment Period, Per Subject.||84 day period on olanzapine compared to 84 day period on placebo||||||
712543|NCT00203307|Secondary|Reduction of Migraine Attack Frequency During Each 28-day Interval of the Active Treatment Period as Compared to Each 28-day Interval of the Placebo Treatment Period, Per Subject. Individual Migraine Attacks Are Separated by 48-hours Pain Free Time. A||each 28 day interval of active treatment c ompared to placebo||||||
712544|NCT00203307|Primary|Difference in Migraine Headache Periods During the Active Treatment Period as Compared to the Placebo Treatment Period, Per Subject.|"Definition of migraine headache period: One migraine period is defined as a 24-hour period starting at the time of onset of the migraine headache, during which the migraine headache is present*.
Definition of time frames: First treatment period: Day 1 to 84. Second treatment period: day 113-196. Washout phase is day 85-112."|84 day period on placebo compared to 84 day period on olanzapine|||headache periods||Standard Deviation|Mean
712545|NCT00203411|Secondary|Quality of Life of Patients|"Functional Assessment of Cancer Therapy-Colorectal (FACT-C) Trial Outcome Index (TOI) – a questionnaire assessing quality of life concerns pertinent to colorectal cancer patients. Questions address Physical, Emotional and Functional Well-Being. Scale: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), and very much (4). Higher numbers indicate a better state of well being. Scale 0 -136. Higher numbers indicating a better state of well-being.
The Overall scores for the FACT-C Composite scale range between 0-100 with higher scores indicating a better state of well being.
The EQ VAS= Euro Quality of Life 5 Dimension Self Reported Healthstate. It records the respondent’s self-rated health on a vertical, visual analogue scale where the endpoints are labeled 0 ‘Best imaginable health state’ and 100 ‘Worst imaginable health state’."|Baseline, Cycle 2, and End of Study|||score on a scale||Standard Deviation|Mean
712546|NCT00203411|Secondary|Response Rates|Evaluation of target lesions Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions|every 21 days up to 12 months|||participants|||Number
712547|NCT00203411|Primary|Number of Subjects Requiring Dose Modifications|Number of Subjects that required Bevacizumab or Capecitabine dose modifications, delay, reduction or discontinuation due to adverse reactions.|3 months|all subjects that received chemotherapy||participants|||Number
712548|NCT00203411|Primary|Time to Disease Progression|Progression Free Survival (PFS)- the interval from the date of enrollment to the first documented date of disease progression, death due to cancer, or the last date of a definitive assessment (not an unknown assessment) at which the patient is known to be progression-free. If there is an unknown assessment, then (a) if the next subsequent definitive assessment is complete response (CR), partial response (PR), or stable disease (SD), the patient is considered to be progression-free at the date of the subsequent definitive assessment and PFS is calculated as above; (b) if the next subsequent definitive assessment is progressive disease (PD), the patient is considered to be a failure at the time of the (earliest) assessment of unknown preceding the documented disease progression (i.e. PFS is back-dated to the date of the unknown assessment) and (c) if there is no subsequent definitive assessment, PFS for the patient is considered to be a censored observation at the date|12 months|||months||95% Confidence Interval|Median
712549|NCT00203424|Secondary|Overall Survival||Survival status was assessed every 3 months after completion of study treatment for a maximum of 3 years after administration of first study treatment|||participants|||Number
712550|NCT00203424|Primary|Time to Tumor Recurrence||Tumor progression assessed every 3 months during Follow-up Period for a maximum of 3 years after administration of first study treatment|||days||Full Range|Mean
712551|NCT00203424|Secondary|Time to Tumor Progression.|Measured once for participants who experienced tumor recurrence per protocol. Imaging done to measure tumor progression only after documented tumor recurrence|Tumor progression assessed every 3 months during Follow-up Period for a maximum of 3 years after administration of first study treatment|||days|||Number
712552|NCT00203424|Primary|To Evaluate the Efficacy of Bevacizumab Plus Erlotinib||Determined by time to tumor recurrence, as measured by rising prostate specific antigen (PSA) after radical prostatectomy.|Of the 23 subjects registered for treatment, 19 were analysed for efficacy, 4 subjects were excluded from analysis because of withdrawal of subjects prior to first tumor assessment.||participants|||Number
712553|NCT00203476|Secondary|Change in HDL From Baseline to 12 Weeks.||baseline and 12 weeks|Change in HDL||mg/dl||Standard Deviation|Mean
712554|NCT00203476|Secondary|Incidents of Rhabdomyolysis||12 weeks|||participants|||Number
712555|NCT00203476|Secondary|LFT Elevation||12 weeks|||participants|||Number
712556|NCT00203476|Primary|LDL Goal Attainment|Each participant had his LDL goal calculated based on the NCEP ATPIII guidelines.|12 weeks|intention to treat||participants|||Number
712557|NCT00203502|Secondary|Percentage of Participants With Pathologic Complete Response (pCR) Among Those With Triple Negative Breast Cancer|pCR rate for triple negative patients--percent|at surgery, one day|Patients with triple negative breast cancer||% pCR among triple negative pts||90% Confidence Interval|Number
712558|NCT00203502|Secondary|To Measure the Change in Left Ventricular Ejection Fraction (LVEF) From Baseline|Absolute change in LVEF, where LVEF values are measured in percentage units|Immediately before treatment and 1 year after start of treatment|||Percentage of LVEF||Standard Deviation|Mean
712559|NCT00203502|Secondary|Percentage of Participants With Grade 3 or 4 Adverse Events|Percent of participants who had at least one grade 3 or 4 adverse event|After each chemotherapy infusion, approximately one hour|||percentage of pts w/ grade 3/4 AE||90% Confidence Interval|Number
712560|NCT00203502|Secondary|Number of Participants With Clinical Complete Response in Breast and the Axillary Lymph Nodes After the Completion of Chemotherapy and Bevacizumab.|Clinical complete response was defined using RECIST response categories as the clinical response to chemotherapy|At completion of chemotherapy treatment, an average of one hour|All participants evaluated surgically||percentage of pts w/ cCR||90% Confidence Interval|Number
712561|NCT00203502|Primary|Percentage of Participants With Pathological Complete Response.|Pathological complete response was defined as the absence of residual invasive and in situ cancer on hematoxylin and eosin evaluation of the resected breast.|Participants were assessed during surgery, an average of one hour|||percentage of evaluable patients||90% Confidence Interval|Number
712562|NCT00203892|Secondary|Evidence of Dose Limiting Toxicities of Immunization With Modified CEA (Carcinoembryonic Antigen) Peptide.|Dose-limited toxicity included Grade 2 or higher hemorrhage or allergic reaction or clinical evidence of autoimmune disease. Toxicities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v2.0.|participants were followed while they were on study treatment, a median of 8 weeks|||participants|||Number
712563|NCT00203892|Primary|Maximum T Cell Response From Baseline|"T cell frequency (spots per 10^4 CD8+ cells) was measured by ELISPOT (Enzyme-linked immunosorbent spot) assay. Blood was collected for this assay at baseline and every 4 weeks for the first 8 cycles. After the eighth cycle, a blood sample was collected at the time of disease progression. The maximum T cell response was calculated as: peak value on treatment - baseline value.
A positive value indicates an increase from baseline."|baseline and every 4 weeks on treatment|The analysis population for the primary outcome included the 14 patients who received at least 3 doses of the CEA vaccine and had a ELISPOT at least at baseline and after the 3rd cycle.||spots per 10^4 CD8+ cells||Full Range|Median
712575|NCT00203996|Primary|Aim 2: Acute Insulin Resistance to Intravenous Glucose (AIRg) [Baseline]|Acute insulin resistance to intravenous glucose (AIRg) is a measure of the secretion of insulin during the first 10 minutes after an intravenous glucose load. AIRg addresses adequacy of insulin secretion.|baseline (0 weeks)|The recruitment of control subjects for this protocol was hindered by the difficulty in finding subjects who met both inclusion and exclusion criteria. As a consequence, the sample size of control subjects was insufficient to allow for any meaningful conclusions to be drawn. Statistical analyses were not possible due to insufficient sample size.||mU/(liter x min)||Standard Error|Mean
712564|NCT00203931|Secondary|Progression-free Survival Based on Serum Biomarker Status|Progression-free survival in this analysis looking at the association between a serum proteomic biomarker and progression-free survival will be defined as the time from the start of treatment until progression (documented according to Response Evaluation Criteria in Solid Tumors [RECIST] criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions) or death from any cause, whichever comes first.|up to 5 years|Includes evaluable patients (those that received at least 3 doses of cetuximab), but the total number analyzed is not 43 because 10 patients did not have a pre-treatment/baseline serum marker classification and thus were excluded from this analysis.||months||95% Confidence Interval|Median
712565|NCT00203931|Secondary|Overall Survival|Overall survival will be defined as the time from the start of treatment until death from any cause.|Up to 5 years|Includes evaluable patients (those that received at least 3 doses of cetuximab)||months||95% Confidence Interval|Median
712566|NCT00203931|Secondary|Objective Response Rate|Objective response (complete response [CR] + partial response [PR]) will be evaluated using RECIST criteria. CR is the disappearance of all target lesions. PR requires at least a 30% decrease in the sum of the longest diameter of target lesions.|up to 2 years|Includes evaluable patients (those that received at least 3 doses of cetuximab).||percentage of participants||95% Confidence Interval|Number
712567|NCT00203931|Secondary|Progression-free Survival Based on Rash Development|Progression-free survival in this landmark analysis looking at the utility of early rash in predicting progression-free survival will be defined as the time from day 22 of study therapy until progression (documented according to Response Evaluation Criteria in Solid Tumors [RECIST] criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions) or death from any cause, whichever comes first. Patients last known to be alive and progression-free were censored at the date of the last scan without evidence of progression.|up to 5 years|Includes evaluable patients (those that received at least 3 doses of cetuximab), but the total number analyzed is not 43 because 2 patients died or progressed prior to day 22 of cetuximab therapy and thus were excluded from this analysis.||months||Standard Error|Median
712568|NCT00203931|Primary|Progression-free Survival|Progression-free survival will be defined as the time from the start of treatment until progression (documented according to Response Evaluation Criteria in Solid Tumors [RECIST] criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions) or death from any cause, whichever comes first.|Up to 5 years|Includes evaluable patients (those that received at least 3 doses of cetuximab)||months||95% Confidence Interval|Median
712569|NCT00203996|Primary|Aim 3: Insulin Sensitivity Index (SI) From Intravenous Glucose Tolerance Test [After 3 Nights of SWS Suppression]|Insulin sensitivity Index (SI) is the increase in net fractional glucose clearance rate per unit change in plasma insulin concentration after an intravenous glucose load. SI quantifies the capacity of insulin to promote glucose disposal.|3 nights|Due to technical issues, REM fragmentation data were not analyzable. Technical issues also resulted in non-analyzable data for two subjects in the SWS suppression study, thereby decreasing the sample size from 11 to 9 subjects.||mU/(liter x min)||Standard Error|Mean
712570|NCT00203996|Primary|Aim 3: Insulin Sensitivity Index (SI) From Intravenous Glucose Tolerance Test [Baseline]|Insulin sensitivity Index (SI) is the increase in net fractional glucose clearance rate per unit change in plasma insulin concentration after an intravenous glucose load. SI quantifies the capacity of insulin to promote glucose disposal.|Baseline|Due to technical issues, REM fragmentation data were not analyzable. Technical issues also resulted in non-analyzable data for two subjects in the SWS suppression study, thereby decreasing the sample size from 11 to 9 subjects.||mU/(liter x min)||Standard Error|Mean
712571|NCT00203996|Secondary|Aim 2: Mean Leptin Levels Over 24 Hours, Per Patient [After Treatment]|This outcome is defined as the average concentration of leptin (a hormone produced by the fat cells that affects feeding behavior and appetite) in the blood, measured repeatedly over a 24 hour period in each patient individually.|15 minutes over a period of 24 hours|The recruitment of control subjects for this protocol was hindered by the difficulty in finding subjects who met both inclusion and exclusion criteria. As a consequence, the sample size of control subjects was insufficient to allow for any meaningful conclusions to be drawn. Statistical analyses were not possible due to insufficient sample size.||nanogram/milliliter||Standard Error|Mean
712572|NCT00203996|Secondary|Aim 2: Mean Leptin Levels Over 24 Hours, Per Patient [Baseline]|This outcome is defined as the average concentration of leptin (a hormone produced by the fat cells that affects feeding behavior and appetite) in the blood, measured repeatedly over a 24 hour period in each patient individually.|15 minutes over a period of 24 hours|The recruitment of control subjects for this protocol was hindered by the difficulty in finding subjects who met both inclusion and exclusion criteria. As a consequence, the sample size of control subjects was insufficient to allow for any meaningful conclusions to be drawn. Statistical analyses were not possible due to insufficient sample size.||nanogram/milliliter||Standard Error|Mean
712573|NCT00203996|Secondary|Aim 2: Mean Cortisol Levels Over 24 Hours, Per Patient [After Treatment]|This outcome is defined as the average concentration of cortisol (a glucocorticoid produced by the adrenal gland) in the blood, measured repeatedly over a 24 hour period in each patient individually.|10 minutes, over a period of 24 hours|The recruitment of control subjects for this protocol was hindered by the difficulty in finding subjects who met both inclusion and exclusion criteria. As a consequence, the sample size of control subjects was insufficient to allow for any meaningful conclusions to be drawn. Statistical analyses were not possible due to insufficient sample size.||microgram/deciliter||Standard Error|Mean
712574|NCT00203996|Primary|Aim 2: Acute Insulin Resistance to Intravenous Glucose (AIRg) [After CPAP]|Acute insulin resistance to intravenous glucose (AIRg) is a measure of the secretion of insulin during the first 10 minutes after an intravenous glucose load. AIRg addresses adequacy of insulin secretion.|8 weeks|The recruitment of control subjects for this protocol was hindered by the difficulty in finding subjects who met both inclusion and exclusion criteria. As a consequence, the sample size of control subjects was insufficient to allow for any meaningful conclusions to be drawn. Statistical analyses were not possible due to insufficient sample size.||mU/(liter x min)||Standard Error|Mean
712602|NCT00196937|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|During the 30-day (Days 0-29) period following each vaccination|||subjects|||Number
712576|NCT00203996|Secondary|Aim 2: Mean Cortisol Levels Over 24 Hours, Per Patient [Baseline]|This outcome is defined as the average concentration of cortisol (a glucocorticoid produced by the adrenal gland) in the blood, measured repeatedly over a 24 hour period in each patient individually.|10 minutes, over a period of 24 hours|The recruitment of control subjects for this protocol was hindered by the difficulty in finding subjects who met both inclusion and exclusion criteria. As a consequence, the sample size of control subjects was insufficient to allow for any meaningful conclusions to be drawn. Statistical analyses were not possible due to insufficient sample size.||microgram/deciliter||Standard Error|Mean
712577|NCT00203996|Secondary|Aim 1: Visceral Adiposity [After Treatment]|Visceral adiposity refers to the degree of fat located in the peritoneal cavity (abdominal area) that surrounds the body's internal organs.|up to half of an hour|No participants were randomized to this arm.|||||
712578|NCT00203996|Secondary|Aim 1: Visceral Adiposity [Baseline]|Visceral adiposity refers to the degree of fat located in the peritoneal cavity (abdominal area) that surrounds the body's internal organs.|up to half of an hour|No participants were randomized to this arm.|||||
712579|NCT00203996|Secondary|Aim 1: Blood Pressure [After Treatment]|Blood pressure is the pressure of blood within the arteries, produced primarily by the contraction of the heart muscle.|8 weeks|No participants were randomized to these study arms.|||||
712580|NCT00203996|Secondary|Aim 1: Blood Pressure [Baseline]|Blood pressure is the pressure of blood within the arteries, produced primarily by the contraction of the heart muscle.|baseline (0 weeks)|No participants were randomized to these study arms.|||||
712581|NCT00203996|Primary|Aim 2: Insulin Sensitivity Index (SI) From Intravenous Glucose Tolerance Test [After CPAP]|Insulin sensitivity Index (SI) is the increase in net fractional glucose clearance rate per unit change in plasma insulin concentration after an intravenous glucose load. SI quantifies the capacity of insulin to promote glucose disposal.|8 weeks|The recruitment of control subjects for this protocol was hindered by the difficulty in finding subjects who met both inclusion and exclusion criteria. As a consequence, the sample size of control subjects was insufficient to allow for any meaningful conclusions to be drawn. Statistical analyses were not possible due to insufficient sample size.||mU/(liter x min)||Standard Error|Mean
712582|NCT00203996|Primary|Aim 2: Insulin Sensitivity Index (SI) From Intravenous Glucose Tolerance Test [Baseline]|Insulin sensitivity Index (SI) is the increase in net fractional glucose clearance rate per unit change in plasma insulin concentration after an intravenous glucose load. SI quantifies the capacity of insulin to promote glucose disposal.|baseline (0 weeks)|The recruitment of control subjects for this protocol was hindered by the difficulty in finding subjects who met both inclusion and exclusion criteria. As a consequence, the sample size of control subjects was insufficient to allow for any meaningful conclusions to be drawn. Statistical analyses were not possible due to insufficient sample size.||mU/(liter x min)||Standard Error|Mean
712583|NCT00203996|Primary|Aim 1: Apnea-hypopnea Index (AHI) [After Treatment]|Apnea–hypopnea index (AHI) is an index used to assess the severity of sleep apnea based on the total number of complete cessations (apnea) and partial obstructions (hypopnea) of breathing occurring per hour of sleep.|8 weeks|No participants were randomized to these study arms.|||||
712584|NCT00203996|Primary|Aim 1: Apnea–Hypopnea Index (AHI) [Baseline]|Apnea–hypopnea index (AHI) is an index used to assess the severity of sleep apnea based on the total number of complete cessations (apnea) and partial obstructions (hypopnea) of breathing occurring per hour of sleep.|baseline|No participants were randomized to these study arms.|||||
712585|NCT00204373|Secondary|The Median Survival From the Time of Diagnosis.|The median survival from the time of diagnosis|survival or up to 240 months|||years||Standard Deviation|Median
712586|NCT00204373|Primary|Long-term Medical(Non-surgical)Control of Gastric Acid Production Assessed From Time of Study Enrollment, up to 240 Months Post Enrollment.|number of participants with control of gastric acid production|up to 240 months from study enrollment|||participants|||Number
712587|NCT00204932|Primary|Fat Mass|loss of fat mass, kg|6 months|||kg||Standard Deviation|Mean
712588|NCT00204932|Secondary|Total Fat Oxidation|Blood chemistries and general well being|6 months||||||
712589|NCT00205049|Primary|Survival at 28 Days||28 days|Study was terminated before any data was gathered/analyzed.|||||
712590|NCT00205374|Secondary|12-month Reduction in Voice Handicap Index (VHI) Score|"Voice Handicap Index. This scale rates a patient’s perception of voice related handicap in the domains of functional, physical, and emotional. There are 10 questions for each domain. Each question is rated by the subject on a 5-point scale, never =0, almost never =1, sometimes =2, almost always =3, always =4). A lower total score or domain score indicates improved, or less, voice handicap. Thus, the maximum total score is 4 X 30 = 120. For each domain, the maximum score is 4 X 10 = 40. Scores of 0 are the lowest possible score. In the paper we say that the Maximum score is 100, but obviously is it actually 120. Complete scale = 0-120.
Lower score indicates improved perceived voice-realted quality of life."|2 months and 12 months|||scores on a scale||Full Range|Mean
712591|NCT00205374|Primary|Change in Papilloma Severity|"Derkay Severity Score. Minimum Score is Zero. Maximum score is 86. Treatment of RRP with cidofovir injection will be considered efficacious if drug group patients experience clinically or statistically significant changes in papilloma severity and inter-surgery time intervals (relative to pre-treatment assessments), when compared with placebo group patients.
The scale rates - Voice (normal 0, abnormal 1, aphonic 2) Stridor (absent 0, present with activity 1, present at rest 2) Urgency of the intervention (scheduled 0, elective 1, urgent 2, emergent 3) Respiratory distress (none 0, mild 1, mod 2, severe 3, extreme 4).
For multiple anatomical sites (18 or more) in the upper airway, left and right sides, lesions are rated as 0=none, 1=surface lesion, 2=raised lesion, and 3=bulky lesion).
A higher rating value indicates more advanced disease and a worse outcome."|2 months and 12 months|||scores on a scale||Full Range|Mean
712603|NCT00196937|Secondary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed include arthralgia, fatigue, fever, gastrointestinal symptoms, headache, myalgia, rash, and urticaria.|During the 7-day (Days 0-6) period following each vaccination|Analysis was performed on the Total vaccinated cohort on subjects with a documented dose.||subjects|||Number
712604|NCT00196937|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling at the injection site.|During the 7-day (Days 0-6) period following each vaccination|Analysis was performed on the Total vaccinated cohort on subjects with a documented dose.||subjects|||Number
712592|NCT00196326|Primary|"Annualized Pregnancy Rate (Pearl Index) For 91-Day Cycles by Cohort Using up to 7 Days Post-Last Combination Dose When Defining On Drug Pregnancy"|"Pearl Index= ((100)*(number of pregnancies)*(4 cycles/year))/number of 91-day cycles completed.
The pregnancy rate included on-drug pregnancies, defined as those pregnancies for which the date of conception was on or after the date of first dose of study medication, but no more than 7 days after the date of last combination dose of study medication.
Pregnancy was defined as a positive pregnancy test verified by the study staff. The conception date was based on the ultrasound date. A pregnancy was not considered 'on drug' if conception clearly occurred prior to first dose of study medication, or more than 7 days after the date of last combination dose of study medication.
Three denominators are reported;
excluding cycles where other birth control methods (BCMs) was used
all complete cycles
compliant-use (i.e. subject did not skip two or more consecutive pills or had a pattern of substantial non-compliance, or used a prohibited concomitant medication)"|up to one year|The pregnancy intent-to-treat cohort (PITT) consisted of subjects between the ages of 18 and 35 who were randomized to treatment and completed at least one cycle of study medication.||pregnancies per 100 woman years exposure|||Number
712593|NCT00196326|Secondary|Participants With Treatment-Emergent Adverse Events|Safety was assessed by summarizing adverse events recorded in the patient's daily diary and reported by subjects at each study visit, and by summarizing results of examination, vital signs and clinical laboratory values.|Day 1 up to one year|The safety cohort consisted of all patient who took at least one dose of study medication||participants|||Number
712594|NCT00196326|Primary|"Annualized Pregnancy Rate (Pearl Index) For 91-Day Cycles by Cohort Using up to 14 Days Post-Last Combination Dose When Defining On Drug Pregnancy"|"Pearl Index= ((100)*(number of pregnancies)*(4 cycles/year))/number of 91-day cycles completed.
The pregnancy rate included on-drug pregnancies, defined as those pregnancies for which the date of conception was on or after the date of first dose of study medication, but no more than 14 days after the date of last combination dose of study medication.
Pregnancy was defined as a positive pregnancy test verified by the study staff. The conception date was based on the ultrasound date. A pregnancy was not considered 'on drug' if conception clearly occurred prior to first dose of study medication, or more than 14 days after the date of last combination dose of study medication.
Three denominators are reported;
excluding cycles where other birth control methods (BCMs) was used
all complete cycles
compliant-use (i.e. subject did not skip two or more consecutive pills or had a pattern of substantial non-compliance, or used a prohibited concomitant medication)"|up to one year|The pregnancy intent-to-treat cohort (PITT) consisted of subjects between the ages of 18 and 35 who were randomized to treatment and completed at least one cycle of study medication.||pregnancies per 100 woman years exposure|||Number
712595|NCT00196716|Secondary|Urine Globotriaosylceramide (GL-3)|Evaluated at Baseline, Week 24 and Week 96. Urine GL-3 is often elevated in the urine of patients diagnosed with Fabry disease. This outcome measure evaluated the mean urine GL-3 in first morning void urine for all patients to see if it decreased while on Fabrazyme. Normal Urine GL-3 threshold was < 8.8 μg/mg.|Throughout study, 96 weeks|ITT population. One patient switched back to 1.0 mg/kg Fabrazyme treatment at Week 76 and therefore assessments at Week 76 and thereafter for this patient were excluded from the analysis.||μg/mg||Standard Deviation|Mean
712596|NCT00196716|Secondary|Plasma Globotriaosylceramide (GL-3)|Evaluated at Baseline, Week 24, Week 48, Week 72 and Week 96. Plasma GL-3 is often elevated in the plasma of patients diagnosed with Fabry disease. This outcome measure evaluated the mean plasma GL-3 values for all patients to see if it decreased while on Fabrazyme. Normal plasma GL-3 level was <= 7.03 µg/mL.|Throughout study; 96 weeks|ITT population. One patient switched back to 1.0 mg/kg Fabrazyme treatment at Week 76 and therefore assessments at Week 76 and thereafter for this patient were excluded from the analysis.||μg/mL||Standard Deviation|Mean
712597|NCT00196716|Secondary|Estimated Glomerular Filtration Rate (eGFR)|Evaluated at Baseline, Week 24 and Week 96. eGFR is an estimation of the glomerular filtration rate of the kidneys (how much blood the kidneys are filtering). For this study, normal eGFR was defined as greater than 90 mL/min/1.73 m2|Throughout study; 96 weeks|ITT Population. One patient switched back to 1.0 mg/kg Fabrazyme treatment at Week 76 and therefore assessments at Week 76 and thereafter for this patient were excluded from the analysis.||ml/min/1.73 m2||Standard Deviation|Mean
712598|NCT00196716|Secondary|Skin Globotriaosylceramide (GL-3) Clearance From Superficial Skin Capillary Endothelium|Skin biopsies were taken at Baseline, Week 24, Week 48, Week 72, and Week 96 and analyzed for cellular GL-3 accumulation (inclusions) by light microscopy. Each biopsy was evaluated by pathologists for the total number of vessels with GL-3 accumulation on an inclusion severity score of 0 (none/trace), 1 (mild), 2 (moderate), and 3 (severe).|Throughout study ; 96 weeks|ITT Population. One patient switched back to 1.0 mg/kg Fabrazyme treatment at Week 76 and therefore assessments at Week 76 and thereafter for this patient were excluded from the analysis.||Participants|||Number
712599|NCT00196716|Primary|Globotriaosylceramide (GL-3) Clearance in Kidney Interstitial Capillary Endothelium|Kidney biopsies were taken at Baseline, Week 24, and Week 96 and analyzed for cellular GL-3 accumulation (inclusions) by light microscopy. Each biopsy was evaluated by pathologists for the total number of vessels with GL-3 accumulation on an inclusion severity score of 0 (none/trace), 1 (mild), 2 (moderate), and 3 (severe).|Throughout study; 96 weeks|Intent-to-Treat (ITT) Population. One patient switched back to 1.0 mg/kg Fabrazyme treatment at Week 76 and therefore assessments at Week 76 and thereafter for this patient were excluded from the analysis.||Participants|||Number
712600|NCT00196937|Secondary|Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSAEs)|NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes. MSAEs assessed include AEs prompting emergency room visits and physician office visits not related to common illnesses.|During the entire study period (up to Month 48)|Analysis was performed on the Total vaccinated cohort (for data up to Month 7) or on the Total vaccinated cohort of the extension follow-up phase (for the remaining data).||subjects|||Number
712601|NCT00196937|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|During the entire study period (up to Month 48)|Analysis was performed on the Total vaccinated cohort (for data up to Month 7) or on the Total vaccinated cohort of the extension follow-up phase (for the remaining data).||subjects|||Number
712605|NCT00196937|Secondary|Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies After 2 Vaccine Doses and 6 Months Following the Complete Vaccination Course|"Seroconversion is defined as the appearance of anti-HPV-16 and/or anti- HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination.
Cut-off values were 8 EL.U/mL for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.
Seroconversion results at Month 7 (1 month after the complete vaccination course) are already presented above as primary outcome measure #1 for Cervarix (15-25 Years) Group and Cervarix (26-45 Years) Group and as secondary outcome measure #6 for Cervarix (46-55 Years) Group."|At Month 2 and Month 12|Analysis was performed on initially seronegative subjects from the ATP cohort for analysis of immunogenicity.||subjects|||Number
712606|NCT00196937|Secondary|Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies, in Women 46 - 55 Years of Age|"Seroconversion is defined as the appearance of anti-HPV-16 and/or anti- HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination.
Cut-off values were 8 EL.U/mL for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.
Seroconversion results at Month 7 for the other 2 groups are already presented in the primary outcome measure #1."|At Month 7|Analysis was performed on initially seronegative subjects from the ATP cohort for analysis of immunogenicity with available data.||subjects|||Number
712607|NCT00196937|Secondary|Number of Subjects Seropositive for Total Immunoglobulin-G (IgG) in Blood (Serum) and in Cervical Samples (Secretion)|Seropositivity is defined as total IgG above or equal to 0 microgram per milliliter (µg/mL).|At Months 18 and 24|Analysis was performed on the Cervicovaginal samples subset cohort, including subjects for whom cervicovaginal secretion samples with less than 80 erythrocytes per milliliter were collected and results were available for Months 18 and/or 24.||subjects|||Number
712608|NCT00196937|Secondary|Titer of Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervical Samples|Titer given as GMT.|At Months 18 and 24|Analysis was performed on subjects from the Total vaccinated for whom cervical secretions results were available for Months 18 and/or 24.||EL.U/mL||95% Confidence Interval|Geometric Mean
712609|NCT00196937|Primary|Titer of Anti-HPV-16 and Anti-HPV-18 Antibodies|"Titer given as geometric mean titer (GMT).
Primary outcome measure assessed at Month 18, 24, 36, and 48."|Before vaccination (PRE) and at Months 2, 7, 12, 18, 24, 36 and 48|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available data at the defined timepoint.||EL.U/mL||95% Confidence Interval|Geometric Mean
712610|NCT00196937|Primary|Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies, in Women 15 to 25 Years of Age and Women 26 to 45 Years of Age|"Seroconversion is defined as the appearance of anti-HPV-16 and/or anti- HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination.
Cut-off values were 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.
Seroconversion at Month 7 was a secondary outcome measure as per protocol for Cervarix (46-55 Years) Group."|At Month 7|Analysis was performed on initially seronegative subjects from the According-to-Protocol (ATP) cohort for analysis of immunogenicity. Data for the Cervarix (46-55 Years) Group are presented in the Outcome #6.||subjects|||Number
712611|NCT00196976|Secondary|Number of Subjects With SAEs|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Since the last study contact in the primary study up to the end of the booster study (from Month 2 up to Month 13)|The analysis was performed on the Booster Total Vaccinated Cohort, which included all subjects who received the booster dose of Mencevax™ ACWY vaccine.||Participants|||Count of Participants
712612|NCT00196976|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the primary vaccination study (from Month 0 up to Month 2)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.||Participants|||Count of Participants
712613|NCT00196976|Secondary|Number of Subjects With Any Unsolicited AEs|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within 31 days (Days 0-30) after the booster vaccination|The analysis was performed on the Booster Total Vaccinated Cohort, which included all subjects who received the booster dose of Mencevax™ ACWY vaccine.||Participants|||Count of Participants
712614|NCT00196976|Secondary|Number of Subjects With Any Unsolicited AEs During the Primary Vaccination|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within 31 days (Days 0-30) post-vaccination with diphteria, tetanus and acellular pertusis-containing vaccine, during the primary vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.||Participants|||Count of Participants
712615|NCT00196976|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs) After the Primary Vaccination|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within 31 days (Days 0-30) after the primary meningococcal vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.||Participants|||Count of Participants
712748|NCT00197496|Primary|Feasibility - # With > or = 60% Compliance, # Agreeing to Participate, # Returning for 3 Month Follow-up|Compliance to BWSTT only,|3 months|||Participants|||Count of Participants
712616|NCT00196976|Secondary|Number of Subjects With Any Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, fever [defined as rectal temperature equal to or above 38.0 degrees Celsius (°C)], irritability and loss of appetite. Any = incidence of a particular symptom regardless of intensity or relationship to vaccination.|During the 8-day (Days 0-7) post-vaccination period following booster dose|The analysis was performed on the Booster Total Vaccinated Cohort, which included all subjects who received the booster dose of Mencevax™ ACWY vaccine and had the symptom sheets filled in.||Participants|||Count of Participants
712617|NCT00196976|Secondary|Number of Subjects With Any Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.|During the 8-day (Days 0-7) post-vaccination period following booster dose|The analysis was performed on the Booster Total Vaccinated Cohort, which included all subjects who received the booster dose of Mencevax™ ACWY vaccine and had the symptom sheets filled in.||Participants|||Count of Participants
712618|NCT00196976|Secondary|Antibody Concentrations Against Different Meningococcal Polysaccharides|The meningococcal polysaccharides assessed included polysaccharide A (anti-PSA), polysaccharide B (anti-PSB), polysaccharide W-135 (anti-PSW-135) and polysaccharide Y (anti-PSY). Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).|Before (PRE= at Month 12) and one month after (at Month 13) booster vaccination|The analysis was performed on the According-to-Protocol (ATP) Cohort for immune memory, which included subjects in the Toddlers subgroup from the ATP cohort for persistence, for whom assay results were available for antibodies against at least one study vaccine antigen component for the post-booster dose blood sampling.||μg/mL||95% Confidence Interval|Geometric Mean
712619|NCT00196976|Secondary|Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Polysaccharides|A seropositive subject for anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY was defined as a vaccinated subject with antibody concentrations greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL), while for a seroprotected subject, antibody concentrations were ≥ 2.0 μg/mL.|Before (PRE= at Month 12) and one month after (at Month 13) booster vaccination|The analysis was performed on the According-to-Protocol (ATP) Cohort for immune memory, which included subjects in the Toddlers subgroup from the ATP cohort for persistence, for whom assay results were available for antibodies against at least one study vaccine antigen component for the post-booster dose blood sampling.||Participants|||Count of Participants
712620|NCT00196976|Secondary|Antibody Titers Against Different Meningococcal Serogroups|Antibody titers against meningococcal serogroups A, C, W-135 and Y (MenA, MenC, MenW-135 and MenY) have been assessed, using rabbit complement and expressed as geometric mean titers (GMTs).|Before (PRE= at Month 12) and one month after (at Month 13) booster vaccination|The analysis was performed on the According-to-Protocol (ATP) Cohort for immune memory, which included subjects in the Toddlers subgroup from the ATP cohort for persistence, for whom assay results were available for antibodies against at least one study vaccine antigen component for the post-booster dose blood sampling.||Titers||95% Confidence Interval|Geometric Mean
712621|NCT00196976|Secondary|Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Serogroups|A seropositive subject for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY was defined as a vaccinated subject with antibody titers greater than or equal to (≥) 1:128, while for a seroprotected subject, titers were ≥1:8.|Before (PRE= at Month 12) and one month after (at Month 13) booster vaccination|The analysis was performed on the According-to-Protocol (ATP) Cohort for immune memory, which included subjects in the Toddlers subgroup from the ATP cohort for persistence, for whom assay results were available for antibodies against at least one study vaccine antigen component for the post-booster dose blood sampling.||Participants|||Count of Participants
712622|NCT00196976|Secondary|Antibody Concentrations Against Different Meningococcal Polysaccharides|The meningococcal polysaccharides assessed included polysaccharide A (anti-PSA), polysaccharide B (anti-PSB), polysaccharide W-135 (anti-PSW-135) and polysaccharide Y (anti-PSY). Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).|At one month (M1) and 12 months (M12) post-primary vaccination|The analysis was performed on the According-to-Protocol (ATP) Cohort for antibody persistence, which included subjects primed with the selected GSK134612A formulation or the control vaccine in both age strata, for whom assay results were available for antibodies against at least one study vaccine antigen component for the Month 12 blood sampling.||µg/mL||95% Confidence Interval|Geometric Mean
712623|NCT00196976|Secondary|Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides|A seroprotected subject for meningococcal polysaccharide A (PSA), C (PSC), W-135 (PSW-135) and Y (PSY) assessed, was defined as having antibody (anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY) concentrations greater than or equal to (≥) the value of 2.0 micrograms per milliliter (μg/mL). Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA).|At one month (M1) and 12 months (M12) post primary vaccination|The analysis was performed on the According-to-Protocol (ATP) Cohort for antibody persistence, which included subjects primed with the selected GSK134612A formulation or the control vaccine in both age strata, for whom assay results were available for antibodies against at least one study vaccine antigen component for the Month 12 blood sampling.||Participants|||Count of Participants
712624|NCT00196976|Secondary|Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides|A seropositive subject for meningococcal polysaccharide A (PSA), C (PSC), W-135 (PSW-135) and Y (PSY) assessed, was defined as having antibody (anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY) concentrations greater than or equal to (≥) the cut-off value of 0.3 micrograms per milliliter (μg/mL). Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA).|At one month (M1) and 12 months (M12) post-primary vaccination|The analysis was performed on the According-to-Protocol (ATP) Cohort for antibody persistence, which included subjects primed with the selected GSK134612A formulation or the control vaccine in both age strata, for whom assay results were available for antibodies against at least one study vaccine antigen component for the Month 12 blood sampling.||Participants|||Count of Participants
712749|NCT00198029|Secondary|Visual Analog Scale for Pain|The visual analog scale for pain (VAS) is a test requiring a patient to indicate along a line how much pain they are experiencing between 0-100. A score of 100 indicates the maximum possible pain level and a score of 0 indicates no pain. Scores are recorded as whole number integers. The change in VAS (delta) over those 6 months was recorded.|26 weeks (6 months)|||mm||Standard Deviation|Mean
712625|NCT00196976|Secondary|Antibody Titers Against Different Meningococcal Serogroups|Antibody titers against meningococcal serogroups A, C, W-135 and Y (MenA, MenC, MenW-135 and MenY) have been assessed, using rabbit complement and expressed as geometric mean titers (GMTs).|At one month (M1) and 12 months (M12) post-primary vaccination|The analysis was performed on the According-to-Protocol (ATP) Cohort for antibody persistence, which included subjects primed with the selected GSK134612A formulation or the control vaccine in both age strata, for whom assay results were available for antibodies against at least one study vaccine antigen component for the Month 12 blood sampling.||Titers||95% Confidence Interval|Geometric Mean
712626|NCT00196976|Secondary|Number of Seropositive Subjects for Different Anti-meningococcal Serogroups|A seropositive subject for meningococcal serogroups rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-Y assessed, was defined as having antibody titers greater than or equal to (≥) 1:128.|At one month (M1) and 12 months (M12) post-primary vaccination|The analysis was performed on the According-to-Protocol (ATP) Cohort for antibody persistence, which included subjects primed with the selected GSK134612A formulation or the control vaccine in both age strata, for whom assay results were available for antibodies against at least one study vaccine antigen component for the Month 12 blood sampling.||Participants|||Count of Participants
712627|NCT00196976|Secondary|Number of Seroprotected Subjects Against Different Meningococcal Serogroups|A seroprotected subject against meningococcal serogroups rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY assessed, was defined as having antibody titers greater than or equal to (≥) 1:8.|At one month (M1) and 12 months (M12) post-primary vaccination|The analysis was performed on the According-to-Protocol (ATP) Cohort for antibody persistence, which included subjects primed with the selected GSK134612A formulation or the control vaccine in both age strata, for whom assay results were available for antibodies against at least one study vaccine antigen component for the Month 12 blood sampling.||Participants|||Count of Participants
712628|NCT00196976|Secondary|Number of Children With Any Solicited General Symptoms|The children subgroup received one primary meningococcal vaccine dose. Assessed solicited general symptoms included drowsiness, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = incidence of a particular symptom regardless of intensity or relationship to vaccination.|During the 8-day (Days 0-7) post-vaccination period after each primary vaccine dose|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had filled in the symptom sheets.||Participants|||Count of Participants
712629|NCT00196976|Secondary|Number of Toddlers With Any Solicited General Symptoms|The toddlers subgroup received 2 primary vaccine doses, as follows: first dose of a meningococcal vaccine and second dose of a diphtheria, tetanus and acellular pertusis-containing vaccine. Assessed solicited general symptoms included drowsiness, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = incidence of a particular symptom regardless of intensity or relationship to vaccination.|During the 8-day (Days 0-7) post-vaccination period after each primary vaccine dose|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had filled in the symptom sheets.||Participants|||Count of Participants
712630|NCT00196976|Secondary|Number of Children With Any Solicited Local Symptoms|The children subgroup received one dose of the meningococcal vaccine. Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.|During the 8-day (Days 0-7) post-vaccination period after each primary vaccine dose|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had filled in the symptom sheets.||Participants|||Count of Participants
712631|NCT00196976|Secondary|Number of Toddlers With Any Solicited Local Symptoms|The toddlers subgroup received 2 primary vaccine doses, as follows: first dose of a meningococcal vaccine and second dose of a diphtheria, tetanus and acellular pertusis-containing vaccine. Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.|During the 8-day (Days 0-7) post-vaccination period after each primary vaccine dose|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who had filled in the symptom sheets.||Participants|||Count of Participants
712632|NCT00196976|Secondary|Antibody Concentrations Against Tetanus (Anti-T)|Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) method, presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL).|Prior to (Month 0) and one month after (Month 1) the first vaccine dose|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.||IU/mL||95% Confidence Interval|Geometric Mean
712633|NCT00196976|Secondary|Number of Seropositive Subjects for Anti-tetanus (Anti-T)|A seropositive subject for anti-tetanus was defined as having antibody concentrations greater than or equal to (≥) the cut-off value of 0.1 international units per milliliter (IU/mL). Antibody titers were determined by enzyme-linked immunosorbent assay (ELISA).|Prior to (Month 0) and one month after (Month 1) the first vaccine dose|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.||Participants|||Count of Participants
712634|NCT00196976|Secondary|Antibody Concentrations Against Different Meningococcal Polysaccharides|The meningococcal polysaccharides assessed included polysaccharide A (anti-PSA), polysaccharide B (anti-PSB), polysaccharide W-135 (anti-PSW-135) and polysaccharide Y (anti-PSY). Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).|Prior to (Month 0) and one month after (Month 1) the first vaccine dose|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.||μg/mL||95% Confidence Interval|Geometric Mean
712635|NCT00196976|Secondary|Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides|A seroprotected subject for meningococcal polysaccharide A (PSA), C (PSC), W-135 (PSW-135) and Y (PSY) assessed, was defined as having antibody (anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY) concentrations greater than or equal to (≥) the value of 2.0 micrograms per milliliter (μg/mL). Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA).|Prior to (Month 0) and one month after (Month 1) the first vaccine dose|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.||Participants|||Count of Participants
712636|NCT00196976|Secondary|Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides|A seropositive subject for meningococcal polysaccharide A (PSA), C (PSC), W-135 (PSW-135) and Y (PSY) assessed, was defined as having antibody (anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY) concentrations greater than or equal to (≥) the cut-off value of 0.3 micrograms per milliliter (μg/mL). Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA).|Prior to (Month 0) and one month after (Month 1) the first vaccine dose|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.||Participants|||Count of Participants
712637|NCT00196976|Secondary|Antibody Titers Against Different Meningococcal Serogroups|Antibody titers against meningococcal serogroups A, C, W-135 and Y (MenA, MenC, MenW-135 and MenY) have been assessed, using rabbit complement and expressed as geometric mean titers (GMTs).|Prior to (Month 0) and one month after (Month 1) the first vaccine dose|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.||Titers||95% Confidence Interval|Geometric Mean
712638|NCT00196976|Secondary|Number of Seropositive Subjects for Different Anti-meningococcal Serogroups|A seropositive subject for meningococcal serogroups rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-Y assessed, was defined as having antibody titers greater than or equal to (≥) 1:128.|Prior to (Month 0) and one month after (Month 1) after the first vaccine dose|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.||Participants|||Count of Participants
712639|NCT00196976|Secondary|Number of Seroprotected Subjects Against Different Meningococcal Serogroups|A seroprotected subject against meningococcal serogroups rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY assessed, was defined as having antibody titers greater than or equal to (≥) 1:8.|Prior to (Month 0) and one month after (Month 1) the first vaccine dose|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.||Participants|||Count of Participants
712640|NCT00196976|Primary|Number of Subjects With an Immune Response to Different Meningococcal Serogroups|A responder to serum bactericidal assay meningococcal serogroups A, C, W and Y, using rabbit complement (rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY) was defined as follows: -for initially seronegative subjects (antibody titers < 1:8 for rSBA-Men), a subject achieving a post-vaccination rSBA-Men antibody titer of ≥ 1:32; - for initially seropositive subjects (antibody titers ≥ 1:8 for rSBA-Men), a subject having a ≥ 4-fold increase in rSBA-Men antibody titer from pre to post vaccination.|One month after the first vaccine dose (Month 1)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.||Participants|||Count of Participants
712641|NCT00197002|Secondary|Number of Subjects With SAEs, NCIs and MSEs|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. NCIs include autoimmune disorders, asthma, type I diabetes, allergies. MSEs include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|During the Extended Safety Follow-up (ESFU) Phase (from Day 30 to 6 months after final vaccine dose)|The analysis was performed on the ESFU cohort, which included all vaccinated subjects for whom safety data were available during the extended safety follow-up period (from Day 30 up to 6 months after last vaccine dose).||Subjects|||Number
712642|NCT00197002|Secondary|Number of Subjects With Serious Adverse Events (SAEs), New Chronic Illnesses (NCIs) and Medically Significant Events (MSEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. NCIs include autoimmune disorders, asthma, type I diabetes, allergies. MSEs include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|During the Active Phase (from Day 0 to Day 30 after final vaccine dose for each subject)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine administration documented.||Subjects|||Number
712643|NCT00197002|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 31-day (Day 0-30) follow-up period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine administration documented.||Subjects|||Number
712644|NCT00197002|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Grade 3 irritability = crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = not eating at all. Related = symptom assessed by the investigator as related to the vaccination.|During the 4-day (Day 0-3) follow-up period after each vaccine dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine administration documented and with the symptoms sheet filled in.||Subjects|||Number
712645|NCT00197002|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.|During the 4-day (Day 0-3) follow-up period after each vaccine dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine administration documented and with the symptoms sheet filled in.||Subjects|||Number
712646|NCT00197002|Secondary|Number of Subjects With Vaccine Response to Anti-HAV Antibodies|"The vaccine response was defined as:
a detectable anti-HAV antibody concentration one month after Dose 2 in subjects who were initially seronegative (antibody concentrations < 15 mIU/mL for anti-HAV); or
a 2-fold increase above the pre-vaccination concentration one month after Dose 2 in subjects who were initially seropositive (antibody concentrations ≥ 15 mIU/mL for anti-HAV)."|One month after Dose 2 of Havrix® vaccine (Month 7-10/8-10)|The analysis was performed on the ATP cohort for immunogenicity, which included all vaccinated subjects for whom immunogenicity data were available and who complied with the eligibility criteria as defined in the protocol.||Subjects|||Number
712647|NCT00197002|Secondary|Concentrations for Anti-HAV Antibodies|Anti-HAV antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli international units per milliliter (mIU/mL).|At one month after Dose 2 of Havrix® vaccine (Month 8-11)|The analysis was performed on the ATP Cohort for Immunogenicity, which included all vaccinated subjects for whom immunogenicity data were available and who complied with the eligibility criteria as defined in the protocol.||mIU/mL||95% Confidence Interval|Geometric Mean
712648|NCT00197002|Secondary|Number of Seropositive Subjects for Anti-HAV Antibodies|Cut-off values assessed were greater than or equal to (≥) 15 mIU/mL in the sera of subjects seronegative before vaccination.|At one month after Dose 2 of Havrix® vaccine (Month 8-11)|The analysis was performed on the ATP cohort for immunogenicity, which included all vaccinated subjects for whom immunogenicity data were available and who complied with the eligibility criteria as defined in the protocol.||Subjects|||Number
712649|NCT00197002|Secondary|Concentrations for Anti-HAV Antibodies|Anti-HAV antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli international units per milliliter (mIU/mL).|At one month after Dose 1 of Havrix® vaccine (Day 30)|The analysis was performed on the ATP cohort for immunogenicity, which included all vaccinated subjects for whom immunogenicity data were available and who complied with the eligibility criteria as defined in the protocol.||mIU/mL||95% Confidence Interval|Geometric Mean
712650|NCT00197002|Secondary|Number of Seropositive Subjects for Anti-HAV Antibodies|Cut-off values assessed were greater than or equal to (≥) 15 mIU/mL in the sera of subjects seronegative before vaccination.|At one month after Dose 1 of Havrix® vaccine (Day 30)|The analysis was performed on the ATP cohort for immunogenicity, which included all vaccinated subjects for whom immunogenicity data were available and who complied with the eligibility criteria as defined in the protocol.||Subjects|||Number
712651|NCT00197002|Secondary|Number of Subjects With an Immune Response to Anti-pneumococcal Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F|The immune response was defined, with respect to anti-pneumococcal response rates, as an antibody concentration equal to or above (≥) 0.05 μg/mL.|At one month after Prevnar™ vaccination (Day 30)|The analysis was performed on the ATP cohort for immunogenicity, which included all vaccinated subjects for whom immunogenicity data were available and who complied with the eligibility criteria as defined in the protocol.||Subjects|||Number
712652|NCT00197002|Secondary|Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-19F and Anti-23F Antibody Concentrations|Antibody concentrations against pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F and 23F) are presented as geometric mean concentrations (GMCs), expressed in microgram per milliliter (μg/mL).|At one month after Prevnar™ vaccination (Day 30)|The analysis was performed on the ATP cohort for immunogenicity, which included all vaccinated subjects for whom immunogenicity data were available and who complied with the eligibility criteria as defined in the protocol.||μg/mL||95% Confidence Interval|Geometric Mean
712653|NCT00197002|Primary|Concentrations for Anti-HAV Antibodies|Anti-HAV antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).|At one month after Dose 2 of Havrix® vaccine (Month 7-10)|The analysis was performed on the ATP cohort for immunogenicity, which included all vaccinated subjects for whom immunogenicity data were available and who complied with the eligibility criteria as defined in the protocol.||mIU/mL||95% Confidence Interval|Geometric Mean
712654|NCT00197002|Primary|Number of Seropositive Subjects for Anti-HAV Antibodies|Cut-off values assessed were greater than or equal to (≥) 15 milli-international units per milliliter (mIU/mL) in the sera of subjects seronegative before vaccination.|At one month after Dose 2 of Havrix® vaccine (Month 7-10)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all vaccinated subjects for whom immunogenicity data were available and who complied with the eligibility criteria as defined in the protocol.||Subjects|||Number
712655|NCT00197015|Secondary|Number of Subjects Reporting Medically Significant Events|Medically significant events include, but are not limited to, diabetes, autoimmune disease, asthma, allergies and/or conditions prompting emergency room or physician office visits that are not related to well-child care, vaccination or common acute illnesses (e.g., upper respiratory infection, otitis media, pharyngitis, gastroenteritis, injury and visits for routine physical examination).|During the Active Phase (from Day 0 up to Day 31 after the second dose) and the Extended Safety Follow-up Phase of the study (from Day 31 after the second dose up to study end)|Analysis was performed on the Total Vaccinated cohort (for the Active Phase) and the Extended Safety Follow-up cohort (for the Extended Safety Follow-up Phase).||subjects|||Number
712656|NCT00197015|Secondary|Number of Subjects Reporting New Chronic Illnesses|New Chronic illnesses include autoimmune disorders, asthma, type I diabetes, allergies.|During the Active Phase (from Day 0 up to Day 31 after the second dose) and the Extended Safety Follow-up Phase of the study (from Day 31 after the second dose up to study end)|Analysis was performed on the Total Vaccinated cohort (for the Active Phase) and the Extended Safety Follow-up cohort (for the Extended Safety Follow-up Phase).||subjects|||Number
712657|NCT00197015|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the Active Phase (from Day 0 up to Day 31 after the second dose) and the Extended Safety Follow-up Phase of the study (from Day 31 after the second dose up to study end)|Analysis was performed on the Total Vaccinated cohort.||subjects|||Number
712658|NCT00197015|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms|During the 31-day period following each dose of vaccine|Analysis was performed on the Total Vaccinated cohort.||subjects|||Number
712659|NCT00197015|Primary|Number of Subjects With Vaccine Response for Anti-rubella Antibodies in HAV+MMR+V and MMR+V→HAV Groups|Vaccine response is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination. Cut-off value assessed include 10 milli-international units per milliliter (mIU/mL).|42 days following administration of M-M-R®II and VARIVAX®|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results from HAV+MMR+V and MMR+V→HAV groups.||subjects|||Number
712660|NCT00197015|Primary|Number of Subjects Seroconverted for Anti-measle, Anti-mumps and Anti-varicella Antibodies in HAV+MMR+V and MMR+V→HAV Groups|Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination. Cut-off values assessed include 150 milli-international units per milliliter (mIU/mL) for anti-measles antibodies, 28 Effective Dose 50 (ED50) for anti-mumps antibodies and 1:5 for anti-varicella antibodies.|42 days following the administration of M-M-R®II and VARIVAX®|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results from HAV+MMR+V and MMR+V→HAV groups.||subjects|||Number
712661|NCT00197015|Secondary|Number of Subjects Reporting Measles, Mumps, Rubella and Varicella Specific Solicited General Adverse Events|Specific adverse events assessed include papules, vesicles, crusts, parotid/salivary gland swelling and suspected signs of meningitis/febrile seizures.|During the 43-day period following each dose of vaccine|Analysis was performed on the Total Vaccinated cohort, on subjects from MMR+V→HAV and HAV+MMR+V groups.||subjects|||Number
712662|NCT00197015|Secondary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed include drowsiness, fever, irritability, loss of appetite and rash (general).|During the 4-day period following each dose of vaccine|Analysis was performed on the Total Vaccinated cohort, on subjects with available data.||subjects|||Number
712663|NCT00197015|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, rash (local), redness and swelling.|During the 4-day period following each dose of vaccine|Analysis was performed on the Total Vaccinated cohort, on subjects with available data.||subjects|||Number
712664|NCT00197015|Secondary|Number of Subjects With Vaccine Response to Havrix®|Vaccine response was defined as: 1) a detectable anti-hepatitis A virus (HAV) antibody concentration 31 days following the second dose in subjects who were initially seronegative; and 2) a 2-fold increase in anti-HAV antibody concentrations above the pre-study concentration 31 days following the second dose in subjects who were initially seropositive.|31 days following the second dose of Havrix®|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.||subjects|||Number
712665|NCT00197015|Secondary|Number of Subjects With Anti-hepatitis A Virus (HAV) Antibody Concentrations Above the Cut-off Value in MMR+V→HAV Group|Anti-HAV antibody cut-off value assessed include 15 milli-international units per millilitre (mIU/mL).|31 days following the second dose of Havrix®|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results from MMR+V→HAV Group.||subjects|||Number
712666|NCT00197015|Secondary|Anti-hepatitis A Virus (HAV) Antibody Concentrations in MMR+V→HAV Group|Concentrations are given as geometric mean concentrations (GMCs).|31 days following the second dose of Havrix®|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results from MMR+V→HAV Group.||milli-international units per milliliter||95% Confidence Interval|Geometric Mean
712667|NCT00197015|Secondary|Number of Subjects With Anti-hepatitis A Virus (HAV) Antibody Concentration Equal or Above the Cut-off Value in HAV and HAV+MMR+V Groups|Anti-HAV antibody cut-off value assessed include 15 milli-international units per millilitre (mIU/mL).|42 days following the first dose of Havrix®|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results from HAV and HAV+MMR+V groups.||subjects|||Number
712668|NCT00197015|Secondary|Anti-hepatitis A Virus (HAV) Antibody Concentrations in HAV and HAV+MMR+V Groups|Concentrations are given as geometric mean concentrations (GMCs).|42 days following the first dose of Havrix®|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results from HAV and HAV+MMR+V groups.||milli-international units per milliliter||95% Confidence Interval|Geometric Mean
712669|NCT00197015|Secondary|Anti-measles, Anti-mumps, Anti-rubella and Anti-varicella Antibody Titers in HAV+MMR+V and MMR+V→HAV Groups|Titers are given as geometric mean titers (GMTs).|42 days following the administration of M-M-R®II and VARIVAX®|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results from HAV+MMR+V and MMR+V→HAV groups.||titers||95% Confidence Interval|Geometric Mean
712670|NCT00197015|Primary|Number of Subjects With Anti-hepatitis A Virus (HAV) Antibody Concentration Equal or Above the Cut-off Value in HAV and HAV+MMR+V Groups|Anti-HAV antibody cut-off value assessed include 15 milli-international units per milliliter (mIU/mL).|31 days following the second dose of Havrix®|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results from HAV and HAV+MMR+V groups.||subjects|||Number
712671|NCT00197015|Primary|Anti-hepatitis A Virus (HAV) Antibody Concentrations in HAV and HAV+MMR+V Groups.|Concentrations are given as geometric mean concentrations (GMCs) expressed as milli-international units per milliliter (mIU/mL).|31 days following the second dose of Havrix®|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results from HAV and HAV+MMR+V Groups.||mIU/mL||95% Confidence Interval|Geometric Mean
712672|NCT00197028|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs).|An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 30 day (Days 0-29) follow-up period after vaccination with Dose 3 of Engerix-B® or RTS,S/AS02D vaccine.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available, and whose symptom sheet was completed.||subjects|||Number
712673|NCT00197028|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs).|An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 14 day (Days 0-13) follow-up period after vaccination with any among Doses 1 and 2 of Engerix-B® or RTS,S/AS02D vaccine.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available, and whose symptom sheet was completed.||subjects|||Number
712674|NCT00197028|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs).|An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 14 day (Days 0-13) follow-up period after any vaccination with of TETRActHib™ vaccine|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available, and whose symptom sheet was completed.||subjects|||Number
712675|NCT00197028|Secondary|Number of Subjects With Solicited General Symptoms.|Assessed solicited general symptoms were drowsiness, fever, irritability and loss of appetite. Fever was defined as axillary temperature equal or above (≥) to 37.5 degrees Celsius (C).|During the 7 day (Days 0-6) follow-up period after any vaccination with Engerix-B® or RTS,S/AS02D vaccine|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available, and whose symptom sheet was completed.||subjects|||Number
712676|NCT00197028|Secondary|Number of Subjects With Solicited General Symptoms.|Assessed solicited general symptoms were drowsiness, fever, irritability and loss of appetite. Fever was defined as axillary temperature equal or above (≥) to 37.5 degrees Celsius (C).|During the 7 day (Days 0-6) follow-up period after any vaccination with TETRActHib™ vaccine|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available, and whose symptom sheet was completed.||subjects|||Number
712677|NCT00197028|Secondary|Number of Subjects With Solicited Local Symptoms.|Assessed solicited local symptoms were pain and swelling at injection site.|During the 7 day (Days 0-6) follow-up period after any vaccination with Engerix-B® or RTS,S/AS02D vaccine.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available, and whose symptom sheet was completed.||subjects|||Number
712678|NCT00197028|Secondary|Number of Subjects With Solicited Local Symptoms.|Assessed solicited local symptoms were pain and swelling at injection site.|During the 7 day (Days 0-6) follow-up period after any vaccination with TETRActHib™ vaccine.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available, and whose symptom sheet was completed.||subjects|||Number
712679|NCT00197028|Secondary|Plasmodium Falciparum (P. Falciparum) Parasite Density in Subjects Prevalent for Parasitemia|The parasite density in subjects prevalent for P. falciparum parasitemia (subjects with the presence of P. falciparum asexual parasitemia above 0 per microliter (µL) on Giemsa stained thick blood films), was detected at a cross sectional time point 3 ½ months after administration of Dose 3 of RTS,S/AS02D or Engerix-B® vaccine (Month 6). Parasite density is expressed as mean, minimum and maximum density in parasite per µL.|At Month 6 (3½ months post Dose 3 of RTS,S/AS02D or Engerix-B® vaccine)|The analysis was performed on the According-to-Protocol cohort for efficacy, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning efficacy outcome variables were available.||Parasites per µL||Full Range|Mean
712680|NCT00197028|Secondary|Number of Subjects Prevalent for Plasmodium Falciparum (P. Falciparum)|Subjects prevalent for P. falciparum parasitemia were defined as subjects with the presence of P. falciparum asexual parasitemia above 0 per microliter (µL) on Giemsa stained thick blood films.|At Month 6 (3½ months post Dose 3 of RTS,S/AS02D or Engerix-B® vaccine)|The analysis was performed on the According-to-Protocol cohort for efficacy, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning efficacy outcome variables were available.||subjects|||Number
712681|NCT00197028|Secondary|Time to First Malaria Infection|Malaria infection by Plasmodium falciparum (P. falciparum) was detected by active detection of infection (ADI) and passive case detection (PCD), and was defined as the presence of P. falciparum asexual parasitemia above 0 per microliter (µL) on Giemsa stained thick blood films. The time to first malaria infection is expressed in terms of rate of first malaria infection, that is, the number of malaria infection events reported (n) over the period elapsed until the event occurred (i.e. events per Persons Year at Risk [PYAR]) for each group.|Over the period starting 14 days after Dose 3 of RTS,S/AS02D or Engerix-B® vaccine and extending for 12 weeks thereafter (from Month 2.5 to Month 6)|The analysis was performed on the According-to-Protocol cohort for efficacy, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning efficacy outcome variables were available.||n/PYAR|||Number
712707|NCT00197119|Primary|Number of Subjects With Anti-hepatitis A Virus (HAV) Antibody Concentrations Above the Cut-off Value|Anti-HAV antibody concentration cut-off value assessed was ≥ 15 milli-International Units per milliliter (mIU/mL).|Year 6, 7, 8, 9 and 10 after the first vaccine dose of a two-dose or three-dose primary vaccination|Analysis was performed on the Long Term According To Protocol (ATP) cohort for immunogenicity, which included all subjects for whom serology results were available for a particular blood sampling visit.||subjects|||Number
712682|NCT00197028|Secondary|Concentrations of Anti-polyribosyl Ribitol Phosphate Antibodies (Anti-PRP).|Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per milliliter (µg/mL). The seroprotection cut-off of the assay was 0.15 µg/mL.|At Day 90 (1 month post Dose 3 of TETRActHib™ vaccine)|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.||µg/mL||95% Confidence Interval|Geometric Mean
712683|NCT00197028|Secondary|Concentrations of Anti-Bordetella Pertussis Toxin Antibodies (Anti-BPT).|Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EL.U/mL). The seropositivity cut-off of the assay was 15 EL.U/mL.|At Day 90 (1 month post Dose 3 of TETRActHib™ vaccine)|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
712684|NCT00197028|Secondary|Concentrations of Antibodies Against Tetanus (Anti-T)|Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in international unit per milliliter (IU/mL). The seroprotection cut-off of the assay was 0.1 IU/mL.|At Day 90 (1 month post Dose 3 of TETRActHib™ vaccine)|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.||IU/mL||95% Confidence Interval|Geometric Mean
712685|NCT00197028|Secondary|Concentrations of Antibodies Against Anti-diphtheria (Anti-D)|Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in international unit per milliliter (IU/mL). The seroprotection cut-off of the assay was 0.1 IU/mL.|At Day 90 (1 month post Dose 3 of TETRActHib™ vaccine)|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.||IU/mL||95% Confidence Interval|Geometric Mean
712686|NCT00197028|Secondary|Concentrations of Anti-circumsporozoite Protein (Anti-CS) Antibodies.|Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations are expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EL.U/mL). The seropositivity cut-off of the assay was 0.5 EL.U/mL.|Prior to vaccination at Month 0 (PRE), 1 month post Dose 3 of Engerix-B® or RTS,S/AS02D vaccine (Day 104) and 3½ months post Dose 3 of Engerix-B® or RTS,S/AS02D vaccine (Day 180).|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
712687|NCT00197028|Secondary|Concentrations of Antibodies Against Hepatitis B (Anti-HB)|Concentrations were expressed as geometric mean concentrations (GMCs) in milli-international unit per milliliter (mIU/mL). The seroprotection cut-off of the assay was 10 mIU/mL.|Prior to vaccination at Month 0 (PRE) and 1 month post Dose 3 of Engerix-B® or RTS,S/AS02D vaccine (Day 104).|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.||mIU/mL||95% Confidence Interval|Geometric Mean
712688|NCT00197028|Secondary|Number of Subjects With Serious Adverse Events (SAEs).|SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.|Throughout the entire study period (from Month 0 to Month 14)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||subjects|||Number
712689|NCT00197028|Primary|Number of Subjects With Serious Adverse Events (SAEs).|SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.|From Month 0 to Month 6|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||subjects|||Number
712690|NCT00197106|Secondary|Time to Asthma Control, Defined as the Time to First ‘Good Controlled Week’ or ‘Maximum Controlled Week'|This outcome measure was not analyzed due to different insights after protocol finalization; it has become clear that the definition of good and maximal controlled weeks is not very distinctive and can therefore actually not be used.|26 weeks||||||
712691|NCT00197106|Secondary|Weekly Percentage of Participants With ‘Good Controlled Weeks’ and ‘Maximal Controlled Weeks’|This outcome measure was not analyzed due to different insights after protocol finalization; it has become clear that the definition of good and maximal controlled weeks is not very distinctive and can therefore actually not be used.|26 weeks||||||
712692|NCT00197106|Secondary|Cumulative Number of Symptom-free Weeks Until the End of Treatment|This outcome measure was not analyzed due to different insights after protocol finalization; it has become clear that the definition of good and maximal controlled weeks is not very distinctive and can therefore actually not be used.|26 weeks||||||
712693|NCT00197106|Secondary|Frequency of Asthma Exacerbations (Discriminated on Severity)|The frequency of asthma exacerbations (discriminated on severity) was not analyzed because of the low overall frequency.|26 weeks||||||
712694|NCT00197106|Secondary|Daily FEV1 and PEF Via the Electronic Peak Flow/FEV1 Meter (PIKO-1)|Daily FEV1 and PEF via the electronic pea kflow/FEV1 meter (PIKO-1) was not assessed because data from the peak flow meters could not be used for analysis.|26 weeks||||||
712695|NCT00197106|Secondary|Bronchial Hyperresponsiveness With PD20 AMP in Selected Centres|Bronchial hyperresponsiveness with PD20 AMP in selected centres was not analyzed, as this outcome measure was removed in a protocol amendment.|26 weeks||||||
712696|NCT00197106|Secondary|Mean Change From Baseline in Provocation Dose (PD20) Causing a 20% Fall in FEV1 at Week 26|PD20 was calculated by using increasing dosages of methacholine. The dosage that caused a 20% fall in FEV1 was used for analysis. The presented data are ratios (month 6/Baseline) of geometric mean PD20 values.|Baseline and Week 26|Per protocol (PP) population: participants of the Intent-to-Treat (ITT) Population (participants who had taken at least one dose of study medication) who completed the study without any major protocol violations. From this population, only participants who had measurements at both baseline and Week 26 have been used for analysis.||ratio||95% Confidence Interval|Log Mean
712697|NCT00197106|Secondary|Number of Asthma Exacerbations Per Treatment Group at Week 26|An exacerbation is defined as a worsening of the asthma complaints (commonly referred to as an asthma attack) and is reported by the participant experiencing the event. An exacerbation was verified by the use of asthma rescue medication.|Week 26|Intent-to-Treat (ITT) Population (participants who had taken at least one dose of study medication)||number of exacerbations|||Number
712698|NCT00197106|Secondary|Percent Change From Baseline in RINT Measurements at Week 26|Change from Baseline was calculated as the Week 26 value minus the Baseline value. Interrupter respiratory resistance (RINT) measurements were calculated by a combined analysis for relation between change from baseline and occurrence of the endpoint. RINT is a technique that is used for evaluating lung function in poorly collaborating patients (e.g., small children). The measurement is performed during tidal breathing (normal breathing) instead of during maximal expiration, as is done by a spirometry test.|Baseline and Week 26|PP Population: Intent-to-Treat (ITT) Population participants who completed the study without any major protocol violations and completed two NO measurements (Baseline and Week 26). For some participants, the data for the RINT measurement are missing, either at Baseline or at Week 26. As a result, fewer subjects have been included in the analysis.||percent|||Number
712699|NCT00197106|Secondary|Geometric Means of Nitric Oxide (NO) at Week 26|Geometric mean values of NO at week 26 were compared using ANCOVA with adjustment for baseline value of NO, age, gender and center. Analysis of covariance (ANCOVA) is a general linear model with one continuous outcome variable (quantitative) and one or more factor variables.|Baseline and Week 26|Per protocol (PP) population: participants of the Intent-to-Treat (ITT) Population (participants who had taken at least one dose of study medication) who completed the study without any major protocol violations and completed two NO measurements (Baseline and Week 26)||parts per billion||Full Range|Geometric Mean
712700|NCT00197106|Secondary|Mean Change From Baseline in Midexpiratory Flow (MEF 50) at Week 26|Change from Baseline was calculated as the Week 26 value minus the Baseline value. MEF 50 is defined as maximum expiratory flow rate at 50% of vital capacity. Vital capacity is the maximum amount of air that a person can expel from the lungs after first filling the lungs to their maximum extent. Midexpiratory flow was calculated by use of spirometry. The test is normally repeated at least three times in order to ensure reproducibility.|Baseline and Week 26|Per protocol (PP) population: participants of the Intent-to-Treat (ITT) Population (participants who had taken at least one dose of study medication) who completed the study without any major protocol violations. For some participants, the data for the MEF 50 measurements are missing, resulting in a smaller number of participants analyzed.||liters/second||Standard Deviation|Mean
712701|NCT00197106|Secondary|Mean Change From Baseline in Forced Vital Capacity (FVC) at Week 26|Change from Baseline was calculated as the Week 26 value minus the Baseline value. Forced vital capacity is defined as the maximum volume of air that can be forcibly expired from the lungs and is calculated by use of spirometry. The spirometry test is performed by using a device called a spirometer, which measures the amount of air one can blow out maximally. Generally, the participant is asked to take the deepest breath they can, and then exhale into the sensor as hard as possible, for as long as possible. The test is normally repeated three times to ensure reproducibility.|Baseline and Week 26|Per protocol (PP) population: participants of the Intent-to-Treat (ITT) Population (participants who had taken at least one dose of study medication) who completed the study without any major protocol violations. At baseline there were 6 missing data and 4 improper testings that could not be used in the analysis.||liters||Standard Deviation|Mean
712702|NCT00197106|Secondary|Mean Change From Baseline in Percentage Predicted Forced Expiratory Volume in One Second (FEV1) at Week 26|Change from Baseline was calculated as the Week 26 value minus the Baseline value. The percentage predicted FEV1 is defined as the volume of air that can be forced out in one second after taking a deep breath and is corrected for the FEV1 value corresponding with the same age.|Baseline and Week 26|Per protocol (PP) population: participants of the Intent-to-Treat (ITT) Population (participants who had taken at least one dose of study medication) who completed the study without any major protocol violations. At baseline there were 6 missing data and 4 improper testings that could not be used in the analysis.||percent predicted change||Standard Deviation|Mean
712703|NCT00197106|Secondary|Percentage of Symptom-free Days During the Entire Treatment Period|Asthma symptom-free days are defined as days (24 hour period) with no symptoms, as recorded in the participant’s diary|Baseline to Week 26|Per protocol (PP) population: participants of the Intent-to-Treat (ITT) Population (participants who had taken at least one dose of study medication) who completed the study without any major protocol violations||percentage of days||Standard Deviation|Mean
712704|NCT00197106|Primary|Percentage of Symptom-free Days During the Last 10 Weeks of the Treatment Period|Asthma symptom-free days are defined as days (24 hour period) with no symptoms, as recorded in the participant’s diary.|Last 10 weeks of the treatment period (Weeks 16-26)|Per protocol (PP) population: participants of the Intent-to-Treat (ITT) Population (participants who had taken at least one dose of study medication) who completed the study without any major protocol violations||percentage of days||Standard Deviation|Mean
712705|NCT00197119|Primary|Serious Adverse Events (SAE) Causally Related to Primary Vaccination or Related to Hepatitis A or B Infection or Related to Study Participation (Blood Sampling)|"An SAE is any untoward medical occurrence that:
results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/ incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above."|From Year 6 through to Year 10|||subjects|||Number
712706|NCT00197119|Primary|Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-Off Value|Anti-HBs antibody concentration cut-off value assessed was ≥ 3.3 mIU/mL.|Year 6, 7, 8, 9 and 10 after the first vaccine dose of a two-dose or three-dose primary vaccination|Analysis was performed on the ATP cohort for immunogenicity, which included all subjects for whom serology results were available for a particular blood sampling visit.||subjects|||Number
712708|NCT00197184|Secondary|Number of Subjects Receiving an Additional Vaccine Dose and Reporting Any Serious Adverse Events|"A serious adverse event (SAE) is any untoward medical occurrence that:
results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above."|At least one month after additional vaccination|Analysis was performed on the Total vaccinated cohort for the challenge dose, including all subjects who received an additional vaccine dose between 6 to 12 months after year 5.||subjects|||Number
712709|NCT00197184|Secondary|Number of Subjects Receiving an Additional Vaccine Dose and Reporting Unsolicited Adverse Events (AEs).|An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|During the 30-day follow-up period after additional vaccination.|Analysis was performed on the Total vaccinated cohort for the challenge dose, including all subjects who received an additional vaccine dose between 6 to 12 months after year 5.||subjects|||Number
712710|NCT00197184|Secondary|Number of Subjects Receiving an Additional Vaccine Dose and Reporting Solicited General Symptoms.|"Solicited general symptoms assessed include fatigue, fever, gastrointestinal symptoms and headache.
Any= regardless of intensity grade or relationship to vaccination; grade 3= prevented normal activity; Related= considered by the investigator to be causally related to the vaccination"|During the 4-day follow-up period after additional vaccination|Analysis was performed on the Total vaccinated cohort for the challenge dose, including all subjects who received an additional vaccine dose between 6 to 12 months after year 5.||subjects|||Number
712711|NCT00197184|Secondary|Number of Subjects Receiving an Additional Vaccine Dose and Reporting Solicited Local Symptoms|"Solicited local symptoms assessed include pain, redness and swelling at the vaccine injection site.
Any= regardless of intensity grade; Grade 3 Pain= spontaneously painful"|during the 4-day follow-up period after additional vaccination|Analysis was performed on the Total vaccinated cohort for the challenge dose, including all subjects who received an additional vaccine dose between 6 to 12 months after year 5.||subjects|||Number
712712|NCT00197184|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs) Determined by the Investigator to Have a Causal Relationship to Primary Vaccination or Due to Lack of Vaccine Efficacy.|"A serious adverse event (SAE) is any untoward medical occurrence that:
results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above."|From last study visit of the primary study up to Year 5 long term follow-up|The analysis was performed on the Long term Total vaccinated cohort wich included all subjects who returned at a specified follow-up study||subjects|||Number
712713|NCT00197184|Primary|Anti-HBs Antibody Concentrations in Subjects Receiving the Additional Vaccine Dose.|Subjects losing seroprotective anti-HBs antibody titres (i.e. titres < 10 mIU/ml) at any long term time point, received an Engerix™ challenge dose. The table presents the geometric mean concentrations for anti-HBs antibodies, expressed as Milli-International Units per milliliter (mIU/mL).|Before and One month after additional vaccination|Analysis was performed on the Total vaccinated cohort for the challenge dose, including all subjects who received an additional vaccine dose between 6 to 12 months after year 5.||mIU/mL||95% Confidence Interval|Geometric Mean
712714|NCT00197184|Primary|Anti-HAV Antibody Concentrations in Subjects Receiving the Additional Vaccine Dose.|Any subjects becoming seronegative for anti-HAV antibodies (i.e. titres < 15 mIU/ml) at any long term time point, were to receive an additional vaccine dose administered between 6 to 12 months after Year 5 time point.|Before and one month after additional vaccination|None of the subjects became seronegative for anti-HAV antibodies during the Year 2 to Year 5 long term follow-up. Hence none of the subjects received an additional Havrix dose.|||||
712715|NCT00197184|Primary|Anti-hepatitis B (HBs) Antibody Concentrations|Geometric mean concentration for anti-HBs antibodies expressed as Milli-International Units per milliliter (mIU/mL).|Year 2 (Month 24), Year 3 (Month 36), Year 4 (Month 48) and Year 5 (Month 60)|Analysis was performed on the Long Term According to Protocol cohort for analysis of immunogenicity (LT ATP immunogenicity cohort) which included all subjects that complied with the protocol and for whom data concerning immunogenicity endpoint measures were available for the particular time point measured.||mIU/mL||95% Confidence Interval|Geometric Mean
712716|NCT00197184|Primary|Anti-hepatitis A (HAV) Antibody Concentrations|Geometric mean concentration for anti-HAV antibodies expressed as Milli-International Units per milliliter (mIU/mL)|Year 2 (Month 24), Year 3 (Month 36), Year 4 (Month 48) and Year 5 (Month 60)|Analysis was performed on the Long Term According to Protocol cohort for analysis of immunogenicity (LT ATP immunogenicity cohort) which included all subjects that complied with the protocol and for whom data concerning immunogenicity endpoint measures were available for the particular time point measured.||mIU/mL||95% Confidence Interval|Geometric Mean
712717|NCT00197236|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs), New Chronic Illnesses and Medically Significant Events|Since the related information about medically significant events was not specifically collected and new chronic illnesses were only collected in the extended safety follow-up phase, all unsolicited adverse events (AEs) throughout the study are reported in the table without identifying which event was a medically significant or new chronic illness.|Active Phase and the 6-months Extended Safety Follow-up (ESFU) Phase.|The analyses were performed on the Total Vaccinated Cohort for the active phase of the study and on the Extended safety follow-up cohort for the 6-month extended follow-up (ESFU) phase.||subjects|||Number
712718|NCT00197236|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|31-day period following each dose of study vaccine(s)|The analysis was performed on the Total Vaccinated Cohort||subjects|||Number
712719|NCT00197236|Secondary|Number of Subjects Reporting Solicited General Adverse Events (AEs)|Solicited general AEs assessed include drowsiness, axillary fever ≥ 37.5°C, irritability and loss of appetite. Data across doses are presented in the table.|4-day period following each dose of study vaccine(s)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.||subjects|||Number
712720|NCT00197236|Primary|Number of Vaccine Responders for Anti-pertussis Toxoid (PT), Anti-filamentous Hemagglutinin (FHA) and Anti-pertactin (PRN)|Subjects are considered as being vaccine responders if they were initially seronegative and become seropositive (≥ 5 Enzyme Linked Immunosorbent Assay Units per Milliliter (EL.U/mL)), or were initially seropositive and have a 2-fold increase above pre-study concentrations.|31 days following the administration of Infanrix™ and ActHIB|Analysis was performed on the According-to-Protocol cohort for immunogenicity, only for those groups receiving Infanrix and ActHIB vaccines.||subjects|||Number
712721|NCT00197236|Secondary|Number of Subjects Reporting Solicited Local Adverse Events (AEs)|Solicited local AEs assessed include pain, redness and swelling. Data across doses are presented in the table.|4-day period following each dose of study vaccine(s)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.||subjects|||Number
712722|NCT00197236|Secondary|Number of Subjects With Vaccine Response to Havrix™.|Vaccine response to Havrix is defined as post-vaccination anti-HAV antibody concentrations ≥ 15 mIU/mL in initially seronegative subjects or a ≥ 2-fold increase above the pre-vaccination anti-HAV antibody concentration in initially seropositive subjects.|31 days following the second dose|Analysis was performed on the According-to-Protocol cohort for immunogenicity||subjects|||Number
712723|NCT00197236|Secondary|Anti-hepatitis Virus A (HAV) Antibody Geometric Mean Concentrations (GMC) Following the Second Dose of Havrix|Anti-hepatitis A (HAV) antibody geometric mean concentrations (GMC) are expressed as milli-International Units per milliliter (mIU/mL).|31 days following the second dose of Havrix™|Analysis was performed on the According-to-Protocol cohort for immunogenicity.||mIU/mL||95% Confidence Interval|Geometric Mean
712724|NCT00197236|Secondary|Anti-hepatitis A Virus (HAV) Antibody Geometric Mean Concentrations (GMC) Following the First Dose of Havrix|Anti-hepatitis A (HAV) antibody geometric mean concentrations (GMC) are expressed as milli-International Units per milliliter (mIU/mL).|31 days following the first dose of Havrix™|Analysis was performed on the According-to-Protocol cohort for immunogenicity, only for the Havrix Group and the Havrix + Infanrix + ActHIB Group.||mIU/mL||95% Confidence Interval|Geometric Mean
712725|NCT00197236|Secondary|Number of Seropositive Subjects for Anti-hepatitis A Virus (HAV) Antibodies Following the First Dose of Havrix|Subjects are defined as being anti-HAV seropositive if their anti-HAV antibody concentration is ≥ 15 milli-International Units per milliliter (mIU/mL).|31 days following the first dose of Havrix™|Analysis was performed on the According-to-Protocol cohort for immunogenicity, only for the Havrix Group and the Havrix + Infanrix + ActHIB Group.||subjects|||Number
712726|NCT00197236|Secondary|Number of Subjects Seropositive for Anti-pertussis Toxoid (PT), Anti-filamentous Hemagglutinin (FHA), Anti-pertactin (PRN) and Anti-polyribosylribitol Phosphate (PRP)|Seropositivity is defined as antibody concentrations ≥ 5 Enzyme Linked Immunosorbent Assay Units per Milliliter (EL.U/mL) for anti-PT, anti-FHA and anti-PRN antibodies and as antibody concentrations ≥ 0.15 microgram/milliliter (µg/mL) for anti-PRP antibodies.|31 days following the administration of Infanrix™ and ActHIB|Analysis was performed on the According-to-Protocol cohort for immunogenicity, only for those groups receiving Infanrix and ActHIB vaccines.||subjects|||Number
712727|NCT00197236|Secondary|Anti-polyribosylribitol Phosphate (PRP) Antibody Geometric Mean Concentrations (GMC)|GMCs are expressed as microgram/milliliter (µg/mL).|31 days following the administration of Infanrix™ and ActHIB|Analysis was performed on the According-to-Protocol cohort for immunogenicity, only for those groups receiving Infanrix and ActHIB vaccines.||µg/mL||95% Confidence Interval|Geometric Mean
712728|NCT00197236|Secondary|Anti-diphtheria and Anti-tetanus Antibody Geometric Mean Concentrations (GMC)|GMCs are expressed as International Units per milliliter (IU/mL).|31 days following the administration of Infanrix™ and ActHIB|Analysis was performed on the According-to-Protocol cohort for immunogenicity, only for those groups receiving Infanrix and ActHIB vaccines.||IU/mL||95% Confidence Interval|Geometric Mean
712729|NCT00197236|Primary|Number of Anti-diphtheria, Anti-tetanus and Anti-polyribosylribitol Phosphate (PRP) Seroprotected Subjects|Subjects are defined as being anti-diphtheria, anti-tetanus and anti-PRP seroprotected if their anti-diphtheria and anti-tetanus antibody concentration is ≥ 0.1 International Units per milliliter (IU/mL) and if their anti-PRP antibody concentration is ≥ 1 microgram per milliliter (μg/mL), respectively.|31 days following the administration of Infanrix™ and ActHIB|Analysis was performed on the According-to-Protocol cohort for immunogenicity, only for those groups receiving Infanrix and ActHIB vaccines.||subjects|||Number
712730|NCT00197236|Primary|Number of Seropositive Subjects for Anti-hepatitis A Virus (HAV) Antibodies Following the Second Dose of Havrix|Subjects are defined as being anti-HAV seropositive if their anti-HAV antibody concentration is ≥ 15 milli-International Units per milliliter (mIU/mL).|31 days following the second dose of Havrix™|Analysis was performed on the According-to-Protocol cohort for immunogenicity including subjects who had at least one study vaccine administered and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||subjects|||Number
712731|NCT00197392|Secondary|Number of Catheter Insertion Attempts|Number of insertions needed to place catheter|Implantation of subject|||insertions|||Number
712732|NCT00197392|Secondary|Length of Catheter Tunneling Into the Brain|Length of tunneling of EVD catheter in the brain for each analysis population.|Implant of subject|||cm||Standard Deviation|Mean
712733|NCT00197392|Secondary|Hospital Locations for EVD Catheter Placement|Number of subjects in each analysis population where the EVD catheter placement occurred; either in the Intensive Care Unit (ICU)or the Operating Room (OR).|Implantation of subject|||Participants|||Number
712734|NCT00197392|Secondary|Time Point of Introduction of Systemic Antibiotic Therapy|Time points of then patients received systemic antibiotic therapy|Within 48 hours of implant of subjects to explant|||Paticipants|||Number
712735|NCT00197392|Secondary|Non-infectious Catheter Failure in the MITT Population|Reasons for non-infectious catheter malfunctions in the Modified intent to treat population.|Implant of subject to explant|||Participants|||Number
712736|NCT00197392|Secondary|Diagnosis Requiring EVD Implantation|Primary diagnosis for implantation of EVD system|Implantation of EVD system|Analysis consisted of combining both Arm/Group (Bactiseal and Standard)||Participants|||Number
712737|NCT00197392|Secondary|Average Subject Age|The average subject age|Implant to subject|||Years||Standard Deviation|Mean
712738|NCT00197392|Secondary|Number of Days With Indwelling Catheter|Days catheter was implanted in subjects|Implant of subjects to day of explant|||Days||Standard Deviation|Mean
712750|NCT00198029|Primary|The Disabilities of the Arm, Shoulder and Hand Outcome Measure|The DASH Outcome Measure is a 30-item, self-report questionnaire designed to measure physical function and symptoms in people with any of several musculoskeletal disorders of the upper limb. Scores are transformed to a 0-100 scale, with a higher value indicating greater disability. The change in DASH (delta) over those 6 months was recorded.|26 weeks (6 months)|||units on a scale||Standard Deviation|Mean
712751|NCT00198042|Other Pre-specified|Bone Tunnel Cross Sectional Area||2 years||||||
712752|NCT00198042|Primary|Bone Tunnel Diameter|Bone tunnel diameter measured on MRI|2 years|MRI measurement of tunnel dimensions.||mm||Standard Deviation|Mean
712753|NCT00198081|Primary|Concentration of PGEM in Serum at Baseline, Surgery, 1 wk, 4wks, and 6 Months|Measured by Elisa at participant level - only participant level data available; not summarized across group|Baseline, surgery, 1 wk, 4 wks, and 6 months|||pg/ml|||Number
712754|NCT00198081|Primary|Concentration of PGEM in Urine at Baseline, Surgery, 1 wk, 4wks, and 6 Months|Measured by Elisa at participant level - only participant level data available; not summarized across group|Baseline, surgery, 1 wk, 4 wks, and 6 months|||pg/ml|||Number
712755|NCT00198081|Primary|Concentration of PGE2 in Serum at Baseline, Surgery, 1 wk, 4wks, and 6 Months|Measured by Elisa at participant level - only participant level data available; not summarized across group|Baseline, surgery, 1 wk, 4 wks, and 6 months|||pg/ml|||Number
712756|NCT00198081|Secondary|Number of Participants With Clinical Changes in IPMN Progression.|Examine the short term effect of celecoxib on clinical progression of IPMN in the surgical arm; Examine the long term effect of celecoxib on clinical progression of IPMN in the medical arm.|Baseline, 6 months, 1 year|Data never collected for surgical arm; medical arm of study never initiated.|||||
712757|NCT00198081|Primary|Concentration of PGE2 in Urine at Baseline, Surgery, 1 wk, 4wks, and 6 Months|Measured by Elisa at participant level - only participant level data available; not summarized across group|Baseline, surgery, 1 wk, 4 wks, and 6 months|||pg/ml|||Number
712758|NCT00198133|Secondary|Grade 3/4 Treatment Related Adverse Events|To determine the toxicity of premetrexed in this patient population, the number of patients who experienced grade 3 or 4 adverse events will be reported that were treatment related (possibly, probably, definitely).|Up to 3 years|All patients enrolled and received treatment||participants|||Number
712759|NCT00198133|Secondary|Duration of Remission|Will be examined using Kaplan-Meier estimates. Time from earliest confirmed remission criteria until death or progression will be calculated. If a patient continued to be in remission at the end of the study, they will be censored at their last evaluation in the analysis.|Time from the date of remission until progression or death, assessed up to 3 years|All patients with at least one post baseline measurement who had a response of CR or PR||months||95% Confidence Interval|Median
712760|NCT00198133|Primary|Objective Response Rate (Complete and Partial Response)|The percent of patients having an objective response (complete or partial response) will be estimated with a 95% exact binomial confidence interval for the percent of patients receiving drug. RECIST v1.0 will be used. At least a 30% decrease in the sum of the longest diameter of target lesions in reference to the baseline longest diameter will need to take place to be considered an objective response.|Up to 3 years|All patients with at least one post baseline measurement. (26 evaluable – 15 T and 11 TC patients)||percentage of participants||95% Confidence Interval|Number
712761|NCT00198822|Secondary|Plasma Retinol at the Third Trimester of Pregnancy (Nutritional Status of the Mother)||Third trimester of pregnancy (about the 32nd week of gestation)|||micromoles per liter||Standard Deviation|Mean
712762|NCT00198822|Primary|All-cause, Pregnancy-related Mortality|Mortality evaluated on intent-to-treat basis|Deaths during pregnancy through 12 weeks postpartum|As the study ended on the advice of the Data and Safety Monitoring Board, based on evidence of no difference, all enrolled women who had a chance of being followed through 84 days after the end of their pregnancy were included in the trial. The cohort included pregnancies identified between August 17, 2001 and January 5, 2006.||Participants|||Number
712763|NCT00198822|Secondary|Plasma Beta-carotene in the Third Trimester of Pregnancy(Nutritonal Status of the Mother)||Third trimester of pregnancy (about the 32nd week of gesatation)|||Plasma beta-carotene micromoles / liter||Standard Deviation|Mean
712764|NCT00198822|Secondary|Infant Morbidity Through 3 Months of Age||within 24 weeks after birth||||||
712765|NCT00198822|Secondary|Fetal Growth and Postnatal Infant Growth Through Three Months of Age||through the 1st 12 weeks after birth||||||
712766|NCT00198822|Secondary|Gestational Age at Birth||within 24 weeks after birth||||||
712767|NCT00198822|Secondary|Maternal Morbidity, Including Obstetric Complications||through the 1st 24 weeks following termination of pregnancy||||||
712768|NCT00198822|Secondary|All-cause 3-month Infant Mortality||Deaths through the 1st 12 weeks of life|Mortality evaluated on intent-to-treat basis||participants|||Number
712779|NCT00205712|Secondary|Visual Analog Scale (VAS) Anxiety Rating|Anxiety was measured on a scale of 1-10 (1=lowest pain intensity, 10=highest pain intensity) in participants before medication, during medication, post medication and 1 week follow up.|Before Ketamine, During Ketamine, Post Ketamine, 1 week follow up|||Scale of 1-10||Standard Deviation|Mean
712780|NCT00205712|Secondary|Visual Analog Scale (VAS) Pain Intensity|Pain intensity was measured on a scale of 1-10 (1=lowest pain intensity, 10=highest pain intensity) in participants before medication, during medication, post medication and 1 week follow up.|Before Ketamine, During Ketamine, Post Ketamine and 1 Week Follow up|Completers analysis per protocol. Two participants were missing some data at either the before ketamine or during ketamine time point.||Scale of 1-10||Standard Deviation|Mean
712781|NCT00205712|Primary|Brief Psychiatric Ratings Scale (BPRS) Positive Symptom Subscale Score|Participant received behavioral ratings before medication and during medication for the primary analysis comparison. This is an observer-scale with a value range from 0-6 (0=no symptoms 6=worst symptoms)|Before Ketamine, During Ketamine|Completers analysis per protocol. Two participants were missing some data at either the before ketamine or during ketamine time point.||Scale of 0-6||Standard Deviation|Mean
712782|NCT00205777|Secondary|Change From Baseline in Euro Quality of Life-5 Dimensions (EQ-5D)- Health State Profile Utility Score at Month 12, 24 and 36|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. Baseline values at different time points were considered only for the participants who were evaluable at those time points."|Baseline, Months 12, 24, 36|ITT population included all randomized participants who took at least 1 dose of test article;had baseline data and at least one valid assessment while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. ‘n’=participants who were evaluable for this measure at the specified time point for each arm group.||Units on a scale||Standard Deviation|Mean
712783|NCT00205777|Secondary|Euro Quality of Life-5 Dimensions (EQ-5D)- Health State Profile Utility Score|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. Baseline values at different time points were considered only for the participants who were evaluable at those time points."|Baseline|ITT population included all randomized participants who took at least 1 dose of test article;had baseline data and at least one valid assessment while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. ‘n’=participants who were evaluable for this measure at the specified time point for each arm group.||Units on a scale||Standard Deviation|Mean
712784|NCT00205777|Secondary|Change From Baseline in Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Month 12, 24 and 36|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. Baseline values at different time points were considered only for the participants who were evaluable at those time points.|Baseline, Months 12, 24, 36|ITT population included all randomized participants who took at least 1 dose of test article;had baseline data and at least one valid assessment while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. ‘n’=participants who were evaluable for this measure at the specified time point for each arm group.||mm||Standard Error|Least Squares Mean
712785|NCT00205777|Secondary|Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. Baseline values at different time points were considered only for the participants who were evaluable at those time points.|Baseline|ITT population included all randomized participants who took at least 1 dose of test article;had baseline data and at least one valid assessment while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. ‘n’=participants who were evaluable for this measure at the specified time point for each arm group.||millimeter (mm)||Standard Deviation|Mean
712786|NCT00205777|Secondary|Change From Baseline in European Foundation for Osteoporosis Quality of Life Questionnaire (QUALEFFO) at Month 12, 24 and 36|QUALEFFO is an osteoporosis-specific health instrument developed specifically for participants with vertebral deformities used to evaluate the effect of back pain and treatment on quality of life. The QUALEFFO questionnaire includes 41 items in 5 domains: pain, physical function, social function, general health perception, and mental function. The total score is calculated according to the scoring algorithm developed by the International Osteoporosis Foundation. Total scores are reported from 0 to 100, with lower scores corresponding to better quality of life. Baseline values at different time points were considered only for the participants who were evaluable at those time points.|Baseline, Months 12, 24, 36|ITT population included all randomized participants who took at least 1 dose of test article;had baseline data and at least one valid assessment while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. ‘n’=participants who were evaluable for this measure at the specified time point for each arm group.||Units on a scale||Standard Error|Least Squares Mean
712787|NCT00205777|Secondary|European Foundation for Osteoporosis Quality of Life Questionnaire (QUALEFFO)|QUALEFFO is an osteoporosis-specific health instrument developed specifically for participants with vertebral deformities used to evaluate the effect of back pain and treatment on quality of life. The QUALEFFO questionnaire includes 41 items in 5 domains: pain, physical function, social function, general health perception, and mental function. The total score is calculated according to the scoring algorithm developed by the International Osteoporosis Foundation. Total scores are reported from 0 to 100, with lower scores corresponding to better quality of life. Baseline values at different time points were considered only for the participants who were evaluable at those time points.|Baseline|ITT population included all randomized participants who took at least 1 dose of test article;had baseline data and at least one valid assessment while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. ‘n’=participants who were evaluable for this measure at the specified time point for each arm group.||Units on a scale||Standard Deviation|Mean
712788|NCT00205777|Secondary|Change From Baseline in Women’s Health Questionnaire (WHQ) at Month 12, 24 and 36|WHQ is a measure of mid-aged women's emotional and physical health. Consists of 36-item assessing nine domains of physical and emotional health: Depressed mood; Somatic symptoms; Anxiety/fears; Vasomotor symptoms; Sleep problems; Sexual behavior; Menstrual symptoms; Memory/concentration; and Attractiveness. Each item scored on a 4 point scale (yes definitely, yes sometimes, not much, no not at all) reduced to binary option as 0 (no) and 1 (yes). Domain subscale score was calculated as sum of domain items score divided by number of domain items. Total score was calculated as the sum of individual domain subscale score divided by number of domains. Total score range from 0 (absent) to 1 (present), with higher scores indicating more pronounced distress and dysfunction.Baseline values at different time points were considered only for the participants who were evaluable at those time points.|Baseline, Months 12, 24, 36|ITT population included all randomized participants who took at least 1 dose of test article;had baseline data and at least one valid assessment while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. ‘n’=participants who were evaluable for this measure at the specified time point for each arm group.||Units on a scale||Standard Error|Least Squares Mean
712789|NCT00205777|Secondary|Women’s Health Questionnaire (WHQ)|WHQ is a measure of mid-aged women's emotional and physical health. Consists of 36-item assessing nine domains of physical and emotional health: Depressed mood; Somatic symptoms; Anxiety/fears; Vasomotor symptoms; Sleep problems; Sexual behavior; Menstrual symptoms; Memory/concentration; and Attractiveness. Each item scored on a 4 point scale (yes definitely, yes sometimes, not much, no not at all) reduced to binary option as 0 (no) and 1 (yes). Domain subscale score was calculated as sum of domain items score divided by number of domain items. Total score was calculated as the sum of individual domain subscale score divided by number of domains. Total score range from 0 (absent) to 1 (present), with higher scores indicating more pronounced distress and dysfunction. Baseline values at different time points were considered only for the participants who were evaluable at those time points.|Baseline|ITT population included all randomized participants who took at least 1 dose of test article;had baseline data and at least one valid assessment while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. ‘n’=participants who were evaluable for this measure at the specified time point for each arm group.||Units on a scale||Standard Deviation|Mean
712790|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 60: BFRBV|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Bone Formation Rate (BFR)-Bone Volume Reference (BFRBV). BFR accounts the bone volume which is actively mineralizing, which depends on the number of osteoblasts that are active. BFR= Fraction of mineralizing volume and bone volume multiplied by mineralization apposition rate (MAR).|Month 60|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.||square millimetre/square millimetre/year||Standard Error|Least Squares Mean
712791|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 36: BFRBV|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Bone Formation Rate (BFR)-Bone Volume Reference (BFRBV). BFR accounts the bone volume which is actively mineralizing, which depends on the number of osteoblasts that are active. BFR= Fraction of mineralizing volume and bone volume multiplied by mineralization apposition rate (MAR).|Month 36|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.||square millimetre/square millimetre/year||Standard Error|Least Squares Mean
712792|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 60: TbN|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Trabecular Number (TbN). TbN= Ratio of bone volume to tissue volume divided by trabecular thickness.|Month 60|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.||ratio/mm||Standard Error|Least Squares Mean
712793|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 36: TbN|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Trabecular Number (TbN). TbN= Ratio of bone volume to tissue volume divided by trabecular thickness.|Month 36|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.||ratio/millimeter (ratio/mm)||Standard Error|Least Squares Mean
712794|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 60: MAR|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Mineral Apposition Rate (MAR). MAR is the area of new bone formed during the label interval.|Month 60|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.||mcm/d||Standard Error|Least Squares Mean
712795|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 36: MAR|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Mineral Apposition Rate (MAR). MAR is the area of new bone formed during the label interval.|Month 36|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.||mcm/days (mcm/d)||Standard Error|Least Squares Mean
712796|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 60: Mlt|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Mineralization Lag Time (Mlt). Mineralization lag time was the lag between the time osteoid was formed and the mineral was added.|Month 60|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.||days||Standard Error|Least Squares Mean
712797|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 36: Mlt|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Mineralization Lag Time (Mlt). Mineralization lag time was the lag between the time osteoid was formed and the mineral was added.|Month 36|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.||days||Standard Error|Least Squares Mean
712798|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 60: ACF|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Activation Frequency (ACF). The total period (TP) is the duration between the beginning of one formation period (FP) and the beginning of the next FP. The number of times per year that this spot begins the FP is the activation frequency (ACF).|Month 60|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.||Activation of bone formation/year||Standard Error|Least Squares Mean
712799|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 36: ACF|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Activation Frequency (ACF). The total period (TP) is the duration between the beginning of one formation period (FP) and the beginning of the next FP. The number of times per year that this spot begins the FP is the activation frequency (ACF).|Month 36|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.||Activation of bone formation/year||Standard Error|Least Squares Mean
712800|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 60: BFRTS|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Bone Form Rate (BFR)-Total Surface Reference (BFRTS). BFR accounts the bone surface which is actively mineralizing, which depends on the number of osteoblasts that are active. BFR= Fraction of mineralizing surface and bone surface multiplied by mineralization apposition rate (MAR).|Month 60|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.||cubic millimetre/square millimetre/year||Standard Error|Least Squares Mean
712801|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 36: BFRTS|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Bone Form Rate (BFR)-Total Surface Reference (BFRTS). BFR accounts the bone surface which is actively mineralizing, which depends on the number of osteoblasts that are active. BFR= Fraction of mineralizing surface and bone surface multiplied by mineralization apposition rate (MAR).|Month 36|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.||cubic millimetre/square millimetre/year||Standard Error|Least Squares Mean
713260|NCT00211510|Secondary|Changes in Hyperglycemia Area Under the Curve (AUC) From Baseline to Week 26|Hyperglycemia is defined as a recorded blood glucose event > 180 mg/dL. The amount of time spent above this parameter will be analyzed and compared between groups from Baseline to Week 26|Baseline and 26 weeks|||mmol/dl*min||Standard Deviation|Mean
712802|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 60: SuD|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Surface Density (SuD).|Month 60|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.||square millimeter per cubic millimeter||Standard Error|Least Squares Mean
712803|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 36: SuD|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Surface Density (SuD).|Month 36|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.||square millimeter per cubic millimeter||Standard Error|Least Squares Mean
712804|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 60: BFP, RP and RmP|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: Bone Formation Period (BFP), Resorption Period (RP), Remodeling Period (RmP).|Month 60|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants evaluable for this measure at the specified time point for each arm group.||yrs||Standard Error|Least Squares Mean
712805|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 36: BFP, RP and RmP|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: Bone Formation Period (BFP), Resorption Period (RP), Remodeling Period (RmP).|Month 36|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants evaluable for this measure at the specified time point for each arm group.||years (yrs)||Standard Error|Least Squares Mean
712806|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 60: TtAr|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated variable: Tissue Area (TtAr). Tissue area comprised of the porous calcified substance from which bones were made.|Month 60|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.||mm^2||Standard Error|Least Squares Mean
712807|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 36: TtAr|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated variable: Tissue Area (TtAr). Tissue area comprised of the porous calcified substance from which bones were made.|Month 36|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.||Square millimeter (mm^2)||Standard Error|Least Squares Mean
712808|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 60: TSG|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: Total Surface (Goldner Slide) [TSG]. All specimens were demineralized and subjected to staining procedures (Goldner`s staining). Slides were analyzed using light microscopy for total surface area, the surface area that consisted of bone and the surface area that consisted of graft material (all in mm^2 and expressed as percent (%) of the total surface.|Month 60|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.||mm||Standard Error|Least Squares Mean
712809|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 36: Total Surface (Goldner Slide) [TSG]|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: Total Surface (Goldner Slide) [TSG]. All specimens were demineralized and subjected to staining procedures (Goldner`s staining). Slides were analyzed using light microscopy for total surface area, the surface area that consisted of bone and the surface area that consisted of graft material (all in mm^2 and expressed as percent (%) of the total surface.|Month 36|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.||millimeter (mm)||Standard Error|Least Squares Mean
712883|NCT00206518|Secondary|Disease Relapse|Data associated with relapse and progression will be obtained over the course of 10 years. Relapse/progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|10 years|||participants|||Number
712810|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 60: WTh, OTh, TbTh, TbSp and CTh|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: WTh, OTh, TbTh, TbSp and CTh. Trabecular separation defined as the thickness of the spaces as defined by binarization within the volume of interest.|Month 60|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants evaluable for this measure at the specified time point for each arm group.||mcm||Standard Error|Least Squares Mean
712811|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 36: WTh, OTh, TbTh, TbSp and CTh|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: Wall Thickness (WTh), Osteoid Thickness (OTh), Trabecular Thickness (TbTh), Trabecular Separation (TbSp) and Cortical thickness (CTh). Trabecular separation defined as the thickness of the spaces as defined by binarization within the volume of interest.|Month 36|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants evaluable for this measure at the specified time point for each arm group.||micrometer (mcm)||Standard Error|Least Squares Mean
712812|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 60: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Percentage of following indices (volume,surface,porosity) was calculated:Bone Volume(BV), Osteoid Volume(OV), Osteoid Surface(OS), Osteoclast Surface(OcS), Osteoblast Surface(ObS), Mineralizing surface(MS), Eroded Surface(ES), Osteoid Mineralizing surface(OMS), Cortical porosity(CP).|Month 60|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants evaluable for this measure at the specified time point for each arm group.||Percentage of indices||Standard Error|Least Squares Mean
712813|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 36: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Percentage of following indices (volume,surface,porosity) was calculated:Bone Volume(BV), Osteoid Volume(OV), Osteoid Surface(OS), Osteoclast Surface(OcS), Osteoblast Surface(ObS), Mineralizing surface(MS), Eroded Surface(ES), Osteoid Mineralizing surface(OMS), Cortical porosity(CP).|Month 36|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants evaluable for this measure at the specified time point for each arm group.||Percentage of indices||Standard Error|Least Squares Mean
712814|NCT00205777|Secondary|Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36|Lipid parameters evaluated included total cholesterol (TC), low density lipoprotein (LDL), high density lipoprotein (HDL), triglyceride (TG), high-density lipoprotein fraction 2 (HDL2) and high-density lipoprotein fraction 3 (HDL3).|Baseline, Months 6, 12, 24, 36|ITT population included all randomized participants who took at least 1 dose of test article. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' is signifying those participants who were evaluable for this measure at the specified time point for each arm group.||Percent change||Inter-Quartile Range|Median
712815|NCT00205777|Secondary|Percent Change From Baseline in C-telopeptide (CTx) at Months 72 and 84|C-telopeptide is a biochemical marker of bone formation. Blood samples were collected to evaluate C-telopeptide levels.|Baseline, Months 72, 84|mITT of SP1 population included all randomized participants who took at least 1 dose of test article. 'N' (number of participants analyzed) signifies those participants evaluable for this measure.||Percent change||Inter-Quartile Range|Median
712816|NCT00205777|Secondary|Percent Change From Baseline in C-telopeptide (CTx) at Months 36 and 60|C-telopeptide is a biochemical marker of bone formation. Blood samples were collected to evaluate C-telopeptide levels.|Baseline, Months 36, 60|mITT of SP1 population included all randomized participants who took at least 1 dose of test article. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ is signifying those participants who were evaluable for this measure at the specified time point for each arm group.||Percent change||Inter-Quartile Range|Median
712817|NCT00205777|Secondary|Percent Change From Baseline in C-telopeptide (CTx) at Month 3, 6 and 12|C-telopeptide is a biochemical marker of bone formation. Blood samples were collected to evaluate C-telopeptide levels.|Baseline, Months 3, 6, 12|ITT population included all randomized participants who took at least 1 dose of test article. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' is signifying those participants who were evaluable for this measure at the specified time point for each arm group.||Percent change||Inter-Quartile Range|Median
712818|NCT00205777|Secondary|Percent Change From Baseline in Osteocalcin at Months 72 and 84|Osteocalcin is a biochemical marker of bone formation. Blood samples were collected to evaluate osteocalcin levels.|Baseline, Months 72, 84|mITT of SP1 population included all randomized participants who took at least 1 dose of test article. 'N' (number of participants analyzed) signifies those participants evaluable for this measure.||Percent change||Inter-Quartile Range|Median
712918|NCT00207142|Secondary|Change From Baseline in HIV-1 RNA at Week 24 of the Induction Phase|Change From Baseline in HIV-1 RNA at Week 24 of the Induction Phase. Change=Week 24 Induction Phase value - Baseline value; a decrease signifies improvement.|Baseline, Week 24 of Induction Phase|Analyses use observed values (participants included are those with HIV-1 RNA measurements at baseline and at Week 24 of Induction Phase).||log10 c/mL||Standard Error|Mean
712819|NCT00205777|Secondary|Percent Change From Baseline in Osteocalcin at Months 36 and 60|Osteocalcin is a biochemical marker of bone formation. Blood samples were collected to evaluate osteocalcin levels.|Baseline, Months 36, 60|mITT of SP1 population included all randomized participants who took at least 1 dose of test article.'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ is signifying those participants who were evaluable for this measure at the specified time point for each arm group.||Percent change||Inter-Quartile Range|Median
712820|NCT00205777|Secondary|Percent Change From Baseline in Osteocalcin at Month 3, 6 and 12|Osteocalcin is a biochemical marker of bone formation. Blood samples were collected to evaluate osteocalcin levels.|Baseline, Months 3, 6, 12|ITT population included all randomized participants who took at least 1 dose of test article. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ is signifying those participants who were evaluable for this measure at the specified time point for each arm group.||Percent change||Inter-Quartile Range|Median
712821|NCT00205777|Secondary|Percent Change From Baseline in Bone Mineral Density (BMD) at Months 72 and 84|BMD of lumbar spine (Lu Sp) and hip (total hip [Tl Hp], femoral neck [Fe Ne] and femur trochanter [Fe Tr]) was evaluated by dual-energy x-ray absorptiometry (DXA). The left hip was evaluated unless prevented by pathology, in which case the right hip was evaluated throughout the study. Results were scored as T score, defined as BMD at the site when compared to the young normal reference mean. Normal BMD is a T-score of -1.0 or higher.|Baseline, Month 72, 84|Modified ITT(mITT) population of SP1 population:randomized participants who took at least 1 dose of test article;had baseline BMD and at least one valid BMD while on therapy. N (number of participants analyzed)=participants evaluable.n=participants with specified baseline fracture status.||Percent change||Standard Deviation|Mean
712822|NCT00205777|Secondary|Percent Change From Baseline in Bone Mineral Density (BMD) at Months 48, 60|BMD of lumbar spine (Lu Sp) and hip (total hip [Tl Hp], femoral neck [Fe Ne] and femur trochanter [Fe Tr]) was evaluated by dual-energy x-ray absorptiometry (DXA). The left hip was evaluated unless prevented by pathology, in which case the right hip was evaluated throughout the study. Results were scored as T score, defined as BMD at the site when compared to the young normal reference mean. Normal BMD is a T-score of -1.0 or higher.|Baseline, Month 48, 60|mITT population of SP1 population:randomized participants who took at least 1 dose of test article; had baseline BMD and at least one valid BMD while on therapy. N (number of participants analyzed)=participants evaluable for this measure.n=participants with specified baseline fracture status evaluable for each group.||Percent change||Standard Error|Least Squares Mean
712823|NCT00205777|Secondary|Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36|BMD of lumbar spine (Lu Sp) and hip (total hip [Tl Hp], femoral neck [Fe Ne] and femur trochanter [Fe Tr]) was evaluated by dual-energy x-ray absorptiometry (DXA). The left hip was evaluated unless prevented by pathology, in which case the right hip was evaluated throughout the study. Results were scored as T score, defined as BMD at the site when compared to the young normal reference mean. Normal BMD is a T-score of -1.0 or higher.|Baseline, Months 6, 12, 18, 24, 36|ITT population included all randomized participants who took at least 1 dose of test article; had baseline BMD and at least one valid BMD while on therapy. N (number of participants analyzed)=participants evaluable for this measure.n=participants with specified baseline fracture status evaluable for each group.||Percent change||Standard Error|Least Squares Mean
712824|NCT00205777|Secondary|Change From Baseline in Height at Month 84|Height (cm) was measured 3 times using standardized Harpenden stadiometer (height based on the middle stadiometer reading was recorded).|Baseline, Month 84|mITT population of SP1 population:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy. 'N' (number of participants analyzed) signifies those participants evaluable for this measure.||mm||Standard Deviation|Mean
712825|NCT00205777|Secondary|Change From Baseline in Height at Month 60|Height was measured 3 times using standardized Harpenden stadiometer (height based on the middle stadiometer reading was recorded).|Baseline, Month 60|ITT population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy. N (number of participants analyzed)=participants evaluable for this measure.||mm||Standard Error|Least Squares Mean
712826|NCT00205777|Secondary|Change From Baseline in Height at Month 36|Height was measured 3 times using standardized Harpenden stadiometer (height based on the middle stadiometer reading was recorded).|Baseline, Month 36|ITT population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy. N (number of participants analyzed)=participants evaluable for this measure.||millimeter (mm)||Standard Error|Least Squares Mean
712827|NCT00205777|Secondary|Percentage of Participants With Non-vertebral Fractures Through Month 84|Non-vertebral fractures were determined by direct questioning at each clinic visit after medication therapy begins. Osteoporosis-related, hip and wrist fractures were summarized.|Baseline through Month 84|mITT population of SP1 population:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy.||Percentage of participants||95% Confidence Interval|Number
712828|NCT00205777|Secondary|Percentage of Participants With Non-vertebral Fractures Through Month 60|Non-vertebral fractures were determined by direct questioning at each clinic visit after medication therapy begins. Osteoporosis-related, hip and wrist fractures were summarized.|Baseline through Month 60|ITT population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy.||Percentage of participants||95% Confidence Interval|Number
712829|NCT00205777|Secondary|Percentage of Participants With Non-vertebral Fractures Through Month 36|Non-vertebral fractures were determined by direct questioning at each clinic visit after medication therapy begins. Osteoporosis-related, hip and wrist fractures were summarized.|Baseline through Month 36|ITT population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy.||Percentage of participants||95% Confidence Interval|Number
712919|NCT00207142|Secondary|Change From Baseline in CD4 Cell Count at Week 48 of Rescue Phase|Change From Baseline in CD4 Count at Week 48 of Rescue Phase. Change=Week 48 Rescue Phase value - Baseline value; a decrease signifies worsening.|Baseline, Week 48 of Rescue Phase|Analyses use observed values (participants included are those with CD4 measurements at Baseline and Week 48 of Rescue Phase).||cells/mm3||Standard Error|Mean
712830|NCT00205777|Secondary|Number of Participants With Worsening Vertebral Fractures Through Month 84|A worsening vertebral fracture was defined as a decrease in anterior, mid, or posterior vertebral height of at least 20% and at least 4 mm as evaluated by quantitative morphometric assessment, and a grade change of at least 1 as rated by a radiologist using the semi-quantitative rating scale. It can occur only in a vertebra that was fractured at baseline.|Baseline through Month 84|mITT population of SP1 population included all randomized participants who took at least 1 dose of test article and who had a vertebral radiographic assessment at baseline and at least once while on therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||Participants|||Number
712831|NCT00205777|Secondary|Number of Participants With Worsening Vertebral Fractures Through Month 60|A worsening vertebral fracture was defined as a decrease in anterior, mid, or posterior vertebral height of at least 20% and at least 4 mm as evaluated by quantitative morphometric assessment, and a grade change of at least 1 as rated by a radiologist using the semi-quantitative rating scale. It can occur only in a vertebra that was fractured at baseline.|Baseline through Month 60|ITT population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||Participants|||Number
712832|NCT00205777|Secondary|Number of Participants With Worsening Vertebral Fractures Through Month 36|A worsening vertebral fracture was defined as a decrease in anterior, mid, or posterior vertebral height of at least 20% and at least 4 mm as evaluated by quantitative morphometric assessment, and a grade change of at least 1 as rated by a radiologist using the semi-quantitative rating scale. It can occur only in a vertebra that was fractured at baseline.|Baseline through Month 36|ITT population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||Participants|||Number
712833|NCT00205777|Secondary|Percentage of Participants With New Clinical Vertebral Fractures Through Month 84|A new clinical vertebral fracture was defined as a new fracture found at any time because of back pain suggestive of fracture(s). New Clinical vertebral fractures were verified with radiographic assessment using both semi-quantitative and quantitative morphometric assessment: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 mm or more from base to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from T4 to L4, provided vertebra was not fractured at base.|Baseline through Month 84|mITT population of SP1 population included all randomized participants who took at least 1 dose of test article and who had a vertebral radiographic assessment at baseline and at least once while on therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||Percentage of participants||95% Confidence Interval|Number
712834|NCT00205777|Secondary|Percentage of Participants With New Clinical Vertebral Fractures Through Month 60|A new clinical vertebral fracture was defined as a new fracture found at any time because of back pain suggestive of fracture(s). New Clinical vertebral fractures were verified with radiographic assessment using both semi-quantitative and quantitative morphometric assessment: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 mm or more from base to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from T4 to L4, provided vertebra was not fractured at base.|Baseline through Month 60|ITT population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||Percentage of participants||95% Confidence Interval|Number
712835|NCT00205777|Secondary|Percentage of Participants With New Clinical Vertebral Fractures Through Month 36|A new clinical vertebral fracture was defined as a new fracture found at any time because of back pain suggestive of fracture(s). New Clinical vertebral fractures were verified with radiographic assessment using both semi-quantitative and quantitative morphometric assessment: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 mm or more from base to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from T4 to L4, provided vertebra was not fractured at base.|Baseline through Month 36|ITT population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||Percentage of participants||95% Confidence Interval|Number
712836|NCT00205777|Secondary|Incidence of Breast Cancer Through Month 84|Incidence of breast cancer was defined as the number of participants with breast cancer diagnosis by the time point of interest divided by the number of participants included in the analysis. The reported rate was rescaled to reflect average follow-up time per 1000 women (1000 multiplied by number of cases divided by total follow-up time).|Baseline through Month 84|SP1 included all randomized participants who received at least 1 dose of test article. 'N' (number of participants analyzed) signifies those participants evaluable for this measure.||Breast cancer per 1000-women years|||Number
712837|NCT00205777|Secondary|Incidence of Breast Cancer Through Month 60|Incidence of breast cancer was defined as the number of participants with breast cancer diagnosis by the time point of interest divided by the number of participants included in the analysis. The reported rate was rescaled to reflect average follow-up time per 1000 women (1000 multiplied by number of cases divided by total follow-up time).|Baseline through Month 60|SP1 included all randomized participants who received at least 1 dose of test article. 'N' (number of participants analyzed) signifies those participants evaluable for this measure.||Breast cancer per 1000-women years|||Number
712838|NCT00205777|Secondary|Incidence of Breast Cancer Through Month 36|Incidence of breast cancer was defined as the number of participants with breast cancer diagnosis by the time point of interest divided by the number of participants included in the analysis. The reported rate was rescaled to reflect average follow-up time per 1000 women (1000 multiplied by number of cases divided by total follow-up time).|Baseline through Month 36|Safety Population 1 (SP1) included all randomized participants who received at least 1 dose of test article. 'N' (number of participants analyzed) signifies those participants evaluable for this measure.||Breast cancer per 1000-women years|||Number
712839|NCT00205777|Primary|Percentage of Participants With New Vertebral Fractures Through Month 84|New vertebral fracture: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 millimeter (mm) or more from baseline (base) to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from fourth thoracic to fourth lumbar vertebra (T4 to L4), provided vertebra was not fractured at base. Participant was counted only once irrespective of how many new vt fractures were diagnosed. Stratification factor was base fracture status, categorized as no prevalent fracture and at least 1 prevalent fracture.|Baseline through Month 84|Modified ITT(mITT) population of safety population category one(SP1) population:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy.N (number of participants analyzed)=participants evaluable.n=participants with specified baseline fracture status.||Percentage of participants||95% Confidence Interval|Number
712840|NCT00205777|Primary|Percentage of Participants With New Vertebral Fractures Through Month 60|New vertebral fracture: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 millimeter (mm) or more from baseline (base) to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from fourth thoracic to fourth lumbar vertebra (T4 to L4), provided vertebra was not fractured at base. Participant was counted only once irrespective of how many new vt fractures were diagnosed. Stratification factor was base fracture status, categorized as no prevalent fracture and at least 1 prevalent fracture.|Baseline through Month 60|ITT population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy.N (number of participants analyzed)=participants evaluable for this measure.n=participants with specified baseline fracture status evaluable for each group.||Percentage of participants||95% Confidence Interval|Number
712841|NCT00205777|Primary|Percentage of Participants With New Vertebral Fractures Through Month 36|New vertebral fracture: decrease in anterior, mid, or posterior vertebral (vt) height of approximately 20% and 4 millimeter (mm) or more from baseline (base) to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from fourth thoracic to fourth lumbar vertebra (T4 to L4), provided vertebra was not fractured at base. Participant was counted only once irrespective of how many new vt fractures were diagnosed. Stratification factor was base fracture status, categorized as no prevalent fracture and at least 1 prevalent fracture.|Baseline through Month 36|Intent-to-treat(ITT) population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy.N (number of participants analyzed)=participants evaluable for this measure.n=participants with specified baseline fracture status evaluable for each group.||Percentage of participants||95% Confidence Interval|Number
712842|NCT00205803|Secondary|Geometric Mean Antibody Titer (OPA) in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose|Antibody functionality/geometric mean titer (GMT) as measured by opsonophagocytic activity assay (OPA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) were assessed. Results are reported for the serotypes with a determinate antibody titer.|One month after the Toddler Dose (13 to 16 months of age)|All-available (per protocol) population consisting of eligible participants who had at least 1 valid and determinate assay result related to the proposed analysis; (n)=number of participants with a determinant antibody titer for the specified serotype.||titer||95% Confidence Interval|Geometric Mean
712843|NCT00205803|Secondary|Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose|Percentage of participants achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were assessed. Results are reported for the serotypes with a determinate antibody titer.|One month after the toddler dose (13 to 16 months of age)|All-available (per protocol) population consisting of eligible participants who had at least 1 valid and determinate assay result related to the proposed analysis; (n)= number of participants with determinant posttoddler dose antibody titer to the given serotype.||Percentage of participants||95% Confidence Interval|Number
712844|NCT00205803|Secondary|Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series|Percentage of participants achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|one month after the infant series (7 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations;(n)=number of participants with a determinate postinfant series antibody titer to the given serotype.||Percentage of participants||95% Confidence Interval|Number
712845|NCT00205803|Secondary|Geometric Mean Antibody Concentration of Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series||one month after the infant series (7 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N)= number of participants with a determinate antibody concentration for the specified concomitant vaccine component.||EU/mL||95% Confidence Interval|Geometric Mean
712846|NCT00205803|Secondary|Geometric Mean Antibody Concentration of Polio in 13vPnC Group Relative to 7vPnC Group After the Infant Series||one month after the infant series (7 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n)= number of participants with a postinfant series blood sample.||titer||95% Confidence Interval|Geometric Mean
712847|NCT00205803|Secondary|Geometric Mean Antibody Concentration Diphtheria Toxoid and Anti-Tetanus Toxoid in 13vPnC Group Relative to 7vPnC Group After the Infant Series||one month after the infant series (7 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N)=number of participants with a determinate antibody concentration for the specified concomitant vaccine component.||IU/mL||95% Confidence Interval|Geometric Mean
712848|NCT00205803|Secondary|Geometric Mean Antibody Concentration of Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series|GMCs of anti-hepatitis B surface antigen (HBsAg) using a Food and Drug Administration (FDA) approved in vitro diagnostic kit are presented.|one month after the infant series (7 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N)=number of participants with a determinate antibody concentration for the specified concomitant vaccine component.||milli International Units (mIU)/mL||95% Confidence Interval|Geometric Mean
712849|NCT00205803|Secondary|Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the Infant Series||one month after the infant series (7 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N)= number of participants with a determinate antibody concentration for the specified concomitant vaccine component.||μg/mL||95% Confidence Interval|Geometric Mean
712850|NCT00205803|Secondary|Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series|Percentage of participants achieving predefined antibody threshold levels for Haemophilus Influenzae Type b (Hib) polyribosylribitol phosphate (PRP), Diphtheria Toxoid, Polio (Types 1, 2, and 3), Pertussis (filamentous hemagglutinin [FHA], Pertussis Toxoid, and Pertactin), Tetanus, and Hepatitis B with the corresponding 95% CI for each concomitant antigen are presented.|One month after the infant series (7 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations;(n)=number of participants with a determinate postinfant series antibody level to the given concomitant vaccine component.||Percentage of participants||95% Confidence Interval|Number
712851|NCT00205803|Secondary|Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose|Antibody geometric mean concentration (GMC) as measured by ELISA with their corresponding 95% CI immediately before and after the toddler dose for 7 common pneumococcal serotypes (Serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|Immediately before (12 to 15 months of age) and one month after the toddler dose (13 to 16 months of age)|All-Available Toddler Immunogenicity population consisted of eligible participants who had at least 1 valid and determinate assay result related to proposed analysis;(n)= number of participants with a determinate antibody concentration for the specified serotype.||μg/mL||95% Confidence Interval|Geometric Mean
712852|NCT00205803|Secondary|Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series|Antibody geometric mean concentration (GMC) as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC ratios (13vPnC/7vPnC) and corresponding 2-sided 95% CI were evaluated.|One month after 3-dose infant series (at 7 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations;(n)=number of participants with a determinate antibody concentration for the specified serotype.||μg/mL||95% Confidence Interval|Geometric Mean
712853|NCT00205803|Secondary|Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose|Percentages of participants achieving WHO predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.|One month after the toddler dose (at 13 to 16 months of age)|The All-Available Toddler Immunogenicity population consisted of eligible participants who had at least 1 valid and determinate assay result related to the proposed analysis; (n)=number of participants with a determinate posttoddler dose IgG antibody concentration to the given serotype.||percentage of participants||95% Confidence Interval|Number
712854|NCT00205803|Primary|Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series|Percentage of participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.|one month after 3-dose infant series (at 7 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n)=number of participants with a determinate postinfant series IgG antibody concentration to the given serotype.||percentage of participants||95% Confidence Interval|Number
712855|NCT00205803|Primary|Percentage of Participants Reporting Pre-Specified Systemic Events|Systemic events (fever [Fv] ≥ 38 degrees Celsius [C] but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased (decr.) appetite, irritability, increased sleep, decreased sleep, use of medication (Med.)to prevent symptoms (sx), and use of medication to treat symptoms) were reported using a paper worksheet. Participants may be represented in more than 1 category.|Within 15 days after each dose|The safety population included all participants who received at least 1 dose of vaccine; (n)=number of participants with known values.||percentage of participants|||Number
712856|NCT00205803|Primary|Percentage of Participants Reporting Pre-Specified Local Reactions|Local reaction events were collected using a paper worksheet. Tenderness was scaled as Any (tenderness present); Significant (Sig.) (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (Mod.)(2.5 to 7.0 cm); Severe (Sev.)(> 7.0 cm). Participants may be represented in more than 1 category.|Within 15 days after each dose|The safety population included all participants who received at least 1 dose of vaccine;(n)=number of participants with known values.||percentage of participants|||Number
712857|NCT00205855|Primary|Change in Visual Analog Scale (VAS) Score From Baseline to 2 Week Post Initial Fitting.|"The VAS score is rated by the patient for the average pain level within the past 7 days where on a scale of 0 to 10, 0 is equal tono pain and 10 is equal to worst pain imaginable. This measurement is captured at baseline and again at 2 weeks post intitial fitting. The measurement is the percent difference between the VAS at 2 weeks post intital fitting from the baseline VAS."|2 weeks post initial fitting|||participants with > 50% VAS improvement|||Number
712858|NCT00205881|Secondary|HINT Sentences in Noise|20 sentences presented in noise at fixed levels|8 months of bilateral cochlear implant use||||||
712859|NCT00205881|Primary|Comparison of Pre-implant Consonant-Nucleus-Consonant (CNC) Scores to Post-implant CNC Scores in Bilateral Users.|Participants were tested on 50 monosyllabic, phonetically balanced words from the Consonant-Nucleus-Consonant (CNC) set, prior to implantation and after bilateral implantation. Percent correct scores for the CNC test are reported.|8 months of bilateral cochlear implant use|Adults with severe-to-profound hearing loss who received bilateral cochlear implants in the same operation.||percent of words correct||Standard Deviation|Mean
712860|NCT00206076|Secondary|Number of Participants With Adverse Events Including Infections at 12 Months||12 months|everyone enrolled who completed the study||participants|||Number
712861|NCT00206076|Secondary|Patient and Graft Survival at 12 Months||12 months|everyone enrolled who completed the study||participants|||Number
712862|NCT00206076|Primary|Number of Biopsy Proven Rejections at 12 Months|assessed by liver biopsy using Banff International Consensus Schema|12 months|||participants|||Number
712863|NCT00206102|Secondary|Number of Participants With Potential Extrapyramidal Symptoms (EPS)|Number of participants with adverse events potentially associated with EPS collected by MedDRA Preferred Terms as akathisia, bradykinesia, drooling, dyskinesia, dystonia, extrapyramidal disorder, grimacing, muscle rigidity, parkinsonism, restlessness, tardive dyskinesia, tremor|From start of the study treatment to last dose plus 30 days|The Safety analysis set included all randomized participants who received at least 1 dose of study medication||Participants|||Number
712864|NCT00206102|Secondary|Change in Abnormal Involuntary Movement Scale (AIMS) Total Score|AIMS total score is the sum of the 10 individual-item scores(range:0-40), with the score for each item ranging from 0 to 4. Change : total score at month 24 minus total score at randomization. Increase in Change of total score indicates an increase in abnormal voluntary movements. The lower score means lower intensity of abnormal voluntary Movements. 0 is best, 4 is worst. Increase in Change of total score indicates an increase in abnormal voluntary Movements.|Randomization to Month 24|The Safety analysis set included all randomized participants who received at least 1 dose of study medication||units on scale||Standard Deviation|Mean
712865|NCT00206102|Secondary|Change in Barnes Akathisia Rating Scale (BARS) Global Score|BARS global score is the 4th individual-item score on the BARS scale, the Global Assessment of Akathisia, with the score ranging from 0 (no evidence of akathisia) to 5 (severe akathisia). Change : score at month 24 minus score at randomization. Increase in Change of BARS global score indicates an increase in akathisia.|Randomization to Month 24|The Safety analysis set included all randomized participants who received at least 1 dose of study medication||units of scale||Standard Deviation|Mean
712866|NCT00206102|Secondary|Change in Simpson-Angus Scale (SAS) Total Score|SAS total score is the sum of the 10 individual-item scores (range:0-40), with the score for each item ranging from 0 to 4, higher scores indicate greater severity of Parkinsonian symptoms. Change : total score at month 24 minus total score at randomization. Increase in Change of total score indicates an increase in extrapyramidal motor symptoms.|Randomization to Month 24|The Safety analysis set included all randomized participants who received at least 1 dose of study medication||units on scale||Standard Deviation|Mean
712867|NCT00206102|Secondary|Number of Relapses of Schizophrenia or Schizoaffective Disorder|Relapse is defined as a hospital stay for psychiatric symptoms or a 2-point increase from baseline in the CGI severity score. CGI-S score ranges from 0-7 with 0 = Not Assessed, 1 = Normal, not at all and 7 = Among the most extremely ill subjects.|At Month 24|The intention-to-treat for psychiatric assessments (ITTP) analysis included all randomized participants who had a valid baseline and at least 1 post baseline assessment of PANSS total score, and received at least 1 dose of study medication.||Relapses|||Number
712868|NCT00206102|Secondary|Change in Personal Evaluation of Transitions in Treatment (PETiT) Total Score|PETiT total score is the sum of the 30 items of PETiT questionnaire(range:0-60) on subjects perceived well-being, adherence, tolerability, satisfaction with treatment. Each item is rated by participant with a 3 point frequency scale:2=often, 1=sometimes, 0=never.Change in PETiT total score: total score at month 24 minus total score at randomization|Randomization to Month 24|The intention-to-treat for psychiatric assessments (ITTP) analysis included all randomized participants who had a valid baseline and at least 1 post baseline assessment of PANSS total score, and received at least 1 dose of study medication.||units on scale||Standard Deviation|Mean
712869|NCT00206102|Secondary|Change in Health-related Quality of Life as Measured by Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q SF) Total Score|Q-LES-Q total score is the sum of the 16 times of Q-LES-Q SF(range:16-80).Each item has a 5 point satisfaction level scale:from 1=very poor(worst value) to 5=very good(best).Larger values indicate a higher perceived quality of life enjoyment and satisfaction.Change in Q-LES-Q total score:total score at month 24 minus total score at randomization|Randomization to Month 24|The intention-to-treat for psychiatric assessments (ITTP) analysis included all randomized participants who had a valid baseline and at least 1 post baseline assessment of PANSS total score, and received at least 1 dose of study medication.||units on scale||Standard Deviation|Mean
712870|NCT00206102|Secondary|Change in the Clinical Global Impression - Severity of Illness (CGI-S) Score|CGI-S score is accessed on a seven-graded scale ranging from most extremely ill/ very much worse (7) to normal/very much improved (1) , 1 is best. Change : score at month 24 minus score at randomization.|Randomization to Month 24|The intention-to-treat for psychiatric assessments (ITTP) analysis included all randomized participants who had a valid baseline and at least 1 post baseline assessment of PANSS total score (not related to CGI-S), and received at least 1 dose of study medication.||units on scale||Standard Deviation|Mean
712920|NCT00207142|Secondary|Change From Baseline in CD4 Cell Count at Week 24 of Induction Phase|Change From Baseline in CD4 Count at Week 24 of Induction Phase. Change=Week 24 Induction Phase value - Baseline value; a decrease signifies worsening.|Baseline, Week 24 of Induction Phase|Analyses use observed values (participants included are those with CD4 measurements at Baseline and at the end of Induction Phase).||cells/mm3||Standard Error|Mean
712871|NCT00206102|Secondary|Change in the PANSS Psychopathology Subscale Score|"PANSS psychopathology subscale score equals sum of the 16-items scores(range:16-112). Each item has ( 1-7 units),1= absent psychosis symptom, 7= extreme symptom degree.Change in PANSS psychopathology subscale:score at month 24 minus score at randomization. Alleviation of general psychopathology symptoms are indicated by a negative change score."|Randomization to Month 24|The intention-to-treat for psychiatric assessments (ITTP) analysis included all randomized participants who had a valid baseline and at least 1 post baseline assessment of PANSS total score, and received at least 1 dose of study medication.||units on scale||Standard Deviation|Mean
712872|NCT00206102|Secondary|Change in the PANSS Negative Subscale Score|"PANSS Negative subscale score equals sum of the 7-items scores(range:7-49). Each item has ( 1-7 units), 1 indicates absent psychosis symptom, and 7 - extreme symptom degree. Change in PANSS Negative subscale score:score at month 24 minus score at randomization. Alleviation of negative psychotic symptoms are indicated by a negative change score."|Randomization to Month 24|The intention-to-treat for psychiatric assessments (ITTP) analysis included all randomized participants who had a valid baseline and at least 1 post baseline assessment of PANSS total score, and received at least 1 dose of study medication.||units on scale||Standard Deviation|Mean
712873|NCT00206102|Secondary|Change in the PANSS Positive Subscale Score|"PANSS Positive subscale score equals sum of the 7-items scores(range:7-49). Each item has ( 1-7 units), 1 indicates absent psychosis symptom, and 7 - extreme symptom degree."|Randomization to Month 24|The intention-to-treat for psychiatric assessments (ITTP) analysis included all randomized participants who had a valid baseline and at least 1 post baseline assessment of PANSS total score, and received at least 1 dose of study medication.||units on scale||Standard Deviation|Mean
712874|NCT00206102|Secondary|Change in the Positive and Negative Syndrome Scale (PANSS) Total Score|"PANSS total score equals sum of the 30-items scores (range: 30-210). Each item has ( 1-7 units), 1 indicates absent psychosis symptom, and 7 - extreme symptom degree. Change in PANSS total score : total score at month 24 minus total score at randomization.Alleviation of psychotic symptoms are indicated by a negative change in PANSS total score."|Randomization to Month 24|The intention-to-treat for psychiatric assessments (ITTP) analysis included all randomized participants who had a valid baseline and at least 1 post baseline assessment of PANSS total score, and received at least 1 dose of study medication.||units on scale||Standard Deviation|Mean
712875|NCT00206102|Primary|Presence of a Posterior Subcapsular (P) Type Cataractogenic Potential Events in Participants as Assessed and Agreed by 2 Independent, Treatment-masked Ophthalmologists Using the LOCS II Grading Scale|Presence of P type of cataractogenic potential event in participant was defined if any LOCS II grades of 1, 2, 3 , 4 (with grade=0 at randomization) assessed and agreed by 2 independent, treatment-masked ophthalmologists at any post-randomization assessment in one or both eyes. 0 is the best, 4 is the worst.|Randomization to Month 24|The 2-year eye per protocol (E2PP) analysis included all randomized participants who met eye eligibility, had a valid baseline LOCS II evaluation, had reached the study endpoint of either a LOCS II identified cataractogenic potential event or dosed for 21 months without a LOCS II event, and had no major protocol deviations.||Participants with P type event|||Number
712876|NCT00206102|Primary|Presence of a Nuclear Opalescence (N) Type of Cataractogenic Potential Events in Participants as Assessed and Agreed by 2 Independent, Treatment-masked Ophthalmologists Using the LOCS II Grading Scale|Presence of N type of cataractogenic potential event in Participants was defined if any LOCS II grades of 2, 3, 4 (with grade at rand equals 0,1), or if the LOCS II grades of 3,or 4 (with grade at randomization=2) assessed and agreed by 2 independent, treatment-masked ophthalmologists at any post-randomization assessment in one or both eyes. 0 is the best, 4 is the worst.|Randomization to Month 24|The 2-year eye per protocol (E2PP) analysis included all randomized participants who met eye eligibility, had a valid baseline LOCS II evaluation, had reached the study endpoint of either a LOCS II identified cataractogenic potential event or dosed for 21 months without a LOCS II event, and had no major protocol deviations.||Participants with N type event|||Number
712877|NCT00206102|Primary|Presence of a Cortical (C) Type of Cataractogenic Potential Events in Participants as Assessed and Agreed by 2 Independent, Treatment-masked Ophthalmologists Using the Lens Opacities Classification System II (LOCS II ) Grading Scale|Presence of C type of cataractogenic potential event in participant was defined if any LOCS II grades of 2, 3, 4, 5 (with any grade of 0, trace,1 at randomization) assessed and agreed by 2 independent, treatment-masked ophthalmologists at any post-randomization assessment in one or both eyes. 0= no cataract; 5 is worst. There are no subscales. 0 is the best, 5 is the worst.|Randomization to Month 24|The 2-year eye per protocol (E2PP) analysis included all randomized participants who met eye eligibility, had a valid baseline LOCS II evaluation, had reached the study endpoint of either a LOCS II identified cataractogenic potential event or dosed for 21 months without a LOCS II event, and had no major protocol deviations.||Participants with C type event|||Number
712878|NCT00206427|Primary|Clinical Response|Clinical efficacy was assessed by bidimensional tumor measurements of the primary cancer at baseline, and at the end of week 6. Clinical complete response (cCR) was defined as complete disappearance of the primary tumor. Clinical partial response (cPR) was defined as a decrease by at least 50% of the sum of the products of the largest perpendicular diameters. An increase of more than 25% was defined as clinical progressive disease (cPD). Any response that does not meet the definition of cCR, cPR, or cPD was defined as stable disease (cSD).|at the end of week 6.|All patients finished 6-week therapy were included. Two patients dropped off therapy early were excluded.||participants|||Number
712879|NCT00206427|Secondary|If GW572016 Inhibits HER1 and HER2 Signaling in Situ.||5 years||||||
712880|NCT00206440|Secondary|Safety of Esomeprazole When Used to Decrease the Incidence,Severity and Duration of Nausea/Vomiting/Retching in Breast Cancer Patients Who Are Receiving Anthracycline-based Chemotherapy.||10 years||||||
712881|NCT00206440|Primary|Number of Times a Subject Felt Sick to Her Stomach and Number of Times a Subject Required Rescue Medication|Proportion of patients who exhibit no more than one emetic episode and who do not require rescue medication for nausea from 2-7 days following chemotherapy.|2-7 days following chemotheraphy|||Proportion of patients who exhibit no mo|||Number
712882|NCT00206518|Secondary|Overall Survival||10 years|||participants|||Number
713054|NCT00195715|Secondary|Percentage of Subjects Achieving Clinical Response 100 (CR-100)|A CR-100 is a decrease from baseline in CDAI score of 100 or more points. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.|Week 156|Intent-to-treat, Observed Cases||Percentage of participants|||Number
712884|NCT00206518|Primary|Pathological Tumor Response to Neoadjuvant Chemotherapy (Taxotere and AC)|"The patients' pathological response were assessed using Chevalier's system which graded the responses into Chevalier 1, 2, 3A, 3B, 3C, 3D, and 4, defined as:
Disappearance of all tumor either on macroscopic or microscopic assessment in both the breast and LN (pCR)
Presence of in situ carcinoma in the breast. No invasive tumor in breast and no tumor in LN (pCR)
Presence of invasive cancer with stromal alteration such as sclerosis or fibrosis (pPR) 3A: Subjectively > 75% therapeutic effect 3B: Subjectively between 50% - 75% therapeutic effect 3C: Subjectively between 25% - 50% therapeutic effect 3D: Subjectively < 25% therapeutic effect OR Grade 4
No or few modification of tumoral appearance (pNR)."|10 years|||participants|||Number
712885|NCT00206726|Secondary|Number of Participants With Minimal Residual Disease (MRD)|Presence of MRD was assessed by laboratory testing of molecular responses in blood and bone marrow samples.|When CR is confirmed|All participants for whom CR was confirmed||participants|||Number
712886|NCT00206726|Secondary|Percentage of Participants With Overall Response at Different Observation Times|Participant had either complete response (CR) or partial response (PR) at different observation times (after 90 days; after 180 days; after 270 days). PR requires for at least 2 months: 50% decrease from Baseline in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence or absence of constitutional symptoms; plus ≥1 of the following: ≥1500/μL polymorphonuclear leukocytes, >100000/μL platelets, >11.0 g/dL hemoglobin, or 50% improvement from Baseline for these parameters without transfusions, nodular CR or persistent anemia/thrombocytopenia unrelated to disease.|from first date of confirmed response until relapse, or death, or study data cutoff date, whichever is earlier|Subjects who achieved Overall Response (OR) defined as number of subjects who achieved CR + number of subjects who achieved PR||percentage of participants in response|||Number
712887|NCT00206726|Secondary|Progression-free Survival (PFS)|Percentage of participants who survived progression-free at 1 year, described as Kaplan-Meier estimate at 1 year|1 year after start of treatment|ITT population (all subjects enrolled and registered). As three subjects never received study medication, they were to be censored at day 1 for all time-to-event analyses. Thus, the Kaplan-Meier estimates beyond day one are the same for both, the ITT and the safety population.||percentage alive without progression|||Number
712888|NCT00206726|Secondary|Overall Survival (OS)|Percentage of participants alive 1 year after the first dose date, described as Kaplan-Meier estimate at 1 year|1 year after start of treatment|Safety Population (all subjects treated)||Percentage of participants alive|||Number
712889|NCT00206726|Secondary|Overall Response (OR)|Participant had either complete response (CR) or partial response (PR) at 28 days after last treatment cycle (date of OR) and at Months 2 follow-up. PR requires for at least 2 months: 50% decrease from Baseline in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence or absence of constitutional symptoms; plus ≥1 of the following: ≥1500/μL polymorphonuclear leukocytes, >100000/μL platelets, >11.0 g/dL hemoglobin, or 50% improvement from Baseline for these parameters without transfusions, nodular CR or persistent anemia/thrombocytopenia unrelated to disease.|28 days after last cycle with confirmation 2 months later|ITT Population (all subjects enrolled and registered).||Percentage of participants with CR or PR|||Number
712890|NCT00206726|Primary|Complete Response (CR)|Participants evaluated for therapeutic clinical response according to National Cancer Institute (NCI) response criteria, 28 days after 4 or 6 treatment cycles. Response confirmation involved bone marrow biopsy and aspirate performed 2 months after final treatment. CR requires for at least 2 months: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count (CBC); confirmed by bone marrow aspirate and biopsy 2 months later with lymphocytes <30% of nucleated cells and procedure repeated in 4 weeks if hypocellular.|28 days after last cycle with confirmation 2 months later|ITT population (all enrolled and registered subjects).||Percentage of participants with CR|||Number
712891|NCT00207090|Secondary|Number of Participants With Identified ECG Abnormalities|Triplicate 12-lead serial ECGs were performed pre-dose (just prior to infusion), 1.5, 3 (just prior to end of the infusion even if infusion lasted for less than or more than planned 3 hrs), 4, 6, 8 and 24 hrs after start of ixabepilone infusion. Triplicate 12-lead serial ECGs were also to be performed on the date prior to dosing at times approximating post-dose schedule (pre-dose triplicate set of ECGs also qualified as the 24-hr baseline ECGs). Normal ranges for ECG are as follows: heart rate: 40 - 125 bpm; PR: 0.1 - 0.2 msec; QRS: 0.06 - 0.12 msec; QTC: 0.3 - 0.45 msec; QT: 0.3 - 0.5 msec.|Data collected at screening, Day -1 and Day 1 (at 0, 1.5, 3, 4, 6, 8 and 24 hours) after start of infusion.|All participants treated with ixabepilone.||Participants|||Number
712892|NCT00207090|Secondary|QT Interval Corrected for Heart Rate (QTcF)|QT interval corrected for heart rate (QTcF) was assessed using triplicate 12-lead serial electrocardiograms (ECGs) that were performed at selected times after the first dose of ixabepilone without rifampin and at matched times prior to the first dose of ixabepilone. Abnormalities occurring at any time during the study were recorded.|Data collected at 0, 1.5, 3, 4, 6, 8 and 24 hours after start of infusion.|All participants treated with ixabepilone. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.||millisecond||90% Confidence Interval|Mean
712893|NCT00207090|Secondary|Number of Participants With Abnormal Physical Examination Findings|"Physical examination included height (screening only),weight,BSA,Eastern Cooperative Oncology Group Performance Status (ECOG PS),tendon reflexes,sensory function,motor strength. ECOG PS used to assess disease severity:score of 0 is fully active;1 is restricted physically strenuous activity;2 is ambulatory but unable to work;3 is capable of only limited self care;4 is completely disabled;5 is dead. Normal ranges:height:137-200cm or 54-79 inches;weight:40-135kg or 88-298 pounds (lbs);ECOG Scale:0-4. Abnormalities displayed here are those considered clinically significant by the investigator."|From screening to the off treatment visit.|All treated participants.||participants|||Number
712894|NCT00207090|Primary|Urine 6B-Hydroxycortisol to Cortisol Ratio on Day 22|The urine 6B-hydroxycortisol to cortisol ratio is a measure of hepatic CYP3A4/3A5 activity, which is a potential marker of the rate of clearance of ixabepilone. The urine 6B-hydroxycortisol to cortisol ratios were calculated on Day -1.|Day 22 (0-8 hours and 8-24 hours) during ixabepilone and rifampin co-administration.|All treated participants who were evaluable for PK analysis.||Ratio||Standard Deviation|Median
713055|NCT00195715|Secondary|Percentage of Subjects Achieving Clinical Remission|Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score of < 150. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.|Week 204|Intent-to-treat, Observed Cases||Percentage of participants|||Number
712895|NCT00207090|Secondary|Number of Participants With Clinically Meaningful Vital Signs Measures|"Vital signs were recorded throughout the study and included investigations related to body temperature, respiratory rate, seated blood pressure (systolic and diastolic), and heart rate. Normal ranges for the above are as follows: heart rate: 40 - 125 beats per minute (bpm); systolic BP: 65 - 200 millimeters of mercury (mmHg); diastolic BP: 40 - 120 mmHg; respiratory rate: 10 - 25 breaths per minute; temperature: 95 - 105F or 35 - 40.5C. The abnormalities displayed here are those considered clinically significant by the investigator and include abnormalities recorded at any time during study."|From screening to the off treatment visit.|All treated participants.||participants|||Number
712896|NCT00207090|Primary|Urine 6B-Hydroxycortisol to Cortisol Ratio on Day -1|The urine 6B-hydroxycortisol to cortisol ratio is a measure of hepatic CYP3A4/3A5 activity, which is a potential marker of the rate of clearance of ixabepilone. The urine 6B-hydroxycortisol to cortisol ratios were calculated on Day -1.|Day -1 (0-8 hours and 8-24 hours), 24 hours before starting of ixabepilone administration.|All treated participants who were evaluable for PK analysis.||Ratio||Standard Deviation|Mean
712897|NCT00207090|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC [0-T])|AUC (0-T) was obtained directly from the concentration-time data.|Blood samples were collected on Day 1 (pre-dose, then 1h30, 3h, 3h15, 3h30, 4h, 6h and 8h), Day 2, Day 3, Day 4 and Day 8 during ixabepilone administration and repeated for Cycle 2 (Days 22-25 and 29) during ixabepilone and rifampin co-administration.|All treated participants who were evaluable for PK analysis.||nanogram (ng)*hr/mL||Standard Deviation|Mean
712898|NCT00207090|Secondary|Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Calcium, Magnesium, Potassium, Sodium, Glucose and Uric Acid.|Abnormalities occurring at any time during the study were graded per NCI CTC (1=mild, 2=moderate, 3=severe, 4=life threatening). Grade 3 and 4 criteria were as follows:Calcium: Grade 3: 6-<7 or >12.5-13.5mg/dL, Grade 4:<6 or >13.5mg/dL. Magnesium: Grade 3:0.6-<0.8 or >2.46-6.6mEq/L, Grade 4:<0.6 or >6.6mEq/L. Potassium: Grade 3:2.5-<3 or >6-7mmol/L, Grade 4:<2.5 or >7.0 mmol/L. Sodium: Grade 3:120-<130 or >155-160 mEq/L, Grade 4:<120 or >160mEq/L. Glucose: Grade 3:30-<40 or >250-500mg/dL, Grade 4:<30 or >500mg/dL. Uric acid: Grade 3:>ULN-10mg/dL with physiologic consequences, Grade 4:>10mg/dL.|Screening, Days 2 and 22.|All treated participants.||Participants|||Number
712899|NCT00207090|Primary|Time to Reach Maximum Observed Concentration (T Max)|T max was obtained directly from the concentration-time data.|Blood samples were collected on Day 1 (pre-dose, then 1h30, 3h, 3h15, 3h30, 4h, 6h and 8h), Day 2, Day 3, Day 4 and Day 8 during ixabepilone administration and repeated for Cycle 2 (Days 22-25 and 29) during ixabepilone and rifampin co-administration.|All treated participants who were evaluable for PK analysis.||Hrs||Full Range|Median
712900|NCT00207090|Primary|Volume of Distribution at Steady-state (Vss)|Vss was obtained directly from the concentration-time data.|Blood samples were collected on Day 1 (pre-dose, then 1h30, 3h, 3h15, 3h30, 4h, 6h and 8h), Day 2, Day 3, Day 4 and Day 8 during ixabepilone administration and repeated for Cycle 2 (Days 22-25 and 29) during ixabepilone and rifampin co-administration.|All treated participants who were evaluable for PK analysis.||L||Standard Deviation|Mean
712901|NCT00207090|Primary|Total Body Clearance (CLT)|CLT was obtained directly from the concentration-time data.|Blood samples were collected on Day 1 (pre-dose, then 1h30, 3h, 3h15, 3h30, 4h, 6h and 8h), Day 2, Day 3, Day 4 and Day 8 during ixabepilone administration and repeated for Cycle 2 (Days 22-25 and 29) during ixabepilone and rifampin co-administration.|All treated participants who were evaluable for PK analysis.||Litres(L)/hr||Standard Deviation|Mean
712902|NCT00207090|Primary|Mean Residence Time Adjusted for Infusion Time (MRT [INF])|(MRT [INF]) was obtained directly from the concentration-time data.|Blood samples were collected on Day 1 (pre-dose, then 1h30, 3h, 3h15, 3h30, 4h, 6h and 8h), Day 2, Day 3, Day 4 and Day 8 during ixabepilone administration and repeated for Cycle 2 (Days 22-25 and 29) during ixabepilone and rifampin co-administration.|All treated participants who were evaluable for PK analysis.||Hrs||Standard Deviation|Mean
712903|NCT00207090|Primary|Time Taken for Plasma Concentration to Reduce by 50 Percent or Apparent Terminal Plasma Elimination Half-life (T Half)|T half was obtained directly from the concentration-time data.|Blood samples were collected on Day 1 (pre-dose, then 1h30, 3h, 3h15, 3h30, 4h, 6h and 8h), Day 2, Day 3, Day 4 and Day 8 during ixabepilone administration and repeated for Cycle 2 (Days 22-25 and 29) during ixabepilone and rifampin co-administration.|All treated participants who were evaluable for PK analysis.||Hrs||Standard Deviation|Mean
712904|NCT00207090|Secondary|Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Alanine Aminotransferase, Aspartate Aminotransferase, Bilirubin, Albumin and Phosphorous|Abnormalities occurring at any time during the study were graded per the NCI CTC (1=mild, 2=moderate, 3=severe, 4=life threatening). Grade 3 and 4 criteria were as follows: Alanine aminotransferase, aspartate aminotransferase and alkaline phosphatase: Grade 3: >5-20 x upper limit of normal (ULN), Grade 4: >20 x ULN. Bilirubin: Grade 3: >3-10 x ULN, Grade 4: >10 x ULN. Albumin: Grade 3: <2g/dL (Grade 4 not defined in NCI CTC). Creatinine: Grade 3: >3-6 x ULN, Grade 4: >6 x ULN. Phosphorous: Grade 3: 1-<2mg/dL, Grade 4: <1mg/dL.|Screening, Days 1 and 22.|All treated participants.||participants|||Number
712905|NCT00207090|Secondary|Number of Participants With Grade 3-4 Hematology Abnormalities|Abnormalities occurring at any time during the study were graded per NCI CTC, v3.0 criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening). Grade 3 and 4 criteria are given below. Neutrophils: Grade 3: 0.5 - <1.0x10^9/L, Grade 4: <0.5x10^9/L. Leukocytes: Grade 3: 1.0 - <2.0x10^9/L, Grade 4: <1.0x10^9/L. Neutrophils + bands (absolute): Grade 3: 0.5 - <1.0x10^9/L, Grade 4: <0.5x10^9/L. Hemoglobin: Grade 3:6.5 - <8.0g/dL, Grade 4: <6.5g/dL. Lymphocytes: Grade 3: 0.2 - <0.5x10^9/L, Grade 4: <0.2x10^9/L. Platelets: Grade 3: 25.0 - <50.0x10^9/L, Grade 4: <25.0x10.|Screening, Day 1, Day 8, Day 15, Day 22 and Day 29-36.|All treated participants.||participants|||Number
712906|NCT00207090|Secondary|Number of Participants Who Died and Who Experienced Other Serious AEs (SAEs), Grade 3-4 AEs, Drug-related AEs and AEs Leading to Study Drug Discontinuation|AEs:new untoward medical occurrences/worsening of pre-existing medical condition,whether or not related to study drug.SAE:AE resulting in death;life threatening;resulted in persistent/significant disability/incapacity;resulted in/prolonged existing hospitalization;a congenital anomaly/birth defect;overdose.Drug-related AEs: relationship to drug of certain;probable;possible;or missing.Participants who discontinued study due to AE were also recorded.AEs graded using National Cancer Institute (NCI) Common Toxicity Criteria (CTC),v3:Grade 1=mild,2=moderate, 3=severe,4=life threatening,5=death.|From Day 1 to 30 days after the last dose of study drug.|All treated participants.||participants|||Number
712907|NCT00207090|Primary|Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC [INF])|AUC (INF) was obtained directly from the concentration-time data.|Blood samples were collected on Day 1 (pre-dose, then 1h30, 3h, 3h15, 3h30, 4h, 6h and 8h), Day 2, Day 3, Day 4 and Day 8 during ixabepilone administration and repeated for Cycle 2 (Days 22-25 and 29) during ixabepilone and rifampin co-administration.|All treated participants who were evaluable for PK analysis.||nanogram (ng)*hour(hr)/mL||90% Confidence Interval|Geometric Mean
712908|NCT00207090|Primary|Maximum Plasma Concentration (Cmax)|Cmax was obtained directly from the concentration-time data.|Blood samples were collected on Day 1 (pre-dose, then 1h30, 3h, 3h15, 3h30, 4h, 6h and 8h), Day 2, Day 3, Day 4 and Day 8 during ixabepilone administration and repeated for Cycle 2 (Days 22-25 and 29) during ixabepilone and rifampin co-administration.|Of the 15 patients in each group, only those with evaluable pharmacokinetic (PK) results are presented.||nanogram (ng)/millilter(mL)||90% Confidence Interval|Geometric Mean
712909|NCT00207142|Secondary|Percent Change From End of Induction Phase in Fasting Lipids at Week 48 of Maintenance Phase|Percent change in fasting lipids from end of Induction Phase to Week 48 of Maintenance Phase.Percent changes were calculated on the log scale and then back transformed to the original scale.Change=Week 48 maintenance Phase value - end of Induction Phase value; a decrease signifies worsening for HDL cholesterol and improvement for all other lipds.|Measurements were included from the end of Induction Phase (Week 26 to Week 30 of Induction therapy) through Week 48 of Maintenance Phase.|Participants who received at least 1 dose of Maintenance Phase study therapy. As-treated population (as-treated refers to the actual treatment received during the Maintenance Phase). Analysis used last observation carried forward (LOCF) to replace missing values.||percent change||95% Confidence Interval|Mean
712910|NCT00207142|Secondary|Summary of Adverse Events During Rescue Phase|Summary of Adverse Events (AEs), Deaths, Serious AEs (SAEs), and AEs leading to study discontinuation. An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|Measurements are included from the end of Induction Phase (26 to 30 weeks after the first dose therapy) through the last dose of Rescue Phase study therapy plus 30 days.|Participants who received at least 1 dose of Rescue Phase study therapy||Participants|||Number
712911|NCT00207142|Secondary|Summary of Adverse Events During Maintenance Phase|Summary of Adverse Events (AEs), Deaths, Serious AEs (SAEs), and AEs leading to study discontinuation. An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|Measurements are included from the end of Induction Phase (26 to 30 weeks after first dose) through the last dose of Maintenance Phase study therapy plus 30 days.|Participants who received at least 1 dose of Maintenance Phase study therapy. As-treated population (as-treated refers to the actual treatment received during the Maintenance Phase).||Participants|||Number
712912|NCT00207142|Secondary|Summary of Adverse Events During Induction Phase|Summary of Adverse Events (AEs), Deaths, Serious AEs (SAEs), and AEs leading to study discontinuation. An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|Measurements are included through the earlier of the last dose of Induction Phase study therapy plus 30 days or the first dose of Maintenance/Rescue Phase therapy (ie, up until 26 to 31 weeks + 30 days).|Participants who received at least 1 dose of Induction Phase study therapy.||Participants|||Number
712913|NCT00207142|Secondary|Time to Suppression (Confirmed HIV-1 RNA < 400 c/mL) During Treatment Phase|Time to suppression was measured from the first dose of Induction Phase study therapy to the first of the 2 consecutive measurements <400 c/mL. Time to suppression was analyzed using life tables. Measured Values show the Kaplan-Meier cumulative number of treated participants without suppression up to the end of the respective interval.|Week 16-18, Week 24-26, Week 30-32|||Participants|||Number
712914|NCT00207142|Secondary|Time to Suppression (Confirmed HIV-1 RNA < 50 c/mL) During Treatment Phase|Description: Time to suppression was measured from the first dose of Induction Phase study therapy to the first of the 2 consecutive measurements < 50 c/mL. Time to suppression was analyzed using life tables. Measured Values show the Kaplan-Meier cumulative number of treated participants without suppression up to the end of the respective interval.|Week 16-18, Week 24-26, Week 38-40, Week 64-66|||Participants|||Number
712915|NCT00207142|Secondary|Treatment Outcomes Based on Viral Loads (HIV-1 RNA ≥400 c/mL) Through the End of Rescue Phase|Treatment outcome is based on the first reason of failure. These analyses were performed using HIV-1 RNA of 400 c/mL to define suppression and virologic rebound.|Baseline, Week 48 of Rescue Phase|||Participants|||Number
712916|NCT00207142|Secondary|Treatment Outcomes Based on Viral Loads (HIV-1 RNA ≥50 c/mL) Through the End of Rescue Phase|Treatment outcome is based on the first reason of failure. These analyses were performed using HIV-1 RNA of 50 c/mL to define suppression and virologic rebound.|Through Week 48 of Rescue Phase. Measurements were included from the end of Induction Phase through the last dose of Rescue Phase study therapy plus 4 days.|||Participants|||Number
712917|NCT00207142|Secondary|Change From Baseline in HIV-1 RNA at Week 48 of the Rescue Phase|Change From Baseline in HIV-1 RNA at Week 48 of the Rescue Phase. Change=Week 48 Rescue Phase value - Baseline value; a decrease signifies improvement.|\Baseline, Week 48 of Rescue Phase|Analyses use observed values (participants included are those with HIV-1 RNA measurements at baseline and at Week 48 of Rescue Phase)||log10 c/mL||Standard Error|Mean
713058|NCT00195715|Secondary|Percentage of Subjects Achieving Clinical Remission|Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score of < 150. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.|Week 48|Intent-to-treat, Observed Cases||Percentage of participants|||Number
712921|NCT00207142|Secondary|Change From End of Induction Phase in CD4 Cell Count at Week 48 of Maintenance Phase|Change in CD4 Cell Count From End of Induction Phase at Week 48 of Maintenance Phase. Change=Week 48 maintenance Phase value - end of Induction Phase value; a decrease signifies worsening.|End of Induction Phase (Week 26 to Week 30 of Induction Phase treatment), Week 48 of Maintenance Phase|As-randomized population (as-randomized refers to the treatment regimen assigned at randomization). Analysis uses observed values (participants included are those with CD4 measurements at end of Induction Phase and at Week 48 of Maintenance Phase).||cells/mm3||Standard Error|Mean
712922|NCT00207142|Secondary|Kaplan-Meier Cumulative Proportion for Treatment Failure (HIV-1 RNA ≥400 c/mL) at Different Time Points Through Week 48 of the Maintenance Phase|Treatment failure based on HIV-1 RNA ≥ 400 c/mL was defined as virologic rebound on or before Week 48 or discontinuation of study therapy before Week 48 for any reason. Time to treatment failure was analyzed using life tables. Measured Values shows the Kaplan-Meier cumulative proportion of participants without treatment failure up to the end of the respective interval.|Weeks 6-8, Weeks 14-16, Weeks 22-24, Weeks 30-32, Weeks 38-40, Weeks 46-48|As-randomized population. (As-randomized refers to the treatment regimen assigned at randomization.)||Proportion of participants|||Number
712923|NCT00207142|Secondary|Kaplan-Meier Cumulative Proportion for Treatment Failure (HIV-1 RNA ≥50 c/mL) at Different Time Points Through Week 48 of the Maintenance Phase|Treatment failure based on HIV-1 RNA ≥ 50 c/mL was defined as virologic rebound on or before Week 48 or discontinuation of study therapy before Week 48 for any reason. Time to treatment failure was analyzed using life tables. Measured Values shows the Kaplan-Meier cumulative proportion of participants without treatment failure up to the end of the respective interval.|Weeks 6-8, Weeks 14-16, Weeks 22-24, Weeks 30-32, Weeks 38-40, Weeks 46-48|As-randomized population (as-randomized refers to the treatment regimen assigned at randomization).||Proportion of participants|||Number
712924|NCT00207142|Secondary|Percentage of Participants With HIV-1 RNA <400 c/mL Through Week 48 of the Maintenance Phase|Participants were considered successes unless they experienced treatment failure, or had missing Week 48 HIV-1 RNA. Treatment failure: virologic rebound (ie, 2 consecutive on-treatment HIV-1 RNA ≥ 400 c/mL, or last HIV-1 RNA ≥ 400 c/mL followed by discontinuation), or discontinuation before Week 48. Denominator included all randomized participants.|From the end of Induction Phase (Week 26 to Week 30 of Induction Phase treatment) through Week 48 of Maintenance Phase|As-randomized population. (As-randomized refers to the treatment regimen assigned at randomization.)||Percentage of participants|||Number
712925|NCT00207142|Primary|Percentage of Participants With HIV-1 RNA <50 Copies/mL (c/mL) Through Week 48 of the Maintenance Phase|Participants were considered successes unless they experienced treatment failure, or had missing Week 48 HIV-1 RNA. Treatment failure: virologic rebound (ie, 2 consecutive on-treatment HIV-1 RNA ≥ 50 c/mL, or last HIV-1 RNA ≥ 50 c/mL followed by discontinuation), or discontinuation before Week 48. Denominator included all randomized participants.|From the end of Induction Phase (Week 26 to Week 30 of Induction Phase treatment) through Week 48 of Maintenance Phase|As-randomized population (as-randomized refers to the treatment regimen assigned at randomization).||Percentage of participants|||Number
712926|NCT00207714|Secondary|Summary of ACR-N, Index of Improvement at Week 16|The ACR-N index of improvement is the minimum of the following: 1) the percent decrease from baseline in tender joint counts; 2) the percent decrease from baseline in swollen joint counts; 3) the median percent decrease from baseline for the following: a. Patient’s assessment of pain as measured on a 10 cm visual assessment scale (0-10, 10 worst pain) Patient’s global assessment of disease activity (VAS 0-10); c. Physician’s global assessment of disease activity (VAS 0-10) d. Physical function as measured by the Health Assessment Questionnaire; e. C-Reactive Protein measurement.|Week 16|Intent-to-treat (ITT) and missing ACR components were imputed by LOCF unless all ACR components are missing in which case considered non-responders. The joint evaluability rules were also applied.||Scores on scale||Inter-Quartile Range|Median
712927|NCT00207714|Primary|Number of Participants Meeting the American College of Rheumatology 20 (ACR 20) Response at Week 16|ACR 20 response is a decrease of at least 20 per cent in both tender and swollen joint count and in 3 to 5 assessments (participant's assessment of pain visual analog scale [VAS] with 0, no pain to 10, worst pain; patient's and physician's global assessment of disease activity VAS scales: overall disease activity [0, very well to 10, very poor and 0, no arthritis activity to 10, extremely active, respectively]; Health Assessment Questionnaire [HAQ]: 20-questions on life activities [0, no difficulty to 3, inability to perform a task]; C-reactive protein[CRP]).|Week 16|Intent to treat (ITT). Participants considered non-responder if used any pre-specified prohibited medications or discontinued subcutaneous (SC) study agent due to lack of efficacy. Missing ACR components were imputed by Last Observation Carried Forward (LOCF) unless all ACR components are missing in which case considered non-responders.||Participants|||Number
712928|NCT00207727|Secondary|Change From Baseline in Expanded Disability Status Scale (EDSS)|The EDSS is based on an independent neurologist’s examination of 8 functional systems and is used to classify multiple sclerosis (MS) severity, progression, disability, and evaluate treatment results. A numeric score ranging from 0 (normal) to 10 (death) is produced, the change from baseline of the EDSS score ranges from -9 to 10.|Baseline, Week 23|Intent to treat. Missing data was imputed. Missing EDSS scores was replaced with the last non-missing EDSS value observed (last observation carried forward).||Units on a scale||Inter-Quartile Range|Median
712929|NCT00207727|Secondary|Relapses of Multiple Sclerosis (MS) Through Week 23|Clinical relapse of MS is defined as any acute neurological event, reported by the patient, that is characterized by new or worsening signs or symptoms of MS lasting at least 48 hours after a stable period of at least 30 days that is considered, in the judgment of the study physician (treating neurologist), to be a clinical relapse of MS.|Week 23|Missing data remained missing. No treatment failure rule was implemented.||Relapses||Inter-Quartile Range|Median
712930|NCT00207727|Primary|The Cumulative Number of Newly Gadolinium-enhancing T1-weighted Lesions on Cranial Magnetic Resonance Imaging (MRI)s Through Week 23.|A newly Gadolinium (Gd) enhancing T1-weighted lesion is defined as a lesion that is enhanced on a current cranial MRI scan but was not classified as a newly Gd enhancing T1-weighted lesion on the previous MRI scan.|Week 23|Intent to treat. Missing data was imputed. The average number of newly Gd enhancing T1-weighted lesions from all valid visits for the patient will be used when prohibited medications are initiated.||Lesions||Inter-Quartile Range|Median
713366|NCT00209274|Secondary|Mitral Valve Area by Pressure Half-time|Defined as mitral valve area as measured by core lab echocardiography.|24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.||cm^2||Standard Deviation|Mean
712931|NCT00207740|Secondary|Change From Baseline in Domiciliary Morning Peak Expiratory Flow Rate (PEFR) at 6 Months; Randomized Subjects|The endpoint is the change from baseline in domiciliary morning PEFR at Week 24. PEFR— Peak Expiratory Flow Rate (PEFR): A measure of the speed of exhalation. The data were collected in the eDiary which was issued to each participant at screening. PEFR was collected morning and evening each day of the study.|Baseline to Week 24|The analysis of this endpoint uses intent-to-treat population. Missing data were imputed using last observation carried forward (LOCF).||L/min||Standard Deviation|Mean
712932|NCT00207740|Secondary|Change From Baseline in Oral Corticosteroids Dose at Week 52; Randomized Patients Who Received Oral Corticosteroids at Baseline|The endpoint is the change from baseline at Week (Wk) 52 in oral corticosteroids (OCS) dose for the randomized patients who received OCS at baseline.|Baseline and Week 52|Analysis of this endpoint includes only pts who received OCS at baseline.Wk 52 OCS dose is the daily OCS dose in the last period, defined as between 2 consecutive visits, in which no change in total daily dose of OCS occurred, prior to Wk 52 visit.Data from Wk 24-52 must be interpreted with caution as study agent was stopped at various timepoints.||mg/day P. Eq.||Inter-Quartile Range|Median
712933|NCT00207740|Secondary|Number of Severe Asthma Exacerbations Per Patient From Week 24 Through Week 52; Randomized Patients Who Did Not Discontinue Study Participation Prior to Week 24|The endpoint is the average number of severe asthma exacerbations per patient from Week (Wk) 24 through Wk 52 for the patients who did not discontinue study participation prior to Wk 24|Week 24 to Week 52|Analysis of this endpoint only includes patients (pts) who did not discontinue study participation prior to Wk 24. For the dropouts during the period between Wks 24- 52, worst case in similar pts was used as the number of severe exacerbations. Data from Wk 24-52 must be interpreted with caution as study agent was stopped at various study timepoints||Events per patient from Wk 24 thru Wk 52||Standard Deviation|Mean
712934|NCT00207740|Secondary|Change From Baseline in Rescue Medication Use at 6 Months; Randomized Patients|The endpoint is change from baseline in rescue medication use at Wk 24 where the rescue medication use was based on the average over 7 days prior to visit.|Baseline to Week 24|The analysis of this endpoint uses intent-to-treat population. Missing data were imputed using last observation carried forward.||Puffs/day||Inter-Quartile Range|Median
712935|NCT00207740|Primary|Number of Severe Asthma Exacerbations Per Patient From Baseline Through 6 Months|The endpoint is the average number of severe asthma exacerbations per patient from baseline through 6 months.|Baseline to Week 24|The analysis of this endpoint uses intent-to-treat population. For the dropouts, the worst case in similar patients was used as the number of severe exacerbations.||Events per patient through week (Wk) 24||Standard Deviation|Mean
712936|NCT00207740|Secondary|Change From Baseline in Asthma Quality of Life Questionnaire Score at 6 Months; Randomized Patients|The endpoint is the change from baseline in the overall Asthma Quality of Life Questionnaire (AQLQ) score at 6 months. The AQLQ is a validated and self-administered questionnaire to evaluate symptoms and Quality of Life (QOL) in subjects with asthma and it has 32 questions in 4 domains (symptoms, activity limitations, emotional function, and environmental stimuli). Participants were asked to score the importance of each of the positively identified problems on a 7-point scale (7 = not impaired at all - 1 = severely impaired).|Baseline to Week 24|The analysis of this endpoint uses intent-to-treat population. Missing data were imputed using last observation carried forward.||Points on scale||Inter-Quartile Range|Median
712937|NCT00207740|Primary|Change From Baseline in Prebronchodilator Clinic-Measured, Percent-Predicted Forced Expiratory Volume in 1 Second|The endpoint is change from baseline in prebronchodilator clinic-measured percent predicted Percent-Predicted Forced Expiratory Volume in 1 Second (FEV1) with Last Observation Carried Forward (LOCF) at 6 months. The baseline visit starts at the end of 2 weeks run in phase.|Baseline and Week 24|The analysis of this endpoint uses intent-to-treat population. Missing data were imputed using Last Observation Carried Forward (LOCF).||Percent predicted||95% Confidence Interval|Least Squares Mean
712938|NCT00207883|Secondary|Time to Successful Central Line Placement|Time, in seconds, till successful guide wire placement was achieved.|immediate|Critically ill children requiring central venous access.||seconds||Inter-Quartile Range|Median
712939|NCT00207883|Primary|Central Line Placement Success|Success was defined as central venous catheter being able to thread into the vessel over the guide wire.|immediate|Population consisted of critically ill children requiring placement of a central venous catheter.||participants|||Number
712950|NCT00208091|Secondary|Subjective Assessment Ratings of Change|Each subject assessed his or her music playing performance change subjectively from -100 percent (fully worse) to 100 percent (fully better).|Baseline to 6 weeks after injection|||percentage change||Standard Deviation|Mean
712951|NCT00208091|Primary|Note Errors (Related to Errors in Loudness)|Note errors (related to errors in loudness) were obtained as a measure of difference between the affected and unaffected hands--taking the musical instrument digital interface (MIDI) note loudness data (decibels) from four musical sequences of 8 to 16 notes. It was calculated by averaging sequences for each hand and taking the square root of the mean of the square of the differences (root mean square error, in decibels) in MIDI notes.|Baseline and 6 weeks post-injection|||decibels||Standard Error|Median
712952|NCT00208091|Primary|Note Errors (Related to Errors in Duration)|Note errors (related to errors in duration in msec) were obtained as measures of difference between the affected and unaffected hands--taking the musical instrument digital interface (MIDI) note output from four musical sequences of 8 to 16 notes played. It was calculated by averaging the sequences for each hand, and deriving the square root of the mean of the square of the differences (root mean square error, in msec) in MIDI.|Baseline and 6 weeks post-injection|||msec||Standard Error|Median
712953|NCT00195650|Primary|Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 260|The HAQ-DI is a measure of disability that ranges from 0 to 3. Decrease in score indicates improvement in physical function; a decrease of 0.22 or greater from Baseline score is clinically significant. Participants assessed their ability to perform at least 6 of the following 8 specific tasks (1. dress/groom; 2. arise; 3. eat; 4. walk; 5. reach; 6. grip; 7. maintain hygiene; 8. maintain daily activity) over the past week by marking their response on a questionnaire. Possible responses/scores included the following: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). The 8 task scores are added and the sum is divided by the number of tasks assessed (range = 6 to 8). This yields a HAQ-DI score of 0 to 3.|Baseline of prior Phase 1, 2, or 3 adalimumab study and Week 260|All participants who received at least 1 dose of open-label adalimumab (Full Analysis Set) in the continuation study and had a Week 260 visit. Analysis used observed data (no imputation).||units on a scale||Standard Deviation|Mean
712954|NCT00195650|Primary|Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 520|The HAQ-DI is a measure of disability that ranges from 0 to 3. Decrease in score indicates improvement in physical function; a decrease of 0.22 or greater from Baseline score is clinically significant. Participants assessed their ability to perform at least 6 of the following 8 specific tasks (1. dress/groom; 2. arise; 3. eat; 4. walk; 5. reach; 6. grip; 7. maintain hygiene; 8. maintain daily activity) over the past week by marking their response on a questionnaire. Possible responses/scores included the following: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). The 8 task scores are added and the sum is divided by the number of tasks assessed (range = 6 to 8). This yields a HAQ-DI score of 0 to 3.|Baseline of prior Phase 1, 2, or 3 adalimumab study and Week 520|All participants who received at least 1 dose of open-label adalimumab in the continuation study (Full Analysis Set) and had a Week 520 visit. Analysis used observed data (no imputation).||units on a scale||Standard Deviation|Mean
712955|NCT00195650|Primary|Number of Participants in Clinical Remission (Based on Modified Disease Activity Score) at Week 260|Clinical remission on modified Disease Activity Score (DAS28) was a value <2.6; >=2.6 to <=3.2 indicated low disease activity; >3.2 to <=5.1 indicated moderate disease activity; and >5.1 indicated high disease activity. DAS28 score is calculated using the number of tender joints and swollen joints (out of 28 each), patient global assessment of disease activity, and C-reactive protein (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response).|Week 260|All participants who received at least 1 dose of open-label adalimumab in the continuation study (Full Analysis Set) and had a Week 260 visit. Analysis used observed data (no imputation).||participants|||Number
712956|NCT00195650|Primary|Number of Participants in Clinical Remission (Based on Modified Disease Activity Score) at Week 520|Clinical remission on modified Disease Activity Score (DAS28) was a value <2.6; >=2.6 to <=3.2 indicated low disease activity; >3.2 to <=5.1 indicated moderate disease activity; and >5.1 indicated high disease activity. DAS28 score is calculated using the number of tender joints and swollen joints (out of 28 each), patient global assessment of disease activity, and C-reactive protein (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response).|Week 520|All participants who received at least 1 dose of open-label adalimumab in the continuation study (Full Analysis Set) and had a Week 520 visit. Analysis used observed data (no imputation).||participants|||Number
712957|NCT00195650|Primary|Number of Participants Meeting American College of Rheumatology 70% (ACR70) Response Criteria at Week 260|ACR70 response criteria were: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of the 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-reactive protein (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response). All improvements were assessed relative to the baseline of the prior study.|Week 260|All participants who received at least 1 dose of open-label adalimumab in the continuation study (Full Analysis Set) and had a Week 260 visit. Analysis used observed data (no imputation).||participants|||Number
712958|NCT00195650|Primary|Number of Participants Meeting American College of Rheumatology 70% (ACR70) Response Criteria at Week 520|ACR70 response criteria were: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of the 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-reactive protein (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response). All improvements were assessed relative to the baseline of the prior study.|Week 520|All participants who received at least 1 dose of open-label adalimumab in the continuation study (Full Analysis Set) and had a Week 520 visit. Analysis used observed data (no imputation).||participants|||Number
712959|NCT00195650|Primary|Number of Participants Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 260|ACR50 response criteria were: >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of the 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-reactive protein (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response). All improvements were assessed relative to the baseline of the prior study.|Week 260|All participants who received at least 1 dose of open-label adalimumab in the continuation study (Full Analysis Set) and had a Week 260 visit. Analysis used observed data (no imputation).||participants|||Number
713261|NCT00211510|Secondary|Changes in Hypoglycemia Area Under the Curve (AUC) From Baseline to Week 26|Hypoglycemia is defined as a recorded blood glucose event <70mg/dL. The amount of time spent below this parameter will be analyzed and compared between groups from Baseline to Week 26|Baseline and 26 weeks|||mmol/dl*min||Standard Deviation|Mean
712960|NCT00195650|Secondary|Reported Adverse Events|Adverse events were collected during the course of the study (after the first adalimumab injection in this continuation study DE020 through 70 days after the last adalimumab injection) for all participants who received at least 1 dose of open-label adalimumab in the continuation study (Full Analysis Set). The number of participants experiencing any adverse event (serious and non-serious) are summarized. See the Reported Adverse Events section for details.|Duration of study (up to 520 weeks [10 years])|All participants who received at least 1 dose of open-label adalimumab in the continuation study (Full Analysis Set).||participants|||Number
712961|NCT00195650|Primary|Number of Participants Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 520|ACR50 response criteria were: >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of the 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-reactive protein (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response). All improvements were assessed relative to the baseline of the prior study.|Week 520|All participants who received at least 1 dose of open-label adalimumab in the continuation study (Full Analysis Set) and had a Week 520 visit. Analysis used observed data (no imputation).||participants|||Number
712962|NCT00195650|Primary|Number of Participants Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 260|ACR20 response criteria were: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of the 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-reactive protein (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response). All improvements were assessed relative to the baseline of the prior study.|Week 260|All participants who received at least 1 dose of open-label adalimumab in the continuation study (Full Analysis Set) and had a Week 260 visit. Analysis used observed data (no imputation).||participants|||Number
712963|NCT00195650|Primary|Number of Participants Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 520|ACR20 response criteria were: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of the 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-reactive protein (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response). All improvements were assessed relative to the baseline of the prior study.|Week 520|All participants who received at least 1 dose of open-label adalimumab in the continuation study (Full Analysis Set) and had a Week 520 visit. Analysis used observed data (no imputation).||participants|||Number
712964|NCT00195663|Secondary|Number of Participants With Improvement in HAQ-DI by 0.22 and 0.5 Units Over 10 Years by Adalimumab Exposure|The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A decrease in the HAQ-DI score represents an improvement in physical function; a clinically significant improvement is defined as a decrease of least 0.22 from Baseline in the HAQ-DI score. The number of participants with improvement in HAQ-DI of at least 0.22 and 0.5 units from Baseline is reported.|Baseline and Years 1, 2, 5, and 10. Baseline was the last value prior to the first dose of adalimumab. For patients randomized to the MTX arm in the DB phase, Baseline was the last visit prior to the first adalimumab dose at Week 106.|"ITT Analysis Set, with available data. The Number of Participants Analyzed indicates patients with non-missing HAQ-DI scores at any post-baseline time point; N indicates patients with non-missing data at each specified time point."||participants|||Number
712965|NCT00195663|Secondary|Number of Participants With a Major Clinical Response Over 10 Years by Adalimumab Exposure|"A major clinical response was defined as maintenance of an ACR70 response for at least a 6-month continuous period at any time during the study following the first dose of adalimumab. A participant was a responder if the following criteria for improvement from Baseline were met:
≥ 70% improvement in tender joint count;
≥ 70% improvement in swollen joint count; and
≥ 70% improvement in at least 3 of the 5 following parameters:
Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
Patient's global assessment of disease activity (measured on a 100 mm VAS);
Physician's global assessment of disease activity (measured on a 100 mm VAS);
Patient’s self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);
Acute phase reactant value (C-Reactive Protein)."|From the first dose of adalimumab (at Week 1 or Week 106 for patients initially randomized to methotrexate in the DB phase) to Year 10|ITT Analysis Set for participants with non-missing ACR data.||participants|||Number
712966|NCT00195663|Secondary|Composite Score of ACR50 Plus No Change in Modified Total Sharp Score||Year 10|This outcome measure was not analyzed due to a protocol amendment.|||||
712967|NCT00195663|Secondary|Number of Participants With No Radiographic Progression Over 10 Years|The modified Total Sharp Score (mTSS) is a measure of change in joint health. Digitized images of radiographs of hands and feet obtained at screening and during the study were scored in a blinded manner. Joints were scored for erosions on a scale of 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale of 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement. The number of participants with change from Baseline ≤ 0.5 and ≤ 0 is reported as a measure of no disease progression.|Baseline (prior to first study drug treatment) and Years 2 and 10.|"ITT Analysis Set, with available data. N indicates patients with non-missing radiographic data at each time point."||participants|||Number
713303|NCT00214487|Secondary|Changes in Axial Length at One Year.||One year||||||
713304|NCT00214487|Secondary|Changes in Cycloplegic Subjective Refraction in One Year||One year||||||
712968|NCT00195663|Secondary|Change From Baseline in Modified Total Sharp Score (mTSS) Over 10 Years|The modified TSS (mTSS) is a measure of change in joint health. Digitized images of radiographs of hands and feet obtained at screening and during the study were scored in a blinded manner. Joints were scored for erosions on a scale of 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale of 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.|Baseline (prior to first study drug treatment) and Years 2 and 10|"ITT Analysis Set, with available data. N indicates patients with non-missing radiographic data at each time point."||units on a scale||Standard Deviation|Mean
712969|NCT00195663|Secondary|Number of Participants With DAS28 < 2.6 and < 3.2 Over 10 Years by Adalimumab Exposure|"The DAS28 is a composite score of rheumatoid arthritis disease activity derived from the following variables:
28 tender joint counts,
28 swollen joint counts,
C-reactive protein, and
Patient's global assessment of disease activity.
Scores on the DAS28 range from 0 to 10. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission."|After 1, 2, 5, and 10 years of adalimumab exposure|"ITT Analysis Set, with available data. The Number of Participants Analyzed indicates patients with non-missing DAS28 scores at any post-baseline time point; N indicates patients with non-missing data at each specified time point."||participants|||Number
712970|NCT00195663|Secondary|Change From Baseline in DAS28 Over 10 Years by Adalimumab Exposure|"The DAS28 is a composite score of rheumatoid arthritis disease activity derived from the following variables:
28 tender joint counts,
28 swollen joint counts,
C-reactive protein, and
Patient's global assessment of disease activity.
Scores on the DAS28 range from 0 to 10. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission."|Baseline and Years 1, 2, 5, and 10. Baseline was the last value prior to the first dose of adalimumab. For patients randomized to the MTX arm in the DB phase, Baseline was the last visit prior to the first adalimumab dose at Week 106.|"ITT Analysis Set, with available data. N indicates patients with non-missing data at Baseline and the specified time point."||units on a scale||Standard Deviation|Mean
712971|NCT00195663|Secondary|Change From Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) Over 10 Years by Adalimumab Exposure|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement.|Baseline and Years 1, 2, 5, and 10. Baseline was the last value prior to the first dose of adalimumab. For patients randomized to the MTX arm in the DB phase, Baseline was the last visit prior to the first adalimumab dose at Week 106.|"ITT Analysis Set, with available data. N indicates patients with non-missing data at each time point."||units on a scale||Standard Deviation|Mean
712972|NCT00195663|Secondary|Number of Participants Meeting ACR70 Response Criteria Over 10 Years by Adalimumab Exposure|"American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:
≥ 70% improvement in tender joint count;
≥ 70% improvement in swollen joint count; and
≥ 70% improvement in at least 3 of the 5 following parameters:
Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
Patient's global assessment of disease activity (measured on a 100 mm VAS);
Physician's global assessment of disease activity (measured on a 100 mm VAS);
Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);
Acute phase reactant value (C-Reactive Protein).
Baseline is the last value prior to the first dose of adalimumab. For patients randomized to the methotrexate (MTX) arm in the double-blind (DB) phase, Baseline was the last visit prior to the first adalimumab dose at Week 106 of the open-label (OL) phase."|Baseline and after 1, 2, 5, and 10 years of adalimumab exposure. Baseline was the last value prior to the first dose of adalimumab.|"ITT Analysis Set with available data. N indicates patients with non-missing data at each time point."||participants|||Number
712973|NCT00195663|Secondary|Number of Participants Meeting ACR50 Response Criteria Over 10 Years by Adalimumab Exposure|"American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:
≥ 50% improvement in tender joint count;
≥ 50% improvement in swollen joint count; and
≥ 50% improvement in at least 3 of the 5 following parameters:
Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
Patient's global assessment of disease activity (measured on a 100 mm VAS);
Physician's global assessment of disease activity (measured on a 100 mm VAS);
Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);
Acute phase reactant value (C-Reactive Protein).
Baseline is the last value prior to the first dose of adalimumab. For patients randomized to the methotrexate (MTX) arm in the double-blind (DB) phase, Baseline was the last visit prior to the first adalimumab dose at Week 106 of the open-label (OL) phase."|Baseline and after 1, 2, 5, and 10 years of adalimumab exposure. Baseline was the last value prior to the first dose of adalimumab.|"ITT Analysis Set with available ACR data. N indicates patients with non-missing data at each time point."||participants|||Number
712981|NCT00195663|Secondary|Numeric American College of Rheumatology (ACR-N) During the Double-blind Treatment Phase|ACR-N is a composite, continuous variable which measures the percentage of improvement from Baseline in individual participants based on the 7 core set variables of the ACR. ACR-N is defined as the smallest percent change from Baseline of 3 measures: tender joint counts (TJC), swollen joint counts (SJC), and the median percent improvement in the 5 remaining measures (Patient's Assessment of Pain, Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, Health Assessment Questionnaire - Disability Index [HAQ-DI], and C-Reactive Protein). A positive ACR-N value indicates improvement; a negative ACR-N value indicates worsening; ACR-N of 0 indicates no change.|Baseline and Weeks 26, 52, 76, and 104|Full analysis set with available data.||percent change||Standard Deviation|Mean
713305|NCT00214487|Secondary|Relationship Between Residual Fixation Disparity and Myopia Progression.||One year||||||
712974|NCT00195663|Secondary|Number of Participants Meeting ACR20 Response Criteria Over 10 Years by Adalimumab Exposure|"American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:
≥ 20% improvement in tender joint count;
≥ 20% improvement in swollen joint count; and
≥ 20% improvement in at least 3 of the 5 following parameters:
Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
Patient's global assessment of disease activity (measured on a 100 mm VAS);
Physician's global assessment of disease activity (measured on a 100 mm VAS);
Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);
Acute phase reactant value (C-Reactive Protein).
Baseline is the last value prior to the first dose of adalimumab. For participants randomized to the methotrexate (MTX) arm in the double-blind (DB) phase, Baseline was the last visit prior to the first adalimumab dose at Week 106 of the open-label (OL) phase."|Baseline and after 1, 2, 5, and 10 years of adalimumab exposure. Baseline was the last value prior to the first dose of adalimumab.|"Intent-to-treat (ITT) Analysis Set (all patients who received at least 1 dose of adalimumab during the study, including patients who received their first dose during the DB phase and those who received MTX during the DB phase and adalimumab in the OL phase) with available ACR data. N indicates patients with non-missing data at each time point."||participants|||Number
712975|NCT00195663|Secondary|Number of Participants With Non-Involved Joints at Baseline and No Newly Involved Joints at Weeks 52 and 104|"Number of participants with non-involved joints at Baseline and no newly involved joints at Weeks 52 and 104, where involved joints or no newly involved joints are defined as modified Total Sharp Score (mTSS) = 0.
Digitized images of radiographs of hands and feet obtained at screening and during the study were scored in a blinded manner. Joints were scored for erosions on a scale of 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale of 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease])."|Baseline and Weeks 52 and 104|Full analysis set participants with non-involved joints at Baseline and non-missing data.||participants|||Number
712976|NCT00195663|Secondary|Number of Participants With No Erosions at Baseline and No New Erosions at Weeks 52 and 104|"The number of participants with no erosions at Baseline and no erosions at Weeks 52 and 104, where no erosions and no new erosions are defined as an erosion score = 0.
Digitized images of radiographs of hands and feet obtained at screening and during the study were scored in a blinded manner. Joints on each hand/wrist (17 joints) and each forefoot (6 joints) were scored for erosions on a scale of 0 = no erosions; 1 = 1 discrete erosion or ≤20% joint involvement; 2 = 2 separate quadrants with erosion or 21–40% joint involvement; 3 = 3 separate quadrants with erosion or 41–60% joint involvement; 4 = all 4 quadrants with erosion or 61–80% joint involvement; and 5 = extensive destruction with >80% joint involvement. Scores were summed to calculate the total erosion score, which ranges from 0 (no erosion) to 230 (worst)."|Baseline and Weeks 52 and 104|Full analysis set participants with no erosions at Baseline and non-missing data.||participants|||Number
712977|NCT00195663|Secondary|Number of Participants With No Worsening in Modified Total Sharp Score or Components During the Double-blind Treatment Phase|"The number of participants with no worsening in the modified Total Sharp Score (mTSS) and in erosion and joint space narrowing (JSN) scores, where no worsening is defined as a change from Baseline of ≤ 0 in mTSS, erosion score and JSN score, at Weeks 52 and 104.
Digitized images of radiographs of hands and feet obtained at screening and during the study were scored in a blinded manner. Joints were scored for erosions on a scale of 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale of 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement."|Baseline and Weeks 52 and 104|Full analysis set. Participants with missing data or who withdrew early were considered non-responders.||participants|||Number
712978|NCT00195663|Secondary|Change From Baseline in Joint Space Narrowing Score During the Double-blind Treatment Period|Digitized images of radiographs of hands and feet obtained at screening and during the study were scored in a blinded manner. Joint space narrowing (JSN) scores were recorded for each hand/wrist (16 joints) and each forefoot (5 joints) on a 5-point scale (0 = no narrowing; 1 = up to 25% narrowing; 2 = 26–65% narrowing; 3 = 66–99% narrowing; and 4 = complete narrowing). Scores were summed to calculate the total score ranging from 0 (no narrowing) to 168 (maximum narrowing). A large increase in joint narrowing score is indicative of worsening, whereas a small change or no change is indicative of inhibition of JSN.|Baseline and Weeks 52 and 104|Full analysis set. Missing values were imputed.||units on a scale||Standard Deviation|Mean
712979|NCT00195663|Secondary|Change From Baseline in Joint Erosion Score During the Double-blind Treatment Period|Digitized images of radiographs of hands and feet obtained at screening and during the study were scored in a blinded manner. Joints on each hand/wrist (17 joints) and each forefoot (6 joints) were scored for erosions on a scale of 0 = no erosions; 1 = 1 discrete erosion or ≤20% joint involvement; 2 = 2 separate quadrants with erosion or 21–40% joint involvement; 3 = 3 separate quadrants with erosion or 41–60% joint involvement; 4 = all 4 quadrants with erosion or 61–80% joint involvement; and 5 = extensive destruction with >80% joint involvement. Scores were summed to calculate the total erosion score, which ranges from 0 (no erosion)to 230 (worst). A large increase in erosion score is indicative of worsening, whereas a small change or no change is indicative of inhibition of joint erosion.|Baseline and Weeks 52 and 104|Full analysis set. Missing values were imputed.||units on a scale||Standard Deviation|Mean
712980|NCT00195663|Secondary|Change From Baseline in Disease Activity Score (DAS28) During the Double-blind Treatment Phase|"The DAS28 is a composite score of rheumatoid arthritis disease activity derived from the following variables:
28 tender joint counts,
28 swollen joint counts,
C-reactive protein, and
Patient's global assessment of disease activity.
Scores on the DAS28 range from 0 to 10. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission."|Baseline and Weeks 26, 52, 76, and 104|Full analysis set with available data.||units on a scale||Standard Deviation|Mean
713056|NCT00195715|Primary|Percentage of Subjects Achieving Clinical Remission|Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score of < 150. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.|Week 156|Intent-to-treat, defined as all subjects who received at least 1 dose of study drug; Observed Cases||Percentage of participants|||Number
712982|NCT00195663|Secondary|Change From Baseline in the Short Form-36 Health Status Survey (SF-36) During the Double-blind Treatment Phase|The SF-36 determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 comprise the physical component and items 5-8 comprise the mental component of the SF-36. Scores on each item were summed and averaged (range = 0-100); increases from Baseline indicate improvement.|Baseline and Weeks 26 and 104|Full analysis set with available data.||units on a scale||Standard Deviation|Mean
712983|NCT00195663|Secondary|Change From Baseline in Health Utilities Index Mark 2 and Mark 3 (HUI 2/3) During the Double-blind Treatment Phase|"The HUI 2/3 is an assessment of various aspects of participants’ health and ability to perform various tasks on a day-to-day basis, including reading, seeing, hearing, speaking, general outlook on life, pain/discomfort, ability to walk, use of hands, memory, ability to think/solve, and ability to perform basic activities such as eating, bathing, and dressing. The HUI 2/3 is a combined 15-item questionnaire based on a recall period of the previous 4 weeks. HUI-2 and HUI-3 scores are calculated independently. The HUI-2 score includes 6 attributes: Sensation, Mobility, Emotion, Cognition, Self-Care, and Pain. The HUI-3 score is comprised of 8 attributes: Vision, Hearing, Speech, Ambulation, Dexterity, Emotion, Cognition, and Pain.
The range of each score is from 0 (dead) to 1 (perfect health). An increase from Baseline indicates improvement."|Baseline and Weeks 26, 52, and 104|Full analysis set with available data.||units on a scale||Standard Deviation|Mean
712984|NCT00195663|Secondary|Number of Participants With Improvement in the HAQ-DI Score ≥ 0.3 During the Double-blind Treatment Phase|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability.|Baseline and Weeks 26, 52, 76, and 104|Full analysis set. Missing values were considered to be < 0.3.||participants|||Number
712985|NCT00195663|Secondary|Change From Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) During the Double-blind Treatment Phase|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement.|Baseline and Weeks 12, 26, 76, and 104|Full analysis set with available data.||units on a scale||Standard Deviation|Mean
712986|NCT00195663|Secondary|Number of Participants Meeting American College of Rheumatology 70% (ACR70) Response Criteria During the Double-blind Phase|"American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:
≥ 70% improvement in tender joint count;
≥ 70% improvement in swollen joint count; and
≥ 70% improvement in at least 3 of the 5 following parameters:
Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
Patient's global assessment of disease activity (measured on a 100 mm VAS);
Physician's global assessment of disease activity (measured on a 100 mm VAS);
Patient's self-assessment of physical function (Health Assessment Questionnaire Disability Index [HAQ-DI]);
Acute phase reactant value (C-Reactive Protein).
Participants withdrawing early were considered non-responders."|Baseline and Weeks 26, 52, 76, and 104|Full analysis set. Participants with insufficient data to calculate ACR70 or who withdrew early were considered non-responders.||participants|||Number
712987|NCT00195663|Secondary|Number of Participants Meeting American College of Rheumatology 20% (ACR20) Response Criteria During the Double-blind Phase|"American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:
≥ 20% improvement in tender joint count;
≥ 20% improvement in swollen joint count; and
≥ 20% improvement in at least 3 of the 5 following parameters:
Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
Patient's global assessment of disease activity (measured on a 100 mm VAS);
Physician's global assessment of disease activity (measured on a 100 mm VAS);
Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);
Acute phase reactant value (C-Reactive Protein).
Participants withdrawing early were considered non-responders."|Baseline and Weeks 26, 52, 76, and 104|Full analysis set. Participants with insufficient data to calculate ACR20 or who withdrew early were considered non-responders.||participants|||Number
712988|NCT00195663|Secondary|Number of Participants Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Weeks 26 and 76|"American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:
≥ 50% improvement in tender joint count;
≥ 50% improvement in swollen joint count; and
≥ 50% improvement in at least 3 of the 5 following parameters:
Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
Patient's global assessment of disease activity (measured on a 100 mm VAS);
Physician's global assessment of disease activity (measured on a 100 mm VAS);
Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);
Acute phase reactant value (C-Reactive Protein).
Participants withdrawing early were considered non-responders."|Baseline and Weeks 26 and 76|Full analysis set. Participants with insufficient data to calculate ACR50 or who withdrew early were considered non-responders.||participants|||Number
713051|NCT00195715|Secondary|Percentage of Subjects Achieving Steroid-free CR-100|Steroid-free CR-100 was achieved if the subject stopped taking steroids before the visit and had a decrease from baseline in CDAI score of 100 or more points at that visit. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.|Week 156|Intent-to-treat, Subjects with corticosteroid use at baseline of preceding study, Observed Cases||Percentage of participants|||Number
712989|NCT00195663|Secondary|Change From Baseline in the Mental Component of the Short Form-36 Health Status Survey (SF-36) at Week 52|The SF-36 determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 5-8 comprise the mental component of the SF-36. Scores on each item were summed and averaged (range = 0-100); increases from Baseline indicate improvement.|Baseline and Week 52|Full analysis set with available data.||units on a scale||Standard Deviation|Mean
712990|NCT00195663|Secondary|Number of Participants With Major Clinical Response After 104 Weeks of Treatment|"Major clinical response was defined as an American College of Rheumatology 70% (ACR70) response for any six continuous months, over 104 weeks of treatment. A participant was a responder if the following criteria for improvement from Baseline were met:
≥ 70% improvement in tender joint count;
≥ 70% improvement in swollen joint count; and
≥ 70% improvement in at least 3 of the 5 following parameters:
Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
Patient's global assessment of disease activity (measured on a 100 mm VAS);
Physician's global assessment of disease activity (measured on a 100 mm VAS);
Patient’s self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);
Acute phase reactant value (C-Reactive Protein).
Participants withdrawing early were non-responders."|Any 6 continuous months from Baseline to Week 104|Full analysis set.||participants|||Number
712991|NCT00195663|Secondary|Change From Baseline in the Physical Component of the Short Form-36 Health Status Survey (SF-36) at Week 52|The SF-36 determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 comprise the physical component of the SF-36. Scores on each item were summed and averaged (range = 0-100); increases from Baseline indicate improvement.|Baseline and Week 52|Full analysis set with available data.||units on a scale||Standard Deviation|Mean
712992|NCT00195663|Secondary|Number of Participants Who Achieved Clinical Remission, Defined as a Disease Activity 28 (DAS28) Score < 2.6 at Week 52|The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C reactive protein, and general health were included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.|Week 52|Full analysis set. Participants with insufficient data to calculate DAS28 at Week 52 or who withdrew early were considered non-responders.||participants|||Number
712993|NCT00195663|Secondary|Change From Baseline in Modified Total Sharp Score (mTSS) at Week 104|The modified Total Sharp Score (mTSS) is a measure of change in joint health. Digitized images of radiographs of hands and feet obtained at screening and Week 104 were scored in a blinded manner. Joints were scored for erosions on a scale of 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale of 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.|Baseline and Week 104|Full analysis set. For participants with missing data, mTSS was imputed by linear extrapolation.||units on a scale||Standard Deviation|Mean
712994|NCT00195663|Secondary|Number of Participants Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 104|"American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:
≥ 50% improvement in tender joint count;
≥ 50% improvement in swollen joint count; and
≥ 50% improvement in at least 3 of the 5 following parameters:
Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
Patient's global assessment of disease activity (measured on a 100 mm VAS);
Physician's global assessment of disease activity (measured on a 100 mm VAS);
Patient’s self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);
Acute phase reactant value (C-Reactive Protein).
Participants withdrawing early were considered non-responders."|Baseline and Week 104|Full analysis set. Participants with insufficient data to calculate ACR50 at Week 104 or who withdrew early were considered non-responders.||participants|||Number
712995|NCT00195663|Secondary|Change From Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 52|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement.|Baseline and Week 52|Full analysis set with available data.||units on a scale||Standard Deviation|Mean
712996|NCT00195663|Primary|Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52|The modified Total Sharp Score (mTSS) is a measure of change in joint health. Digitized images of radiographs of hands and feet obtained at screening and Week 52 were scored in a blinded manner. Joints were scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.|Baseline and Week 52|Full analysis set. For participants with missing data, mTSS was imputed by linear extrapolation.||units on a scale||Standard Deviation|Mean
713057|NCT00195715|Secondary|Percentage of Subjects Achieving Clinical Remission|Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score of < 150. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.|Week 108|Intent-to-treat, Observed Cases||Percentage of participants|||Number
712997|NCT00195663|Primary|Number of Participants Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 52|"American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:
≥ 50% improvement in tender joint count;
≥ 50% improvement in swollen joint count; and
≥ 50% improvement in at least 3 of the 5 following parameters:
Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
Patient's global assessment of disease activity (measured on a 100 mm VAS);
Physician's global assessment of disease activity (measured on a 100 mm VAS);
Patient’s self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));
Acute phase reactant value (C-Reactive Protein).
Participants who withdrew early were considered non-responders."|Baseline and 52 Weeks|The Full Analysis Set consisted of all patients who were randomized and who received at least one dose of double-blinded study medication. Participants with insufficient data to calculate ACR50 at Week 52 or who withdrew early were considered non-responders.||participants|||Number
712998|NCT00195676|Other Pre-specified|Percentage of Period R Modified Intent-to-Treat Participants Who Did Not Relapse in Period W and Subsequently Had a Physician's Global Assessment of Clear or Minimal at Week 16 of Period R|The Physician's Global Assessment [PGA] was scored by the physician using a 6-point scale (0-5) for the degree of overall lesion severity, where 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, and 5 = very severe. Subjects with a PGA of Clear or Minimal overall lesion severity had scores of 0 or 1.|Week 16 of Period R|Participants in the Period R mITT population who did not relapse (did not have a PGA greater than or equal to 3) with adalimumab treatment withdrawal during Period W. Results were analyzed using non-responder imputation (NRI) for missing values.||percentage of participants|||Number
712999|NCT00195676|Other Pre-specified|Percentage of Period R Modified Intent-to-Treat Participants Who Relapsed in Period W and Subsequently Had a Physician's Global Assessment of Clear or Minimal at Week 16 of Period R|The Physician's Global Assessment [PGA] was scored by the physician using a 6-point scale (0-5) for the degree of overall lesion severity, where 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, and 5 = very severe. Subjects with a PGA of Clear or Minimal overall lesion severity had scores of 0 or 1.|Week 16 of Period R|Participants in the Period R mITT population who had relapsed (had a PGA of greater than or equal to 3) with adalimumab treatment withdrawal during Period W. Results were analyzed using non-responder imputation (NRI) for missing values.||percentage of participants|||Number
713000|NCT00195676|Other Pre-specified|Time to Relapse in Period W|Relapse of psoriasis was defined as a Physician's Global Assessment (assessment of overall lesion severity) score of greater than or equal to 3 (3=moderate; 4=severe; 5=very severe).|Period W|Participants in the Period W Modified Intent-to-Treat Population who had relapsed (defined by a PGA of greater than or equal to 3) during Period W and had at least one post-baseline PGA assessment in Period W.||days||95% Confidence Interval|Median
713001|NCT00195676|Other Pre-specified|Percentage of Participants Who Achieved a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 120|Psoriasis Area and Severity Index (PASI) scores were calculated from assessments at 4 designated anatomical sites (head, upper extremities, trunk, lower extremities) using both severity and area subscores (i.e., degree of and amount of psoriatic involvement per site). PASI scores range from 0.0 (best) to 72.0 (worst), with the highest score representing complete erythroderma of the severest degree. Positive percent decreases indicate improvement, with the best improvement being 100%. A PASI 75 response was at least a 75% reduction in PASI score from baseline PASI score of the initial study.|Week 120|A subset of the the All Adalimumab Treatment population who initiated treatment with an adalimumab 40 mg every other week (eow) injection or placebo injection in a prior study. Results were analyzed using Last Observation Carried Forward (LOCF) imputation for missing values.||percentage of participants|||Number
713002|NCT00195676|Other Pre-specified|Percentage of Participants Who Achieved a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 60|Psoriasis Area and Severity Index (PASI) scores were calculated from assessments at 4 designated anatomical sites (head, upper extremities, trunk, lower extremities) using both severity and area subscores (i.e., degree of and amount of psoriatic involvement per site). PASI scores range from 0.0 (best) to 72.0 (worst), with the highest score representing complete erythroderma of the severest degree. Positive percent decreases indicate improvement, with the best improvement being 100%. A PASI 75 response was at least a 75% reduction in PASI score from baseline PASI score of the initial study.|Week 60|A subset of the All Adalimumab Treatment population who initiated treatment with an adalimumab 40 mg every other week (eow) injection or placebo injection in a prior study. Results were analyzed using Last Observation Carried Forward (LOCF) imputation for missing values.||percentage of participants|||Number
713003|NCT00195676|Primary|Percentage of Participants With a Physician's Global Assessment of Clear or Minimal at Week 16 of Period R|The Physician's Global Assessment [PGA] was scored by the physician using a 6-point scale (0-5) for the degree of overall lesion severity, where 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, and 5 = very severe. Subjects with a PGA of Clear or Minimal overall lesion severity had scores of 0 or 1.|Week 16 of Period R|The Period R Modified Intent-to-Treat population included 178 participants who relapsed and 107 participants who did not relapse in Period W when therapy was withdrawn; all received Period R adalimumab 40 mg every other week (after an 80 mg initial dose). Results were analyzed using non-responder imputation (NRI) for missing values.||percentage of participants|||Number
713004|NCT00195676|Other Pre-specified|Percentage of Participants With a Physician's Global Assessment of Clear or Minimal at Week 120|The Physician's Global Assessment [PGA] was scored by the physician using a 6-point scale (0-5) for the degree of overall lesion severity, where 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, and 5 = very severe. Subjects with a PGA of Clear or Minimal overall lesion severity had scores of 0 or 1.|Week 120|A subset of the All Adalimumab Treatment population who initiated treatment with an adalimumab 40 mg every other week (eow) injection or placebo injection in a prior study. Results were analyzed using Last Observation Carried Forward (LOCF) imputation for missing values.||percentage of participants|||Number
713052|NCT00195715|Secondary|Percentage of Subjects Achieving Steroid-free Clinical Remission|Steroid-free remission was achieved if the subject stopped taking steroids before the visit and had a Crohn's Disease Activity Index (CDAI) score of <150. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.|Week 156|Intent-to-treat, Subjects with steroid use at baseline of preceding study, Observed Cases||Percentage of participants|||Number
713306|NCT00214487|Secondary|Changes in Manifest Refraction at One Year.||One year||||||
713005|NCT00195676|Other Pre-specified|Percentage of Participants With a Physician's Global Assessment of Clear or Minimal at Week 60|The Physician's Global Assessment [PGA] was scored by the physician using a 6-point scale (0-5) for the degree of overall lesion severity, where 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, and 5 = very severe. Subjects with a PGA of Clear or Minimal overall lesion severity had scores of 0 or 1.|Week 60|A subset of the All Adalimumab Treatment population who initiated treatment with an adalimumab 40 mg every other week (eow) injection or placebo injection in a prior study. Results were analyzed using Last Observation Carried Forward (LOCF) imputation for missing values.||percentage of participants|||Number
713006|NCT00195702|Other Pre-specified|Change From Baseline in Modified Total Sharp X-ray Score at Week 520|Modified total Sharp x-ray score (mTSS) is a measure of change in joint health. Radiographs of hands/wrists and feet were obtained at screening and Week 520. Digitized images of these were scored in a blinded manner. Joints were scored for erosions from 0 (no damage) to 5 and for joint space narrowing from 0 (no damage) to 4; scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). Large positive change indicates disease progression; small positive/no change indicates slowing/halting of disease progression; and negative change may indicate improvement of disease.|Baseline and Week 520|Participants in each of the three groups were randomized subjects with non-missing radiographs who remained in the study. Baseline was defined as the value at the first visit. Analyses were performed using data as observed (no imputation).||units on a scale||Standard Deviation|Mean
713007|NCT00195702|Other Pre-specified|Change From Baseline in Modified Total Sharp X-ray Score at Week 416|Modified total Sharp x-ray score (mTSS) is a measure of change in joint health. Radiographs of hands/wrists and feet were obtained at screening and Week 416. Digitized images of these were scored in a blinded manner. Joints were scored for erosions from 0 (no damage) to 5 and for joint space narrowing from 0 (no damage) to 4; scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). Large positive change indicates disease progression; small positive/no change indicates slowing/halting of disease progression; and negative change may indicate improvement of disease.|Baseline and Week 416|Participants in each of the three groups were randomized subjects with non-missing radiographs who remained in the study. Baseline was defined as the value at the first visit. Analyses were performed using data as observed (no imputation).||units on a scale||Standard Deviation|Mean
713008|NCT00195702|Other Pre-specified|Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 520|Subjects assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3)eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Subjects assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores were: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Negative mean changes from Baseline in the disability index of the HAQ indicated improvement.|Baseline and Week 520|Participants analyzed were intent-to-treat subjects with non-missing change who remained in the study. Baseline was the last non-missing value prior to the first injection of adalimumab. Analyses were performed using data as observed (no imputation).||units on a scale||Standard Deviation|Mean
713009|NCT00195702|Other Pre-specified|Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 260|Subjects assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3)eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Subjects assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores were: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Negative mean changes from Baseline in the disability index of the HAQ indicated improvement.|Baseline and Week 260|Participants analyzed were intent-to-treat subjects with non-missing change who remained in the study. Baseline was the last non-missing value prior to the first injection of adalimumab. Analyses were performed using data as observed (no imputation).||units on a scale||Standard Deviation|Mean
713010|NCT00195702|Other Pre-specified|Number of Participants With at Least a 0.22 Reduction From Baseline in the Health Assessment Questionnaire (HAQ) Disability Index at Week 520|The Health Assessment Questionnaire (HAQ) Disability Index is a self-reported measure of disability, which assesses the patient's ability to perform the following tasks: dress and groom; arise; eat; walk; reach; grip; maintain hygiene; and maintain daily activity. Possible responses/scores are 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do). Negative mean changes from Baseline indicate improvement. An improvement of 0.22 in score (a -0.22 or greater reduction from Baseline score) is a minimally clinically significant change.|Week 520|Participants analyzed were intent-to-treat subjects with non-missing response who remained in the study. Baseline was the last non-missing value prior to the first injection of adalimumab. Analyses were performed using data as observed (no imputation).||participants|||Number
713011|NCT00195702|Other Pre-specified|Number of Participants With at Least a 0.22 Reduction From Baseline in the Health Assessment Questionnaire (HAQ) Disability Index at Week 260|The Health Assessment Questionnaire (HAQ) Disability Index is a self-reported measure of disability, which assesses the patient's ability to perform the following tasks: dress and groom; arise; eat; walk; reach; grip; maintain hygiene; and maintain daily activity. Possible responses/scores are 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do). Negative mean changes from Baseline indicate improvement. An improvement of 0.22 in score (a -0.22 or greater reduction from Baseline score) is a minimally clinically significant change.|Week 260|Participants analyzed were intent-to-treat with non-missing response who remained in the study. Baseline was the last non-missing value prior to the first injection of adalimumab. Analyses were performed using data as observed (no imputation).||participants|||Number
713012|NCT00195702|Other Pre-specified|Number of Participants With a Continuous American College of Rheumatology 70% (ACR70) Response for at Least 6 Months Through Year 10|Patients were responders if they had: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant: C-reactive protein.|Baseline through Week 520|Participants analyzed were intent-to-treat subjects with non-missing response. Analyses were performed using data as observed (no imputation).||participants|||Number
713307|NCT00214487|Secondary|Keratometric Changes at One Year.||One year||||||
713013|NCT00195702|Other Pre-specified|Number of Participants Meeting the American College of Rheumatology 70% (ACR70) Response Criteria at Week 520|Patients were responders if they had: >= 70% improvement in tender joint count; >= 70% improvement in swollen joint count; and >= 70% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant: C-reactive protein.|Week 520|Participants analyzed were intent-to-treat subjects with non-missing response who remained in the study. All analyses were performed using data as observed (no imputation).||participants|||Number
713014|NCT00195702|Other Pre-specified|Number of Participants Meeting the American College of Rheumatology 70% (ACR70) Response Criteria at Week 260|Patients were responders if they had: >= 70% improvement in tender joint count; >= 70% improvement in swollen joint count; and >= 70% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant: C-reactive protein.|Week 260|Participants analyzed were intent-to-treat subjects with non-missing response who remained in the study. All analyses were performed using data as observed (no imputation).||participants|||Number
713015|NCT00195702|Other Pre-specified|Number of Participants Meeting the American College of Rheumatology 50% (ACR50) Response Criteria at Week 520|Patients were responders if they had: >= 50% improvement in tender joint count; >= 50% improvement in swollen joint count; and >= 50% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant: C-reactive protein.|Week 520|Participants analyzed were intent-to-treat subjects with non-missing response who remained in the study. All analyses were performed using data as observed (no imputation).||participants|||Number
713016|NCT00195702|Other Pre-specified|Number of Participants Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 260|Patients were responders if they had: >= 50% improvement in tender joint count; >= 50% improvement in swollen joint count; and >= 50% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant: C-reactive protein.|Week 260|Participants analyzed were intent-to-treat subjects with non-missing response who remained in the study. All analyses were performed using data as observed (no imputation).||participants|||Number
713017|NCT00195702|Other Pre-specified|Number of Participants Meeting the American College of Rheumatology 20% (ACR20) Response Criteria at Week 520|Patients were responders if they had: >= 20% improvement in tender joint count; >= 20% improvement in swollen joint count; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant: C-reactive protein.|Week 520|Participants analyzed were intent-to-treat subjects with non-missing response who remained in the study. All analyses were performed using data as observed (without imputation).||participants|||Number
713018|NCT00195702|Other Pre-specified|Number of Participants Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 260|Patients were responders if they had: >= 20% improvement in tender joint count; >= 20% improvement in swollen joint count; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant: C-reactive protein.|Week 260|Participants analyzed were intent-to-treat subjects with non-missing response who remained in the study. All analyses were performed as observed (without imputation).||Participants|||Number
713019|NCT00195702|Other Pre-specified|Baseline Measure: Age Categories for the Any Adalimumab Through Year 10 Group (Intent-to-Treat)|Age recorded at Baseline, reported by category, for the Intent-to-Treat population (the Any Adalimumab Through Year 10 group) of the study. This measure was not included in the Baseline Characteristics section due to the difficulty of maintaining correct subject numbers and totals in that section.|Baseline for Intent-to-Treat (Any Adalimumab Through Year 10) Group|Participants in the Any Adalimumab Through Year 10 group are intent-to-treat subjects.||participants|||Number
713020|NCT00195702|Other Pre-specified|Baseline Measure: Gender - Female/Male - for the Any Adalimumab Through Year 10 Group (Intent-to-Treat)|Gender (female/male) recorded at Baseline for the Intent-to-Treat population (the Any Adalimumab Through Year 10 group) of the study. This measure was not included in the Baseline Characteristics section due to the difficulty of maintaining correct subject numbers and totals in that section.|Baseline for Intent-to-Treat (Any Adalimumab Through Year 10) Group|Participants in the Any Adalimumab Through Year 10 group are intent-to-treat subjects.||participants|||Number
713021|NCT00195702|Secondary|Estimated Yearly Progression of Rheumatoid Arthritis|Estimated yearly progression was defined as modified total Sharp x-ray score at baseline divided by duration of rheumatoid arthritis disease at baseline. Actual progression during the study was defined as modified total Sharp x-ray score at Week 52 minus modified total Sharp x-ray score at baseline divided by the duration of the study. The range of scores for the modified total Sharp x-ray score was 0 (normal) to 398 (maximal disease).|Baseline and Week 52|Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Missing values were imputed via linear extrapolation from baseline.||Units on a scale||Standard Deviation|Mean
713029|NCT00195702|Secondary|Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 24|Subjects assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Subjects assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores included the following: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Negative mean changes from baseline in the disability index of the HAQ indicated improvement.|Baseline and Week 24|Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. LOCF data analysis was used for missing values.||Units on a scale||Standard Deviation|Mean
713022|NCT00195702|Secondary|Time to First Response According to ACR70 Criteria - Number of Participants Meeting ACR70 Criteria for the First Time at Each Time Point|Patients were responders if they had: >= 70% improvement in tender joint count; >= 70% improvement in swollen joint count; and >= 70% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant: C-reactive protein. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders.|Baseline through Week 52|Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Observed data were analyzed. The number of subjects meeting ACR70 response criteria for the first time at each time point is presented.||Participants|||Number
713023|NCT00195702|Secondary|Time to First Response According to ACR50 Criteria - Number of Participants Meeting ACR50 Criteria for the First Time at Each Time Point|Patients were responders if they had: >= 50% improvement in tender joint count; >= 50% improvement in swollen joint count; and >= 50% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant: C-reactive protein. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders.|Baseline through Week 52|Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Observed data were analyzed. The number of subjects meeting ACR50 response criteria for the first time at each time point is presented.||Participants|||Number
713024|NCT00195702|Secondary|Time to First Response According to ACR20 Criteria - Number of Participants Meeting ACR20 Criteria for the First Time at Each Time Point|Patients were responders if they had: >= 20% improvement in tender joint count; >= 20% improvement in swollen joint count; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant: C-reactive protein. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders.|Baseline through Week 52|Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Observed data were analyzed. The number of subjects meeting ACR20 response criteria for the first time at each time point is presented.||Participants|||Number
713025|NCT00195702|Secondary|Number of Participants With a Continuous ACR70 Response for 6 Months During 52 Weeks of Treatment|Patients were responders if they had: >= 70% improvement in tender joint count; >= 70% improvement in swollen joint count; and >= 70% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant: C-reactive protein. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders.|Baseline through Week 52|Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Observed data were analyzed.||Participants|||Number
713026|NCT00195702|Secondary|Maintenance of ACR20 Response at Week 52 for Participants Who Were ACR20 Responders at Week 24|Patients were responders if they had: >= 20% improvement in tender joint count; >= 20% improvement in swollen joint count; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant: C-reactive protein. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders.|Week 52|Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Subjects who were ACR20 responders at Week 24 were evaluated to determine whether the response was maintained. Observed data were analyzed.||Participants|||Number
713027|NCT00195702|Secondary|Maintenance of the Disability Index of the HAQ at Week 52 for Participants Who Were Responders at Week 12 or Week 24|Subjects assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Subjects assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores included the following: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Responders had a >= 0.22-unit decrease (improvement) in HAQ scores from baseline to Week 12 or 24.|Week 52|Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Subjects who were responders at Week 12 or 24 were evaluated to determine whether the response was maintained. LOCF data analysis was used for missing values.||Participants|||Number
713028|NCT00195702|Primary|Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 52|Subjects assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Subjects assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores included the following: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Negative mean changes from baseline in the disability index of the HAQ indicated improvement.|Baseline and Week 52|Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Last observation carried forward (LOCF) data analysis was used for missing values.||Units on a scale||Standard Deviation|Mean
713050|NCT00195715|Secondary|Percentage of Subjects With Fistula Remission|Fistula remission was defined as the absence of draining fistulas in subjects with fistula present at the preceding study's baseline visit.|Week 156|Intent-to-treat, Subjects with fistulas present at baseline of the preceding study, Observed Cases||Percentage of participants|||Number
713053|NCT00195715|Secondary|Percentage of Subjects Achieving Clinical Response 70 (CR-70)|A CR-70 is a decrease from baseline in CDAI score of 70 or more points. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.|Week 156|Intent-to-treat, Observed Cases||Percentage of participants|||Number
713030|NCT00195702|Secondary|Change From Baseline in Modified Total Sharp X-ray Score at Week 24|Modified total Sharp x-ray score (mTSS) is a measure of change in joint health. Radiographs of hands/wrists and feet were obtained at screening and Week 24. Digitized images of these were scored in a blinded manner. Joints were scored for erosions from 0 (no damage) to 5 and for joint space narrowing from 0 (no damage) to 4; scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). Large positive change indicates disease progression; small positive/no change indicates slowing/halting of disease progression; and negative change may indicate improvement of disease.|Baseline and Week 24|Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Missing values were imputed via linear extrapolation from baseline using data collected at baseline and Week 52.||Units on a scale||Standard Deviation|Mean
713031|NCT00195702|Secondary|Number of Participants Meeting ACR20 Response Criteria at Week 52|Patients were responders if they had: >= 20% improvement in tender joint count; >= 20% improvement in swollen joint count; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant: C-reactive protein. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders.|Week 52|Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Observed data were analyzed.||Participants|||Number
713032|NCT00195702|Primary|Change From Baseline in Modified Total Sharp X-ray Score at Week 52|Modified total Sharp x-ray score (mTSS) is a measure of change in joint health. Radiographs of hands/wrists and feet were obtained at screening and Week 52. Digitized images of these were scored in a blinded manner. Joints were scored for erosions from 0 (no damage) to 5 and for joint space narrowing from 0 (no damage) to 4; scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). Large positive change indicates disease progression; small positive/no change indicates slowing/halting of disease progression; and negative change may indicate improvement of disease.|Baseline and Week 52|Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Missing values were imputed via linear extrapolation from baseline using data collected at baseline and Week 24 or early termination.||Units on a scale||Standard Deviation|Mean
713033|NCT00195702|Primary|Number of Participants Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 24|Patients were responders if they had: >= 20% improvement in tender joint count; >= 20% improvement in swollen joint count; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant: C-reactive protein. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders.|Week 24|Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Observed data were analyzed.||Participants|||Number
713034|NCT00195715|Secondary|Percentage of Subjects With Fatal Adverse Event||Up to 262 weeks of adalimumab treatment|Safety population||Percentage of participants|||Number
713035|NCT00195715|Secondary|Percentage of Subjects With Hematologic-related Adverse Event||Up to 262 weeks of adalimumab treatment|Safety population||Percentage of participants|||Number
713036|NCT00195715|Secondary|Percentage of Subjects With Lupus-like Syndrome||Up to 262 weeks of adalimumab treatment|Safety population||Percentage of participants|||Number
713037|NCT00195715|Secondary|Percentage of Subjects With Allergic Reaction-related Adverse Event||Up to 262 weeks of adalimumab treatment|Safety population||Percentage of participants|||Number
713038|NCT00195715|Secondary|Percentage of Subjects With Hepatic-related Adverse Event||Up to 262 weeks of adalimumab treatment|Safety population||Percentage of participants|||Number
713039|NCT00195715|Secondary|Percentage of Subjects With Demyelinating Disease||Up to 262 weeks of adalimumab treatment|Safety population||Percentage of participants|||Number
713040|NCT00195715|Secondary|Percentage of Subjects With Congestive Heart Failure||Up to 262 weeks of adalimumab treatment|Safety population||Percentage of subjects|||Number
713041|NCT00195715|Secondary|Percentage of Subjects With Opportunistic Infection (Excluding Tuberculosis)||Up to 262 weeks of adalimumab treatment|Safety population||Percentage of participants|||Number
713042|NCT00195715|Secondary|Percentage of Subjects With Injection Site Reaction-related Adverse Event|"An injection site reaction is any adverse event corresponding to a preferred term beginning with injection site excluding injection site arthritis, injection site movement impairment, injection site photosensitivity, injection site joint effusion, injection site joint inflammation, injection site scab, injection site joint pain, or injection site laceration."|Up to 262 weeks of adalimumab treatment|Safety population||Percentage of participants|||Number
713043|NCT00195715|Secondary|Percentage of Subjects With Malignancy (Including Lymphoma, Excluding Nonmelanoma Skin Cancer)||Up to 262 weeks of adalimumab treatment|Safety population||Percentage of participants|||Number
713044|NCT00195715|Secondary|Percentage of Subjects With Malignancy (Excluding Nonmelanoma Skin Cancer and Lymphoma)||Up to 262 weeks of adalimumab treatment|Safety population||Percentage of participants|||Number
713045|NCT00195715|Secondary|Percentage of Subjects With Nonmelanoma Skin Cancer||Up to 262 weeks of adalimumab treatment|Safety population||Percentage of participants|||Number
713046|NCT00195715|Secondary|Percentage of Subjects With Lymphoma||Up to 262 weeks of adalimumab treatment|Safety population||Percentage of participants|||Number
713047|NCT00195715|Secondary|Percentage of Subjects With Malignancy||Up to 262 weeks of adalimumab treatment|Safety population||Percentage of participants|||Number
713048|NCT00195715|Secondary|Percentage of Subjects With Serious Infection|Serious infections are infectious adverse events that meet at least one criterion for a serious adverse event (e.g., death, life threatening event, hospitalization) including tuberculosis (TB), bacterial sepsis, invasive fungal infections (e.g., histoplasmosis), and infections due to other opportunistic pathogens.|Up to 262 weeks of adalimumab treatment|Safety population||Percentage of participants|||Number
713049|NCT00195715|Secondary|Percentage of Subjects With Infection||Up to 262 weeks of adalimumab treatment|Safety population, defined as all subjects who received at least 1 dose of study drug||Percentage of participants|||Number
713059|NCT00195819|Primary|Mean Change in the Modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) Compared Against a Historical Control Group (Outcomes in Ankylosing Spondylitis International Study [OASIS]) Using the ANCOVA Model Adjusting for Baseline mSASSS Score|Radiographic progression was based on change in mSASSS scoring (comparison of the means) from double-blind Baseline visit to Week 104. The mSASSS is the sum of the lumbar and cervical spine score ( 0 [no change] to 72 [progression]), derived from scoring the anterior site of the lumbar spine (T12 to S1) and the cervical spine (C2 to T1) as either 0 (normal), 1 (erosion, sclerosis, or squaring), 2 (syndesmophyte), 3 (bridging syndesmophyte), or N (vertebral body not evaluable). Data from NCT00195819 was compared with data from AS patients in OASIS.|Baseline and Week 104|The OASIS cohort is a historical control group of Dutch, French, and Belgian patients with AS who have been followed up since 1996. These patients participated in a follow-up study on the natural course of AS with conventional (non-biologic) treatment.||score on a scale||Standard Error|Mean
713060|NCT00195819|Secondary|Mean Change in Sacroiliac (SI) Spondyloarthritis Research Consortium of Canada (S.P.A.R.C.C.) Magnetic Resonance Imaging (MRI) Index of Disease Activity Score at Weeks 12 and 52 of Adalimumab Exposure|The S.P.A.R.C.C. MRI index is a tool for scoring inflammation and structural damage in both the spine and sacroiliac (SI) joints. The spinal SPARCC index score consists of 3 subscales (edema, intense edema, and deep edema). Edema was defined as the presence of increased STIR signal in each of 4 Discovertebral unit (DVU) quadrants and was assigned a score (0 = normal signal, 1 = increased signal). The scoring of edema was repeated for each of 3 consecutive sagittal slices with a maximum score of 12 per DVU (range for edema, 0-72). The total spinal SPARCC index score is 0 to 108.|Weeks 12 and 52|Intent-to-treat (ITT) - analysis of all subjects with at least one Baseline MRI were included in the ITT population.||score on a scale||Standard Error|Mean
713061|NCT00195819|Secondary|Mean Change in Spinal Spondyloarthritis Research Consortium of Canada (S.P.A.R.C.C.) Magnetic Resonance Imaging (MRI) Index of Disease Activity Score at Weeks 12 and 52 of Adalimumab Exposure|The S.P.A.R.C.C. MRI index is a tool for scoring inflammation and structural damage in both the spine and sacroiliac (SI) joints. The spinal SPARCC index score consists of 3 subscales (edema, intense edema, and deep edema). Edema was defined as the presence of increased STIR signal in each of 4 Discovertebral unit (DVU) quadrants and was assigned a score (0 = normal signal, 1 = increased signal). The scoring of edema was repeated for each of 3 consecutive sagittal slices with a maximum score of 12 per DVU (range for edema, 0-72). The total spinal SPARCC index score is 0 to 108.|Week 12 and Week 52|Intent-to-treat (ITT) - analysis of all subjects with at least one Baseline MRI were included in the ITT population.||score on a scale||Standard Error|Mean
713062|NCT00195819|Secondary|Mean Change From Baseline in Serum Type I Collagen N-telopeptide (NTx) in Subjects Treated With Any Dose of Adalimumab Through Week 260 of Adalimumab Exposure|Cartilage degradation and bone resorption were assessed by evaluating changes in NTx. A decrease in NTx represents improvement.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||NM BCE||Standard Deviation|Mean
713063|NCT00195819|Secondary|Mean Change From Baseline in Urine Type II Collagen C Telopeptide (CTX-II) in Subjects Treated With Any Dose of Adalimumab Through Week 260 of Adalimumab Exposure|Cartilage and bone degradation were assessed by evaluating changes in CTX-II. A decrease in CTX-II represents improvement.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||ng/mmolcr||Standard Deviation|Mean
713064|NCT00195819|Secondary|Mean Change From Baseline in Serum Matrix Metalloproteinase-3 (MMP-3) in Subjects Treated With Any Dose of Adalimumab Through Week 260 of Adalimumab Exposure|Cartilage and bone degradation were assessed by evaluating changes in MMP-3. A decrease in MMP-3 represents improvement.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||ng/mL||Standard Deviation|Mean
713065|NCT00195819|Secondary|Number of Subjects Achieving the Patient Acceptable Symptoms State Through Week 260 of Adalimumab Exposure|"Completed by subject at each visit. The MCIS was a patient reported outcome where the subjects were expected to respond (yes/no) to the following question:
Considering all the different ways your disease is affecting you, if you would stay in this state for the next months, do you consider that your current state is satisfactory? An increase in PASS indicates improvement.
During earlier weeks of the study PASS was measured/reported as minimal clinically important state (MCIS)."|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||participants|||Number
713066|NCT00195819|Secondary|Number of Subjects With Ankylosing Spondylitis Quality of Life Questionaire (ASQoL) MCID Response (MCID <= -1.8 Points) Through Week 260 of Adalimumab Exposure|"ASQoL determined subject's quality of life comprised of 18 questions to be completed by the subject. Each statement on the ASQoL is given a score of 1 or 0. All item scores were summed to give a total score. Total scores ranged from 0 (good quality of life) to 18 (poor quality of life) related to ability to cope, relationships, mood, sleep, motivation, activities of everyday living, independence, and social life. Decrease in ASQoL score represents improvement. Responders are subjects with MCID <= -1.8 points. MCID was determined by a >= 1.8 score decrease during exposure to adalimumab."|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||participants|||Number
713308|NCT00214487|Primary|Changes in Cycloplegic Autorefraction in One Year.||One year|||Diopters||Standard Deviation|Mean
713067|NCT00195819|Secondary|Mean Change in the Ankylosing Spondylitis Quality of Life Questionaire (ASQoL) in Subjects Through Week 260 of Adalimumab Exposure|"ASQoL determined subject's quality of life and is comprised of 18 questions (yes or no) to be completed by the subject. Each statement on the ASQoL is given a score of 1 or 0. All item scores were summed to give a total score or index. Total scores ranged from 0 (good quality of life) to 18 (poor quality of life) related to ability to cope, relationships, mood, sleep, motivation, activities of everyday living, independence, and social life. Decrease in ASQoL score represents improvement."|Baseline and at Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||score on a scale||Standard Deviation|Mean
713068|NCT00195819|Secondary|Mean Change in Health Utilities Index-3 (HUI-3) Through Week 260 of Adalimumab Exposure|Change from baseline in Health Utility Index Mark 3 (HUI-3) was reported. The HUI-3 is a generic approach to the measurement of health status and assessment of HRQL. The HUI-3 was comprised of two complementary components. The first component was a multi-attribute health status classification system that was used to describe health status. The second component was a multi-attribute utility function that was used to value health status as measured within the corresponding multi-attribute health status classification system. An increase in the HUI-3 score represents improvement.|Weeks 24, 52, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mmg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||score on scale||Standard Deviation|Mean
713069|NCT00195819|Secondary|Number of Subjects With SF-36 Mental Component Summary (MCS) of Minimal Clinically Important Difference (MCID) Response Through Week 260 of Adalimumab Exposure|SF-36 is a standardized survey completed by Subject, evaluating 8 aspects of functional health and well being; physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, and mental health. The score for a section is an average of the individual question scores, which are scaled 0 (no functioning) to 100 (highest level of functioning). Responders are subjects with MCID > 3 points. Minimal clinically important difference (MCID) for PCS was determined by a >= 3.0 point increase during exposure to adalimumab.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||participants|||Number
713070|NCT00195819|Secondary|Mean Change in the SF-36 Health Survey Index Mental Component Summary [MCS] Through Week 260 of Adalimumab Exposure|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being; physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, and mental health. The score for a section is an average of the individual question scores, which are scaled 0 (no functioning) to 100 (highest level of functioning). Change from Baseline in the SF-36 Health Survey Index was completed by Subject. Components of the SF-36 included the PCS and MCS, respectively. An increase in SF-36 PCS or MCS indicated improvement.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||score on scale||Standard Deviation|Mean
713071|NCT00195819|Secondary|Number of Subjects With SF-36 Physical Component Summary (PCS) of Minimal Clinically Important Difference (MCID) Response Through Week 260 of Adalimumab Exposure|"SF-36 is a standardized survey evaluating 8 aspects of functional health and well being; physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, and mental health. The score for a section is an average of the individual question scores, which are scaled 0(no functioning)to 100 (highest level of functioning).
Responders were subjects with MCID > 3 points. Minimal clinically important difference (MCID) for PCS was determined by a >= 3.0 point increase during exposure to adalimumab."|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||participants|||Number
713072|NCT00195819|Secondary|Mean Change in the SF-36 Health Survey Index Physical Component Summary [PCS] Through Week 260 of Adalimumab Exposure|Change from Baseline in the SF-36 Health Survey Index completed by Subject to help subject keep track of how he/she was feeling and how well he/she was able to do usual activities. Components of the SF-36 included the PCS and MCS, respectively. An increase in SF-36 PCS or MCS indicate improvement.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||score on scale||Standard Deviation|Mean
713073|NCT00195819|Secondary|Mean Change in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale in Subjects With Adalimumab Exposure Through Week 260|The FACIT-Fatigue scale: overall score of 13 general questions divided into four primary Quality of Life (QoL) domains: 1) Physical Well-Being, 2) Social/Family Well-Being, 3) Emotional Well-Being, and 4) Functional Well-Being. For each question subject rates his/her condition for the past week on a 5-point scale ranging from 0 (not at all) to 4 (very much). The score ranges from 0 (highest level of fatigue) to 52 with 52 being the lowest level of fatigue.|Baseline and at Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||unit on a scale||Standard Deviation|Mean
713074|NCT00195819|Secondary|Mean Change in Nocturnal Pain in Subjects With Adalimumab Exposure Through Week 260|The subject was to assess his/her nocturnal pain intensity for the past week using a Nocturnal Pain Visual Analog Scale (Nocturnal Pain VAS). The range was 0 to 100 mm with no pain being indicated by 0 and worse possible pain by 100.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||mm||Standard Deviation|Mean
713075|NCT00195819|Secondary|Mean Change in Physician's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260|The physician will globally assess the subject's current disease state using a VAS scale with 0 being very good and 100 being very bad.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||mm||Standard Deviation|Mean
713076|NCT00195819|Secondary|Mean Change From Baseline in the Tender Joint Count for 46 Joints (TJC 46) in Subjects With Adalimumab Exposure Through Week 260 of Adalimumab Exposure|"Assessment of 46 joints for TJC was done by physical examination. Joint tenderness was classified as present (1), absent (0) or injected/replaced (9). The joints assessed were: Sternoclavicular, Acromioclavicular, Shoulder, Elbow, Wrist, Metacarpophalangeal (1-5), Thumb interphalangeal, Proximal interphalangeal (2-5, Knee, Ankle, and Metatarsophalangeal (1-5)."|Weeks 12, 24, 36, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||score on scale||Standard Deviation|Mean
713077|NCT00195819|Secondary|Mean Change in Swollen Joint Count for 44 Joints (44 SJC) in Subjects With Adalimumab Exposure Through Week 260|"Change from Baseline in the swollen joint index. An assessment of 44 joints for SJC done by physical examination. Joint swelling was classified as present (1), absent (0) or injected/replaced (9). The joints assessed were: Sternoclavicular, Acromioclavicular, Shoulder, Elbow, Wrist, Metacarpophalangeal (1-5), Thumb interphalangeal, Proximal interphalangeal (2-5, Knee, Ankle, and Metatarsophalangeal (1-5)."|Weeks 12, 24, 36, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||score on scale||Standard Deviation|Mean
713078|NCT00195819|Secondary|Mean Change in the Bath Ankylosing Spondylitis Global Index (BAS-G) in Subjects With Adalimumab Exposure Through Week 260|BAS-G consisted of two questions that asked the subject to indicate, on a 10 cm VAS, the effect the disease had on their well being over 1) last week, and 2) last 6 months. BAS-G was measured by two VAS scores (0 to 100 mm) to reflect the effect of Ankylosing Spondylitis on subject's well-being over the past week and over the last 6 months, respectively. The average of these two scores was reported. The mean of the two scores give a BAS-G score of 0-10.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||mm||Standard Deviation|Mean
713079|NCT00195819|Secondary|Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Subjects With Adalimumab Exposure Through Week 260|MASES is measured by scoring of entheses of 0 (no tenderness) to 3 (severe tenderness) at 13 sites on the body. The score was derived as the sum of the 13 scores divided by 3 and the total range is 0 (no tenderness) to 13 (severe tenderness).|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||Units on a scale||Standard Deviation|Mean
713080|NCT00195819|Secondary|Mean Change in Chest Expansion (CE) in Subjects With Adalimumab Exposure Through Week 260|"The patient is in a sitting position on the examination table with the hands on the hips. A pen mark is made at the xiphisternum and a tape measure placed around the circumference of the patient's chest at this level. The patient is asked to take a deep breath and to exhale as completely as possible while looking directly ahead. The measurement (in cm) is noted. The patient is asked to inhale as deeply as possible and the measurement (in cm) is noted. The difference in the 2 measurement points (in cm) constitutes the value for CE.
An increase in chest expansion represents improvement"|Weeks 12, 24, 52,104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||cm||Standard Deviation|Mean
713081|NCT00195819|Secondary|Mean Change in Edmonton Ankylosing Spondylitis Metrology Index (EDASMI) in Subjects With Adalimumab Exposure Through Week 260|The EDASMI is a composite spinal mobility index comprised of 4 measures: 1) cervical rotation, 2) lumbar side flexion, 3) chest expansion, and 4) hip internal rotation spread. A grade of 0-4 scoring system was developed for each of the measures. The sum of 4 items (range 0 to 16) provide the EDASMI score. Decrease in EDASMI represents improvement. All EDASMI measures were done with a simple tape measure and recorded in centimeters (cm) by a rheumatologist and a clinician nurse.|Weeks 12, 24, 52, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||cm||Standard Deviation|Mean
713082|NCT00195819|Secondary|Mean Change in the Bath Ankylosing Spondylitis Metrology Index (BASMI) in Subjects With Adalimumab Exposure Through Week 260|BASMI measures the range of motion based on five clinical measurements: 1) cervical rotation, 2) tragus to wall distance, 3) lumbar side flexion, 4) lumbar flexion (modified Schober's) and 5) intermalleolar distance. BASMI 0 = indicates mild disease involvement, 1 = moderate disease, and 2 = severe disease involvement. The results for cervical rotation and lumbar side flexion are the means of the left and right measurements. Scoring range 0-10. The higher the BASMI score, the more severe was the subject's limitation of movement due to their AS.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||cm||Standard Deviation|Mean
713083|NCT00195819|Secondary|Number of Subjects With a Disease Controlling Clinical Response From Adalimumab as Measured in Partial Remission Response in Subjects With Adalimumab Exposure Through Week 260|Evaluation of the mean changes in BASDAI in subjects with adalimumab exposure from Baseline through 5 years for the effect of adalimumab on structural damage. Partial remission was calculated as follows: A value below 20 on a 0 - 100-point scale in each of the four domains of the ASAS (Patient's Global Assessment of Disease Activity, Pain, Function and Inflammation). Partial remission is also regarded as a low disease activity state.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||participants|||Number
713084|NCT00195819|Secondary|Number of Subjects With a Disease Controlling Clinical Response From Adalimumab as Measured in Assessments of Ankylosing Spondylitis Ankylosing Spondylitis (ASAS) 5/6 in Subjects With Adalimumab Exposure Through Week 260|"The change in ASAS 5/6 was evaluated for the effect of adalimumab on structural damage.
ASAS 5/6 criteria is the 20% improvement in 5 out of 6 domains (physical function [BASFI], Total Back Pain, Patient's Global Assessment of Disease Activity, Inflammation [mean of Questions 5 and 6 of the BASDAI], spinal mobility [BASMI], and acute phase reactants [CRP])."|Weeks 12, 16, 20, 24, 30, 36, 42, 48, 52, 64, 76, 88, 104, 116, 128, 140, 156, 168, 180, 192, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||participants|||Number
713085|NCT00195819|Secondary|Number of Subjects With a Disease Controlling Clinical Response From Adalimumab as Measured in Assessments of Ankylosing Spondylitis (ASAS) 40 - Through Week 260 of Adalimumab Exposure|ASAS 40 responder: improvement of >= 40% and absolute improvement of >= 20 units (on a scale of 0 to 100) in >= 3 of the 4 domains: Patient global assessment (VAS score [0-100 scale]); Pain (Total Back Pain VAS score 0-100 scale); Function (BASFI score 0-100 scale); Inflammation (the mean of the two morning stiffness-related BASDAI VAS scores (i.e. the average of items 5 and 6 of the BASDAI. Applied to each scale. In addition, absence of deterioration in the potential remaining domain, where deterioration is defined as a net worsening of > 0 units (on a scale of 0 to 100).|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244 and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||participants|||Number
713086|NCT00195819|Secondary|Mean Change in C-Reactive Protein (CRP) (mg/dL) in Subjects With Adalimumab Exposure Through Week 260|Evaluation of the mean changes in CRP in subjects with adalimumab exposure from Baseline through 5 years. The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation via the use of an ultrasensitive assay. A decrease in the level of CRP indicate reduction in inflammation. A decrease in CRP indicates improvement.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||mg/dL||Standard Deviation|Mean
713087|NCT00195819|Secondary|Mean Change in BASDAI in Subjects With Adalimumab Exposure Through Week 260|The BASDAI is a questionnaire with 6 questions that subject completes by marking answers on a 10-cm Visual Analog Scale (VAS) during the last week with responses that range from 0 (none) to 100 (very severe) and measures severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 (none) to 10 (severe). A decrease in BASDAI represents improvement. BASDAI Scoring: 1) Measure each item of the BASDAI in centimeters (out of a total of 10) 2) BASDAI Score = 0.2 (Item 1 + Item 2 + Item 3 + Item 4 + Item 5/2 + Item 6/2).|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||cm||Standard Deviation|Mean
713088|NCT00195819|Secondary|Number of Subjects With a Reduction of Signs and Symptoms as Measured in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 70 Through Week 260 of Adalimumab Exposure|"The BASDAI is a questionnaire with 6 questions that subject completes by marking answers on a 10-cm Visual Analog Scale (VAS) during the last week with responses that range from 0 (none) to 100 (very severe) and measures severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 to 10. Improvement in BASDAI by 70% was assessed. BASDAI Scoring:
Measure each item of the BASDAI in centimeters (out of a total of 10)
BASDAI Score = 0.2 (Item 1 + Item 2 + Item 3 + Item 4 + Item 5/2 + Item 6/2)."|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||participants|||Number
713089|NCT00195819|Secondary|Number of Subjects With a Reduction of Signs and Symptoms as Measured in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Through Week 260 of Adalimumab Exposure|"The BASDAI is a questionnaire with 6 questions that subject completes by marking answers on a 10-cm Visual Analog Scale (VAS) during the last week with responses that range from 0 (none) to 100 (very severe) and measures severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 to 10. Improvement in BASDAI by 50% was assessed. BASDAI Scoring:
Measure each item of the BASDAI in centimeters (out of a total of 10)
BASDAI Score = 0.2 (Item 1 + Item 2 + Item 3 + Item 4 + Item 5/2 + Item 6/2)."|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||participants|||Number
713090|NCT00195819|Secondary|Number of Subjects With a Reduction of Signs and Symptoms as Measured in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 20 Through Week 260 of Adalimumab Exposure|"The BASDAI is a questionnaire with 6 questions that subject completes by marking answers on a 10-cm Visual Analog Scale (VAS) during the last week with responses that range from 0 (none) to 100(very severe) and measures severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 (none) to 10 (very severe). Improvement in BASDAI by 20% was assessed. BASDAI Scoring:
Measure each item of the BASDAI in centimeters (out of a total of 10)
BASDAI Score = 0.2 (Item 1 + Item 2 + Item 3 + Item 4 + Item 5/2 + Item 6/2)."|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||Participants|||Number
713091|NCT00195819|Secondary|Inflammation (Individual Component of ASAS 20) (Mean of BASDAI Questions 5 and 6) Through Week 260 of Adalimumab Exposure|A responder is a subject who demonstrates an absolute improvement of at least 10 units and a percentage improvement of at least 20% from Baseline in inflammation (mean of the BASDAI questions 5 and 6 on scale of 0 [none] to 10 [very severe].|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||particpants|||Number
713092|NCT00195819|Secondary|Mean Change in Inflammation (Mean of BASDAI Questions 5 and 6) in Subjects With Adalimumab Exposure Through Week 260|The inflammation score is the mean of the two morning stiffness-related BASDAI visual analog scale (VAS) scores (items 5 and 6 of the BASDAI) of 0 (none) to 10 (very severe). A decrease in inflammation represents improvement.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||cm||Standard Deviation|Mean
713093|NCT00195819|Secondary|Total Back Pain (an Individual Component of ASAS 20) Through Week 260 of Adalimumab Exposure|A responder is a subject who demonstrates an absolute improvement of at least 10 units and a percentage improvement of at least 20% from Baseline.|Weeks 12, 24, 52, 76, 128, 152, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||participants|||Number
713094|NCT00195819|Secondary|Mean Change in Total Back Pain Visual Analog Scale (VAS) in Subjects With Adalimumab Exposure Through Week 260|Evaluation of the effect of 40 mg every other week (eow) adalimumab on Total Back Pain VAS. The subject was to assess his/her disease activity in the past week using a total spine VAS on a scale 0 (no pain) to 100 (severe pain).|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||mm||Standard Deviation|Mean
713095|NCT00195819|Secondary|BASFI (an Individual Component of ASAS 20) Through Week 260 of Adalimumab Exposure|BASFI consisted of 10 Visual Analog Scale (VAS) questions with a response ranging from 0 (easy) to 100 (impossible). The BASFI score was derived based on the average of questions 1 through 10. A responder is a subject who demonstrates an absolute improvement of at least 10 units and a percentage improvement of at least 20% from Baseline.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||participants|||Number
713096|NCT00195819|Secondary|Mean Change in the Bath Ankylosing Spondylitis Functional Index (BASFI) in Subjects With Adalimumab Exposure Through Week 260|BASFI consist of a set of 10 questions designed to determine the degree of functional limitation in subjects with AS. The BASFI score was derived based on the average of questions 1 through 10. The first 8 questions considered activities related to functional anatomy and the final 2 questions assessed the subject's ability to cope with everyday life over the last week. A 10 cm visual analog scale (VAS) was used to answer the questions and the mean of the ten scales gave the BASFI score a value between 0 (easy) and 10 (impossible).|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||mm||Standard Deviation|Mean
713097|NCT00195819|Secondary|Number of Subjects With a Reduction of Signs and Symptoms as Measured in Patient's Global Assessment of Disease Activity (an Individual Component of ASAS 20) Through Week 260 of Adalimumab Exposure|The patient assesses his/her disease activity for the past week using a Patient Global Assessment of Disease on visual analog scale (VAS) with 0 being none and 100 being severe.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mmg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||participants|||Number
713098|NCT00195819|Secondary|Mean Change in Patient's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260|Evaluation of the effect of adalimumab 40 mg every other week (eow) on patient's global assessment of disease activity. The patient was to assess his/her disease activity in the past week using a visual analog scale (VAS) on a scale of 0 to 100 mm with no activity being indicated by 0 and severe activity by 100.|Weeks 12, 24, 36, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||mm||Standard Deviation|Mean
713099|NCT00195819|Secondary|Number of Subjects With a Reduction of Signs and Symptoms as Measured in Assessments of Ankylosing Spondylitis (ASAS) ASAS 70 Through Week 260 of Adalimumab Exposure|ASAS 70 responders - improvement of >=70% and absolute improvement of >=30 units (0-100) from Baseline in visual analog scale (VAS) for >=3 of the 4 domains; Patient's Global Assessment of disease activity VAS; (0[none]-100[severe]) Total Back Pain VAS; (0 [no pain]-100 [severe]); BASFI VAS; (0 [easy ]-100[impossible]) and Inflammation VAS; 1 [no pain] to 10 [severe pain]). In addition, absence of deterioration in the potential remaining domain. Applied to each scale and not to an overall global scale.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||participants|||Number
713100|NCT00195819|Secondary|Number of Subjects With a Reduction of Signs and Symptoms as Measured by Assessments in Ankylosing Spondylitis (ASAS) ASAS 50 Through Week 260 of Adalimumab Exposure|ASAS 50 responders - improvement of >=50% and absolute improvement of >=20 units (0-100) from Baseline in visual analog scale (VAS) for >=3 of the 4 domains; Patient's Global Assessment of disease activity; (0[none]-100[severe]) VAS scale; Total Back Pain VAS; (0 [no pain]-100 [severe]); BASFI VAS; (0 [easy ]-100[impossible]) and Inflammation VAS; (1 [no pain] to 10 [severe pain]). In addition, absence of deterioration in the potential remaining domain. Applied to each scale and not overall global scale.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||participants|||Number
713101|NCT00195819|Secondary|Number of Subjects With a Reduction of Signs and Symptoms as Measured in Assessments of Ankylosing Spondylitis (ASAS) 20 - Through Week 260 of Adalimumab Exposure|ASAS 20 responders - improvement of >=20% and absolute improvement of >=10 units from Baseline in a visual analog scale (VAS) 0 [no disease activity]-100 [high disease activity]) for >=3 of 4 domains; Patient's Global Assessment of disease activity VAS; (0[none]-100 [severe]), Total Back Pain VAS; (0 [no pain]-100 [severe]), BASFI VAS (0 [easy ]-100[impossible]); and Inflammation VAS; (1 [no pain] to 10 [severe pain]) and absence of deterioration in the potential remaining domain. Applied to each scale and not to an overall global scale|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||participants|||Number
713102|NCT00195819|Primary|Number of Subjects With a Reduction in Signs and Symptoms as Measured by Assessments of Ankylosing Spondylitis (ASAS) 20 Response at Week 12|ASAS 20 responders - improvement of >=20% and absolute improvement of >=10 units from Baseline in a visual analog scale (VAS) 0 [no disease activity]-100 [high disease activity]) for >=3 of 4 domains; Patient's Global Assessment of disease activity VAS; (0[none]-100 [severe]), Total Back Pain VAS; (0 [no pain]-100 [severe]), BAth Ankylosing Spondylitis Functional Index (BASFI) VAS (0 [easy ]-100[impossible]); and Inflammation VAS; (1 [no pain] to 10 [severe pain]) and absence of deterioration in the potential remaining domain. Applied to each scale and not to an overall global scale.|Week 12|Full analysis set - includes all subjects who were randomized and received at least one injection of study medication. The full analysis set was analyzed by treatment group.||participants|||Number
713103|NCT00196105|Primary|Time to Death|Overall Survival|up to 32 months|||Days||Inter-Quartile Range|Median
713104|NCT00196105|Primary|Number of Deaths||up to 32 months|||Participants|||Number
713105|NCT00196105|Primary|Number of Days to Occlusion||up to 32 months|||Days||Full Range|Median
713106|NCT00196105|Primary|Closure or Blockage of the Stent (Occlusion)|"Biliary stents may become closed or blocked. This is also termed Occlusion. Data for this outcome measure involve stent occlusions that required re-intervention."|up to 32 months|||Stent Occlusions|||Number
713107|NCT00196105|Primary|Patency|Number of days of stent patency: The time to stent occlusion requiring re-intervention, death, loss to follow-up, or patients alive at study end without an occlusion (>= 6 months after placement).|up to 32 months|||Days||Full Range|Median
713108|NCT00196196|Secondary|Percentage of Agreement Between the Codman Valve Position Verification (VPV) System and Consensus X-rays Using Various Thresholds|Percentage of agreement between consensus X-ray readings and the intended setting programmed by the Codman Valve Position Verification (VPV) system. This was assessed at various steps (intervals of mmH20) as increments allow on the Codman Hakim Programmable Valve. (1 step = 10 mmH20, 2 steps = 20 mmH20, +2 steps = >20 mmH20)|Day 1|||Percentage of agreement|||Number
713109|NCT00196196|Primary|"Percentage of Participants Who Achieved Adjustment Complete and a Consensus X-ray Reading"|"Up to 5 attempts to achieve Adjustment Complete using the Codman Valve Position Verification (VPV) system for each Subject. Agreement in 2 of 3 valve X-ray readings by independent radiologists for each Subject was considered consensus X-ray. All participants included achieved Adjustment Complete and a consensus X-ray reading."|Day 1|||Percentage of participants|||Number
713110|NCT00196313|Secondary|Analgesic Use|number of days analgesic (pain) medication was used over the 13 week treatment period|13-week treatment period|Complete Cohort: consisted of all randomized subjects who completed the full term of study participation (13 weeks) and who had no recorded protocol violations that would have excluded the from analysis.||Days Analgesic was used over 13 weeks||Standard Deviation|Mean
713111|NCT00196313|Secondary|Number of Days Missed From School/Work or Other Activities||13-week treatment period|Complete Cohort: consisted of all randomized subjects who completed the full term of study participation (13 weeks) and who had no recorded protocol violations that would have excluded the from analysis.||Days||Standard Deviation|Mean
713112|NCT00196313|Secondary|Incidence of Menstrual Bleeding and /or Spotting||Baseline to end of Week 13|Complete Cohort: consisted of all randomized subjects who completed the full term of study participation (13 weeks) and who had no recorded protocol violations that would have excluded the from analysis.||Days of bleeding/spotting over 13 weeks||Standard Deviation|Mean
713113|NCT00196313|Secondary|Change From Baseline in Maximum Severity of Abdominal/Pelvic Pain|"Maximum pain severity score was calculated by identifying each subject's maximum recorded pain severity from baseline to end of Week 13.
The severity of the pain was assessed using a 4-points scale (0 = “None”, 1 = “Mild”, 2 = “Moderate”, 3 = “Severe”)"|Baseline to end of Week 13|Complete Cohort: consisted of all randomized subjects who completed the full term of study participation (13 weeks) and who had no recorded protocol violations that would have excluded the from analysis.||units on a scale||Standard Error|Least Squares Mean
713114|NCT00196313|Primary|Mean Change in Average Severity for Abdominal/Pelvic Pain|Defined as the sum of pain scores divided by the total number of days in which the subject experienced abdominal/pelvic pain, from baseline to Week 13 The severity of the pain was assessed using a 4-points scale (0 = “None”, 1 = “Mild”, 2 = “Moderate”, 3 = “Severe”)|Baseline to end of 13-week treatment period|Complete Cohort: consisted of all randomized subjects who completed the full term of study participation (13 weeks) and who had no recorded protocol violations that would have excluded the from analysis.||units on a scale||Standard Error|Least Squares Mean
713115|NCT00201825|Secondary|Pharmacokinetics||Cycle 2|No Pharmacokinetics were conducted for this trial.|||||
713116|NCT00201825|Secondary|One Year Survival||one year|||months||95% Confidence Interval|Median
713117|NCT00201825|Secondary|Time to Tumor Progression||Every 35 days|||months||95% Confidence Interval|Median
713118|NCT00201825|Primary|Determine Objective Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Every 35 days|One patient was not evaluable for response because the patient was removed from study afer an adverse event.||patients|||Number
713119|NCT00201838|Secondary|Serial Levels of TNF (Tumor Necrosis Factor) and Other Inflammatory Cytokines||up to 6 months|Compare CBR with responders and non responders with available blood samples.||delta Ct values||Standard Deviation|Mean
713120|NCT00201838|Secondary|Median Overall Survival Rates for Patients|Median survival is defined as the time of initiation of the first dose of intervention to the date of death|up to 1 year|all evaluable patients||months||95% Confidence Interval|Median
713121|NCT00201838|Secondary|Percentage of Patients With Clinical Benefit Response|A clinical benefit was defined by the improvement of at least one parameter over at least 4 weeks, without worsening of any other parameter (change in weight, ECOG performance status, Quality of life).|Up to 12 months|All evaluable patients||percentage of patients|||Number
713122|NCT00201838|Secondary|Number of Patients With Response|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|up to 12 months|"2 patients in the control group were non evaluable for disease response due to patient withdrawal and another no baseline imaging for comparison.
5 patients in experimental group were non evaluable for response."||percentage of patients|||Number
713123|NCT00201838|Primary|Anti-tumor Effect as Measured by the Proportion of Patients Free of Disease-progression at Six Months After Treatment Initiation|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Percentages were calculated by a Kaplan Meier analysis.|up to 6 months|5 patients of the experimental group were non evaluable and 2 patients in the control group were non evaluable for disease progression.||percent of patients with PFS|||Number
713124|NCT00201851|Primary|Disease-free Survival|5-year disease-free survival|two- to three-year accrual and initial two or more years of follow-up period|||percentage of participants|||Number
713125|NCT00201864|Secondary|Examine the Effect of Exemestane + Fulvestrant on Serum IGF-1 and IGFPB-3 Levels||Prestudy, Day 7 and Day 120|Increase in mean levels from baseline to day 120. Not all patients had the IGF-1 and IGFBP-3 levels present.||ng/mL||Standard Deviation|Mean
713126|NCT00201864|Secondary|Maximum Plasma Concentration (Cmax) of Exemestane When Administered Alone and With Fulvestrant|5 mL of venous whole blood was obtained before dosing and then at 1, 2, 4, 6, 8, and 24 hours after exemestane ingestion on each of the 2 time points.|Day 7 and Day 120|Only 9 patients had evaluable PK data collected and analyzed||ng/ml||Standard Deviation|Mean
713367|NCT00209274|Secondary|Mitral Valve Area by Planimetry|Defined as mitral valve area as measured by core lab echocardiography.|24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.||cm^2||Standard Deviation|Mean
713127|NCT00201864|Secondary|Overall Clinical Benefit (Complete Response Rate, Partial Response and Stable Disease)|"Response and progression was evaluated after every 2 cycles by physical examination and imaging studies using the international RECIST criteria.
Complete Response (CR), Partial Response (PR), Overall Response Rate (ORR), Stable Disease (SD), Progressive Disease (PD). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progressive Disease (PD); PD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions; Overall Response Rate (ORR), CR+PR"|Every 2 cycles, up to 1 year|||patients|||Number
713128|NCT00201864|Primary|Time to Progression (TTP) in Women With Hormone Responsive Advanced Breast Cancer Treated With Combination of Exemestane and Fulvestrant.|TTP is defined as the time from first treatment to objective evidence of progression on the basis of radiological evaluation and/or physical exam (if physical examination identifies a site of measurable disease). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Every 2 cycles up to 2 years|||months||95% Confidence Interval|Median
713129|NCT00201877|Secondary|Correlative Studies||During induction (weeks 1-15); PK every 2 months during maintenance.||||||
713130|NCT00201877|Secondary|Progression-free Survival(PFS)||2 years|||percentage of patients||95% Confidence Interval|Number
713131|NCT00201877|Primary|Assess the Toxicity of Combination Rituximab and Velcade™ in Patients With Previously Treated Mantle Cell and Follicular Lymphoma.|The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for adverse event reporting.|Day 1 of each cycle|grade 3 neurotoxicity which consisted of constipation/ileus, sensory or motor neuropathy, or orthostatic hypotension||patients|||Number
713132|NCT00201877|Primary|Overall Response Rate||Every 3 months|||percentage of patients|||Number
713133|NCT00202449|Secondary|Study Days Completed as an Indicator of Medication Tolerability at Weeks 6 & 12||6 and 12 weeks||||||
713134|NCT00202449|Secondary|Change in Quality of Life Will be Assessed by the Quality of Life Inventory at Weeks 6 & 12||6 and 12 weeks||||||
713135|NCT00202449|Secondary|Change in Depressive Symptoms Will be Assessed by the Hamilton Depression Rating Scale at Weeks 6 & 12||6 and 12 weeks||||||
713136|NCT00202449|Secondary|Additional Data on Change in Nightmares Will be Assessed by the PTSD Dream Rating Scale and Nightmare Frequency Questionnaire at Weeks 6 & 12||6 and 12 weeks||||||
713137|NCT00202449|Primary|Change in Global Trauma-related Symptom Severity and Functioning Will be Assessed by the Clinical Global Impression of Change at Week 12|The Clinical Global Impression of Change is a 7-point scale that rates global change compared to baseline (1=markedly improved, 2=moderately improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=moderately worse, 7=markedly worse). The CGIC is used to determine the impact of treat effects on meaningful and distinct change in overall sense of well-being and functioning. This outcome measure evaluates change from baseline to Week 12.|12 weeks|Number of subjects analyzed equals the number of subjects who were able to complete this assessment at week 12 (e.g., completed the study).||scale points||Standard Deviation|Mean
713138|NCT00202449|Primary|Change in Sleep Will be Assessed by the Pittsburgh Sleep Quality Index at Week 12|Pittsburgh Sleep Quality Index is a self-report questionnaire assessing sleep quality and disturbances over a 1-month time interval. A global score is obtained by summing the seven component subscales (total score range: 0-21). A score of 5 or less indicates good sleep quality. A score of more than 5 indicates poor sleep quality. Change is measured from Baseline to Week 12.|12 weeks|Number of subjects analyzed equals the number of subjects who were able to complete this assessment at Week 12 (e.g., completed the study).||scale points||Standard Deviation|Mean
713139|NCT00202449|Primary|Change in Combat Trauma-related Nightmares Will be Assessed by the Clinician Administered PTSD Scale (CAPS) Recurrent Distressing Dreams Item at Week 12|"Item B-2 recurrent distressing dreams of the event is a single item from the Clinician Administered PTSD Scale. The rating consists of two parts: Frequency and Intensity. Symptom frequency rated 0 to 4. Symptom intensity rated 0 to 4. Frequency plus Intensity ratings equal the total score. A higher score is worse; a lower score is better. This outcome measure evaluates the change in score from Baseline to Week 12."|Baseline and Week 12|Number of subjects analyzed equals the number of subjects who were able to complete this assessment at week 12 (e.g., completed the study).||scale points||Standard Deviation|Mean
713140|NCT00202722|Secondary|Patient Satisfaction|Patient satisfaction with remifentanil pain relief by use of questionnaire answered within 24 hours after delivery. Evalutated by a 5-point scale; 1-very satisfied.......5-very dissatisfied.|From start of remifentanil treatment until delivery|||Participants|||Number
713141|NCT00202722|Primary|Pain Score, Visual Analogue Scale (VAS) (Mean Maximal Change in Pain)|Continuous Visual Analogue Scale 0 - 100 millimeters (0=no pain, 100=worst imaginable pain) Registration of pain scores before start and every 15.minute during treatment with remifentanil. Result given is the maximal change in pain score (mean) compared to the baseline value at the given timepoints.|From start with remifentanil treatment until delivery, up to 8 hours.|Per protocol||millimeters||Standard Deviation|Mean
713142|NCT00202839|Secondary|The Percentage of Participants Who Achieved a Virologic Response 48 Weeks After Randomization.|Virologic response was defined as undetectable HCV-RNA level in the blood.|48 weeks after randomization (with 24 weeks of treatment immediately before randomization and either 0 or 24 weeks of treatment immediately after randomization)|Intention to treat [ITT] population||Percentage of Participants|||Number
713143|NCT00202839|Primary|The Percentage of Participants Who Achieved a Sustained Virologic Response (SVR)|Sustained virologic response was defined as hepatitis C virus ribonucleic acid [HCV-RNA] levels below assay detection 24 weeks after termination of anti-HCV therapy|24 weeks of follow-up after either 24 or 48 weeks of anti-HCV therapy|Intention to treat [ITT] population defined as participants who received at least one dose of study medication.||Percentage of participants|||Number
713342|NCT00208949|Secondary|Median Survival of Recipients of Grafts Mobilized With GM+G+CSF (Granulocyte Colony-Stimulating Factor (G-CSF)+ Granulocyte Macrophage (GM)-CSF) and G-CSF (Granulocyte Colony-Stimulating Factor )at the Time of Last Follow up.|Median overall survival|5 years|||months||Full Range|Median
713144|NCT00202878|Secondary|Time to First Occurrence of CV Death, Nonfatal MI, UA With Hospitalization, All Revascularization Occurring ≥30 Days After Randomization, and Non-fatal Stroke (Kaplan-Meier Estimate of Percentage of Participants Experiencing a Qualifying Event)|The time (in months) from study start to the first occurrence of any of the following clinical outcomes was recorded: CV death, non-fatal MI, documented UA that requires admission into a hospital, all revascularization (including non-coronary) occurring at least 30 days after randomization, and non-fatal stroke. A Clinical Endpoints Committee (CEC) reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who experienced CV death, non-fatal MI, unstable angina with hospitalization, all revascularization occurring ≥ 30 days after randomization, and non-fatal stroke within 7 Years from randomization.|Up to approximately 9 years|All participants who were randomly assigned to a treatment arm.||Percentage of Participants||95% Confidence Interval|Number
713145|NCT00202878|Secondary|Time to First Occurrence of Coronary Heart Disease (CHD) Death, Non-fatal MI, or Urgent Coronary Revascularization With PCI or CABG ≥ 30 Days After Randomization (Kaplan-Meier Estimate of Percentage of Participants Experiencing a Qualifying Event)|The time (in months) from study start to the first occurrence of any of the following clinical outcomes was recorded: CHD death, non-fatal MI, or urgent coronary revascularization with PCI or CABG ≥ 30 days after randomization. A Clinical Endpoints Committee (CEC) reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who experienced CHD death, non-fatal MI, or urgent coronary revascularization with PCI or CABG ≥ 30 days after randomization within 7 years from randomization.|Up to approximately 9 years|All participants who were randomly assigned to a treatment arm.||Percentage of Participants||95% Confidence Interval|Number
713146|NCT00202878|Secondary|Time to First Occurrence of Death From Any Cause, Major Coronary Event, or Non-fatal Stroke (Kaplan-Meier Estimate of Percentage of Participants Experiencing a Qualifying Event)|The time (in months) from study start to the first occurrence of any of the following clinical outcomes was recorded: death from any cause, major coronary event (non-fatal myocardial infarction, documented unstable angina requiring hospitalization, or coronary revascularization with percutaneous coronary intervention or coronary artery bypass grafting ≥ 30 days after randomization), or non-fatal stroke. A Clinical Endpoints Committee (CEC) reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who experienced death from any cause, major coronary event, or non-fatal stroke within 7 years from randomization.|Up to approximately 9 years|All participants who were randomly assigned to a treatment arm.||Percentage of Participants||95% Confidence Interval|Number
713147|NCT00202878|Primary|Time to First Occurrence of Cardiovascular Death, Major Coronary Event, or Non-fatal Stroke (Kaplan-Meier Estimate of Percentage of Participants Experiencing a Qualifying Event)|The time (in months) from study start to the first occurrence of any of the following clinical outcomes was recorded: cardiovascular death, major coronary Event (non-fatal myocardial infarction [MI], documented unstable angina [UA] requiring hospitalization, or coronary revascularization with percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) ≥ 30 days after randomization), or non-fatal Stroke. A Clinical Endpoints Committee (CEC) reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who experienced cardiovascular death, major coronary event, or non-fatal stroke within 7 years from randomization.|Up to approximately 9 years|All participants who were randomly assigned to a treatment arm.||Percentage of Participants||95% Confidence Interval|Number
713148|NCT00208325|Secondary|To Compare the Change in Patella Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Bearing Treatment Groups Without Patella Resurfacing in the PCL Sacrificing Arm|The Patella Score is completed by the clinicians and assesses the anterior knee pain, quadriceps strength, ability to rise from a chair and stair climbing. The Patella Score ranges from 3 to 30 points with higher scores indicating better functionality and lower scores indicating poorer functionality.|Change from pre-op to 5 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 62 subjects in the PFC Sigma Fixed Bearing and 60 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||units on a scale||Standard Deviation|Mean
713149|NCT00208325|Secondary|To Compare the Change in Patella Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Bearing Treatment Groups With Patella Resurfacing in the PCL Sacrificing Arm|The Patella Score is completed by the clinicians and assesses the anterior knee pain, quadriceps strength, ability to rise from a chair and stair climbing. The Patella Score ranges from 3 to 30 points with higher scores indicating better functionality and lower scores indicating poorer functionality.|Change from pre-op to 5 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 60 subjects in the PFC Sigma Fixed Bearing and 62 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||units on a scale||Standard Deviation|Mean
713150|NCT00208325|Secondary|To Compare the Change in Patella Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Bearing Treatment Groups Without Patella Resurfacing in the PCL Sacrificing Arm|The Patella Score is completed by the clinicians and assesses the anterior knee pain, quadriceps strength, ability to rise from a chair and stair climbing. The Patella Score ranges from 3 to 30 points with higher scores indicating better functionality and lower scores indicating poorer functionality.|Change from pre-op to 2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 77 subjects in the PFC Sigma Fixed Bearing and 70 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||units on a scale||Standard Deviation|Mean
713151|NCT00208325|Secondary|To Compare the Change in Patella Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Bearing Treatment Groups With Patella Resurfacing in the PCL Sacrificing Arm|The Patella Score is completed by the clinicians and assesses the anterior knee pain, quadriceps strength, ability to rise from a chair and stair climbing. The Patella Score ranges from 3 to 30 points with higher scores indicating better functionality and lower scores indicating poorer functionality.|Change from pre-op to 2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 75 subjects in the PFC Sigma Fixed Bearing and 71 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||units on a scale||Standard Deviation|Mean
713152|NCT00208325|Secondary|To Compare the Percentage of Subjects With Good Quadriceps Strength Between Sigma RP and Sigma Fixed Bearing Treatment Groups Without Patella Resurfacing in the PCL Sacrificing Arm|Quadriceps Strength is assessed by the patient into 1 of 3 categories: Good, Fair, or Poor. The percentage of participants with good quadriceps strength is reported in the data table.|5 Years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 88 subjects in the PFC Sigma Fixed Bearing and 87 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||percentage of participants|||Number
713153|NCT00208325|Secondary|To Compare the Percentage of Subjects With Good Quadriceps Strength Between Sigma RP and Sigma Fixed Bearing Treatment Groups With Patella Resurfacing in the PCL Sacrificing Arm|Quadriceps Strength is assessed by the patient into 1 of 3 categories: Good, Fair, or Poor. The percentage of participants with good quadriceps strength is reported in the data table.|5 Years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 88 subjects in the PFC Sigma Fixed Bearing and 89 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||percentage of participants|||Number
713154|NCT00208325|Secondary|To Compare the Percentage of Subjects With Good Quadriceps Strength Between Sigma RP and Sigma Fixed Bearing Treatment Groups Without Patella Resurfacing in the PCL Sacrificing Arm|Quadriceps Strength is assessed by the patient into 1 of 3 categories: Good, Fair, or Poor. The percentage of participants with good quadriceps strength is reported in the data table.|2 Years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 88 subjects in the PFC Sigma Fixed Bearing and 87 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||percentage of participants|||Number
713155|NCT00208325|Secondary|To Compare the Percentage of Subjects With Good Quadriceps Strength Between Sigma RP and Sigma Fixed Bearing Treatment Groups With Patella Resurfacing in the PCL Sacrificing Arm|Quadriceps Strength is assessed by the patient into 1 of 3 categories: Good, Fair, or Poor. The percentage of participants with good quadriceps strength is reported in the data table.|2 Years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 88 subjects in the PFC Sigma Fixed Bearing and 89 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||percentage of participants|||Number
713156|NCT00208325|Secondary|To Compare the Percentage of Subjects With No Anterior Knee Pain Between Sigma RP and Sigma Fixed Bearing Treatment Groups Without Patella Resurfacing in the PCL Sacrificing Arm|Anterior Knee Pain is assessed by the patient into 1 of 4 categories: None, Mild, Moderate, or Severe. The percentage of participants with no anterior knee pain is reported in the data table.|5 Years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 88 subjects in the PFC Sigma Fixed Bearing and 87 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||percentage of participants|||Number
713157|NCT00208325|Secondary|To Compare the Percentage of Subjects With No Anterior Knee Pain Between Sigma RP and Sigma Fixed Bearing Treatment Groups With Patella Resurfacing in the PCL Sacrificing Arm|Anterior Knee Pain is assessed by the patient into 1 of 4 categories: None, Mild, Moderate, or Severe. The percentage of participants with no anterior knee pain is reported in the data table.|5 Years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 88 subjects in the PFC Sigma Fixed Bearing and 89 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||percentage of participants|||Number
713158|NCT00208325|Secondary|To Compare the Percentage of Subjects With No Anterior Knee Pain Between Sigma RP and Sigma Fixed Bearing Treatment Groups Without Patella Resurfacing in the PCL Sacrificing Arm|Anterior Knee Pain is assessed by the patient into 1 of 4 categories: None, Mild, Moderate, or Severe. The percentage of participants with no anterior knee pain is reported in the data table.|2 Years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 88 subjects in the PFC Sigma Fixed Bearing and 87 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||percentage of participants|||Number
713159|NCT00208325|Secondary|To Compare the Percentage of Subjects With No Anterior Knee Pain Between Sigma RP and Sigma Fixed Bearing Treatment Groups With Patella Resurfacing in the PCL Sacrificing Arm|Anterior Knee Pain is assessed by the patient into 1 of 4 categories: None, Mild, Moderate, or Severe. The percentage of participants with no anterior knee pain is reported in the data table.|2 Years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 88 subjects in the PFC Sigma Fixed Bearing and 89 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||percentage of participants|||Number
713160|NCT00208325|Secondary|To Compare the Survivorship Analysis Results Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|Kaplan Meier survivorship analysis estimates the proportion of a population that will survive past a certain time avoiding a certain event. In this study, the event is removal of any component for any reason, also known as revision for any reason. Survival estimates are provided when 40 devices are left still being followed.|5 Years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 176 subjects in the PFC Sigma Fixed Bearing and 176 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||percentage of participants||95% Confidence Interval|Number
713161|NCT00208325|Secondary|To Compare the Survivorship Analysis Results Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm|Kaplan Meier survivorship analysis estimates the proportion of a population that will survive past a certain time avoiding a certain event. In this study, the event is removal of any component for any reason, also known as revision for any reason. Survival estimates are provided when 40 devices are left still being followed.|2 Years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 170 subjects in the PFC Sigma Fixed Bearing and 161 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||percentage of participants||95% Confidence Interval|Number
713162|NCT00208325|Secondary|To Compare the Survivorship Analysis Results Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|Kaplan Meier survivorship analysis estimates the proportion of a population that will survive past a certain time avoiding a certain event. In this study, the event is removal of any component for any reason, also known as revision for any reason. Survival estimates are provided when 40 devices are left still being followed.|2 Years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 176 subjects in the PFC Sigma Fixed Bearing and 176 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||percentage of participants||95% Confidence Interval|Number
713163|NCT00208325|Secondary|To Compare the Percentage of Subjects With Lateral Release Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm|Lateral release is a surgical procedure to release tight capsular structures (lateral retinaculum) on the outside of the kneecap (patella). It is performed during knee surgery and allows the kneecap to move smoothly in the center of the knee. Rate information was collected at time of study surgery.|Operative|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 170 subjects in the PFC Sigma Fixed Bearing and 161 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||percentage of participants|||Number
713164|NCT00208325|Secondary|To Compare the Percentage of Subjects With Lateral Release Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|Lateral release is a surgical procedure to release tight capsular structures (lateral retinaculum) on the outside of the kneecap (patella). It is performed during knee surgery and allows the kneecap to move smoothly in the center of the knee. Rate information was collected at time of study surgery.|Operative|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 176 subjects in the PFC Sigma Fixed Bearing and 176 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||percentage of participants|||Number
713165|NCT00208325|Secondary|To Compare the Percentage of Subjects With at Least 1 Tibial Radiolucency Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|Tibial Radiolucency observes a radiolucent line (of 0.5mm or wider) on the radiograph around the tibial component.|5 Years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 176 subjects in the PFC Sigma Fixed Bearing and 176 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||percentage of participants|||Number
713166|NCT00208325|Secondary|To Compare the Percentage of Subjects With at Least 1 Tibial Radiolucency Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm|Tibial Radiolucency observes a radiolucent line (of 0.5mm or wider) on the radiograph around the tibial component.|2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 170 subjects in the PFC Sigma Fixed Bearing and 161 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||percentage of participants|||Number
713167|NCT00208325|Secondary|To Compare the Percentage of Subjects With at Least 1 Tibial Radiolucency Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|Tibial Radiolucency observes a radiolucent line (of 0.5mm or wider) on the radiograph around the tibial component.|2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 176 subjects in the PFC Sigma Fixed Bearing and 176 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||percentage of participants|||Number
713168|NCT00208325|Secondary|To Compare the Change in Patella Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|The Patella Score is completed by the clinicians and assesses the anterior knee pain, quadriceps strength, ability to rise from a chair and stair climbing. The Patella Score ranges from 3 to 30 points with higher scores indicating better functionality and lower scores indicating poorer functionality.|Change from pre-op to 5 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 122 subjects in the PFC Sigma Fixed Bearing and 122 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||units on a scale||Standard Deviation|Mean
713343|NCT00208949|Primary|Measure the pDC (Plasmacytoid Dendritic Cells )Content of the Graft||at transplant (1 day)|Sample size determinations for this randomized trial were based on a baseline frequency of mDCs(myeloid dendritic cells) and pDCs( plasmacytoid dendritic cells)within the peripheral blood of 0.5% with a SD equal to the mean (0.5%).||x10 ^ 6 cells/kg||Standard Error|Median
713169|NCT00208325|Secondary|To Compare the Change in Patella Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm|The Patella Score is completed by the clinicians and assesses the anterior knee pain, quadriceps strength, ability to rise from a chair and stair climbing. The Patella Score ranges from 3 to 30 points with higher scores indicating better functionality and lower scores indicating poorer functionality.|Change from pre-op to 2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 153 subjects in the PFC Sigma Fixed Bearing and 144 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||units on a scale||Standard Deviation|Mean
713170|NCT00208325|Secondary|To Compare the Change in Patella Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|The Patella Score is completed by the clinicians and assesses the anterior knee pain, quadriceps strength, ability to rise from a chair and stair climbing. The Patella Score ranges from 3 to 30 points with higher scores indicating better functionality and lower scores indicating poorer functionality.|Change from pre-op to 2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 152 subjects in the PFC Sigma Fixed Bearing and 141 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||units on a scale||Standard Deviation|Mean
713171|NCT00208325|Secondary|To Compare the Change in SF-12 Mental Health Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|The 12-Item Short Form Health Survey (SF-12) is a patient reported outcome survey that represents overall subjective health status by measuring eight health-related parameters (each scored from 0 [poor health] to 100 [better health]): body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. The survey is converted into 2 summary measures that are scored from 0 to 100 (where 100 indicates the highest level of health) - the Physical Component Score (PCS-12) and Mental Component Score (MCS-12).|Change from pre-op to 5 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 107 subjects in the PFC Sigma Fixed Bearing and 109 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||units on a scale||Standard Deviation|Mean
713172|NCT00208325|Secondary|To Compare the Change in SF-12 Mental Health Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm|The 12-Item Short Form Health Survey (SF-12) is a patient reported outcome survey that represents overall subjective health status by measuring eight health-related parameters (each scored from 0 [poor health] to 100 [better health]): body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. The survey is converted into 2 summary measures that are scored from 0 to 100 (where 100 indicates the highest level of health) - the Physical Component Score (PCS-12) and Mental Component Score (MCS-12).|Change from pre-op to 2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 139 subjects in the PFC Sigma Fixed Bearing and 130 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||units on a scale||Standard Deviation|Mean
713173|NCT00208325|Secondary|To Compare the Change in SF-12 Mental Health Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|The 12-Item Short Form Health Survey (SF-12) is a patient reported outcome survey that represents overall subjective health status by measuring eight health-related parameters (each scored from 0 [poor health] to 100 [better health]): body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. The survey is converted into 2 summary measures that are scored from 0 to 100 (where 100 indicates the highest level of health) - the Physical Component Score (PCS-12) and Mental Component Score (MCS-12).|Change from pre-op to 2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 130 subjects in the PFC Sigma Fixed Bearing and 118 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||units on a scale||Standard Deviation|Mean
713174|NCT00208325|Secondary|To Compare the Change in SF-12 Physical Health Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|The 12-Item Short Form Health Survey (SF-12) is a patient reported outcome survey that represents overall subjective health status by measuring eight health-related parameters (each scored from 0 [poor health] to 100 [better health]): body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. The survey is converted into 2 summary measures that are scored from 0 to 100 (where 100 indicates the highest level of health) - the Physical Component Score (PCS-12) and Mental Component Score (MCS-12).|Change from pre-op to 5 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 107 subjects in the PFC Sigma Fixed Bearing and 109 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||units on a scale||Standard Deviation|Mean
713183|NCT00208325|Secondary|To Compare the Change in American Knee Society Function Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|American Knee Society (AKS) function score is a 0-100 point score (where 100 indicates excellent knee function) that evaluates the affected knee. The function score is composed of walking and stair climbing ability.|Change from pre-op to 5 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 124 subjects in the PFC Sigma Fixed Bearing and 125 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||units on a scale||Standard Deviation|Mean
713431|NCT00209274|Secondary|Left Ventricular Status- LVEF|LVEF as determined by the core echo laboratory.|4 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.||percent||Standard Deviation|Mean
713175|NCT00208325|Secondary|To Compare the Change in SF-12 Physical Health Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm|The 12-Item Short Form Health Survey (SF-12) is a patient reported outcome survey that represents overall subjective health status by measuring eight health-related parameters (each scored from 0 [poor health] to 100 [better health]): body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. The survey is converted into 2 summary measures that are scored from 0 to 100 (where 100 indicates the highest level of health) - the Physical Component Score (PCS-12) and Mental Component Score (MCS-12).|Change from pre-op to 2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 139 subjects in the PFC Sigma Fixed Bearing and 130 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||units on a scale||Standard Deviation|Mean
713176|NCT00208325|Secondary|To Compare the Change in SF-12 Physical Health Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|The 12-Item Short Form Health Survey (SF-12) is a patient reported outcome survey that represents overall subjective health status by measuring eight health-related parameters (each scored from 0 [poor health] to 100 [better health]): body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. The survey is converted into 2 summary measures that are scored from 0 to 100 (where 100 indicates the highest level of health) - the Physical Component Score (PCS-12) and Mental Component Score (MCS-12).|Change from pre-op to 2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 130 subjects in the PFC Sigma Fixed Bearing and 118 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||units on a scale||Standard Deviation|Mean
713177|NCT00208325|Secondary|To Compare the Percentage of Subjects With Good Quadriceps Strength Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|Quadriceps Strength is assessed by the patient into 1 of 3 categories: Good, Fair, or Poor. The percentage of participants with good quadriceps strength is reported in the data table.|5 Years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 176 subjects in the PFC Sigma Fixed Bearing and 176 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||percentage of participants|||Number
713178|NCT00208325|Secondary|To Compare the Percentage of Subjects With Good Quadriceps Strength Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm|Quadriceps Strength is assessed by the patient into 1 of 3 categories: Good, Fair, or Poor. The percentage of participants with good quadriceps strength is reported in the data table.|2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 170 subjects in the PFC Sigma Fixed Bearing and 161 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||percentage of participants|||Number
713179|NCT00208325|Secondary|To Compare the Percentage of Subjects With Good Quadriceps Strength Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|Quadriceps Strength is assessed by the patient into 1 of 3 categories: Good, Fair, or Poor. The percentage of participants with good quadriceps strength is reported in the data table.|2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 176 subjects in the PFC Sigma Fixed Bearing and 176 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||percentage of participants|||Number
713180|NCT00208325|Secondary|To Compare the Percentage of Subjects With No Anterior Knee Pain Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|Anterior Knee Pain is assessed by the patient into 1 of 4 categories: None, Mild, Moderate, or Severe. The percentage of participants with no anterior knee pain is reported in the data table.|5 Years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 176 subjects in the PFC Sigma Fixed Bearing and 176 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||percentage of participants|||Number
713181|NCT00208325|Secondary|To Compare the Percentage of Subjects With No Anterior Knee Pain Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm|Anterior Knee Pain is assessed by the patient into 1 of 4 categories: None, Mild, Moderate, or Severe. The percentage of participants with no anterior knee pain is reported in the data table.|2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 170 subjects in the PFC Sigma Fixed Bearing and 161 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||percentage of participants|||Number
713182|NCT00208325|Secondary|To Compare the Percentage of Subjects With No Anterior Knee Pain Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|Anterior Knee Pain is assessed by the patient into 1 of 4 categories: None, Mild, Moderate, or Severe. The percentage of participants with no anterior knee pain is reported in the data table.|2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 176 subjects in the PFC Sigma Fixed Bearing and 176 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||percentage of participants|||Number
713218|NCT00211081|Secondary|Change in 6 Minute Walk Test||performed at first and last visit to determine toleration of daily activity||||||
713219|NCT00211081|Secondary|Change in Cytotkine Panels||drawn at baseline and 4-5 week visit||||||
713220|NCT00211081|Secondary|Change in TNF Alpha||drawn at baseline and 4-5 week visit||||||
713221|NCT00211081|Secondary|Change in Form Assay||drawn at baseline and 4-5 week visit||||||
713222|NCT00211081|Secondary|Change in BNP||drawn at baseline and 4-5 week visit||||||
713184|NCT00208325|Secondary|To Compare the Change in American Knee Society Function Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm|American Knee Society (AKS) function score is a 0-100 point score (where 100 indicates excellent knee function) that evaluates the affected knee. The function score is composed of walking and stair climbing ability.|Change from pre-op to 2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 154 subjects in the PFC Sigma Fixed Bearing and 146 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||units on a scale||Standard Deviation|Mean
713185|NCT00208325|Secondary|To Compare the Change in American Knee Society Function Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|American Knee Society (AKS) function score is a 0-100 point score (where 100 indicates excellent knee function) that evaluates the affected knee. The function score is composed of walking and stair climbing ability.|Change from pre-op to 2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 155 subjects in the PFC Sigma Fixed Bearing and 144 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||units on a scale||Standard Deviation|Mean
713186|NCT00208325|Secondary|To Compare the Change in American Knee Society Knee Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|Change from pre-op to 5 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 122 subjects in the PFC Sigma Fixed Bearing and 120 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||units on a scale||Standard Deviation|Mean
713187|NCT00208325|Secondary|To Compare the Change in American Knee Society Knee Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|Change from pre-op to 2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 152 subjects in the PFC Sigma Fixed Bearing and 143 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||units on a scale||Standard Deviation|Mean
713188|NCT00208325|Secondary|To Compare the Change in American Knee Society Knee Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|Change from pre-op to 2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 154 subjects in the PFC Sigma Fixed Bearing and 143 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||units on a scale||Standard Deviation|Mean
713189|NCT00208325|Secondary|To Compare the Change in Oxford Knee Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|Change from pre-op to 5 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 114 subjects in the PFC Sigma Fixed Bearing and 111 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||units on a scale||Standard Deviation|Mean
713190|NCT00208325|Secondary|To Compare the Change in Oxford Knee Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|Change from pre-op to 2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 134 subjects in the PFC Sigma Fixed Bearing and 118 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||units on a scale||Standard Deviation|Mean
713191|NCT00208325|Secondary|To Compare the Change in Oxford Knee Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|Change from pre-op to 2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 145 subjects in the PFC Sigma Fixed Bearing and 138 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||units on a scale||Standard Deviation|Mean
713192|NCT00208325|Secondary|To Compare the Change in Range of Motion From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|Range of motion is knee flexion (how far the patient can bend their knee) minus knee extension (how far the patient can straighten their knee). The result of this subtraction is the range of motion (bending and straightening) for that knee.|Change from pre-op to 5 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 123 subjects in the PFC Sigma Fixed Bearing and 124 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||degrees||Standard Deviation|Mean
713364|NCT00209274|Secondary|Mitral Valve Area by Pressure Half-time Index|Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.|24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.||cm^2/m^2||Standard Deviation|Mean
713193|NCT00208325|Secondary|To Compare the Change in Range of Motion From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm|Range of motion is knee flexion (how far the patient can bend their knee) minus knee extension (how far the patient can straighten their knee). The result of this subtraction is the range of motion (bending and straightening) for that knee.|Change from pre-op to 2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 170 subjects in the PFC Sigma Fixed Bearing and 161 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||degrees||Standard Deviation|Mean
713194|NCT00208325|Secondary|To Compare the Change in Range of Motion From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|Range of motion is knee flexion (how far the patient can bend their knee) minus knee extension (how far the patient can straighten their knee). The result of this subtraction is the range of motion (bending and straightening) for that knee.|Change from pre-op to 2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 156 subjects in the PFC Sigma Fixed Bearing and 148 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||degrees||Standard Deviation|Mean
713195|NCT00208325|Primary|To Compare the Change in Range of Motion From Pre-op to 1 Year Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm|Range of motion is knee flexion (how far the patient can bend their knee) minus knee extension (how far the patient can straighten their knee). The result of this subtraction is the range of motion (bending and straightening) for that knee.|Change from pre-op to 1 year|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 158 subjects in the PFC Sigma Fixed Bearing and 153 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||degrees||Standard Deviation|Mean
713196|NCT00208325|Primary|To Compare the Change in Range of Motion From Pre-op to 1 Year Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|Range of motion is knee flexion (how far the patient can bend their knee) minus knee extension (how far the patient can straighten their knee). The result of this subtraction is the range of motion (bending and straightening) for that knee.|Change from pre-op to 1 year|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 164 subjects in the PFC Sigma Fixed Bearing and 164 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||degrees||Standard Deviation|Mean
713197|NCT00208325|Primary|To Compare Range of Motion Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm|Range of motion is knee flexion (how far the patient can bend their knee) minus knee extension (how far the patient can straighten their knee). The result of this subtraction is the range of motion (bending and straightening) for that knee.|1 year|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 158 subjects in the PFC Sigma Fixed Bearing and 155 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||degrees||Standard Deviation|Mean
713198|NCT00208325|Primary|To Compare Range of Motion Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|Range of motion is knee flexion (how far the patient can bend their knee) minus knee extension (how far the patient can straighten their knee). The result of this subtraction is the range of motion (bending and straightening) for that knee.|1 year|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 168 subjects in the PFC Sigma Fixed Bearing and 167 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||degrees||Standard Deviation|Mean
713199|NCT00208494|Primary|Composite Success/Failure|The composite success/failure of the implant was made up of radiographic, clinical and revision data. Radiographic success was determined by femoral subsidence =/< 2mm, acetabular migration =/< 2mm, cup inclination =/< 4°, no acetabular or femoral osteolysis, and acetabular and femoral lucencies less than 50% of visible porous coating. Clinical success was determined by a Harris Hip score equal to or greater than 80. A hip (patient) was considered to be a composite success at study endpoint if it was a radiographic and clinical success and no revision of any component had taken place.|At 24 months|Out of the 390 subjects, 84 subjects were removed from the analysis for the following reasons: 2 deaths (1 in each arm); 3 protocol violations (2 COM, 1 MOM); 28 bilateral (12 COM, 16 MOM); 39 subjects had no 24-month Harris Hip score (22 COM, 17 MOM); and 12 subjects had no 24-month x-ray (4 COM, 8 MOM).||Participants|||Number
713200|NCT00208507|Secondary|Complication Rates||On-going to end of study||||||
713201|NCT00208507|Primary|Harris Hip Total Score|The Harris Hip scoring system assigns a numeric value to responses from patients and assessments made by a surgeon. A score of 91-100 is excellent, 81-90 is good, 71-80 is fair, 70 or below is poor. The patient records the following: pain level, need for assistance when walking, presence of a limp, distance able to walk, ability to put on shoes and socks, climb stairs, use public transportation and the length of time one is able to comfortably sit in a chair are all scored.|6 weeks, 6, 12 months and last follow up at 24 months or greater|||Units on a scale||Standard Deviation|Mean
713202|NCT00209417|Secondary|Assessment of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Contrast-enhanced Multi-detector-row Helical Computed Tomography (MDCT) Examination.|"Overall Image Quality rated as Excellent, Good, Sufficient or Insufficient Poor by radiologists blinded to the contrast administration."|Within 2, 3 and 7 days post contrast administration.|||Number of images|Participants||Number
713223|NCT00211172|Primary|Adjusted Mean Monthly Percent of Days Covered With B-blocker Following Intervention Date|The primary outcome measure adherence to B-blocker therapy post intervention. Adherence was measured by the degree of prescription filling in an interval derived from pharmacy prescription records by constructing a proportion-of-days-covered per-month measure, using the quantity dispensed and days supplied from each prescription|9 months|||Adjusted monthly % of days covered||Standard Deviation|Mean
713432|NCT00209274|Secondary|Left Ventricular Status- LVEF|LVEF as determined by the core echo laboratory.|3 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.||percent||Standard Deviation|Mean
713203|NCT00209417|Primary|Assessment of the Incidence Rate of Contrast Medium-Induced Nephropathy (CIN) Between Iodixanol and Iopamidol in Patients With Impaired Renal Function.|"The primary endpoint was the incidence rate of CIN, defined as an intra-individual increase in serum creatinine (SCr) of greater than or equal to 44.2 µmol/L (greater than or equal to 0.5 mg/dL).
Subjects with a pre-contrast (baseline) serum creatinine value greater than or equal to 1.5 mg/dL for males and greater than or equal to 1.3 mg/dL for females or eGFR of less than or equal to 50 mL/min/1.73m squared, and a post-contrast serum creatinine value available on days 2 or 3, administered greater than or equal to100 mL or greater than or equal to 1.5 mL/kg bodyweight IMP, without presence of any major protocol violations, and without evidence of other causes inducing acute renal dysfunction."|From baseline up to 3 days post contrast administration.|To calculate the incidence rate of CIN, divide the number of subjects affected by the total number of subjects dosed in each treatment group.||percentage of subjects||95% Confidence Interval|Number
713204|NCT00209560|Secondary|Time to Fully Alert From the End of the Procedure|Time to Fully Alert, defined as the time to the first of 3 consecutive Modified OAA/S scores of 5 from the end of the surgical procedure, was summarized.|At 2-minute intervals from the end of the procedure until the subject met the criteria for Fully Alert status|The primary analysis for the secondary efficacy endpoint was based on the mITT population. Missing values or incomplete data were not imputed.||minutes||Standard Deviation|Mean
713205|NCT00209560|Primary|Successful Sedation of Subjects, Defined for a Subject as Having 3 Consecutive Scores ≤ 4 on the Modified Observer's Assessment of Alertness/Sedation Scale and Completing the Procedure w/o Alternative Sedative Medications/w/o Manual/Mechanical Ventilation|"The Modified OAA/S (MOAA/S) scale is based on a validated, 6-point rating scale. Scores are not combined.
Score 5 (alert) -- responds readily to name spoken in normal tone Score 4 -- Lethargic response to name spoken in normal tone Score 3 -- Responds only after name is called loudly and/or repeatedly Score 2 -- Responds only after mild prodding or shaking Score 1 -- Responds only after painful trapezius squeeze Score 0 -- Does not respond to painful trapezius squeeze"|Sedation success was assessed at 2 minute intervals until the end of the procedure|The pP1 and mITT population included all subjects randomized,received either fospropofol disodium or midazolam, had at least 1 postdose clinical assessment, and were not terminated due to the Investigator’s decision for nonstudy drug related findings. A 95% confidence interval for the sedation success rate was calculated for each treatment group.||participants||95% Confidence Interval|Number
713206|NCT00210470|Secondary|Correlation of Tumor Response or Immune Competence (Lymphocyte Infiltration) With Disease-Free Survival or Overall Survival|Investigate whether clinical or histological tumor response or improvement in immune competence correlate with DFS and OS|Time from cyclophosphamide administration and time from surgery to death or confirmed recurrent or progressive disease||09/2012||||
713207|NCT00210470|Secondary|Overall Survival|Estimate overall survival (OS) in patients receiving the IRX-2 regimen|Time from cyclophosphamide administration and time from surgery to death or confirmed recurrent or progressive disease||09/2012||||
713208|NCT00210470|Secondary|Disease-free Survival|Estimate disease-free survival (DFS) (defined as time from cyclophosphamide administration and time from surgery to death or clinically apparent, biopsy confirmed recurrent or progressive disease after the completion of initial therapy; margins of resection positive for tumor will not be considered disease recurrence)|Time from cyclophosphamide administration and time from surgery to death or confirmed recurrent or progressive disease||09/2012||||
713209|NCT00210470|Secondary|Immune Competence as Measured by Lymphocyte Infiltration|To assess measures of immune competence following administration of the IRX-2 regimen, including total lymphocyte count, peripheral T-cell count and subpopulation studies, and skin test reactivity|At approx. 21 days, prior to surgery||09/2012||||
713210|NCT00210470|Secondary|Evaluate Patient Tolerance of Surgery and Post-operative Adjuvant Therapy;||Following surgery and post-operative therapy||09/2012||||
713211|NCT00210470|Secondary|Clinical and Histological Tumor Responses||At approx. 21 days, prior to surgery||09/2012||||
713212|NCT00210470|Primary|Number of Participants With Adverse Events and Serious Adverse Events|The frequency of all Adverse Events (greater than 5%) is reported. All Serious Adverse Events were described. The number of deaths during study and their relatedness (or not) to treatment, as well as changes in laboratory measures, were published (see referenced publication for details: Wolf, 2011).|Enrollment through 30 days post-surgery|"27 participants were entered into study and treated. All participants were included in the safety analysis.
Based on safety results, the treatment regimen was tolerated. Further clinical study was recommended to evaluate efficacy."||participants|||Number
713213|NCT00210626|Secondary|Return to Usual Activity (RTUA)|Number of Subjects with Week 24 SF-36 PF Score greater than or equal to their pre-trauma SF-36 PF score. The pre-trauma SF-36 PF score was collected at hosptital discharge and reflects a subjects physical function before they were injured and hospitalized.|Hospital Discharge to Post-Hospital Discharge Week 24|Intention to Treat(ITT)population and completed Week 24 Post-Hospital discharge.||Participants|||Number
713214|NCT00210626|Primary|SF-36 PF Score|Average SF-36 (Medical Outcome Survey Short Form) PF (Physical Function) Score post hospital discharge for each subject. Each subjects SF-36 score is the average of all the post hospital discharge scores. The SF-36 score is a patient reported questionaire related to Physical Function base the score can range from 0 to 100. The worst score is 0 and the best possible score is 100.|Hospital Discharge to Post-Hospital Discharge Week 24|ITT (Intent to Treat), The number of subjects analyzed includes all ITT subjects that did not withdraw from the study prior to hospital discharge.||Units on a scale.||Standard Deviation|Mean
713215|NCT00210639|Primary|Musculoskeletal Adverse Events During the Musculoskeletal Disorder Follow-up Phase|The criteria used to assess Musculoskeletal Adverse Event is based on system organ class “Musculoskeletal and connective tissue disorders” of MedDRA 13.0.|Musculoskeletal Disorder (MSD) Follow-Up phase (ie, up to 5 years after their first dose of antimicrobial therapy, yearly visits for 4 additional years)|Participants (207) who were followed up during the MSD Follow-Up Phase.||Participants|||Number
713216|NCT00211081|Primary|Change in Flow Mediated Dilation|Flow-mediated dilation of the brachial artery will be measured using high-resolution ultrasound. Arterial diameter will be measured above the small cavity in the elbow joint from ultrasound images at rest in response to an increase in blood flow to the area.|Baseline, 4 weeks|||Percentage of brachial artery diameter||Standard Deviation|Mean
713217|NCT00211081|Secondary|Drawn and Conducted at Baseline and 4-5 Weeks After Initial Study.||baseline and 4-5 weeks after initial study||||||
713258|NCT00211510|Secondary|Problem Areas in Diabetes (PAID) Questionnaire Assessed and Compared Between Groups|Questionnaire evaluating subjects'potential fear of hypoglycemia events. Change assessed at Baseline and Week 26 and compared between groups. Likert scale scored with 4 being the worst and 0 being no problem.|Baseline and 26 weeks|||Scores on a scale||Standard Deviation|Mean
713262|NCT00211510|Secondary|Difference in Frequency of Severe Hypoglycemia From Baseline to Week 26|Severe Hypoglycemia as defined by hypoglycemic events requiring the assistance of another person to actively administer carbohydrates, glucagon or other resuscitative actions, as reported by subject. The frequency evaluates the total number of events. This will be analyzed and compared between the two study arms from baseline to week 26.|Baseline and 26 weeks|||hypoglycemic events|||Number
713263|NCT00211510|Primary|Change in A1c From Baseline to 26 Weeks|Change is defined as A1c at Week 26 minus A1c at Baseline in each study arm. The difference between the change in each group will then be analyzed. A1c measure is defined as the percent of glycated hemoglobin using one standardized assay for all subjects.|Baseline and 26 weeks|||Percent glycated hemoglobin||Standard Deviation|Mean
713264|NCT00211536|Secondary|Low Blood Glucose Index (LBGI);|4 to 10 daily blood glucose readings (BG) were required for this measure. LBGI was calculated from BG values collected for 30 days prior to Visit 2 and 30 days following Visits 5 and 7. The continuous measure was compared between the two treatment groups for the three periods with a repeated measures ANOVA using proc mixed. Type 3 least square means for each group were assessed and estimate statements used to make comparisons among the LS means and create confidence intervals on the contrasts.|average from baseline to 12 months|The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set for the purpose of analysis.||mg/dL||95% Confidence Interval|Mean
713265|NCT00211536|Secondary|Mean Amplitude of Glycemic Excursions (MAGE)|MAGE was calculated by taking the arithmetic mean of BG excursions when both ascending and descending segments of the curve exceed one Standard Deviation of the average 24-hour BG value. MAGE was calculated for each subject using SMBG data from periods in which subjects had a minimum of 4 and maximum of 10 readings daily. The overall mean of the mean for each subject for the measure time frame was then calculated. The mean of the results for all subjects in each group were then analyzed and compared between groups both at Baseline and 12 months.|average from baseline to 12 months|The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set for the purpose of analysis.||mg/dL||95% Confidence Interval|Mean
713266|NCT00211536|Secondary|Average Daily Blood Glucose|For each subject, a minimum of two blood glucose readings per day was required for calculation of the average daily mean. The overall mean of the mean for each subject for the measure time frame was then calculated. The mean of the results for all subjects in each group were then analyzed and compared between groups both at Baseline and 12 months.|average from baseline to 12 months|The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set for the purpose of analysis.||mg/dL||95% Confidence Interval|Mean
713267|NCT00211536|Primary|Incidence of Severe Hypoglycemia Events|The total number of severe hypoglycemia events, defined as a clinical episode of hypoglycemia (resulting in seizure or coma, requiring hospitalization, intravenous glucose or glucagon administration), or any hypoglycemia that requires assistance from another person, compared between the two study arms from Baseline to 12 months.|12 months|The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set for the purpose of analysis.||events|||Number
713268|NCT00211536|Primary|Change in HbA1c and Compared Between Groups|To determine whether Intra Peritoneal insulin delivery via MIP results in glycemic control that is equal to or superior (i.e. not inferior to) control with SC therapy (Ho : μ (IP) -μ (SC) ≥ 0.50% A1C), a repeated measures analysis of variance, adjusting for baseline A1C using SAS Proc Mixed was used to compare average A1C trends over time between the two treatment groups (19). Type 3 Least Square (LS) means for each group were assessed. The Estimate statement within SAS proc mixed was used to estimate contrasts among the LS means and confidence intervals for the contrasts.|Baseline and 12 months|The primary efficacy analysis set is the As treated data set and includes all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values.||percent HbA1c||Standard Deviation|Mean
713269|NCT00211692|Secondary|Overall Number of Serious Adverse Events||through end of study up to 72 weeks|||participants|||Number
713270|NCT00211692|Secondary|Participants Achieving SVR Categorized by Time of Response|rapid virologic response assessed at 4 weeks, early virologic response assessed at 8-12 weeks, late virologic response assessed at 16-24 weeks|24 weeks after end of treatment|participants with analyzable data for this outcome||participants|||Number
713271|NCT00211692|Secondary|Number of Participants Discontinuing Early From Study Treatment||through end of study up to 72 weeks|||participants|||Number
713272|NCT00211692|Primary|The Primary Endpoint Would be the Number Who Achieve a Sustained Virologic Response.|Overall sustained virologic response for entire cohort and individual sustained virologic response for different arms of study|24 weeks after the end of treatment|Convenience sample for pilot trial. Analysis is intention to treat.||participants|||Number
713273|NCT00211809|Secondary|Beck Anxiety Inventory|The Beck Anxiety Inventory (BAI) is a 21-question multiple choice, self-report inventory that is used for measuring the severity of anxiety. Scoring is from a 0 (not at all) to 3 (severe) with a total score range of 0-63. Higher total scores indicate more severe anxiety symptoms.|Baseline and up to 16 weeks|||units on a scale||Standard Deviation|Mean
713274|NCT00211809|Secondary|Beck Depression Inventory II|The Beck Depression Inventory II (BDI-II) is a 21 item self-report inventory measuring the severity of depression. Individuals are asked to respond to each question based on a two-week time period. Scoring is from 0 (minimal) to 3 (severe), with total score from 0-63. Higher total scores indicate more severe depressive symptoms.|Baseline and up to 16 weeks|||units on a scale||Standard Deviation|Mean
713365|NCT00209274|Secondary|Mitral Valve Area by Planimetry Index|Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.|24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.||cm^2/m^2||Standard Deviation|Mean
713275|NCT00211809|Secondary|Brown Assessment of Beliefs Scale|The Brown Assessment of Beliefs Scale (BABS) rates the degree of conviction and insight patients have concerning their beliefs. The BABS consists of 7 items: the first 6 items are added to obtain the total BABS score. An additional item (ideas of reference) is not included in the total score. Scoring is from 0 (least severe) to 4 (most severe), with total score from 0 to 24.|Baseline and up to 16 weeks|||units on a scale||Standard Deviation|Mean
713276|NCT00211809|Primary|Body Dysmorphic Disorder Clinical Global Impressions Scale|The Clinical Global Impression-Improvement Scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.|baseline and up to 16 weeks|||units on a scale||Standard Deviation|Mean
713277|NCT00211809|Primary|Yale Brown Obsessive Scale|Yale Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder (BDD-YBOCS) - a 12-item semistructured clinician-rated instrument designed to rate severity of body dysmorphic disorder (BDD) symptoms during the past week. The score for each item ranges from 0 (no symptoms) to 4 (extreme symptoms). The BDD-YBOCS Obsession Subtotal score range is 0-20 and the BDD-YBOCS Compulsion Subtotal score range is 0-20. The BDD-YBOCS Insight/Avoidance Subtotal score range is 0-8. The total BDD-YBOCS score range is from 0 (not present or extremely mild) to 48 (severe). Each item is rated as a composite of all the patient's appearance related obsessions and compulsive behaviors independent of their content.|baseline and up to 16 weeks|||units on a scale||Standard Deviation|Mean
713278|NCT00211809|Primary|Body Dysmorphic Disorder Examination|Body Dysmorphic Disorder Examination - Self Reported (BDDE-SR) score - The BDDE-SR is a 30-item self-rating of BDD symptoms, with a more specific measure of body image dissatisfaction. Each item is rated 0 (no dissatisfaction to 6 (extreme dissatisfaction), with total score from 0 to 180.|baseline and up to 16 weeks|||units on a scale||Standard Deviation|Mean
713279|NCT00211887|Secondary|Change in MRI Composite Score|MRI composite score (Z4 score) - the unweighted sum of the individual Z scores for enhanced tissue volume, T2 lesion burden, equivalence of the T1 hypointense lesion burden, normalized CSF (an inverse measure of atrophy with the appropriate sign so that all scores are directionally compatible – larger is worse) MRI enhancement status at baseline (0, 1-4, and 5 or more enhancing lesions)|Baseline to month 36|Due to participant dropouts, there were less participants analyzed for this particular outcome measure.||z score||Standard Deviation|Mean
713280|NCT00211887|Secondary|Change in the Multiple Sclerosis Functional Composite|"positive indicates improvement
The Multiple Sclerosis Functional Composite (MSFC) is a scale measuring pyramidal functions, sensory functions, cerebellar functions, bowel & bladder functions,brain stem functions, mental functions, and visual functions from 0 to 6.
0= normal 6= severe loss"|Baseline to month 36|Due to participant dropouts, there were less participants analyzed for this particular outcome measure.||units on a scale||Full Range|Median
713281|NCT00211887|Secondary|Confirmed Progression on the Expanded Disability Status Scale|"% with EDSS progression
Confirmed progression in a participant was defined as a 1.0 increase in the EDSS from baseline, when baseline <=5.0; or an increase of 0.5 from baseline, when baseline >=5.5, sustained for 6 months (2 successive quarterly visits), as assessed by the blinded EDSS examiner and confirmed centrally."|Baseline to Month 36|||percentage of participants|||Number
713282|NCT00211887|Primary|ARR - PDEs|Annualized relapse rate of protocol-defined exacerbations Protocol defined relapse – an relapse seen within 7 days of onset, verified by the treating physician and independently observed as a change in EDSS by the examining physician. This relapse is defined as: the appearance of a new symptom or worsening of an old symptom, attributable to MS; accompanied by a change in the neurologic examination (defined as a 0.5 or greater increase in the EDSS over the last scheduled or unscheduled visit or a 2 point change in one functional system or a 1 point change in two functional systems, except bladder and cognitive changes); lasting at least 24 hours in the absence of fever; and preceded by stability or improvement for at least 30 days.|Baseline to Month 36|||relapses per year|||Number
713283|NCT00212134|Secondary|Parenting Stress|The PSI is a 120-item validated self-report measure of parenting stress. PSI is a continuous scale measuring stress with a range of 131 (low stress) to 320 (high stress); the average person's stress scores are between 188 and 252|Phase 1 - Age 12 Months|All those who completed the PSI 3 months after surgery and the PSI at age 12 months||units on a scale||Standard Deviation|Mean
713284|NCT00212134|Secondary|Adherence to Occlusion Therapy|Parental report of the number of hours children wore an patch to occlude the fellow eye.|Phase 1 - 12 months follow-up|Analysis is limited to those with at least 3 reports of adherence before 12 months of age.||Hours patched per day||Standard Deviation|Mean
713285|NCT00212134|Secondary|Parenting Stress|The PSI is a 120-item validated self-report measure of parenting stress. PSI is a continuous scale measuring stress with a range of 131 (low stress) to 320 (high stress); the average person's stress scores are between 188 and 252.|Phase 1 - 3 months post surgery|All those who completed the PSI 3 months after surgery.||units on a scale||Standard Deviation|Mean
713286|NCT00212134|Secondary|Percent of Patients With 1 or More Adverse Events||Study enrollment to age 5 years|||percentage of patients||95% Confidence Interval|Number
713287|NCT00212134|Primary|Visual Acuity - Subjective Assessment at Age 4.5 Years.|Visual acuity estimates were standardized by using the Electronic Visual Acuity Tester (EVAT) at each clinical site. The IATS patients were tested at 4.5 years of age allowing the use of the HOTV recognition acuity test. The Amblyopia Treatment Study protocol for presentation and determination of best corrected visual acuity was followed. Monocular visual acuity was evaluated using single letter optotypes with surround bars presented on the EVAT. The staircase procedure of the ATS projects was followed as this has documented success and reliability with this age group. In order to familiarize the subjects with the HOTV matching test, this test was introduced at the 4.0 year visit and the 4.25 year visit by experienced site personnel.|Phase 2 - Age 4.5 Years|One patient in the intraocular lens group was lost to follow-up.at age 18 months. A second patient in that group had developmental delay and the visual acuity could not be assessed. Therefore, the visual acuity measurements at 4.5 years of age are reported for 55 of the 57 patients randomized to the intraocular lens group.||logMAR units||Inter-Quartile Range|Median
713288|NCT00212134|Secondary|Percent of Patients With 1 or More Intraoperative Complications at Cataract Surgery||Cataract surgery immediately after enrollment|||percentage of patients||95% Confidence Interval|Number
713289|NCT00212134|Primary|Visual Acuity|Visual acuity was measured by standard objective testing procedures at 12 months of age. Monocular grating acuity was assessed by the traveling examiner with the Teller Acuity Cards. This test uses cards with black-on-white lines of varying widths and a set distance apart in a square with fixed dimensions, so the thinner the lines, the more there will be on any given card (cycles/cm). The ability to see thinner lines indicates better vision. The cards with lines are presented simultaneously with a gray card and the child's visual attention is noted. It is presumed that the child will preferentially look at the card with the stripes as it is more interesting. When the lines are too thin and close together so as to be indistinguishable from the gray card, no preferential looking will be noted. The card with the thinnest lines that the child will look at is recorded as the best visual acuity in logMAR units.|Phase 1 - Age 12 months|The number of participants was determined by the sample size estimate necessary to detect a 0.2 logMAR difference (2 lines on the Snellen chart) in the visual acuity between the two groups.||logMAR units||Inter-Quartile Range|Median
713290|NCT00213135|Secondary|Mean Number of Combined Unique (CU) Lesions, Active Time Constant 2 (T2) Lesions, and Active Time Constant 1 (T1) Gadolinium-Enhanced (Gd+) Lesions Per Participant Per Scan|Mean Number of CU lesions, active T2 lesions, and active T1 Gd+ lesions were measured by using magnetic resonance imaging (MRI) scans.|Week 96|The ITT population included all participants who were randomized in the study.||lesions||Standard Error|Least Squares Mean
713291|NCT00213135|Secondary|Time to Disability Progression|Time to disability progression was defined as the time to a sustained increase in EDSS score of at least 1 point if baseline EDSS score between 0.5 and 4.5 inclusively, or at least 1.5 points if the baseline EDSS score was 0, or at least 0.5 point if the baseline EDSS score was at least 5, over a period of at least three months. Expanded disability status scale (EDSS) assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. Tenth Percentile of time to sustained increase in EDSS score was reported using Kaplan-Meier survival curve.|Baseline up to Week 96|The ITT population included all participants who were randomized in the study.||months|||Number
713292|NCT00213135|Secondary|Percentage of Relapse-free Participants|A qualifying relapse was defined as an increase of 2 points in at least one functional system of the EDSS or an increase of 1 point in at least two functional systems (excluding changes in bowel or bladder function or cognition) in the absence of fever, lasting for at least 24 hours and to have been preceded by at least 30 days of clinical stability or improvement. Expanded disability status scale (EDSS) assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated.|Week 96|The ITT population included all participants who were randomized in the study.||percentage of participants|||Number
713293|NCT00213135|Primary|Annualized Qualifying Relapse Rate|A qualifying relapse was defined as an increase of 2 points in at least one functional system of the expanded disability status scale (EDSS) or an increase of 1 point in at least two functional systems (excluding changes in bowel or bladder function or cognition) in the absence of fever, lasting for at least 24 hours and to have been preceded by at least 30 days of clinical stability or improvement. Expanded disability status scale (EDSS) assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to multiple sclerosis [MS]) was calculated. The annualized relapse rate for each treatment group was calculated as the total number of confirmed relapses divided by the total number of days on study multiplied by 365.25.|Week 96|The intention-to-treat (ITT) population included all participants who were randomized in the study.||relapses per year||95% Confidence Interval|Number
713294|NCT00214019|Primary|Sputum Eosinophils (EOS) 24 Hours Post Antigen Challenge|Sputum samples were collected from the participants. Cell counts were made from these samples after treatment with 0.1% dithiothreitol. Percentage of eosinophils were reported. Time frame measurement was 24 hours after the subject had an antigen challenge.|Eosinophils are measured 24 hours after the subject has an antigen challenge|Participants for analysis included any subject that completed that specific treatment phase, even if they did not complete other treatment phases.||Eosinophil percentage||Standard Deviation|Mean
713295|NCT00214201|Other Pre-specified|WBC|White Blood Cell count|36 months +/- 60 days|||K/ul||Standard Deviation|Mean
713296|NCT00214201|Secondary|Serum Creatinine at 36 Months (End of Study)||36 months +/- 60 days|||mg/dl||Standard Deviation|Mean
713297|NCT00214201|Primary|Number of Participants With Biopsy Proven Rejection||3 years|||participants|||Number
713298|NCT00214383|Secondary|Improvement in Asthma Control|A six item survey on a seven point Likert scale measuring daytime and nocturnal asthma symptoms, missed school days and rescue medication use in the previous seven days. Lower scores signal better asthma control.|Baseline compared to the mean of the combined 3, 6, 9, and 12 month scores|Forty two dyads dropped out after randomization. Of these, 16 were from the experimental group and 26 from the control group.||Likert scale||95% Confidence Interval|Mean
713299|NCT00214383|Primary|Number of Symptom-free Days|A comparison in the average number of days that a child goes without asthma symptoms between experimental and control groups are shown below.|Baseline compared to the mean of the combined 3, 6, 9, and 12 month scores|Forty two dyads dropped out after randomization. Of these, 16 were from the experimental group and 26 from the control group.||Days||95% Confidence Interval|Mean
713300|NCT00214383|Primary|Percentage Changed in Adherence Score|A baseline number of participants less dropouts was gauged against the weighted average of the number of participants in study period. The percentage change in adherence from baseline through the study was measured and is reported below, together with confidence intervals.|Baseline compared to the mean of the combined 3, 6, 9, and 12 month scores|Forty two dyads dropped out after randomization. Of these, 16 were from the experimental group and 26 from the control group.||Percent change||95% Confidence Interval|Mean
713301|NCT00214461|Primary|Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With Either One of Three Formulations of the Clostridium Difficile Vaccine or a Placebo Vaccine.||Day 0 to up to 70 days post first vaccination|Safety assessments were on the safety population.||Participants|||Number
713302|NCT00214461|Secondary|Number of Participants Achieving Seroconversion of Serum Immunoglobulin G (IgG) After Vaccination With Either a Formulation of C. Difficile Toxoid Vaccine or a Placebo Vaccine.|Seroconversion was defined as a ≥ 4-fold increase from baseline in a subject’s specific IgG levels: Serum Levels of Anti-toxin Immunoglobulin (IgG) against toxin A and toxin B in enzyme units (EU) were assessed by enzyme linked immunosorbent assay (ELISA).|Day up to Day 236 post first vaccination|Serum anti-toxin levels were assessed in the fully evaluable (Per-Protocol) population.||Participants|||Number
713309|NCT00214526|Secondary|Total Symptom Score (Change From Baseline)|Change from Baseline at 12-Weeks (ON-LABA) and 12-Weeks, 6-Months, and 12-Months (OFF-LABA) Follow-up Visits in Total Symptom Score. Total Symptom Score comprises the sum of six asthma symptom measurements. Each symptom is scored on a scale of 0 to 3 each day by the subject. The sum of the scores for these 6 symptoms comprises the Total Symptom Score, which measures overall asthma symptoms. The maximum score possible is 18. A lower Total Symptom score represents better asthma control.|Baseline, 12 Months|||Units on a scale||Standard Deviation|Mean
713310|NCT00214526|Secondary|Asthma Quality of Life Questionnaire (AQLQ) Score (Change From Baseline)|Change from Baseline at 12-Weeks (ON-LABA) and 12-Weeks, 6-Months, and 12-Months (OFF-LABA) Follow-up Visits in AQLQ score. The AQLQ consists of 32 questions (scale from 1 to 7, where 7 reflects a higher quality of life). The AQLQ score is the mean of the scores from the 32 individual questions. An increase in the AQLQ score indicates a better quality of life. A within-subject change in score of 0.5 represents the minimal important difference (MID).|Baseline, 12 Months|||Units on a scale||Standard Deviation|Mean
713311|NCT00214526|Secondary|Use of Maintenance Medications (Change From Baseline)|Change from Baseline at 12-Months (OFF-LABA) Follow-up Visit in use of maintenance medications (inhaled corticosteroids and/or long-acting beta-agonists).|Baseline, 12 Months|||Subjects|||Number
713312|NCT00214526|Secondary|Use of Rescue Medications (Change From Baseline)|Change from Baseline at 12-Weeks (ON-LABA) and 12-Weeks, 6-Months, and 12-Months (OFF-LABA) Follow-up Visits in use of rescue medications (short acting bronchodilators) measured in puffs per week. Subjects recorded their use of rescue medication for asthma symptoms in their Daily Diary throughout the study.|Baseline, 12 Months|||Puffs/7 Days||Standard Deviation|Mean
713313|NCT00214526|Secondary|Asthma Control Questionnaire (ACQ) Score (Change From Baseline)|Change from Baseline at 12-Weeks (ON-LABA) and 12-Weeks, 6-Months, and 12-Months (OFF-LABA) Follow-up Visits in Asthma Control Questionnaire (ACQ) Score. The ACQ is a self-administered patient questionnaire that assesses individual subject asthma control. The ACQ comprises 6 questions that relate to the patient’s asthma symptoms, activity limitations, and daily rescue bronchodilator use, and FEV1. Each question is scored from 0 (best) to 6 (worst) and averaged, resulting in a total score from 0 to 6. A decrease in the ACQ score indicates better asthma control.|Baseline, 12 Months|||Units on a scale||Standard Deviation|Mean
713314|NCT00214526|Secondary|Peak Expiratory Flow (Morning and Evening) (Change From Baseline)|Change from Baseline at 12-Weeks (ON-LABA) and 12-Weeks, 6-Months, and 12-Months (OFF-LABA) Follow-up Visits in morning and evening Peak Expiratory Flow (PEF). The peak expiratory flow rate measures the maximal rate at which a person can exhale air.|Baseline, 12 Months|||L/min||Standard Deviation|Mean
713315|NCT00214526|Secondary|Methacholine PC20 (Change From Baseline)|"Change from Baseline at 12-Weeks, 6-Months, and 12-Months (OFF-LABA) Follow-up Visits in PC20 - provocative concentration of Provocholine (a brand of methacholine chloride) resulting in a drop of FEV1 of 20% or more from baseline. The patient inhales an aerosol of one or more concentrations of methacholine. The lower the concentration of methacholine that provokes a 20% (or greater) fall in FEV1, the more “responsive” or “hyperresponsive” the airways are. Conversely, a rise in methacholine PC20 indicates airways that have become less reactive."|Baseline, 12 Months|||mg/mL||95% Confidence Interval|Geometric Mean
713316|NCT00214526|Secondary|Post-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline)|Percent change from Baseline at 12-Weeks (ON-LABA) and 12-Weeks, 6-Months, and 12-Months (OFF-LABA) Follow-up Visits in post-bronchodilator forced expiratory volume in 1 second (FEV1) (percent predicted).|Baseline, 12 Months|||Percent Change||Standard Deviation|Mean
713317|NCT00214526|Secondary|Pre-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline)|Percent change from Baseline at 12-Weeks (ON-LABA) and 12-Weeks, 6-Months, and 12-Months (OFF-LABA) Follow-up Visits in pre-bronchodilator forced expiratory volume in 1 second (FEV1) (percent predicted).|Baseline, 12 Months|||Percent Change||Standard Deviation|Mean
713318|NCT00214526|Primary|Mild Exacerbation Rate (OFF-LABA) (Change From Baseline)|Average change from Baseline across 12-Week, 6-Month, and 12-Month (OFF-LABA) Follow-up visits. A mild exacerbation was defined as 2 consecutive days when at least one of the following occurs: 1. Morning peak expiratory flow falls at least 20% below the average morning peak flow recorded during the 7 days immediately prior to Enrollment testing; 2. More than 3 more puffs of rescue short acting bronchodilator are required than the average usage during the 7 days immediately prior to Enrollment testing; 3. Awakening at night with asthma symptoms.|Baseline, 12 Months|||Exacerbations/Subject/Week||Standard Deviation|Mean
713319|NCT00214539|Secondary|Asthma Quality of Life Questionnaire (AQLQ) Score (Change From Baseline)|Change from Baseline at 22-Weeks (Steroid Stable Phase) and 12 Months(Steroid Wean and Reduced Steroid Phase) Follow-up Visits in Asthma Quality of Life Questionnaire (AQLQ) score. The AQLQ is a self-administered patient questionnaire that assesses four aspects or domains of daily life for patients with asthma: symptoms, emotional function, activity limitations, and environmental stimuli. The AQLQ is based on a 2-week recall period and consists of 32 questions, each scored from 1 (Worse) to 7 (Better). An increase in the AQLQ score indicates a better quality of life.|Baseline, 12 Months|||Units on a scale||Standard Deviation|Mean
713320|NCT00214539|Secondary|Asthma Control Questionnaire (ACQ) Score (Change From Baseline)|Change from Baseline at 22-Weeks (Steroid Stable Phase) and 12 Months (Steroid Wean and Reduced Steroid Phase) Follow-up Visits in Asthma Control Questionnaire (ACQ) score. The ACQ is a self-administered patient questionnaire that assesses individual subject asthma control. The ACQ comprises 6 questions that relate to the patient’s asthma symptoms, activity limitations, and daily rescue bronchodilator use, and FEV1. Each question is scored from 0 (Better) to 6 (Worse). The ACQ is based on a one-week recall period. A decrease in the ACQ score indicates better asthma control.|Baseline, 12 Months|||Units on a scale||Standard Deviation|Mean
713321|NCT00214539|Secondary|Post-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline)|Change from Baseline at 22-Weeks (Steroid Stable Phase) and 12 Months(Steroid Wean and Reduced Steroid Phase) Follow-up Visits in forced expiratory volume in one second (FEV1). FEV1 is the volume of air expired during the first second of a maximal effort expiration started at total lung capacity.|Baseline, 12 Months|||Percent Change||Standard Deviation|Mean
713322|NCT00214539|Secondary|Pre-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline)|Change from Baseline at 22-Weeks (Steroid Stable Phase) and 12 Months (Steroid Wean and Reduced Steroid Phase) Follow-up Visits in forced expiratory volume in one second (FEV1). FEV1 is the volume of air expired during the first second of a maximal effort expiration started at total lung capacity.|Baseline, 12 Months|||Percent Change||Standard Deviation|Mean
713323|NCT00214539|Secondary|Total Symptom Score (Change From Baseline)|Change from Baseline at 22-Weeks (Steroid Stable Phase) and 12 Months (Steroid Wean and Reduced Steroid Phase) Follow-up Visits in Total Symptom Score. The Total Symptom Score comprises the sum of six asthma symptom measurements recorded in a Daily Diary. Each of these symptoms is scored on a scale of 0 to 3 each day by the subject. The sum of the scores for these 6 symptoms comprises the Total Symptom Score, which measures overall asthma symptoms. The maximum score possible is 18. A lower Total Symptom Score represents better asthma control.|Baseline, 12 Months|||Units on a scale||Standard Deviation|Mean
713324|NCT00214539|Secondary|Use of Rescue Medications (Change From Baseline)|Change from Baseline at 22-Weeks (Steroid Stable Phase) and 12 Months (Steroid Wean and Reduced Steroid Phase) Follow-up Visits in use of rescue medications. Rescue medications for asthma are short-acting beta-agonists that bring quick relief of asthma symptoms.|Baseline, 12 Months|||Puffs/7 Days||Standard Deviation|Mean
713325|NCT00214539|Secondary|Use of Maintenance Medications (Change From Baseline)|Percent Change from Baseline at 12 Months (Steroid Wean and Reduced Steroid Phase) Follow-up Visit in dose of inhaled and/or oral corticosteroids.|Baseline, 12 Months|||Percent||Standard Deviation|Mean
713326|NCT00214539|Primary|Respiratory Adverse Events Per Subject|Respiratory adverse events (AEs) per subject reported during the Treatment Period, and Post-Treatment Period (Steroid Stable Phase, and Steroid Wean and Reduced Steroid Phase). Results were calculated by dividing the number of respiratory adverse events during each time period by the number of subjects in each group. Statistics were not calculated.|Baseline, 12 Months|||Respiratory Adverse Events/Subject|||Number
713327|NCT00214786|Secondary|The Quality of Life of the Recipients Measured With the RAND 36-item Short Form Health Survey|Averaged score in subscales of 'physical functioning', 'Role limitations due to emotional problems', 'energy/fatigue', 'emotional well-being', 'social functioning', 'pain' and 'general health' in the RAND 36-item short form health survey (SF-36). Full scale range is 0-100 for all subscales with 100 as the best outcome and 0 as the worst outcome.|12 months after transplantation|||Scores on a scale||Full Range|Median
713328|NCT00214786|Secondary|Morbidity Related to the Islet Cell Infusion|Number of participants who experienced serious adverse events related to islet cell infusion|12months after transplantation|||participant|||Number
713329|NCT00214786|Secondary|Morbidity Related to the Immunosuppression Regimen|Number of participants who experienced serious adverse events related to immunosuppression regimen|12 months after transplantation|||participant|||Number
713330|NCT00214786|Secondary|Renal Function|Glomerular filtration rate measured by sodium iothalamate I-125 injection (GLOFIL)|12 months after transplantation|||ml/min||Standard Error|Mean
713331|NCT00214786|Secondary|The Number of Islet Cell Infusions Needed to Achieve Insulin Independence||12 months after transplantation|||number of infusion||Standard Error|Mean
713332|NCT00214786|Secondary|Islet Cell Mass Obtained After Remote Site Processing|The sum of Islet mass obtained after transport using the two-layer preservation method, remote site processing and islet culture. Islet mass as defined by Islet Equivalent per kilogram recipient body weight.|At transplantation|||Islet Equivalent per kilogram||Standard Error|Mean
713333|NCT00214786|Secondary|Change of Insulin Requirements in Patients Who Did Not Become Insulin Independent|Percentage of insulin requirement at month 12 against that at baseline in the patients who did not achieve insulin independence. The percentage less than 100% indicates that subjects reduced insulin requirements 12 months after islet transplantation when compared with those at pre-transplant, while the parentage more than 100% represents that patients needed higher amount of exogenous insulin 12 months after islet transplantation.|12 months after transplantation|||Percent decrease compared to baseline||Standard Error|Mean
713334|NCT00214786|Secondary|Incidence of Hypoglycemic Episodes|Blood glucose <70 mg/dl, number of times reported per month|12 months after transplantation|||episodes per month||Standard Error|Mean
713335|NCT00214786|Secondary|Presence or Absence of Hypoglycemic Unawareness|Number of patients who achieved absence of hypoglycemic unawareness|12 months after transplantation|||participants|||Number
713336|NCT00214786|Primary|Achievement of Insulin Independence at 12-month Post Transplant|To assess the number of patients who achieve insulin independence at 12-month after islet cell transplantation|12 months post transplant|||participant|||Number
713337|NCT00214903|Primary|Arterial Thromboembolism (e.g., Acute Myocardial Infarction and Stroke)|Arterial thromboembolism (ATE) linked to the use of continuous combined HRT containing both drospirenone (DRSP) and estradiol (E2) or to other oral continuous combined HRT preparations.|within 8.5 years|The number of participants refers to the ITT study population. During the course of the study, women could for example stop hormonal treatment at any point of time. Therefore, the woman-years of exposure for each group are provided in addition.||participants|Participants||Number
713338|NCT00214903|Primary|Venous Thromboembolism (e.g., Deep Venous Thrombosis and Pulmonary Embolism)|Venous thromboembolism (VTE) linked to the use of continuous combined HRT containing both drospirenone (DRSP) and estradiol (E2) or to other oral continuous combined HRT preparations.|within 8.5 years|The number of participants refers to the ITT study population. During the course of the study, women could for example stop hormonal treatment at any point of time. Therefore, the woman-years of exposure for each group are provided in addition.||participants|Participants||Number
713339|NCT00215137|Primary|Yale Brown Obsessive Compulsive Scale|The Yale Brown Obsessive Compulsive Scale (YBOCS) is a clinician administered measure of the severity of obsessive compulsive disorder(OCD). Higher scores indicate a greater severity of OCD symptoms. The score can range from a minimum of zero to a maximum of forty.|Open Label Phase Baseline,Randomization Phase Baseline or Beginning|||units on a scale||Standard Deviation|Mean
713340|NCT00215150|Primary|Brief Social Phobia Scale(BSPS)|An observer measure of social phobic symptoms, referred to as the Brief Social Phobia Scale, consists of 11 items, 7 evaluating commonly feared or avoided situations and 4 additional items measuring autonomic distress. A total numerical range of 0-88 is scored on this measure, with higher scores representing greater severity of social anxiety disorder symptoms.The total score is computed as a simple sum of the 11 items.|Baseline, 8 and 16 weeks|The number of participants evaluated in either phase is based on a last observation carried forward analysis requiring at least one visit completed in addition to the first timepoint.||units on a scale||Standard Deviation|Mean
713341|NCT00208767|Primary|Change in the Mean Vessel Wall Area (VMA) of the Carotid Bulb From Baseline to 2 Years|The PI will measure carotid artery thickening with magnetic resonance imaging.|Baseline, 2 years|||mm2||Standard Deviation|Mean
713344|NCT00208975|Primary|Number of Patients's Who Had Complete Response and Partial Response to the Treatment of Fludarabine and Cyclophosphamide Followed by GM-CSF and Rituximab.|"Complete Response (CR): Disappearance of all clinical evidence of active tumor for a minimum of eight weeks and absence of any symptoms related to the tumor.
Partial Response (PR):50% decrease in the sum of the product diameters of all lesions that persist for at least four weeks. No lesion can increase in size and no new lesion can appear during this period.
Stable disease (SD):A tumor that is neither growing nor shrinking.No new tumors have developed"|6 months|||participants|||Number
713345|NCT00209027|Primary|BOLD Activation During fMRI Scanning During Performance of a Monetary Reward Task|fMRI BOLD activation during a reward task will be compared between schizophrenia subjects and controls at Baseline. Schizophrenia subjects will switch their baseline medication to aripiprazole and their BOLD activation during the reward task at Baseline will be compared to the endpoint scan.|Baseline and 12 weeks|Prespecified data not collected because the study was terminated before subjects received aripiprazole.|||||
713346|NCT00209092|Secondary|Long Term Follow up Data on Recurrence and Survival|Number of Patients remained alive and relapse free|2 years|||participants|||Number
713347|NCT00209092|Primary|Number of Participants With Complete Pathologic Response Rate to Pre-operative Treatment in Arm A (Docetaxel for 4 Cycles Followed by Capecitabine for 4 Cycles) or Arm B (Docetaxel + Capecitabine for 8 Cycles) in Patients With Early Stage Breast Cancer.|"Pathologic complete response (pCR): Absence of invasive breast cancer in the breast.
Overall Clinical Response=Complete response(CR-complete disappearance of all measurable malignant disease)+partial response(PR-reduction by at least 30%)
Stable disease (SD): No decrease or <25% increase in the sum of the products of the longest perpendicular diameters of all measurable lesions.
Progressive disease (PD): A 20% or greater increase in a single lesion, OR reappearance of any lesion which has disappeared, OR clear worsening of any evaluable disease OR appearance of any new lesion/site."|1 year|||participants|||Number
713348|NCT00209131|Secondary|Medical Evaluation|Evaluation of pain assessments, lower urinary tract symptoms, side effects of study medication and need for hospitalizations and additional endoscopic procedures.|2 weeks and 3 months||||||
713349|NCT00209131|Primary|Time to Passage of Stone Fragments|Time to passage of stone fragments following shock wave lithotripsy as documented by patient diaries and follow-up radiographic imaging.|2 weeks and 3 months|No analysis was conducted.|||||
713350|NCT00209170|Primary|Response of Participants, Defined by Change in the 21-item Hamilton Depression Rating Scale (HDRS) From Baseline to Week 24|"The 21-item HDRS measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 60, where higher scores indicate greater severity. The HDRS at week 24 was compared to the baseline HDRS and each participant's response was calculated using the below table:
No Response = < 25% change in Depression Rating Scale Score Partial Responder =< 50% to >25% change in Depression Rating Scale Score Responder = 50% or greater change in Depression Rating Scale Score"|Baseline, week 24|Last Observation Carried Forward||participants|||Number
713351|NCT00209274|Secondary|Mitral Valve Area by Planimetry|Defined as mitral valve area as measured by core lab echocardiography.|At Baseline and Discharge (≤14 days of index procedure)|The number of participants analyzed includes subjects who had available follow up data at that time frame.||cm^2||Standard Deviation|Mean
713352|NCT00209274|Secondary|Mitral Valve Area by Pressure Half-time|Defined as mitral valve area as measured by core lab echocardiography.|At Discharge (≤14 days of index procedure)|The number of participants analyzed includes subjects who had available follow up data at that time frame.||cm^2||Standard Deviation|Mean
713353|NCT00209274|Secondary|Mitral Valve Area by Pressure Half-time|Defined as mitral valve area as measured by core lab echocardiography.|4 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.||cm^2||Standard Deviation|Mean
713354|NCT00209274|Secondary|Mitral Valve Area by Planimetry|Defined as mitral valve area as measured by core lab echocardiography.|4 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.||cm^2||Standard Deviation|Mean
713355|NCT00209274|Secondary|Transvalvular Mitral Mean Pressure Gradient (Mean MVG)|Defined as the mean pressure gradient across the mitral valve as measured by echocardiography.|3 year|The number of participants analyzed includes subjects who had available follow up data at that time frame.||mmHg||Standard Deviation|Mean
713356|NCT00209274|Secondary|Transvalvular Mitral Mean Pressure Gradient (Mean MVG)|Defined as the mean pressure gradient across the mitral valve as measured by echocardiography.|4 year|The number of participants analyzed includes subjects who had available follow up data at that time frame.||mmHg||Standard Deviation|Mean
713357|NCT00209274|Secondary|Mitral Valve Area by Pressure Half-time|Defined as mitral valve area as measured by core lab echocardiography.|3 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.||cm^2||Standard Deviation|Mean
713358|NCT00209274|Secondary|Mitral Valve Area by Planimetry|Defined as mitral valve area as measured by core lab echocardiography.|3 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.||cm^2||Standard Deviation|Mean
713359|NCT00209274|Secondary|Cardiac Index|Defined as cardiac index (cardiac output divided by body surface area) as measured by core lab echocardiography.|24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.||L/min/m^2||Standard Deviation|Mean
713360|NCT00209274|Secondary|Cardiac Output|Cardiac output as measured by core lab echocardiography.|24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.||L/min||Standard Deviation|Mean
713361|NCT00209274|Secondary|Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation (MR) in Intention to Treat Strategy Cohort||24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.||participants|||Number
713362|NCT00209274|Secondary|Number of Participants With Incidence of Mitral Valve Replacement||24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.||participants|||Number
713363|NCT00209274|Secondary|Transvalvular Mitral Mean Pressure Gradient (Mean MVG)|Defined as the mean pressure gradient across the mitral valve as measured by echocardiography.|24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.||mmHg||Standard Deviation|Mean
713368|NCT00209274|Secondary|Transvalvular Mitral Mean Pressure Gradient (Mean MVG)|Defined as the mean pressure gradient across the mitral valve as measured by Echocardiography Core Laboratory (ECL).|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.||mmHg||Standard Deviation|Mean
713369|NCT00209274|Secondary|Mitral Valve Area by Pressure Half-time|Defined as mitral valve area as measured by core lab echocardiography.|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.||cm^2||Standard Deviation|Mean
713370|NCT00209274|Secondary|Mitral Valve Area by Pressure Half-time Index|Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.||cm^2/m^2||Standard Deviation|Mean
713371|NCT00209274|Secondary|Mitral Valve Area by Planimetry|Defined as mitral valve area as measured by core lab echocardiography.|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.||cm^2||Standard Deviation|Mean
713372|NCT00209274|Secondary|Mitral Valve Area by Planimetry Index|Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.||cm^2/m^2||Standard Deviation|Mean
713373|NCT00209274|Secondary|Cardiac Index (CI)|Defined as cardiac output divided by body surface area as measured by core lab echocardiography. CI is a normalization of cardiac output to take into account the effect of body size on cardiac output requirements.|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.||L/min/m^2||Standard Deviation|Mean
713374|NCT00209274|Secondary|Cardiac Output|Cardiac output as measured by core lab echocardiography.|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.||L/min||Standard Deviation|Mean
713375|NCT00209274|Secondary|Number of Participants With Incidence of Mitral Valve Replacement||12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.||participants|||Number
713376|NCT00209274|Secondary|Mitral Valve Area by Pressure Half-time Index|Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.|30 Days|The number of participants analyzed includes subjects who had available follow up data at that time frame.||cm^2/m^2||Standard Deviation|Mean
713377|NCT00209274|Secondary|Mitral Valve Area by Pressure Half-time|Defined as mitral valve area as measured by core lab echocardiography.|30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.||cm^2||Standard Deviation|Mean
713378|NCT00209274|Secondary|Transvalvular Mitral Valve Gradient|Defined as the mean pressure gradient across the mitral valve as measured by echocardiography.|Discharge (≤ 14 days following index procedure]|The number of participants analyzed includes subjects who had available follow up data at that time frame.||mmHg||Standard Deviation|Mean
713379|NCT00209274|Secondary|Mitral Valve Area by Planimetry|Defined as mitral valve area as measured by core lab echocardiography.|30 Days|The number of participants analyzed includes subjects who had available follow up data at that time frame.||cm^2||Standard Deviation|Mean
713380|NCT00209274|Secondary|Mitral Valve Area by Planimetry Index|Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.|30 Days|The number of participants analyzed includes subjects who had available follow up data at that time frame.||cm^2/m^2||Standard Deviation|Mean
713381|NCT00209274|Secondary|Number of Participants With Incidence of Discharge to a Nursing Home or Skilled Nursing Facility/Hospital||30 Days|The number of participants analyzed includes subjects who had available follow up data at that time frame.||participants|||Number
713382|NCT00209274|Secondary|Cardiac Index|Defined as cardiac index (cardiac output divided by body surface area) as measured by core lab echocardiography.|30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.||L/min/m^2||Standard Deviation|Mean
713383|NCT00209274|Secondary|Cardiac Output|Cardiac output as measured by core lab echocardiography.|30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.||L/min||Standard Deviation|Mean
713384|NCT00209274|Secondary|Number of Participants With New Coumadin (Warfarin) Usage||12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.||participants|||Number
713385|NCT00209274|Secondary|Number of Participants With New Coumadin (Warfarin) Usage||30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.||participants|||Number
713386|NCT00209274|Secondary|Number of Participants With Hospital Re-admissions|Defined as re-admission to the hospital for any reason. The endpoint was intended to capture each time a patient was re-admitted to the hospital for any reason and was to be reported as a rate through 30 days and 12 months for both the Device and Control groups.|30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.||participants|||Number
713387|NCT00209274|Secondary|Number of Participants With Dysrhythmia||12 months|||Participants|||Count of Participants
713388|NCT00209274|Secondary|Number of Participants With Dysrhythmia||30 days|||Participants|||Count of Participants
713389|NCT00209274|Secondary|Number of Participants With MAE in Patients Over 75 Years of Age.||30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.||Participants|||Count of Participants
713390|NCT00209274|Secondary|Number of Participants With MAEa Surgery After Device and First Time Surgery Control||30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.||Participants|||Count of Participants
713391|NCT00209274|Secondary|Number of Participants With Procedural Freedom From In-hospital MAE||Day 30|The number of participants analyzed includes subjects who had available follow up data at that time frame.||Participants|||Count of Participants
713433|NCT00209274|Secondary|Left Ventricular Status- LVEF|LVEF as determined by the core echo laboratory.|24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.||percent||Standard Deviation|Mean
713434|NCT00209274|Secondary|Left Ventricular Status- LVEF|LVEF as determined by the core echo laboratory.|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.||percent||Standard Deviation|Mean
713392|NCT00209274|Secondary|New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV|"Class I: Patients with cardiac disease but without resulting limitations of physical activity.
Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.
Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|4 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.||Percentage of participants|||Number
713393|NCT00209274|Secondary|New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV|"Class I: Patients with cardiac disease but without resulting limitations of physical activity.
Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.
Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|3 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.||Percentage of participants|||Number
713394|NCT00209274|Secondary|New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV|"Class I: Patients with cardiac disease but without resulting limitations of physical activity.
Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.
Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|2 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.||Percentage of participants|||Number
713395|NCT00209274|Secondary|New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV|"Class I: Patients with cardiac disease but without resulting limitations of physical activity.
Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.
Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.||Percentage of participants|||Number
713396|NCT00209274|Secondary|New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV|"Class I: Patients with cardiac disease but without resulting limitations of physical activity.
Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.
Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.||Percentage of participants|||Number
713397|NCT00209274|Secondary|Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.|"Class I: Patients with cardiac disease but without resulting limitations of physical activity.
Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.
Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|4 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.||Participants|||Count of Participants
713398|NCT00209274|Secondary|Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.|"Class I: Patients with cardiac disease but without resulting limitations of physical activity.
Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.
Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|3 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.||Participants|||Count of Participants
713435|NCT00209274|Secondary|Left Ventricular Status- LVEF|LVEF as determined by the core echo laboratory at 30 days or hospital discharge, whichever is longer.|30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.||percent||Standard Deviation|Mean
713399|NCT00209274|Secondary|Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.|"Class I: Patients with cardiac disease but without resulting limitations of physical activity.
Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.
Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.||Participants|||Count of Participants
713400|NCT00209274|Secondary|Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.|"Class I: Patients with cardiac disease but without resulting limitations of physical activity.
Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.
Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.||Participants|||Count of Participants
713401|NCT00209274|Secondary|Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.|Class I Patients with cardiac disease but without resulting limitations of physical activity. Class II Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain. Class IV Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.|30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.||Participants|||Count of Participants
713402|NCT00209274|Secondary|Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.|"Class I: Patients with cardiac disease but without resulting limitations of physical activity.
Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.
Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|Baseline|ITT population.||Participants|||Count of Participants
713403|NCT00209274|Secondary|Number of Participants With Clinically Significant Atrial Septal Defect (ASD)|Defined as a significant residual atrial septal opening. Reported as clinically significant if intervention is performed for the primary purpose of repairing the ASD. If cardiac surgery is indicated for reasons other than residual ASD (e.g., residual MR) and the ASD is repaired at the same time, this does not meet the definition of clinically significant ASD.|12 months|||participants|||Number
713404|NCT00209274|Secondary|Number of Participants With Endocarditis.|Defined as a diagnosis of endocarditis based on the Duke criteria. From The American College of Cardiology (ACC)/American Heart Association (AHA) Guidelines for the Management of Patients with Valvular Heart Disease, Journal of the American College of Cardiology (JACC), Vol 32, No.5, November 1, 1998: pg1541, Table 21.|12 months|||participants|||Number
713405|NCT00209274|Secondary|Number of Participants With Thrombosis.|Defined as evidence of the formation of an independently moving thrombus on any part of the MitraClip or any commercially available implant used during surgery by echocardiography or fluoroscopy.|12 months|||participants|||Number
713406|NCT00209274|Secondary|Number of Participants With Hemolysis|"Defined as new onset of anemia associated with laboratory evidence of red cell destruction. Diagnosed when plasma free hemoglobin is greater than 40 mg/dL on repeat measures within 24 hours or on one measure if intervention is initiated based on other clinical symptoms. Reported as major or minor as defined below:
Major: Requires intervention with red blood cell transfusion or other hematocrit increasing measures in the absence of other obvious bleeding.
Minor: Does not require intervention."|12 months|||participants|||Number
713407|NCT00209274|Secondary|Number of Participants With MAE in Patients Over 75 Years of Age.||12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.||Participants|||Count of Participants
713408|NCT00209274|Secondary|Post-procedure Intensive Care Unit (ICU) / Critical Care Unit (CCU) Duration||30 Days|The number of participants analyzed includes subjects who had available follow up data at that time frame.||hours||Standard Deviation|Mean
713409|NCT00209274|Secondary|Number of Participants With Major Bleeding Complications.|Major Bleeding Complications defined as procedure related bleeding that requires a transfusion of ≥2 units of blood products and/or surgical intervention at 12 months.|12 months|||participants|||Number
713410|NCT00209274|Secondary|Number of Participants With Major Vascular Complications|"Vascular Complications defined as the occurrence of any of the following resulting through 30 days or hospital discharge, whichever is longer:
Hematoma at access site >6 cm;
Retroperitoneal hematoma;
Arteriovenous (AV) fistula;
Symptomatic peripheral ischemia / nerve injury or the clinical signs or symptoms lasting >48 hours;
Vascular Surgical Repair at catheter access sites;
Pulmonary embolism;
Ipsilateral deep vein thrombus; or
Access site-related infection requiring intravenous antibiotics and/or extended hospitalization."|30 days|||participants|||Number
721295|NCT00307047|Secondary|Ischemia Driven Target Vessel Failure (TVF)|Defined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR|2 years|ITT, @ 2 years||percentage of participants|||Number
713411|NCT00209274|Secondary|Number of Participants With Major Vascular Complications|"Vascular Complications defined as the occurrence of any of the following resulting through 30 days or hospital discharge, whichever is longer:
Hematoma at access site >6 cm;
Retroperitoneal hematoma;
Arteriovenous (AV) fistula;
Symptomatic peripheral ischemia / nerve injury or the clinical signs or symptoms lasting >48 hours;
Vascular Surgical Repair at catheter access sites;
Pulmonary embolism;
Ipsilateral deep vein thrombus; or
Access site-related infection requiring intravenous antibiotics and/or extended hospitalization."|12 months|||participants|||Number
713412|NCT00209274|Secondary|Number of Participants With Major Adverse Events (MAE)||12 months.|Intent to treat (ITT) population.||participants|||Number
713413|NCT00209274|Secondary|Number of Participants With Non-cerebral Thromboembolism.|Defined as any thrombus or thromboembolism in the vasculature (excluding central nervous system events) or on the investigational device or any commercially available implant used during surgery confirmed by standard clinical and laboratory testing and which requires treatment.|12 months|||participants|||Number
713414|NCT00209274|Secondary|Number of Participants With Clinically Significant Atrial Septal Defect (ASD).|Defined as a significant residual atrial septal opening. Reported as clinically significant if intervention is performed for the primary purpose of repairing the ASD. If cardiac surgery is indicated for reasons other than residual ASD (e.g., residual MR) and the ASD is repaired at the same time, this does not meet the definition of clinically significant ASD.|30 days|||participants|||Number
713415|NCT00209274|Secondary|Number of Participants With Thrombosis.|Defined as evidence of the formation of an independently moving thrombus on any part of the MitraClip or any commercially available implant used during surgery by echocardiography or fluoroscopy.|30 days|||participants|||Number
713416|NCT00209274|Secondary|Number of Participants With Major Bleeding Complications.|Major Bleeding Complications defined as procedure related bleeding that requires a transfusion of ≥2 units of blood products and/or surgical intervention at 30 days or hospital discharge, whichever is longer.|30 days|||Participants|||Count of Participants
713417|NCT00209274|Secondary|Number of Participants With Hemolysis|"Defined as new onset of anemia associated with laboratory evidence of red cell destruction. Diagnosed when plasma free hemoglobin is greater than 40 mg/dL on repeat measures within 24 hours or on one measure if intervention is initiated based on other clinical symptoms. Reported as major or minor as defined below:
Major: Requires intervention with red blood cell transfusion or other hematocrit increasing measures in the absence of other obvious bleeding.
Minor: Does not require intervention."|30 days|||participants|||Number
713418|NCT00209274|Secondary|Post-procedure Length of Hospital Stay||30 Days|The number of participants analyzed includes subjects who had available follow up data at that time frame.||days||Standard Deviation|Mean
713419|NCT00209274|Secondary|Number of Participants With Non-cerebral Thromboembolism.|Defined as any thrombus or thromboembolism in the vasculature (excluding central nervous system events) or on the investigational device or any commercially available implant used during surgery confirmed by standard clinical and laboratory testing and which requires treatment.|30 days|||participants|||Number
713420|NCT00209274|Secondary|Left Ventricular Internal Dimension Diastole (LVIDd)|Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory at 24 months.|4 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.||cm||Standard Deviation|Mean
713421|NCT00209274|Secondary|Left Ventricular Internal Dimension Diastole (LVIDd)|Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory at 24 months.|3 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.||cm||Standard Deviation|Mean
713422|NCT00209274|Secondary|Left Ventricular Internal Dimension Diastole (LVIDd)|Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory at 24 months.|24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.||cm||Standard Deviation|Mean
713423|NCT00209274|Secondary|Left Ventricular Internal Dimension Diastole (LVIDd)|Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory at 12 months.|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.||cm||Standard Deviation|Mean
713424|NCT00209274|Secondary|Left Ventricular Internal Dimension Diastole (LVIDd)|Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory.|30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.||cm||Standard Deviation|Mean
713425|NCT00209274|Secondary|Left Ventricular Internal Dimension Systole (LVIDs)|Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.|4 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.||cm||Standard Deviation|Mean
713426|NCT00209274|Secondary|Left Ventricular Internal Dimension Systole (LVIDs)|Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.|3 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.||cm||Standard Deviation|Mean
713427|NCT00209274|Secondary|Left Ventricular Internal Dimension Systole (LVIDs)|Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.|2 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.||cm||Standard Deviation|Mean
713428|NCT00209274|Secondary|Left Ventricular Internal Dimension Systole (LVIDs)|Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.||cm||Standard Deviation|Mean
713429|NCT00209274|Secondary|Left Ventricular Internal Dimension Systole (LVIDs)|Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.|30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.||cm||Standard Deviation|Mean
713430|NCT00209274|Secondary|Number of Participants With Endocarditis.|Defined as a diagnosis of endocarditis based on the Duke criteria.From The American College of Cardiology (ACC)/American Heart Association (AHA) Guidelines for the Management of Patients with Valvular Heart Disease, Journal of the American College of Cardiology (JACC), Vol 32, No.5, November 1, 1998: pg1541, Table 21.|30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.||participants|||Number
713436|NCT00209274|Secondary|Left Ventricular Status- LVEDV, LVESV|Left Ventricular Status is defined as including LV end-diastolic volume (LVEDV), LV end-systolic volume (LVESV), as determined by the core echo laboratory at 24 months.|4 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.||ml||Standard Deviation|Mean
713437|NCT00209274|Secondary|Left Ventricular Status- LVEDV, LVESV|Left Ventricular Status is defined as including LV end-diastolic volume (LVEDV), LV end-systolic volume (LVESV), as determined by the core echo laboratory at 24 months.|3 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.||ml||Standard Deviation|Mean
713438|NCT00209274|Secondary|Left Ventricular Status- LVEDV, LVESV|Left Ventricular Status is defined as including LV end-diastolic volume (LVEDV), LV end-systolic volume (LVESV), as determined by the core echo laboratory at 24 months.|24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.||mL||Standard Deviation|Mean
713439|NCT00209274|Secondary|Left Ventricular Status- LVEDV, LVESV|Left Ventricular Status is defined as including LV end-diastolic volume (LVEDV), LV end-systolic volume (LVESV),as determined by the core echo laboratory at 12 months.|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.||ml||Standard Deviation|Mean
713440|NCT00209274|Secondary|Left Ventricular Status- LVEDV, LVESV|Left Ventricular Status is defined a including Left ventricular (LV) end-diastolic volume (LVEDV), LV end-systolic volume (LVESV), as determined by the core echo laboratory at 30 days or hospital discharge, whichever is longer.|30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.||ml||Standard Deviation|Mean
713441|NCT00209274|Secondary|Number of Participants With MR Severity|MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe|4 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.||Participants|||Count of Participants
713442|NCT00209274|Secondary|Number of Participants With MR Severity|MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe|3 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.||Participants|||Count of Participants
713443|NCT00209274|Secondary|Number of Participants With MR Severity|MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe|24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.||Participants|||Count of Participants
713444|NCT00209274|Secondary|Number of Participants With MR Severity|MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.||Participants|||Count of Participants
713445|NCT00209274|Secondary|Number of Participants With MR Severity|"MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe.
“Discharge” refers to each individual patient’s date of hospital discharge. The discharge date varies for each patient, but in general, discharge occurs before 30-days follow-up. A 30-day echocardiogram will be used if the discharge echocardiogram is unavailable or otherwise uninterpretable."|30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.||Participants|||Count of Participants
713446|NCT00209274|Secondary|Freedom From All-Cause Mortality||4 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.||Percentage of participants|||Number
713447|NCT00209274|Secondary|Freedom From All-Cause Mortality||3 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.||Percentage of participants|||Number
713448|NCT00209274|Secondary|Freedom From All-Cause Mortality||24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.||Percentage of participants|||Number
713449|NCT00209274|Secondary|Freedom From All-Cause Mortality||12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.||Percentage of participants|||Number
713450|NCT00209274|Secondary|Number of Participants With MitraClip Device Embolization/Single Leaflet Device Attachment|Device Embolization is defined as the complete detachment of the MitraClip Device from one or both mitral leaflets. Single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device. The control group did not receive the MitraClip device|12 months to 3 years|Not applicable for Mitral valve surgery patients as device was not implanted.||participants|||Number
713451|NCT00209274|Secondary|Number of Participants With MitraClip Device Embolization/Single Leaflet Device Attachment|Device Embolization is defined as the complete detachment of the MitraClip Device from one or both mitral leaflets. Single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device. The control group did not receive the MitraClip device|12 months to 4 years|Not applicable for Mitral valve surgery patients as device was not implanted.||participants|||Number
713452|NCT00209274|Secondary|Number of Participants With Mitral Valve Stenosis|Defined as a mitral valve (MV) planimetered orifice area of less than 1.5 cm^2 as measured by echocardiography. A “confirmed” case of MV stenosis is defined as Echocardiography Core Lab (ECL) measured mitral valve orifice area < 1.5 cm^2. A “conservative” case of MV stenosis is defined as stenosis suspected by the site, based on hemodynamic measurements or clinical symptoms.|4 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.||participants|||Number
713453|NCT00209274|Secondary|Number of Participants With Mitral Valve Stenosis|Defined as a mitral valve (MV) planimetered orifice area of less than 1.5 cm^2 as measured by echocardiography. A “confirmed” case of MV stenosis is defined as Echocardiography Core Lab (ECL) measured mitral valve orifice area < 1.5 cm^2. A “conservative” case of MV stenosis is defined as stenosis suspected by the site, based on hemodynamic measurements or clinical symptoms.|3 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.||participants|||Number
713454|NCT00209274|Secondary|Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation|Durability estimates: Freedom from Death and Mitral Valve Surgery/Re-operation|3 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.||participants|||Number
713455|NCT00209274|Secondary|Number of Participants With Freedom From Mitral Valve Surgery/Re-operation|Durability estimates: Freedom from Mitral Valve Surgery/Re-operation|3 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.||participants|||Number
713456|NCT00209274|Secondary|Number of Participants With Freedom From Death, Mitral Valve Surgery/Re-operation and MR > 2+|Durability estimates: Freedom from Death, Mitral Valve Surgery/Re-operation and MR > 2+|24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.||participants|||Number
713457|NCT00209274|Secondary|Number of Participants With Freedom From Death, Mitral Valve Surgery/Re-operation and MR > 2+|Durability estimates: Freedom from Death, Mitral Valve Surgery/Re-operation and MR > 2+|3 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.||participants|||Number
713458|NCT00209274|Secondary|Number of Participants With Freedom From Mitral Valve Surgery/Re-operation|Durability estimates: Freedom from Mitral Valve Surgery/Re-operation|24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.||participants|||Number
713459|NCT00209274|Secondary|Number of Participants With Durability of the MitraClip Device and Surgery.|"Device group: Freedom from death, surgery for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval.
Control group: Freedom from death, re-operation for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval."|24 months-3 year|The number of participants analyzed includes subjects who had available follow up data at that time frame.||participants|||Number
713460|NCT00209274|Secondary|Number of Participants With Durability of the MitraClip Device and Surgery.|"Device group: Freedom from death, surgery for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval.
Control group: Freedom from death, re-operation for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval."|18-24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.||participants|||Number
713461|NCT00209274|Secondary|Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation|Durability estimates: Freedom from Death and Mitral Valve Surgery/Re-operation|24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.||participants|||Number
713462|NCT00209274|Secondary|Regurgitant Volume|Regurgitant volume as determined by the core echo laboratory.|24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.||mL||Standard Deviation|Mean
713463|NCT00209274|Secondary|Regurgitant Fraction|Regurgitant fraction as determined by the core echo laboratory. Regurgitant fraction is defined as the regurgitant volume divided by the forward stroke volume through the regurgitant valve.|24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.||percentage||Standard Deviation|Mean
713464|NCT00209274|Secondary|Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation.||24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.||participants|||Number
713465|NCT00209274|Secondary|Number of Participants With Mitral Valve Repair Success.|Defined as freedom from mitral valve replacement surgery for Valve Dysfunction, death, re-operation, and MR > 2+ at 12 months.|24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.||participants|||Number
713466|NCT00209274|Secondary|Number of Participants With MitraClip Device Embolization/Single Leaflet Device Attachment|Device Embolization is defined as the complete detachment of the MitraClip Device from one or both mitral leaflets. Single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device. The control group did not receive the MitraClip device.|12 months|Not applicable for Mitral valve surgery patients as device was not implanted.||participants|||Number
713467|NCT00209274|Secondary|Number of Participants With Mitral Valve Stenosis|Defined as a mitral valve planimetered orifice area of less than 1.5 cm^2 as measured by echocardiography.|24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.||participants|||Number
713468|NCT00209274|Secondary|Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation|Durability estimates: Freedom from Death and Mitral Valve Surgery/Re-operation|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.||participants|||Number
713469|NCT00209274|Secondary|Number of Participants With Freedom From Death, Mitral Valve Surgery/Re-operation and MR > 2+|Durability estimates: Freedom from Death, Mitral Valve Surgery/Re-operation and MR > 2+|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.||participants|||Number
713470|NCT00209274|Secondary|Number of Participants With Procedural Freedom From MAE.||Day 0|The number of participants analyzed includes subjects who had available follow up data at that time frame.||participants|||Number
713471|NCT00209274|Secondary|Number of Participants With Durability of the MitraClip Device and Surgery.|"Device group: Freedom from death, surgery for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval.
Control group: Freedom from death, re-operation for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval."|12-18 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.||participants|||Number
713472|NCT00209274|Secondary|Number of Participants With Freedom From Mitral Valve Surgery/Re-operation|Durability estimates: Freedom from Mitral Valve Surgery/Re-operation|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.||participants|||Number
713473|NCT00209274|Secondary|Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation (MR).||24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.||participants|||Number
713474|NCT00209274|Secondary|Regurgitant Fraction|Regurgitant fraction as determined by the core echo laboratory. Regurgitant fraction is defined as the regurgitant volume divided by the forward stroke volume through the regurgitant valve.|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.||percentage||Standard Deviation|Mean
713475|NCT00209274|Secondary|Regurgitant Volume|Regurgitant volume as determined by the core echo laboratory.|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.||mL||Standard Deviation|Mean
713512|NCT00209339|Secondary|Mitral Valve Gradient|Defined as the mean and peak pressure gradients across the mitral valve as measured by echocardiography.|24 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.||mmHg||95% Confidence Interval|Mean
713476|NCT00209274|Secondary|Number of Participants With Durability of the MitraClip Device and Surgery.|"Device group: Freedom from death, surgery for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval.
Control group: Freedom from death, re-operation for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval."|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.||participants|||Number
713477|NCT00209274|Secondary|Short Form (SF)-36 Quality of Life Questionnaire.|"The SF-36 is a multidimensional, patient-reported survey containing 36 questions on a 0-100 scale measuring physical (Physical Component Score PCS) & mental health status (Mental Component Score MCS) in relation to 8 health concepts: physical functioning, role limitations due to physical or emotional health, bodily pain, general health perceptions, vitality, social functioning, & general mental health. Responses to each of the SF-36 items are scored and expressed as a score on a 0–100 scale (0% in a domain represents the poorest possible QOL&100% indicates full QOL).Higher scores represent better self-perceived health.
The physical & mental functions were assessed by the Physical Component Summary (PCS) score & Mental Component Summary (MCS) score. Normal PCS and MCS scores vary depending on the demographics of the population studied. The PCS&MCS norms for 65-75 year old are 44 & 52, respectively while the norms for CHF population are 31 & 46, respectively."|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.||scores on a scale||Standard Deviation|Mean
713478|NCT00209274|Secondary|Short Form (SF)-36 Quality of Life Questionnaire.|"The SF-36 is a multidimensional, patient-reported survey containing 36 questions on a 0-100 scale measuring physical (Physical Component Score PCS) & mental health status (Mental Component Score MCS) in relation to 8 health concepts: physical functioning, role limitations due to physical or emotional health, bodily pain, general health perceptions, vitality, social functioning, & general mental health. Responses to each of the SF-36 items are scored and expressed as a score on a 0–100 scale (0% in a domain represents the poorest possible QOL&100% indicates full QOL).Higher scores represent better self-perceived health.
The physical & mental functions were assessed by the Physical Component Summary (PCS) score & Mental Component Summary (MCS) score. Normal PCS and MCS scores vary depending on the demographics of the population studied. The PCS&MCS norms for 65-75 year old are 44 & 52, respectively while the norms for CHF population are 31 & 46, respectively."|30 days|"The SF-36 questionnaire consists of 36 questions in relation to eight health concepts:
Physical functioning, role limitations due to physical health, bodily pain,general health perceptions,vitality (energy/fatigue),social functioning,role limitations due to emotional health and general mental health (psychological distress/wellbeing)."||scores on a scale||Standard Deviation|Mean
713479|NCT00209274|Secondary|Number of Participants With Mitral Valve Stenosis|Defined as a mitral valve planimetered orifice area of less than 1.5 cm^2 as measured by echocardiography.|12 months|||Participants|||Count of Participants
713480|NCT00209274|Secondary|Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation.||12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.||participants|||Number
713481|NCT00209274|Secondary|Number of Participants With Incidence of Hospital Readmissions for Congestive Heart Failure (CHF).||30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.||participants|||Number
713482|NCT00209274|Secondary|Number of Participants With Mitral Valve Repair Success.|Defined as freedom from mitral valve replacement surgery for Valve Dysfunction, death, re-operation, and MR > 2+ at 12 months.|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.||participants|||Number
713483|NCT00209274|Secondary|Regurgitant Fraction|Regurgitant fraction as determined by the core echo laboratory. Regurgitant fraction is defined as the regurgitant volume divided by the forward stroke volume through the regurgitant valve.|30 Days|The number of participants analyzed includes subjects who had available follow up data at that time frame.||percentage||Standard Deviation|Mean
713484|NCT00209274|Secondary|Regurgitant Volume|Regurgitant volume as determined by the core echo laboratory. In the presence of regurgitation of one valve, without any intracardiac shunt, the flow through the affected valve is larger than through other competent valves. The difference between the two represents the regurgitant volume.|30 Days|The number of participants analyzed includes subjects who had available follow up data at that time frame.||mL||Standard Deviation|Mean
713485|NCT00209274|Secondary|Number of Participants With Procedural Success|Defined as successful implant of the Clip(s) with resulting MR severity ≤ 2 at discharge or 1 grade MR reduction at discharge accompanied by 1 level NYHA reduction.|30 days|Not applicable for Mitral valve surgery patients as device was not implanted.||participants|||Number
713486|NCT00209274|Secondary|Number of Participants With Acute Procedural Success|Defined as successful MitraClip implantation with resulting MR of 2+ or less.|30 Days|Not applicable for Mitral valve surgery patients as device was not implanted.||participants|||Number
713487|NCT00209274|Secondary|Number of Participants With Acute Surgical Success|Defined as successful mitral valve repair or replacement surgery.|30 Days|Not applicable for Mitral valve surgery patients as device was not implanted.||participants|||Number
713488|NCT00209274|Secondary|Number of Participants With Mitral Valve Stenosis|Defined as a mitral valve planimetered orifice area of less than 1.5 cm^2 as measured by echocardiography.|30 days|||participants|||Number
713489|NCT00209274|Secondary|Number of Participants With Clip Implant Rate|Defined as the rate of successful implantation of MitraClip(s).|Day 0|The number of participants analyzed includes subjects who had available follow up data at that time frame.||participants|||Number
713490|NCT00209274|Primary|Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation (MR).||12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.||participants|||Number
713491|NCT00209274|Primary|Number of Participants With Major Adverse Events (MAE)|Defined as a combined clinical endpoint of death, myocardial infarction, reoperation for failed surgical repair or replacement, nonelective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, gastrointestinal (GI) complication requiring surgery, new onset of permanent atrial fibrillation, septicemia, and transfusion of 2 or more units of blood.|30 days|Per-protocol cohort||participants|||Number
713544|NCT00209339|Secondary|Death (Kaplan-Meier Freedom From Death)||At 12 months|||Percentage of participants||95% Confidence Interval|Number
713492|NCT00209339|Secondary|New York Heart Association (NYHA) Functional Class|"Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status.
Class I: Patients with cardiac disease but without resulting limitations of physical activity.
Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.
Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|60 months|"NYHA functional class was evaluated in 15 patients at the 48-month follow-up visit. NYHA assessment is missing in 40 patients due to:
30 withdrawals
4 deaths
As per the protocol, the 6 patients not implanted with the MitraClip were not required to attend follow-up visits."||participants|||Number
713493|NCT00209339|Secondary|New York Heart Association (NYHA) Functional Class|"Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status.
Class I: Patients with cardiac disease but without resulting limitations of physical activity.
Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.
Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|48 months|"NYHA functional class was evaluated in 19 patients at the 48-month follow-up visit. NYHA assessment is missing in 36 patients due to:
23 withdrawals
3 deaths
1 missed visit
3 NYHA assessments not done
As per the protocol, the 6 patients not implanted with the MitraClip were not required to attend follow-up visits."||participants|||Number
713494|NCT00209339|Secondary|New York Heart Association (NYHA) Functional Class|"Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status.
Class I: Patients with cardiac disease but without resulting limitations of physical activity.
Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.
Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|36 months|"NYHA functional class was evaluated in 21 patients at the 36-month follow-up visit. NYHA assessment is missing in 34 patients due to:
19 withdrawals
2 deaths
3 missed visits
4 NYHA assessments not done
As per the protocol, the 6 patients not implanted with the MitraClip were not required to attend follow-up visits."||participants|||Number
713495|NCT00209339|Secondary|New York Heart Association (NYHA) Functional Class|"Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status.
Class I: Patients with cardiac disease but without resulting limitations of physical activity.
Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.
Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|24 months|"NYHA functional class was evaluated in 28 patients at the 24-month follow-up visit. NYHA assessment is missing in 27 patients due to:
18 withdrawals
2 deaths
1 missed visit
As per the protocol, the 6 patients not implanted with the MitraClip were not required to attend follow-up visits."||participants|||Number
713496|NCT00209339|Secondary|New York Heart Association (NYHA) Functional Class|"Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status.
Class I: Patients with cardiac disease but without resulting limitations of physical activity.
Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.
Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|18 months|"NYHA functional class was evaluated in 27 patients at the 18-month follow-up visit. NYHA assessment is missing in 28 patients due to:
15 withdrawals
2 deaths
5 missed visits
As per the protocol, the 6 patients not implanted with the MitraClip were not required to attend follow-up visits."||participants|||Number
713509|NCT00209339|Secondary|Cardiac Output|Cardiac output as measured by core lab echocardiography. Cardiac output is the product of forward stroke volume and heart rate.|During the hospital stay with a maximum of 3 days post index procedure (Discharge)|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.||L/min||95% Confidence Interval|Mean
713510|NCT00209339|Secondary|Cardiac Output|Cardiac output as measured by core lab echocardiography. Cardiac output is the product of forward stroke volume and heart rate.|Baseline|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.||L/min||95% Confidence Interval|Mean
713511|NCT00209339|Secondary|Mitral Valve Gradient|Defined as the mean and peak pressure gradients across the mitral valve as measured by echocardiography.|60 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.||mmHg||95% Confidence Interval|Mean
713545|NCT00209339|Secondary|Death (Kaplan-Meier Freedom From Death)||Within 30 days of the procedure|||Percentage of participants|||Number
713497|NCT00209339|Secondary|New York Heart Association (NYHA) Functional Class|"Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status.
Class I: Patients with cardiac disease but without resulting limitations of physical activity.
Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.
Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|12 months|"NYHA functional class was evaluated in 39 patients at the 12-month follow-up visit. NYHA assessment is missing in 16 patients due to:
8 withdrawals
1 death
NYHA assessment not done in 1 patient
As per the protocol, the 6 patients not implanted with the MitraClip were not required to attend follow-up visits."||participants|||Number
713498|NCT00209339|Secondary|New York Heart Association (NYHA) Functional Class|"Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status.
Class I: Patients with cardiac disease but without resulting limitations of physical activity.
Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.
Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|30 days|"NYHA functional class was evaluated in 47 patients at the 30-day follow-up visit. NYHA assessment is missing in 8 patients due to:
2 withdrawals
As per the protocol, the 6 patients not implanted with the MitraClip were not required to attend follow-up visits."||participants|||Number
713499|NCT00209339|Secondary|New York Heart Association (NYHA) Functional Class|"Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status.
Class I: Patients with cardiac disease but without resulting limitations of physical activity.
Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.
Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|6 months|"NYHA functional class was evaluated in 41 patients at the 6-month follow-up visit. NYHA assessment is missing in 14 patients due to:
7 withdrawals
1 death
As per the protocol, the 6 patients not implanted with the MitraClip were not required to attend follow-up visits."||participants|||Number
713500|NCT00209339|Secondary|New York Heart Association (NYHA) Functional Class|"Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status.
Class I: Patients with cardiac disease but without resulting limitations of physical activity.
Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.
Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|Baseline|||participants|||Number
713501|NCT00209339|Secondary|Cardiac Index|Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index is measured by core lab echocardiography.|60 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.||L/min/m^2||95% Confidence Interval|Mean
713502|NCT00209339|Secondary|Cardiac Index|Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index is measured by core lab echocardiography.|24 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.||L/min/m^2||95% Confidence Interval|Mean
713503|NCT00209339|Secondary|Cardiac Index|Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index is measured by core lab echocardiography.|12 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.||L/min/m^2||95% Confidence Interval|Mean
713504|NCT00209339|Secondary|Cardiac Index|Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index is measured by core lab echocardiography.|During the hospital stay with a maximum of 3 days post index procedure (Discharge)|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.||L/min/m^2||95% Confidence Interval|Mean
713505|NCT00209339|Secondary|Cardiac Index|Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index is measured by core lab echocardiography.|Baseline|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.||L/min/m^2||95% Confidence Interval|Mean
713506|NCT00209339|Secondary|Cardiac Output|Cardiac output as measured by core lab echocardiography. Cardiac output is the product of forward stroke volume and heart rate.|60 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.||L/min||95% Confidence Interval|Mean
713507|NCT00209339|Secondary|Cardiac Output|Cardiac output as measured by core lab echocardiography. Cardiac output is the product of forward stroke volume and heart rate.|24 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.||L/min||95% Confidence Interval|Mean
713508|NCT00209339|Secondary|Cardiac Output|Cardiac output as measured by core lab echocardiography. Cardiac output is the product of forward stroke volume and heart rate.|12 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.||L/min||95% Confidence Interval|Mean
713513|NCT00209339|Secondary|Mitral Valve Gradient|Defined as the mean and peak pressure gradients across the mitral valve as measured by echocardiography.|12 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.||mmHg||95% Confidence Interval|Mean
713514|NCT00209339|Secondary|Mitral Valve Gradient|Defined as the mean and peak pressure gradients across the mitral valve as measured by echocardiography.|During the hospital stay with a maximum of 3 days post index procedure (Discharge)|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.||mmHg||95% Confidence Interval|Mean
713515|NCT00209339|Secondary|Mitral Valve Gradient|Defined as the mean and peak pressure gradients across the mitral valve as measured by echocardiography.|Baseline|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.||mmHg||95% Confidence Interval|Mean
713516|NCT00209339|Secondary|Mitral Valve Area (MVA) by Pressure Half-Time|"The pressure half time (PHT) measurement for assessing the severity of mitral stenosis is a widely accepted echocardiographic method.
The decline of the velocity of diastolic transmitral blood flow is inversely proportional to mitral valve area (MVA), and MVA is derived using the empirical formula: MVA (cm^2) = 220/PHT PHT is calculated automatically by tracing the deceleration slope of the E-wave of transmitral flow, obtained with continuous wave Doppler echocardiography."|60 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.||cm^2||95% Confidence Interval|Mean
713517|NCT00209339|Secondary|Mitral Valve Area (MVA) by Pressure Half-Time|"The pressure half time (PHT) measurement for assessing the severity of mitral stenosis is a widely accepted echocardiographic method.
The decline of the velocity of diastolic transmitral blood flow is inversely proportional to mitral valve area (MVA), and MVA is derived using the empirical formula: MVA (cm^2) = 220/PHT PHT is calculated automatically by tracing the deceleration slope of the E-wave of transmitral flow, obtained with continuous wave Doppler echocardiography."|24 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.||cm^2||95% Confidence Interval|Mean
713518|NCT00209339|Secondary|Mitral Valve Area (MVA) by Pressure Half-Time|"The pressure half time (PHT) measurement for assessing the severity of mitral stenosis is a widely accepted echocardiographic method.
The decline of the velocity of diastolic transmitral blood flow is inversely proportional to mitral valve area (MVA), and MVA is derived using the empirical formula: MVA (cm^2) = 220/PHT PHT is calculated automatically by tracing the deceleration slope of the E-wave of transmitral flow, obtained with continuous wave Doppler echocardiography."|12 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.||cm^2||95% Confidence Interval|Mean
713519|NCT00209339|Secondary|Mitral Valve Area (MVA) by Pressure Half-Time|"The pressure half time (PHT) measurement for assessing the severity of mitral stenosis is a widely accepted echocardiographic method.
The decline of the velocity of diastolic transmitral blood flow is inversely proportional to mitral valve area (MVA), and MVA is derived using the empirical formula: MVA (cm^2) = 220/PHT
PHT is calculated automatically by tracing the deceleration slope of the E-wave of transmitral flow, obtained with continuous wave Doppler echocardiography."|During the hospital stay with a maximum of 3 days post index procedure (Discharge)|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.||cm^2||95% Confidence Interval|Mean
713520|NCT00209339|Secondary|Mitral Valve Area (MVA) by Pressure Half-Time|"The pressure half time (PHT) measurement for assessing the severity of mitral stenosis is a widely accepted echocardiographic method.
The decline of the velocity of diastolic transmitral blood flow is inversely proportional to mitral valve area (MVA), and MVA is derived using the empirical formula: MVA (cm^2) = 220/PHT PHT is calculated automatically by tracing the deceleration slope of the E-wave of transmitral flow, obtained with continuous wave Doppler echocardiography."|Baseline|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.||cm^2||95% Confidence Interval|Mean
713521|NCT00209339|Secondary|Mitral Valve Area - Single Orifice|Mitral valve area measured by planimetry. Using a cineloop acquired at the mitral valve leaflet tips, the point in diastole corresponding to the maximal opening is identified. The area pre-device as well as post-device are planimetered. Post-device, the mitral valve orifice area is the sum of the area of each of the two orifices.|60 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.||cm^2||95% Confidence Interval|Mean
713522|NCT00209339|Secondary|Mitral Valve Area - Single Orifice|Mitral valve area measured by planimetry. Using a cineloop acquired at the mitral valve leaflet tips, the point in diastole corresponding to the maximal opening is identified. The area pre-device as well as post-device are planimetered. Post-device, the mitral valve orifice area is the sum of the area of each of the two orifices.|24 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.||cm^2||95% Confidence Interval|Mean
713523|NCT00209339|Secondary|Mitral Valve Area - Single Orifice|Mitral valve area measured by planimetry. Using a cineloop acquired at the mitral valve leaflet tips, the point in diastole corresponding to the maximal opening is identified. The area pre-device as well as post-device are planimetered. Post-device, the mitral valve orifice area is the sum of the area of each of the two orifices.|12 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.||cm^2||95% Confidence Interval|Mean
713524|NCT00209339|Secondary|Mitral Valve Area - Single Orifice|Mitral valve area measured by planimetry. Using a cineloop acquired at the mitral valve leaflet tips, the point in diastole corresponding to the maximal opening is identified. The area pre-device as well as post-device are planimetered. Post-device, the mitral valve orifice area is the sum of the area of each of the two orifices.|During the hospital stay with a maximum of 3 days post index procedure (Discharge)|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.||cm^2||95% Confidence Interval|Mean
713525|NCT00209339|Secondary|Mitral Valve Area - Single Orifice|Mitral valve area measured by planimetry. Using a cineloop acquired at the mitral valve leaflet tips, the point in diastole corresponding to the maximal opening is identified. The area pre-device as well as post-device are planimetered. Post-device, the mitral valve orifice area is the sum of the area of each of the two orifices.|Baseline|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.||cm^2||95% Confidence Interval|Mean
713546|NCT00209339|Secondary|Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery)|Freedom from mitral valve surgery required to treat mitral regurgitation and/or mitral stenosis and/or for Cardiac Surgery for Failed Clip following the MitraClip device procedure.|At 5 Years|||Percentage of participants||95% Confidence Interval|Number
713526|NCT00209339|Secondary|Left Ventricular End Systolic Volume|Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.|60 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.||Milliliter||95% Confidence Interval|Mean
713527|NCT00209339|Secondary|Left Ventricular End Systolic Volume|Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.|24 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.||Milliliter||95% Confidence Interval|Mean
713528|NCT00209339|Secondary|Left Ventricular End Systolic Volume|Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.|12 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.||Milliliter||95% Confidence Interval|Mean
713529|NCT00209339|Secondary|Left Ventricular End Systolic Volume|Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.|During the hospital stay with a maximum of 3 days post index procedure (Discharge)|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.||Milliliter||95% Confidence Interval|Mean
713530|NCT00209339|Secondary|Left Ventricular End Systolic Volume|Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.|Baseline|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.||Milliliter||95% Confidence Interval|Mean
713531|NCT00209339|Secondary|Left Ventricular End Diastolic Volume|Left Ventricular end-diastolic volume (LVEDV) as determined by the core echo laboratory. Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.|60 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.||Milliliter||95% Confidence Interval|Mean
713532|NCT00209339|Secondary|Left Ventricular End Diastolic Volume|Left Ventricular end-diastolic volume (LVEDV) as determined by the core echo laboratory. Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.|24 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.||Milliliter||95% Confidence Interval|Mean
713533|NCT00209339|Secondary|Left Ventricular End Diastolic Volume|Left Ventricular end-diastolic volume (LVEDV) as determined by the core echo laboratory. Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.|12 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.||Milliliter||95% Confidence Interval|Mean
713534|NCT00209339|Secondary|Left Ventricular End Diastolic Volume|Left Ventricular end-diastolic volume (LVEDV) as determined by the core echo laboratory. Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.|During the hospital stay with a maximum of 3 days post index procedure (Discharge)|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.||Milliliter||95% Confidence Interval|Mean
713535|NCT00209339|Secondary|Left Ventricular End Diastolic Volume|Left Ventricular end-diastolic volume (LVEDV) as determined by the core echo laboratory. Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.|Baseline|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.||Milliliter||95% Confidence Interval|Mean
713536|NCT00209339|Secondary|Other Secondary Safety Events|Other safety event includes Endocarditis, MitraClip DeviceThrombosis, Hemolysis, Mitral Valve Injury (major).|Through 6 months|||percentage of participants|||Number
713537|NCT00209339|Secondary|Other Secondary Safety Events|Other safety event includes Endocarditis, MitraClip DeviceThrombosis, Hemolysis, Mitral Valve Injury (major).|Through 30 days|||percentage of participants|||Number
713538|NCT00209339|Secondary|Major Vascular and Bleeding Complications|Major bleeding complications is defined as transfusion of >=2 units of blood due to bleeding related to the index procedure|Through 6 Months|||percentage of participants|||Number
713539|NCT00209339|Secondary|Major Vascular and Bleeding Complications|Major bleeding complications is defined as transfusion of >=2 units of blood due to bleeding related to the index procedure|Through 30 days|||percentage of participants|||Number
713540|NCT00209339|Secondary|Death (Kaplan-Meier Freedom From Death)||At 5 years|||Percentage of participants||95% Confidence Interval|Number
713541|NCT00209339|Secondary|Death (Kaplan-Meier Freedom From Death)||At 4 years|||Percentage of participants||95% Confidence Interval|Number
713542|NCT00209339|Secondary|Death (Kaplan-Meier Freedom From Death)||At 3 years|||Percentage of participants||95% Confidence Interval|Number
713543|NCT00209339|Secondary|Death (Kaplan-Meier Freedom From Death)||At 24 months|||Percentage of participants||95% Confidence Interval|Number
713547|NCT00209339|Secondary|Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery)|Freedom from mitral valve surgery required to treat mitral regurgitation and/or mitral stenosis and/or for Cardiac Surgery for Failed Clip following the MitraClip device procedure.|At 4 Years|||Percentage of participants||95% Confidence Interval|Number
713548|NCT00209339|Secondary|Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery)|Freedom from mitral valve surgery required to treat mitral regurgitation and/or mitral stenosis and/or for Cardiac Surgery for Failed Clip following the MitraClip device procedure.|At 3 Years|||Percentage of participants||95% Confidence Interval|Number
713549|NCT00209339|Secondary|Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery)|Freedom from mitral valve surgery required to treat mitral regurgitation and/or mitral stenosis and/or for Cardiac Surgery for Failed Clip following the MitraClip device procedure.|At 24 months|||Percentage of participants||95% Confidence Interval|Number
713550|NCT00209339|Secondary|Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery)|Freedom from mitral valve surgery required to treat mitral regurgitation and/or mitral stenosis and/or for Cardiac Surgery for Failed Clip following the MitraClip device procedure.|At 12 months|||Percentage of participants||95% Confidence Interval|Number
713551|NCT00209339|Secondary|Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery)|Freedom from mitral valve surgery required to treat mitral regurgitation and/or mitral stenosis and/or for Cardiac Surgery for Failed Clip following the MitraClip device procedure.|At baseline|||Percentage of participants|||Number
713552|NCT00209339|Secondary|MitraClip Device Embolizations and Single Leaflet Device Attachment|MitraClip device embolizations means the detachment from both mitral leaflets. Single Leaflet Device Attachment (SLDA) is defined as the attachment of a single leaflet to the MitraClip device.|Post index procedure through 5 years|Of the 55 patients enrolled in the EVEREST I study, 6 patients did not have a MitraClip device implanted.||Participants|||Number
713553|NCT00209339|Secondary|Second Intervention to Place a Second MitraClip Device||Post index procedure through 5 years|||Participants|||Number
713554|NCT00209339|Secondary|Post-procedure Hospital Stay||Post-index procedure until hospital discharge (1 to 19 days)|||Days||Standard Deviation|Mean
713555|NCT00209339|Secondary|Post-procedure Intensive Care Unit (ICU)/Critical Care Unit (CCU)/Post-anesthesia Care Unit (PACU) Duration||Post index procedure within 30 days|||Hours||Standard Deviation|Mean
713556|NCT00209339|Secondary|Intra-procedural Major Adverse Events|Significant intra-procedural Major adverse events are defined as Major Adverse Events that occurred on the day of the procedure|At day 0 (on the day of index procedure)|||percentage of participants|||Number
713557|NCT00209339|Secondary|Number of Mitraclip Devices Implanted||At day 0 (on the day of index procedure)|||Percentage of participants|||Number
713558|NCT00209339|Secondary|Fluoroscopy Duration|Mean fluoroscopy duration during the MitraClip procedure.|At day 0 (on the day of index procedure)|Mean fluoroscopy duration was not recorded in one patient. Therefore, mean fluoroscopy data is available for 54 of the 55 patients.||Minutes||Standard Deviation|Mean
713559|NCT00209339|Secondary|Contrast Volume|Mean contrast volume utilized during the MitraClip procedure.|At day 0 (on the day of index procedure)|Contrast volume was not recorded in one patient. Therefore, contrast volume data is available for 54 of the 55 patients.||Milliliters||Standard Deviation|Mean
713560|NCT00209339|Secondary|Device Time|Device Time, defined as the time of insertion of the Steerable Guide Catheter (SGC) to the time the MitraClip Delivery Catheter is retracted into the SGC.|At day 0 (on the day of index procedure)|||Minutes||Standard Deviation|Mean
713561|NCT00209339|Secondary|Procedure Time|"Procedure Time, defined as the time of start of the transseptal procedure to the time the Steerable Guide Catheter (SOC) is removed, averaged 255 minutes, or just over 4 hours.
The reported Procedure Time includes the time required to collect Protocol required hemodynamic data pre- and post-implantation of the MitraClip device."|At day 0 (on the day of index procedure)|||Minutes||Standard Deviation|Mean
713562|NCT00209339|Primary|Major Adverse Events (MAE)|Defined in the Protocol as a combined clinical endpoint of death, myocardial infarction, cardiac tamponade, cardiac surgery for failed MitraClip device, single leaflet device attachment, stroke and septicemia.|Through 6 Months|||Percentage of participants|||Number
713563|NCT00209339|Primary|Major Adverse Events (MAE)|Defined in the Protocol as a combined clinical endpoint of death, myocardial infarction, cardiac tamponade, cardiac surgery for failed MitraClip device, single leaflet device attachment, stroke and septicemia.|Through 30 days|||Percentage of participants|||Number
713564|NCT00209339|Primary|Mitral Regurgitation Severity|All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL).|At 5 years|Of total 55 patients population 15 patients were analysed, as 40 patients were withdrawn or lost to follow-up.||Percentage of participants|||Number
713565|NCT00209339|Primary|Mitral Regurgitation Severity|All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL).|At 4 years|Of total 55 patients population 19 patients were analysed, as for 4 patients Echocardiogram was not performed and 32 patients were withdrawn or lost to follow-up.||Percentage of participants|||Number
713566|NCT00209339|Primary|Mitral Regurgitation Severity|All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL).|At 3 years|Of total 55 patients population 23 patients were analysed, as for 5 patients Echocardiogram was not performed and 27 patients were withdrawn or lost to follow-up.||Percentage of participants|||Number
713877|NCT00224055|Primary|Change in Hemoglobin (Hgb)|Change from baseline to 7 weeks after 4 consecutive weekly Ferrlecit 250 mg intravenious infusion and change from baseline to 4 weeks after 6 weeks oral ferrous sulfate 325 mg tablets t.i.d.|Baseline to 10 weeks|Modified ITT with LOCF imputation||g/dL||Standard Deviation|Mean
713567|NCT00209339|Primary|Mitral Regurgitation Severity|All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL).|At 24 months|Of total 55 patients population 28 patients were analysed, as for 1 patient Echocardiogram was not performed and 15 patients were withdrawn or lost to follow-up.||Percentage of participants|||Number
713568|NCT00209339|Primary|Mitral Regurgitation Severity|All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL).|At 12 months|Of total 55 patients population 39 patients were analyzed, as for 1 patient Echocardiogram was not performed and 15 patients were withdrawn or lost to follow-up.||Percentage of participants|||Number
713569|NCT00209339|Primary|Mitral Regurgitation Severity|All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL).|At discharge or within 30 days of the procedure|Based on the number of patients who have not died or withdrawn, and have reached the scheduled visit window||Percentage of participants|||Number
713570|NCT00209339|Primary|Mitral Regurgitation Severity|All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL).|At baseline|Of total 55 patients,for 1 patient Echocardiogram was not evaluable.||Percentage of participants|||Number
713571|NCT00215540|Secondary|Days in Hospital|The number of days spent in the hospital through 36 weeks PMA|36 weeks PMA|A sample size of 70 per arm is sufficient to demonstrate a 20% relative risk reduction. All randomized infants were analyzed (intent-to-treat)||days||Standard Deviation|Mean
713572|NCT00215540|Secondary|Incidence of Death or BPD at 28 Days|Death or BPD, defined as oxygen requirement at 28 days of life|28 days of life|A sample size of 70 per arm is sufficient to demonstrate a 20% relative risk reduction. All randomized infants were analyzed (intent-to-treat)||participants|||Number
713573|NCT00215540|Secondary|Area Under the Curve for Mean Arterial Pressure (MAP)|AUC for MAP (in mm Hg) calculated using the trapezoidal rule. Missing data imputed using last observation carried forward|15 minutes prior to dose 1, 2 hours post dose 1, 6 hours post dose 1, 24 hours post dose 1, and daily from Study Day 2 to Study Day 25, and day of life 28|A sample size of 70 per arm is sufficient to demonstrate a 20% relative risk reduction. All randomized infants were analyzed (intent-to-treat)||arterial pressure (mm Hg)*hour||Standard Deviation|Mean
713574|NCT00215540|Secondary|Area Under the Curve for Fraction of Inspired Oxygen (FiO₂)|AUC for FiO₂calculated using the trapezoidal rule. Missing data imputed using last observation carried forward|15 minutes prior to dose 1, 2 hours post dose 1, 6 hours post dose 1, 24 hours post dose 1, and daily from Study Day 2 to Study Day 25 and Day of Life 28|A sample size of 70 per arm is sufficient to demonstrate a 20% relative risk reduction. All randomized infants were analyzed (intent-to-treat)||Percent O₂*hour||Standard Deviation|Mean
713575|NCT00215540|Secondary|Duration of Supplemental Oxygen|Number of days receiving supplemental oxygen through 36 weeks PMA|36 weeks PMA|A sample size of 70 per arm is sufficient to demonstrate a 20% relative risk reduction. All randomized infants were analyzed (intent-to-treat)||days||Standard Deviation|Mean
713576|NCT00215540|Secondary|Days Receiving Mechanical Ventilation (MV)|Number of days receiving mechanical ventilation|36 weeks PMA|A sample size of 70 per arm is sufficient to demonstrate a 20% relative risk reduction. All randomized infants were analyzed (intent-to-treat)||days||Standard Deviation|Mean
713577|NCT00215540|Secondary|BPD at 36 Weeks|BPD at 36 weeks PMA as determined by the need for supplemental oxygen|36 weeks PMA|A sample size of 70 per arm is sufficient to demonstrate a 20% relative risk reduction. All randomized infants were analyzed (intent-to-treat)||participants|||Number
713578|NCT00215540|Secondary|BPD at 28 Days|BPD at 28 days of life, as determined by the need for supplemental oxygen|28 days of life|A sample size of 70 per arm is sufficient to demonstrate a 20% relative risk reduction. All randomized infants were analyzed (intent-to-treat)||participants|||Number
713579|NCT00215540|Primary|All-cause Mortality||36 weeks PMA|A sample size of 70 per arm is sufficient to demonstrate a 20% relative risk reduction. All randomized infants were analyzed (intent-to-treat)||participants|||Number
713580|NCT00215540|Primary|Incidence of Death or Bronchopulmonary Dysplasia (BPD) at 36 Weeks|Number of participants who died or developed BPD, defined as oxygen requirement at 36 Weeks post-menstrual age|36 weeks post-menstrual age (PMA)|A sample size of 70 per arm is sufficient to demonstrate a 20% relative risk reduction. All randomized infants were analyzed (intent-to-treat)||participants|||Number
713581|NCT00215553|Secondary|Days in ICU|Number of days in ICU|Day 28|"In Part A, 5 subjects provided a reasonable cohort to adequately examine the safety of each treatment regimen.
In Part B, 30 subjects were planned to be enrolled in each treatment group (a total of 90 subjects), enough to calculate the dose response curve.
Analyses conducted on Intent-to-Treat population (all enrolled subjects)."||days||Standard Deviation|Mean
713582|NCT00215553|Secondary|Mortality||Day 28|"In Part A, 5 subjects provided a reasonable cohort to adequately examine the safety of each treatment regimen.
In Part B, 30 subjects were planned to be enrolled in each treatment group (a total of 90 subjects), enough to calculate the dose response curve.
Analyses conducted on Intent-to-Treat population (all enrolled subjects)."||participants|||Number
713583|NCT00215553|Primary|Incidence of Patients Being Alive and Not Receiving Mechanical Ventilation for ≥48 Hours at the End of Day 28.||28 days|"In Part A, 5 subjects provided a reasonable cohort to adequately examine the safety of each treatment regimen.
In Part B, 30 subjects were planned to be enrolled in each treatment group (a total of 90 subjects), enough to calculate the dose response curve.
Analyses conducted on Intent-to-Treat population (all enrolled subjects)."||participants|||Number
713878|NCT00224107|Secondary|Maximum Urine Flow Rate (Qmax)|Change from baseline in maximum urine flow rate (Qmax)at Week 12|12 weeks|The number of participants for analysis is determined by Last Observation Carried Forward (LOCF).||mL/sec||Standard Deviation|Mean
713584|NCT00215657|Primary|Participants With Markedly Abnormal Change in Vital Signs and Body Weight|Vital signs and body weight included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of patients in each group with normal baseline and markedly abnormal value post-baseline.|3 years|These data include patients from the main study (FE200486 CS07) and the extension study (FE200486 CS07A).||participants|||Number
713585|NCT00215657|Primary|Liver Function Tests|The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases >3x ULN and ALT increases >3x ULN with concurrently increased bilirubin >1.5 ULN.|3 years|The data include patients from both the main study (FE200486 CS07) and the extension study FE200486 CS07A||participants|||Number
713586|NCT00215683|Primary|Liver Function Tests|The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases >3x ULN and ALT increases >3x ULN with concurrently increased bilirubin >1.5 ULN.|5 years|The data include data from participants participating in both the main study (FE200486 CS12) and the extension study FE200486 CS12A.||participants|||Number
713587|NCT00215683|Primary|Participants With Markedly Abnormal Change in Vital Signs and Body Weight|Vital signs and body weight included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of participants in each group with normal baseline and markedly abnormal value post-baseline.|5 years|The data include data from participants participating in both the main study (FE200486 CS12) and the extension study FE200486 CS12A.||participants|||Number
713588|NCT00216060|Secondary|Bone Turnover Marker Changes-- Serum Osteocalcin (OC)|Serum Osteocalcin (OC) medians between baseline and 24 weeks areperformed with the Elecsys 2010 automated analyzer, which uses an electrochemiluminescence immunoassay technique for the in vitro quantitative determination of serum total osteocalcin in humanserum. The assay uses a sandwich test principle in which afirst biotinylated monoclonal antibody recognizing N-MID osteocalcin and a second monoclonal antibody against N-MID osteocalcin labeled with ruthenium are incubated with 20mL of serum. After a first incubation, streptavidin-coated microparticles are added for a second incubation, and the complex becomes bound to the solid phase by interaction of biotin and streptavidin.These microparticles are then magnetically captured onto the surface of an electrode. Application of a voltage on this electrode induces chemiluminescent emission, which is measured by a photomultiplierand compared with a calibration curve that is generated in aninstrument-specific manner by 2-point calibration.|24 week|Number of Participants Analyzed reflects participants who had data available prior to study termination.||ug/L||Standard Deviation|Median
713589|NCT00216060|Secondary|Bone Turnover Marker Changes-- Serum BAP|Serum BAP median changes between baseline and week 24. The Ostase assays are performed with an access immunoassay system, which is an assay of serum samples that provides a quantitative measurement of bone alkaline phosphatase (BAP). A mouse monoclonal antibody specific to BAP is added to a re-action vessel with paramagnetic particles coated with goat antimouse polyclonalantibody.Calibrators,controls,andsamplescontainingBAP are added to the coated particles and bind to the anti-BAP monoclonal antibody. After the formation of a solid phase/capture antibody/BAP complex, separation in a magnetic field and washing remove materials not bound to the solid phase. A chemiluminescent substrate, LumiPhos 530, is added to the reaction vessel, and light generated by the reaction is measured with a luminometer. The light production is directly proportional to the concentration of BAP in the sample. The amount of analyte in thesample is determined from a stored multipoint calibration curve|24 week|Number of Participants Analyzed reflects participants who had data available prior to study termination.||ng/mL||Standard Deviation|Median
713590|NCT00216060|Secondary|Bone Turnover Marker Changes-- Urine N-telopeptide (NTX) Median|"Urine N-telopeptide (NTX) median changes between baseline and week 24. The assays are performed with the NTx Reagent Pack kit from Ortho-Clinical Diagnostics (Ortho-Clinical Diagnostics/Johnson & Johnson, Amersham, UK), which is a kit designed for the quantitative determination of N-terminal telopeptide (NTx) in human urine on the automated Vitros Immunodiagnostic System ECi (Ortho-Clinical Diagnostics/Johnson & Johnson, Amersham, UK). A competitive immunoassay technique is used. This depends on competition between NTx present in the sample and a synthetic NTx peptide coated on the wells for binding by a horseradish peroxidase (HRP)-labeled antibody conjugate (mouse monoclonal anti-NTx). The conjugate is captured by the peptide coated on the wells; unbound materials are removed by washing.
The bound HRP conjugate is measured by a luminescent reaction."|24 week|Number of Participants Analyzed reflects participants who had data available prior to study termination.||nmol BCE/mmol creatinine||Standard Deviation|Median
713591|NCT00216060|Secondary|Three- Year Survival Rate||36 months|||percentage of participants||95% Confidence Interval|Number
713592|NCT00216060|Secondary|Bone Turnover Marker Changes -- Urine Total Deoxypyridinoline (DPD)|"Urine total DPD median in response to treatment on both study arms at week 24. compare median from baseline and week 24.
Deoxypyridinoline (DPD) is measured in hydrolyzed urine samples using high-performance liquid chromatography technique. After extraction of the cross-links and elimination of the urine impurities by a Bio-Rad SPE cartridge (Bio-Rad Laboratories, Hercules, CA), total DPD is eluted from reverse-phase high-performance liquid chromatography by ion pair chromatography with isocratic elution.
The compounds are detected as a result of their natural fluorescence with a fluorescence detector"|24 weeks|Number of Participants Analyzed reflects participants who had data available prior to study termination.||nmol/mmol creatinine||Standard Deviation|Median
713593|NCT00216060|Secondary|Time to Development of Hormone Refractory Disease||36 months|No data were collected for this Outcome Measure due to low accrual and subsequent study termination.|||||
713594|NCT00216060|Secondary|Rate of Patients Archiving a PSA (Prostate Specific Antigen) Nadir < 0.2 ng/mL||36 months|||percentage of participants|||Number
713595|NCT00216060|Primary|Numbers of SRE or Death Occurred Cumulatively|Number of participants experiencing a SRE(skeletal-related event) or death occurred, cumulative from each arm ( a daily oral dose of 30 mg risedronate, or placebo)|36 months|||participants|||Number
713596|NCT00216086|Secondary|Disease-Free Survival|The three year rate of Disease-Free Survival|36 months|||percentage||95% Confidence Interval|Number
713597|NCT00216086|Secondary|Rate of Clinical Response|To determine the rate of clinical response following induction chemotherapy with capecitabine and irinotecan, and also the overall clinical response after the completion of chemoradiation with capecitabine.|36 months|Data for this secondary objective was not captured or analyzed due to the withdrawal of funding and subsequent termination of the study.|||||
713598|NCT00216086|Secondary|Local and Distant Disease Recurrence Rates|To determine the rates of local and distant disease recurrence after treatment.|36 months|||percentage of particpants|||Number
713599|NCT00216086|Primary|Pathological Complete Response (pCR) Rate|"· To determine the pathological response rate of preoperative chemotherapy with capecitabine and irinotecan followed by combined modality chemoradiation with capecitabine in patients with locally advanced rectal cancer.
Pathological response was defined in the protocol as the proportion of complete (pCR) and non-complete pathological response (pNCR) among all evaluable patients."|36 months|||percentage of patients||95% Confidence Interval|Number
713600|NCT00216099|Secondary|Time to Prostate-Specific Antigen (PSA)/Serological Progression|Serological Progression (sPD) – increase in PSA to >50% above lowest level recorded on study. Two consecutive increases required at least 4 weeks apart, but time to progression will be determined at time of first PSA showing increase > 50% above baseline|From study enrollment to progression per PSA criteria (for life)|||months||95% Confidence Interval|Median
713601|NCT00216099|Secondary|Time to Progression|Progression per Response Evaluation Criteria in Solid Tumors (RECIST) or Prostate-Specific Antigen (PSA) Progression RECIST PD=at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions PSA progression=increase in PSA to >50% above lowest level recorded on study. Two consecutive increases required at least 4 weeks apart, but time to progression will be determined at time of first PSA showing increase > 50% above baseline *Note, upper confidence interval was not reached*|Study enrollment until progression per RECIST or PSA (for life)|||months||95% Confidence Interval|Median
713602|NCT00216099|Secondary|RFC1 G80A Genotype|Samples for RFC1 G80A pharmacogenetic analysis were collected at screening|Screening|Samples were available from 46 patients||participants|||Number
713603|NCT00216099|Secondary|Safety and Tolerability|Safety and Tolerability was evaluated by reporting the percentage of patient who experienced grade 3 or 4 toxicities using Common Terminology Criteria for Adverse Events CTCAE v3.0 criteria. CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.|18 months|||percentage of participants||95% Confidence Interval|Number
713604|NCT00216099|Secondary|Rate of Clinical Benefit|"A clinical benefit is defined as an improvement for at least 3 consecutive weeks in at least one of the following parameters without any sustained worsening in any other:
> 50% reduction in analgesic consumption or > 50% reduction in pain intensity or > 20 point gain in performance status."|Any time among evaluable subjects (for life)|||percentage of participants||95% Confidence Interval|Number
713605|NCT00216099|Secondary|OBJECTIVE Overall Response Rate|"Response Evaluation Criteria in Solid Tumors (RECIST). Objective overall response rate is defined as Complete Response (CR) + Partial Response (PR)
Per RECIST:
CR= Disappearance of all target and non-target lesions and normalization of tumor marker level PR= Disappearance of all target lesions and persistence of non-target lesion(s) or maintenance of tumor marker level above normal limits OR at least a 30% decrease in the sum of the longest diameter, taking as reference the baseline sum longest diameter and disappearance of all non-target lesions or persistence of non-target lesion(s) or maintenance of tumor marker level above normal limits"|Start of treatment until disease progression/recurrence (for life)|Patients who had measurable disease per RECIST 1.1 at baseline. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension with longest diameter >20 mm using conventional techniques or >10 mm with spiral CT scan.||percentage of participants||95% Confidence Interval|Number
713606|NCT00216099|Secondary|Overall Survival||From study enrollment until death (for life)|||months||95% Confidence Interval|Median
713607|NCT00216099|Primary|Best Overall PSA Response|"Best overall Prostate-Specific Antigen (PSA) response
PSA response is defined by a greater than or equal to 50% decline in PSA confirmed by a second PSA value at least 4 weeks after the first PSA response timepoint PSA Stable Disease is defined as less than a 50% decline in PSA and less than a 50% increase in PSA from baseline PSA progression is defined as greater than or equal to a 50% increase in PSA compared to baseline"|Start of treatment until disease progression/recurrence (for life)|||percentage of participatns||95% Confidence Interval|Number
713608|NCT00216125|Secondary|Progression Free Survival|"A comparison of progression free survival following cisplatin/etoposide/radiotherapy between the consolidation docetaxel and observation arms was analyzed using Kaplan-Meier analysis. Median PFS time and a log rank test were used to analyze the hypothesized improvement in progression free survival.
Progression is defined by RECIST as a 20% increase in the sum of longest diameters of target measurable lesions over the smallest sum observed (over baseline if no decrease during therapy) or by the appearance of a new lesion."|Participants were monitored from treatment initiation until disease progression per RECIST or death|||months||95% Confidence Interval|Median
713609|NCT00216125|Primary|Overall Survival|A comparison of overall survival following cisplatin/etoposide/radiotherapy between the consolidation docetaxel and observation arms was analyzed using Kaplan-Meier analysis. Median survival time and a log rank test were used to analyze the hypothesized improvement in overall survival.|Participants were measured from treatment initiation to death|The analysis cohort for the results reported below are based on a planned interim DSMB evaluation conducted in 2006. This evaluation concluded that further accrual was futile and the study should be terminated. The 203 subjects included in this analysis had data sufficiently mature at the time of the DSMB analysis.||Months||95% Confidence Interval|Median
713610|NCT00216203|Secondary|Clinical Benefit Rate|Clinical Benefit Rate (CR + PR + SD lasting more than 90 days)|12 months|Data was not collected or analyzed for this secondary objective.|||||
713611|NCT00216203|Secondary|Toxicity and Safety Profile||12 months|||percentage of particpants|||Number
713612|NCT00216203|Secondary|Median Survival Time||24 Months|27 participants had data sufficient to complete Median Survival Time analysis||weeks||95% Confidence Interval|Median
714983|NCT00247273|Secondary|Change From Baseline in Serum Bone-specific Alkaline Phosphatase (BAP) at Month 6, ITT Population|ug / L = micrograms per liter, Assayed by ELISA (enzyme-linked immunosorbent assay)|Baseline to Month 6|ITT||ug / L||95% Confidence Interval|Least Squares Mean
713613|NCT00216203|Primary|Time To Progression (TTP)|The primary objective of the phase II portion is to estimate the time to progression of this combination, evaluated per RECIST criteria where PD= at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions|24 Months|27 participants had enough data to complete TTP analysis||Weeks||95% Confidence Interval|Median
713614|NCT00216203|Primary|Maximum Tolerated Dose (MTD) of Pemetrexed in Combination With Cetuximab|The primary objective of the phase I portion of this study is to define the maximum tolerated dose (MTD) of the combination of pemetrexed and cetuximab|12 months|12 participants participated in the phase I portion of the trial.||mg/m^2 every 21 days|||Number
713615|NCT00216320|Primary|10 Meter Walking Speed Before and After Intervention.|Subjects walked 10 meters at their fastest safe speed. This was measured under two conditions: On condition - the WA turned on or the AFO worn by the subject; off condition - The WA turned off or the AFO not worn by the subject. The endpoints were analyzed at 6, and 12 weeks|baseline, 6, 6.2 and 12 weeks|||meters/second||Standard Deviation|Mean
713616|NCT00216320|Primary|Physiological Cost Index Before and After Intervention.|PCI is the difference between resting heart rate and active heart rate during walking, divided by average walking speed. This was measured under two conditions: On condition - the WA turned on or the AFO worn by the subject; off condition - The WA turned off or the AFO not worn by the subject. The endpoints were analyzed at 6, and 12 weeks|baseline, 6, 6.2 and 12 weeks|||beats/minute||Standard Deviation|Mean
713617|NCT00216320|Primary|Figure 8 Walking Speed Before and After Intervention.|Subjects walked a 10 meter Figure 8 pattern for four minutes at fastest safe speed. This was measured under two conditions: On condition - the WA turned on or the AFO worn by the subject; off condition - The WA turned off or the AFO not worn by the subject. The endpoints were analyzed at 6, and 12 weeks|baseline, 6, 6.2 and 12 weeks|||meters/second||Standard Deviation|Mean
713618|NCT00216320|Secondary|Number of Subjects Who Preferred Use of WalkAide Over the Use of AFO|Subjects in Arm 1 or 2 (who used both devices) were given the option to continue using WalkAide or AFO for additional 12 weeks, their preference was recorded along with reasons for preference|12 weeks|per protocol (completers) analysis||participants|||Number
713619|NCT00216476|Secondary|Change From Baseline to Endpoint in Short-Form Health Survey 12 (SF-12) Scores|Quality of life was assessed by means of the 12-item SF-12® survey. Two parameters, i.e., PCS (physical component summary) and MCS (mental component summary) were calculated. Both components scores range from 0 to 100 with higher scores indicating better QOL.|Assessed at the moment the subject was randomized to a treatment arm (baseline visit) and after 1, 3, 6, 12, 18, and 24 months of treatment|Efficacy analysis set, defined as all subjects who received at least 1 dose of study medication and had at least 1 efficacy assessment after baseline. This excluded 2 subjects of the risperidone LAI, 11 of the quetipaine, and 1 of the aripiprazole arm. An additional 32, 32, and 2 subjects in the respective arms did not have SF-12 data.||units on a scale||Standard Deviation|Mean
713620|NCT00216476|Secondary|Change From Baseline to Endpoint in Clinical Global Impression Scale (CGI) Score|The 7-point CGI scale of Severity (CGI-S) was used to assess the severity of a subject’s psychotic condition (0= normal, not at all ill, 1= borderline, etc. and 6= among the most extremely ill subjects).|Assessed at each visit from the moment the subject was randomized to a treatment arm (baseline visit) until the end of treatment (Month 24 or earlier)|Efficacy analysis set, defined as all subjects who received at least 1 dose of study medication and had at least 1 efficacy assessment after baseline. This excluded 2 subjects of the risperidone LAI arm, 11 of the quetipaine arm, and 1 of the aripiprazole arm. One additional subject in the risperidone LAI arm did not have CGI data.||units on a scale||Standard Deviation|Mean
713621|NCT00216476|Secondary|Change From Baseline to Endpoint in Total Positive and Negative Syndrome Scale (PANSS) Score|"The neuropsychiatric symptoms of schizophrenia were assessed by means of the 30-item PANSS scale. The PANSS scale provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, i.e., the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items).
Each item of the scale is to be scored on a scale of 1 (absent) to 7 (extreme)."|Assessed at each visit from the moment the subject was randomized to a treatment arm (baseline visit) until the end of treatment (Week 104 or earlier)|Efficacy analysis set, defined as all subjects who received at least 1 dose of study medication and had at least 1 efficacy assessment after baseline. This excluded 2 subjects of the risperidone LAI, 11 of the quetipaine, and 1 of the aripiprazole arm. One additional subject in each the risperidone LAI and quetiapine arm did not have PANSS data.||units on a scale||Standard Deviation|Mean
713622|NCT00216476|Secondary|Mean Relapse Free Period (Exploratory/Aripiprazole)|As for risperidone and quetiapine, relapse was defined as meeting any of the predefined criteria (adapted from Csernansky et al., 2002) on 2 consecutive evaluations during treatment, 3 to 5 days apart. Since aripiprazole was new on the market at the time the study was conducted, this aripiprazole analysis was exploratory.|Assessed at each visit from the moment the subject was randomized to a treatment arm (baseline visit) until the end of treatment (Week 104 or earlier)|Efficacy analysis set, defined as all subjects who received at least 1 dose of study medication and who had at least 1 efficacy assessment after baseline. This excluded 1 subject of the aripiprazole arm.||days||Standard Error|Mean
713623|NCT00216476|Primary|Mean Relapse Free Period(Risperidone LAI Versus Quetiapine)|Relapse was defined as meeting any of the predefined criteria (adapted from Csernansky et al., 2002) on 2 consecutive evaluations during treatment, 3 to 5 days apart. The relapse rate in each treatment arm was estimated using the Kaplan-Meier method.|Assessed at each visit from the moment the subject was randomized to a treatment arm (baseline visit) until the end of treatment (Week 104 or earlier)|Efficacy analysis set, defined as all subjects who received at least 1 dose of study medication and who had at least 1 efficacy assessment after baseline. This excluded 2 subjects of the risperidone LAI arm and 11 of the quetiapine arm.||days||Standard Deviation|Mean
713638|NCT00217087|Primary|Level of Dysplasia on Histology at 12 Months|All specimens were reviewed by two expert GI pathologists for presence of and/or level of dysplasia in Barrett's Esophagus|12 months post therapy|4 participants in the photodynamic therapy group completed at least 3 but less than 12 months follow up post therapy, so they were not included in this analysis.||paricipants|||Number
713879|NCT00224107|Primary|International Prostate Symptom Score (IPSS)|Change from baseline In IPSS at Week 12. IPSS uses a 0 to 35 scale; 0 best, 35 worse symptoms|12 weeks|The number of participants for analysis is determined by Last Observation Carried Forward (LOCF).||Units on a 0 to 35 scale||Standard Deviation|Mean
713624|NCT00216671|Secondary|Change From Baseline to Endpoint in Quality of Life Questionnaire SF-12|Short Form Health Survey: A generic dual–ie, mental and physical health–scale measure of quality of life. This is a 12-item subset of the SF-36 survey that measures the same 8 domains of health. As a brief, reliable measure of overall health status, the SF-12 is the instrument of choice in large population health surveys and has been used extensively as a screening tool. SF-12 will be filled in by the patient. The scores range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.|at baseline, Weeks 6, 12, and endpoint (week 26 or at premature discontinuation).|Per protocol population. This excluded 42 patients in the early start group and 34 patients in the late start group.An additional 9 and 11 patients in the respective groups had missing SF-12 data.||scores on a scale||Standard Deviation|Mean
713625|NCT00216671|Secondary|Change From Baseline to Endpoint in Global Assessment of Functioning (GAF)|Overall psychological, social, and occupational functioning is rated on a scale of mental health-illness from 1 being the worst functioning to 100 being the best. Impairment in functioning due to physical (or environmental) limitations must not be included in the rating.|at baseline and endpoint (week 26 or at premature discontinuation).|Per protocol population. This excluded 42 patients in the early start group and 34 patients in the late start group.One additional patient in the Early Initation group has missing GAF data.||scores on a scale||Standard Deviation|Mean
713626|NCT00216671|Secondary|Change From Baseline to Endpoint in Clinical Global Impression – Severity (CGI-S)|The CGI-S rating scale is used to rate the severity of a subject’s psychotic condition on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe). This scale permits a global evaluation of the subject’s condition at a given time.|at baseline and endpoint (week 26 or at premature discontinuation).|Per protocol population. This excluded 42 patients in the early start group and 34 patients in the late start group.One additional patient in the Early Initiation group has missing CGI-S data.||scores on a scale||Standard Deviation|Mean
713627|NCT00216671|Secondary|Change From Baseline in PANSS Total Score at Week 12|The PANSS is a specific scale for the measurement of the symptoms of schizophrenia. Symptoms of schizophrenia will be assessed using the 30-item PANSS scale. Each item of the scale is to be scored on a scale of 1 (absent) to 7 (extreme). The total score can range from 30 to 210.|at baseline and Week 12.|Per protocol population. This excluded 42 patients in the early start group and 34 patients in the late start group. An additional 9 and 23 patients in the respective groups had missing PANSS data.||scores on a scale||Standard Deviation|Mean
713628|NCT00216671|Secondary|Change From Baseline in PANSS Total Score at Week 6|The PANSS is a specific scale for the measurement of the symptoms of schizophrenia. Symptoms of schizophrenia will be assessed using the 30-item PANSS scale. Each item of the scale is to be scored on a scale of 1 (absent) to 7 (extreme). The total score can range from 30 to 210.|at baseline and Week 6.|Per protocol population. This excluded 42 patients in the early start group and 34 patients in the late start group. An additional 3 and 5 patients in the respective groups had missing PANSS data at week 6.||scores on a scale||Standard Deviation|Mean
713629|NCT00216671|Primary|Change in Positive And Negative Syndrome Scale (PANSS) Total Score From Baseline to Endpoint|The PANSS is a specific scale for the measurement of the symptoms of schizophrenia. Symptoms of schizophrenia will be assessed using the 30-item PANSS scale. Each item of the scale is to be scored on a scale of 1 (absent) to 7 (extreme).The total score can range from 30 to 210.|at baseline and Week 26 or at premature discontinuation|Per Protocol analysis: all randomized patients who had no violation on eligibility criteria or no major protocol violation. This excluded 42 patients in the early and 34 in the late initiation group. 1 patient in the early initiation group had no PANSS at endpoint. The endpoint is the last post-baseline value of the patient.||scores on a scale||Standard Deviation|Mean
713630|NCT00216736|Post-Hoc|Proportion of Patients With Recurrent Headache Within 48 Hours for Patient Subgroup With Duration of Migraine Less Than 24 Hours|Proportion of patients who report recurrent headache within 48 hours for the patient subgroup with duration of migraine less than 24 hours|48 hours|||Participants|||Number
713631|NCT00216736|Secondary|Proportion of Patients Requiring Additional Analgesia Within 48 Hours for Headache.|Proportion of patients reporting a requirement for additional analgesia within 48 hours of treatment for headache, by telephone followup.|48 hours|||Participants|||Number
713632|NCT00216736|Primary|Proportion of Patients With Recurrent Headache Within 48 Hours.|Proportion of patients who report recurrent headache within 48 hours, on telephone followup.|48 hours|||Partcipants|||Number
713633|NCT00216736|Primary|Proportion of Patients Who Were Discharged Pain Free That Have a Recurrence of Headache Within 48 Hours.|Proportion of patients who were discharged pain free who report recurrence of headache within 48 hours, on telephone followup.|48 hours|||Participants|||Number
713634|NCT00217022|Secondary|Histologic Improvement in Post Treatment Colon Biopsies Compared to Baseline Biopsies|The histopathology scoring system included epithelial damage, lamina propria cellularity and intraepithelial lymphocytosis, each scored on a four point scale (“normal” (0), “mildly increased” (1), “moderately increased” (2), “severely increased” (3)).|Baseline (day 1 of study) and at eight weeks (approximately)|Only 8 of the subjects on the budesonide arm returned for the biopsy, so only those subjects on that arm were analyzed for this outcome measure.||participants|||Number
713635|NCT00217022|Primary|Satisfactory Control of Diarrhea During at Least Three of the Last Four Weeks|"Subjects were asked if they felt they had satisfactory control of their diarrhea, along with the number of stools and type of stool (loose, water, formed, hard) the patient were experiencing. The rating of satisfactory control of diarrhea was therefore a partially subjective measure. This outcome measure was to be recorded for three out of the last four weeks that a subject was on the study; subjects were to take part in the study approximately 8 weeks."|Three out of last four weeks that the subject was on the study|||participants|||Number
713636|NCT00217087|Primary|Change in Quality of Life|Quality of life in both groups (EMR and EMR with photodynamic therapy) SF36|end of study|25 patients did not return completed SF36 at 12 month of follow up their results were not used in final analysis.||participants|||Number
713637|NCT00217087|Primary|Fluorescence In Situ Hybridization (FISH) Markers at 12 Months.|"Whether or not positive fish markers measured by polysomy were associated with outcomes.
Markers in this study include: 9q21 /017q (her2) / 8q24/ 20q / CEP17 / 17p. Polysomy and Trisomy were documented."|12 months post therapy|4 participants in the PDT group completed at least 3 months of follow up but not 12 months||participants|||Number
713639|NCT00217399|Secondary|Tumor Marker Analysis|Number of participants with significant change in the following circulating tumor biomarkers, measured by flow cytometry: cluster designation (CD)146, CD133. Values were normalized by CD45 values(ie CD146+/CD45- and CD133+/CD45-).|1 year|14 subjects had blood specimens available for analysis||participants|||Number
713640|NCT00217399|Secondary|Number of Participants With Adverse Events|Number of patients treated with the sorafenib / anastrozole combination who experienced Grade 1-4 adverse events according to NCI common terminology criteria for adverse events (CTCAE) version 3.0|1 year|All 35 patients enrolled in the study were assessed for adverse events according to NCI common terminology criteria for adverse events (CTCAE) version 3.0.||participants|||Number
713641|NCT00217399|Primary|Complete Response + Partial Response + Stable Disease > 24 Weeks|"Clinical Outcome measured using Response Evaluation Criteria In Solid Tumors (RECIST,)V1.0, and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), a tumor that is neither growing nor shrinking.
A patient has clinical benefit from treatment if CR + PR + SD > 24 weeks."|24 weeks|Female patients with advanced or metastatic breast cancer. The protocol was initiated with intention to treat every patient enrolled with a sorafenib and anastrozole combination.||participants|||Number
713642|NCT00217425|Secondary|3-Year Overall Survival|3-year overall survival is defined as the probability of patients surviving at 3 years from study entry.|Assessed every 3 months the first 2 years from study entry and every 6 months 3-5 years from study entry.|Eligible and treated patients||probability||95% Confidence Interval|Number
713643|NCT00217425|Secondary|Overall Response Rate|Overall response rate is defined as proportion of patients who achieve complete remission [CR, unconfirmed CR (CRu) or Functional CR] or partial remission. Response is assessed using the criteria from the International Workshop to Standardize Criteria for Non-Hodgkin’s Lymphoma (Chesen, 1999).|Assessed after cycle 3, cycle 6, and cycle 8 (if given).|Eligible and treated||proportion||95% Confidence Interval|Number
713644|NCT00217425|Primary|12-Month Progression-Free Survival (PFS)|12-month progression-free survival is defined as the probability of patients remaining alive and progression-free at 12 months from study entry.|Assessed every 3 months the first 2 years from study entry and every 6 months 3-5 years from study entry.|Eligible and treated patients||probability||95% Confidence Interval|Number
713645|NCT00217438|Secondary|Relative Toxicities Between Melphalan 280 mg/m^2 or Melphalan 200 mg/m^2|Number of Grade 3-4 adverse events observed in each group from enrollment through the Day 80-120 evaluation. Grade 3-4 events are defined by the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.|Up to day 56 after transplant|Patients who were treated per protocol.||Grade 3-4 adverse events|||Number
713646|NCT00217438|Primary|CR and Near CR Rates|"Per modified European Group for Blood and Marrow Transplant (EBMT) response criteria for definition of response in patients with multiple myeloma treated by high-dose therapy and stem cell transplantation: Complete Response (CR): Complete disappearance of all clinically measurable disease, complete response requires negative tests for monoclonal proteins in serum and urine by immunofixation, no monoclonal plasma cells in marrow specimen by flow cytometry and no evidence of progressive bone disease by skeletal survey. Near Complete Response (nCR): Less than 0.1 gram/dL monoclonal protein detectable in serum by standard protein electrophoresis and less than 50 mg monoclonal protein detectable in urine on 24 hour collection. Less than 5% monoclonal plasma cells detectable in bone marrow by immunohistochemistry. No evidence of progressive bone disease by skeletal survey."|Up to 120 days after transplant|Per protocol, patients who completed the day 80-120 evaluation assessments.||percentage of participants|||Number
713647|NCT00217464|Secondary|Number of Participants With Progressive Disease at Day +90|Progressive Disease is defined as failure to achieve a statistically significant decrease in PSA rise after the day +90 PSA value|90, 60, and 30 days pre-treatment, the day of start therapy (day 0) and 30, 60 and 90 days post-treatment|All treated and eligible patients||participants|||Number
713648|NCT00217464|Primary|Proportion of Patients Who Respond to Treatment.|Response is defined to be the clear slowing of the rate of increase of PSA levels with time|90, 60, and 30 days pre-treatment, the day of start therapy (day 0) and 30, 60 and 90 days post-treatment|All treated and eligible patients||percentage of participants||95% Confidence Interval|Number
713649|NCT00217490|Primary|Change in Percentage of Fat Consumed|Self reported dietary change in consumption as collected via Block Food Frequency Questionnaire (FFQ) servings of fruit or vegetable per day and average fat consumption. This FFQ asks participants to recall their average consumption of various categories of food during the previous three months.|Baseline and 3 months|Participants who returned for follow up visit||Percentage of fat consumed||Standard Deviation|Mean
713650|NCT00217490|Primary|Change in Fruit, Vegetable Consumption as Measured by Food Frequency Questionnaire at 3 Months|Self reported dietary change in consumption as collected via Block Food Frequency Questionnaire (FFQ) servings of fruit or vegetable per day and average fat consumption. This FFQ asks participants to recall their average consumption of various categories of food during the previous three months.|Baseline and 3 months|Participant who returned for follow up visit||number of servings per day||Standard Deviation|Mean
713651|NCT00217581|Secondary|Quality of Life by EORTC Quality of Life Questionnaire (QLQ) and QLQ-STO22 for Gastric Cancer||at baseline and every 14-17 days after day 1 cycle 1 until the completion of the study or until week 26||||||
713652|NCT00217581|Secondary|Overall Survival||Patients will be followed for survival every three months after they are off study or until their disease progresses, for up to two years||||||
713653|NCT00217581|Secondary|Time to Treatment Failure||Every 21 days||||||
713654|NCT00217581|Secondary|Toxicity Profile||At 21 days following completion of study treatment||||||
713655|NCT00217581|Secondary|Response Rate by RECIST Criteria Until Progression||After every 2 cycles (1 cycle =21 days)||||||
713656|NCT00217581|Primary|Time to Progression||After every 2 cycles (1 cycle =21 days)|||months||95% Confidence Interval|Median
713657|NCT00217620|Secondary|Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0. For each patient, worst grade of each event type is reported. Grade 3 – Severe, Grade 4 – Life-threatening, Grade 5 – Fatal. Only adverse events that are possibly, probably or definitely related to study drug are reported.|Patients were assessed for adverse events two weeks after starting protocol treatment and then after every cycle of treatment (1 cycle = 28 days) for the duration of protocol treatment.|Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.||Participants|||Number
713658|NCT00217620|Primary|Objective Response (Confirmed, Complete and Partial)|Partial response (PR) is greater than or equal to 30% decrease under baseline of sum of longest diameters of all target measurable lesions; No unequivocal progression of non-measurable disease; No new lesions. Unconfirmed PR is one objective status of PR documented before progression or symptomatic deterioration. Stable disease does not qualify for CR, PR, Progression or Symptomatic Deterioration. Progressive disease is any one or more of the following: 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed; unequivocal progression of non-measurable disease; appearance of any new lesion/site; death due to disease without prior documentation of progression and without symptomatic deterioration. Assessment inadequate is progression or symptomatic deterioration has not been documented, and one or more target measurable lesions have not been assessed or inconsistent assessment methods were used.|Assessment performed every eight weeks until progression.|Eligible patients who had received any treatment were included in this analysis.||participants|||Number
713659|NCT00217620|Secondary|Four-month Progression-free Survival Rate||0 - 4 months|Eligible patients who had received any treatment were included in this analysis.||percentage of participants||95% Confidence Interval|Number
713660|NCT00217672|Secondary|Comparison of Safety and Toxicity|Evaluated using adverse event (AE) information. Detailed AE information is provided in the AE section.|When adverse events occur, up to 30 days after last dose for each subject, up to 3 years from start of study|||subjects|||Number
713661|NCT00217672|Secondary|Comparison of Response Rates, Duration of Response, and Overall Survival||Time of death, up to 3 years|Response rate – the percentage of patients assigned to a treatment arm who experience a CR or PR. Duration of response – the interval from date of initial documented response (CR or PR) to the first documented date of disease progression. Overall survival – the interval from the date of registration and the date of death.||months||95% Confidence Interval|Median
713662|NCT00217672|Primary|Antitumor Activity Based on Time to Tumor Progression (TTP).||From randomization until tumor progression|76 participants were registered to the Treatment, 7 to arm A and 69 to arm B. 6 participants randomized to arm A elected to cross over to arm B once Avastin became available. 2 out of the 69 participants randomized to arm B were found ineligible and taken off study before receiving treatment. Thus, the efficacy analysis performed on 67 patients.||months||95% Confidence Interval|Median
713663|NCT00217724|Secondary|Number of Participants With Attenuation of Myalgias or Arthralgias Not Receiving Glutamine as Measured by Pain Scale Diaries on Days 1 and 3 of Courses 1 and 2||Duration of participation on study (up to one year)||||||
713664|NCT00217724|Primary|Number of Participants With Response From Glutamine Preventing Paclitaxel Induced Myalgias or Arthralgias After 2 Courses of Chemotherapy|Complete Response (CR): Complete absence of myalgias or arthralgias Partial Response (PR): Myalgias and/or arthralgias occur but are attenuated in the cycle in which they receive active therapy by > 50% Stable Disease (SD): Less than 25% change in incidence, duration, or severity of myalgias/arthralgias Progressive Disease (PD): Symptoms worsen by >25% from baseline scores|2 courses of chemotherapy (6 weeks)|Fourteen of the 18 patients enrolled received both cycles of therapy and were thus evaluable for the primary endpoint||participants|||Number
713665|NCT00217971|Primary|Proportion of Patients Abstinent From Marijuana During Weeks 7 and 8 of the Trial|Timeline Followback self report data was collected. This daily report was used to assess the proportion of patients abstinent during weeks 7 and 8 of the clinical trial.|weeks 7 and 8|||participants|||Number
713666|NCT00218023|Primary|Mean Percentage of Cocaine-positive Urines Over Course of 12 Week Treatment in Subgroup NOT Achieving Abstinence at Baseline|Cocaine use was determined by assessing for the presence of benzoylecgonine in urine.|3 times per week (Monday, Wednesday, and Friday) for 12 weeks|||Mean % of cocaine-positive urines||Standard Error|Mean
713667|NCT00218023|Primary|Mean Percentage of Cocaine-positive Urines Over Course of 12 Week Treatment in Subgroup Achieving Abstinence at Baseline|Cocaine use was determined by assessing for the presence of benzoylecgonine in urine.|3 times per week (Monday, Wednesday, and Friday) for 12 weeks|||Mean % of cocaine-positive urines||Standard Error|Mean
713668|NCT00218062|Secondary|Medication Compliance as Indicated by Percentage of Riboflavin-positive Urine Samples||16 weeks|||% of riboflavin-positive urine samples|||Number
713669|NCT00218062|Secondary|Medication Compliance as Indicated by Percentage of Pills Taken According to Self-report||16 weeks|||percentage of pills taken|||Number
713670|NCT00218062|Primary|Retention as Indicated by the Number of Participants Who Remained in the Study||16 weeks|||participants|||Number
713671|NCT00218062|Primary|Retention as Indicated by the Number of Participants Who Completed 16 Weeks of Treatment||16 weeks|||participants|||Number
713672|NCT00218062|Primary|Cocaine Use as Assessed by the Treatment Effectiveness Score (TES), Which is the Total Number of Cocaine-negative Urines During Treatment||16 weeks|All participants who received the first dose of study medication were included in this analysis.||number of cocaine negative urines||Standard Deviation|Mean
713679|NCT00218335|Primary|Talked About Hepatitis to Drug Buddies||18 months|Data for this outcome was only measured among randomized participants (intervention and control participants), not among non-randomized and network participants. The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.||participants|||Number
713680|NCT00218335|Primary|Showed a Needleless Syringe to Drug Buddies||18 months|The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.||participants|||Number
713681|NCT00218335|Primary|Talked About HIV-related Topics With Drug Buddies (in Past Month)||18 months|The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.||participants|||Number
713682|NCT00218335|Primary|Injecting Drugs||18 months|The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.||participants|||Number
713683|NCT00218335|Primary|Number of Needle or Cooker Sharers (2 or More Versus None)||18 months|The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.||participants|||Number
713684|NCT00218335|Primary|Shared Cooker When Preparing Drugs||18 months|The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.||participants|||Number
713685|NCT00218335|Primary|Any Injection Risk (Monthly Versus Never)||18 months|The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.||participants|||Number
713686|NCT00218335|Primary|Showed a Needleless Syringe to Drug Buddies||12 months|The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.||participants|||Number
713687|NCT00218335|Primary|Talked About HIV-related Topics With Drug Buddies (in the Past Month)||12 months|The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.||participants|||Number
713688|NCT00218335|Primary|Number of Needle or Cooker Sharers (2 or More Versus None)||12 months|The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.||participants|||Number
713689|NCT00218335|Primary|Any Injection Risk (Monthly Versus Never)||12 months|The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.||participants|||Number
713690|NCT00218335|Primary|Talked About Responding to Overdose to Drug Buddies||6 months|Data for this outcome was only measured among randomized participants (intervention and control participants), not among non-randomized and network participants. The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.||participants|||Number
713691|NCT00218335|Primary|Showed a Needleless Syringe to Drug Buddies||6 months|The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.||participants|||Number
713692|NCT00218335|Primary|Talked About HIV-related Topics With Drug Buddies (in the Past Month)||6 months|The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.||participants|||Number
713693|NCT00218335|Primary|Any Sex Risk||6 months|The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.||participants|||Number
713694|NCT00218439|Other Pre-specified|Plasma Norepinephrine Concentration Response to Stress|Change in plasma norepinephrine concentrations from Resting period to those observed during a speech delivered immediately after smoking a cigarette|After 4 weeks of paroxetine / placebo|||pg / ml||Standard Error|Mean
713695|NCT00218439|Other Pre-specified|Plasma Epinephrine Concentration Response to Stress|Change in plasma epinephrine concentrations from Resting period to those observed during a speech delivered immediately after smoking a cigarette|After 4 weeks of paroxetine / placebo|||pg / ml||Standard Error|Mean
713696|NCT00218439|Other Pre-specified|Heart Rate Response to Stress|Change in heart rate from Resting period to that observed during a speech delivered immediately after smoking a cigarette|After 4 weeks of paroxetine / placebo|||beats/minute||Standard Error|Mean
713697|NCT00218439|Other Pre-specified|Diastolic Blood Pressure Response to Stress|Change in diastolic blood pressure from Resting period to that observed during a speech delivered immediately after smoking a cigarette|After 4 weeks of paroxetine / placebo|||mm Hg||Standard Error|Mean
713698|NCT00218439|Primary|Systolic Blood Pressure Response to Stress|Change in systolic blood pressure from Resting period to that observed during a speech delivered immediately after smoking a cigarette|After 4 weeks of paroxetine / placebo|||mmHg||Standard Error|Mean
713699|NCT00218465|Primary|Days to Relapse Within the 60 Days Following Randomization||60 days|||days||Standard Deviation|Mean
713700|NCT00218465|Primary|Number of Abstinent and Nonabstinent Participants at End of 5 Week Placebo-controlled Relapse Prevention Trial||5 weeks|||participants|||Number
713701|NCT00218465|Primary|Time to Relapse to Smoking in the 5-week Relapse Prevention Phase.||5 weeks|||days||Standard Deviation|Mean
713702|NCT00218543|Primary|ADHD Symptoms Based on Adult ADHD Rating Scale Scale (AARS)|Weekly AARS scores (continuous, range 0-54) were examined with the baseline score compared to that at the last assessment obtained and change in these scores over time. The AARS looks at adult ADHD symptoms. A score of 0 represents no symptoms and 54 would be indicative of the most severe level of symptoms.|measured during 12 weeks or length of study participation|Comparing overall baseline scores to end of study scores for patients who had at least two AARS weekly measures completed||scores on a scale||Standard Deviation|Mean
713703|NCT00218543|Primary|the Adult ADHD Rating Scale (AARS) (30% Reduction)|AARS is a self report that measures symptoms of adult ADHD. The primary outcome was the percentage of patients achieving a 30% reduction from baseline on the AARS scale. The AARS is scored on a continuous, range 0-54. 0 being no symptoms and 54 being indicative of the most severe level of symptoms.|baseline compared to rating at week 12 or last rating during study participation|All participants||percent of participants|||Number
713704|NCT00212264|Primary|Percent Change in Incontinence Episodes Per Week on Bladder Diary|[(Baseline incontinence episodes minus 12-month incontinence episodes)/baseline incontinence episodes] x 100%|1 year|This outcome was to measure treatment durability. The no-treatment control group completed the study after the primary outcome was collected at 2 months. At that time, they were offered treatment for this burdensome condition outside the study. Only the 2 active treatment groups continued in the study for 1 full year.||% change in episodes per week||95% Confidence Interval|Mean
713705|NCT00212264|Primary|Percent Change in Incontinence Episodes on Bladder Diary|[(Baseline incontinence episodes minus 2-month incontinence episodes)/baseline incontinence episodes] x 100%|2 months|||% change in episodes per week||95% Confidence Interval|Mean
713706|NCT00212355|Primary|Safety|No of patients who have at least one adverse events.|During study period (up to 96W )|The analysis was performed based on FAS population||participants|||Number
713707|NCT00212758|Secondary|Change in Height at 56 Weeks||week 1, week 56|||cm||Standard Deviation|Mean
713708|NCT00212758|Primary|The Change in Amount of Insulin Like Growth Factor (IGF-I) Generated (Day 8-day 1)|We will measure the amount of serum IGF-I generated after 7 days of growth hormone therapy (Day8-Day1).|Day 1 & Day 8|||mcg/L||Standard Deviation|Mean
713709|NCT00218634|Secondary|CD4+ Lymphocyte Count at 3-month Follow-up Assessment.|CD4+ lymphocyte cell count at 3-month follow-up assessment.|3-month assessment|We used intent to treat for all analysis.||cells/mm3||Standard Deviation|Mean
713710|NCT00218634|Secondary|HIV Viral Load at 3-month Follow-up Assessment|HIV plasma RNA (log HIV viral load)at the 3-month follow-up assessment.|3-month assessment|We used intent to treat for all data analysis.||"log10 copies/mL"||Standard Deviation|Mean
713711|NCT00218634|Secondary|Clinician-assessed Depression at 12-month Follow-up Assessment|Depression was assessed using the Montgomery-Asberg Depression Rating Scale (MADRS) by a clinical interviewer blind to participants' study condition. The scale ranges from 0 to 60 with 7-19 indicating mild depression and 20-34 indicating moderate depression.|12-month follow-up assessment|We used intent to treat for all data analysis.||Units on scale||Standard Deviation|Mean
713712|NCT00218634|Primary|Percent Medication Adherence at 12-month Follow-up Assessment|Follow-up assessment in adherence to HIV medication. Doses taken were assessed by downloading information from the electronic pill cap and corroborated by participant self-report. Adherence was calculated as the number of doses taken over the time period divided by the number of doses prescribed.|12-month follow-up assessment|We used intent to treat for all data analysis.||percent (doses taken/doses prescribed)||Standard Deviation|Mean
713713|NCT00218634|Secondary|CD4+ Lymphocyte Count at 12-month Follow-up Assessment.|CD4+ lymphocyte cell count at 12-month follow-up assessment.|12-month follow-up assessment|We used intent to treat for all data analysis.||cells/mm3||Standard Deviation|Mean
713714|NCT00218634|Secondary|HIV Viral Load at 12-month Follow-up Assessment|HIV plasma RNA (log HIV viral load)at the 12-month follow-up assessment.|12-month follow-up assessment|We used intent to treat for all data analysis.||"log10 copies/mL"||Standard Deviation|Log Mean
713715|NCT00218634|Secondary|Clinician-assessed Depression Rating at 3 Month Follow-up Assessment|Depression was assessed using the Montgomery-Asberg Depression Rating Scale (MADRS) by a clinical interviewer blind to participants' study condition. The scale ranges from 0 to 60 with 7-19 indicating mild depression and 20-34 indicating moderate depression.|3 month follow-up|We used intent to treat for all data analysis.||Units on scale||Standard Deviation|Mean
713716|NCT00218634|Primary|Percent Medication Adherence at 3-month Follow-up Assessment|Post-treatment assessment in adherence to HIV medication. Doses taken were assessed by downloading information from the electronic pill cap and corroborated by participant self-report. Adherence was calculated as the number of doses taken over the time period divided by the number of doses prescribed.|3-month assessment|We used hierarchical linear modeling (HLM) methods and intent to treat for all randomized participants.||percent (doses taken/doses prescribed)||Standard Deviation|Mean
713717|NCT00219141|Secondary|Change From Baseline in Mean 24-hour Ambulatory Diastolic and Systolic Blood Pressure From Baseline to the End of the Study (Week 36)|Two 24-hour ambulatory blood pressure monitoring (ABPM) evaluations were performed, one at baseline and one at the end of the study. For each evaluation, the ABPM device was attached to the non-dominant arm of the patient. A correlation was made between the ABPM device readings and measurements taken with a mercury sphygmomanometer and stethoscope. Following the correlation procedure, blood pressure was measured at study specified intervals.|Baseline the end of study (Week 36)|Ambulatory blood pressure monitoring completers population: All patients that completed both ambulatory blood pressure monitoring assessments successfully.||mm Hg||Standard Error|Least Squares Mean
713718|NCT00219141|Secondary|Change in the Left Ventricular Hypertrophy (LVH) Parameter Cornell Voltage Duration Product as Measured by Electrocardiogram From Baseline to End of Study (Week 36)||Baseline to end of study (Week 36)|Intent-to-treat population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement.||mm * ms||Standard Deviation|Mean
713719|NCT00219141|Secondary|Change in the Left Ventricular Hypertrophy (LVH) Parameter Sokolow-Lyon Voltage as Measured by Electrocardiogram From Baseline to End of Study (Week 36)||Baseline to end of study (Week 36)|Intent-to-treat population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement.||mm||Standard Deviation|Mean
713720|NCT00219141|Secondary|Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Stroke Volume as Measured by MRI From Baseline to End of Study (Week 36)||Baseline to end of study (Week 36)|Efficacy population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement patients and who had been treated for at least 28 weeks and had evaluable MRI assessments both at baseline and at the end of the study.||mL||Standard Deviation|Mean
713721|NCT00219141|Secondary|Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Ejection Fraction as Measured by MRI From Baseline to End of Study (Week 36)||Baseline to end of study (Week 36)|Efficacy population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement patients and who had been treated for at least 28 weeks and had evaluable MRI assessments both at baseline and at the end of the study.||percent||Standard Deviation|Mean
713763|NCT00219544|Secondary|Change in Pain Scores During Double Blind Treatment Phase|Change in Mean Pain score = Mean of last 7 available pain scores from daily pain diary while on single-blind treatment. A Daily Pain Rating Score : 11-point numerical scale ranging from 0 (“no pain”) to 10 (“worst possible pain”).|9 weeks|Full Analysis Set (FAS)||score on scale||Standard Error|Least Squares Mean
713722|NCT00219141|Secondary|Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular End Diastolic Mass as Measured by MRI From Baseline to End of Study (Week 36)||Baseline to end of study (Week 36)|Efficacy population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement patients and who had been treated for at least 28 weeks and had evaluable MRI assessments both at baseline and at the end of the study.||g||Standard Deviation|Mean
713723|NCT00219141|Secondary|Change in the Left Ventricular Hypertrophy (LVH) Parameter Diameter of Ascending Aorta as Measured by MRI From Baseline to End of Study (Week 36)||Baseline to end of study (Week 36)|Efficacy population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement patients and who had been treated for at least 28 weeks and had evaluable MRI assessments both at baseline and at the end of the study.||mm||Standard Deviation|Mean
713724|NCT00219141|Secondary|Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Inferolateral Wall Thickness as Measured by MRI From Baseline to End of Study (Week 36)||Baseline to end of study (Week 36)|Efficacy population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement patients and who had been treated for at least 28 weeks and had evaluable MRI assessments both at baseline and at the end of the study.||mm||Standard Deviation|Mean
713725|NCT00219141|Secondary|Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Anteroseptal Wall Thickness as Measured by MRI From Baseline to End of Study (Week 36)||Baseline to end of study (Week 36)|Efficacy population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement patients and who had been treated for at least 28 weeks and had evaluable MRI assessments both at baseline and at the end of the study.||mm||Standard Deviation|Mean
713726|NCT00219141|Secondary|Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular End Systolic Volume as Measured by MRI From Baseline to End of Study (Week 36)||Baseline to end of study (Week 36)|Efficacy population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement patients and who had been treated for at least 28 weeks and had evaluable MRI assessments both at baseline and at the end of the study.||mL||Standard Deviation|Mean
713727|NCT00219141|Secondary|Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular End Diastolic Volume as Measured by MRI From Baseline to End of Study (Week 36)||Baseline to end of study (Week 36)|Efficacy population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement patients and who had been treated for at least 28 weeks and had evaluable MRI assessments both at baseline and at the end of the study.||mL||Standard Deviation|Mean
713728|NCT00219141|Secondary|Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Mass Index as Measured by MRI From Baseline to End of Study (Week 36)||Baseline to end of study (Week 36)|Efficacy population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement patients and who had been treated for at least 28 weeks and had evaluable MRI assessments both at baseline and at the end of the study.||g/m^2||Standard Deviation|Mean
713729|NCT00219141|Primary|Change in Left Ventricular Mass Index (LVMI) From Baseline to End of Study (Week 36)|Left ventricular mass index (LVMI) was measured by magnetic resonance imaging (MRI). An increase in LVMI indicates hypertrophy of the left ventricle. This could be a normal reversible response to cardiovascular conditioning (athletic heart) or an abnormal irreversible response to chronically increased volume load (preload) or increased pressure load (afterload). Thickening of the ventricular muscle results in increased left ventricular pressure, increased end-systolic volume, and decreased end-diastolic volume, causing an overall reduction in cardiac output.|Baseline to end of study (Week 36)|Efficacy population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement patients and who had been treated for at least 28 weeks and had evaluable MRI assessments both at baseline and at the end of the study.||g/m^2||Standard Error|Least Squares Mean
713730|NCT00219284|Secondary|Change in the 39-item Parkinson's Disease Questionnaire (PDQ-39) Total Score From Baseline to End of Treatment|The PDQ-39 is another instrument used to assess quality of life in individuals with Parkinson's disease. The questionnaire provides scores on eight scales: Mobility, activities of daily living, emotions, stigma, social support, cognition, communication, and bodily discomfort. Questions are scored on a 5-point Likert scale ranging from 1 (never) to 3 (sometimes) to 5 (always). The 1 to 5 range was recoded to 0 to 4 for the analysis. The total score can range from 0 to 156. A lower score indicates better quality of life. A negative change score indicates an improvement.|Baseline to end of treatment (Week 16 in the Immediate Switch group, Week 20 in the Delayed Switch group)|ITT population - For each patient, the last post-baseline measurement during the treatment phase was used as the end-of-treatment measurement. Only patients with baseline and end-of-treatment PDQ-39 scores were included in the analysis.||Units on a scale||Standard Error|Least Squares Mean
713731|NCT00219284|Secondary|Change in Parkinson's Disease Quality of Life Score From Baseline to End of Treatment|Quality of life was assessed with the Parkinson’s Disease Quality of Life Instrument (PDQUALIF), a 33-item self-reported questionnaire which includes seven domains: Social/role function, self-imaging/sexuality, sleep, outlook, physical function, independence, and urinary function. Questions are scored on a 5-point Likert scale ranging from 1 (never) to 3 (sometimes) to 5 (always). The 1 to 5 range was recoded to 0 to 4 for the analysis. The total score can range from 0 to 132. A lower score indicates better quality of life. A negative change score indicates improvement.|Baseline to end of treatment (Week 16 in the Immediate Switch group, Week 20 in the Delayed Switch group)|ITT population - For each patient, the last post-baseline measurement during the treatment phase was used as the end-of-treatment measurement. Only patients with baseline and end-of-treatment PDQUALIF scores were included in the analysis.||Units on a scale||Standard Error|Least Squares Mean
713764|NCT00219544|Secondary|Weekly Mean Pain Scores During the Double Blind Treatment Phase|Mean Pain scores for weeks 4, 5, 6, 7, 8 and 9. Mean of last 7 available pain scores from daily pain diary while on single-blind treatment. A Daily Pain Rating Score : 11-point numerical scale ranging from 0 (“no pain”) to 10 (“worst possible pain”).|Week 4 - 9|FAS population.||score on scale||Standard Deviation|Mean
713732|NCT00219284|Secondary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score From Baseline to End of Treatment|Motor function was assessed with the UPDRS part III. There are 14 items in the instrument, each measured on a 5 point scale (0-4): Speech, facial expression, tremor at rest, action tremor, rigidity, finger taps, hand movements, hand pronation and supination, leg agility, arising from chair, posture, gait, postural stability, and body bradykinesia. The sum of scores can range from 0 to 56; a higher score indicates greater disability. A negative change score indicates improvement.|Baseline to end of treatment (Week 16 in the Immediate Switch group, Week 20 in the Delayed Switch group)|ITT population - For each patient, the last post-baseline measurement during the treatment phase was used as the end-of-treatment measurement. Only patients with baseline and end-of-treatment UPDRS part III scores were included in the analysis.||Units on a scale||Standard Error|Least Squares Mean
713733|NCT00219284|Secondary|Change in the 39-item Parkinson's Disease Questionnaire (PDQ-39) Total Score From Baseline to Week 8|The PDQ-39 is another instrument used to assess quality of life in individuals with Parkinson's disease. The questionnaire provides scores on eight scales: Mobility, activities of daily living, emotions, stigma, social support, cognition, communication, and bodily discomfort. Questions are scored on a 5-point Likert scale ranging from 1 (never) to 3 (sometimes) to 5 (always). The 1 to 5 range was recoded to 0 to 4 for the analysis. The total score can range from 0 to 156. A lower score indicates better quality of life. A negative change score indicates an improvement.|Baseline to Week 8|Intent-to-treat (ITT) population: All randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of the primary efficacy variable. Only patients with baseline and Week 8 PDQ-39 scores were included in the analysis.||Units on a scale||Standard Error|Least Squares Mean
713734|NCT00219284|Secondary|Change in the 39-item Parkinson's Disease Questionnaire (PDQ-39) Total Score From Baseline to Week 4|The PDQ-39 is another instrument used to assess quality of life in individuals with Parkinson’s disease. The questionnaire provides scores on eight scales: Mobility, activities of daily living, emotions, stigma, social support, cognition, communication, and bodily discomfort. Questions are scored on a 5-point Likert scale ranging from 1 (never) to 3 (sometimes) to 5 (always). The 1 to 5 range was recoded to 0 to 4 for the analysis. The total score can range from 0 to 156. A lower score indicates better quality of life. A negative change score indicates an improvement.|Baseline to Week 4|Intent-to-treat (ITT) population: All randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of the primary efficacy variable. Only patients with baseline and Week 4 PDQ-39 scores were included in the analysis.||Units on a scale||Standard Error|Least Squares Mean
713735|NCT00219284|Secondary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score From Baseline to Week 8|Motor function was assessed with the UPDRS part III. There are 14 items in the instrument, each measured on a 5-point scale (0-4): Speech, facial expression, tremor at rest, action tremor, rigidity, finger taps, hand movements, hand pronation and supination, leg agility, arising from chair, posture, gait, postural stability, and body bradykinesia. The sum of scores can range from 0 to 56; a higher score indicates greater disability. A negative change score indicates improvement.|Baseline to Week 8|Intent-to-treat (ITT) population: All randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of the primary efficacy variable. Only patients with baseline and Week 8 UPDRS part III scores were included in the analysis.||Units on a scale||Standard Error|Least Squares Mean
713736|NCT00219284|Secondary|Change in Parkinson's Disease Quality of Life Score From Baseline to Week 8|Quality of life was assessed with the Parkinson’s Disease Quality of Life Instrument (PDQUALIF), a 33-item self-reported questionnaire which includes seven domains: Social/role function, self-imaging/sexuality, sleep, outlook, physical function, independence, and urinary function. Questions are scored on a 5-point Likert scale ranging from 1 (never) to 3 (sometimes) to 5 (always). The 1 to 5 range was recoded to 0 to 4 for the analysis. The total score can range from 0 to 132. A lower score indicates better quality of life. A negative change score indicates improvement.|Baseline to Week 8|Intent-to-treat (ITT) population: All randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of the primary efficacy variable. Only patients with baseline and Week 8 PDQUALIF scores were included in the analysis.||Units on a scale||Standard Error|Least Squares Mean
713737|NCT00219284|Secondary|Change in Parkinson’s Disease Quality of Life Score From Baseline to Week 4|Quality of life was assessed with the Parkinson’s Disease Quality of Life Instrument (PDQUALIF), a 33-item self-reported questionnaire which includes seven domains: Social/role function, self-imaging/sexuality, sleep, outlook, physical function, independence, and urinary function. Questions are scored on a 5-point Likert scale ranging from 1 (never) to 3 (sometimes) to 5 (always). The 1 to 5 range was recoded to 0 to 4 for the analysis. The total score can range from 0 to 132. A lower score indicates better quality of life. A negative change score indicates improvement.|Baseline to Week 4|Intent-to-treat (ITT) population: All randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of the primary efficacy variable. Only patients with baseline and Week 4 PDQUALIF scores were included in the analysis.||Units on a scale||Standard Error|Least Squares Mean
713738|NCT00219284|Primary|Change in Unified Parkinson’s Disease Rating Scale (UPDRS) Part III Score From Baseline to Week 4|Motor function was assessed with the UPDRS part III. There are 14 items in the instrument, each measured on a 5 point scale (0-4): Speech, facial expression, tremor at rest, action tremor, rigidity, finger taps, hand movements, hand pronation and supination, leg agility, arising from chair, posture, gait, postural stability, and body bradykinesia. The sum of scores can range from 0 to 56; a higher score indicates greater disability. A negative change score indicates improvement.|Baseline to Week 4|Intent-to-treat (ITT) population: All randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of the primary efficacy variable. Only patients with baseline and Week 4 UPDRS part III scores were included in the analysis.||Units on a scale||Standard Error|Least Squares Mean
713748|NCT00219544|Secondary|Change in Euro Quality of Life (EQ-5D) Health State Profile and Visual Analog Scale Components|two components to the EQ-5D: a Health State Profile (scores from five domains are used to calculate the utility score :0 refers to dead and a score of 1 refers to perfect health) and a Visual Analogue Scale (VAS) (0 represents the worst imaginable health state and 100 represents the best imaginable health state)|Week 9|||score on scale||Standard Error|Least Squares Mean
713749|NCT00219544|Secondary|Change in Modified Brief Pain Inventory (mBPI) for Pain Interference or Pain Severity.|Mean Change from Randomization: score at mBPI observation minus score at randomization. mBPI is extent to which pain interferes with daily activities on a 0 (no interference) to 10 (completely interfered) scale.|Week 9|FAS population||score on scale||Standard Error|Least Squares Mean
713750|NCT00219544|Secondary|Patient Global Impression of Change (PGIC) Categories by Number of Subjects|"Number of subjects that responded to PGIC Categories. PGIC is a subject-rated instrument that measures change in the subject’s overall status on a 7-point scale. Scores range from
1 (very much improved) to 7 (very much worse)."|Week 9|FAS Population||participants|||Number
713751|NCT00219544|Secondary|Change in Pain Treatment Satisfaction Scale (PTSS)|"Mean Change: score from observation minus score from randomization: PTSS “Impact” module of 8-items & “Satisfaction” module of 6-items; item scores 1-5.
Mean score for each module transformed onto scale 0- 100, where score 0 =worst possible response and score 100
=best possible response: Score =[(5 – mean non-missing items)*100]/4."|Week 9|||score on scale||Standard Error|Least Squares Mean
713752|NCT00219544|Secondary|Change in Hospital Anxiety and Depression Scale Responses|Mean Change from Randomization in Score from Hospital Anxiety and Depression Scale (HADS): 2 subscales, measuring anxiety (HADS-A)and depression (HADS-D). 7 items in each subscale assessed on a scale of 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). which yields the score ranging 0-21.|Week 9|FAS population||score on scale||Standard Error|Least Squares Mean
713753|NCT00219544|Secondary|Intensity of Neuropathic Pain –Visual Analog Scale (NeP – VAS)|Change in Scale from randomization to Week 9. Scale to measure Neuropathic Pain –Visual Analog Scale (NeP – VAS): the subject places a mark on the VAS scale (0 to 100) where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.|Week 4, Week 9|||scores on a scale||Standard Error|Least Squares Mean
713754|NCT00219544|Secondary|Change in Sleep Interference Scores During Double Blind Treatment Phase|"Change in Mean SI score: Mean SI score at observation minus mean SI score at week 4. Mean SI Score = mean of last 7 available SI scores from daily SI diary while on single-blind treatment. Daily SI rating scale (DSIS) is 11-point numerical scale : Zero means pain does not interfere with sleep and 10 means pain completely interferes with sleep."|9 weeks|Full Analysis Set (FAS)||score on scale||Standard Error|Least Squares Mean
713755|NCT00219544|Secondary|Weekly Mean Sleep Interference Scores During the Double Blind Treatment Phase|Mean Sleep Interference scores for weeks 4, 5, 6, 7, 8 and 9. Mean of last 7 available SI scores from daily SI diary while on single-blind treatment. Daily SI rating scale (DSIS) consists of an 11-point numerical scale : Zero means “pain does not interfere with sleep” and 10 means “pain completely interferes with sleep.”|Week 9|||score on scale||Standard Deviation|Mean
713756|NCT00219544|Secondary|Weekly Mean Sleep Interference Scores During the Single-Blind Treatment Phase|Sleep Interference (SI) score at Week 0 and Week 4, end of single-bind treatment. Mean of last 7 available SI scores from daily SI diary while on single-blind treatment. Daily SI rating scale (DSIS) consists of an 11-point numerical scale : Zero means “pain does not interfere with sleep” and 10 means “pain completely interferes with sleep.”|0 and 4 weeks|Last observation carried forward (LOCF) approach for patients who do not complete the study will be adopted. This is defined as the mean of the last 7 diary scores while on Double-Blind study drug, up to and including the day after the last day on drug (excluding the taper phase).||score on scale||Standard Deviation|Mean
713757|NCT00219544|Secondary|Mean Sleep Interference Score|Mean Sleep Interference (SI) score at end of Double-Blind treatment = mean of last 7 available SI scores from daily SI diary while on Double-Blind treatment. Daily SI rating scale (DSIS) consists of an 11-point numerical scale : Zero means “pain does not interfere with sleep” and 10 means “pain completely interferes with sleep.”|Week 9|FAS population.||score on scale||Standard Error|Least Squares Mean
713758|NCT00219544|Secondary|Time to Meaningful Increase in Pain During Double-blind Treatment Phase (Number of Participants)|Number of participants who experienced a meaningful increase in pain also includes participants who took rescue medication for pain due to peripheral neuropathic pain or discontinued from the study .|Week 9|||participants|||Number
713759|NCT00219544|Secondary|Categorized Daily Pain Score|Mean number of days in each pain category. DPRS Daily Pain Rating Score Categories: No pain (score 0), Mild pain (scores 1-3), Moderate pain (scores 4-6), Severe pain (scores 7-10)|Week 9|Number of subjects analyzed for each pain category.||days||Standard Deviation|Mean
713760|NCT00219544|Secondary|Mean Pain Score for Non-responders at End of Single-blind Treatment Phase|Change from baseline of mean of last 7 available pain scores from daily pain diary while on single-blind treatment. Daily Pain Rating Score:11-point numerical scale 0 (“no pain”) to 10 (“worst possible pain”). Non-Responders = <30% reduction in mean pain score at end of single-blind treatment phase compared to weekly mean pain score at baseline.|Week 4|number of subjects that can be analyzed for Change from Baseline at End of Single Blind.||score on scale||Standard Deviation|Mean
713761|NCT00219544|Secondary|Mean Pain Score for Responders at End of Single-blind Treatment Phase. Change From Baseline of Mean of Last 7 Available Pain Scores From Daily Pain Diary While on Single-blind Treatment.|Daily Pain Rating Score:11-point numerical scale 0 (“no pain”) to 10 (“worst possible pain”). Responders = ≥30% reduction in mean pain score at end of single-blind treatment phase compared to weekly mean pain score at baseline.|Week 4|number of subjects that can be analyzed for Change from Baseline at End of Single Blind.||score on scale||Standard Deviation|Mean
713762|NCT00219544|Secondary|Number of Subjects With >= 30% Reduction in Mean Pain Score During Single-blind Treatment|Responders = ≥30% reduction in mean pain score at end of single-blind treatment phase compared to weekly mean pain score at baseline. Mean of last 7 available pain scores from daily pain diary while on single-blind treatment. A Daily Pain Rating Score : 11-point numerical scale ranging from 0 (“no pain”) to 10 (“worst possible pain”).|Week 4 (end of single-blind treatment phase)|256 subjects entered the single-blind treatment phase, one subject did not have enough DPRS assessments for calculation.||participants|||Number
713765|NCT00219544|Secondary|Weekly Mean Pain Scores During the Single-blind Treatment Phase|Pain score at Week 0 and Week 4, end of single-bind treatment. Mean of last 7 available pain scores from daily pain diary while on single-blind treatment. A Daily Pain Rating Score : 11- point numerical scale ranging from 0 (“no pain”) to 10 (“worst possible pain”).|0 and 4 weeks|Full Analysis Set (FAS)||score on scale||Standard Deviation|Mean
713766|NCT00219544|Primary|Neuropathic Pain in Subjects With Peripheral Neuropathic Pain Conditions During the Double-blind Phase|Pain score end of Double-Blind treatment = mean of last 7 available pain scores from daily pain diary while on Double-Blind treatment. A Daily Pain Rating Score : 11- point numerical scale ranging from 0 (“no pain”) to 10 (“worst possible pain”).|9 weeks|Full Analysis Set (FAS) = Intent-to-Treat (ITT) population, defined as all subjects who are randomized into the Double-Blind treatment phase, who receive at least one dose of Double-Blind study medication and complete at least one postrandomization efficacy assessment.||score on scale||Standard Error|Least Squares Mean
713767|NCT00219557|Secondary|Change From Baseline in 26-item Pancreatic Cancer-specific Quality of Life Questionnaire (QLQ-PAN26) Score at Day 1 of Every Cycle and End of Study|QLQ-PAN26 consists of 26 questions (Qs) relating to disease symptoms, treatment (Tx) side effects and emotional issues specific to pancreatic cancer (PC). Questions include on altered bowel habits, pain, dietary changes, disease and Tx-related symptoms and issues related to the emotional and social well-being of participants with PC. All 26 Qs are answered on 4-point Likert scale ranging from ‘1=not at all’ to 4=’very much’ and subsequently transformed into scales that range from 0-100. Higher scores on functioning scales=better functioning; higher scores on the symptom scales=more symptoms.|Phase 2 baseline [Day (D) 1 of Cycle (C)1], Day 1 of all subsequent cycles up to Cycle 14 and end of study (EoS).|Phase 2 ITT population was the primary analysis population. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. n signifies the number of participants evaluable for the respective scale at the respective time point.||units on a scale||Standard Deviation|Mean
713768|NCT00219557|Secondary|Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score at Day 1 of Every Cycle and End of Study|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4-point scale (1 ‘Not at All’ to 4 ‘Very Much’); 2 questions used 7-point scale (1 ‘Very Poor’ to 7 ‘Excellent’). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms. Change from baseline=Cycle/Day score minus baseline score.|Phase 2 baseline [Day (D)1 of Cycle (C)1], Day 1 of all subsequent cycles up to Cycle 14 and end of study (EoS).|Phase 2 ITT population was the primary analysis population. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. n signifies the number of participants evaluable for the respective scale at the respective time point.||units on a scale||Standard Deviation|Mean
713769|NCT00219557|Secondary|One Year Survival Probability|One year survival probability was defined as the probability of survival at one year after the date of randomization based on the Kaplan Meier estimate.|Phase 2 baseline to disease progression or death due to any cause or at least 1 year after the first dose for the last participant|Phase 2 ITT population included all participants randomized with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or a drug different from that to which they were randomized.||Percent chance of survival||95% Confidence Interval|Number
713770|NCT00219557|Secondary|Progression-free Survival (PFS)|"Time in days from randomization to first documentation of objective tumor progression or death due to any cause. PFS was calculated as first event date minus the date of randomization plus 1. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Phase 2 baseline until the date of first documented progression or death due to any cause, assessed every 8 weeks up to 80 weeks|Phase 2 ITT population included all participants randomized with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or a drug different from that to which they were randomized.||Days||95% Confidence Interval|Number
713771|NCT00219557|Secondary|Duration of Response (DR)|Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Phase 2 baseline to disease progression or discontinuation from study due to any cause, assessed every 8 weeks up to 80 weeks|Subgroup of participants from Phase 2 ITT population, with a confirmed objective tumor response (CR or PR).||Days||95% Confidence Interval|Median
713772|NCT00219557|Secondary|Percentage of Participants With Overall Response (OR)|Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum of longest dimensions.|Phase 2 baseline to disease progression or discontinuation from study, assessed every 8 weeks up to 80 weeks|Phase 2 ITT population included all participants randomized with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or a drug different from that to which they were randomized.||Percentage of Participants||95% Confidence Interval|Number
713773|NCT00219557|Secondary|Population Pharmacokinetics of Axitinib (AG-013736) in Phase 2|Data for this outcome measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Phase 2 Day 1 (Pre-dose), Day 29, Day 57 and then every 8 weeks until disease progression or discontinuation from study or up to 80 weeks||||||
713880|NCT00224120|Secondary|Change From Baseline in Maximum Urine Flow Rate (Qmax) at 12 Weeks||Baseline and 12 weeks|||mL/min||Standard Deviation|Mean
713774|NCT00219557|Secondary|Plasma Decay Half-life (t1/2) of Gemcitabine|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 9 and 12 hr after start of infusion on Day 15 of Phase 1 Cycle 1|Phase 1 PK evaluable population included all participants who completed PK blood sampling on at least 1 day. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||hr||Standard Deviation|Mean
713775|NCT00219557|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Gemcitabine|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 9 and 12 hr after start of infusion on Day 15 of Phase 1 Cycle 1|Phase 1 PK evaluable population included all participants who completed PK blood sampling on at least 1 day. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||ng*hr/mL||Standard Deviation|Mean
713776|NCT00219557|Secondary|Maximum Observed Plasma Concentration (Cmax) of Gemcitabine||0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 9 and 12 hr after start of infusion on Day 15 of Phase 1 Cycle 1|Phase 1 PK evaluable population included all participants who completed PK blood sampling on at least 1 day. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||ng/mL||Standard Deviation|Mean
713777|NCT00219557|Secondary|Plasma Decay Half-life (t1/2) of Axitinib (AG-013736)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.5, 1, 1.5, 2, 3.5, 4.5, 9.5, and 12.5 hr post-dose on Day 15 of Phase 1 Cycle 1|Phase 1 PK evaluable population included all participants who completed PK blood sampling on at least 1 day.||hr||Standard Deviation|Mean
713778|NCT00219557|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Axitinib (AG-013736)|Tmax was based on the actual time points when the samples were collected.|0 (pre-dose), 0.5, 1, 1.5, 2, 3.5, 4.5, 9.5, and 12.5 hr post-dose on Day 15 of Phase 1 Cycle 1|Phase 1 PK evaluable population included all participants who completed PK blood sampling on at least 1 day.||hr||Full Range|Median
713779|NCT00219557|Secondary|Area Under the Curve From Time Zero to 24 Hours [AUC (0-24)] of Axitinib (AG-013736)|AUC (0-24) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to 24 hours (0-24).|0 (pre-dose), 0.5, 1, 1.5, 2, 3.5, 4.5, 9.5, and 12.5 hr post-dose on Day 15 of Pase 1 Cycle 1|Phase 1 PK evaluable population included all participants who completed PK blood sampling on at least 1 day.||ng*hr/mL||Standard Deviation|Mean
713780|NCT00219557|Secondary|Maximum Observed Plasma Concentration (Cmax) for Axitinib (AG-013736)||0 (pre-dose), 0.5, 1, 1.5, 2, 3.5, 4.5, 9.5, and 12.5 hours (hr) post-dose on Day 15 of Phase 1 Cycle 1|Phase 1 Pharmacokinetic (PK) evaluable population included all ITT participants who completed PK blood sampling on at least 1 day.||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
713781|NCT00219557|Secondary|Dose Confirmation of Gemcitabine on Basis of Number of Participants With Dose Limiting Toxicity (DLT)|Dose of gemcitabine was confirmed if not more than 1 out of 6 participants experienced a DLT during first cycle. DLT included grade (Gr) 4 neutropenia or thrombocytopenia, greater than or equal to (>=) Gr 3 anemia or nonhematological toxicities for >= 7 days (except alopecia) or >= Gr 1 hemoptysis or >=2 gram /24 hours proteinuria or inability to resume background chemotherapy or axitinib (AG-013736) dosing within 14 days of stopping due to treatment related toxicity.|Phase 1 Baseline up to Week 4|Phase 1 safety population included all participants who received at least 1 dose of study drug with treatment assignments designated according to actual study treatment received. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||participants|||Number
713782|NCT00219557|Secondary|Dose Confirmation of Axitinib (AG-013736) on Basis of Number of Participants With Dose Limiting Toxicity (DLT)|Dose of axitinib (AG-013736) was confirmed if not more than 1 out of 6 participants experienced a DLT during first cycle. DLT included grade (Gr) 4 neutropenia or thrombocytopenia, greater than or equal to (>=) Gr 3 anemia or nonhematological toxicities for >= 7 days (except alopecia) or >= Gr 1 hemoptysis or >=2 gram /24 hours proteinuria or inability to resume background chemotherapy or axitinib (AG-013736) dosing within 14 days of stopping due to treatment related toxicity.|Phase 1 baseline up to Week 4|Phase 1 safety population included all participants who received at least 1 dose of study drug with treatment assignments designated according to actual study treatment received. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||participants|||Number
713783|NCT00219557|Primary|Overall Survival (OS)|Time in days from randomization to date of death due to any cause. OS was calculated as the death date minus the the date of randomization plus 1. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Baseline of Phase 2 to death or until at least 1 year after the randomization of the last participant|Phase 2 intent to treat (ITT) population included all participants randomized with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or a drug different from that to which they were randomized.||Days||95% Confidence Interval|Median
713784|NCT00220636|Secondary|Change in Beck Depression Inventory (BDI) Score|"21 item patient rated assessment of depression symptoms, with item scores ranging from 0 to 3. Total BDI scores can range from 0 to 63, with higher scores indicating worse depression.
Outcome is the subject's total BDI score post-treatment compared to the subject's total BDI score pre-treatment."|baseline and 12 weeks|Number of participants for whom data was available after starting aripiprazole augmentation||points on BDI scale||Standard Deviation|Mean
713785|NCT00220636|Secondary|Change in Global Assessment of Functioning Scale (GAFS)|Ranging from 0 to 100, with higher score indicating better global functioning. Outcome is the post-treatment GAFS score compared to the pre-treatment GAFS score.|baseline and 12 weeks|All subjects (14/15) for whom data was available after starting aripiprazole augmentation||points on GAFS scale||Standard Deviation|Mean
713786|NCT00220636|Secondary|Clinical Global Impressions Improvement Scale (CGI)|clinician rated improvement, score on CGI scale ranging from 1 (very much improved) to 7 (very much worse)|12 weeks|all subjects for whom data was available after beginning aripiprazole augmentation (14 of 15 subjects)||units on CGI scale||Standard Deviation|Mean
713913|NCT00224770|Primary|Safety Outcome Number 1: Rate of Mortality|Percentage of participants who died during the first 30 days after randomization.|30 days from randomization|||percentage of participants||90% Confidence Interval|Number
713914|NCT00225212|Secondary|Overall Survival (OS)||24 months|||percentage of subjects remaining alive||95% Confidence Interval|Number
713787|NCT00220636|Primary|Hamilton Depression Rating Scale (HDRS)|"Clinician rated measure of depression, mean score; this study used the 24 item version of the Hamilton Depression Rating Scale; item scores range from 0 to 4 on some items, 0 to 2 or 0 to 3 on other items; range of total score = 0 to 75, with higher score indicating worse depression Response (>50% decrease) Remission (score<=7) Outcome is the number of these subjects whose depression responded after treatment with aripiprazole, which means a 50% or greater decrease in Hamilton Depression Rating Scale scores at week 12."|12 weeks|Adults with treatment resistant depression, all subjects with data after baseline (14 of 15 subjects).||participants|||Number
713788|NCT00220701|Secondary|Beck Depression Inventory (BDI)|21 item patient rated assessment of depression symptoms, with item scores ranging from 0 to 3. Total BDI scores can range from 0 to 63, with higher scores indicating worse depression.|Week 12|||units on a scale||Standard Deviation|Mean
713789|NCT00220701|Secondary|Clinical Global Impressions - Severity (CGI-S)|Clinician rated severity, score on CGI-S scale ranging from 1 (no pathology) to 7 (extreme pathology)|Baseline|||units on a scale||Standard Deviation|Mean
713790|NCT00220701|Primary|Hamilton-Depression Rating Scale (HDRS-24 Items)|Clinician rated measure of depression, mean score; This study used the 24 item version of the Hamilton Depression Rating Scale; item scores range from 0 to 4 on some items, 0 to 2 or 0 to 3 on other items; range of total score = 0 to 75, with higher score indicating worse depression Response (>50% decrease) Remission (score<=7)|Baseline|||units on a scale||Standard Deviation|Mean
713791|NCT00220701|Secondary|Beck Depression Inventory (BDI)|21 item patient rated assessment of depression symptoms, with item scores ranging from 0 to 3. Total BDI scores can range from 0 to 63, with higher scores indicating worse depression.|Baseline|||units on a scale||Standard Deviation|Mean
713792|NCT00220701|Secondary|Clinical Global Impressions - Severity (CGI-S)|Clinician rated severity, score on CGI-S scale ranging from 1 (no pathology) to 7 (extreme pathology)|Week 12|||units on a scale||Standard Deviation|Mean
713793|NCT00220701|Primary|Hamilton-Depression Rating Scale (HDRS-24 Items)|Clinician rated measure of depression, mean score; This study used the 24 item version of the Hamilton Depression Rating Scale; item scores range from 0 to 4 on some items, 0 to 2 or 0 to 3 on other items; range of total score = 0 to 75, with higher score indicating worse depression Response (>50% decrease) Remission (score<=7)|Week 12|||units on a scale||Standard Deviation|Mean
713794|NCT00220727|Primary|Change From Baseline in Platelet Levels||24 hours Post infusion and Day 7|||Giga/L||Standard Deviation|Mean
713795|NCT00220727|Primary|Red Blood Cells|Red blood cells as a measure to assess hemolysis|24 hrs after treatment|||10^12 cells/L||Standard Deviation|Mean
713796|NCT00220727|Primary|Hematocrit|Hematocrit as a measure to assess hemolysis|24 hrs after treatment|||percentage of blood||Standard Deviation|Mean
713797|NCT00220727|Secondary|Number of Subjects With Infusion Related Adverse Events||48 hours after treatment|||participants|||Number
713798|NCT00220727|Primary|Free Hemoglobin|Free hemoglobin as a measure to assess hemolysis.|24 hours after treatment|||g/dL||Standard Deviation|Mean
713799|NCT00220740|Secondary|Time to Relapse for Subjects Who Were IGIV-C Responders or IGIV-C Rescue Successes, During the Randomized Withdrawal Period||6 months|In the Randomized Withdrawal Period, 43 subjects were randomized to IGIV-C, but only 31 out of the 41 subjects were prior IGIV-C responders or rescue successes. Similarly, 31 subjects were randomized to Placebo, but only 26 out of the 31 subjects were prior IGIV-C responders or rescue successes.||weeks||Standard Deviation|Mean
713800|NCT00220740|Secondary|Mean Change in Grip Strength During the Efficacy Period||6 months|Intent-to-treat||kilopascal||Standard Deviation|Mean
713801|NCT00220740|Secondary|Mean Change in the Amplitude (Millivolts) in the Most Severely Affected Motor Nerve During the Efficacy Period|Mean changes in amplitude [mV] measured at most proximal site in the most severely affected motor nerve from baseline to endpoint during the Efficacy Period (Intent to treat population)|6 months|Intent-to-treat||Millivolts||Standard Deviation|Mean
713802|NCT00220740|Primary|Comparison of the Responder Rates Between Two Treatment Groups in the Efficacy Period|"The primary efficacy objective was the comparison of IGIV-C and Placebo group Responder rates. An Efficacy Period Responder was defined as a subject with ≥ 1 point improvement in the adjusted Inflammatory Neuropathy Case And Treatment (INCAT) score, with the improvement maintained through the end of Week 24 in the Efficacy Period.
Measurements are reported in INCAT scale of 0-5 in both lower and upper extremities, for a total score of 0 to 10.
INCAT scores for arm disability: 0 = no upper limb problems; 5 = inability to use either arm for any purposeful movement.
INCAT scores for leg disability: 0= walking not affected; 5 = restricted to wheelchair, unable to stand and walk a few steps with help"|6 months|The Intent-to-Treat Population was defined as all randomized subjects. This population was the primary efficacy population to be analyzed.||percentage of responders|||Number
713803|NCT00220779|Primary|Percentage of Relapse Free Subjects (no Relapse)|A relapse was defined for the purposes of this study as the appearance or reappearance of one or more neurological symptoms or worsening of an old symptom attributed to multiple sclerosis (MS) persisting for at least 48 hours and immediately preceded by a relatively stable or improving neurological state of at least 30 days.|12 months|Intent-to-Treat (ITT) Population was all randomized subjects. This was the primary analysis population.||percentage of participants|||Number
713804|NCT00220779|Secondary|Effect on the Combined Unique Lesion Activity on Magnetic Resonance Imaging (MRI)||1 year||||||
713805|NCT00220805|Secondary|Mean Change From Baseline to Endpoint in Size of Lesion (Largest Dimension Relative to Disk Diameter) Assessed by Central Fluorescein Angiogram Reading Center||At end of treatment (12 weeks)|Intent to Treat||Disk Diameter||Standard Deviation|Mean
713806|NCT00220805|Secondary|Presence of Fibrosis and Location Assessed by Slit-lamp||Last measurement at or later than Week 8|Intent to Treat||participants|||Number
713807|NCT00220805|Secondary|Proportion of Subjects With an Increase ≥ 2 or More Points in Lens Opacity Classification System (LOCS III) for Nuclear Opalescence, Nuclear Color, Cortical Cataract or Posterior Subcapsular Cataract Categories|The LOCS III scale for cortical cataract and posterior subcapsular cataract opacity ranged from 1.0 to 5.0. The LOCS III scale for nuclear opalescence and for nuclear color was 1.0 to 6.0. For all scales, higher values indicate higher opacity, opalescence, or color.|Last measurement at or later than Week 8|Intent to Treat subjects with cataract||participants|||Number
713915|NCT00225212|Primary|Event-free Survival (EFS)|"Events for EFS were defined as the earlier of post-ASCT relapse or death."|24 months|||percentage of not experiencing EFS event||95% Confidence Interval|Number
713808|NCT00220805|Secondary|Mean Change in LogRAD Score From Baseline to Endpoint (RADNER Test)|The RADNER test gives not only information about the subject's reading performance, but also about the reading speed (life quality) and the faults while reading. The RADNER reading charts (1, 2, and 3) contain sentences in paragraphs having a range of print sizes starting with the largest print at the top.The subject was randomly assigned one of the RADNER charts, and the charts were different between consecutive visits. The reading distance was 25 cm. The subject's score was corrected for reading speed and errors. The range of possible logRAD scores was from 2.0 (could not read the first paragraph) to -0.2, with higher scores indicating lower reading acuity and lower scores indicating higher reading acuity.|Last measurement at or later than Week 8|Intent to Treat||LogRAD||Standard Deviation|Mean
713809|NCT00220805|Secondary|Proportion of Subjects Who Improve Visual Acuity From Baseline to Endpoint by ≥ 0.2 LogMAR||Last measurement at or later than Week 8|Intent to Treat||percentage of participants|||Number
713810|NCT00220805|Secondary|Proportion of Subjects Who Improve Visual Acuity From Baseline to Endpoint by ≥ 0.1 LogMAR||Last measurement at or later than Week 8|Intent to Treat||percentage of participants|||Number
713811|NCT00220805|Primary|Mean Change in Visual Acuity (Logarithm of the Minimum Angle of Resolution [LogMAR]) Score From Baseline for IGIV-C, 10% Compared to Placebo at Week 12 or at Last LogMAR Assessment (Conducted at or After Week 8 of the Treatment Period)|Using the LogMAR score, lower values correspond to higher visual acuity. For example, a visual acuity of 20/20 corresponds to a LogMAR value of zero (0), and a visual acuity of 20/100 corresponds to a LogMAR value of 0.7.|At Week 12 or, if the Week 12 assessment is not available, at the last LogMAR assessment conducted at or after Week 8 of the Treatment Period|The Intent-to-Treat (ITT) Population consisted of all randomized subjects who received any amount of study medication and had at least one evaluation of the primary efficacy variable (LogMAR score) at Week 8 or later and at Baseline.||LogMAR||Standard Deviation|Mean
713812|NCT00220961|Secondary|Change in Atherosclerosis|carotid intima thickness|Baseline versus 2.4 years|||percentage of intima||Standard Deviation|Mean
713813|NCT00220961|Secondary|Change From Baseline in Matsuda Index of Insulin Sensitivity (There Are no Minimum/Maximum Values)|Insulin sensitivity The Matsuda index was calculated as 10,000/square root of (pre-meal glucose x pre-meal insulin x mean 120 min post-meal glucose x mean 120 min post-meal insulin), with higher numbers indicating better the insulin sensitivity.|Baseline versus 2.4 years|||matsuda index||Standard Deviation|Mean
713814|NCT00220961|Secondary|Change From Baseline in Plasma Insulin Concentration During Oral Glucose Tolerance Test|Insulin secretion|Baseline versus 2.4 years|||nmol||Standard Deviation|Mean
713815|NCT00220961|Secondary|Change From Baseline in Fasting Plasma Glucose of 2.4 Years|Fasting Plasma Glucose|Baseline versus 2.4 years|||mg/dl||Standard Deviation|Mean
713816|NCT00220961|Primary|Prevention of Type 2 Diabetes|Percentage of Participants with Type 2 Diabetes at 2.4 years Post-randomization|2.4 years|||percentage of participants|||Number
713817|NCT00221195|Primary|Reduction in the Number of Bleeds||6 months|||bleeds||Standard Deviation|Mean
713818|NCT00221299|Primary|Bone Mineral Density (BMD): Examine the Pattern and Effect of BMD Changes at Hip and Spine Measured by DXA Every 6 Months.|In this randomized clinical trial to determine if treatment with rhPTH (1-34) with and without risedronate will increase bone mass of the lumbar spine more than risedronate alone. This was a small pilot study and study subjects were recruited from two study sites. Our primary endpoint was change in lumbar spine BMD.|BMD changes from year 1 to year 2|Per protocol||percent change||Standard Deviation|Mean
713819|NCT00215787|Primary|Presence of Reflux in Patients With Polyposis|Presence of Laryngopharyngeal reflux was measured by 24 hour pH impedance probe monitor per equipment manufacturer software. Two or more episodes in twenty four hours was considered positive, in accordance with published standards.|one year|||participants|||Number
713820|NCT00215930|Secondary|Progression Free Survival (PFS)|PFS was recorded as the time elapsed from the date of first treatment to the date of first evidence for disease progression or death. OS and PFS probabilities were estimated using the Kaplan-Meier method. For statistical purposes, it is important to note that this trial was not designed to compare outcomes among patients assigned to the different chemotherapies, but rather that molecular analysis directed individualized chemotherapy assignment is feasible and yields promising results in outcomes.|24 Months|Review of all participants for Number at risk, Number of events, Number censored.||Months||Full Range|Median
713821|NCT00215930|Secondary|Overall Survival (OS)|Median Overall Survival of Participants. OS and Progression Free Survival (PFS) probabilities were estimated using the Kaplan-Meier method. For statistical purposes, it is important to note that this trial was not designed to compare outcomes among patients assigned to the different chemotherapies, but rather that molecular analysis directed individualized chemotherapy assignment is feasible and yields promising results in outcomes.|24 Months|Review of all participants per protocol for Number at risk, Number of events, Number censored.||Months||Full Range|Median
713822|NCT00215930|Primary|Best Disease Response After a Maximum of Six Cycles.|Determine the number of participants for each category of response rates (RR) in newly diagnosed patients with advanced non-small cell lung cancer (NSCLC) who are treated with a chemotherapeutic regimen assigned to them on the basis of expression of the genes ribonucleotide reductase subunit 1 (ERCC1) and excision repair cross-complementing group 1 gene (RRM1) expression. Prior to treatment we measured the level of ERCC1 and RRM1 expression in the patients tumor, on the basis of which the patient would be assigned a specific doublet chemotherapy.|24 Months|All participants were analyzed according to Response Evaluation Criteria in Solid Tumors (RECIST).||Participants|||Number
713823|NCT00215943|Secondary|Overall Survival (OS), by Treatment Arm|"Median OS for thalidomide/Dexamethasone participants vs. VAD participants. Months from On Study to Expired/Last Date Known Alive.
Investigators had planned to accrue 176 participants to calculate median overall survival."|Up to 10 Years|All participants with evaluable follow-up data.||months||Full Range|Median
713824|NCT00215943|Secondary|Number of Participants With Progression Free Survival (PFS), by Treatment Arm|"Number of participants with PFS for thalidomide/Dexamethasone vs. VAD with respect to progression free survival in newly diagnosed MM. Progressive Disease (PD): (for patients not in CR) Requires one or more of the following; > 25% increase in the level of serum monoclonal paraprotein, which must also be an absolute increase of at least 5 g/L and confirmed on a repeat investigation.
> 25% increase in 24-hour urinary light chain excretion, which must also be an absolute increase of at least 200mg and confirmed on a repeat investigation.
>25% increase in plasma cells in a bone marrow aspirate, which also must be an absolute increase of at least 10%. Definite increase in the size of existing lytic lesions or plasmacytomas. Development of new bone lesions or plasmacytomas (except compression fractures). Development of hypercalcemia (corrected calcium > 11.5 mg/dL not attributable to other causes)."|4 Months|All evaluable participants||participants|||Number
713825|NCT00215943|Secondary|Number of Participants With Adverse Events, by Group|Number of participants with toxicities of Thalidomide/Dexamethasone vs. VAD as induction regimens in newly diagnosed multiple myeloma (MM).|4 Years, 7 Months|All evaluable participants||participants|||Number
713826|NCT00215943|Primary|Response Rates of VAD vs. Thalidomide/Dexamethasone|Blade (15) criteria for remission in multiple myeloma was used to assess response. Complete Response (CR)includes: Disappearance of the original monoclonal protein from the blood and urine on at least two determinations for a minimum of 6 weeks by immunofixation studies. Partial Response (PR) includes: At least a 50% reduction in the level of serum monoclonal protein for at least two determinations 6 weeks apart. Minimal Response (MR)includes: At least a 25% to 49% reduction in the level of serum monoclonal protein for at least 2 determinations 2 weeks apart.|End of Cycle 4 - 4 Months per Participant|All evaluable participants||participants|||Number
713827|NCT00222105|Secondary|Toxicity|Count of Participants with adverse events.|End of study, up to 12 months|||Participants|||Count of Participants
713828|NCT00222105|Primary|Overall Response Rate|Response rate after completion of first cycle. Measured as the proportion of subjects who have a partial response (PR) or complete response (CR), represented as the overall response rate (ORR). SWOG/IBMTR (Southwest Oncology Group/International Blood and Marrow Transplant Research) criteria utilized to determine multiple myeloma response rates.|At End of Cycle 1, 28 Days|Five subjects did not complete first cycle.||percentage of participants|||Number
713829|NCT00222729|Secondary|Overall Survival (OS)||Up to 36 months|Evaluable patients with previously untreated, recurrent, or metastatic SCCHN were treated with pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg||months||90% Confidence Interval|Median
713830|NCT00222729|Secondary|Disease Control Rate (DCR)||Up to 36 months|Evaluable patients with previously untreated, recurrent, or metastatic SCCHN were treated with pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg||percentage||90% Confidence Interval|Median
713831|NCT00222729|Secondary|Objective Response Rate (ORR)||Up to 36 months|Evaluable patients with previously untreated, recurrent, or metastatic SCCHN were treated with pemetrexed 500 mg/m2||percentage||90% Confidence Interval|Median
713832|NCT00222729|Primary|Time-to-progression (TTP)|TTP was calculated from treatment initiation to disease progression or last follow-up.|Up to 36 months|Evaluable patients with previously untreated, recurrent, or metastatic SCCHN were treated with pemetrexed 500 mg/m2||months||90% Confidence Interval|Median
713833|NCT00223236|Secondary|Rey Auditory Verbal Learning Test(RAVLT)|The RAVLT consists of 15 nouns read aloud for five consecutive trials with each trial followed by a free-recall trial. The total score is the total number of words recalled through the five trials. Normative RAVLT T-scores was used. the higher T score, the better memory. Exit week is defined as the last week of treatment. It varied between 2 week an 12 weeks with an average exit week of 10 week and 7 week for the citicoline treatment and placebo groups, respectively. Allowing unequal week of treatment period in measuring outcome enables us to include most participants due to a low retention rate in the end of the study period, 12 weeks. The outcome was measured by change in RAVLT T scores between baseline and exit (exit - baseline).|Change in T scores between baseline and exit (exitT score - baseline T score).|number of participants are calculated based on those who completed baseline and at least one treatment visit.||T score||Standard Deviation|Mean
713834|NCT00223236|Secondary|Young Mania Rating Scale(YMRS).|The YMRS questionnaire has 11 items with scale range 0 to 4 for 7 items and 0 to 8 for 4 items. 0=normal and and 4 or 8 =most abnormal. The total possible score is 0 to 60, 0 being no symptom and 60 the worst symptom. The higher the score, the worse the mania symptoms are. Exit week is defined as the last week of treatment. It varied between 2 week an 12 weeks with an average exit week of 10 week and 7 week for the citicoline treatment and placebo groups, respectively. Allowing unequal week of treatment period in measuring outcome enables us to include most participants due to a low retention rate in the end of the study period, 12 weeks. The outcome was measured by change in scores between baseline and exit (exit - baseline).|Baseline to exit (exit score - baseline score)|Numbers of participants are those who completed baseline assessment and at least one treatment visit.||units on a scale||Standard Deviation|Mean
713835|NCT00223236|Secondary|Inventory of Depressive Symptomatology Self Report (IDS-SR).|The IDS-SR is a 30 item self report used to assess the severity of depressive symptoms. The each item has a 4-likert scale, 0 to 3, with 3 representing the worst symptom. The total score of IDS-SR is calculated as a sum of each item score. The range of possible score is between 0 and 90, 0 as no symptom and 90 the worst symptom. The higher the score, the more severe the depression. Exit week is defined as the last week of treatment. It varied between 2 week an 12 weeks with an average exit week of 10 week and 7 week for the citicoline treatment and placebo groups, respectively. Allowing unequal week of treatment period in measuring outcome enables us to include most participants due to a low retention rate in the end of the tudy period, 12 weeks. The outcome was measured by change in scores between baseline and exit (exit - baseline).|Change in scores between baseline and exit (exit - baseline).|Number of participants reported are those who completed baseline assessment and at least one treatment visit.||units on scale||Standard Deviation|Mean
713851|NCT00223808|Secondary|Change in FIM Score at 6-months|Change in FIM score at 6-months from study enrollment compared to baseline. Maximum score = 63|Change in FIM score at 6-months from study enrollment compared to baseline FIM prior to study intervention, which began between 7 and 21 days post-stroke.|A total of 37 subjects returned for the 6-month follow-up evaluations.||units on a scale||Standard Error|Mean
713916|NCT00225251|Secondary|Global Assessment of Functioning Scale (GAFS)|A clinician rated assessment of patient's overall functioning, ranging from 0 (severely impaired) to 100 (excellent functioning)|10 weeks|||units on a scale||Standard Deviation|Mean
713836|NCT00223236|Primary|Cocaine Use Determined by Urine Analysis|Urine drug screens were administered at each visit to detect cocaine in urine. If negative according to urine analysis, it is determined as no cocaine use and if positive, cocaine use. Percentage of participants with no cocaine detected in urine at exit is an outcome measuring treatment effectiveness. Exit week is defined as the last week of treatment. It varied between 2 week an 12 weeks with an average exit week of 10 week and 7 week for the citicoline treatment and placebo groups, respectively. Allowing unequal week of treatment period in measuring outcome enables us to include most participants due to a low retention rate in the end of the study period, 12 weeks.|Biweekly (visit) urine drug screens|Number of participants are those who completed baseline assessment and at least one treatment visit followed by baseline.||percentage of participants no cocaine|||Number
713837|NCT00223496|Primary|Primary Measure:Reduction in Depression Symptoms|Primary efficacy will be assessed by the proportion of patients achieving a 50% reduction (range 0- 60, higher the number the more depressed) on the Montgomery Asberg Depression Rating Scale (MADRS) (defined as response) concomitant with a Clinical Global Impression Scale(CGI-S) improvement of 1 or 2 (range 0-7, higher the number the more severe the overall bipolar symptoms).|up to 12 weeks|||participants|||Number
713838|NCT00223652|Secondary|Number of Participants Meeting Criteria for Major Depression Disorder at 6 Month Follow-up|"Veterans meeting criteria for major depressive disorder were randomized to receive 16 session of T-CBT over 20 weeks or treatment as usual through the CBOC. Generalized estimating equations models with exchangeable working correlation structure was used for the binary outcome (MDE).
A veteran was required to meet diagnostic criteria for severe psychiatric disorder(e.g., psychotic, bipolar, or dementia disorder; post-traumatic stress disorder [PTSD] patients were not excluded). DSM-IV diagnosis was assessed using the full Mini International Neuropsychiatric Interview at baseline, whereas the major depressive episode(MDE) module was administered at follow-up."|6-month follow up at week 44 post treatment|||participants|||Number
713839|NCT00223652|Secondary|Maintenance of Treatment Effect|"6-month post treatment follow-up on outcome measure of the Patient Health Questionnaire-9 (PHQ-9).
Data was analyzed using a mixed-effects repeated measures model with random subject-specific intercepts for continuous outcome PHQ-9.
PHQ-9 score ranges from 0-27, higher values indicate more severe depression. PHQ-9 scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe and severe depression, respectively."|6-month post treatment follow-up|||units on a scale||Standard Deviation|Mean
713840|NCT00223652|Primary|Number of Participants Meeting Criteria for Major Depressive Disorder|Veterans meeting criteria for major depressive disorder were randomized to receive 16 session of T-CBT over 20 weeks or treatment as usual through the CBOC. Generalized estimating equations models with exchangeable working correlation structure was used for the binary outcome (MDE). A veteran was required to meet diagnostic criteria for severe psychiatric disorder(e.g., psychotic, bipolar, or dementia disorder; post-traumatic stress disorder [PTSD] patients were not excluded). DSM-IV diagnosis was assessed using the full Mini International Neuropsychiatric Interview at baseline, whereas the major depressive episode(MDE) module was administered at follow-up.|Baseline to week 12, and week 20|||participants|||Number
713841|NCT00223652|Primary|Change in Severity of Depression Using the Patient Health Questionnaire-9|"Self-reported depression was measured using the Patient Health Questionnaire-9 (PHQ-9).
Data across the three time points (baseline, Week 12, Week 20) were analyzed using a mixed-effects repeated measures model with random subject-specific intercepts for continuous outcome PHQ-9. PHQ-9 scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe and severe depression, respectively.
PHQ-9 score ranges from 0-27, higher values indicate more severe depression."|Baseline, Week 12, Week 20|||units on a scale||Standard Deviation|Mean
713842|NCT00223652|Secondary|Maintenance of Treatment Effect|"Evaluators administered the Hamilton Depression Rating Scale(Ham-D). Veterans were assessed at baseline,12 weeks, 20 weeks(post treatment), and 6-month follow-up using the Ham-D.Data was analyzed using a mixed-effects repeated measures model with random subject-specific intercepts for continuous outcome Ham-D.
Ham-D ranges from 0-52, higher values indicate more severe depression. A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression."|6 month follow-up (week 44)|||units on a scale||Standard Deviation|Mean
713843|NCT00223652|Primary|Change in Severity of Depression Using Hamilton Depression Rating Scale|"Evaluators administered the Hamilton Depression Rating Scale(Ham-D).
Veterans were assessed at baseline,12 weeks, 20 weeks(posttreatment), and 6-month follow-up using the Ham-D. Self-reported depression was measured using the Hamilton Depression Rating Scale(Ham-D).
Data across the three time points (baseline, Week 12, Week 20) were analyzed using a mixed-effects repeated measures model with random subject-specific intercepts for continuous outcome Ham-D.
Ham-D ranges from 0-52, higher values indicate more severe depression. A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression."|Baseline, 12 weeks, 20 weeks|||units on a scale||Standard Deviation|Mean
713844|NCT00223678|Primary|Graft Survival||3 years|||participants||95% Confidence Interval|Median
713845|NCT00223704|Secondary|Fibrinolytic Response as Measured by D-dimer|D-dimer concentrations were measured at baseline, 30min and 60min of bypass, post-bypass and postoperative day 1|Patients were followed from the start of surgery until postoperative day 1|||ng/ml||Standard Error|Mean
713846|NCT00223704|Secondary|Inflammatory Response as Measured by Interleukin-6|Interleukin-6 was measured at baseline, post-bypass and on postoperative day 1 and 2.|Patients were followed from the start of surgery until postoperative day 2|||pg/ml||Standard Error|Mean
713847|NCT00223704|Secondary|Units of Plasma Transfused During Hospitalization|Units of plasma transfused|Patients were followed for the duration of hospital stay, an average of 6 days|||units||Standard Error|Mean
713848|NCT00223704|Secondary|Units of Packed Red Blood Cells Transfused During Hospitalization|Units of Packed Red Blood Cells Transfused|Patients were followed for the duration of hospital stay, an average of 6 days|||units||Standard Error|Mean
713849|NCT00223704|Primary|Allogenic Blood Product Transfusion Risk|Blood product transfusion during hospitalization that included packed red blood cells, plasma, platelets and cryoprecipitate.|Patients were followed for the duration of hospital stay, an average of 6 days|||percentage of participants|||Number
713875|NCT00224042|Primary|Baseline Hemoglobin Concentration||Baseline|||g/dL||Standard Deviation|Mean
713876|NCT00224055|Secondary|Change in Serum Ferritin|Change from baseline to 7 weeks after 4 consecutive weekly Ferrlecit 250 mg intravenious infusion and change from baseline to 4 weeks after 6 weeks oral ferrous sulfate 325 mg tablets t.i.d.|Baseline to 10 weeks|Modified ITT with LOCF imputation||ng/mL||Standard Deviation|Mean
713852|NCT00223808|Secondary|Change in FIM Score Immediately Following Study Intervention.|Change in the upper limb portion of the Functional Independence Measure (FIM) was assessed to determine treatment impact on independence in activities of daily living (ADL). The FIM indicates the level of disability based on how much assistance is required for an individual to carry out ADL. It can be used to assess13 motor and 5 cognitive tasks, each rated on a 7 point ordinal scale (0 = total assistance or complete dependence; 7 = complete independence in the task). Tasks include For this study, a subset of 9 tasks involving the upper limbs was used (maximum score = 63). A greater change represents a greater improvement in independence carrying out tasks requiring functional use of the upper limbs.|After study intervention (on completion of the maximum planned number of sessions for each group or discharge from inpatient rehabilitation, whichever came first) compared to baseline at study enrollment between 7 and 21 days post-stroke.|||units on a scale||Standard Error|Mean
713853|NCT00223808|Primary|Fugl-Meyer Score Change at 6 Months|Change in Fugl-Meyer score at 6-months from study enrollment compared to baseline. Maximum score = 66.|FMA at 6 months from study enrollment compared to baseline FMA performed prior to study intervention, which began between 7 and 21 days post-stroke.|A total of 37 subjects returned for the 6-month follow-up evaluations.||units on a scale||Standard Error|Mean
713854|NCT00223808|Primary|Fugl-Meyer Score Change Immediately Following Study Intervention.|Change in Fugl-Meyer Assessment (FMA) score. The FMA evaluates motor function, sensation, balance, and joint function in hemiplegic patients and provides a cumulative numerical score. It is widely used to evaluate changes in function over time in clinical care and therapeutic trials following stroke. Five domains can be assessed, including motor function (upper and lower limbs); sensory function; balance; joint range of motion; and joint pain. Items within each domain are scored on a 3-point ordinal scale: 0 = cannot perform; 1 = performs partially; and 2 = performs fully. Subscales can be administered without the using the full test. For the upper limb motor function subscale used in this clinical trial, 33 items were evaluated, each rated on a 3-point scale (0-2), then summed for a maximum possible score of 66. A greater increase in the score represents a greater improvement in upper limb motor function.|After study intervention (on completion of the maximum planned number of sessions for their group or discharge from inpatient rehabilitation, whichever came first) compared to baseline at study enrollment between 7 and 21 days post-stroke.|||units on a scale||Standard Error|Mean
713855|NCT00223821|Secondary|Change in Incontinent Episodes at 12-month Follow-up|Percent change from baseline in weekly frequency of incontinent episodes at 12-months post-treatment, derived from baseline and 12-month seven-day bladder diaries|Baseline and 12 months post-treatment|Intention to treat||percent change||Standard Deviation|Mean
713856|NCT00223821|Primary|Change in Incontinent Episodes Immediately Post-treatment|Percent change from baseline in weekly frequency of incontinent episodes immediately post-treatment, derived from baseline and week 8 seven-day bladder diaries.|Baseline and immediately post-treatment - week 8|Intention to treat||percentage change||Standard Deviation|Mean
713857|NCT00223977|Secondary|Responders by Treatment Group|Patients were classified as responders to treatment if they had an increase in Hgb of at least 1.0 g/dL assessed at 2 weeks following the final administration of Ferrlecit or 1 week following the last dose of oral iron.|Baseline to 5 weeks and 9 weeks|||participants|||Number
713858|NCT00223977|Secondary|Change From Baseline in Serum Ferritin.|Change from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection|Baseline to 5 weeks and 9 weeks|||ng/mL||Standard Deviation|Mean
713859|NCT00223977|Secondary|Change From Baseline in Transferrin Saturation (TSAT).|Change from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection|Baseline to 5 weeks and 9 weeks|||percent||Standard Deviation|Mean
713860|NCT00223977|Secondary|Change From Baseline in Hematocrit (Hct)|Change from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection|Baseline to 5 weeks and 9 weeks|||percent||Standard Deviation|Mean
713861|NCT00223977|Primary|Hemoglobin|Change from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection|Baseline to 5 weeks and 9 weeks|modified intent to treat (mITT) with last observation carried forward (LOCF) imputation||ng/mL||Standard Deviation|Mean
713862|NCT00224003|Primary|Transferrin Saturation|Change from baseline to 2 weeks after last dose|14 weeks|Per protocol (completer) population||%||Standard Deviation|Mean
713863|NCT00224003|Secondary|Evaluate the Effect of Intravenous Administration of Ferrlecit on Hematology Parameteres, on EPO Dose, and Safety.||14 weeks||||||
713864|NCT00224003|Primary|Serum Ferritin|Change from baseline to 2 weeks after last Fe dose|14 weeks|Per protocol (completer) population||ng/mL||Standard Deviation|Mean
713865|NCT00224016|Secondary|Urine Volume After First Awakening|Change from baseline in average volume of urine collected after first morning awakening|14 weeks||||||
713866|NCT00224016|Secondary|Catheterizations Without Leakage|Percentage of catherizations without leakage|14 weeks|mITT, LOCF||% of participants||Standard Deviation|Mean
713867|NCT00224016|Primary|Average Catheterization Urine Volume|Change from baseline in average volume of urine collected by catheterization|14 weeks|Modified intent-to-treat (mITT) population, Last Observation Carried Forward (LOCF) imputation||mL||Standard Deviation|Mean
713868|NCT00224029|Secondary|Urinary Leakage and Catheterization Data||8 weeks||||||
713869|NCT00224029|Secondary|Urodynamic Measurements||8 weeks||||||
713870|NCT00224029|Secondary|Patch Adhesion||8 weeks||||||
713871|NCT00224029|Primary|Average Number of Catheterizations Without Leaking Per Day|Baseline in number of daily catheterizations without leaking per day as recorded in a 3-day urinary diary.|8 weeks|The number of participants for analysis is determined by Last Observation Carried Forward (LOCF.||Number of Dry Catheterizations per Day||Standard Deviation|Mean
713872|NCT00224042|Secondary|Change in Serum Ferritin|Change from baseline to 7 weeks after 4 consecutive weekly Ferrlecit 250 mg intravenious infusion and change from baseline to 4 weeks after 6 weeks oral ferrous sulfate 325 mg tablets t.i.d.|Baseline to 10 weeks|Modified ITT with LOCF imputation||ng/mL||Standard Deviation|Mean
713873|NCT00224042|Primary|Change in Hemoglobin (Hgb)|Change from baseline to 7 weeks after 4 consecutive weekly Ferrlecit 250 mg intravenious infusion and change from baseline to 4 weeks after 6 weeks oral ferrous sulfate 325 mg tablets t.i.d.|Baseline to 10 weeks|Modified ITT with LOCF imputation||g/dL||Standard Deviation|Mean
713874|NCT00224042|Secondary|Baseline Serum Ferritin Concentration||Baseline|||ng/mL||Standard Deviation|Mean
713881|NCT00224120|Primary|Measuring Change From Baseline in International Prostate Symptom Score (IPSS) at 12 Weeks|International prostate symptom score: Measuring prostate signs and symptoms asociated with benign prostatic hyperplasia on a 0 to 35 scale; 0 best, 35 worst symptoms|Baseline and 12 weeks|The number of participants for analysis is determined by Last Observation Carried Forward (LOCF).||Units on a scale||Standard Deviation|Mean
713882|NCT00224133|Secondary|International Prostate Symptom Score (IPSS)|The IPSS is a symptom severity scale from 0 to 35 that is derived from a 7 item questionnaire. 0 indicates no symptoms and 35 indicates most severe symptoms.|9 months||03/2010||||
713883|NCT00224133|Primary|Adverse Events|All reported adverse events were recorded. Clinically significant abnormal laboratory values or other clinical findings upon examination were also recorded as adverse events.|9 months|Safety population was analyzed. This population is defined as all enrolled patients who received at least one dose of study drug.||participants|||Number
713884|NCT00224289|Primary|Post-Treatment IOP (Intraocular Pressure)|Subjects applied topical latanoprost at bedtime for 8 weeks|8 Weeks|||mm Hg||Standard Deviation|Mean
713885|NCT00224289|Primary|Pre-Treatment IOP (Intraocular Pressure)|Subjects applied topical latanoprost at bedtime for 8 weeks|At baseline (before treatment)|||mm Hg||Standard Deviation|Mean
713886|NCT00224484|Secondary|Anti-deacylated Monophosphoryl Lipid A (Anti-MPL) Antibody Concentrations|"Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EU/mL).
The subset of subjects used for this analysis was 50% of the pre-defined subset of subjects that underwent assessment of biochemical and hematological parameters."|At months 0, 7 and 12|The analyses were performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects included in the immunogenicity subset for whom data concerning immunogenicity outcome measures were available (for whom assay results were available for antibodies against the study vaccine antigen component after Vaccination).||EU/mL||95% Confidence Interval|Geometric Mean
713887|NCT00224484|Secondary|Anti-glycoprotein D (Anti-gD) Antibody Concentrations|"Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EU/mL).
Analysis was based on an immunogenicity subset, stratified by initial serostatus: HSV seronegative (-)/ seropositive (+), this included gD2-AS04 vaccine recipients, as follows: HSV 1 and HSV 2 seronegative (HSV1-/2-) and HSV 1 seropositive and HSV 2 seronegative (HSV1+/2-)"|At months 0, 7 and 12|The analyses were performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects included in the immunogenicity subset for whom data concerning immunogenicity outcome measures were available (for whom assay results were available for antibodies against the study vaccine antigen component after Vaccination).||EU/mL||95% Confidence Interval|Mean
713888|NCT00224484|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|"Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
For outcomes covering the ESFU period, the Havrix Group and Saline Group were pooled."|Up to month 18 (during active phase and ESFU period)|The analyses were performed on the Total Vaccinated cohort, which included all subjects who received at least one dose of the study vaccine and for whom data were available.||Subjects|||Number
713889|NCT00224484|Secondary|Number of Subjects With New Onset Chronic Diseases (NOCD)|NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. For outcomes covering the ESFU period, the Havrix Group and Saline Group were pooled.|During the Extended Safety Follow Up (ESFU) period (Month 12 to Month 18)|The analyses were performed on the Total Vaccinated cohort, which included all subjects who received at least one dose of the study vaccine and for whom data were available.||Subjects|||Number
713890|NCT00224484|Secondary|Number of Subjects With Medically Significant Conditions (MSC)|"MSCs include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
For outcomes covering the ESFU period, the Havrix Group and Saline Group were pooled."|During the Extended Safety Follow Up (ESFU) period (Month 12 to Month 18)|The analyses were performed on the Total Vaccinated cohort, which included all subjects who received at least one dose of the study vaccine and for whom data were available.||Subjects|||Number
713891|NCT00224484|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs) With Medically Attended Visits|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. A medically attended visit is an event which prompted the subject to seek medical advice.|Starting from Day 30 until the end of study (Month 18)|The analyses were performed on the Total Vaccinated cohort, which included all subjects who received at least one dose of the study vaccine and for whom data were available.||Subjects|||Number
713892|NCT00224484|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed|Assessed parameters were alanine aminotransferase (ALT), creatinine (CREA), haematocrit (Hct), platelets (PLA), red blood cells (RBC), urea and white blood cells (WBC). A subset of subjects was formed for these analyses. Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range at other timepoints. This outcome presents WBC results.|At months 0, 7 and 12|The analyses were performed on the Total Vaccinated cohort, which included all subjects who received at least one dose of the study vaccine and for whom data were available.||Subjects|||Number
713917|NCT00225251|Secondary|Clinical Global Improvement (CGI)|A global assessment of patient improvement, ranging from 1 (very much improved) to 7 (very much worse)|10 weeks|||units on a scale||Standard Deviation|Mean
713918|NCT00225251|Secondary|Beck Depression Inventory (BDI)|21 item patient rated assessment of depression symptoms, with item scores ranging from 0 to 3. Total BDI scores can range from 0 to 63, with higher scores indicating worse depression.|10 weeks|||units on a scale||Standard Deviation|Mean
713919|NCT00225251|Secondary|Cornell Dysthymia Rating Scale (CDRS)|A 24 item scale assessing symptoms of chronic depression. Scores from 0 to 96 with higher score indicating worse depression|10 weeks|||units on a scale||Standard Deviation|Mean
713893|NCT00224484|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed|Assessed parameters were alanine aminotransferase (ALT), creatinine (CREA), haematocrit (Hct), platelets (PLA), red blood cells (RBC), urea and white blood cells (WBC). A subset of subjects was formed for these analyses. Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range at other timepoints. This outcome presents UREA results.|At months 0, 7 and 12|The analyses were performed on the Total Vaccinated cohort, which included all subjects who received at least one dose of the study vaccine and for whom data were available.||Subjects|||Number
713894|NCT00224484|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed|Assessed parameters were alanine aminotransferase (ALT), creatinine (CREA), haematocrit (Hct), platelets (PLA), red blood cells (RBC), urea and white blood cells (WBC). A subset of subjects was formed for these analyses. Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range at other timepoints. This outcome presents RBC results.|At months 0, 7 and 12|The analyses were performed on the Total Vaccinated cohort, which included all subjects who received at least one dose of the study vaccine and for whom data were available.||Subjects|||Number
713895|NCT00224484|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed|Assessed parameters were alanine aminotransferase (ALT), creatinine (CREA), haematocrit (Hct), platelets (PLA), red blood cells (RBC), urea and white blood cells (WBC). A subset of subjects was formed for these analyses. Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range at other timepoints. This outcome presents PLA results.|At months 0, 7 and 12|The analyses were performed on the Total Vaccinated cohort, which included all subjects who received at least one dose of the study vaccine and for whom data were available.||Subjects|||Number
713896|NCT00224484|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed|Assessed parameters were alanine aminotransferase (ALT), creatinine (CREA), haematocrit (Hct), platelets (PLA), red blood cells (RBC), urea and white blood cells (WBC). A subset of subjects was formed for these analyses. Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range at other timepoints. This outcome presents Hct results.|At months 0, 7 and 12|The analyses were performed on the Total Vaccinated cohort, which included all subjects who received at least one dose of the study vaccine and for whom data were available.||Subjects|||Number
713897|NCT00224484|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed|Assessed parameters were alanine aminotransferase (ALT), creatinine (CREA), haematocrit (Hct), platelets (PLA), red blood cells (RBC), urea and white blood cells (WBC). A subset of subjects was formed for these analyses. Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range at other timepoints. This outcome presents CREA results.|At months 0, 7 and 12|The analyses were performed on the Total Vaccinated cohort, which included all subjects who received at least one dose of the study vaccine and for whom data were available.||Subjects|||Number
713898|NCT00224484|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed|Assessed parameters were alanine aminotransferase (ALT), creatinine (CREA), haematocrit (Hct), platelets (PLA), red blood cells (RBC), urea and white blood cells (WBC). A subset of subjects was formed for these analyses. Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range at other timepoints. This outcome presents ALT results.|At months 0, 7 and 12|The analyses were performed on the Total Vaccinated cohort, which included all subjects who received at least one dose of the study vaccine and for whom data were available.||Subjects|||Number
713899|NCT00224484|Secondary|Number of Subjects With New Onset Chronic Diseases (NOCD)|NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.|During the active phase (up to Month 12)|The analyses were performed on the Total Vaccinated cohort, which included all subjects who received at least one dose of the study vaccine and for whom data were available.||Subjects|||Number
713900|NCT00224484|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs) With Medically Attended Visits|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. A medically attended visit is an event which prompted the subject to seek medical advice.|Within the 30 Day (Day 0-29) post-vaccination period|The analyses were performed on the Total Vaccinated cohort, which included all subjects who received at least one dose of the study vaccine and for whom data were available.||Subjects|||Number
713920|NCT00225251|Primary|Hamilton Depression Rating Scale, 24 Items (HDRS)|"Widely used depression rating scale, with higher scores reflecting greater level of depression. Assesses suicidality which is a safety issue.
This study used the 24 item version of the Hamilton Depression Rating Scale; item scores range from 0 to 4 on some items, 0 to 2 or 0 to 3 on other items; range of total score = 0 to 75, with higher score indicating worse depression Response (>50% decrease) Remission (score<=7)"|10 weeks|||units on a scale||Standard Deviation|Mean
714108|NCT00229957|Secondary|Independence in Activities of Daily Living (ADLs) and Instrumental Activities of Daily Living (IADLs)|Late Life Function and Disability Instrument: A measure of disability and functional limitations in older adults. (Score range 0-100 with 100 representing better ability and less disability/functional limitation)|baseline, 15 months||08/2009||||
713901|NCT00224484|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 = event which prevented normal, everyday activities. In adults/ adolescents, such an AE would, for example, prevent attendance at work/ school and would necessitate the administration of corrective therapy. Related = event assessed by the investigator as causally related to study vaccination.|Within 30 days (Day 0-29) after any vaccination|The analyses were performed on the Total Vaccinated cohort, which included all subjects who received at least one dose of the study vaccine and for whom data were available.||Subjects|||Number
713902|NCT00224484|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, headache, malaise, rash, temperature [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)] and urticaria. Any = occurrence of any general symptom regardless of intensity grade or relation to vaccination. Grade 3 arthralgia, fatigue, headache, malaise, rash = general symptom that prevented normal activity. Grade 3 temperature = greater than 39 degrees Celsius (°C). Grade 3 urticaria = urticaria distributed on at least 4 body areas. Related = general symptom assessed by the investigator as causally related to the study vaccination.|Within 7 days (Days 0-6) after each and any vaccination|The analyses were performed on the Total Vaccinated cohort, which included all subjects who received at least one dose of the study vaccine and for whom data were available.||Subjects|||Number
713903|NCT00224484|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activities. Grade 3 redness/swelling = greater than (>) 30mm diameter and persisting more than 24 hours.|Within 7 days (Days 0-6) after each and any vaccination|The analyses were performed on the Total Vaccinated cohort, which included all subjects who received at least one dose of the study vaccine and for whom data were available.were||Subjects|||Number
713904|NCT00224484|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Month 0 to Month 12|The analyses were performed on the Total Vaccinated cohort, which included all subjects who received at least one dose of the study vaccine and for whom data were available.||Subjects|||Number
713905|NCT00224770|Primary|Efficacy Outcome Number 1: Dichotomized Modified Rankin Scale (mRS) at Day 180|Percentage of participants with dichotomized mRS score in 0-3 range. The mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale ranges from 0-6: (0) no symptoms at all, (1) no significant disability despite symptoms; able to carry out all usual duties and activities, (2) slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance, (3) moderate disability; requiring some help, but able to walk without assistance, (4) moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance, (5) severe disability; bedridden, incontinent and requiring constant nursing care and attention, (6) dead|180 days from randomization|||percentage of participants||90% Confidence Interval|Number
713906|NCT00224770|Secondary|Post-operative Clot Size Reduction|The percentage of blood clot resolved by the end of treatment CT scan compared to the post-operative CT scan for surgical patients.|Time from post-operation until end of treatment, up to 10 days|Analysis population only includes surgical patients.||percentage of blood clot resolved||Inter-Quartile Range|Median
713907|NCT00224770|Secondary|Clot Size Reduction by End of Treatment|The percentage of blood clot resolved by the end of treatment CT scan compared to the stability CT scan.|Time from randomization until end of treatment, up to 10 days|||percentage of blood clot resolved||Inter-Quartile Range|Median
713908|NCT00224770|Secondary|Ordinal Modified Rankin Scale (mRS) at Day 365|Ordinal distribution of the Modified Rankin Scale score at 365 days. The mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale ranges from 0-6: (0) no symptoms at all, (1) no significant disability despite symptoms; able to carry out all usual duties and activities, (2) slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance, (3) moderate disability; requiring some help, but able to walk without assistance, (4) moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance, (5) severe disability; bedridden, incontinent and requiring constant nursing care and attention, (6) dead.|365 days from randomization|||units on a scale||Inter-Quartile Range|Median
713909|NCT00224770|Secondary|Ordinal Modified Rankin Scale (mRS) at Day 180|Ordinal distribution of the Modified Rankin Scale score at 180 days. The mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale ranges from 0-6: (0) no symptoms at all, (1) no significant disability despite symptoms; able to carry out all usual duties and activities, (2) slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance, (3) moderate disability; requiring some help, but able to walk without assistance, (4) moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance, (5) severe disability; bedridden, incontinent and requiring constant nursing care and attention, (6) dead.|180 days from randomization|||units on a scale||Inter-Quartile Range|Median
713910|NCT00224770|Primary|Safety Outcome Number 4: Rate of Symptomatic Rebleeding|The difference in the rate of symptomatic rebleeding 72 hours post last dose.|72 hours post last dose|||percentage of participants||90% Confidence Interval|Number
713911|NCT00224770|Primary|Safety Outcome Number 3: Rate of Cerebritis, Meningitis, Bacterial Ventriculitis|Percentage of participants who had a bacterial brain infection (cerebritis, meningitis, ventriculitis) within 30 days of randomization.|30 days from randomization|||percentage of participants||90% Confidence Interval|Number
713912|NCT00224770|Primary|Safety Outcome Number 2: Rate of Procedure-related Mortality|Percentage of participants who died during the first 7 days after randomization.|7 days from randomization|||percentage of participants||90% Confidence Interval|Number
713921|NCT00225277|Other Pre-specified|Number of Cardiovascular Events as Adjudicated by the Clinical Endpoint Committee|The incidence of cardiovascular events and composite endpoints occurring within 30 days of last dose as adjudicated by the Clinical Endpoint Committee. Abbreviations: PCI: Percutaneous Coronary Intervention; CABG: Coronary Artery Bypass Graft; CHF: Congestive Heart Failure.|Up to 72 weeks|Safety Population||Number of Events|||Number
713922|NCT00225277|Secondary|Number of Subjects Experiencing Any of the Composite Endpoint C Cardiovascular Events|Due to low event rates, number of subjects experiencing any of the composite endpoint C cardiovascular events is being reported instead of time to first occurrence. Endpoint C conditions listed in Limitations and Caveats section.|Up to 72 weeks|Kaplan-Meier methodology was used to estimate time to event for each composite endpoint. P-value comparing survival function between groups was based on log-rank test. Time to first occurrence of cardiovascular events/hospitalizations had non-estimable medians due to very low event rates. Number of participants experiencing events are presented.||participants|||Number
713923|NCT00225277|Secondary|Number of Subjects Experiencing Any of the Composite Endpoint B Cardiovascular Events|Due to low event rates, number of subjects experiencing any of the composite endpoint B cardiovascular events is being reported instead of time to first occurrence. Endpoint B conditions listed in Limitations and Caveats section.|Up to 72 weeks|Kaplan-Meier methodology was used to estimate time to event for each composite endpoint. P-value comparing survival function between groups was based on log-rank test. Time to first occurrence of cardiovascular events/hospitalizations had non-estimable medians due to very low event rates. Number of participants experiencing events are presented.||Participants|||Number
713924|NCT00225277|Secondary|Number of Subjects Experiencing Any of the Composite Endpoint A Cardiovascular Events|Due to low event rates, number of subjects experiencing any of the composite endpoint A cardiovascular events is being reported instead of time to first occurrence. Endpoint A conditions listed in Limitations and Caveats section.|Up to 72 weeks|Kaplan-Meier methodology was used to estimate time to event for each composite endpoint. P-value comparing survival function between groups was based on log-rank test. Time to first occurrence of cardiovascular events/hospitalizations had non-estimable medians due to very low event rates. Number of participants experiencing events are presented.||Participants|||Number
713925|NCT00225277|Secondary|Nominal Change From Baseline in Normalized Total Atheroma Volume|The nominal change in normalized total atheroma volume as measured by the average of plaque areas for all slices of anatomically comparable segments of the target coronary artery multiplied by the mean number of matched slices in the population. Assessment completed at the Week 72 visit or Final Visit if treatment was prematurely discontinued.|Baseline and Final Visit (up to 72 weeks)|N at baseline included subjects who had both a baseline value and a final visit value. Baseline value is the last observation before first dose of study medication.||Percent volume||Standard Error|Least Squares Mean
713926|NCT00225277|Primary|Nominal Change From Baseline in Percent Atheroma Volume|The nominal change from baseline in percent atheroma volume for all slices of anatomically comparable segments of the target coronary artery. Assessment completed at the Week 72 visit or Final Visit if treatment was prematurely discontinued.|Baseline and Final Visit (up to 72 weeks)|N at baseline included subjects who had both a baseline value and a final visit value. Baseline value is the last observation before first dose of study medication.||Percent volume||Standard Error|Least Squares Mean
713927|NCT00225420|Secondary|Biochemical Progression-free Survival (PFS)|Measure of the activity of a treatment on a disease. In this study it is measured from the date of enrollment to the date on which the prostate cancer progresses or the date the patient dies. Survival curves were estimated using the Kaplan-Meier technique. Biochemical (PSA) failure is defined, in accordance to the American Society for Therapeutic Radiology and Oncology consensus definition, as three consecutive rise in PSA. The date of biochemical failure is considered to be the midpoint between the last non-rising PSA and the first rising PSA.|Average follow up of 2 years|||percentage of patients||95% Confidence Interval|Mean
713928|NCT00225420|Primary|Number of Patients Experiencing Dose-Limiting Toxicities|Determine the number of patients experiencing dose-limiting toxicities (DLT) at each dose level. DLT was defined as grade 3-4 non-haematological or grade 4 haematological toxicity, using the Common Terminology Criteria for Adverse Events, version 3.0.|Average follow up of 2 years|||Participants|||Count of Participants
713929|NCT00225498|Primary|Working Memory|"California Verbal Learning Test (CVLT) trials 1 through 5 is a well established neuropsychological test of working memory. The maximum score is 80 which reflects a better outcome and the minimum score is 0 which reflects a worse outcome.
The only meaningful analyses with adequate statistical power that could be reported were of the 10 schizophrenia patients who met nonresponse criteria to ziprasidone. The overall enrollment of 35 subjects was insufficient to perform the originally planned analyses in a statistically valid manner."|3 months|The only meaningful analyses with adequate statistical power that could be reported were of the 10 schizophrenia patients who met nonresponse criteria to ziprasidone. The overall enrollment of 35 subjects was insufficient to perform the originally planned analyses in a statistically valid manner.||units on a scale||Standard Deviation|Mean
713930|NCT00225732|Primary|Change in the Patient Demand for the Narcotic Analgesic, Morphine, Post Surgery|Change in the amount of morphine use (in milligrams) by subjects in each treatment group for a 24 hour period post-surgery|24 Hours|||milligrams||Standard Error|Least Squares Mean
713931|NCT00225784|Secondary|Pattern of Failure After Therapy|Local recurrence, distant recurrence, or both.|Five years post treatment|All participants who completed treatment and underwent resection||participants|||Number
713932|NCT00225784|Secondary|Overall Length of Survival After Therapy|Length of survival after therapy in all participants enrolled.|Five years post treatment|All participants enrolled regardless of evaluability for primary outcome measure.||months||Full Range|Median
713933|NCT00225784|Secondary|Disease-Free Survival After Therapy|Time to disease progression after therapy.|Five years post treatment|All evaluable participants who completed treatment, and had confirmed progression of disease.||months||Full Range|Median
713934|NCT00225784|Secondary|Role of Epidermal Growth Factor Receptor (EGFR) Status in Response to Treatment.|Tumor was assessed for EGFR status by immunohistochemistry. EGFR positive and EGRF negative tumor types were evaluated and compared for response to treatment.|One month post-therapy|All EGFR (-) subjects who completed therapy were evaluated.||percent|||Number
714109|NCT00229957|Secondary|Use of Hospital Services|self report use of hospital service|baseline, 15 months||07/2009||||
714110|NCT00229957|Primary|SF-36 Physical Component|health related quality of life. Minimum: 0; Maximum 100.|15 months|||units on a scale||Standard Deviation|Mean
713935|NCT00225784|Secondary|Number of Participants Determined to be Resectable (Eligible for Surgery)After Completion of Therapy|Tumor resectability is based on CT scan and as defined by the American Hepato-Pancreato-Biliary Association Convened Consensus Conference on Resectable and Borderline Resectable Pancreatic Cancer (Callery MP, et al. Ann Surg Oncol 2009; 16:1727-1733): no evidence of superior mesenteric vein (SMV) or portal vein (PV)abutment, distortion, tumor thrombus, or venous encasement, and clear fat planes around celiac axis (CA), hepatic artery (HA), and superior mesenteric artery (SMA).|1 month after completion of treatment|Surviving participants who completed therapy and were determined to be resectable.||participants|||Number
713936|NCT00225784|Secondary|Number of Participants Assessed for Adverse Events|Adverse events assessed using Common Terminology Criteria for Adverse Events version 3.0|Participants were followed during treatment and for 30 days after completion of treatment|All participants were evaluated for toxicity.||participants|||Number
713937|NCT00225784|Primary|Objective Response of Tumor by RECIST 1.0 Criteria|Per RECIST Criteria (v. 1.0) and assessed by CT scan: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in sum of the longest diameter (SLD)of target lesions at baseline; Progressive Disease (PD), >=20% increase in the SLD of target lesions at baseline; Stable Disease (SD), Neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD.|one month post-therapy|Completion of treatment||participants|||Number
713938|NCT00226239|Other Pre-specified|EGFR-related Serum Markers|Evaluation of changes in serum markers (EGFR-related) before and after therapy in the above patient population, and expression of pAKT, pMAPK, and other EGFR pathway-related markers as well angiogenesis biomarkers.|Up to 36 months||||||
713939|NCT00226239|Secondary|Quality of Life (QOL)|"Effect of treatment on acute and late QOL and functional status using Functional Assessment of Cancer Therapy–General (FACT-G) with FACT-Head and Neck (FACT-HN) subscale. The instructions to the participant were: Below is a list of statements that other people with your illness have said are important. By circling one number per line, please indicate how true each statement has been for you during the past 7 days. The choices for each statement ranged from 0 (not at all) to 4 (very much). The FACT-G and FACT-Head and Neck total scores were computed by summing 27 and 39 questions respectively, for four subscales: physical well-being, social well-being, emotional well-being, and functional well-being. Questions for both assessments are phrased so that higher numbers/values indicate a better health state."|Pre-treatment, Post-induction, 3 months after XPE and 12 months after XPE|Analysis was completed using all responses actually obtained.||units on a scale||Standard Deviation|Mean
713940|NCT00226239|Secondary|3-year Overall Survival (OS)|Three-year OS is an estimated percentage of participants still living at three years after the start of study treatment.|Up to 36 months|All participants that started were evaluable for this outcome measure, except for the one patient removed from study due to hypersensitivity reaction on cycle 1, day 1.||percentage of participants||95% Confidence Interval|Number
713941|NCT00226239|Secondary|2-year Overall Survival (OS)|Two-year OS is an estimated percentage of participants still living at two years after the start of study treatment.|Up to 24 months|All participants that started were evaluable for this outcome measure, except for the one patient removed from study due to hypersensitivity reaction on cycle 1, day 1.||percentage of participants||95% Confidence Interval|Number
713942|NCT00226239|Secondary|Progression-free Survival (PFS)|PFS is an estimated percentage of participants without disease progression at two years (or three years) after the start of study treatment. Progression was defined using Response Evaluation Criteria In Solid Tumors (RECIST), version 1.0. The two-year and three-year PFS ended up being the same in this study.|Up to 36 months|All participants that started were evaluable for this outcome measure, except for the one patient removed from study due to hypersensitivity reaction on cycle 1, day 1.||percentage of participants||95% Confidence Interval|Number
713943|NCT00226239|Secondary|Objective Response Rate (ORR)|Objective response rate is defined as the percentage of participants with a best response of complete response or partial response. Disease assessments were based on Response Evaluation Criteria in Solid Tumors (RECIST), version 1.0.|Up to 36 months|Docetaxel 75 mg/m^2 day 1, cisplatin 75 mg/m^2 day 1, and cetuximab 250 mg/m^2 days 1, 8, and 15 (after an initial loading dose of 400 mg/m^2), termed TPE, repeated every 21 days for three cycles, followed by radiotherapy with concurrent cisplatin 30 mg/m^2 and cetuximab weekly (XPE).||percentage of participants||95% Confidence Interval|Number
713944|NCT00226239|Primary|Objective Response Rate (ORR)|Objective response rate is defined as the percentage of participants with a best response of complete response or partial response. Disease assessments were based on Response Evaluation Criteria in Solid Tumors (RECIST), version 1.0.|Up to 36 months|Treated with docetaxel 75 mg/m^2 day 1, cisplatin 75 mg/m^2 day 1, and cetuximab 250 mg/m^2 days 1, 8, and 15 (after an initial loading dose of 400 mg/m^2), termed TPE, repeated every 21 days for three cycles.||percentage of participants||95% Confidence Interval|Number
713945|NCT00226577|Secondary|Toxicity|Number of participants with toxicity ≥ Grade 3 after gemcitabine plus pemetrexed induction chemotherapy.|06/20/2008 Index date for patients enrolled between 04/2004 and 04/2006|A total of 52 eligible patients, 26 men and 26 women, between the ages of 41 and 83 years received at least one dose of chemotherapy. Only 49 patients were evaluable because 3 patients had only the first cycle.||participants|||Number
713946|NCT00226577|Secondary|Survival - Overall|Median range of number of participants with Overall Survival. Overall survival (OS) will be defined as the period of time from the first day of drug treatment to the date of death of the patient. Patients taken off study will be followed quarterly until death for survival data.|06/20/2008 Index date for patients enrolled between 04/2004 and 04/2006|All patients||months||Full Range|Median
713947|NCT00226577|Secondary|Survival - Disease Free|Disease-free survival (DFS) is defined as the period of time from surgery to the time when disease recurrence is clearly documented. A histologic confirmation is required in equivalent cases.|06/20/2008 Index date for patients enrolled between 04/2004 and 04/2006|40 patients with complete tumor resection.||months||Full Range|Median
713948|NCT00226577|Secondary|Disease Response - Pathologic|Number of participants with Pathologic Complete Response. Pathologic complete response (pCR) is defined by a surgical pathology specimen, which consists of equal to or more than 95% fibrosis and necrosis.|06/20/2008 Index date for patients enrolled between 04/2004 and 04/2006|A pathologic response evaluation was possible in 43 of 52 patients.||participants|||Number
714142|NCT00224874|Secondary|Number of Patients Surviving at 6 and 9 Months Post Randomization||Measured at 6 and 9 months|All patients randomized were included in the analysis on an intent-to-treat basis||participants|||Number
713949|NCT00226577|Primary|Disease Response - Radiographic|"Number of participants with partial or Complete Response. Complete response (CR) is defined as the total disappearance of all malignant and evaluable clinical evidence of cancer without the development of any new malignant lesions documented on the post chemotherapy chest CT and PET scan.
Partial response (PR) (measurable disease only): When compared with pre-treatment measurements, a reduction of >30% in the sum of the largest diameters of all measurable lesions and absence of new lesions."|06/20/2008 Index date for patients enrolled between 04/2004 and 04/2006|A radiographic response evaluation was possible in 49 of 52 patients.||participants|||Number
713950|NCT00226590|Secondary|Treatment Completion|The number of participants who completed all treatment on schedule without dose reductions or delays.|Ranging from 2 weeks up to 4 years, 9 months|per protocol||participants|||Number
713951|NCT00226590|Secondary|Overall Survival|To determine median Overall Survival rate|Ranging from 2 weeks up to 4 years, 9 months|||months||95% Confidence Interval|Median
713952|NCT00226590|Secondary|Progression Free Survival|To determine median Progression Free Survival rate. Progression-free survival (PFS) is defined as the interval between the date of the first chemotherapy administration and the date of objective progression or death. Progression was evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee.|Ranging from 2 weeks up to 4 years, 9 months|per protocol||months||95% Confidence Interval|Median
713953|NCT00226590|Primary|Number of Participants Whose Response Allowed Them to Proceed to Chemoradiation|Response Rates - Complete Response (CR) + Partial Response (PR): We determined the number of participants whose response (both CT and PET assessment) to two cycles of induction chemotherapy with gemcitabine and carboplatin allowed them to proceed to chemoradiation. Response was evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee.|Ranging from 2 weeks up to 4 years, 9 months|Per Protocol||participants|||Number
713954|NCT00226655|Primary|Long Term Safety and Tolerability of hCRF|Number of patients reporting adverse events|Prospective|Intent to Treat||Participants|||Number
713955|NCT00226811|Primary|Objective Response (Complete Response (CR) or Partial Response (PR))|Number of patients with Objective Response (OR): confirmed CR or confirmed PR according to the Response Evaluation Criteria in Solid Tumors (RECIST). CR = the disappearance of all target lesions. PR = a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|From start of study treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter|ITT population||participants|||Number
713956|NCT00226811|Secondary|Overall Survival|Time from the date of first dose of study medication to the date of death due to any cause. OS was calculated as (date of death minus the date of first dose date plus 1) divided by 7.|From start of study treatment until death|ITT population||weeks||95% Confidence Interval|Median
713957|NCT00226811|Secondary|Time to Tumor Progression (TTP)|Time from the start of study treatment to the first documentation of objective tumor progression. TTP was calculated as (first event date minus the date of first dose plus 1) divided by 7.|From start of study treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter|ITT population||weeks||95% Confidence Interval|Median
713958|NCT00226811|Secondary|Progression-Free Survival|Time from start of study treatment to first documentation of objective tumor progression, or to death due to any cause. PFS was calculated as (first event date minus the date of first dose plus 1) divided by 7.|From start of study treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter or death|ITT population||weeks||95% Confidence Interval|Median
713959|NCT00226811|Secondary|Duration of Response (CR or PR)|Time from the first documentation of confirmed objective response (CR or PR) to the first documentation of disease progression or to death due to any cause. CR = the disappearance of all target lesions. PR = a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Day 28 of Cycle 1 and Day 28 of Cycles thereafter or death due to cancer|ITT population||weeks||Full Range|Mean
713960|NCT00226811|Secondary|Clinical Benefit Response (CBR)-Complete Response (CR), Partial Response (PR) or Stable Disease (SD) With Duration ≥ 24 Weeks|Number of patients with Clinical Benefit Response: confirmed CR, confirmed PR or stable disease (SD) for at least 24 weeks on study according to the Response Evaluation Criteria in Solid Tumors (RECIST). CR = the disappearance of all target lesions. PR = a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. SD = neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progessive disease (PD) taking as a reference the smallest sum of the longest dimensions since the treatment started.|From start of study treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter or clinical benefit response for at least 24 weeks on study|ITT population||participants|||Number
713961|NCT00226811|Primary|Best Overall Response|Number of patients with best overall response = complete response (CR) or confirmed partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses were those that persisted on repeat imaging study ≥4 weeks after initial documentation of response. CR = the disappearance of all target lesions. PR = a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|From start of study treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter|Intent-to-treat (ITT) population includes all patients enrolled in the study that received at least 1 dose of study medication.||participants|||Number
713962|NCT00227019|Secondary|Overall Survival (OS)|"Overall Survival (OS) is defined as the duration of time from start of treatment to deat.
Kaplan-Meier survival curves for OS were generated with IBM SPSS Statistics version 19.0 (SPSS, Inc, Chicago, IL)."|18 months|||months||95% Confidence Interval|Median
713963|NCT00227019|Secondary|Progression-free Survival (PFS)|"Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of documented disease progression or death.
Kaplan-Meier survival curves for PFS were generated with IBM SPSS Statistics version 19.0 (SPSS, Inc, Chicago, IL)."|18 months|||months||95% Confidence Interval|Median
713964|NCT00227019|Primary|Incidence of Central Nervous System (CNS) Hemorrhagic Events|Number of events of brain or central nervous system (CNS) bleeding|18 months|All participants in this study are included in the analysis population||CNS hemorrhagic events|||Number
714143|NCT00224874|Secondary|Number of Patients With Chronic Graft-versus-host Disease (GVHD)|Number of patients with limited and extensive chronic GVHD at 9 months|Measured at 9 months|All patients randomized were included in the analysis on an intent-to-treat basis||participants|||Number
713965|NCT00227266|Secondary|Max CMAP Area (Median)|The maximum Compound Motor Action Potential (CMAP) area is a measurement obtained through EMG testing that is associated with disease progression. In this study, we measure the maximum CMAP by stimulating one nerve in the hand and measuring the response of the muscle. This procedure is repeated multiple times. The maximum area is the response that results in the largest area under the response curve.|1 month prior to official enrollment, beginning of study (0 months), 6 months, 12 months (data point not available)|||mVms||Full Range|Median
713966|NCT00227266|Secondary|Max CMAP Area (Mean)|The maximum Compound Motor Action Potential (CMAP) area is a measurement obtained through EMG testing that is associated with disease progression. In this study, we measure the maximum CMAP by stimulating one nerve in the hand and measuring the response of the muscle. This procedure is repeated multiple times. The maximum area is the response that results in the largest area under the response curve.|1 month prior to official enrollment, beginning of study (0 months), 6 months, 12 months (data point not available)|||mVms||Standard Deviation|Mean
713967|NCT00227266|Secondary|DEXA||0, 6mo, 12mo||||||
713968|NCT00227266|Primary|Modified Hammersmith Change From Baseline to 6 Months|Comparison of Modified Hammersmith Change from baseline to 6 months. Scores range from 0 to 40. A higher score indicates a better outcome. This scale is used to assess gross motor abilities of non-ambulant children with SMA in multiple research trials as well as in clinical settings.|0 months, 6 months|Analysis only pertains to cohort 1a and 1b.||Score||Standard Deviation|Mean
713969|NCT00227266|Post-Hoc|Modified Hammersmith Extend Baseline|"Baseline Modified Hammersmith Extend testing. The baseline test is the score they receive during their screening visits. This scale ranges from 0 to 56. A higher score indicates a better outcome.
This scale is used to assess gross motor abilities of children with SMA in multiple research trials as well as in clinical settings."|1 month prior to enrollment, at enrollment (0 months)|Analysis was determined per protocol||Score||Full Range|Mean
713970|NCT00227266|Secondary|Nutritional Status||-4 wks, 0, 3mo, 6mo, 12mo||||||
713971|NCT00227266|Secondary|Growth and Vital Sign Parameters||-4 wks, 0, 3mo, 6mo, 12mo||||||
713972|NCT00227266|Secondary|Ulnar MUNE||-4 wks, 0, 3 mo, 6 mo, 12 mo||||||
713973|NCT00227266|Secondary|Max CMAP Amplitude Median|The maximum Compound Motor Action Potential (CMAP) is a measurement obtained through EMG testing that is associated with disease progression. In this study, we measure the maximum CMAP by stimulating one nerve in the hand and measuring the response of the muscle. This is done multiple times, the outcome used is the highest peak, or response observed.|1 month prior to official enrollment, beginning of study (0 months), 6 months, 12 months (data point not available)|||mV||Full Range|Median
713974|NCT00227266|Secondary|Max CMAP Amplitude (Mean)|The maximum Compound Motor Action Potential (CMAP) is a measurement obtained through EMG testing that is associated with disease progression. In this study, we measure the maximum CMAP by stimulating one nerve in the hand and measuring the response of the muscle. This is done multiple times, the outcome used is the highest peak, or response observed.|1 month prior to official enrollment, beginning of study (0 months), 6 months, 12 months (data point not available)|||mV||Standard Deviation|Mean
713975|NCT00227266|Secondary|Peds QL™ Assessment: Parental Version (All), Child Versions (> 5yrs)||-4wks, 0, 3mo, 6mo, 12mo||||||
713976|NCT00227266|Secondary|Quantitative Assessment of SMN mRNA From Blood Samples||-4wks or 0, 3 mo, 6 mo, 12 mo||||||
713977|NCT00227266|Primary|Efficacy, Measured Through Motor Function Assessments||-4wks, 0, 3 mo, 6 mo, 12 mo||||||
713978|NCT00227266|Primary|Safety Labs|Participants will have labs drawn regularly to maintain appropriate dosing and monitor liver function|-4 wks, 0, 2 wks, 3 mo, 6 mo, 9 mo, 12 mo for safety labs; throughout for AEs||||||
713979|NCT00227305|Primary|Change From OL Baseline in Supine Diastolic BP.|Changes from OL baseline to the final visits in Supine diastolic BP (mmHg)|OL baseline to Week 26|Number of participants with OL baseline and post treatment visits||mmHg||Standard Deviation|Mean
713980|NCT00227305|Primary|Change From OL Baseline in Supine Systolic BP.|Changes from OL baseline to the final visits in Supine systolic BP (mmHg)|OL baseline to Week 26|Number of participants with OL baseline and post treatment visits||mmHg||Standard Deviation|Mean
713981|NCT00227305|Primary|Change From Baseline in Supine Pulse|Change from OL baseline to week 26 in supine pulse (bpm)|OL baseline to week 26|Number of participants with OL baseline and post treatment visits||bpm||Standard Deviation|Mean
713982|NCT00227305|Primary|Change From Baseline in Weight|Number with 7% or more increase (without adjustment for normal growth)|26 weeks of treatment|Number of participants is based on patients with both baseline values and post-baseline values.||Participants|||Number
713983|NCT00227305|Primary|Categorical Change From Baseline in Barnes Akathisia Rating Scale (BARS) Global Score|"Number of patients for who the total score is estimated as worse. The Barnes Akathisia Rating Scale (BARS) global score is used to measure Akathisia (a type of movement disorders). BARS is the item 4 score from the BARS assessment. The scale is from a range 0-5 (normal to worse). Change from baseline in BARS global score increase means worse.
Improved defined as those with a <= -1 change in BARS global score. Worsened defined as those with a >= 1 change in BARS global score."|26 weeks of treatment|Number of patients with BARS score at OL baseline and week 26.||Participants|||Number
713984|NCT00227305|Primary|Categorical Change From OL Baseline to Week 26 in Simpson-Angus Scale (SAS)Total Score|"Number of patients for who the total score is estimated as worse. The Simpson Angus Scale (SAS)is used to assess Parkinsonian symptoms (a type of movement disorders). The score was calculated as the sum of the 10 individual item scores. Total Score ranges from 0-40 (normal to worse). Individual item scale range from 0 to 4 (normal to worse).
Improved define as those with a <= -1 change in SAS total score. Worsened defined as those with a >=1 change in SAS total score."|OL baseline to week 26|Number of patients with SAS score at OL baseline and week 26.||Participants|||Number
713985|NCT00227305|Secondary|Change From Baseline in Children's Global Assessment Scale (CGAS) Score|Children's Global Assessment Scale (CGAS) is used to rate the general functioning of children under the age of 18. It is the 100-point single-item score that was collected in the Clinical Report Form (CRF), scored from 0-100 (worse to normal).|OL Baseline to Week 26|Number of patients with CGAS score at OL baseline and week 26.||units on a scale||Standard Deviation|Mean
714045|NCT00228384|Secondary|Occurrence of Stent Fracture|The outcome of stent fracture measures the percentages of subjects that had stent fractures, as observed in their 2yr follow-up visit X-rays.|2 years|The number of participants analyzed is the number of subjects that returned for the 2yr follow-up and completed the X-ray assessment.||percentage of participants|||Number
713986|NCT00227305|Secondary|Changes in Tanner Stage|"Category shift in Tanner stage. Number of subjects who experienced the change is presented.
Tanner stages (I-V) was used to characterize physical development in children, adolescents, and adults. The stages was based on external primary and secondary sex characteristics, such as the size of the breasts, genitalia, and development of pubic hair. Tanner stage is considered going up when the organs grow bigger."|Change from OL baseline to week 26 in the Tanner stage|Number of patients with Tanner stagging data at OL baseline and week 26 (final visit)||Participants|||Number
713987|NCT00227305|Primary|Changes in Laboratory Test Results (Prolactin)|"Clinical important shift to high prolactin from open-label (OL) baseline to week 26.
High Prolactin is defined as value >26 ug/L for female and value >20 ug/L for male."|Duration of study participation|||Participants|||Number
713988|NCT00227305|Primary|Number of Patients Withdrawn Due to AEs.|Number of subjects who withdrew from the study due to AEs.|during 26 weeks of treatment|||Participants|||Number
713989|NCT00227305|Primary|Incidence and Nature of Adverse Events (AEs)|Number of participants that had AE which occurred from first dose date to last dose date + 30 days.|from open label to week 26+ 30 days|||Participants|||Number
713990|NCT00227344|Secondary|Percentage of Participants With Normal Sinus Rhythm at the Last Follow-up Visit Measured by ECG and 24-hour Holter Monitor||at each patients last follow-up visit|Intention to Treat (ITT)analysis of sinus rhythm was performed for subjects with available Holter Monitor data.||percentage of participants|||Number
713991|NCT00227344|Secondary|Health-economics Parameters (Days of Hospitalization)||at 26 months and at each patients last follow-up visit|Data not analyzed due to study termination - insufficient data to identify meaningful differences and draw significant conclusions.|||||
713992|NCT00227344|Secondary|Quality of Life||at 14, 26 and 38 months|"Study termination due to randomization imbalance. Data not analyzed since enrollment limited and therefore insufficient data to identify meaningful differences and draw significant conclusions. The 0 below represents not available."|||||
713993|NCT00227344|Secondary|Percentage of Participants Achieving Clinical Success (Subjects Taking AADs That Remain Free From Any Tachyarrhythmias) in Association With Antiarrhythmic Drugs||at 26 months and at each patients last follow-up visit|"Study termination due to randomization imbalance. Data not analyzed since enrollment limited and therefore insufficient data to identify meaningful differences and draw significant conclusions. The 0 below represents not available."|||||
713994|NCT00227344|Secondary|Time to First Recurrence of Any Tachyarrhythmias Lasting 30 or More Seconds After the Run in Phase||day 61 through 790|"Intention to treat (ITT) analysis includes subjects with available transtelephonic monitoring data. The upper bound of the confidence interval for the drug treatment group could not be calculated because of the high censoring rate. Therefore, NA is more appropriate in place of the maximum duration of follow-up (790.0) as the upper bound."||days||95% Confidence Interval|Median
713995|NCT00227344|Secondary|Percentage of Procedural Success|"Procedural success was determined on the day of the procedure (Day 0) and was based on responses to the following:
“Has a validation of the lesions been performed by taking 3 points inside each circular lesion?”
“If YES to #1, did you observe that none of them exceed 0.1 mV?”
“Did you observe any adverse event during the procedure?”
If the answers to (1 ) and (2 ) were YES and (3) was NO, then the procedure was determined a success."|The day of the procedure|"Procedural success was only calculated for the catheter ablation group. Intention to Treat (ITT) analysis of procedural success for the catheter ablation group was performed using available data. The 0 below the Antiarrhythmic Drug treatment group represents not available."||percentage of participants|||Number
713996|NCT00227344|Secondary|Percentage of Participants With Total Absence of Any Documented Atrial Tachyarrhythmias Lasting Longer Than 30 Seconds During the First 24 Months After the run-in Phase (2 Months)||within first 24 months after a 2-month run-in phase|Intention to treat (ITT) analysis includes subjects with available transtelephonic monitoring data.||percentage of participants|||Number
713997|NCT00227344|Primary|Percentage of Participants With Absence of Persistent Atrial Tachyarrhythmias Relapse During the First 24 Months After the run-in Phase (2 Months).|Persistent atrial tachyarrhythmia is defined as lasting 7 or more days per two consecutive transtelephonic monitoring or electrocardiogram recordings (obtained at least one week apart) with no cardioversions.|within first 24 months after a 2-month run-in phase|Intention to treat (ITT) analysis includes subjects with available transtelephonic monitoring data.||percentage of participants|||Number
713998|NCT00227370|Secondary|Ganciclovir Resistance|UL97 genotyping was done on all positive samples for CMV DNA at 1000 copies/mL, with resistance defined by the presence of 1 or more mutations shown by marker transfer to confer phenotypic ganciclovir resistance|over the course of 300 days post randomization|intention to treat||participants|||Number
713999|NCT00227370|Secondary|Severity of Viremia|upon diagnosis of cmv disease, the number of CMV DNA copies/mL as measured by PCR|over the course of 300 days after randomization|intention to treat||CMV copies/mL||Inter-Quartile Range|Median
714000|NCT00227370|Secondary|Non-CMV Infection|non cmv opportunistic infections|over the course of 300 days after randomization|intention to treat||participants|||Number
714001|NCT00227370|Secondary|Biopsy Proven Acute Lung Rejection||over the course of 300 days of randomization|intention to treat||participants|||Number
714002|NCT00227370|Secondary|Any CMV Infection|Inclusive of CMV syndrome, disease, or infection not meeting primary end point.|over the course of 300 days post randomization|intention to treat||participants|||Number
714003|NCT00227370|Primary|Incidence of CMV Syndrome|CMV clinical syndrome, with either positive serum PCR or positive culture for CMV from bronchoalveolar lavage and at least 2 of the following: fever, leukopenia, thrombocytopenia, elevated liver function test results malaise, reduction in pulmonary function (FEV1) greater than 20percent of baseline, or radiographic infiltrate consistent with CMV (all in the absence of other causes)|over the course of 300 days after randomization|intention to treat analysis||participants|||Number
714004|NCT00227370|Primary|Incidence of CMV End Organ Disease|The primary study end point was CMV end-organ disease determined by positive tissue immunostain or characteristic histopathology assessed for within 300 days post randomization.|over the course of 300 days after randomization|Intention to treat analysis was conducted.||participants|||Number
714046|NCT00228384|Secondary|Occurrence of Stent Fracture|The outcome of stent fracture measures the percentages of subjects that had stent fractures, as observed in their 1yr follow-up visit X-rays.|1 year|The number of participants analyzed is the number of subjects that returned for the 1yr follow-up and completed the X-ray assessment.||percentage of particpants|||Number
714005|NCT00227539|Secondary|Efficacy of Neoadjuvant Chemotherapy as Measured by Radiologic Response Rate|The number of patients that had either a CR, PR or SD after the completion of chemotherapy. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.|Up to 4 weeks after last dose of chemotherapy|One patient was excluded from the efficacy analysis because they were subsequently found to be ineligible. Three patients were unevaluable because they did not have have a CT scan after the completion of chemotherapy.||Participants|||Count of Participants
714006|NCT00227539|Secondary|Safety of Neoadjuvant Chemotherapy|The number of patients that experienced a grade 3 or higher adverse event.|Up to 4 weeks after last dose of chemotherapy|||Participants|||Count of Participants
714007|NCT00227539|Primary|Positron Emission Tomography as a Predictor of Response Measured by the Decrease in Standard Uptake Variable (SUV) After 1 Course of Therapy|Number of Participants with Decrease in Standard Uptake Variable (SUV) After 1 Course of Therapy|Between days 18 and 22 prior to second chemotherapy infusion|Only 19 patients had PET scans at both baseline and day 18-22 available for review.||Participants|||Count of Participants
714008|NCT00227591|Primary|Overall Response Rate|"Response was evaluated for Anemia and Spleen:
Major anemia response: hemoglobin increase to within normal limits in the absence of transfusion. Minor anemia response: hemoglobin improvement of at least 2 grams per deciliter independent of transfusion support, or achievement of transfusion independence in transfusion-dependent patients. Major spleen response: normalization of spleen size to the range of 12-14 centimeters by ultrasound. Minor spleen response: a 50% or more decrease in excess spleen size by ultrasound. Complete remission (CR): complete resolution of disease-related symptoms, splenomegaly, normalization of peripheral blood count, white cell differential and smear, and normalization of bone marrow histology. Partial remission (PR): a major or minor response in anemia or splenomegaly. Overall Response (OR)=CR + PR, assessed among eligible, treated patients."|Assessed at the end of cycle 3|6 ineligible patients were excluded from the analysis.||Proportion of participants||95% Confidence Interval|Number
714009|NCT00227721|Secondary|Progression-free Survival||Every two cycles||||||
714010|NCT00227721|Primary|Response Rate to the Combination of Gemcitabine and Docetaxel in Patients With Platinum Sensitive and Resistant Epithelial Ovarian or Peritoneal Cancer.||Disease status by Response Evaluation Criteria In Solid Tumors Criteria (RECIST) or Gynecological Cancer Intergroup (GCIG) CA-125 criteria was assessed every two cycles from enrollment up to progression, death, or five years (whichever occurred first).|||percentage of participants with CR or PR||90% Confidence Interval|Number
714011|NCT00227760|Secondary|Progression Free Survival||Time from start of treatment to progression, death or last contact, or last tumor assessment before the start of further antitumor therapy, assessed up to 6.5 years|Total patients||months||95% Confidence Interval|Median
714012|NCT00227760|Primary|Objective Response, Evaluated Using RECIST|Partial response as assessed by RECIST criteria|4 weeks|Evaluable patients||participants|||Number
714013|NCT00227760|Primary|Incidence of Durable Stable Disease, Evaluated Using the Response Evaluation Criteria in Solid Tumors (RECIST)|Stable disease for a clinical benefit rate, evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST)|4 weeks|Evaluable patients||particip[ants|||Number
714014|NCT00227903|Other Pre-specified|Attendance of Treatment Outside the Study|The number of patients who attended outside treatment in the 30 days prior to each assessment.|30 days prior to assessment|all randomized participants with data availabe at time frames||participants|||Number
714015|NCT00227903|Other Pre-specified|Adequacy of Received Services|Based on prenatal care attendance: the percent of visits attended after prenatal care initiation, accounting for time of delivery. Attendance was rated according to the Kotelchuck Adequacy of Prenatal Care Index. Only the normally scheduled prenatal car visits were included.|After prenatal care initiation|All randomized participants, 6 women had unkown attendance.||participants|||Number
714016|NCT00227903|Secondary|Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine|Based on urine tests for marijuana, cocaine or opioids|Delivery to 3 months post-delivery|All randomized participants with a baseline diagnosis of drug abuse or dependence, and with both self-report and urine data for the time frame.||proportion of participants|||Number
714017|NCT00227903|Secondary|Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine|Based on urine tests for marijuana, cocaine or opioids|intake to delivery, an average of 21 weeks|All randomized participants with a baseline diagnosis for drug abuse or dependence, and with both self-report and urine data.||proportion of participants|||Number
714018|NCT00227903|Secondary|Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine|Based on urine tests for marijuana, cocaine or opioids|Delivery to 3 months post-delivery|All randomized participants without a baseline diagnosis of drug abuse or dependence, and with both self-report and urine data for the time frame.||proportion of participants|||Number
714019|NCT00227903|Secondary|Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine|Based on urine tests for marijuana, cocaine or opioids.|intake to delivery, an average of 21 weeks|All randomized participants without a baseline diagnosis of drug abuse or dependence, and with both self-report and urine data.||proportion of participants|||Number
714020|NCT00227903|Secondary|Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine|Based on urine tests for marijuana, cocaine or opioids.|Delivery to 3 months post-delivery|All randomized participants with a baseline diagnosis of drug abuse or dependence and urine data.||proportion of participants|||Number
714021|NCT00227903|Secondary|Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine|Based on urine tests for marijuana, cocaine or opioids.|intake to delivery, an average of 21 weeks|All randomized participants with a baseline diagnosis of drug abuse or dependence and urine data.||proportion of participants|||Number
714022|NCT00227903|Secondary|Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine|Based on urine tests for marijuana, cocaine or opioids.|Delivery to 3 months post-delivery|All randomized participants without a baseline diagnosis of drug abuse or dependence and urine data during the time frame.||proportion of participants|||Number
714023|NCT00227903|Secondary|Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine|Based on urine tests for marijuana, cocaine or opioids.|intake to delivery, an average of 21 weeks|All randomized participants without a baseline diagnosis for drug abuse or dependence and with urine data.||proportion of participants|||Number
714024|NCT00227903|Secondary|Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report||Delivery to 3 months post-delivery|All randomized participants with a baseline diagnosis of drug abuse or dependence and data available for the time frame.||proportion of participants|||Number
714025|NCT00227903|Secondary|Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report||intake to delivery, an average of 21 weeks|All randomized participants with a baseline diagnosis of drug abuse or dependence.||proportion of participants|||Number
714026|NCT00227903|Secondary|Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report||Delivery to 3 months post-delivery|All randomized participants without a baseline diagnosis of drug abuse or dependence with data available for the time frame.||proportion of participants|||Number
714027|NCT00227903|Secondary|Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report||intake to delivery, an average of 21 weeks|All randomized participants without a baseline diagnosis of drug abuse or dependence.||proportion of participants|||Number
714028|NCT00227903|Secondary|Proportion of Participants Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine|Based on urine tests for marijuana, cocaine, or opioids.|Delivery to 3 months post-delivery|All randomized participants with both self-report and urine data available during the time frame.||proportion of participants|||Number
714029|NCT00227903|Primary|Percentage of Days That Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol||Delivery to 3 months post-delivery|All randomized participants with a baseline diagnosis of drug abuse or dependence and data available for the time frame.||percentage of days||Standard Deviation|Mean
714030|NCT00227903|Primary|Percentage of Days That Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol||intake to delivery, an average of 21 weeks|All randomized participants with a baseline diagnosis for drug abuse or dependence.||percentage of days||Standard Deviation|Mean
714031|NCT00227903|Primary|Percentage of Days That Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol||Delivery to 3 months post-delivery|All randomized participants without a baseline diagnosis for drug abuse or dependence with data available for time frame.||percentage of days||Standard Deviation|Mean
714032|NCT00227903|Primary|Percentage of Days That Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol||intake to delivery, an average of 21 weeks|All randomized participants without a baseline diagnosis of drug use or dependence.||percentage of days||Standard Deviation|Mean
714033|NCT00227903|Secondary|Proportion of Participants Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine|Based on urine tests for marijuana, cocaine or opioids.|intake to delivery, an average of 21 weeks|All randomized participants with both self-report and urine data available.||proportion of participants|||Number
714034|NCT00227903|Secondary|Proportion of Participants Abstinent From Drugs According to Urine|Based on urine tests for marijuana, cocaine, or opioids|Delivery to 3 months post-delivery|All randomized participants for whom urine data was available during the time frame.||proportion of participants|||Number
714035|NCT00227903|Secondary|Proportion of Participants Abstinent From Drugs (i.e., Marijuana, Cocaine or Opioids) According to Urine||intake to delivery, an average of 21 weeks|All randomized participants for whom urine test data was available.||proportion of participants|||Number
714036|NCT00227903|Secondary|Proportion of Participants Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report||Delivery to 3 months post-delivery|All randomized participants with data available from the time frame.||proportion of participants|||Number
714037|NCT00227903|Secondary|Proportion of Participants Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report||intake to delivery, an average of 21 weeks|All randomized participants||proportion of participants|||Number
714038|NCT00227903|Secondary|Incidence of Low Birth Weight||At delivery|Only singleton live births, which occurred in 163 subjects, were analyzed. Three of the women in the MI-CBT group had an infant of unknown birth weight, and were not included in analysis.||low weight births|||Number
714039|NCT00227903|Primary|Percentage of Days Used Drugs or Alcohol||delivery to 3 months post-delivery|all randomized participants with data from delivery and 3 months post-delivery||percentage of days||Standard Deviation|Mean
714040|NCT00227903|Secondary|Incidence of Preterm Births||At delivery|A singleton live birth occurred in 163 subjects, and 5 had twins. Data was collected from the 84 women of the Brief Advice category and the 79 women of the MI-CBT category who had singleton live births.||preterm births|||Number
714041|NCT00227903|Primary|Percentage of Days Used Drugs or Alcohol||intake to delivery, an average of 21 weeks|all randomized participants||percentage of days||Standard Deviation|Mean
714042|NCT00227994|Secondary|Medication Tolerability|Withdrawal due to side effects|Measured throughout the study|||participants|||Number
714043|NCT00227994|Primary|Physical Function (Measured by the FIM-motor)|Score on Functional Independence Measure (FIM) motor score, where 7 indicates total assistance/complete dependence and 91 is complete independence|Measured at weeks 0 and 12|||units on a scale||Standard Deviation|Mean
714044|NCT00228384|Secondary|Occurrence of Stent Fracture|The outcome of stent fracture measures the percentages of subjects that had stent fractures, as observed in their 3yr follow-up visit X-rays.|3 years|The number of participants analyzed is the number of subjects that returned for the 3yr follow-up and completed the X-ray assessment.||percentage of participants|||Number
714047|NCT00228384|Secondary|Alternate Peak Systolic Velocity Ratio (Less Than or Equal to 3.0)|The PSVR is the ratio of the highest velocity (or pressure) of the blood moving through the stent divided by the velocity immediately outside the stent (the end of the stent nearest to the heart). Pressures are measured by ultrasound. These results include the percentage of subjects that had a PSVR of equal or less than 3.0.|3 years|||percentage of subjects||95% Confidence Interval|Number
714048|NCT00228384|Secondary|Alternate Peak Systolic Velocity Ratio (PSVR) (Equal or Less Than 2.5)|The PSVR is the ratio of the highest velocity (or pressure) of the blood moving through the stent divided by the velocity immediately outside the stent (the end of the stent nearest to the heart). Pressures are measured by ultrasound. These results include the percentage of subjects that had a PSVR of equal or less than 2.5.|3 years|||percentage of subjects||95% Confidence Interval|Number
714049|NCT00228384|Secondary|Change in Ankle-Brachial Index (ABI)|"This test is done by measuring blood pressure at the ankle and the arm while a person is at rest. The ABI is then calculated by dividing the systolic blood pressure at the ankle by the systolic blood pressures in the arm.
A normal resting ABI is 0.9 to 1.3. A resting ABI of less than 0.9 is abnormal.
An outcome of a higher mean ABI is considered a success."|3 years|The number of participants analyzed is the number of subjects that returned for the 3yr follow-up and had the ABI completed and recorded.||ABI Value||Standard Deviation|Mean
714050|NCT00228384|Secondary|Quality of Life Subject Self-assessments (Short Form:36 (SF:36) - Physical Summary Score)) (Clinical Success)|"The SF-36 Health Survey (version 2) asks 36 questions to measure health and well-being from the patient's point of view. The subscale and total score ranges from 0 to 100 but is normalized so that a score of 50 is the population mean, with a standard deviation of 10.
The SF:36 - Physical Summary Score Questionnaire score must improve in order to be considered for clinical success. An increase in the mean score from baseline indicates an improvement in the patient's condition and a decrease indicates a decline."|3 years|The number of participants analyzed is the number of subjects that returned for the 3yr follow-up and completed the assessment.||Score||Standard Deviation|Mean
714051|NCT00228384|Secondary|Quality of Life Subject Self-assessments (Short Form:36 (SF:36) - Mental Summary Score)) (Clinical Success)|"The SF-36 Health Survey (version 2) asks 36 questions to measure health and well-being from the patient's point of view. The subscale and total score ranges from 0 to 100 but is normalized so that a score of 50 is the population mean, with a standard deviation of 10.
The SF:36 - Mental Summary Score Questionnaire score must improve in order to be considered for clinical success. An increase in the mean score from baseline indicates an improvement in the patient's condition and a decrease indicates a decline."|3 years|The number of participants analyzed is the number of subjects that returned for the 3yr follow-up and completed the assessment.||Score||Standard Deviation|Mean
714052|NCT00228384|Secondary|Quality of Life Subject Self-assessments (Intermittent Claudication Questionnaire: ICQ) (Clinical Success)|"The ICQ is a series of 16 questions asking about leg pain and limitations to activities such as walking specific distances, doing daily activities, worrying about pain, resting during activities, and similar. Most questions specifically ask about only the two weeks prior to answering the completion of the questionnaire.
Improvement in Intermittent Claudication Questionnaire (ICQ) is a lower score (0 = best, 100 = worst). A decrease in mean score from baseline indicates an improvement in the patient's condition and an increase indicates a decline."|3 years|Number of subjects that returned for 3yr follow-up appointment and completed the ICQ.||Score||Standard Deviation|Mean
714053|NCT00228384|Secondary|Improvement in Rutherford Classification (Clinical Success)|"The Rutherford Classification is a system used to score Peripheral Artery Disease (PAD). The stages follow (higher numbers are worse):
Stage 0 – Asymptomatic Stage 1 – Mild claudication Stage 2 – Moderate claudication Stage 3 – Severe claudication Stage 4 – Rest pain Stage 5 – Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 – Severe ischemic ulcers or frank gangrene
The percentage of people improving by at least one stage (moving frm higher number to lower number) is listed in the results."|3 years|The number of participants analyzed was the number of subjects that returned for the 3yr follow-up visit and for which we had data.||percentage of participants|||Number
714054|NCT00228384|Secondary|Target Lesion Revascularization (TLR)|This measure shows the percentage of subjects that had at least one repeat intervention in the target lesion during their enrollment in the clinical study.|3 years|||percentage of participants|||Number
714055|NCT00228384|Secondary|Target Vessel Revascularization (TVR)|This measure shows the percentage of subjects that had at least one repeat intervention performed during their enrollment in the clinical study.|3 years|||percentage of participants|||Number
714056|NCT00228384|Secondary|Technical Success at Initial Procedure|"Technical success is defined as a composite of both a) restoration of superficial femoral artery (SFA) patency with < 30% residual stenosis (narrowing) within the treated arterial segment as viewed on post-procedure completion angiography, and b) Final Hemodynamic Pressure Gradient ≤15mm Hg (mercury). A lower pressure gradient number indicates less resistance to blood flow; i.e., less stenosis or narrowing of the vessel under the pressure of the flow.
The results show the percentage of study subjects that had technical success."|Time of implant procedure|The number of participant analyzed were those for which we had data. Not all sites recorded both measures required to calculate technical success.||percentage of subjects|||Number
714057|NCT00228384|Secondary|Secondary Patency|Secondary patency is defined as maintaining patency in the target vessel after a repeat intervention to correct complete occlusion in the treated arterial segment.|3 years|||percentage of subjects||95% Confidence Interval|Number
714058|NCT00228384|Secondary|Primary Assisted Patency|Primary assisted patency is defined as when the subject had a repeat intervention to regain patency in order to salvage the stent prior to complete occlusion.|3 years|||percentage of subjects||95% Confidence Interval|Number
714059|NCT00228384|Primary|Safety: Composite of Major Procedural (30-day) Adverse Events (AEs)|Major procedural events include death, myocardial infarction, acute renal insufficiency, study limb amputation, and access site and treatment site complications requiring surgery or blood transfusion. The results for this outcome measure are the total percent of these events that occurred in each treatment arm within the first 30 days following stent implantations.|30 days|||percentage of subjects|||Number
714104|NCT00229957|Secondary|Self-management and Self-efficacy|Individual's self-reported ability to carry out behaviours to self-manage their health condition, and their confidence level in being able to carry out these behaviours. (Score range 0= not confident at all, 10= totally confident).|baseline, 15 months||08/2009||||
714060|NCT00228384|Primary|Efficacy: Primary Patency at Three Years|"Primary patency is the Peak Systolic Velocity Ratio (PSVR) maintained at or below 2.0 without any repeat intervention.
The PSVR is the ratio of the highest velocity (or pressure) of the blood moving through the stent divided by the velocity immediately outside the stent (the end of the stent nearest to the heart). Pressures are measured by ultrasound. These results include the percentage of subjects that maintained primary patency at or below 2.0 without any repeat intervention through the end of the study (three years)."|3 years|||percentage of subjects||95% Confidence Interval|Number
714061|NCT00228553|Primary|Safety and Tolerability in This Patient Population (Narcolepsy, OSAHS, SWSD) Over Time (up to 2 Years)|An adverse event is any untoward medical occurrence in a patient that develops or worsens in severity during the conduct of a clinical study. Serious and Non-serious Adverse Events (SAEs). Serious adverse event is any adverse event occurring at any dose that results in any of the following outcomes: death, life-threatening, inpatient hospitalization, persistent or significant disability, congenital anomaly, or an important medical event. An adverse event that does not meet any of the criteria for seriousness listed previously will be regarded as a nonserious adverse event.|End of months 1, 3, 6, 9, and 12 and every 3 months for up to an additional year|Safety Analysis set of 731 total patients: 12 participants (3 female ; 9 male) withdrew after randomization but prior to receiving study drug.||Participants|||Number
714062|NCT00228566|Primary|Number of Responders to the Patient Global Impression of Change (PGI-C) Ratings|A subjective measure (PGI-C rating) of the patient’s global health, ie, a patient’s rating of disease severity, as compared with a pretreatment (baseline) evaluation assessment by the patient using the Patient Global Impression of Severity of illness (PGI-S). Responders at each visit were defined as having at least minimal improvement in the severity of excessive sleepiness as compared with a pretreatment evaluation made using the PGI-S.|Weeks 4, 8, and 12, at 3 month intervals thereafter, and at a Final Visit (or last postbaseline observation). Evaluation continues until the Final Visit, which occurs when the product is commercially available or the marketing application is withdrawn.|||Participants|||Number
714063|NCT00228813|Primary|Incidence of Chronic Graft-versus-host Disease|The number of participants diagnosed with chronic graft-versus-host disease (GVHD).|Duration of Study (Up to two years)|Participants who survived beyond Day 100 post bone marrow transplant.||participants|||Number
714064|NCT00228813|Primary|Incidence of Acute Graft-versus-host Disease|The number of participants diagnosed with new acute graft-versus-host disease (GVHD).|Day 100|Participants who who developed acute GVHD was measured at Day 100 post bone marrow transplant.||participants|||Number
714065|NCT00228813|Primary|Engraftment Rate|The number of participants who received in vivo T-cell-depleted G-CSF stimulated bone marrow from partially mismatched related donor who reached engraftment by Day 45.|Day 45|||particpants|||Number
714066|NCT00228917|Secondary|Number of Subjects With Serious Adverse Events (SAEs).|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From 15 to 18 months or 15 to 24 months of age and up to 25 to 31 months of age post vaccination|This analysis was performed on the Pooled Booster Total Vaccinated cohort included all subjects from the groups that were in common to the two studies (NCT00228917 & NCT00136604).||Subjects|||Number
714067|NCT00228917|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs).|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Day 0-30) following booster vaccination|This analysis was performed on the Pooled Booster Total Vaccinated cohort included all subjects from the groups that were in common to the two studies (NCT00228917 & NCT00136604).||Subjects|||Number
714068|NCT00228917|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms.|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.|During the 4-day (Day 0-3) follow-up period after booster vaccination|This analysis was performed on the Pooled Booster Total Vaccinated cohort included all subjects from the groups that were in common to the two studies (NCT00228917 & NCT00136604), only taking into account those subjects who returned their symptom sheets.||Subjects|||Number
714069|NCT00228917|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Related = symptom assessed by the investigator as related to the vaccination.|During the 4-day (Day 0-3) follow-up period after vaccination|This analysis was performed on the Pooled Booster Total Vaccinated cohort included all subjects from the groups that were in common to the two studies (NCT00228917 & NCT00136604), only taking into account those subjects who returned their symptom sheets.||Subjects|||Number
714070|NCT00228917|Primary|Number of Subjects With Fever >39°C (Rectal Route).|Among solicited general symptoms fever [defined as rectal temperature equal to or above (≥) 38 degrees Celsius (°C )] was assessed, post vaccination. Grade 3 fever = fever > 39.0 °C.|During the 4-day (Day 0-3) follow-up period after booster vaccination|This analysis was performed on the Pooled Booster Total Vaccinated cohort included all subjects from the groups that were in common to the two studies (NCT00228917 & NCT00136604), only taking into account those subjects who returned their symptom sheets.||Subjects|||Number
714071|NCT00228943|Primary|Objective Subject Hot Flash Frequency|Mean of the 24 hour monitoring sessions for each patient based on one 24 hour monitoring session after each intervention using an electronic monitor.|One 24 hour monitoring session per week for 8 weeks|Subjects with completed hot flash data during both arms of study.||frequency of hot flashes||Standard Deviation|Mean
714072|NCT00228943|Primary|Serum Tryptophan Levels|Mean serum tryptophan levels (blood draw) at the end of the nadir period.|baseline, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours|The number of subjects with complete serum data for both arms of the study were analyzed.||nmol/ml||Standard Deviation|Mean
714073|NCT00229203|Secondary|Number of Patients With Overall Survival (OS)|Overall Survival (OS): time from the date of first infusion to the date of documented death|Start of treatment to death. At each patient visit while on treatment, then every 3m during follow-up. Median OS and OS rates at 6 months and 12 months were assessed.|Per protocol - Only 21 of 32 and 8 of 19 enrolled patients were evaluable (analyzed patients. For patient of group plitidepsin + dexamethasone the median overall survival could not be calculated due to follow-up short duration. The survival rates at 6 and 12 months are provided instead.||percentage patients|||Number
714074|NCT00229203|Secondary|Progression Free Survival (PFS)|Progression Free Survival (PFS): time from the date of first infusion to the date of documented progression or death|Every 2 weeks until progression or death occurs. Median PFS and PFS rates at 3 months and 6 months were assessed.|Per protocol - Only 21 of 32 and 8 of 19 enrolled patients were evaluable (analyzed patients)||months||Full Range|Median
714075|NCT00229203|Secondary|Time to Progression (TTP)|Time to Progression (TTP):date of first infusion to the date of documented progressive disease which can be defined as >25 percentage increase in level of serum monoclonal paraprotein.|Every 2 weeks until progression or death due to progression occurs. Median TTP and TTP rates at 3 months and 6 months were assessed.|Per protocol - Only 29 of 32 and 18 of 19 enrolled patients were evaluable (analyzed patients)||months||Full Range|Median
714076|NCT00229203|Primary|Objective Response Rate (ORR), Defined as the Combined Rate of Complete Response, Partial Response and Minimal Response|"Complete response(CR):0 percentage the original monoclonal protein level from blood and urine Partial response(PR): ≥50 percentage reduction in the level of serum monoclonal protein Minimal response(MR):≥25 percentage to ≤ 49 percentage reduction in the level of serum monoclonal protein Stable disease: Not meeting the criteria for MR or PD. Progressive disease: >25 percentage increase in level of serum monoclonal paraprotein, which must also be an absolute increase of at least 5 g/L and confirmed on a repeat investigation.
Treatmen failure: Reappearance of serum or urinary paraprotein"|Every 2 weeks until progression or death occurs.|Per protocol - Only 29 of 32 and 18 of 19 enrolled patients were evaluable (analyzed patients)||percentage patients|||Number
714077|NCT00229619|Secondary|Relapse, Disease Progression, Survival, Change in Transfusion Requirements, Response to Second Cycle of Rituximab and Compare the Efficacy and Safety Profile With a Similar Patient Population Who Are Participating on the Daclizumab Trial||6 months||||||
714078|NCT00229619|Secondary|Response Rates at 3 Months (After the First Dose of Study Med)||3 months||||||
714079|NCT00229619|Secondary|Secondary Endpoints Include Response at 3 Months, Durability of Response, Disease Progression, Survival and the Response to a Second Course of Therapy When Indicated.||3 months||||||
714080|NCT00229619|Primary|Response to Rituximab|"Rituximab will be given to moderate aplastic anemia (MAA), pure red cell aplasia or Diamond Blackfan anemia subjects. Rituxmiab will be given to evaluate if these bone marrow failure syndrome subjects will have an immune response to the intervention. The subjects will receive 375 mg/ meters squared of rituximab which will be infused intravenously once evey week for a total of 4 doses.
Primary endpoint will determine immune response by evaluating changes in peripheral blood counts (platelets, absolute neutrophil count, reticulocyte count, hemoglobin) and transfusion requirements at 6 months. The response wil be will be categorized as complete, partial or no response. Subjects will be categorized as complete responders if their blood counts return to normal. Subjects will categorized as partial responders if there is an improvement in 2 or 3 of the depressed baseline blood counts."|6 months|||participants|||Number
714081|NCT00229658|Secondary|Change in Body Weight From Baseline at Month 6|Mean change in body weight from baseline at month 6|6 months|Intent-to-Treat, patients who discontinue SYMLIN 7 or more days prior to a site visit are not included in the analyses||kg||Standard Error|Mean
714082|NCT00229658|Secondary|Change in Body Weight From Baseline at Month 3|Mean change in body weight from baseline at month 3|3 months|Intent-to-Treat, patients who discontinue SYMLIN 7 or more days prior to a site visit are not included in the analyses||kg||Standard Error|Mean
714083|NCT00229658|Secondary|Change in HbA1c From Baseline at Month 6|Change in HbA1c from baseline at month 6. The HbA1c test measures the percent of glycosylated hemoglobin in the blood.|6 months|Intent-to-Treat, patients who discontinue SYMLIN 7 or more days prior to a site visit are not included in the analyses||percent||Standard Error|Mean
714084|NCT00229658|Secondary|Change in HbA1c From Baseline at Month 3|Change in HbA1c from baseline at month 3. The HbA1c test measures the percent of glycosylated hemoglobin in the blood.|3 months|Intent-to-Treat, patients who discontinue SYMLIN 7 or more days prior to a site visit are not included in the analyses||percent||Standard Error|Mean
714085|NCT00229658|Secondary|Annual Event Rate of Medically Assisted Severe Hypoglycemia (MASH) During the Steady State Period|"The annual event rate was calculated as the total number of events during the time period divided by the total years of exposure to pramlintide for all patients during the time period. The steady state period represents the >3-6 months of pramlintide treatment following the adjustment period.
MASH is defined as episodes of severe hypoglycemia requiring IM glucagon, IV glucose, hospitalization, paramedic assistance, emergency room visit, and/or is assessed as a serious adverse event (SAE) by the investigator. MASH is a subset of PASH."|>3-6 months|Intent-to-Treat, number analyzed includes patients still enrolled in the study during the steady-state period (3-6 months)||Events per patient year|||Number
714086|NCT00229658|Secondary|Incidence of Medically Assisted Severe Hypoglycemia (MASH) During the Steady State Period|"The steady state period represents the >3-6 months of pramlintide treatment following the adjustment period.
MASH is defined as episodes of severe hypoglycemia requiring IM glucagon, IV glucose, hospitalization, paramedic assistance, emergency room visit, and/or is assessed as a serious adverse event (SAE) by the investigator. MASH is a subset of PASH."|>3-6 months|Intent-to-Treat, number analyzed includes patients still enrolled in the study during the steady-state period (3-6 months)||Incidence (%)|||Number
714087|NCT00229658|Secondary|The Annual Event Rate of Medically Assisted Severe Hypoglycemia (MASH) During the Adjustment Period|"The annual event rate was calculated as the total number of events during the time period divided by the total years of exposure to pramlintide for all patients during the time period. The adjustment period represents the initial 0-3 months of pramlintide treatment.
MASH is defined as episodes of severe hypoglycemia requiring IM glucagon, IV glucose, hospitalization, paramedic assistance, emergency room visit, and/or is assessed as a serious adverse event (SAE) by the investigator. MASH is a subset of PASH."|0-3 months|Intent-to-Treat||Events per patient year|||Number
714088|NCT00229658|Secondary|Incidence of Medically Assisted Severe Hypoglycemia (MASH) During the Adjustment Period|MASH is defined as episodes of severe hypoglycemia requiring IM glucagon, IV glucose, hospitalization, paramedic assistance, emergency room visit, and/or is assessed as a serious adverse event (SAE) by the investigator. MASH is a subset of PASH. The adjustment period represents the initial 0-3 months of pramlintide treatment|0-3 months|Intent-to-Treat.||Incidence (%)|||Number
714089|NCT00229658|Secondary|The Annual Event Rate of Patient-Ascertained Severe Hypoglycemia (PASH) During the Steady State Period|"The annual event rate was calculated as the total number of events during the time period divided by the total years of exposure to pramlintide for all patients during the time period. The steady state period represents the >3-6 months of pramlintide treatment following the adjustment period.
PASH is defined as episodes of hypoglycemia requiring the assistance of another individual (including aid in ingestion of oral carbohydrate); and/or requiring the administration of glucagon injection, intravenous glucose, or other medical intervention."|>3-6 months|Intent-to-Treat, number analyzed includes patients still enrolled in the study during the steady-state period (3-6 months)||Events per patient year|||Number
714090|NCT00229658|Secondary|The Incidence of Patient-Ascertained Severe Hypoglycemia (PASH) During the Steady State Period|"The steady state period represents the >3-6 months of pramlintide treatment following the adjustment period.
PASH is defined as episodes of hypoglycemia requiring the assistance of another individual (including aid in ingestion of oral carbohydrate); and/or requiring the administration of glucagon injection, intravenous glucose, or other medical intervention."|>3-6 months|Intent-to-Treat, number analyzed includes patients still enrolled in the study during the steady-state period (3-6 months)||Incidence (%)|||Number
714091|NCT00229658|Primary|Annual Event Rate of Patient-Ascertained Severe Hypoglycemia (PASH) During the Adjustment Period|"The annual event rate was calculated as the total number of events during the time period divided by the total years of exposure to pramlintide for all patients during the time period. The adjustment period represents the initial 0-3 months of pramlintide treatment.
PASH is defined as episodes of hypoglycemia requiring the assistance of another individual (including aid in ingestion of oral carbohydrate); and/or requiring the administration of glucagon injection, intravenous glucose, or other medical intervention."|0-3 months|Intent-to-Treat||Events per patient year|||Number
714092|NCT00229658|Primary|Incidence of Patient-Ascertained Severe Hypoglycemia (PASH) During the Adjustment Period|PASH is defined as episodes of hypoglycemia requiring the assistance of another individual (including aid in ingestion of oral carbohydrate); and/or requiring the administration of glucagon injection, intravenous glucose, or other medical intervention. The adjustment period represents the initial 0-3 months of pramlintide treatment|0-3 months|Intent-to-Treat||Incidence (%)|||Number
714093|NCT00229723|Secondary|Safety and Tolerability||Assessed over two years||||||
714094|NCT00229723|Secondary|Overall Survival|Percentage of participants who are alive at 2 years (calculated using the Kaplan-Meier method, which allows for patients who do not have complete follow-up (censored observations)).|Overall survival assessed at 2 years|||Percentage of participants|||Number
714095|NCT00229723|Secondary|Progression Free Survival|Percentage of participants who are progression free at 2 years (calculated using the Kaplan-Meier method, which allows for censored observations for example those lost to follow-up). A patient is said to have progressed if they have progression of target or non-target lesions or evidence of any new lesions (as defined by RECIST).|Clinical tumour assessments and tumour assessment by CT/MRI were carried out during screening and regularly throughout the study until disease progression (as defined by RECIST)|||Percentage of participants|||Number
714096|NCT00229723|Secondary|Tumour Response (Complete Response + Partial Response)|A patient was deemed to be have a tumour response if the RECIST criteria for complete response or partial response were satisfied at any time during the study.|Assessed at 2 years. Clinical tumour assessments and tumour assessment by CT/MRI were carried out during screening and regularly throughout the study until disease progression|||Participants|||Number
714097|NCT00229723|Secondary|Complete Response|A patient was deemed to be a complete responder if the RECIST criteria for complete response were satisfied at any time during the study.|Assessed at 2 years. Clinical tumour assessments and tumour assessment by CT/MRI were carried out during screening and regularly throughout the study until disease progression.|||Participants|||Number
714098|NCT00229723|Secondary|Local Disease Control Rate at 1 Year|A patient demonstrated local disease control at 1 year if there was no evidence of failure of treatment. Failure was defined as the patient having objective disease progression (as per RECIST) inside the original irradiated area, at an isodose level (between 20% and 95%), or death.|Assessed after 1 year. Tumour assessments (clinical and by CT/MRI) were carried out during screening & regularly throughout the study until disease progression (as defined by RECIST).|||Participants|||Number
714099|NCT00229723|Primary|Local Disease Control Rate at 2 Years|A patient demonstrated local disease control at 2 years if there was no evidence of failure of treatment. Failure was defined as the patient having objective disease progression (as per RECIST) inside the original irradiated area, at an isodose level (between 20% and 95%), or death.|Assessed at 2 yrs. Tumour assessments (clinical & by CT/MRI) were carried out during screening & regularly throughout the study until disease progression (as defined by Response evaluation criteria in solid tumours (RECIST)).|||Participants|||Number
714100|NCT00229931|Secondary|Rate of Elevated Intraocular Pressures, Retinal Detachment, Infection, and Vitreous Hemorrhage.||3 years|Data were not collected|||||
714101|NCT00229931|Primary|Main Outcome Measures Will be Quantitative Changes in OCT Central Thickness, Visual Acuity, and Number of Snellen Acuity Lines Gained/Lost.||3 years|Due to lack of follow up from patients, this outcome was not analyzed; data were not collected|||||
714102|NCT00229957|Secondary|Patient Satisfaction Questionnaire - 18 (Modified)|Patient satisfaction with the care they received. (Score range 0-5)|15 months||||||
714103|NCT00229957|Secondary|Physical Abilities (Strength, Balance)|Grip strength was measured using a JAMAR hand grip dynamometer (in kilograms). The Lower Extremity Function test is a battery of three tests used to measure lower extremity function and balance: a balance test, 8 foot walk test, and repetitive standing from a chair. A performance summary score is created by adding the number of seconds achieved on the balance test, the number of seconds to walk 8 feet and the number of seconds it takes the person to stand up from a chair five times consecutively (no maximum score exists on this measure).|baseline, 15 months||08/2009||||
714111|NCT00229970|Primary|The Time-weighted Average of Change in Forced Expiratory Volume in One Second (FEV1)|The Time Weighed Average Changes in Forced Expiratory Volume in One Second (FEV1) from pre-allocation baseline over the first 60 minutes after study drug administration with time interval between any measurement and the measurement prior to it is used as the weighting factor|baseline over the first 60 minutes|Last observed value during the 60 minutes treatment period was used in the Full Analysis Set (FAS)||Liter||95% Confidence Interval|Least Squares Mean
714112|NCT00230009|Primary|Treatment Engagement|The number of participants who reported seeking outpatient substance abuse treatment since baseline (either at a treatment facility or through outpatient counseling).|at 3 month follow-up|||participants|||Number
714113|NCT00230009|Secondary|Depression|Depression was measured by using the Center for Epidemiologic Studies Depression Scale (CES-D) at the 3 month follow-up. CES-D total scores can range from 0 to 60. Scores at 16 or higher indicate clinical significance. Higher scores represent higher risk for depression.|at 3 month follow-up|||units on a scale||Standard Deviation|Mean
714114|NCT00230009|Primary|Child Abuse Potential|Change score was calculated by taking the follow-up scores on the Brief Child Abuse Potential Inventory (BCAP) and subtracting the baseline score. The possible total score for the BCAP ranges from 0 to 24. Therefore, the possible range of scores for the change calculation (reported below) is -24 to +24. Higher scores indicate higher risk at the follow-up visit (worse outcome).|baseline and 3 month follow-up|||units on a scale||Standard Deviation|Mean
714115|NCT00230009|Primary|Drug Use|Drug use was measured by looking at frequency of use in past 30 days with the Alcohol Use Disorders Identification Test (AUDIT), reported about marijuana use at the 3 month follow-up. The mean of each the assessment only and intervention group was used. Scores ranged from 0 to 13 for the follow-up sample. Higher scores mean more frequent use of the substance.|3 month follow-up|A total of 43 participants returned for follow-up and were the only participants analyzed on this outcome.||units on a scale||Standard Deviation|Mean
714116|NCT00230009|Primary|Alcohol Use|Alcohol use was measured by looking at frequency of use in past 30 days with the Alcohol Use Disorders Identification Test (AUDIT), reported at the 3 month follow-up. The mean of each the control and intervention group was used. Frequency of use ranged from 0 to 5 for the follow-up sample. Higher scores mean more frequent use of the substance.|3 month follow-up|A total of 43 participants returned for follow-up and were the only participants analyzed on this outcome.||units on a scale||Standard Deviation|Mean
714117|NCT00230022|Primary|Motivation to Change Substance Use|An eight-item measure tapping motivation to change, self-efficacy, and change intention was assessed using visual analog scales. The average of the eight items was calculated resulting in a score ranging from 1 to 100. The measure was asked at baseline (reported in baseline data) and the one month follow-up. Scores here represent average level of motivation for change at the time of follow-up. Higher scores represent higher levels of motivation to change, self-efficacy and intention to change.|One month|A total of 30 participants were included in this pilot trial, based primarily on convenience and timeframe. The primary goal was effect-size estimation, so power was not a primary concern. Last Observation Carried Forward(LOCF) was utilized for 8 participants lost to follow-up.||units on a scale||Standard Deviation|Mean
714118|NCT00230048|Primary|Treatment Engagement|Completing at least a single intake or treatment session of any kind, focused on substance use within the previous 3 months.|3 months|ITT, treating all participants lost to follow up as failures (i.e., not receiving any treatment services)||participants|||Number
714119|NCT00230048|Primary|Number of Participants With Drug Use at 3 Months|The number of participants postive for drug use using participant's self-report of drug use and urinalysis. Participants were considered positive if self-report and/or urinalysis were positive.|3 months|Intent to treat, treating participants lost to follow-up as positive.||participants|||Number
714120|NCT00230100|Other Pre-specified|Baseline Addiction Severity Index Alcohol Composite Score for Women|The data reflect baseline characteristics of the participants with respect to ASI alcohol composite score. Scores range between 0 and 1. Higher scores reflect higher addiction severity. The ASI is a multidimensional assessment of substance-related problems which yields composite scores for alcohol use, drug use, psychiatric status, medical status, legal status, family/social relationships, and employment status.|Baseline|Only women were included in this analysis.||units on a scale||Standard Error|Mean
714121|NCT00230100|Other Pre-specified|Baseline Drinks Per Drinking Day for Women|The data reflect baseline characteristics of the women participants with respect to the number of drinks per drinking day in the 60 days prior to baseline intake. This was measured using the Timeline Follow-Back.|Baseline|Only women were included in this analysis.||Drinks per drinking day||Standard Error|Mean
714122|NCT00230100|Other Pre-specified|Baseline Substance Use Data for Women|The data reflect baseline characteristics of women participants with respect to (1) days of any substance use (i.e. drugs or alcohol), and (2) the number of drinking days, in the 60 days prior to baseline intake.This data was collected using the Timeline Follow-Back.|Baseline|Only women were included in this analysis.||Days||Standard Error|Mean
714123|NCT00230100|Post-Hoc|Client Satisfaction for Women|"Participant satisfaction with the groups was assessed using the Client Satisfaction Questionnaire (CSQ-8) plus four additional questions about the helpfulness of the therapist, group content, and group composition. Questions were answered on a 4-point scale where 1 reflected negative feelings and 4 reflected positive feelings. Participants' scores are calculated by adding up the numbers assigned to their chosen answers. Therefore, scores can range between 12 and 48, with higher scores reflecting greater satisfaction.
The CSQ was administered at week 3, 6, 9, and 12 while participants were in treatment. Scores represent calculated averages of the group averages for week 3, week 6, week 9, and week 12."|In treatment phase (week 1-12)|Only women were included in this analysis.||units on a scale||Full Range|Mean
714144|NCT00224874|Secondary|Number of Patients Discontinuing Immune Suppression Without Flare|Immunosuppression discontinuation was defined as the discontinuation of corticosteroids and all additional immunosuppressives, except cyclosporine or tacrolimus, for treatment of acute GVHD without subsequent flare by Day 90 post-initiation of therapy and later by discontinuation of all immunosuppressive medications, including cyclosporine or tacrolimus.|Measured at Days 90, 180, and 270 post-treatment|All patients randomized were included in the analysis on an intent-to-treat basis||participants|||Number
714124|NCT00230100|Secondary|Change in Mean Addiction Severity Index Alcohol Composite Score for Women|"This represents the change from baseline in mean composite scores of the Addiction Severity Index (ASI) alcohol section. The ASI was administered at baseline (assessing for the 60 days prior to the baseline interview) and then monthly for months 1-6 (months 1-3 were in-treatment assessments and months 4-6 were post-treatment follow-up assessments), and month 9 (also a post-treatment follow-up assessment). We implemented a general mixed model analysis of variance (MMANOVA), which models the means per group over the respective time period and the covariance between the repeated measures over the assessments. Both the in-treatment and post-treatment time frames were compared to baseline substance use data.
The ASI is a widely employed multidimensional assessment of substance-related problems. Scores range from 0-1 where higher scores reflect higher addiction severity."|In-treatment phase (month 1-3), Post-treatment phase (month 4-6, 9)|Only women were included in this analysis.||units on a scale||Standard Error|Mean
714125|NCT00230100|Secondary|Change in Mean Number of Drinks Per Drinking Day for Women|This represents the change from baseline in the mean number of drinks per drinking day for women. The number of drinks per drinking day was measured using the Timeline Follow-Back at baseline (assessing for the 60 days prior to the baseline interview) and then monthly for months 1-6 (months 1-3 were in-treatment assessments and months 4-6 were post-treatment follow-up assessments), and month 9 (also a post-treatment follow-up assessment). We implemented a general mixed model analysis of variance (MMANOVA), which models the means per group over the respective time period and the covariance between the repeated measures over the assessments. Both the in-treatment and post-treatment time frames were compared to baseline substance use data.|In-treatment phase (month 1-3), Post-treatment phase (month 4-6, 9)|Only women were included in this analysis.||Drinks per drinking day||Standard Error|Mean
714126|NCT00230100|Primary|Change in Mean Number of Drinking Days for Women|This represents the change from baseline in the mean number of drinking days for women. Number drinking days was assessed using the Timeline Follow-Back at baseline (assessing for the 60 days prior to the baseline interview) and then monthly for months 1-6 (months 1-3 were in-treatment assessments and months 4-6 were post-treatment follow-up assessments), and month 9 (also a post-treatment follow-up assessment). We implemented a general mixed model analysis of variance (MMANOVA), which models the means per group over the respective time period and the covariance between the repeated measures over the assessments. Both the in-treatment and post-treatment time frames were compared to baseline substance use data.|In-treatment phase (month 1-3), Post-treatment phase (month 4-6, 9)|Only women were included in this analysis.||Drinking days||Standard Error|Mean
714127|NCT00230100|Primary|Change in Mean Days of Any Substance Use for Women|This represents the change from baseline in the mean number of days per month of any substance use (i.e. drug and/or alcohol). Days of substance use was assessed using the Timeline Follow-Back at baseline (assessing for the 60 days prior to the baseline interview) and then monthly for months 1-6 (months 1-3 were in-treatment assessments and months 4-6 were post-treatment follow-up assessments), and month 9 (also a post-treatment follow-up assessment). We implemented a general mixed model analysis of variance (MMANOVA), which models the means per group over the respective time period and the covariance between the repeated measures over the assessments. Both the in-treatment and post-treatment time frames were compared to baseline substance use data.|In-treatment phase (month 1-3), Post-treatment phase (month 4-6, 9)|Only women were included in this analysis.||Days of any substance use per month||Standard Error|Mean
714128|NCT00230126|Primary|1-year Survival Rate||12 months|||percentage of patients|||Number
714129|NCT00230126|Primary|Time to Progression||Every 12 weeks|||months||95% Confidence Interval|Median
714130|NCT00230126|Primary|Disease Control Rate at 12 Weeks|no progression of disease at 12 weeks from starting treatment|12 weeks|||participants|||Number
714131|NCT00230178|Secondary|Time to Uric Acid Control|Time from the first dose of study drug to the time at which plasma uric acid concentrations were determined <=7.5 mg/dl, measured -4, 4, 24, 48, 72, 96, 120, and 144 hours after infusion.|Day 1 to Day 7|The analysis was performed on a subgroup of patients from the mITT-population with hyperuricemia immediately prior to the first dose of study drug.||Hours||95% Confidence Interval|Median
714132|NCT00230178|Secondary|Plasma Uric Acid|Area under the curve concentration versus time curve extrapolated to infinity (AUC) of plasma uric acid values|Day 1 to Day 7|The analysis was performed on the modified ITT-population with an evaluation of plasma uric acid AUC.||mg*h/dL||Standard Deviation|Mean
714133|NCT00230178|Primary|Plasma Uric Acid Responder|Number of patients responding to treatment defined as plasma uric acid levels at Day 3 through Day 7 <7.5 mg/dl.|Day 3 through Day 7|||Participants|||Number
714134|NCT00230282|Secondary|Duration of Response||105 months|||months||Full Range|Median
714135|NCT00230282|Primary|Number of Subjects Maintaining Partial Response (PR) or Complete Response (CR)|"Response criteria as per the NCI-WG Revised Guidelines for B-CLL
Complete remission:
No lymphadenopathy by physical exam No hepatomegaly or splenomegaly Absence of constitutional symptoms Polymorphonuclear leukocytes > 1,500/uL, Platelets > 100,000/uL, Hemoglobin > 11.0 g/dL Bone marrow aspirate and biopsy normocellular with < 30% lymphocytes Absent lymphoid nodules
Partial remission:
50% decrease in peripheral blood lymphocyte count from the pretreatment baseline value
50% reduction in lymphadenopathy and/or ≥ 50% reduction in the size of the liver and/or spleen AND one or more of the following Polymorphonuclear leukocytes > 1,500/uL or 50% improvement over baseline Platelets > 100,000/uL or 50% improvement over baseline Hemoglobin > 11.0 g/dL or 50% improvement over baseline"|24 weeks|||participants|||Number
714136|NCT00230737|Primary|Peak Melatonin Level|Pharmacokinetic analysis of maximum melatonin level|day 42|||pg/ml||Standard Error|Mean
714137|NCT00230802|Secondary|Proportion of Subjects With Abnormal Thyroid Stimulating Hormone Values When Following an Every 4 Week Monitoring Schedule During Pregnancy.||9 months|||participants|||Number
714138|NCT00230802|Secondary|the Participants in Each Arm Who Required Levothyroxine Dose Adjustments (Either Increased or Decreased) Occurred to Maintain a Euthyroid State||9 months|||participants|||Number
714139|NCT00230802|Primary|Proportion of Patients in Each Treatment Arm Euthyroid Through Gestation|The proportion of patients in each treatment arm euthyroid through gestation|9 months|proportion of patients in each treatment arm euthyroid through gestation||participants|||Number
714140|NCT00224874|Secondary|Incidence of Epstein-Barr Virus (EBV)-Associated Lymphoma||Measured at 9 months|No data collected|||||
714141|NCT00224874|Secondary|Cumulative Incidence of Systemic Infections||Measured at Day 270|||percentage of participants||95% Confidence Interval|Number
714145|NCT00224874|Secondary|Number of Patients With Acute Graft-versus-host Disease (GVHD) Flares at Day 90|Flares were defined as any increase in symptoms of or therapy for acute GVHD after an initial response (i.e., progression from an earlier CR or PR).|Measured at Day 90|All patients randomized were included in the analysis on an intent-to-treat basis||participants|||Number
714146|NCT00224874|Secondary|Proportion of Treatment Failure||Measured at Day 56|||percentage of participants||95% Confidence Interval|Number
714147|NCT00224874|Secondary|Number of Partial Response (PR), Mixed Response (MR), and Progression|Partial response, mixed response, and progression at Day 28 after randomization. Partial response was defined as improvement in one or more organs involved with Graft-Versus-Host Disease (GVHD) symptoms without progression in others. Mixed response was defined as improvement in one or more organs with deterioration in another organ manifesting symptoms of GVHD or development of symptoms of GVHD in a new organ. Progression was defined as deterioration in at least one organ without any improvement in others.|Measured at Day 28|All patients randomized were included in the analysis on an intent-to-treat basis||participants|||Number
714148|NCT00224874|Primary|Number of Complete Response (CR) at Day 28 of Therapy|Complete response at day 28 after randomization. CR was defined as resolution of all signs and symptoms of Graft-Versus-Host Disease (GVHD) in all evaluable organs in comparison to Day 1 scoring.|Measured at Day 28|All patients randomized were included in the analysis on an intent-to-treat basis||participants|||Number
714149|NCT00224952|Secondary|Age-related Changes in Bioactivation|2. To determine if age-related differences exist regarding the ability of pediatric patients to bioactivate carbamazepine or valproate to reactive metabolites. Data provided below reflect the slope of the least squares regression.|urine samples (overnight collections) collected longitudinally through study completion for time frame ranging from 2-5 years|Change in Carbamazepine detoxification as a function of age is determined only in patients in the Carbamazepine Phase 2 arm. Changes in Valproic Acid detoxification as a function of age are determined only in patients in the Valproic Acid Phase 2 arm.||years^(-1)|||Number
714150|NCT00224952|Primary|Drug (Valproic Acid or Carbamazepine) Metabolite Profiles in Urine|1. To examine the individual metabolic profiles of pediatric patients receiving carbamazepine or valproate therapy, in an attempt to determine the identities of the reactive metabolites or, alternatively, the identities of those metabolites that serve as potential precursors to reactive species (e.g., through conjugation with detoxifying compounds such as glutathione).|urine samples (overnight collections) collected longitudinally through study completion for time frame ranging from 2-5 years|Carbamazepine detoxification product (MTHIS) was only measured in the Carbamazepine Phase I and 2 arms. Valproic Acid (NAC) detoxification products were only measured in the Valproic Acid Phase 2 arm. Units of measure for all analytes are nmol per mg creatinine.||nmol per mg creatinine||Standard Deviation|Mean
714151|NCT00225017|Secondary|Changes in LDL Particle Number From Baseline to Week 24|Change in LDL particle number|Baseline to 24 weeks|||nmol/l||Inter-Quartile Range|Median
714152|NCT00225017|Secondary|Change in Total Cholesterol Levels From Baseline to Week 24|Total cholesterol level changes within and between arms|Baseline to 24 weeks|||mg/dL||Inter-Quartile Range|Median
714153|NCT00225017|Primary|Percentage Change in Brachial Artery Flow Mediated (FMD) Vasodilation Between Arms From Baseline to Week 24|Brachial artery reactivity assessed by noninvasively measuring brachial artery diameter and flow velocities in response to overinflated blood pressure cuff (Flow mediated dilation (FMD))in subjects switching to atazanavir and in subjects continuing on a stable antiretroviral regimen|Baseline to week 24|||percentage change||Inter-Quartile Range|Median
714154|NCT00225147|Secondary|Time to Minimal Symptoms|"The time to minimal symptoms was the time to minimal symptoms for an attack, assessed using the Visual Analogue Scale (VAS) score. Symptoms were said to be minimal when the VAS score at all locations was below 20 mm. Assessment timepoints were: baseline, 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours and 48 hours. Time to minimal symtoms has been calculated by using the exact timepoints on which each assessment was performed."|up to 48 hours after study drug administration|"The full analysis set (FAS or mITT) was defined as the set of patients who provided Informed Consent, were randomized and took at least one dose of the study drug administration."||minutes||Full Range|Median
714155|NCT00225147|Primary|Time to Beginning of Relief of Symptoms|"The time to beginning of relief of symptoms at the location that showed the first visual analogue scale (VAS) score decrease of at least 20 mm from baseline score with persistence to the next timepoint, assessment timepoints were taken on pre-scheduled time-points after study drug administration: baseline (0 minutes), 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours and 48 hours. Time to beginning of relief has been calculated as median time, by using the exact timepoints on which each assessment was performed."|up to 48 hours after study drug administration|"The full analysis set (FAS or mITT) was defined as the set of patients who provided Informed Consent, were randomized and took at least one dose of the study drug administration."||minutes||Full Range|Median
714156|NCT00230971|Secondary|Number of Days of Inpatient Healthcare Resource Utilization on or Before Test-of-Cure|Healthcare resource utilization assessment included days of overall inpatient hospitalization, days of primary inpatient hospitalization, days of Intensive Care Unit (ICU) treatment and days of non-ICU inpatient hospitalization|up to 6 weeks|All patients who received at least 1 dose of study drug.||days||Standard Deviation|Mean
714157|NCT00230971|Secondary|Number of Microbiologically Evaluable (ME) Patients by Microbiological Response at Test-of-Cure (TOC) Visit|Microbiological response was assessed at patient level was the combined responses for all baseline isolates identified in intra-abdominal and blood cultures. Eradication=baseline isolate not recovered from primary infection site/blood; Presumed Eradication=No sample for culture, clinical response was cure; Persistence=baseline isolate recovered from primary infection site/blood; Presumed Persistence=No sample available for culture, clinical response was failure; Superinfection=culture from primary infection site with new isolate not identified at baseline, clinical response was failure.|up to 6 weeks|All patients who received ≥1 dose, had clinical evidence of complicated intra-abdominal infection, met all inclusion/exclusion criteria, completed TOC assessment within 8-44 days after last dose, and had a baseline culture with ≥1 identified isolate that was susceptible to both study drugs. Patients with an indeterminate assessment were excluded.||participants|||Number
714587|NCT00233402|Secondary|Proportion of Patients With at Least One CIS Lesion Detected With Blue Light and None Seen With White Light.||Day 0|||percentage of participants||95% Confidence Interval|Number
714158|NCT00230971|Secondary|Number of Microbiologically Evaluable (ME) Patients With a Clinical Response of Cure at Test-of-Cure (TOC) Visit|ME population were subjects who were clinically evaluable and had baseline culture with at least 1 identified isolate that was susceptible to study drug and comparator. The clinical response was assigned by the investigator according to the protocol-specified guidelines. A clinical response of cure was defined as: the test article and the initial intervention (operative and/or radiologically controlled drainage procedure) resolved the intra-abdominal infection.|up to 6 weeks|All patients who received ≥1 dose, had clinical evidence of complicated intra-abdominal infection, met all inclusion/exclusion criteria, completed TOC assessment within 8-44 days after last dose, and had a baseline culture with ≥1 identified isolate that was susceptible to both study drugs. Patients with an indeterminate assessment were excluded.||participants|||Number
714159|NCT00230971|Primary|Number of Clinically Evaluable (CE) Patients With Clinical Response of Cure at the Test-of-Cure (TOC) Visit|CE population were those who completed TOC assessment of cure or failure (but not indeterminate) or, in case of premature discontinuation due to lack of efficacy, had completed end of treatment assessment such that assessment of clinical response could be made. Clinical response was assigned by investigator per protocol-specified guidelines and defined as: test article and initial intervention (operative and/or radiologically controlled drainage procedure) resolved the intra-abdominal infection. TOC performed 10-28 days after last dose of study drug.|up to 6 weeks|All patients who received at least 1 dose of study drug who had clinical evidence of a complicated intra-abdominal infection (cIAI) and completed the test-of-cure (TOC) assessment of cure or failure within 8 to 44 days after the last administration of study article. Patients with an indeterminate assessment were excluded.||participants|||Number
714160|NCT00231062|Secondary|Number of Participants Experiencing Relief of Sinus Symptoms|To gain general insight into the ability of balloon catheter sinus ostial dilation to relieve sinus symptoms, scores from the pre-operative SNOT-20 evaluations were compared to scores from the post-procedure SNOT-20 evaluations at 24 weeks following the procedure. The number of participants who showed aggregate symptom relief are recorded here as having been successfully treated.|Week 24|All patients treated per protocol; includes all subjects not lost to follow-up at 24 weeks and who completed symptom questionnaire||Participants|||Number
714161|NCT00231062|Primary|Number of Participants With Adverse Events Following Sinuplasty Procedure|Adverse event rate at 24 weeks: comprised of all observed peri-operative adverse events which were recorded on dedicated CRFs and any observed or patient-reported post-operative adverse events will be similarly recorded (through 24 week follow-up).|24 weeks|Analysis per protocol; based on subjects not lost to follow-up at 24 weeks||Participants|||Number
714162|NCT00231062|Primary|Number of Sinuses With Patency of Sinus Ostium After Sinuplasty|Patency of sinus ostium after sinuplasty will be determined by nasal endoscopic examination. The investigator will make a clinical judgment as to whether or not this has been achieved.|24 weeks|Analysis per Protocol; based on all sinuses of subjects not lost to follow-up at 24 weeks||Sinuses|Participants||Number
714163|NCT00231114|Other Pre-specified|Hospitalizations for Respiratory Symptoms||12 Months|||Events/Subject/Year|||Number
714164|NCT00231114|Other Pre-specified|Emergency Room Visits for Respiratory Symptoms||12 Months|Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.||Events/Subject/Year||Standard Deviation|Mean
714165|NCT00231114|Other Pre-specified|Unscheduled Physician Office Visits for Respiratory Symptoms||12 Months|Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.||Events/Subject/Year||Standard Deviation|Mean
714166|NCT00231114|Other Pre-specified|Days Lost From Work/School/Other Activities Due to Asthma||12 Months|Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.||Days/Subject/Year||Standard Deviation|Mean
714167|NCT00231114|Other Pre-specified|Percentage of Subjects With Severe Exacerbations Requiring Systemic Corticosteroids|Percent of subjects experiencing worsening of asthma requiring treatment with oral or intravenous corticosteroids, OR a doubling of the baseline inhaled corticosteroid dose for at least 3 days, OR any temporary increase in the dosage of oral corticosteroids for a Subject taking maintenance oral corticosteroids at Study entry.|Baseline, 12 Months|Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.||Percent of Subjects|||Number
714168|NCT00231114|Other Pre-specified|Rate of Severe Exacerbations Requiring Systemic Corticosteroids|Rate of occurrence of worsening of asthma requiring treatment with oral or intravenous corticosteroids, OR a doubling of the baseline inhaled corticosteroid dose for at least 3 days, OR any temporary increase in the dosage of oral corticosteroids for a Subject taking maintenance oral corticosteroids at Study entry.|Baseline, 12 Months|Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.||Events/Subject/Year||Standard Deviation|Mean
714169|NCT00231114|Secondary|Post-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline)|Change between Baseline and 12-month Follow-Up Visit. The FEV1 is the volume of air expired during the first second of a maximal effort expiration started at total lung capacity.|Baseline, 12 Months|Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.||Percent Change||Standard Deviation|Mean
714170|NCT00231114|Secondary|Pre-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline)|Change between Baseline and 12-month Follow-Up Visit. The FEV1 is the volume of air expired during the first second of a maximal effort expiration started at total lung capacity.|Baseline, 12 Months|Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.||Percent Change||Standard Deviation|Mean
714171|NCT00231114|Secondary|Morning Peak Expiratory Flow (amPEF) (Change From Baseline)|Change between Baseline and 12-month Follow-Up Visit. The peak expiratory flow rate measures the maximal rate at which a person can exhale air.|Baseline, 12 Months|Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.||L/Min||Standard Deviation|Mean
714208|NCT00235443|Secondary|Change From Baseline in Average Pain Interference With Sleep (11-point Likert Scale)|Change from Baseline in average pain interference with sleep (11-point Likert scale) where 0=no interference with sleep and 10=worst possible interference with sleep.|Baseline to end of entire treatment phase visit|Safety population are subjects who took at least one dose of lacosamide (LCM).||Units on a scale||Standard Deviation|Mean
714172|NCT00231114|Secondary|Asthma Control Questionnaire (ACQ) Score (Change From Baseline)|Change between Baseline and 12-month Follow-Up Visit. The ACQ is a self-administered patient questionnaire that also includes the patient’s FEV1 value (% Predicted) that assesses individual subject asthma control. The ACQ comprises 6 questions that relate to the patient’s asthma symptoms, activity limitations, and daily rescue bronchodilator use, and FEV1. Each question is scored from 0 (Better) to 6 (Worse). A decrease in the ACQ score indicates better asthma control.|Baseline, 12 Months|Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.||Units on a scale||Standard Deviation|Mean
714173|NCT00231114|Secondary|Percent Days Rescue Medication Used (Change From Baseline)|Change between Baseline and 12-Month Follow-up Visit. Rescue medications for asthma are short-acting beta-agonists that bring quick relief of asthma symptoms.|Baseline, 12 Months|Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.||Percent Change||Standard Deviation|Mean
714174|NCT00231114|Secondary|Number of Puffs of Rescue Medication Used (Change From Baseline)|Change between Baseline and 12-Month Follow-up Visit. Average number of puffs per week. Rescue medications for asthma are short-acting beta-agonists that bring quick relief of asthma symptoms.|Baseline, 12 Months|Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.||Puffs/7 Days||Standard Deviation|Mean
714175|NCT00231114|Secondary|Total Symptom Score (Change From Baseline)|Change from Baseline and 12-month Follow-Up Visit. Total Symptom Score comprises the sum of these six asthma symptom measurements: wheeze during the night, cough during the night, wheeze during the day, cough during the day, breathlessness during the day, and sputum production during the day. Each of these symptoms is scored on a scale of 0 to 3 each day by the subject. The sum of the scores for these 6 symptoms comprises the Total Symptom Score, which measures overall asthma symptoms. The maximum score possible is 18. A lower Total Symptom score represents better asthma control.|Baseline, 12 Months|Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.||Units on a scale||Standard Deviation|Mean
714176|NCT00231114|Secondary|Percent Symptom-Free Days (Change From Baseline)|Change between Baseline and 12-month Follow-Up Visit. Symptom-Free Days were defined as days when Subject reported no cough, wheeze, breathlessness, or sputum during the daytime, and no wheeze, cough, or awakenings due to asthma symptoms during nighttime.|Baseline, 12 Months|Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.||Percent Change||Standard Deviation|Mean
714177|NCT00231114|Primary|Integrated Asthma Quality of Life Questionnaire (AQLQ) Score (Change From Baseline)|"Change between Baseline and the average of 6-, 9-, and 12-month Follow-Up Visits. The AQLQ consists of 32 questions (scale from 1 to 7, where 7 reflects a higher quality of life). An increase in the AQLQ score indicates a better quality of life. The average of the 6-, 9-, and 12-month differences in the AQLQ Score are referred to as the “Integrated AQLQ Score."|Baseline, 12 Months|Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.||Units on a scale||Standard Deviation|Mean
714178|NCT00231153|Secondary|Catheter Colonization (CC)|CC was defined as a positive culture of any catheter segment >= 15 CFU (roll-plate method) or >999 CFU/ml (sonication method) or a positive blood culture drawn via the catheter where the time-to-positivity difference of catheter line vs. peripheral blood >120 minutes (catheter positive first).|study completion|MITT Among Survivors: patients from the MITT population (all ITT patients who did not have a baseline BSI) who did not die on study, or who died and were positive (indeterminate or failure) for catheter colonization prior to death (as determined EC adjudication).||Events|||Number
714179|NCT00231153|Secondary|Microbiologically-confirmed LCSI|MCLCSI is a subset of EC-adjudicated LCSI for any catheter where there is (1) growth of a recognized pathogen from a culture or any purulence or exudate from the same insertion site, or (2) a positive culture of the subcutaneous segment of the catheter meeting criteria for significant colonization.|study completion|MITT among Survivors: patients from the MITT population (all ITT patients who did not have a baseline BSI) who did not die on study, or who died and were positive (indeterminate or failure) for MCLCSI prior to death (as determined by EC adjudication).||Events|||Number
714180|NCT00231153|Primary|Local Catheter Site Infection (LCSI)|LCSI was defined as a study catheter showing any 2 of the following criteria: erythema >= 2; edema >= 2; presence of purulence, pain, or abnormal study catheter site warmth. In addition, an action must have been taken that indicated a LCSI was present.|study completion|MITT among Survivors: patients from the MITT population (all ITT patients who did not have a baseline BSI) who did not die on study, or who died and were positive (indeterminate or failure) for LCSI prior to death (as determined by EC adjudication).||Events|||Number
714181|NCT00231179|Primary|Child Behavior Checklist Attention Subscale, Percentage of Abnormality in Participants|Caregivers completed The Child Behavior Checklist (CBCL) Preschool form from The Achenbach System of Empirically Based Assessment (ASEBA). The CBCL is standardized for children ages 1.5 to 5 years and measures child internalizing and externalizing behaviors and total problems. Respondents are asked to rate 99 problem items as 0 for “not true of the child,” 1 for “somewhat or sometimes true of the child,” and 2 for “very true or often true of the child” based on the past two months. The range of possible values is 0-100. Percentage of Participants with Abnormal Behavior is calculated by: % abnormal = # of Abnormal / (# of Normal + # of abnormal).|child age 5 years (plus or minus 1 month)|||Percentage of participants|||Number
714182|NCT00231179|Primary|Child Behavior Checklist Aggressive Subscale, Percentage of Abnormality in Participants|Caregivers completed The Child Behavior Checklist (CBCL) Preschool form from The Achenbach System of Empirically Based Assessment (ASEBA). The CBCL is standardized for children ages 1.5 to 5 years and measures child internalizing and externalizing behaviors and total problems. Respondents are asked to rate 99 problem items as 0 for “not true of the child,” 1 for “somewhat or sometimes true of the child,” and 2 for “very true or often true of the child” based on the past two months. The range of possible values is 0-100. Percentage of Participants with Abnormal Behavior is calculated by: % abnormal = # of Abnormal / (# of Normal + # of abnormal).|at child age of 5 years (plus or minus 1 month)|||Percentage of participants|||Number
714209|NCT00235443|Secondary|Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Surface Pain|Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with surface pain where 0=no surface pain and 10=most intense surface pain imaginable.|Baseline to Termination Visit|Safety population are subjects who took at least one dose of lacosamide (LCM).||Units on a scale||Standard Deviation|Mean
714183|NCT00231179|Primary|Child Behavior Checklist Externalizing Scale, Percentage of Abnormality in Participants|Caregivers completed The Child Behavior Checklist (CBCL) Preschool form from The Achenbach System of Empirically Based Assessment (ASEBA). The CBCL is standardized for children ages 1.5 to 5 years and measures child internalizing and externalizing behaviors and total problems. Respondents are asked to rate 99 problem items as 0 for “not true of the child,” 1 for “somewhat or sometimes true of the child,” and 2 for “very true or often true of the child” based on the past two months. The range of possible values is 0-100. Percentage of Participants with Abnormal Behavior is calculated by: % abnormal = # of Abnormal / (# of Normal + # of abnormal).|at child age of 5 years (plus or minus 1 month)|||percentage of participants|||Number
714184|NCT00231179|Primary|Child Behavior Checklist Internalizing Scale at 5 Years of Age, Percentage of Participants|Caregivers completed The Child Behavior Checklist (CBCL) Preschool form from The Achenbach System of Empirically Based Assessment (ASEBA). The CBCL is standardized for children ages 1.5 to 5 years and measures child internalizing and externalizing behaviors and total problems. Respondents are asked to rate 99 problem items as 0 for “not true of the child,” 1 for “somewhat or sometimes true of the child,” and 2 for “very true or often true of the child” based on the past two months. The range of possible values is 0-100. Percentage of Participants with Abnormal Behavior is calculated by: % abnormal = # of Abnormal / (# of Normal + # of abnormal).|at child age of 5 years (plus or minus 1 month)|Number of mothers/caregivers evaluated at 60 month visit.||percentage of participants|||Number
714185|NCT00231179|Primary|Wechsler Preschool and Primary Scale of Intelligence, Third Edition (WPPSI-III)|Cognitive ability was assessed through the Wechsler Preschool and Primary Scale of Intelligence, Third Edition (WPPSI-III). The WPPSI-III has been developed and standardized for children ages 2 years, 6 months through 7 years, 3 months of age. The WPPSI-III yields a Verbal Score, a Performance Score, a General Language Score, and a Full Scale Score. These scores have a mean of 100 and a standard deviation of 15. The range of possible values is 50 (worst value) to 150 (best value).|5 years of age (plus or minus 1 month)|Number of children evaluated at 60 month visit.||Scores on a scale||Standard Deviation|Mean
714186|NCT00234494|Secondary|Duration of Response for Responding Patients|To estimate duration of response for responding patients.|36 months|Data for this secondary outcome measure was not collected or analyzed.|||||
714187|NCT00234494|Secondary|Estimate Response Rates|To estimate rate of partial response (PR), complete response (CR) and overall response (PR plus CR).|36 months|||percentage of participants|||Number
714188|NCT00234494|Secondary|Overall Survival Time|To estimate overall survival time in months.|36 months|||months||95% Confidence Interval|Median
714189|NCT00234494|Primary|Progression Free Survival|- To determine the progression free survival of patients with metastatic transitional cell cancer treated with cisplatin, gemcitabine and bevacizumab.|36 months|||months||95% Confidence Interval|Median
714190|NCT00234832|Secondary|Risk of Experiencing Cardiovascular Death Included in the POE|For each subject, the time to cardiovascular death included in the POE was evaluated using time-to-event analysis.|From randomization up to 6 years|Analysis based on ITT population, which consists of all randomized subjects dispensed randomized study drug and grouped according to the intervention to which they were randomized.||Participants|||Number
714191|NCT00234832|Secondary|Risk of Experiencing a Resuscitated Cardiac Arrest Included in the POE|For each subject, the time to first occurrence of a resuscitated cardiac arrest included in the POE was evaluated using time-to-event analysis.|From randomization up to 6 years|Analysis based on ITT population, which consists of all randomized subjects dispensed randomized study drug and grouped according to the intervention to which they were randomized.||Participants|||Number
714192|NCT00234832|Secondary|Risk of Experiencing a Nonfatal Stroke Included in the POE|For each subject, the time to first occurrence of a nonfatal stroke included in the POE was evaluated using time-to-event analysis.|From randomization up to 6 years|Analysis based on ITT population, which consists of all randomized subjects dispensed randomized study drug and grouped according to the intervention to which they were randomized.||Participants|||Number
714193|NCT00234832|Secondary|Risk of Experiencing a Nonfatal MI Included in the POE|For each subject, the first occurrence of a nonfatal MI included in the POE was evaluated using time-to-event analysis.|From randomization up to 6 years|Analysis based on ITT population, which consists of all randomized subjects dispensed randomized study drug and grouped according to the intervention to which they were randomized.||Participants|||Number
714194|NCT00234832|Secondary|Risk of Experiencing a POE or a Revascularization Procedure|This outcome includes nonfatal MI, nonfatal stroke, resuscitated cardiac arrest, CV death (including events such as fatal MI and fatal stroke), and any of the following revascularization procedures: percutaneous transluminal coronary angioplasty, coronary artery bypass graft, coronary artery stent placement, cardiac transplant, peripheral vascular bypass or angioplasty, and carotid endarterectomy. For each subject, the POE or revascularization status (yes/no) and time to first occurrence of an event using time-to-event analysis were evaluated.|From randomization up to 6 years|Analysis based on ITT population, which consists of all randomized subjects dispensed randomized study drug and grouped according to the intervention to which they were randomized.||Participants|||Number
714195|NCT00234832|Secondary|Risk of Death From Any Cause (All-cause Mortality)|For each subject who died, the time to death was evaluated using time-to-event analysis.|From randomization up to 6 years|Analysis based on ITT population, which consists of all randomized subjects dispensed randomized study drug and grouped according to the intervention to which they were randomized.||Participants|||Number
714196|NCT00234832|Primary|Risk of Experiencing a Primary Outcome Event (POE) (i.e., Nonfatal Myocardial Infarction [MI], Nonfatal Stroke, Resuscitated Cardiac Arrest, Cardiovascular [CV] Death)|For each subject, POE status (with/without an event) and time to first occurrence of a POE using time-to-event analysis were evaluated. All POE confirmed by an independent adjudication committee were included in the analysis.|From randomization up to 6 years|Analysis based on intent-to-treat (ITT) population, which consists of all randomized subjects dispensed randomized study drug and grouped according to the intervention to which they were randomized. Subjects were also categorized into 1 of 3 prespecified CV risk groups: diabetes mellitus (DM) only, CV only, and CV + DM.||Participants|||Number
714307|NCT00236951|Primary|Change From Baseline to the Maximum Hemoglobin Level During Stage 2 (Week 9 Through Week 21).|The hemoglobin baseline was defined as the average of the last 2 hemoglobin values during stage 1 (through week 8).|During Stage 2 (week 9 through week 21)|intention to treat (ITT)||g/dL||Standard Deviation|Mean
714197|NCT00234884|Primary|Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI)|HAQ-DI is a composite measure of physical function calculated on the basis of 20 questions in 8 domains (dressing, arising, eating, walking, hygiene, reach, grip, and common activities), each evaluated on a 4-point scale ranging from 0 (without any difficulty) to 3 (unable to do). HAQ-DI score is the sum of worst scores in each domain divided by the number of domains answered, and ranges from 0 (no difficulty) to 3 (unable to do). A mean change of -0.22 is considered the minimum clinically important change. Mean change in HAQ-DI was calculated from Baseline of NCT00448383 (Study M02-497).|Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value|Results are presented as observed. The number of participants evaluated is indicated for each time point below.||units on a scale||Standard Deviation|Mean
714198|NCT00234884|Primary|American College of Rheumatology 70% (ACR70) Response Rate|ACR70 response is a 70% or better improvement from Baseline in tender joint count, swollen joint count, and at least 3 of the following 5 parameters: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire Disability Index (HAQ-DI), and C-reactive protein. Response was calculated based on values at Baseline of NCT00448383 (Study M02-497).|Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value|Results are presented as observed. The number of participants evaluated is indicated for each time point below.||participants|||Number
714199|NCT00234884|Primary|American College of Rheumatology 50% (ACR50) Response Rate|ACR50 response is a 50% or better improvement from Baseline in tender joint count, swollen joint count, and at least 3 of the following 5 parameters: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire Disability Index (HAQ-DI), and C-reactive protein. Response was calculated based on values at Baseline of NCT00448383 (Study M02-497).|Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value|Results are presented as observed. The number of participants evaluated is indicated for each time point below.||percentage of participants|||Number
714200|NCT00234884|Primary|American College of Rheumatology 20% (ACR20) Response Rate|ACR20 response is a 20% or better improvement from Baseline in tender joint count, swollen joint count, and at least 3 of the following 5 parameters: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire Disability Index (HAQ-DI), and C-reactive protein. Response was calculated based on values at Baseline of NCT00448383 (Study M02-497).|Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value|Results are presented as observed. The number of participants evaluated is indicated for each time point below.||percentage of participants|||Number
714201|NCT00234884|Primary|Disease Activity Score in 28 Joints (DAS28) Based on Erythrocyte Sedimentation Rate (ESR)|DAS28 is a composite measure of disease activity in patients with rheumatoid arthritis. It is calculated on the basis of tender and swollen joint counts (each assessed in 28 joints), the patient's ESR, and the patient's subjective assessment of disease activity (assessed using a 100-mm visual analog scale). A DAS28 less than 3.2 indicates low disease activity and a DAS28 greater than 5.1 indicates high disease activity; there is no absolute range of scores due to inter-patient variability in ESR.|Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value|Results are presented as observed. The number of participants evaluated is indicated for each time point below.||units on a scale||Standard Deviation|Mean
714202|NCT00235326|Primary|Number of Participants With Post Infectious Irritable Bowel Syndrome||8 years|||participants|||Number
714203|NCT00235391|Secondary|The Change in Serum Ferritin Values From Baseline Through Completion of the Study|The number of participants with Improvement, No Change or Worsening in Serum ferritin category levels at the end of the study compared to baseline. Serum ferritin levels in µg/L were divided into to 6 categories: (<1000), (1000-<2500), (2500-<4000), (4000-<5500), (5500-<7000) and (>=7000). Improvement was defined as a shift to a lower category at the end of study compared to the category at baseline. Worsening was defined as a shift to a higher category at the end of the study compared to the category at baseline. No change was no change in category at end of study from baseline.|Baseline to end of study (Median exposure time to drug was approximately 30 weeks; Maximum exposure was 104 weeks)|Safety population defined as all participants who received at least one dose of study drug. This analysis did not include participants with unknown status at baseline and/or at the end of the study.||Participants|||Number
714204|NCT00235391|Primary|Safety Profile of Deferasirox Based Upon Drug Administration and Reporting of Serious Adverse Events|Safety as assessed by the number of participants with death, serious adverse events (SAE), and/or Adverse Events (AEs) leading to study drug interruption or discontinuation. Note: only treatment emergent AEs are summarized.|Baseline to end of study (Median exposure time to drug was approximately 30 weeks; Maximum exposure was 104 weeks)|The safety population, comprising all participants who received at least one dose of deferasirox during the study, was used in the analyses.||Participants|||Number
714205|NCT00235443|Secondary|Change From Baseline in Quality of Life Using the SF-36 Health Survey – Mental Component Summary (MCS)|Change from Baseline in quality of life using the SF-36 Health Survey – Mental Component Summary (MCS). Values range from 0 to 100 with high values indicating a good condition. Positive change in baseline values indicate improvement in quality of life.|Baseline to Termination Visit|Safety population are subjects who took at least one dose of lacosamide (LCM).||Units on a scale||Standard Deviation|Mean
714206|NCT00235443|Secondary|Change From Baseline in Quality of Life Using the SF-36 Health Survey - Physical Component Summary (PCS)|Change from Baseline in quality of life using the SF-36 Health Survey - Physical Component Summary (PCS). Values range from 0 to 100 with high values indicating a good condition. Positive change in baseline values indicate improvement in quality of life.|Baseline to Termination Visit|Safety population are subjects who took at least one dose of lacosamide (LCM).||Units on a scale||Standard Deviation|Mean
714207|NCT00235443|Secondary|Change From Baseline in Average Pain Interference With Activity (11-point Likert Scale)|Change from Baseline in average pain interference with activity (11-point Likert scale) where 0=no interfence with activity and 10=worst possible interference with activity.|Baseline to end of entire treatment phase visit|Safety population are subjects who took at least one dose of lacosamide (LCM).||Units on a scale||Standard Deviation|Mean
714308|NCT00236977|Secondary|Mean Change From Baseline in Hemoglobin (g/dL) at Day 56||Change from Baseline at Day 56|Intent to Treat (ITT) population exclusions: Venofer - 12 subjects excluded; Ferrous Sulfate - 9 subjects excluded; due to either no post-baseline efficacy data, or unstable use of erythropoietin during the eight weeks prior to randomization.||g/dL||Standard Deviation|Mean
714210|NCT00235443|Secondary|Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Deep Pain|Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with deep pain where 0=no deep pain and 10=most intense deep pain sensation imaginable.|Baseline to Termination Visit|Safety population are subjects who took at least one dose of lacosamide (LCM).||Units on a scale||Standard Deviation|Mean
714211|NCT00235443|Secondary|Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Unpleasantness|"Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with unpleasantness where 0=not pleasant and 10=most unpleasant sensation imaginable (intolerable)."|Baseline to Termination Visit|Safety population are subjects who took at least one dose of lacosamide (LCM).||Units on a scale||Standard Deviation|Mean
714212|NCT00235443|Secondary|Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Itchiness|"Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with itchiness where 0=not itchy and 10=most itchy sensation imaginable (like poison oak)."|Baseline to Termination Visit|Safety population are subjects who took at least one dose of lacosamide (LCM).||Units on a scale||Standard Deviation|Mean
714213|NCT00235443|Secondary|Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Sensitivity|"Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with sensitivity of pain where 0=not sensitive and 10=most sensitive sensation imaginable (raw skin)."|Baseline to Termination Visit|Safety population are subjects who took at least one dose of lacosamide (LCM).||Units on a scale||Standard Deviation|Mean
714214|NCT00235443|Secondary|Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Cold|"Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with cold sensation where 0=not cold and 10=most cold sensation imaginable (freezing)."|Baseline to Termination Visit|Safety population are subjects who took at least one dose of lacosamide (LCM).||Units on a scale||Standard Deviation|Mean
714215|NCT00235443|Secondary|Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Dullness|Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with dullness of pain where 0=not dull and 10=most dull sensation imaginable.|Baseline to Termination Visit|Safety population are subjects who took at least one dose of lacosamide (LCM).||Units on a scale||Standard Deviation|Mean
714216|NCT00235443|Secondary|Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Heat|"Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with heat sensation where 0=not hot and 10=the most hot sensation imaginable (on fire)."|Baseline to Termination Visit|Safety population are subjects who took at least one dose of lacosamide (LCM).||Units on a scale||Standard Deviation|Mean
714217|NCT00235443|Secondary|Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Sharpness|"Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) for sharpness of pain where 0=not sharp and 10=most sharp sensation imaginable (like a knife)."|Baseline to Termination Visit|Safety population are subjects who took at least one dose of lacosamide (LCM).||Units on a scale||Standard Deviation|Mean
714218|NCT00235443|Secondary|Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Intensity.|Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) for intensity of pain where 0=no pain and 10=most intense pain sensation imaginable.|Baseline to Termination Visit|Safety population are subjects who took at least one dose of lacosamide (LCM).||Units on a scale||Standard Deviation|Mean
714219|NCT00235443|Secondary|Patient’s Global Impression of Change (PGIC) From Baseline in Pain.|Patient’s Global Impression of Change (PGIC) from Baseline in Pain. Original categorical responses are much worse, moderately worse, mildly worst, no change, mildly better, moderately better, and much better. Reported results are presented as Better (sum of mildly, moderately, or much better), No Change, or Worse (sum of mildly, moderately, or much worse).|Baseline to Termination Visit|Safety population are subjects who took at least one dose of lacosamide (LCM).||Participants|||Number
714220|NCT00235443|Secondary|Change From Baseline in Average Pain Score as Measured by a 100mm Visual Analogue Scale (VAS).|Change from Baseline in average pain score as measured by a 100mm Visual Analogue Scale (VAS). On VAS 0mm=no pain and 100mm=worst possible pain.|Baseline to end of entire treatment phase (maximum study period of 2.8 years).|Safety population are subjects who took at least one dose of lacosamide (LCM).||Units on a scale||Standard Deviation|Mean
714221|NCT00235443|Secondary|Change From Baseline in Average Daily Pain Score Using an 11-point Likert Scale (0-10).|Change from Baseline in average daily pain score using an 11-point Likert scale (0-10). On Likert scale, 0=no pain and 10=worst possible pain.|Baseline to end of entire treatment phase (maximum study period of 2.8 years).|Safety population are subjects who took at least one dose of lacosamide (LCM).||Units on a scale||Standard Deviation|Mean
714222|NCT00235443|Primary|Number of Subjects With Adverse Events (AEs) Reported Spontaneously by the Subject or Observed by the Investigator.|Number of subjects with adverse events (AEs) reported spontaneously by the subject or observed by the investigator (serious and non-serious).|Throughout the study up to a maximum study period of 2.8 years|Safety population are subjects who took at least one dose of lacosamide (LCM).||Participants|||Number
714223|NCT00235456|Secondary|Hospital Length of Stay|The number of days patient stayed in the hospital after surgery.|time to hospital discharge after surgery|||days||Standard Deviation|Mean
714224|NCT00235456|Secondary|Staples Removed|Time to staples removed, measured in days|time to event after surgery|||days||Standard Deviation|Mean
714225|NCT00235456|Secondary|First Solid Food Intake|Time to restarting feeding after surgery, measured in days.|time to event after surgery|||days||Standard Deviation|Mean
714226|NCT00235456|Secondary|Return to Ambulation|time to return to ambulation after surgery, measured in days|time to event after surgery|||days||Standard Deviation|Mean
714227|NCT00235456|Secondary|Return of Bowel Function|Time to return of bowel function, measured in days.|time to event after surgery to discharge from hospital|||days||Standard Deviation|Mean
714228|NCT00235456|Primary|Incisional Surgical Wound Infection|Surgical wounds were defined as infected if they met Centers for Disease Control and Prevention definitions.|0 to 14 days after surgery|||participants|||Number
714229|NCT00235573|Secondary|Total Transcobalamin Measured at Intervals From Baseline to 48 Hours.||Baseline through 48 hours at intervals of 0, 0.5, 1.5, 2.5, 3.5, 4.5, 5.5, 6, 7, 8, 9, 10, 11, 11.5, 12.5, 24, 48||||||
714230|NCT00235573|Primary|Change in Holo-transcobalamin|Holo-TC is a vitamin B12 carrier protein. Only vitamin B12 bound to holo-TC can be taken up by cells. Changes in holo-TC after an oral dose of vitamin B12 may provide a clinical test to assess vitamin B12 absorption. The change in holo-transcobalamin (holo-TC) from baseline was measured at timed intervals in response to supplemental vitamin B12 and compared to baseline. The purpose was to ascertain the time point at which holo-TC reaches the maximum concentration in the blood following a dose of vitamin B12 in subjects without defects in vitamin B12 absorption.|Holo-transcobalamin measured at 24 hours after baseline|The number of participants for analysis was per protocol.||pmol/L||Standard Deviation|Mean
714231|NCT00235716|Other Pre-specified|All-cause Mortality|Survival analysis of death from any cause.|up to 4 years|Intention-to-treat analysis that includes all randomized participants.||participants|||Number
714232|NCT00235716|Primary|Caregiver Activity Survey Change From Baseline|The Caregiver Activity Survey (CAS) was developed to measure the time caregivers spend aiding Alzheimer patients with their day-to-day activities. The CAS consists of six items that ask for an estimate in hours and minutes of the time that the caregiver spent during the previous 24 hours performing these particular activities. The six CAS items are as follows: 1) communication with the person, 2) using transportation, 3) dressing, 4) eating, 5) looking after one's appearance, and 6) supervising the person. The more caregiving hours the worse the patient's functioning level. Outcome analysis is average least square means change from baseline.|6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline|Intention-to-treat analysis that includes all participants with baseline and at least one follow-up measurement.||hours per day||Standard Error|Least Squares Mean
714233|NCT00235716|Primary|Neuropsychiatric Inventory Change From Baseline|The Neuropsychiatric Inventory (NPI) assesses psychological and behavioral problems in patients with dementia. For each of twelve domains, there are four scores: frequency, severity, total frequency x severity, and caregiver distress. The frequency x severity total scores from each domain are summed for an overall total score that ranges from 0 to 144. The total caregiver distress scores are also summed for an overall total caregiver distress score that ranges from 0 to 60. The secondary endpoint for the trial will be the overall frequency times severity total score. Outcome analysis is average least square means change from baseline.|6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline|Intention-to-treat analysis that includes all participants with baseline and at least one follow-up measurement.||units on a scale||Standard Error|Least Squares Mean
714234|NCT00235716|Primary|Alzheimer's Disease Assessment Scale - Cognitive (ADAS-cog) Change From Baseline|The Alzheimer's Disease Assessment Scale (ADAS) is a 21-item scale designed to assess the severity of cognitive and non-cognitive behavioral impairments in patients with Alzheimer's disease. The cognitive portion of the scale (ADAS-cog) consists of 11 items to assess memory, language, and praxis functions. The ADAS-cog total score ranges from 0 (no errors) to 70 (severe cognitive impairment). Outcome analysis is average least square means change from baseline.|6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline|Intention-to-treat analysis that includes all participants with baseline and at least one follow-up measurement.||units on a scale||Standard Error|Least Squares Mean
714235|NCT00235716|Primary|Mini-Mental State Examination Change From Baseline|The Mini-Mental State Examination (MMSE) briefly and objectively assess cognitive status in psychiatric patients with cognitive impairment. The MMSE questions are grouped into seven categories, each representing a different cognitive domain. The MMSE yields a total score that ranges from 0 for a patient who gives no correct response to a score of 30 for a patient who makes no errors. Outcome analysis is average least square means change from baseline.|6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline|Intention-to-treat analysis that includes all participants with baseline and at least one follow-up measurement.||units on a scale||Standard Error|Least Squares Mean
714236|NCT00235716|Secondary|Dependence Scale: Time to Event Analysis (Increase of of One Dependence Level)|The Dependence Scale assesses the level of assistance needed by patients with Alzheimer's disease for activities of daily living. The scale yields six levels of dependence: no assistance required (Level 0); requires occasional reminders (Level 1); requires frequent reminders and/or help with household chores (Level 2); needs daily supervision (Level 3); needs to be dressed, toileted or fed (Level 4); needs to be transferred, diapered or tube fed (Level 5).|Every 6 months to a maximum of 4 years|Intention-to-treat analysis that includes all participants with baseline and at least one follow-up measurement.||participants|||Number
714237|NCT00235716|Primary|Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL) Inventory Change From Baseline|The primary outcome of the study was the Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL) Inventory. The ADCS/ADL Inventory is designed to assess functional abilities to perform activities of daily living in Alzheimer patients with a broad range of dementia severity. The total score ranges from 0 to 78 with higher scores indicating greater abilities. Outcome analysis is average least square means change from baseline.|6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline|Intention-to-treat analysis that includes all participants with baseline and at least one follow-up measurement.||units on a scale||Standard Error|Least Squares Mean
714238|NCT00235755|Secondary|Number of Participants With a >=7% Increase in Body Weight During Weeks 2 and 4 of theTitration Phase and Weeks 6, 8, 12, and 16 of the Maintenance Phase|The number of participants with recorded weight gain of >=7% over their baseline weight was measured.|Weeks 2 and 4 of Titration Phase and Weeks 6, 8, 12, and 16 of Maintenance Phase|Safety Population. Only participants who remained in the study at the indicated week and who also had a body weight assessment were analyzed.||participants|||Number
714239|NCT00235755|Secondary|Change From Baseline in Post-void Residual Urine Volume at Weeks 8 and 16 of the Maintenance Phase|Post-void residual (PVR) urine refers to the amount of urine remaining in the bladder after normal urination. To investigate the possible effects of retigabine on bladder function, all participants underwent post-void residual bladder ultrasound at Baseline and during the Maintenance Phase. The PVR bladder ultrasound was performed by a urologist, a qualified ultrasound technician, or a qualified study nurse who was certified to do PVR bladder ultrasound. Change from Baseline in PVR residual volume was calculated as the values at Week 10 and Week 16 minus the value at Baseline.|Baseline (Week -7 through 0), Weeks 8 and 16|Safety Population. Only participants who remained in the study at the indicated week and who also had a PVR assessment were analyzed.||milliliters||Full Range|Median
714314|NCT00236977|Primary|Patients With an Increase in Hemoglobin >= 1gm/dL.||Change from Baseline up to Day 56|Intent to Treat (ITT) population exclusions: Venofer - 12 subjects excluded; Ferrous Sulfate - 9 subjects excluded; due to either no post-baseline efficacy data, or unstable use of erythropoietin during the eight weeks prior to randomization.||participants|||Number
714240|NCT00235755|Secondary|Number of Participants Who Reported the Indicated Renal and Urinary Disorder Adverse Events at a Frequency Threshold of 2% (in Any Treatment Arm)|A summary of the adverse events classified as renal or urinary disorders and in which at least 2% (rounded to an integer) of participants in any treatment arm reported during the study is presented.|Week 1 through Week 16|Safety Population||participants|||Number
714241|NCT00235755|Secondary|Number of Participants Whose Clinical Laboratory Values Were Deemed an Adverse Event by the Investigator (>=2% in Any Treatment Arm)|Clinically important changes in laboratory values were to be reported as an adverse event if they met one of the following criteria: (1) intervention required; (2) change in dose of study drug required; (3) other treatment/therapy required; (4) association with other diagnoses.|Week 1 through Week 16|Safety Population||participants|||Number
714242|NCT00235755|Secondary|Quality of Life Assessed by Quality of Life in Epilepsy-Problems Questionnaire (QOLIE-31-P) at BL (Week 0) and Weeks 4, 8, and 16|The QOLIE-31-P is a 31-item questionnaire evaluating a participant's QOL perception in 7 domains: seizure worry, emotional well being, energy/fatigue, cognitive functioning, medication effects, social functioning, overall QOL. Precoded numeric values for some domains are such that a higher number reflects a more favorable health state; others are such that a higher number reflects a less favorable state. Precoded values are first converted to 0-100 point scores; higher converted scores always reflect better QOL. The overall score is derived by weighting and then summing the 7 domain scores.|End of Baseline (Week 0), Weeks 4, 8, and 16|Safety Population: all randomized participants who received at least 1 dose of retigabine or placebo. Only participants with QOLIE-31-P data were included in the analysis.||scores on a scale||Standard Deviation|Mean
714243|NCT00235755|Secondary|Patient Global Impression (PGI) Score at the End of the Maintenance Phase|PGI is a participant-rated scale of improvement that was administered at the end of the Maintenance Phase in order to assess the participant's impression of his or her own improvement. PGI assessments were scored using a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.|Week 16/end of treatment phase|ITT EMEA Population. Only participants with post-baseline PGI scores were included in the analysis.||scores on a scale||Standard Deviation|Mean
714244|NCT00235755|Secondary|Clinical Global Impression-Improvement (CGI-I) Score at the End of the Maintenance Phase|Clinical Global Impression of Improvement (CGI-I) is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the treatment. Scores on the scale are rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.|Week 16/end of treatment phase|ITT EMEA Population||scores on a scale||Standard Deviation|Mean
714245|NCT00235755|Secondary|Percentage of Seizure-free Days During the Maintenance Phase|A seizure-free day was a day without any seizures. The percentage of seizure-free days was calculated as the total number of days without seizures in the Maintenance Phase divided by the number of days in the Maintenance Phase x 100%.|Week 5 through Week 16|ITT EMEA Population||percentage of days||Full Range|Median
714246|NCT00235755|Secondary|Percentage of Seizure-free Days During the DB Phase (Titration and Maintenance Phases)|A seizure-free day was a day without any seizures. For a participant to be seizure free during the DB Phase, the participant had to be seizure free both Week 7 to Week 18 and Week 1 to Week 6. A participant could be seizure free Week 7 to Week 18 (during the Maintenance Phase), but not seizure free Week 1 to Week 6. Hence, there are fewer participants being reported as seizure free from Week 1 to Week 18 than from Week 7 to Week 18. The percentage of seizure-free days was calculated as the total number of days without seizures in the DB period divided by the number of days in DB period x 100%.|Week 1 through Week 16|ITT FDA Population. Only participants who had post-baseline seizure data were included in the analysis.||percentage of days||Full Range|Median
714247|NCT00235755|Secondary|Number of Participants Who Were Seizure-free During the Maintenance Phase|Participants were considered to be seizure-free if they had not reported any seizures during the Maintenance Phase.|Week 5 through Week 16|ITT EMEA Population||participants|||Number
714248|NCT00235755|Secondary|Number of Participants Who Were Seizure-free During the DB Phase (Titration and Maintenance Phases)|Participants were considered to be seizure-free if they had not reported any seizures during the DB treatment period (Weeks 1-18). For a participant to be seizure free during the DB Phase, the participant had to be seizure free both Week 7 to Week 18 and Week 1 to Week 6. A participant could be seizure free Week 7 to Week 18 (during the Maintenance Phase), but not seizure free Week 1 to Week 6. Hence, there are fewer participants being reported as seizure free from Week 1 to Week 18 than from Week 7 to Week 18.|Week 1 through Week 16|ITT FDA Population. Only participants with post-baseline seizure data were included in the analysis.||participants|||Number
714249|NCT00235755|Secondary|Number of Participants Reporting New Seizure Types in the Indicated Categories During the DB Phase (Titration and Maintenance Phases) That Were Not Reported at Baseline|New seizure types included those seizures which were not reported by any participant at Baseline.|Baseline (Week -7 through Week 0), Week 1 through Week 16|ITT FDA Population||participants|||Number
714250|NCT00235755|Secondary|Number of Participants Who Experienced the Indicated Level of Exacerbation and Reduction in the 28-day Total Partial Seizure Frequency From Baseline During the Maintenance Phase|Participants who experienced an exacerbation from Baseline in the 28-day total partial seizure frequency were categorized as having a 0-25% or a >25% increase (EMEA endpoint). The number of participants experiencing a >0% reduction from Baseline in the 28-day total partial seizure frequency are also presented.|Baseline (Week -7 through Week 0), Week 5 through Week 16|ITT EMEA Population||participants|||Number
714251|NCT00235755|Secondary|Number of Participants With the Indicated Reduction From Baseline in the 28-day Total Partial Seizure Frequency During the Maintenance Phase|Participants who experienced a reduction from Baseline in the 28-day total partial seizure frequency were categorized as having a >75%, a 50-75%, or a <50% reduction, in addition to having no reduction (EMEA endpoint).|Baseline (Week -7 through Week 0), Week 5 through Week 16|ITT EMEA Population||participants|||Number
714309|NCT00236977|Secondary|Mean Change From Baseline in Serum Transferrin Saturation (TSAT) (%) at Day 56||Change from Baseline at Day 56|Intent to Treat (ITT) population exclusions: Venofer - 12 subjects excluded; Ferrous Sulfate - 9 subjects excluded; due to either no post-baseline efficacy data, or unstable use of erythropoietin during the eight weeks prior to randomization.||percentage of change||Standard Deviation|Mean
714310|NCT00236977|Secondary|Mean Change in Ferritin (ng/mL) From Baseline to Day 56||Change from Baseline at Day 56|||ng/mL||Standard Deviation|Mean
714252|NCT00235755|Secondary|Number of Participants With a Reduction in the 28-day Total Partial Seizure Frequency From Baseline to the DB Phase (Titration and Maintenance Phases) by Indicated Decile Reduction and Increase Categories|Participants who experienced a reduction from Baseline in the 28-day total partial seizure frequency were categorized in decile cutting, i.e., reduction categories of 90-100%, 80-<90%, 70-<80%, 60-<70%, 50-<60%, 40-<50%, 30-<40%, 20-<30%, 10-<20%, >0-<10%, and increase categories of 0-10%, >10-20%, >20-30%, >30% (FDA endpoint). Participants without any post-baseline data were included in the category 0-10% increase category.|Baseline (Week -7 through Week 0), Week 1 through Week 16|ITT FDA Population||participants|||Number
714253|NCT00235755|Secondary|Number of Participants With a Reduction in the 28-day Total Partial Seizure Frequency From Baseline to the End of DB Phase (Titration and Maintenance Phases) by Indicated Quartile Reduction Categories|"Participants who experienced a reduction from Baseline in the 28-day total partial seizure frequency were categorized as having a reduction of 75-100%, 50-<75%, 25-<50%, or <25%, in addition to having no reduction. This quartile cutting was specified in the study protocol. Participants without any post-baseline data are included in the No reduction category."|Baseline (Week -7 through Week 0), Week 1 through Week 16|ITT FDA Population||participants|||Number
714254|NCT00235755|Secondary|Percent Change From Baseline (BL) in the 28-day Total Partial Seizure Frequency During the Maintenance Phase|28-day total partial seizure frequency in the BL period = (No. of total partial seizures reported in the BL period divided by the No. of days of available total partial seizure data in the BL period) x 28 days. 28-day total partial seizure frequency in the Maintenance Phase = (No. of total partial seizures reported in the Maintenance Phase divided by the No. of days of available total partial seizure data in the same phase) x 28 days. Percent change = (value in the Maintenance Phase minus value at BL divided by the BL value) x 100%. Negative values indicate a reduction in seizure frequency.|Baseline (Week -7 through Week 0), Week 5 through Week 16|ITT EMEA Population||Percent change in seizure frequency||Full Range|Median
714255|NCT00235755|Secondary|Number of Participants Who Were Responders and Non-responders During the DB Phase|Responders were participants with at least a 50% reduction in the 28-day total partial seizure frequency in the DB Phase as compared to the Baseline period. Participants without any post-baseline data were considered non-responders.|Week 1 through Week 16|ITT FDA Population||participants|||Number
714256|NCT00235755|Primary|Number of Participants Classified as Responders and Non-responders During the Maintenance Phase|Responders were participants with at least a 50% reduction in the 28-day total partial seizure frequency in the Maintenance Phase as compared to the Baseline period.|Week 5 through Week 16|ITT European Medicines Evaluation Agency (EMEA) Population: all randomized participants who had received at least 1 dose of study drug in the Maintenance Phase and had at least 1 seizure measurement (whether or not they had a seizure) recorded in the Maintenance Phase.||participants|||Number
714257|NCT00235755|Primary|Percent Change in the 28-day Total Partial Seizure (PS) Frequency From Baseline (BL) to the End of the Double-blind (DB) Phase (Titration and Maintenance Phases)|28-day total PS (PSs [also called focal seizures] are seizures limited to a specific area of the brain) frequency in the BL period = (Number [No.] of total PSs reported in the BL period divided by the No. of days of available total PS data in the BL period) x 28 days. 28-day total PS frequency in the DB period = (No. of total PSs reported in the DB period divided by the No. of days of available total PS data in the DB period) x 28 days. Percent change = ([value in the DB period minus value at BL] divided by the BL value) x 100%. Negative valu es indicate a reduction in seizure frequency.|Baseline (Week -7 through Week 0), DB Phase (Week 1 through Week 16)|Intent-to-Treat Food and Drug Administration (ITT FDA) Population: all randomized participants (P) who received at least 1 dose of study drug. Only participants with post-BL seizure data are included in this analysis.||percent change in seizure frequency||Full Range|Median
714258|NCT00235833|Secondary|Number of Subjects With Morning Stiffness at Each Visit|The number of subjects with morning stiffness (assessed as present or absent) at each visit among those who had morning stiffness at baseline (21).|Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)|Subjects analyzed (as-observed) include only those who had morning stiffness at baseline.||participants|||Number
714259|NCT00235833|Secondary|Area Under the Curve (AUC; From Start of the Study to Each Study Visit) of Subjects' Who Improved at Least 20% in ACR Response Criteria (ACR20 Response)|Sum of the duration (from start of study to each study visit) when a subject with American College of Rheumatology (ACR) criteria improved by 20% (ACR20) in tender or swollen joint counts [TJC or SJC, respectively] and 20% improvement in 3 of the following 5 criteria: [1] Physician's global assessment (PGA), [2] subject's assessment of disease activity, [3] subject's assessment of pain, [4] subject's assessment of functional disability via a health assessment questionnaire [HAQ], and [5] C-reactive protein (CRP)|Every 6 weeks up to Week 24 and every 12 weeks thereafter|||Weeks||Standard Deviation|Mean
714260|NCT00235833|Secondary|Mean Change From Baseline in C-reactive Protein [CRP; mg/dL], a Component of the ACR Criteria, by Visit.|Mean change from baseline (last assessment in preceding study prior to adalimumab injection) in C-reactive protein [CRP; mg/dL], a component of the ACR criteria, by visit.|Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)|||mg/dL||Standard Deviation|Mean
714261|NCT00235833|Secondary|Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire [HAQ], a Component the of ACR Criteria, by Visit|Mean change from baseline (last assessment in preceding study prior to adalimumab injection) in disability index of the health assessment questionnaire [HAQ; includes 20 questions assessing physical function in 8 domains. The questions are evaluated on a scale from 0 - 3 to measure the ability to perform certain activities (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do so).], a component the of ACR criteria, by visit|Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)|||units on a scale||Standard Deviation|Mean
714262|NCT00235833|Secondary|Mean Change From Baseline (Last Assessment in Preceding Study Prior to Adalimumab Injection) in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Pain), a Component of the ACR Criteria, by Visit|Mean change from baseline (last assessment in preceding study prior to adalimumab injection) in subject's assessment of pain (using a visual analog scale from 0 - 100 mm with 100 mm being the worst possible pain), a component of the ACR criteria, by visit|Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)|||mm on scale||Standard Deviation|Mean
714263|NCT00235833|Secondary|Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit|Mean change from baseline (last assessment in preceding study prior to adalimumab injection) in subject's global assessment of disease activity (a visual analog scale from 0 - 100 mm with 100 mm being the worst case), a component of the ACR criteria, by visit|Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)|||mm on scale||Standard Deviation|Mean
714264|NCT00235833|Secondary|Mean Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit|Mean change from baseline (last assessment in preceding study prior to adalimumab injection) in PGA (a visual analog scale from 0 - 100 mm with 100 mm being the worst possible assessment), a component of the ACR criteria, by visit.|Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)|||mm on scale||Standard Deviation|Mean
714265|NCT00235833|Secondary|Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria, by Visit|Mean change from baseline(last assessment in preceding study prior to adalimumab injection) in the SJC (max = 66) component of the ACR criteria|Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)|||SJC||Standard Deviation|Mean
714266|NCT00235833|Secondary|Mean Change From Baseline in Tender Joint Count (TJC, Max = 68), a Component of the ACR Criteria, by Visit|Mean change from baseline (last assessment in preceding study prior to adalimumab injection) in tender joint count (TJC, max = 68), a component of the ACR criteria, by visit|Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)|||TJC||Standard Deviation|Mean
714267|NCT00235833|Primary|Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)|Number of subjects with American College of Rheumatology (ACR) criteria improvement consisting of 20%, 50%, and 70% (ACR20, ACR50, and ACR70, respectively) reduction in tender or swollen joint counts [TJC or SJC, respectively] and 20%, 50%, and 70% improvement, respectively, in 3 of the following 5 criteria: [1] physician's global assessment of disease activity [PGA], [2] subject's assessment of disease activity, [3] subject's assessment of pain, [4] subject's assessment of functional disability via a health assessment questionnaire [HAQ], and [5] C-reactive protein [CRP]) at each visit|Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)|Analysis was based on observed data.||participants|||Number
714268|NCT00235872|Secondary|Mean Change From Baseline in Rheumatoid Factor (IU/ML) by Visit|Mean change from Baseline in RF (IU/mL). For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 [before dosing] of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 [before dosing] of the M03-651 study.|Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)|Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.||IU/mL||Standard Deviation|Mean
714269|NCT00235872|Secondary|Presence of Rheumatoid Factor (RF)|The number of subjects who were positive for rheumatoid factor (RF) at each visit. RF considered negative if <=20 IU/mL and positive if >20 IU/mL.|Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)|Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.||participants|||Number
714270|NCT00235872|Secondary|Mean Change From Baseline in the Duration (Minutes) of Morning Stiffness by Visit|Mean change (minutes) from Baseline in morning stiffness (duration). For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 [before dosing] of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 [before dosing] of the M03-651 study.|Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)|Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.||minutes||Standard Deviation|Mean
714271|NCT00235872|Secondary|Presence of Morning Stiffness|The number of subjects with morning stiffness at each visit. For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 [before dosing] of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 [before dosing] of the M03-651 study.|Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)|Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.||participants|||Number
714272|NCT00235872|Secondary|Mean Change From Baseline in C-reactive Protein (CRP), a Component of the American College of Rheumatology (ACR) Criteria by Visit|Mean change from Baseline in CRP (mg/dL), a component of the ACR criteria by visit. For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 [before dosing] of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 [before dosing] of the M03-651 study.|Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)|Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.||mg/dL||Standard Deviation|Mean
714311|NCT00236977|Secondary|Highest Change From Baseline in Ferritin (ng/mL) up to Day 56||Change from Baseline up to Day 56|Only subjects who completed the study from the Intent to Treat (ITT) population.||ng/mL||Standard Deviation|Mean
714312|NCT00236977|Secondary|Highest Change From Baseline in Hemoglobin (g/dL) up to Day 56||Change from Baseline up to Day 56|Only subjects who completed the study from the Intent to Treat (ITT) population.||g/dL||Standard Deviation|Mean
714654|NCT00240227|Secondary|Change in Blood Pressure Response in Response to Provocative Visual Cues Designed to Elicit Craving, Compared to Placebo Group||During lab session||||||
714273|NCT00235872|Secondary|Mean Change From Baseline in the Disability Index of the Health Assessment Questionaire (DI-HAQ, a Component of the American College of Rheumatology (ACR) Criteria by Visit|Mean change from Baseline in DI-HAQ overall score (includes 20 questions assessing physical function in 8 domains - dressing, rising, eating, walking, hygiene, reach, grip, and usual activities). Each question is on a scale of 0-3 mm to measure the ability to perform certain activities (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do so), a component of the ACR criteria by visit. DI-HAQ is derived based on the mean of individual responses not the total of individual questions|Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)|Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.||mm on a scale||Standard Deviation|Mean
714274|NCT00235872|Secondary|Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale, a Component of the ACR Criteria by Visit|Change from Baseline in subject's assessment of pain (a visual analog scale from 0-100 mm [0 being no pain and 100 being unbearable pain], a component of the ACR criteria by visit). For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 (before dosing) of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 (before dosing) of the M03-651 study.|Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value).|Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.||mm on unit scale||Standard Deviation|Mean
714275|NCT00235872|Secondary|Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale, a Component of the ACR Criteria by Visit|Change from Baseline in Subject's Global Assessment of Disease Activity (a visual analog scale from 0-100 mm (0 being absence of disease activity and 100 being very strong disease activity), a component of the ACR criteria by visit). For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 (before dosing) of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 (before dosing) of the M03-651 study.|Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value).|Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.||mm on unit scale||Standard Deviation|Mean
714276|NCT00235872|Secondary|Mean Change From Baseline in Physician Global Assessment of Disease Activity (PGA), a Component of the ACR Criteria by Visit|Change from Baseline in PGA (a visual analog scale from 0-100 mm, with 0 being the absence of disease activity and 100 mm being very strong disease activity, a component of the ACR criteria by visit). For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 (before dosing) of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 (before dosing) of the M03-651 study.|Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value).|Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.||mm on a scale||Standard Deviation|Mean
714277|NCT00235872|Secondary|Mean Change From Baseline in Swollen Joint Count (SJC, Max=66), a Component of the American College of Rheumatology (ACR) by Visit|Mean change from Baseline in SJC (max=66) at each visit, a component of ACR. For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 (before dosing)] of the M02-575 study; for the M02-575 rescue arm, the baseline was defined as the Week 0 (before dosing) of the M03-651 study.|Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)|Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.||SJC||Standard Deviation|Mean
714278|NCT00235872|Secondary|Mean Change From Baseline in Tender Joint Count (TJC, Max=68), a Component of the American College of Rheumatology (ACR) by Visit|Mean change from Baseline in TJC (max=68) at each visit, a component of ACR. For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 [before dosing] of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 [before dosing] of the M03-651 study.|Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)|Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.||TJC||Standard Deviation|Mean
714279|NCT00235872|Primary|Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)|Number of responders with ACR criteria improvement consisting of 20%, 50%, and 70% (ACR20/50/70, respectively) reduction in tender or swollen joint counts (TJC or SJC, respectively) and 20%, 50%, and 70% improvement, respectively, in 3 of the following 5 criteria: 1) physician's global assessment of disease activity (PGA), 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire (DI-HAQ), and 5) C-reactive protein (CRP) at each visit.|Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)|Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.||participants|||Number
714313|NCT00236977|Secondary|Number of Subjects With a Clinical Response|Clinical Response (change in Hemoblobin (Hgb) >= 1gm/dL and change in ferritin >= 160ng/ml)|Change from Baseline up to Day 56|Intent to Treat (ITT) population exclusions: Venofer - 12 subjects excluded; Ferrous Sulfate - 9 subjects excluded; due to either no post-baseline efficacy data, or unstable use of erythropoietin during the eight weeks prior to randomization.||participants|||Number
714655|NCT00240227|Secondary|Change in Heart Rate Response in Response to Provocative Visual Cues Designed to Elicit Craving, Compared to Placebo Group||During lab session||||||
714280|NCT00235989|Secondary|Frequency (Number of Patients Per Group Defined by Cut Off Values and Per Treatment Arm) of Neutralizing Antibody (NAb) Titer to IFNB-1b|Serum samples for analysis of NAbs to interferon (IFN) beta-1b were collected in Study 307000A. In the extension study, NAbs were also monitored for information on persistence or resolution. Serum samples of about 6 mL for NAbs were drawn at Weeks 10, 24, 52, 78, 104 130, 156, 182, 208, 234, 260, 286 or the EOS visit. (NU/ml=neutralizing units/ml).|At End of Study Visit (week 234)|For the NAb analyses data were provided for 40 patients instead of 61 for week 234. Twenty-one patients had no data at this visit.The entries in the table are the number of patients with positive titer in the extension treatment cohorts for the three cutoff titer values. The analyses provide frequencies of positive titers.||participants|||Number
714281|NCT00235989|Primary|Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities|Outcome measures are given as the number of patients with common toxicity by the Common Toxicity Criteria (CTC). Toxicity grading is: Grade 1: no study drug action recommended, Grade 2: Dose reduction or interruption of study treatment should be considered (grade 2 Lymphocyte toxicity required no study drug action), Grade 3: Dose reduction or interruption should be considered; interruption is recommended, and Grade 4: Interruption of study drug is recommended (Grade 4 laboratory toxicity was reported as a serious adverse event). Liver and bone marrow abnormalities are measured by lab tests.|At End of Study Visit (week 234)|The statistical analysis was descriptive. For Liver Function Toxicity grading, the total number of patients for 250 micrograms (mcg) - 500 mcg group was 19 instead of 20 for all analyses.||participants|||Number
714282|NCT00236080|Primary|Psychomotor Vigilance Task (PVT)|The computer-based PVT took 10 minutes to complete and measured reaction time stimulus in milliseconds. The reaction time consisted of the digits 000 initially appearing in a window on the PVT device, after which the 3-digit numbers increased in milliseconds until the response button was pressed by the patient. The resulting number at the button press was the reaction time in milliseconds. There was a variable 1- to 10-second interstimulus interval. After pressing the button in response to each stimulus, the button was released and the patient awaited the next stimulus.|Endpoint (Visit 4) change from baseline (Visit 2)|Of the patients who completed the study, 1 patient in the PROVIGIL 200 mg/day treatment group and 1 patient in the Armodafinil 150 mg/day treatment group did not complete their PVT assessment.||Milliseconds||Standard Deviation|Mean
714283|NCT00236080|Primary|Multiple Sleep Latency Test (MSLT)|The Multiple Sleep Latency Test (MSLT) is an objective assessment of sleepiness that measures the likelihood of falling asleep. Five 20-minute (maximum) MSLT naps were performed (at 2300, 0100, 0300, 0500, and 0700) at both the screening/baseline assessment visit (Visit 2) and at endpoint (Visit 4). Each nap was terminated after 20 minutes if no sleep occurred. Sleep latency was measured as the elapsed time from lights out to the first epoch scored as sleep.|Endpoint (Visit 4) change from baseline (Visit 2)|"1 Placebo Patient did not have an MSLT but did complete the other Primary Measure (PVT) and other requirements. This patient was termed a Completer.
1 Patient in the Armodafinil 200 mg/day group had an MSLT performed but then discontinued the study drug before reaching the study endpoint and was termed a Non-Completer for the Study."||Minutes||Standard Deviation|Mean
714284|NCT00236184|Primary|Complete Heartburn Relief During the First Full 24-Hour Period in the ITT Population.|"Subject was considered complete relief if he/she did not heartburn during the nighttime of the first dose date and no heartburn during the daytime of 1 day after the first dose date. The difference in complete relief within the first 24 hours between treatment groups was tested using a continuity corrected chi-square test without adjustment baseline heartburn severity."|first 24 hours|The primary analysis will be on the intent-to-treat (ITT)population. ITT population includes all randomized subjects who received at least one dose of study drug and had at least one post-baseline assessment.||participants|||Number
714285|NCT00236184|Secondary|Change From Baseline in Average Belching Severity Score Between Placebo and Rabeprazole.|comparison between placebo and treatment will be analyzed using two-sample t-test.|14-day treatment period.||||||
714286|NCT00236184|Secondary|Change From Baseline in Average Regurgitation Severity Score Between Placebo and Rabeprazole.|comparison between placebo and treatment will be analyzed using two-sample t-test.|14-day treatment period.||||||
714287|NCT00236184|Secondary|Summary of Percentage of Heartburn-Free Nighttimes,Intent-to-Treat (ITT) Population|comparison between placebo and treatment will be analyzed using two-sample t-test.|14-day treatment period.||||||
714288|NCT00236184|Secondary|Summary of Percentage of Heartburn-free Daytimes, Intent-to-Treat (ITT) Population|comparison between placebo and treatment will be analyzed using two-sample t-test.|14-day treatment period.||||||
714289|NCT00236197|Secondary|Change From Baseline in Average Belching Severity Score Between Placebo and Rabeprazole||14 day randomized treatment period||||||
714290|NCT00236197|Secondary|Change From Baseline in Average Regurgitation Severity Score Between Placebo and Rabeprazole||14 day randomized treatment period||||||
714291|NCT00236197|Secondary|Summary of Percentage of Heartburn-Free Nighttimes||14-day randomized treatment period||||||
714292|NCT00236197|Secondary|Summary of Percentage of Heartburn-Free Daytimes|comparison between placebo and treatment will be analyzed using two-sample t-test.|14-day treatment period.||||||
714293|NCT00236197|Primary|Complete Heartburn Relief During the First Full 24-Hour Period in Intent-to-Treat (ITT) Population|The difference in complete relief within the first 24 hours between treatment and placebo in ITT was tested using a continuity corrected chi-square test withput adjustment for baseline severity.|First 24 hours|The primary analysis will be on the intent-to-treat (ITT)population. ITT population includes all randomized subjects who received at least one dose of study drug and had at least one post-baseline assessment.||Participants|||Number
714294|NCT00236899|Secondary|Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at 30-Day Post-therapy Visit|RSSC is a valid and reliable measure of psychological and physical distress of cancer patients. Overall QOL is assessed on a 7-point scale (1=Excellent to 7=Extremely Poor). Categories include Excellent, Good, Moderately Good, Neither Good nor Bad, Rather Poor, Poor, and Extremely Poor. Number of responses to the overall QOL (using the 7-point scale) by treatment arm are provided.|Baseline up to 51.64 months|Intent to treat (ITT) population defined as all randomized participants.||participants|||Number
714656|NCT00240227|Primary|Change in Skin Conductance Response in Response to Provocative Visual Cues Designed to Elicit Craving, Compared to Placebo Group||During lab session|Study was terminated early. No final analyses completed.|||||
714295|NCT00236899|Secondary|Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at Beginning of 3-Week or 4-Week Cycle|RSSC is a valid and reliable measure of psychological and physical distress of cancer patients. Overall QOL is assessed on a 7-point scale (1=Excellent to 7=Extremely Poor). Categories include Excellent, Good, Moderately Good, Neither Good nor Bad, Rather Poor, Poor, and Extremely Poor. Number of responses to the overall QOL by treatment arm are provided. Arms A (Docetaxel and Gemcitabine 3 Weekly) and B (Paclitaxel and Gemcitabine 3 Weekly) were assessed every 3 weeks. Arms C (Docetaxel and Gemcitabine Weekly) and D (Paclitaxel and Gemcitabine Weekly) were assessed every 4 weeks.|Baseline up to 51.64 months|Intent to treat (ITT) population defined as all randomized participants.||participants|||Number
714296|NCT00236899|Secondary|Number of Participants With Serious and Nonserious Adverse Events (AEs)|Summary tables of serious adverse events (SAEs) and all other nonserious AEs are located in the Reported Adverse Event Module.|Baseline up to 51.64 months|Intent to treat (ITT) population defined as the population of all randomized participants.||participants|||Number
714297|NCT00236899|Secondary|Overall Response Rate(ORR) by Treatment Drug|Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response≥30% decrease in sum of longest diameter of target lesions; Progressive Disease≥20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. Not Available=participants assessed whose data were not available. Not Assessed=participants who did not participate in assessments. The ORR=sum of complete and partial tumor responses observed, divided by the total number of evaluable participants.|Baseline up to 49.84 months|All randomized participants treated with at least 1 dose of Docetaxel, Paclitaxel or Gemcitabine. Treatment arms based on Treatment Drug (Docetaxel+Gemcitabine vs Paclitaxel+Gemcitabine) were combined for this population.||percentage of responses|||Number
714298|NCT00236899|Primary|Time to Progressive Disease (TTPD) by Treatment Drug|"TTPD is defined as the time from the day of treatment to first observation of documented disease progression or death due to any cause, whichever comes first. TTPD was censored at the time of last follow-up for patients who were still alive without progression. Tumor response was assessed in cancer patients by using Response Evaluation Criteria in Solid Tumors (RECIST), which define when cancer patients improve (respond), stay the same (stabilize), or worsen (progression) during treatments. Progressive Disease is a ≥20% increase in sum of longest diameter of target lesions."|Baseline up to 49.84 months|ITT population defined as the population of all randomized participants. Treatment arms based on Treatment Drug (Docetaxel+Gemcitabine vs Paclitaxel+Gemcitabine) were combined for this population. A total of 33 (13.7%) participants were censored with 17 (13.68%) in the Docetaxel+Gemcitabine arm and 18 (13.71%) in the Paclitaxel+Gemcitabine arm.||months||95% Confidence Interval|Median
714299|NCT00236899|Secondary|Overall Response Rate (ORR) by Treatment Schedule|Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response≥30% decrease in sum of longest diameter of target lesions; Progressive Disease≥20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. Not Available=participants assessed whose data were not available. Not Assessed=participants who did not participate in assessments. The ORR=sum of complete and partial tumor responses observed, divided by the total number of evaluable participants.|Baseline up to 49.84 months|All randomized patients treated with at least 1 dose of Docetaxel, Paclitaxel or Gemcitabine. Treatment arms based on treatment schedule (Weekly vs 3 Weekly) were combined for this population.||percentage of responses|||Number
714300|NCT00236899|Secondary|Overall Survival (OS) by Treatment Drug|OS is the duration from enrollment to time of death as a result of any cause. For participants who are alive, OS is censored at the last contact (date of the last follow-up visit).|Baseline up to 51.64 months|ITT population defined as the population of all randomized participants. Treatment arms based on Treatment Drug (Docetaxel+Gemcitabine vs Paclitaxel+Gemcitabine) were combined for this population. A total of 109 participants were censored with 55 (46.61%) in the Docetaxel+Gemcitabine arm and 54 (43.90%) in the Paclitaxel+Gemcitabine arm.||months||95% Confidence Interval|Median
714301|NCT00236899|Secondary|Overall Survival (OS) by Treatment Schedule|OS is the duration from enrollment to time of death as a result of any cause. For participants who are alive, OS is censored at the last contact (date of the last follow-up visit).|Baseline up to 51.64 months|Intention to treat (ITT) population defined as the population of all randomized participants. Treatment arms based on treatment schedule (Weekly vs 3 Weekly) were combined for this population. A total of 109 (45.2%) participants were censored with 53 (45.3%) in the Weekly arm and 56 (45.2%) participants in the 3 Weekly arm.||months||95% Confidence Interval|Mean
714302|NCT00236899|Primary|Time to Progressive Disease (TTPD) by Treatment Schedule|"TTPD is defined as the time from the day of treatment to first observation of documented disease progression or death due to any cause, whichever comes first. TTPD was censored at the time of last follow-up for patients who were still alive without progression. Tumor response was assessed in cancer patients by using Response Evaluation Criteria in Solid Tumors (RECIST), which define when cancer patients improve (respond), stay the same (stabilize), or worsen (progression) during treatments. Progressive Disease is a ≥20% increase in sum of longest diameter of target lesions."|Baseline up to 49.84 months|Intention to treat (ITT) population is defined as the population of all randomized participants. Treatment arms based on treatment schedule (Weekly vs 3 Weekly) were combined for this population. A total of 33 participants were censored with 16 (13.68%)in the Weekly arm and 17 (13.71%) participants in the 3 Weekly arm.||months||95% Confidence Interval|Median
714303|NCT00236938|Secondary|The Mean Change From Baseline to the Highest Reticulocyte Count up to Day 71||Change from Baseline up to Day 71|Intent-to-Treat Population (ITT)||percentage of change||Standard Deviation|Mean
714304|NCT00236938|Secondary|The Mean Change From Baseline to the Highest Ferritin up to Day 71||Change from Baseline up to Day 71|Intent-to-Treat Population (ITT)||ng/mL||Standard Deviation|Mean
714305|NCT00236938|Secondary|The Mean Change From Baseline to the Highest Serum Transferrin Saturation (TSAT) up to Day 71||Change from Baseline up to Day 71|Intent-to-Treat Population (ITT)||percentage of change||Standard Deviation|Mean
714306|NCT00236938|Primary|Mean Change From Baseline to the Highest Hemoglobin up to Day 71||Change from Baseline up to Day 71|Intent-to-Treat Population (ITT): All safety population subjects who received at least 1 dose of study medication or EPO and had at least 1 post-baseline efficacy measurement.||g/dL||Standard Deviation|Mean
714315|NCT00237042|Secondary|Number of Participants With Pain-Related Activity Interference|Degree to which pain interferes with: daily activities, work and household activities, recreational activities (mean of 3 0-10 ratings); dichotomized as presence/absence of pain-related activity interference|12 months|Participants with 12 month follow up data. Intention to treat analysis.||participants|||Number
714316|NCT00237042|Primary|Characteristic Pain Intensity (Characteristic Intensity of Facial Pain)|Average of 0-10 ratings of current facial pain, average facial pain in the last month and worst facial pain in the last month, where 0 is no pain and 10 is pain as bad as could be. For the combined outcome, the minimum score is 0 and maximum is 10, with 0 being better (no pain) and 10 being the worst outcome.|12 months|Participants with 12 month follow up data. Intention to treat analysis.||Units on a scale||Standard Deviation|Mean
714317|NCT00237042|Secondary|Number of Participants With Pain-Related Activity Interference|Degree to which pain interferes with: daily activities, work and household activities, recreational activities (mean of 3 0-10 ratings); dichotomized as presence/absence of pain-related activity interference|6 Months|Participants with 6 month follow up data. Intention to treat analysis.||participants|||Number
714318|NCT00237042|Primary|Characteristic Pain Intensity (Characteristic Intensity of Facial Pain)|Average of 0-10 ratings of current facial pain, average facial pain in the last month and worst facial pain in the last month, where 0 is no pain and 10 is pain as bad as could be. For the combined outcome, the minimum score is 0 and maximum is 10, with 0 being better (no pain) and 10 being the worst outcome.|6 months|Participants with 6 month follow up data. Intention to treat analysis.||units on a scale||Standard Deviation|Mean
714319|NCT00237185|Secondary|Time to Progression (Core + Extension)|Time to progression was analyzed as time to event for all participants. Participants who had neither progressed, died nor discontinued from the trial for any reason other than the condition no longer required therapy were censored for analysis at the time of their last tumor assessment.|Date of first imatinib dose to date of progression or death due to disease indication or discontinuation due to unsatisfactory therapeutic effect during the core and extension periods, up to 156 months.|Treatment population: the treatment population included all participants who received at least one dose of study medication.||months||95% Confidence Interval|Median
714320|NCT00237185|Secondary|Time to Onset of Response (Core + Extension)|Time to response was analyzed as time to event for all participants. Participants who did not meet the definition of confirmed PR/CR were censored at the time of their last progression-free tumor assessment.|Date of first imatinib dose to the date of the first tumor assessment that was later confirmed to be at least a partial response during the core and extension periods, up to 156 months.|Treatment population: the treatment population included all participants who received at least one dose of study medication.||months||95% Confidence Interval|Median
714321|NCT00237185|Secondary|Time to Onset of Response (Core)|Time to response was analyzed as time to event for all participants. Participants who did not meet the definition of confirmed PR/CR were censored at the time of their last progression-free tumor assessment.|Date of first imatinib dose to the date of the first tumor assessment that was later confirmed to be at least a partial response during the core period, up to 36 months.|Treatment population: the treatment population included all participants who received at least one dose of study medication.||weeks||95% Confidence Interval|Median
714322|NCT00237185|Secondary|Time to Treatment Failure (Core + Extension)|Time to treatment failure was analyzed as time to event for all participants. Participants who had neither progressed, died nor discontinued from the trial for any reason other than the condition no longer required therapy were censored for analysis at the time of their last tumor assessment.|Date of first imatinib dose to date of earliest occurrence of progression, death due to any cause, or discontinuation from the trial for any reason other than the condition no longer required therapy during the core and extension periods, up to 156 month.|Treatment population: the treatment population included all participants who received at least one dose of study medication.||months||95% Confidence Interval|Median
714323|NCT00237185|Secondary|Time to Treatment Failure (Core)|Time to treatment failure was analyzed as time to event for all participants. Participants who had neither progressed, died nor discontinued from the trial for any reason other than the condition no longer required therapy were censored for analysis ate the time of their last tumor assessment.|Date of first imatinib dose to date of earliest occurrence of progression, death due to any cause, or discontinuation from the trial for any reason other than the condition no longer required therapy during the core period, up to 36 months.|Treatment population: the treatment population included all participants who received at least one dose of study medication.||weeks||95% Confidence Interval|Median
714324|NCT00237185|Secondary|Progression Free Survival (PFS) (Core + Extension)|Progression free survival was analyzed as a time to event for each participant. If a participant had no event, then the PFS was censored at the last tumor assessment.|Date of first imatinib dose to earliest date of progression, resection due to safety/progression, death due to any cause or discontinuation due to unsatisfactory therapeutic effect during the core and extension periods, up to 156 months.|Treatment population: the treatment population included all participants who had at least one dose of study medication.||months||95% Confidence Interval|Median
714325|NCT00237185|Secondary|Duration of Response (Core + Extension)|Duration of response was analyzed as time to event for all participants whose best response was at least a PR. The onset of response was the first tumor assessment that was subsequently confirmed to constitute at least a partial best response. The end of response was the first tumor assessment noting PD.|Date of confirmed best PR or CR to date of confirmed disease progression during the core and extension periods, up to 156 months|Treatment population: the treatment population included all participants who had at least one dose of study medication and whose best response was at least a PR.||months||95% Confidence Interval|Median
714326|NCT00237185|Secondary|Duration of Response (Core)|Duration of response was analyzed as time to event for all participants whose best response was at least a PR. The onset of response was the first tumor assessment that was subsequently confirmed to constitute at least a partial best response. The end of response was the first tumor assessment noting PD.|Date of confirmed best PR or CR to date of confirmed disease progression during the core period, up to 36 months.|Treatment population: the treatment population included all participants who had at least one dose of study medication and whose best response was at least a PR.||weeks||95% Confidence Interval|Median
714984|NCT00247273|Secondary|Percent Change From Baseline in Serum CTX at Month 24, ITT Population|Assayed by electrochemiluminescent immunoassay.|Baseline to Month 24|ITT||Percent Change||95% Confidence Interval|Least Squares Mean
714327|NCT00237185|Secondary|Overall Survival (Core + Extension)|Overall survival was analyzed as time to event for all participants. Participants who did not die were censored at the last date known alive, which is the last date of any study medication, laboratory sample, tumor assessment, adverse event end date or date of last contact.|Date of first imatinib dose to the date of death during the core and extension periods, up to 156 months.|Treatment population: the treatment population included all participants who had at least one dose of study medication.||months||95% Confidence Interval|Median
714328|NCT00237185|Secondary|Overall Survival (Core)|Overall survival was analyzed as time to event for all participants. Participants who did not die were censored at the last date known alive, which is the last date of any study medication, laboratory sample, tumor assessment, adverse event end date or date of last contact.|Date of first imatinib dose to the date of death during the core period, up to 36 months.|Treatment population: the treatment population included all participants who had at least one dose of study medication.||months||95% Confidence Interval|Median
714329|NCT00237185|Primary|Best Tumor Response (Core + Extension)|Best tumor response was based on the Southwestern Oncology Group (SWOG) criteria. Objective tumor response assessments were categorized according to the following criteria: complete response (CR), partial response (PR), no change or stable disease (SD), progression of disease (PD), unknown where the progression has not been documented and one or more measurable or evaluable sites have not been assessed (UNK), status after resection for progression (RP), status after resection for safety (RS), status after preventive resection (RPR), progressive after first resection (PDR) and not evaluable. Any tumor assessment after surgical resection for preventative reasons was treated like tumor assessments of UNK for calculation of best response. Tumor assessments with current objective status = RP, RS or PDR were treated like assessments with objective tumor status = PD n the calculation of best response.|Month 156|Treatment population: the treatment population included all participants who had at least one dose of study medication.||participants|||Number
714330|NCT00237185|Primary|Best Tumor Response (Core)|Best tumor response was based on the Southwestern Oncology Group (SWOG) criteria. Objective tumor response assessments were categorized according to the following criteria: complete response (CR), partial response (PR), no change or stable disease (SD), progression of disease (PD), unknown where the progression has not been documented and one or more measurable or evaluable sites have not been assessed (UNK), status after resection for progression (RP), status after resection for safety (RS), status after preventive resection (RPR), progressive after first resection (PDR) and not evaluable. Any tumor assessment after surgical resection for preventative reasons was treated like tumor assessments of UNK for calculation of best response. Tumor assessments with current objective status = RP, RS or PDR were treated like assessments with objective tumor status = PD n the calculation of best response.|Month 36|Treatment population: The treatment population included all randomized participants who received at least one dose of study medication.||participants|||Number
714331|NCT00237458|Secondary|"Percentage of Days With Concomitant Pain (Rescue) Medications Taken During Titration and Treatment Phases."|"The percentage of days where rescue medication was taken is summarized by visit and by Treatment Phase (Baseline, Titration, and Titration + Treatment).
The percentage of days of rescue medication use is defined as the number of days observed within the visit/study phase with rescue medication divided by the number of days in the visit/study phase times 100 for subjects who had taken the rescue medication.
Summary statistics include mean and standard deviation."|From Titration Phase through Treatment Phase (approximately 9 years)|Of the 7 subjects in the Safety Set (SS), 5 are included in this analysis.||percentage of days||Standard Deviation|Mean
714332|NCT00237458|Secondary|Percentage of Days With Concomitant Pain (“Rescue”) Medications Taken During Titration Phase.|"The percentage of days where rescue medication was taken is summarized by visit and by Treatment Phase (Baseline, Titration, and Titration + Treatment).
The percentage of days of rescue medication use is defined as the number of days observed within the visit/study phase with rescue medication divided by the number of days in the visit/study phase times 100 for subjects who had taken the rescue medication.
Summary statistics include mean and standard deviation."|Titration Period (approximately 6 weeks)|Of the 7 subjects in the Safety Set (SS), 4 are included in this analysis.||percentage of days||Standard Deviation|Mean
714333|NCT00237458|Secondary|Percentage of Days With Concomitant Pain (“Rescue”) Medications Taken During Baseline Phase.|"The percentage of days where rescue medication was taken is summarized by visit and by Treatment Phase (Baseline, Titration, and Titration + Treatment).
The percentage of days of rescue medication use is defined as the number of days observed within the visit/study phase with rescue medication divided by the number of days in the visit/study phase times 100 for subjects who had taken the rescue medication.
Summary statistics include mean and standard deviation."|Baseline Period (approximately 1 week)|Of the 7 subjects in the Safety Set (SS), 4 are included in this analysis.||percentage of days||Standard Deviation|Mean
714334|NCT00237458|Secondary|Investigator's Global Impression of Change In Pain During The Treatment Period.|"The Investigator's Global Impression of Change is a physician's assessment of the patient's overall change in relief of neuropathic pain since the beginning of the study rated on a 7-point scale ranging from:
Much better
Moderately better
Mildly better
No change
Mildly worse
Moderately worse
Much worse"|From Baseline Visit to Final Week of Treatment (approximately 9 years)|Of the 7 subjects in the Safety Set (SS), 7 are included in this analysis.||percentage of participants|||Number
714335|NCT00237458|Secondary|Subject's Global Impression of Change In Pain During The Treatment Period.|"The Subject's Global Impression of Change is a self-evaluation by the subject of their overall change in relief of neuropathic pain since the beginning of the study rated on a 7-point scale ranging from:
Much better
Moderately better
Mildly better
No change
Mildly worse
Moderately worse
Much worse"|From Baseline Visit to Final Week of Treatment (approximately 9 years)|Of the 7 subjects in the Safety Set (SS), 7 are included in this analysis.||percentage of participants|||Number
714336|NCT00237458|Secondary|Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Allodynia.|"Each individual cardinal symptom of pain is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst possible pain).
Allodynia is defined as neuropathic pain caused by normally innocuous stimuli becoming painful."|From Baseline Visit to Final Week of Treatment (approximately 9 years)|Of the 7 subjects in the Safety Set (SS), 7 are included in this analysis.||units on a scale||Standard Deviation|Mean
714985|NCT00247273|Secondary|Change From Baseline in Serum CTX at Month 24, ITT Population|Assayed by electrochemiluminescent immunoassay.|Baseline to Month 24|ITT||ng / mL||95% Confidence Interval|Least Squares Mean
714337|NCT00237458|Secondary|Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Numbness.|Each individual cardinal symptom of pain is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst possible pain).|From Baseline Visit to Final Week of Treatment (approximately 9 years)|Of the 7 subjects in the Safety Set (SS), 7 are included in this analysis.||units on a scale||Standard Deviation|Mean
714338|NCT00237458|Secondary|Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Paraesthesiae.|Each individual cardinal symptom of pain is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst possible pain).|From Baseline Visit to Final Week of Treatment (approximately 9 years)|Of the 7 subjects in the Safety Set (SS), 7 are included in this analysis.||units on a scale||Standard Deviation|Mean
714339|NCT00237458|Secondary|Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Burning.|Each individual cardinal symptom of pain is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst possible pain).|From Baseline Visit to Final Week of Treatment (approximately 9 years)|Of the 7 subjects in the Safety Set (SS), 7 are included in this analysis.||units on a scale||Standard Deviation|Mean
714340|NCT00237458|Secondary|Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Shooting.|Each individual cardinal symptom of pain is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst possible pain).|From Baseline Visit to Final Week of Treatment (approximately 9 years)|Of the 7 subjects in the Safety Set (SS), 7 are included in this analysis.||units on a scale||Standard Deviation|Mean
714341|NCT00237458|Secondary|Within-Subject Change In Average Daily Pain Score During the Treatment Period.|The Average Daily Pain Score is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst pain ever experienced).|From Baseline Visit to Final Week of Treatment (approximately 9 years)|Of the 7 subjects in the Safety Set (SS), 7 are included in this analysis.||units on a scale||Standard Deviation|Mean
714342|NCT00237458|Primary|Number of Subjects Withdrawing From Study Due To A Treatment-Emergent Adverse Event (TEAE) During The Treatment Period.||From Baseline Visit to Final Week of Treatment (approximately 10 years)|Of the 7 subjects in the Safety Set (SS), 7 are included in this analysis.||participants|||Number
714343|NCT00237458|Primary|Number of Subjects Reporting At Least 1 Treatment-Emergent Adverse Event (TEAE) During The Treatment Period.||From Baseline Visit to Final Week of Treatment (approximately 10 years)|Of the 7 subjects in the Safety Set (SS), 7 are included in this analysis.||participants|||Number
714344|NCT00237666|Secondary|Mean Change From Baseline in the Total Score of the Beck Depression Inventory (BDI)|Beck Depression Inventory, self-rated scale measuring depression symptoms; possible total scores ranging from 0-63, with higher scores indicating greater severity of depression.|Week 8|Per protocol, the number of participants for analysis was 30 randomized subjects; data analyzed at Week 8 or Last Observation Carried Forward for the 6 subjects who dropped out before completion.||Scores on a scale||Standard Deviation|Mean
714345|NCT00237666|Secondary|Mean Change From Baseline in the Total Score of the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)|Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) scale consists of 14 items; possible scores range from 14-70 with higher scores indicating greater quality of life and satisfaction.|Week 8|Per protocol, the number of participants for analysis was 30 randomized subjects; data analyzed at Week 8 or Last Observation Carried Forward for the 6 subjects who dropped out before completion.||Scores on a scale||Standard Deviation|Mean
714346|NCT00237666|Secondary|Mean Change From Baseline in the CGI-Severity of Illness (CGI-S) Score at Study Endpoint|Clinical Global Impression of Severity scale: one item, measuring overall severity of illness; possible scores range from 1-7, with higher scores representing greater severity of illness.|Week 8|Per protocol, the number of participants for analysis was 30 randomized subjects; data analyzed at Week 8 or Last Observation Carried Forward for the 6 subjects who dropped out before completion.||Score on a scale||Standard Deviation|Mean
714347|NCT00237666|Secondary|Percentage of Subjects With Clinical Global Inventory (CGI) Global Improvement Score of 1 or 2|"Clinical Global Impression of Improvement scale: one item, measuring overall improvement of illness; possible scores range from 1-7, with lower scores representing greater improvement.
18 subjects (60%) were responders (defined as having a CGI-I scores of 1 or 2 at Week 8/study endpoint) by the end of the trial."|Week 8|||percentage of subjects with CGI-I </=2||95% Confidence Interval|Number
714348|NCT00237666|Secondary|Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale|Montgomery–Åsberg Depression Rating Scale, measuring depression symptoms; possible total scores ranging from 0-60, with higher scores indicating greater severity of depression.|Week 8|Per protocol, the number of participants for analysis was 30 randomized subjects; data analyzed at Week 8 or Last Observation Carried Forward for the 6 subjects who dropped out before completion.||Scores on a scale||Standard Deviation|Mean
714349|NCT00237666|Secondary|Mean Change From Baseline in the Hamilton Anxiety Scale (HAM-A)|Hamilton Anxiety Rating Scale, measuring anxiety symptoms; possible total scores ranging from 0-30, with higher scores indicating greater severity of anxiety.|Week 8|Per protocol, the number of participants for analysis was 30 randomized subjects; data analyzed at Week 8 or Last Observation Carried Forward for the 6 subjects who dropped out before completion.||Scores on a scale||Standard Deviation|Mean
714350|NCT00237666|Primary|The Primary Efficacy Endpoint is the Comparison of Baseline and Week 8 Endpoint in the 17-item HAM-D Total Scores|Hamilton Depression Rating Scale, measuring depression symptoms; possible total scores ranging from 0-54, with higher scores indicating greater severity of symptoms.|Week 8|Per protocol, the number of participants for analysis was 30 randomized subjects; data analyzed at Week 8 or Last Observation Carried Forward for the 6 subjects who dropped out before completion.||Scores on a scale||Standard Deviation|Mean
714351|NCT00237692|Primary|Blood Pressure Averages Systolic & Diastolic|"Blood pressure measured at 12 month.
BP control estimates are marginalized probabilities with corresponding 95% confidence intervals derived from a logistic mixed effects regression model."|12-month|||mmHg||Standard Deviation|Mean
714352|NCT00237692|Primary|Blood Pressure Averages Systolic & Diastolic|"Blood pressure measured at Baseline.
BP control estimates are marginalized probabilities with corresponding 95% confidence intervals derived from a logistic mixed effects regression model."|Baseline|||mmHg||Standard Deviation|Mean
714353|NCT00237692|Primary|Estimated Percentage of Participants in Blood Pressure Control at 18 Months|When patients had multiple blood pressure readings during their 18 month visit, means of their systolic and diastolic readings were used as the 18 month blood pressure values; Using Joint National Committee 7 Report (JNC7) blood pressure guidelines for BP control: <140/90mmHg for non-diabetic patients and < 130/80mmHg for diabetic patients|18 month|||% of particpants with controlled SBP|||Number
714354|NCT00237692|Primary|Estimated Percentage of Participants in Blood Pressure Control at 12 Months|When patients had multiple blood pressure readings during their 12 month visit, means of their systolic and diastolic readings were used as the 12 month blood pressure values; Using Joint National Committee 7 Report (JNC7) blood pressure guidelines for BP control: <140/90mmHg for non-diabetic patients and < 130/80mmHg for diabetic patients|12 month|||% of particpants with controlled SBP|||Number
714355|NCT00237692|Primary|Estimated Percentage of Participants in Blood Pressure Control at 6 Months|When patients had multiple blood pressure readings during their 6 month visit, means of their systolic and diastolic readings were used as the 6 month blood pressure values; Using Joint National Committee 7 Report (JNC7) blood pressure guidelines for BP control: <140/90mmHg for non-diabetic patients and < 130/80mmHg for diabetic patients|6month|||% of particpants with controlled SBP|||Number
714356|NCT00237692|Primary|Estimated Percentage of Participants in Blood Pressure Control at Baseline|When patients had multiple blood pressure readings during their baseline visit, means of their systolic and diastolic readings were used as the baseline blood pressure values; Using Joint National Committee 7 Report (JNC7) blood pressure guidelines for BP control: <140/90mmHg for non-diabetic patients and < 130/80mmHg for diabetic patients|Baseline|||% of particpants w/ controlled BP|||Number
714357|NCT00237718|Secondary|Interleukin-6 (IL-6)|IL-6 is a sensitive laboratory assay for serum levels of interleukin-6, which is a pro-inflammatory cytokine used to evaluate the inflammatory response.|month 6|The number of participants for analysis was based on those subjects who completed the 6-month study. Note that 8 subjects were excluded due to samples being lost. The analysis was per protocol.||pg/ml||Standard Deviation|Mean
714358|NCT00237718|Primary|F2-isoprostane (F2-iso)|F2-iso is a sensitive laboratory assay for serum levels of F2-isoprostane, which is a biomarker of oxidative stress.|month 6|The number of participants for analysis was based on those subjects who completed the 6-month study. Note that 8 subjects were excluded due to samples being lost. The analysis was per protocol.||ng/ml||Standard Deviation|Mean
714359|NCT00237744|Primary|M1 Activation Absolute Change Score|A measure of brain activation change in the area of M1 following intervention (pre to post intervention). A number greater than 0 indicates a change in brain activation in the area of M1. The maximum voxel activation for a healthy adult in the studied region of Interest (M1) is 659.|at baseline and following 3 months of treatment|This is a sub sample of subjects eligible to undergo fMRI testing. A total of 23 subjects were eligible (5 subjects in the wrist/hand FES+ whole arm motor learning group; 8 subjects in the shoulder/elbow robotics+whole arm motor learning group and 10 subjects in the Whole arm motor learning group).||voxels||Standard Deviation|Mean
714360|NCT00237744|Primary|AMAT|The AMAT is a measure of complex functional task performance of a variety of specified tasks and is measured in seconds summed across the various tasks. A higher score is indicative of decreased performance on the measure. A max score of 3000 seconds would indicate inability to perform any portion of the test.|prior to treatment and following 3 months of treatment|||seconds||Standard Deviation|Mean
714361|NCT00237770|Primary|Systolic Blood Pressure During Head-up Tilt|Average systolic blood pressure over 45 minutes at 45 degrees of head-up tilt.|Average systolic blood pressure during head-up tilt (45 degrees) comparing active drug (L-NAME: 1.0 and 2.0 mg/kg) to placebo.|||mmHg||Standard Deviation|Mean
714362|NCT00237796|Secondary|Beck Anxiety Inventory (BAI)|The Beck Anxiety Inventory is a self-report measure of anxiety that consists of 21 questions. Scores from individual items are summed to yield a total score. The total score ranges from 0-63. Higher scores represent greater severity of anxiety.|baseline, mid-treatment, end of treatment, mid follow-up, and follow up|||units on a scale||Standard Deviation|Mean
714363|NCT00237796|Secondary|Beck Depression Inventory-II (BDI-II)|The BDI-II is a self-report measure of depression that consists of 21 questions. The total scale ranges from 0-63. Scores from individual questions are summed to yield a total score. Higher scores represent greater severity of depression.|baseline, mid-treatment, end of treatment, mid follow-up, and follow-up|||units on a scale||Standard Deviation|Mean
714364|NCT00237796|Secondary|The Scale for the Assessment of Negative Symptoms (SANS) - Diminished Motivation|The SANS is a 25 item semi-structured clinical interview designed to assess negative symptoms. There are 9 items that measure diminished motivation which consists of two domains: Avolition-Apathy and Anhedonia-Asociality. Each item is rated from 0 (Absent) to 5 (Severe). The total score is derived from the average of the Affective Flattening and Alogia global ratings (items #17 and #22).|baseline, mid-treatment, end of treatment, mid follow-up, and follow-up|||units on a scale||Standard Deviation|Mean
714365|NCT00237796|Secondary|Scale for the Assessment of Negative Symptoms (SANS) - Diminished Expression|The SANS is a 25 item semi-structured clinical interview designed to assess negative symptoms. The first 13 items measure diminished expression which consists of two domains: Affective flattening and Alogia. Each item is rated from 0 (Absent) to 5 (Severe). The total score is derived from the average of the Affective Flattening and Alogia global ratings (items #8 and #13).|baseline, mid treatment, end of treatment, mid follow-up, and follow up|||units on a scale||Standard Deviation|Mean
714366|NCT00237796|Secondary|Positive and Negative Syndrome Scale (PANSS) - Positive Subscale|The PANSS is 30 item semi-structured clinical interview designed to assess positive and negative symptoms. Positive symptoms are rated on 7 domains: Delusions, Conceptual Disorganization, Hallucinatory Behavior, Excitement, Grandiosity, Suspiciousness/Persecution, and Hostility. Each domain in the positive symptom subscale is rated from 0 (absence of symptom) to 7 (extreme symptom severity). Total scores of the seven domains are summed to yield a total score range of 0 (Absence) to 49 (Extreme), where higher scores represent more severe positive symptoms.|baseline, mid-treatment, end of treatment, mid follow-up, and followup|||units on a scale||Standard Deviation|Mean
714367|NCT00237796|Secondary|Comprehensive Module Test (CMT)|The Comprehensive Module Test (CMT) is an assessment of CBSST skills acquisition in three domains: Communication Skills Test, Problem Solving Test, and Thought Challenging Test. The total CMT score ranges from 0-33. Higher total scores represent higher level of CBSST skills acquisition.|baseline, mid-treatment, end of treatment, mid-follow up, and follow up|||units on a scale||Standard Deviation|Mean
714368|NCT00237796|Primary|Independent Living Skills Survey (ILSS)|The ILSS is a self-report measure in an interview format to assess everyday functioning in ten domains: Appearance and Clothing, Personal Hygiene, Care of Personal Possessions, Food Preparation/Storage, Health Maintenance, Money Management, Transportation, Leisure, Job Seeking, and Job Maintenance. Scale ranges from 0 to 1. Subscales are averaged to yield composite score. Higher scores represent higher level of functioning.|baseline, mid-treatment, end of treatment, mid-follow up, and follow up|||units on a scale||Standard Deviation|Mean
714369|NCT00237809|Secondary|UCSD Performance-Based Skills Assessment (UPSA)|The UCSD Performance-Based Skills Assessment (UPSA) is a role-play test designed to evaluate a person’s functional capacity in two selected areas of basic living skills. These areas include Finance and Communication. Subjects being tested utilize props to demonstrate how they perform everyday activities and are assessed on their actual performance. The higher the score, the better the performance of an individual. The scores range from 0 to 100.|12 weeks|||units on a scale||Standard Deviation|Mean
714370|NCT00237809|Secondary|Simpson-Angus Neurological Rating Scale|Simpson-Angus Scale (SAS) is a 10-item rating scale that has been used widely for assessment in both clinical practice and research settings. Items are rated for severity on a 0-4 scale, with definitions given for each anchor point. The highest possible score is 40.|12 weeks|||units on a scale||Standard Deviation|Mean
714371|NCT00237809|Secondary|Heinrichs-Carpenter Quality of Life Scale|The Heinrichs–Carpenter Quality of Life Scale is a testing device. It has a range of possible scores, 0–126 used to evaluate social functioning & behavior in patients with schizophrenia–lower scores represent poorer mental health.|12 weeks|||units on a scale||Standard Deviation|Mean
714372|NCT00237809|Primary|Positive and Negative Syndrome Scale (PANSS)|The PANSS is a handscored instrument. It uses 25 PANSS items organized into five scales: Negative, Positive, Dysphoric Mood, Activation, and Autistic Preoccupation. The PANSS is based on findings that schizophrenia comprises at least two distinct syndromes. The positive syndrome consists of productive symptoms, while the negative syndrome consists of deficit features. This distinction is useful when developing treatment plans because you can focus on the type of symptoms the patient is experiencing. It is also useful when studying the effects of medication (e.g., in clinical drug trials) because it allows you to determine which type of symptoms are being affected. PANSS Total score minimum = 30, maximum = 210. The greater the score, the greater the symptoms.|12 weeks|||units on a scale||Standard Deviation|Mean
714373|NCT00237809|Primary|Spatial Span- Total Score|The Spatial Span subtest of the Wechsler Memory Scale can be used as an indicator of working memory and visuospatial processing. An increase in severity of impairment results in a decrease in Spatial Span Total Score. The range is 1 to 28.|12 weeks|||units on a scale||Standard Deviation|Mean
714374|NCT00237809|Primary|Hopkins Verbal Learning Test|The Hopkins Verbal Learning Test is designed to assess verbal learning and memory (immediate recall, delayed recall, delayed recognition). The assessment takes approximately 5-10 minutes with a 25-minute delay to complete and 2 minutes to score. The greater the score, the greater the measured recall. The score ranges from 0 to 24.|12 weeks|||units on a scale||Standard Deviation|Mean
714375|NCT00237809|Primary|Wisconsin Card Sorting Test (WCST)|"The WCST allows the clinician to speculate to the following frontal lobe functions: strategic planning, organized searching, utilizing environmental feedback to shift cognitive sets, directing behavior toward achieving a goal, and modulating impulsive responding. The test can be administered to those from 6.5 years to 89 years of age.The test takes approximately 12–20 minutes to carry out and generates a number of psychometric scores, including numbers, percentages, and percentiles of: categories achieved, trials, errors, and perseverative errors. Can be interpreted as: the greater the percentage, the greater the measured ability."|12 weeks|||percentage of correct responses||Standard Deviation|Mean
714376|NCT00238108|Secondary|Change in Blood Pressure||measured before, during, and after each inpatient phase||||||
714377|NCT00238108|Primary|Sleep Quality|Sleep efficiency as measured by polysomnography (total time asleep as a percentage of the 8-hour sleep opportunity)|Measurement after 3 weeks of supplementation|One subject was removed from analysis because of an unstable dose of prescription medication.||% (% asleep during 8 hour opportunity)||Standard Error|Mean
714378|NCT00238121|Secondary|Duration of Response|Duration of response was measured from the time measurement criteria are met for CR(complete response)/PR(partial response), whichever was first recorded, until the first date that PD(progressive disease) was objectively documented. According to the RECIST: Complete Response(CR), disappearance of all target lesions; Partial Response(PR), at least a 30% decrease in the sum of the longest diameter of target lesions; progressive disease(PD), at least a 20% increase in the sum of the longest diameter of target lesions.|Up to 5 years|||Month||Full Range|Mean
714379|NCT00238121|Secondary|Progression Free Survival|Defined as the time from the first day of treatment until the date PD(progressive disease) or death is first reported. Patients who died without a reported prior progression was considered to have progressed on the day of their death. Patients who did not progress was censored at the day of their last tumor assessment. According to RECIST, progressive disease(PD) is defined as at least a 20% increase in the sum of the longest diameter of target lesions.|Up to 5 years|||Month||95% Confidence Interval|Median
714380|NCT00238121|Secondary|Overall Survival|Defined as the time from the first day of therapy to the date of death. If the patient was lost to follow-up, survival was censored on the last date the patient was known to be alive.|Up to 5 years|||Month||95% Confidence Interval|Median
714381|NCT00238121|Primary|Objective Overall Response Rate|Response was defined using the Response Evaluation Criteria in Solid Tumors (RECIST, http://www.ncbi.nlm.nih.gov/pubmed/10655437#): Complete Response(CR), disappearance of all target lesions; Partial Response(PR), at least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR)=CR+PR.|Up to 5 years|||participants|||Number
714382|NCT00238238|Primary|Time to Progression|Time to progression (TTP) is defined as the time from study entry until progression or death without progression. The median TTP with 95% CI was estimated using the Kaplan-Meier method.|Up to 10 years|Three participants assigned to the lenalidomide arm alone arm never began treatment, and the rituximab arm was discontinued early.||years||95% Confidence Interval|Median
714425|NCT00239356|Secondary|Mean Exposure to Aripiprazole at Days 541 to 630, Days 721 to 810 and Days 1081 to 1170 - Safety Population|Mean exposure is mean number of milligrams per day (mg/day) of aripiprazole administered to the participants.|Day 1 to Day 1170|N=number of participants receiving drug at Days indicated.||mg/day||Full Range|Mean
714383|NCT00238238|Primary|Overall Response Rate|Response is assessed by investigator according to International Working Group (IWG) criteria. A complete response requires disappearance of all evidence of disease. A partial response is a >/= 50% decrease in the sum of products of 6 largest dominant nodes or nodal masses as well as for splenic and hepatic nodules. No increase in size of nodes, liver or spleen and no new sites of disease.|Duration of treatment (12 cycles)|Three participants assigned to the lenalidomide arm alone arm never began treatment, and the rituximab arm was discontinued early.||percentage of participants||95% Confidence Interval|Number
714384|NCT00238264|Secondary|Correlation MIB-1 Labeling Index With PFS|The primary methods of analysis will be via stratified Cox regression|Up to 10 years|All eligible patients with MIB-1 data available were included in this analysis. Per protocol, patients were stratified by age and tumor location. Based on a predefined cutoff, patients were categorized as MIB high or low (high: >= 2; low: < 2). The hazard ratio below is for patients with MIB high (low is the reference level).||Hazard ratio||95% Confidence Interval|Number
714385|NCT00238264|Secondary|MIB-1 Labeling Index Using Immunohistochemical Techniques With the MIB-1 Antibody According to Established Methods|The MIB-1 labeling Index will be calculated as the percentage of tumor nuclei that are immunoreactive.|At baseline|All eligible patients with MIB-1 labeling index available.||percentage of tumor nuclei||95% Confidence Interval|Number
714386|NCT00238264|Secondary|Quality of Life (QOL)|QOL accessed using the Behavior Assessment System for Children (BASC), the Adaptive Behavior Assessment System (ABAS), the Behavior Rating Inventory of Executive Function (BRIEF), and the Symptom Checklist-90-R (SCL-90-R).|Up to 5 years|The QOL assessments were removed from the protocol as part of Amendment #1A (as of 10/27/2010) due to extremely low compliance. No QOL data were available for statistical analysis.|||||
714387|NCT00238264|Secondary|Overall Survival Probability|To estimate the overall survival rate for patients with recurrent, progressive or symptomatic low-grade gliomas after treatment with reduced field conformal radiation.|3 years|All eligible patients were included in the analysis, per protocol.||Percentage 3-year OS rate||95% Confidence Interval|Number
714388|NCT00238264|Secondary|Event-free Survival Probability|To estimate the event-free survival rate for patients with recurrent, progressive or symptomatic low-grade gliomas after treatment with reduced field conformal radiation|3 years|All eligible patients were included in the analysis, per protocol.||Percentage 3-year EFS rate||95% Confidence Interval|Number
714389|NCT00238264|Secondary|Progression-free Survival Probability|To estimate the progression-free survival rate for patients with recurrent, progressive or symptomatic low-grade gliomas after treatment with reduced field conformal radiation.|3 years|All eligible patients were included in the analysis, per protocol.||Percentage 3-year PFS rate||95% Confidence Interval|Number
714390|NCT00238264|Primary|Marginal-failure Rate|Patients who do not recur as well as those with either central or distant recurrence would be treatment successes for this endpoint. Monitoring will be based on a Bayesian rule, with binomial likelihood and a Beta on the parameter p, the proportion of failures that are marginal failures.|Up to 5 years|All evaluable patients were included in this analysis (n = 84). One eligible patient was deemed to be not evaluable due to progression during treatment, and was excluded from the analysis per protocol.||percentage of failure rate|||Number
714391|NCT00238303|Secondary|Time to Progression|"Estimated using Kaplan-Meier survival curve.
Definition of progression:
Bidimensionally measurable disease: >25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions.
Evaluable disease (i.e., contrast enhancing mass on MRI and/or CT that is not bidimensionally measurable but clearly evaluable for response to therapy): unequivocal increase in size of contrast enhancement or increase in mass effect as agreed upon independently by primary physician and quality control physicians: appearance of new lesions."|From registration to disease progression (up to 5 years)|Stratum 1: 68 patients were enrolled. 2 stratum 1 patients did not receive treatment. Therefore, the remaining 66 patients were analyzed. The patient that survived 28 months was progression-free at last follow-up.||months||Full Range|Median
714392|NCT00238303|Secondary|Confirmed Tumor Response|"A confirmed tumor response will be defined as an objective status of complete response (CR), partial response (PR), or regression (REGR) on two consecutive evaluations, which include neuroimaging, lasting during a period of at least 6 weeks. Confidence intervals for the true proportion will be calculated using the exact binomial method.
Bidimensionally measurable disease:≥50% reduction in product of perpendicular diameters of contrast enhancement or mass with no new lesions with the patient being on stable or decreased steroid dose.
Evaluable disease (i.e., contrast enhancing mass on MRI and/or CT that is not bidimensionally measurable but clearly evaluable for response to therapy): unequivocal reduction in size of contrast-enhancement or decrease in mass effect as agreed upon independently by primary physician and quality control physicians; no new lesions. Patient should be on stable or decreased steroid dose."|Assessed up to 5 years|"Stratum 1: 68 patients were enrolled. 2 patients did not receive treatment. Therefore, the remaining 66 patients were analyzed.
Stratum 2: Since the patients underwent surgery, response is not applicable and hence 0 patients analyzed."||percentage of participants||95% Confidence Interval|Number
714393|NCT00238303|Secondary|Survival|Estimated using Kaplan-Meier survival curve.|From study registration to date of death due to any cause or last follow-up (up to 5 years)|Stratum 1: 68 patients were enrolled. 2 patients did not receive treatment. Therefore, the remaining 66 patients were analyzed. The patient that survived 28 months was alive at last follow-up.||months||Full Range|Median
714394|NCT00238303|Primary|Proportion of Successes (Patients Alive and Progression-free)|"Estimated using the Binomial point estimator (number of successes divided by the total number of evaluable patients) and the Binomial 95% confidence interval estimated by the exact method.
Definition of progression:
Bidimensionally measurable disease: >25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions.
Evaluable disease (i.e., contrast enhancing mass on MRI and/or CT that is not bidimensionally measurable but clearly evaluable for response to therapy): unequivocal increase in size of contrast enhancement or increase in mass effect as agreed upon independently by primary physician and quality control physicians: appearance of new lesions."|At 6 months|68 Stratum 1 patients were enrolled. 2 stratum 1 patients did not receive treatment. Therefore, the remaining 66 patients were analyzed.||percentage of participants||95% Confidence Interval|Number
714395|NCT00238355|Secondary|Safety||duration of study||||||
714396|NCT00238355|Secondary|Duration of Survival up to 12 Weeks||up to 12 weeks||||||
714444|NCT00239733|Primary|Absolute Change in Platelet Count From Baseline||Through Week 12|||Participants|||Count of Participants
714397|NCT00238355|Primary|Number of Participants With a Complete or Partial Response Rate to the Combination of Voriconazole and Caspofungin at 12 Weeks.|Patients will be followed through day 84 (12 weeks), regardless of continuation of study drugs. Complete response: Resolution of all clinical signs and symptoms and more than 90 percent of the lesions due to invasive fungus that were visible by radiology. Partial response: Clinical improvement and greater than 50 percent improvement in the lesions due to invasive fungus that were visible by radiology.|12 weeks after starting treatment|||Participants|||Number
714398|NCT00238420|Secondary|Five-year Overall Survival|Calculated using the Kaplan-Meier method.|From the date of treatment started to the date of the failure event, assessed up to at least 5 years||||||
714399|NCT00238420|Secondary|Five-year Disease-free Survival|Calculated using the Kaplan-Meier method.|From the date of treatment started to the date of documentation of progression or until the date of death, assessed up to at least 5 years||||||
714400|NCT00238420|Secondary|Complete Response to Treatment|The number of patients within each group who achieved a complete response to protocol treatment by 12 weeks are reported. Complete response is defined as no gross tumor at cystoscopy or negative biopsies or both by week 12 after completion of protocol treatment.|At 12 weeks from treatment start|All eligible patients who started treatment and had an evaluation to assess response by 12 weeks||percentage of participants||95% Confidence Interval|Number
714401|NCT00238420|Secondary|Treatment Completion|The number of patients within each group who completed all elements of protocol treatment are reported.|From registration to end of treatment; up to 64 days.”|All eligible patients who started study treatment||participants|||Number
714402|NCT00238420|Primary|Acute Treatment-related Toxicity|In each group, the number of patients was tabulated by type and grade (gr) of treatment-related toxicity (CTCAE v3.0). Only the following types of toxicity within 90 days of treatment start were considered: ≥ gr4 neutropenia, ≥ gr4 febrile neutropenia, ≥ gr3 diarrhea, ≥ gr3 nausea/vomiting, ≥ gr3 thrombocytopenia, ≥ gr3 renal, pulmonary, hepatic, or neurologic toxicity, ≥ gr3 rectal or genitourinary bleeding, ≥ gr3 left ventricular failure, or ≥ gr2 other cardiac toxicity. The study was designed to estimate the rate of acute treatment-related toxicity separately in each group of patients. Using the Fleming's one-sample multiple test procedure with Type I and II errors each set at 10%, 40 cases/group were required to reject the null hypothesis that the true toxicity rate is greater than 25% in favor of the alternative hypothesis that the true rate is no more than 10%. Six or more patients with the designated toxicities out of 40 would result in rejecting the null hypothesis.|From start of protocol treatment to 90 days|All eligible patients who started study treatment||participants|||Number
714405|NCT00238615|Primary|2 Year Overall Survival After a Combination of Chemotherapy, Radiation and Surgery in Stage III NSCLC Patients Following the Protocol Therapy.|Patients were analyzed for 2 year overall survival after receiving trimodality (chemotherapy/radiation/surgery) therapy for stage III NSCLC. Patients had a chest x-ray and a doctor visit with a physical examination every 3 months after completion of all therapy for 3 years then every 6 months for 3 years to look for evidence of recurrent disease and to follow survival. Thoracic computed tomography (CT) scans were obtained at 6, 12, 18 months after completion of all therapy and then yearly for 3 years or as clinically indicated to evaluate for relapse.|Two years|All patients alive and not censored at 2 years||participants|||Number
714406|NCT00238615|Other Pre-specified|Exploratory Analysis of Relation of Gene Expression Patterns to Outcomes in Patients With Locally Advanced Lung Cancer Who Receive This Treatment Regimen|This analysis of gene expression patterns related to outcomes in patients with locally advanced lung cancer who received this treatment regimen was not performed due to lack of funding.|Specimen collected at time of surgery|Plan was to analyze all patients with adequate tissue for this analysis, but was not done. We did not have sufficient funds for this analysis.|||||
714407|NCT00238615|Secondary|Change in Standard Uptake Value (SUVmax) on Positron Emission Tomography (PET) Scans Pre and Post Chemotherapy and Radiation in This Trial and Ability to Predict Surgical Resection Rate, Progression-free Survival and 2 Year Overall Survival|The change in standardized uptake values (SUV)max on PET scans obtained pre- and after 5 weeks of combined chemo-radiation for patients enrolled on the trial were evaluated for ability to predict outcomes including complete resection at time of surgery (3-6 weeks after completion of the chemo-radiation), progression-free survival and 2 year overall survival. The mean SUVmax pre chemoradiation minus the mean SUVmax post-radiation is reported.|baseline, 5 weeks after combined chemo-radiation|All enrolled patients were analyzed in the published manuscript||standardized uptake value (SUV)max||Standard Deviation|Mean
714408|NCT00239005|Secondary|Changes in Gastrointestinal Symptoms as Measured by the Gastrointestinal Quality of Life Index (GIQLI).|Health-related quality of life (HRQoL)was assessed by the Gastrointestinal Quality of Life Index (GIQLI). The GIQLI is a 36-item questionnaire to assess the impact of GI disease on daily life. The GIQLI also has five different subscales (GI symptoms, emotional status, physical and social functions, and stress of medical treatment) producing a total score of the 36 items. Lower scores represent more dysfunction. A higher score represents a better quality of life (range from 0 to 144).|At week 3 and week 13 (last visit)|Intention to treat (ITT) population consisted of all randomized patients who provided baseline and at least 1 post-baseline assessment of the primary variable. In this analysis patients who completed GIQLI questionnaire in visit 2 (week 1), visit 3 (week 3) and visit 4 (week 13) were included.||Units on a scale||Standard Error|Least Squares Mean
714445|NCT00239733|Primary|Frequency and Severity of Adverse Events||Throughout study, for up to 12 weeks|||Participants|||Count of Participants
714456|NCT00232141|Secondary|Gracely Pain Scale Score|The modified Gracely Pain Scale is a 13-point verbal rating scale based on sensory pain descriptors ranked by severity from nothing (rank = 0) to extremely intense (rank = 15). Subjects selected the verbal descriptors that best matched their average neuropathic pain during the last 24 hours prior to assessment.|Week 14|ITT Population||score on scale||Standard Deviation|Mean
714409|NCT00239005|Secondary|Changes in Gastrointestinal (GI) Symptoms as Measured by the Gastrointestinal Symptom Rating Scale (GSRS).|The GSRS is a 15-item instrument designed to assess the impact of upper and lower GI symptoms. There are five subscales: reflux, diarrhea, constipation, abdominal pain, and indigestion—each of which produces a mean subscale score ranging from 1 (no discomfort) to 7 (very severe discomfort). A higher score represents greater impairment of quality of life due to GI symptoms (range from 1 to 7).|At week 3 and week 13 (last visit)|Intention to treat (ITT) population consisted of all randomized patients who provided baseline and at least 1 post-baseline assessment of the primary variable. In this analysis patients who completed GSRS questionnaire in visit 2 (week 1), visit 3 (week 3) and visit 4 (week 13) were included.||Units on a scale||Standard Error|Least Squares Mean
714410|NCT00239005|Primary|Mycophenolic Acid (MPA) Maintenance Treatment|The primary assessment was based on the percentage of patients who were maintained at week 13 on a dose at least one dose equivalent greater than at baseline (visit 2/week 1). A dose equivalent was defined as EC-MPS 180 mg/day or MMF 250 mg/day.|at week 13 (last visit)|The intent-to-treat (ITT) population consisted of all randomized patients who provided baseline and at least 1 post-baseline assessment of the primary variable.||Percentage of Patients||95% Confidence Interval|Number
714411|NCT00239226|Secondary|Ventricular Pacing Percentage||January 2009||||||
714412|NCT00239226|Secondary|AF Burden||January 2009||||||
714413|NCT00239226|Secondary|Number of Episodes/Day||January 2009||||||
714414|NCT00239226|Secondary|Time to First Persistent Episode of Atrial Fibrillation (AF)||January 2009||||||
714415|NCT00239226|Secondary|Heart Failure: Comparison Between All Groups||January 2009||||||
714416|NCT00239226|Secondary|Number of Cardioversion: Comparison Between All Groups||January 2009||||||
714417|NCT00239226|Secondary|Symptom Scale Questionnaire: Comparison Between All Groups||January 2009||||||
714418|NCT00239226|Secondary|Number of Patients With Permanent Atrial Fibrillation (AF)||January 2009||||||
714419|NCT00239226|Secondary|Number of Persistent Atrial Fibrillation (AF) Episodes: Comparison Between All Groups||January 2009||||||
714420|NCT00239226|Primary|Number of Patients With Persistent Atrial Fibrillation (AF) After a Mean Follow-up of 15±7 Months: Comparison Between IAS and RAA Pacing in the Study Group|Persistent Atrial Fibrillation (AF) incidence|1 year|97 pts completed the study after a mean fu period of 15±7 months.||Number of patients with persistent AF|||Number
714421|NCT00239356|Secondary|Number of Participants With Potentially Clinically Relevant ECG Abnormalities During Treatment - Safety Population|Potentially clinically relevant abnormality or change relative to baseline: sinus tachycardia: >= 120 beats per minute (bpm) and increased >= 15 bpm; sinus bradycardia: <= 50 bpm and decrease >= 15 bpm; supraventricular tachycardia, ventricular tachycardia, atrial fibrillation, atrial flutter: not present to present. First degree atrioventricular (A-V) block: PR interval(beginner of P wave to beginning of complex of Q, R, and S waves) >= 0.20 seconds (sec) and increase >= 0.05 sec; second and third degree A-V block, right bundle branch block (RBB) block, left bundle branch block (LBB) block: not present to present; other intraventricular block: QRS (complex of Q, R and S waves) >= 0.12 sec and increase >= 0.02 sec. Myocardial ischemia not present to present. QT interval with Bazett's correction (QTcB) or Fridericia's correction (QTcF) >= 450 milliseconds (msec) and elevation of 10% over baseline.|Baseline to end of study (Week 348|Safety Population: all participants with at least 1 dose of study drug. Number of participants analyzed is given as N in each ECG parameter and includes those treated participants with ECG measurements.||participants|||Number
714422|NCT00239356|Secondary|Number of Participants With Potentially Clinically Relevant Vital Sign Abnormality During Treatment - Safety Population|Vital signs include standing, sitting and supine systolic and diastolic blood pressure, measured in millimeters of mercury (mmHg) and standing, sitting and supine heart rate, measured in beats per minute. Baseline (BL) is Day 1 of the study, prior to study drug administration. Criteria for identifying vital sign values as clinically relevant: Systolic blood pressure (criterion value=90-180 mmHg) change relative to baseline: increase of greater than, equal to (>=) 20; decrease of >= 20 mmHg. Diastolic blood pressure (criterion value=50 - 105 mmHg) change relative to baseline: increase of >= 15; decrease of >= 15 mmHg. Heart rate (criterion value=50-120bpm) change relative to baseline: increase >=15; decreased >= 15 mmHg. To be clinically significantly abnormal: value must meet the criterion value and also represent a change from the participant's pre-treatment value of at least the magnitude shown in the change relative to baseline.|Baseline to end of study (Week 348)|Safety Population: all participants with at least 1 dose of study drug. Number of participants analyzed is given as N in each vital sign parameter and includes those treated participants with vital sign measurements.||participants|||Number
714423|NCT00239356|Secondary|Number of Participants With Potentially Clinically Relevant Hematology Laboratory Abnormalities During Treatment - Safety Population|Clinically relevant laboratory abnormality: Hemoglobin male <= 11.5 g/dL; female <= 9.5 g/dL. Hematocrit male <= 37 and 3 point decrease from baseline (BL); female <=32 and 3 point decrease from BL. Leukocytes <= 2800 mm^3 or >= 16000 mm^3; eosinophils >=10%. Baseline is Day 1 of the study, prior to study drug administration.|Baseline to end of study (Week 348)|Safety Population: all participants with at least 1 dose of study drug. Number of participant analyzed is given as N in each category of laboratory test.||participants|||Number
714424|NCT00239356|Secondary|Number of Participants With Potentially Clinically Relevant Chemistry Laboratory Abnormalities During Treatment - Safety Population|Clinically relevant abnormalities: greater than, equal to (>=); less than, equal to (<=). Upper limits of normal (ULN). milligram per deciliter (mg/dL); milliequivalent per liter (mEq/L); nanograms per milliliter (ng/mL);outside of normal range inclusive (): alanine transaminase (ALT>= 3*ULN; aspartate aminotransferase (AST >=3*ULN; alkaline phosphatase >=3*ULN; total bilirubin >= 2.0 mg/dL; blood urea nitrogen >= 30mg/dL; calcium (8.40 - 9.90 mg/dL); chloride (85.00 - 108.00 mEq/L); total cholesterol (140.0 - 200.0 mg/dL); cholesterol high density (HDL) and low density (LDL) lipoprotein (39.0 - 116.0 mg/dL); creatine kinase (15.0 - 170.0 U/L); creatinine >=2.0 mg/dL; prolactin (3.00 - 29.00 ng/mL); sodium (136.0 - 144.0 mEq/L); Glucose fasting (70.0 - 110.0 mg/dL); triglycerides (58.0 - 164.0 mg/dL; uric acid male >= 10.5, female >= 8.5mg/dL. Baseline is Day 1 of the study, prior to study drug administration.|Baseline to end of study (Week 348)|Safety Population: all participants with at least 1 dose of study drug. Number of participant analyzed is given as N in each category of laboratory test.||participants|||Number
714426|NCT00239356|Secondary|Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs), and Discontinuation Due to an AE - Safety Population|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug.|Baseline to Week 348|Safety Population: all participants with at least 1 dose of study drug.||participants|||Number
714427|NCT00239356|Primary|Mean Clinical Global Impression Severity Score (CGI-S) From Baseline Through End of Study- - Safety Population.|Baseline is Day 1 of the study, prior to first dose. CGI-S is a questionnaire completed by the clinician which evaluates the severity of mental illness of a participant at a specific point in time. It consists of 7 categories with the lower categories indicating less illness and the higher numbered categories indicating greater severity of illness: 0=not assessed; 1=normal, not at all ill; 2=borderline mentally ill; 3= mildly ill; 4=moderately ill; 5= markedly ill; 6=severely ill; 7=among the most extremely ill.|Baseline to Week 348|Safety Population - all participants who received at least one dose of drug. N=number of participants who were analyzed at each specific time point. Baseline N=97, 20 for first and second arms, respectively.||units on a scale||Standard Deviation|Mean
714428|NCT00239642|Secondary|Percentage (%) of Subjects With Stable EPO Dosing or a Decrease >25% in EPO Dose From Baseline|Summary of the Percentage (%) of Subjects with Stable EPO Dosing or a Decrease >25% in EPO Dose from Baseline|anytime during the 12 week post-baseline period|mITT subjects||percentage of subjects|||Number
714429|NCT00239642|Secondary|Proportion of Subjects With Stable Erythropoietin (EPO) Dosing or a Decrease >25% in EPO Dose From Baseline|Summary of the Proportion of Subjects with Stable erythropoietin (EPO) Dosing or a Decrease >25% in EPO dose from Baseline|anytime during the 12 week post-baseline period|mITT subjects||participants|||Number
714430|NCT00239642|Secondary|Percentage (%) of Subjects With TSAT Between 20% and 50%, Inclusive|Summary of the Percentage (%) of Subjects with TSAT between 20% and 50%, Inclusive|anytime during the 12 week post-baseline period|mITT subjects||percentage of subjects|||Number
714431|NCT00239642|Secondary|Proportion of Subjects With Transferrin Saturation (TSAT) Between 20% and 50%, Inclusive|Summary of the Proportion of Subjects with transferrin saturation (TSAT) between 20% and 50%, Inclusive|anytime during the 12 week post-baseline period|mITT subjects||participants|||Number
714432|NCT00239642|Secondary|Percentage (%) of Subjects With Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive|Summary of the Percentage (%) of Subjects with Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive|anytime during the 12 week post-baseline period|mITT subjects||percentage of subjects|||Number
714433|NCT00239642|Secondary|Number of Subjects With Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive|Summary of the Number of Subjects with Hemoglobin between 10.5 g/dL and 14.0 g/dL, Inclusive|anytime during the 12-week post-baseline period|mITT subjects||participants|||Number
714434|NCT00239642|Secondary|Percentage (%) of Subjects Achieving Clinical Success|Summary of the Percentage (%) of Subjects Achieving Clinical Success During the 12-Week Study Period - Hemoglobin between 10.5 g/dL and 14.0 g/dL, Inclusive, TSAT between 20% and 50%, Inclusive, and stable EPO Dosing (±25% of Baseline Dose)|anytime during the 12 week post-baseline period|mITT subjects||percentage of subjects|||Number
714435|NCT00239642|Secondary|Number of Subjects Achieving Clinical Success|Summary of the Number of Subjects Achieving Clinical Success During the 12-Week Study Period - Hemoglobin between 10.5 g/dL and 14.0 g/dL, Inclusive, TSAT between 20% and 50%, Inclusive, and Stable EPO Dosing (±25% of Baseline Dose)|anytime during the 12 week post-baseline period|mITT subjects||participants|||Number
714436|NCT00239642|Primary|Safety Profile: Number of Subjects Experiencing at Least 1 Adverse Event|Safety Profile: Number of subjects who experienced at least 1 adverse event in each arm|baseline through week 12|Safety Population - Subjects who received at least 1 dose of study drug.||participants|||Number
714437|NCT00239681|Secondary|Time to Bone Fracture|Days from randomization until bone fracture. If no event, then censoring occurs at earliest of termination date or efficacy cutoff date of 30 Mar 2008. Kaplan-Meier estimate of the mean|Up to 5 years|Intention to treat population||Days||Standard Error|Mean
714438|NCT00239681|Secondary|Time to Venous Thromboembolic Event|Time from randomization to the first venous thromboembolic event. Kaplan-Meier estimate of the mean|up to 5 years|Intention to treat population||Days||Standard Error|Mean
714439|NCT00239681|Secondary|Time to Development of Diabetes Mellitus|Days from randomization until development of diabetes. If no diabetes was developed censoring occurred at termination date. Kaplan-Meier estimate of the mean|up to 5 years|Intention to treat population||Days||Standard Error|Mean
714440|NCT00239681|Secondary|Time to Non-cardiovascular Death|Days from randomization to death from a non-cardiovascular cause. If no event, then censoring occurs at earliest of termination date or efficacy cutoff date of 30 Mar 2008. Events were adjudicated by an endpoint committee. Kaplan-Meier estimate of the mean|up to 5 years|Intention to treat population||Days||Standard Error|Mean
714441|NCT00239681|Secondary|Time to Death Due to Any Cause|Days from randomization to death. If no death then censoring occurs at earliest of termination date or efficacy cutoff date of 30 Mar 2008. Kaplan-Meier estimate of the mean|up to 5 years|Intention to treat population||days||Standard Error|Mean
714442|NCT00239681|Primary|Time to Major Cardiac Event (Cardiovascular Death, Stroke, Myocardial Infarction, Hospitalization Due to Unstable Angina or Arterial Revascularization)|Days from randomization to the first of CV death, stroke, MI, hospitalization for unstable angina or arterial revascularization. If no event, censoring occurs at earliest of termination date or efficacy cut-off date of 30 Mar 2008. Events were adjudicated by an endpoint committee. Kaplan-Meier estimate of the mean|up to 5 years|Intention to treat population||Days||Standard Error|Mean
714443|NCT00239720|Primary|Proportion of Participants Who Received at Least Two Cycles of Treatment and Who Showed Predefined Levels of Improvement in Primary Efficacy Parameter at Six Months|"Participants who improve by at least 1 unit from baseline in either the physician or participant global assessment and have at least 30% improvement from baseline in either tender or swollen joint scores[1] at 6 months from start of treatment and received at least 2 cycles of treatment
The tender and swollen joint scores assess 68 and 66 joints, respectively, with each joint rated from 0 to 3. Total scores range from 0-204 for tenderness and 0-198 for swelling, with higher scores indicating more severe symptoms[2].
Ref: Clegg DO et al. Arthritis Rheum. 1996; 39(12):2013-20."|6 Months|Intent-to-treat|||||
714446|NCT00239837|Secondary|Decision Making|“Cups” task (Weller et al., 2007). On each trial, participants see 2 arrays with equal number of X cups (2, 3, or 5) each. On gain trials, participants informed that under each cup in one array is 1 quarter, and the other array includes 1 cup with Y quarters (either 2, 3, or 5), but the other cups have 0 quarters. Choosing from the riskless side leads to a sure gain of 1 quarter while choosing the risky side can lead to gain of Y quarters or no quarters. On loss trials, participants shown that choosing cup from 1 array will lead to 1 quarter taken away while choosing cup from other array will lead to no quarters or Y quarters taken. Cups task consists of 54 trials of 3 trials each of all combinations of 2 levels of domain (gain, loss). Expected Value Sensitivity (EV) calculated by subtracting proportion of risky choices made when EV actually favored the sure choice from proportion of risky choices made on trials where EV favored risky option. Score can range from -1.0 to -1.0.|Measured at age 15-17|||units on a scale||Standard Deviation|Mean
714447|NCT00239837|Primary|Marijuana Use|The girls were asked how many times in the past year they had used marijuana. The response scale ranged from 1 (never) through 9 (daily). Units on a scale. Log transformed.|Measured at Month 36|Full information maximum likelihood (FIML) analysis includes estimation of all cases even when missing data are present||log(units on a scale)||Standard Deviation|Mean
714448|NCT00239837|Primary|Tobacco Use|The girls were asked how many times in the past year they had smoked cigarettes or chewed tobacco. The response scale ranged from 1 (never) through 9 (daily). Units on a scale.|Measured at Month 36|Full information maximum likelihood (FIML) analysis includes estimation of all cases even when missing data are present||log(units on a scale)||Standard Deviation|Mean
714449|NCT00239837|Secondary|Placement Changes|Child welfare system records were collected at each assessment to determine the girls’ placement changes (including the number and type of changes). Placement changes since the start of the study through 12 months were summed for each girl. The number of placement changes ranged from 0 to 7 during this period. Units on a scale. Higher scores indicate more placement changes.|Measured at Months 6 and 12|Full information maximum likelihood (FIML) analysis includes estimation of all cases even when missing data are present||placement changes||Standard Deviation|Mean
714450|NCT00239837|Secondary|Social Competence|Prosocial behavior was measured with a subscale from the Parent Daily Report (PDR; Chamberlain & Reid, 1987). The PDR was administered individually by telephone to foster parents on 3 consecutive or closely spaced days (1–3 days apart) at each assessment. A trained interviewer asked the foster parent whether a list of prosocial behaviors took place during the previous 24 hr (yes/no format). The prosocial scale was computed based on nine items, such as “cleans up after herself” and “do a favor for someone.” The PDR was designed to avoid the potential bias of aggregate recall of frequency estimates. Studies have reported concurrent and predictive validity of the PDR checklist. The scores were averaged (mean) across calls from 3 days. Scores on prosocial behavior at 6 and 12 months were averaged and the mean across both time points was used in analysis. Units on a scale. Range = 0-9. Higher scores indicate more prosocial behavior.|Measured at Months 6, 12|Full information maximum likelihood (FIML) analysis includes estimation of all cases even when missing data are present||units on a scale||Standard Deviation|Mean
714451|NCT00239837|Secondary|Participation in Risky Sexual Behaviors|Eight items from the girls’ in-person interviews were used to assess health risking sexual behavior at the 36-month followup. The girls reported on items such as touching a boy’s body above or below the waist, having sexual intercourse, having sex with someone who they just met, or having sex with someone using drugs in the past 12 months. Positive answers to these items were totaled to represent the cumulative number of health-risking sexual behaviors. The frequency of the cumulative number of risky sexual acts ranged from 0 to 7. Units on a scale. Higher scores indicate more health-risking sexual behaviors.|Measured at Month 36|FIML analysis includes estimation of all cases even when missing data are present||units on a scale||Standard Deviation|Mean
714452|NCT00239837|Secondary|Mental Health Problems|Internalizing and externalizing symptoms at 12 and 24 months were measured with caregiver report on the Achenbach System of Empirically Based Assessment (ASEBA). This widely used checklist for psychopathological behaviors includes scales for behaviors such as Anxious/Depressed; Withdrawn; Somatic Complaints; Thought Problems; Attention Problems; Aggressive Behavior; Rule-Breaking Behavior; and Intrusive. The ASEBA has been shown to have both construct and content validity in the literature. For the present study, raw scores for the internalizing and externalizing symptoms subscales were used. Scores at 12 and 24 months were combined and averaged (mean). Units on a scale. Range = 0-66. Higher scores indicate higher levels of internalizing or externalizing problems.|Measured at Months 12 and 24|Full information maximum likelihood (FIML) analysis includes estimation of all cases even when missing data are present||units on a scale||Standard Deviation|Mean
714453|NCT00239837|Primary|Delinquency|36 items from the general delinquency scale from the Self-Report Delinquency Scale (SRD; Elliott, Huizinga, & Ageton, 1985). Units on a scale. Girls were asked to rate how many times they had committed various delinquent acts (e.g., damaging or destroying properties, and stealing) in the past year, using an open-ended format. The mean of frequencies across these items was used to represent the level of delinquency for girls. The general delinquency scale scores ranged from 0 to 24 (full scale) and from 0 to 13 (log transformed). Higher scores indicate higher levels of delinquency.|Measured at Month 36|FIML analysis includes estimation of all cases even when missing data are present||log(units on a scale)||Standard Deviation|Mean
714454|NCT00232141|Secondary|Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table|Shift from baseline in median sensory thresholds (designated as Weight) from 3 trials as measured on the QANeP. Improved - a decrease in the median of the three trials at endpoint. Worsened - an increase. Note: Sensory Thresholds are the highest values of the three Trials at both baseline (Week=0) and endpoint (Week 14).|Baseline-Week 14 (Endpoint)|ITT Population||participants|||Number
714455|NCT00232141|Secondary|Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table|Shift from baseline in maximum sensory thresholds (in grams representing the force equivalent of various sizes of von Frey filaments) as measured on QANeP. Improved - decrease in the maximum of the 3 trials at endpoint. Worsened - an increase. Note:Sensory Thresholds are the highest values of the 3 trials at baseline (Week=0) and endpoint (Week 14)|Baseline-Week 14 (Endpoint)|ITT Population; Pregabalin weight range- 3.61, 4.31, 4.56, 5.07, 6.65 and not perceived. Placebo weight range- 2.83, 3.61, 4.31, 4.56, 5.07, 6.65 and not perceived||participants|||Number
714986|NCT00247273|Secondary|Percent Change From Baseline in Serum CTX at Month 6, ITT Population|Assayed by electrochemiluminescent immunoassay.|Baseline to Month 6|ITT||Percent Change||95% Confidence Interval|Least Squares Mean
714457|NCT00232141|Secondary|Duration of Spontaneous Pain-NPSI (Neuropathic Pain Symptom Inventory)|Change from baseline to endpoint in the duration of spontaneous pain. The NPSI includes the temporal item for assessment of duration of spontaneous, ongoing and paroxysmal pain. Assessed using a 5-point specific categorical scale and refers to the past 24 hours at endpoint.|Baseline, Week 14|ITT Population||participants|||Number
714458|NCT00232141|Secondary|Change in Number of Pain Attacks Compared to Baseline - NPSI (Neuropathic Pain Symptom Inventory)|Change from baseline in the number of pain attacks at endpoint. The NPSI includes the temporal item for assessing the numbers of pain attacks. Assessed using a 5-point specific categorical scale and refers to the past 24 hours at endpoint.|Baseline, Week 14|ITT Population||participants|||Number
714459|NCT00232141|Secondary|Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks|Number of subjects reporting pain attacks. The NPSI includes the temporal item for assessing the numbers of pain attacks. Assessed using a 5-point specific categorical scale and refers to the past 24 hours at endpoint.|Baseline-Week 14 (Endpoint)|ITT Population||participants|||Number
714460|NCT00232141|Secondary|Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain|Number of subjects reporting duration of spontaneous pain. The NPSI includes the temporal item for assessment of duration of spontaneous, ongoing and paroxysmal pain. Assessed using a 5-point specific categorical scale and refers to the past 24 hours at endpoint.|Baseline-Week 14 (Endpoint)|ITT Population||participants|||Number
714461|NCT00232141|Secondary|Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Enjoyment of Life)|Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.|Baseline, Weeks 1,2,6,10,14 and Endpoint|ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).||score on scale||Standard Error|Least Squares Mean
714462|NCT00232141|Secondary|Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Sleep)|Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.|Baseline, Weeks 1,2,6,10,14 and Endpoint|ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).||score on scale||Standard Error|Least Squares Mean
714463|NCT00232141|Secondary|Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Relations With Other People)|Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.|Baseline, Weeks 1,2,6,10,14 and Endpoint|ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).||score on scale||Standard Error|Least Squares Mean
714464|NCT00232141|Secondary|Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Normal Work Including Both Work Outside the Home and Housework)|Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.|Baseline, Weeks 1,2,6,10,14 and Endpoint|ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).||score on scale||Standard Error|Least Squares Mean
714465|NCT00232141|Secondary|Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Walking Ability)|Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.|Baseline, Weeks 1,2,6,10,14 and Endpoint|ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).||score on scale||Standard Error|Least Squares Mean
714466|NCT00232141|Secondary|Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Mood)|Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.|Baseline, Weeks 1,2,6,10,14 and Endpoint|ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).||score on scale||Standard Error|Least Squares Mean
714467|NCT00232141|Secondary|Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your General Activity)|Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.|Baseline, Weeks 1,2,6,10,14 and Endpoint|ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).||score on scale||Standard Error|Least Squares Mean
714468|NCT00232141|Secondary|Change in Brief Pain Inventory-sf Scores (How Much Pain Are You Having Right Now)|Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.|Baseline, Weeks 1,2,6,10,14 and Endpoint|ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).||score on scale||Standard Error|Least Squares Mean
714566|NCT00233103|Primary|Depression at Baseline|"The 17-item Hamilton Rating Scale for Depression (HAM-D) is a widely used clinician-rated measurement of depression severity. A score of 0-7 is considered to be normal. 8-13 = mild depression, 14-18 = moderate depression, 19-22 = severe depression, and ≥ 23 = very severe depression.
Self-report of depression and DSM-IV diagnosis (HAM-D score) at baseline."|baseline|||units on a scale||Standard Deviation|Mean
714469|NCT00232141|Secondary|Change in Brief Pain Inventory-sf Scores (Average Level of Pain in the Past 24 Hours)|Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.|Baseline, Weeks 1,2,6,10,14 and Endpoint|ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).||score on scale||Standard Error|Least Squares Mean
714470|NCT00232141|Secondary|Change in Brief Pain Inventory-sf Scores (The Least Pain in the Past 24 Hours)|Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.|Baseline, Weeks 1,2,6,10,14, Endpoint-LOCF|ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).||score on scale||Standard Error|Least Squares Mean
714471|NCT00232141|Secondary|Change in Brief Pain Inventory-short Form (BPI-sf) Scores (The Worst Pain in the Past 24 Hours)|Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.|Baseline, Weeks 1,2,6,10,14, Endpoint - LOCF|ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).||score on scale||Standard Error|Least Squares Mean
714472|NCT00232141|Secondary|Shift in Hospital Anxiety and Depression (HADS) Subscales|Anxiety subscale analyzes generalized anxiety (anxious mood,restlessness, anxious thoughts, panic attacks). The depression subscale focuses on the state of lost interest and diminished pleasure response. A score of Normal = 0-7, Mild = 8-10, Moderate = 11-14, Severe = 15-21.|Baseline, Week 14|ITT Population||participants|||Number
714473|NCT00232141|Secondary|Change in NRS-Sleep Interference Scores|Change in mean Pain-related sleep interference was assessed on an 11-point scale from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]). Weekly mean score was the sum of the daily diary scores divided by the number of diary entries during that week.|Baseline, Weeks 1-14|ITT Population; n = number of participants with data for analysis (n=pregabalin, placebo).||score on scale||Standard Error|Least Squares Mean
714474|NCT00232141|Other Pre-specified|Duration Adjusted Average Change From Baseline in NRS Pain Scores|Duration Adjusted Average Change(DAAC) in NRS-Pain score = (mean at observation – mean at baseline)x(proportion of planned study duration that the subject completed).|Weekly: Week 1 - Week 14|ITT Population||score on scale||Standard Error|Least Squares Mean
714475|NCT00232141|Secondary|Change in Quantitative Assessment of Neuropathic Pain (QANeP)|Change in a quantitative assessment of the participants’ neuropathic pain were on an 11-point scale ranging from 0 (no pain) to 10 (most intense pain imaginable).|Baseline, Week 14|ITT Population; n = number of participants with data for analysis (n=pregabalin, placebo).||score on scale||Standard Error|Least Squares Mean
714476|NCT00232141|Secondary|Change in Neuropathic Pain Symptom Inventory (NPSI) Subscores and Total Intensity Scores|Change in mean score NPSI, questionnaire evaluates symptoms of neuropathic pain. 10 pain descriptors questions answered on an 11-point scale 0 (no pain)-10 (most intense pain imaginable). 2 items related to temporal pain assessed on 5-point scales. The NPSI derives 5 pain subscores & a total intensity score calculated from the 5 pain subscores|Baseline, Week 14|ITT Population; n = number of participants with data for analysis (n=pregabalin, placebo).||score on scale||Standard Error|Least Squares Mean
714477|NCT00232141|Secondary|Patient Global Impression of Change (PGIC) Rating|PGIC is a participant-rated instrument that measures change in the participants overall status on a 7-point scale. Scores range from 1 (very much improved) to 7 (very much worse).|Baseline, Week 14, Endpoint-LOCF|ITT Population||participants|||Number
714478|NCT00232141|Secondary|Categorized Patient Global Impression of Change (PGIC)|The PGIC is a participant-rated instrument that measures change in the participants overall status on a 7-point scale. Scores range from 1 (very much improved) to 7 (very much worse). PGIC was evaluated using 3 categories of Improvement (Scores 1-3), No Change (Score 4), and Worsening (Scores 5-7).|Baseline, Week 14|ITT Population||participants|||Number
714479|NCT00232141|Secondary|Change From Baseline for NRS-Sleep Interference Scores|11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain])|Baseline, Week 14|ITT Population||score on scale||Standard Error|Least Squares Mean
714480|NCT00232141|Secondary|Change From Baseline for Modified Brief Pain Inventory-Short Form (mBPI-sf) Scores|Change from baseline to endpoint in the mBPI-sf to assess pain severity and pain interference with functional activities: 11-point scale ranging from “no pain” (0) to “pain as bad as you can imagine” (10)|Baseline, Week 14|ITT Population; n = number of participants with data for analysis reported (n=pregabalin, placebo).||score on scale||Standard Error|Least Squares Mean
714481|NCT00232141|Secondary|Change From Baseline for Hospital Anxiety and Depression Scale (HADS) Subscales|Change from Baseline in scale at endpoint: normal (score 0) to severe (score 21).|Baseline, Week 14|ITT population||score on scale||Standard Error|Least Squares Mean
714482|NCT00232141|Secondary|Change From Baseline for MOS (Medical Outcomes Study)-Sleep Subscales and Sleep Problem Indices|Change from baseline in MOS-Sleep subscales & Sleep Problem Indices. Twelve item subject-rated questionnaire assessing sleep constructs. Scores range from 0 – 100 and higher scores reflect more impairment. Subscales “sleep adequacy”, “quantity of sleep” and “optimal sleep” low scores reflect impairment.|Baseline, Week 14|ITT Population; n = number of participants with data for analysis (n=pregabalin, placebo).||score on scale||Standard Error|Least Squares Mean
714483|NCT00232141|Other Pre-specified|Responders - Decreases of at Least 30% in Mean Weekly Pain Score|Number of subjects that experienced at least 30% decrease in mean weekly pain.|Weeks 1-14 endpoint BOCF|ITT population; n = number of participants with data for analysis reported per week per treatment group (n=pregabalin, placebo); BOCF = modified baseline observation carried forward||participants|||Number
714484|NCT00232141|Other Pre-specified|Responders- Decreases of at Least 50% in Mean Weekly Pain Score|Number of subjects that experienced at least a 50% decrease in mean weekly pain.|Weeks 1-14 Endpoint BOCF (modified baseline observation carried forward)|ITT population; n = number of participants with data for analysis reported per week per treatment group (n=pregabalin, placebo), BOCF = modified baseline observation carried forward||participants|||Number
714485|NCT00232141|Other Pre-specified|Change in NRS-Pain Scores From Baseline to Endpoint-BOCF (Modified Baseline Observation Carried Forward)|Change from baseline in mean NRS-Pain scores at endpoint-BOCF. Daily pain scores were assessed on an 11-point numerical rating scale <(NRS)-Pain> ranging from 0 (no pain) to 10 (worst possible pain). Change from baseline in mean weekly pain scores was analyzed using longitudinal models assuming data were missing at random (MAR)|Baseline, Weeks 1 - 14 and Endpoint-BOCF|ITT population; n = number of participants with data for analysis reported per week per treatment group (n=pregabalin, placebo).||score on scale||Standard Error|Least Squares Mean
714486|NCT00232141|Primary|Change From Baseline for Numerical Rating Scale (NRS) Pain Scores at Endpoint-LOCF (Last Observation Carried Forward) Relative to Baseline|Change from baseline in mean NRS-Pain scores at endpoint-LOCF. Daily pain scores were assessed on an 11-point numerical rating scale <(NRS)-Pain> ranging from 0 (no pain) to 10 (worst possible pain).|Baseline, Week 14|ITT population (ie, full analysis set)=all randomized participants who took at least 1 dose & had at least 1 post-randomization efficacy assessment. The endpoint-LOCF mean value was computed from last 7 diary entries (Day 2 up to and including the day after the last dose w/n Dose-Adjustment or Maintenance phase (up to Day 99).||score on scale||Standard Error|Least Squares Mean
714487|NCT00232180|Secondary|Number of Participants With New Onset Diabetes Mellitus (DM)|The definition of new onset diabetes mellitus is the diagnosis of diabetes mellitus in a participant after randomization, when DM was not present before randomization.|Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)|FAS using ITT principle: Here 'N' (Number of Participants Analyzed) signifies those who did not report a history of diabetes mellitus at baseline and “n” signifies participants evaluated at that time point.||participants|||Number
714488|NCT00232180|Secondary|Number of Participants With New Onset Atrial Fibrillation or Flutter|New onset of atrial fibrillation or flutter is defined as the diagnosis of atrial fibrillation or flutter in a participant after randomization, where atrial fibrillation was not present before randomization.|Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)|FAS using ITT principle: Here 'N' (Number of Participants Analyzed) signifies those who did not report a history of atrial fibrillation at baseline and “n” signifies participants evaluated at that time point.||participants|||Number
714489|NCT00232180|Secondary|Number of Participants With First Occurrence of Hospitalization Due to Hyperkalemia (Adjudicated)|First occurrence of hospitalization due to hyperkalemia. Hospitalization due to hyperkalemia is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to hyperkalemia as the primary reason for hospitalization as determined by endpoint committee adjudicator. Hyperkalemia is defined as serum potassium level greater than (>) 5.5 milliequivalents per liter (mEq/L).|Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)|FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here “n” signifies participants evaluated at that time point.||participants|||Number
714490|NCT00232180|Secondary|Number of Participants With First Occurrence of Hospitalization Due to Worsening Renal Function (Adjudicated)|First occurrence of hospitalization due to worsening renal function. Hospitalization due to worsening renal function is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to worsening renal function as the primary reason for hospitalization as determined by endpoint committee adjudicator. Worsening renal function is defined as doubling of serum creatinine level from baseline level.|Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)|FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here “n” signifies participants evaluated at that time point.||participants|||Number
714491|NCT00232180|Secondary|Number of Participants With First Occurrence of Implantation of Resynchronization Device (Cardiac Resynchronization Therapy [CRT]) (Adjudicated)|First occurrence of implantation of resynchronization device. CRT is use of a specialized pacemaker to re-coordinate the action of the right and left ventricles in heart failure.|Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)|FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here “n” signifies participants evaluated at that time point.||participants|||Number
714492|NCT00232180|Secondary|Number of Participants With First Occurrence of Implantation of Cardiac Defibrillator (ICD) (Adjudicated)|First occurrence of implantation of cardiac defibrillator (ICD). ICD is an electronic device capable of monitoring the heart rhythm. When the heart is beating normally, the device remains inactive. If the heart develops a life-threatening tachycardia, the ICD delivers electrical shocks to the heart to terminate the abnormal rhythm and return the heart rhythm to normal.|Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)|FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here “n” signifies participants evaluated at that time point.||participants|||Number
714493|NCT00232180|Secondary|Number of Participants With First Occurrence of Fatal or Non-fatal Stroke (Adjudicated)||Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)|FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here “n” signifies participants evaluated at that time point.||participants|||Number
714494|NCT00232180|Secondary|Number of Participants With First Occurrence of Fatal or Non-fatal Myocardial Infarction (Adjudicated)||Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)|FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here “n” signifies participants evaluated at that time point.||participants|||Number
714495|NCT00232180|Secondary|Number of Participants With First Occurrence of Cardiovascular (CV) Hospitalization (Adjudicated)|First occurrence of CV hospitalization. CV hospitalization is defined as hospitalization due to HF (first or subsequent), acute myocardial infarction, angina pectoris (unstable), cardiac arrhythmia (atrial fibrillation [AF], atrial flutter, supraventricular arrhythmias, or ventricular arrhythmias), stroke/CVA, other CV reasons (such as hypotension or peripheral vascular disease), implantation of a cardioverter defibrillator (ICD), or cardiac resynchronization therapy (CRT) with CV event as the primary reason for hospitalization as determined by endpoint committee adjudicator.|Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)|FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here “n” signifies participants evaluated at that time point.||participants|||Number
714496|NCT00232180|Secondary|Number of Participants With First Occurrence Of Heart Failure (HF) Mortality or Heart Failure (HF) Hospitalization (Adjudicated)|Death due to HF or first occurrence of HF hospitalization. Hospitalization due to HF is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF as the primary reason for hospitalization as determined by the endpoint committee adjudicator.|Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)|FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here “n” signifies participants evaluated at that time point.||participants|||Number
714497|NCT00232180|Secondary|Number of Participants With First Occurrence of All-Cause Mortality or All-Cause Hospitalization (Adjudicated)|Death due to any cause or hospitalization due to any cause. Hospitalization due to any cause is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility).|Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)|FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here “n” signifies participants evaluated at that time point.||participants|||Number
714498|NCT00232180|Secondary|Number of Participants With First Occurrence of Heart Failure (HF) Hospitalization (Adjudicated)|First occurrence of HF hospitalization. Hospitalization due to HF is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF as the primary reason for hospitalization as determined by the endpoint committee adjudicator.|Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)|FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here “n” signifies participants evaluated at that time point.||participants|||Number
714499|NCT00232180|Secondary|Number of Participants With First Occurrence of All-Cause Hospitalization (Adjudicated)|Hospitalization due to any cause is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility).|Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)|FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here “n” signifies participants evaluated at that time point.||participants|||Number
714500|NCT00232180|Secondary|Number of Participants With First Occurrence of Cardiovascular (CV) Mortality (Adjudicated)|CV mortality is defined as death due to heart failure, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident (CVA), other CV cause (such as aneurysm or pulmonary embolism).|Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)|FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here “n” signifies participants evaluated at that time point.||participants|||Number
714501|NCT00232180|Secondary|Number of Participants With First Occurrence of All-Cause Mortality (Adjudicated)|Death due to any cause.|Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)|FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here “n” signifies participants evaluated at that time point.||participants|||Number
714502|NCT00232180|Secondary|Number of Participants With First Occurrence of All-Cause Mortality or Heart Failure (HF) Hospitalization (Adjudicated)|Death due to any cause or first of occurrence HF hospitalization. HF hospitalization is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF as the primary reason for hospitalization as determined by the endpoint committee adjudicator.|Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)|FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here “n” signifies participants evaluated at that time point.||participants|||Number
714532|NCT00232596|Secondary|Number of Participants Who Experienced the Indicated Level of Exacerbation and Reduction in the 28-day Total Partial Seizure Frequency From Baseline During the Maintenance Phase|Participants who experienced an exacerbation from Baseline in the 28-day total partial seizure frequency were categorized as having a 0-25% or a >25% increase (EMEA endpoint). The number of participants experiencing a >0% reduction from Baseline in the 28-day total partial seizure frequency are also presented.|Baseline (Week -7 through Week 0), Week 7 through Week 18|ITT Population for EMEA review.||participants|||Number
714503|NCT00232180|Primary|Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF) (Adjudicated)|CV mortality is defined as death due to heart failure, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident (CVA), other CV cause (such as aneurysm or pulmonary embolism). Hospitalization due to HF is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF as the primary reason for hospitalization as determined by the endpoint committee adjudicator.|Baseline (30 March 2006) up to 59.5 months (complete DB phase: 18 March 2011)|FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol.||participants|||Number
714504|NCT00232180|Primary|Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF) (Adjudicated): Up to Cut-off Date|CV mortality is defined as death due to heart failure, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident (CVA), other CV cause (such as aneurysm or pulmonary embolism). Hospitalization due to HF is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF as the primary reason for hospitalization as determined by the endpoint committee adjudicator.|Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010)|Full analysis set (FAS) using intent-to-treat (ITT) principle: All randomized participants, followed for mortality, other major endpoints for duration of double blind treatment period, regardless of compliance with study drug and protocol. Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||participants|||Number
714505|NCT00232479|Secondary|Safety and Tolerability|the number of patients with grade 4 (severe) toxicities and or hospitalizations were measured to assess safety and tolerability|from the first dose of chemotherapy until surgery which was approximately 16 weeks.|48 patients signed an initial informed consent. 2 withdrew consent before treatment. 2 withdrew after starting treatment. Only 44 are evaluable for primary endpoint because 2 did not go for surgery.||participants|||Number
714506|NCT00232479|Primary|Number of Patients With Pathologic Complete Response (pCR)|pCR is defined as the absence of invasive tumor from the surgical specimen of breast and axilla which is obtained after the chemotherapy regimen has been delivered.|determined at the time of surgery which is approximately 16 weeks from the beginning of treatment|48 patients signed consent but only 44 were evaluable. To be evaluable the patient must have received at least one dose of chemo and then had surgery. Two patients withdrew consent before treatment and two patients did not have surgery. So 44 are evaluable for the primary endpoint||participants|||Number
714507|NCT00232505|Secondary|Progression-Free Survival|Time to disease progression of cetuximab or cetuximab + carboplatin as indicated by radiographic assessment|Every four months until progression, death of any cause, or end of data collection up to 40 months|||participants|||Number
714508|NCT00232505|Secondary|Overall Survival|Subjects will be contacted every 4 months after discontinuation of active treatment to assess survival.|Every four months until death of any cause or end of data collection up to 40 months|||participants surviving|||Number
714509|NCT00232505|Primary|Overall Disease Response Rate|Overall response rate of single agent cetuximab and cetuximab + carboplatin will be measured by radiographic response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria every 8 weeks until subject experiences disease progression. Overall response will be measured as complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD).Per RECIST v1.0 for target lesions and assessed by CT (spiral): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression|5 years|||Participants|||Count of Participants
714510|NCT00232544|Secondary|Daytime Vigilance|A measure of behavioral alertness. Specifically the metric we used was the mean reaction time, the time it took for a subject to respond to a visual stimulus (light displayed on a screen at random intervals) by hitting a button.|12 months|||ms||95% Confidence Interval|Mean
714511|NCT00232544|Primary|Objective CPAP Use|Mean nightly hours of CPAP use over 12 months|12 months|||log(hours/night)||95% Confidence Interval|Mean
714512|NCT00232557|Secondary|Participants With Oral Corticosteroid Use|Number of participants found to have any use of oral corticosteroids related to asthma during one year|1 year|||participants|||Number
714513|NCT00232557|Primary|Participants With Unscheduled Asthma-related Visits|Number of participants found to have any unscheduled office visits, emergency room visits, or hospitalizations that are related to asthma during one year.|1 year|||participants|||Number
714514|NCT00232583|Secondary|Quality of Life, Treatment Satisfaction, and Treatment Compliance||72months||||||
714515|NCT00232583|Secondary|Inflammatory Markers||72 months||||||
714516|NCT00232583|Secondary|Weight Change||72 months||||||
714517|NCT00232583|Secondary|Glycemic Control||72 months||||||
714518|NCT00232583|Secondary|Insulin Resistance (HOMA)||72 months||||||
714519|NCT00232583|Primary|Beta-cell Function|C-peptide AUC during a 3-HR MMCT|Change from 0 to 72 months|||ng*min/ml||Standard Deviation|Mean
714520|NCT00232596|Secondary|Number of Participants With a >=7% Increase in Body Weight During Weeks 2, 4, and 6 of theTitration Phase and Weeks 7, 8, 10, 14, and 18 of the Maintenance Phase|The number of participants with recorded weight gain of >=7% over their baseline weight was measured.|Weeks 2, 4, 6 of Titration Phase and Weeks 7, 8, 10, 14, and 18 of Maintenance Phase|Safety Population. Only participants who remained in the study at the indicated week and who also had a body weight assessment were analyzed.||participants|||Number
714533|NCT00232596|Secondary|Number of Participants With the Indicated Reduction From Baseline in the 28-day Total Partial Seizure Frequency During the Maintenance Phase|Participants who experienced a reduction from Baseline in the 28-day total partial seizure frequency were categorized as having a >75%, a 50-75%, or a <50% reduction, in addition to having no reduction (EMEA endpoint).|Baseline (Week -7 through Week 0), Week 7 through Week 18|ITT Population for EMEA review||participants|||Number
714521|NCT00232596|Secondary|Change From Baseline in Post-void Residual Urine Volume at Weeks 10 and 18 of the DB Treatment Phase|Post-void residual (PVR) urine refers to the amount of urine remaining in the bladder after normal urination. To investigate the possible effects of retigabine on bladder function, all participants underwent post-void residual bladder ultrasound at Baseline and during the Maintenance Phase. The PVR bladder ultrasound was performed by a urologist, a qualified ultrasound technician, or a qualified study nurse who was certified to do PVR bladder ultrasound. Change from Baseline in PVR residual volume was calculated as the values at Week 10 and Week 18 minus the value at Baseline.|Baseline (Week -7 through Week 0), Weeks 10 and 18|Safety Population. Only participants who remained in the study at the indicated week and who also had a PVR assessment were analyzed.||milliliters||Full Range|Median
714522|NCT00232596|Secondary|Number of Participants Who Reported the Indicated Renal and Urinary Disorder Adverse Events at a Frequency Threshold of 2% (in Any Treatment Arm)|A summary of the adverse events classified as renal or urinary disorders and in which at least 2% (rounded to an integer) of participants in any treatment arm reported during the study is presented.|Week 1 through Week 24|Safety Population||participants|||Number
714523|NCT00232596|Secondary|Number of Participants Whose Clinical Laboratory Values Were Deemed an Adverse Event by the Investigator (>=2% in Any Treatment Arm)|Clinically important changes in laboratory values were to be reported as an adverse event if they met one of the following criteria: (1) intervention required; (2) change in dose of study drug required; (3) other treatment/therapy required; (4) association with other diagnoses.|Week 1 through Week 24|Safety Population||participants|||Number
714524|NCT00232596|Secondary|Quality of Life (QOL) Assessed by QOL in Epilepsy-Problems Questionnaire (QOLIE-31-P) at Baseline (Week 0) and Weeks 6, 10, and 18|The QOLIE-31-P is a 31-item questionnaire evaluating a participant's QOL perception in 7 domains: seizure worry, emotional well being, energy/fatigue, cognitive functioning, medication effects, social functioning, overall QOL. Precoded numeric values for some domains are such that a higher number reflects a more favorable health state; others are such that a higher number reflects a less favorable state. Precoded values are first converted to 0-100 point scores; higher converted scores always reflect better QOL. The overall score is derived by weighting and then summing the 7 domain scores.|End of Baseline (Week 0), Weeks 6, 10, and 18|Safety Population: all randomized participants who received at least 1 dose of retigabine or placebo. Participants who were cognitively impaired and could not complete the QOLIE-31-P assessment were not analyzed. The number of participants analyzed differs by week because not all participants completed the questionnaire at the indicated weeks.||scores on a scale||Standard Deviation|Mean
714525|NCT00232596|Secondary|Patient Global Impression (PGI) Score at the End of the Maintenance Phase|PGI is a participant-rated scale of improvement that was administered at the end of the Maintenance Phase in order to assess the participant's impression of his or her own improvement. PGI assessments were scored using a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.|Week 18/end of treatment phase|ITT Population for EMEA review. Only participants who had a PGI score were analyzed.||scores on a scale||Standard Deviation|Mean
714526|NCT00232596|Secondary|Clinical Global Impression-Improvement (CGI-I) Score at the End of the Maintenance Phase|Clinical Global Impression of Improvement (CGI-I) is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the treatment. Scores on the scale are rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.|Week 18/end of treatment phase|ITT Population for EMEA review. Only participants who had CGI-I scores were analyzed.||scores on a scale||Standard Deviation|Mean
714527|NCT00232596|Secondary|Percentage of Seizure-free Days During the Maintenance Phase|A seizure-free day was a day without any seizures. The percentage of seizure-free days was calculated as the total number of days without seizures in the DB period divided by the number of days in the DB period x 100%.|Week 7 through Week 18|ITT Population for EMEA review||percentage of days||Full Range|Median
714528|NCT00232596|Secondary|Percentage of Seizure-free Days During the DB Phase (Titration and Maintenance Phases)|A seizure-free day was a day without any seizures. For a participant to be seizure free during the DB Phase, the participant had to be seizure free both Week 7 to Week 18 and Week 1 to Week 6. A participant could be seizure free Week 7 to Week 18 (during the Maintenance Phase), but not seizure free Week 1 to Week 6. Hence, there are fewer participants being reported as seizure free from Week 1 to Week 18 than from Week 7 to Week 18. The percentage of seizure-free days was calculated as the total number of days without seizures in the DB period divided by the number of days in DB period x 100%.|Week 1 through Week 18|ITT Population for FDA review. Only participants who had post-baseline seizure data were included in the analysis.||percentage of days||Full Range|Median
714529|NCT00232596|Secondary|Number of Participants Who Were Seizure-free During the Maintenance Phase|Participants were considered to be seizure-free if they had not reported any seizures during the Maintenance Phase.|Week 7 through Week 18|ITT Population for EMEA review||participants|||Number
714530|NCT00232596|Secondary|Number of Participants Who Were Seizure-free During the DB Phase (Titration and Maintenance Phases)|Participants were considered to be seizure-free if they had not reported any seizures during the DB treatment period (Weeks 1-18). For a participant to be seizure free during the DB Phase, the participant had to be seizure free both Week 7 to Week 18 and Week 1 to Week 6. A participant could be seizure free Week 7 to Week 18 (during the Maintenance Phase), but not seizure free Week 1 to Week 6. Hence, there are fewer participants being reported as seizure free from Week 1 to Week 18 than from Week 7 to Week 18.|Week 1 through Week 18|ITT Population for FDA review. Only participants who had post-baseline seizure data were included in the analysis.||participants|||Number
714531|NCT00232596|Secondary|Number of Participants Reporting New Seizure Types in the Indicated Categories During the DB Phase (Titration and Maintenance Phases) That Were Not Reported at Baseline|New seizure types included those seizures which were not reported by any participant at Baseline.|Baseline (Week -7 through Week 0), Week 1 through Week 18|ITT Population for FDA review||participants|||Number
714565|NCT00233103|Secondary|BAI|The Beck Anxiety Inventory (BAI) is a 21-item self-report measure that assesses subjective, somatic, or panic-related symptoms associated with anxiety rated on a scale from 0 (not at all) to 3(severely). Total score: 0-7 = minimal level of anxiety, 8-15 = mild anxiety, 16-25 = moderate anxiety, and 26-63 = severe depression|Immediately post-intervention|||units on a scale||Standard Deviation|Mean
714534|NCT00232596|Secondary|Number of Participants With a Reduction in the 28-day Total Partial Seizure Frequency From Baseline to the End of the DB Phase (Titration and Maintenance Phases) by Indicated Decile Reduction and Increase Categories|Participants who experienced a reduction from Baseline in the 28-day total partial seizure frequency were categorized in decile cutting, i.e., reduction categories of 90-100%, 80-<90%, 70-<80%, 60-<70%, 50-<60%, 40-<50%, 30-<40%, 20-<30%, 10-<20%, >0-<10%, and increase categories of 0-10%, >10-20%, >20-30%, >30% (FDA endpoint). Participants without any post-baseline data were included in the 0-10% increase category.|Baseline (Week -7 through Week 0), Week 1 through Week 18|ITT Population for FDA review||participants|||Number
714535|NCT00232596|Secondary|Number of Participants With a Reduction in the 28-day Total Partial Seizure Frequency From Baseline to the End of DB Phase (Titration and Maintenance Phases) by Indicated Quartile Reduction Categories|Participants who experienced a reduction from Baseline in the 28-day total partial seizure frequency were categorized as having a reduction of 75-100%, 50-<75%, 25-<50%, or <25%, in addition to having no reduction. This quartile cutting was specified in the study protocol. Participants without any post-baseline data were included in the “No reduction” category.|Baseline (Week -7 through Week 0), Week 1 through Week 18|ITT Population for FDA review||participants|||Number
714536|NCT00232596|Secondary|Percent Change From Baseline (BL) in the 28-day Total Partial Seizure Frequency During the Maintenance Phase|28-day total partial seizure frequency in the BL period = (No. of total partial seizures reported in the BL period divided by the No. of days of available total partial seizure data in the BL period) x 28 days. 28-day total partial seizure frequency in the Maintenance Phase = (No. of total partial seizures reported in the Maintenance Phase divided by the No. of days of available total partial seizure data in the same phase) x 28 days. Percent change = (value in the Maintenance Phase minus value at BL divided by the BL value) x 100%. Negative values indicate a reduction in seizure frequency.|Baseline (Week -7 through Week 0), Week 7 through Week 18|ITT Population for EMEA review||percent change in seizure frequency||Full Range|Median
714537|NCT00232596|Secondary|Number of Participants Who Were Responders and Non-responders in the DB Phase|Responders were participants with at least a 50% reduction in the 28-day total partial seizure frequency in the DB Phase as compared to the Baseline period. Participants without any post-baseline data were considered non-responders.|Week 1 through Week 18|ITT Population for FDA review||participants|||Number
714538|NCT00232596|Primary|Number of Participants Who Were Responders and Non-responders in the Maintenance Phase|Responders were participants with at least a 50% reduction in the 28-day total partial seizure frequency in the Maintenance Phase as compared to the Baseline period.|Week 7 through Week 18|Intent-to-Treat (ITT) Population for European Medicines Agency (EMEA) review: all randomized participants who received at least one dose of study drug in the Maintenance Phase and had at least one seizure measurement (whether or not they had a seizure) recorded in the Maintenance Phase||participants|||Number
714539|NCT00232596|Primary|Percent Change in the 28-day Total Partial Seizure (PS) Frequency From Baseline (BL) to the End of the Double-blind (DB) Phase (Titration and Maintenance Phases)|28-day total PS (PSs [also called focal seizures] are seizures limited to a specific area of the brain) frequency in the BL period = (Number [No.] of total PSs reported in the BL period divided by the No. of days of available total PS data in the BL period) x 28 days. 28-day total PS frequency in the DB period = (No. of total PSs reported in the DB period divided by the No. of days of available total PS data in the DB period) x 28 days. Percent change = ([value in the DB period minus value at BL] divided by the BL value) x 100%. Negative values indicate a reduction in seizure frequency.|Baseline (Week -7 through Week 0), Week 1 through Week 18|Intent-to-Treat (ITT) Population for Food and Drug Administration (FDA) review: all randomized participants (par.) who received at least one dose of the study drug. Only par. with baseline and post-baseline measures were analyzed. Two par. in each treatment arm did not have post-baseline measures and were thus not included in this analysis.||percent change in seizure frequency||Full Range|Median
714540|NCT00232739|Secondary|Percentage of Participants Who Achieved Procedure Success Before Hospital Discharge|Procedure success defined as achievement of a final diameter stenosis of less than 50 percent (by QCA) using any percutaneous method, without the occurrence of death, MI, or repeat revascularization of the target lesion during the hospital stay|From post-procedure to hospital discharge|Number of participants without missing procedure success data||Percentage of participants||95% Confidence Interval|Mean
714541|NCT00232739|Secondary|Percentage of Participants Who Achieved Device Success at Post-procedure|Device success was defined as achievement of a final residual diameter stenosis of less than 50 percent as measured by QCA, using the assigned device only. If QCA is not available, the visual estimate of diameter stenosis is used|At post-procedure|All participants||Percentage of participants||95% Confidence Interval|Mean
714542|NCT00232739|Secondary|Percentage of Participants Who Achieved Lesion Success at Post-procedure|Lesion success defined as the attainment of <50 percent residual stenosis (by QCA) using any percutaneous method|At post-procedure|Number of Participants without missing lesion success data||Percentage of participants||95% Confidence Interval|Mean
714543|NCT00232739|Secondary|Average Stent Obstruction Volume at 6 Months Post-procedure||From post-procedure to 6 months|The number of participants with Stent Obstruction Volume data at 6 months post-procedure||mm3||Standard Deviation|Mean
714544|NCT00232739|Secondary|Average Lumen Volume (mm3) at 6 Months Post-procedure||From post-procedure to 6 months|The number of participants who had Lumen Volume data at 6 months post-procedure||mm3||Standard Deviation|Mean
714545|NCT00232739|Secondary|Average Stent Obstruction Volume at Post-procedure|Stent obstruction Volume equals 100 * [1-(lumen volume/baseline stent volume)]; usually this is equal to zero at baseline, since the stent is freshly implanted and no obstruction is expected|At post-procedure|Number of participants who had Stent Obstruction Volume data at post-procedure||mm3||Standard Deviation|Mean
714546|NCT00232739|Secondary|Average Lumen Volume (mm3) at Post-procedure||At Post-procedure|The number of participants who had lumen volume data at post-procedure||mm3||Standard Deviation|Mean
714547|NCT00232739|Secondary|Cumulative Percentages of Participants Who Experienced Any Target Vessel Failure (TVF) up to 6 and 9 Months Post-procedure|TVF was defined as any Target vessel revascularization, Q wave or non-Q wave MI, or cardiac death that could not be clearly attributed to a vessel other than the target vessel.|From post-procedure to 6 months and 9 months follow-up|The number of participants who had sufficient follow-up or who had an event prior to the end of follow-up.||Percentage of participants||95% Confidence Interval|Mean
714548|NCT00232739|Secondary|Cumulative Percentages of Participants Who Experienced Any Target Vessel Revascularization (TVR) up to 6 and 9 Months Post-procedure.|TVR was defined as any clinically driven repeat percutaneous intervention of the target vessel or bypass surgery of the target vessel. Clinically-driven revascularizations were those in which the patient has a positive functional study, ischemic ECG changes at rest in a distribution consistent with the target vessel, or ischemic symptoms, and an in-lesion diameter stenosis being greater than or equal to 50 percent measured by QCA.|From post-procedure to 6 months and 9 months follow-up|The number of participants who had sufficient 9 months post-procedure follow-up or had the event prior to 9 months.||Percentage of participants||95% Confidence Interval|Mean
714549|NCT00232739|Secondary|Cumulative Percentages of Participants Who Experienced Any Target Lesion Revascularization (TLR) up to 6 and 9 Months Post-procedure.|TLR was defined as any “clinically-driven” repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel.|From post-procedure to 6 months and 9 months|The number of participants who had sufficient follow-up or who had an event prior to the end of follow-up.||Percentage of participants||95% Confidence Interval|Mean
714550|NCT00232739|Secondary|Average In-stent and In-lesion Minimum Lesion Diameters (MLD) at 6 Months Post-procedure.||From post-procedure to 6 months|The number of participants with six months follow up and non-missing six months binary angiographic restenosis results.||mm||Standard Deviation|Mean
714551|NCT00232739|Secondary|Percentage of Participants Who Experienced Any Angiographic In-stent Binary Restenosis up to 6 Months Post-procedure.|In-stent restenosis was defined as greater than or equal 50 percent diameter stenosis within the stented segment at a qualifying follow-up angiogram.|From post-procedure to 6 months|The number of participants with six months follow up and non-missing six months binary angiographic restenosis results.||Percentage of participants||95% Confidence Interval|Mean
714552|NCT00232739|Secondary|Cumulative Percentages of Participants Who Experienced Any Major Adverse Cardiac Events up to Each Scheduled Follow-up|The percentages are cumulative up to each of the scheduled post-procedure follow-up: 30 days, 6, 9, and 12 months, and 2, 3, 4 and 5 years. Major Adverse Cardiac Events (MACE) consists of death, Myocardial Infarction (Q-wave and Non Q-wave), emergent Coronary Artery Bypass Graft (CABG) or Target Lesion Revascularization (TLR).|From post-procedure to 4 years|The number of participants who had four years post-procedure follow up or who had at least one event prior to the end of follow-up.||Percentage of participants||95% Confidence Interval|Mean
714553|NCT00232739|Primary|Percentage of Participants Who Experienced In-lesion Restenosis as Measured by Quantitative Coronary Angiography (QCA) at 6 Months Post-procedure|In-lesion restenosis was defined as over 50 percent diameter stenosis either within the stented segment or within 5 mm proximal or distal to the stent edges at a qualifying follow-up angiogram.|From post-procedure to 6 months|The number of participants with six months follow up and non-missing six months binary angiographic restenosis (BAR) results.||Percentage of participants||95% Confidence Interval|Mean
714554|NCT00233064|Primary|Number and Percentage of Participants With Immune Reactivity|Presence of anti-palivizumab antibodies|Day 240-300 follow up|Participants who received at least 2 doses of study drug and had at least 1 blood sample collected (at baseline or Study Day 240-300) were included in the analysis. This included 206 subjects in Arm 1 and 200 subjects in Arm 2. Of these subjects, 191 (Arm 1) and 188 (Arm 2) had adequate blood samples for analysis. This analysis was per protocol.||Participants|||Number
714555|NCT00233090|Secondary|Quality of Life|quality of life|comparison pre and post treatment|Study terminated due to low enrollment. data was not analyzed and is no longer available for analysis. Data not kept electronically and study records are no longer available.|||||
714556|NCT00233090|Secondary|Participation|participation|comparison pre and post treatment|Study terminated due to low enrollment. data was not analyzed and is no longer available for analysis. Data not kept electronically and study records are no longer available.|||||
714557|NCT00233090|Secondary|Health Status|health status|comparison pre and post treatment|Study terminated due to low enrollment. data was not analyzed and is no longer available for analysis. Data not kept electronically and study records are no longer available.|||||
714558|NCT00233090|Secondary|Sleep Quality|sleep quality|comparison pre and post treatment|Study terminated due to low enrollment. data was not analyzed and is no longer available for analysis. Data not kept electronically and study records are no longer available.|||||
714559|NCT00233090|Secondary|Pain|pain|comparison pre and post treatment|Study terminated due to low enrollment. data was not analyzed and is no longer available for analysis. Data not kept electronically and study records are no longer available.|||||
714560|NCT00233090|Secondary|Mood|mood|comparison pre and post treatment|Study terminated due to low enrollment. data was not analyzed and is no longer available for analysis. Data not kept electronically and study records are no longer available.|||||
714561|NCT00233090|Secondary|Cognitive Performance|Cognitive performance|comparison pre and post treatment|Study terminated due to low enrollment. data was not analyzed and is no longer available for analysis. Data not kept electronically and study records are no longer available.|||||
714562|NCT00233090|Primary|Fatigue|Self-report of fatigue|comparison pre and post treatment|Study terminated due to low enrollment. data was not analyzed and is no longer available for analysis. Data not kept electronically and study records are no longer available.|||||
714563|NCT00233103|Primary|Depression at End of Treatment|"Self-report of depression and Diagnostic and Statistical Manual Diploma in Social Medicine (DSM-IV) diagnosis (HAM-D score) compared at end of treatment to baseline. Participants were considered treatment responders if their initial HAM-D decreased by 50% or dropped below a score of 10 at the end of the intervention.
The 17-item Hamilton Rating Scale for Depression (HAM-D) is a widely used clinician-rated measurement of depression severity. A score of 0-7 is considered to be normal. 8-13 = mild depression, 14-18 = moderate depression, 19-22 = severe depression, and ≥ 23 = very severe depression."|end of treatment, average of 10 weeks|||units on a scale||Standard Deviation|Mean
714564|NCT00233103|Secondary|Life-3|Life-3 is a single-item Quality of life (QOL) measure that uses a 7-point Likert-type scale to assess satisfaction with life during the past month. It is typically administered twice during an evaluation, and the mean of the 2 obtained scores is used. Higher scores on this measure indicate higher levels of subjective QOL. Range from 1 to 7.|Immediately post-intervention at 10 weeks|||units on a scale||Standard Deviation|Mean
714588|NCT00233402|Secondary|Proportion of False Positive Lesions of Hexvix Cystoscopy and White Light Cystoscopy.|"The false detection rate for Hexvix cystoscopy was calculated as the total number of false positive lesions (i.e. lesions that were suspected with blue light but had negative histology according to the Standard of Truth central panel read) divided by the total number of lesions that were suspected with blue light (i.e., false positive divided by false positive plus true positive).
The corresponding false detection rates were also calculated for white light cystoscopy for the two groups separately."|Day 0|||Percetange of lesion||95% Confidence Interval|Number
714589|NCT00233402|Primary|Comparison of the Proportions of Patients in the White Light Cystoscopy and Hexvix Groups Who Underwent TURB for a Histologically-confirmed Ta or T1 Tumor Who Had a Recurrence ( CIS, Ta, T1 or T2-T4 Tumor) Within 9 Months.||9 months|ITT population||percentage of participants|||Number
714590|NCT00233402|Primary|Proportion of Patients With >= 1 Ta or T1 Tumor Detected With Blue Light and Not White Light||Day 0|Analysis was based on ITT population||percentage of participants||95% Confidence Interval|Number
714591|NCT00233454|Secondary|Overall Survival (OS)|Overall survival will be assessed after 12 cycles of treatment, with each cycle being 28 days (4 weeks) in length. 12 cycles of treatment is considered to be about 11 months.|11 months|||participants|||Number
714592|NCT00233454|Primary|Subjects With Clinical Response [Partial Response (PR) + Complete Response (CR)]|"Clinical Response [PR + CR] will be assessed after 2 cycles of treatment, with each cycle being 28 days (4 weeks) in length.
Except as otherwise noted, the minimum criteria for PR is improvement by at least 50% from the baseline value towards the indicated value for one or more of the criteria below:
BONE MARROW & BLOOD
ANC <1000/uL
Hb <10 g/dL
Platelets >100,000/uL LIVER
If hepatomegaly with ascites, decrease in frequency of paracenteses by 50%
Elevated enzyme levels > upper limit of normal (ULN)
Hypoalbuminemia < ULN
Portal hypertension > ULN SPLEEN
If palpable splenomegaly with hypersplenism/thrombocytopenia, hypersplenism markers improved GI TRACT
If malabsorption with hypoalbuminemia and/or weight loss, albumin improved BONES
If huge osteolyses or/and severe osteoporosis with pathologic fractures, partial resolution of osteolyses
Subjects with PR or greater continue, those without response discontinue."|2 months|||participants|||Number
714593|NCT00233519|Primary|The Number of Study Participants Who Safely Tolerated Somatokine|Safety and tolerability was measured via interval laboratory studies,electrocardiograms, echocardiograms, ultrasounds of the abdomen and pelvis, dual energy x-ray absorptiometry (DEXA) studies, chest and neck x-rays, and serial physical examinations. The participants had six inpatient evaluations at the University of Rochester General Clinical Research Center (Weeks 0, 8, 16, 24, 28, and 40) and nine outpatient evaluations. Patients also completed side effects diaries to record any adverse events in the interval time between inpatient and outpatient evaluations.|24 weeks|||participants|||Number
714594|NCT00233948|Primary|Overall Response Rate (Phase II)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|After 3 cycles of treatment, up to 2 years.|Patients who complete 3 cycles of treatment or who terminate treatment for reasons of toxicity, or who progress prior to the completion of 3 cycles of therapy on the Phase II portion of the study.||participants|||Number
714595|NCT00233948|Primary|Maximum Tolerated Dose (MTD) (Phase I)|The highest dose tested in which fewer than 33% of patients experience an attributable DLT to the study drug, when at least 6 patients are treated at that dose and are evaluable for toxicity. If PK analysis of 3 patients treated at 4250 mg bid and 3 patients at 3000 mg bid confirms that the first dose area under the curve and Cmax of nelfinavir does not increase appreciably at doses greater than 1875 mg BID then 3000 mg BID will be deemed the MTD.|4 weeks from start of treatment, up to 2 years|All patients observed for 28 days while receiving a full course of therapy or who experienced a DLT. Patients withdrawing before completion of the first course, for reasons other than DLT, were replaced.||mg|||Number
714596|NCT00233948|Primary|Dose Limiting Toxicity (DLT) (Phase I)|DLT is defined as any grade III toxicity not reversible to grade II or less within one week, or any grade IV toxicity. Hyperlipidemia, hyperglycemia, nausea, vomiting and diarrhea are not DLTs unless they are uncontrolled grade 3/4. Dose delays lasting more than 2 weeks due to toxicity are considered a DLT. Dose escalation schedule for nelfinavir: 1250 mg bid ; 1500 mg bid; 2125 mg bid; 3000 mg bid; 4250 mg bid ; 6000 mg bid ; 8500 mg bid ; 12000 mg bid|4 weeks from start of treatment, up to 2 years|All patients receiving treatment were evaluated for DLT.||participants with DLTs|||Number
714597|NCT00233987|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion|Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.||Participants|||Number
714598|NCT00233987|Secondary|Overall Survival|Measured from date of registration to date of death due to any cause or last contact|At day 60, then every 6 months for 2 years, then annually for a total of 7 years|All eligible patients who started treatment were included in the analysis||percentage of participants||95% Confidence Interval|Number
714599|NCT00233987|Secondary|Response Rate|Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.|At day 60, then every 6 months for 2 years|All eligible patients who started treatment were included in the analysis. Five patients with no evidence of disease at baseline were excluded.||participants|||Number
714600|NCT00233987|Primary|2-year Progression-free Survival|Measured from date of randomization to date of first observation of progressive disease, or death due to any cause|At day 60, then every 6 months for 2 years|All eligible patients who started treatment were included in the analysis||percentage of participants||95% Confidence Interval|Number
714601|NCT00234039|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|Patients were assessed for adverse events weekly for 6 weeks and then every 4 weeks for 40 weeks|Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.||Participants|||Number
714602|NCT00234039|Secondary|Recurrence-free Survival (RFS)|Recurrence-free Survival is defined as time from registration to first instance of disease recurrence, or death due to any cause.|1 year|All eligible patients who started treatment were included in the analysis||percentage of participants||95% Confidence Interval|Number
714603|NCT00234039|Primary|Complete Response Rate at the End of Induction|Complete Response is defined as negative cystoscopy with negative biopsy and no evidence of cancer on urine cytology at the Week 8 - 12 cystoscopy|Week 8-12, then every 3 months for the first 2 years, and then every 6 months for the years 3-5|All eligible patients who started treatment were included in the analysis||percentage of participants||95% Confidence Interval|Number
714604|NCT00234039|Secondary|Overall Survival (OS)|Measured from the day of registration to death due to any cause. Survival is censored at date of last contact.|1 year|All eligible patients who started treatment were included in the analysis||percentage of participants|||Number
714605|NCT00234065|Other Pre-specified|Number of Patients With First Occurrence of Haemorrhagic Event|The endpoint in this measure is a composite endpoint of the first occurrence of cerebral haemorrhage, subarachnoid haemorrhage or haemorrhage requiring hospital admission. The evaluation committee, whose members were unaware of patients’ treatment assignment, adjudicated all trial endpoints.|From start of treatment to end of follow-up period ( follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])|||participants|||Number
714606|NCT00234065|Secondary|Number of Patients With First Occurrence of a Composite Endpoint of Stroke, Haemorrhagic Events, or Cardiovascular Events|The endpoint in this measure is a composite endpoint of the first recurrence of cerebral infarction, or occurrence of cerebral haemorrhage, subarachnoid haemorrhage, transient ischaemic attack, angina pectris, myocardial infarction, heart failure, or haemorrhage requiring hospital admission. The evaluation committee, whose members were unaware of patients’ treatment assignment, adjudicated all trial endpoints.|From start of treatment to end of follow-up period ( follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])|||participants|||Number
714607|NCT00234065|Secondary|Number of Deaths From Any Cause|Number of deaths from any cause. The evaluation committee, whose members were unaware of patients’ treatment assignment, adjudicated all trial endpoints.|From start of treatment to end of follow-up period ( follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])|||participants|||Number
714608|NCT00234065|Secondary|Number of Patients With First Occurrence of Ischaemic Cerebrovascular Disease|The endpoint in this measure is a composite endpoint of the first recurrence of cerebral infarction or the first occurrence of transient ischaemic attack. The evaluation committee, whose members were unaware of patients’ treatment assignment, adjudicated all trial endpoints.|From start of treatment to end of follow-up period ( follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])|Analyses were done using the full analysis set (FAS) of patients, as predetermined in the protocol. The full analysis set excluded patients who failed to satisfy inclusion criteria and those who violated exclusion criteria.||participants|||Number
714609|NCT00234065|Secondary|Number of Patients With First Recurrence of Cerebral Infarction||From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])|||participants|||Number
714610|NCT00234065|Primary|Numbers of Patients With First Occurence of Stroke|The endpoint in this measure is a composite endpoint of the first recurrence of cerebral infarction, or occurrence of cerebral haemorrhage or subarachnoid haemorrhage. The evaluation committee, whose members were unaware of patients’ treatment assignment, adjudicated all trial endpoints.|From start of treatment to end of follow-up period ( follow-up periods : 29 months [Standard Deviation 16, range 1-59 months])|Analyses were done using the full analysis set (FAS) of patients, as predetermined in the protocol. The full analysis set excluded patients who failed to satisfy inclusion criteria and those who violated exclusion criteria.||participants|||Number
714611|NCT00234078|Post-Hoc|Change in Lissamine Green Conjunctival Staining (LGCS) Score From Baseline to Week 12|LGCS indicates the damage to the conjunctival epithelium. Per the National Eye Institute/Industry Workshop report, the conjunctiva was divided into 6 fractions, each of which was given a staining score from 0 to 3, and the total score was calculated (0-18). 0 is better. The CFB in the LGCS scores were compared between the 0.5, 1 and 2% rebamipide group and the placebo group using a Dunnett’s t-test.|Baseline, 12weeks|From the FAS of 290 patients, 218 patients who had no punctal plug insertion or punctal occlusion and who had a baseline schirmer test value of equal to or less than 5 mm for the eye evaluated for efficacy were selected and subjected to exploratory data analysis||scores on a scale||Standard Deviation|Mean
714612|NCT00234078|Post-Hoc|Change in Fluorescein Corneal Staining (FCS) Score From Baseline to Week 12|FCS indicates the damage to the corneal epithelium. Per the National Eye Institute/Industry Workshop report, the cornea was divided into 5 fractions, each of which was given a staining score from 0 to 3, and the total score was calculated (0-15). 0 is better. The CFB in the FCS scores were compared between the 0.5, 1 and 2% rebamipide group and the placebo group using a Dunnett’s t-test|Baseline, 12week|From the FAS of 290 patients, 218 patients who had no punctal plug insertion or punctal occlusion and who had a baseline schirmer test value of equal to or less than 5 mm for the eye evaluated for efficacy were selected and subjected to exploratory data analysis||scores on a scale||Standard Deviation|Mean
714613|NCT00234078|Primary|Change in Primary Ocular Discomfort (POD) Score From Baseline to Last Observation Carried Forward (LOCF)|POD indicates the ocular symptom most bothersome to the patient. POD selected by each patient from among the following ocular symptoms; Foreign body sensation, Dryness, Photophobia, Eye pain and Blurred vision. POD was scored from 0 through 4; a score of 0 indicated no symptoms and a score of 4 indicated very severe symptoms. 0 is better. The change from baseline (CFB) to LOCF at the end of instillation (LOCF endpoint) was used to analyze dose-response. A general linear model was used to examine if slope parameters were not equal to zero.|Baseline, 12 weeks|||scores on a scale||Standard Deviation|Mean
714614|NCT00234078|Primary|Change in Fluorescein Corneal Staining (FCS) Score From Baseline to Last Observation Carried Forward (LOCF)|FCS indicates the damage to the corneal epithelium. Per the National Eye Institute/Industry Workshop report, the cornea was divided into 5 fractions, each of which was given a staining score from 0 to 3, and the total score was calculated (0-15). 0 is better. The change from baseline (CFB) to LOCF at the end of instillation (LOCF endpoint) was used to analyze dose-response. A general linear model was used to examine if slope parameters were not equal to zero.|baseline, 12 weeks|||scores on a scale||Standard Deviation|Mean
714615|NCT00234104|Primary|Body Weight|The body weight change from baseline following final trial drug administration|Baseline, at the time of final trial drug administration|1 Subject of Placebo arm who experienced a serious adverse event was excluded from efficacy analysis set because the emergency code was broken.||Kg||Standard Deviation|Mean
714616|NCT00234286|Secondary|Individuals With a Palliative Care Consultation|Palliative Care Consultation based on abstraction of medical record|Pre and Post Intervention|||participants|||Number
714617|NCT00234286|Secondary|Individuals With an Advance Directive|Presence of advance directive based on abstraction of medical record|Pre and Post Intervention|||participants|||Number
714618|NCT00234286|Secondary|Individuals With Pastoral Care Visit|Pastoral Care Visit based on abstraction of medical record|Pre and Post Intervention|||participants|||Number
714619|NCT00234286|Secondary|Sublingual Administration|Sublingual administration of medication based on abstraction of medical record|Pre and Post Intervention|||participants|||Number
714620|NCT00234286|Secondary|Individuals Who Received Scopolamine|Administration of scopolamine (for death rattle) based on abstraction of medical record|Pre and Post Intervention|||participants|||Number
714621|NCT00234286|Secondary|Individuals Who Received Benzodiazepine Medication|Administration of benzodiazepine medication based on abstraction of medical record|Pre and Post Intervention|||participants|||Number
714622|NCT00234286|Secondary|Individuals With an Order for Benzodiazepine Medication|Order for benzodiazepine medication based on abstraction of medical record|Pre and Post Intervention|||participants|||Number
714623|NCT00234286|Secondary|Individuals Administered Antipsychotic Medication|Administration of antipsychotic medication based on abstraction of medical record|Pre and Post Intervention|||participants|||Number
714624|NCT00234286|Secondary|Individuals With an Order for Antipsychotic Medication|Order for antipsychotic medication based on abstraction of medical record|Pre and Post Intervention|||participants|||Number
714625|NCT00234286|Secondary|Individuals Administered of Opioid Medication|Administration of opioid medication based on abstraction of medical record|Pre and Post Intervention|||participants|||Number
714626|NCT00234286|Secondary|Number of Individuals Who Died in Restraints|Presence of restraints at or near time of death at time of death based on abstraction of electronic medical record|Pre and Post Intervention|||participants|||Number
714627|NCT00234286|Secondary|Individuals With an Intravenous Line|Presence of intravenous line infusing at time of death based on abstraction of electronic medical record|Pre and Post Intervention|||participants|||Number
714628|NCT00234286|Secondary|Individuals With a Nasogastric Tube|Presence of nasogastric tube based on abstraction of electronic medical record|Pre and Post Intervention|||participants|||Number
714629|NCT00234286|Secondary|Number of Patients Who Died in ICU|Location of death (ICU vs. other) based on abstraction of electronic medical record|Pre and Post Intervention|||participants|||Number
714630|NCT00234286|Secondary|Do Not Resuscitate Order|Presence of a Do Not Resuscitate order at time of death based on abstraction of electronic medical record|Pre and Post Intervention|||participants|||Number
714631|NCT00234286|Primary|Presence of Order for Opioid Pain Medication|Presence of order for opioid pain medication at time of death based on abstraction of electronic medical record|Pre and Post Intervention|||participants|||Number
714632|NCT00239928|Primary|Summary of Adverse Events|Number of subjects with serious and non-serious adverse events: Subjects with ophthalmic adverse events: Subjects with severe adverse events that interferes significantly with subject's usual function: Subjects discontinued due to adverse events: Subjects with dose reduction or temporary discontinuation due to adverse events|Week 54 (initiation of A5751015 study) up to Week 198|Intent-to-treat||participants|||Number
714633|NCT00239928|Secondary|Number of Subjects With Severe Vision Loss From Baseline of A5751010 (NCT 00150202)|Subjects with severe vision loss: loss from baseline of >= 30 letters of visual acuity.|Week 0 (baseline), every 18 weeks from Week 54 up to Week 198|"Among Intent-to-treat, 8 subjects who entered the current study 14 days or more after the completion of Study A5751010 (NCT00150202) were excluded from Intent-to-treat.
Last Observation Carried Forward"||participants|||Number
714634|NCT00239928|Secondary|Number of Subjects Who Are Maintaining Vision From Baseline of A5751010 (NCT 00150202)|Maintaining vision includes gaining 0 letter or more in visual acuity using Early Treatment Diabetic Retinopathy Study chart from baseline.|Week 0 (baseline), every 18 weeks from Week 54 up to Week 198|"Among Intent-to-treat, 8 subjects who entered the current study 14 days or more after the completion of Study A5751010 (NCT 00150202) were excluded from Intent-to-treat.
Last Observation Carried Forward"||participants|||Number
714635|NCT00239928|Secondary|Number of Subjects Gaining Vision From Baseline of A5751010 (NCT00150202)|Subjects gaining vision: gain from baseline of more than 15 letters of visual acuity.|Week 0 (baseline), every 18 weeks from Week 54 up to Week 198|"Among Intent-to-treat, 8 subjects who entered the current study 14 days or more after the completion of Study A5751010 (NCT00150202) were excluded from Intent-to-treat.
Last Observation Carried Forward"||participants|||Number
714636|NCT00239928|Secondary|Number of Responders|Responders defined as subjects having lost from baseline of A5751010 (NCT00150202) less than 15 letters of visual acuity; includes subjects with visual acuity gain.|Week 0 (baseline), every 18 weeks from Week 54 up to Week 198|"Among Intent-to-treat, 8 subjects who entered the current study 14 days or more after the completion of Study A5751010 were excluded from Intent-to-treat.
Last Observation Carried Forward"||participants|||Number
714987|NCT00247273|Secondary|Change From Baseline in Serum Type-1 Collagen Cross-linked C-telopeptide (CTX) at Month 6, ITT Population|ng / mL = nanograms / milliliter. Assayed by electrochemiluminescent immunoassay.|Baseline to Month 6|ITT||ng / mL||95% Confidence Interval|Least Squares Mean
714637|NCT00239928|Secondary|Mean Change in Visual Acuity From the Starting Point of Current Study to Each Observation Time Point|"Value at each observation time point minus value at Week 54 (initiation of current study).
Visual acuity was measured as number of letters that the participants for this study could read in Early Treatment Diabetic Retinopathy Study (ETDRS) chart (eyesight-test chart).The best value in visual acuity using ETDRS chart is 85 and the worst value in visual acuity is 0."|Weeks 54, every 18 weeks from Week 54 up to Week 198|"Intent-to-treat, Among 61 subjects, for efficacy analyses, 1 subject had missing data at Week 72.
Last Observation Carried Forward"||letters||Standard Deviation|Mean
714638|NCT00239928|Secondary|Mean Change in Visual Acuity From Baseline of A5751010 (NCT00150202) to Each Observation Time Point|"Change: value at each observation time point minus value at baseline of A5751010 (NCT00150202).
Visual acuity was measured as number of letters that the participants for this study could read in Early Treatment Diabetic Retinopathy Study (ETDRS) chart (eyesight-test chart).The best value in visual acuity using ETDRS chart is 85 and the worst value in visual acuity is 0."|Week 0 (baseline), every 18 weeks from Week 54 up to Week 198|"Among Intent-to-treat, 8 subjects who entered the current study 14 days or more after the completion of Study A5751010 were excluded from Intent-to-treat.
Last Observation Carried Forward"||letters||Standard Deviation|Mean
714639|NCT00240071|Secondary|The Secondary Efficacy Outcome Will be Objective Response Rate (Defined as the Rate of Complete and Partial Responses.||Determined on two consecutive occasions at least 4 weeks apart.||||||
714640|NCT00240071|Primary|Progression Free Survival (PFS)|Progression free survival is defined as time from date of registration until the date of first documented disease progression or date of death from any cause, whichever occurs first.|From date of registration until disease progression or death, whichever occurs first|All participants entered onto study (intention to treat) (ITT) were analyzed.||days||95% Confidence Interval|Median
714641|NCT00240097|Primary|Response Rate After Relapse|The objective is to determine the objective tumor response rate of sequential topoisomerase targeting with irinotecan/oxaliplatin followed by etoposide/carboplatin in chemotherapy-naïve patients with extensive SCLC and Stage IIIb (wet) – IV Large Cell Carcinoma of the Lung with neuroendocrine markers. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Stable response means did not meet criteria for progressive or partical response. 20% progressive disease.|3 weeks after 3rd cycle of starting therapy after relapse or refractory disease|All subjects dropped out or died prior to experiencing relapse|||||
714642|NCT00240097|Secondary|Overall Survival (Part I)|Length of subject survival after starting study treatment|baseline to 2 years|||months||95% Confidence Interval|Median
714643|NCT00240097|Primary|Objective Response Rate (Part I)|The primary objective is to determine the objective tumor response rate of sequential topoisomerase targeting with irinotecan/oxaliplatin followed by etoposide/carboplatin in chemotherapy-naïve patients with extensive SCLC and Stage IIIb (wet) – IV Large Cell Carcinoma of the Lung with neuroendocrine markers. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Stable response means did not meet criteria for progressive or partical response. 20% progressive disease.|baseline to 18 months|||Participants|||Number
714644|NCT00240097|Secondary|Progression Free Survival (Part I)|Time to progressive disease|baseline to five years|||months||95% Confidence Interval|Median
714645|NCT00240110|Secondary|Change From Baseline in Percentage of Money Spent on Cocaine|Change from baseline in percentage of the amount of money spent on cocaine|week 12|All subjects with available data after assignment to study medications||Percentage of Money Spent on Cocaine||Standard Deviation|Mean
714646|NCT00240110|Primary|Change From Baseline in Percentage of Cocaine-abstinent Days|Change from baseline in percentage of self-report cocaine-abstinent (non-use) days (difference in base percent values)|Week 12|All subjects with available data after assignment to study medications||percentage of days cocaine abstinent||Standard Deviation|Mean
714647|NCT00240162|Secondary|Disease Free Survival||Until the patient expires|This secondary outcome was not analyzed.|||||
714648|NCT00240162|Secondary|Safety and Tolerability of PTK787/ZK 222584|Number of Grade 3/4 adverse events per the National Cancer Institute (NCI) Common Toxicity Criteria v 3.0.|30 days after treatment ends [median of 15 cycles (11-32)]|Only 13 out of the 21 participants experienced a grade 3 or 4 adverse event.||adverse events|||Number
714649|NCT00240162|Secondary|Time to Progression|"Time to progression is from the start of treatment until the first date that criteria for progressive disease (PD) are met.
25% increase in the level of the serum monoclonal paraprotein, which must also be an absolute increase of at least 0.5 g/dL and confirmed by at lease 1 repeated investigation.
25% increase in the 24 hr urinary light chain excretion, which must also be an absolute increase of at least 200 mg/ 24 hr and confirmed by at least 1 repeated investigation.
35% increase in plasma cells in a bone marrow aspirate or on trephine biopsy, which must also be an absolute increase of at least 10%.
Increase in the size of existing bone lesions or soft tissue plasmacytomas
New lytic bone lesions or soft tissue plasmacytomas or definite increase in the size of residual bone lesions (development of a compression fracture does not exclude continued response and may not indicate progression).
Hypercalcemia - corrected serum calcium > 11.5 mg/dL"|Until the patient progresses or expires (up to 457 days)|Participants were evaluable for time to progression if they completed 3 cycles of treatment. 10 out of 21 participants completed 3 cycles of treatment.||days||Full Range|Median
714650|NCT00240162|Primary|Detectable Paraprotein Level (IgG or IgA)at ≤5 g/dL Who Show a 50% Reduction (Complete Response + Partial Response) in Their Paraprotein After Starting Treatment With the Study Drug||Day 90|Participants were evaluable for response if they completed 3 cycles of treatment. 10 out of 21 participants completed 3 cycles of treatment.||participants|||Number
714651|NCT00240227|Secondary|Change in Urine Drug Analysis Results Between Study Medication and Placebo Periods||4 weeks||||||
714652|NCT00240227|Secondary|Change in Self-reports of Substance Use Between Study Medication and Placebo Periods||4 weeks||||||
714653|NCT00240227|Secondary|Change in Subjective Experience of Craving in Response to Provocative Visual Cues Designed to Elicit Craving, as Measured by the Within Session Rating for Cocaine/Alcohol Craving||During lab session||||||
714661|NCT00241904|Secondary|Patients' Satisfaction With Care and Health Care Utilization|Patient satisfaction with care and healthcare utilization was measured with the Patient Assessment for Chronic Illness Care Scale (PACIC). The scores range from 0-5, with 5 being the most satisfied|Measured at 1 year|||units on a scale||Standard Deviation|Mean
714662|NCT00241904|Primary|HbA1c|Fasting for 12 hour blood sample was measured in standardized lab|Measured at 1 year|Only the participants with a diagnosis of diabetes were assessed for this outcome measure||percentage of hemoglobin||Standard Deviation|Mean
714663|NCT00241904|Primary|Systolic Blood Pressure|Blood pressure measured with automatic blood pressure machine according to the guidelines of the American Heart Association.|Measured at 1 year|||mmHg||Standard Deviation|Mean
714664|NCT00241904|Primary|Low-density Lipoprotein Cholesterol|Blood was drawn after a 12 hour fast and low density lipoprotein cholesterol was measured in a standardized lab|Measured at 1 year|||mg/dL||Standard Deviation|Mean
714665|NCT00242216|Secondary|CD4 Cell Count Change From Baseline During Treatment.||24 weeks.|||cell/mm3||Standard Deviation|Mean
714666|NCT00242216|Primary|Proportion of Patient With Viral Load Less Than 400 Copies/mL||24 weeks|||percentage|||Number
714667|NCT00242385|Secondary|Adverse Events (AEs)|"Investigators assessed severity of AEs (occurring during or after infusions) based on:
MILD: Transient discomfort, does not interfere in a significant manner with participant’s normal functioning level; Resolves spontaneously or may require minimal therapeutic intervention MODERATE: AE produces limited impairment of function, can require therapeutic intervention; AE produces no sequelae; SEVERE: AE results in marked impairment of function, can lead to temporary inability to resume usual life pattern; AE produces sequelae, which require prolonged therapeutic intervention"|Throughout study period (7 months)|Safety Analysis Data Set - all study subjects who had evidence of receiving at least one dose of study medication regardless of any protocol violation.||Events|||Number
714668|NCT00242385|Secondary|Incremental Recovery|Computed from Cmax (mg/ml) divided by dose per kg body weight (mg/kg).|Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion|Full Analysis Data Set - all study subjects who received at least 1 dose of study product, and provided data suitable for pharmacokinetic analysis||(mg/mL) / (mg/kg)||Full Range|Median
714669|NCT00242385|Secondary|Time to Maximum α1-PI Concentration Post-infusion (Tmax)|Time to reach C-max. Tmax is the number of days from infusion to maximum concentration. Samples drawn at the end of infusion are considered to be time zero.|Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion|Full Analysis Data Set - all study subjects who received at least 1 dose of study product, and provided data suitable for pharmacokinetic analysis||days||Full Range|Median
714670|NCT00242385|Secondary|Maximum Plasma Concentration (Cmax)|Maximum α1-PI concentration following infusion|Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion|Full Analysis Data Set - all study subjects who received at least 1 dose of study product, and provided data suitable for pharmacokinetic analysis||mg/mL||Full Range|Median
714671|NCT00242385|Secondary|Terminal Half-life|Computed from the terminal or disposition rate constant obtained from log_e -linear fitting using the least squares deviation to the last five quantifiable concentrations above pre-infusion level.|Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion|Full Analysis Data Set - all study subjects who received at least 1 dose of study product, and provided data suitable for pharmacokinetic analysis||days||Full Range|Median
714672|NCT00242385|Secondary|Apparent Volume of Distribution at Steady State|Computed as weight-adjusted CL * MRT|Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion|Full Analysis Data Set - all study subjects who received at least 1 dose of study product, and provided data suitable for pharmacokinetic analysis||mL||Full Range|Median
714673|NCT00242385|Secondary|Mean Residence Time (MRT)|Computed as total area under the moment curve (AUMC) divided by total AUC|Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion|Full Analysis Data Set - all study subjects who received at least 1 dose of study product, and provided data suitable for pharmacokinetic analysis||days||Standard Deviation|Mean
715007|NCT00247377|Secondary|Changes in Quality of Life- Physical Functioning Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation|change in quality of life survey response where 0 is non-functioning and 100 is fully functioning|Baseline to 12 months|||units on a scale||Standard Deviation|Mean
714674|NCT00242385|Secondary|Systemic Clearance (CL)|Computed as dose divided by AUC 0-infinity (AUC 0-infinity was calculated as the sum of AUC from time 0 to the time of last quantifiable concentration plus a tail area correction)|Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion|Full Analysis Data Set - all study subjects who received at least 1 dose of study product, and provided data suitable for pharmacokinetic analysis||mL/day||Full Range|Median
714675|NCT00242385|Secondary|Total Area Under the Curve Per Dose|Total area under the α1-PI concentration vs. time curve from pharmacokinetic day 0 to time infinity (AUC 0-infinity) per dose|Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion|Full Analysis Data Set - all study subjects who received at least 1 dose of study product, and provided data suitable for pharmacokinetic analysis||days*kg/mL||Full Range|Median
714676|NCT00242385|Primary|Area Under the Curve/Dose|Area under the plasma alpha1-proteinase inhibitor (α1-PI) concentration versus time curve (AUC) calculated by linear trapezoidal method per dose.|Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion|All study subjects who received at least 1 dose of study product, and provided data suitable for pharmacokinetic analysis||days*kg/mL||Full Range|Median
714677|NCT00242502|Primary|Progression-free Survival (PFS) Rate|Progression free survival (PFS) at 16 weeks of treatment with the combination of Avastin and erlotinib where participant said to be failure free at 16 weeks if they are alive, and their disease has not progressed. PFS Rate is number of participants with PFS at 16 weeks out of total participants. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Baseline to 16 weeks|Six participants were not evaluable.||percentage of participants|||Number
714678|NCT00242567|Secondary|Time to Occurrence of Skeletal Related Event or Death|Time from randomization to the first detected skeletal related event or death. This endpoint is the same as the primary endpoint with the modification that deaths are considered events.|36 Months|The ITT Population consisted of all patients randomized to treatment.||Days||95% Confidence Interval|Median
714679|NCT00242567|Secondary|Skeletal-related Event(SRE)-Free Survival|Time from randomization until the first detected SRE. Patients who were still SRE-free at 3 years were censored.|36 months|The ITT Population consisted of all patients randomized to treatment.||Days||95% Confidence Interval|Median
714680|NCT00242567|Secondary|Time to Occurrence of Skeletal Related Event or Death|Time from randomization to the first detected skeletal related event or death. This endpoint is the same as the primary endpoint with the modification that deaths are considered events.|18 Months|The ITT Population consisted of all patients randomized to treatment.||Days||95% Confidence Interval|Median
714681|NCT00242567|Secondary|Overall Survival at 18 Months and 3 Years|Overall survival (OS) time was measured from the start of study drug to the date of death due to any cause.|month 18, year 3|The ITT Population will consist of all patients randomized to treatment.||participants|||Number
714682|NCT00242567|Primary|Skeletal-related Event-free Survival in Men With Bone Metastases From Prostate Cancer|Skeletal-related event free survival is the time from randomization until the first detected Skeletal Related Event (SRE). Patients who were still SRE-free at 18 months were censored.|18 months|The ITT Population will consist of all patients randomized to treatment.||participants|||Number
714683|NCT00242580|Secondary|Mean Change From Baseline in Total Area of Lesion at 12 Months|Fluorescein angiography (FA) was used to assess total lesion area. All angiographs were sent to the Central Reading Center (CRC) for analysis.|Baseline to Month 12|Intent-to-treat (ITT) data set includes data from all randomized patients. Missing data were imputed using last observation carried forward.||mm^2||Standard Deviation|Mean
714684|NCT00242580|Secondary|Number of Participants Requiring Verteporfin Treatment Throughout the Study|Participants received study drug at the Baseline visit and subsequent retreatment at 3 month intervals if leakage was detected on the fluorescein angiogram. The cumulative distribution of the number of treatments is shown per arm.|Baseline to Month 12|Observed data.||Participants|||Number
714685|NCT00242580|Secondary|Percentage of Participants With Gain of BCVA Score of 15 or More Letters at Month 12|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained 15 or more letters of visual acuity at 12 months as compared with baseline.|Baseline to Month 12|Efficacy variable analyses were performed on the intent-to-treat (ITT) data set. The ITT set includes data from all randomized patients. Missing data were imputed using last observation carried forward.||Percentage of Participants|||Number
714686|NCT00242580|Secondary|Percentage of Participants With Gain of BCVA of 10 or More Letters at 12 Months|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained 10 or more letters of visual acuity at 12 months as compared with baseline.|Baseline to Month 12|Intent-to-treat (ITT) data set includes data from all randomized patients. Missing data were imputed using last observation carried forward.||Percentage of Participants|||Number
714687|NCT00242580|Secondary|Percentage of Participants With Gain of 5 or More Letters of Best Corrected Visual Acuity From Baseline to Month 12|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained 5 or more letters of visual acuity at 12 months compared with baseline.|Baseline to Month 12|Intent-to-treat (ITT) data set includes data from all randomized patients. Missing data were imputed using last observation carried forward.||Percentage of Participants|||Number
714709|NCT00243022|Secondary|Overall Survival: Percentage of Patients That Were Alive at 1 Year|Overall survival will be measured from the date of enrollment to date of death or last contact. Survival will be evaluated by the Kaplan Meier method to evaluate the median survival and 1 year survival rates.|1 year.|All 12 patients followed to death or censored at last visit when known alive||percentage of particpants||95% Confidence Interval|Number
714688|NCT00242580|Primary|Percentage of Participants Who Lose Less Than 15 Letters of Best Corrected Visual Acuity (BCVA) at 12 Months From Baseline.|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. A decrease in score indicates worsening of vision. This outcome assessed the percentage of participants who lost less than 15 letters of visual acuity at 12 months as compared with baseline.|Baseline to Month 12|Intent-to-treat (ITT) data set includes data from all randomized patients. Missing data were imputed using last observation carried forward.||Percentage of Participants|||Number
714689|NCT00242619|Primary|Clinical Global Impression-Severity Scale (CGI-S)|The Clinical Global Impression-Severity Scale (CGI-S) assesses depression severity. It is a 7-point scale, where 1 is the lowest level of depression severity and 7 is the highest level of depression severity.|12 weeks|||units on a scale||Standard Deviation|Mean
714690|NCT00242619|Primary|Hamilton Depression Rating Scale (HDRS-21)|The Hamilton Depression Rating Scale (HDRS-21) measures depression severity on a scale from 0 to 21, with 0 being the lowest level of depression severity and 21 being the highest level of depression severity.|12 weeks|||units on a scale||Standard Deviation|Mean
714691|NCT00242632|Secondary|Change in Delis-Kaplan Executive Function System (DKEFS) Verbal Fluency Category Switching Between Time 1 and Time 2|The Delis-Kaplan Executive Function System (DKEFS) Verbal Fluency Category Switching test measures letter fluency, category fluency, and category switching. The score is the total number of correct words generated during each of the 60-second trials within the three conditions of the test. The mean difference in the total number of correct words generated between time 1 and time 2 is calculated below.|6 months|All participants were grouped together for this Outcome Measure. As per the protocol, the analyses of neuropsychological variables were to be done separately for the ApoE-ɛ4 carriers and non-carriers, only if the ApoE-ε4 status was a significant predictor of change in neuropsychological performance.||correct words||Standard Deviation|Mean
714692|NCT00242632|Primary|Change in California Verbal Learning Test - Second Edition Proactive Interference Test Between Time 1 and Time 2|This tests verbal memory (word list). A list of words is presented and subjects are asked to recall as many as they can. Then a list of interference words is presented. Finally a recognition list of 44 words is presented where subjects are asked to distinguish between target words and distractors. The mean difference in the percentage of target words recalled between time 1 and time 2 is calculated below.|6 months|All participants were grouped together for this Outcome Measure. As per the protocol, the analyses of neuropsychological variables were to be done separately for the ApoE-ɛ4 carriers and non-carriers, only if the ApoE-ε4 status was a significant predictor of change in neuropsychological performance.||percentage of target words recalled||Standard Deviation|Mean
714693|NCT00242658|Secondary|Change in Behavioral Processes of Change Between Baseline and 6 Months|"Behavioral processes were assessed by asking participants to rate their responses to 24 statements on a Likert scale (1 = never to 5 = repeatedly) to statements such as, I tell myself I am able to be physically active if I want to. To create the overall measure, individual items are averaged. Higher numbers represent greater use of behavioral processes of change, so that the overall scale retains a maximum of 5.0 and minimum value of 1.0. The scale values are not numerical, they represent scores on the scale, where 5=repeatedly and 1=never."|Baseline and 6 months|||Scores on a Scale||95% Confidence Interval|Mean
714694|NCT00242658|Primary|7-Day Physical Activity Recall (7-Day PAR)|Minutes of physical activity measured by the 7-Day Physical Activity Recall (7-Day PAR), which is an interviewer-administered self-report physical activity measure of minutes spent in moderate and vigorous intensity leisure and non-leisure activities over the preceding 7 days. It was administered to study participants at baseline and 6 months.|6 months|||minutes||95% Confidence Interval|Mean
714695|NCT00242684|Post-Hoc|Percentage of Subjects With Average Daily Nutrient Intake <90% of Predicted Needs||While hospitalized on TCU, for up to 40 days|||percentage of subjects|||Number
714696|NCT00242684|Primary|Percentage of Subjects With Average Daily Nutrient Intake <70% of Predicted Needs||While hospitalized on TCU, for up to 40 days|||percentage of subjects|||Number
714697|NCT00242710|Secondary|Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at Month 24|BMD measurements of the total hip were acquired by DXA, twice at Month 24 in participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. An average of the 2 readings was reported.|Baseline, Month 24|MITT population for BMD of total hip: all participants who took at least 1 dose of test article, participated in study extension, and had a baseline and at least 1 on-therapy evaluation of BMD (scans acquired more than 60 days after the test article administration was stopped were excluded) at Year 2. Missing values imputed using LOCF method.||percent change||Standard Error|Least Squares Mean
714698|NCT00242710|Secondary|Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 24|BMD measurements of the anteroposterior lumbar spine were acquired by DXA, twice at Month 24 in participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. An average of the 2 readings was reported.|Baseline, Month 24|MITT population for BMD of lumber spine: all participants who took at least 1 dose of test article, participated in study extension, and had a baseline and at least 1 on-therapy evaluation of BMD (scans acquired more than 60 days after the test article administration was stopped were excluded) at Year 2. Missing values imputed using LOCF method.||percent change||Standard Error|Least Squares Mean
714699|NCT00242710|Secondary|Percentage of Participants With Hyperplasia at Month 24|Endometrial hyperplasia was assessed by endometrial biopsies. All endometrial biopsies were read centrally by 2 primary pathologists. Participants were considered to have a diagnosis of hyperplasia if both pathologists read hyperplasia (simple hyperplasia with or without atypia or complex hyperplasia with or without atypia). If the both pathologists disagreed on the presence of hyperplasia, a third pathologist was consulted, with the final diagnosis determined by the majority opinion.|Month 24|EE analysis population for Year 2 included all randomized participants who took at least 1 dose of test article, participated in study extension, had a screening endometrial biopsy with readings by at least 2 blinded central pathologists, had biopsy during Month 24, or had hyperplasia diagnosed before Month 24 and had no major protocol violations.||percentage of participants||95% Confidence Interval|Number
714700|NCT00242710|Secondary|Percentage of Participants With Uterine Bleeding or Spotting|Data was collected every day after randomization up to Year 1 and was analyzed in 4 weeks intervals. Data for screening was not analyzed since data were collected only for 7 days at screening which was not considered comparable to 4-week post-baseline data.|Screening, Week 1 to 4, 5 to 8, 9 to 12, 13 to 16, 17 to 20, 21 to 24, 25 to 28, 29 to 32, 33 to 36, 37 to 40, 41 to 44, 45 to 48, 49 to 52|MITT population for uterine bleeding or spotting included all randomized participants who had received at least 1 dose of test article and had at least 1 day of on-therapy bleeding data. Imputation=LOCF. n=participants evaluable for this measure at specified time periods for each arm, respectively.||percentage of participants|||Number
714701|NCT00242710|Secondary|Percentage of Days With Breast Pain|Percentage of days with breast pain in each 4-week period (for example, Week 1 to 4, 5 to 8) calculated as the number of days on which a participants reported breast pain divided by total number of days with data recorded multiplied by 100. Data was collected every day after randomization up to Year 1 and was analyzed in 4 weeks intervals. Data for screening was not analyzed since data were collected only for 7 days at screening which was not considered comparable to 4-week post-baseline data.|Screening, Week 1 to 4, 5 to 8, 9 to 12, 13 to 16, 17 to 20, 21 to 24, 25 to 28, 29 to 32, 33 to 36, 37 to 40, 41 to 44, 45 to 48, 49 to 52|MITT population for breast pain: all randomized participants who took at least 1 dose of test article, and had data available at least for 5 of 7 days at screening and 20 days for at least 1 post-baseline interval. n=participants evaluable at specified time periods for each arm, respectively.||percentage of days||Standard Error|Mean
714702|NCT00242710|Primary|Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at Month 12|BMD measurements of the total hip were acquired by DXA, twice at Month 12 in participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. An average of the 2 readings was reported.|Baseline, Month 12|MITT population for BMD of total hip included all randomized participants who took at least 1 dose of test article, and had a baseline and at least 1 on-therapy evaluation of BMD (scans acquired more than 60 days after the test article administration was stopped were excluded) at Year 1. Missing values were imputed using LOCF method.||percent change||Standard Error|Least Squares Mean
714703|NCT00242710|Primary|Bone Mineral Density (BMD) of Total Hip at Screening|BMD measurements of the total hip were acquired by DXA, twice during screening in participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. An average of the 2 readings was reported.|Screening|MITT population for BMD of total hip included all randomized participants who took at least 1 dose of test article, and had a baseline and at least 1 on-therapy evaluation of BMD (scans acquired more than 60 days after the test article administration was stopped were excluded) at Year 1. Missing values were imputed using LOCF method.||g/cm^2||Standard Deviation|Mean
714704|NCT00242710|Primary|Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 12|BMD measurements of the anteroposterior lumbar spine were acquired by DXA, twice at Month 12 in participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. An average of the 2 readings was reported.|Baseline, Month 12|MITT population for BMD of lumber spine: all randomized participants who took at least 1 dose of test article, and had a baseline and at least 1 on-therapy evaluation of BMD (scans acquired more than 60 days after test article administration was stopped were excluded) at Year 1. Missing values imputed using last observation carried forward (LOCF).||percent change||Standard Error|Least Squares Mean
714705|NCT00242710|Primary|Bone Mineral Density (BMD) of Lumbar Spine at Screening|BMD measurements of the anteroposterior lumbar spine were acquired by dual-energy x-ray absorptiometry (DXA), twice during screening in participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. An average of the 2 readings was reported.|Screening|Modified intent-to-treat (MITT) population for BMD of lumber spine included all randomized participants took at least 1 dose of test article, and had a baseline and at least 1 on-therapy evaluation of BMD (scans acquired more than 60 days after the test article administration was stopped were excluded) at Year 1.||grams per square centimeter (g/cm^2)||Standard Deviation|Mean
714706|NCT00242710|Primary|Percentage of Participants With Hyperplasia at Month 12|Endometrial hyperplasia was assessed by endometrial biopsies. All endometrial biopsies were read centrally by 2 primary pathologists. Participants were considered to have a diagnosis of hyperplasia if both pathologists read hyperplasia (simple hyperplasia with or without atypia or complex hyperplasia with or without atypia). If the both pathologists disagreed on the presence of hyperplasia, a third pathologist was consulted, with the final diagnosis determined by the majority opinion.|Month 12|Efficacy evaluable (EE) analysis population for Year 1: all participants who were randomized and took at least 1 dose of test article, who had a screening endometrial biopsy with readings by at least 2 blinded central pathologists, had a biopsy during Month 12, or had hyperplasia diagnosed before Month 12 and had no major protocol violations.||percentage of participants||95% Confidence Interval|Number
714707|NCT00242710|Primary|Percentage of Participants With Hyperplasia at Screening|Endometrial hyperplasia was assessed by endometrial biopsies. All endometrial biopsies were read centrally by 2 primary pathologists. Participants were considered to have a diagnosis of hyperplasia if both pathologists read hyperplasia (simple hyperplasia with or without atypia or complex hyperplasia with or without atypia). If the both pathologists disagreed on the presence of hyperplasia, a third pathologist was consulted, with the final diagnosis determined by the majority opinion.|Screening|Endometrial hyperplasia at screening was an exclusion criterion and participants who had hyperplasia were not included in the analysis. Therefore this data is not available.|||||
714708|NCT00243022|Secondary|Food Intake as Assessed by the Block 98 Food Frequency Questionnaire and a 3-day Food Record|The 3-day food diary will be used to assess the dietary intake and to increase eating awareness of patients.|At 2, 4, 6, 12, and 24 months||||||
714732|NCT00243074|Secondary|Overall Survival|From the date of enrollment until the date of death due to any cause. Patients last known to be alive were censored at the date of last contact.|Daily during protocol treatment; then every 8 weeks until progression; then every 6 months for up to 3 years.|Eligible patients who received AZD2171||months||95% Confidence Interval|Median
714710|NCT00243022|Secondary|Time-to-tumor-progression: Percentage of Patients With Tumor Progression at 1 Year|Percentage of participants with tumor progression (>25% increase in tumor volume compared to time 0) will be measured from enrollment to documented progression or death whichever comes first. The method used to calculate the time to tumor progression was Kaplan Meier test method to define the 95% confidence levels.|1 year|All 12 patients followed to progression or death, or censored at last visit when known alive||percentage of participants||95% Confidence Interval|Number
714711|NCT00243022|Secondary|Time-to-tumor-progression: Percentage of Patients With Tumor Progression at 6 Months|Percentage of participants with tumor progression (>25% increase in tumor volume compared to time 0) will be measured from enrollment to documented progression or death whichever comes first. The method used to calculate the time to tumor progression was Kaplan Meier test method to define the 95% confidence levels.|6 months|All 12 patients followed to progression or death, or censored at last visit when known alive||percentage of participants||95% Confidence Interval|Number
714712|NCT00243022|Secondary|Quality of Life at 6 Months|Quality of life as assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 Items (EORTC QLQ-C30)|At 2, 4, 6, 12, and 24 months|At baseline and the most recent post treatment point in time, the QOL data for group 1 consist of n=3 patients and for group 2, n=2. Because of low patient numbers, no analysis was done.|||||
714713|NCT00243022|Primary|Change From Baseline in Peritumoral Brain Edema|The relative change from baseline will be assessed longitudinally, however, the main comparison of interest is the relative change at the 4-month evaluation. For each patient change = edema at follow up – baseline edema.|at 6 months|Patients with baseline and follow up peritumoral edema measurement. Closest measurement to time point was used. When 4 month was not available last prior was used.||cm^3||Standard Deviation|Mean
714714|NCT00243022|Primary|Change From Baseline in Peritumoral Brain Edema|The relative change from baseline will be assessed longitudinally, however, the main comparison of interest is the relative change at the 4-month evaluation.For each patient change = edema at follow up – baseline edema.|at 4 months|Patients with baseline and follow up peritumoral edema measurement. Closest measurement to time point was used. When 4 month was not available last prior was used.||cm^3||Standard Deviation|Mean
714715|NCT00243022|Primary|Change From Pooled Baseline in Peritumoral Brain Edema|The relative change from baseline will be assessed longitudinally, however, the main comparison of interest is the relative change at the 4-month evaluation. For each patient change = edema at follow up – baseline edema|at 2 months|Patients with baseline and follow up peritumoral edema measurement. Closest measurement to time point was used. When 4 month was not available last prior was used.||cm^3||Standard Deviation|Mean
714716|NCT00243061|Secondary|Change in Vessel Permeability and Blood Flow by DCE-MRI||From baseline to up to 28 days after starting daily oral dosing||||||
714717|NCT00243061|Secondary|Changes in Levels of Soluble Angiogenic Factors||From baseline to up to 6 years||||||
714718|NCT00243061|Secondary|Clinical Benefit Response||Up to 6 years||||||
714719|NCT00243061|Secondary|Time to Disease Progression||Up to 6 years|9 patients developed progressive disease||months||95% Confidence Interval|Median
714720|NCT00243061|Secondary|Toxicity as Assessed by NCI CTCAE Version 3.0||Up to 6 years after completion of treatment||||||
714721|NCT00243061|Secondary|Stable Disease Duration||From the start of the treatment until the criteria for progression are met, assessed up to 6 years||||||
714722|NCT00243061|Secondary|Response Duration||From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 6 years|||months|||Number
714723|NCT00243061|Secondary|Survival Rate||At 1 year|||percentage of participants||95% Confidence Interval|Number
714724|NCT00243061|Secondary|Median Survival Time||Up to 6 years|||months||95% Confidence Interval|Median
714725|NCT00243061|Primary|Prolonged Stable Disease According to RECIST||Up to 6 months|||participants|||Number
714726|NCT00243061|Primary|Objective Tumor Response (Partial or Complete Response) According to RECIST|"Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [J Nat Cancer Inst 92(3):205-216, 2000]. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions, assessed by CT or MRI; Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|Up to 6 years|Out of 24 patients analyzed, 0 patients had objective response of PR or CR as defined by RECIST||participants|||Number
714727|NCT00243074|Secondary|Adverse Events|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Patients were assessed for adverse events every day for as long as they remained on protocol treatment, up to 5 years.|Eligible patients who received any amount of protocol treatment with AZD2171 (cediranib maleate)||Participants|||Number
714728|NCT00243074|Secondary|Adverse Event Rates|Adverse events per the NCI Common Toxicity Criteria version 3.0 that were possibly, probably or definitely related to protocol treatment.|Daily during protocol treatment||||||
714729|NCT00243074|Secondary|Objective Response Rate Per Modified RECIST for Pleural Tumors|The sum of 6 pleural thickness measurements is added to sum of the longest diameters of all non-pleural measurable lesions. The resulting values are evaluated using RECIST.|Disease assessments for response were performed every 8 weeks as long as the patient remained on protocol treatment, up to 5 years.|Eligible patients who received any amount of AZD2171||percentage of participants||95% Confidence Interval|Number
714730|NCT00243074|Secondary|Disease Control Rate|The percentage of patients with a best of response of stable disease or better per standard RECIST. That is, patients whose best response was not increasing disease or death.|Every 8 weeks until disease progression progression, up to 5 years.|Eligible patients who received AZD2171||percentage of participants||95% Confidence Interval|Number
714731|NCT00243074|Secondary|Progression-free Survival|From the date of enrollment until the date of disease progression (as determined by standard RECIST), symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free were censored at the date of last contact. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Every 8 weeks until disease progression or death, up to 5 years.|Eligible patients who received AZD2171||months||95% Confidence Interval|Median
714733|NCT00243074|Primary|Overall Response Rate|"confirmed complete and partial responses per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.."|Disease assessments for response were performed every 8 weeks for as long as the patient remained on protocol treatment, up to 5 years.|Eligible patients who received any amount of AZD2171||percentage of participants||95% Confidence Interval|Number
714734|NCT00243191|Primary|To Collect Matched Tumor Tissue of Trial Participants With Dermatofibrosarcoma Protuberans Before and After Treatment With Imatinib for Future Use in cDNA Microarray and Tissue Array Studies.|To obtain matched tumor tissue samples of trial participants dermatofibrosarcoma protuberans (DFSP)for the purpose of determining whether imatinib mesylate affects autocrine/paracrine stimulated signal transduction through the platelet-derived growth factor receptor pathway in DFSP by comparing the level of phosphorylated platelet-derived growth factor receptor beta (PDGFRB) in DFSP after up to 2 weeks of treatment with imatinib to the level of phosphorylated PDGFRB pre-treatment.|Prior to and after 2-weeks of imatinib therapy|Population of paired tissue samples collected from patients with confirmed diagnosis of dermatofibrosarcoma protuberans. Tissue sample will be considered evaluable if there is adequate pre-treatment and on-treatment tumor tissue available for the proposed molecular studies, and resection of DFSP was completed after receiving imatinib.||paired tumor tissue samples|||Number
714735|NCT00243243|Primary|Total Number of Blood Components Transfused During and up to 24 Hours Post Operatively||24 hours|||units of blood components|||Number
714736|NCT00243269|Secondary|Health Related Quality of Life|Health-Related Quality of Life was assessed using the Functional Assessment of Cancer Therapy Scale – General (FACT–G). The FACT–G is a 28-item scale developed specifically for use in cancer clinical trials. Possible scores range from a low of 0 to a high of 112. Along with a total score representing HRQL, there are psychometrically validated subscales of physical, functional, social, and cognitive-emotional status. It has become one of the most commonly used measures in oncology, and we have used this scale in our previous studies.|5 days|||Units on scale||Standard Deviation|Mean
714737|NCT00243269|Primary|Five-day Nausea Diary|"Nausea was measured using a five-day patient report diary. Each day was divided into 4 sections: morning, afternoon, evening, and night. Patients reported severity of nausea for each period daily. Severity of nausea was assessed on a 7-point rating scale, anchored at one end by 1 = “Not at all nauseated and at the other end by 7 = Extremely nauseated. The description “Moderately nauseated” was centered on the scale below the 4. Average Nausea was the mean severity for the 20 reporting periods."|Five days|All patients who did not have protocol violations who provided evaluable data were included in the analyses. No data imputation was used.||Units on scale||Standard Deviation|Mean
714738|NCT00243347|Secondary|Change From Baseline in Mean Arterial Blood Pressure (MAP)|Change from baseline in mean arterial blood pressure (MAP) (MAP value at Day 22 – MAP value at baseline).|Randomisation until Day 22|Of the 19 patients, only 17 patients were evaluable MAP analysis. To be evaluable for MAP analysis, patients had to have MAP data collected at Day 1 and at least one post-baseline visit.||mmHg||95% Confidence Interval|Mean
714739|NCT00243347|Primary|Change From Baseline in Standardised Uptake Value (SUVmax) as Measured by 2-[F-18]-Fluoro-2-deoxy-D-glucose Positron Emission Tomography (FDG-PET)|Percentage Change from baseline in Standardised Uptake Value (SUVmax) at Day 22, as Measured by 2-[F-18]-fluoro-2-deoxy-D-glucose positron emission tomography (FDG-PET) Response ((Day 22 SUVmax value – baseline SUVmax value)/baseline SUVmax value)*100|Randomisation until Day 22|Of the 19 patients, only 17 patients were evaluable for FDG-PET analysis. To be evaluable for FDG-PET, patients had to have FDG-PET data collected at Day 1 and at least one post-baseline visit.||Percentage change in SUVmax||95% Confidence Interval|Geometric Mean
714740|NCT00243386|Post-Hoc|Median (IQR) Annualized Bleed Rates|Bleed rates (number of bleeding episodes per subject) were annualized to account for the varying number of days a subject may have actually been on each regimen.|On-demand 6 months (± 2 weeks); Prophylaxis 12 months (± 2 weeks)|Per-Protocol Efficacy Analysis Set||Bleeding episodes||Inter-Quartile Range|Median
714741|NCT00243386|Secondary|Physical Component Scores (PCS) HRQoL Scores Change From On-Demand Period Through Prophylaxis Period|"Change = (End of on-demand treatment) – (End of prophylaxis regimen) A negative value for the median difference equates to a larger domain score for the prophylaxis regimen.
Scores range 0-100, higher scores represent better health. There is no total overall score; scoring is done for subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores."|End of on-demand treatment period (6 months) and at study termination (approximately 18 months)|Pharmacoeconomic analysis set for participants ≥14 years of age||Scores on a scale||Full Range|Median
714742|NCT00243386|Secondary|Bodily Pain HRQoL Scores Change From On-Demand Period Through Prophylaxis Period|"Change = (End of on-demand treatment) – (End of prophylaxis regimen). A negative value for the median difference equates to a larger domain score for the prophylaxis regimen.
Scores range 0-100, higher scores represent better health. There is no total overall score; scoring is done for subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores."|End of on-demand treatment period (6 months) and at study termination (approximately 18 months)|Pharmacoeconomic analysis set for participants ≥14 years of age||Scores on a scale||Full Range|Median
714743|NCT00243386|Primary|Median Annualized Bleed Rate Estimates From Each of the 1 Year Prophylaxis Regimens|"Participants were Randomized to Receive 1 of the 2 Following Prophylaxis Regimens (Part 2 of the study):
Standard prophylaxis- infusions every 48 ±6 hours, dosed at 20 to 40 IU/kg.
PK-driven prophylaxis- infusions every 72 ±6 hours dosed at 20 to 80 IU/kg."|12 months ±2 weeks|Intent to treat||Bleeds per year||Full Range|Median
714762|NCT00243386|Secondary|Assessment of Hemostasis for Treatment of Bleeding Episodes|"Number of rAHF-PFM-treated bleeding episodes with an assessment of hemostasis (4-point ordinal scale):
Excellent: Full pain relief & bleeding cessation within ~8 hrs of 1 infusion. Additional infusions may have been given to maintain hemostasis;
Good: Definite pain relief and/or improvement in bleeding within ~8 hrs after infusion. Possibly requires >1 infusion for complete resolution;
Fair: Probable or slight relief of pain & slight improvement in bleeding within
~8 hrs after infusion. Requires >1 infusion for complete resolution;
None: No improvement or condition worsens"|On-demand 6 months (± 2 weeks); Prophylaxis 12 months (± 2 weeks)|Hemostatic Efficacy Rating Analysis Set (Participants with bleeding episodes that were rated)||bleeding episodes|||Number
714744|NCT00243386|Secondary|HRQoL Scores Change From On-Demand Treatment Regimen Period Through Prophylaxis Period|"Differences in health domain scores = (End of on-demand treatment) – (End of prophylaxis regimen). A negative value for the median difference equates to a larger domain score for the prophylaxis regimen
Physical Functioning (PF); Role Limitation Due to Physical Health (RP); Bodily Pain (BP); General Health (GH); Vitality (VT); Social Functioning (SF); Role Limitation Due to Emotional Problems (RE); Mental Health (MH), Physical Component Score (PCS); Mental Component Score (MCS).
Scores range 0-100, higher scores represent better health. There is no total overall score; scoring is done for subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores."|End of on-demand treatment period (6 months) and at study termination (approximately 18 months)|Pharmacoeconomic Analysis Set ≥14 Years and Older||Scores on a scale||Full Range|Median
714745|NCT00243386|Secondary|Health-related Quality of Life (HRQoL) Scores: PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS at the End of Treatment Regimens|Physical Functioning (PF); Role Limitation Due to Physical Health (RP); Bodily Pain (BP); General Health (GH); Vitality (VT); Social Functioning (SF); Role Limitation Due to Emotional Problems (RE); Mental Health (MH), Physical Component Score (PCS); Mental Component Score (MCS). Baseline SF-36v1 Scores, where data available. Scores range 0-100, higher scores represent better health. There is no total overall score; scoring is done for subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores.|End of on-demand treatment period (6 months) and at study termination (approximately 18 months)|Pharmacoeconomic Analysis Set||Scores on a scale||Full Range|Median
714746|NCT00243386|Secondary|Baseline Health-related Quality of Life (HRQoL) Scores: PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS|Physical Functioning (PF); Role Limitation Due to Physical Health (RP); Bodily Pain (BP); General Health (GH); Vitality (VT); Social Functioning (SF); Role Limitation Due to Emotional Problems (RE); Mental Health (MH), Physical Component Score (PCS); Mental Component Score (MCS). Baseline SF-36v1 Scores, where data available. Scores range 0-100, higher scores represent better health. There is no total overall score; scoring is done for subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores.|Baseline|Safety Analysis Set||Scores on a scale||Full Range|Median
714747|NCT00243386|Secondary|Number of Participants With Severe SAEs and Severe Non-SAEs by Preferred MedDRA Term and Treatment Regimen|This outcome is focused only on SEVERE SAEs and SEVERE non-SAEs|Throughout the study period (4 years and 5 months)|Safety Analysis Set||participants|||Number
714748|NCT00243386|Secondary|AEs With Onset ≤1 Hour Following the End of an Infusion, Regardless of Relatedness||Throughout study period (4 years and 5 months)|Safety Analysis Set||Events|||Number
714749|NCT00243386|Secondary|Number of Participants With SAEs by Preferred MedDRA Term and Treatment Regimen||Throughout the study period (4 years and 5 months)|Safety Analysis Set||participants|||Number
714750|NCT00243386|Secondary|Number of Participants Who Reported ≥1 AE Regardless of Relatedness to IP by Treatment Regimen||Throughout the study period (4 years and 5 months)|Safety Analysis Set||participants|||Number
714751|NCT00243386|Secondary|Number of Participants Who Reported ≥1 AE Regardless of Relatedness to Investigational Product (IP)|Number of treated participants with 1 or more AE regardless of relatedness to IP|Throughout study period (4 years and 5 months)|Safety Analysis Set||Participants|||Number
714752|NCT00243386|Secondary|Number of Participants With AEs Related to Investigational Product (IP)|Number of treated participants with AEs judged to be possibly or probably related to treatment with IP|Throughout study period (4 years and 5 months)|Safety Analysis Set||Participants|||Number
714753|NCT00243386|Secondary|Factor VIII Inhibitor Development|Number of treated participants who developed factor VIII inhibitors|Throughout study period (4 years and 5 months)|Safety Analysis Set||Participants|||Number
714754|NCT00243386|Secondary|Volume of Distribution at Steady State|Computed as weight-adjusted clearance * mean residence time|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Intent to Treat Pharmacokinetic Analysis Set||dL/kg||Standard Deviation|Mean
714755|NCT00243386|Secondary|Mean Residence Time|Computed as total Area Under the Moment Curve (AUMC) divided by the total AUC|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Intent to Treat Pharmacokinetic Analysis Set||hours||Standard Deviation|Mean
714756|NCT00243386|Secondary|Weight-Adjusted Clearance|Computed as the weight-adjusted dose divided by total AUC|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Intent to Treat Pharmacokinetic Analysis Set||mL/(kg*h)||Standard Deviation|Mean
714757|NCT00243386|Secondary|Terminal Half-life|Computed from the regression slope in the terminal phase of the model. Terminal half life is the time it takes for the plasma concentration or the amount of drug in the body to be reduced by 50%.|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Intent to Treat Pharmacokinetic Analysis Set||hours||Standard Deviation|Mean
714758|NCT00243386|Secondary|Adjusted Incremental Recovery (IR)|"Change in factor VIII concentration from pre- to post-infusion at initial and termination study visits.
Adjusted IR defined as:
[Cmax (IU/dL) – pre-infusion FVIII (IU/dL)]/dose (IU/kg)"|30 minutes pre-infusion to 48 hours post-infusion|Intent to Treat Pharmacokinetic Analysis Set||IU/dL per IU/kg||Standard Deviation|Geometric Mean
714759|NCT00243386|Secondary|Maximum Plasma Concentration (C-max)|Maximal Factor VIII Concentration After Infusion|Within 1 hour post-infusion|Intent to Treat Pharmacokinetic Analysis Set||IU/dL||Standard Deviation|Geometric Mean
714760|NCT00243386|Secondary|Area Under the Curve|Area under the factor VIII (FVIII) plasma concentration versus time curve (AUC) from 0 to 48 hours estimated using the linear trapezoidal method|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Intent to Treat Pharmacokinetic Analysis Set||IU*h/dL||Standard Deviation|Geometric Mean
714761|NCT00243386|Secondary|Total Area Under the Curve (AUC)|Total AUC estimated by AUC 0-48h plus an area extrapolated from the log-linear regression model|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Intent to Treat Pharmacokinetic Analysis Set||IU*h/dL||Standard Deviation|Geometric Mean
714763|NCT00243386|Secondary|Bleeding Episodes Treated With 1 to ≥4 Infusions|The number of bleeding episodes treated with 1, 2, 3, or ≥4 infusions of rAHF-PFM to achieve adequate hemostasis|Throughout the study period (4 years and 5 months)|Intent to Treat Efficacy Set||Bleeding episodes|||Number
714764|NCT00243386|Secondary|Total Weight-Adjusted Dose of rAHF-PFM Used Per Year for Each Prophylaxis Arm|"Participants were Randomized to Receive 1 of the 2 Following Prophylaxis Regimens (Part 2 of the study):
Standard prophylaxis- infusions every 48 ±6 hours, dosed at 20 to 40 IU/kg.
PK-driven prophylaxis- infusions every 72 ±6 hours dosed at 20 to 80 IU/kg."|12 months ±2 weeks|Intent to treat||IU/kg||Inter-Quartile Range|Median
714765|NCT00243386|Secondary|Mean Difference of Transformed Annualized Bleeding Rate Between On-Demand and Any Prophylaxis Treatment Regimens|"Annualized bleed rates were transformed using the square root of the number of bleeding episodes observed (X bleeds/year), X′ = √(X + 0.5). This transformation was performed to stabilize the variance and align the sample distribution with the assumption of normality inherent in using the paired t-test.
Mean Difference of Transformed Annualized Bleeding Rate (TABR) = (On-Demand Treatment TABR) - (Any Prophylaxis Treatment TABR).
Any Prophylaxis = Standard or PK-Driven Prophylaxis
Participants from the On-Demand portion of the study were subsequently randomized to either Standard Prophylaxis or PK-Driven Prophylaxis, (i.e the same participants were analyzed across the two measurement time periods)."|On-demand 6 months (± 2 weeks); Prophylaxis 12 months (± 2 weeks)|Intent to treat||(bleeds/year)^(1/2)||Standard Deviation|Mean
714766|NCT00243386|Secondary|Mean Difference of Transformed Annualized Bleeding Rate Between On-Demand and PK-Driven Prophylaxis Treatment Regimens|"Annualized bleed rates were transformed using the square root of the number of bleeding episodes observed (X bleeds/year), X′ = √(X + 0.5). This transformation was performed to stabilize the variance and align the sample distribution with the assumption of normality inherent in using the paired t-test.
Mean Difference of Transformed Annualized Bleeding Rate (TABR) = (On-Demand Treatment TABR) - (PK-Driven Prophylaxis Treatment TABR)
Participants from the On-Demand portion of the study were subsequently randomized to either Standard Prophylaxis or PK-Driven Prophylaxis, (i.e the same participants were analyzed across the two measurement time periods)."|On-demand 6 months (± 2 weeks); followed by Prophylaxis 12 months (± 2 weeks)|Intent to treat||(bleeds/year)^(1/2)||Standard Deviation|Mean
714767|NCT00243386|Secondary|Mean Difference of Transformed Annualized Bleeding Rate Between On-Demand and Standard Prophylaxis Treatment Regimens|"Annualized bleed rates were transformed using the square root of the number of bleeding episodes observed (X bleeds/year), X′ = √(X + 0.5). This transformation was performed to stabilize the variance and align the sample distribution with the assumption of normality inherent in using the paired t-test.
Mean Difference of Transformed Annualized Bleeding Rate (TABR) = (On-Demand Treatment TABR) - (Standard Prophylaxis Treatment TABR).
Participants from the On-Demand portion of the study were subsequently randomized to either Standard Prophylaxis or PK-Driven Prophylaxis, (i.e the same participants were analyzed across the two measurement time periods)."|On-demand 6 months (± 2 weeks); followed by Prophylaxis 12 months (± 2 weeks)|Intent to treat||(bleeds/year)^(1/2)||Standard Deviation|Mean
714768|NCT00243386|Primary|Mean Transformed Annualized Bleed Rate Estimates From Each of the 1-year Prophylaxis Regimens|"Participants were Randomized to Receive 1 of the 2 Following Prophylaxis Regimens (Study Part 2):
Standard prophylaxis (20-40 IU/kg (every 48 ±6 hour), exact regimen determined by investigator)
PK-driven prophylaxis (20-80 IU/kg (every 72 ±6 hour), exact regimen determined by sponsor)
Annualized bleed rates were transformed using the square root of the number of bleeding episodes observed (X = bleeds/year), X′ = √(X + 0.5). This transformation was performed to stabilize the variance and align the sample distribution with the assumption of normality inherent in using the t-test."|12 months ±2 weeks|Per Protocol||(bleeds/year)^(1/2)||Standard Deviation|Mean
714769|NCT00243412|Secondary|Change From Baseline in Cyclic Citrullinated Peptide (CCP) Antibodies/Cytokines|Because of the different laboratory methods that were used to measure anti-CCP antibody levels, no summary statistics were calculated.|Baseline, 24 Months|||units|||Number
714770|NCT00243412|Secondary|Change From Baseline in Rheumatoid Factor (RF)|Serum levels of rheumatoid factor at baseline, month 24 and change from baseline to month 24.|Baseline, 24 Months|Participants from the Safety-Evaluable population for whom data was available at baseline and month 24.||IU/mL||Standard Deviation|Mean
714771|NCT00243412|Secondary|DAS28-4 Erythrocyte Sedimentation Rate(ESR)|The DAS28-4(ESR) score is a measure of the subject’s disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient’s global assessment of disease activity (mm), and ESR. DAS28-4(ESR) scores range from 0 - 10, where a score of less than or equal to 3.2 implies well controlled disease and greater than or equal to 5.1 implies active disease In this trial, CRP rather than ESR was used, unless the CRP value was missing at both Day 1 and screening, in which case ESR value was used.|24 Months|Participants from the Intent−to−Treat (ITT) for whom data was available at baseline and month 24.||Scores on a scale||Standard Deviation|Mean
714772|NCT00243412|Secondary|Change From Baseline in Functional Assessment for Chronic Illness Therapy–Fatigue (FACIT-F)|FACIT-F is a 13-item questionnaire. Patients scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the patient’s response to the questions (with the exception of 2 negatively stated), the greater the patient’s fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the patient’s response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the patient’s health status.|Baseline, 24 Months|Participants from the Intent−to−Treat (ITT) population for whom data was available at baseline and month 24.||Scores on a scale||Standard Deviation|Mean
714773|NCT00243412|Secondary|Change From Baseline in Health Assessment Questionnaire–Disability Index (HAQ-DI)|The Stanford HAQ-DI is a patient-reported questionnaire specific for RA. It consists of 20 questions referring to eight component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. The questionnaire was provided in a certified translation of the local languages at the participating sites and was scored based on the instructions from the Stanford University Medical Center.The questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Higher scores= greater dysfunction.|Baseline, 24 Months|Participants from the Intent−to−Treat (ITT) population for whom data was available at baseline and month 24.||Scores on a scale||Standard Deviation|Mean
714785|NCT00243503|Secondary|Probability of Survival at One Year|One- year survival probability was estimated using the Kaplan-Meier method.|From start of study treatment until death or 2 years from first study treatment|The ITT population included all enrolled participants who were treated with the combination (trastuzumab and sunitinib).||percentage of 1-year survival||95% Confidence Interval|Number
714774|NCT00243412|Secondary|Change From Baseline in Short Form 36 (SF 36) Summary and Subscale Scores|The SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning (PF), Role Physical (RP), Bodily Pain(BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE),Mental Health (MH). Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score.|Baseline, 24 Months|Participants from the Intent−to−Treat (ITT) for whom data was available at baseline and month 24.||Units on a Scale||Standard Deviation|Mean
714775|NCT00243412|Secondary|Number of Participants With European League Against Rheumatism (EULAR) Response and Remission Using Disease Activity Score 28–4 (DAS28-4)C-reactive Protein (CRP)|"EULAR remission = DAS28-4(CRP) < 2.6 (Fransen et al. 2004.
EULAR response categories (van Gestel et al. 1999):
Good response = final DAS28-4(CRP) < 3.2 and decreased > 1.2 points from baseline Moderate response = final DAS28-4(CRP) ≥ 3.2 but ≤ 5.1 and decreased > 0.6 points from baseline or final DAS28-4(CRP) > 5.1 and decreased > 1.2 from baseline."|Baseline, 24 months|Participants from the Intent−to−Treat (ITT) population for whom data was available at baseline and month 24.||Participants|||Number
714776|NCT00243412|Secondary|Number of Participants With American College of Rheumatology (ACR) Major Clinical Response and/or Remission|"Major clinical response is an ACR70 response defined as improvement from baseline: ≥70% in tender joint count; ≥70% in swollen joint count; ≥70% in 3 of the following: Patient Pain Assessment, Patient Global Assessment, Physician Global Assessment, Patient Self-Assessed Disability, ESR or CRP for ≥169 consecutive days.
Remission: ≥5 requirements fulfilled for ≥2 consecutive months: Duration of morning stiffness <15 minutes, No fatigue, No joint pain, No joint tenderness or pain on motion, No soft tissue swelling in joints or tendon sheaths, ESR <30 mm/hour for women and <20 mm/hour for men."|24 months|Intent−to−Treat (ITT)||Participants|||Number
714777|NCT00243412|Secondary|Number of Participants With American College of Rheumatology Responses (ACR20, ACR50, and ACR70)|"ACR20 response was defined as satisfying the following 3 criteria improvement from baseline: ≥ 20% in tender joint count; ≥ 20% in swollen joint count; ≥ 20% improvement from baseline in 3 of the following 5 criteria:
Subject’s Global Assessment of Pain Subject’s Global Assessment of Disease Activity Physician’s Global Assessment Subject’s Self-Assessment Erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP) Note: The definitions of ACR50 and ACR70 are the same as ACR20, except that the 20% value in the above definition is replaced by 50% and 70% values, respectively."|Baseline, 24 months|Intent−to−Treat (ITT)||Participants|||Number
714778|NCT00243412|Secondary|Change From Baseline in Disease Activity Score 28-4 C-reactive Protein (DAS28-4(CRP))|The DAS28-4(CRP) score is a measure of the subject’s disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient’s global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity. Change from baseline at 24 months was analyzed for DAS28-4 (CRP).|Baseline, 24 months|Participants from the Intent−to−Treat (ITT) population for whom data was available at baseline and month 24.||Scores on a scale||Standard Deviation|Mean
714779|NCT00243412|Primary|Number of Participants With Either an Infection or a Grade III or IV Adverse Event (National Cancer Institute Common Toxicity Criteria for Adverse Events [NCI CTCAE], Version 3.0)|"A Grade III Adverse Event (AE) is severe; defined as considerable interference with the subject’s daily activities, medical intervention/therapy required and hospitalization possible.
A Grade IV AE is life-threatening; defined as extreme limitation in activity, significant medical intervention/therapy required, hospitalization probable.
Because of the small sample size and the small number of subjects who completed Week 104, the analysis were limited to descriptive statistics only."|24 months|Safety−Evaluable Population||Participants|||Number
714780|NCT00243503|Secondary|Dose-corrected Ctrough of Total Drug (Sunitinib + SU-012662)|Ctrough = the concentration prior to study drug administration. Dose-corrected values were reported, the reference dose was 37.5 mg.|Predose on Day 1 of Cycle 3 and 5|The PK population included all enrolled participants who were treated with the combination (trastuzumab and sunitinib) and collected plasma values.||ng/mL||Standard Deviation|Mean
714781|NCT00243503|Secondary|Dose-corrected Ctrough of SU-012662 (Sunitinib's Metabolite)|Ctrough = the concentration prior to study drug administration. Dose-corrected values were reported, the reference dose was 37.5 mg.|Predose on Day 1 of Cycle 3 and 5|The PK population included all enrolled participants who were treated with the combination (trastuzumab and sunitinib) and collected plasma values.||ng/mL||Standard Deviation|Mean
714782|NCT00243503|Secondary|Dose-corrected Trough Plasma Concentrations (Ctrough) of Sunitinib|Ctrough = the concentration prior to study drug administration. Dose-corrected values were reported, the reference dose was 37.5 mg.|Predose on Day 1 of Cycle 3 and 5|The Pharmacokinetic (PK) population included all enrolled participants who were treated with the combination (trastuzumab and sunitinib) and collected plasma values.||nanograms (ng)/milliliter (mL)||Standard Deviation|Mean
714783|NCT00243503|Secondary|EORTC QLQ (BR23)|BR23: consisted of 23 questions which measured disease related symptoms of dry mouth, eye pain, hair loss, hot flushes, attractiveness, future health, sexual activity, arm/shoulder pain, breast pain, swollen breast, and skin problems on the breast. Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.|From start of treatment through 18 months|The ITT population included all enrolled participants who were treated with the combination (trastuzumab and sunitinib).The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.||scores on a scale||Standard Deviation|Mean
714784|NCT00243503|Secondary|EORTC QLQ-C30|EORTC QLQ-C30 scales consist of 30 questions: functional (physical/role/cognitive/emotional/ social), symptom (fatigue/nausea/vomiting/pain), global health/QOL, cancer symptom (dyspnea/insomnia/appetite loss/constipation/diarrhea). Feelings in past week: response range: not at all to very much, global/QOL range: very poor to excellent. Scales/single-items averaged, score 0 to 100. Higher functional/global=better functioning and symptom=greater degree of symptoms.|From start of treatment through 18 months|The ITT population included all enrolled participants who were treated with the combination (trastuzumab and sunitinib).The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.||scores on a scale||Standard Deviation|Mean
714786|NCT00243503|Secondary|Overall Survival (OS)|Time from first dose of study treatment to first documentation of death due to any cause. OS was calculated as (date of death minus first dose date +1) divided by 7 * 4.33.|From start of study treatment until death or 2 years from first study treatment|The ITT population included all enrolled participants who were treated with the combination (trastuzumab and sunitinib).||months||95% Confidence Interval|Median
714787|NCT00243503|Secondary|Time to Progression (TTP)|Time from first dose of study treatment to first documentation of objective tumor progression. If tumor progression data included more than 1 date, the first date was used. TTP was calculated as (first event date minus first dose date +1) divided by 7.|From start of treatment through 18 months|The ITT population included all enrolled participants who were treated with the combination (trastuzumab and sunitinib).||weeks||95% Confidence Interval|Median
714788|NCT00243503|Secondary|Progression Free Survival (PFS)|Time from first dose of study treatment to first documentation of objective tumor progression, or to death on-study due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. PFS was calculated as (first event date minus first dose date +1) divided by 7.|From start of treatment through 18 months|The ITT population included all enrolled participants who were treated with the combination (trastuzumab and sunitinib).||Weeks||95% Confidence Interval|Median
714789|NCT00243503|Secondary|Percentage of Participants With Clinical Benefit|Percent of participants with confirmed CR, PR or stable disease (SD) for at least 24 weeks on study according to RECIST.CR was defined as disappearance of all target and non-target lesions.PR was defined as >=30% decrease in sum of longest dimensions of target lesions taking as reference baseline sum longest dimensions associated to non-progressive disease response for non target lesions.SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference smallest sum of longest dimensions since treatment started.|From start of treatment through 18 months|The ITT population included all enrolled participants who were treated with the combination (trastuzumab and sunitinib).||Percentage of Participants||95% Confidence Interval|Number
714790|NCT00243503|Secondary|Duration of Response (DR)|Time from the first documentation of objective tumor response (CR or PR) that was subsequently confirmed to the first documentation of objective tumor progression or death due to any cause. If tumor progression data included more than 1 date, the first date was used. DR was calculated as (the end date for DR minus first CR or PR that was subsequently confirmed +1) divided by 7.|From start of treatment through 18 months|DR was calculated for the subgroup of participants from the ITT set, with a confirmed objective tumor response.||weeks||95% Confidence Interval|Median
714791|NCT00243503|Primary|Percentage of Participants With Overall Confirmed Objective Disease Response|Objective disease response =participants with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all target and non-target lesions. A PR was defined as a > = 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions associated to a non-progressive disease response for the non target lesions.|From start of treatment through 18 months|The intent-to-treat (ITT) population included all enrolled participants who were treated with the combination (trastuzumab and sunitinib).||percentage of participants||95% Confidence Interval|Number
714792|NCT00243659|Secondary|Number of Patients Who Achieved Hemostatic Efficacy at Hospital Discharge|Assessment of hemostatic efficacy by the investigator at the day of discharge from the hospital using the 4 point ordinal scale (Excellent, Good, Moderate or None). Excellent: Achieved hemostatic comparable to non-hemophilic patients. Good: Prolonged time to hemostasis (with somewhat increased bleeding compared to non-hemophilic patients.|6 weeks|The analysis population is the efficacy evaluable at visit five.||patients|||Number
714793|NCT00243659|Primary|Number of Patients Who Achieved Hemostatic Efficacy After Surgery|Efficacy at the end of surgery as determined by the investigator and/or the surgeon using the 4 point ordinal scale (Excellent, Good, Moderate or None). Excellent: Achieved hemostatic comparable to non-hemophilic patients. Good: Prolonged time to hemostasis (with somewhat increased bleeding compared to non-hemophilic patients.|6 weeks|The analysis population is the efficacy evaluable at visit three.||patients|||Number
714794|NCT00243919|Secondary|Activities Specific Balance Confidence (ABC) Score|Range = 0 - 100 The ABC scale is a self reported measure of confidence with activities such as walking around the house, standing on a chair to reach or getting out of a car without losing balance or becoming unsteady. A score of 0 indicates no confidence that the activities can be performed without losing balance and a score 100 indicates confidence that the activities can be accomplished without losing balance.|Baseline, 6 months and 12 months post-stroke|||units on a scale||Standard Deviation|Mean
714795|NCT00243919|Secondary|Berg Balance Score|Range = 0 - 56 The Berg Balance Score assesses balance in sitting, standing, reaching, shifting weight and turning, with 0 defined as inability to balance and 56 defined as the ability to balance independently and without difficulty while performing each task.|Baseline, 6 months and 12 months post-stroke|||units on a scale||Standard Deviation|Mean
714796|NCT00243919|Secondary|Fugl-Meyer Lower Extremity Score|Range 0 - 34 The Fugl-Meyer Lower Extremity Score measures your ability to move the lower extremity with 0 indicating no movement and 34 indicating the ability to selectively move the lower extremity without difficulty.|Baseline, 6 months and 12 months post-stroke|||units on a scale||Standard Deviation|Mean
714797|NCT00243919|Secondary|Stroke Impact Scale (SIS) - Mobility|Range = 0 - 100. The Stroke Impact Scale (SIS) is a measure of function including Mobility. The Mobility scale is a single domain of the Stroke Impact Scale which captures the ability to balance and move, with 0 indicating severe restrictions in balance and mobility and 100 indicating independence in mobility and balance.|Baseline, 6 months and 12 months post-stroke|||units on a scale||Standard Deviation|Mean
714798|NCT00243919|Secondary|Stroke Impact Scale (SIS) - Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL)|Range 0 - 100 The Stroke Impact Scale (SIS) is a measure of function including ADL/IADL. The ADL/IADL scale is a single domain of the Stroke Impact Scale in which ADL is defined as the ability to take care of basic needs and IADL is defined as the ability to perform activities that make it possible to live independently in the community, with 0 indicating complete dependence on others and 100 indicating the ability to live independently without difficulty.|Baseline, 6 months and 12 months post-stroke|||units on a scale||Standard Deviation|Mean
715008|NCT00247416|Secondary|Progression-free Survival|progression-free survival|Pre-treatment, pre-cycles 3 & 5,4 weeks after last treatment, and every 3 months, an average of 471 days|||days||95% Confidence Interval|Median
714799|NCT00243919|Secondary|Stroke Impact Scale (SIS) - Participation|Range = 0 - 100. The Stroke Impact Scale is a measure of function (including ADL–IADL and mobility) and quality of life (participation). The Participation Scale is a single domain of the Stroke Impact Scale in which participation is defined as the ability to engage in meaningful activities with 0 indicating inability to engage in any meaningful activities and 100 indicating the ability to fully engage in meaningful activities.|Baseline, 6 months and 12 months post-stroke|||units on a scale||Standard Deviation|Mean
714800|NCT00243919|Secondary|Step Activity Monitor (SAM)- Median of Average Number of Steps Per Day|As measured with a step activity monitor averaged over 2 days.|Baseline, 6 months and 12 months post-stroke|||steps||Inter-Quartile Range|Median
714801|NCT00243919|Secondary|6 Minute Walking Distance (Meters)|Distance walked in 6 minutes.|Baseline, 6 months and 12 months post-stroke|||meters||Standard Deviation|Mean
714802|NCT00243919|Secondary|6 Month Outcome: Walking Speed: Measured During a 10-meter Walk||Baseline and 6 months post-stroke|||m/sec||Standard Deviation|Mean
714803|NCT00243919|Secondary|Percentage of Patients Who Successfully Improved Functional Level of Walking at 6 Months Post-stroke|Success: walking greater than 0.4 m/sec if baseline was less than 0.4; walking greater than 0.8 m/sec if baseline was 0.4m/sec or greater but less than 0.8 m/sec as measured during 10 meter walk.|Baseline and 6 months post-stroke|Intention to treat analysis. Missing data were imputed using the Last Observation Carried Forward (LOCF) method.||percent of participants|||Number
714804|NCT00243919|Primary|Walking Speed: Measured During a 10-meter Walk||Baseline and 12 months post-stroke|||m/sec||Standard Deviation|Mean
714805|NCT00243919|Primary|Percentage of Patients Who Successfully Improved Functional Level of Walking at 1 Year Post-stroke|Success: walking greater than 0.4 m/sec if baseline was less than 0.4; walking greater than 0.8 m/sec if baseline was 0.4m/sec or greater but less than 0.8 m/sec as measured during 10 meter walk.|12 months post-stroke|Intention to treat analysis. Missing data were imputed using the LOCF method.||percent of participants|||Number
714806|NCT00243932|Primary|Change in the ALS Functional Rating Scale-revised (ALSFRSr) Score.|The ALSFRSr, a questionnaire-based scale assessing daily living function ranging from 48 (best score) to 0 (worst), was administered to the patient, or to a proxy if the patient could not communicate effectively. Decline was defined as ALSFRSr at baseline minus ALSFRSr at month 9. Thus a positive value indicates worsening.|9 months|||units on a scale||Standard Deviation|Mean
714807|NCT00243932|Secondary|The Change Over 9 Months in Forced Vital Capacity; Fatigue Severity Scale; Short Form-36; and 8OH2dG (a Biomarker of Oxidative Stress Measured in a Blood Sample).||9 months||||||
714808|NCT00244010|Primary|Treatment Failures|The primary objective of this study is to evaluate the safety of HAPLO HSCT for patients with refractory severe aplastic anemia (SAA) or refractory cytopenias. The treatment plan would be considered unsafe if we can demonstrate that it is associated with a significantly higher treatment failure rate. The treatment failure is defined as any occurrence of the following events, overall grade III-IV acute GVHD, graft failure or death due to any cause within 100 days post HSCT or after the last cellular product infusion, if required.|100 days post transplant|Enrollment was terminated due to the PI leaving the institution. Insufficient data was generated to answer the objective.|||||
714809|NCT00244101|Secondary|Parental Questionnaire for Health Status||at 24 months of age||||||
714810|NCT00244101|Secondary|Days in Hospital||prior to hospital discharge||||||
714811|NCT00244101|Secondary|Days of Ventilator Support||prior to hospital discharge||||||
714812|NCT00244101|Secondary|Complications of Prematurity||prior to hospital discharge||||||
714813|NCT00244101|Primary|Death||36 weeks adjusted age||||||
714814|NCT00244101|Primary|Death or Chronic Lung Disease||at 36 weeks postmenstrual age|intention to treat analysis||participants|||Number
714815|NCT00244140|Secondary|The Ability of the Blinded Readers to Make a Diagnosis Based on the CECT Images|The number of participants with diagnostic CECTs as assessed by the 3 blinded readers.|post administration assessment of study images|The primary efficacy analysis used the Full Analysis Set (FAS), which consisted of the subjects who received any amount of iopromide regardless of any protocol deviation, excluding the sample subjects and subjects who did not have CT images. In the FAS, 402 subjects were included.||Number of diagnostic CECTs|||Number
714816|NCT00244140|Secondary|The Quality of Visualization of the Contrast-Enhanced Computed Tomography (CECT) Images, Based on the Investigators' Assessment.|A subjective assessment of the 'Quality of Image' (QOI) by the investigators. QOI-Grades used: Excellent - Good - Poor.|post administration assessment of study images|The primary efficacy analysis used the Full Analysis Set (FAS), which consisted of the subjects who received any amount of iopromide regardless of any protocol deviation, excluding the sample subjects and subjects who did not have CT images. In the FAS, 402 subjects were included.||Number of participants in QOI grade|||Number
714817|NCT00244140|Secondary|The Ability of the Investigator to Make a Diagnosis Based on the CECT Images|The number of participants with diagnostic CECTs as assessed by the investigators.|post administration assessment of study images|The primary efficacy analysis used the Full Analysis Set (FAS), which consisted of the subjects who received any amount of iopromide regardless of any protocol deviation, excluding the sample subjects and subjects who did not have CT images. In the FAS, 402 subjects were included.||Number of diagnostic CECTs|||Number
714818|NCT00244140|Primary|The Quality of Visualization of the Contrast-Enhanced Computed Tomography (CECT) Images, Based on the Blinded Readers' Assessment.|A subjective assessment of the 'Quality of Image' (QOI) by 3 blinded readers (BR). QOI-Grades used: Excellent - Good - Poor.|post administration assessment of study images|The primary efficacy analysis used the Full Analysis Set (FAS), which consisted of the subjects who received any amount of iopromide regardless of any protocol deviation, excluding the sample subjects and subjects who did not have CT images. In the FAS, 402 subjects were included.||Number of participants in QOI grade|||Number
714819|NCT00231283|Secondary|Percentage of Participants Who Experienced Any Major Adverse Cardiac Events From Post-procedure to 12 Months Later|Major Adverse Cardiac Events (MACE) consists of death, Myocardial Infarction (Q-wave and Non Q-wave), emergent Coronary Artery Bypass Graft (CABG) or Target Lesion Revascularization (TLR).|From post-procedure up to 12 months|Patients who had at least 330 days clinical follow-up.||Percentage of participants|||Number
715009|NCT00247416|Secondary|Effect of Dexamethasone Pre-treatment on Overall Survival.|Overall survival|Pre-treatment, pre-cycles 3 & 5,4 weeks after last treatment, every 3 months, an average of 471 days|||days||95% Confidence Interval|Median
714820|NCT00231283|Secondary|Percentage of Participants Who Experienced Any Major Adverse Cardiac Events From Post-procedure to Hospital Discharge|Major Adverse Cardiac Events (MACE) consists of death, Myocardial Infarction (Q-wave and Non Q-wave), emergent Coronary Artery Bypass Graft (CABG) or Target Lesion Revascularization (TLR).|From post-procedure up to hospital discharge|Patients who were followed up to hospital discharge||Percentage of participants|||Number
714821|NCT00231283|Secondary|Percentage of Participants Who Experienced Any Major Adverse Cardiac Events From Post-procedure to 30 Days Later|Major Adverse Cardiac Events (MACE) consists of death, Myocardial Infarction (Q-wave and Non Q-wave), emergent Coronary Artery Bypass Graft (CABG) or Target Lesion Revascularization (TLR).|From post-procedure up to 30 days|Patients who had 30 days clinical follow-up.||Percentage of Participants|||Number
714822|NCT00231283|Primary|Percentage of Participants Who Achieved Procedure Success From Post-procedure to Hospital Discharge|Procedure Success is defined as the final residual diameter stenosis < 50 percent by Quantitative Coronary Angiography (QCA) using any percutaneous method, without the occurrence of death, Myocardial Infarction (MI), or repeat revascularization of the target lesion|From post-procedure up to hospital discharge|Patients who were followed up to hospital discharge||Percentage of Participants|||Number
714823|NCT00231309|Secondary|Hospital Length of Stay|hospital length of stay of each patient enrolled, an average of 5 weeks.|inpatient hospital stay|||average days||Standard Deviation|Median
714824|NCT00231309|Primary|Numbers of Participants With Disease-free Survival.|Evaluate the numbers of participants with disease-free survival|260 days|||participants|||Number
714825|NCT00231465|Secondary|Overall Survival (OS) Rate|OS was calculated from the date of enrollment to the date of death. All 44 treated were assessed for OS, with a minimum follow-up of 19 months.|Duration of time on study, an average of 19 months|All participants who initiated therapy between March 2003 and May 2005||Months||95% Confidence Interval|Median
714826|NCT00231465|Secondary|Progression Free Survival (PFS) Rate|PFS was calculated from the date of enrollment to the date of progression. All 44 treated were assessed for PFS, with a minimum follow-up of 19 months. Progression (PD): At least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Duration of time on study, an average of 19 months|All participants who initiated therapy between March 2003 and May 2005||Months||95% Confidence Interval|Median
714827|NCT00231465|Primary|Overall Response Rate (ORR)|ORR: Complete Response (CR) + Partial Response (PR). Response rate for Elderly (> 70 years) previously untreated patients with Stage IIIb (With Malignant Pleural Effusion (MPE)) or IV non-small cell lung cancer (NSCLC) receiving Taxotere + ZD1839. Best clinical response to treatment with combination was determined using Response Evaluation Criteria in Solid Tumors (RECIST V1.0): * Complete Response (CR)- Disappearance of all target lesions; * Partial Response (PR)- At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; * Progressive Disease (PD)- At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; * Stable Disease (SD)- Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Duration of time on study, an average of 19 months|Response was evaluable in 42 of the 44 patients.||percentage of participants||95% Confidence Interval|Mean
714828|NCT00231478|Secondary|Adverse Experiences|The adverse events are captured in the AE and SAE section of this database|infusion to 15 days post treatment|Eight of the 157 treated subjects (six and two in the 20- and 40-μg/kg dose groups,respectively) experienced a treatment-emergent serious adverse event up to 15 days after the treatment evaluation period.||number of participants|||Number
714829|NCT00231478|Secondary|Time to First Vomiting Episode|Time to first vomiting is described as the first event of emesis in hours. Subjects not having a vomiting episode are censored at the total length of time (in hours) between the time of extubation and time of the 24 hour follow-up.|0-24h after time of extubation|Evaluable Patients||hours||Standard Error|Mean
714830|NCT00231478|Secondary|Number of Patients With no Vomiting|No vomiting describes no emesis during the first 24 hours|0-24h after time of extubation|Evaluable Patients||participants|||Number
714831|NCT00231478|Primary|Number of Patients With no Vomiting|Number of patients with no vomiting is described as no emesis up to 2 hours after surgery|0-2h after end of surgery (time of extubation)|Evaluable Patients||participants|||Number
714832|NCT00231777|Secondary|Number of Patients With Serious CAEs|Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose|Baseline and 24 hours|All patients as treated (APaT) which included all patients who received active study therapy.||Participants|||Number
714833|NCT00231777|Secondary|Number of Patients With Drug-related CAEs|Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs|Baseline and 24 hours|All patients as treated (APaT) which included all patients who received active study therapy.||Participants|||Number
714834|NCT00231777|Primary|Number of Patients With Laboratory Adverse Experiences (LAEs)|A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product.|Baseline and 24 hours|"All patients as treated (APaT) which included all patients who received active study therapy.
patients in the MK0517 40 mg treatment group were randomized but did not have at least one post-baseline laboratory test and therefore were not counted as part of the N analyzed."||Participants|||Number
714835|NCT00231777|Primary|Number of Patients With Clinical Adverse Experiences (CAEs)|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|Baseline and 24 hours|All patients as treated (APaT) which included all patients who received active study therapy.||Participants|||Number
714850|NCT00245102|Primary|Overall Response Rate Measured by Complete Response (CR) Rate and Partial Response (PR) Rate as Determined by RECIST|A 5% response rate is considered not promising, a 20% response rate is considered promising. For each stratum, the response rate will be estimated and a confidence interval will be constructed.|Up to 4 weeks|||participants|||Number
714836|NCT00231816|Other Pre-specified|GMTs of B Strain Antibody Responses at 4 Weeks Postvaccination|GMT of the B strain antibody responses at 4 weeks postvaccination in participants who receive ZOSTAVAX™ concomitantly with influenza vaccine and those who receive ZOSTAVAX™ and influenza vaccine nonconcomitantly|4 weeks postvaccination|The analysis was based on the per protocol population defined as participants who had valid results from samples obtained within the prespecified day ranges at Day 1, at Week 4, or at Week 8 postvaccination, and who did not meet any of the protocol violations prespecified in the SAP||titers||95% Confidence Interval|Geometric Mean
714837|NCT00231816|Other Pre-specified|GMTs of H3N2 Strain Antibody Responses at 4 Weeks Postvaccination|GMT of the H3N2 strain antibody responses at 4 weeks postvaccination in participants who receive ZOSTAVAX™ concomitantly with influenza vaccine and those who receive ZOSTAVAX™ and influenza vaccine nonconcomitantly|4 weeks postvaccination|The analysis was based on the per protocol population defined as participants who had valid results from samples obtained within the prespecified day ranges at Day 1, at Week 4, or at Week 8 postvaccination, and who did not meet any of the protocol violations prespecified in the SAP.||titers||95% Confidence Interval|Geometric Mean
714838|NCT00231816|Other Pre-specified|Geometric Mean Titers (GMTs) of H1N1 Strain Antibody Responses at 4 Weeks Postvaccination|GMT of the H1N1 strain antibody responses at 4 weeks postvaccination in participants who receive ZOSTAVAX™ concomitantly with influenza vaccine and those who receive ZOSTAVAX™ and influenza vaccine nonconcomitantly|4 weeks postvaccination|The analysis was based on the per protocol population defined as participants who had valid results from samples obtained within the prespecified day ranges at Day 1, at Week 4, or at Week 8 postvaccination, and who did not meet any of the protocol violations prespecified in the SAP.||titers||95% Confidence Interval|Geometric Mean
714839|NCT00231816|Other Pre-specified|Geometric Mean Fold Rise (GMFR) in VZV gpELISA Antibody Titers From Prevaccination to 4 Weeks Postvaccination|"GMFR of the VZV gpELISA antibody titers from prevaccination
to 4 weeks postvaccination when ZOSTAVAX™ is administered concomitantly with influenza vaccine"|prevaccination to 4 weeks postvaccination|The analysis was based on the per protocol population defined as participants who had valid GMFR results from samples obtained within the prespecified day ranges at Day 1, at Week 4, or at Week 8 postvaccination, and who did not meet any of the protocol violations prespecified in the statistical analysis plan (SAP)||ratio||95% Confidence Interval|Geometric Mean
714840|NCT00231816|Primary|Varicella-zoster Virus (VZV) Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Antibody Responses|The Geometric mean titer (GMT) of the VZV glycoprotein enzyme-linked immunosorbent assay (gpELISA) antibody responses at Week 4 postvaccination in participants who received ZOSTAVAX™ concomitantly with influenza vaccine was compared to that in subjects who received influenza vaccine and ZOSTAVAX™ nonconcomitantly.|4 weeks|The primary analysis was based on the per protocol population defined as participants who had valid GMT results from samples obtained within the prespecified day ranges at Day 1, at Week 4, or at Week 8 postvaccination, and who did not meet any of the protocol violations prespecified in the statistical analysis plan (SAP).||gpELISA units/mL||95% Confidence Interval|Geometric Mean
714841|NCT00244374|Secondary|HIV Vaccine Trial Knowledge|"Participants were asked if they agreed or disagreed with or were unsure of each of eight statements about HIV vaccine trial concepts from the HIV Network for Prevention Trials (HIVNET).
Preventive HIV vaccine studies enroll people who are HIV-positive and HIV-negative.
Some participants in HIV vaccine studies will get a real vaccine, and some will get a placebo (an inactive substance).
Only vaccines known to be at least 50% effective at preventing HIV are tested in HIV vaccine studies.
Once a large scale HIV vaccine study begins, we can be sure the vaccine is completely safe.
Participants are told whether they got the HIV vaccine or the placebo at the end of HIV vaccine studies.
HIV vaccines will never affect a person's HIV test results.
An HIV vaccine can infect a person with HIV disease.
People in vaccine studies know whether or not they got the placebo because only the vaccines cause side effects."|Baseline|Per the Participant Flow, 409 participants in the cross-sectional study had complete and valid baseline data||Participants|||Number
714842|NCT00244374|Secondary|HIV Vaccine Trial Willingness|"We assessed knowledge about vaccine trials and willingness to participate in preventive HIV vaccine trials by asking the question: How willing would you be to join a study of a vaccine to prevent HIV infection, if the study were to start tomorrow?. Willingness was measured on a 4-point response scale, ranging from 1 (Definitely not willing) to 4 (Definitely willing)."|Baseline|Per the Participant Flow, 409 participants in the cross-sectional study had complete and valid baseline data||Participants|||Number
714843|NCT00244374|Secondary|Viral Transmission Risk Behavior Association With Travel|In a cross-sectional analysis of 355 subjects enrolled between 2004 and 2006, we estimate the associations between travel in the 3 months prior to baseline and behaviors occurring in the 30 days prior to baseline, such as drug and alcohol and sexual behaviors, that may facilitate the spread of viral infections.|Baseline|Cross-sectional analysis of 355 subjects enrolled between 2004 and 2006||percentage of participants|||Number
714844|NCT00244374|Secondary|Hepatitis B Surface Antibody Seroconversion After 3 Vaccine Doses|To examine the effect of hepatitis C virus (HCV) infection on vaccine effectiveness, we compared anti-HBs (antibody to the hepatitis B surface antigen) seroconversion after three vaccine doses between anti-HCV (antibody to the hepatitis C virus) positive and anti-HCV negative participants.|12 months|139 participants who completed 3 vaccine doses were included in the analysis. Enrollment for this aim continued after enrollment into the 12-month vaccine adherence trial closed; an additional 51 persons were found eligible and enrolled.||Participants|||Number
714845|NCT00244374|Primary|Vaccine Series Completion|The primary outcome was the completion of the four-dose vaccine series in a 12 month period.|12 months|||participants|||Number
714846|NCT00244621|Secondary|Change in Protein/Creatinine (P/C) Ratio for Each Assigned Dose Level From Baseline to Day 28||From randomisation to day 28|||Percent change||Inter-Quartile Range|Median
714847|NCT00244621|Secondary|Change in Albumin/Creatinine (A/C) Ratio for Each Assigned Dose Level From Baseline to Day 28||From randomisation to day 28|||Percent change||Inter-Quartile Range|Median
714848|NCT00244621|Secondary|Mean Change From Baseline to Week 4 in Diastolic Blood Pressure (DBP)||From randomisation to end of double-blind treatment (4 weeks)|||mm Hg||Standard Deviation|Mean
714849|NCT00244621|Primary|Mean Change From Baseline to Week 4 in Systolic Blood Pressure (SBP)||From randomisation to end of double-blind treatment (4 weeks)|||mm Hg||Standard Deviation|Mean
714851|NCT00245128|Secondary|Reduction in Marrow Fibrosis and Decrease in Spleen Size||After 6 and 12 months of therapy||||||
714852|NCT00245128|Primary|Percentage of Participants With Major and/or Minor Erythroid Responses at 3, 6, and 12 Months of Therapy|"A major response = transfusion independent or a>2.0g/dl rise in hemoglobin without transfusion maintained for at least 8 weeks.
Minor response= > 1 to 2.0g/dl incremental rise in hemoglobin maintained for at lease 8 weeks with a decrease in transfusion requirements of at least 50% compared to the mean transfusion requirement during the 8 week pre-study period."|At 3,6, and 12 months of therapy|||percentage of participants|||Number
714853|NCT00245219|Primary|Depressive Symptoms (as Measured With the CES-D) at Baseline, Time 2 (2 Weeks Post-intervention) and Time 3 (6 Months Post-intervention)|Scores for the shortened form of the Center for Epidemiologic Studies Depression scale(CES-D) ranged from 0 (no depressive symptoms) to 29 (high levels of depressives symptoms) in the present sample. For the sake of analyses, CES-D scores were dichotomized (cutoff score of 8), because scores exhibited marked positive skew in the present sample.|Baseline, Time 2 (2 Weeks post-intervention) and Time 3 (6 months post-intervention)|The intention-to-treat principle was followed, all participants were included in the analyses regardless of number of meetings attended.||units on a scale||Standard Deviation|Mean
714854|NCT00245219|Primary|Perceived Physical Health (as Measured With the SF36) at Baseline, Time 2 (2 Weeks Post-intervention) and Time 3 (6 Months Post-intervention)|The Perceived Physical Health Component scale of the Medical Outcomes Study Short Form 36(SF-36) consists of a norm-based weighted average of the following subscales: Physical Functioning, Bodily Pain, Role Limitations due to Physical Problems and General Health. In the present study, scores ranged from a maximum of 70 (high levels of perceived health) to a minimum of 12 (low levels of perceived health).|Baseline, Time 2 (2 weeks post-intervention) and Time 3 (6 months post-intervention)|The intention-to-treat principle was followed, all participants were included in the analyses regardless of number of meetings attended.||units on a scale||Standard Deviation|Mean
714855|NCT00245219|Primary|Mental Health (as Measured With the SF-36) at Baseline, Time 2 (2 Weeks Post-intervention) and Time 3 (6 Months Post-intervention)|The Mental Health Component Scale of the Medical Outcomes Study Short Form 36(SF-36) consists of a norm-based weighted average of the following subscales: Vitality, Social Functioning, Role Limitations due to Emotional Problems and Mental health. In the present study, scores ranged from a maximum of 72 (high levels of mental health) to a minimum of 12 (low levels of mental health).|Baseline, Time 2 (2 weeks post-intervention) and Time 3 (6 months post-intervention)|The intention-to-treat principle was followed, all participants were included in the analyses regardless of number of meetings attended.||units on a scale||Standard Deviation|Mean
714856|NCT00245466|Secondary|Serum Levels of Testosterone After 1, 2, and 3 Years||3 years|||nanogram per milliliter||Full Range|Median
714857|NCT00245466|Primary|Participants With Markedly Abnormal Change in Vital Signs and Body Weight|Vital signs and body weight included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of patients in each group with normal baseline and markedly abnormal value post-baseline.|3 years|These data include patients from the main study (FE200486 CS02) and the extension study (FE200486 CS02A).||participants|||Number
714858|NCT00245466|Primary|Liver Function Tests|The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases >3x ULN and ALT increases >3x ULN with concurrently increased bilirubin >1.5 ULN.|3 years|The data include patients from both the main study (FE200486 CS02) and the extension study FE200486 CS02A.||participants|||Number
714859|NCT00245557|Primary|Phosphorus Magnetic Resonance Spectroscopy (31P-MRS)|"The primary outcome is a phosphorus magnetic resonance spectroscopy (31P-MRS) signal quantified using a spectral time-domain fitting program based on the Marquadt-Levenberg non-linear, least-squares algorithm, that incorporates prior knowledge of spectral peak assignments, chemical shifts and J-coupling constants. Least squares means were calculated for average total signal using linear mixed effects models. Results are expressed as a spectroscopic index.
beta-nucleoside triphosphate (bNTP) Phosphocreatine (PCr) Total nucleoside triphosphate (NTP)"|at week 0 for both control and depressed, and at week 12 for depressed|||Spectroscopic Index||Standard Error|Least Squares Mean
714860|NCT00245557|Primary|Geriatric Depression Scale|This is a depression severity rating scale measuring symptoms of depression. Scale is from 0 (no depression symptoms) up to a maximum of 15 (severe depression symptoms).|baseline at study entry week 0|Not all subjects included in MRS analysis had baseline GDS data.||Units on a scale||Standard Deviation|Mean
714861|NCT00245557|Primary|HAM-D 17 (Hamilton Depression Rating Scale)|"This is a depression severity rating scale measuring symptoms of depression including mood, sleep, appetite, energy, motivation, guilt, suicidal ideation, concentration, physical complaints, paranoia, anxiety, effect on daily functioning and awareness of illness.
Scale is from 0 (no depression symptoms) up to a maximum of 66 (severe depression symptoms)."|baseline at study entry week 0|||Units on a scale||Standard Deviation|Mean
714862|NCT00245570|Secondary|Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 24 Hours Postdose|"The time to recovery from maximum percent fall is the
duration between the time at which the maximum percent fall in FEV1 after exercise challenge occurs and the
time when FEV1 returns to within 5% of the preexercise baseline for the first time."|Exercise challenge at 24 hours postdose|The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.||Minutes||Standard Deviation|Mean
714863|NCT00245570|Secondary|Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 8.5 Hours Postdose|"The time to recovery from maximum percent fall is the
duration between the time at which the maximum percent fall in FEV1 after exercise challenge occurs and the
time when FEV1 returns to within 5% of the preexercise baseline for the first time."|Exercise challenge at 8.5 hours postdose|The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.||Minutes||Standard Deviation|Mean
714864|NCT00245570|Secondary|Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 2 Hours Postdose|The time to recovery from maximum percent fall is the duration between the time at which the maximum percent fall in FEV1 after exercise challenge occurs and the time when FEV1 returns to within 5% of the preexercise baseline for the first time.|Exercise challenge at 2 hours postdose|The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.||Minutes||Standard Deviation|Mean
714865|NCT00245570|Secondary|Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60 Min) at 24 Hours Postdose|The measure included only the area below the pre-exercise baseline|0-60 minutes after the exercise challenge at 24 hours postdose|The secondary efficacy analysis used a MITT approach. If a patient received β-agonist rescue medication during the 60 minutes following exercise challenge, then the last pre-rescue FEV1 measurement was carried forward to 60 minutes. Patients with data from only one period were not included in the analysis.||Percent * minutes||Standard Deviation|Mean
714866|NCT00245570|Secondary|Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60 Min) at 8.5 Hours Postdose|The measure included only the area below the pre-exercise baseline|0-60 minutes after the exercise challenge at 8.5 hours postdose|The secondary efficacy analysis used a MITT approach. If a patient received β-agonist rescue medication during the 60 minutes following exercise challenge, then the last pre-rescue FEV1 measurement was carried forward to 60 minutes. Patients with data from only one period were not included in the analysis.||Percent * minutes||Standard Deviation|Mean
714867|NCT00245570|Secondary|Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60 Min) at 2 Hours Postdose|"The measure included only the area below the pre-exercise
baseline"|0-60 minutes after the exercise challenge at 2 hours postdose|The secondary efficacy analysis used a MITT approach. If a patient received β-agonist rescue medication during the 60 minutes following exercise challenge, then the last pre-rescue FEV1 measurement was carried forward to 60 minutes. Patients with data from only one period were not included in the analysis.||Percent * minutes||Standard Deviation|Mean
714868|NCT00245570|Secondary|Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Post-dose in Patients With EIB|In patients with EIB, the percent change from pre-exercise baseline FEV, to the lowest FEV1 within 60 minutes after exercise challenge (24 hours post-dose). The FEV1 measurement obtained 5 minutes before the exercise challenge was the baseline, and was specific to each exercise challenge.|0-60 minutes after the exercise challenge performed 24 hours after a single oral dose|The secondary efficacy analysis used the modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.||Percent Change from Baseline||Standard Deviation|Mean
714869|NCT00245570|Secondary|Maximum Percent Fall in FEV1 After Exercise Challenge at 8.5 Hours Post-dose in Patients With EIB|In patients with EIB, the percent change from pre-exercise baseline FEV, to the lowest FEV1 within 60 minutes after exercise challenge (8.5 hours post-dose). The FEV1 measurement obtained 5 minutes before the exercise challenge was the baseline, and was specific to each exercise challenge.|0-60 minutes after the exercise challenge performed 8.5 hours after a single oral dose|The secondary efficacy analysis used the modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.||Percent Change from Baseline||Standard Deviation|Mean
714870|NCT00245570|Secondary|Number of Patients Requiring β-Agonist Rescue Medication After Exercise Challenge at 24 Hours Postdose||0-90 minutes after the exercise challenge performed at 24 hours postdose|The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.||Participants|||Number
714871|NCT00245570|Secondary|Number of Patients Requiring β-Agonist Rescue Medication After Exercise Challenge at 8.5 Hours Postdose||0-90 minutes after the exercise challenge performed at 8.5 hours postdose|The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.||Participants|||Number
714872|NCT00245570|Secondary|Number of Patients Requiring β-Agonist Rescue Medication After Exercise Challenge at 2 Hours Postdose||0-90 minutes after the exercise challenge performed at 2 hours postdose|The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.||Participants|||Number
714873|NCT00245570|Primary|Maximum Percent Fall in Forced Expiratory Volume in 1 Second (FEV1) After Exercise Challenge at 2 Hours Post-dose in Patients With Exercise-Induced Bronchoconstriction (EIB)|In patients with EIB, the percent change from pre-exercise baseline FEV1 to the lowest FEV1 within 60 minutes after exercise challenge (2 hours post-dose). The FEV1 measurement obtained 5 minutes before the exercise challenge was the baseline, and was specific to each exercise challenge.|0-60 minutes after the exercise challenge performed 2 hours after a single oral dose|The primary efficacy analysis used the modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.||Percent Change from Baseline||Standard Deviation|Mean
714874|NCT00245635|Primary|Change in Total Score on the BDD-Y-BOCS Scale|To assess the change in total score on the Body Dysmorphic Disorder-Yale-Brown Obsessive Compulsive Scale (BDD-Y-BOCS) from baseline (visit 0) to endpoint (week 12). This is a 12-item scale that assesses obsessions and compulsions related to the patient's BDD. Each item's score ranges from 0 to 4, with a total possible score of 48 on the full assessment. Scores of 0 indicate no impairment, while scores of 4 indicate maximum impairment. Thus higher scores are considered to be a worse outcome.|Baseline compared to the study endpoint (week 12) [two time points]|||units on a scale||Standard Deviation|Mean
714875|NCT00245856|Secondary|Bleeding Events|Total major bleeding rate|3 months|All DVT treated patients analyzed together||participants||95% Confidence Interval|Number
714876|NCT00245856|Primary|New Venous Thromboembolism at 3 Months|New DVT or PE at 3 months confirmed by diagnostic testing|3 months|All DVT treated patients analyzed together||participants||95% Confidence Interval|Number
714877|NCT00245856|Primary|Percentage of Participants That Died at 3 Months||3 months|All DVT treated patients analyzed together||percentage of participants||95% Confidence Interval|Number
714878|NCT00245960|Secondary|Efficacy of Two Different Treatment Regimens of Etanercept in Treating Joint Disease.|Efficacy measured by the number of subjects achieving Psoriatic Arthritis response criteria at 24 weeks last observed carried forward (LOCF).|24 weeks|The analysis population was the Modified Intent to Treat (mITT).||participants|||Number
714879|NCT00245960|Primary|Efficacy of Two Different Treatment Regimens of Etanercept in Treating Skin Manifestations of Psoriasis Subjects With Psoriatic Arthritis.|Efficacy measured by the number of subjects with a Physician Global Assessment of Psoriasis of clear or almost clear at 12 weeks last observation carried forward (LOCF).|12 weeks|The analysis population was the Modified Intent to Treat (mITT) population.||participants|||Number
714880|NCT00246012|Other Pre-specified|Percentage of Participants Who Achieved a Best Overall Response as CR, PR, or SD - Phase 2|The CR: complete disappearance of all measurable and non-measurable target lesions and PR: 50% or more decrease in sum of the longest diameters of target lesion(s), with at least stable disease (SD) in all other evaluable disease in the absence of treatment failure.|Within 28 days of first infusion of study medication, within 1 week of the end of Cycles 2, 4, 6, 8; 3 months and 6 months post-last dose of study medication|The response-evaluable population included all the participants who were evaluable for response.||Percentage of Participants|||Number
714881|NCT00246012|Other Pre-specified|Area Under the Concentration Versus Time Curve Between Zero to Infinite Time (AUCinf) of Intetumumab - Phase 1 (Part 1)|The AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose|The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||mcg*day/mL||Standard Deviation|Mean
714882|NCT00246012|Secondary|Accumulation Ratio (R) of Intetumumab - Phase 1 (Part 2)|The R is obtained by dividing AUC at two different time points.|Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose|The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. Serum concentration data was insufficient to robustly estimate the accumulation ratio.|||||
714883|NCT00246012|Secondary|Volume of Distribution (Vz) of Intetumumab - Phase 1 (Part 2)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.|Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose|The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||mL/kg||Standard Deviation|Mean
714884|NCT00246012|Secondary|Total Clearance (CL) of Intetumumab After Intravenous Administration - Phase 1 (Part 2)|The CL is a quantitative measure of the rate at which a drug substance is removed from the body.|Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose|The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||mL/day/kg||Standard Deviation|Mean
714885|NCT00246012|Secondary|Half-life of Intetumumab - Phase 1 (Part 2)|Plasma decay half-life is the time measured for the plasma concentration of the drug to decrease by one half.|Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose|The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||Days||Standard Deviation|Mean
714886|NCT00246012|Secondary|Area Under the Serum Concentration Versus Time Curve (AUC) of Intetumumab - Phase 1 (Part 2)|The AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.|Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose|The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||mcg*day/mL||Standard Deviation|Mean
714887|NCT00246012|Secondary|Maximum Observed Serum Concentration (Cmax) of Intetumumab - Phase 1 (Part 2)|The maximum observed analyte concentration in serum was reported.|Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose|The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||Microgram per milliliter (mcg/mL)||Standard Deviation|Mean
714888|NCT00246012|Secondary|Change From Baseline in Brief Pain Inventory (BPI) Score - Phase 2|The BPI questionnaire is used to evaluate heath related quality of life. BPI allows participants to rate the severity of their pain on a scale of 0 (no pain) to 10 (pain as bad as you can imagine).|Day 1 (pre-dose) of Cycles 1, 2, 3; and final visit (3 weeks post-last dose of study medication)|The ITT population included all the participants who were randomly assigned to treatment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points.||Units on a scale||Standard Deviation|Mean
714889|NCT00246012|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Melanoma Subscale (FACT-MS) Score - Phase 2|The FACT-MS subscale is used to evaluate health related quality of life. It consists of 16 items: 12 items related to physical well-being, 3 to emotional well-being and 1 to social well-being. Scores for all items will range from 0 to 4. Total score ranges from 0-64; higher score indicates a more positive quality of life.|Day 1 (pre-dose) of Cycles 1, 2, 3; and final visit (3 weeks post-last dose of study medication)|The ITT population included all the participants who were randomly assigned to treatment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points.||Units on a scale||Standard Deviation|Mean
714890|NCT00246012|Secondary|Maximum Observed Serum Concentration (Cmax) of Intetumumab - Phase 2|The maximum observed analyte concentration in serum was reported.|Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose|The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab.||mcg/mL||Standard Deviation|Mean
714973|NCT00246805|Primary|Patients Mode Preference (VRS ON, VRS OFF, NO PREFERENCE)|Evaluation of patient preference concerning the programming of a specific algorithm for automatic Ventricular Rate Stabilization (VRS): Algorithm ON vs. OFF.|June 2009|||participants|||Number
714891|NCT00246012|Secondary|Time to Worsening in Eastern Cooperative Oncology Group (ECOG) Performance Status - Phase 2|Eastern Cooperative Oncology (ECOG) performance status: Participants will be graded from 0 (Fully active, able to carry on all pre-disease activities without restriction) to 4 (Completely disabled, cannot carry on any self-care, totally confined to bed or chair). Worsening in ECOG score was defined as ≥ 1 point increase in ECOG score from baseline.|Baseline (within 7 days of first infusion of study medication), Day 1 of all 8 cycles, 3 weeks or 1 week post-last dose, 3 months and 6 months post-last dose of study medication|The ITT population included all the participants who were randomly assigned to treatment.||Days||95% Confidence Interval|Median
714892|NCT00246012|Secondary|Duration of Response - Phase 2|Time duration required to achieve a CR or PR.|From the time of initial documented response (CR or PR) to the first documented sign of progression, assessed up to 6 months post-last dose of study medication|The response-evaluable population included all the participants who were evaluable for response. The results were reported as individual participant’s listings, but not statistically summarized.|||||
714893|NCT00246012|Secondary|Overall Survival (OS) - Phase 2|The OS is defined as the time from the date of randomization to the date of death due to any cause and was to be censored at the date that the subject is last known to be alive.|Every 3 months until death, until lost to follow-up, until withdrawal of consent, or until the Sponsor ends the study, as assessed up to 6 months post-last dose of study medication|The ITT population included all the participants who were randomly assigned to treatment.||Days||95% Confidence Interval|Median
714894|NCT00246012|Secondary|Percentage of Participants Who Achieved Stable Disease (SD) - Phase 2|The SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive disease (PD), taking as a reference the smallest sum longest diameter since the treatment started. The participants who achieved SD as the best response were reported.|Screening, within 1 week of the end of Cycles 2, 4, 6, 8 (but prior to the next cycle dose), and follow-up (3 and 6 months post-last dose where applicable)|The response-evaluable population included all the participants who were evaluable for response.||Percentage of Participants|||Number
714895|NCT00246012|Secondary|Percentage of Participants Who Achieved CR - Phase 2|The CR: complete disappearance of all measurable and non-measurable target lesions. The participants who achieved CR as the best response were reported.|Screening, within 1 week of the end of Cycles 2, 4, 6, 8 (but prior to the next cycle dose), and follow-up (3 and 6 months post-last dose where applicable)|The response-evaluable population included all the participants who were evaluable for response.||Percentage of Participants|||Number
714896|NCT00246012|Secondary|Percentage of Participants Who Achieved a Best Overall Tumor Response as Complete Response (CR) or Partial Response (PR) - Phase 2|The CR: complete disappearance of all measurable and non-measurable target lesions and PR: 50 percent (%) or more decrease in sum of the longest diameters of target lesion(s), with at least stable disease (SD) in all other evaluable disease in the absence of treatment failure. The best response achieved among all the evaluated time points was reported.|Screening, within 1 week of the end of Cycles 2, 4, 6, 8 (but prior to the next cycle dose), and follow-up (3 and 6 months post-last dose where applicable)|The response-evaluable population included all the participants who were evaluable for response.||Percentage of Participants|||Number
714897|NCT00246012|Primary|Progression-Free Survival (PFS) - Phase 2|The PFS was defined as the time from the date of randomization to the date of initial documented progressive disease (PD), or the date of initial documented symptomatic deterioration, or the date of death, whichever occurred first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of the longest diameter of target lesions, taking as a reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions.|From the date of randomization to date of initial documented progressive disease or death, whichever occured first, as assessed upto 6 months after last dose of study medication|The Intent-to-treat (ITT) population included all the participants who were randomly assigned to treatment.||Days||95% Confidence Interval|Median
714898|NCT00246012|Primary|Accumulation Ratio (R) of Intetumumab - Phase 1 (Part 1)|The R is obtained by dividing AUC at two different time points.|Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose|The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. Serum concentration data was insufficient to robustly estimate the accumulation ratio.|||||
714899|NCT00246012|Primary|Volume of Distribution (Vz) of Intetumumab - Phase 1 (Part 1)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.|Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose|The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||mL/kg||Standard Deviation|Mean
714900|NCT00246012|Primary|Total Clearance (CL) of Intetumumab After Intravenous Administration - Phase 1 (Part 1)|The CL is a quantitative measure of the rate at which a drug substance is removed from the body.|Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose|The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||mL/day/kg||Standard Deviation|Mean
714901|NCT00246012|Primary|Half-life of Intetumumab - Phase 1 (Part 1)|Plasma decay half-life is the time measured for the plasma concentration of the drug to decrease by one half.|Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose|The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||Days||Standard Deviation|Mean
714974|NCT00246805|Secondary|Potential Discomforts of Pacing Algorithm for Heart Rate Stabilization||January 2009||||||
714975|NCT00246805|Secondary|Number of Patients That Should Undergo Drug Therapy in Combination With Pacing to Stabilize Heart Rate||January 2009||||||
714976|NCT00246805|Secondary|Number of Patients That Should Undergo Atrioventricular Nodal (AVN) Ablation||January 2009||||||
714902|NCT00246012|Primary|Area Under the Serum Concentration Versus Time Curve (AUC) of Intetumumab - Phase 1 (Part 1)|The AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.|Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose|The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||mcg*day/mL||Standard Deviation|Mean
714903|NCT00246012|Primary|Maximum Observed Serum Concentration (Cmax) of Intetumumab - Phase 1 (Part 1)|The maximum observed analyte concentration in serum was reported.|Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose|The Pharmacokinetics (PK)-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab.||Microgram per milliliter (mcg/mL)||Standard Deviation|Mean
714904|NCT00246012|Primary|Number of Participants With Dose Limiting Toxicities (DLTs) - Phase 1|The DLT is defined as any Grade 3 or higher adverse event identified by the safety data monitoring committee as attributable to intetumumab except for hypersensitivity reactions, which are not considered DLTs unless there are 2 or more occurrences of greater than or equal to Grade 3 hypersensitivity reaction within a group.|Up to 21 days post-first infusion from the last treated participant in Phase 1|Safety population included all the participants who received at least 1 (partial or complete) dose of intetumumab/placebo or dacarbazine.||Participants|||Number
714905|NCT00246025|Secondary|Laboratory Analyses|Frequency of patients with possible clinically significant abnormalities.|First administration to end of study|||participants|||Number
714906|NCT00246025|Secondary|Volume of Blood Loss|Volume of blood loss for treated and operated patients during surgery.|Day 0|Safety set||mL||Standard Deviation|Mean
714907|NCT00246025|Secondary|Blood Transfusion|Blood transfusion for treated and operated patients on Day of surgery.|Day 0|Safety set||participants|||Number
714908|NCT00246025|Secondary|Number of Participants With Bleeding Events During Treatment Period|"Major bleeding events were defined as
fatal
clinically overt associated with loss of haemoglobin >=2g/dL in excess of what was expected
clinically overt leading to the transfusion of >=2 units packed cells or whole blood in excess of what was expected
symptomatic retroperitoneal, intracranial, intraocular or intraspinal
requiring treatment cessation
leading to re-operation
Clinically-relevant was defined as
spontaneous skin hematoma >=25 cm²
wound hematoma >=100 cm²
spontaneous nose bleed >5 min
macroscopic hematuria spontaneous or >24 hours if associated with an intervention
spontaneous rectal bleeding (more than a spot on toilet paper)
gingival bleeding >5 min
any other bleeding event considered clinically relevant by the investigator
Any bleeding events were defined as major, clinically-relevant and minor bleeding events. Minor bleeding events were defined as all other bleeding events that did not fulfil the criteria from above."|2 weeks|Safety set - Safety set includes all patients who were randomly assigned to the treatment, received at least one oral dose and went through surgery.||participants|||Number
714909|NCT00246025|Secondary|Number of Participants Who Died During Treatment Period|All cause death, as adjudicated by the VTE events committee.|2 weeks|FAS−op||percentage of participants|||Number
714910|NCT00246025|Secondary|Number of Participants With Pulmonary Embolism During Treatment Period|Pulmonary embolism confirmed by pulmonary scintigraphy, pulmonary angiography or contrast CT.|2 weeks|FAS−op||percentage of participants|||Number
714911|NCT00246025|Secondary|Percentage of Participants Who Have Total DVT (Deep Vein Thrombosis) During Treatment Period|Number of participants who have Total DVT during treatment period|2 weeks|FAS−tDVT - FAS−tDVT includes all patients who were randomised, treated, operated, and had evaluable venogram or confirmed symptomatic DVT.||percentage of participants|||Number
714912|NCT00246025|Secondary|Percentage of Participants With Symptomatic DVT (Deep Vein Thrombosis)|Number of Participants expressing DVT with symptoms|2 weeks|FAS−op - FAS−op includes all patients who were randomly assigned to the treatment, received at least one oral dose and went through surgery.||Percentage of participants|||Number
714913|NCT00246025|Secondary|Percentage of Participants Who Have Proximal DVT (Deep Vein Thrombosis) During Treatment Period|Number of participants who have Proximal DVT during treatment period|2 weeks|FAS−pDVT - FAS−pDVT includes all patients who were randomised, treated, operated, and had an evaluable venogram for proximal DVT or confirmed symptomatic proximal DVT.||percentage of participants|||Number
714914|NCT00246025|Secondary|Percentage of Participants Who Have a Composite of Major VTE (Defined as Proximal DVT and PE) and VTE Related Mortality|Number of participants with the composite of major VTE (defined as proximal DVT and PE) and VTE related mortality|2 weeks|FAS-major - FAS-major includes all patients who were randomised, treated, operated, and had an evaluable venogram for proximal DVT or confirmed symptomatic proximal DVT, PE, or VTE-related death.||percentage of participants|||Number
714915|NCT00246025|Primary|Percentage of Participants Who Have a Composite Endpoint Consisting of Total Venous Thromboembolic Event (VTE) and All Cause Mortality During the Treatment Period.|number of participants with the composite endpoint (total Venous Thromboembolic Event (VTE) and all cause mortality|2 weeks study medication|Full analysis set (FAS) - Full analysis set includes all patients who were randomly assigned to the treatment, received at least one oral dose, went through surgery, had an evaluable venogram for distal and proximal DVT, or had confirmed symptomatic DVT or PE, or died.||percentage of participants|||Number
714916|NCT00246090|Secondary|Duration of Response|Complete response (CR) is defined as the disappearance of all lesions. Partial response (PR) is defined as 30% decrease in lesion diameter.|From first documented complete or partial response until disease progression or death|Eligible Population||Days||Full Range|Median
714917|NCT00246090|Primary|Objective Response Rate|Based on Response Evaluation Criteria in Solid Tumors (RECIST), consisting of complete response (CR) plus partial response (PR). Defined as the best response from the start of treatment until disease progression or recurrence. Lesions measured by computed tomography (CT) scan and magnetic resonance imaging (MRI). Objective response rate: complete response (CR-disappearance of all lesions)+ partial response (PR-30% decrease in lesion diameter), Progressive Disease (PD-20% increase in lesion diameter), stable disease (SD-neither shrinkage nor increase of lesions).|Every two cycles|Eligible Population||Percentage of Participants|||Number
714977|NCT00246805|Secondary|Evaluation of Rate Irregularity Indicators and Patient's Symptoms||January 2009||||||
714918|NCT00246259|Other Pre-specified|Abnormal Involuntary Movement Scale (AIMS)|The AIMS is a 12-item scale to provide a numeric measure to the observed abnormal movements in different parts of the body. Information is collected after a brief neurological examination and is scored on a 5-point scale (0=none, 4=severe). Ten items are scored in a 5-point scale (0 = none/normal, 4 = severe) which evaluates abnormal movements in three main anatomic areas (orofacial area, extremities, and trunk). Two items are yes/no questions regarding dental status. Total scores range from 0 to 42 with higher values indicating more severity.|Baseline, Week 104 or LRV|Analysis population included all randomly assigned participants. Here 'n' signifies participants evaluable at each time point for each treatment arm, respectively.||Units on a scale||Standard Deviation|Mean
714919|NCT00246259|Other Pre-specified|Simpson Angus Scale (SAS)|The SAS is a 10-item scale used to measure the symptoms of parkinsonism (slow movements) or parkinsonian side-effects related to the use of antipsychotic medications. The 10 items are rated on a 5-point scale (0=complete absence, 4=extreme presence) after a brief neurological examination and observation of the participants’ gait (slow, shuffling walk). Total score is sum of individual item scores (range 0 to 40); higher score indicates more affected.|Baseline, Week 104 or LRV|Analysis population included all randomly assigned participants. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants evaluable at each time point for each treatment arm, respectively.||Units on a scale||Standard Deviation|Mean
714920|NCT00246259|Other Pre-specified|Barnes Akathisia Rating Scale (BARS) Global Clinical Assessment|The BARS evaluates akathisia (feeling of restlessness) associated with the use of antipsychotic medications, including an objective and a subjective component plus a global impression. Components are rated on a scale of 0 (normal or absence of restlessness)-3 (intense restlessness) and 0 (absent)-5 (severe akathisia) for the global clinical assessment. Number of participants in each global clinical assessment scale are reported.|Baseline, Week 104 or LRV|Analysis population included all randomly assigned participants. Here 'n' signifies participants evaluable at each time point for each treatment arm, respectively.||Participants|||Number
714921|NCT00246259|Secondary|Change From Baseline in Standardized Mental Component Scale Score in Short Form 36 (SF-36) at Week 104 or LRV|The SF-36 is a survey of participant health. It calculates two standardized scales: the standardized mental component scale and the standardized physical component scale. The standardized scales are calculated as weighted sums of the 8 scores, which are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Each item is scored on a 0-100 range; and standardized mental component scale score is calculated as weighted average of individual item scores on a 0-100 range, where 100 signify highest level of functioning. The change from baseline in mental component scale score was reported.|Up to Week 104 or LRV|The ITT analysis population included all the participants who received at least 3 doses of risperidone or 6 weeks of their oral antipsychotic, and had at least 1 post-baseline efficacy assessment. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||Units on a scale||Standard Deviation|Mean
714922|NCT00246259|Secondary|Change From Baseline in Drug Attitude Inventory (DAI-10) Score at Week 104 or LRV|The DAI, a 10-item scale to assess how the attitude of schizophrenia participants toward their medications may affect compliance. Respondents indicate 'true' or 'false' for each item. An overall calculated score ranged from -10 to 10, where a positive score indicated a positive subjective response (compliant), a negative score indicated non-compliance. Change: score at observation minus score at baseline.|Up to Week 104 or LRV|The ITT analysis population included all the participants who received at least 3 doses of risperidone or 6 weeks of their oral antipsychotic, and had at least 1 post-baseline efficacy assessment. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||Units on a scale||Standard Deviation|Mean
714923|NCT00246259|Secondary|Total Words Score Over Time|Controlled Word Association Test (COWAT) was used to assess verbal fluency. Participants are given 3 different letters of the alphabet and asked to say as many words beginning with each letter within a controlled time. Participants are then asked to identify as many words as possible in 3 different categories (animals, fruits and vegetables) within a specified period of time. The total score is a sum of all three categories scores. The total score ranges from 0-90, the higher the score the higher the verbal fluency.|Baseline, Week 104 or LRV|The ITT population:all participants who received at least 3 doses of risperidone or 6 weeks of oral antipsychotic, and had at least 1 post-baseline efficacy assessment. Here 'N' signifies participants evaluable for this measure and 'n' signifies participants evaluable at each time point for each treatment arm, respectively.||Units on a scale||Standard Deviation|Mean
714924|NCT00246259|Secondary|Number of Participants With Cognitive Assessments Using Trail B|Cognitive assessments were done using Trail test B, which measured variety of functions, including motor speed, visual scanning, attention and visual motor integration. In Trail B, 2 sets of circles contain numbers and letters, and the participant must connect them in alternating order. Trail B is also a measure of executive functions as it requires planning and decision-making.|Week -2, 104 or LRV|The ITT population included all participants who received at least 3 doses of risperidone or 6 weeks of oral antipsychotic, and had at least 1 post-baseline efficacy assessment.||Participants|||Number
714925|NCT00246259|Secondary|Number of Participants With Cognitive Assessment Using Trail A|Cognitive assessments were done using Trail test A which measured variety of functions, including motor speed, visual scanning, attention and visual motor integration. Participants must connect numbered circles in a variety of orders.|Week -2, 104 or LRV|The ITT population included all participants who received at least 3 doses of risperidone or 6 weeks of oral antipsychotic, and had at least 1 post-baseline efficacy assessment.||Participants|||Number
714926|NCT00246259|Secondary|Percentage of Participants With Relapse|"Relapse was defined according to Csernansky: “Psychiatric hospitalization; increased level of psychiatric care from start of maintenance period and 25 percent increase in total PANSS score from first maintenance visit, or 10 points increase where PANSS at start of maintenance period was 40 or less; deliberate self-injury, suicidal or homicidal ideation; violent to others; property damage; or substantial clinical deterioration, defined as CGI-C score of 6 (much worse)."|Week 10 (post-stability) up to Week 104 or LRV|The ITT analysis population included all the participants who received at least 3 doses of risperidone or 6 weeks of their oral antipsychotic, and had at least 1 post-baseline efficacy assessment. Here 'N' (number of participants analyzed) = participants evaluable for this measure.||Percentage of participants|||Number
714927|NCT00246259|Secondary|Change From Baseline Hamilton Anxiety Scale (HAM-A) Total Score at Week 104 or LRV|The HAM-A is a 14-item scale designed to measure anxiety in individuals. Each question reflects a symptom of anxiety and physical as well as mental symptoms are represented. The answers range from 0 which signifies a complete lack of that symptom to 4, which indicates a very severe show of anxiety with that symptom. Total score ranges from 0 to 56. Lower score indicates less affected.|Baseline, Week 104 or LRV|The ITT analysis population included all the participants who received at least 3 doses of risperidone or 6 weeks of their oral antipsychotic, and had at least 1 post-baseline efficacy assessment. Here 'n' = participants evaluable for this measure at given time points.||Units on a scale||Standard Deviation|Mean
714928|NCT00246259|Secondary|Change From Baseline in Young Mania Rating Scale (YMRS) at Week 104 or LRV|Co-morbid symptoms of mania are evaluated by change in YMRS Score which is an 11-item scale to assess symptoms of mania, Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 (the least) to 60 (the worst).|Baseline, Week 104 or LRV|The ITT analysis population included all the participants who received at least 3 doses of risperidone or 6 weeks of their oral antipsychotic, and had at least 1 post-baseline efficacy assessment. Here 'n' = participants evaluable for this measure at given time points.||Units on a scale||Standard Deviation|Mean
714929|NCT00246259|Secondary|Change From Baseline in Calgary Depression Symptom Scale (CDSS) Score at Week 104 or LRV|Co-morbid depressive symptoms are evaluated by change in CDSS Score which was developed to assess symptoms of depression in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self). It consists of 9 items, each scored from 0 (absent) to 3 (severe). The total score is a sum of the scores of each item and may range from 0 to 27. Higher score more severe pathology. Data presented here represents the change from baseline to endpoint.|Baseline, Week 104 or LRV|The ITT analysis population included all the participants who received at least 3 doses of risperidone or 6 weeks of their oral antipsychotic, and had at least 1 post-baseline efficacy assessment. Here 'n' = participants evaluable for this measure at given time points.||Units on a scale||Standard Deviation|Mean
714930|NCT00246259|Primary|Change From Baseline in Social and Occupational Functioning Assessment Scale (SOFAS) at Week 104 or LRV|The SOFAS focused exclusively on participants’ level of social and occupational functioning. The SOFAS is a 100 point single item scale that rates functioning of a participant. The scale values range from 1=most impaired to 100=healthiest individual. The scale also includes a rating point of 0=missing information.|Baseline, Week 104 or LRV|The ITT analysis population included all the participants who received at least 3 doses of risperidone or 6 weeks of their oral antipsychotic, and had at least 1 post-baseline efficacy assessment. Here 'n' = participants evaluable for this measure at given time points.||Units on a scale||Standard Deviation|Mean
714931|NCT00246259|Primary|Time to Relapse|"Time to relapse was calculated from the start of the maintenance phase to date of relapse according to Csernansky: “Psychiatric hospitalization; increased level of psychiatric care from start of maintenance period and 25 percent increase in total PANSS score from first maintenance visit, or 10 points increase where PANSS at start of maintenance period was 40 or less; deliberate self-injury, suicidal or homicidal ideation; violent to others; property damage; or substantial clinical deterioration, defined as Clinical Global Impression of Change (CGI-C) score of 6 (much worse)."|Week 10 (post-stability) up to Week 104 or LRV|The ITT analysis population included all the participants who received at least 3 doses of risperidone or 6 weeks of their oral antipsychotic, and had at least 1 post-baseline efficacy assessment.||Weeks||Standard Deviation|Mean
714932|NCT00246259|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 104 or Last Reported Visit (LRV)|The PANSS provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Baseline, Week 104 or LRV|Intent-to-treat (ITT) analysis population included all the participants who received at least 3 doses of risperidone or 6 weeks of their oral antipsychotic, and had at least 1 post-baseline efficacy assessment. One participant was missing as reported in oral antipsychotic arm. 'n' = participants evaluable for this measure at given time points.||Units on a scale||Standard Deviation|Mean
714933|NCT00246324|Secondary|Determine Pre- and On-treatment Cytokine ELISA, MMP ELISA and Bioassay||8 months||||||
714934|NCT00246324|Secondary|Determine Safety and Tolerability of Combination Therapy With Avonex Plus Doxycycline||8 months||||||
714935|NCT00246324|Secondary|Relapse Rates, Serum Matrix Metalloproteinase 9 Levels, Transendothelial Migration of Monocytes|Only 1 patient relapsed. Correlations between decrease serum metalloproteinase 9 levels and enhancing lesion activity reduction. Transendothelial migration of monocytes was suppressed. Adverse effects were mild. No adverse synergistic effects of combination therapy.|8 months|||participants|||Number
714936|NCT00246324|Primary|Gadolinium-enhancing (Gd+)Lesion Number Change.|Before treatment is the number of lesions per image from months -3, -2, -1, and 0. During treatment is the number of lesions from months 1,2, and 3. The mean number of Gd+ lesions during each treatment period was calculated for each patient as the total number of Gd+ lesions observed across all images divided by the number of images. Hence, the mean number of Gd+ lesions per patient represents the number of lesions per MRI.|8 months|||Gd+ lesions||95% Confidence Interval|Median
714937|NCT00246337|Secondary|Sustained Pain Freedom|Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), 3 (severe). Sustained pain freedom is defined as pain freedom at 2 hours and no headache return to mild/moderate/severe, no need for the optional 2nd dose, or any rescue medication, between 2 and 24 hours post dose.|2-24 hours post dose|"All Patients Treated (APT): included all randomized participants who took study medication and reported the post-dose assessment of the primary efficacy measure. Patients were counted in the treatment group to which they were randomized.
One patient in the MK974 300 mg group was excluded because baseline headache severity information was missing."||Participants|||Number
714978|NCT00247273|Secondary|Number of Participants With New Vertebral Fracture at Month 24, ITT Population|At least 1 new fractured vertebra|Baseline to Month 24|ITT||Participants|||Number
714938|NCT00246337|Secondary|Sustained Pain Relief|Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), 3 (severe). Sustained pain relief is defined as pain relief at 2 hours and no headache recurrence, no need for the optional 2nd dose, or any rescue medication, between 2 and 24 hours post dose.|2-24 hours post dose|"All Patients Treated (APT): included all randomized participants who took study medication and reported the post-dose assessment of the primary efficacy measure. Patients were counted in the treatment group to which they were randomized.
One patient in the MK974 300 mg group was excluded because baseline headache severity information was missing"||Participants|||Number
714939|NCT00246337|Secondary|Pain Freedom at 2 Hours|Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), 3 (severe). Pain freedom is defined as no pain (Grade 0) at 2 hours post dose.|2 hours post dose|"All Patients Treated (APT): included all randomized participants who took study medication and reported the post-dose assessment of the primary efficacy measure. Patients were counted in the treatment group to which they were randomized.
One patient in the MK974 300 mg group was excluded because baseline headache severity information was missing."||Participants|||Number
714940|NCT00246337|Primary|Pain Relief at 2 Hours|Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), 3 (severe). Pain Relief is defined as participants reporting relief from moderate to severe migraine headache (Grade 2 or 3) to mild or none (Grade 1 or 0) in the setting of a typical migraine attack.|2 hours post dose|"All Patients Treated (APT): included all randomized participants who took study medication and reported the post-dose assessment of the primary efficacy measure. Patients were counted in the treatment group to which they were randomized.
One patient in the MK974 300 mg group was excluded because baseline headache severity information was missing."||Participants|||Number
714941|NCT00246376|Primary|Total Cholesterol : HDL-C Ratio|Total cholesterol : HDL-C ratio: Fasting lipid levels|Measured at 24 weeks|All those who underwent the 2-week (first follow-up) measurement and continued in the study.||ratio||Standard Error|Mean
714942|NCT00246376|Primary|Total Cholesterol|Total cholesterol (mg/dL): Fasting lipid levels|Measured at 24 weeks|All those who underwent the 2-week (first follow-up) measurement and continued in the study.||mg/dL||Standard Error|Mean
714943|NCT00246376|Primary|HDL-C|HDL-C (mg/dL): Fasting lipid levels|Measured at 24 weeks|All those who underwent the 2-week (first follow-up) measurement and continued in the study.||mg/dl||Standard Error|Mean
714944|NCT00246376|Primary|Non-HDL-C|non-HDL-C (mg/dL): Fasting lipid levels|Measured at 24 weeks|All those who underwent the 2-week (first follow-up) measurement and continued in the study.||mg/dl||Standard Error|Mean
714945|NCT00246376|Secondary|Body Composition|"Body cell mass (kg)
Fat mass (kg)"|Measured at 24 weeks|The number corresponds to the number of subjects who completed the study (see Participant flow)||kg||Standard Error|Mean
714946|NCT00246376|Secondary|Insulin Sensitivity|Adiponectin (micrograms/ml)|Measured at 24 weeks|All subjects who completed 24 weeks.||micrograms/ml||Standard Error|Mean
714947|NCT00246376|Primary|Triglycerides|Triglycerides (mg/dL): Fasting lipid levels|Measured at 24 weeks|All those who underwent the 2-week (first follow-up) measurement and continued in the study.||mg/dL||Standard Error|Mean
714948|NCT00246519|Secondary|Adverse Metabolic Responses||9-18 weeks of treatment||||||
714949|NCT00246519|Primary|Blood Pressure Response (Delta BP (After 18 Weeks of Medication - Baseline)).||baseline to 18 weeks of treatment|A total 768 patients had at least monotherapy response data. Of the 386 patients assigned to the atenolol arm, 357 completed both drugs. Of the 382 assigned to the HCTZ arm, 355 completed both drugs. The delta blood pressure below is for patients who completed both drugs.||mmHg||Standard Deviation|Mean
714950|NCT00246571|Secondary|Circulating Tumor Cells (CTC)|Blood samples were collected to enumerate the number of total CTCs and insulin growth factor 1R positive (IGF-1R+) CTCs|Days 1 and 15 of Cycles 1, 2 and 3, Day 1 of Cycles 4 and 5, and every odd cycle thereafter, and EOT/withdrawal|ITT population. n = participants with available data at that time point.||cells/7.5 mL||Standard Deviation|Mean
714951|NCT00246571|Secondary|Circulating Endothelial Cells (CEC)|Blood samples were collected to enumerate the number of total CECs and sVEGFR1, sVEGFR2 and sVEGFR3 protein expression and/or cellular viability.|Days 1 and 15 of Cycles 1, 2 and 3, Day 1 of Cycles 4 and 5, and every odd cycle thereafter, and EOT/withdrawal|ITT population. n = participants with available data at that time point.||cells/mL||Standard Deviation|Mean
714952|NCT00246571|Secondary|Plasma Concentration of Soluble Kinase Insert Domain for Tyrosine (sKIT), a Stem Cell Factor Receptor|Plasma concentrations of sKIT were examined as a potential pharmacodynamic marker|Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5 and 7), and EOT/withdrawal|ITT population. n = participants with available data at that time point.||pg/mL||Standard Deviation|Mean
714953|NCT00246571|Secondary|Plasma Concentration of Soluble Placental Growth Factor (sPlGF)|Plasma concentrations of sPlGF were examined as a potential pharmacodynamic marker|Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5 and 7), and EOT/withdrawal|ITT population. n = participants with available data at that time point.||pg/mL||Standard Deviation|Mean
714954|NCT00246571|Secondary|Plasma Concentration of Soluble Vascular Endothelial Growth Factor A (sVEGF-A)|Plasma concentrations of sVEGF-A were examined as a potential pharmacodynamic marker|Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5, and 7), and EOT/withdrawal|ITT population. n = participants with available data at that time point.||pg/mL||Standard Deviation|Mean
714955|NCT00246571|Secondary|Plasma Concentration of Soluble Vascular Endothelial Growth Factor Receptor 3 (sVEGFR3)|Plasma concentrations of sVEGFR3 were examined as a potential pharmacodynamic marker|Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5, and 7), and EOT/withdrawal|ITT population. n = participants with available data at that time point.||pg/mL||Standard Deviation|Mean
714956|NCT00246571|Secondary|Plasma Concentration of Soluble Vascular Endothelial Growth Factor Receptor 2 (sVEGFR2)|Plasma concentrations of sVEGFR2 were examined as a potential pharmacodynamic marker|Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5, and 7), and EOT/withdrawal|ITT population. This outcome measure was not analyzed.||pg/mL||Standard Deviation|Mean
714957|NCT00246571|Secondary|Dose-corrected Ctrough of Total Drug (Sunitinib + SU012662)|Ctrough = plasma concentration of total drug (Sunitinib + SU012662) prior to study drug administration dose corrected using the following formula Intended Dose/Actual Dose, where Actual Dose: the dose the participant received over the last 10 consecutive days and Intended Dose: the starting dose per study protocol.|Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3|ITT population. n = number of participants with available data for those time points.||ng/mL||Standard Deviation|Mean
714958|NCT00246571|Secondary|Dose-corrected Ctrough of SU012662 (Metabolite of Sunitinib)|Ctrough = plasma concentration of SU012662 prior to study drug administration, dose corrected using the following formula Intended Dose/Actual Dose, where Actual Dose: the dose the participant received over the last 10 consecutive days and Intended Dose: the starting dose per study protocol.|Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3|ITT population. n = number of participants with available data for those time points.||ng/mL||Standard Deviation|Mean
714959|NCT00246571|Secondary|Dose-corrected Ctrough of Sunitinib|Ctrough = plasma concentration of sunitinib prior to study drug administration, dose corrected using the following formula Intended Dose/Actual Dose, where Actual Dose: the dose the participant received over the last 10 consecutive days and Intended Dose: the starting dose per study protocol.|Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3|ITT population. n = number of participants with available data for those time points.||ng/mL||Standard Deviation|Mean
714960|NCT00246571|Secondary|Ctrough of Total Drug (Sunitinib + SU012662)||Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3|ITT population. n = number of participants with available data for those time points.||ng/mL||Standard Deviation|Mean
714961|NCT00246571|Secondary|Ctrough of SU012662 (Metabolite of Sunitinib)||Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3|ITT population. n = number of participants with available data for those time points.||ng/mL||Standard Deviation|Mean
714962|NCT00246571|Secondary|Observed Plasma Trough Concentrations (Ctrough) of Sunitinib||Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3|ITT population. n = number of participants with available data for those time points.||ng/mL||Standard Deviation|Mean
714963|NCT00246571|Secondary|HRQoL and Disease Related Symptoms as Measured by EORTC-QLQ-C30 Breast Cancer Module (BR23) Score|BR23: measured disease related symptoms of dry mouth, eye pain, hair loss, hot flushes, attractiveness, future health, sexual activity, arm/shoulder pain, breast pain, swollen breast, and skin problems on the breast. Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.|Day 1, Cycle 1; Day 1, odd number cycles; and EOT/withdrawal|This participant-reported outcome was not analyzed for this report because the study did not meet its primary endpoint.||score on a scale|||Number
714964|NCT00246571|Secondary|Health Related Quality of Life (HRQoL) and Disease Related Symptoms as Measured by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QoL) Questionnaire (EORTC-QLQ-C30)|EORTC QLQ-C30: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much; global/QoL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Day 1, Cycle 1; Day 1, odd number cycles; and end of treatment (EOT)/withdrawal|This participant-reported outcome was not analyzed for this report because the study did not meet its primary endpoint.||score on a scale|||Number
714965|NCT00246571|Secondary|Overall Survival (OS)|Time in months from the date of randomization to date of death due to any cause. OS was calculated as (date of death minus randomization date plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Baseline until death (up to 3 years after first dose of study medication)|ITT population||months||95% Confidence Interval|Median
714966|NCT00246571|Secondary|Survival Probability at 1 Year|Probability that the participants will survive at end of 1 year from the first dose of study treatment. Calculated using data collected from baseline until death (up to 3 years after first dose of study medication). Probability calculated from Kaplan-Meier estimate.|Baseline until death (up to 3 years after first dose of study medication)|ITT population||ratio||95% Confidence Interval|Number
714967|NCT00246571|Secondary|Duration of Response (DR)|Time in months from the first documentation of objective tumor response (CR or PR) to objective tumor progression or death. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Time from first response to disease progression up to 3 years from first dose|ITT population||months||95% Confidence Interval|Median
714968|NCT00246571|Secondary|Proportion of Participants With Objective Response|Objective response based assessment of confirmed response (CR) or confirmed partial response (PR) according to RECIST. CR are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. PR are those with a greater than or equal to (≥) 30% decrease in the sum of the longest dimensions (SLD) of the target lesions taking as a reference the baseline SLD.|Baseline until response or disease progression (up to 3 years from first dose)|ITT population||percentage of participants||95% Confidence Interval|Number
714969|NCT00246571|Primary|Progression-Free Survival (PFS)|"Time in months from start of study treatment to first documentation of objective tumor progression (per RECIST) or death due to any cause. PFS was calculated as (first event date minus first randomization date plus 1) divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Baseline, every 6 weeks until disease progression or death (up to 3 years from first dose)|Intent-to-Treat (ITT) population: all participants who were randomized.||Months||95% Confidence Interval|Median
714970|NCT00246753|Secondary|Predictive Molecular Markers of Response to Treatment With Lapatinib (GW572016)|To assess the correlation between expression of molecular markers and patient response to treatment with GW572016|4 years|Data were not collected.|||||
714971|NCT00246753|Secondary|Time to Prostate-Specific Antigen (PSA) Progression|Measured from start date of treatment to date of PSA progression, defined as a 25% increase above the pretreatment value or the nadir PSA (whichever is lower) and a minimum increase of 5 ng/ml, confirmed 2 or more weeks later.|4 years|||days||95% Confidence Interval|Median
714972|NCT00246753|Primary|Number of Patients Experiencing Decline in Prostate-specific Antigen|Determine the number of patients with hormone-refractory prostate cancer who experience > 50% decline in PSA from baseline for 2 successive measurements at least 4 weeks apart after treatment with lapatinib ditosylate.|4 years|||Participants|||Count of Participants
714988|NCT00247273|Secondary|Percent Change From Baseline in Urine NTX/Cr at Month 24, ITT Population|Assayed by ELISA (enzyme-linked immunosorbent assay) for NTX and colorimetric assay for creatinine. Patient collected second urine voided between 6 and 9 am from day of clinic visit and day before clinic visit at Months 3, 6, 12 & 24.|Baseline to Month 24|ITT||Percent Change||95% Confidence Interval|Least Squares Mean
714989|NCT00247273|Secondary|Change From Baseline in Urine NTX/Cr at Month 24, ITT Population|Assayed by ELISA (enzyme-linked immunosorbent assay) for NTX and colorimetric assay for creatinine. Patient collected second urine voided between 6 and 9 am from day of clinic visit and day before clinic visit at Months 3, 6, 12 & 24.|Baseline to Month 24|ITT||nmol BCE / mmol Creatinine||95% Confidence Interval|Least Squares Mean
714990|NCT00247273|Secondary|Percent Change From Baseline in Urine NTX/Cr at Month 6, ITT Population|Assayed by ELISA (enzyme-linked immunosorbent assay) for NTX and colorimetric assay for creatinine. Patient collected second urine voided between 6 and 9 am from day of clinic visit and day before clinic visit at Months 3, 6, 12 & 24.|Baseline to Month 6|ITT||Percent Change||95% Confidence Interval|Least Squares Mean
714991|NCT00247273|Secondary|Change From Baseline in Urine Type-1 Collagen Cross-linked-N-telopeptide Corrected for Creatinine Clearance (NTX/Cr) at Month 6, ITT Population|Assayed by ELISA (enzyme-linked immunosorbent assay) for NTX and colorimetric assay for creatinine. Patient collected second urine voided between 6 and 9 am from day of clinic visit and day before clinic visit at Months 3, 6, 12 & 24. nmol BCE / mmol Creatinine = nanomoles bone collagen equivalents / millimoles Creatinine|Baseline to Month 6|ITT||nmol BCE / mmol Creatinine||95% Confidence Interval|Least Squares Mean
714992|NCT00247273|Secondary|Change From Baseline in Lumbar Spine BMD at Month 24, ITT Population|BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment.|Baseline to Month 24|ITT||g/cm^2||95% Confidence Interval|Least Squares Mean
714993|NCT00247273|Secondary|Percent Change From Baseline in Lumbar Spine BMD at Month 24, ITT Population|BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment.|Baseline to Month 24|ITT||Percent Change||95% Confidence Interval|Least Squares Mean
714994|NCT00247273|Secondary|Percent Change From Baseline in Lumbar Spine BMD at Month 24-Endpoint, Endpoint Population (Month 24)|BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment. LOCF - last observation carried forward (Last post-baseline measurement available to Month 24).|Baseline to Month 24 - Endpoint|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
714995|NCT00247273|Secondary|Change From Baseline in Lumbar Spine BMD at Month 12, ITT Population|BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment.|Baseline to Month 12|ITT||g/cm^2||95% Confidence Interval|Least Squares Mean
714996|NCT00247273|Secondary|Percent Change From Baseline in Lumbar Spine BMD at Month 12, ITT Population|BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment.|Baseline to Month 12|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
714997|NCT00247273|Primary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 12-Endpoint in Women With Postmenopausal Osteoporosis, Primary Efficacy Population|BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment. LOCF - last observation carried forward (Last post-baseline measurement available to Month 12).|Baseline to Month 12 - Endpoint|ITT (intent to treat) Population||Percent Change||95% Confidence Interval|Least Squares Mean
714998|NCT00247377|Secondary|Changes in Quality of Life- Mental Health Using SF-36 Questionnaire From Pre-operation to 12 Months Post-operation|change in quality of life survey response for mental health using the SF-36 questionnaire where 0 corresponds to no mental health well-being and 100 corresponds to complete mental health well-being|Baseline to 12 months|||units on a scale||Standard Deviation|Mean
714999|NCT00247377|Secondary|Changes in Quality of Life- Role- Emotional Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation|change in quality of life survey response for the emotional role using the SF-36 questionnaire where 0 corresponds to no emotional role and 100 corresponds to full emotional role|Baseline to 12 months|||units on a scale||Standard Deviation|Mean
715000|NCT00247377|Secondary|Changes in Quality of Life- Social Functioning Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation|change in quality of life survey response for social functioning as measured using the SF-36 questionnaire where 0 corresponds to no social functioning and 100 corresponds to full social functioning|Baseline to 12 months|||units on a scale||Standard Deviation|Mean
715001|NCT00247377|Secondary|Changes in Quality of Life- Vitality Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation|change in quality of life survey response for vitality as measured using the SF-36 questionnaire with worst score being 0 and best score being 100 on a 1-100 point scale.|Baseline to 12 months|||units on a scale||Standard Deviation|Mean
715002|NCT00247377|Secondary|Changes in Quality of Life: General Health Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation|change in quality of life survey response for general health using the SF-36 questionnaire where 0 corresponds to no general health satisfaction and 100 corresponds to complete health satisfaction|Baseline to 12 months|||units on a scale||Standard Deviation|Mean
715003|NCT00247377|Secondary|Changes in Quality of Life- Bodily Pain Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation|change in quality of life survey response for bodily pain using the SF-36 questionnaire where 0 corresponds to no bodily pain and 100 corresponds to complete bodily pain|Baseline to 12 months|||units on a scale||Standard Deviation|Mean
715004|NCT00247377|Secondary|Changes in Quality of Life- Role- Physical Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation|change in quality of life survey response for physical aspects of life using the SF-36 questionnaire where 0 corresponds to no Role-Physical and 100 corresponds to full Role-Physical|Baseline to 12 months|||units on a scale||Standard Deviation|Mean
715005|NCT00247377|Secondary|Cost of Procedure to the Medical Facility on Date of Procedure|operative and post-operative direct costs including hospital service costs per patient. costs reflect the average cost per patient in each of the two groups (band vs. bypass) at a single time point: date of surgery.|date of surgery|||dollars per patient||Standard Deviation|Mean
715006|NCT00247377|Primary|Excess Weight Loss From Pre-operation to 5 Years Post-operation|weight loss as measured by change in percent of excess body weight|Baseline to 5 years|Availability of subjects and protocol design||percent change||Standard Deviation|Mean
715010|NCT00247416|Primary|Percentage of Participants With Reduction in Grade 3/4 Neutropenia|Reduction grade 3/4 neutropenia|continuous throughout treatment, up to 25 weeks|||percentage of participants|||Number
715011|NCT00247416|Secondary|Effect of Dexamethasone Pre-treatment on Response Rate.|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Pre-treatment, pre-cycles 3 & 5, and up to 4 weeks after last treatment|||percentage of responders out of total||95% Confidence Interval|Number
715012|NCT00247611|Post-Hoc|Percentage of Participants Unemployed and on Disability||Data collected at Baseline|||percentage of participant|||Number
715013|NCT00247611|Primary|Visual Analog Scale Measure of Adherence to ART|"This measure asks participants to rate their adherence over the past 3 to 4 weeks using a line that marks from 0 to 100% of doses taken. For this study, this item was asked for each antiretroviral in one’s regimen and a total score was produced by averaging all reports. For main outcomes, perfect vs imperfect adherence was evaluated.
See: Walsh JC, Mandalia S, Gazzard BG. Responses to a 1 month self-report on adherence to antiretroviral therapy are consistent with electronic data and virological treatment outcome. AIDS.2002;16:269-77"|Measured at each clinical visit over 18 months of participation|Intent to treat included all participants with >=2 adherence assessments; OP sample further restricted this sample to those with >=6 assessments and no treatment interruptions over 18-months of participation. Multiple pairwise comparisons replaced missing values. HLM was used for over-time analyses on proportion reporting perfect adherence.||percent with 100% adherence|||Number
715014|NCT00247611|Secondary|Viral Load Count|Viral load data extracted from medical records beginning 30 days prior to baseline.|Measured over 18 months|||percentage with undetectable viral load|||Number
715015|NCT00247611|Primary|AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken|"This measure asks participants to report the number of doses taken on each of the past 3-days, relative to number he or she was prescribed to take, and produces a % adherence score. For this study, adherence over the past 3-days was established for each medication separately then averaged over the full regimen. For main outcomes, perfect vs imperfect adherence was evaluated. Significant findings on perfect/imperfect adherence were followed with sensitivity tests to determine if lowest threshold (eg., 90%, 80%, 70% adherence) effect was maintained.
See: Chesney MA, Ickovics JR, Chambers DB, et al. Self-reported adherence to antiretroviral medications among participants in HIV clinical trials: the AACTG adherence instruments. Patient care committee & adherence working group of the outcomes committee of the adult AIDS clinical trials group (AACTG). AIDS Care. 2000;12(3):255-266."|Measured at each clinical care visit over 18 months of participation|Intent to treat included all participants with >=2 adherence assessments; OP sample further restricted this sample to those with >=6 assessments and no treatment interruptions over 18-months of participation. Multiple pairwise comparison replaced missing values. HLM was used for over-time analyses on proportion reporting perfect adherence.||percent with 100% adherence|||Number
715016|NCT00240331|Secondary|Number of Randomised Participants That Experienced a Coronary or Peripheral Revascularisation (Including Above Ankle Limb Amputations).||Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years|||Participants|||Number
715017|NCT00240331|Secondary|Number of Randomised Participants That Experienced a Procedure as a Result of Stenosis or Thrombosis of the Vascular Access (Arteriovenous (AV) Fistulas and Grafts Only) for Haemodialysis.||Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years|||Participants|||Number
715018|NCT00240331|Secondary|Number of Randomised Participants With an Atherosclerotic Cardiac Event (Non-fatal Myocardial Infarction or Coronary Heart Disease (CHD) Death)||Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years|||Participants|||Number
715019|NCT00240331|Secondary|Number of Randomised Participants That Died From Non Cardiovascular Cause||Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years||||||
715020|NCT00240331|Secondary|Number of Randomised Participants That Died From Cardiovascular Cause||Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years|||Participants|||Number
715021|NCT00240331|Secondary|Number of Randomised Participants With a Major Cardiovascular Event or That Died From Any Known Cause||Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years|||Participants|||Number
715022|NCT00240331|Secondary|Number of Randomised Participants That Died From Any Cause.||Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years|||Participants|||Number
715023|NCT00240331|Primary|Number of Randomised Participants With a Major Cardiovascular Event (Non-fatal Stroke, Non-fatal Myocardial Infarction or Cardiovascular Death)||Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years|||Participants|||Number
715024|NCT00240487|Primary|Mean PaO2/FiO2 Ratio|Arterial blood gas measurements with cooximetry to evaluate arterial partial pressure of oxygen (PaO2) and fraction of inspired oxygen (FiO2) ratio. The mean PaO2/FiO2 ratio for each group after completion 8 hour of study participation was compared|8 hours|||mmHg||Standard Deviation|Mean
715025|NCT00240500|Primary|Clinical Review for Hepatitis B Infection Status|Chronic hepatitis B (HB) carrier is defined as positive for anti-HBc AND HBsAg at two or more consecutive time points|Over the entire 4 year follow up period (17 - 20 years)|||participants|||Number
715026|NCT00240500|Primary|Prevalence of Serological Markers for Hepatitis B Infection|It was initially planned to collect data from Year 16 through to Year 20 after primary vaccination. By the time the study protocol was approved, it was too late to collect data on Year 16. Only the subjects positive for HBsAg or anti Hepatitis B core antigen (anti-HBc) were tested for HBeAg & anti-HBe|Years 17, 18, 19 and 20.|||Percentage of participants (%)|||Number
715027|NCT00240500|Primary|Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations|During this follow-up study, it was planned to collect data from Year 16 through to Year 20 after primary vaccination. By the time the study protocol was approved, it was too late to collect data on Year 16. Therefore, the table presents mean concentrations expressed in milli-international units/milliliter (mIU/mL) at years 17, 18, 19 and 20.|Years 17, 18, 19 and 20.|||mIU/mL||95% Confidence Interval|Mean
715045|NCT00240981|Secondary|Chest-Press|Change from baseline in chest press strength at 6 months|baseline and 6 months|Participants with baseline and 1 post baseline measure.||Newtons||95% Confidence Interval|Mean
715028|NCT00240526|Primary|Number of Subjects With Different Hepatitis B Infection Statuses|"Categories hepatitis B (HB) infection:
Chronic infection: HBsAg and anti-HBc pos (pos) in more than two consecutive samples
False positive: single HB marker (HBsAg, HBeAg, anti-HBc) pos + all other markers negative (neg) in one sample. Consecutive time points all neg.
Possible subclinical breakthrough infection: One or more HB markers pos in one or more consecutive samples.
Isolated natural booster: >4-fold increase of anti-HBs concentrations if <100 mIU/mL at previous sample OR >2- fold increase of anti-HBs concentrations if >=100 mIU/mL at previous sample + other markers neg"|Over the entire follow up period (Final assessment of clinical significance was analyzed after the Year 20 time point)|Analysis was performed on the Long Term Total Cohort (LT total cohort). The maximum amount of subjects who have participated in any of the time points in this study has been given as number of participants analyzed.||subjects|||Number
715029|NCT00240526|Primary|Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection|Serological markers for hepatitis B infection assessed are hepatitis B surface antigen (HBsAg), antibodies to hepatitis B core antigen (anti-HBc), hepatitis B e antigen (HBeAg) and antibodies to hepatitis B e antigen (anti-HBe).|At Years 15, 16, 17, 18, 19 and 20|Analysis was performed on the Long Term Total Cohort (LT total cohort) on subjects with available data for the specified marker.||subjects|||Number
715030|NCT00240526|Primary|Adjusted Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values as Measured by ChemiLuminescence ImmunoAssay (CLIA)|"Anti-hepatitis B surface antigen (anti-HBs) antibody cut-off values assessed include 1.0 and 10 mIU/mL.
Note: Missing CLIA anti-HBs concentrations, for subjects with ELISA results available, are estimated by multiple imputations and GMCs and number of subjects were adjusted for these imputations."|At Years 19 and 20|Analysis was performed on subjects from the Long Term According-to-Protocol (LT ATP) cohort for immunogenicity on subjects with available data at the specified time-points||Subjects|||Number
715031|NCT00240526|Primary|Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA).|Anti-hepatitis B surface antigen (anti-HBs) antibody cut-off values assessed include 1.0 and 10 mIU/mL.|At Years 15, 16, 17, 18, 19 and 20|Analysis was performed on subjects from the Long Term According-to-Protocol (LT ATP) cohort for immunogenicity on subjects with available data at the specified time-points||subjects|||Number
715032|NCT00240526|Primary|Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by ChemiLuminescence ImmunoAssay (CLIA).|"Concentrations given as GMC expressed as milli-international unit per millilitre (mIU/mL).
Note: There was a change of assay kit at Year 19 time-point, thus for the sake of bridging, blood samples corresponding to Year 19 were re-tested with new CLIA. At Year 19 and 20, anti-HBs antibody concentrations tested with the CLIA with cut-off 6.2 mIU/mL."|At Years 19 and 20|Analysis was performed on subjects from the Long Term According-to-Protocol (LT ATP) cohort for immunogenicity on subjects with available data at the specified time-points||mIU/mL||95% Confidence Interval|Geometric Mean
715033|NCT00240526|Primary|Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by Enzyme-Linked Immunosorbent Assay (ELISA).|"Concentrations given as GMC expressed as milli-international unit per millilitre (mIU/mL).
Note: At Year 15 and 16, a commercial ELISA was used. From Year 17 to Year 20, anti-HBs antibody concentrations were tested with a validated in-house assay with cut-off 3.3mIU/mL."|At Years 15, 16, 17, 18, 19 and 20|Analysis was performed on subjects from the Long Term According-to-Protocol (LT ATP) cohort for immunogenicity on subjects with available data at the specified time-points||mIU/mL||95% Confidence Interval|Geometric Mean
715034|NCT00240539|Primary|Number of Subjects With Chronic and With Clinical HBV Infection|"Chronic HBV infection: HBsAg+ and anti-HBc+ at more than 2 consecutive time points.
Clinical HBV infection: Serologically confirmed, symptomatic HBV infection, and all HBV markers negative at consecutive time point."|From year 16 through to year 20|||subjects|||Number
715035|NCT00240539|Primary|Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus|Tested markers were hepatitis B surface antigen (HBsAg), antibody to hepatitis B core antigen (anti-HBc), hepatitis B envelope antigen (HBeAg) and antibody to hepatitis B envelope antigen (anti-HBe).|At Years 16, 17, 18,19 and 20 after primary vaccination|The analyses were performed on the ATP cohort for immunogenicity. Only subjects positive for HBsAg or anti-HBc markers were tested for HBeAg and anti-HBe markers for Year 17 to Year 20.||subjects|||Number
715036|NCT00240539|Primary|Number of Subjects Seropositive for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies|Seropositive subjects are subjects with anti-HBs antibody concentration ≥ 3.3 mIU/mL.|At Years 16, 17, 18, 19 and 20 after primary vaccination|The analyses were performed on the Long-Term According to protocol (ATP) cohort for immunogenicity. Due to subjects being lost to follow up or eliminated from the ATP cohort for immunogenicity, no data from subjects in HBsAg(+) & HBeAg(-) 4-dose Group and HBsAg(-) & HBeAg(-) 4-dose Group were analyzed.||subjects|||Number
715037|NCT00240981|Secondary|50-Meter Walking Speed (With a Load)|Change from baseline 50-Meter Walking Speed (with a load) at 6 months|baseline and 6 months|Participants with a baseline and one post baseline measure.||meters/second||95% Confidence Interval|Mean
715038|NCT00240981|Secondary|Total Fat Mass||baseline, 3 months, and 6 months|||Kilograms||Standard Deviation|Mean
715039|NCT00240981|Secondary|Total Lean Mass||baseline, 3 months, and 6 months|||Kilograms||Standard Deviation|Mean
715040|NCT00240981|Secondary|Late Life Functional Disability Index (LLFDI)|Percent change from baseline in the late life functional disability index at 6 months|baseline and 6 months|||units on a scale||95% Confidence Interval|Mean
715041|NCT00240981|Secondary|Stair-climbing Test (Loaded)|Change from baseline in Stair-climbing Test (loaded)|baseline and 6 months|Participants with one baseline and one post baseline measure.||Watts||95% Confidence Interval|Mean
715042|NCT00240981|Secondary|50-Meter Walking Speed (Without a Load)|Change from baseline 50-Meter Walking Speed (without a load) at 6 months|baseline and 6 months|Participants with a baseline and one post baseline measure.||meters/second||95% Confidence Interval|Mean
715043|NCT00240981|Secondary|Grip Strength|Change from baseline in grip strength in the dominant hand.|baseline and 6 months|The participants with baseline and one post baseline measure are included.||Kilograms||95% Confidence Interval|Mean
715044|NCT00240981|Secondary|Stair-climbing Test (Without a Load)|Change from baseline in the stair-climbing test (without a load) at 6 months.|baseline and 6 month|Participants with baseline and one post baseline measure.||Watts||95% Confidence Interval|Mean
715046|NCT00240981|Primary|Changes in Physical Performance Measured by an Exercise Testing Regimen|Primary outcome was a change from baseline in leg-press strength at 6 months.|baseline and 6 months|Participants with baseline and at least one post baseline measure.||Newtons||95% Confidence Interval|Mean
715047|NCT00240994|Primary|The Proportion of Participants With Graft Loss or Death Within 12 Months Post Kidney Transplantation|Graft loss is defined as the need for dialysis for more than 30 days duration, allograft nephrectomy, or the decision to withdraw immunosuppression due to graft failure.|Up to one year post kidney transplantation procedure|Intent-to-treat||Proportion of participants|||Number
715048|NCT00241176|Secondary|Clinical Global Impression Severity Scores|The Clinical Global Impression scale (CGI) is a classic instrument for making global assessments. This scale yields three different measures: 1. Severity of illness (7-point scale, with 7 being the most impaired; assessment of patient's current symptom severity, referred to here as CGIs), 2. Global improvement (7-point scale, with 7 being the most impaired; comparison of patient's baseline condition with his/her current condition, referred to here as CGIi), 3. Efficacy index (4 point x 4 point rating scale, comparison of patient's baseline condition with a ratio of current therapeutic benefit to severity of side effects)|24 Months|||units on a scale||Standard Deviation|Mean
715049|NCT00241176|Primary|Calculating Difference Between Means (Baseline and Endpoint Scores on the Yale Global Tic Severity Scale Subscales)|The Yale Global Tic Severity Scale (YGTSS) is a clinical rating instrument that was designed for use in studies of Tourette's syndrome and other tic disorders. The YGTSS provides an evaluation of the number, frequency, intensity, complexity, and interference of motor and phonic symptoms. The maximum YGTSS Global score is 100, while the maximum motor score is 25, the maximum vocal score is 25, and the maximum impairment score is 50. Higher scores indicate more severe tics.|8 Weeks|||units on a scale||Standard Deviation|Mean
715050|NCT00241280|Primary|Rate of Contact Lens Related Serious and Significant Events (SSE)|The number of Contact-Lens related Serious and Significant Adverse Events were reported for each study lens. The incidence of rates of contact-lens related SSEs were calculated as (# of subjects that experienced an event)/(total # subjects). If there were multiple diagnostic findings, the event was categorized under the highest event level diagnostic.|Throughout the duration of the study (1 Year)|All subjects that were dispensed a study lens.||percentage of Subjects|||Number
715051|NCT00241280|Primary|Monocular Contact Lens Snellen Visual Acuity Worse Than 20/40|Percentage of subject eyes reported with visual acuity worse than 20/40 at each study visit.|Follow-up Visits- 24 hr, 1, 4, 12, 24,36, and 52 weeks|The analysis population consists of subjects that completed all study visits, without a major protocol deviation. The analysis was conducted on these subject eyes.||Percentage of Subjects Eyes|Participants||Number
715052|NCT00241358|Secondary|To Determine the Pharmacokinetics of IV AMD3100 (IV Donor Arm Only) as Measured by Mean AUC From Time 0 to Infinity|-Blood for pharmacokinetics were drawn prior to infusion, 15 minutes after infusion, 30 minutes after infusion, 45 minutes after infusion, 1 hour after infusion, 2 hours after infusion, 4 hours after infusion, 6 hours after infusions, and 24 hours after infusion|0 to 24 hours after dose of IV AMD3100|Pharmacokinetics were not performed on 2 patients who were considered replacement patients.||ng*hr/mL||Full Range|Mean
715053|NCT00241358|Secondary|To Determine the Pharmacokinetics of IV AMD3100 (IV Donor Arm Only) as Measured by Cmax|-Blood for pharmacokinetics were drawn prior to infusion, 15 minutes after infusion, 30 minutes after infusion, 45 minutes after infusion, 1 hour after infusion, 2 hours after infusion, 4 hours after infusion, 6 hours after infusions, and 24 hours after infusion|0 to 24 hours after dose of IV AMD3100|Pharmacokinetics were not performed on 2 patients who were considered replacement patients.||ng/ml||Full Range|Mean
715054|NCT00241358|Secondary|Proportion of Donors Who Experience Infusional Toxicity (Donor Only)|-Defined as hypersensitivity reactions. Evaluated by physical exam, blood pressure, heart rate, respirations and temperature one hour prior to the infusion and then 15 minutes, 30 minutes, one hour, 2 hours, and 4 hours post-infusion|Day +1 to +3 (SC donor arm) and Day -3 to +3 (IV donor arm)|||Participants|||Count of Participants
715055|NCT00241358|Secondary|Quality of Life During Stem Cell Mobilization (Recipients Only)||48-72 hours after last dose of AMD3100|-Quality of life questionnaires were not collected from the recipients.|||||
715056|NCT00241358|Secondary|Proportion of Recipients Who Experience Mortality Before Day 100 After Transplant (Recipient Only)|-Death that results from a transplant procedure related complication (e.g. infection, organ failure, hemorrhage, GVHD) rather than from relapse of the underlying disease or an unrelated cause|100 days after transplant|Only 38 recipients received stem cell products on study. The others were not eligible due to relapse/progression, poor donor collection, or receiving non-AMD3100 mobilized cells.||Participants|||Count of Participants
715057|NCT00241358|Secondary|Proportion of Recipients Who Experience Chronic GVHD (Recipient Only)|-Incidence and severity of chronic GVHD will be assessed based on the Seattle criteria|Between Day +100 and +365 post-transplant|Only 28 recipients received stem cell products on study. The others were not eligible due to relapse/progression, poor donor collection, receiving non-AMD3100 mobilized cells, or death before day +100.||Participants|||Count of Participants
715058|NCT00241358|Primary|Proportion of Recipients Who Successfully Engraft by Day +21 After Transplant (Recipient Only)|-Defined as neutrophil count ≥ 500/ul following conditioning regimen induced nadir|Day +21|Only 38 recipients received stem cell products on study. The others were not eligible due to relapse/progression, poor donor collection, or receiving non-AMD3100 mobilized cells.||Participants|||Count of Participants
715059|NCT00241358|Primary|Proportion of Recipients Who Experience Grade 2-4 Acute GVHD (Recipient Only)|-Incidence and severity of acute GVHD (aGVHD) will be assessed based on the Seattle criteria|By Day 100 after transplant|Only 38 recipients received stem cell products on study. The others were not eligible due to relapse/progression, poor donor collection, or receiving non-AMD3100 mobilized cells.||Participants|||Count of Participants
715060|NCT00241358|Primary|Proportion of Donors From Whom a Sufficient Number of Cells for Transplantation Are Collected in no More Than 2 LP Procedures Following Mobilization With AMD3100 (Donor Only)|-Defined as the proportion of donors collecting >2.0x106 CD34+ cells/kg [recipient weight]|Day 1-3|||Participants|||Count of Participants
715061|NCT00241644|Secondary|Number of Seropositive Subjects|Seropositive subjects are defined as subjects with anti-rotavirus IgA antibody concentration ≥ 20 U/mL.|One month after the last vaccine or placebo dose|Analysis was performed on the ATP cohort for immunogenicity.||subjects|||Number
715062|NCT00241644|Secondary|Geometric Mean Concentration of Anti-rotavirus Immunoglobulin A (IgA) Antibodies|Geometric mean concentrations are given as Units per milliliter (U/mL).|One month after the last vaccine or placebo dose|Analysis was performed on the ATP cohort for immunogenicity.||U/mL||95% Confidence Interval|Geometric Mean
715063|NCT00241644|Secondary|Number of Seroconverted Subjects|Seroconverted subjects are defined as subjects with appearance of anti-rotavirus IgA antibody concentration ≥ 20 U/mL in subjects initially (i.e. prior to the first dose of vaccine or placebo) seronegative for rotavirus.|One month after the last vaccine or placebo dose|Analysis was performed on the ATP cohort for immunogenicity, only for inititally seronegative subjects.||subjects|||Number
715064|NCT00241644|Secondary|Geometric Mean Concentration of Anti-rotavirus Immunoglobulin A (IgA) Antibodies in Initially Seronegative Subjects|An initially seronegative subject is a subject whose IgA antibody concentration was below the assay cut-off value of 20 Units per milliliter (U/mL) before administration of the first vaccine dose.|One month after the last vaccine dose|Analysis was performed on the ATP cohort for immunogenicity, only for initially seronegative subjects.||Units per milliliter (U/mL)||95% Confidence Interval|Geometric Mean
715065|NCT00241644|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|From the first dose of vaccine or placebo up to end of the study|||subjects|||Number
715066|NCT00241644|Secondary|Number of Subjects With Adverse Events (AEs) or Serious Adverse Events (SAEs) Leading to Drop Out|"An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above."|From the first dose of vaccine or placebo up to end of the study|||subjects|||Number
715067|NCT00241644|Secondary|For Subjects in Cohort 2 South Africa and the Cohort in Malawi: Number of Subjects With Severe Rotavirus Gastroenteritis Caused by the Circulating Wild-type Rotavirus Strains, Classified by Rotavirus Type|"Number of subjects presenting with three or more looser than normal stools or watery stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample with a score ≥ 11 on the 20-point Vesikari scoring system.
Rotavirus types were G1 wild type (WT) and non-G1."|During the period from 1 year of age to study end|The analysis was performed on the ATP cohort for efficacy of the second efficacy period.||subjects|||Number
715068|NCT00241644|Secondary|For Subjects in Cohort 2 South Africa and the Cohort in Malawi: Number of Subjects With Severe Rotavirus Gastroenteritis Caused by the Circulating Wild-type Rotavirus Strains, Classified by Rotavirus Type|"Number of subjects presenting with three or more looser than normal stools or watery stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample with a score ≥ 11 on the 20-point Vesikari scoring system.
Rotavirus types were G1 wild type (WT) and non-G1."|During the period from 2 weeks after the last dose of vaccine or placebo until study end|The analysis was performed on the ATP cohort for efficacy of the combined efficacy follow-up periods.||subjects|||Number
715069|NCT00241644|Secondary|For Subjects in Cohort 2 South Africa and the Cohort in Malawi: Number of Subjects Hospitalized and/or With Supervised Re-hydration Therapy Due to Rotavirus Gastroenteritis (RV GE) Episode Caused by the Circulating Wild-type RV Strains|RV GE caused by the circulating wild-type rotavirus strain: three or more looser than normal stools or watery stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample collected as soon as possible after the symptoms begin.|During the period from 1 year of age to study end|The analysis was performed on the ATP cohort for efficacy of the second efficacy period.||subjects|||Number
715070|NCT00241644|Secondary|For Subjects in Cohort 2 South Africa and the Cohort in Malawi: Number of Subjects Hospitalized and/or With Supervised Re-hydration Therapy Due to Rotavirus Gastroenteritis (RV GE) Episode Caused by the Circulating Wild-type RV Strains|RV GE caused by the circulating wild-type rotavirus strain: three or more looser than normal stools or watery stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample collected as soon as possible after the symptoms begin.|During the period from 2 weeks after the last dose of vaccine or placebo until study end|The analysis was performed on the ATP cohort for efficacy of the combined efficacy follow-up periods.||subjects|||Number
715071|NCT00241644|Secondary|For Subjects in Cohort 2 South Africa and the Cohort in Malawi: Number of Subjects With Severe Rotavirus Gastroenteritis (RV GE) Caused by the Circulating Wild-type Rotavirus Strains|Number of subjects presenting with three or more looser than normal stools or watery stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample with a score ≥ 11 on the 20-point Vesikari scoring system.|During the period from 1 year of age to study end|The analysis was performed on the According-To-Protocol (ATP) cohort for efficacy of the second efficacy period.||subjects|||Number
715072|NCT00241644|Secondary|For Subjects in Cohort 2 South Africa and the Cohort in Malawi: Number of Subjects With Severe Rotavirus Gastroenteritis (RV GE) Caused by the Circulating Wild-type Rotavirus Strains|Number of subjects presenting with three or more looser than normal stools or watery stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample with a score ≥ 11 on the 20-point Vesikari scoring system.|During the period from 2 weeks after the last dose of vaccine or placebo until study end|The analysis was performed on the According-To-Protocol (ATP) cohort for efficacy of the combined efficacy follow-up periods.||subjects|||Number
715120|NCT00249795|Secondary|First Hospitalisation for Heart Failure (HF)|The considered event is the first overnight hospital stay for HF over the duration of the follow-up, after validation by the EAC.|Median follow-up of 4.5 years|The intent-to-treat (ITT) population was used for this analysis.||participants|||Number
715122|NCT00249795|Secondary|Death From Any Cause|The considered event is the death over the duration of the follow-up whatever the cause, cardiovascular or non-cardiovascular.|Median follow-up of 4.5 years|The intent-to-treat (ITT) population was used for the analysis.||participants|||Number
715073|NCT00241644|Secondary|Number of Subjects Hospitalized and/or With Supervised Re-hydration Therapy Due to Rotavirus Gastroenteritis (RV GE) Caused by the Circulating Wild-type Rotavirus Strain|RV GE caused by the circulating wild-type rotavirus strain: three or more looser than normal stools or watery stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample collected as soon as possible after the symptoms begin.|From 2 weeks after the last vaccine or placebo dose up to 1 year of age|Analysis was performed on the ATP cohort for efficacy||subjects|||Number
715074|NCT00241644|Secondary|Number of Subjects Reporting Severe Gastroenteritis of Any Cause|Number of subjects with gastroenteritis (three or more looser than normal stools or watery stools within a day) that scored ≥ 11 on the 20-point Vesikari scoring system.|From 2 weeks after the last vaccine or placebo dose up to 1 year of age|Analysis was performed on the ATP cohort for efficacy.||subjects|||Number
715075|NCT00241644|Secondary|In South Africa, Number of Subjects With Severe Rotavirus Gastroenteritis Caused by the Circulating Wild-type Rotavirus Strain|Number of subjects presenting with three or more looser than normal stools or watery stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample with a score ≥ 11 on the 20-point Vesikari scoring system.|From 2 weeks after the third dose of vaccine or placebo up to 1 year of age|"Analysis was performed on the ATP cohort for efficacy, only for the subset of subjects in South Africa who were fully vaccinated before the beginning of the rotavirus season.
For this analysis, data from Rotarix 2-dose Group and Rotarix 3-dose Group were pooled into one group (Rotarix pooled Group)."||subjects|||Number
715076|NCT00241644|Secondary|Number of Subjects With Severe Rotavirus Gastroenteritis Caused by the Circulating Wild-type Rotavirus Strain|Number of subjects presenting with three or more looser than normal stools or watery stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample with a score ≥ 11 on the 20-point Vesikari scoring system.|From the first vaccine or placebo dose up to 1 year of age|||subjects|||Number
715077|NCT00241644|Secondary|Number of Subjects Reporting Any Rotavirus Gastroenteritis Caused by the Circulating Wild-type Rotavirus Strain|Number of subjects presenting with three or more looser than normal stools or watery stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample.|From 2 weeks after the last vaccine or placebo dose up to 1 year of age|Analysis was performed on the ATP cohort for efficacy||subjects|||Number
715078|NCT00241644|Secondary|Number of Subjects With Severe Rotavirus Gastroenteritis Caused by the Circulating Wild-type Rotavirus Strain, Classified by Rotavirus Type|"Number of subjects presenting with three or more looser than normal stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample with a score ≥ 11 on the 20-point Vesikari scoring system.
Rotavirus types were G1 wild type (WT) and non-G1."|From 2 weeks after the last vaccine or placebo dose up to 1 year of age|Analysis was performed on the ATP cohort for efficacy||subjects|||Number
715079|NCT00241644|Primary|Number of Subjects With Severe Rotavirus Gastroenteritis (RV GE) Caused by the Circulating Wild-type Rotavirus Strain|Number of subjects presenting with three or more looser than normal stools or watery stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample with a score ≥ 11 on the 20-point Vesikari scoring system.|From 2 weeks after the last vaccine or placebo dose up to 1 year of age|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy||subjects|||Number
715080|NCT00247676|Secondary|Plasma Concentration of Soluble KIT (sKIT)|Plasma concentrations of sKIT that may be associated with tumor proliferation or angiogenesis were collected from a subset of subjects and analyzed by ELISA analysis. Soluble protein values: Baseline concentration (pM) and ratio to Baseline at each timepoint; ratio to Baseline = plasma concentration of soluble protein at timepoint / concentration of soluble protein at baseline. Samples below the limit of quantitation and samples with insufficient volume available were excluded.|Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 5 (Day 28)|ITT||pg/mL||Full Range|Median
715081|NCT00247676|Secondary|Plasma Concentration of Soluble VEGF Receptor-3 (sVEGFR-3)|Plasma concentrations of sVEGFR-3 that may be associated with tumor proliferation or angiogenesis were collected from a subset of subjects and analyzed by ELISA. Soluble protein values: Baseline concentration (pM) and ratio to Baseline at each timepoint; ratio to Baseline = plasma concentration of soluble protein at timepoint / concentration of soluble protein at baseline. Samples below the limit of quantitation and samples with insufficient volume available were excluded.|Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 5 (Day 28)|ITT||pg/mL||Full Range|Median
715082|NCT00247676|Secondary|Plasma Concentration of Soluble VEGF Receptor-2 (sVEGFR-2)|Plasma concentrations of sVEGFR-2 that may be associated with tumor proliferation or angiogenesis were collected from a subset of subjects and analyzed by ELISA. Soluble protein values: Baseline concentration (pM) and ratio to Baseline at each timepoint; ratio to Baseline = plasma concentration of soluble protein at timepoint / concentration of soluble protein at baseline). Samples below the limit of quantitation and samples with insufficient volume available were excluded.|Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 5 (Day 28)|ITT||pg/mL||Full Range|Median
715083|NCT00247676|Secondary|Plasma Concentration of VEGF-C|Plasma concentrations of VEGF-C that may be associated with tumor proliferation or angiogenesis were collected from a subset of subjects and analyzed by ELISA. Soluble protein values: Baseline concentration (pM) and ratio to Baseline at each timepoint; ratio to Baseline = plasma concentration of soluble protein at timepoint / concentration of soluble protein at baseline. Samples below the limit of quantitation and samples with insufficient volume available were excluded.|Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 5 (Day 28)|ITT||pg/mL||Full Range|Median
715084|NCT00247676|Secondary|Plasma Concentration of Vascular Endothelial Growth Factor (VEGF)|Plasma concentrations of VEGF that may be associated with tumor proliferation or angiogenesis were collected from a subset of subjects and analyzed by e nzyme-linked immunosorbent assay (ELISA). Soluble protein values: Baseline concentration (pM) and ratio to Baseline at each timepoint; ratio to Baseline = plasma concentration of soluble protein at timepoint / concentration of soluble protein at baseline. Samples below the limit of quantitation and samples with insufficient volume available were excluded.|Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 5 (Day 28)|ITT||picograms (pg)/mL||Full Range|Median
715085|NCT00247676|Secondary|Tissue Tumor Markers Assessed by Tumor Biopsy|Provision of previously collected tumor paraffin blocks (or at least 5-10 4-micron slides prepared from the paraffin block) for correlative laboratory analysis was optional. For all subjects showing OR on study, it was highly recommended to provide previously collected paraffin blocks (or at least 5-10 4-micron slides prepared from the paraffin block). These samples were to be analyzed for markers that may be associated with tumor proliferation or angiogenesis.|Day 28 of Cycle 1 (optional)|ITT. Tumor biopsy results were collected optionally in 5 subjects; however, no evaluations were performed.||intensity score||Standard Deviation|Mean
715086|NCT00247676|Secondary|Circulating Endothelial Cells (CECs) and Circulating Endothelial Progenitor Cells (CEPs)|Blood samples for the assessment of CECs and circulating CEPs were planned to be obtained for subjects in Part 1 of the study, and for a subset of subjects in Part 2 of the study to complete the angiogenic profile of unresectable hepatocellular carcinoma, in addition to the soluble protein evaluation.|Cycle 1 (Days 1, 14), Cycle 2 (Days 1, 28), Cycle 5 (Day 1)|ITT. Blood samples for CECs and CEP cells were collected during the study, but evaluations of these samples were not performed.||cells/mL||Standard Deviation|Mean
715087|NCT00247676|Secondary|Dose-Corrected Ctrough of Total Drug (Sunitinib + SU-012662)|Data was dose-corrected to the starting dose (dose-corrected Ctrough = observed Ctrough x [starting dose/actual dose]).|Cycle 1 (Days 14, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28)|PK||ng/mL||Standard Deviation|Mean
715088|NCT00247676|Secondary|Dose-Corrected Ctrough of SU-012662 (Metabolite of Sunitinib)|Data was dose-corrected to the starting dose (dose-corrected Ctrough = observed Ctrough x [starting dose/actual dose]).|Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28)|PK||ng/mL||Standard Deviation|Mean
715089|NCT00247676|Secondary|Dose-Corrected Ctrough of Sunitinib|Data was dose-corrected to the starting dose (dose-corrected Ctrough = observed Ctrough x [starting dose/actual dose]).|Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28)|PK||ng/mL||Standard Deviation|Mean
715090|NCT00247676|Secondary|Ctrough of Total Drug (Sunitinib + SU-012662)|Ctrough = the concentration prior to study drug administration.|Cycle 1 (Days 14, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28)|PK||ng/mL||Standard Deviation|Mean
715091|NCT00247676|Secondary|Ctrough of SU-012662 (Metabolite of Sunitinib)|Ctrough = the concentration prior to study drug administration.|Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28)|PK||ng/mL||Standard Deviation|Mean
715092|NCT00247676|Secondary|Trough Plasma Concentrations (Ctrough) of Sunitinib|Ctrough = the concentration prior to study drug administration.|Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28)|Pharmacokinetic (PK) = All subjects enrolled in the study who at least 1 PK sample collected.||nanograms (ng)/milliliter (mL)||Standard Deviation|Mean
715093|NCT00247676|Secondary|1-Year Survival Probability|Probability of survival 1 year after the first dose of study treatment.|From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter up until 1 year.|ITT||Probability|||Number
715094|NCT00247676|Secondary|Overall Survival (ITT Child Pugh Class A Subject Population)|Time from the date of first dose of study medication to the date of death due to any cause.|From start of study treatment until death.|ITT Child Pugh Class A (assessment of liver function) subject population||Weeks||95% Confidence Interval|Median
715095|NCT00247676|Secondary|Overall Survival (Overall ITT)|Time from the date of first dose of study medication to the date of death due to any cause.|From start of study treatment until death.|ITT||Weeks||95% Confidence Interval|Median
715096|NCT00247676|Secondary|Time to Tumor Progression (ITT Child Pugh Class A Subject Population)|Time from the start of study treatment to the first documentation of objective tumor progression.|From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter|ITT Child Pugh Class A (assessment of liver function) subject population||Weeks||95% Confidence Interval|Median
715097|NCT00247676|Primary|Objective Response (CR or PR)|Number of patients with objective response: confirmed CR or confirmed PR according to RECIST. CR was defined as the disappearance of all target lesions. A PR was defined as a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. To be assigned a status of PR or CR, changes in tumor measurements in patients with responding tumors had to have been confirmed by repeat studies that were performed ≥ 4 weeks after the criteria for response were first met.|From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter|ITT||participants|||Number
715098|NCT00247676|Secondary|Time to Tumor Progression (Overall ITT)|Time from the start of study treatment to the first documentation of objective tumor progression.|From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter|ITT||Weeks||95% Confidence Interval|Median
715099|NCT00247676|Secondary|Progression-Free Survival (ITT Child Pugh Class A Subject Population)|Time from start of study treatment to first documentation of objective tumor progression, or to death due to any cause.|From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter or death|ITT Child Pugh Class A (assessment of liver function) subject population = subjects enrolled in the study with Child-Pugh Class A that received at least 1 dose of study medication.||Weeks||95% Confidence Interval|Median
715100|NCT00247676|Secondary|Progression-Free Survival (Overall ITT)|Time from start of study treatment to first documentation of objective tumor progression, or to death due to any cause.|From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter or death|ITT||Weeks||95% Confidence Interval|Median
715101|NCT00247676|Secondary|Best Overall Response of PR or SD With Duration ≥12 Weeks|Number of patients with best overall response of PR or SD with duration ≥ 12 weeks. Best overall response was defined as the time from the first documentation of tumor response that was subsequently confirmed to the first documentation of disease progression or to death due to any cause. CR=disappearance of all target lesions. PR= ≥30% decrease in sum of longest dimensions of lesions taking as reference baseline sum longest dimensions. SD=neither shrinkage for PR or increase for PD taking as reference smallest sum of longest dimensions since treatment start.|From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter or SD with duration of at least 12 weeks or death due to cancer|ITT||participants|||Number
715121|NCT00249795|Secondary|First Occurrence of Any Heart Failure (HF) Episode|The considered event is the first occurence of any HF episode defined as evidence of signs and symptoms of HF with or without hospitalization over the duration of follow-up, as reported by the investigator (i.e. not validated by the Event Adjudication Committee).|Median follow-up of 4.5 years|The intent-to-treat (ITT) population was used for the analysis.||participants|||Number
715102|NCT00247676|Secondary|Clinical Benefit Response (CR, PR, or SD With Duration ≥12 Weeks)|Number of patients with Clinical Benefit Response: confirmed CR, confirmed PR, or SD for at least 12 weeks on study according to RECIST. CR=disappearance of all target lesions. PR= ≥30% decrease in sum of longest dimensions of lesions taking as reference baseline sum longest dimensions. SD=neither shrinkage for PR or increase for PD taking as reference smallest sum of longest dimensions since treatment start.|From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter or SD with duration of at least 12 weeks on study|ITT||participants|||Number
715103|NCT00247676|Primary|Best Overall Response|Number of subjects with best overall response. Complete response (CR)=disappearance of all target lesions. Partial Response (PR)= ≥30% decrease in sum of longest dimensions of lesions taking as reference baseline sum longest dimensions. Progressive disease (PD)= ≥ 20% increase in sum of longest dimensions of lesions taking as a reference smallest sum of the longest dimensions since treatment start, or the appearance of ≥ 1 new lesion. Stable disease (SD)=neither shrinkage for PR or increase for PD taking as reference smallest sum of longest dimensions since treatment start.|From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter|Intent-to-treat (ITT) population includes all patients enrolled in the study that received at least 1 dose of study medication.||participants|||Number
715104|NCT00247676|Secondary|Duration of Objective Response (CR or PR)|Time from the first documentation of objective tumor response (CR or PR) that was subsequently confirmed to the first documentation of disease progression or to death due to any cause. CR=disappearance of all target lesions. PR= ≥30% decrease in sum of longest dimensions of lesions taking as reference baseline sum longest dimensions.|From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter or death due to cancer|From the Overall ITT population, only 1 subject had Objective Response for evaluation of duration of objective response.||Weeks|||Number
715105|NCT00247962|Secondary|Ankylosing Spondylitis Quality of Life (ASQoL) Total Score Change From Baseline|ASQoL is a questionnaire to assess disease specific quality of life. It consists of 18 statements that are relevant to the physical and mental conditions for a patient with Ankylosing Spondylitis (AS). Each statement is answered by the patients as a “Yes” (scored as 1) or “No” (scored as 0). All item scores are summed to give a total score. Scores can range from 0 (good QoL) to 18 (poor QoL).|Baseline and 16 Weeks|The analysis population was limited to subjects whose native language was English, Hungarian and Dutch.||units on a scale||Standard Deviation|Mean
715106|NCT00247962|Primary|Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS 20)|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement from baseline and an improvement ≥ 10 units on a 0-100 scale (0=no disease activity; 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|16 weeks|All randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline efficacy evaluation. Last observation carried forward approach (LOCF) used for missing data imputations.||participants|||Number
715110|NCT00249496|Secondary|HIV Risk Behaviors|Percentage of people reporting that they traded sex for drugs or money|1 year|intent to treat||percentage of participants||Full Range|Mean
715111|NCT00249496|Secondary|Percentage of Monday, Wednesday and Friday Urine Samples That Are Negative for Opiates|"(The number of Monday, Wednesday and Friday urine samples negative for opiates/total number of urine samples) x 100.
We have not confirmed the accuracy/completeness of the Mon, Wed, Fri urine data at this point. In addition, the monthly data had less missing data than the Monday, Wednesday and Friday data and were sufficient to show the main results of the trial."|1 year|This measure was not analyzed due to limited funding to confirm the accuracy/completeness of the Mon, Wed, Fri urine data.|||||
715112|NCT00249496|Secondary|Percentage of 30-day Assessment Urine Samples Negative for Opiates|(The number of monthly urine samples negative for opiates/total number of urine samples) x 100|1 year|intent to treat||percentage of opiate negative||Full Range|Mean
715113|NCT00249496|Secondary|Percentage of Monday, Wednesday and Friday Urine Samples That Are Negative for Cocaine|"(The number of Monday, Wednesday and Friday urine samples negative for cocaine/total number of urine samples) x 100.
We have not confirmed the accuracy/completeness of the Mon, Wed, Fri urine data at this point. In addition, the monthly data had less missing data than the Monday, Wednesday and Friday data and were sufficient to show the main results of the trial."|1 year|This measure was not analyzed due to limited funding to confirm the accuracy/completeness of the Mon, Wed, Fri urine data|||||
715114|NCT00249496|Primary|Percentage of Monthly Urine Samples That Are Negative for Cocaine|The percentage of urine samples collected at monthly assessments that are negative for cocaine.|1 year|||percentage of urine samples||Full Range|Mean
715115|NCT00249613|Primary|Any Substance Use Past 30 Days|Substance use in past 30 days at 12 months post intake|12 Months|||Odds ratio||95% Confidence Interval|Number
715116|NCT00249613|Secondary|Predictors of Change in Employment at 12 Months Post Intake: Generalized Estimating Equation (GEE) Model|Predictors of change in employment at 12 months post intake: GEE - comparison of Women-Only vs. Mixed-Gender treatment models|12 month post intake|||Beta coefficient||95% Confidence Interval|Number
715117|NCT00249613|Primary|Predictors of Criminal Activity at 12 Months Post Intake||12 Months|||Odds ratio||95% Confidence Interval|Number
715118|NCT00249613|Primary|Results (Unadjusted) for Criminal Activities in Past 30 Days at Baseline and Follow-up for Women in Women-Only Treatment and Mixed-Gender Treatment||baseline and 1-year follow-up|Intention to treat (ITT)||Percentage reporting criminal activity|||Number
715119|NCT00249795|Secondary|First Hospitalisation for Other Cardiovascular (CV) Cause|The considered event is the overnight hospital stay for any CV cause other than Heart Failure over the duration of follow-up, as reported by the investigator (i.e. not validated by the Event Adjudication Committee).|Median follow-up of 4.5 years|The intent-to-treat (ITT) population was used for the analysis.||participants|||Number
715123|NCT00249795|Secondary|First Occurrence of Stroke|The considered event is the first occurrence of stroke (nonfatal or fatal, ischemic, hemorrhagic or of uncertain type) over the duration of follow-up, after validation by the EAC.|Median follow-up of 4.5 years|The intent-to-treat (ITT) population was used for this analysis.||participants|||Number
715124|NCT00249795|Primary|First Occurence of Any Component of the Composite of Myocardial Infarction, Stroke, Vascular Death or Hospitalization for Heart Failure as Per Adjudication|The second co-primary event is the first occurence of any component of the following cluster over the duration of follow-up: myocardial infarction (nonfatal or fatal), stroke (nonfatal or fatal), vascular death or hospitalization for heart failure - after validation by the EAC.|Median follow-up of 4.5 years|The intent-to-treat (ITT) population was used for this analysis.||participants|||Number
715125|NCT00249795|Primary|First Occurence of Any Component of the Composite of Myocardial Infarction, Stroke or Vascular Death as Per Adjudication|The first co-primary event is the first occurence of any component of the following cluster over the duration of follow-up: myocardial infarction (nonfatal or fatal), stroke (nonfatal or fatal) or vascular death - after validation by the Event Adjudication Committee (EAC).|Median follow-up of 4.5 years|The intent-to-treat (ITT) population was used for all analyses. This consisted of all randomized patients irrespective of whether or not the patient actually received study drug or the patient's compliance with the study protocol. All patients were included in the treatment group to which they were originally allocated.||participants|||Number
715126|NCT00249821|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs)|Adverse Events (AEs): Any untoward medical occurrence in the form of signs, clinically significant abnormalities in laboratory findings, diseases, symptoms, or worsening of complications. TEAEs: AEs that occur during treatment with the Investigational Medicinal Product (IMP).|Baseline (randomization) until Month 12|The safety population included all the participants who received at least 1 dose of study medication.||participants|||Number
715127|NCT00249821|Secondary|Insulin Like Growth Factor Binding Protein-3 (IGFBP-3) Levels||Baseline (randomization), Month 6 and Month 12|"FA set included all participants who received at least 1 dose of study medication and had at least 1 height evaluation post randomization. ‘N’ (Number of participants analyzed) signified those participants who were evaluable for this measure and n = number of participants analyzed at that particular time point for each arm group respectively."||milligram/L (mg/L)||Standard Deviation|Mean
715128|NCT00249821|Secondary|Insulin Like Growth Factor-1 (IGF-1) Levels||Baseline (randomization), Month 6 and Month 12|"FA set included all participants who received at least 1 dose of study medication and had at least 1 height evaluation post randomization. ‘N’ (Number of participants analyzed) signified those participants who were evaluable for this measure and n = number of participants analyzed at that particular time point for each arm group respectively."||microgram/liter (mcg/L)||Standard Deviation|Mean
715129|NCT00249821|Secondary|Change From Baseline in Bone Age at Month 12|Bone age was assessed by a left wrist X-Ray and evaluated by the investigator according to the Greulich and Pyle method.|Baseline (randomization) and Month 12|"FA set included all participants who received at least 1 dose of study medication and had at least 1 height evaluation post randomization. ‘N’ (Number of participants analyzed) signified those participants who were evaluable for this measure and n = number of participants analyzed at that particular time point for each arm group respectively."||years||Standard Deviation|Mean
715130|NCT00249821|Secondary|Change From Baseline in Height at Month 6||Baseline (randomization) and Month 6|FA set included all the participants who received at least 1 dose of study medication and had at least 1 height evaluation post randomization. LOCF was used to impute missing values.||cm||Standard Deviation|Mean
715131|NCT00249821|Secondary|Height Velocity-Standard Deviation Score (HV-SDS)|Height Velocity-Standard Deviation Score (HV-SDS) was calculated as height velocity minus reference mean height velocity divided by SD of the reference mean height velocity. Greater HV-SDS indicates greater height velocity.|Month 6 and Month 12|"FA set included all the participants who received at least 1 dose of study medication and had at least 1 height evaluation post randomization. Here n signifies number of participants analyzed at that particular time point for each arm group respectively. LOCF was used to impute missing values."||standard deviation score||Standard Deviation|Mean
715132|NCT00249821|Secondary|Change From Baseline in Height-Standard Deviation Score (H-SDS) at Month 6 and Month 12|Height-Standard Deviation Score (H-SDS) was calculated as height minus mean (age-and sex-matched reference) divided by standard deviation (SD) [age and sex-matched reference]. Greater H-SDS indicates greater height.|Baseline (randomization), Month 6 and Month 12|FA set included all the participants who received at least 1 dose of study medication and had at least 1 height evaluation post randomization. LOCF was used to impute missing values.||standard deviation score||Standard Deviation|Mean
715133|NCT00249821|Primary|Height Velocity|Height Velocity (HV) is the change in height since the previous year´s measurement and more precisely: HV = {(h-hp)/(d-dp)} * 365.25 [centimeter (cm)/year] where h is current height in cm, hp is previous height in cm, closest to 1 year previous, d is the current date and dp is the date of measurement of previous height, closest to 1 year previous. Additionally, d and dp have to be within 0.6 years and 1.5 years. HV is the mean height velocity over the interval between d and dp but is displayed as HV at d.|Month 12|Full Analysis (FA) set included all the participants who received at least 1 dose of study medication and had at least 1 height evaluation post randomization. Last observation carried forward (LOCF) was used to impute missing values.||centimeter (cm)/year||Standard Deviation|Mean
715134|NCT00249873|Secondary|Adjudicated Major Bleedings|The number of participants with at least one major bleeding, validated by the Event Adjudication Committee are counted over the duration of the follow-up (including after permanent discontinuation of the study drug).|expected median follow-up of approximately 3 years|The intent-to-treat (ITT) population was used for the analysis.||participants|||Number
715135|NCT00249873|Secondary|Death From Any Cause (Cardiovascular and Noncardiovascular)|The considered event is death from any cause. The analysis is performed on the time from randomization to this event. Numbers of patients with the event over the duration of the follow-up are presented by arm group.|expected median follow-up of approximately 3 years|The intent-to-treat (ITT) population was used for the analysis.||participants|||Number
715175|NCT00250679|Secondary|Mean Values for the 6-Minute Walk Test: Distance Walked in Meters|This test measures the participants' level of fitness. It is a measure of the distance the participant can walk in 6 minutes.|Baseline (Visit 2), week 13, week 26|ITT population||meters||Standard Deviation|Mean
715136|NCT00249873|Secondary|Occurrence of Stroke|The event is the occurence of stroke (nonfatal or fatal, ischemic, hemorrhagic or of uncertain type) after validation of the Event Adjudication Committee . The analysis is performed on the time from randomization to the occurrence of this event. Numbers of patients with the event over the duration of the follow-up are presented by arm group.|expected median follow-up of approximately 3 years|The intent-to-treat (ITT) population was used for this analysis.||participants|||Number
715137|NCT00249873|Primary|First Occurence of Any Component of the Composite of Stroke, Non-Central Nervous System (Non-CNS) Systemic Embolism, Myocardial Infarction or Vascular Death as Per Adjudication|"The primary event is the first occurence of any adjudicated component of the following cluster over the duration of follow-up :
stroke (nonfatal or fatal)
myocardial infarction (nonfatal or fatal)
non-CNS systemic embolism
vascular death
The primary efficacy analysis is performed on the time from randomization to this primary event. Numbers of patients with the composite event over the duration of the follow-up are presented by arm group."|expected median follow-up of approximately 3 years|The intent-to-treat (ITT) population was used for all analyses. This consisted of all randomized patients irrespective of whether or not the patient actually received study drug or the patient’s compliance with the study protocol. All patients were included in the treatment group to which they were originally allocated.||participants|||Number
715138|NCT00250276|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Month 0 to Month 12|The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at least one vaccine administration documented.||Subjects|||Number
715139|NCT00250276|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Month 0 to Month 7|The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at least one vaccine administration documented.||Subjects|||Number
715140|NCT00250276|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|Within 30 days (Day 0-29) post vaccination|The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at last one vaccine administration documented.||Subjects|||Number
715141|NCT00250276|Secondary|Number of Subjects With MSAEs|MSAEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|From Month 0 to Month 12|The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at last one vaccine administration documented.||Subjects|||Number
715142|NCT00250276|Secondary|Number of Subjects With (NOCDs)|NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.|From Month 0 to Month 12|The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at last one vaccine administration documented.||Subjects|||Number
715143|NCT00250276|Secondary|Number of Subjects With Medically Significant Adverse Events (MSAEs)|MSAEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|From Month 0 to Month 7|The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at last one vaccine administration documented.||Subjects|||Number
715144|NCT00250276|Secondary|Number of Subjects With New Onset Chronic Diseases (NOCDs)|NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.|From Month 0 to Month 7|The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at last one vaccine administration documented.||Subjects|||Number
715145|NCT00250276|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastro-intestinal, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Arthralgia (joint pain) = pain occurring in joints that were distal from the injection site. This outcome presents results across vaccination doses for solicited general symptoms.|During the 7-days (Day 0-6) post-vaccination|The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at last one vaccine administration documented.||Subjects|||Number
715157|NCT00250458|Primary|Participants With Elimination of Nausea at 2 Hours Postdose|Participants reporting the absence of nausea at 2 hours post treatment. Absence or presence of nausea was recorded by the participants in an electronic diary. Absence is defined as no nausea at 2 hours post-treatment.|At 2 hours after treatment|Full Analysis Set (FAS): The FAS population included all randomized and treated Participants who had at least one assessment within 2 hours post-dose (i.e., after baseline assessment).||Participants|||Number
715146|NCT00250276|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastro-intestinal, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Arthralgia (joint pain) = pain occurring in joints that were distal from the injection site. This outcome presents solicited general symptoms post dose 3 of vaccination.|During the 7-days (Day 0-6) post-vaccination|The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at last one vaccine administration documented.||Subjects|||Number
715147|NCT00250276|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastro-intestinal, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Arthralgia (joint pain) = pain occurring in joints that were distal from the injection site. This outcome presents solicited general symptoms post dose 2 of vaccination.|During the 7-days (Day 0-6) post-vaccination|The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at last one vaccine administration documented.||Subjects|||Number
715148|NCT00250276|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastro-intestinal, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Arthralgia (joint pain) = pain occurring in joints that were distal from the injection site. This outcome presents solicited general symptoms post dose 1 of vaccination.|During the 7-days (Day 0-6) post-vaccination|The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at least one vaccine administration documented.||Subjects|||Number
715149|NCT00250276|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) diameter of injection site.|During the 7-days (Day 0-6) post-vaccination|The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at least one vaccine administration documented.||Subjects|||Number
715150|NCT00250276|Secondary|Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18|Seropositivity defined subjects with anti-HPV-16 antibody concentration ≥ 8 EL.U/mL and/or anti-HPV-18 antibody concentration ≥ 7 EL.U/mL .|At Month 2|The According-to-Protocol cohort for immunogenicity included all evaluable subjects from whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine component at Month 2.||Subjects|||Number
715151|NCT00250276|Secondary|Number of SCR Subjects for Anti-HPV-16 and Anti-HPV-18|Seroconversion was defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (anti-HPV-16 concentrations ≥8 ELISA units per milliliter [EL.U/mL] and anti-HPV-18 concentrations ≥7 EL.U/mL) in the serum of subjects seronegative before vaccination.|At Month 2|The According-to-Protocol cohort for immunogenicity included all evaluable subjects from whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine component at Month 2.||Subjects|||Number
715152|NCT00250276|Primary|Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18|Seropositivity defined subjects with anti-HPV-16 antibody concentration ≥ 8 EL.U/mL and/or anti-HPV-18 antibody concentration ≥ 7 EL.U/mL.|At Month 7|The According-to-Protocol cohort for immunogenicity included all evaluable subjects from whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine component at Month 7.||Subjects|||Number
715153|NCT00250276|Primary|Number of Seroconverted (SCR) Subjects for Anti-Human Papillomavirus Type 16 (Anti-HPV-16) and Anti-Human Papillomavirus Type 18 (Anti-HPV-18)|Seroconversion was defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (anti-HPV-16 concentrations ≥8 Enzyme-Linked Immunosorbent Assay [ELISA] units per milliliter [EL.U/mL] and anti-HPV-18 concentrations ≥7 EL.U/mL) in the serum of subjects seronegative before vaccination.|At Month 7|The According-to-Protocol cohort for immunogenicity included all evaluable subjects from whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine component at Month 7.||Subjects|||Number
715154|NCT00250432|Secondary|Number of Patients With a Favorable Overall Response.|"Number of patients with a favorable overall response, defined as a clinical response of cure or apparent cure along with a microbiological response of eradication or presumptive eradication at the End of Caspofungin Therapy."|90 Days|Full Analysis Set (FAS): Included those patients who received at least 1 full dose of caspofungin study therapy and had a documented diagnosis of invasive candidiasis from a sterile, invasive body site, as defined in the protocol.||Participants|||Number
715155|NCT00250432|Primary|Number of Patients Who Develop Significant Drug-related Adverse Events.|Number of patients with at least 1 significant drug-related adverse event (serious drug-related or drug-related adverse events leading to caspofungin discontinuation) while on caspofungin study therapy or during the immediate 14-day post-caspofungin therapy period.|90 Days|All patients as treated population||Participants|||Number
715156|NCT00250458|Secondary|Participants With Pain Relief at 2 Hours Postdose|Participants reporting pain relief defined as a reduction of pain severity from grades 2 or 3 (moderate or severe pain) at baseline to grades 0 or 1 (no headache or mild pain) at 2 hours after treatment.|2 hours after treatment|Full Analysis Set (FAS): The FAS population included all randomized and treated Participants who had at least one assessment within 2 hours post-dose (i.e., after baseline assessment).||Participants|||Number
715161|NCT00250497|Secondary|Body Satisfaction|Ten questions assessing satisfaction with weight, height, and specific parts of the body; six Likert response categories.Body Satisfaction Scale Range=10-60 with higher values indicating increased body satisfaction.|One year|||units on a scale||Standard Deviation|Mean
715162|NCT00250497|Secondary|Unhealthy Weight Control Behaviors|Ten questions assessing use of unhealthy weight control behaviors in the past month (yes/no). Behavior categories included fasted, ate very little, took diet pills, made myself vomit, used laxatives, used diuretics, used food substitutes, skipped meals, smoked more cigarettes, and went on a diet. If a respondent reported doing any of these behaviors, they were classified as having used unhealthy weight control behaviors.|One Year|||percentage of participants|||Number
715163|NCT00250497|Secondary|Sedentary Activity|The 3DPAR assessed the sedentary behaviors and physical activities that study participants engaged in during each half hour time block between 6 AM and midnight on the three days previous to the day of data collection. In order to complete the 3DPAR, participants were provided with a list of 65 common sedentary behaviors and physical activities and were asked to select the activity that they participated in for the majority of every 30-minute block. The number of blocks of sedentary activity were summed for each day and then averaged over the 3 days. Outcomes was the average # of 30 minute blocks of sedentary activity per day|One Year|||average number of 30-minute blocks/day||Standard Deviation|Mean
715164|NCT00250497|Secondary|Fruits and Vegetables||One year|||Servings/day||Standard Deviation|Mean
715165|NCT00250497|Secondary|Level of Physical Activity|The 3DPAR assessed the sedentary behaviors and physical activities that study participants engaged in during each half hour time block between 6 AM and midnight on the three days previous to the day of data collection. In order to complete the 3DPAR, participants were provided with a list of 65 common sedentary behaviors and physical activities and were asked to select the activity that they participated in for the majority of every 30-minute block. The number of blocks of physical activity were summed for each day and then averaged over the 3 days. Outcomes was the average # of 30 minute blocks of physical activity.|One year|||average number of 30-minute blocks/day||Standard Deviation|Mean
715166|NCT00250497|Primary|Percent Body Fat|Measured with DEX-A at baseline and 1 year follow-up|Baseline and One year|||% body fat (DXA)||Standard Deviation|Mean
715167|NCT00250588|Secondary|Asthma Symptoms|Asthma symptom frequency was measured via the number of days and nights with asthma symptoms over the past two weeks. Night time asthma symptoms were converted to number of subjects experiencing night time asthma symptoms more than 1 time per week.|Baseline (T1), Post Intervention (3mo, T2), 6-month follow up (9mo post baseline, T3)|All analyses were intent-to-treat and carried out according to a pre-established plan using SAS 9.1.3. All subjects with data at T2 or T3 were included in the analyses.||participants|||Number
715168|NCT00250588|Secondary|Counts of Patients With One or More Asthma-related Emergency Department Visits.|Utilization was measured by parent recall of emergency room visits for asthma over the last 6 months (at T1), 3 months (at T2), and 6 months (at T3).|Baseline (T1), Post Intervention (3mo, T2), 6-month follow up (9mo post baseline, T3)|All analyses were intent-to-treat and carried out according to a pre-established plan using SAS 9.1.3.||participants|||Number
715169|NCT00250588|Primary|Parent Proxy-Reported Health-related Quality of Life (Pediatric Quality of Life Inventory)|The PedsQL™ 4.0 Generic Core Scales Total Scale Score (PedsQL™), which has been shown to be internally consistent, valid, and responsive to indicators of clinical change for children with asthma (Chan, Mangione-Smith, Burwinkle, Rosen, & Varni, 2005; Seid et al., in press; Varni et al., 2004). The 23-item PedsQL™ asks respondents how often various issues have been a ‘problem’ in the past month, yields a score of 0 to 100 (higher scores are better), and includes parallel child self-report (ages 5-18 years) and parent proxy-report (ages 2-18 years) forms. We measured both self- and proxy-report, although our a priori primary outcome was parent proxy-report.|Baseline (T1), Post Intervention (3mo, T2), 6-month follow up (9mo post baseline, T3)|All analyses were intent-to-treat and carried out according to a pre-established plan using SAS 9.1.3. All subjects with data at T2 or T3 were included in the analyses.||units on a scale||Standard Error|Mean
715170|NCT00250679|Secondary|Mean Values for Forced Expiratory Volume in One Second (FEV1)|Forced Expiratory Volume in one second|Baseline (Visit 2), weeks 3, 13, 26|||Liters||Standard Deviation|Mean
715171|NCT00250679|Secondary|Mean Values for Inspiratory Capacity|Inspiratory capacity is the maximum volume that can be inhaled.|Baseline (Visit 2), Weeks 3, 13, 26|||Liters||Standard Deviation|Mean
715172|NCT00250679|Secondary|Mean Values for Subject Global Evaluations|The subject global evaluation is reported by study subjects/participants. It is a COPD symptoms rating ranging from 1 to 7, with 1 = much better and 7 = much worse.|Baseline (Visit 2), weeks 13, 26|ITT Population||units on a scale||Standard Deviation|Mean
715173|NCT00250679|Secondary|Mean Values for St. George's Respiratory Questionnaire|A questionnaire to assess respiratory health. Scores are expressed as a percentage of overall impairment (total score), where 100 represents the worst possible health status and 0 indicates best possible health status.|Baseline (Visit 2), weeks 13, 26|ITT population||units on a scale||Standard Deviation|Mean
715174|NCT00250679|Secondary|Mean Values for Investigator Global Evaluations|The investigator global evaluation is reported by the study investigator. It is a COPD symptoms rating ranging from 1 to 7, with 1 = much better and 7 = much worse.|Baseline (Visit 2), Weeks 13, 26|ITT population||units on a scale||Standard Deviation|Mean
715176|NCT00250679|Secondary|Percent (%) of Participants With a >=4 Unit Improvement in the St. George's Respiratory Questionaire|Percent of participants with a >=4 unit improvement in the overall impairment (total score) of the St. George's Respiratory Questionaire. This questionaire uses a 100 - 0 scale, where 100 represents the worst possible health status and 0 indicates the best possible health status.|visit 4 (week 13), visit 5 (week 26)|ITT population||percent of participants|||Number
715177|NCT00250679|Secondary|Percent (%) of Participants With an Improved Transitional Dyspnea Index|The percentage of participants with a transitional focal score (range -9 to 9) of >=1 improvement. Transitional focal score is the sum of the Functional Impairment, Magnitude of Task, and Magnitude of Effort scores. A score of -9 is maximum worsening and 9 is maximum improvement.|visits 4 (week 13), visit 5 (week 26)|"ITT population. Percentages were based on the number of subjects with non-missing data.
Visit 4 n=115, 113, 114 Visit 5 n=108, 102, 103"||percent of participants|||Number
715178|NCT00250679|Secondary|Modified Medical Research Council Dyspnea Questionaire|Scores range from 0 to 4, with a score of 4 indicating that a subject is too breathless to leave the house or becomes breathless when dressing or undressing. The highest numbered question to which the subject answered 'Yes' is the Dyspnea Scale Score.|Baseline (visit 2), weeks 13, 26|ITT Population||units on a scale||Standard Deviation|Mean
715179|NCT00250679|Secondary|Number of Participants With a >=4 Unit Improvement on the St. George's Respiratory Questionnaire|Scores are expressed as the number of participants with >= 4 unit improvement in overall impairment (total score), where 100 represents worst possible health status and 0 indicates best possible health status.|Visit 4 (week 13) , Visit 5 (week 26)|ITT Population||Participants|||Number
715180|NCT00250679|Secondary|Mean Change From Baseline in St. George's Respiratory Questionnaire|Scores are expressed as a mean change from baseline of overall impairment (total score). The questionnaire has a scale of 100 which represents worst possible health status to 0 which indicates best possible health status.|weeks 13, 26|ITT Population||units on a scale||95% Confidence Interval|Mean
715181|NCT00250679|Secondary|6-Minute Walk: Change From Baseline in the Distance Walked in 6 Minutes|Mean change from baseline in distance walked (meters)|Post-Dose weeks 0, 13, 26|ITT Population||meters||95% Confidence Interval|Mean
715182|NCT00250679|Secondary|BODE Index|The BODE index (0=relative health and 10=severe chronic obstructive pulmonary disease) is a multi-dimension COPD grading system that incorporates body-mass index (B), degree of airflow obstruction (O), dyspnea (D), and exercise capacity (E) as measured by the 6-minute walk test. Scores were derived using pre-dose assessments from each visit.|Baseline (visit 2), weeks 13, 26|ITT Population||units on a scale||Standard Deviation|Mean
715183|NCT00250679|Secondary|Investigator Global Evaluations Change From Baseline|The global evaluation is a COPD symptoms rating ranging from 1 to 7, with 1 = much better and 7 = much worse. Ratings were assessed relative to the subject's initial entry into the study.|weeks 13, 26|ITT Population||units on a scale||95% Confidence Interval|Mean
715184|NCT00250679|Secondary|Subject Global Evaluations Change From Baseline|The global evaluation is a COPD symptoms rating ranging from 1 to 7, with 1=much better and 7=much worse. Ratings were assessed relative to the subject's initial entry into the study.|weeks 13, 26|ITT Population||units on a scale||95% Confidence Interval|Mean
715185|NCT00250679|Secondary|Forced Expiratory Volume in One Second (FEV1) Changes From Baseline for 24 Hour Post Dose Timepoint (Trough)|The 24 hour trough is the FEV1 value obtained 24 hours post first dose. This value is compared to the baseline FEV1 value.|weeks 0,3,13,26|ITT Population||Liters||95% Confidence Interval|Mean
715186|NCT00250679|Secondary|Number of Participants With an Improved Transitional Dyspnea Index|The number of participants with a transitional focal score (range -9 to 9) of >=1 improvement. Transitional focal score compares current health against baseline for the Functional Impairment, Magnitude of Task, and Magnitude of Effort scores. A score of -9 is maximum worsening and 9 is maximum improvement.|weeks 13, 26|ITT Population. Visit 4 n=115,113,114 Visit 5 n=108,102,103||Participants|||Number
715187|NCT00250679|Secondary|Transitional (Relative Change in) Dyspnea Index|The transitional focal score (-9 to 9) is the sum of relative change from baseline for the Functional Impairment, Magnitude of Task, and Magnitude of Effort scores (each -3 to 3 scale). A Transitional Dyspnea Index score of -9 represents a maximum degradation of all three tests; a score of 9 represents a maximum improvement of all three tests.|weeks 13, 26|ITT Population||units on a scale||95% Confidence Interval|Mean
715188|NCT00250679|Secondary|Time-Normalized Area Under the Curve (nAUC) From 0 to 6 Hrs for Forced Expiratory Volume in One Second (FEV1) Changes From Baseline|Area under the change from baseline curve from 0 to 6 hours. Time-normalized AUC (0-6 hrs) was derived using the linear trapezoidal method.|weeks 0,3,13,26|ITT Population. Spirometry measurements collected within 6 hours following in-clinic rescue/supplemental medications use were excluded from analysis.||Liter||95% Confidence Interval|Mean
715189|NCT00250679|Secondary|Racemic Albuterol or Levalbuterol Metered Dose Inhaler (MDI) Usage: Number of Actuations Per Day|Rescue medication usage during the study. MDI stands for metered dose inhaler. An actuation is one depression of the device that releases medication.|Screening (day-14 to 0) and Treatment (week 0 - 26)|ITT Population||Actuations/Day||95% Confidence Interval|Mean
715190|NCT00250679|Secondary|Racemic Albuterol or Levalbuterol Metered Dose Inhaler (MDI) Usage: Days Used Per Week|Rescue medication usage during the study. MDI stands for metered dose inhaler.|Screening (day-14 to 0) and Treatment (week 0 - 26)|ITT Population||Days Used / Week||95% Confidence Interval|Mean
715191|NCT00250679|Secondary|Ipratropium Bromide Metered Dose Inhaler (MDI) Usage: Number of Actuations Per Day|Supplemental medication usage during the study. MDI stands for metered dose inhaler. An actuation is one depression of the device that releases medication.|Screening (day-14 to 0) and Treatment (week 0 - 26)|ITT Population||Actuations / Day||95% Confidence Interval|Mean
715192|NCT00250679|Secondary|Ipratropium Bromide Metered Dose Inhaler (MDI) Usage: Days Used Per Week|Supplemental medication usage is recorded throughout the study. MDI stands for metered dose inhaler.|Screening (day-14 to 0) and Treatment (week 0 - 26)|ITT Population||Days Used / Week||95% Confidence Interval|Mean
715193|NCT00250679|Secondary|Number of Participants With Potentially Clinically Significant Heart Rate|Number of subjects with a heart rate that was lower/higher than a set limit and increased/decreased from set baseline limit in beats per minute (bpm)|visit 6 (week 27)|||Participants|||Number
715594|NCT00248781|Primary|Knee Extension Strength|The peak force measured during the bilateral knee extension exercise against the highest level of a hydraulic resistance system|6 months|number of subjects completing 6 month evaluations||kg||Standard Deviation|Mean
715194|NCT00250679|Secondary|6-Hour Peak Changes From Baseline in Forced Expiratory Volume (FEV1)|The 6 hour peak change from baseline is the maximum of the post-dose change values through 6 hours at each visit.|weeks 0,3,13,26|ITT population. An available cases analysis was performed with no imputation for missing data.||Liter||95% Confidence Interval|Mean
715195|NCT00250679|Secondary|Inspiratory Capacity Changes From Baseline|Mean Change in Inspiratory Capacity values from baseline (baseline assessment obtained at Visit 2, pre-dose). Spirometry measurements collected within 6 hours following in-clinic rescue/supplemental medications use were excluded from analysis.|weeks 0,3,13,26|ITT Population This outcome was added as an amendment after the study was initiated; therefore approximately half of the ITT population had these assessments at baseline. An available cases analysis was performed with no imputation for missing data.||Liter||95% Confidence Interval|Mean
715196|NCT00250679|Secondary|Number of Participants With New 12-Lead Electrocardiogram (ECG) Alerts|New Electrocardiogram (ECG) alerts are defined as those alerts that occurred post-treatment and were not present at baseline.|visit 6 (week 27)|ITT Population||Participants|||Number
715197|NCT00250679|Secondary|Number of Participants With Potentially Clinically Significant Potassium Evaluations|Patients with potassium values that met low (<=3 mEq/L) or high (>=6 mEq/L) criteria were considered potentially clinically significant.|visit 6 (week 27)|ITT Population||Participants|||Number
715198|NCT00250679|Secondary|Number of Participants With Potentially Clinically Significant Glucose Evaluations|Patients with glucose values that met low (<=40 mg/dL) or high (>=175 mg/dL) criteria were considered potentially clinically significant.|visit 6 (week 27)|ITT Population||Participants|||Number
715199|NCT00250679|Secondary|Number of Participants With New 24-Hour Holter Monitoring Alerts|New holter monitoring alerts are defined as those alerts that occurred post-randomization and were not present at baseline.|Visit 6 (week 27)|ITT Population||Participants|||Number
715200|NCT00250679|Primary|Percent (%) of Participants With Adverse Events (AEs), in Particular COPD Exacerbations|"Percent of participants with the adverse event specified.
SOC = system organ class."|Six months|ITT Population||percent of participants|||Number
715201|NCT00250705|Secondary|Secondary Outcome Measures Were the Clinical Global Impression--Improvement (CGI-I) Scales (NIMH, 1985a).|The Clinical Global Impression – Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1. Very much improved; 2. Much improved; 3. Minimally improved; 4. No change; 5. Minimally worse; 6. Much worse; or 7. Much worse)|6 weeks|||units on a scale||Standard Deviation|Mean
715202|NCT00250705|Primary|Children's Aggression Scale-Parent Version|"CAS-P is a 33 item scale representing 5 domains of aggression: Items in a domain were computed based on two reference points. The first was based on a 5 point frequency range with 0 being best (never) and 4 (> 10 times being) worst. These same items were then adjusted such that more severe acts would be weighted more heavily compared to less severe aggressive behaviors. Within a domain, 0 was the best score. Worst score for the various aggression domains were: Verbal 26.16, Against Objects and Animals 11.8, Provoked 15.84, Initiated 17.84, and Use of Weapons 13.16."|6 weeks|ITT||units on a scale||Standard Deviation|Mean
715203|NCT00250705|Secondary|Secondary Outcome Measures Were the Clinical Global Impression-Severity (CGI-S) Scale (NIMH, 1985a).|The Clinical Global Impression – Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Possible ratings are: 1. Normal, not at all ill; 2. Borderline mentally ill, 3. Mildly ill; 4. Moderately ill; 5. Markedly ill; 6. Severely ill; or 7. Among the most extremely ill patients.|6 weeks|||units on a scale||Standard Deviation|Mean
715204|NCT00250705|Primary|Overt Aggression Scale-Modified (OAS-M)|"OAS-M divides aggressions into 4 subtypes: 1) verbal aggression, 2) property aggression, 3) self aggression (autoaggression), and 4) physical aggression. Each subtype has an initial score ranging from 0 (least aggressive) to 4 (most aggressive). The score for each subscale is further weighed (multiplied) by a constant: verbal scale's constant is 1 (max adjusted score of 4); property scale's constant is 2 (max adjusted score 8); self scale's constant is 3 (max adjusted score 12); and physical scale's constant is 4 (max adjusted score of 16). Within a given scale, 0 is the best score and maximum adjusted scale score is worst."|6 weeks|ITT||units on a scale||Standard Deviation|Mean
715205|NCT00250705|Primary|The Primary Outcome Efficacy Measure: Rating of Aggression Against People and/or Property Scale (RAAPP) (Kemph et al 1993)|Rating of Aggression Against People and/or Property Scale (RAAPP) (Kemph et al 1993) is a global rating scale of aggression completed by clinicians. Score given based on following severity scale with subject assigned 1 number: Intolerable behavior-frequently physically attacks others and destroys property (5); Severe-occasionally physically attacks people and destroys property (4); Moderately 21); and No aggressiveness reported (1). A minimum score of 1 is best and a maximum score of 5 is worst. There are no subscale scores.|6 weeks|ITT||units on a scale||Standard Deviation|Mean
715206|NCT00250718|Secondary|Toxicity||End of 2 cycles (cycle = 28 days)|Trial was terminated early due to low accrual; no data to report. Adverse event data for enrolled patients is reported in the adverse event results section.|||||
715207|NCT00250718|Primary|Overall Response Rate (ORR), the Sum of Complete and Partial Responses|"Solid tumor response is per Response Evaluation Criteria in Solid Tumors (RECIST) (ver 1.0).
For CLL: complete remission (CR) requires the following for>=2 months 1) no symptoms attributable to CLL, 2) normal physical examination, 3) absolute lymphocyte count<4,000/µL, 4) ANC>1,500/µL, 5) platelets>100,000/µL, 6) hemoglobin>11 g/dL, 7) bone marrow lymphocytosis<30%, 8) no nodules in bone marrow. Partial response (PR) requires the following for >=2 months 1) decrease in previously enlarged nodes, spleen, and liver by >=50%, 2) ANC>=1,500/µL or platelets>=100,000/µL, 3) hemoglobin>=11 g/dL, 4) 50% improvement over pre-therapy reductions in hemoglobin and/or platelets.
For MM, CR is no monoclonal protein (M-protein) in blood and urine and <5% plasma cells in bone marrow on >=2 determinations >=6 wk apart & stable bone disease & calcium levels. PR is>50% and >90% decreases in serum & urine M-protein, respectively, on >=2 occasions for >=6 wk, stable bone disease & calcium."|Up to 6 months after first on-study treatment|Trial was terminated due to low accrual; no data to report. An insufficient number of subjects were accrued to report data accurately.|||||
715208|NCT00250835|Secondary|Pelvic Local Control Rate|Pelvic local control rate is defined as the proportion of subjects who have no evidence of pelvic recurrence (by standard clinical assessment, including CT scan and clinical examination) at the final follow-up evaluation, out of all evaluable patients|Up to 3 years after surgery|||percentage of evaluable participants|||Number
715209|NCT00250835|Secondary|Surgical Downstaging Rate|Downstaging rate after neoadjuvant treatment with combination oxaliplatin, capecitabine, celecoxib and concurrent radiation is defined as the proportion of patients whose pathological stage (stage at surgery) is different from their clinical stage (stage at baseline)|At surgery (up to 6 weeks after treatment)|||percentage of evaluable participants||95% Confidence Interval|Number
715210|NCT00250835|Secondary|Incidence of Sphincter-sparing Surgery|Incidence of sphincter-saving surgery is defined as the proportion of subjects who do not have permanent colostomy at the final follow-up out of all evaluable patients.|At surgery (up to 6 weeks after end of treatment)|||percentage of evaluable participants||95% Confidence Interval|Number
715211|NCT00250835|Secondary|Progression-free Survival (PFS)|"The Response Evaluation Criteria In Solid Tumors (RECIST) guidelines (Version 1.0) will be used to determine tumor response and progression. Progressive disease (PD) for target lesions: >= 20% increase in the sum of diameters of the target lesions taking as reference the smallest sum on study, and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered . PD for non-target lesions is defined as unequivocal appearance of one or more new malignant lesions or unequivocal progression of existing non-target lesions. Time to progression will be measured from the time of surgery or clinically documented down staging if surgery for whatever reason is not carried in the subject until there is evidence of PD.
Progression-free survival is reported as the percentage of patients who have not experienced progression of disease at three years post-surgery"|3 years after surgery|||percentage of evaluable participants||95% Confidence Interval|Number
715212|NCT00250835|Secondary|Toxicity|"All toxicities encountered during the study will be evaluated according to the grading system (0-5) NCI CTCAE (Common Terminology Criteria for Adverse Events) version 3.0.
Toxicity will be reported as the proportion of subjects experiencing Grades 3,4, and 5 adverse events (AEs) out of all evaluable patients"|Up to 3 years|||percentage of participants|||Number
715213|NCT00250835|Primary|Pathologic Complete Response (PCR)|The pathologic complete response (PCR) rate will be calculated as the proportion of patients who achieve complete response out of all evaluable patients. PCR is defined as the total absence of residual tumor cells by microscopic examination of the resected surgical specimen, including all of the sampled lymph nodes.|At surgery (up to 6 weeks after end of treatment)|Patients who continue on at least two of the three drugs for a minimum of 14 days are considered evaluable for the primary objective||percentage of evaluable participants||95% Confidence Interval|Number
715214|NCT00250926|Primary|Time to Progression|Progressive Disease (PD) will be defined as a greater than 25% increase in serum IgM monoclonal protein levels from the lowest attained response value as determined by serum electrophoresis, confirmed by at least one other investigation, or progression of clinically significant disease related symptom(s).|42 months|The median time to progression was not achieved as follow-up ended before half the participants had a PD event.||months||Full Range|Median
715215|NCT00250926|Primary|Time to Best Response||33.2 months|||Months||Full Range|Median
715216|NCT00250926|Primary|Response Rate|"This outcome measure was to determine the response rate along with attainment of stable disease and time to disease progression following treatment with this patient population. The response rates were defined as follows.
A complete response (CR) was defined as having resolution of all symptoms, normalization of serum IgM levels with complete disappearance of IgM paraprotein by immunofixation, absence of bone marrow disease by bone marrow biopsy and aspiration, and resolution of any adenopathy or splenomegaly. A near complete response (nCR) was defined as fulfilling all CR criteria in the presence of a positive immunofixation study. Patients with very good partial response (VGPR), partial response (PR), and minor response (MR) were defined as having a ≥ 90%, ≥ 50%, and 25% to 49% reduction in serum IgM levels, respectively. Progressive disease (PD) occurred when a more than 25% increase in serum IgM level or progression of clinically significant disease parameters was observed."|33.2 months|all enrolled patients||participants|||Number
715217|NCT00250926|Primary|Number of Participants With Adverse Events|This outcome measure was to assess the safety and tolerability of bortezomib, dexamethasone and rituximab in patients with untreated Waldenstroms macroglobulinemia.|33.2 months|All enrolled patients||participants|||Number
715218|NCT00251004|Secondary|Non-inferiority Analysis of Renal Function, Calculated by Glomerular Filtration Rate (cGFR) Using Modification of Diet in Renal Disease (MDRD) Formula|"Modification of Diet in Renal Disease (MDRD) formula is:
GFR [mL/min/1.73m^2] = 186.3*(C^-1.154)*(A^-0.203)*G*R where
C is the serum concentration of creatinine [mg/dL],
A is patient age at sample collection date [years],
G=0.742 when gender is female, otherwise G=1,
R=1.21 when race is black, otherwise R=1"|at 12 months|Intention to treat (ITT) population.||mL/min/1.73m^2|||Number
715219|NCT00251004|Primary|Non-inferiority Analysis on Percentage of Participants With Composite Efficacy Endpoints|The primary efficacy endpoint was the 12 month analysis of primary efficacy failure defined as a composite endpoint including treated biopsy proven acute rejection (BPAR), graft loss, death or loss to follow-up. In the definition of composite efficacy failure, loss to follow-up includes patients who did not experience treated BPAR, graft loss or death on or after day 1 and whose last day of contact was prior to day 316, the start day of the 12 month visit window.|12 months|Intention-to-treat population||Percentage of Participants|||Number
715220|NCT00251004|Secondary|Percentage of Participants With the Composite Incidence of Graft Loss, Death or Loss to Follow up at 12 Months Post-transplantation|"Graft loss was defined as graft loss (the allograft was presumed to be lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis) and re-transplant.
A loss to follow-up patient in the composite endpoint of graft loss, death or loss to follow-up (the main secondary efficacy endpoint) was a patient who did not experience graft loss or death from day 1 and whose last day of contact was prior to study day 316."|12 months|Intention-to-treat (ITT) population.||Percentage of participants|||Number
715221|NCT00251004|Primary|Number of Participants With Composite Efficacy Endpoints - 12 Month Analysis|The primary efficacy endpoint was the 12 month analysis of primary efficacy failure defined as a composite endpoint including treated biopsy proven acute rejection (BPAR), graft loss, death or loss to follow-up. A treated BPAR episode was defined as a biopsy graded IA, IB, IIA, IIB, or III that was treated with anti-rejection therapy. Graft loss was defined as the allograft was presumed to be lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis as well as re-transplant.|12 months|Intention-to-treat (ITT) population||Participants|||Number
715222|NCT00251225|Secondary|Overall Survival (OS)|OS is the amount of time in months from the date of registration to the date of death from any cause.|Up to 60 months|Patients with hormone refractory prostate cancer who received at least 1 cycle of Docetaxel + Imatinib||months||95% Confidence Interval|Median
715223|NCT00251225|Secondary|Prostate-Specific Antigen (PSA) Response Rate|PSA response rate is the number of participants who experienced a best response of: complete response, CR (PSA less than or equal to 0.2 ng/mL, documented two or more times, a minimum of four weeks apart), partial response, PR (a decline in PSA by at least 50%, confirmed by a second PSA value four or more weeks later) or stable disease (does not qualify for CR, PR, Progression or Symptomatic Deterioration, at least 6 weeks after registration) / total number of analyzable patients.|Up to 12 months|Patients with hormone refractory prostate cancer who received at least 1 cycle of Docetaxel + Imatinib||percentage of patients|||Number
715224|NCT00251225|Primary|Overall Time To Progression (TTP)|TTP is the amount of time from date of registration to date of first documentation of progression or symptomatic deterioration. For progression, one or more of the following must occur: (1) 20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline. (2) Increase in PSA by at least 25% from baseline in patients whose PSA did not decrease, and of 50% from nadir in patients whose PSA decreased with a confirmation 3 weeks later. (3) Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided). (4) Appearance of any new lesion/site. (5) Death due to disease without prior documentation of progression and without symptomatic deterioration, which is defined as global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.|Up to 24 months|Patients with hormone refractory prostate cancer who received at least 1 cycle of Docetaxel + Imatinib||months||95% Confidence Interval|Median
715225|NCT00251238|Primary|Change From Baseline in Severity of Vasospastic Attacks|"Severity of the complains due to Vasospastic Attacks was measured using a 10-steps likert scale.
The scale ranged between 0 and 10, with higher scores indicating more severe attacks."|Baseline and 10 weeks|||units on a scale||Standard Deviation|Mean
715226|NCT00251238|Primary|Duration of Vasospastic Attacks||minutes per day|||minutes||Standard Deviation|Mean
715227|NCT00251238|Primary|Frequency of Vasospastic Attacks||Number of Vasospastic Attacks per day, for up to 10 weeks|||attacks per day||Standard Deviation|Mean
715228|NCT00251303|Primary|Children's Yale-Brown Obsessive-Compulsive Scale Scores (CY-BOCS)|CY-BOCS is a 0-40 point scale of obsessive-compulsive symptom severity, higher number indicates more severe obsessive-compulsive symptoms. Comparison of 12 weeks scores for placebo and riluzole groups.|12 weeks|||units on a scale||Standard Deviation|Mean
715229|NCT00251303|Primary|Much/Very Much Improved on Clinical Global Impressions - Improvement Score (CGI-I)||12 weeks|||participants|||Number
715230|NCT00251316|Primary|The Rate of Successful Thyroid Ablation as Defined by Negative Recombinant Human Thyrotropin (rhTSH) Stimulated Radioiodine Whole Body Scan (RAI WBS) at 1 Year.||1 year|||Participants|||Number
715231|NCT00251589|Secondary|Progression-free Survival|Progression-free survival was measured from the start of the treatment to the time when the criteria for progression was met or death due to any cause (whichever is first recorded).|Day 1 to disease progression or death|"All patients as treated population with post-baseline data available to determine progression free survival.
Cohort A, Dose Level 1 (Amended), Cohort B, Dose Level 2 and Cohort A, Dose Level 1 (Original) are not represented in the below table as post-baseline data were not available to determine progression free survival."||Days||Full Range|Mean
715232|NCT00251589|Secondary|Disease Progression After Week 8 Based on Response Criteria in Solid Tumors (RECIST)|First documentation of Progressive Disease (PD) occurring > 8 weeks on study.|Every 57 days beginning with Cycle 3 (Week 8), or more frequently if appropriate|All patients as treated population with post-baseline data available to determine Disease Progression After Week 8.||Participants|||Number
715233|NCT00251589|Secondary|Progressive Disease (PD) as Best Response Based on Response Criteria in Solid Tumors (RECIST)|Progressive disease is defined as a ≥20% increase in the sum of the longest diameter, the appearance of one or more new lesions and/or unequivocal progression of non-target lesions by conventional or spiral CT or MRI|Every 57 days beginning with Cycle 3, or more frequently if appropriate|All patients as treated population with post-baseline data available to determine Progressive Disease as Best Response.||Participants|||Number
715234|NCT00251589|Secondary|Stable Disease (SD) as Best Response Based on Response Criteria in Solid Tumors (RECIST)|Stable disease is defined as less than a radiographic partial response, but not progressive disease|Every 57 days beginning with Cycle 3, or more frequently if appropriate|All patients treated population with post-baseline data available to determine Stable Disease as Best Response.||Participants|||Number
715235|NCT00251589|Post-Hoc|Dose Limiting Toxicity Occurring in Cycles 2 and Beyond of the Phase II Portion of the Study|Adverse event(s) that determined the treatment dose level was not tolerable for that patient in Cycles 2 and beyond of the Phase II portion of the study.|After day 28 in the Phase II portion of the study|All patients as treated population in Cycles 2 and beyond of the Phase II portion of the study.||Participants|||Number
715236|NCT00251589|Primary|Dose Limiting Toxicity Occurring in Cycle 1 of the Phase II Portion of the Study|Adverse event(s) that determined the treatment dose level was not tolerable for that patient in Cycle 1 of the Phase II portion of the study.|Day 1 to 28 in the Phase II portion of the study|All patients as treated population in Cycle 1 of the Phase II portion of the study.||Participants|||Number
715237|NCT00251589|Secondary|Unconfirmed Partial Response (UPR) Based on Response Criteria in Solid Tumors (RECIST)|An unconfirmed partial response is defined as a partial response that has not been confirmed by a follow up CT scan (or MRI) at least 4 weeks after the criteria for response are first met. (A partial response is defined as an at least 30% reduction in the sum of the longest diameter of the target lesions. Non-target lesions must be at least stable)|Every 57 days beginning with Cycle 3, or more frequently if appropriate|All patients as treated population with post-baseline data available to determine Unconfirmed Partial Response as Best Response.||Participants|||Number
715238|NCT00251589|Primary|Dose Limiting Toxicity (DLT) Occurring in Cycle 1 of the Phase I Portion of the Study|Adverse event(s) that determined the treatment dose level was not tolerable for that patient in Cycle 1 of the Phase I portion of the study.|Day 1 to 28 in the Phase I portion of the study|All patients as treated population in Cycle 1 of the Phase I portion of the study.||Participants|||Number
715239|NCT00251641|Secondary|Proportion of Participants Who Achieved a PGA Score of Cleared or Minimal at Week 26|PGA is assessed relative to baseline condition and is defined as: clear (100% clear; some residual pinkness or pigmentation: Wornoff's ring may be present), excellent/minimal (75-99% clearing; marked improvement: nearly normal skin texture; some erythema may be present), good (50-74% clearing; moderate improvement: plaque has cleared to point of small scattered papules with normal intervening epidermis), fair (25-49% clearing; slight improvement: decrease in scaling and softening of plaque), poor (0-24% clearing; little or no change in scaling, erythema, or plaque elevation), or worse (worse).|26 weeks|ITT||Proportion of participants|||Number
715240|NCT00251641|Secondary|Proportion of Participants Who Achieved a Physician's Global Assessment (PGA) Score of Cleared or Minimal at Week 16|PGA is assessed relative to baseline condition and is defined as: clear (100% clear; some residual pinkness or pigmentation: Wornoff's ring may be present), excellent/minimal (75-99% clearing; marked improvement: nearly normal skin texture; some erythema may be present), good (50-74% clearing; moderate improvement: plaque has cleared to point of small scattered papules with normal intervening epidermis), fair (25-49% clearing; slight improvement: decrease in scaling and softening of plaque), poor (0-24% clearing; little or no change in scaling, erythema, or plaque elevation), or worse (worse).|16 weeks|ITT||Proportion of participants|||Number
715241|NCT00251641|Secondary|PASI75 Response at Week 26|PASI75 response is defined as the proportion of participants who achieved at least a 75% improvement in PASI score from Baseline.|26 weeks|Intent-to-treat||Proportion of participants|||Number
715242|NCT00251641|Primary|Psoriasis Area and Severity Index 75 (PASI75) Response at Week 16.|PASI75 response is defined as the proportion of participants who achieved at least a 75% improvement in PASI score from Baseline.|16 weeks|All subjects who were randomized were included in the efficacy analysis (intent-to-treat [ITT]).||Proportion of participants|||Number
715243|NCT00251693|Secondary|Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 4 as Assessed by Endoscopy - Life Table Method.|Percentage of subjects with complete healing of EE as assessed by endoscopy was analyzed for change in LA Esophagitis Classification grades A, B, C, or D to healed. Healed is defined as anything that is less than the criterion for Grade A. If it doesn’t meet the A criterion, it’s counted as healed.|4 Weeks|In addition to the ITT subjects who had at least 1 post-baseline endoscopy, Life Table Method included the ITT subjects without any post-baseline endoscopy within 7 days of the last day of study drug as censored.||Percentage of subjects|||Number
715244|NCT00251693|Secondary|Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 4 as Assessed by Endoscopy - Crude Rate Analyses.|Percentage of subjects with complete healing of EE as assessed by endoscopy was analyzed for change in LA Esophagitis Classification grades A, B, C, or D to healed. Healed is defined as anything that is less than the criterion for Grade A. If it doesn’t meet the A criterion, it’s counted as healed.|4 Weeks|Crude rate analyses were performed on the ITT subjects who had at least 1 post-baseline endoscopy assessment performed within 7 days of the last day of study drug.||Percentage of subjects|||Number
715245|NCT00251693|Primary|Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Life Table Method.|Percentage of subjects with complete healing of EE as assessed by endoscopy was analyzed for change in LA Esophagitis Classification grades A, B, C, or D to healed. Healed is defined as anything that is less than the criterion for Grade A. If it doesn’t meet the A criterion, it’s counted as healed.|8 weeks|In addition to the ITT subjects who had at least 1 post-baseline endoscopy, Life Table Method included the ITT subjects without any post-baseline endoscopy within 7 days of the last day of study drug as censored.||Percentage of subjects|||Number
715246|NCT00251693|Secondary|Percentage of Subjects With Baseline Erosive Esophagitis Grade C or D Combined Who Have Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Life Table Method.|Percentage of subjects with baseline EE grade C or D combined who have complete healing of EE as assessed by endoscopy for Change in LA Esophagitis Classification Grades C and D to healed. Healed is defined as anything that is less than the criterion for Grade A. If it doesn’t meet the A criterion, it’s counted as healed.|8 Weeks|In addition to the ITT subjects who had at least 1 post-baseline endoscopy, Life Table Method included the ITT subjects without any post-baseline endoscopy within 7 days of the last day of study drug as censored.||percentage of subjects|||Number
715247|NCT00251693|Secondary|Percentage of Subjects With Baseline Erosive Esophagitis Grade C or D Combined Who Have Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Crude Rate Analysis.|Percentage of subjects with baseline EE grade C or D combined who have complete healing of erosive esophagitis as assessed by endoscopy for Change in LA Esophagitis Classification Grades C and D to healed. Healed is defined as anything that is less than the criterion for Grade A. If it doesn’t meet the A criterion, it’s counted as healed.|8 Weeks|Crude rate analyses were performed on the ITT subjects who had at least 1 post-baseline endoscopy assessment performed within 7 days of the last day of study drug.||percentage of subjects|||Number
715248|NCT00251693|Primary|Percentage of Subjects With Complete Healing of Erosive Esophagitis (EE) by Week 8 as Assessed by Endoscopy - Crude Rate Analysis.|Percentage of subjects with complete healing of EE as assessed by endoscopy was analyzed for change in LA Esophagitis Classification grades A, B, C, or D to healed. Healed is defined as anything that is less than the criterion for Grade A (greater than or equal to 1 mucosal break and less than 5 mm). If it doesn't meet the A criterion, it's counted as healed.|8 Weeks|Crude rate analyses were performed on the ITT subjects who had at least 1 post-baseline endoscopy assessment performed within 7 days of the last day of study drug.||Percentage of subjects|||Number
715249|NCT00251719|Secondary|Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 4 as Assessed by Endoscopy - Life Table Method|Percentage of subjects with complete healing of EE as assessed by endoscopy. Change in LA Esophagitis Classification grades A, B, C, D to healed was measured. Healed is defined as anything that is less than the criterion for Grade A. If it doesn’t meet the A criterion, it’s counted as healed.|4 Weeks|In addition to the ITT subjects who had at least 1 post-baseline endoscopy, Life Table Method included the ITT subjects without any post-baseline endoscopy within 7 days of the last day of study drug as censored.||percentage of subjects|||Number
715527|NCT00255190|Primary|Mean Change From Baseline to Month 12 for Platelet Count Values||Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.||Platelet Count x10 to the 3/mcL||Standard Deviation|Mean
715250|NCT00251719|Secondary|Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 4 as Assessed by Endoscopy - Crude Rate Analysis.|Percentage of subjects with complete healing of EE as assessed by endoscopy. Change in LA Esophagitis Classification grades A, B, C, D to healed was measured. Healed is defined as anything that is less than the criterion for Grade A. If it doesn’t meet the A criterion, it’s counted as healed.|4 Weeks|Crude rate analyses were performed on the ITT subjects who had at least 1 post-baseline endoscopy assessment performed within 7 days of the last day of study drug.||percentage of subjects|||Number
715251|NCT00251719|Primary|Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Life Table Method|Percentage of subjects with complete healing of EE as assessed by endoscopy. Change in LA Esophagitis Classification grades A, B, C, D to healed was measured. Healed is defined as anything that is less than the criterion for Grade A. If it doesn’t meet the A criterion, it’s counted as healed.|8 Weeks|In addition to the ITT subjects who had at least 1 post-baseline endoscopy, Life Table Method included the ITT subjects without any post-baseline endoscopy within 7 days of the last day of study drug as censored.||percentage of subjects|||Number
715252|NCT00251719|Secondary|Percentage of Subjects With Baseline Erosive Esophagitis Grade C or D Combined Who Have Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Life Table Method.|Percentage of subjects with baseline EE grade C or D combined who have complete healing of EE as assessed by endoscopy. Change in LA Esophagitis Classification grades C or D to healed was measured. Healed is defined as anything that is less than the criterion for Grade A. If it doesn’t meet the A criterion, it’s counted as healed.|8 Weeks|In addition to the ITT subjects who had at least 1 post-baseline endoscopy, Life Table Method included the ITT subjects without any post-baseline endoscopy within 7 days of the last day of study drug as censored.||percentage of subjects|||Number
715253|NCT00251719|Secondary|Percentage of Subjects With Baseline Erosive Esophagitis Grade C or D Combined Who Have Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Crude Rate Analysis.|Percentage of subjects with baseline EE grade C or D combined who have complete healing of EE as assessed by endoscopy. Change in LA Classification grades C or D to healed was measured. Healed is defined as anything that is less than the criterion for Grade A. If it doesn’t meet the A criterion, it’s counted as healed.|Week 8|Crude rate analyses were performed on the ITT subjects who had at least 1 post-baseline endoscopy assessment performed within 7 days of the last day of study drug.||percentage of subjects|||Number
715254|NCT00251719|Primary|Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Crude Rate Analysis.|Percentage of subjects with complete healing of EE as assessed by endoscopy. Change in LA Esophagitis Classification grades A, B, C, D to healed was measured. Healed is defined as anything that is less than the criterion for Grade A (greater than or equal to 1 mucosal break and less than 5 mm). If it doesn't meet the A criterion, it's counted as healed.|8 Weeks|Crude rate analysis were performed on the ITT subjects who had at least 1 post-baseline endoscopy assessment that was performed within 7 days of the last day of study drug.||percentage of subjects|||Number
715255|NCT00251745|Secondary|Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean|The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.|4 weeks|Analysis was conducted on an ITT population (all randomized subjects who received at least 1 dose of study drug and completed at least 1 diary entry for heartburn during treatment), but excluded subjects without any morning diary entries on Day 1 or later.||percentage of days||Standard Deviation|Mean
715256|NCT00251745|Secondary|Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median|The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.|4 weeks|Analysis was conducted on an ITT population (all randomized subjects who received at least 1 dose of study drug and completed at least 1 diary entry for heartburn during treatment), but excluded subjects without any morning diary entries on Day 1 or later.||percentage of days||Inter-Quartile Range|Median
715257|NCT00251745|Primary|Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean|The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked.|4 weeks|Analysis was conducted on an intent-to-treat (ITT) population that included all randomized subjects who received at least 1 dose of study drug and completed at least 1 diary entry for heartburn during treatment. All ITT populations excluded subjects with confirmed Barrett's esophagus and/or definite dysplastic changes.||percentage of days||Standard Deviation|Mean
715258|NCT00251745|Primary|Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median|The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked.|4 weeks|Analysis was conducted on an intent-to-treat (ITT) population that included all randomized subjects who received at least 1 dose of study drug and completed at least 1 diary entry for heartburn during treatment. All ITT populations excluded subjects with confirmed Barrett's esophagus and/or definite dysplastic changes.||percentage of days||Inter-Quartile Range|Median
715259|NCT00251758|Secondary|Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean|The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.|4 weeks|Analysis was conducted on an ITT population (all randomized subjects who received at least 1 dose of study drug and completed at least 1 diary entry for heartburn during treatment), but excluded subjects without any morning diary entries on Day 1 or later.||percentage of days||Standard Deviation|Mean
715260|NCT00251758|Secondary|Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median|The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.|4 weeks|Analysis was conducted on an ITT population (all randomized subjects who received at least 1 dose of study drug and completed at least 1 diary entry for heartburn during treatment), but excluded subjects without any morning diary entries on Day 1 or later.||percentage of days||Inter-Quartile Range|Median
716047|NCT00266032|Secondary|Number of Bleeding / Spotting Episodes in 90 Day Reference Period|The mean number of bleeding / spotting episodes was analyzed using reference periods of 90 days as recommended by the WHO.|Up to one year|FAS (reflecting ITT), all treated subjects, no imputation||Episodes||Standard Deviation|Mean
715261|NCT00251758|Primary|Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean|The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked.|4 weeks|Analysis was conducted on an intent-to-treat (ITT) population that included all randomized subjects who received at least 1 dose of study drug and completed at least 1 diary entry for heartburn during treatment. All ITT populations excluded subjects with confirmed Barrett's esophagus and/or definite dysplastic changes.||percentage of days||Standard Deviation|Mean
715262|NCT00251758|Primary|Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median|The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked.|4 weeks|Analysis was conducted on an intent-to-treat (ITT) population that included all randomized subjects who received at least 1 dose of study drug and completed at least 1 diary entry for heartburn during treatment. All ITT populations excluded subjects with confirmed Barrett's esophagus and/or definite dysplastic changes.||percentage of days||Inter-Quartile Range|Median
715263|NCT00251862|Secondary|Screening Intentions|Screening intentions were also assessed as part of the posttest. Subjects were asked how sure they were that they would schedule an appointment to get screened for colorectal cancer and how sure they were that they would complete the screening test they scheduled. An ordered 5-point response frame was used ranging from 1 for “not at all sure” to 5 for “completely sure”.|Immediate post-intervention study visit|||units on a scale||Standard Deviation|Mean
715264|NCT00251862|Secondary|Patient Satisfaction With Decision Making Process|Patient satisfaction with the decision-making process (SDMP) was assessed using the validated 12-item Satisfaction with the Decision-Making Process scale. Five ordered response categories were used for each item. Each response was assigned a point score ranging from 1 for “strongly disagree” (or “poor”) to 5 for “strongly agree” (or “excellent”). A cumulative score was calculated based on the summed response scores for each item (maximum score = 60). Mean item substitution was used to impute missing data.|Immediate post-intervention primary care provider (PCP) visit|||units on a scale||Standard Deviation|Mean
715265|NCT00251862|Secondary|Patient Knowledge|Knowledge was assessed at baseline (pretest) and at the time of the exit survey (posttest) based on responses to a 12-item questionnaire (True/False/Don’t know) that inquired about CRC risk factors, the rationale and goals of screening, and age at which screening should begin. Cumulative knowledge scores (range, 0-12) were derived by summing correct responses to the 12 individual knowledge questions.|Immediate post-intervention study visit|||units on a scale||Standard Deviation|Mean
715266|NCT00251862|Primary|Patient Adherence (Test Completion)|Completion of a screening test within 12 months of the study visit.|12 months post-intervention|Intention to treat||participants|||Number
715267|NCT00251927|Secondary|Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With Severe Heartburn|Presence of heartburn assessed retrospectively by the investigator. Classified by severity (none, mild, moderate, severe). Participants with severe heartburn|At 5 year visit|||participants|||Number
715268|NCT00251927|Secondary|Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With Moderate Heartburn|Presence of heartburn assessed retrospectively by the investigator. Classified by severity (none, mild, moderate, severe). Participants with moderate heartburn|At 5 year visit|||participants|||Number
715269|NCT00251927|Secondary|Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With Mild Heartburn|Presence of heartburn assessed retrospectively by the investigator. Classified by severity (none, mild, moderate, severe). Participants with mild heartburn|At 5 year visit|||participants|||Number
715270|NCT00251927|Secondary|Los Angeles (LA) Grade C at 5 Year Visit|"Endoscopic findings classified according to the Los Angeles classification:
Grade Normal - endoscopy reveals no mucosal break Grade A- one or more mucosal breaks <5 mm in maximal length Grade B - one or more mucosal breaks >5 mm, but without continuity across mucosal folds Grade C - Mucosal breaks continuous between >2 mucosal folds, but involving less than 75% of the esophageal circumference Grade D - Mucosal breaks involving more than 75% of the esophageal circumference"|At 5 year visit|||participants|||Number
715271|NCT00251927|Secondary|Los Angeles (LA) Grade 'B' at 5 Year Visit|"Endoscopic findings classified according to the Los Angeles classification:
Grade Normal - endoscopy reveals no mucosal break Grade A- one or more mucosal breaks <5 mm in maximal length Grade B - one or more mucosal breaks >5 mm, but without continuity across mucosal folds Grade C - Mucosal breaks continuous between >2 mucosal folds, but involving less than 75% of the esophageal circumference Grade D - Mucosal breaks involving more than 75% of the esophageal circumference"|At 5 year visit|||participants|||Number
715272|NCT00251927|Secondary|Los Angeles (LA) Grade 'A' at 5 Year Visit|"Endoscopic findings classified according to the Los Angeles classification:
Grade Normal - endoscopy reveals no mucosal break Grade A- one or more mucosal breaks <5 mm in maximal length Grade B - one or more mucosal breaks >5 mm, but without continuity across mucosal folds Grade C - Mucosal breaks continuous between >2 mucosal folds, but involving less than 75% of the esophageal circumference Grade D - Mucosal breaks involving more than 75% of the esophageal circumference"|At 5 year visit|||participants|||Number
715273|NCT00251927|Secondary|Percentage Time With pH<4 During 24-hour pH Metry at 5 Year Visit|Intra-gastric acid exposures assessed by 24-h pH-metry. Only participants with pH-emtry performed at 5 year visit included|At 5 year visit|||percentage of time recorded||Standard Deviation|Mean
715274|NCT00251927|Secondary|Total Score for Microscopic Reflux-related Changes in the Distal Esophagus 2 cm Above the Z-line, at 5 Year Visit|The total score expressed as a mean of all the scores/number of lesions assessed; scored 2 when erosion/necrosis is found. The score could range from 0 to 2 (maximum severity). Only participants with biopsy at 5 years visit included|At 5 year visit|||units on a scale||Standard Error|Mean
715275|NCT00251927|Secondary|Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With no Heartburn|Presence of heartburn assessed retrospectively by the investigator. Classified by severity (none, mild, moderate, severe) Participants with no heartburn|At 5 year visit|||participants|||Number
715366|NCT00252174|Primary|Spielberger State-Trait Anxiety Inventory (STAI)|Established self-report measure of anxiety containing a State and Trait subscale and scored on a four-point Likert scale. Scores for each subscale range from 10 to 40 and combined from 20 to 80 with higher scores indicative of greater anxiety.|Obtained over the 3 months of active participation|Data has been damaged/lost in a flood that destroyed the office that contained much of the primary source material|||||
715276|NCT00251927|Secondary|Los Angeles (LA) Grade 'Normal' at 5 Year Visit|"Endoscopic findings classified according to the Los Angeles classification:
Grade Normal - endoscopy reveals no mucosal break Grade A- one or more mucosal breaks <5 mm in maximal length Grade B - one or more mucosal breaks >5 mm, but without continuity across mucosal folds Grade C - Mucosal breaks continuous between >2 mucosal folds, but involving less than 75% of the esophageal circumference Grade D - Mucosal breaks involving more than 75% of the esophageal circumference"|At 5 year visit|||participants|||Number
715277|NCT00251927|Primary|Number of Participants With Treatment Failure at 5 Years|Treatment failure in the surgical arm defined when need for medical treatment for control of symptoms from reflux disease. Treatment failure in the medical arm defined when need for treatment other than esomeprazole for control of symptoms of reflux disease.|During 5 years|||participants|||Number
715278|NCT00244712|Secondary|Number of Participants Who Reported a Suspected Abacavir Hypersensitivity Reaction (ABC HSR) Reaction or Proximal Renal Tubule Dysfunction|The number of participants that experienced symptoms of a suspected abacavir hypersensitivity reaction was tabulated. The number of participants that developed laboratory signs of proximal renal tubule dysfunction was tabulated.|Baseline through 96 weeks|The Safety population which included all randomized participants who received at least one dose of study medication.||participants|||Number
715279|NCT00244712|Secondary|Number of Confirmed Virologic Failure Participants at Week 96 With Genotypic Resistance to Lamivudine (3TC) and Emtricitabine (FTC) and Had Phenotypic Reduced Susceptibility|A blood sample was drawn for participants failing to respond to therapy and the mutations present in the virus were identified. New mutations that developed to the NRTI class at the time of failure that no longer responded to lamivudine or emtricitabine were tabulated by drug class.|Baseline and time of virologic failure (up to Week 96)|Participants in the Intent-To-Treat-Exposed (ITT-E) population who met the confirmed virologic failure criteria and had the M184 mutations.||participants|||Number
715280|NCT00244712|Secondary|Number of Confirmed Virologic Failure Participants Who Had Treatment-emergent Genotypic Resistance Through 96 Weeks|A blood sample was drawn for participants failing to respond to therapy and the mutations present in the virus were identified. For each participant, the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New mutations that developed at the time of failure was tabulated by drug class. NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor.|Baseline and time of virologic failure (up to Week 96)|Participants in the Intent-To-Treat-Exposed (ITT-E) population who met the confirmed virologic failure criteria with paired baseline and virologic failure genotypic evaluations||participants|||Number
715281|NCT00244712|Secondary|Number of Participants Who Meet the Protocol-defined Virologic Failure (PDVF) Criteria at Week 96|The number of participants that failed to respond to therapy based on the protocol definition of virologic failure (PDVF) was tabulated. PDVF was defined as either no confirmed HIV-1 RNA <200 copies/mL or HIV-1 RNA rebound >= 200 copies/mL on two consecutive occasions.|Baseline to Week 96|The Intent-To-Treat-Exposed (ITT-E) population||participants|||Number
715282|NCT00244712|Secondary|Median Change From Baseline in CD4+ Cells at Weeks 48 and 96|A blood sample was drawn to determine the CD4+ cell count at Weeks 48 and 96. Change from baseline was defined as CD4+ cell count at week 96 minus CD4+ cell count at baseline.|Weeks 48 and 96|The Intent-To-Treat-Exposed (ITT-E) population, observed analysis.||cells per cmm||Full Range|Median
715283|NCT00244712|Secondary|Median Change From Baseline in HIV-1 RNA at Week 48 and 96|A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Weeks 48 and 96. Change from baseline was defined as HIV-1 RNA level at Weeks 48 and 96 minus HIV-1 RNA level at baseline.|Weeks 48 and 96|The Intent-To-Treat-Exposed (ITT-E) population, observed analysis.||log10 copies/mL||Full Range|Median
715284|NCT00244712|Secondary|Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL|A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Weeks 48 and 96. The percentage of participants with HIV-1 RNA <400 copies/mL at Weeks 48 and 96 were tabulated by treatment arm in participants with baseline HIV-1 RNA >=100,000 copies/mL.|Weeks 48 and 96|The Intent-To-Treat-Exposed (ITT-E) population. The secondary analysis methods were missing=failure (M=F), switch included, TLOVR, Observed, and M/D=F||percentage of participants|||Number
715285|NCT00244712|Secondary|Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL|A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Weeks 48 and 96. The percentage of participants with HIV-1 RNA <400 copies/mL at Weeks 48 and 96 were tabulated by treatment arm in participants with baseline HIV-1 RNA <100,000 copies/mL.|Weeks 48 and 96|The Intent-To-Treat-Exposed (ITT-E) population. The secondary analysis methods were missing=failure (M=F), switch included, TLOVR, Observed, and M/D=F||percentage of participants|||Number
715286|NCT00244712|Secondary|Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96|A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 48 and 96. The percentage of participants with HIV-1 RNA <400 copies/mL at Weeks 48 and 96 were tabulated by treatment arm with stratification by baseline HIV-1 RNA levels (<100,000 copies/mL and >=100,000 copies/mL).|Weeks 48 and 96|The Intent-To-Treat-Exposed (ITT-E) population. The secondary analysis methods were missing=failure (M=F), switch included, TLOVR, Observed, and M/D=F||percentage of participants|||Number
715287|NCT00244712|Secondary|Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL|A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 48 and 96. The percentage of participants with HIV-1 RNA <50 copies/mL at Weeks 48 and 96 were tabulated by treatment arm in participants with baseline HIV-1 RNA >=100,000 copies/mL.|Weeks 48 and 96|The Intent-To-Treat-Exposed (ITT-E) population. The secondary analysis methods were M=F, switch included, TLOVR, Observed, and M/D=F||percentage of participants|||Number
715288|NCT00244712|Secondary|Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL|A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Weeks 48 and 96. The percentage of participants with HIV-1 RNA <50 copies/mL at Weeks 48 and 96 were tabulated by treatment arm in participants with baseline HIV-1 RNA <100,000 copies/mL.|Weeks 48 and 96|The Intent-To-Treat-Exposed (ITT-E) population. The secondary analysis methods were missing=failure (M=F), switch included, TLOVR, Observed, and M/D=F||percentage of participants|||Number
715289|NCT00244712|Secondary|Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96|A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 96. The percentage of participants with HIV-1 RNA <50 copies/mL at Week 96 were tabulated by treatment arm with stratification by baseline HIV-1 RNA levels (<100,000 copies/mL and >=100,000 copies/mL).|Week 96|The Intent-To-Treat-Exposed (ITT-E) population. The secondary analysis methods were M=F, switch included, TLOVR, Observed, and M/D=F.||percentage of participants|||Number
715290|NCT00244712|Secondary|Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48|A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 48. The percentage of participants with HIV-1 RNA <50 copies/mL at Week 48 were tabulated by treatment arm with stratification by baseline HIV-1 RNA levels (<100,000 copies/mL and >=100,000 copies/mL).|Week 48|The Intent-To-Treat-Exposed (ITT-E) population which included all patients that had received at least one dose of study medication. The secondary analysis methods were time to loss of virologic response (TLOVR), Observed (Obs), and missing/discontinuation=failure (M/D=F) analyses.||percentage of participants|||Number
715291|NCT00244712|Primary|Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48 by Missing=Failure (M=F), Switched Included Analysis.|A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 48. The percentage of participants with HIV-1 RNA <50 copies/mL were tabulated by treatment arm with stratification by baseline HIV-1 RNA (<100,000 copies/mL and >=100,000 copies/mL).|Week 48|The Intent-To-Treat-Exposed (ITT-E) population which included all randomized participants that had received at least one dose of study medication. In the missing=failure, switched included analysis, participants who had switched their randomized treatment for other treatment were considered as failures, i.e., HIV-1 RNA >=50 copies/mL.||percentage of participants|||Number
715292|NCT00244725|Secondary|Percentage of Participants With Elevated Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Direct Bilirubin (DB) and Total Bilirubin (TB) by 2 Fold and 3 Fold From Upper Normal Limits (ULN) Any Time On-treatment|The ranges (low concern value; high concern value) for AST (none; > 3 fold upper normal limit (ULN) ), ALT (none; >3 fold ULN), total bilirubin (none; >= 34.2 micromole per litre [umol/L]), Direct bilirubin (none; >= 34.2 umol/L). Percentage of participants with elevated values by 2 fold and 3 fold from ULN any time on-treatment were reported.|Up to 12 days|ITT population. Number of participants were available at the time of analysis were included.||Percentage of participants||95% Confidence Interval|Number
715293|NCT00244725|Secondary|Percentage of Participants With Total VTE Any Time After Start of Treatment|Participants were assessed for VTE at all study visits and at the end of the study (Day 10±2) or at early withdrawal. Any participant who remained asymptomatic for VTE at the end of the study were received a mandatory bilateral venogram. Participants who were withdrawn early and had been objectively confirmed to have a VTE event by a method other than venography were not required to undergo venography. A participant was included in the ICAC-adjudicated incidence of total VTE if experienced any of adjudicated asymptomatic DVT at early withdrawal or after 8-12 days of study treatment and no later than 1 day after end of study treatment, adjudicated symptomatic DVT or PE at any time during study treatment or death adjudicated to be related to VTE during study treatment. Percentage of participants with total VTE any time after start of treatment were reported.|Up to Visit 9 (Day 28 post treatment)|ITT population. The participants from ITT population who were with objectively confirmed symptomatic VTE, venographically detected VTE at early withdrawal or an evaluable venogram at completion of study treatment were used for the analysis||Percenatge of participants||95% Confidence Interval|Number
715294|NCT00244725|Secondary|Percentage of Participants With VTE and/or Major Bleeding Over 10±2 Days of Treatment|A participant was included in the ICAC-adjudicated incidence of major bleeding if experienced an adjudicated major bleed up to 12 days after the start of study treatment and no later than 1 day after end of study treatment. Percentage of participants with VTE and/or major bleeding over 10±2 days of treatment were reported.|Up to 12 days|ITT population. The participants from ITT population who were efficacy evaluable or reported a major bleed or VTE by the time of early withdrawal were used for the analysis||Percentage of participants||95% Confidence Interval|Number
715295|NCT00244725|Secondary|Percentage of Participants With Major Bleeds Over 10 ± 2 Days of Treatment|A participant was included in the ICAC-adjudicated incidence of major bleeding if participant experienced an adjudicated major bleed up to 12 days after the start of study treatment and no later than 1 day after end of study treatment. Major bleed was defined as clinically overt bleeding, 1) Clinical overt bleeding: clinically apparent bleeding or signs and/or symptoms suggestive of bleeding with confirmatory imaging studies (e.g., ultrasound, computed tomography) 2. Critical Site Involvement: Intracranial, retroperitoneal, intra-ocular, intraspinal, pericardial. 3. Decrease in Hgb > 2 g/dL from baseline, 4. Transfusion of > 2 units of packed RBCs, 5. Medical or Surgical Intervention for the Reported Bleed, 6. Fatal Bleed. If the event satisfied one of the above criteria.|Up to 12 days|ITT Population. The participants from ITT population who completed study treatment (Day-10 visit) or reported a major bleed by the time of early withdrawal were used for the analysis||Percentage of participants||95% Confidence Interval|Number
715296|NCT00244725|Secondary|Concentration of Trough Anti-IIa Activity Over the Duration of Treatment and Follow-up|In all participants, additional 3 milliliter of blood was collected at the time of other blood sampling as follow: Baseline, Day 3 (predose, 2, 4, 8, 10, and 12 hours post dose), Day 5 (predose), and Day 10 (predose) or early withdrawal from study medication for the assessment of anti-factor IIa activity. Samples were collected in 3.8% sodium citrate tubes and immediately chilled in ice. Plasma were centrifuged and frozen at approximately -20ºC until time of shipment to the regional central laboratory. Concentration of Trough Anti-IIa Activity over the duration of treatment and follow-up were reported.|Up to 68 days|ITT population.||Microgram per millilitre (mcg/ml)||Standard Deviation|Geometric Mean
715323|NCT00244985|Secondary|Overall Response Rate (Complete and Partial Responses) at 20 Weeks|Complete Response (CR): During observation no disease is apparent, including measurable and non-measurable disease, for at least 28 days, as confirmed by a second assessment following the original observation of no disease. All nodes visualized on imaging studies or palpable on exams must have regressed to normal size their greatest transverse diameter for nodes > 1.5 before therapy. Partial Response (PR): A 50% or greater decrease from baseline in the sum of the products of the longest perpendicular diameters of all the measured lesions is noted for at least 28 days as confirmed by a second assessment following the observation of the > or = to 50% decrease. Additionally, no appearance of new lesions is noted.|20 weeks|All treated and eligible patients||percentage of participants||95% Confidence Interval|Number
715297|NCT00244725|Secondary|Percentage of Total Symptomatic VTE Over 10 ± 2 Days of Treatment|A participant who reported symptoms of DVT was considered to had an adjudicated objectively confirmed symptomatic DVT if the ICAC answer to the question ‘Was a symptomatic DVT identified?’ was ‘Yes’ and the event happened no more than 12 days after start of study treatment (unless exemption for extended treatment was granted by the medical monitor) and no more than 1 day after end of study treatment. The participant was considered to had a proximal DVT if either of the investigator’s answers to the questions ‘Left distal’ and ‘Right distal’ was ‘DVT’. The participant was considered to had a distal DVT if either of the investigator’s answers to the questions ‘Left distal’ and ‘Right distal’ was ‘DVT’. Percentage of participants with total symptomatic (distal and proximal) VTE over 10 ± 2 days of treatment were reported.|Up to 12 days|ITT population. The participants from ITT population who were with objectively confirmed symptomatic VTE, venographically detected VTE at early withdrawal or an evaluable venogram at completion of study treatment were used for the analysis.||Perentage of participants||95% Confidence Interval|Number
715298|NCT00244725|Secondary|Percentage of Participants With Total Asymptomatic VTE Over 10 ± 2 Days of Treatment|A participant was included in the Independent Central Adjudication Committee (ICAC)-adjudicated incidence of total VTE if experienced any of adjudicated asymptomatic deep vein thrombosis (DVT) at early withdrawal or after 8-12 days of study treatment and no later than 1 day after end of study treatment, adjudicated symptomatic DVT or PE at any time during study treatment or death adjudicated to be related to VTE during study treatment. A participant was considered to have had an asymptomatic evaluable venogram if the ICAC answer to the DVT question was ‘Yes’ or ‘No’, and to have had an adjudicated asymptomatic DVT if the answer was ‘Yes’. The participant was considered to had a proximal DVT if either of the investigator’s answers to the questions ‘Left distal’ and ‘Right distal’ is ‘DVT’. The participant was considered to had a distal DVT if either of the investigator’s answers to the questions ‘Left distal’ and ‘Right distal’ is ‘DVT’.|Up to 12 days|ITT population. The participants from ITT population who were with objectively confirmed symptomatic VTE, venographically detected VTE at early withdrawal or an evaluable venogram at completion of study treatment were used for the analysis.||Percentage of participants||95% Confidence Interval|Number
715299|NCT00244725|Secondary|Number of Death Due to VTE Over 10 ± 2 Days of Treatment|A participant was considered dead from an adjudicated VTE-related cause if the death classification was recorded as ‘Fatal PE’. A participant was considered to have died from an investigator-assessed VTE-related cause if the investigator’s death classification was recorded as ‘Fatal PE’. Number of death due to VTE over 10 ± 2 days of treatment were reported.|Up to 12 days|ITT population. The participants from ITT population who were with objectively confirmed symptomatic VTE, venographically detected VTE at early withdrawal or an evaluable venogram at completion of study treatment were used for the analysis.||Participants|||Number
715300|NCT00244725|Secondary|Percentage of Participants With PE Over 10 ± 2 Days of Treatment|Participant who reported symptoms of PE were considered to have had an adjudicated objectively confirmed symptomatic PE if the ICAC answer to the question ‘Was a PE identified?’ was ‘Yes’. E was characterized as fatal PE non-fatal PE and total PE events. Data has been presented for fatal PE non-fatal PE and total PE events over 12 days.|Up to 12 days|ITT population. The participants from ITT population who were with objectively confirmed symptomatic VTE, venographically detected VTE at early withdrawal or an evaluable venogram at completion of study treatment were used for the analysis.||Percentage of participants||95% Confidence Interval|Number
715301|NCT00244725|Secondary|Percentage of Participants With Distal DVT Over 10 ± 2 Days of Treatment|A participant was considered to have had an asymptomatic evaluable venogram if the ICAC answer to the DVT question was ‘Yes’ or ‘No’, and to have had an adjudicated asymptomatic DVT if the answer was ‘Yes’. A participant who reported symptoms of DVT was considered to had an adjudicated objectively confirmed symptomatic DVT if the ICAC answer to the question ‘Was a symptomatic DVT identified?’ was ‘Yes’ and the event happened no more than 12 days after start of study treatment (unless exemption for extended treatment was granted by the medical monitor) and no more than 1 day after end of study treatment. In both asymptomatic and symptomatic DVT, the participant was considered to had a distal DVT if either of the investigator’s answers to the questions ‘Left distal’ and ‘Right distal’ is ‘DVT’.|Up to 12 days|ITT population. The participants from ITT population who were with objectively confirmed symptomatic VTE, venographically detected VTE at early withdrawal or an evaluable venogram at completion of study treatment were used for the analysis.||Percentage of paticipants||95% Confidence Interval|Number
715302|NCT00244725|Secondary|Percentage of Participants With Proximal DVT Over 10 ± 2 Days of Treatment|Proximal DVT is defined as DVT in or above the popliteal vein. A participant was considered to have had an asymptomatic evaluable venogram if the ICAC answer to the DVT question was ‘Yes’ or ‘No’, and to have had an adjudicated asymptomatic DVT if the answer was ‘Yes’. A participant who reported symptoms of DVT was considered to had an adjudicated objectively confirmed symptomatic DVT if the ICAC answer to the question ‘Was a symptomatic DVT identified?’ was ‘Yes’ and the event happened no more than 12 days after start of study treatment (unless exemption for extended treatment was granted by the medical monitor) and no more than 1 day after end of study treatment. In both asymptomatic and symptomatic DVT, the participant was considered to had a proximal DVT if either of the ICAC answers to the questions ‘Left proximal’ and ‘Right proximal’ was ‘DVT’. Percentage of participants with proximal DVT over 10 ± 2 days of treatment were reported.|Up to 12 days|ITT population. The participants from ITT population who were with objectively confirmed symptomatic VTE, venographically detected VTE at early withdrawal or an evaluable venogram at completion of study treatment were used for the analysis.||Percentage of participants||95% Confidence Interval|Number
715324|NCT00244985|Secondary|Partial Response Rate at 20 Weeks|Partial Response (PR): A 50% or greater decrease from baseline in the sum of the products of the longest perpendicular diameters of all the measured lesions is noted for at least 28 days as confirmed by a second assessment following the observation of the > or = to 50% decrease. Additionally, no appearance of new lesions is noted.|20 weeks|All treated and eligible patients||percentage of participants||95% Confidence Interval|Number
715367|NCT00252187|Secondary|Change in Left Ventricular Ejection Fraction at 8 Weeks|Left Ventricle Ejection Fraction (LVEF)is a clinical parameter used by cardiologists to describe how well the heart is pumping. LVEF is a measure of the amount of blood pumped out of the lower chamber (ventricle) of the heart during a heartbeat, measured by Magnetic Resonance Imaging (MRI).|Baseline and 8 weeks|Per protocol population||percentage||Standard Deviation|Mean
715303|NCT00244725|Primary|Percentage of Participants With Total VTE Event Over 10 ± 2 Days of Treatment|Participants were assessed for VTE at all study visits and at the end of study (Day 10±2) or at early withdrawal. Any participant who remained asymptomatic for VTE at the end of the study did not receive a mandatory bilateral venogram following at least 8 days on study medication. Participants who were withdrawn early and had been objectively confirmed to have a VTE event by a method other than venography were not required to undergo venography. A participant was included in the Independent Central Adjudication Committee (ICAC)-adjudicated incidence of total VTE if he/ she experienced any of adjudicated asymptomatic deep vein thrombosis (DVT) at early withdrawal or after 8-12 days of study treatment and no later than 1 day after end of study treatment, adjudicated symptomatic DVT or pulmonary embolism (PE) at any time during study treatment or death adjudicated to be related to VTE during study treatment.|Up to Visit 7 (10 ± 2 days of treatment)|ITT population comprised of all participants who were randomized and received at least one dose of study treatment. Total number of participants with objectively confirmed symptomatic VTE, venographically detected VTE at early withdrawal or an evaluable venogram at study completion were used for analysis.||Percentage of participants||95% Confidence Interval|Number
715304|NCT00244764|Secondary|Progression-free Survival|Progression-free Survival is defined as the interval between the first day of treatment and the earliest date of disease progression or death due to any cause, whichever occurred first. Progressive disease is defined as a >=20% increase in target lesions.|From the first day of treatment to the earliest date of disease progression or death due to any cause (up to 2.40 years)|All Enrolled Population. Participants who did not progress or die were censored at their last radiologic assessment.||weeks||95% Confidence Interval|Median
715305|NCT00244764|Secondary|Duration of Response|Using RECIST criteria: date of first confirmed tumor response (CR or PR) to date of tumor progression or to death. Participants who did not progress or die were censored at their last radiologic assessment. Only participants who had a response were analyzed.|First response until progression of disease (up to 2.40 years). Assessments occurred at Week 12 and every 8 weeks thereafter.|All participants in the Enrolled Population who had a CR or PR||weeks||95% Confidence Interval|Median
715306|NCT00244764|Primary|Stable Disease at 12 Weeks - Interim Analysis of First 60 Participants|The protocol called for an interim analysis of the first 60 participants to determine their status at Week 12, and to determine the number of participants with stable disease, although all categories were reported. Stable disease is defined as a disease that has not grown enough to be called progressive disease and has not shrunk enough to be called partial/complete response.|Week 12|Subset of the All Enrolled Population including only the first 60 participants||participants|||Number
715307|NCT00244764|Primary|Overall Response by RECIST Criteria|The overall response is the number of participants who experience a confirmed complete (CR) or partial response (PR) of the total analysis population. Per the Response Evaluation Criteria In Solid Tumors (RECIST): CR = all detectable tumor has disappeared, PR = a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum, Progressive disease (PD) = a >=20% increase in target lesions, Stable Disease = small changes that do not meet previously given criteria.|Baseline to Response (up to 2.40 years). Assessments occurred at Week 12 and every 8 weeks thereafter.|All Enrolled: all participants who received at least one dose of pazopanib||participants|||Number
715308|NCT00244855|Secondary|Survival|Percentage of patients remaining alive estimated according to the Kaplan-Meier method|At 6 months, 12 months and 24 months after enrollment|||Kaplan-Meier estimated % of patients||95% Confidence Interval|Number
715309|NCT00244855|Primary|Progression-free Survival|Survival without measurable progression of lymphoma estimated according to the Kaplan-Meier method|At 3 and 6 months after enrollment|||Kaplan-Meier estimated % of patients||95% Confidence Interval|Number
715310|NCT00244881|Secondary|Response/Stable Disease Rate Defined as the Percentage of Patients Demonstrating CR + PR + SD||12 weeks|||percentage of participants|||Number
715311|NCT00244881|Primary|Objective Response Rate (ORR = CR + PR) Classified According to RECIST Criteria|RECIST 1.0 Criteria|Up to 7 years|||percentage of participants||95% Confidence Interval|Number
715312|NCT00244881|Primary|Fraction of Patients With Increased Levels of Circulating Endothelial Cells|An exact 95% confidence interval (CI) will be calculated for the CEC response rate. With 26 patients, this CI will be no wider than 40% (e.g., if 13 of 26 patients respond, the CI is 30% to 70%).|After 3 weeks of treatment|||percentage of participants|||Number
715313|NCT00244933|Secondary|In Vivo Effects of Genistein in Breast Cancer Tissue Biomarkers (Ki67, TUNEL Assay, p-Akt, NF-kB, Immunohistochemistry and cDNA Microarray Analysis)||At baseline (pre-genistein treatment) and 7 days following genistein treatment||||||
715314|NCT00244933|Secondary|Correlate Responses With Plasma Genistein Levels||At course 1 day -7, course 1 day -1 (before and 4 hours after dose), course 2 day 1 (before and 4 hours after dose)||||||
715315|NCT00244933|Secondary|Qualitative and Quantitative Toxicities||30 days following treatment||||||
715316|NCT00244933|Secondary|Duration of Survival||At 1 year following study treatment||||||
715317|NCT00244933|Secondary|Time to Disease Progression||From the time that treatment is initiated until the time restaging indicates progressive disease.||||||
715318|NCT00244933|Secondary|Overall Survival||From the time the last patient comes off study treatment for one year to monitor survival||||||
715319|NCT00244933|Secondary|Duration of Response||From the time the last patient comes off study treatment for one year||||||
715320|NCT00244933|Primary|Objective Response Rate by RECIST Criteria Following|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|every 2 courses until disease progression or death, up to 24 weeks|||participants|||Number
715321|NCT00244985|Secondary|Overall Survival (OS) Rate at 2 Years|Overall survival was defined as time from date of treatment initiation until date of death due to any cause.|2 years|All treated and eligible patients||percentage of participants||95% Confidence Interval|Number
715322|NCT00244985|Secondary|Progression Free Survival (PFS) Rate at 2 Years|Progressive disease is defined as at least a 20% increase in the sum of the longest diameter of target lesions or the appearance of new lesions.|2 years|All treated and eligible patients||percentage of participants||95% Confidence Interval|Number
715325|NCT00244985|Primary|Complete Response Rate at 20 Weeks|Complete Response (CR): During observation no disease is apparent, including measurable and non-measurable disease, for at least 28 days, as confirmed by a second assessment following the original observation of no disease. All nodes visualized on imaging studies or palpable on exams must have regressed to normal size their greatest transverse diameter for nodes > 1.5 em before therapy). Previously involved nodes that were 1.1 to 1.5 in their greatest transverse diameter before treatment must have decreased to 1 cm in their greatest transverse diameter after treatment or by more than 75% in the sum of the products of the greatest diameters (SPD). The patient must also be free from symptoms related to lymphoma, if present before therapy with no worsening in performance status from baseline. Bone marrow, if initially positive at baseline, must be histologically negative for lymphoma and the liver and spleen, if enlarged due to lymphoma at baseline, should be normalized.|20 weeks|All treated and eligible patients||percentage of participants||95% Confidence Interval|Number
715326|NCT00245011|Secondary|Correlative Dose of Radiation by Low Dose and High Dose Samarium-153||completion of treatment||||||
715327|NCT00245011|Secondary|Long Term Side Effects of Infusional Samarium-153 After Study Treatment||Continual||||||
715328|NCT00245011|Secondary|Toxicity at End of Study Treatment||Continual and at End of Study||||||
715329|NCT00245011|Secondary|Overall and Progression-free Survival After Study Treatment||Continual||||||
715330|NCT00245011|Secondary|Predictive Value of Imaging Studies||At Time of Tumor Resection||||||
715331|NCT00245011|Primary|Tumor Response|WHO (World Health Organization) tumor measurement criteria used to determine response.|1 week after study treatment|11 subjects, heavily treated with chemotherapy with osteosarcoma metastatic to bone were enrolled; 10 evaluable for response. Mean age: 18 years. Age range was14-30 years.||participants|||Number
715339|NCT00245050|Secondary|Quality of Life (QOL) as Measured by Functional Assessment of Cancer Therapy (FACT-G)|QOL was measured with the FACT-G questionnaire following the third course of doxorubicin HCl liposome before the patient was seen by the treating physician and before chemotherapy was administered. The FACT-G, version 4, is a 27-item core questionnaire evaluating the domains of physical, functional, family-social, and emotional well-being (PWB, FWB, SWB, EWB). Total score ranges from 0-108 and higher scores indicate better QOL.|After Cycle 3 of chemotherapy (on average at 3 months)|||Total scores on FACT-G scale||Standard Deviation|Mean
715340|NCT00245050|Primary|Number of Participants With Palmar-plantar Erythrodysesthesia (PPE)|Patients were monitored weekly with phone calls from the research nurse and monthly at clinic visits for overall (including pyridoxine) and specific doxorubicin HCl liposome related toxicities using the National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTCAE), version 3.0.|Treatment repeats every 4 weeks for up to 6 courses in the absence of unacceptable toxicity.|Patients were evaluable for PPE/HFS(Hand-Foot Syndrome) incidence and toxicity assessment if they received at least one course of chemotherapy. Intention to treat analysis was used.||participants|||Number
715341|NCT00245063|Primary|Objective Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT, MRI or X-Ray: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Up to 4 weeks|||percentage of responding patients|||Number
715342|NCT00251979|Secondary|Number of Days Hospitalized Due to Rebleeding During the 30-day Treatment Period||Within 30 days|||days|||Number
715343|NCT00251979|Secondary|Number of Blood Units Transfused Within 30 Days||within 30 days|||blood units|||Number
715344|NCT00251979|Secondary|Number of Blood Units Transfused Within 72 Hours||Within 72 hours|||blood units|||Number
715345|NCT00251979|Secondary|Requirement for Endoscopic Re-treatment Within 30 Days||Within 30 days|||Participants|||Number
715346|NCT00251979|Secondary|Requirement for Endoscopic Re-treatment Within 72 Hours||Within 72 hours|||Participants|||Number
715347|NCT00251979|Secondary|Requirement for Surgery Within 30 Days||Within 30 days|||Participants|||Number
715348|NCT00251979|Secondary|Requirement for Surgery Within 72 Hours||Within 72 hours|||Participants|||Number
715349|NCT00251979|Secondary|Death Related to Rebleeding Within 30 Days as Judged by the EpC||Within 30 days|||Participants|||Number
715350|NCT00251979|Secondary|Death Within 30 Days||Within 30 days|||Participants|||Number
715351|NCT00251979|Secondary|Death Within 72 Hours||Within 72 hours|||Participants|||Number
715352|NCT00251979|Secondary|Clinically Significant Rebleeding Within 30 Days||Within 30 days|||Participants|||Number
715353|NCT00251979|Secondary|Clinically Significant Rebleeding Within 7 Days||Within 7 days|||Participants|||Number
715354|NCT00251979|Primary|Clinically Significant Rebleeding Within 72 Hours of Continous Infusion of Esomeprazole or Placebo||Within 72 hours|||Participants|||Number
715355|NCT00252057|Primary|Total Number of Rehospitalizations (Emergency Department Visits Plus Hospital Admissions) in the 30 Days After Discharge.|The total number of rehospitalizations (emergency department visits plus hospital admissions) in the 30 days after discharge, compared across study arms. Participants could have more than one rehospitalization in this period; all rehospitalizations for each were counted, making the unit of measure the rehospitalizations and not the participants.|30 days after discharge|||Total number of rehospitalizations|||Number
715356|NCT00252174|Secondary|Beck Hopelessness Scale (BHI)|Established self-report measure of depression and hopelessness, consisting of 20 true-false questions, with scores ranging from 0 to 20, with scores of 0-3 indicating minimal hopelessness and scores of 15-20 severe hopelessness.|Obtained over 3 months of study||||||
715357|NCT00252174|Secondary|Daily Assessment of Anxiety - the Visual Analog Anxiety Scale (VAAS)|Daily self-report measure for anxiety.|Obtained over the 3 months of active participation|Data has been damaged/lost in a flood that destroyed the office that contained much of the primary source material|||||
715358|NCT00252174|Secondary|The Hospital Anxiety and Depression Scale (HADS)|"Standardized assessment of anxiety and depression consisting of a 7-item anxiety scale and a 7-item depression scale. Each scale score ranges from 0 to 21, with 0-7 being normal and 11-21 being abnormal [e.g. severely depressed or anxious]"|Obtained over the 3 months of active participation|Data has been damaged/lost in a flood that destroyed the office that contained much of the primary source material|||||
715359|NCT00252174|Secondary|Daily Experience of Pain - Visual Analog Pain Scale (VAPS)|daily measure of self-reported pain.|Obtained over the 3 months of active participation|Data has been damaged/lost in a flood that destroyed the office that contained much of the primary source material|||||
715360|NCT00252174|Secondary|Daily Use of Anxiolytics - Daily Diary|daily log of anxiolytic medication usage.|Obtained over the 3 months of active participation|Data has been damaged/lost in a flood that destroyed the office that contained much of the primary source material|||||
715361|NCT00252174|Secondary|Depression, Thoughts of Death - Schedule of Attitudes Toward Hastened Death (SAHD)|standardized questions to evaluate extent of depression and thoughts of death.|Obtained over the 3 months of active participation|Data has been damaged/lost in a flood that destroyed the office that contained much of the primary source material|||||
715362|NCT00252174|Secondary|Hamilton Depression Rating Scale (HAM-D)|Standardized interview assessing of depression, with higher scores indicative of greater depression. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2.|Obtained over the 3 months of active participation|Data has been damaged/lost in a flood that destroyed the office that contained much of the primary source material|||||
715363|NCT00252174|Secondary|Quality of Life - Functional Assessment of Chronic Illness Therapy- Spiritual Well-being Scale (FACIT-Sp),Karnofsky Performance Rating Scale (KPRS), Memorial Symptom Assessment Scale (MSAS), Mini-Mental Status Exam (MMSE), Self-Expansiveness Level Form|paper pencil tests capturing data on spiritual well-being, overall functioning living with cancer, psychiatric mental status, and on spiritual self-perception.|Obtained over the 3 months of active participation|Data has been damaged/lost in a flood that destroyed the office that contained much of the primary source material|||||
715364|NCT00252174|Secondary|Anxiety - Hamilton Anxiety Rating Scale (HAM-A)|standardized assessment of anxiety|Obtained over the 3 months of active participation|Data has been damaged/lost in a flood that destroyed the office that contained much of the primary source material|||||
715365|NCT00252174|Primary|Quality of Life - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)|"Self-report instrument assessing quality of life with five functional scales, and nine symptom scales. Higher functional scores indicate better quality of life and higher symptom scores indicate poorer quality of life. Scales include Yes / No responses and four-point Likert scales, with transformations performed on scores so that all scale scores range from 0 to 100."|Obtained over the 3 months of active participation|Data has been damaged/lost in a flood that destroyed the office that contained much of the primary source material|||||
715371|NCT00252187|Secondary|Change in Renal Function as Measured by Glomerular Filtration Rate (GFR) at 8 Weeks|Kidney function was measured by GFR determined by iothalamate clearance. Glomerular filtration rate describes the flow rate of filtered fluid through the kidney measured in milliliters per minute per 1.73 m^2 of body-surface area. A lower GFR means the kidney is not filtering normally.|Baseline and 8 weeks|Per protocol population||ml/min/1.73 m^2 of body-surface area||Standard Deviation|Mean
715372|NCT00252187|Secondary|Change in Plasma Renin Activity at 8 Weeks|Plasma renin is synthesized within circulation or at tissue sites, causing vasoconstriction or vasodilation.|Baseline and 8 weeks|Per protocol population||nanograms per milliliter per hour||Standard Deviation|Mean
715373|NCT00252187|Secondary|Change in Left Ventricular (LV) Filling Pressure at 8 Weeks|Filling pressure determined by ratio of E/e' [Echocardiograph Doppler mitral inflow velocity (E) to mitral annulus tissue Doppler velocity (e') ratio]|Baseline and 8 weeks|Per protocol population||E/e'||Standard Deviation|Mean
715374|NCT00252187|Primary|Change in Left Ventricular (LV) Volume Index at 8 Weeks|LV volume was measured for systolic volume and diastolic volume using a cardiac Magnetic Resonance Imaging (MRI) scan. All cardiac MRI images were reviewed by an independent cardiologist in a blinded fashion.|Baseline and 8 weeks|Per protocol population||ml/m^2||Standard Deviation|Mean
715375|NCT00252239|Primary|Functional Handicap (Modified Rankin Score)|The scale range is from 0 (perfect health without symptoms) to 6 (death). Percentage of participants with Modified Rankin Score >=4 are reported.|3 months|||percentage of participants|||Number
715376|NCT00252967|Secondary|Comparison of Tumor Necrosis Factor Alpha Values||Baseline and 30 days|||ng/mL||Inter-Quartile Range|Median
715377|NCT00252967|Secondary|Comparison of High Sensitivity C-reactive Protein||Baseline and 30 days|||mg/L||Inter-Quartile Range|Median
715378|NCT00252967|Secondary|Comparison of Interleukin-1 Values||Baseline and 30 days|||ng/mL||Inter-Quartile Range|Median
715379|NCT00252967|Secondary|Comparison of Interleukin-6 Values||Baseline and 30 days|||ng/mL||Inter-Quartile Range|Median
715380|NCT00252967|Secondary|Comparison of Isoprostanes Values||Baseline and 30 days|||pg/mL||Inter-Quartile Range|Median
715381|NCT00252967|Secondary|Comparison of Derivatives of Reactive Oxygen Metabolites Values||Baseline and 30 days|||Carr||Inter-Quartile Range|Median
715382|NCT00252967|Secondary|Comparison of Redox Potential for Glutathione Values||Baseline and 30 days|||mV||Inter-Quartile Range|Median
715383|NCT00252967|Secondary|Comparison of Redox Potential for Cysteine Values||Baseline and 30 days|||mV||Inter-Quartile Range|Median
715384|NCT00252967|Primary|Time of Atrial Fibrillation Recurrence||Upon recurrence, up to 12 months|||days||Inter-Quartile Range|Median
715385|NCT00253019|Primary|Continuation Rates|We followed subjects to evaluate the continuation rates for subjects receiving oral contraceptive pills, Depo Provera and Ortho Evra.|3 months|It was a convenience sample.||participants|||Number
715386|NCT00253370|Secondary|Overall Survival (OS)|Overall survival was defined as the time from registration to death from any cause.|Assessed every 3 months if patient is < 2 years from study entry; then every 6 months if patient is 2-3 years from study entry.|All enrolled patients started treatment and were considered eligible and hence were all included in the analysis.||Months||90% Confidence Interval|Median
715387|NCT00253370|Secondary|Progression-free Survival (PFS)|"Progression-free survival was defined as the shorter of:
The time from registration to progression. or
The time from registration to death without documentation of progression given that the death occurs within 4 months of the last disease assessment without progression (or registration, whichever is more recent).
Therefore, cases not meeting either of the criteria for a PFS event are censored at the date of last disease assessment without progression (or registration, whichever is more recent).
Progression is defined as at least 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s) or unequivocal progression of existing non-target lesions."|Assessed every 6 weeks until disease progression or up to 3 years|All enrolled patients started treatment and were considered eligible and hence were all included in the analysis.||Months||90% Confidence Interval|Median
715388|NCT00253370|Primary|The Proportion of Patients With Objective Response (Complete Response or Partial Response)|Response was evaluated using RECIST (Response Evaluation Criteria in Solid Tumors) 1.0 criteria. Per RECIST criteria, complete response (CR) = disappearance of all target and non-target lesions. Partial response (PR)= >=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits. Objective response = CR + PR.|Assessed every 6 weeks until disease progression or up to 3 years|All enrolled patients started treatment and were considered eligible and hence were all included in the analysis.||Proportion of patients||90% Confidence Interval|Number
715389|NCT00253435|Secondary|Dose Limiting Veno-occlusive Disease (VOD) / Sinusoidal Obstruction Syndrome SOS|"Dose limiting veno-occlusive disease (VOD) defined as:
the presence of hepatomegaly with right upper quadrant tenderness and an elevation of total bilirubin > grade 1, PLUS
the presence of grade 3 abnormalities of any ONE of the following: total bilirubin, hypoalbuminemia, weight gain, or hypoxia without other attribution"|Between start of MIBG treatment and 60 days post stem cell infusion|All patients who began treatment||participants|||Number
715390|NCT00253435|Secondary|Engraftment DLT|"• Engraftment toxicity: delayed engraftment and/or failure to engraft defined as:
neutrophils (ANC) < 500/μL by day 28 post transplant, or
platelets < 20,000 /μL by day 56 post transplant, or
if additional stem cells are required to be infused for any medical reason prior to initial engraftment of neutrophils or platelets."|From treatment start until 60 days post stem cell infusion|All patients who began treatment||participants|||Number
715391|NCT00253435|Secondary|Event-free Survival (EFS) at 3 Years|EFS will be measured from start of treatment until progression, death or start of another treatment - whichever comes first. We report the estimated probability of EFS at 3 years.|3 years since start of treatment|Estimated probability of 3-year progression free survival for all patients enrolled in each risk group.||Estimated probability|||Number
715495|NCT00255151|Secondary|Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Median.|The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was reported.|6 months|The analysis of 24-hour heartburn-free days was performed on ITT subjects with at least one daytime or nighttime heartburn Yes/No question answered during treatment.||Percentage of Days||Inter-Quartile Range|Median
715392|NCT00253435|Primary|Response (Complete Response, Very Good Partial Response, and Partial Response) at 60-days Post Stem Cell Infusion|Tumor response based on evaluation performed on day 60 or at the time of disease progression/recurrence or start of another treatment - whichever comes first. Such evaluations will include 123I-MIBG scan, CT/MRI, urine catecholamine measurement, and bone marrow analysis (for those with marrow disease at study entry).|Response assessed 60 days post stem cell infusion|One patient in the Poor Risk Cohort underwent surgery for resection (of his only measureable lesion) prior to post-treatment assessment and is not evaluable for response.||participants|||Number
715393|NCT00253448|Primary|Overall Survival After Treatment|Followed every 3 months for 2 years, every 6 months for 3 years, and annually thereafter for at least 5 years|Minimum of 5 years.|||months||95% Confidence Interval|Median
715394|NCT00253513|Secondary|Number of Subjects Who Are Without Disease at One Year as Indicator of Disease Free Survival.||One year|||participants|||Number
715395|NCT00253513|Primary|Incidence (Percent of Participants) With Nonrelapse Mortality (NRM) by Day 200 (Secondary Phase Only)|NRM (Non relapse mortality) - death not attributed to the primary cancer.|200 days|||percent of participants||95% Confidence Interval|Number
715396|NCT00253513|Primary|Number of Patients Experiencing Graft Failure|Graft versus Host Disease (GVHD) is a frequent complication of allogeneic bone marrow transplant in which the engrafted donor cells attacks the patient's organs and tissue. Acute GVHD (aGVHD) usually occurs during the first three months following an allogeneic BMT. Chronic GVHD (cGVHD) usually develops after the third month post-transplant. Patients may experience one, both or neither.|42 days|For graft failure 2 of the 60 patients were not evaluable because they exeperienced another event (relapsed) before they could be evaluable for graft failure.||participants|||Number
715397|NCT00253513|Primary|Number of Patients Experiencing Regimen-related Toxicity Events in Study Population|Proportion of patients experiencing regimen-related toxicity to major organ systems from day minus 6 to day 28. Major organ systems: cardiac, bladder/renal, pulmonary, hepatic, neurologic and gastrointestinal|34 days and 2 years|||participants|||Number
715398|NCT00253643|Primary|Cell Proliferation by Ki67-immunohistochemistry at Pre- and Post-intervention|Cell Proliferation by Ki67 is calculated as the percent stained by immunohistochemistry. Ki-67 values were log-transformed because the original distribution was skewed. Analysis was done on log-base2 transformed values.|End of study|Number of participants for recruitment was based on power calculations. All participants consented and randomized were included in analyses. Analysis was intention to treat. No imputations for missing data were conducted.||%age of cells & nuclei stained||Full Range|Median
715399|NCT00253643|Primary|Fatty Acid Synthase Expression by Immunohistochemistry at Pre- and Post-intervention (FAS Summary Score)|Sections of paraffin-embedded prostate biopsy tissue were stained for fatty acid synthase (FAS) expression. The FAS Summary Score was calculated as the product of percent stained (1=0-25%, 2=25-50%, 3=51-75%, 4=76-100%) and stain intensity (0-3) by immunohistochemistry. The range of the product is 0-300.|Baseline (pre-intervention) and end of study (time to surgery for those with malignant findings or up to 8 weeks for those with benign biopsies, post-intervention)|Number of participants for recruitment was based on power calculations. All participants consented and randomized were included in analyses. Analysis was intention to treat. No imputations for missing data were conducted.||units on a scale||Standard Deviation|Mean
715400|NCT00253708|Secondary|Sleep|Sleep (Richards-Campbell) 0 = best sleep to 50 = worst sleep|From baseline to 1 week and from baseline to 1 month|||units on a scale||Inter-Quartile Range|Median
715401|NCT00253708|Secondary|Quality of Life: McGill Total|Quality of Life (McGill Total); Mean of five sub-measures (but not overall) (0 = negative to 10 = positive)|From baseline to 1 week and from baseline to 1 month|||units on a scale||Inter-Quartile Range|Median
715402|NCT00253708|Secondary|Quality of Life: Psychological Well-being|Psychological well-being over past 2 days (depressed, nervous/worried, sad, terrified of future) (0= always/extremely to 10= never/not at all; in other words: 0=negative/worst to 10= positive/best)|From baseline to 1 week and from baseline to 1 month|||units on a scale||Inter-Quartile Range|Median
715403|NCT00253708|Secondary|Quality of Life: Physical Well-being|Physical well-being over past 2 days (0= physically terrible to 10= physically well)|From baseline to 1 week and from baseline to 1 month|||units on a scale||Inter-Quartile Range|Median
715404|NCT00253708|Primary|Alertness|0=not at all alert to 10=most alert|From baseline to 1 week and from baseline to 1 month|||units on a scale||Inter-Quartile Range|Median
715405|NCT00253708|Primary|Anxiety|0=no anxiety to 10=most severe anxiety|From baseline to 1 week and from baseline to 1 month|||units on a scale||Inter-Quartile Range|Median
715406|NCT00253708|Primary|Pain|0=no pain to 10=most severe pain|From baseline to 1 week and from baseline to one month|||units on a scale||Inter-Quartile Range|Median
715407|NCT00253747|Secondary|Point-prevalence Abstinence|A logistic regression including site and treatment group will be used to model rates of achieving point prevalence abstinence as assessed at the final visit of the O-MPH/P-Stnd Smoking Tx phase. Point prevalence abstinence was defined as not smoking in the previous seven days based on self-report using the TLFB method and confirmed with a Carbon Monoxide (CO) level <8 ppm.|Week 11|Evaluable population determined as for primary outcome.||participants|||Number
715408|NCT00253747|Secondary|Diagnostic and Statistical Manual-IV(DSM-IV) ADHD Rating Scale|A Generalized Estimating Equations(GEE)model which included treatment group, week, site, and treatment by week and site by week interaction effects was used to compare the groups on the DSM-IV ADHD total severity score (18 domains score at severity levels of 0[none]-3[severe]; maximum score 54) as measured at screening/baseline and study weeks 1-4 using the the interviewer-administered DSM-IV checklist and by the severity portion of the National Institute of Mental Health Clinical Global Impression (CGI) scale to rate the severity of the participant’s ADHD symptoms. A single severity score ranging from 1 to 7 is yielded by the CGI severity scale.|Baseline and Study weeks 1,4,7,9,11|Evaluable participants determined using criteria for same in the primary outcome.||DSM IV ADHD Score||Standard Deviation|Mean
715493|NCT00255151|Primary|Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Life Table Method|Percentage of subjects who maintained complete healing of erosive esophagitis as assessed by endoscopy. In the life table method, subjects without post-baseline endoscopy were included as censored; subjects who did not have a recurrence of EE and did not complete the study were also considered censored.|6 months|Life table method for the maintenance rate of healed EE was performed on ITT subjects and included subjects without post-baseline endoscopy as censored.||Percentage of Subjects|||Number
715409|NCT00253747|Primary|Prolonged Abstinence|The smoking quit date was considered the first day of the O-MPH/P-Stnd Smoking Tx phase, which lasted for 6 weeks or more precisely 42 days (i.e., approximately weeks 5-10). The grace period was the first two weeks (i.e., days 1-14) with the remaining four weeks (days 15-42) comprising the period in which the participant must not meet criteria for treatment failure in order to be scored as obtaining prolonged abstinence. Self-report of cigarette use was assessed using a time-line follow-back (TLFB) assessment using carbon monoxide (CO)levels to correct self-reported smoking days. “Smoking days” were determined by starting with self-reported smoking and non-smoking days and using CO levels measured at weekly visits to modify the self-reports.|Weeks 7-10|Randomized participants who complete at least two visits during the first four weeks following randomization, who reach the full dose of OROS-MPH /Placebo, who have a OROS-MPH /placebo medication compliance rate of at least 75% each week for study weeks 4 through 10, and who attend at least one meeting after initiating the nicotine patch.||participants|||Number
715410|NCT00253890|Primary|Sleep Quality, as Measured by Total Sleep Time|Number of minutes spent sleeping during sleep period, as measured by daily sleep diary.|Baseline to 1-month|Intent to Treat||minutes||Standard Deviation|Mean
715411|NCT00253981|Primary|Visual Analog Scale|Numeric scale based on pain level (1-10). The higher the numeric value, the higher the pain level, as perceived by the participant.|4 weeks||||||
715412|NCT00254072|Primary|Number of Participants With Postoperative Gastrointestinal Hemorrhage||30 days|||participants|||Number
715413|NCT00254163|Secondary|Progression-free Survival (PFS) Rate at 2-year|PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date.|24 months after registered.|Per protocol population||Probability of Progression-free Survival||95% Confidence Interval|Number
715414|NCT00254163|Secondary|Progression-free Survival (PFS) Rate at 1-year|PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date|12 months after registered.|Per protocol population||probability of Progression-free Survival||95% Confidence Interval|Number
715415|NCT00254163|Secondary|Objective Remission Rate (ORR)|"Complete remission (CR) see Outcome Measure 6. Partial remission (PR) must exhibit criteria 1 and 2 as well as one or more of the remaining features for at least 2 months.
≥50% decrease in peripheral blood lymphocyte count from the pretreatment baseline value.
≥50% reduction in lymphadenopathy.
≥50% reduction in the size of the liver and/or spleen.
Polymorphonuclear leukocytes ≥ 1,500/mm^3 or 50% improvement over baseline.
Platelets >100,000/mm^3 or 50% improvement over baseline.
Hemoglobin >11.0 g/dL or 50% improvement over baseline without transfusions. Nodular partial remission (nPR) is defined as a CR with persistent bone marrow nodules; Objective Remission (OR) = CR + PR + nPR."|6 cycles of 28-day for FCR and 8 cycles of 21-day for PCR, or until PD, CR, or intolerable toxicity|Per protocol population||percentage of participants||95% Confidence Interval|Number
715416|NCT00254163|Secondary|Complete Remission (CR)|"Definitions of response is evaluated using guidelines proposed by the National Cancer Institute-Sponsored Working Group for Chronic Lymphocytic Leukemia.
Complete remission (CR) requires all of the following for a period of at least 2 months:
Absence of lymphadenopathy by physical examination and appropriate radiographic techniques. Lymph nodes must be <1 cm.
No evidence of hepatomegaly or splenomegaly.
Absence of constitutional symptoms.
Normal CBC as exhibited by:
Polymorphonuclear leukocytes ≥ 1,500/mm^3
Platelets > 100,000/mm^3
Hemoglobin > 11.0 g/dL (untransfused)
Bone marrow aspirate and biopsy should be performed 2 months after clinical and laboratory results demonstrate that all of the requirements listed in 1-4 have been met to demonstrate that a CR has been achieved. The marrow sample must be at least normocellular for age, with less than 30% of the nucleated cells being lymphocytes.
Lymphoid nodules should be absent."|6 cycles of 28-day for FCR and 8 cycles of 21-day for PCR, or until PD, CR, or intolerable toxicity|Per protocol population||percentage of participants||95% Confidence Interval|Number
715417|NCT00254163|Secondary|Mean Absolute Neutrophil Count (ANC) at Post-treatment|mean Absolute Neutrophil Count (ANC) measured 2 months (8-10 weeks) following the last dose of study treatment|2 months post-treatment|Per protocol population||10^3 cells/mm^3||Standard Deviation|Mean
715418|NCT00254163|Secondary|Hematologic Recovery|defined as Hb >11g/dL and a platelet count >100 × 10^3/mm^3|2 months post-treatment|Per protocol population||percentage of participants||95% Confidence Interval|Number
715419|NCT00254163|Secondary|Percentage of Patients Hospitalized|Percentage of patients who were hospitalized due to any reasons during the study period.|6 cycles of 28-day for FCR and 8 cycles of 21-day for PCR, or until PD, CR, or intolerable toxicity|Per protocol population||percentage of participants|||Number
715420|NCT00254163|Secondary|Infective Event Rate|infective events=temperature >101 without symptoms or temp <101 with symptoms|6 cycles of 28-day for FCR and 8 cycles of 21-day for PCR, or until PD, CR, or intolerable toxicity|Per protocol population||percentage of infective events|||Number
715421|NCT00254163|Primary|Infection Rate|infection=febrile events requiring treatment|6 cycles of 28-day for FCR and 8 cycles of 21-day for PCR, or until PD, CR, or intolerable toxicity|Per protocol population||percentage of participants||95% Confidence Interval|Number
715422|NCT00254293|Secondary|Overall Study ST and LTE Periods: Number of Participants With Anti-abatacept Antibodies and/or Anti-cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Antibodies|Assessment of positive antibody response based upon analysis using a validated enzyme-linked immunosorbent assay (ELISA) with a cut-off value. CTLA4 is a protein receptor that downregulates the immune system. Short Term (ST) period was initial 12 Weeks of the study. Overall LTE includes both the variable and fixed abatacept dosing periods and was from the end of the ST period (Day 85) up to 168 days post last dose (treatment in LTE ranged from 4.4 to 74.2 months. Data in the ST period are summarized by the treatment the participants actually received, while the LT period data are summarized by treatment the participant was randomized to receive.|ST: Day 1 to Day 85; LTE: Day 85 to 168 days post last dose|In the ST period, only subjects treated with abatacept (51) were evaluated for antibodies. In LTE, 61 participants were analyzed for anti-abatacept antibodies, and 62 participants were analyzed for CTLA4-T antibodies. Participants were analyzed during treatment and post-treatment (28, 56, 85, and 168 days post-treatment).||participants|||Number
716547|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Change Value in LDL Cholesterol (Fasting), Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement||mg/dL||Full Range|Median
715423|NCT00254293|Primary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, Discontinuations Due to Adverse Events Summarized Over the Entire Long Term Extension (LTE) Period (Both Variable and Fixed Dosing)|On Day 85 participants rolled over into the LTE with variable dose phase first and at Day 533, a fixed dose phase of 125 mg abatacept SC weekly, irrespective of body weight. This summary includes AEs reported during entire LTE treatment plus 56 days post last dose; includes all deaths reported during the LTE including those that occurred greater than 56 days after last dose. MedDRA version: 15.1. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization (also included hospitalizations for elective surgical procedures). Treatment-related=having certain, probable, possible, or missing relationship to study drug.|Day 533 to 56 Days Post last dose|total number of participants in the Long Term Extension Period.||participants|||Number
715424|NCT00254293|Secondary|Short Term Period: Mean Change From Screening at Day 85 in ECG (Heart Rate) After SC Administration of Abatacept or Placebo in Participants With Rheumatoid Arthritis Receiving DMARDS|A 12-lead electrocardiogram (ECG) was recorded at screening and at discharge from the study (Day 85 or 7 days after the last dose of study drug for those subjects who terminated early). If there was no history of known cardiac events, an ECG was performed within 6 months of study entry, and documentation was on file, then the screening ECG was not repeated at screening. Heart Rate was reported in beats per minute (bpm). In no ECG issues were found in the 12 weeks of the Short Term Period, ECG was not repeated during LTE. Data are presented by treatment the participant actually received, not by what they were randomized to receive.|Screening to Day 85 (or early termination)|A total of 68 participants were treated with abatacept or placebo: 65 had results at screening and 53 had results at Discharge (Day 85) for Heart Rate.||bpm||Standard Deviation|Mean
715425|NCT00254293|Primary|Number of Participants With Pre-specified AEs of Special Interest in the Variable Dosing Phase of Long Term Extension (LTE)|LTE period with variable abatacept dosing starting on Day 85 and continuing until Day 533 when LTE fixed dosing started. AEs of special interest: infection and/or infestation; neoplasms (malignant); pre-specified autoimmune disorder; infusional AEs (peri-infusional: pre-specified AEs occurring during first 24 hours (hrs) after start of the IV loading dose; acute infusional: pre-specified AEs occurring during the first hour after the start of the IV loading dose; systemic injection site reactions (SIR): pre-specified AEs for SIR; local injection site reaction: pre-specified AEs for local site reaction. Data are presented by treatment the participant was randomized to and not what they actually received.|Day 85 to Day 533|All 63 participants who completed the ST period enrolled into the LTE variable dosing period and were analyzed.||participants|||Number
715426|NCT00254293|Secondary|Short Term Period: Mean Change From Screening to Day 85 in Electrocardiogram (QT, PR Intervals, QRS Width) After SC Administration of Abatacept or Placebo in Participants With Rheumatoid Arthritis Receiving DMARDS|A 12-lead electrocardiogram (ECG) was recorded at screening and at discharge from the study (Day 85 or 7 days after the last dose of study drug for those subjects who terminated early). If there was no history of known cardiac events, an ECG was performed within 6 months of study entry, and documentation was on file, then the screening ECG was not repeated at screening. QT interval, PR interval and QRW Width were reported in milliseconds (msec). If no ECG issues were found in the 12 weeks of the Short Term Period, ECG was not repeated during LTE. Data are presented by treatment the participant actually received, not by what they were randomized to receive.|Screening to Day 85 (or early termination)|A total of 68 participants were treated with abatacept or placebo: 66 had results at screening and 52 had results at Discharge (Day 85) for QT interval and QRS Width; 65 and 51 participants had PR interval results at Screening and Discharge (Day 85), respectively.||msec||Standard Deviation|Mean
715427|NCT00254293|Secondary|Short Term Period: Mean Change From Baseline at Day 85 in Pulse Rate After SC Administration of Abatacept or Placebo in Participants With Rheumatoid Arthritis Receiving DMARDS|Pulse rate was taken while participant was seated. Pulse rate was recorded during the screening visit, at baseline on Day 1 (prior to administration of IV infusion), prior to administration of all SC injections, and at study discharge (Day 85 or 7 days after the last dose for subjects who terminated early). In addition, vital signs were recorded at 30 and 60 minutes after the start of the IV infusion on Day 1, and 30 and 60 minutes after all SC injections. Pulse rate measured in beats/min (bpm). Data are presented by treatment the participant actually received, not by what they were randomized to receive.|Day 1 to Day 85 (or early termination)|All participants who were treated with abatacept or placebo and had vital signs taken were analyzed throughout the 12 weeks. At Day 85 N = 6, 3, 28, 6, 5, 17 in groups 1, 2, 3, 4, 5, Placebo, respectively||bpm||Standard Deviation|Mean
715428|NCT00254293|Secondary|Short Term Period: Mean Change From Baseline at Day 85 in Blood Pressure After SC Administration of Abatacept or Placebo in Participants With Rheumatoid Arthritis Receiving DMARDS|Blood pressure (systolic and diastolic) was recorded while the participant was seated during the screening visit, at baseline on Day 1 (prior to administration of IV infusion), prior to administration of all SC injections, and at study discharge (Day 85 or 7 days after the last dose for subjects who terminated early). In addition, blood pressure was recorded at 30 and 60 minutes after the start of the IV infusion on Day 1, and 30 and 60 minutes after all SC injections. Blood pressure was measured in millimeters of mercury (mm Hg). Data are presented by treatment the participant actually received, not by what they were randomized to receive.|Day 1 to Day 85 (or early termination)|All participants who were treated with abatacept or placebo and had vital signs taken were analyzed throughout the 12 weeks. At Day 85 N = 6, 3, 28,6, 5, 17 in groups 1, 2, 3, 4, 5, Placebo, respectively||mm Hg||Standard Deviation|Mean
715435|NCT00254293|Secondary|Short Term Period: Area Under the Curve (AUC) in Time Interval of 7 Days [AUC(TAU)] of Abatacept in Participants With Rheumatoid Arthritis Receiving DMARDS|The steady-state pharmacokinetic parameter AUC(TAU) of abatacept after weekly SC administration was determined between the SC dosing interval from Day 71 to 78 (TAU=7 days). Abatacept in human serum was measured by enzyme-linked immunosorbent assay (ELISA). Lower limit of quantification (LLOQ) was 0.001; Upper limit of quantification (ULOQ) was 0.030. AUC(TAU) measured in in micrograms*hours per milliliter (µg*h/mL). Data are presented by treatment the participant actually received, not by what they were randomized to receive.|Day 71 to Day 78|Pharmacokinetic (PK) analysis set included those participants treated with abatacept and having PK data available.||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
715429|NCT00254293|Secondary|Short Term Period: Number of Participants With Laboratory Abnormalities in Serum Chemistry at Baseline and on Treatment up to Day 85|Screening, BL, Days 15, 29, 57, 85 or discharge. Upper limit of normal (ULN). CTC grade (Gr): Alanine transaminase Gr 1:>ULN to 2.5*ULN; Gr 2: >2.5 to 5.0*ULN; Gr 3: >5.0 to 20.0*ULN; Gr 4: >20.0*ULN. Aspartate aminotransferase Gr 1: >ULN to 2.5*ULN; Gr 2:>2.5 to 5.0*ULN; Gr 3: >5.0 to 20.0*ULN; Gr 4: >20.0*ULN. G-Glutamyl Transferase (U/L) Gr 1:>ULN to 2.5*ULN; Gr 2: >2.5 to 5.0*ULN; Gr 3: >5.0 to 20.0*ULN; Gr 4: >20.0*ULN. Alkaline phosphatase (U/L) Gr 1:>ULN to 2.5*ULN, Gr2:>2.5 to 5.0*ULN, Gr3:>5.0 to 20.0*ULN, Gr4: >20.0*ULN; creatinine (mg/dL) Gr 1: >ULN to 1.5*ULN; Gr 2: >1.5 to 3.0*ULN; Gr 3: >3.0 to 6.0*ULN; Gr 4: >10.0*ULN. Albumin (g/dL) Gr 1:<LLN to 3.0; Gr 2:<3.0 to 2.0; Gr 3: <2.0. Uric Acid (mg/dL)Gr 1: >1.0 x ULN to 10.0; Gr 4: >10.0. Sodium (mEq/L) Gr 1: >ULN to 150; Gr 2: >150 to 155; Gr 3: >155 to 160; Gr 4: > 160. Potassium (mEq/L) Gr 1: >ULN to 5.5; Gr 2: >5.5 to 6.0; Gr 3: >6.0 to 7.0; Gr 4: >7.0. Data presented by treatment participant actually received.|Day 1 to Day 85 (or early termination)|All participants treated with abatacept or placebo in the short term period. Participant is counted once in total but could have multiple AEs of different grade. Grade category is number of participants with that Grade of AE (Grades 1, 2, 3, 4)||participants|||Number
715430|NCT00254293|Secondary|Short Term Period: Number of Participants With Laboratory Abnormalities in Hematology at Baseline (Day 1) to End of Period (Day 85)|Blood samples were obtained: At screening, within 24 hours prior to study drug administration on Day 1, on Days 15, 29, 57 and at study discharge. Baseline (BL) defined as Day 1 prior to treatment. Common toxicity criteria (CTC), Version 3 used to assess parameters. lower limit of normal (LLN). ANC=absolute neutrophil count. White blood cells Grade (Gr) 1:<LLN to 3.0*10^9/L, Gr 2:<3.0 to 2.0*10^9/L, Gr 3:<2.0 to 1.0*10^9/L, Gr 4:<1.0*10^9/L. ANC Gr 1:<LLN to 1.5*10^9/L, Gr 2:<1.5 to 1.0*10^9/L, Gr 3:<1.0 to 0.5*10^9/L, Gr 4:<0.5*10^9/L. Lymphocytes Gr 1: <LLN to 3.0, Gr 2: 2.0 < 3.0, Gr 3: 1.0 to < 2.0, Gr 4; < 1.0. Platelet count Gr 1:LLN to 75.0*10^9/L, Gr 2:<75.0 to 50.0*10^9/L, Gr 3:<50.0 to 25.0*10^9/L, Gr 4:<25.0 to 10^9/L. Hemoglobin Gr 1:<LLN to 10.0 g/dL, Gr 2:<10.0 to 8.0 g/dL, Gr 3:<8.0 to 6.5 g/dL, Gr 4:<6.5 g/dL. Hematocrit (%): <0.75*pre-treatment. Data are presented by treatment the participant actually received, not by what they were randomized to receive.|Day 1 to Day 85 (or early termination)|All participants treated with either abatacept or placebo. Participant counted once in total for each arm but participant could have multiple AEs of different grade. Grade category is number of participants with that Grade of AE (Grades 1, 2, 3, 4)||participants|||Number
715431|NCT00254293|Secondary|Short Term Period: Mean Percent Change From Baseline on Day 85 in Participants Positive for Serum Rheumatoid Factor During Abatacept or Placebo Administration|Serum samples were obtained on Days 1, 8, 15, 29, 57 and day of discharge (Day 85 or earlier) for determination of presence of rheumatoid factor (RF). Baseline was defined as Day 1 to calculate percent change. Lower limit of quantitation (LLQ) was 5 Units/milliliter (U/mL). Values below LLQ were set to 2.5 U/mL. Data are presented by treatment the participant actually received, not by what they were randomized to receive.|Day 1 to Day 85 (or early termination)|Analysis set included all available data from participants who received abatacept or placebo. For RF analysis in Group 1 Day 1/Day 85 number of participants = 7/7; Group 2 = 3/3; Group 3 = 29/29; Group 4 = 6/6; Group 5 = 5/5; Placebo = 17/15 participants.||percentage of change from baseline||Standard Deviation|Mean
715432|NCT00254293|Secondary|Short Term Period: Number of Participants With Pre-specified Adverse Events (AEs) of Special Interest After Administration of Abatacept or Placebo Over 12 Weeks|AEs of special interest: infection and/or infestation; neoplasms (benign, malignant, unspecified; autoimmune disorder; infusional AEs (peri-infusional: AEs occurring during first 24 hours (hrs) after start of the IV loading dose; acute infusional: AEs occurring during the first hour after the start of the IV loading dose; injection site AEs: AEs occurring at the site of the SC injection. Data are presented by treatment the participant actually received, not by what they were randomized to receive.|Day 1 to Day 85 (or early termination)|All subjects treated were analyzed for safety.||participants|||Number
715433|NCT00254293|Secondary|Short Term Period: Summary of Adverse Events (AEs), Serious AEs, Deaths, and Discontinuations Due to AEs During 12 Weeks of Treatment With Either Abatacept or Placebo|Number of Participants with Adverse events (AEs), Serious AEs, discontinuations due to AEs, or Deaths occurring while participant was on treatment from Day 1 (treatment) to Day 85 or early termination from the study. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization (also included hospitalizations for elective surgical procedures). Data are presented by treatment the participant actually received, not by what they were randomized to receive.|Day 1 to Day 85 (or early termination)|||participants|||Number
715434|NCT00254293|Primary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, Discontinuations Due to Adverse Events Reported During the Variable Dosing Phase of the Long Term Period (LTE)|AEs during variable dose phase of LTE + 56 days post last dose in the variable dose phase or start of the fixed dose phase, which ever came first; includes deaths reported during the variable dose phase including those that occurred greater than 56 days after last dose. Medical Dictionary for Regulatory Activities (MedDRA) version: 15.1. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization (included hospitalizations for elective surgical procedures). Treatment-related=having certain, probable, possible, or missing relationship to study drug. Data presented by treatment the participant was randomized to and not what they actually received.|Day 85 to 56 days post last dose|Participants included those that rolled over into the LTE, receiving variable SC dosing of abatacept in the Variable Dose Period.||participants|||Number
715447|NCT00254540|Secondary|Trough Plasma Concentration (Ctrough) of SU-011248+SU-012662 in First-line Treatment Population|"SU-012662 is a metabolite of SU-011248. Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration.
The Ctrough for total drug (SU-011248+SU-012662) was calculated as the mean of the Ctrough of total drug from each individual subject."|Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 plasma concentration data for Pharmacokinetic analysis.
n=Number of subjects with analyzable data."||ng/mL||Full Range|Median
715436|NCT00254293|Secondary|Short Term Period: Peak Serum Concentration (Cmax) of Abatacept at Steady State in Participants With Rheumatoid Arthritis Receiving DMARDS|Peak serum concentration (Cmax) of abatacept after weekly SC administration was determined between the SC dosing interval from Day 71 to 78. Abatacept in human serum was measured by enzyme-linked immunosorbent assay (ELISA). Lower limit of quantification (LLOQ) was 0.001, Upper limit of quantification (ULOQ) was 0.030. Cmax measured in micrograms per milliliter(µg/mL). Data are presented by treatment the participant actually received, not by what they were randomized to receive.|Day 71 to Day 78|Pharmacokinetic (PK) analysis set included those participants treated with abatacept and having PK data available||µg/mL||Geometric Coefficient of Variation|Geometric Mean
715437|NCT00254293|Primary|Short Term Period: Steady-state Trough Serum Concentration (Cmin) of Abatacept Following Weekly Subcutaneous Dosing in Participants With Active Rheumatoid Arthritis Receiving Disease Modifying Anti-rheumatic Drugs (DMARDS)|Participants received abatacept while also receiving DMARDS over a short term (ST) 12 Week period. To eliminate contribution from the IV loading dose of abatacept during the short term study period, Cmin values were selected from Days 71 to 85, when contribution from IV was negligible. Minimum trough serum concentration of abatacept (Cmin) was measured in micrograms/milliliter (µg/mL). Data are presented by treatment the participant actually received, not by what they were randomized to receive.|Days 71 to 85|50 of the 51 abatacept-treated subjects were included. One subject who discontinued after receiving only Day 1 dosing was not included in this analysis.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
715438|NCT00254462|Secondary|Change in Total ADHD-IV Teacher|Measures 18 symptoms of ADHD. Each symptom rated 0-3, for a maximum total score of 54 for the scale. A higher score reflects more severe symptomatology.|Measured at baseline and at Week 8. Later time point is subtracted from earlier time point.|||units on a scale||Standard Error|Mean
715439|NCT00254462|Primary|Change in ADHD-IV Rating Scale Total Score|"Measures 18 symptoms of attention deficit hyperactivity disorder (ADHD). Each symptom rated 0-3, for a minimum total score of 0, and a maximum total score of 54 for the scale. A higher score reflects more severe symptomatology.
The inattentive subscale and the hyperactive/impulsive subscale each has a minimum score of 0 and maximum score of 27."|Measured at baseline and at Week 8. These are the only two timepoints calculated, later timepoint subtracted from earlier timepoint.|||units on a scale||Standard Error|Mean
715440|NCT00254501|Secondary|Change in Diabetes Knowledge and Empowerment (Patient Self-efficacy) From Baseline to 12 Months|"Psycho-social aspects of diabetes knowledge and empowerment. Sample sizes are in parentheses (usual care plus out-of-pocket cost waiver; EMPOWER group):
Changes from baseline to 12 months for the Diabetes Empowerment Scale (DES). Mean score for 28 items each scored as a Likert scale from 1 to 5. Higher scores correspond to greater empowerment
Changes from baseline to 12 months for the Adherence Starts with Knowledge (ASK-20) adherence barrier test total barrier score (TBC). The TBC has a range from 0 to 18 and higher scores correspond to greater barriers.
Changes from baseline to 12 months for understanding of diabetes. This is a single question: How would you rate your understanding of diabetes and its treatment? which uses a 7-point scale Likert scale as the response from 1 (poor) to 7 (excellent)."|From baseline to 12 months|The number of participants reported for each outcome reflects those participants who completed both baseline and 12-month surveys.||units on a scale||95% Confidence Interval|Mean
715441|NCT00254501|Secondary|Changes in Economic Outcomes (Total Cost of Care, Cost of Diabetes Medications, Cost of Diabetes Supplies) From Baseline to 12 Months|"Changes in claims-based economic data on costs of total health care, diabetes medications, and diabetes supplies from baseline to 12 months. Only participants who had a claim in the 12 months prior to baseline were included in these analyses. The resulting sample sizes (usual care plus out-of-pocket cost waiver; EMPOWER group) for these outcomes are:
Total cost of care
Costs of diabetes medications
Costs of diabetes supplies"|baseline to 12 months|Changes in claims-based data from baseline to 12 months among patients with at least one diabetes-related claim at baseline.||US dollars||95% Confidence Interval|Mean
715442|NCT00254501|Secondary|Changes From Baseline in LDL, HDL, Total Cholesterol, Triglycerides|"Changes from baseline in LDL, HDL, total cholesterol, triglycerides.
Sample sizes for each individual test (usual care plus out-of-pocket cost waiver; EMPOWER group):
LDL
HDL
Total cholesterol
Triglycerides"|baseline and 12 months|The number of participants reported reflects only those participants who had both baseline and 12-month lab tests.||mg/dl||95% Confidence Interval|Mean
715443|NCT00254501|Primary|Change in Hemoglobin A-1C From Baseline|Compare changes in Hemoglobin A-1C from baseline between the two groups.|baseline and 12 months|Specific employers were recruited and offered waiver of out-of-pocket costs for diabetes-related care to their employees to participate in the study. The number of participants reported reflects only those participants who had both baseline and 12-month lab tests.||percentage of glycolsylated hemoglobin||Standard Deviation|Mean
715444|NCT00254540|Secondary|Plasma Concentrations of Soluble Vascular Endothelial Growth Factor Type 2 Receptors (sVEGFR2)|Plasma concentrations of potential pharmacodynamic markers; Soluble Vascular Endothelial Growth Factor Type 2 Receptors (sVEGFR2)|Days 1, 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 plasma concentration data for Pharmacodynamic analysis.
n=Number of subjects with analyzable data."||pg/mL||Full Range|Median
715445|NCT00254540|Secondary|Plasma Concentrations of Vascular Endothelial Growth Factor (VEGF)|Plasma concentrations of potential pharmacodynamic markers; Vascular Endothelial Growth Factor (VEGF)|Days 1, 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 plasma concentration data for Pharmacodynamic analysis.
n=Number of subjects with analyzable data."||pg/mL||Full Range|Median
715446|NCT00254540|Secondary|Trough Plasma Concentration (Ctrough) of SU-011248+SU-012662 in Pretreated Population|"SU-012662 is a metabolite of SU-011248. Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration.
The Ctrough for total drug (SU011248+SU012662) was calculated as the mean of the Ctrough of total drug from each individual subject."|Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 plasma concentration data for Pharmacokinetic analysis.
Descriptive statistics on Cycle 2 Day 1 and Cycle 3 Day 28 were not calculated because number of subjects with analyzable data was less than 3.
n=Number of subjects with analyzable data."||ng/mL||Full Range|Median
715448|NCT00254540|Secondary|Trough Plasma Concentration (Ctrough) of SU-012662 in Pretreated Population|SU-012662 is a metabolite of SU-011248. Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration|Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 plasma concentration data for Pharmacokinetic analysis.
Descriptive statistics on Cycle 2 Day 1 and Cycle 3 Day 28 were not calculated because number of subjects with analyzable data was less than 3.
n=Number of subjects with analyzable data."||ng/mL||Full Range|Median
715449|NCT00254540|Secondary|Trough Plasma Concentration (Ctrough) of SU-012662 in First-line Treatment Population|SU-012662 is a metabolite of SU-011248. Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration|Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 plasma concentration data for Pharmacokinetic analysis.
n=Number of subjects with analyzable data."||ng/mL||Full Range|Median
715450|NCT00254540|Secondary|Trough Plasma Concentration (Ctrough) of SU-011248 in Pretreated Population|Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration.|Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 plasma concentration data for Pharmacokinetic analysis.
n=Number of subjects with analyzable data.
Descriptive statistics on Cycle 2 Day 1 and Cycle 3 Day 28 were not calculated because number of subjects with analyzable data was less than 3."||ng/mL||Full Range|Median
715451|NCT00254540|Secondary|Trough Plasma Concentration (Ctrough) of SU-011248 in First-line Treatment Population|Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration|Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 plasma concentration data for Pharmacokinetic analysis.
n=Number of subjects with analyzable data."||ng/mL||Full Range|Median
715452|NCT00254540|Secondary|Change From Baseline of European Quality of Life Questionnaire- 5 Dimensions(EQ-5D) Questionnaires Visual Analog Scale (VAS)|"Change from Baseline: weighted health state VAS score at each observation minus weighted health state VAS score at baseline.
The VAS is a self-completed scale designed to rate the subject’s current health state from 0 to 100 where 0 represents the worst imaginable health state and 100 represents the best imaginable health state."|Day 28 of Cycle 1; Days 1 and 28 of Cycles 2-4|"Intent-to-Treat (ITT) population defined as all subjects enrolled in study that receive at least 1 dose of study medication.
n=Number of subjects with analyzable data."||Scores on a scale||Standard Deviation|Mean
715453|NCT00254540|Secondary|Change From Baseline of European Quality of Life Questionnaire- 5 Dimensions(EQ-5D) Questionnaires Health State Index Score|Change from Baseline: weighted health state index at each observation minus weighted health state index at baseline. The EQ-5D evaluates 5 dimensions of health. The subjects rates the severity of impairment for each dimensions on a 3-point scale (1 to 3). The digits for five dimensions were combined in a five-digit number describing the respondent's health state. Health states were converted into a weighted health state index (Range: 0 to 1). High score is indicating high health.|Day 28 of Cycle 1; Days 1 and 28 of Cycles 2-4|"Intent-to-Treat (ITT) population defined as all subjects enrolled in study that receive at least 1 dose of study medication.
n=Number of subjects with analyzable data."||Scores on a scale||Standard Deviation|Mean
715454|NCT00254540|Secondary|Overall Survival Time|Overall survival time is defined as the time from the date of first dose of study treatment to the date of the death due to any cause. For subjects whose death had not been confirmed, overall survival time was censored on the last date when the subject was known to be alive.|once year. Up to 3 years after the completion of subject registration.|Intent-to-Treat (ITT) population defined as all subjects enrolled in study that receive at least 1 dose of study medication.||Weeks||Full Range|Median
715455|NCT00254540|Secondary|Time to Tumor Response (TTR)|Time to tumor response (TTR) is defined as the period between the day of initial study treatment and the day of initial confirmation of complete response (CR) or partial response (PR). CR = the disappearance of all target lesions. PR = a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Day 28 of Cycle 1-4, Day 28 of even cycles after Cycle 5, and at the end of the study.|Among Intent-To-Treat population, the number of subjects with objective tumor response based on investigator's assessment was 13 and 14 for the First-line treatment and the Pretreated populations, respectively.||Weeks||Full Range|Median
715456|NCT00254540|Secondary|Duration of Response (DR)|Duration of response (DR) is defined as the period between the day of initial confirmation of complete response (CR) or partial response (PR) and the day of initial confirmation of progressive disease (PD) or death of any cause. For subjects who were not confirmed to have PD or death of any cause during the study (including 28 days after the completion of study treatment) or before the initiation of another antitumor therapy, DR was censored on the final confirmation of progression-free condition during the study.|Day 28 of Cycle 1-4, Day 28 of even cycles after Cycle 5, and at the end of the study. Up to 28 days after the last administration of the study drug.|Among Intent-To-Treat population, the number of subjects with objective tumor response based on investigator's assessment was 13 and 14 for the First-line treatment and the Pretreated populations, respectively.||Weeks||Full Range|Median
715457|NCT00254540|Secondary|Time To Tumor Progression (TTP)|Time to tumor progression (TTP) is defined as the time from the date of first dose of study treatment to the date of the first documentation of progressive disease (PD).|Day 28 of Cycle 1-4, Day 28 of even cycles after Cycle 5, and at the end of the study. Up to 28 days after the last administration of the study drug.|Intent-to-Treat (ITT) population defined as all subjects enrolled in study that receive at least 1 dose of study medication.||Weeks||Full Range|Median
715458|NCT00254540|Secondary|Progression-Free Survival (PFS)|Progression-free survival (PFS) is defined as the time from the date of first dose of study treatment to the date of the first documentation of progressive disease (PD) or death.|Day 28 of Cycle 1-4, Day 28 of even cycles after Cycle 5, and at the end of the study. Up to 28 days after the last administration of the study drug.|Intent-to-Treat (ITT) population defined as all subjects enrolled in study that receive at least 1 dose of study medication.||Weeks||Full Range|Median
715545|NCT00248287|Primary|Objective Response Rates (ORR)|To determine the objective response rates (CR + PR). Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.|2 years|Evaluable population||Percentage of Participants||95% Confidence Interval|Number
715459|NCT00254540|Primary|Number of Subjects With Objective Response|Based on Extramural Review Committee's assessment. Number of subjects with objective response is defined as sum of the subjects with confirmed complete response (CR) and partial response (PR) as the best overall response according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses were those that persisted on repeat imaging study ≥4 weeks after initial documentation of response. CR = the disappearance of all target lesions. PR = a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Day 28 of Cycles 1-4|Intent-to-Treat (ITT) population defined as all subjects enrolled in study that receive at least 1 dose of study medication.||participants|||Number
715460|NCT00254566|Secondary|Change From Baseline in Clinical COPD Questionnaire(CCQ)Mental State Score|1 of 3 domains that combined into the CCQ Total score. Items 3 and 4 address mental state. Subject record their experiences during last 24 hrs. 7 pt scale - 0=asymptomatic and 6=extremely; change=mean score at observation minus mean score at baseline|Test of Cure (TOC) Visit (Day 12-19)|Analysis on Full Analysis Set, LOCF-missing values at TOC will be imputed by carrying forward the last post-baseline observation; Domain score is calculated by deriving the simple average of the relevant items, both mental state items must be non-missing to derive a mental state score||Score on Scale||Standard Error|Least Squares Mean
715461|NCT00254566|Secondary|Change From Baseline in Clinical COPD Questionnaire(CCQ)Functional State Score|1 of 3 domains that combined into the CCQ Total score. Items 7,8,9, and 10 address functional state. Subject record their experiences during last 24 hrs. 7 pt scale - 0=asymptomatic and 6=extremely; change=mean score at observation minus mean score at baseline|Test of Cure (TOC) Visit (Day 12-19)|Analysis on Full Analysis Set, LOCF-missing values at the TOC visit will be imputed by carrying forward the last post baseline observation. Domain score is calculated by deriving the simple average of the relevant items, at least 75% of items must be non-missing to derive the domain score||Score on Scale||Standard Error|Least Squares Mean
715462|NCT00254566|Secondary|Change From Baseline in Clinical COPD Questionnaire(CCQ)Symptoms Score|1 of 3 domains that combined into the CCQ Total score. Items 1,2,5,and 6 address symptoms. Subject record their experiences during last 24 hrs. 7 pt scale – 0=asymptomatic and 6=extremely symptomatic; change=mean score at observation minus mean score at baseline|Test of Cure (TOC) Visit (Day 12-19)|Analysis on Full Analysis Set, LOCF - missing values at the TOC visit will be imputed by carrying forward the last post baseline observation. Domain score is calculated by deriving the simple average of the relevant items, at least 75% of items must be non-missing to derive the domain score||Score on Scale||Standard Error|Least Squares Mean
715463|NCT00254566|Secondary|Change From Baseline in Clinical COPD Questionnaire(CCQ)Total Score|CCQ was developed to measure health status of Chronic obstructive pulmonary disease (COPD) subjects. 10 items divided into 3 domains: symtoms, functional state, and mental state. Subject record their experiences during last 24 hrs. 7 pt scale - 0=asymptomatic and 6=extremely symptomatic/totally limited; change=mean score at observation minus mean score at baseline|Test of Cure (TOC) Visit (Day 12-19)|Analysis on Full Analysis Set, Last Observation Carried Forward (LOCF)-missing values at TOC visit will be imputed by carrying forward the last post-baseline observation; total score calculated by deriving the simple average of relevant items, total score is set to missing if 1 or more domain scales cannot be derived.||Score on Scale||Standard Error|Least Squares Mean
715464|NCT00254566|Secondary|Time Taken for First Quartile (25%) of Subjects to Have AECB Recurrence|Subject is considered to have AECB recurrence if they had a clinical response of cure at the TOC visit and then met the definition of AECB during the follow-up period.|Number of Days|Time to AECB recurrence will be analyzed for the FAS using survival analysis methods to account for censored observations. Subjects are censored at the date last known to have not experienced a recurrence. Median time to recurrence will be estimated using the Kaplan-Meier method.||Days|||Number
715465|NCT00254566|Secondary|Percentage of Bacteriologic Response at Test of Cure Visit|Bacteriogical response assessed on per pathogen basis for Bacteriologic Per Protcol (BPP) set at TOC Visit. If no repeat culture, response is presumed from sponsor assessment of clinical response. Eradication =# of pathogens eradicated at TOC/N; Persistence =# of pathogens persistent at TOC/N; N=# of unique pathogens identified at baseline|Test of Cure (TOC) Visit (Day 12-19)|Bacteriologic per protocol set is compromised of subjects from the Clinical Per Protocol set with a baseline bacterial pathogen. The number of participants is the number of unique pathogens identified at baseline.||Percent|||Number
715466|NCT00254566|Secondary|Percentage of Clinical Cure (Success)at Test of Cure Visit(Clinically Eligible Set)|Clinical Response at TOC Visit for clinically Eligible Subjects, Cure=Signs&symptoms(S&S) of infection return to normal baseline level or clin improvement requiring no other antibiotics(AB); Failure=other AB due to S&S of acute infection persisted/worsened,new clinical S&S of acute infection,or clinical/radiological evidence of pneumonia developed during treatment; percent = # of cure or failure/total # of sub|Test of Cure (TOC) Visit (Day 12-19)|Clinically eligible compromised of subjects from FAS with diagnosis of chronic bronchitis, clinical evidence of AECB based on S&S, & a neg chest radiograph for pneumonia based on radiologist opinion||Percent|||Number
715467|NCT00254566|Secondary|Percentage of Clinical Cure (Success) at Test of Cure Visit (Full Analysis Set)|Clinical response (Cure vs Failure) at the TOC visit for the Full Analysis Set (FAS), Cure=Signs&symptoms(S&S) of infection return to normal baseline level or clin improvement requiring no other antibiotics(AB); Failure=other AB due to S&S of acute infection persisted/worsened,new clinical S&S of acute infection,or clinical/radiological evidence of pneumonia developed during treatment; percent = # of cure or failure/total # of sub|Test of Cure (TOC) Visit (Day 12-19)|Full Analysis Set (FAS) is all randomized subjects who received at least 1 dose of study medication.||Percent|||Number
715468|NCT00254566|Primary|Percentage of Clinical Cure (Success) at Test of Cure Visit(Clinical Per Protocol Population)|Cure=Signs&symptoms(S&S) of infection return to normal baseline level or clin improvement requiring no other antibiotics(AB); Failure=other AB due to S&S of acute infection persisted/worsened,new clinical S&S of acute infection,or clinical/radiological evidence of pneumonia developed during treatment; percent = # of cure or failure/total # of sub|Test of Cure (TOC) Visit (Day 12-19)|Clinical Per Protocol-all randomized subjects who were clinically eligible; received at least 80% of study med; no concomitant systemic antibiotics with activity against Acute Exacerbation of Chronic Bronchitis (AECB) pathogens, assessment made in appropriate visit window.||percent|||Number
715469|NCT00254592|Primary|Overall Clinical Response to the Dose Dense Regimen||3 years|||participants|||Number
715470|NCT00254982|Primary|Proportion of Participants Achieving a Greater Than or Equal to 75% Improvement in Psoriasis Area and Severity Index (PASI75) Score|PASI75 response is defined as participants who achieved at least a 75% improvement in PASI score from Baseline to Week 22. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their responses to therapy. The PASI produces a numeric score that can range from 0 to 72 (the higher the number, the worse the disease).|Baseline and Week 22|Per Protocol Population - All participants in the intent to treat population who completed the study without major protocol violations. For missing data, the last observation carried forward (LOCF) was applied.||Proportion of participants|||Number
715471|NCT00254995|Other Pre-specified|Summary of Reported Pregnancy Outcomes in Menactra Vaccine Recipients Pregnant at or Within 28 Days After Vaccination|Only persons who received Menactra vaccine during the study period were included in this outcome.|Day 0 up to Determination of Pregnancy Outcome|Only persons who received Menactra vaccine during the study period were included in the analysis. There were no control group analysis because the threshold of 25 pregnancies with known were not achieved at the time the surveillance was concluded.||Paticipants|||Number
715472|NCT00254995|Other Pre-specified|Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination – Hospital Setting – All Ages Combined|Only persons who received Menactra vaccine during the study period were surveyed and included in this outcome.|Day 0 up to 6 months post-vaccination|Only persons who received Menactra vaccine during the study period were included in the analysis.||Events per 1,000 doses|||Number
715473|NCT00254995|Other Pre-specified|Rates of Serious Adverse Events Per 1000 Doses During 6 Months After Menactra Vaccination – ER Setting – All Ages Combined.|Only persons who received Menactra vaccine during the study period were surveyed and included in this outcome.|Day 0 up to 6 months post-vaccination|Only all persons who received Menactra vaccine during the study period were included in the analysis.||Events per 1,000 doses|||Number
715474|NCT00254995|Other Pre-specified|Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls – By Age Categories – Long-Term Passive Surveillance|Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in the 6-month surveillance period. For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in age-matched controls. Clinical setting is given in parenthesis as either (H) for hospital or (ER) for emergency room.|Day 0 up to Day 180 post-vaccination|All persons who received Menactra vaccine during the study period were included in the analysis.||Events per 1,000 person-months|||Number
715475|NCT00254995|Other Pre-specified|Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls – All Ages Combined – Long-Term Passive Surveillance|Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in the 6-month surveillance period. For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in age-matched controls. Clinical setting is given in parenthesis as either (H) for hospital or (ER) for emergency room.|Day 0 up to Day 180 post-vaccination|All persons who received Menactra vaccine during the study period were included in the analysis.||Events per 1,000 person-months|||Number
715476|NCT00254995|Other Pre-specified|Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls – By Age Categories – Long-Term Passive Surveillance|Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in the 6-month surveillance period. For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in age-matched controls. Clinical setting is given in parenthesis as (C) for pre-specified adverse events, (H) for hospital, (ER) for emergency room.|Day 0 up to Day 180 post-vaccination|All persons who received Menactra vaccine and their age-matched controls during the study period were included in the analysis.||Events per 1,000 person-months|||Number
715477|NCT00254995|Other Pre-specified|Summary of Diagnoses With Significantly Elevated Findings From Risk-Window vs. Control-Window Comparisons – By Age Categories – Short-Term Passive Surveillance|Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months for each 30-day comparison window. Individuals receiving Menactra vaccine served as their own controls for evaluation of acute (Days 0–30) events. Rates of events occurring during Days 0–30 following vaccination were compared to rates of events occurring during Days 31–60 following vaccination. Clinical setting is given in parenthesis as either (H) for hospital or (ER) for emergency room.|Day 0 up to Day 60 post-vaccination|All persons who received Menactra vaccine during the study period were included in the analysis.||Events per 1,000 person-months|||Number
715478|NCT00254995|Other Pre-specified|Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls – All Ages Combined – Long-Term Passive Surveillance|Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in the 6-month surveillance period. For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in age-matched controls. Clinical setting is given in parenthesis as either (H) for hospital or (ER) for emergency room.|Day 0 up to Day 180 post-vaccination|All persons who received Menactra vaccine during the study period were included in the analysis.||Events per 1,000 person-months|||Number
715546|NCT00248495|Secondary|Percent Change in SUV Level Between Pre and Post Chemotherapy|Percent change of PET/SUV levels between baseline and post-chemotherapy.|Baseline and post-chemotherapy|All treated and eligible patients||Percentage change in SUV level||Standard Deviation|Mean
715479|NCT00254995|Primary|Summary of Diagnoses With Significantly Elevated Findings From Risk-Window vs. Control-Window Comparisons: All Ages Combined – Short-Term Passive Surveillance|Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each 30-day comparison window. Individuals receiving Menactra vaccine served as their own controls for evaluation of acute (Days 0–30) events. Rates of events occurring during Days 0–30 following vaccination were compared to rates of events occurring during Days 31–60 following vaccination. Clinical setting is given in parenthesis as either (H) for hospital or (ER) for emergency room.|Day 0 up to Day 60 post-vaccination|All persons who received Menactra vaccine during the study period were included in the analysis.||Events per 1,000 person-months|||Number
715480|NCT00255008|Primary|Number of Subjects Who Achieved a Sustained Virologic Response (SVR)|SVR is defined as negative hepatitis C virus ribonucleic acid (HCV RNA) in serum at 24 weeks after therapy completion. The study was terminated early due to slow enrollment. The primary outcome measure could not be assessed.|24 weeks after completion of either up to 24 or 48 weeks of therapy|The study was terminated early due to slow enrollment. The primary outcome measure should be assessed with caution. No data was available at 24 weeks after therapy for the Genotype 1 Caucasian treatment group.||Participants|||Number
715481|NCT00255034|Primary|Sustained Virological Response (SVR), Defined by Undetectable HCV RNA in Serum at 24 Weeks After Completion of Therapy|No formal comparisons could be made and no conclusions drawn because of small numbers in the treatment groups; a result of an inability to fulfill the recruitment target.|24 weeks after completion of either up to 24 or 48 weeks of therapy|"Data were missing for 1 subject in the 48 weeks of therapy treatment arm."||Participants|||Number
715482|NCT00255047|Primary|Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations.||30 Days post-dose 3 vaccination.|Geometric mean titers were evaluated in the per-protocol immunogenicity population||Titers||95% Confidence Interval|Geometric Mean
715483|NCT00255047|Other Pre-specified|Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3|Solicited injection site reactions: Tenderness, Redness, and Swelling. Solicited systemic reactions: Fever (body temperature), Vomiting, Abnormal crying, Lethargy, Appetite decreased, Irritability, and Rash.|7 days post-vaccination 3|Solicited injection site and systemic reactions were evaluated in the intend-to-treat (ITT) population||Participants|||Number
715484|NCT00255047|Primary|Percentage of Participants With a Four-fold Rise in Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations (Seroconversion)||30 Days post-dose 3 vaccination|Four-fold rise titers (seroconversion) were evaluated in the per-protocol population||Percentage of participants|||Number
715485|NCT00255047|Primary|Percentage of Participant Responding to Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations.|Vaccine response was calculated as a pre-dose 1 titer ≤ Lower Limit of Quantitation (LLOQ) and post-dose 3 titer > LLOQ; or a pre-dose 1 titer > LLOQ and post-dose 3 titer ≥ pre-dose 1 titer.|30 Days post-dose 3 vaccination|The vaccine response to pertussis antigens were determined in the per-protocol population.||Percentage of Participants|||Number
715486|NCT00255086|Secondary|Mean Change on the ADAS-Cog Score After 1 Year|Progression of cognitive functioning as measured by performance on the Alzheimer's Disease (AD) Assessment Scale-cognitive subscale (ADAS-Cog). ADAS-cog is the most popular cognitive testing instrument used in clinical trials of nootropics, and measures disturbances of of memory, language, praxis, attention and other cognitive abilities which are often referred to as the core symptoms of AD. Responses are summed for an overall score which can range from 0-70. The greater the dysfunction, the higher the score. A typical score for a person without dementia is 5.|Baseline; Year 1|Participants who could tolerate study medication and who completed the study were included in the analysis.||units on a scale||Standard Deviation|Mean
715487|NCT00255086|Primary|NAA/Cr Ratio|To determine if memantine has a neuroprotective effect on magnetic resonance spectroscopic imaging (MRS) measures of hippocampal n-acetyl aspartate (NAA) and magnetic resonance imaging volumetric measures (MRI) of hippocampal volume.|Baseline; Year 1|Participants who could tolerate study medication and who completed the study were included in the analysis.||Ratio||Standard Deviation|Mean
715488|NCT00255125|Secondary|Molecular Effects of Soy Supplementation Compared to Placebo.|Using a tissue microarray targeting the cell cycle, selected fresh prostate cancer samples were evaluated in patients in the soy supplement arm compared to the placebo arm.|One year||||||
715489|NCT00255125|Secondary|2.Effect of Soy Isoflavones on Estrogen Receptor Status.|Samples of the prostate cancer tissue (paraffin embedded) were sectioned and placed on a glass slide. Using immunohistochemistry and an estrogen receptor antibody, sections were stained and assess to determine the extent of estrogen receptor expression. Patients in the soy supplement arm's samples results were compared to placebo arm results.|One year||||||
715490|NCT00255125|Primary|1.Effect of Soy Isoflavones on Serum Testosterone Levels.|Total testosterone (ng/ml) serum levels were measured at the time of enrollment(baseline), after two weeks on soy supplement(time point 1), and just prior to prostatectomy (time point 2). All patients must have completed at least two week of soy supplement or placebo and time point 3 varied depending on date of planned prostatectomy. Results were analyzed and are reported at the two week time period, comparing between patients receiving soy supplement or placebo.|Two weeks|||ng/ml||80% Confidence Interval|Mean
715491|NCT00255151|Secondary|Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Mean.|The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.|6 months|The analysis was performed on ITT subjects with at least one nighttime heartburn Yes/No question answered during treatment.||Percentage of Days||Standard Deviation|Mean
715492|NCT00255151|Secondary|Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Median.|The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.|6 months|The analysis was performed on ITT subjects with at least one nighttime heartburn Yes/No question answered during treatment.||Percentage of Days||Inter-Quartile Range|Median
715494|NCT00255151|Secondary|Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Mean.|The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked|6 months|The analysis of 24-hour heartburn-free days was performed on ITT subjects with at least one daytime or nighttime heartburn Yes/No question answered during treatment.||Percentage of Days||Standard Deviation|Mean
715496|NCT00255151|Primary|Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Crude Rate Analysis.|Crude rates analyzed maintenance of healed EE from baseline of this study and considered prematurely discontinued subjects as relapsed.|6 months|The crude rate analysis was performed on intent-to-treat (ITT) subjects (subjects from Studies T-EE04-084 or T-EE04-085 with endoscopically proven healed EE who received at least 1 dose of study drug in this study and did not have a gap of >7 days between the EE healing studies and this study) with at least one endoscopy in this maintenance study.||Percentage of Subjects|||Number
715497|NCT00255164|Secondary|Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Mean.|The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.|6 months|The analysis was performed on ITT subjects with at least one nighttime heartburn Yes/No question answered during treatment.||Percentage of Days||Standard Deviation|Mean
715498|NCT00255164|Secondary|Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Median.|The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.|6 months|The analysis was performed on ITT subjects with at least one nighttime heartburn Yes/No question answered during treatment.||Percentage of Days||Inter-Quartile Range|Median
715499|NCT00255164|Primary|Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Life Table Method|Percentage of subjects who maintained complete healing of erosive esophagitis as assessed by endoscopy. In the life table method, subjects without post-baseline endoscopy were included as censored; subjects who did not have a recurrence of EE and did not complete the study were also considered censored.|6 months|Life table method for the maintenance rate of healed EE was performed on ITT subjects and included subjects without post-baseline endoscopy as censored.||Percentage of Subjects|||Number
715500|NCT00255164|Secondary|Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Mean.|The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked|6 months|The analysis of 24-hour heartburn-free days was performed on ITT subjects with at least one daytime or nighttime heartburn Yes/No question answered during treatment.||Percentage of Days||Standard Deviation|Mean
715501|NCT00255164|Secondary|Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Median.|The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was reported.|6 months|The analysis of 24-hour heartburn-free days was performed on ITT subjects with at least one daytime or nighttime heartburn Yes/No question answered during treatment.||Percentage of Days||Inter-Quartile Range|Median
715502|NCT00255164|Primary|Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Crude Rate Analysis.|Crude rates analyzed maintenance of healed EE from baseline of this study and considered prematurely discontinued subjects as relapsed.|6 months|The crude rate analysis was performed on intent-to-treat (ITT) subjects (subjects from Studies T-EE04-084 or T-EE04-085 with endoscopically proven healed EE who received at least 1 dose of study drug in this study and did not have a gap of >7 days between the EE healing studies and this study) with at least one endoscopy in this maintenance study.||Percentage of Subjects|||Number
715503|NCT00255177|Primary|Mean Log Change in Viral Load From Baseline (Day 1) to Day 28|Mean log change in HCV RNA viral load (significant reduction is considered >0.5 log 10) from baseline (Day 1) following once or twice daily dosing for 28 days at the 28 day timepoint|Baseline (Day 1) to Day 28|||copies/mL on log scale||Standard Deviation|Log Mean
715504|NCT00255190|Primary|Changes From Baseline to Final Visit in Fundus Biopsy Results|Normal=normal tissue; Unknown Baseline = Baseline biopsy not available; Abnormal diagnoses include: Reactive Gastropathy, Chronic Gastritis, Intestinal Metaplasia, Reflective Observation Mucosa-Associated Lymphoid Tissue Lymphoma, Other Abnormal.|Baseline and Final Visit (up to 12 months)|All subjects with Final Visit fundus biopsies are included. Each subject is counted only once per tissue type based on the worst diagnosis. Final Visit was the last visit of this study and no more than 14 days postdosing.||subjects|||Number
715505|NCT00255190|Primary|Changes From Baseline to Final Visit in Antrum Biopsy Results|Normal=normal tissue; Unknown Baseline = Baseline biopsy not available; Abnormal diagnoses include: Reactive Gastropathy, Chronic Gastritis, Intestinal Metaplasia, Reflective Observation Mucosa-Associated Lymphoid Tissue Lymphoma, Other Abnormal.|Baseline and Final Visit (up to 12 months)|All subjects with Final Visit antrum biopsies are included. Each subject is counted only once per tissue type based on the worst diagnosis. Final Visit was the last visit of this study and no more than 14 days post-dosing.||subjects|||Number
715506|NCT00255190|Secondary|Mean Change From Baseline to Month 12 for PAGI-SYM Total Score|Mean overall composite symptom-severity score changes were computed in response to 20 questions, each scored 0 (no symptoms) to 5 (most severe symptoms). Negative changes from baseline indicate improvement in symptoms (decrease in severity).|Baseline and Month 12|All subjects who received at least 1 dose of study drug and had a value for ≥1 subscale at both baseline and after Day 1 were included in the PAGI analyses.||score on a scale||Standard Deviation|Mean
715507|NCT00255190|Secondary|Mean Change From Baseline to Month 9 for PAGI-SYM Total Score|Mean overall composite symptom-severity score changes were computed in response to 20 questions, each scored 0 (no symptoms) to 5 (most severe symptoms). Negative changes from baseline indicate improvement in symptoms (decrease in severity).|Baseline and Month 9|All subjects who received at least 1 dose of study drug and had a value for ≥1 subscale at both baseline and after Day 1 were included in the PAGI analyses.||score on a scale||Standard Deviation|Mean
715508|NCT00255190|Secondary|Mean Change From Baseline to Month 6 for PAGI-SYM Total Score|Mean overall composite symptom-severity score changes were computed in response to 20 questions, each scored 0 (no symptoms) to 5 (most severe symptoms). Negative changes from baseline indicate improvement in symptoms (decrease in severity).|Baseline and Month 6|All subjects who received at least 1 dose of study drug and had a value for ≥1 subscale at both baseline and after Day 1 were included in the PAGI analyses.||score on a scale||Standard Deviation|Mean
715526|NCT00255190|Primary|Mean Change From Baseline to Month 12 for White Blood Cell Count Values||Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.||White Blood Cell count x10 to the 3/mcL||Standard Deviation|Mean
715509|NCT00255190|Secondary|Mean Change From Baseline to Month 3 for PAGI-SYM Total Score|Mean overall composite symptom-severity score changes were computed in response to 20 questions, each scored 0 (no symptoms) to 5 (most severe symptoms). Negative changes from baseline indicate improvement in symptoms (decrease in severity).|Baseline and Month 3|All subjects who received at least 1 dose of study drug and had a value for ≥1 subscale at both baseline and after Day 1 were included in the PAGI analyses.||score on a scale||Standard Deviation|Mean
715510|NCT00255190|Secondary|Mean Change From Baseline to Month 1 for PAGI-SYM Total Score|Mean overall composite symptom-severity score changes were computed in response to 20 questions, each scored 0 (no symptoms) to 5 (most severe symptoms). Negative changes from baseline indicate improvement in symptoms (decrease in severity).|Baseline and Month 1|All subjects who received at least 1 dose of study drug and had a value for ≥1 subscale at both baseline and after Day 1 were included in the PAGI analyses.||score on a scale||Standard Deviation|Mean
715511|NCT00255190|Secondary|Mean Change From Baseline to Month 12 for PAGI-QOL Total Score|Mean overall composite QOL score changes were computed in response to 30 questions, each scored 0 (lowest QOL) to 5 (highest QOL). Positive changes from baseline indicate improved QOL.|Baseline and Month 12|All subjects who received at least 1 dose of study drug and had a value for ≥1 subscale at both baseline and after Day 1 were included in the PAGI analyses.||score on a scale||Standard Deviation|Mean
715512|NCT00255190|Secondary|Mean Change From Baseline to Month 9 for PAGI-QOL Total Score|Mean overall composite QOL score changes were computed in response to 30 questions, each scored 0 (lowest QOL) to 5 (highest QOL). Positive changes from baseline indicate improved QOL.|Baseline and Month 9|All subjects who received at least 1 dose of study drug and had a value for ≥1 subscale at both baseline and after Day 1 were included in the PAGI analyses.||score on a scale||Standard Deviation|Mean
715513|NCT00255190|Secondary|Mean Change From Baseline to Month 6 for PAGI-QOL Total Score|Mean overall composite QOL score changes were computed in response to 30 questions, each scored 0 (lowest QOL) to 5 (highest QOL). Positive changes from baseline indicate improved QOL.|Baseline and Month 6|All subjects who received at least 1 dose of study drug and had a value for ≥1 subscale at both baseline and after Day 1 were included in the PAGI analyses.||score on a scale||Standard Deviation|Mean
715514|NCT00255190|Primary|Mean Change From Baseline to Month 12 for Pulse Rate||Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.||beats per minute||Standard Deviation|Mean
715515|NCT00255190|Primary|Mean Change From Baseline to Month 12 for Diastolic Blood Pressure||Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.||mm Hg||Standard Deviation|Mean
715516|NCT00255190|Primary|Mean Change From Baseline to Month 12 for Systolic Blood Pressure||Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.||mm Hg||Standard Deviation|Mean
715517|NCT00255190|Primary|Mean Change From Baseline to Month 12 for Serum Gastrin Levels||Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.||pg/mL||Standard Deviation|Mean
715518|NCT00255190|Primary|Mean Change From Baseline to Month 12 for Alanine Aminotransferase Values||Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.||U/L||Standard Deviation|Mean
715519|NCT00255190|Primary|Mean Change From Baseline to Month 12 for Aspartate Aminotransferase Values||Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.||U/L||Standard Deviation|Mean
715520|NCT00255190|Primary|Mean Change From Baseline to Month 12 for Alkaline Phosphatase Values||Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.||U/L||Standard Deviation|Mean
715521|NCT00255190|Primary|Mean Change From Baseline to Month 12 for Total Bilirubin Values||Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.||mg/dL||Standard Deviation|Mean
715522|NCT00255190|Primary|Mean Change From Baseline to Month 12 for Inorganic Phosphorus Values||Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.||mg/dL||Standard Deviation|Mean
715523|NCT00255190|Primary|Mean Change From Baseline to Month 12 for Calcium Values||Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.||mg/dL||Standard Deviation|Mean
715524|NCT00255190|Primary|Mean Change From Baseline to Month 12 for Creatinine Values||Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.||mg/dL||Standard Deviation|Mean
715525|NCT00255190|Primary|Mean Change From Baseline to Month 12 for Blood Urea Nitrogen Values||Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.||mg/dL||Standard Deviation|Mean
715547|NCT00248495|Secondary|Correlation Between Response and Markers Such as Presence or Absence of ERCC1 and DHFR, TS, DPD and GARFT||1 year|No participants were analyzed as there was no budget left to do the analysis.|||||
715528|NCT00255190|Primary|Mean Change From Baseline to Month 12 for Mean Corpuscular Hemoglobin Concentration Values||Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.||g/dL||Standard Deviation|Mean
715529|NCT00255190|Primary|Mean Change From Baseline to Month 12 for Red Blood Cell Count Values||Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.||Red Blood Cell count x10 to the 6/μL||Standard Deviation|Mean
715530|NCT00255190|Secondary|Mean Change From Baseline to Month 3 for PAGI-QOL Total Score|Mean overall composite QOL score changes were computed in response to 30 questions, each scored 0 (lowest QOL) to 5 (highest QOL). Positive changes from baseline indicate improved QOL.|Baseline and Month 3|All subjects who received at least 1 dose of study drug and had a value for ≥1 subscale at both baseline and after Day 1 were included in the PAGI analyses.||score on a scale||Standard Deviation|Mean
715531|NCT00255190|Secondary|Mean Change From Baseline to Month 1 for PAGI-QOL Total Score|Mean overall composite Quality of Life (QOL) score changes were computed in response to 30 questions, each scored 0 (lowest QOL) to 5 (highest QOL). Positive changes from baseline indicate improved QOL.|Baseline and Month 1|All subjects who received at least 1 dose of study drug and had a value for ≥1 subscale at both baseline and after Day 1 were included in the Patient Assessment of Upper Gastrointestinal Disorders (PAGI) analyses.||score on a scale||Standard Deviation|Mean
715532|NCT00255190|Primary|Mean Change From Baseline to Month 12 for Hematocrit Values|Hematocrit measurement percent is the absolute difference in Hematocrit values, and not percentage difference.|Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.||percentage||Standard Deviation|Mean
715533|NCT00255190|Primary|Mean Change From Baseline to Month 12 for Hemoglobin Values||Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.||g/dL||Standard Deviation|Mean
715534|NCT00248170|Secondary|Percentage of Participants Who Experienced Cardiovascular Events|The incidence of ischemic heart disease, cardiac failures, cerebrovascular accidents and thromboembolic events was analyzed.|84 months|Safety Set: The safety set included randomized participants who received at least one of study medication and had at least one post baseline assessment.||Percentage of participants|||Number
715535|NCT00248170|Secondary|Percentage of Participants Who Experienced Clinical Fracture Events|The incidence of clinical fractures was analyzed.|84 months|Safety Set: The safety set included randomized participants who received at least one of study medication and had at least one post baseline assessment.||Percentage of participants|||Number
715536|NCT00248170|Secondary|Change From Baseline in Serum Lipid Profiles|Total cholesterol was analyzed to assess the impact on serum lipids profiles. The adjusted means was calculated.|baseline, 6, 12, 24, 36, 48 and 60 months|Safety Set: The safety set included randomized participants who received at least one of study medication and had at least one post baseline assessment.||mg/dL||95% Confidence Interval|Mean
715537|NCT00248170|Secondary|Distant Disease-free Survival|Distant disease-free survival was defined as the time from date of randomization to the date of the first development of any relapse at a distant site or death from any cause.|84 months|Intent-to-treat (ITT) - the ITT contained randomized participants who had no protocol deviations.||Months||95% Confidence Interval|Median
715538|NCT00248170|Secondary|Time to Development of Contra Lateral Breast Cancer|Time to development of contra lateral breast cancer was defined as the time from the date of randomization to the date of the first development of any disease in the contra lateral breast.|84 months|Intent-to-treat (ITT) - the ITT contained randomized participants who had no protocol deviations.||Months||95% Confidence Interval|Median
715539|NCT00248170|Secondary|Time to Development of Distant Metastases|Time to development of distant metastases was defined as the time from date of randomization to the date of the first development of any recurrent or metastatic disease in sites other than the local mastectomy scar, the ipsilateral breast in case of breast conservation or the contra lateral breast.|84 months|Intent-to-treat (ITT) - the ITT contained randomized participants who had no protocol deviations.||Months||95% Confidence Interval|Median
715540|NCT00248170|Secondary|Overall Survival|Overall survival was defined as the time from the date of randomization to the date of death from any cause.|84 months|Intent-to-treat (ITT) - the ITT contained randomized participants who had no protocol deviations.||Months||95% Confidence Interval|Median
715541|NCT00248170|Primary|Disease Free Survival|Disease-free survival was defined as the time from the date of randomization to the date of the first documentation of re-occurrence of invasive breast cancer in local, regional or distant sites, new invasive breast cancer in the contra-lateral breast, or death from any cause.|84 months|Intent-to-treat (ITT) - the ITT contained randomized participants who had no protocol deviations.||Months||95% Confidence Interval|Median
715542|NCT00248287|Secondary|Median Overall Survival (OS)|OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.|2 years|ITT population||months||95% Confidence Interval|Median
715543|NCT00248287|Secondary|Median Time of Progression-free Survival (PFS)|PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date.|2 years|ITT population||months||95% Confidence Interval|Median
715544|NCT00248287|Secondary|Duration of Response|"The duration of response is measured from the time measurement criteria are first met for CR/PR until the first date that recurrent or progressive disease is objectively documented.
Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD."|From date of randomization until the date of first documented progression or the date of death from any cause, whichever came first, assessed up to 60 months.|For patients who achieve a major objective response (CR or PR) the time to response will be assessed as the date of registration to the date of response.||months||Full Range|Median
715548|NCT00248495|Secondary|Disease Free Survival|Progressive disease is defined as at least a 20% increase in the sum of the longest diameter of target lesions or the appearance of new lesions. Disease Free Survival was defined as time from date of treatment initiation until date of first documented progression or date of death from any cause, whichever came first.|At least every 3 months after the completion of adjuvant therapy for two years and thereafter every 6 months for 3 years and then yearly up to 126 months|All treated and eligible patients||months||95% Confidence Interval|Median
715549|NCT00248495|Secondary|Overall Survival|Overall survival was defined as time from date of treatment initiation until date of death due to any cause.|Every 6 months until the time of death up to 126 months|All treated and eligible patients||months||95% Confidence Interval|Median
715550|NCT00248495|Secondary|Number of Participants With Adverse Events|Frequency of Adverse Events, Graded According to NCI CTCAE v3.0. Please refer to the adverse event reporting for more detail.|1 year|All treated and eligible patients||Participants|||Count of Participants
715551|NCT00248495|Primary|Pathologically Complete Response|Pathologic Complete Response is defined by a surgical pathology specimen, which is free of all gross and microscopic evidence of viable tumor.|1 year|ll treated and eligible patients||percentage of participants||95% Confidence Interval|Number
715552|NCT00248547|Secondary|Pharmacokinetic Interaction|To assess the potential for aprepitant and cyclophosphamide to interact pharmacokinetically in a significant manner to change blood levels of aprepitant, cyclophosphamide, hydroxycyclophosphamide or CEPM.|Up to three weeks||||||
715553|NCT00248547|Secondary|Effects on Nausea, Appetite and Taste Changes|To assess the effects of aprepitant on nausea, appetite, and taste changes, (via visual analogue scale [VAS]), nutritional intake, and mucositis in the bone marrow transplant population.|Up to three weeks||||||
715554|NCT00248547|Secondary|Safety in Transplant Population|To assess the safety of aprepitant in the bone marrow transplant population|Up to three weeks||||||
715555|NCT00248547|Primary|Number of Emesis Free Participants During the Study Period.|To compare the efficacy of aprepitant plus standard therapy to placebo plus standard therapy in control of nausea and vomiting during conditioning therapy for autologous or allogeneic hematopoietic stem cell transplantation (HSCT) as defined by the number of retch/emesis free days during the study period|Up to three weeks|||Participants|||Number
715556|NCT00248560|Secondary|Toxicity as Measured by Number and Grade of Adverse Events||Every 2 weeks||||||
715557|NCT00248560|Secondary|Survival||Every 8 weeks||||||
715558|NCT00248560|Secondary|Response Duration||Every 8 weeks||||||
715559|NCT00248560|Primary|Response (Complete Response [CR] + Partial Response [PR])|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|every 8 weeks until off study|||participants|||Number
715560|NCT00248612|Secondary|HAM-D Scale|HAM-D (Hamilton Rating Scale for Depression) is a multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery. The scoring is based on 17 items. Eight of the items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine items are scored on a 3 point scale from 0-2 where 0=none or absent and 2= severe. The total scores for the HAM-D can range from 0 to 50. The total scores are interpreted as: 0-7=normal, 8-13=mild, 14-18= moderate, 19-22= severe, and 23+=very severe depression. The higher the score the more severe the participant's depression.|Session 1 (baseline), Session 8 (8 weeks of treatment)|||units on a scale||Standard Deviation|Least Squares Mean
715561|NCT00248612|Secondary|HAM-A Scale|The Hamilton Anxiety Rating Scale (HAM-A) is a psychological questionnaire used by clinicians to rate the severity of a patient's anxiety. The HAM-A probes 14 parameters each item is scored on a 5-point scale, ranging from 0=not present to 4=severe. total scores can range from 0 to 56.where <17 indicates mild anxiety, 18–24 moderate anxiety and 25–30 severe anxiety. Higher scores reflect more anxiety.|Session 1 (baseline), Session 8 (8 weeks of treatment)|||units on a scale||Standard Deviation|Least Squares Mean
715562|NCT00248612|Secondary|DASS Stress Subscale Score|DASS (Depression Anxiety Stress Scales) assesses depression, anxiety and stress responses. Each of the three DASS scales contains 14 items, divided into subscales of 2-5 items with similar content. The stress subscale was used which assesses difficulty relaxing, nervous arousal, and being easily upset/agitated, irritable/over-reactive and impatient. Subjects are asked to use 4-point severity/frequency scales to rate the extent to which they have experienced each state over the past week. Stress scores can range form 0-56 with 0-14=normal, 15-18=mild, 19-25=moderate, 26-33=severe. and 34+=extremely severe stress.|Session 1 (baseline), Session 11 (11 weeks of treatment)|||units on a scale||Standard Deviation|Least Squares Mean
715563|NCT00248612|Secondary|Medication Compliance Rates|The medication compliance rate is the percentage of participants in each study arm who took their medication based on pill counts.|12 months|||percentage of participants|||Number
715564|NCT00248612|Secondary|Treatment Completion|The number and percent of participants that completed the treatment in each arm of the study.|12 months|||Participants|||Count of Participants
715565|NCT00248612|Primary|Number of Participants Abstinent|Abstaining from the consumption of intoxicating beverages.|Session 8 (8 weeks of treatment)|||Participants|||Count of Participants
715566|NCT00248612|Primary|Craving Desire Scale (CDS)|"The Craving Desire Scale (CDS) is a 3-item scale (1. I do want to drink now”, “2. I crave a drink right now”, 3. “I have a desire for a drink right now”) used to identify the degree of current alcohol craving, with responses provided on a Likert scale of 1-7: with 1 meaning strongly disagree, and 7 meaning strongly agree to each of the 3 items. Total scores can range from 3 to 21 with higher scores indicating greater craving for alcohol."|1 (Baseline) , Session 8 (8 weeks of treatment), Session 11 (11 weeks of treatment)|||units on a scale||Standard Deviation|Mean
715567|NCT00248612|Primary|Clinical Global Impression Scale-S (CGI-S)|"Global severity of alcohol dependence: Considering your total clinical experience with the alcohol dependent population how severe are his/her alcohol dependence symptoms at this time?
(1-Normal, no symptoms, 2-Borderline symptoms, 3-Mild symptoms, 4-Moderate symptoms, 5-Marked symptoms, 6-Severe symptoms, 7-Among the most extreme symptoms)"|1 (Baseline) , Session 8 (8 weeks of treatment), Session 11 (11 weeks of treatment)|||units on a scale||Standard Deviation|Mean
715593|NCT00248781|Secondary|Knee Extension Strength (Durability)|The peak force measured during the bilateral knee extension exercise against the highest level of a hydraulic resistance system|12 months|||kg||Standard Deviation|Mean
715568|NCT00248612|Primary|Clinical Global Impression Scale-I (CGI-I)|"Global improvement of alcohol dependence: Rate the total improvement in the participant’s alcohol dependence symptoms whether or not, in your judgment, it is due entirely to treatment. Compared to his/her admission to the project, how much has s/he changed?
(1-Not assessed, first rating, 2-Very much improved, 3-Much improved, 4-Minimally improved, 5-Unchanged, 6-Minimally worse, 7-Much worse, 8-Very much worse)"|Session 1 (Baseline) , Session 8 (8 weeks of treatment), Session 11 (11 weeks of treatment)|||units on a scale||Standard Deviation|Mean
715569|NCT00248625|Secondary|Infectious Complication||Within 7 days of randomization|||Participants|||Number
715570|NCT00248625|Secondary|Highest Coma Grade of Hepatic Encephalopathy|West Haven Criteria for hepatic encephalopathy (Grade 0 - IV ) is used for participants > 3 year of age. Coma grade IV indicates a participant who is comatose , with no reflexes, is decerebrate and has abnormal EEG changes with very slow delta activity. For participants less than 3 years the Whittington Scale was used. The Whittington scale does not use EEG changes and has only 3 levels, early (grades I and II), Mid (III) with somnolence, stupor, combativeness and Late (IV) for participants who are comatose with absent reflexes and decerebrate or decorticate posturing.|Within 7 days of randomization|All enrolled participants where coma grade could be assessed. Four participants (two in each randomization arm) could not have coma grade assessed during the 7 days after randomization.||participants|||Number
715571|NCT00248625|Secondary|Number of Organ Systems Failing||Within 7 days of randomization|||participants|||Number
715572|NCT00248625|Secondary|Categorized Length of ICU Stay|The length of ICU stay was categorized as number of days in ICU within 7 days of randomization, unless participant either died or received an LTx within this time period. Special categories were created for these cases.|Within 7 days of randomization|||participants|||Number
715573|NCT00248625|Secondary|Length of Hospital Stay||Randomization to hospital discharge|All participants enrolled in study with hospital stay information, 2 participants (1 in each arm) did not have hospital discharge information.||days||Inter-Quartile Range|Median
715574|NCT00248625|Secondary|Cumulative Percent Incidence of Transplantation by 1 Year||Within 1 year of randomization|||percentage of participants|||Number
715575|NCT00248625|Secondary|Spontaneous Recovery|Survival without liver transplantation|One year following randomization|All participants enrolled in study||participants|||Number
715576|NCT00248625|Primary|Survival|Spontaneous survival without transplant plus survival following transplantation|One year following randomization|All participants who were enrolled in the study were included in the survival analysis||Participants|||Number
715577|NCT00248638|Secondary|Heat Shock Proteins Levels||28 days||||||
715578|NCT00248638|Secondary|Gluthatione Levels||28 days||||||
715579|NCT00248638|Primary|Percent of Patients Who do Not Develop Hospital Infections After Entry|Subjects remaining infection-free during the hospitalization.|While the patient is admitted during the current hospitalization up to 6 months|||percentage of participants|||Number
715580|NCT00248638|Primary|Hospital Mortality|Mortality during the current hospitalization|Mortality during the current hospitalization up to 6 months|||participants|||Number
715581|NCT00248651|Secondary|Dyspepsia-Specific Quality of Life|The Nepean Dyspepsia Index (NDI) assessed quality of life. NDI scores are summarized into overall quality of life and 5 subscales: Interference, Knowledge/Control, Eating/Drinking, Sleep Disturbance, Work/Study. The scale consists of 25 items, yielding 5 sub-scales. Range 0-100, higher numbers indicate a greater quality of life.|12 Weeks|The intent-to-treat analysis included all randomized subjects.||units on a scale||95% Confidence Interval|Mean
715582|NCT00248651|Secondary|Maximum Tolerated Volume by Nutrient Drink Test|The nutrient drink test for meal-induced satiety had subjects drink 120 ml of ENSURE every four minutes. Satiety scores were measured on a scale graded 0-5 (1, no symptoms; 5, maximum satiety). When a score of 5 was reached, the maximum tolerated volume intake was measured. Abnormal satiety was defined as inability to consume > 800 ml of Ensure.|12 weeks|The intent-to-treat analysis included all randomized subjects.||ml||Standard Deviation|Mean
715583|NCT00248651|Secondary|Gastric Emptying Half-Time (T1/2)|The time for half of the ingested solids or liquids to leave the stomach.|12 weeks|The intent-to-treat analysis included all randomized subjects.||minutes||Standard Deviation|Mean
715584|NCT00248651|Primary|Self-Report of Adequate Relief of Dyspepsia (Yes/No) For at Least 50% of Weeks 3 -12 of Treatment|The first two weeks of treatment were excluded to allow for establishment of steady state drug levels.|3 weeks through 12 weeks|The intent-to-treat analysis included all randomized subjects.||percentage of participants|||Number
715585|NCT00248781|Secondary|Six-minute Walk (Durability)|Total distance walked during 6 minutes. Subjects were instructed to walk up and down a 100-foot level hallway as far as they could in 6 minutes.|12 months|||m||Standard Deviation|Mean
715586|NCT00248781|Secondary|Tandem Stance (Durability)|Length of time standing with the heel of one foot touching the toe of the other foot keeping the feet in a straight line.|12 months|||s||Standard Deviation|Mean
715587|NCT00248781|Secondary|Single Leg Stance With Eyes Open (Durability)|Length of time standing on one leg without moving the support foot, touching the floor or support leg with suspended foot, or requiring assistance.|12 months|||s||Standard Deviation|Mean
715588|NCT00248781|Secondary|Knee Flexion Strength (Durability)|The peak force measured during the bilateral knee flexion exercise against the highest level of a hydraulic resistance system|12 months|||kg||Standard Deviation|Mean
715589|NCT00248781|Primary|Six-minute Walk|Total distance walked during 6 minutes. Subjects were instructed to walk up and down a 100-foot level hallway as far as they could in 6 minutes.|6 months|The number of subjects completing 6 month evaluations||m||Standard Deviation|Mean
715590|NCT00248781|Primary|Tandem Stance|Length of time standing with the heel of one foot touching the toe of the other foot keeping the feet in a straight line.|6 months|The number of subjects completing 6 month evaluations||s||Standard Deviation|Mean
715591|NCT00248781|Primary|Single Leg Stance With Eyes Open|Length of time standing on one leg without moving the support foot, touching the floor or support leg with suspended foot, or requiring assistance.|6 months|The number of subjects completing 6 month evaluations||s||Standard Deviation|Mean
715592|NCT00248781|Primary|Knee Flexion Strength|The peak force measured during the bilateral knee flexion exercise against the highest level of a hydraulic resistance system|6 months|Number of subjects completing 6 month evaluations||kg||Standard Deviation|Mean
715595|NCT00248794|Primary|Independent Living Skills Survey|"Independent Living Skills Survey is a 103 items that assess 12 areas of skills; personal hygiene (6 items), appearance and care of clothing (12 items), care of personal possessions and living space (9 items), food preparation (9 items), care of one's own health and safety (10 items), money management (10 items), transportation (7 items), leisure and recreational activities (13 items), job seeking (6 items), job maintenance (3 items), eating behaviors (9 items), and social interactions (9 items). The items describe relatively specific skills such as washes hair twice a week, and informants indicate how frequently an individual has performed each skill within the past month. The responses are yes (1 point) no (0 points). Scores reports are the average #of yes items/number of total items. Higher scores indicating better functioning."|16 weeks after intake|||units on a scale||Standard Error|Mean
715596|NCT00248794|Primary|Hopkins Verbal Learning Test- Total Recall Variable|This is measure of verbal learning and memory for immediate recall. Respondents are read a list of 12 items and asked to repeat once the last item is given. The list if given 3 times. Each time all items are recorded giving a total score ranging from 0 to 36. The score is converted to T-scores (mean of 50 and sd of 10) using the norms in the manual. The data reported are that in T-Scores with higher scores indicating better functioning.|16 weeks post intake assessment|||units on a scale (T-scores)||Standard Deviation|Mean
715597|NCT00248794|Primary|Continuous Performance Task X/A Version|CPT relative X/A Percentage. This is a task-oriented computerized assessment of attention-related problems. This variable measures the relative sustained attention, and vigilance over the time of the task. Raw performance is standardize using available age and education norms yielding a Standardized Score with a mean of 100. Maximum Standard score is 145 and the minimum is 55 with higher scores reflect better performance.|16 weeks after intake assessment|||units on a scale (standardized units)||Standard Deviation|Mean
715598|NCT00248794|Primary|Bell Lysaker Emotion Recognition Test|21 Item audio-visual task that measures the ability to recognize affective states in others. Affective states presented include: Happiness, Sadness, Surprise, Disgust, Fear, Anger and No Emotion. The instrument is scored for total correct responses with scores ranging from 0 to 21 with higher scores indicate better overall performance.|16 weeks from intake|Two way ANOVA using baseline and completion of intervention data||total correct||Standard Deviation|Mean
715599|NCT00248794|Primary|Wisconsin Card Sort Percent Perseverative Errors (Standard Score)|"This is a measure of cognitive flexibility and the ability to shift set in the face of a changing reinforcement. The measure reflects density of perseverative errors in relation to the overall test performance. It is computed by calculating the ration of perseverative errors to trials administered and multiplied by 100. Then the percentage score is translate using the available Standard Score Tables provided in the manual and converted to a standard score with a mean of 100, a maximum of 145 and a minimum of 55, with higher Standard Scores indicating better performance."|16 weeks after intake|||standard score units||Standard Deviation|Mean
715600|NCT00248807|Secondary|Cerebral Blood Flow|Measurement of middle cerebral artery blood flow velocity supine and during head-up tilt|acute testing|||cm/sec||Standard Deviation|Mean
715601|NCT00248807|Primary|Systolic Blood Pressure|Systolic blood pressure during head-up tilt in subjects with spinal cord injury without drug intervention|acute testing|convenience sample||mmHg||Standard Deviation|Mean
715602|NCT00249002|Primary|Stenosis (%) of a Non-index Lesion Using Angiography at Month 12|Non-indexed lesion with a residual stenosis of less than 30% after the pre-dose angioplasty. The percent of stenosis (narrowing) of the non-index lesion is measured by angiography. Three non-index lesions are reported: central vein, intragraft and arterial anastomosis.|12 months|Treated population of participants with a non-index lesion.||percentage of stenosis|||Number
715603|NCT00249002|Primary|Stenosis (%) of a Non-index Lesion Using Angiography at Month 9|Non-indexed lesion with a residual stenosis of less than 30% after the pre-dose angioplasty. The percent of stenosis (narrowing) of the non-index lesion is measured by angiography. Three non-index lesions are reported: central vein, intragraft and arterial anastomosis.|9 months|Treated population of participants with a non-index lesion.||percentage of stenosis||Standard Deviation|Mean
715604|NCT00249002|Primary|Stenosis (%) of a Non-index Lesion Using Angiography at Week 24|Non-indexed lesion with a residual stenosis of less than 30% after the pre-dose angioplasty. The percent of stenosis (narrowing) of the non-index lesion is measured by angiography. Three non-index lesions are reported: central vein, intragraft and arterial anastomosis.|24 weeks|Treated population of participants with a non-index lesion.||percentage of stenosis||Standard Deviation|Mean
715605|NCT00249002|Primary|Stenosis (%) of a Non-index Lesion Using Angiography at Week 12|Non-indexed lesion with a residual stenosis of less than 30% after the pre-dose angioplasty. The percent of stenosis (narrowing) of the non-index lesion is measured by angiography. Three non-index lesions are reported: central vein, intragraft and arterial anastomosis.|12 weeks|Treated population of participants with a non-index lesion.||percentage of stenosis||Standard Deviation|Mean
715606|NCT00249002|Primary|Stenosis (%) of the Index Lesion at Venous Anastomosis Using Angiography at Month 12|Indexed lesion must be located in the arm and is a polytetrafluoroethylene (PTFE) thrombosed graft or a patent but dysfunctional PTFE graft with a residual stenosis of less than 30% after the pre-dose angioplasty. The percent of stenosis (narrowing) of the index lesion is measured by angiography.|12 months|Treated population of participants with an index lesion at this site.||percentage of stenosis|||Number
715607|NCT00249002|Primary|Stenosis (%) of the Index Lesion at Venous Anastomosis Using Angiography at Month 9|Indexed lesion must be located in the arm and is a polytetrafluoroethylene (PTFE) thrombosed graft or a patent but dysfunctional PTFE graft with a residual stenosis of less than 30% after the pre-dose angioplasty. The percent of stenosis (narrowing) of the index lesion is measured by angiography.|9 months|Treated population of participants with an index lesion at this site.||percentage of stenosis||Standard Deviation|Mean
715608|NCT00249002|Secondary|Percentage of Participants With Patency of Index and Non-Index Lesions at 24 Weeks|The patency (unblocking) for index lesions is defined as <50% of stenosis and no PFTE graft thrombosis at 24 weeks. The patency for non-index lesions is defined as <50% of stenosis and no new non-index lesions at 24 weeks.|24 weeks|Treated Population of evaluable participants||percentage of participants|||Number
715631|NCT00249379|Secondary|Retention in Drug Court|Number of participants remaining in drug treatment court program during 12 weeks|12 weeks|"Only 13 Acamprosate participants were analyzed because one participant was lost to follow-up after being given an initial supply of medication for the study.
No data were collected for the Control Arm because funding ran out for the study."||participants|||Number
715609|NCT00249002|Secondary|Kaplan Meier Estimates for Time to Graft Failure or Intervention|The time to graft failure or intervention was defined as the time from first dose of study drug to the first time graft failure or intervention. Participants who did not have graft failure or intervention at the end of the study were censored at the last known time that the participant had angiography.|up to 12 months|Treated population||weeks||95% Confidence Interval|Median
715610|NCT00249002|Secondary|Participants With Arthrosclerotic Cardiovascular Complications|Counts of participants who had treatment-emergent arthrosclerotic cardiovascular complications, specifically myocardial infarction, arterial thromboses, or cerebrovascular events.|up to week 25|Treated population||participants|||Number
715611|NCT00249002|Primary|Stenosis (%) of the Index Lesion at Venous Anastomosis Using Angiography at Week 24|Indexed lesion must be located in the arm and is a polytetrafluoroethylene (PTFE) thrombosed graft or a patent but dysfunctional PTFE graft with a residual stenosis of less than 30% after the pre-dose angioplasty. The percent of stenosis (narrowing) of the index lesion is measured by angiography.|24 weeks|Treated population of participants with an index lesion at this site.||percentage of stenosis||Standard Deviation|Mean
715612|NCT00249002|Primary|Stenosis (%) of the Index Lesion at Venous Anastomosis Using Angiography at Week 12|Indexed lesion must be located in the arm and is a polytetrafluoroethylene (PTFE) thrombosed graft or a patent but dysfunctional PTFE graft with a residual stenosis of less than 30% after the pre-dose angioplasty. The percent of stenosis (narrowing) of the index lesion is measured by angiography.|12 weeks|Treated population of participants with an index lesion at this site.||percentage of stenosis||Standard Deviation|Mean
715613|NCT00249002|Primary|Percentage of Participants Without Graft Failure or Need for Intervention|Graft failure is defined as graft thrombosis, loss of vascular access function, or >50% stenosis of the index lesion at the time of a regularly scheduled angiographic assessment.|24 weeks|Evaluable participants who were treated||percentage of participants|||Number
715614|NCT00249002|Primary|Percentage of Participants With Discontinued, Delayed or Interrupted Therapy|Percentage of participants who had discontinued therapy or had a delayed dose or an interrupted (omitted) dose due to toxicities/adverse events.|up to week 21|Treated population||percentage of participants|||Number
715615|NCT00249249|Secondary|National Cholesterol Education Program [NCEP]LDL-C Target Attainment|Number of patients achieving NCEP LDL-C target (LDL-C less than or equal to 130 mg/dL)|up to 12 weeks|All patients, irrespective of protocol violations, who had Week 12 measurements, whether on drug or not.||Patients|||Number
715616|NCT00249249|Secondary|Oxidized LDL at 12 Weeks|oxidized low density lipoprotein at 12 weeks|12 weeks|All patients, irrespective of protocol violations, who had Week 12 measurements, whether on drug or not.||U/L||Standard Deviation|Mean
715617|NCT00249249|Secondary|High Sensitivity C-reactive Protein (Hs-CRP) at 12 Weeks|high sensitivity C-reactive protein (hs-CRP) at 12 weeks|12 weeks|All patients, irrespective of protocol violations, who had Week 12 measurements, whether on drug or not.||mg/L||Standard Deviation|Mean
715618|NCT00249249|Secondary|Apo-B:Apo-A1 Ratio|Ratio of Apo-B to Apo-A1 at 12 weeks|12 weeks|All patients, irrespective of protocol violations, who had Week 12 measurements, whether on drug or not.||ratio||Standard Deviation|Mean
715619|NCT00249249|Secondary|Apolipoprotein-A1 (Apo-A1)|Apolipoprotein-A1 at 12 weeks|12 weeks|All patients, irrespective of protocol violations, who had Week 12 measurements, whether on drug or not.||mg/dL||Standard Deviation|Mean
715620|NCT00249249|Secondary|Apolipoprotein B (Apo B)|Apolipoprotein B at 12 weeks|12 weeks|All patients, irrespective of protocol violations, who had Week 12 measurements, whether on drug or not.||mg/dL||Standard Deviation|Mean
715621|NCT00249249|Secondary|Non-HDL:HDL Ratio|Ratio of non-HDL to HDL at 12 weeks|12 weeks|All patients, irrespective of protocol violations, who had Week 12 measurements, whether on drug or not.||||Standard Deviation|Mean
715622|NCT00249249|Secondary|Triglycerides (TG)|mean triglycerides at 12 weeks|12 weeks|All patients, irrespective of protocol violations, who had Week 12 measurements, whether on drug or not.||mg/dL||Standard Deviation|Mean
715623|NCT00249249|Secondary|TC:HDL-C Ratio|Ratio of mean total cholesterol to mean HDL-C at 12 weeks|12 weeks|All patients, irrespective of protocol violations, who had Week 12 measurements, whether on drug or not.||ratio||Standard Deviation|Mean
715624|NCT00249249|Secondary|Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C)|percent change from baseline in high density lipoprotein-cholesterol (HDL-C)|Baseline to 12 weeks|All patients, irrespective of protocol violations, who had Week 12 measurements, whether on drug or not.||percent change||Standard Deviation|Mean
715625|NCT00249249|Secondary|Percent Change From Baseline in Total Cholesterol (TC)|Percent change in total cholesterol from baseline to Week 12|Baseline to 12 Weeks|All patients, irrespective of protocol violations, who had Week 12 measurements, whether on drug or not.||percent change||Standard Deviation|Mean
715626|NCT00249249|Primary|Percent Change From Baseline Low Density Lipoprotein-cholesterol (LDL-C) at Week 12||Baseline to 12 weeks|All patients, irrespective of protocol violations, who had Week 12 measurements, whether on drug or not.||percent change||Standard Deviation|Mean
715627|NCT00249288|Primary|Efficacy of Folate Supplementation for Reducing Negative Symptoms as Measured by the SANS|The change from baseline to week 12 on the scale for the assessment of negative symptoms (SANS) total score. Total SANS scores range from 0-100. The SANS is comprised of 5 sub-scales: Affective Flattening or Blunting (score range 0-35), Alogia (score range 0-20), Avolition-Apathy (score range 0-15), Anhedonia-Asociality (score range 0-20), and Attention (0-10). For each sub-scale, the higher the score the more prominent the negative symptoms were. The total score was computed by adding all the sub-scale total scores. To compute change in scores, baseline scores were subtracted from week 12 scores, resulting in a change score. Lower values signify greater improvement (i.e. week 12 score was lower than baseline score).|Baseline score vs. week 12 score|||Units on a scale||Standard Deviation|Mean
715628|NCT00249288|Secondary|Correlations Between Red Blood Cell Folate Concentrations and Clinical Ratings of Negative Symptoms and by Comparing Folate Concentrations in Deficit Syndrome Versus Non-deficit Syndrome Patients||12 weeks||||||
715629|NCT00249288|Primary|Correlation Between Baseline Blood Folate, Homocysteine or B12 Levels and Dietary Intake or Cigarette Smoking||12 weeks||||||
715630|NCT00249379|Secondary|Recidivism Rates|Number of participants returning to jail during 12 weeks|12 weeks|"Only 13 Acamprosate participants were analyzed because one participant was lost to follow-up after being given an initial supply of medication for the study.
No data were collected for the Control Arm because funding ran out for the study."||participants|||Number
715632|NCT00249379|Primary|Level of Acceptance|Number of participants taking study medication during 12 weeks|12 weeks|"Only 13 Acamprosate participants were analyzed because one participant was lost to follow-up after being given an initial supply of medication for the study.
No data were collected for the Control Arm because funding ran out for the study."||participants|||Number
715633|NCT00249379|Primary|Drinking and Other Drug Use|Number of participants using alcohol and other drugs during 12 weeks|12 weeks|"Only 13 Acamprosate participants were analyzed because one participant was lost to follow-up after being given an initial supply of medication for the study.
No data were collected for the Control Arm because funding ran out for the study."||participants|||Number
715634|NCT00255684|Secondary|Number of Participants Who Developed Acute Graft Versus Host Disease||3 months|||participants|||Number
715635|NCT00255684|Primary|Number of Participants Who Survived 100 Days or Longer||100 days|||participants|||Number
715636|NCT00255723|Primary|Overall Objective Response|"Overall objective response to therapy Complete remission/unconfirmed (CRu)
This includes patients who meet criteria for CR with the following exceptions:
1. A residual lymph node mass > 1.5 cm in the short axis with normalization of 18Ffluorodeoxyglucose- PET scan Partial remission/minimal response (PR and MR)
Any decrease in lymph nodes and nodal-based masses
Any decrease in PET avidity (however, residual FDG uptake is present)
Involving organs involved prior to therapy must have diminished in size.
No new sites of disease Stable disease Response is less than that which constitutes a PR and disease does not meet criteria for progressive disease Progressive disease
1. Increase in lymph nodes or nodal-based masses, or other measurable disease from pretreatment observations. 2. Appearance of any new lesion at the end of therapy"|3 years|||participants|||Number
715637|NCT00258440|Secondary|Number of Adverse Events (AEs) Experienced as Measure of Safety and Tolerability.||On study, averaging 3 to 6 months.|||events|||Number
715638|NCT00258440|Secondary|Quality of Life at Baseline and Weeks 4, 8, 16, 24, and 28||weeks 4,8,16,24 and 28||||||
715639|NCT00258440|Secondary|Pharmacokinetics (PK) and Pharmacodynamics Assays That Measure Concentration of Erythropoietin in Serum.||every other week||||||
715640|NCT00258440|Primary|Number of Subjects That Maintained Target Hemoglobin Level (11-12 g/dL) Maintenance Weekly for 12 Weeks||12 weeks|Due to low accrual numbers and the discontinuation of the study early a full analysis was not completed.||participants|||Number
715641|NCT00258674|Secondary|"Change Score for Semiannual HbA1c Assessment (as Determined From Medicare Claims Data)"|Each patient was assigned a change score of –1, 0, or 1. A positive value indicated a patient who was non-compliant with the guideline recommendation for a semi-annual HbA1c assessment in the baseline period was compliant in the follow-up period. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.|change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)|Patients for whom records were not available at either baseline or follow-up were excluded.||units on a scale||Standard Deviation|Mean
715642|NCT00258674|Secondary|"Change Score for Annual Lipid Assessment (as Determined From Medicare Claims Data)"|Each patient was assigned a change score of –1, 0, or 1. A positive value indicated a patient who was non-compliant with the guideline recommendation for an annual lipid assessment in the baseline period was compliant in the follow-up period. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.|change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)|Patients for whom records were not available at either baseline or follow-up were excluded.||units on a scale||Standard Deviation|Mean
715643|NCT00258674|Secondary|"Change Score for Annual Eye Exam (as Determined From Medicare Claims Data)"|Each patient was assigned a change score of –1, 0, or 1. A positive value indicated a patient who was non-compliant with the guideline recommendation for an annual eye exam in the baseline period was compliant in the follow-up period. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.|change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)|Patients for whom records were not available at either baseline or follow-up were excluded.||units on a scale||Standard Deviation|Mean
715644|NCT00258674|Secondary|"Change Score for Annual HbA1c Assessment (as Determined From Medicare Claims Data)"|Each patient was assigned a change score of –1, 0, or 1. A positive value indicated a patient who was non-compliant with the guideline recommendation for an annual HbA1c assessment in the baseline period was compliant in the follow-up period. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.|change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)|Patients for whom records were not available at either baseline or follow-up were excluded.||units on a scale||Standard Deviation|Mean
715645|NCT00258674|Secondary|"Change Score for Annual Renal Function Assessment (as Determined From Medical Record Review)"|Each patient was assigned a change score of –1, 0, or 1. A positive value indicated a patient who was non-compliant with the guideline recommendation for an annual renal function assessment in the baseline period was compliant in the follow-up period. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.|change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)|Patients for whom records were not available at either baseline or follow-up were excluded.||units on a scale||Standard Deviation|Mean
715646|NCT00258674|Secondary|"Change Score for Annual Eye Exam (as Determined From Medical Record Review)"|Each patient was assigned a change score of –1, 0, or 1. A positive value indicated a patient who was non-compliant with the guideline recommendation for an annual eye exam in the baseline period was compliant in the follow-up period. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.|change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)|Patients for whom records were not available at either baseline or follow-up were excluded.||units on a scale||Standard Deviation|Mean
715659|NCT00258817|Other Pre-specified|Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1|Solicited local reactions: injection site erythema, injection site swelling, injection site tenderness; Solicited systemic reactions: fever (temperature), irritability, abnormal crying, drowsiness, lost appetite, and vomiting.|0 to 3 days post-vaccination 1|Safety analysis post-vaccination 1 was on all enrolled and vaccinated subjects, Intend-to-treat population.||Participants|||Number
715647|NCT00258674|Secondary|"Change Score for Annual Foot Exam (as Determined by Medical Record Review)"|Each patient was assigned a change score of –1, 0, or 1. A positive value indicated a patient who was non-compliant with the guideline recommendation for an annual foot exam in the baseline period was compliant in the follow-up period. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.|change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)|Patients for whom baseline or follow-up records were not available were excluded.||units on a scale||Standard Deviation|Mean
715648|NCT00258674|Secondary|"Change Score for Annual Blood Pressure Assessment (as Determined From Medical Record Review)"|Each patient was assigned a change score of –1, 0, or 1. A positive value indicated a patient who was non-compliant with the guideline recommendation for an annual blood pressure assessment in the baseline period was compliant in the follow-up period. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.|change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)|Patients for whom either baseline or follow-up records were missing were excluded.||units on a scale||Standard Deviation|Mean
715649|NCT00258674|Secondary|"Change Score for Annual Lipid Assessment (as Determined From Medical Record Review)"|Each patient was assigned a change score of –1, 0, or 1. A positive value indicated a patient who was non-compliant with the guideline recommendation for an annual lipid assessment in the baseline period was compliant in the follow-up period. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.|change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)|Patients for whom either baseline or follow-up records were missing were excluded.||units on a scale||Standard Deviation|Mean
715650|NCT00258674|Secondary|"Change Score for Annual HbA1c Assessment (as Determined From Medical Record Review)"|Each patient was assigned a change score of –1, 0, or 1. A positive value indicated a patient who was non-compliant with the guideline recommendation for an annual HbA1c assessment in the baseline period was compliant in the follow-up period. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.|change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)|Patients for whom records were missing for either baseline or follow-up were excluded.||units on a scale||Standard Deviation|Mean
715651|NCT00258674|Secondary|"Change Score for Systolic Blood Pressure"|Change score was calculated by subtracting the follow-up value from the baseline value for each patient. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.|change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)|Patients missing either a baseline or follow-up blood pressure measurement were excluded.||mmHg||Standard Deviation|Mean
715652|NCT00258674|Secondary|"Change Score for LDL Level"|Change score was calculated by subtracting the follow-up LDL value from the baseline value for each patient. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.|change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)|Patients missing either baseline or follow-up LDL values were excluded.||mg/dL||Standard Deviation|Mean
715653|NCT00258674|Secondary|"Change Score for Diastolic Blood Pressure"|Change score was calculated by subtracting the follow-up value from the baseline value for each patient. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.|change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)|Patients missing either a baseline or follow-up blood pressure measurement were excluded.||mmHg||Standard Deviation|Mean
715654|NCT00258674|Secondary|"Change Score for HbA1c Level"|Change score was calculated by subtracting the follow-up HbA1c value from the baseline value for each patient. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.|change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)|Patients missing either a baseline or follow-up HbA1c value were excluded.||change in percentage of glycosolated-Hb||Standard Deviation|Mean
715655|NCT00258674|Primary|"Change Score for Blood Pressure (b.p.) <130/80 mmHg"|Each patient was assigned a change score of -1, 0, or 1. A positive value indicated that a patient non-adherent to the guideline recommendation of blood pressure <130/80 mmHg at baseline had achieved adherence at follow-up. Patient-level change scores were then summed and averaged over each study arm.|change from baseline (01/01/2000-12/31/2000) to follow-up (01/01/200112/31/2001)|Patients missing either a baseline or follow-up blood pressure value were excluded.||units on a scale||Standard Deviation|Mean
715656|NCT00258674|Primary|"Change Score for LDL <100 mg/dL"|"Each patient was assigned a change score of –1, 0, or 1. A positive value indicated that a patient non-adherent to the guideline recommendation of LDL <100 mg/dL at baseline had achieved adherence at follow-up. Patient-level change scores were then summed and averaged over each study arm."|change from baseline (01/01/2000-12/31/2000) to follow-up (01/01/2001-12/31/2001)|Patients missing either baseline or follow-up LDL values were excluded.||units on a scale||Standard Deviation|Mean
715657|NCT00258674|Primary|"Change Score for HbA1c <9 Percent"|"Each patient was assigned a change score of –1, 0, or 1. A positive value indicated a patient non-adherent to the guideline recommendation for HbA1c <9 percent at baseline had achieved such a level at follow up. Patient-level change scores were then summed and averaged over each study arm."|This measure compared baseline values (01/01/2000-12/31/2000) to follow-up values (01/01/2001-12/31/2001)|Patients missing either baseline or follow-up values for HbA1c were excluded.||units on a scale||Standard Deviation|Mean
715658|NCT00258817|Other Pre-specified|Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 2|"Solicited local reactions: injection site erythema, injection site swelling, injection site tenderness; Solicited systemic reactions: fever (temperature), irritability, abnormal crying, drowsiness, lost appetite, and vomiting
Note: Influenza vaccine-primed group received only dose 1"|0 to 3 days post-vaccination 2|Safety analysis post vaccination 2 was on all enrolled and vaccinated subjects, Intend-to-treat population.||Participants|||Number
715707|NCT00259272|Secondary|Weight Gain Compared to Baseline|Weight gain at anytime more than 7%-15% or 25% of body weight compared to baseline|over 24 weeks|Safety Population. All participants having been prescribed at least one dose of study drug.||participants|||Number
715660|NCT00258817|Primary|Geometric Mean Titer (GMT) of Hemagglutination Inhibition Antibodies Pre-vaccination and 14 Days Post-vaccination|"GMTs and their 95% Confidence interval are presented for each of the 3 antigens in the Fluzone® vaccine 2005-2006 Pediatric formulation.
Post-dose 1 (Influenza vaccine Primed group); post-dose 2 (Influenza vaccine Naive group)"|Day 14 post-vaccination|Geometric Mean Titers were assessed on the per-protocol population.||Titer||95% Confidence Interval|Geometric Mean
715661|NCT00258830|Other Pre-specified|Percentage of Participants With a ≥ 4-fold Increase in Serum Hemagglutination Inhibition Antibody Titers Post-vaccination|Seroconversion: percentage of participants with at least a 4-fold increase in serum hemagglutination inhibition antibody titers at 21 days post-vaccination.|Day 21 post-vaccination|Seroconversion was assessed in the per-protocol population.||Percentage of participants|||Number
715662|NCT00258830|Other Pre-specified|Percentage of Participants With ≥ 40 Serum Hemagglutination Inhibition Antibody Titers Post-vaccination.|Seroprotection: Percentage of participants with ≥ 40 serum hemagglutination inhibition antibody titers 21 days post-vaccination.|21 Days post-vaccination|Seroprotection was assessed in the per-protocol population||Percentage of participants|||Number
715663|NCT00258830|Primary|Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Before and After Fluzone® Vaccination|GMTs and their 95% Confidence Intervals are presented for each of the 3 antigens in Fluzone® vaccine (2005–2006 Formulation)|21 days post-vaccination|GMT results were assessed on the per-protocol population.||Titer||95% Confidence Interval|Geometric Mean
715664|NCT00258830|Primary|Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Fluzone® Vaccination||Day 0 to 3 post-vaccination|Safety analysis was on all enrolled and vaccinated subjects intent-to-treat safety population with available reaction data.||Participants|||Number
715665|NCT00258856|Primary|Percentage of Participants With Serum Bactericidal Activity of ≥ 1:8 for the Menactra® Meningococcal Serogroups Pre-vaccination, and at 7 Days or 14 Days Post-booster or Post-primary Dose Vaccination.|"Groups 1 and 2 received booster vaccination; Groups 3 and 4 received primary vaccination.
Serum bactericidal activity for the Menactra® meningococcal serogroups A, C, Y, and W-135 were at pre-vaccination for all Groups, and at 7 days (Groups 1 and 3), and 14 days (Groups 2 and 4) post-vaccination."|7 or 14 days post-vaccination|Serum bactericidal assay performed using baby rabbit complement (SBA-BR) titers for each of the 4 meningococcal serogroups in the vaccine was evaluated in the per-protocol population.||Percentage of participants|||Number
715666|NCT00258882|Primary|Summary of Fetal Outcomes in Infants Born to Adacel Exposed Pregnant Women and Infants Born to Non-Adacel Exposed Pregnant Controls.|Pregnancies were identified by positive pregnancy tests or prenatal visits within 9 months prior to vaccination with no record of pre-vaccination delivery or abortion, or by prenatal visits, therapeutic abortions, or deliveries within 10 months after vaccination. For all such pregnancies, further review (including chart review, provider and vaccinee interviews, or other appropriate steps) was conducted to identify those for whom it could not be excluded that the individual was pregnant at the time of vaccination or within 28 days thereafter. Such pregnancies were reported by Kaiser Permanente Vaccine Study Center to the Adacel Pregnancy Registry. Maternal and fetal outcomes (up to 1 month of life) were enumerated. For each pregnant Adacel vaccine subjects, 3 age-matched non-Adacel vaccinated controls (± 1 year) that had a first positive pregnancy test during the same month (± 1 month). Rates of events of maternal and fetal outcomes were compared between the 2 groups.|Pregnancy to Delivery, up to 9 months|All persons in the database searches as being vaccinated with Adacel vaccine during pregnancy or within 28 days prior to becoming pregnant and age-matched pregnant controls who did not receive Adacel vaccine.||Infants|||Number
715667|NCT00258882|Primary|Summary of Maternal Outcomes in Pregnant Adacel Recipients and Pregnant Non-Adacel Recipient Controls|Pregnancies were identified by positive pregnancy tests or prenatal visits within 9 months prior to vaccination with no record of pre-vaccination delivery or abortion, or by prenatal visits, therapeutic abortions, or deliveries within 10 months after vaccination. For all such pregnancies, further review (including chart review, provider and vaccinee interviews, or other appropriate steps) was conducted to identify those for whom it could not be excluded that the individual was pregnant at the time of vaccination or within 28 days thereafter. Such pregnancies were reported by Kaiser Permanente Vaccine Study Center to the Adacel Pregnancy Registry. Maternal and fetal outcomes (up to 1 month of life) were enumerated. For each pregnant Adacel vaccine subjects, 3 age-matched non-Adacel vaccinated controls (± 1 year) that had a first positive pregnancy test during the same month (± 1 month). Rates of events of maternal and fetal outcomes were compared between the 2 groups.|Pregnancy to Delivery, up to 9 months|All persons in the database searches as being vaccinated with Adacel vaccine during pregnancy or within 28 days prior to becoming pregnant and age-matched pregnant controls who did not receive Adacel vaccine.||Participants|||Number
715668|NCT00258882|Primary|All Diagnoses (Coded as ICD-9 Codes) Occurring During 6 Months After Vaccination in All Adacel Exposed Individuals in Emergency Department and Hospital Databases.|Comparison of events rates was performed using the historic cohort design in which screening for possible new-onset chronic illnesses during the first 6 months following vaccination was performed. For each age-subgroup event, rates during the 6 months following vaccination among persons receiving Adacel vaccine were compared to event rates during the 6 months following vaccination among persons in the same age subgroup who received Td vaccine, but no live virus vaccine, during the year prior to initiation of this study.|Days 0 to 180 following vaccination|Individuals receiving Adacel vaccine served as their own control for evaluation of acute events.||Events per 1000 Person-months|||Number
715669|NCT00258882|Primary|All Diagnoses (Coded as ICD-9 Codes) Occurring During Specific Periods After Vaccination in All Adacel Exposed Individuals in Emergency Department and Hospital Databases.|Surveillance for acute onset outcomes occurring shortly (days to weeks) after vaccination was performed using the risk-interval cohort design. In this design, the combined experience of individuals receiving Adacel vaccine served as their own control for evaluation of acute events. Rates of events occurring during Days 0 to X (where X = 7, 14, 30, and 60) following vaccination were compared to rates of events occurring in the same individuals during Days 61 to 120 following vaccination|Days 0 to 60 and Day 61 to 120 following vaccination|Individuals receiving Adacel vaccine served as their own control for evaluation of acute events.||Events Per 1000 Person-months|||Number
715708|NCT00259272|Secondary|Mean Change From Baseline to 24 Week Endpoint in Weight||Baseline and 24 weeks|Safety Population. All participants having been prescribed at least one dose of study drug. Number of participants with baseline and at least one non-missing postbaseline value.||kilograms||Standard Deviation|Mean
715670|NCT00258882|Primary|Twenty One Pre-specified Outcomes of Interest (ICD-9 Codes) Captured After Adacel Vaccination in Clinic Database|"The twenty one pre-specified outcomes of special interest screened for in this study included: Arthritis, Arthralgia, or Arthropathy; Bell's Palsy; Diabetes; Encephalitis; Encephalopathy; Febrile Illness; Guillain-Barré; Hemolytic Anemia; Hypersensitivity; ITP; Lupus; Mixed Connective Tissue Disease; Multiple Sclerosis; Neuralgia; Neuritis; Neuropathy; Rheumatoid Arthritis; Scleroderma; Seizure; Severe Local Reaction; Transverse Myelitis.
Comparison of events rates was performed using the historic cohort design in which screening for possible new-onset chronic illnesses during the first 6 months following vaccination was performed. For each age-subgroup event, rates during the 6 months following vaccination among persons receiving Adacel vaccine were compared to event rates during the 6 months following vaccination among persons in the same age subgroup who received Td vaccine, but no live virus vaccine, during the year prior to initiation of this study."|Days 0 up to 180 following vaccination|Individuals receiving Adacel vaccine served as their own control for evaluation of acute events.||Events Per 1000 Person-months|||Number
715671|NCT00258882|Primary|Twenty One Pre-specified Outcomes of Interest as Obtained From International Coding of Diseases (ICD-9) Codes Captured After Adacel Vaccination in Clinical Database|"The twenty one pre-specified outcomes of special interest screened for in this study included: Arthritis, Arthralgia, or Arthropathy; Bell's Palsy; Diabetes; Encephalitis; Encephalopathy; Febrile Illness; Guillain-Barré; Hemolytic Anemia; Hypersensitivity; Idiopathic Thrombocytopenic Purpura (ITP); Lupus; Mixed Connective Tissue Disease; Multiple Sclerosis; Neuralgia; Neuritis; Neuropathy; Rheumatoid Arthritis; Scleroderma; Seizure; Severe Local Reaction; Transverse Myelitis.
Comparison of events rates was performed using the risk-interval cohort design. In this design, the combined experience of individuals receiving Adacel vaccine served as their own control for evaluation of pre-specified outcomes of interest. Rates of events occurring during Days 0 to X (where X = 7, 14, 30, and 60) following vaccination were compared to rates of events occurring in the same individuals during Days 61 to 120 following vaccination."|Days 0 to 60 and Day 61 to 120 following vaccination|Individuals receiving Adacel vaccine served as their own control for evaluation of acute events.||Events Per 1000 Person-months|||Number
715672|NCT00258895|Primary|Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-dose 5 of DAPTACEL® Vaccination||Day 0 and between Days 28-48 post-dose 5|GMTs were assessed for each of the antigens in DAPTACEL vaccine in the per-protocol immunogenicity population.||All units||95% Confidence Interval|Geometric Mean
715673|NCT00258895|Primary|Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Toxoids Responses Pre- and Post-Dose 5 of DAPTACEL® Vaccination.||Day 0 and between Days 28-48 Post-dose 5|Antibody responses were assessed for each of the antigens in DAPTACEL vaccine in the per-protocol immunogenicity population.||Percentage of Participants|||Number
715674|NCT00258895|Primary|Percentage of Participants With Anti-Pertussis Booster Response Post-Dose 5 of DAPTACEL® Vaccination|Booster response calculation: If pre-Dose 5 titer < 4x limit of quantitation (LOQ) a 4-fold rise of post-Dose 5/pre-Dose 5. If pre-Dose 5 titer ≥ 4x LOQ a 2-fold rise of post-Dose 5/pre-Dose 5.|Day 28 to 48 Post-Dose 5|The anti-pertussis booster response was assessed in the per-protocol immunogenicity population.||Percentage of Participants|||Number
715675|NCT00258895|Primary|Percentage of Participants With Anti-Pertussis 4-Fold Rises Post-Dose 5 of DAPTACEL® Vaccination|Anti-Pertussis (anti-Pertussis, anti-Filamentous Haemagglutinin, anti-Fimbriae, and anti-Pertactin) Fold-rise is calculated as post-Dose 5/pre-Dose 5 titer.|Day 28 to 48 Post-dose 5|The anti-Pertussis 4-fold rises were evaluated in the per-protocol immunology population.||Percentage of Participants|||Number
715676|NCT00258895|Primary|Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination||0 to 7 days Post-Dose 5|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.||Percentage of Participants|||Number
715677|NCT00258908|Secondary|Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination|The percentage of participants reporting solicited injection site and systemic reactions within 8 days after vaccination with ADACEL™ (TdcP vaccine) when given as a fifth dose|Within 8 days of vaccination|Safety analysis was on all enrolled and vaccinated participants, intend-to-treat population.||Percentage of Participants|||Number
715678|NCT00258908|Primary|Geometric Mean Titers (GMTs) of Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids Pre- and Post-vaccination|GMTs and 95% confidence intervals of anti-diphtheria, anti-tetanus, and anti-pertussis toxoids responses at Day 0 and Day 28 Post-vaccination.|Day 0 and Day 28 post-vaccination|Geometric Mean Titers were evaluated in the per-protocol immunogenicity population.||Titers||95% Confidence Interval|Geometric Mean
715679|NCT00258908|Primary|Percentage of Participants With Antibody (Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids) Responses Pre- and Post-vaccination|Immunogenicity profile of ADACEL™ (TdcP vaccine) antibody (anti-diphtheria, anti-tetanus, and anti-pertussis) responses at Day 0 and Day 28 Post-vaccination.|Day 0 and Day 28 Post-vaccination|Seroprotection to each vaccine antigen was evaluated in the per-protocol immunogenicity population||Percentage of participants|||Number
715680|NCT00259012|Primary|Normalized Area of Esophageal Hydrogen Ion Activity Over Time|Normalized Area of Esophageal Hydrogen Ion Activity Over Time is a measure of the area under the curve of the esophageal hydrogen ion activity over time, which is normalized for a 24-hour period.|7 days|Patients who had baseline and steady-state pH-metry performed, total pH-metry recording time of at least 16 hours, and received at least 5 consecutive daily doses of pantoprazole before the steady-state pH-metry was performed.||H*mmol/L||Standard Deviation|Mean
715681|NCT00259012|Primary|Normalized Area of Gastric Hydrogen Ion Activity Over Time|Normalized Area of Gastric Hydrogen Ion Activity Over Time is a measure of the area under the curve of the gastric hydrogen ion activity over time, which is normalized for a 24-hour period.|7 days|Patients who had baseline and steady-state pH-metry performed, total pH-metry recording time of at least 16 hours, and received at least 5 consecutive daily doses of pantoprazole before the steady-state pH-metry was performed.||H*mmol/L||Standard Deviation|Mean
715709|NCT00259272|Secondary|Increases and Decreases in Lipid Levels||over 24 weeks|Safety Population. All participants having been prescribed at least one dose of study drug.||participants|||Number
715712|NCT00259272|Secondary|Mean Change From Baseline to 24 Week Endpoint in Glycaemia Levels (Glucose Fasting Levels)||baseline and 24 weeks|Safety Population. All participants having been prescribed at least one dose of study drug. Number of participants with baseline and at least one non-missing postbaseline value.||milligrams per deciliter||Standard Deviation|Mean
715682|NCT00259012|Primary|Percentage of Time That Intraesophageal pH Was <4|Intraesophagel pH is a method for evaluating acidity of gastric refluxate. A lower pH means more acidity. A longer duration of esophageal mucosa exposure to a gastric refluxate with a pH <4.0 correlates with more severe mucosal injury in patients with gastroesophageal reflux disease (GERD).|7 days|Patients who had baseline and steady-state pH-metry performed, total pH-metry recording time of at least 16 hours, and received at least 5 consecutive daily doses of pantoprazole before the steady-state pH-metry was performed.||percentage of time||Standard Deviation|Mean
715683|NCT00259012|Primary|Median Intraesophageal pH|Intraesophagel pH is a method for evaluating acidity of gastric refluxate scaled 0-9. A lower pH means more acidity. A longer duration of esophageal mucosa exposure to a gastric refluxate with a pH <4.0 correlates with more severe mucosal injury in patients with gastroesophageal reflux disease (GERD).|7 days|Patients who had baseline and steady-state pH-metry performed, total pH-metry recording time of at least 16 hours, and received at least 5 consecutive daily doses of pantoprazole before the steady-state pH-metry was performed.||units on scale||Standard Deviation|Mean
715684|NCT00259012|Primary|Mean Intraesophageal pH|Intraesophagel pH is a method for evaluating acidity of gastric refluxate scaled 0-9. A lower pH means more acidity. A longer duration of esophageal mucosa exposure to a gastric refluxate with a pH <4.0 correlates with more severe mucosal injury in patients with gastroesophageal reflux disease (GERD).|7 days|Patients who had baseline and steady-state pH-metry performed, total pH-metry recording time of at least 16 hours, and received at least 5 consecutive daily doses of pantoprazole before the steady-state pH-metry was performed.||units on scale||Standard Deviation|Mean
715685|NCT00259012|Primary|Percentage of Time Intragastric pH Was >4|Intragastric pH is a method for evaluating gastric acidity. A lower pH means more acidity. A longer duration of esophageal mucosa exposure to a gastric refluxate with a pH <4.0 correlates with more severe mucosal injury in patients with gastroesophageal reflux disease (GERD).|7 days|Patients who had baseline and steady-state pH-metry performed, total pH-metry recording time of at least 16 hours, and received at least 5 consecutive daily doses of pantoprazole before the steady-state pH-metry was performed.||percentage of time||Standard Deviation|Mean
715686|NCT00259012|Primary|Median Intragastric pH|Intragastric pH is a method for evaluating gastric acidity scaled 0-9. A lower pH means more acidity. A longer duration of esophageal mucosa exposure to a gastric refluxate with a pH <4.0 correlates with more severe mucosal injury in patients with gastroesophageal reflux disease (GERD).|7 days|Patients who had baseline and steady-state pH-metry performed, total pH-metry recording time of at least 16 hours, and received at least 5 consecutive daily doses of pantoprazole before the steady-state pH-metry was performed.||units on scale||Standard Deviation|Mean
715687|NCT00259012|Primary|Intragastric pH|Intragastric pH is a method for evaluating gastric acidity scaled 0-9. A lower pH means more acidity. A longer duration of esophageal mucosa exposure to a gastric refluxate with a pH <4.0 correlates with more severe mucosal injury in patients with gastroesophageal reflux disease (GERD).|7 days|Patients who had baseline and steady-state pH-metry performed, total pH-metry recording time of at least 16 hours, and received at least 5 consecutive daily doses of pantoprazole before the steady-state pH-metry was performed.||units on scale||Standard Deviation|Mean
715688|NCT00259012|Primary|Pantoprazole Plasma Concentration After Multiple-Dose Oral Administration|Plasma concentration of pantoprazole after multiple doses was measured to see if there was any accumulation of the drug.|7 days|All patients for whom at least 2 PK samples were obtained after 5 consecutive doses. Low dose population was 19 for both 2 and 4 hours. High dose population was 17 and 18 for 2 and 4 hours respectively.||ng/mL||Standard Deviation|Mean
715689|NCT00259012|Primary|Apparent Oral Clearance (CL/F)|Pharmacokinetic (PK) parameters, including apparent oral clearance, were determined following a single oral dose of pantoprazole. Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.|1 day|All patients without any major protocol violations who received 1 dose of pantoprazole on the day the PK samples were obtained, who had at least 4 blood samples, and for whom the pantoprazole terminal-phase disposition half-life could be estimated.||L/hr/kg||Standard Deviation|Mean
715690|NCT00259012|Primary|Area Under the Concentration-time Curve (AUC)|Pharmacokinetic (PK) parameters, including AUC, were determined following a single oral dose of pantoprazole. AUC is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption.|1 day|All patients without any major protocol violations who received 1 dose of pantoprazole on the day the PK samples were obtained, who had at least 4 blood samples, and for whom the pantoprazole terminal-phase disposition half-life could be estimated.||ng*hr/mL||Standard Deviation|Mean
715691|NCT00259012|Primary|Disposition Half-life|Pharmacokinetic (PK) parameters, including the terminal-phase disposition half-life, were determined following a single oral dose of pantoprazole. Half-life is the time required for half the quantity of absorbed drug to be metabolized or eliminated by normal biological processes.|1 day|All patients without any major protocol violations who received 1 dose of pantoprazole on the day the PK samples were obtained, who had at least 4 blood samples, and for whom the pantoprazole terminal-phase disposition half-life could be estimated.||hr||Standard Deviation|Mean
715692|NCT00259012|Primary|Time to Peak Concentration (Tmax) Profile|Pharmacokinetic (PK) parameters, including time to peak plasma concentration, were determined following a single oral dose of pantoprazole.|1 day|All patients without any major protocol violations who received 1 dose of pantoprazole on the day the PK samples were obtained, who had at least 4 blood samples, and for whom the pantoprazole terminal-phase disposition half-life could be estimated.||hr||Full Range|Median
715693|NCT00259012|Primary|Peak Concentration (Cmax)|Pharmacokinetic (PK) parameters, including peak plasma concentration, were determined following a single oral dose of pantoprazole|1 day|All patients without any major protocol violations who received 1 dose of pantoprazole on the day the PK samples were obtained, who had at least 4 blood samples, and for whom the pantoprazole terminal-phase disposition half-life could be estimated.||ng/mL||Standard Deviation|Mean
715710|NCT00259272|Secondary|Mean Change From Baseline to 24 Week Endpoint in Lipids|Baseline, change from baseline, and percent change for the following lipids are presented: Total Cholesterol (TC), High Density Lipoproteins (HDL), Low Density Lipoproteins (LDL), and Triglycerides (TG).|Baseline and 24 Weeks|Safety Population. All participants having been prescribed at least one dose of study drug. Number of participants with baseline and at least one non-missing postbaseline value.||milligrams per deciliter||Standard Deviation|Mean
715694|NCT00259090|Primary|Percentage Change From Baseline to Time of Surgery in Ki67 Labelling Index: Antitumour Effects of Fulvestrant, Anastrozole and a Combination of Both as Measured by the Ki67 Labelling Index.|For each sample, the Ki67 labelling index is calculated as the percentage of cells stained positive for Ki67. Range 0-100. The greater the change from baseline (randomization) in Ki67 labelling index, the greater the blockage of Ki67 expression and the greater the potential anti-tumour activity. Percentage change from baseline=[(SRG - BL)/BL]x100|Surgery (SRG) was to be performed between days 15 and 22 after baseline (BL)|||Percentage change from baseline||Standard Error|Mean
715695|NCT00259090|Primary|Percentage Change From Baseline to Time of Surgery in Progesterone Receptor (PgR) H-score: Antitumour Effects of Fulvestrant, Anastrozole and a Combination of Both as Measured by the PgR H-score.|For each sample, the PgR H-score is calculated from the percentage of cells staining very weak (+/-); weak (+); moderate (++); or strong (+++) as follows: H-score = [(0.5 x percent+/-) + (1 x percent+) + (2 x percent++) + (3 x percent+++)]. Range 0-300. The greater the change from baseline (randomization in PgR H-score, the greater the blockage of PgR expression and the greater the potential anti-tumour activity. Percentage change from baseline=[(SRG - BL)/BL]x100|Surgery (SRG) was to be performed between days 15 and 22 after baseline (BL)|nine patients with PgR=0 at baseline were excluded from analysis of PgR because the question of medical interest was the effect of treatment on PgR positive patients.||Percentage change from baseline||Standard Error|Mean
715696|NCT00259090|Primary|Percentage Change From Baseline to Time of Surgery in Oestrogen Receptor (ER) H-score: Antitumour Effects of Fulvestrant, Anastrozole and a Combination of Both as Measured by the ER H-score.|For each sample, the ER H-score is calculated from the percentage of cells staining very weak (+/-); weak (+); moderate (++); or strong (+++) as follows: H-score = [(0.5 x percent +/-) + (1 x percent +) + (2 x percent ++) + (3 x percent +++)]. Range 0-300. The greater the change from baseline (randomization) in ER H-score, the greater the blockage of ER expression and the greater the potential anti-tumour activity. Percentage change from baseline=[(SRG - BL)/BL]x100|Surgery (SRG) was to be performed between days 15 and 22 after baseline (BL)|||Percentage change from baseline||Standard Error|Mean
715697|NCT00259272|Primary|Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix|This analysis indicates whether the total score is correct and provides enough information, or if subscores need to be calculated. Eigen value, proportion and cumulative are statistical parameters from the Principal Component Analysis, given for each factor.|Baseline|Matrix based on data from all 141 participants.||value|||Number
715698|NCT00259272|Secondary|Emotional Reactivity With the Physiological Measure of Startle Reflex Response - Amplitude of Blink|To assess emotional reactivity with the physiological measure of startle reflex response - by measuring the amplitude of the blink, recorded as a function of slides sessions from the International Affective Picture System, in a defined subgroup of patients.|12 weeks|Measures were to be collected at only one site. Not enough data to analyze.||microvolts||Standard Deviation|Mean
715699|NCT00259272|Secondary|Emotional Reactivity With the Physiological Measure of Startle Reflex Response - Latency of Blink|To assess emotional reactivity with the physiological measure of startle reflex response by measuring the latency of the blink, recorded as a function of slides sessions from the International Affective Picture System, in a defined subgroup of patients.|12 weeks|Measures were to be collected at only one site. Not enough data to analyze.||seconds||Standard Deviation|Mean
715700|NCT00259272|Secondary|Emotional Reactivity With the Physiological Measure of Skin Conductance|To assess emotional reactivity with the physiological measure of skin conductance, recorded as a function of slides sessions from the International Affective Picture System, in a defined subgroup of patients.|12 weeks|Measures were to be collected at only one site. Not enough data to analyze.||microvolts||Standard Deviation|Mean
715701|NCT00259272|Secondary|Emotional Reactivity With the Physiological Measure of Heart Rate|to assess emotional reactivity with the physiological measure of heart rate, recorded as a function of slides sessions from the International Affective Picture System, in a defined subgroup of patients|12 weeks|Measures were to be collected at only one site. Not enough data to analyze.||beats per minute||Standard Deviation|Mean
715702|NCT00259272|Secondary|Change From Baseline to 6 Week and 24 Week Endpoints in YMRS Total Scores - According to Thymic Reactivity Assessment|The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.|Baseline, 6 Weeks, 24 Weeks|Intention to treat. Number of participants with baseline and at least one non-missing postbaseline value.||units on a scale||Standard Deviation|Mean
715703|NCT00259272|Secondary|Change From Baseline to 6 Week and 24 Week Endpoints in HAMD-17 Total Scores - According to Thymic Reactivity Assessment|The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (not at all depressed) to 52 (severely depressed).|Baseline, 6 Weeks, 24 Weeks|Intention to treat. Number of participants with baseline and at least one non-missing postbaseline value.||units on a scale||Standard Deviation|Mean
715704|NCT00259272|Secondary|Change From Baseline to 6 Week and 24 Week Endpoints in HAMA Total Scores - According to Thymic Reactivity Assessment|The 14-item HAMA assesses the severity of anxiety. The investigator talked to the patient about their symptoms over the previous week before the study visit. Each item was scored using a 5-point scale, i.e. 0 = absent to 4 = severe. The total score of HAMA-14 may range from 0 (not present) to 56 (very severe).|Baseline, 6 Weeks, 24 Weeks|Intention to treat. Number of participants with baseline and at least one non-missing postbaseline value.||units on a scale||Standard Deviation|Mean
715705|NCT00259272|Secondary|MATHYS Total Score at Baseline - According to Thymic Reactivity Assessment|A visual analogic scale consisting of 20 items. Items scores vary from 0 (inhibition of the state evaluated by the item) to 10 (excitation for the evaluated state), except for items 5 to 10 and 17 and 18, which are inversed and are consequently to be reversed before the analysis. Total score is sum of the 20 items and can vary from 0 to 200.|Baseline|Intention to treat. Number of participants with baseline and at least one non-missing postbaseline value.||units on a scale||Standard Deviation|Mean
715706|NCT00259272|Secondary|Wellness Interventional Program for Weight Gain Management in Patients (for Those Who Gain at Anytime More Than 7% of Body Weight, Compared to Baseline)||24 weeks|Subgroup of patients who gained more than 7% of body weight.||participants|||Number
715713|NCT00259272|Secondary|Mean Change From Baseline to 6 Week and 24 Week Endpoints in the Young Mania Rating Scale (YMRS) Total Score|The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.|Baseline, 6 Weeks, 24 Weeks|Intention to treat. Number of participants with baseline and at least one non-missing postbaseline value.||units on a scale||Standard Deviation|Mean
715714|NCT00259272|Secondary|Mean Change From Baseline to 6 Week and 24 Week Endpoints in the Hamilton Anxiety Scale (HAMA) Total Score|The 14-item HAMA assesses the severity of anxiety. The investigator talked to the patient about their symptoms over the previous week before the study visit. Each item was scored using a 5-point scale, i.e. 0 = absent to 4 = severe. The total score of HAMA-14 may range from 0 (not present) to 56 (very severe).|Baseline, 6 Weeks, 24 Weeks|Intention to treat. Number of participants with baseline and at least one non-missing postbaseline value.||units on a scale||Standard Deviation|Mean
715715|NCT00259272|Secondary|Mean Change From Baseline to 6 Week and 24 Week Endpoints in the Hamilton 17-Items Depression Scale (HAMD-17) Total Score|The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (not at all depressed) to 52 (severely depressed).|Baseline, 6 Weeks, 24 Weeks|Intention to treat. Number of participants with baseline and at least one non-missing postbaseline value.||units on a scale||Standard Deviation|Mean
715716|NCT00259272|Primary|Mean Changes From Baseline to 6 Week and 24 Week Endpoints in the Multidimensional Assessment of THYmic States Scale (MATHYS) Total Score|A visual analogic scale consisting of 20 items. Item scores vary from 0 (inhibition of the state evaluated by the item) to 10 (excitation for the evaluated state), except for items 5 to 10 and 17 and 18 which are inversed and are consequently to be reversed before the analysis. Total score is sum of the 20 items and can vary from 0 to 200.|Baseline, 6 Weeks, 24 weeks|Intention to treat. Number of participants with baseline and at least one non-missing postbaseline value.||units on a scale||Standard Deviation|Mean
715717|NCT00259285|Secondary|Relapse-free Survival|Results for this outcome measure were not analyzed because the trial stopped early due to low enrollment.|Every 21 day cycle (3 cycles) and then every 3 months for the first 2 years, every 6 months until 5 years have elapsed and annually thereafter|||months||Standard Deviation|Mean
715718|NCT00259285|Secondary|Pathologic Remissions After Surgery|The status of the pathological response was evaluated on the basis of the original results of the histopathological examination of the tumour samples resected. A complete pathological response was defined as the absence of any viable tumour cell in the tumour samples obtained for histological examination.|surgical tumor resection (3-4 weeks after completing three 21-day cycles of therapy)|7 out of the 10 patients had surgery.||participants|||Number
715719|NCT00259285|Primary|Treatment Response|"Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve (respond), stay the same (stable), or worsen (progression) during treatment."|every 21 day cycle (3 cycles) and 3-4 weeks after last cycle|||participants|||Number
715720|NCT00259298|Primary|Change From Baseline in Whole Skeleton Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) to 18 Months|Skeletal plasma clearance is defined as the volume of plasma cleared of tracer (99m Tc-MDP) by the skeleton per unit time (milliliter/minute). Kbone is the rate constant representing plasma clearance of tracer to bone. The Patlak plot method was used to evaluate whole skeleton 99mTc-MDP skeletal plasma clearance (Kbone).|baseline, 18 months|All participants with a baseline observation and at least 1 post-baseline observation.||percentage of change of plasma clearance||Inter-Quartile Range|Median
715721|NCT00259298|Secondary|Number of Participants With Changes in Diffuse Uptake of 99m Tc-MDP - Qualitative Visual Assessment in the Whole Skeleton|Changes in diffuse uptake were determined by comparing diffuse uptake to baseline or other post-baseline observations. Diffuse uptake indicates response to therapy (during active treatment, increased diffuse uptake was expected; after the 6-month withdrawal period, decreased diffuse uptake was expected). Qualitative visual scoring of changes in the bone scan images were performed jointly by 3 reviewers who classified changes in the whole skeleton into 4 groups as follows: possible decreased response, no response, possible response, and definite response.|baseline, 3 months, 18 months, 24 months|All participants with a baseline observation and at least 1 post-baseline observation.||participants|||Number
715722|NCT00259298|Secondary|Change in Qualitative Visual Scores of Focal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton|Changes in focal uptake (localized, defined areas of uptake) were visually scored and compared to baseline or other post-baseline assessments. Changes were rated on a scale from 0-4: 0=no clinically significant focal areas of skeletal uptake; 1=focal areas affecting <1% of skeleton; 2=focal areas affecting >=5% of skeleton; 3=focal areas affecting >=20% of skeleton; 4=focal areas affecting >=50% of skeleton.|Baseline, 3 months, 18 months, 24 months|All participants with a baseline observation and at least 1 post-baseline observation.||units on a scale||Standard Deviation|Mean
715723|NCT00259298|Secondary|Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities|Skeletal uptake describes the percent uptake of radionuclide tracer by the skeleton when compared to baseline or other post-baseline measures. Skeletal uptake is defined as percentage of uptake of 99mTc-MDP 4 hours after injection. This value differs from skeletal plasma clearance measurements because it only quantifies the amount of 99mTc-MDP taken up by bone without consideration of concentration of tracer in the plasma.|Baseline, 3 months, 18 months, 24 months|All participants with a baseline observation and at least 1 post-baseline observation.||percentage of change of skeletal uptake||Inter-Quartile Range|Median
715739|NCT00260195|Primary|Teacher Report of Behavior Problems|Strengths and Difficulties Questionnaire—Parent Report, and Teacher Report (SDQ, Goodman, 1997; Goodman, Meltzer, & Bailey, 1998) This questionnaire contains 25 items, 20 assessing problem areas (emotional symptoms, conduct problems, hyperactivity/inattention, and peer relationship problems), 5 assessing prosocial behavior, and items that tap functional impairment related to these problems (Goodman, 1999). Higher scores indicates more problems, with total problem area scores ranging from 0 to 40.|Problems over the month were assessed at baseline, after intervention for the SSET group (10 weeks), and after all receive intervention (20 weeks).|||units on a scale||Standard Deviation|Mean
715724|NCT00259298|Secondary|Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities|Skeletal plasma clearance is defined as the volume of plasma cleared of tracer (99m Tc-MDP) by the skeleton per unit time (milliliter/minute). Kbone is the rate constant representing plasma clearance of tracer to bone. The Patlak plot method was used to evaluate whole skeleton 99mTc-MDP skeletal plasma clearance (Kbone) and to derive regional values for the skull, mandible, spine, pelvis, and upper and lower extremities.|Baseline, 3 months, 18 months, 24 months|All participants with a baseline observation and at least 1 post-baseline observation.||percentage of change of plasma clearance||Inter-Quartile Range|Median
715725|NCT00259610|Secondary|Radiographic Disease Progression Between Baseline and Week 102 as Assessed by Van Der Heijde Modified Sharp Scores.|Changes in disease progression between treatment groups will be described by the mean score at two years as assessed after adjustment for the baseline radiographic score. Radiographs were observed of hands, wrists, and feet. The range of scores available for the modified Sharp Score is 0 to 448. The erosion score per joint of the hands can range from 0 to 5. The maximal erosion score for each hand is thus 80, considering the 16 areas for erosions per hand. Joint space narrowing and joint subluxation or luxation are combined in a single score with a range of 0 to 4 with a max score of 60. The erosion score per joint can range from 0 to 10, with each side of the joint independently scored from 0 to 5. The maximal erosion score per foot is thus 60. The joint space narrowing and joint (sub)luxation are combined in a single score with a range of 0 to 4. The maximal narrowing/(sub)luxation score per foot is thus 24.|Year 2, Week 102|The participants that were randomized into this clinical trial and completed the study to year 2, represent the number for analysis.||Scores on a scale||Standard Deviation|Mean
715726|NCT00259610|Primary|Disease Activity Score Erythrocyte Sedimentation Rate(DAS28-ESR)|"Outcome measured was the observed-group analysis of the DAS28-ESR between weeks 48 and 102. DAS28 is a calculated scale using a formula that includes the number of tender joints and swollen joints (28 joints maximum). The following is the calculation: DAS28 = 0.56 * sqrt(tender28) + 0.28 * sqrt(swollen28) + 0.70 * ln(ESR) + 0.014 * GH. The ESR is the rate at which red blood cells sediment in a period of one hour.
The total range for the DAS28ESR goes from 0.0 to 9.2; this indicates the current activity of the rheumatoid arthritis of a subject. A DAS28 above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity."|Change of the Mean of DAS28-ESR between weeks 48 - 102.|The participants that were randomized into this clinical trial and completed the study to year 2, represent the number for analysis.||Scores on a scale||Standard Deviation|Mean
715727|NCT00259649|Primary|Change in Mean Headache Index Score Among Patients|Headache index is an average headache severity score recorded using a 0-10 severity scale recorded 4 times daily. Scores are averaged to produce an average severity score which can range between 0 (no headaches) to 10 (always a maximum severity headache). Change in headache activity was evaluated by comparing mean severity scores during the 3 months pre-intervention are compared with 3 months of preventive therapy|baseline to approximately three months|||headache index score||Standard Error|Mean
715728|NCT00259740|Secondary|Complete Response Based on M-Protein Assessments Only|Complete response based on M-protein assessments, as defined for the primary outcome measure.|Up to 18 months|All participants who completed the first cycle of treatment with denosumab||Participants|||Number
715729|NCT00259740|Secondary|Complete Response, Partial Response or Minimal Response Based on M-Protein Assessments Only|Complete response, partial response or minimal response based on serum M-protein assessments. Complete and partial responses are as defined for the primary outcome measure. Minimal response is defined as 25 to 49% reduction from baseline in serum M-protein level, maintained for a minimum of 6 weeks.|Up to 18 months|All participants who completed the first cycle of treatment with denosumab||Participants|||Number
715730|NCT00259740|Primary|Complete Response or Partial Response Based on M-Protein Assessments Only|Complete response or partial response based on serum M-Protein assessments. Complete response is defined as absence of original M-protein in serum by immunofixation, and partial response is defined as ≥ 50% reduction from baseline in serum M-protein, both maintained for a minimum of 6 weeks.|Up to 18 months|All participants who completed the first cycle of treatment with denosumab||Participants|||Number
715731|NCT00259857|Secondary|Participants With Atraumatic Fractures|Number of participants with fractures at the completion of therapy.|24 months|Number of participants with fractures at study completion.||participants|||Number
715732|NCT00259857|Secondary|Participants With Atraumatic Fractures|Number of Participants with Atraumatic fractures before therapy.|0 months|Number of participants with fractures before therapy.||participants|||Number
715733|NCT00259857|Secondary|Number of Participants With Improvement in BMD of Hip|Analysis was done per protocol and intention to treat.|24 months of therapy|Analysis was done per protocol and intention to treat.||participants|||Number
715734|NCT00259857|Primary|Number of Participants With Improvement in Bone Mineral Density (BMD) of Spine After Therapy|BMD of lumbar spine was measured using DXA scan at visit 24 months (Year-2)after alendronate or placebo treatment.|24 months therapy|Analysis was done per protocol and intention to treat.||participants|||Number
715735|NCT00259857|Secondary|Number of Participants With Improvement in Bone Mineral Density (BMD) of Hip After Therapy||12 months of therapy|Analysis was done per protocol and intention to treat.||participants|||Number
715736|NCT00259857|Primary|Number of Participants With Improvement in Bone Mineral Density (BMD) of Spine After Therapy|Participants were screened for BMD of lumbar spine using DXA scan at visit 12 months after alendronate or placebo treatment.|12 months therapy|Analysis was done per protocol and intention to treat.||participants|||Number
715737|NCT00260065|Secondary|Best Response and Overall Improvement|Overall Improvement = complete remission + marrow complete remission + partial remission + hematologic improvement (CR+mCR+PR+HI)|1 year|Intent-to-treat (ITT)||Participants|||Number
715738|NCT00260065|Primary|Number of Participants Who Achieved Overall Response|Overall Response = complete remission (disappearance of all target lesions) + partial remission (at least 30% decrease in the sum of the longest diameters of target lesions)|1 year|Intent-to-treat (ITT)||participants|||Number
715816|NCT00264147|Secondary|Swollen Joint Count (Out of 66 Joints) Time-Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment Period (All Patients-Treated Population)||Time-weighted average change from baseline across Weeks 2, 7, and 12|All-Patients-Treatment Population||Swollen Joint Count||Standard Deviation|Mean
715740|NCT00260195|Primary|Parent Report of Behavioral Problems|Strengths and Difficulties Questionnaire—Parent Report, and Teacher Report (SDQ, Goodman, 1997; Goodman, Meltzer, & Bailey, 1998) This questionnaire contains 25 items, 20 assessing problem areas (emotional symptoms, conduct problems, hyperactivity/inattention, and peer relationship problems), 5 assessing prosocial behavior, and items that tap functional impairment related to these problems (Goodman, 1999). Higher scores indicate more problems, with total scores for problem areas ranging from 0 to 40.|Problems over the prior month were assessed at baseline, after intervention for the SSET group (10 weeks), and after all receive intervention (20 weeks).|||units on a scale||Standard Deviation|Mean
715741|NCT00260195|Primary|Depressive Symptoms|Children’s Depression Inventory (CDI; Kovacs, 1981) This 27-item measure assesses children’s cognitive, affective, and behavioral depressive symptoms. The scale has high internal consistency, moderate test-retest reliability, and correlates in the expected direction with measures of related constructs (e.g., self-esteem, negative attributions, and hopelessness; Kendall, Cantwell, & Kazdin, 1989). Normative data are available (Finch, Saylor, & Edwards, 1985). We used a 26-item version of the scale that omits an item about suicidal ideation. Higher scores indicate more symptoms, and total scores can range from 0 to 52.|Symptoms over the past two weeks were assessed at baseline, after intervention for the SSET group (10 weeks), and after all receive intervention (20 weeks).|||units on a scale||Standard Deviation|Mean
715742|NCT00260195|Primary|Post-traumatic Stress Disorder Symptoms|We used the Child PTSD Symptom Scale (CPSS; Foa,Treadwell, Johnson, & Feeny, 2001), to assess PTSD symptoms for both screening into the program and for use in examining child outcomes over time. This scale has been used in school aged children as young as 8 and has shown good convergent and discriminant validity and high reliability (Foa et al., 2001). In our earlier work, scale internal consistency was high (Cronbach’s alpha = 0.89; Jaycox et al., 2002). In this study, we use it as a continuous scale as designed, and also use cut-points to determine eligibility for the study as in prior work (Kataoka et al., 2003; Stein et al., 2003), requiring a total score of 11 or greater, indicating moderate levels of current PTSD symptoms. A high score indicates more symptoms, and total scores can range from 0 to 51.|Symptoms over the past two weeks were assessed at baseline, after intervention for the SSET group (10 weeks), and after all receive intervention (20 weeks).|||units on a scale||Standard Deviation|Mean
715743|NCT00260208|Secondary|Mean Fibrosis Score|Assessment of hepatic fibrosis was performed with liver biopsies at Day 1, Month 6, 12 and 24, read centrally by two independent pathologists blinded to treatment arm and time of biopsy. Ishak-Knodell score was used to stage liver disease; 0= None; 1= Portal fibrosis (some); 2= Portal fibrosis (most); 3= Bridging fibrosis (few); 4= Bridging fibrosis (many); 5 = Incomplete cirrhosis; 6 = Cirrhosis. Higher score indicates greater fibrosis. The mean score was equivalent to mean of IK at 1 and 2 years (evolution over time).|At 1and 2 years and its evolution over time|This outcome was not analyzed because of premature termination of study.||units on a scale||Standard Deviation|Mean
715744|NCT00260208|Secondary|Percentage of Participants With an Increase of at Least 1 Stage in Fibrosis|Assessment of hepatic fibrosis was performed with liver biopsies at Day 1, Month 6, 12 and 24, read centrally by two independent pathologists blinded to treatment arm and time of biopsy. Ishak-Knodell score was used to stage liver disease; 0= None; 1= Portal fibrosis (some); 2= Portal fibrosis (most); 3= Bridging fibrosis (few); 4= Bridging fibrosis (many); 5 = Incomplete cirrhosis; 6 = Cirrhosis. Higher score indicates greater fibrosis. An increase of at least 1 stage demonstrated a worsening of the disease, i.e. the transition from one score to the next higher one.|Between 1 and 2 years|The outcome measure was not analyzed because of premature termination of study.||Percentage of participants|||Number
715745|NCT00260208|Secondary|Log-transformed Hepatitis C Virus Ribonucleic Acid (HCV RNA) Values up to 1 Year Post Transplant|HCV RNA was measured (IU/µL)centrally pre-transplant (Day 1) and at 48 hours (Day 3), Day 8 and 29, Month 6 and 12 post-transplant and concomitantly to any additional biopsies performed.|Pre-transplant (Day 1), Day , Day 8, Day 29, Month 6 and 12 post- transplant|"Intent-to-treat (ITT) population: all patients as randomized that were transplanted, received at least one dose of study drug and had at least one post-baseline efficacy assessment. n in each of the categories is the number of participants with data at the given time point."||IU/µL||Standard Deviation|Mean
715746|NCT00260208|Secondary|Mean Value of Liver Function Tests at 1 Year Post-transplantation|"The mean value (in Units per liter, IU/L) of following tests were calculated at 1 year post-transplant:
Serum glutamic pyruvic transaminase (SGPT)
Serum Glutamic Oxaloacetic Transaminase (SGOT)
Bilirubin
Alkaline Phosphate
γ-Glutamyltransferase (GGT)"|1 year post-transplant|"Intent-to-treat (ITT) population: all patients as randomized that were transplanted, received at least one dose of study drug and had at least one post-baseline efficacy assessment. n is number participants with assessable data in each category."||IU/L||Standard Deviation|Mean
715747|NCT00260208|Secondary|Number of Participants With Fibrosis Score 2 or Above [Ishak-Knodell Fibrosis Score (FS) ≥ 2] Within 1 Year Post-transplant (Intent to Treat Population)|Assessment of hepatic fibrosis was performed with liver biopsies at Day 1, Month 6, 12 and 24, read centrally by two independent pathologists blinded to treatment arm and time of biopsy. Ishak-Knodell score was used to stage liver disease; 0= None; 1= Portal fibrosis (some); 2= Portal fibrosis (most); 3= Bridging fibrosis (few); 4= Bridging fibrosis (many); 5 = Incomplete cirrhosis; 6 = Cirrhosis. Higher score indicates greater fibrosis.|1 year post-transplant|The Intent-To-Treat (ITT) population consisted of all patients as randomized that were transplanted, received at least one dose of study drug and had at least one post-baseline efficacy assessment.||Participants|||Number
715748|NCT00260208|Secondary|Number of Participants With Death or Re-transplantation Due to Recurrence of Hepatitis C Cirrhosis|Cirrhosis was resulted due to the recurrence of the hepatitis C virus infection in the transplanted liver.|1 year post-transplant|Intent-to-treat (ITT) population: all patients as randomized that were transplanted, received at least one dose of study drug and had at least one post-baseline efficacy assessment.||Participants|||Number
715749|NCT00260208|Secondary|Number of Participants With Combined Endpoint of Death or Graft Loss or Biopsy Proven Acute Rejection (BPAR)|BPAR was defined as a treated acute rejection confirmed by biopsy. The local pathologist graded biopsies according to the Banff (1997) criteria. Graft loss was considered to have occurred when allograft was presumed to be lost if a patient had a liver re-transplant or died.|1 year post-transplant|Intent-to-treat (ITT) population: all patients as randomized that were transplanted, received at least one dose of study drug and had at least one post-baseline efficacy assessment.||Participants|||Number
715750|NCT00260208|Secondary|Number of Participants With Treated Acute Rejection, Biopsy Proven Acute Rejection (BPAR), and Sub-clinical Rejection|Treated acute rejection is defined as an acute rejection, clinically suspected, whether biopsy-proven or not, which has been treated and confirmed by the investigator according to the response to therapy. BPAR was defined as a treated acute rejection confirmed by biopsy. The local pathologist graded biopsies according to the Banff (1997) criteria. A sub-clinical rejection was defined as a rejection identified by center driven biopsy, i.e. a biopsy performed routinely at some pre-defined time points after transplantation as per center practice in the absence of any clinical signs of rejection.|1 year post-transplant|Intent-to-treat (ITT) population: all patients as randomized that were transplanted, received at least one dose of study drug and had at least one post-baseline efficacy assessment.||Participants|||Number
715751|NCT00260208|Secondary|Number of Participants With Death, Graft Loss, Death or Graft Loss, Graft Loss With Re-transplantation|Graft loss was considered to have occurred when allograft was presumed to be lost if a patient had a liver re-transplant or died.|1 year post-transplant|Intent-to-treat (ITT) population: all patients as randomized that were transplanted, received at least one dose of study drug and had at least one post-baseline efficacy assessment.||Participants|||Number
715752|NCT00260208|Secondary|Number of Participants With Fibrosing Cholestatic Hepatitis|Fibrosing cholestatic hepatitis (FCH) is characterized by progressive jaundice with a rapid decline in liver function leading to liver failure, most often associated with markedly elevated viral levels detected in the bloodstream (e.g. more than 20 times pre-liver transplantation levels) and in the liver tissue as well. The presence of FCH was reported based on the diagnosis given by the investigator.|1 year post-transplantation|Intent-to-treat population: all patients as randomized that were transplanted, received at least one dose of study drug and had at least one post-baseline efficacy assessment.||Participants|||Number
715753|NCT00260208|Secondary|Number of Participants With Combined Endpoint of Death or Graft Loss or Fibrosis Score (FS) ≥ 2|The number of participants with combined end point of death or graft loss or presented with a Ishak-Knodell fibrosis score (FS) ≥2 was calculated. Graft loss was considered to have occurred when allograft was presumed to be lost if a patient had liver retransplant or died. Assessment of hepatic fibrosis was performed with liver biopsies read centrally. Ishak-Knodell FS was used to stage liver disease; 0=none; 1=portal fibrosis (some); 2=portal fibrosis (most); 3=bridging fibrosis (few); 4=bridging fibrosis (many); 5=Incomplete cirrhosis; 6=cirrhosis. Higher score indicates greater fibrosis.|1 year post-transplant|Intent-to-treat (ITT) population: all patients as randomized that were transplanted, received at least one dose of study drug and had at least one post-baseline efficacy assessment.||Participants|||Number
715754|NCT00260208|Primary|Number of Participants With Fibrosis Score 2 or Above [Ishak-Knodell Fibrosis Score (FS) ≥ 2] Within 1 Year Post-transplant|Assessment of hepatic fibrosis was performed with liver biopsies at Day 1, Month 6, 12 and 24, read centrally by two independent pathologists blinded to treatment arm and time of biopsy. Ishak-Knodell score was used to stage liver disease; 0= None; 1= Portal fibrosis (some); 2= Portal fibrosis (most); 3= Bridging fibrosis (few); 4= Bridging fibrosis (many); 5 = Incomplete cirrhosis; 6 = Cirrhosis. Higher score indicates greater fibrosis. Logistic regression on the presence of IK>=2 was applied based on central biopsy readings only.|1 year post-transplant|The modified intent-to-treat population (mITT) included patients treated with study drug at least up to 30 days before Month 12 visit and a liver biopsy had to be performed at this visit. Also included were patients with an earlier biopsy that showed an Ishak-Knodell fibrosis score ≥2 and treated at least up to 30 days before that biopsy was taken.||Participants|||Number
715755|NCT00260429|Secondary|Change From Baseline Range of Motion After the First Injection||30 days after first treatment to the primary joint||||||
715756|NCT00260429|Secondary|Percent Reduction From Baseline Contracture After the First Injection||30 days after first treatment to the primary joint||||||
715757|NCT00260429|Secondary|Clinical Success After the First Injection||30 days after first treatment to the primary joint||||||
715758|NCT00260429|Secondary|Time to First Achieve and Maintain Clinical Success After the Last Injection||First evaluation visit on which clinical success is achieved and maintained through the Day 30 evaluation of the primary joint||||||
715759|NCT00260429|Secondary|Percent Change From Baseline Range of Motion After the Last Injection||30 days after last treatment to the primary joint||||||
715760|NCT00260429|Secondary|Percent Reduction From Baseline Contracture After the Last Injection||30 days after last treatment to the primary joint||||||
715761|NCT00260429|Primary|Primary Outcome Measure is Reduction of Flexion Contracture of the Primary Joint.|"The Primary Outcome Measure for patients treated with AA4500 is the percentage of 23 joints that were successfully treated where successfully treated was defined as reduction in contracture to 5° or less.
The Primary Outcome Measure for placebo treated patients is the percentage of 12 joints that were successfully treated where successfully treated was defined as reduction in contracture to 5° or less."|30 days after the last injection|||% Joints|||Number
715762|NCT00260533|Primary|Clinical Global Impression (Change Version, Also Known as Improvement Version)|"This is a commonly used, clinician-rated measure of clinical improvement.
The Clinical Global Impression – Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.
For purposes of analysis, subjects rated as (1) Very Much Improved or (2) Much Improved were considered responders."|10 weeks (end of study)|||participants|||Number
715763|NCT00260689|Primary|Hematologic Response|"Hematologic response is defined as subjects having blood counts no longer meeting the standard (Camitta) criteria for severe pancytopenia in Severe Aplastic Anemia, equivalent to 2 of the following values obtained on 2 serial blood count measurements at least one week apart at landmark time points (3, 6 and 12 months)
Absolute neutrophil count > 500/ μL
Platelet count > 20,000/ μL
Reticulocyte count > 60,000/ μL
Improvement in counts that are dependent upon exogenously administered growth factors or transfusion will not be considered as fulfilling response criteria."|12 months|||Participants|||Count of Participants
715817|NCT00264147|Secondary|Tender Joint Count (Out of 68 Joints) Time-Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment Period (All Patients-Treated Population)||Time-weighted average change from baseline across Weeks 2, 7, and 12|All-Patients-Treatment Population||Tender Joint Count||Standard Deviation|Mean
715764|NCT00260689|Primary|Hematologic Response|"Hematologic response is defined as subjects having blood counts no longer meeting the standard (Camitta) criteria for severe pancytopenia in Severe Aplastic Anemia, equivalent to 2 of the following values obtained on 2 serial blood count measurements at least one week apart at landmark time points (3, 6 and 12 months)
Absolute neutrophil count > 500/ μL
Platelet count > 20,000/ μL
Reticulocyte count > 60,000/ μL
Improvement in counts that are dependent upon exogenously administered growth factors or transfusion will not be considered as fulfilling response criteria."|6 months|||Participants|||Count of Participants
715765|NCT00260689|Primary|Hematologic Response|"Hematologic response is defined as subjects having blood counts no longer meeting the standard (Camitta) criteria for severe pancytopenia in Severe Aplastic Anemia, equivalent to 2 of the following values obtained on 2 serial blood count measurements at least one week apart at landmark time points (3, 6 and 12 months)
Absolute neutrophil count > 500/ μL
Platelet count > 20,000/ μL
Reticulocyte count > 60,000/ μL
Improvement in counts that are dependent upon exogenously administered growth factors or transfusion will not be considered as fulfilling response criteria."|3 months|||Participants|||Count of Participants
715766|NCT00260832|Secondary|Comparison of Complete Remission Rates Between Arm A and Arm B|Morphologic complete remission (CR) plus CR without platelet recovery (CRp) rate|Post randomization when at least one post-baseline bone marrow assessment or peripheral blood count data available. No stated duration of response required for complete remission classification||||||
715767|NCT00260832|Primary|Overall Survival in Patients 65 Years or Older Who Have Newly Diagnosed de Novo or Secondary AML.|The interval from date of randomization to the date of death from any cause or the last date the subject was known to be alive or 5 years whichever occurs first.|The interval from date of randomization to the date of death from any cause or the last date the subject was known to be alive or 5 years whichever occurs first.|The primary population for all efficacy analyses was the Intent-to-treat (ITT) population defined as all subjects randomly allocated to a treatment arm.||months||Full Range|Median
715768|NCT00252382|Secondary|Best Overall Response|Based on RECIST criteria|2 years|Efficacy Analysis Population||Participants|||Count of Participants
715769|NCT00252382|Primary|Objective Tumor Response Rate|ORR is based on RECIST criteria to SNS-595 as a second-line therapy in patients with advanced NSCLC|24 months|Efficacy Analysis Population||Participants|||Count of Participants
715770|NCT00252499|Secondary|Change in Hepatic Insulin Sensitivity From Baseline to 6 Months|Hepatic insulin sensitivity was determined as the percent suppression of endogenous glucose production (EGP) at the end of the low dose insulin clamp.|6 months|||percent of baseline EGP||Standard Error|Mean
715771|NCT00252499|Secondary|Changes in Intra-abdominal Fat Area From Baseline to 6 Months|Unenhanced CT scan images were obtained on a General Electric Discovery HD750 CT scanner. Intra-abdominal (IAF) areas were measured at the top of the iliac crest and quantified using the Tomovision program (SliceOMatic V4.3) by one trained technologist.|6 months|||mm2||Standard Error|Mean
715772|NCT00252499|Secondary|Change in Peripheral Insulin Sensitivity From Baseline to 6 Months|A two-step stable isotope labeled, hyperinsulinemic-euglycemic clamp procedure was performed with a low dose insulin infusion (20 mU/m2/min) for 3 hours followed by a primed high dose insulin infusion (160 mU/m2/min x 5 minutes then 80 mU/m2/min) for two hours. D20 was infused and adjusted to maintain the blood glucose at 90 mg/dl. Samples for glucose, insulin and 6,6 2d glucose were drawn every 15 minutes during the final half hour of the basal, low dose and high dose insulin periods. Whole body insulin sensitivity was calculated as the rate of glucose disposal (Rd)/lean body mass during the high dose insulin infusion.|6 months|One person in Arm 1 dropped out and thus is lacking 6 month data. The 6 month isotope data to calculate the rate of glucose disposal was not available for one subject in Arm 3.||mg/min/kg||Standard Error|Mean
715773|NCT00252499|Secondary|Change in the Liver Spleen Ratio by CT Scan From Baseline to 6 Months as a Measure of Fat in the Liver||6 months|||ratio||Standard Error|Mean
715774|NCT00252499|Secondary|Change in Alanine Aminotransferase (ALT) Levels From Baseline to 6 Months||6 months|||U/L||Standard Error|Mean
715775|NCT00252499|Primary|Liver/Spleen Ratio at 6 Months|Liver fat was estimated by non-contrast CT scan measuring the density ratio between the liver and spleen by Hounsfield units (liver/spleen ratio), which has been previously correlated with liver fat quantification by magnetic resonance spectroscopy.Ten separate measurements equally distributed throughout the liver and spleen were obtained and the Hounsfield units averaged. In subjects with more than one slice through the liver and spleen, the values for all slices were averaged.|6 months|||ratio||Standard Error|Mean
715776|NCT00252512|Secondary|Employment, Housing, Legal, and Psychiatric Status at Two, Six, and 12 Month Follow-up Interviews; Administrative Data on VA Service Utilization at Six and 12 Month Follow-ups.||8 weeks, 6 months, 12 months||||||
715777|NCT00252512|Primary|Number of Negative Breath Alcohol and Urine Drug Screens Out of Possible 16||8 weeks|||negative alcohol and drug screens||Standard Deviation|Mean
715778|NCT00252538|Primary|Phenotype and Genotype Based on Presence of Interferon Induced MDD.|"Structured psychiatric interviews and symptom rating scales for depression were used as primary outcome measures to determine the association between phenotype (interferon-induced depression) and genotype (genes that confer risk of interferon-induced depression). Genes of interest related to development of depression and antiviral treatment response that may confer risk for interferon induced depression were examined. this was a multi-site study and included participants from several hospital settings.
Three polymorphisms of the interleukin (IL)-28b gene were examined - the c/c, c/t and t/t - and the relationship to MDD was examined. P-values above 0.05 are considered statistically insignificant in this study.
In a subsequent analysis of only VA participants proinflammatory cytokines and serotonin levels were examined relative to symptoms of depression."|The proposed enrollment began after funding notification and enrollment will last for a period of 40 months and until end of study.|This is an observational study that segregates patients with HCV and on interferon alpha treatment into 2 groups based on whether they develop major depressive disorder (MDD) while on interferon alpha therapy for HCV and then examines genes that may confer risk for MDD development. group 1 MDD and group 2 no MDD. total sample from multiple sites.||participants|||Number
715818|NCT00264147|Primary|Proportion of Patients Who Met the ACR20 Responder Index Criteria|Proportion of Patients Who Met the American College of Rheumatology Response Index (20%) Criteria (ACR20) (Based on the Time-Weighted Average Responses of the 12-Week Treatment I Period and Completed the Treatment I Period) (All Patients-Treated Population)|12 weeks|All-Patients-Treated Population||Proportion of Patients|||Number
715779|NCT00252564|Secondary|Overall Response Rate|Percentage of patients with tumor response (by RECIST criteria, including complete response, or CR, i.e. disappearance of all target lesions; and partial response, or PR, i.e. at least a 30% decrease in the sum of the longest diameters of target lesions taking as reference the baseline sum of the longest diameters) among all “per-protocol population” patients.|(during the whole treatment period)|This analysis included all eligible and treated patients, i.e. per-protocol population. A patient will be considered in the arm he/she is actually treated, not randomized.||%||95% Confidence Interval|Number
715780|NCT00252564|Secondary|Overall Survival (OS)|"From randomization to death (event); or last follow-up date if alive (censoring).
Kaplan-Meier OS median time."|(no predetermined maximum time)|This analysis included all registered (or randomized) patients, i.e. intent-to-treat (ITT) population, regardless of patient’s treatment status.||Month||95% Confidence Interval|Median
715781|NCT00252564|Primary|Progression-free Survival (PFS)|"From randomization to first progression or death, whichever comes first (event); or first new anti-cancer treatment if before or without progression / death (censoring); or last follow-up date otherwise (censoring).
Kaplan-Meier median PFS time and PFS rate at 12 months."|(no pre-determined maximum time. PFS rate at 12 months)|This analysis included all registered (or randomized) patients, i.e. intent-to-treat (ITT) population, regardless of patient’s treatment status.||%||95% Confidence Interval|Number
715782|NCT00252564|Primary|Progression-Free Survival (PFS)|"From randomization to first progression or death, whichever comes first (event); or first new anti-cancer treatment if before or without progression / death (censoring); or last follow-up date otherwise (censoring).
Kaplan-Meier median PFS time and PFS rate (at 12 months)"|(no pre-determined maximum time)|This analysis included all registered (or randomized) patients, i.e. intent-to-treat (ITT) population, regardless of patient’s treatment status.||month||95% Confidence Interval|Median
715783|NCT00252590|Secondary|Percentage of Days Abstinent From All Substances|Percentage of days abstinent from both alcohol and drugs|4 months|||percentage of days abstinent||Standard Deviation|Mean
715784|NCT00252590|Primary|Percentage of Days Abstinent From Alcohol||4 months|||percentage of days abstinent alcohol||Standard Deviation|Mean
715785|NCT00252629|Primary|The Prevalence of Inspiratory Flow Limitation (IFL) During Sleep in GWS.|"IFL was determined by plotting inspiratory flow against supra-glottic pressure for each breath sampled during continuous stage 2 sleep on a full night polysomnogram on both veterans with GWS and asymptomatic gulf war veterans.
We expressed the prevalence of inspiratory flow limitations during sleep as the percentage of flow limited breath in the sample of both GWS and asymptomatic gulf was veterans."|On a full night polysomnogram|||percentage of flow limited breaths||Standard Deviation|Mean
715786|NCT00252629|Secondary|Change of Cognitive Dysfunction|Cognition dysfunction- increasing difficulty with memory, ability to think, and ability to concentrate was rated 0-10 daily by visual analogue scale, where 0 no problem and 10=severe problems.|3 weeks treatment with either therapeutic or sham CPAP|||units on a scale||Standard Deviation|Mean
715787|NCT00252629|Secondary|Change of Pain Complaint|"Pain- increased level were rated 0-10 by visual analogue scale, where 0= no pain and 10= severe pain.
We compared the change of pain symptom before and after treatment of either 3 weeks on therapeutic nasal CPAP or sham nasal CPAP"|3 weeks of treatment on either therapeutic or sham nasal CPAP|||units on a scale||Standard Deviation|Mean
715788|NCT00252629|Primary|Change of Fatigue Symptom|Fatigue- increasing impact was rated 1-7 using the fatigue severity scale on days 1 and 7 averaged, where 1= no fatigue and 7= severe fatigue.|3 weeks treatment with either therapeutic or sham CPAP|||units on a scale||Standard Error|Mean
715789|NCT00252694|Secondary|Rate of Change in Urinary Albumin Excretion Rate (UAER).|An estimate of the slope from fitting a linear regression of log(UAER) over time (post-randomisation, yearly assessments) for each patient.|From Baseline to end of study, i.e. 5 years.|The population was the Intention To Treat population which includes all randomized patients with any post-randomization data.||log (µg/min)/1000 year||95% Confidence Interval|Least Squares Mean
715790|NCT00252694|Secondary|Number of Participants With Incident Clinically Significant Macular Edema (CSME) and/or Proliferative Diabetic Retinopathy (PDR).|Clinically Significant Macular Edema (CSME) and Proliferative Diabetic Retinopathy (PDR) are diagnosed via retinal photographs.|From baseline to end of study, i.e. 5 years.|The population was the Intention To Treat population which includes all randomized patients with any post-randomization data.||Participants|||Number
715791|NCT00252694|Secondary|Number of Participants With at Least a 3 Step Improvement or a Persistent 2-step Improvement in the ETDRS Severity Scale.|3 steps were defined as either a 1-step change in one eye and a 2-step change in the other eye or as a 3-step change in one eye only. EDRTS is a scale with 11 steps (1-11).|From baseline to end of study, i.e. 5 years.|The population was the Intention To Treat population which includes all randomized patients with any post-randomization data.||Participants|||Number
715792|NCT00252694|Primary|Number of Participants With a 3-step or Greater Increase in Early Treatment of Diabetic Retinopathy Study (EDTRS) Severity Scale|3 steps were defined as either a 1-step change in one eye and a 2-step change in the other eye or as a 3-step change in one eye only. EDRTS is a scale with 11 steps (1-11). A generlized log-rank test was used to test difference between treatments.|From baseline to end of study, i.e. 5 years, with visits after a half year, one year and thereafter one visit per year.|The population was the Intention To Treat population which includes all randomized patients with any post-randomization data.||Participants|||Number
715793|NCT00252720|Secondary|Rate of Change in Urinary Albumin Excretion Rate (UAER).|An estimate of the slope from fitting a linear regression of log (UAER) over time (post-randimisation, yearly assessments) for each patient|From baseline to end of study, i.e. 5 years.|The population was the Intention To Treat population which includes all randimized patients with any post-randomization data.||log (µg/min)/year||95% Confidence Interval|Least Squares Mean
715794|NCT00252720|Secondary|Number of Participants With Incident Clinically Significant Macular Edema (CSME) and/or Proliferative Diabetic Retinopathy (PDR).|Clinically Significant Macular Edema (CSME) and Proliferative Diabetic Retinopathy (PDR) are diagnosed via retinal photographs.|From baseline to end of study, i.e. 5 years.|The population was the Intention To Treat population whick includes all randomized patients with any post-randomization data.||Participants|||Number
716048|NCT00266032|Secondary|Number of Bleeding / Spotting Days by 90-day Reference Period|The mean number of bleeding / spotting days, spotting-only and bleeding days was analyzed using reference periods of 90 days as recommended by the WHO.|up to 1 year|FAS (reflecting ITT), all treated subjects, no imputation||Days||Standard Deviation|Mean
715795|NCT00252720|Secondary|Number of Participants With a Regression of Diabetic Retinopathy.|Regression of diabetic retinopathy was defined as at least a 3 step improvement or a persistent 2-step improvement (confirmed in 2 consecutive photography sets) in the Early Treatment of Diabetic Retinopathy Study (ETDRS) severity scale. 3 steps were defined as either a 1-step change in one eye and a 2-step change in the other eye or as a 3-step change in one eye only. EDRTS is a scale with 11 steps (1-11).|From baseline to the end of the study, i.e., 5 years|The population was the Intention To Treat population which includes all randomized patients with any post-randomization data.||Participants|||Number
715796|NCT00252720|Primary|Number of Participants With a 3-step or Greater Increase in Early Treatment of Diabetic Retinopathy Study (EDTRS) Severity Scale|Retinopathy progression was defined as the first occurrence of at least a 3-step increase in the ETDRS severity scale. 3 steps were defined as either a 1-step change in one eye and a 2-step change in the other eye or as a 3-step change in one eye only. EDRTS is a scale with 11 steps (1-11). A generlized log-rank test was used to test difference between treatments.|From baseline to end of study, i.e. 5 years, with visits after a half year, one year and thereafter one visit per year.|The population was the Intention to Treat population which includes all randomized patients with any post-randomization data.||Participants|||Number
715797|NCT00252733|Secondary|Rate of Change in Urinary Albumin Excretion Rate (UAER).|An estimate of the slope from fitting a linear regression of log(UAER) over time for each patient.|From baseline to end of study, i.e. 5 years.|The population was the Intention To Treat population which includes all randomized patients with any post-randomization data.||log (µg/min)/year||95% Confidence Interval|Least Squares Mean
715798|NCT00252733|Primary|Number of Participants With a 2-step or Greater Increase in Early Treatment Diabetic Retinopathy Study (ETDRS) Severity Scale.|Two steps were defined as either a 1-step change in each eye or as a 2-step change in one eye only. ETDRS is a scale with 11 steps (1-11, where a score of 1 represents no retinopathy and a score of 11 represents proliferative retinopathy). A generalized log-rank test was used to test difference between treatments.|From baseline to end of study, i.e. 5 years, with visits after a half year, one year and thereafter one visit per year.|The population was the Intention To Treat population which includes all randomized patients with any post-randomization data.||Participants|||Number
715799|NCT00260962|Secondary|Obsessions|Obsessions subscale of the Yale-Brown Obsessive Compulsive Scale. Minimum score is 0 and maximum score is 20. Higher scores indicate higher levels of obsessions.|Pretreatment (Week 1) and Posttreatment (Week 13)|||units on a scale||Standard Deviation|Mean
715800|NCT00260962|Primary|Body Mass Index (BMI) (kg/m^2)|Body Mass Index (BMI) measured in kg/m^2 units. Measured at Baseline (week 2) and post-treatment (week 13).|Baseline (week 2) and post-treatment (week 13)|4 participants discontinued in placebo group and 2 did not have weight measurements at week 13. 2 participants discontinued in the olanzapine group||kg/m^2||Standard Deviation|Mean
715801|NCT00263887|Secondary|Quality of Life With a Disease Specific Instrument, the St. George's Respiratory Questionnaire||24 or 30 months||||||
715802|NCT00263887|Secondary|Mortality||24 or 30 months||||||
715803|NCT00263887|Secondary|Duration and Severity of the Exacerbations||24 or 30 months||||||
715804|NCT00263887|Secondary|The Deterioration of the Lung Function Will be Assessed by Measurement of the Change in Forced Expiratory Volume at One Second (FEV1) and Transfer Factor of Carbon Monoxide (KCO)||24 or 30 months||||||
715805|NCT00263887|Secondary|The Frequency of Exacerbations as Determined by Patient Diary.||24 or 30 months||||||
715806|NCT00263887|Secondary|Change in Lung Density at Each Visit as Measured by Computed Tomography||24 or 30 months||||||
715807|NCT00263887|Primary|The Progression Rate of Emphysema Determined by Change in 15th Percentile of Lung Density Measured by Annual CT Scan of the Whole Lung||24 or 30 months|The modified Intent-To-Treat Population was defined as all subjects in the Intent-To-Treat (ITT) Population (all randomized subjects) who had a valid baseline CT scan and at least one valid post-baseline CT scan measurement.||g/L||Standard Deviation|Mean
715808|NCT00264004|Secondary|Best Percentage Change in Tumour Size|Maximum percentage reduction or minimum percentage increase in tumour size where size is the sum of the longest diameters of the target lesions. Based on the baseline scaled ratio: ratio of the post-randomisation visit tumour size divided by the baseline tumour size.|Randomisation until end of treatment period|||percentage of tumor size||90% Confidence Interval|Geometric Mean
715809|NCT00264004|Secondary|Objective Response Rate|Number of patients with complete or partial response (CR/PR), based on RECIST|12 week treatment period|||Participants|||Number
715810|NCT00264004|Secondary|Proportion of Patients Requiring Temporary (>1 Day) or Permanent Withdrawal of AZD2171 Prior to Progression and Within 6 Weeks of First Dose of AZD2171||First 6 weeks of 12 week treatment period|||Participants|||Number
715811|NCT00264004|Primary|Proportion of Planned Dose Received During First 12 Weeks of Therapy With AZD2171|Total actual dose received during the first 12 weeks prior to progression divided by the planned dose (planned dose: initial allocated dose multiplied by the number of days on study during the first 12 weeks prior to progression)|12 week treatment period|||Poportion of Planned Dose||90% Confidence Interval|Median
715812|NCT00264004|Primary|Proportion of Patients Requiring Temporary (>1 Day) or Permanent Withdrawal of AZD2171 Prior to Progression and Within 12 Weeks of First Dose of AZD2171||12 week treatment period|||Participants|||Number
715813|NCT00264147|Secondary|Patient Global Assessment of Pain (0- to 100-mm Visual Analog Scale) Time Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment I Period (All Patients-Treated Population)|0-mm indicates very well, 100-mm indicates very poor.|Time-weighted average change from baseline across Weeks 2, 7, and 12|All-Patients-Treated Population||Units on a Scale||Standard Deviation|Mean
715814|NCT00264147|Secondary|Investigator Global Assessment of Disease Activity (0- to 4-Likert Scale) Time Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment I Period (All Patients-Treated Population)|0 indicates very well, 4 indicates very poor.|Time-weighted average change from baseline across Weeks 2, 7, and 12|All-Patients-Treatment Population||Units on a Scale||Standard Deviation|Mean
715815|NCT00264147|Secondary|Patient Global Assessment of Disease Activity (0- to 100-mm Visual Analog Scale) Time Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment I Period (All Patients-Treated Population)|0-mm indicates very well, 100-mm indicates very poor.|Time-weighted average change from baseline across Weeks 2, 7, and 12|All Patients-Treated Population||Units on a Scale||Standard Deviation|Mean
715819|NCT00264238|Secondary|Mean Change in Montgomery-Asberg Depression Rating Scale (MADRS) From Baseline to End of Treatment (12 Weeks)|The Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. Each item is rated on a scale of 0 (no symptoms) to 6 (extreme symptoms) and items are summed. The overall score ranges from 0 to 60. Higher MADRS score indicates more severe depression.|Baseline and 12 weeks|||units on a scale||Standard Deviation|Mean
715820|NCT00264238|Primary|Mean Change in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) From Baseline to End of Treatment (12 Weeks)|The Yale-Brown Obsessive Compulsive Scale (Y-BOCS) is designed to rate the severity and type of symptoms in patients with obsessive compulsive disorder. In general, the items depend on the patient's report; however, the final rating is based on the clinical judgement of the interviewer. The Y-BOCS is designed to rate symptom severity, not to establish a diagnosis.The scale consists of 10 items summed to determine the level of symptom severity. The total score ranges from 0 to 40 with higher scores indicating greater symptom severity|Baseline and 12 weeks|||units on a scale||Standard Deviation|Mean
715821|NCT00264290|Secondary|Change in CD4 Counts and Plasma HIV RNA Levels After a 4-week Washout Period||Week 12||||||
715822|NCT00264290|Secondary|Change in CMV DNA Shedding After a 4-week Washout Period||Week 12||||||
715823|NCT00264290|Secondary|%CD38+HLA-DR+ CD8+ T Cells After a 4-week Washout Period||Week 12||||||
715824|NCT00264290|Secondary|Change in Cluster of Differentiation 4 (CD4) Counts and Plasma HIV RNA Levels at Week 8.||week 8||||||
715825|NCT00264290|Secondary|Change in CMV DNA Shedding From Baseline to Week 8.|Change in percentage of participants with detectable CMV DNA. Herpesvirus DNA levels were assessed by polymerase chain reaction (lower limit of detection, 150 copies/mL) on saliva and seminal plasma.|week 8||||||
715826|NCT00264290|Primary|Change in %CD38+ Human Leukocyte Antigen-D-related (HLA-DR)+ CD8+ T Cells From Baseline to Week 8.|The percentage of activated (CD38+ HLA-DR+) CD8+ T cells was measured on fresh whole blood at screening/baseline. T cell activation was measured on peripheral blood mononuclear cells (PBMCs)in batch at the end of the study.|Baseline, 8 weeks|||percentage of activated T cells||95% Confidence Interval|Mean
715827|NCT00264303|Primary|Mean Pruritus Severity Score Over the First Week of Treatment|Pruritus severity is evaluated on an ordinal 4-point scale from 0 to 3 (0=none, 1=mild, 2=moderate). Mean pruritus severity score is averaged over the first week of treatment.|over the first week of treatment|ITT population||Units on a scale||Standard Error|Least Squares Mean
715828|NCT00264303|Secondary|Mean Score for Pruritus Duration Over the Four Weeks of Treatment|The pruritus duration score is evaluated on an ordinal 4-point scale (0=no pruritus, 1=less than 1 hour, 2=1 to 6 hours, 3=more than 6 hours). Mean score for pruritus duration is averaged over the four weeks of treatment.|over the four weeks of treatment|Intent to treat (ITT) Population||Units on a scale||Standard Error|Least Squares Mean
715829|NCT00264303|Secondary|Mean Score for Pruritus Duration Over the First Week of Treatment|The pruritus duration score is evaluated on an ordinal 4-point scale (0=no pruritus, 1=less than 1 hour, 2=1 to 6 hours, 3=more than 6 hours). Mean score for pruritus duration is averaged over the first week of treatment.|over the first week of treatment|Intent to treat (ITT) Population||Units on a scale||Standard Error|Least Squares Mean
715830|NCT00264303|Secondary|Mean Pruritus Severity Score Over the Four Weeks of Treatment|Pruritus severity is evaluated on an ordinal 4-point scale from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe/intense). Mean pruritus severity score is averaged over the four weeks of treatment.|over the four weeks of treatment|Intent to treat (ITT) Population||Units on a scale||Standard Error|Least Squares Mean
715831|NCT00264303|Secondary|Mean Chronic Idiopathic Urticaria (CIU) Composite Score Over the Four Weeks of Treatment|CIU composite score is defined as the sum of two scores defined on an ordinal 4-point scale (pruritus severity score: 0=none, 1=mild, 2=moderate, 3=severe/intense; score for the number of wheals/24 h: 0=none, 1=mild or <=20 wheals, 2=moderate or 21-50 wheals/24 h, 3=severe/intense or >50 wheals/24 h). Mean is averaged over the 4 weeks of treatment.|over the four weeks of treatment|Intent to treat (ITT) Population||Units on a scale||Standard Error|Least Squares Mean
715832|NCT00264303|Secondary|Mean Chronic Idiopathic Urticaria (CIU) Composite Score Over the First Week of Treatment|CIU composite score is defined as the sum of 2 scores defined on an ordinal 4-point scale (pruritus severity score: 0=none, 1=mild, 2=moderate, 3=severe/intense; score for the number of wheals/24 h: 0=none, 1=mild or <=20 wheals, 2=moderate or 21-50 wheals/24 h, 3=severe/intense or >50 wheals/24 h). Mean is averaged over the 1st week of treatment.|over the first week of treatment|Intent to treat (ITT) population||Units on a scale||Standard Error|Least Squares Mean
715833|NCT00264381|Secondary|Change From Baseline to Day 14 in Pain Assessment|Change in pain at day 14 as measured by 11-point Box Pain Scale, 0 being the least amount of pain, and 10 the most amount of pain|Day 1, Day 14|Participants available at follow up||units on a scale||Standard Deviation|Mean
715834|NCT00264381|Primary|Thrombosis Progression or Venous Thromboembolism (VTE) at 3 Months|Symptomatic thrombosis extension (DVT) or pulmonary embolism at 3 months documented by radiologic testing.|3 months|Participants available for follow up||participants|||Number
715835|NCT00264381|Primary|Thrombosis Progression and Venous Thromboembolism (VTE)|Thrombosis progression and deep vein thrombosis at day 14 by ultrasound testing|Day 14|Total number available for follow up||participants|||Number
715836|NCT00264381|Secondary|Major and Minor Bleeding Secondary to Dalteparin and Ibuprofen Treatment During the 3 Month Follow up.|Number of participants with bleeding events related to treatment|3 months|||participants|||Number
715837|NCT00264498|Primary|Progression Free Survival (PFS)|Interval between date of randomization and earliest date of objective disease progression per RECIST criteria or death due to any cause in the absence of progression|Date of randomization to earliest date of objective disease progression|||Days||95% Confidence Interval|Mean
715838|NCT00264537|Secondary|Change From Baseline in Total Van Der Heijde Modified Sharp (vdH-S) Score at Week 52 in Patients With Abnormal C-reactive Protein (CRP Greater Than 1.0 mg/dL) at Baseline|The vdH-S score is the sum of the joint erosion score and the joint-space narrowing (JSN) score. The total score ranges from 0 (best) to 448 (worst) with higher scores indicating more joint damage.|Baseline and Week 52|All participants randomly assigned to each treatment group who had C-reactive protein > 1.0 mg/dl at baseline.||Scores on a scale||Standard Deviation|Mean
715839|NCT00264537|Primary|Change From Baseline in Total Van Der Heijde Modified Sharp (vdH-S) Score at Week 52|The vdH-S score is the sum of the joint erosion score and the joint-space narrowing (JSN) score. The total score ranges from 0 (best) to 448 (worst) with higher scores indicating more joint damage.|Baseline and Week 52|All participants randomly assigned to each treatment group.||Scores on a scale||Standard Deviation|Mean
715840|NCT00264537|Secondary|Number of Patients With Abnormal Baseline C-reactive Protein (CRP) Who Achieved American College of Rheumatology (ACR) 50 Response at Week 24|ACR 50 response is defined as a greater than or equal to 50 percent improvement from baseline in: 1. Swollen joint count (66 joints) and tender joint count (68 joints) 2. greater than or equal to 50 percentage improvement in 3 of the following 5 assessments: a. Patient's assessment of pain by the Visual Analogue Scale (VAS) (0-10 cm) b.Patient's Global Assessment of Disease activity VAS (0-10 cm) c. Physician's Global Assessment of Disease Activity VAS (0-10 cm) d. Patient's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C reactive protein.|Week 24|Randomized participants with abnormal baseline CRP. Participants considered non-responders if used any prohibited medications or discontinued subcutaneous study agent due to lack of efficacy. Missing ACR components imputed by Last Observation Carried Forward unless all ACR components were missing; in which case considered non-responders.||Participants|||Number
715841|NCT00264537|Secondary|Number of Participants Who Achieved American College of Rheumatology (ACR) 20 Response at Week 24|ACR 20 response is defined as a greater than or equal to 20 percent improvement from baseline in: 1. Swollen joint count (66 joints) and tender joint count (68 joints) 2. greater than or equal to 20 percentage improvement in 3 of the following 5 assessments: a. Patient's assessment of pain by the Visual Analogue Scale (VAS) (0-10 cm) b.Patient's Global Assessment of Disease activity VAS (0-10 cm) c. Physician's Global Assessment of Disease Activity VAS (0-10 cm) d. Patient's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C reactive protein.|Week 24|All participants randomly assigned to each treatment group. Participants considered non-responders if used any prohibited medications or discontinued subcutaneous study agent due to lack of efficacy. Missing ACR components imputed by Last Observation Carried Forward unless all ACR components were missing; in which case considered non-responders.||Participants|||Number
715842|NCT00264537|Primary|Number of Participants Who Achieved American College of Rheumatology (ACR) 50 Response at Week 24|ACR 50 response is defined as a greater than or equal to 50 percent improvement from baseline in: 1. Swollen joint count (66 joints) and tender joint count (68 joints) 2. greater than or equal to 50 percentage improvement in 3 of the following 5 assessments: a. Patient's assessment of pain by the Visual Analogue Scale (VAS) (0-10 cm) b.Patient's Global Assessment of Disease activity VAS (0-10 cm) c. Physician's Global Assessment of Disease Activity VAS (0-10 cm) d. Patient's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C reactive protein.|Week 24|All participants randomly assigned to each treatment group. Participants considered non-responders if used any prohibited medications or discontinued subcutaneous study agent due to lack of efficacy. Missing ACR components imputed by Last Observation Carried Forward unless all ACR components were missing; in which case considered non-responders.||Participants|||Number
715843|NCT00264550|Secondary|Change From Baseline in Total Van Der Heijde Modified Sharp (vdH-S) Score at Week 24|The vdH-S score is the sum of joint erosion score and joint-space narrowing (JSN) score. The total score ranges from 0 (best) to 448 (worst) with higher scores indicating more joint damage.|Baseline (Week 0) and Week 24|All participants randomly assigned to each treatment group||Units on a scale||Inter-Quartile Range|Median
715844|NCT00264550|Secondary|Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Week 14|The HAQ is 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0 (no difficulty), to 3 (inability to perform a task in that area). The average score across the functional areas yields an overall HAQ score which ranges from 0 (no disability) to 3 (completely disabled).|Baseline (Week 0) and Week 14|All participants randomly assigned to each treatment group||Units on a scale||Inter-Quartile Range|Median
715845|NCT00264550|Secondary|Number of Participants Who Achieved American College of Rheumatology 20 (ACR 20) Response at Week 24|An ACR 20 response is defined as a greater than or equal to 20 percent improvement from baseline in: 1. Swollen joint count (66 joints) and tender joint count (68 joints) 2. greater than or equal to 50 percentage improvement in 3 of the following 5 assessments: a. Patient's assessment of pain (VAS) (0-10 cm) b.Patient's Global Assessment of Disease activity (VAS) (0-10 cm) c. Physician's Global Assessment of Disease Activity (VAS) (0-10 cm) d. Patient's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C reactive protein (CRP).|Week 24|All participants randomly assigned to each treatment group||Participants|||Number
715846|NCT00264550|Primary|Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Week 24|HAQ is 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0 (no difficulty), to 3 (inability to perform a task in that area). The average score across the functional areas yields an overall HAQ score which ranges from 0 (no disability) to 3 (completely disabled).|Baseline (Week 0) and Week 24|All participants randomly assigned to each treatment group||Units on a scale||Inter-Quartile Range|Median
715847|NCT00264550|Secondary|Number of Participants With Disease Activity Index Score 28 (DAS 28) Using C-reactive Protein (CRP) Response at Week 14|DAS 28 using CRP is an index to measure the disease activity in participants with rheumatoid arthritis which combines tender joint count (28 joints), swollen joint count (28 joints), CRP value, and participant’s global assessment of disease activity (using a Visual Analog Scale of 0 to 100 mm). The DAS 28 score ranges from 0 (best) to 10 (worst). Participants are considered to have a DAS 28 response if they have a score of <= 3.2 (good response) or > 3.2 to 5.1 (moderate response).|Week 14|All participants randomly assigned to each treatment group||Participants|||Number
715880|NCT00264875|Primary|Mean Visual Analogue Scale (VAS) Pain Scores|"Pain scores were assessed on a 100 mm Visual Analogue Scale (VAS); scores range from 0= no pain to 100= worse pain. Subjects assessed their pain during the last week.
Endpoint = last non-missing observation carried forward after Baseline visit."|Baseline, Week 4, Week 8, Week 12, and Endpoint|The full analysis set was defined as all subjects who met all eligibility criteria and took at least one dose of study medication.||score on scale||Standard Deviation|Mean
715848|NCT00264550|Primary|Number of Participants Who Achieved American College of Rheumatology (ACR) 20 Response at Week 14|ACR 20 response is defined as a greater than or equal to 20 percent improvement from baseline in: 1. Swollen joint count (66 joints) and tender joint count (68 joints) 2. greater than or equal to 50 percentage improvement in 3 of the following 5 assessments: a. Patient's assessment of pain of pain by the Visual Analogue Scale (VAS) (0-10 cm) b.Patient's Global Assessment of Disease activity VAS (0-10 cm) c. Physician's Global Assessment of Disease Activity VAS (0-10 cm) d. Patient's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C reactive protein.|Week 14|All participants randomly assigned to each treatment group||Participants|||Number
715849|NCT00264576|Secondary|Number of Subjects Reporting Local and Systemic Reactions|"Safety and tolerability of cTIV and eTIV_f postvaccination.
Difference between demography and safety numbers was due to one misrandomization."|7 days postvaccination|Analysis was done on safety set||Subjects|||Number
715850|NCT00264576|Primary|Geometric Mean Titers (GMT) After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANCOVA Method.|Non-inferiority was measured by the ratio of postvaccination geometric mean titers (cTIV vs. eTIV_f) against all three vaccine strains as assessed by egg-derived antigen and cell-derived antigen haemagglutination inhibition (HI) assay.|3 weeks postvaccination (Day 22)|Analysis was done on per protocol set||Titer||95% Confidence Interval|Geometric Mean
715851|NCT00264576|Secondary|Percentages of Subjects With Seroconversion.|As the definition for seroconversion/significant increase from CHMP guideline CPMP/BWP/214/96 corresponds to that of seroconversion from the May 2007 CBER guidance, the analysis of this immunogenicity endpoint is presented as seroconversion. Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40, or prevaccination HI titer ≥10 and a ≥4-fold increase in postvaccination HI antibody titer, on day 22. CBER criterion is met if the lower limit of the 95% CI for percentages of subjects achieving seroconversion for HI antibody (at least a 4-fold rise in HI antibody titer) postvaccination is ≥40%. CHMP criterion is also met if the percentages of subjects achieving seroconversion is >40%.|3 weeks postvaccination (Day 22)|Analysis was done on per protocol set||Percentages||95% Confidence Interval|Number
715852|NCT00264576|Secondary|Percentages of Subjects With Haemagglutination Inhibition (HI) Antibody Titer ≥ 40.|"Antibody titers as assessed by egg-derived antigen and cell-derived antigen HI assay.
This criterion is met according to European (CHMP) guideline if the percentages of subjects achieving HI titers ≥40 is >70%. According to the US Center for Biologics Evaluation and Research (CBER) guideline, the criterion is also met if the lower limit of the 95% CI for percentages of subjects achieving seroprotection (HI antibody titer ≥1:40) is ≥70%."|3 weeks postvaccination (Day 22)|Analysis was done on per protocol set||Percentages||95% Confidence Interval|Number
715853|NCT00264576|Secondary|Geometric Mean Titers (GMT) Before and After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method|Antibody titers as assessed by egg-derived antigen and cell-derived antigen haemagglutination inhibition (HI) assay.|3 weeks postvaccination (Day 22)|Analysis was done on per protocol set||Titer||95% Confidence Interval|Geometric Mean
715854|NCT00264576|Secondary|Geometric Mean Ratio After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANCOVA Method.|"Geometric mean ratio (GMR) of Day 22 / Day 1 geometric mean antibody titers was assessed by egg-derived antigen and cell-derived antigen haemagglutination inhibition (HI) assay.
The criterion is met according to European (CHMP) guideline if the mean geometric increase GMR (Day22/Day1) in HI antibody titer is > 2.5."|3 weeks postvaccination (Day 22)|Analysis was done on per protocol set||Ratio||95% Confidence Interval|Geometric Mean
715855|NCT00264576|Secondary|Geometric Mean Ratio After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method.|"Geometric mean ratio (GMR) of Day 22 / Day 1 geometric mean antibody titers was assessed by egg-derived antigen and cell-derived antigen haemagglutination inhibition (HI) assay.
The criterion is met according to European (CHMP) guideline if the mean geometric increase GMR (Day22/Day1) in HI antibody titer is > 2.5."|3 weeks postvaccination (Day 22)|Analysis was done on per protocol set||Ratio||95% Confidence Interval|Geometric Mean
715856|NCT00264576|Primary|Geometric Mean Titers (GMT) After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method.|Non-inferiority was measured by the ratio of postvaccination geometric mean titers (cTIV vs. eTIV_f) against all three vaccine strains as assessed by egg-derived antigen and cell-derived antigen haemagglutination inhibition (HI) assay.|3 weeks postvaccination (Day 22)|Analysis was done on per protocol set||Titer||95% Confidence Interval|Geometric Mean
715857|NCT00264641|Primary|Cerebral Activation During Hypoglycaemia|To compare the high RAS activity vs low RAS activity a Z score was used.|After 4 scans on day 1|Only data available is between group analysis||Z score|||Number
715858|NCT00264797|Secondary|Substance Use Outcomes|The mean number of negative urine drug screens (UDS).|20 weeks|All randomized participants.||negative UDS||Standard Deviation|Mean
715859|NCT00264797|Secondary|OROS-MPH Abuse Liability|Assessed by pill counts in conjunction with weekly review of subjects' medication diaries and self-reported medication compliance.|20 weeks|All randomized participants.||pills||Standard Deviation|Mean
715860|NCT00264797|Primary|Substance Use|The change in number of days of substance use from baseline to end of the trial. The number of days of non-tobacco drug/alcohol ascertained using standard timeline follow back (TLFB) procedures.|20 weeks|All randomized participants.||days||95% Confidence Interval|Mean
715861|NCT00264797|Primary|ADHD Severity|DSM IV ADHD Rating Scale (ADHD-RS) adolescent informant, ascertained at baseline and weekly throughout the 16 week study. This scale is an 18-item symptom checklist of self-reported adolescent ADHD symptoms. Symptoms are scored as None (0), Mild (1), Moderate (2), and Severe (3), with a summary total of scores for the 18 symptoms. Possible scores range from 0 to 54, with higher scores indicating greater severity. Outcome is measured as the decrease in total severity score over time.|baseline and 20 weeks|All randomized participants.||units on a scale||Standard Deviation|Mean
715919|NCT00265317|Secondary|PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms|PFS, defined as time from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in subgroups that were defined by PDGFRB polymorphisms. PFS was calculated as (first event date minus randomization date plus 1) divided by 7.02.|From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)|Per Protocol Caucasian Population||Weeks||95% Confidence Interval|Median
715862|NCT00264810|Primary|Change in Frequency of Disabling Seizures|"The outcome measure is met when a significantly greater reduction in the frequency of total disabling seizures in seen in the Treatment group when compared to the Sham group, during the Blinded Evaluation Period (BEP) relative to the Pre-Implant Period (Baseline).
The outcome measure is the group-by-time interaction term in a generalized estimating equation (GEE), longitudinal regression model, where group refers to therapy allocation (Treatment or Sham), time refers to study period (Baseline or BEP), and the dependent variable is seizure frequency. The outcome measure was a statistically significant group-by-time interaction term, which would demonstrate a significantly greater reduction in seizure frequency in the Treatment group than the Sham group during BEP compared to Baseline Period.
Primary Effectiveness Outcome Measure was met.
(Note: Disabling seizures = motor simple partial seizures or complex partial seizures with or without secondarily generalized seizures.)"|3 months pre-implant (Baseline Period) compared to months 3, 4 and 5 post-implant (Blinded Evaluation Period)|||Seizure frequency % change from Baseline||95% Confidence Interval|Number
715863|NCT00264810|Primary|Short-term Chronic SAE Rate|"RNS® System Short-term Chronic SAE rate = the percentage of implanted subject having a serious adverse event (SAE) for the surgical implant procedure and the following 3 months (84 days), whether reported as device-related or not.
This outcome measure is met when the upper limit of one-sided 95% confidence interval of the observed RNS® System Short-term Chronic SAE Rate does not exceed the upper limit of the one-sided 95% confidence interval of the historical short-term chronic SAE rate for deep brain stimulation for movement disorders from the published literature (rate = 36%; upper CI = 42%). The comparator was calculated based upon the literature, therefore the number of participants analyzed is unknown/not applicable. Referenced literature are listed within the citation section (Oh et al., 2002; SSED, Activa Tremor Control System P960009; Beric et al., 2001; Behrens et al., 1997; Hariz, 2002; Joint et al., 2002; Koller et al., 2001).
Primary Safety Outcome Measure was met."|Initial implant through 5 months post-implant|||percentage of subjects with ≥ 1 SAE||95% Confidence Interval|Number
715864|NCT00264810|Primary|Acute SAE Rate|"RNS® System Acute SAE Rate = the percentage of implanted subject having a serious adverse event (SAE) for the surgical implant procedure and the following month (28 days), whether reported as device-related or not.
This outcome measure is met when the upper limit of one-sided 95% confidence interval of the observed RNS® System Acute SAE Rate does not exceed the upper limit of the one-sided 95% confidence interval of the literature-based acute SAE rate associated with the implantation of intracranial electrodes for localization procedures and epilepsy surgery combined as documented in the literature (rate = 15%; upper CI = 20%). The comparator was calculated based upon the literature, therefore the number of participants analyzed is unknown/not applicable. Referenced literature are listed within the citation section (Tanriverdi et al., 2009; Wong et al., 2009; Fountas and Smith, 2007; Hamer et al., 2002; Behrens et al., 1997).
Primary Safety Outcome Measure was met."|Initial implant through 1 month post-implant|||percentage of subjects with ≥ 1 SAE||95% Confidence Interval|Number
715865|NCT00264849|Secondary|Changes From Baseline to Week 31 in the Percent Activity Impairment Due to Asthma Problems|The Work Productivity and Activity Impairment - Allergic Asthma (WPAI-AA) questionnaire measures time missed from work, impairment of work and regular activities within the last 7 days. Questionnaires were administered via phone 1 week prior to the study visit. Outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity. Activity impairment due to asthma problems is derived from the patients assessment of the degree to which asthma problems affected regular activities. A negative change from baseline indicates improvement.|Baseline and Week 31|Modified Intent-to-Treat. Only patients with a value at both baseline and Week 31 visit were included. Sensitivity analysis excluded questionnaires which were answered after the clinic visit.||percent impairment||Standard Deviation|Mean
715866|NCT00264849|Secondary|Changes From Baseline to Week 31 in the Percent Overall Work Impairment Due to Asthma Problems|The Work Productivity and Activity Impairment-Allergic Asthma (WPAI-AA) questionnaire measures time missed from work, impairment of work and regular activities within the last 7 days. Questionnaires were administered via phone 1 week prior to the study visit. Outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity. Overall work impairment due to asthma problems is derived from the proportion of hours missed from work due to asthma and the degree to which asthma problems affected productivity while working.|Baseline and Week 31|Modified Intent-to-Treat. Only patients only who worked and with values at both baseline and Week 31 visit were included. Sensitivity analysis excluded questionnaires which were answered after the clinic visit.||percent impairment||Standard Deviation|Mean
715867|NCT00264849|Secondary|Change From Baseline in EuroQual 5-Dimension Health Status Questionnaire (EQ-5D) Index Score and Health State Assessment on Scale From 0 to 100 at Weeks 15 and 31|"The utility-based EQ-5D questionnaire is in two parts and provides a generic measure of health for clinical and economic appraisal. The first health state classification part has 5 questions each with 3 categories (no problem, moderate problem, severe problems). The second visual analogue scale was measured from 0 (worst imaginable health state) to 100 (best imaginable health state)."|Baseline, Week 15, Week 31|Modified Intent-to-Treat with N count as noted in category description.||units on a scale||95% Confidence Interval|Least Squares Mean
715868|NCT00264849|Secondary|Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Overall Score by Visit|There are 32 questions in the AQLQ and they are in 4 domains (symptoms, activity limitation, emotional function and environmental exposure). Each question was answered on a 7 point scale (1–totally limited/problems all the time, 7–not at all limited/no problems). The overall AQLQ score is the mean of all 32 responses, and the individual domain scores are the means of the items in those domains (a minimum domain / overall score of 1 = Severely impaired whereas a maximum domain / overall score of 7 = not impaired at all). A positive change from baseline score indicates improvement.|Baseline, Week 15, Week 31|mITT at Week 15 for OAT + Omalizumab is 214 patients and for OAT is 92 patients; at Week 31 for OAT + Omalizumab is 224 patients and for OAT is 97 patients except as noted in the category description. To be included in this table patients must have a AQLQ measurement for the specified timepoint.||units on a scale||95% Confidence Interval|Least Squares Mean
715869|NCT00264849|Secondary|Number of Participants by Type of Dose Change of Maintenance Systemic Steroids at Weeks 16 and 32|The type of change for the dose of maintenance systemic steroids could be presented as removal (no more maintenance systemic steroids used), decreased, or maintained.|Weeks 16 and 32|mITT patients with systemic steroids at baseline (defined as those patient who used systemic steroids throughout the entire run-in period from Visit 1 to Visit 6).||participants|||Number
715870|NCT00264849|Secondary|Percent Change in Dose of Maintenance Systemic Steroids at Weeks 16 and 32|For the subgroup of patients requiring maintenance oral (systemic) corticosteroids throughout the screening period the dose of oral steroid (expressed as prednisolone equivalent dose) at baseline, Week 16 and Week 32 was presented by treatment group, as well as the absolute and percent change from baseline to Weeks 16 and 32. It should be noted that the dose of oral steroid at Weeks 16 and 32 was the dose the patient was maintained on and not the dose to treat an exacerbation if one occurred at that time.|Weeks 16 and 32|mITT patients with systemic steriods at baseline (defined as those patient who used systemic steroids throughout the entire run-in period from Visit 1 to Visit 6). N counts as noted in the category description.||percent change||Standard Deviation|Mean
715871|NCT00264849|Secondary|Medical Resource Utilization: Number of Participants With Combined Hospital Admissions, Emergency Room Visits, and Other Outpatient Clinical Visits Due to an Asthma Exacerbation During the 32 Week Treatment Period|A combined total of unscheduled visits due to asthma exacerbations was calculated for each patient as the total number of hospital admissions, ER visits and unscheduled outpatient clinical visits due to asthma exacerbation. Where more than one type of visit was required on a single day for an asthma exacerbation only the most serious type was included. Where there was more than one visit for a single asthma exacerbation but the visits occurred on different dates, then all were counted.|32 Weeks|Modified Intent-to-Treat (mITT)||participants|||Number
715872|NCT00264849|Secondary|Number Participants With Clinically Significant Asthma Exacerbations by Category During the 32 Week Treatment Period|A clinically significant exacerbation episode was defined as a worsening of asthma requiring treatment with rescue systemic (oral or IV) corticosteroids. The initiation of the rescue systemic corticosteroids marked the start of a clinically significant asthma exacerbation episode and cessation of the rescue systemic corticosteroids regimen marked the end of a clinically significant exacerbation episode. If an exacerbation episode was duplicated, overlapped by at least one day with another episode, or nested within another exacerbation episode, only one exacerbation was counted.|32 Weeks|mITT||participants|||Number
715873|NCT00264849|Secondary|Change From Baseline in Asthma Control Questionnaire (ACQ) Overall Score at Weeks 16 and 32|Asthma symptoms were evaluated by the Asthma Control Questionnaire (ACQ). The ACQ has six questions to be answered by the patient, each with a 7 point scale (0–good control, 6–poor control), and one question where the actual pre-bronchodilator FEV1 value expressed in % of predicted FEV1 was classified to scores from 0 (> 95% of predicted) to 6 (< 50% of predicted). The overall score is the average of the 7 questions; a minimum overall score of 0 = good control of asthma whereas a maximum overall score of 6 = poor control of asthma. A negative change in score indicates improvement in symptoms.|Baseline, Week 16, Week 32|mITT with N counts as noted in the category description. To be included in this table patients must have a ACQ measurement for the specified timepoint.||units on a scale||95% Confidence Interval|Least Squares Mean
715874|NCT00264849|Secondary|Lung Function Assessed by Forced Expiratory Volume for 1 Second (FEV1)|Predicted FEV1 was calculated using the Crapo formula for data at Visit 6 (time of randomization), (MALES: Predicted FEV1 (L) = 0.0414*height - 0.0244*age -2.190 and Females: Predicted FEV1 (L) = 0.0342*height - 0.0255*age - 1.578, where height is in cm).|Weeks 16 and 32|Modified Intent-to-Treat (mITT), for Week 16 N=258/106 for OAT+Omalizumab/OAT and for Week 32 N=266/121 for OAT+Omalizumab/OAT, respectively.||percent predicted FEV1||95% Confidence Interval|Least Squares Mean
715875|NCT00264849|Secondary|Percentage of Participants Who Were Responders at Both Week 16 and Week 32 Based on Patient's GETE|Responders were defined as excellent or good based on the patient's Global Evaluation of Treatment Effectiveness (GETE) for patients receiving omalizumab as add on to optimal asthma therapy, assessed at week 16 and week 32.|Weeks 16 and 32|mITT population and patients who were assessed for persistency of response or non-response at Week 16 and had a GETE obtained >= 4 weeks after the Week 16 assessment or discontinued prematurely or unsatisfactory therapeutic effect >= 4 weeks after the Week 16 assessment. N=187/28 for OAT+Omalizumab/OAT for responders and N=71/63 for non-responders.||percentage of participants||95% Confidence Interval|Number
715876|NCT00264849|Secondary|Number of Participants by Patient's Global Evaluation of Treatment Effectiveness (GETE) Category at Week 16 and 32|Number of participants with persistent response, based on the patient's GETE, dichotomized to responders (excellent or good) and non-responders (moderate, poor or worsening) for patients receiving omalizumab as add on to optimal asthma therapy, assessed at week 16 and week 32. Persistency was defined as the proportion of responders at 16 weeks who were still responders at 32 weeks.|Weeks 16 and 32|Modified Intent-to-Treat (mITT)||participants|||Number
715877|NCT00264849|Secondary|Percentage of Participants Who Were Responders at Both Week 16 and Week 32 Based on Investigator's GETE|Responders were defined as excellent or good based on the investigator's Global Evaluation of Treatment Effectiveness (GETE) for patients receiving omalizumab as add on to optimal asthma therapy, assessed at week 16 and week 32.|Weeks 16 and 32|Modified Intent-to-Treat (mITT)||percentage of participants||95% Confidence Interval|Number
715878|NCT00264849|Secondary|Number of Participants by Investigator's Global Evaluation of Treatment Effectiveness (GETE) Category at Week 16 and Week 32|Number of participants with persistent response, based on the investigator’s GETE, dichotomized to responders (excellent or good) and non-responders (moderate, poor or worsening) for patients receiving omalizumab as add on to optimal asthma therapy, assessed at week 16 and week 32. Persistency was defined as the proportion of responders at 16 weeks who were still responders at 32 weeks. GETE categories are excellent, good, moderate, poor, worsening, and missing as determined by the investigator.|Weeks 16 and 32|Modified Intent-to-Treat (mITT)||participants|||Number
715879|NCT00264849|Primary|Persistency of Response and Non-response as Based on Investigator's Global Evaluation of Treatment Effectiveness (GETE)|Persistency of response, based on GETE, was dichotomized into responders (excellent or good) and non-responders (moderate, poor or worsening). Persistent responders were patients who were responders at 16 weeks and still at 32 weeks. Persistent non-responders were patients who were non-responders at 16 weeks and still at 32 weeks. Patients were assessed for persistency of response if they were responders at Week 16 and had a second GETE obtained ≥ 4 weeks after the Week 16 assessment or discontinued prematurely for unsatisfactory therapeutic effect ≥ 4 weeks after the Week 16 assessment.|Weeks 16 and 32|Modified Intent-to-Treat (mITT) was defined for efficacy analyses which included all randomized patients who had at least one post-baseline efficacy assessment.||participants|||Number
715977|NCT00265330|Primary|Mean Change From Baseline in Standing Diastolic Blood Pressure|Mean Change: vital sign value at observation minus vital sign value at baseline|Week 1 through Week 26|||mm Hg||Standard Deviation|Mean
715881|NCT00265083|Secondary|Summary of Change From Baseline in Bath Ankylosing Spondylitis Metrology Index at Week 14|The Bath Ankylosing Spondylitis Metrology Index (BASMI) is the sum of scores comprised of 5 measures (0=mild, 1=moderate & 2=severe): Tragus-to-wall; Lumbar flexion; Cervical rotation; Lumbar side flexion; Intermalleolar distance. BASMI ranges from 0 to 10. Change from baseline is Wk 14 value minus baseline value.|From Baseline to Week 14|Intent to treat (ITT). Patients considered non-change from baseline in BASMI if used any pre-specified prohibited medications or discontinued SC study agent due to lack of efficacy. Missing value of change from baseline in BASMI at Week 14 was imputed by Last Observation Carried Forward (LOCF).||Change from baseline in BASMI Index||Standard Deviation|Mean
715882|NCT00265083|Secondary|Summary of Change From Baseline in Bath Ankylosing Spondylitis Functional Index at Week 14|The Bath Ankylosing Spondylitis Functional Index (BASFI) is calculated as the mean of 10 VAS, each of length 0 to 10 cm. Eight of the scales relate to functional capacity of patients while the other 2 relate to a patient’s ability to cope with everyday life. Change from baseline is Wk 14 value minus baseline value.|From Baseline to Week 14|Intent to treat (ITT). Patients considered non-change from baseline in BASFI if used any pre-specified prohibited medications or discontinued SC study agent due to lack of efficacy. Missing value of change from baseline in BASFI at Week 14 was imputed by Last Observation Carried Forward (LOCF).||Change from baseline in BASFI Index||Inter-Quartile Range|Median
715883|NCT00265083|Secondary|Assessment in Ankylosing Spondylitis 20 Responders at Week 24|Number of patients who achieved a 20% improvement and at least 1 absolute improvement on a 0 to 10 cm scale from baseline to Week 24 at least 3 of the 4 domains: patient global, total back pain, function or inflammation.|Week 24|ITT. Patients (pts) considered non-responder if used any pre-specified prohibited medications or discontinued SC study agent due to lack of efficacy. Missing ASAS components were imputed by LOCF unless all ASAS components are missing in which case considered non-responders. Wk 16 ASAS response was used for pts with change in study treatment.||P a r t i c ip an t s|||Number
715884|NCT00265083|Primary|Assessment in Ankylosing Spondylitis 20 Responders at Week 14|Number of patients who achieved a 20% improvement and at least 1 absolute improvement on a 0 to 10 cm scale from baseline to Week 14 in at least 3 of the 4 domains: patient global, total back pain, function or inflammation.|Week 14|Intent to treat (ITT). Patients considered non-responder if used any pre-specified prohibited medications or discontinued subcutaneous (SC) study agent due to lack of efficacy. Missing ASAS components at Week 14 were imputed by Last Observation Carried Forward (LOCF) unless all ASAS components are missing in which case considered non-responders.||Participants|||Number
715885|NCT00265096|Secondary|American College of Rheumatology 20 at Week 24|"Number of Patients who achieved an American College of Rheumatology (ACR) 20 response at Week (Wk) 24.
ACR 20 response is an improvement of >= 20% from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (Patient's assessment of pain, Patient's global assessment of disease activity, Physician's global assessment of disease activity Visual Analogue Scale [VAS], Health Assessment Questionnaire [HAQ] and C-reactive protein [CRP])"|Baseline, Week 4, Week 8, Week 14, Week 16, Week 20 and Week 24|ITT. Patients considered non-responder if used any pre-specified prohibited medications or discontinued SC study agent due to lack of efficacy. Missing ACR components were imputed by LOCF unless all ACR components are missing in which case considered non-responders. Wk 16 ACR response was used for patients with change in study treatment.||P a r t i c ip an t s|||Number
715886|NCT00265096|Primary|Change From Baseline in Total Radiographic Scores of the Hands and Feet at Week 24|Summary of change from baseline in total van der Heijde-Sharp (vdH-S) score of the hands and feet, as modified for psoriatic arthritis, at Week 24. The vdH-S score is the sum of joint erosion score and joint-space narrowing (JSN) score. The total score ranges from 0 to 528 with higher scores indicating more joint damage. For the change from baseline, positive values show an increase in damage.|Baseline and Week 24|Intent-to-treat analysis.||Scores on a scale||Standard Deviation|Mean
715887|NCT00265096|Secondary|Change From Baseline in the Physical Component Summary Score of the 36-item Short Form Health Survey at Week 14|The short form health survey (SF-36) is a well-validated and widely used quality-of-life instrument employed in numerous disease states. It is a self-administered survey that measures eight domains of health including: physical functioning, role limitations due to physical health (role-physical), bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems (role-emotional) and general mental health. Scoring of the SF-36 was based on the SF-36 Manual and Interpretation Guide. Worst value is 0 and best value is 100.|Baseline and Week 14|Intention to treat (ITT). Missing scores were imputed by Last Observation Carried Forward (LOCF).||scores on a scale||Standard Deviation|Mean
715888|NCT00265096|Secondary|Improvement From Baseline in Health Assessment Questionnaire Scores at Week 24|Summary of improvement from baseline in Health Assessment Questionnaire (HAQ) score at Week (Wk) 24. This 20-question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area based on the worst score from the questions that pertain to that task. The HAQ score is determined by the average of the 8 scores.|Baseline, Week 4, Week 8, Week 14, Week 16, Week 20 and Week 24|Intention to treat (ITT). Missing scores were imputed by LOCF. Week (Wk) 16 scores were used for patients with change in study treatment. Week 16 HAQ scores were used for patients with change in study treatment.||scores on a scale||Inter-Quartile Range|Median
715889|NCT00265096|Secondary|Psoriasis Area and Severity Index (PASI) 75 Response at Week 14 in a Subset of Patients With ≥ 3 Percent Body Surface Area (BSA) Psoriasis Skin Involvement at Baseline|Number of patients (randomized patients with >= 3 percent Body Surface Area [BSA] psoriasis skin involvement at baseline) with Psoriasis Area and Severity Index (PASI) 75 response at Week 14. PASI is the widely used tool for the measurement of severity of psoriasis. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range of 0 to 72. Zero (0) means no disease and 72 means maximal disease. PASI 75 Response at Week 14 means reduction in PASI score by 75 percent at Week 14.|Baseline, Week 4, Week 8 and Week 14|In a subset of patients with ≥ 3 percent body surface area (BSA) psoriasis skin involvement at baseline. Missing scores were imputed by Last Observation Carried Forward (LOCF).||Participants|||Number
715978|NCT00265330|Primary|Mean Change From Baseline in Standing Systolic Blood Pressure|Mean Change: vital sign value at observation minus vital sign value at baseline|Week 1 through Week 26|||mm Hg||Standard Deviation|Mean
715890|NCT00265096|Primary|American College of Rheumatology (ACR) 20 Response at Week 14|ACR 20 response is an improvement of >= 20% from baseline (baseline measurement is defined as the closest measurement taken prior to or at the time of the initiation of study medication administration) in both the tender and swollen joint count and in at least 3 of the 5 assessments (Patient's assessment of pain, Patient's global assessment of disease activity, Physician's global assessment of disease activity Visual Analogue Scale [VAS], Health Assessment Questionnaire [HAQ] and C-reactive protein [CRP])|Baseline (Week 0), Week 4, Week 8 and Week 14|Intention to treat (ITT). Patients considered non-responder if used any pre-specified prohibited medications or discontinued subcutaneous (SC) study agent due to lack of efficacy. Missing ACR components at Week 14 were imputed by Last Observation Carried Forward (LOCF) unless all ACR components are missing in which case considered non-responders.||Participants|||Number
715891|NCT00265109|Secondary|Body Dysmorphic Disorder Clinical Global Impressions Scale; Hamilton Rating Scale for Depression; Quality of Life Enjoyment and Satisfaction Questionnaire; Social Phobia Inventory; Beck Anxiety Inventory;||Past week||||||
715892|NCT00265109|Primary|Number of Responders on the Yale-Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder (BDD-YBOCS)|The BDD-YBOCS, a reliable and valid 12-item semi-structured clinician-administered scale assessed BDD severity during the past week. 38 items are rated from 0 (no symptoms) to 4 (extreme symptoms); range=0–48. This scale assesses preoccupation with the perceived appearance defects, associated compulsive behaviors, insight, and avoidance. A ≥30% decrease in total score indicated response.|Baseline to end week 12|Analyses of the primary outcome measure were intention to treat (ITT) analyses.||Participants|||Number
715893|NCT00265122|Secondary|Number of Participants in Population 1 With Clinical Remission at Week 8|The table below shows the number of participants in Population 1 with clinical remission at Week 8 defined a CDAI (Crohn's disease activity index) score < 150 points at Week 8. A reduction in CDAI score correlates with improvement in the severity of illness. The CDAI is derived as a weighted sum of 8 different Crohn’s disease related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools (or bags emptied for participants with a stoma), abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being.|Week 8|The analysis included all randomized patients (ITT), regardless of whether they had any protocol deviations.||participants|||Number
715894|NCT00265122|Secondary|Number of Participants in Population 2 With a Clinical Response at Week 8|The table below provides the number of participants in Population 2 with a clinical response at Week 8 defined as a reduction from baseline in the CDAI (Crohn's disease activity index) score of >= 25% and >= 70 points at Week 8. A reduction in CDAI score correlates with improvement in the severity of illness. The CDAI is derived as a weighted sum of 8 different Crohn’s disease related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools (or bags emptied for participants with a stoma), abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being.|Week 8|The analysis included all randomized patients (ITT), regardless of whether they had any protocol deviations.||participants|||Number
715895|NCT00265122|Primary|Number of Participants in Population 1 With a Clinical Response at Week 8|The table below provides the number of participants in Population 1 with a clinical response at Week 8 defined as a reduction from baseline in the CDAI (Crohn's disease activity index) score of >= 25% and >= 70 points at Week 8. A reduction in CDAI score correlates with improvement in the severity of illness. The CDAI is derived as a weighted sum of 8 different Crohn’s disease related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools (or bags emptied for participants with a stoma), abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well being. The primary endpoint analysis was based on the comparison between the combined SC and IV Placebo and combined SC and IV ustekinumab treatment groups in Population 1.|Week 8|The analysis included all randomized patients (ITT), regardless of whether they had any protocol deviations.||participants|||Number
715896|NCT00265200|Primary|Average Percent Change From Baseline in TRAP Levels at 2 Weeks|Change was calculated as 100% (value at baseline minus value at 2 weeks)/value at baseline|TRAP levels at Baseline and 2 weeks after first Zometa infusion|13 of 28 total study participants could not be evaluated: 7 due to sample deterioration; 5 participant non-compliance; 1 withdrew.||Percent change||Full Range|Mean
715897|NCT00265239|Primary|Nonfatal Ischemic Stroke|number of nonfatal ischemic stroke|415days|||events|||Number
715898|NCT00265239|Primary|Refractory Angina Pectoris|number of refractory angina pectoris|415days|||events|||Number
715899|NCT00265239|Primary|Nonfatal Myocardial Reinfarction|number of nonfatal myocardial reinfarction|415days|||events|||Number
715900|NCT00265239|Primary|Cardiac Death|number of cardiac death|415±32 days|||events|||Number
715901|NCT00265317|Secondary|Plasma Concentration of Soluble KIT (sKIT) at Baseline||Baseline (Cycle 1, Day 1)|FA Set||pg/mL||Full Range|Median
715902|NCT00265317|Secondary|Plasma Concentration of Soluble VEGFR-3 at Baseline||Baseline (Cycle 1, Day 1)|FA Set||pg/mL||Full Range|Median
715903|NCT00265317|Secondary|Plasma Concentration of Soluble VEGFR-2 at Baseline||Baseline (Cycle 1, Day 1)|FA Set||pg/mL||Full Range|Median
715904|NCT00265317|Secondary|Plasma Concentration of VEGF-C at Baseline||Baseline (Cycle 1, Day 1)|FA Set||picograms (pg)/mL||Full Range|Median
715905|NCT00265317|Secondary|Number of Participants on Anti-hypertensive Medications|Number of participants with BP greater than 150/100 mmHg or 200/110 mmHg who were treated with anti-hypertensive medications.|Randomization to Day 28 of Cycle 18|Per Protocol Set; data were not analyzed|||||
715906|NCT00265317|Secondary|Number of Participants With BP Greater Than 200/110 mmHg|Systolic/diastolic BP measured in triplicate (separated by approximately 2 minutes [min]) using validated electronic device (same device for all measurements), recorded to nearest mmHg. Dominant arm used (same one each time) with appropriate cuff size encircling at least 80% of arm. BP measured after 5 min rest and before invasive procedures, while seated in a chair with back supported, arms bared, supported at heart level. No smoking or caffeine use allowed during 30 min before measurement. Number of participants with systolic BP >150 mmHg/diastolic BP >100 mmHg at any timepoint postbaseline.|Randomization up until Month 17|Per-Protocol Set||Participants|||Number
715979|NCT00265330|Primary|Mean Change From Baseline in Supine Pulse Rates|Mean Change: vital sign value at observation minus vital sign value at baseline|Week 1 through Week 26|||beats per minute||Standard Deviation|Mean
715907|NCT00265317|Secondary|Number of Participants With Blood Pressure (BP) Greater Than 150/100 Millimeters of Mercury (mmHg)|Systolic/diastolic BP measured in triplicate (separated by approximately 2 minutes [min]) using validated electronic device (same device for all measurements), recorded to nearest mmHg. Dominant arm used (same one each time) with appropriate cuff size encircling at least 80% of arm. BP measured after 5 min rest and before invasive procedures, while seated in a chair with back supported, arms bared, supported at heart level. No smoking or caffeine use allowed during 30 min before measurement. Number of participants with systolic BP >150 mmHg/diastolic BP >100 mmHg at any timepoint postbaseline.|Randomization up until Month 17|Per-Protocol Set: all participants in the Phase 2 portion (randomized) who received at least 1 dose of study medication (either erlotinib or blinded medication) with treatment assignments designated according to actual study medication received||Participants|||Number
715908|NCT00265317|Secondary|EORTC-QLQ-C30 Lung Cancer Module (LC13) Score|The EORTC-QLQ-C30 LC13 is a self-administered questionnaire assessing specific lung cancer disease related symptoms (dyspnea, coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in the chest, arm/shoulder or other parts of the body). Recall period: past week; response range: not at all (1) to very much (4). Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.|Baseline (Cycle 1 [Day 1]) to Cycle 18 (Day 1)|PRO Analysis Set; n is number of participants with an assessment at the specific time point||score on a scale||95% Confidence Interval|Mean
715909|NCT00265317|Other Pre-specified|sKIT Ratio to Baseline at Each Timepoint|Plasma sKIT concentration at each time point divided by sKIT concentration at baseline (ratio to baseline)|Baseline to Cycle 2 (Day 1) and Cycle 3 (Day 1)|FA Set; n equals number of participants with evaluable data at specified cycle||Ratio||Full Range|Median
715910|NCT00265317|Secondary|Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score|EORTC QLQ-C30: self-administered questionnaire assessing global health status/quality of life (QoL), functional domains (physical, role, cognitive, emotional, and social), symptom scales/items (fatigue, pain, nausea and vomiting, dyspnea, insomnia, loss of appetite, constipation, and diarrhea), and financial difficulties. Recall period: past week; response range: not at all (1) to very much (4); global/QoL range: very poor (1) to excellent (7). Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Baseline (Cycle [C] 1, Day [D] 1) to Cycle 18, Day 1|Patient-Reported Outcome (PRO) Analysis Set: participants from the FA Set who had at least 1 EORTC QLQ-C30 or EORTC QLQ Lung cancer (QLQ-LC13) module questionnaire assessment while on treatment; n is number of participants with an assessment at the specified time point.||score on a scale||95% Confidence Interval|Mean
715911|NCT00265317|Other Pre-specified|VEGFR-3 Ratio to Baseline at Each Timepoint|Plasma VEGFR-3 concentration at each time point divided by VEGFR-3 concentration at baseline (ratio to baseline)|Baseline to Cycle 2 (Day 1) and Cycle 3 (Day 1)|FA Set; n equals number of participants with evaluable data at specified cycle||Ratio||Full Range|Median
715912|NCT00265317|Secondary|PFS in Subgroups That Were Defined by RNA Expression Profile|PFS, defined as time from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in subgroups that were defined by RNA Gene expression (CSF-1R, PDGFRalpha, PDGFRbeta, VEGF, VEGF-C, VEGFR1, VEGFR2, VEGFR3, FGF, FLT-3, KIT, and RET). PFS was calculated as (first event date minus randomization date plus 1) divided by 7.02.|From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)|FA Set||Weeks||95% Confidence Interval|Median
715913|NCT00265317|Other Pre-specified|VEGFR-2 Ratio to Baseline at Each Timepoint|Plasma VEGFR-2 concentration at each time point divided by VEGFR-2 concentration at baseline (ratio to baseline)|Baseline to Cycle 2 (Day 1) and Cycle 3 (Day 1)|FA Set; n equals number of participants with evaluable data at specified cycle||Ratio||Full Range|Median
715914|NCT00265317|Secondary|Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile|Includes colony-stimulating factor 1 receptor (CSF-1R), PDGFRalpha, PDGFRbeta, vascular endothelial growth factor (VEGF), VEGF C (VEGF-C), VEGF receptor 1 (VEGFR1), VEGF receptor 2 (VEGFR2), VEGF receptor 3 (VEGFR3), fibroblast growth factor (FGF), FLT-3, KIT (stem cell factor receptor), and RET (rearranged during transfection). Correlative analysis was conducted using tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable.|Baseline|FA Set||Percentage of Participants|||Number
715915|NCT00265317|Other Pre-specified|VEGF-C Ratio to Baseline at Each Timepoint|Plasma VEGF-C concentration at each time point divided by VEGF-C concentration at baseline (ratio to baseline)|Baseline to Cycle 2 (Day 1) and Cycle 3 (Day 1)|FA Set; n equals number of participants with evaluable data at specified cycle||Ratio||Full Range|Median
715916|NCT00265317|Secondary|Correlation of Polymorphisms in Stem Cell Factor Receptor (c-Kit), FMS-like Tyrosine Kinase 3 Receptor (FLT-3), and c-FMS With Blood Counts|A blood sample (6 mL) was collected before on-study treatment and was used to isolate DNA. These samples were not anonymized. Correlation was investigated by the percentage of participants with anemia (based on hemoglobin count), neutropenia (based on neutrophil count) and thrombocytopenia (based on platelet count) endpoints and genetic variation as measured by c-KIT, FLT-3, and c-FMS was to be analyzed.|Baseline (Day 1, Cycle 1)|Blood samples were collected; however, because of the small sample size that resulted in a lack of power for statistical testing, no formal statistical analyses were performed.|||||
715917|NCT00265317|Secondary|Percentage of Participants by Tumor VEGFR Mutation|Percentage of participants with VEGFR mutations in DNA from tumor samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable.|Baseline|Full Analysis - All Population; data were not analyzed|||||
715918|NCT00265317|Secondary|OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms|OS, defined as time from date of randomization to date of death due to any cause, in subgroups that were defined by PDGFRB polymorphisms. OS was calculated as (date of death minus date of randomization plus 1) divided by 30.4.|From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)|Per Protocol Caucasian Population||Months||95% Confidence Interval|Median
715980|NCT00265330|Primary|Mean Change From Baseline in Supine Diastolic Blood Pressure|Mean Change: vital sign value at observation minus vital sign value at baseline|Week 1 through Week 26|||millimeters mercury (mm Hg)||Standard Deviation|Mean
715920|NCT00265317|Secondary|Percentage of Participants With Germline Platelet-derived Growth Factor Receptor Beta (PDGFRB) Polymorphisms|Blood samples were collected at baseline for multiplex RT analysis of genes expressing proteins that are targets of sunitinib or involved in angiogenesis or tumor growth to determine expression levels. Percentage of participants with germline PDGFRB SNPs was reported for the following genotype frequencies: homozygous C alleles (C/C), T alleles (T/T), G alleles (G/G), or A alleles (A/A), and the following heterozygous genotypes C/T, A/T, A/G, T/C, T/G, G/C, C/A and G/A.|Baseline|Full Analysis - All Population||Percentage of Participants||95% Confidence Interval|Number
715921|NCT00265317|Secondary|Overall Survival (OS) in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms|OS, defined as time from date of randomization to date of death due to any cause, in subgroups that were defined by VEGFR2 polymorphisms. OS was calculated as (date of death minus date of randomization plus 1) divided by 30.4.|From randomization until death (up to Month 17)|Per Protocol Caucasian Population||Months||95% Confidence Interval|Median
715922|NCT00265317|Secondary|PFS in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms|PFS, defined as time from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in subgroups that were defined by VEGFR2 polymorphisms. PFS was calculated as (first event date minus randomization date plus 1) divided by 7.02.|From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)|Per Protocol Caucasian Population: all Caucasian participants in randomized phase who received at least 1 dose of study medication (either erlotinib or blinded medication), with treatment assignments designated according to actual study medication received||Weeks||95% Confidence Interval|Median
715923|NCT00265317|Secondary|Percentage of Participants With Germline Vascular Endothelial Growth Factor Receptor 2 (VEGFR2) Polymorphisms|Blood samples were collected at baseline for multiplex reverse transcription (RT) analysis of genes expressing proteins that are targets of sunitinib or involved in angiogenesis or tumor growth to determine expression levels. Percentage of participants with germline VEGFR2 single nucleotide polymorphisms (SNPs) was reported for the following genotype frequencies: homozygous C alleles (C/C), T alleles (T/T), G alleles (G/G), or A alleles (A/A), and the following heterozygous genotypes C/T, G/T, T/A, and G/A.|Baseline|Full Analysis - All Population: all participants from lead-in period and Phase 2 (randomized phase)||Percentage of Participants||95% Confidence Interval|Number
715924|NCT00265317|Secondary|PFS in Subgroups That Were Defined by KRAS Gene Mutation|PFS, defined as time from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in subgroups that were defined by KRAS gene mutation (reported as mutated, wild type, or indeterminate). PFS was calculated as (first event date minus randomization date plus 1) divided by 7.02.|From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)|FA Set||Weeks||95% Confidence Interval|Median
715925|NCT00265317|Secondary|Percentage of Participants With KRAS (V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog) Gene Mutations|Mutations in exons 2-3 of the KRAS gene (including codons 12, 13, and 61) were analyzed by high-performance liquid chromatography using DNA from tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable. The percentage of participants with KRAS mutations categorized as mutated, wild type or indeterminate was reported.|Baseline|FA Set||Percentage of Participants|||Number
715926|NCT00265317|Secondary|PFS in Subgroups That Were Defined by EGFR Gene Mutation|PFS, defined as time from date of randomization to date of first documentation of PD or to death on-study due to any cause, whichever occurred first, in subgroups that were defined by EGFR gene mutation (reported as mutated, wild type, or indeterminate). PFS was calculated as (first event date minus randomization date plus 1) divided by 7.02.|From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)|FA Set||Weeks||95% Confidence Interval|Median
715927|NCT00265317|Secondary|Percentage of Participants With EGFR Gene Mutation|Mutations in exons 18 through 21 of the EGFR gene were analyzed by high-performance liquid chromatography using DNA from tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable. The percentage of participants with EGFR mutations categorized as mutated, wild type or indeterminate was reported.|Baseline|FA Set||Percentage of Participants|||Number
715928|NCT00265317|Secondary|PFS in Subgroups That Were Defined by EGFR Gene Amplification|PFS, defined as time from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in subgroups that were defined by EGFR gene amplification (defined as greater than 15) and reported as no or unmeasured. PFS was calculated as (first event date minus randomization date plus 1) divided by 7.02.|From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)|FA Set||Weeks||95% Confidence Interval|Median
715929|NCT00265317|Secondary|Percentage of Participants With EGFR Gene Amplification|The percentage of participants with EGFR gene amplification (defined as greater than 15) was determined and reported as yes, no, or unmeasured. Correlative analysis of EGFR gene amplification was conducted using tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable.|Baseline|FA Set||Percentage of Participants|||Number
715930|NCT00265317|Secondary|PFS in Subgroups That Were Defined by EGFR Gene Copy Number Increase|PFS, defined as time from date of randomization to the date of the first documentation of PD or death on-study due to any cause, whichever occurred first, in subgroups that were defined by EGFR gene copy number increase (reported as yes, no, or unmeasured). The number of copies corresponding to exon 19 of the EGFR gene was determined and an increase was defined as greater than 4 copies. PFS was calculated as (first event date minus randomization date plus 1)/7.02.|From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)|FA Set||Weeks||95% Confidence Interval|Median
715931|NCT00265317|Secondary|Percentage of Participants With EGFR Gene Copy Number Increase|The number of copies corresponding to exon 19 of the EGFR gene was determined by real-time quantitative polymerase chain reaction (PCR). The percentage of participants with EGFR Gene Copy Number Increase (defined as greater than 4 copies) was determined using deoxyribonucleic acid (DNA) from tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable. Reported as yes, no or unmeasured.|Baseline|FA Set||Percentage of Participants|||Number
715932|NCT00265317|Secondary|PFS in Subgroups That Were Defined by EGFR Expression (Using 10% Cutoff)|PFS defined as time in weeks from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in the following subgroups: positive, negative, or unmeasured EGFR expression. EGFR expression was analyzed using a 10% cutoff where positive was greater than 10% of cells demonstrating membranous staining for EGFR. PFS calculated as (first event date minus randomization date plus 1) divided by 7.02.|From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)|FA Set||Weeks||95% Confidence Interval|Median
715933|NCT00265317|Secondary|Percentage of Participants With EGFR Expression by IHC (Using 10% Cutoff)|Percentage of participants with EGFR Expression by IHC using a 10% cutoff; Reported as positive (positive values were defined as being greater than 10% of cells demonstrating membranous staining for EGFR), negative, or unmeasured. Correlative analysis of EGFR expression was conducted using tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable.|Baseline|FA Set||Percentage of Participants|||Number
715934|NCT00265317|Secondary|PFS in Subgroups That Were Defined by EGFR Expression (Using 0% Cutoff)|PFS defined as time in weeks from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in the following subgroups: positive, negative, or unmeasured EGFR expression. EGFR expression was analyzed using a 0% cutoff where positive was greater than 0% of cells demonstrating membranous staining for EGFR. PFS calculated as (first event date minus randomization date plus 1) divided by 7.02.|From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)|FA Set||Weeks||95% Confidence Interval|Median
715935|NCT00265317|Secondary|Percentage of Participants With Epidermal Growth Factor Receptor (EGFR) Expression by Immunohistochemistry (IHC) Using 0 Percent [%] Cutoff|Percentage of participants with EGFR expression by IHC using a 0% cutoff; Reported as positive, negative, or unmeasured (where positive was greater than 0% of cells demonstrating membranous staining for EGFR). Correlative analysis of EGFR expression was conducted using tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable.|Baseline|FA Set||Percentage of Participants|||Number
715936|NCT00265317|Secondary|Dose-Corrected Ctrough for SU-012662 (Metabolite of Sunitinib) on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)|Ctrough = plasma concentration of SU-012662 prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. Assessed in the Original Cohort predose on Day 15 (Cycle 1, Time Zero) and Day 1 (Cycle 3), in the Amended Lead-In Cohort (Arms A and B) predose on Day 1 (Cycle 3) and in the Randomized Cohort (Sunitinib + Erlotinib treatment group only) predose on Day 1 of Cycles 1-18.|predose Day 15 (Cycle 1) and Day 1 (Cycle 3); predose Day 1 (Cycle 3); predose Day 1 (Cycles 1-18)|Number of participants analyzed (N)=participants with observations above LLOQ in Original Lead-In Cohort, Amended Lead-In Cohort (Arms A and B), Randomized Cohort (Sunitinib + Erlotinib treatment group only); n=number of participants with observations above LLOQ for specified cycle||ng/mL||Standard Deviation|Mean
715937|NCT00265317|Secondary|Dose-Corrected Ctrough for SU-012662 (Metabolite of Sunitinib) on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)|Ctrough = plasma concentration of SU-012662 prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. Assessed in the Original and Amended Lead-In (Arms A and B) Cohorts predose on Day 1 (Cycles 3-13) and in the Randomized Cohort (Sunitinib + Erlotinib treatment group only) predose on Day 1 of Cycles 1-18.|predose Day 1 (Cycles 3-13); predose Day 1 (Cycles 1-18)|Number of participants analyzed (N)=participants with observations above LLOQ in Original Lead-In Cohort, Amended Lead-In Cohort (Arms A and B), Randomized Cohort (Sunitinib + Erlotinib treatment group only); n=number of participants with observations above LLOQ for specified cycle||ng/mL||Standard Deviation|Mean
715938|NCT00265317|Secondary|Dose-Corrected Ctrough for Sunitinib on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)|Ctrough = plasma concentration of sunitinib prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. Assessed in the Original Cohort predose on Day 15 (Cycle 1, Time Zero) and Day 1 (Cycle 3), in the Amended Lead-In Cohort (Arms A and B) predose on Day 1 (Cycle 3) and in the Randomized Cohort (Sunitinib + Erlotinib treatment group only) predose on Day 1 of Cycles 1-18.|predose Day 15 (Cycle 1) and Day 1 (Cycle 3); predose Day 1 (Cycle 3); predose Day 1 (Cycles 1-18)|Number of participants analyzed (N)=participants with observations above LLOQ in Original Lead-In Cohort, Amended Lead-In Cohort (Arms A and B), Randomized Cohort (Sunitinib + Erlotinib treatment group only); n=number of participants with observations above LLOQ for specified cycle||ng/mL||Standard Deviation|Mean
715939|NCT00265317|Secondary|Dose-Corrected Ctrough for Sunitinib on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)|Ctrough = plasma concentration of sunitinib prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. Assessed in the Original and Amended Lead-In (Arms A and B) Cohorts predose on Day 1 (Cycles 3-13) and in the Randomized Cohort (Sunitinib + Erlotinib treatment group only) predose on Day 1 of Cycles 1-18.|predose Day 1 (Cycles 3-13); predose Day 1 (Cycles 1-18)|Number of participants analyzed (N)=participants with observations above LLOQ in Original Lead-In Cohort, Amended Lead-In Cohort (Arms A and B), Randomized Cohort (Sunitinib + Erlotinib treatment group only); n=number of participants with observations above LLOQ for specified cycle||ng/mL||Standard Deviation|Mean
715940|NCT00265317|Secondary|Dose-Corrected Ctrough for Erlotinib on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)|Ctrough = plasma concentration of erlotinib prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. Assessed in the Original Cohort predose on Day 15 (Cycle 1, Time Zero) and Day 1 (Cycle 3), in the Amended Lead-In Cohort (Arms A and B) predose on Day 1 (Cycle 3) and in the Randomized Cohort (Sunitinib + Erlotinib treatment group only) predose on Day 1 of Cycles 1-18.|predose Day 15 (Cycle1); predose Day 1 (Cycle 3); predose Day 1 (Cycles 1-18)|Number of participants analyzed (N)=participants with observations above LLOQ in Original Lead-In Cohort, Amended Lead-In Cohort (Arms A and B), Randomized Cohort (Sunitinib + Erlotinib treatment group only); n=number of participants with observations above LLOQ for specified cycle||mcg/mL||Standard Deviation|Mean
715941|NCT00265317|Secondary|Dose-Corrected Observed Plasma Trough Concentrations (Ctrough) for Erlotinib on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)|Ctrough = plasma concentration of erlotinib prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. Assessed in the Original and Amended Lead-In (Arms A and B) Cohorts predose on Day 1 (Cycles 3-13) and in the Randomized Cohort (Sunitinib + Erlotinib treatment group only) predose on Day 1 of Cycles 1-18.|predose Day 1 (Cycles 3-13); predose Day 1 (Cycles 1-18)|Number of participants analyzed (N)=participants with observations above lower limit of quantification (LLOQ) in Original Lead-In Cohort, Amended Lead-In Cohort (Arms A and B), Randomized Cohort (Sunitinib + Erlotinib treatment group only); n=number of participants with observations above LLOQ for specified cycle||mcg/mL||Standard Deviation|Mean
715942|NCT00265317|Secondary|Tmax for Total Drug (Sunitinib + SU-012662)||Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose|Amended Lead-In Cohort Arm B||Hours||Full Range|Median
715943|NCT00265317|Secondary|Tmax for SU-012662 (Metabolite of Sunitinib)||Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose|Amended Lead-In Cohort Arm B||Hours||Full Range|Median
715944|NCT00265317|Secondary|Tmax for Sunitinib||Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose|Amended Lead-In Cohort Arm B||Hours||Full Range|Median
715945|NCT00265317|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) for Erlotinib||Days 1 and 22 (Cycle 1) at 0, 1, 2, 4, 6, 8, and 24 hours postdose|Amended Lead-In Cohort Arm A||Hours||Full Range|Median
715946|NCT00265317|Secondary|Sunitinib Clearance at Steady State After Oral Administration (CL/F)||Day 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose|Number of participants with calculable data in Original Lead-In Cohort; after protocol amendment 3, the study design was modified (steady-state versus single dose), due to the long half-life of the drug, sample collection just up to 48 hours was not sufficient for the calculation of CL/F for Amended Lead-In Arm B.||L/hr||Standard Deviation|Mean
715947|NCT00265317|Secondary|Erlotinib Clearance at Steady State After Oral Administration (CL/F)||Day 15 (Cycle 1) at 0, 1, 2, 4, 6, 8, and 24 hours postdose|Number of participants with calculable data in Original Lead-In; after protocol amendment 3, the study design was modified (steady-state versus single dose), due to the long half-life of the drug, sample collection just up to 24 hours was not sufficient for the calculation of CL/F for Amended Lead-In Arm A.||Liters (L)/hr||Standard Deviation|Mean
715948|NCT00265317|Secondary|Plasma Decay Half-life (t1/2) of Sunitinib|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose|Amended Lead-In Cohort Arm B; Due to the long half-life of the drug and sample collection just up to 48 hours only, t1/2 could not be accurately estimated.|||||
715949|NCT00265317|Secondary|Plasma Decay Half-life (t1/2) of Erlotinib|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Days 1 and 22 (Cycle 1) at 0, 1, 2, 4, 6, 8, and 24 hours postdose|Amended Lead-In Cohort Arm A; Due to the long half-life of the drug and sample collection just up to 24 hours only, t1/2 could not be accurately estimated.|||||
715950|NCT00265317|Secondary|AUC(0-inf) for Total Drug (Sunitinib + SU-012662)|AUC(0-inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf) for total drug (sunitinib + SU-012662). It is obtained from AUC(0-t) plus AUC(t-inf)|Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose; predose on Days 15, 16, and 17 (Cycle 1)|Amended Lead-In Cohort Arm B; Due to the long half-life of the drug and sample collection just up to 48 hours only, AUC(0-inf) could not be accurately estimated.|||||
715951|NCT00265317|Secondary|AUC(0-inf) for SU-012662 (Metabolite of Sunitinib)|AUC(0-inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf) for SU-012662 (metabolite of sunitinib). It is obtained from AUC(0-t) plus AUC(t-inf)|Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose; predose on Days 15, 16, and 17 (Cycle 1)|Amended Lead-In Cohort Arm B; Due to the long half-life of the drug and sample collection just up to 48 hours only, AUC(0-inf) could not be accurately estimated.|||||
715952|NCT00265317|Secondary|AUC(0-inf) for Sunitinib|AUC (0 - inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf) for sunitinib. It is obtained from AUC(0-t) plus AUC(t-inf)|Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose; predose on Days 15, 16, and 17 (Cycle 1)|Amended Lead-In Cohort Arm B; Due to the long half-life of the drug and sample collection just up to 48 hours only, AUC(0-inf) could not be accurately estimated.|||||
715953|NCT00265317|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC0-inf) for Erlotinib|AUC (0-inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf) for erlotinib. It is obtained from AUC from time zero (pre-dose) to last quantifiable concentration(AUC[0-t]) plus AUC from time last quantifiable concentration extrapolated infinite time (AUC[t-inf])|Days 1 and 22 (Cycle 1) at 0, 1, 2, 4, 6, 8, and 24 hours postdose; predose on Days 22 and 23 (Cycle 1)|Amended Lead-In Cohort Arm A; Due to the long half-life of the drug and sample collection just up to 24 hours only, AUC(0-inf) could not be accurately estimated.|||||
715954|NCT00265317|Secondary|Cmax of Total Drug (Sunitinib + SU-012662)||Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose|Amended Lead-In Cohort Arm B||ng/mL||Standard Deviation|Mean
715955|NCT00265317|Secondary|Cmax of SU-012662 (Metabolite of Sunitinib)||Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose|Amended Lead-In Cohort Arm B||ng/mL||Standard Deviation|Mean
715956|NCT00265317|Secondary|Cmax of Sunitinib||Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose|Amended Lead-In Cohort Arm B||ng/mL||Standard Deviation|Mean
715957|NCT00265317|Secondary|Maximum Observed Plasma Concentration (Cmax) of Erlotinib||Days 1 and 22 (Cycle 1) at 0, 1, 2, 4, 6, 8, and 24 hours postdose|Amended Lead-In Cohort Arm A||mcg/mL||Standard Deviation|Mean
715958|NCT00265317|Secondary|AUC(0-24) of Total Drug (Sunitinib + SU-012662)|AUC0-24=Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours (0-24) of total drug (sunitinib + SU-012662)|Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, and 24 hours postdose|Amended Lead-In Cohort Arm B||ng*hr/mL||Standard Deviation|Mean
715959|NCT00265317|Secondary|AUC(0-24) of SU-012662 (Metabolite of Sunitinib)|AUC0-24=Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours (0-24) of SU-012662 (metabolite of sunitinib)|Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, and 24 hours postdose|Amended Lead-In Cohort Arm B||ng*hr/mL||Standard Deviation|Mean
715960|NCT00265317|Secondary|AUC(0-24) of Sunitinib|AUC0-24=Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours (0-24) of sunitinib|Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, and 24 hours postdose|Amended Lead-In Cohort Arm B: participants received sunitinib for 28 days each cycle (13 days in Cycle 1) and erlotinib QD for 28 days each cycle (26 days in Cycle 1).||nanograms (ng)*hr/mL||Standard Deviation|Mean
715961|NCT00265317|Secondary|Area Under the Curve From Time Zero to 24 Hours [AUC(0-24)] of Erlotinib|AUC0-24=Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours (0-24) of erlotinib|Days 1 and 22 (Cycle 1) at 0, 1, 2, 4, 6, 8, and 24 hours postdose|Amended Lead-in Cohort Arm A: participants received sunitinib QD for 28 days each cycle (27 days in Cycle 1) and erlotinib QD for 28 days each cycle (7 days in Cycle 1)||micrograms (mcg)*hour(hr)/milliliter (mL||Standard Deviation|Mean
715962|NCT00265317|Secondary|Percentage of Participants Surviving at 1 Year|Percentage of participants alive at 1 year after date of first administration of study medication.|From randomization until death (up until Month 17)|FA Set||Percentage of Participants|||Number
715963|NCT00265317|Secondary|Overall Survival (OS)|OS was defined as time from date of randomization to date of death due to any cause. OS was calculated as (date of death minus date of randomization plus 1) divided by 30.4. For participants still alive at the time of analysis, OS time was censored on last date that participants were known to be alive.|From randomization until death (up to Month 17)|FA Set||Months||95% Confidence Interval|Median
715964|NCT00265317|Secondary|Duration of Response (DR)|DR was defined as time from first documentation of objective tumor response (CR or PR) that was subsequently confirmed to the first documentation of PD or death on-study due to any cause, whichever occurred first. DR was calculated as (first date of PD or death minus first date of CR or PR that was subsequently confirmed plus 1) divided by 7.02.|From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)|FA subset of participants with a confirmed objective response were to be analyzed. As only 3 and 2 responses were observed, duration of response was not analyzed.|||||
715965|NCT00265317|Secondary|Time to Tumor Progression (TTP)|TTP was defined as the time from date of randomization to first documentation of PD based on third party independent imaging review laboratory assessment. TTP was calculated as (first event date minus randomization date plus 1) divided by 7.02.|From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)|FA Set||Weeks||95% Confidence Interval|Median
715966|NCT00265317|Secondary|Percentage of Participants With Objective Response|Objective Response Rate (ORR)=participants with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST,Version 1.0) based on third party independent imaging review laboratory assessment. A CR was defined as the disappearance of all target lesions that persisted on repeat imaging study at least 4 weeks after initial documentation of response. A PR was defined as a ≥30% decrease in sum of longest dimensions of target lesions taking as a reference the baseline sum longest dimensions.|From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)|FA Set||Percentage of Participants||95% Confidence Interval|Number
715967|NCT00265317|Primary|Progression-Free Survival (PFS)|PFS=time from randomization date to date of first documentation of progressive disease (PD; defined as greater than or equal to [≥]20% increase in sum of longest dimensions of target lesions taking as a reference smallest sum of longest dimensions recorded since first dose or appearance of ≥1 new lesions) or death on-study due to any cause, whichever occurred first based on third party independent imaging review laboratory assessment. PFS calculated as (first event date minus randomization date plus 1) divided by 7.02. Used 7.02 days as it equals 365 days per year divided by 52 weeks per year.|From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)|Full Analysis Set (FA):all participants in randomized phase randomized with study medication assignment designated according to initial randomization, regardless of whether participants actually received study medication or received different medication from what they were randomized.||Weeks||95% Confidence Interval|Median
715968|NCT00265330|Primary|Frequency of Largest Categorical Increases in QTcF - All Subjects|QT intervals (observed in an electrocardiogram)corrected using Fridericia Formula (QTcF). Number of subjects with corresponding categorical increase in QTcF.|Week 26 (end of study)|||participants|||Number
715969|NCT00265330|Primary|Frequency of Largest Categorical Increases in QTcF for Females|QT interval (observed in an electrocardiogram) corrected using Fridericia Formula (QTcF). Number of subjects with corresponding categorical increase in QTcF.|Week 26 (end of study)|||participants|||Number
715970|NCT00265330|Primary|Frequency of Largest Categorical Increases in QTcF for Males|QT intervals (observed in an electrocardiogram) corrected with Fridericia's Formula (QTcF). Number of subjects with corresponding categorical increase in QTcF.|Week 26 (end of study)|||participants|||Number
715971|NCT00265330|Primary|Mean Change From Baseline for QTcF Intervals|QT intervals (observed in an electrocardiogram)corrected using Fridericia’s formula (QTcF). Mean change: mean change of observation minus baseline. Baseline: last available observation in the parent double-blind study.|Baseline to Week 26 (end of study)|||millisecond||Standard Deviation|Mean
715972|NCT00265330|Primary|Body Mass Index (BMI) Z-score Frequency|change in body weight BMI -Z score calculated by subtracting median reference value of the population from observed value and dividing by standard deviation of reference population (kg/m squared). 0=no change|Week 26|||participants|||Number
715973|NCT00265330|Primary|Body Mass Index (BMI) Z-score Frequency|change in body weight BMI -Z score calculated by subtracting median reference value of the population from observed value and dividing by standard deviation of reference population (kg/m squared). 0=no change|Week 6|||participants|||Number
715974|NCT00265330|Primary|Mean Change From Baseline for Body Mass Index (BMI) Z-Score|mean change in body weight BMI -Z score calculated by subtracting median reference value of the population from observed value and dividing by standard deviation of reference population (kg/m squared). 0=no change|Week 6, 26, early termination|||score on scale||Standard Deviation|Mean
715975|NCT00265330|Primary|Mean Change From Baseline for Body Weight|Mean change; body weight value at observation minus body weight value at baseline.|Week 6, Week 26|||kilogram||Standard Deviation|Mean
715976|NCT00265330|Primary|Mean Change From Baseline in Standing Pulse Rates|Mean Change: vital sign value at observation minus vital sign value at baseline|Week 1 through Week 26|||beats per minute||Standard Deviation|Mean
715982|NCT00265330|Primary|Change in Hormones|Mean Change: lab value at observation minus lab value at baseline|Week 6, Week 26|The Safety Analysis Set includes all subjects who took at least one dose of study medication in this open-label extension study. (Row: n= total number of subjects with at least 1 observation of the given laboratory test.)||nanogram/deciliter (ng/dL)||Standard Deviation|Mean
715983|NCT00265330|Primary|Change in Low-Density Lipoprotein (LDL) Cholesterol and Fasting Cholesterol|Mean Change: lab value at observation minus lab value at baseline.|Week 6, Week 26|The Safety Analysis Set includes all subjects who took at least one dose of study medication in this open-label extension study. (Row: n= total number of subjects with at least 1 observation of the given laboratory test.)||milligram /deciliter (mg/dL)||Standard Deviation|Mean
715984|NCT00265330|Primary|Incidence of Lab Abnormalities|number of subjects with an abnormal lab value for those parameters with 5% or greater incidence of abnormality.|Week 26|Total number of subjects with given laboratory test at given visit. Range: N=136-134, with the exception of Insulin (N=115)||participants|||Number
715985|NCT00265330|Primary|Clinical Global Impression of Severity (CGI-S) Change From Baseline|CGI-S Scale:standardized assessment tool to rate severity of subject’s illness; assesses investigator’s impression of subject’s current illness state. Change: score at observation minus score at baseline. Score: 1 (not ill at all) to 7 (among most extremely ill). Baseline = last available observation from parent double-blind study(A1281132).|baseline and 26 Weeks; 26 Weeks LOCF|The Safety Analysis Set includes all subjects who took at least one dose of study medication in this open-label extension study. (Row: n=number subjects with observation)||score on scale||Standard Deviation|Mean
715986|NCT00265330|Primary|Young Mania Rating Scale (YMRS) Total Score Change From Baseline|YMRS: 11-item instrument with scales 0 (normal) to 4 (highest abnormal)for 7 items and 0 (normal) to 8 (highest abnormal) for 4 items. Total possible 0 - 60. Baseline is from parent study A1281132.|baseline and 26 Weeks; 26 Weeks Last Observation Carried Forward (LOCF)|The Safety Analysis Set includes all subjects who took at least one dose of study medication in this open-label extension study. (Row: n=number subjects with observation)||score on scale||Standard Deviation|Mean
715987|NCT00265343|Secondary|Change in Quality of Life Measured by Quality of Life Scale (QLS)|Increase from baseline in the QLS scores indicates improvement of efficacy. Range QLS total score is 0 [worst]-126 [best].|Baseline of Protocol 25543 (NCT 00212836) to 365 days (total time for both protocols 25543 & 25544)|Intent-to-treat population||Units on a Scale||Standard Error|Least Squares Mean
715988|NCT00265343|Primary|Long-term Change in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale|Decrease from baseline in the NSA scores indicates improvement of efficacy. Range NSA total score is 16 [best]-96 [worst].|Baseline of Protocol 25543 (NCT 00212836) to 365 days (total time for both protocols 25543 & 25544)|Intent-to-treat population||Units on a Scale||Standard Error|Least Squares Mean
715989|NCT00265382|Secondary|Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance|School placement questionnaire: parent or legal guardian assessed questionnaire to determine whether the child is currently enrolled in school (or planned to be enrolled if on school holiday like summer break), whether attending regularly if enrolled, and how well the child is doing overall in school. Questions were modified from those used in the National Institute of Mental Health (NIMH) funded Treatment of Early Onset Schizophrenia Spectrum (TEOSS) study. Results determine whether subjects are currently attending school and qualitatively describe how well they are doing in school.|Baseline, Weeks 6 and 26, ET|Safety Analysis Set. N=number of subjects analyzable for School Placement Questionnaire; n=number of subjects with analyzable data at baseline and post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.||participants|||Number
715990|NCT00265382|Secondary|Number of Subjects Per Response on the School Placement Questionnaire: School Attendance|School placement questionnaire: parent or legal guardian assessed questionnaire to determine whether the child is currently enrolled in school (or planned to be enrolled if on school holiday like summer break), whether attending regularly if enrolled, and how well the child is doing overall in school. Questions were modified from those used in the National Institute of Mental Health (NIMH) funded Treatment of Early Onset Schizophrenia Spectrum (TEOSS) study. Results determine whether subjects are currently attending school and qualitatively describe how well they are doing in school.|Baseline, Weeks 6 and 26, ET|Safety Analysis Set. N=number of subjects analyzable for School Placement Questionnaire; n=number of subjects with analyzable data at baseline and post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.||participants|||Number
715991|NCT00265382|Secondary|Number of Subjects Per Response on the School Placement Questionnaire: School Situation|School placement questionnaire: parent or legal guardian assessed questionnaire to determine whether the child is currently enrolled in school (or planned to be enrolled if on school holiday like summer break), whether attending regularly if enrolled, and how well the child is doing overall in school. Questions were modified from those used in the National Institute of Mental Health (NIMH) funded Treatment of Early Onset Schizophrenia Spectrum (TEOSS) study. Results determine whether subjects are currently attending school and qualitatively describe how well they are doing in school.|Baseline, Weeks 6 and 26, ET|Safety Analysis Set. N=number of subjects analyzable for School Placement Questionnaire; n=number of subjects with analyzable data at baseline and post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.||participants|||Number
715992|NCT00265382|Secondary|Change From Baseline in Child Health Questionnaire (CHQ)|CHQ: 50-item, 15 subscale parent or legal guardian assessed instrument of child's physical, emotional, social well-being, and relative burden of disease on the parents; rated on Likert-type scale: range 0 to 100; higher scores indicate a more positive health status. Global indicators for Physical Health and Psychosocial Health are weighted composites derived from subscale items using scoring algorithms (transformed scores); range 0 to 100: higher scores indicate more positive health status.|Baseline, Weeks 6 and 26, ET|Safety Analysis Set. N=number of subjects with analyzable data at baseline; n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.||scores on a scale||Standard Deviation|Mean
716085|NCT00255970|Primary|Clinical Attachment Level|The amount of space between attached periodontal tissues and a fixed point, usually the cementoenamel junction. A measurement used to assess the stability of attachment as part of a periodontal maintenance program.|6 months|||mm||Standard Deviation|Mean
715993|NCT00265382|Secondary|Change From Baseline in Children's Global Assessment Scale (CGAS)|"CGAS: clinician-rated global assessment item for children based on symptoms and social functioning in home, school, and community settings. Scores on this single item range from 1 to 100 (higher levels indicate greater health) with descriptive anchors for every 10-point interval. Scores above 70 on this scale are considered within the normal range; lower score indicates need for increased supervision."|Baseline, Weeks 2, 6, 18, 26, ET|Safety Analysis Set. N=number of subjects with analyzable data at baseline; n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.||scores on a scale||Standard Deviation|Mean
715994|NCT00265382|Secondary|Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total Score|BPRS-A: 18-item clinician rated scale to assess somatic concern, anxiety, emotional withdrawal, disorganization, hallucinatory behavior, guilt feelings, suspiciousness, disorientation, tension, mannerisms, posturing, grandiosity, depressive mood, hostility, motor retardation, uncooperativeness, unusual thought content, blunted affect, excitement. Ratings anchored to improve consistency for single rater over time or between raters. Items rated on 7-point scale 0 (not present) to 6 (extremely severe). Total score=sum of items (range 0 to 108); higher scores indicate increased pathology.|Baseline, Weeks 2, 6, 18, 26, ET|Safety Analysis Set. N=number of subjects with analyzable data at baseline; n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.||scores on a scale||Standard Deviation|Mean
715995|NCT00265382|Secondary|Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Movement Cluster Score|AIMS: clinician rated 12-item scale to rate 7 body areas and global judgments on the severity of abnormal movements, incapacitation and subject's awareness of abnormal movements. Items 1 to 10 scored 0 (none) to 4 (severe) (total possible score 0 to 40; higher score indicates greater severity); items 11 to 14 are No or Yes response to dental status and sleep movements. Only the sum of the first 7 items to be analyzed (AIMS Movement Cluster score). Total score 0 to 28; higher score indicates greater severity.|Baseline, Weeks 1, 2, 6, 10, 14, 18, 22, 26, ET|Safety Analysis Set. N=number of subjects with analyzable data at baseline; n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.||scores on a scale||Standard Deviation|Mean
715996|NCT00265382|Secondary|Change From Baseline in Barnes Akathisia Rating Scale (BAS) Global Clinical Assessment Item|BAS: clinician rated scale to assess akathisia to determine the degree of subjective restlessness and distress associated with restlessness. First 3 items (Objective, Subjective, and Distress related to restlessness) rated on a 4-point scale with range 0 (no symptoms) to 3 (increased severity of symptoms). Item 4 Global Clinical Assessment of Akathisia rated on a 6- point scale range 0 (no symptoms) to 5 (increased severity of symptoms); higher score indicates increased severity. All rating are anchored. Only the Global Clinical Assessment of Akathisia was to be analyzed.|Baseline, Weeks 1, 2, 6, 10, 14, 18, 22, 26, ET|Safety Analysis Set. N=number of subjects with analyzable data at baseline; n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.||scores on a scale||Standard Deviation|Mean
715997|NCT00265382|Secondary|Change From Baseline in Simpson-Angus Rating Scale (SARS)|SARS: 10-item clinician rated instrument to assess parkinsonian symptoms (7 items) and related extrapyramidal side effects (3 items): gait, arm dropping, shoulder shaking, elbow rigidity, leg pendulousness, glabellar tap, tremor, and salivation. Head dropping (modified SARS item 7) substituted for head rotation. Anchored 5-point scale: range 0 (absence of condition, normal) to 4 (most extreme form of condition). Total score is sum of individual item scores (range 0 to 40); higher score indicates more affected.|Baseline, Weeks 1, 2, 6, 10, 14, 18, 22, 26, ET|Safety Analysis Set. N=number of subjects with analyzable data at baseline; n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.||scores on a scale||Standard Deviation|Mean
715998|NCT00265382|Secondary|Change From Baseline in CNS Vital Signs Cognitive Test Battery: Neurocognitive Index|Computerized subject-administered test battery with subtests for verbal and visual memory, processing speed, nonverbal reasoning, executive functioning, working memory, sustained attention. Computerized 7- point sedation item (0 [not sleepy] to 10 [very sleepy]) was completed prior to test battery. Neurocognitive index score was derived from subtest scores per an algorithm. Index score and subtest scores assessed the subject's changes in cognition. Scores were rated as above average (score >109), average (90 to 109), below average (80 to 89), or well below average (70 to 79).|Baseline, Weeks 6 and 26, ET|Safety Analysis Set. N=number of subjects with analyzable data at baseline; n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.||scores on a scale||Standard Deviation|Mean
715999|NCT00265382|Secondary|Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales|Computerized subject-administered test battery with subtests for verbal and visual memory, processing speed, nonverbal reasoning, executive functioning, working memory, sustained attention. Computerized 7- point sedation item (0 [not sleepy] to 10 [very sleepy]) was completed prior to test battery. Neurocognitive index score was derived from subtest scores per an algorithm. Index score and subtest scores assessed the subject's changes in cognition. Scores were rated as above average (score >109), average (90 to 109), below average (80 to 89), or well below average (70 to 79).|Baseline, Weeks 6 and 26, ET|Safety Analysis Set. N=number of subjects with analyzable data at baseline; n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.||scores on a scale||Standard Deviation|Mean
716020|NCT00265759|Secondary|Rate of Improved Surgical Outcome for Patients Designated as Candidates for Mastectomy Prior to Therapy (Cohort A)|Rate (percentage) of Improved surgical outcome for patients designated as candidates for mastectomy prior to therapy (Cohort A). Breast conservation surgery (not mastectomy) as the most extensive surgery performed for a patient is considered an improvement in surgical outcome.|At time of surgery up to 18 weeks|Overall Number of Participants Analyzed only includes patients considered candidates for mastectomy prior to therapy.||percentage of patients||95% Confidence Interval|Number
716000|NCT00265382|Secondary|Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Total Score|CDRS-R: clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment.|Baseline, Weeks 1, 2, 6, 10, 14, 18, 22, 26, ET|Safety Analysis Set. N=number of subjects with analyzable data at baseline; n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.||scores on a scale||Standard Deviation|Mean
716001|NCT00265382|Secondary|Change From Baseline in Children's Problem Behavior and Aggression Questionnaire (CPBAQ) Total Score|CPBAQ: 19-item parent or legal guardian completed questionnaire to rate the child's verbal (such as yelling or cursing) and physical aggression (such a fighting with peers or being cruel to an animal) during the past week. Behavior was rated on a 4-point scale; range 0 (behavior did not occur or was not a problem) to 3 (behavior occurred a lot or was severe problem). Total score range 0 to 57; higher scores indicate a greater frequency and severity of aggression.|Baseline, Weeks 2, 6, 18, 26, ET|Safety Analysis Set. N=number of subjects with analyzable data at baseline; n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). Last Observation Carried Forward (LOCF) imputation used for Week 26 LOCF time point.||scores on a scale||Standard Deviation|Mean
716002|NCT00265382|Secondary|Number of Subjects With Change From Baseline to Each Pubertal Stage of Development as Assessed by the Tanner Adolescent Pubertal Self Assessment|Tanner Adolescent Pubertal Staging Questionnaire: used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; males pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size).|Baseline, Week 26, Early Termination (ET)|Safety Analysis Set. N=number of subjects with analyzable data at baseline. Baseline data from Study A1281134 (NCT00257192) served as the baseline for A1281135.||participants|||Number
716003|NCT00265382|Primary|Number of Subjects With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|All observed or volunteered treatment-emergent AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product(s) were reported.|26 weeks|Safety Analysis Set = all subjects who took at least one dose of study medication. In this table, the number of subjects with AEs is based on a 0% AE threshold whereas the number of subjects with AEs reported in the AE section are based on a 5% AE threshold.||participants|||Number
716004|NCT00265395|Primary|Sustained Virologic Response, Defined as a Plasma HCV-RNA (Hepatitis C Ribonucleic Acid) Level Below the LLQ (Lower Level of Quantitation) at 24 Weeks Post-treatment.|LLQ = 30 IU/mL by reverse transcription polymerase chain reaction (RT-PCR) (Taqman Roche)|48 or 72 weeks of treatment plus 24 weeks of follow-up.|According to the protocol, the efficacy analysis was carried out on all slow responders (ie, patients who had at least 2 log drop in HCV-RNA level at treatment week 12, and undetectable HCV-RNA at treatment week 24).||Participants|||Number
716005|NCT00265473|Secondary|Insulin Independent Multiple-donor Subjects.|Proportion of insulin independent multiple-donor subjects at one year after final transplant. Participant received more than one islet transplant.|At one year after final transplant|||participants|||Number
716006|NCT00265473|Secondary|Insulin Independent Single-donor Subjects.|Proportion of insulin independent single-donor subjects at day 75 after transplant|At 75 days after transplant|||Participants|||Number
716007|NCT00265473|Secondary|Subjects With Partial Islet Function and no Episodes of Severe Hypoglycemia;|Proportion of subjects with partial islet function and no episodes of severe hypoglycemia at one year after initial islet transplant.|At one year after initial transplant|||Participants|||Number
716008|NCT00265473|Primary|Serious Adverse Events Related to Immunosuppressive Therapy.|Number of serious adverse events related to immunosuppressive therapy.|Day 0 - Day 365|||Serious Adverse Events|||Number
716009|NCT00265473|Primary|Subjects With Full Islet Function.|Proportion of subjects with full islet function (i.e. insulin independent) at one year after initial islet transplant.|At one year after initial transplant.|The number of participants was based on the participants that were actually transplanted.||Participants|||Number
716010|NCT00265512|Secondary|Quality of Life||Psychiatric symptoms and quality of life are measured at baseline, 3 months, 6 months and 12 months after enrollment into the study.||||||
716011|NCT00265512|Secondary|Psychiatric Symptoms||Psychiatric symptoms and quality of life are measured at baseline, 3 months, 6 months and 12 months after enrollment into the study.||||||
716012|NCT00265512|Primary|Rates of Substance Use|Percentage of days abstinent from alcohol use. Each person is followed for 3 months. For each person, we then calculate the number of days they were abstinent and the percentage of days abstinent (days abstinent/ all days in 3 months).|Rates of substance use measured at 3 months|||percentage of days||Standard Error|Mean
716013|NCT00265616|Secondary|Intubation Time in Survivors||Up to 3 months|||days||Full Range|Median
716014|NCT00265616|Primary|Refractory Status Epilepticus Controlled With First Course of Study Drug|Control of status epilepticus refractory to benzodiazepines and a first antiepileptic drug after administration of the study drug; dichotomous assessment (yes/no)|after return of continuous EEG activity (typically after 36 hours - 5 days)|Number of patients fulfilling primary outcome criteria||participants|||Number
716015|NCT00265616|Secondary|Patients With Propofol Infusion Syndrome|Propofol infusion syndrome (PRIS) is a severe metabolic alteration with elevation of lactate, CK, and triglycerides.|10 days|||participants|||Number
716016|NCT00265616|Secondary|Patients With Hypotension Requiring Specific Treatment||10 days|||participants|||Number
716017|NCT00265616|Secondary|Patients With Infectious Complications Requiring Specific Treatment||10 days|||participants|||Number
716018|NCT00265616|Secondary|Clinical Outcome at Day 21|Return to baseline clinical conditions (i.e.: no new handicap, no death)|21 days|||participants|||Number
716019|NCT00265759|Secondary|Overall Survival (Cohort A and B)|Overall survival (OS) will be measured from the date of randomization until the date of death. The distribution of overall survival times will be estimated using the Kaplan-Meier method.|assessed up to 10 years||08/2022||||
716021|NCT00265759|Secondary|Clinical Response Rate (Cohort B)|The clinical response rate is defined as 100 times the number of eligible patients whose disease meets the WHO criteria for complete or partial response prior to surgery divided by the total number of eligible patients. A 90% binomial confidence interval will be constructed for the true clinical response rate.|Up to 18 weeks|Outcome Measure Data Not Collected.|||||
716022|NCT00265759|Secondary|The Pathologic Complete Response (pCR) Rate (Cohort A)|The pathologic complete response is defined as no histologic evidence of invasive tumor cells in the surgical breast specimen and axillary or sentinel lymph nodes. The pathologic complete response rate (percentage) of a given treatment is defined as 100 times the number of eligible patients randomized to that treatment whose surgical specimen is such that there is no histologic evidence of invasive tumor cells in the surgical breast specimen and axillary or sentinel lymph nodes divided by the total number of eligible patients randomized to that treatment. For each neo-adjuvant endocrine treatment pair, a 95% binomial confidence interval will be constructed for the true difference in the pCR between these 2 treatments.|At time of surgery up to 18 weeks|Overall Number of Participants Analyzed only includes patients who had surgery performed after completion of AI therapy.||percentage of patients||95% Confidence Interval|Number
716023|NCT00265759|Secondary|Rate of Lymph Node Involvement (LNI) (Cohort A)|For those patients who undergo a sentinel lymph node dissection or an axillary lymph node dissection (at least 6 nodes examined with Hematoxylin & Eosin Staining), the LNI rate (percentage) is defined as 100 times the proportion of eligible patients randomized to that treatment with at least one positive node. For each neo-adjuvant endocrine treatment, a 95% binomial confidence interval will be constructed for its true LNI rate.|At time of surgery up to 18 weeks|Overall Number of Participants Analyzed include only patients who were evaluated for the number of positive nodes and not evaluated before or during AI therapy.||percentage of patients||95% Confidence Interval|Number
716024|NCT00265759|Secondary|Rate of Downstaging to Stage I Determined by Sentinel Node Evaluation (Cohort A)|The rate downstaging to Stage I of a given treatment is defined as 100 times the number of eligible patients randomized to that treatment whose surgically findings are such that the maximum dimension of the invasive lesion contained in their surgical specimen is at most 2 cm and their lymph nodes are negative (by Hematoxylin & Eosin Staining) divided by the total number of eligible patients randomized to that treatment. For each neo-adjuvant endocrine treatment pair, a 95% binomial confidence interval will be constructed for the true difference in the rate of downstaging to Stage I between these 2 treatments.|At time of surgery up to 18 weeks|Outcome Measure Data Not Collected.|||||
716025|NCT00265759|Secondary|Rate of Improved Surgical Outcome for Patients Considered Marginal for Breast Conservation Surgery Prior to Therapy (Cohort A)|The rate (percentage) of improved surgical outcome for patients considered marginal for breast conservation surgery prior to therapy for Cohort A is reported below for each treatment arm. Breast conservation surgery (not mastectomy) as the most extensive surgery performed for a patient is considered an improvement in surgical outcome.|At time of surgery up to 18 weeks|Overall Number of Participants Analyzed only includes patients considered marginal for breast conservation surgery prior to therapy.||percentage of improved surgical outcome||95% Confidence Interval|Number
716026|NCT00265759|Secondary|Progression-free Survival (PFS) (Cohort A and B)||assessed up to 10 years||08/2022||||
716027|NCT00265759|Secondary|Toxicity (Cohort A)|Incidence of the most common grade 3+ toxicities reported to be probably, possibly, or definitely related to treatment as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (Cohort A) At each treatment evaluation, the type, severity, and attribution of each adverse event reported will be assessed using the NCI-CTCAE definitions. For each treatment, the percentage of patients who developed a severe (grade 3+) toxicity considered possibly, probably or definitively related to treatment will be determined.|Up to 30 days after drug therapy|||percentage of patients|||Number
716028|NCT00265759|Primary|Anti-tumor Effect in Terms of Pathologic CR (pCR) Rate to Neoadjuvant Chemotherapy (Cohort B)|The primary aim is to assess the anti-tumor effect in terms of pathologic CR rates of neo-adjuvant chemotherapy in patients with T2-T4c, any N, M0 breast cancer (by clinical staging) who are endocrine therapy resistant (that is, their Ki-67 level is >10 after 2-4 week of neo-adjuvant endocrine therapy alone). The pCR rate (percentage) for neo-adjuvant chemotherapy is defined as 100 times the number of eligible patients with no histologic evidence of invasive tumor cells in the surgical breast specimen and the axillary or sentinel lymph nodes divided by the total number of eligible patients who received neo-adjuvant chemotherapy.|Up to 18 weeks|The Overall Number of Participants Analyzed is a subset of the number of patients in Cohort B Arm II: Week 2 Ki67 >10% who switched to neoadjuvant chemotherapy. The remaining number of patients in this arm were not included in this analysis due to decision to either continue with AI therapy or undergo surgery directly.||percentage of patients||95% Confidence Interval|Number
716029|NCT00265759|Primary|Clinical Response (Complete or Partial Response) Rate (Cohort A)|The clinical response rate (percentage) of a given treatment is defined as 100 times the number of eligible patients randomized to that treatment whose disease meets the WHO criteria for complete or partial response prior to surgery divided by the total number of eligible patients randomized to that treatment. For each treatment arm, a 95% binomial confidence interval will be constructed for the true clinical response rate. Complete Response (CR): The disappearance of all known disease based on a comparison between the measurements at baseline and the Week 16 visit. Partial Response (PR): A 50% or greater decrease in the product of the bi-dimensional measurements of the lesion (total tumor size) based on a comparison between the measurements at baseline and the Week 16 visit. In addition there can be no appearance of new lesions or progression of any lesion.|Up to 18 weeks|||percentage of patients||95% Confidence Interval|Number
716030|NCT00265785|Secondary|Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|Patients were assessed for adverse events 4 weeks after starting treatment. Assessments for adverse events continued after every cycle of treatment (every 3 weeks) for the duration of protocol treatment.|Eligible patients who received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.||Participants|||Number
716031|NCT00265785|Secondary|Response (Confirmed and Unconfirmed, Complete and Partial)|Complete response (CR) is complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Normalization of markers and other abnormal lab values. Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration.|Assessed at weeks 7 and 13 while on treatment. After off treatment prior to disease progression, disease assessment takes place every 3 months for a maximum of 3 years.|Eligible and analyzable patients with measurable disease at baseline are included in this measure.||percentage of participants||95% Confidence Interval|Number
716032|NCT00265785|Primary|Overall Survival|Measured from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|0 - 3 years|Eligible and analyzable patients were included in this measure.||months||95% Confidence Interval|Median
716033|NCT00265785|Secondary|Progression-free Survival|Progression is defined as any one or more of the following: 20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline; Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided); Appearance of any new lesion/site; Death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration is defined as globabl deterioration of health status requiring discontinuation of treatment without objective evidence of progression. Progression-free survival is measured from date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.|0 - 3 years|Eligible and analyzable patients were included in this measure.||months||95% Confidence Interval|Median
716034|NCT00265798|Secondary|Overall Survival|Overall survival will be defined as time from the start of treatment until death from any cause.|Up to 5 years|||months||95% Confidence Interval|Median
716035|NCT00265798|Secondary|Progression-free Survival|"Progression-free survival will be defined as time from the start of treatment until progression (documented according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions) or death, whichever comes first.
CT scans for disease reassessment will be obtained pre-therapy and every 8 weeks."|Up to 5 years|||months||95% Confidence Interval|Median
716036|NCT00265798|Primary|Objective Response Rate|"Objective response (complete response (CR)+ partial response (PR)) will be evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR is the disappearance of all target lesions. PR requires at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Computed Tomography (CT) scans for disease reassessment will be obtained pre-therapy and every 8 weeks. In addition to a baseline scan, confirmatory scans will also be obtained 4 weeks following initial documentation of objective response."|Up to 5 years|||percentage of partcipants||95% Confidence Interval|Number
716037|NCT00265850|Secondary|Duration of Tumor Response||Up to 5 years post-treatment||||||
716038|NCT00265850|Secondary|Time to Treatment Failure||Up to 5 years post-treatment||||||
716039|NCT00265850|Secondary|Progression-free Survival (PFS)|PFS will be measured from study entry until first documented progression or death from any cause. Time to event distributions will be estimated using the Kaplan-Meier method. PFS will be compared between Arm A and Arm B.|Up to 5 years post-treatment|All eligible KRAS wild type patients were included in this analysis.||months||95% Confidence Interval|Median
716040|NCT00265850|Primary|Overall Survival|Survival time will be defined as the time from registration to death. Time to event distributions will be estimated using the Kaplan-Meier method. Overall Survival (OS) will be compared between Arm A and Arm B.|Up to 5 years post-treatment|All eligible KRAS wild type patients that began treatment were included in this endpoint.||months||95% Confidence Interval|Median
716041|NCT00265889|Primary|Number of Patients That Experience Pulmonary Toxicity|Pulmonary toxicity are due to side effects that medicinal drugs cause to the lungs.|One year after second transplant|Analysis is per protocol, so includes patients who received treatment||participants|||Number
716042|NCT00265889|Primary|Response Rate|Number of patients that receive a Complete Response (CR), Partial Response (PR)or Progression. CR defined as complete disappearance of all measurable and evaluable disease and no new lesions. PR is defined as >/= 50% decrease in the sum of products of all measurable lesions. Progression is defined as a 50% increase in the sum of products of all measurable lesions.|One year after second transplant|Analysis is per protocol, so includes patients who received both transplants||participants|||Number
716043|NCT00265889|Primary|Progression-free Survival|Outcome is based on the number of patients who were alive without progression or relapse within 1 year. Progression is defined as a 50% increase in the sum of products of all measurable lesions.|one year after second transplant|Analysis is per protocol, so includes patients who received both transplants||participants|||Number
716044|NCT00266032|Post-Hoc|Pearl Index (FDA Criteria)|Following an FDA request another PI evaluation was done for the first year of treatment only and taking into consideration also pregnancies with a conception date within 14 days after end of the study medication. Restricting the analysis to the required first year of treatment, it results in this PI estimation.|Up to one year|FAS||Pregnancies per 100 woman years||95% Confidence Interval|Mean
716045|NCT00266032|Post-Hoc|Number of Unintended Pregnancies Including Pregnancies Occuring Within 14 Days After End of Study Medication.|Pregnancies with conception date during treatment and within 14 days after end of study medication were included.|Up to one year|FAS||Pregnancies|||Number
716046|NCT00266032|Secondary|Days With Scheduled Versus Unscheduled Bleeding|Days with scheduled and unscheduled bleeding were evaluated for extended regimens only. Unscheduled is any bleeding/spotting that occurred while taking active hormones regardless of the duration of intake, unless they occurred after tablet-free interval during days 1-4 of subsequent treatment cycle, or unless they occurred during days 1-7 of first treatment cycle. Scheduled is any bleeding/spotting that occurred during tablet-free interval, regardless of duration of tablet intake, or during next 4 days of subsequent treatment cycle.|Up to one year|FAS (reflecting ITT), all treated subjects, no imputation||Days||Standard Deviation|Mean
716049|NCT00266032|Secondary|Number of Bleeding Days During One Year of Treatment in Subjects With at Least 248 Days of Exposure Normalized to 372 Days|For early dropouts and pregnant subjects with an exposure period of less than 1 year but at least 248 days, the number of bleeding/spotting days was normalized to correspond to a 1-year exposure period.|up to 1 year|FAS (reflecting ITT population), all treated subjects, no imputation||Days||Standard Deviation|Mean
716050|NCT00266032|Secondary|Number of Days With Bleeding Excluding Spotting|The number of bleeding days per volunteer was calculated by summing up all days with bleeding intensity light, normal, or heavy.|up to 1 year|FAS||Days||Standard Deviation|Mean
716051|NCT00266032|Primary|Adjusted Pearl Index|The adjusted Pearl Index was based on pregnancies due to method failures and compliant treatment cycles, i.e. cycle length between 24 and 124 day, pill break not longer than 7 days, and number of pills taken not smaller than 90% of the number of days in that cycle minus 7 days.|Up to 2 years|Full Analysis Set (reflecting ITT population), all treated subjects, no imputation, including switchers to flexible treatment in second year||Pregnancies per 100 woman years||95% Confidence Interval|Mean
716052|NCT00266032|Primary|Number of Unintended Pregnancies Due to Method Failure|Not included in this analysis are pregnancies due to subject failure eg. non-compliance with tablet intake rules.|Up to 2 years|Full Analysis Set (reflecting ITT population), all treated subjects, no imputation, including switchers to flexible treatment in second year||Pregnancies|||Number
716053|NCT00266032|Primary|Pearl Index|The Pearl Index (PI) is defined as the number of pregnancies per 100 woman years. The 2-year PI was obtained by dividing the number of pregnancies that occurred during the two years of treatment by the time (in 100 women years) that the women were under risk of getting pregnant. 95% confidence interval according to European Medicine Agency Note for guidance on clinical investigation of steroid contraceptives in women.|Up to 2 years|Full Analysis Set (reflecting ITT population), all treated subjects, no imputation, including switchers to flexible treatment in second year||Pregnancies per 100 woman years||95% Confidence Interval|Mean
716054|NCT00266032|Primary|Number of Unintended Pregnancies in Yaz Flexible Arm|Pregnancies with conception date within 4 days after end of study medication were regarded as during treatment.|up to 2 years|Full Analysis Set (reflecting ITT population), all treated subjects, no imputation, including switchers to flexible treatment in second year||pregnancies|||Number
716055|NCT00266032|Primary|Number of Days With Bleeding Including Spotting|The number of bleeding days per volunteer was calculated by summing up all days with bleeding intensity spotting or worse. The primary evaluation was the comparison of the flexible extended vs the standard regimen for this primary target variable, which was done for data within the first year of treatment only. As no further comparison or testing was done, no multiplicity issue arose.|up to 1 year|Full Analysis Set (FAS) (reflecting Intention To Treat (ITT) population), all treated subjects with data available, no imputation||days||Standard Deviation|Mean
716056|NCT00266110|Secondary|Generation of Functional Antigen-specific T Cells|Measured by intracellular cytokine staining for Interferon-gamma (INFgamma) and Cluster of Differentiation (CD107) up regulation and tetramer|5-6 years||||||
716057|NCT00266110|Primary|Number of Participants With Response|Response: Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|5-6 years|||Participants|||Count of Participants
716058|NCT00266227|Secondary|Percentage of Retreated Subjects Achieving DAS28-ESR Low Disease at Week 48|The DAS28-ESR score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity (mm), and ESR. DAS28-ESR scores range from 0 - 10. Low disease activity is defined as achieving a DAS28-ESR score of less than or equal to 3.2.|Week 48|Participants from the Intent-to-treat population, that includes all participants randomized to Retreatment, with data available for analyses.||Percentage of participants|||Number
716059|NCT00266227|Secondary|Percentage of Retreated Subjects Achieving DAS28-ESR Remission at Week 48|DAS28-ESR remission was defined as a DAS28-ESR < 2.6|Week 48|Participants from the Intent-to-treat population, that includes all participants randomized to Retreatment, with data available for analyses.||Percentage of participants|||Number
716060|NCT00266227|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) at Week 48 in Retreated Subjects|FACIT-F is a 13-item questionnaire. Patients scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the patient's response to the questions (with the exception of 2 negatively stated), the greater the patient's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the patient's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the patient's health status.|Baseline, Week 48|Participants from the Intent-to-treat population, that includes all randomized participants, with data available for analyses.||Score on a scale||Full Range|Median
716061|NCT00266227|Secondary|Change From Baseline in SF-36 Health Summary Scores at Week 48 in Retreated Subjects|The SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from baseline indicates improvement.|Baseline, Week 48|Participants from the Intent-to-treat population, that includes all participants randomized to Retreatment, with data available for analyses.||Score on a scale||Standard Deviation|Mean
716062|NCT00266227|Secondary|ACRn in Retreated Subjects at Week 48|The ACRn is calculated for each participant by taking the lowest percentage improvement in (1) swollen joint count or (2) tender joint count or (3) the median of the remaining 5 components of the ACR response (participant's assessment of disease activity; participant's global assessment of pain; physician's assessment of disease activity; participant's assessment of physical function; an acute phase reactant value - CRP). A positive ACRn Score indicates an improvement.|Baseline, Week 48|Participants from the Intent-to-treat population, that includes all participants randomized to Retreatment, with data available for analyses.||Score on a scale||Standard Deviation|Mean
716063|NCT00266227|Secondary|Percentage of Retreated Subjects With a Change ≥ 0.3 From Baseline in HAQ-DI at Week 48|The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0(without any difficulty) to 4 (unable to do).HAQ-DI=sum of worst scores in each domain divided by the number of domains answered.|Baseline, Week 48|Participants from the Intent-to-treat population, that includes all participants randomized to Retreatment, with data available for analyses.||Percentage of participants|||Number
716064|NCT00266227|Secondary|Percentage of Retreated Subjects With a Change ≥ 0.22 From Baseline in HAQ-DI at Week 48|The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0(without any difficulty) to 4 (unable to do). HAQ-DI=sum of worst scores in each domain divided by the number of domains answered.|Baseline, Week 48|Participants from the Intent-to-treat population, that includes all participants randomized to Retreatment, with data available for analyses.||Percentage of participants|||Number
716065|NCT00266227|Secondary|Change From Baseline in American College of Rheumatology (ACR) Core Set Component: Erythrocyte Sedimentation (ESR) at Week 48|Blood was collected for Erythrocyte Sedimentation Rate, an inflammatory marker, at Baseline and Week 48. A negative change from baseline indicates improvement.|Baseline, Week 48|Participants from the Intent-to-treat population, that includes all participants randomized to Retreatment, with data available for analyses.||millimeter/hour (mm/hr)||Standard Deviation|Mean
716066|NCT00266227|Secondary|Change From Baseline in American College of Rheumatology (ACR) Core Set Component: C-Reactive Protein at Week 48|Blood was collected for C-Reactive Protein, an inflammatory marker, at Baseline and Week 48. A negative change from baseline indicates improvement.|Baseline, Week 48|Intent-to-treat Population includes all participants randomized to Retreatment.||mg/dL||Standard Deviation|Mean
716067|NCT00266227|Secondary|Change From Baseline in American College of Rheumatology (ACR) Core Set Component: Subject's Assessment of Pain at Week 48|Patients rated their pain at baseline and Week 48 using the Visual Analog Scale (VAS) on a scale of 0 (none) to 100 (unbearable pain). A negative change from baseline indicates improvement.|Baseline, Week 48|Participants from the Intent-to-treat population, that includes all participants randomized to Retreatment with data available for analyses.||millimeter (mm)||Standard Deviation|Mean
716068|NCT00266227|Secondary|Change From Baseline in American College of Rheumatology (ACR) Core Set Component: Physician's Global Assessment of Disease Activity at Week 48|A Rheumatologist or a skilled Arthritis assessor rated the patient's disease activity at baseline and Week 48 using the Visual Analog Scale (VAS) on a scale of 0 (best) to 100 (worse). A negative change from baseline indicates improvement.|Baseline, Week 48|Intent-to-treat population includes all participants randomized to Retreatment.||millimeter (mm)||Standard Deviation|Mean
716069|NCT00266227|Secondary|Change From Baseline in American College of Rheumatology (ACR) Core Set Component: Subject's Global Assessment of Disease Activity at Week 48|Participants rated their disease activity at baseline and Week 48 using the Visual Analog Scale (VAS) on a scale of 0 (best) to 100 (worse). A negative change from baseline indicates improvement.|Baseline, Week 48|Participants from the Intent-to-treat population, that includes all participants randomized to Retreatment, with data available for analyses.||millimeter (mm)||Standard Deviation|Mean
716070|NCT00266227|Secondary|Change From Baseline in American College of Rheumatology (ACR) Core Set Component: Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 48|The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip,and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0(without any difficulty) to 4 (unable to do).HAQ-DI=sum of worst scores in each domain divided by the number of domains answered. A negative change from baseline indicates improvement.|Baseline, Week 48|Participants from the Intent-to-treat population, that includes all participants randomized to Retreatment, with data available for analyses.||Score on a scale||Standard Deviation|Mean
716071|NCT00266227|Secondary|Change From Baseline in American College of Rheumatology (ACR) Core Set Component: Tender Joint Count at Week 48|A Rheumatologist or an skilled arthritis assessor evaluated 68 joints at baseline and at Week 48. A negative change from baseline in the Tender Joint Count indicates improvement.|Baseline, Week 48|Intent-to-treat population includes all participants randomized to Retreatment.||Joint Count||Standard Deviation|Mean
716072|NCT00266227|Secondary|Change From Baseline in American College of Rheumatology (ACR) Core Set Component: Swollen Joint Count at Week 48|A Rheumatologist or an skilled arthritis assessor evaluated 66 joints at baseline and at Week 48. A negative change from baseline in Swollen Joint Count indicates improvement.|Baseline, Week 48|Intent-to-treat population includes all participants randomized to Retreatment.||Joint Count||Standard Deviation|Mean
716073|NCT00266227|Secondary|Percentage of Retreated Subjects With a European League Against Rheumatism (EULAR) Response at Week 48|Change of the Disease Activity Score 28 score from baseline was used to determine EULAR responses of good, moderate, or no response. For a post-baseline score ≤ 3.2, a change from baseline of < -1.2 was a good response, < -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-baseline score > 3.2 to ≤ 5.1, a change from baseline of < -0.6 was a moderate response and ≥ -0.6 was no response. For a post-baseline score > 5.1, a change from baseline < -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-baseline scores > 3.2.|Baseline, Week 48|Intent-to-treat population includes all participants randomized to Retreatment.||Percentage of participants|||Number
716086|NCT00255970|Primary|Change in Probing Depth|This is the distance, measured in millimeters (mm) from the gingival margin to the maximal penetration of the probe tip. The measures were made at baseline and then at 6 months after treatment.|baseline and then at 6 months|||mm||Standard Deviation|Mean
716548|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in Lactate Dehydrogenase, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement||U/L||Full Range|Median
716074|NCT00266227|Secondary|Change From Baseline in Disease Activity Score (DAS28-CRP) at Week 48|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and C-Reactive Protein (CRP) for a total possible score of 2 to 10. Higher values indicate higher disease activity. A negative change from baseline indicates improvement.|Baseline, Week 48|Participants from the Intent-to-treat population that includes all participants randomized to Retreatment with data available for analyses.||Units on a scale||Standard Deviation|Mean
716075|NCT00266227|Secondary|Change From Baseline in the Disease Activity Score Using 28 Joint Counts (DAS28-ESR) at Week 48|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 2 to 10. Higher values indicate higher disease activity. A negative change from baseline indicates improvement.|48 weeks|Participants from the Intent-to-treat population, that includes all participants randomized to Retreatment, with data available for analyses.||Units on a scale||Standard Deviation|Mean
716076|NCT00266227|Secondary|Retreated Subjects With American College of Rheumatology 50% (ACR50) Response and American College of Rheumatology 70% (ACR70) Response at Week 48 Relative to Baseline|ACR50 or ACR70 response was defined as a ≥ 50% or 70% improvement compared with baseline in both tender joint count (TJC) [68 joints] and swollen joint count (SJC) [66 joints] as well as a ≥ 50% or 70% improvement in three of five additional measurements: 1) Physician's Global Assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity]; 2) Patient's Global Assessment of Disease Activity [visual analog scale: 0=no disease activity to 100=maximum disease activity]; 3) Patient's Assessment of Pain [visual analog scale: 0=no pain to 100=unbearable pain]; 4) Health Assessment Questionnaire [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do] and 5) erythrocyte sedimentation rate.|Baseline, Week 48|Intent-to-treat population includes all participants randomized to Retreatment.||Participants|||Number
716077|NCT00266227|Primary|Retreated Subjects With an American College of Rheumatology 20% (ACR20) Response at Week 48 Relative to Baseline|ACR20 response was defined as a ≥ 20% improvement compared with baseline in both tender joint count (TJC) [68 joints] and swollen joint count (SJC) [66 joints] as well as a ≥ 20% improvement in three of five additional measurements: 1) Physician's Global Assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity]; 2) Patient's Global Assessment of Disease Activity [visual analog scale: 0=no disease activity to 100=maximum disease activity]; 3) Patient's Assessment of Pain [visual analog scale: 0=no pain to 100=unbearable pain]; 4) Health Assessment Questionnaire [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do] and 5) erythrocyte sedimentation rate.|48 Weeks|Intent-to-treat population includes all participants randomized to Retreatment.||Participants|||Number
716078|NCT00266279|Secondary|Qualitative and Quantitative Toxicity|The most common toxicities were grades 1 or 2 fatigue and anemia .|Every two 28 day treatment cycles||12/2018||||
716079|NCT00266279|Primary|Overall Response Rate|"Among the 15 patients treated, 2 (13%) achieved partial response (PR), and 5 (33%) achieved stable disease (SD), for a Overall Response Rate (ORR) of 46% measured by RECIST criteria.
Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Overall Response Rate (ORR)=PR+CR."|Every two 28 day treatment cycles until subject no longer on treatment due to disease progression|||Participants|||Number
716080|NCT00255970|Secondary|Mobility Index|"Tooth mobility was recorded using Miller's Index:
— up to 1 mm of movement in a horizontal direction
— greater than 1 mm of movement in a horizontal direction
— excessive horizontal movement and vertical movement. Manual evaluation of mobility was carried out clinically using the handles of two instruments to move the teeth buccally and lingually and note their movement."|6 months|A power analysis, prior to data collection, determined that a minimum of 18 in each arm would be needed for this study. The power analysis had been computed for a threshold of 0.05 with a power of 0.8.||Units on a scale||Standard Deviation|Mean
716081|NCT00255970|Secondary|Bleeding on Probing|"The variable measured the presence of bleeding when the osseus defect was probed. The presence and character of gingival bleeding will be determined by gently probing to the base of the pockets.
0 - No bleeding.
1 - Bleeding when probing."|6 months|The a priori power analysis had been designed with an effect size based on historical data. Thus, a minimal sample size of 34 patients would be necessary to determine if there was a true difference between groups, α =.05, power= 0.8. This number was then rounded to 40 patients, 20/ group (DFDBA and Regenafil).||Units on a scale||Standard Deviation|Mean
716082|NCT00255970|Secondary|Plaque Index|"0- No plaque
A film of plaque adhering to gingival margin & adjacent area of tooth
Moderate accumulation of soft deposits, visible with the naked eye
Abundance of soft matter Each gingival region of the individual tooth will be scored 0-3 The scores from the 6 areas of the tooth are averaged to give the plaque index for the tooth."|6 months|The number of participants to be analyzed was based on a power analysis, using a threshold of 0.05 with a power of 0.8. The power analysis indicated 18 participants were needed in each arm||Categorical index score||Standard Deviation|Mean
716083|NCT00255970|Secondary|Gingival Index|"Scores:
0 Normal gingiva
Mild inflammation
Moderate inflammation
Severe inflammation Gingival units (buccal, lingual, mesiobuccal, distobuccal, mesiolingual, and distolingual) of each tooth were scored 0-3. Scores from the 6 areas of the tooth were added and divided by 6 to give the gingival index for the entire tooth."|6 months|As stated in the protocol, the power analysis (threshold=0.05, power>0.8) noted 18 subjects would be needed per group.||Units on a scale||Standard Deviation|Mean
716084|NCT00255970|Primary|Recession|CEJ to gingival margin (GM). GM coronal to the CEJ were scored as a negative number.|6 months|The number of participants to be analyzed was based on a power analysis, using a threshold of 0.05 with a power of 0.8. The power analysis indicated 18 participants were needed in each arm||mm||Standard Deviation|Mean
716087|NCT00256204|Secondary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) Score From Baseline to Last Observed Value in the Placebo Phase|Subjects were assessed according to the United Parkinson's Disease Rating Scale UPDRS,(version 3;) Parts I and II are historical data and are designed to rate mentation, behavior and mood; Part III is done as a motor examination at the time of a visit. The UPDRS measures patient status on a scale 0, which is normal or none, to 4, which is severe or the worst scenario.|36 weeks|||Scores on a scale||Standard Deviation|Mean
716088|NCT00256204|Primary|Change in Total Unified Parkinson's Disease Rating Scale (UPDRS) Score From Baseline|The primary efficacy endpoint was defined as the change in Total UPDRS from Baseline. Subjects were assessed according to the United Parkinson's Disease Rating Scale (UPDRS,(version 3;) Parts I and II are historical data and are designed to rate mentation, behavior and mood; Part III is done as a motor examination at the time of a visit. The UPDRS measures patient status on a scale 0, which is normal or none, to 4, which is severe or the worst scenario.|12w, 24w, 36w, 42w, 48w, 54w, 60w, 66w, 72w|||Scores on a scale||Standard Deviation|Mean
716089|NCT00256243|Secondary|Microscopic Pathological Response Rate|pathological response rate: No evidence of microscopic invasive tumor at the primary tumor site in the surgical specimen.|5 years|Of the 48 study participants, one patient refused preoperative but received standard adjuvant AC followed by docetaxel (without trastuzumab), relapsed, and died. Therefore, 47 participants were analyzed.||Percent|||Number
716090|NCT00256243|Primary|Clinical Response Rate|Clinical response (CR): Normal breast on physical exam. No mass, no thickening, no erythema, no peau d’orange.|5 years|Of the 48 study participants, one patient refused preoperative but received standard adjuvant AC followed by docetaxel (without trastuzumab), relapsed, and died. Therefore, 47 participants were analyzed.||Percent by best modality|||Number
716091|NCT00256295|Secondary|Overall Survival and Time to Treatment Failure||5 years|No subject data were analyzed; therefore, data cannot be summarized for inclusion in these data tables.|||||
716092|NCT00256295|Secondary|Frequency and Severity of Toxicities||5 years|No subject data were analyzed; therefore, data cannot be summarized for inclusion in these data tables.|||||
716093|NCT00256295|Primary|Overall Response Rate (Complete and Partial Response)|"Complete Response (CR): Complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Normalization of markers and other abnormal lab values. All disease must be assessed using the same techniques as baseline.
Partial Response (PR): Applies only to patients with at least one measurable lesion. Greater than or equal to 30% decrease under baseline of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. All target measurable lesions must be assessed using the same techniques as baseline."|5 years|No subject data were analyzed; therefore, data cannot be summarized for inclusion in these data tables.|||||
716094|NCT00256698|Secondary|Overall Survival (OS)|Overall survival is equivalent to time to death. Time from randomisation until the date of death|All deaths occurring between randomisation and data cut-off on 30th April 2009 are included.|||months||Full Range|Median
716095|NCT00256698|Secondary|Time to Treatment Failure (TTF)|Time from randomisation until the date of discontinuation of randomised treatment for any reason|From randomisation until data cut-off on 30th April 2009|||months||Full Range|Median
716096|NCT00256698|Secondary|Duration of Clinical Benefit (DoCB)|Median time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who are clinical benefit responders|RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009|||months||Full Range|Median
716097|NCT00256698|Secondary|Duration of Response (DoR)|Median time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who are objective responders|RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009|||months||Full Range|Median
716098|NCT00256698|Secondary|Percentage of Clinical Benefit Rate (CBR) Responders|No. of patients who were clinical benefit responders over the no. of randomised patients x100. A clinical benefit responder = a patient whose best response is CR, PR or SD>=24 weeks (where a best response of SD = no new lesions and for existing lesions; neither suffient shrinkage to count as PR nor sufficient growth to count as progression)|RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009|||Percentage of participants|||Number
716099|NCT00256698|Secondary|Percentage of Evaluable Participants With Objective Response Rate (ORR)|No. of patients who were objective responders over the no. of patients evaluable for response x100. An objective responder = a patient whose best response is either CR (disappearance of all lesions) or PR (>= 30% shrinkage in the sum of the longest diamemeters of the measurable lesions + no new lesions + no progression of non-measurable lesions)|RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009|||Percentage of evaluable participants|||Number
716100|NCT00256698|Primary|Time to Progression (TTP)|"RECIST (Response Evaluation Criteria in Solid Tumours) assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009. TTP, time in months to worsen 'progression' according to RECIST criteria. (RECIST is a set of published rules that define when cancer patients improve respond, stay the same stableor worsen progression during treatments."|RECIST assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009|||months||Full Range|Median
716101|NCT00256724|Secondary|Quantity of Fluid Administration||during 10 minutes of device use|||mL||Standard Deviation|Mean
716102|NCT00256724|Primary|Rise in Systolic Blood Pressure Over the First 10 Minutes of Use Compared to Baseline||every 2 minutes during 10 minutes of device use|||mm Hg||Standard Deviation|Mean
716148|NCT00256984|Secondary|PAC QOL Patient Assessment of Constipation (Overall)|PAC-QOL is Patient Assessment of Constipation, Quality of Life. The instrument consists of 28 questions on a 0-4 scale. A lower score indicates better quality of life. The score is a number without units.Change from baseline in patient assessment of constipation in quality of life as measured by the PAC QOL instrument score. The questions are designed to measure the impact constipation has had on daily life during the week prior to the subject visit. Sizing was consistent with the primary outcome; analysis was per-protocol|Baseline, 12 months|Sizing consistent with primary outcome; analysis was Intent-to-Treat||units on a scale||Standard Deviation|Mean
716570|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest and Lowest Values in Standing Systolic BP During Phase 3||Baseline, During Phase 3 (for highest/lowest values), Week 52|Participants in Phase 3 Safety Sample with measurement; Week 52 LOCF||mm Hg||Full Range|Median
716285|NCT00258349|Secondary|Overall Survival|Overall survival is defined as time from registration to death from any cause. Patients who were alive were censored as the last date of known alive.|Survival was assessed every 3 months for first 2 years from protocol entry, then every 6 months until 3 years from study entry|10 eligible HER2-positive (by central review) patients||months||95% Confidence Interval|Median
716146|NCT00256984|Secondary|SF-12 QOL Change (Mental Component) at 12 Months From Baseline|SF 12 change from baseline, mental component. The SF-12 is a validated 12 question quality-of-life questionnaire. The SF-12 extracts 12 items from the SF-36 questionnaire in two six-item subscales, PCS (physical functioning) and MCS (emotional functioning). The SF-36 scores range from 0 (maximum impairment) to 100 (no impairment), the SF-12 scores range from 10 (maximum impairment) to 70 (no impairment). For this study, the endpoint is the percentage of change from baseline over 12 months post procedure.|Baseline, 12 months|||units on a scale||Standard Deviation|Mean
716147|NCT00256984|Secondary|SF-12 QOL Change From Baseline (Physical Component)at 12 Months|The SF-12 is a validated 12 question quality-of-life questionnaire. The SF-12 extracts 12 items from the SF-36 questionnaire in two six-item subscales, PCS (physical functioning) and MCS (emotional functioning). The SF-12 scores can range from 10 (maximum impairment) to 70 (no impairment). For this study, the endpoint is the percentage of change from baseline over 12 months post procedure.|Baseline, 12 Months|||units on a scale||Standard Deviation|Mean
716571|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest and Lowest Values in Sitting Heart Rate During Phase 3||Baseline, During Phase 3 (for highest/lowest values), Week 52|Participants in Phase 3 Safety Sample with measurement; Week 52 LOCF||beats per minute ?||Full Range|Median
716149|NCT00256984|Secondary|Percentage of Change in ODS Symptom Composite Score From Baseline at 6 Months (0 is Worst Score, 24 is Best Score)|The primary endpoint used to assess effectiveness of STARR for treatment of ODS was the percentage of change in total ODS symptom composite score (0=worst, 24=best) 1 year after completion of the procedure.|Baseline, 6 months post procedure|||percentage of change||Standard Deviation|Mean
716150|NCT00256984|Secondary|Maximum Change in Subject-reported Assessment of Symptom Severity and Frequency (PAC SYM).|Assessed as patient-reported assessment of symptom severity and frequency (PAC-SYM)associated with constipation. Patient response options are absent, mild, moderate, severe, and very severe.12 questions relate to severity, 8 questions relate to frequency of symptoms. The lower the score, the less severe the symptoms. Sizing consistent with primary outcome; analysis was per-protocol.|Baseline, 6 months|||units on a scale||Standard Deviation|Mean
716151|NCT00256984|Secondary|Percentage of Change in ODS Symptom Composite Score From Baseline at 1 Month Post Procedure|Percentage of change in Obstructive Defecation Syndrome (ODS) symptom composite score from baseline at 1 month post procedure. This score is based on a series of questions designed to understand the extent ODS effects an individual's daily lifestyle (0 is worst score, 24 is best score). Sizing consistent with primary outcome; analysis was per-protocol.|Baseline, 1 month post procedure|||percentage of change||Standard Deviation|Mean
716152|NCT00256984|Primary|Percentage of Change (Reduction) in Total ODS Symptom Composite Score From Baseline to One Year Post Procedure|The primary endpoint used to assess effectiveness of STARR for treatment of ODS was the percentage of change in total ODS symptom composite score (0=worst, 24=best) 1 year after completion of the procedure.|one year from Baseline|Per protocol||percentage of change||Standard Deviation|Mean
716153|NCT00256997|Secondary|Change From Baseline in Personal and Social Performance Scale (PSP) Total Score at Month 24|The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty).|Baseline and End of Study (Month 24 or Early Termination [ET])|ITT population. Here 'N' signifies number of participants evaluated for this outcome measure and 'n' signifies number of participants who were evaluated for this outcome measure at given timepoint. This study was stopped due to futility; care must be exercised in any interpretation of utilization of these data.||Units on a scale||Standard Error|Mean
716154|NCT00256997|Secondary|Change From Baseline in Assessment of Quality of Life (AQoL) Score at Month 24|"AQoL is defined as an Australian-developed participant delivered quality of life (QoL) instrument consisting of 15-questions in 5 scales measuring illness, independence, social relationships, physical senses and psychological well-being. Each of the 5 scales is calculated based on the answers to 3 questions. Each question is given an answer dependent utility score (0 [worst] to 1 [best] and then these scores are combined using a multiplicative model to get the normalized scale score value, each scale ranging between 0.0 (representing death) and 1.0 (representing full health). The scores for independent living, social relationships, physical senses and psychological well-being are combined to obtain the QoL utility score which refers to the value of a health state to the respondent where the lower boundary is -0.04 (representing QoL state worse than death), 0.00 (death equivalent QoL state) and to 1.00 (best possible QoL state)”."|Baseline and Month 24|ITT population. Here 'N' signifies number of participants evaluated for this outcome measure and 'n' signifies number of participants who were evaluated for this outcome measure at given timepoint. This study was stopped due to futility; care must be exercised in any interpretation of utilization of these data.||Units on a scale||Standard Deviation|Mean
716155|NCT00256997|Secondary|Number of Participants With Response to Resource Utilization Questionnaire (RUQ)|This questionnaire included questions asked to participants about any hospitalizations, visits to the emergency room or any other psychiatric treatment received in the previous month. Also the participants and/or primary health care contact or caregiver (or other modality to obtain accurate information) were telephoned on a monthly basis (1 month post Visit 2 through to end of study [Visit 6, Month 24]) by a member of the investigational staff and the resource utilization assessment was conducted over the phone.|Baseline up to Month 24|ITT population included all participants who received medication with at least one post-baseline effectiveness measure. This study was stopped due to futility; care must be exercised in any interpretation of utilization of these data.||Participants|||Number
716156|NCT00256997|Secondary|Number of Participants With Clinical Global Impression of Change (CGI-C)|The CGI-C is a assessment of change in global clinical status, defined as a sense of well-being and ability to function in daily activities. CGI-C scores range from 1 (very much improved) through to 7 (very much worse). Higher scores indicate worsening.|End of Study (Month 24 or Early Withdrawal [EW])|ITT population included all participants who received medication with at least one post-baseline effectiveness measure. Here, 'N' signifies number of participants evaluated for this outcome measure. This study was stopped due to futility; care must be exercised in any interpretation of utilization of these data.||Participants|||Number
716157|NCT00256997|Secondary|Number of Participants With Clinical Global Impression of Severity (CGI-S)|The CGI-S rating scale is used to rate the severity of a patient's psychotic condition on a 7-point scale. It is rated as follows: 1=Normal, not at all ill, 2=Borderline mentally ill, 3=Mildly ill, 4=Moderately ill, 5=Markedly ill, 6=Severely ill, and 7=Among the most extremely ill. Higher scores indicate worsening.|Baseline and End of Study (Month 24 or Early Withdrawal [EW])|ITT population. Here, 'N' signifies number of participants evaluated for this outcome measure. 'n' signifies number of participants who were evaluated for this outcome measure at given timepoint. This study was stopped due to futility; care must be exercised in any interpretation of utilization of these data.||participants|||Number
716185|NCT00257192|Secondary|Change From Baseline in Child Health Questionnaire (CHQ)|CHQ: 50-item, 15 subscale parent or legal guardian assessed instrument of child’s physical, emotional, social well-being, and relative burden of disease on the parents; rated on Likert-type scale: range 0 to 100; higher scores indicate a more positive health status. Global indicators for Physical Health and Psychosocial Health are weighted composites derived from subscale items using scoring algorithms (transformed scores); range 0 to 100: higher scores indicate more positive health status.|Baseline, Week 6, ET|ITT. ET includes observations from visits not within windowing criteria. LOCF imputation used for Week 6 LOCF timepoint.||scores on a scale||Standard Deviation|Mean
716158|NCT00256997|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Total Score at Month 24|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210, higher scores indicate worsening.|Baseline and Month 24|ITT population. Here, 'N' signifies number of participants evaluated for this outcome measure. 'n' signifies number of participants who were evaluated for this outcome measure at given timepoint. This study was stopped due to futility; care must be exercised in any interpretation of utilization of these data.||Units on a scale||Standard Deviation|Mean
716159|NCT00256997|Secondary|Time in Symptomatic (Having Symptoms) Remission|Time in symptomatic (having symptoms) remission for participants on risperidone was compared with those on oral atypical medication and was calculated over the entire trial duration.|Baseline up to Month 24|Data for this outcome was not computed as it was not defined in terms of the formula for calculation and thus was not included in analysis plan.|||||
716160|NCT00256997|Secondary|Time to First Clinical Exacerbation|Time to first clinical exacerbation was calculated over the entire trial duration wherein clinical exacerbation is defined as hospitalization because of participant’s schizophrenia or requiring change from current antipsychotic or initiation of an adjunctive antipsychotic, 2-point worsening in CGI-S or emergency room visit, deliberate self-injury, emergence of clinically significant suicidal ideation, utilization of treatment team services, violent behavior, requiring an increase in dose of existing antipsychotic as a result of poor symptom control.|Baseline up to Month 24|ITT population included all participants who received medication with at least one post-baseline effectiveness measure. Here, 'N' signifies number of participants evaluated for this outcome measure. This study was stopped due to futility; care must be exercised in any interpretation of utilization of these data.||Months||Standard Error|Mean
716161|NCT00256997|Secondary|Percentage of Participants Who Experienced a Clinical Exacerbation|Clinical exacerbation is defined as hospitalization because of participant’s schizophrenia or requiring change from current antipsychotic or initiation of an adjunctive antipsychotic, 2-point worsening in CGI-S or emergency room visit, deliberate self-injury, emergence of clinically significant suicidal ideation, utilization of treatment team services, violent behavior, requiring an increase in dose of existing antipsychotic as a result of poor symptom control.|Baseline up to Month 24|ITT population included all participants who received medication with at least one post-baseline effectiveness measure. This study was stopped due to futility; care must be exercised in any interpretation of utilization of these data.||Percentage of participants|||Number
716162|NCT00256997|Primary|Percentage of Participants Who Experienced a Clinical Exacerbation From Month 3 Post-Randomization|Clinical exacerbation is defined as hospitalization because of participant’s schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, delusions, hallucinations, and self withdrawal) or requiring change from current antipsychotic or initiation of adjunctive antipsychotic, 2-point worsening in Clinical Global Impression of Severity (CGI-S) or emergency room visit, deliberate self-injury, emergence of clinically significant suicidal ideation, utilization of treatment team services, violent behavior, requiring an increase in dose of existing antipsychotic as a result of poor symptom control.|Month 3 up to Month 24|Intent-to-treat (ITT) population included all participants who received medication with at least one post-baseline effectiveness measure. This study was stopped due to futility; care must be exercised in any interpretation of utilization of these data.||Percentage of participants|||Number
716163|NCT00257010|Secondary|Number of Headaches With Vomiting|Occurrence and intensity of vomiting post-dose of study medication. Vomiting is an act or instance of disgorging the contents of the stomach through the mouth also called emesis.|Baseline (after onset of migraine headache pain and before treatment), 2 hours and 24 hours post-dose|Intent-to-Treat (ITT) population is defined as all enrolled participants who took at least one dose of study medication and for whom at least one post-dose efficacy assessment was available.||Number of headaches with vomiting|Participants||Number
716164|NCT00257010|Secondary|Number of Headaches With Nausea|Occurrence and intensity of nausea post-dose of study medication. Nausea is a feeling of sickness characterized by gastrointestinal distress and an urge to vomit.|Baseline (after onset of migraine headache pain and before treatment), 2 hours and 24 hours post-dose|Intent-to-Treat (ITT) population is defined as all enrolled participants who took at least one dose of study medication and for whom at least one post-dose efficacy assessment was available.||Number of headaches with nausea|Participants||Number
716165|NCT00257010|Secondary|Number of Headaches With Phonophobia|Occurrence and intensity of phonophobia post-dose of study medication. Phonophobia is an abnormal sensitivity to or intolerance of noise.|Baseline (after onset of migraine headache pain and before treatment), 2 hours and 24 hours post-dose|Intent-to-Treat (ITT) population is defined as all enrolled participants who took at least one dose of study medication and for whom at least one post-dose efficacy assessment was available.||Number of headaches with phonophobia|Participants||Number
716166|NCT00257010|Secondary|Number of Headaches With Photophobia|Occurrence and intensity of photophobia post-dose of study medication. Photophobia is an abnormal sensitivity to or intolerance of light, especially by the eyes.|Baseline (after onset of migraine headache pain and before treatment), 2 hours and 24 hours post-dose|Intent-to-Treat (ITT) population is defined as all enrolled participants who took at least one dose of study medication and for whom at least one post-dose efficacy assessment was available.||Number of headaches with photophobia|Participants||Number
716167|NCT00257010|Secondary|Number of Headaches Achieving Pain Relief at 2 and 24 Hours Post-Dose|Headache pain relief is defined as a decrease in baseline pain intensity from either severe or moderate intensity to mild or no pain, without the use of supplemental pain medication and/or anti-emetic medication (including a second dose of study medication) within 2 (or 24) hours of first dose of study medication. Sustained pain relief is defined as pain relief at 2 and 24 hours without the use of supplemental pain medication and/or anti-emetic medication (including a second dose of study medication) within 24 hours.|2 hours and 24 hours post-dose|Intent-to-Treat (ITT) population is defined as all enrolled participants who took at least one dose of study medication and for whom at least one post-dose efficacy assessment was available.||Number of headaches|Participants||Number
716168|NCT00257010|Primary|Number of Pain Free Headaches at 2 and 24 Hours Post-Dose|Headache pain free is defined as a decrease in baseline pain intensity from severe, moderate or mild to no pain, without the use of supplemental pain medication and/or anti-emetic medication (including a second dose of study medication) within 2 (or 24) hours of first dose of study medication. Sustained pain free is defined as pain free at 2 and 24 hours without the use of supplemental pain medication and/or anti-emetic medication (including a second dose of study medication) within 24 hours.|2 hours and 24 hours post-dose|Intent-to-Treat (ITT) population is defined as all enrolled participants who took at least one dose of study medication and for whom at least one post-dose efficacy assessment was available.||Number of headaches|Participants||Number
716169|NCT00257166|Secondary|Clinical Global Impression - Improvement (CGI-I) Score|CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale.|Week 1, 2, 3, 4|ITT population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were available for this measure at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
716170|NCT00257166|Secondary|Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 1, 2, 3 and 4|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill).|Baseline, Week 1, 2, 3, 4|ITT population. Here, ‘n’ signifies those participants who were available for this measure at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
716171|NCT00257166|Secondary|Change From Baseline in Young Mania Rating Scale (YMRS) Score at Week 1, 2 and 3|YMRS: an 11-item scale that measured the severity of manic episodes. Four items were rated on a scale from 0 (symptom absent) to 8 (symptom extremely severe). The remaining items were rated on a scale from 0 (symptom absent) to 4 (symptom extremely severe). YMRS total score ranged from 0 to 60, higher score indicated higher severity of mania.|Baseline, Week 1, 2, 3|ITT population. ‘N’ (number of participants analyzed) signifies those participants who were available for this measure. ‘n’ signifies those participants who were available for this measure at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
716172|NCT00257166|Primary|Change From Baseline in Young Mania Rating Scale (YMRS) Score at Week 4|YMRS: an 11-item scale that measured the severity of manic episodes. Four items were rated on a scale from 0 (symptom absent) to 8 (symptom extremely severe). The remaining items were rated on a scale from 0 (symptom absent) to 4 (symptom extremely severe). YMRS total score ranged from 0 to 60, higher score indicated higher severity of mania.|Baseline, Week 4|Intent-to-treat (ITT): all randomized participants who had baseline measurements, took at least (>=) 1 dose of study medication (ziprasidone or placebo) and had >=1 post-baseline visit. Here, ‘n’ signifies those participants who were available for this measure at given time points for each group.||units on a scale||Standard Deviation|Mean
716173|NCT00257192|Secondary|Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance|School placement questionnaire: parent or legal guardian assessed questionnaire to determine whether the child is currently enrolled in school (or planned to be enrolled if on school holiday like summer break), whether attending regularly if enrolled, and how well the child is doing overall in school. Questions were modified from those used in the National Institute of Mental Health (NIMH) funded Treatment of Early Onset Schizophrenia Spectrum (TEOSS) study. Results determine whether subjects are currently attending school and qualitatively describe how well they are doing in school.|Baseline, Week 2, Week 6, ET|ITT; N=number of subjects analyzable for School Placement Questionnaire; (n)=number of subjects with analyzable data at baseline and post-baseline observation for ziprasidone and placebo, respectively. ET includes observations from visits not within windowing criteria. LOCF imputation used for Week 6 LOCF timepoint.||participants|||Number
716174|NCT00257192|Secondary|Number of Subjects Per Response on the School Placement Questionnaire: School Attendance|School placement questionnaire: parent or legal guardian assessed questionnaire to determine whether the child is currently enrolled in school (or planned to be enrolled if on school holiday like summer break), whether attending regularly if enrolled, and how well the child is doing overall in school. Questions were modified from those used in the National Institute of Mental Health (NIMH) funded Treatment of Early Onset Schizophrenia Spectrum (TEOSS) study. Results determine whether subjects are currently attending school and qualitatively describe how well they are doing in school.|Baseline, Week 2, Week 6, ET|ITT; N=number of subjects analyzable for School Placement Questionnaire; (n)=number of subjects with analyzable data at baseline and post-baseline observation for ziprasidone and placebo, respectively. ET includes observations from visits not within windowing criteria. LOCF imputation used for Week 6 LOCF timepoint.||participants|||Number
716175|NCT00257192|Secondary|Number of Subjects Per Response on the School Placement Questionnaire: School Situation|School placement questionnaire: parent or legal guardian assessed questionnaire to determine whether the child is currently enrolled in school (or planned to be enrolled if on school holiday like summer break), whether attending regularly if enrolled, and how well the child is doing overall in school. Questions were modified from those used in the National Institute of Mental Health (NIMH) funded Treatment of Early Onset Schizophrenia Spectrum (TEOSS) study. Results determine whether subjects are currently attending school and qualitatively describe how well they are doing in school.|Baseline, Week 2, Week 6, ET|ITT; N=number of subjects analyzable for School Placement Questionnaire; (n)=number of subjects with analyzable data at baseline and post-baseline observation for ziprasidone and placebo, respectively. ET includes observations from visits not within windowing criteria. LOCF imputation used for Week 6 LOCF timepoint.||participants|||Number
716176|NCT00257192|Secondary|Change From Baseline in Movement Disorder Scales: Abnormal Involuntary Movement Scale (AIMS) Movement Cluster Score|AIMS: clinician rated 12-item scale to rate 7 body areas and global judgments on the severity of abnormal movements, incapacitation and subject's awareness of abnormal movements. Items 1 to 10 scored 0 (none) to 4 (severe) (total possible score 0 to 40; higher score indicates greater severity); items 11 to 14 are No or Yes response to dental status and sleep movements. Only the sum of the first 7 items to be analyzed (AIMS Movement Cluster score). Total score 0 to 28; higher score indicates greater severity.|Baseline, Week 1 through Week 6|ITT; N=number of subjects with analyzable data at baseline; (n)=number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. LOCF imputation used for Week 6 LOCF timepoint.||scores on a scale||Standard Deviation|Mean
716177|NCT00257192|Secondary|Change From Baseline in Movement Disorder Scales: Barnes Akathisia Rating Scale (BAS) Global Clinical Assessment Item|BAS: clinician rated scale to assess akathisia to determine the degree of subjective restlessness and distress associated with restlessness. First 3 items (Objective, Subjective, and Distress related to restlessness) rated on a 4-point scale with range 0 (no symptoms) to 3 (increased severity of symptoms). Item 4 Global Clinical Assessment of Akathisia rated on a 6-point scale range 0 (no symptoms) to 5 (increased severity of symptoms); higher score indicates increased severity. All rating are anchored. Only the Global Clinical Assessment of Akathisia was to be analyzed.|Baseline, Week 1 through Week 6|ITT; N=number of subjects with analyzable data at baseline; (n)= number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. LOCF imputation used for Week 6 LOCF timepoint.||scores on a scale||Standard Deviation|Mean
716178|NCT00257192|Secondary|Change From Baseline in Movement Disorder Scales: Simpson-Angus Rating Scale (SARS)|SARS: 10-item clinician rated instrument to assess parkinsonian symptoms (7 items) and related extrapyramidal side effects (3 items): gait, arm dropping, shoulder shaking, elbow rigidity, leg pendulousness, glabellar tap, tremor, and salivation. Head dropping (modified SARS item 7) substituted for head rotation. Anchored 5-point scale: range 0 (absence of condition, normal) to 4 (most extreme form of condition). Total score is sum of individual item scores (range 0 to 40); higher score indicates more affected.|Baseline, Week 1 through Week 6|ITT; N=number of subjects with analyzable data at baseline; (n)= number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. LOCF imputation used for Week 6 LOCF timepoint.||scores on a scale||Standard Deviation|Mean
716179|NCT00257192|Secondary|Change From Baseline in CNS Vital Signs Cognitive Test Battery: Neurocognitive Index|A computerized subject-administered test battery with subtests for verbal and visual memory, processing speed, nonverbal reasoning, executive functioning, working memory, and sustained attention. A computerized 7-point sedation item (0 [not sleepy] to 10 [very sleepy]) was completed prior to test battery. The Neurocognitive index score was derived from subtest scores per an algorithm. The index score and subtest scores assessed the subject’s changes in cognition. Scores were rated as above average (score >109), average (90 to 109), below average (80 to 89), or well below average (70 to 79).|Baseline, Week 6, ET|ITT; N=number of subjects with analyzable data at baseline; (n)= number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. ET includes observations from visits not within windowing criteria. LOCF imputation used for Week 6 LOCF timepoint (last post-baseline non-missing visit).||scores on a scale||Standard Deviation|Mean
716180|NCT00257192|Secondary|Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales|A computerized subject-administered test battery with subtests for verbal and visual memory, processing speed, nonverbal reasoning, executive functioning, working memory, and sustained attention. A computerized 7-point sedation item (0 [not sleepy] to 10 [very sleepy]) was completed prior to test battery. The Neurocognitive index score was derived from subtest scores per an algorithm. The index score and subtest scores assessed the subject’s changes in cognition. Scores were rated as above average (score >109), average (90 to 109), below average (80 to 89), or well below average (70 to 79).|Baseline, Week 6, ET|ITT; N=number of subjects with analyzable data at baseline; (n)= number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. ET includes observations from visits not within windowing criteria. LOCF imputation used for Week 6 LOCF timepoint (last post-baseline non-missing visit).||scores on a scale||Standard Deviation|Mean
716181|NCT00257192|Secondary|Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Impaired Schoolwork Item 1|Clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses resolved by using most impaired rating given by valid informant. Impaired Schoolwork (Item 1) assesses school function for the subgroup of subjects reported to be in school. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment).|Baseline, Week 2, Week 6|ITT; N=number of subjects with analyzable data at baseline; (n)=number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. LOCF imputation used for Week 6 LOCF timepoint.||scores on a scale||Standard Deviation|Mean
716182|NCT00257192|Secondary|Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Suicide Ideation Item 13|CDRS-R: clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Suicide Ideation (Item 13) detects changes in suicidality over time. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment).|Baseline, Week 1 through Week 6|ITT; N=number of subjects with analyzable data at baseline; (n)=number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. LOCF imputation used for Week 6 LOCF timepoint.||scores on a scale||Standard Deviation|Mean
716183|NCT00257192|Secondary|Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Total Score|CDRS-R: clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment.|Baseline, Week 1 through Week 6|ITT; N=number of subjects with analyzable data at baseline; (n)=number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. LOCF imputation used for Week 6 LOCF timepoint.||scores on a scale||Standard Deviation|Mean
716184|NCT00257192|Secondary|Change From Baseline in Children's Problem Behavior and Aggression Questionnaire (CPBAQ) Total Score|CPBAQ: 19-item parent or legal guardian completed questionnaire to rate the child's verbal (such as yelling or cursing) and physical aggression (such a fighting with peers or being cruel to an animal) during the past week. Behavior was rated on a 4-point scale; range 0 (behavior did not occur or was not a problem) to 3 (behavior occurred a lot or was severe problem). Total score range 0 to 57; higher scores indicate a greater frequency and severity of aggression.|Baseline, Week 1 through Week 6|ITT; N=number of subjects with analyzable data at baseline; (n)= number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. LOCF imputation used for Week 6 LOCF timepoint.||scores on a scale||Standard Deviation|Mean
716186|NCT00257192|Secondary|Change From Baseline in Children's Global Assessment Scale (CGAS)|CGAS: clinician-rated global assessment item for children based on symptoms and social functioning in home, school, and community settings. Scores on this single item range from 1 to 100 (higher levels indicate greater health) with descriptive anchors for every 10-point interval. Scores above 70 on this scale are considered within the “normal” range; lower score indicates need for increased supervision.|Baseline, Week 2, Week 4, Week 6, Early termination (ET)|ITT; (n)=number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. ET includes observations from visits not within windowing criteria. Last observation carried forward [LOCF] imputation used for Week 6 LOCF timepoint.||scores on a scale||Standard Deviation|Mean
716187|NCT00257192|Secondary|Clinical Global Impression of Improvement (CGI-I) Score at Week 6|CGI-I: single-item clinician rated scale used to assess the subject's improvement or worsening from baseline. Scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse); higher score indicates more affected.|Baseline, Week 6|ITT; N=number of subjects with analyzable data at post-baseline observation.||scores on a scale||Standard Error|Least Squares Mean
716188|NCT00257192|Secondary|Change From Baseline in PANSS: Positive and Negative Subscales at Week 6|PANSS: 30-item clinician-rated scale to measure severity of psychopathology (16 items); positive scale (7 items); negative scale (7 items); summarized as positive score, negative score, and total score. Items scored on anchored Likert scale rated 1 (absent symptoms) to 7 (extreme); scores above 1 indicate clinical symptom is present; scores from 2 to 7 indicate increased severity. Total score range 30 to 210: higher score indicates greater severity.|Baseline, Week 6|ITT; N=number of subjects with analyzable data at post-baseline observation.||scores on a scale||Standard Error|Least Squares Mean
716189|NCT00257192|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Total Score at Week 6|PANSS: 30-item clinician-rated scale to measure severity of psychopathology (16 items); positive scale (7 items); negative scale (7 items); summarized as positive score, negative score, and total score. Items scored on anchored Likert scale rated 1 (absent symptoms) to 7 (extreme); scores above 1 indicate clinical symptom is present; scores from 2 to 7 indicate increased severity. Total score range 30 to 210: higher score indicates greater severity.|Baseline, Week 6|ITT; N=number of subjects with analyzable data at post-baseline observation.||scores on a scale||Standard Error|Least Squares Mean
716190|NCT00257192|Secondary|Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Week 6|CGI-S: single-item clinician rated scale to rate the severity of a subject's illness over time. Scores range from 1 (normal, not at all ill) to 7 (among the most severely ill subjects); higher score indicates more affected.|Baseline, Week 6|ITT; N=number of subjects with analyzable data at post-baseline observation.||scores on a scale||Standard Error|Least Squares Mean
716191|NCT00257192|Primary|Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total Score at Week 6|BPRS-A: 18-item clinician rated scale to assess somatic concern, anxiety, emotional withdrawal, disorganization, hallucinatory behavior, guilt feelings, suspiciousness, disorientation, tension, mannerisms, posturing, grandiosity, depressive mood, hostility, motor retardation, uncooperativeness, unusual thought content, blunted affect, and excitement. Ratings anchored to improve consistency for a single rater over time or between raters. Items rated on 7-point scale 0 (not present) to 6 (extremely severe). Total score=sum of items (range 0 to 108); higher scores indicate increased pathology.|Baseline, Week 6|Intent to treat (ITT): all randomized subjects who had baseline measurements, took at least 1 dose of study medication, and had at least 1 post-baseline visit. N=number of subjects with analyzable data at post-baseline observation.||scores on a scale||Standard Error|Least Squares Mean
716192|NCT00257309|Primary|Death/Reinfarction/Disabling Stroke at 30 Days|Incidence of Death or Reinfarction or Disabling Stroke at 30 days|30 days|||Participants|||Count of Participants
716193|NCT00257309|Primary|Incidence of Death or Reinfarction or Disabling Stroke|Incidence of all-cause death or myocardial reinfarction or disabling stroke|30 days|||participants|||Number
716194|NCT00257322|Primary|Participants Exhibiting Immune Response|Immunological dendritic cell and cellular immune responses to GM-CSF administered in conjunction with chemotherapy for patients with advanced colorectal cancer.|24 Months|||Participants|||Number
716195|NCT00257322|Secondary|Response Rates and Overall Survival.|Effect of cellular immune stimulation on response rates and overall survival. This is a secondary endpoint and while data will be recorded, a larger study with improved power will be necessary to confirm any improvements noted.|24 Months|||Participant|||Number
716196|NCT00257556|Secondary|Mean Estradiol Level|Measurement on day of human chorionic gonadotrophin (hCG) administration / ovulation induction.|Day 7 or 9 or 11 or 13|All patient treated population||picomoles / liter||Standard Deviation|Mean
716197|NCT00257556|Secondary|Mean Endometrial Thickness|Measurement performed on day of human chorionic gonadotrophin (hCG) administration/ovulation induction.|Day 7 or 9 or 11 or 13|All patients treated population||millimeters||Standard Deviation|Mean
716198|NCT00257556|Secondary|Pregnancy Outcomes|Long term follow-up to determine the outcome of the pregnancy.|Approximately 10 months|All patients treated population||participants|||Number
716199|NCT00257556|Secondary|Mean Number of Days Stimulated With Gonadotrophins|Number of days stimulated with study drug until participant met the criteria for ovulation induction. Ovulation induction criteria is three follicles greater than or equal to 17 mm diameter as shown by pelvic ultrasound examination.|study days 1 - 13|All patients treated population||days||Standard Deviation|Mean
716200|NCT00257556|Secondary|Participants With Varying Numbers of Embryos Frozen|Number of participants with different categories of number of embryos frozen.|Approximately study day 17|All patients treated population||participants|||Number
716201|NCT00257556|Secondary|Participants With Varying Numbers of Embryos Transferred|Number of participants with various categories of numbers of embryos transferred.|Approximately study day 17|All patients treated population||participants|||Number
716202|NCT00257556|Secondary|Participants With Varying Numbers of Pronuclear Stage Oocytes|Number of participants with various groupings of pronuclear oocytes retrieved 16-20 hours after insemination.|Approximately study day 15|All patients treated population||participants|||Number
716245|NCT00258154|Secondary|Serum Neutralizing Antibody (SNA) Response to Serotype P1A in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa Predose 1|GMT of serotype P1A in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa Predose 1|Predose (Day 1 of a 3-dose regimen)|Per Protocol Analysis||GMT||95% Confidence Interval|Geometric Mean
716203|NCT00257556|Secondary|Participants With Varying Numbers of Oocytes Retrieved|Number of participants with grouped by the number of oocytes retrieved. Oocytes were retrieved following ovulation induction by subcutaneous administration of human chorionic gonadotrophin (hCG) in the form of choriogonadotropin alfa at a dose of 250 micrograms once participants reached the criteria of at least three follicles with >= 17mm in diameter.|Approximately study day 15|All treated patients population.||participants|||Number
716204|NCT00257556|Secondary|Participants With Varying Numbers of Follicles That Were Greater Than or Equal to 17 Millimeters|The criterion for ovulation induction was three follicles ≥ 17 mm diameter as shown by pelvic ultrasound examination. Patients were assessed by pelvic ultrasound on the morning (prior to menotrophin or follitropin alfa administration) of Day 7 and, if appropriate, every 2 days thereafter (Days 9/11/13) until the criterion was met.|Day 7 and, if appropriate, every 2 days thereafter (Days 9/11/13)|All treated patients population||participants|||Number
716205|NCT00257556|Primary|Percentage of Participants With an Ongoing Pregnancy|Percentage of participants who had an ongoing pregnancy ≥ 9 weeks after the first positive pregnancy test, as indicated by positive fetal heart action.|Approx week 13; 9 weeks or more after the first positive pregnancy test|"All patients treated population. Two menotrophin patients did not have pregnancy outcome data recorded in this timeframe but were later recorded as having live births so are included here as YES for ongoing pregnancy."||percentage of participants|||Number
716206|NCT00257556|Primary|Number of Participants With an Ongoing Pregnancy|Number of participants who met human chorionic gonadotrophin (hCG) criterion, received an embryo transfer, tested positive with a serum pregnancy test 11-14 days after embryo transfer and had an ongoing pregnancy (defined as positive fetal heart action) at ≥ 9 weeks after the first positive pregnancy test.|Approx week 13; 9 weeks or more after the 1st positive pregnancy test|All patients treated population||participants|||Number
716207|NCT00257608|Secondary|Overall Survival|Overall survival was defined as the length of time from randomization to death.|Approximately 3.5 years|Intent-to-treat population included all participants who were randomized during the post-chemotherapy phase.||months||95% Confidence Interval|Median
716208|NCT00257608|Secondary|Incidence of Study Treatment Discontinuation|Participants in post-chemotherapy phase were discontinued from the study for the reasons other than disease progression. Data presented Up to data cutoff 18 July 2008.|Approximately 3 years|Intent to treat (ITT) population included all participants who were randomized during the post-chemotherapy phase.. N= Number of participants analyzed.||participants|||Number
716209|NCT00257608|Secondary|Incidence of Study Treatment Discontinuation for Reasons Other Than Disease Progression in Chemotherapy Phase|Participants who experienced disease progression were discontinued from the study. Data presented up to data cutoff (18 July 2008).|Approximately 3 years|Enrolled participants: All participants who were enrolled in the study. N= Number of participants analyzed.||participants|||Number
716210|NCT00257608|Secondary|Number of Participants With Any Adverse Events During Post-Chemotherapy Phase|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event. Data presented up to data cutoff 19 June 2009.|Approximately 3.5 years|Safety-evaluable randomized Participants: All randomized Participants who received at least one complete or partial dose of Bevacizumab + Erlotinib or Bevacizumab + Placebo. N= Number of participants analyzed. At the time of the 28 January 2009 data cutoff, an additional 25 patients had been randomized.||participants|||Number
716211|NCT00257608|Secondary|Number of Participants With Prospectively Identified Treatment Emergent Adverse Events (TEAE) During Post-Chemotherapy Phase|Treatment-related adverse events are defined as new events that occur following subject entry into the study or events that worsen following study entry state and are judged by the investigator to be possibly, probably or definitely related to study medication. Pulmonary hemorrhage, GI perforation, ATE events, proteinuria, CHF, and hypertension were prospectively identified TEAEs of grade >=3. Data presented until cut-off date 28 January 2009.|Approximately 3 years|Safety-evaluable randomized Participants: All randomized Participants who received at least one complete or partial dose of Bevacizumab + Erlotinib or Bevacizumab + Placebo. N= Number of participants analyzed.||participants|||Number
716212|NCT00257608|Secondary|Number of Participants With Prospectively Identified Treatment Emergent Adverse Events (TEAE) During Chemotherapy Phase|Treatment-emergent adverse events were events between administration of study drug and up to 30 days after last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state.. Number of participants who had Grade >=3TEAEs of pulmonary hemorrhage, gastrointestinal (GI) perforation, arterial thromboembolic (ATE) events, proteinuria, congestive heart failure (CHF), and hypertension were presented. Data presented up to data cutoff 18 July 2008.|Approximately 3 years|Safety-evaluable enrolled participants: All participants who enrolled and received at least one dose of chemotherapy or Bevacizumab. N= Number of participants analyzed.||participants|||Number
716213|NCT00257608|Primary|Progression-free Survival (PFS)|PFS was defined as the length of time from randomization until documented disease progression or death from any cause, whichever occurred earlier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Data presented until cut-off date 18 July 2008.|Approximately 3 years|Intent to treat (ITT) population included all participants who were randomized during the post-chemotherapy phase.||months||95% Confidence Interval|Median
716214|NCT00257660|Secondary|Number of Participants Considered by the Investigator to be Overall Treatment Successes|The number of participants considered to be overall treatment successes by the investigator at week 12 was assessed.|Week 12|Analysis was performed on intention to treat population which consisted of 55 participants on Dysport and 61 on Placebo.||participants|||Number
716246|NCT00258154|Secondary|Serum Neutralizing Antibody (SNA) Response to Serotype G4 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa 42 Days After a 3-dose Regimen|GMT of serotype G4 in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen|42 days after a 3-dose regimen|Per Protocol Analysis||GMT||95% Confidence Interval|Geometric Mean
716215|NCT00257660|Secondary|SF-36 Physical Health Summary Score|SF-36 is a Quality of Life scale comprising eight individual domains. The QoL score for each domain is on a scale from 0 (worst health possible) to 100 (best health possible). SF-36 Physical Health Summary Score is derived from four individual domains (physical functioning, role physical, bodily pain and general health).|Week 8|Analysis was performed on intention to treat population which consisted of 55 subjects on Dysport and 61 on Placebo. There were 13 subjects on Dysport and 24 on placebo who were not assessed on the change in physical health summary at Week 8. There was no imputation of missing scores, so these 37 subjects were not taken into account.||points on a scale||Standard Deviation|Mean
716216|NCT00257660|Secondary|SF-36 Mental Health Summary Score|SF-36 is a Quality of Life scale comprising eight individual domains. The QoL score for each domain is on a scale from 0 (worst health possible) to 100 (best health possible). SF-36 Mental Health Summary Score is derived from four individual domains (vitality, social functioning, role limitations due to emotional problems and mental health).|Week 8|Analysis was performed on intention to treat population which consisted of 55 subjects on Dysport and 61 on Placebo. There were 13 subjects on Dysport and 24 on placebo who were not assessed on the change in mental health summary at Week 8. There was no imputation of missing scores, so these 37 subjects were not taken into account.||points on a scale||Standard Deviation|Mean
716217|NCT00257660|Secondary|Investigator's VAS for CD Symptom Assessment|The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms) to 100 mm (worst possible symptoms).|Baseline and week 12|Analysis was performed on intention to treat population which consisted of 55 subjects on Dysport and 61 on Placebo. Missing assessments at Week 12 were imputed using Last Observation Carried Forward (LOCF) methodology. There was no imputation for 3 patients with missing baseline, Week 4 and Week 8 values.||points on a scale||Standard Deviation|Mean
716218|NCT00257660|Secondary|Subject VAS for CD Symptom Assessment|The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms).|Baseline and week 12|Analysis was performed on intention to treat population which consisted of 55 subjects on Dysport and 61 on Placebo. Missing assessments at Week 12 were imputed using Last Observation Carried Forward (LOCF) methodology. There was no imputation for 4 patients on placebo with missing baseline, Week 4 and Week 8 values.||points on a scale||Standard Deviation|Mean
716219|NCT00257660|Secondary|Investigator's VAS for CD Symptom Assessment|The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms).|Baseline and week 8|Analysis was performed on intention to treat population which consisted of 55 subjects on Dysport and 61 on Placebo. Missing assessments at Week 8 were imputed using Last Observation Carried Forward (LOCF) methodology. There was no imputation for 3 patients with missing baseline and Week 4 values.||points on a scale||Standard Deviation|Mean
716220|NCT00257660|Secondary|Subject VAS for CD Symptom Assessment|The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100mm (worst possible symptoms).|Baseline and Week 8|Analysis was performed on intention to treat population which consisted of 55 subjects on Dysport and 61 on Placebo. Missing assessments at Week 8 were imputed using Last Observation Carried Forward (LOCF) methodology. There was no imputation for 4 patients on placebo with missing baseline and Week 4 values.||points on a scale||Standard Deviation|Mean
716221|NCT00257660|Secondary|Investigator VAS for CD Symptom Assessment|The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms).|Baseline and Week 4|Analysis was performed on intention to treat population which consisted of 55 subjects receiving Dysport and 61 Placebo. There were 3 subjects for Dysport and 5 for placebo who were not assessed on the change in investigator VAS score at Week 4. As there was no imputation of missing VAS scores, these 8 subjects were not taken into account.||points on a scale||Standard Deviation|Mean
716222|NCT00257660|Secondary|Subject Visual Analogue Score (VAS) for Cervical Dystonia (CD) Symptom Assessment|The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms).|Baseline and Week 4|Analysis was performed on intention to treat population which consisted of 55 subjects on Dysport and 61 on Placebo. There were 5 subjects on Dysport and 8 on placebo who were not assessed on the change in subject VAS score for CD symptoms at Week 4. There was no imputation of missing VAS scores, so these 13 subjects were not taken into account.||points on a scale||Standard Deviation|Mean
716223|NCT00257660|Secondary|Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score|TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for each is the following: for severity from 0 (absence of severity) to 35 (max severity), for disability from 0 (no disability) to 30 (max disability) and for pain from 0 (no pain) to 20 (max pain). TWSTRS total score is the sum of the 3 component scores, with a range from 0 to a maximum of 85. The change in TWSTRS total score is the score at week 4 minus the score at baseline.|Baseline and Week 12|The analysis was performed on the intention to treat population which consisted of 55 subjects receiving Dysport and 61 Placebo. There were 10 subjects for Dysport and 17 for placebo who were not assessed on TWSTRS score at Week 12. As there was no imputation of missing TWSTRS score values, these 27 subjects were not taken into account.||points on a scale||Standard Deviation|Mean
716224|NCT00257660|Secondary|Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)|TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for each is the following: for severity from 0 (absence of severity) to 35 (max severity), for disability from 0 (no disability) to 30 (max disability) and for pain from 0 (no pain) to 20 (max pain). TWSTRS total score is the sum of the 3 component scores, with a range from 0 to a maximum of 85. The change in TWSTRS total score is the score at week 4 minus the score at baseline.|Baseline and Week 8|The analysis was performed on the intention to treat population which consisted of 55 subjects receiving Dysport and 61 Placebo. There were 9 subjects for Dysport and 15 for placebo who were not assessed on TWSTRS score at Week 8. As there was no imputation of missing TWSTRS score values, these 24 subjects were not taken into account.||points on a scale||Standard Deviation|Mean
716247|NCT00258154|Secondary|Serum Neutralizing Antibody (SNA) Response to Serotype G4 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa Predose 1|GMT of serotype G4 in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa Predose 1|Predose (Day 1 of a 3-dose regimen)|Per Protocol Analysis||GMT||95% Confidence Interval|Geometric Mean
716225|NCT00257660|Primary|Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)|TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for each is the following: for severity from 0 (absence of severity) to 35 (max severity), for disability from 0 (no disability) to 30 (max disability) and for pain from 0 (no pain) to 20 (max pain). TWSTRS total score is the sum of the 3 component scores, with a range from 0 to a maximum of 85. The change in TWSTRS total score is the score at week 4 minus the score at baseline.|Baseline and Week 4|The analysis was performed on the intention to treat population which consisted of 55 subjects receiving Dysport and 61 Placebo. There were 4 subjects for Dysport and 3 for placebo who were not assessed on TWSTRS score at Week 4. As there was no imputation of missing TWSTRS score values, these 7 subjects were not taken into account.||points on a scale||Standard Deviation|Mean
716226|NCT00257686|Secondary|Percent Change From Baseline in TC|Percent change from baseline in total cholesterol (TC)|Baseline to 12 weeks|||Percent change||Standard Deviation|Mean
716227|NCT00257686|Primary|Percent Change From Baseline in LDL-C|Percent change from baseline in low density cholesterol (LDL-C)|Baseline to 12 weeks|||Percent change||Standard Deviation|Mean
716228|NCT00257894|Primary|Minnesota Nicotine Withdrawal Questionnaire|"Measure of degree of nicotine withdrawal at the time. Scored as the mean of 8 5-point ratings so the total score ranges from 0 (no withdrawal) to 4 (severe withdrawal).
These data are only available on the subset of participants who participated through Day 10."|Day 10|||units on a scale||Standard Deviation|Mean
716229|NCT00257894|Secondary|Cigarette Choice Task|"At 20 times spaced over a 2.5 h period, participants chose between smoking two puffs (of pre-determined size) of a cigarette and receiving US$0.10. The primary behavioral outcome measure was number of cigarette choices, ranging from 0 (no smoking) to 20 (smoking the most allowed).
These data are only available on the subset of participants who participated through Day 10."|Tenth day of medication titration|||choices||Standard Deviation|Mean
716230|NCT00257894|Secondary|Nicotine Self-administration as Quantified by Carbon Monoxide Boost During a Behavioral Self-administration Task.|"Expired carbon monoxide (CO) assessed before and after a 2.5-h period when they make choices for cigarette puffs versus money. CO Boost is the difference score, possibly ranging from -25 (improved) to +25 (worse).
These data are only available on the subset of participants who participated through Day 10.."|Measures are assessed on the tenth day of medication titration, after 5 hours of smoking deprivation.|||units on a scale||Standard Deviation|Mean
716231|NCT00257894|Primary|Total Score on Questionnaire of Smoking Urges|"Questionnaire of Smoking Urges assesses cravings to smoke. the score is the mean of 10 7-point Likert ratings so the range of the total score is from 1 (no urge) to 7 (intense urge).
These data are only available on the subset of participants who participated through Day 10."|Measures are assessed on the tenth day of medication titration, after 5 hours of smoking deprivation.|||units on a scale||Standard Deviation|Mean
716232|NCT00257920|Primary|Calcium Absorption Fractions Analyzed by Analysis of Variance (ANOVA)|Calcium Absorption Fraction obtained at the end of Period 1 & Period 2|42 Days|Per-Protocol Population - all subjects who completed both Period 1 and 2 and did not have major protocol violations.||Fractions||Standard Error|Least Squares Mean
716233|NCT00257920|Secondary|Calcium Absorption Fractions Analyzed by Mixed Model|Calcium Absorption Fraction obtained at the end of Period 1 & Period 2|42 Days|ITT Population -all randomized subjects who received at least one dose of study drug and were analyzed by the randomized treatment sequence assigned to each subject.||Fractions||Standard Error|Least Squares Mean
716234|NCT00257933|Secondary|Rate of Relapse Between Treatment Groups||2 weeks after hospitalization||||||
716235|NCT00257933|Secondary|Differences in Clinical Asthma Symptom Scores During Hospitalization Between Treatment Groups||Every 4 hours during hospitalization||||||
716236|NCT00257933|Secondary|The Rate and Degree of Change in Forced Expiratory Volume (FEV1) and Peak Expiratory Flow (PEF) Between Treatment Groups||Every 4 hours during hospitalization||||||
716237|NCT00257933|Secondary|Time Spent in Each Severity Level of the Asthma Care Pathway||Time spent in each severity level of pathway||||||
716238|NCT00257933|Secondary|Time Measured From the Writing of the Admission Order Until the Writing of the Discharge Order||Mean time from writing admit order until discharge order||||||
716239|NCT00257933|Primary|Time Measured From the Administration of the Loading Dose of Prednisolone (2mg/kg up to Max 60mg) in the Emergency Department (ED) Until the Home Dose of Albuterol is Administered||Median time from loading dose to home dose of albuterol|||Hours||Inter-Quartile Range|Median
716240|NCT00258011|Secondary|Urinary Glycosaminoglycan (GAG) Excretion|Percentage change in the concentration of GAG relative to creatinine in urine (ug GAG/mg creatinine) from baseline to last study visit. Greater decrease indicates greater response.|Up to 73 Weeks|"The study enrolled eligible MPS I patients prior to marketing authorization in Japan. The analysis was intention to treat. >
* 1 patient final visit = Week 73; 1 patient final visit = Week 32; 1 patient final visit = Week 10"||percent change in concentration of GAG||Standard Deviation|Mean
716241|NCT00258011|Primary|Safety Evaluation|Overall Safety Summary of Adverse Events (AEs) during Treatment Safety assessment was based on the incidence of AE reports.|Up to 73 Weeks|The study enrolled eligible MPS I patients prior to marketing authorization in Japan. The analysis was intention to treat.||participants|||Number
716242|NCT00258154|Secondary|Serum Neutralizing Antibody (SNA) Response to Serum Anti-rotavirus IgA in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa 42 Days After a 3-dose Regimen|GMT of serum anti-rotavirus IgA in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen|42 days after a 3-dose regimen|Per Protocol Analysis||GMT||95% Confidence Interval|Geometric Mean
716243|NCT00258154|Secondary|Serum Neutralizing Antibody (SNA) Response to Serum Anti-rotavirus IgA in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa Predose 1|GMT of serum anti-rotavirus IgA in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa Predose 1|Predose (Day 1 of a 3-dose regimen)|Per Protocol Analysis||GMT||95% Confidence Interval|Geometric Mean
716244|NCT00258154|Secondary|Serum Neutralizing Antibody (SNA) Response to Serotype P1A in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa 42 Days After a 3-dose Regimen|GMT of serotype P1A in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen|42 days after a 3-dose regimen|Per Protocol Analysis||GMT||95% Confidence Interval|Geometric Mean
716248|NCT00258154|Secondary|Serum Neutralizing Antibody (SNA) Response to Serotype G3 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa 42 Days After a 3-dose Regimen|GMT of serotype G3 in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen|42 days after a 3-dose regimen|Per Protocol Analysis||GMT||95% Confidence Interval|Geometric Mean
716249|NCT00258154|Secondary|Serum Neutralizing Antibody (SNA) Response to Serotype G3 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa Predose 1|GMT of serotype G3 in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa Predose 1|Predose (Day 1 of a 3-dose regimen)|Per Protocol Analysis||GMT||95% Confidence Interval|Geometric Mean
716250|NCT00258154|Secondary|Serum Neutralizing Antibody (SNA) Response to Serotype G2 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa 42 Days After a 3-dose Regimen|GMT of serotype G2 in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen|42 days after a 3-dose regimen|Per Protocol Analysis||GMT||95% Confidence Interval|Geometric Mean
716251|NCT00258154|Secondary|Serum Neutralizing Antibody (SNA) Response to Serotype G2 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa, Predose 1|GMT of serotype G2 in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa at the start of a 3-dose regimen|Predose (Day 1 of a 3-dose regimen)|Per Protocol Analysis||GMT||95% Confidence Interval|Geometric Mean
716252|NCT00258154|Secondary|Serum Neutralizing Antibody (SNA) Response to Serotype G1 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa, 42 Days After a 3-dose Regimen|GMT of serotype G1 in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen|42 days after a 3-dose regimen|Per Protocol Analysis||GMT||95% Confidence Interval|Geometric Mean
716253|NCT00258154|Secondary|Serum Neutralizing Antibody (SNA) Response to Serotype G1 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa, Predose 1|GMT of serotype G1 in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa at the start of a 3-dose regimen|Predose (Day 1 of a 3-dose regimen)|Per Protocol Analysis||GMT||95% Confidence Interval|Geometric Mean
716254|NCT00258154|Secondary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Pertussis Toxoid When Administered Concomitantly With RotaTeq™, 42 Days After a 3-dose Regimen|GMT of pertussis toxoid in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen|42 days after a 3-dose regimen|Per Protocol Analysis||EU/mL||95% Confidence Interval|Geometric Mean
716255|NCT00258154|Secondary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Pertussis Toxoid When Administered Concomitantly With RotaTeq™, Predose 1|GMT of pertussis toxoid in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa at the start of a 3-dose regimen|Predose (Day 1 of a 3-dose regimen)|Per Protocol Analysis||EU/mL||95% Confidence Interval|Geometric Mean
716256|NCT00258154|Secondary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Pertussis Pertactin When Administered Concomitantly With RotaTeq™, 42 Days After a 3-dose Regimen|GMT of pertussis Pertactin in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen|42 days after a 3-dose regimen|Per Protocol Analysis||EU/mL||95% Confidence Interval|Geometric Mean
716257|NCT00258154|Secondary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Pertussis Pertactin When Administered Concomitantly With RotaTeq™, Predose 1|GMT of pertussis Pertactin in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa at the start of a 3-dose regimen|Predose (Day 1 of a 3-dose regimen)|Per Protocol Analysis||EU/mL||95% Confidence Interval|Geometric Mean
716258|NCT00258154|Secondary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Pertussis FHA When Administered Concomitantly With RotaTeq™, 42 Days After a 3-dose Regimen|GMT of pertussis FHA in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen|42 days after a 3-dose regimen|Per Protocol Analysis||EU/mL||95% Confidence Interval|Least Squares Mean
716259|NCT00258154|Secondary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Pertussis FHA When Administered Concomitantly With RotaTeq™, Predose 1|GMT of pertussis FHA in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa at the start of a 3-dose regimen|Predose (Day 1 of a 3-dose regimen)|Per Protocol Analysis||EU/mL||95% Confidence Interval|Geometric Mean
716260|NCT00258154|Secondary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Tetanus Toxoid When Administered Concomitantly With RotaTeq™, 42 Days After a 3-dose Regimen|GMT of tetanus toxoid in subjects with odd allocation numbers, receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen|42 days after a 3-dose regimen|Per Protocol Analysis on Subset B (subjects with odd allocation numbers||Dilution Unit||95% Confidence Interval|Geometric Mean
716261|NCT00258154|Secondary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Tetanus Toxoid When Administered Concomitantly With RotaTeq™, Predose 1|GMT of tetanus toxoid in subjects with odd allocation numbers, receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa at the start of a 3-dose regimen|Predose (Day 1 of a 3-dose regimen)|Per Protocol Analysis on Subset B (subjects with odd allocation numbers)||IU/mL||95% Confidence Interval|Geometric Mean
716262|NCT00258154|Secondary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Diphtheria Toxoid When Administered Concomitantly With RotaTeq™, 42 Days After a 3-dose Regimen|GMT of diphtheria toxoid in subjects with odd allocation numbers, receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen|42 days after a 3-dose regimen|Per Protocol Analysis on Subset B (subjects with odd allocation number)||IU/mL||95% Confidence Interval|Geometric Mean
716263|NCT00258154|Secondary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Diphtheria Toxoid When Administered Concomitantly With RotaTeq™, Predose 1|GMT of diphtheria toxoid in subjects with odd allocation numbers, receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa at the start of a 3-dose regimen|Predose (Day 1 of a 3-dose regimen)|Per Protocol Analysis on Subset B (subjects with odd allocation number)||IU/mL||95% Confidence Interval|Geometric Mean
716264|NCT00258154|Secondary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 3 When Administered Concomitantly With RotaTeq™, 42 Days After a 3-dose Regimen|GMT of Poliovirus Type 3 in subjects with even allocation numbers, receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen|42 days after a 3-dose regimen|Per Protocol Analysis on Subset A (subjects with even allocation numbers)||Dilution Unit||95% Confidence Interval|Geometric Mean
716265|NCT00258154|Secondary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 3 When Administered Concomitantly With RotaTeq™, Predose 1|GMT of Poliovirus Type 3 in subjects with even allocation numbers, receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa at the start of a 3-dose regimen|Predose (Day 1 of a 3-dose regimen)|Per Protocol Analysis on Subset A (subjects with even allocation numbers)||Dilution Unit||95% Confidence Interval|Geometric Mean
716266|NCT00258154|Secondary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 2 When Administered Concomitantly With RotaTeq™, 42 Days After a 3-dose Regimen|GMT of Poliovirus Type 2 in subjects with even allocation numbers, receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen|42 days after in a 3-dose regimen|Per Protocol Analysis on Subset A (subjects with even allocation numbers)||Dilution Unit||95% Confidence Interval|Geometric Mean
716267|NCT00258154|Secondary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 2 When Administered Concomitantly With RotaTeq™, Predose 1|GMT of Poliovirus Type 2 in subjects with even allocation numbers, receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa at the start of a 3-dose regimen|Pre-dose (Day 1 of a 3-dose regimen)|Per Protocol Analysis on Subset A (subjects with even allocation numbers)||Dilution Unit||95% Confidence Interval|Geometric Mean
716268|NCT00258154|Secondary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 1 When Administered Concomitantly With RotaTeq™, 42 Days After a 3-dose Regimen|GMT of Poliovirus Type 1 in subjects with even allocation numbers, receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa , 42 days after a 3-dose regimen|42 days after a 3-dose regimen|Per Protocol Analysis on Subset A (subjects with even allocation numbers)||Dilution Unit||95% Confidence Interval|Geometric Mean
716269|NCT00258154|Primary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Anti-polyribosylribitol Phosphate PRP at 42 Days After a 3-dose Regimen|GMT/antibody responses to RotaTeq™ and INFANRIX™ hexa in relation to serum anti-polyribosylribitol phosphate PRP at 42 days after a 3-dose regimen|42 days after a 3-dose regimen|All per-protocol subjects were included in the analysis of primary endpoints for polyribosylribitol phosphate (PRP) and hepatitis B surface antigen (HBsAg). Subjects listed in the Protocol Violation Memo were excluded from the immunogenicity analysis; N analyzed = number of subjects contributing to per protocol analysis.||ng/mL||95% Confidence Interval|Geometric Mean
716270|NCT00258154|Primary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Anti-polyribosylribitol Phosphate PRP, Predose 1|GMT/antibody responses to RotaTeq™ and INFANRIX™ hexa in relation to serum anti-polyribosylribitol phosphate PRP at start of 3-dose regimen|Day 1 of 3-dose regimen|All per-protocol subjects were included in the analysis of primary endpoints for polyribosylribitol phosphate (PRP) and hepatitis B surface antigen (HBsAg). Subjects listed in the Protocol Violation Memo were excluded from the immunogenicity analysis; N analyzed = number of subjects contributing to per protocol analysis.||ng/mL||95% Confidence Interval|Geometric Mean
716271|NCT00258154|Primary|Immunogenicity of INFANRIX™ Hexa in Relation to Anti-hepatitis B Surface Antigen HBsAg , at 42 Days After a 3-dose Regimen|GMT/antibody responses to RotaTeq™ and INFANRIX™ in relation to anti-hepatitis B surface antigen HBsAg at 42 days after 3-dose regimen|42 days after 3-dose regimen|All per-protocol subjects were included in the analysis of primary endpoints for polyribosylribitol phosphate (PRP) and hepatitis B surface antigen (HBsAg). Subjects listed in the Protocol Violation Memo were excluded from the immunogenicity analysis; N analyzed = number of subjects contributing to per protocol analysis.||mIU/mL||95% Confidence Interval|Geometric Mean
716272|NCT00258154|Secondary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 1 When Administered Concomitantly With RotaTeq™, Predose 1|GMT of Poliovirus Type 1 in subjects with even allocation numbers, receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa at the start of a 3-dose regimen|Predose (Day 1 of a 3-dose regimen)|Per Protocol Analysis on Subset A (subjects with even allocation numbers)||Dilution Unit||95% Confidence Interval|Geometric Mean
716273|NCT00258154|Primary|Immunogenicity of INFANRIX™ Hexa in Relation to Anti-hepatitis B Surface Antigen HBsAg, Predose 1|Geometric Mean Titer (GMT)/antibody responses to RotaTeq™ and INFANRIX™ in relation to anti-hepatitis B surface antigen HBsAg at start of a 3-dose regimen|Day 1 of a 3-dose regimen|All per-protocol subjects were included in the analysis of primary endpoints for polyribosylribitol phosphate (PRP) and hepatitis B surface antigen (HBsAg). Subjects listed in the Protocol Violation Memo were excluded from the immunogenicity analysis; N analyzed = number of subjects contributing to per protocol analysis.||mIU/mL||95% Confidence Interval|Geometric Mean
716274|NCT00258206|Secondary|Overall Survival||5 years||||||
716275|NCT00258206|Secondary|Effect of Rituximab by Clonogenic Growth of Multiple Myeloma (MM) Progenitors and the Mechanisms by Which MM Stem Cells Are Inhibited||2, 3, 6, 9, and 12 months||||||
716276|NCT00258206|Secondary|Complete Response (CR) Rate and Partial Response (PR) Rate||1 year||||||
716277|NCT00258206|Secondary|Safety and Toxicity||2, 3, 6, 9, and 12 months||||||
716278|NCT00258206|Primary|Safety of Maintenance Rituximab Following High Dose Cyclophosphamide||2, 3, 6, 9, and 12 months||||||
716279|NCT00258206|Primary|Event-free Survival|Percentage of study participants who did not report that their multiple myeloma relapsed or progressed (got worse)|1 year|||percentage of participants|||Number
716280|NCT00258310|Secondary|Incidence of Second Primary Tumor Occurrence||Every 12 months||||||
716281|NCT00258310|Secondary|Survival Rate||from time of study entry until death||||||
716282|NCT00258310|Secondary|Local-regional Control Rate Occurrence||within 365 days||||||
716283|NCT00258310|Secondary|Time to Recurrence||assessed from time of study entry until documented||||||
716284|NCT00258310|Primary|Feasibility of Treatment as Assessed.|Compliance was taking at least 80% of the prescribed dose for one year.|within 365 days|||percentage of participants||95% Confidence Interval|Number
716286|NCT00258349|Secondary|Time to Progression|Tumor response is assessed by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0. Disease progression is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s). Time to progression is defined as time from registration to disease progression.|Tumor assessment was obtained at baseline, after 6 weeks (week 6 = last week of Cycle 2), and after every 4 cycles of therapy|10 eligible HER2-positive (by central review) patients||months||95% Confidence Interval|Median
716287|NCT00258349|Primary|Response Rate|Tumor response is assessed by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0. Response included complete response (CR) and partial response (PR). CR is defined as the disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter.|Tumor assessment was obtained at baseline, after 6 weeks (week 6 = last week of Cycle 2), and after every 4 cycles of therapy|10 eligible HER2-positive (by central review) patients||percentage of participants||95% Confidence Interval|Number
716288|NCT00258362|Secondary|Percent of Patients Estimated to be Alive|This estimate of overall survival was determined by using the statistical method (Kaplan-Meier) of analysis.|1 Year, 2 Years, 3 Years|All 41 patients were included in this analysis.||Percentage of Patients|||Number
716289|NCT00258362|Primary|Percent of Patients Estimated to be Progression-Free and Alive|This estimate was determined by using a statistical method of analysis (Kaplan-Meier).|1 Year, 2 Years, 3 Years|Two patients with recurrent disease at study entry were excluded from this analysis.||Percentage of Patients|||Number
716290|NCT00266409|Primary|Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Per Protocol Population (Kaplan-Meier-estimates)|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Total possible score is 56. Kaplan-Meier-analysis was performed and Kaplan-Meier estimates (cumulative percent of subjects responding) are presented.|10 weeks|Per Protocol Population (subjects of ITT population who have no major protocol violations)||cumulative percent of responders|||Number
716291|NCT00266409|Secondary|Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) at Endpoint During the 8 Week Treatment Period|Endpoint is last observed value during the 8 week treatment period.|at endpoint during the 8 week treatment period|ITT population, Last Observation Carried Forward imputation was applied||participants|||Number
716292|NCT00266409|Secondary|Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 8 Weeks||8 weeks|ITT population, but only subjects with non-missing values have been included||participants|||Number
716293|NCT00266409|Secondary|Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 7 Weeks||7 weeks|ITT population, but only subjects with non-missing values have been included||participants|||Number
716294|NCT00266409|Secondary|Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 6 Weeks||6 weeks|ITT population, but only subjects with non-missing values have been included||participants|||Number
716295|NCT00266409|Secondary|Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 5 Weeks||5 weeks|ITT population, but only subjects with non-missing values have been included||participants|||Number
716296|NCT00266409|Secondary|Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 4 Weeks||4 weeks|ITT population, but only subjects with non-missing values have been included||participants|||Number
716297|NCT00266409|Secondary|Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 3 Weeks||3 weeks|ITT population, but only subjects with non-missing values have been included||participants|||Number
716298|NCT00266409|Secondary|Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 2 Weeks||2 weeks|ITT population, but only subjects with non-missing values have been included||participants|||Number
716299|NCT00266409|Secondary|Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 1 Week||1 week|ITT population, but only patients with non-missing assessments were included||participants|||Number
716300|NCT00266409|Secondary|Change From Baseline in HAM-A-somatic Subscore at Endpoint During the 8 Week Treatment Period|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4. Endpoint is last observed value during the 8 week treatment period.|Baseline and at endpoint during the 8 week treatment period|ITT population, Last Observation Carried Forward imputation was applied||Units on a scale||Standard Deviation|Mean
716301|NCT00266409|Secondary|Change From Baseline in HAM-A-somatic Subscore After 8 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4.|Baseline and 8 weeks|ITT population, but only subjects with non-missing values have been included||Units on a scale||Standard Deviation|Mean
716302|NCT00266409|Secondary|Change From Baseline in HAM-A-somatic Subscore After 7 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4.|Baseline and 7 weeks|ITT population, but only subjects with non-missing values have been included||Units on a scale||Standard Deviation|Mean
716303|NCT00266409|Secondary|Change From Baseline in HAM-A-somatic Subscore After 6 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4.|Baseline and 6 weeks|ITT population, but only subjects with non-missing values have been included||Units on a scale||Standard Deviation|Mean
716304|NCT00266409|Secondary|Change From Baseline in HAM-A-somatic Subscore After 5 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4.|Baseline and 5 weeks|ITT population, but only subjects with non-missing values have been included||Units on a scale||Standard Deviation|Mean
716305|NCT00266409|Secondary|Change From Baseline in HAM-A-somatic Subscore After 4 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4.|Baseline and 4 weeks|ITT population, but only subjects with non-missing values have been included||Units on a scale||Standard Deviation|Mean
716306|NCT00266409|Secondary|Change From Baseline in HAM-A-somatic Subscore After 3 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4.|Baseline and 3 weeks|ITT population, but only subjects with non-missing values have been included||Units on a scale||Standard Deviation|Mean
716307|NCT00266409|Secondary|Change From Baseline in HAM-A-somatic Subscore After 2 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4.|Baseline and 2 weeks|ITT population, but only subjects with non-missing values have been included||Units on a scale||Standard Deviation|Mean
716308|NCT00266409|Secondary|Change From Baseline in HAM-A-somatic Subscore After 1 Week|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4.|Baseline and 1 week|ITT population, but only subjects with non-missing values have been included||Units on a scale||Standard Deviation|Mean
716309|NCT00266409|Secondary|Change From Baseline in HAM-A-psychic Factors Subscore at Endpoint During the 8 Week Treatment Period|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4. Endpoint is last observed value during the 8 week treatment period.|Baseline and at endpoint during the 8 week treatment period|ITT population, Last Observation Carried Forward imputation was applied||Units on a scale||Standard Deviation|Mean
716310|NCT00266409|Secondary|Change From Baseline in HAM-A-psychic Factors Subscore After 8 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4.|Baseline and 8 weeks|ITT population, but only subjects with non-missing values have been included||Units on a scale||Standard Deviation|Mean
716311|NCT00266409|Secondary|Change From Baseline in HAM-A-psychic Factors Subscore After 7 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4.|Baseline and 7 weeks|ITT population, but only subjects with non-missing values have been included||Units on a scale||Standard Deviation|Mean
716312|NCT00266409|Secondary|Change From Baseline in HAM-A-psychic Factors Subscore After 6 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4.|Baseline and 6 weeks|ITT population, but only subjects with non-missing values have been included||Units on a scale||Standard Deviation|Mean
716313|NCT00266409|Secondary|Change From Baseline in HAM-A-psychic Factors Subscore After 5 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4.|Baseline and 5 weeks|ITT population, but only subjects with non-missing values have been included||Units on a scale||Standard Deviation|Mean
716314|NCT00266409|Secondary|Change From Baseline in HAM-A-psychic Factors Subscore After 4 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4.|Baseline and 4 weeks|ITT population, but only subjects with non-missing values have been included||Units on a scale||Standard Deviation|Mean
716315|NCT00266409|Secondary|Change From Baseline in HAM-A-psychic Factors Subscore After 3 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4.|Baseline and 3 weeks|ITT population, but only subjects with non-missing values have been included||Units on a scale||Standard Deviation|Mean
716316|NCT00266409|Secondary|Change From Baseline in HAM-A-psychic Factors Subscore After 2 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4.|Baseline and 2 weeks|ITT population, but only subjects with non-missing values have been included||Units on a scale||Standard Deviation|Mean
716317|NCT00266409|Secondary|Change From Baseline in HAM-A-psychic Factors Subscore After 1 Week|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4.|Baseline and 1 week|ITT population, but only subjects with non-missing values have been included||Units on a scale||Standard Deviation|Mean
716318|NCT00266409|Secondary|Change From Baseline in HAM-A-insomnia Subscore at Endpoint During the 8 Week Treatment Period|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4. Endpoint is last observed value during the 8 week treatment period.|Baseline and at endpoint during the 8 week treatment period|ITT population, Last Observation Carried Forward imputation was applied||Units on a scale||Standard Deviation|Mean
716319|NCT00266409|Secondary|Change From Baseline in HAM-A-insomnia Subscore After 8 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4.|Baseline and 8 weeks|ITT population, but only subjects with non-missing values have been included||Units on a scale||Standard Deviation|Mean
716320|NCT00266409|Secondary|Change From Baseline in HAM-A-insomnia Subscore After 7 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4.|Baseline and 7 weeks|ITT population, but only subjects with non-missing values have been included||Units on a scale||Standard Deviation|Mean
716321|NCT00266409|Secondary|Change From Baseline in HAM-A-insomnia Subscore After 6 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4.|Baseline and 6 weeks|ITT population, but only subjects with non-missing values have been included||Units on a scale||Standard Deviation|Mean
716322|NCT00266409|Secondary|Change From Baseline in HAM-A-insomnia Subscore After 5 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4.|Baseline and 5 weeks|ITT population, but only subjects with non-missing values have been included||Units on a scale||Standard Deviation|Mean
716323|NCT00266409|Secondary|Change From Baseline in HAM-A-insomnia Subscore After 4 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4.|Baseline and 4 weeks|ITT population, but only subjects with non-missing values have been included||Units on a scale||Standard Deviation|Mean
716324|NCT00266409|Secondary|Change From Baseline in HAM-A-insomnia Subscore After 3 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4.|Baseline and 3 weeks|ITT population, but only subjects with non-missing values have been included||Units on a scale||Standard Deviation|Mean
716325|NCT00266409|Secondary|Change From Baseline in HAM-A-insomnia Subscore After 2 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4.|Baseline and 2 weeks|ITT population, but only subjects with non-missing values have been included||Units on a scale||Standard Deviation|Mean
716326|NCT00266409|Secondary|Change From Baseline in HAM-A-insomnia Subscore After 1 Week|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4.|Baseline and 1 week|ITT population, but only subjects with non-missing values have been included||Units on a scale||Standard Deviation|Mean
716327|NCT00266409|Secondary|Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score at Endpoint During the 8 Week Treatment Period|The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables). Endpoint is last observed value during the 8 week treatment period.|at endpoint during the 8 week treatment period|ITT population, Last Observation Carried Forward imputation was applied||participants|||Number
716328|NCT00266409|Secondary|Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 8 Weeks|The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables).|8 weeks|ITT population, Last Observation Carried Forward imputation was applied||participants|||Number
716329|NCT00266409|Secondary|Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 7 Weeks|The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables).|7 weeks|ITT population, but only subjects with non-missing values have been included||participants|||Number
716330|NCT00266409|Secondary|Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 6 Weeks|The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables).|6 weeks|ITT population, but only subjects with non-missing values have been included||participants|||Number
716331|NCT00266409|Secondary|Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 5 Weeks|The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables).|5 weeks|ITT population, but only subjects with non-missing values have been included||participants|||Number
716332|NCT00266409|Secondary|Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 4 Weeks|The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables).|4 weeks|ITT population, but only subjects with non-missing values have been included||participants|||Number
716333|NCT00266409|Secondary|Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 3 Weeks|The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables).|3 weeks|ITT population, but only subjects with non-missing values have been included||participants|||Number
716334|NCT00266409|Secondary|Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 2 Weeks|The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect.|2 weeks|ITT population, but only subjects with non-missing values have been included||participants|||Number
716335|NCT00266409|Secondary|Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 1 Week|The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables).|1 week|ITT population, but only patients with non-missing values are included in the analysis||participants|||Number
716336|NCT00266409|Secondary|Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score at Endpoint During the 8 Week Treatment Period|The Clinical Global Impression Improvement (CGI-I) scale is a 7 point ordinal scale that assesses how the patient's illness has improved ranging from 'very much improved' to 'very much worse'(see definition of categories in results table). Endpoint is last observed value during the 8 week treatment period.|Baseline and at endpoint during the 8 week treatment period|ITT population, but only subjects with non-missing values have been included||participants|||Number
716337|NCT00266409|Secondary|Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 8 Weeks|The Clinical Global Impression Improvement (CGI-I) scale is a 7 point ordinal scale that assesses how the patient's illness has improved ranging from 'very much improved' to 'very much worse'(see definition of categories in results table).|Baseline and 8 weeks|ITT population, but only subjects with non-missing values have been included||participants|||Number
716338|NCT00266409|Secondary|Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 4 Weeks|The Clinical Global Impression Improvement (CGI-I) scale is a 7 point ordinal scale that assesses how the patient's illness has improved ranging from 'very much improved' to 'very much worse'(see definition of categories in results table).|Baseline and 4 weeks|ITT population, but only subjects with non-missing values have been included||participants|||Number
716339|NCT00266409|Secondary|Change in Severity of Illness From Baseline Using the Clinical Global Impression Improvement (CGI-I) Score After 2 Weeks|The Clinical Global Impression Improvement (CGI-I) scale is a 7 point ordinal scale that assesses how the patient's illness has improved ranging from 'very much improved' to 'very much worse'(see definition of categories in results table).|Baseline and 2 weeks|ITT population, but only patients with non-missing values were included||Participants|||Number
716340|NCT00266409|Secondary|Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) at Endpoint During the 8 Week Treatment Period|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Endpoint is last observed value during the 8 week treatment period.|at endpoint during the 8 week treatment period|ITT population, Last Observation Carried Forward imputation was applied||participants|||Number
716341|NCT00266409|Secondary|Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 8 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe).|8 weeks|ITT population, but only patients with a non-missing value at timepoint are included in the analysis||participants|||Number
716342|NCT00266409|Secondary|Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 7 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe).|7 weeks|ITT population, but only patients with a non-missing value at timepoint are included in the analysis||participants|||Number
716343|NCT00266409|Secondary|Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 6 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe).|6 weeks|ITT population, but only patients with a non-missing value at timepoint are included in the analysis||participants|||Number
716344|NCT00266409|Secondary|Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 5 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe).|5 weeks|ITT population, but only patients with a non-missing value at timepoint are included in the analysis||participants|||Number
716345|NCT00266409|Secondary|Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 4 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe).|4 weeks|ITT population, but only patients with a non-missing value at timepoint are included in the analysis||participants|||Number
716346|NCT00266409|Secondary|Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 3 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe).|3 weeks|ITT population, but only patients with a non-missing value at timepoint are included in the analysis||participants|||Number
716347|NCT00266409|Secondary|Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 2 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe).|2 weeks|ITT population, but only patients with a non-missing value at timepoint are included in the analysis||participants|||Number
716348|NCT00266409|Secondary|Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 1 Week|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe).|1 week|ITT population, but only patients with a non-missing value at timepoint are included in the analysis||participants|||Number
716349|NCT00266409|Secondary|Change From Baseline in the Total HAM-A Score at Endpoint During the 8 Week Treatment Period|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56. Endpoint is last observed value during the 8 week treatment period.|Baseline and at endpoint during the 8 week treatment period|ITT population, Last Observation Carried Forward imputation was applied||Units on a scale||Standard Deviation|Mean
716350|NCT00266409|Secondary|Change From Baseline in the Total HAM-A Score After 8 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56.|Baseline and 8 weeks|ITT population, only subjects with non-missing values have been included||Units on a scale||Standard Deviation|Mean
716572|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest and Lowest Values in Sitting Diastolic BP During Phase 3||Baseline, During Phase 3 (for highest/lowest values), Week 52|Participants in Phase 3 Safety Sample with measurement; Week 52 LOCF||mm Hg||Full Range|Median
716351|NCT00266409|Secondary|Change From Baseline in the Total HAM-A Score After 7 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56.|Baseline and 7 weeks|ITT population, only subjects with non-missing values have been included||Units on a scale||Standard Deviation|Mean
716352|NCT00266409|Secondary|Change From Baseline in the Total HAM-A Score After 6 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56.|Baseline and 6 weeks|ITT population, only subjects with non-missing values have been included||Units on a scale||Standard Deviation|Mean
716353|NCT00266409|Secondary|Change From Baseline in the Total HAM-A Score After 5 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56.|Baseline and 5 weeks|ITT population, only subjects with non-missing values have been included||Units on a scale||Standard Deviation|Mean
716354|NCT00266409|Secondary|Change From Baseline in the Total HAM-A Score After 4 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56.|Baseline and 4 weeks|ITT population, only subjects with non-missing values have been included||Units on a scale||Standard Deviation|Mean
716355|NCT00266409|Secondary|Change From Baseline in the Total HAM-A Score After 3 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56.|Baseline and 3 weeks|ITT population, only subjects with non-missing values have been included||Units on a scale||Standard Deviation|Mean
716356|NCT00266409|Secondary|Change From Baseline in the Total HAM-A Score After 2 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56.|Baseline and 2 Weeks|ITT Population, only subjects with non-missing values have been included||Units on a scale||Standard Deviation|Mean
716357|NCT00266409|Secondary|Change From Baseline in the Total HAM-A Score After 1 Week|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56.|Baseline and 1 week|ITT population, but only subjects with values at baseline and time point are included in the analysis||Units on a scale||Standard Deviation|Mean
716358|NCT00266409|Primary|Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Intent-to-treat Population (Kaplan-Meier-estimates)|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Thus total possible score is 56. Kaplan-Meier-analysis was performed and Kaplan-Meier estimates (cumulative percent of subjects responding) are presented.|10 weeks|Intent-to-treat population||cumulative percent of responders|||Number
716359|NCT00266630|Secondary|Number of Participants With Treatment-emergent Abnormal, High, or Low Laboratory Values|High density lipoprotein: males low 40 milligram/deciliter (mg/dL), high 80 mg/dL; females low 40 mg/dL, high 90 mg/dL. Low density lipoprotein (LDL): males and females low 70 mg/dL, high 139 mg/dL. Hemoglobin A1C (HBA1C): males and females low 4.3%, high 5.8%.|baseline through 18 weeks|Analyzed were all participants who had baseline and post-baseline measurements. Last observation carried forward.||participants|||Number
716360|NCT00266630|Secondary|Number of Participants With Potentially Clinically Significant Changes in Electrocardiograms - High Fridericia Corrected QT Interval (QTcF)|High QTcF: more than or equal to 450 milliseconds (msec) for males; more than or equal to 470 milliseconds (msec) for females|baseline through 18 weeks|Analyzed were all participants who had baseline and post-baseline measurements and no abnormal values in the direction at baseline (e.g. participants with an abnormally low value for a given parameter at baseline who showed an abnormally low value for the same parameter at a later visit were not included). Last observation carried forward.||participants|||Number
716361|NCT00266630|Secondary|Number of Participants With Potentially Clinically Significant Changes in Vital Signs and Weight|Low systolic blood pressure (SBP): <=90 millimeter mercury (mmHg) and decrease of >=20 mmHg; High SBP: >=180 mmHg and increase of >=20 mmHg; Low diastolic blood pressure (DBP): <=50 mmHg and decrease of >=15 mmHg; High DBP: >=105 mmHg and increase of >=15 mmHg; Low pulse: <50 beats per minute (bpm) and decrease of >=15 bpm; High pulse: >120 bpm and an increase of >=15 bpm; Low weight: decrease of >=7%; High weight: increase of >=7%;|baseline through 18 weeks|Analyzed were all study participants.||participants|||Number
716362|NCT00266630|Secondary|Number of Participants With Potentially Clinically Significant Changes in Laboratory Analytes|Triglycerides: high limit equal to or more than 500 milligram/deciliter (mg/dL); Glucose (non-fasting): low limit 2.4975 mmol/liter (L); high limit 13.875 mmol/L; Glucose (fasting): low limit 2.4975 mmol/L; high limit 6.993 mmol/L.|baseline through 18 weeks|Analyzed were all participants without an abnormal value in the direction at baseline (for example, participants with an abnormally low value at baseline who experienced an abnormally low value at any time post baseline were not included, but were included if they experienced an abnormally high value at any time post baseline).||participants|||Number
716363|NCT00266630|Secondary|Number of Participants With Treatment-Emergent Dyskenisia Based on DIEPSS Scores|DIEPSS assesses the extrapyramidal symptoms attributable to antipsychotics. Consists of 9 items (8 to assess individual symptoms and 1 to assess global severity). Each item is assessed from 0 (none, normal) to 4 (severe). The total points of 8 items are defined as DIEPSS total (0 to 32 points). The items are classified into 4 categories of parkinsonism, akathisia, dystonia and dyskinesia. Treatment-emergent dyskenisia was defined as a score of equal or more than 2 or an increase of equal to or more than 2 points from baseline on the dyskenisia item (total score possible 0 to 4 points).|baseline through 18 weeks|Included were all participants who did not have an abnormal value at baseline.||participants|||Number
716573|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest and Lowest Values in Sitting Systolic BP During Phase 3||Baseline, During Phase 3 (for highest/lowest values), Week 52|Participants in Phase 3 Safety Sample with measurement; Week 52 LOCF||mm Hg||Full Range|Median
716364|NCT00266630|Secondary|Number of Participants With Treatment-Emergent Dystonia Based on DIEPSS Scores|DIEPSS assesses the extrapyramidal symptoms attributable to antipsychotics. Consists of 9 items (8 to assess individual symptoms and 1 to assess global severity). Each item is assessed from 0 (none, normal) to 4 (severe). The total points of 8 items are defined as DIEPSS total (0 to 32 points). The items are classified into 4 categories of parkinsonism, akathisia, dystonia and dyskinesia. Treatment-emergent dystonia was defined as a score equal or more than 2 or an increase of equal or more than 2 points from baseline on the dystonia item (total score possible 0 to 4 points).|baseline through 18 weeks|Included were all participants who did not have an abnormal value at baseline.||participants|||Number
716365|NCT00266630|Secondary|Number of Participants With Treatment-Emergent Akathisia Based on DIEPSS Scores|DIEPSS assesses the extrapyramidal symptoms attributable to antipsychotics. Consists of 9 items (8 to assess individual symptoms and 1 to assess global severity). Each item is assessed from 0 (none, normal) to 4 (severe). The total points of 8 items are defined as DIEPSS total (0 to 32 points). The items are classified into 4 categories of parkinsonism, akathisia, dystonia and dyskinesia. Treatment-emergent akathisia was defined as a score of equal or more than 2 or an increase of equal or more than 2 points from baseline on the akathisia item (total score possible 0 to 4 points).|baseline through 18 weeks|Included were all participants who did not have an abnormal value at baseline.||participants|||Number
716366|NCT00266630|Secondary|Number of Participants With Treatment-Emergent Parkinsonism Based on DIEPSS Scores|DIEPSS assesses the extrapyramidal symptoms attributable to antipsychotics. Consists of 9 items (8 to assess individual symptoms and 1 to assess global severity). Each item is assessed from 0 (none, normal) to 4 (severe). The total points of 8 items are defined as DIEPSS total (0 to 32 points). Parkinsonism is assessed by the total points of items 1 to 5 (total score of 0 to 20). Treatment-emergent parkinsonism was defined as a score of equal or greater than 3 on 1 item, equal or greater than 2 on 2 items, or an increase of equal or greater than 3 from baseline on the parkinsonism total.|baseline through 18 weeks|Included were all participants who did not have an abnormal value at baseline.||participants|||Number
716367|NCT00266630|Secondary|Maximum Change From Baseline to Endpoint on the Drug Induced Extra-Pyramidal Symptoms Scale (DIEPSS) - Total Score|A scale used to assess the extrapyramidal symptoms attributable to antipsychotics. Consists of 9 items (8 to assess individual symptoms and 1 to assess global severity). Each item is assessed from 0 (none, normal) to 4 (severe). The total points of 8 items are defined as DIEPSS total (0 to 32 points). The items for the assessment of individual symptoms are classified into 4 categories of parkinsonism, akathisia, dystonia and dyskinesia. Parkinsonism is assessed by the total points of items 1 to 5; akathisia, dystonia and dyskinesia are assessed by the points given to the corresponding items.|baseline through 18 weeks|Analyzed were all participants who had baseline and post-baseline measurements. Last observation carried forward.||units on a scale||Standard Deviation|Mean
716368|NCT00266630|Secondary|Number of Participants Who Switched to Syndromic Depression|As defined as a shift from a Manic Episode at baseline to a Major Depressive Episode, at any post baseline visit, based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Revision.|baseline through 18 weeks|Analyzed were all participants who had a manic episode at baseline.||participants|||Number
716369|NCT00266630|Secondary|Positive and Negative Syndrome Scale Positive Scores - Visit Data|Assesses positive symptoms associated with schizophrenia. 7 items make up the Positive scale. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total Positive Subscale scores range from 7 to 49. For the analysis, the score was converted to 0 to 6 for each item range; hence, the total score ranges from 0 to 42.|baseline, Weeks 1, 2, 4, 6, 10, 14, 18|Analyzed were all participants who had baseline and post-baseline measurements. Last observation carried forward.||units on a scale||Standard Deviation|Mean
716370|NCT00266630|Secondary|Number of Participants Who Experienced Remission of Bipolar Disorder|Participants who had equal to or less than 12 points in YMRS total score and equal to or less than 7 points in HAMD-17 total score at 18 weeks. YMRS: 11-item scale, measures the severity of manic episodes. 4 items are rated from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total: 0 to 60. The 17-item HAMD measures depression severity. Each item was evaluated and scored using a 3-point scale or a 5-point scale. HAMD-17 total score: 0 (normal) to 52 (severe).|Week 18|Analyzed were all participants who had baseline and post-baseline measurements. Last observation carried forward.||participants|||Number
716371|NCT00266630|Secondary|Number of Participants With Relapse of Depressive Symptoms|Assessed were participants meeting remission criteria for bipolar disorder in Study BMAC and have a HAMD-17 total score greater than or equal to 13 at any time. The 17-item HAMD measures depression severity. Each item was evaluated and scored using a 3-point scale (e.g. absent, mild, marked) or a 5-point scale (e.g. absent, mild, moderate, severe, very severe). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).|baseline through 18 weeks|Analyzed were all participants in the olanzapine monotherapy group who had 12 points or less in the YMRS total score and 7 points or less in the HAMD-17 total score at baseline.||participants|||Number
716372|NCT00266630|Secondary|Number of Participants Who Experienced Switch to Symptomatic Depression as Measured by the Hamilton Depression Scale - 17 Item Version (HAMD-17)|Incidence of depressive symptoms was defined as a score of equal to or more than 13 points on the HAMD-17. The 17-item HAMD measures depression severity. Each item was evaluated and scored a 3-point scale (e.g. absent, mild, marked) or a 5-point scale (e.g. absent, mild, moderate, severe, very severe). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).|baseline through 18 weeks|Analyzed were all participants who had equal to or less than 7 points on the HAMD-17 total score at baseline.||participants|||Number
716373|NCT00266630|Secondary|Clinical Global Impressions - Bipolar Version, Severity of Illness (CGI-BP) Overall, Visit Data|Measures severity of the patient's overall severity of bipolar symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).|baseline, Weeks 1, 2, 4, 6, 10, 14, 18|Analyzed were all participants who had baseline and post-baseline measurements. Last observation carried forward.||units on a scale||Standard Deviation|Mean
716412|NCT00268242|Primary|Duration of the First Complete Response||After a CR is achieved, patients are followed at 3 month intervals for disease progression and survival. If a patient has disease progression after achieving a CR, survival will be captured at 6 month intervals, typically for up to 5 years.|Only 5 patients had a complete response, therefore on 5 patients were analyzed for this measure.||months||Full Range|Median
716374|NCT00266630|Secondary|Change From Baseline to Endpoint on the YMRS Total Score - Olanzapine + Mood Stabilizer Only|The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.|baseline through 18 weeks|Analyzed were all participants who had baseline and post-baseline measurements. Last observation carried forward.||units on a scale||Standard Deviation|Mean
716375|NCT00266630|Primary|Number of Participants With Relapse of Manic Symptoms - Olanzapine Monotherapy Arm Only|Patients achieved remission in Study BMAC (defined as YMRS total score <=12 and HAMD-17 total score <=7) and obtained YMRS total score of >=15 at any time during Study BMEX. The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60. The primary objective was only interested in the effects in the olanzapine monotherapy arm.|baseline through 18 weeks|Analyzed were all participants in the olanzapine monotherapy group who were in remission at baseline (end of Study BMAC) with 12 points or less in YMRS total score and 7 points or less in the 17-item Hamilton Depression Rating Scale total score.||participants|||Number
716376|NCT00266630|Primary|Number of Participants With Remission of Mania - Olanzapine Monotherapy Arm Only|Remission of Mania was defined as a YMRS total score of less than or equal to 12 at endpoint. The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60. The primary objective was only interested in the effects in the olanzapine monotherapy arm.|baseline through 18 weeks|Analyzed were all participants in the olanzapine monotherapy arm who had baseline and post-baseline measurements. Last observation carried forward.||participants|||Number
716377|NCT00266630|Primary|Number of Participants With Response of Manic Symptoms - Olanzapine Monotherapy Arm Only|Defined by a 50% or more reduction in YMRS total score from baseline in Study BMAC to endpoint. The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60. The primary objective was only interested in the effects in the olanzapine monotherapy arm.|baseline through 18 weeks|Analyzed were all participants in the olanzapine monotherapy arm who had baseline and post-baseline measurements. Last observation carried forward.||participants|||Number
716378|NCT00266630|Primary|Change From Baseline to Endpoint in Young Mania Rating Scale (YMRS) Total Scores - Olanzapine Monotherapy Arm Only|The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60. The primary objective was only interested in the effects in the olanzapine monotherapy arm.|baseline through 18 weeks|The primary objective was only interested in the effects in the olanzapine monotherapy arm, thus the results for the olanzapine + mood stabilizer arm are presented as secondary outcomes. Analyzed were all participants in the olanzapine monotherapy arm who had baseline and post-baseline measurements. Last observation carried forward.||units on a scale||Standard Deviation|Mean
716379|NCT00267670|Secondary|Change in Serum Adiponectin Levels in Patients Treated With Pentoxifylline or Placebo for 12 Months||one year|||ug/mL||Standard Error|Mean
716380|NCT00267670|Secondary|Change in Serum Leptin Levels in Patients Treated With Pentoxifylline or Placebo for 12 Months|Values represent changes in leptin from baseline to 12 months in patients treated with pentoxifylline or placebo.|baseline and one year|||ng/mL||Standard Error|Mean
716381|NCT00267670|Secondary|The Effect of Pentoxifylline on Change in Tumor Necrosis Factor [TNF]-α Levels in Patients With NASH|The mean change from baseline to month 12 in proinflammatory cytokines (such as TNF-α) and gene expresssion were the secondary endpoints and were analyzed with the same analysis of covariance model and summary statistics specified for the primary endpoint. Differences were regarded as statistically significant when P < 0.05. The results for TNF-α are reported here. Interleukin-6 [IL-6], IL-10) and expression of TNF-alpha Receptors (p55 and p75) had insufficient data for statistical analysis.|one year|Intention to Treat with last observation carried forward||pg/dL||Standard Error|Mean
716382|NCT00267670|Primary|The Number of Participants With a 30% Reduction in Alanine Aminotransferase (ALT) Treated With Pentoxifylline (PTX) or Placebo for 12 Months.|The primary goal of the study was to determine whether pentoxifylline (PTX) therapy improved serum ALT (> or = 30% change from baseline to month 12) compared to placebo.|baseline and 12 months|The primary analysis was done as intention to treat. A secondary analysis was performed per protocol and there were no differences between the two analyses. Intention to treat results are reported.||participants|||Number
716383|NCT00267696|Secondary|Overall Survival for Patients Treated With the Regimen.|The period of time from study entry until disease progression or date of last contact.|To progression of Disease|||months||95% Confidence Interval|Median
716384|NCT00267696|Primary|Determine the Antitumor Activity of Gemcitabine/Carboplatin/Bevacizumab Regimen as Measured by the Probability of Surviving Progression-free for at Least 6 Months or Responding.|Progression-free survival (PFS) by RECIST, and safety. RECIST verison 1.0 was used for the assessment of progression and was based on radiologic evaluation.|up to 6 months|||months||95% Confidence Interval|Median
716385|NCT00267748|Other Pre-specified|FACT–Kidney Symptom Index for Disease Related Symptoms (FKSI-DRS)|"FKSI-DRS is a subset of FKSI which is a questionnaire for Functional Assessment of Cancer Therapy –Kidney Symptom Index used to assess QoL/participant-reported outcomes for participants diagnosed with renal cell cancer.
The FKSI contained 15 questions and the FKSI-DRS consisted of 9 questions each ranging from 0 (not at all) to 4 (very much) so that FKSI-DRS ranged between 0-36. Since the questions could be reversed coded, as appropriate, before calculating FKSI-DRS, 0 and 36 could be considered the worst and best health states based on the 9 questions comprising FKSI-DRS."|From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years|ITT population included all participants who were randomized into the study regardless of whether they received study medication.||Units on scale||Standard Deviation|Mean
716386|NCT00267748|Other Pre-specified|Functional Assessment of Cancer Therapy-General (FACT-G)|FACT-G is core questionnaire of Functional Assessment of Chronic Illness Therapy (FACIT) measurement system to evaluate quality of life (QoL) in cancer population.FACT-G consisted of 27 questions grouped in 4 domains of general Health-Related QoL(HRQoL):Physical Well-being(PWB),Social/Family Well-Being (SWB),Emotional Well-Being (EWB) and Functional Well-Being (FWB);each ranging from 0 (not at all) to 4 (very much) so that FACT-G ranged between 0-108.Since questions could be reversed coded, as appropriate, before calculating FACT-G,0 and 108 could be considered worst and best health states.|From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years|ITT population included all participants who were randomized into the study regardless of whether they received study medication.||Units on a scale||Standard Deviation|Mean
716387|NCT00267748|Secondary|Overall Survival (OS) Assessed Using MSKCC Prognostic Factors Model|MSKCC Prognostic Factor Model assessed as low (0), intermediate (1-2) or high (=>3) based upon number of criteria present. Criteria as follows: Karnofsky performance status < 80 %, Lactate dehydrogenase > 1.5 * Upper limit of Normal, Hemoglobin < lower limit of normal for local lab, Corrected serum calcium > 10 mg/dL; Time from first diagnosis of renal cell carcinoma to start of systemic therapy of < 1 year. OS was defined as time from date of start of treatment to date of death due to any cause. OS, in months, was calculated as (event date –start of treatment date + 1)/30.44.|From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years|ITT population included all participants who were randomized into the study regardless of whether they received study medication.||Months||95% Confidence Interval|Median
716388|NCT00267748|Secondary|Duration of Response (DR)|Time from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.44. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years|DR was calculated for the subgroup of participants from the ITT set, with a confirmed OR.||Months||Full Range|Median
716389|NCT00267748|Secondary|Percentage of Participants With Objective Response (OR)|Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with atleast 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years|ITT population included all participants who were randomized into the study regardless of whether they received study medication.||Percentage of participants||95% Confidence Interval|Number
716390|NCT00267748|Primary|Time to Tumor Progression (TTP) Assessed Using Memorial Sloan-Kettering Cancer Center (MSKCC) Prognostic Factors Model|MSKCC Prognostic Factor Model assessed as low(0),intermediate(1-2) or high(=>3) based on number of criteria present such as Karnofsky performance status < 80 %, Lactate dehydrogenase > 1.5 * Upper limit of Normal,Hemoglobin < lower limit of normal, serum calcium > 10 mg/dL;Time from first diagnosis of renal cell carcinoma to start of systemic therapy of < 1 year.TTP was time from start of study treatment to first documentation of objective tumor progression or death due to cancer.TTP was calculated as (first event date minus date of first dose of study medication plus 1) divided by 30.44.|From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years|The intent-to-treat (ITT) population included all participants who were randomized into the study regardless of whether they received study medication.||Months||95% Confidence Interval|Median
716391|NCT00267774|Secondary|Cost Effectiveness||Index procedure||||||
716392|NCT00267774|Primary|Major Adverse Cardiac Events||1 year|||participants|||Number
716393|NCT00267956|Secondary|Change in Dermatology Life Quality Index (DLQI) at Week 12|Change in Dermatology Life Quality Index (DLQI) from baseline at Week 12. The DLQI is a 10 item questionnaire, is designed to assess the impact of the disease on a participant’s quality of life, can be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. The score ranges from 0 (better quality of life) to 30 (worse quality of life).|Week 0 to Week 12|All participants randomized with baseline ≥ 3% body surface area psoriatic involvement were included in the analysis according to the assigned treatment groups. Zero change is imputed if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy. Other missing data were not imputed.||Scores on scale||Inter-Quartile Range|Median
716394|NCT00267956|Secondary|Number of Participants With Psoriasis Area and Severity Index (PASI) Score of 75 Percent at Week 12|Number of participants achieving greater than or equal to 75 perccentage mprovement PASI at Week 12. PASI is widely used tool for the measurement of severity of psoriasis. This is a test of how bad person's psoriasis is. The combine redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) to 72 (worst).|Week 12|All participants randomized with baseline ≥ 3% body surface area (BSA) psoriatic involvement and with evaluable measurement are included in the analysis according to the assigned treatment groups. Participant is considered a non- responder if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy.||Participants|||Number
716395|NCT00267956|Secondary|Change in Health Assessment Questionnaire (HAQ) at Week 12|The HAQ is a 20-question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area based on the worst score from the questions that pertain to that task. The HAQ score is determined by the average of the 8 scores.|Week 0 to Week 12|Participants were included in the analysis according to the assigned treatment groups. Zero change is imputed if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy. Other missing data were not imputed.||Scores on scale||Inter-Quartile Range|Median
716396|NCT00267956|Secondary|Number of Participants With an American College of Rheumatology (ACR) 70 Response at Week 12|ACR 70 response is an improvement of greater than or equal to 70 percentage in both tender and swollen joint count and in 3 to 5 assessments (patient's assessment of pain visual analog scale [VAS] with 0, no pain to 10, worst pain; patient's and physician's global assessment of disease activity VAS scales: overall disease activity [0, very well to 10, very poor and 0, no arthritis activity to 10, extremely active, respectively]; Health Assessment Questionnaire [HAQ]: 20-questions on life activities [0, no difficulty to 3, inability to perform a task]; C-reactive protein[CRP]).|Week 12|Intent to treat. All participant randomized were included in the analysis according to the assigned treatment groups. Participant is considered a non- responder if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy or participant who have no data for all ACR components at Week 12.||Participants|||Number
716397|NCT00267956|Secondary|Number of Participants With an American College of Rheumatology (ACR) 50 Response at Week 12|ACR 50 response is an improvement of greater than or equal to 50 percentage in both tender and swollen joint count and in 3 to 5 assessments (patient's assessment of pain visual analog scale [VAS] with 0, no pain to 10, worst pain; patient's and physician's global assessment of disease activity VAS scales: overall disease activity [0, very well to 10, very poor and 0, no arthritis activity to 10, extremely active, respectively]; Health Assessment Questionnaire [HAQ]: 20-questions on life activities [0, no difficulty to 3, inability to perform a task]; C-reactive protein[CRP]).|Week 12|Intent to treat. All participants randomized were included in the analysis according to the assigned treatment groups. Participant is considered a non- responder if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy or participant who have no data for all ACR components at Week 12.||Participants|||Number
716398|NCT00267956|Primary|Number of Participants With an American College of Rheumatology (ACR) 20 Response at Week 12|ACR 20 response is an improvement of greater than or equal to 20 percentage in both tender and swollen joint count and in 3 to 5 assessments (patient's assessment of pain visual analog scale [VAS] with 0, no pain to 10, worst pain; patient's and physician's global assessment of disease activity VAS scales: overall disease activity [0, very well to 10, very poor and 0, no arthritis activity to 10, extremely active, respectively]; Health Assessment Questionnaire [HAQ]: 20-questions on life activities [0, no difficulty to 3, inability to perform a task]; C-reactive protein[CRP]).|Week 0 to Week 12|Intent to treat. All participants randomized were included in the analysis according to the assigned treatment groups. Participant is considered a non- responder if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy or participant who have no data for all ACR components at Week 12.||Participants|||Number
716399|NCT00267969|Secondary|Psoriasis Area and Severity Index (PASI) 75 Responders at Week 52|The number of participants achieving at least 75% improvement from baseline in Psoriasis Area and Severity Index (PASI) (0 [best] - 72 [worst]) at Week 52 in participants randomly assigned to a treatment group at Week 40. This is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score.|Week 52|Patients were included in the analysis according to the assigned treatment groups. Patient is considered a non- responder if the patient has used any pre-specified prohibited medications or discontinued due to lack of efficacy. Other missing data were not imputed.||participants|||Number
716400|NCT00267969|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 12|Change from baseline in Dermatology Life Quality Index (DLQI) from baseline at Week 12. This DLQI is a 10-item questionnaire, that in addition to evaluating overall quality of life, can be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Scores range from 0 (no impairment in quality of life) to 30 (most impairment in quality of life).|Baseline (Week 0), Week 12|Patients were included in the analysis according to the assigned treatment groups. Zero change is imputed if the patient has used any pre-specified prohibited medications or discontinued due to lack of efficacy. Other missing data were not imputed.||Scores on a scale||Inter-Quartile Range|Median
716401|NCT00267969|Secondary|Number of Participants Who Achieved a Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12|The PGA is used to determine the participant’s psoriasis lesions overall at a given time point. Overall lesions will be graded as : (0) = cleared, (1) = minimal, (2) = mild, (3) = moderate, (4) = marked, and (5) = severe for induration, erythema, and scaling. The sum of the 3 scales will be divided by 3 to obtain a final PGA score ranging from 0 [best] to 5 [worst].|Week 12|Intent to treat. All patients were included in the analysis according to the assigned treatment groups. Patient is considered a non- responder if the patient has used any pre-specified prohibited medications or discontinued due to lack of efficacy, or an AE of worsening of psoriasis, or had missing data at Week 12.||participants|||Number
716402|NCT00267969|Primary|Psoriasis Area-and-severity Index (PASI) 75% Improvement From Baseline at Week 12.|The number of participants achieving at least 75% improvement from baseline in Psoriasis Area and Severity Index (PASI) (0 [best] - 72 [worst]) at Week 12. This is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score.|Week 12|Intent to treat. All patients randomized were included in the analysis according to the assigned treatment groups. Patient is considered a non- responder if the patient has used any pre-specified prohibited medications or discontinued due to lack of efficacy, or an AE of worsening of psoriasis, or had missing data at Week 12.||Participants|||Number
716403|NCT00268203|Secondary|Time to Treatment Failure|Time to treatment failure is defined as the time from the date of the dosimetric dose to the first occurrence of the following: treatment withdrawal, decision to seek additional therapy, study removal, disease progression, receipt of alternative therapy for lymphoma, or death study withdrawal for any reason. Participants withdrawn for reasons other than progression or death were censored at their date of withdrawal.|From the dosimetric dose to the first occurrence of the following: treatment withdrawal, decision to seek additional therapy, study removal, disease progression, receipt of alternative therapy, or death (up to 161 months)|ITT Population. Participants who did not experience treatment failure were censored at the date of their last contact.||Months||95% Confidence Interval|Median
716413|NCT00268242|Secondary|White Blood Cell Count at Time of Relapse||After a CR is achieved, patient will be followed at 3 month intervals for disease progression, typically for up to 5 years.|||cells per microliter||Full Range|Median
716404|NCT00268203|Primary|Time to Progression or Death|Time to progression is defined as the time from the treatment start date to the first documented incidence of disease progression (PD) or death. PD is defined as greater than or equal to a 50% increase from nadir in the SPPD for all measurable disease. Lesion changes believed to represent measurement variation associated with radiographic technique should not be classified as PD.|From the treatment start date to the first documented incidence of disease progression (PD) or death (up to 161 months)|ITT Population. Participants who did not have disease progression or death were censored in the analysis at the date of their last contact.||Months||95% Confidence Interval|Median
716405|NCT00268203|Primary|Duration of Response (DOR) in Confirmed Complete Responders|DOR is defined as the time from the first documented response to the first documented disease progression. CR is defined as the disappearance of all detectable clinical and radiographic evidence of disease and all disease-related symptoms. A confirmed response (CR and PR) requires that the response be confirmed by another response (same or better) at least 4 weeks apart.|From the time of the first documented CR until PD (up to 161 months)|ITT Population. Only those participants with a confirmed CR were included in this analysis of duration of response. Participants who did not have disease progression were censored in the analysis at the date of their last contact.||Months||95% Confidence Interval|Median
716406|NCT00268203|Primary|Duration of Response (DOR) in Unconfirmed Complete Responders|DOR is defined as the time from the first documented response to the first documented disease progression. Unconfirmed CR is defined as the disappearance of all detectable clinical and radiographic evidence of disease and all disease-related symptoms. Response was evaluated by an investigator per guidelines developed by The International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma.|From the time of the first documented unconfirmed CR until PD (up to 161 months)|ITT Population. Only those participants with an unconfirmed CR were included in this analysis of duration of response. Participants who did not have disease progression were censored in the analysis at the date of their last contact.||Months||95% Confidence Interval|Median
716407|NCT00268203|Primary|Duration of Response for Participants With Confirmed Response (CR+PR)|Duration of response is defined as the time from the first documented CR (the disappearance of all detectable clinical and radiographic evidence of disease and all disease-related symptoms) or PR (greater than or equal to a 50% decrease in the SPPD determined at Baseline; no increase in the size of the other nodes, liver, or spleen; no new sites of disease) until disease progression (PD). PD is defined as greater than or equal to a 50% increase from nadir in the SPPD for all measurable disease. Lesion changes believed to represent measurement variation associated with radiographic technique should not be classified as PD. Response was evaluated by an investigator per guidelines developed by the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma. A confirmed response (CR and PR) requires that the response be confirmed by another response (same or better) at least 4 weeks apart.|From the time of the first documented response (CR or PR) until disease progression (up to 161 months)|ITT Population. Only those participants with a confirmed CR or PR were analyzed for duration of confirmed response. Participants who did not have disease progression were censored in the analysis at the date of their last contact.||Months||95% Confidence Interval|Median
716408|NCT00268203|Primary|Duration of Response for Participants With Unconfirmed Response (CR+PR)|Duration of response is defined as the time from the first documented CR (the disappearance of all detectable clinical and radiographic evidence of disease and all disease-related symptoms) or PR (greater than or equal to a 50% decrease in the SPPD determined at Baseline; no increase in the size of the other nodes, liver, or spleen; no new sites of disease) until disease progression (PD). PD is defined as greater than or equal to a 50% increase from nadir in the SPPD for all measurable disease. Lesion changes believed to represent measurement variation associated with radiographic technique should not be classified as PD. Response was evaluated by an investigator per guidelines developed by the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma.|From the time of the first documented response (CR or PR) until disease progression (up to 161 months)|ITT Population. Only those participants with an unconfirmed CR or PR were analyzed for duration of unconfirmed response. Participants who did not have disease progression were censored in the analysis at the date of their last contact.||Months||95% Confidence Interval|Median
716409|NCT00268203|Primary|Number of Participants With Confirmed Response (Complete Response or Partial Response) and Confirmed Complete Response|A participant was defined as a responder if he/she sustained a complete response (CR: the disappearance of all detectable clinical and radiographic evidence of disease and all disease-related symptoms) or partial response (PR: greater than or equal to a 50% decrease in the sum of the product of perpendicular diameter [SPPD] determined at Baseline; no increase in the size of the other nodes, liver, or spleen; no new sites of disease). Response was evaluated by an investigator per guidelines developed by The International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma. A confirmed response (CR and PR) requires that the response be confirmed by another response (same or better) at least 4 weeks apart.|From randomization until the first documented complete response or partial response (up to 161 months)|Intent-to-Treat (ITT) Population: participants receiving any study drug. Only those participants evaluable for confirmed response (those with at least one response assessment) were analyzed.||Participants|||Number
716410|NCT00268203|Primary|Number of Participants With Unconfirmed Response (Complete Response or Partial Response) and Unconfirmed Complete Response|A participant was defined as a responder if he/she sustained a complete response (CR: the disappearance of all detectable clinical and radiographic evidence of disease and all disease-related symptoms) or partial response (PR: greater than or equal to a 50% decrease in the sum of the product of perpendicular diameter [SPPD] determined at Baseline; no increase in the size of the other nodes, liver, or spleen; no new sites of disease). Response was evaluated by an investigator per guidelines developed by The International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma.|From randomization until the first documented complete response or partial response (up to 161 months)|Intent-to-Treat (ITT) Population: participants receiving any study drug. Only those participants evaluable for unconfirmed response (those with at least one response assessment) were analyzed.||Participants|||Number
716411|NCT00268242|Secondary|Percentage of Patients Making it to Bone Marrow Transplant.|Assessing the number of patients who were able to have protocol treatment and have a bone marrow transplant after treatment.|After completion of protocol therapy|||percentage of Patients completed a BMT|||Number
716414|NCT00268242|Secondary|Laboratory Correlates: Immunohistochemistry|"Percentage of patients who had a moderate-strong (2-3+) expression of multidrug resistance (MDR) genes by immunohistochemistry.
Multidrug resistance gene 1 (MDR1)
Equilibrative nucleoside transporter 2(SLC29A2)"|Baseline|23 of 24 patients had available blocks for Immunohistochemical (IHC) analysis; Participants with the SLC29A2 Gene Expression (n=22)||percentage of participants|||Number
716415|NCT00268242|Secondary|Disease-free and Overall Survival||After a CR is achieved, patients are followed at 3 month intervals for disease progression and survival. If a patient has disease progression after achieving a CR, survival will be captured at 6 month intervals, typically for up to 5 years.|1 patient died on day 1 of protocol therapy (secondary to complications from AML).||participants|||Number
716416|NCT00268242|Primary|Complete Response Rate|Assumptions/ hypothesis: A Complete Response (CR) rate of 30% or less is unacceptable, and 50% or more is promising. A two-stage design will be used. Initially, 18 patients will be enrolled. If 5 or fewer achieve CR, the study will be stopped. Otherwise, an additional 22 patients will be accrued. Accrual was not halted while follow-up of the first 18 evaluable patients was under way. Therefore, 24 patients were enrolled. Four weeks is anticipated for observation for response. Only 5 patients (21%) achieved a CR and therefore, the study was terminated. Since response was assessed using the International Working Group criteria, a complete response was determined by Morphologic complete remission: A CR designation requires that the patient achieve the morphologic leukemia-free state and have an absolute neutrophil count of more than 1,000/μL and platelets of ≥ 100,000/μL, a cytogenic CR and a morphologic CR with incomplete blood count recovery (CRi).|4 Weeks|A total of 5 patients (21%) achieved a complete response.||participants|||Number
716417|NCT00268346|Primary|The Number of Patients With Complete or Partial Response Rate of Single Agent ZD1839 in a Patient Population With Recurrent or Metastatic Cancer of the Esophagus or Gastroesophageal Junction, Using the RECIST 1.0 Criteria.|The overall response is the number of patients with the best response recorded in measurable disease (target lesions) from start to disease progression.Complete response is the number of patients with the disappearance of all target lesions. Partial response is the number of patients with larger than or equal to 30% decrease in sum of the longest diameters from baseline. Progressive disease is larger than or equal to 20% increase in sum of the longest diameters over the smallest sum observed or appearance of new lesions. Stable disease is neither PR nor PD criteria met.|at 8 weeks after initiation of treatment|All patients enrolled were analyzed||participants|||Number
716418|NCT00268437|Secondary|Overall Survival|Time from registration to death due to any cause.|From baseline to 4 years|||months||95% Confidence Interval|Median
716419|NCT00268437|Primary|Pathologic Complete Response Rate|The proportion of pathologic complete responses will be estimated by the number of pathologic complete responses divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the true pathologic complete response rate will be calculated. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for Measurable disease is defined as at least one lesion whose longest diameter can be accurately measured as ≥2.0 cm with conventional techniques or as ≥1.0 cm with spiral CT. Lesions on chest x-ray are acceptable as measurable lesions when they are clearly defined and surrounded by aerated lung. However, CT is preferable.|Baseline to time of surgery (around 10 – 18 weeks post-baseline)|||percentage of participants||95% Confidence Interval|Number
716420|NCT00268463|Secondary|Quality of Life as Measured by the Functional Assessment of Cancer Therapy Trial Outcome Index at Baseline, at 4-6 Weeks Following Surgery (Before Initiation of Chemotherapy), and Periodically During Study||Prior to randomization, 4-6 weeks after surgery, 18 weeks after the start of chemotherapy and after completion of chemotherapy||||||
716421|NCT00268463|Secondary|Scales Specific to Social/Family, Emotional, and Functional Well-being, Perceived Convenience of Care, and Self-reported Symptoms||Prior to randomization, 4-6 weeks after surgery, 18 weeks after starting chemotherapy and after completion of chemotherapy||||||
716422|NCT00268463|Secondary|Survival as Measured by Time to Death From Any Cause.||Time from randomization through year 5||||||
716423|NCT00268463|Secondary|Liver PFI as Measured by Time to Hepatic Progression.||Time from randomization through year 5||||||
716424|NCT00268463|Primary|Progression-free Interval (PFI)|Time to first recurrence of colon cancer at any site|Time from randomization through year 5||||||
716425|NCT00268762|Secondary|Arterial Complete Recanalization at 24 Hours Post tPA Bolus|Complete recanalization at 24 hours post tPA bolus as measured by either transcranial Doppler ultrasound or CT-Angiography.|24 hours from tPA bolus|||percent of patients|||Number
716426|NCT00268762|Secondary|Arterial Complete Recanalization at 2 Hours Post tPA Bolus|Complete Recanalization as measured by either transcranial Doppler Ultrasound at 2 hours post tPA bolus.|2 hours complete recanalization post tPA bolus|||percent of patients|||Number
716427|NCT00268762|Primary|Symptomatic and Radiographic Intracerebral Hemorrhage|"Significant intracerebral hemorrhage as defined by either:
Symptomatic intracerebral hemorrhage or
Parenchymal hematoma type 2."|Within 7 days of enrollment|||percentage of patients||95% Confidence Interval|Number
716428|NCT00268892|Primary|Liver Function Tests|The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases >3x ULN and ALT increases >3x ULN with concurrently increased bilirubin >1.5 ULN.|4.5 years|||participants|||Number
716429|NCT00268892|Primary|Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight|This outcome measure included incidence of markedly abnormal values in blood pressure (systolic and diastolic), pulse, and body weight during the trial. The table presents the number of participants with a normal baseline value and at least one post-baseline markedly abnormal value.|Baseline and up to 4.5 years|The data include data from participants participating in both the main study (FE200486 CS15) and the extension study FE200486 CS15A.||participants|||Number
716430|NCT00268905|Secondary|Percent of Subjects With Best Overall Response as Measured by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria.|Objective response measured by Response Evaluation Criteria In Solid Tumors (RECIST) criteria and is Complete Response (disappearance of all target lesions) plus Partial Response (at least 30% decrease in sum of longest diameter [LD] of target lesions compared baseline sum of LD).|From start of eribulin treatment until disease progression or death|Efficacy Evaluable Population||percentage of subjects|||Number
716431|NCT00268905|Secondary|Safety of Eribulin Mesylate in Combination With Carboplatin as Measured by the Number of Subjects With Treatment Emergent Adverse Events.|Adverse events were considered treatment emergent if they started on or after the date of administration of the first dose of study drug, or if they were present prior to the administration of the first dose of study drug and increased in severity during the study.|Throughout the entire study|Safety Evaluable Population||participants|||Number
716432|NCT00268905|Primary|Maximum Tolerated Dose (MTD) of Eribulin Mesylate of E7389 in Combination With Carboplatin in Subjects With Advanced Solid Tumors.|MTD was established by summarizing the number and percent of subject with dose- limiting toxicities (DLTs) for the first cycle.|21 days (first cycle)|||mg/m^2|||Number
716433|NCT00268983|Secondary|Number of Participants With Any Serious Adverse Event (SAE) and Non-serious Adverse Event (AE)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant temporally associated with the use of a medicinal product, whether or not it is considered related to the medicinal product. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is a Grade 4 (life threatening or disabling) non-hematologic laboratory abnormality assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|From randomization through Week 26|ITT-Exposed Population||Participants|||Number
716434|NCT00268983|Secondary|Number of Participants With Myelodysplasia/Leukemia|The cumulative incidence of myelodysplasia/leukemia was estimated.|From the date of randomization to the first occurrence of progressive disease, death, or additional Non-Hodgkins Lymphoma (median follow-up for the Rituximab and TST/I-131 TST groups was 62 and 91.5 months, respectively)|ITT-Exposed Population||Participants|||Number
716435|NCT00268983|Secondary|Number of Hospitalizations|The frequency of hospitalizations within 90 days of treatment was summarized. Because too few evaluable participants were enrolled/treated, analysis of the number of hospitalizations was not conducted as planned.|Time of treatment until 90 days post-treatment|ITT-Exposed Population|||||
716436|NCT00268983|Secondary|Number of Participants With an Infusion Reaction|An infusion reaction is defined as any adverse event that occured within 24 hours of an infusion. An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product|First 24 hours of study drug administration.|ITT-Exposed Population||participants|||Number
716437|NCT00268983|Secondary|Number of Participants That Developed Hypothyroidism|Hypothyroidism is defined as elevated Thyroid-Stimulating Hormone (TSH) or current history of using thyroid medication. The frequency of hypothyroidism at study enrollment will be determined, and participants with hypothyroidism at Baseline were excluded from analysis.|From the date of randomization to the first occurrence of progressive disease, death, or additional Non-Hodgkins Lymphoma (median follow-up for the Rituximab and TST/I-131 TST groups was 62 and 91.5 months, respectively)|ITT-Exposed Population||Participants|||Number
716438|NCT00268983|Secondary|Duration of Grade 3/4 Toxicity for the Indicated Hematological Parameters|Duration of Grade 3/4 toxicity is defined as the time between the date of the first Grade 3/4 lab result to the first lab date with a Grade of 0, 1, or 2 result. Laboratory abnormalities will be recorded as AEs using NCI CTCAE, Version 3, if they are associated with clinical squeal and/or require an intervention. Specific AEs not listed in the NCI criteria will be graded as follows: 1. Mild: An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities, 2. Moderate: An event that is sufficiently discomforting to interfere with normal everyday activities, 3. Severe: An event that prevents normal everyday activities, 4. Life-threatening or debilitating, and 5. Death|Time from study randomization to 120 days after study drug administration|ITT-Exposed Population. Participants with a Grade 3/4 toxicity level for the indicated hematological parameters were analyzed (reflected by n=X, X). Different participants may have been analyzed for different parameters; thus, the overall number analyzed reflects everyone in the ITT-Exposed Population.||Days||Full Range|Median
716439|NCT00268983|Secondary|Time to Recovery to Baseline Grade for the Indicated Hematological Parameters|Hematologic nadir is defined as the lowest hematology value within 120 days of study drug administration. Time to recovery to Baseline grade is defined as the number of days from the last administration of study drug to a post-nadir hematology value of unmaintained Baseline grade or lower.|Time from study randomization to 120 days after study drug administration|ITT-Exposed Population||Days||95% Confidence Interval|Median
716440|NCT00268983|Secondary|Time to Nadir Values for the Indicated Hematological Parameters|Hematologic nadir is defined as the lowest hematology value within 120 days of study drug administration. Time to nadir is defined as the number of days from the last administration of study drug to nadir.|Time from study randomization to 120 days after study drug administration|ITT-Exposed Population||Days||Standard Deviation|Mean
716441|NCT00268983|Secondary|Hematologic Nadir for Platelet Count and White Blood Cell (WBC) Count|Hematologic nadir is defined as the lowest hematology value within 120 days of study drug administration.|Time from study randomization to 120 days after study drug administration|ITT-Exposed Population||10^3/microliter (µL)||Full Range|Median
716442|NCT00268983|Secondary|Hematologic Nadir for Hemoglobin|Hematologic nadir is defined as the lowest hematology value within 120 days of study drug administration.|Time from study randomization to 120 days after study drug administration|ITT-Exposed Population||Grams per deciliter (G/dL)||Full Range|Median
716443|NCT00268983|Secondary|Hematologic Nadir for Absolute Neutrophil Count|Hematologic toxicity includes the analysis of hematologic nadir, which is defined as the lowest hematology value within 120 days of study drug administration.|Time from study randomization to 120 days after study drug administration|ITT-Exposed Population excluding participants that did not have data within the 120 days of study drug administration.||10^3/cubic millimeter (mm^3)||Full Range|Median
716444|NCT00268983|Secondary|Time to Next Treatment|Time to next treatment is defined as time from the date of randomization until the new treatment is needed for NHL. Because too few evaluable participants were enrolled/treated, analysis of the time to next treatment was not conducted as planned.|Time from study randomization to 120 days after study drug administration|ITT-Exposed Population|||||
716445|NCT00268983|Secondary|Number of Participants Who Had Died by the Month Indicated|The median time to death could not be calculated for participants in either treatment group; thus, data are shown as the number of participants who had died by the month indicated.|From first dose of treatment until disease progression or death, whichever came first (median follow-up for the Rituximab and TST/I-131 TST groups was 62 and 91.5 months, respectively)|ITT-Exposed Population||participants|||Number
716446|NCT00268983|Secondary|Time to Death|"Time to death is defined as the time from treatment start to the date of death. As a median time to death is not presented for either group, see the outcome measure entitled Number of Participants Who Had Died by the Month Indicated for data regarding time to death."|From first dose of treatment until disease progression or death, whichever came first (median follow-up for the Rituximab and TST/I-131 TST groups was 62 and 91.5 months, respectively)|ITT-Exposed Population||months||95% Confidence Interval|Median
716447|NCT00268983|Secondary|Duration of Response|Response duration is defined as the time from the first documented response (complete response, complete response unconfirmed, or partial response) until disease progression. Partial response is defined as at least a 50% decrease in the product of two perpendicular diameters of all measurable lesions; no increase in the size of other nodes, liver, or spleen; and no new disease sites.|Participants were followed for response at Week 7, Week 13, every 3 months for the first and second year, every 6 months for the third year, and then annually|ITT-Exposed Population. Only those participants with confirmed or unconfirmed complete response or partial response were analyzed for duration of response.||months||95% Confidence Interval|Median
716448|NCT00268983|Secondary|Number of Participants Achieving Response|Complete response (CR) is defined as the complete disappearance of all detectable clinical and radiographic evidence of disease and the disappearance of all disease-related symptoms (by the IWSRC) if present before therapy, and normalization of those biochemical abnormalities definitely assignable to NHL. Confirmation of response was carried out by an independent reviewer|Participants were followed for response at Week 7, Week 13, every 3 months for the first and second year, every 6 months for the third year, and then annually|ITT-Exposed Population||Participants|||Number
716449|NCT00268983|Primary|Progression-free Survival|Progression-free survival is defined as the time from the initial date of dosing to the first documented disease progression or death. Disease assessment was based on the International Workshop to Standardize Response Criteria (IWSRC) for Non-Hodgkin's Lymphoma (NHL). Progression is defined as at least a 50% increase in the sum of the perpendicular diameters of all measurable lesions and the appearance of new lesions at least 1.4 centimeters (cm) x 1.4 cm (i.e., 2.0 cm^2) by radiographic evaluation or greater than 1.0 cm by palpation upon physical examination.|From first dose of treatment until disease progression or death, whichever came first (median follow-up for the Rituximab and TST/I-131 TST groups was 62 and 91.5 months, respectively)|ITT-Exposed Population||months||95% Confidence Interval|Median
716450|NCT00268983|Primary|Event-free Survival (EFS)|Event-free survival is defined as the time from the date of randomization to the first occurrence of (whichever came first) progressive disease, death, or additional Non-Hodgkins Lymphoma (NHL) therapy due to disease-related symptoms, threatened end-organ function, cytopenias secondary to NHL, massive bulk disease, or steady progression over at least 6 months. Progressive disease is defined as at least a 50% increase in the sum of the perpendicular diameters of all measurable lesions and the appearance of new lesions at least 1.4 centimeters (cm) x 1.4 cm (i.e., 2.0 cm^2) by radiographic evaluation or greater than 1.0 cm by palpation upon physical examination.|From the date of randomization to the first occurrence of progressive disease, death, or additional Non-Hodgkins Lymphoma (median follow-up for the Rituximab and TST/I-131 TST groups was 62 and 91.5 months, respectively)|Intent-to-Treat (ITT)-Exposed Population: all participants who received at least one dose of treatment||Months||95% Confidence Interval|Median
716451|NCT00269113|Secondary|Time to Next Treatment - Percentage of Participants Who Did Not Need New Treatment at 24 Months|Time to next treatment was defined as the interval from randomization date to the time when new treatment was needed. Data were analyzed by means of Kaplan-Meier estimators and log-rank tests at the significance level of alpha=5% for difference between the treatment groups.|Month 24|ITTcbcc/FL Population||percentage of participants|||Number
716452|NCT00269113|Secondary|Response Duration - Percentage of Participants Event Free at 24 Months|Response duration defined as interval from first assessment of CR/PR to PD. PD is an increase in the frequency and severity of disease symptoms, occurrence of new nodal or extranodal lymphoma manifestations, volume increase of pre-existing lymphoma manifestations by more than 25%, increase of splenomegaly by more than 25%. Data were analyzed by means of Kaplan-Meier estimators and log-rank tests at the significance level of alpha=5% for difference between the treatment groups.|Month 24|ITTcbcc/FL Population||percentage of participants|||Number
716453|NCT00269113|Secondary|Disease-Free Survival (DFS) - Percentage of Participants Event Free at 24 Months|DFS was defined as the interval from first assessment of CR to PD. PD is an increase in the frequency and severity of disease symptoms, the occurrence of new nodal or extranodal lymphoma manifestations, the volume increase of pre-existing lymphoma manifestations by more than 25%, increase of splenomegaly by more than 25%. Data were analyzed by means of Kaplan-Meier estimators and log-rank tests at the significance level of alpha=5% for difference between the treatment groups.|Month 24|ITTcbcc/FL Population||percentage of participants|||Number
716454|NCT00269113|Secondary|Event-Free Survival (EFS) - Percentage of Participants Event Free at 24 Months|EFS was defined as the interval from randomization date to therapy failure. Therapy failure was defined after 2 cycles as no change (NC) or progression of disease (PD); after 6 cycles as minimal response [MR], NC, or PD); or death from any cause. NC is defined as tumor regression of <25%, stable disease and progression ≤25%. PD was defined as the increase in the frequency and severity of disease symptoms, occurrence of new nodal or extranodal lymphoma manifestations, volume increase of pre-existing lymphoma manifestations by more than 25%, and increase of splenomegaly by more than 25%. MR was defined as tumor regression between 50% (<50%) and 25% (≥25%) for at least 4 weeks without occurrence of new manifestations. Data were analyzed by means of Kaplan-Meier estimators and log-rank tests at the significance level of alpha=5% for difference between the treatment groups.|Month 24|ITTcbcc/FL Population||percentage of participants|||Number
716455|NCT00269113|Secondary|Overall Survival (OS) - Percentage of Participants Alive at 24 Months|OS was defined as interval from randomization to date of death of any cause. Data were analyzed by means of Kaplan-Meier estimators and log-rank tests at the significance level of alpha=5% for difference between the treatment groups.|Month 24|ITTcbcc/FL Population||percentage of participants|||Number
716456|NCT00269113|Secondary|Progression-Free Survival (PFS) - Percentage of Participants Event Free at 24 Months|PFS was defined as the interval from randomization date to progression of disease or death from non-Hodgkin's Lymphoma (NHL). Progression of disease was defined as: increase in the frequency and severity of disease symptoms; occurrence of new nodal or extranodal lymphoma manifestations; volume increase of pre-existing lymphoma manifestations by more than 25%; or increase of splenomegaly by more than 25%. Data were analyzed by means of Kaplan-Meier estimators and log-rank tests at the significance level of alpha equals (=) 5% for difference between the treatment groups.|24 months|ITTcbcc/FL Population||percentage of participants|||Number
716457|NCT00269113|Primary|Percentage of Participants Achieving CR or PR at the End of Therapy|CR was defined as a complete remission of all objective medical findings at the time of restaging, with complete resolution of pre-existing swelling of the lymph nodes, as well as a pre-existing hepatomegaly and splenomegaly, for at least 4 weeks. This was in exclusion of persistent lymphoma infiltration of the bone marrow by means of bone marrow biopsy; normalization of blood counts with granulocytes greater than (>)1.5 giga particles per liter (Gpt/L) (which is the equivalent of 10^9/L), hemoglobin (Hb) >7.5 millimoles per liter (mmol/L), and platelets less than (<) 100 Gpt/L. PR was defined as greater than or equal to (≥)50 percent (%) reduction of all measurable and evaluable lymphoma manifestations (sum of the products of the 2 largest perpendicular diameters) for at least 4 weeks without occurrence of new manifestations and normalization of blood counts.|Following completion of 6 cycles (24 weeks)|The ITT centroblastic-centrocytic (cbcc)/Follicular Lymphoma (FL) (collectively, ITTcbcc/FL) population included all participants in the ITT population with cbcc lymphoma (target population).||percentage of participants||95% Confidence Interval|Number
716458|NCT00269152|Secondary|Overall Survival at 6 Years|For each treatment arm, the Kaplan-Meier technique was used to estimate the 6 year survival rate. Results are presented as probability (%) of survival at 6 years. Overall survival is the duration from enrollment to death. For participants not known to have died, overall survival was censored at the last known alive date.|Baseline to date of death from any cause assessed at 6 years|All randomized participants. Intent to treat population.||percent probability of survival (%)||95% Confidence Interval|Number
716459|NCT00269152|Secondary|3 Year Disease-Free Survival: Probability of Disease-Free Survival at 3 Years|For each treatment arm, the Kaplan-Meier technique was used to estimate the 3 year disease-free rate. Disease-free survival is defined as the time from enrollment to the first observation of disease progression, or death due to any cause. For participants not known to have died and to have had recurrent disease, disease-free survival was censored at the date of the last participant contact with No Recurrence status. Results are presented as probability (%) of disease-free survival at 3 years.|length of time disease free, assessed at 3 years|All randomized participants. Intent to Treat population.||probability of disease-free survival (%)||95% Confidence Interval|Number
716460|NCT00269152|Secondary|Overall Survival at 3 Years|For each treatment arm, the Kaplan-Meier technique was used to estimate the 3 year survival rate. Results are presented as probability (%) of survival at 3 years. Overall survival is the duration from enrollment to death. For participants not known to have died, overall survival was censored at the last known alive date.|baseline to date of death from any cause, assessed at 3 years|All randomized participants. Intent to treat population.||percent probability of survival (%)||95% Confidence Interval|Number
716461|NCT00269152|Secondary|Grade III/IV Adverse Events|Number of participants experiencing Grade III/IV hematologic and non-hematologic adverse events possibly related to study drug or protocol procedures in this study.|every 21-day cycle for 4 cycles|Number of participants in safety population, that is, number of participants enrolled, randomized and treated with at least one dose of study drug (presented by treatment received arm).||participants|||Number
716462|NCT00269152|Primary|The Feasibility of Post-Surgery Chemotherapy|Feasibility was measured by completion of 4 treatment cycles without remaining toxicities >=Grade 3 at 30 days after last infusion.|every 21-day cycle for 4 cycles up to 30 days after last infusion|Number of participants in safety population, that is, number of participants enrolled, randomized and treated with at least one dose of study drug (presented by treatment received arm).||participants|||Number
716463|NCT00269477|Other Pre-specified|Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions|Solicited injection site reactions: Erythema, Swelling, and Pain. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.|Day 0 to 7 post-vaccination|Safety analysis was on all enrolled and vaccinated participants, intend-to-treat population||Participants|||Number
716464|NCT00269477|Primary|Participants With Serum Bactericidal Activity of ≥ 1:8 for Each Menactra® Vaccine Serogroups Pre-vaccination and 28 Days Post-booster or Post-primary Dose Vaccination.|"Groups 1 and 2 received booster vaccination, Groups 3 and 4 received primary vaccination.
Serum bactericidal activity for each Menactra® vaccine serogroups were at pre-vaccination and at 28 days post-booster or post-primary vaccination."|28 days post-vaccination (5 years after Menactra® or Menomune® vaccination)|SBA-BR titer for each of the 4 meningococcal serogroups in the vaccine was evaluated in the per-protocol population.||Participants|||Number
716465|NCT00269633|Primary|Structured Interview Guide for the Hamilton Depression Scale - Seasonal Affective Disorder Version (SIGH-SAD); Weekly for Three Weeks|Outcome for Structured Interview Guide for the Hamilton Depression Scale - Seasonal Affective Disorder Version (SIGH-SAD) reported is the average over 3 weeks. Lower values represent less depressive symptoms. Range is 0-53.|Averaged over Three Weeks During Treatment|||units on a scale||Standard Deviation|Mean
716466|NCT00269919|Secondary|Total Drug Induced Extra-Pyramidal Symptoms Scale (DIEPSS) Score|A scale used to assess the extrapyramidal symptoms attributable to antipsychotics. It consists of 9 items (8 to assess individual symptoms and 1 to assess global severity). Each item is assessed from 0 (none, normal) to 4 (severe). The total score is the sum of the 8 item scores, for a total range of 0 (normal) to 32 (severe). The items for the assessment of individual symptoms are classified into 4 categories of parkinsonism, akathisia, dystonia and dyskinesia.|Baseline and Week 96|The safety analysis population included all the participants who participated in the clinical trial and received at least 1 dose of risperidone long acting injection (RLAI). Here, ‘N'=the participants who were evaluated for this outcome measure and ‘n'=the participants who were evaluated for this outcome measure at given time point.||Units on a scale||Standard Deviation|Mean
716543|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in Total Bilirubin, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement||mg/dL||Full Range|Median
716467|NCT00269919|Secondary|Change From Baseline in Drug Attitude Inventory-10 (DAI-10) Item Scale Score at Week 96|The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of medication and 2) attitudes and beliefs toward neuroleptics which may influence medication compliance in schizophrenia participants. It is the binary scale assessing the participant's subjective response. A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive subjective response (SR); a negative sum of scores indicates a negative SR (non-compliant). The final score for each person at each time is the positive score minus the negative score.|Baseline and Week 96|The ITT analysis population included all the participants who received at least 1 dose of study medication, satisfied the eligibility criteria and provided at least 1 post-baseline efficacy measurement. Here, ‘N'=the participants who were evaluated for this outcome measure.||Units on a scale||Standard Deviation|Mean
716468|NCT00269919|Secondary|Liverpool University Neuroleptic Side Effect Rating Scale (LUNSERS) Score|"The LUNSERS is a self-report measure of antipsychotic side effects. It consists of 51 questions, 41 questions on side effects and 10 questions are of red herrings to validate the results. Each question is rated on a 4-point scale, where 0=not at all; and 4=very much. The total neuroleptic side effect score is the sum of the scores for the side effects items (i.e. all items excluding the red herrings). Total side effects score ranges from 0 to 164, where 0 to 40=low side effect rating, 41 to 80=medium side effect rating and greater than 81=high side effect rating."|Baseline and Week 96|The safety analysis population included all the participants who participated in the clinical trial and received at least 1 dose of RLAI. Here, ‘N'=the participants who were evaluated for this outcome measure and ‘n'=the participants who were evaluated for this outcome measure at given time point.||Unit on a scale||Standard Deviation|Mean
716469|NCT00269919|Secondary|Change From Baseline in NCFT: TMT-Error at Week 96|TMT is attention, mental flexibility, visual search, motor function measure test. Test is divided into A and B types. Participants using a pencil or connect numbers in sequence (A-type), in turn, alternating between numbers and letters must be connected (B-type). The test measures the the number of errors.|Baseline and Week 96|"The ITT analysis population included all participants who received at least 1 dose of study medication, satisfied all eligibility criteria and provided at least 1 post-baseline efficacy measurement. Here, N is the number of participants evaluated for this outcome measure."||Errors||Standard Deviation|Mean
716470|NCT00269919|Secondary|Change From Baseline in NCFT: Trail Making Test (TMT)-Time at Week 96|TMT is attention, mental flexibility, visual search, motor function measure test. Test is divided into A and B types. Participants using a pencil or connect numbers in sequence (A-type), in turn, alternating between numbers and letters must be connected (B-type). The test measures the response time.|Baseline and Week 96|"The ITT analysis population included all participants who received at least 1 dose of study medication, satisfied all eligibility criteria and provided at least 1 post-baseline efficacy measurement. Here, N is the number of participants evaluated for this outcome measure."||Seconds||Standard Deviation|Mean
716471|NCT00269919|Secondary|Change From Baseline in NCFT: Memory Quotient (MQ) at Week 96|MQ was obtained by adding up the results of verbal memory and visual memory test. The memory quotient will include learning curve, memory retention, retrieval efficiency, drawing/memory consistency, verbal/visual memory consistency and intelligence/memory consistency. The highest MQ is 160, which indicates excellent memory.|Baseline and Week 96|"The ITT analysis population included all participants who received at least 1 dose of study medication, satisfied all eligibility criteria and provided at least 1 post-baseline efficacy measurement. Here, N is the number of participants evaluated for this outcome measure."||MQ||Standard Deviation|Mean
716472|NCT00269919|Secondary|Change From Baseline in NCFT: Rey Kim Memory Test- Korean-Rey Complex Figure Test (K-RCFT) at Week 96|The RCFT is a neuropsychological assessment designed to evaluate visual memory in participants. The RCFT is useful in evaluating the spatial perception and visual memory. The RCFT consists of 3 test conditions: Copy, Immediate Recall and Delayed Recall. At the first step, participants are given the RCFT stimulus card, and then asked to draw the same figure. Subsequently, they are instructed to draw what they remembered. Then, after a delay of 30 min, they are required to draw the same figure once again, a score of 2 points for each drawn element (a complete straight line or a circle) remembered correctly. The total score is the sum of points scored for each correctly drawn element and it ranges from 0 to 36. The maximum score indicates excellent visual memory.|Baseline and Week 96|The ITT analysis population included all participants who received at least 1 dose of study medication, satisfied all eligibility criteria and provided at least 1 post-baseline efficacy measurement.||Units on a scale||Standard Deviation|Mean
716473|NCT00269919|Secondary|Change From Baseline in NCFT: Rey Kim Memory Test-Korean Auditory Verbal Learning Test (KAVLT) at Week 96|The KAVLT is a neuropsychological assessment designed to evaluate verbal memory in participants. The KAVLT is useful in evaluating the nature and severity of memory dysfunction and to track changes in memory function over time. The test is designed as a list-learning paradigm in which the participants hears a list of 15 words, and are asked to recall as many words from the list as possible. This procedure is carried out a total of 5 times. Then a second list of 15 words is presented, allowing the participants only 1 attempt to recall. Immediately following this, the participants are asked to remember as many words as possible from the first list. KAVLT consists of 2 test conditions: Delayed Recall and Delayed Recognition. The upper limit for ‘words recalled’ is 15, which represents better episodic memory.|Baseline and Week 96|The ITT analysis population included all participants who received at least 1 dose of study medication, satisfied all eligibility criteria and provided at least 1 post-baseline efficacy measurement.Here ‘N'=participants who were evaluated for this outcome measure and ‘n'=participants who were evaluated for this outcome measure at given time point.||Words recalled||Standard Deviation|Mean
716474|NCT00269919|Secondary|Change From Baseline in NCFT: Controlled Oral Word Association Test at Week 96|The Controlled Oral Word Associated Test is a measure of verbal fluency, which requires participants to generate words orally that begin with a given letter of the alphabet. Participants are given 1 min to name as many words as possible. Performance was calculated by the number of words generated in the 1-min period. This measure, requiring rapid and organized word retrieval, is a sensitive indicator of brain dysfunction.|Baseline and Week 96|The ITT analysis population included all participants who received at least 1 dose of study medication, satisfied all eligibility criteria and provided at least 1 post-baseline efficacy measurement. Here ‘N'=participants who were evaluated for this outcome measure.||Words generated per min||Standard Deviation|Mean
716475|NCT00269919|Secondary|Change From Baseline in Neurocognitive Function Test (NCFT): General Intelligence (Korean-Wechsler Adults Intelligence Scale [K-WAIS]) at Week 96|The K-WAIS is a Korean version of the Wechsler Adult Intelligence Scale-Revised (WAIS-R). It is an intelligence test that assess 3 general areas of intelligence quotients (IQ): verbal IQ, performance IQ and full-scale IQ (FSIQ). The verbal IQ includes: Digit Span, Vocabulary, and Arithmetic; performance IQ includes: Picture Arrangement and Block Design; and FSIQ is an IQ assessed by measuring an individual's overall level of general cognitive and intellectual functioning. The highest FSIQ is 160. The greater the quotient, higher the level of intelligence.|Baseline and Week 96|The ITT analysis population included all participants who received at least 1 dose of study medication, satisfied all eligibility criteria and provided at least 1 post-baseline efficacy measurement. Here ‘N'=participants who were evaluated for this outcome measure and ‘n'=participants who were evaluated for this outcome measure at given time point.||Intelligence quotient (IQ)||Standard Deviation|Mean
716476|NCT00269919|Secondary|Change From Baseline in World Health Organization (WHO)-Quality of Life (QOL) at Week 96|The WHOQOL-BREF is a 26-item, self-report questionnaire and short version of WHOQOL-100, consisting of 4 domains: physical health (7 items), psychological health (6 items), social relationships (3 items), and environmental health (8 items); it also contains QOL and general health items. Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life). The mean score of items within each domain is used to calculate the domain score. Each individual item of the WHOQOL-BREF is scored from 1=not at all to 5=completely on a response scale, which is stipulated as a 5-point ordinal scale. The scores are then transformed linearly to a scale of 0 (the worse quality of life) to 100 (the worse quality of life).|Baseline and Week 96|The ITT analysis population included all the participants who received at least 1 dose of study medication, satisfied all the eligibility criteria and provided at least 1 post-baseline efficacy measurement. Here, ‘N'=the participants who were evaluated for this outcome measure.||Units on a scale||Standard Deviation|Mean
716477|NCT00269919|Secondary|Change From Baseline in Global Assessment of Functioning (GAF) Score at Week 96|GAF is a 100-point tool rating overall psychological, social and occupational functioning of adults. The higher score range (91-100) refers to a superior functioning in a wide range of activities, and absence of symptoms. The lower score range (1-10) refers to persistent danger of severely hurting self or others; or persistent inability to maintain minimum personal hygiene; or serious suicidal act with clear expectation of death. Lower scores indicate worsening.|Baseline and Week 96|The ITT analysis population included all the participants who received at least 1 dose of study medication, satisfied all the eligibility criteria and provided at least 1 post-baseline efficacy measurement. Here, ‘N'=the participants who were evaluated for this outcome measure.||Units on a scale||Standard Deviation|Mean
716478|NCT00269919|Secondary|Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 96|The CGI-S rating scale is used to rate the severity of a participant's psychotic condition on a 7-point scale. It is rated as follows: 1=Normal, not at all ill, 2=Borderline mentally ill, 3=Mildly ill, 4=Moderately ill, 5=Markedly ill, 6=Severely ill, and 7=Among the most extremely ill. Higher scores indicate worsening.|Baseline and Week 96|The ITT analysis population included all the participants who received at least 1 dose of study medication, satisfied all the eligibility criteria and provided at least 1 post-baseline efficacy measurement. Here, ‘N'=the participants who were evaluated for this outcome measure.||Units on a scale||Standard Deviation|Mean
716479|NCT00269919|Primary|Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) Score at Week 96|The PANSS is a 30-item scale consisting of 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items) and it is designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 items are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 (absent) to 210 (extreme ill). Higher scores indicate worsening.|Baseline and Week 96|The intent-to-treat (ITT) analysis population included all the participants who received at least 1 dose of study medication, satisfied all the eligibility criteria and provided at least 1 efficacy measurement post-baseline. Here, ‘N'=the participants who were evaluated for this outcome measure.||Units on a scale||Standard Deviation|Mean
716480|NCT00270205|Secondary|Breadth of HIV-1-specific Immune Response, as Determined by the Number of Overlapping HIV-1 Peptides for Which the ELISPOT Assay for IFN-gamma Production is Observed to Have Five or More Spot-forming Cells/ 10^5 PBMCs|Results for this outcome will never be posted. Additional endpoint for supportive exploratory analysis, if ever the necessary assay is performed, will be defined in more detail in a separate analysis plan.|Throughout study||||||
716481|NCT00270205|Secondary|Lymphocyte Proliferation Stimulation Index (SI) in Response to Whole HIV-1 Antigen, p24 Antigen, and Pooled HIV-1 Peptide Antigens|Results for this outcome will never be posted. There is no plan to run the assay for this outcome measure.|Throughout study||||||
716482|NCT00270205|Secondary|Time-averaged AUC of T-cell Percent of HIV-1-specific CD8+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IL-2-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.||percent||Inter-Quartile Range|Median
716483|NCT00270205|Secondary|Time-averaged AUC of T-cell Count of HIV-1-specific CD8+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IL-2-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.||cells/mm^3||Inter-Quartile Range|Median
716544|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in Prolactin, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement||ng/mL||Full Range|Median
716484|NCT00270205|Secondary|Time-averaged AUC of T-cell Percent of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IL-2-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.||percent||Inter-Quartile Range|Median
716485|NCT00270205|Secondary|Time-averaged AUC of T-cell Count of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IL-2-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.||cells/mm^3||Inter-Quartile Range|Median
716486|NCT00270205|Secondary|Time-averaged AUC of T-cell Percent of HIV-1-specific CD8+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IFN-gamma-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.||percent||Inter-Quartile Range|Median
716487|NCT00270205|Secondary|Time-averaged AUC of T-cell Count of HIV-1-specific CD8+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IFN-gamma-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.||cells/mm^3||Inter-Quartile Range|Median
716488|NCT00270205|Secondary|Time-averaged AUC of T-cell Percent of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IFN-gamma-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.||percent||Inter-Quartile Range|Median
716489|NCT00270205|Secondary|Time-averaged AUC of T-cell Count of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IFN-gamma-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.||cells/mm^3||Inter-Quartile Range|Median
716490|NCT00270205|Secondary|Time-averaged AUC of T-cell Percent of HIV-1-specific CD8+ T-cell Subsets, Based on Flow Cytometry With CFSE Staining to Detect Antigen-specific Lymphocyte Proliferation Responding to Anti-CD3|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through week 24 were included in the analysis.||percent||Inter-Quartile Range|Median
716491|NCT00270205|Secondary|Time-averaged AUC of T-cell Percent of HIV-1-specific CD8+ T-cell Subsets, Based on Flow Cytometry With CFSE Staining to Detect Antigen-specific Lymphocyte Proliferation Responding to p24 Protein, Gag/Pol/Env, Tat/Rev and Whole HIV-1 Antigen.|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through week 24 were included in the analysis.||percent||Inter-Quartile Range|Median
716492|NCT00270205|Secondary|Time-averaged AUC of T-cell Count of HIV-1-specific CD8+ T-cell Subsets, Based on Flow Cytometry With CFSE Staining to Detect Antigen-specific Lymphocyte Proliferation Responding to Anti-CD3|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through week 24 were included in the analysis.||cells/mm^3||Inter-Quartile Range|Median
716493|NCT00270205|Secondary|Time-averaged AUC of T-cell Count of HIV-1-specific CD8+ T-cell Subsets, Based on Flow Cytometry With CFSE Staining to Detect Antigen-specific Lymphocyte Proliferation Responding to p24 Protein, Gag/Pol/Env, Tat/Rev and Whole HIV-1 Antigen.|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through week 24 were included in the analysis.||cells/mm^3||Inter-Quartile Range|Median
716494|NCT00270205|Secondary|Time-averaged AUC of T-cell Percent of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry With CFSE Staining to Detect Antigen-specific Lymphocyte Proliferation Responding to Anti-CD3|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.||percent||Inter-Quartile Range|Median
716495|NCT00270205|Secondary|Time-averaged AUC of T-cell Percent of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry With CFSE Staining to Detect Antigen-specific Lymphocyte Proliferation Responding to Whole HIV-1 Antigen|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.||percent||Inter-Quartile Range|Median
716496|NCT00270205|Secondary|Time-averaged AUC of T-cell Percent of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry With CFSE Staining to Detect Antigen-specific Lymphocyte Proliferation Responding to p24 Protein, Gag/Pol/Env and Tat/Rev.|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.||percent||Inter-Quartile Range|Median
716497|NCT00270205|Secondary|Time-averaged AUC of T-cell Count of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry With CFSE Staining to Detect Antigen-specific Lymphocyte Proliferation Responding to Anti-CD3|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks to anti-CD3 antigen were included in the analysis.||cells/mm^3||Inter-Quartile Range|Median
716498|NCT00270205|Secondary|Time-averaged AUC of T-cell Count of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry With CFSE Staining to Detect Antigen-specific Lymphocyte Proliferation Responding to Whole HIV-1 Antigen|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks to whole HIV-1 antigen were included in the analysis.||cells/mm^3||Inter-Quartile Range|Median
716499|NCT00270205|Secondary|Time-averaged AUC of T-cell Count of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry With CFSE Staining to Detect Antigen-specific Lymphocyte Proliferation Responding to p24 Protein, Gag/Pol/Env and Tat/Rev|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.||cells/mm3||Inter-Quartile Range|Median
716500|NCT00270205|Secondary|Anti-dsDNA Antibody Response|Results report the number of participants who had negative anti-dsDNA antibody result at baseline and at week 17 or 61.|From start of study vaccination to week 61|All participants who started study vaccination and who have anti-ds DNA results at baseline and week 17 or 61 were included in the analysis.||participants|||Number
716501|NCT00270205|Secondary|Time-averaged AUC of the Magnitude of HIV-specific Immune Response, as Determined by the Number of Spot-forming Cells/10^6 PBMCs Observed in Each ELISPOT Assay for IFN-gamma Production for Gag p17, Gag p24, Gag p15 and Tat/Rev.|Area under the curve (AUC) using linear trapezoidal method for each antigen was used to characterize each participant's overall response to the antigen. Each AUC was divided by 37 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 37|Only those participants who started study vaccination and who have complete and non-missing mean responses to gag-1, gag-2, gag-3 and tat/rev through 37 weeks were included in the analysis.||spot-forming cells/10^6 PBMC||Inter-Quartile Range|Median
716502|NCT00270205|Secondary|Time-averaged AUC of the Magnitude of HIV-specific Immune Response, as Determined by Taking the Mean of the Number of Spot-forming Cells/10^6 PBMCs Observed in Each ELISPOT Assay for IFN-gamma Production for Gag p17, Gag p24, Gag p15 and Tat/Rev.|At each week, the mean spot-forming cells/10^6 PBMCs across gag p17, gag p24, gag 15 and tat/rev was obtained per participant. Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 37 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 37|Only those participants who started study vaccination and who have complete and non-missing mean responses to gag-1, gag-2, gag-3 and tat/rev through 37 weeks were included in the analysis.||spot-forming cells/10^6 PBMC||Inter-Quartile Range|Median
716503|NCT00270205|Secondary|Time-averaged AUC of the Magnitude of HIV-specific Immune Response, as Determined by the Number of Spot-forming Cells/10^6 PBMCs Observed in Each PHPC Assay for IFN-gamma Production for Gag p17, Gag p24, Gag p15 and Tat/Rev.|Area under the curve (AUC) using linear trapezoidal method for each antigen was used to characterize each participant's overall response to the antigen as detected by the PHPC assay. Each AUC was divided by 37 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 37|Only those participants who started study vaccination and who have complete and non-missing mean responses to gag-1, gag-2, gag-3 and tat/rev through 37 weeks were included in the analysis.||spot-forming cells/10^6 PBMC||Inter-Quartile Range|Median
716504|NCT00270205|Secondary|Time-averaged AUC of the Magnitude of HIV-specific Immune Response, as Determined by Taking the Mean of the Number of Spot-forming Cells/10^6 PBMCs Observed in Each PHPC Assay for IFN-gamma Production for Gag p17, Gag p24, Gag p15 and Tat/Rev.|At each week, the mean spot-forming cells/10^6 PBMCs detected by the PHPC (precursors with high proliferative capacity) assay across gag p17, gag p24, gag p15 and tat/rev was obtained per participant. Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 37 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 37|Only those participants who started study vaccination and who have complete and non-missing mean responses to gag-1, gag-2, gag-3 and tat/rev through 37 weeks were included in the analysis.||spot-forming cells/10^6 PBMC||Inter-Quartile Range|Median
716545|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest and Lowest Value of Change in Platelet Count, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest/lowest value)|Phase 3 Safety Sample, participants with measurement||x10^9 c/L||Full Range|Median
716505|NCT00270205|Secondary|Time-averaged AUC of CD8+ T-cell Count in PBMCs|Area under the curve (AUC) using linear trapezoidal method, of CD8+ T-cell count responses was used to characterize each participant's overall CD8+ count response. Each AUC was divided by 61 weeks to have the same unit as the raw data.|From start of study vaccination to week 61|Only those participants who started study vaccination and who have complete and non-missing CD8+ T-cell count responses at all study visits were included in the analysis.||cells/mm^3||Inter-Quartile Range|Median
716506|NCT00270205|Secondary|Time-averaged Area Under the Curve (AUC) of CD4+ T-cell Count in PBMCs|Area under the curve (AUC) using linear trapezoidal method, of CD4+ T-cell count responses was used to characterize each participant's overall CD4+ count response. Each AUC was divided by 61 weeks to have the same unit as the raw data.|From start of study vaccination to week 61|Only those participants who started study vaccination and who have complete and non-missing CD4+ T-cell count responses at all study visits were included in the analysis.||cells/mm3||Inter-Quartile Range|Median
716507|NCT00270205|Primary|Percent of Participants With Primary Safety Endpoint|Primary safety endpoint is defined as occurrence of at least one grade 3 or higher adverse event, including signs/symptoms, lab toxicities, and/or clinical events that is possibly or definitely related to study treatment. Event's relationship to the study treatment was determined by the protocol core team, including site clinicians on the team, blinded to the treatment arm. Adverse events solely attributed to an allergic reaction to the adhesive of the tape used to adhere the vaccination patch to the skin and not the vaccine itself were not used in determination of the primary safety endpoint.|From start of study vaccination to 28 days after the last study vaccination|Only those participants who started study treatment/vaccination were included in the analysis.||percentage of participants||95% Confidence Interval|Number
716508|NCT00270231|Primary|Number of Nicotine Cigarette Choices Taken During the Cigarette Choice Procedure.|"On day 4 of each study medication period, participants completed a cigarette choice procedure where the subject is asked to take 4 puffs from a nicotinized (nicotine-containing) or a denicotinized (no nicotine) cigarette every 30 minutes for 2 hours (maximum of 24 puffs). The outcome variable is the number of nicotine cigarette choices or puffs out of 24 total puffs during these cigarette choice procedures.
Subjects who had the A/A genotype took an average of 18.5 puffs from the nicotine-containing cigarettes. Subjects with the A/G or G/G genotypes took an average of 16.2 puffs from the nicotine-containing cigarettes."|2 hours|Participants were analyzed with respect to genotype regardless of intervention.||Number of Nicotine Cigarette Puffs Taken||Standard Deviation|Mean
716509|NCT00255840|Primary|Cumulative Treatment Failure Rate of Participants on First Line Antiretroviral Therapy Monitored by Primary Health Care Nurses (Investigative Arm)is Not Inferior to the Cumulative Treatment Failure Rate of Participants Monitored by Doctors (Control Arm).|Cumulative treatment failure is a composite endpoint made up of death, virological failure, toxicity failure and protocol-defined loss to follow-up failure.|96 weeks|The primary analysis was an intention-to-treat analysis of any treatment failure with use of Cox proportional hazards regression.||Percentage of participants||95% Confidence Interval|Number
716510|NCT00255840|Secondary|To Estimate the Total and Incremental Costs, From the Provider and Societal Perspectives, of the Two Approaches (the Primary Health Care Sister and Doctor) to the Provision of Antiretrovirals in Primary Health Care Services in Each Study Site.||Throughout study||||||
716511|NCT00255840|Secondary|To Compare the Overall Clinical Safety of Antiretroviral Therapy, as Measured by the Occurrence of Clinical and Laboratory Grade 3 and 4 Adverse Events, Between Primary Health Care Monitoring Arms.||Throughout study||||||
716512|NCT00255840|Secondary|Drug Resistance HIV Mutations, Defined by Demonstration of Virologic Failure||Throughout the study||||||
716513|NCT00255840|Secondary|To Compare Subject Adherence to First Line Antiretroviral Treatment as Measured by Pill Count, Between the Two Primary Health Care Monitoring Models.||Throughout study||||||
716514|NCT00261443|Secondary|Extension Phase: Participants With Potentially Clinically Relevant ECG Abnormalities|ECG abnormalities considered by the investigator as clinically relevant.Left Bundle Branch Block: Not present at Baseline--> present post-baseline.|From first day until 30 days after the last dose of double-blind dosing in the Extension Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Participants in Extension Phase Safety Sample with ECG evaluation||Participants|||Number
716515|NCT00261443|Secondary|Extension Phase: Participants With Potentially Clinically Relevant Laboratory Abnormalities|Chemistry, hematology, and urinalysis abnormalities considered by the investigator as clinically relevant. Hematocrit: ≤37%(M)/≤32%(F)+3 percentage pts↓from baseline.|From first day until 30 days after the last dose of double-blind dosing in the Extension Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Participants in Extension Phase Safety Sample with laboratory evaluation||Participants|||Number
716516|NCT00261443|Secondary|Extension Phase: Adverse Events (AEs), by Maximum Intensity|AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. By Common Terminology Criteria Version 3.0 (CTC v3) Grade (Gr): Gr 1 (mild); Gr 2 (moderate); Gr 3 (severe); Gr 4 (life-threatening); Gr 5 (death).|From first day until 30 days after the last dose of double-blind dosing in the Extension Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Participants in Extension Phase Safety Sample with AEs||Participants|||Number
716517|NCT00261443|Secondary|Extension Phase: Participants With Potentially Clinically Relevant Vital Sign Abnormalities|Vital sign abnormalities considered by the investigator as clinically relevant.|From first day until 30 days after the last dose of double-blind dosing in the Extension Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Extension Phase Safety Sample||Participants|||Number
716518|NCT00261443|Secondary|Extension Phase: Participants With Potentially Clinically Relevant Metabolic Laboratory Abnormalities During Extension Phase|Metabolic abnormalities considered by the investigator as clinically relevant. (Need normal values for each.)|From first day until 30 days after the last dose of double-blind dosing in the Extension Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Number of Participants Analyzed=Participants in Extension Phase Safety Sample; n=number of participants with evaluation||Participants|||Number
716519|NCT00261443|Secondary|Extension Phase: Deaths, Adverse Events (AES), Serious Adverse Events (SAEs), and Discontinuations|Participants with Adverse Events (AEs), Deaths, Serious AEs (SAEs), and AEs leading to study discontinuation. AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|From first day until 30 days after the last dose of double-blind dosing in the Extension Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Extension Phase Safety Sample||Participants|||Number
716520|NCT00261443|Secondary|Extension Phase: Mean Change From Baseline in CGI-BP Severity of Illness (Overall) at Extension Phase Endpoint|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change in patients with bipolar disorder. Patients are rated on Change from Preceding Phase (mania, depression and overall bipolar illness) items (also a 7-point scale [1 to 7], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement.|Baseline, Extension Phase Endpoint. LTE Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|extension phase participants, last observation carried forward (LOCF)||units on a scale||Standard Error|Mean
716521|NCT00261443|Secondary|Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP Severity of Illness (Overall) Through Extension Phase|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change in patients with bipolar disorder. Patients are rated on Change from Preceding Phase (mania, depression and overall bipolar illness) items (also a 7-point scale [1 to 7], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement.|Baseline, Weeks 8, 16, 24, 32, 40, 48, 56, 64, 72. LTE Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Number of participants analyzed=extension phase participants, observed cases (OC) data set; n=number of participants evaluated at time point||units on a scale||Standard Error|Mean
716522|NCT00261443|Secondary|Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Through Extension Phase|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change in patients with bipolar disorder. Patients are rated on Change from Preceding Phase (mania, depression and overall bipolar illness) items (also a 7-point scale [1 to 7], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement.|Baseline, Weeks 8, 16, 24, 32, 40, 48, 56, 64, 72. LTE Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Number of participants analyzed=extension phase participants, observed cases (OC) data set; n=number of participants evaluated at time point||units on a scale||Standard Error|Mean
716523|NCT00261443|Secondary|Extension Phase: Mean Change From Baseline in CGI-BP Severity of Illness (Depression) at Extension Phase Endpoint|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change in patients with bipolar disorder. Patients are rated on Change from Preceding Phase (mania, depression and overall bipolar illness) items (also a 7-point scale [1 to 7], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement.|Baseline, Extension Phase Endpoint. LTE Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|extension phase participants, last observation carried forward (LOCF)||units on a scale||Standard Error|Mean
716524|NCT00261443|Secondary|Extension Phase: Mean Change From Baseline in CGI-BP (Mania) Severity of Illness at Extension Phase Endpoint|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change in patients with bipolar disorder. Patients are rated on Change from Preceding Phase (mania, depression and overall bipolar illness) items (also a 7-point scale [1 to 7], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement.|Baseline, Extension Phase Endpoint. LTE Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|extension phase participants, last observation carried forward (LOCF)||units on a scale||Standard Error|Mean
716525|NCT00261443|Secondary|Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP (Mania)|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change in patients with bipolar disorder. Patients are rated on Change from Preceding Phase (mania, depression and overall bipolar illness) items (also a 7-point scale [1 to 7], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement.|Baseline, Weeks 8, 16, 24, 32, 40, 48, 56, 64, 72 of LTE Phase. LTE Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Number of participants analyzed=extension phase participants, observed cases (OC) data set; n=number of participants evaluated at time point||units on a scale||Standard Error|Mean
716526|NCT00261443|Secondary|Number of Participants Taking Concomitant Medications for Potential Treatment of Extrapyramidal Syndrome (EPS) During Phase 3||Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Phase 3 Safety Sample||participants|||Number
716527|NCT00261443|Secondary|Adjusted Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment During Phase 3|The Barnes Akathisia Rating Scale is a 4-item scale to assess presence and severity of drug-induced akathisia, including both objective items and subjective items, together with a global clinical assessment of akathisia. Global assessment is made on a scale of 0 to 5 with comprehensive definitions provided for each anchor point on scale: 0=absent; 1=questionable; 2=mild akathisia; 3=moderate akathisia; 4=marked akathisia; 5=severe akathisia. Score has a possible range from 0 (absent) to 5 (severe akathisia). Negative change scores indicate improvement in akathisia.|Baseline, Weeks 4, 8, 12, 24, 36, 52, throughout Phase 3 (for Highest Value of Change)|Phase 3 Safety Sample, OC Data Set and Week 52 LOCF; n=number of participants with evaluation at time point||units on a scale||Standard Error|Mean
716546|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in Neutrophils (Relative), Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement||percent of total white blood cell count||Full Range|Median
716528|NCT00261443|Secondary|Adjusted Mean Change From Baseline in AIMS Item 10 During Phase 3|The AIMS is an assessment of movement dysfunctions. It is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs and 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in 3 main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe). AIMS Item 10 Score range from 0 to 4. A negative score signifies improvement.|Baseline, Weeks 4, 8, 12, 24, 36, 52, throughout Phase 3 (for Highest Value of Change)|Phase 3 Safety Sample, OC Data Set and Week 52 LOCF; n=number of participants with evaluation at time point||units on a scale||Standard Error|Mean
716529|NCT00261443|Secondary|Adjusted Mean Change From Baseline in AIMS Item 9 During Phase 3|The AIMS is an assessment of movement dysfunctions. It is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs and 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in 3 main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe). AIMS Item 9 Score range from 0 to 4. A negative score signifies improvement.|Baseline, Weeks 4, 8, 12, 24, 36, 52, throughout Phase 3 (for Highest Value of Change)|Phase 3 Safety Sample, OC Data Set and Week 52 LOCF; n=number of participants with evaluation at time point||units on a scale||Standard Error|Mean
716530|NCT00261443|Secondary|Adjusted Mean Change From Baseline in AIMS Item 8 During Phase 3|The AIMS is an assessment of movement dysfunctions. It is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs and 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in 3 main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe). AIMS Item 8 Score range from 0 to 4. A negative score signifies improvement.|Baseline, Weeks 4, 8, 12, 24, 36, 52, throughout Phase 3 (for Highest Value of Change)|Phase 3 Safety Sample, OC Data Set and Week 52 LOCF; n=number of participants with evaluation at time point||units on a scale||Standard Error|Mean
716531|NCT00261443|Secondary|Adjusted Mean Change From Baseline in AIMS Total Score During Phase 3|The AIMS is an assessment of movement dysfunctions. It is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs and 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in 3 main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe). The AIMS Total Score has a possible range from 0 to 28. Negative change scores indicate improvement in movement dysfunction.|Baseline, Weeks 4, 8, 12, 24, 36, 52, throughout Phase 3 (for Highest Value of Change)|Phase 3 Safety Sample, OC Data Set and Week 52 LOCF; n=number of participants with evaluation at time point||units on a scale||Standard Error|Mean
716532|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in Heart Rate, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement||bpm||Full Range|Median
716533|NCT00261443|Secondary|Adjusted Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score During Phase 3|The SAS is a 10-item instrument used to evaluate the presence and severity of parkinsonian symptomatology. It is the most commonly used rating scale for Parkinsonism in clinical trials over the past 25 years. The ten items focus on rigidity rather than bradykinesia, and do not assess subjective rigidity or slowness. Items are rated for severity on a 0-4 scale, with definitions given for each anchor point. The total SAS Score has a possible range from 10 to 50(lower scores=less severe). Negative change scores indicate improvement.|Baseline, Weeks 4,8, 12, 24, 36, 52, throughout Phase 3 (for Highest Value of Change)|Phase 3 Safety Sample, OC Data Set and Week 52 LOCF; n=number of participants with evaluation at time point||units on a scale||Standard Error|Mean
716534|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in QRS, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement||msecs||Full Range|Median
716535|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in RR, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement||msecs||Full Range|Median
716536|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in PR, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement||msecs||Full Range|Median
716537|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in QTc (0.33), Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement||msecs||Full Range|Median
716538|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in QT Interval Corrected for Heart Rate (QTc) Bazett, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement||msecs||Full Range|Median
716539|NCT00261443|Secondary|Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3|Sinus Tachycardia: ≥120bpm+↑≥15bpm+no current diagnosis of supraventricular (SV) or ventricular tachycardia or atrial fibrillation (AF) or flutter or other rhythm abnormality (RA). Sinus Bradycardia:≥50bpm+↓≥15bpm+no current diagnosis of AF or flutter or other RA. AF:not present→present or present at rate <100bpm pretreatment to present with rate ≥100bpm+increase of ≥15bpm. AV=atrioventricular; PR=PR interval. Other Intraventricular Block: QRS wave ≥0.12 sec+↑≥0.02 sec+no current diagnosis of left or right bundle branch block. Old Infarction not present→present at ≥12 weeks post study entry.|Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Phase 3 Safety Sample||Participants|||Number
716540|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest and Lowest Value of Change in Leukocytes, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest/lowest value)|Phase 3 Safety Sample, participants with measurement||x 10^3 c/uL||Full Range|Median
716541|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in Uric Acid, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement||mg/dL||Full Range|Median
716542|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in Triglycerides (Fasting), Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement||mg/dL||Full Range|Median
716549|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in HOMA2-IR, Phase 3 Safety Sample|HOMA stands for homeostasis model assessment of insulin resistance and beta-cell function. These are model-based calculations that use fasting insulin and glucose concentrations in order to assess pancreatic beta-cell function and insulin resistance. The HOMA2 model assesses insulin resistance (HOMA2-IR) relative to expected normal function (indexed to 1.0 for normal function) and is based on predictions from experimental human data on the relationship between insulin and glucose in a fasted state. HOMA2-IR is a proportion of ‘normal function.’|Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value|Phase 3 Safety Sample, participants with measurement||proportion of 'normal function'||Full Range|Median
716550|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in HOMA2-Percent Beta, Phase 3 Safety Sample|HOMA stands for homeostasis model assessment of insulin resistance and beta-cell function. These are model-based calculations that use fasting insulin and glucose concentrations in order to assess pancreatic beta-cell function and insulin resistance. The HOMA2 model assesses beta-cell function (HOMA2-%β) relative to expected normal function (indexed to 100% for normal function) and is based on predictions from experimental human data on the relationship between insulin and glucose in a fasted state. HOMA2-%Beta is a percentage of ‘normal function.’|Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value|Phase 3 Safety Sample, participants with measurement||percentage of 'normal function'||Full Range|Median
716551|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Lowest Value of Change in HDL Cholesterol (Fasting), Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for lowest value|Phase 3 Safety Sample, participants with measurement||mg/dL||Full Range|Median
716552|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Lowest Value of Change in Hematocrit, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for lowest value)|Phase 3 Safety Sample, participants with measurement||percentage of total blood volume||Full Range|Median
716553|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Lowest Value of Change in Hemoglobin, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for lowest value)|Phase 3 Safety Sample, participants with measurement||g/dL||Full Range|Median
716554|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in Glucose (Fasting), Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement||mg/dL||Full Range|Median
716555|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in Eosinophils (Relative), Phase 3 Safety Sample|The change values reported are the median of (post baseline percentage (of white blood cell count) minus baseline percentage (of white blood cell count).|Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement||percent of total white blood cell count||Full Range|Median
716556|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in Creatinine, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement||mg/dL||Full Range|Median
716557|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in Creatine Kinase, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement||U/L||Full Range|Median
716558|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in Total Cholesterol (Fasting), Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement||mg/dL||Full Range|Median
716559|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in BUN, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement||mg/dL||Full Range|Median
716560|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in AST, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement||U/L||Full Range|Median
716561|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in ALT, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement||U/L||Full Range|Median
716562|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in Alkaline Phosphatase (ALP), Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement||U/L||Full Range|Median
716563|NCT00261443|Secondary|Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3|ULN=upper limit of normal; Hb=hemoglobin|Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Phase 3 Safety Sample; n=number of participants with measurement||participants|||Number
716564|NCT00261443|Secondary|Median Baseline and Change From Baseline in Body Mass Index (BMI) During Phase 3||Baseline, Week 12, Week 24, Week 36, Week 52, Week 52 (LOCF), During Phase 3 (for lowest/highest values)|Phase 3 Safety Sample; n=number of participants with measurement at time point||kg/m^2||Inter-Quartile Range|Median
716565|NCT00261443|Secondary|Number of Participants Showing Relevant Weight Loss During Phase 3|Relevant weight loss: >=7% decrease from baseline|Weeks 12, 24, 36, 52, 52 (LOCF), and throughout Phase 3 (for 'at any time' assessment)|Phase 3 Safety Sample; n=number of participants with measurement at time point||Participants|||Number
716566|NCT00261443|Secondary|Number of Participants Showing Relevant Weight Gain During Phase 3|Relevant weight gain: >=7% increase from baseline|Weeks 12, 24, 36, 52, 52 (LOCF), and throughout Phase 3 (for 'at any time' assessment)|Phase 3 Safety Sample; n=number of participants with measurement at time point||Participants|||Number
716567|NCT00261443|Secondary|Baseline and Adjusted Mean Change From Baseline in Weight||Baseline, Weeks 12, 24, 36, 52, During Phase 3 (for highest value)|Observed Cases Data Set, Week 52 LOCF; n= number of participants with value at time point||kg||Standard Error|Mean
716568|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest and Lowest Values in Standing Heart Rate During Phase 3||Baseline, During Phase 3 (for highest/lowest values), Week 52|Participants in Phase 3 Safety Sample with measurement; Week 52 LOCF||beats per minute||Full Range|Median
716569|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest and Lowest Values in Standing Diastolic BP During Phase 3||Baseline, During Phase 3 (for highest/lowest values), Week 52|Participants in Phase 3 Safety Sample with measurement; Week 52 LOCF||mm Hg||Full Range|Median
716574|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest and Lowest Values in Supine Heart Rate During Phase 3||Baseline, During Phase 3 (for highest/lowest values), Week 52|Phase 3 Safety Sample, Week 52 Last Observation Carried Forward (LOCF)||beats per minute (bpm)||Full Range|Median
716575|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest and Lowest Values in Supine Diastolic BP During Phase 3||Baseline, During Phase 3 (for highest/lowest values), Week 52|Phase 3 Safety Sample, Week 52 Last Observation Carried Forward (LOCF)||mm Hg||Full Range|Median
716576|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest and Lowest Values in Supine Systolic BP During Phase 3||Baseline, During Phase 3 (for highest/lowest values), Week 52|Phase 3 Safety Sample, Week 52 Last Observation Carried Forward (LOCF)||mm Hg||Full Range|Median
716577|NCT00261443|Secondary|Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 3|Heart Rate: increase, ≥120 beats per minute (bpm) and ≥15 relative to baseline (RBL); decrease, ≤50 bpm and ≥15 RBL. Systolic BP: increase, ≥180 mmHg and ≥20 RBL; decrease, ≤90 mmHg and ≥20 RBL. Diastolic BP: increase, ≥105 mmHg and ≥15 RBL; decrease, ≤50 mmHg and ≥15 RBL. For patients missing a baseline value, an on-treatment value was considered potentially clinically relevant if the value meets the criterion value.|Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Phase 3 Safety Sample; n= number of participants with measurement||Participants|||Number
716578|NCT00261443|Secondary|Treatment-Emergent AEs in >=5% of Participants During Phase 3, by Age, Gender, Race, and Maximum Intensity|AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. By Common Terminology Criteria Version 3.0 (CTC v3) Grade (Gr): Gr 1 (mild); Gr 2 (moderate); Gr 3 (severe); Gr 4 (life-threatening); Gr 5 (death).|Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Phase 3 Safety Sample; (n=number of participants in sample for each category)||Participants|||Number
716579|NCT00261443|Secondary|Deaths, Treatment-Emergent Serious Adverse Events (SAEs), Adverse Events (AEs) in >=2% of Participants, and AEs Leading to Discontinuation During Phase 3|Participants with Adverse Events (AEs), Deaths, Serious AEs (SAEs), and AEs leading to study discontinuation. AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Phase 3 Safety Sample||Participants|||Number
716580|NCT00261443|Secondary|Unadjusted Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment at Phase 2 Endpoint|The Barnes Akathisia Rating Scale is a 4-item scale to assess presence and severity of drug-induced akathisia, including both objective items and subjective items, together with a global clinical assessment of akathisia. Global assessment is made on a scale of 0 to 5 with comprehensive definitions provided for each anchor point on scale: 0=absent; 1=questionable; 2=mild akathisia; 3=moderate akathisia; 4=marked akathisia; 5=severe akathisia. Score has a possible range from 0 (absent) to 5 (severe akathisia). Negative change scores indicate improvement in akathisia.|Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample, number of participants with evaluation at time point||units on a scale||Standard Error|Mean
716581|NCT00261443|Secondary|Baseline in Barnes Akathisia Global Clinical Assessment|The Barnes Akathisia Rating Scale is a 4-item scale to assess presence and severity of drug-induced akathisia, including both objective items and subjective items, together with a global clinical assessment of akathisia. Global assessment is made on a scale of 0 to 5 with comprehensive definitions provided for each anchor point on scale: 0=absent; 1=questionable; 2=mild akathisia; 3=moderate akathisia; 4=marked akathisia; 5=severe akathisia. Score has a possible range from 0 (absent) to 5 (severe akathisia). Negative change scores indicate improvement in akathisia.|Baseline|Phase 2 Safety Sample, number of participants with evaluation at time point||units on a scale||Standard Error|Mean
716582|NCT00261443|Secondary|Unadjusted Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score at Phase 2 Endpoint|The SAS is a 10-item instrument used to evaluate the presence and severity of parkinsonian symptomatology. It is the most commonly used rating scale for Parkinsonism in clinical trials over the past 25 years. The ten items focus on rigidity rather than bradykinesia, and do not assess subjective rigidity or slowness. Items are rated for severity on a 0-4 scale, with definitions given for each anchor point. The total SAS Score has a possible range from 10 to 50(lower score=less severe). Negative change scores indicate improvement.|Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample, number of participants with evaluation at time point||units on a scale||Standard Error|Mean
716583|NCT00261443|Secondary|Baseline in Simpson-Angus Scale (SAS) Total Score|The SAS is a 10-item instrument used to evaluate the presence and severity of parkinsonian symptomatology. It is the most commonly used rating scale for Parkinsonism in clinical trials over the past 25 years. The ten items focus on rigidity rather than bradykinesia, and do not assess subjective rigidity or slowness. Items are rated for severity on a 0-4 scale, with definitions given for each anchor point. The total SAS Score has a possible range from 10 to 50.(lower score=less severe). Negative change scores indicate improvement.|Baseline|Phase 2 Safety Sample, number of participants with evaluation at time point||units on a scale||Standard Error|Mean
716584|NCT00261443|Secondary|Unadjusted Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) at Phase 2 Endpoint|The AIMS is an assessment of movement dysfunctions. It is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs and 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in 3 main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe). The AIMS Total Score has a possible range from 0 to 28. Negative change scores indicate improvement in movement dysfunction.|Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample, participants with evaluation at time point||units on a scale||Standard Error|Mean
716585|NCT00261443|Secondary|Baseline Abnormal Involuntary Movement Scale (AIMS)|The AIMS is an assessment of movement dysfunctions. It is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs and 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in 3 main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe). The AIMS Total Score has a possible range from 0 to 28. Negative change scores indicate improvement in movement dysfunction.|Baseline|Phase 2 Safety Sample, participants with evaluation at time point||units on a scale||Standard Error|Mean
716586|NCT00261443|Secondary|Median Change From Baseline in Leukocytes at Phase 2 Endpoint||Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample, number of participants with evaluation at time point||x10^3 c/L||Full Range|Median
716587|NCT00261443|Secondary|Median Baseline Leukocytes||Baseline|Phase 2 Safety Sample, number of participants with evaluation at time point||x10^3 c/L||Full Range|Median
716588|NCT00261443|Secondary|Median Change From Baseline in Prolactin at Phase 2 Endpoint||Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample, number of participants with evaluation at time point||ng/dL||Full Range|Median
716589|NCT00261443|Secondary|Median Baseline Prolactin||Baseline|Phase 2 Safety Sample, number of participants with evaluation at time point||ng/dL||Full Range|Median
716590|NCT00261443|Secondary|Median Change From Baseline in Platelet Count at Phase 2 Endpoint||Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample, number of participants with evaluation at time point||x10^9 c/L||Full Range|Median
716591|NCT00261443|Secondary|Median Baseline Platelet Count||Baseline|Phase 2 Safety Sample, number of participants with evaluation at time point||x10^9 c/L||Full Range|Median
716592|NCT00261443|Secondary|Median Change From Baseline in HOMA2 Model Assesses Insulin Resistance (HOMA2-IR) at Phase 2 Endpoint|HOMA stands for homeostasis model assessment of insulin resistance and beta-cell function. These are model-based calculations that use fasting insulin and glucose concentrations in order to assess pancreatic beta-cell function and insulin resistance. The HOMA2 model assesses insulin resistance (HOMA2-IR) relative to expected normal function (indexed to 1.0 for normal function) and is based on predictions from experimental human data on the relationship between insulin and glucose in a fasted state. HOMA2-IR is a proportion of ‘normal function.’|Baseline (end of Ph 1), Phase 2 Endpoint (endpoint of a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample, number of participants with evaluation at time point||proportion of 'normal function'||Full Range|Median
716593|NCT00261443|Secondary|Median Change From Baseline in Homeostasis Model Assessment 2(HOMA2)-Percent Beta at Phase 2 Endpoint|HOMA stands for homeostasis model assessment of insulin resistance and beta-cell function. These are model-based calculations that use fasting insulin and glucose concentrations in order to assess pancreatic beta-cell function and insulin resistance. The HOMA2 model assesses beta-cell function (HOMA2-%β) relative to expected normal function (indexed to 100% for normal function) and is based on predictions from experimental human data on the relationship between insulin and glucose in a fasted state. HOMA2-%Beta is a percentage of ‘normal function.’|Baseline (end of Ph 1), Phase 2 Endpoint (endpoint of a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample, number of participants with evaluation at time point||percentage of 'normal function'||Full Range|Median
716594|NCT00261443|Secondary|Median Baseline Homeostasis Model Assessment 2 HOMA2-Insulin Resistance (IR)|HOMA stands for homeostasis model assessment of insulin resistance and beta-cell function. These are model-based calculations that use fasting insulin and glucose concentrations in order to assess pancreatic beta-cell function and insulin resistance. The HOMA2 model assesses insulin resistance (HOMA2-IR) relative to expected normal function (indexed to 1.0 for normal function) and is based on predictions from experimental human data on the relationship between insulin and glucose in a fasted state. HOMA2-IR is a proportion of ‘normal function.’|Baseline|Phase 2 Safety Sample, number of participants with evaluation at time point||proportion of 'normal function'||Full Range|Median
716595|NCT00261443|Secondary|Median Baseline Homeostasis Model Assessment 2 (HOMA2)-Percent Beta|HOMA stands for homeostasis model assessment of insulin resistance and beta-cell function. These are model-based calculations that use fasting insulin and glucose concentrations in order to assess pancreatic beta-cell function and insulin resistance. The HOMA2 model assesses beta-cell function (HOMA2-%β) relative to expected normal function (indexed to 100% for normal function) and is based on predictions from experimental human data on the relationship between insulin and glucose in a fasted state. HOMA2-%Beta is a percentage of ‘normal function.’|Baseline|Phase 2 Safety Sample, number of participants with evaluation at time point||percentage of 'normal function'||Full Range|Median
716596|NCT00261443|Secondary|Median Change From Baseline in Hematocrit||Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample, number of participants with evaluation at time point||percentage of total blood volume||Full Range|Median
716597|NCT00261443|Secondary|Median Baseline Hematocrit||Baseline|Phase 2 Safety Sample, number of participants with evaluation at time point||percentage of total blood volume||Full Range|Median
716598|NCT00261443|Secondary|Median Change From Baseline in Hemoglobin||Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample, number of participants with evaluation at time point||g/dL||Full Range|Median
716599|NCT00261443|Secondary|Median Baseline Hemoglobin||Baseline|Phase 2 Safety Sample, number of participants with evaluation at time point||g/dL||Full Range|Median
716600|NCT00261443|Secondary|Median Change From Baseline in Eosinophils (Relative) and Neutrophils (Relative)||Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample; n=number of participants with evaluation at time point||percent of total white blood cell count||Full Range|Median
716602|NCT00261443|Secondary|Median Change From Baseline in BUN, TC, Creatine, Glucose, HDL-C, LDL-C, Bilirubin-Total, Triglycerides, and Uric Acid at the End of Phase 2||Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample; n=number of participants with evaluation at time point||U/L||Full Range|Median
716603|NCT00261443|Secondary|Median Baseline Blood Urea Nitrogen (BUN), Total Cholesterol-Fasting (TC), Creatine, Glucose, High Density Lipoprotein Cholesterol-Fasting (HDL-C), Low Density Lipoprotein Cholesterol-Fasting (LDL-C), Bilirubin-Total, Triglycerides, and Uric Acid||Baseline|Phase 2 Safety Sample; n=number of participants with evaluation at time point||U/L||Full Range|Median
716604|NCT00261443|Secondary|Median Baseline and Change From Baseline in Heart Rate Measurements During Phase 2||Baseline (end of Ph 1), Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample; n= participants with measurement at time point.||msecs||Full Range|Median
716605|NCT00261443|Secondary|Median Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Lactate Dehydrogenase (LD) at the End of Phase 2||Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample; n=number of participants with evaluation at time point||U/L||Full Range|Median
716606|NCT00261443|Secondary|Median Baseline Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Lactate Dehydrogenase (LD), Phase 2 Safety Sample||Baseline|Phase 2 Safety Sample; n=number of participants with evaluation at time point||U/L||Full Range|Median
716607|NCT00261443|Secondary|Median Baseline and Change From Baseline in Body Mass Index (BMI) Vital Sign Measurements at Phase 2 Endpoint||Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample, participants with measurement at time point.||kg/m^2||Full Range|Median
716608|NCT00261443|Secondary|Median Baseline and Change From Baseline in Weight Vital Sign Measurements At Phase 2 Endpoint||Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample, participants with measurement at time point.||kg||Full Range|Median
716609|NCT00261443|Secondary|Median Baseline and Change From Baseline in Blood Pressure (BP) Vital Sign Measurements During Phase 2||Baseline (end of Ph 1), Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample; n= participants with measurement at time point.||mmHg||Full Range|Median
716610|NCT00261443|Secondary|Median Baseline and Change From Baseline in Heart Rate Vital Sign Measurements During Phase 2||Baseline (end of Ph 1), Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample; n= participants with measurement at time point.||beats per minute||Full Range|Median
716611|NCT00261443|Secondary|Median Baseline and Change From Baseline in ECG Measurements During Phase 2||Baseline (end of Ph 1), Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample; n= participants with measurement at time point.||msecs||Full Range|Median
716612|NCT00261443|Secondary|Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2|ULN=upper limit of normal; HDL=high density lipoprotein; LDL=low density lipoprotein. Values for ULN are provided by the lab in the database and could be different for each individual patient based on characteristics such as age, gender, or other patient attributes.|Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample; n=number of participants with evaluation at time point||Participants|||Number
716613|NCT00261443|Secondary|Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 2|Heart Rate: increase, ≥120 beats per minute (bpm) and ≥15 relative to baseline (RBL); decrease, ≤50 bpm and ≥15 RBL. Systolic BP: increase, ≥180 mmHg and ≥20 RBL; decrease, ≤90 mmHg and ≥20 RBL. Diastolic BP: increase, ≥105 mmHg and ≥15 RBL; decrease, ≤50 mmHg and ≥15 RBL. For patients missing a baseline value, an on-treatment value was considered potentially clinically relevant if the value meets the criterion value.|Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample||Participants|||Number
716614|NCT00261443|Secondary|Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2|Sinus Tachycardia: ≥120bpm+↑≥15bpm+no current diagnosis of supraventricular (SV) or ventricular tachycardia or atrial fibrillation (AF) or flutter or other rhythm abnormality (RA). Sinus Bradycardia:≥50bpm+↓≥15bpm+no current diagnosis of AF or flutter or other RA. AF:not present→present or present at rate <100bpm pretreatment to present with rate ≥100bpm+increase of ≥15bpm. AV=atrioventricular; PR=PR interval. Other Intraventricular Block: QRS wave ≥0.12 sec+↑≥0.02 sec+no current diagnosis of left or right bundle branch block. Old Infarction not present→present at ≥12 weeks post study entry.|Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample||Participants|||Number
716615|NCT00261443|Secondary|Treatment-Emergent Adverse Events in >=5 Percent of Participants, by Severity, During Phase 2|AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. By Common Terminology Criteria Version 3.0 (CTC v3) Grade (Gr): Gr 1 (mild); Gr 2 (moderate); Gr 3 (severe); Gr 4 (life-threatening); Gr 5 (death).|During Phase 2. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample||Participants|||Number
716862|NCT00262119|Secondary|Death for All Causes at 2 Years|Incidence, estimated via Kaplan Meier survival analysis, of death for any cause at 2 years|2 years|The analysis was intention to treat therefore all randomized patients were included in the analysis||percentage of participants||95% Confidence Interval|Number
716616|NCT00261443|Secondary|Deaths, Serious Adverse Events (SAEs), Adverse Events (AEs), and Discontinuations Due to AEs During Phase 2|Participants with Adverse Events (AEs), Deaths, Serious AEs (SAEs), and AEs leading to study discontinuation. AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|During Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample||Participants|||Number
716617|NCT00261443|Secondary|Proportion of Participants Discontinuing For Any Reason Through Week 52 (During Phase 3)||Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Randomized Sample||Proportion of Participants|||Number
716618|NCT00261443|Secondary|Number of Participants Maintaining Remission During Phase 3|Remission is defined as Y-MRS Total Score <=12 and MADRS Total Score <=12.|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52. Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Observed cases data set, Phase 3 Efficacy Sample||participants|||Number
716619|NCT00261443|Secondary|Adjusted Mean Change in CGI-BP From Preceding Phase (Overall) Through Phase 3|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change from baseline (in this case, preceding phase) in patients with bipolar disorder. Patients are rated on mania, depression and overall bipolar illness items on a 7-point scale [1 to 7], with 1 being very much improved and 7 being very much worse).|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52. Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|LOCF data set, phase 3 efficacy sample; 4 participants in the Week 4 placebo group were not evaluated.||units on a scale||Standard Error|Mean
716620|NCT00261443|Secondary|Unadjusted Mean Change From Preceding Phase in the CGI-BP (Overall) Through Phase 2|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change from baseline (in this case, preceding phase) in patients with bipolar disorder. Patients are rated on mania, depression and overall bipolar illness items on a 7-point scale [1 to 7], with 1 being very much improved and 7 being very much worse).|Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, and Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Observed Cases (OC) data set; phase 2 endpoint was phase 2 efficacy sample. n=number of participants with evaluation at time point||units on a scale||Standard Error|Mean
716621|NCT00261443|Secondary|Adjusted Mean Change in CGI-BP From Preceding Phase (Depression) Through Phase 3|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change from baseline (in this case, preceding phase) in patients with bipolar disorder. Patients are rated on mania, depression and overall bipolar illness items on a 7-point scale [1 to 7], with 1 being very much improved and 7 being very much worse).|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52. Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|LOCF data set, phase 3 efficacy sample; 4 participants in the Week 4 placebo group were not evaluated.||units on a scale||Standard Error|Mean
716622|NCT00261443|Secondary|Unadjusted Mean Change From Preceding Phase in the CGI-BP (Depression) Through Phase 2|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change in patients with bipolar disorder. Patients are rated on Change from Preceding Phase (mania, depression and overall bipolar illness) items (also a 7-point scale [1 to 7], with 1 being very much improved and 7 being very much worse).|Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, and Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Observed Cases (OC) data set; phase 2 endpoint was phase 2 efficacy sample. n=number of participants with evaluation at time point||units on a scale||Standard Error|Mean
716623|NCT00261443|Secondary|Adjusted Mean Change in CGI-BP From Preceding Phase (Mania) Through Phase 3|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change from baseline in patients with bipolar disorder. Patients are rated on mania, depression and overall bipolar illness items on a 7-point scale [1 to 7], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement.|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52. Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|LOCF data set, phase 3 efficacy sample; 4 participants in the Week 4 placebo group were not evaluated.||units on a scale||Standard Error|Mean
716624|NCT00261443|Secondary|Unadjusted Mean Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Mania) Through Phase 2|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change in patients with bipolar disorder. Patients are rated on Change from baseline (mania, depression and overall bipolar illness) items (also a 7-point scale [1 to 7], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement.|Baseline (end of Ph 1), Weeks 1, 2, 4,6, 8, 12, 16, 20, 24, and Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Observed Cases (OC) data set; phase 2 endpoint was phase 2 efficacy sample. n=number of participants with evaluation at time point||units on a scale||Standard Error|Mean
716625|NCT00261443|Secondary|Unadjusted Mean Change From Preceding Phase in the CGI-BP (Mania) Through Phase 2|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change from baseline in patients with bipolar disorder. Patients are rated on mania, depression and overall change from preceding phase items on a 7-point scale [1 to 7], with 1 being very much improved and 7 being very much worse).|Weeks 1, 2, 4,6, 8, 12, 16, 20, 24, and Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Observed Cases (OC) data set; phase 2 endpoint was phase 2 efficacy sample. n=number of participants with evaluation at time point||units on a scale||Standard Error|Mean
716863|NCT00262223|Secondary|Global Psychiatric Severity||1 year||||||
716864|NCT00262223|Secondary|Retention Rates in Alcohol Treatment||1 year||||||
716865|NCT00262223|Secondary|Trajectory and Trends of Changes in Substance Use and PTSD Symptoms||1 year||||||
716866|NCT00262223|Secondary|Alcohol Subtypes Based on Pre-morbid Risk Factors||1 year||||||
716626|NCT00261443|Secondary|Baseline and Adjusted Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Score Through Phase 3|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change from baseline in patients with bipolar disorder. Patients are rated on mania, depression and overall bipolar illness items on a 7-point scale [1 to 7], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement.|Baseline (end of Ph 2), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52. Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|LOCF data set, phase 3 efficacy sample; 4 participants in the Week 4 placebo group were not evaluated.||units on a scale||Standard Error|Mean
716627|NCT00261443|Secondary|Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Depression) Through Phase 2|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change in patients with bipolar disorder. Patients are rated on Change from baseline (mania, depression and overall bipolar illness) items (also a 7-point scale [1 to 7], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement.|Baseline (end of Ph 1), Weeks 1, 2, 4,6, 8, 12, 16, 20, 24, and Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Observed Cases (OC) data set; phase 2 endpoint was phase 2 efficacy sample. n=number of participants with evaluation at time point||units on a scale||Standard Error|Mean
716628|NCT00261443|Secondary|Baseline and Adjusted Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 3|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change from baseline in patients with bipolar disorder. Patients are rated on mania, depression and overall bipolar illness items on a 7-point scale [1 to 7], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement.|Baseline (end of Ph 2), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52. Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|LOCF data set, phase 3 efficacy sample; 4 participants in the Week 4 placebo group were not evaluated.||units on a scale||Standard Error|Mean
716629|NCT00261443|Secondary|Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 2|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change from baseline in patients with bipolar disorder. Patients are rated on mania, depression and overall bipolar illness items on a 7-point scale [1 to 7], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement.|Baseline (end of Ph 1), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, and Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Observed Cases (OC) data set; phase 2 endpoint was phase 2 efficacy sample. n=number of participants with evaluation at time point||units on a scale||Standard Error|Mean
716630|NCT00261443|Secondary|Mean Baseline and Adjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 3|The Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. MADRS total score, a 10-item, ordinal rating scale (0=no symptoms; 60=most severe symptoms). Change from baseline=postbaseline score - baseline score. A negative change score indicates improvement.|Baseline (end of Ph 2), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52. Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|LOCF data set, phase 3 efficacy sample; N=number of participants evaluated at time point; 4 participants in the Week 4 placebo group were not evaluated.||units on a scale||Standard Error|Mean
716631|NCT00261443|Secondary|Mean Baseline and Unadjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 2 and at Phase 2 Endpoint|The Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. MADRS total score, a 10-item, ordinal rating scale (0=no symptoms; 60=most severe symptoms). Change from baseline=postbaseline score - baseline score. A negative change score indicates improvement.|Baseline (end of Ph 1), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, and Phase 2 (Ph2) Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Observed Cases (OC) data set; phase 2 endpoint was phase 2 efficacy sample. n=number of participants with evaluation at time point||units on a scale||Standard Error|Mean
716632|NCT00261443|Secondary|Mean Baseline and Adjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 3|The Y-MRS consists of 11 items: 1) Elevated Mood, 2) Increased Motor Activity -Energy, 3) Sexual Interest, 4) Sleep, 5) Irritability, 6) Speech (Rate and Amount), 7) Language -Thought Disorder, 8) Content, 9) Disruptive-Aggressive Behavior, 10) Appearance, 11) Insight. 7 items are rated on a 0 to 4 scale, while 4 items (items 5, 6, 8 and 9) are rated on a 0 to 8 scale (twice the weight of the other items.) For all items, 0 is the “best” rating and 4 or 8 is the “worst” rating. Total Score is the sum of the ratings for all 11 items. The possible Total Scores are from 0 (best) to 60 (worst).|Baseline (end of Ph 2), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 of Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|LOCF data set, phase 3 efficacy sample; n=number of participants with measurement at time point||units on a scale||Standard Error|Mean
716633|NCT00261443|Secondary|Mean Baseline and Unadjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 2|"The Y-MRS consists of 11 items: 1) Elevated Mood, 2) Increased Motor Activity -Energy, 3) Sexual Interest, 4) Sleep, 5) Irritability, 6) Speech (Rate and Amount), 7) Language -Thought Disorder, 8) Content, 9) Disruptive-Aggressive Behavior, 10) Appearance, 11) Insight. Seven items are rated on a 0 to 4 scale, while 4 items (items 5, 6, 8 and 9) are rated on a 0 to 8 scale (twice the weight of the other items.) For all items, 0 is the best rating and 4 or 8 is the worst rating. Total Score is the sum of the ratings for all 11 items. The possible Total Scores are from 0 (best) to 60 (worst)."|Baseline (end of ph 1), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, and Phase 2 (Ph2) Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, + Confirmation of Partial Nonresponse Phase)|Observed Cases (OC) data set; n=number of participants with measurement at given time point.||units on a scale||Standard Error|Mean
716634|NCT00261443|Secondary|Proportion of Participants Not Experiencing Relapse of Depressive Episode Through Week 52 During Phase 3|Kaplan Meier estimated survival rate. Relapse is defined as any of the following events accompanied by a YMRS > 16 and/or a MADRS > 16; serious adverse event of worsening disease, or discontinuation by the investigator for lack of efficacy. A hospitalization for a manic, mixed, or depressive episode does meet the criteria for relapse, however does not require an accompanying Y-MRS and/or MADRS score > 16.|Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 of phase 3|Randomized sample, n=number of participants at risk at given time point||proportion of participants|||Number
716635|NCT00261443|Secondary|Proportion of Participants Not Experiencing Relapse of Manic Episode Through Phase 3|Kaplan-Meier estimated survival rate. Criteria for relapse include one or more of the following: relapse is defined as any of the following events accompanied by a Young-Mania Rating Scale (Y-MRS) >16 and/or a Montgomery Åsberg Depression Rating Scale (MADRS) >16; serious adverse event of worsening disease, or discontinuation by the investigator for lack of efficacy. A hospitalization for a manic, mixed, or depressive episode does meet the criteria for relapse, however does not require an accompanying Y-MRS and/or MADRS score >16.|Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 of phase 3|Randomized sample, n=number of participants at risk at given time point||proportion of participants|||Number
716636|NCT00261443|Secondary|Baseline and Adjusted Mean Change From Baseline in Clinical Global Impression Scale for Bipolar Disorder (CGI-BP) Severity of Illness Score (Mania) Through Phase 3|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change from baseline in patients with bipolar disorder. Patients are rated on mania, depression and overall bipolar illness items on a 7-point scale [1 to 7], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement.|Baseline (end of Phase 2), 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|LOCF data set, phase 3 efficacy sample; n=number of participants evaluated at given time point||units on a scale||Standard Error|Mean
716637|NCT00261443|Primary|Proportion of Participants Not Experiencing Relapse to Any Mood Episode Through Week 52, Phase 3|Kaplan-Meier estimated survival rate. Criteria for relapse include one or more of the following: hospitalization for a manic, mixed or depressive episode; serious adverse event of worsening disease under study accompanied by a Y-MRS > 16 and/or a MADRS > 16; discontinuation due to lack of efficacy as determined by the investigator accompanied by a Y-MRS > 16 and/or a MADRS > 16.|Week 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 of Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Randomized Sample; n=number of participants at risk at each time point||proportion of participants|||Number
716638|NCT00261495|Primary|Equi-analgesic Dose at Steady State (ITT Population)|Dose of OROS hydromorphone and SR oxycodone that induced the same pain control at steady state, defined as the mean dose from week 4 to week 24.|week 4 to week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||mg per day||Standard Deviation|Mean
716639|NCT00261495|Primary|Equi-analgesic Dose at Steady-state (PP Population)|Dose of OROS hydromorphone and SR oxycodone that induced the same pain control at steady state, defined as the mean dose from week 4 to week 24.|week 4 to week 24|PP population (all subjects who took the study medication at least once, who had post-baseline efficacy data, and who were without major protocol violation)||mg per day||Standard Deviation|Mean
716640|NCT00261495|Primary|Equi-analgesic Dosage of OROS Hydromorphone Once-daily and SR Oxycodone Twice-daily (ITT Population)|If non-inferiority of OROS hydromorphone was established, the daily dose of OROS hydromorphone and SR oxycodone that induced the same pain control was to be calculated (average dose used at week 24). Relative equi-analgesic dose was defined as mean dose/allowed maximum dose*100. Allowed maximum doses were 32mg OROS hydromorphone and 80mg SR oxycodone respectively.|week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||mg per day||Standard Deviation|Mean
716641|NCT00261495|Primary|Equi-analgesic Dosage of OROS Hydromorphone Once-daily and SR Oxycodone Twice-daily (PP Population)|If non-inferiority of OROS hydromorphone was established, the daily dose of OROS hydromorphone and SR oxycodone that induced the same pain control was to be calculated (average dose used at week 24). Relative equi-analgesic dose was defined as mean dose/allowed maximum dose*100. Allowed maximum doses were 32mg OROS hydromorphone and 80mg SR oxycodone respectively.|week 24|PP population (all subjects who took the study medication at least once, who had post-baseline efficacy data, and who were without major protocol violation)||mg per day||Standard Deviation|Mean
716642|NCT00261495|Secondary|Resource Utilization of Pain Management|Resource utilization was defined as the number of additional visits including additional telephone visits during the treatment period. This was assessed at week 24.|week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Additional visits||Standard Deviation|Mean
716643|NCT00261495|Secondary|Mode and Convenience of Drug Intake.|Subjects filled out a questionnaire based on the mode and convenience of drug intake and could rate their responses as very convenient, convenient, neither convenient or inconvenient, inconvenient, and very inconvenient.|weeks 4, 24, and 52|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Subjects|||Number
716644|NCT00261495|Secondary|Amount of add-on Pain Medication|Total amount of add-on pain medication (paracetamol) for the first 24 weeks was assessed at week 24.|24 weeks|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||mg||Standard Deviation|Mean
716645|NCT00261495|Secondary|Number of Days With add-on Pain Medication|Number of days with add-on pain medication during the first 24 weeks of the study was assessed at week 24.|week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Days||Standard Deviation|Mean
716646|NCT00261495|Secondary|Number of Drop-outs|Number of drop-outs according to reasons for drop-out and due to inefficacy at maximal dosage was assessed at weeks 24 and 52.|baseline to week 24 (core); week 24 to week 52 (extension)|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Subjects|||Number
716888|NCT00262522|Primary|Percentage of Subjects With Adverse Events of Diarrhea During the First 8 Weeks||Week 8|All randomized subjects who received at least 1 dose of study drug.||Percentage of Subjects|||Number
716647|NCT00261495|Secondary|Change in Dose of Study Treatment During Titration Phase (First 4 Weeks of Study) and Overall Treatment Phase I (First 24 Weeks of Study)|Number of subejcts with change in dose of study treatment was assessed and stratified by time on study, at least 4 weeks versus dropped out at highest dose before week 4, at weeks 4 and 24.|weeks 4 and 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Subjects|||Number
716648|NCT00261495|Secondary|Change in Dose of Study Treatment|Number of subjects with change in dose of study treatment was assessed at weeks 4, 24, and 52.|weeks 4, 24, and 52|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Subjects|||Number
716649|NCT00261495|Secondary|Clinical Global Assessment of Efficacy|Overall clinical efficacy was assessed by the Investigator using the following global ratings: very good, good, moderate, poor, or very poor, at weeks 4, 24, and 52.|weeks 4, 24, and 52|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Subjects|||Number
716650|NCT00261495|Secondary|Change From Baseline in QoL at Week 52|Change from baseline in QoL was assessed using the SF-36 QoL questionnaire at week 52. Scores could range from 0 to 100 with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in QoL.|baseline and week 52|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
716651|NCT00261495|Secondary|"Change From Baseline in QoL Vitality at Week 24"|Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 vitality score at week 24. Scores could range from 0 to 100 with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in vitality.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
716652|NCT00261495|Secondary|"Change From Baseline in QoL Social Functioning at Week 24"|Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 social functioning score at week 24. Scores could range from 0 to 100 with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in social functioning.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
716653|NCT00261495|Secondary|"Change From Baseline in QoL Role Physical at Week 24"|Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 role physical score at week 24. Scores could range from 0 to 100 with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in role physical.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
716654|NCT00261495|Secondary|"Change From Baseline in QoL Role Emotional at Week 24"|"Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 role emotional score at week 24. Scores could range from 0 to 100 with a higher score indicating a better QoL. Positive change from baseline scores indicate improvement in role emotional."|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
716655|NCT00261495|Secondary|"Change From Baseline in QoL Physical Functioning at Week 24"|Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 physical functioning score at week 24. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in physical functioning.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
716656|NCT00261495|Secondary|"Change From Baseline in QoL Mental Health at Week 24"|Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 mental health score at week 24. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline score indicates improvement in mental health.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
716657|NCT00261495|Secondary|"Change From Baseline in QoL Health Transition at Week 24"|Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 health transition score at week 24. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in health transition.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
716658|NCT00261495|Secondary|"Change From Baseline in QoL General Health Perceptions at Week 24"|Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 general health perceptions at week 24. Scores could range from 0 to 100 with a higher score indicating a better QoL. Positive change from baseline scores indicate improvement in health perceptions.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
716659|NCT00261495|Secondary|"Change From Baseline in QoL Bodily Pain at Week 24"|Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 bodily pain index score at week 24. Score could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in bodily pain.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
716660|NCT00261495|Secondary|"Change From Baseline in QoL Vitality at Week 4"|Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 vitality score at week 4. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in vitality.|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
716661|NCT00261495|Secondary|"Change From Baseline in QoL Social Functioning at Week 4"|Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 social functioning score at week 4. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in social functioning.|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
716662|NCT00261495|Secondary|"Change From Baseline in QoL Role Physical at Week 4"|Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 role physical score at week 4. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in role physical.|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
716663|NCT00261495|Secondary|"Change From Baseline in QoL Role Emotional at Week 4"|"Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 role emotional score at week 4. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in role emotional."|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
716664|NCT00261495|Secondary|"Change From Baseline in QoL Physical Functioning at Week 4"|Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 physical functioning score at week 4. Scores could range from 0 to 100, with high scores indicating a better QoL. Positive change from baseline scores indicate improvement in physical functioning.|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
716665|NCT00261495|Secondary|"Change From Baseline in QoL Mental Health at Week 4"|Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 mental health score at week 4. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in mental health score.|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
716666|NCT00261495|Secondary|"Change From Baseline in QoL Health Transition at Week 4"|Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 health transition score at week 4. Scores could range from 0 to 100, with higher scores indicating a better QoL. Positive change from baseline scores indicate improvement in health transition.|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
716667|NCT00261495|Secondary|"Change From Baseline in QoL General Health Perceptions at Week 4"|Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 general health perceptions score at week 4. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in general health perceptions.|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
716668|NCT00261495|Secondary|"Change From Baseline in Quality of Life (QoL) Bodily Pain at Week 4"|Change from baseline in QoL was assessed using the Short Form (SF)-36 QoL questionnaire, specifically the SF-36 bodily pain index. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in bodily pain.|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
716669|NCT00261495|Secondary|Number of Subjects With Dose Escalation at Week 24 (ITT Population)|The number of subjects with dose increase in study medication was assessed at week 24.|week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Subjects|||Number
716670|NCT00261495|Secondary|Number of Subjects With Dose Escalation at Week 4 (ITT Population)|The number of subjects with dose increase in study medication was assessed at week 4.|week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Subjects|||Number
716671|NCT00261495|Secondary|"Change From Baseline in Subject Diary Mean Pain Score for Pain at Its Worst From Morning to Evening at Weeks 4, 8, 12, 16, 20, and 24"|"Change from baseline in subject diary mean pain score pain at its worst from morning to evening at weeks 4, 8, 12, 16, 20, and 24. Subjects rated the severity of pain right now on a 10 point numeric scale, with 0 being the least pain and 10 being the most pain. Negative change from baseline scores indicate improvement in subject diary mean pain score pain at its worst."|baseline and weeks 4, 8, 12, 16, 20, and 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
716672|NCT00261495|Secondary|Change From Baseline in Subject Diary Mean Pain Evening, Morning, and All Day Scores at Week 24|Change from baseline to week 24 in subject diary evening, morning and all day mean pain scores for pain right now, at its worst, at its least, and average. Subjects rated the severity of pain on a 10 point numeric scale, with 0 being the least pain and 10 being the most pain. Negative change from baseline scores indicate improvement in subject diary mean pain scores.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
716673|NCT00261495|Secondary|Number of Subjects Indicating Optimal Sleep at Week 52|Number of subjects who experienced optimal sleep was assessed based on the number of hours of sleep reported on the MOS questionnaire at week 52. Optimal sleep was defined as 7-8 hours sleep per night.|week 52|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Subjects|||Number
716889|NCT00262600|Secondary|Abnormal Liver Function Test|Number of subjects with abnormal liver function test (LFT), i.e., ALT/AST>3xULN and total bilirubin > 2 x ULN|36 months|Safety set - all subjects who were randomized and received at least 1 dose of study drug||participants|||Number
716674|NCT00261495|Secondary|Change From Baseline in Sleep Quality at Week 52|Change from baseline in sleep quality was assessed using the MOS questionnaire at week 52. Score range 0 to 100. For disturbance, snoring, shortness of breath or headache, and somnolence, 0 = best sleep quality and 100 = worst sleep quality; negative change from baseline scores indicate improvement in sleep quality for these measures. For adequacy and quantity, 0 = worst sleep quality and 100 = best sleep quality; positive change from baseline scores indicate improvement in sleep quality for these measures.|baseline and week 52|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
716675|NCT00261495|Secondary|Number of Subjects Indicating That They Had Optimal Sleep at Week 24|Number of subjects indicating that they had optimal sleep was assessed based on the number of hours of sleep reported on the MOS questionnaire at week 24. Optimal sleep was defined as 7 to 8 hours sleep per night.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Subjects|||Number
716676|NCT00261495|Secondary|Change From Baseline in Sleep Quality, Sleep Quantity at Week 24|Change from baseline in sleep quality (sleep quantity) was assessed using the MOS questionnaire at week 24. Score range 0 to 100, where 0 = worst sleep quality and 100 = best sleep quality. Positive change from baseline scores indicate improvement in sleep quantity.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
716677|NCT00261495|Secondary|Change From Baseline in Sleep Quality, Sleep Somnolence at Week 24|Change from baseline in sleep quality (sleep somnolence) was assessed using the MOS questionnaire at week 24. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improvement in sleep somnolence.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
716678|NCT00261495|Secondary|Change From Baseline in Sleep Quality, Sleep Adequacy at Week 24|Change from baseline in sleep quality (sleep adequacy) was assessed using the MOS questionnaire at week 24. Score range 0 to 100, where 0 = worst sleep quality and 100 = best sleep quality. Positive change from baseline scores indicate improvement in sleep adequacy.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
716679|NCT00261495|Secondary|Change From Baseline in Sleep Quality, Sleep Shortness of Breath or Headache at Week 24|Change from baseline in sleep quality (sleep shortness of breath or headache) was assessed using the MOS questionnaire at week 24. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improvement in sleep shortness of breath or headache.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
716680|NCT00261495|Secondary|Change From Baseline in Sleep Quality, Snoring at Week 24|Change from baseline in sleep quality (snoring) was assessed using the MOS questionnaire at week 24. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improvement in snoring.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
716681|NCT00261495|Secondary|Change From Baseline in Sleep Quality, Sleep Disturbance at Week 24|Change from baseline in sleep quality (sleep disturbance) was assessed using the MOS questionnaire at week 24. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improvement in sleep disturbance.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
716682|NCT00261495|Secondary|Change From Baseline in Sleep Quality (MOS Index II) at Week 24|Change from baseline in sleep quality was assessed using the sleep subscales of the MOS questionnaire, which consists of 12 items. MOS index II (average of items 1, 3, 4, 5, 6, 7, 8, 9, and 12) was assessed at week 24. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improvement in sleep quality.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
716683|NCT00261495|Secondary|Change From Baseline in Sleep Quality (MOS Index II) at Week 4|Change from baseline in sleep quality was assessed using the sleep subscales of the MOS questionnaire, which consists of 12 items. MOS index II (average of items 1, 3, 4, 5, 6, 7, 8, 9, and 12) was assessed at week 4. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improvement in sleep quality.|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
716684|NCT00261495|Secondary|Change From Baseline in Sleep Quality (MOS Index I) at Week 4|Change from baseline in sleep quality was assessed using the sleep subscales of the MOS questionnaire, which consists of 12 items; MOS sleep scale index I (average of item 1, 3, 7, 8, 9, and 12) was assessed at week 4. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improvement in sleep quality.|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
716685|NCT00261495|Secondary|Change From Baseline in BPI Pain Severity, Relief and Interference Scores (Extension Phase)|Change from baseline in pain severity, pain relief, and pain interference was assessed using the BPI questionnaire at week 52. BPI items 3 to 6, score range 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine; BPI items 9a to 9g, score range from 0 to 10, where 0 = does not interfere and 10 = completely interferes. Negative change from baseline scores indicate improvement in pain severity and pain interference. BPI item 8, score range from 0 to 100, where 0 = no relief and 100 = complete relief. Positive change from baseline scores indicate improvement in pain relief.|baseline and week 52|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
716686|NCT00261495|Secondary|"Change From Baseline in Pain Interference Pain Interfered With Enjoyment of Life (BPI Item 9g) at Week 24"|"Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9g pain interfered with enjoyment of life at week 24. Scores could have ranged from 0 to 10, where 0 = does not interfere to 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with enjoyment of life."|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
716687|NCT00261495|Secondary|"Change From Baseline in Pain Interference Pain Interfered With Sleep (BPI Item 9f) at Week 24"|"Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9f pain interfered with sleep at week 24. Scores could have ranged from 0 to 10, where 0 = does not interfere to 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with sleep."|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
716688|NCT00261495|Secondary|"Change From Baseline in Pain Interference Pain Interfered With Relations With Other People (BPI Item 9e) at Week 24"|"Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9e pain interfered with relations with other people at week 24. Scores could have ranged from 0 to 10, where 0 = does not interfere to 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with relations with other people."|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
716689|NCT00261495|Secondary|"Change From Baseline in Pain Interference Pain Interfered With Normal Work (BPI Item 9d) at Week 24"|"Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9d pain interfered with normal work at week 24. Scores could have ranged from 0 to 10, where 0 = does not interfere to 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with normal work."|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
716690|NCT00261495|Secondary|"Change From Baseline in Pain Interference Pain Interfered With Walking Ability (BPI Item 9c) at Week 24"|"Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9c pain interfered with walking ability at week 24. Scores could have ranged from 0 to 10, where 0 = does not interfere to 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with walking ability."|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
716691|NCT00261495|Secondary|"Change From Baseline in Pain Interference Pain Interfered With Mood (BPI Item 9b) at Week 24"|"Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9b pain interfered with mood at week 24. Scores could have ranged from 0 to 10, where 0 = does not interfere to 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with mood."|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
716692|NCT00261495|Secondary|"Change From Baseline in Pain Interference Pain Interfered With General Activity (BPI Item 9a) at Week 24"|"Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9a pain interfered with general activity at week 24. Scores could have ranged from 0 to 10, where 0 = does not interfere to 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with general activity."|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
716693|NCT00261495|Secondary|"Change From Baseline in Pain Interference Pain Interfered With Enjoyment of Life (BPI Item 9g) at Week 4"|"Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9g pain interfered with enjoyment of life at week 4. Scores could have ranged from 0 to 10, where 0 = does not interfere and 10 = interferes completely. Negative change from baseline scores indicate improvement in pain interfered with enjoyment of life."|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
716694|NCT00261495|Secondary|"Change From Baseline in Pain Interference Pain Interfered With Sleep (BPI Item 9f) at Week 4"|"Change from baseline in pain interference was assessed using BPI questionnaire, specifically BPI item 9f pain interfered with sleep at week 4. Scores could have ranged from 0 to 10, where 0 = does not interfere and 10 - completely interferes. Negative change from baseline scores indicate improvement in pain interfered with sleep."|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
716695|NCT00261495|Secondary|"Change From Baseline in Pain Interference Pain Interfered With Relations With Other People (BPI Item 9e) at Week 4"|"Change from baseline in pain interference was assessed using BPI questionnaire, specifically BPI item 9e pain interfered with relations with other people at week 4. Scores could have ranged from 0 to 10, where 0 = does not interfere and 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with relations with other people."|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
716696|NCT00261495|Secondary|"Change From Baseline in Pain Interference Pain Interfered With Normal Work (BPI Item 9d) at Week 4"|"Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9d pain interfered with normal work at week 4. Scores could have ranged from 0 to 10, where 0 = does not interfere and 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with normal work."|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
716697|NCT00261495|Secondary|"Change From Baseline in Pain Interference Pain Interfered With Walking Ability (BPI Item 9c) at Week 4"|"Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9c pain interfered with walking ability at week 4. Scores could have ranged from 0 to 10, where 0 = does not interfere and 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with walking ability."|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
716698|NCT00261495|Secondary|"Change From Baseline in Pain Interference Pain Interfered With Mood (BPI Item 9b) at Week 4"|"Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9b pain interfered with mood at week 4. Scores could have ranged from 0 to 10, where 0 = does not interfere and 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with mood."|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
716699|NCT00261495|Secondary|"Change From Baseline in BPI Interference Score Interfered With General Activity (BPI Item 9a) at Week 4"|"Change from baseline in interference of pain was assessed using the BPI questionnaire, specifically BPI item 9a pain interfered with general activity at week 4. Scores could have ranged from 0 to 10, where 0 = does not interfere and 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with general activity."|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
716700|NCT00261495|Secondary|Change From Baseline in BPI Pain Severity Score (Mean of BPI Items 3 to 6) at Week 24|Change in pain severity was assessed using the BPI questionnaire, specifically average (mean) score of BPI items 3 to 6 (worst pain, least pain, average pain, and pain right now) at week 24. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative scores indicate improvement in pain severity.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
716701|NCT00261495|Secondary|Change From Baseline in BPI Pain Relief Score (BPI Item 8) at Week 24|Change from baseline in pain severity was assessed using the BPI questionnaire, specifically pain relief (BPI item 8) at week 24. Scores could have ranged from 0 to 100, where 0 = no relief and 100 = complete relief. Positive change from baseline scores indicate improvement in pain relief.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
716702|NCT00261495|Secondary|"Change From Baseline in BPI Pain Severity Average Pain (BPI Item 5) at Week 24"|"Change from baseline in pain severity was assessed using the BPI questionnaire, specifically average pain (BPI item 5) at week 24. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in average pain."|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
716703|NCT00261495|Secondary|"Change From Baseline in BPI Pain Severity Pain at Its Least (BPI Item 4) at Week 24"|"Change from baseline in pain severity was assessed using the BPI questionnaire, specifically pain at its least (BPI item 4) at week 24. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in pain at its least."|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
716704|NCT00261495|Secondary|Change From Baseline in BPI Pain Severity Score (Mean of BPI Items 3 to 6) at Week 4|Change from baseline in BPI pain severity was assessed using the BPI questionnaire (mean of BPI items 3 to 6) at week 4. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in pain severity.|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
716705|NCT00261495|Secondary|Change From Baseline in BPI Pain Relief Score (BPI Item 8) at Week 4|Change from baseline in pain severity was assessed using the BPI questionnaire, specifically pain relief (BPI item 8) at week 4. Scores could have ranged from 0 to 100, where 0 = no relief and 100 = complete relief. Positive change from baseline scores indicate improvement in pain relief.|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
716706|NCT00261495|Secondary|"Change From Baseline in BPI Pain Severity Average Pain (BPI Item 5) at Week 4"|"Change from baseline in pain severity was assessed using the BPI questionnaire, specifically average pain (BPI item 5) at week 4. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in average pain."|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
716707|NCT00261495|Secondary|"Change From Baseline in BPI Pain Severity Pain at Its Worst (BPI Item 3) at Week 4"|"Change from baseline in pain severity was assessed using the BPI questionnaire, specifically pain at its worst (BPI item 3) at week 4. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in pain at its worst."|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
716708|NCT00261495|Secondary|"Change From Baseline in BPI Pain Severity Score Pain at Its Least (BPI Item 4) at Week 4"|"Change from baseline in pain severity was assessed using the BPI questionnaire, specifically pain at its least (BPI item 4) at week 4. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in pain at its least."|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
716709|NCT00261495|Secondary|"Change From Baseline in BPI Severity Score Pain Right Now (BPI Item 6) at Week 4"|"Change from baseline in pain severity was assessed using the BPI questionnaire, specifically pain right now (BPI item 6) at week 4. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in pain right now."|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
716710|NCT00261495|Secondary|Number of Subjects With Dose Escalation|Number of subjects with dose increase in study medication.|week 4 and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Subjects|||Number
716711|NCT00261495|Secondary|"Change From Baseline in Subject Diary Morning Mean Pain Score Pain Right Now at Week 24"|"Change from baseline to week 24 in subject diary morning mean pain score pain right now. Subjects rated the severity of pain right now on a 10 point numeric scale, with 0 being the least pain and 10 being the most pain. Negative change from baseline scores indicate improvement in subject diary evening mean pain score pain right now."|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
716712|NCT00261495|Secondary|"Change From Baseline in Subject Diary Evening Mean Pain Score Pain Right Now at Week 24"|"Change from baseline to week 24 in subject diary evening mean pain score pain right now. Subjects rated the severity of pain right now on a 10 point numeric scale, with 0 being the least pain and 10 being the most pain. Negative change from baseline scores indicate improvement in subject diary evening mean pain score pain right now."|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
716713|NCT00261495|Secondary|Change From Baseline in Sleep Quality at Week 24|Change from baseline in sleep quality was assessed using the Medical Outcomes Study (MOS) questionnaire at week 24, specifically the sleep subscale index I. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improved sleep quality.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
716714|NCT00261495|Primary|"Change From Baseline in BPI Questionnaire Item 6 Pain Right Now Score at Week 24 (Intent to Treat [ITT] Population)"|"Assessment of non-inferiority of OROS hydromorphone compared with SR oxycodone with regard to pain control by measuring the change from baseline in pain severity, using BPI item 6 pain right now score at week 24. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in pain right now."|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
716715|NCT00261495|Secondary|"Change From Baseline in BPI Pain Severity Sub-score Pain at Its Worst (BPI Item 3) at Week 24 (ITT Population)"|"Change from baseline to week 24 in BPI pain severity, pain at its worst (BPI item 3) assessed using the BPI questionnaire. Score values ranges from 0 (no pain) to 10 (pain as bad as you can imagine). Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in pain at its worst."|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
716716|NCT00261495|Primary|"Change From Baseline in Brief Pain Inventory (BPI) Questionnaire Item 6 Pain Right Now Score at Week 24 (Per Protocol [PP] Population)"|"Assessment of non-inferiority of OROS hydromorphone compared with sustained release (SR) oxycodone with regard to pain control by measuring the change from baseline in pain severity, using BPI item 6 pain right now score at week 24. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in pain right now."|baseline and week 24|PP population (all randomized subjects who took the study medication at least once, who had post-baseline efficacy data, and who were without major protocol violation)||Units on a scale||Standard Deviation|Mean
716717|NCT00261716|Secondary|Association Between Employment Status and Overall Adjustment as Rated on the Social Adjustment Scale II (Schooler)|Employment status at each major follow-up assessment period and overall adjustment as rated on the Social Adjustment Scale II (Schooler, N., G. Hogarty, and M. Weissman, Social Adjustment Scale II (SAS-II), in Resource Materials for Community Mental Health Program Evaluations, W.A. Hargreaves, C.C. Atkisson, and J.E. Sorenson, Editors. 1979, NIMH: Rockville, MD. p. 290-303), on a 1 (excellent adjustment ) to 7 (severe maladjustment) scale.|6, 12, and 18 months|Number of individuals working within one month of assessment point varies by follow up point; total n=38 at baseline; total n=25 analyzed at 6 months; total n= 16 analyzed at 12 months; total n = 17 analyzed at 18 months||units on a scale||Standard Deviation|Mean
716718|NCT00261716|Secondary|Association Between Employment Status and Self-reported Life Satisfaction Measured on the Quality of Life Scale (Lehman)|Employment status at each major follow-up assessment period and self-reported Life Satisfaction (range from 1 (terrible) to 7 (delighted)) on the Quality of Life Scale (Lehman A, Kernan E, and Postrado L, Toolkit for Evaluating Quality of Life for Persons with Severe Mental Illness. 1995, Baltimore, MD: The Evaluation Center at HSRI).|6,12, 18 months|Number of individuals working within one month of assessment point varies by follow up point; total n=38 at baseline; total n=26 analyzed at 6 months; total n= 19 analyzed at 12 months; total n = 17 analyzed at 18 months||units on a scale||Standard Deviation|Mean
716719|NCT00261716|Secondary|Association Between Employment Status and Psychiatric Symptoms as Measured on the Brief Psychiatric Rating Scale|Employment status at each major follow-up assessment period and psychiatric symptomatology as reflected in the Total Brief Psychiatric Rating Scale Score (Ventura J, et al., Training and quality assurance with the Structured Clinical Interview for DSM-IV (SCID-I/P). Psychiatry Research, 1998. 79(2): p. 163-173) with scale range from 24 to 168, with higher scores indicating greater symptomatology|6,12, 18 months|Number of individuals working within one month of assessment point varies by follow up point; total n=38 at baseline; total n=23 analyzed at 6 months; total n= 19 analyzed at 12 months; total n = 16 analyzed at 18 months||units on a scale||Standard Deviation|Mean
716720|NCT00261716|Secondary|Obtained a Second Job if Lost First Job and Still Had at Least 2 Months in the Program|Number of participants who obtained a second or third job if lost his/her first job but still had at least 2 months in the study|18 months of the study|Includes only participants who obtained at least one job and had at least 2 months left if they lost/left that job; 2 individuals in each condition held the same job for almost the whole program and thus could not contribute data here||participants|||Number
716721|NCT00261716|Primary|Average Number of Hours Worked Per Week For Those Who Worked|Average number of hours worked per week among participants who obtained a job|18 months of study|Only included hours worked for participants who obtained a job (n=19 in the entire study)||hours/worked per week||Standard Deviation|Mean
716722|NCT00261716|Primary|Average Number of Days Worked|Average number of total days each participant worked in the study|18 months of study|||days||Standard Deviation|Mean
716723|NCT00261716|Primary|Obtained Employment|Number of participants who obtained a competitive job|18 months of study|||participants|||Number
716724|NCT00261833|Other Pre-specified|Baseline Lung Density at Total Lung Capacity (TLC) and Forced Residual Capacity (FRC)||Baseline|||g/L||Standard Deviation|Mean
716725|NCT00261833|Secondary|Severity of Pulmonary Exacerbations|"Defined as the number of participants requiring 1) antibiotic treatment for exacerbations, and 2) hospitalization for exacerbations. Primary diagnostic criteria for exacerbations were increased dyspnea, increased sputum volume, and increased sputum purulence. Supporting diagnostic criteria were upper respiratory tract infection, fever without other apparent cause, increased wheezing, and increased cough. For diagnosis, participants had to meet 2 of the 3 primary criteria or 1 primary criterion and 1 supporting criterion.
Antibiotic treatment usage was reported by quarterly interval."|Over a 2-year period|All participants with A1-PI deficiency who were included in the study and randomized.||participants|||Number
716726|NCT00261833|Secondary|Duration of Pulmonary Exacerbations Relative to Treatment Duration|Defined as the percentage of total treatment duration across participants for 1) exacerbations overall, 2) antibiotic treatment for exacerbations, and 3) hospitalization for exacerbations. Primary diagnostic criteria for exacerbations were increased dyspnea, increased sputum volume, and increased sputum purulence. Supporting diagnostic criteria were upper respiratory tract infection, fever without other apparent cause, increased wheezing, and increased cough. For diagnosis, participants had to meet 2 of the 3 primary criteria or 1 primary criterion and 1 supporting criterion.|Over a 2-year period|All participants with A1-PI deficiency who were included in the study and randomized.||percentage of total treatment duration||Standard Deviation|Mean
716727|NCT00261833|Secondary|Percent Change in DLCO|Percent change from baseline to Month 24.|From baseline to 2 years|All participants with A1-PI deficiency who were included in the study, randomized, and had a baseline and at least one endpoint assessment available.||percent change||Standard Error|Least Squares Mean
716728|NCT00261833|Secondary|Percent Change in FEV1 Divided by Forced Vital Capacity|Percent change from baseline to Month 24.|From baseline to 2 years|All participants with A1-PI deficiency who were included in the study, randomized, and had a baseline and at least one endpoint assessment available.||percent change||Standard Error|Least Squares Mean
716729|NCT00261833|Secondary|Percent Change in Percent Predicted FEV1|Percent change from baseline to Month 24.|From baseline to 2 years|All participants with A1-PI deficiency who were included in the study, randomized, and had a baseline and at least one endpoint assessment available.||percent change||Standard Error|Least Squares Mean
716730|NCT00261833|Secondary|Frequency and Intensity of Adverse Events (AEs)|Number of participants with at least one AE, and the number of participants with mild, moderate or severe AEs. AE intensity was defined as mild (does not interfere with routine activities), moderate (interferes with routine activities), or severe (impossible to perform routine activities).|Over a 2-year period|All participants receiving at least 1 infusion of either Zemaira® or placebo.||participants|||Number
716731|NCT00261833|Secondary|Change in Patient-reported Symptoms|Patient-reported symptoms were measured using the symptoms score component of the St George's Respiratory Questionnaire (SGRQ). SGRQ scores range from 0 to 100, with higher scores indicating more limitations and negative values for change indicating improvement. Change from baseline to end of treatment (2 years) in SGRQ was analysed using an ANCOVA.|From baseline to 2 years|All participants with A1-PI deficiency who were included in the study, randomized, and had a baseline and at least one endpoint assessment available.||units on a scale||Standard Error|Least Squares Mean
716732|NCT00261833|Secondary|Change in Exercise Capacity|Exercise capacity was measured as distance walked, using the incremental shuttle walk test. Change from baseline to end of treatment (2 years) in exercise capacity was analysed using an analysis of covariance (ANCOVA).|From baseline to 2 years|All participants with A1-PI deficiency who were included in the study, randomized, and had a baseline and at least one endpoint assessment available.||metre||Standard Error|Least Squares Mean
716733|NCT00261833|Secondary|Change in Lung Density|Change from baseline to Month 24 as measured by centralized, standardized CT lung densitometry. CT scans were acquired at 2 inspiration states: TLC (ie, full inspiration) and FRC (ie, full expiration). Results were adjusted for total lung volume.|From baseline to 2 years|All participants with A1-PI deficiency who were included in the study, randomized, and had a baseline and at least 1 endpoint assessment available.||g/L||Standard Error|Least Squares Mean
716734|NCT00261833|Secondary|Time to First Pulmonary Exacerbation|Primary diagnostic criteria for exacerbations were increased dyspnea, increased sputum volume, and increased sputum purulence. Supporting diagnostic criteria were upper respiratory tract infection, fever without other apparent cause, increased wheezing, and increased cough. For diagnosis, participants had to meet 2 of the 3 primary criteria or 1 primary criterion and 1 supporting criterion.|Over a 2-year period|All participants with A1-PI deficiency who were included in the study and randomized.||Years||95% Confidence Interval|Median
716735|NCT00261833|Secondary|Percent Change in FEV1|Percent change from baseline to Month 24.|From baseline to 2 years|All participants with A1-PI deficiency who were included in the study, randomized, and had a baseline and at least one endpoint assessment available.||percent change||Standard Error|Least Squares Mean
716773|NCT00261846|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC(0-48)] - Part 1|AUC(0-48)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-48).|0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1|Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment.||ng*hr/mL||Standard Deviation|Mean
716736|NCT00261833|Secondary|Annual Rate of Pulmonary Exacerbations|Primary diagnostic criteria for exacerbations were increased dyspnea, increased sputum volume, and increased sputum purulence. Supporting diagnostic criteria were upper respiratory tract infection, fever without other apparent cause, increased wheezing, and increased cough. For diagnosis, participants had to meet 2 of the 3 primary criteria or 1 primary criterion and 1 supporting criterion. The annual rate was based on the total number of exacerbations and the total number of participant study days for all participants in the specified analysis population and adjusted to 365.25 days.|Over a 2-year period|All participants with A1-PI deficiency who were included in the study and randomized.||exacerbations per participant year||95% Confidence Interval|Number
716737|NCT00261833|Primary|Annual Rate of Change in Lung Density|As measured by centralized, standardized computer tomographic (CT) lung densitometry. CT scans were acquired at 2 inspiration states: TLC (ie, full inspiration) and FRC (ie, full expiration). Results were adjusted for total lung volume and are presented as point estimates for the average rate of decline in each treatment group.|Over a 2-year period|All randomized participants with at least 1 valid CT scan.||g/L per year||Standard Error|Least Squares Mean
716738|NCT00261846|Secondary|Percentage of Participants With Change From Baseline in Physical Examinations and Vital Signs and Number of Participants With PCI Values|Percentage of participants with PCI physical examinations and vital signs is reported during therapy and at post therapy. Criteria for PCI change in vital signs: heart rate value of <40 beats per min and value >150 beats per min, SBP of <80 or >210 mmHg, DBP of <40 or >130 mmHg, temperature <32 or >40 degree centigrade, Resp of <10 or >50 breaths/min and criteria for PCI change in physical examination: >=10% increase or decrease of body weight in kg. No Ph+ ALL participants were analyzed post-therapy (N=0). Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.|Post-therapy|Safety population included all participants who receive at least one dose of study medication. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this measure. PLEASE NOTE: Results were not applicable for Arms in Part 1 since all participants in Part 1 entered Part 2 and continued the study treatment.||percentage of participants|||Number
716739|NCT00261846|Secondary|Percentage of Participants With Change From Baseline in Physical Examinations and Vital Signs|Percentage of participants with PCI physical examinations and vital signs is reported during therapy and at post therapy. Criteria for PCI change in vital signs: heart rate value of <40 beats per min and value >150 beats per min, systolic blood pressure (SBP) of <80 or >210 millimeter of mercury (mmHg), diastolic blood pressure (DBP) of <40 or >130 mmHg, temperature <32 or >40 degree centigrade, respiratory rate (Resp) of <10 or >50 breaths/min and criteria for PCI change in physical examination: >=10% increase or decrease of body weight in kilogram (kg).|Screening, Baseline, and end of treatment|Safety population included all participants who receive at least one dose of study medication. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this measure.||percentage of participants|||Number
716740|NCT00261846|Secondary|Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)|ECOG-PS measured on-therapy (time between first dose and last dose date with a 30-day lag) assessed participant's performance status on 5 point scale: 0=Fully active/able to carry on all pre-disease activities without restriction;1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work;2=ambulatory (>50% of waking hrs), capable of all self care, unable to carry out any work activities;3=capable of only limited self care, confined to bed/chair >50% of waking hrs;4=completely disabled, cannot carry on any self care, totally confined to bed/chair;5=dead.|Baseline, Week 1, 2, 8, 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks thereafter|Safety population included all participants who receive at least one dose of study medication.||participants|||Number
716741|NCT00261846|Secondary|Number of Participants Who Received Concomitant Medications for Management of Adverse Events (AEs)|Number of participants taking any non-study medications which were administered from Study Day 1 to 30 days after last dose of study treatment as a management of an AE are reported.|Baseline and Weeks 1, 2, 3, 4, 8, 12, then every 12 weeks thereafter until end of treatment, for a mean duration of 28 months|Safety population included all participants who receive at least one dose of study medication.||participants|||Number
716742|NCT00261846|Secondary|Number of Participants With Change From Baseline in Findings of Chest X-ray|Number of participants whose chest X-ray results changed (worsened or improved) from the Baseline.|Baseline, Week 8, and end of treatment|Safety population included all participants who received at lease one dose of study medication.||participants|||Number
716743|NCT00261846|Secondary|Percentage of Participants With On-treatment PCI Change From Baseline in Electrocardiogram (ECG) Findings|Criteria for PCI changes in ECG (12-lead) were defined as: no sinus rhythm; PR interval >=220 msec and increase of >=20 msec; QRS interval >=120 msec; QT interval corrected using the Fridericia formula (QTcF) and QT interval corrected using the Bazett formula (QTcB) >500 msec or increase of >60 msec; heart rate <=45 beats per minute (bpm) or >=120 bpm or decrease/increase of >=15 bpm.|Baseline, 0 (pre-dose), 2, 4, 6 hours on Day 1, 0 (pre-dose), 2, 4, 6, 20-23 hours on Day 21, and end of treatment visit|Safety population included all participants who receive at least one dose of study medication. 'N' (Number of Participants Analyzed) signifies number of participants who were evaluable for this measure.||Percentage of participants|||Number
716744|NCT00261846|Secondary|Percentage of Participants With Change From Baseline in Laboratory Tests Results|Laboratory assessments included urinalysis, complete blood count (CBC), prothrombin time/partial prothromboplastin time (PT/PPT), international normalized ratio (INR), blood chemistry and serum pregnancy test (β-HCG). Parameters of special interest included liver function tests and those related to myelosuppression. Potentially clinically important (PCI) laboratory values were defined as National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 (NCI CTCAE v3.0) grade 3 or higher. Maximum CTCAE grade, and only participants who shifted to Grade 3/4 on-treatment, are reported.|Week 1, 2, 3, 4, 8, 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks thereafter|Safety population included all participants who receive at least one dose of study medication.||Percentage of Participants|||Number
716772|NCT00261846|Primary|Area Under the Concentration-Time Curve (AUC) - Part 1|"AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
NA = not estimable."|0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1|Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this measure.||ng*hr/mL||Standard Deviation|Mean
716745|NCT00261846|Secondary|Duration of Potentially Clinically Important (PCI) Adverse Events (AEs)|"An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. The event did not necessarily have a causal relationship with the treatment. PCI AEs included anemia, alanine aminotranferase (ALT), aspartate aminotransferase (AST), cardiac, diarrhea, edema, effusion, gastrointestinal, hemorrhage, hypersensitivity, hypertension, infection, liver, myelosuppression, nausea, neutropenia, rash, renal, thrombocytopenia, vomiting, and vascular events. Duration of AE was calculated as (stop date minus start date) plus 1 for non-missing and non-partial dates.
NA = not estimable."|Baseline up to follow-up visit (30 days after last dose of study treatment)|Safety population included all participants who receive at least one dose of study medication.||days||Full Range|Median
716746|NCT00261846|Secondary|Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to follow up visit (30 days after last dose of study treatment)|Safety population included all participants who receive at least one dose of study medication.||percentage of participants|||Number
716747|NCT00261846|Secondary|Percentage of Participants With Overall Hematologic Response (OHR) by Week 48 in Advanced Leukemia Population - Part 2|OHR included CHR, no evidence of leukemia (≤5% bone marrow blasts, no peripheral blood blasts or promyelocytes, <5% myelocytes + metamyelocytes in blood, white blood cells ≤ institutional upper limit of normal, 450x10^9/L > platelets > 20x10^9/L, absolute neutrophil count ≥0.5x10^9/L, <20% basophils in blood, no extramedullary involvement [including liver or spleen]), minor hematologic response (acute lymphoblastic leukemia [ALL] patients only, defined as <15% blasts in marrow & blood, <30% blasts + promyelocytes in marrow & blood, <20% basophils in peripheral blood & no extramedullary disease other than spleen & liver) or return to chronic phase (AP/BP participants, defined as <15% blasts in both peripheral blood &bone marrow, <30% blasts + promyelocytes in both peripheral blood & bone marrow, <20% basophils in both peripheral blood & bone marrow, no extramedullary Involvement other than liver or spleen). Participants had to meet at least 1 criterion.|Day 1 and 7 of Week 1, Day 7 of Week 2, 3, 4, 8, 12, thereafter assessed every 12 weeks up to 1 year|Hematologic evaluable population included all enrolled participants who received at least one dose of study medication and had an adequate baseline hematologic assessment.||percentage of participants||95% Confidence Interval|Number
716748|NCT00261846|Secondary|Percentage of Participants With Confirmed Complete Hematologic Response (CHR) - Part 2|Hematologic response: if participants met all of the following criteria of CHR: White Blood Cells ≤ institutional upper limit of normal, no peripheral blood blasts or promyelocytes, myelocytes+metamyelocytes <5% in blood, absolute neutrophil count ≥ 1.0×10^9/L , platelets <450×10^9/L, platelets ≥100×10^9/L, <20% basophils in blood and no extramedually involvement (including hepato- or splenomegaly), ≤5% BM blasts (required for ADV only and applicable to CP if BM aspirate was performed).|Day 1 and 7 of Week 1, Day 7 of Week 2, 3, 4, 8, 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks thereafter up to Year 4 (CP3L and ADV) or Year 5 (CP2L)|Hematologic evaluable population included all enrolled participants who received at least one dose of study medication and had an adequate baseline hematologic assessment.||percentage of participants||95% Confidence Interval|Number
716749|NCT00261846|Secondary|Overall Survival (OS) - Part 2|"OS was based on Kaplan-Meier method. Survival was defined as the time period from the date of first dose of bosutinib to the date of death or date of last contact for those censored.
NA = not estimable. One year = 12 months."|Years 1, 2, 3, 4, and 5 (CP2L only)|All-treated population included all enrolled participants who received at least 1 dose of study medication.||Months||95% Confidence Interval|Median
716750|NCT00261846|Secondary|Kaplan-Meier Estimate of Overall Survival (OS) - Part 2|"OS was based on Kaplan-Meier method. Survival was defined as the time period from the date of first dose of bosutinib to the date of death or date of last contact for those censored.
NA = not estimable. One year = 12 months."|Years 1, 2, 3, 4, and 5 (CP2L only)|All-treated population included all enrolled participants who received at least 1 dose of study medication.||percentage of participants||95% Confidence Interval|Number
716751|NCT00261846|Secondary|Progression Free Survival (PFS) - Part 2|"PFS was based on Kaplan-Meier method. Disease progression was determined by the investigator as the reason for treatment discontinuation and death was due to any cause within 30 days of last dose. Duration in months = (date of PD/death or last valid cytogenetic/hematologic assessment if censored - first dose date)/30.4.
NA = not estimable. One year = 12 months"|Years 1, 2, 3, 4, and 5 (CP2L only)|All-treated population included all enrolled participants who received at least one dose of study medication.||Months||95% Confidence Interval|Median
716752|NCT00261846|Secondary|Cumulative Incidence of Progression/Death - Part 2|"The cumulative incidence of on-treatment progression or death adjusting for the competing risk of treatment discontinuation without the event. Disease progression was determined by the investigator as the reason for treatment discontinuation and death was due to any cause within 30 days of last dose. Duration in months = (date of PD/death or last valid cytogenetic/hematologic assessment if censored - first dose date)/30.4. 95% confidence intervals were calculated using Gray’s method.
NA = not estimable. One year = 12 months."|Years 1, 2, 3, 4, and 5 (CP2L only)|All-treated population included all enrolled participants who received at least one dose of study medication.||percentage of participants||95% Confidence Interval|Number
716753|NCT00261846|Secondary|Time to Achieve Complete Hematologic Response (CHR) for Responders Only - Part 2|The time to CHR was measured from the date of first dosing to the first date of response. Time to response in weeks = (event date - first dose date plus 1)/7, where the event date is the non-missing date of the first attained response for responders only.|Day 1 and 7 of Week 1, Day 7 of Week 2, 3, 4, 8, 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks thereafter up to Year 4 (CP3L and ADV) or Year 5 (CP2L)|Hematologic evaluable population included all enrolled participants who received at least one dose of study medication and had an adequate baseline hematologic assessment - responders only.||weeks||95% Confidence Interval|Median
721296|NCT00307047|Secondary|Ischemia Driven Target Vessel Failure (TVF)|Defined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR|1 year|ITT, @ 1 yr||percentage of participants|||Number
716754|NCT00261846|Secondary|Duration of Complete Hematologic Response (CHR) - Part 2|"Hematologic response: if participants met all of the following criteria of CHR: White Blood Cells equal to or less than (≤) institutional upper limit of normal, no peripheral blood blasts or promyelocytes, myelocytes+metamyelocytes less than (<)5% in blood, absolute neutrophil count greater than or equal to (≥) 1.0×10^9 per liter (/L) , platelets <450×10^9/L, platelets ≥100×10^9/L, <20% basophils in blood and no extramedually involvement (including hepato- or splenomegaly), ≤5% BM blasts (required for ADV only and applicable to CP if BM aspirate was performed). The duration of CHR was defined as the interval from the first date of response until the first date of confirmed loss of response. Duration of response in weeks =(date of confirmed loss of attained response or last valid hematologic assessment for those censored - date of first confirmed response)/7.
NA = not estimable."|From date of first confirmed CHR to loss of CHR or censoring, assessed at Day 1 and 7 of Week 1, Day 7 of Week 2, 3, 4, 8, 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks thereafter up to Year 4 (CP3L and ADV) or Year 5 (CP2L)|Subgroup of participants from evaluable population who had confirmed CHR.||weeks||95% Confidence Interval|Median
716755|NCT00261846|Secondary|Kaplan-Meier Estimate of Maintaining Complete Hematologic Response (CHR) at Year 4 (CP3L and ADV) or Year 5 (CP2L) - Part 2|"Hematologic response: if participants met all of the following criteria of CHR: White Blood Cells equal to or less than (≤) institutional upper limit of normal, no peripheral blood blasts or promyelocytes, myelocytes+metamyelocytes <5% in blood, absolute neutrophil count greater than or equal to (≥) 1.0×10^9 per liter (/L) , platelets ≥100×10^9/L & <450×10^9/L, <20% basophils in blood & no extramedually involvement (including hepato- or splenomegaly), ≤5% BM blasts (ADV only & applicable to CP if BM aspirate was performed). The duration of CHR was defined as the interval from the first date of response until the first date of confirmed loss of response. Duration of response in weeks =(date of confirmed loss of attained response or last valid hematologic assessment for those censored - date of first confirmed response)/7. The Kaplan-Meier estimate of maintaining CHR at the end of minimum follow-up is presented (CP2L: Year 5; CP3L & ADV: Year 4). NA = not estimable.
NA = not estimable."|From date of first confirmed CHR to loss of CHR or censoring, assessed at Day 1 and 7 of Week 1, Day 7 of Week 2, 3, 4, 8, 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks thereafter up to Year 4 (CP3L and ADV) or Year 5 (CP2L)|Subgroup of participants from evaluable population who had confirmed CHR.||% estimate of maintaining response||95% Confidence Interval|Number
716756|NCT00261846|Secondary|Time to Achieve Major Cytogenetic Response (MCyR) in Chronic Phase Second-line CML for Responders Only - Part 2|"MCyR was categorized as either CCyR or PCyR. CCyR was achieved when there was 0% Ph+ cells from at least 20 metaphases from conventional bone marrow cytogenetics or <1% positive cells from at least 200 cells analyzed from FISH. PCyR was achieved when 1 to 35% Ph+ cells were present. Time to MCyR was the interval from the date of first dose of study medication until the first date of achieving a given response.
Time to response in weeks equals (=) (event date minus (-) first dose date plus (+) 1)divided (/)7, where the event date is the non-missing date of the first attained response for responders only."|Week 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks thereafter up to Year 5|Cytogenetic evaluable population included all enrolled participants who received at least one dose of study medication and had an adequate baseline cytogenetic assessment.||weeks||95% Confidence Interval|Median
716757|NCT00261846|Secondary|Kaplan-Meier Estimate of Retaining an Attained/Maintained Major Cytogenetic Response (MCyR) at Year 5 in Chronic Phase Second-line CML - Part 2|MCyR was categorized as either CCyR or PCyR. CCyR was achieved when there was 0% Ph+ cells from at least 20 metaphases from conventional bone marrow cytogenetics or <1% positive cells from at least 200 cells analyzed from FISH. PCyR was achieved when 1 to 35% Ph+ cells were present. The Kaplan-Meier probability of retaining an attained/maintained MCyR at Year 5 is reported. Median durations were not reached as of the minimum follow-up. Duration of response in weeks =(date of confirmed loss of first attained response or last valid cytogenetic assessment for those censored - date of first attained response)/7.|From first MCyR to loss of MCyR or censoring, assessed every 12 weeks up to 2 years and then every 24 weeks thereafter up to Year 5|Subgroup of participants from evaluable population who had MCyR.||% probability of retaining MCyR||95% Confidence Interval|Number
716758|NCT00261846|Secondary|Percentage of Participants With Major Cytogenetic Response (MCyR) in Chronic Phase Second-line and Chronic Phase Third-line CML Population - Part 2|CyR is based on the prevalence of Ph+ cells. MCyR was categorized as either CCyR or PCyR. CCyR was achieved when there was 0% Ph+ cells from at least 20 metaphases from conventional bone marrow cytogenetics or <1% positive cells from at least 200 cells analyzed from FISH. PCyR was achieved when 1 to 35% Ph+ cells were present.|Week 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks thereafter up to Year 4 (CP3L) or Year 5 (CP2L)|Cytogenetic evaluable population included all enrolled participants who received at least one dose of study medication and had an adequate baseline cytogenetic assessment.||percentage of participants||95% Confidence Interval|Number
716759|NCT00261846|Secondary|Percent Change From Baseline in Phosphorylation Inhibition of Crk Like Protein (CrkL) at Day 1, 8 and 15 - Part 1|"CrkL is a protein, phosphorylation of which has been shown to correlate with CML cell growth; and conversely inhibition of their phosphorylation correlates with inhibition of tumor cell growth. Phosphorylation of CrkL was monitored in whole blood cells, as well as in the CD3+ (T cell), CD19+ (B cell) and CD34+ (blast cell) compartments by using FACS flow cytometry.
NA = not estimable."|6 hours post-dose on Day 1, 0 (pre-dose), 6 hours post-dose on Day 8, 15|Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment. 'N' signifies number of participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time points for each arm group respectively.||percent change||Standard Deviation|Mean
716760|NCT00261846|Secondary|Phosphorylation Inhibition of Crk Like (CrkL) Protein at Baseline - Part 1|CrkL is a protein, phosphorylation of which has been shown to correlate with CML cell growth; and conversely inhibition of their phosphorylation correlates with inhibition of tumor cell growth. Phosphorylation of CrkL was monitored in whole blood cells, as well as in the cluster of differentiation 3 (CD3+) (T cell), CD19+ (B cell) and CD34+ (blast cell) compartments by using fluorescent activated cell sorter (FACS) flow cytometry.|0 (pre-dose) on Day 1 (Baseline)|Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this measure.||mol/100 cells||Standard Deviation|Mean
716761|NCT00261846|Secondary|Phosphorylation Inhibition of Breakpoint Cluster Region-Abelson Kinase (Bcr-Abl) - Part 1|bcr-Abl is a protein resulting from the transcription of the Philadelphia chromosome following 9:22 chromosomal translocation, and phosphorylation inhibition of which correlates with inhibition of tumor cell growth.|Baseline, Weeks 4, 8, 12, 24, 36, 48 and the end of the active treatment phase of Part 1 (Week 52)|Data was not summarized since inadequate data included the issue that molecular transcript analyses could not be performed, because of potential sample quality issues due to time required to transport the specimens from the few investigational sites to the central laboratory.|||||
716762|NCT00261846|Secondary|Percentage of Participants With Major Cytogenetic Response (MCyR) - Part 1|Cytogenetic response (CyR) is based on the prevalence of Philadelphia positive (Ph+) cells. Major cytogenetic response was categorized as either complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). CCyR was achieved when there was 0% Ph+ cells from at least 20 metaphases from conventional bone marrow cytogenetics or <1% positive cells from at least 200 cells analyzed from FISH. PCyR was achieved when 1 to 35% Ph+ cells were present.|Weeks 12, 24, 36, 48 and the end of active treatment phase of Part 1 (Week 52)|Cytogenetic evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline cytogenetic assessment.||percentage of participants||95% Confidence Interval|Number
716763|NCT00261846|Primary|Percentage of Participants With MCyR at Week 24 in Chronic Phase Second-line Imatinib Resistant CML Population - Part 2|CyR is based on the prevalence of Ph+ cells. Major cytogenetic response was categorized as either CCyR or partial CyR (PCyR). CCyR was achieved when there was 0 percent (%) Ph+ cells from at least 20 metaphases from conventional bone marrow cytogenetics or less than (<) 1% positive cells from at least 200 cells analyzed from fluorescent in situ hybridization (FISH). PCyR was achieved when 1 to 35% Ph+ cells were present.|Week 24|Cytogenetic evaluable population included all enrolled participants who received at least one dose of study medication and had an adequate baseline cytogenetic assessment.||percentage of participants||95% Confidence Interval|Number
716764|NCT00261846|Primary|Accumulation Ratio (R)|R=accumulation ratio (AUCss on Day 15/AUC0-24 on Day 1)|0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 1 and Day 15|Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this measure.||ratio||Standard Deviation|Mean
716765|NCT00261846|Primary|Apparent Oral Clearance at Steady State (CL/F,ss) - Part 1|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. Apparent oral clearence over 24 hours at steady state (ss), on Day 15 was calculated.|0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 15|Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this measure.||L/hr||Standard Deviation|Mean
716766|NCT00261846|Primary|Area Under the Concentration-Time Curve at Steady State (AUCss) - Part 1|AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. AUC over 24 hours at steady state (ss), on Day 15 was calculated.|0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 15|Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this measure.||ng*hr/mL||Standard Deviation|Mean
716767|NCT00261846|Primary|Plasma Decay Half-Life at Steady State (t1/2,ss) - Part 1|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Plasma decay half-life over 24 hours at steady state (ss), on Day 15 was calculated.|0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 15|Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this measure.||hrs||Standard Deviation|Mean
716768|NCT00261846|Primary|Time to Reach Maximum Observed Plasma Concentration at Steady State (Tmax,ss) - Part 1|Time to reach maximum observed plasma concentration over 24 hours at steady state (ss), on Day 15.|0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 15|Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment.||hrs||Full Range|Median
716769|NCT00261846|Primary|Maximum Observed Plasma Concentration at Steady State (Cmax,ss) - Part 1|Maximum plasma concentration over 24 hours at steady state (ss), on Day 15.|0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 15|Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this measure.||ng/mL||Standard Deviation|Mean
716770|NCT00261846|Primary|Apparent Volume of Distribution (Vz/F) - Part 1|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1|Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this measure.||liter||Standard Deviation|Mean
716771|NCT00261846|Primary|Apparent Oral Clearance (CL/F) - Part 1|"Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
NA = not estimable."|0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1|Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this measure.||liter per hour (L/hr)||Standard Deviation|Mean
716774|NCT00261846|Primary|Plasma Decay Half-Life (t1/2) - Part 1|"Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
NA = not estimable."|0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1|Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this measure.||hrs||Standard Deviation|Mean
716775|NCT00261846|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) - Part 1||0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1|Evaluable population included all enrolled participants who received at least one dose of study medication and had an adequate baseline efficacy assessment.||hours (hrs)||Full Range|Median
716776|NCT00261846|Primary|Maximum Observed Plasma Concentration (Cmax) - Part 1||0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1|Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
716777|NCT00261846|Primary|Maximum Tolerated Dose (MTD)|"MTD was defined as highest dose level for which no more than 1 participant in a dose cohort experienced DLT. DLT was defined as any of the following events occurring during the first 28 days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 clinically-relevant non-hematologic toxicity, any clinically-significant grade 2 non-hematologic toxicity that requires 14 days to resolve (to grade 1).
NA = not estimable."|Part 1 Baseline up to Day 28|Safety population included all participants who received at least 1 dose of study medication||mg|||Number
716778|NCT00261846|Primary|Number of Participants With Dose Limiting Toxicity (DLT)|DLT was defined as any of the following events occurring during the first 28 days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 clinically-relevant non-hematologic toxicity, any clinically-significant grade 2 non-hematologic toxicity that requires 14 days to resolve (to grade 1).|Part 1 Baseline up to Day 28|Safety population included all participants who received at least 1 dose of study medication.||participants|||Number
716779|NCT00261950|Secondary|Percent Change From Baseline in Tartrate Resistant Acid Phosphatase(TRAP) at Week 52||Baseline to week 52|Enrolled subjects with TRAP at week 52||percent change||Standard Error|Mean
716780|NCT00261950|Secondary|Percent Change From Baseline in Osteocalcin (OC) at Week 52||Baseline to week 52|Enrolled subjects with osteocalcin (OC) at week 52||Percent change||Standard Error|Mean
716781|NCT00261950|Secondary|Change From Baseline to End of Study in Eroded Perimeter/Bone Perimeter|"Eroded Perimeter/Bone Perimeter was calculated as Eroded Perimeter/Bone Perimeter * 100"|Baseline to week 52|Enrolled subjects with eroded perimeter/bone perimeter at week 52||percentage of bone perimeter||Standard Error|Mean
716782|NCT00261950|Secondary|Change in Categorization From Baseline to End of Study in Fibrosis Area/Tissue Area|Categorisation at each timepoint was based on fibrosis area as a percentage of tissue area (Fibrosis Area/Tissue Area * 100)|Baseline to week 52|Enrolled subjects with Fibrosis Area/Tissue Area at week 52||participants|||Number
716783|NCT00261950|Secondary|Change From Baseline to End of Study in Osteoclast Perimeter (Osteoclast Perimeter/Eroded Perimeter)|"Osteoclast Perimeter was calculated as Osteoclast Perimeter/Eroded Perimeter * 100"|Baseline to week 52|Enrolled subjects with Osteoclast Perimeter at week 52||percentage of eroded perimeter||Standard Error|Mean
716784|NCT00261950|Secondary|Change From Baseline to End of Study in Osteoblast Perimeter (Osteoblast Perimeter/Osteoid Perimeter)|"Osteoblast Perimeter was calculated as Osteoblast Perimeter/Osteoid Perimeter * 100"|Baseline to week 52|Enrolled subjects with Osteoblast Perimeter at week 52||percentage of osteoid perimeter||Standard Error|Mean
716785|NCT00261950|Primary|Change From Baseline to End of Study in Bone Formation Rate (BFR)||Baseline to week 52|Enrolled subjects with bone biopsy at week 52||μm^2/mm^2/day||Standard Error|Mean
716786|NCT00261950|Secondary|Percent Change From Baseline in Parathyroid Hormone (PTH) During the Efficacy Assessment Phase (EAP)||Baseline to weeks 40-52|Enrolled subjects with PTH during the Efficacy Assessment Phase (EAP)||percent change||Standard Error|Mean
716787|NCT00261950|Secondary|Percent Change From Baseline in N – Telopeptide (NTx) at Week 52||Baseline to week 52|Enrolled subjects with NTx at week 52||percent change||Standard Error|Mean
716788|NCT00261950|Secondary|Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BALP) at Week 52||Baseline to week 52|Enrolled subjects with BALP at week 52||percent change||Standard Error|Mean
716789|NCT00261950|Secondary|Percent Change From Baseline in Ca x P During the Efficacy Assessment Phase (EAP)||Baseline to weeks 40-52|Enrolled subjects with Ca x P during the Efficacy Assessment Phase (EAP)||percent change||Standard Error|Mean
716790|NCT00261950|Secondary|Percent Change From Baseline in Serum Phosphorus During the Efficacy Assessment Phase (EAP)||Baseline to weeks 40-52|Enrolled subjects with serum phosphorus during the Efficacy Assessment Phase (EAP)||percent change||Standard Error|Mean
716791|NCT00261950|Secondary|Percent Change From Baseline in Serum Calcium During the Efficacy Assessment Phase (EAP)||Baseline to weeks 40-52|Enrolled subjects with serum calcium during the Efficacy Assessment Phase (EAP)||percent change||Standard Error|Mean
716792|NCT00262002|Secondary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age|The safety profile of Novartis MenACWY Ad+ and MenACWY Ad- conjugate vaccines when given at 12 months of age.|7 days after vaccination at 12 months of age|"Analysis was done on safety dataset n population."||subjects|||Number
716793|NCT00262002|Secondary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad-|Safety and tolerability of Novartis MenACWY Ad+ and MenACWY Ad- conjugate vaccine when given in a 2 or 3 dose primary vaccination series concomitantly with licensed pediatric vaccines.|7 days after each vaccination|"Analysis was done on safety dataset n population - subjects who received at least one study dose and had Post baseline safety data."||subjects|||Number
716805|NCT00262002|Secondary|Geometric Mean hSBA Titers (GMTs) After 2 Doses of Novartis MenACWY Ad+ Vaccines, Novartis MenACWY Ad- Vaccine, or Novartis Menjugate Vaccine.|The persistence of immune response as measured by hSBA GMT and associated 95% CI against N. Meningitidis serogroups A, C, W, and Y, at 12 months of age by groups.|at 12 months of age|"The analysis was performed on the MenACWY and Menjugate per-protocol (PP) n population evaluating the persistence response."||titers||95% Confidence Interval|Geometric Mean
716794|NCT00262002|Secondary|Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroup C Following 2 Doses of MenACWY Ad+ or Ad- Conjugate Vaccine (Containing 5 μg of MenC Oligosaccharide) or 2 Doses of Menjugate (Containing 10 μg of MenC Oligosaccharide)|The immunogenicity was measured as percentages of subjects with hSBA ≥ 1:4 and ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroup C, at baseline and 1 month after second vaccination by groups.|Baseline and 1 month after second vaccination|"The analysis was performed on the MenACWY and Menjugate per-protocol (PP) n population after second vaccination."||percentages of subjects||95% Confidence Interval|Number
716795|NCT00262002|Secondary|ELISA GMT Concentrations for Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines for Hib, Diphtheria, Tetanus, Hepatitis B|To assess the Enzyme-linked immunosorbent assay (ELISA) GMT of Hib, Diphtheria, Tetanus, Hepatitis B, administered Concomitantly with Novartis MenACWY Ad+ or MenACWY Ad-conjugate vaccines, at the baseline and 1 month after primary vaccination by groups.|Baseline and 1 month after the 2 or 3 dose primary vaccination series|"The analysis was performed on the MenACWY per-protocol (PP) n population after primary vaccination."||titers||95% Confidence Interval|Geometric Mean
716796|NCT00262002|Secondary|Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines|To assess the immunogenicity of routine vaccines when given concomitantly to Novartis MenACWY Ad+ or Novartis MenACWY Ad- conjugate vaccines. Hib, diphtheria, tetanus, pertussis will be evaluated as the first priority, followed by pneumococcus, polio, hepatitis B, and MMR (measles, mumps, and rubella) depending on the availability of sera.|Baseline and 1 month after the 2 or 3 dose primary vaccination series|"The analysis was performed on the MenACWY per-protocol (PP) n population after primary vaccination."||percentages of subjects||95% Confidence Interval|Number
716797|NCT00262002|Secondary|Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 in Subjects Challenged With a Reduced Dose of a Licensed Meningococcal ACWY PS Vaccine Following 2 or 3 Doses of MenACWY Ad+ Conjugate Vaccine|The memory response was measured as percentages of subjects with hSBA ≥ 1:4 and hSBA ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y, at 12 months of age and 1 month after PS challenge by groups.|at 12 months of age and 1 month after PS challenge|"The analysis was performed on the MenACWY per-protocol (PP) n population evaluating the persistence response."||percentages of subjects||95% Confidence Interval|Number
716798|NCT00262002|Secondary|Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine|The immunogenicity was measured as percentages of subject with hSBA≥ 1:4 and hSBA ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y, baseline and 1 month after 2 or 3 dose primary series by groups.|Baseline and 1 month after the 2 or 3 dose primary vaccination series|"The analysis was performed on the MenACWY per-protocol (PP) n population after primary vaccination."||percentages of subjects||95% Confidence Interval|Number
716799|NCT00262002|Secondary|Geometric Mean hSBA Titers (GMTs) in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine|Induction of immunological memory was measured by hSBA Geometric Mean Titers (GMTs) and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y, before challenge at 12 months and 1 month after PS challenge by groups.|Before challenge at 12 months of age and 1 month after PS challenge.|"The analysis was performed on the MenACWY per-protocol (PP) n population evaluating the persistence response."||titers||95% Confidence Interval|Geometric Mean
716800|NCT00262002|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine|The Induction of immunological memory was measured as percentage of subjects with hSBA ≥ 1:4, hSBA ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y, before challenge at 12 months and 1 month after PS challenge by groups.|Before challenge at 12 months of age and 1 month after PS challenge.|"The analysis was performed on the MenACWY per-protocol (PP) n population evaluating the persistence response."||percentages of subjects||95% Confidence Interval|Number
716801|NCT00262002|Secondary|Geometric Mean hSBA Titers (GMTs) in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine|The induction of immunological memory was measured as hSBA Geometric Mean Titers (GMTs) and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y , before challenge at 12 months of age and 1 month after PS challenge.|before challenge at 12 months of age and 1 month after PS challenge.|"The analysis was performed on the MenACWY per-protocol (PP) n population evaluating the persistence response."||titers||95% Confidence Interval|Geometric Mean
716802|NCT00262002|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine|The induction of immunological memory was measured as percentages of subjects with hSBA ≥ 1:4 and hSBA ≥ 1:8 and associated 95% CI, against N. Meningitidis serogroups A, C, W, and Y , before challenge at 12 months of age and 1 month after PS challenge.|before challenge at 12 months of age and 1 month after PS challenge.|"The analysis was performed on the MenACWY per-protocol (PP) n population evaluating the persistence response."||percentages of subjects||95% Confidence Interval|Number
716803|NCT00262002|Secondary|Geometric Mean hSBA Titers (GMTs) Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine|The persistence of immune response as measured by hSBA GMTs and associated 95% CI against N. Meningitidis serogroups A, C, W, and Y,at 12 months by groups.|at 12 months of age|"The analysis was performed on the MenACWY per-protocol (PP) n population evaluating the persistence response."||Titers||95% Confidence Interval|Geometric Mean
716804|NCT00262002|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroup A, C, W and Y Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine|The persistence of immune response as measured by percentages of subjects with hSBA≥ 1:4 and hSBA ≥ 1:8 and associated 95% CI, against N. Meningitidis serogroups A, C, W, and Y, at 12 months by groups.|at 12 months of age|"The analysis was performed on the MenACWY per-protocol (PP) n population evaluating the persistence response."||percentages of subjects||95% Confidence Interval|Number
721297|NCT00307047|Secondary|Ischemia Driven Target Vessel Failure (TVF)|Defined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR|270 days|||percentage of participants|||Number
716806|NCT00262002|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 2 Doses of Novartis MenACWY Ad+ Vaccine, Novartis MenACWY Ad- Vaccine or Novartis Menjugate Vaccine|The persistence of immune response was measured as the percentages of subjects with hSBA ≥ 1:4 and ≥ 1:8 against N. Meningitidis serogroups A, C, W, and Y at 12 months of age by groups.|at 12 months of age|"The analysis was performed on the MenACWY and Menjugate per-protocol (PP) n population evaluating the persistence response."||percentages of subjects||95% Confidence Interval|Number
716807|NCT00262002|Secondary|Geometric Mean hSBA Titers (GMT) After a Booster Dose of MenACWY Ad+ or Ad- Vaccine Conjugate in a Subgroup of Subjects Following Either 2 or 3 Doses of MenACWY Ad+ Vaccine or 2 Doses of MenACWY Ad- Conjugate Vaccines|Immunogenicity was measured as GMT and associated 95% CI against N. Meningitidis serogroups A, C, W, and Y, at 12 months of age and 1 month after booster by group.|at 12 months of age and 1 month after booster vaccination|"The analysis was performed on the MenACWY per-protocol (PP) n population evaluating the persistence response."||titers||95% Confidence Interval|Geometric Mean
716808|NCT00262002|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine|Immunogenicity was measured as the percentages of subjects with hSBA ≥ 1:4 or ≥ 1:8 and associated 95% CI, against N. Meningitidis serogroups A, C, W, and Y, at 12 months of age and 1 month after booster by groups.|at 12 months of age and 1 month after booster vaccination|"The analysis was performed on the MenACWY per-protocol (PP) n population evaluating the persistence response."||percentages of subjects||95% Confidence Interval|Number
716809|NCT00262002|Secondary|Geometric Mean hSBA Titer (GMTs) Following 2 Doses of MenACWY Ad+ and MenACWY Ad- Conjugate Vaccines|Immunogenicity was measured as hSBA GMTs and associated 95% CI against N. Meningitidis serogroups A, C, W, and Y at baseline and 1 month after second vaccination by groups.|Baseline and 1 month after second vaccination|"The analysis was performed on the MenACWY per-protocol (PP) n population"||titers||95% Confidence Interval|Geometric Mean
716810|NCT00262002|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines|Immunogenicity was measured as the percentages of subjects With hSBA titers ≥ 1:4 and ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y, at Baseline and 1 month after second vaccination by groups.|Baseline and 1 month after second vaccination|"The analysis was performed on the MenACWY per-protocol (PP) n population."||percentages of subjects||95% Confidence Interval|Number
716811|NCT00262002|Secondary|Geometric Mean hSBA Titers (GMTs) Following 3 Doses of MenACWY Ad+ Conjugate Vaccine|Immunogenicity was measured as hSBA GMTs and associated 95% CI, against N meningitis serogroups A, C, W, and Y, at the baseline and 1 month after primary vaccination by groups.|Baseline and 1 month after the 3 dose primary vaccination series|"The analysis was performed on the MenACWY per-protocol (PP) n population after primary vaccination."||titers||95% Confidence Interval|Geometric Mean
716812|NCT00262002|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Conjugate Vaccine|Immunogenicity was measured by percentages of subjects With hSBA titers ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W and Y, at baseline and 1 month after primary vaccination by groups.|Baseline and 1 month after the 3 dose primary vaccination series|"The analysis was performed on the MenACWY per-protocol (PP) n population after primary vaccination."||percentages of subjects||95% Confidence Interval|Number
716813|NCT00262002|Primary|Percentages of Subjects With hSBA Titers ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Vaccine|Immunogenicity was measured as the percentage of subjects with human serum bactericidal assay (hSBA) titers ≥ 1:4 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W and Y, at the baseline and 1 month after primary vaccination by groups.|Baseline and at 1 month after the 3 dose primary vaccination series|"The analysis was performed on the MenACWY per-protocol (PP) n population after primary vaccination."||percentages of subjects||95% Confidence Interval|Number
716814|NCT00262028|Secondary|Number of Subjects Reporting Unsolicited Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months|Safety and tolerability of a single dose of MenACWY-CRM conjugate vaccine when administered in healthy toddlers (12-15 months old), alone or concomitantly with PnC and when administered in healthy toddlers (16-23 months old), alone or concomitantly with DTaP.|Day 1- Day 360 (Throughout the study)|Analysis was done on safety population.||Subjects|||Number
716815|NCT00262028|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs) After Vaccination in Children Aged 2 to 10 Years|Safety and tolerability of a single dose of MenACWY-CRM conjugate vaccine compared to the safety and tolerability of a single dose of licensed MenACWY-PS vaccine when administered to healthy children 2 to 10 years of age.|Day 1- Day 360 (throughout the study)|Analysis was done on safety population.||Subjects|||Number
716816|NCT00262028|Secondary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months|Safety and tolerability of a single dose of MenACWY-CRM conjugate vaccine when administered in healthy toddlers (12-15 months old), alone or concomitantly with PnC and when administered in healthy toddlers (16-23 months old), alone or concomitantly with DTaP.|Day 1 to 7 post vaccination|Analysis was done on safety population.||Subjects|||Number
716817|NCT00262028|Secondary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years|Safety and tolerability of a single dose of MenACWY-CRM conjugate vaccine compared to the safety and tolerability of a single dose of licensed MenACWY-PS vaccine when administered to healthy children 2 to 10 years of age.|Day 1 to 7 post vaccination|Analysis was done on safety population i.e. all randomized subjects who received a vaccination and who had follow up safety data.||Subjects|||Number
716818|NCT00262028|Secondary|hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine|hSBA GMT against N. meningitidis serogroups A, C, W, and Y, in subjects (2-10 years, 2-5 years and 6-10 years old), twelve months after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine.|12 months post vaccination (Day 360)|Analysis was done on per protocol population.||Titer||95% Confidence Interval|Geometric Mean
721298|NCT00307047|Secondary|Ischemia Driven Target Vessel Failure (TVF)|Defined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR|180 days|||percentage of participants|||Number
716819|NCT00262028|Secondary|Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine|Number of subjects (2-10 years, 2-5 years and 6-10 years old subjects) with hSBA ≥ 1:4 directed against N. meningitidis serogroups A, C, W and Y, 12 months after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine.|12 months post vaccination (Day 360)|Analysis was done on per protocol population.||Subjects|||Number
716820|NCT00262028|Secondary|hSBA Geometric Mean Titer (GMT) in Subjects (12-23 Months Old) After Receiving MenACWY-CRM Vaccine Compared With hSBA GMT in 3-5 Year Old Subjects After Receiving MenACWY-PS Vaccine|hSBA GMT against N. meningitidis serogroups A, C, W, and Y, in subjects (12-23 months old), one month after receiving one dose of MenACWY-CRM vaccine compared with hSBA GMT in 3-5 year old subjects after receiving one dose of licensed MenACWY-PS vaccine.|1 month post vaccination (Day 29)|Analysis was done on per protocol population.||Titer||95% Confidence Interval|Geometric Mean
716821|NCT00262028|Secondary|hSBA GMT in Subjects (2-5 Years of Age and 6-10 Years of Age) Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine|hSBA GMT against N. meningitidis serogroups A, C, W, and Y, in subjects (2-5 years of age and 6-10 years of age), one month after receiving one dose of either MenACWY-CRM vaccine or licensed MenACWY-PS vaccine.|1 month post vaccination (Day 29)|Analysis was done on per protocol population.||Titer||95% Confidence Interval|Geometric Mean
716822|NCT00262028|Secondary|hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years of Age) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine|hSBA GMT against N. meningitidis serogroups A, C, W, and Y, in subjects (2-10 years of age), one month after receiving one dose of either MenACWY-CRM vaccine or the licensed MenACWY-PS vaccine.|1 month post vaccination (Day 29)|Analysis was done on per protocol population.||Titers||95% Confidence Interval|Geometric Mean
716823|NCT00262028|Secondary|Percentages of Subjects (12-23 Months Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-CRM Vaccine Compared With Percentage of Subjects (3-5 Years Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-PS Vaccine|Percentage of subjects (12-23 months old) with hSBA ≥ 1:4 directed against N. meningitidis serogroups A, C, W and Y after receiving one dose of MenACWY-CRM vaccine compared with percentage of subjects (3-5 years old) with hSBA ≥ 1:4 after one dose of licensed MenACWY-PS vaccine.|1 month post vaccination (Day 29)|Analysis was done on per protocol population.||Percentages of subjects||95% Confidence Interval|Number
716824|NCT00262028|Secondary|Percentages of Subjects (2-5 Years of Age and 6-10 Years of Age) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine|Percentages of subjects (2-5 years of age and 6-10 years of age) with hSBA ≥ 1:4 directed against N. meningitidis serogroups A, C, W and Y, one month after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine.|1 month post vaccination (Day 29)|Analysis was done on per protocol population. The total number of participants analyzed in the MenACWY-CRM (2-10 Years Old) group (282), is different respect with that reported in the Outcome Measure 1 (281). There, the largest number for each group across the 4 strains was reported (not all strains had a result from the lab-i.e. C strain).||Percentages of subjects||95% Confidence Interval|Number
716825|NCT00262028|Primary|Number of Subjects (2-10 Years of Age) With Human Serum Bactericidal Activity (hSBA) Titers ≥1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine|Number of subjects (2-10 years of age) achieving with hSBA titers ≥1:4 against Neisseria meningitidis serogroups A,C,W and Y, one month after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine.|1 month post vaccination (Day 29)|Analysis was done on per protocol population i.e. all subjects who received one dose of vaccine and provided serum samples at the relevant time points (day 1, day 29 and day 360) and had no major protocol deviation.||Subjects|||Number
716826|NCT00262041|Secondary|Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination|Safety was assessed as the number of subjects 11 to 17 years of age who reported solicited local and systemic adverse events from day 1 up to and including day 7 after the vaccination of either MenACWY-CRM conjugate vaccine, with adjuvant or without adjuvant or MenACWY-PS vaccine.|Day 1 to Day 7|Analysis was done on safety dataset - subjects who received at least one study dose and had Post baseline safety data.||Subjects|||Number
716827|NCT00262041|Secondary|hSBA Geometric Mean Titers (GMT) After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine|Immune response of one dose of MenACWY-CRM(Ad-) conjugate vaccine compared with that of MenACWY-PS vaccine, 12 months after administration in subjects 11 to 17 years of age, as measured by hSBA geometric mean titers (GMTs) against N meningitidis serogroups A, C, W, and Y.|12 months after vaccination|Analysis was done on PP population.||Titers||95% Confidence Interval|Geometric Mean
716828|NCT00262041|Secondary|Percentages of Subjects With hSBA Titers≥ 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine|Immune response of one dose of MenACWY-CRM(Ad-) compared to that of one dose of MenACWY polysaccharide(MenACWY-PS) vaccine, 12 months after administration to subjects aged 11 to 17 years, as measured by the percentage of subjects with human complement serum bactericidal activity (hSBA) titers≥1:4 against N meningitidis serogroups A, C, W, and Y. The endpoint point compares only data of unadjuvanted formulation of the conjugate vaccine to the polysaccharide vaccine.|12 months after vaccination|Analysis was done on PP population.||Percentages Of Subjects||95% Confidence Interval|Number
716829|NCT00262041|Secondary|hSBA Geometric Mean Titers (GMT) After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant or MenACWY-PS Vaccine|Immune response of one dose of MenACWY-CRM conjugate vaccine, with adjuvant or without adjuvant or MenACWY-PS vaccine, one month after administration in subjects 11 to 17 years of age, as measured by hSBA geometric mean titers (GMTs) against N meningitidis serogroups A, C, W, and Y.|1 month after vaccination|Analysis was done on per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
716830|NCT00262041|Primary|Percentages of Subjects With N.Meningitidis Human Serum Bactericidal Activity (hSBA) Titers≥ 1:4, After One Dose of Either MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, or MenACWY-PS Vaccine|Immune response of a single dose of MenACWY-CRM conjugate vaccine, with adjuvant or without adjuvant compared to that of one dose of MenACWY polysaccharide (PS) vaccine, one month after administration to subjects aged 11 to 17 years, as measured by the percentage of subjects with hSBA titers >1:4 directed against N meningitidis serogroups A, C, W and Y|1 month after vaccination|Analysis was done on the per-protocol population i.e all subjects who received all the relevant doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol violation.||Percentages Of Subjects||95% Confidence Interval|Number
716831|NCT00262067|Secondary|Progression-free Survival (PFS) as Determined by the Independent Review Committee Using Response Evaluation Criteria in Solid Tumors (RECIST)|PFS was defined as the time from randomization to first documented disease progression (PD) as determined by the Independent Review Committee using Response Evaluation Criteria in Solid Tumors (RECIST) or death due to any cause, whichever occurred first.|Baseline to the data cut-off date of 31 Jul 2008 (up to 2 years, 7 months)|Intent-to-treat population: All randomized patients, regardless of whether they received any study drug or completed the full course of treatment.||Months||95% Confidence Interval|Median
716832|NCT00262067|Secondary|1-year Survival|"1-year survival was defined as the percentage of patients who were alive 1 year after randomization.
The percentage of patients alive at 1 year was determined using Kaplan-Meier analyses and the 95% confidence intervals were computed using the Brookmeyer-Crowley method."|Baseline to the data cut-off of 23 Feb 2009 (up to 3 years, 2 months)|Intent-to-treat population: All randomized patients, regardless of whether they received any study drug or completed the full course of treatment.||Percentage of participants||95% Confidence Interval|Number
716833|NCT00262067|Secondary|Overall Survival|Overall survival was defined as the time from randomization until death from any cause.|Baseline to the data cut-off of 23 Feb 2009 (up to 3 years, 2 months)|Intent-to-treat population: All randomized patients, regardless of whether they received any study drug or completed the full course of treatment.||Months||95% Confidence Interval|Median
716834|NCT00262067|Secondary|Duration of Objective Response as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)|Duration of objective response was defined as the time from the first tumor assessment that led to a determination of an objective response to the time of disease progression or death due to any cause, whichever occurred first.|Baseline to the data cut-off date of 31 Jul 2008 (up to 2 years, 7 months)|Intent-to-treat population: All randomized patients, regardless of whether they received any study drug or completed the full course of treatment. Only patients with measurable disease at baseline and who had an objective response were included in the analysis.||Months||95% Confidence Interval|Median
716835|NCT00262067|Secondary|Objective Response as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)|An objective response was defined as a complete response or a partial response determined on two consecutive occasions ≥ 4 weeks apart as determined by the investigator using RECIST. For target lesions, a complete response was defined as the disappearance of all target lesions; a partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. For non-target lesions, a complete response was defined as the disappearance of all non-target lesions; a partial response was defined as the persistence of 1 or more non-target lesions.|Baseline to the data cut-off date of 31 Jul 2008 (up to 2 years, 7 months)|Intent-to-treat population: All randomized patients, regardless of whether they received any study drug or completed the full course of treatment. Only patients with measurable disease at baseline were included in the analysis.||Percentage of participants||95% Confidence Interval|Number
716836|NCT00262067|Primary|Progression-free Survival (PFS) as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)|PFS was defined as the time from randomization to first documented disease progression (PD) as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) or death due to any cause, whichever occurred first. For target lesions, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Target lesions should be selected on the basis of their size (those with the longest diameter) and their suitability for accurate repeated measurements by imaging techniques or clinically. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions.|Baseline to the data cut-off date of 31 Jul 2008 (up to 2 years, 7 months)|Intent-to-treat population: All randomized patients, regardless of whether they received any study drug or completed the full course of treatment.||Months||95% Confidence Interval|Median
716837|NCT00262080|Other Pre-specified|Time to Significant Improvement in Overall Response Over Multiple Treatment Episodes|The overall response assessment is a patient-reported assessment of global response to therapy. Patients are asked to perform an overall response assessment at regular intervals, relative to baseline (ie,immediately before treatment) using the following 5-category scale from significant improvement (Score = 100)to significant worsening (Score = -100)|4 hours post-dose (REPEAT-DOSING PART)|Patients not reporting significant improvement before 4 hours were censored at 4 hours. Patients receiving additional HAE therapy within 4 hours were censored at the time of the medical intervention. The time to significant improvement is not provided in this display as the interquartile range (IQR) was not reached by 4 hours for most episodes.||participants|||Number
716838|NCT00262080|Secondary|Time to Significant Improvement in Overall Response|"The overall response assessment is a patient-reported assessment of global response to therapy. Patients are asked to perform an overall response assessment at regular intervals, relative to baseline. Patients were asked overall how are you feeling compared to how they felt before study drug. Answer options were a lot worse, a little worse, same, a little better or a lot better or resolved. Significant improvement was the first time that the patient responded to the assessment as a little better or resolved."|4 hours post-dose (DOUBLE-BLIND PART)|ITT as treated. Patients not reporting significant improvement before 4 hours were censored at 4 hours. Patients receiving additional HAE therapy within 4 hours were censored at the time of the medical intervention. The time to significant improvement is not provided in this display as the median time for placebo was not reached by 4 hours.||participant|||Number
716860|NCT00262119|Secondary|Incidence of Cardiovascular Hospitalizations at 2 Years|Incidence, estimated via Kaplan Meier survival analysis, of cardiovascular hospitalizations at 2 years|2 years|Analysis was intention to treat therefore all randomized patients were analysed||percentage of participants||95% Confidence Interval|Number
716861|NCT00262119|Secondary|Incidence of Permanent Atrial Fibrillation at 2 Years|Incidence, estimated via Kaplan Meier survival analysis, of permanent atrial fibrillation at 2 years|2 years|The analysis was intention to treat therefore all randomized patients were analysed||percentage of participants||95% Confidence Interval|Number
716839|NCT00262080|Other Pre-specified|Change From Baseline in Mean Symptom Complex Severity (MSCS) Score at 4 Hours Post-dose Over Multiple Treatment Episodes|The Mean Symptom Complex Severity (MSCS) score is a validated, comprehensive point-in-time measure of symptom severity. At baseline and 4 hours, patients rated the severity on a categorical scale (0 = normal, 1 = mild, 2 = moderate, 3 = severe) for symptoms at each affected anatomical location. Ratings were averaged to obtain the MSCS score. A decrease in MSCS score reflected an improvement in symptoms; clinically meaningful improvement was indicated by a reduction in the score of 0.30 or more.|baseline, 4 hours post-dose (REPEAT-DOSING PART)|Treatment episode 1 contains data only from those participants who were new patients in the repeat-dosing part. Treatment episode 2 and beyond contain data pooled from patients treated in the double-blind part (ecallantide or placebo) and the repeat-dosing part. Data imputation was used to account for emerging symptoms and medical intervention.||units on a scale||Standard Deviation|Mean
716840|NCT00262080|Other Pre-specified|Treatment Outcome Score at 4 Hours Post-Dose Over Multiple Treatment Episodes|Treatment Outcome Score (TOS) is a validated, comprehensive measure of symptom response to treatment. At 4 hours , patient assessment of response characterized by their change from baseline in symptom severity and collected by anatomic site of attack involvement, was recorded on a categorical scale (significant improvement [100] to significant worsening [-100]). The response at each anatomic site was weighted by baseline severity and then the weighted scores across all involved sites were averaged to calculate the TOS. Clinically meaningful improvement was indicated by a TOS of 30 or higher.|4 hours post-dose (REPEAT-DOSING PART)|Treatment episode 1 contains data only from those participants who were new patients in the repeat-dosing part. Treatment episode 2 and beyond contain data pooled from patients treated in the double-blind part (ecallantide or placebo) and the repeat-dosing part. Data imputation was used to account for emerging symptoms and medical intervention.||units on a scale||Standard Deviation|Mean
716841|NCT00262080|Other Pre-specified|Number of Patients With Symptom Complexes of Treated Attack at Baseline(DOUBLE-BLIND PART)|Patient-reported severity of symptom complexes at baseline, by symptom complex and treatment group. Patients were to have at least one symptom complex that was moderate or severe. Patients could present with multiple symptom complexes, some of which could be mild. Mild=noticeable but do not impact daily living activities; Moderate=treatment or intervention is highly desirable and activities of daily living are impacted; Severe=require treatment or intervention due to inability to perform activities of daily living. The results are for number of patients with symptom complexes including mild, moderate and severe, provided the patients have at least one symptom complex that was moderate or severe|Baseline|||participants|||Number
716842|NCT00262080|Secondary|Change From Baseline in Mean Symptom Complex Severity (MSCS) Score at 4 Hours Post-dose|Mean Symptom Complex Severity (MSCS) score is a validated, comprehensive point-in-time measure of symptom severity. At baseline and 4 hours, patients rated the severity on a categorical scale (0 = normal, 1 = mild, 2 = moderate, 3 = severe) for symptoms at each affected anatomical location. Ratings were averaged to obtain the MSCS score. A decrease in MSCS score reflected an improvement in symptoms; clinically meaningful improvement (minimally important difference) was indicated by a reduction in the score of 0.30 or more.|baseline, 4 hours post-dose (DOUBLE-BLIND PART)|ITT as treated: two patients randomized on the same day at the same center were administered treatment opposite to their randomized treatment assignments. Data were analyzed based on their actual treatment received. Imputation was used to account for emerging symptoms and medical intervention. Best possible score = 0.0; worst possible score = 3.0.||units on a scale||Standard Deviation|Mean
716843|NCT00262080|Primary|Treatment Outcome Score at 4 Hours Post-Dose|Treatment Outcome Score (TOS) is a validated, comprehensive measure of symptom response to treatment. At 4 hours , patient assessment of response characterized by their change from baseline in symptom severity and collected by anatomic site of attack involvement, was recorded on a categorical scale (significant improvement [100] to significant worsening [-100]). The response at each anatomic site was weighted by baseline severity and then the weighted scores across all involved sites were averaged to calculate the TOS. Clinically meaningful improvement was indicated by a TOS of 30 or higher.|4 hours post-dose (DOUBLE-BLIND PART)|ITT as treated: two patients randomized on the same day at the same study center were administered treatment opposite to their randomized treatment assignment. Data were analyzed based on actual treatment received. Imputation was used to account for emerging symptoms and medical intervention. Best possible score = 100; worst possible score = -100.||units on a scale||Standard Deviation|Mean
716844|NCT00262119|Primary|Composite Endpoint Composed by Death for Any Cause, Cardiovascular Hospitalization or Permanent AF at 2 Years|The outcome measurement is the 2 years incidence, calculated by Kaplan Meier survival analysis, of the composite endpoint composed by death for any cause, cardiovascular hospitalization or permanent AF.|2 years|Analysis was intention to treat therefore all randomized patients were considered in the analyses||percentage of participants||95% Confidence Interval|Number
716845|NCT00262119|Secondary|Frequency, Type, and Associated Cost of Health Care Utilization and Utility||2 years||||||
716846|NCT00262119|Secondary|Time to Development of the Composite Endpoint Between All Randomized Subjects in the Three Arms in Subgroups of Patients||2 years||||||
716847|NCT00262119|Secondary|Clinical Outcome in All the Patients With MVP ON Between Patients With Optimized AV-delay and Patients Without Optimized AV-delay||2 years||||||
716848|NCT00262119|Secondary|Echocardiogram Data About Left Ventricular Fractional Shortening and Ejection Fraction and Left Atrium Dilatation||2 years||||||
716849|NCT00262119|Secondary|Predictors of Stroke, Transient Ischemic Attack (TIA) and Arterial Embolism||2 years||||||
716850|NCT00262119|Secondary|Development of Atrioventricular (AV) Block and Pacemaker Dependency||2 years||||||
716851|NCT00262119|Secondary|Adverse Events||2 years||||||
716852|NCT00262119|Secondary|Persistent Atrial Fibrillation (AF)||2 years||||||
716853|NCT00262119|Secondary|Atrial Fibrillation Burden||2 years||||||
716854|NCT00262119|Secondary|Any Hospitalization||2 years||||||
716855|NCT00262119|Secondary|Cardiovascular Death||2 years||||||
716856|NCT00262119|Secondary|Cumulative Percentage of Ventricular Pacing||2 years||||||
716857|NCT00262119|Secondary|Heart Failure Medications||2 years||||||
716858|NCT00262119|Secondary|Subjects' Symptoms||2 years||||||
716859|NCT00262119|Secondary|Burden of Composite Clinical Endpoint||2 years||||||
716867|NCT00262223|Primary|PTSD Symptom Severity / Clinician Administered PTSD Scale|Clinician Administered PTSD Scale (CAPS) is a 17-item, semi-structured interview of PTSD symptoms. Range of scores is 0-136. Five rationally derived severity score ranges for interpreting CAPS total score have been proposed: 0-19 = asymptomatic/few symptoms, 20-39 = mild PTSD/subthreshold, 40-59 = moderate PTSD/threshold, 60-79 = severe PTSD symptomatology, and >80 = extreme PTSD symptomology (Weathers et. al., 2001). A 15-point change in CAPS total severity score has been proposed as a marker of clinically significant change (Weathers et. al., 2001).|Baseline, End-of-treatment, 6-month follow-up and 12-month follow-up|||units on a scale||Standard Deviation|Mean
716868|NCT00262223|Primary|Heavy Drinking Days||Baseline, End-of-treatment, 6-month follow-up and 12-month follow-up|||Days||Standard Deviation|Mean
716869|NCT00262301|Secondary|Time to Minimal Symptoms|"the time to minimal symptoms was the time to minimal symptoms for an attack, assessed using the Visual Analogue Scale (VAS) score. Symptoms were said to be minimal when the VAS score at all locations was below 20 mm. Assessment time-points were: baseline (0 minutes), 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 48 hours. Time to minimal symptoms has been calculated by using the exact time-points on which each assessment was performed."|up to 48 hours after study drug administration|"The full analysis set (FAS or mITT) was defined as the set of patients who provided Informed Consent, were randomized and took at least one dose of study drug administration."||minutes||Full Range|Median
716870|NCT00262301|Primary|Time to Beginning of Relief of Symptoms|"The time to beginning of relief of symptoms has been assessed by using a patient-reported visual analogue scale (VAS) ranging from 0 mm (no symptoms at all) to 100 mm (extremely disabling). Time to beginning of relief of symptoms at the location that showed first VAS score decrease of at least 20 mm from baseline score (t= 0 min) to the next assessment time-point). Assessment time-points were taken on pre-scheduled time-points after drug administration: baseline (0 minutes), 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 48 hours. Time to beginning of relief has been calculated as median time, by using the exact time-points on which each assessment was performed."|up to 48 hours after study drug administration|"The full analysis set (FAS or mITT) was defined as the set of patients who provided Informed Consent, were randomized and took at least one dose of the study drug administration."||minutes||Full Range|Median
716871|NCT00262314|Primary|Symptomatic CHF, Left Ventricular Ejection Fraction - Prior to Each Dose • Serious Infections, IV Antibiotics, or Assoc w/ Severe Neutropenia-evaluated. Novantrone Admin - Per PI • SAE, Clinical Relapses|Outcomes are presented separately above apart from adverse events which are presented in the adverse event section|up to 5 years||||||
716872|NCT00262314|Primary|Clinical Relapses (Annual Follow-Up Phase)|Number of clinical relapses reported during the annual follow-up phase of the trial|up to 5 years|participants with annual follow up data||number of relapses|||Number
716873|NCT00262314|Primary|Clinical Relapses (Treatment Phase)|Number of clinical relapses reported during the treatment phase of the trial|up to 36 months|||number of relapses|||Number
716874|NCT00262314|Primary|Severe Neutropenia (Annual Follow-Up Phase)|Number of infections associated with severe neutropenia at onset during the annual follow-up phase|up to 5 years|participants with annual follow up data||number of infections|||Number
716875|NCT00262314|Primary|Severe Neutropenia (Treatment Phase)|Number of infections associated with severe neutropenia at onset during the treatment phase|up to 36 months|||number of infections|||Number
716876|NCT00262314|Primary|IV Antibiotics (Individual Drugs Unspecified) Utilized Due To Serious Infection (Annual Follow-Up Phase)|Number of subjects in whom IV antibiotics were utilized due to serious infection during the annual follow-up phase|up to 5 years|participants with annual follow up data||participants|||Number
716877|NCT00262314|Primary|IV Antibiotics (Individual Drugs Unspecified) Utilized Due to Serious Infection (Treatment Phase)|Number of subjects in whom IV antibiotics were utilized due to serious infection during the treatment phase|up to 36 months|||participants|||Number
716878|NCT00262314|Primary|Serious Infections (Annual Follow-Up Phase)|Number of serious infections during the annual follow-up phase of the trial|up to 5 years|participants with annual follow up data||number of infections|||Number
716879|NCT00262314|Primary|Serious Infections (Treatment Phase)|Number of serious infections during the treatment phase of the trial|up to 36 months|||number of infections|||Number
716880|NCT00262314|Primary|Left Ventricular Ejection Fraction (Annual Follow-Up Phase)|Number of patients with left ventricular ejection fraction test results that decreased below 50% during the annual follow-up phase of the trial|up to 5 years|participants with annual follow up data||participants|||Number
716881|NCT00262314|Primary|Left Ventricular Ejection Fraction (Treatment Phase)|Number of patients with left ventricular ejection fraction test results that decreased below 50% during the treatment phase of the trial|up to 36 months|||participants|||Number
716882|NCT00262314|Primary|Congestive Heart Failure (Annual Follow-Up Phase)|Number of patients experiencing congestive heart failure during the annual follow-up phase of the trial|up to 5 years|participants with annual follow up data||participants|||Number
716883|NCT00262314|Primary|Congestive Heart Failure (Treatment Phase)|Number of patients experiencing congestive heart failure during the treatment phase of the trial|up to 36 months|||participants|||Number
716884|NCT00262509|Primary|Time to Exit Building|Subjects are walked into a building to a specific location and then asked to find their way out of the building. Time to Exit Building is measured. This is protocol is performed twice, and the times averaged to obtain the outcome measure.|30 minutes total, 15 minutes for each of two timed trials|Total number of participants completing study||seconds|Participants|Standard Deviation|Mean
716885|NCT00262522|Secondary|Mean Change From Baseline to Week 96 in CD4+ T Cell Counts||Week 96 (End of Study)|All randomized subjects who received at least 1 dose of study drug and who had CD4+ T cell counts available at both the Baseline Visit and Week 96.||cells/microliter||Standard Error|Mean
716886|NCT00262522|Secondary|Percentage of Subjects With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 50 Copies/mL at Week 96||Week 96 (End of Study)|Intent-to-treat noncompleters considered failures (ITT, NC=F); all randomized subjects who received at least 1 dose of study drug.||Percentage of Subjects|||Number
716887|NCT00262522|Primary|Percentage of Subjects With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 50 Copies/mL at Week 48||Week 48|Intent-to-treat noncompleters considered failures (ITT, NC=F); all randomized subjects who received at least 1 dose of study drug.||Percentage of Subjects|||Number
716890|NCT00262600|Secondary|Clinical Relevant Abnormalities for Intracerebral Hemorrhage and Other Intracranial Hemorrhage (ICH)|Patients with clinical relevant abnormalities for intracerebral hemorrhage, other intracranial hemorrhage (ICH)|36 months|Randomized set - The randomized set includes all randomized subjects in the treatment groups to which they were randomized, regardless of whether the subjects took randomized study medication or not.||yearly event rate (percentage)]|||Number
716891|NCT00262600|Secondary|Bleeding Events (Major and Minor)|"Yearly event rate of bleeds. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum(date of study termination - date of randomization + 1) of all randomized subjects / 365.25
Major bleeds are adjudicated, whereas minor bleeds are investigator reported."|36 months|Randomized set - The randomized set includes all randomized subjects in the treatment groups to which they were randomized, regardless of whether the subjects took randomized study medication or not.||yearly event rate (percentage)|||Number
716892|NCT00262600|Secondary|Yearly Event Rate: Composite of Stroke/SEE/PE/MI/Vascular Death|Time to first occurrence of stroke, systemic embolic event, pulmonary embolism, myocardial infarction including silent myocardial infarction or vascular death. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum(date of study termination - date of randomization + 1) of all randomized subjects / 365.25|36 months|Randomized set - The randomized set includes all randomized subjects in the treatment groups to which they were randomized, regardless of whether the subjects took randomized study medication or not.||yearly event rate (percentage)|||Number
716893|NCT00262600|Secondary|Yearly Event Rate for Composite Endpoint of Stroke/SEE/All Cause Death|Time to first occurrence of stroke, SEE or all cause death. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum(date of study termination - date of randomization + 1) of all randomized subjects / 365.25|36 months|Randomized set - The randomized set includes all randomized subjects in the treatment groups to which they were randomized, regardless of whether the subjects took randomized study medication or not.||yearly event rate (percentage)|||Number
716894|NCT00262600|Primary|Yearly Event Rate for Composite Endpoint of Stroke/SEE|Time to first occurrence of stroke or systemic embolic event. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum(date of study termination - date of randomization + 1) of all randomized subjects / 365.25|36 months|Randomized set - The randomized set includes all randomized subjects in the treatment groups to which they were randomized, regardless of whether the subjects took randomized study medication or not.||yearly event rate (percentage)|||Number
716895|NCT00262639|Secondary|Regional Brain Activity on fMRI||Week 2||||||
716896|NCT00262639|Secondary|Acoustic Startle Response||Day 1, Day 3, Week 1||||||
716897|NCT00262639|Secondary|Sleep||Weeks 1 to 6, 10 and 14||||||
716898|NCT00262639|Primary|Percent Days Abstinent|percent days abstinent during treatment|Weeks 1 to 6, 10 and 14|||percent days||Standard Deviation|Mean
716899|NCT00262639|Primary|Alcohol Withdrawal Scores (CIWAar)||Day 1 Day 2 Week 1||||||
716900|NCT00262639|Primary|Percent Subjects Completely Abstinent|percent of subects completely abstinent during the study|16 week trial|||percent of participants|||Number
716901|NCT00262730|Primary|Survival|survival time is defined from time of histological diagnosis to death occurrence.|30 months|all patients who were treated were analyzed (intent to treat)||months||95% Confidence Interval|Mean
716902|NCT00262743|Other Pre-specified|24 Month Treatment Free Survival Rate|Percentage of participants who were alive and treatment (for progressive CLL) free at 24 months. The 24 month treatment free survival, with 95% CI, was estimated using the Kaplan-Meier method.|24 months (from registration)|Phase II participants who satisfied all eligibility criteria, signed the consent form and started therapy were evaluated for this endpoint.||percentage of participants||95% Confidence Interval|Number
716903|NCT00262743|Secondary|Number of Participants With a Confirmed Complete Response (CR)|A confirmed complete response is a CR which is reported on 2 consecutive cycles at least 4 weeks apart. CR is defined in Primary Outcome Measure #1.|6 months|Phase II participants who satisfied all eligibility criteria, signed the consent form and started therapy were evaluated for this endpoint.||participants|||Number
716904|NCT00262743|Primary|Number of Participants With Biological Response (Bio-R) on 2 Consecutive Evaluations at Least 4 Weeks Apart|Bio-R: A reduction in the absolute lymphocyte count (ALC) of more than 20% from the pretreatment level for at least 2 months or a >= 30% reduction in all palpable lymphadenopathy without meeting the NCIWG criteria for PR was required|6 months|Phase II participants who satisfied all eligibility criteria, signed the consent form and started therapy were evaluated for this endpoint.||participants|||Number
716905|NCT00262743|Primary|Number of Participants With a Confirmed Response [Complete Response (CR) and Partial Response (PR)] on 2 Consecutive Evaluations at Least 4 Weeks Apart|"National Cancer Institute working group criteria (NCIWG) was used to assess response.
CR: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count; confirmed by bone marrow (BM) aspirate & biopsy
PR: 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence/absence of constitutional symptoms; plus ≥1 of the following: ≥1500/μL polymorphonuclear leukocytes, >100000/μL platelets, >11.0 g/dL hemoglobin or 50% improvement for these parameters without transfusions"|6 months|Phase II participants who satisfied all eligibility criteria, signed the consent form and started therapy were evaluated for this endpoint.||participants|||Number
716906|NCT00262821|Secondary|Adverse Events (Grade 3 or Higher) During Treatment Period|Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v3.0.|All Adverse Events (AEs) occuring during treatment and up to 30 days after stopping the study treatment are reported|All Treated Patients||participants|||Number
716907|NCT00262821|Secondary|Overall Survival|The observed length of life from entry into the study to death or date of last contact.|From study entry to death or last contact, up to 6 years|Eligible and evaluable patients||percentage of patients alive|||Number
716908|NCT00262821|Primary|Progression-free Survival - Percentage of Patients Alive and Progression Free|Patients’ progression status based on clinical, radiological or pathological (histological) evidence of disease after study therapy. Progression includes any death without evidence of disease progression. Progression-free Survival (PFS) is defined as time in month from study enrollment to disease progression, death or date of last contact.|From study entry until first disease progression, death or date of last contact, up to 6 years|Eligible and evaluable patients||percentage of patients|||Number
716909|NCT00262834|Primary|Change in Tissue Apoptosis After 3 Days of Treatment|Change in cleaved caspase-3 (a marker of tissue apoptosis) by IHC compared to baseline in the treated (19 evaluable samples) or untreated patients (12 evaluable samples) were analyzed between groups. Cleaved caspase-3 is a protein in cells involved in apoptosis (cell death).|Baseline and after 3 day of vorinostat|Matched samples (ie, diagnostic biopsy and surgical tissues) for cleaved caspase-3 by IHC were available from 19 (71%) treated and from 12 (48%) controls.||percentage of change|Participants|Full Range|Mean
716910|NCT00262834|Secondary|Change in Blood (Peripheral Blood Mononuclear Cells) Histone Acetylation After 3 Days of Treatment||Baseline and after 3 day of Vorinostat||||||
716911|NCT00262834|Secondary|Change in Tissue Histone Acetylation After 3 Days of Treatment||Baseline and after 3 day of Vorinostat||||||
716912|NCT00262834|Primary|Change in Tissue Proliferation After 3 Days of Treatment|Change in Ki-67 (a marker of tissue proliferation) by IHC compared to baseline in the treated (22 evaluable samples) or untreated patients (15 evaluable samples) were analyzed between groups. Ki-67 is a protein in cells that increases as cellsprepare to divide into new cells. A staining process can measure the percentage of tumor cells that are positive for Ki-67. The more positive cells there are, the more quickly they are dividing and forming new cells.|After 3 days of vorinostat|Matched samples (ie, diagnostic biopsy and surgical tissues) for Ki-67 by IHC were available from 22 (92%) treated and from 15 (60%) controls.||percentage of change|Participants|Full Range|Mean
716913|NCT00262834|Primary|Number of Participants With Adverse Events|Participants were evaluated for adverse events due to vorinostat to assess if it was safe to give the drug prior to surgery. 17 of 25 participants who received vorinostat experienced at least 1 adverse event believed to be related to the study drug; no adverse events were severe, and the treatment was considered safe.|After 3 days of vorinostat|Participants who received at least one dose of vorinostat.||participants|||Number
716914|NCT00262847|Secondary|Impact on Quality of Life Measured by the Functional Assessment of Cancer Therapy-Ovary Trial Outcome Index (FACT-O TOI)|Estimated least squares means from a mixed module of Quality of Life (QOL) scores at each assessment point, adjusted for baseline score and patient's age. Note: The range of possible scores of the FACT-O TOI is 0 - 104 for all treatment groups and at all visits. A higher score indicates better QOL. Baseline mean scores are raw means.|At baseline, 9, 18, 36, 60, and 84 weeks|Number of valid QOL assessments do not total number of patients randomized in study.||units on a scale||Standard Deviation|Least Squares Mean
716915|NCT00262847|Secondary|Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0||Up to 5 years||||||
716916|NCT00262847|Secondary|Overall Survival|Median overall survival (OS)|From study entry to death or last contact, up to 6 years|||months||95% Confidence Interval|Median
716917|NCT00262847|Primary|Progression-free Survival|Median progression-free survival (PFS). Onset of progression could be based on radiographic (RECIST) criteria or rising CA-125 (GCIG criteria).|From study entry until first disease progression, death or date of last contact, up to 6 years|||months||95% Confidence Interval|Median
716918|NCT00262860|Secondary|Change in Proteasome Activity Compared to Baseline (Cycle 2)|Peripheral blood (40 ml) was collected at baseline and 1-2 weeks after cycle 2, day 11 post-bortezomib treatment. The samples were refrigerated at 4C and processed within 36 h of collection. Frozen cell lysates were thawed and the proteasome activity in 10 microliters was determined using a spectroflourometric 20S proteasome assay kit. Samples were run in triplicate on two separate days. The percent change between baseline and 2 hrs (day1, cycle 1) was calculated.|baseline and 1-2 weeks after cycle 2, day 11|Samples were not collected on one patient, so only 17 patients were analyzed.||percentage of change in proteosome activ||Full Range|Median
716919|NCT00262860|Secondary|Change in Proteasome Activity Compared to Baseline (Cycle 1)|Peripheral blood (40 ml) was collected on cycle 1, day 1 of prebortezomib at baseline and 2 hrs post-bortezomib treatment. The samples were refrigerated at 4C and processed within 36 h of collection. Frozen cell lysates were thawed and the proteasome activity in 10 microliters was determined using a spectroflourometric 20S proteasome assay kit. Samples were run in triplicate on two separate days. The percent change between baseline and 2 hrs (day1, cycle 1) was calculated.|baseline to 2 hours|Samples were not collected on one patient, so only 17 patients were analyzed.||Percentage of change in proteosome activ||Full Range|Median
716920|NCT00262860|Primary|Response Rate After 2 Courses of Therapy|Response was evaluated after two cycles of therapy using the 1999 Cheson response criteria. All responses were based on CT scans. The criteria that were developed include anatomic definitions of response, with normal lymph node size after treatment of 1.5 cm in the longest transverse diameter by computer-assisted tomography scan. A designation of complete response/unconfirmed was adopted to include patients with a greater than 75% reduction in tumor size after therapy but with a residual mass, to include patients-especially those with large-cell NHL-who may not have residual disease. For patients who had FDG–PET imaging, metabolic response was defined as a decrease in the standardized uptake value in target lesions (regions of abnormal FDG uptake on pretreatment FDG–PET images) to below three on posttreatment FDG–PET imaging). All PET scans were reviewed and interpreted by a single radiologist (SV).|21 Days/course for up to 2 courses|||participants|||Number
716921|NCT00262873|Secondary|Average Number of Leukemia Forming Units in Bone Marrow|Colony forming unit-granulocyte-macrophage (CFU-GM) progenitors, erythroid burst forming units (BFU-E), and leukemia colony forming units (CFU-L) were measured at day 0 and day 14 of cycle 1. Five × 10(4) light density cell for granulocyte-macrophage colony forming unit (CFU-GM) or erythroid burst forming unit (BFU-E) assays were plated in 0.9% methylcellulose, 30% FCS, 2 mmol/L L-glutamine, 10−4 mol/L β-mercaptoethanol, and 1% BSA with 3U/ml human erythropoietin, 10 ng/ml GM-CSF, 10 ng/ml IL-3, and 50 ng/ml stem cell factor (SCF) (c-kit ligand). For leukemia colony forming units (CFU-Ls), the plating mixture was comparable with the exception that the cytokines utilized were 4 U/ml erythropoietin, 10 ng/ml GM-CSF, 10 ng/ml IL-3, 100 ng/ml c-kit ligand, and 100 ng/ml Flt3 ligand. The methylcellulose mixture and associated reagents were purchased from Stem Cell Technologies (Vancouver, BC). Colonies were scored at Day 14 and were defined as > 20 grouped cells.|day 14|baseline bone marrow was only available on 5 participants||number of colonies per 50000 cell plated||Standard Deviation|Mean
717018|NCT00263666|Secondary|Serum Rotavirus Immunoglobulin A (IgA) Antibody Concentrations.|Concentrations are given as geometric mean concentrations (GMC) for anti-rotavirus IgA antibodies.|Two months after dose 3|"The analysis was performed on the According To Protocol Cohort for immunogenicity for whom data were available.
In the placebo group, GMCs were all < 20 U/ml, hence values were not computed."||Units/milliliter||95% Confidence Interval|Geometric Mean
716922|NCT00262873|Secondary|Average Number of Erthroid Burst Forming Units in Bone Marrow|Colony forming unit-granulocyte-macrophage (CFU-GM) progenitors, erythroid burst forming units (BFU-E), and leukemia colony forming units (CFU-L) were measured at day 0 and day 14 of cycle 1. Five × 10(4) light density cell for granulocyte-macrophage colony forming unit (CFU-GM) or erythroid burst forming unit (BFU-E) assays were plated in 0.9% methylcellulose, 30% FCS, 2 mmol/L L-glutamine, 10−4 mol/L β-mercaptoethanol, and 1% BSA with 3U/ml human erythropoietin, 10 ng/ml GM-CSF, 10 ng/ml IL-3, and 50 ng/ml stem cell factor (SCF) (c-kit ligand). For leukemia colony forming units (CFU-Ls), the plating mixture was comparable with the exception that the cytokines utilized were 4 U/ml erythropoietin, 10 ng/ml GM-CSF, 10 ng/ml IL-3, 100 ng/ml c-kit ligand, and 100 ng/ml Flt3 ligand. The methylcellulose mixture and associated reagents were purchased from Stem Cell Technologies (Vancouver, BC). Colonies were scored at Day 14 and were defined as > 20 grouped cells.|day 14|analysis was performed on only four participants||number of colonies per 50000 cell plated||Standard Deviation|Mean
716923|NCT00262873|Secondary|Average Number of Colony Forming Unit-granulocyte-macrophages in Bone Marrow|Colony forming unit-granulocyte-macrophage (CFU-GM) progenitors, erythroid burst forming units (BFU-E), and leukemia colony forming units (CFU-L) were measured at day 0 and day 14 of cycle 1. Five × 10(4) light density cell for granulocyte-macrophage colony forming unit (CFU-GM) or erythroid burst forming unit (BFU-E) assays were plated in 0.9% methylcellulose, 30% FCS, 2 mmol/L L-glutamine, 10−4 mol/L β-mercaptoethanol, and 1% BSA with 3U/ml human erythropoietin, 10 ng/ml GM-CSF, 10 ng/ml IL-3, and 50 ng/ml stem cell factor (SCF) (c-kit ligand). For leukemia colony forming units (CFU-Ls), the plating mixture was comparable with the exception that the cytokines utilized were 4 U/ml erythropoietin, 10 ng/ml GM-CSF, 10 ng/ml IL-3, 100 ng/ml c-kit ligand, and 100 ng/ml Flt3 ligand. The methylcellulose mixture and associated reagents were purchased from Stem Cell Technologies (Vancouver, BC). Colonies were scored at Day 14 and were defined as > 20 grouped cells.|day 14|baseline marrow samples were available only 5 participants||number of colonies per 50000 cell plated||Standard Deviation|Mean
716924|NCT00262873|Secondary|Average Percentage of Light Density Cells in Apoptosis|The CD34+ fraction of light density marrow obtained from patients at baseline and while receiving bortezomib were assessed through measurement of Annexin V (assay obtained form R&D Systems) and by flow cytometry analysis.|day 14|marrow samples were not available on all participants at baseline||percentage of apoptotic cells||Standard Deviation|Mean
716925|NCT00262873|Secondary|Vascular Endothelial Growth Factor (VEGF) Levels in Serum|VEGF levels were measured by ELISA (R&DSystems) in serum from participants exposed to bortezomib. Levels were measured at Day 0 and Day 14 of cycle 1 of the clinical trial.|day 14|data was only available on 5 participants||pg/ml||Standard Deviation|Mean
716926|NCT00262873|Secondary|Interleukin 6 Levels in Serum|"interleukin-6 levels were measured by enzyme-linked immunosorbant assay ELISA in serum from participants exposed to bortezomib.
Levels were measured at Day 0 and Day 14 of cycle 1 of the clinical trial."|day 14|data was only available on 5 participants||pg/ml||Standard Deviation|Mean
716927|NCT00262873|Primary|Number of Participants Who Experienced Cytopenias||21 Days/course for up to 12 courses|This data was not collected.|||||
716928|NCT00262873|Primary|Number of Participants Who Experienced an Adverse Event||For 21 days/course for up to 12 courses|patients enrolled to receive study drug||participants|||Number
716929|NCT00262925|Secondary|Overall Survival|Time from registration to death from any cause. Patients alive were censored at follow up.|assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry|||months||95% Confidence Interval|Median
716930|NCT00262925|Primary|Complete Response Rate|"Complete response requires that all of the following be present for at least four weeks.
1. Peripheral Blood Counts: Neutrophil count >= 1.0 x 109/L, Platelet count >= 100 x 109/L, Reduced hemoglobin concentration or hematocrit has no bearing on remission status, Leukemic blasts must not be present in the peripheral blood.
2 .Bone Marrow Aspirate and Biopsy: Cellularity of bone marrow biopsy must be > 20% with maturation of all cell lines, <= 5% blasts.
3. Extramedullary leukemia, such as CNS or soft tissue involvement, must not be present."|assessed before the first consolidation cycle and first cytoreduction cycle, before the first and after the last maintenance cycle; after discontinuing treatment, assessed every 3 months if < 2 years and every 6 months if 2-5 years from study entry|all enrolled patients||percentage of participants||95% Confidence Interval|Number
716931|NCT00262951|Secondary|Overall Survival|In all patients, measured from the date of the patient’s registration in this study, until the date of the patient’s death or date last known alive (if observation was censored).|Up to 5 Years or Date of Death, Whichever Occurred First|||Months||95% Confidence Interval|Median
716932|NCT00262951|Primary|Number of Patients in Whom Tumor Was Resectable|Tumor response is measured in terms of resectability, as measured by CT scan at 2 weeks after completion of each course. A CT scan of the chest abdomen and pelvis will be performed in order to evaluate for the presence of metastatic disease. If no metastatic disease, emphasis will be paid to the local tumor. Evaluation of the growth/regression of the tumor will be made as it relates to resectability. If potential for resection then surgery will be recommended. This protocol will be followed after each cycle.|Up to 5 Years or Until Disease Progression|||Participants|||Number
716933|NCT00262964|Primary|Change From Baseline in Hepatic Insulin Sensitivity Index|Hepatic insulin sensitivity, assessed as a function of glucose production rate and plasma insulin concentration. The Hepatic Insulin Sensitivity Index (HISI) is measured as the reciprocal of glucose rate of appearance [10000/(μmol/min)] multiplied by insulin concentration[mU/L]. The 10000 in the formula is a conventional adjustment so that insulin sensitivity measures are more readable. As yet there is no normal range for HISI, since is a surrogate marker for hepatic insulin sensitivity that has not yet been validated.|baseline to end of treatment: 8 weeks (fenofibrate), 16 weeks (niacin)|||[10000/(μmol/min)x(mU/L)]||Standard Error|Mean
716934|NCT00262964|Primary|Change From Baseline in Skeletal Muscle Insulin Sensitivity|Changes in skeletal muscle insulin sensitivity (SMIS). SMIS was measured as the increase in skeletal muscle glucose uptake from time zero to the end of a nine hour euglycemic clamp and insulin infusion study. This increase is the percentage change from time zero to end of insulin infusion at nine hours.|baseline to end of treatment: 8 weeks (fenofibrate), 16 weeks (niacin)|||percent increase||Standard Error|Mean
717021|NCT00263666|Secondary|Human Immunodeficiency Virus (HIV) Viral Load|Mean and standard deviation of the base-10 logarithm of HIV-1 ribonucleic acid (RNA) copies per milliliter (mL).|At the screening visit and 2 months after dose 3.|Analysis was performed on the Total Vaccinated Cohort, which included vaccinated subjects for whom data were available.||base-10 logarithm of copies/milliliter||Standard Deviation|Mean
716935|NCT00262964|Primary|Adipose Tissue Insulin Sensitivity in Fenofibrate and Niacin Groups|The baseline and post-treatment measures of adipose tissue insulin sensitivity (ATIS) were compared. ATIS at both timepoints is the suppression from fasting levels of free fatty acid release from adipose tissue (lipolysis) during an insulin infusion as part of a euglycemic clamp study. It is the percent decrease from time zero to the end of the nine hour euglycemic hyperinsulinemic clamp|baseline to post intervention: 8 weeks (fenofibrate), 16 weeks (niacin)|||percent decrease||Standard Error|Mean
716936|NCT00262964|Secondary|Change From Baseline in Very Low-density Lipoprotein Triglyceride Concentration|Change from baseline in very low-density lipoprotein triglyceride concentration (VLDL-Tg)|baseline to end of treatment: 8 weeks (fenofibrate), 16 weeks (niacin)|||mmol/l||Standard Error|Mean
716937|NCT00262964|Secondary|Change From Baseline in VLDL-Tg Production Rate|VLDL-TG production rate, a measure of hepatic secretion of VLDL-triglyceride per liter of plasma per minute.|baseline to end of treatment: 8 weeks (fenofibrate), 16 weeks (niacin)|||(μmol/L/min)||Standard Error|Mean
716938|NCT00262964|Secondary|Change From Baseline in VLDL-Tg Clearance Rate|Very low density lipoprotein triglyceride (VLDL-Tg) clearance rate, a measure of VLDL-triglyceride removal from plasma per minute.|baseline to end of treatment: 8 weeks (fenofibrate), 16 weeks (niacin)|||(ml/min)||Standard Error|Mean
716939|NCT00262964|Secondary|Change From Baseline in Very Low Density Lipoprotein Apolipoprotein B Production Rate|VLDL-apolipoprotein B (apoB) concentrations were measured as part of a VLDL metabolism study utilizing stable isotope tracers. VLDL apoB production rate, a measure of hepatic secretion of VLDL-apolipoproteinB-100 per liter of plasma per minute.|baseline to post intervention: 8 weeks (fenofibrate), 16 weeks (niacin)|||nmol/l/min||Standard Error|Mean
716940|NCT00262964|Primary|Hepatic Fat Content for Fenofibrate and Niacin Groups|Hepatic fat content as measured by magnetic resonance spectroscopy. A PRESS sequence was used. The results from three 10 cubic centimeter voxels positioned within the liver were averaged. The measure is a ratio of triglyceride signal to total signal.|baseline to post intervention: 8 weeks (fenofibrate), 16 weeks (niacin)|10 (or more) subjects in each group would be sufficient for detecting changes in IHTG.||ratio||Standard Deviation|Mean
716941|NCT00262964|Primary|Adipose Tissue Insulin Sensitivity|The ability of insulin to suppress the release of fatty acids from adipose tissue: Adipose tissue insulin sensitivity, measured as the suppression from baseline of free fatty acid release from adipose tissue (lipolysis) during insulin infusion as part of a nine hour euglycemic hyperinsulinemic clamp study.|baseline cross-sectional data pre and post nine hour euglycemic clamp|||percent decrease||Standard Error|Mean
716942|NCT00262964|Primary|Percent Increase in Skeletal Muscle Insulin Sensitivity During Insulin Infusion.|A precise measure of the ability of insulin to stimulate glucose uptake by skeletal muscle. Skeletal muscle insulin sensitivity, measured as the increase from baseline in skeletal muscle glucose uptake during insulin infusion(percentage)as part of a nine hour euglycemic hyperinsulinemic clamp study.|baseline cross-sectional data pre and post nine hour euglycemic clamp|||percent increase||Standard Error|Mean
716943|NCT00262964|Secondary|Very Low Density Lipoprotein - Triglyceride Production Rate|Very low density lipoprotein triglyceride (VLDL-TG) production rate, a measure of hepatic secretion of VLDL-triglyceride per liter of plasma per minute (μmol/L/min).|baseline cross-sectional data|||μmol/L/min||Standard Error|Mean
716944|NCT00262964|Primary|Hepatic Insulin Sensitivity Index (HISI)|Hepatic insulin sensitivity, assessed as a function of glucose production rate and plasma insulin concentration. The Hepatic Insulin Sensitivity Index(HISI) is the reciprocal of glucose rate of appearance [10000/(μmol/min)] multiplied by insulin concentration[mU/L]. The 10000 in the formula is a conventional adjustment so that insulin sensitivity measures are more readable. As yet there is no normal range for HISI, since is a surrogate marker for hepatic insulin sensitivity that has not yet been validated.|baseline cross-sectional data|number of subjects determined by power calculations. Analysis was per protocol. Intrahepatic triglyceride was determined by magnetic resonance spectroscopy.||[10000/(μmol/min)x(mU/L)]||Standard Error|Mean
716945|NCT00263211|Secondary|Progression Free Survival||Maximum of 6 months|This trial was terminated early due to futility, subjects were not followed for progression free-survival.|||||
716946|NCT00263211|Secondary|Clopidogrel-Mediated Percent of Platelet Inhibition vs. Time Plotted for Aspirin and Plavix and Observation Groups|Mean Clopidogrel-Mediated platelet inhibition (% inhibition) vs. time for Aspirin and Plavix and Observation groups|Baseline, 2 weeks and 1 month|Mean Platelet inhibition Denominator for Plavix & Aspirin arm baseline n=22, 2 weeks n=20, 1 month n=19 Denominator for control group baseline n=24 , 2-weeks n=19, 1 month n=23||percentage of platelet inhibition||Standard Deviation|Mean
716947|NCT00263211|Secondary|Mean Aspirin-Mediated Platelet Inhibition vs. Time Plotted for Plavix and Aspirin and Observation Groups|Mean platelet inhibition vs. time plotted for Plavix & Aspirin Arm and Observation group. Citrated whole blood is added to a test carriage containing fibrinogen-coated beads and a platelet activator (arachidonic acid to synthesize thromboxane A2). Using a turbidimetric-based optical detection system, aggregation of activated platelets to fibrinogen-coated beads increase light transmittance which is reported in Aspirin Reaction Units (ARU).|Baseline, 2 weeks and 1 month|Denominator for Plavix & Aspirin arm baseline n=22, 2 weeks n=20, 1 month n=19 Denominator for Observation only arm baseline n=24 , 2-weeks n=19, 1 month n=23||Aspirin Reaction Units||Standard Deviation|Mean
716948|NCT00263211|Secondary|Percentage of Patients With a Given Absolute Number of Circulating Tumor Cells (Broken Into Categories) Plotted Against Time|Percent of patients with a given number/range of CTCs ( 0, 1-5 >+ 5) vs. time baseline 2-weeks and 1 month for plavix & Aspirin arm and observation only|Baseline, 2 weeks and 1 month|Denominator for Plavix & Aspirin arm at Baseline=22, at 2 weeks =20, at 4 weeks =19 Denominator for Observation only at Baseline=24, at 2 weeks=19, at 4 weeks =23||percentage of participants|||Number
716949|NCT00263211|Primary|Safety and Tolerability of Aspirin and Plavix Measured by the Number of Patients Who Discontinue the Study Drug|Measured by number of patients who discontinue administration of study drug because of toxicity and the incidence categorized by type.|Maximum of 6 months|Plavix and Aspirin: 1 patient withdrew consent prior to starting 1 patient died prior to starting||participants|||Number
717019|NCT00263666|Secondary|Number of Subjects With Vaccine Take.|Vaccine take: appearance of serum IgA to rotavirus at a concentration of ≥ 20 U/ml or rotavirus shedding in any stool sample collected from the Screening Visit to 2 months after dose 3 for subjects initially negative for rotavirus.|Two months after the dose 3|Analysis was performed on subjects from the According To Protocol Cohort for immunogenicity for whom data were available||subjects|||Number
716950|NCT00263211|Primary|Platelet Inhibition of Circulating Tumor Cells (CTCs) Measured by the Number of Patients With Detectable CTCs|Measured by number of patients who have detectable circulating tumor cells|Week 4|Plavix & Aspirin arm has 19 evaluable patients. 5 withdrew before 1-month data collection: death n=1 and withdrawal of consent n=1 prior to starting; surgery plans n=1; patient preference n=1; platelet inhibition use n=1; Observation only arm had 23 evaluable patients ; 1 patient withdrew during the first month due to disease progression.||participants|||Number
716951|NCT00263328|Secondary|Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Health Care Resource Utilization (HCRU) Questionnaire|HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any number of events including visits to doctor or other healthcare professionals (HCP), non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.|Months 12, 18, and 24|Safety population; n=number of participants in Safety Population per visit with non-missing value.||events||Standard Deviation|Mean
716952|NCT00263328|Secondary|Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale|"ESRD-SCL: 43-item, disease-specific, self-administered questionnaire. Participants' rated question At the moment, how much do you suffer? for each item on 5-point scale, ranged from 0 (not at all) to 4 (extremely). Consisted of 6 subscales: cardiac and renal dysfunction (Range, 0-28), increased growth of gum and hair (Range, 0-20), limited cognitive capacity (Range, 0-32), limited physical capacity (Range, 0-40), SEs of corticosteroids (Range, 0-20),TAPD (Range, 0-32); higher scores=greater dysfunction for each subscale. Total score: 0-172, higher scores=greater dysfunction."|Baseline, Months 12, 18, and 24|Safety population; n=number of participants in Safety Population per visit with non-missing value.||scores on a scale||Standard Deviation|Mean
716953|NCT00263328|Secondary|End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale|"ESRD-SCL: 43-item, disease-specific, self-administered questionnaire. Participants' rated question At the moment, how much do you suffer? for each item on 5-point scale, ranged from 0 (not at all) to 4 (extremely). Consisted of 6 subscales: cardiac and renal dysfunction (Range, 0-28), increased growth of gum and hair (Range, 0-20), limited cognitive capacity (Range, 0-32), limited physical capacity (Range, 0-40), side effects (SEs) of corticosteroids (Range, 0-20), transplantation associated psychological distress (TAPD; Range, 0-32); higher scores=greater dysfunction for each subscale. Total score: 0-172, higher scores=greater dysfunction."|Months 12, 18, and 24|Safety population; n=number of participants in Safety Population per visit with non-missing value.||scores on a scale||Standard Deviation|Mean
716954|NCT00263328|Secondary|Change From Baseline in SF-36 v2 Subscale Scores by Visit|"SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as PCS and MCS. Total of 11 variables were analyzed (8 subscales, 2 composite subscales and Question 2 how would you rate your health in general now? (range 1= better, 5= worst). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Negative change from baseline represented improvement."|Baseline, Months 12, 18, and 24|Safety population; n=number of participants in Safety Population per visit with non-missing value.||scores on a scale||Standard Deviation|Mean
716955|NCT00263328|Secondary|SF-36 v2 Subscale Scores by Visit|"SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as PCS and MCS. Total of 11 variables were analyzed (8 subscales, 2 composite subscales and Question 2 how would you rate your health in general now? (range 1= better, 5= worst). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning)."|Months 12, 18, and 24|Safety population; n=number of participants in Safety Population per visit with non-missing value.||scores on a scale||Standard Deviation|Mean
716956|NCT00263328|Secondary|Change From Baseline in SF-36 v2 MCS and PCS Scores by Visit and Scale|"SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as PCS and MCS. Total of 11 variables were analyzed (8 subscales, 2 composite subscales and Question 2 how would you rate your health in general now? (range 1= better, 5= worst). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Negative change from baseline represented improvement."|Baseline, Months 12, 18, and 24|Safety population; n=number of participants in Safety population per visit with non-missing value.||scores on a scale||Standard Deviation|Mean
716957|NCT00263328|Secondary|Short-Form 36 Version 2 (SF-36 v2) Mental Component Summary (MCS) and Physical Component Summary (PCS) Scores by Visit and Scale|"The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, 36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical and mental component scores (PCS and MCS). Total of 11 variables were analyzed (8 subscales, 2 composite subscales and Question 2 how would you rate your health in general now? (range 1= better, 5= worst). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning)."|Months 12, 18, and 24|Safety population; n=number of participants in Safety Population per visit with non-missing value.||score on a scale||Standard Deviation|Mean
716958|NCT00263328|Secondary|Trough Levels of Tacrolimus (ng/mL) by Visit||Months 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, and 72 and Follow-up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.||ng/mL||Standard Deviation|Mean
716959|NCT00263328|Secondary|Tofacitinib Concentrations in Plasma (ng/mL) by Visit||Months 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.||ng/mL||Standard Deviation|Mean
716960|NCT00263328|Secondary|Fasting Serum Glucose Levels (mg/dL) by Visit||Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.||mg/dL||Standard Deviation|Mean
716961|NCT00263328|Secondary|HOMA Insulin Resistance (IR) by Visit|HOMA-IR=fasting serum insulin*fasting serum glucose/22.5. Measurement only performed in participants who were non-diabetic prior to kidney transplantation and who do not require treatment with oral hypoglycemic agents, anti diabetic agents, and/or insulin prior to the time of measurement.|Months 12 and 24|Safety population; n=number of participants who were eligible for OGTT and had data (non-mising) at that particular visit.||HOMA-IR||Standard Deviation|Mean
716962|NCT00263328|Secondary|AUC of Serum Insulin (microU*h/mL) Measured During OGTT by Visit|The OGTT was performed only in participants who were non-diabetic prior to kidney transplantation and who did not require treatment with oral hypoglycemic agents, anti-diabetic agents, and/or insulin.|Months 12 and 24|Safety population: n=number of participants who were eligible for OGTT and had data (non-mising) at that particular visit.||microU*h/mL||Standard Deviation|Mean
716963|NCT00263328|Secondary|Area Under the Curve (AUC) of Serum Glucose (mg*h/dL) Measured During Oral Glucose Tolerance Test (OGTT) by Visit|Only performed in participants who were non-diabetic prior to kidney transplantation and who did not require treatment with oral hypoglycemic agents, anti-diabetic agents, and/or insulin.|Months 12 and 24|Safety population; n=number of participants eligible for OGTT with data (non-missing) at that particular visit.||mg*h/dL||Standard Deviation|Mean
716964|NCT00263328|Secondary|Ratio of Fasting Serum Proinsulin (Pmol/L) to Insulin (Pmol/L) by Visit|Measured only in participants who were non-diabetic prior to kidney transplantation and who did not require treatment with oral hypoglycemic agents, anti-diabetic agents, and/or insulin prior to the time of measurement.|Months 12 and 24|Safety population; n=number of participants eligible for OGTT and had data (non-missing) at that particular visit.||ratio of serum proinsulin to insulin||Standard Deviation|Mean
716965|NCT00263328|Secondary|Homeostatic Model Assessment (HOMA)-%B by Visit|HOMA-%B = (20 times [*] fasting serum insulin) divided by (/) (fasting serum glucose minus [-] 3.5). HOMA-%B was only performed in participants who were non-diabetic prior to kidney transplantation and who did not require treatment with oral hypoglycemic agents, anti-diabetic agents, and/or insulin prior to the time of measurements.|Months 12 and 24|Safety population; n=number of participants who were eligible for OGTT and had data (non-missing) at that particular visit.||%B||Standard Deviation|Mean
716966|NCT00263328|Secondary|Hemoglobin A1c (HbA1c) Levels by Visit||Months 12, 24, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96 and Follow-up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.||% HbA1c||Standard Deviation|Mean
716967|NCT00263328|Secondary|Absolute Cluster of Differentiation (CD) 8+, CD19+, CD4+, and CD56+ Flouresence Activated Cell Sorting (FACS) Counts (Cells/uL) by Visit||Months 12 and 24|Safety population||cells/uL||Standard Deviation|Mean
716968|NCT00263328|Secondary|Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit|Kaplan-Meier analysis of percentage of participants with rejection by time to rejection within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. Rejection was defined as first occurrence of BPAR, antibody-mediated rejection or suspicious for acute rejection. This included biopsies read by the central pathologist.|Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96|FAS; n=number of participants remaining at risk for the specified parameter at a given visit.||percentage of participants|||Number
716969|NCT00263328|Secondary|Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit|Kaplan-Meier analysis of percentage of participants surviving by time to event (death) within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier.|Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96|FAS; n=number of participants remaining at risk for the specified parameter at a given visit.||percentage of participants|||Number
716970|NCT00263328|Secondary|Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit|Kaplan-Meier analysis of percentage of participants with graft survival by time to graft loss within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. Graft loss was defined as graft nephrectomy, retransplantation, return to dialysis for â‰¥6 consecutive weeks, or death.|Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96|FAS; n=number of participants remaining at risk for the specified parameter at a given visit.||percentage of participants|||Number
716971|NCT00263328|Secondary|Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit|Kaplan-Meier analysis of percentage of participants with efficacy failure by time to first efficacy failure within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. Efficacy failure was defined as first occurrence of BPAR, death, or graft loss.|Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96|FAS; n=number of participants remaining at risk for the specified parameter at a given visit.||percentage of participants|||Number
716972|NCT00263328|Secondary|Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN|Ordered categorical severity of first BPCAN was classified according to the Banff Classification. Grade I: mild, grade II: moderate and grade III: severe interstitial fibrosis and tubular atrophy/loss. (Racusen et al: The Banff classification, 1999).|Months 12, 18, 24, 36, 48, 60, 72, 84, and 96|FAS||percentage of participants|||Number
716973|NCT00263328|Secondary|Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR|Antibody-mediated rejection is defined as Category 2 and BPAR is defined as Category 4 of the Banff Classification, based on the assessment of the renal allograft biopsy by a central, blinded pathologist. Acute humoral rejection was categorized as Grades I, II, III and acute/active cellular rejection was categorized as Grades IA, IB, IIA, IIB, and III. Only participants with first BPAR were included.|Months 12, 18, 24, 36, 48, 60, 72, 84, 96, and Follow-Up (Month 98)|FAS||percentage of participants|||Number
721299|NCT00307047|Secondary|Ischemia Driven Target Vessel Failure (TVF)|Defined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR|30 days|||percentage of participants|||Number
716974|NCT00263328|Secondary|Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit|Kaplan-Meier analysis of percentage of participants with first BPCAN by time to first BPCAN within 96 months post-transplant. BPCAN was defined as chronic allograft nephropathy (Category 5 of the Banff Classification), based on the assessment of the renal allograft biopsy by a central, blinded pathologist. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. Includes BPCAN diagnosed on biopsies done for cause and ready by the central pathologist.|Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96|FAS; n=number of participants remaining at risk for the specified parameter at a given visit.||percentage of participants|||Number
716975|NCT00263328|Secondary|Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit|Kaplan-Meier analysis of percentage of participants with CMV disease within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. CMV disease was an adverse event associated with the preferred term 'CMV infection'.|Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96|Safety population; n=number of participants remaining at risk for the specified parameter at a given visit.||percentage of participants|||Number
716976|NCT00263328|Secondary|Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit|Cutoff categories for BKV DNA were 0-199 and ≥200 copies/PCR. Per protocol, BKV DNA PCR was performed on tofacitinib-treated participants only.|Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
716977|NCT00263328|Secondary|BK Virus (BKV) DNA Levels Determined Using PCR by Visit|Calculated as number of copies per PCR. Per protocol, BKV DNA PCR was performed on tofacitinib-treated participants only.|Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.||number of copies/PCR||Standard Deviation|Mean
716978|NCT00263328|Secondary|Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit|EBV DNA PCR categories included 0, 1-50, 51-100, 101-1000, and >1000 copies/PCR.|Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96 and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
716979|NCT00263328|Secondary|Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit|Calculated as number of copies per 500 mg DNA.|Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96|Safety population; n=number of participants assessed for the specified parameter at a given visit.||number of copies/500 mg DNA||Standard Deviation|Mean
716980|NCT00263328|Secondary|Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit||Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96|Safety population; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
716981|NCT00263328|Secondary|Percentage of Participants Requiring Anti-Hypertensive Medication by Visit||Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96|Safety population; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
716982|NCT00263328|Secondary|Percentage of Participants Requiring Lipid-Lowering Agents by Visit||Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96|Safety population; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
716983|NCT00263328|Secondary|Serum Triglyceride Levels by Visit||Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.||mg/dL||Standard Deviation|Mean
716984|NCT00263328|Secondary|Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit||Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
716985|NCT00263328|Secondary|Ratio of Serum LDL Level to HDL Level by Visit||Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.||ratio||Standard Deviation|Mean
716986|NCT00263328|Secondary|Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit||Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
716987|NCT00263328|Secondary|Ratio of Total Serum Cholesterol Level to HDL Level by Visit||Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.||ratio||Standard Deviation|Mean
716988|NCT00263328|Secondary|High-Density Lipoprotein (HDL) Levels by Visit||Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.||mg/dL||Standard Deviation|Mean
716989|NCT00263328|Secondary|Low-Density Lipoprotein (LDL) Levels by Visit||Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.||mg/dL||Standard Deviation|Mean
716990|NCT00263328|Secondary|Total Cholesterol Levels by Visit||Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.||mg/dL||Standard Deviation|Mean
717035|NCT00270257|Secondary|Number of Participants With Urinalysis Results Positive for Opiates|Urine drug screen were assessed monthly and semiannually.|Measured through Week 104|Number of participants presented here applies to visit 104 for whom data available.||participants|||Number
716991|NCT00263328|Secondary|Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit|Kaplan-Meier analysis of percentage of participants with NODM-2 by time to NODM-2 within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. NODM-2 was defined as an event experienced by a transplanted subject who meets any of the following criteria: (a) NODM-1; or (b) Symptoms of diabetes plus 2 casual serum glucose levels â‰¥200 mg/dL separated by at least approximately 24 hours. Casual was defined as any time of day without regard to time since last meal; or (c) Fasting serum glucose â‰¥126 mg/dL on 2 different occasions separated by at least approximately 24 hours. Fasting was defined as no caloric intake for at least 8 hours; or (d) 2-hour serum glucose â‰¥200 mg/dL during an OGTT (Oral Glucose Tolerance Test).|Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96|Safety population; n=number of participants remaining at risk for the specified parameter at a given visit. Participants who had a history of diabetes at transplant were not included in the Kaplan-Meier analysis.||percentage of participants|||Number
716992|NCT00263328|Secondary|Reciprocal of Serum Creatinine||Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.||dL/mg||Standard Deviation|Mean
716993|NCT00263328|Secondary|Calculated GFR Using Cockcroft-Gault Equation (mL/Min)|GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was calculated using Cockcroft-Gault equation. GFR by Cockcroft-Gault equation= body weight (kg)*(140 minus age in years) divided by (72*serum creatinine [mg/dL]). For females value obtained was multiplied by 0.85. A normal GFR is >90 mL/min, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR <15 mL/min indicated kidney failure.|Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.||mL/min||Standard Deviation|Mean
716994|NCT00263328|Secondary|Calculated GFR Using the Nankivell Equation (mL/Min)|GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR was estimated by creatinine clearance (CLcr; in mL/min]) using Nankivell equation. CLcr by Nankivell equation= (6.7 per serum creatinine [in millimoles per liter (mmol/L)]) plus (0.25*body weight [in kilograms (kg)]) minus (0.5*serum urea [mmol/dL, where 1 mg/dL BUN=0.36 mmol/L urea]) minus (100 per height [in meters] square) plus (35 for male/25 for female). A normal GFR is >90 mL/min, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR <15 mL/min indicated kidney failure.|Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.||mL/min||Standard Deviation|Mean
716995|NCT00263328|Primary|Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit|Kaplan-Meier analysis of percentage of participants with treatment failure by time to treatment failure within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. Treatment failure was defined as the first occurrence of BPAR, death, graft loss or premature discontinuation of trial medication for any reason.|Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96|Full Analysis Set (FAS): all participants who received at least 1 dose of study medication. n=number of participants remaining at risk for the specified parameter at a given visit.||percentage of participants|||Number
716996|NCT00263328|Primary|Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit|Kaplan-Meier analysis of percentage of participants with first BPAR by time to first BPAR within 96 months post-transplant. BPAR was defined as acute/active cellular rejection (Category 4 of the Banff Classification), based on the assessment of the renal allograft biopsy by a central, blinded pathologist. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier.|Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96|Safety population; n=number of participants remaining at risk for the specified parameter at a given visit.||percentage of participants|||Number
716997|NCT00263328|Primary|Percentage of Participants With Hypertriglyceridemia by Visit|Hypertriglyceridemia was defined as triglyceride levels of >200 mg/dL or 2.3 mmol/L.|Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
716998|NCT00263328|Primary|Percentage of Participants With Hypercholesterolemia|Hypercholesterolemia was defined as cholesterol levels >240 mg/dL or 6.2 mmol/L.|Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
716999|NCT00263328|Primary|Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit|Kaplan-Meier analysis of time to NODM-1 within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. NODM-1 was defined as an event experienced by participants who were non-diabetic prior to transplantation and required treatment with oral hypoglycemic agents, anti-diabetic agents, and/or insulin for greater than or equal to (â‰¥)30 days.|Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96|Safety population; participants who had a history of diabetes at transplant were not included in the Kaplan-Meier analysis. n=number of participants remaining at risk for the specified parameter at a given visit.||percentage of participants|||Number
717020|NCT00263666|Secondary|Number of Subjects Who Seroconverted Against Rotavirus|A subject with anti-rotavirus Immunoglobulin (IgA) antibody concentration < 20 units/milliliter (U/mL) before vaccination and ≥ 20 U/mL after vaccination is considered as seroconverted.|Two months after dose 3|Analysis was performed on subjects from the According to Protocol Cohort for immunogenicity for whom results were available||subjects|||Number
717000|NCT00263328|Primary|Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit|Kaplan-Meier analysis of percentage of participants with clinically significant infections by time to first clinically significant infection within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier.|Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96|Safety population; n=number of participants remaining at risk for the specified parameter at a given visit.||percentage of participants|||Number
717001|NCT00263328|Primary|Serum Creatinine Levels||Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.||mg/dL||Standard Deviation|Mean
717002|NCT00263328|Primary|Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation|GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was calculated using MDRD equation. GFR by MDRD equation = 170 * (serum creatinine [in milligrams per deciliter (mg/dL)])^(-0.999) * (age in years)^(-0.176) * (0.762 if female) * (1.18 if black) * (blood urea nitrogen [BUN] concentration [mg/dL])^(-0.170) * (serum albumin concentration [in grams per dL (g/dL)])^(0.318). A normal GFR is >90 milliliters per minute per 1.73 square meters (mL/min/1.73 m^2), although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR <15 mL/min/1.73 m^2 indicated kidney failure.|Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.||mL/min/1.73 m^2||Standard Deviation|Mean
717003|NCT00263666|Secondary|Number of Subjects With the RV in Stool Samples|Number of subjects with presence of RV in stool samples (shedding) collected at pre-determined time points by RV type (Yes, No, Mixed type and results not available [NA]).|From Dose 1 until post Dose 3|Analysis was performed on subjects from the According to Protocol Cohort for immunogenicity for whom results were available||Subjects|||Number
717004|NCT00263666|Secondary|Enteric Pathogens Identification.|Number of gastroenteritis (GE) episodes classified by enteric pathogen tests results.|From Dose 1 until 2 months after dose 3 or until end of RV shedding|The analysis was performed on the subjects from the Total Vaccinated Cohort with gastroenteritis episodes reported between the first dose and the last visit and for whom stools were collected||number of GE episodes|||Number
717005|NCT00263666|Secondary|Rotavirus Vaccine Strain Identification.|"Number of gastroenteritis (GE) episodes classified by rotavirus vaccine strain/serotype.
Unknown: These samples were typed post hoc and found “G1P8” vaccine type for one subject in HRV group, “G3P8” and “G2P4” for subjects in placebo group."|From dose 1 until 2 months after dose 3 or until end of RV shedding|Analysis was performed on the Total Vaccinated Cohort.||Number of episodes|||Number
717006|NCT00263666|Secondary|Rotavirus in Diarrheal Stool Samples|Number of subjects reporting at least one rotavirus (vaccine strain or wild type rotavirus) gastroenteritis episode.|From Dose 1 until 2 months after dose 3 or until end of RV shedding|Analysis was performed on the Total Vaccinated Cohort||Number of episodes|||Number
717007|NCT00263666|Secondary|Rotavirus Antigen Excretion in Stool Samples|Number of subjects with rotavirus detected by Enzyme Linked Immunosorbent Assay (ELISA) in stool samples collected from Dose 1 until study end|At day of each vaccination and at planned days following each vaccine dose until 2 months after dose 3 or until end of RV shedding|The analysis was performed on the According to Protocol Cohort for immunogenicity.||subjects|||Number
717008|NCT00263666|Secondary|Geometric Mean Titer for Anti-polio Types 1, 2 and 3 Antibodies.||Two months after dose 3|The analysis was performed on the According To Protocol cohort for immunogenicity||titer||95% Confidence Interval|Geometric Mean
717009|NCT00263666|Secondary|Number of Subjects With Anti-polio Types 1, 2 and 3 Antibody Titers More Than or Equal to the Cut-off Value|The cut-off value was ≥ 1:8. The lowest dilution at which serum samples were tested was 1:8, from which a test was considered positive.|Two months after dose 3|The analysis was performed on the According To Protocol cohort for immunogenicity.||subjects|||Number
717010|NCT00263666|Secondary|Geometric Mean Concentration for Anti-BPT Antibodies.||Two months after dose 3|The analysis was performed on the According to Protocol cohort for immunogenicity.||ELISA-Units/milliliter||95% Confidence Interval|Geometric Mean
717011|NCT00263666|Secondary|Number of Subjects With Anti-Bordetella Pertussis (BPT) Antibody Concentrations More Than or Equal to the Cut-off Value|The cut-off value was ≥ 15 Enzyme Linked Immunosorbent Assay Unit/milliliter(EL.U/mL).|Two months after dose 3|The analysis was performed on the According To Protocol cohort for immunogenicity.||subjects|||Number
717012|NCT00263666|Secondary|Geometric Mean Concentration for Anti-HBs Antibodies.||Two months after dose 3|The analysis was performed on the According to Protocol cohort for immunogenicity.||Milli International Units/milliliter||95% Confidence Interval|Geometric Mean
717013|NCT00263666|Secondary|Number of Subjects With Anti-hepatitis B (HBs) Antibody Concentrations More Than or Equal to the Cut-off Value|The cut-off value was ≥ 10 milli international units/milliliter (mIU/mL).|Two months after dose 3|The analysis was performed on the According To Protocol cohort for immunogenicity.||subjects|||Number
717014|NCT00263666|Secondary|Geometric Mean Concentration for Anti-diphtheria and Anti-tetanus Toxoids Antibodies.||Two months after dose 3|The analysis was performed on the According to Protocol cohort for immunogenicity.||International Units / milliliter||95% Confidence Interval|Geometric Mean
717015|NCT00263666|Secondary|Number of Subjects With Anti-diphtheria and Anti-tetanus Toxoids Antibody Concentrations More Than or Equal to the Cut-off Value|The cut-off value was ≥ 0.1 International Units/milliliter (IU/mL)|Two months after dose 3|The analysis was performed on the According To Protocol cohort for immunogenicity.||subjects|||Number
717016|NCT00263666|Secondary|Geometric Mean Concentration for Anti-PRP Antibodies.||Two months after dose 3|The analysis was performed on the According to Protocol cohort for immunogenicity.||microgram/milliliter||95% Confidence Interval|Geometric Mean
717017|NCT00263666|Secondary|Number of Subjects With Anti-polyribosyl Ribitol Phosphate (PRP) Antibody Concentrations More Than or Equal to the Cut-off Value.|Cut-off values for anti-PRP antibody concentrations were ≥ 0.15 and ≥ 1.0 microgram/milliliter (µg/mL).|Two months after dose 3|The analysis was performed on the According To Protocol Cohort for immunogenicity||subjects|||Number
717022|NCT00263666|Secondary|The Number of Subjects With no Evidence of Immunosuppression and Moderate/ Severe Suppression, Based on CD4+ Absolute Cell Count and CD4+ Percent.|Severe suppression: CD4+ cells/microliter (μl) < 750 and CD4+ percent < 15 percent (%); No evidence of suppression: CD4+ cells/μl ≥ 1500 and CD4+ percent ≥ 25%; Moderate suppression = all other CD4+ cell count and CD4+ % combinations.|At the screening visit and 2 months after dose 3 (Visit 4).|Analysis was performed on the Total Vaccinated Cohort, which included vaccinated subjects for whom data were available.||subjects|||Number
717023|NCT00263666|Secondary|Number of Subjects Reporting Each Type of Solicited Symptom.|Solicited symptoms included Cough, Diarrhea (3 or more looser than normal stools/day), Fever (axillary temperature ≥ 37.5°C), Irritability, Loss of appetite, and Vomiting.|Within the 15-day solicited follow-up period after each dose|Analysis was performed on the Total Vaccinated Cohort, which included vaccinated subjects for whom data were available.||subjects|||Number
717024|NCT00263666|Secondary|Number of Subjects Reporting Any Serious Adverse Events.|"A serious adverse event (SAE) is any untoward medical occurrence that:
results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above."|Until 2 months after dose 3 (for subjects RV negative at Day 42 post-dose 3) or until end of RV shedding (for subjects who shed RV at Day 42 post-dose 3).|Analysis was performed on the Total Vaccinated Cohort||subjects|||Number
717025|NCT00263666|Secondary|Number of Subjects Reporting Any Unsolicited Symptoms.|An unsolicited symptom was any spontaneously reported untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Within 30 days after each dose|Analysis was performed on the Total Vaccinated Cohort||subjects|||Number
717026|NCT00263666|Primary|Number of Subjects Reporting Grade “2” or Grade “3” Fever, Vomiting or Diarrhea.|"Symptoms reported in the table include:
Fever: temperature (axillary route) > 38.0 degree Celsius (°C); Diarrhea: ≥ 4 looser than normal stools/day; Vomiting: ≥ 2 episodes of vomiting/day."|Within the 15-day solicited follow-up period after any dose.|The analysis was performed on the Total Vaccinated Cohort which included the vaccinated subjects for whom data were available.||subjects|||Number
717027|NCT00263757|Secondary|Mean Score on Functional Outcomes of Sleep Questionnaire (FOSQ)|The FOSQ is a disease-specific quality of life questionnaire to determine functional status in adults. The measures are designed to assess the impact of disorders of excessive sleepiness on multiple activities of everyday living. There are 30 items on the questionnaire consisting of 5 factor subscales. The subject rates the difficulty of performing a given activity on a 4-point scale (no difficulty to extreme difficulty). A higher score indicates greater difficulty or impact of sleepiness on daily living. FOSQ total score ranges from 0 (no difficulty) to 120 (extreme difficulty).|baseline, 12 months|"Usual Care Arm: At the baseline visit 13 participants completed the FOSQ, and at the 12 month visit 4 participants completed the FOSQ, some due to withdrawals.
Therapeutic Positive Airway Pressure Arm: At the baseline visit 12 participants completed the FOSQ, and at the 12 month visit 4 participants completed the FOSQ, due to withdrawals."||units on a scale||Standard Deviation|Mean
717028|NCT00263757|Secondary|Mean Score on Epworth Sleepiness Scale (ESS) at Baseline and 12 Month Visit|The ESS is a measure of general level of sleepiness. The ESS asks subjects to rate their usual chances of dozing off or falling asleep in 8 different situations or activities that most people engage in as part of their daily live, although not necessarily every day. The questionnaire has 8 questions, with responses ranging from 0 (would never dose) to 3 (high chance of dozing). Therefore the total score could range from 0 (no sleepiness) to 24 (high chance of dozing).|baseline, 12 months|"Usual Care Arm: At the baseline visit 13 participants completed the ESS, and at the 12 month visit 6 participants completed the ESS, due to withdrawals.
Therapeutic Positive Airway Pressure Arm: At the baseline visit 12 participants completed the ESS, and at the 12 month visit 5 participants completed the ESS, due to withdrawals."||units on a scale||Standard Deviation|Mean
717029|NCT00263757|Primary|Number of Subjects Who Had Atrial Fibrillation Recurrence at 1 Year||1 year|||participants|||Number
717030|NCT00270257|Secondary|Incident Hepatitis B Infections|Serum samples were tested at baseline and between 26-52 weeks later for Hepatitis B surface antigen (HBsAg) using a commercial enzyme immunoassay (EIA) (Abbott Murex HBsAg version 3.0). If the HBsAg test was initially non-reactive, then the participant was considered to be negative for HBsAg. If the HBsAg test was initially reactive, then it was repeated in duplicate. If at least two of 3 tests were reactive, then the participant was considered to be positive for HBsAg.|Measured through week 52|||participants with HBsAg|||Number
717031|NCT00270257|Secondary|Incident Hepatitis C Infections for Thailand and China|"HCV antibody using two different HCV EIA assays (Ortho HCV antibody version 3.0 and Wantai HCV antibody assay) at baseline and between 26-156 weeks later.
If both HCV EIA antibody assays were nonreactive, then the participant was considered not to be HCV infected. If either assay was reactive, then the Ortho HCV assay was repeated in duplicate. If two of 3 Ortho HCV assays were reactive, then the participant was considered to be HCV infected. Samples that were repeatedly reactive for HCV antibody at a follow-up visit were tested for HCV RNA by the Roche COBAS® AmpliPrep/COBAS® TaqMan® HCV assay. Not all participants had follow-up testing performed in China due to early closure of the study by the Data Safety Monitoring Board on account of futility due to a low HIV incidence (the primary study endpoint).
Analysis was done separately for both countries"|Measured through week 156 in Thailand and 104 weeks in China|Baseline HCV antibody negative participants.||participants with HCV antibody|||Number
717032|NCT00270257|Secondary|Self-reported Number of Injections in the Last Month||Measured through Week 104|Number of participants presented here applies to whom data available at week 104.||injections||Inter-Quartile Range|Median
717033|NCT00270257|Secondary|Number of Participants Reported Using Injection Equipment (Needles, Syringes, Cookers, Cottons, and Rinse Water) in the Prior 6 Months||Measured through Week 104|Number of participants presented here applies to whom data available at week 104.||participants|||Number
717034|NCT00270257|Secondary|Self-report of Continued Injection Opiate Use in the Last 30 Days|All participants completed interviewer-administered assessments of injection and non-injection drug use at baseline and at semi-annual visits.|Measured through Week 104|Number of participants presented here applies to whom data available at week 104.||participants|||Number
717065|NCT00271544|Secondary|Electrical Performance - Tip Electrode: Sensing|Model 4196 lead tip electrode R-wave amplitude|12-month|Subjects with Model 4196 lead implanted and an intrinsic R-wave available at 12-month visit.||millivolt (mV)||Standard Deviation|Mean
717036|NCT00270257|Primary|Evidence of HIV-1 Infection or Death for Visits up to 104 Weeks|The primary endpoint for the study was cumulative HIV infection or death after a second year of follow-up (i.e. at week 104), one year after completion of the treatment phase, designed to test a durable intervention effect.|For visits up to week 104|Data Safety Monitoring Board (DSMB) halted the study on October 4, 2011 due to futility as a result of lower than anticipated HIV incidence rates. See participant flow section for the number of participants who completed visit up to 104 by July 31, 2012.||participants|||Number
717037|NCT00270296|Primary|Number of HIV+ Infants|Number of infants with HIV-positive status|Throughout study, including breastfeeding, assessed up to 24 months|Analysis is based on actual number of available patients, and may not perfectly match the Patient Flow module.||Infants|||Number
717038|NCT00270296|Primary|Number of Participants With Virologic Suppression|Suppression of the plasma HIV-1 RNA level to less than 400 copies per milliliter|Throughout study, including breastfeeding, assessed up to 24 months|||Participants|||Count of Participants
717039|NCT00271219|Secondary|Mother's Psychosocial Functioning at Delivery as Measured by the Addiction Severity Index Psychosocial Index Score|The Addiction Severity Index is a structured clinical interview that assesses problem severity in 7 areas of functioning: alcohol use, drug use, medical, legal, employment, psychosocial, and psychiatric status. Each area of functioning yields a composite scale score between 0 and 1, with higher scores indicating greater problem severity in that area. Only the psychosocial index was examined in this study.|at delivery|||Score on the scale||95% Confidence Interval|Mean
717040|NCT00271219|Secondary|Mother's Measures of Dose Adequacy and Acceptance Over Time (Measured Weekly by Dose Adequacy Measure)|Pregnant women maintained on an opioid agonist medication may require upward adjustment to their medication during the course of pregnant. The Dose Adequacy Measure represented a recordation of dosing adjustments during the course of the study.|from study entry until discontinuation or delivery (min=29 days, max=239 days)|intra-subject variability in dosing (typically 1 dose) over course of the trial was too small to estimate the parameter of interest with sufficient accuracy||dose increase per trimester|||Number
717041|NCT00271219|Secondary|Mother's HIV Risk Behaviors (Measured Monthly by Risk Behavior Assessment)||monthly from study entry until discontinuation or delivery (min=29 days, max=239 days)|frequency of occurrence too low to be estimated with accuracy||percentage of HIV risk behaviors|||Number
717042|NCT00271219|Secondary|Mother's Self-report of Drug Use (Measured Monthly by Time Line Follow Back)||monthly from study entry until discontinuation or delivery (min=29 days, max=239 days)|frequency of use during the course of the study was too low to estimate the parameter with sufficient accuracy||percentage of drug use|||Number
717043|NCT00271219|Primary|Total Amount of Morphine Sulfate That a Neonate Receives to Treat NAS|Total amount in mg|Start of NAS treatment until discontinuation of NAS treatment (min=0 days, max=76 days)|||mg||95% Confidence Interval|Mean
717044|NCT00271219|Primary|Child's Peak Daily Total NAS Score|NAS was measured with the MOTHER NAS scale, which includes 28 items, 19 of which are used for scoring and medication decisions. Scores can range from 0 to 42, with higher scores indicating more severe withdrawal.|minimum twice daily from birth until NAS no longer measured (min=10 days)|||Score on the scale||95% Confidence Interval|Mean
717045|NCT00271219|Primary|Number of Children Requiring Treatment for Neonatal Abstinence Signs (NAS)|Neonatal abstinence syndrome (NAS) characterized by hyperirritability of the central nervous system and dysfunction in the autonomic nervous system, gastrointestinal tract, and respiratory system.11 When left untreated, NAS can result in serious illness (e.g., diarrhea, feeding difficulties, weight loss, and seizures) and death.|From birth until hospital discharge (min=4 days, max=10, depending on site)|||participants|||Number
717046|NCT00271219|Primary|Child's Length of Hospital Stay||delivery until hospital discharge (min=2 days, max=79 days)|||days||95% Confidence Interval|Mean
717047|NCT00271219|Primary|Child's Head Circumference Measurement (Measured at Birth)||birth|||cm||95% Confidence Interval|Mean
717048|NCT00271375|Secondary|Perceived Social Support|Caregiver Perceived Social Support was assessed using the Medical Outcomes Study Social Support Survey (MOS-SSS) a 19-item scale that taps perceived emotional/informational, tangible, and affectionate support, and positive social interaction based on a 5-point likert scale with (1 = None of the time and 5= All of the time) with total score range between 1 and 5. Mean scores were calculated by finding the total sum divided by the total item number, with higher scores indicating better outcome. Calculations were completed at each time interval (baseline, 6month follow-up, and 12month follow-up) and for each study arm (Arm 1, Arm 2 and Arm 3).|Baseline, 6 Month Follow-up, 12 Month Follow-up|||units on a scale||Standard Deviation|Mean
717049|NCT00271375|Secondary|Personal Mastery|Caregiver Personal Mastery was assessed using the Personal Mastery Scale which afforded a general measure of self-perceived ability to manage stressors and effect change in one's life through a 7-item question based on a 5-point likert scale with (5 = Agree A lot and 1= Disagree A lot) and a total score range between 1 and 5. Mean scores were calculated by finding the total sum divided by the total item number, with higher scores indicating poorer outcome. Calculations were completed at each time interval (baseline, 6month follow-up, and 12month follow-up) and for each study arm (Arm 1, Arm 2 and Arm 3).|Baseline, 6 Month Follow-up, 12 Month Follow-up|||units on a scale||Standard Deviation|Mean
717050|NCT00271375|Secondary|Caregiver Efficacy|Caregiver Efficacy was assessed using the RIS Eldercare Self Efficacy Scale (RIS) a 10-item inventory addressing family caregiver's perception of their own ability to manage care provision challenges in the areas of relationship with the care recipient, instrumental care provision, and self-soothing (managing the strains of care provision) based on a 5-point likert scale with (1 = Im certain I CANNOT Do This and 5= Im certain I CAN Do This) with a total score range between1 and 5. Mean scores were calculated by finding the total sum divided by the total item number, higher scores indicating better outcome. Calculations were completed at each time interval (baseline, 6month follow-up, and 12month follow-up) and for each study arm (Arm 1, Arm 2 and Arm 3).|Baseline, 6 Month Follow-up, 12 Month Follow-up|||units on a scale||Standard Deviation|Mean
717066|NCT00271544|Secondary|Assessment of Lead Handling Characteristics|"Lead handling characteristics assessed as acceptable by physicians"|Implant|All available assessments from physicians.||participants|||Number
717067|NCT00271544|Secondary|Total Implant Time|Total implant time was defined as time from initial incision to final closure.|Implant|Subjects successfully implanted with a Model 4196 lead.||minutes||Standard Deviation|Mean
717051|NCT00271375|Secondary|Caregiver Mastery|Caregiver Mastery was assessed using one of the five subscales from the revised Caregiver Appraisal Scale (CAS) through a 4-item question assessing a sense of doing a good job of care provision based on a 5-point likert scale with (5= Agree A lot and 1= Disagree A lot). Mean for the total scores, calculated as the total sum divided by the number of participants, where scores could range from 5 to 20 were calculated, with higher scores indicating poorer outcome. Calculations were completed at each time interval (baseline, 6month follow-up, and 12month follow-up) and for each study arm (Arm 1, Arm 2 and Arm 3).|Baseline, 6 Month Follow-up, 12 Month Follow-up|||units on a scale||Standard Deviation|Median
717052|NCT00271375|Secondary|Caregiver Satisfaction|Caregiver Satisfaction was assessed using one of the five subscales from the revised Caregiver Appraisal Scale (CAS) through 6-items based on a 5-point likert scale with (1 = Disagree A lot and 5= Agree A lot). Mean for the total scores, calculated as the total sum divided by the number of participants, where scores could range from 6 to 30 were calculated, with higher scores indicating poorer outcomes. Calculations were completed at each time interval (baseline, 6month follow-up, and 12month follow-up) and for each study arm (Arm 1, Arm 2 and Arm 3).|Baseline, 6 Month Follow-up, 12 Month Follow-up|||units on a scale||Standard Deviation|Mean
717053|NCT00271375|Secondary|Caregiver Burden|Caregiver Burden was assessed using one of the five subscales from the revised Caregiver Appraisal Scale (CAS) through 9-items based on a 5-point likert scale with (1 = Never and 5= Nearly always). Mean for the total scores, calculated as the total sum divided by the number of participants, where scores could range from 9 to 45 were calculated, with higher scores indicating poorer outcomes. Calculations were completed at each time interval (baseline, 6month follow-up, and 12month follow-up) and for each study arm (Arm 1, Arm 2 and Arm 3).|Baseline, 6 Month Follow-up, 12 Month Follow-up|||units on a scale||Standard Deviation|Mean
717054|NCT00271375|Secondary|Depressive Symptoms|Depression symptoms were assessed using the Center for Epidemiological Studies Depression Scale (CES-D Short Form). The CES-D is a 10 Question Scale with total scores ranging from 0-30. Mean scores were calculated by finding the total sum divided by the total number of participants. Any score equal to or above 10 is considered depressed. Calculations were completed at each time interval (baseline, 6month follow-up, and 12month follow-up) and for each study arm (Arm 1, Arm 2 and Arm 3).|Baseline, 6 Month Follow-up, 12 Month Follow-up|||units on a scale||Standard Deviation|Mean
717055|NCT00271375|Secondary|Physical Function|Physical function was assessed using one of the eight subscales from the Medical Outcomes Study Health Survey Short Form (SF-36) which is represented by 10 items tapping basic functional abilities of the caregiver (Does their health limit them in the following activities). 10 items were scored on a 3-Point Likert Scale with 1= Limited A lot and 3= Not Limited and total scale range between 1 and 3. Mean scores were calculated by finding the total sum divided by the total item number, with lower scores indicating poorer outcome. Calculations were completed at each time interval (baseline, 6month follow-up, and 12month follow-up) and for each study arm (Arm 1, Arm 2 and Arm 3).|Baseline, 6 Month Follow-up, 12 Month Follow-up|||units on a scale||Standard Deviation|Mean
717056|NCT00271375|Secondary|Physical Role Function|Physical Role Function was assessed using one of the eight subscales from the Medical Outcomes Study Health Survey Short Form (SF-36) which looked at how emotional or physical issues interfered with everyday social roles of the caregiver. 4 items were scored on a 5-point Likert scale (1 = All of the time and 5= None of the time) with total scale range between 1 and 5. Mean scores were calculated by finding the total sum divided by the total item number, with lower scores indicating poorer outcome. Calculations were completed at each time interval (baseline, 6month follow-up, and 12month follow-up) and for each study arm (Arm 1, Arm 2 and Arm 3).|Baseline, 6 Month Follow-up, 12 Month Follow-up|||units on a scale||Standard Deviation|Mean
717057|NCT00271375|Secondary|Subjective Health|Subjective Health was assessed using one of the eight subscales from the Medical Outcomes Study Health Survey Short Form (SF-36) which looked at the how the respondent (caregiver) perceived their own health currently and compared to a year ago. Two items were based on a 5-point Likert scale (1 =Excellent and 5= Poor) with a total scale range between 1 and 5. Mean scores were calculated by finding the total sum divided by the total number of items, with higher scores indicating poorer outcomes. Calculations were completed at each time interval (baseline, 6month follow-up, and 12month follow-up) and for each study arm (Arm 1, Arm 2 and Arm 3).|Baseline, 6 Month Follow-up, 12 Month Follow-up|||units on a scale||Standard Deviation|Mean
717058|NCT00271375|Primary|"To Evaluate User Satisfaction With and Perceived Utility of the Caring for You, Caring for Me Caregiver Educational Program Among Formal (VHA Staff) and Informal (Family) Caregivers Who Undergo the Program"|This question addresses user satisfaction, in terms of caregiving perceived utility of the education program, as well as their actual use of knowledge and skills gained in their caregiving situation.|18 Months|"User evaluation of the Caring for you, Caring for me education program. Data for participants in the Caring for you, Caring for me education program only and Caring for you, Caring for me education program+ Social Work were combined during data collection. Only 71 participants provided results. No data was collected from control group."||participants|||Number
717059|NCT00271544|Secondary|Summarize All Adverse Events|All adverse events were collected for this trial such as, but not limited to, the following: Atrial Fibrillation, Chest Pain, Pneumonia, Cold/Flu|Up to 18 months|All subjects enrolled into the 4196 study.||adverse events|||Number
717060|NCT00271544|Secondary|Electrical Performance -Ring Electrode: Pacing Impedance|Model 4196 lead ring electrode pacing impedance|12-Month|Subjects with Model 4196 lead implanted and completed 12-month visit.||Ohms||Standard Deviation|Mean
717061|NCT00271544|Secondary|Electrical Performance - Ring Electrode: LV Voltage Threshold|Model 4196 lead ring electrode LV voltage threshold|12-month|Subjects with Model 4196 lead implanted and 12-month visit completed.||Volts||Standard Deviation|Mean
717062|NCT00271544|Secondary|Electrical Performance -Ring Electrode: Sensing|Model 4196 lead ring electrode R-wave amplitude|Implant|Subjects with Model 4196 lead implanted and with intrinsic R-wave amplitude at implant.||mV||Standard Deviation|Mean
717063|NCT00271544|Secondary|Electrical Performance -Tip Electrode: Pacing Impedance|Model 4196 lead tip electrode pacing impedance|12-month|Subjects with Model 4196 lead implanted and 12-month visit completed.||Ohms||Standard Deviation|Mean
717064|NCT00271544|Secondary|Electrical Performance - Tip Electrode: LV Voltage Threshold|Model 4196 lead tip electrode LV voltage threshold|12-month|Subjects with Model 4196 lead implanted and 12-month visit completed.||Volts||Standard Deviation|Mean
717068|NCT00271544|Secondary|Model 4196 Lead Placement Time|Model 4196 lead placement time was defined as the time from insertion of the successfully placed lead to the time when it was placed in the first acceptable pacing location.|Implant|Subjects successfully implanted with a Model 4196 lead.||minutes||Standard Deviation|Mean
717069|NCT00271544|Secondary|Fluoroscopy Time|Fluoroscopy time was defined as the total time the fluoroscope was imaging.|Implant|Subjects successfully implanted with a Model 4196 lead.||minutes||Standard Deviation|Mean
717070|NCT00271544|Secondary|Cannulation Time|Cannulation time was defined as the time from insertion of the first CS cannulation catheter to the first CS cannulation.|Implant|Subjects successfully implanted with a Model 4196 lead.||minutes||Standard Deviation|Mean
717071|NCT00271544|Secondary|All Medtronic Left Ventricular Leads (Attain Family)|All Medtronic left ventricular leads (Lead Model Numbers included 4193, 4194, 4195 and 4196) successfully implanted|Implant|Subjects who underwent an implant attempt.||participants|||Number
717072|NCT00271544|Secondary|All Left Ventricular Leads|All left ventricular leads successfully implanted|Implant|Subjects who underwent an implant attempt.||participants|||Number
717073|NCT00271544|Secondary|Subjects Successfully Implanted After Cannulation|A successful implant occurs when the coronary sinus (CS) is successfully cannulated and a left ventricular lead is implanted in the left ventricle of the heart and functions appropriately.|Implant|Subjects with successful CS cannulation after an incision was made (implant attempt)||participants|||Number
717074|NCT00271544|Primary|Efficacy (Pacing Voltage Threshold of Proximal Ring Electrode)|Model 4196 lead proximal ring electrode mean pacing voltage threshold (at 0.5 milliseconds [ms])|Three Months|Subjects with pacing threshold at ring electrode captured at 0.5 milliseconds (ms) at 3-month visit.||volts||Standard Deviation|Mean
717075|NCT00271544|Primary|Efficacy (Pacing Voltage Thresholds of Distal Tip Electrode)|Model 4196 lead distal tip electrode mean pacing voltage threshold (at 0.5 milliseconds [ms])|One Month|Subjects with pacing threshold at tip electrode captured at 0.5 milliseconds (ms) at 1-month visit.||volts||Standard Deviation|Mean
717076|NCT00271544|Secondary|Subjects Successfully Implanted With Model 4196 Lead|A successful implant occurs when the Model 4196 lead is implanted in the left ventricle of the heart and functions appropriately.|Implant|Subjects who underwent Model 4196 lead implant attempt.||participants|||Number
717077|NCT00271544|Primary|Safety (Subjects Without a Model 4196 Lead Related Complication)|A subject who was free of a Model 4196 lead related complication by one month visit.|One Month|Subjects who underwent a Model 4196 left ventricular (LV) lead implant attempt and completed 1-month visit; or experienced Model 4196 lead related complications by 1-month visit.||participants|||Number
717078|NCT00271570|Primary|Area Under the Curve of Infliximab Concentration Before Infliximab Infusion and Then 2 and 24 Hours, 1 Week (5 to 9 Days), 2 Weeks (12 to 16 Days), and 4 Weeks (26 to 30 Days) After Infliximab Infusion)|The area under the curve (AUC) from time 0 to the last measurable concentration (AUC0-last) was estimated using the trapezoidal rule up to the last measurable concentration.Samples were collected before infliximab infusion and then at 2 and 24 hours, 1 week (5 to 9 days), 2 weeks (12 to 16 days), and 4 weeks (26 to 30 days) after infliximab infusion. Subjects with detectable infliximab concentrations at week 4 had another sample drawn at week 10 (68 to 72 days).|before infliximab infusion and then 2 and 24 hours, 1 week (5 to 9 days), 2 weeks (12 to 16 days), and 4 weeks (26 to 30 days) after infliximab infusion.|||micogram*day/ml||Inter-Quartile Range|Median
717079|NCT00271570|Primary|Number of Adverse Events (Focused on Side Effects From IVIG or Infliximab Administration)|The safety of giving infliximab to treat IVIG-resistant Kawasaki disease was measured by recording the number of adverse events that occurred in each group. An adverse event (AE) was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of either IVIG or infliximab, regardless of whether it was considered related to IVIG or infliximab, that occured during the course of this study.In particular we evaluated for AEs related to side effects from infliximab or IVIG.|2 weeks|||events|||Number
717080|NCT00271596|Secondary|Subgroup Analysis of the Hamilton Depression Rating Scale Comparing Screening (Intake Visit) to Visit 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort|Full Scale Name: Hamilton Rating Scale for Depression (HAM-D). Definition: The Hamilton Rating Scale for Depression is a clinician-administered multiple item questionnaire used to provide an indication of depression. Construct Measured: Depression. HAM-D Score Range: Raw scores may range from 0 to 54, where higher scores indicate worsening mood. Change Calculation Details: This analysis was restricted to a subgroup and, accordingly, does not reflect the total number of participants as reported in the Participant Flow. This analysis compares change in mood from screening (intake visit) to visit 6 (week 15) for the citalopram versus placebo cohort.|after 15 weeks of treatment|This analysis was restricted to a subgroup and, accordingly, does not reflect the total number of participants as reported in the Participant Flow. This analysis compares change in mood from screening (intake visit) to visit 6 (week 15) for the citalopram versus placebo cohort.||units on a scale||Standard Error|Least Squares Mean
717081|NCT00271596|Secondary|Total Functional Capacity Score Comparing Baseline (Week -4) to Visits 4 (Week 6) & 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort|Full Scale Name: The Total Functional Capacity (TFC) subscale from the Unified Huntington’s Disease Rating Scale (UHDRS). Definition: The TFC is a score that classifies five stages of Huntington's Disease and five levels of function in the domains of workplace, finances, domestic chores, activities of daily living and requirements for unskilled or skilled care. Construct Measured: Activities of Daily Living. Scale Range: The TFC score ranges from 0 to 13, where lower scores indicate poorer performance in activities of daily living. Change Calculation Details: Compares change in TFC performance from Baseline (week -4) to the weighted average of visits 4 (week 6) and 6 (week 15) for the citalopram versus placebo cohort.|after 15 weeks of treatment|Intention to treat analysis was performed using a mixed linear model comparing baseline (week -4) to the weighted average of Visits 4 (week 6) & 6 (week 15) for the citalopram versus placebo cohort||units on a scale||Standard Error|Least Squares Mean
717101|NCT00271817|Secondary|Percent Change From Baseline in Triglycerides (TG)|Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in Triglycerides after 24 weeks - 24 week measure minus baseline|baseline and 24 Weeks|The participant population for this analysis is the Completers Population. This includes all patients with a baseline value, who receive at least 24 weeks of active study therapy, and who have an on-treatment measurement at the maximum titrated dose per the protocol.||Percent change||Standard Deviation|Median
717082|NCT00271596|Secondary|Hamilton Rating Scale for Depression Comparing Screening (Intake Visit) to Visit 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort|Full Scale Name: Hamilton Rating Scale for Depression (HAM-D). Definition: The Hamilton Rating Scale for Depression is a clinician-administered multiple item questionnaire used to provide an indication of depression. Construct Measured: Depression. HAM-D Score Range: Raw scores may range from 0 to 54, where higher scores indicate worsening mood. Change Calculation Details: Compares change in mood from screening (intake visit) to visit 6 (week 15) for the citalopram versus placebo cohort.|after 15 weeks of treatment|Intention to treat analysis was performed using a mixed linear model comparing screening (intake visit) to Visit 6 (week 15) for the citalopram versus placebo cohort||units on a scale||Standard Error|Least Squares Mean
717083|NCT00271596|Secondary|Trails B Score Comparing Visit 2 (Week 0) to Visits 5 (Week 12) & 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort|Full Scale Name: Trail Making Test Part B (TMT-B). Definition: The TMT-B test requires participants to “connect-the-dots” of 25 consecutive targets on a sheet of paper where the subject alternates between numbers and letters, going in both numerical and alphabetical order. Constructs Measured: Attention, set shifting, and processing speed. Scale range: The TMT-B score ranges from -5 to +5 on a standardized (Z) score scale, where lower scores indicate poorer performance. Change Calculation Details: Compares change in attention and processing speed performance from visit 2 (week 0) to the weighted average of visits 5 (week 12) and 6 (week 15) for the citalopram versus placebo cohort.|after 15 weeks of treatment|Intention to treat analysis was performed using a mixed linear model controlling for practice effects comparing visit 2 (week 0) to the weighted average of visits 5 (week 12) & 6 (week 15) for the citalopram versus placebo cohort||units on a scale||Standard Error|Least Squares Mean
717084|NCT00271596|Secondary|Stroop Interference Score Comparing Visit 2 (Week 0) to Visits 5 (Week 12) & 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort|"Full Scale Name: Stroop Interference subtest from The Stroop Color and Word Test. Definition: Participants are asked to name the ink color in which a word is printed when the word itself (which is irrelevant to the task) is the name of a different color rather than the same color. For example, participants may be asked to say red to the word blue printed in red ink. Constructs Measured: Selective attention, response inhibition, cognitive flexibility, and processing speed. Scale Range: The Stroop Interference score ranges from -5 to +5 on a standardized (Z) score scale, where lower scores indicate poorer performance. Change Calculation Details: Compares change in attention and processing speed performance from visit 2 (week 0) to the weighted average of visits 5 (week 12) and 6 (week 15) for the citalopram versus placebo cohort."|after 15 weeks of treatment|Intention to treat analysis was performed using a mixed linear model controlling for practice effects comparing visit 2 (week 0) to the weighted average of visits 5 (week 12) & 6 (week 15) for the citalopram versus placebo cohort||units on a scale||Standard Error|Least Squares Mean
717085|NCT00271596|Secondary|Verbal Fluency Score Comparing Visit 2 (Week 0) to Visits 5 (Week 12) & 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort|Full Scale Name: The Verbal Fluency Score (VFC). Definition: The VFC is the number of words a person can produce given a letter, including (1) Naming words that start with F, A, and S; (2) naming words that start with K, W, and R; (3) naming words that start with V, I, and P; (4) naming words that start with O, G, and B; (5) naming words that start with E, N, and T; and (6) naming words that start with J, C, and S. Construct Measured: Verbal initiation and flexibility. Scale Range: The Verbal Fluency Composite Score ranges from -5 to +5 on a standardized (Z) score scale, where lower scores indicate poorer performance. Change Calculation Details: Compares change in verbal initiation and flexibility from visit 2 (week 0) where patients named words starting with O, G, and B to the weighted average of visits 5 (week 12) and 6 (week 15) where patients named words starting with E, N, and T, and J, C, and S respectively for the citalopram versus placebo cohort.|after 15 weeks of treatment|Intention to treat analysis was performed using a mixed linear model controlling for practice effects comparing visit 2 (week 0) to the weighted average of visits 5 (week 12) & 6 (week 15) for the citalopram versus placebo cohort||units on a scale||Standard Error|Least Squares Mean
717086|NCT00271596|Secondary|Symbol-Digit Modalities Score Comparing Visit 2 (Week 0) to Visits 5 (Week 12) & 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort|Full Scale Name: The Symbol Digit Modalities Test (SDMT). Definition: The SDMT screens for organic cerebral dysfunction by having the examinee use a reference key to pair specific numbers with given geometric figures in 90 seconds. Construct Measured: Attention, processing speed, and working memory. SDMT Scale Range: Raw scores may range from 0 to 110, where lower scores indicate poorer performance. Change Calculation Details: Compares change in performance from visit 2 (week 0) to the weighted average of visits 5 (week 12) & 6 (week 15) for the citalopram versus placebo cohort.|after 15 weeks of treatment|Intention to treat analysis was performed using a mixed linear model controlling for practice effects comparing visit 2 (week 0) to the weighted average of visits 5 (week 12) & 6 (week 15) for the citalopram versus placebo cohort||units on a scale||Standard Error|Least Squares Mean
717087|NCT00271596|Secondary|Semantic Fluency Score Comparing Visit 2 (Week 0) to Visits 5 (Week 12) & 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort|Semantic Fluency Score. Definition: The Semantic Fluency Score is the number of words a person can produce given a category, including naming (1) Animal names, (2) Fruit names, (3) Boy names, (4) Girl names, and (5) Vegetable names. Construct Measured: Working memory and verbal initiation. Scale Range: The Semantic Fluency Score ranges from -5 to +5 on a standardized (Z) score scale, where lower scores indicate poorer performance on working memory tasks. Change Calculation Details: Compares change in working memory performance from visit 2 (week 0) where patients named fruit names to the weighted average of visits 5 (week 12) & 6 (week 15) where patients named girl names and vegetable names respectively for the citalopram versus placebo cohort.|after 15 weeks of treatment|Intention to treat analysis was performed using a mixed linear model controlling for practice effects comparing visit 2 (week 0) to the weighted average of visits 5 (week 12) & 6 (week 15) for the citalopram versus placebo cohort||units on a scale||Standard Error|Least Squares Mean
717102|NCT00271817|Secondary|Percent Change From Baseline in High-Density Lipoprotein-Cholesterol (HDL-C)|Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in HDL-C after 24 weeks - 24 week measure minus baseline|Baseline and 24 weeks|The participant population for this analysis is the Completers Population. This includes all patients with a baseline value, who receive at least 24 weeks of active study therapy, and who have an on-treatment measurement at the maximum titrated dose per the protocol.||Percent change||Standard Error|Mean
717088|NCT00271596|Secondary|Letter Number Sequencing Score Comparing Visit 2 (Week 0) to Visits 5 (Week 12) & 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort|Full Scale Name: Letter Number Sequencing (LNS) subtest from the Wechsler Adult Intelligence Scale (WAIS) third edition. Definition: LNS is a task that requires the reordering of an initially unordered set of letters and numbers. Construct Measured: Working memory. LNS Score Range: Raw scores may range from 0 to 21, where lower scores indicate poorer performance in working memory. Change Calculation Details: Compares change in working memory performance from visit 2 (week 0) to the weighted average of visits 5 (week 12) & 6 (week 15) for the citalopram versus placebo cohort.|after 15 weeks of treatment|Intention to treat analysis was performed using a mixed linear model controlling for practice effects comparing visit 2 (week 0) to the weighted average of visits 5 (week 12) & 6 (week 15) for the citalopram versus placebo cohort||units on a scale||Standard Error|Least Squares Mean
717089|NCT00271596|Primary|Executive Function Composite Score Comparing Visit 2 (Week 0) to Visits 5 (Week 12) & 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort.|Full Scale Name: The Executive Composite Score (ECS). Definition: Subscales were averaged to compute this composite total score. The ECS is the weighted average of performance on 6 subtests of executive function, including (1) the Controlled Oral Word Association Test, (2) Symbol Digit Modalities test; (3) Stroop Color Word Test (Interference Trial), (4) Trail Making test (Part B), (5) Letter-Number Sequencing, and (6) Animal Naming. Construct Measured: Thinking tasks involving planning, working memory, attention, problem solving, verbal reasoning, inhibition, mental flexibility, and task switching. ECS Scale Range: The ECS score ranges from -5 to +5 on a standardized (Z) score scale, where lower scores indicate poorer performance on executive functioning tasks. Change Calculation Details: Compares change in executive functioning performance from visit 2 (week 0) to the weighted average of visits 5 (week 12) & 6 (week 15) for the citalopram versus placebo cohort.|after 15 weeks of treatment|Intention to treat analysis was performed using a mixed linear model controlling for practice effects comparing visit 2 (week 0) to the weighted average of visits 5 (week 12) & 6 (week 15) for the citalopram versus placebo cohort||units on a scale||Standard Error|Least Squares Mean
717090|NCT00271609|Primary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|5 years|||Participants|||Number
717091|NCT00271609|Primary|Percentage of Participants With Progression Free Survival at 6 Months.|Percentage of participants surviving without progression of disease after six months of study entry. Progression is defined as a 25% increase in lesions, clear worsening of any evaluable disease, or appearance of any new lesion/site (e.g. by computed tomography, magnetic resonance imaging), or failure to return for evaluation due to death or deteriorating condition.|6 months|at the time of data cutoff for this endpoint, 31 patients in the AG arm and 48 patients in the GBM arm were evaluable for PFS.||Percentage of participants||95% Confidence Interval|Number
717092|NCT00271739|Primary|Serum Lipids Levels; Low-density Lipoprotein (LDL)-Cholesterol||5 years|||mg/dL||Standard Error|Mean
717093|NCT00271739|Primary|Blood Pressure Levels||5 years|||mmHg||Standard Error|Mean
717094|NCT00271739|Primary|Hemoglobin A1c Levels||5 years|||A1c percentage||Standard Error|Mean
717095|NCT00271817|Secondary|Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)|Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in non-HDL-C after 24 weeks - 24 week measure minus baseline|Baseline and 24 weeks|The analysis population is the modified intention-to-treat population, which includes patients that were randomized to ezetimibe/simvastatin + niacin or ezetimibe/simvastatin treatment groups and have a baseline measurement and at least on measurement beyond Week 24.||Percent change||Standard Error|Mean
717096|NCT00271817|Primary|Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C)|Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in LDL-C after 24 weeks - 24 week measure minus baseline|Baseline and 24 weeks|The participant population for this analysis is the Completers Population. This includes all patients with a baseline value, who receive at least 24 weeks of active study therapy, and who have an on-treatment measurement at the maximum titrated dose per the protocol.||Percent change||Standard Error|Mean
717097|NCT00271817|Secondary|Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C)|Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in LDL-C after 64 weeks - 64 week measure minus baseline|Baseline and 64 weeks|The analysis population is the modified intention-to-treat population, which includes patients that were randomized to ezetimibe/simvastatin + niacin or ezetimibe/simvastatin treatment groups and have a baseline measurement and at least on measurement beyond Week 24.||Percent change||Standard Error|Mean
717098|NCT00271817|Secondary|Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)|Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in non-HDL-C after 64 weeks - 64 week measure minus baseline|Baseline and 64 weeks|The analysis population is the modified intention-to-treat population, which includes patients that were randomized to ezetimibe/simvastatin + niacin or ezetimibe/simvastatin treatment groups and have a baseline measurement and at least on measurement beyond Week 24.||Percent change||Standard Error|Mean
717099|NCT00271817|Secondary|Percent Change From Baseline in Triglycerides (TG)|Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in Triglycerides after 64 weeks - 64 week measure minus baseline|Baseline and 64 weeks|The analysis population is the modified intention-to-treat population, which includes patients that were randomized to ezetimibe/simvastatin + niacin or ezetimibe/simvastatin treatment groups and have a baseline measurement and at least on measurement beyond Week 24.||Percent change||Standard Deviation|Median
717100|NCT00271817|Secondary|Percent Change From Baseline in High-Density Lipoprotein-Cholesterol (HDL-C)|Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in HDL-C after 64 weeks - 64 week measure minus baseline|Baseline and 64 weeks|The analysis population is the modified intention-to-treat population, which includes patients that were randomized to ezetimibe/simvastatin + niacin or ezetimibe/simvastatin treatment groups and have a baseline measurement and at least on measurement beyond Week 24.||Percent change||Standard Error|Mean
717103|NCT00271817|Secondary|Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)|Ezetimibe/simvastatin co-administered with niacin extended release compared to niacin extended release monotherapy on the percent change from baseline in non-HDL-C after 24 weeks - 24 week measure minus baseline|Baseline and 24 weeks|The participant population for this analysis is the Completers Population. This includes all patients with a baseline value, who receive at least 24 weeks of active study therapy, and who have an on-treatment measurement at the maximum titrated dose per the protocol.||Percent change||Standard Error|Mean
717104|NCT00271817|Primary|Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C)|Ezetimibe/simvastatin co-administered with niacin extended release compared to niacin extended release monotherapy on the percent change, from baseline in LDL-C after 24 weeks - 24 Week Measure Minus Baseline|Baseline and 24 Weeks|The participant population for this analysis is the Completers Population. This includes all patients with a baseline value, who receive at least 24 weeks of active study therapy, and who have an on-treatment measurement at the maximum titrated dose per the protocol.||Percent change||Standard Error|Mean
717105|NCT00271856|Primary|Change in Depression as Measured by the Patient Health Questionnaire-9 (PHQ-9)|We used the Patient Health Questionnaire (PHQ-9) as a measure of depressive symptom severity. The PHQ-9 is the depression module of the self-administered version of the Primary Care Evaluation of Mental Disorders (PRIME-MD) diagnostic instrument. Participants rate the frequency of 9 depression symptoms over the past 2 weeks from 0 (not at all) to 3 (nearly every day). Scores range from 0 to 27, with higher scores reflecting greater severity of depressive symptoms.|baseline to 12 months|ITT analyses.||scores on the scale||95% Confidence Interval|Mean
717106|NCT00271856|Primary|Change in Positive and Negative Affect Scale (PANAS) Negative Affect (NA) Score|Emotion was assessed with the Positive and Negative Affect Schedule (PANAS\). The PANAS measures intensity of positive and negative emotions over the past week. The scale consists of 20 items--10 positive and 10 negative emotions. Respondents are asked to indicate how strongly they felt each emotion on a scale from 0 to 4 (not at all to extremely). The Negative Affect (NA) score is derived from summing the scores on the 10 negative emotions. Scores on the NA subscale range from 0-40, with higher scores reflecting more negative affect over the past week.|baseline to 12 months|ITT analyses.||scores on the scale||95% Confidence Interval|Mean
717107|NCT00271856|Primary|Change in Positive and Negative Affect (PANAS) Positive Affect (PA) Score|Emotion was assessed with the Positive and Negative Affect Schedule (PANAS). The PANAS measures intensity of positive and negative emotions over the past week. The scale consists of 20 items--10 positive and 10 negative emotions. Respondents are asked to indicate how strongly they felt each emotion on a scale from 0 to 4 (not at all to extremely). The Positive Affect (PA) score is derived from summing the scores on the 10 positive emotions. Scores on the PA subscale range from 0-40, with higher scores reflecting more positive affect over the past week.|baseline to 12 months|ITT analyses||scores on the scale||95% Confidence Interval|Mean
717108|NCT00271856|Primary|Change in Perceived Stress as Measured by Perceived Stress Scale (PSS)|Perception of stress was measured with the 10-item version of the Perceived Stress Scale. This widely used measure of perceived stress was designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives. Participants rate how often they felt or thought a certain way over the past month on a 4-point scale (0 = Never, 4 = Very Often). Scores range from 0-40, with higher scores reflecting greater perceived stress.|baseline to 12 months|ITT analyses.||scores on the scale||95% Confidence Interval|Mean
717109|NCT00271856|Primary|Change in Depression as Measured by Beck Depression Inventory (BDI)|The BDI is a widely used outcome measure for studies of depression. The BDI consists of 21 items that are rated on a 4-point scale according to how severely they are experienced. Scores range from 0-63, with higher scores reflecting greater depression.|baseline to 12 months|ITT analyses.||scores on the scale||95% Confidence Interval|Mean
717110|NCT00271856|Primary|Change in CD4 T-cell Count||baseline to 12 months|Intent to treat (ITT) analyses. Multiple imputation method used for those who started antiretroviral therapy (ART) between 0 and 12 months.||cells/µl||95% Confidence Interval|Mean
717111|NCT00271856|Secondary|Quality of Life (Short Form Health Survey; SF-36); Cortisol (Basal a.m. and Diurnal Change); T-cell Activation (i.e. CD38-cell Surface Marker) and NK Cell Number and Function; Autonomic Nervous System Activity ; Cell Aging||3, 6, and 12 months||||||
717112|NCT00271947|Primary|Number of Participants With Remission or Clinical Improvement as Assessed by Crohn's Disease Activity Index (CDAI) Scores|Clinical remission defined as a CDAI less than 150 and clinical improvement defined as decline in CDI> or = 70 one year following entry. The participant was not assessed according to the criteria of the outcome measure, because the participant was lost for follow-up.|baseline||||||
717113|NCT00272038|Secondary|Toxicity||during study||||||
717114|NCT00272038|Secondary|Overall Survival|One year survival rate.|during study|||percentage of partcipants|||Number
717115|NCT00272038|Secondary|Time to Disease Progression (TTP)|Progression is defined using response evaluation criteria in solid tumors criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a meausrable increase in a non-target lesion, or the appearance of new lesions or the appearance of two new bone lesions.|five years|||months||Full Range|Mean
717116|NCT00272038|Primary|Overall Clinical Benefit of Tarceva in CRPC.|Overall Clinical Benefit= percentage of partial responders (PR)+ the percentage of patients with stable disease (SD). Partial Response (PR) is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum. Stable Disease (SD)is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease, using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0).|5 years|||percentage of pts w/clinical benefit|||Number
717117|NCT00272168|Primary|Employment Status|Data collected included from participants: weekly wages earned|Post Treatment (approximately 3 months after completion of the baseline assessment)|||dollars/week||Standard Deviation|Mean
717118|NCT00272168|Primary|Social Functioning|"This was assessed using the Maryland Assessment of Social Competence (MASC), which assesses participants social problem solving skill abilities in both work-related and non-work related situations. Using three scenes, the participant is rated on the following scale for each scene. Overall score is then averaged to arrive at a final score.
Very Poor
Poor
Neither good nor poor
Somewhat good
Very good"|Post Treatment|||units on a scale||Standard Deviation|Mean
717119|NCT00272168|Primary|Work Performance (Work Behavior Inventory)|"This measure is completed with participants' supervisors and assesses current work behavior and vocational function. The WBI yields six scores related to fundamental work requirements: social skills, cooperativeness, work habits, work quality personal presentation, and a general score of overall work performance. Each of these is rated between 1-5:
Consistently an area Needing Improvement
Occasionally an area Needing Improvement
Performance Adequate in this area
Occasionally an area of Superior Performance
Consistently an area of Superior Performance.
The global impression of work behavior (overall rating of work functioning using the same 1-5 scale) was used for the purpose of reporting results for this study."|Post Treatment|||rating on a scale||Standard Deviation|Mean
717120|NCT00272168|Secondary|Psychiatric Symptoms|Psychiatric Symptoms were assessed using the Brief Psychiatric Rating Scale (BPRS), a widely used instrument for assessing the positive, negative, and affective symptoms of individuals who have mental illnesses. The BPRS consists of 20 symptom constructs scored from 1 (not present) to 7 (extremely severe). BPRS total score could range from 0 (not present) to 140 (extremely severe).|Post-Treatment|||scores on a scale||Standard Deviation|Mean
717121|NCT00272168|Secondary|Cognitive Insight|"Cognitive insight was assessed using the Beck Cognitive Insight Scale, a 15-item questionnaire developed to evaluate patients' self-reflectiveness and their overconfidence in their interpretations of their experiences. Participant responses to each of these items were as follows:
Do not agree at all
Agree slightly
Agree a lot
Agree completely
Total score for the self-certainty scale could range from 6 to 24. Total score for the self-reflectiveness scale could range from 9 to 36. Total score for the composite score was calculated by subtracting the summed score for the self-certainty scale from the summed score of the self-reflectiveness scale and could range from 3 to 12, lower composite scores are an indicator of lower psychiatric functioning."|Post Treatment|||units on a scale||Standard Deviation|Mean
717122|NCT00272168|Primary|Employment Status|Data collected included from participants: 1) hours scheduled to work per week and 2) weekly wages earned.|Post Treatment (approximately 3 months after completion of the baseline assessment)|||Hours worked per week||Standard Deviation|Mean
717123|NCT00272311|Primary|Change in Nitric Oxide Formation From Baseline to 3 Months|Changes in Heme oxygenase (HO-1) a downstream target of nitric oxide (NO) formation.|Baseline to 3 Months (90-97 days)|Complete baseline and follow-up data||ng/mL||Standard Deviation|Mean
717124|NCT00272311|Primary|Change in Platelet Biomarkers From Baseline to 3 Months||Baseline to 3 Months (90-97 days)||||||
717125|NCT00272311|Primary|Change in Inflammatory Markers From Baseline to 3 Months||Baseline to 3 Months (90-97 days)||||||
717126|NCT00272337|Secondary|Chagne in Endothelial Function From Baseline to 3 Months||Baseline to 3 Months (90-97 days)||||||
717127|NCT00272337|Primary|Change in Nitric Oxide Formation From Baseline to 3 Months.|Heme oxygenase a downstream target of nitric oxide formation|Baseline to 3 Months (90-97 days)|Complete baseline and follow-up data||ng/mL||Standard Deviation|Mean
717128|NCT00272337|Primary|Change in Platelet Biomarkers From Baseline to 3 Months.||Baseline to 3 Months (90-97 days)||||||
717129|NCT00272337|Primary|Change in Inflammatory Markers From Baseline to 3 Months.||Baseline to 3 Months (90-97 days)||||||
717130|NCT00272779|Primary|Mean Change From Baseline in VAT-to-TAT Ratio Associated With CCDA122_5980|The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair. VAT and TAT were measured by computed tomography (CT).|Baseline (Day 1), Week 48, and Week 96.|Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.||cm^2||Standard Error|Mean
717131|NCT00272779|Primary|Mean Change From Baseline in VAT Associated With RETN_730|The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair. VAT was measured by computed tomography (CT).|Baseline (Day 1), Week 48, and Week 96.|Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.||cm^2||Standard Error|Mean
717132|NCT00272779|Primary|Mean Change From Baseline in Visceral Adipose Tissue (VAT) Associated With BRUNOL_1842|The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair. VAT was measured by computed tomography (CT).|Baseline (Day 1), Week 48, and Week 96.|Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.||cm^2||Standard Error|Mean
717133|NCT00272779|Primary|Mean Change From Baseline in Subcutaneous Adipose Tissue (SAT)-To-Trunk Adipose Tissue (TAT) Ratio Associated With CCDC122_5980|The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair. SAT and TAT were measured by computed tomography (CT).|Baseline (Day 1), Week 48, and Week 96.|Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.||cm^2||Standard Error|Mean
719148|NCT00294645|Secondary|Percentage of Participants With an Increase in Ventricular Pacing Voltage Threshold Greater Than 1 Volt (V) at 12 Months|Compare time to first diagnosis in Control and Remote arms|One year post-enrollment|||Percentage of participants|||Number
717134|NCT00272779|Primary|Mean Change From Baseline in Fasting Tumor Necrosis Factor (TNF)-Alpha Asssociated With RS11030679|The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.|Baseline (Day 1), Week 48, and Week 96.|Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.||pg/mL||Standard Error|Mean
717135|NCT00272779|Primary|Mean Change From Baseline in Fasting Tumor Necrosis Factor (TNF)-Alpha Associated With IL6_5309|The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.|Baseline (Day 1), Week 48, and Week 96.|Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.||pg/mL||Standard Error|Mean
717136|NCT00272779|Primary|Mean Change From Baseline in Fasting Plasminogen Activator Inhibitor (PAI)-1 Associated With APOE_R176C|The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.|Baseline (Day 1), Week 48, and Week 96.|Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.||ng/dL||Standard Error|Mean
717137|NCT00272779|Primary|Mean Change From Baseline in Fasting Triglycerides Associated With RETN_734|The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.|Baseline (Day 1), Week 48, and Week 96.|Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.||mg/dL||Standard Error|Mean
717138|NCT00272779|Primary|Mean Change From Baseline in Fasting Triglycerides Associated With APOE_C130R|The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.|Baseline (Day 1), Week 48, and Week 96.|Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.||mg/dL||Standard Error|Mean
717139|NCT00272779|Primary|Mean Change From Baseline in Fasting Triglycerides Associated With RETN_598|The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.|Baseline (Day 1), Week 48, and Week 96.|Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.||mg/dL||Standard Error|Mean
717140|NCT00272779|Primary|Mean Change From Baseline in Fasting Triglycerides Associated With RETN_2265|The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.|Baseline (Day 1), Week 48, and Week 96.|Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.||mg/dL||Standard Error|Mean
717141|NCT00272779|Primary|Mean Change From Baseline in Fasting Triglycerides Associated With RETN_097|The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.|Baseline (Day 1), Week 48, and Week 96.|Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.||mg/dL||Standard Error|Mean
717170|NCT00272779|Primary|AUC (0-24) of RTV at Week 4|AUC (0-24) was derived from plasma concentration versus time data. It was estimated as 2 times the AUC(TAU) based on 12-hour PK.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.|All participants who completed the intensive PK study.||ng*h/mL||Full Range|Geometric Mean
717391|NCT00273754|Secondary|Awakening Time|A child with a Steward Recovery Scale score of 6 is defined as awake, coughing/crying, and has purposeful movements.|Awakening time from end of anesthesia until the child reached a score of 6 on the Steward recovery score.|||Minutes||Standard Deviation|Mean
717142|NCT00272779|Primary|Mean Change From Baseline in Fasting Non-High Density Lipoprotein (HDL) Cholesterol Associated With RETN_097|The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted (adj) p-values were calculated for each phenotype-genotype pair.|Baseline (Day 1), Week 48, and Week 96.|Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.||mg/dL||Standard Error|Mean
717143|NCT00272779|Secondary|Mean Change From Baseline in BMI at Week 96|Mean change From baseline in BMI at Week 96 was determined.|Baseline (Day 1) and Week 96|As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy, and with values for this parameter.||kg/m^2||Standard Error|Mean
717144|NCT00272779|Secondary|Mean Changes From Baseline in Body Weight at Week 96|Mean change in body weight from baseline was determined.|Physical examination was performed at Baseline (Day 1) and Weeks 48 and 96.|As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy, and who had values for this parameter.||kg||Standard Error|Mean
717145|NCT00272779|Secondary|Percentage of Participants With Lipoatrophy at Week 96|Lipoatrophy, redistribution of body fat was defined as >= 20% decrease in limb fat. The percentage of participants with lipoatrophy from baseline was determined.|Baseline (Day 1) and Week 96|As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy, and who had values for this parameter.||percentage of participants|||Number
717146|NCT00272779|Secondary|Mean Change From Baseline in Waist-to-hip-ratio at Week 48|Mean change from baseline in waist-to-hip-ratio at Week 48 was determined.|Baseline (Day 1) and Week 48|As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy, and who had values for this parameter.||ratio||Standard Error|Mean
717147|NCT00272779|Secondary|Mean Change From Baseline in BMI at Week 48|Mean change from baseline in BMI at Week 48 was determined.|Baseline (Day 1) and Week 48.|As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy, and who had values for this parameter.||kg/m^2||Standard Error|Mean
717148|NCT00272779|Secondary|Mean Change From Baseline in Waist-to-hip-ratio at Week 96|Mean change from baseline in waist-to-hip-ratio at Week 96 was determined.|Baseline (Day 1) and Week 96|As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy, and who had values for this parameter.||ratio||Standard Error|Mean
717149|NCT00272779|Secondary|Mean Change From Baseline in Waist Circumference at Week 48|Mean change from baseline in waist circumference at Week 48 was determined.|Baseline (Day 1) and Week 48|As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy, and who had values for this parameter.||cm||Standard Error|Mean
717150|NCT00272779|Secondary|Mean Change From Baseline in Waist Circumference at Week 96|Mean change From baseline in waist circumference at Week 96 was determined.|Baseline (Day 1) and Week 96.|As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy, and who had values for this parameter.||cm||Standard Error|Mean
717151|NCT00272779|Secondary|Mean Change From Baseline in BMI at Week 96||Baseline (Day 1) and Week 96|Safety analyses of the treatment period are based on treated population with values for this parameter.||kg/m^2||Standard Error|Mean
717152|NCT00272779|Secondary|Mean Change From Baseline in Body Weight at Week 48|Mean change from baseline in body weight at Week 48 was determined.|Baseline (Day 1) and Week 48|As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy, and who had values for this parameter.||kg||Standard Error|Mean
717153|NCT00272779|Secondary|Mean Change From Baseline in Body Weight at Week 96|Mean change from baseline in weight at Week 96|Baseline (Day 1) and Week 96|Safety analyses of the treatment period are based on treated population with values for this parameter.||kg||Standard Error|Mean
717154|NCT00272779|Secondary|Mean Percent Changes From Baseline in BMD Measured by DEXA at Week 96|Mean percent change from baseline in BMD of arms, legs, trunk and total body was measured using DEXA, an X-ray scan technique.|Baseline (Day 1) and Week 96|As-treated participants in the lipodystrophy substudy who participated in the substudy and signed the informed consent for the substudy.||g/cm^2||95% Confidence Interval|Mean
717155|NCT00272779|Secondary|Mean Percent Changes From Baseline in Bone Mineral Density (BMD) Measured by DEXA at Week 48|Mean percent change from baseline in BMD of arms, legs, trunk and total body was measured using DEXA, an X-ray scan technique.|DEXA scans were taken at Baseline (Day 1) and Week 48.|As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy.||grams/ centimeters ^2 (g/cm^2)||95% Confidence Interval|Mean
717156|NCT00272779|Secondary|Median Changes From Baseline at Week 96 in VAT-to-TAT, VAT-to-SAT and, Trunk-to-limb Fat Ratio Measured by Computed Tomography (CT)/DEXA||Baseline (Day 1) and Week 96.|As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy.||Ratio||95% Confidence Interval|Mean
717157|NCT00272779|Secondary|Mean Percent Changes From Baseline in Limb, Trunk and Total Body Fat Measured by DEXA at Week 96|The mean percent change from baseline in limb, trunk and total body fat was measured by DEXA. Limb fat: a physical sign of lipoatrophy, clinical improvement in limb fat is associated with a decrease in values. Trunk fat: physical sign of lipohypertrophy, clinical improvement in trunk fat is associated with a decrease in values. Total body fat: association of many factors like trunk fat, limb fat, weight etc. Clinical improvement in total body fat cannot be predicted based solely an increase or decrease of these values.|Baseline (Day 1) and Week 96.|As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy.||Percentage||95% Confidence Interval|Mean
717171|NCT00272779|Primary|Cmax of RTV at Week 4|Cmax was derived from plasma concentration versus time data.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.|All participants who completed the intensive PK study.||ng/mL||Full Range|Geometric Mean
717392|NCT00273754|Secondary|Extubation Time.|Time from end of anesthesia until extubation.|Duration from anesthesia end until extubation time.|||minutes||Standard Deviation|Mean
717158|NCT00272779|Secondary|Mean Percent Changes From Baseline in Limb, Trunk and Total Body Fat Measured by DEXA at Week 48|The mean percent change from baseline in limb, trunk and total body fat was measured by DEXA. Limb fat: a physical sign of lipoatrophy, clinical improvement in limb fat is associated with a decrease in values. Trunk fat: a physical sign of lipohypertrophy, clinical improvement in trunk fat is associated with a decrease in values. Total body fat: association of many factors like trunk fat, limb fat, weight etc. Clinical improvement in total body fat cannot be predicted based solely an increase or decrease of these values.|DEXA scans were performed at baseline (within 30 days of starting study treatment), and at Weeks 48.|As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy.||Percentage||95% Confidence Interval|Mean
717159|NCT00272779|Secondary|Mean Change From Baseline in Trunk-to-limb Fat Ratio Measured by DEXA at Week 48|Mean changes from baseline in trunk-to-limb fat ratio as measured by DEXA, an x-ray scan used to measure bone mineral density. Clinical improvement was associated with a decrease in values.|DEXA scans were taken at Baseline (Day 1) and at Weeks 48.|As-treated participants (with values for this parameter)in the lipodystrophy substudy who participated in the substudy and signed the informed consent for the substudy.||Ratio||Standard Error|Mean
717160|NCT00272779|Secondary|Number of Participants With Virologic Failure Showing Treatment Emergent Resistance Through Week 96|Virologic failure participants defined as participants who were never suppressed (HIV RNA < 400 c/mL) and on study through Week 48, or who rebounded to HIV RNA ≥ 400 c/mL, and those who discontinued due to insufficient viral load response using CVR (NC=F). IAS-USA=International AIDS Society-United States of America, PI=protease inhibitor, RTI=reverse transcription inhibitor, TAMS=Thymidine Analogue-Associated Mutations, NRTI=non-nucleotide reverse transcriptase inhibitor, M184/V= Methionine-to-valine mutation at position 184 (in reverse transcription [RT] gene), FC=fold change|Baseline (Day 1) and Week 96.|"Resistance analysis are based on randomized population. 2 subjects with baseline phenotypic resistance to ATV/RTV are excluded. Paired baseline and on-study HIV samples tested for genotypic resistance and phenotypic resistance. n signifies the number of participants evaluable for each parameter."||Participants|||Number
717161|NCT00272779|Secondary|Number of Participants With Laboratory Abnormalities in Urinalysis Through Week 96|Laboratory measurements marked as abnormal, per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe), at any study time point. The following Grade 3 and 4 definitions specify the criteria for MAs in urinalysis: Proteinuria: Grade 3: 4= or >2-3.5 g loss/day, Grade 4: >3.5 g loss/day.|At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.|Safety analyses of the treatment period are based on treated population.||Participants|||Number
717162|NCT00272779|Secondary|Number of Participants With Laboratory Abnormalities in Fasting Glucose Levels Through Week 96|Laboratory measurements marked as abnormal, per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe), at any study time point. The following Grade 3 and 4 definitions specify the criteria for MAs in fasting glucose: hypoglycemia: Grade 3: 30-39 mg/dL, Grade 4: <30 mg/dL; hyperglycemia: 251-500 mg/dL, Grade 4: >500 mg/dL.|At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.|Safety analyses of the treatment period are based on treated population.||Participants|||Number
717163|NCT00272779|Secondary|Number of Participants With Laboratory Abnormalities in Fasting Lipids Level Through Week 96|Laboratory measurements marked as abnormal, as per NCEP-ATP-III guided categories. The following definitions specify the criteria for MAs in fasting lipids: Total cholesterol: Grade 3: 240 - 300 mg/dL, Grade 4: >=240 mg/dL, triglycerides: Grade 3: 200 - <500 mg/dL, Grade 4: >=500 mg/dL.|At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.|Safety analyses of the treatment period are based on treated population.||Participants|||Number
717164|NCT00272779|Primary|Number of Participants With Single Nucleotide Polymorphisms (SNPs) Included in Genotype-Phenotype Analysis|19 genes of interest were selected from previous results or literature, and 34 SNPs were genotyped. Phenotype-Genotype analysis was performed using 31 of the SNPs. The genotypes of each SNP were further classified as either a minor allele carrier (MAC) group composed of heterozygous and rare homozygous genotypes, or wild type [WT, common homozygous].|Baseline visit|Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. The Hardy-Weinberg Equilibrium test was used to check for the genotype quality. All SNPs passed the quality check.||participants|||Number
717165|NCT00272779|Primary|Mean Change From Baseline in Trunk-to-Limb Fat Ratio as Measured by Dual Energy X-ray Absorptiometry (DEXA) at Week 96|Mean changes from baseline in trunk-to-limb fat ratio as measured by DEXA, an x-ray scan used to measure bone mineral density. Clinical improvement is associated with a decrease in values.|Baseline (Day 1) and Week 96.|As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy.||Ratio||Standard Error|Mean
717166|NCT00272779|Primary|AUC (TAU) of Tenofovir at Week 4|AUC (TAU) was derived from plasma concentration versus time data.It was calculated from time 0-24 hours for tenofovir in LPV/RPV and ATV/RTV regimen at Week 4.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.|All participants who completed the intensive PK study.||ng*h/mL||Full Range|Geometric Mean
717167|NCT00272779|Primary|Cmin of Tenofovir at Week 4|Cmin was derived from plasma concentration versus time data.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.|All participants who completed the intensive PK study.||ng/mL||Full Range|Geometric Mean
717168|NCT00272779|Primary|Cmax of Tenofovir at Week 4|Cmax was derived from plasma concentration versus time data.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.|All participants who completed the intensive PK study.||ng/mL||Full Range|Geometric Mean
717169|NCT00272779|Primary|Cmin of RTV at Week 4|Cmin was derived from plasma concentration versus time data.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.|All participants who completed the intensive PK study.||ng/mL||Full Range|Geometric Mean
717429|NCT00276094|Primary|Mean Change From Baseline in Percentage of Parabasal Cells in Maturation Index of Vaginal Smear||Baseline (Screening) to Week 12|||percentage of parabasal cells||Standard Deviation|Mean
717172|NCT00272779|Primary|Inhibitory Quotient (IQ) of ATV and LPV When Dosed With RTV at Week 4|IQ defined as Cmin at week 4 divided by protein binding adjusted EC90 values for the respective protease inhibitor (ATV or LPV) derived from individual participant clinical isolates.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.|All participants who completed the intensive PK study.||ng/mL||Full Range|Geometric Mean
717173|NCT00272779|Primary|Protein Binding Adjusted Effective Concentration (EC-90) of ATV and LPV When Dosed With RTV at Week 4|EC90/50=concentration of drug inducing 90%/50% of its maximal response. Protein binding adjusted EC90 for ATV and LPV were derived from phenotypically measured individual EC50 values at baseline using the following formula: Protein binding adjusted EC90 (ng/mL) = scale factor × molecular weight of the free base × EC50 micrometer(μM)/ unbound fraction (fu). Scale factor relates EC50 to EC90 (value of 3 and 2 for ATV and LPV, respectively); fu: estimated unbound fraction of ATV and LPV in vivo (0.14 and 0.02 for ATV and LPV respectively).|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.|All participants who completed the intensive PK study.||ng/mL||Full Range|Geometric Mean
717174|NCT00272779|Primary|Terminal Elimination Half-life (T-half) of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4|T-half was derived from the plasma concentration versus time data.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.|All participants who completed the intensive PK study.||Hr||Standard Deviation|Mean
717175|NCT00272779|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4|Tmax was derived from the plasma concentration versus time data.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.|All participants who completed the intensive PK study.||Hr||Full Range|Median
717176|NCT00272779|Primary|Minimum Plasma Concentration (Cmin) of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4|Cmin was derived from the plasma concentration versus time data.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.|All participants who completed the intensive PK study.||ng/mL||Full Range|Geometric Mean
717177|NCT00272779|Primary|Area Under the Concentration-time Curve, in One Dosing Interval [AUC(TAU)] of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4|AUC(TAU) was derived from the plasma concentration versus time data. It was calculated from time 0 to 12 hours for LPV and RTV in the LPV/RTV regimen, 0-24 hours for ATV and RTV in the ATV/RTV regimen, and 0-24 hours for tenofovir in both regimens at Week 4.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.|All participants who completed the intensive PK study.||ng*h/mL||Full Range|Geometric Mean
717178|NCT00272779|Secondary|Number of Participants With Laboratory Abnormalities in Electrolytes Level Through Week 96|Serum electrolytes abnormalities,graded per modified WHOcriteria.Ranges were:hypercarbia:Grade3:41-45milliequivalents(meq)/L,Grade4:>45meq/L;hypocarbia:Grade3:10-14 meq/L,Grade4:<10 meq/L;hypercalcemia:Grade3:12.6 – 13.5 mg/dL,Grade 4:>13.5 mg/dL;hypocalcemia:6.1–6.9mg/dL,Grade4:<6.1mg/dL;hyperchloremia:Grade 3: 121-125 meq/L,Grade4:>125meq/L;hypochloremia:Grade 3:80-84 meq/L,Grade4:<80meq/L;hyperkalemia:Grade3:6.6-7.0meq/L,Grade4:>7.0meq/L;hypokalemia:Grade3:2.0-2.4 meq/L,Grade4:<2.0meq/L;hypernatremia:Grade3:158-165 meq/L,Grade4:>165meq/L;hyponatremia:Grade 3:116-122 meq/L,Grade 4:115 meq/L.|At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.|Safety analyses of the treatment period are based on treated population.||Participants|||Number
717179|NCT00272779|Secondary|Number of Participants With Laboratory Abnormalities in Renal Function Test Through Week 96|Renal function test abnormalities were graded as per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe). Grade 3 and 4 criteria were: BUN: Grade 3: 5.1- 10*ULN, Grade 4: >10*ULN; Creatinine: Grade 3: 3.1 - 6*ULN, Grade 4: >6*ULN; low phosphorous (hypophosphatemia): Grade 3: 1.0- 1.4 mg/dL, Grade 4: <1.0mg/dL; high uric acid (hyperuricemia): Grade 3: 12.1 – 15.0 mg/dL, Grade 4: >15.0 mg/dL.|At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.|Safety analyses of the treatment period are based on treated population.||Participants|||Number
717180|NCT00272779|Secondary|Number of Participants With Laboratory Abnormalities in Liver Function Test Through Week 96|Liver function tests abnormalities were graded as per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe), while albumin was graded as per NCI-CTCAE. Grade 3 and 4 criteria were: ALT, AST, alkaline phosphatase: Grade 3: 5.1- 10*ULN, Grade 4: >10*ULN; direct and total bilirubin: Grade 3: 2.6- 5*ULN, Grade 4: >5*ULN, Albumin: Grade 3: <2g/dL.|At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.|Safety analyses of the treatment period are based on treated population. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.||Participants|||Number
717181|NCT00272779|Secondary|Number of Participants With Laboratory Abnormalities in Serum Enzyme Levels Through Week 96|Laboratory measurements marked as abnormal, as per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe). Grade 3 and 4 criteria in serum enzymes were: CPK: Grade 3: 5.1 – 10.0 * ULN, Grade 4: >10* ULN; Lipase: Grade 3: 2.10 – 5.0* ULN, Grade 4: 5.0* ULN.|At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.|Safety analyses of the treatment period are based on treated population.||Participants|||Number
717215|NCT00272779|Secondary|Number of Participants With Confirmed Plasma HIV RNA < 400 c/mL at Week 48 (Defined by the Food and Drug Administration [FDA] Time to Loss of Virologic Response [TLOVR] Algorithm)|TLOVR defines responders at Week 48 as participants with confirmed HIV RNA <400 c/mL through Week 48 without intervening virologic rebound or treatment discontinuation. Virologic rebound is defined as confirmed on-treatment HIV RNA <400 c/mL or last on-treatment HIV RNA <400 c/mL followed by discontinuation. Participants are considered failures in this analysis if they experienced virologic rebound at or before Week 48, discontinued before Week 48, never responded by Week 48, never received study therapy or had missing HIV RNA at Week 48 and beyond.|Baseline (Day 1) and Week 48|Efficacy analyses of the treatment period are based on randomized population.||Participants|||Number
717182|NCT00272779|Secondary|Number of Participants With Laboratory Abnormalities in Hematology: Hemoglobin, Hematocrit, Platelet Count, INR, Neutrophils, PT and WBC Through Week 96|Hematology abnormalities were graded per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe). Grade 3 and 4 criteria were: Hemoglobin: Grade 3: 6.5-7.9 g/dL, Grade 4: <6.5 g/dL; Hematocrit: Grade 3: >=19.5 – 24%, Grade 4: <19.5%; platelet count: Grade 3: 20,000- 49, 999/ mm^3, Grade 4: <20,000/mm^3; INR: Grade 3 Absolute Neutrophil Count (ANC): Grade 3: >= 500 - <750/mm^3, Grade 4: <500/mm^3; PT: Grade 3: 1.51 – 3.0*ULN, Grade 4: >3*ULN; WBC: Grade 3: >=800 to <1000/mm^3, Grade 4: <80/mm^3.|At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.|Safety analyses of the treatment period are based on treated population. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.||Participants|||Number
717183|NCT00272779|Secondary|Mean Changes in Fasting Insulin at Week 96|Mean change from baseline in fasting insulin at Week 96.|Baseline (Day 1) and Week 96.|Safety analyses of the treatment period are based on treated population with values for this parameter.||µU/mL||Standard Error|Mean
717184|NCT00272779|Secondary|Mean Changes in Fasting Glucose at Week 96|Mean change from baseline in fasting glucose at Week 96 was determined.|Baseline (Day 1) and Week 96|Safety analyses of the treatment period are based on treated population with values for this parameter.||mg/dL||Standard Error|Mean
717185|NCT00272779|Primary|Maximum Plasma Concentration (Cmax) of ATV/RTV and LPV/RTV in the Presence of an Antiretroviral (ARV) Regimen Including TDF at Week 4|Cmax was derived from plasma concentration versus time data.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given every day (QD) and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given twice daily (BID) and TDF given QD.|All participants who completed the intensive pharmacokinetic (PK) study.||nanogram(ng)/mL||Full Range|Geometric Mean
717186|NCT00272779|Secondary|Mean Changes in Fasting Lipids at Week 96|Mean change from baseline in fasting lipids at Week 96 was determined.|At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.|Safety analyses of the treatment period are based on treated population.||mg/dL||Standard Error|Mean
717187|NCT00272779|Secondary|Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Experienced Adverse Events (AEs) and Experienced Events Leading to Discontinuation Through Week 96|AEs:new,untoward medical occurrences/worsening of pre-existing medical condition,drug-related or not.SAEs:any AE that:resulted in death;was life threatening;resulted in a persistent or significant disability/incapacity;resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; was cancer;or overdose.Discontinuation from study was due either to an AE or was conducted at the investigator's discretion.AEs represented here include SAEs, which are not included in the AE count represented in the AE xml upload section. As such, these numbers may not match.|From Day 1 through Week 96|Safety analyses of the treatment period are based on treated population.||Participants|||Number
717188|NCT00272779|Secondary|Mean Change From Baseline in CD4 Cell Count at Week 96|Mean change from baseline in CD4 count among treated participants was determined.|Baseline (Day 1) and Week 96|Efficacy analyses of the treatment period are based on as-randomized population with values for this parameter.||cells/mm^3||Standard Error|Mean
717189|NCT00272779|Secondary|Reduction of log10 HIV RNA Levels From Baseline at Week 96|Changes from baseline in log10 HIV RNA levels were calculated.|Baseline (Day 1) and Week 96|Efficacy analyses of the treatment period are based on as-randomized population with values for this parameter. log10 HIV RNA changes from baseline were summarized at Week 96 using observed values.||c/mL||Standard Error|Mean
717190|NCT00272779|Secondary|Number of Participants With HIV RNA < 400 c/mL) at Week 96|HIV RNA <400 c/mL is a less stringent measure of viral suppression (highest threshold of assay) and indicates that a participant has responded to treatment.|Baseline (Day 1) and Week 96|Efficacy analyses of the treatment period are based on randomized population. In this analysis, participants who did not complete the study are counted as having failed to respond to treatment. Participants who discontinued prior to obtaining Week 96 HIV RNA levels were categorized under Non-completers.||Participants|||Number
717191|NCT00272779|Secondary|Number of Participants With HIV RNA < 50 c/mL) at Week 96|HIV RNA < 50 c/mL is the most stringent measure of viral suppression (lowest threshold of assay) and indicates that a participant has responded to treatment.|Baseline (Day 1) and Week 96|Efficacy analyses of the treatment period are based on randomized population. In this analysis, participants who did not complete the study are counted as having failed to respond to treatment. Participants who discontinued prior to obtaining Week 96 HIV RNA levels were categorized under Non-completers.||Participants|||Number
717192|NCT00272779|Secondary|Number of Participants Who Adhered to Regimen as Measured by Multicenter AIDS Cohort Study Adherence Questionnaire (MACS) at Week 48|The MACS adherence questionnaire asks patients how many medication doses they missed during the previous day, 2 days, 3 days and 4 days. Adherence to regimen was defined as taking 100% of medicine (all doses and numbers of pills as prescribed for each medicine). This strict adherence cut-off was based on the guidelines stating that anything less than excellent adherence may result in a virus breakthrough and development of resistance.|Week 48|The 'n' is signifying those participants who were evaluated for this measure at the timepoint for each group respectively.||Participants|||Number
717193|NCT00272779|Secondary|Mean Change From Baseline in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 24 Using the Irritable Bowel Syndrome Quality of Life (IBS-QoL)|The IBS-QoL questionnaire has 34 items and an overall score and 8 subscale scores: dysphoria,interference with activity,body image,health worry, food avoidance,social reaction,sexual, and relationships. Overall and subscores transformed to a 0-100 scale (0=lowest score, 100=highest possible score). Scores between these values represent the percentage of the total possible score achieved. Higher scores=better IBS-related QoL. A 14-point change from BL in IBS-QoL score in women with moderate to severe functional bowel disorders is a minimally important difference based on pain and satisfaction.|Baseline (Day 1) and Week 24|As treated participants with evaluable baseline IBS-QOL. The 'n' is signifying those participants were evaluated for this measure at the timepoint for each group respectively.||Units on a scale||Standard Error|Mean
717389|NCT00273754|Secondary|Hospital Discharge Time|Children were discharged from the hospital when they reached the hospital discharge criteria: they were awake, had stable vital signs, were breathing adequately, had O2 saturation >95% while breathing room air, were able to swallow fluids, had no or minimal pain, and were able to ambulate without excessive nausea, vomiting, or dizziness.|Total time from end anesthesia to discharge home|||Minutes||Standard Deviation|Mean
717194|NCT00272779|Secondary|Mean Change From Baseline in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 12 (IBS-QoL)|The IBS-QoL questionnaire has 34 items and an overall score and 8 subscale scores: dysphoria,interference with activity,body image,health worry, food avoidance,social reaction,sexual, and relationships. Overall and subscores transformed to a 0-100 scale (0=lowest score, 100=highest possible score). Scores between these values represent the percentage of the total possible score achieved. Higher scores=better IBS-related QoL. A 14-point change from BL in IBS-QoL score in women with moderate to severe functional bowel disorders is a minimally important difference based on pain and satisfaction.|IBS-QoL is administered at baseline (Day 1) and Week 12.|As treated participants with evaluable baseline IBS-QOL. The 'n' is signifying those participants were evaluated for this measure at the timepoint for each group respectively.||Units on Scale||Standard Error|Mean
717195|NCT00272779|Secondary|Mean Change From Baseline (BL) in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 4 (IBS-QoL)|The IBS-QoL questionnaire has 34 items and an overall score and 8 subscale scores: dysphoria,interference with activity,body image,health worry, food avoidance,social reaction,sexual, and relationships. Overall and subscores transformed to a 0-100 scale (0=lowest score, 100=highest possible score). Scores between these values represent the percentage of the total possible score achieved. Higher scores=better IBS-related QoL. A 14-point change from BL in IBS-QoL score in women with moderate to severe functional bowel disorders is a minimally important difference based on pain and satisfaction.|IBS-QoL is administered at baseline (Day 1) and Week 4.|As treated participants with evaluable baseline IBS-QOL. The 'n' is signifying those participants were evaluated for this measure at the timepoint for each group respectively.||Units on Scale||Standard Error|Mean
717196|NCT00272779|Secondary|Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey - Human Immunodeficiency Virus (MOS-HIV) at Week 48|MOS-HIV is developed to assess a participant's health and functional status associated with HIV infection. The questionnaire is applied to participants with adequate linguistic skills and consists of 35 items. The questionnaire derives an overall health score and 10 subscale scores (health transitions, pain, physical functioning, role functioning, social functioning, cognitive functioning, mental health, energy/fatigue, health distress and quality of life).The subscale and summary scores range from 0-100 with a higher score indicating better health.|Baseline (Day 1) and Week 48|Participants analyzed are as-treated participants with evaluable baseline MOS-HIV. The 'n' is signifying those participants who were evaluated for this measure at the timepoint for each group respectively.||Units on Scale||Standard Error|Mean
717197|NCT00272779|Secondary|Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey - Human Immunodeficiency Virus (MOS-HIV) at Week 24|Medical Outcomes Study HIV Health Survey (MOS-HIV) is developed to assess a patient's health and functional status associated with HIV infection. The MOS-HIV questionnaire is applied to participants with adequate linguistic skills. The subscale and summary scores range from 0-100 with a higher score indicating better health.|Baseline (Day 1) and Week 24.|As-treated participants with evaluable baseline MOS-HIV . The 'n' is signifying those participants who were evaluated for this measure at the timepoint for each group respectively.||Units on Scale||Standard Error|Mean
717198|NCT00272779|Secondary|Mean Change in Fasting Insulin at Week 48|Mean change from baseline in fasting insulin at Week 48.|Baseline (Day 1) and Week 48.|Safety analyses of the treatment period are based on treated population with values for this parameter.||micro units (µU)/mL||Standard Error|Mean
717199|NCT00272779|Secondary|Mean Change in Fasting Glucose at Week 48|Mean change from baseline in fasting glucose at Week 48.|Baseline (Day 1) and Week 48.|Safety analyses of the treatment period are based on treated population with values for this parameter.||mg/dL||Standard Error|Mean
717200|NCT00272779|Secondary|Mean Change in Fasting Lipid at Week 48|Mean change from baseline in fasting lipids, for fasting total cholesterol, LDL cholesterol, HDL cholesterol, non-HDL cholesterol, and triglycerides at Week 48 were determined.|Baseline (Day 1) and Week 48.|Safety analyses of the treatment period are based on treated population.||milligrams/deciliter (mg/dL)||Standard Error|Mean
717201|NCT00272779|Secondary|Mean Change in Body Mass Index (BMI) in Participants at Week 48|Mean change in BMI from baseline at Week 48 was determined.|Baseline (Day 1) and Week 48|Safety analyses of the treatment period are based on treated population, who had values for this parameter.||kg/m^2||Standard Error|Mean
717202|NCT00272779|Secondary|Mean Change in Weight From Baseline at Week 48|Mean change in body weight from baseline was determined.|Baseline (Day 1) and Week 48|Safety analyses of the treatment period are based on treated population, who had values for this parameter.||kg||Standard Error|Mean
717203|NCT00272779|Secondary|Number of Participants With Laboratory Abnormalities in Fasting Glucose Through Week 48|Laboratory measurements marked as abnormal, per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe), at any study time point. The following Grade 3 and 4 definitions specify the criteria for MAs in fasting glucose: hypoglycemia: Grade 3: 30-39 mg/dL, Grade 4: <30 mg/dL; hyperglycemia: 251-500 mg/dL, Grade 4: >500 mg/dL.|At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.|Safety analyses of the treatment period are based on treated population. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.||Participants|||Number
717204|NCT00272779|Secondary|Number of Participants With Laboratory Abnormalities in Fasting Lipids Through Week 48|Laboratory measurements marked as abnormal, as per National Cholesterol Education Program (NCEP)- Adult Treatment Panel (ATP)-III guided categories. The following definitions specify the criteria for MAs in fasting lipids: Total cholesterol: Grade 3: 240 - 300 mg/dL, Grade 4: >=240 mg/dL, triglycerides: Grade 3: 200 - <500 mg/dL, Grade 4: >=500 mg/dL.|At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.|Safety analyses of the treatment period are based on treated population. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.||Participants|||Number
717205|NCT00272779|Secondary|Number of Participants With Laboratory Abnormalities in Urinalysis Through Week 48|Laboratory measurements marked as abnormal, per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe), at any study time point. The following Grade 3 and 4 definitions specify the criteria for MAs in urinalysis: Proteinuria: Grade 3: 4= or >2-3.5 g loss/day, Grade 4: >3.5 g loss/day.|At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.|Safety analyses of the treatment period are based on treated population. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.||Participants|||Number
717206|NCT00272779|Secondary|Number of Participants With Laboratory Abnormalities in Electrolytes Through Week 48|Serum electrolytes abnormalities,graded per modified WHOcriteria.Ranges were:hypercarbia:Grade3:41-45milliequivalents(meq)/L,Grade4:>45meq/L;hypocarbia:Grade3:10-14 meq/L,Grade4:<10 meq/L;hypercalcemia:Grade3:12.6 – 13.5 mg/dL,Grade 4:>13.5 mg/dL;hypocalcemia:6.1–6.9mg/dL,Grade4:<6.1mg/dL;hyperchloremia:Grade 3: 121-125 meq/L,Grade4:>125meq/L;hypochloremia:Grade 3:80-84 meq/L,Grade4:<80meq/L;hyperkalemia:Grade3:6.6-7.0meq/L,Grade4:>7.0meq/L;hypokalemia:Grade3:2.0-2.4 meq/L,Grade4:<2.0meq/L;hypernatremia:Grade3:158-165 meq/L,Grade4:>165meq/L;hyponatremia:Grade 3:116-122 meq/L,Grade 4:115 meq/L.|At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.|Safety analyses of the treatment period are based on treated population. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.||Participants|||Number
717207|NCT00272779|Secondary|Number of Participants With Laboratory Abnormalities in Renal Function Test Through Week 48|Renal function test abnormalities were graded as per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe). Grade 3 and 4 criteria were: Blood urea nitrogen (BUN): Grade 3: 5.1- 10*ULN, Grade 4: >10*ULN; Creatinine: Grade 3: 3.1 - 6*ULN, Grade 4: >6*ULN; low phosphorous (hypophosphatemia): Grade 3: 1.0- 1.4 mg/dL, Grade 4: <1.0mg/dL; high uric acid (hyperuricemia): Grade 3: 12.1 – 15.0 mg/dL, Grade 4: >15.0 mg/dL.|At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, and 48.|Safety analyses of the treatment period are based on treated population. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.||Participants|||Number
717208|NCT00272779|Secondary|Number of Participants With Laboratory Abnormalities in Liver Function Test Through Week 48|Liver function tests abnormalities were graded as per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe), while albumin was graded as per National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE). Grade 3 and 4 criteria were: alanine aminotransferase (ALT), aspartate aminotransferase(AST), alkaline phosphatase: Grade 3: 5.1- 10*ULN, Grade 4: >10*ULN; direct and total bilirubin: Grade 3: 2.6- 5*ULN, Grade 4: >5*ULN, Albumin: Grade 3: <2g/dL.|At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.|Safety analyses of the treatment period are based on treated population. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.||Participants|||Number
717209|NCT00272779|Secondary|Number of Participants With Laboratory Abnormalities in Serum Enzymes Levels Through Week 48|Laboratory measurements marked as abnormal, as per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe). Grade 3 and 4 criteria in serum enzymes were: Creatine phosphokinase (CPK): Grade 3: 5.1 – 10.0 * upper limit of normal (ULN), Grade 4: >10* ULN; Lipase: Grade 3: 2.10 – 5.0* ULN, Grade 4: 5.0* ULN.|At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.|Safety analyses of the treatment period are based on treated population.The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.||Participants|||Number
717210|NCT00272779|Secondary|Number of Participants With Laboratory Abnormalities in Hematology Through Week 48: Hemoglobin, Hematocrit, Platelet Count, International Normalized Ratio (INR), Neutrophils, Prothrombin Time (PT) and White Blood Cells (WBC)|Hematology abnormalities were graded per modified World Health Organization (WHO) criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe). Grade 3 and 4 criteria were: Hemoglobin: Grade 3: 6.5-7.9 g/dL, Grade 4: <6.5 g/dL; Hematocrit: Grade 3: >=19.5 – 24%, Grade 4: <19.5%; platelet count: Grade 3: 20,000- 49, 999/ mm^3, Grade 4: <20,000/mm^3; INR: Grade 3 Absolute Neutrophil Count (ANC): Grade 3: >= 500 - <750/mm^3, Grade 4: <500/mm^3; PT: Grade 3: 1.51 – 3.0*ULN, Grade 4: >3*ULN; WBC: Grade 3: >=800 to <1000/mm^3, Grade 4: <80/mm^3.|At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.|Safety analyses of the treatment period are based on treated population. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.||Participants|||Number
717211|NCT00272779|Secondary|Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Experienced Adverse Events (AEs) and Experienced AEs Leading to Discontinuation Through Week 48|AEs:new,untoward medical occurrences/worsening of pre-existing medical condition,drug-related or not.SAEs:any AE that:resulted in death;was life threatening;resulted in a persistent or significant disability/incapacity;resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; was cancer;or overdose.Discontinuation from study was due either to an AE or was conducted at the investigator's discretion.AEs represented here include SAEs, which are not included in the AE count represented in the AE xml upload section. As such, these numbers may not match.|From baseline (Day 1) to Week 48.|Safety analyses of the treatment period are based on treated population.||Participants|||Number
717212|NCT00272779|Secondary|Treatment Emergent Resistance in Isolates From Participants With Virologic Failure at Week 48|Participants with virologic failure are those who never suppressed (HIV RNA <400 c/mL) and were on study through Week 48, or who rebounded to HIV RNA >= 400 c/mL and those who discontinued due to insufficient viral load response. IAS=International AIDS Society, PI=protease inhibitor, RTI=reverse transcription inhibitor, TAMS=Thymidine Analogue-Associated Mutations, NRTI=non-nucleotide reverse transcriptase inhibitor, M184V= Methionine-to-valine mutation at position 184 (in reverse transcription [RT] gene), FC=fold change|Baseline (Day 1) and Week 48|Paired baseline and on-study HIV samples tested for genotypic resistance and phenotypic resistance. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.||Participants|||Number
717213|NCT00272779|Secondary|Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 48|Mean change from baseline in CD4 cell counts was determined.|Baseline (Day 1) and Week 48.|All treated participants with data for this parameter.||c/mm^3||Standard Error|Mean
717214|NCT00272779|Secondary|Reduction of log10 HIV RNA Levels From Baseline to Week 48|Changes from baseline in log10 HIV RNA levels were calculated.|Baseline (Day 1) and Week 48|All treated participants with data for this parameter.||c/mL||Standard Error|Mean
717324|NCT00267098|Secondary|Change in Mitral Regurgitation From Randomization to 24 Months|The endpoint will be a subject's change in mitral regurgitation (a measure of how much blood flows backwards into the heart due to the mitral valve not closing properly). The measure for each subject will be the 24 month - randomization visit difference in mitral regurgitation. Negative values reflect reductions in mitral regurgitation over time.|Randomization to 24 Months|||percentage of left atrial area||Standard Deviation|Mean
717216|NCT00272779|Secondary|Number of Participants With HIV RNA < 400 c/mL at Week 48|HIV RNA < 400 c/mL is a less stringent measure of viral suppression (highest threshold of assay) and indicates that a participant responded to treatment.|Baseline (Day 1) and Week 48|Efficacy analyses of the treatment period are based on randomized population. In this analysis, participants who did not complete the study are counted as having failed to respond to treatment. Participants who discontinued prior to obtaining Week 48 HIV RNA levels were categorized under Non-completers.||Participants|||Number
717217|NCT00272779|Primary|Number of Participants With Human-immunodeficiency Virus- Ribonucleic Acid (HIV-RNA) < 50 Copies (c)/mL at Week 48|HIV RNA < 50 c/mL is the most stringent measure of viral suppression (lowest threshold of assay) and indicates that a participant responded to treatment.|Baseline (Day 1) and Week 48|Intent-to-treat (ITT) analysis. Participants received treatment assignment from the central randomization center. In this analysis, participants who did not complete the study were counted as having failed to respond to treatment. Participants who discontinued prior to obtaining Week 48 HIV RNA levels were categorized under non-completers.||Participants|||Number
717218|NCT00272792|Secondary|Change in Phenylalanine Levels From Baseline to Week 3||Baseline to Week 3|||umol/L||Standard Error|Mean
717219|NCT00272792|Primary|Amount of Dietary Supplemented Phenylalanine (Phe)Tolerated in Children With Phenylketonuria||at Week 10|||mg/kg/day||Standard Deviation|Mean
717220|NCT00272961|Secondary|Change From Pre-Dose to Post-Dose in Diastolic Blood Pressure (DBP) at Week 10|DBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart. A total of 3 measurements were performed and average was calculated at each time point in participant’s non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm). The same arm was used throughout the study.|Pre-Dose and 2 hours Post-Dose on Week 10|FAS:all randomized participants who received study treatment at least twice after Placebo Run-in Phase, but not necessarily at 2 consecutive visits. “N” (number of participants analyzed): participants evaluable for this measure.||mmHg||Standard Error|Least Squares Mean
717221|NCT00272961|Secondary|Change From Pre-Dose to Post-Dose in Systolic Blood Pressure (SBP) at Week 10|SBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. A total of 3 measurements were performed and average was calculated at each time point in participant’s non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm). The same arm was used throughout the study.|Pre-Dose and 2 hours Post-Dose on Week 10|FAS:all randomized participants who received study treatment at least twice after Placebo Run-in Phase, but not necessarily at 2 consecutive visits. “N” (number of participants analyzed): participants evaluable for this measure.||mmHg||Standard Error|Least Squares Mean
717222|NCT00272961|Secondary|Change From Standing to Sitting Diastolic Blood Pressure (DBP) at Week 10|DBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart. A total of 3 measurements were performed and average was calculated at each time point in participant’s non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm). The same arm was used throughout the study.|Pre-Dose and 2 hours Post-Dose on Week 10|FAS:all randomized participants who received study treatment at least twice after Placebo Run-in Phase, but not necessarily at 2 consecutive visits. “N” (number of participants analyzed): participants evaluable for this measure.||mmHg||Standard Error|Least Squares Mean
717223|NCT00272961|Secondary|Change From Standing to Sitting Systolic Blood Pressure (SBP) at Week 10|SBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. A total of 3 measurements were performed and average was calculated at each time point in participant’s non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm). The same arm was used throughout the study.|Pre-Dose and 2 hours Post-Dose on Week 10|FAS:all randomized participants who received study treatment at least twice after Placebo Run-in Phase, but not necessarily at 2 consecutive visits. “N” (number of participants analyzed): participants evaluable for this measure.||mmHg||Standard Error|Least Squares Mean
717224|NCT00272961|Secondary|Standing Diastolic Blood Pressure (DBP)|DBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart. A total of 3 measurements were performed and average was calculated at each time point in participant’s non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm) after participant stood for 2 minutes. The same arm was used throughout the study.|Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10|FAS: all randomized participants who received study treatment at least twice after Placebo Run-in Phase, but not necessarily at 2 consecutive visits. Here “N” (number of participants analyzed): participants evaluable for this measure, n: participants with non-missing value for specified time-point for each treatment arm, respectively.||mmHg||Standard Error|Mean
717225|NCT00272961|Secondary|Sitting Diastolic Blood Pressure (DBP)|DBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart. A total of 3 measurements were performed and average was calculated at each time point in participant’s non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm) after participant sat for 5 minutes for the first measurement and 2 minutes for second and third measurements. The same arm was used throughout the study.|Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10|FAS: all randomized participants who received study treatment at least twice after Placebo Run-in Phase, but not necessarily at 2 consecutive visits. Here “N” (number of participants analyzed): participants evaluable for this measure, n: participants with non-missing value for specified time-point for each treatment arm, respectively.||mmHg||Standard Error|Mean
717241|NCT00272987|Primary|Number of Events of Hepatotoxicity With the Indicated Characteristics|Events of hepatotoxicity are characterized as serious, related to investigational product, leading to withdrawal from the study and fatal. Participants could have been counted in more than one category.|From the date of the first dose of investigational product until 30 days after the last dose of investigational product (up to Study Week 164)|Safety Population. Only the participants with at least one of event of hepatotoxicity were analyzed.||Events of hepatotoxicity|||Number
717226|NCT00272961|Secondary|Standing Systolic Blood Pressure (SBP)|SBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. A total of 3 measurements were performed and average was calculated at each time point in participant’s non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm) after participant stood for 2 minutes. The same arm was used throughout the study.|Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10|FAS: all randomized participants who received study treatment at least twice after Placebo Run-in Phase, but not necessarily at 2 consecutive visits. Here “N” (number of participants analyzed): participants evaluable for this measure, n: participants with non-missing value for specified time-point for each treatment arm, respectively.||mmHg||Standard Error|Mean
717227|NCT00272961|Secondary|Sitting Systolic Blood Pressure (SBP)|SBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. A total of 3 measurements were performed and average was calculated at each time point in participant’s non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80 percent [%] of the arm) after participant sat for 5 minutes for the first measurement and 2 minutes for second and third measurements. The same arm was used throughout the study.|Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10|Full analysis set (FAS):all randomized participants who received study treatment at least twice after Placebo Run-in Phase, but not necessarily at 2 consecutive visits. “N” (number of participants analyzed): participants evaluable for this measure, n: participants with non-missing value for specified time-point for each treatment arm, respectively.||mmHg||Standard Error|Mean
717228|NCT00272961|Primary|Weighted Mean (Area Under Effect Curve [AUEC]) Blood Pressure Change|AUEC was calculated as the positive area under the change from baseline curve for sitting and standing SBP and DBP to Week 12, estimated by the linear trapezoidal rule corrected for the pre-dose baseline value. In the event that post-dose values returned below baseline at or before Week 12, then AUEC was calculated by setting the negative values to zero and taking only the positive area into account.|Baseline (Pre-Dose on Day 1 of Week 2) up to Week 12|Safety analysis set: all participants who received at least 1 dose of study treatment. “N”(number of participants analyzed): participants evaluable for this measure and n: participants with non-missing baseline and at least 2 non-missing values in treatment phase or in follow-up for specified category for each treatment arm, respectively.||mmHg||Standard Error|Least Squares Mean
717229|NCT00272961|Primary|Maximum Blood Pressure (BP) Increase|BP is the pressure of the blood within the arteries. It is produced primarily by the contraction of the heart muscle. BP measurement is recorded by 2 numbers: systolic BP (SBP, BP when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle) and diastolic BP (DBP, BP when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles). Maximum increase was calculated by subtracting baseline value from each post-dose measurement and selecting maximum of these values.|Baseline (Pre-Dose on Day 1 of Week 2) up to Week 12|Safety analysis set included all participants who received at least 1 dose of study treatment. Here “n” signifies participants evaluable for specified category for each treatment arm, respectively.||millimeter of mercury (mmHg)||Standard Error|Least Squares Mean
717230|NCT00272987|Secondary|Progression-free Survival as Assessed by the Investigator|Progression-free survival is defined as the time from randomization until the earliest date of disease progression or death due to any cause, if sooner. Disease progression was based on the investigator's assessments of the objective evidence (e.g., radiological scans and medical photographs). For participants who do not progress, or die, progression-free survival was censored at the time of the last investigator assessed radiological scan preceding the initiation of any alternative anti-cancer therapy. Progression-free survival was summarized using Kaplan-Meier curves.|From the date of the first dose of investigational product until the earlier of the date of disease progression or death due to any cause (up to Study Week 164)|Safety Population||Weeks||95% Confidence Interval|Median
717231|NCT00272987|Secondary|Number of Participants With Clinical Benefit (CR, PR, and Stable Disease [SD] for at Least 24 Weeks) as Assessed by Investigator|Clinical benefit is defined as the numer of participants achieving either a CR or PR or SD (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (at least a 20% increase in the sum of the LD of target lesions, taking as a reference, the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions), taking as reference, the smallest sum LD since the treatment started) for at least 24 weeks. This was based on confirmed responses from the investigator assessment of clinical benefit.|From the date of the first dose of investigational product until the first documented evidence of a PR or CR or SD until the earlier of the date of disease progression or the date of death due to breast cancer (up to Study Week 164)|Safety Population||Participants|||Number
717232|NCT00272987|Primary|Overall Response (OR): Percentage of Participants With a Best Overall Response (OR) of Confirmed Complete Response (CR) or Confirmed Partial Response (PR) as Assessed by the Investigator|OR is defined as the number of participants achieving either a CR or PR, per Response Evaluation Criteria in Solid Tumors (RECIST). The best OR is defined as the best response recorded from the start of treatment until progressive disease (PD)/recurrence. CR is defined as the disappearance of all target lesions (TLs) and non-TLs. PR is defined as at least a 30% decrease in the sum of the longest diameters (LD) of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL(s), as assessed by the IRC. PD is defined as at least a 20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-TLs. Responses were confirmed at subsequent assessments made >=28 days after the original response. Participants with an unknown or missing response are treated as non-responders.|From the date of the first dose of investigational product to the first documented evidence of a confirmed CR or PR (up to Study Week 164)|Safety Population||Percentage of participants|||Number
717233|NCT00272987|Secondary|Duration of Response (DoR), as Assessed by the Investigator|DoR is defined for the subset of participants who had a confirmed CR (disappearance of all TLs and non-TLs) or PR (>=30% decrease in the sum of the LD of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL[s]) as the time from the first documented evidence of a CR or PR until the first documentation of radiological PD or death due to breast cancer, if sooner. PD is defined as >=20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-TLs. For participants who did not progress or die, DoR was censored on the date of the last radiological scan. If a participant had only a Baseline visit or did not have a date of a radiological scan that was later than the date of initiation of anti-cancer therapy, DoR was censored at the start date of treatment.|From the first documented evidence of a PR or CR until the earlier of the date of disease progression or the date of death due to breast cancer (up to Study Week 164)|Safety Population. Only those participants with CR or PR were analyzed.||Weeks||Inter-Quartile Range|Median
717234|NCT00272987|Secondary|Time to Response as Assessed by the Investigator|Time to response is defined as the time from randomization until the first documented evidence of a PR or CR (whichever status is recorded first). Analysis was based on responses confirmed at a repeat assessment made at least 4 weeks after the initial response, with the time to response taken as the first time the response was observed, not the confirmation assessment. Participants who withdraw with no tumor response were censored at the date of withdrawal from the study. CR is defined as the disappearance of all TLs and non-TLs. PR is defined as at least a 30% decrease in the sum of the LD of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL(s). PD is defined as at least a 20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-TLs.|From the date of the first dose of investigational product until the first documented evidence of a PR or CR (up to Study Week 164)|Safety Population. Only those participants with CR or PR were analyzed.||Participants|||Number
717235|NCT00272987|Primary|Number of Participants Who Received Any Concomitant Medications During the Study Period|Number of participants who received any concomitant medication along with study drugs (lapatinib, trastuzumab and paclitaxel) were counted during the treatment period.|withdrawal/study completion (up to Study Week 164)|Safety Population||Participants|||Number
717236|NCT00272987|Primary|Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value|The Eastern Cooperative Oncology Group (ECOG) performance status scales and grades/criteria are used to assess how a participant's disease is progressing, to assess how the disease affects the daily living abilities of the participant, and to determine appropriate treatment and prognosis. Grade 0, fully active, able to carry on all pre-disease performance without restriction. Grade 1, restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. Grade 2, ambulatory and capable of all selfcare, but unable to carry out any work activities; up and about more than 50% of waking hours. Grade 3, capable of only limited selfcare; confined to bed or chair more than 50% of waking hours. Grade 4, completely disabled; cannot carry on any selfcare; totally confined to bed or chair. Grade 5, dead.|Baseline and every 4 weeks thereafter up to withdrawal/study completion and 30 day follow-up (up to Study Week 164)|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the safety population.||Participants|||Number
717237|NCT00272987|Primary|Number of Events of Left Ventricular Ejection Fraction Decrease With the Indicated Characteristics|Events of left ventricular ejection fraction (LVEF) decrease were characterized as serious, related to investigational product, leading to withdrawal from the study and fatal. A participant could have been counted in more than one category.|Baseline and every 8 weeks thereafter up to withdrawal/study completion and 30 day follow-up (up to Study Week 164)|Safety Population. Only the participants with at least one of event of LVEF decrease were analyzed.||Events|||Number
717238|NCT00272987|Primary|Change From Baseline in Body Temperature at the Indicated Time Points|Body temperature was measured at Baseline and every 4 weeks thereafter up to withdrawal/study completion and at the 30 day follow-up visit. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and every 4 weeks thereafter up to withdrawal/study completion and 30 day follow-up (up to Study Week 164)|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the safety population.||Degree Celsius||Standard Deviation|Mean
717239|NCT00272987|Primary|Change From Baseline in Heart Rate at the Indicated Time Points|Heart rate was measured at Baseline and every 4 weeks thereafter up to withdrawal/study completion and at the 30 day follow-up visit. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and every 4 weeks thereafter up to withdrawal/study completion and 30 day follow-up (up to Study Week 164)|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the safety population.||Beats per minute (BPM)||Standard Deviation|Mean
717240|NCT00272987|Primary|Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points|Blood pressure measurement included systolic blood pressure (SBP) and diastolic blood pressure (DBP) at Baseline and every 4 weeks thereafter up to withdrawal/study completion and at the 30 day follow-up visit. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and every 4 weeks thereafter up to withdrawal/study completion and 30 day follow-up (up to Study Week 164)|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the safety population.||Millimeter of mercury (mmHg)||Standard Deviation|Mean
717390|NCT00273754|Secondary|Post Anesthesia Care Unit (PACU) Duration||Time spent in PACU following surgical procedure prior to discharge home or hospital admission.|||minutes||Standard Deviation|Mean
717242|NCT00272987|Primary|Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters|Blood samples for clinical laboratory evaluation were taken at Baseline prior to the administration of investigational product and thereafter at each scheduled visit. Clinical chemistry parameters included values > upper limit of normal (ULN)=Hyper; values < lower limit of normal (LLN)=Hypo of sodium (Hypernatraemia and Hyponatraemia), potassium (Hyperkalaemia and Hypokalaemia), calcium (Hypercalcaemia and Hypocalcaemia), glucose (Hyperglycaemia and Hyperglycaemia), creatinine (if >2 milligram per deciliter [mg/dL]), aspartate aminotransferase (AST), alanine transaminase (ALT), alkaline phophatase, total bilirubin (if available bilirubin fractionation is recommended if the total bilirubin is > twice of ULN), and albumin. Clinical chemistry data was summarized by National Cancer Institute's Common toxicity criteria for adverse events (NCI CTCAE) toxicity grade (Version 3.0). Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling; Grade 5, death.|Baseline and every 4 weeks thereafter up to withdrawal/study completion and 30 day follow-up (up to Study Week 164)|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the safety population.||Participants|||Number
717243|NCT00272987|Primary|Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Hematology Parameters|Blood samples for clinical laboratory evaluation were taken at Baseline prior to the administration of investigational product and thereafter at each scheduled visit. Haematology parameters included haemoglobin, total white blood cell count (WBC), neutrophils, lymphocytes and platelets. Hematology data was summarized by the National Cancer Institute's Common toxicity criteria for adverse events (NCI CTCAE) toxicity grade (Version 3.0). Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling; Grade 5, death.|Baseline and every 4 weeks thereafter up to withdrawal/study completion and 30 day follow-up (up to Study Week 164)|Safety Population||Participants|||Number
717244|NCT00272987|Primary|Number of Events of Diarrhea With the Indicated Characteristics|Events of diarrhea are characterized as serious, related to investigational product, leading to withdrawal from the study and fatal. Participants could have been counted in more than one category.|From the date of the first dose of investigational product until 30 days after the last dose of investigational product (up to Study Week 164)|Safety Population. Only the participants with at least one event of diarrhea were analyzed.||Events of diarrhea|||Number
717245|NCT00272987|Primary|Number of Participants Who Died Due to Any Cause|Number of participants who died due to any cause during the study or after completion of study were reported.|From the date of the first dose of investigational product until 30 days after the last dose of investigational product (up to Study Week 164)|Safety Population||Participants|||Number
717246|NCT00272987|Primary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations. Refer to the general AE/SAE module for a list of non-serious AEs and SAEs.|From the date of the first dose of investigational product until 30 days after the last dose of investigational product (up to Study Week 164)|Safety Population||Participants|||Number
717247|NCT00272987|Primary|Extent of Exposure to Lapatinib, Trastuzumab and Paclitaxel|Extent of exposure is defined as the duration of the treatment administered during the study. The mean duration of exposure to lapatinib, trastuzumab and paclitaxel is calculated as the number of weeks between the start and end of treatment.|From the date of the first dose of the investigational product up to withdrawal/study completion (up to Study Week 164)|Safety Population: all participants who were randomized and received at least one dose of investigational product.||Weeks||Standard Deviation|Mean
717248|NCT00273052|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) (Glycemic Parameter) by Treatment Group at Maintenance Month 6|Blood draw for glycemia levels. Full beta Quant test performed. Test for Fasting plasma glucose, HbA1c, fasting insulin. Homeostasis model Assessment (HOMA) is a computer-generated model consisting of non-linear empirical equations solved numerically to predict glucose, Insulin and C-peptide concentrations in fasting subjects for insulin sensitivity (%S). Change = Month 6 value minus Baseline value.|Baseline and Month 6|The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).||mg/dL|||Number
717249|NCT00273052|Secondary|Change From Baseline in Homeostasis Model Assessment (Glycemic Parameter) by Treatment Group at Maintenance Month 6|Blood draw for glycemia levels. Full beta Quant test performed. Test for Fasting plasma glucose, HbA1c, fasting insulin. Homeostasis model Assessment (HOMA) is a computer-generated model consisting of non-linear empirical equations solved numerically to predict glucose, Insulin and C-peptide concentrations in fasting subjects for insulin sensitivity (%S). Change = Month 6 value minus Baseline value.|Baseline and Month 6|The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).||Percent Change|||Number
717250|NCT00273052|Secondary|Change From Baseline in c-Peptide (Glycemic Parameter) by Treatment Group at Maintenance Month 6|Blood draw for glycemia levels. Full beta Quant test performed. Test for Fasting plasma glucose, HbA1c, fasting insulin. Homeostasis model Assessment (HOMA) is a computer-generated model consisting of non-linear empirical equations solved numerically to predict glucose, Insulin and C-peptide concentrations in fasting subjects for insulin sensitivity (%S). Change = Month 6 value minus Baseline value.|Baseline and Month 6|The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).||ng/mL|||Number
717430|NCT00276094|Primary|Mean Change From Baseline in Vaginal pH||Baseline (Screening) to Week 12|||pH||Standard Deviation|Mean
717251|NCT00273052|Secondary|Change From Baseline in Hemoglobin A1c (HbA1c) (Glycemic Parameter) by Treatment Group at Maintenance Month 6|Blood draw for glycemia levels. Full beta Quant test performed. Test for Fasting plasma glucose, HbA1c, fasting insulin. Homeostasis model Assessment (HOMA) is a computer-generated model consisting of non-linear empirical equations solved numerically to predict glucose, Insulin and C-peptide concentrations in fasting subjects for insulin sensitivity (%S). Change = Month 6 value minus Baseline value.|Baseline and Month 6|The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).||Percent Change|||Number
717252|NCT00273052|Secondary|Change From Baseline in Fasting Insulin (Glycemic Parameter) by Treatment Group at Maintenance Month 6|Blood draw for glycemia levels. Full beta Quant test performed. Test for Fasting plasma glucose, HbA1c, fasting insulin. Homeostasis model Assessment (HOMA) is a computer-generated model consisting of non-linear empirical equations solved numerically to predict glucose, Insulin and C-peptide concentrations in fasting subjects for insulin sensitivity (%S). Change = Month 6 value minus Baseline value.|Baseline and Month 6|The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).||uIU/mL|||Number
717253|NCT00273052|Secondary|Change From Baseline in Additional Lipid Parameters by Treatment Group With Unit of Measures of g/L at Maintenance Month 6|Blood draw for lipid levels. Full beta Quant test performed. Change = Month 6 value minus Baseline value.|Baseline and Month 6|The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).||g/L|||Number
717254|NCT00273052|Secondary|Change From Baseline in Additional Lipid Parameters by Treatment Group With Unit of Measures of mg/dL at Maintenance Month 6|Blood draw for lipid levels. Full beta Quant test performed with HDL subclasses and IDL. IDL=Intermediate density lipoproteins, LDL=Low-density lipoprotein, VLDL=Very Low density lipoprotein, HDL=High-density lipoprotein. Change = Month 6 value minus Baseline value.|Baseline and Month 6|The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).||mg/dL|||Number
717255|NCT00273052|Secondary|Change From Baseline in Weight by Treatment Group at Maintenance Month|Manual physical examination. Change = Month 6 value minus Baseline value.|Baseline and Month 6|The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).||kg|||Number
717256|NCT00273052|Secondary|Change From Baseline in Heart Rate by Treatment Group at Maintenance Month 6|Manual physical examination. Change = Month 6 value minus Baseline value. (BPM=beats per minute)|Baseline and Month 6|The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).||bpm|||Number
717257|NCT00273052|Secondary|Change From Baseline in Blood Pressure by Treatment Group at Maintenance Month 6|Manual physical examination (cuff blood pressure). Change = Month 6 value minus Baseline value.|Baseline and Month 6|The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).||mm Hg|||Number
717258|NCT00273052|Secondary|Change From Baseline in Log Transformed Lipoprotein-associated Phospholipase A2 (LpPLA2) by Treatment Group at Maintenance Month 6|Blood draw for LpPLA2 activity. Change = Month 6 value minus Baseline value.|Baseline and Month 6|The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).||mcmol/min/L|||Number
717259|NCT00273052|Secondary|Change From Baseline in Log Transformed High Sensitivity C-reactive Protein (Hs-CRP) by Treatment Group at Maintenance Month 6|Blood draw for hs-CRP. Change = Month 6 value minus Baseline value.|Baseline and Month 6|The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).||mg/dL|||Number
717260|NCT00273052|Primary|Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) Levels by Treatment Group at Maintenance Month 6|Blood draw for HDL-C levels. Full beta Quant test performed with HDL subclasses. Change = Month 6 value minus Baseline value.|Baseline and Month 6|The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).||mg/dL|||Number
717261|NCT00273052|Primary|Change From Baseline in Triglycerides Levels by Treatment Group at Maintenance Month 6|Blood draw for triglyceride levels. Full beta quantification test performed which uses ultracentrifugation to partially separate lipoprotein classes and is the basis for the reference methods. Change = Month 6 value minus Baseline value.|Baseline and Month 6|The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).||mg/dL|||Number
717262|NCT00273182|Secondary|Subjects With Left Ventricular (LV) Lead Related Complications During Three Years Post-implant|"A left ventricular lead related complication is defined as an adverse event that requires invasive intervention or leads to loss of significant device function resulting from the presence or performance of the LV lead.
Kaplan-Meier method was used to estimate complication-free rate during the three years of follow-up. Time to the first post-implant LV lead related complication was used for the calculation. Confidence intervals were calculated on a log-log scale."|36 months follow-up|The analysis included data from all subjects enrolled in the InSync Registry study.||participants|||Number
717263|NCT00273182|Secondary|Left Ventricular (LV) Lead Pacing Voltage Threshold|Summary statistics such as mean and 95% CI for the LV lead pacing voltage threshold during the 36 months of follow-up|36 months follow-up|||Volts||95% Confidence Interval|Mean
717264|NCT00273182|Secondary|Left Ventricular (LV) Lead Impedance|Summary statistics such as mean and 95% CI for the LV lead impedance during the 36 months of follow-up.|36 months follow-up|||ohms||95% Confidence Interval|Mean
717265|NCT00273182|Secondary|Left Ventricular (LV) Lead R-wave Amplitude|Summary statistics such as mean and 95% CI for the LV lead R-wave amplitude during the 36 months of follow-up.|36 month follow-up|1999 subjects successfully implanted with a left ventricular lead as part of a Medtronic CRT/CRT-D system.||mV||95% Confidence Interval|Mean
717266|NCT00273182|Primary|Overall Death Rate and Cause Specific Death Rate During Three Years Post Implant.|Survival curves of overall mortality and cause specific mortality (due to progressive heart failure and sudden cardiac death) were created based on Kaplan-Meier estimates. Estimates went out to 36 month time point. Confidence intervals were calculated on a log-log scale. The Kaplan-Meier estimates are reported in the statistical analysis modules|36 month follow-up|The analysis included data from all subjects enrolled in the InSync Registry study and successfully implanted with the InSync or InSync III system.||participants|||Number
717267|NCT00266656|Secondary|Percentage of Participants With Abnormal Audiometry Results Based on Pure Tone Average (PTA)|Percentage of participants with abnormal Audiometry results at baseline, age 10 years, and age 16 years or endpoint. PTA is defined as the average of pure tone hearing thresholds at 500, 1000 and 2000 Hz (Hertz), calculated separately for each ear and for each testing method (air or bone); normal PTA is defined as pure tone hearing threshold less than or equal to 20 dB HL (decibels Hearing Level), and abnormal PTA is defined as pure tone hearing threshold greater than 20 DB HL.|Baseline, Age 10, Age 16, End of Study (10 years)|All participants who had a baseline visit, regardless of whether or not they received Humatrope at any time.||percentage of participants|||Number
717268|NCT00266656|Secondary|Percentage of Participants With Prevalence of Abnormal Audiometry Results|Percentage of participants with abnormal Audiometry results at baseline, age 10 years, and age 16 years or endpoint. Prevalence was calculated as number of participants with abnormal hearing divided by number of participants with measurable pure tone audiometry results at that visit.|Baseline, Age 10, Age 16, End of Study (10 years)|All participants who had a baseline visit, regardless of whether or not they received Humatrope at any time.||percentage of participants|||Number
717269|NCT00266656|Secondary|Percentage of Participants With Abnormal Tympanometry Results|Percentage of participants with abnormal tympanometry [defined as middle ear dysfunction / middle ear effusion / patent pressure equalizer tube or possible tympanic membrane perforation] results at baseline, age 10 years, and age 16 years or endpoint.|Baseline, Age 10, Age 16, End of Study (10 years)|All participants who had a baseline visit, regardless of whether or not they received Humatrope at any time.||percentage of participants|||Number
717270|NCT00266656|Secondary|Percentage of Participants With Occurrence of Pre-specified Clinically Relevant Events|Percentage of participants for whom certain non-serious, pre-specified adverse events (AEs; those that are commonly observed in Turner syndrome or are known to be related to GH treatment: impaired glucose tolerance, diabetes mellitus, hypothyroidism, benign intracranial hypertension, scoliosis, slipped capital femoral epiphysis, solid tumor/leukemia, pancreatitis, ear infections, and high blood pressure) are reported.|Baseline through End of Study (10 years)|All participants who had a baseline visit, regardless of whether or not they received Humatrope at any time.||percentage of participants|||Number
717271|NCT00266656|Secondary|Reports of Serious Adverse Events|"Number of serious adverse events (SAEs) reported. Any adverse event from this study that results in one of the following outcomes, or is significant for any other reason were reported as an SAE: death, initial or prolonged inpatient hospitalization, a life-threatening experience (that is, immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of a study subject, significant for any other reason (includes cancer, other than superficial, and basal cell or squamous cell carcinomas of the skin, that did not meet other serious adverse event criteria).
A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section."|Baseline through End of Study (10 years)|All participants who had a baseline visit, regardless of whether or not they received Humatrope at any time.||events|||Number
717272|NCT00266656|Secondary|Chronological Age at First Visit Participant Attained Bone Age of 14.5 Years|Bone age was measured by standard radiograph, x-ray at baseline and annually for 10 years or until attainment of height velocity less than or equal to 1.0 centimeter per year (cm/year) and bone age greater or equal to 15 years.|Baseline through End of Study (10 years)|All participants who achieved Near Adult Height (NAH). NAH is defined as first height measured when height velocity is less than or equal to 2.0 centimeter per year over the preceding year (in the absence of growth-impairing process such as hypothyroidism or inflammatory bowel disease), or bone age greater than or equal to14.5 years.||years||Standard Error|Mean
717273|NCT00266656|Secondary|Age at Attainment of Tanner 2 Breast Development|The Tanner 2 breast development is the age at first evidence of breast development.|Baseline through End of Study (10 years)|All participants who had a baseline visit and at least one post-baseline visit.||years||Standard Error|Mean
717274|NCT00266656|Secondary|Height SDS at Various Ages|SDS reports the number of standard deviations from the mean for age and sex for an individual measurement (normal range is -2 to +2 SDS). Height SDS is derived by subtracting the population mean from individual's height value and then dividing that difference by the population standard deviation. Greater height SDS values indicate greater height.|Age 10, Age 13, Age 16|All participants who had a baseline visit and at least one post-baseline visit.||Standard deviation score||Standard Deviation|Mean
717482|NCT00276484|Secondary|Percent Change From Baseline to Week 6 in Apolipoprotein B (Apo B)|Percent Change in Apo B = [(week 6 value - baseline value)/baseline value]*100%|Baseline and 6 Weeks|Full Analysis Set||Percent Change||95% Confidence Interval|Least Squares Mean
717275|NCT00266656|Primary|Most Mature Height Standard Deviation Score (SDS)|SDS reports the number of standard deviations from the mean for age and sex for an individual measurement (normal range is -2 to +2 SDS). Height SDS is derived by subtracting the population mean from individual's height value and then dividing that difference by the population standard deviation. Greater height SDS values indicate greater height.|Baseline through End of Study (10 years)|All participants who achieved Near Adult Height (NAH). NAH is defined as first height measured when height velocity is less than or equal to 2.0 centimeter per year over the preceding year (in the absence of growth-impairing process such as hypothyroidism or inflammatory bowel disease), or bone age greater than or equal to14.5 years.||standard deviation score||Standard Deviation|Mean
717276|NCT00266695|Secondary|Number of Participants Receiving Treatment With Panretinal Photocoagulation||Baseline up to Month 24|All enrolled participants.||participants|||Number
717277|NCT00266695|Secondary|Number of Participants Receiving Treatment With Focal/Grid Photocoagulation||Baseline up to Month 24|All enrolled participants.||participants|||Number
717278|NCT00266695|Secondary|Visual Acuity|Best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) was measured at 4 meters (m) using an eye chart with 5 letters per row of decreasing letter size in each successive row. Participants read the chart from the top down until reaching a row where ≥3 letters in the row could not be read correctly. If <20 letters were read correctly at 4 m, the chart was re-read at 1 m. The best-corrected ETDRS VA score was the total number of letters read correctly per eye at 4 m, plus a correction factor of 30 if ≥20 letters were read correctly at 4 m, plus the total number of letters read correctly at 1 m, if assessed. Best-corrected ETDRS VA scores ranged from 0 (no letters read correctly) to 100 (all letters read correctly). A higher score represented better VA.|Month 24|All enrolled participants. Last observation carried forward (LOCF).||letters read correctly||Standard Deviation|Mean
717279|NCT00266695|Secondary|Number of Participants With a Modified Sustained Moderate Vision Loss (mSMVL) Event by Time Interval|An mSMVL event was defined as a ≥15-letter decrease from Study MBDV baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) during any 6-month period, not just the last 6 months of the study. An mSMVL event was the first occurrence of an mSMVL in a participant, and the time at which the mSMVL began was used as the time of the event for the analysis. VA was measured at 4 meters (m) using an eye chart with 5 letters per row. Participants read the chart from the top down until reaching a row where ≥3 letters in the row could not be read correctly. If <20 letters were read correctly at 4 m, the chart was re-read at 1 m. The best-corrected ETDRS VA score was the total number of letters read correctly per eye at 4 m, plus a correction factor of 30 if ≥20 letters were read correctly at 4 m, plus the total number of letters read correctly at 1 m, if assessed.|Baseline up to 6 months, 6 months up to 12 months, 12 months up to 18 months, 18 months up to 24 months, and 24 months up to 30 months|All enrolled participants (pts) at risk during the specified intervals. Pts who did not experience an event during the interval were censored to the last time point in the interval. Number of pts censored: 0 to 6 months = 2 pts, 6 to 12 months = 4 pts, 12 to 18 months = 9 pts, 18 to 24 months = 82 pts, and 24 to 30 months = 90 pts.||participants|||Number
717280|NCT00266695|Secondary|Sustained Moderate Vision Loss (SMVL), Long Term|The number of participants who experienced SMVL, long term, in at least 1 diabetic retinopathy (DR) study eye. Long term SMVL was a ≥15-letter decrease from Study MBCM baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) that was sustained for the last 6 months of Study MBDV. VA was measured at 4 meters (m) using an eye chart with 5 letters per row of decreasing letter size in each successive row. Participants read the chart from the top down until reaching a row where ≥3 letters in the row could not be read correctly. If <20 letters were read correctly at 4 m, the chart was re-read at 1 m. The best-corrected ETDRS VA score was the total number of letters read correctly per eye at 4 m, plus a correction factor of 30 if ≥20 letters were read correctly at 4 m, plus the total number of letters read correctly at 1 m, if assessed. Best-corrected ETDRS VA scores ranged from 0 (no letters read correctly) to 100 (all letters read correctly).|Baseline in Study MBCM, 18 months up to 24 months in Study MBDV (for a total of 75 up to 87 months of SMVL, long term)|Participants who were treated with 32 milligram (mg) ruboxistaurin once daily in Study MBCM and had at least 1 DR study eye, who were also enrolled in Study MBDV.||participants|||Number
717281|NCT00266695|Secondary|Vision Loss|The number of participants whose best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) in at least 1 diabetic retinopathy (DR) study eye decreased by 15-letters or less from the conclusion of Study MBCM to the start of Study MBDV, 6 to 18 months later. Best-corrected ETDRS VA was measured at 4 meters (m) using an eye chart with 5 letters per row of decreasing letter size in each successive row. Participants read the chart from the top down until reaching a row where ≥3 letters in the row could not be read correctly. If <20 letters were read correctly at 4 m, the chart was re-read at 1 m. The best-corrected ETDRS VA score was the total number of letters read correctly per eye at 4 m, plus a correction factor of 30 if ≥20 letters were read correctly at 4 m, plus the total number of letters read correctly at 1 m, if assessed. Best-corrected ETDRS VA scores ranged from 0 (no letters read correctly) to 100 (all letters read correctly).|End of Study MBCM to the beginning of Study MBDV, approximately 6 to 18 months|All enrolled participants.||participants|||Number
717282|NCT00266695|Primary|Sustained Moderate Visual Loss (SMVL)|The number of participants who experienced SMVL in at least 1 diabetic retinopathy (DR) study eye. SMVL was a ≥15-letter decrease from baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) that was sustained for the last 6 months of the study. Best-corrected ETDRS VA was measured at 4 meters (m) using an eye chart with 5 letters per row of decreasing letter size in each successive row. Participants read the chart from the top down until reaching a row where ≥3 letters in the row could not be read correctly. If <20 letters were read correctly at 4 m, the chart was re-read at 1 m. The best-corrected ETDRS VA score was the total number of letters read correctly per eye at 4 m, plus a correction factor of 30 if ≥20 letters were read correctly at 4 m, plus the total number of letters read correctly at 1 m, if assessed. Best-corrected ETDRS VA scores ranged from 0 (no letters read correctly) to 100 (all letters read correctly).|Baseline, 18 months up to 24 months|All enrolled participants.||participants|||Number
717322|NCT00267098|Secondary|Change in Cardiac Index From Randomization to 12 Months|The endpoint will be a subject's change in cardiac index (a measure of how much blood the left ventricle ejects in one minute, normalized over body surface area) from randomization to 12 months. The measure for each subject will be the 12 month - randomization visit value.|Randomization to 12 Months|||liters per minute per squared meter||Standard Deviation|Mean
717283|NCT00266799|Secondary|Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ))|QoL questionnaire was an EORTC QLQ-C30 & SSQ integration. Scores on the SSQ scale ranged from 1 (very much worse) - 7 (very much better). SSQ consisted of 4 items which corresponded to core domains in the 30 Item EORTC QLQ-C30, such as improvement/deterioration in physical functioning, emotional functioning, social functioning, global QoL. Percentages were based on number of participants at each cycle & rounded to the nearest whole number. Early Withdrawal Questionnaires were obtained in 7-14 days of study drug final dose.|From Screening to Day 1 of every Treatment Cycle up to 12 Cycles|ITT: included all randomized participants. There were only a few participants who completed more than 12 cycles due to the longer duration of each cycle.||Percentage of Participants|||Number
717284|NCT00266799|Secondary|Time to Treatment Failure in the PLD and the Capecitabine Treatment Groups|Time to treatment failure was defined as the duration of time from the date of the first administration of the study drug to the date of discontinuation of the study drug for any reason.|From Day 1 (Cycle 1) until End of Treatment|ITT: 7 in PLD group and 3 participants in Capecitabine group were missing response assessments and therefore were not included in the analysis.||Months||95% Confidence Interval|Median
717285|NCT00266799|Secondary|Overall Survival Time in the PLD and Capecitabine Treatment Groups|Survival time was defined as duration time from onset of treatment with the study drug until death.|From Day 1 (Cycle 1) until Death|ITT: 7 in PLD group and 3 participants in Capecitabine group were missing response assessments and therefore were not included in the analysis.||Months||95% Confidence Interval|Median
717286|NCT00266799|Secondary|Number of Participants With an Overall Response (Complete Response [CR] + Partial Response [PR]) Between PLD and Capecitabine Treatment Groups|Overall responses by investigator assessment/RECIST criteria of participant responses; CR=disappearance of target/nontarget lesions + PR=30% decrease in longest diameter sum (noting baseline sum) of target lesions. RECIST used changes in the largest diameter of target/non-target lesions. Target lesions were up to a maximum of 5 per organ & >20 mm by clinical imaging (>=10 mm with spiral CT scan). Non-target lesions were all other lesions. Evaluation of progress was repeated every 3 months (+/-7 days) post first date of lesion measurements, in detection absence until the participant´s death.|From Day 1 (Cycle 1) until First Evidence/Diagnosis of Progressive Disease or Death|Intent-to-treat (ITT) population included all randomized participants.||Participants|||Number
717287|NCT00266799|Primary|Time to Disease Progression (TTP) Using Response Evaluation Criteria in Solid Tumors (RECIST)|TTP was defined as the time from onset of treatment with study drug until first evidence/diagnosis of progressive disease or – in the absence of any diagnosis of progressive disease – until the participant´s death. Diagnosis of progressive disease was done according to RECIST (Version 1.0) and/or investigator assessment based on RECIST. RECIST criteria used changes in the largest diameter of target/non-target lesions. Target (measurable) lesions were up to a maximum of 5 per organ & >20 mm by clinical imaging (>=10 mm with spiral CT scan). Non-target lesions were all other lesions.|From Day 1 (Cycle 1) until First Evidence/Diagnosis of Progressive Disease or Death|Intent-to-treat (ITT): 7 in PLD group & 3 participants in Capecitabine group were missing response assessments. TTP Population: included participants in view of major protocol violations/deviations, i.e. tumor-relevant inclusion/exclusion criteria, treatment compliance, tumor assessments by RECIST with maximum 4 month interval between assessments.||Months||95% Confidence Interval|Median
717288|NCT00266812|Primary|Number of Participants With Progression-free Survival (6 Month)|The occurrence of progression will be compared between the study groups by Kaplan-Meier curves. Responsiveness to temozolomide will be evaluated by brain Magnetic Resonance Imanging (MRI)/Computed Tomography (CT), thorax CT, and Quality of Life (QoL) assessments. Progression-free is defined as <25% increase in tumor size on CT or MRI.|6 months|Intent to treat (ITT) population (31 of the 35 patients enrolled; 4 participants discontinued prior to start of treatment) was analyzed.||Participants|||Number
717289|NCT00266825|Secondary|Preterm Births|Percentage of births occurring at less than 37 weeks of gestation.|births before week 37 of gestation|||percentage of births|||Number
717290|NCT00266825|Secondary|Head Circumference|Measure of circumference of baby's head in centimeters at time of birth.|at time of birth|||centimeters||Standard Deviation|Mean
717291|NCT00266825|Secondary|Cord RBC-phospholipid-DHA|Percentage of total fatty acids by weight in cord RBC|at time of birth|||percentage of cord RBC||Standard Deviation|Mean
717292|NCT00266825|Secondary|Gender of Babies||at time of birth|||percentage of babies|||Number
717293|NCT00266825|Primary|Birth Length|Length of baby at birth|at time of birth|The effect of DHA supplementation on study primary outcomes was determined for black and non-black subjects separately. Researchers did not compare outcomes between black and non-black subjects to determine whether they were statistically different. For measures reporting black and non-black results, there were 184 non-black and 117 black subjects.||centimeters||Standard Deviation|Mean
717294|NCT00266825|Primary|Birth Weight|Weight of baby at birth|at time of birth|The effect of DHA supplementation on study primary outcomes was determined for black and non-black subjects separately. Researchers did not compare outcomes between black and non-black subjects to determine whether they were statistically different. For measures reporting black and non-black results, there were 184 non-black and 117 black subjects.||grams||Standard Deviation|Mean
717295|NCT00266825|Primary|Gestational Age|Gestational age of babies at time of birth in days|at time of birth|The effect of DHA supplementation on study primary outcomes was determined for black and non-black subjects separately. Researchers did not compare outcomes between black and non-black subjects to determine whether they were statistically different. For measures reporting black and non-black results, there were 184 non-black and 117 black subjects.||days||Standard Deviation|Mean
717296|NCT00266825|Secondary|Ponderal Index|Ponderal index calculated with formula Weight (g)/length (cm)^3 * 100. It a measure of leanness of a person and is calculated as a relationship between mass and height. Commonly used in pediatrics.|at time of birth|||units on a scale||Standard Deviation|Mean
717297|NCT00266825|Primary|Percentage of Total Fatty Acids by Weight|Measure of RBC-phospholipid-DHA at Birth|at time of birth|The effect of DHA supplementation on study primary outcomes was determined for black and non-black subjects separately. Researchers did not compare outcomes between black and non-black subjects to determine whether they were statistically different. For measures reporting black and non-black results, there were 184 non-black and 117 black subjects.||percentage of fatty acid||Standard Deviation|Mean
717300|NCT00267007|Secondary|The Number of Patients Who Developed Peripheral Sensory Neuropathy (National Cancer Institute Common Toxicity Criteria (NCI CTC) Score >= 2) at Week 12.|NCI CTC neuropathy: a descriptive terminology used to grade the severity of AEs in cancer subjects on a 0-5 scale. A higher score indicates worse peripheral neuropathy.|baseline to Day 128|MITT(Modified intent to treat)all randomized subjects that received at least one dose and had at least one post-baseline neuropathy assessment.||participants|||Number
717301|NCT00267007|Primary|The Number of Patients Who Developed Peripheral Sensory Neuropathy (National Cancer Institute Common Toxicity Criteria (NCI CTC) Score >= 1) at Week 12.|NCI CTC neuropathy: a descriptive terminology used to grade the severity of AEs in cancer subjects on a 0-5 scale. A higher score indicates worse peripheral neuropathy.|Baseline to Week 12|MITT(Modified intent to treat)all randomized subjects that received at least one dose and had at least one post-baseline neuropathy assessment.||participants|||Number
717302|NCT00267046|Primary|Median Maximum Score for Patient Reported Outcomes in 2 Blinded Cycles|Median maximum score (0 to 10, with 10 being the worst) for participant-reported outcomes in the first 2 blinded cycles for Mouth Pain, Overall Mouth and Throat Soreness, and Rectal Soreness while median maximum score for Swallowing, Drinking and Eating Difficulty (0 to 4, with 4 being the difficult).|Within the first 2 blinded cycles (3-week cycles), up to 6 weeks.|Intention to treat (ITT).||Units on a scale||Full Range|Median
717303|NCT00267046|Primary|Cumulative Incidence Rate of Oral Mucositis|"Cumulative incidence of World Health Organization (WHO) grade 2 or > mucositis (moderate to severe) in participants completing up to 6 blinded cycles. Rate defined as participants who had Grade 2 or > divided by total number of participants who completed up to 6 blinded cycles.
WHO Criteria of Grade 1: possible buccal mucosal scalloping with/without erythema; No ulcers; swallows solid diet. Grade 2: ulcers with or without erythema; swallow solid diet. Grade 3: ulcers with/without (extensive) erythema; swallow liquid, not solid diet. Grade 4: mucositis to extent alimentation not possible."|Within 6 blinded cycles (3-week cycles), up to 18 weeks.|Intention to treat (ITT).||Percentage of Participants||95% Confidence Interval|Mean
717304|NCT00267059|Primary|Number of Patients in Overall Response Categories|Overall Response defined as participant had either complete response (CR) or partial response (PR) assessed after three cycles, at six months and yearly thereafter using the NCI-Working Group Criteria: Complete Response, Complete Response with Nodules, Partial Response, or No Response.|Evaluated after three 28-day cycles of lenalidomide.|Analysis was intention to treat (ITT): Forty four patients received treatment.||Participants|||Number
717305|NCT00267085|Primary|Response: One Log Decrease in BCR-ABL|Molecular response defined as reduction by one log of the circulating peripheral blood for reverse transcription polymerase chain reaction (RT-PCR) transcripts of BCR-ABL (tumor-specific oncogenic fusion protein) after two consecutive measurements. RT-PCR performed at 3 month intervals. Response categorized as either 'No Decrease' or 'Decrease' if one log reduction in BCR-ABL detected.|12 months|All 10 participants on study received treatment and were included in analysis.||Participants|||Number
717306|NCT00267098|Secondary|Incidence of Ventricular Tachyarrhythmias|Among subjects implanted with a Cardiac Resynchronization Therapy with Defibrillation device (CRT-D) and randomized, the endpoint was the time from randomization until the subject experienced a ventricular tachyarrhythmia. For each randomization arm, the number of CRT-D subjects who experienced at least one ventricular tachyarrhythmia post-randomization is reported, as well as the number of CRT-D subjects who did not experience one or more ventricular tachyarrhythmias post-randomization.|Participants were followed for the duration of the study, an average of 37.9 months post-randomization among CRT-D subjects.|"Only randomized subjects in the CRT-D device group were included in the analysis of this endpoint, as the analysis was restricted to post-randomization data recorded by CRT-D devices. Subjects in the No Implant Attempt, Unsuccessful Implants, CRT-D: Not Randomized, and all CRT-P subgroups were excluded."||participants|||Number
717307|NCT00267098|Secondary|CRT-P and CRT-D System Implant Success|The endpoint will be whether each subject who underwent an implant attempt of a Cardiac Resynchronization Therapy device, be it a pacing only device (CRT-P) or a pacing device with defibrillation capability (CRT-D), had a successful procedure (i.e. the generator, left ventricular lead, and right ventricular lead were successfully implanted). Only one implant attempt was allowed.|Initial Implant Procedure|"For this outcome measure, only subjects in the No Implant Attempt subgroup were excluded."||participants|||Number
717308|NCT00267098|Secondary|Clinical Composite Score at 24 Months|The endpoint will be a subject's Clinical Composite Score at 24 months. The Clinical Composite Score is a 3 point score (Worsened, Unchanged, and Improved) based on a number of factors including: whether the subject has died, whether the subject has experienced a heart failure-related hospitalization, whether the subject has discontinued their therapy due to worsening heart failure, whether their New York Heart Association classification has improved or worsened since randomization, and whether they feel moderately or markedly better since randomization.|Randomization to 24 Months|"Only randomized subjects in both device groups were included in the analysis of this endpoint, as the analysis was restricted to post-randomization data. Subjects in the No Implant Attempt, Unsuccessful Implants, CRT-P: Not Randomized, and CRT-D: Not Randomized subgroups were excluded."||participants|||Number
717323|NCT00267098|Secondary|Change in Cardiac Index From Randomization to 6 Months|The endpoint will be a subject's change in cardiac index (a measure of how much blood the left ventricle ejects in one minute, normalized over body surface area) from randomization to 6 months. The measure for each subject will be the 6 month - randomization visit value.|Randomization to 6 Months|||liters per minute per squared meter||Standard Deviation|Mean
717382|NCT00267488|Secondary|Response Duration|The time from initial documented response to the first documented sign of progression or death due to progressive disease. Not calculated due to no Complete response and only 1 partial response.|Week 0 to week 98|||Weeks||95% Confidence Interval|Mean
717309|NCT00267098|Secondary|Clinical Composite Score at 18 Months|The endpoint will be a subject's Clinical Composite Score at 18 months. The Clinical Composite Score is a 3 point score (Worsened, Unchanged, and Improved) based on a number of factors including: whether the subject has died, whether the subject has experienced a heart failure-related hospitalization, whether the subject has discontinued their therapy due to worsening heart failure, whether their New York Heart Association classification has improved or worsened since randomization, and whether they feel moderately or markedly better since randomization.|Randomization to 18 Months|"Only randomized subjects in both device groups were included in the analysis of this endpoint, as the analysis was restricted to post-randomization data. Subjects in the No Implant Attempt, Unsuccessful Implants, CRT-P: Not Randomized, and CRT-D: Not Randomized subgroups were excluded."||participants|||Number
717310|NCT00267098|Secondary|Clinical Composite Score at 12 Months|The endpoint will be a subject's Clinical Composite Score at 12 months. The Clinical Composite Score is a 3 point score (Worsened, Unchanged, and Improved) based on a number of factors including: whether the subject has died, whether the subject has experienced a heart failure-related hospitalization, whether the subject has discontinued their therapy due to worsening heart failure, whether their New York Heart Association classification has improved or worsened since randomization, and whether they feel moderately or markedly better since randomization.|Randomization to 12 Months|"Only randomized subjects in both device groups were included in the analysis of this endpoint, as the analysis was restricted to post-randomization data. Subjects in the No Implant Attempt, Unsuccessful Implants, CRT-P: Not Randomized, and CRT-D: Not Randomized subgroups were excluded."||participants|||Number
717311|NCT00267098|Secondary|Clinical Composite Score at 6 Months|The endpoint will be a subject's Clinical Composite Score at 6 months. The Clinical Composite Score is a 3 point score (Worsened, Unchanged, and Improved) based on a number of factors including: whether the subject has died, whether the subject has experienced a heart failure-related hospitalization, whether the subject has discontinued their therapy due to worsening heart failure, whether their New York Heart Association classification has improved or worsened since randomization, and whether they feel moderately or markedly better since randomization.|Randomization to 6 Months|"Only randomized subjects in both device groups were included in the analysis of this endpoint, as the analysis was restricted to post-randomization data. Subjects in the No Implant Attempt, Unsuccessful Implants, CRT-P: Not Randomized, and CRT-D: Not Randomized subgroups were excluded."||participants|||Number
717312|NCT00267098|Secondary|Change in E Wave/A Wave Ratio (E:A Ratio) From Randomization to 24 Months|The endpoint will be a subject's change in E:A ratio (a measure of diastolic function) from randomization to 24 months. The measure for each subject will be the 24 month - randomization visit difference in E:A ratio. Typical values for the E:A ratio at a single time point are 1.04 in men and 1.03 in women.|Randomization to 24 Months|||ratio||Standard Deviation|Mean
717313|NCT00267098|Secondary|Change in E Wave/A Wave Ratio (E:A Ratio) From Randomization to 18 Months|The endpoint will be a subject's change in E:A ratio (a measure of diastolic function) from randomization to 18 months. The measure for each subject will be the 18 month - randomization visit difference in E:A ratio. Typical values for the E:A ratio at a single time point are 1.04 in men and 1.03 in women.|Randomization to 18 Months|||ratio||Standard Deviation|Mean
717314|NCT00267098|Secondary|Change in E Wave/A Wave Ratio (E:A Ratio) From Randomization to 12 Months|The endpoint will be a subject's change in E:A ratio (a measure of diastolic function) from randomization to 12 months. The measure for each subject will be the 12 month - randomization visit difference in E:A ratio. Typical values for the E:A ratio at a single time point are 1.04 in men and 1.03 in women.|Randomization to 12 Months|||ratio||Standard Deviation|Mean
717315|NCT00267098|Secondary|Change in E Wave/A Wave Ratio (E:A Ratio) From Randomization to 6 Months|The endpoint will be a subject's change in E:A ratio (a measure of diastolic function) from randomization to 6 months. The measure for each subject will be the 6 month - randomization visit difference in E:A ratio. Typical values for the E:A ratio at a single time point are 1.04 in men and 1.03 in women.|Randomization to 6 Months|||ratio||Standard Deviation|Mean
717316|NCT00267098|Secondary|Change in Interventricular Mechanical Delay (IVMD) From Randomization to 24 Months|The endpoint will be a subject's change in interventricular mechanical delay (a measure of dyssynchrony between ventricles, measured in ms) from randomization to the 24 month visit. The measure will be the 24 month - randomization visit difference in IVMD.|Randomization to 24 Months|||ms||Standard Deviation|Mean
717317|NCT00267098|Secondary|Change in Interventricular Mechanical Delay (IVMD) From Randomization to 18 Months|The endpoint will be a subject's change in interventricular mechanical delay (a measure of dyssynchrony between ventricles, measured in ms) from randomization to the 18 month visit. The measure will be the 18 month - randomization visit difference in IVMD.|Randomization to 18 Months|||ms||Standard Deviation|Mean
717318|NCT00267098|Secondary|Change in Interventricular Mechanical Delay (IVMD) From Randomization to 12 Months|The endpoint will be a subject's change in interventricular mechanical delay (a measure of dyssynchrony between ventricles, measured in ms) from randomization to the 12 month visit. The measure will be the 12 month - randomization visit difference in IVMD.|Randomization to 12 Months|||ms||Standard Deviation|Mean
717319|NCT00267098|Secondary|Change in Interventricular Mechanical Delay (IVMD) From Randomization to 6 Months|The endpoint will be a subject's change in interventricular mechanical delay (a measure of dyssynchrony between ventricles, measured in ms) from randomization to the 6 month visit. The measure will be the 6 month - randomization visit difference in IVMD.|Randomization to 6 Months|||ms||Standard Deviation|Mean
717320|NCT00267098|Secondary|Change in Cardiac Index From Randomization to 24 Months|The endpoint will be a subject's change in cardiac index (a measure of how much blood the left ventricle ejects in one minute, normalized over body surface area) from randomization to 24 months. The measure for each subject will be the 24 month - randomization visit value.|Randomization to 24 Months|||liters per minute per squared meter||Standard Deviation|Mean
717321|NCT00267098|Secondary|Change in Cardiac Index From Randomization to 18 Months|The endpoint will be a subject's change in cardiac index (a measure of how much blood the left ventricle ejects in one minute, normalized over body surface area) from randomization to 18 months. The measure for each subject will be the 18 month - randomization visit value.|Randomization to 18 Months|||liters per minute per squared meter||Standard Deviation|Mean
717483|NCT00276484|Secondary|Percent Change From Baseline to Week 6 in Triglycerides (TG)|Percent Change in TG = [(week 6 value - baseline value)/baseline value]*100%|Baseline and 6 Weeks|Full Analysis Set||Percent Change||95% Confidence Interval|Least Squares Mean
717325|NCT00267098|Secondary|Change in Mitral Regurgitation From Randomization to 18 Months|The endpoint will be a subject's change in mitral regurgitation (a measure of how much blood flows backwards into the heart due to the mitral valve not closing properly). The measure for each subject will be the 18 month - randomization visit difference in mitral regurgitation. Negative values reflect reductions in mitral regurgitation over time.|Randomization to 18 Months|||percentage of left atrial area||Standard Deviation|Mean
717326|NCT00267098|Secondary|Change in Mitral Regurgitation From Randomization to 12 Months|The endpoint will be a subject's change in mitral regurgitation (a measure of how much blood flows backwards into the heart due to the mitral valve not closing properly). The measure for each subject will be the 12 month - randomization visit difference in mitral regurgitation. Negative values reflect reductions in mitral regurgitation over time.|Randomization to 12 Months|||percentage of left atrial area||Standard Deviation|Mean
717327|NCT00267098|Secondary|Change in Mitral Regurgitation From Randomization to 6 Months|The endpoint will be a subject's change in mitral regurgitation (a measure of how much blood flows backwards into the heart due to the mitral valve not closing properly). The measure for each subject will be the 6 month - randomization visit difference in mitral regurgitation. Negative values reflect reductions in mitral regurgitation over time.|Randomization to 6 Months|||percentage of left atrial area||Standard Deviation|Mean
717328|NCT00267098|Secondary|Change in Left Ventricular End Systolic Dimension (LVESD) From Randomization to 24 Months|The endpoint will be a subject's change in LVESD (a measure of the dimension of the left ventricle at the end of systole). For each subject the measure was the 24 month - randomization visit difference in LVESD value. Negative values correspond to reductions in LVESD.|Randomization to 24 Months|||cm||Standard Deviation|Mean
717329|NCT00267098|Secondary|Change in Left Ventricular End Systolic Dimension (LVESD) From Randomization to 18 Months|The endpoint will be a subject's change in LVESD (a measure of the dimension of the left ventricle at the end of systole). For each subject the measure was the 18 month - randomization visit difference in LVESD value. Negative values correspond to reductions in LVESD.|Randomization to 18 Months|||cm||Standard Deviation|Mean
717330|NCT00267098|Secondary|Change in Left Ventricular End Systolic Dimension (LVESD) From Randomization to 12 Months|The endpoint will be a subject's change in LVESD (a measure of the dimension of the left ventricle at the end of systole). For each subject the measure was the 12 month - randomization visit difference in LVESD value. Negative values correspond to reductions in LVESD.|Randomization to 12 Months|||cm||Standard Deviation|Mean
717331|NCT00267098|Secondary|Change in Left Ventricular End Systolic Dimension (LVESD) From Randomization to 6 Months|The endpoint will be a subject's change in LVESD (a measure of the dimension of the left ventricle at the end of systole). For each subject the measure was the 6 month - randomization visit difference in LVESD value. Negative values correspond to reductions in LVESD.|Randomization to 6 Months|||cm||Standard Deviation|Mean
717332|NCT00267098|Secondary|Change in Left Ventricular End Diastolic Dimension (LVEDD) From Randomization to 24 Months|The endpoint will be a subject's change in LVEDD (a measure of the dimension of the left ventricle at the end of diastole). For each subject the measure was the 24 month - randomization visit difference in LVEDD value. Negative values correspond to reductions in LVEDD.|Randomization to 24 Months|||cm||Standard Deviation|Mean
717333|NCT00267098|Secondary|Change in Left Ventricular End Diastolic Dimension (LVEDD) From Randomization to 18 Months|The endpoint will be a subject's change in LVEDD (a measure of the dimension of the left ventricle at the end of diastole). For each subject the measure was the 18 month - randomization visit difference in LVEDD value. Negative values correspond to reductions in LVEDD.|Randomization to 18 Months|||cm||Standard Deviation|Mean
717334|NCT00267098|Secondary|Change in Left Ventricular End Diastolic Dimension (LVEDD) From Randomization to 12 Months|The endpoint will be a subject's change in LVEDD (a measure of the dimension of the left ventricle at the end of diastole). For each subject the measure was the 12 month - randomization visit difference in LVEDD value. Negative values correspond to reductions in LVEDD.|Randomization to 12 Months|||cm||Standard Deviation|Mean
717335|NCT00267098|Secondary|Change in Left Ventricular End Diastolic Dimension (LVEDD) From Randomization to 6 Months|The endpoint will be a subject's change in LVEDD (a measure of the dimension of the left ventricle at the end of diastole). For each subject the measure was the 6 month - randomization visit difference in LVEDD value. Negative values correspond to reductions in LVEDD.|Randomization to 6 Months|||cm||Standard Deviation|Mean
717336|NCT00267098|Secondary|Change in Left Ventricular Mass (LV Mass) From Randomization to 24 Months|The endpoint will be a subject's change in Left Ventricular Mass ( a measure of the size of the left ventricle) from randomization to 24 months. For each subject the measurement was calculated as 24 month - randomization visit difference in LV mass measurement. Negative values correspond to a reduction in LV mass over time.|Randomization to 24 Months|||grams||Standard Deviation|Mean
717337|NCT00267098|Secondary|Change in Left Ventricular Mass (LV Mass) From Randomization to 18 Months|The endpoint will be a subject's change in Left Ventricular Mass ( a measure of the size of the left ventricle) from randomization to 18 months. For each subject the measurement was calculated as 18 month - randomization visit difference in LV mass measurement. Negative values correspond to a reduction in LV mass over time.|Randomization to 18 Months|||grams||Standard Deviation|Mean
717338|NCT00267098|Secondary|Change in Left Ventricular Mass (LV Mass) From Randomization to 12 Months|The endpoint will be a subject's change in Left Ventricular Mass ( a measure of the size of the left ventricle) from randomization to 12 months. For each subject the measurement was calculated as 12 month - randomization visit difference in LV mass measurement. Negative values correspond to a reduction in LV mass over time.|Randomization to 12 Months|||grams||Standard Deviation|Mean
717339|NCT00267098|Secondary|Change in Left Ventricular Mass (LV Mass) From Randomization to 6 Months|The endpoint will be a subject's change in Left Ventricular Mass ( a measure of the size of the left ventricle) from randomization to 6 months. For each subject the measurement was calculated as 6 month - randomization visit difference in LV mass measurement. Negative values correspond to a reduction in LV mass over time.|Randomization to 6 Months|||grams||Standard Deviation|Mean
717383|NCT00267488|Secondary|Overall Survival|Kaplan-Meier Estimate. Overall survival is defined as time from start of treatment until death due to any cause. Subjects who are alive at the time of analysis will be censored at the time of last contact.|Week 0 to Week 98|Intent To Treat (ITT) Population - All subjects who received at least one dose of study medication.||Weeks||95% Confidence Interval|Mean
717340|NCT00267098|Secondary|Change in Left Ventricular End Diastolic Volume Index (LVEDVI) From Randomization to 24 Months|The endpoint will be a subject's change in Left Ventricular End Diastolic Volume Index (a measure of the volume of blood in the left ventricle at the end of diastole, normalized over body surface area). In other words, a measure of the size of the left ventricle. For each subject the measure is the 24 month - randomization visit difference in LVEDVI. Negative values correspond to reductions in LVEDVI over time.|Randomization to 24 Months|||ml/square meter of body surface area||Standard Deviation|Mean
717341|NCT00267098|Secondary|Change in Left Ventricular End Diastolic Volume Index (LVEDVI) From Randomization to 18 Months|The endpoint will be a subject's change in Left Ventricular End Diastolic Volume Index (a measure of the volume of blood in the left ventricle at the end of diastole, normalized over body surface area). In other words, a measure of the size of the left ventricle. For each subject the measure is the 18 month - randomization visit difference in LVEDVI. Negative values correspond to reductions in LVEDVI over time.|Randomization to 18 Months|||ml/square meter of body surface area||Standard Deviation|Mean
717342|NCT00267098|Secondary|Change in Left Ventricular End Diastolic Volume Index (LVEDVI) From Randomization to 12 Months|The endpoint will be a subject's change in Left Ventricular End Diastolic Volume Index (a measure of the volume of blood in the left ventricle at the end of diastole, normalized over body surface area). In other words, a measure of the size of the left ventricle. For each subject the measure is the 12 month - randomization visit difference in LVEDVI. Negative values correspond to reductions in LVEDVI over time.|Randomization to 12 Months|||ml/square meter of body surface area||Standard Deviation|Mean
717343|NCT00267098|Secondary|Change in Left Ventricular End Diastolic Volume Index (LVEDVI) From Randomization to 6 Months|The endpoint will be a subject's change in Left Ventricular End Diastolic Volume Index (a measure of the volume of blood in the left ventricle at the end of diastole, normalized over body surface area). In other words, a measure of the size of the left ventricle. For each subject the measure is the 6 month - randomization visit difference in LVEDVI. Negative values correspond to reductions in LVEDVI over time.|Randomization to 6 Months|||ml/square meter of body surface area||Standard Deviation|Mean
717344|NCT00267098|Secondary|Change in Left Ventricular End Systolic Volume Index (LVESVI) From Randomization to 24 Months|The endpoint will be a subject's change in Left Ventricular End Systolic Volume Index (a measure of the volume of blood in the left ventricle at the end of systole, normalized over body surface area). In other words, a measure of the size of the left ventricle. For each subject the measure is the 24 month - randomization visit difference in LVESVI. Negative values correspond to reductions in LVESVI over time.|Randomization to 24 Months|||ml/square meter of body surface area||Standard Deviation|Mean
717345|NCT00267098|Secondary|Change in Left Ventricular End Systolic Volume Index (LVESVI) From Randomization to 18 Months|The endpoint will be a subject's change in Left Ventricular End Systolic Volume Index (a measure of the volume of blood in the left ventricle at the end of systole, normalized over body surface area). In other words, a measure of the size of the left ventricle. For each subject the measure is the 18 month - randomization visit difference in LVESVI. Negative values correspond to reductions in LVESVI over time.|Randomization to 18 Months|||ml/square meter of body surface area||Standard Deviation|Mean
717346|NCT00267098|Secondary|Change in Left Ventricular End Systolic Volume Index (LVESVI) From Randomization to 12 Months|The endpoint will be a subject's change in Left Ventricular End Systolic Volume Index (a measure of the volume of blood in the left ventricle at the end of systole, normalized over body surface area). In other words, a measure of the size of the left ventricle. For each subject the measure is the 12 month - randomization visit difference in LVESVI. Negative values correspond to reductions in LVESVI over time.|Randomization to 12 Months|||ml/square meter of body surface area||Standard Deviation|Mean
717347|NCT00267098|Secondary|Change in Left Ventricular End Systolic Volume Index (LVESVI) From Randomization to 6 Months|The endpoint will be a subject's change in Left Ventricular End Systolic Volume Index (a measure of the volume of blood in the left ventricle at the end of systole, normalized over body surface area). In other words, a measure of the size of the left ventricle. For each subject the measure is the 6 month - randomization visit difference in LVESVI. Negative values correspond to reductions in LVESVI over time.|Randomization to 6 Months|||ml/square meter of body surface area||Standard Deviation|Mean
717348|NCT00267098|Secondary|Change in Left Ventricular Ejection Fraction (LVEF) From Randomization to 24 Months|The endpoint will be a subject's change in LV Ejection Fraction (a measure of the percentage of blood ejected from the left ventricle of the heart with each contraction). A normal range is 55% to 70%. For each subject the measure will be the 24 month - randomization visit difference in LVEF value.|Randomization to 24 Months|||percentage||Standard Deviation|Mean
717349|NCT00267098|Secondary|Change in Left Ventricular Ejection Fraction (LVEF) From Randomization to 18 Months|The endpoint will be a subject's change in LV Ejection Fraction (a measure of the percentage of blood ejected from the left ventricle of the heart with each contraction). A normal range is 55% to 70%. For each subject the measure will be the 18 month - randomization visit difference in LVEF value.|Randomization to 18 Months|||percentage||Standard Deviation|Mean
717350|NCT00267098|Secondary|Change in Left Ventricular Ejection Fraction (LVEF) From Randomization to 12 Months|The endpoint will be a subject's change in LV Ejection Fraction (a measure of the percentage of blood ejected from the left ventricle of the heart with each contraction). A normal range is 55% to 70%. For each subject the measure will be the 12 month - randomization visit difference in LVEF value.|Randomization to 12 Months|||percentage||Standard Deviation|Mean
717351|NCT00267098|Secondary|Change in Left Ventricular Ejection Fraction (LVEF) From Randomization to 6 Months|The endpoint will be a subject's change in LV Ejection Fraction (a measure of the percentage of blood ejected from the left ventricle of the heart with each contraction). A normal range is 55% to 70%. For each subject the measure will be the 6 month - randomization visit difference in LVEF value.|Randomization to 6 Months|||percentage||Standard Deviation|Mean
717384|NCT00267488|Secondary|Time to Progression|Kaplan-Meier Estimate. Time to progression is defined as time from start of treatment until the first documented sign of disease progression or death due to progressive disease. Subjects who have not progressed or died at the time of analysis will be censored at the time of initiation of alternative anti-cancer therapy or time of last contact. Percentiles represent a set of points on a scale arrived at by dividing a group into parts in order of magnitude.|Week 0 to Week 19 when endpoints were met|Intent To Treat (ITT) Population - All subjects who received at least one dose of study medication.||Weeks||95% Confidence Interval|Mean
717352|NCT00267098|Secondary|Change in Quality of Life at 24 Months|"The endpoint will be a subject's change in Quality of Life score from randomization to 24 months. The Quality of Life score at a time point is calculated using the Minnesota Living with Heart Failure Questionnaire, which consists of 21 questions each on a 6 point scale from 0 to 5. The 21 scores are added up and the final score, ranging from 0 (best) to 105 (worst) is the subject's quality of life score. For each subject the measure will be the randomization visit - 24 month difference in QOL score, with positive values denoting a reduction in score and improvement in Quality of Life.
Subjects with missing QOL scores at one or both time points were excluded from analysis, and so the number of subjects analyzed for this outcome was a subset of the number of randomized subjects."|Randomization to 24 Months|||units on a scale||Standard Deviation|Mean
717353|NCT00267098|Secondary|Change in Quality of Life at 18 Months|"The endpoint will be a subject's change in Quality of Life score from randomization to 18 months. The Quality of Life score at a time point is calculated using the Minnesota Living with Heart Failure Questionnaire, which consists of 21 questions each on a 6 point scale from 0 to 5. The 21 scores are added up and the final score, ranging from 0 (best) to 105 (worst) is the subject's quality of life score. For each subject the measure will be the randomization visit - 18 month difference in QOL score, with positive values denoting a reduction in score and improvement in Quality of Life.
Subjects with missing QOL scores at one or both time points were excluded from analysis, and so the number of subjects analyzed for this outcome was a subset of the number of randomized subjects."|Randomization to 18 Months|||units on a scale||Standard Deviation|Mean
717354|NCT00267098|Secondary|Change in Quality of Life at 12 Months|"The endpoint will be a subject's change in Quality of Life score from randomization to 12 months. The Quality of Life score at a time point is calculated using the Minnesota Living with Heart Failure Questionnaire, which consists of 21 questions each on a 6 point scale from 0 to 5. The 21 scores are added up and the final score, ranging from 0 (best) to 105 (worst) is the subject's quality of life score. For each subject the measure will be the randomization visit - 12 month difference in QOL score, with positive values denoting a reduction in score and improvement in Quality of Life.
Subjects with missing QOL scores at one or both time points were excluded from analysis, and so the number of subjects analyzed for this outcome was a subset of the number of randomized subjects."|Randomization to 12 months|||units on a scale||Standard Deviation|Mean
717355|NCT00267098|Secondary|Change in Quality of Life at 6 Months|"The endpoint will be a subject's change in Quality of Life score from randomization to 6 months. The Quality of Life score at a time point is calculated using the Minnesota Living with Heart Failure Questionnaire, which consists of 21 questions each on a 6 point scale from 0 to 5. The 21 scores are added up and the final score, ranging from 0 (best) to 105 (worst) is the subject's quality of life score. For each subject the measure will be the randomization visit - 6 month difference in QOL score, with positive values denoting a reduction in score and improvement in Quality of Life.
Subjects with missing QOL scores at one or both time points were excluded from analysis, and so the number of subjects analyzed for this outcome was a subset of the number of randomized subjects."|Randomization to 6 Months|||units on a scale||Standard Deviation|Mean
717356|NCT00267098|Secondary|Cardiovascular-related Healthcare Utilizations|Cardiovascular-related healthcare utilizations (HCUs), such as hospitalizations, Emergency Department visits, urgent care visits, and clinic visits that subjects experienced after being randomized were summarized for each randomization arm|Participants were followed for the duration of the study, an average of 39.8 months post-randomization.|||participants|||Number
717357|NCT00267098|Secondary|Frequency of Adverse Events Post-randomization|Adverse events that subjects experienced after they were randomized were compared between arms with regard to several categories such as heart failure (HF)-relatedness, relatedness to the implant procedure, and relatedness to the implanted system, including individual components such as the left ventricular (LV) lead and the CRT-P or CRT-D generator.|Participants were followed for the duration of the study, an average of 39.8 months post-randomization.|||participants|||Number
717358|NCT00267098|Secondary|Change in Cardiovascular Medications|The endpoints are what classes of drugs (e.g. Beta blockers, Diuretics, Nitrates, etc.) each subject was on at the time of scheduled visits (e.g Randomization, 6 months, 12 months, etc.)|Participants were followed for the duration of the study, an average of 39.8 months post-randomization.|"Because indications for defibrillation devices like CRT-Ds are defined by characteristics that relate to medication guidelines, medication results are presented separately for each device group. Medications were assessed only for subjects who completed visits (denoted as Subjects with Medications Assessed)."||participants|||Number
717359|NCT00267098|Secondary|Change in Heart Failure Stage|The endpoint is a subject's change in Heart Failure Stage (a measure of the degree of heart failure a subject has on a 4 stage scale (A, B, C, D), with Class A being the healthiest score and Class D being the sickest score) from randomization to each of four time points: 6 months, 12 months, 18 months, and 24 months.|Randomization to 24 Months|"For each time point(e.g. 6 months), only subjects with HF Stage assessed at randomization and that time point were included in the analysis. Those who could not be analyzed at a time point(for reasons such as death, exit,missed visit,or HF Stage not assessed) are listed under the Comparative data not available category for that time point."||participants|||Number
717360|NCT00267098|Secondary|Change in New York Heart Association Classification|The endpoint is a subject's change in New York Heart Association Classification (a measure of the degree of heart failure a subject has on a 4 class scale, with NYHA I being the healthiest score and NYHA IV being the sickest score) from randomization to each of four time points: 6 months, 12 months, 18 months, and 24 months post-randomization. The change categories listed will be relative to randomization.|Randomization to 24 Months|"For each time point(e.g. 6 months), only subjects with NYHA assessed at both randomization and that time point were included in the analysis. Those who could not be analyzed at a time point(for reasons such as death, exit,missed visit,or NYHA not assessed at visit) are listed under the Comparative data not available category for that time point."||participants|||Number
717385|NCT00267488|Primary|Best Overall Response|Tumor response based on GOG (Gynecological Oncology Group) modified RECIST (Response Evaluation Criteria In Solid Tumors) criteria. A 4-point scale used specifying tumor response. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions; (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; (PD): At least a 20% increase in the sum of the LD of target lesions|Week 0 to Week 98 when endpoints were met|Intent To Treat (ITT) Population - All subjects who received at least one dose of study medication.||Participants|||Number
717361|NCT00267098|Secondary|Days Hospitalized for Heart Failure|For each subject the endpoint was the days hospitalized for heart failure per patient year, calculated as the total number of days the subject was hospitalized for heart failure divided by the subject's total follow-up time. Only post-randomization data were used.|Participants were followed for the duration of the study, an average of 39.8 months post-randomization.|"Only randomized subjects in both device groups were included in the analysis of this endpoint, as the analysis was restricted to post-randomization data. Subjects in the No Implant Attempt, Unsuccessful Implants, CRT-P: Not Randomized, and CRT-D: Not Randomized subgroups were excluded."||Days hospitalized per patient year||Standard Deviation|Mean
717362|NCT00267098|Secondary|First Heart Failure Hospitalization|The endpoint is the time from randomization to a subject's first heart failure (HF)-related hospitalization. For each randomization arm, the number of subjects who met the endpoint, experiencing at least one heart failure-related hospitalization post-randomization, are reported, as well as the number of randomized subjects who did not experience any HF hospitalizations post-randomization.|Participants were followed for the duration of the study, an average of 39.8 months post-randomization.|"Only randomized subjects in both device groups were included in the analysis of this endpoint, as the analysis was restricted to post-randomization data. Subjects in the No Implant Attempt, Unsuccessful Implants, CRT-P: Not Randomized, and CRT-D: Not Randomized subgroups were excluded."||participants|||Number
717363|NCT00267098|Secondary|All-Cause Mortality or Significant Increase in Left Ventricular End Systolic Volume Index|"The endpoint will be the time from randomization to either death or a visit (6, 12, 18, 24 month or interim visit) in which the subject undergoes an echocardiogram and the measured left ventricular end systolic volume index (a measure of the size of the subject's left ventricle normalized over their body surface area) is at least 15% greater than the corresponding measured value at randomization.
Only LVESVI endpoints/deaths and follow-up data occurring before a subject missed an LVESVI measurement (due to missed visit, echo not performed, etc.) were used in the analysis and included in the table below. The counts reflect the number of subjects meeting each endpoint, and are not mutually exclusive."|Participants were followed for the duration of the study, an average of 39.8 months post-randomization.|"Only randomized subjects in both device groups were included in the analysis of this endpoint, as the analysis was restricted to post-randomization data. Subjects in the No Implant Attempt, Unsuccessful Implants, CRT-P: Not Randomized, and CRT-D: Not Randomized subgroups were excluded."||participants|||Number
717364|NCT00267098|Secondary|All-Cause Mortality or Heart Failure-related Hospitalization|The endpoint will be a subject's time from randomization to either their first heart failure-related hospitalization, or death.|Participants were followed for the duration of the study, an average of 39.8 months post-randomization.|"Only randomized subjects in both device groups were included in the analysis of this endpoint, as the analysis was restricted to post-randomization data. Subjects in the No Implant Attempt, Unsuccessful Implants, CRT-P: Not Randomized, and CRT-D: Not Randomized subgroups were excluded."||participants|||Number
717365|NCT00267098|Secondary|All-Cause Mortality|"The endpoint is the time to death from any cause. The rate of mortality, as measure by the hazard rate, in each randomization arm will be compared.
This outcome includes all post-randomization deaths, whereas the reporting of the primary outcome excluded primary endpoints (including deaths) that occurred after the subject had missed a study-required echocardiogram (used to determine if the LVESVI primary endpoint was met)."|Participants were followed for the duration of the study, an average of 39.8 months post-randomization.|"Only randomized subjects in both device groups were included in the analysis of this endpoint, as the analysis was restricted to post-randomization data. Subjects in the No Implant Attempt, Unsuccessful Implants, CRT-P: Not Randomized, and CRT-D: Not Randomized subgroups were excluded."||participants|||Number
717366|NCT00267098|Primary|Mortality, Heart Failure-related Urgent Care Visits, or Significant Increase in Left Ventricular End Systolic Volume Index (LVESVI)|Events include all-cause mortality, heart failure(HF)-related urgent care (a healthcare utilization visit involving intravenous(IV) therapy for heart failure) or significant increase(at least 15%) in LVESVI (a measure of the volume of a patient's left ventricle) from randomization to a later time point. Time from randomization until the subject experienced one of these events served as the outcome measure. LVESVI endpoints occurred primarily at those visits in which LVESVI measurements were required (6, 12, 18, 24 months). Because endpoints such as death or HF urgent care could occur at any time during follow-up, the subject's outcome measure could range from less than 1 month to 105 months (maximum follow-up duration). Primary endpoints and follow-up data occurring after a subject missed a required LVESVI measurement were excluded from the analysis and the table below. The counts reflect the number of subjects meeting each endpoint, and are not necessarily mutually exclusive.|Participants were followed for the duration of the study, an average of 39.8 months post-randomization.|"Only randomized subjects in both device groups were included in the analysis of this endpoint, as the analysis was restricted to post-randomization data. Subjects in the No Implant Attempt, Unsuccessful Implants, CRT-P: Not Randomized, and CRT-D: Not Randomized subgroups were excluded."||participants|||Number
717367|NCT00267111|Secondary|Visual Analogue Scale|Parents and nurses were asked to assess the infant’s pain response during the procedure using Visual analogue scale (VAS) on an unmarked horizontal 10 cm continuous line where 0=“no pain” on the left side and 10=“worst possible pain” on the right side. Parents and nurses were trained to use the VAS prior to the IM injection.|During the entire procedure|Intention to treat analysis||Cms||Standard Deviation|Mean
717368|NCT00267111|Primary|Pain Scores Assessed by Neonatal Facial Action|The presence or absence of 3 facial actions (brow bulge, eyes squeeze and deepening of the nasolabial furrow) were scored in 2 second intervals for the first 20 seconds (or less if the phase lasted < 20 seconds) of each procedure phase from the videotapes by a trained research assistant. The data were then collapsed for each facial action into the percentage of time the infant expressed the action. An overall pain score was computed by summing the percentage scores for the three facial actions and then dividing by three. The score ranged from 0% to 100% with higher values suggesting more pain.|For the purpose of analysis IM injection procedure was divided into 4 phases: baseline , cleansing, injection and recovery phases.. For each phase facial actions were scored for the first 20 seconds or less if the phase lasted < 20 seconds.|Intention to treat analysis||Percentage of time||Standard Deviation|Mean
717369|NCT00267150|Secondary|Gastrointestinal Symptoms Under MMF-based Immunosuppressive Therapy|Assessed by GI complications at baseline.|week 0|Baseline population||Participants|||Number
717370|NCT00267150|Primary|Changes in Gastrointestinal Symptom Severity and/or Health-related Quality of Life After Conversion From MMF to Enteric Coated Mycophenolate Sodium|The Gastrointestinal symptom rating scale (GSRS) is a 15-item instrument designed to assess the symptoms associated with common gastrointestinal disorders. The GSRS has 5 subscales (reflux, diarrhea, constipation,abdominal pain, and indigestion) producing a mean subscale score ranging from 1 (no discomfort) to 7 (very severe discomfort). The GSRS total score was computed by the mean of the subscale scores. The primary analysis examined changes from Visit 1 (baseline) to Visit 2 (6-8 weeks) by computing the difference of GSRS total score.|weeks 6-8|||Change in Score of GSRS||Standard Deviation|Mean
717371|NCT00267189|Secondary|Number of Patients With Discontinuation of Study Medication||6 months|Intention to treat (ITT) population includes all patients who were randomized to one of the treatment groups and received at least one dose of study medication.||Patients|||Number
717372|NCT00267189|Secondary|Percentage of Patients With Efficacy Failure (Biopsy Proven Acute Rejection [BPAR], Graft Loss or Death)|The composite efficacy failure endpoint encompasses at least one of: biopsy proven acute rejection, graft loss, or death for the patient. BPAR was defined as a clinically suspected acute rejection confirmed by biopsy. Acute rejection episodes were recorded as Liver Allograft Rejection. The allograft was presumed to be lost if a patient had a liver retransplant or died.|6 months|Intention to treat (ITT) population includes all patients who were randomized to one of the treatment groups and received at least one dose of study medication.||Percentage of patients|||Number
717373|NCT00267189|Primary|Mean Change From Baseline in Cockcroft-Gault Calculated Creatinine Clearance (CrCl)|"The primary variable was renal function assessed by calculated creatinine clearance using the Cockcroft-Gault formula, and was assessed at all visits.
CrCl[mL/min] = (140 – A) * W / (72 * C) * R. Where A is age at sample date [years], W is body weight at specific visit [kg], C is the serum concentration of creatinine [mg/dL], R = 1 if the patient is male and = 0.85 if female."|From baseline to 6 months|Intention to treat (ITT) population includes all patients who were randomized to one of the treatment groups and received at least one dose of study medication. Patients with baseline and 6 month creatinine clearance were included in analysis. Missing values at 6 months were imputed using the last observation carried forward (LOCF) approach.||mL/min||Standard Deviation|Mean
717374|NCT00267202|Secondary|Number of Participants Requiring 0 to >=5 Doses of Rescue Medications for Systemic Allergic Reactions (SARs) to Specific Immunotherapy (SIT)|Epinephrine for injection, antihistamines, corticosteroids for injection, inhaled beta-agonists, and oral corticosteroids, as well as other drugs used for managing acute allergic reactions to SIT, were available during all study visits. One dose of rescue medication for SAR reactions was equivalent to 1 entry of the CRF page 'concomitant medications/significant non-drug therapies associated with immunotherapy' in response to the question 'Was this medication given in response to a SAR?'|Up to 26 Weeks|Efficacy population: Consisted of all randomized participants who completed the omalizumab or placebo treatment period, received at least one dose of immunotherapy and received rescue therapy.||participants|||Number
717375|NCT00267202|Secondary|Number of Participants Requiring 8 to 20 Visits to Complete Cluster Specific Immunotherapy (SIT) Dosing Regimen|During period 3, a cluster dosing protocol was utilized to initiate the allergen immunotherapy (IT). Participants received escalating doses of IT according to a cluster dosing titration regimen. Visits 5 through 13 were cluster visits for this study. The number of visits needed for completion of the cluster SIT dosing regimen was defined as the number of planned visits plus the number of unplanned visits needed to reach maintenance IT dose.|Up to 26 Weeks|Efficacy population: Consisted of all randomized patients who completed the omalizumab or placebo treatment period and received at least one dose of immunotherapy.||participants|||Number
717376|NCT00267202|Secondary|Number of Participants Who Achieved Target Maintenance Specific Immunotherapy (SIT) Dose|Achievement of target maintenance IT dose is defined as answering 'Yes' to the question, 'Was the target maintenance SIT dose achieved?' on Visit 13, Week 16.|16 Weeks|Efficacy population: Consisted of all randomized patients who completed the omalizumab or placebo treatment period and received at least one dose of immunotherapy.||participants|||Number
717377|NCT00267202|Secondary|Severity of First Systemic Allergic Reaction (SAR)|Systemic reactions associated with immunotherapy (IT), defined as occurring within 1 hour following injection of SIT, were graded on a four-point scale: Grade 1: Skin symptoms (generalized urticaria, itching, or erythema), Grade 2: Gastrointestinal symptoms (stomach pain, nausea, or vomiting), Grade 3: Respiratory symptoms (clinically significant nasal symptoms and/or dyspnea, wheezing, persistent cough, etc.), Grade 4: Cardiovascular symptoms (cyanosis, hypotension, collapse, arrhythmias, or angina pectoris).|26 Weeks|Efficacy population: Consisted of all randomized patients who completed the omalizumab or placebo treatment period and received at least one dose of immunotherapy.||participants|||Number
717378|NCT00267202|Primary|Number of Participants With Systemic Allergic Reactions (SAR) to Specific Immunotherapy (SIT)|The number of participants with Systemic Allergic Reactions (SAR) to Specific Immunotherapy (SIT). A SAR was captured and recorded as an outcome, not as adverse events (AEs) or SAEs. The primary analysis time point was the end of Period 4 (maintenance immunotherapy). Participants were observed for 1 hour after each immunotherapy (IT) injection visit. Allergic reactions were graded on a 4-point scale from Grade 1 to Grade 4. Grade 1: Skin symptoms, Grade 2: Gastrointestinal symptoms, Grade 3: Respiratory symptoms and Grade 4: Cardiovascular symptoms.|26 Weeks|Efficacy Population: Consisted of all randomized patients who completed the omalizumab or placebo treatment period and received at least one dose of immunotherapy.||participants|||Number
717379|NCT00267293|Primary|Child Temperature (Degrees C)Over 6 Hours|Temperature was measured hourly using a temporal thermometer to monitor the child's temperature in degrees C. Temperature of 38 degrees C or higher was considered febrile.|6 hours|Analysis was ITT per sample size calculation at 80% power.||degrees Celcius||Standard Deviation|Mean
717380|NCT00267488|Secondary|Safety and Tolerability as Summarized Through Adverse Event Reporting|AE = Adverse Event reported at a frequency of greater than or equal to 16%. SAE = Serious Adverse Events where all were reported at 0% frequency.|Week 0 to week 98|Intent To Treat (ITT) Population - All subjects who received at least one dose of study medication.||Number of Events|||Number
717381|NCT00267488|Secondary|Time to Response|The time from start of treatment until the first documented response. Not calculated due to no Complete response and only 1 partial response.|Week 0 to week 98|||Hours||95% Confidence Interval|Mean
717386|NCT00267631|Primary|Diagnosis of Infectious Disease|The Children visiting the ED having an infectious disease|30 minutes|||Participants|||Number
717393|NCT00273754|Secondary|Occurence of Post Extubatory Respiratory Adverse Events.|The overall occurance of adverse post-extubation respiratory events, including laryngospasm, upper airway obstruction, apnea, desaturation (defined as decrease in oxygen saturation <95% while breathing oxygen via mask for any length of time) and need for reintubation, both in the OR and in the PACU was noted.|Time post extubation in OR and PACU until the patient was discharged from the PACU to go home or to a hospital room.|Per protocol||Participants|||Number
717394|NCT00273754|Primary|Number of Children Who Developed Postextubation Adverse Respiratory Events Compared to Placebo.|The number of children having adverse post-extubation respiratory events, including laryngospasm, upper airway obstruction, apnea, desaturation (defined as decrease in oxygen saturation <95% while breathing oxygen via mask for any length of time) and need for reintubation, both in the Operating Room and in the PACU was recorded.|Time post extubation in OR and PACU until the patient was discharged from the PACU to go home or to a hospital room.|The analysis was per protocol.||Participants|||Number
717395|NCT00273793|Secondary|Average Number Cigarettes Reported Smoked Each Day in the Past Week Measured at Follow-up Six Months After Entry Into the Study|average number cigarettes reported smoked each day in the past week at follow up six months after study entry|past week at follow-up six months after study entry|||cigarettes per day||Standard Deviation|Mean
717396|NCT00273793|Primary|Breath Carbon Monoxide Levels Indicating Smoking Abstinence During the Study, i.e., the Number of Breath Samples With Carbon Monoxide (CO) Levels Less Than 3 Parts Per Million (Ppm)||daily for breath CO|all subjects randomized to condition||number breath samples < 3 ppm CO||Inter-Quartile Range|Median
717397|NCT00273858|Secondary|Change From Baseline in Physician Global Assessment (PGA) VAS at 24 Month|PGA was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity to 100 mm = worst disease activity possible.|Baseline, Month 24|Data was not analyzed as the usage of the scale was not considered to be part of usual clinical practice at the time of the study and thus was not to be used in the framework of a non-interventional trial.||mm|||Number
717398|NCT00273858|Secondary|Change From Baseline in Patient Global Assessment (PtGA) Visual Analog Scale (VAS) at 24 Month|PtGA measured using a 100 mm VAS ranging from 0 = very good to 100 = very bad.|Baseline, Month 24|Data was not analyzed as the usage of the scale was not considered to be part of usual clinical practice at the time of the study and thus was not to be used in the framework of a non-interventional trial.||Millimetre (mm)|||Number
717399|NCT00273858|Secondary|Change From Baseline in Health Assessment Questionnaire (HAQ) at 24 Month|HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores as 'normal' (no difficulty=0), 'adequate' (some difficulty= 1), 'limited' (much difficulty=2), and 'unable to do' (=3) based on degree of difficulty they experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. HAQ total scores were expressed as overall mean score ranging from 0 to 3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; greater than 1=significant functional limitation.|Baseline, Month 24|Data was not analyzed as the usage of the questionnaire was not considered to be part of usual clinical practice at the time of the study and thus was not to be used in the framework of a non-interventional trial.||Units on a Scale|||Number
717400|NCT00273858|Primary|Number of Participants by Reasons for Discontinuation of Treatment||Baseline up to Month 24|Safety population included all participants who received at least one dose of etanercept.||Participants|||Number
717401|NCT00273858|Primary|Number of Participants Who Discontinued Treatment||Baseline up to Month 24|Safety population included all participants who received at least one dose of etanercept.||Participants|||Number
717402|NCT00273858|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Any untoward medical occurrence in a participant who received study drug was considered an AE, without regard to possibility of causal relationship. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a SAE: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to Month 24|Safety population included all participants who received at least one dose of etanercept.||Participants|||Number
717403|NCT00273910|Secondary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|48 months|||Participants|||Number
717404|NCT00273910|Primary|Immunologic Response Rate|Comparison of six different preparations of the gp100:209-217 (210M) melanoma antigen peptide. The arm with the greater number of immunologic responses will be the one most likely to be selected for future study on the basis of immunization alone. Evidence of immunization consist of at least 10 Elispots/100,000 cells above background. An injection site reaction is not an immune response.|48 months|The number of participants analyzed and results are correct. We do not have the immunologic response rate data for all patients.||Participants|||Number
717405|NCT00275821|Secondary|Mean Change From Baseline in Retinal Thickness at the Central Subfield of the Study Eye at Month 12|Optical Coherence Tomography (OCT) was performed on both eyes at screening and monthly from baseline through Month 12 prior to study drug administration. OCT images were evaluated at the central reading center (CRC) by trained graders and ophthalmologists experienced in clinical trials.|Baseline to Month 12|Intent to Treat (ITT) population, with use of Last Observation Carried Forward (LOCF), consisted of all patients randomized into the study. Patients were analyzed according to the treatment group to which they were randomized. Only patients with available data at baseline and Month 12 were included in the analysis.||Micrometers||Standard Deviation|Mean
717406|NCT00275821|Secondary|Mean Change From Baseline in Retinal Thickness at the Central Point of the Study Eye at Month 12|Optical Coherence Tomography (OCT) was performed on both eyes at screening and monthly from baseline through Month 12 prior to study drug administration. OCT images were evaluated at the central reading center (CRC) by trained graders and ophthalmologists experienced in clinical trials.|Baseline to Month 12|Intent to Treat (ITT) population, with use of Last Observation Carried Forward (LOCF), consisted of all patients randomized into the study. Patients were analyzed according to the treatment group to which they were randomized. Only patients with available data at baseline and Month 12 were included in the analysis.||micrometers||Standard Deviation|Mean
717484|NCT00276484|Secondary|Percent Change From Baseline to Week 6 in Total-Cholesterol|Percent Change in Total-C = [(week 6 value - baseline value)/baseline value]*100%|Baseline and 6 Weeks|Full Analysis Set||Percent Change||95% Confidence Interval|Least Squares Mean
717407|NCT00275821|Secondary|Mean Change From Baseline in the Total Lesion Area of the Study Eye at Month 12|Fluorescein angiography was conducted in conjunction with color fundus photography at screening and at Months 6 and 12. Investigators used digital fluorescein angiograms to determine presence or absence of choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD).|Baseline to Month 12|The intent to treat (ITT) population, with use of Last Observation Carried Forward (LOCF), consisted of all patients randomized into the study. Patients were analyzed according to the treatment group to which they were randomized. Only patients with available data at baseline and Month 12 were included in the analysis.||mm^2||Standard Deviation|Mean
717408|NCT00275821|Primary|Mean Change From Baseline in Best-corrected Visual Acuity of the Study Eye at Month 12|Visual acuity (VA) was assessed in both eyes at each study visit using best correction determined from protocol refraction. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at an initial testing distance of 4 meters.|Baseline to Month 12|Per-Protocol (PP) population includes a subset of patients from the Intent to Treat (ITT) population who completed Month 12/Visit 15, had an assessment of Best Corrected Visual Acuity in the study eye at Month 12/Visit 15 and did not have any major study protocol deviations.||letters||Standard Deviation|Mean
717409|NCT00275834|Secondary|Change in Blood Pressure||Baseline, 1 year|||mm Hg||95% Confidence Interval|Least Squares Mean
717410|NCT00275834|Secondary|Quality of Life as Measured by HADS_D|Hospital Anxiety and Depression Scale - Depression (HADS-D) The HADS is a 14-item self-administered questionnaire that consists of 2 scales, one measuring anxiety (HADS-A), and the other measuring depression (HADS-D). Each subscale consists of 7 statements and the participant responds as to how each item applies to him/her over the past week on 4-point response scale. Separate scores are calculated for anxiety and depression and a score (ranging from 0 to 21) is obtained for each subscale. The higher the score, the more severe the anxiety or depression.|1 year|||units on a scale||95% Confidence Interval|Least Squares Mean
717411|NCT00275834|Secondary|Change in Lipids||baseline, 1 year|||mg/dL||95% Confidence Interval|Least Squares Mean
717412|NCT00275834|Secondary|Inflammatory Markers (CRP)|C reactive Protein (CRP)|1 year|Participants who had CRP testing completed||mg/L||Standard Error|Mean
717413|NCT00275834|Secondary|Waist Circumference|Analyses was based on intent-to-treat ANCOVA. Difference scores from baseline to endpoint (Month-12) for each measure were regressed on the three-level proxy denoting group while controlling for the baseline value of the same measure. Contrasts were subsequently estimated in models, which had a significant overall treatment effect.|1 year|intent-to-treat||cm||95% Confidence Interval|Mean
717414|NCT00275834|Secondary|Proportions of Patients With 10% Weight Loss|This outcomes measure followed the same principles at measurement of proportions of patients with 5% weight loss described elsewhere.|1 year|||participants|||Number
717415|NCT00275834|Secondary|Proportions of Patients With 5% Weight Loss|These were the proportions of patients losing 5% or more weight at 1-year relative to baseline. The measures were modeled with logistic regressions that included the three-level group proxy and a baseline weight covariate.|1 year|||participants|||Number
717416|NCT00275834|Primary|Change in Body Weight|The primary endpoint was weight loss at 1-year, Month-12 weight minus baseline weight, in kilograms.|1 year|intent-to-treat||kg||95% Confidence Interval|Mean
717417|NCT00276016|Secondary|The Average Change From Baseline to Endpoint (6 Hours Post-dosing) in Nasal Congestion for Pseudoephedrine and Placebo.|"To estimate the effect of a pseudoephedrine (PSE) 60 mg immediate release tablet on nasal congestion over a 6-hour observation period relative to placebo
The values for the nasal congestion score scale are 0,1,2,3 for measure of symptoms, defined as 0-none, 1-mild, 2-moderate, 3-severe. They are subject-evaluated results."|Baseline to endpoint (6 hour period)|||Units on a scale||Standard Deviation|Mean
717418|NCT00276016|Primary|The Average Change From Baseline to Endpoint (6 Hours Post-dosing) in Nasal Congestion for Phenylephrine Compared With Placebo|"To evaluate the effect of phenylephrine 12-mg immediate-release capsule on nasal congestion in subjects with seasonal allergic rhinitis (SAR) who have been exposed to pollen for 6 hours in the Vienna Challenge Chamber (VCC). The average change from the Baseline was evaluated immediately before treatment start, over the first 6 hour post-dosing.
The values for the scale are 0,1,2,3 for measure of symptoms, defined as 0-none, 1-mild, 2-moderate, 3-severe. They are subject-evaluated results."|Baseline to endpoint (6 hour period)|||Units on a scale||Standard Deviation|Mean
717419|NCT00276094|Secondary|Change From Baseline in Urinary Symptoms||Baseline (Randomization) to Week 12|||Participants|||Number
717420|NCT00276094|Secondary|Change From Baseline in Testosterone (Total) Levels||Baseline (Screening) to Week 12|||ng/dL||Standard Deviation|Mean
717421|NCT00276094|Secondary|Change From Baseline in Testosterone (Free) Levels||Baseline (Screening) to Week 12|||ng/dL||Standard Deviation|Mean
717422|NCT00276094|Secondary|Change From Baseline in Sex Hormone Binding Globulin Levels||Baseline (Screening) to Week 12|||nmol/L||Standard Deviation|Mean
717423|NCT00276094|Secondary|Change From Baseline in Luteinizing Hormone Levels||Baseline (Screening) to Week 12|||IU/L||Standard Deviation|Mean
717424|NCT00276094|Secondary|Change From Baseline in Follicle Stimulating Hormone Levels||Baseline (Screening) to Week 12|||IU/L||Standard Deviation|Mean
717425|NCT00276094|Primary|Mean Change From Baseline in the Percentage of Superficial Cells in Maturation Index of Vaginal Smear||Baseline (Screening) to Week 12|||percentage of superficial cells||Standard Deviation|Mean
717426|NCT00276094|Secondary|Change From Baseline in Estradiol Levels||Baseline (Screening) to Week 12|"Analysis populations for each hormone:
Ospemifene(30 mg): E2-231, FSH-232, LH-231, SHBG-232, Testosterone(free)-183, Testosterone(total)-183 Ospemifene(60 mg): E2-221, FSH-222, LH-222, SHBG-221, Testosterone(free)-175, Testosterone(total)-176 Placebo: E2-216, FSH-216, LH-216, SHBG-216, Testosterone(free)-178, Testosterone(total)-178"||pg/mL||Standard Deviation|Mean
717427|NCT00276094|Secondary|Change From Baseline in Severity of VVA Symptoms|This outcome measure was analyzed using CMH row mean scores test controlling for study center and uterine status. VVA Symptom Score: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe|Baseline (Randomization) to Week 12|||Units on a scale||Standard Deviation|Mean
717428|NCT00276094|Secondary|Change From Baseline in Visual Evaluation of the Vagina|Exam Rating Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe|Baseline (Screening) to Week 12|||Units on a scale||Standard Deviation|Mean
717431|NCT00276094|Primary|Mean Change From Baseline in the MBS of Vaginal Pain Associated With Sexual Activity|This outcome measure was analyzed using CMH row mean scores test controlling for study center and uterine status. VVA Symptom Score: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe|Baseline (Randomization) to Week 12|||Units on a scale||Standard Deviation|Mean
717432|NCT00276094|Primary|Mean Change From Baseline in the Most Bothersome Vulvar and Vaginal Atrophy (VVA) Symptom (MBS) of Vaginal Dryness|This outcome measure was analyzed using Cochran-Mantel-Haenszel (CMH) row mean scores test controlling for study center and uterine status. VVA Symptom Score: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe|Baseline (Randomization) to Week 12|||Units on a scale||Standard Deviation|Mean
717433|NCT00276159|Secondary|Peak Concentrations of 852A|Measurement of peak concentrations of 852A to correlate the side effects of tolerability in patients.|Up to Week 12|Not able to analysis due to sale of agent - unable to perform.||ng/mL||Full Range|Mean
717434|NCT00276159|Secondary|Measure of Immune Activation With Correlative Laboratory Studies||Up to Week 12|Analysis not done to sale of agent - unable to perform.||IU/mL||Full Range|Mean
717435|NCT00276159|Secondary|Number of Patients Who Received Steroids|Number of patients who received steroids allowing successful continuation of therapy.|Up to Week 12|Includes patients receiving at least 12 doses of 852A study drug.||Participants|||Number
717436|NCT00276159|Primary|Number of Patients With 852A Response Using Modified Response Evaluation Criteria in Solid Tumors|Stable disease in Non-Hogkin's Lymphoma = disease that does not satisfy complete (complete regression), partial (> or = 50% reduction) or progressive disease (increase of 25%) by at least a 4-week period. Since Acute Myelogenous Leukemia is not a solid tumor, Complete Response (CR) = <5% blasts with hematopoietic recovery (absolute neutrophil count >500) at 4 weeks.|Up to Week 12|Includes patients receiving at least 12 doses of 852A study drug.||Participants|||Number
717437|NCT00276250|Secondary|Number of Subjects With Normal Renal Function, as Measured by Serum Creatinine Levels|Renal function was assessed by measuring levels of serum creatinine. Normal values range from 0.7 to 1.3 mg/dL for men and 0.6 to 1.1 mg/dL for women.|24 months after transplant|One subject in the Efalizumab followed by abatacept regimen arm withdrew from the the study at 18 months post-transplantation and therefore did not have the 24-month assessments.||participants|||Number
717438|NCT00276250|Secondary|The Number of Study Participants Exhibiting a Successful Response to a Standard Mixed Meal Test, Measured by Stimulated C-peptide Levels After Islet Transplant.|The number of study participants who have detectable C-peptide levels after stimulation from a Mixed Meal Test. An increase of C-peptide indicates that insulin is being released normally in response to food consumption.|1, 3, 6, 9,12,18 and 24 months post-transplantation|C-Peptide values were not obtained for 2 participants in the Efalizumab followed by abatacept arm for 18 and 24 months post-transplant||participants|||Number
717439|NCT00276250|Secondary|Number of Participants With Endogenous Insulin Production Post-transplant, Assessed by Fasting C-peptide Levels|The number of subjects exhibiting C-peptide levels ≥ 0.5 ng/mL was recorded.|1, 3, 6, 9,12,18 and 24 months post-transplantation|C-Peptide values were not obtained for 2 participants in the Efalizumab followed by abatacept arm at the 18 and 24 months post-transplant timepoints.||participants|||Number
717440|NCT00276250|Secondary|Number of Subjects With HbA1C < 6.5%|HbA1C was assessed in the subjects 36 months after transplantation and the number of subjects with values < 6.5% was recorded which indicated better control of blood glucose levels.|36 months post-transplantation|Two participants in the Efalizumab followed by abatacept regimen arm were terminated prior to this time point due to islet graft failure; another one withdrew as they did not want to change to abatacept. The single participant in the Abatacept arm withdrew after graft failure which occurred at 6months post-transplantation.||participants|||Number
717441|NCT00276250|Secondary|Number of Subjects With HbA1C < 6.5%|HbA1C was assessed in the subjects 24 months after transplantation and the number of subjects with levels < 6.5% was recorded which indicated better control of blood glucose levels.|24 months post-transplant|One participant in the Efalizumab followed by abatacept regimen arm had partial graft function and withdrew from the study at 18 months post-transplantation (prior to this time point of assessment).||participants|||Number
717442|NCT00276250|Secondary|Number of Subjects With HbA1C Levels < 6.5%|HbA1C was assessed in the subjects 12 months after transplantation and the number of subjects with levels < 6.5% was recorded which indicated better control of blood glucose levels.|12 months post-transplantation|||participants|||Number
717443|NCT00276250|Secondary|Number of Subjects With HbA1C Less Than 6.5%|HbA1C was assessed in the subjects 6 months after transplantation and the number of subjects with values less than 6.5% was recorded which indicated better control of blood glucose levels.|6 months post-transplantation|The HbA1C for the subject in the abatacept arm was above the threshold (6.5%) for this measure.||participants|||Number
717444|NCT00276250|Secondary|Number of Insulin-independent Subjects Following Islet Transplantation|Participants who did not need to take insulin at 1, 3, 6, 9, 12, 18, and 24 months following islet transplantation|1, 3, 6, 9,12,18 and 24 months post-transplantation|||participants|||Number
717445|NCT00276250|Primary|The Number of Insulin-independent Subjects at Day 75 (± 5 Days) Following the First Islet Cell Transplantation||75 days post-transplantation|||participants|||Number
717446|NCT00276406|Secondary|QTc Interval Before and After Treatment|The corrected QT interval (QTc) is a measurement of time (seconds) between the Q and T waves of an heart beat as recorded during an Electrocardiogram (ECG).|Baseline period (9 days), Treatment period (7 days)|||Milliseconds||Standard Error|Mean
717447|NCT00276406|Secondary|Heart Rate Before and After Treatment|Heart rate is the number of beats per minute, as recording on an Electrocardiogram (ECG).|Baseline period (9 days), Treatment period (7 days)|||beats per minute||Standard Error|Mean
717448|NCT00276406|Secondary|Stool Frequency Per Week|During 9 days of the baseline period and during 17 days of the treatment period, subjects used a daily diary to record the number of times per day they had a bowel movement. Complete spontaneous bowel movements per week are reported. Only the 7 days of highest treatment dose will be used for comparison purposes.|Daily during baseline period (9 days), Treatment period (7 days)|||Number complete bowel movements per week||Standard Error|Mean
717449|NCT00276406|Secondary|Sense of Completely Emptying Bowels|During 9 days of the baseline period and during 17 days of the treatment period, subjects used a daily diary to record whether or not they felt they had completely emptied their bowels(1= Yes; 0= No). Only the 7 days of highest treatment dose will be used for comparison purposes.|Daily during baseline period (9 days), Treatment period (7 days)|||percentage of bowel movements||Standard Error|Mean
717450|NCT00276406|Secondary|Stool Ease of Passage|During 9 days of the baseline period and during 17 days of the treatment period, subjects used a daily diary to record a description of stool ease of passage of stool, according to the Bristol Stool Form Scale (ranging from 1 (manual disimpaction) to 7 (incontinence)). Only the 7 days at highest treatment dose will be used for comparison purposes.|Daily during baseline period (9 days), Treatment period (7 days)|||units on a scale||Standard Error|Mean
717451|NCT00276406|Secondary|Stool Form/Consistency|"During 9 days of the baseline period and during 17 days of the treatment period, subjects used a daily diary to record a description of stool consistency according to the Bristol Stool Form Scale (ranging from 1 (hard lumps) to 7 (watery)). The Bristol Stool Scale is a medical aid designed to classify the form of human feces into seven categories or types. Types 1 and 2 indicate constipation with 3 and 4 being the ideal stools especially the latter, as they are the easiest to defecate, and 5-7 tending towards diarrhea."|Daily during baseline period (9 days), Treatment period (7 days)|||units on a scale||Standard Error|Mean
717452|NCT00276406|Secondary|Stool Frequency Per Day|During 9 days of the baseline period and during 17 days of the treatment period, subjects used a daily diary to record the number of times per day they had a bowel movement. Only the 7 days of highest treatment dose will be used for comparison purposes.|Daily during baseline period (9 days), Treatment period (7 days)|||Number of bowel movements||Standard Error|Mean
717453|NCT00276406|Secondary|Colonic Geometric Center at 48 Hours (GC48) as Measured by Scintigraphy|The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly for the first 6 hours after the radio-labeled meal, then at 8, 24 and 48 hours. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool. GC48 is the measurement taken at 48 hours after the radio-labeled meal.|Baseline period (days 7-9 ), Treatment period (days 14-17)|||units on a scale||Standard Error|Mean
717454|NCT00276406|Secondary|Colonic Filling at 6 Hours|The proportion of a radio-labeled meal in the colon at 6 hours (identifiable by radio-labelled tracer to capsule eaten with meal), measured by scintigraphy. This is an indirect measurement of small-bowel transit time.|Baseline period (9 days), Treatment period (7 days)|||percentage of meal||Standard Error|Mean
717455|NCT00276406|Secondary|Gastric Emptying Half-time (GE t1/2)|The measure of time for 50 percent of a radio-labeled meal to empty from the stomach.|Baseline period (9 days), Treatment period (7 days)|||minutes||Standard Error|Mean
717456|NCT00276406|Primary|Ascending Colon Emptying Half-time (AC t1/2) Measured in Hours|Calculated by linear interpolation of values on the AC emptying curve.|Baseline period (days 7-9 ), Treatment period (days 14-17)|||hours||Standard Error|Mean
717457|NCT00276406|Primary|Colonic Geometric Center at 24 Hours (GC24) Measured by Scintigraphy|The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images of the abdomen are taken hourly for the first 6 hours after the radio-labeled meal, then at 8, 24 and 48 hours. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool. GC24 is the measurement taken at 24 hours after the radio-labeled meal.|Baseline period (days 7-9 ), Treatment period (days 14-17)|||units on a scale||Standard Error|Mean
717458|NCT00276419|Secondary|Mean Days of Pain During the 10 Week Treatment Periods|Participants will complete a breast pain diary indicating the sensation of pain on a daily basis. Mean number of days with pain during each 10 week treatment period will be calculated.|Approximately 12 weeks and at 24 weeks after randomization||||||
717459|NCT00276419|Primary|Severity of Breast Pain|Severity will measured using a 100 mm visual analog scale (VAS). The VAS does not have any pre-set marks between the extremes. For the pain severity VAS, 0 means no pain and 100 means extreme pain. The investigator measures the written mark of the participant in mm, and records this for the value of pain severity. The severity of breast pain will be determined by the mean of breast pain scores (determined for all days and for days for which pain is greater than 0) at 4 weeks and 10 weeks of each treatment.|4 weeks, 10 weeks||||||
717460|NCT00276419|Primary|Frequency of Breast Pain|Participants will complete a breast pain diary indicating the sensation of pain on a daily basis. The frequency of breast pain will be determined by the number of days per week that the subject recorded experiencing pain at 4 weeks and 10 weeks of each treatment.|4 weeks, 10 weeks||||||
717461|NCT00276458|Secondary|Number of Participants Who Attained Target LDL-C <100 mg/dL at Week 6||6 weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Participants|||Number
717462|NCT00276458|Post-Hoc|Percent Change in C-Reactive Protein (CRP) at Week 6|[(6 week value – baseline value)/baseline value]*100%.|6 weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent||95% Confidence Interval|Least Squares Mean
717463|NCT00276458|Secondary|Percent Change From Baseline in C-Reactive Protein (CRP) at Week 6|[(6 week value – baseline value)/baseline value]*100%.|6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||percent||95% Confidence Interval|Least Squares Mean
717464|NCT00276458|Secondary|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (HDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6|[(6 week value – baseline value)/baseline value]*100%.|6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent||95% Confidence Interval|Least Squares Mean
717465|NCT00276458|Secondary|Percent Change From Baseline in Apolipoprotein B: Apolipoprotein A-I Ratio at Week 6|[(6 week value – baseline value)/baseline value]*100%.|6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent||95% Confidence Interval|Least Squares Mean
717466|NCT00276458|Secondary|Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6|[(6 week value – baseline value)/baseline value]*100%.|6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent||95% Confidence Interval|Least Squares Mean
717467|NCT00276458|Secondary|Percent Change From Baseline in Total-Cholesterol:High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6|[(6 week value – baseline value)/baseline value]*100%.|6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent||95% Confidence Interval|Least Squares Mean
717468|NCT00276458|Post-Hoc|Percent Change in Apolipoprotein A-I at Week 6|[(6 week value – baseline value)/baseline value]*100%.|6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent||95% Confidence Interval|Least Squares Mean
717469|NCT00276458|Secondary|Percent Change From Baseline in Apolipoprotein B at Week 6|[(6 week value – baseline value)/baseline value]*100%.|6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent||95% Confidence Interval|Least Squares Mean
717470|NCT00276458|Secondary|Percent Change From Baseline in Triglycerides (TG) at Week 6|[(6 week value – baseline value)/baseline value]*100%.|6 weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent||95% Confidence Interval|Least Squares Mean
717471|NCT00276458|Secondary|Percent Change From Baseline in Total-Cholesterol at Week 6|([6 week value – baseline value)/baseline value]*100%.|6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||percent||95% Confidence Interval|Least Squares Mean
717472|NCT00276458|Secondary|Percent Change in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6|[(6 week value – baseline value)/baseline value]*100%.|6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent||95% Confidence Interval|Least Squares Mean
717473|NCT00276458|Secondary|Percent Change in High Density Lipoprotein -Cholesterol (HDL-C)at Week 6|[(6 week value – baseline value)/baseline value]*100%.|6 weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent||95% Confidence Interval|Least Squares Mean
717474|NCT00276458|Primary|Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Week 6|[(6 week value – baseline value)/baseline value]*100%.|6 weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent||95% Confidence Interval|Least Squares Mean
717475|NCT00276484|Secondary|Number of Patients Who Attained Target Low-Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 6||6 Weeks|Full Analysis Set||Participants|||Number
717476|NCT00276484|Secondary|Percent Change From Baseline to Week 6 in C Reactive Protein (CRP)|Percent Change in CRP = [(week 6 value - baseline value)/baseline value]*100%|Baseline and 6 Weeks|Full Analysis Set||Percent Change||95% Confidence Interval|Least Squares Mean
717477|NCT00276484|Secondary|Percent Change From Baseline to Week 6 in Non-High-Density Lipoprotein-Cholesterol:High-Density Lipoprotein-Cholesterol (Non-HDL-C:HDL-C) Ratio|Percent Change in non-HDL-C:HDL-C Ratio = [(week 6 ratio - baseline ratio)/baseline ratio]*100%|Baseline and 6 Weeks|Full Analysis Set||Percent Change||95% Confidence Interval|Least Squares Mean
717478|NCT00276484|Secondary|Percent Change From Baseline to Week 6 in Apolipoprotein B:Apolipoprotein A-I (Apo B:Apo A-I) Ratio|Percent Change in Apo B:Apo A-I Ratio = [(week 6 ratio - baseline ratio)/baseline ratio]*100%|Baseline and 6 Weeks|Full Analysis Set||Percent Change||95% Confidence Interval|Least Squares Mean
717479|NCT00276484|Secondary|Percent Change From Baseline to Week 6 in Low-Density Lipoprotein-Cholesterol:High-Density Lipoprotein-Cholesterol (LDL-C:HDL-C) Ratio|Percent Change in LDL-C:HDL-C Ratio = [(week 6 ratio - baseline ratio)/baseline ratio]*100%|Baseline and 6 Weeks|Full Analysis Set||Percent change||95% Confidence Interval|Least Squares Mean
717480|NCT00276484|Secondary|Percent Change From Baseline to Week 6 in Total-Cholesterol (TC):High-Density Lipoprotein Cholesterol (HDL-C) Ratio|Percent Change in TC:HDL-C Ratio = [(week 6 ratio - baseline ratio)/baseline ratio]*100%|Baseline and 6 Weeks|||Percent Change||95% Confidence Interval|Least Squares Mean
717481|NCT00276484|Secondary|Percent Change From Baseline to Week 6 in Apolipoprotein A-I (Apo A-I)|Percent Change in Apo A-I = [(week 6 value - baseline value)/baseline value]*100%|Baseline and 6 Weeks|Full Analysis Set||Percent Change||95% Confidence Interval|Least Squares Mean
717485|NCT00276484|Secondary|Percent Change From Baseline to Week 6 in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C)|Percent Change in Non-HDL-C = [(week 6 value - baseline value)/baseline value]*100%|Baseline and 6 Weeks|Full Analysis Set||Percent Change||95% Confidence Interval|Least Squares Mean
717486|NCT00276484|Secondary|Percent Change From Baseline to Week 6 in High-Density Lipoprotein Cholesterol (HDL-C)|Percent Change in HDL-C = [(week 6 value - baseline value)/baseline value]*100%|Baseline and 6 weeks|Full Analysis Set||Percent Change||95% Confidence Interval|Least Squares Mean
717487|NCT00276484|Primary|Percent Change From Baseline to Week 6 in Low-Density Lipoprotein (LDL)-C|Percent Change in LDL-C = [(week 6 value - baseline value)/baseline value]*100%|Baseline and 6 weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
717488|NCT00276549|Primary|Number of Patients With Measurable Soft Tissue Disease Will be Assessed Per Solid Tumor Response Criteria (RECIST).|Patients who have a response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) by RECIST criteria. To be assigned a status of PR or CR, changes in tumor measurements must be confirmed by repeat assessments that should be performed no less than 4 weeks after the criteria for response are first met. In the case of SD, patients who do not meet the criteria for response or progressive disease for at least 90 days will be categorized as stable disease.|at 4 weeks after treatment completion|25 patients had RECIST defined measurable disease at study entry. Confirmed response required 2 consecutive measurements at least 1 week later.Three patients did not have follow up measurements therefore were not evaluable.||participants|||Number
717489|NCT00276549|Primary|Objective PSA Response Rate (Number of Patients With a PSA Response)|Decline from a baseline value by ≥ 50% or normalization of PSA (< 0.03) confirmed by a second measurement at least 1 week or more weeks later. Patients must not demonstrate clinical or radiographic evidence of disease progression during this time period. The date of response will be defined as the first date at which the PSA declined from baseline by ≥ 50% or normalized.|every 4 weeks|All patients that received treatment.||participants|||Number
717490|NCT00276614|Primary|Objective Response Rate as Measured by RECIST Criteria After Every 2 Courses of Treatment for up to 6 Courses||2 months|2 subjects were excluded from analysis as they completed less than 2 cycles of study therapy.||participants|||Number
717491|NCT00276861|Secondary|Time to Progression as Measured by the Kaplan Meyer Curve at Completion of Study Treatment|Number of months from time of enrollment to the date of first documented progression or date of death.|6 months|||months||95% Confidence Interval|Number
717492|NCT00276861|Primary|Response Rate as Measured by RECIST Criteria|Complete Response (CR) or Partial Response (PR) as defined by RECIST v 1.0 criteria.|4 - 6 months|||percentage of particpants||95% Confidence Interval|Number
717493|NCT00277095|Primary|Primary Efficacy: Demonstrate the Efficacy of the ProACT Device in Reducing Incontinence as Measured by the 24-hour Pad Weight at 18 Months Compared to Baseline. A Subject is a Success if he Demonstrates a 50% Reduction.|The percentage of participants with 50% reduction in pad weight.|18 month follow-up|As followed analysis of all patients who were treated and reached the 18 month follow-up visit||percentage of patients||95% Confidence Interval|Number
717494|NCT00277212|Secondary|Adjusted Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment,|The Barnes Akathisia Rating Scale is a 4-item scale to assess presence and severity of drug-induced akathisia, including both objective items and subjective items, together with a global clinical assessment of akathisia. Global assessment is made on a scale of 0 to 5 with comprehensive definitions provided for each anchor point on scale: 0=absent; 1=questionable; 2=mild akathisia; 3=moderate akathisia; 4=marked akathisia; 5=severe akathisia. Score has a possible range from 0 (absent) to 5 (severe akathisia). Negative change scores indicate improvement in akathisia.|Baseline, Weeks 8, 24, 36, 52|Observed cases (OC) data set (actual observation at each visit), Last observation carried forward (LOCF) data set (data recorded at a given visit or, if no observation is recorded at that visit, data carried forward from the previous visit). n=number of participants analyzed at timepoint.||units on a scale||Standard Error|Mean
717495|NCT00277212|Secondary|Adjusted Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score|The AIMS is an assessment of movement dysfunctions. It is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs and 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in 3 main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe). The AIMS Total Score has a possible range from 0 to 28. Negative change scores indicate improvement in movement dysfunction.|Baseline, Weeks 8, 24, 36, 52|Observed cases (OC) data set (actual observation at each visit), Last observation carried forward (LOCF) data set (data recorded at a given visit or, if no observation is recorded at that visit, data carried forward from the previous visit). n=number of participants analyzed at timepoint.||units on a scale||Standard Error|Mean
717496|NCT00277212|Secondary|Adjusted Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score|The SAS is a 10-item instrument used to evaluate the presence and severity of parkinsonian symptomatology. The ten items focus on rigidity rather than bradykinesia, and do not assess subjective rigidity or slowness. Items are rated for severity on a 0-4 scale, with definitions given for each anchor point. The total SAS Score has a possible range from 10 to 50. Negative change scores indicate improvement.|Baseline, Weeks 8, 24, 36, 52|Observed cases (OC) data set (actual observation at each visit), Last observation carried forward (LOCF) data set (data recorded at a given visit or, if no observation is recorded at that visit, data carried forward from the previous visit). n=number of participants analyzed at timepoint.||units on a scale||Standard Error|Mean
717497|NCT00277212|Secondary|Summary of Concomitant Medications, Phase 2||Phase 2 (52 Week Double-blind Relapse Assessment Phase)|Phase 2 Safety Sample (all patients who are randomized into Phase 2 and take at least one dose of double-blind medication in Phase 2, as indicated on the study therapy form).||participants|||Number
717498|NCT00277212|Secondary|Summary of Concomitant Medications, Phase 1||Phase 1 (9 to 24 Week Single-blind Stabilization Phase)|Phase 1 Safety Sample (all patients who take at least one dose of singleblind aripiprazole in Phase 1, as indicated on the study therapy form).||participants|||Number
721300|NCT00307086|Primary|Overall Survival (OS)|Median overall survival after first peripheral blood stem cell transplant (PBSCT).|40 months post transplant|All evaluable participants||months||95% Confidence Interval|Median
717499|NCT00277212|Secondary|Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities Occurring During Double-Blind Treatment (Phase 2)|Chemistry, hematology, and urinalysis abnormalities.Abbreviations used: alanine aminotransferase (ALT), institutional upper limit of normal (ULN), aspartate aminotransferase (AST), alkaline phosphatase (ALP), lactate dehydrogenase (LDH), high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), baseline (BL)|Throughout Phase 2 of the study, up to Week 52|Phase 2 safety sample||particiapnts|||Number
717500|NCT00277212|Secondary|Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities Occurring During Double-Blind Treatment|In order to be identified as clinically relevant abnormal, an on-drug value must meet the Criterion Value (CV) and also represent a change from the patient’s pretreatment value of at least the Change Relative to Baseline (CRB) magnitude. Heart Rate CV: 120 beats per minute (bpm), CRB: increase of ≥15 / CV: 50 bpm, CRB: decrease of ≥15. Systolic BP CV: 180 mmHg, CRB: increase of ≥20 / CV: 90 mmHg, CRB: decrease of ≥20. Diastolic BP CV: 105 mmHg, CRB: increase of ≥15 / CV: 50 mmHg, CRB: decrease of ≥15.|Up to 52 Weeks|Phase 2 Safety Sample (all patients who are randomized into Phase 2 and take at least one dose of double-blind medication in Phase 2, as indicated on the study therapy form).||participants|||Number
717501|NCT00277212|Secondary|Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities Occurring During Double-Blind Treatment|Abbreviations and further description used in table: Sinus tachycardia, ≥120 beats per minute (bpm) and ↑ ≥15 bpm & no current diagnosis of supraventricular or ventricular tachycardia/atrial fibrillation (AF)/atrial flutter/ other rhythm abnormality. Sinus bradycardia, ≤ 50 bpm and ↓ 15 bpm & no current diagnosis of AF/atrial flutter/other rhythm abnormality. Supraventricular premature beat (SPB), Ventricular premature beat (VPB), Atroventricular (A-V). Other intraventricular block, QRS ≥0.12 sec and ↑ ≥0.02 sec & no current diagnosis of left or right bundle branch block.|Throughout the study, up to Week 52|Participants with ECG evaluation from the phase 2 Safety Sample (all patients who are randomized into Phase 2 and take at least one dose of double-blind medication in Phase 2, as indicated on the study therapy form.)||particiapnts|||Number
717502|NCT00277212|Secondary|Adjusted Mean Change From Baseline in BMI by Study Week|Adjusted for index mood episode and baseline assessment.|Baseline, Weeks 12, 24, 36, 52|Observed cases (OC) data set (actual observation at each visit), Last observation carried forward (LOCF) data set (data recorded at a given visit or, if no observation is recorded at that visit, data carried forward from the previous visit), and Overall, Phase 2 Safety Sample; n=number assessed at given time point.||kg/m2||Standard Error|Mean
717503|NCT00277212|Secondary|Number of Participants Showing Clinically Relevant Weight Gain by Study Week|Weight gain of at least a 7% increase from Baseline.|Weeks 12, 24, 36, 52|Observed cases (OC) data set (actual observation at each visit), Last observation carried forward (LOCF) data set (data recorded at a given visit or, if no observation is recorded at that visit, data carried forward from the previous visit), and Overall, Phase 2 Safety Sample; n=number assessed at given time point.||Participants|||Number
717504|NCT00277212|Secondary|Number of Participants Showing Clinically Relevant Weight Loss by Study Week|Weight Loss of at least a 7% decrease from Baseline.|Weeks 12, 24, 36, 52|Observed cases (OC) data set (actual observation at each visit), Last observation carried forward (LOCF) data set (data recorded at a given visit or, if no observation is recorded at that visit, data carried forward from the previous visit), and Overall, Phase 2 Safety Sample; n=number assessed at given time point.||Participants|||Number
717505|NCT00277212|Secondary|Adjusted Mean Change From Baseline in Body Weight, Phase 2|Adjusted for index mood episode and baseline assessment|Baseline, Week 52|Participants from the phase 2 Safety Sample who had body weight evaluation at baseline and week 52 LOCF.||kg||Standard Error|Mean
717506|NCT00277212|Secondary|Deaths, Treatment-Emergent Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation of Study Medication, Treatment-Emergent AEs and Treatment-Emergent Extrapyramidal Syndrome (EPS)-Related AEs|AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|Throughout Phase 2 (up to 52 weeks)|The Phase 2 Safety Sample comprises all patients who are randomized into Phase 2 and take at least one dose of double-blind medication in Phase 2, as indicated on the study therapy form.||participants|||Number
717507|NCT00277212|Secondary|Proportion of Participants Without Discontinuation for Any Reason in the Double-blind Relapse Assessment Phase (Phase 2)|Proportion of Participants without Discontinuation Through Week 52(Kaplan-Meier's estimated survival rate).|Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|Randomized Participants (comprises all patients who are randomized in Phase 2). n= number of randomized participants evaluated at given time point.||Proportion of Participants|||Number
717508|NCT00277212|Secondary|Proportion of Participants Not Experiencing a Depressive Relapse in the Double-blind Relapse Assessment Phase (Phase 2)|Proportion of Participants without Relapse Through Week 52 (Kaplan-Meier's estimated survival rate).|Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|Randomized Participants (comprises all patients who are randomized in Phase 2). n= number of randomized participants evaluated at given time point.||Proportion of Participants|||Number
717509|NCT00277212|Secondary|Proportion of Participants Not Experiencing Relapse (Manic, Mixed, Depressive) in the Double-blind Relapse Assessment Phase Phase 2|Proportion of Participants without Relapse Through Week 52 (Kaplan-Meier's estimated survival rate).|Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|Randomized Participants (comprises all patients who are randomized in Phase 2). n= number of randomized participants evaluated at given time point.||Proportion of Participants|||Number
717510|NCT00277212|Primary|Proportion of Participants Not Experiencing Relapse Through Week 52 in the Double-Blind Relapse Assessment Phase (Phase 2)|Time from randomization to relapse to a manic or mixed episode in the Double-Blind Relapse Assessment Phase as measured by the Proportion of Participants without Relapse Through Week 52 (Kaplan-Meier's estimated survival rate).|Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|Randomized Participants (comprises all patients who are randomized in Phase 2). n= number of randomized participants evaluated at given time point.||Proportion of Participants|||Number
717511|NCT00277355|Secondary|Change From Baseline to Month 18 in the Total Functional Capacity (TFC) Scale [Regression Based Multiple Imputation Method]|TFC consists of five ordinally scaled items assessing a person’s capacity with: (1) occupation; (2) financial affairs; (3) domestic responsibilities; (4) activities of daily living; and (5) independent living. Total score ranges from zero (worst) to 13 (best). Regression based imputation was used to impute missing values.|Baseline to 18 months|The primary analyses were performed according to the intent to treat principle and included all randomized subjects. Two strategies were used to address missing data: 1. Last observation carried forward (LOCF) was used to impute missing values and 2. A secondary method of regression-based multiple imputation was also used.||units on a scale||Standard Deviation|Mean
717512|NCT00277355|Primary|Change From Baseline to Month 18 in the Total Functional Capacity (TFC) Scale [LOCF Imputation Method]|Establish preliminary estimate of minocycline's impact on progression of HD (measured by the change in Total Functional Capacity (TFC) score of Unified Huntington's Disease Rating Scale [UHDRS] between baseline & Month 18), and to assess futility of further study of minocycline. TFC consists of five ordinally scaled items assessing a person's capacity with: 1. occupation 2. financial affairs 3. domestic responsibilities 4. activities of daily living and 5. independent living. Total score ranges from zero (worst) to 13 (best).|Baseline to 18 months|The primary analyses were performed according to the intent to treat principle and included all randomized subjects. Two strategies were used to address missing data: 1. Last observation carried forward (LOCF) was used to impute missing values and 2. A secondary method of regression-based multiple imputation was also used.||units on a scale||Standard Deviation|Mean
717513|NCT00277394|Secondary|Number of Patients With Major Bleeding Events||prior to day 90 +/- 5|2 patients randomised to the Heparin group withdrew their consent just after randomisation and before taking any study treatment. No data were collected after visit 1, and due to the nature of the withdrawal, no further information was possible to collect. These patients were excluded from all analyses||Patients|||Number
717514|NCT00277394|Secondary|Number of Patients With Recurrence of Venous Thromboembolism||prior to day 90 +/- 5|2 patients randomised to the Heparin group withdrew their consent just after randomisation and before taking any study treatment. No data were collected after visit 1, and due to the nature of the withdrawal, no further information was possible to collect. These patients were excluded from all analyses||Patients|||Number
717515|NCT00277394|Primary|Number of Patients With Clinically Relevant Bleeding Events||prior to day 90 +/- 5|2 patients randomised to the Heparin group withdrew their consent just after randomisation and before taking any study treatment. No data were collected after visit 1, and due to the nature of the withdrawal, no further information was possible to collect. These patients were excluded from all analyses||Patients|||Number
717516|NCT00277446|Secondary|Forced Expiratory Volume in One Second (FEV1)|Forced expiratory volume in one second (FEV1) measured as liters/second|0 and 4 weeks|||liters/sec||Standard Deviation|Mean
717517|NCT00277446|Secondary|Eosinophil LTC4 Synthesis|Peripheral blood eosinophils were isolated before and after treatment with Novasoy, stimulated with calcium ionophore, and the amount of leukotriene C4 (LTC4) produced was measured by EIA.|0 and 4 weeks|||ng/ml||Standard Deviation|Mean
717518|NCT00277446|Primary|Exhaled Nitric Oxide|Exhaled nitric oxide at baseline (week 0) and at 4 weeks|0 and 4 weeks|Per protocol||parts per billion (ppb)||Standard Deviation|Mean
717519|NCT00277524|Primary|ICD/CRT-D Device Baseline Programming Measurements|"ICD/CRT-D baseline programming measurements, detection interval. Implanted Cardioverter/Defibrillator paces a patient's heart in a tachyarrhythmia prevention-pacing mode.
Detection intervals are used to detect atrial tachyarrhythmia. Detection Intervals are programmable heart rate thresholds. R-R intervals that are less than the VT or VF detection intervals (in ms) are considered evidence of VT or VF, respectively. R-R intervals that are between the FVT and the VF detection intervals are considered evidence of FVT. Thus, these detection interval thresholds demarcate rate zones of detection. The rate zones are used to determine the type of therapy applied once detection occurs."|Baseline|||ms||Standard Deviation|Mean
717520|NCT00277524|Secondary|Frequencies of Subjects With OptiVol Trends and Disease Progression.|"Estimate the correlation between OptiVol trends and disease progression.
A subject’s disease status was said to have progressed if:
The NYHA classification number increases (example: I to II), or
The LVEF decreases by at least 20% (relative difference) and by at least a 5% absolute difference, or
The subject expires
A subject who crossed OptiVol threshold since last visit was regarded as 'crossed threshold'."|4 years post implant|||participants|||Number
717521|NCT00277524|Secondary|"Compare First Shock Rate Between Medtronic PainFREE Programming and SCD-HeFT Programming in Primary Prevention Study Participants."|"First shock rate for VF and FVT zones was estimated using Kaplan-Meier method.
OMNI “PainFREE” definition: programming combinations that result in ATP therapy for ventricular tachycardia (VT) at cycle lengths <320 ms. Programming at cycle lengths ≥320 ms were not mandated.
OMNI “SCD-HeFT” definition: programming combinations that result in shock therapy only for arrhythmias at cycle lengths of <320 ms or faster and no therapy for arrhythmias at cycle lengths ≥320 ms."|4 years post implant|||rate||Standard Deviation|Mean
717522|NCT00277524|Secondary|Summary of ATP Episodes Within All Treated Episodes|Evaluate the utility of the Antitachycardia Pacing (ATP) During Charging feature of the device.|4 years post enrollment|||Episodes|||Number
717523|NCT00277524|Secondary|AV Block Status by Severity of Historical AV Block|Frequencies of Subjects with AV Block Over Time by Severity of Historical AV Block|4 years post implant|||participants|||Number
717524|NCT00277524|Secondary|AV Block Status by Device Type at 6 and 12 Months.|Frequencies of subject with AV block over time between ICD and Implantable Pulse Generator(IPG) study participants.|12 months post enrollment|||participants|||Number
717525|NCT00277524|Primary|ICD/CRT-D Device Baseline Programming Frequencies|ICD/CRT-D baseline programming, pacing mode and detection. Pacing mode is based on the NASPE/BPEG Generic (NBG) Pacemake coding which includes: I, the chambers paced (V= Ventricle, A=Atrium, D=Dual (A&V), O=None); II, the chambers sensed (V= Ventricle, A=Atrium, D=Dual (A&V), O=None); III, the mode of response (T=Triggered, I=Inhibited, D=Dual Triggered/Inhibited, O=None); IV, the programmable functions(R=Rate Modulated, C=Communicating, M=Multiprogrammable, P=Simple Programmable, O=None); V, the antitachycardia functions (O=None, P=Paced, S=Shocks, D=Dual (P&S)). In addition, MVP (managed ventricular pacing) is a mode that promotes AV conduction by reducing or eliminating unnecessary RV pacing but maintains dual chamber ventricular support in the event that AV conduction is lost.|Baseline|||participants|Participants||Number
717526|NCT00277524|Primary|Implantable Pulse Generator (IPG) Device Baseline Programming Frequencies.|Pacing mode is based on the NASPE/BPEG Generic (NBG) Pacemake coding which includes: I, the chambers paced (V= Ventricle, A=Atrium, D=Dual (A&V), O=None); II, the chambers sensed (V= Ventricle, A=Atrium, D=Dual (A&V), O=None); III, the mode of response (T=Triggered, I=Inhibited, D=Dual Triggered/Inhibited, O=None); IV, the programmable functions(R=Rate Modulated, C=Communicating, M=Multiprogrammable, P=Simple Programmable, O=None); V, the antitachycardia functions (O=None, P=Paced, S=Shocks, D=Dual (P&S)). In addition, MVP (managed ventricular pacing) is a mode that promotes AV conduction by reducing or eliminating unnecessary RV pacing but maintains dual chamber ventricular support in the event that AV conduction is lost.|Baseline|||participants|||Number
717527|NCT00277524|Primary|Implanted Systems Frequencies|Frequencies of implanted systems were measured among patients who were implanted with a device (IPT, ICD or CRT-D).|Baseline|||participants|||Number
717528|NCT00278343|Secondary|Incidence of Toxicity Graded According to National Cancer Institution Common Terminology Criteria for Adverse Events Version 3.0||Up to 4 years||||||
717529|NCT00278343|Secondary|Duration of Overall CA-125 Response|Confirmed response on CA125 - defined as reduction in level of pre-treatment sample by > 50%.|Up to 4 years|"1 confirmed PR observed in PS group. Response will be defined as reduction in level of pre-treatment sample by > 50%.
0 confirmed PR observed in PR group."||weeks|||Number
717530|NCT00278343|Secondary|Progression-free Survival (PFS)|The Kaplan-Meier method will be used to estimate PFS. Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion or the appearance of new lesions.|Time from start of treatment to time of progression, assessed up to 6 months|||months||95% Confidence Interval|Median
717531|NCT00278343|Secondary|Overall Survival (OS) (Discontinued as of 4/25/2014)|The Kaplan-Meier method will be used to estimate OS. Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible.|From date of radomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 32 months.|||months||95% Confidence Interval|Median
717532|NCT00278343|Secondary|Time to Disease Progression|Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible.|Up to 4 years||||||
717533|NCT00278343|Primary|Response Benefit (Complete Response or Partial Response or Stable Disease) Based on the RECIST/Rustin Criteria|Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions; Overall Response(OR) = CR+PR|After 16 weeks|Total # of Patients 74 PL-S (platinum sensitive) 39 patients PL-R (platinum resistant) 35 patients Confirmed PR PL-S group 9/39 patients Confirmed PR PL-R group 0/35 patients||participants|||Number
717534|NCT00278395|Secondary|Safety and Tolerability||1 year||||||
717535|NCT00278395|Secondary|Overall Survival (OS) and Median OS||1 year||||||
717536|NCT00278395|Secondary|Progression-free Survival||1 year||||||
717537|NCT00278395|Primary|Objective Response|"Objective response is measured using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in RECIST criteria.
Complete Response (CR) - Disappearance of all target lesions, Partial Response (PR) - at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, Progressive Disease (PD) - At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, Stable Disease (SD) - Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started."|1 year|The overall duration of response will be estimated using the Kaplan-Meier method for all patients who presented with an objective response.||participants|||Number
717538|NCT00270634|Secondary|A Composite of Biopsy-proven Chronic Rejection Graft Loss, Death, or Lost to Follow up.||Six months|Per Protocol Dataset||Percentage of patients|||Number
717539|NCT00270634|Secondary|Hypertension, Hyperlipidemia, or Hyperglycemia||Six months|Endpoint||Percentage of patients|||Number
717540|NCT00270634|Secondary|Graft Survival||Six months|||Percentage of patients|||Number
717541|NCT00270634|Secondary|Patient Survival||Six months|||Percentage of patients|||Number
717542|NCT00270634|Secondary|The Pharmacokinetic-pharmacodynamic Relationship Between Voclosporin and Calcineurin Inhibition (CNi), or Tacrolimus and Calcineurin Inhibition|"A sparse sampling protocol of whole blood samples obtained on Day 180 at time points immediately prior to drug administration and at 1, 2, and 4 hours post‐dose were utilized.
Standard non‐compartmental analysis (NCA) was performed on whole blood concentration data for voclosporin and its metabolites, tacrolimus, MPA (mycophenolic acid) and MPAG (mycophenolic acid glucuronide). Tmax and Cmax were obtained directly from the concentration‐time profiles without interpolation. AUC(0‐4)[area under the curve] was calculated using log‐linear trapezoidal rule. Cmax, AUC(0‐4), C0 and C2 were summarized using descriptive statistics."|Six months|For subjects participating in the PK/PD portion of the study, a calcineurin sample was drawn prior to drug administration in order to assess baseline calcineurin levels. Blood samples were taken at Month 6 for the assessment of pharmacokinetics and pharmacodynamics. Participation by subjects was optional.||% Calcineurin (CNi) compared to baseline||Standard Deviation|Mean
717543|NCT00270634|Secondary|To Demonstrate a 5% Improvement in Renal Function as Measured by Iothalamate Glomerular Filtration Rate (GFR)|ANOVAs to test for differences in GFR at Month 6.|Six months|Standard deviation around Iothalamate GFR made results uninterpretable, therefore Nankivell GFR was reported as it was collected a priori.||mL/min||Standard Deviation|Mean
721689|NCT00321828|Secondary|Local Complications as Assessed by Fistula Formation (Self-draining Enterocutaneous Fistula and Intra-abdominal Abscess Requiring Percutaneous Drainage) Not Requiring Surgery||Time from start of study through year 5||||||
717544|NCT00270634|Primary|Biopsy Proven Acute Rejection (BPAR)|The primary objective of the PROMISE trial was to demonstrate noninferiority of biopsy proven acute rejection (BPAR) rate in de novo renal transplant patients at 6 months in at least one VCS treatment group.|Six months|||percentage of participants|||Number
717545|NCT00270790|Secondary|Response Rates Based on the Study Regimen|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|3 years|21 patients enrolled, however only 16 patients were analyzed due to 5 patients withdrawals.||participants|||Number
717546|NCT00270790|Primary|Participants With Mucositis and Hematological Toxicities With the Addition of Radioprotector Amifostine|Blood work (CMP was collected and evaluated for neutropenia, leukopenia and anemia) is taken prior to chemotherapy administration. The toxicity levels were measured using Common Terminology Criteria for Adverse Events (CTCAE 3.0) and monitored based on the dose of Amifostine given.|3 years|21 patients enrolled, however only 16 patients were analyzed due to 5 patients withdrawals.||participants|||Number
717547|NCT00270842|Secondary|Fall Self Efficacy|Fall Self Efficacy is operationalized as perceived self efficacy (i.e. self confidence) for avoiding a fall during 10 global, relatively non-hazardous activities of daily living (getting dressed and undressed, for example). Fall self efficacy manifests itself with different degrees of fear of falling, each with a unique associated risk level. The MFES is simple, quick, easy-to-administer scale that assesses a patient’s self-reported ability to perform, without falling, each of 14 common activities of daily living in a Likert scale format. Total scale ranges from 0 to 140, the higher score indicated more confidence in ability to manage a fall.|10 weeks|||units on a scale||Standard Deviation|Mean
717548|NCT00270842|Primary|Gait and Balance Measures|The Berg Balance Scale is a commonly used clinical, performance-based measure designed to evaluate performance during various balance activities in community dwelling and institutionalized older adults. The scale consists of 14 common daily balance tasks. Administration requires only minimal basic equipment and takes approximately 15 minutes. All 14 sub-tests are scored on a 5-point ordinal scale based on the subject’s ability to perform the requested task safely and in a timely manner. Sub-test scores are summed to achieve a total score ranging from 0 to 56 with higher scores indicating better performance.|10 weeks|||units on a scale||Standard Deviation|Mean
717549|NCT00270894|Secondary|Overall Survival (OS)|Overall survival is defined as the time from treatment start until death from any cause. The median overall survival time is used to measure OS.|Measured from day 1 of treatment until time of death, assessed up to 48 months.|||Months||95% Confidence Interval|Median
717550|NCT00270894|Secondary|Progression-free Survival (PFS)|PFS is defined as the duration of time from start of treatment to time of progression or death, whichever comes first.|PFS was measured from day 1 of treatment until time of progression or death, whichever comes first, assessed up to 48 months.|||Months||95% Confidence Interval|Median
717551|NCT00270894|Secondary|Left Ventricular Ejection Fraction (LVEF)|LVEF was assessed by echocardiogram (ECHO) or multigated angiogram (MUGA) during neoadjuvant treatment and during follow-up.|At screening, prior to cycle 5, prior to surgery, and then during follow-up at Month 6, 12, 24, and 36|Note that the number of participants analyzed changes with the study interval. At Screening n=30, after Epirubicin/Cyclophosphamide n=30, Pre-surgery n=28, Follow-up Month 6 n=28, Follow-up Month 12 n=20, Follow-up Month 24 n=9, and Follow-up Month 36 n=1.||LVEF percent||Standard Deviation|Mean
717552|NCT00270894|Secondary|Clinical Response Prior to Surgery|Clinical response was assessed via physical exam every 2 weeks during neoadjuvant treatment and via imaging prior to definitive surgery. Clinical complete response was defined as no evidence of cancer in breast by exam or imaging. Clinical partial response was defined as >= 50 % reduction in sum of diameters to measurement of primary lesion compared to pretreatment by exam or imaging. Clinical stable disease was defined as < 50% reduction in sum of diameters to measurement of primary lesion compared to pretreatment by exam or imaging, and < 25% increase in sum of diameters.|Assessed every 2 weeks during neoadjuvant treatment and prior to definitive surgery, up to 23 weeks.|Clinical response assessment was available for 27 patients at the time of surgery.||Participants|||Number
717553|NCT00270894|Secondary|Pathologic Response|Pathologic response was assessed at time of definitive surgery, scheduled to occur 20-24 weeks after study treatment start. Pathologic complete response was defined as no invasive carcinoma in surgical specimen of breast, but residual ductal carcinoma in situ may be present. Pathologic partial response was defined as >= 50% decrease in sum of diameters in pathologic cancer size compared to pretreatment clinical size. Stable disease was defined as < 50% decrease in sum of diameters in pathologic cancer size compared to pretreatment clinical size, and < 25% increase in sum of diameters.|At completion of neoadjuvant treatment period, up to 24 weeks.|28 patients went to surgery, so 28 patients were included in the surgery sample. Note that 4 patients in the pathologic complete response (pCR) group had residual ductal carcinoma in situ (DCIS).||Participants|||Number
717554|NCT00270894|Primary|Frequency of Grade 3 or 4 Hematologic and Nonhematologic Toxicities|Toxicities are evaluated according to the Common Terminology Criteria for Adverse Events, version 3.0. Grade refers to the severity of the adverse event (AE). Generally, grade 1 = mild AE; grade 2 = moderate AE; grade 3 = severe AE; grade 4 = life-threatening or disabling AE; grade 5 = death related to AE.|Toxicities are evaluated every 2 weeks during neoadjuvant treatment and assessed once during the post-treatment follow-up period, up to 25 weeks.|||Events|Participants||Number
717555|NCT00270894|Primary|Percentage of Subjects Able to Complete > 85% of the Planned Dose on Schedule|Feasibility will be determined by evaluating the percentage of subjects able to complete the neoadjuvant portion of the study on time with > 85% of the protocol-specified dose.|From the start of treatment through the neoadjuvant treatment period (approximately 20 weeks)|||percentage of participants|||Number
717556|NCT00270998|Secondary|Satisfaction With Treatment at 12 Months|"Success if participant reported being satisfied on Patient Satisfaction Question (PSQ), a failure if they reported otherwise."|Outcome was measured at 12 months following randomization.|If participant did not attend the 12-month follow-up, missing values were imputed as a failure.||Participants|||Count of Participants
717622|NCT00282087|Secondary|Tolerability/Toxicity of This Regimen|Unacceptable toxicity is defined as grade 3 or 4 non-hematologic toxicity events that are considered to be treatment-related, excluding alopecia and fatigue.|Every 28 days during dosing and then every 3 months thereafter until patient comes off study|||number of major toxicity events|||Number
717557|NCT00270998|Secondary|Satisfaction With Treatment at 3 Months|"Success if participant reported being satisfied on Patient Satisfaction Question (PSQ), a failure if they reported otherwise."|Outcome was measured at three months following randomization.|If participant did not attend the three-month follow-up, missing values were imputed by either the value from the next available follow-up or if the participant was lost to follow-up the participant was treated as a failure.||Participants|||Count of Participants
717558|NCT00270998|Secondary|75% Reduction in Weekly Urinary Incontinence Episodes at 12 Months|Success if participants reported at least 75% reduction in frequency of incontinence episodes on 7-day bladder diary, a failure if they reported otherwise.|Outcome was measured at 12 months following randomization.|If participant did not attend the 12-month follow-up, missing values were imputed as a failure.||Participants|||Count of Participants
717559|NCT00270998|Secondary|75% Reduction in Weekly Urinary Incontinence Episodes at 3 Months|Success if participants reported at least 75% reduction in frequency of incontinence episodes on 7-day bladder diary, a failure if they reported otherwise.|Outcome was measured at three months following randomization.|If participant did not attend the three-month follow-up, missing values were imputed by either the value from the next available follow-up or if the participant was lost to follow-up the participant was treated as a failure.||Participants|||Count of Participants
717560|NCT00270998|Secondary|No Bothersome Stress Incontinence Symptoms at 12 Months.|Success if participants answer either “no” or “yes” with a bother component of “not at all” or “somewhat” to all seven Urogenital Distress Inventory-Stress Incontinence Subscale items of the Pelvic Floor Distress Inventory, or a failure if they responded otherwise.|Outcome was measured at 12 months following randomization.|If participant did not attend the 12-month follow-up, missing values were imputed as a failure.||Participants|||Count of Participants
717561|NCT00270998|Secondary|“Much Better” or “Very Much Better” on PGI-I at 12 Months|PGI-I, Patient Global Impression of Improvement, is a five-point scale that ranges from “not at all” to “very much better.” Participants were considered a success if they responded “much better” or “very much better,” or a failure if they responded otherwise.|Outcome was measured at 12 months following randomization.|If participant did not attend the 12-month follow-up, missing values were imputed as a failure.||Participants|||Count of Participants
717562|NCT00270998|Primary|No Bothersome Stress Incontinence Symptoms at 3 Months|Success if participants answer either “no” or “yes” with a bother component of “not at all” or “somewhat” to all seven Urogenital Distress Inventory-Stress Incontinence Subscale items of the Pelvic Floor Distress Inventory, or a failure if they responded otherwise.|Outcome was measured at three months following randomization.|If participant did not attend the three-month follow-up, missing values were imputed by either the value from the next available follow-up or if the participant was lost to follow-up the participant was treated as a failure.||Participants|||Count of Participants
717563|NCT00270998|Primary|“Much Better” or “Very Much Better” on PGI-I at 3 Months|PGI-I, Patient Global Impression of Improvement, is a five-point scale that ranges from “not at all” to “very much better.” Participants were considered a success if they responded “much better” or “very much better,” or a failure if they responded otherwise.|Outcome was measured at three months following randomization.|If participant did not attend the three-month follow-up, missing values were imputed by either the value from the next available follow-up or if the participant was lost to follow-up the participant was treated as a failure.||Participants|||Count of Participants
717564|NCT00271011|Secondary|Proportion of Patients Experiencing Hematologic and Non-hematologic Adverse Events|The proportion of patients experiencing hematological and non-hematological toxicities will be summarized.|2 months|The study was discontinued and not completed due to the death of a co-investigator and a second co-investigator leaving the institution. Since accrual was not completed the proportion of patients experiencing toxicities could not be statistically determined.|||||
717565|NCT00271011|Primary|Percentage of Patients With an Objective Response|The primary objective of this single-arm phase II study is to determine the response rate (Percentage patients with Complete Response (CR) + Percentage of patients with Partial Response (PR)) for the combination of mitomycin C, irinotecan, and cetuximab in metastatic colorectal cancer with wild type K-Ras. Complete response will be defined as the disappearance of all measurable and evaluable disease for at least 4 weeks without the appearance of new lesions. Partial response will be defined as a decrease in the sum of the longest diameter of target lesions by at least 30% for at least 4 weeks without the appearance of any new lesions.|2 months|The study was discontinued and not completed due to the death of a co-investigator and a second co-investigator leaving the institution.|||||
717566|NCT00271024|Secondary|Opioid Antagonist Reported Side Effects: 4-Weeks Post Quit Date|Participants reporting side effects during the previous week by pill type and sex, 4-weeks following quit date (Study week 7). Participants rated side effects experienced by None, Mild, or Severe.|4-Weeks Post Quit Date (Study Week 7)|All participants who received study treatment by participating through smoking quit date (Study Week 3) were analyzed for this outcome.||Participants|||Number
717567|NCT00271024|Secondary|Opioid Antagonist Reported Side Effects: 1-Week Post Quit Date|Participants reporting side effects during the previous week by pill type and sex, 1-week following quit date (Study week 4). Participants rated side effects experienced by None, Mild, or Severe.|1-Week Post Quit Date (Study Week 4)|All participants who received study treatment by participating through smoking quit date (Study Week 3) were analyzed for this outcome.||Participants|||Number
717568|NCT00271024|Primary|7-Day Point Prevalence Smoking Abstinence: 52 Weeks Post Quit-Date|7-Day Point Prevalence smoking abstinence at 52 weeks post quit date (Study Week 55). 7-Day Point Prevalence abstinence defined as not smoking (even a puff) for seven days in a row or on one day in each of two consecutive weeks during the previous time frame.|52 Weeks Following Smoking Quit Date (Study week 55)|All participants who received study treatment by participating through smoking quit date (Study Week 3)were analyzed for this outcome.||Participants|||Number
717569|NCT00271024|Primary|7-Day Point Prevalence Smoking Abstinence: 26 Weeks Post Quit-Date|7-Day Point Prevalence smoking abstinence at 29 weeks post quit date (Study Week 29). 7-Day Point Prevalence abstinence defined as not smoking (even a puff) for seven days in a row or on one day in each of two consecutive weeks during the previous time frame.|26 Weeks Following Smoking Quit Date (Study week 29)|All participants who received study treatment by participating through smoking quit date (Study Week 3)were analyzed for this outcome.||Participants|||Number
717570|NCT00271024|Primary|7-Day Point Prevalence Smoking Abstinence: 12 Weeks Post Quit-Date|7-Day Point Prevalence smoking abstinence at 12 weeks post quit date (Study Week 15). 7-Day Point Prevalence abstinence defined as not smoking (even a puff) for seven days in a row or on one day in each of two consecutive weeks during the previous time frame.|12 Weeks Following Smoking Quit Date (Study week 15)|All participants who received study treatment by participating through smoking quit date (Study Week 3)were analyzed for this outcome.||Participants|||Number
717571|NCT00271024|Secondary|Weight Change at End of Treatment (Regardless of Quit Status)|Weight change at 12 weeks post quit date (study week 15) for the whole sample regardless of quit status. All data is Mean(SEM) and represents a positive change unless otherwise noted.|Weight change at 12 weeks post quit date (study week 15) from smoking quit date|All participants who received study treatment by participating through smoking quit date (Study Week 3)were analyzed for this outcome, regardless of their abstinence status at 12 weeks post quit date (study week 15)||Pounds||Standard Error|Mean
717572|NCT00271024|Primary|7-Day Point Prevalence Smoking Abstinence: 4 Weeks Post Quit-Date|7-Day Point Prevalence smoking abstinence at 4 weeks post quit date (Study Week 7). 7-Day Point Prevalence abstinence defined as not smoking (even a puff) for seven days in a row or on one day in each of two consecutive weeks during the previous time frame.|4 Weeks Following Smoking Quit Date (Study week 7)|All participants who received study treatment by participating through smoking quit date (Study Week 3)were analyzed for this outcome.||Participants|||Number
717573|NCT00271024|Primary|Prolonged Smoking Abstinence: 12 Weeks Post Quit-Date|Prolonged Abstinence at 12 weeks post quit date (Study Week 15). Prolonged Abstinence defined as not smoking (even a puff of a cigarette) at any point during the previous time frame, allowing for a 1-week grace period.|12 Weeks Following Smoking Quit Date (Study week 15)|All participants who received study treatment by participating through smoking quit date (Study Week 3)were analyzed for this outcome.||Participants|||Number
717574|NCT00271024|Secondary|Weight Change at End of Treatment (Smoking Abstinent Only)|Weight change in lbs at 12 weeks post smoking quit date (study week 15) for only those reporting continued smoking abstinence at the end of treatment. All data are Mean(SEM) and represent positive change, unless otherwise noted. Smoking abstinent for this measure defined as no smoking even 1 puff of a cigarette since the smoking quit date (study week 3), allowing for a 1-week grace period.|Weight change at 12 weeks post smoking quit date (study week 15)|All participants completing through smoking quit date (study week 3) and who were smoking abstinent at end of treatment (study week 15)||Pounds||Standard Error|Mean
717575|NCT00271024|Primary|Prolonged Smoking Abstinence: 4 Weeks Post Quit-Date|Prolonged Abstinence at 4 weeks post quit date (Study Week 7). Prolonged Abstinence defined as not smoking (even a puff of a cigarette) at any point during the previous time frame, allowing for a 1-week grace period.|4 Weeks Following Smoking Quit Date (Study week 7)|All participants who received study treatment by participating through smoking quit date (Study Week 3)were analyzed for this outcome.||Participants|||Number
717576|NCT00271154|Primary|Percentage of Patients Worsened for Clinical Composite Response|Patients considered worsened if they died, were hospitalized with worsening heart failure (HF), crossed over to other arm, demonstrated worsening in New York Heart Association (NYHA) functional class, or reported moderately/markedly worse HF symptoms compared to before CRT implant.|12 Months|All randomized patients were included using Intent to Treat (ITT).||Percentage of participants worsened|||Number
717577|NCT00271154|Secondary|Change in Left Ventricular End Systolic Volume, Indexed (LVESVi)|The change is LVESVi measured at 12 months minus LVESVi measured at baseline. The 12-month echocardiographic measurements were made with CRT programmed off, irespective of the treatment assignment. In CRT ON patients these measurements were recorded after a 10 minute washout period. Two core laboratories performed all echo measurements.|Baseline to 12 months|||milliliters per meters squared||Standard Deviation|Mean
717578|NCT00278473|Secondary|Rosenberg Self-Esteem Inventory|Mean change in Rosenberg Self-Esteem Inventory score at 12 weeks as compared to baseline. The scale is a ten item Likert scale, ranging from 0-30. Scores between 15 and 25 are within normal range; scores below 15 suggest low self-esteem.|baseline and at 12 weeks|||units on a scale||Standard Deviation|Mean
717579|NCT00278473|Secondary|Hamilton Anxiety Rating Scale|Mean Change in Hamilton Anxiety Rating Scale at 12 weeks as compared to baseline. It consists of 14 items, each defined by a series of symptoms. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.|baseline and at 12 weeks|||units on a scale||Standard Deviation|Mean
717580|NCT00278473|Secondary|Beck Depression Inventory|"Mean change in the Beck Depression Inventory Scale at 12 weeks as compared to baseline.
The Beck Depression Inventory, 2nd edition to assess Depression symptoms. BDI-II scores range between 0 and 63, with categorical depression ratings of “minimal” (0–13), “mild” (14–19), “moderate” (20–28), and “severe” (29–63)."|baseline and at 12 weeks|||units on a scale||Standard Deviation|Mean
717581|NCT00278473|Secondary|CAARS-O:L|Change in the Conners Adult ADHD Rating Scales–Observer: Long Version (CAARS-O:L), inattention/memory subscale at 12 weeks as compared to baseline. 12 items subscale. T-score of at least 63 gives risk or possible diagnosis of ADHD. This number, lower or higher, does not indicate severity.|baseline and at 12 weeks|||T-score||Standard Deviation|Mean
717582|NCT00278473|Primary|Time Management, Organization, and Planning Subscale|"Time management, organization, and planning subscale at posttreatment at 12 weeks as compared to baseline.
The mean difference On Time Management Organization and Planning scale which is a 24-item self-report questionnaire that uses a 7-point Likert-type scale ranging from –3 (far below average) to +3 (far above average) and subsequently totaled to obtain a composite index of proficiency (possible scores range from –102 to +102), which was developed and previously used at the ADHD program at the Icahn School of Medicine at Mount Sinai."|baseline and at 12 weeks|||units on a scale||Standard Deviation|Mean
717583|NCT00278473|Primary|Inattention Subscale|Adult Attention Deficit Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Inattention subscale. Mean change score at 12 weeks as compared to baseline. Each item is scored as follows: 0 (none), 1 (mild), 2 (moderate), 3 (severe); the maximum total score with 27 points being the most severe.|12 weeks|||units on a scale||Standard Deviation|Mean
717623|NCT00282087|Primary|Two-year Progression-free Survival Among Women Treated With This Adjuvant Regimen for High Risk Uterine LMS||Every 3 months up to two years|||percentage of participants||95% Confidence Interval|Number
717584|NCT00278525|Primary|Disease Improvement|"Data are reporting number of participants that were classified as disease improvement.
Definition of disease improvement:
Disease improvement defined by at least 25% improvement in skin score (Rodnan), or 10% improvement in pulmonary function tests [diffusing capacity of the lung for carbon monoxide (DLCO), diffusing capacity divided by the alveolar volume (DLCO/VA), or forced vital capacity (FVC)], or in cardiac tests [pulmonary artery (PA) systolic pressure by right heart cath] that persists > 6 months or ability to wean off total parenteral nutrition (TPN)"|12 months|||participants|||Number
717585|NCT00278525|Primary|Time to Treatment Failure|"-Data are reporting number of participants that were classified as treatment failures
Time to Treatment Failure Definition-Treatment failure will not occur until a minimum of 12 months after enrollment at which time failure is defined as:
Failure of skin score (if > 14 on enrollment) to improve or increase in skin score by a 25% above lowest post treatment value and must be documented on 2 occasion 6 months apart
Deterioration in diffusing capacity of the lung for carbon monoxide (DLCO), diffusing capacity divided by the alveolar volume (DLCO/VA) or forced vital capacity (FVC) by 10% below enrollment level or 10% below best post treatment value, due to systemic sclerosis, and documented on 2 occasion 6 months apart
Renal failure due to systemic sclerosis and defined as chronic dialysis for more than 12 months
Gastrointestinal failure due to systemic sclerosis and defined as initiation of total parenteral nutrition(TPN) for more than 12 months"|12 months|All participants were included||participants|||Number
717586|NCT00278655|Secondary|Survival|"Data are reporting the number of participants who survived three years after the transplant
Survival of 21 participants was evaluated at three years after the transplant"|three years|||participants|||Number
717587|NCT00278655|Primary|Disease Progression|Data are reporting number of participants with disease progression. Disease progression is defined as a 1 point increase in the Expanded Disability Status Scale (EDSS) on consecutive evaluations at least 3 months apart.|3 years after transplant|||participants|||Number
717588|NCT00281879|Primary|Number of Participants With Disease Free Survival (DFS).|"Determine the effectiveness of unrelated donor allogeneic hematopoietic stem cells for transplantation after conditioning for the treatment of high-risk hematopoietic malignancies.
Disease-free survival: The length of time after treatment ends that a patient survives without any signs or symptoms of that cancer or any other type of cancer."|Duration of the study; Up to 2 years||||||
717589|NCT00281918|Secondary|Final Analysis: Time to New Treatment for Chronic Lymphocytic Leukemia(CLL)|The time from randomization to the start of a new treatment.|Median observation time was approximately 66.4 months|Participants from the Intent-to-treat population, that included all randomized participants, who started a new CLL treatment.||Days||95% Confidence Interval|Median
717590|NCT00281918|Secondary|Final Analysis: Percentage of Participants With Complete Response (CR) and Partial Response|CR is defined by at least 8 weeks of: 1)Absence of lymphadenopathy 2)No hepatomegaly or splenomegaly 3)Absence of B-symptoms 4)Normal blood count 5)Bone marrow aspirate and biopsy 8 weeks after the clinical and laboratory results demonstrated that a CR was achieved. A marrow sample had to be normocellular for age with less than 30% lymphocytes. Lymphoid nodules had to be absent. If marrow was hypocellular,a repeat biopsy was taken 4 weeks later and samples were re-reviewed in conjunction with the prior pathology. Partial response is defined as a decrease in the size of a tumor, or in the extent of cancer in the body, in response to treatment.|Median observation time was approximately 66.4 months|Intent-to-treat population included all randomized participants.||Percentage of participants||95% Confidence Interval|Number
717591|NCT00281918|Secondary|Final Analysis: Duration of Response|Duration of response was defined as the time from the first documented Complete Response, Partial Response to disease progression or death by any cause.|Median observation time was approximately 66.4 months|Participants from the Intent-to-treat population, all randomized participants, with complete response or partial response who experienced an event (disease progression or death due to any cause).||Days||95% Confidence Interval|Median
717592|NCT00281918|Secondary|Final Analysis: Time to Disease-free Survival (DFS) Event in Participants With Complete Response (CR)|CR is defined by at least 8 weeks of: 1)Absence of lymphadenopathy 2)No hepatomegaly or splenomegaly 3)Absence of B-symptoms 4)Normal blood count 5)Bone marrow aspirate and biopsy 8 weeks after the clinical and laboratory results demonstrated that a CR was achieved. A marrow sample had to be normocellular for age with less than 30% lymphocytes. Lymphoid nodules had to be absent. If marrow was hypocellular,a repeat biopsy was taken 4 weeks later and samples were re-reviewed in conjunction with the prior pathology. DFS was calculated from time of CR to relapse or death|Median observation time was approximately 66.4 months|Participants from the Intent-to-treat population, all randomized participants, with complete response who experienced a disease free survival event (disease relapse or death).||Days||95% Confidence Interval|Median
717593|NCT00281918|Secondary|Final Analysis: Time to Event-free Survival Event|Event-free survival was defined as the time between randomization and the date of disease progression, relapse, start of new Chronic Lymphocytic Leukemia treatment or death by any cause.|Median observation time was approximately 66.4 months|Participants from the Intent-to-treat population, that included all randomized participants, with disease progression, relapse, start of new Chronic Lymphocytic Leukemia treatment or death.||Days||95% Confidence Interval|Median
717594|NCT00281918|Secondary|Final Analysis: Time to Overall Survival Event|Overall survival (OS) was defined as the time between randomization and the date of death due to any cause.|Median observation time was approximately 66.4 months|Participants from the Intent-to-treat population, that included all randomized participants who died.||Days||95% Confidence Interval|Median
717595|NCT00281918|Primary|Final Analysis: Time to Progression-free Survival Event|Progression-free survival was defined as the time between randomization and the date of first documented disease progression, relapse or death by any cause, whichever came first.|Median observation time was approximately 66.4 months|Participants from the Intent-to-treat population, that included all randomized participants, with PFS events.||Days||95% Confidence Interval|Median
717624|NCT00282113|Secondary|Stool Short Chain Butyric Acid Content||4 weeks|||nmoles per mg stool||Standard Deviation|Mean
717625|NCT00282113|Secondary|Stool Colonization With Bifidobacteria|Using standard culture techniques, we measured how many of the first 11 infants in each arm of the study grew bifidobacteria in their feces after four weeks of treatment.|4 weeks|||Participants|||Number
717779|NCT00282672|Secondary|Within the HGD Subgroup, the % of Patients With Complete Histological Clearance of HGD (CR-D) at 12 Months, Comparing Treatment Versus Sham Control Groups.||12 Month|16 HGD Sham procedure subjects crossed over to RFA treatment after one year||percentage of participants|||Number
717596|NCT00281918|Secondary|Disease-free Survival (DFS) of Patients With Confirmed Complete Response (CR).|CR is defined by at least 8 weeks of: 1)Absence of lymphadenopathy 2)No hepatomegaly or splenomegaly 3)Absence of B-symptoms 4)Normal blood count 5)Bone marrow aspirate and biopsy 8 weeks after the clinical and laboratory results demonstrated that a CR was achieved. A marrow sample had to be normocellular for age with less than 30% lymphocytes. Lymphoid nodules had to be absent. If marrow was hypocellular,a repeat biopsy was taken 4 weeks later and samples were re-reviewed in conjunction with the prior pathology. DFS was calculated from time of CR to relapse or death. Median DFS was not reached.|Median observation time at time of analysis was approximately 21 months|The ITT population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not. Informed consent was unavailable at the time of analysis for 2 patients in the FC group and 5 patients in the FCR group. ITT population: FC = 407; FCR = 403.||Days to an event|||Number
717597|NCT00281918|Secondary|Overall Survival (OS)|Overall survival (OS) was defined as the time between randomization and the date of death due to any cause. Median OS was not reached.|Median observation time at time of analysis was approximately 21 months|The ITT population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not. Informed consent was unavailable at the time of analysis for 2 patients in the FC group and 5 patients in the FCR group. ITT population: FC = 407; FCR = 403.||Days|||Number
717598|NCT00281918|Secondary|Event-free Survival (EFS)|Event-free survival (EFS) was defined as the time between randomization and the date of disease progression, relapse, start of new CLL treatment or death by any cause.|Median observation time at time of analysis was approximately 21 months|The ITT population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not. Informed consent was unavailable at the time of analysis for 2 patients in the FC group and 5 patients in the FCR group. ITT population: FC = 407; FCR = 403.||Days||Full Range|Median
717599|NCT00281918|Primary|Progression-free Survival (PFS)|Progression-free survival (PFS) was defined as the time between randomization and the date of first documented disease progression, relapse or death by any cause, whichever came first.|Median observation time at time of analysis was approximately 21 months|The Intent-to-treat (ITT) population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not. Informed consent was unavailable at the time of analysis for 2 patients in the FC group and 5 patients in the FCR group. ITT population: FC = 407; FCR = 403.||Days||Full Range|Median
717600|NCT00281957|Secondary|Toxicity|Number of patients with Grade 3-5 adverse events that are related to study drug by given type of adverse event|Weekly during first cycle, every two weeks during the second cycle, and once a cycle further cycles (one cycle = 4 weeks).|Eligible patients who had received any hydroxyurea||Participants|||Number
717601|NCT00281957|Secondary|One-year Overall Survival||One year after registration|||Percent of population||95% Confidence Interval|Number
717602|NCT00281957|Primary|4-month Progression-free Survival|Progression was defined as one or more of the following: 20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed, unequivocal progression of non-measurable disease, appearance of any new lesions, death due to disease without prior documentation of progression and without symptomatic deterioration.|4 months after registration|||Percent of population||95% Confidence Interval|Number
717603|NCT00281957|Primary|Response Rate (Complete and Partial)|Complete response corresponds to complete disappearance of all measurable and non-measurable lesions with no new lesions. Partial response corresponds to greater than or equal to 30ﬁ decrease of sum of longest diameter of all target measurable lesions with no new lesion and non unequivocal progression of non-measurable disease.|Every 8 weeks until progression|||Percent of participants||95% Confidence Interval|Number
717604|NCT00282048|Other Pre-specified|Relationship of Area Under the Concentration-time Curve at Steady State (AUCss) With Overall Survival (OS)|AUCss is a pharmacokinetic parameter derived from plasma concentration versus time data using non-compartmental or population based analysis methods. OS is time in weeks from the start of study treatment to date of death due to any cause. Relationship of OS versus AUCss was determined as median OS in participants with high AUCss [AUCss >= median AUCss] or low AUCss [AUCss < median AUCss].|Day 1 (Pre-dose), Day 29 and then every 8 weeks until disease progression or discontinuation from study or up to 152 weeks|Participants for whom both PK and OS data were available were included in analysis. 'n' signifies number of participants evaluable for the corresponding category.||weeks||Full Range|Median
717605|NCT00282048|Other Pre-specified|Relationship of Area Under the Concentration-time Curve at Steady State (AUCss) With Progression-free Survival (PFS)|AUCss is a pharmacokinetic parameter derived from plasma concentration versus time data using non-compartmental or population based analysis methods. PFS is median time from first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first. Relationship of PFS versus AUCss was determined as median PFS in participants with high AUCss [AUCss greater than or equal to (>=) median AUCss] or low AUCss [AUCss less than (<) median AUCss].|Day 1 (Pre-dose), Day 29, and then every 8 weeks until disease progression or discontinuation from study or up to 152 weeks|Participants for whom both PK and PFS data were available were included in analysis. 'n' signifies number of participants evaluable for the corresponding category.||weeks||Full Range|Median
717606|NCT00282048|Other Pre-specified|Correlation of Area Under the Concentration-time Curve at Steady State (AUCss) With Confirmed Partial Response (PR)|AUCss: pharmacokinetic parameter derived from plasma concentration versus time data using non-compartmental or population based analysis methods, computed as each participant’s average total daily dose (accounting for dose reductions and any recorded missed doses) divided by population estimated posthoc individual apparent clearance (CL/F), i.e., AUCss = Daily Dose/(CL/F), where F refers to the oral bioavailability, and CL refers to the systemic clearance. PR: responses with at least 30% decrease in sum of longest dimensions of target lesions using baseline (pre-treatment) sum of longest dimensions as reference. Logistic regression with general linear model was applied to data of PR using AUCss; PR was correlated with AUCss as fold increase in odds of PR with increase in AUCss. Fold increase was calculated as exponent of product of logistic regression slope coefficient and unit change of AUCss.|Day 1 (Pre-dose), Day 29 and then every 8 weeks until disease progression or discontinuation from study or up to 152 weeks|Participants for whom both Pharmacokinetic (PK) and PR data were available were included in analysis.||Ratio|||Number
721690|NCT00321828|Secondary|Local Complications as Assessed by Gastrointestinal Bleeding Requiring Transfusion But Not Requiring Surgery||Time from start of study through year 5||||||
717607|NCT00282048|Other Pre-specified|Functional Assessment of Cancer Therapy (FACT)–Kidney Symptom Index (FKSI) Score|FKSI is a questionnaire for FACT–Kidney Symptom Index used to assess QoL/participant-reported outcomes for participants diagnosed with renal cell cancer. The FKSI contained 15 questions each ranging from 0 (not at all) to 4 (very much) so that FKSI ranged between 0-60 where higher scores reflects better functioning and fewer symptoms.|Baseline (Day 1 of Cycle 1), Day 1 of all subsequent cycles up to Cycle 38 and follow up (28 days after last dose)|ITT population included all enrolled participants who received at least 1 dose of the study medication, had a baseline assessment of disease and had the correct histological cancer type. 'n' is the number of participants who completed at least one question.||Units on a Scale||95% Confidence Interval|Mean
717608|NCT00282048|Secondary|Population Pharmacokinetics of Axitinib (AG-013736)|Data for this outcome measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Day 1 (Pre-dose), Day 29, Day 57 and then every 8 weeks until disease progression or discontinuation from study or up to 152 weeks||||||
717609|NCT00282048|Secondary|Functional Assessment of Cancer Therapy (FACT)–Kidney Symptom Index for Disease Cancer Related Symptoms (FKSI-DRS) Score|FKSI-DRS is a subset of FKSI which is a questionnaire for FACT –Kidney Symptom Index used to assess Quality of Life (QoL)/participant-reported outcomes for participants diagnosed with renal cell cancer. The FKSI contained 15 questions and the FKSI-DRS consisted of 9 questions each ranging from 0 (not at all) to 4 (very much) so that FKSI-DRS ranged between 0-36. Since the questions could be reversed coded, as appropriate, before calculating FKSI-DRS, 0 and 36 could be considered the worst and best health states based on the 9 questions comprising FKSI-DRS.|Baseline (Day 1 of Cycle 1), Day 1 of all subsequent cycles up to Cycle 38 and follow up (28 days after last dose)|ITT population included all enrolled participants who received at least 1 dose of the study medication, had a baseline assessment of disease and had the correct histological cancer type. 'n' is the number of participants who completed at least one question.||Units on a Scale||95% Confidence Interval|Mean
717610|NCT00282048|Secondary|Overall Survival (OS)|Time in days from the start of study treatment to date of death due to any cause. OS was calculated as the death date minus the date of first dose of study medication plus 1. Death was determined from AE data (where outcome was death) or from follow-up contact data (where the participant current status was death). For participants who were alive, overall survival was censored at the last contact.|Baseline to death due to any cause or at least 1 year after the first dose for the last participant|ITT population included all enrolled participants who received at least 1 dose of the study medication, had a baseline assessment of disease and had the correct histological cancer type.||Days||95% Confidence Interval|Median
717611|NCT00282048|Secondary|Duration of Response (DR)|Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Baseline to disease progression or discontinuation from study due to any cause, assessed every 8 weeks up to 152 weeks|Subgroup of participants from the ITT population, with a confirmed objective tumor response (CR or PR).||Days||95% Confidence Interval|Median
717612|NCT00282048|Secondary|Progression-free Survival (PFS)|"Time in days from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as first event date minus the date of first dose of study medication plus 1. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Baseline until the date of first documented progression or death due to any cause, assessed every 8 weeks up to 152 weeks|ITT population included all enrolled participants who received at least 1 dose of the study medication, had a baseline assessment of disease and had the correct histological cancer type.||Days||95% Confidence Interval|Median
717613|NCT00282048|Primary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of responses. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum of longest dimensions.|Baseline to disease progression or discontinuation from study due to any cause, assessed every 8 weeks up to 152 weeks|Intent-to-treat (ITT) population included all enrolled participants who received at least 1 dose of the study medication, had a baseline assessment of disease and had the correct histological cancer type.||Percentage of Participants||95% Confidence Interval|Number
717614|NCT00282087|Secondary|Correlation Between Estrogen Receptor (ER) or Progesterone Receptor (PR) Positive and Tumor Response to Treatment (PFS)||2 years|||participants|||Number
717615|NCT00282087|Secondary|Correlation Between 1988 FIGO Stage and Tumor Response to Treatment (PFS)|Stage I: confined to the uterine corpus Stage II: confined to corpus and cervix Stage IIIA: serosa involvement only (disease could involve the uterine serosa, but patients must have had no other evidence of local spread)|2 years|||participants|||Number
717616|NCT00282087|Secondary|Correlation Between Progesterone Receptor (PR) Status and Tumor Response to Treatment (PFS)||2 years|Only 38 of the 47 patients were evaluable||participants|||Number
717617|NCT00282087|Secondary|Correlation Between Estrogen Receptor (ER) Status and Tumor Response to Treatment (PFS)||2 years|Only 38 of the 47 patients were evaluable||participants|||Number
717618|NCT00282087|Secondary|Correlation Between Mitotic Rate and Tumor Response to Treatment (PFS)|Mitotic rate is measured in mitoses per 10 high-power fields|2 years|||mitoses per 10 high-power fields||Full Range|Median
717619|NCT00282087|Secondary|Correlation Between Uterine Serosal Involvement and Tumor Response to Treatment (PFS)|AJCC Stage I: No serosal involvement AJCC Stage II: No serosal involement AJCC Stage III: Serosal only|2 years|||participants|||Number
717620|NCT00282087|Secondary|Correlation Between Menopausal Status at Diagnosis and Tumor Response to Treatment (PFS)||2 years|||participants|||Number
717621|NCT00282087|Secondary|Correlation Between Age and Tumor Response to Treatment (PFS)||2 years|||years||Full Range|Median
717626|NCT00282113|Primary|Weight Gain|Weight at five weeks minus birth weight|5 weeks|Infants left the study as they were discharged from the NICU, therefore many of the infants were not available for measurement at five weeks. The number reported is the number of infants remaining in the study at 5 weeks. Weight in grams is reported.||Grams||Standard Deviation|Mean
717627|NCT00282152|Secondary|Change in Total UPDRS|"The Total Unified Parkinson’s Disease Rating Scale (UPDRS) is a composite scale, consisting of four sections that evaluate mood and behavior, activities of daily living, motor symptoms, and complications of medical therapy.
Range is 0 to 16, with 16 being maximal disability"|baseline to 24 months|||units on a scale||95% Confidence Interval|Mean
717628|NCT00282152|Secondary|Change in UPDRS Part IV, Complications of Therapy|Score: 0-23 0 =no complications, 23 = most complications|baseline to 24 months|||units on a scale||95% Confidence Interval|Mean
717629|NCT00282152|Secondary|Change in UPDRS Part III, Motor Examination, Excluding Rigidity|Score: 0-56 0 = full movement, 56 = most limited|baseline to 24 months|||change in units on a scale||95% Confidence Interval|Mean
717630|NCT00282152|Secondary|Change in UPDRS Part II, Activities of Daily Living|Score: 0-52 0 =normal, 52 = most limited|baseline to 24 months|||units on a scale||95% Confidence Interval|Mean
717631|NCT00282152|Secondary|Change in UPDRS Part I, Mentation Behavior and Mood|Score: 0-16 0 =normal, 16 = most disability|baseline to 24 months|||units on a scale||95% Confidence Interval|Mean
717632|NCT00282152|Primary|Levodopa Equivalents, Change From Baseline|100 mg of levodopa with a dopa-decarboxylase inhibitor = 133 mg of controlled-release levodopa preparations = total levodopa dose + (total levodopa dose x 0.33) of levodopa with dopa-decarboxylase and entacapone = 1 mg of pergolide, pramipexole, or lisuride = 5 mg of ropinirole = 3.3 mg of rotigotine|baseline to 24 months|||mg||95% Confidence Interval|Mean
717633|NCT00282152|Primary|Safety: Time to Reach a 4 Point Increase (Worsening) in Unified Parkinson’s Disease Rating Scale (UPDRS) Motor Score|The primary hypothesis of this feasibility trial was focused on safety and tolerability and that the DBS+ODT group would not worsen more quickly than the ODT group.|baseline to 24 months|all 29 subjects that completed at least one follow up visit were included in the primary analysis following intent to treat principle||months||95% Confidence Interval|Mean
717634|NCT00282243|Secondary|Safety as Assessed by Adverse Events, Laboratory Parameters and Vital Signs|"An adverse event is defined as any reaction, side effect or other untoward medical occurrence, regardless of the relationship to study drug which occurred during the conduct of a clinical study. Clinically significant adverse changes in clinical status, routine laboratory studies or physical examinations were considered adverse events.
A serious adverse event was any adverse event occurring at any dose that resulted in any of the following outcomes:
Death
Life-threatening adverse event
Inpatient hospitalization or prolongation of existing hospitalization
Persistent or significant disability or incapacity
Congenital abnormality or birth defect
Important medical event."|From the first dose of tacrolimus MR formulation through the last dose day plus 10 days (approximately 60 months).|Modified safety analysis set.||participants|||Number
717635|NCT00282243|Secondary|Change From Baseline in Total Bilirubin|Hepatic function was assessed by measuring total bilirubin over the course of the study.|Baseline (the last day of tacrolimus on Day 14 prior to the first conversion to tacrolimus MR), Day 56 (end of the pharmacokinetic phase) and end of treatment (EOT; the last observed value during treatment, maximum time on study was 60 months).|"Modified safety analysis set. N indicates the number of participants with available data at each time point."||mg/dL||Standard Deviation|Mean
717636|NCT00282243|Secondary|Change From Baseline in Aspartate Aminotransferase (AST)|Hepatic function was assessed by measuring aspartate aminotransferase levels over the course of the study.|Baseline (the last day of tacrolimus on Day 14 prior to the first conversion to tacrolimus MR), Day 56 (end of the pharmacokinetic phase) and end of treatment (EOT; the last observed value during treatment, maximum time on study was 60 months).|Modified safety analysis set. “N” indicates the number of participants with available data at each time point.||U/L||Standard Deviation|Mean
717637|NCT00282243|Secondary|Change From Baseline in Alanine Aminotransferase (ALT)|Hepatic function was assessed by measuring alanine aminotransferase levels over the course of the study.|Baseline (the last day of tacrolimus on Day 14 prior to the first conversion to tacrolimus MR), Day 56 (end of the pharmacokinetic phase) and end of treatment (EOT; the last observed value during treatment, maximum time on study was 60 months).|"Modified safety analysis set defined as all patients who took at least 1 dose of tacrolimus and at least one dose of tacrolimus MR during the pharmacokinetic portion of the study. N indicates the number of participants with available data at each time point."||U/L||Standard Deviation|Mean
717638|NCT00282243|Secondary|Primary Reason for Graft Loss|The primary reason for graft loss was recorded by the Investigator. Graft loss was defined as graft failure (re-transplant) or participant death.|From enrollment until the end of study (up to 60 months).|Participants in the modified full analysis set with graft loss.||participants|||Number
717639|NCT00282243|Secondary|Number of Participants With Treatment Failure|Treatment failure was defined as discontinuation of study drug for any reason. Due to discontinuation of the study by the sponsor, treatment failure was not analyzed.|From enrollment until the end of study (up to 60 months).||||||
717640|NCT00282243|Secondary|Number of Participants With Chronic Rejection|Due to the low number of participants with biopsy-confirmed acute rejection episodes, chronic rejection was not analyzed.|From enrollment until the end of study (up to 60 months).||||||
717641|NCT00282243|Secondary|Number of Participants With Clinically Treated Acute Rejection Episodes|A clinically treated acute rejection episode was any biopsy-confirmed or suspected rejection episode that was treated with immunosuppressive therapy.|From enrollment until the end of study (up to 60 months).|Modified full analysis set||participants|||Number
717642|NCT00282243|Secondary|Number of Participants With Multiple Rejection Episodes|This analysis includes rejection episodes that were either confirmed by biopsy by the clinical site pathologist or were clinically treated.|From enrollment until the end of study (up to 60 months).|Modified full analysis set||participants|||Number
717643|NCT00282243|Secondary|Number of Participants Receiving Anti-lymphocyte Antibody Therapy for Acute Rejection|Steroid-resistant rejection episodes were treated with anti-lymphocyte antibodies. If a participant had a histologically proven Banff Grade II or III rejection, they could be initiated on anti-lymphocyte antibody treatment per institutional practice.|From enrollment until the end of study (up to 60 months).|Modified full analysis set||participants|||Number
717644|NCT00282243|Secondary|Grade of Biopsy-confirmed Acute Rejection Episodes|Biopsy-confirmed acute rejection (BCAR) is defined as an episode of acute liver allograft rejection that was confirmed by biopsy results and was Banff grade ≥ I. Biopsies were graded by the clinical site pathologist according to the 1997 Banff criteria for grading of acute liver allograft rejection: Indeterminate: Portal inflammatory infiltrate that fails to meet the criteria for diagnosis of acute rejection; Grade I (Mild): Rejection infiltrate in a minority of the triads that is generally mild and confined within the portal spaces; Grade II (Moderate): Rejection infiltrate, expanding to most or all of the triads; Grade III (Severe): Rejection infiltrate, expanding to most or all of the triads, with spillover into periportal areas and moderate to severe perivenular inflammation that extends into the hepatic parenchyma and is associated with perivenular hepatocyte necrosis. For participants with more than one biopsy-confirmed acute rejection episode, the worst case grade is reported.|From enrollment until the end of study (up to 60 months).|Participants in the modified full analysis set with a biopsy-confirmed acute rejection.||participants|||Number
717645|NCT00282243|Secondary|Time to First Biopsy-confirmed Acute Rejection|For participants with a biopsy-confirmed acute rejection (BCAR), the median number of days from the first dose of study drug to the date of biopsy confirmation. BCAR is defined as an episode of acute liver allograft rejection that was confirmed by biopsy results and was Banff grade ≥ I. Biopsies were graded by the clinical site pathologist according to the 1997 Banff criteria for grading acute liver allograft rejection: Indeterminate: Portal inflammatory infiltrate that fails to meet the criteria for diagnosis of acute rejection; Grade I: Rejection infiltrate in a minority of the triads that is generally mild and confined within the portal spaces; Grade II: Rejection infiltrate, expanding to most or all of the triads; Grade III: Rejection infiltrate, expanding to most or all of the triads, with spillover into periportal areas and moderate to severe perivenular inflammation that extends into the hepatic parenchyma and is associated with perivenular hepatocyte necrosis.|From enrollment until the end of study (up to 60 months).|Participants in the modified full analysis set with a biopsy-confirmed acute rejection.||days||Full Range|Median
717646|NCT00282243|Secondary|Time to Event for Graft Non-survival|For participants with graft loss, the median number of days from the first dose of study drug to graft loss. Graft loss was defined as graft failure (re-transplant) or participant death.|From enrollment until the end of study (up to 60 months).|Participants in the modified full analysis set with graft loss.||days||Full Range|Median
717647|NCT00282243|Secondary|Time to Event for Patient Non-survival|For participants who died on study, the median number of days from first dose of study drug to death due to any cause.|From enrollment until the end of study (up to 60 months).|Participants in the modified full analysis set who died on study.||days||Full Range|Median
717648|NCT00282243|Secondary|Percentage of Participants With Biopsy-confirmed Acute Rejection|Biopsy-confirmed acute rejection (BCAR) is defined as an episode of acute liver allograft rejection that was confirmed by biopsy results and was Banff grade ≥ I. Biopsies were graded by the pathologist at the clinical site according to the 1997 Banff criteria for grading of acute liver allograft rejection: Indeterminate: Portal inflammatory infiltrate that fails to meet the criteria for diagnosis of acute rejection; Grade I (Mild): Rejection infiltrate in a minority of the triads that is generally mild and confined within the portal spaces; Grade II (Moderate): Rejection infiltrate, expanding to most or all of the triads; Grade III (Severe): Rejection infiltrate, expanding to most or all of the triads, with spillover into periportal areas and moderate to severe perivenular inflammation that extends into the hepatic parenchyma and is associated with perivenular hepatocyte necrosis.|From enrollment until the end of study (up to 60 months).|Modified full analysis set||percentage of participants||95% Confidence Interval|Number
717649|NCT00282243|Secondary|Time to Maximum Observed Concentration of Tacrolimus (Tmax)|Time to the first occurrence to reach the maximum concentration of tacrolimus was calculated from whole blood tacrolimus concentrations for both the tacrolimus and tacrolimus MR treatment periods at steady state, without interpolation.|Days 14 and 42 (tacrolimus) and Days 28 and 56 (tacrolimus MR), pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 (pre-dose for tacrolimus only), 12.5, 13, 14, 15, 16, 18, 20, and 24 hours post-dose.|Pharmacokinetic evaluable set||hours||Standard Deviation|Mean
717650|NCT00282243|Primary|Graft Survival|Graft survival was defined as any participant who did not meet the definition of graft loss, where graft loss was defined as graft failure (re-transplant) or participant death.|From enrollment until the end of study (up to 60 months).|Modified full analysis set||percentage of participants||95% Confidence Interval|Number
717651|NCT00282243|Primary|Patient Survival|Patient survival was defined as any participant known to be alive at the time of analysis.|From enrollment until the end of study (up to 60 months).|Modified full analysis set, defined as all patients who took at least one dose of tacrolimus MR during the extended treatment period of the study.||percentage of participants||95% Confidence Interval|Number
717652|NCT00282243|Primary|Minimum Observed Concentration of Tacrolimus (Cmin)|The trough (minimum) concentration of tacrolimus determined from the tacrolimus whole blood concentration value at the 12 hour post-dose concentration based on the evening dose (i.e., the 8 am concentration) for tacrolimus and the 24-hour time point post-dose for tacrolimus MR, prior to receiving the next dose.|Days 14 and 42 at 12 hours post-dose (tacrolimus) and Days 28 and 56 at 24 hours post-dose (for tacrolimus MR).|Pharmacokinetic evaluable set||ng/mL||Standard Deviation|Mean
717653|NCT00282243|Secondary|Maximum Observed Concentration of Tacrolimus (Cmax)|The maximum concentration was calculated from whole blood tacrolimus concentrations for both the tacrolimus and tacrolimus MR treatment periods at steady state, without interpolation.|Days 14 and 42 (tacrolimus) and Days 28 and 56 (tacrolimus MR), pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 (pre-dose for tacrolimus only), 12.5, 13, 14, 15, 16, 18, 20, and 24 hours post-dose.|Pharmacokinetic evaluable set||ng/mL||Standard Deviation|Mean
717654|NCT00282243|Primary|Area Under the Concentration-time Curve From Time 0 to 24 Hours (AUC0-24) for Tacrolimus|The area under the concentration-time curve was calculated from whole blood tacrolimus concentrations for both the tacrolimus and tacrolimus MR treatment periods at steady state using the linear trapezoidal rule. The AUC0-24 for tacrolimus was calculated as the sum of the AUC0-12 for the morning (0-12 hour) and afternoon (12-24 hour) doses.|Days 14 and 42 (tacrolimus) and Days 28 and 56 (tacrolimus MR), pre-dose 0.5, 1, 2, 3, 4, 6, 8, 12 (pre-dose for tacrolimus only), 12.5, 13, 14, 15, 16, 18, 20, and 24 hours post-dose.|Pharmacokinetic evaluable set defined as all patients with four complete pharmacokinetic profiles (two tacrolimus and 2 tacrolimus MR).||ng*hr/mL||Standard Deviation|Mean
717655|NCT00282256|Secondary|Safety as Assessed by Clinical Signs and Symptoms, Laboratory Parameters and Diagnostic Tests|"An adverse event (AE) is defined as any reaction, side effect or other untoward medical occurrence, regardless of the relationship to study drug which occurred during the conduct of a clinical study. Clinically significant adverse changes in clinical status, routine laboratory studies or physical examinations were considered adverse events.
A serious adverse event was any adverse event occurring at any dose that resulted in any of the following outcomes:
Death
Life-threatening adverse event
Inpatient hospitalization or prolongation of existing hospitalization
Persistent or significant disability or incapacity
Congenital abnormality or birth defect
Important medical event."|From the first dose of tacrolimus MR formulation through the last dose day plus 10 days (approximately 54 months).|Modified safety analysis set defined as all participants who took at least 1 dose of both tacrolimus and tacrolimus MR formulation during the pharmacokinetic period of the study.||participants|||Number
717656|NCT00282256|Secondary|Primary Reason for Graft Loss|The primary reason for graft loss was recorded by the Investigator. Graft loss was defined as graft failure (re-transplant) or participant death.|From enrollment until the end of study (up to 54 months).|Participants in the modified full analysis set with graft loss.||participants|||Number
717657|NCT00282256|Secondary|Number of Participants With Treatment Failure|Treatment failure was defined as discontinuation of study drug for any reason. Due to discontinuation of the study by the sponsor, treatment failure was not analyzed.|From enrollment until the end of study (up to 54 months).||||||
717658|NCT00282256|Secondary|Number of Participants With Chronic Rejection|Due to the low number of participants with biopsy-confirmed acute rejection episodes, chronic rejection was not analyzed.|From enrollment until the end of study (up to 54 months).||||||
717659|NCT00282256|Secondary|Number of Participants With Clinically Treated Acute Rejection Episodes|A clinically treated acute rejection episode was any biopsy-confirmed or suspected rejection episode that was treated with immunosuppressive therapy.|From enrollment until the end of study (up to 54 months).|Modified full analysis set.||participants|||Number
717660|NCT00282256|Secondary|Number of Participants With Multiple Rejection Episodes|This analysis includes rejection episodes that were either confirmed by biopsy by the clinical site pathologist or were clinically treated.|From enrollment until the end of study (up to 54 months).|Modified full analysis set.||participants|||Number
717661|NCT00282256|Secondary|Number of Participants Receiving Anti-lymphocyte Antibody Therapy for Acute Rejection|Steroid-resistant rejection episodes were treated with anti-lymphocyte antibodies. If a participant had a histologically proven Banff Grade II or III rejection, they could be initiated on anti-lymphocyte antibody treatment per institutional practice.|From enrollment until the end of study (up to 54 months).|Modified full analysis set.||participants|||Number
717662|NCT00282256|Secondary|Grade of Biopsy-confirmed Acute Rejection Episodes|Biopsy-confirmed acute rejection (BCAR) is defined as an episode of acute liver allograft rejection that was confirmed by biopsy results and was Banff grade ≥ I. Biopsies were graded by the clinical site pathologist according to the 1997 Banff criteria for grading of acute liver allograft rejection: Indeterminate: Portal inflammatory infiltrate that fails to meet the criteria for diagnosis of acute rejection; Grade I (Mild): Rejection infiltrate in a minority of the triads that is generally mild and confined within the portal spaces; Grade II (Moderate): Rejection infiltrate, expanding to most or all of the triads; Grade III (Severe): Rejection infiltrate, expanding to most or all of the triads, with spillover into periportal areas and moderate to severe perivenular inflammation that extends into the hepatic parenchyma and is associated with perivenular hepatocyte necrosis. For participants with more than one biopsy-confirmed acute rejection episode, the worst case grade is reported.|From enrollment until the end of study (up to 54 months).|Participants in the modified full analysis set with a biopsy-confirmed acute rejection.||participants|||Number
717663|NCT00282256|Secondary|Time to First Biopsy-confirmed Acute Rejection|For participants with a biopsy-confirmed acute rejection (BCAR), the median number of days from the first dose of study drug to the date of biopsy confirmation. BCAR is defined as an episode of acute liver allograft rejection that was confirmed by biopsy results and was Banff grade ≥ I. Biopsies were graded by the clinical site pathologist according to the 1997 Banff criteria for grading acute liver allograft rejection: Indeterminate: Portal inflammatory infiltrate that fails to meet the criteria for diagnosis of acute rejection; Grade I: Rejection infiltrate in a minority of the triads that is generally mild and confined within the portal spaces; Grade II: Rejection infiltrate, expanding to most or all of the triads; Grade III: Rejection infiltrate, expanding to most or all of the triads, with spillover into periportal areas and moderate to severe perivenular inflammation that extends into the hepatic parenchyma and is associated with perivenular hepatocyte necrosis.|From enrollment until the end of study (up to 54 months).|Participants in the modified full analysis set with a biopsy-confirmed acute rejection.||days||Full Range|Median
717664|NCT00282256|Secondary|Time to Event for Graft Non-survival|For participants with graft loss, the median number of days from the first dose of study drug to graft loss. Graft loss was defined as graft failure (re-transplant) or participant death.|From enrollment until the end of study (up to 54 months).|Participants in the modified full analysis set with graft loss.||days||Full Range|Median
717665|NCT00282256|Secondary|Time to Event for Patient Non-survival|For participants who died on study, the median number of days from first dose of study drug to death due to any cause.|From enrollment until the end of study (up to 54 months).|Participants in the modified full analysis set who died on study.||days||Full Range|Median
717666|NCT00282256|Secondary|Percentage of Participants With Biopsy-confirmed Acute Rejection|Biopsy-confirmed acute rejection (BCAR) is defined as an episode of acute liver allograft rejection that was confirmed by biopsy results and was Banff grade ≥ I. Biopsies were graded by the pathologist at the clinical site according to the 1997 Banff criteria for grading of acute liver allograft rejection: Indeterminate: Portal inflammatory infiltrate that fails to meet the criteria for diagnosis of acute rejection; Grade I (Mild): Rejection infiltrate in a minority of the triads that is generally mild and confined within the portal spaces; Grade II (Moderate): Rejection infiltrate, expanding to most or all of the triads; Grade III (Severe): Rejection infiltrate, expanding to most or all of the triads, with spillover into periportal areas and moderate to severe perivenular inflammation that extends into the hepatic parenchyma and is associated with perivenular hepatocyte. necrosis|From enrollment until the end of study (up to 54 months).|Modified full analysis set.||percentage of participants|||Number
717667|NCT00282256|Secondary|Time to Maximum Observed Concentration of Tacrolimus (Tmax)|Time to reach the first observed maximum concentration of tacrolimus was calculated from whole blood tacrolimus concentrations for both tacrolimus and tacrolimus MR at steady state, without interpolation.|For tacrolimus, Day 7 at 0 (pre-dose), 0.5, 1, 2, 3, 6, 8, 12 (pre-dose), 13, 14, 15, 18, 20, and 24 hours. For tacrolimus MR, Day 14 at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 18, 20, and 24 hours post-dose.|Pharmacokinetic evaluable set.||hours||Full Range|Median
717668|NCT00282256|Primary|Graft Survival|Graft survival was defined as any participant who did not meet the definition of graft loss, where graft loss was defined as graft failure (re-transplant) or participant death.|From enrollment until the end of study (up to 54 months).|Modified full analysis set.||percentage of participants||95% Confidence Interval|Number
717669|NCT00282256|Primary|Patient Survival|Patient survival was defined as any participant known to be alive at the end of the study.|From enrollment until the end of study (up to 54 months).|The Modified Full Analysis Set included all patients who took at least 1 dose of tacrolimus MR formulation during the extended treatment period.||percentage of participants||95% Confidence Interval|Number
717670|NCT00282256|Primary|Minimum Observed Concentration of Tacrolimus (Cmin)|The trough (minimum) concentration of tacrolimus determined from the tacrolimus whole blood concentration value at the 12 hour post-dose concentration based on the evening dose (i.e., the 8 am concentration) for tacrolimus and the 24-hour time point post-dose for tacrolimus MR, prior to receiving the next dose.|Day 7 at 12 hours post-dose (tacrolimus) and Day 14 at 24 hours post-dose (tacrolimus MR).|Pharmacokinetic evaluable set.||ng/mL||Standard Deviation|Mean
717671|NCT00282256|Secondary|Maximum Observed Concentration of Tacrolimus (Cmax)|The maximum concentration was calculated from whole blood tacrolimus concentrations for both the tacrolimus and tacrolimus MR at steady state, without interpolation.|For tacrolimus, Day 7 at 0 (pre-dose), 0.5, 1, 2, 3, 6, 8, 12 (pre-dose), 13, 14, 15, 18, 20, and 24 hours. For tacrolimus MR, Day 14 at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 18, 20, and 24 hours post-dose.|Pharmacokinetic evaluable set.||ng/mL||Standard Deviation|Mean
717672|NCT00282256|Primary|Area Under the Concentration-time Curve From Time 0 to 24 Hours (AUC0-24) for Tacrolimus|The area under the concentration-time curve was calculated from whole blood tacrolimus concentrations for both tacrolimus and tacrolimus MR at steady state using the linear trapezoidal rule. The AUC0-24 for tacrolimus was calculated as the sum of the AUC0-12 and AUC 12-24 for the morning and afternoon doses.|For tacrolimus, Day 7 at 0 (pre-dose), 0.5, 1, 2, 3, 6, 8, 12 (pre-dose), 13, 14, 15, 18, 20, and 24 hours. For tacrolimus MR, Day 14 at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 18, 20, and 24 hours post-dose.|The pharmacokinetic evaluable set was defined as all patients who completed both pharmacokinetic profiles: one for tacrolimus, and one for tacrolimus MR. A complete pharmacokinetic profile was considered to be a profile that was adequate to determine AUC0-24, Cmax, and Cmin.||ng*hr/mL||Standard Deviation|Mean
717673|NCT00282282|Secondary|Disease Response.|Disease response was assessed as 2 year progression-free survival. The median follow-up time was 1.84 years. The percentage of participants with who reached this timepoint with no disease progression are reported.|2 years|||percentage of participants||95% Confidence Interval|Number
717674|NCT00282282|Secondary|Percentage of Participants With ≥90 Percent Donor-derived Hematopoeisis Around 100 Days Post Transplantation|The percentage of participants with ≥90 percent donor-derived hematopoeisis was assessed around day +100 using peripheral blood chimerism.|100 days|||percentage of participants|||Number
717675|NCT00282282|Primary|Incidence of Grade II-IV Acute GVHD (aGVHD) Developing by Day 100 Following Non-myeloablative PBSC Transplantation Using Tacrolimus and Sirolimus.|All participants received tacrolimus and sirolimus in this one arm study. There were no participants considered unevaluable for this measure (deceased prior to day 100). The total number of people who developed grade II-IV aGVHD before day 100 are reported here.|100 days|Participants who lived more than 30 days posttransplant were considered evaluable. Incidence of grade II-IV aGVHD was adjusted for participants who had aGVHD off-treatment.||participants|||Number
717676|NCT00282295|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Throughout the entire study period (Day 0 - Month 2)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.||Subjects|||Number
717677|NCT00282295|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE =An AE which prevented normal, everyday activities. Such an AE, for example, prevented attendance at work/school and necessitated the administration of corrective therapy. Related = AE assessed by the investigator as related to the vaccination.|Within the 31-day (Days 0-30) period after each vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.||Subjects|||Number
717678|NCT00282295|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, fever [defined as oral temperature equal to or above 37.5 degrees Celsius (°C)], headache and gastrointestinal symptoms [gastro sympt]. Any = any solicited general symptom irrespective of intensity grade or relationship to vaccination. Grade 3 = symptoms that prevented normal activities. Grade 3 Fever = temperature higher than (>) 39° C. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Gastrointestinal symptoms included nausea, vomiting, diarrhea and/or abdominal pain.|Within 4-days (Days 0-3) after each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet completed.||Subjects|||Number
717728|NCT00282464|Secondary|Change in Global Clinical Severity of Symptoms (CGI-S)|Change is observed value at each visit minus baseline value. CGI-S is an instrument to measure severity of mental illness. Scale range: 0 = not assessed, 1 = normal, 7 = among most extremely ill|Baseline to week 6|"Week 1 - Week 6 is Intent to treat (ITT) population Observed Cases.
Overall is Average of Weeks 1 – 6."||score on scale||Standard Error|Least Squares Mean
717679|NCT00282295|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = any solicited local symptom irrespective of intensity grade. Grade 3 pain = pain that prevented normal activities. Grade 3 redness/swelling = redness/swelling with diameter ≥ 50 millimeters (mm).|Within 4-days (Day 0-3) after each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet completed.||Subjects|||Number
717680|NCT00282295|Secondary|Number of Subjects With Vaccine Responses for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 Antibodies|Vaccine responses for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 antibodies were defined as: for initially seronegative subjects (pre-vaccination concentration below the cut-off titer of 8): antibody titers at least four times the cut-off (post-vaccination concentration ≥ 32) one month after vaccination with Menactra™ the vaccine, and for initially seropositive subjects (pre-vaccination titer ≥ 8): antibody titers at least four times the pre-vaccination antibody titers, one month after vaccination with the Menactra™ vaccine.|At Month 1 (one month after vaccination with Menactra™ vaccine)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available & randomization code not broken who had received at least 1 dose of study vaccine (known administration site) & had not received a vaccine not specified or forbidden by the protocol.||Subjects|||Number
717681|NCT00282295|Secondary|Titers for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 Antibodies|Antibody titers are presented as geometric mean titers (GMTs).|At Day 0 (PRE) and at Month 1 (M1) post Menactra™ vaccination|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available & randomization code not broken who had received at least 1 dose of study vaccine (known administration site) & had not received a vaccine not specified or forbidden by the protocol.||Titers||95% Confidence Interval|Geometric Mean
717682|NCT00282295|Secondary|Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL).|At Month 1 (post Boostrix® vaccination)|The analysis was performed on the According-To-Protocol cohort for immunogenicity,which included all evaluable subjects with immunogenicity data available & randomization code not broken who had received at least 1 dose of study vaccine (known administration site) & had not received a vaccine not specified or forbidden by the protocol||EL.U/mL||95% Confidence Interval|Geometric Mean
717683|NCT00282295|Secondary|Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL).|At Day 0 before (PRE) Boostrix® vaccination|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available & randomization code not broken who had received at least 1 dose of study vaccine (known administration site) & had not received a vaccine not specified or forbidden by the protocol.||EL.U/mL||95% Confidence Interval|Geometric Mean
717684|NCT00282295|Secondary|Number of Subjects With Booster Responses for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies|Booster responses for anti-PT, anti-FHA and anti-PRN antibodies were defined as: for initially seronegative subjects (pre-vaccination concentration below the cut-off concentration of 5 EL.U/mL): antibody concentrations at least four times the cut-off (postvaccination concentration ≥20 EL.U/mL) one month after vaccination with the Boostrix® vaccine; for initially seropositive subjects with pre-vaccination concentration ≥5 EL.U/mL and < 20 EL.U/mL: an increase in antibody concentrations of at least four times the pre-vaccination concentration, one month after vaccination with the Boostrix® vaccine; and for initially seropositive subjects with pre-vaccination concentration ≥ 20 EL.U/mL: an increase in antibody concentrations of at least two times the pre-vaccination concentration one month after vaccination with the Boostrix® vaccine.|At Month1 (post Boostrix® vaccination)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available & randomization code not broken who had received at least 1 dose of study vaccine (known administration site) & had not received a vaccine not specified or forbidden by the protocol.||Subjects|||Number
717685|NCT00282295|Secondary|Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).|At Month 1 (M1) post Menactra™ vaccination|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available & randomization code not broken who had received at least 1 dose of study vaccine (known administration site) & had not received a vaccine not specified or forbidden by the protocol.||IU/mL||95% Confidence Interval|Geometric Mean
717686|NCT00282295|Secondary|Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).|At Day 0 (PRE) and at Month 1 (M1) post Boostrix® vaccination|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available & randomization code not broken who had received at least 1 dose of study vaccine (known administration site) & had not received a vaccine not specified or forbidden by the protocol.||IU/mL||95% Confidence Interval|Geometric Mean
717687|NCT00282295|Secondary|Number of Subjects With Booster Responses for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies|"Booster responses for anti-D and anti-T antibodies were defined as:
for initially seronegative subjects (pre-vaccination concentration below the cut-off concentration of 0.1 IU/mL): antibody concentrations at least four times the cut-off (postvaccination concentration ≥ 0.4 IU/mL), one month after vaccination with the Boostrix® vaccine; and for initially seropositive subjects (pre-vaccination concentration ≥ 0.1 IU/mL): an increase in antibody concentrations of at least four times the pre-vaccination concentration one month after vaccination with the Boostrix® vaccine."|At Month 1 (post Boostrix® vaccination)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available & randomization code not broken who had received at least 1 dose of study vaccine (known administration site) & had not received a vaccine not specified or forbidden by the protocol.||Subjects|||Number
717688|NCT00282295|Secondary|Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens|Cut-off values assessed were greater than or equal to 0.1 international units per milliliter (IU/m L).|At Day 0 (PRE) and at Month 1 (M1) post Boostrix® vaccination|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available & randomization code not broken who had received at least 1 dose of study vaccine (known administration site) & had not received a vaccine not specified or forbidden by the protocol.||Subjects|||Number
717689|NCT00282295|Secondary|Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies|Cut-off values assessed were greater than or equal to 1.0 international units per milliliter (IU/mL).|At Month 1 (post Boostrix® vaccination)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available & randomization code not broken who had received at least 1 dose of study vaccine (known administration site) & had not received a vaccine not specified or forbidden by the protocol.||Subjects|||Number
717690|NCT00282295|Secondary|Number of Subjects With Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibodies|Cut-off values assessed were greater than or equal to 1.0 international units per milliliter (IU/mL).|At Day 0 (PRE) before Boostrix® vaccination|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available & randomization code not broken who had received at least 1 dose of study vaccine (known administration site) & had not received a vaccine not specified or forbidden by the protocol.||Subjects|||Number
717691|NCT00282295|Primary|Number of Subjects With Vaccine Responses for Serum Bactericidal Assay Against Neisseria Meningitidis Serogroups A (rSBA-MenA), C (rSBA-MenC), Y (rSBA-MenY) and W-135 (rSBA-MenW-135)|Vaccine responses for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 antibodies were defined as: for initially seronegative subjects (pre-vaccination concentration below the cut-off titer of 8): antibody titers at least four times the cut-off (post-vaccination concentration ≥ 32) one month after vaccination with Menactra™ vaccination; and for initially seropositive subjects (pre-vaccination titer ≥ 8): antibody titers at least four times the pre-vaccination antibody titers, one month after vaccination with Menactra™ vaccine.|At Month 1 (post Boostrix® vaccination)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available & randomization code not broken who had received at least 1 dose of study vaccine (known administration site) & had not received a vaccine not specified or forbidden by the protocol.||Subjects|||Number
717692|NCT00282295|Primary|Number of Subjects With Booster Responses for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies|"Booster responses for anti-PT, anti-FHA and anti-PRN antibodies were defined as:
for initially seronegative subjects (pre-vaccination concentration below the cut-off concentration of 5 EL.U/mL): antibody concentrations at least four times the cut-off (postvaccination concentration ≥ 20 EL.U/mL) one month after vaccination with the Boostrix® vaccine; for initially seropositive subjects with pre-vaccination concentration ≥5 EL.U/mL and < 20 EL.U/mL: an increase in antibody concentrations of at least four times the pre-vaccination concentration, one month after vaccination with the Boostrix® vaccine; and for initially seropositive subjects with pre-vaccination concentration ≥ 20 EL.U/mL: an increase in antibody concentrations of at least two times the pre-vaccination concentration one month after vaccination with the Boostrix® vaccine."|At Month 1 (post Boostrix® vaccination)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available & randomization code not broken who had received at least 1 dose of study vaccine (known administration site) & had not received a vaccine not specified or forbidden by the protocol.||Subjects|||Number
717693|NCT00282295|Primary|Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations|Concentrations were presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).|At Month 1 (post Boostrix® vaccination)|The analysis was performed on the According-To-Protocol cohort for immunogenicity,which included all evaluable subjects with immunogenicity data available & randomization code not broken who had received at least 1 dose of study vaccine (known administration site) & had not received a vaccine not specified or forbidden by the protocol||EL.U/mL||95% Confidence Interval|Geometric Mean
717694|NCT00282295|Primary|Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies|Cut-off values assessed were greater than or equal to 1.0 international units per milliliter (IU/mL).|At Month 1 (post Boostrix® vaccination)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available and (&) randomization code not broken who had received at least 1 dose of study vaccine (known administration site) & had not received a vaccine not specified or forbidden by the protocol.||Subjects|||Number
717695|NCT00282308|Secondary|Percentage of Patients in Group A With an Improvement of at Least 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20/50/70) From Baseline at Week 24|Improvement must be seen in tender and swollen joint counts (28 assessed joints) and in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, the extreme left end of the line “no disease activity” [symptom-free and no arthritis symptoms] and the extreme right end “maximum disease activity”; patient assessment of pain in previous the 24 hours on a VAS (extreme left end of the line “no pain” and the extreme right end “unbearable pain”); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and C reactive protein or, if missing, erythrocyte sedimentation rate.|Week 24|Safety population: All patients who received any amount of rituximab or any vaccine. Since only limited efficacy data were collected in this study, the parameters necessary to calculate the ACR20/50/70 responses were only available for patients in Group A.||Percentage of patients|||Number
717729|NCT00282464|Secondary|Change in Total Score of Young Mania Rating Scale (YMRS)|Change is observed value at each visit minus baseline value. YMRS: 11 item instrument with scale range 0 to 4 for 7 items and 0 to 8 for 4 items. 0=normal; 4 or 8=most abnormal. Total possible score is 0 - 60. Overall is average response Week 1 - 6.|Baseline to week 6|"Week 1 - Week 6 is Intent to treat (ITT) population Observed Cases.
Overall is Average of Weeks 1 – 6."||score on scale||Standard Error|Least Squares Mean
717696|NCT00282308|Secondary|Percentage of Patients Who Maintained a Positive Response to the C. Albicans Skin Test From Day 1 to Week 24 for Group A or From Day 1 to Week 12 for Group B|Patients received an intradermal injection of C. albicans on the volar surface of the forearm on Day 1 and Week 24 for Group A or on Day 1 and Week 12 for Group B. Forty-eight to 72 hours after injection, patients were evaluated for a delayed-type hypersensitivity response by measuring the diameter of induration (palpable raised, hardened area of the forearm skin). A positive response to the C. albicans skin test was defined as at least 5 mm in diameter of induration.|Day 1 to Week 24 for Group A and Day 1 to Week 12 for Group B|Skin test per-protocol population: Group A – All patients randomized to Group A who received any rituximab infusion, had Day 1 and Week 24 skin tests, and who provided complete diameter of induration readings. Group B – All patients randomized to Group B who had Day 1 and Week 12 skin tests and who provided complete diameter of induration readings.||Percentage of patients|||Number
717697|NCT00282308|Secondary|Serum Level of Anti-keyhole Limpet Hemocyanin Antibody Measured Immediately Prior to and 4 Weeks After the First Administration of Keyhole Limpet Hemocyanin|Anti-keyhole limpet hemocyanin antibody was measured immediately prior to and 4 weeks after the first administration of keyhole limpet hemocyanin. The keyhole limpet hemocyanin antibody ELISA assay used keyhole limpet hemocyanin as the plate coat and anti-human IgG-horseradish peroxidase for detection.|Week 32 to Week 36 for Group A and Week 8 to Week 12 for Group B|Immune response per-protocol population: Group A – All patients randomized to Group A who received any rituximab infusion and any vaccine and had pre-vaccination and 4-week post-vaccination blood samples. Group B – All patients randomized to Group B who received any vaccine and had pre-vaccination and 4-week post-vaccination blood samples.||IU/mL||95% Confidence Interval|Geometric Mean
717698|NCT00282308|Secondary|Serum Level of Anti-pneumococcal Antibody Measured Immediately Prior to and 4 Weeks After Administration of a 23-valent Pneumococcal Polysaccharide Vaccine|Anti-pneumococcal antibody was measured immediately prior to and 4 weeks after administration of a 23-valent pneumococcal polysaccharide vaccine. The pneumococcal antibody assay was a fluoroimmunoassay that used a Luminex Multiplex platform. Purified capsular polysaccharides isolated from 12 serotypes of S. pneumonia were covalently attached to microbeads and used as a capturing reagent. Phycoerythrin conjugated anti-human IgG was used for detection.|Week 28 to Week 32 for Group A and Week 4 to Week 8 for Group B|Immune response per-protocol population: Group A – All patients randomized to Group A who received any rituximab infusion and any vaccine and had pre-vaccination and 4-week post-vaccination blood samples. Group B – All patients randomized to Group B who received any vaccine and had pre-vaccination and 4-week post-vaccination blood samples.||µg/mL||95% Confidence Interval|Geometric Mean
717699|NCT00282308|Secondary|Serum Level of Anti-tetanus Antibody Measured Immediately Prior to and 4 Weeks After Administration of a Tetanus Toxoid Adsorbed Booster Vaccine|Anti-tetanus antibody was measured in serum samples immediately prior to and 4 weeks after administration of a tetanus toxoid adsorbed booster vaccine. The tetanus antibody test was an ELISA that used tetanus toxoid as a capturing reagent and alkaline phosphatase-conjugated anti-human IgG (γ) for detection.|Week 24 to Week 28 for Group A and Day 1 to Week 4 for Group B|Immune response per-protocol population: Group A – All patients randomized to Group A who received any rituximab infusion and any vaccine and had pre-vaccination and 4-week post-vaccination blood samples. Group B – All patients randomized to Group B who received any vaccine and had pre-vaccination and 4-week post-vaccination blood samples.||IU/mL||95% Confidence Interval|Geometric Mean
717700|NCT00282308|Secondary|Percentage of Patients With a Positive Immune Response to at Least k (for k = 1, 2, 3, 4, 5) of the 12 Anti-pneumococcal Antibody Serotypes in Response to the 23-valent Pneumococcal Polysaccharide Vaccine|The immune response to each of the 12 anti-pneumococcal antibody serotypes was measured in serum samples immediately prior to and 4 weeks after vaccine administration. The pneumococcal antibody assay was a fluoroimmunoassay that used a Luminex Multiplex platform. Purified capsular polysaccharides isolated from 12 serotypes of S. pneumonia were covalently attached to microbeads and used as a capturing reagent. Phycoerythrin conjugated anti-human IgG was used for detection. A positive immune response against a serotype was defined as a 2-fold increase or an increase of > 1 μg/mL from pre-vaccination levels.|Week 28 to Week 32 for Group A and Week 4 to Week 8 for Group B|Immune response per-protocol population: Group A – All patients randomized to Group A who received any rituximab infusion and any vaccine and had pre-vaccination and 4-week post-vaccination blood samples. Group B – All patients randomized to Group B who received any vaccine and had pre-vaccination and 4-week post-vaccination blood samples.||Percentage of patients|||Number
717701|NCT00282308|Secondary|Percentage of Patients With a Positive Immune Response to at Least 50% (≥ 6 of 12) of the 12 Anti-pneumococcal Antibody Serotypes in Response to the 23-valent Pneumococcal Polysaccharide Vaccine|The immune response to each of the 12 anti-pneumococcal antibody serotypes was measured in serum samples immediately prior to and 4 weeks after vaccine administration. The pneumococcal antibody assay was a fluoroimmunoassay that used a Luminex Multiplex platform. Purified capsular polysaccharides isolated from 12 serotypes of S. pneumonia were covalently attached to microbeads and used as a capturing reagent. Phycoerythrin conjugated anti-human IgG was used for detection. A positive immune response against a serotype was defined as a 2-fold increase or an increase of > 1 μg/mL from pre-vaccination levels.|Week 28 to Week 32 for Group A and Week 4 to Week 8 for Group B|Immune response per-protocol population: Group A – All patients randomized to Group A who received any rituximab infusion and any vaccine and had pre-vaccination and 4-week post-vaccination blood samples. Group B – All patients randomized to Group B who received any vaccine and had pre-vaccination and 4-week post-vaccination blood samples.||Percentage of patients|||Number
717713|NCT00282347|Secondary|Percentage of Participants Who Achieved a Complete Renal Response at Week 52|A participant had a complete renal response if they met the following 3 criteria: (1) Normalization of serum creatinine as evidenced by a serum creatinine level ≤ the upper limit of the normal range of central laboratory values or a serum creatinine level ≤ 15% greater than Baseline, if Baseline serum creatinine was within the normal range of the central laboratory values; (2) Inactive urinary sediment (as evidenced by < 5 red blood cells/high-power field and absence of red cell casts; (3) Urinary protein to creatinine ratio < 0.5.|Week 52|Intent-to-treat population: All randomized participants who received any amount of study drug (rituximab or placebo).||Percentage of participants|||Number
717780|NCT00282672|Secondary|The % of Patients With Complete Histological Clearance of IM at 12 Months, Comparing Treatment Versus Sham Control Groups Within a Specific Dysplasia Subgroup||12 months|||percentage of participants|||Number
717702|NCT00282308|Secondary|Percentage of Patients With a Positive Immune Response to Each of the 12 Anti-pneumococcal Antibody Serotypes in Response to the 23-valent Pneumococcal Polysaccharide Vaccine|The immune response to each of the 12 anti-pneumococcal antibody serotypes was measured in serum samples immediately prior to and 4 weeks after vaccine administration. The pneumococcal antibody assay was a fluoroimmunoassay that used a Luminex Multiplex platform. Purified capsular polysaccharides isolated from 12 serotypes of S. pneumonia were covalently attached to microbeads and used as a capturing reagent. Phycoerythrin conjugated anti-human IgG was used for detection. A positive immune response against a serotype was defined as a 2-fold increase or an increase of > 1 μg/mL from pre-vaccination levels.|Week 28 to Week 32 for Group A and Week 4 to Week 8 for Group B|Immune response per-protocol population: Group A – All patients randomized to Group A who received any rituximab infusion and any vaccine and had pre-vaccination and 4-week post-vaccination blood samples. Group B – All patients randomized to Group B who received any vaccine and had pre-vaccination and 4-week post-vaccination blood samples.||Percentage of patients|||Number
717703|NCT00282308|Secondary|Percentage of Patients With a 2-fold Increase in Tetanus Antibody Titers or With Tetanus Antibody Titers ≥ 0.2 IU/mL in Response to Tetanus Toxoid Adsorbed Booster Vaccine|The immune response to tetanus toxoid adsorbed booster vaccine was measured in serum samples immediately prior to and 4 weeks after vaccine administration. The tetanus antibody test was an ELISA that used tetanus toxoid as a capturing reagent and alkaline phosphatase-conjugated anti-human IgG (γ) for detection.|Week 24 to Week 28 for Group A and Day 1 to Week 4 for Group B|Immune response per-protocol population: Group A – All patients randomized to Group A who received any rituximab infusion and any vaccine and had pre-vaccination and 4-week post-vaccination blood samples. Group B – All patients randomized to Group B who received any vaccine and had pre-vaccination and 4-week post-vaccination blood samples.||Percentage of patients|||Number
717704|NCT00282308|Primary|Percentage of Patients With a Positive Immune Response to Tetanus Toxoid Adsorbed Booster Vaccine|The immune response to tetanus toxoid adsorbed booster vaccine was measured in serum samples immediately prior to and 4 weeks after vaccine administration. The tetanus antibody test was an ELISA that used tetanus toxoid as a capturing reagent and alkaline phosphatase-conjugated anti-human IgG (γ) for detection. For patients with pre-vaccination tetanus antibody titers < 0.1 IU/mL, a positive immune response was defined as an antibody titer ≥ 0.2 IU/mL. For patients with pre-vaccination tetanus antibody titers ≥ 0.1 IU/mL, a positive immune response to the booster immunization was defined as a 4-fold increase in antibody titer.|Week 24 to Week 28 for Group A and Day 1 to Week 4 for Group B|Immune response per-protocol population: Group A – All patients randomized to Group A who received any rituximab infusion and any vaccine and had pre-vaccination and 4-week post-vaccination blood samples. Group B – All patients randomized to Group B who received any vaccine and had pre-vaccination and 4-week post-vaccination blood samples.||Percentage of patients|||Number
717705|NCT00282334|Primary|Difference in Mean Daytime Systolic Ambulatory Blood Pressure From Baseline to Follow-up After Six Months|Comparison of mean change in daytime systolic ambulatory blood pressure from baseline to follow up after 6 months between the two groups|baseline and 6 months|Number of participants determined by power calculations. Analysis based on the principle of intention to treat with LOCF in cases missing at follow up.||mm Hg||Standard Deviation|Mean
717706|NCT00282334|Primary|Difference in Number of Patients Who Reached Target Blood Pressure||6 months||||||
717707|NCT00282347|Secondary|Change From Baseline in C3 and C4 Complement Levels at Week 52||Baseline to Week 52|Intent-to-treat population: All randomized participants who received any amount of study drug (rituximab or placebo).||mg/dL||Standard Deviation|Mean
717708|NCT00282347|Secondary|Change From Baseline in Anti-double-stranded DNA at Week 52||Baseline to Week 52|Intent-to-treat population: All randomized participants who received any amount of study drug (rituximab or placebo).||IU/mL||Standard Deviation|Mean
717709|NCT00282347|Secondary|Change From Baseline in the Systemic Lupus Erythematosus Expanded Health Survey Physical Function Score at Week 52|The systemic lupus erythematosus Expanded Health Survey is based on the Short Form 36 Health survey with additional questions specific to lupus. The physical function component score of the survey can range from 0-100. A higher score indicates better health. A positive change score indicates improvement.|Baseline to Week 52|Intent-to-treat population: All randomized participants who received any amount of study drug (rituximab or placebo).||Units on a scale||Standard Deviation|Mean
717710|NCT00282347|Secondary|Time to Achieve a Complete Renal Response||Baseline to Week 52|Intent-to-treat population: All randomized participants who received any amount of study drug (rituximab or placebo).||Weeks||95% Confidence Interval|Median
717711|NCT00282347|Secondary|British Isles Lupus Assessment Group (BILAG) Index Score Over 52 Weeks|The BILAG Index assesses 86 clinical signs and symptoms and laboratory measures of systemic lupus erythematosus in 8 organ system domains: General, mucocutaneous, neurological, musculoskeletal, cardiorespiratory, vasculitis, renal, and hematologic. Most of the 86 items are rated on the following scale: 0=Not present, 1=Improving, 2=Same, 3=Worse, 4=New. Some items are rated as either Yes or No. A single alphabetic score of A (very active) through E (not or never active) for each of the 8 domains is determined from the rating of the individual items in each domain. The total BILAG score is the sum of the scores of the 8 domains where A=9, B=3, C=1, D=0, and E=0. The total score ranges from 0 to 72 with a higher score indicating greater lupus activity. To calculate a BILAG score over the 52 week treatment period of the study, the area under the response-time curve of BILAG scores assessed every 4 weeks was divided by the number of days in the time curve minus the Baseline BILAG score.|Baseline to Week 52|Intent-to-treat population: All randomized participants who received any amount of study drug (rituximab or placebo).||Units on a scale||Standard Deviation|Mean
717712|NCT00282347|Secondary|Percentage of Participants With a Baseline Urine Protein to Creatinine Ratio of > 3.0 Who Achieved a Urine Protein to Creatinine Ratio of < 1.0 at Week 52||Baseline to Week 52|Intent-to-treat population: All randomized participants who received any amount of study drug (rituximab or placebo). Only those participants with a Baseline urine protein to creatinine ratio of > 3.0 were included in the analysis.||Percentage of participants|||Number
717727|NCT00282464|Secondary|Change in Global Clinical Improvement of Symptoms (CGI -I)|Change is observed value at each visit minus baseline value. CGI-I is an instrument for Global assessment of improvement in patient's condition. Scale range:0=not assessed, 1=very much improved, 7=very much worse|Baseline to Week 6|"Week 1 - Week 6 is Intent to treat (ITT) population Observed Cases.
Overall is Average of Weeks 1 – 6."||score on scale||Standard Error|Least Squares Mean
717714|NCT00282347|Secondary|Percentage of Participants Who Achieved a Complete Renal Response at Week 24 and Maintained it to Week 52|A participant had a complete renal response if they met the following 3 criteria: (1) Normalization of serum creatinine as evidenced by a serum creatinine level ≤ the upper limit of the normal range of central laboratory values or a serum creatinine level ≤ 15% greater than Baseline, if Baseline serum creatinine was within the normal range of the central laboratory values; (2) Inactive urinary sediment (as evidenced by < 5 red blood cells/high-power field and absence of red cell casts; (3) Urinary protein to creatinine ratio < 0.5.|Week 24 to Week 52|Intent-to-treat population: All randomized participants who received any amount of study drug (rituximab or placebo).||Percentage of participants|||Number
717715|NCT00282347|Primary|Percentage of Participants Who Achieved a Complete Renal Response (CRR), a Partial Renal Response (PRR), or no Renal Response (NRR) at Week 52|A participant had a CRR if they met the following 3 criteria: (1) Normalization of serum creatinine (SC) as evidenced by a SC level ≤ the upper limit of the normal range of central laboratory values or a SC level ≤ 15% greater than Baseline, if Baseline SC was within the normal range of the central laboratory values; (2) Inactive urinary sediment (as evidenced by < 5 red blood cells/high-power field (RBCs/HPF) and absence of red cell casts; (3) Urinary protein (UP) to creatinine ratio (CR) < 0.5. A participant had a PRR if they met the following 3 criteria: (1) A SC level ≤ 15% above Baseline; (2) RBCs/HPF ≤ 50% above Baseline and no RBC casts; (3) 50% improvement in the UP to CR, with 1 of the following conditions met: If the Baseline UP to CR was ≤ 3.0, then a UP to CR of < 1.0 or if the Baseline UP to CR was > 3.0, then a UP to CR of ≤ 3.0. A participant had a NRR if they did not achieve either a CRR or PRR.|Week 52|Intent-to-treat population: All randomized participants who received any amount of study drug (rituximab or placebo).||Percentage of participants|||Number
717716|NCT00282438|Primary|Disease Improvement|Worsening symptoms, pulmonary function studies, cardiac function and arrhythmia including EKG assessments, and neurological symptoms.|Participants are to be followed at 6 months and then yearly until 5 years||04/2020||||
717717|NCT00282438|Primary|Time to Disease Progression|Worsening symptoms, pulmonary function studies, cardiac function and arrhythmia including EKG assessments, and neurological symptoms.|Participants are to be followed at 6 months and then yearly until 5 years||04/2020||||
717718|NCT00282438|Primary|Survival|Patient has not died.|Participants are to be followed at 6 months and then yearly until 5 years||04/2020||||
717719|NCT00282438|Primary|Toxicity|Daily assessment will be made with regards to toxicity by one of the protocol investigators.National Cancer Institute Common Toxicity Criteria will be used to grade all non-hematologic toxicities. Toxicity grades as follows: 1 = Mild; 2 = Moderate; 3 = Severe and undesirable; 4 = life threatening or disabling ; 5 = Death|For length of hospital stay (until discharge).|||participants|||Number
717720|NCT00282464|Secondary|Change in Bipolar Cognition Rating Scale (BPCoRS) Subject Rating at Endpoint|Change is observed value at each visit minus baseline value. Subject Rating: Subject's perceived change in status using a 20-item instrument measuring cognitive deficits and degree of affect on funtioning. Scale 0 to 4, higher numbers reflecting greater impairment. Total possible score is 0 - 80. Endpoint is last observation carried forward.|Baseline to Week 6 (endpoint)|Endpoint is Intent to Treat (ITT) Last Observation Carried Forward (LOCF). n = 140, 162; N = 180, 190||score on scale||Standard Error|Least Squares Mean
717721|NCT00282464|Secondary|Change in Bipolar Cognition Rating Scale (BPCoRS) Global Rating by Interviewer|Change in Rating by interviewer, using BPCoRS, 20-item instrument measuring cognitive deficits and the degree of affect on functioning; 4 point scale with higher numbers reflecting greater impairment.Total possible score is 0 - 80.|Baseline to week 6 (endpoint)|Endpoint is Intent to Treat (ITT) population Last Observation Carried Forward (LOCF). n = 137, 158; N = 180, 190||score on scale||Standard Error|Least Squares Mean
717722|NCT00282464|Secondary|Change in Bipolar Cognition Rating Scale (BPCoRS) Informant Global Rating|Change is observed value at each visit minus baseline value. Informant Global Rating is interview with informant of subject using BPCoRS, a 20-item instrument measuring cognitive deficits & degree of affect on functioning. Scale: 0 to 4, higher numbers = greater impairment. Total possible score is 0 - 80. Endpoint is LOCF.|Baseline to week 6 (endpoint)|Baseline to Endpoint. Endpoint is ITT population Last Observation Carried Forward (LOCF). n = 97, 104; N = 180, 190||score on scale||Standard Error|Least Squares Mean
717723|NCT00282464|Secondary|Change in Bipolar Cognition Rating Scale (BPCoRS) Interviewer Global Rating of Subject|Change is observed value at each visit minus baseline value. BPCoRs: Subject interview with 20-items measuring cognitive deficits & degree of affect on functioning. Scale range:0 to 4, higher numbers, greater impairment. Total possible score is 0 - 80. Endpoint=last observation carried forward (LOCF)|Baseline to week 6 (endpoint)|Baseline to Endpoint. Endpoint is Intent to Treat (ITT) population Last Observation Carried Forward (LOCF). n = 141, 164; N = 180, 190||score on scale||Standard Error|Least Squares Mean
717724|NCT00282464|Secondary|Change in Sheehan Disability Scale (SDS) Total Score|Change is observed value at each visit minus baseline value. SDS is a patient rated measure of disability and impairment in work/school, social life, family life/home responsibilities. Scale range: 0-10 with 0=no disruption,10=extreme disruption. Total possible score is 0 - 30.|Baseline to week 6 (endpoint)|Baseline to Endpoint. Endpoint is ITT population Last Observation Carried Forward (LOCF). n = 149, 162; N = 180, 190||score on scale||Standard Error|Least Squares Mean
717725|NCT00282464|Secondary|Change in Quality of Life, Enjoyment, and Satisfaction Scale (Q-LES-Q) Total Score|Change is observed value at each visit minus baseline value. Q-LES-Q: 16- item instrument for a patient's assessment of his/her quality of life. Scale range: overall level of satisfaction 1=very poor to 5=Very good. 1 item (medication)can be left blank. Total possible score 15 - 80.|Baseline to week 6 (endpoint)|Change from baseline to Endpoint. Endpoint is Intent to Treat (ITT) population Last Observation Carried Forward (LOCF). n = 153, 168; N = 180, 190||score on scale||Standard Error|Least Squares Mean
717726|NCT00282464|Secondary|Change in Global Assessment of Functioning (GAF)|Change is observed value at each visit minus baseline value. GAF is an instrument used to assess global psychological, social, & occupational functioning. Scale range: 100 = normal and 0 = greatest abnormality.|Baseline to week 6 (Endpoint)|Endpoint is ITT population Last Observation Carried Forward (LOCF). n = 154, 169; N = 180, 190||score on scale||Standard Error|Least Squares Mean
718623|NCT00288639|Secondary|Number of Subjects With a Weight Gain at End of Treatment of at Least 7% Relative to Baseline|Count of subjects with a weight gain of at least 7 percent relative to baseline.|Baseline, End of 21-week treatment|"Safety population (all subjects who had taken at least
1 dose of study drug)."||participants|||Number
717730|NCT00282464|Secondary|Change in Hamilton Anxiety Rating (HAM-A)|Change is observed value at each visit minus baseline value. HAM-A:14-item scale to rate the intensity of psychic anxiety (items 1- 6, 14) and somatic anxiety (items 7-13) on a 5-point severity scale (0=not present to 4=very severe). Total possible score is 0 - 56.|Baseline to Weeks 3, 6|"Weeks 3, 6 are Intent to treat (ITT) population Observed Cases.
Endpoint is ITT population Last Observation Carried Forward (LOCF)."||score on scale||Standard Error|Least Squares Mean
717731|NCT00282464|Secondary|Change in Sleep Disturbance Factor Score|Change is observed value at each visit minus baseline value. Sleep Disturbance is the sum of scores of 3 items which pertain to sleep disturbance within Hamilton Depression Rating Scale (HAM-D). Scale range 0 to 4 with higher scores reflecting greater severity. Total possible score is 0 - 12.|Baseline to Weeks 3, 6|"Weeks 3, 6 are Intent to treat (ITT) population Observed Cases.
Endpoint is ITT population Last Observation Carried Forward (LOCF)"||score on scale||Standard Error|Least Squares Mean
717732|NCT00282464|Secondary|Change in Retardation Factor Scores|Change is observed value at each visit minus baseline value. Retardation Factor is the sum of scores of 4 items which pertain to retardation within HAM-D. Scores 0 to 4, higher scores reflecting greater severity.Total possible score is 0 - 16. Endpoint is LOCF.|Baseline to Weeks 3, 6|"Weeks 3, 6 are Intent to treat (ITT) population Observed Cases.
Endpoint is ITT population Last Observation Carried Forward (LOCF)."||score on scale||Standard Error|Least Squares Mean
717733|NCT00282464|Secondary|Change in Anxiety/Somatizations Factor Total Score|Change is observed value at each visit minus baseline value. This test is sum of Scores on 6 Items pertaining to anxiety/somatization within HAM-D. Scale range 0 to 4 with higher scores reflecting greater severity. Total possible score is 0 - 24. Endpoint is LOCF.|Baseline to Weeks 3, 6|"Weeks 3, 6 are Intent to treat (ITT) population Observed Cases.
Endpoint is ITT population Last Observation Carried Forward (LOCF)."||score on scale||Standard Error|Least Squares Mean
717734|NCT00282464|Secondary|Change in Bech Melancholia Score|Change is observed value at each visit minus baseline value. Bech Melancholia is sum of scores on 6 Items pertaining to melancholia within HAM-D. Scale range 0 to 4; higher scores, greater severity. Total possible score is 0 - 24. Endpoint is LOCF.|Baseline to Weeks 3, 6|"Weeks 3, 6 are Intent to Treat(ITT) population Observed Cases.
Endpoint is ITT population Last Observation Carried Forward (LOCF)."||score on scale||Standard Error|Least Squares Mean
717735|NCT00282464|Secondary|Change in Total Score in Hamiliton Depression Rating Scale (HAM-D 25)|Change is observed value at each visit minus baseline value. HAM-D: 25-item instrument measuring the range of depressive symptoms patient currently experiencing. Scale: 14 items 0-2 & 11 items 0-4; 0=absent or not depressed, 2 or 4=most severe or extreme. Total possible score is 0 - 72. Endpoint is LOCF.|Baseline to Weeks 3, 6|"Weeks 3, 6 are Intent to Treat (ITT) population Observed Cases.
Endpoint is ITT population Last Observation Carried Forward (LOCF)."||score on scale||Standard Error|Least Squares Mean
717736|NCT00282464|Secondary|Change in Hamilton Depression Rating Scale (HAM-D 17) Total Score|Change is observed value at each visit minus baseline value. HAM-D 17 Total score is first 17 items of HAM-D 25; measures range of depressive symptoms patient currently experiencing. Scale: 8 items 0-2 & 9 items 0-4; 0=absent or not depressed, 2 or 4=most severe or extreme. Total possible score is 0 - 52.Endpoint is LOCF|Baseline to Weeks 3, 6|"Weeks 3, 6 are Intent to Treat (ITT) population Observed Cases.
Endpoint is ITT population Last Observation Carried Forward (LOCF)."||score on scale||Standard Error|Least Squares Mean
717737|NCT00282464|Primary|Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|Change is observed value at each visit minus baseline value. MADRS:10-item instrument measuring depression; scale range between 0(Normal) - 6(most abnormal)for each item. Total possible score is 0 - 60. Overall is average response Week 1 - Week 6.|Baseline to Week 6|"Weeks 1 - 6 are Intent to treat (ITT) population Observed Cases.
Overall is Average of Weeks 1 - 6."||score on scale||Standard Error|Least Squares Mean
717738|NCT00282464|Secondary|Remission as Measured by Hamilton Asberg Depression Rating Scale (HAM-D 17) Total Score Less Than or Equal to 7|Remission response is yes when HAM-D 17 total score is less than or equal to 7; if not, response is no. Total score is first 17 items of HAM-D 25, measures range of depressive symptoms. Scale: 8 items 0-2 and 9 items 0-4, higher scores more severe. Total possible score is 0 - 52. Endpoint is LOCF.|Week 3, Week 6|"Weeks 3, 6 are Intent to treat (ITT) population Observed Cases.
Not all subjects responded at each week.
Endpoint is ITT population Last Observation Carried Forward (LOCF)"||Participants|||Number
717739|NCT00282464|Secondary|Remission as Measured by Montgomery Asberg Depression Scale (MADRS) Total Score Less Than or Equal to 12|Remission response is yes if MADRS total score less than or equal to 12; if not, response is no. MADRS: 10-item instrument measuring depression; scale 0(Normal) & 6(most abnormal).Total possible score is 0 - 60. Endpoint is LOCF.|Week 1 to Week 6|"Weeks 1 - 6 are Intent to treat (ITT) population Observed Cases.
Not all subjects responded at each week.
Endpoint is ITT population Last Observation Carried Forward (LOCF)"||Participants|||Number
717740|NCT00282464|Secondary|Response Greater Than or Equal to 50 Percent Decrease From Baseline in Hamilton Depression Rating Scale (HAM-D 17) Total Score|Participants with greater than or equal to 50 percent decrease from baseline in HAM-D 17 total score responded yes; others responded no. Total score is first 17 items of the HAM-D 25: measures range of depressive symptoms. Scale: 8 items 0-2 & 9 items 0-4, higher scores being more severe. Total possible score is 0 - 52. Endpoint is LOCF.|Baseline to Week 3, Week 6|"Weeks 3, 6 are Intent to treat (ITT) population Observed Cases.
Not all subjects responded at each week.
Endpoint is ITT population Last Observation Carried Forward (LOCF)"||Participants|||Number
717741|NCT00282464|Secondary|Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Rating Scale (MADRS) Total Score|Participants with MADRS Total Score greater than or equal to 50 percent decrease from baseline responded yes; others responded no. MADRS: 10-item instrument measuring depression; scale 0(Normal) & 6 (most abnormal)for each item. Total possible score is 0 - 60. Endpoint is last observation carried forward (LOCF)|Baseline to Week 6|"Weeks 1 - 6 are Intent to treat (ITT) population Observed Cases
Not all subjects responded at each week.
Endpoint is ITT population Last Observation Carried Forward (LOCF)"||participants|||Number
717756|NCT00282568|Primary|Graft Survival|Graft survival was defined as any participant who did not meet the definition of graft loss, where graft loss was defined as graft failure (re-transplant or permanent return to dialysis (for more than 30 days)) or participants death.|From enrollment until the end of study (up to 60 months).|Modified full analysis set, defined as all patients who took at least one dose of tacrolimus MR during the extension portion of the study.||percentage of participants||95% Confidence Interval|Number
717742|NCT00282568|Secondary|Safety as Assessed by Adverse Events, Laboratory Parameters and Vital Signs|"An adverse event was defined as any reaction, side effect or other untoward medical occurrence, regardless of the relationship to study drug which occurred during the conduct of a clinical study. Clinically significant adverse changes in clinical status, routine laboratory studies or physical examinations were considered adverse events.
A serious adverse event was any adverse event occurring at any dose that resulted in any of the following outcomes:
Death
Life-threatening adverse event
Inpatient hospitalization or prolongation of existing hospitalization
Persistent or significant disability or incapacity
Congenital abnormality or birth defect
Important medical event."|From the first dose of tacrolimus MR formulation through the day of last dose plus 10 days (approximately 60 months).|Modified safety analysis set||participants|||Number
717743|NCT00282568|Secondary|Number of Participants Returning to Permanent Dialysis|Permanent dialysis defined as dialysis for longer than 30 days.|From enrollment until the end of study (up to 60 months).|Modified full analysis set||participants|||Number
717744|NCT00282568|Secondary|Primary Reason for Graft Loss|The primary reason for graft loss was recorded by the Investigator. Graft loss was defined as graft failure (re-transplant or permanent return to dialysis) or death. GBM = glomerular basement membrane.|From enrollment until the end of study (up to 60 months).|Participants in the modified full analysis set with graft loss.||participants|||Number
717745|NCT00282568|Secondary|Number of Participants With Treatment Failure|Treatment failure was defined as discontinuation of study drug for any reason. Due to discontinuation of the study by the sponsor, treatment failure was not analyzed.|From enrollment until the end of study (up to 60 months).||||||
717746|NCT00282568|Secondary|Number of Participants With Chronic Rejection|Due to the low number of participants with biopsy-confirmed acute rejection episodes, chronic rejection was not analyzed.|From enrollment until the end of study (up to 60 months).||||||
717747|NCT00282568|Secondary|Number of Participants With Clinically Treated Acute Rejection Episodes|A clinically treated acute rejection episode was any biopsy-confirmed or suspected rejection episode that was treated with immunosuppressive therapy.|From enrollment until the end of study (up to 60 months).|Modified full analysis set||participants|||Number
717748|NCT00282568|Secondary|Number of Participants With Multiple Rejection Episodes|This analysis includes rejection episodes that were either confirmed by biopsy by the clinical site pathologist or were clinically treated.|From enrollment until the end of study (up to 60 months).|Modified full analysis set||participants|||Number
717749|NCT00282568|Secondary|Number of Participants Receiving Anti-lymphocyte Antibody Therapy for Acute Rejection|Steroid-resistant rejection episodes were treated with anti-lymphocyte antibodies. If a participant had a histologically proven Banff Grade II or III rejection, they could be initiated on anti-lymphocyte antibody treatment per institutional practice. Biopsies were graded by the pathologist at the clinical site according to the 1997 Banff criteria: Borderline: No intimal arteritis present but foci of mild tubulitis; Grade I: Significant interstitial infiltration and foci of moderate to severe tubulitis; Grade II: Mild to severe intimal arteritis; Grade III: Transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic infiltrate in vessel.|From enrollment until the end of study (up to 60 months).|Modified full analysis set||participants|||Number
717750|NCT00282568|Secondary|Grade of Biopsy-confirmed Acute Rejection Episodes|"Biopsy-confirmed acute rejection (BCAR) is defined as an episode of acute allograft rejection that was confirmed by biopsy results and was Banff grade ≥ IA. Biopsies were graded by the pathologist at the clinical site according to the 1997 Banff criteria: Borderline: No intimal arteritis present but foci of mild tubulitis; Grade I: Significant interstitial infiltration and foci of moderate to severe tubulitis; Grade II: Mild to severe intimal arteritis; Grade III: Transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic infiltrate in vessel.
For participants with more than one biopsy-confirmed acute rejection episode, the worst case grade is reported."|From enrollment until the end of study (up to 60 months).|Participants in the modified full analysis set with a biopsy-confirmed acute rejection.||participants|||Number
717751|NCT00282568|Secondary|Time to First Biopsy-confirmed Acute Rejection|For participants with a biopsy-confirmed acute rejection, the median number of days from enrollment to the date of biopsy confirmation. Biopsy-confirmed acute rejection (BCAR) is defined as an episode of acute allograft rejection that was confirmed by biopsy results and was Banff grade ≥ IA. Biopsies were graded by the pathologist at the clinical site according to the 1997 Banff criteria: Borderline: No intimal arteritis present but foci of mild tubulitis; Grade I: Significant interstitial infiltration and foci of moderate to severe tubulitis; Grade II: Mild to severe intimal arteritis; Grade III: Transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic infiltrate in vessel.|From enrollment until the end of study (up to 60 months).|Participants in the modified full analysis set with a biopsy-confirmed acute rejection.||days||Full Range|Median
717752|NCT00282568|Secondary|Time to Event for Graft Non Survival|For participants with graft loss, the median number of days from enrollment to graft loss. Graft loss was defined as graft failure (re-transplant or permanent return to dialysis (for more than 30 days)) or participant death.|From enrollment until the end of study (up to 60 months).|Participants in the modified full analysis set with graft loss.||days||Full Range|Median
717753|NCT00282568|Secondary|Time to Event for Patient Non Survival|For participants who died on study, the median number of days from enrollment to death due to any cause.|From enrollment until the end of study (up to 60 months).|Participants in the modified full analysis set who died on study.||days||Full Range|Median
717754|NCT00282568|Secondary|Change From Baseline in Creatinine Clearance|Renal function was assessed using creatinine clearance levels calculated using the Cockcroft-Gault formula, over the course of the study.|Baseline (the last day of tacrolimus on Day 7), Day 35 (end of the pharmacokinetic phase) and end of treatment (EOT; the last observed value during treatment, maximum time on study was 60 months).|Modified safety analysis set||mL/minute||Standard Deviation|Mean
717755|NCT00282568|Secondary|Change From Baseline in Serum Creatinine|Renal function was assessed using serum creatinine levels over the course of the study.|Baseline (the last day of tacrolimus on Day 7), Day 35 (end of the pharmacokinetic phase) and end of treatment (EOT; the last observed value during treatment, maximum time on study was 60 months).|Modified safety analysis set defined as all patients who took at least 1 dose of tacrolimus and at least one dose of tacrolimus MR during the pharmacokinetic portion of the study. “N” indicates the number of participants with available data at each time point.”||mg/dL||Standard Deviation|Mean
717757|NCT00282568|Primary|Patient Survival|Patient Survival defined as any participant who did not die by the time of analysis.|From enrollment until the end of study (up to 60 months).|Modified full analysis set, defined as all patients who took at least one dose of tacrolimus MR during the extension portion of the study.||percentage of participants||95% Confidence Interval|Number
717758|NCT00282568|Primary|Time to Maximum Observed Concentration of Tacrolimus (Tmax)|The time to reach the maximum concentration of tacrolimus was calculated from whole blood tacrolimus concentrations for both tacrolimus and tacrolimus MR at steady state, without interpolation.|For tacrolimus, Days 1 and 7 at 0 (pre-dose), 0.5, 1, 2, 3, 6, 8, 12 (pre-dose), 13, 14, 15, 18, 20, and 24 hours. For tacrolimus MR, Days 14 and 21 pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 18, 20, and 24 hours post-dose.|The number of participants analyzed represents the trough evaluable set defined as all patients with replicate trough measurements for both tacrolimus and tacrolimus MR.||hours||Standard Deviation|Mean
717759|NCT00282568|Primary|Minimum Concentration of Tacrolimus (Cmin)|The trough (minimum) concentration of tacrolimus determined from the tacrolimus whole blood concentration value at the 24-hour time point post- dose, prior to receiving the next dose.|Days 1 and 7 (tacrolimus) and Days 14 and 21 (tacrolimus MR), 24 hours post-dose.|The number of participants analyzed represents the trough evaluable set defined as all patients with replicate trough measurements for both tacrolimus and tacrolimus MR.||ng/mL||Standard Deviation|Mean
717760|NCT00282568|Primary|Maximum Observed Concentration (Cmax) of Tacrolimus|The maximum concentration was calculated from whole blood tacrolimus concentrations for both tacrolimus and tacrolimus MR at steady state, without interpolation.|For tacrolimus, Days 1 and 7 at 0 (pre-dose), 0.5, 1, 2, 3, 6, 8, 12 (pre-dose), 13, 14, 15, 18, 20, and 24 hours. For tacrolimus MR, Days 14 and 21 pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 18, 20, and 24 hours post-dose.|The number of participants analyzed represents the Pharmacokinetic evaluable set.||ng/mL||Standard Deviation|Mean
717761|NCT00282568|Secondary|Percentage of Participants With Biopsy-confirmed Acute Rejection|Biopsy-confirmed acute rejection (BCAR) is defined as an episode of acute allograft rejection that was confirmed by biopsy results and was Banff grade ≥ IA. Biopsies were graded by the pathologist at the clinical site according to the 1997 Banff criteria: Borderline: No intimal arteritis present but foci of mild tubulitis; Grade I: Significant interstitial infiltration and foci of moderate to severe tubulitis; Grade II: Mild to severe intimal arteritis; Grade III: Transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic infiltrate in vessel.|From enrollment until the end of study (up to 60 months).|Modified full analysis set||percentage of participants||95% Confidence Interval|Number
717762|NCT00282568|Primary|Area Under the Concentration-time Curve From Time 0 to 24 Hours (AUC0-24) for Tacrolimus|The area under the concentration-time curve was calculated from whole blood tacrolimus concentrations for both tacrolimus and tacrolimus MR at steady state using the trapezoidal rule.|For tacrolimus, Days 1 and 7 at 0 (pre-dose), 0.5, 1, 2, 3, 6, 8, 12 (pre-dose), 13, 14, 15, 18, 20, and 24 hours. For tacrolimus MR, Days 14 and 21 pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 18, 20, and 24 hours post-dose.|The number of participants analyzed represents the Pharmacokinetic evaluable set, defined as patients with all five complete pharmacokinetic profiles (two tacrolimus and three tacrolimus MR).||ng*hr/mL||Standard Deviation|Mean
717763|NCT00282672|Primary|5 Year Extension: % of All Patients Enrolled in the Extension Protocol and Available for Analysis Demonstrating CR-D at 5 Years|For patient who made it to the 5 year visit, % of patients demonstrating complete eradication of dysplasia was calculated and all were free of dysplasia|5 years|||percentage of participants|||Number
717764|NCT00282672|Secondary|5 Year Extension: All Cause Mortality of the Group From 2 to 5 Years.||5 years|||percentage of participants|||Number
717765|NCT00282672|Secondary|5 Year Extension: Serious Adverse Event Incidence||5 years|||participants|||Number
717766|NCT00282672|Secondary|5 Year Extension: Proportion (%) of All Patients Enrolled in This Extension Protocol and Available for Analysis Demonstrating CR-D at 4 Year||4 years|||percentage of participants|||Number
717767|NCT00282672|Secondary|5 Year Extension: Proportion (%) of All Patients Enrolled in This Extension Protocol and Available for Analysis Demonstrating CR-IM at 3 Year||3 years|||percentage of participants|||Number
717768|NCT00282672|Secondary|5 Year Extension: Proportion (%) of All Patients Enrolled in This Extension Protocol and Available for Analysis Demonstrating CR-IM at 4 Year||4 years|||percentage of participants|||Number
717769|NCT00282672|Secondary|5 Year Extension:Proportion (%) of All Patients Enrolled in This Extension Protocol and Available for Analysis Demonstrating CR-D at 5 Year||5 years|||percentage of participants|||Number
717770|NCT00282672|Secondary|5 Year Extension: Proportion (%) of All Patients Enrolled in This Extension Protocol and Available for Analysis Demonstrating CR-IM at 5 Year||5 years|||percentage of participants|||Number
717771|NCT00282672|Secondary|5 Year Extension: Proportion (%) of All Patients Enrolled in This Extension and Available for Analysis at 5 Years Demonstrating Any Adenocarcinoma in Any Biopsy Obtained From the Esophageal Body After 2 Years and Inclusive of the 5 Year Visit||5 years|Similar analysis was performed and the result is provided for the outcome measure #14. The data were collected to answer the outcome measure #14.|||||
717772|NCT00282672|Secondary|For 5 Year Extension: Proportion (%) of All Patients Enrolled in This Extension and Available for Analysis at 5 Years Demonstrating Any Adenocarcinoma in Any Biopsy Obtained From the Esophageal Body Since Primary RFA (0-5 Years)||5 years|41 LGD patients and 21 HGD subjects completed the 5 year study and used for analysis.||percentage of participants|||Number
717773|NCT00282672|Secondary|Adverse Event Incidence|Data reported in the adverse event section|12 months for Treatment and Sham Comparison||||||
717774|NCT00282672|Secondary|Quality of Life Questionnaire (Baseline v. 12 and 24 Mos)||0, 12, and 24 months|Data had not been collected consistently to analyze the data.|||||
717775|NCT00282672|Secondary|Subject Discomfort : Chest Pain Score on Day 1|Chest pain score was measured on a visual analogue scale of 0 to 100, with higher scores indicating a greater severity of pain|Day 1 , if ablated|||Scores on a scale||Inter-Quartile Range|Median
717776|NCT00282672|Primary|Durability of Eradication With no Additional Treatments||5 year|41 LGD subjects and 32 HGD subjects completed 5 year visit||percentage of participants|||Number
717777|NCT00282672|Secondary|Progression of Dysplasia (i.e., HGD to Adenocarcinoma, or LGD to HGD or Adenocarcinoma)||5 year|||participants|||Number
717781|NCT00282672|Primary|5 Year Extension: % of All Patients Enrolled in the Extension Protocol and Available for Analysis Demonstrating CR-IM at 5 Years|For patient who made it to the 5 year visit, % of patients demonstrating complete eradication of intestinal metaplasia (CE-IM) was calculated.|5 years|patient who made it to the 5 year visit||percentage of participants|||Number
717782|NCT00282672|Primary|The % of Patients With Complete Histological Clearance of Intestinal Metaplasia at 24 Months.|% of patients with complete eradication of IM out of the number of participants analyzed at 24 month was calculated.|24 Month|||percentage of participants|||Number
717783|NCT00282672|Primary|The % of Patients With Complete Eradication of Dysplasia at 12 Month|% of patients with complete eradication of Dysplasia out of the number of participants analyzed at 12 month was calculated.|12 month|LGD: Radiofrequency group- 2 patients withdrew and were not analyzed, HGD: Radiofrequency Ablation: 4 patients withdrew and were not analyzed. LGD Sham procedure first then LGD Radiofrequency Ablation group and HGD Sham procedure first then HGD Radiofrequency Ablation group were not analyzed to measure the CR-D at one year.||percentage of participants|||Number
717784|NCT00282672|Primary|The % of Patients With Complete Eradication of Intestinal Metaplasia (IM) at 12 Month|% of patients with complete eradication of IM out of the number of participants analyzed at 12 month was calculated.|12 month|LGD: Radiofrequency group- 2 patients withdrew and were not analyzed, HGD: Radiofrequency Ablation: 4 patients withdrew and were not analyzed. LGD Sham procedure first then LGD Radiofrequency Ablation group and HGD Sham procedure first then HGD Radiofrequency Ablation group were not analyzed to measure the CR-IM at one year.||percentage of participants|||Number
717785|NCT00282815|Secondary|Barthel Index|Barthel Index score range: 0 (worst, fully dependent) - 100 (best, independent).|3 months|||units on a scale (range 0-100)||Inter-Quartile Range|Median
717786|NCT00282815|Primary|Number of Subjects Who Withdraw From Study.|Prespecified outcome.|3 months|||participants|||Number
717787|NCT00282815|Primary|Cumulative Continuous Positive Airway Pressure (CPAP)/Sham CPAP Usage Hours Over the 3 Month Period.||3 months|Data not available on one sham participant (lowering n from 11 to 10 in the shame group).||Hours/participant||Inter-Quartile Range|Median
717788|NCT00282828|Secondary|Post-treatment Social Phobia Severity as Defined by Endpoint LSAS Scores|The Liebowitz Social Anxiety Scale (LSAS) is a 24-item scale assessing fear and avoidance in social and performance situations; it is widely used in studies of pharmacological treatment of Generalized Social Anxiety Disorder (GSAD). We analyzed the overall change in LSAS (last Phase II LSAS minus Week 10 LSAS). Higher numbers reflect greater drops in social anxiety disorder severity. Scores on the LSAS range from 0 to 144, with higher scores indicating greater pathology.|Change from Week 10 to Week 22|This analysis was conducted in Phase I non-responders, randomized to receive 12 weeks of continued sertraline plus the addition of clonazepam, switch to venlafaxine, or prolonged sertraline plus placebo.||units on a scale||Standard Deviation|Mean
717789|NCT00282828|Primary|Rates of Remission (LSAS≤30) After 12 Weeks of Randomized Treatment During Phase II, Among Phase I Non-responders|The Liebowitz Social Anxiety Scale (LSAS) is a 24-item scale assessing fear and avoidance in social and performance situations; it is widely used in studies of pharmacological treatment of Generalized Social Anxiety Disorder (GSAD). Scores on the LSAS range from 0 to 144, with higher scores indicating greater pathology.|Measured at Week 22 (Endpoint)|The present analysis was conducted in the modified ITT population (n=181), with remission based on week 22 LSAS for study completers (n=154, and last Phase II LSAS for the 27 patients who terminated early.||participants|||Number
717790|NCT00282867|Post-Hoc|Target Glucose Concentration|glucose in target range in first 24 hours|first 24 hours after initiation of treatment|"Per protocol no analysis of this endpoint was performed in the usual care group."||participants|||Number
717791|NCT00282867|Other Pre-specified|Symptomatic Hypoglycemia|symptomatic hypoglycemia (glucose < 55 mg/dL)during treatment period|up to 5 days|||participants|||Number
717792|NCT00282867|Primary|Hypoglycemic Events|hypoglycemic events|up to 5 days|||participants|||Number
717793|NCT00282867|Secondary|Favorable 3 Month Modified Rankin|3 month functional outcomes by modified Rankin (0 to 1) dichotomized as favorable versus not favorable outcome. Construct is functional handicap.|3 months|||percentage of participants|||Number
717794|NCT00282919|Secondary|Parasite Clearance Time|Asexual P falciparum parasite clearance time was defined as the time from baseline to the first of the 3 consecutive 0 parasite counts.|Baseline up to Day 42|Data not possible to report, as clearance time was obtained as life table plots only, as per planned analysis.|||||
717795|NCT00282919|Secondary|Fever Clearance Time|Fever clearance time (FCT) was defined as the time from baseline to the first of 2 consecutive time points with temperature less than (<) 37.5 degree Celsius (C) (axillary temperature) or <38 degree C (oral temperature).|Baseline up to Day 42|Data not possible to report, as clearance time was obtained as life table plots only, as per planned analysis.|||||
717796|NCT00282919|Secondary|Percentage of Participants With Gametocyte Clearance|Gametocyte clearance was defined as clearance of P falciparum gametocytemia (defined as attainment of 3 consecutive 0 gametocyte counts) without subsequent recurrence through the day of consideration. Recurrence was defined as the reappearance of asexual P. falciparum gametocytemia after achieving clearance. Percentage of participants with gametocyte clearance were reported.|Day 7, 14, 21, 28, 35, 42|"Parasitologic PP population. Here, N (Number of participants analyzed) signifies those who were evaluable for this outcome measure and n signifies number of participants who were evaluated at given time point."||percentage of participants||90% Confidence Interval|Number
717797|NCT00282919|Secondary|Percentage of Participants With Parasite Clearance at Day 7, 14, 21, 35, 42|Parasite clearance was defined as the clearance of asexual Plasmodium falciparum (P falciparum) parasitemia (defined as three consecutive 0 parasite counts) within 7 days of initiation of treatment, without subsequent recrudescence up to Day 28. Failure to achieve clearance of asexual P falciparum parasitemia was defined as parasitemia not cleared within 7 days of initiation of treatment, or subsequent recrudescence (confirmed by molecular testing) by Day 28 after achieving clearance. Percentage of participants with clearance is reported. Here “N” (Number of participants analyzed) signify participants who were evaluable (parasitological per protocol) at Day 28.|Day 7, 14, 21, 35, 42|"Parasitologic PP population. Here, N (Number of participants analyzed) signifies those participants who were evaluable for this outcome measure and n signifies number of participants who were evaluated at given time point."||percentage of participants||90% Confidence Interval|Number
717798|NCT00282919|Secondary|Percentage of Participants With Clinical Cure|Clinical Cure is defined as resolution of the participant’s fever and other symptoms attributed to P falciparum malaria (for example, abdominal pain, malaise, and headache).|Day 3, 7, 28, and 42|"Parasitologic PP population. Here, N (Number of participants analyzed) signifies those who were evaluable for this outcome measure."||percentage of participants||90% Confidence Interval|Number
717799|NCT00282919|Secondary|Percentage of Participants With Resistance to Treatment|Resistance is measured by clearance of asexual P falciparum parasitemia and categorized into 3 levels; resistance I (RI): clearance of asexual P. falciparum parasitemia before Day 7 followed by recurrence on or after Day 7, resistance II (RII): marked reduction (<=25% of baseline) of asexual P. falciparum parasitemia but no clearance prior to and up to Day 7, and resistance III (RIII): no marked reduction (>25% of baseline) of asexual P. falciparum parasitemia. Recurrence was defined as the reappearance of asexual P. falciparum parasitemia following a quiescent or latent period after the cessation of the primary attack. Percentage of participants with resistance as measured by RI, RII and RIII is reported.|Days 7, 14, 21, 28, 35, 42|"Parasitologic PP population. Here, N (Number of participants analyzed) signifies those who were evaluable for this outcome measure and n signifies number of participants who were evaluated at given time point."||percentage of participants|||Number
717800|NCT00282919|Secondary|Percentage of Participants With Late Treatment Failures (LTF)|LTF included late clinical failure (LCF) and late parasitologic failure (LPF). LCF is defined as a participant meeting any of these criteria: development of signs or symptoms of severe malaria after Day 3 in the presence of P falciparum parasitemia, without previously meeting any of the criteria of ETF or presence of P falciparum parasitemia and fever or history of fever on any day from Day 4 to Day 28, without previously meeting any of the criteria of ETF. LPF is defined as presence of P falciparum parasitemia on any day from Day 7 to Day 28 and the absence of fever or history of fever without previously meeting any of the criteria of ETF or LCF.|Baseline up to Day 28|"Parasitologic PP population. Here, N (Number of participants analyzed) signifies those who were evaluable for this outcome measure."||percentage of participants||90% Confidence Interval|Number
717801|NCT00282919|Secondary|Percentage of Participants With Early Treatment Failures (ETF)|ETF was defined as a participant meeting any of these criteria: development of signs of severe malaria (impaired consciousness [for example, obtundation, unarousable coma, delirium, stupor], respiratory distress [respiratory rate greater than or equal to {>=} 30 breaths/minute], seizures, hypoglycemia [glucose less than or equal to {<=} 40 milligram/deciliter], gross hematuria, increase in parasitemia to greater than 100,000 parasites/microliter in 48 hours or later after the first treatment dose was administered) any day from Day 0 to 3 in the presence of P falciparum parasitemia; parasite count on Day 2 > Day 0 (baseline), irrespective of axillary or oral temperature; parasite count on Day 3 > 37.5 degrees Celsius (axillary temperature) and >38 degrees Celsius (oral temperature) and parasite count on Day 3 >=25 percent (%) of the first available parasite density on Day 0 (baseline).|Baseline up to Day 28|"Parasitologic PP population. Here, N (Number of participants analyzed) signifies those who were evaluable for this outcome measure."||percentage of participants||90% Confidence Interval|Number
717802|NCT00282919|Primary|Percentage of Participants With Parasite Clearance at Day 28|Parasite clearance was defined as the clearance of asexual Plasmodium falciparum (P falciparum) parasitemia (defined as three consecutive 0 parasite counts) within 7 days of initiation of treatment, without subsequent recrudescence up to Day 28. Failure to achieve clearance of asexual P falciparum parasitemia was defined as parasitemia not cleared within 7 days of initiation of treatment, or subsequent recrudescence (confirmed by molecular testing) by Day 28 after achieving clearance. Percentage of participants with clearance is reported. Here “N” (Number of participants analyzed) signify participants who were evaluable (parasitological per protocol) at Day 28.|Day 28|Parasitological per protocol (PP) population: Participants who had study drug for 3 days unless treatment failure, no concomitant anti-malarial unless designated treatment failure, had test of cure at Day 28, baseline smear with parasitemia between 1000-100000 parasites/microliter, rapid diagnostic test positive for P falciparum, history of fever.||percentage of participants||90% Confidence Interval|Number
717803|NCT00282971|Secondary|Change From Baseline in FEV1 at Week 24 LOCF||24 weeks|Out of 180 and 171 subjects that were treated with study drug and usual care, respectively, the Full Analysis Set (FAS)for each group which was analyzed for efficacy, was 179 and 170 subjects, respectively.FEV1=forced expiratory volume in 1 second;LOCF=last observation carried forward.||Liter||Standard Deviation|Mean
717804|NCT00282971|Secondary|Percentage of Participants Achieving Glycemic Control by Visit|2 definitions of good glycemic control were used: an HbA1c result of ≤6.5% or ≤7.0%|4, 12 and 24 weeks|Out of 180 and 171 subjects that were treated with study drug and usual care, respectively, the Full Analysis Set (FAS)for each group which was analyzed for efficacy, was 179 and 170 subjects, respectively. LOCF=last observation carried forward.||Percentage of participants|||Number
717805|NCT00282971|Primary|Percentage Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|[(week 24 value - baseline value)/baseline value]*100%|4, 12 and 24 weeks|Out of 180 and 171 subjects that were treated with study drug and usual care, respectively, the Full Analysis Set (FAS)for each group which was analyzed for efficacy, was 179 and 170 subjects, respectively.||percentage change||Standard Deviation|Mean
717806|NCT00282984|Secondary|Number of Long-Term Quit Responders From Week 9 Through Week 24|Responders: participants were considered Long Term Quit Responders if 1) they were responders for the primary endpoint (the 4-week CQR for Weeks 9-12) and 2) had no more than 6 days of smoking from Week 12 through the given visit.|Week 9 through Week 24|All Participants population||participants|||Number
717807|NCT00282984|Secondary|Cigarettes Smoked Per Day|Cigarettes smoked each day during the first 3 weeks of the treatment phase.|Day 21|All Participants population||cigarettes per day||Standard Deviation|Mean
717808|NCT00282984|Secondary|Number of Responders With Continuous Abstinence (CA) Through Week 24|Responders: participants who remained abstinent based on ‘since the last contact’ question in Nicotine Use Inventory 1) “Has participant smoked any cigarettes (even a puff) since the last contact?” = No AND 2) “Has participant used any other tobacco products… since the last contact?” = No. Non- responder if the expired CO > 10 ppm at any given timepoint.|Week 9 through Week 24|All Participants population||participants|||Number
717848|NCT00283439|Primary|Change in Platelet Nadir|Change in platelet nadir from the previous qualifying cycle to the first treatment cycle.|32 weeks|Efficacy Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim, completed the first treatment cycle, and were not replaced per the protocol.||10^9/L||Standard Error|Mean
717809|NCT00282984|Secondary|Number of Participants With a 4 Week Point Prevalence of Smoking Cessation|Responders: participants with abstinence during the last 4 weeks of non-treatment based on answering 'no' to both of the two ‘last 4 week' questions in the Nicotine Use Inventory (NUI). NUI collected information of cigarette or other nicotine use during the study.|Week 48 through Week 52 (final 4 weeks of non-treatment period [pd])|All Participants population||participants|||Number
717810|NCT00282984|Secondary|Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 52|Responders: abstinence in previous seven days, defined in the non-treatment follow-up as: 1) “Has the participant smoked any cigarettes in the last 7 days?” = No AND 2) “Has the participant used any other tobacco products in the last 7 days?” = No. Participant a non-responder if expired CO > 10 ppm.|Week 52|||participants|||Number
717811|NCT00282984|Secondary|Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 24|Responders: abstinence in previous seven days, defined in the non-treatment follow-up as: 1) “Has the participant smoked any cigarettes in the last 7 days?” = No AND 2) “Has the participant used any other tobacco products in the last 7 days?” = No. Participant a non-responder if expired CO > 10 ppm.|Week 24|||participants|||Number
717812|NCT00282984|Secondary|Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 12|Responders: abstinence in previous seven days, defined in the non-treatment follow-up as: 1) “Has the participant smoked any cigarettes in the last 7 days?” = No AND 2) “Has the participant used any other tobacco products in the last 7 days?” = No. Participant a non-responder if expired CO > 10 ppm.|Week 12|All Participants population||participants|||Number
717813|NCT00282984|Secondary|Number of Long-Term Quit Responders|Responders: participants were considered Long Term Quit responders if 1) they were responders for the primary endpoint (the 4-week CQR for Weeks 9-12) and 2) had no more than 6 days of smoking from Week 12 through the given visit.|Week 9 through Week 52|All participants population||participants|||Number
717814|NCT00282984|Secondary|Number of Responders With Continuous Abstinence (CA) Through Week 52|Responders: participants who remained abstinent based on ‘since the last contact’ question in Nicotine Use Inventory 1) “Has participant smoked any cigarettes (even a puff) since last contact?” = No AND 2) “Has participant used any other tobacco products… since last contact?” = No. Participant a non-responder if expired CO > 10 ppm.|Week 9 through Week 52|All participants population||participants|||Number
717815|NCT00282984|Primary|Number of Responders With Carbon Monoxide (CO) Confirmed 4-week Continuous Quit Rate (CQR) for Last 4 Weeks of Treatment (Trtmt)|Participants considered Responders (4-week CQR <=10 parts per million <ppm>) through reports of cigarette or other nicotine use since last study visit, confirmed by measurement of end-expiratory exhaled carbon monoxide (CO). If any CO measurement at a particular timepoint was >10 ppm, subject was considered to be Non-Responder at that timepoint.|weeks 9 through 12|"Primary analysis population (Modified Intent-to-Treat) included all participants who took at least 1 dose randomized study medication. Participants who discontinued study were assumed smokers from timepoint of discontinuation through end of study. Modified Intent-to-Treat population is referred to as All Participants population in this report."||participants|||Number
717816|NCT00283049|Secondary|Rate of Hypoglycemia, Symptomatic Hypoglycemia, Severe Hypoglycemia and Serious Hypoglycemia|"Symptomatic hypoglycemia (BG<70 mg/dL, BG<50 mg/dL): including 1 or more symptoms: headache, dizziness, general feeling of weakness, drowsiness, confusion, pallor, irritability, trembling, sweating, rapid heartbeat & a cold, clammy feeling.
Mild–to-moderate hypoglycemia: SMBG ≥ 36 mg/dL but <70 mg/dL
Severe hypoglycemia: assistance of another party is required & either:
SMBG of <36 mg/dL, or
with prompt response to treatment with oral carbohydrates, IV glucose or glucagon.
Serious hypoglycemia:
Hypoglycemia with coma/loss of consciousness Or Hypoglycemia seizure/convulsion."|60 Weeks from Baseline|Safety Population||events/ patient-year||Standard Deviation|Mean
717817|NCT00283049|Secondary|Occurrences of Hypoglycemia, Symptomatic Hypoglycemia, Severe Hypoglycemia, and Serious Hypoglycemia|"Symptomatic hypoglycemia (BG<70 mg/dL, BG<50 mg/dL): including 1 or more symptoms: headache, dizziness, general feeling of weakness, drowsiness, confusion, pallor, irritability, trembling, sweating, rapid heartbeat & a cold, clammy feeling.
Mild–to-moderate hypoglycemia: SMBG ≥ 36 mg/dL but <70 mg/dL
Severe hypoglycemia: assistance of another party is required & either:
SMBG of <36 mg/dL, or
with prompt response to treatment with oral carbohydrates, IV glucose or glucagon.
Serious hypoglycemia:
Hypoglycemia with coma/loss of consciousness Or Hypoglycemia seizure/convulsion."|60 weeks from Baseline|Safety Population||Participants|||Number
717818|NCT00283049|Secondary|Change From Baseline to End of Study and to Individual Time Points in Components of Lipid Profile (Total Cholesterol, High-density Lipoprotein Cholesterol [HDL], Low-density Lipoprotein Cholesterol [LDL], Triglycerides, LDL Subfractions)||60 weeks from Baseline|The study was terminated prematurely due to technical issues with electronic diary data. Consequently, some of the initially planned efficacy analyses, based directly or indirectly on the e-diary data, were not performed.||mg/dL||Standard Deviation|Mean
717819|NCT00283049|Secondary|Change From Baseline to Study Time Points in 7-point Blood Glucose (BG) Profile (Before Meals, 2 Hours After Meals, at Bedtime)||60 weeks from Baseline|The study was terminated prematurely due to technical issues with electronic diary data. Consequently, some of the initially planned efficacy analyses, based directly or indirectly on the e-diary data, were not performed.||Percentage||Standard Deviation|Mean
717820|NCT00283049|Secondary|Percentage of Subjects Achieving an HbA1C Less Than (<) 7.0% and Less Than (<) 6.5%||60 weeks from Baseline|The study was terminated prematurely due to technical issues with electronic diary data. Consequently, some of the initially planned efficacy analyses, based directly or indirectly on the e-diary data, were not performed.||Percent||Standard Deviation|Mean
717821|NCT00283049|Secondary|Change From Baseline to Individual Time Points in HbA1c, Insulin Doses, and Total Insulin Dosage||60 weeks from Baseline|The study was terminated prematurely due to technical issues with electronic diary data. Consequently, some of the initially planned efficacy analyses, based directly or indirectly on the e-diary data, were not performed.||Percentage|||Number
717822|NCT00283049|Primary|Change in Hemoglobin A1c (HbA1c) From Baseline to Week 12||12 weeks from Baseline|Safety Population (excluding patients from Good Clinical Practice [GCP] non-compliant sites)||Percentage||Standard Deviation|Mean
717849|NCT00283595|Secondary|IGF-1 Level|Change in IGF-1 level between baseline and 12 weeks|Baseline, 12 Weeks|The analysis group consisted of individuals who completed study visits after the baseline visit. The three subjects who did not continue in the study discontinued their participation after the baseline visit.||ng/ml||Inter-Quartile Range|Median
717823|NCT00283062|Secondary|Assessment of Safety and Tolerability - Number of Participants With Adverse Events (AE)|Number of participants with treatment-emergent adverse events (TEAE). A TEAE was as any adverse event that occurred or worsened during the on-treatment period, which was the period from the day of first infusion of study treatment until 30 days after the last infusion of study treatment.|from treatment initiation up to 19 months after treatment initiation|Safety population: all randomized participants who received any study drug||participants|||Number
717824|NCT00283062|Secondary|To Evaluate Quality of Life (QoL) as Measured Using a Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire|"The FACT-P is a 39-item participant questionnaire which assesses physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and additional prostate cancer specific concerns (12 items). All items are scored from 0 (not at all) to 4 (very much). The total FACT-P score ranges from 0-156, with higher scores representing a better QoL with fewer symptoms. A score of 156 represents the best outcome.
Note: Enrollment was not met, and meaningful conclusions for efficacy or QoL could not be drawn due to the low sample size."|from 30 days before randomization (baseline) and 18 months after treatment initiation (for change from baseline)|QoL population: The subset of randomized participants who had an evaluable baseline questionnaire and at least one evaluable post-baseline questionnaire. A baseline QoL questionnaire was considered evaluable if it was filled out within 30 days prior to randomization, and no later than the date of randomization.||score on a scale||Standard Deviation|Mean
717825|NCT00283062|Secondary|Median Metastasis-free Survival (MFS)|"MFS was the interval from the date of surgery to the date of the first clinical evidence of metastasis after treatment initiation. Metastasis was evaluated by a physical exam or radiologically on bone scan or CT scan. Local (palpable) progression, documented histologically or by imaging techniques was considered evidence of progression.
Median MFS was to be estimated using Kaplan-Meier curves. However, enrollment was not met, and meaningful conclusions for efficacy or QoL could not be drawn. Therefore, based on a protocol amendment, median MFS was not estimated."|from the date of surgery up to 3 years after randomization of the last participant|Based on a protocol amendment, analysis for Median MFS was not to be performed as the study was underpowered.||participants|||Number
717826|NCT00283062|Secondary|Median Cancer-specific Survival (CSS)|"The CSS was the time from the date of surgery to the date of death due to prostate cancer.
Median CSS was to be estimated using Kaplan-Meier curves. However, enrollment was not met, and meaningful conclusions for efficacy or QoL could not be drawn. Therefore, based on a protocol amendment, median CSS was not estimated."|from the date of surgery up to 3 years after randomization of the last participant|Based on a protocol amendment, analysis for Median CSS was not to be performed as the study was underpowered.||participants|||Number
717827|NCT00283062|Secondary|Median Overall Survival (OS)|"Overall survival (OS) was the time interval from the date of surgery to the date of death due to any cause.
Median OS was to be estimated using Kaplan-Meier Curves. However, enrollment was not met, and meaningful conclusions for efficacy or QoL could not be drawn. Moreover, median OS could not be estimated. Reported is the number of participants who died from any cause."|from the date of surgery up to 3 years after randomization of the last participant|Intent-to-treat (ITT) population: all randomized participants, regardless of whether or not they received any drug.||participants|||Number
717828|NCT00283062|Primary|Progression-free Survival (PFS) Assessment - Number of Participants With Disease Progression|"PFS is the interval from the date of surgery to date of progression. The date of progression was the earlier of
first PSA increase to ≥ 0.4 ng/mL confirmed within two weeks
date of the nadir, if PSA nadir did not reach < 0.4 ng/mL (for deferred arm)
first radiological/ histological evidence of tumor progression
death. Median PFS was to be estimated using Kaplan-Meier curves. However, enrollment was not met, and meaningful conclusions for efficacy or QoL could not be drawn. Median PFS could not be estimated. Reported is the number of participants with disease progression."|from the date of surgery up to 3 years after randomization of the last participant|Intent-to-treat (ITT) population: all randomized participants, regardless of whether or not they received any study drug.||participants|||Number
717829|NCT00283075|Primary|Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)|"Dose limiting toxicity (DLT) was defined as:
any Grade 2 allergic reaction of generalized urticaria or any other Grade ≥ 3 allergic reaction;
any Grade ≥ 3 infection and
any Grade ≥ 3 local (intraperitoneal) reaction and any Grade ≥ 3 hematologic or non- hematologic reaction.
This definition of DLT is in accord with the NCI CTCAE v3.0."|6 months|||Participants who observed DLT|||Number
717830|NCT00283075|Other Pre-specified|Tumor Marker Response|Tumor marker response after the first implantation with RENCA macrobeads. Responders showed at least a 20% decrease from baseline in Cancer Antigen 19-9 (CA19-9) or Carcinoembryonic Antigen (CEA); Non-responders do not show at least a 20% decrease from baseline in CA19-9 or CEA.|Prior to Implantation and Day 7, Day 14, Day 21 and Day 28 after each implantation|All participants who had at least one implantation of RENCA macrobeads, either at 8 macrobeads/kg body weight or 16 macrobeads/kg body weight.||participants|||Number
717831|NCT00283075|Secondary|Overall Survival|Overall Survival (OS) was measured as date of first implantation to date of death of any cause, and was analyzed using the Kaplan-Meier method.|From date of RENCA macrobeads implantation until date of death from any cause|||months||95% Confidence Interval|Median
717832|NCT00283075|Primary|Maximum Tolerated Dose (MTD) of RENCA Macrobeads|"Dose limiting toxicity (DLT) was defined as:
any Grade 2 allergic reaction of generalized urticaria or any other Grade ≥ 3 allergic reaction;
any Grade ≥ 3 infection and
any Grade ≥ 3 local (intraperitoneal) reaction and any Grade ≥ 3 hematologic or non- hematologic reaction.
This definition of DLT is in accord with the NCI CTCAE v3.0.
Maximum tolerated dose (MTD) was to be identified if, within a cohort, > 1 subject out of the first 3, or 2 subjects out of 5 experienced DLT. In such a case, the MTD will have been exceeded, and the administration of the study agent was to cease. MTD would not be considered to have been reached if no DLTs were observed."|6 months|||RENCA Macrobeads/kg|||Number
717847|NCT00283439|Secondary|Percentage of Subjects Experiencing Grade 3 or 4 Thrombocytopenia|Percentage of subjects experiencing grade 3 and/or 4 thrombocytopenia (<50 x 10^9/L, and <25 x 10^9/L)|32 weeks|Efficacy Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim, completed the first treatment cycle, and were not replaced per the protocol.||Percentage of participants|||Number
718717|NCT00289211|Secondary|Time to Complete Resolution of the HAE Attack|Randomized subjects were contacted 72-96 hours (3-4 days) after discharge from the study site to determine when complete resolution of the HAE attack occurred.|72 hours|ITT Population.||hours||95% Confidence Interval|Median
717833|NCT00283244|Secondary|Quality of Life (QOL)- Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) Trial Outcome Index-L (TOI-L)|"The FACT-L is the FACT-G and a lung cancer specific (LCS) subscale given at baseline, after each cycle and at end of treatment. The FACT-G is a 27 item measure of general QOL assessing function in 4 domains: physical well-being (PWB), social-family well-being (SFWB), emotional well-being (EWB) and functional well-being (FWB). Items are rated by patients on a Likert scale from 0 to 4. Higher scores represent better QOL. The TOI-L sums the PWB, FWB, and LCS subscale scores.
A best response for TOI-L scores is based on change from baseline and coded as:
a change >=+6 “improved”, <= -6 “worsened” and otherwise “no change”.
A best overall score response is coded as:
Improved (2 visit resp. of “improved” a min. of 28 days apart w/ no interim “worsened”) No change (not “improved;” 2 visit resp. of “no change” or “improved” a min. of 28 days apart w/ no interim “worsened”) Worsened (not “improved” or “no change;” 2 consecutive “worsened”) Other (none of the above)"|After each cycle/3 weeks|||participants|||Number
717834|NCT00283244|Secondary|Toxicity|Assessments for treatment toxicity will be done with each cycle according to CTCAE v3. Results listed here are grade >=3, treatment related hematologic events (all) and Grade>=3 treatment related non hematologic events that occurred in >=5% of patients in any arm. Adverse events (toxicities) are graded on a 5 point scale from 1 (mild) to 5 (lethal), with grades 3 and higher being severe or life threatening.|After each cycle/3 weeks, up to 3 years|||participants|||Number
717835|NCT00283244|Secondary|Overall Survival|Survival calculated from start of treatment to death from any cause for up to three years.|Up to 3 years|||Months||95% Confidence Interval|Median
717836|NCT00283244|Secondary|Response Rate|The best overall response (BOR) is the best response recorded from the start of the treatment until disease progression-recurrence (taking as reference for progressive disease the smallest measurement recorded since the treatment started. The response rate was defined as the percentage of patients achieving a BOR of complete response or partial response. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Six months|||percentage of participants|||Number
717837|NCT00283244|Primary|Progression-free Survival|We would consider the combination of gemcitabine plus erlotinib or single agent erlotinib to be worthy of further study if there was an increased progressed-free survival. We would use an increase to 45% progression-free survival at 6 months as significant. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Six months|||months||95% Confidence Interval|Median
717838|NCT00283296|Primary|Average Distance Traveled Per/Day During the 2 Week Time Period (Endeavor w/c)|Mean distance traveled per/day using the Endeavor w/c was recorded with use of customized datalogger.|2 week in-home trial|Endeavor w/c||meters/day||Standard Deviation|Mean
717839|NCT00283296|Primary|Average Distance Traveled Per/Day During the 2 Week Time Period (Personal w/c)|Mean distance traveled per/day using the personal w/c was recorded with use of customized datalogger.|2 week in-home trial|personal w/c||meters/day||Standard Deviation|Mean
717840|NCT00283296|Primary|Number of Participants Reported the Endeavor to be the Same as Their Current w/c or Better With Regards to Transporting in a Vehicle|Participants completed an Activities of Daily Living Course in their own personal w/c and the Endeavor. Then participants were asked to rate their level of difficulty to complete based on a 5 point likert scale: very difficult, difficult, moderate, easy, very easy. Number of participants reported the Endeavor w/c to be the same as their current w/c or better with regards to transporting in a vehicle.|immediately following course completion|||participants|||Number
717841|NCT00283387|Primary|Urinary Oxalate Excretion|"The patients were randomly assigned oral betaine or placebo for 2 months, followed by a 2 month washout. Each patient then received the alternate study medication for 2 months.
Urinary Oxalate Excretion was measured by oxalate oxidase. Two 24 hour urine collections were obtained at baseline, and during the eighth week of each study period."|baseline, 2 months, 6 months|Per protocol analysis: 10 of 15 enrolled PHI subjects completed the study: 2 withdrew before initiation, 2 were noncompliant, in 1 symptoms led to withdrawal.||umol/mg||Standard Deviation|Mean
717842|NCT00283400|Secondary|Good Clinical Outcome Was Defined as a Glasgow Outcome Scale Score of 0-1|Number of subjects with good clinical outcome defined as a Glasgw Outcome Scale score of 0-1|3 months after enrollment|||participants|||Number
717843|NCT00283400|Secondary|Serious Adverse Events|"Serious adverse events included neurological and medical complications and neurological deterioration.
Neurological deterioration was defined as a decline by more than 2 points in the Glasgow Coma Scale."|within 3 months after enrollment|||participants|||Number
717844|NCT00283400|Primary|Safety and Tolerability of the 25% Human Albumin Dosages and the Functional Outcome.|Tolerability outcome: Subject's ability to receive the full allocated human albumin dose without incurring frank congestive heart failure or experiencing anaphylactic reactions that required discontinuation of the treatment. Study would be terminated if 2 or more subjects developed severe or life-threatening heart failure considered to be related (probably, possibly, and definitely) to albumin treatment.|9 days after enrollment|Sample size consideration for this Phase I dose-escalation study was based on the feasibility of recruiting patients in a 3-year study period at 5 sites.The recruitment yield would be a maximum of 80 patients or 20 patients per dosage group. Statistical analyses were mainly descriptive.||participants|||Number
717845|NCT00283439|Secondary|Percentage of Subjects That Received Platelet Transfusions|Percentage of subjects that received platelet transfusions during the first romiplostim treatment cycle|32 weeks|Efficacy Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim, completed the first treatment cycle, and were not replaced per the protocol.||Percentage of participants|||Number
717846|NCT00283439|Secondary|Duration of Grade 3 or 4 Thrombocytopenia|Duration of grade 3 and/or 4 thrombocytopenia (<50 x 10^9/L and <25 x 10^9/L, respectively)|32 weeks|Efficacy Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim, completed the first treatment cycle, and were not replaced per the protocol.||Day||Standard Error|Mean
719151|NCT00294645|Secondary|Percentage of Participants With First Diagnosis of Loss of Atrial Capture at 12 Months|Compare time to first diagnosis in Control and Remote arms|One year post-enrollment|Analysis used subset of full cohort excluding participants with single chamber devices, thus the variance in number analyzed.||Percentage of participants|||Number
717850|NCT00283595|Primary|Bone Metabolism|Change in the marker of bone formation, N-terminal pro peptide of type 1 procollagen (P1NP) levels, between baseline and 12 weeks|Baseline, 12 weeks|Only subjects who completed study visits after the baseline visit were included in the analysis. The three subjects who discontinued the study only completed a baseline visit and were therefore not included in the analysis.||ng/ml||Standard Error|Mean
717851|NCT00283686|Secondary|Quality of Life Mental Component Summary|Short Form-36 Quality of LIfe Mental Component Summary ranges from 0 (worst possible outcome) to 100 (best possible outcome)|baseline, 12, 24, 36, 48, 60, 72, 84, and 96 months (assessed annually)|Analysis using intention to treat.||annual change in units on a scale||95% Confidence Interval|Mean
717852|NCT00283686|Secondary|Quality of Life Physical Component Summary|Short Form-36 Quality of Life Physical Component Summary ranges from 0 (worst possible outcome) to 100 (best possible outcome)|baseline, 12, 24, 36, 48, 60, 72, 84, and 96 months (assessed annually)|Analysis using intention to treat||annual change in units on a scale||95% Confidence Interval|Mean
717853|NCT00283686|Secondary|All-Cause Hospitalizations||Up to 96 months|Intention to treat analysis: All participants who were randomized.||events|||Number
717854|NCT00283686|Secondary|Renal Blood Flow|renal blood flow (mL/min/1.73 m^2) from MRI, centrally reviewed and measured. This outcome was more difficult to measure resulting in more missing data than other MRI outcomes such as total kidney volume (TKV) and left ventricular mass index (LVMI).|0, 24 months, 48 months, 60 months|Analyses were conducted using intention to treat analyses for participants with at least one valid renal blood flow measure.||annual change in mL/min/1.73 m^2||95% Confidence Interval|Mean
717855|NCT00283686|Secondary|Left Ventricular Mass Index|Left ventricular mass index (g/m^2) measured by MRI, centrally reviewed and measured|0, 24 months, 48 months, 60 months|Analyses were conducted using intention to treat for participants with at least one left ventricular mass index measure.||annual change in g/m^2||95% Confidence Interval|Mean
717856|NCT00283686|Secondary|Aldosterone|Urinary aldosterone excretion, centrally processed, 24 hour urine collection|Up to 96 months (assessed annually)|Analysis using intention to treat||annual % change micrograms per 24 hr||95% Confidence Interval|Mean
717857|NCT00283686|Secondary|Albuminuria|Urine albumin excretion, centrally processed from 24 hour urine collection|Up to 96 months (assessed annually)|Analysis by intention to treat||annual percent change in mg/24 hr||95% Confidence Interval|Mean
717858|NCT00283686|Secondary|Kidney Function (eGFR)|The estimated GFR was calculated by means of the Chronic Kidney Disease Epidemiology Collaboration equation with the use of central serum creatinine measurements.|Up to 96 months (6 month assessments)|Analyses were intention to treat: All participants who were randomized.||ml/min/1.73/m2/yr||95% Confidence Interval|Mean
717859|NCT00283686|Primary|Study A: Percent Annual Change in Total Kidney Volume|Annual percentage change in total kidney volume as assessed by abdominal magnetic resonance imaging (MRI) at baseline, 2 years, 4 years, and 5 years follow-up.|Baseline and 2-, 4- and 5-year follow-up|Analyses were conducted on all participants who had at least one total kidney volume measurement using intention to treat.||percentage of Total Kidney Volume||95% Confidence Interval|Mean
717860|NCT00283712|Secondary|Participant Pemphigus Vulgaris Disease Activity Score|The Pemphigus Vulgaris Disease Activity (PVDA) score was used to grade a participant’s disease activity using the SAGE II computerized burn mapping system, which calculated the total body surface area (BSA) involved. Scores were based on the number of new lesions and blisters present, old lesion history and BSA involved. Scores range from 0 to 3 (none to severe disease activity). A new disease activity score of 3 or an old lesion score of 3 indicates active disease. New disease activity scores of 3 for a 1-month duration or an old lesion score of 3 for 2 consecutive months was cause for removal from the study treatment|Baseline to Week 26|Safety Population||Participants|||Number
717861|NCT00283712|Secondary|Adverse Events Resulting in Treatment Discontinuation|Adverse events experienced by participants resulting in study treatment discontinuation and assessed by the investigators as at least possibly related to treatment (i.e., possibly, probably, definitely) were assessed.|Baseline to Week 26|Safety Population||Participants|||Number
717862|NCT00283712|Secondary|Participants Who Experienced Severe Infectious Complications|Serious and life-threatening infections of Grade 3 or greater based on the National Cancer Institute (NCI), Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 3.0 were assessed.|Baseline to Week 26|Safety Population||Participants|||Number
717863|NCT00283712|Secondary|Participants Who Experienced Severe Infusion Reactions|Participants who experienced severe infusion reactions of Grade 3 or greater based on the National Cancer Institute (NCI), Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 3.0 were assessed.|Baseline to Week 26|Safety Population||Participants|||Number
717864|NCT00283712|Secondary|Participant Duration of Clinical Response|The primary efficacy endpoint of response to treatment at Week 18 was reassessed at study weeks 22 and 26 for participants who were responders at Week 18. Participants classified as responders had: 1. Achieved a prednisone dosage <= 25% of the initial starting dose or <= 10 mg/day (whichever is greater), and 2. had no new blisters within the previous 4 weeks.|Baseline to Week 26|Participants in the Intent-to-Treat Population Who Were Responders at Week 18||Participants|||Number
717865|NCT00283712|Secondary|Participant Dermatology-Related Quality of Life Changes From Baseline to Week 18|The Dermatology Life Quality Index (DLQI) is a 10-question questionnaire with a weighted value to each question. The DLQI score was calculated by summing the score of each question, resulting in a maximum score of 30 and a minimum score of 0. The higher the score, the greater quality of life is impaired. Change from baseline values (defined as the visit value - baseline value) were calculated. A negative change indicates better quality of life; a positive change indicates poorer quality of life.|Baseline to Week 18|Intent-to-Treat with available data||units on a scale||Standard Deviation|Mean
717866|NCT00283712|Secondary|Participant Health Related Quality of Life (Medical Outcome Study Short Form 36) Score Changes From Baseline to Week 18|The Medical Outcome Study Short Form 36 (MOS SF-36) measures health -related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from baseline is computed as the value at Week 18 minus the baseline value. A positive value in change from Baseline indicates an improvement and a negative value worsening.|Baseline to Week 18|Intent-to-Treat with available data||units on a scale||Standard Deviation|Mean
717867|NCT00283712|Secondary|Total Prednisone Dosage Required for Participants to Achieve 80% Healing of Existing Erosions|Each participant’s prednisone dose was summed from the time of enrollment until the date of 80% healing of existing erosions. Actual prednisone use per day was computed as the average over all days in the week.|Baseline to Week 26|Subset of Intent-to-Treat Who Experienced Erosion Healing||mg||Standard Deviation|Mean
717868|NCT00283712|Secondary|Total Prednisone Dosage Required for Participants to Achieve Cessation of New Blisters|Each participant’s prednisone dose was summed from the time of enrollment until the date of cessation of new blisters. Actual prednisone use per day was computed as the average over all days in the week.|Baseline to Week 26|Subset of Intent-to-Treat Who Experienced Lesion Cessation||mg||Standard Deviation|Mean
717869|NCT00283712|Secondary|Time to 80% Lesion Healing|Time to 80% healing of existing erosions/ulcerations at time of enrollment was assessed using the SAGE II computerized burn-mapping system. The date of 80% healing of existing erosions/ulcerations at time of enrollment was defined as follows: the first date at which the percent of total body surface area (BSA) involved is at least 80% less than the percent of total BSA calculated at the time of enrollment, where the baseline percent of total BSA must be greater than zero percent. If a participant had missing post-baseline assessments, their data was censored at their last non-missing assessment date.|Baseline to Week 26|Subset of Intent-to-Treat Who Experienced Lesion Healing||Days||Standard Deviation|Mean
717870|NCT00283712|Secondary|Participant Time to Cessation of New Blisters|Time to cessation of new blisters was defined as the time from a participant's first treatment infusion date to the first date where that date and all subsequent dates had no new blisters. Participant diaries were used to assess new blister formation. To achieve cessation, participants had to be free of new blisters at least 3 weeks prior to their last assessment. In order to analyze missing or incomplete data, the data was censored at the date where a participant had no more data or on the date where 50% of the participant’s data was missing past that point.|Baseline to Week 26|Subset of Intent-to-Treat Who Experienced Cessation||Days||Standard Deviation|Mean
717871|NCT00283712|Secondary|Participant Modified Response Status at Week 18|Modified responder status was defined as participants achieving a prednisone dosage <=25% of the initial starting dose or <=10 mg/day (whichever is greater) at Week 18 regardless of status on new blister formation during the previous 4 weeks.|Baseline to Week 18|Intent-to-Treat||Participants|||Number
717872|NCT00283712|Secondary|Participant Response to Treatment at Week 18|Participants classified as responders at Week 18 had: 1. Achieved a prednisone dosage <= 25% of the initial starting dose or <=10 mg/day (whichever is greater), and 2. Had no new blisters within the previous 4 weeks.|Baseline to Week 18|Per-protocol||Participants|||Number
717873|NCT00283712|Primary|Treatment-Related Adverse Events >= Grade 3 On or Before Week 18|Grades were based on the National Cancer Institute (NCI), Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 3.0. An adverse event (AE) was considered treatment-related if it was classified as unlikely, possibly, probably, or definitely related to study treatment. Participants who experienced at least one treatment-related, grade 3 or higher AE were counted only once. AEs of skin including rash, skin ulceration, and chelitis as defined by the NCI-CTCAE V3.0 System Organ Class of “Skin and Subcutaneous Tissues Disorders” were excluded.|Baseline to Week 18|Safety Population||Participants|||Number
717874|NCT00283712|Primary|Participant Response to Treatment at Week 18|Participants classified as responders at Week 18 had: 1. Achieved a prednisone dosage <= 25% of the initial starting dose or <= 10 mg/day (whichever is greater), and 2. Had no new blisters within the previous 4 weeks.|Baseline to Week 18|Intent-to-Treat||Participants|||Number
717875|NCT00283816|Secondary|Change in Sex Hormone Binding Globulin (SHBG)|SHBG concentration post minus pre-intervention|baseline and 24 weeks|||nmol/L||Standard Deviation|Mean
717876|NCT00283816|Secondary|Total Testosterone Change|Change in total testosterone post minus pre intervention|baseline and 24 weeks|||ng/dL||Standard Deviation|Mean
717877|NCT00283816|Secondary|Change in Weight Post Minus Pre Intervention.|Body mass index change in adolescents enrolled in lifestyle intervention program|baseline and 24 weeks|||kg/m^2||Standard Deviation|Mean
717878|NCT00283816|Primary|Reduction in Abdominal Fat as Measured by Waist Circumference.|Change in waist circumference measured in cms used as a measure of abdominal adiposity, pre minus post intervention|baseline and 24 weeks|||cm||Standard Deviation|Mean
717879|NCT00283842|Secondary|Number of Patients With ≥50% Reduction in Mean Pain Severity Score.|Pain severity measured on a Numeric Rating Scale (NRS). Range: 0 (no pain) to 10 (worst possible pain). Assessment of reduction based on change in score at 13 weeks compared to baseline.|Baseline and 13 weeks|The analysis population is the intent to treat.||patients|||Number
717880|NCT00283842|Primary|Change in Mean Pain Severity Score From Baseline to 13 Weeks|Pain severity measured on a Numeric Rating Scale (NRS). Range: 0 (no pain) to 10 (worst possible pain). Change: score at 13 weeks minus score at baseline.|Baseline and 13 weeks|The analysis population was the intent to treat.||units on scale||Standard Error|Mean
717881|NCT00283868|Secondary|Percentage of Evaluations With Technical Observations|Technical Observations: This measure was designed to assess the percentage of evaluations where there were technical observations (difficulties with using the technology) noted by the consultant who performed the evaluation (either telemedicine evaluation or telephone evaluation) in each arm of the trial.|Time of consultation|||Percentage of Evaluations|||Number
717882|NCT00283868|Secondary|Time to Treatment Decision for Administration of Thrombolytics|time to decision (consult onset to decision). This measure was meant to assess how long it took to do the evaluation.|potentially within 3 hours of symptom onset|||Minutes||Standard Deviation|Mean
717883|NCT00283868|Secondary|Percentage of Total Thrombolytic Administrations|This measure assesses the number of total thrombolytic administrations that were given. This was to measure whether there were more participants treated with thrombolytics in one arm of the trial or the other.|potentially within 3 hours of symptom onset|||Percentage of participants|||Number
717884|NCT00283868|Secondary|Percentage of Participants With Intracerebral Hemorrhage (ICH)|Intracerebral Hemorrhage (ICH) rate at 36 hours. This was assessed by determining whether there was an intracerebral hemmorhage via telephone contact to the hospital where the patient was located. Any follow up imaging (head CT or MRI) was reported to the investigator team for presence of hemorrhage.|36 hours|||Percentage of participants|||Number
719152|NCT00294645|Secondary|Percentage of Participants With First Diagnosis of Non-sustained Ventricular Tachycardia at 12 Months|Compare time to first diagnosis in Control and Remote arms|One year post-enrollment|||Percentage of participants|||Number
717885|NCT00283868|Primary|Appropriateness of Decision to Treat or Not Treat With Thrombolytics|"This primary measure assesses the appropriateness of decision to treat or not treat with thrombolytics for patients presenting potentially within 3 hours of symptom onset.
Appropriateness was assessed using a centralized adjudicating committee, 3 levels of data availability, and an independent medical monitor assessment. The case was presented to the adjudicating committee (blinded to randomization arm) and the committee reviewed patient records (also blinded to randomization arm) to assess whether decision was appropriate to give or not give rt-PA."|potentially within 3 hours of symptom onset|Of the original 234 patients, 11 were run in patients and were not randomized and 1 was removed from any analysis due to a protocol violation resulting in the total 222 patients analyzed. There were 7 lost to follow up in telemedicine and 8 lost to follow up in telephone resulting in 104 analyzed in telemedicine and 103 analyzed in telephone.||percentage of participants|||Number
717886|NCT00284050|Secondary|Mean Change From Baseline in Central Retinal Thickness (µm) of the Study Eye at Month 12|Optical Coherence Tomography (OCT) was assessed on both eyes at every study visit. These assessments were performed by trained personnel at the sites. OCT imaging was performed using the Zeiss Humphrey System Model 2000 (or later) with version A6.1 software running under Windows 95 or Windows 98. The analysis of the OCT images were performed by the Photographic Reading Center which provided a study manual and training materials. OCT operators, systems and software were certified prior to any evaluation of study patients.|Baseline through the end of study (Month 12)|Full Analysis Set (FAS): All patients who received at least one application of study treatment and had at least one post-baseline assessment for BCVA. A Last Observation Carried Forward (LOCF) approach was used; missing values were replaced by the mean of the last observation before and the first observation after the missing time-point.||µm||Standard Deviation|Mean
717887|NCT00284050|Primary|Mean Change From Baseline in Visual Acuity (Letters) of the Study Eye at Month 12|Visual acuity (VA) was assessed on both eyes during every study visit using best correction determined from protocol refraction. VA measurements were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters as described in the Study Operations Manual.|Baseline through the end of study (Month 12)|Full Analysis Set (FAS): All patients who received at least one application of study treatment and had at least one post-baseline assessment for BCVA. A Last Observation Carried Forward (LOCF) approach was used; missing values were replaced by the mean of the last observation before and the first observation after the missing time-point.||Letters||Standard Deviation|Mean
717888|NCT00284050|Primary|Difference Between the Baseline Level of Visual Acuity (Letters) of the Study Eye and the Mean Visual Acuity Averaged Over All Monthly Post-baseline Assessments From Month 1 to Month 12|Visual acuity (VA) was assessed on both eyes during every study visit using best correction determined from protocol refraction. VA measurements were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters as described in the Study Operations Manual.|Baseline through the end of study (Month 12)|Full Analysis Set (FAS): All patients who received at least one application of study treatment and had at least one post-baseline assessment for BCVA. A Last Observation Carried Forward (LOCF) approach was used; missing values were replaced by the mean of the last observation before and the first observation after the missing time-point.||Letters||Standard Deviation|Mean
717889|NCT00284089|Secondary|Mean Change From Baseline in Total Retinal Volume of the Study Eye in Group B|Total retinal volume was assessed by Optical Coherence tomography (OCT) at a subset of the study sites and was analyzed by the central reading center.|Baseline, Months 3, 6, 9 and 12|OCT was performed in a total of 58 patients at selected sites. Group B Intent-to treat (ITT) population, observed data only are included. The assessed sample size was small for total retinal volume data because the central reading center judged “Can not grade” due to retinal pigment epithelium disruption associated with CNV secondary to AMD.||micrometers||Standard Deviation|Mean
717890|NCT00284089|Secondary|Mean Change From Baseline in Foveal Retinal Thickness of the Study Eye in Group B|Foveal retinal thickness was assessed by Optical Coherence Tomography (OCT) at a subset of the study sites and was analyzed by the central reading center.|Baseline, Months 3, 6, 9 and 12|The analysis includes Group B Intent-to treat (ITT) population, observed data. OCT was performed in a total of 58 patients at selected sites.||micrometers||Standard Deviation|Mean
717891|NCT00284089|Secondary|Percentage of Participants in Group B With Absence of Leakage in the Study Eye at Month 3, 6, 9 and 12.|Area of leakage was assessed by fluorescein angiography in conjunction with color fundus photography. Analysis was performed at the central reading center.|Months 3, 6, 9 and 12|Intent-to treat (ITT) population for Group B patients consisted of all patients randomized in Group B that received at least one dose of study drug and for whom data was available. The Last Observation Carried Forward (LOCF) was used to impute missing data.||Percentage of participants|||Number
717892|NCT00284089|Secondary|Mean Change From Baseline in Total Area of Leakage From CNV Plus Staining of Retinal Pigment Epithelium of the Study Eye in Group B|Area of leakage from CNV plus staining of retinal pigment epithelium was assessed by fluorescein angiography in conjunction with color fundus photography. Analysis was performed by the central reading center. The total area is expressed as Macular Photocoagulation Study standard Disc Areas (DA; equivalent to 2.54 mm^2 on the retina).|Baseline, Months 3, 6, 9 and 12|Intent-to treat (ITT) population for Group B patients consisted of all patients randomized in Group B that received at least one dose of study drug and had at least one post-baseline assessment. The Last Observation Carried Forward (LOCF) was used to impute missing data.||disc areas||Standard Deviation|Mean
717893|NCT00284089|Secondary|Mean Change From Baseline in Total Area of Choroidal Neovascularization of the Study Eye in Group B|Choroidal Neovascularization was assessed by fluorescein angiography in conjunction with color fundus photography. Analysis was performed by the central reading center. The area of Choroidal Neovascularization is expressed as Macular Photocoagulation Study standard Disc Areas (DA; equivalent to 2.54 mm^2 on the retina).|Baseline, Months 3, 6, 9 and 12|Intent-to treat (ITT) population for Group B patients consisted of all patients randomized in Group B that received at least one dose of study drug and had at least one post-baseline assessment. The Last Observation Carried Forward (LOCF) was used to impute missing data.||disc areas||Standard Deviation|Mean
719153|NCT00294645|Secondary|Percentage of Participants With First Diagnosis of Ventricular Pacing Increase Greater Than 30 Percent at 12 Months|Compare time to first diagnosis in Control and Remote arms|One year post-enrollment|||Percentage of participants|||Number
717894|NCT00284089|Secondary|Extension Phase: Categorical Analysis of Best Corrected Visual Acuity of the Study Eye at Last Visit of Extension Phase in Group B|"BCVA measurements were taken in a sitting position using best correction determined from protocol refraction and ETDRS-like visual acuity testing charts at a starting test distance of 2 meters. The following categories were evaluated:
Participants with a BCVA score loss of fewer than 15 letters from baseline at Last Visit
Participants with a BCVA score loss of 30 or more letters from baseline at Last Visit
Participants with a BCVA score gain of 15 or more letters from baseline at Last Visit
Participants with a BCVA score of less than 34 letters at Last Visit"|Baseline and last visit of extension phase - Duration in the extension phase varied depending on the study entry. The mean duration of treatment was 1.45 years in the 0.3 mg group and 1.36 years in the 0.5 mg dose group.|Includes patients enrolled in the extension phase, observed data.||Participants|||Number
717895|NCT00284089|Secondary|Extension Phase: Mean Change From Month 12 (Start of Extension Phase) in Best Corrected Visual Acuity Score of the Study Eye at Last Visit of Extension Phase in Group B.|Best Corrected Visual Acuity (BCVA) was assessed during all study visits using best correction determined from protocol refraction at a starting test distance of 2 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a starting test distance of 2 meters. The BCVA score is the number of letters read correctly by the patient, hence an increase in score indicates improvement in acuity.|Month 12 (start of extension phase) and last visit of extension phase. Duration in the extension phase varied depending on the study entry. The mean duration of treatment was 1.45 years in the 0.3 mg group and 1.36 years in the 0.5 mg dose group.|The analysis population included all enrolled patients in the extension phase. For the analysis of the results of the extension phase, all data are presented as observed. Patients must have values both at Month 12 and Last Visit to be included.||Letters||Standard Deviation|Mean
717896|NCT00284089|Secondary|Categorical Analysis of Best Corrected Visual Acuity of the Study Eye at Month 6 and Month 12 in Group B|BCVA measurements were taken in a sitting position using best correction determined from protocol refraction and ETDRS-like visual acuity testing charts at a starting test distance of 2 meters.|Baseline, Month 6 and Month 12|ITT population, using LOCF.||Participants|||Number
717897|NCT00284089|Secondary|Mean Change From Baseline in the Best Corrected Visual Acuity Score of the Study Eye at Month 12 in Group B|The efficacy assessment was based on Group B patients. BCVA was assessed during all study visits using best correction determined from protocol refraction and ETDRS-like visual acuity testing charts at a starting test distance of 2 meters. The BCVA score is the number of letters read correctly by the patient, hence an increase in score indicates improvement in acuity.|Baseline and Month 12|Intent-to treat (ITT) population for Group B patients consisted of all patients randomized in Group B that received at least one dose of study drug and had at least one post-baseline assessment of the efficacy variable. The Last Observation carried Forward (LOCF) was used to impute missing data at month 12 in the ITT analysis.||Number of Letters||Standard Deviation|Mean
717898|NCT00284089|Primary|Mean Change From Baseline in the Best Corrected Visual Acuity Score of the Study Eye at Month 6 in Group B|The efficacy assessment was based on Group B patients. Best Corrected Visual Acuity (BCVA) was assessed during all study visits using best correction determined from protocol refraction at a starting test distance of 2 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a starting test distance of 2 meters. The BCVA score is the number of letters read correctly by the patient, hence an increase in score indicates improvement in acuity.|Baseline and Month 6|Intent-to treat (ITT) population for Group B patients consisted of all patients randomized in Group B that received at least one dose of study drug and had at least one post-baseline assessment of the primary efficacy variable. The Last Observation Carried Forward (LOCF) was used to impute missing data at month 6 in the ITT analysis.||Number of Letters||Standard Deviation|Mean
717899|NCT00284141|Secondary|Number of Participants With Anti-drug Antibodies|"Anti-drug antibodies in a participant's serum sample were assayed with an anti-drug ELISA assay, with a lower limit of quantitation of 238.4 ng/mL for an undiluted human serum sample.
Serum for anti-drug antibody analysis was collected pre-dose on every fourth cycle after Cycle 1 Day 1 (at 8 week intervals), at end of treatment (EOT), and during post-treatment follow-up 60 days after the last dose."|up to 2.5 years after initial treatment|All participants who received at least part of 1 dose of study treatment and had evaluable blood samples.||participants|||Number
717900|NCT00284141|Primary|Confirmed Objective Response Based Upon Modified Response Evaluation Criteria in Solid Tumors (RECIST) Assessed by the Investigator.|"OR was either complete response (CR) or partial response (PR) based on RECIST or modified RECIST. CR was the disappearance of all target/nor-target lesions; and PR was at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, with reference to the baseline sum LD (According to modified RECIST, to calculate LD for cavitated lesions, the longest cavitation diameters were subtracted from the LD of cavitated target lesions).
Assessments were made by the Investigator, and confirmed by repeat tumor imaging 4-6 weeks after documentation of the initial response."|up to 2.5 years from initial treatment|Simon's cohort: The first 84 evaluable participants, based on Simon's two-stage study design that required 84 evaluable participants to maintain a targeted 90% power.||participants|||Number
717901|NCT00284141|Secondary|Free and VEGF-bound Trough Aflibercept Concentrations (VEGF Trap)|"Median free and VEGF-bound trough concentrations were determined at the end of each cycle beyond Cycle 2 (Steady-state) for each participant.
Plasma free aflibercept levels were estimated by a validated direct ELISA, with an LOQ of 15.6 ng/mL. Plasma VEGF-bound aflibercept levels were also estimated by a separate validated direct ELISA with an LOQ of 43.9 ng/mL.
Mean ± SD (coefficient of variation [CV%]) values were estimated from the median values calculated for each participant."|At the end of each treatment cycle (up to 2.5 years)|All participants who received at least part of 1 dose of study treatment and had evaluable blood samples on Day 1 of Cycle 3 for measurement of VEGF-bound aflibercept.||micrograms/mL||Standard Deviation|Mean
717902|NCT00284141|Secondary|Peak of Free Aflibercept (VEGF Trap)|Plasma free aflibercept levels after the first aflibercept infusion were estimated by a validated direct measured by enzyme-linked immunosorbent assay (ELISA), with a limit of quantification (LOQ) of 15.6 ng/mL.|Day 1 of the first infusion of Aflibercept (cycle 1)|All participants who received at least part of 1 dose of study treatment and had evaluable blood samples.||micrograms/mL||Standard Deviation|Mean
719202|NCT00294684|Secondary|Presence of Ascites at 12 Months||12 Months|Participants with their native liver at 12 months||participants|||Number
717903|NCT00284141|Secondary|Number of Participants With Laboratory Abnormalities|"Participants with abnormal laboratory results for
Liver and renal function (Alkaline phosphatase, Alanine aminotransferase [ALT], aspartate aminotransferase [AST], Creatinine, Hyperbilirubinemia),
Electrolytes (Hypercalcemia, Hypocalcemia, Hypokalemia, Hypernatremia, Hyponatremia, Hypophosphatemia)
Metabolism (Hypoalbuminemia, Hyperglycemia, Hypoglycemia)
Hematology (Partial thromboplastin time, Anemia, Lymphopenia, Neutropenia, Thrombocytopenia, Leukopenia)"|Up to 2.5 years|All participants who received at least part of 1 dose of study treatment.||Participants|||Number
717904|NCT00284141|Secondary|Overall Safety - Number of Participants With Adverse Events|All AEs regardless of seriousness or relationship to study treatment, spanning from the first administration of study treatment until 60 days after the last administration of study treatment, were recorded, and followed until resolution or stabilization. The number of participants with all treatment emergent adverse events (TEAE), serious adverse events (SAE), TEAE leading to death, and TEAE leading to permanent treatment discontinuation are reported.|up to 60+/-5 days after treatment discontinuation, or or until TEAE was resolved or stabilized (Collected till 18 July 2008)|All participants who received at least part of 1 dose of study treatment.||participants|||Number
717905|NCT00284141|Secondary|Heath-related Quality of Life (QOL) Measured Via the Lung Cancer Subscale|"HRQL was assessed with the Functional Assessment of Cancer Therapy-Lung Cancer Subscale (FACT-LCS) questionnaire, which was completed by the participants on Day 1 of Cycle 1 only (for baseline value), then on Day 14 of each even-numbered cycle to evaluate the participants symptoms.
The questionnaire scored 7 symptoms: shortness of breath, weight loss, clarity in thinking, coughing, appetite, chest tightness, ease of breathing, on a 0-4 scale. The total FACT-LCS score ranged from 0-28 (where 28 was related to the worst outcome). To calculate a change, the baseline score was subtracted from the score obtained after treatment. A negative value implied an improvement in HRQL."|Baseline to 2.5 years|All registered participants with available questionnaires at the timepoint assessed.||score on a scale||Standard Deviation|Mean
717906|NCT00284141|Secondary|Overall Survival (OS)|"OS was the time interval between registration to the date of death from any cause. The median time for OS was estimated from Kaplan-Meier Plots.
A participant was to be censored for the OS analysis if the participant was alive by the study cut-off date. The censoring date was either the date that the participant was last known to be alive or the date of study cut-off, whichever came earlier."|up to 2.5 years from initial treatment|All registered participants. 38 participants were censored for OS.||months|Participants|95% Confidence Interval|Median
717907|NCT00284141|Secondary|Progression-free Survival (PFS) Time Assessed by the Investigator|"PFS time was interval from the date of registration to the date of tumor progression (by RECIST or modified RECIST), or death from any cause, whichever was earlier. If a participant did not progress or die, the date was censored to the date of last valid tumor assessment or the date of data cut-off, whichever was earlier. Median PFS time was estimated from Kaplan-Meier Plots.
Progression was at least a 20% increase in the sum of the longest diameter (LD) of tumors, compared to smallest sum LD recorded since treatment started, or the appearance of one or more new tumors."|up to 2.5 years from initial treatment|All registered participants. 17 participants were censored.||weeks|Participants|95% Confidence Interval|Median
717908|NCT00284141|Secondary|Progression-free Survival (PFS) Time Assessed by the Independent Review Committee (IRC)|"PFS time was interval from the date of registration to the date of tumor progression (by RECIST or modified RECIST), or death from any cause, whichever was earlier. Median PFS time was estimated from Kaplan-Meier Plots.
Progression was at least a 20% increase in the sum of the longest diameter (LD) of tumors, compared to smallest sum LD recorded since treatment started, or the appearance of one or more new tumors.
If a participant did not progress or die, the date was censored to the date of last valid tumor assessment or the date of data cut-off, whichever was earlier."|up to 2.5 years from initial treatment|All registered participants. 18 participants were censored.||weeks|Participants|95% Confidence Interval|Median
717909|NCT00284141|Secondary|Duration of Response (DR)|DR was the time interval from the first complete response (CR) or partial response (PR) to the date of tumor progression or death from any cause, whichever was earlier. The duration of response was calculated only for those participants who achieved CR or PR.|up to 2.5 years from initial treatment|No modified RECIST responses, as confirmed by the IRC review, were observed. Only 2 responders were reported by the Investigators. Therefore, the analyses for duration of response was not performed.|||||
717910|NCT00284141|Primary|Confirmed Objective Response (OR) Based Upon Modified Response Evaluation Criteria in Solid Tumors (RECIST) Assessed by the Independent Review Committee (IRC).|"OR was either complete response (CR) or partial response (PR) based on RECIST or modified RECIST. CR was the disappearance of all target/nor-target lesions; and PR was at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, with reference to the baseline sum LD (According to modified RECIST, to calculate LD for cavitated lesions, the longest cavitation diameters were subtracted from the LD of cavitated target lesions).
Assessments were made by the IRC, and confirmed by repeat tumor imaging 4-6 weeks after documentation of the initial response."|up to 2.5 years from initial treatment|Simon's cohort: The first 84 evaluable participants, based on Simon's two-stage study design that required 84 evaluable participants to maintain a targeted 90% power.||Participants|||Number
717911|NCT00284154|Secondary|Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease|Progression free survival was defined as the interval between the start date of treatment and the date of occurrence of progressive disease or death.|18 months|All patients were assessed for progression free survival.||Months||95% Confidence Interval|Median
717912|NCT00284154|Secondary|Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death|Overall survival was measured from the date of study entry until the date of death.|18 months|All patients were assessed for overall survival.||Months||95% Confidence Interval|Median
717913|NCT00284154|Secondary|Duration of Response, the Length of Time, in Months, That Protocol Treatment Produced an Objective Improvement in Patients’ Disease|The Response Duration was calculated from time of initial measured response to date of first observation of progressive disease.|18 months|All patients were assessed for response. Only patients with objective response were analyzed for response duration.||Months||95% Confidence Interval|Median
719203|NCT00294684|Secondary|Height Z-Score|Height by Age Z-score over the course of the study|HPE to age 24 Months|||Z-score||Standard Error|Mean
717914|NCT00284154|Primary|Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment|Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters. The final response criteria assigned represented the best response obtained during treatment.|18 months|All patients were assessed for response.||percentage of participants||95% Confidence Interval|Number
717915|NCT00284180|Primary|Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|18 months|||percentage of participants||95% Confidence Interval|Number
717916|NCT00274261|Secondary|Incidence of Adverse Events.|Evaluated by comparing the incidence of Adverse Events (AEs) among subjects using their assigned treatment for at least one day.|The DSMB will review safety data at 3 months following 200 subjects enrolled, 3 months following 400 subject enrolled, as well as additional meetings as needed.||||||
717917|NCT00274261|Primary|The Cumulative Probability of Typical-use 6 Month (183 Days) Pregnancy.|Number of pregnancies in women using C31G gel for 6 months (183 days) compared to women using Conceptrol gel for the same time frame.|6 months|Modified Intent-To-Treat (MITT): ITT subjects whose diaries indicated they had at least one episode of coitus while using the assigned study product (also referred as “Typical-Use”) and for whom there is at least one report of pregnancy status.||6 month probability of pregnancy||95% Confidence Interval|Number
717918|NCT00274287|Secondary|These Include Response Rate (RR), Overall Survival (OS), Toxicity and Safety of Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF), and Time to Requiring Additional Systemic Chemotherapy (TTRC)||time events happen||||||
717919|NCT00274287|Primary|Time to Disease Progression (TTP)|The primary end point of this study is to evaluate time to disease progression (TTP). TTP is defined as the time from starting taxotere until there is evidence of progressive disease (PD) as defined below (radiographically and/or biochemically.|time to disease progression (up to 6 months)|Per protocol.||months||Full Range|Median
717920|NCT00274456|Other Pre-specified|Nadir of Myelosuppression (Over All Cycles) as Measured by Hemoglobin (Hb) Counts|Maximal degree of myelosuppression is represented by the nadir in hemoglobin (Hb) measurements over all treatment cycles.|Day 1 up to 125 weeks|The treated population consisted of all randomized participants who received at least one dose of study drug, and had blood tests performed following treatment. Three participants dropped out after a single dose so have no post-treatment lab values.||g/L||Standard Deviation|Mean
717921|NCT00274456|Secondary|Participants With Treatment-Emergent, Treatment-Related Adverse Events|Summary of participants who had treatment-emergent that were treatment-related in the opinion of the investigator, and summarized in a variety of categories. The National Cancer Institute (NCI)'s Common Terminology Criteria for AEs (CTCAE) was used to grade AE severity: severity grade 3= severe and undesirable AE. Severity grade 4= life-threatening or disabling AE. Severity grade 5 = death.|Day 1 up to 125 weeks|The treated population consisted of all randomized participants who received at least one dose of study drug||participants|||Number
717922|NCT00274456|Other Pre-specified|Nadir of Myelosuppression (Over All Cycles) as Measured by Absolute Neutrophils (ANC), White Blood Cells (WBC) and Platelet Counts|Maximal degree of myelosuppression is represented by the nadir in absolute neutrophil (ANC), white blood cell (WBC), and platelet measurements over all treatment cycles.|Day 1 up to 125 weeks|The treated population consisted of all randomized participants who received at least one dose of study drug, and had blood tests performed following treatment. Three participants dropped out after a single dose so have no post-treatment lab values.||10^9/L||Standard Deviation|Mean
717923|NCT00274456|Secondary|Kaplan-Meier Estimate for Overall Survival (OS)|Participant survival was defined as the date of randomization to the date of death. Participants that were alive at the time of analysis were censored at the last known time that the participant was alive. The final analysis of mature overall survival was conducted after 2 years of follow-up (data cutoff date 31 Jan 2010).|Day 1 to 221 weeks|The treated population consisted of all randomized participants who received at least one dose of study drug||months||95% Confidence Interval|Median
717924|NCT00274456|Secondary|Kaplan-Meier Estimates for Duration of Response Based on Investigator Assessment of Response and Progression|Duration of response was measured as the progression-free survival on patients with confirmed response. The investigator assessment is offered here. Response was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 (Therasse, 2000) and is defined in outcome #1. Progression-free survival is defined in outcome #3.|Day 1 - 95 weeks|Patients with a confirmed CR or PR were included in this analysis. Patients who did not progress or die were censored at the last known time when patient was progression free. Patients who initiated other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated.||months||95% Confidence Interval|Median
717925|NCT00274456|Secondary|Kaplan-Meier Estimates for Duration of Response Based on Independent Radiology Assessment of Response and Progression|Duration of response was measured as the progression-free survival on patients with confirmed response. The independent radiology assessment is offered here. Response was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 (Therasse, 2000) and is defined in outcome #1. Progression-free survival is defined in outcome #3.|Day 1 - 95 weeks|Patients with a confirmed CR or PR were included in this analysis. Patients who did not progress or die were censored at the last known time when patient was progression free. Patients who initiated other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated.||months||95% Confidence Interval|Median
717937|NCT00274651|Secondary|Time to Response|Time to response was defined as the interval between the first date of treatment and the first notation of response.|throughout the study, or for a maximum of 2 years|Time to response (ITT population) was estimated using the Kaplan-Meier method for CTCL and PTCL arms. For 4 patients with CTCL and 6 patients with PTCL, response was recorded. The median time to response and the full range (days) are presented.||Days||Full Range|Median
719204|NCT00294684|Secondary|Weight Z-Score|weight for age Z-score (in subjects without ascites) over the course of the study|HPE until 24 months of age|||Z-score||Standard Error|Mean
717926|NCT00274456|Secondary|Kaplan-Meier Estimates for Progression-free Survival (PFS)|PFS was defined as the time from the date of randomization to the start of disease progression (PD) or patient death (any cause), whichever occurred first. Patients without disease progression were censored at the last time the patient was known to be progression-free. Patients who initiated new anticancer therapy prior to documented progression or death were censored at the start of new therapy. Disease progression was assessed separately by investigators and by an independent radiologist. Both assessments are offered. Response was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 (Therasse, 2000). PD for target lesions is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of the longest diameters recorded since the treatment started; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion.|Day 1 up to 95 weeks|The treated population consisted of all randomized participants who received at least one dose of study drug||months||95% Confidence Interval|Median
717927|NCT00274456|Secondary|Percentage of Participants With Stable Disease for ≥ 16 Weeks, or Complete or Partial Overall Response|Known as the disease control rate, this outcome measures the percentage of participants with stable disease for 16 weeks or more, or had a confirmed complete or partial response (see outcome #1 for confirmed response definitions). Assessments made by independent radiology and by investigators are reported separately|Day 1 up to 95 weeks|The treated population consisted of all randomized participants who received at least one dose of study drug||percentage of participants||95% Confidence Interval|Number
717928|NCT00274456|Primary|Percentage of Participants Showing an Overall Response As Assessed by the Independent Radiology Reader and by the Investigator|Percentage of participants who achieve an objective confirmed complete or partial overall response based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. A complete response (CR) is the disappearance of all known disease and no new sites or disease related symptoms. A partial response (PR) is >= 30% decrease in the sum of the longest diameters of target lesion. PR was also recorded when all measurable disease has completely disappeared, but a non-measurable component (ie, ascites) is still present but not progressing. Overall response (ORR) = CR+PR.|Day 1 up to 95 weeks|The treated population consisted of all randomized participants who received at least one dose of study drug||percentage of participants||95% Confidence Interval|Number
717929|NCT00274469|Secondary|Duration of Clinical Benefit|Time from randomization until earlier of disease progression or death measured only in those patients who achieved clinical benefit.Time from randomization until earlier of disease progression or death measured only in those patients who achieved clinical benefit.|RECIST tumour assessments carried out every 12 weeks from randomization (+/- 2 weeks) until data cut-off on 10th January 2008.|143 of the 205 patients on the study had clinical benefit. Of those 143 patients, 23 subsequently progressed.||Number of CB patients progressed|||Number
717930|NCT00274469|Secondary|Duration of Response|Time from randomization until earlier of progression or death measured only in those patients who achieved a confirmed Complete Response or confirmed Partial Response.|RECIST tumour assessments carried out every 12 weeks from randomization (+/- 2 weeks) until data cut-off on 10th January 2008.|65 of the 205 patients on the study had confirmed RECIST response. Of those 65 responding patients, 14 subsequently progressed.||Number of responders who progres|||Number
717931|NCT00274469|Secondary|Time to Progression|Time from randomization until earlier of disease progression or death|RECIST tumour assessments carried out every 12 weeks from randomization (+/- 2 weeks) until data cut-off on 10th January 2008.|73 of the 205 patients on the study had progressed at the time of data cut-off.||Number of patients who progressed|||Number
717932|NCT00274469|Secondary|Objective Response Rate|An objective response (OR) is defined as a patient having a best overall response of either complete response (CR) or partial response (PR). A patient has best overall response of CRif she had overall response of CR or PR on one visit and met the confirmation criteria perRECIST. ORR is defined as percentage of patients with objective response.|Each patient with measurable disease at baseline was assessed for Objective Response from the sequence of RECIST scan data up to data cut-off, 10th Jan 2008. RECIST scans were performed every 12 weeks (+/- 2 weeks) from randomization.|||Percentaage||Standard Deviation|Mean
717933|NCT00274469|Primary|Clinical Benefit Rate|A Clinical Benefit (CB) responder is defined as a patient having a best overall response ofCR, PR or SD provided SD (or better) was present ≥ 154 days from randomization (ie SD ≥ 24weeks with the 2 week RECIST assessment time window allowed). The Clinical Benefit Rate is the percentage of patients with CB.|Each patient was assessed for Clinical Benefit from the sequence of RECIST (Response Evaluation Criteria In Solid Tumours) scan data up to data cut-off, 10th Jan 2008. RECIST scans were performed every 12 weeks (+/- 2 weeks) from randomization.|||Percentage||Standard Deviation|Mean
717934|NCT00274625|Primary|Incisional Hernia|An obvious defect or interruption of the fascia in the area of the incision that was palpable on clinical examination and/or visible by a cross-sectional imaging modality.|2 years|14 patients in Surgisis Gold group and 8 patients in Suture Closure group were excluded from the analysis, because prior to procedure, either they were found not to meet the inclusion/exclusion criteria, or they chose not to participate.||participants|||Number
717935|NCT00274651|Post-Hoc|Objective Response Rate in Patients With Recurrent or Refractory Cutaneous T-cell Lymphoma (CTCL)|Tumor response was assessed using Cheson (Cheson 2007) and SWAT criteria. The SWAT score represents the product of the percentage total body surface area (TBSA) involvement of each lesion type (patch, plaque, and tumor or ulceration), multiplied by a weighting factor.|throughout the study, or for a maximum of 2 years|At termination OR was noted in 1/13 patients (Simon Stage 1). With 29 patients in the CTCL arm the demand for expansion to Simon Stage 2 lacked 5 patients and the study was stopped. Instead OR was done as secondary efficacy analysis (ITT and PP (per protocol)) with OR calculated without accounting for Simon design and with 95% confidence intervals||participants|||Number
717936|NCT00274651|Secondary|Duration of Response|Duration of response was defined as the time from first notation of response until the time of first notation of disease progression.|throughout the study, or for a maximum of 2 years|Duration of response (ITT population) was estimated by Kaplan-Meier method for CTCL/PTCL arms. 2 CTCL and 2 PTCL patients did not progress and were censored. Median duration of response and full range (days) are presented for 2 patients with CTCL and 4 patients with PTCL. The 2 CTCL patients being evaluable had response durations of 56 and 129 days||Days||Full Range|Median
717938|NCT00274651|Secondary|Time to Progression|Time to progression was defined as the interval between the first date of treatment and the first notation of disease progression.|throughout the study, or for a maximum of 2 years|Time to Progression (ITT population) was estimated using the Kaplan-Meier method for CTCL and PTCL arms. As progression was not observed in six patients in Arm A and 10 patients in Arm B, a total of 37 patients progressed, and the the median time to progression and the full range (days) are presented.||Days||Full Range|Median
717939|NCT00274651|Primary|Objective Response Rate in Patients With Recurrent or Refractory Peripheral T-cell Lymphoma (PTCL))|Tumor response was assessed using the revised criteria of Cheson (Cheson 2007).Tumor assessments were done using conventional radiographic methods, e.g. CT or CT/PET.|throughout the study, or for a maximum of 2 years|Primary efficacy analysis is based on the ITT analysis set, where the OR are calculated, and the proportion ± 80% CI (confidence interval) specified by Koyama & Chen (2008) are presented||percentage of patients with OR|||Number
717940|NCT00274651|Primary|Objective Response Rate in Patients With Recurrent or Refractory Cutaneous T-cell Lymphoma (CTCL)|Tumor response was assessed using Cheson (Cheson 2007) and SWAT criteria. The SWAT score represents the product of the percentage total body surface area (TBSA) involvement of each lesion type (patch, plaque, and tumor or ulceration), multiplied by a weighting factor.|throughout the study, or for a maximum of 2 years|At termination OR was noted in 1/13 patients (Simon Stage 1). With 29 patients in the CTCL arm the demand for expansion to Simon Stage 2 lacked 5 patients and the study was stopped. Instead OR was done as secondary efficacy analysis (ITT and PP (per protocol)) with OR calculated without accounting for Simon design and with 95% confidence intervals|||||
717941|NCT00274716|Primary|Number of Participants Who Were Discontinued From Study Due to Laboratory Adverse Event|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test.|24 weeks|All Patients as Treated (ApaT) population, defined as all randomized participants who received at least 1 dose of double-blind study therapy.||Participants|||Number
717942|NCT00274716|Primary|Number of Participants Who Were Discontinued From Study Due to Clinical Adverse Event|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an AE. A clinical AE was an AE reported as a result of a clinical examination.|24 weeks|All Patients as Treated (ApaT) population, defined as all randomized participants who received at least 1 dose of double-blind study therapy.||Participants|||Number
717943|NCT00274716|Primary|Number of Participants Who Reported a Laboratory Adverse Event|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test.|24 weeks|All Patients as Treated (ApaT) population, defined as all randomized participants who received at least 1 dose of double-blind study therapy.||Participants|||Number
717944|NCT00274716|Primary|Number of Participants Who Reported a Clinical Adverse Event|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an AE. A clinical AE was an AE reported as a result of a clinical examination.|24 weeks|All Patients as Treated (ApaT) population, defined as all randomized participants who received at least 1 dose of double-blind study therapy.||Participants|||Number
717945|NCT00274716|Secondary|Percent Change From Baseline in Triglycerides (TG) at Week 12 in Participants With Higher Body Mass Indices (BMI)|TG measured at baseline and after 12 weeks of study drug administration|Baseline and Week 12 (end of Phase A)|Higher BMI participants in the All Patients Treated (APT) Population, which included all randomized participants who had valid efficacy measurements at baseline and at least once during the double-blind treatment period. The MK-0916 6.0 mg and Placebo Low BMI groups were not included in the planned analysis for this endpoint.||Percent change||Standard Deviation|Mean
717946|NCT00274716|Secondary|Change From Baseline for High Density Lipoprotein Cholesterol (HDL-C) at Week 12 in Participants With Higher BMI|HDL-C measured at baseline and after 12 weeks of study drug administration.|Baseline and Week 12 (end of Phase A)|Higher BMI participants in the All Patients Treated (APT) Population, which included all randomized participants who had valid efficacy measurements at baseline and at least once during the double-blind treatment period. The MK-0916 6.0 mg and Placebo Low BMI groups were not included in the planned analysis for this endpoint.||Percent change||Standard Deviation|Mean
717947|NCT00274716|Secondary|Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 in Participants With Higher Body Mass Indices (BMI)|LDL-C was calculated by the method of Friedewald equation at baseline and after 12 weeks of study drug administration.|Baseline and Week 12 (end of Phase A)|Higher BMI participants in the All Patients Treated (APT) Population, which included all randomized participants who had valid efficacy measurements at baseline and at least once during the double-blind treatment period. The MK-0916 6.0 mg and Placebo Low BMI groups were not included in the planned analysis for this endpoint.||percentage change||Standard Deviation|Mean
717948|NCT00274716|Secondary|Change From Baseline in Waist Circumference at Week 12 in Participants With Higher BMI|Waist circumference measured in cm at baseline and after 12 weeks of study drug administration|Baseline and Week 12 (end of Phase A)|Higher BMI participants in the All Patients Treated (APT) Population, which included all randomized participants who had valid efficacy measurements at baseline and at least once during the double-blind treatment period. The MK-0916 6.0 mg and Placebo Low BMI groups were not included in the planned analysis for this endpoint.||cm||Standard Deviation|Mean
717949|NCT00274716|Secondary|Change From Baseline in Body Weight (kg) at Week 12 in Participants With Higher BMI|Weight was measured in duplicate (2 measurements) at baseline and after 12 weeks of study drug administration. The mean of the 2 values at each assessment was used in analysis.|Baseline and Week 12 (end of Phase A)|Higher BMI participants in the All Patients Treated (APT) Population, which included all randomized participants who had valid efficacy measurements at baseline and at least once during the double-blind treatment period. The MK-0916 6.0 mg and Placebo Low BMI groups were not included in the planned analysis for this endpoint.||kg||Standard Deviation|Mean
717950|NCT00274716|Secondary|Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 12 in Participants With Higher Body Mass Indices (BMI)|Sitting systolic blood pressure measured in triplicate at baseline and after 12 weeks of study drug administration. Mean trough value of the 3 measurements at the 2 timepoints was recorded.|Baseline and Week 12 (end of Phase A)|Higher BMI participants in the All Patients Treated (APT) Population, which included all randomized participants who had valid efficacy measurements at baseline and at least once during the double-blind treatment period. The MK-0916 6.0 mg and Placebo Low BMI groups were not included in the planned analysis for this endpoint.||mm Hg||Standard Deviation|Mean
717951|NCT00274716|Primary|Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 in Participants With Higher Body Mass Indices (BMI)|Sitting diastolic blood pressure measured in triplicate at baseline and after 12 weeks of study drug administration. Mean value of the 3 measurements at the 2 timepoints was recorded.|Baseline and Week 12 (end of Phase A)|Higher BMI participants in the All Patients Treated (APT) Population, which included all randomized participants who had valid efficacy measurements at baseline and at least once during the double-blind treatment period. The MK-0916 6.0 mg and Placebo Low BMI groups were not included in the planned analysis for this endpoint.||mm Hg||Standard Deviation|Mean
717952|NCT00274742|Secondary|Objective Tumor Response According to the Cheson Criteria (With Minimal Response)|"Tumor response was defined according to the Cheson criteria and assessed after 4 and 8 weeks of study treatment using computed tomography (CT) scan (neck, thorax and abdomen/pelvic to assess nodal disease/organ enlargement due to nodal/diffuse infiltration), and bone marrow biopsy (to assess bone marrow infiltration). Minimal response was treated as a separate response category in this analysis. Best clinical response was defined as the best response achieved during the course of the study, whereby the following order was applied: Complete Response, Complete Response Unconfirmed, Partial Response, Minimal Response, Stable Disease, and Progressive Disease.
If no post-baseline tumor assessment was available, the overall clinical response was set to not available."|Assessed after 4 and 8 weeks of treatment|All participants who received at least one infusion of blinatumomab||participants|||Number
717953|NCT00274742|Secondary|Objective Tumor Response According to the Cheson Criteria (Without Minimal Response)|"Tumor response was defined according to the Cheson criteria and assessed after 4 and 8 weeks of study treatment using computed tomography (CT) scan (neck, thorax and abdomen/pelvic to assess nodal disease/organ enlargement due to nodal/diffuse infiltration), and bone marrow biopsy (to assess bone marrow infiltration).
Best clinical response is defined as the best response achieved during the course of the study, with response defined as: Complete Response, Complete Response Unconfirmed, Partial Response, Stable Disease, and Progressive Disease. In this analysis minimal response is set to stable disease as intended in the response categories according to the Cheson criteria. An independent external review by a radiologist (computed tomography scans) and a pathologist (biopsies) was performed to confirm response status.
If no post-baseline tumor assessment was available, the overall clinical response was set to not available."|Assessed after 4 and 8 weeks of treatment|All participants who received at least one infusion of blinatumomab||participants|||Number
717954|NCT00274742|Secondary|Serum Concentration of Blinatumomab|The steady state serum concentration (Css), summarized as the observed concentrations collected at least 10 hours after the start of continuous intravenous infusion or within the sampling window at the end of infusion. Concentrations below the lower limit of quantitation (100 pg/mL) were excluded from analysis.|Up to 24 hours after the end of infusion.|Participants who received blinatumomab and had available pharmacokinetic data||pg/mL||Standard Deviation|Mean
717955|NCT00274742|Primary|Number of Participants With Adverse Events|Participants reporting at least one occurence of any adverse event including clinical symptoms, laboratory abnormalities, serious adverse events, and treatment-limiting adverse events|From the first infusion of blinatumomab until the safety follow-up visit 2 weeks after end of the treatment period, including the consolidation and relapse periods. The median treatment duration was 33.24 days.|All participants who received at least one infusion of blinatumomab||participants|||Number
717956|NCT00274768|Secondary|Adherence and Compliance to Oral Medication Using Electronic Monitoring||Every 3 weeks||||||
717957|NCT00274768|Secondary|Pharmacokinetic and Pharmacodynamic Effects||Time to progression||||||
717958|NCT00274768|Secondary|Clinical Benefit, Time to Treatment Failure, Safety and Toxicity||Time to progression||||||
717959|NCT00274768|Primary|Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Participants were followed to progression, evaluated every 12 weeks|Any participant who completed at least one (1) cycle of capecitabine administration was evaluable for response.||participants|||Number
717960|NCT00274781|Secondary|Tolerability|Tolerability of Therapy was assessed through use of the National Cancer Institute Common Toxicity Criteria (version 3.0). Treatment tolerability was determined based upon whether or not the physician determined therapy was in the patient's best interest, whether the patient wanted to continue therapy or not, whether patients discontinued treatment due to progressive disease, or whether patients discontinued treatment due to toxicity.|12 Weeks|||participants|||Number
717961|NCT00274781|Secondary|Overall Survival|Patient's Overall Survival from date of enrollment to a minimum of three years for survival.|From date of enrollment to a minimum of three years for survival|||months||Full Range|Median
717987|NCT00275301|Primary|Change in Brain Metabolism From Baseline to Eight Weeks as Seen in PET Scan|The primary aim of this imaging study was to examine the effect of olanzapine on brain metabolism over the eight weeks of administration. To compare the baseline PET scan to the endpoint scan,|Baseline to 8 weeks|||Standard uptake value||Standard Deviation|Mean
717988|NCT00275340|Secondary|Depressive Symptoms (Center for Epidemiologic Studies Depression Scale)||9 weeks||09/2009||||
717962|NCT00274781|Primary|Complete and Partial Remission Per the International Working Group (IWG) Criteria for Myelodysplastic Syndromes (MDS) or Acute Myeloid Leukemia (AML)|The null hypothesis to be tested was the percentage who will respond to combination arsenic trioxide (ATO) and gemtuzumab ozogamicin (GO) therapy is <10%. A total of >/= 9 responses observed in 30 evaluable patients was taken as evidence warranting further study of the regimen, provided the toxicity profile also appears favorable. The IWG Criteria standardizes the clinical responses in MDS and AML based upon hematologic improvement, quality of life and cytogenic improvement. These standardizations allow for the responses to be determined as either complete responses or partial responses.|at 12 weeks post treatment|Responses According to IWG MDS Criteria (n=30) Responses According to IWG AML Criteria (n=12)||percentage of patients|||Number
717963|NCT00274846|Secondary|Number of Patients With Complete Remission and Natural Killer Cell Expansion|Includes patients who had both a complete remission of disease and an expansion of natural killer cells.|Day 14|Unable to evaluate due to low complete remission rate.|||||
717964|NCT00274846|Secondary|Overall Survival Time of Patients With Complete Remission|Median number of months patients were alive after NK cell infusion.|From Day 1 of Treatment until death or patient received bone marrow transplant.|||Months||Full Range|Median
717965|NCT00274846|Secondary|Median Time to Disease Relapse (Months)|Follow-up continued every 3 months after the allogeneic natural killer (NK) cell infusion, unless they were transplanted, relapsed or had progressive disease. Time in months to relapse of disease is calculcated from 1st day of treatment with NK cells. Relapse occurs when leukemia is detected in bone marrow or blood.|From 1st Day of treatment until death or receipt of bone marrow transplant.|Only 2 of 20 patients that received adequate Natural Killer Cells achieved complete remission, and were therefore evaluable for the time to relapse endpoint.||Months||Full Range|Median
717966|NCT00274846|Secondary|Number of Patients With Complete Remission|Clinical response is determined by achievement of a complete remission (CR) as judged by morphological criteria (< 1% blasts in bone marrow with neutrophil recovery).|Day 28-35|||Participant|||Number
717967|NCT00274846|Primary|Number of Patients With Natural Killer (NK) Cell Expansion|Evaluation of expansion of donor allogeneic natural killer (NK) cells at day 14 following infusion (>100 donor-derived NK cells per uL of patient blood detectable at day +14).|Study Day 14|||Participants|||Number
717968|NCT00274924|Secondary|5-year Overall Survival|5-year overall survival is defined as the probability of patients who remain alive at 5 years from study entry. The method of Kaplan and Meier (1958) was used to estimate overall survival.|Every 4 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, then every 12 months if patient is 5-10 years from study entry.|||probability||90% Confidence Interval|Number
717969|NCT00274924|Primary|2-year Progression-Free Survival (PFS)|2-year progression-free survival is defined as the probability of patients who remain alive and progression free at 2 years from study entry. The method of Kaplan and Meier (1958) was used to estimate PFS.|Assessed every 4 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, then every 12 months if patient is 5-10 years from study entry.|||probability||90% Confidence Interval|Number
717970|NCT00274937|Secondary|Protective Effects of Amifostine Assessed Primarily by Sialometry: Weight of Unstimulated Saliva Production in Grams.|Weight of unstimulated saliva production in grams.|At study enrollment|Twenty-nine patients in stratum 2 were evaluated at both study enrollment and at the end of consolidation for the weight of unstimulated saliva production. This outcome measure was only collected for patients in Stratum 2.||Grams of saliva||Standard Deviation|Mean
717971|NCT00274937|Secondary|Protective Effects of Amifostine Assessed Primarily by Sialometry|Weight of stimulated saliva production in grams.|At study enrollment|Twenty-six patients in stratum 2 were evaluated at both study enrollment and at the end of consolidation for the weight of stimulated saliva production. This outcome measure was only collected for patients in Stratum 2.||Grams of saliva||Standard Deviation|Mean
717972|NCT00274937|Secondary|Predictive Value of the Detection of EBV DNA in the Peripheral Blood|The prognostic value of the presence of EBV DNA will be assessed using the log-rank test, adjusted by initial stage of disease, if appropriate. The proposed analysis will take place at the analytic endpoint of the clinical trial.|Up to 6 years|Samples have been collected and funding is being sought to perform the necessary laboratory evaluations.|||||
717973|NCT00274937|Secondary|Prognostic Significance of EBV Viral Load|Viral load in blood.|At study enrollment||01/2018||||
717974|NCT00274937|Secondary|Predictive Value of Epstein-Barr Virus (EBV) DNA as Measured by Quantitative Detection at Enrollment on EFS 2 Years After Treatment|Presence of EBV DNA in serum.|At study enrollment||01/2018||||
717975|NCT00274937|Primary|Two Year Event-free Survival (EFS)|The two-year event-free survival will be compared with a standard established from adult oncology data and the results of POG-9486. The two-year Kaplan-Meier estimate of event-free survival will be compared with 70% using a 1-sided test of size 0.05 using the asymptotic distribution of the complementary log-log distribution of the estimate.|Up to Two Year After Enrollment|No patients were enrolled to Stratum 1.||Estimated probability||95% Confidence Interval|Number
717976|NCT00275002|Secondary|Number of Patients With Grade 3 or 4 Adverse Events at Least Possibly Related to the Combination of O6-benzylguanine and Temozolomide|Clinical and laboratory studies to assess adverse events are obtained at least every four weeks (prior to each course) with some laboratory studies obtained every 2 weeks. Adverse events are graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0). Attribution of each adverse event to the treatment regimen is determined by the participant's attending physician at the enrolling institution and verified by the study chair.|From day 1 of therapy up to 49 months|Participants who received at least one day of the treatment regimen were included in the analysis of this objective.||Participants|||Number
717989|NCT00275340|Secondary|Function (Human Activity Profile)||9 weeks||09/2009||||
717990|NCT00275340|Secondary|Interference With Activities (Brief Pain Inventory-Interference Subscale)||9 weeks||09/2009||||
717991|NCT00275340|Secondary|Pain (McGill Pain Questionnaire-Short Form)||9 weeks||09/2009||||
717992|NCT00275340|Primary|Health-related Quality of Life (SF-36v2-acute Form)|The SF-36v2 yields a score for each domain of health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state.|9 weeks|||units on a scale||Standard Deviation|Mean
717977|NCT00275002|Primary|Percentage of Participants With an Objective Response (Complete Response or Partial Response)|The primary endpoint is to assess the percentage of participants with a sustained objective response (complete response (CR) or partial response (PR)). Response is assessed by magnetic resonance imaging (MRI) per the following criteria: CR - disappearance of tumor and PR - ≥50% reduction in tumor based on the maximal cross-sectional measurements. The response must be sustained for at least 8 weeks, and the date of the confirmed sustained response is the date at which the response was first noted by MRI.|Week 8, 16, 24, 32, and 40 after starting therapy|Participants included in assessing objective response were those who completed two courses of therapy or those who died or experienced progressive disease prior to completing the second course.||Percent of Participants||95% Confidence Interval|Number
717978|NCT00275028|Secondary|Progression-free Survival||Up to 2 years|||weeks||Standard Error|Mean
717979|NCT00275028|Primary|Clinical Response Benefit (Modified Gynecologic Cancer InterGroup [GCIG] Cancer Antigen [CA]-125 Response or Stable Disease) Based on the Response Evaluation Criteria in Solid Tumors (RECIST)|"Per Response Evaluation Criteria In Solid Tumors Criteria (RESIST)
Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started"|Up to 12 months|||participants|||Number
717980|NCT00275262|Primary|Mean Change From Baseline in Interferon Gamma Response (Spots/1 Million Cells) Before KLH Vaccination at Month 6 and After KLH Vaccination at Month 7 in Patients Who Received LAD or Placebo|Patients received a subcutaneous injection of KLH vaccine 1 month after subjects received the third injection of LAD or placebo. Interferon gamma was determined by enzyme-linked immunosorbent spot-forming cell (ELISpot). Baseline is defined as the interferon gamma concentration obtained before the KLH vaccination. Change from baseline was calculated as the interferon gamma value postvaccination minus the interferon gamma value at baseline.|Month 6 prevaccination (baseline) and Month 7 postvaccination|Six subjects from the LAD-treated arm and 5 subjects from the placebo-treated arm were assessed for interferon gamma. These subjects received 3 doses of LAD or placebo, KLH vaccination, and had a blood collection suitable for analysis for primary endpoint although not all subjects completed the entire study.||spots/1 million cells||Standard Deviation|Mean
717981|NCT00275262|Primary|Mean Change From Baseline in IgG1 Response (Mcg/mL) Before KLH Vaccination at Month 6 and After KLH Vaccination at Month 7 in Patients Who Received LAD or Placebo|Patients received a subcutaneous injection of KLH vaccine 1 month after subjects received the third injection of LAD or placebo. Serum immunoglobulin IgG1 antibodies were determined by enzyme-linked immunosorbent assay (ELISA). Baseline is defined as the IgG1 concentration before the KLH vaccination. Change from baseline was calculated as the IgG1 value postvaccination minus the IgG1 value at baseline.|Month 6 prevaccination (baseline) and Month 7 postvaccination|Eight subjects from the LAD-treated arm and 5 subjects from the placebo-treated arm were assessed for IgG1. These subjects received 3 doses of LAD or placebo, KLH vaccination, and had a blood collection suitable for analysis for primary endpoint although not all subjects completed the entire study.||mcg/mL||Standard Deviation|Mean
717982|NCT00275262|Secondary|Mean Change From Baseline in TREC Per 100,000 CD8+ Cells to Final Visit in Patients Treated With LAD (11.25 mg) or Placebo After Transplant|"CD8+ cells are a type of T cell. T cells are produced in the thymus and thymic function can be determined by TREC. By counting the number of TRECs present (only 1 copy per cell) within a population of CD8+ cells, an assessment of T cell recovery and immune response is obtained. Mayo Medical Clinic. http://www.mayomedicallaboratories.com/test-catalog/Clinical+and+Interpretive/87959. Accessed 17 MARCH 2010
The change from baseline is defined as posttransplant TREC/100,000 CD8+ cells minus pretransplant TREC /100,000 CD8+ cells."|Pretransplant and posttransplant (Month 12)|Eight subjects from the LAD-treated arm and 5 subjects from the placebo-treated arm were assessed for TREC per 100,000 CD8+ cells. These subjects received 3 doses of LAD or placebo, KLH vaccination, and had a blood collection suitable for analysis for primary endpoint although not all subjects completed the entire study.||TREC /100,000 CD8+ cells||Standard Deviation|Mean
717983|NCT00275262|Secondary|Mean Change From Baseline in T Cell Excision Circles (TREC) Per 100,000 CD4+ Cells to Final Visit in Patients Treated With LAD (11.25 mg) or Placebo After Transplant|"CD4+ cells are a type of T cell. T cells are produced in the thymus and thymic function can be determined by TREC. By counting the number of TRECs present (only 1 copy per cell) within a population of CD4 cells, an assessment of T cell recovery and immune response is obtained. Mayo Medical Clinic. http://www.mayomedicallaboratories.com/test-catalog/Clinical+and+Interpretive/87959. Accessed 17 MARCH 2010
The change from baseline is defined as posttransplant TREC/100,000 CD4+ cells minus pretransplant TREC /100,000 CD4+ cells."|Pretransplant and posttransplant (Month 12)|Nine subjects from the LAD-treated arm and 7 subjects from the placebo-treated arm were assessed for TREC per 100,000 CD4+ cells. These subjects received 3 doses of LAD or placebo, KLH vaccination, and had a blood collection suitable for analysis for primary endpoint although not all subjects completed the entire study.||TREC /100,000 CD4+ cells||Standard Deviation|Mean
717984|NCT00275262|Primary|Mean Change From Baseline in IgM Response (Mcg/mL) Before Keyhole Limpet Hemocyanin (KLH) Vaccination at Month 6 and After KLH Vaccination at Month 7 in Patients Who Received LAD or Placebo|Patients received a subcutaneous injection of KLH vaccine 1 month after subjects received the third injection of LAD or placebo. Serum immunoglobulin IgM antibodies were determined by enzyme-linked immunosorbent assay (ELISA). Baseline is defined as the IgM concentration before the KLH vaccination. Change from baseline was calculated as the IgM value postvaccination minus the IgM value at prevaccination.|Month 6 prevaccination (baseline) and Month 7 postvaccination|Eight subjects from the LAD-treated arm and 5 subjects from the placebo-treated arm were assessed for IgM. These subjects received 3 doses of LAD or placebo, KLH vaccination, and had a blood collection suitable for analysis for primary endpoint although not all subjects completed the entire study.||mcg/mL||Standard Deviation|Mean
717985|NCT00275275|Secondary|Number of Dose Adjustments|Outcome measures the number of times a dose needed to be adjusted to compensate for adverse effects experienced.|Week 4|||number of adjustments||Standard Deviation|Mean
717986|NCT00275275|Primary|Adverse Effects Experienced|Number of adverse effect experienced by participants in the different conversion ratio groups.|Week 4|||number of events|||Number
717993|NCT00275392|Secondary|Dynamic Visual Acuity|Visual acuity during head movement (dynamic visual acuity, DVA) was measured using customized computerized software. DVA is measured in Logarithm of the Minimum Angle of Resolution (LogMAR). Participants identified letters while turning the head from side to side between 120 and 180 deg/s. DVA, the difference in acuity between head stationary and moving, is reported as the average of rightward and leftward scores; higher scores indicate worse visual acuity.|6 weeks|||LogMAR||Standard Deviation|Mean
717994|NCT00275392|Primary|Dynamic Gait Index|Fall risk was determined using the Dynamic Gait Index (DGI). A maximum total score of 24 is possible and a total score of < 20 indicates risk for falling.|6 weeks|Per-protocol analyses (i.e., only subjects who completed the intervention were included).||units on a scale||Standard Deviation|Mean
717995|NCT00275561|Secondary|Number of Participants With Complete Histologic Response|A complete histologic response was defined as >90% decrease in mean eosinophil count/high powered field|2 weeks|Analysis was run per protocol.||participants|||Number
717996|NCT00275561|Secondary|Number of Participants With Partial or Complete Response to Dysphagia|"Measured by the Mayo Dysphagia Questionnaire, a validated 28 item instrument; 0=no dysphagia, higher levels indicate greater dysphagia severity. A complete symptom response was defined as an answer of no to the question In the past 2 weeks, have you had trouble swallowing, not associated with other cold symptoms (such as strep throat or mono)? A partial symptom response was defined as an answer of yes to the above question and a decrease in severity of at least 2 levels, or a decrease in frequency of at least 1 level."|2 weeks|Analysis was run per protocol.||participants|||Number
717997|NCT00275561|Primary|Number of Participants With Complete Response to Dysphagia|"Measured by the Mayo Dysphagia Questionnaire, a validated 28 item instrument; 0=no dysphagia, higher levels indicate greater dysphagia severity. A complete symptom response was defined as an answer of no to the question In the past 2 weeks, have you had trouble swallowing, not associated with other cold symptoms (such as strep throat or mono)?"|2 weeks|Analysis was run per protocol.||participants|||Number
717998|NCT00284518|Post-Hoc|Change From Baseline in IPSS at Week 12 in Patients Previously Treated With Alpha-blockers|The International Prostate Symptom Score (IPSS) is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consists of seven items. The patient evaluates their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score can range from 0 (no symptoms) to 35 (most severe symptoms). A negative change from baseline indicates improvement.|Baseline, Week 12|Participants from the Intent-to-treat population previously treated with alpha-blockers with data available for analyses.||Score on a scale||Standard Deviation|Mean
717999|NCT00284518|Other Pre-specified|Change From Baseline in the International Index of Erectile Function (IIEF) Questionnaire Erectile Function Domain|The IIEF is a 15-item questionnaire filled out by the patient to assess erectile function over the past 4 weeks that contains five domains. The score for the erectile function domain is the sum of scores for Questions 1, 2, 3, 4, 5 and 15 for a total possible score of 1 to 30. A higher score indicates a better outcome. A positive change from baseline indicates improvement.|Baseline, Week 12, Week 72|Participants from the intent-to-treat population (includes all randomized participants) with data available for analyses at the given time-point.||Score on a scale||Standard Deviation|Mean
718000|NCT00284518|Secondary|Change From Baseline in Post-Void Residual|Post-void residual urine volume was assessed by bladder scan or ultrasound on all participants at baseline and various time-points during the study. After voiding, any residual urine volume in the bladder was measured. A negative change from baseline indicates improvement.|Baseline, Week 2, Week 12, Week 72|Participants from the safety population (includes all randomized and treated participants) with data available for analyses at the given time-point.||milliliters (mL)||Standard Deviation|Mean
718001|NCT00284518|Secondary|Change From Baseline in Transitional Zone Prostate Volume|Measurement of the transitional zone prostate volume was performed via transrectal ultrasound at baseline and various time-points during the study. The prostate gland was scanned and the volume was calculated using the formula: Volume (mL) = length × width × height × 0.523. A negative change from baseline indicates improvement.|Baseline, Week 12, Week 72|Participants from the intent-to-treat population (includes all randomized participants) with data available for analyses at the given time-point.||milliliters (mL)||Standard Deviation|Mean
718002|NCT00284518|Secondary|Change From Baseline in Total Prostate Volume|Measurement of the prostate volume was performed via transrectal ultrasound at baseline and various time-points during the study. The prostate gland was scanned and the volume was calculated using the formula: Volume (mL) = length × width × height × 0.523. A negative change from baseline indicates improvement.|Baseline, Week 12, Week 72|Participants from the intent-to-treat population (includes all randomized participants) with data available for analyses at the given time-point.||milliliter (mL)||Standard Deviation|Mean
718003|NCT00284518|Secondary|Change From Baseline in Peak Urine Flow Rate|Urinary flow was determined by uroflowmetry at baseline and various time-points during the study. An increase from baseline indicates improvement.|Baseline, Week 12, Week 72|Participants from the intent-to-treat population (includes all randomized participants) with data available for analyses at the given time-point.||milliliters (mL)/second||Standard Deviation|Mean
718004|NCT00284518|Secondary|Change From Baseline in International Prostate Symptom Score (IPSS) at Week 72|The International Prostate Symptom Score is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consists of seven items. The patient evaluates their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score can range from 0 (no symptoms) to 35 (most severe symptoms). A negative change from baseline indicates improvement.|Baseline, Week 72|Participants from the intent-to-treat population (includes all randomized participants) with data available for analyses at the given time-point.||Score on a scale||Standard Deviation|Mean
718025|NCT00285779|Secondary|"The Percentage of Placebo Patients Who do Not Have a Complete Response (Defined as a Physician Global Assessment of Clear) at 12 Weeks"||12 weeks||||||
718026|NCT00285779|Secondary|The Number and Percentage of Subjects Experiencing Serious Adverse Events (SAE) on Etanercept and Placebo||12 and 24 weeks||||||
718027|NCT00285779|Secondary|Patient Assessment of Overall Disease Severity (Patient Global Assessment) at 12 and 24 Weeks||12 and 24 weeks||||||
718028|NCT00285779|Secondary|Patient Assessment of Pruritus/Itching on a Visual Analogue Scale (VAS) at 12 and 24 Weeks||12 and 24 weeks||||||
718005|NCT00284518|Primary|Change From Baseline in International Prostate Symptom Score (IPSS) at Week 12|The International Prostate Symptom Score is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consists of seven items. The patient evaluates their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score can range from 0 (no symptoms) to 35 (most severe symptoms). A negative change from baseline indicates improvement.|Baseline, Week 12|Participants from the intent-to-treat population (includes all randomized participants) with data available for analyses at the given time-point.||Score on a scale||Standard Deviation|Mean
718006|NCT00284557|Primary|BMI Z-score(for Gender and Age)at 12-months|The body mass index (BMI) for a given age (in years and monthys) and gender (male or female) converted to an exact z-score.|12-months post-intervention|||Z-score||Standard Deviation|Mean
718007|NCT00284557|Secondary|"Change in Eating Behaviors (Consumption of WHOA Foods), Physical Activity, and Screen Time"||6- and 12-months post-intervention||||||
718008|NCT00284557|Primary|BMI Z-score(for Gender and Age)at 6-months|The body mass index (BMI) for a given age (in years and monthys) and gender (male or female) converted to an exact z-score.|6-months post-intervention|||Z-score||Standard Deviation|Mean
718009|NCT00285207|Secondary|Immunologic Parameters B/T Cells Will be Assessed by B/T Cell Profile Collection.||over the course of the trial||||||
718010|NCT00285207|Secondary|Eradication of Human Papilloma Virus (HPV) Will be Assessed by Way of Cervical Cytology and Swab Collection.||over the course of the trial||||||
718011|NCT00285207|Secondary|Local Tolerability and Systemic Safety of A-007 Will be Assessed by Way of CTCAE 3.0.||over the course of the trial||||||
718012|NCT00285207|Primary|Pathological Response|Pathological resonse is defined as a patient who regressed from Cervical intraepithelial neoplasia (CIN) 2/3 to normal at the end of 4 months.|baseline and 4 months|||participants|||Number
718013|NCT00285246|Primary|Health Care Utilization|This variable is a sum score of the self-reported number of healthcare provider visits and emergency room visits in the prior 12 months.|pre-deployment (Phase 1), immediate post-deployment (Phase 2), 3 months post-return (Phase 3), 1 year post-return (Phase 4)|Not all of the 790 completers has complete data on the healthcare utilization measure.||number of visits in prior 12 months||Standard Deviation|Mean
718014|NCT00285246|Primary|Mental Functional Status|Mental Component Summary Score (MCS) from the Veterans-RAND (VR) 36 (Kazis, 2000). MCS is a composite score with a mean of 50 and a standard deviation of 10. Scale scores range from 0-100 with higher scores reflecting better mental function.|pre-deployment, immediate post-deployment, 3 months post-return, 1 year post-return|Not all of the 790 completers has complete data on the mental functional status measure.||units on a scale||Standard Deviation|Mean
718015|NCT00285246|Primary|Physical Functional Status|Physical Component Summary Score (PCS) from the Veterans RAND (VR) 36 measure (Kazis, 2000). Composite scores are normed to a mean of 50 and a SD of 10. Scores can range from 0-100. Higher scores indicate better physical function.|pre-deployment (Phase 1), immediate post-deployment (Phase 2), 3 months post-return (Phase 3), 1 year post-return (Phase 4)|Not all of the 790 completers has complete data on this physical functional status measure.||Units on a scale||Standard Deviation|Mean
718016|NCT00285246|Primary|Non-Specific Physical Symptoms|Severity of non-specific physical symptoms from the 15 item Patient Health Questionnaire-15 (Kroenke, Spitzer & Williams, 2002). Scale score range is 0-30. Higher scores indicate greater non-specific physical symptom severity. This scale does not contain subscales.|pre-deployment (Phase 1), immediately post-deployment (Phase 2), 3 months post-return from deployment (Phase 3), 1 year post-return from deployment (Phase 4)|Not all of the 790 completers has complete data on the non-specific physical symptoms measure.||units on a scale||Standard Deviation|Mean
718017|NCT00285467|Secondary|Systolic Blood Pressure at 3 Months|systolic blood pressure at 3 months|3 month|||mmHg||Standard Deviation|Mean
718018|NCT00285467|Primary|Percent Reduction in PTH|Percent reduction in PTH from baseline to 3 months|3 month|The initial sample size was based on the published response to doxercalciferol versus placebo where a 46% reduction in PTH was observed over 6 months, with a 51% SD. The expected reduction in PTH with cholecalciferol was based on the best-case scenario decrease of 17.8% in PTH with ergocalciferol from our own clinic setting.||% change in PTH baseline to 3 months||Standard Deviation|Mean
718019|NCT00285584|Secondary|Change in Beck Depression Inventory - II (BDI-II) Scores Between Enrollment and Month 6.|The BDI-II is a self-administered, multiple-choice questionnaire inquiring into the presence and severity of symptoms associated with depression. BDI-II scores range from 0 to 63, with 10-19 interpreted as mild-to-moderate; 20-29 as moderate-to-severe, and ≥ 30 as severe depression. The study outcome measure was the BDI-II score at Month 6 minus the BDI score at enrollment|Month 6 compared to enrollment (Month 0)|||units on a scale||Full Range|Median
718020|NCT00285584|Secondary|Incidence of Sexually Transmitted Infections Between Study Entry and Month 6 (Measured by Questionnaire and Laboratory Testing)|Number of participants with incident sexually transmitted disease between enrollment the Month 6 interview.|Enrollment to Month 6|Self-reported and laboratory identified sexually transmitted infections||participants|||Number
718021|NCT00285584|Secondary|Change in the Frequency Per Month of Use of Recreational Drugs Between Enrollment and Month 6 Measured by Questionnaire.|Within-individual changes in the frequency of use of recreational drugs per month in the 3 months prior to interview reported at the Month 6 visit minus that reported at the enrollment visit.|Month 6 compared to Month 0 (enrollment)|All subjects who were randomized, met study inclusion/exclusion criteria and were followed through Month 6||Drug-using occasions per month||Full Range|Median
718022|NCT00285584|Primary|The Number of Sexual Partners in Unprotected Anal Intercourse Reported at 6 Months Minus the Number Reported at Enrollment.|The self-reported number of partners in unprotected anal intercourse during the 3 months prior to interview as reported at the Month 6 visit minus reported at the enrollment visit.|Enrollment to Month 6|Subjects remaining in study through 6-Month study visit.||Sexual partners||Full Range|Median
718023|NCT00285649|Primary|Roland Morris Low Back Pain Disability Questionnaire (RMDQ)|The RMDQ is a widely used health status measure for low back pain. Scoring of the RMDQ ranges from 0-24, with a higher score indicating an increase in low back pain disability. This outcome displays the mean change in RMDQ from baseline to week 3.|Mean change from baseline to week 3|||units on a scale||Standard Deviation|Mean
718024|NCT00285779|Secondary|The Percentage of Placebo and Study-drug Patients Able to Discontinue Use of Topical Corticosteroids Through Week 24||24 weeks||||||
718033|NCT00285779|Primary|The Percentage of Patients Achieving a Response in Mucosal Disease (or Cutaneous Disease if no Mucosal Disease) at 12 Weeks|This is a physician global assessment of disease (0=clear; 1=minimal disease; 2=mild disease; 3=moderate disease; 4=severe disease). The subject have a level >=3 at baseline. To be considered a responder, the subject must achieve a level of 0 or 1, or, at least a 2 point improvement in the scale.|12 weeks|Intention to treat analysis (all participants received at least one dose of study drug). Missing data imputed using Last Observation Carried Forward (LOCF).||percentage of participants|||Number
718034|NCT00285818|Primary|Hamilton Depression Rating Scale Score|The Hamilton Depression Scale measures the severity of depression. There are 17 items rated 0 to 4. A total score of 0 indicates that the patient does not endorse any symptoms of depression. The maximum score (the most severe depression) is 68. The outcome measure is the difference between Visit 1 and Visit 4 Hamilton Depression Rating Scale scores of the mifepristone and placebo groups.|Screening to Final Visit|||units on a scale||Standard Deviation|Mean
718035|NCT00285857|Secondary|Change in Low Density Lipoprotein (LDL) After Treatment With Lovastatin 80 mg/Day||6 months|Change in mean of LDL level, with standard deviation of the values at||mg/dL||Standard Deviation|Mean
718036|NCT00285857|Secondary|Change in Total Cholesterol After Treatment With Lovastatin 80 mg/Day||6 months|||mg/dL||Standard Deviation|Mean
718037|NCT00285857|Secondary|Change in Mammographic Density Before and After Treatment With Lovastatin 80 mg/Day|"Bilateral mammography was performed at study entry (before lovastatin therapy) and at study conclusion (after lovastatin therapy) . Mammograms were assessed for a decline in mean breast density, using the American College of Radiology Breast Imaging Reporting and Data System (BI-RAD) composition system for mammographic density assessment.
Category 0 Need additional imaging evaluation
Negative
Benign
Probably benign
Suspicious abnormality
Highly suggestive of malignancy
Known biopsy-proven malignancy"|6 months|Outcome reported as the change in mean mammographic density with standard deviation (SD) of the post-treatment measurements.||BI-RADS||Standard Deviation|Mean
718038|NCT00285857|Primary|Change in the Incidence of Abnormal Breast Duct Cytology After Treatment With Lovastatin 80 mg/Day|"Assessed on that basis of pre- and post-treatment evaluation with RPFNA (random periareolar fine needle aspiration). All subjects received a prescription for lovastatin 80 mg/day, to be taken as 40 mg twice-a-day.
Cytology was qualitatively and quantitatively, using the Masood semiquantitative scale to assign a number to each specimen, with higher numbers indicating increasing degrees of abnormality, as follows:
06-10 Non-proliferative breast disease (NPBD)
11–14 Proliferative breast disease without atypia (PBD-A)
15–18 Proliferative breast disease with atypia (PBD+A)
19–24 Carcinoma in situ and invasive cancer (CIS/IC)
If no cells could be obtained after multiple RPFNA attempts, the classification was acellular.
Change from NPBD to PBD-A was considered Unfavorable.
Change from NPBD to Acellular was considered Equivocal.
Change from PBD-A to NPBD was considered Favorable."|6 months|"Participants either at least one of the following:
Deleterious germline mutation in BRCA1, BRCA2, CDH1, or TP53
Lifetime breast cancer risk of breast cancer of 20 % as estimated by the Claus model
Personal history of estrogen receptor andprogesterone receptor-negative breast cancer."||participants|||Number
718039|NCT00286078|Primary|Frequency of Adverse Event|Cumulative frequency of adverse events from randomization to 26 weeks|26 weeks|||events|||Number
718040|NCT00286078|Primary|Migraine Frequency at 12 Weeks|Change from baseline in migraine days/month at 12 weeks|Baseline and 12 weeks|Modified Intent to Treat||days||Standard Deviation|Mean
718041|NCT00286091|Secondary|Overall Survival|Time from randomization to the date of death. Participants who were still alive or lost to follow-up by the primary analysis data cut-off date were censored at their last contact date (on-study or during survival follow-up) or the primary analysis data cut-off date, whichever was first.|From the first dose of investigational product to the primary data cutoff date of 30 July 2010; median time on study was approximately 20 months.|Full analysis set||days||95% Confidence Interval|Median
718042|NCT00286091|Secondary|Time to First Bone Metastasis|Time from randomization to the date of first occurrence of bone metastasis (either symptomatic or asymptomatic), excluding death. Participants who did not develop bone metastasis were censored at their last on-study bone assessment date or the primary analysis data cut-off date, whichever was first. Median time to first bone metastasis was estimated using the Kaplan-Meier method.|From the first dose of investigational product to the primary data cutoff date of 30 July 2010; median time on study was approximately 20 months.|Full analysis set||days||95% Confidence Interval|Median
718043|NCT00286091|Primary|Bone Metastasis-free Survival|The time to the first occurrence of bone metastasis (either symptomatic or asymptomatic) or death from any cause. Participants who did not experience bone metastasis or on-study death were censored at the last on-study contact date or the primary analysis data cutoff date, whichever came first. Median bone metastasis-free survival time was estimated using the Kaplan-Meier method.|From the first dose of investigational product to the primary data cutoff date of 30 July 2010; median time on study was approximately 20 months.|Full analysis set (all randomized participants)||days||95% Confidence Interval|Median
718044|NCT00286156|Secondary|Change in Total Kidney Volume as Measured by 3D-CT From Baseline to 12 Months|Total kidney volume measured by CT from baseline to 12 months|From baseline to 12 months|||ml||Standard Deviation|Mean
718045|NCT00286156|Primary|Change in GFR From Baseline to 12 Months|GFR (glomerular filtration rate) was measured by iothalamate. GFR is a key indicator of renal function.|From baseline to 12 months|||ml/min/1.73m^2||Standard Deviation|Mean
718046|NCT00286182|Primary|Change in Left Ventricular End-diastolic Volume|This outcome measure is collected using a three dimensional echocardiography.|Baseline and 6 month|||mL||Standard Error|Mean
718047|NCT00286221|Secondary|Fentanyl Consumption|the amount of fentanyl is that administered in response to corresponding rest pain levels. Thus, the 0 hour indicates the amount of fentanyl administered from the time of admission until the end of the first hour. Also note that once pain assessments are made every other hour (e.g., 10, 12, 14, and 16), the analgesic totals indicated are for the corresponding 2-hour period after the pain assessment, and were halved to estimate the hourly rate of analgesic consumption.|Up to 16 hours|||mcg/hour||Standard Deviation|Mean
718048|NCT00286221|Primary|Hourly Pain Scores|Patients’ Numerical Rating Scale scores (0–10: 0 = no pain, 10 = worst imaginable pain)|Up to 16 hours|||units on a scale||Standard Deviation|Mean
718049|NCT00286325|Secondary|B Cell Number at Week 24|Peripheral blood B cell number at week 24 compared to B cell number at week 0|Week 0 and at 24 weeks|excluded subject with epidermolysis bullosa acquisita diagnosed after study entry||B cells per microliter||Full Range|Median
718050|NCT00286325|Secondary|IgG Anti Bullous Pemphigoid (BP) 180 Measured in Units by ELISA at Week 24.|IgG antibodies against BP 180 measured in units (by ELISA) for each participant at week 0 compared to value at week 24,|Week 0 and at 24 weeks|Excluded subject with diagnosis of epidermolysis bullosa acquisita made after study entry, excluded one subject with no circulating antibodies measured at either time point.||Elisa Units||Full Range|Median
718051|NCT00286325|Secondary|Systemic Corticosteroid Dose of 25% of Starting Dose or 10 mg/Day by Week 24|Subject systemic corticosteroid dosage at week 24 was 25% of starting dose or 10 mg/day of prednisone or less|24 weeks|Excluded subject with epidermolysis bullosa acquisita diagnosed after study entry.||participants|||Number
718052|NCT00286325|Primary|Primary Safety Endpoint|The primary safety endpoint is the occurrence of treatment emergent adverse events including infections, infusion reactions and disease progression. These were determined by clinical evaluation and laboratory questions. Disease progression is defined as development of new blisters despite therapy. These are reported as the number of participants with a study related SAE.|1 year|The safety analysis was performed on all subjects||participants|||Number
718053|NCT00286325|Secondary|Number of Days to Cessation of New Blister|The first study visit in which patient reported and was confirmed to have no new blister or lesion formation .|1 year|Excluded subject with diagnosis of epidermolysis bullosa acquisita , made after study entry.||Days||Full Range|Median
718054|NCT00286429|Secondary|Change From Baseline in Body Weight (Week 26).|The change between Body Weight measured at week 26 or final visit and Body Weight measured at baseline.|Baseline and Week 26.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 26. Missing data are imputed using last observation carried forward (LOCF).||kg||Standard Error|Least Squares Mean
718055|NCT00286429|Secondary|Change From Baseline in Body Weight (Week 20).|The change between Body Weight measured at week 20 and Body Weight measured at baseline.|Baseline and Week 20.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 20. Missing data are imputed using last observation carried forward (LOCF).||kg||Standard Error|Least Squares Mean
718056|NCT00286429|Secondary|Change From Baseline in Body Weight (Week 12).|The change between Body Weight measured at week 12 and Body Weight measured at baseline.|Baseline and Week 12.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 12. Missing data are imputed using last observation carried forward (LOCF).||kg||Standard Error|Least Squares Mean
718057|NCT00286429|Secondary|Change From Baseline in Body Weight (Week 8).|The change between Body Weight measured at week 8 and Body Weight measured at baseline.|Baseline and Week 8.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 8. Missing data are imputed using last observation carried forward (LOCF).||kg||Standard Error|Least Squares Mean
718058|NCT00286429|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 2.0%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 2.0% during the 26 week study.|Baseline and Week 26.|"Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had at least 1 HbA1c measurement after baseline.
Due to no participants in the placebo arm achieved HbA1c decrease from baseline ≥2.0%, the odds ratio of alogliptin to placebo and 95% CI were not estimable from the logistic regression."||participants|||Number
718059|NCT00286429|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.5%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.5% during the 26 week study.|Baseline and Week 26.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had at least 1 HbA1c measurement after baseline.||participants|||Number
718060|NCT00286429|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.0%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.0% during the 26 week study.|Baseline and Week 26.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had at least 1 HbA1c measurement after baseline.||participants|||Number
718061|NCT00286429|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 0.5%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 0.5% during the 26 week study.|Baseline and Week 26.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had at least 1 HbA1c measurement after baseline.||participants|||Number
718062|NCT00286429|Secondary|Number of Participants With Glycosylated Hemoglobin ≤ 7.5%.|The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 7.5% during the 26 week study.|Baseline and Week 26.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had at least 1 HbA1c measurement after baseline.||participants|||Number
718063|NCT00286429|Secondary|Number of Participants With Glycosylated Hemoglobin ≤ 7.0%.|The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 7.0% during the 26 week study.|Baseline and Week 26.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had at least 1 HbA1c measurement after baseline.||participants|||Number
718064|NCT00286429|Secondary|Number of Participants With Glycosylated Hemoglobin ≤ 6.5%.|The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 6.5% during the 26 week study.|Baseline and Week 26.|"Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who completed at least 1 HbA1c measurement after baseline.
Due to no participants in the placebo arm achieved HbA1c ≤ 6.5%, the odds ratio of alogliptin to placebo and 95% CI were not estimable from the logistic regression."||participants|||Number
718095|NCT00286442|Secondary|Number of Participants With Glycosylated Hemoglobin ≤ 7.5%.|The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 7.5% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set).||participants|||Number
718065|NCT00286429|Secondary|Change From Baseline in C-peptide (Week 26).|The change between the value of C-peptide collected at week 26 or final visit and C-peptide collected at baseline.|Baseline and Week 26.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 26. Missing data are imputed using last observation carried forward (LOCF).||ng/mL||Standard Error|Least Squares Mean
718066|NCT00286429|Secondary|Change From Baseline in C-peptide (Week 20).|The change between the value of C-peptide collected at week 20 and C-peptide collected at baseline.|Baseline and Week 20.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 20. Missing data are imputed using last observation carried forward (LOCF).||ng/mL||Standard Error|Least Squares Mean
718067|NCT00286429|Secondary|Change From Baseline in C-peptide (Week 16).|The change between the value of C-peptide collected at week 16 and C-peptide collected at baseline.|Baseline and Week 16.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 16. Missing data are imputed using last observation carried forward (LOCF).||ng/mL||Standard Error|Least Squares Mean
718068|NCT00286429|Secondary|Change From Baseline in C-peptide (Week 12).|The change between the value of C-peptide collected at week 12 and C-peptide collected at baseline.|Baseline and Week 12.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 12. Missing data are imputed using last observation carried forward (LOCF).||ng/mL||Standard Error|Least Squares Mean
718069|NCT00286429|Secondary|Change From Baseline in C-peptide (Week 8).|The change between the value of C-peptide collected at week 8 and C-peptide collected at baseline.|Baseline and Week 8.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 8. Missing data are imputed using last observation carried forward (LOCF).||ng/mL||Standard Error|Least Squares Mean
718070|NCT00286429|Secondary|Change From Baseline in C-peptide (Week 4).|The change between the value of C-peptide collected at week 4 and C-peptide collected at baseline.|Baseline and Week 4.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 4. Missing data are imputed using last observation carried forward (LOCF).||ng/mL||Standard Error|Least Squares Mean
718071|NCT00286429|Secondary|Number of Participants Requiring Rescue.|The number of participants requiring rescue for failing to achieve pre-specified glycemic targets during the 26 week study.|26 Weeks.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who completed at least 1 study visit after baseline.||participants|||Number
718072|NCT00286429|Secondary|Number of Participants With Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg Per dL).|The number of participants with a fasting plasma glucose value greater than or equal to 200 mg per dL during the 26 week study.|26 Weeks.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had at least 1 fasting plasma glucose measurement after baseline.||participants|||Number
718073|NCT00286429|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 26).|The change between the value of fasting plasma glucose collected at week 26 or final visit and fasting plasma glucose collected at baseline.|Baseline and Week 26.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 26. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
718074|NCT00286429|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 20).|The change between the value of fasting plasma glucose collected at week 20 and fasting plasma glucose collected at baseline.|Baseline and Week 20.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 20. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
718075|NCT00286429|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 16).|The change between the value of fasting plasma glucose collected at week 16 and fasting plasma glucose collected at baseline.|Baseline and Week 16.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 16. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
718076|NCT00286429|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 12).|The change between the value of fasting plasma glucose collected at week 12 and fasting plasma glucose collected at baseline.|Baseline and Week 12.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 12. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
718077|NCT00286429|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 8).|The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline.|Baseline and Week 8.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 8. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
718078|NCT00286429|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 4).|The change between the value of fasting plasma glucose collected at week 4 and fasting plasma glucose collected at baseline.|Baseline and Week 4.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 4. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
718079|NCT00286429|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 2).|The change between the value of fasting plasma glucose collected at week 2 and fasting plasma glucose collected at baseline.|Baseline and Week 2.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 2. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
718080|NCT00286429|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 1).|The change between the value of fasting plasma glucose collected at final visit or week 1 and fasting plasma glucose collected at baseline.|Baseline and Week 1.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 1. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
718081|NCT00286429|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 20).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 20 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 20.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 20. Missing data are imputed using last observation carried forward (LOCF).||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
718082|NCT00286429|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 16).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 16 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 16.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 16. Missing data are imputed using last observation carried forward (LOCF).||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
718083|NCT00286429|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 12).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 12.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 12. Missing data are imputed using last observation carried forward (LOCF).||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
718084|NCT00286429|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 8).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 8.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 8. Missing data are imputed using last observation carried forward (LOCF).||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
718085|NCT00286429|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 4).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 4 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 4.|Randomized participants who received at least 1 dose of study drug and who had an HbA1c measurement at baseline and at Week 4. Missing data are imputed using last observation carried forward (LOCF).||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
718086|NCT00286429|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26.|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 26 or final visit and glycosylated hemoglobin collected at baseline.|Baseline and Week 26.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 26. Missing data are imputed using last observation carried forward (LOCF). ANCOVA = Analysis of covariance.||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
718087|NCT00286442|Secondary|Change From Baseline in Body Weight (Week 26).|The change between Body Weight measured at week 26 or final visit and Body Weight measured at baseline.|Baseline and Week 26.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had weight measurements at baseline and at Week 26. Missing data are imputed using last observation carried forward (LOCF).||kg||Standard Error|Least Squares Mean
718088|NCT00286442|Secondary|Change From Baseline in Body Weight (Week 20).|The change between Body Weight measured at week 20 and Body Weight measured at baseline.|Baseline and Week 20.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had weight measurements at baseline and at Week 20. Missing data are imputed using last observation carried forward (LOCF).||kg||Standard Error|Least Squares Mean
718089|NCT00286442|Secondary|Change From Baseline in Body Weight (Week 12).|The change between Body Weight measured at week 12 and Body Weight measured at baseline.|Baseline and Week 12.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had weight measurements at baseline and at Week 12. Missing data are imputed using last observation carried forward (LOCF).||kg||Standard Error|Least Squares Mean
718090|NCT00286442|Secondary|Change From Baseline in Body Weight (Week 8).|The change between Body Weight measured at week 8 and Body Weight measured at baseline.|Baseline and Week 8.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had weight measurements at baseline and at Week 8. Missing data are imputed using last observation carried forward (LOCF).||kg||Standard Error|Least Squares Mean
718091|NCT00286442|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 2.0%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 2.0% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set).||participants|||Number
718092|NCT00286442|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.5%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.5% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set).||participants|||Number
718093|NCT00286442|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.0%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.0% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set).||participants|||Number
718094|NCT00286442|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 0.5%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 0.5% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set).||participants|||Number
718096|NCT00286442|Secondary|Number of Participants With Glycosylated Hemoglobin ≤ 7.0%.|The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 7.0% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set).||participants|||Number
718097|NCT00286442|Secondary|Number of Participants With Glycosylated Hemoglobin ≤ 6.5%.|The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 6.5% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set).||participants|||Number
718098|NCT00286442|Secondary|Change From Baseline in C-peptide (Week 26).|The change between the value of C-peptide collected at week 26 or final visit and C-peptide collected at baseline.|Baseline and Week 26.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had C-peptide measurements at baseline and at Week 26. Missing data are imputed using last observation carried forward (LOCF).||ng/mL||Standard Error|Least Squares Mean
718099|NCT00286442|Secondary|Change From Baseline in C-peptide (Week 20).|The change between the value of C-peptide collected at week 20 and C-peptide collected at baseline.|Baseline and Week 20.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had C-peptide measurements at baseline and at Week 20. Missing data are imputed using last observation carried forward (LOCF).||ng/mL||Standard Error|Least Squares Mean
718100|NCT00286442|Secondary|Change From Baseline in C-peptide (Week 16).|The change between the value of C-peptide collected at week 16 and C-peptide collected at baseline.|Baseline and Week 16.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had C-peptide measurements at baseline and at Week 16. Missing data are imputed using last observation carried forward (LOCF).||ng/mL||Standard Error|Least Squares Mean
718101|NCT00286442|Secondary|Change From Baseline in C-peptide (Week 12).|The change between the value of C-peptide collected at week 12 and C-peptide collected at baseline.|Baseline and Week 12.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had C-peptide measurements at baseline and at Week 12. Missing data are imputed using last observation carried forward (LOCF).||ng/mL||Standard Error|Least Squares Mean
718102|NCT00286442|Secondary|Change From Baseline in C-peptide (Week 8).|The change between the value of C-peptide collected at week 8 and C-peptide collected at baseline.|Baseline and Week 8.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had C-peptide measurements at baseline and at Week 8. Missing data are imputed using last observation carried forward (LOCF).||ng/mL||Standard Error|Least Squares Mean
718103|NCT00286442|Secondary|Change From Baseline in C-peptide (Week 4).|The change between the value of C-peptide collected at week 4 and C-peptide collected at baseline.|Baseline and Week 4.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had C-peptide measurements at baseline and at Week 4. Missing data are imputed using last observation carried forward (LOCF).||ng/mL||Standard Error|Least Squares Mean
718104|NCT00286442|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 26).|The change between the ratio value of proinsulin and insulin collected at week 26 or final visit and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 26.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had insulin and proinsulin measurements at baseline and at Week 26. Missing data are imputed using last observation carried forward (LOCF).||ratio||Standard Error|Least Squares Mean
718105|NCT00286442|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 20).|The change between the ratio value of proinsulin and insulin collected at week 20 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 20.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had insulin and proinsulin measurements at baseline and at Week 20. Missing data are imputed using last observation carried forward (LOCF).||ratio||Standard Error|Least Squares Mean
718106|NCT00286442|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 16).|The change between the ratio value of proinsulin and insulin collected at week 16 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 16.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had insulin and proinsulin measurements at baseline and at Week 16. Missing data are imputed using last observation carried forward (LOCF).||ratio||Standard Error|Least Squares Mean
718107|NCT00286442|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 12).|The change between the ratio value of proinsulin and insulin collected at week 12 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 12.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had insulin and proinsulin measurements at baseline and at Week 12. Missing data are imputed using last observation carried forward (LOCF).||ratio||Standard Error|Least Squares Mean
718108|NCT00286442|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 8).|The change between the ratio value of proinsulin and insulin collected at week 8 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 8.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had insulin and proinsulin measurements at baseline and at Week 8. Missing data are imputed using last observation carried forward (LOCF.||ratio||Standard Error|Least Squares Mean
718109|NCT00286442|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 4).|The change between the ratio value of proinsulin and insulin collected at week 4 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 4.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had insulin and proinsulin measurements at baseline and at Week 4. Missing data are imputed using last observation carried forward (LOCF).||ratio||Standard Error|Least Squares Mean
718110|NCT00286442|Secondary|Change From Baseline in Insulin (Week 26).|The change between the value of insulin collected at week 26 and insulin collected at baseline.|Baseline and Week 26.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a Insulin measurement at baseline and at Week 26. Missing data are imputed using last observation carried forward (LOCF).||mcIU/mL||Standard Error|Least Squares Mean
719310|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and TG|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 weeks|||Correlation coefficient|||Number
718111|NCT00286442|Secondary|Change From Baseline in Insulin (Week 20).|The change between the value of insulin collected at week 20 and insulin collected at baseline.|Baseline and Week 20.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a Insulin measurement at baseline and at Week 20. Missing data are imputed using last observation carried forward (LOCF).||mcIU/mL||Standard Error|Least Squares Mean
718112|NCT00286442|Secondary|Change From Baseline in Insulin (Week 16).|The change between the value of insulin collected at week 16 and insulin collected at baseline.|Baseline and Week 16.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a Insulin measurement at baseline and at Week 16. Missing data are imputed using last observation carried forward (LOCF).||mcIU/mL||Standard Error|Least Squares Mean
718113|NCT00286442|Secondary|Change From Baseline in Insulin (Week 12).|The change between the value of insulin collected at week 12 and insulin collected at baseline.|Baseline and Week 12.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a Insulin measurement at baseline and at Week 12. Missing data are imputed using last observation carried forward (LOCF).||mcIU/mL||Standard Error|Least Squares Mean
718114|NCT00286442|Secondary|Change From Baseline in Insulin (Week 8).|The change between the value of insulin collected at week 8 and insulin collected at baseline.|Baseline and Week 8.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a Insulin measurement at baseline and at Week 8. Missing data are imputed using last observation carried forward (LOCF).||mcIU/mL||Standard Error|Least Squares Mean
718115|NCT00286442|Secondary|Change From Baseline in Insulin (Week 4).|The change between the value of insulin collected at week 4 and insulin collected at baseline.|Baseline and Week 4.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had an insulin measurement at baseline and at Week 4. Missing data are imputed using last observation carried forward (LOCF).||mcIU/mL||Standard Error|Least Squares Mean
718116|NCT00286442|Secondary|Change From Baseline in Fasting Proinsulin (Week 26).|The change between the value of fasting proinsulin collected at week 26 or final visit and fasting proinsulin collected at baseline.|Baseline and Week 26.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a PROINSULIN measurement at baseline and at Week 26. Missing data are imputed using last observation carried forward (LOCF).||pmol/L||Standard Error|Least Squares Mean
718117|NCT00286442|Secondary|Change From Baseline in Fasting Proinsulin (Week 20).|The change between the value of fasting proinsulin collected at week 20 and fasting proinsulin collected at baseline.|Baseline and Week 20.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a proinsulin measurement at baseline and at Week 20. Missing data are imputed using last observation carried forward (LOCF).||pmol/L||Standard Error|Least Squares Mean
718118|NCT00286442|Secondary|Change From Baseline in Fasting Proinsulin (Week 16).|The change between the value of fasting proinsulin collected at week 16 and fasting proinsulin collected at baseline.|Baseline and Week 16.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a proinsulin measurement at baseline and at Week 16. Missing data are imputed using last observation carried forward (LOCF).||pmol/L||Standard Error|Least Squares Mean
718119|NCT00286442|Secondary|Change From Baseline in Fasting Proinsulin (Week 12).|The change between the value of fasting proinsulin collected at week 12 and fasting proinsulin collected at baseline.|Baseline and Week 12.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a proinsulin measurement at baseline and at Week 12. Missing data are imputed using last observation carried forward (LOCF).||pmol/L||Standard Error|Least Squares Mean
718120|NCT00286442|Secondary|Change From Baseline in Fasting Proinsulin (Week 8).|The change between the value of fasting proinsulin collected at week 8 and fasting proinsulin collected at baseline.|Baseline and Week 8.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a proinsulin measurement at baseline and at Week 8. Missing data are imputed using last observation carried forward (LOCF).||pmol/L||Standard Error|Least Squares Mean
718121|NCT00286442|Secondary|Change From Baseline in Fasting Proinsulin (Week 4).|The change between the value of fasting proinsulin collected at week 4 and fasting proinsulin collected at baseline.|Baseline and Week 4.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a fasting plasma glucose measurement at baseline and at Week 4. Missing data are imputed using last observation carried forward (LOCF).||pmol/L||Standard Error|Least Squares Mean
718122|NCT00286442|Secondary|Number of Participants Requiring Rescue.|The number of participants requiring rescue for failing to achieve pre-specified glycemic targets during the 26 week study.|26 Weeks.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who completed at least 1 study visit after baseline.||participants|||Number
718123|NCT00286442|Secondary|Number of Participants With Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg Per dL).|The number of participants with a fasting plasma glucose value greater than or equal to 200 mg per dL during the 26 week study.|26 Weeks.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had at least 1 fasting plasma glucose measurement after baseline.||participants|||Number
718124|NCT00286442|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 26).|The change between the value of fasting plasma glucose collected at week 26 or final visit and fasting plasma glucose collected at baseline.|Baseline and Week 26.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a fasting plasma glucose measurement at baseline and at Week 26. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
718125|NCT00286442|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 20).|The change between the value of fasting plasma glucose collected at week 20 and fasting plasma glucose collected at baseline.|Baseline and Week 20.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a fasting plasma glucose measurement at baseline and at Week 20. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
718126|NCT00286442|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 16).|The change between the value of fasting plasma glucose collected at week 16 and fasting plasma glucose collected at baseline.|Baseline and Week 16.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a fasting plasma glucose measurement at baseline and at Week 16. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
718127|NCT00286442|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 12).|The change between the value of fasting plasma glucose collected at week 12 and fasting plasma glucose collected at baseline.|Baseline and Week 12.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a fasting plasma glucose measurement at baseline and at Week 12. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
718128|NCT00286442|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 8).|The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline.|Baseline and Week 8.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a fasting plasma glucose measurement at baseline and at Week 8. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
718129|NCT00286442|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 4).|The change between the value of fasting plasma glucose collected at week 4 and fasting plasma glucose collected at baseline.|Baseline and Week 4.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a fasting plasma glucose measurement at baseline and at Week 2. Missing data imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
718130|NCT00286442|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 2).|The change between the value of fasting plasma glucose collected at week 2 and fasting plasma glucose collected at baseline.|Baseline and Week 2.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a fasting plasma glucose measurement at baseline and at Week 2.||mg/dL||Standard Error|Least Squares Mean
718131|NCT00286442|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 1).|The change between the value of fasting plasma glucose collected at final visit or week 1 and fasting plasma glucose collected at baseline.|Baseline and Week 1.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a fasting plasma glucose measurement at baseline and at Week 1.||mg/dL||Standard Error|Least Squares Mean
718132|NCT00286442|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 20).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 20 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 20.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had an HbA1c measurement at baseline and at Week 20.||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
718133|NCT00286442|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 16).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 16 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 16.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had an HbA1c measurement at baseline and at Week 16.||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
718134|NCT00286442|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 12).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 12.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had an HbA1c measurement at baseline and at Week 12.||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
718135|NCT00286442|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 8).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 8.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had an HbA1c measurement at baseline and at Week 8.||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
718136|NCT00286442|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 4).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 4 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 4.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had an HbA1c measurement at baseline and at Week 4. Missing data are imputed using last observation carried forward (LOCF).||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
718137|NCT00286442|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26.|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 26 or final visit and glycosylated hemoglobin collected at baseline.|Baseline and Week 26.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had an HbA1c measurement at baseline and at Week 26.||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
718138|NCT00286455|Secondary|Change From Baseline in Glucagon (Week 26).|The change between the value of glucagon collected at week 26 or final visit and glucagon collected at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||pg/mL||Standard Deviation|Mean
718139|NCT00286455|Secondary|Change From Baseline in Glucagon (Week 20).|The change between the value of glucagon collected at week 20 and glucagon collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||pg/mL||Standard Deviation|Mean
718140|NCT00286455|Secondary|Change From Baseline in Glucagon (Week 16).|The change between the value of glucagon collected at week 16 and glucagon collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||pg/mL||Standard Deviation|Mean
719076|NCT00279201|Secondary|INITIATION: Incremental Change From Baseline in Body Weight||Baseline (Initiation), Weeks 6, 12, 18, 24, Endpoint (LOCF)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.||kilograms (kg)||Standard Deviation|Mean
718141|NCT00286455|Secondary|Change From Baseline in Glucagon (Week 12).|The change between the value of glucagon collected at week 12 and glucagon collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||pg/mL||Standard Deviation|Mean
718142|NCT00286455|Secondary|Change From Baseline in Glucagon (Week 8).|The change between the value of glucagon collected at week 8 and glucagon collected at baseline.|Baseline and Week 8.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).) Smaller n at earlier timepoints due to unavailable prior values to carry forward."||pg/mL||Standard Deviation|Mean
718143|NCT00286455|Secondary|Change From Baseline in Glucagon (Week 4).|The change between the value of glucagon collected at week 4 and glucagon collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."||pg/mL||Standard Deviation|Mean
718144|NCT00286455|Secondary|Change From Baseline in Body Weight (Week 26).|The change between Body Weight measured at week 26 or final visit and Body Weight measured at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||kg||Standard Error|Least Squares Mean
718145|NCT00286455|Secondary|Change From Baseline in Body Weight (Week 20).|The change between Body Weight measured at week 20 and Body Weight measured at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||kg||Standard Error|Least Squares Mean
718146|NCT00286455|Secondary|Change From Baseline in Body Weight (Week 12).|The change between Body Weight measured at week 12 and Body Weight measured at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||kg||Standard Error|Least Squares Mean
718147|NCT00286455|Secondary|Change From Baseline in Body Weight (Week 8).|The change between Body Weight measured at week 8 and Body Weight measured at baseline.|Baseline and Week 8.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoint due to unavailable prior values to carry forward"||kg||Standard Error|Least Squares Mean
718148|NCT00286455|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 2.0%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 2.0% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).||participants|||Number
718149|NCT00286455|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.5%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.5% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).||participants|||Number
718150|NCT00286455|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.0%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.0% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).||participants|||Number
718151|NCT00286455|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 0.5%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 0.5% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).||participants|||Number
718152|NCT00286455|Secondary|Number of Participants With Glycosylated Hemoglobin ≤ 7.5%.|The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 7.5% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).||participants|||Number
718153|NCT00286455|Secondary|Number of Participants With Glycosylated Hemoglobin ≤ 7.0%.|The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 7.0% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).||participants|||Number
718154|NCT00286455|Secondary|Number of Participants With Glycosylated Hemoglobin ≤ 6.5%.|The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 6.5% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).||participants|||Number
718155|NCT00286455|Secondary|Change From Baseline in C-peptide (Week 26).|The change between the value of C-peptide collected at week 26 or final visit and C-peptide collected at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||ng/mL||Standard Error|Least Squares Mean
718156|NCT00286455|Secondary|Change From Baseline in C-peptide (Week 20).|The change between the value of C-peptide collected at week 20 and C-peptide collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||ng/mL||Standard Error|Least Squares Mean
718157|NCT00286455|Secondary|Change From Baseline in C-peptide (Week 16).|The change between the value of C-peptide collected at week 16 and C-peptide collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||ng/mL||Standard Error|Least Squares Mean
718158|NCT00286455|Secondary|Change From Baseline in C-peptide (Week 12).|The change between the value of C-peptide collected at week 12 and C-peptide collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||ng/mL||Standard Error|Least Squares Mean
718159|NCT00286455|Secondary|Change From Baseline in C-peptide (Week 8).|The change between the value of C-peptide collected at week 8 and C-peptide collected at baseline.|Baseline and Week 8.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."||ng/mL||Standard Error|Least Squares Mean
718160|NCT00286455|Secondary|Change From Baseline in C-peptide (Week 4).|The change between the value of C-peptide collected at week 4 and C-peptide collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."||ng/mL||Standard Error|Least Squares Mean
718161|NCT00286455|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 26).|The change between the ratio value of proinsulin and insulin collected at week 26 or final visit and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||ratio||Standard Error|Least Squares Mean
718162|NCT00286455|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 20).|The change between the ratio value of proinsulin and insulin collected at week 20 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||ratio||Standard Error|Least Squares Mean
718163|NCT00286455|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 16).|The change between the ratio value of proinsulin and insulin collected at week 16 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||ratio||Standard Error|Least Squares Mean
718164|NCT00286455|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 12).|The change between the ratio value of proinsulin and insulin collected at week 12 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||ratio||Standard Error|Least Squares Mean
718165|NCT00286455|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 8).|The change between the ratio value of proinsulin and insulin collected at week 8 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 8.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."||ratio||Standard Error|Least Squares Mean
718166|NCT00286455|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 4).|The change between the ratio value of proinsulin and insulin collected at week 4 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward"||ratio||Standard Error|Least Squares Mean
718167|NCT00286455|Secondary|Change From Baseline in Insulin (Week 26).|The change between the value of insulin collected at week 26 and insulin collected at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||ϻIU/mL||Standard Error|Least Squares Mean
718168|NCT00286455|Secondary|Change From Baseline in Insulin (Week 20).|The change between the value of insulin collected at week 20 and insulin collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||ϻIU/mL||Standard Error|Least Squares Mean
718169|NCT00286455|Secondary|Change From Baseline in Insulin (Week 16).|The change between the value of insulin collected at week 16 and insulin collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||ϻIU/mL||Standard Error|Least Squares Mean
718170|NCT00286455|Secondary|Change From Baseline in Insulin (Week 12).|The change between the value of insulin collected at week 12 and insulin collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||ϻIU/mL||Standard Error|Least Squares Mean
718171|NCT00286455|Secondary|Change From Baseline in Insulin (Week 8).|The change between the value of insulin collected at week 8 and insulin collected at baseline.|Baseline and Week 8.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."||ϻIU/mL||Standard Error|Least Squares Mean
718172|NCT00286455|Secondary|Change From Baseline in Insulin (Week 4).|The change between the value of insulin collected at week 4 and insulin collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."||ϻIU/mL||Standard Error|Least Squares Mean
718173|NCT00286455|Secondary|Change From Baseline in Fasting Proinsulin (Week 26).|The change between the value of fasting proinsulin collected at week 26 or final visit and fasting proinsulin collected at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||pmol/L||Standard Error|Least Squares Mean
718174|NCT00286455|Secondary|Change From Baseline in Fasting Proinsulin (Week 20).|The change between the value of fasting proinsulin collected at week 20 and fasting proinsulin collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||pmol/L||Standard Error|Least Squares Mean
718175|NCT00286455|Secondary|Change From Baseline in Fasting Proinsulin (Week 16).|The change between the value of fasting proinsulin collected at week 16 and fasting proinsulin collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||pmol/L||Standard Error|Least Squares Mean
718176|NCT00286455|Secondary|Change From Baseline in Fasting Proinsulin (Week 12).|The change between the value of fasting proinsulin collected at week 12 and fasting proinsulin collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||pmol/L||Standard Error|Least Squares Mean
718177|NCT00286455|Secondary|Change From Baseline in Fasting Proinsulin (Week 8).|The change between the value of fasting proinsulin collected at week 8 and fasting proinsulin collected at baseline.|Baseline and Week 8.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward"||pmol/L||Standard Error|Least Squares Mean
718178|NCT00286455|Secondary|Change From Baseline in Fasting Proinsulin (Week 4).|The change between the value of fasting proinsulin collected at week 4 and fasting proinsulin collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."||pmol/L||Standard Error|Least Squares Mean
718179|NCT00286455|Secondary|Number of Participants Requiring Rescue.|The number of participants requiring rescue for failing to achieve pre-specified glycemic targets during the 26 week study.|26 Weeks.|Randomized participants who received at least one dose of study drug (Full Analysis Set).||participants|||Number
718180|NCT00286455|Secondary|Number of Participants With Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg Per dL).|The number of participants with a fasting plasma glucose value greater than or equal to 200 mg per dL at any measurement time point during the 26 week study.|26 Weeks.|Randomized participants who received at least one dose of study drug (Full Analysis Set)and had at least 1 post-baseline FPG measurement.||participants|||Number
718181|NCT00286455|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 26).|The change between the value of fasting plasma glucose collected at week 26 or final visit and fasting plasma glucose collected at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
718182|NCT00286455|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 20).|The change between the value of fasting plasma glucose collected at week 20 and fasting plasma glucose collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
718183|NCT00286455|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 16).|The change between the value of fasting plasma glucose collected at week 16 and fasting plasma glucose collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
718184|NCT00286455|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 12).|The change between the value of fasting plasma glucose collected at week 12 and fasting plasma glucose collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
718185|NCT00286455|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 8).|The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline.|Baseline and Week 8.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."||mg/dL||Standard Error|Least Squares Mean
718186|NCT00286455|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 4).|The change between the value of fasting plasma glucose collected at week 4 and fasting plasma glucose collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward"||mg/dL||Standard Error|Least Squares Mean
718187|NCT00286455|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 2).|The change between the value of fasting plasma glucose collected at week 2 and fasting plasma glucose collected at baseline.|Baseline and Week 2.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."||mg/dL||Standard Error|Least Squares Mean
718188|NCT00286455|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 1).|The change between the value of fasting plasma glucose collected at final visit or week 1 and fasting plasma glucose collected at baseline.|Baseline and Week 1.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."||mg/dL||Standard Error|Least Squares Mean
718189|NCT00286455|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 20).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 20 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
718190|NCT00286455|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 16).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 16 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
718191|NCT00286455|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 12).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
718192|NCT00286455|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 8).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 8.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
718193|NCT00286455|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 4).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 4 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
718194|NCT00286455|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26.|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 26 or final visit and glycosylated hemoglobin collected at baseline.|Baseline and Week 26.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at the week 26 visit. Missing data are imputed using last observation carried forward (LOCF).||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
718195|NCT00286468|Secondary|Change From Baseline in Body Weight (Week 26).|The change between Body Weight measured at week 26 or final visit and Body Weight measured at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||kg||Standard Error|Least Squares Mean
718196|NCT00286468|Secondary|Change From Baseline in Body Weight (Week 20).|The change between Body Weight measured at week 20 and Body Weight measured at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||kg||Standard Error|Least Squares Mean
718197|NCT00286468|Secondary|Change From Baseline in Body Weight (Week 12).|The change between Body Weight measured at week 12 and Body Weight measured at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||kg||Standard Error|Least Squares Mean
718198|NCT00286468|Secondary|Change From Baseline in Body Weight (Week 8).|The change between Body Weight measured at week 8 and Body Weight measured at baseline.|Baseline and Week 8.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||kg||Standard Error|Least Squares Mean
718199|NCT00286468|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 2.0%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 2.0% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).||participants|||Number
719205|NCT00294684|Secondary|Total Bilirubin Concentration at 24 Months of Age||At 24 Months of Age|Intent to treat patients with 24 month bilirubin available are analyzed. There are no imputations for unobserved data. Patients with missing data are simply not included.||mg/dL||Standard Deviation|Mean
718200|NCT00286468|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.5%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.5% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).||participants|||Number
718201|NCT00286468|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.0%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.0% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).||participants|||Number
718202|NCT00286468|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 0.5%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 0.5% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).||participants|||Number
718203|NCT00286468|Secondary|Number of Participants With Glycosylated Hemoglobin ≤ 7.5%.|The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 7.5% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).||participants|||Number
718204|NCT00286468|Secondary|Number of Participants With Glycosylated Hemoglobin ≤ 7.0%.|The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 7.0% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).||participants|||Number
718205|NCT00286468|Secondary|Number of Participants With Glycosylated Hemoglobin ≤ 6.5%.|The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 6.5% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).||participants|||Number
718206|NCT00286468|Secondary|Change From Baseline in C-peptide (Week 26).|The change between the value of C-peptide collected at week 26 or final visit and C-peptide collected at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||ng/mL||Standard Error|Least Squares Mean
718207|NCT00286468|Secondary|Change From Baseline in C-peptide (Week 20).|The change between the value of C-peptide collected at week 20 and C-peptide collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||ng/mL||Standard Error|Least Squares Mean
718208|NCT00286468|Secondary|Change From Baseline in C-peptide (Week 16).|The change between the value of C-peptide collected at week 16 and C-peptide collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||ng/mL||Standard Error|Least Squares Mean
718209|NCT00286468|Secondary|Change From Baseline in C-peptide (Week 12).|The change between the value of C-peptide collected at week 12 and C-peptide collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||ng/mL||Standard Error|Least Squares Mean
718210|NCT00286468|Secondary|Change From Baseline in C-peptide (Week 8).|The change between the value of C-peptide collected at week 8 and C-peptide collected at baseline.|Baseline and Week 8.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."||ng/mL||Standard Error|Least Squares Mean
718211|NCT00286468|Secondary|Change From Baseline in C-peptide (Week 4).|The change between the value of C-peptide collected at week 4 and C-peptide collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."||ng/mL||Standard Error|Least Squares Mean
718212|NCT00286468|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 26).|The change between the ratio value of proinsulin and insulin collected at week 26 or final visit and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||ratio||Standard Error|Least Squares Mean
718213|NCT00286468|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 20).|The change between the ratio value of proinsulin and insulin collected at week 20 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||ratio||Standard Error|Least Squares Mean
718214|NCT00286468|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 16).|The change between the ratio value of proinsulin and insulin collected at week 16 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||ratio||Standard Error|Least Squares Mean
718258|NCT00286494|Secondary|Change From Baseline in C-peptide (Week 20).|The change between the value of C-peptide collected at week 20 and C-peptide collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||ng/mL||Standard Error|Least Squares Mean
718215|NCT00286468|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 12).|The change between the ratio value of proinsulin and insulin collected at week 12 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||ratio||Standard Error|Least Squares Mean
718216|NCT00286468|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 8).|The change between the ratio value of proinsulin and insulin collected at week 8 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 8.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward"||ratio||Standard Error|Least Squares Mean
718217|NCT00286468|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 4).|The change between the ratio value of proinsulin and insulin collected at week 4 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward"||ratio||Standard Error|Least Squares Mean
718218|NCT00286468|Secondary|Change From Baseline in Insulin (Week 26).|The change between the value of insulin collected at week 26 and insulin collected at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||mcIU/mL||Standard Error|Least Squares Mean
718219|NCT00286468|Secondary|Change From Baseline in Insulin (Week 20).|The change between the value of insulin collected at week 20 and insulin collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||mcIU/mL||Standard Error|Least Squares Mean
718220|NCT00286468|Secondary|Change From Baseline in Insulin (Week 16).|The change between the value of insulin collected at week 16 and insulin collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||mcIU/mL||Standard Error|Least Squares Mean
718221|NCT00286468|Secondary|Change From Baseline in Insulin (Week 12).|The change between the value of insulin collected at week 12 and insulin collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||mcIU/mL||Standard Error|Least Squares Mean
718222|NCT00286468|Secondary|Change From Baseline in Insulin (Week 8).|The change between the value of insulin collected at week 8 and insulin collected at baseline.|Baseline and Week 8.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward"||mcIU/mL||Standard Error|Least Squares Mean
718223|NCT00286468|Secondary|Change From Baseline in Insulin (Week 4).|The change between the value of insulin collected at week 4 and insulin collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward"||mcIU/mL||Standard Error|Least Squares Mean
718224|NCT00286468|Secondary|Change From Baseline in Fasting Proinsulin (Week 26).|The change between the value of fasting proinsulin collected at week 26 or final visit and fasting proinsulin collected at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||pmol/L||Standard Error|Least Squares Mean
718225|NCT00286468|Secondary|Change From Baseline in Fasting Proinsulin (Week 20).|The change between the value of fasting proinsulin collected at week 20 and fasting proinsulin collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||pmol/L||Standard Error|Least Squares Mean
718226|NCT00286468|Secondary|Change From Baseline in Fasting Proinsulin (Week 16).|The change between the value of fasting proinsulin collected at week 16 and fasting proinsulin collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||pmol/L||Standard Error|Least Squares Mean
718227|NCT00286468|Secondary|Change From Baseline in Fasting Proinsulin (Week 12).|The change between the value of fasting proinsulin collected at week 12 and fasting proinsulin collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||pmol/L||Standard Error|Least Squares Mean
718228|NCT00286468|Secondary|Change From Baseline in Fasting Proinsulin (Week 8).|The change between the value of fasting proinsulin collected at week 8 and fasting proinsulin collected at baseline.|Baseline and Week 8.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward"||pmol/L||Standard Error|Least Squares Mean
718259|NCT00286494|Secondary|Change From Baseline in C-peptide (Week 16).|The change between the value of C-peptide collected at week 16 and C-peptide collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||ng/mL||Standard Error|Least Squares Mean
718229|NCT00286468|Secondary|Change From Baseline in Fasting Proinsulin (Week 4).|The change between the value of fasting proinsulin collected at week 4 and fasting proinsulin collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward"||pmol/L||Standard Error|Least Squares Mean
718230|NCT00286468|Secondary|Number of Participants Requiring Rescue.|The number of participants requiring rescue for failing to achieve pre-specified glycemic targets during the 26 week study.|26 Weeks.|Randomized participants who received at least one dose of study drug (Full Analysis Set).||participants|||Number
718231|NCT00286468|Secondary|Number of Participants With Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg Per dL).|The number of participants with a fasting plasma glucose value greater than or equal to 200 mg per dL during the 26 week study.|26 Weeks.|Randomized participants who received at least one dose of study drug (Full Analysis Set) and have at least 1 post-baseline measurement for fasting plasma glucose.||participants|||Number
718232|NCT00286468|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 26).|The change between the value of fasting plasma glucose collected at week 26 or final visit and fasting plasma glucose collected at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
718233|NCT00286468|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 20).|The change between the value of fasting plasma glucose collected at week 20 and fasting plasma glucose collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
718234|NCT00286468|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 16).|The change between the value of fasting plasma glucose collected at week 16 and fasting plasma glucose collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
718235|NCT00286468|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 12).|The change between the value of fasting plasma glucose collected at week 12 and fasting plasma glucose collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
718236|NCT00286468|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 8).|The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline.|Baseline and Week 8.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
718237|NCT00286468|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 4).|The change between the value of fasting plasma glucose collected at week 4 and fasting plasma glucose collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."||mg/dL||Standard Error|Least Squares Mean
718238|NCT00286468|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 2).|The change between the value of fasting plasma glucose collected at week 2 and fasting plasma glucose collected at baseline.|Baseline and Week 2.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).Smaller n at earlier timepoints due to unavailable prior values to carry forward."||mg/dL||Standard Error|Least Squares Mean
718239|NCT00286468|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 1).|The change between the value of fasting plasma glucose collected at final visit or week 1 and fasting plasma glucose collected at baseline.|Baseline and Week 1.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."||mg/dL||Standard Error|Least Squares Mean
718240|NCT00286468|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 20).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 20 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
718241|NCT00286468|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 16).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 16 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
718242|NCT00286468|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 12).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
718307|NCT00286754|Secondary|Change in Systolic Blood Pressure From Baseline to 6 Months||Baseline and 6 months|||mm Hg||95% Confidence Interval|Mean
718243|NCT00286468|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 8).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 8.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
718244|NCT00286468|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 4).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 4 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at week 4 due to unavailable prior value to carry forward."||mg/dL||Standard Error|Least Squares Mean
718245|NCT00286468|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26.|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 26 or final visit and glycosylated hemoglobin collected at baseline.|Baseline and Week 26.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
718246|NCT00286494|Secondary|Change From Baseline in Body Weight (Week 26).|The change between Body Weight measured at week 26 or final visit and Body Weight measured at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||kg||Standard Error|Least Squares Mean
718247|NCT00286494|Secondary|Change From Baseline in Body Weight (Week 20).|The change between Body Weight measured at week 20 and Body Weight measured at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||kg||Standard Error|Least Squares Mean
718248|NCT00286494|Secondary|Change From Baseline in Body Weight (Week 12).|The change between Body Weight measured at week 12 and Body Weight measured at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||kg||Standard Error|Least Squares Mean
718249|NCT00286494|Secondary|Change From Baseline in Body Weight (Week 8).|The change between Body Weight measured at week 8 and Body Weight measured at baseline.|Baseline and Week 8.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."||kg||Standard Error|Least Squares Mean
718250|NCT00286494|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 2.0%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 2.0% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).||participants|||Number
718251|NCT00286494|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.5%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.5% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).||participants|||Number
718252|NCT00286494|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.0%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.0% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).||participants|||Number
718253|NCT00286494|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 0.5%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 0.5% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).||participants|||Number
718254|NCT00286494|Secondary|Number of Participants With Glycosylated Hemoglobin ≤ 7.5%.|The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 7.5% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).||participants|||Number
718255|NCT00286494|Secondary|Number of Participants With Glycosylated Hemoglobin ≤ 7.0%.|The number of participants with a value for the percentage of glycosylated hemoglobin less (the percentage of hemoglobin that is bound to glucose) than or equal to 7.0% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).||participants|||Number
718256|NCT00286494|Secondary|Number of Participants With Glycosylated Hemoglobin ≤ 6.5%.|The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 6.5% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).||participants|||Number
718257|NCT00286494|Secondary|Change From Baseline in C-peptide (Week 26).|The change between the value of C-peptide collected at week 26 or final visit and C-peptide collected at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||ng/mL||Standard Error|Least Squares Mean
718308|NCT00286754|Secondary|Change in Proportion With BP Under Control From Baseline to 6 Months||6 months|||Proportion of participants|||Number
718309|NCT00286754|Primary|Systolic Blood Pressure|Mean systolic Blood Pressure|6 months|||mm Hg||95% Confidence Interval|Mean
718260|NCT00286494|Secondary|Change From Baseline in C-peptide (Week 12).|The change between the value of C-peptide collected at week 12 and C-peptide collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||ng/mL||Standard Error|Least Squares Mean
718261|NCT00286494|Secondary|Change From Baseline in C-peptide (Week 8).|The change between the value of C-peptide collected at week 8 and C-peptide collected at baseline.|Baseline and Week 8.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||ng/mL||Standard Error|Least Squares Mean
718262|NCT00286494|Secondary|Change From Baseline in C-peptide (Week 4).|The change between the value of C-peptide collected at week 4 and C-peptide collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."||ng/mL||Standard Error|Least Squares Mean
718263|NCT00286494|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 26).|The change between the ratio value of proinsulin and insulin collected at week 26 or final visit and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||ratio||Standard Error|Least Squares Mean
718264|NCT00286494|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 20).|The change between the ratio value of proinsulin and insulin collected at week 20 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||ratio||Standard Error|Least Squares Mean
718265|NCT00286494|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 16).|The change between the ratio value of proinsulin and insulin collected at week 16 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||ratio||Standard Error|Least Squares Mean
718266|NCT00286494|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 12).|The change between the ratio value of proinsulin and insulin collected at week 12 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||ratio||Standard Error|Least Squares Mean
718267|NCT00286494|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 8).|The change between the ratio value of proinsulin and insulin collected at week 8 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 8.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||ratio||Standard Error|Least Squares Mean
718268|NCT00286494|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 4).|The change between the ratio value of proinsulin and insulin collected at week 4 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."||ratio||Standard Error|Least Squares Mean
718269|NCT00286494|Secondary|Change From Baseline in Insulin (Week 26).|The change between the value of insulin collected at week 26 and insulin collected at baseline.|Baseline and Week 26.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."||mcIU/mL||Standard Error|Least Squares Mean
718270|NCT00286494|Secondary|Change From Baseline in Insulin (Week 20).|The change between the value of insulin collected at week 20 and insulin collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||mcIU/mL||Standard Error|Least Squares Mean
718271|NCT00286494|Secondary|Change From Baseline in Insulin (Week 16).|The change between the value of insulin collected at week 16 and insulin collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||mcIU/mL||Standard Error|Least Squares Mean
718272|NCT00286494|Secondary|Change From Baseline in Insulin (Week 12).|The change between the value of insulin collected at week 12 and insulin collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||mcIU/mL||Standard Error|Least Squares Mean
718273|NCT00286494|Secondary|Change From Baseline in Insulin (Week 8).|The change between the value of insulin collected at week 8 and insulin collected at baseline.|Baseline and Week 8.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||mcIU/mL||Standard Error|Least Squares Mean
718274|NCT00286494|Secondary|Change From Baseline in Insulin (Week 4).|The change between the value of insulin collected at week 4 and insulin collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."||mcIU/mL||Standard Error|Least Squares Mean
718275|NCT00286494|Secondary|Change From Baseline in Fasting Proinsulin (Week 26).|The change between the value of fasting proinsulin collected at week 26 or final visit and fasting proinsulin collected at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||pmol/L||Standard Error|Least Squares Mean
718276|NCT00286494|Secondary|Change From Baseline in Fasting Proinsulin (Week 20).|The change between the value of fasting proinsulin collected at week 20 and fasting proinsulin collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||pmol/L||Standard Error|Least Squares Mean
718277|NCT00286494|Secondary|Change From Baseline in Fasting Proinsulin (Week 16).|The change between the value of fasting proinsulin collected at week 16 and fasting proinsulin collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||pmol/L||Standard Error|Least Squares Mean
718278|NCT00286494|Secondary|Change From Baseline in Fasting Proinsulin (Week 12).|The change between the value of fasting proinsulin collected at week 12 and fasting proinsulin collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||pmol/L||Standard Error|Least Squares Mean
718279|NCT00286494|Secondary|Change From Baseline in Fasting Proinsulin (Week 8).|The change between the value of fasting proinsulin collected at week 8 and fasting proinsulin collected at baseline.|Baseline and Week 8.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."||pmol/L||Standard Error|Least Squares Mean
718280|NCT00286494|Secondary|Change From Baseline in Fasting Proinsulin (Week 4).|The change between the value of fasting proinsulin collected at week 4 and fasting proinsulin collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."||pmol/L||Standard Error|Least Squares Mean
718281|NCT00286494|Secondary|Number of Participants Requiring Rescue.|The number of participants requiring rescue for failing to achieve pre-specified glycemic targets during the 26 week study.|26 Weeks.|Randomized participants who received at least one dose of study drug (Full Analysis Set)and at least 1 post-baseline measurement.||participants|||Number
718282|NCT00286494|Secondary|Number of Participants With Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg Per dL).|The number of participants with a fasting plasma glucose value greater than or equal to 200 mg per dL during the 26 week study.|26 Weeks.|Randomized participants who received at least one dose of study drug (Full Analysis Set) and had at least 1 post-baseline FPG measurement.||participants|||Number
718283|NCT00286494|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 26).|The change between the value of fasting plasma glucose collected at week 26 or final visit and fasting plasma glucose collected at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
718284|NCT00286494|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 20).|The change between the value of fasting plasma glucose collected at week 20 and fasting plasma glucose collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
718285|NCT00286494|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 16).|The change between the value of fasting plasma glucose collected at week 16 and fasting plasma glucose collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
718286|NCT00286494|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 12).|The change between the value of fasting plasma glucose collected at week 12 and fasting plasma glucose collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
718287|NCT00286494|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 8).|The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline.|Baseline and Week 8.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
718288|NCT00286494|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 4).|The change between the value of fasting plasma glucose collected at week 4 and fasting plasma glucose collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).Smaller n at earlier timepoints due to unavailable prior values to carry forward"||mg/dL||Standard Error|Least Squares Mean
718289|NCT00286494|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 2).|The change between the value of fasting plasma glucose collected at week 2 and fasting plasma glucose collected at baseline.|Baseline and Week 2.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).Smaller n at earlier timepoints due to unavailable prior values to carry forward."||mg/dL||Standard Error|Least Squares Mean
718310|NCT00286754|Primary|Blood Pressure Control|Blood pressure Control at 6 months|6 months|||proportion of participants|||Number
718290|NCT00286494|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 1).|The change between the value of fasting plasma glucose collected at final visit or week 1 and fasting plasma glucose collected at baseline.|Baseline and Week 1.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).Smaller n at earlier timepoints due to unavailable prior values to carry forward."||mg/dL||Standard Error|Least Squares Mean
718291|NCT00286494|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 20).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 20 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
718292|NCT00286494|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 16).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 16 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
718293|NCT00286494|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 12).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
718294|NCT00286494|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 8).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 8.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
718295|NCT00286494|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 4).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 4 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).). Smaller n at earlier timepoints due to unavailable prior values to carry forward."||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
718296|NCT00286494|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26.|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 26 or final visit and glycosylated hemoglobin collected at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
718297|NCT00286728|Secondary|Mental Health Services Use and Costs at 6 Months, 1 Year, and 2 Years||6 months, 1 year, 2 years||||||
718298|NCT00286728|Primary|Psychiatric Functioning at 6 Months|Addiction Severity Index psychiatric composite ranges from 0 to 1, with 1 indicating more severe problems.|6 months|Explanation of Ns discrepant with patient flow: Ns with psychiatric severity scores at 6 months differ from those having completed the study at 2 years.||units on a scale||Standard Deviation|Mean
718299|NCT00286741|Primary|Systolic Blood Pressure||12 months|||mmHg||Standard Deviation|Mean
718300|NCT00286741|Secondary|Cost-effectiveness, Proportion of Patients With LDL < 100, Health Services Utilization, Quality of Life (as Measured by DQoL), Patient Empowerment (as Measured by DES).||one year||||||
718301|NCT00286741|Primary|Hemoglobin A1c||12 months|||percentage points||Standard Deviation|Mean
718302|NCT00286754|Secondary|Medication Stage of Change|The stages of change were: precontemplation, or no plans to adhere in <6 months; contemplation, or plans to adhere in 1-6 months; preparation, or plans to adhere within 1 month; action, or adherence for <6 months; and maintenance, or adherence for ≥ 6 months. Medication adherence was defined as self-report of taking BP medications as prescribed for at least 6 days per week.|6 months|||participants|||Number
718303|NCT00286754|Secondary|Exercise Stage of Change|The stages of change were: precontemplation, or no plans to adhere in <6 months; contemplation, or plans to adhere in 1-6 months; preparation, or plans to adhere within 1 month; action, or adherence for <6 months; and maintenance, or adherence for ≥ 6 months. Exercise adherence was defined as self-reported aerobic exercise for at least 3 days per week for at least 20 minutes each time. We used the lower threshold for exercise adherence due to our patient population with multiple comorbidities, consistent with Federal guidelines for older adults with chronic conditions.|6 months|||participants|||Number
718304|NCT00286754|Secondary|Diet Stage of Change|The stages of change were: precontemplation, or no plans to adhere in <6 months; contemplation, or plans to adhere in 1-6 months; preparation, or plans to adhere within 1 month; action, or adherence for <6 months; and maintenance, or adherence for ≥ 6 months. Patients were considered adherent to diet if they reported eating the appropriate diet for hypertension (low in salt and fat with fruits, vegetables, and low-or non-fat dairy products) at least 6 days per week.|6 months|||participants|||Number
718305|NCT00286754|Secondary|Change in Morisky Score From Baseline to 6 Months|Morkisy medication adherence self-report questionnaire, a 4-item questionnaire scored from 0-4. A score of 4 is considered most adherent, and scores of less than 4 are defined as nonadherent|baseline and 6 months|||units on a scale||95% Confidence Interval|Mean
718306|NCT00286754|Secondary|Change in Number of Cardio Exercise Hours From Baseline to 6 Months||baseline and 6 months|||hours||95% Confidence Interval|Mean
718311|NCT00286949|Primary|Frontal Systems Behavioral Scale (FrSBe) Executive Function Subscore|Frontal Systems Behavioral Scale (FrSBe) Executive Function subscore is on of the 3 subscales of the FrSBE, a scale designed to identify and quantify behavioral problems associated with frontal lobe dysfunction. The other subscales are Apathy and Disinhibition. Each item is rated on a 5-point Likert scale. Totals are generated for each subscale and normative data is referenced (based on patient gender, age and education) and standardized T-scores are determined ), with higher scores representing greater impairment. For all FrSBe scales, T scores ≥ 65 are considered clinically significant and scores of 60 to 64 represent likely borderline impairment.|8 weeks|||T-score||Standard Deviation|Mean
718312|NCT00286949|Primary|Connors Adult Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale-Long Form (CAARS-L) Inattention/Memory Subscale|The CAARS-L Inattention/Memory subscale, a primary self-rated outcome measure in this study, measures the frequency of behaviors associated with executive dysfunction, such as task incompletion, disorganization, distractibility, and difficulty planning, multi-tasking, and initiating tasks. CAARS-L scores are depicted as group Mean (SD) T scores, derived from comparison to CAARS norms based on gender and age in a normative sample. Similar to the FrSBE, higher T-scores are associated with greater symptom severity and T-scores above 65 represent symptoms of clinical significance.|baseline and 8 weeks|||units on a scale||Standard Deviation|Mean
718313|NCT00286949|Primary|Clinical Global Impression of Change-Clinician Rated Score (CGIC-C)|"CGIC-C score is a clinician's rating of change (improvement or worsening) over the course of the trial in an individual's symptoms and their global impact on function and clinical status, i.e., the global impact of the intervention that the patient is better, unchanged, or worse). Scale ranges1 to 7 which equates to from very much worse to very much improved.
The CGIC-C score is not an appropriate baseline measure since it represents change after initiating an intervention. In addition, a baseline Clinical Global Impression of Severity-Clinician Rated Score (CGIS-C) is not appropriate to compare to CGIC-C, as a patient with severe disease might show clinically meaningful improvement (i.e., very much improved) from an intervention while still being severely affected on the CGIS-C score; by contrast, a patient with mild CGIS-C could have minimal or no change on the CGIC-C score. This study was not designed to assess the influence of disease severity on the primary outcome (CGIC-C)."|8 weeks|||Participants|||Count of Participants
718314|NCT00287053|Secondary|Association of Change With a Behavioral Phenotype.||February 2006 to September 2006||||||
718315|NCT00287053|Secondary|Endocrine Response.||February 2006 to September 2006||||||
718316|NCT00287053|Secondary|Change in Body Weight.||February 2006 to September 2006||||||
718317|NCT00287053|Secondary|Change in Posture Allocation and Energy Expenditure.||February 2006 to September 2006||||||
718318|NCT00287053|Primary|Change in Food Intake.|Change in food intake from baseline to week 3.|February 2006 to September 2006|||kcal||Standard Error|Least Squares Mean
718319|NCT00287079|Primary|Time in Month to Clinical Definite Multiple Sclerosis (CDMS) From Kaplan-Meier Estimates|CDMS was defined by the occurrence of a second exacerbation or relapse over 96 weeks in participants who presented with Clinically Isolated Syndrome (CIS) accompanied by an abnormal Magnetic Resonance Imaging (MRI) scan. Time was calculated from the date of the stabilization of the baseline CIS episode to the qualifying relapse for the CDMS.|Up to Week 96|Intent-to-treat (ITT) population: All participants in Treatment group who received at least 1 dose of Rebif® and all participants in observational group who had at least 1 post-baseline visit were included in ITT population. Two participants had negative time from stabilization and CDMS relapse and were excluded from the Kaplan-Meier analysis.||Month||Standard Error|Mean
718320|NCT00287079|Secondary|Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)|AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition.|Up to Week 96|"Intent-to-treat (ITT) population: All participants in Treatment group who received at least 1 dose of Rebif® and all participants in observational group who had at least 1 post-baseline visit were included in ITT population. Adverse events were not captured for No Treatment group."||percentage of participants|||Number
718321|NCT00287079|Secondary|Percentage of Participants Who Converted to Clinical Definite Multiple Sclerosis (CDMS)|CDMS was defined as the occurrence of a second exacerbation over 96 weeks in participants who presented with CIS accompanied by an abnormal MRI scan.|Up to Week 96|Intent-to-treat (ITT) population: All participants in Treatment group who received at least 1 dose of Rebif® and all participants in observational group who had at least 1 post-baseline visit were included in ITT population.||Percentage of participants|||Number
718322|NCT00287222|Primary|Number of Participants Who Remained Free of Progression at the 27th Week.||27 weeks|Per protocol||participants|||Number
718323|NCT00287339|Primary|Change in Cough-Specific Quality of Life Questionnaire|It is a validated, 28-item assessment tool designed to evaluate decrements in quality of life due to chronic cough. This questionnaire measures cough-related symptoms, as well as the social implications and psychological impact. Examples of items include, “I cannot sleep at night” and “I cough and it makes me retch.” The final score is obtained by summing the responses to 28 questions, each scored on a 1-4 scale, where 1 is “strongly disagree,” and 4 is “strongly agree.” The minimum and maximum CQLQ scores are 28 and 112 respectively, with increasing score indicating more severe impairment.|baseline and 12 weeks|||participants||Standard Deviation|Mean
718372|NCT00280059|Secondary|Mean Monthy Seizure Frequency: All Seizures|Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Month of time = number of months after Week 4 (Dose Escalation).|Baseline up to Week 60|FAS. N = number of participants with analyzable data; n = number of participants with analyzable data at observation.||seizures/28 days||Standard Deviation|Mean
718327|NCT00287586|Secondary|Change in Health Quality of Life (QoL) as Assessed by Short Form 36 (SF-36)|The SF-36 measures 8 domains of the QoL: physical function, bodily pain, vitality, role limitations due to physical problems, general health perceptions, emotional well-being, social function, and role limitations due to emotional problems. Each domain is scored separately from 0 to 100 with higher scores representing better health-related QoL. The Overall Score is the average of the individual domain scores. A negative change from Baseline indicates improvement.|Baseline and Month 36|All participants from the Intent-to-treat population, all randomized and treated participants, with data available at the given time-point.||score on a scale||Standard Deviation|Mean
718328|NCT00287586|Secondary|Change in Sexual Function as Assessed by the International Index of Erectile Function (IIEF)|IIEF is a validated, 15-item questionnaire that assesses 5 domains of sexual function: erectile function (6 questions), orgasmic function (2 questions), sexual desire (2 questions), intercourse satisfaction (3 questions), and overall sexual satisfaction (2 questions). Each question was answered on a 5-point scale from 1 to 5 (best) with a total possible score range of 0 to 75 with higher scores representing better function. A positive change from Baseline indicates improvement.|Baseline and Month 36|All participants from the Intent-to-treat population, all randomized and treated participants, with data available at the given time-point.||score on a scale||Standard Deviation|Mean
718329|NCT00287586|Secondary|Change From Baseline in Unloaded Stair Climb Power and Loaded Stair Climb Power|Physical Function was evaluated using two tests of stair climb power using an indoor 12-step staircase. One test consisted of ascending the 12-steps as rapidly as possible without running (unloaded stair climb) while the second test required participants to carry a load equivalent to 20% of their baseline body weight evenly distributed in two canvas tote bags (loaded stair climb). Time to ascend the stairs was measured electronically with a digital clock and switch mats placed at the base of the steps and on the 12th step. Power in watts is calculated by the following: [body weight (kilograms) * distance (meters)/ (time/60)] /6.12. A negative change from Baseline indicates improvement.|Baseline and Month 36|All participants from the Intent-to-treat population, all randomized and treated participants, with baseline physical function data and data available at the given time-point.||watts||Standard Deviation|Mean
718330|NCT00287586|Secondary|Change From Baseline in Chest Press Strength and Leg Press Strength|Maximal voluntary strength of the lower and upper extremities was assessed using the one repetition maximum (1-RM) method for the seated leg press and chest press exercises. Participants were positioned with standardized seat position and foot placement that allowed 90° of knee flexion for the leg press exercise. Seat height and handle position was standardized for the chest press. Participants were familiarized with the exercises, practiced the technique and completed a 5-minute warm-up. The 1-RM procedure consisted of a warm up set with 5 to 8 repetitions at a resistance set to about 50% of the participant’s estimated 1-RM and progressed with increasing loads interspersed with standardized rest periods until the participant was able to perform only one full-range-of-motion repetition.|Baseline and Month 36|All participants from the Intent-to-treat population, all randomized and treated participants, with baseline physical function data and data available at the given time-point.||newton||Standard Deviation|Mean
718331|NCT00287586|Secondary|Change From Baseline in the Trail Making Test B|Cognitive function was assessed by the Trail Making Test B. Trail Making Test B involved participants connecting numbers (1–13) and letters (A–L) alternately (1–A, 2–B, etc) on a piece of paper as quickly as possible. Scores represent the time it takes the participant to complete the test. Less time is best and a negative change from Baseline indicates improvement. A positive change from Baseline indicates a worsening.|Baseline and Month 36|All participants from the Intent-to-treat population, all randomized and treated participants, with cognitive baseline data and data available at the given time-point.||seconds||Standard Deviation|Mean
718332|NCT00287586|Secondary|Change From Baseline in the Stroop Interference Test|Cognitive function was assessed by the Stroop Interference Test. In the Stroop Interference Test, participants were presented with a word list of colors printed in ink of a color different from how the printed word read. Participants were instructed to read aloud the color of the ink in which a word was printed, while not verbalizing the word itself. The time in seconds that the items were correctly identified was recorded. Less time is better and a negative change from Baseline indicates improvement.|Baseline and Month 36|All participants from the Intent-to-treat population, all randomized and treated participants, with cognitive baseline data and data available at the given time-point.||seconds||Standard Deviation|Mean
718333|NCT00287586|Secondary|Change From Baseline in the Category Fluency Test|Cognitive function was assessed by the Category Fluency Test. Participants were asked to name as many items from a given category as possible. Higher number of items named is best and a positive change from Baseline indicates improvement.|Baseline and Month 36|All participants from the Intent-to-treat population, all randomized and treated participants, with cognitive baseline data and data available at the given time-point.||items||Standard Deviation|Mean
718334|NCT00287586|Secondary|Change From Baseline in the Verbal Fluency Test|Cognitive function was assessed by the Verbal Fluency Test. Participants were asked to name as many letters from a given category as possible in 1 minute. Higher number of letters is best and a positive change from Baseline indicates improvement.|Baseline and Month 36|All participants from the Intent-to-treat population, all randomized and treated participants, with cognitive baseline data and data available at the given time-point.||letters||Standard Deviation|Mean
718335|NCT00287586|Secondary|Change From Baseline in the Buschke Selective Reminding Test (Delayed)|Cognitive function was assessed by the Buschke Selective Reminding Test. In the Buschke Selective Reminding Test, participants were read 12 words and asked to recall as many words as possible. Subsequent trials included only those words that were not recalled in the preceding trial. Individuals were also asked to recall the list 30 minutes later. To assess phonemic and category fluency, participants were asked to name as many items from a given category as possible in 1 minute. Higher number of correct items is best and a positive change from Baseline indicates improvement.|Baseline and Month 36|All participants from the Intent-to-treat population, all randomized and treated participants, with cognitive baseline data and data available at the given time-point.||correct items||Standard Deviation|Mean
718513|NCT00281580|Secondary|Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP|Observed results - key combination therapies|End-of-study (up to 8 weeks) visit (LOCF)|FAS-ABPM: all patients of the FAS that participated in the ambulatory blood pressure monitoring (ABPM) sub-study and had a successful APBM at both baseline and following treatment with target therapy.||mmHg||Standard Deviation|Mean
718336|NCT00287586|Secondary|Change From Baseline in Paragraph Recall Test (Delayed)|Cognitive Function was assessed by the Paragraph Recall Test (Delayed). In the Paragraph Recall Test, participants were read two short paragraphs and asked to recall them immediately and after a 30 minute delay, using the exact words that were read aloud. Scoring was based on the number of items correctly recalled. More items correctly recalled is best and a positive change from Baseline indicates improvement.|Baseline and Month 36|All participants from the Intent-to-treat population, all randomized and treated participants, with cognitive baseline data and data available at the given time-point.||correct items||Standard Deviation|Mean
718337|NCT00287586|Secondary|Change From Baseline in Complex Figure (Immediate) and Complex Figure (Delayed)|Cognitive Function was assessed by Complex Figure (Immediate) and (Delayed). The Complex Figure Test consists of three tasks: copy, immediate recall, and delayed recall. Participants were presented with a complex design and then asked to draw the same figure. Subsequently, they were instructed to draw what they remembered immediately, and after a 30 minute delay. Scoring was based on the number of correct items for a total possible score of 0 (worst) to 36 (Best). A positive change from Baseline indicates improvement. A negative change from Baseline indicates a worsening.|Baseline and Month 36|All participants from the Intent-to-treat population, all randomized and treated participants, with cognitive baseline data and data available at the given time-point.||correct items||Standard Deviation|Mean
718338|NCT00287586|Secondary|Changes in Blood Pressure||Three years|No analysis was performed. Although blood pressure measurements were standardized within a trial site, there is a possibility that measurement techniques might have varied across the three trial sites over the trial’s long duration. For this reason we decided not to include blood pressure data in the results.|||||
718339|NCT00287586|Secondary|Changes in Biomarkers of Inflammation||Three years|No analysis was performed. No funds were left to cover the costs of the assays for inflammation biomarkers.|||||
718340|NCT00287586|Secondary|Change From Baseline in Lipid Profiles|Laboratory tests included in the lipid profile were Total Cholesterol, High Density Lipoprotein-Cholesterol (HDL-C), Low Density Lipoprotein-Cholesterol (LDL-C) and Triglycerides.Lower values for Total Cholesterol, LDL-C are better and a negative change from Baseline indicates improvement. Higher values for HDL-C are better and a positive change from Baseline indicates improvement.|Baseline and Month 36|All participants from the Intent-to-treat population, all randomized and treated participants, with data available at the given time-point.||mg/dL||Standard Deviation|Mean
718341|NCT00287586|Primary|Change From Baseline in Coronary Artery Calcium Score|A multiple detector computed tomography (MDCT) scan was performed. Proximal coronary arteries were visualized, and at least 30 consecutive images were obtained at 3-mm intervals. Coronary calcium was defined as a plaque of at least 3 contiguous pixels (area, 1.02 mm^2) with a density of more than 130 Hounsfield units.The lesion score was calculated by multiplying lesion area by a density factor derived from Hounsfield units. The Agatston method was used to determine the total calcium score by summing the lesion scores from the left main, left anterior descending, circumflex, and right coronary arteries. The Agatston score is the measure of calcification in arteries expressed on continuous scale with “0” value (better) indicating no calcification and score above 400 (worse) indicating high calcification. There is no upper limit for this measure. A positive change from baseline indicates a worsening.|Baseline and Month 36|All participants from the Intent-to-treat population, all randomized and treated participants, with data available at the given time-point.||score on a scale||Standard Deviation|Mean
718342|NCT00287586|Primary|Change From Baseline in Common Carotid Artery Intima-Media Thickness (IMT)|B-mode carotid artery images for IMT were acquired from the far wall of the distal centimeter of the right carotid artery with high-resolution ultrasound equipment. IMT is used as a predictor of the incidence of cardiovascular events. An increase in the IMT thickness is associated with a higher incidence of cardiovascular events. Less thickening is best. Change is expressed in millimeters (mm).|Baseline and Month 36|All participants from the Intent-to-treat population, all randomized and treated participants, with data available at the given time-point.||mm||Standard Deviation|Mean
718343|NCT00279591|Secondary|Amount of Intravenous Fluid Resuscitation||At start of inter-facility transport, then every 15 minutes until arrival.|||ml/kg||Standard Deviation|Mean
718344|NCT00279591|Secondary|Mean Daily Score Using the Therapeutic Intervention Scoring System (TISS-28) Scale.|The Therapeutic Intervention Scoring System (TISS-28) is an illness severity score for the ICU. The TISS score can range from zero up to 78. The higher the score is, the more severe the illness. The TISS-28 scale measures the severity of a patient's illness.|Up to two weeks|This is the total number of participants analyzed for the intervention group and the control group and the total number of days analyzed overall for the intervention group and the control group.||units on a scale|Participants|Standard Deviation|Mean
718345|NCT00279591|Secondary|Total Number of Organ Failure Days (Multiple Organ Dysfunction) in the Intensive Care Unit (ICU)for the Control Group and Total Number of Organ Failure Days for the Intervention Group. Multiple Organ Dysfunction is Defined as Multiple Organ Failure.|Total number of organ failure days is for each group as a whole.|Up to two weeks|ITT||Days|Participants||Number
718346|NCT00279591|Secondary|Intensive Care Unit (ICU) Length of Stay||Up to two weeks|||days||Standard Deviation|Mean
718347|NCT00279591|Primary|The Difference in Hospital Length of Stay Between Those Who Received Continuous Blood Pressure Monitoring and Those Who Received Standard of Care|This is the total number of participants analyzed for the intervention group and the total number of participants analyzed for the control group and the total number of days that each group was analyzed overall.|Up to two weeks|Intention to Treat||days||Standard Deviation|Mean
718348|NCT00279708|Other Pre-specified|Chest Imaging|HRCT Chest radiographs|12 month treatment period||09/2018||||
718349|NCT00279708|Secondary|Quality of Life and Dyspnea Scales|St. George's Respiratory Questionnaire SF-36 Modified MRC Dyspnea Scale|12 month treatment period||09/2017||||
718350|NCT00279708|Secondary|Exercise Performance|Cardiopulmonary Exercise Tests (VO2 peak, VO2/work, VECO2) Six minute Walk Test (distance, Borg scale)|12 month treatment period||09/2017||||
718351|NCT00279708|Secondary|Pulmonary Function Tests|Spirometry measurements (FVC and FEV1) obtained post-bronchodilator Diffusion, adjusted for hemoglobin|12 month treatment period||09/2017||||
719206|NCT00294684|Secondary|Total Bilirubin Concentration at 12 Months||12 Months post HPE|Intent to treat patients with 12 month bilirubin available are analyzed. There are no imputations for unobserved data. Patients with missing data are simply not included.||mg/dL||Standard Deviation|Mean
718352|NCT00279708|Secondary|Pulmonary Sarcoidosis Flares|Flare rates and relative risk: Flares (relapses) were defined as the physiological deterioration in pulmonary function due to worsened pulmonary inflammation. The criteria used for a pulmonary flare included: > 15% decline in static function (FEV1 post, FVC post); or (> 20% DLCO adj); or a > 15% decline in walk distance as measured by the six minute walk test, or via a decline in oxygen consumption collected during a cardiopulmonary exercise test (CPET). Additional factors considered included an increase in dyspnea (>15% increase in the dyspnea scale (TDI); and/or significant radiographic worsening. Clinical assessment of the patient’s status may have been factored into the criteria for flare determination as well.|1 year||09/2017||||
718353|NCT00279708|Primary|The Steroid Sparing Period|The duration of steroid sparing was defined as the date when the target dose of prednisone was reached until the date at which the dose was increased and/or met the relapse (flare) criteria; or until the 12 month study phase ended if no prednisone dose increase was required. The steroid sparing period was measured in units of days. The prednisone target dose was defined as a 90% reduction of the baseline dose or an absolute prednisone dose of 4 mg/day or less.|1 year|||days||Inter-Quartile Range|Mean
718354|NCT00279916|Secondary|Number of Subjects With Change in Symptom Frequency and Severity - Dampened Hearing/Loss Worse Than Usual|As measured by the Eustachian Tube Dysfunction Questionnaire. The questionnaire had 5 symptoms with a Frequency Rating from 1=Never to 5=Constantly, and Severity rating from 1=None at all to 5=Maximum severity. The change in frequency and severity ratings were categorized as same, better, or worse.|baseline, 6 weeks|Number of participants is based on those who completed the study and who completed a baseline and a follow-up questionnaire. 38 of the subjects randomized to Triamcinolone acetonide nasal spray and 40 of the subjects randomized to placebo had a baseline and follow-up questionnaire at 6 weeks.||participants|||Number
718355|NCT00279916|Secondary|Number of Subjects With Change in Symptom Frequency and Severity - Popping Sensation in Ears|As measured by the Eustachian Tube Dysfunction Questionnaire. The questionnaire had 5 symptoms with a Frequency Rating from 1=Never to 5=Constantly, and Severity rating from 1=None at all to 5=Maximum severity. The change in frequency and severity ratings were categorized as same, better, or worse.|baseline, 6 weeks|Number of participants is based on those who completed the study and who completed a baseline and a follow-up questionnaire. 38 of the subjects randomized to Triamcinolone acetonide nasal spray and 40 of the subjects randomized to placebo had a baseline and follow-up questionnaire at 6 weeks.||participants|||Number
718356|NCT00279916|Secondary|Number of Subjects With Change in Symptom Frequency and Severity - Plugged Sensation in Ears|As measured by the Eustachian Tube Dysfunction Questionnaire. The questionnaire had 5 symptoms with a Frequency Rating from 1=Never to 5=Constantly, and Severity rating from 1=None at all to 5=Maximum severity. The change in frequency and severity ratings were categorized as same, better, or worse.|baseline, 6 weeks|Number of participants is based on those who completed the study and who completed a baseline and a follow-up questionnaire. 38 of the subjects randomized to Triamcinolone acetonide nasal spray and 40 of the subjects randomized to placebo had a baseline and follow-up questionnaire at 6 weeks.||participants|||Number
718357|NCT00279916|Secondary|Number of Subjects With Change in Symptom Frequency and Severity - Pain in Ears|As measured by the Eustachian Tube Dysfunction Questionnaire. The questionnaire had 5 symptoms with a Frequency Rating from 1=Never to 5=Constantly, and Severity rating from 1=None at all to 5=Maximum severity. The change in frequency and severity ratings were categorized as same, better, or worse.|baseline, 6 weeks|Number of participants is based on those who completed the study and who completed a baseline and a follow-up questionnaire. 38 of the subjects randomized to Triamcinolone acetonide nasal spray and 40 of the subjects randomized to placebo had a baseline and follow-up questionnaire at 6 weeks.||participants|||Number
718358|NCT00279916|Secondary|Number of Subjects With Change in Symptom Frequency and Severity - Fullness or Pressure in Ears|As measured by the Eustachian Tube Dysfunction Questionnaire. The questionnaire had 5 symptoms with a Frequency Rating from 1=Never to 5=Constantly, and Severity rating from 1=None at all to 5=Maximum severity. The change in frequency and severity ratings were categorized as same, better, or worse.|baseline, 6 weeks|Number of participants is based on those who completed the study and who completed a baseline and a follow-up questionnaire. 38 of the subjects randomized to Triamcinolone acetonide nasal spray and 40 of the subjects randomized to placebo had a baseline and follow-up questionnaire at 6 weeks.||participants|||Number
718359|NCT00279916|Secondary|Per-Ear Treatment Outcome|Initial Tympanogram Type at baseline was compared to Follow-Up Tympanogram Type at 6 weeks. Type A is considered to be normal. Type A; peaked pressure measurement under -100 kilo Pascals (kPa). Type B; non-peaked, or flat tympanogram, Type C; peaked pressure measurements more negative than -100 kPa. A Pascal is a unit used to quantify internal pressure.|baseline, 6 weeks|Number of participants is based on those who completed the study and who had a follow-up tympanogram. 37 of the subjects randomized to Triamcinolone acetonide nasal spray and 37 of the subjects randomized to placebo had a follow-up tympanogram at 6 weeks.||ears|||Number
718360|NCT00279916|Secondary|Complete Normalization of Abnormal Tympanometry Considering the Subjects Who Took Additional Treatment as Having Incomplete Resolution|For this outcome measure, the subjects treated with antibiotics or oral decongestants while enrolled in the study were handled as having treatment failures. For this outcome measure, subjects with complete normalization of abnormal tympanometry at 6 weeks had a Type A tympanogram and did not take antibiotics, oral decongestants, nasal spray or a combination.|6 weeks|Number of participants is based on those who completed the study and who had a follow-up tympanogram. 37 of the subjects randomized to Triamcinolone acetonide nasal spray and 37 of the subjects randomized to placebo had a follow-up tympanogram at 6 weeks.||participants|||Number
718361|NCT00279916|Primary|Number of Subjects With Complete Normalization of Abnormal Tympanometry, Regardless of Additional Treatment|Number of subjects with resolution of eustachian tube dysfunction symptoms, as determined by the change in tympanogram type in both ears from an initial Type B or C result to Type A result at 6 weeks. Type A; peaked pressure measurement under -100 kilo Pascals (kPa). Type B; non-peaked, or flat tympanogram, Type C; peaked pressure measurements more negative than -100 kPa. A Pascal is a unit used to quantify internal pressure.|6 weeks|Number of participants is based on those who completed the study and who had a follow-up tympanogram. 37 of the subjects randomized to Triamcinolone acetonide nasal spray and 37 of the subjects randomized to placebo had a follow-up tympanogram at 6 weeks.||participants|||Number
718362|NCT00279955|Secondary|Occurrence of Heart Failure (HF) Related Pulmonary Congestion Event (PCE)|Number of participates with HF related pulmonary congestion event will be reported. Time to the first HF related pulmonary cogestion event in the “Follow-up Period” from the 6-month visit to the 12-month visit is compared between two risk groups to see if there is significant difference. A HF related pulmonary congestion event is defined as hospitalization with signs and/or symptoms of pulmonary congestion, or outpatient treatment with IV diuretics due to exacerbation of HF with signs and/or symptoms of pulmonary congestion.|6 month to the 12 month visit|||participants|||Number
718363|NCT00279955|Secondary|Occurrence of Heart Failure (HF) Related Healthcare Utilization (HU)|Number of participates with HF realted healthcare utilization will be reported. Time to the first HF-related healthcare utilization in the “Follow-up Period” from the 6-month visit to the 12-month visit is compared between two risk groups. The goal was to test if there is a significant difference in time to first HF-related healthcare utilization between two groups. A heart failure related (HF-related) healthcare utilization is defined as unscheduled office visits, hospitalizations, urgent care visits, and emergency room visits which is resulted by heart failure related adverse event.|6 month to the 12 month visit|||participants|||Number
718364|NCT00279955|Primary|Occurrence of Heart Failure (HF) Related Adverse Event (AE)|Number of participates with HF realted adverse event will be reported. Time to the first HF related Adverse event in the “Follow-up Period” from the 6-month visit to the 12-month visit is compared between two risk groups. The goal was to test if there is a significant difference in time to first HF-related adverse event between two groups. A heart failure related (HF-related) adverse event is defined as an adverse event that results in a subject’s worsening HF or related to the heart’s inability to meet the metabolic demands of the body.|From 6 month to the 12 month visit|Of the 1001 subjects meeting inclusion and exclusion criteria, 643 subjects had been followed longer than 6 months and had the OptiVolTM feature save-to-disk data available. Those 643 subjects were included in this analysis.||participants|||Number
718365|NCT00280059|Secondary|Medical Outcomes Study Sleep Scale (MOS-SS): Optimal Sleep Subscale|MOS-SS: subject-rated instrument used to assess the key constructs of sleep over the past week; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Optimal Sleep subscale is derived from sleep quantity average hours of sleep each night during the past week. Number of subjects with response Optimal if sleep quantity was 7 or 8 hours of sleep per night, and Non-optimal if average sleep was less than or greater than 7 to 8 hours per night. Analysis assesses the MOS-Sleep scale relative to the start of randomized treatment.|Week 8, Week 32, and Week 56|FAS||participants|||Number
718366|NCT00280059|Secondary|Change From Baseline to Week 56 in Hospital Anxiety and Depression Scale (HADS)|Participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items; range: 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of symptoms. Scores relative to start of randomized treatment.|Baseline to Week 56|FAS; N = number of participants with a HADS measurement at baseline and Week 56.||scores on scale||Standard Error|Least Squares Mean
718367|NCT00280059|Secondary|Percentage of Participants Who Achieved at Least 6 Consecutive Months of Seizure Freedom (Responders) by Final Dosage Levels and Treatment Group|Responder = participant who achieved at least 6-months of seizure freedom (all seizures) after Week 4, and up to Week 56. Dose Level defined as last total-daily-dose received after Week 4, and up to Week 56.|Week 5 up to Week 56|FAS; N = number of participants with analyzable data.||percentage of participants|||Number
718368|NCT00280059|Secondary|Mean Monthy Seizure Frequency of Responders for the Months After Achieving 6 Consecutive Months of Seizure Freedom: All Seizures|Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Responder = participant who achieved at least 6 months of seizure freedom after Week 4 and up to Week 56. Monthly seizure frequency measured from day of achievement of 6 months of seizure freedom.|Month 1 through Month 9 (after 6 months seizure freedom achieved)|FAS. N = number of responders; n = number of responders with analyzable data at observation.||28-day seizure rate||Standard Deviation|Mean
718369|NCT00280059|Secondary|Median Monthy Seizure Frequency of Responders for the Months After Achieving 6 Consecutive Months of Seizure Freedom: All Seizures|Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Responder = participant who achieved at least 6 months of seizure freedom after Week 4 and up to Week 56. Monthly seizure frequency measured from day of achievement of 6 months of seizure freedom.|Month 1 through Month 9 (after 6 months seizure freedom achieved)|FAS. N = number of responders; n = number of responders with analyzable data at observation.||seizures/28 days||Standard Deviation|Median
718370|NCT00280059|Secondary|Mean Monthy Seizure Frequency of Responders for the Months After Achieving 6 Consecutive Months of Seizure Freedom: All Partial Seizures|All partial seizures include complex partial seizures, simple partial seizures, and partial seizures evolving to secondarily generalized seizures. Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Responder = participant who achieved at least 6 months of seizure freedom after Week 4 and up to Week 56. Monthly seizure frequency measured from day of achievement of 6 months of seizure freedom.|Month 1 through Month 9 (after 6 months seizure freedom achieved)|FAS. N = number of responders; n = number of responders with analyzable data at observation.||28-day seizure rate||Standard Deviation|Mean
718371|NCT00280059|Secondary|Median Monthy Seizure Frequency of Responders for the Months After Achieving 6 Consecutive Months of Seizure Freedom: All Partial Seizures|All partial seizures include complex partial seizures, simple partial seizures, and partial seizures evolving to secondarily generalized seizures. Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Responder = participant who achieved at least 6 months of seizure freedom after Week 4 and up to Week 56. Monthly seizure frequency measured from day of achievement of 6 months of seizure freedom.|Month 1 through Month 9 (after 6 months seizure freedom achieved)|FAS. N = number of responders; n = number of responders with analyzable data at observation.||seizures/28 days||Standard Deviation|Median
718373|NCT00280059|Secondary|Median Monthy Seizure Frequency: All Seizures|Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Month of time = number of months after Week 4 (Dose Escalation).|Baseline up to Week 60|FAS. N = number of participants with analyzable data; n = number of participants with analyzable data at observation.||seizures/28 days||Standard Deviation|Median
718374|NCT00280059|Secondary|Mean Monthy Seizure Frequency: All Partial Seizures|All partial seizures include complex partial seizures, simple partial seizures, and partial seizures evolving to secondarily generalized seizures. Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Month of time = number of months after Week 4 (Dose Escalation).|Baseline up to Week 60|FAS. N = number of participants with analyzable data; n = number of participants with analyzable data at observation.||seizures/28 days||Standard Deviation|Mean
718375|NCT00280059|Secondary|Median Monthy Seizure Frequency: All Partial Seizures|All partial seizures include complex partial seizures, simple partial seizures, and partial seizures evolving to secondarily generalized seizures. Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Month of time = number of months after Week 4 (Dose Escalation).|Baseline up to Week 60|FAS. N = number of participants with analyzable data; n = number of participants with analyzable data at observation.||seizures/28 days||Standard Deviation|Median
718376|NCT00280059|Secondary|Time to First Seizure After the 4-Week Dose Escalation Phase|Time in days, from first day of study treatment to the day of first seizure after Day 28 of the escalation phase (ie, last day on study medication). Participants who did not reach this phase or who did not have a seizure after Day 28 were right censored from the analysis as of the last day on study medication.|Week 4 up to Week 56|FAS. N = number of participants who entered maintenance phase of study and had seizure efficacy data.||days||95% Confidence Interval|Median
718377|NCT00280059|Secondary|Exit Due to Any Reason After 4-week Dose Escalation Phase|Number of participants who exited the study due to any reason after the 4-week dose escalation phase. Time in days, from first day of study treatment to day of exit after Day 28 of the study due to any reason (ie, last day on study medication) was inestimable. Participants who did not exit or did not reach this phase were right censored as of the last day on study medication.|Week 4 up to Week 56|FAS. N = number of participants who entered maintenance phase of study and had seizure efficacy data. Time to exit for any reason after the 4-week dose escalation phase was inestimable as the survival estimate at the end of the maintenance phase was below 0.500.||participants|||Number
718378|NCT00280059|Secondary|Exit Due to Lack of Efficacy After 4-week Dose Escalation Phase|Number of participants who exited the study due to lack of efficacy after the 4-week dose escalation phase. Time in days, from first day of study treatment to day of exit due to lack of efficacy after Day 28 of the escalation phase (ie, last day on study medication) was inestimable. Participants who did not exit or exited for a different reason were right censored as of the last day on study medication.|Week 4 up to Week 56|FAS. N = number of participants who entered maintenance phase of study and had seizure efficacy data. Time to exit due to lack of efficacy after 4-week dose escalation phase was inestimable as survival estimate at end of maintenance phase was below 0.500.||participants|||Number
718379|NCT00280059|Secondary|Exit for Any Reason During the Double-blind Treatment Phase (Including Dose Escalation Phase)|Number of participants who exited the study for any reason during the double blind treatment phase. Time in days, from first day of study treatment to day of exit from the study due to any reason (ie, last day on study medication) was inestimable. Participants who did not exit the study were right censored as of the last day on study medication.|Week 0 to Week 56|FAS. N = number of participants who had at least 1 dose of study treatment and seizure efficacy data Time to exit for any reason during the double-blind treatment phase was inestimable as the survival estimate at the end of the maintenance phase was below 0.500.||participants|||Number
718380|NCT00280059|Secondary|Exit Due to Adverse Events During the Double-blind Treatment Phase (Including Dose Escalation Phase)|Number of participants who exited the study due to adverse events during the double-blind treatment period. Time in days, from first day of study treatment to day of exit from the study due to an adverse event (ie, last day on study medication) during the double blind treatment period (including dose escalation phase) was inestimable. Observations with other reasons for exiting or participants who did not exit the study were right censored as of the last day on study medication.|Week 0 to Week 56|FAS. N = number of participants who entered maintenance phase of study and had seizure efficacy data. Time to exit due to adverse events was inestimable as survival estimate at end of maintenance phase was below 0.500.||participants|||Number
718381|NCT00280059|Secondary|Time to 6 Consecutive Months of Seizure-freedom After 4-week Dose Escalation Phase: All Seizures|Time in days, from first day of study medication to the first 6 months of seizure freedom after Day 28. Participants who did not achieve 6 months seizure freedom after Day 28 were censored from analysis.|Week 4 up to Week 56|FAS. N = number of participants who entered maintenance phase of study and had seizure efficacy data.||days||95% Confidence Interval|Median
718382|NCT00280059|Primary|Percentage of Seizure-free Participants (Responders) During Efficacy Assessment Phase|Responders = participants who achieved any 6 consecutive months (>182 days) of seizure-freedom (absence of partial seizures, generalized seizures and unclassified epileptic seizures) during the 52 week efficacy assessment phase.|Week 5 up to Week 56|Full analysis set (FAS) (intent to treat population): randomized participants who took at least 1 dose of study medication. N = number of participants who had at least 1 dose of study treatment and seizure efficacy data. Analysis excludes participants who did not enter maintenance phase of study.||percentage of participants|||Number
718383|NCT00280150|Secondary|Feasibility and Tolerability of Administering Consolidation Therapy|The proportion of patients who were able to complete consolidation therapy after induction therapy and chemoradiotherapy|6 cycles|Of the initial 14 patients, only 9 (64%) patients were able to start consolidation therapy and only 5 (36%) patients were able to complete 6 cycles.||Participants|||Count of Participants
718443|NCT00281099|Secondary|ICD-indicated Patients With Class I Pacemaker Indication.|Number of subjects screened prior to enrollment that had Class I pacing indication at time of implant|Period of time prior to patient consent when considering patient for Implant/Enrollment|Centers kept a screening log, recording for each patient considered for new ICD implant and possible trial enrollment whether the patient had a Class I pacing indication at time of implant. The analysis consisted of descriptive statistics (counts of the 2051 screened patients).||participants|||Number
718384|NCT00280150|Secondary|Overall Response Rate and Survival Profile|The overall response rate (ORR) to the two cycles of induction therapy plus bevacizumab in stage IIIA/B NSCLC. ORR is the portion of patients with a tumor size reduction for a minimum time period. Response duration is measured from the time of initial response until documented tumor progression.|5 years|Of the 46 patients, one was retrospectively diagnosed as having stage IV NSCLC after induction therapy was withdrawn from the protocol therapy leaving 45 evaluable patients.||percentage of participants||95% Confidence Interval|Number
718385|NCT00280150|Secondary|Response Rate to Induction Therapy (Phase I [Closed to Accrual as of 1/3/2008] and II)|"Measurable lesions must be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm with conventional techniques or as > 10mm with spiral CT scan or nonmeasurable, but evaluable. Evaluable is nonmeasurable disease that includes ascites, malignant pleural/pericardial effusion, bone lesions, or marrow involvement. The same method of assessment and the same techniques should be used to characterize each identified and reported lesion at baseline and during follow-up.
Complete Response (CR)- Disappearance of all target lesions"|5 years|43 of 45 patients received both cycles of induction C/P therapy plus bevacizumab.||Participants|||Count of Participants
718386|NCT00280150|Secondary|Progression-free Survival (PFS)|The length of time during and after the treatment of a stage IIIA/B NSCLC that a patient lives with the disease but it does not get worse. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|5 years|Of the 46 patients, one was retrospectively diagnosed as having stage IV NSCLC after induction therapy was withdrawn from the protocol therapy leaving 45 evaluable patients.||Months||95% Confidence Interval|Median
718387|NCT00280150|Primary|Safety and Toxicity Profile of Combining Both Bevacizumab and Erlotinib Hydrochloride With Carboplatin, Paclitaxel, and Thoracic Conformal Radiotherapy|A list of Hematologic and nonhematologic toxicities associated with induction and concurrent therapy. This includes the percentage of patients who experienced grades 2-4 based on the National Cancer Institute Common Terminology Criteria for Adverse Events (version 3.0).|6 weeks after completion of therapy|Of the 46 patients, one was retrospectively diagnosed as having stage IV NSCLC after induction therapy was withdrawn from the protocol therapy leaving 45 evaluable for toxicity. 42 patients were eligible for concurrent therapy.||percentage of participants|||Number
718388|NCT00280150|Primary|Maximum Dose of Erlotinib When Given Together With Carboplatin, Paclitaxel, and Thoracic Conformal Radiotherapy (Phase I [Closed to Accrual as of 1/3/2008])|Dose-limiting toxicities (DLTs) were used to establish which cohort would be used for the phase II portion of the trial. DLTs were defined as any grade 3 or 4 nonhematologic toxicity with the exception of esophagitis, which had to be grade 4; grade 4 neutropenia lasting greater than or equal to 7 days and thrombocytopenia to less than 20,000/microliter.|6 weeks after completion of therapy|This was a phase I objective only, so the phase II participants are not included.||DLTs|||Number
718389|NCT00280241|Secondary|Duration of Response|The length of time for which the complete response is maintained.|From complete response to the time of progressive disease, death or last clinical examination|||Months||Full Range|Median
718390|NCT00280241|Primary|Efficacy of Rituximab, Cyclophosphamide and Fludarabine in Patients With Previously Untreated CLL/SLL|The number of patients who experience a complete clinical response.|Three months after the sixth cycle (9 months)|||participants|||Number
718391|NCT00280241|Secondary|Overall Survival Rate|The percentage of participants who are still alive.|Five years after starting rituximab, cyclophosphamide and fludarabine|||percentage of participants||95% Confidence Interval|Number
718392|NCT00280241|Primary|Tolerability of Rituximab, Cyclophosphamide and Fludarabine in Patients With Previously Untreated CLL/SLL|The number of patients who experience any grade 3-5 toxicity.|Duration of treatment on study|||participants|||Number
718393|NCT00280293|Primary|Positive Urine Drug Screens|Percentage of participants with a positive urine drug screen for cocaine at the week 10 visit or at last assessment if participant withdrew early.|10 weeks|||percentage of participants|||Number
718394|NCT00280293|Secondary|Dollars Spent|Dollars spent on cocaine during the 7 days of week 10, or at last assessment if participant withdrew early, based on self report.|10 weeks|||Dollars||Standard Deviation|Mean
718395|NCT00280293|Secondary|Depression Score on the Hamilton Rating Scale For Depression|Total score on the Hamilton Rating Scale for Depression at week 10 visit or at last assessment if participant withdrew early(total score values range 0 - 52. A higher score indicates more severe depression.|10 weeks|||units on a scale||Standard Deviation|Mean
718396|NCT00280293|Primary|Days of Cocaine Use|Number of days of cocaine use during the 7 days that comprise week 10 of the protocol, by self report, or at last assessment if participant withdrew early, as assessed by the Timeline Followback method.|10 weeks|||days||Standard Deviation|Mean
718397|NCT00280384|Primary|Extensor Digitorum Brevis (EDB) Muscle M-Wave Area At Baseline|The pharmacodynamic effect of botulinum toxin type B (E2014) was evaluated based on the inhibition of EDB M-wave area induced by stimulation of the deep peroneal nerve in the left ankles of the study participants. EDB M-wave area (mVms) was measured at screening (baseline).|Baseline|||EDB M-Wave Area at Baseline (mVms)||Standard Deviation|Mean
718398|NCT00280384|Primary|Maximum Rates of Extensor Digitorum Brevis (EDB) Muscle M-Wave Area Reduction From Baseline|The pharmacodynamic effect of botulinum toxin type B (E2014) was evaluated based on the inhibition of EDB M-wave area induced by stimulation of the deep peroneal nerve in the left ankles of the study participants. EDB M-wave area (mVms) was measured at screening (baseline), and Day 1, Day 2, Day 4, Day 6, Day 8, Day 10, Day 14, Week 4, and Week 12. Rates of EDB M-wave area reduction from baseline were then calculated at each time point. The maximum rates of EDB M-wave area reduction from baseline were presented as a percentage.|Baseline and Up to 12 Weeks|||Percentage of Reduction||Standard Deviation|Mean
718399|NCT00280384|Primary|Extensor Digitorum Brevis (EDB) Muscle M-Wave Amplitude at Baseline|The pharmacodynamic effect of botulinum toxin type B (E2014) was evaluated based on the inhibition of EDB M-wave amplitude induced by stimulation of the deep peroneal nerve in the left ankles of the study participants. EDB M-wave amplitudes (mV) were measured at screening (baseline).|Baseline|||EDB M-Wave Amplitude at Baseline (mV)||Standard Deviation|Mean
719207|NCT00294684|Secondary|Serum Total Bilirubin Concentration||Measurements will be made at 3 months after portoenterostomy|Intent to treat patients with 3 month bilirubin available are analyzed. There are no imputations for unobserved data. Patients with missing data are simply not included.||mg/dL||Standard Deviation|Mean
718400|NCT00280384|Primary|Maximum Rates of Extensor Digitorum Brevis (EDB) Muscle M-Wave Amplitude Reduction From Baseline|The pharmacodynamic effect of botulinum toxin type B (E2014) was evaluated based on the inhibition of EDB M-wave amplitude induced by stimulation of the deep peroneal nerve in the left ankles of the study participants. EDB M-wave amplitudes (mV) were measured at screening (baseline), and Day 1, Day 2, Day 4, Day 6, Day 8, Day 10, Day 14, Week 4, and Week 12. Rates of EDB M-wave amplitude reduction from baseline were then calculated at each time point. The maximum rates of EDB M-wave amplitude reduction from baseline were presented as a percentage.|Baseline and Up to Week 12|||Percentage of Reduction||Standard Deviation|Mean
718401|NCT00280397|Secondary|To Make Exploratory Analyses of Pharmacodynamic Markers||Every 3 weeks||||||
718402|NCT00280397|Secondary|Evaluate the Anti-tumor Activity of E7080||Every 3 weeks||||||
718403|NCT00280397|Secondary|Determine the Clinical Dose for Phase II Study Based on Safety and Pharmacokinetic Profile||Every 3 weeks||||||
718404|NCT00280397|Primary|DLT of E7080 Repeatedly Administered Twice a Day|DLTs were defined as grade 3 or more platelet count decrease, grade 4 neutropenia, any grade 3 or more nonhematologic toxicity (with exceptions of grade 4 hypertension not controlled by any antihypertensive drugs and grade greater than or equal to 3 vomiting and diarrhea not controlled by antiemetic or antidiarrheal drugs), and failure to administer more than 75% of the planned doses of E7080 during the same cycle due to toxicity.|up to 4 weeks|Registered participants were included in the tolerability analysis set with the exception of the ineligible participants, participants with a treatment compliance rate of less than 75%, and participants who discontinued the study for reasons other than occurrence of DLT. However, cases of DLT shall be included in analyses.||Participants with DLT|||Number
718405|NCT00280397|Secondary|Number of Participants With Adverse Events / Serious Adverse Events|Treatment emergent adverse events (AEs) and serious adverse events (SAEs) were evaluated.|Until tumor progression, unacceptable toxicity, or withdrawal due to other reasons.|All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.||Participants|||Number
718406|NCT00280397|Primary|Maximum Tolerable Dose (MTD) of E7080 Repeatedly Administered Twice a Day|The MTD was defined as the highest dose at which no dose limiting toxicity (DLT) was experienced by the first 3 patients in that cohort, or the dose at which a DLT was experienced by no more than 1 of 6 patients evaluable for toxicity.|up to 4 weeks|Registered participants were included in the tolerability analysis set with the exception of the ineligible participants, participants with a treatment compliance rate of less than 75%, and participants who discontinued the study for reasons other than occurrence of DLT. However, cases of DLT shall be included in analyses.||mg BID|||Number
718407|NCT00280397|Secondary|To Elucidate the Pharmacokinetic Profile of E7080||Every 3 weeks||||||
718408|NCT00280566|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Negative Scale by Visit During Double Blind Period|Baseline for Period 2 is the last observation in Period 1 to the start of Period 2. Negative Scale is 7 items derived from PANSS; scale is 1 (absent) to 7 (extreme).|Period 2: Weeks 4 - 24 or time of early termination|intent to treat (ITT); (n) = number of subjects with analyzable data at observation for ziprasidone and placebo, respectively.||scores on scale||Standard Deviation|Mean
718409|NCT00280566|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Postive Scale by Visit During Double Blind Period|Baseline for Period 2 is the last observation in Period 1 to the start of Period 2. Positive Scale is 7-items derived from PANSS; 1 (absent), 2 (minimal) to 7 (extreme).|Period 2: Weeks 4 - 24 or time of early termination|intent to treat (ITT); (n) = number of subjects with analyzable data at observation for ziprasidone and placebo, respectively.||scores on scale||Standard Deviation|Mean
718410|NCT00280566|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Visit During Double Blind Period|Baseline for Period 2 is the last observation in Period 1 to the start of Period 2. Positive and Negative Syndrome Scale Total Score is 30-item scale measuring severity of psychopathology (16 items), positive symptoms (7 items) and negative symptoms (7 items); scale from 1 (absent) to 7 (extreme)|Period 2: Weeks 4 - 24 or time of early termination|intent to treat (ITT); (n) = number of subjects with analyzable data at observation for ziprasidone and placebo, respectively.||scores on scale||Standard Deviation|Mean
718411|NCT00280566|Secondary|Change From Baseline in Montgomery-Asberg Rating Scale (MADRS) Score by Visit During Double Blind Period|Baseline for Period 2 is the last observation in Period 1 to the start of Period 2. MADRS is 10-item instrument measuring depression: scales from 0=Normal to 6 = most abnormal.|Period 2: Weeks 1 - 24 or time of early termination|Intent to Treat (ITT); (n) = number of subjects with analyzable data at observation for ziprasidone and placebo, respectively.||scores on scale||Standard Deviation|Mean
718412|NCT00280566|Secondary|Clinical Global Impression - Improvement (CGI-I) Score by Visit During Double Blind Period|Clinical Global Impression measures 7 items in Global assessment of improvement in patient's condition; 0=not assessed, 1= very much improved to 7= very much worse.|Period 2: Weeks 1 - 24 or time of early termination|Intent to treat (ITT); (n) = number of subjects with analyzable data at observation for ziprasidone and placebo, respectively.||scores on scale||Standard Deviation|Mean
718413|NCT00280566|Secondary|Change From Baseline in Clinical Global Impression Severity (CGI-S) Score by Visit During Double Blind Period|Baseline for Period 2 is the last observation in Period 1 to the start of Period 2. Clinical Global Impression Severity Score is 7-item scale rates severity of illness from 0=not assessed, 1= normal to 7=most extremely ill.|Period 2: Weeks 1 - 24 or time of early termination|intent to treat (ITT); (n) = number of subjects with analyzable data at observation for ziprasidone and placebo, respectively.||scores on scale||Standard Deviation|Mean
718414|NCT00280566|Secondary|Change From Baseline in Mania Rating Scale (MRS) by Visit During Double Blind Period|Period 2 Baseline = last observation in Period 1 to the start of Period 2. MRS is 11-item scale to measure mania; derived from Schedule for Affective Disorders and Schizophrenia-Change Behavior (SADS-CB). Subscales: Manic Syndrome (elevated mood, less need for sleep, excessive energy and activity, grandiosity), Behavior and Ideation (irritability, motor hyperactivity, accelerated speech, racing thoughts, poor judgment), and Impaired Insight. Racing thoughts range=0 to 2 (highest level of abnormal=2); all other items 0 to 5 (highest level of abnormal=5). Higher score = greater abnormality.|Period 2: Weeks 1 - 24 or time of early termination|Intent to Treat (ITT); (n) = number of subjects with analyzable data at observation for ziprasidone and placebo, respectively.||scores on scale||Standard Deviation|Mean
718415|NCT00280566|Secondary|Modified Time to Intervention for a Mood Episode (TIME)|Time to intervention for a mood episode or time to discontinuation for treatment related adverse events, or death due to drug, or death due to disease. Mood episode considered to have occurred and subject discontinued if one or more of the following: Investigator (INV) decides discontinuation is in best interest of subject; loss of effect and/or change to treatment regimen (INV judgment); subject hospitalized for disease under study; Mania Rating Scale (MRS) and/or Montgomery-Asberg Rating Scale (MADRS) rating is ≥18 for 2 consecutive visits scheduled no more than 10 days apart.|Period 2: Week 24 or time of early termination|Intent to Treat (ITT). 29 out of 127 ziprasidone subjects and 38 out of 111 placebo subjects met the modified criteria for an intervention for a mood episode||Days||Standard Error|Mean
718416|NCT00280566|Secondary|Time to Discontinuation for Any Reason During Double Blind Period 2|Key Secondary endpoint is time to discontinuation for any reason. Profile of patients remaining in the trial over time.|Period 2: 24 weeks or time of early termination|Intent to Treat (ITT). Number of participants who discontinued was 43 and 57 for ziprasidone and placebo, respectively.||days||Standard Error|Mean
718417|NCT00280566|Primary|Time to Intervention for a Mood Episode During Double Blind Period|Time to Intervention for Mood Episode (TIME) while on randomized drug after at least 8 weeks of symptom reduction on open-label ziprasidone plus mood stabilizer. Mood episode considered to have occurred and subject discontinued if one or more of the following: Investigator (INV) decides discontinuation is in best interest of subject; loss of effect and/or change to treatment regimen (INV judgment); subject hospitalized for disease under study; Mania Rating Scale (MRS) and/or Montgomery-Asberg Rating Scale (MADRS) rating is ≥18 for 2 consecutive visits scheduled no more than 10 days apart.|Period 2: 24 weeks or time of early termination|Intent to Treat (ITT):Subjects took at least 1 dose double blind medication and had at least 1 post randomization observation. Double Blind Period followed at least 8 weeks open-label ziprasidone plus mood stabilizer; 25 out of 127 and 36 out of 111 subjects had an intervention for a mood episode.||Days||Standard Error|Mean
718418|NCT00280683|Secondary|L-arginine Serum Concentration||90 days|||pmol/100ul||Standard Error|Mean
718419|NCT00280683|Primary|Number of Asthma Exacerbations in Three Months|Asthma exacerbation is a composite endpoint. An asthma exacerbation is defined as any of the following: a) a drop in the morning peak expiratory flow rate (PEF) >30% from baseline on 2 consecutive days, b) a need for initiation of or increased dose of inhaled corticosteroids, or the c) doubling of short-acting rescue β-agonist drug use (e.g.Albuterol) on two consecutive days. Any one of these three counts as one asthma exacerbation.|3 months|Our original power analysis was based on an expected minor exacerbation rate of 3-4 per month.||exacerbations|||Number
718420|NCT00280735|Secondary|Overall Survival|Overall survival rate at 18 months.|The time between the start of treatment to disease progression or death or the date of last contact, measured up to 18 months|Participants receiving treatment||percentage of participants|||Number
718421|NCT00280735|Secondary|Progression Free Survival|Relapse-free survival rate at 18 months. Patients were determined to have progression either by radiographic and/or pathological assessment by local physician per local standard of care monitoring for disease recurrence.|The time between the start of treatment to disease progression or death or the date of last contact, measured up to 18 months|Participants receiving treatment||percentage of participants|||Number
718422|NCT00280735|Secondary|Toxicity in Patients Treated With This Regimen|Safety determinations are based on the rate of drug-related adverse events (AEs) reported based upon the toxicity as measured by the NCI Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0).|Day 1 of treatment to 30 days after treatment discontinuation|Patients receiving treatment||percentage of participants|||Number
718423|NCT00280735|Secondary|Patterns of Recurrence in Patients Treated With This Regimen|Patterns were assessed with a staging chest computerized tomography (CT), bone or positron emission tomography (PET) scan and brain magnetic resonance imaging (MRI)/CT scan at recurrence.|Up to 5 years|||Participants|||Count of Participants
718424|NCT00280735|Primary|Number of Participants Who Completed Four Cycles of the Carboplatin/Docetaxel Regimen|Feasibility was based on the percentage of patients completing four cycles of the carboplatin/docetaxel regimen to a high fraction of patients with curatively resected stage IIIIA non-small cell lung cancer within 12 weeks.|12 weeks from initiating adjuvant therapy|Patients assigned to treatment||Participants|||Count of Participants
718425|NCT00280748|Secondary|Response of Patients With Extracranial Disease Treated With Pemetrexed|Response was measured by Response Evaluation Criteria In Solid Tumors RECIST criteria v1.0. Complete Response (CR) - Disappearance of all lesions Partial Response (PR) - at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Stable Disease (SD) - neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started. Progressive Disease (PD) – at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing nontarget lesions.|maximum 5 months|This study was terminated due to slow enrollment and the planned statistical analyses could not be performed due to limit sample size. The data represents the results of patients enrolled and treated on the trial.||Participants|||Count of Participants
718426|NCT00280748|Secondary|Neurological Function by Mini Mental State Examination|The Mini Mental State Examination is a 30-point questionnaire that is used to measure cognitive impairment. Score totals range from normal cognition (24-30 points), mild impairment (19–23 points), moderate impairment (10–18 points), to severe impairment (≤9 points).|Baseline (pre-treatment), 30 days (Cycle 2 Day 1), and maximum 5 months (end of treatment).|This study was terminated due to slow enrollment and the planned statistical analyses could not be performed due to limited sample size. The data represents the results of patients enrolled and treated on the trial.||score on the scale||Full Range|Mean
718444|NCT00281099|Secondary|All Cause Mortality|Death from any cause|Enrollment to last visit (up to 45 months post-randomization) or death|"1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation (AF), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective."||participants who died|||Number
719208|NCT00294684|Secondary|Survival With Native Liver at 24 Months of Age||Measurements will be made at 24 months of age|Intent to Treat||percentage of participants|||Number
718427|NCT00280748|Secondary|Neurological Function by Radiation Oncology Group (RTOG) Neurological Function Classification|"A classification score defined as follows:
Able to work or to perform normal activities: neurological findings minor or absent
Able to carry out normal activities with minimal difficulties. Neurological impairment does not require nursing care or hospitalization
Seriously limited in performing normal activities. Requiring nursing care or hospitalization. Patients confined to bed or wheelchair or have significant intellectual impairment
Unable to perform even minimal normal activities. Requiring hospitalization and constant nursing care and feeding. Patients unable to communicate or in coma.A higher score indicates worse function."|At Baseline, 30 days, and at end of treatment (maximum 5 months).|This study was terminated due to slow enrollment and the planned statistical analyses could not be performed due to limit sample size. The data represents the results of patients enrolled and treated on the trial.||scores on a scale||Full Range|Mean
718428|NCT00280748|Secondary|Evaluate the Functional Status of Patients Treated With This Regimen.|"Functional status evaluated using the Karnofsky functional status scale. The Karnofsky Performance Scale (KPS) Index allows patients to be classified as to their functional impairment. This can be used to compare effectiveness of different therapies and to assess the prognosis in individual patients. The lower the Karnofsky score, the worse the survival for most serious illnesses. The Karnofsky score runs from 100 to 0, where 100 is perfect health and 0 is death."|baseline functional status only|||Participants|||Count of Participants
718429|NCT00280748|Secondary|Estimate the Overall Survival of Patients Treated With This Regimen.|Patients were followed for survival from start of treatment until death from any cause (up to 4 years)|4 years|Four patients were unevaluable due to extra-cranial disease progression or decline in performance status preventing re-evaluation.||months||Full Range|Median
718430|NCT00280748|Secondary|Number of Subjects Experiencing Adverse Events|"Toxicities was assessed using Common Terminology Criteria for Adverse Events (CTCAE) grading scale. Only toxicities with attribution to chemotherapy of definite or probable are considered, as determined by treating physician."|maximum 5 months|All patients who received treatment were evaluated||Participants|||Count of Participants
718431|NCT00280748|Primary|Response of Intracranial Metastases (Complete and Partial Response)|Radiographic response will be measured by RECIST, Response Evaluation Criteria In Solid Tumors Criteria, indicating if subject experienced a Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), no response or less response than Partial or Progressive; or Progressive Disease (PD), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|126 days|Of the 10 patients, four patients were unevaluable due to extra-cranial disease progression or decline in performance status prevent re-evaluation.||Participants|||Count of Participants
718432|NCT00280826|Secondary|Change in Visual Acuity in the Better Eye From Baseline to 16 Weeks|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. This acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters the Snellen measurement is 20/20.|Baseline and 16 weeks|||ETDRS letters||Standard Deviation|Mean
718433|NCT00280826|Secondary|Change in Visual Acuity in the Worse Eye From Baseline to 16 Weeks|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. This acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters the Snellen measurement is 20/20.|Baseline and 16 weeks|Analysis was per protocol||ETDRS letters||Standard Deviation|Mean
718434|NCT00280826|Secondary|Cystoid Macular Edema in the Better Eye as Assessed by Optical Coherence Tomography (OCT).|Better eye indicates the eye with better VA.|Baseline and 16 weeks|Analysis was per protocol||microns||Standard Deviation|Mean
718435|NCT00280826|Secondary|Cystoid Macular Edema in the Worse Eye as Assessed by Optical Coherence Tomography (OCT).|Worse eye indicates the eye with the worst visual acuity (VA).|Baseline and 16 weeks|Analysis was per protocol||microns||Standard Deviation|Mean
718436|NCT00280826|Primary|Number of Participants With Systemic Toxicities, Adverse Events, or Infections|Safety outcomes were recorded by observing and tabulating the nature, severity and frequency of systemic toxicities, adverse events and infections throughout the study. Safety assessments were made by the investigators continuously during the study, with a review of the previous visit interval performed at each scheduled visit. Each participant was also encouraged to report any apparent adverse events between scheduled visits and could return for additional evaluations or treatment between scheduled visits if needed.|16 weeks|Analysis was per protocol||Participants|||Number
718437|NCT00280904|Primary|Number of Subjects With Shunt Infections|Number of shunt infections occurring in subjects implanted with antibiotic impregnated catheters and standard catheters.|Implantation to Explant|||participants|||Number
718438|NCT00280904|Secondary|Non-infectious Antibiotic Impregnated (AI) and Standard Catheter Subjects With Shunt Failures||April 2008|||participants|||Number
718439|NCT00280917|Secondary|Safety|Vital signs and weight, physical examinations, adverse event (AE) reporting, clinical laboratory testing, including liver function, renal function, complete blood count and clinical chemistries, urinalysis, and hematologic testing and 12-lead resting ECGs|12 weeks||||||
718440|NCT00280917|Secondary|ACR Criteria Components|ACR 20 response at all visits in the evaluable population and ACR 50 and ACR 70 responses at all visits in the ITT and evaluable populations using both nonresponder imputation and Last Observation Carried Forward (LOCF) analyses; change and percent change from baseline at each visit in the ITT and evaluable populations, analyzed using LOCF, in ACR response components [tender joint count, swollen joint count, patient assessment of pain by VAS, patient global assessment of disease activity by VAS, physician global assessment of disease activity by VAS, HAQ DI, CRP (by central laboratory, using an standard-sensitivity assay capable of detecting changes below the upper limit of normal) and ESR], Disease Activity Score (DAS28), and duration of morning stiffness.|12 weeks||||||
718441|NCT00280917|Primary|ACR Efficacy Criteria|ACR 20 response (20% improvnent in RA based on swollen and tender joint counts, physician and patient global assessments of disease activity, a patient pain score) at endpoint (Week 12), with all-cause dropouts considered as nonresponders (nonresponder imputation) in the Intent-To-Treat (ITT) population|12 weeks|||participants|||Number
718442|NCT00281021|Primary|Therapeutic Response, Evaluated by Computed Tomography (CT) Scans of Chest & Abdomen.||Measured every 6 weeks after baseline until disease progression, an average of 3 months|||participants|||Number
718445|NCT00281099|Secondary|"Quality of Life (QOL) Score"|"Minnesota Living with Heart Failure Questionnaire (MLWHFQ) and Kansas City Cardiomyopathy Questionnaire (KCCQ) Quality of Life(QOL) Scores. For KCCQ, positive values mean improved QOL compared to baseline. For MLWHFQ, negative values mean improved QOL compared to baseline.
Scales: KCCQ 0-100 (0=worst, 100 best); MLWHFQ 0-105 (105=worst, 0=best)"|Baseline, 12, 24, and 36 month visits|"1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation (AF), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective."||Units on a scale||Standard Deviation|Mean
718446|NCT00281099|Secondary|Percent Ventricular Pacing|The percentage of a patients' ventricular beats that were paced by the device.|Enrollment, 6, 12, 24 and 36 month visits|"1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation (AF), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective."||Percent pacing||Standard Deviation|Mean
718447|NCT00281099|Secondary|"Medication Usage Affecting Heart Rate and Atrioventricular (AV) Conduction"|Whether a subject is on each of a pre-specified set of drugs or classes of drugs.|Enrollment, 6 Months, 12 Months, 24 Months, 30 Months, 36 Months|"1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation (AF), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective."||Percentage of Subjects|||Number
718448|NCT00281099|Secondary|Development of a Pacing Indication During the Study|Physician identification of a Class I Pacing Indication. A Class I Pacing Indication implies that the benefit of pacing the heart far exceeds the risk, and that the procedure to implant the pacing device should be performed. For this indication there is general agreement that pacing the heart is beneficial, useful, and effective.|Enrollment to last visit (up to 45 months post-randomization)|"1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation (AF), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective."||participants|||Number
718449|NCT00281099|Secondary|Occurrence of Clinically Important or Persistent Atrial Tachycardia or Atrial Fibrillation (AT/AF) in Subjects With no Prior AF History|"Persistent AF was defined as any of the following:
2 consecutive visits in which the patient presents with AF
7 consecutive days of at least 22 hours per day of AT/AF
A cardioversion prior to 7 consecutive days of at least 22 hours per day of AT/AF
Clinically Important AF was defined as more than 20 hours of AT/AF in a single day"|Enrollment to last collection of data from the implanted ICD (up to 45 months post-randomization)|1 of 1031 randomized subjects had a history of at least 6 months of chronic AF, which was an exclusion criterion. Of the remaining 1030 randomized subjects that met all inclusion criteria, only those with no history of AF were included in the analysis (445 in the VVI 40 arm and 444 in the MVP arm). An intention to treat analysis was performed.||participants|||Number
718450|NCT00281099|Secondary|"Occurrence of Ventricular Tachycardia (VT) and Ventricular Fibrillation (VF) Episodes"|Annualized Rates of Days of True VT/VF and Inappropriately detected non-VT/VF|Enrollment to last collection of data from the implanted ICD (up to 45 months post-randomization)|"1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation (AF), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective."||Annualized Episodes per Patient Month|||Number
718451|NCT00281099|Secondary|Composite Mitral Regurgitation (MR) Severity Score|"Echocardiogram measures for this endpoint were obtained at multiple time points. Composite MR Severity was measured on a scale of None to Trivial to Grade IV, with Grade IV being the worst possible score and None to Trivial being the best possible score."|Baseline, 12, and 24 month visits|||participants|||Number
718452|NCT00281099|Secondary|Left Atrial (LA) and Mitral Regurgitation (MR) Areas|Echocardiogram measures for each endpoint were obtained at multiple time points.|Baseline, 12, and 24 month visits|"1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation (AF), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective."||centimeters squared (cm2)||Standard Deviation|Mean
718453|NCT00281099|Secondary|Hemodynamic Deceleration Time|Echocardiogram measures for each endpoint were obtained at multiple time points.|Baseline, 12, and 24 month visits|"1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation (AF), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective."||milliseconds (ms)||Standard Deviation|Mean
718454|NCT00281099|Secondary|Hemodynamic Velocity Measures|Echocardiogram measures for each endpoint were obtained at multiple time points.|Baseline, 12, and 24 month visits|"1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation (AF), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective."||meters per second (m/s)||Standard Deviation|Mean
718455|NCT00281099|Secondary|Left Ventricular (LV) Sphericity Index|"Echocardiogram measures for each endpoint were obtained at multiple time points.
LV Sphericity Index is a ratio of LV long axis dimension to the LV short axis dimension. Healthy hearts have an elliptical LV cross-sectional shape. A value of 1 denotes a circular or more globular shape, while larger values denote healthier hearts with more elliptical cross sections. Literature has shown that when the ratio used is short axis/long axis, normal hearts have a median LV sphericity index of 0.56, with a range of (0.51-0.60). This translates to median=1.79,range=(1.67,1.96) for long/short axis."|Baseline, 12, and 24 month visits|"1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation (AF), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective."||Ratio||Standard Deviation|Mean
718470|NCT00281463|Primary|Oxygen Consumption||in-lab visit when propelling on a computer controlled wheelchair dynamometer|PAPAW (.9 m/s, 10 W)||VO2 (ml/min)||Standard Deviation|Mean
718471|NCT00281463|Primary|Oxygen Consumption||in-lab visit when propelling on a computer controlled wheelchair dynamometer|personal w/c (.9 m/s, 10 W)||VO2 (ml/min)||Standard Deviation|Mean
718456|NCT00281099|Secondary|Left Ventricular (LV) and Left Atrial (LA) Volumes|Echocardiogram measures for each endpoint were obtained at multiple time points.|Baseline, 12, and 24 month visits|"1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation (AF), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective."||milliliters (mL)||Standard Deviation|Mean
718457|NCT00281099|Secondary|Left Ventricular (LV) Ejection Fraction and Fractional Shortening|"Echocardiogram measures for each endpoint were obtained at multiple time points.
LV Ejection Fraction is the percentage of a patient's blood moved out of the left venricle when the heart pumps. The measure is recorded as a percentage(0-100%) and the normal range is 50-85%.
LV Fractional Shortening is the percent change in a patient's LV internal dimensions between systole (when the ventricles contract and expel blood) and diastole (when the ventricles expand and receive blood). The measure is recorded as a percentage(0-100%) and the normal range is 30-45%."|Baseline, 12, and 24 month visits|"1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation (AF), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective."||percentage of LV unit||Standard Deviation|Mean
718458|NCT00281099|Secondary|Heart Chamber Dimensions and Wall Thicknesses|Echocardiogram measures for each endpoint were obtained at multiple time points.|Baseline, 12, and 24 month visits|"1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation (AF), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective."||centimeters (cm)||Standard Deviation|Mean
718459|NCT00281099|Secondary|Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time|NYHA Classification at each scheduled Follow-up visit. The scale for this measure is as follows: NYHA I= best, NYHA IV= worst.|Baseline, 12, 24 and 36 month visits|"1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation (AF), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective."||participants|||Number
718460|NCT00281099|Secondary|Occurrence of Worsening Heart Failure-related Adverse Events|HF event meeting primary endpoint definition, or adverse events associated with, but not limited to, any of the following: symptoms or physical signs compatible with worsening HF, laboratory evidence of HF, any modification of oral heart failure therapy|Enrollment to last visit (up to 45 months post-randomization)|"1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation (AF), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective."||participants/events|||Number
718461|NCT00281099|Primary|"All Cause Mortality and Heart Failure-related Urgent Care Visits and Heart Failure (HF) Hospitalizations."|A composite endpoint of all cause mortality and HF hospitalizations or urgent care. (Emergency Department, Urgent Clinic visits, or hospitalizations wiht intravenous medications for HF)|Enrollment to last visit (up to 45 months post-randomization) or death|"1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation (AF), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective."||events|||Number
718462|NCT00281320|Primary|Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Dn-AUC 0-12|dn-AUC 0-12 defined as dose-normalized area-under-the-curve from zero to time point 12 hours.|Day 4 or 8|All-Subjects-Pharmacokinetically-Evaluable Group defined as all subjects for which at least one pharmacokinetic parameter could be calculated and who did not have any protocol violations interfering with pharmacokinetics.||ng*h/mL/mg||Standard Deviation|Mean
718463|NCT00281320|Primary|Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, AUC 0-12|AUC 0-12 defined as area-under-the-curve from zero to time point 12 hours.|Day 4 or 8|All-Subjects-Pharmacokinetically-Evaluable Group defined as all subjects for which at least one pharmacokinetic parameter could be calculated and who did not have any protocol violations interfering with pharmacokinetics.||ng*h/mL||Standard Deviation|Mean
718464|NCT00281320|Primary|Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Cmin|Cmin defined as pre-dose concentration.|Day 4 or 8|All-Subjects-Pharmacokinetically-Evaluable Group defined as all subjects for which at least one pharmacokinetic parameter could be calculated and who did not have any protocol violations interfering with pharmacokinetics.||ng/mL||Standard Deviation|Mean
718465|NCT00281320|Primary|Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis , Dn-Cmax|dn-Cmax is defined as dose normalized peak concentration.|Day 4 or 8|All-Subjects-Pharmacokinetically-Evaluable Group defined as all subjects for which at least one pharmacokinetic parameter could be calculated and who did not have any protocol violations interfering with pharmacokinetics.||ng/mL/mg||Standard Deviation|Mean
718466|NCT00281320|Primary|Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis,Cmax|Cmax defined as peak concentration.|Day 4 or 8|All-Subjects-Pharmacokinetically-Evaluable Group defined as all subjects for which at least one pharmacokinetic parameter could be calculated and who did not have any protocol violations interfering with pharmacokinetics.||ng/mL||Standard Deviation|Mean
718467|NCT00281320|Primary|Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Tmax|Tmax defined as time to peak concentration.|Day 4 or 8|All-Subjects-Pharmacokinetically-Evaluable Group defined as all subjects for which at least one pharmacokinetic parameter could be calculated and who did not have any protocol violations interfering with pharmacokinetics.||hours||Full Range|Median
718468|NCT00281320|Primary|Number of Participants Who Discontinued Because of an Adverse Event|Discontinuations due to treatment-emergent adverse events starting on or after Day1 and up to 7 days after study medication stop date (30 days for serious adverse events).|up to 30 days after study medication stop date|Per protocol||participants|||Number
718469|NCT00281320|Primary|Number of Participants Who Experienced an Adverse Event|Participants who experienced treatment-emergent adverse events, defined as newly reported events after baseline or events reported to have worsened in severity since baseline (from the date of informed consent to the last dose day + 7 days for non-serious adverse events and 30 days for serious adverse events).|Up to Day 42 (treatment period)|Per protocol||Participants|||Number
718472|NCT00281528|Secondary|Kaplan Meier Estimate for Progression-Free Survival (PFS)|PFS was defined as the time from the first dose of study drug to the start of progression or patient death (any cause) whichever occurred first. Participants that did not have progression or have not died were censored at the last known time the participant was progression free. Participants that initiate other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated.|up to 56 months|Treated population||months||95% Confidence Interval|Median
718473|NCT00281528|Primary|The Number of Participants With a Dose Interruption of ABI-007|Number of participants who interrupted (omitted) a dose at some point in the treatment period. This outcome is considered to be both a safety and an efficacy outcome.|Up to 53 months|Treated population||Participants|||Number
718474|NCT00281528|Primary|The Number of Participants With at Least One Dose Delay for ABI-007|Participants with at least one dose delay for ABI-007. Treatment delays of no longer than 2 weeks allowed participants to recovery from acute toxicity. If treatment was delayed beyond 2 weeks, continuing treatment on protocol was at the physician’s discretion, based upon the best interests of the participant. This outcome is considered to be both a safety and an efficacy outcome.|Up to 53 months|Treated population||Participants|||Number
718475|NCT00281528|Primary|The Number of Participants With at Least One Dose Reduction for ABI-007|Participants with at least one dose reduction for ABI-007. ABI-007 (Abraxane) dose could be reduced according to protocol guidelines if the participant was experiencing toxicities. Participants were allowed two ABI-007 (Abraxane) dose reductions during the course of the trial. This outcome is considered to be both a safety and an efficacy outcome.|Up to 53 months|Treated population||Participants|||Number
718476|NCT00281528|Primary|Participant Counts of the Most Severe Grade for Hemoglobin Levels as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Experience (NCI CTCAE v3)|"Myelosuppression is a decrease in the ability of the bone marrow to produce blood cells. The lowest measured (nadir) hemoglobin levels were graded using NCI CTCAE version 3:
Grade 0 = within normal limits; Grade 1 = < lower limit of normal - 100g/L; Grade 2 = <100 - 80g/L; Grade 3 = <80 - 65g/L; Grade 4 = <65g/L"|up to 54 months|Treated population who had at least one post baseline value||participants|||Number
718477|NCT00281528|Primary|Participant Counts of the Most Severe Grade for Platelet Counts as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Experience (NCI CTCAE v3)|"Myelosuppression is a decrease in the ability of the bone marrow to produce blood cells. The lowest measured (nadir) platelet counts were graded using NCI CTCAE version 3:
Grade 0 = within normal limits; Grade 1 = < lower limit of normal - 75.0*10^9/L; Grade 2 = <75.0 - 50.0*10^9/L; Grade 3 = <50.0 - 25.0*10^9/L; Grade 4 = <25.0*10^9/L"|up to 54 months|Treated population who had at least one post baseline value||participants|||Number
718478|NCT00281528|Primary|Participant Counts of the Most Severe Grade for White Blood Cells (WBC) as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Experience (NCI CTCAE v3)|"Myelosuppression is a decrease in the ability of the bone marrow to produce blood cells. The lowest measured (nadir) WBC counts were graded using NCI CTCAE version 3:
Grade 0 = within normal limits; Grade 1 = < lower limit of normal -3.0*10^9/L; Grade 2 = <3.0 - 2.0*10^9/L; Grade 3 = <2.0 - 1.0*10^9/L; Grade 4 = <1.0*10^9/L"|up to 54 months|Treated population who had at least one post baseline value||participants|||Number
718479|NCT00281528|Secondary|Kaplan Meier Estimate for Participant Survival|Participant survival was summarized using Kaplan-Meier estimate of the time of first dose of study drug to the last known time that the participant was alive. Participants that were alive at the end of follow-up would be censored at the last known time that the patient was alive.|Up to 56 months|Treated population||Months||95% Confidence Interval|Median
718480|NCT00281528|Secondary|Kaplan Meier Estimate for Duration of Response|Duration of response was defined as the time from response to the time of disease progression for participants who achieve an objective confirmed complete (CR) or partial overall response (PR). Disease progression is based on the assessments by the investigator. Participants who did not have disease progression following a confirmed complete or partial target response were censored at the last known time that the participant was evaluated for response|Up to 43 months (until progressed)|Treated population who achieved a complete or partial response||Months||95% Confidence Interval|Median
718481|NCT00281528|Secondary|Kaplan Meier Estimate for Time to Disease Progression (TTP)|"Time to progression was defined as the time from the first dose of study drug to the start of progression. Participants that did not have progression were censored at the last known time the patient was evaluated for progression. Participants that initiate other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated.
Progressive disease was defined as at least a 20% increase in the sum of the longest diameters of target lesions; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion."|Up to 43 months (until progressed)|Treated population||Months||95% Confidence Interval|Median
718482|NCT00281528|Primary|Participant Counts of the Most Severe Grade for Absolute Neutrophil (ANC) as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Experience (NCI CTCAE v3)|"Myelosuppression is a decrease in the ability of the bone marrow to produce blood cells. The lowest measured (nadir) ANC counts were graded using NCI CTCAE version 3:
Grade 0 = within normal limits; Grade 1 = < lower limit of normal - 75.0*10^9L; Grade 2 = <1.5 - 1.0*10^9L; Grade 3 = <1.0 - 0.5*10^9L; Grade 4 = <0.5*10^9L"|up to 54 months|Treated population who had at least one post baseline value||participants|||Number
718483|NCT00281528|Secondary|Percentage of Participants With Stable Disease for ≥ 16 Weeks, or Complete or Partial Overall Response (i.e., Total Response) Based on Response Evaluation Criteria In Solid Tumors (RECIST v1.0)|"Using Response Evaluation Criteria in Solid Tumors (RECIST v1.0), the percentage of participants achieving either
A complete response (CR) defined as the disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation or
A partial response (PR) defined as at least a 30% decrease in the sum of the longest diameters of target lesions and no progression in non-target lesions or
Stable disease (SD) defined as neither sufficient shrinkage to qualify for PR or sufficient increase to qualify for progressive disease."|Up to 43 months (until progressed)|Treated population||Percent of Total Participants|||Number
718512|NCT00281580|Secondary|Change From Baseline in ABPM 24-hour Mean DBP|Observed results - key combination therapies|End-of-study (up to 8 weeks) visit (LOCF)|FAS-ABPM: all patients of the FAS that participated in the ambulatory blood pressure monitoring (ABPM) sub-study and had a successful APBM at both baseline and following treatment with target therapy.||mmHg||Standard Deviation|Mean
718484|NCT00281528|Primary|The Percentage of Participants Confirmed Complete Response (CR) or Partial Response (PR) Based on Response Evaluation Criteria In Solid Tumors (RECIST v1.0)|Using the RECIST response criteria version 1.0, the percent of participants achieving either a complete response (CR) defined as the disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation or partial response (PR) defined as at least a 30% decrease in the sum of the longest diameters of target lesions and no progression in non-target lesions based on confirmed responses from the investigator assessment of best overall response during study treatment.|Up to 43 months|Treated population||Percent of Total Participants|||Number
718485|NCT00281580|Secondary|Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG)|Clinical relevant abnormalities for laboratory parameters and Electrocardiogram (ECG). New abnormal findings or worsening of baseline conditions were reported as Adverse Events related to treatment (cardiac disorders and investigations).|8 weeks|Treated set||percentage of participants|||Number
718486|NCT00281580|Secondary|Change From Baseline in Seated Trough Pulse Rate|Observed results for mod-sev patients - key combination therapies|Up to 8 weeks (LOCF)|The full analysis set relating to the in-clinic trough pulse rate measurements included all treated patients that had at least one in-clinic pulse rate measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS).||bpm||Standard Deviation|Mean
718487|NCT00281580|Secondary|Orthostatic Change in Trough Cuff Mean SBP|Calculated as seated minus standing for mod-sev patients - key combination therapies|Week 8|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic systolic blood pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS).||mmHg||Standard Deviation|Mean
718488|NCT00281580|Secondary|Orthostatic Change in Trough Cuff Mean DBP|Calculated as seated minus standing for mod-sev patients - key combination therapies|Week 8|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS).||mmHg||Standard Deviation|Mean
718489|NCT00281580|Secondary|Change From Baseline in ABPM 24-hour Mean SBP|Observed results for mod-sev patients - key combination therapies|Up to 8 weeks (LOCF)|FAS-ABPM: all patients of the FAS that participated in the ambulatory blood pressure monitoring (ABPM) sub-study and had a successful APBM at both baseline and following treatment with target therapy.||mmHg||Standard Deviation|Mean
718490|NCT00281580|Secondary|Change From Baseline in ABPM 24-hour Mean DBP|Observed results for mod-sev patients - key combination therapies|Up to 8 weeks (LOCF)|FAS-ABPM: all patients of the FAS that participated in the ambulatory blood pressure monitoring (ABPM) sub-study and had a successful APBM at both baseline and following treatment with target therapy.||mmHg||Standard Deviation|Mean
718491|NCT00281580|Secondary|Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP|Observed results for mod-sev patients - key combination therapies|Up to 8 weeks (LOCF)|FAS-ABPM: all patients of the FAS that participated in the ambulatory blood pressure monitoring (ABPM) sub-study and had a successful APBM at both baseline and following treatment with target therapy.||mmHg||Standard Deviation|Mean
718492|NCT00281580|Secondary|BP Normality|"No: Mean seated SBP >=140 and/or mean seated DBP >=90 mmHg at trough High normal: mean seated SBP >=130 and <140 mmHg and mean seated DBP >=85 and <90 mmHg at trough Normal: mean seated SBP >=120 and <130 mmHg and mean seated DBP >=80 and <85 mmHg at trough Optimal: mean seated SBP < 120 mmHg and mean seated DBP <80 mmHg at trough
- key combination therapies"|Up to 8 weeks (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Systolic and Diastolic Blood Pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS)||percentage of participants|||Number
718493|NCT00281580|Secondary|SBP Response|SBP Response is defined as SBP < 140 mmHg or a reduction of SBP of >= 10 mmHg - key combination therapies|Up to 8 weeks (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Systolic Blood Pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS)||percentage of participants|||Number
718494|NCT00281580|Other Pre-specified|BP Control|Responders SBP<10 mmHg and DBP<90 mmHg) for mod-sev patients - key combination therapies|Up to 8 weeks (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic and systolic blood pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS).||percentage of participants|||Number
718495|NCT00281580|Secondary|DBP Response|DBP response is defined as DBP < 90 mmHg or a reduction of DBP of >= 10 mmHg - key combination therapies|Up to 8 weeks (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Diastolic Blood Pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS)||percentage of participants|||Number
718496|NCT00281580|Secondary|DBP Control|DBP control is defined as DBP < 90 mmHg - key combination therapies|Up to 8 weeks (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Diastolic Blood Pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS)||percentage of participants|||Number
718497|NCT00281580|Secondary|Change From Baseline in Standing Trough Cuff Mean SBP|Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline SBP included as a covariate.|Up to 8 weeks (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Systolic Blood Pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS)||mmHg||Standard Error|Least Squares Mean
719209|NCT00294684|Primary|The Percentage of Patients With Serum Total Bilirubin <1.5 mg/dL and With Native Liver at 6 Months After Portoenterostomy||Measurements will be made at 6 months after portoenterostomy|Intent to Treat||percentage of participants|||Number
718498|NCT00281580|Other Pre-specified|Change From Baseline in Seated Trough Cuff DBP|Observed results for mod-sev patients - key combination therapies|Nominal week over the trial|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS).||mmHg||Standard Deviation|Mean
718499|NCT00281580|Secondary|Change From Baseline in Standing Trough Cuff Mean DBP|Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.|Up to 8 weeks (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Diastolic Blood Pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS)||mmHg||Standard Error|Least Squares Mean
718500|NCT00281580|Secondary|Change From Baseline in Seated Trough Cuff Mean SBP|Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline SBP included as a covariate.|Up to 8 weeks (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Systolic Blood Pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS)||mmHg||Standard Error|Least Squares Mean
718501|NCT00281580|Secondary|Change From Baseline in Seated Trough Pulse Rate|Observed results for all patients - key combination therapies|End-of-study visit (LOCF)|The full analysis set relating to the in-clinic trough cuff Pulse Rate measurements included all treated patients that had at least one Pulse Rate measurement following treatment with target therapy (FAS-TC)||bpm||Standard Deviation|Mean
718502|NCT00281580|Primary|Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl)|Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.|Up to 8 weeks (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy and were identified as moderate or severe hypertension at baseline (FAS-TC-MS), excluding patients treated with placebo||mmHg||Standard Error|Least Squares Mean
718503|NCT00281580|Primary|Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects)|Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.|Up to 8 weeks (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS)||mmHg||Standard Error|Least Squares Mean
718504|NCT00281580|Primary|Change From Baseline in Seated Trough Cuff Mean DBP (Observed Treatment Effects)|Observed results|Up to 8 weeks (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS)||mmHg||Standard Deviation|Mean
718505|NCT00281580|Primary|Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Amlodipine Effects)|Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.|Up to 8 weeks (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS)||mmHg||Standard Error|Least Squares Mean
718506|NCT00281580|Primary|Change From Baseline in Seated Trough Cuff Mean DBP (Observed Amlodipine Effects)|Observed results|Up to 8 weeks (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS)||mmHg||Standard Deviation|Mean
718507|NCT00281580|Primary|Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Telmisartan Effects)|Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.|Baseline to end-of-study (up to 8 weeks) visit (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS).||mmHg||Standard Error|Least Squares Mean
718508|NCT00281580|Primary|Change From Baseline in Seated Trough Cuff Mean DBP (Observed Telmisartan Effect)|Observed results|Baseline to end-of-study (up to 8 weeks) visit (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS).||mmHg||Standard Deviation|Mean
718509|NCT00281580|Secondary|Orthostatic Change in Trough Cuff Mean SBP|Calculated as seated minus standing for all patients - key combination therapies|Week 8|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Systolic Blood Pressure measurement following treatment with target therapy (FAS-TC)||mmHg||Standard Deviation|Mean
718510|NCT00281580|Secondary|Orthostatic Change in Trough Cuff Mean DBP|Calculated as seated minus standing for all patients - key combination therapies|Week 8|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Diastolic Blood Pressure measurement following treatment with target therapy (FAS-TC)||mmHg||Standard Deviation|Mean
718511|NCT00281580|Secondary|Change From Baseline in ABPM 24-hour Mean SBP|Observed results - key combination therapies|End-of-study (up to 8 weeks) visit (LOCF)|FAS-ABPM: all patients of the FAS that participated in the ambulatory blood pressure monitoring (ABPM) sub-study and had a successful APBM at both baseline and following treatment with target therapy.||mmHg||Standard Deviation|Mean
718514|NCT00281580|Secondary|Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP|Observed results - key combination therapies|End-of-study (up to 8 weeks) visit (LOCF)|FAS-ABPM: all patients of the FAS that participated in the ambulatory blood pressure monitoring (ABPM) sub-study and had a successful APBM at both baseline and following treatment with target therapy.||mmHg||Standard Deviation|Mean
718515|NCT00281580|Secondary|BP Normality|"No: Mean seated SBP >=140 and/or mean seated DBP >=90 mmHg at trough High normal: mean seated SBP >=130 and <140 mmHg and mean seated DBP >=85 and <90 mmHg at trough Normal: mean seated SBP >=120 and <130 mmHg and mean seated DBP >=80 and <85 mmHg at trough Optimal: mean seated SBP < 120 mmHg and mean seated DBP <80 mmHg at trough
- key combination therapies"|End-of-study (up to 8 weeks) visit (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Systolic and Diastolic Blood Pressure measurement following treatment with target therapy (FAS-TC)||percentage of participants|||Number
718516|NCT00281580|Other Pre-specified|BP Control|Percentage of responders (SBP<140 mmHg and DBP<90 mmHg) for all patients - key combination therapies|End-of-study (up to 8 weeks) visit (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic and systolic blood pressure measurement following treatment with target therapy (FAS-TC).||percentage of participants|||Number
718517|NCT00281580|Secondary|SBP Response|SBP Response is defined as SBP < 140 mmHg or a reduction of SBP of >= 10 mmHg - key combination therapies|End-of-study (up to 8 weeks) visit (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Systolic Blood Pressure measurement following treatment with target therapy (FAS-TC)||percentage of participants|||Number
718518|NCT00281580|Secondary|DBP Response|DBP response is defined as DBP < 90 mmHg or a reduction of DBP of >= 10 mmHg - key combination therapies|End-of-study (up to 8 weeks) visit (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Diastolic Blood Pressure measurement following treatment with target therapy (FAS-TC)||percentage of participants|||Number
718519|NCT00281580|Secondary|DBP Control|DBP control is defined as DBP < 90 mmHg - key combination therapies|End-of-study (up to 8 weeks) visit (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Diastolic Blood Pressure measurement following treatment with target therapy (FAS-TC)||percentage of participants|||Number
718520|NCT00281580|Other Pre-specified|Change From Baseline at 2,4,6,and 8 Weeks in Seated Trough Cuff DBP|Observed results for key combination therapies|Baseline to nominal week over the trial|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy (FAS-TC).||mmHg||Standard Deviation|Mean
718521|NCT00281580|Secondary|Change From Baseline at 8 Weeks in Standing Trough Cuff Mean SBP|Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline SBP included as a covariate.|Baseline to end-of-study (up to 8 weeks) visit (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Systolic Blood Pressure measurement following treatment with target therapy (FAS-TC)||mmHg||Standard Error|Least Squares Mean
718522|NCT00281580|Secondary|Change From Baseline at 8 Weeks in Standing Trough Cuff Mean DBP|Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.|Baseline to end-of-study (up to 8 weeks) visit (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Diastolic Blood Pressure measurement following treatment with target therapy (FAS-TC)||mmHg||Standard Error|Least Squares Mean
718523|NCT00281580|Secondary|Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Systolic Blood Pressure (SBP)|Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline SBP included as a covariate.|Baseline to end-of-study (up to 8 weeks) visit (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Systolic Blood Pressure measurement following treatment with target therapy (FAS-TC)||mmHg||Standard Error|Least Squares Mean
718524|NCT00281580|Primary|Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl)|Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.|Baseline to end-of-study (up to 8 weeks) visit (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy (FAS-TC), excluding patients treated with placebo||mmHg||Standard Error|Least Squares Mean
718525|NCT00281580|Primary|Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects)|Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.|Baseline to end-of-study (up to 8 weeks) visit (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy (FAS-TC).||mmHg||Standard Error|Least Squares Mean
718526|NCT00281580|Primary|Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Treatment Effects)|Observed results|End-of-study visit (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy (FAS-TC).||mmHg||Standard Deviation|Mean
718527|NCT00281580|Primary|Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Amlodipine Effects)|Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.|Baseline to end-of-study (up to 8 weeks) visit (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy (FAS-TC).||mmHg||Standard Error|Least Squares Mean
718528|NCT00281580|Primary|Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Amlodipine Effects)|Observed results|Baseline to end-of-study (up to 8 weeks) visit (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy (FAS-TC).||mmHg||Standard Deviation|Mean
718529|NCT00281580|Primary|Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Telmisartan Effects)|Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.|Baseline to end-of-study (up to 8 weeks) visit (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy (FAS-TC).||mmHg||Standard Error|Least Squares Mean
718530|NCT00281580|Primary|Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Diastolic Blood Pressure (DBP) (Observed Telmisartan Effect)|Observed results|Baseline to end-of-study (up to 8 weeks) visit (Last Observation Carried Forward (LOCF))|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy (FAS-TC).||mmHg||Standard Deviation|Mean
718531|NCT00281632|Secondary|Mean Change From Baseline to Response in Lymphocytes, Neutrophils, Platelet Count, and White Blood Count|Change from baseline is calculated as the value at the time of response minus the value at Baseline.|Baseline to response (up to 3 years)|All participants. Data are presented for only those participants who provided hematology measurements at both baseline and the time of response.||giga (10^9) per liter (GI/L)||Standard Deviation|Mean
718532|NCT00281632|Secondary|Mean Change From Baseline to Response in Hemoglobin and Hematocrit|Change from baseline is calculated as the value at the time of response minus the value at Baseline.|Baseline to response (up to 3 years)|All participants. Data are presented for only those participants who provided hematology measurements at both baseline and the time of response.||g/L||Standard Deviation|Mean
718533|NCT00281632|Secondary|Mean Change From Baseline to Response in Thyroid Stimulating Hormone|Change from baseline is calculated as the value at the time of response minus the value at Baseline.|Baseline to response (up to 3 years)|All participants. Data are presented for only those participants who provided chemistry measurements at both baseline and the time of response.||milliunits per liter (MU/L)||Standard Deviation|Mean
718534|NCT00281632|Secondary|Mean Change From Baseline to Response in Thyroxine|Change from baseline is calculated as the value at the time of response minus the value at Baseline.|Baseline to response (up to 3 years)|All participants. Data are presented for only those participants who provided chemistry measurements at both baseline and the time of response.||nanomoles per liter (nmol/l)||Standard Deviation|Mean
718535|NCT00281632|Secondary|Mean Change From Baseline to Response in Calcium, Glucose, Potassium, Sodium, and Urea|Change from baseline is calculated as the value at the time of response minus the value at Baseline.|Baseline to response (up to 3 years)|All participants. Data are presented for only those participants who provided chemistry measurements at both baseline and the time of response.||millimoles per liter (mmol/l)||Standard Deviation|Mean
718536|NCT00281632|Secondary|Mean Change From Baseline to Response in Total Bilirubin and Creatinine|Change from baseline is calculated as the value at the time of response minus the value at Baseline.|Baseline to response (up to 3 years)|All participants. Data are presented for only those participants who provided chemistry measurements at both baseline and the time of response.||micromoles per liter (umol/l)||Standard Deviation|Mean
718537|NCT00281632|Secondary|Mean Change From Baseline to Response in Amylase and Lipase|Change from baseline is calculated as the value at the time of response minus the value at Baseline.|Baseline to response (up to 3 years)|All participants. Data are presented for only those participants who provided chemistry measurements at both baseline and the time of response.||Units per liter (U/L)||Standard Deviation|Mean
718538|NCT00281632|Secondary|Mean Change From Baseline to Response in Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, and Lactate Dehydrogenase|Change from baseline is calculated as the value at the time of response minus the value at Baseline.|Baseline to response (up to 3 years)|All participants. Data are presented for only those participants who provided chemistry measurements at both baseline and the time of response.||International Units per liter (IU/L)||Standard Deviation|Mean
718539|NCT00281632|Secondary|Mean Change From Baseline to Response in Albumin|Change from baseline is calculated as the value at the time of response minus the value at Baseline.|Baseline to response (up to 3 years)|All participants. Data are presented for only those participants who provided chemistry measurements at both baseline and the time of response.||grams per liter (g/L)||Standard Deviation|Mean
718540|NCT00281632|Secondary|Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Heart Rate|Summary of shifts in heart rate from baseline to the maximum change in the study. bpm, beats per minute.|Baseline to response (up to 3 years)|All participants||participants|||Number
718541|NCT00281632|Secondary|Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Systolic Blood Pressure|Summary of shifts in systolic blood pressure from baseline to the maximum change in the study. mmHg, millimeters of mercury.|Baseline to response (up to 3 years)|All participants. Data are presented for only those participants who provided measurements at baseline and maximum shift post-baseline.||participants|||Number
718542|NCT00281632|Secondary|Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Diastolic Blood Pressure|Summary of shifts in diastolic blood pressure from baseline to the maximum change in the study. mmHg, millimeters of mercury.|Baseline to response (up to 3 years)|All participants. Data are presented for only those participants who provided measurements at baseline and maximum shift post-baseline.||participants|||Number
718543|NCT00281632|Secondary|Overall Tumor Response|Overall tumor response following daily administration of pazopanib was defined using radiographic assessments based on Response Evaluation Criteria for Solid Tumors (RECIST) criteria for subjects with measurable disease at baseline.|Baseline to response (up to 3 years)|All participants||participants|||Number
718600|NCT00288587|Primary|Time Required for the Pulmonary Artery Occlusion Pressure (PAOP) to be Maintained at a Value of Less Than or Equal to 18 mmHg for at Least Four Consecutive Hours (+/- 30 Minutes) During the Intervention Period.||4 consecutive hours (+/- 30 minutes)|Analysis was performed on the intent-to-treat group which consisted of all patients enrolled in this study.||hours||Standard Deviation|Mean
718544|NCT00281632|Secondary|Median Progression-free Survival (PFS)|Progression-free survival analysis was performed on all participants and then stratified by CA-125 response status (having confirmed 50% reduction or not). PFS was defined as the time from the date of the first dose of study drug to the date of documented and confirmed progression by clinical, radiographic, or biochemical criteria, whichever occurred earliest, or to date of death due to any causes.|Date of the first dose of study drug to the date of documented and confirmed progression by clinical, radiographic, or biochemical criteria, whichever occurred earliest, or to date of death due to any causes (up to 2 years)|All participants with PFS||days||95% Confidence Interval|Median
718545|NCT00281632|Secondary|Overall Response and Stable Disease (SD)|Overall response and stable disease (SD) are based on biochemical, radiographic, and clinical assessments according to the modified criteria of Gynecologic Cancer Intergroup (GCIG) (see primary outcome). Response is presented as the percentage of participants with the given response.|Baseline to response (up to 3 years)|All participants||percentage of participants|||Number
718546|NCT00281632|Secondary|CA-125 Doubling Time Prior to and During Treatment With Pazopanib|CA-125 doubling time is defined as the time for CA-125 to double from baseline value. This measure was not reported, as no participants had a post-baseline CA-125 that was double the baseline value. Therefore, the data did not warrant a report.|Baseline to doubling of CA-125 (up to 3 years)|All participants with confirmed CA-125 50% reduction||hours||Standard Deviation|Mean
718547|NCT00281632|Secondary|Duration of Biochemical Response (CA-125)|Calculated as the date of confirmed first 50% or greater reduction in CA-125 to date of documented progression by clinical, radiographic, or biochemical criteria, whichever occurred earliest. This was calculated for all participants with confirmed CA-125 50% reduction.|Baseline to response (up to 3 years)|All participants with confirmed CA-125 50% reduction||days||95% Confidence Interval|Median
718548|NCT00281632|Secondary|Time to Biochemical Response (CA-125)|Time to biochemical response was calculated as the date pazopanib was first dosed to the date CA-125 was first reduced by 50% or greater. The reduction in CA-125 of 50% or greater was to be confirmed by a repeat measurement (no earlier than 21 days after initial evaluation documenting decrement). This was calculated for all participants with confirmed CA-125 50% reduction.|Baseline to response (up to 3 years)|All participants with confirmed CA-125 50% reduction||days||Full Range|Median
718549|NCT00281632|Primary|Best Biochemical Response (Cancer Antigen [CA-125])|Defined using modified Gynecologic Cancer Intergroup (GCIG) criteria: 50% response=≥50% decrease from baseline CA-125 (higher of 2 pretreatment CA-125 assessments) then confirmed after 21 days. 50% CA-125 response was normalized (CA-125 >21U/mL) or non-normalized (CA-125≤1U/mL). Progressive disease (PD) =CA-125 increase ≥100% from nadir (nadir >21U/mL) or ≥42U/mL (nadir ≤21U/mL); nadir was lowest CA-125. PD was confirmed after 21 days; otherwise=unconfirmed PD. Stable disease=scenarios that do not meet 50% response or PD. CA-125 response rate was defined as % of participants with 50% response.|Baseline to response (up to 3 years)|All participants||percentage of participants|||Number
718550|NCT00281658|Secondary|Number of Participants With a CR or PR at Weeks 8, 12, 16, 24, 32, 40, 48, 56, 64, and 72|The original outcome measure to be analyzed was time to response; however, data are presented as the number of participants with a response at each nominal visit. Responses are based on the investigator’s assessment, and only participants with a confirmed CR or PR were included in this analysis.|Weeks 8, 12, 16, 24, 32, 40, 48, 56, 64, and 72|Participants in the ITT Population with a confirmed CR or PR||participants|||Number
718551|NCT00281658|Secondary|Duration of Response|Duration of response is defined for the subset of participants with a confirmed CR or PR as the time from first documented evidence of CR or PR until the first documented sign of disease progression (radiological or clinical assessment of symptomatic progression) or death due to any cause during the randomized phase. Only participants with a confirmed CR or PR were included in this analysis. Disease progression is based on the assessments by the investigator.|Randomization to disease progression or death (up to a maximum of Month 53)|Participants in the ITT Population with a confirmed CR or PR||months||95% Confidence Interval|Median
718552|NCT00281658|Secondary|Clinical Benefit|Clinical benefit is defined as the number of participants achieving either a confirmed CR or PR or stable disease (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of >=1 new lesions], taking as reference the smallest sum LD since treatment start) of >=24 weeks, based on confirmed responses from the investigator assessment of best overall response during the randomized phase.|Randomization to disease progression or death (up to a maximum of Month 53)|ITT Population||participants|||Number
718553|NCT00281658|Secondary|Overall Response (OR)|OR, evaluated per Response Evaluation Criteria in Solid Tumors (RECIST), is defined as the number of participants achieving either a confirmed complete response (CR, disappearance of all target lesions) or partial response (PR, at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD) of tumor, which were based on confirmed responses from the investigator assessment of best OR during the randomized phase. Participants with unknown or missing responses were treated as non-responders.|Randomization to disease progression or death (up to a maximum of Month 53)|ITT Population||participants|||Number
718554|NCT00281658|Secondary|Progression-free Survival|Progression-free survival is defined as the time from randomization until the earliest date of disease progression (radiological or clinical assessment of symptomatic progression) or death due to any cause, if sooner during the randomized phase. Disease progression is based on the assessments by the investigator.|Randomization to disease progression or death (up to a maximum of Month 53)|ITT Population||months||95% Confidence Interval|Median
718555|NCT00281658|Primary|Overall Survival|Overall survival is defined as the time from randomization until death due to any cause.|Randomization to death (up to maximum of Month 53)|Intent-to-Treat (ITT) Population: all randomized participants||months||95% Confidence Interval|Median
718556|NCT00281697|Secondary|Duration of Objective Response|Duration of objective response was defined as the time from the initial response to documented disease progression or death from any cause, whichever occurred first. Duration of objective response was only analyzed in patients who achieved an objective response.|Baseline to data cut-off for analysis of the primary Outcome Measure (up to 3 years, 2 months)|Intent-to-treat population: All randomized patients, regardless of whether they received any study drug or completed the full course of treatment. Only patients who had measurable disease at baseline and achieved an objective response were included in the analysis.||Months||95% Confidence Interval|Median
718557|NCT00281697|Secondary|Objective Response|A patient had an objective response if they had a complete response or a partial response determined on two consecutive occasions ≥ 4 weeks apart as determined by the investigator using RECIST. For target lesions, a complete response was defined as the disappearance of all target lesions; a partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. For non-target lesions, a complete response was defined as the disappearance of all non-target lesions; a partial response was defined as the persistence of 1 or more non-target lesions.|Baseline to data cut-off for analysis of the primary Outcome Measure (up to 3 years, 2 months)|Intent-to-treat population: All randomized patients, regardless of whether they received any study drug or completed the full course of treatment. Only patients who had measurable disease at baseline were included in the analysis.||Percentage of patients||95% Confidence Interval|Number
718558|NCT00281697|Secondary|One-year Survival|Percentage of patients who survived 1 year in the study.|Baseline to the end of the study (up to 6 years, 7 months)|Intent-to-treat population: All randomized patients, regardless of whether they received any study drug or completed the full course of treatment.||Percentage of patients||95% Confidence Interval|Number
718559|NCT00281697|Secondary|Overall Survival|Overall survival was defined as the time from randomization to death from any cause.|Baseline to the end of the study (up to 6 years, 7 months)|Intent-to-treat population: All randomized patients, regardless of whether they received any study drug or completed the full course of treatment.||Months||95% Confidence Interval|Median
718560|NCT00281697|Secondary|Progression-free Survival Within Individual Standard Chemotherapy Cohorts (Taxanes, Gemcitabine, Capecitabine, and Vinorelbine)|Progression-free survival was defined as the time from randomization to first documented disease progression as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) or death due to any cause, whichever occurred first. Results are reported for each of the 4 standard chemotherapy cohorts used in the study.|Baseline to data cut-off for analysis of the primary Outcome Measure (up to 3 years, 2 months)|Intent-to-treat population: All randomized patients, regardless of whether they received any study drug or completed the full course of treatment.||Months||95% Confidence Interval|Median
718561|NCT00281697|Primary|Progression-free Survival|PFS was defined as the time from randomization to first documented disease progression (PD) as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) or death due to any cause, whichever occurred first. For target lesions, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Target lesions should be selected on the basis of their size (those with the longest diameter) and their suitability for accurate repeated measurements by imaging techniques or clinically. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions.|Baseline to data cut-off for analysis of the primary Outcome Measure (up to 3 years, 2 months)|Intent-to-treat population: All randomized patients, regardless of whether they received any study drug or completed the full course of treatment.||Months||95% Confidence Interval|Median
718562|NCT00281827|Secondary|Number of Patients Alive at 56 Months (End of Study)|Patients alive from date of enrollment to date of death or censored at date of last contact (Overall Survival).|Up to 56 months|Calculated from study entry date to date of death or censored at date of last contact.||Participants|||Number
718563|NCT00281827|Secondary|Number of Patients Alive at 2 Years (Survival)|Participants who were alive at 2 years from date of enrollment.|24 Months|Calculated from date of first date of enrollment to date of death.||Participants|||Number
718564|NCT00281827|Secondary|Number of Patients Alive at 1 Year (Survival)|Participants who were alive at one year from date of enrollment .|12 Months|Calculated from date of first date of enrollment.||Participants|||Number
718565|NCT00281827|Secondary|Number of Patients Disease-free at 2 Years|Calculated from date of enrollment to date of recurrence or death, whichever came first|2 Years|||Participants|||Number
718566|NCT00281827|Secondary|Number of Patients Disease-free at 1 Year|Calculated from date of enrollment to date of recurrence or death, whichever came first|1 year|Calculated from study entry date to date of recurrence or date of death, whichever came first.||Participants|||Number
718567|NCT00281827|Primary|Number of Patients Reporting Clinical Response|Objective clinical response measuring using tumor assessments: Complete Response (CR) = disappearance of all target and non-target lesions and normalization of tumor marker level, if applicable. Pathological Complete Response (PCR) = No viable tumor cells in specimen determined by light microscopy. Partial Response (PR) = at least 30% decrease in the sum of longest diameter of target lesions from baseline. Progressive Disease (PD) = at least 20% increase in the sum of longest diameters of target lesions from baseline or new lesions. Stable Disease (SD) = Neither PR or PD.|At end of 3 -21 day cycles of treatment|2 of 22 patients did not receive all 3 drugs for all 3 cycles - only 20 patients achieved this and are thereby included here in the evaluable population analysis.||Participants|||Number
718568|NCT00281840|Secondary|Response Rate|The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence. The patient's best response assignment will depend on the achievement of both measurement and confirmation criteria. Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST). A response will be determined by at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD|5 years|Patients with evaluable tumors at the end of the study||participants|||Number
718569|NCT00281840|Primary|Time to Progression|The time to disease progression is calculated from the date of treatment. Data for patients who remain disease progression free are censored as of date when the last follow-up information is obtained.|5 yrs after treatment|Patients who received at least one treatment on study||Months||95% Confidence Interval|Mean
718570|NCT00287716|Secondary|Worsening of Idiopathic Pulmonary Fibrosis (IPF)|"Worsening of IPF was defined by the occurrence of any of the following events:
Acute IPF exacerbation, IPF-related death, Lung transplantation, or Respiratory hospitalization."|Time to acute IPF exacerbation, IPF-related death, lung transplant or respiratory hospitalization, whichever comes first.|||Number of Patients Who Worsened|||Number
718571|NCT00287716|Secondary|Change in Dyspnea Score|The mean change from baseline to week 72 in Dyspnea score was measured by the University of San Diego Shortness of Breath Questionnaire (UCSD SOBQ). The SOBQ is used to assess shortness of breath with various activities of daily living (for example, brushing ones teeth or mowing the lawn). Patients rated the severity of their shortness of breath experienced on an average day during the past week on a 6 point scale (0 to 5), with 0 = not at all breathless, 4= severely breathless and 5 = Maximally or unable to do because of breathlessness.|Baseline to Week 72|||Change in Dyspnea Score||Standard Deviation|Mean
718572|NCT00287716|Primary|Absolute Change in Percent Predicted Forced Vital Capacity (FVC)|Mean Change in Percent Predicted Forced Vital Capacity (FVC) as measured from baseline to week 72.|From baseline up to 72 weeks|||Change in Percent Predicted FVC||Standard Deviation|Mean
718573|NCT00287716|Secondary|Change in Percent Predicted Hemoglobin (Hb)-Corrected Carbon Monoxide Diffusing Capacity (DLco) of the Lungs||Baseline to Week 72|||Change in Percent Predicted DLco||Standard Deviation|Mean
718574|NCT00287716|Secondary|Change in Worst Oxygen Saturation by Pulse Oximetry (SpO2) Measurement Observed During the 6-Minute Walk Test|The change from baseline to week 72 in worst oxygen saturation during the 6-Minute Walk Test as measure by Pulse Oximetry (SpO2) Level is calculated as the simple difference between baseline SpO2 measurements and week 72 SpO2 measurements.|Baseline to Week 72|||Change,Worst Oxygen Saturation (Percent)||Standard Deviation|Mean
718575|NCT00287716|Secondary|Change in Six-Minute Walk Test (6MWT)Distance|The change from Baseline to week 72 in distance walked during the 6-Minute Walk Test as measured in meters (m).|Baseline to Week 72|||Change in Distance Walked in Meters||Standard Deviation|Mean
718576|NCT00287716|Secondary|Progression-free Survival (PFS)|Progression is defined as the first occurrence of a 10% absolute decline from baseline in percent predicted Forced Vital Capacity, a 15% absolute decline from baseline in percent predicted hemoglobin(Hgb)-corrected carbon monoxide diffusing capacity (DLco), or, death.|Baseline to Week 72|||Number of Patients with Progression|||Number
718577|NCT00287716|Secondary|Categorical Assessment of Absolute Change in Percent Predicted Forced Vital Capacity (FVC)|Based on the change in baseline percent predicted FVC at week 72, patients were assigned to 1 of 5 categories: mild decline (<10% but >=0% decline), moderate decline (<20% but >=10% decline), severe decline (>=20% decline), mild improvement (>0% but <10% improvement), or moderate improvement (>=10% improvement). Those who died or had a lung transplant before Week 72 were included in the severe decline category. The results indicate the number of patients who experienced a Categorical Change in Percent Predicted Forced Vital Capacity.|baseline up to 72 weeks|||Patients|||Number
718578|NCT00287729|Secondary|Worsening of IPF|"Worsening of IPF was defined by the occurrence of any of the following events:
Acute IPF exacerbation, IPF-related death, Lung transplantation, or Respiratory hospitalization."|Time to acute IPF exacerbation, IPF-related death, lung transplant or respiratory hospitalization, whichever comes first.|A modified intent-to-treat population of all randomized patients who received any amount of study drug is used as the primary population for efficacy and safety analyses.||Number of Patients Who Worsened|||Number
718579|NCT00287729|Secondary|Change in Dyspnea Score|The mean change from baseline to week 72 in Dyspnea score was measured by the University of San Diego Shortness of Breath Questionnaire (UCSD SOBQ). The SOBQ is used to assess shortness of breath with various activities of daily living (for example, brushing ones teeth or mowing the lawn). Patients rated the severity of their shortness of breath experienced on an average day during the past week on a 6 point scale (0 to 5),with 0= not at all breathless, 4= severely breathless and 5= Maximally or unable to do because of breathlessness.|Baseline to Week 72|"A modified intent-to-treat population of all randomized patients who received any amount of study drug is used as the primary population for efficacy and safety analyses.
Missing data were imputed by the SSD method if the patient was alive and imputed to a score of 120 if the patient died before the protocol-specified time point."||Change in Dyspnea Score||Standard Deviation|Mean
718580|NCT00287729|Secondary|Change in Percent Predicted Hemoglobin (Hb)-Corrected Carbon Monoxide Diffusing Capacity (DLco) of the Lungs|The change from baseline to week 72 in Percent Predicted Hemoglobin (Hb)-Corrected Carbon Monoxide Diffusing Capacity (DLco) of the Lungs. It is calculated as the simple difference between baseline DLco measurements and week 72 DLco measurements.|Baseline to Week 72|A modified intent-to-treat population of all randomized patients who received any amount of study drug is used as the primary population for efficacy and safety analyses. Missing data were imputed by the SSD method if the patient was alive and imputed to 0% if the patient died before the protocol-specified time point.||Change in Percent Predicted DLco||Standard Deviation|Mean
718581|NCT00287729|Secondary|Change in Worst Oxygen Saturation by Pulse Oximetry (SpO2) Measurement Observed During the 6-Minute Walk Test|The change from baseline to week 72 in worst oxygen saturation during the 6-Minute Walk Test as measure by Pulse Oximetry (SpO2) Level. It is calculated as the simple difference between baseline SpO2 measurements and week 72 SpO2 measurements.|Baseline to Week 72|A modified intent-to-treat population of all randomized patients who received any amount of study drug is used as the primary population for efficacy and safety analyses. Missing data were imputed by the SSD method if the patient was alive and imputed to 83% if the patient died before the protocol-specified time point.||Change,Worst Oxygen Saturation (Percent)||Standard Deviation|Mean
718582|NCT00287729|Secondary|Change in the Six-Minute Walk Test (6MWT) Distance|The change from Baseline to week 72 in distance walked during the 6-Minute Walk Test. This measure was calculated as the simple difference between baseline distanced walked over 6 minutes and week 72 distance walked over 6 minutes as measured in meters (m).|Baseline to Week 72|A modified intent-to-treat population of all randomized patients who received any amount of study drug is used as the primary population for efficacy and safety analyses. Missing data were imputed by the SSD method if the patient was alive and imputed to 0 meters if the patient had died before the protocol-specified time point.||Change in Distance Walked in Meters||Standard Deviation|Mean
718583|NCT00287729|Secondary|Progression-free Survival|Progression is defined as the first occurrence of a 10% absolute decline from baseline in percent predicted Forced Vital Capacity, a 15% absolute decline from baseline in percent predicted hemoglobin(Hgb)-corrected carbon monoxide diffusing capacity (DLco), or, death.|Baseline to Week 72|A modified intent-to-treat population of all randomized patients who received any amount of study drug is used as the primary population for efficacy and safety analyses.||Number of Patients with Progression|||Number
718601|NCT00288600|Primary|Need of Exchange Transfusion|NEED OF EXCHANGE TRANSFUSION FOLLOWING GUIDELINES|10 DAYS OF LIFE|NUMBER||participants|||Number
718584|NCT00287729|Secondary|Categorical Assessment of Absolute Change in Percent Predicted Forced Vital Capacity|Based on the change in baseline percent predicted FVC at week 72, patients were assigned to 1 of 5 categories: mild decline (<10% but >=0% decline), moderate decline (<20% but >=10% decline), severe decline (>=20% decline), mild improvement (>0% but <10% improvement), or moderate improvement (>=10% improvement). Those who died or had a lung transplant before Week 72 were included in the severe decline category. The results indicate the number of patients who experience Categorical Change in Percent Predicted Forced Vital Capacity.|Baseline to week 72|A modified intent-to-treat population of all randomized patients who received any amount of study drug is used as the primary population for all efficacy and safety analyses. Missing data were imputed by the SSD method if the patient was alive and imputed to 0% if the patient died before the protocol-specified time point.||Patients|||Number
718585|NCT00287729|Primary|Absolute Change in Percent Predicted Forced Vital Capacity(FVC)|Mean Change in Percent Predicted Forced Vital Capacity (FVC) as measured from baseline to week 72. It is calculated as the simple difference between baseline Percent Predicted FVC measurements and week 72 Percent Predicted FVC measurements.|Baseline to week 72|A modified intent-to-treat population of all randomized patients who received any amount of study drug is the primary population for efficacy and safety analyses. Missing FVC data due to death were assigned the worst rank and missing FVC data due to reasons other than death were imputed using the SSD method.||Change in Percent Predicted FVC||Standard Deviation|Mean
718586|NCT00287872|Secondary|Quality of Life||0-6 months||||||
718587|NCT00287872|Secondary|The Time to Response||1-6 months||||||
718588|NCT00287872|Secondary|Mobilization of Stem Cells in Patients Proceeding to Autologous Peripheral Stem Transplantation||1-6 months||||||
718589|NCT00287872|Secondary|Peripheral Motor and Sensory Neuropathy (Grade 2 and Higher)|Neuropathy was monitored using Total Neuropathy Score reduced (TNSr).|1-6 months|||participants|||Number
718590|NCT00287872|Primary|Clinical Response to Treatment|Clinical evaluations of disease response were determined with each cycle. Bone marrow biopsies were done at baseline and at study termination. Clinical responses were defined by the International Myeloma Working Group criteria.|1-6 months|||persentage of participants||95% Confidence Interval|Number
718591|NCT00288509|Secondary|Toronto Western Spasmodic Torticollis Rating Scale Pain Subscale Score as a Change From Baseline|TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for pain is from 0 (no pain) to 20 (max pain). For each treatment cycle, the change in TWSTRS pain subscale is the score at week 4 minus the score at baseline.|Week 4 follow-up visit|"The intention to treat population consisted of all 108 subjects who received Dysport.
All available TWSTRS pain subscale scores have been included in the pain subscale analyses. Subjects excluded from the TWSTRS total score analyses may have their available data included in the TWSTRS pain subscale score analyses."||points on a scale||Standard Deviation|Mean
718592|NCT00288509|Secondary|Toronto Western Spasmodic Torticollis Rating Scale Disability Subscale Score as a Change From Baseline|TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for disability is from 0 (no disability) to 30 (max disability). For each treatment cycle, the change in TWSTRS disability subscale is the score at week 4 minus the score at baseline.|Week 4 follow-up visit|"The intention to treat population consisted of all 108 subjects who received Dysport.
All available TWSTRS disability subscale scores have been included in the disability subscale analyses. Subjects excluded from the TWSTRS total score analyses may have their available data included in the TWSTRS disability subscale score analyses."||points on a scale||Standard Deviation|Mean
718593|NCT00288509|Secondary|Toronto Western Spasmodic Torticollis Rating Scale Severity Subscale as a Change From Baseline|TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for severity is from 0 (absence of severity) to 35 (max severity). For each treatment cycle, the change in TWSTRS severity subscale is the score at week 4 minus the score at baseline.|Week 4 follow-up visit|"The intention to treat population consisted of all 108 subjects who received Dysport.
All available TWSTRS severity subscale scores have been included in the severity subscale analyses. Subjects excluded from the TWSTRS total score analyses may have their available data included in the TWSTRS severity subscale score analyses."||points on a scale||Standard Deviation|Mean
718594|NCT00288509|Primary|Change in Toronto Western Spasmodic Torticollis Rating Scale Total Score From Baseline|TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for each is the following: for severity from 0 (absence of severity) to 35 (max severity), for disability from 0 (no disability) to 30 (max disability) and for pain from 0 (no pain) to 20 (max pain). TWSTRS total score is the sum of the 3 component scores, with a range from 0 to a maximum of 85. For each treatment cycle, the change in TWSTRS total score is the score at week 4 minus the score at baseline.|Week 4 follow-up visit|"The intention to treat population consisted of all 108 subjects who received Dysport.
Subjects with incomplete TWSTRS scores were not included in the TWSTRS total score analyses."||points on a scale||Standard Deviation|Mean
718595|NCT00288574|Primary|Proportion of Patients Remaining in Study at 1 Year|The primary outcome measure was the proportion of patients with AN successfully completing 1 year of treatment and maintaining > 85% Ideal Body Weight.|12 months|||percentage of patients|||Number
718596|NCT00288587|Secondary|Composite Endpoint of Hospital Readmissions, Emergency Department Visits, and Deaths|Number of patients experiencing at least one of the composite endpoint measures within 90 days of hospital discharge.|Hospital discharge to 90 days after discharge|The analysis population is the intent-to-treat group which includes all patients enrolled on the study.||participants|||Number
718597|NCT00288587|Secondary|Volume Removal Rate.|Hours of therapy required to remove 1 liter of fluid normalized to body weight.|Intervention start to end.|The analysis population is the intent-to-treat group which includes all patients enrolled on the study.||milliliters/hour/kilogram||Standard Deviation|Mean
718598|NCT00288587|Secondary|Total Volume Removal During the Intervention Period||Intervention start to end.|The analysis population is the intent-to-treat group which includes all patients enrolled on the study.||milliliters||Standard Deviation|Mean
718599|NCT00288587|Secondary|Time to Discharge From the Heart Failure (HF) Unit, and Time to Discharge From the Hospital.||Time from admission to endpoint achievement|The analysis population was the intent-to-treat group, represented by all patients enrolled in this study.||Days||Standard Deviation|Mean
718602|NCT00288626|Secondary|Percent Change From Screening in Brain Volume|Magnetic resonance imaging (MRI) scan techniques measured ventricular volumes and grey and white matter brain volumes. Change from screening was computed as the value at the time point minus the screening value.|8 weeks to 5 years after HCT|Participants who received High-Dose Immunosuppressive Therapy (HDIT) and Autologous CD34+ Hematopoietic Stem Cell Transplant (HCT)||Percent Change||Standard Deviation|Mean
718603|NCT00288626|Secondary|Change From Baseline in T1-Weighted Lesion Volume|A T1-weighted magnetic resonance imaging (MRI) scan was used to assess the volume of T1 lesions in the brain. Change from baseline was computed as the value at the time point minus the baseline value.|8 weeks to 5 years after HCT|Participants who received High-Dose Immunosuppressive Therapy (HDIT) and Autologous CD34+ Hematopoietic Stem Cell Transplant (HCT)||milliliter||Standard Deviation|Mean
718604|NCT00288626|Secondary|Change From Baseline in T2-Weighted Lesion Volume|A T2-weighted magnetic resonance imaging (MRI) scan was used to assess the volume of T2 lesions in the brain. Change from baseline was computed as the value at the time point minus the baseline value.|8 weeks to 5 years after HCT|Participants who received High-Dose Immunosuppressive Therapy (HDIT) and Autologous CD34+ Hematopoietic Stem Cell Transplant (HCT)||milliliters||Standard Deviation|Mean
718605|NCT00288626|Secondary|Number of New T2-Weighted Lesions From Baseline|A T2-weighted magnetic resonance imaging (MRI) scan was used to determine the number of new T2 lesions in the brain relative to Baseline. A value of 0 means that the participant didn’t worsen. Values greater than 0 indicate an increase in disease activity from baseline.|6 Months to 5 years after HCT|Participants who received High-Dose Immunosuppressive Therapy (HDIT) and Autologous CD34+ Hematopoietic Stem Cell Transplant (HCT)||Lesions per scan||Standard Deviation|Mean
718606|NCT00288626|Secondary|Change From Baseline in Number of Gadolinium-Enhanced Lesions|Multiple sclerosis disease-related lesions were assessed by gadolinium-enhanced magnetic resonance imaging (MRI). Change from baseline was computed as the value at the time point minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening.|8 weeks to 5 years after HCT|Participants who received High-Dose Immunosuppressive Therapy (HDIT) and Autologous CD34+ Hematopoietic Stem Cell Transplant (HCT)||Lesions per scan||Standard Deviation|Mean
718607|NCT00288626|Secondary|Change From Baseline in Extended Disability Status Scale (EDSS)|Kurtzke’s Expanded Disability Status Scale (EDSS) assesses disability in Multiple Sclerosis patients. Eight functional systems are evaluated: visual, brain stem, pyramidal, cerebellar, sensory, bowel and bladder, cerebral, and ambulation. The overall score ranges from 0 (normal neurological exam) to 10 (death due to MS). Change from baseline was computed as the value at the time point minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening. A change of > 0.5 in EDSS was a treatment-failure criterion.|6 months to 5 years after HCT|Participants who received High-Dose Immunosuppressive Therapy (HDIT) and Autologous CD34+ Hematopoietic Stem Cell Transplant (HCT)||units on a scale||Standard Deviation|Mean
718608|NCT00288626|Secondary|Disease-Modifying Therapy Survival Probability After Transplant|Treatment with disease-modifying therapy was measured by the number of days from transplant to the first treatment with an additional disease-modifying therapy. Examples of therapy include interferon beta-1a, glatiramer acetate, natalizumab, alemtuzumab, other immunosuppressive medications, or experimental therapies directed against MS activity. Kaplan-Meier estimates of survival probability, with 90% confidence interval based on Greenwood’s formula for standard error.|1 to 5 years after HCT|Participants who received High-Dose Immunosuppressive Therapy (HDIT) and Autologous CD34+ Hematopoietic Stem Cell Transplant (HCT)||Probability||90% Confidence Interval|Number
718609|NCT00288626|Secondary|MS Relapse-Free Survival Probability After Transplant|"MS clinical relapse is defined as the development of a new neurological sign and corresponding symptom, or worsening of an existing neurological sign and symptom, localized to central nervous system white matter, resulting in neurological deficit or disability, and lasting over 48 hours. Clinical relapse was determined by the participant’s neurologist and was measured as days from transplant to new or worsening neurological symptom relative to baseline.
Kaplan-Meier estimates of survival probability, with 90% confidence interval based on Greenwood’s formula for standard error."|1 to 5 years after HCT|Participants who received High-Dose Immunosuppressive Therapy (HDIT) and Autologous CD34+ Hematopoietic Stem Cell Transplant (HCT)||Probability||90% Confidence Interval|Number
718610|NCT00288626|Secondary|MRI Activity-Free Survival Probability After Transplant|MS disease activity is measured as days from transplant to first occurrence of >= 2 new MS lesions on Magnetic resonance imaging (MRI) relative to baseline. Kaplan-Meier estimates of survival probability, with 90% confidence intervals based on Greenwood’s formula for standard error.|1 to 5 years after HCT|Participants who received High-Dose Immunosuppressive Therapy (HDIT) and Autologous CD34+ Hematopoietic Stem Cell Transplant (HCT)||Probability||90% Confidence Interval|Number
718611|NCT00288626|Secondary|MS Progression-Free Survival Probability After Transplant|"MS progression is measured as number of days from transplant to first Kurtzke’s Expanded Disability Status Scale (EDSS) increase of more than 0.5 relative to the baseline measurement. EDSS assesses disability in Multiple Sclerosis patients. Eight functional systems are evaluated: visual, brain stem, pyramidal, cerebellar, sensory, bowel and bladder, cerebral, and ambulation. The overall score ranges from 0 (normal neurological exam) to 10 (death due to MS).
Kaplan-Meier estimates of survival probability, with 90% confidence intervals based on Greenwood’s formula for standard error."|1 to 5 years after HCT|Participants who received High-Dose Immunosuppressive Therapy (HDIT) and Autologous CD34+ Hematopoietic Stem Cell Transplant (HCT)||Probability||90% Confidence Interval|Number
718612|NCT00288626|Secondary|Event-Free Survival Probability After Transplant|Event-free survival (EFS) is survival without death or disease activity from any one of the following criteria: 1) loss of neurological function, defined as a change in pretransplant Extended Disability Status Scale (EDSS) of > 0.5. 2) Relapse, defined as the development of a new neurological sign and corresponding symptom, or worsening of an existing neurological sign and symptom, localized to central nervous system white matter, resulting in neurological deficit/disability, and lasting over 48 hours. 3) New lesions on magnetic resonance imaging (MRI), defined as presence of 2 or more independent multiple sclerosis brain lesions detected on MRI 1 year or more after stem cell transplant. Kaplan-Meier estimates of survival probability, with 90% confidence intervals based on Greenwood’s formula for standard error.|1, 2, and 4 years after HCT|Participants who received High-Dose Immunosuppressive Therapy (HDIT) and Autologous CD34+ Hematopoietic Stem Cell Transplant (HCT)||Probability||90% Confidence Interval|Number
718613|NCT00288626|Secondary|Time to Platelet Engraftment|Platelet engraftment, or platelet count recovery, is defined as Platelets > 20,000/μL for two consecutive measurements on different days with no platelet transfusions in the preceding 7 days. Normal range is 150,000-450,000/μL. Reference: http://www.hopkinsmedicine.org/heart_vascular_institute/clinical_services/centers_excellence/womens_cardiovascular_health_center/patient_information/health_topics/platelets.html.|From time of graft infusion to time of engraftment, up to 6 years|Participants who received High-Dose Immunosuppressive Therapy (HDIT) and Autologous CD34+ Hematopoietic Stem Cell Transplant (HCT)||Days||Standard Deviation|Mean
718614|NCT00288626|Secondary|Time to Neutrophil Engraftment|Neutrophil engraftment, or neutrophil count recovery, is defined as an Absolute Neutrophil Count (ANC) > 500/ μL for 2 consecutive measurements on different days. Normal range is 1500 to 8000/μL. Reference: http://www.medicinenet.com|From time of graft infusion to time of engraftment, up to 6 years|Participants who received High-Dose Immunosuppressive Therapy (HDIT) and Autologous CD34+ Hematopoietic Stem Cell Transplant (HCT)||Days||Standard Deviation|Mean
718615|NCT00288626|Secondary|Percent of Participants Who Experienced All-Cause Morbidity Within 12 Months of Post-HCT|Morbidity is the occurrence of NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0 adverse event grade 3 or higher.|From the time of Autologous CD34+ Hematopoietic Stem Cell Transplant (HCT) to 1 year after HCT.|Participants who received High-Dose Immunosuppressive Therapy (HDIT) and Autologous CD34+ Hematopoietic Stem Cell Transplant (HCT).||Percentage of Participants|||Number
718616|NCT00288626|Secondary|Percent of Participants Who Experienced All-Cause Morbidity|Morbidity is the occurrence of NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0 adverse event grade 3 or higher.|From the time of enrollment until completion of the 5-year follow-up, an average of 6 years.|Participants who received High-Dose Immunosuppressive Therapy (HDIT) and Autologous CD34+ Hematopoietic Stem Cell Transplant (HCT)||percentage of participants|||Number
718617|NCT00288626|Secondary|Survival From MS-Related Mortality|The probability that a participant did not experienced a MS-related death estimated at 1, 2, 3, 4, and 5 years following transplant via the Kaplan-Meier Method. Greenwood’s formula for standard error was used to calculate 90% confidence intervals. Participants that did not experience a MS-related death were censored at the time of last follow-up. A MS-related death was defined as death that occurred at any time after study entry and that was possibly, probably, or definitely related to disease progression.|From study entry to death, loss to follow-up, or the end of the study, whichever came first, up to 6 years|Participants who received High-Dose Immunosuppressive Therapy (HDIT) and Autologous CD34+ Hematopoietic Stem Cell Transplant (HCT)||Probability||90% Confidence Interval|Number
718618|NCT00288626|Secondary|Overall Survival|The probability that a participant did not experienced a death estimated at 1, 2, 3, 4, and 5 years following transplant via the Kaplan-Meier Method. Greenwood’s formula for standard error was used to calculate 90% confidence intervals. Participants that did not die were censored at the time of last follow-up.|From study entry to death, loss to follow-up, or the end of the study, whichever came first, up to 6 years|Participants who received High-Dose Immunosuppressive Therapy (HDIT) and Autologous CD34+ Hematopoietic Stem Cell Transplant (HCT)||Probability||90% Confidence Interval|Number
718619|NCT00288626|Secondary|Survival From Treatment-Related Mortality|The probability that a participant did not experienced a treatment-related death estimated at 1, 2, 3, 4, and 5 years following transplant via the Kaplan-Meier Method. Greenwood’s formula for standard error was used to calculate 90% confidence intervals. Participants that did not experience a treatment-related death were censored at the time of last follow-up. A treatment-related death was defined as death that occurred at any time after study entry and that was possibly, probably, or definitely related to the cellular product or possibly, probably, or definitely related to mobilization of autologous peripheral blood hematopoietic progenitor cells with G-CSF and prednisone or to the high-dose immunosuppressive therapy. There were no treatment-related mortality events in the study.|From study entry to death, loss to follow-up, or the end of the study, whichever came first, up to 6 years|Participants who received High-Dose Immunosuppressive Therapy (HDIT) and Autologous CD34+ Hematopoietic Stem Cell Transplant (HCT).||Probability||90% Confidence Interval|Number
718620|NCT00288626|Secondary|Event-Free Survival Probability During the 3 Years After Transplant|Event-free survival (EFS) is survival without death or disease activity from any one of the following criteria: 1) loss of neurological function, defined as a change in pretransplant Extended Disability Status Scale (EDSS) of > 0.5. 2) Relapse, defined as the development of a new neurological sign and corresponding symptom, or worsening of an existing neurological sign and symptom, localized to central nervous system white matter, resulting in neurological deficit/disability, and lasting over 48 hours. 3) New lesions on magnetic resonance imaging (MRI), defined as presence of 2 or more independent multiple sclerosis brain lesions detected on MRI 1 year or more after stem cell transplant. Kaplan-Meier estimates of survival probability, with 90% confidence interval based on Greenwood’s formula for standard error.|3 years|Participants who received High-Dose Immunosuppressive Therapy (HDIT) and Autologous CD34+ Hematopoietic Stem Cell Transplant (HCT).||Probability||90% Confidence Interval|Number
718621|NCT00288626|Primary|Event-Free Survival Probability During the 5 Years After Transplant|Event-free survival (EFS) is survival without death or disease activity from any one of the following criteria: 1) loss of neurological function, defined as a change in pretransplant Extended Disability Status Scale (EDSS) of > 0.5. 2) Relapse, defined as the development of a new neurological sign and corresponding symptom, or worsening of an existing neurological sign and symptom, localized to central nervous system white matter, resulting in neurological deficit/disability, and lasting over 48 hours. 3) New lesions on magnetic resonance imaging (MRI), defined as presence of 2 or more independent multiple sclerosis brain lesions detected on MRI 1 year or more after stem cell transplant. Kaplan-Meier estimates of survival probability, with 90% confidence interval based on Greenwood’s formula for standard error.|5 years|Participants who received High-Dose Immunosuppressive Therapy (HDIT) and Autologous CD34+ Hematopoietic Stem Cell Transplant (HCT).||Probability||90% Confidence Interval|Number
718622|NCT00288639|Secondary|Subjects Assessment of Optimal Sleep|Number of subjects that responded optimal or non-optimal sleep in Optimal Sleep subscale of Medical Outcomes Study (MOS) Sleep scale.|Baseline, End of 21-week treatment|Full analysis set (FAS)/intent-to-treat (ITT) population (all subjects who received at least 1 dose of study treatment & had a minimum of 2 partial seizures during baseline period).||participants|||Number
718624|NCT00288639|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale(HADS) Depression and Anxiety Symptoms Subscales Between Baseline and Week 21.|Change in total HADS score between Baseline and Week 21. Each of the 14 items is scored 0, 1, 2 or 3 where a score of 3 corresponds to the most anxious/depressed. 7-item depression and 7-item anxiety subscales are summed; each resulting in a total score of 0-21.|Baseline, End of 21-week treatment|"Full analysis set (FAS)/intent-to-treat (ITT) population (all subjects who received at least 1 dose of study treatment & had a minimum of 2 partial seizures during baseline period). n is the number of subjects contributing to the mean at the specified time point."||score on scale||95% Confidence Interval|Mean
718625|NCT00288639|Secondary|Changes From Baseline in Medical Outcomes Study (MOS) Sleep Scale Scores|Subjects recall sleep related activities over the previous 4 weeks. Low scores reflect greater impairment (except sleep adequacy, optimal sleep, &quantity). Range = 0 - 100 for Sleep Disturbance, Snoring, Awaken Short of Breath, Sleep Adequacy, Somnolence, & Sleep Problems Index. Quantity of Sleep Range = 0 - 24. Optimal Sleep Range 0 – 1.|Baseline, end of 21-week treatment|"Full analysis set (FAS)/intent-to-treat (ITT) population (all subjects who received at least 1 dose of study treatment & had a minimum of 2 partial seizures during baseline period). n is the number of subjects contributing to the mean at the specified time point."||score on scale||95% Confidence Interval|Mean
718626|NCT00288639|Secondary|Subjects With Categorical Impression of Change in Overall Status Using the Clinical Global Impression of Change (CGIC)|The CGIC is a clinician’s judgment of the overall change in the patient’s condition over a defined period on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).|End of 21-week treatment|Full analysis set (FAS)/intent-to-treat (ITT) population (all subjects who received at least 1 dose of study treatment and had a minimum of 2 partial seizures during the baseline period).||partcipants|||Number
718627|NCT00288639|Secondary|Impression of Change in Overall Status Using the Patient Global Impression of Change (PGIC)|The PGIC is a patient-rated instrument that measures change in patient’s overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).|End of 21-week treatment|Full analysis set (FAS)/intent-to-treat (ITT) population (all subjects who received at least 1 dose of study treatment and had a minimum of 2 partial seizures during the baseline period).||participants|||Number
718628|NCT00288639|Secondary|Change in Partial Seizure Frequency (All Partial Seizure Types) Between Baseline and the 12 Week Observation Period Categorized by Baseline Seizure Frequency|Percentage change from baseline = ((12 weeks - 8 weeks)/8 weeks)*100. Negative mean R-Ratios and associated 95% CIs that do not include zero indicate reduction in partial seizure frequency.|8 week baseline observation period & 12 week treatment observation period|Full analysis set (FAS)/intent-to-treat (ITT) (all subjects who received at least 1 dose of study treatment & minimum 2 partial seizures during baseline pd). Seizure rate was calculated on last observation carried forward (LOCF) basis, whereby data from last 84 days prior to last dose was used to calculate seizure frequency.||percentage change in events||Full Range|Median
718629|NCT00288639|Secondary|Subjects Achieving Seizure Freedom During Observation Period|Number of subjects achieving seizure freedom (no seizures) during last 4 weeks or duration of 12 week observation period.|Day 147 from the first dose of study drug|Full analysis set (FAS)/intent-to-treat (ITT) population (all subjects who received at least 1 dose of study treatment & had a minimum of 2 partial seizures during baseline period).||participants|||Number
718630|NCT00288639|Secondary|Reduction in Partial Seizure Frequency Between Baseline and the Final 4 Weeks of the Observation Period.|Number of subjects with at least a 50% or 75% reduction in partial seizure frequency between baseline and treatment period.|8 week baseline observation period & last 4 weeks of observation period|Full analysis set (FAS)/intent-to-treat (ITT) population (all subjects who received at least 1 dose of study treatment & had a minimum of 2 partial seizures during baseline period). Patients who discontinued less than 4 weeks into the observation period (after Visit 3/week 9) will be regarded as missing. No data prior to week 9 will be used.||participants|||Number
718631|NCT00288639|Secondary|Number of Subjects Seizure-free|Count of subjects seizure free during the period.|last 4 weeks & whole 12 week treatment observation period|Full analysis set(FAS)/intent-to-treat(ITT) all subjects who received >= 1 dose of study Tx & >= 2 partial seizures during baseline pd. LOCF if subjects withdrew then last 4 wks prior to last dose (but after visit 3). 12 wk subjects who withdrew were regarded as missing. n= # subjects evaluable for seizure freedom during defined observation pd.||participants|||Number
718632|NCT00288639|Post-Hoc|Change in Partial Seizure Frequency by Type Between the 8 Week Baseline Period and During the 12 Week Observation Period.|Change from baseline = 12 week treatment observation period seizure frequency rate minus 8 week baseline period seizure frequency rate.|8 week baseline period & 12 week treatment observation period|Full analysis set (FAS)/intent-to-treat (ITT) population (all subjects who received at least 1 dose of study treatment & had a minimum of 2 partial seizures during baseline period). Seizure rate was calculated on last observation carried forward (LOCF) basis, whereby data from last 84 days prior to last dose was used to calculate seizure frequency.||change in median partial seizures||Full Range|Median
718633|NCT00288639|Secondary|Percentage Change in Partial Seizure Frequency (All Partial Seizure Types) Between the 8 Week Baseline Period and 4 Week Intervals During the 21 Week Open-label Treatment Period.|Percentage change from baseline = [(4 week seizure frequency minus 8 week baseline) / (8 week baseline seizure frequency)] x 100. Negative mean R-Ratios and associated 95% CIs that do not include zero indicate reduction in partial seizure frequency.|8 week baseline period and 21 week treatment period|Full analysis set (FAS)/intent-to-treat (ITT) population (all subjects who received at least 1 dose of study treatment & had a minimum of 2 partial seizures during baseline period). Seizure date from patients who discontinued during any of these 4 week intervals will not be included in the summary for that interval.||percentage change of events||Full Range|Median
718634|NCT00288639|Secondary|Percentage Change in Partial Seizure Frequency (All Partial Seizure Types) Between Baseline and the Whole 21 Week Open-label Treatment Period.|Percentage change from baseline = ((21 weeks-8 weeks)/8 weeks)*100. Negative mean R-Ratios and associated 95% CIs that do not include zero indicate reduction in partial seizure frequency.|8 week baseline period and 21 week treatment period|Full analysis set (FAS)/intent-to-treat (ITT) population (all subjects who received at least 1 dose of study treatment & had a minimum of 2 partial seizures during baseline period). Seizure rate was calculated on last observation carried forward (LOCF) basis, whereby data from last 84 days prior to last dose was used to calculate seizure frequency.||percentage change in events||Full Range|Median
718635|NCT00288639|Primary|Percentage Change in Partial Seizure Frequency (All Partial Seizure Types) Between Baseline and the 12 Week Observation Period|Percentage change from baseline=[(12 week treatment observation period seizure frequency rate minus 8 week baseline period seizure frequency rate)/ 8 week baseline period seizure frequency rate] x 100. Seizure frequencies per 28-day period: = (total # of partial seizures in period x 28 / (total # of days in period).|8 week baseline period & 12 week treatment observation period|Full analysis set (FAS)/intent-to-treat (ITT) population (all subjects who received at least 1 dose of study treatment & had a minimum of 2 partial seizures during baseline period). Seizure rate was calculated on last observation carried forward (LOCF) basis, whereby data from last 84 days prior to last dose was used to calculate seizure frequency.||percentage change in events||Full Range|Median
718636|NCT00288704|Other Pre-specified|Change From Baseline to Open-Label Extension Week 72 in Number of Disease Flare Days|"OLE Week 72 was the last timepoint at which efficacy was measured in the study. 56 of the 101 OLE subjects were included in the analysis.
A Disease flare day was any day where the mean Key Symptom Score (KSS) was greater than 3. The mean Key Symptom Score (KSS --from the validated, patient-administered Daily Health Assessment Form(DHAF)) was the average on a 0-10 scale (0=None, 10=Very Severe) of 5 separate scales -- rash, feeling of fever/chills, joint pain, eye redness/pain, and fatigue)."|From Baseline (Week 0) to OLE Week 72|44 subjects entered from part A of the study, and 12 subjects entered directly into the OLE. No placebo subjects were in the OLE.||Number of Days||Standard Deviation|Mean
718637|NCT00288704|Other Pre-specified|Change From Baseline to Open-Label Extension Week 72 in Patient's Global Assessment|"The Patient's Global Assessment was a question on the Daily Health Assessment Form Considering all the ways that FCAS/MWS affects you, please rate how you are doing based on the following scale 0=very well to 10=very poor. A negative value in change in Patient's Global Assessment is indicative of an improvement.
OLE Week 72 was the last timepoint at which efficacy was measured in the study. 56 of the 101 OLE subjects were included in the analysis."|From Baseline (Week 0) to OLE Week 72|44 subjects entered from part A of the study, and 12 subjects entered directly into the OLE. No placebo subjects were in the OLE.||Units of a Scale||Standard Deviation|Mean
718638|NCT00288704|Other Pre-specified|Summary of Mean Change From Baseline to Open-Label Extension Week 72 in KSS|"OLE Week 72 was the last timepoint at which efficacy was measured in the study. 56 of the 101 OLE subjects were included in the analysis.
The mean Key Symptom Score (KSS --from the validated, patient-administered Daily Health Assessment Form(DHAF)) was the average on a 0-10 scale (0=None, 10=Very Severe) of 5 separate scales -- rash, feeling of fever/chills, joint pain, eye redness/pain, and fatigue).
A negative change in mean values indicated improvement in symptoms."|From Baseline (week 0) to OLE Week 72|44 subjects entered from part A of the study, and 12 subjects entered directly into the OLE. No placebo subjects were in the OLE.||Units of a scale||Standard Deviation|Mean
718639|NCT00288704|Other Pre-specified|Number of Subjects With at Least 75% Improvement in Key Symptoms Scores (KSS) From Baseline to Endpoint (Week 6)|The mean Key Symptom Score (KSS --from the validated, patient-administered Daily Health Assessment Form(DHAF)) was the average on a 0-10 scale (0=None, 10=Very Severe) of 5 separate scales -- rash, feeling of fever/chills, joint pain, eye redness/pain, and fatigue).|Baseline to Week 6 (Part A)|||Participants|||Number
718640|NCT00288704|Other Pre-specified|Number of Subjects With at Least 50% Improvement in Key Symptoms Scores (KSS) From Baseline to Endpoint (Week 6)|The mean Key Symptom Score (KSS --from the validated, patient-administered Daily Health Assessment Form(DHAF)) was the average on a 0-10 scale (0=None, 10=Very Severe) of 5 separate scales -- rash, feeling of fever/chills, joint pain, eye redness/pain, and fatigue).|Baseline to Week 6 (Part A)|||Participants|||Number
718641|NCT00288704|Other Pre-specified|Number of Subjects With at Least 30% Improvement in Key Symptoms Scores (KSS) From Baseline to Endpoint (Week 6)|The mean Key Symptom Score (KSS --from the validated, patient-administered Daily Health Assessment Form(DHAF)) was the average on a 0-10 scale (0=None, 10=Very Severe) of 5 separate scales -- rash, feeling of fever/chills, joint pain, eye redness/pain, and fatigue).|Baseline to Endpoint (Week 6)|||Participants|||Number
718642|NCT00288704|Other Pre-specified|Median Change From Baseline to Week 6 (Part A) Endpoint in Serum Amyloid A (mg/L)|An abnormal value for SAA was considered > 6.4 mg/L.|Baseline to Endpoint of Part A|||Milligrams per Liter||Standard Deviation|Median
718643|NCT00288704|Other Pre-specified|Median Change From Baseline to Week 6 (Part A) Endpoint in C-Reactive Protein (mg/L)|An abnormal value for CRP was considered > 8.4 mg/L.|Baseline to Endpoint of Part A|||Milligrams per Liter||Standard Deviation|Median
718644|NCT00288704|Other Pre-specified|Mean Change From Baseline to Endpoint (Week 6) in Patient's Global Assessment|"The Patient's Global Assessment was a question on the Daily Health Assessment Form Considering all the ways that Familial Cold Autoinflmatory Syndrome (FCAS) /Muckle-Wells Syndrome (MWS) affects you, please rate how you are doing based on the following scale 0=very well to 10=very poor. A negative value in change in Patient's Global Assessment is indicative of an improvement."|Baseline to Week 6 (Part A)|||Visual Analog Scale||Standard Deviation|Mean
718645|NCT00288704|Other Pre-specified|Change From Baseline to Endpoint (Week 6) in Physician's Global Assessment|The Physician's Global Assessment was an evaluation at each visit on a scale of 0=no disease activity to 10=severe disease activity. A negative value in change in Physician's Global Assessment is indicative of an improvement.|Baseline to Week 6 (Part A)|||Units of a Scale||Standard Deviation|Mean
718646|NCT00288704|Other Pre-specified|Mean Change From Baseline to Endpoint (Week 6) in Number of Disease Flare Days Per Patient|"A Disease flare day was any day where the mean Key Symptom Score (KSS) was greater than 3. The KSS was the average on a 0-10 scale (0=None, 10=Very Severe) of 5 separate scales -- rash, feeling of fever/chills, joint pain, eye redness/pain, and fatigue). KSS was calculated for 21 Day Periods at baseline and at the endpoint (from Weeks 3 - 6). The difference in the number of flares between the two periods was averaged for all subjects.
The DHAF was used because it is a validated instrument to collect subject's self-reported responses. It was the basis for the KSS and the flare day count."|Baseline to Week 6 (Part A)|||Days||Standard Deviation|Mean
718661|NCT00288912|Secondary|AIMS 2 Physical Function|The AIMS2 physical function subscale includes 28 items that measure aspects of mobility, walking and bending, hand and finger function, arm function, self-care, and household tasks. All items on the AIMS2 physical function subscale are measured on a 5-point Likert scale (“all days” to “no days”). Scores can range from 0-10, with higher scores indicating worse function.|Baseline and 12-month follow-up|||units on a scale||Standard Deviation|Mean
718647|NCT00288704|Primary|Mean Change in Key Symptom Score (KSS) From Week 15 to Week 24 (During the Randomized Withdrawal Phase or Part B)|"The mean Key Symptom Score (KSS --from the validated, patient-administered DHAF) was the average on a 0-10 scale (0=None, 10=Very Severe) of 5 separate scales -- rash, feeling of fever/chills, joint pain, eye redness/pain, and fatigue).
Subjects all received rilonacept 160 mg from week 6 through week 14. At week 15, subjects were re-randomized in a 1:1 ratio between Placebo and rilonacept 160 mg. Subjects baseline period was the 21-day period prior to week 15 randomization.
A positive score indicated a worsening of symptoms versus an active treatment rilonacept baseline period."|Week 15 through Week 24 (randomized withdrawal)|Subjects were re-randomized as part of the randomized withdrawal period (Part B). Subjects were not necessarily assigned the same treatment as in the first double-blind portion (Part A). Subjects were analyzed using last observation carried forward.||Units of a Scale||Standard Deviation|Mean
718648|NCT00288704|Primary|Change From Baseline to Week-6 (Part A) Endpoint in Mean Key Symptom Score (KSS)|"The mean Key Symptom Score (KSS --from the validated, patient-administered Daily Health Assessment Form(DHAF)) was the average on a 0-10 scale (0=None, 10=Very Severe) of 5 separate scales -- rash, feeling of fever/chills, joint pain, eye redness/pain, and fatigue). KSS was averaged over two 21-day daily reporting periods (the 3 weeks prior to both baseline and week 6). In part A, a negative change in mean values indicated improvement under treatment with rilonacept in symptoms.
The DHAF was used because it is a validated instrument to collect subject's self-reported responses."|Baseline (Days -21 to -1) and Week 6 (Days 21-42)|Cryopyrin Associated Autoinflammatory Syndrome (CAPS) is a rare, orphan, hereditary disease. There are several hundred CAPS cases in the United States.||Units of a Scale||Standard Deviation|Mean
718649|NCT00288860|Primary|Rehospitalization|Number of patients with psychiatric hospitalization within 12 months of discharge from PTSD program|12 months post discharge|||participants|||Number
718650|NCT00288860|Secondary|Depressive Symptoms, Subjective Quality of Life|Depression: Center for Epidemiological Studies Scale (ranges from 0 to 60, with higher scores indicating worse depression) Quality of Life: Scale from the Veterans Affairs Military Stress Treatment Assessment (scores range from 1 to 7, with higher scores indicating better quality of life)|12 months post-discharge (8 months post intervention)|||units on a scale||Standard Deviation|Mean
718651|NCT00288860|Primary|Aggressive Behavior; Alcohol Misuse; Drug Misuse; PTSD Symptoms|"Higher scores are worse outcomes on all four measures:
Aggressive behavior (scale from 0-6 types of violent behavior than past four months) - adapted from conflict tactics scale Alcohol problems: Addiction Severity Index Alcohol composite (ranges from 0 to 1) Drug problems: Addiction Severity Index Drug composite (ranges from 0 to 1) PTSD symptoms: DSM IV PTSD Checklist (ranges from 17 to 85)"|12 months post-discharge (8 months post intervention)|||Scores on a scale||Standard Deviation|Mean
718652|NCT00288886|Secondary|Rates of Hospitalization (Across the Prior 90 Days)|Number of days hospitalized for any reason per the previous 90 days|Assessed at Baseline, 3-, 6-, and 12-months|||days||Standard Deviation|Mean
718653|NCT00288886|Secondary|Days of Substance Abuse (Across the Prior 90 Days)||Assessed at Baseline, 3-, 6-, and 12-month follow-up|||percentage of 90 days||Standard Deviation|Mean
718654|NCT00288886|Secondary|Self-help Support Group Attendance||Assessed over the past 90 days at 3, 6 and 12 months, and cumulative over 1 year|||days||Standard Deviation|Mean
718655|NCT00288886|Secondary|Aftercare Attendance|Measures of aftercare attendance include: Percentage of participants who attended at least 1 aftercare session; percentage of participants who attended at least 2 aftercare sessions/month for at least 3, 6, 9 and 12 months; and percentage of participants who passed the VAMC's SUD continuity of care performance measure (a benchmark for retention of clients in aftercare for at least two visits each month for 3 months following initial treatment)|Assessed at 3-, 6-, 9-, and 12-months|||percentage of participants|||Number
718656|NCT00288886|Secondary|Days Until First Use of Alcohol or Drugs||Baseline to 12 months|||days||Standard Deviation|Mean
718657|NCT00288886|Secondary|Abstinence Rate (During the Preceding 90 Days) at 3- and 6-months Follow-up Point as Assessed by the Form-90|Participants who were abstinent was assessed via Form-90 Interview (Form 90I) is a structured interview that assesses substance use and related behaviors over the previous 90 days employing a calendar-based follow-back method that provides continuous measures of substance use, and has good reliability. Measures include days abstinent, days using alcohol, days using drugs, total number of standard drinks, and days of self help meeting attendance. Briefer versions were constructed to collect data via telephone in instances when participants did not return for in-person interviews. As a reliability check on participants' self-report, a collateral interview was employed when contacting informants. Participants who denied use on the Form-90, but had a positive substance use screen were considered to be not abstinent for that follow-up point.|Assessed at 3 and 6 months|||participants|||Number
718658|NCT00288886|Primary|Abstinence Rate (During the Preceding 90 Days) at 12 Months Follow-up Point as Assessed by the Form-90|Participants who were abstinent was assessed via Form-90 Interview (Form 90I) is a structured interview that assesses substance use and related behaviors over the previous 90 days employing a calendar-based follow-back method that provides continuous measures of substance use, and has good reliability. Measures include days abstinent, days using alcohol, days using drugs, total number of standard drinks, and days of self help meeting attendance. Briefer versions were constructed to collect data via telephone in instances when participants did not return for in-person interviews. As a reliability check on participants' self-report, a collateral interview was employed when contacting informants. Participants who denied use on the Form-90, but had a positive substance use screen were considered to be not abstinent for that follow-up point.|Assessed at 12 months|||participants|||Number
718659|NCT00288912|Secondary|Arthritis Self Efficacy|The Arthritis Self-Efficacy Scale measures how certain patients are they can perform 8 specific activities or tasks, related to arthritis. Items are scored on a Likert Scale (1=very uncertain to 10=very certain), with total scores ranging from 1-10. Higher scores indicate greater arthritis self-efficacy.|Baseline and 12 months|||units on a scale||Standard Deviation|Mean
718660|NCT00288912|Secondary|AIMS 2 Affect|The AIMS2 affect subscale includes ten items that encompass mood and tension. All items on the AIMS2 affect subscale are measured on a 5-point Likert scale (“all days” to “no days”). Scores can range from 0-10, with higher scores indicating worse affect.|Baseline and 12 months|||units on a scale||Standard Deviation|Mean
719311|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and TG|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks|||Correlation coefficient|||Number
718662|NCT00288912|Primary|Pain|Arthritis Impact Measurement Scales-2 (AIMS2), which consists of five items assessing typical pain, pain severity, and pain during specific times of the day, using a 5-point Likert scale (“all days” to “no days”). The possible range of scores is 0-10, with higher scores indicating more severe pain.|Baseline and 12-month follow-up|||units on a scale||Standard Deviation|Mean
718663|NCT00289016|Secondary|Number of Participants With Adverse Events|"The severity of an adverse event (AE) was graded according to Common Toxicity Criteria for Adverse Events (CTCAE) Version 3 (1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death).
Serious adverse events include death, life-threatening events, events requiring or prolonging hospitalization, result in persistent or significant disability/incapacity, or a congenital anomaly/birth defect, or otherwise important medical events that may jeopardise the patient or require intervention to prevent one of the above outcomes."|From first dose of talimogene laherparepvec until 30 days after the last dose; the median (minimum, maximum) duration of treatment was 82 (1, 346) days.|ITT population||participants|||Number
718664|NCT00289016|Secondary|Duration of Response|Duration of response was calculated from the initial date of response (CR or PR) until the date of progressive disease (or until last follow up that was CR or PR). Participants could have multiple response periods; in this situation, the last response interval was used for the calculation of duration of response.|From enrollment until the data cut-off date of 29 November 2008; Median duration of follow-up was 253 days.|ITT population with an objective response (PR or CR)||days||Full Range|Median
718665|NCT00289016|Secondary|Time to Longest Continuous Response|Time to response was calculated from the date of the first talimogene laherparepvec dose to the initial date of the participant’s last response interval.|From enrollment until the data cut-off date of 29 November 2008; Median duration of follow-up was 253 days.|ITT population with an objective response (PR or CR)||days||Full Range|Median
718666|NCT00289016|Secondary|Time to Progression|"Time to progression was calculated from the date of the first talimogene laherparepvec dose to the first date of documented progressive disease (via clinical symptom or tumor burden assessment) that was not followed by a later response of CR, PR, or stable disease.
Median time to progression was calculated using the Kaplan-Meier method."|From enrollment until the data cut-off date of 29 November 2008; Median duration of follow-up was 253 days.|ITT population||days||Full Range|Median
718667|NCT00289016|Secondary|Overall Survival|Overall survival (OS) was calculated from the date of the first talimogene laherparepvec dose to the date of death. Median OS was estimated using the Kaplan-Meier method.|From enrollment until the data cut-off date of 29 November 2008; Median duration of follow-up was 253 days|ITT population||days||Full Range|Median
718668|NCT00289016|Primary|Objective Tumor Response Rate|"Objective response rate is defined as the percentage of participants with an overall best response of complete response or partial response. The objective response to treatment was assessed by computed tomography (CT) scanning or other clinical measurement using modified Response Evaluation Criteria In Solid Tumors (RECIST). Responses must have been confirmed on two visits not less than 4 weeks apart.
Tumor burden for a visit was calculated as the sum of the longest diameters of all tumors identified and measured up to that visit. Tumor response at each visit was derived from tumor burden, as follows:
Complete response (CR): zero tumor burden
Partial response (PR): a 30% or greater decrease in tumor burden
Progressive disease (PD): a 20% or greater increase in tumor burden
Stable disease (SD): none of the above (a < 30% decrease and < 20% increase in tumor burden)"|From enrollment until the data cut-off date of 29 November 2008; Median duration of follow-up was 253 days|Intent-to-treat (ITT) population (all participants who received at least 1 dose of talimogene laherparepvec)||percentage of participants|||Number
718669|NCT00289094|Secondary|SF-12 Patient Outcomes||Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.||||||
718670|NCT00289094|Secondary|Medical Imaging||Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.||||||
718671|NCT00289094|Secondary|Complications/Revisions||On-going to end of study.||||||
718672|NCT00289094|Primary|Knee Society Scores|The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. For each section, a score of 80-100 = excellent, 70-79 = good; 60-69 = fair; and < 60 = poor.|Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.|||Scores on a scale||Standard Deviation|Mean
718673|NCT00289107|Secondary|SF-12 Patient Outcomes||Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.||||||
718674|NCT00289107|Secondary|Medical Imaging||Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.||||||
718675|NCT00289107|Secondary|Revisions||On-going to end of study||||||
718676|NCT00289107|Secondary|Complications||On-going to end of study||||||
718677|NCT00289107|Primary|Knee Society Score|The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. For each section, a score of 80-100 = excellent, 70-79 = good; 60-69 = fair; and < 60 = poor.|Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.|||Scores on a scale||Standard Deviation|Mean
718678|NCT00289120|Primary|The Plasma and Urine Parameters|"The Urine Parameters that were assessed at the end of cola and water (arms) phase:
Urine Parameters:
uNa (mEq per d) uK (mEq per d)
The parameters were consolidated into the one value as a mean of all the values in the phase or group (Table 3) and later for longitudinal analysis as a mean of all the values in the phase for each participant (Table 4).
measure of dispersion was standard deviation."|at the end of 6-day intervention of Cola and water phase|||mEq per d||Standard Deviation|Mean
718679|NCT00289120|Secondary|Urinary pH|"The Urine pH that were assessed at the end of cola and water (arms) phase The parameters were consolidated into the one value as a mean of all the values in the phase or group (Table 3) and later for longitudinal analysis as a mean of all the values in the phase for each participant (Table 4).
measure of dispersion was standard deviation."|at the end of each 6-day intervention in Cola and Water Phase|||pH||Standard Deviation|Mean
718680|NCT00289120|Secondary|Total Urine Volume|"The Plasma and Urine Parameters that were assessed at the end of cola and water (arms) phase:
Urine Parameters:
Total Urine Volume (mL/day)
The parameters were consolidated into the one value as a mean of all the values in the phase or group (Table 3) and later for longitudinal analysis as a mean of all the values in the phase for each participant (Table 4).
measure of dispersion was standard deviation."|at the end of each 6-day intervention in Cola and Water Phase|||mL/day||Standard Deviation|Mean
718681|NCT00289120|Primary|The Plasma Osmolarity|"The Plasma osmolarity that were assessed at the end of cola and water (arms) phase:
Plasma Parameters:
OSM (mOsm/L)
The parameters were consolidated into the one value as a mean of all the values in the phase or group (Table 3) and later for longitudinal analysis as a mean of all the values in the phase for each participant (Table 4).
measure of dispersion was standard deviation."|at the end of 6-day intervention of cola and water phase|||mOsm/L||Standard Deviation|Mean
718682|NCT00289120|Primary|The Plasma and Urine Parameters|"The Plasma and Urine Parameters that were assessed at the end of cola and water (arms) phase:
Plasma Parameters:
Na (mEq per L) K (mEq per L) CL (mEq per L) CO2(mEq per L) AG (mEq per L)
The parameters were consolidated into the one value as a mean of all the values in the phase or group (Table 3) and later for longitudinal analysis as a mean of all the values in the phase for each participant (Table 4).
measure of dispersion was standard deviation."|at the end of 6-day intervention of Cola and water phase|||mEq/L||Standard Deviation|Mean
718683|NCT00289120|Primary|The Plasma and Urine Parameters|"The Plasma and Urine Parameters that were assessed at the end of cola and water (arms) phase:
Plasma Parameters:
CA (mg per dL) GLU (mg per dL) BUN (mg per dL) Cr (mg per dL) Prot (mg per dL) ALB (mg per dL)
Urine Parameters:
uCa (mg per dL) uMg (mg per dL) uP (mg per dL) uCr (mg per dL) uCit (mg per dL) uOx (mg per dL) uUA (mg per dL)
The parameters were consolidated into the one value as a mean of all the values in the phase or group (Table 3) and later for longitudinal analysis as a mean of all the values in the phase for each participant (Table 4).
measure of dispersion was standard deviation."|at the end of each 6-day intervention in Cola and Water Phase|||mg per dL||Standard Deviation|Mean
718684|NCT00289133|Secondary|Radiographic Outcomes - Percentage of Knees With Tibial Osteolysis (>2mm)||Minimum 5 years, up to 7.6 years|The number of knees in which radiographs were analyzed was the number available for analysis at this post-operative timepoint.||percentage of knees|Knees||Number
718685|NCT00289133|Secondary|Radiographic Outcomes - Percentage of Knees With Femoral Osteolysis (>2mm)||Minimum 5 years, up to 7.6 years|The number of knees in which radiographs were analyzed was the number available for analysis at this post-operative timepoint.||percentage of knees|Knees||Number
718686|NCT00289133|Secondary|Radiographic Outcomes - Percentage of Knees With Tibial Radiolucencies (>2mm)||Minimum 5 years, up to 7.6 years|The number of knees in which the radiographs were analyzed was the number available for analysis at this post-operative timepoint.||percentage of knees|Knees||Number
718687|NCT00289133|Secondary|Radiographic Outcomes - Percentage of Knees With Femoral Radiolucencies (>2mm)||Minimum 5 years, up to 7.6 years|The number of knees analyzed was the number available for analysis at this post-operative timepoint.||percentage of knees|Knees||Number
718688|NCT00289133|Secondary|Western Ontario and McMaster Universities Arthritis Index (WOMAC) Osteoarthritis Total Score|WOMAC is a patient reported outcome (PRO) that evaluates the condition of subjects with knee osteoarthritis, and includes pain (score range 0-20), stiffness (score range 0-8), and physical function (score range 0-68) of the joint. The total score ranged from 0 to 96. The subscales are combined (summed) to compute a total score, where a lower score indicates a better outcome.|Minimum 5 years, up to 7.6 years|The number of knees analyzed was the number available for analysis at this post-operative timepoint.||scores (points) on a scale|Knees|Standard Deviation|Mean
718689|NCT00289133|Secondary|Western Ontario and McMaster Universities Arthritis Index (WOMAC) Osteoarthritis Total Score|WOMAC is a patient reported outcome (PRO) that evaluates the condition of subjects with knee osteoarthritis, and includes pain (score range 0-20), stiffness (score range 0-8), and physical function (score range 0-68) of the joint. The total score ranged from 0 to 96. The subscales are combined (summed) to compute a total score, where a lower score indicates a better outcome.|2 year|The number of knees analyzed was the number available for analysis at this post-operative timepoint.||scores (points) on a scale|Knees|Standard Deviation|Mean
718690|NCT00289133|Secondary|American Knee Society Evaluation - Total Score|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|Minimum 5 years, up to 7.6 years|The number of knees analyzed was the number available for analysis at this post-operative timepoint.||scores on a scale|Knees|Standard Deviation|Mean
718691|NCT00289133|Secondary|American Knee Society Evaluation - Total Score|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|2 year|The number of knees analyzed was the number available for analysis at this post-operative timepoint.||scores on a scale|Knees|Standard Deviation|Mean
718692|NCT00289133|Primary|Survivorship (Revision of Any Component for Any Reason)|Survival was estimated by Kaplan-Meier method. Kaplan Meier survivorship analysis estimates the proportion of a population that will survive past a certain time avoiding a certain event. In this study, the event is removal of any component for any reason, also known as revision for any reason. Survival estimates are provided when 40 devices are left still being followed.|5 years|Survivorship can only be calculated on knees (not participants as some study subjects had bilateral knees in the study) with post-operative follow-up. 35 knees were excluded due to post-operative follow-up not being available. 67 knees were excluded due to protocol violations.||percentage of knees|number of knees|95% Confidence Interval|Number
718693|NCT00289185|Secondary|Plasmodium Falciparum (P. Falciparum) Parasite Density in Subjects Prevalent for Parasitemia|The parasite density in subjects prevalent for P. falciparum parasitemia (Subjects with the presence of P. falciparum asexual parasitemia above 0 per microliter (µL) on Giemsa stained thick blood films), was detected at a cross sectional time point 7 months after administration of Dose 3 of RTS,S or HBV vaccine (Month 9). Parasite density is expressed as mean, minimum and maximum density in parasite per µL. This outcome for solely assessed in the Engerix-B Group, as no subject in the RTS,S/AS02D was assessed as prevalent for parasitemia.|At Month 9|The analysis was performed on the According-to-Protocol cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome variables were available.||Parasite per microliter (µL)||Full Range|Mean
718694|NCT00289185|Secondary|Number of Subjects Prevalent for Parasitemia|Subjects prevalent for P. falciparum parasitemia were defined as subjects with the presence of P. falciparum asexual parasitemia above 0 per microliter (µL) on Giemsa stained thick blood films.|At Month 9|The analysis was performed on the According-to-Protocol cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome variables were available.||Subjects|||Number
718695|NCT00289185|Secondary|Time to First Malaria Infection|Malaria infection by Plasmodium falciparum (P. falciparum) was detected by active detection of infection (ADI) and passive case detection (PCD), and was defined as the presence of P. falciparum asexual parasitemia above 0 per microliter (µL) on Giemsa stained thick blood films. The time to first malaria infection is expressed in terms of rate of first malaria infection, that is, the number of malaria infection events reported (n) over the period elapsed until the event occurred (i.e. events per Persons Year at Risk [PYAR]) for each group.|Over the period starting 14 days after Dose 3 of RTS,S or HBV vaccine and extending for 6 months thereafter (from Month 2.5 up to Month 9).|The analysis was performed on the According-to-Protocol cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome variables were available.||n/PYAR|||Number
718696|NCT00289185|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Throughout the entire study, from Week 0 to Month 20.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subjects|||Number
718697|NCT00289185|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs).|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within 30 days (Days 0–29) after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subjects|||Number
718698|NCT00289185|Secondary|Number of Subjects With Solicited General Symptoms.|Assessed solicited general symptoms were drowsiness, fever, irritability, and loss of appetite. Fever was defined as axillary temperature above or equal to (>=) 37.5 degrees Celsius (°C).|Within 7 days (Days 0-6) after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subject|||Number
718699|NCT00289185|Secondary|Number of Subjects With Solicited Local Symptoms.|Assessed solicited local symptoms were pain and swelling following vaccination with the TETRActHib vaccine..|Within 7 days (Days 0-6) after vaccination with the TETRActHib vaccine.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subject|||Number
718700|NCT00289185|Secondary|Number of Subjects With Solicited Local Symptoms.|Assessed solicited local symptoms were pain and swelling following vaccination with the RTS,S/AS02D or Engerix-B vaccine.|Within 7 days (Days 0-6) after vaccination with the RTS,S/AS02D or Engerix-B vaccine.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subject|||Number
718701|NCT00289185|Secondary|Concentrations of Anti-Circumsporozoite Protein (Anti-CS) Antibodies|Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations are expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EL.U/mL). The cut-off of the assay was the seropositivity cut-off value of 0.5 EL.U/mL.|Prior to vaccination at Week 0 (PRE), at Month 2, at Month 3 and at Month 9.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.||ELISA unit per milliliter||95% Confidence Interval|Geometric Mean
718702|NCT00289185|Primary|Number of Subjects With Anti-Bordetella Pertussis Toxin Antibody (Anti-BPT) Concentrations Equal to or Above (>=) the Seropositivity Cut-off Value|Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). The seropositivity cut-off value was 15 ELISA units per milliliter (EL.U/mL). Blood samples were collected prior to vaccination at Week 0 (PRE), and at Month 3. Month 3 results are the specific results for this primary outcome measure.|Prior to vaccination at Week 0 (PRE), and at Month 3.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.||Subjects|||Number
718703|NCT00289185|Primary|Number of Subjects With Anti-polyribosyl Ribitol Phosphate Antibody (Anti-PRP) Concentrations Equal to or Above (>=) the Seroprotection Cut-off Value|Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). The seroprotection cut-off value was 0.15 microgram per milliliter (µg/mL). Blood samples were collected prior to vaccination at Week 0 (PRE), and at Month 3. Month 3 results are the specific results for this primary outcome measure.|Prior to vaccination at Week 0 (PRE), and at Month 3.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.||Subjects|||Number
718704|NCT00289185|Primary|Number of Subjects With Anti-tetanus Antibody (Anti-T) Concentrations Equal to or Above (>=) the Seroprotection Cut-off Value|Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). The seroprotection cut-off value was 0.1 international unit per milliliter (IU/mL). Blood samples were collected prior to vaccination at Week 0 (PRE), and at Month 3. Month 3 results are the specific results for this primary outcome measure.|Prior to vaccination at Week 0 (PRE), and at Month 3.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.||Subject|||Number
718716|NCT00289211|Secondary|Antigenic C1 Inhibitor (C1INH) Serum Levels|Change in antigenic C1INH serum levels from pre-infusion to 1-, 2-, 4-, and 12 hours after the initial dose of blinded study drug.|Pre-infusion to 1-, 2-, 4-, and 12 hours post-infusion|ITT-E subjects (N=68) with data available.||mg/dL||Standard Deviation|Mean
718705|NCT00289185|Primary|Number of Subjects With Anti-diphtheria Antibody (Anti-D) Concentrations Equal to or Above (>=) the Seroprotection Cut-off Value|Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). The seroprotection cut-off value was 0.1 international unit per milliliter (IU/mL). Blood samples were collected prior to vaccination at Week 0 (PRE), and at Month 3. Month 3 results are the specific results for this primary outcome measure.|Prior to vaccination at Week 0 (PRE), and at Month 3.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.||Subject|||Number
718706|NCT00289185|Primary|Number of Subjects With Hepatitis B Antibody (Anti-HB) Concentrations Equal to or Above (>=) the Seroprotection Cut-off Value|The seroprotection cut-off value was 10 milli-international units per milliliter (mIU/mL). Blood samples were collected prior to vaccination at Week 0 (PRE), at Month 2 and at Month 3. Month 3 results are the specific results for this primary outcome measure.|Prior to vaccination at Week 0 (PRE), at Month 2 and at Month 3.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.||Subject|||Number
718707|NCT00289185|Primary|Concentrations of Anti-Bordetella Pertussis Toxin Antibodies (Anti-BPT).|Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EL.U/mL). The cut-off of the assay was the seropositivity cut-off of 15 EL.U/mL. Month 3 results are the specific results for this primary outcome measure.|Prior to vaccination at Week 0 (PRE), and at Month 3.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.||ELISA unit per millilite||95% Confidence Interval|Geometric Mean
718708|NCT00289185|Primary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Month 9 to Month 20.|||Subject|||Number
718709|NCT00289185|Primary|Concentrations of Anti-polyribosyl Ribitol Phosphate Antibodies (Anti-PRP).|Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per milliliter (µg/mL). The cut-off of the assay is the seroprotection cut-off value of 0.15 µg/mL. Month 3 results are the specific results for this primary outcome measure.|Prior to vaccination at Week 0 (PRE), and at Month 3.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.||international unit per milliliter||95% Confidence Interval|Geometric Mean
718710|NCT00289185|Primary|Concentrations of Antibodies Against Tetanus (Anti-T)|Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in international unit per milliliter (IU/mL). The cut-off of the assay was the seroprotection cut-off of 0.1 IU/mL. Month 3 results are the specific results for this primary outcome measure.|Prior to vaccination at Week 0 (PRE), and at Month 3.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.||international unit per milliliter||95% Confidence Interval|Geometric Mean
718711|NCT00289185|Primary|Concentrations of Antibodies Against Diphtheria (Anti-D)|Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in international unit per milliliter (IU/mL). The cut-off of the assay was the seroprotection cut-off of 0.1 IU/mL. Month 3 results are the specific results for this primary outcome measure.|Prior to vaccination at Week 0 (PRE), and at Month 3.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.||international unit per milliliter||95% Confidence Interval|Geometric Mean
718712|NCT00289185|Primary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Week 0 to Month 9.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subject|||Number
718713|NCT00289185|Primary|Concentrations of Antibodies Against Hepatitis B (Anti-HB)|Concentrations were expressed as geometric mean concentrations (GMCs) in milli-international unit per milliliter (mIU/mL). The cut-off of the assay was the seroprotection cut-off of 10 mIU/mL. Month 3 results are the specific results for this primary outcome measure.|Prior to vaccination at Week 0 (PRE), at Month 2 and at Month 3.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.||milli-international unit per milliliter||95% Confidence Interval|Geometric Mean
718714|NCT00289211|Secondary|Complement C4 Serum Levels|Change in complement C4 serum levels from pre-infusion to 1-, 2-, 4-, and 12 hours after the initial dose of blinded study drug.|Pre-infusion to 1-, 2-, 4-, and 12 hours post-infusion|ITT-E subjects (N=68) with data available.||mg/dL||Standard Deviation|Mean
718715|NCT00289211|Secondary|Functional C1INH Serum Levels|"Percent change in functional C1INH serum levels from pre-infusion to 1-, 2-, 4-, and 12 hours after the initial dose of blinded study drug.
Functional C1INH serum levels are expressed as a percent of total detectable C1INH (ie, functional C1INH/total detectable C1INH)."|Pre-infusion to 1-, 2-, 4-, and 12 hours post-infusion|ITT-E subjects (N=68) with data available.||percent of functional C1INH||Standard Deviation|Mean
718718|NCT00289211|Secondary|Number of Subjects With Beginning of Substantial Relief of the Defining Symptom|Randomized subjects assessed their symptoms every 15 minutes up to 4 hours after the initial dose of blinded study drug or until substantial relief of the defining symptom was achieved. Substantial relief was defined as 3 consecutive assessments of improvement of the defining symptom. Beginning of substantial relief was considered the first of the 3 consecutive assessments.|Within 4 hours after initial treatment|ITT-Efficacy (ITT-E) Population (N=68; 3 of the 71 randomized [ie, ITT] subjects were excluded from the ITT-E Population, as it was later determined that they did not experience a definitive hereditary angioedema [HAE] attack).||participants|||Number
718719|NCT00289211|Primary|Time to Beginning of Substantial Relief of the Defining Symptom|Randomized subjects assessed their symptoms every 15 minutes up to 4 hours after the initial dose of blinded study drug or until substantial relief of the defining symptom was achieved. Substantial relief was defined as 3 consecutive assessments of improvement of the defining symptom. Beginning of substantial relief was considered the first of the 3 consecutive assessments.|Within 4 hours after initial treatment|Intent-to-treat (ITT) Population (all randomized subjects). Since less than 50% of subjects in the placebo group achieved the endpoint, median time to event was not estimable (NE). Further, the number of censored events in the C1INH-nf and placebo groups precluded estimation of the 95% confidence interval (CI) upper bound for median time to event.||hours||95% Confidence Interval|Median
718720|NCT00289276|Secondary|Number of Adverse Events|All adverse events were collected for this trial such as (but not limited to): Atrial Fibrillation, Chest Pain, Pneumonia, Cold/Flu|From enrollment to study exit (up to 36 months).|Number of participants analyzed for this outcome is limited to subjects who experienced at least one Adverse Event from enrollment to study exit.||Adverse Events|||Number
718721|NCT00289276|Secondary|Change in Thoracic Impedance Associated With Heart Failure (HF) Outpatient Treatment of an Exacerbation of HF|Difference in mean thoracic impedance: post-outpatient visit minus pre-outpatient visit.|1 day pre and 1 day post-outpatient visit|All subjects with at least one heart failure outpatient treatment and with impedance data pre and post-outpatient treatment.||Ohms||Full Range|Mean
718722|NCT00289276|Secondary|Change in Thoracic Impedance Associated With Heart Failure (HF) Hospitalization for an Exacerbation of HF|Difference in mean thoracic impedance: post-hospitalization minus pre-hospitalization.|3 days pre-admission and 3 days post-discharge|All subjects with at least one heart failure hospitalization and with impedance data pre and post-hospitalization.||Ohms||Full Range|Mean
718723|NCT00289276|Primary|Number of Subjects With at Least 30 Days of Daily Impedance Measurements|Impedance measurements were presented graphically over time in relation to clinical events for all subjects with at least 30 days of follow-up and impedance data collected during the follow-up period.|Up to 36 months.|Includes all enrolled participants.||participants|||Number
718724|NCT00289289|Secondary|Atrial Tachycardia/Atrial Fibrillation (AT/AF) Burden|AT/AF burden is defined as the sum of the duration of all atrial arrhythmias as recorded by the device divided by the device follow-up time during the programming period expressed as hours of atrial arrhythmia per day.|6 months (per Intervention)|Of the 256 randomized to ON-OFF or OFF-ON programming, 225 had device data necessary for computing AT/AF burden in both randomized study periods.||hours per day||Standard Deviation|Mean
718725|NCT00289289|Secondary|Time to First Cardioversion (Changing an Abnormal Heart Rhythm Into a Normal One by Using Either Medication or Electrical Shock)|The dates of cardioversions attempted for atrial fibrillation (AF) since the previous study visit were collected at the 3, 9, and 15 month follow-up visits. For each randomized subject, the months to first attempted cardioversion during each randomized study period (3-9 months and 9-15 months) was determined. A repeated measures Cox proportional hazards model was used to compare the attempted cardioversion rate during periods of time where the pacing features were programmed ON versus OFF.|6 months (per Intervention)|All randomized subjects with follow-up during intervention pacing feature programming period.||Months||Standard Deviation|Mean
718726|NCT00289289|Secondary|Evaluate Subject Symptoms With the Atrial Fibrillation (AF) Symptom Checklist|The AF symptom checklist (SCL) is a 16 item questionnaire measuring the frequency of 16 arrhythmia related symptoms such as tiredness/lack of energy, heart fluttering/skipping, heart racing, lightheadedness, etc. Symptom frequency is rated as never (scored as 0), rarely (scored as 1), sometimes (scored as 2), often (scored as 3), and always (scored as 4). Scores are summed across each subject and timepoint and range from 0 (no symptoms) to 64 (always symptoms). For each subject the 9 month and 15 months scores were summed respectively and ON minus OFF differences computed.|6 months (per Intervention)|Of the 256 randomized subjects only 211 completed the AF symptom checklist at both the 9-month and 15-month visit. Since this was a crossover study, data from both visits was required for the subject to be included in the analysis||Scores on a scale||Full Range|Median
718727|NCT00289289|Primary|Rate of Symptomatic Atrial Tachycardia/Atrial Fibrillation Episodes Per Subject Per Month|The frequency of symptomatic atrial tachycardia/atrial fibrillation (AT/AF) episodes as measured by the Patient Assistant and retrieved from save-to-disk information. For each subject and programming period (3-9 month period and 9-15 month period), the rate of symptomatic AT/AF episodes was computed by summing the total number of Patient Assistant activations during device recorded AT/AF episodes divided by months of device follow-up in each study period. Within each subject, the ON minus OFF difference in rate of symptomatic AT/AF was computed|6-months (per Intervention)|Patient Assistant data which contained markers for symptomatic atrial tachycardia or atrial fibrillation episodes obtained from save-to-disk data was required from both randomized follow-up periods (3-9 months and 9-15 months) for the subject to be included in the primary ITT analysis.||Episodes per subject per month||Standard Deviation|Mean
718728|NCT00289341|Secondary|Change in PSA Slope, Pre- vs Post-vaccination.|To model the evolution of PSA (in log-scale) during the three study phases (pre-vaccine, vaccine, and post-vaccine phases), a mixed linear spline model was used. Two knots (one at the start of the vaccine phase and the other at the start of the post-vaccine phase) were used to directly quantify the differences in slopes between each phase. To account for the heterogeneous treatment effect and the repeated measures structure, random effects are incorporated into the model. For the general model, random effects for the intercept, slope and the first knot were considered.|pre- vs post- vaccination PSA slopes.|23 of 24 patients were analyzed. 1 patient was not evaluable.||log₂(ng/ml)/month||95% Confidence Interval|Number
719312|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 weeks|||Correlation coefficient|||Number
718729|NCT00289341|Primary|"Immunogenicity of the DC/LNCaP Vaccine. Pre- vs Post-vaccination Bulk T Cell Proliferation (3H Thymidine Incorporation) by Type of Antigen. The Number Indicated is the Median Difference of Post-Pre, of Each Antigen Group."|The difference between post minus pre-vaccination bulk T cell proliferation was calculated for each antigen.|pre- vs post-vaccination. Pre-vaccination T cells were collected at Wk 0 and post-vaccination T cells were collected at Wk 13|The Arm/Group Title is different for this outcome. In the 1st outcome analysis, AEs were being compared between placebo and tx groups. After the blinded phase, placebo pts crossover and we compare pre-vs post vaccination T cell proliferation in all pts. 22 of 24 pts'assays were analyzed. Two were excluded as they failed internal controls.||cells *10^3 per minute||95% Confidence Interval|Median
718730|NCT00289341|Primary|Adverse Event|Occurrence of adverse events (AE) was compared between the placebo and vaccine groups during the blinded phase (the 1st 9 weeks). At the end of this phase, all were unblinded, and those who received placebo crossed over to now receive vaccine. All serious AEs and any other AEs that occurred 5 times or more are reported. The exact binomial test was used to compare the occurrence of each AE between groups.|End of blinded phase (wk 9)|All AEs occurring 5 or more times during the study were analyzed. All AEs reported are grade 1 except as noted.||Adverse Events|||Number
718731|NCT00289458|Primary|Change in Dual Task Function|change in Timed Up and Go Cognitive Test (time in sec., lower number means better performance)|baseline and 11 weeks|||unit of scale (seconds)||Standard Deviation|Mean
718732|NCT00289458|Secondary|Change in Physical Activity|change in Physical Activity Scale for the Elderly (0 - up to 300, higher score more active)|baseline and 11 weeks|||unit of scale||Standard Deviation|Mean
718733|NCT00289458|Primary|Change in Falls-Efficacy|change in Activities Balance Confidence Scale (0 - 100, 100 represents high confidence, 0 represents low confidence)|baseline and 11 weeks|ITT and LOCF||unit of scale||Standard Deviation|Mean
718734|NCT00289458|Primary|Change in Walking|change in 6 minute walk (distance in meters covered in 6 minutes)over 11 weeks|baseline and 11 weeks|ITT and LOCF||unit of scale (meters per 6 minutes)||Standard Deviation|Mean
718735|NCT00289458|Primary|Change in Chair Stands|change in number of repetitions (the number of times moving from full sitting to full standing in 30 seconds)|baseline and 11 weeks|ITT and LOCF||number of stands per 30 seconds||Standard Deviation|Mean
718736|NCT00289458|Primary|Change in Balance|Berg Balance Scale range 0 - 36 (36 is excellent balance, 0 is poor or no ability for standing balance)|baseline and 11 weeks|ITT and LOCF||units on a scale||Standard Deviation|Mean
718737|NCT00289471|Primary|Performance Characteristics|Sensitivity and Specificity for Modified Mini-Mental Status Examination (MMSE), a measure scored 0-100 to assess cognitive impairment|Cross-sectional [at baseline; no longitudinal component]|||Percentage of participants||95% Confidence Interval|Number
718750|NCT00289718|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|An SAE is any untoward medical occurrence that: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above|During the follow-up period after additional vaccination (minimum 30 days)|Analysis was performed on the Long Term Total cohort, on subjects who received an additional vaccine dose.||subjects|||Number
718751|NCT00289718|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product|During the 30-day follow-up period after additional vaccination|Analysis was performed on the Long Term Total cohort, on subjects who received an additional vaccine dose.||subjects|||Number
718752|NCT00289718|Secondary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed include fatigue, fever, gastrointestinal symptoms, and headache|During the 4-day (Day 0-3) follow-up period after additional vaccination|Analysis was performed on the Long Term Total cohort, on subjects who received an additional vaccine dose.||subjects|||Number
718753|NCT00289718|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling.|During the 4-day (Day 0-3) follow-up period after additional vaccination|Analysis was performed on the Long Term Total cohort, on subjects who received an additional vaccine dose.||subjects|||Number
718754|NCT00289718|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE) Assessed by the Investigators as Related to Vaccination or to Study Procedures or Lack of Efficacy|An SAE is any untoward medical occurrence that: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above|Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination|||subjects|||Number
718755|NCT00289718|Secondary|Anti-Hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration|"If a subject became seronegative (< 10 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose.
Only 1 subject was offered an additional dose and therefore the values obtained for this subject have been provided. Because only 1 subject was included it was not possible to provide a mean/median and a measure of dispersion."|Before the additional dose and 1 month after the additional dose|Analysis was performed on the Long Term Total cohort, on subjects who received an additional vaccine dose. Only 1 subject received an additional dose.||mIU/mL|||Number
718756|NCT00289718|Secondary|Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration|"Concentrations given as GMC expressed as mIU/mL.
If a subject became seronegative (< 15 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose."|Before the additional dose and 1 month after the additional dose||||||
718757|NCT00289718|Primary|Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration|Concentrations given as GMC expressed as mIU/mL.|Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination|Analysis was performed on the Long Term According-to-Protocol (LT-ATP) cohort for immunogenicity, on subjects with available data for the defined timepoint||mIU/mL||95% Confidence Interval|Geometric Mean
718758|NCT00289718|Primary|Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration|Concentrations given as geometric mean concentration (GMC) expressed as milli-international unit per millilitre (mIU/mL).|Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination|Analysis was performed on the Long Term According-to-Protocol (LT-ATP) cohort for immunogenicity, on subjects with available data for the defined timepoint||mIU/mL||95% Confidence Interval|Geometric Mean
718759|NCT00289744|Primary|Number of Subjects Reporting Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the 30-day follow-up period after additional dose|The analysis was performed on the total vaccinated cohort for the additional dose.||subjects|||Number
718760|NCT00289744|Primary|Number of Subjects Reporting Unsolicited Adverse Events|Unsolicited adverse event (AE) covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 30-day follow-up period after additional dose|The analysis was performed on the total vaccinated cohort for the additional dose.||subjects|||Number
718761|NCT00289744|Primary|Number of Subjects Reporting Solicited Local and General Symptoms|Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include fatigue, fever, gatrointestinal symptoms and headache.|During the 4-day follow-up period after additional dose|The analysis was performed on the total vaccinated cohort for the additional dose.||subjects|||Number
718762|NCT00289744|Primary|Number of Subjects Reporting Serious Adverse Events (SAEs) Assessed by the Investigator as Causally Related to Primary Vaccination, Study Procedures or Lack of Vaccine Efficacy|Serious adverse events (SAEs) assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|At Year 6, 7, 8, 9 and 10|The analysis was performed on the long-term (LT) total vaccinated cohort.||subjects|||Number
719077|NCT00279201|Secondary|INITIATION: Change From Baseline to Endpoint in 1,5 Anhydroglucitol (1,5 AG)||Baseline (Initiation), Endpoint (Week 24)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.||micrograms per milliliter (ug/mL)||Standard Deviation|Mean
718763|NCT00289744|Primary|Number of Subjects With Immune Response to the Additional Dose of Engerix™-B|"Immune response was defined as:
anti-hepatitis B surface antigen (anti-HBs) antibody concentration equal or above to 10 milli-international units per milliliter (mIU/mL) at 1 month post-challenge dose in subjects seronegative at the pre-challenge time-points
at least a 4-fold increase in anti-HBs antibody concentrations at 1 month post-challenge dose in subjects seropositive at the pre-challenge time-points."|One month after the additional dose administration|The analysis was performed on the total vaccinated cohort for the additional dose.||subjects|||Number
718764|NCT00289744|Primary|Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration||Before and 1 month after the additional dose administration|The analysis was performed on the total vaccinated cohort for the additional dose.||milli-international units per milliliter||95% Confidence Interval|Geometric Mean
718765|NCT00289744|Primary|Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration||At Year 6, 7, 8, 9 and 10|The analysis was performed on the total vaccinated cohort for the additional dose.||milli-international units per milliliter||95% Confidence Interval|Geometric Mean
718766|NCT00289744|Primary|Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration||Years 6, 7, 8, 9, and 10.|The analysis was performed on the total vaccinated cohort for the additional dose.||milli-international units per milliliter||95% Confidence Interval|Geometric Mean
718767|NCT00289757|Primary|Number of Seropositive Subjects for Anti-HAV Antibodies.|"Seropositivity for anti-HAV antibodies defined as antibody concentrations ≥ 15 mIU/mL for Year 11 to Year 20 time points.
The laboratory assay was changed at Year 11, thus the blood samples were with both the old and the new assay for the sake of bridging."|From Year 11 to Year 20|Analysis was performed on the Long Term According-to-Protocol (LT-ATP) cohort for immunogenicity, on subjects with available data for the defined timepoint.||Subjects|||Number
718768|NCT00289757|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|An SAE is any untoward medical occurrence that: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|During the follow-up period after additional vaccination up to Year 20|Analysis was performed on the Long Term Total cohort, only on subjects who received an additional vaccine dose during the current long-term follow-up study. If a subject became seronegative (< 15 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose.||Subjects|||Number
718769|NCT00289757|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AE)|"An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Grade AE = produced significant impairment of functioning or incapacitation and was a definite hazard to the subject's health.
Related AE = assessed by the investigator as related to the study vaccination."|During the 30-day follow-up period after additional vaccination (for subjects who received the additional vaccine dose between Year 11 and 15)|Analysis was performed on the Long Term Total cohort, only on subjects who received an additional vaccine dose during the current long-term follow-up study. If a subject became seronegative (< 15 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose.||Subjects|||Number
718770|NCT00289757|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms assessed included fatigue, fever, gastrointestinal symptoms, and headache.|During the 4-day (Day 0-3) follow-up period after additional vaccination|Analysis was performed on the Long Term Total cohort, only on subjects who received an additional vaccine dose during the current long-term follow-up study. If a subject became seronegative (< 15 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose.||Subjects|||Number
718771|NCT00289757|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms|"Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain = symptom that prevented normal activities. Grade 3 redness and swelling = redness or swelling above 30 mm and persisting more than 24 hours.
Any = incidence of a particular symptom regardless of intensity."|During the 4-day (Day 0-3) follow-up period after additional vaccination|Analysis was performed on the Long Term Total cohort, only on subjects who received an additional vaccine dose during the current long-term follow-up study. If a subject became seronegative (< 15 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose.||Subjects|||Number
718772|NCT00289757|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE) Assessed by the Investigators as Related to Vaccination or to Study Procedures or Lack of Efficacy|An SAE is any untoward medical occurrence that: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above|Years 11, 12, 13, 14, 15, 16, 17, 18, 19 and 20 after the first vaccine dose of the 2-dose primary vaccination|Analysis was performed on the Long Term Total cohort which included all subjects who returned to the follow-up study and who had received at least 1 dose of the vaccine in the primary study.||Subjects|||Number
718773|NCT00289757|Primary|Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration|Concentrations given as GMC expressed as mIU/mL.|Before the additional dose, 14 days and 30 days after the additional dose|Analysis was performed on the Long Term Total cohort, only on subjects who received an additional vaccine dose during the current long-term follow-up study. If a subject became seronegative (< 15 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose.||mIU/mL|||Number
718774|NCT00289757|Primary|Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration|"Concentrations given as geometric mean concentration (GMC) expressed as milli-international unit per millilitre (mIU/mL).
The laboratory assay was changed at Year 11, thus the blood samples were with both the old and the new assay for the sake of bridging."|At Years 11, 12, 13, 14, 15, 16, 17, 18, 19 and 20 after the first vaccine dose of the 2-dose primary vaccination|Analysis was performed on the Long Term According-to-Protocol (LT-ATP) cohort for immunogenicity, on subjects with available data for the defined timepoint.||mIU/mL||95% Confidence Interval|Geometric Mean
718992|NCT00278915|Secondary|Change in Breast Tanner Stage From Baseline to Month 12.|Change in breast Tanner stage from baseline to Month 12/last visit. Tanner stage (breast) is a score of range 1-5 where 1=no development and 5=adult breast|6 month pre-treatment observation period (result at Month 0 considered as baseline) followed by 12 month treatment period (on treatment period).|||units on a scale||Full Range|Median
718775|NCT00289770|Primary|Number of Subjects With Serious Adverse Events (SAEs) Determined by the Investigator to Have a Causal Relationship to Primary Vaccination or Due to Lack of Vaccine Efficacy|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|up to Year 11, 12, 13, 14, 15|Analysis was performed on the long-term (LT) Total Vaccinated Cohort, this included all subjects who had received at least one dose of the study vaccine in the primary study and who returned for the blood sampling time-point and who had serology results for anti-HAV and anti-HBs available.||subjects|||Number
718776|NCT00289770|Primary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject|During the 30-day follow-up period after additional Engerix vaccination|Analysis was performed on the long-term (LT) Total Vaccinated Cohort in subjects who were eligible for an additional dose. This included all subjects who had received at least one dose of the study vaccine in the primary study and who returned for the blood sampling timepoint and who had serology results for anti-HAV and anti-HBs available.||subjects|||Number
718777|NCT00289770|Primary|Number of Subjects With Unsolicited Symptoms|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 30-day follow-up period after additional Engerix vaccination|Analysis was performed on the long-term (LT) Total Vaccinated Cohort in subjects who were eligible for an additional dose. This included all subjects who had received at least one dose of the study vaccine in the primary study and who returned for the blood sampling timepoint and who had serology results for anti-HAV and anti-HBs available.||subjects|||Number
718778|NCT00289770|Primary|Number of Subjects With Solicited Local and General Symptoms Assessed|Solicited local symptoms were pain, redness and swelling. Solicited general symptoms were fatigue, fever, gastrointestinal, headache.|During the 4-day follow-up period after additional vaccination with Engerix|Analysis was performed on the long-term (LT) Total Vaccinated Cohort in subjects who were eligible for an additional dose. This included all subjects who had received at least one dose of the study vaccine in the primary study and who returned for the blood sampling timepoint and who had serology results for anti-HAV and anti-HBs available.||subjects|||Number
718779|NCT00289770|Primary|Number of Subjects, Receiving an Additional Vaccination of Engerix, With an Anamnestic Response|"Anamnestic response was assessed in subjects receiving an additional vaccine dose of Engerix. Two subjects were found eligible at Year 11 for this additional vaccine dose.
Anamnestic response was defined as:
post-additional vaccination anti-HBs concentration >= 10 mIU/mL in subject seronegative before additional dose.
4-fold increase post-additional dose compared to pre-additional vaccine time point."|30 days post additional dose of Engerix|Analysis was performed on the long-term (LT) Total Vaccinated Cohort in subjects who were eligible for an additional dose. This included all subjects who had received at least one dose of the study vaccine in the primary study and who returned for the blood sampling timepoint and who had serology results for anti-HAV and anti-HBs available.||subjects|||Number
718780|NCT00289770|Primary|Anti-HBs Antibody Concentrations|"Subjects who lost seroprotective concentrations for anti-HBs (< 10 mIU/mL) at any of the LT follow-up timepoints received an additional dose of Engerix after year 15.
Two subjects were eligible for this after Year 11.
3.29 in the table means a concentration of < 3.3 mIU/mL.
As the concentration was calculated per subject no mean concentration was calculated and also no measure of dispersion."|at Year 11, pre-additional vaccine, after additional dose of Engerix|Analysis was performed on the long-term (LT) Total Vaccinated Cohort in subjects who were eligible for an additional dose. This included all subjects who had received at least one dose of the study vaccine in the primary study and who returned for the blood sampling timepoint and who had serology results for anti-HAV and anti-HBs available.||mIU/mL|||Number
718781|NCT00289770|Primary|Anti-HAV and Anti-HBs Antibody Concentrations|"Concentrations are expressed as geometric mean concentrations (GMCs) in mIU/mL.
The laboratory assay was changed from Year 13 to Year 14 to in-house ELISA and at Year 15 to CLIA for anti-HBs GMCs.Thus for the sake of bridging, blood samples corresponding to Year 14 previously tested with ELISA were re-tested with CLIA (Year 14*)."|Years 11, 12, 13, 14 and 15|Analysis was performed on the long-term (LT) According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who returned at a particular blood sampling timepoint, were in the ATP immunogenicity cohort in the primary study and for whom serology results were available for that particular timepoint.||mIU/mL||95% Confidence Interval|Geometric Mean
718782|NCT00289770|Primary|Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values|Cut-off values were defined 3.3 mIU/mL for the in-house anti-HBs assay and 6.2 mIU/mL for the ChemiLuminescence ImmunoAssay, which was also considered as seropositivity, and 10 mIU/mL.|Years 11, 12, 13, 14 and 15|Analysis was performed on the long-term (LT) According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who returned at a particular blood sampling timepoint, were in the ATP immunogenicity cohort in the primary study and for whom serology results were available for that particular timepoint.||subjects|||Number
718783|NCT00289770|Primary|Number of Subjects With Anti-hepatitis A (Anti-HAV) Antibody Concentrations Equal to or Above Cut-off Value|Cut-off value was defined as 15 milli-international units per milliliter (mIU/mL). This was considered as seropositivity.|Years 11, 12, 13, 14 and 15|Analysis was performed on the long-term (LT) According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who returned at a particular blood sampling timepoint, were in the ATP immunogenicity cohort in the primary study and for whom serology results were available for that particular timepoint.||subjects|||Number
718784|NCT00289783|Secondary|Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titer Equal to or Above 1:8.|This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.|Prior to the fourth dose vaccination|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.||Subjects|||Number
718785|NCT00289783|Secondary|Number of Subjects With Anti-PRP Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter (µg/mL).|This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.|Prior to the fourth dose vaccination|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.||Subjects|||Number
718786|NCT00289783|Secondary|Number of Subjects Reporting Adverse Events Resulting in Physicians (MD) Office Visits|physicians (MD) office visits were not related to well-child care, vaccination, injury or common acute illness such as upper respiratory tract infections; otitis media, pharyngitis, gastroenteritis.|From the fourth dose through the end of the 6-month safety follow-up|The Fourth dose Total Vaccinated cohort included all vaccinated subjects in the fourth dose vaccination phase.||Subjects|||Number
718787|NCT00289783|Secondary|Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits|Emergency room (ER) visits were not related to well-child care, vaccination, injury or common acute illness such as upper respiratory tract infections; otitis media, pharyngitis, gastroenteritis.|From the fourth dose through the end of the 6-month safety follow-up|The Fourth dose Total Vaccinated cohort included all vaccinated subjects in the fourth dose vaccination phase.||Subjects|||Number
718788|NCT00289783|Secondary|Number of Subjects Reporting Adverse Events Resulting in Physicians (MD) Office Visits.|physicians (MD) office visits were not related to well-child care, vaccination, injury or common acute illness such as upper respiratory tract infections; otitis media, pharyngitis, gastroenteritis.|From Dose 0 through 6 months after the last primary dose or until administration of the fourth dose|The Primary Total Vaccinated cohort included all vaccinated subjects (Cohort 1, Cohort 2 & Cohort 3) in the primary phase.||Subjects|||Number
718789|NCT00289783|Secondary|Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits|Emergency room (ER) visits were not related to well-child care, vaccination, injury or common acute illness such as upper respiratory tract infections; otitis media, pharyngitis, gastroenteritis.|From Dose 0 through 6 months after the last primary dose or until administration of the fourth dose|The Primary Total Vaccinated cohort included all vaccinated subjects (Cohort 1, Cohort 2 & Cohort 3) in the primary phase.||Subjects|||Number
718790|NCT00289783|Secondary|Number of Subjects Reporting Rash|Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae.|From the fourth dose through the end of the 6-month safety follow-up|The Fourth dose Total Vaccinated cohort included all vaccinated subjects in the fourth dose vaccination phase.||Subjects|||Number
718791|NCT00289783|Secondary|Number of Subjects Reporting Rash|Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae.|From Dose 0 through 6 months after the last primary dose or until administration of the fourth dose|The Primary Total Vaccinated cohort included all vaccinated subjects (Cohort 1, Cohort 2 & Cohort 3) in the primary phase.||Subjects|||Number
718792|NCT00289783|Secondary|Number of Subjects Reporting New Onset of Chronic Illness(es) (NOCDs)|NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.|From the fourth dose through the end of the 6-month safety follow-up|The Fourth dose Total Vaccinated cohort included all vaccinated subjects in the fourth dose vaccination phase.||Subjects|||Number
718793|NCT00289783|Secondary|Number of Subjects Reporting New Onset of Chronic Illness(es) (NOCDs)|NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.|From Dose 0 through 6 months after the last primary dose or until administration of the fourth dose|The Primary Total Vaccinated cohort included all vaccinated subjects (Cohort 1, Cohort 2 & Cohort 3) in the primary phase.||Subjects|||Number
718794|NCT00289783|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|From the fourth dose through the end of the 6-month safety follow-up|The Fourth dose Total Vaccinated cohort included all vaccinated subjects in the fourth dose vaccination phase.||Subjects|||Number
718795|NCT00289783|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|From Dose 0 through 6 months after the last primary dose or untill administration of the fourth dose|The Primary Total Vaccinated cohort included all vaccinated subjects (Cohort 1, Cohort 2 & Cohort 3) in the primary phase.||Subjects|||Number
718796|NCT00289783|Secondary|Number of Subjects Reporting General Symptoms Specific to Measles, Mumps, Rubella and Varicella Vaccination|Symptoms assessed were fever, rash/exanthem, parotid/salivary gland swelling, and any suspected signs of meningism including febrile convulsions. Fever is defined as temperature (rectal or axillary/tympanic) equal to or above 38.0°C.|Within 43 days (Day 0 through Day 42) after vaccination|The Fourth dose Total Vaccinated cohort included all vaccinated subjects in the fourth dose vaccination phase.||Subjects|||Number
718797|NCT00289783|Secondary|Number of Subjects Reporting Increased Circumferential Swelling at the Injection Limb(s)|Increased circumferential swelling defined as either swelling with a diameter of >50 mm or a >50 mm increase in the circumference of the mid-limb when compared to the baseline (pre-vaccination) measurement, or any diffuse swelling that interferes with or prevents everyday activities (for example, active playing, eating, sleeping).|Within 4 days (Day 0 to Day 3) after fourth dose vaccination|The Fourth dose Total Vaccinated cohort included all vaccinated subjects in the fourth dose vaccination phase.||Subjects|||Number
718798|NCT00289783|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within 31 days (Day 0-30) following the fourth dose|The Fourth dose Total Vaccinated cohort included all vaccinated subjects in the fourth dose vaccination phase.||Subjects|||Number
718799|NCT00289783|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within 31 days (Day 0-30) following the primary vaccination course|The Primary Total Vaccinated cohort included all vaccinated subjects (Cohort 1, Cohort 2 & Cohort 3) in the primary phase.||Subjects|||Number
718800|NCT00289783|Secondary|Number of Subjects Reporting Solicited Local and General Symptoms|Solicited local symptoms assessed were pain, redness, swelling and an increase in limb circumference. Solicited general symptoms assessed were fever, irritability/fussiness, drowsiness and lost of appetite. Fever is defined as temperature (rectal or axillary/tympanic) equal to or above 38.0°C|Within the 4 days (Day 0-3) post-vaccination period following the fourth dose|The Fourth dose Total Vaccinated cohort included all vaccinated subjects in the fourth dose vaccination phase.||Subjects|||Number
718801|NCT00289783|Secondary|Number of Subjects Reporting Solicited Local and General Symptoms|Solicited local symptoms assessed were pain, redness and swelling. Solicited genral symptoms assessed were fever, irritability/fussiness, drowsiness and loss of appetite. Fever is defined as temperature (rectal or axillary/tympanic) equal to or above 38.0°C.|Within the 4 days (Day 0-3) following the primary vaccination course|The Primary Total Vaccinated cohort included all vaccinated subjects (Cohort 1, Cohort 2 & Cohort 3) in the primary phase.||Subjects|||Number
718802|NCT00289783|Secondary|Number of Subjects Reporting Fever Above 39.5 Degrees Celsius/103.1 Degrees Fahrenheit|Fever is defined as temperature (rectal or axillary/tympanic) above 39.5 degrees Celsius (°C) or 103.1 degrees Fahrenheit (°F).|In the 4-day (Day0-3) follow-up period after the fourth dose|The Fourth dose Total Vaccinated cohort included all vaccinated subjects in the fourth dose vaccination phase.||Subjects|||Number
718803|NCT00289783|Secondary|Number of Subjects Reporting Fever Above 39.5 Degrees Celsius/103.1 Degrees Fahrenheit|Fever is defined as temperature (rectal or axillary/tympanic) above 39.5 degrees Celsius (°C) or 103.1 degrees Fahrenheit (°F).|In the 4-day (Day 0-3) follow-up period after primary vaccination course|The Primary Total Vaccinated cohort included all vaccinated subjects (Cohort 1, Cohort 2 & Cohort 3) in the primary phase.||Subjects|||Number
718804|NCT00289783|Secondary|Number of Subjects With Anti-H1N1, Anti-H3N2 and Anti-influenza-B (Anti B) Antibody Titers Equal to or Above 1:40|"anti-H1N1, anti-H3N2 and anti-influenza-B (anti B) antibody were measured by hemagglutination inhibition assay (HIA), in subjects who received 2 doses of influenza vaccine within the same influenza season of which at least one dose is concomitant with the study vaccine. For the purposes of this study, concomitant administration of influenza vaccine was defined as administration within 28 days before to 7 days after administration of study vaccines.
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based."|Prior to the fourth dose vaccination and one month after the fourth dose vaccination|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.||Subjects|||Number
718805|NCT00289783|Secondary|Anti-varicella Antibody Titers|"Titers are expressed as Geometric Mean Titers (GMTs)
The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-varicella antibody titers below 1:5
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|42 days after fourth vaccination|The Pooled cohort consisted of all evaluable subjects in the Fourth dose ATP cohort for immunogenicity, HibMenCY-TT-008 and Cohort 1 from HibMenCY-TT-010||Titers||95% Confidence Interval|Geometric Mean
718806|NCT00289783|Secondary|Number of Subjects With Anti-varicella Titer Equal to or Above 1:40|"The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-rubella antibody concentrations below 1:5
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|42 days after fourth vaccination|The Pooled cohort consisted of all evaluable subjects in the Fourth dose ATP cohort for immunogenicity, HibMenCY-TT-008 and Cohort 1 from HibMenCY-TT-010||Subjects|||Number
718807|NCT00289783|Secondary|Anti-rubella Antibody Concentrations|"Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in international units per milliliter (IU/mL).
The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-rubella antibody concentrations below 4 IU/mL.
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|42 days after fourth vaccination|The Pooled cohort consisted of all evaluable subjects in the Fourth dose ATP cohort for immunogenicity, HibMenCY-TT-008 and Cohort 1 from HibMenCY-TT-010||IU/mL||95% Confidence Interval|Geometric Mean
718808|NCT00289783|Secondary|Number of Subjects With Anti-rubella Antibody Concentrations Equal to or Above 4 International Units Per Millilitre (IU/mL)|"The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-rubella antibody concentrations below 4 IU/mL.
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|42 days after fourth vaccination|The Pooled cohort consisted of all evaluable subjects in the Fourth dose ATP cohort for immunogenicity, HibMenCY-TT-008 and Cohort 1 from HibMenCY-TT-010||Subjects|||Number
718809|NCT00289783|Secondary|Anti-mumps Antibody Titers|"Titers are expressed as Geometric Mean Titers (GMTs).
The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-measles antibody titers below 24 ED50.
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|42 days after fourth vaccination|The Pooled cohort consisted of all evaluable subjects in the Fourth dose ATP cohort for immunogenicity, HibMenCY-TT-008 and Cohort 1 from HibMenCY-TT-010.||Titers||95% Confidence Interval|Geometric Mean
718810|NCT00289783|Secondary|Number of Subjects With Anti-mumps Titer Equal to or Above the Cut-off Values|"Anti-mumps antibody cut-off values assessed were >=28 estimated dose 50 (ED50) and >=51 ED50.
The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-mumps antibody titers below 24 ED50.
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|42 days after fourth vaccination|The Pooled cohort consisted of all evaluable subjects in the Fourth dose ATP cohort for immunogenicity, HibMenCY-TT-008 and Cohort 1 from HibMenCY-TT-010.||Subjects|||Number
718811|NCT00289783|Secondary|Anti-measles Antibody Concentrations|"Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in milli-international units per milliliter (mIU/mL).
The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-measles antibody concentrations below 150 mIU/mL.
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|42 days after fourth vaccination|The Pooled cohort consisted of all evaluable subjects in the Fourth dose ATP cohort for immunogenicity, HibMenCY-TT-008 and Cohort 1 from HibMenCY-TT-010.||mIU/mL||95% Confidence Interval|Geometric Mean
718812|NCT00289783|Secondary|Number of Subjects With Anti-measles Antibody Concentrations Equal to or Above 200 Milli-international Units Per Millilitre (mIU/mL)|"The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-measles antibody concentrations below 150 mIU/mL.
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|42 days after fourth vaccination|The Pooled cohort consisted of all evaluable subjects in the Fourth dose ATP cohort for immunogenicity, HibMenCY-TT-008 and Cohort 1 from HibMenCY-TT-010.||Subjects|||Number
718813|NCT00289783|Secondary|Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Concentrations Equal to or Above 1:4|This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.|Prior to the fourth dose vaccination and 42 days after fourth vaccination|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.||Subjects|||Number
718814|NCT00289783|Secondary|Anti-PRP Antibody Concentrations|"Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per millilitre (µg/mL)
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|Prior to the fourth vaccination and 42 days after fourth vaccination|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.||µg/mL||95% Confidence Interval|Geometric Mean
718815|NCT00289783|Secondary|Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above 0.15 Microgram Per Milliliter (µg/mL)|This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.|Prior to the fourth dose vaccination and 42 days after fourth vaccination|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.||Subjects|||Number
718816|NCT00289783|Secondary|Anti-PSC and Anti-PSY Antibody Concentrations|"Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per millilitre (µg/mL).
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|Prior to the fourth dose vaccination and 42 days after fourth dose vaccination|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.||µg/mL||95% Confidence Interval|Geometric Mean
718817|NCT00289783|Secondary|Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values|"Anti-PSC and anti-PSY antibody cut-off values assessed were >=0.3 µg/mL and >=2.0 µg/mL.
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|Prior to the fourth dose vaccination and 42 days after fourth dose vaccination|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.||Subjects|||Number
718818|NCT00289783|Secondary|Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values|"hSBA-MenC and hSBA-MenY antibody cut-off values assessed were >=1:4 and >=1:8.
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|One month after the primary vaccination course|The Primary ATP cohort for immunogenicity included evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures and met no elimination criteria ) for whom assay results were available for antibodies against at least 1 study vaccine antigen for the blood sample taken during primary vaccination (after the 3rd vaccine dose||Subjects|||Number
718819|NCT00289783|Secondary|Anti-PRP Antibody Concentrations|"Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per millilitre (µg/mL).
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|One month after the primary vaccination course and prior to the fourth dose vaccination|The Fourth dose ATP cohort for safety included eligible subjects, who met inclusion criteria, who received 3 vaccine doses in the primary vaccination course, who received the fourth vaccine dose, who did not receive a vaccine not specified or forbidden and who were not excluded from from the Primary ATP cohort for immunogenicity.||µg/mL||95% Confidence Interval|Geometric Mean
718857|NCT00289848|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18|Change from baseline at Week 18 is defined as Week 18 FPG minus Week 0 FPG.|Baseline and Week 18|The full-analysis-set (FAS) population included all patients with at least one dose of double-blind study therapy, and with a baseline value and ≥1 post-baseline value for this outcome. Missing data were handled using the last observation carrying forward (LOCF) method.||mg/dL||95% Confidence Interval|Least Squares Mean
718820|NCT00289783|Secondary|Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above the Cut-off Value|"Anti-PRP antibody cut-off values assessed were >=0.15 µg/mL.
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|One month after the primary vaccination course|The Primary ATP cohort for immunogenicity included evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures and met no elimination criteria) for whom assay results were available for antibodies against at least 1 study vaccine antigen for the blood sample taken during primary vaccination (after the 3rd vaccine dose.||Subjects|||Number
718821|NCT00289783|Secondary|Anti-PSC and Anti-PSY Antibody Concentrations|"Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per millilitre (µg/mL).
The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis."|Prior to the fourth dose vaccination and one month after fourth dose vaccination|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.||µg/mL||95% Confidence Interval|Geometric Mean
718822|NCT00289783|Secondary|Anti-PSC and Anti-PSY Antibodies Concentrations|"Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per milliliter (µg/mL).
The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis."|One month after the primary vaccination course|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.||µg/mL||95% Confidence Interval|Geometric Mean
718823|NCT00289783|Secondary|Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values|"Anti-PSC and anti-PSY antibody cut-off values assessed were >=0.3 µg/mL and >=2.0 µg/mL.
The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis."|Prior to the fourth dose vaccination and one month after fourth dose vaccination|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.||Subjects|||Number
718824|NCT00289783|Secondary|Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values|"Anti-PSC and anti-PSY antibody cut-off values assessed were >=0.3 microgram per milliliter (µg/mL) and >=2.0 µg/mL.
The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis."|One month after the primary vaccination course|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.||Subjects|||Number
718825|NCT00289783|Secondary|hSBA-MenC and hSBA-MenY Antibody Titers|"Titers are expressed as Geometric Mean Titers (GMTs)
The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis."|Prior to the fourth dose vaccination and one month after fourth dose vaccination|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.||Titers||95% Confidence Interval|Geometric Mean
718826|NCT00289783|Secondary|hSBA-MenC and hSBA-MenY Antibody Titers|"Titres are expressed as Geometric Mean Titers (GMTs).
The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis."|One month after the primary vaccination course|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.||Titers||95% Confidence Interval|Geometric Mean
718827|NCT00289783|Secondary|Number of Subjects With hSBA-MenC and hSBA-MenY Titers Equal to or Above the Cut-off Values|"hSBA-MenC/Y antibody cut-off values assessed were >=1:4 and >=1:8.
The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis."|Prior to the fourth dose vaccination and one month after fourth dose vaccination|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.||Subjects|||Number
718858|NCT00289848|Primary|Change From Baseline in Hemoglobin A1c (HbA1c) at Week 18|A1C was measured as a percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.|Baseline and Week 18|The full-analysis-set (FAS) population included all patients with at least one dose of double-blind study therapy, and with a baseline value and ≥1 post-baseline value for this outcome. Missing data were handled using the last observation carrying forward (LOCF) method.||Percent||95% Confidence Interval|Least Squares Mean
718828|NCT00289783|Secondary|Number of Subjects With hSBA-MenC and hSBA-MenY Titers Equal to or Above the Cut-off Values|"hSBA-MenC/Y antibody cut-off values assessed were >=1:4 and >=1:8
The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis."|One month after the primary vaccination course|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.||Subjects|||Number
718829|NCT00289783|Secondary|Anti-PRP Antibody Concentrations|"Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per millilitre (µg/mL)
The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis."|Prior to the fourth dose vaccination and one month after fourth dose vaccination|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.||µg/mL||95% Confidence Interval|Geometric Mean
718830|NCT00289783|Secondary|Anti-PRP Antibody Concentrations|"Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per millilitre (µg/mL)
The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis."|One month after the primary vaccination course|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.||µg/mL||95% Confidence Interval|Geometric Mean
718831|NCT00289783|Secondary|Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above the Cut-off Values|"Anti-PRP antibody cut-off values assessed were >=0.15 microgram per milliliter (µg/mL) and >=1.0 µg/mL.
The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis."|Prior to the fourth dose vaccination and one month after fourth dose vaccination|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.||Subjects|||Number
718832|NCT00289783|Secondary|Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above the Cut-off Values|"Anti-PRP antibody cut-off values assessed were >=0.15 microgram per milliliter (µg/mL) and >=1.0 µg/mL.
The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis."|One month after the primary vaccination course|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.||Subjects|||Number
718833|NCT00289783|Secondary|Anti-PSC and Anti-PSY Antibody Concentrations|"Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per milliliter (µg/mL)
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|One month after primary vaccination|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.||µg/mL||95% Confidence Interval|Geometric Mean
718834|NCT00289783|Secondary|Number of Subjects With Antibodies to Neisseria Meningitidis Serogroup C and Y Polysaccharide Capsule (Anti-PSC and Anti-PSY) Concentrations Equal to or Above the Cut-off Values|"Anti-PSC and anti-PSY antibody cut-off values assessed were >=0.3 microgram per milliliter (µg/mL) and >=2.0 µg/mL.
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|One month after primary vaccination|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.||Subjects|||Number
718835|NCT00289783|Secondary|Anti-poliovirus Types 1, 2 and 3 Titers|"Titers are expressed as Geometric Mean Titers (GMTs)
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|One month after primary vaccination|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.||Titers||95% Confidence Interval|Geometric Mean
718836|NCT00289783|Secondary|Number of Subjects With Anti-poliovirus Types 1, 2 and 3 Equal to or Above 8 Estimated Dose 50 (ED50)|This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.|One month after primary vaccination|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.||Subjects|||Number
718837|NCT00289783|Secondary|Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations|This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.|One month after primary vaccination|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.||EL.U/mL||95% Confidence Interval|Geometric Mean
718838|NCT00289783|Secondary|Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Equal to or Above 5 ELISA Units Per Millilitre (EL.U/mL)|This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.|One month after primary vaccination|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.||Subjects|||Number
718839|NCT00289783|Secondary|Anti-HBS Antibody Concentrations|"Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in milli-International units per milliliter (mIU/mL)
Results are stratified by the presence or absence of a birth dose of hepatitis B vaccine.
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|One month after primary vaccination|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.||mIU/mL||95% Confidence Interval|Geometric Mean
718840|NCT00289783|Secondary|Number of Subjects With Anti Hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above 10.0 Milli-international Units Per Millilitre (mIU/mL)|"Results are stratified by the presence or absence of a birth dose of hepatitis B vaccine.
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|One month after primary vaccination|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.||Subjects|||Number
718841|NCT00289783|Secondary|Anti-D and Anti-T Antibody Concentrations|"Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in international units per milliliter (IU/mL).
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|One month after primary vaccination|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.||IU/mL||95% Confidence Interval|Geometric Mean
718842|NCT00289783|Secondary|Number of Subjects With Anti-tetanus (Anti-T) and Anti-diphtheria Toxoid (Anti-D) Antibody Concentrations Equal to or Above 0.1 International Units Per Millilitre (IU/mL)|This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.|One month after primary vaccination|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.||Subjects|||Number
718843|NCT00289783|Primary|Number of Subjects With Anti-varicella Titer Equal to or Above 1:5|"The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-measles antibody titer below 1:5.
Co-administration with Varivax vaccine."|42 days after the fourth dose|The Pooled cohort consisted of all evaluable subjects in the Fourth dose ATP cohort for immunogenicity, HibMenCY-TT-008 and Cohort 1 from HibMenCY-TT-010.||Subjects|||Number
718844|NCT00289783|Primary|Number of Subjects With Anti-rubella Antibody Concentrations Equal to or Above 10 International Units Per Milli-litre (IU/mL)|"The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-measles antibody concentrations below 4 IU/mL.
Co-administration with MMR-II vaccine."|42 days after the fourth dose|The Pooled cohort consisted of all evaluable subjects in the Fourth dose ATP cohort for immunogenicity, HibMenCY-TT-008 and Cohort 1 from HibMenCY-TT-010.||Subjects|||Number
718845|NCT00289783|Primary|Number of Subjects With Anti-mumps Titer Equal to or Above 28 Estimated Dose 50 (ED50)|"The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-mumps antibody titers below 28 ED50
Co-administration with MMR-II vaccine."|42 days after the fourth dose|The Pooled cohort consisted of all evaluable subjects in the Fourth dose ATP cohort for immunogenicity, HibMenCY-TT-008 and Cohort 1 from HibMenCY-TT-010.||Subjects|||Number
718846|NCT00289783|Primary|Number of Subjects With Anti-measles Antibody Concentrations Equal to or Above 150 Milli-international Units Per Milli-liter (mIU/ML)|"The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-measles antibody concentrations below 150 mIU/mL.
Co-administration with MMR-II vaccine"|42 days after the fourth dose|The Pooled cohort consisted of all evaluable subjects in the Fourth dose ATP cohort for immunogenicity, HibMenCY-TT-008 and Cohort 1 from HibMenCY-TT-010.||Subjects|||Number
718859|NCT00289874|Secondary|"Percent Change From Baseline in Mean Daily as Needed β-agonist Use Over the 3-week Treatment Period"|Percent change from baseline in average daily β-agonist use over the 3-week treatment period|Baseline and Week 3|The full analysis set population (i.e., includes all patients who had baseline and on-treatment measurements).||Percent Change||Standard Deviation|Median
718847|NCT00289783|Primary|Number of Subjects With Anti-PRP Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter|This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.|42 days after the fourth dose|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.||Subjects|||Number
718848|NCT00289783|Primary|Number of Subjects With hSBA-MenY Titer Equal to or Above 1:8|This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.|42 days after the fourth dose|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.||Subjects|||Number
718849|NCT00289783|Primary|Number of Subjects With hSBA-MenC Titer Equal to or Above 1:8|This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.|42 days after the fourth dose|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.||Subjects|||Number
718850|NCT00289783|Primary|Number of Subjects With Anti-PRP Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter (µg/mL)|This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.|One month after primary vaccination|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.||Subjects|||Number
718851|NCT00289783|Primary|hSBA-MenY Antibody Titers|"Titers are expressed as Geometric Mean Titers (GMTs)
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|Prior to the fourth dose vaccination and 42 days after the fourth dose|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.||Titers||95% Confidence Interval|Geometric Mean
718852|NCT00289783|Primary|hSBA-MenC Antibody Titers|"Titers are expressed as Geometric Mean Titers (GMTs)
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|Prior to the fourth dose vaccination and 42 days after the fourth dose|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.||Titers||95% Confidence Interval|Geometric Mean
718853|NCT00289783|Primary|Neisseria Meningitidis Serogroup Y (MenY) Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers|"Titers are expressen as Geometric Mean Titers (GMTs)
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|One month after primary vaccination|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.||Titers||95% Confidence Interval|Geometric Mean
718854|NCT00289783|Primary|Neisseria Meningitidis Serogroup C (MenC) Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers|"Titers were expressed as Geometric Mean Titers (GMTs)
This analysis occured on the cohort 1 : Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|One month after primary vaccination|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.||Titers||95% Confidence Interval|Geometric Mean
718855|NCT00289783|Primary|Anti-Polyribosyl Ribitol Phosphate (PRP) Antibody Concentrations|"Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per millilitre (µg/mL)
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|One month after primary vaccination|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.||microgram per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
718856|NCT00289848|Secondary|Change From Baseline in 2-hr Post-Meal Glucose (PMG) at Week 18|Change from baseline at Week 18 is defined as Week 18 minus Week 0.|Baseline and Week 18|The full-analysis-set (FAS) population included all patients with at least one dose of double-blind study therapy, and with a baseline value and ≥1 post-baseline value for this outcome. Missing data were handled using the last observation carrying forward (LOCF) method.||mg/dL||95% Confidence Interval|Least Squares Mean
718860|NCT00289874|Primary|Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 3|Percent change from baseline in FEV1, a measure of airway function, at Week 3|Baseline and week 3|The full analysis set population (i.e., includes all patients who had baseline and on-treatment measurements).||Percent Change||95% Confidence Interval|Least Squares Mean
718861|NCT00289887|Primary|Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 16|"Mean change from baseline in trough (6 hours after the last morning dose) SiDBP at Week 16.
A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline."|At baseline and at 16 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)|"An all patients treated approach was employed, patients included had at least 1 dose post baseline and 1 measurement at baseline and during treatment."||mm Hg||Standard Error|Least Squares Mean
718862|NCT00289887|Primary|Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 16|"Mean change from baseline in trough (6 hours after last morning dose) SiSBP at Week 16.
A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline."|At baseline and at 16 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)|"An all patients treated approach was employed, patients included had at least 1 dose post baseline and 1 measurement at baseline and during treatment."||mm Hg||Standard Error|Least Squares Mean
718863|NCT00289887|Primary|Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 12|"Mean change from baseline in trough (6 hours after last morning dose) SiSBP at Week 12.
A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline."|At baseline and at 12 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)|"An all patients treated approach was employed, patients included had at least 1 dose post baseline and 1 measurement at baseline and during treatment."||mm Hg||Standard Error|Least Squares Mean
718864|NCT00289887|Primary|Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12|"Mean change from baseline in trough (6 hours after the last morning dose) SiDBP at Week 12.
A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline."|At baseline and at 12 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)|"An all patients treated approach was employed, patients included had at least 1 dose post baseline and 1 measurement at baseline and during treatment."||mm Hg||Standard Error|Least Squares Mean
718865|NCT00289887|Primary|Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 8|"Mean change from baseline in trough (6 hours after the last morning dose) SiDBP at Week 8.
A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline."|At baseline and at 8 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)|"An all patients treated approach was employed, patients included had at least 1 dose post baseline and 1 measurement at baseline and during treatment."||mm Hg||Standard Error|Least Squares Mean
718866|NCT00289887|Primary|Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 8|"Mean change from baseline in trough (6 hours after last morning dose) SiSBP at Week 8.
A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline."|At baseline and at 8 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)|"An all patients treated approach was employed, patients included had at least 1 dose post baseline and 1 measurement at baseline and during treatment."||mm Hg||Standard Error|Least Squares Mean
718867|NCT00289900|Secondary|Percentage of Participants Who Experience at Least 1 Hepatitis-related Clinical AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. Hepatitis-related AEs were identified by a collective review using the following pre-specified set of preferred terms: cholestasis, hepatic necrosis, hepatocellular damage, cytolytic hepatitis, hepatitis, hepatomegaly, jaundice, hepatic failure, hepatitis cholestatic, jaundice cholestatic, hepatitis fulminant, hyperbilirubinaemia, jaundice hepatocellular, ocular icterus, yellow skin, hepatic function abnormal, acute hepatic failure, subacute hepatic failure, hepatitis acute, hepatitis toxic, hepatotoxicity, and mixed hepatocellular-cholestatic injury.|up to 14 weeks|All participants who had taken at least 1 dose of study medication. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.||Percentage of Participants|||Number
718868|NCT00289900|Secondary|Percentage of Participants Who Were Discontinued From the Study Due to a Laboratory AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test. Participants who were discontinued from the study due to a laboratory AE were recorded.|up to 14 weeks|All participants who had taken at least 1 dose of study medication and had data available for endpoint. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.||Percentage of Participants|||Number
718877|NCT00289900|Secondary|Percentage of Participants With Creatine Kinase (CK) >=10 x ULN|Participants had CK assessed throughout the 12 week treatment period. Participants who had any CK level that was >=10 x ULN were recorded. The UNLs for males and females were 207 U/L and 169 U/L, respectively.|up to 12 weeks|All participants who had taken at least 1 dose of study medication and had data available for endpoint. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.||Percentage of Participants|||Number
718869|NCT00289900|Secondary|Percentage of Participants Who Were Discontinued From the Study Due to a Clinical AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. A clinical AE was an AE reported as a result of a clinical examination or reported by the participant. Participants who were discontinued from the study due to a clinical AE were recorded.|up to 14 weeks|All participants who had taken at least 1 dose of study medication and had data available for endpoint. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.||Percentage of Participants|||Number
718870|NCT00289900|Secondary|Percentage of Participants Who Experience at Least 1 Laboratory Adverse Event (AE)|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test.|up to 14 weeks|All participants who had taken at least 1 dose of study medication and had data available for endpoint. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.||Percentage of Participants|||Number
718871|NCT00289900|Secondary|Percentage of Participants Who Experience at Least 1 Clinical Adverse Event (AE)|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. A clinical AE was an AE reported as a result of a clinical examination or reported by the participant.|up to 14 weeks|All participants who had taken at least 1 dose of study medication. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.||Percentage of Participants|||Number
718872|NCT00289900|Secondary|Percentage of Participants With a Confirmed Adjudicated Cardiovascular Event|Select serious adverse cardiovascular events and all-cause mortality that occurred during the treatment phase of the study were adjudicated by an expert committee external to the sponsor. Those events confirmed by the committee a cardiovascular events were recorded.|up to 14 weeks|All participants who had taken at least 1 dose of study medication. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.||Percentage of Participants|||Number
718873|NCT00289900|Secondary|Percentage of Participants With New Diagnosis of Diabetes|Participants had blood glucose levels assessed throughout the 12 week treatment period. Participants who with newly diagnosed of diabetes were recorded. A participant was classified as having new onset diabetes if they experienced an adverse Event (AE) related to a diagnosis of diabetes (based on a pre-defined set of Medical Dictionary for Regulatory Activities [MedDRA] terms), or if they started taking an anti-diabetic medication during the course of the study. The MedDRA terms were as follows: diabetes mellitus, diabetes mellitus insulin-dependent, diabetes mellitus non-insulin dependent, insulin-requiring type II diabetes mellitus, insulin resistant diabetes, diabetes with hyperosmolarity, latent autoimmune diabetes in adults.|up to 12 weeks|All participants who had taken at least 1 dose of study medication and did not have diabetes at baseline. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.||Percentage of Participants|||Number
718874|NCT00289900|Secondary|Percentage of Participants With New Diagnosis of Impaired Fasting Blood Glucose|Participants had blood glucose levels assessed throughout the 12 week treatment period. Participants who had the new diagnosis of impaired fasting blood glucose were recorded. A pre-defined set of MedDRA terms was used to identify participants whose glycemic status became ‘impaired’ during the course of treatment (from clinical adverse experience reports). The MedDRA terms were as follows: blood glucose increased, blood glucose abnormal, glucose tolerance decreased, glucose tolerance test abnormal, carbohydrate tolerance decreased, glucose tolerance impaired, hyperglycaemia, impaired fasting glucose, impaired insulin secretion, metabolic syndrome, insulin resistance, insulin resistance syndrome.|up to 12 weeks|All participants who had taken at least 1 dose of study medication and normal glycemic status at baseline. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.||Percentage of Participants|||Number
718875|NCT00289900|Secondary|Percentage of Participants With CK >=10 x ULN With Muscle Symptoms - Drug Related|Participants had CK assessed throughout the 12 week treatment period. Participants who had any CK level that was >=10 x ULN and had associated muscle symptoms present within +/- 7 days that were reported as at least possibly related to study drug were recorded. The UNLs for males and females were 207 U/L and 169 U/L, respectively.|up to 12 weeks|All participants who had taken at least 1 dose of study medication and had data available for endpoint. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.||Percentage of Participants|||Number
718876|NCT00289900|Secondary|Percentage of Participants With CK >=10 x ULN With Muscle Symptoms|Participants had CK assessed throughout the 24 week treatment period. Participants who had any CK level that was >=10 x ULN and had associated muscle symptoms present within +/- 7 days were recorded. The UNLs for males and females were 207 U/L and 169 U/L, respectively.|up to 12 weeks|All participants who had taken at least 1 dose of study medication and had data available for endpoint. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.||Percentage of Participants|||Number
718900|NCT00289991|Secondary|Duration of Treatment|Median duration in days of treatment. Treatment is defined as the total number of days on which subjects took medication.|Day 1 up to Day 180|MITT; data from 1 site excluded due to GCP deviations.||days||Full Range|Median
718878|NCT00289900|Secondary|Percentage of Participants With Elevations in ALT and/or AST of >=10 x ULN|Participants had AST and ALT levels assessed throughout the 12 week treatment period. Participants who had an assessment of either AST or ALT that was 10 x ULN or greater were recorded. The AST UNLs for males and females were 43 U/L and 36 U/L, respectively. The ALT UNLs for males and females were 40 U/L and 33 U/L, respectively.|up to 12 weeks|All participants who had taken at least 1 dose of study medication and had data available for endpoint. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.||Percentage of Participants|||Number
718879|NCT00289900|Secondary|Percentage of Participants With Elevations in ALT and/or AST of >=5 x ULN|Participants had AST and ALT levels assessed throughout the 12 week treatment period. Participants who had an assessment of either AST or ALT that was 5 x ULN or greater were recorded. The AST UNLs for males and females were 43 U/L and 36 U/L, respectively. The ALT UNLs for males and females were 40 U/L and 33 U/L, respectively.|up to 12 weeks|All participants who had taken at least 1 dose of study medication and had data available for endpoint. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.||Percentage of Participants|||Number
718880|NCT00289900|Secondary|Percentage of Participants With Consecutive Elevations in Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) of >=3 x Upper Limit of Normal (ULN)|Participants had AST and ALT levels assessed throughout the 12 week treatment period. Participants who had 2 consecutive assessments of either AST or ALT that were 3 x ULN or greater were recorded. The AST UNLs for males and females were 43 U/L and 36 U/L, respectively. The ALT UNLs for males and females were 40 U/L and 33 U/L, respectively.|up to 12 weeks|All participants who had taken at least 1 dose of study medication and had data available for endpoint. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.||Percentage of Participants|||Number
718881|NCT00289900|Secondary|Percentage Change From Baseline in TC/HDL-C Ratio|Blood samples taken at baseline and after 12 weeks of treatment to determine the TC and HDL-C levels. The TC/HDL-C ratio was then calculated for baseline and Week 12 and the change from baseline at Week 12 was recorded.|Baseline and Week 12|All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint.||Percentage change||95% Confidence Interval|Least Squares Mean
718882|NCT00289900|Secondary|Percentage Change From Baseline in C-reactive Protein (CRP)|Blood samples taken at baseline and after 12 weeks of treatment to determine the CRP levels. The change from baseline at Week 12 was recorded.|Baseline and Week 12|All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint.||Percentage change||95% Confidence Interval|Median
718883|NCT00289900|Secondary|Percentage Change From Baseline in Lipoprotein (a) (Lp[a])|Blood samples taken at baseline and after 12 weeks of treatment to determine the Lp(a) levels. The change from baseline at Week 12 was recorded.|Baseline and Week 12|All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint.||Percentage change||95% Confidence Interval|Median
718884|NCT00289900|Secondary|Percentage Change From Baseline in Total Cholesterol (TC)|Blood samples taken at baseline and after 12 weeks of treatment to determine the TC levels. The change from baseline at Week 12 was recorded.|Baseline and Week 12|All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint.||Percentage change||95% Confidence Interval|Least Squares Mean
718885|NCT00289900|Secondary|Percentage Change From Baseline in Apo A-I|Blood samples taken at baseline and after 12 weeks of treatment to determine the Apo A-I levels. The change from baseline at Week 12 was recorded.|Baseline and Week 12|All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint.||Percentage change||95% Confidence Interval|Least Squares Mean
718886|NCT00289900|Secondary|Percentage Change From Baseline in Apolipoprotein (Apo) B|Blood samples taken at baseline and after 12 weeks of treatment to determine the Apo B levels. The change from baseline at Week 12 was recorded.|Baseline and Week 12|All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint.||Percentage change||95% Confidence Interval|Least Squares Mean
718887|NCT00289900|Secondary|Percentage Change From Baseline in LDL-C|Blood samples taken at baseline and after 12 weeks of treatment to determine the LDL-C levels. The change from baseline at Week 12 was recorded.|Baseline and Week 12|All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint.||Percentage change||95% Confidence Interval|Least Squares Mean
718888|NCT00289900|Secondary|Percentage Change From Baseline in Non-HDL-C|Blood samples taken at baseline and after 12 weeks of treatment to determine the non-HDL-C levels. The change from baseline at Week 12 was recorded.|Baseline and Week 12|All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint.||Percentage change||95% Confidence Interval|Least Squares Mean
718889|NCT00289900|Secondary|Percentage Change From Baseline in Triglycerides (TG)|Blood samples taken at baseline and after 12 weeks of treatment to determine the TG levels. The change from baseline at Week 12 was recorded.|Baseline and Week 12|All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint.||Percentage change||95% Confidence Interval|Median
718890|NCT00289900|Secondary|Percentage Change From Baseline in HDL-C|Blood samples taken at baseline and after 12 weeks of treatment to determine the HDL-C levels. The change from baseline at Week 12 was recorded.|Baseline and Week 12|All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint.||Percentage change||95% Confidence Interval|Least Squares Mean
721691|NCT00321828|Secondary|Local Complications as Assessed by Colonic Obstruction Requiring Hospitalization (But Not Surgery) for Medical Management, Stent Placement, Laser Treatment, or Fulguration||Time from start of study through year 5||||||
718891|NCT00289900|Primary|Percentage Change From Baseline in the LDL-C/HDL-C Ratio|Blood samples taken at baseline and after 12 weeks of treatment to determine the LDL-C and HDL-C levels. The LDL-C/HDL-C ratio was then calculated for baseline and Week 12 and the change from baseline at Week 12 was recorded.|Baseline and Week 12|All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint.||Percentage Change||95% Confidence Interval|Least Squares Mean
718892|NCT00289913|Primary|Geometric Mean Titers (GMTs) to Antibodies for the Pertussis Toxin (PT), Pertussis Filamentous Hemagglutinin Antibody (FHA), and Pertactin (PRN) Components of Infanrix™|"GMTs for antibodies to PT, FHA, and PRN were measured in serum samples of participants vaccinated with Infanrix™.
IgG antibodies to PT were assessed using the anti-pertussis toxin enzyme-linked immunosorbent assay (anti-PT ELISA), with the LOD of 2.4 ELU/mL.
IgG antibodies to FHA were assessed using the anti-pertussis filamentous hemagglutinin enzyme-linked immunosorbent assay (anti-FHA ELISA), with the LOD of 2.0 ELU/mL.
IgG antibodies to PRN were assessed using the anti-pertussis pertactin enzyme-linked immunosorbent assay (anti-PRN ELISA), with the LOD of 3.3 ELU/mL."|4 weeks postvaccination with Infanrix™|The per-protocol population, which consisted of all Stage I participants who received vaccinations within the specified day ranges, completed appropriate follow-up, and were without any pre-specified protocol violations.||ELISA units per mL (ELU/mL)||95% Confidence Interval|Geometric Mean
718893|NCT00289913|Primary|Number of Participants With Adverse Events (AE)|"Systemic and injection site AEs were collected from participants receiving
VAQTA™ concomitantly with Infanrix™ and PedvaxHIB™ or PedvaxHIB™ (Stage I)
VAQTA™ non-concomitantly with Infanrix™ and PedvaxHIB™ or PedvaxHIB™ (Stage I)
VAQTA™ administered alone (Stage II)
Safety data was collected on a standardized Vaccination Report Card (VRC)
following each dose. Participants returned the VRC after the safety follow-up period for each dose of VAQTA™. AEs determined by the investigator to be possibly, probably or definitely related to the vaccine are reported as Vaccine-related AE."|Days 1 to 14 after any dose of VAQTA™ for systemic AEs, and Days 1 to 5 after any dose of VAQTA™ for injection-site AEs|Participants administered at least one dose of vaccine, for whom follow-up was available.||Participants|||Number
718894|NCT00289913|Primary|Antibody Response Rate to Haemophilus Influenzae Type b (Hib)|"Antibodies to the Hib capsular polysaccharide (polyribosylribitol phosphate [PRP]) are assessed in participants serum using radioimmunoassay (RIA). The limit of detection (LOD) for the RIA is 6.60 ng/mL.
The antibody response rate is defined as the percentage of participants with anti-PRP titers >1.0 mcg/mL, 4 weeks postvaccination with PedvaxHIB™."|4 weeks postvaccination with PedvaxHIB™|The per-protocol population, which consisted of all Stage I participants who received vaccinations within the specified day ranges, completed appropriate follow-up, and were without any pre-specified protocol violations.||Percentage of participants||95% Confidence Interval|Number
718895|NCT00289913|Primary|Seropositivity Rate (SPR) to Hepatitis A|SPR is the percent of participants with Hepatitis A antibody titers >= 10 milli-International Units/milliliter (mIU/mL), 4 weeks after dose 2 of VAQTA™ regardless of their initial serostatus. Antibody titers to Hepatitis A virus (HAV) were detected in participants' serum samples using an Enzyme Immunoassay (EIA).|4 weeks after dose 2 of VAQTA™|The per-protocol population, which consisted of all Stage I participants who received vaccinations within the specified day ranges, completed appropriate follow-up, and were without any pre-specified protocol violations.||Percentage of participants||95% Confidence Interval|Number
718896|NCT00289978|Secondary|Number of New or Newly Enlarged T2 Lesions at Month 24 in Comparison With Baseline|The number of new or newly enlarged T2 lesions at Month 24 in comparison to baseline was assessed with T2-weighted magnetic resonance image (MRI) scans. A T2-weighted MRI scan utilizes particular values of the echo time (TE) and the repetition time (TR) parameters of image acquisition. Inflammation and tissue damage are seen as bright areas in T2 images and are often referred to as T2 lesions. T2-weighted MRI scans are a sensitive way to evaluate the brain for demyelinating diseases, such as multiple sclerosis.|Baseline to end of study (Month 24)|Intent-to-treat population (ITT): All patients who were randomized and received at least one dose of study medication.||T2 lesions|Participants|Standard Deviation|Mean
718897|NCT00289978|Secondary|Percentage of Patients Free of Disability Progression at Month 24 Assessed With the Expanded Disability Status Scale (EDSS)|EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) is calculated. Disability progression was determined by the following: One point increase from baseline in patients with baseline EDSS score from 0 to 5.0; or half a point increase in patients with baseline EDSS score of 5.5 or above. A 3-month confirmed disability progression required onset EDSS, 3-month confirming EDSS, and all EDSS in between to meet the disability progression criteria. Percent of free of disability progression was calculated using the Kaplan Meier method.|Baseline to end of study (Month 24)|Intent-to-treat population (ITT): All patients who were randomized and received at least one dose of study medication.||Percentage of participants||95% Confidence Interval|Number
718898|NCT00289978|Primary|Estimated Annualized Aggregate Relapse Rate (ARR)|The ARR is defined as the number of confirmed relapses in a year. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. The annualized ARR for each treatment group was the mean of the annualized ARRs for all patients in the group calculated as the total number of confirmed relapses divided by the total number of days on study, multiplied by 365.25.|Baseline to end of study (Month 24)|This analysis was conducted using the Intent-to-treat (ITT) population which includes all patients who were randomized and received at least one dose of study drug.||Relapses per year||95% Confidence Interval|Number
718899|NCT00289991|Secondary|Percent of Subjects With Use of Other Systemic Antifungal Agents as Empirical or Therapeutic Treatment|Percent of subjects who used other systemic antifungal agents as empirical or therapeutic treatment, defined as either empirical: subject took a systemic antifungal agent at any time after the day of first dose of medication and did not develop a breakthrough proven or probable IFI during the study or therapeutic: subject developed a breakthrough proven or probable IFI.|Day 1 up to Day 180|MITT; data from 1 site excluded due to GCP deviations. Subjects who developed a breakthrough proven or probable IFI were identified only from the study database, not the EORTC/MSG worksheet. In addition, all agents identified to be antifungals were considered to be systemic.||percent of participants|||Number
718901|NCT00289991|Secondary|Survival: Percent of Subjects Who Died Within 1 Year|Percent of subjects who died within 1 year after transplant, derived from the crude death rate. All subjects in the MITT population included in this proportion. Only deaths up until and including 365 days after first dose of study medication included in the analysis.|Day 1 up to 1 year (Day 365)|MITT; data from 1 site excluded due to GCP deviations. Typically, subjects received first dose study treatment on the day of their transplant; however, some subjects started treatment up to 48 hours after transplant. Data summarized with first day of study medication defined as Day 1.||percent of participants|||Number
718902|NCT00289991|Secondary|Time to Discontinuation of Study Treatment|Time in days to discontinuation of study treatment defined as the number of days from first dose to last dose inclusive as recorded in the dosing log.|Day 1 up to Day 180 (Visit 9)|MITT; data from 1 site excluded due to GCP deviations.||days||95% Confidence Interval|Mean
718903|NCT00289991|Secondary|Survival: Percent of Subjects Who Died at or Before Day 180|Percent of subjects who died at or before Day 180, derived from the crude death rate. All subjects in the MITT population included in this proportion.|Day 1 up to Day 180 (Visit 9)|MITT; data from 1 site excluded due to GCP deviations. Analysis does not include any deaths recorded in the long-term follow-up data (not available at time of analysis).||percent of participants|||Number
718904|NCT00289991|Secondary|Percent of Subjects With Occurrence of Breakthrough IFI|Percent of subjects with occurrence of breakthrough IFI (proven or probable). Included all subjects in the MITT population.|Day 1 up to Day 100 (Visit 7) and Day 180 (Visit 9)|MITT; data from 1 site excluded due to GCP deviations. Analysis excludes additional data on IFIs that were only captured on EORTC/MSG worksheets (not on Case Report Forms or in the database).||percent of participants|||Number
718905|NCT00289991|Secondary|Time to Breakthrough Invasive Fungal Infection (IFI)|Summary of time (in days) from start of prophylaxis to first recorded occurrence of breakthrough proven or probable IFI.|Day 1 up to Day 180 (Visit 9)|MITT; data from 1 site excluded due to GCP deviations. Analysis excludes additional data on IFIs that were only captured on European Organization for Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG) worksheets (not on Case Report Forms or in the database). Times were summarized only for subjects who experienced a breakthrough IFI.||days||95% Confidence Interval|Mean
718906|NCT00289991|Secondary|Success at Day 100: Percent of Responders (Randomization Strata)|Percent of responders (by randomization strata) with success of antifungal prophylaxis at 100 days after allogeneic HSCT. Success defined as: alive at Day 100 (Visit 7), had not developed a breakthrough proven or probable IFI by Visit 7, and received full course of study drug prophylaxis without an interruption of >14 days in total during the prophylaxis period; defined as failure if these criteria were not met. Additionally, if subject withdrew from study completely before Visit 7, imputed as failure at Visit 7 (programmatically).|Day 100 (Visit 7)|MITT; data from 1 site excluded due to GCP deviations; (n)=number of subjects with analyzable data at observation for voriconazole and itraconazole, respectively.||percent of participants|||Number
718907|NCT00289991|Primary|Success at Day 180: Percent of Responders (Randomization Strata)|Percent of responders (by randomization strata) with success of antifungal prophylaxis at 180 days after allogeneic hematopoietic stem cell transplant (HSCT). Success: alive at Day 180 (Visit 9), had not developed a breakthrough proven or probable invasive fungal infection (IFI) by Visit 9, and received full course of study drug prophylaxis without interruption of greater than 14 days in total during the prophylaxis period; defined as failure if these criteria were not met. Additionally, if subject withdrew from study completely before Visit 9, imputed as failure at Visit 9 (programmatically).|Day 180 (Visit 9)|Modified Intent to Treat (MITT): primary analysis population; all randomized subjects: received at least 1 dose of randomized study drug and had allogeneic HSCT; data from 1 site excluded due to Good Clinical Practice (GCP) deviations; (n)=number of subjects with analyzable data at observation for voriconazole and itraconazole, respectively.||percent of participants|||Number
718908|NCT00290147|Secondary|Anti-dengue Antibody and T-cell and B-cell Responders|Number of participants who responded, are reported. Response or a positive ELISPOT assay was defined as >65 spot forming cells per million PBMC for T-cells and >20 spot forming cells per million PBMC for B-cells|12 months|||Participants|||Count of Participants
718909|NCT00290147|Primary|Systemic and Local Reactogenicity Rates for Ungraded Symptoms|Summary of ungraded systemic and local reactogenicity symptoms following each vaccination|Months 0, 1 and 5|||Participants|||Count of Participants
718910|NCT00290186|Secondary|The Difference Between Groups in Change in Scores (Post-treatment Minus Pre-treatment) on the Test of Variables of Attention (TOVA): Response Time Variability in Milliseconds|One of 4 parts of the TOVA, a computerized continuous performance test that measures attention and impulsivity in visual mode. Measures the variability in processing time in milliseconds that it takes to correctly respond to a target. Response time variability = the standard deviation of response times for correct responses. Lower values represent less variability and better responses. Range of response times = 0-2000 milliseconds.|Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)|The TOVA was only administered to patients who were 4-8 years old, not visually impaired, and able to complete a practice test. Analysis included all eligible participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment).||time in milliseconds||95% Confidence Interval|Mean
718911|NCT00290186|Secondary|The Difference Between Groups in Change in Scores (Post-treatment Minus Pre-treatment) on the Test of Variables of Attention (TOVA): Response Time in Milliseconds|One of 4 parts of the TOVA, a computerized continuous performance test that measures attention and impulsivity in visual mode. Measures the processing time in milliseconds that it takes to correctly respond to a target. Lower times represent better response times. Range = 0 - 2000 milliseconds|Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)|The TOVA was only administered to patients who were 4-8 years old, not visually impaired, and able to complete a practice test. Analysis included all eligible participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment).||time in milliseconds||95% Confidence Interval|Mean
719149|NCT00294645|Secondary|Percentage of Participants With an Increase in Atrial Pacing Voltage Threshold Greater Than 1 Volt (V) at 12 Months|Compare time to first diagnosis in Remote and Control arms|One year post-enrollment|Cohort was subset of full cohort excluding participants with single chamber devices, thus the variance in number analyzed.||Percentage of participants|||Number
718912|NCT00290186|Secondary|The Difference Between Groups in Change in Scores (Post-treatment Minus Pre-treatment) on the Test of Variables of Attention (TOVA): Number of Correct Nonresponses.|One of 4 parts of the TOVA, a computerized continuous performance test that measures attention and impulsivity in visual mode. Measures the number of times a target is correctly not selected (number of times a child correctly refrains from hitting a buzzer) when it appears on a screen. Score ranges from 0-160; higher scores represent greater number of correct nonresponses.|Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)|The TOVA was only administered to patients who were 4-8 years old, not visually impaired, and able to complete a practice test. Analysis included all eligible participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment).||Number of correct nonresponses||95% Confidence Interval|Mean
718913|NCT00290186|Secondary|The Difference Between Groups in Change in Scores (Post-treatment Minus Pre-treatment) on the Test of Variables of Attention (TOVA): Number of Correct Responses.|One of 4 parts of the TOVA, a computerized continuous performance test that measures attention and impulsivity in visual mode. Measures the number of times a target is correctly selected when it appears on a screen. Score ranges from 0-160; higher scores represent greater number of correct responses.|Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)|The TOVA was only administered to patients who were 4-8 years old, not visually impaired, and able to complete a practice test. Analysis included all eligible participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment).||number of correct responses||95% Confidence Interval|Mean
718914|NCT00290186|Secondary|The Difference Between Groups (HBO Minus HBA) in Change in Scores (Post-treatment Minus Pre-treatment) on Pediatric Evaluation of Disability Inventory (PEDI) Caregiver Assistance: Social Function|Primary caregiver-reported (through structured interview) amount of caregiver assistance required by child to complete 5 items of daily activity grouped under social function. Scores are 0 = total assistance, 1 = maximal assistance, 3 = minimal assistance, 4 = supervise/prompt/monitor, 5 = independent. Total scores range from 0-25 and are rescaled to 0-100%. Higher scores indicate greater ability to perform independently.|Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)|Analysis included all participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment).||units on a scale||95% Confidence Interval|Mean
718915|NCT00290186|Secondary|The Difference Between Groups (HBO Minus HBA) in Change in Scores (Post-treatment Minus Pre-treatment) on Pediatric Evaluation of Disability Inventory (PEDI) Caregiver Assistance: Mobility|Primary caregiver-reported (through structured interview) amount of caregiver assistance required by child to complete 7 items of daily activity grouped under mobilityare. Scores are 0 = total assistance, 1 = maximal assistance, 3 = minimal assistance, 4 = supervise/prompt/monitor, 5 = independent. Total scores range from 0-35 and are rescaled to 0-100%. Higher scores indicate greater ability to perform independently.|Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)|Analysis included all participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment).||units on a scale||95% Confidence Interval|Mean
718916|NCT00290186|Secondary|The Difference Between Groups (HBO Minus HBA) in Change in Scores (Post-treatment Minus Pre-treatment) on Pediatric Evaluation of Disability Inventory (PEDI) Caregiver Assistance: Self-care|Primary caregiver-reported (through structured interview) amount of caregiver assistance required by child to complete 8 items of daily activity grouped under self-care. Scores are 0 = total assistance, 1 = maximal assistance, 3 = minimal assistance, 4 = supervise/prompt/monitor, 5 = independent. Total scores range from 0-40 and are rescaled to 0-100%. Higher scores indicate greater ability to perform independently.|Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)|Analysis included all participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment).||units on a scale||95% Confidence Interval|Mean
718917|NCT00290186|Secondary|The Difference Between Groups (HBO Minus HBA) in Change in Scores (Post-treatment Minus Pre-treatment) on Pediatric Evaluation of Disability Inventory (PEDI) Functional Skills: Social Function|Primary caregiver-reported (through structured interview) child capabilities for 65 items of functional skills grouped under social function. Scores are 0 = unable to perform; 1 = capable of performing. Scores range from 0-65 and are rescaled to a 0-100% scale. Higher scores indicate greater abilities.|Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)|Analysis included all participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment).||units on a scale||95% Confidence Interval|Mean
718918|NCT00290186|Secondary|The Difference Between Groups (HBO Minus HBA) in Change in Scores (Post-treatment Minus Pre-treatment) on Pediatric Evaluation of Disability Inventory (PEDI) Functional Skills: Mobility|Primary caregiver-reported (through structured interview) child capabilities for 59 items of functional skills grouped under mobility. Scores are 0 = unable to perform; 1 = capable of performing. Scores range from 0-59 and are rescaled to a 0-100% scale. Higher scores indicate greater abilities.|Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)|Analysis included all participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment).||units on a scale||95% Confidence Interval|Mean
718938|NCT00290329|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], gastrointestinal symptoms and headache. Any = occurrence of the symptom reported irrespective of intensity grade and causal relationship to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.||Subjects|||Number
718919|NCT00290186|Secondary|The Difference Between Groups (HBO Minus HBA) in Change in Scores (Post-treatment Minus Pre-treatment) on Pediatric Evaluation of Disability Inventory (PEDI) Functional Skills: Self-care|Primary caregiver-reported (through structured interview) child capabilities for 73 items of functional skills grouped under self-care. Scores are 0 = unable to perform; 1 = capable of performing. Scores range from 0-73 and are rescaled to a 0-100% scale. Higher scores indicate greater abilities.|Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)|Analysis included all participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment).||units on a scale||95% Confidence Interval|Mean
718920|NCT00290186|Secondary|The Difference Between Groups (HBO Minus HBA) in Change in Score (Post-treatment Minus Pre-treatment) on Gross Motor Function Measure Dimension E|Total percent score on 24 items of GMFM grouped into Dimension E) walking, running, and jumping. Each item scored on 0-3 scale: 0 = does not initiate, 1 = initiates, 2 = partially completes, 3 = completes. Score in Dimension E determined by dividing score obtained by maximum possible score for that dimension (72), and multiplying by 100. Range is 0-100%: the higher the percent score, the greater the functional ability. E) walking, running, and jumping: (score achieved/72)x 100.|Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)|Analysis included all participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment).||units on a scale||95% Confidence Interval|Mean
718921|NCT00290186|Secondary|The Difference Between Groups (HBO Minus HBA) in Change in Score (Post-treatment Minus Pre-treatment) on Gross Motor Function Measure Dimension D|Total percent score on 13 items of GMFM grouped into Dimension D) standing. Each item scored on 0-3 scale: 0 = does not initiate, 1 = initiates, 2 = partially completes, 3 = completes. Score in Dimension D determined by dividing score obtained by maximum possible score for that dimension (39), and multiplying by 100. Range is 0-100%: the higher the percent score, the greater the functional ability. D) standing: (score achieved/51)x100.|Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)|Analysis included all participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment).||units on a scale||95% Confidence Interval|Mean
718922|NCT00290186|Secondary|The Difference Between Groups (HBO Minus HBA) in Change in Score (Post-treatment Minus Pre-treatment) on Gross Motor Function Measure Dimension C|Total percent score on 14 items of GMFM grouped into Dimension C) crawling and kneeling. Each item scored on 0-3 scale: 0 = does not initiate, 1 = initiates, 2 = partially completes, 3 = completes. Score in Dimension C determined by dividing score obtained by maximum possible score for that dimension (42), and multiplying by 100. Range is 0-100%: the higher the percent score, the greater the functional ability. C) crawling and kneeling: (score achieved/42)x100.|Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)|Analysis included all participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment).||units on a scale||95% Confidence Interval|Mean
718923|NCT00290186|Secondary|The Difference Between Groups (HBO Minus HBA) in Change in Score (Post-treatment Minus Pre-treatment) on Gross Motor Function Measure Dimension B|Total percent score on 20 items of GMFM grouped into Dimension B) sitting. Each item scored on 0-3 scale: 0 = does not initiate, 1 = initiates, 2 = partially completes, 3 = completes. Score in Dimension B determined by dividing score obtained by maximum possible score for that dimension (60), and multiplying by 100. Range is 0-100%: the higher the percent score, the greater the functional ability. B) sitting: (score achieved/60)x100.|Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)|Analysis included all participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment).||units on a scale||95% Confidence Interval|Mean
718924|NCT00290186|Secondary|The Difference Between Groups (HBO Minus HBA) in Change in Score (Post-treatment Minus Pre-treatment) on Gross Motor Function Measure Dimension A|Total percent score on 17 items of GMFM grouped into Dimension A) lying and rolling. Each item scored on 0-3 scale: 0 = does not initiate, 1 = initiates, 2 = partially completes, 3 = completes. Score in Dimension A determined by dividing score obtained by maximum possible score for that dimension (51), and multiplying by 100. Range is 0-100%: the higher the percent score, the greater the functional ability. A) lying and rolling: (score achieved/51)x100.|Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)|Analysis included all participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment).||units on a scale||95% Confidence Interval|Mean
718925|NCT00290186|Secondary|The Difference Between Groups (HBO Minus HBA) in Change in Score (Post-treatment Minus Pre-treatment) on Gross Motor Function Measure 66-Item Subscale Score (GMFM-66).|GMFM-66: total percent score on 66-item subscale of GMFM-88: Each item scored on 0-3 scale: 0 = does not initiate, 1 = initiates, 2 = partially completes, 3 = completes. Score determined by dividing score obtained by maximum possible score for the 66 items, and multiplying by 100. Range is 0-100%: the higher the percent score, the greater the functional ability. GMFM-66: [(total score on subset of 66 items/198)x100].|Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)|Analysis included all participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment).||units on a scale||95% Confidence Interval|Mean
718937|NCT00290329|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Days 0-30) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.||Subjects|||Number
718926|NCT00290186|Primary|The Difference Between Groups (HBO Minus HBA) in Change in Score (Post-treatment Minus Pre-treatment) on Gross Motor Function Measure Total Score (GMFM-88).|"GMFM-88: total percent score on 88 items (I) of motor function grouped into 5 dimensions: A) lying and rolling (17 I), B) sitting (20 I), C) crawling and kneeling (14 I), D) standing (13 I), E) walking, running, jumping (24 I). Each item scored on 0-3 scale: 0 = does not initiate, 1 = initiates, 2 = partially completes, 3 = completes. Scores in each dimension determined by dividing score obtained by maximum possible score for that dimension, and multiplying by 100. Range is 0-100% for each: the higher the percent score, the greater the functional ability.
Dimension scores and total GMFM-88 score calculated as:
A) lying and rolling: (score achieved/51)x100 B) sitting: (score achieved/60)x100 C) crawling and kneeling: (score achieved/42)x100 D) standing: (score achieved/39)x100 E) walking, running, and jumping: (score achieved/72)x 100 GMFM-88 = (%A+%B+%C+%D+%E)/number of dimensions GMFM-66: [(total score on subset of 66 items/198)x100]"|Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)|Analysis included all participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment).||units on a scale||95% Confidence Interval|Mean
718927|NCT00290199|Secondary|Induction to Vaginal Delivery Interval|Mean hours from time of induction to vaginal delivery interval.|time from induction to vaginal delivery, up to 24 hours|||hours||Standard Deviation|Mean
718928|NCT00290199|Secondary|Cesarean Rate|The percent of subjects enrolled who had a cesarean at any time for any reason for delivery.|at delivery|||percentage of subjects|||Number
718929|NCT00290199|Secondary|Rate of Delivery (Vaginal or Cesarean)by 24 Hours|The percent of subjects having transcervical foley catheter and percent of subjects not having transcervical foley catheter delivering within 24 hours.|from start of induction to 24 hours post start of induction|||percentage of deliveries|||Number
718930|NCT00290199|Primary|Hours From Placement of Foley or Initiation of Oxytocin to Delivery|The outcome measure is the mean in hours of the time from induction to delivery (up to 24 hours)|Time from induction to delivery|||hours||Standard Deviation|Mean
718931|NCT00290238|Secondary|Total Expenditure Per Day on All Lower Back Pain Related Interventions|Expenditures were assessed by patient report at each visit. Interventions were coded to Current Procedural Terminology (CPT) 2008; costs were derived from Medicare, Managed Care, and Workers’ Comp fees. Costs for providers assume 30 minutes at returning patient rate. Drug costs were coded to a dictionary extrapolated from 2008 market prices.|Baseline, Month 01, Month 02, Month 04, Month 06, Month 08, Month 10, Month 12|Analysis population was intention to treat (ITT).||Dollars||Full Range|Median
718932|NCT00290238|Primary|Change From Baseline in Time-averaged Pain Intensity Visual Analog Scale (VAS) Score|"Visual analog scale (VAS) for pain (100mm line with 0/No pain on the left and 100/Worst pain imaginable on the right). Subjects drew vertical line to indicate pain. Time-averaged method accounts for time between visits by dividing area beneath the score curve by time between first and last available visits."|Time-averaged from the first available observation to the last available observation (12 months for completed subjects)|Analysis population was intention to treat (ITT), excluding subjects who had no follow-up (after the initial 10-week treatment phase) data available.||mm||Standard Error|Least Squares Mean
718933|NCT00290251|Secondary|Quality of Life|The short form-36 (SF-36)and Uterine Fibroid Symptom Quality of Life (UFS-QOL) questionnaires were given before and at treatment end with scales of 0 - 100. SF-36 scales = mental and physical well-being. The UFS subscales are symptom severity, concern, activities, energy and mood, control, self-consciousness, sexual functioning compiled into an overall QOL score. Higher results indicate better QOL on all but symptom severity (higher = worse). The change in scores from baseline to end of treatment was calculated.|3 months (Baseline to end of treatment 1)|All completers received a questionnaire at the end of the three-month study. One woman in the placebo group did not complete the questionnaire.||units on a scale||Standard Error|Mean
718934|NCT00290251|Primary|Shrinkage of Fibroids - Size of Fibroids|The primary outcome, fibroid volume, was calculated by an ellipsoid formula (π/6xd1xd2xd3) using orthogonal three-dimensional measurements taken from pelvic MRI scan. Individual volumes were summed to assess total fibroid volume for each woman, which were log-transformed before analysis. Women with paired MRI results were included in this intent to treat analysis, even if they did not take all study medication. Fibroids were included if they were seen on both studies.The absolute change in cm3 between baseline and end of treatment was calculated and its log was used for statistics and reporting the results in the data table below.|3 months (baseline to end of treatment)|Per protocol, including women with two MRIs regardless of whether they took all study medication||logcm3||Standard Error|Mean
718935|NCT00290290|Primary|The Primary Objective of This Trial is to Compare the Impact of Disinfecting the Skin With Chloraprep vs. Betadine on the Rates of Infection of Clean-contaminated Surgical Wounds.|The primary end point of the study was the occurrence of any surgical-site infection. Diagnosis of surgical-site infection was diagnosed by a blinded reviewer following criteria developed by the Center for Disease Control. The significance of difference between the two study groups in terms of patient characteristics was determined with the use of the Wilcoxon rank-sum test for continuous variables and Fisher's exact test for categorical variables. For efficacy outcomes, we compared the proportions of patients in the two study groups who could be evaluated and who any type of surgical-site infection using Fisher's exact test and calculating the relative risk of infection and 95% confidence intervals. To determine whether the results were consistent across the 6 participating hospitals, a prespecified Breslow-Day test for homogeneity was performed.|during surgery and within the 30 days post surgery|||Percentage of Post Operative Infections|||Number
718936|NCT00290329|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Day 0 to Month 1)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.||Subjects|||Number
718970|NCT00290758|Secondary|Breast Endocrine Environment Measured in Nipple Aspiration Fluid (NAF): Cathepsin D|Mean change in concentration of Cathepsin D measured in nipple aspiration fluid assessed from baseline to 6 month follow up.|6 months - baseline|NAF collection was attempted on all 98 participants and was successful in 46 at both time points. Mean change in Cathespin D concentration available for 44 participants. Analysis performed by menopause and cancer status.||mg/ml||Standard Deviation|Mean
718939|NCT00290329|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Grade 3 irritability = crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = not eating at all. Related = symptom assessed by the investigator as related to the vaccination.|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.||Subjects|||Number
718940|NCT00290329|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Adverse Events|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site (Mencevax ACWY 2-5 YOA Group) and beyond 50 millimeters (mm) of injection site (Mencevax ACWY 6-17 YOA Group and Mencevax ACWY ≥ 18 YOA Group).|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.||Subjects|||Number
718941|NCT00290329|Primary|Number of Subjects With Severe (Grade 3) Unsolicited Adverse Events|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Grade 3 AE = an AE which prevented normal, everyday activities.|During the 31-day (Days 0-30) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.||Subjects|||Number
718942|NCT00290407|Secondary|Blood Specimens Will be Collected to Measure Immunologic Effect||at weeks 4, 8, 12, and at month 6||||||
718943|NCT00290407|Primary|CT Scan to Measure Clinical Effect (Response)|Study terminated, results data not available|3 months after starting treatment, 6 months after starting treatment, and every 6 months (after completing treatment) until disease progression||||||
718944|NCT00290472|Primary|Overall Survival|The overall survival was evaluated using the Kaplan-Meier estimator.|Up to 6 years|||Month||95% Confidence Interval|Median
718945|NCT00290472|Primary|Duration of Response|Duration of response was the time from date of response to date of progression and evaluated among participants with response. According to the 1999 international response criteria as published by Cheson, progression/progressive disease is defined as >=50% increase from nadir in the sum of the products of the greatest diameters of any previously identified abnormal node for PRs or nonresponders, or appearance of any new lesion during or at the end of therapy.|Up to 6 years|||Month||95% Confidence Interval|Median
718946|NCT00290472|Primary|Objective Overall Response Rate|The 1999 international response criteria (http://www.ncbi.nlm.nih.gov/pubmed/10655437#) as published by Cheson was used for the definition of target lesions and CT scans were used for response assessment. CR(complete response)/CRu(unconfirmed complete response) requires disappearance of all target lesions; PR (partial response) requires >=50% decrease in the sum of the products of the greatest diameters; Overall Response (OR)=CR/CRu+PR.|Up to 6 years|||percentage of participants|||Number
718947|NCT00290537|Primary|Number of Participants With Response Following Treatment With 300 mg ZD6474 Daily (Study Part One)|Evaluate the response rate in patients receiving monotherapy with ZD6474 compared to ZD6474 plus carboplatin plus paclitaxel. No formal comparisons could be made and no conclusions drawn because of small numbers in the treatment groups; a result of an inability to fulfil the recruitment target.|Radiologic evaluations performed after weeks 2 and 9 of treatment, then every 2 cycles or as indicated if progressive disease is suspected up to 6 cycles or 18 weeks (1 cycle = 3 weeks).|||Participants|||Number
718948|NCT00290615|Secondary|Overall Survival|Average months of survival of participants after receiving study drug.|From time of treatment until death from any cause, assesed up to 60 months.|||months||95% Confidence Interval|Median
718949|NCT00290615|Other Pre-specified|Effect on Wound Angiogenesis||After study completion||||||
718950|NCT00290615|Other Pre-specified|Effect on Angiogenesis Biomarkers||After study completion||||||
718951|NCT00290615|Secondary|Progression-free Survival|"Disease assessment was performed and recorded according to the Response Evaluation Criteria in Solid Tumors (RECIST v.1.0) Guidelines.
Progressive disease is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
This is the average number of months participants survived without showing progressive disease."|From time of treatment until documented progression or death from any cause, whichever came first, assesed up to 60 months.|||months||95% Confidence Interval|Median
718952|NCT00290615|Secondary|Safety and Tolerability|Number of participants with adverse events|After all participants went off study drug regimine.|||participants with adverse event|||Number
718953|NCT00290615|Primary|Response Rate (Percentage of Participants With Partial or Complete Response)|"Restaging scans occurred every 9 weeks from time of study drug initiation until disease progression.
Disease assessment was performed and recorded according to the Response Evaluation Criteria in Solid Tumors (RECIST v.1.0) Guidelines.
The definitions were:
Complete response (CR)- Disappearance of all target lesions Partial response (PD)- At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Stable disease (SD)- Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Progressive disease (PD) - At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions"|After all subjects were evaluated for restaging which occured every 9 weeks from drug initiation until disease progression, assesed up to 24 months.|All subjects who received restaging scans were analyzed.||percentage of participants with response||95% Confidence Interval|Number
718971|NCT00290758|Secondary|Plasma Concentration of Sex Hormone Binding Globulin (SHBG)||6 months - baseline|Plasma concentration of SHBG was not available for 1 patient in Arm A. Analysis performed by menopause and cancer status.||nmol/L||Standard Deviation|Mean
718954|NCT00290654|Secondary|Percentage of Patients Judging the Cosmetic Outcome as Good or Excellent|The following items will be evaluated by comparing the treated breast with the untreated breast: overall cosmetic result; appearance of the surgical scar; breast size; breast shape; nipple position; and shape of areola. In scoring these items, a 4-point scale will be used, classifying the results into one of the following categories: “0” representing an excellent result; “1” a good result; “2” a fair result; and “3” a poor result.|12 months after treatment|||percentage of participants|||Number
718955|NCT00290654|Secondary|Percentage of Patients Judging the Cosmetic Outcome as Good or Excellent|The following items will be evaluated by comparing the treated breast with the untreated breast: overall cosmetic result; appearance of the surgical scar; breast size; breast shape; nipple position; and shape of areola. In scoring these items, a 4-point scale will be used, classifying the results into one of the following categories: “0” representing an excellent result; “1” a good result; “2” a fair result; and “3” a poor result.|6 months after treatment|||percentage of participants|||Number
718956|NCT00290654|Secondary|Percentage of Physicians Judging the Cosmetic Outcome as Good or Excellent|The following items will be evaluated by comparing the treated breast with the untreated breast: overall cosmetic result; appearance of the surgical scar; breast size; breast shape; nipple position; and shape of areola. In scoring these items, a 4-point scale will be used, classifying the results into one of the following categories: “0” representing an excellent result; “1” a good result; “2” a fair result; and “3” a poor result.|12 months after treatment|||percentage of physicians|||Number
718957|NCT00290654|Secondary|Percentage of Physicians Judging the Cosmetic Outcome as Good or Excellent|The following items will be evaluated by comparing the treated breast with the untreated breast: overall cosmetic result; appearance of the surgical scar; breast size; breast shape; nipple position; and shape of areola. In scoring these items, a 4-point scale will be used, classifying the results into one of the following categories: “0” representing an excellent result; “1” a good result; “2” a fair result; and “3” a poor result.|6 months after treatment|||percentage of physicians|||Number
718958|NCT00290654|Secondary|Percentage of Patients Who Experienced Complications|Complications to be measured include: breast tenderness/pain,reddening of the skin, bruising, formation of blood or fluid under the skin, skin ulceration, infection, discoloration of the skin, development of telangiectasia (spider veins), hardening of the breast tissue, and retraction of the breast tissue.|more than 6 months after treatment, for up to 5 years|||percentage of participants|||Number
718959|NCT00290654|Secondary|Percentage of Patients Who Experienced Complications|Complications to be measured include: breast tenderness/pain,reddening of the skin, bruising, formation of blood or fluid under the skin, skin ulceration, infection, discoloration of the skin, development of telangiectasia (spider veins), hardening of the breast tissue, and retraction of the breast tissue.|within 6 months of treatment|||percentage of participants|||Number
718960|NCT00290654|Primary|Number of Patients With Ipsilateral Breast Tumor Recurrence|Count of patients with early stage breast cancer who developed an ipsilateral breast tumor recurrence (IBTR) and failed after receiving breast-conserving therapy.|5 years after treatment|||participants|||Number
718961|NCT00290654|Primary|Number of Patients With Ipsilateral Breast Tumor Recurrence|Count of patients with early stage breast cancer who developed an ipsilateral breast tumor recurrence (IBTR) and failed after receiving breast-conserving therapy.|1 year after treatment|||participants|||Number
718966|NCT00290732|Secondary|Concentrations of Doxorubicin in Tissue at Definitive Surgery|Due to the limited number of samples and detectable levels, the maximum concentration of doxorubicin in tissue across all the participants in each group is reported.|Day of surgery/biopsy|Participants in whom blood and/or tissue samples were collected at surgery or breast biopsy.||nmol/g|||Number
718967|NCT00290732|Secondary|Concentrations of Doxorubicin in Blood (Plasma) at Definitive Surgery|Due to the limited number of samples and detectable levels, the maximum concentration of doxorubicin in blood (plasma) across all the participants in each group is reported.|Baseline, 4 hrs, day2/24 hrs, day 8, day of surgery/biopsy|Participants in whom blood and/or tissue samples were collected at surgery or breast biopsy.||nM|||Number
718968|NCT00290732|Primary|Maximum Tolerated Dose (MTD)|Maximum tolerated dose (MTD) of administering pegylated liposomal doxorubicin (PLD) into one duct of women with breast cancer awaiting mastectomy. MTD reflects highest dose of drug that did not cause Dose Limiting Toxicity (DLT) in more than 30% of patients.|Until up to 30 days after PLD administration|Participants received intraductal administration of dextrose prior to conventional surgery for breast cancer.||milligrams|||Number
718969|NCT00290758|Secondary|Breast Endocrine Environment Measured in Nipple Aspiration Fluid (NAF): ps2|Mean change in concentration of protein ps2 measured in nipple aspiration fluid assessed from baseline to 6 month follow up.|6 month - baseline|NAF collection was attempted on all 98 participants and was successful in 46 at both time points. Mean change in ps2 concentration available for 44 participants. Analysis performed by menopause and cancer status.||ng/ml||Standard Deviation|Mean
718972|NCT00290758|Secondary|Monitor Drug Delivery by Measuring Plasma Genistein by HPLC|Drug delivery is measured be concentration of genistein in plasma using High Performance Liquid Chromatography (HPLC). Mean change in concentration of plasma genistein is assessed from baseline to 6 month follow up.|6 months - baseline|Analysis performed by menopause and cancer status.||ng/ml||Standard Deviation|Median
718973|NCT00290758|Secondary|Breast Endocrine Environment Measured in Nipple Aspiration Fluid (NAF): Estradiol|Mean change in concentration of estradiol measured in nipple aspiration fluid assessed from baseline to 6 month follow up.|6 months - baseline|NAF collection was attempted on all 98 participants and was successful in 46 at both time points. Mean change in estradiol concentration available for 40 participants. Analysis performed by menopause and cancer status.||pg/ml||Standard Deviation|Mean
718974|NCT00290758|Secondary|Change in Cytomorphologic Assessment of Atypia and Spectral Imaging Analysis of Atypica Features in Epithelial Cells.|"Cytologic atypia evaluation was performed on Papanicolau stained Thin Prep slides using standard criteria, which were also used for spectral spatial imaging. Cell clusters were used to generate image stacks with the Nuance LCTF-based imaging system (CRI Inc). The image data was collected as percent pixels assigned as “atypical”. Mean change in the percent pixels assigned atypical is assessed from baseline to 6 month follow up."|6 months - baseline|Analysis performed by menopause and cancer status.||Percent pixels||Standard Deviation|Mean
718975|NCT00290758|Secondary|Measurement of Change in Concentration of Epidermal Growth Factor (EGF) Found in Nipple Aspirate Fluid (NAF)|Mean change in the concentration of EGF found in nipple aspirate fluid is assessed from baseline to 6 month follow up.|6 months - baseline|NAF collection was attempted on all 98 participants and was successful in 46 at both time points. Mean change in EGF concentration available for 43 participants. Analysis performed by menopause and cancer status.||ng/ml||Standard Deviation|Mean
718976|NCT00290758|Primary|Change in Breast Epithelial Cell Proliferation as Measured by Ki-67 Labeling|Breast epithelial tissue samples are used to measure the expression of the cell proliferation marker Ki-67, by counting the percentage of positive MIB-1 immunostained cells, denoted the Ki-67 labeling index. Mean change in the Ki-67 labeling index is assessed from baseline to 6 month follow up.|6 months - baseline|Participants who had more than 4,000 epithelial cells in rFNA samples at both baseline and 6 month follow up, met the criteria for compliance, and were available for evaluation of Ki-67 labeling index at both time points. Analysis performed by menopause and cancer status.||Ki-67 labeling index||Standard Deviation|Mean
718977|NCT00278863|Secondary|Number of Patients With Adverse Events|Per National Cancer Institute Common Toxicity Criteria Version 2.0, up to 2 years|Up to 2 years|||participants|||Number
718978|NCT00278863|Primary|Response Rate|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR; Progressive disease (PD), >20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD), Insufficient change to qualify for PR or PD
Response rate is defined as the proportion of patients who showed OR."|Up to 2 years|||percentage of participants||95% Confidence Interval|Number
718979|NCT00278876|Secondary|Toxicity Profile|Number of patients who experienced toxicity from study treatment to evaluate the safety and tolerability of adjuvant imatinib|Monitoring of adverse events will be continued for at least 28days following the last dose of study treatment, up to 3 years.|||participants|||Number
718980|NCT00278876|Secondary|2-year Overall Survival Rate||2 years|||percentage of participants|||Number
718981|NCT00278876|Primary|2-year Relapse Free Survival Rate||2 years|||percentage of participants|||Number
718982|NCT00278889|Secondary|QOL: Time to Worsening of FACT Colorectal Cancer Symptom Index(FCSI)|Time when a sustained clinically important deterioration in CCS has been recorded: derived from the FACT-C questionnaires|Randomisation to data cut-off date of November 2007|||Days||Inter-Quartile Range|Median
718983|NCT00278889|Secondary|QOL: Time to Worsening of Clear Cell Sarcoma (CCS)|Time when a sustained clinically important deterioration in CCS has been recorded: derived from the FACT-C questionnaires|Randomisation to data cut-off date of November 2007|||Days||Inter-Quartile Range|Median
718984|NCT00278889|Secondary|QOL: Time to Worsening of Treatment-free Survival (TFS)|Time when a sustained clinically important deterioration in TFS has been recorded: derived from the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) questionnaires|Randomisation to data cut-off date of November 2007|||Days||Inter-Quartile Range|Median
718985|NCT00278889|Secondary|Quality Of Live(QOL) : Time to Worsening of Tissue Oxygen Index (TOI)|Time when a sustained clinically important deterioration in TOI has been recorded: derived from the FACT-C questionnaires|Randomisation to data cut-off date of November 2007|||Days||Inter-Quartile Range|Median
718986|NCT00278889|Secondary|Overall Survival|Number of months from randomisation to the date of death from any cause|Randomisation to data cut-off date of 30 January 2009|||Months||Inter-Quartile Range|Median
718987|NCT00278889|Secondary|Objective Response Rate|"Per RECIST Criteria (V1.0) and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >= ##% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Confirmed Partial Response (PR) or Complete Response (CR) as defined by RECIST."|Randomisation to data cut-off date of November 2007|||Participants|||Number
718988|NCT00278889|Primary|Progression Free Survival|Number of months from randomisation to the earlier date of objective progression or death|Randomisation to data cut-off date of November 2007|||Months||Inter-Quartile Range|Median
718989|NCT00278915|Secondary|Percentage of Patients With Gsα Mutation.|McCune-Albright Syndrome(MAS) is caused by an activating mutation in the gene coding for the stimulatory subunit of the G protein, Gsα. The altered Gsα causes autonomous activation of G-protein stimulated cAMP formation, which in the gonads, results in episodic uncontrolled sex steroid production and subsequent pubertal development. For patients who provided separate specific informed consent, the percentage of patients with a Gsα mutation at screening was assessed by molecular analysis.|Screening assessment (baseline)|||Percentage of participants|||Number
718990|NCT00278915|Secondary|Change in Predicted Adult Height (PAH) From Baseline to Month 12.|Change in PAH from baseline to Month 12/final visit for patients equal to or over 6 years of age.|6 month pre-treatment observation period (result at Screening considered as baseline) followed by 12 month treatment period (on treatment period).|||cm||Standard Deviation|Mean
718991|NCT00278915|Secondary|Change in Pubic Tanner Stage From Baseline to Month 12.|Change in pubic Tanner stage from baseline to Month 12/last visit. Tanner stage (pubic) is a score of range 1-5 where 1=no development and 5=adult pubic hair|6 month pre-treatment observation period (result at Month 0 considered as baseline) followed by 12 month treatment period (on treatment period).|||units on a scale||Full Range|Median
718993|NCT00278915|Secondary|PK: Mean Volume of Distribution (V2/F) .|Total apparent volume of distribution (Vss/F) is the total apparent volume in the body into which Fulvestrant distributes at equilibrium. Vss/F = V1/F + V2/F. V1/F is the volume of the 1st compartment and V2/F is the volume of the second compartment. V2/F only is presented here. The measure of variability presented is the inter-individual error.|Throughout the 12 month treatment period.|||Litres||Standard Error|Mean
718994|NCT00278915|Secondary|PK: Mean Volume of Distribution (V1/F)|Total apparent volume of distribution (Vss/F) is the total apparent volume in the body into which Fulvestrant distributes at equilibrium. Vss/F = V1/F + V2/F. V1/F is the volume of the 1st compartment and V2/F is the volume of the second compartment. V1/F only is presented here. The measure of variability presented is the inter-individual error.|Throughout the 12 month treatment period.|||Litres||Standard Error|Mean
718995|NCT00278915|Secondary|PK: Mean Clearance.|Mean clearance is the average amount of Fulvestrant which is eliminated|Throughout the 12 month treatment period.|||Litres/hour||Standard Deviation|Mean
718996|NCT00278915|Secondary|Hormone Assays: Testosterone.|Hormone assays: testosterone at Screening visit (baseline), Month 12 of the treatment period. Results presented relate to Month 12 of the treatment period..|Month 12 of the treatment period.|||nmol/Litres||Standard Deviation|Mean
718997|NCT00278915|Secondary|Hormone Assays: Follicle-stimulating Hormone (FSH).|Hormone assays: follicle-stimulating hormone (FSH)at Screening visit (baseline), Month 12 of the treatment period. Results presented relate to Month 12 of the treatment period..|Month 12 of the treatment period.|||IU/Litres||Standard Deviation|Mean
718998|NCT00278915|Secondary|Hormone Assays: Luteinizing Hormone (LH).|Hormone assays: Luteinizing hormone (LH) at Screening visit (baseline), Month 12 of the treatment period. Results presented relate to Month 12 of the treatment period.|Month 12 of the treatment period.|||IU/Litres||Standard Deviation|Mean
718999|NCT00278915|Secondary|Hormone Assays: Serum Oestradiol.|Hormone assays: serum oestradiol at Screening visit (baseline), Month 12 of the treatment period. Results presented relate to Month 12 of the treatment period.|Month 12 of the treatment period.|||pmol/Litres||Standard Deviation|Mean
719000|NCT00278915|Secondary|Change in Ovarian Volume From Month 6 to Month 12 by Ultrasound.||Screening visit (baseline), Months 6 and 12 during the treatment period.|||cm^3||Full Range|Median
719001|NCT00278915|Secondary|Change in Ovarian Volume From Baseline to Month 6 by Ultrasound.||Screening visit (baseline), Months 6 and 12 during the treatment period.|||cm^3||Full Range|Median
719002|NCT00278915|Secondary|Change in Ovarian Volume From Baseline to Month 12 by Ultrasound.||Screening visit (baseline), Months 6 and 12 during the treatment period.|||cm^3||Full Range|Median
719003|NCT00278915|Secondary|Change in Uterine Volume From Month 6 to Month 12 by Ultrasound.|Uterine volume was calculated via ultrasound using the formula: 0.5(longitudinal multiplied by anteroposterior multiplied by transverse), if all 3 linear dimensions were recorded. If all 3 linear dimensions were not recorded, uterine volume was not calculated.|Month 6 and Month 12 during the treatment period.|||cm^3||Full Range|Median
719004|NCT00278915|Secondary|Change in Uterine Volume From Baseline to Month 6 by Ultrasound.|Uterine volume was calculated via ultrasound using the formula: 0.5(longitudinal multiplied by anteroposterior multiplied by transverse), if all 3 linear dimensions were recorded. If all 3 linear dimensions were not recorded, uterine volume was not calculated.|Screening visit (baseline) and Month 6 during the treatment period.|||cm^3||Full Range|Median
719005|NCT00278915|Secondary|Change in Uterine Volume From Baseline to Month 12 by Ultrasound.|Uterine volume was calculated via ultrasound using the formula: 0.5(longitudinal multiplied by anteroposterior multiplied by transverse), if all 3 linear dimensions were recorded. If all 3 linear dimensions were not recorded, uterine volume was not calculated.|Screening visit (baseline) and Month 12 during the treatment period.|||cm^3||Full Range|Median
719006|NCT00278915|Secondary|Change in Growth Velocity (Z-Score) Over the Whole 12 Month Trial Period.|Change in growth velocity (Z-Score) from pre-treatment to the full 12 month treatment period. Z-score is [(growth velocity from the previous visit to the current visit – mean) / standard deviation(SD)], where the mean and SD are from the National Center for Health Statistics, Fels study.|6 month pre-treatment observation period (baseline) followed by 12 month treatment period (on treatment period)|||Z-Score||Standard Deviation|Mean
719007|NCT00278915|Secondary|Change in Growth Velocity (Z-Score) Over the Second 6 Month Trial Period.|Change in growth velocity (Z-Score) from pre-treatment to the second 6 months of the treatment period. Z-score is [(growth velocity from the previous visit to the current visit – mean) / standard deviation(SD)], where the mean and SD are from the National Center for Health Statistics, Fels study.|6 month pre-treatment observation period (baseline) followed by 12 month treatment period (on treatment period)|||Z-score||Standard Deviation|Mean
719008|NCT00278915|Secondary|Change in Growth Velocity (Z-Score) Over the First 6 Month Trial Period.|Change from pre-treatment period to the first 6 months of the treatment period. Z-score is [(growth velocity from the previous visit to the current visit – mean) / standard deviation(SD)], where the mean and SD are from the National Center for Health Statistics, Fels study.|6 month pre-treatment observation period (baseline) followed by 6 month treatment period (on treatment period)|||Z-Score||Standard Deviation|Mean
719009|NCT00278915|Secondary|Change in Growth Velocity (Annualised Growth Velocity i.e. cm/y) Over the Whole 12 Month Trial Period.|Change in growth velocity (annualised growth velocity i.e. cm/y) from the pre treatment period to the full 12 month treatment period. Growth velocity for a particular time period was calculated as the increase in height over that time period divided by the length of that time period (expressed in cm/year)|6 month pre-treatment observation period (baseline) followed by 12 month treatment period (on treatment period)|||cm/year||Standard Deviation|Mean
719010|NCT00278915|Secondary|Change in Growth Velocity (Annualised Growth Velocity i.e. cm/y) Over the Second 6 Month Trial Period.|Change in growth velocity (annualised growth velocity i.e. cm/y) from the pre treatment period to the second 6 months of the treatment period. Growth velocity for a particular time period was calculated as the increase in height over that time period divided by the length of that time period (expressed in cm/year)|6 month pre-treatment observation period (baseline) followed by 12 month treatment period (on treatment period)|||cm/year||Standard Deviation|Mean
719150|NCT00294645|Secondary|Percentage of Participants With First Diagnosis of Loss of Ventricular Capture at 12 Months|Compare time to first diagnosis in Remote and Control arms|One year post-enrollment|||Percentage of participants|||Number
719011|NCT00278915|Secondary|Change in Growth Velocity (Annualised Growth Velocity i.e. cm/y) Over the First 6 Month Trial Period.|Change in growth velocity (annualised growth velocity.i.e. cm/y) from the pre treatment period to the first 6 months of the treatment period. Growth velocity for a particular time period was calculated as the increase in height over that time period divided by the length of that time period (expressed in cm/year)|6 month pre-treatment observation period (baseline) followed by 6 month treatment period (on treatment period)|||cm/year||Standard Deviation|Mean
719012|NCT00278915|Secondary|Change in Bone Age Advancement Over the Whole 12 Month Trial Period.|Change in the rate of increase in bone age from pre treatment (based on the 6 month retrospective visit) to the full 12 month treatment period. (Using last value carried forward method for the one patient who withdrew soon after their month 6 bone scan) Bone age advancement for a particular time period was calculated as the increase in bone age over that time period adjusted (ie, normalized) for the length of that time period.|6 month pre-treatment observation period (baseline) followed by 12 month treatment period (on treatment period)|||cm/year||Standard Deviation|Mean
719013|NCT00278915|Secondary|Change in Bone Age Advancement Over the Second 6 Month Trial Period.|Change in the rate of increase in bone age from pre treatment (based on the 6 month retrospective visit) to the second 6 months of the treatment period. Bone age advancement for a particular time period was calculated as the increase in bone age over that time period adjusted (ie, normalized) for the length of that time period.|baseline to second 6 months of the treatment period.|||cm/year||Standard Deviation|Mean
719014|NCT00278915|Secondary|Change in Bone Age Advancement Over the First 6 Month Trial Period.|Change in the rate of increase in bone age from pre treatment (based on the 6 month retrospective visit) to the first 6 months of the treatment period. Bone age advancement for a particular time period was calculated as the increase in bone age over that time period adjusted (ie, normalized) for the length of that time period.|baseline to first 6 months of the treatment period|||cm/year||Standard Deviation|Mean
719015|NCT00278915|Secondary|Percentage of Participants With Baseline Vaginal Bleeding Who Experienced Cessation of Vaginal Bleeding .|Percentage of participants with baseline vaginal bleeding who experienced cessation of vaginal bleeding for the full 12 month treatment period, based on a worst-case approach i.e. missing diary card days counted as bleeding days.|6 month pre-treatment observation period (baseline) followed by 12 month treatment period (on treatment period)|||Percentage of Participants|||Number
719016|NCT00278915|Secondary|Percentage of Participants With Baseline Vaginal Bleeding Who Experienced Cessation of Vaginal Bleeding Over a 6 Month Trial Period.|Percentage of participants with baseline vaginal bleeding who experienced cessation of vaginal bleeding for at least 180 consecutive days during the 12 month treatment period, based on a worst-case approach i.e. missing diary card days counted as bleeding days.|6 month pre-treatment observation period (baseline) followed by 12 month treatment period (on treatment period)|This particular protocolled endpoint does not relate to all patients but only those who had baseline vaginal bleeding - N=23 rather than N=30.||Percentage of Participants|||Number
719017|NCT00278915|Secondary|Percentage of Participants With Baseline Vaginal Bleeding Who Experienced ≥50% Reduction in the Number of Vaginal Bleeding Days|Percentage of participants with baseline vaginal bleeding who experienced ≥50% reduction in the number of vaginal bleeding days during the 12 month treatment period compared to the 6 month baseline period.|6 month pre-treatment observation period (baseline) followed by 12 month treatment period (on treatment period)|Number of participants (23) = number of eligible participants who have had bleeding during the 6 month baseline period||Percentage of Participants|||Number
719018|NCT00278915|Primary|Change in the Frequency of Annualised Days of Vaginal Bleeding|Change in the frequency of annualised days of vaginal bleeding during the 12 month treatment period compared to the 6 month baseline period, based on a worst-case scenario calculation .i.e. missing diary card days counted as bleeding days.|6 month pre-treatment observation period (baseline) followed by 12 month treatment period (on treatment period)|||days per year||Full Range|Median
719019|NCT00278954|Secondary|The Pharmacokinetic (PK) Mean Residence Time (MRT) for Inmuunoglobulin G (IgG)|Blood samples for PK analysis were obtained and analysed at 10 different time points, i.e. -5, 0, 60 minutes (min), 24, 48 hours (hrs), 4, 7, 14, 21 and 28 days, at an infusion visit following 6 months of treatment.|-5, 0, 60 min, 24, 48 hrs, 4, 7, 14, 21 and 28 days|||Days||Standard Deviation|Mean
719020|NCT00278954|Secondary|The Pharmacokinetic (PK) Volume of Distribution (Vz)of Immunoglobulin G (IgG)|Blood samples for PK analysis were obtained and analysed at 10 different time points, i.e. -5, 0, 60 minutes (min), 24, 48 hours (hrs), 4, 7, 14, 21 and 28 days, at an infusion visit following 6 months of treatment.|-5, 0, 60 min, 24, 48 hrs, 4, 7, 14, 21 and 28 days|Only 24 of the 45 evaluable subjects participated in the Pharmacokinetic part of the protocol. No data imputation.||dL/kg||Standard Deviation|Mean
719021|NCT00278954|Secondary|The Pharmacokinetic (PK) Clearance of Immunoglobulin G (IgG)|Blood samples for PK analysis were obtained and analysed at 10 different time points, i.e. -5, 0, 60 minutes (min), 24, 48 hours (hrs), 4, 7, 14, 21 and 28 days, at an infusion visit following 6 months of treatment.|-5, 0, 60 min, 24, 48 hrs, 4, 7, 14, 21 and 28 days|Only 24 of the 45 evaluable subjects participated in the Pharmacokinetic part of the protocol. No data imputation.||mL/day/kg||Standard Deviation|Mean
719022|NCT00278954|Secondary|The Pharmacokinetic (PK) Half-Life of Immunoglobulin G (IgG)|Blood samples for PK analysis were obtained and analysed at 10 different time points, i.e. -5, 0, 60 minutes (min), 24, 48 hours (hrs), 4, 7, 14, 21 and 28 days, at an infusion visit following 6 months of treatment.|-5, 0, 60 minutes (min), 24, 48 hours (hrs), 4, 7, 14, 21 and 28 days|Only 24 of the 45 evaluable subjects participated in the Pharmacokinetic part of the protocol. No data imputation.||Days||Standard Deviation|Mean
719023|NCT00278954|Primary|Number of Serious, Acute, Bacterial Infections (SABIs) Per Subject Per Year in Subjects With Primary Immunodeficiency Disease.|By assessing the number of serious, acute, bacterial infections per subject per year in subjects with Primary Immunodeficiency disease.|12 months|Intent to Treat (ITT).||SABIs/subject/year|||Number
719062|NCT00279201|Secondary|MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions|Abbreviations: AM = morning; BG = blood glucose; PM = evening; PP = postprandial. A postprandial excursion is defined as: 2 hour postmeal plasma glucose-premeal plasma glucose.|Baseline (Maintenance: Week 24), Endpoint (LOCF) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.||mg/dL||Standard Deviation|Mean
719024|NCT00278993|Secondary|Best Objective Tumor Response Rate Based on Response Evaluation Criteria in Solid Tumors (RECIST) Criteria|Based on Response Evaluation Criteria in Solid Tumors (RECIST), consisting of complete response (CR) plus partial response (PR). Defined as the best response from the start of treatment until disease progression or recurrence. Lesions measured by computed tomography (CT) scan and magnetic resonance imaging (MRI). Objective response rate: complete response (CR-disappearance of all lesions)+ partial response (PR-30% decrease in lesion diameter), Progressive Disease (PD-20% increase in lesion diameter), stable disease (SD-neither shrinkage nor increase of lesions).|12 months|Per Protocol Population||Percentage of Participants|||Number
719025|NCT00278993|Secondary|Overall Survival||12 months|Intent to Treat Population||Days||Full Range|Median
719026|NCT00278993|Secondary|Progression Free Survival|From the date study treatment was initiated until the earliest date of the first PSA assessment that determined progressive disease, or the death of death if death occurred without disease progression.|12 months|Per Protocol Population||Days||Full Range|Median
719027|NCT00278993|Secondary|Duration of Prostate Specific Antigen Response Based on Bubley Criteria|Duration of response is the time from >50% decrease from baseline to when there is a 50% decrease in nadir.|12 months.|Per Protocol Population||Days||Full Range|Median
719028|NCT00278993|Primary|Objective Prostate Specific Antigen (PSA) Response Rate Based on Bubley Criteria|Bubley Criteria: Patients must have progressive disease to enter study. For outcomes, PSA response must show at least 50% decrease. Duration of response is the time from >50% decrease from baseline to when there is a 50% decrease in nadir. PSA progressive disease- 25% increase from baseline or increase of 5 ng/mL along with measureable disease Stable disease- decline of less than 50% and not more than 25% increase.|12 months|Per Protocol Population||Percentage of Participants|||Number
719029|NCT00279201|Secondary|ADDENDUM: HbA1c at Specified Visits and Endpoint||Baseline (Addendum: 24 weeks), Weeks 12, 24, Endpoint (24 weeks: Week 48)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: 24 weeks: Week 48.||percent glycosylated hemoglobin||Standard Deviation|Mean
719030|NCT00279201|Secondary|ADDENDUM: Change From Baseline in 1,5-Anhydroglucitol to Week 24||Baseline (addendum: 24 weeks), Endpoint (24 weeks: Week 48)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: 24 weeks: Week 48.||ug/mL||Standard Deviation|Mean
719031|NCT00279201|Secondary|ADDENDUM: Rate of Self-reported Hypoglycemic Episodes|Hypoglycemia = participant feels/person observes, that the participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or a glucose measurement ≤70 mg/dL (≤3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.|Endpoint (Addendum 24 weeks), Overall (mean yearly rate of hypoglycemia during addendum phase|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: 24 weeks: Week 48.||episodes/participant/year||Standard Deviation|Mean
719032|NCT00279201|Secondary|ADDENDUM: Percentage of Participants With Self-reported Hypoglycemic Episodes|Hypoglycemia = any time participant feels/person observes, that the participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or a glucose measurement ≤70 mg/dL (≤3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.|Weeks 6 (Addendum: 30 weeks), 12 (36 weeks), 24 (48 weeks), Endpoint (LOCF)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: 24 weeks: Week 48.||percentage of participants|||Number
719033|NCT00279201|Secondary|ADDENDUM: Insulin Dose||Baseline (Addendum: Week 24), Weeks 1 (25 weeks), 2 (26 weeks), 3 (27 weeks), 4 (28 weeks), 5 (25 weeks), 6 (26 weeks), 8 (32 weeks), 10 (34 weeks), 12 (36 weeks), 24 (48 weeks), Endpoint (LOCF)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: 24 weeks: Week 48.||units/kg/day||Standard Deviation|Mean
719034|NCT00279201|Secondary|ADDENDUM: Body Weight||Baseline (Addendum Week 24), Weeks 6 (30 weeks), 12 (36 weeks), 24 (48 weeks), Endpoint (LOCF)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: 24 weeks: Week 48.||kilograms||Standard Deviation|Mean
719035|NCT00279201|Secondary|ADDENDUM: Incremental Change From Baseline in Body Weight||Baseline (Addendum: Week 24), Weeks 6 (30 Weeks), 12 (36 Weeks), 24 (48 Weeks), Endpoint (LOCF)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: 24 weeks: Week 48.||kilograms||Standard Deviation|Mean
719036|NCT00279201|Secondary|ADDENDUM: 7-point SMPG Profiles|Abbreviations: AM = morning; BG = blood glucose; PM = evening; PP = postprandial. A postprandial excursion is defined as: 2 hour postmeal plasma glucose-premeal plasma glucose.|Endpoint (Addendum: 24 weeks [Week 48])|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: 24 weeks: Week 48.||mg/dL||Standard Deviation|Mean
719037|NCT00279201|Secondary|ADDENDUM: Percentage of Participants With HbA1c < or = 7.0%, HbA1c < 7.0%, and < or = 6.5%||Endpoint (Addendum: 24 weeks [Week 48])|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: 24 weeks: Week 48.||percent of participants|||Number
719038|NCT00279201|Secondary|ADDENDUM: Change in HbA1c From Point of Second Randomization (Addendum Baseline) to Endpoint||Baseline (Addendum: Week 24), Endpoint (24 weeks [Week 48])|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: 24 weeks: Week 48.||percent||Standard Deviation|Mean
719063|NCT00279201|Secondary|MAINTENANCE: HbA1c at Specified Visits and Endpoint||Baseline (Week 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, Endpoint (LOCF) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.||percent glycosylated hemoglobin||Standard Deviation|Mean
719039|NCT00279201|Secondary|MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Mean of Post Meals Blood Glucose and Average of All Blood Glucose|Comparison of baseline mean of post meals blood glucose and average of all blood glucose between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.|Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.||mg/dL||Standard Deviation|Mean
719040|NCT00279201|Secondary|MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Mean of Post Meals Blood Glucose and Average of All Blood Glucose|Comparison of baseline mean of post meals blood glucose and average of all blood glucose between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.|Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.||mg/dL||Standard Deviation|Mean
719041|NCT00279201|Secondary|MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - 1,5 AG|Comparison of baseline 1,5 AG between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.|Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.||ug/ml||Standard Deviation|Mean
719042|NCT00279201|Secondary|MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - 1,5 AG|Comparison of baseline 1,5 AG between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.|Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.||ug/mL||Standard Deviation|Mean
719043|NCT00279201|Secondary|MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Oral Diabetes Medicine at Baseline|Comparison of oral diabetes medication at baseline between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.|Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.||participants|||Number
719044|NCT00279201|Secondary|MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Oral Diabetes Medicine at Baseline|Comparison of oral diabetes medication at baseline between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.|Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.||participants|||Number
719045|NCT00279201|Secondary|MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c Group|Comparison of baseline HbA1c group (<8.5,>=8.5) between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.|Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.||participants|||Number
719046|NCT00279201|Secondary|MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c Group|Comparison of baseline HbA1c group (<8.5,>=8.5) between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.|Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.||participants|||Number
719047|NCT00279201|Secondary|MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c|Comparison of baseline HbA1c between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.|Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.||percent glycosylated hemoglobin||Standard Deviation|Mean
719048|NCT00279201|Secondary|MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c|Comparison of baseline HbA1c between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.|Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.||percent glycosylated hemoglobin||Standard Deviation|Mean
719049|NCT00279201|Secondary|MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes Group|Comparison of duration of diabetes group (<10, 10-<20, >=20 years) at baseline between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.|Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.||participants|||Number
719050|NCT00279201|Secondary|MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes Group|Comparison of duration of diabetes group (<10, 10-<20, >=20 years) at baseline between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.|Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.||participants|||Number
719051|NCT00279201|Secondary|MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes|Comparison of duration of diabetes at baseline between those participants taking lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.|Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.||years||Standard Deviation|Mean
719052|NCT00279201|Secondary|MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes|Comparison of duration of diabetes at baseline between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.|Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.||years||Standard Deviation|Mean
719053|NCT00279201|Secondary|MAINTENANCE: Change From Baseline to Endpoint in HbA1c||Baseline (Week 0), Week 24, Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.||percent glycosylated hemoglobin||Standard Deviation|Mean
719054|NCT00279201|Secondary|MAINTENANCE: Change From Baseline in 1,5-Anhydroglucitol||Baseline (Maintenance: Week 24), Endpoint (LOCF) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.||ug/dL||Standard Deviation|Mean
719055|NCT00279201|Secondary|MAINTENANCE: Rate of Self-reported Hypoglycemic Episodes|Hypoglycemia = participant feels/person observes that the participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or a glucose measurement ≤70 mg/dL (≤3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.|Endpoint (LOCF) (Maintenance) (up to 2.5 years), Overall (incidence of hypoglycemic episodes after baseline [Week 0])|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.||episodes/participant/year||Standard Deviation|Mean
719056|NCT00279201|Secondary|MAINTENANCE: Percentage of Participants With Self-reported Hypoglycemic Episodes|Hypoglycemia = participant feels/person observes that the participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or a glucose measurement ≤70 mg/dL (≤3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.|Endpoint (LOCF) (Maintenance) (up to 2.5 years), Overall (incidence of hypoglycemic episodes after baseline (Week 0)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.||percentage of participants|||Number
719057|NCT00279201|Secondary|MAINTENANCE: Insulin Dose||Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.||units/kg/day||Standard Deviation|Mean
719058|NCT00279201|Secondary|MAINTENANCE: Body Weight||Baseline (Week 0), Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.||kilograms||Standard Deviation|Mean
719059|NCT00279201|Secondary|MAINTENANCE: Incremental Change From Baseline in Body Weight||Baseline (Week 0), Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.||kilograms||Standard Deviation|Mean
719060|NCT00279201|Secondary|MAINTENANCE: Percentage of Participants With HbA1c < or = 7.0%, HbA1c <7.0, and HbA1c < or = 6.5%||Endpoint (LOCF) (Maintenance: up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.||percentage of participants|||Number
719061|NCT00279201|Secondary|MAINTENANCE: Rate of Increase in HbA1c|Rate of increase: HbA1c change/time period (month).|Endpoint (LOCF) (Maintenance: up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.||HbA1c percent increase per month||Standard Deviation|Mean
719064|NCT00279201|Secondary|INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal - Oral Diabetes Medication at Baseline|Comparison of oral diabetes medication at baseline between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).|Endpoint (Initiation: Week 24)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.||participants|||Number
719065|NCT00279201|Secondary|INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Pre Meals Blood Glucose, Post Meals Blood Glucose, Average of All Blood Glucose, and Fasting Blood Glucose|Comparison of pre meals blood glucose, post meals blood glucose, average of all blood glucose, and fasting blood glucose between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).|Endpoint (Initiation: Week 24)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
719066|NCT00279201|Secondary|INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - 1,5 AG|Comparison of 1,5 AG between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).|Endpoint (Initiation: Week 24)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.||micrograms per milliliter (ug/mL)||Standard Deviation|Mean
719067|NCT00279201|Secondary|INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Baseline HbA1c Percentage Group|Comparison of baseline HbA1c percentage group (<8.5,>=8.5) between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).|Endpoint (Initiation: Week 24)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.||participants|||Number
719068|NCT00279201|Secondary|INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - HbA1c|Comparison of baseline HbA1c between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).|Endpoint (Initiation: Week 24)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.||percent glycosylated hemoglobin||Standard Deviation|Mean
719069|NCT00279201|Secondary|INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)|Comparison of HOMA-IR (surrogate markers of insulin resistance calculated from fasting insulin and glucose) at baseline between those participants who met their goal at Week 24 and those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%). HOMA-IR = fasting insulin (milliunits per milliliter) * fasting plasma glucose (millimoles per liter) / 22.5.|Endpoint (Initiation: Week 24)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.||units on a scale||Standard Deviation|Mean
719070|NCT00279201|Secondary|INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Origin|Comparison of origin at baseline between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).|Endpoint (Initiation: Week 24)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.||participants|||Number
719071|NCT00279201|Secondary|INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Age|Comparison of age at baseline between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).|Endpoint (Initiation: Week 24)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.||years||Standard Deviation|Mean
719072|NCT00279201|Secondary|INITIATION: Insulin Dose||Weeks 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, Endpoint (LOCF)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.||units/kg/day||Standard Deviation|Mean
719073|NCT00279201|Secondary|INITIATION: Rate of Self-reported Hypoglycemic Episodes|Hypoglycemia = participant feels/person observes, that participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or glucose measurement ≤70 mg/dL (≤3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.|Endpoint (Initiation: Week 24), Overall (incidence of hypoglycemic episodes after baseline [Week 0])|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.||Episodes/participant/year||Standard Deviation|Mean
719074|NCT00279201|Secondary|INITIATION: Percentage of Participants With Self-reported Hypoglycemic Episodes|Hypoglycemia = any time participant feels/person observes that the participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or a glucose measurement ≤70 mg/dL (≤3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.|Baseline (Initiation), Endpoint (Week 24), Overall (sum of frequencies of hypoglycemic episodes after baseline ([Week 0]).|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.||percentage of participants|||Number
719075|NCT00279201|Secondary|INITIATION: Body Weight||Baseline (Initiation), Weeks 6, 12, 18, 24, Endpoint (LOCF)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.||kilograms||Standard Deviation|Mean
721913|NCT00322621|Secondary|Change From Baseline (Week 0) in Vital Signs: Diastolic Blood Pressure at Week 34 Endpoint||Baseline (Week 0), Week 34|All patients who received either 60 mg or 120 mg duloxetine once daily.||mm Hg||Standard Deviation|Mean
719078|NCT00279201|Secondary|INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions|Abbreviations: AM = morning; BG = blood glucose; PM = evening; PP = postprandial. A postprandial excursion is defined as: 2 hour postmeal plasma glucose-premeal plasma glucose.|Endpoint (LOCF) (Initiation: Week 24)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.||milligrams per 100 Milliliters (mg/dL)||Standard Deviation|Mean
719079|NCT00279201|Secondary|INITIATION: HbA1c||Baseline (Initiation), Week 12, Week 24, Endpoint (LOCF)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.||percent glycosylated hemoglobin||Standard Deviation|Mean
719080|NCT00279201|Secondary|INITIATION: Percentage of Participants With HbA1c < or = 7.0%, HbA1c <7.0%, and HbA1c < or = 6.5% at Endpoint||Endpoint (Initiation: Week 24)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.||percentage of participants|||Number
719081|NCT00279201|Secondary|INITIATION: Change in HbA1c From Baseline to 24 Weeks||Baseline (Initiation) to Endpoint (LOCF, Week 24)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.||percent glycosylated hemoglobin||Standard Deviation|Mean
719082|NCT00279201|Primary|ADDENDUM: 24-Week Endpoint HbA1c|HbA1c at 24-week endpoint in Intensification Addendum of the trial.|Endpoint (Addendum) (24 weeks: Week 48)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: Week 24: 48 weeks.||percent glycosylated hemoglobin||Standard Deviation|Mean
719083|NCT00279201|Primary|MAINTENANCE: Duration of Time HbA1c Maintained at Goal by Initiation Regimen (Insulin Glargine or Lispro Low Mix)|HbA1c goal: HbA1c ≤7.0% or HbA1c >7.0% but increased <0.4% from last HbA1c ≤7.0%|Endpoint (Last Observation Carried Forward [LOCF]) (Maintenance: up to 2.5 years)|Last observation carried forward method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.||months||95% Confidence Interval|Median
719084|NCT00279201|Primary|INITIATION: 24-Week Endpoint Glycosylated Hemoglobin (HbA1c)||Endpoint (Initiation: Week 24)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment in the initiation phase. Initiation baseline: Week 0.||percent glycosylated hemoglobin||Standard Deviation|Mean
719085|NCT00279214|Secondary|Mixed Venous Oxygen Saturation|Cardiovascular performance measures obtained with a pulmonary catheter as assessed by mixed venous oxygen saturation.|Baseline to 24 Hours|Number of per-protocol participants with values at baseline and 24 hours.||percent saturation mixed venous oxygen||Standard Deviation|Mean
719086|NCT00279214|Other Pre-specified|Number of Participants With Bleeding Events|Serious bleeding event resulted in one of following outcomes, or was significant for any reason: initial/ prolonged inpatient hospitalization; life-threatening experience; persistent or significant disability/incapacity; congenital anomaly/birth defect. Intracranial hemorrhage was also considered serious bleeding event.|baseline to 7 days|All enrolled patients||participants|||Number
719087|NCT00279214|Secondary|Endogenous Protein C Level||Baseline to 24 Hours|Number of per-protocol participants with values at baseline, 12, and 24 hours.||percentage of Protein C activity||Standard Deviation|Mean
719088|NCT00279214|Secondary|7 Day All-cause In-hospital Mortality||baseline to 7 days|All enrolled patients||partipants|||Number
719089|NCT00279214|Secondary|Change From Baseline in Creatinine Clearance (CrCl) at 24 Hours|CrCl = (urine creatinine*urine volume)/(plasma creatinine*time period of urine collection). Corrected CrCl = CrCl*1.73/body surface area. Change in CrCl = Endpoint minus baseline.|Baseline and 24 hours|Number of per-protocol participants with values at baseline and 24 hours.||milliliter per minute||Standard Deviation|Mean
719090|NCT00279214|Secondary|Sequential Organ Failure Assessment (SOFA) Score at Baseline and 24 Hours|The presence of 5 organ dysfunctions (cardiovascular, respiratory, renal, hepatic, coagulation) was assessed using a Sequential Organ Failure Assessment (SOFA) score. Each organ has a possible dysfunction score of 0 to 4, for a total SOFA score range of 0 (no organ dysfunction) to 20 (all organs with dysfunction).|Baseline and 24 Hours|Number of per-protocol participants with values at baseline and 24 hours.||units on a scale||Standard Deviation|Mean
719091|NCT00279214|Secondary|Microcirculatory Measures From Sidestream Darkfield (SDF) Microscopy - Small Vessel Microvascular Flow Index (MFI)|Per vessel category (and per quadrant), scored flow as follows: no flow=0, intermediate flow=1, sluggish flow=2, continuous flow=3. The MFI per vessel category calculated with formula (Q1+Q2+Q3+Q4)/4. Scores could range from 0 (sluggish flow) to 3 (continuous flow).|Baseline to 24 Hours|Number of per-protocol participants with values at baseline, 12, and 24 hours.||units on a scale||Standard Deviation|Mean
719092|NCT00279214|Secondary|Lactate Level|Measures of global tissue perfusion and oxygenation were assessed via lactate levels.|Baseline to 6 Hours|Number of per-protocol participants with values at baseline and 6 hours.||millimoles per Liter||Standard Deviation|Mean
719093|NCT00279214|Secondary|Cardiovascular Performance Measures Obtained With a Pulmonary Artery Catheter - Cardiac Index|Cardiac Index = cardiac output divided by body surface area.|Baseline to 24 Hours|Number of per-protocol participants with values at baseline and 24 hours.||liters/minute/meters squared||Standard Deviation|Mean
719094|NCT00279214|Secondary|Mean Arterial Pressure||baseline to 24 hours|Number of per-protocol participants with values at baseline and 24 hours.||mm Hg||Standard Deviation|Mean
719095|NCT00279214|Secondary|Change From Baseline to 96 Hour Endpoint in Cumulative Vasopressor Index (CVI)|CVI is sum of rankings for all vasopressors being used by patient at given time. Based on relative potency and dosing range for each vasopressor, each vasopressor was assigned ranking of 1 (low dosage) to 4 (high dosage). Range of CVI is between 1 and 20.|Baseline, 96 hours|Number of per-protocol participants with values at baseline and 96 hours.||units on a scale||Standard Deviation|Mean
719096|NCT00279214|Primary|Cumulative Vasopressor Index (CVI)|CVI is sum of rankings for all vasopressors being used by patient at given time. Based on relative potency and dosing range for each vasopressor, each vasopressor was assigned ranking of 1 (low dosage) to 4 (high dosage). Range of CVI is between 1 and 20.|baseline to 24 hours|Number of per-protocol participants with values at baseline and 24 hours.||units on a scale||Standard Deviation|Mean
719097|NCT00279305|Primary|Area Under the Stimulated C-peptide Curve Over the First 2 Hours of a 4-hour Mixed Meal Tolerance Test (MMTT) Administered at 1 Year|"The primary outcome is the area under the stimulated C-peptide curve (AUC) based on data collected at time 0 to 2 hours of a 4-hour mixed meal glucose tolerance test (MMTT) conducted at the primary endpoint visit. The timed measurements are done at: 0, 15, 30 60, 90, and 120 minutes.
The calculation for the concentration of c-peptide is a weighted average of the 6 timed measurements of c-peptide in nano-moles/Liter. We try to distinguish this calculation from the AUC by referring to it as the AUC mean and may be expressed algebraically as the AUC/(120 min.); thus, the units are the same as the y-axis."|When all participants complete the 1 year visit|||pmol per mL||95% Confidence Interval|Mean
719098|NCT00284739|Secondary|Duration (in Days) of Percutaneous Drainage.|The total number of days that the drainage catheter was left in place from the time of randomization until the time of catheter removal. The maximum duration of measurement for this outcome was up to 30 days.|Up to 30 days|||days||95% Confidence Interval|Mean
719099|NCT00284739|Secondary|Percentage of Loculated Abscesses Which Completely Resolve With Percutaneous Drainage Alone at the First Follow-up CT Scan Performed 3 Days After Initial Drain Placement|This is the percentage of participants in whom their loculated abscess completely resolve with percutaneous drainage at the time of the first followup CT performed at 3 days after start of the intervention and therefore do NOT require additional surgical intervention.|3 days|||percentage of patients|||Number
719100|NCT00284739|Primary|Percentage of Patients Requiring Surgical Debridement for a Persistent Abscess Within 30 Days Following Initial Drainage||30 days|||participants|||Number
719101|NCT00284856|Secondary|Change From Baseline in Average Morning (AM) PEFR (Peak Expiratory Flow Rate) Over a 6-month Treatment Period|PEFR measurements were performed daily, in the morning before using any medication. The on-treatment AM PEFR was computed by averaging over Period II (treatment period) the AM PEFR recorded daily in the diary, while the baseline AM PEFR was obtained by averaging the AM PEFR across the daily diary entries of the Baseline Period or Period I (placebo run-in period). The change from baseline in average AM PEFR is computed as the difference between mean on-treatment AM PEFR and mean baseline AM PEFR.|Baseline and 6 months|Efficacy analysis was based on the full analysis set (FAS) population which included all participants who received at least one dose of the randomized double-blind study medication and who had at least 7 days of on-treatment data for the specific endpoint.||Liters/minute||Standard Deviation|Mean
719102|NCT00284856|Secondary|Change From Baseline in Mean Daytime Symptom Score Over a 6-month Treatment Period|4 daytime symptoms were evaluated daily on a 7-point scale from 0 (best)- 6 (worst). The on-treatment daytime symptom score was computed by averaging over Period II the mean of the 4 daily symptom scores recorded daily in the diary while the baseline daytime symptom score was obtained by averaging the mean of the 4 daily symptom scores across the daily diary entries of the Baseline period (Period I). The change from baseline in mean daytime symptom score is computed as the difference between the mean on-treatment daytime symptom score & the mean baseline daytime symptom score.|Baseline and 6 months|Efficacy analysis was based on the full analysis set (FAS) population which included all participants who received at least one dose of the randomized double-blind study medication and who had at least 7 days of on-treatment data for the specific endpoint.||Score on a scale||Standard Deviation|Mean
719103|NCT00284856|Primary|Percentage of Asthma-control Days Over the 6-month Treatment Period|An asthma-control day, computed from daily diaries, was any day with no unscheduled visit for asthma care, no use of > than 2 puffs of β-agonist, no use of other asthma rescue medication, and no nocturnal awakening. The percentage of asthma-control days was the number of days with asthma-control divided by the total number of days with non-missing values for this endpoint. The patient diary had questions concerning daytime and nighttime symptoms, morning (AM) and evening (PM) peak expiratory flow rate (PEFR), β-agonist use, asthma attacks and smoking activity.|6 months|Efficacy analysis was based on the full analysis set (FAS) population which included all participants who had at least 7 days of on-treatment data for the specific endpoint. Thirty three patients were excluded from the FAS (13 on montelukast, 7 on fluticasone and 13 on placebo). One participant in the placebo group did not take study medication.||Percentage of days||Standard Deviation|Mean
719104|NCT00284934|Secondary|Number of Participants With Graft and Patient Survivals at 6 Months|Graft survival was defined as the number of patients with no graft loss. The allograft was presumed lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis. If the patient went through a graft nephrectomy, then the day of nephrectomy was the day of graft loss. Patient survival was defined as the number of patients alive with or without a functioning graft.|6 months|Intent-to-treat (ITT) population was defined as all patients who were randomized and treated with study medication and had at least one post-treatment efficacy assessment.||Participants|||Number
719105|NCT00284934|Secondary|Number of Participants With Treatment Failure Parameters (Biopsy-Proven Acute Rejection (BPAR), Graft Loss, Death, or Loss to Follow-up) at 6 Months|A biopsy-proven acute rejection (BPAR) is defined as a biopsy graded IA, IB, IIA, IIB, or III based on the Banff 1997 classification.The allograft was presumed lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis. If the patient went through a graft nephrectomy, then the day of nephrectomy was the day of graft loss.|6 months|Intent-to-treat (ITT) population was defined as all patients who were randomized and treated with study medication and had at least one post-treatment efficacy assessment.||Participants|||Number
719106|NCT00284934|Secondary|Renal Function at 3 Months Assessed by Change in Estimated Glomerular Filtration Rate (eGFR)|Change in estimated glomerular filtration rate from baseline to Month 3 calculated by using abbreviated MDRD formula. Modification of Diet in Renal Disease (MDRD) formula is: GFR [mL/min/1.73m^2] = 186.3*(C^-1.154)*(A^-0.203)*G*R where -C is the serum concentration of creatinine [mg/dL], -A is patient age at sample collection date [years], -G=0.742 when gender is female, otherwise G=1, -R=1.21 when race is black, otherwise R=1.|Baseline and 3 months|Intent-to-treat (ITT) population was defined as all patients who were randomized and treated with study medication and had at least one post-treatment efficacy assessment.||mL/min/1.73m^2||Standard Deviation|Mean
719133|NCT00291018|Secondary|Visual Analog Scale (VAS) Arm Pain Frequency|The visual analogue scale (VAS) is commonly used questionnaire and is presented as a 100mm horizontal line. A patient represents their personal opinion regarding their health by adding a vertical line on the VAS horizontal line between the extremes of “None of the Time [Arm] Pain” at 0mm and “All of the Time [Arm] Pain” at 100mm.|84 Months|Subjects who completed the VAS Arm Pain Frequency Questionnaire at 84 Months||% of Subjects|||Number
719107|NCT00284934|Primary|Renal Function Assessed by Change in Estimated Glomerular Filtration Rate(eGFR)|Change in estimated glomerular filtration rate from baseline to Month 6 calculated by using abbreviated Modification of Diet in Renal Disease (MDRD) formula. Modification of Diet in Renal Disease (MDRD) formula is: GFR [mL/min/1.73m^2] = 186.3*(C^-1.154)*(A^-0.203)*G*R where -C is the serum concentration of creatinine [mg/dL], -A is patient age at sample collection date [years], -G=0.742 when gender is female, otherwise G=1, -R=1.21 when race is black, otherwise R=1.|Baseline and Month 6|Intent-to-treat (ITT) population was defined as all patients who were randomized and treated with study medication and had at least one post-treatment efficacy assessment.||mL/min/1.73m^2||Standard Deviation|Mean
719108|NCT00285012|Secondary|Change From Baseline in Body Weight|Change from baseline calculated as mean at observation minus baseline value; body weight measured in kilograms (kg).|Baseline, Week 52|Subjects with change in body weight in the All subjects population||kg||Standard Deviation|Mean
719109|NCT00285012|Secondary|Change From Baseline in Inflammatory Biomarkers: C-Reactive Protein (CRP) and Fibrinogen Antigen|Change from baseline in CRP and Fibrinogen antigen (blood markers of inflammation) calculated as mean at observation minus baseline value; measured as milligrams per deciliter (mg/dl).|Baseline, Week 12, Week 52|All subjects population; (n) = number of subjects with analyzable data at observation for varenicline and placebo, respectively.||mg/dl||Standard Deviation|Mean
719110|NCT00285012|Secondary|Number of Cigarettes Smoked Daily During First 3 Weeks of the 12-Week Treatment Period|Number of cigarettes smoked daily collected during the first 3 weeks of study after randomization using patient smoking diaries.|Day 1 through Day 21|All subjects population; (n) = number of subjects who smoked at least 1 cigarette at the given day for varenicline and placebo, respectively.||cigarettes per day||Standard Deviation|Mean
719111|NCT00285012|Secondary|Change From Baseline in Clinical COPD Questionnaire (CCQ)|Change from baseline: mean at observation minus baseline value. Subject-administered 10-item instrument to systematically assess COPD symptoms (items 1, 2, 5, and 6), functional states (items 7, 8, 9, and 10) and mental states (items 3 and 4); For each domain score = sum of items divided by the number of items; total score = sum of scores divided by 10; range from 0 (very good health) to 6 (extremely poor health). Assessed at each visit based on subject's experience during the week prior to visit.|Baseline, Week, 12, Week 24, Week 52|All subjects; (n) = subjects with analyzable data at observation for varenicline and placebo, respectively.||scores on scale||Standard Deviation|Mean
719112|NCT00285012|Secondary|Change From Baseline in Pre-bronchodilator and Post-bronchodilator Forced Expiratory Volume in First Second (FEV1)|Change from baseline in mean FEV1 (forced expiratory volume in the first second of forced exhalation) measured in millimeters (ml) as mean at observation minus baseline value. Directly after pre-bronchodilator measurement, subject inhaled albuterol or salbutamol delivered by metered-dose inhaler (MDI); post-bronchodilator lung function repeated 30 to 45 minutes following administration of albuterol or salbutamol.|Baseline, Week 12, Week 52|All subjects population; (n) = subjects with analyzable data at observation for varenicline and placebo, respectively. Missing data imputed by carrying the last observation forward (LOCF), including baseline values.||ml||Standard Deviation|Mean
719113|NCT00285012|Secondary|Number of Subjects With 4-Week Point Prevalence of Abstinence|Number of subjects at Week 52 visit reporting no smoking and no use of other tobacco products in the last 4 weeks and with end-expiratory exhaled CO measurement less than or equal to 10 ppm.|Week 52|All subjects population||particpants|||Number
719114|NCT00285012|Secondary|Number of Subjects With 7-Day Point Prevalence of Abstinence|Number of subjects at given visit (Week 12, Week 24, Week 52) or telephone contact, reported no smoking and no use of other nicotine-containing products (treatment phase) or tobacco products (non-treatment phase) in the last 7 days and with end-expiratory exhaled CO measurement less than or equal to 10 ppm. CO confirmed in-clinic visit.|Week 12, Week 24, Week 52|All subjects population||participants|||Number
719115|NCT00285012|Secondary|Number of Subjects With Long Term Quit Rate (LTQR)|"Number of subjects who were responders for the primary endpoint (4-week CQR for Weeks 9 through 12) and who had no more than 6 cumulative days of smoking from Week 12 through the given visit (Week 24 and Week 52).
CO confirmed in-clinic visit."|Week 24, Week 52|All subjects population||participants|||Number
719116|NCT00285012|Secondary|Number of Subjects With Continuous Abstinence (CA)|Number of subjects who reported no smoking and no use of other nicotine-containing products (treatment phase = through week 12) or tobacco products (non-treatment phase = after treatment phase; follow up through week 52) at each contact (on the NUI) and with end-expiratory exhaled CO measurement less than or equal to 10 ppm from week 9 through week 24 and week 52. CO confirmed in-clinic visit.|Week 9 through Week 24 and Week 52|All subjects population||participants|||Number
719117|NCT00285012|Primary|Number of Subjects With Four Week Continuous Quit Rate (CQR)|Number of subjects who reported no smoking and no use of other nicotine-containing products since the last study visit (on the Nicotine Use Inventory [NUI]) and with end-expiratory exhaled carbon monoxide (CO) measurement less than or equal to 10 parts per million (ppm) for weeks 9 through 12 (inclusive).|Week 9 through Week 12|All subjects population: received at least 1 dose, including partial doses, of randomized study drug.||participants|||Number
719118|NCT00290771|Secondary|Number of Patients With at Least 1 Adverse Event|An adverse event (AE) is any undesirable sign, symptom, or medical condition occurring after starting study drug even if the event is not considered to be related to study drug. Study drug refers to imatinib or hydroxyurea. The study treatment is the combination of these two study drugs.|Baseline to end of study (Month 24)|Safety population: All patients who received at least 1 dose of either of the 2 study drugs and who had at least 1 post-baseline safety assessment.||Participants|||Number
719119|NCT00290771|Secondary|Percentage of Patients Surviving at Months 6, 12, and 24|Patients not known to have died were censored at the time of last survival follow-up.|Months 6, 12, and 24|Intent-to-treat (ITT) population: All patients who received at least 1 dose of any of the 2 study drugs.||Percentage of participants||95% Confidence Interval|Number
719134|NCT00291018|Secondary|Visual Analog Scale (VAS) Arm Pain Intensity|The visual analogue scale (VAS) is commonly used questionnaire and is presented as a 100mm horizontal line. A patient represents their personal opinion regarding their health by adding a vertical line on the VAS horizontal line between the extremes of “No [Arm] Pain” at 0mm and “Worst [Arm] Pain Possible” at 100mm.|84 Months|Subjects who completed the VAS Arm Pain Intensity Questionnaire at 84 Months||% of Subjects|||Number
719120|NCT00290771|Secondary|Percentage of Patients With Progression-free Survival at Months 6 and 12|Progression-free survival (PFS) was defined as the time from the start of treatment to the date of the first documented disease progression (PD) or death due to any cause. (PD) was defined as ≥ 25% increase in size of the sum of the products of the largest perpendicular diameters of the target tumors compared to the smallest value recorded at or after baseline. If a patient had not progressed or died, progression-free survival was censored at the time of the last overall response assessment.|Months 6 and 12|Intent-to-treat (ITT) population: All patients who received at least 1 dose of any of the 2 study drugs.||Percentage of participants||95% Confidence Interval|Number
719121|NCT00290771|Secondary|Percentage of Patients Who Had Clinical Benefit|Patients who had clinical benefit were patients with a best response of complete response (CR), partial response (PR), or stable disease (SD) lasting for more than 6 months from the start of treatment until the first documented disease progression (PD) or death from any cause. (PD) was defined as ≥ 25% increase in size of the sum of the products of the largest perpendicular diameters of the target tumors compared to the smallest value recorded at or after baseline. SD was defined as insufficient tumor shrinkage to qualify for PR or CR and no increase in lesions which would qualify as PD.|Baseline to end of study (Month 24)|Intent-to-treat (ITT) population: All patients who received at least 1 dose of any of the 2 study drugs.||Percentage of participants||95% Confidence Interval|Number
719122|NCT00290771|Secondary|Duration of Objective Overall Response (OOR)|Duration of OOR only included patients whose best overall response was complete response (CR) or partial response (PR). The start date was the date of the first documented response (CR or PR); the end date was the date of the first documented disease progression (PD) or death from any cause. (PD) was defined as ≥ 25% increase in size of the sum of the products of the largest perpendicular diameters of the target tumors compared to the smallest value recorded at or after baseline. If a patient had not progressed or died, the duration of OOR was censored at the time of the last OOR assessment.|Baseline to end of study (Month 24)|Intent-to-treat (ITT) population: All patients who received at least 1 dose of any of the 2 study drugs.||Weeks||95% Confidence Interval|Median
719123|NCT00290771|Primary|Percentage of Patients With an Objective Overall Response (OOR)|Patients with an OOR were those whose best response to treatment was a complete response (CR) or a partial response (PR) assessed with magnetic resonance imaging. A patient had a CR if the target tumors disappeared. A patient had a PR if there was a ≥ 50% reduction in the sum of the products of the largest perpendicular diameters of the target tumors compared to the baseline value. A best response of CR required at least 2 determinations of CR at least 4 weeks apart. A best response of PR required at least 2 determinations of PR or better at least 4 weeks apart (and not qualifying for CR).|Baseline to end of study (Month 24)|Intent-to-treat (ITT) population: All patients who received at least 1 dose of any of the 2 study drugs.||Percentage of participants||95% Confidence Interval|Number
719124|NCT00290810|Secondary|Time to Progression|"Progression is defined as one of the following:
A ≥50% increase in the sum of the products of at least 2 lymph nodes on 2 consecutive determinations 2 weeks apart (at least one node must be ≥2 cm) or the appearance of new palpable lymph nodes, or
A ≥50% increase in the size of the liver and/or spleen as determined by measurement below the respective costal margin or the appearance of hepatomegaly or splenomegaly which was not previously present, or
The transformation to a more aggressive histology (e.g. Richter’s transformation), or
A ≥ 50% increase in the absolute number of circulating lymphocytes.
The Kaplan-Meier method will be used to estimate time to progression."|From the date of registration to the date of the event (i.e., death or disease progression) or the date of last follow-up, up to 5 years|||months||95% Confidence Interval|Median
719125|NCT00290810|Secondary|Overall Survival|The Kaplan-Meier method will be used to estimate distributions in the B-CLL population.|From the date of registration to the date of the event (i.e., death or the date of last follow-up), up to 5 years.|||months||95% Confidence Interval|Median
719126|NCT00290810|Secondary|Toxicity Associated With This Regimen in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL).|As per NCI Common Toxicity Criteria for Adverse Effects (CTCAE) Version 3.0, the term toxicity is defined as adverse events that are classified as either possibly, probably, or definitely related to study treatment. The number of participants experiencing grade 3 or higher toxicity will be reported here.|From the date of registration to the to the date of last treatment evaluation, median number of days on treatment was 56 days.|All 12 participants treated will be used to analyze this endpoint.||participants|||Number
719127|NCT00290810|Primary|Number of Patients With Confirmed Objective Status of Complete Response (CR), Complete Clinical Response (CCR), Nodular Partial Response (nPR), or Partial Response (PR).|"The NCI Working Group criteria will be used to assess response to therapy. A confirmed response is defined as a response documented on 2 consecutive evaluations at least 4 weeks apart.
Complete Response:
No lymphadenopathy
No hepatomegaly or splenomegaly
Absense of constitutional symptoms
Polymorphonuclear leukocytes ≥ 1500/ul
Platelets > 100,000/ul
Hemoglobin > 11.0 gm/dl
Peripheral blood lymphocytes ≤ 4000/uL.
Confirmation by Marrow Aspirate and biopsy.
Complete Clinical Response:
-CR without bone marrow biopsy confirmation.
Nodular Partial Response:
-CR with the presence of residual clonal nodules.
Partial Response requires:
≥ 50% decrease in peripheral blood lymphocyte count
≥ 50% reduction in lymphadenopathy
≥ 50% reduction in size of liver and/or spleen
1 or more of the following:
Polymorphonuclear leukocytes ≥ 1500/ul
Platelets >100,000/ul
Hemoglobin >11.0 gm/dl"|Up to 5 years|All 12 patients are used in this analysis||participants|||Number
719128|NCT00290888|Secondary|Upper Extremity Strength Grading||24 months||||||
719129|NCT00290888|Secondary|Shoulder Range of Motion||24 months||||||
719130|NCT00290888|Primary|American Shoulder and Elbow Surgeons Standardized Form for the Assessment of the Shoulder (ASES)|Calculated as a percentage with an increase in score reflecting an improvement in outcome.|24 months|||percentage of total score||Standard Deviation|Mean
719131|NCT00290888|Primary|Western Ontario Rotator Cuff Index (WORC)|Calculated as percentage with an increase in score indicating an improvement in outcome.|24 months|||percentage of total score||Standard Deviation|Mean
719132|NCT00291018|Secondary|Surgery Again|% of subjects who would opt to have the surgery again if given the choice at 84 months.|84 Months|Subjects who completed this questionnaire at 84 months||% of Subjects|||Number
719147|NCT00294645|Secondary|Percentage of Participants With First Diagnosis of Change in Atrial Lead Impedance at 12 Months|Compare time to first diagnosis in Control and Remote arms|One year post-enrollment|Cohort was subset of full cohort excluding participants with single chamber devices, thus the variance in number analyzed.||Percentage of participants|||Number
719135|NCT00291018|Secondary|Visual Analog Scale (VAS) Neck Pain Frequency|The visual analogue scale (VAS) is commonly used questionnaire and is presented as a 100mm horizontal line. A patient represents their personal opinion regarding their health by adding a vertical line on the VAS horizontal line between the extremes of “None of the Time [Neck] Pain” at 0mm and “All of the Time [Neck] Pain” at 100mm.|84 Months|Subjects who completed the VAS Neck Pain Frequency Questionnaire at 84 Months||% of Subjects|||Number
719136|NCT00291018|Secondary|Visual Analog Scale (VAS) Neck Pain Intensity|The visual analogue scale (VAS) is commonly used questionnaire and is presented as a 100mm horizontal line. A patient represents their personal opinion regarding their health by adding a vertical line on the VAS horizontal line between the extremes of “No [Neck] Pain” at 0mm and “Worst [Neck] Pain Possible” at 100mm.|84 Months|Subjects who completed the VAS Neck Pain Intensity Questionnaire at 84 Months||% of Subjects|||Number
719137|NCT00291018|Secondary|Visual Analog Scale (VAS) Satisfaction|The visual analogue scale (VAS) is commonly used questionnaire and is presented as a 100mm horizontal line. A patient represents their personal opinion regarding their health by adding a vertical line on the VAS horizontal line between the extremes of “No Satisfaction [with the surgery/outcome]” at 0mm and “Completely Satisfied [with the surgery/outcome]” at 100mm.|84 Months|Subjects who completed the VAS Satisfaction Questionnaire at 84 Months||mm||Standard Deviation|Mean
719138|NCT00291018|Secondary|SF-36 Mental Composite Score (MCS)|"The Short Form-36 (SF-36) is a 36 item questionnaire which measures Quality of Life (QoL) across eight domains, which are both physically and emotionally based. The eight domains that the SF-36 measures are as follows: physical functioning; role limitations due to physical health; role limitations due to emotional problems; energy/fatigue; emotional well-being; social functioning; pain; general health. A single item is also included that identifies perceived change in health, making the SF-36 a useful indicator for change in QoL over time and treatment.
It can take patients at least half an hour to complete the SF-36.
The Mental Composite Score (MCS) specifically looks at the mean average of all of the mental or emotional relevant questions."|84 Months|Subjects who completed the SF-36 questionnaire at 84 Months||% of Subjects|||Number
719139|NCT00291018|Secondary|SF-36 Physical Composite Score (PCS)|"The Short Form-36 (SF-36) is a 36 item questionnaire which measures Quality of Life (QoL) across eight domains, which are both physically and emotionally based. The eight domains that the SF-36 measures are as follows: physical functioning; role limitations due to physical health; role limitations due to emotional problems; energy/fatigue; emotional well-being; social functioning; pain; general health. A single item is also included that identifies perceived change in health, making the SF-36 a useful indicator for change in QoL over time and treatment.
It can take patients at least half an hour to complete the SF-36.
The Physical Composite Score (PCS) specifically looks at the mean average of all of the physically relevant questions."|84 Months|Subjects who completed the SF-36 questionnaire at 84 Months||% of Subjects|||Number
719140|NCT00291018|Secondary|NDI|"The NDI is a patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation and is the most commonly used self-report measure for neck pain.
The NDI can be scored as a raw score or doubled and expressed as a percent. Each section is scored on a 0-5 rating scale (0 = 'No pain' and 5 = 'Worst imaginable pain'). The points can be summed to a total score. The test can be interpreted as a raw score, with a maximum score of 50, or as a percentage: 0 points or 0% means : no activity limitations, 50 points or 100% means complete activity limitation.
Mean duration of the test is 3-8 minutes and the results can be interpreted as (see below):
0-4 points (0-8%) no disability,
5-14 points (10–28%) mild disability,
15-24 points (30-48% ) moderate disability,
25-34 points (50- 64%) severe disability,
35-50 points (70-100%) complete disability."|84 months|Completed the NDI Questionnaire at 84 Months||% of Subjects|||Number
719141|NCT00291018|Secondary|Neurologic Success|% of subjects who were a neurological success (i.e. the patient's neurologic parameters, i.e. motor, sensory, and reflexes are maintained or improved as compared to preoperative baseline value)|84 months|"Subjects who were per protocol excluding device failures"||% of Subjects|||Number
719142|NCT00291018|Primary|Overall Success|"Sponsor Definition of Overall Success:
Subject's NDI score improved by at least 20% over preoperative baseline value
Subject's neurologic parameters, i.e. motor, sensory, and reflexes were maintained or improved as compared to preoperative baseline value
No removals, revisions, re-operations, or additional fixation were required to modify any implant
No adverse events occurred which were related to the treatment, ProDisc-C or its implantation or ACDF surgery or its associated implants or graft material"|84 Months|Subjects with data at 84 months||% of Subjects|||Number
719143|NCT00294554|Primary|CIBIC-Plus Score|CIBIC-Plus is based upon clinicians’ observations of change in the patient’s cognitive, functional, and behavioral performance since the beginning of a trial. It relies on both direct examination of the patient and interview of informants. It takes into account a subject’s overall function in the cognitive, behavioral and functional activity domains. Scoring is based on an interview with the caregiver and examination of the patient by an independent evaluator, without consulting other information such as cognitive test results. It requires the assessor to consider a number of cognitive, functional, and behavioral areas prior to providing an overall “global” assessment of clinical change. 7-point categorical scale that provides a single global rating of change from baseline.A score of 1 indicates marked improvement;and a score of 7, marked worsening.|24 weeks|||Participants|||Count of Participants
719144|NCT00294554|Primary|Change in Dementia Rating Scale (DRS) Memory Subscore|The DRS is comprised of: Attention (ATT, 8 items); Initiation-Perseveration (I-P, 11 items); Construction (CONST, 6 items); Conceptualization (CONCEPT, 6 items); and Memory (MEM, 5 items). For this study, only the memory subscore was used, with score possibilities ranging from 0-5, with 5 meaning memory was perfect, 0 being no ability to recall. A negative score indicates a decrease in memory from baseline to 24 weeks.|change from baseline to 24 weeks|||units on a scale||95% Confidence Interval|Mean
719145|NCT00294645|Secondary|Percentage of Participants With First Diagnosis of Elective Replacement Indicator/Battery End of Life (ERI/EOL) at 12 Months|Compare time to first diagnosis in Control and Remote arms|One year post-enrollment|||Percentage of participants|||Number
719146|NCT00294645|Secondary|Percentage of Participants With First Diagnosis of Change in Ventricular Lead Impedance at 12 Months|Compare time to first diagnosis in Control and Remote arms|One year post-enrollment|||Percentage of participants|||Number
719154|NCT00294645|Secondary|Percentage of Participants With First Diagnosis of Atrial Tachycardia/Atrial Fibrillation Greater Than 48 Hours at 12 Months|Compare time to diagnosis in Control and Remote arms|One year post-enrollment|Cohort was subset of full cohort excluding participants with single chamber devices, thus the variance in number analyzed vs other endpoint analyses.||Percentage of participants|||Number
719155|NCT00294645|Secondary|Percentage of Participants With First Diagnosis of Sensed Ventricular Rate Greater Than 100 Beats Per Minute (BPM) During Atrial Tachycardia/Atrial Fibrillation at 12 Months|Compare time to diagnosis in Control and Remote arms|One year post-enrollment|||Percentage of participants|||Number
719156|NCT00294645|Secondary|Percentage of Participants With First Diagnosis of New Onset Atrial Tachycardia/Atrial Fibrillation (AT/AF) at 12 Months|Compare time to first diagnosis in Remote and Control arms|One year post-enrollment|Only participants without a history of Atrial Tachycardia/Atrial Fibrillation were included in analysis of this objective.||Percentage of participants|||Number
719157|NCT00294645|Secondary|Proportion of Actions Taken in Response to the Diagnosis of Clinically Actionable Events|Actions categories include: Referral, Office Visit, Medication (Med) Change, Hospitalization, Emergency Room (ER) Visit, Device Reprogrammed, System Modification, Increase Monitoring, Other|One year post-enrollment|||Total number actions/total number CAEs|||Number
719158|NCT00294645|Primary|Percentage of Participants With First Diagnosis of Clinically Actionable Events (CAE) at 12 Months|Clinically Actionable Events (CAE) are 12 events that were identified based on their relation to other comorbidities that may increase the risk of a serious cardiac event. The CAEs consist of several arrhythmias and device performance parameters such as: Atrial Tachycardia/Atrial Fibrillation (AT/AF) and loss of capture.|One year post-enrollment|||Percentage of participants|||Number
719159|NCT00294658|Secondary|Treatment Associated Symptoms (TAS)|Treatment associated symptoms measured myasthenia gravis symptoms such as back pain and/or bruises. Report number of participant with at least one treatment associated symptoms by each visit.|Month 0, 1, 2, 3, 4 then every 3 months through Month 36|Patients were in and out by visit||Participants|||Count of Participants
719160|NCT00294658|Secondary|Treatment Associated Complications (TAC)|Treatment associated complications measured complications occurred by myasthenia gravis patients. Report number of participant with at least one complications by each visit.|Month 0, 1, 2, 3, 4 then every 3 months through Month 36|Participants were in and out by each visit.||Participants|||Count of Participants
719161|NCT00294658|Secondary|Short Form-36 Standardized Mental Component|Range from 0 to 100, the higher the mental component value, the better the mental health.|Month 0, Month 12, Month 24 and Month 36|Participants were in and out by visit.||units on a scale||Full Range|Median
719162|NCT00294658|Secondary|Short Form-36 Standardized Physical Component|Range from 0 to 100, the higher the physical component value, the better the mental health.|Month 0, Month 12, Month 24 and Month 36|Participants were in and out by visit.||units on a scale||Full Range|Median
719163|NCT00294658|Secondary|Cumulative Days in Hospital for Myasthenia Gravis Exacerbation|Number of patients with MG exacerbation: Thymectomy plus prednisone=6 (out of 66); Prednisone alone=22 (out of 60)|baseline to 3 years|||days||Standard Deviation|Mean
719164|NCT00294658|Secondary|Cumulative Days in Hospital for Myasthenia Gravis Exacerbation|Number of patients with MG exacerbation: Thymectomy plus prednisone=6 (out of 66); Prednisone alone=17 (out of 60)|baseline to 2 years|||days||Standard Deviation|Mean
719165|NCT00294658|Secondary|Minimal Manifestation (MM) Status at Month 12, 24 and 36|Number of participants who were in minimal manifestation status at month 12, 24 and 36.|Month 12, 24 and 36|Number analyzed: Thymectomy plus prednisone: n=61 (Month 12), 59 (Month 24) , and 58 (Month 36); Prednisone alone n=54 (Month 12), 53 (Month 24), and 51 (Month 36)||participants|||Number
719166|NCT00294658|Secondary|Intravenous Immunoglobulin Use||baseline to 3 years|||participants|||Number
719167|NCT00294658|Secondary|Plasma Exchange Use||baseline to 3 years|||participants|||Number
719168|NCT00294658|Secondary|Azathioprine Use||baseline to 3 years|||participants|||Number
719169|NCT00294658|Secondary|Time-Weighted Average MG Activity of Daily Living (MG-ADL) at Month 12, 24, and 36|MG Activity of Daily Living total scores range from 0 to 24 by visit, with the lower scores indicating better daily living quality of life.|Month 12, 24, and 36|Participants were in and out at month 12, 24 and 36 visit.||units on a scale||Standard Deviation|Mean
719170|NCT00294658|Secondary|Time-Weighted Average MG Activity of Daily Living (MG-ADL)|MG Activity of Daily Living total scores range from 0 to 24, with the lower scores indicating better daily living quality of life.|baseline, month 4, 6 and every 3 months through 36 months|Five participants in each group did not provide the information to enable calculation of the time-weighted average MG activity of daily life over 3 years.||units on a scale||Standard Deviation|Mean
719171|NCT00294658|Secondary|Penalized Time-weighted Average Alternative Day Prednisone Dose (mg; Method 2: Penalized Using Dose at Time of Starting Azathioprine)|For each participant who took azathioprine, we penalized them by taking the prednisone dose at the time azathioprine commenced. We then applied the same method to compute the time-weighted alternative day prednisone dose from baseline, month 3, 4, 6 and every 3 months through 36 months.|baseline, month 1 , 2 , 3, 4, 6 and every 3 months through 36 months|Five participants in Thymectomy plus prednisone and 4 in Prednisone alone group did not provide the information to enable calculation of the penalized time-weighted average alternate-day prednisone dose (mg) over 3 years.||mg||Standard Deviation|Mean
719172|NCT00294658|Secondary|Penalized Time-weighted Average Alternative Day Prednisone Dose (mg; Method 1: Penalized Using Maximum Dose Before Azathioprine)|For each participant who took azathioprine, we penalized them by taking the maximum dose of prednisone before azathioprine was added. We then applied the same method to compute the time-weighted alternative day prednisone dose from baseline, month 3, 4, 6 and every 3 months through 36 months.|baseline, month 3, 4, 6 and every 3 months through 36 months|Five participants in Thymectomy plus prednisone and 4 in Prednisone alone group did not provide the information to enable calculation of the penalized time-weighted average alternate-day prednisone dose (mg) over 3 years.||mg||Standard Deviation|Mean
719223|NCT00294723|Primary|Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 104|Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 104 weeks (end of 52-week extension)|week 0, week 104|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.||percentage point of total HbA1c||Standard Error|Least Squares Mean
719173|NCT00294658|Secondary|Time-weighted Average Prescribed Alternate Day Prednisone Dose (mg)|Physicians reported prescribed alternate-day prednisone dose (mg) intake from baseline through withdrawn or completed 3 years follow up. The prescribed prednisone dosages had been weighted over the days of reporting period.|baseline-day 20, month 1,2, 3, 4, 6 and every 3 months through 36 months|Four participants in each group did not provide the information to enable calculation of the time-weighted average prescribed alternate-day prednisone dose (mg) over 3 years.||mg||Standard Deviation|Mean
719174|NCT00294658|Secondary|Reason for Hospitalization According to Medical Dictionary for Regulatory Activities Term|Number who had hospitalization: Thymectomy plus prednisone n=15 (out of 66); Prednisone alone n=31 (out of 60)|baseline to 3 years|||events|||Number
719175|NCT00294658|Secondary|Cumulative Number of Hospital Days|Number who had hospitalization: Thymectomy plus prednisone n=15 (out of 66); Prednisone alone n=31 (out of 60)|baseline to 3 years|||days||Standard Deviation|Mean
719176|NCT00294658|Secondary|Hospitalization for Exacerbation of Myasthenia Gravis||baseline to 2 years and baseline to 3 years|Number of participants who had hospitalized over 2 and 3 years||participants|||Number
719177|NCT00294658|Secondary|Classification of Serious Adverse Events||baseline to 3 years|One participant might had experienced more than one serious adverse event.||participants|||Number
719178|NCT00294658|Secondary|Number of Patients With at Least One Serious Adverse Events|Number of participant who experienced at least one serious adverse events over 3 years: Thymectomy plus prednisone n=25 (out of 66); Prednisone alone n=33 (out of 60)|baseline to 3 years|||participants|||Number
719179|NCT00294658|Secondary|Number of Serious Adverse Events|Number of participant who experienced at least one serious adverse events over 3 years: Thymectomy plus prednisone n=25 (out of 66); Prednisone alone n=33 (out of 60)|baseline to 3 years|||events|||Number
719180|NCT00294658|Secondary|Subgroup Analyses of Time-weighted Average Average Alternate-day Prednisone Dose (mg) by Age at Disease Onset|Participants reported alternate-day prednisone dose (mg) intake from baseline through withdrawn or completed 3 years follow up. The prednisone dosages had been weighted over the days of reporting period.|baseline, month 3, 4, 6 and every 3 months through 36 months|Five participants in Thymectomy plus prednisone and 4 in Prednisone alone group did not provide the information to enable calculation of the time-weighted average alternate-day prednisone dose (mg) over 3 years. Another 2 in Thymectomy plus prednisone group and 4 in Prednisone alone group did not provide age at disease onset information.||mg||Standard Deviation|Mean
719181|NCT00294658|Secondary|Subgroup Analyses of Time-weighted Average Alternate-day Prednisone Dose (mg) by Sex|Participants reported alternate-day prednisone dose (mg) intake from baseline through withdrawn or completed 3 years follow up. The prednisone dosages had been weighted over the days of reporting period.|baseline, month 3, 4, 6 and every 3 months through 36 months|Five participants in Thymectomy plus prednisone and 4 in Prednisone alone group did not provide the information to enable calculation of the time-weighted average alternate-day prednisone dose (mg) over 3 years.||mg||Standard Deviation|Mean
719182|NCT00294658|Secondary|Subgroup Analyses of Time-weighted Average Alternate-day Prednisone Dose (mg) by Prednisone Use at Enrollment|Participants reported alternate-day prednisone dose (mg) intake from baseline through withdrawn or completed 3 years follow up. The prednisone dosages had been weighted over the days of reporting period.|baseline, month 3, 4, 6 and every 3 months through 36 months|Five participants in Thymectomy plus prednisone and 4 in Prednisone alone group did not provide the information to enable calculation of time-weighted average alternate-day prednisone dose (mg) over 3 years. Another 1 in Prednisone alone group did not provide prednisone use at enrollment information.||mg||Standard Deviation|Mean
719183|NCT00294658|Secondary|Subgroup Analyses of Time-weighted Average Quantitative Myasthenia Gravis Score by Age at Disease Onset|Myasthenia Gravis (QMG) test. QMG total scores range from 0 to 39 for a given visit, with higher scores indicating more severe disease.|baseline, month 3, 4, 6 and every 3 months through 36 months|Four participants in each group did not provide the information to enable calculation of the time-weighted average Quantitative Myasthenia Gravis Weakness Score over 3 years. Another 2 participants in Thymectomy plus prednisone and 4 in Prednisone alone group did not provide the age at disease onset information.||units on a scale||Standard Deviation|Mean
719184|NCT00294658|Secondary|Subgroup Analyses of Time-weighted Average Quantitative Myasthenia Gravis Score by Sex|Myasthenia Gravis (QMG) test. QMG total scores range from 0 to 39 for a given visit, with higher scores indicating more severe disease.|baseline, month 3, 4, 6 and every 3 months through 36 months|Four participants in each group did not provide the information to enable calculation of the time-weighted Quantitative Myasthenia Gravis Weakness Score over 3 years.||units on a scale||Standard Deviation|Mean
719185|NCT00294658|Secondary|Subgroup Analyses of Time-weighted Average Quantitative Myasthenia Gravis Score by Prednisone Use at Enrollment|Myasthenia Gravis (QMG) test. QMG total scores range from 0 to 39 for a given visit, with higher scores indicating more severe disease.|baseline, month 3, 4, 6 and every 3 months through 36 months|Four participants in Thymectomy plus prednisone and 5 in Prednisone alone group did not provide information to enable the calculation of Time-weighted average Quantitative Myasthenia Gravis Score by prednisone use at enrollment over 3 years.||units on a scale||Standard Deviation|Mean
719186|NCT00294658|Primary|Time-weighted Average Alternate-day Prednisone Dose (mg) Measured Over 3 Years|Participants reported alternate-day prednisone dose (mg) intake from baseline through withdrawn or completed 3 years follow up. The prednisone dosages had been weighted over the days of reporting period.|baseline, month 1 , 2 , 3, 4, 6 and every 3 months through 36 months|Five participants in Thymectomy plus prednisone and 4 in Prednisone alone group did not provide the information to enable calculation of the time-weighted average alternate-day prednisone dose (mg) over 3 years.||mg||Standard Deviation|Mean
719210|NCT00294723|Secondary|Hypoglycaemic Episodes|Total number of hypoglycaemic episodes occuring from week 104 to end of trial (week 195). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 56 mg/dL. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 56 mg/dL.|weeks 104-195|Safety analysis set is all subjects who entered the year 3 extension at week 104.||episodes|||Number
719313|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks|||Correlation coefficient|||Number
719187|NCT00294658|Primary|Time-weighted Average Quantitative Myasthenia Gravis Weakness Score Over 3 Years|Myasthenia Gravis (QMG) test. QMG total scores range from 0 to 39 for a given visit, with higher scores indicating more severe disease. The time weighted average is a calculation that provides an integrated measure of the outcome over the time of followup. The denominator that was used to compute the time-weighted average for the Quantitative Myasthenia Gravis (QMG) score and the prednisone dose was the number of days from randomization to the last visit. Computations used the trapezoidal method where in the QMG score is multiplied by the number of days at this level from one visit to the next and added up over the entire followup experience and divided by the total number of days from randomization.|baseline, month 3, 4, 6 and every 3 months through 36 months|Four participants in each group did not provide the information to enable calculation of the time-weighted Quantitative Myasthenia Gravis Weakness Score over 3 years.||units on a scale||Standard Deviation|Mean
719188|NCT00294671|Secondary|Quality of Life Questionnaire: SF-36 Mental Component Score|The 36 item short-form health survey (SF-36) was used to assess the difference between treatment groups for change of mental component scores over 2 years treatment. Range 0-100; lower scores reflect lower quality-of-life.|Baseline, 1 and 2 years|||units on a scale||95% Confidence Interval|Mean
719189|NCT00294671|Secondary|Quality of Life Questionnaire: SF-36 Physical Component Score|The 36 item short-form health survey (SF-36) was used to assess the difference between treatment groups for change of physical component scores over 2 years treatment. Range 0-100; lower scores reflect lower quality-of-life.|Baseline, 1 and 2 years|Longitudinal analysis examined data from all 130 participants using intention-to-treat principles.||units on a scale||95% Confidence Interval|Mean
719190|NCT00294671|Secondary|Modified Body Mass Index (mBMI);|The product of body mass index (BMI) and serum albumin level (g/L) [kg/M2xg/L].|Baseline, 1 and 2 years|||kg/M2xg/L||95% Confidence Interval|Mean
719191|NCT00294671|Secondary|Kumamoto Neurologic Scale;|Change from baseline of the Kumamoto Score (0-102 points, increasing with disease severity), a clinical neurologic scale of motor, sensory, and autonomic function combined with heart and kidney end organ measures developed to track disease progression in Familial Amyloid Polyneuropathy (ATTR-FAP)|Baseline, 1 and 2 years|||units on a scale||95% Confidence Interval|Mean
719192|NCT00294671|Primary|Neurologic Impairment Score + 7 (NIS+7)|The primary endpoint, the difference in polyneuropathy progression between treatments, was measured by the Neuropathy Impairment Score plus 7 nerve tests (NIS+7) which ranges from 0 (no neurologic deficits) to 270 points (no detectable peripheral nerve function).|Baseline, 1 and 2 years|Longitudinal analysis examined data from all 130 participants using intention-to-treat principles.||units on a scale||95% Confidence Interval|Mean
719193|NCT00294684|Other Pre-specified|Serum Biomarkers of Sufficiency of Fat-soluble Vitamins - Vitamin A|Vitamin A sufficiency is measured by the molar ratio of serum retinol/retinol binding protein|12 months|Although the protocol specified analyses of serum biomarkers as secondary outcomes, the intent was to only perform these analyses if the primary endpoint showed sufficient efficacy. Given the lack of efficacy of steroids (vs placebo), the analyses of fat-soluble vitamins were not performed; thus, data are not summarized for this assessment.|||||
719194|NCT00294684|Other Pre-specified|Serum Biomarkers of Sufficiency of Fat-soluble Vitamins - Vitamin E|Vitamin E sufficiency is measured as the ratio of serum vitamin E/total lipids|12 Months|Although the protocol specified analyses of serum biomarkers as secondary outcomes, the intent was to only perform these analyses if the primary endpoint showed sufficient efficacy. Given the lack of efficacy of steroids (vs placebo), the analyses of fat-soluble vitamins were not performed; thus, data are not summarized for this assessment.|||||
719195|NCT00294684|Other Pre-specified|Serum Biomarkers of Sufficiency of Fat-soluble Vitamins - Vitamin K|Vitamin K sufficiency is measured by INR (international normalized ratio)|12 Months|Although the protocol specified analyses of serum biomarkers as secondary outcomes, the intent was to only perform these analyses if the primary endpoint showed sufficient efficacy. Given the lack of efficacy of steroids (vs placebo), the analyses of fat-soluble vitamins were not performed; thus, data are not summarized for this assessment.|||||
719196|NCT00294684|Other Pre-specified|Serum Biomarkers of Sufficiency of Fat-soluble Vitamins - Vitamin D|Vitamin D sufficiency is measured by the serum level of 25-hydroxy vitamin D|12 Months|Although the protocol specified analyses of serum biomarkers as secondary outcomes, the intent was to only perform these analyses if the primary endpoint showed sufficient efficacy. Given the lack of efficacy of steroids (vs placebo), the analyses of fat-soluble vitamins were not performed; thus, data are not summarized for this assessment.|||||
719197|NCT00294684|Other Pre-specified|Serum Biomarkers of Sufficiency of Fat-soluble Vitamins - Vitamin A|Vitamin A sufficiency is defined as the molar ratio of serum retinol/retinol binding protein|24 months|Although the protocol specified analyses of serum biomarkers as secondary outcomes, the intent was to only perform these analyses if the primary endpoint showed sufficient efficacy. Given the lack of efficacy of steroids (vs placebo), the analyses of fat-soluble vitamins were not performed; thus, data are not summarized for this assessment.|||||
719198|NCT00294684|Other Pre-specified|Serum Biomarkers of Sufficiency of Fat-soluble Vitamins - Vitamin D|Vitamin D sufficiency is measured by the serum level of 25-hydroxy vitamin D|24 Months|Although the protocol specified analyses of serum biomarkers as secondary outcomes, the intent was to only perform these analyses if the primary endpoint showed sufficient efficacy. Given the lack of efficacy of steroids (vs placebo), the analyses of fat-soluble vitamins were not performed; thus, data are not summarized for this assessment.|||||
719199|NCT00294684|Other Pre-specified|Serum Biomarkers of Sufficiency of Fat-soluble Vitamins - Vitamin K|Vitamin K sufficiency is measured by INR (international normalized ratio)|24 Months|Although the protocol specified analyses of serum biomarkers as secondary outcomes, the intent was to only perform these analyses if the primary endpoint showed sufficient efficacy. Given the lack of efficacy of steroids (vs placebo), the analyses of fat-soluble vitamins were not performed; thus, data are not summarized for this assessment.|||||
719200|NCT00294684|Other Pre-specified|Serum Biomarkers of Sufficiency of Fat-soluble Vitamins - Vitamin E|Vitamin E sufficiency is measured as the ratio of serum vitamin E/total lipids|24 Months|Although the protocol specified analyses of serum biomarkers as secondary outcomes, the intent was to only perform these analyses if the primary endpoint showed sufficient efficacy. Given the lack of efficacy of steroids (vs placebo), the analyses of fat-soluble vitamins were not performed; thus, data are not summarized for this assessment.|||||
719201|NCT00294684|Secondary|Presence of Ascites at 24 Months||24 Months|Participants with their native liver at 24 months||participants|||Number
719211|NCT00294723|Secondary|Hypoglycaemic Episodes|Total number of hypoglycaemic episodes occuring from baseline (week 0) to 104 weeks (end of the 52-week extension). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 56 mg/dL. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 56 mg/dL.|weeks 0-104|Full safety analysis set is all subjects who had been exposed to at least one dose of the study products.||episodes|||Number
719212|NCT00294723|Secondary|Change in Prandial Increments of Plasma Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 156|Change in mean prandial increments (incr.) of plasma glucose from baseline (week 0) to 156 weeks. The 8 time points for self-measured 8-point plasma glucose profiles were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min. Mean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between post- and pre-meal values (for breakfast, lunch and dinner) divided by three.|week 0, week 156|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.||mg/dL||Standard Error|Least Squares Mean
719213|NCT00294723|Secondary|Change in Prandial Increments of Plasma Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 104|Change in mean prandial increments of plasma glucose from baseline (week 0) to 104 weeks (end of 52-week extension). The 8 time points for self-measured 8-point plasma glucose profiles were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min. Mean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between post- and pre-meal values (for breakfast, lunch and dinner) divided by three.|week 0, week 104|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.||mg/dL||Standard Error|Least Squares Mean
719214|NCT00294723|Secondary|Change in Prandial Increments of Plasma Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 52|Change in mean prandial increments of plasma glucose from baseline (week 0) to 52 weeks (end of double-blind period). The 8 time points for self-measured 8-point plasma glucose profiles were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min. Mean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between post- and pre-meal values (for breakfast, lunch and dinner) divided by three.|week 0, week 52|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.||mg/dL||Standard Error|Least Squares Mean
719215|NCT00294723|Primary|Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 156|Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 156 weeks|week 0, week 156|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.||percentage point of total HbA1c||Standard Error|Least Squares Mean
719216|NCT00294723|Secondary|Change in Mean Postprandial Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 156|Change in mean postprandial glucose (PPG) based on self-measured 8-point plasma glucose profiles from baseline (week 0) to 156 weeks. The 8 time points for self-measurements of plasma glucose were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min.|week 0, week 156|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.||mg/dL||Standard Error|Least Squares Mean
719217|NCT00294723|Secondary|Change in Mean Postprandial Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 104|Change in mean postprandial glucose (PPG) based on self-measured 8-point plasma glucose profiles from baseline (week 0) to 104 weeks (end of 52-week extension). The 8 time points for self-measurements of plasma glucose were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min.|week 0, week 104|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.||mg/dL||Standard Error|Least Squares Mean
719218|NCT00294723|Secondary|Change in Mean Postprandial Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 52|Change in mean postprandial glucose (PPG) based on self-measured 8-point plasma glucose profiles from baseline (week 0) to 52 weeks (end of double-blind period). The 8 time points for self-measurements of plasma glucose were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min.|week 0, week 52|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.||mg/dL||Standard Error|Least Squares Mean
719219|NCT00294723|Secondary|Change in Fasting Plasma Glucose at Week 156|Change in fasting plasma glucose (FPG) from baseline (week 0) to 156 weeks|week 0, week 156|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.||mg/dL||Standard Error|Least Squares Mean
719220|NCT00294723|Secondary|Change in Fasting Plasma Glucose at Week 104|Change in fasting plasma glucose (FPG) from baseline (week 0) to 104 weeks (end of 52-week extension)|week 0, week 104|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.||mg/dL||Standard Error|Least Squares Mean
719221|NCT00294723|Secondary|Change in Fasting Plasma Glucose at Week 52|Change in fasting plasma glucose (FPG) from baseline (week 0) to 52 weeks (end of double-blind period)|week 0, week 52|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.||mg/dL||Standard Error|Least Squares Mean
719222|NCT00294723|Secondary|Change in Body Weight at Week 156|Change in body weight from baseline (week 0) to 156 weeks|week 0, week 156|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.||kg||Standard Error|Least Squares Mean
719224|NCT00294723|Secondary|Change in Body Weight at Week 104|Change in body weight from baseline (week 0) to 104 weeks (end of 52-week extension)|week 0, week 104|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.||kg||Standard Error|Least Squares Mean
719225|NCT00294723|Secondary|Change in Body Weight at Week 52|Change in body weight from baseline (week 0) to 52 weeks (end of double-blind period)|week 0, week 52|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.||kg||Standard Error|Least Squares Mean
719226|NCT00294723|Primary|Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 52|Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 52 weeks (end of double-blind period)|week 0, week 52|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.||percentage point of total HbA1c||Standard Error|Least Squares Mean
719227|NCT00294762|Secondary|Duration of Tumor Response|Median length of time that tumor showed any type of response, ie, CR, PR, or SD|While receiving study treatment; assessed every 21 days until progression (maximum 28.8 months).|All patients who had any type of tumor response, ie, CR, PR, or SD||Months||Full Range|Median
719228|NCT00294762|Secondary|Best Tumor Response|Change in size of tumor: Complete Response (CR) = no measurable tumor; Partial Response (PR) = 30% decrease in size of measurable tumor; Stable Disease (SD) = measurable tumor size has not changed; Progressive Disease (PD) = measurable tumor larger than at baseline|While receiving study treatment; assessed every 21 days until progression (maximum 28.8 months)|All patients who received at least 1 dose of study drug and who had both a baseline and at least one on-treatment tumor assessment||Percent of Patients|||Number
719229|NCT00294762|Secondary|Overall Survival|Median number of months from first study treatment until time of death|From first study treatment until time of death (maximum 29.0 months)|All patients who received at least 1 dose of study drug||Months||Full Range|Median
719230|NCT00294762|Secondary|Overall Survival at 12 Months|Percentage of patients alive after 12 months of study treatment|12 months from 1st dose|All patients who received at least 1 dose of study drug||Percent of Patients||95% Confidence Interval|Number
719231|NCT00294762|Secondary|Progression-free Survival|Median time until disease progression. Disease progression defined as radiological and/or symptomatic disease progression or death in absence of progression.|Until time of disease progression, as assessed every 21 days (maximum 28.8 months)|All patients who received at least 1 dose of study drug||months||Full Range|Median
719232|NCT00294762|Primary|6-month Progression-free Survival|Percentage of patients who's disease had not progressed at 6 months. Disease progression defined as radiological and/or symptomatic disease progression or death in absence of progression.|6 months after first dose|All patients who received at least one dose of study drug.||Percentage of Patients||95% Confidence Interval|Number
719233|NCT00295009|Primary|Overall Success|"Overall success was a composite endpoint. A ProDisc patient was considered an overall success if, and only if, ALL of the following criteria were met:
ODI score improved by at least 15% from baseline;
SF-36 score improved from baseline;
Neurologic parameters maintained or improved from baseline;
No re-operations required to modify or remove the implant; and
Independent radiographic review confirmed no migration/subsidence, radiolucency, loss of disc height, loss of range of motion, or boney fusion.
A Fusion patient was a considered to be a success if, and only if, ALL of the following criteria were met:
Items numbered 1-3, above; 4. No re-operations required to modify the fusion site or correct a complication with an implant; and 5. Independent radiographic review confirmed strong evidence of fusion and no motion, visible gaps in fusion mass, loss of disc height, migration/subsidence, implant loosening, halos, or radiolucencies"|60 Months|Patients who completed all 60 month visit analyses||percentage of overall successes|||Number
719234|NCT00295009|Primary|Overall Success|"Overall success was a composite endpoint.
A ProDisc patient was considered an overall success if, and only if, ALL of the following criteria were met:
ODI score improved by at least 15% from baseline;
SF-36 score improved from baseline;
Neurologic parameters maintained or improved from baseline;
No re-operations to modify or remove the implant; and
Independent radiographic review confirmed no migration/subsidence, radiolucency, loss of disc height, loss of range of motion, or boney fusion.
A Fusion patient was a considered to be a success if, and only if, ALL of the following criteria were met:
Same as above
Same as above
Same as above
No re-operations to modify the fusion site or correct a complication with an implant; and
Independent radiographic review confirmed strong evidence of fusion and no motion, visible gaps in fusion mass, loss of disc height, migration/subsidence, implant loosening, halos, or radiolucencies"|24 Months|Patients who completed all 24 month visit analyses||percentage of overall successes|||Number
719235|NCT00295061|Primary|Alpha-1 MP vs. Prolastin® of Area Under the Curve (AUC) From Day 0 to Day 7|"The primary objective of this study was to demonstrate the pharmacokinetic comparability (geometric least square mean ratio of AUC between the Alpha-1 MP vs. Prolastin®, 90% confidence interval falls within 0.80-1.25, FDA Guidance as being bioequivalent between two treatments) of Alpha-1 MP to Prolastin® in subjects with alpha-1-anti-trypsin (AAT) deficiency by comparing AUC from Day 0 to Day 7 of plasma Alpha1-PI measured by the functional activity (potency) assay. AUC from Day 0 to Day 7 was calculated at steady state at the end of the first and second 8-week treatment periods during the 16-week double-blind, crossover phase."|Day 0 to Day 7|||mg*h/mL|||Number
719236|NCT00295490|Secondary|Adverse Event Reporting|To identify Group differences between the number of adverse event recorded by patient for both serious and non serious adverse events, as well as events considered being attributable to the study medication.|Baseline and weeks 2,4,6,8,12 and 16|Zero participants were analysed as the study was terminated prematurely||Participants||95% Confidence Interval|Number
719237|NCT00295490|Secondary|Complementary and Alternative Medicine Beliefs Inventory|Questionnaire to assess changes in attitudes and health beliefs to CAM.the questionnaire as 17 questions, each scored on a 7 point likert scale from strongly disagree to strongly agree; a higher score indicates stronger belief in the measure. Minimum score 17, maximum score 119|four monthly|Zero participants were analysed as the study was terminated prematurely||unit on scale||95% Confidence Interval|Mean
719269|NCT00295880|Primary|Median Number of Days to Neutrophil Engraftment|Number of days to neutrophil recovery observed in recipients of two umbilical cord blood units (UCB)administered i.v. Neutrophil recovery is defined as first of 3 consecutive days with ANC (absolute neutrophil count) greater than or equal to 500/ul.|Daily through Day 60 post transplant|||Days||Full Range|Median
719238|NCT00295490|Secondary|Patient Global Assessment|To assess changes in the subject’s well-being based on 7 point likert scale ranging from very poor (0 point) to very good (7 point). Outcome was recorded at baseline, week 8 and end of treatment at week 16. We reported outcome as the change in patient global assessment from baseline to end of treatment at week 16.|Baseline, week 8 and week 16|Zero participants were analysed as the study was terminated prematurely||Unit on scale (Likert from very poor to||95% Confidence Interval|Mean
719239|NCT00295490|Secondary|Short Form-36 (SF-36)|Quality of Life assessment containing 8 scales clustered into 2 summary scales: physical health and mental health. Each question is scored out from 0 (indicating worst health) to 100 (indicating best health). Mean scores for the 8 scales (total scores/no questions completed) are calculated to give a total score for each of the two summary scales between 0 (worst health) and 100 (best health). SF36 was recorded at baseline, week 8 and at the end of treatment at week 16. we reported the change from baseline to end of treatment as the outcome.|Baseline, week 8 and week 16|Zero participants were analysed as the study was terminated prematurely.||Unit of scale||95% Confidence Interval|Mean
719240|NCT00295490|Secondary|Stiffness Subscale on the The Western Ontario and Mc Master University OA Index|Subscale assessed by 100mm VAS based on two questions addressing stiffness in osteoarthritis;a higher score indicating worse symptoms. The VAS used terminators of no stiffness (0mm) to extreme stiffness (100mm). The measure was recorded at baseline, week 8 and week 16. We reported the outcome as the change from baseline to end of treatment at week 16.|Baseline, week 8 and week 16|Zero participants were analysed as the study was terminated prematurely.||Unit on 100mm VAS scale||95% Confidence Interval|Mean
719241|NCT00295490|Secondary|Disability Subscale on The Western Ontario and Mc Master University OA Index|Subscale assessed by 100mm VAS based on twelve questions addressing disability in osteoarthritis with a higher score indicating worse symptoms. The VAS used terminators of no disability (0mm) to extreme disability (100mm). The measure was recorded at baseline, week 8 and week 16. We reported the outcome as the change from baseline to end of treatment at week 16.|baseline, 8 and 16 weeks|Zero participants were analysed as the study was terminated prematurely||unit on 100mm VAS scale||95% Confidence Interval|Mean
719242|NCT00295490|Secondary|Pain Subscale on Western Ontario and Mc Master University OA Index|Subscale assessed by 100mm VAS based on five questions addressing pain in osteoarthritis using the terminators no pain (0mm) to extreme pain (100mm). a higher score therefore indicates more severe pain. This outcome was recorded at baseline, week 8 and week 16 (end of treatment). The outcome for this study was reported as the change in WOMAC pain score from baseline to end of treatment at week 16.|Baseline, week 8 and week 16|Zero participants were analysed as the study was terminated prematurely.||Unit on 100mm VAS scale||95% Confidence Interval|Mean
719243|NCT00295490|Primary|Western Ontario and Mc Master University OA Index (WOMAC)|WOMAC is a disease specific outcome measure for osteoarthritis. It has three subscales assessing pain (5 questions), stiffness (2 questions) and function (15 questions). together the subscales give an overall total score ranging from 0 (worst) to 100 (best; an increase in total score indicates an improvement in health. THe outcome was measured at baseline, week 8 and week 16. In this study the primary outcome was the reduction in WOMAC total score from baseline to the end of treatment at week 16.|Baseline, week 8 and week 16|Zero participants were analysed as the study was terminated prematurely.||Unit on 100mm scale||Standard Deviation|Mean
719244|NCT00295503|Secondary|Overall Survival|overall survival was measured from time of initiation of treatment to death from any cause|from time of enrollment to death from any cause. Patients still alive at study end were censored with a minimum follow up of 6 months.|||months||95% Confidence Interval|Median
719245|NCT00295503|Secondary|Response Rate|response was assessed by the RECIST criteria (version 1.0). Per those criteria, progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|from time of enrollment to time of best response or death from any cause, whichever came first up to 100 months|||percentage of participants|||Number
719246|NCT00295503|Primary|Progression Free Survival Rate at 6 Months|This is the percentage of patients alive and progression-free at 6 months from initiation of treatment.|patients progression free at 6 months|||percentage of participants|||Number
719247|NCT00295633|Secondary|Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24|Mean change from baseline for 0 to 180 minutes PPG AUC achieved at each dose of saxagliptin plus TZD versus placebo plus TZD at Week 24, adjusted for baseline value.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.||mg*min/dL||Standard Error|Mean
719248|NCT00295633|Secondary|Percentage of Participants Achieving A1c <7% at Week 24|Percentage of participants achieving A1C < 7%, the American Diabetic Association’s defined goal for glycemia, at each dose of saxagliptin plus TZD versus placebo plus TZD at Week 24.|Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in the Week 24 LOCF analysis, subjects must have had at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.||Percentage of participants|||Number
719249|NCT00295633|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Mean change from baseline in FPG at Week 24, adjusted for baseline value.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.||mg/dL||Standard Error|Mean
719250|NCT00295633|Primary|Change From Baseline in Hemoglobin A1c (A1C) at Week 24|Mean change from baseline in A1C at Week 24, adjusted for baseline value.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement. If participant received rescue medication, measurement must have been taken before rescue.||percent||Standard Error|Mean
719282|NCT00296244|Secondary|New-onset Diabetes Mellitus (NODM) as Secondary Outcome|The incidence of new-onset Diabetes mellitus (NODM, based on percentage of previously non-diabetic patients who developed DM post-transplantation, was similar between the 2 groups.|6 months|||Percentage of participants|||Number
719251|NCT00295750|Secondary|Participants With Markedly Abnormal Change in Vital Signs and Body Weight|Vital signs and body weight included incidence of markedly abnormal changes from baseline to the end of the study in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of patients in each group with normal baseline and markedly abnormal value post-baseline.|12 months|ITT population. The first value in the category represents the actual clinical reading and the second is the change from baseline for blood pressure (units: millimeters of mercury) and heart rate (units:beats per minute). The weight category includes patients whose percent weight change from baseline fit the stated ranges.||participants|||Number
719252|NCT00295750|Secondary|The Mean Value of QTc Interval as Measured by Electrocardiogram|The QTc interval results are calculated with Fridericia’s correction. QTc intervals are a standard evaluation of an electrocardiogram and help measure the risk of developing ventricular arrhythmias.|12 months|ITT population. End of Study values obtained at day 364 (+-7 days) for patients who completed. Patients who withdrew early had variable timeframes for the end of study value.||milliseconds||Standard Deviation|Mean
719253|NCT00295750|Secondary|Participants With Markedly Abnormal Change in Laboratory Variables (>=20 Percent of Patients)|Criteria for lab values changes from baseline to the end of the study considered markedly abnormal were set for each lab test. If 20% of patients reached that value, the results were reported.|Baseline to Day 364|ITT population||participants|||Number
719254|NCT00295750|Secondary|Participants Grouped by Time to Prostate-specific Antigen Failure|The time to prostate specific antigen failure was defined as the days from first dosing (scheduled dosing days) where an increase in serum prostate specific antigen of ≥50% from nadir and a least 5 ng/mL measured on two consecutive occasions at least two weeks apart was noted.|12 months|ITT population. Missing values were not imputed for this endpoint. Number in table represents the number of patients with prostate-specific antigen failure.||participants|||Number
719255|NCT00295750|Secondary|Percentage Change in Prostate-specific Antigen From Baseline to Day 14 and Day 28|Percentage change from Baseline to Day 14 and Day 28 in prostate-specific antigen, which is a clinically important biological marker for treatment effect and prostate cancer progression.|Days 14 and 28|ITT population.||percent change||Inter-Quartile Range|Median
719256|NCT00295750|Secondary|Frequency and Size of Testosterone Changes at Day 255 and/or Day 259 Compared to the Testosterone Level at Day 252|Testosterone increases on Day 255 and/or on Day 259 (highest value of Day 255 and Day 259 was used) were compared with Day 252 values. Patients were categorised with shifts of <=-0.25, >-0.25-0, >0-0.25, >0.25-0.5 and >0.5 ng/mL from mean testosterone levels on Day 252.|Day 252, Day 255, and Day 259|ITT population who had blood samples drawn on Day 252, Day 255, and Day 259.||participants|||Number
719257|NCT00295750|Secondary|Percentage of Patients With Testosterone Level <=0.5 ng/mL at Day 3|This outcome measure presents the testosterone levels 3 days after the initial dose of trial medication.|3 days|ITT population.||percentage of patients||95% Confidence Interval|Mean
719258|NCT00295750|Secondary|Percentage of Patients With Testosterone Surge During the First Two Weeks of Treatment|A patient was defined as having a testosterone surge if the testosterone level exceeded baseline by >=15% on any two days during the first two weeks of treatment (i.e. two of Study Days 1, 3, 7 and 14).|2 weeks|ITT population. If one or more of the testosterone values on Days 1, 3, 7 or 14 was missing, the last observation was carried forward.||percentage of patients||95% Confidence Interval|Mean
719259|NCT00295750|Primary|Percentage of Patients With Testosterone <=0.5ng/mL From Day 28 Through Day 364|Kaplan-Maier estimates of the cumulative probabilities of testosterone <=0.5 ng/mL from Day 28 to Day 364. The degarelix response rate estimation determined whether the lower bound of the 95% confidence interval for the cumulative probability of testosterone <=0.5 ng/mL from Day 28 to Day 364 was no lower than 90%.|12 months|Intent-to-treat (ITT) population.||percentage of patients||95% Confidence Interval|Mean
719260|NCT00295854|Primary|"Number Subjects at Least Moderately Improved for Each Treatment Group in Patient Reported Global Response Assessment (GRA)"|The primary endpoint was the GRA overall change “in their condition” at Week 8. Each patient completed the questionnaire that rated the improvement in their IC symptoms based on responses to the GRA questions. Each question asked the patient to describe the OVERALL CHANGE in pain, urgency, frequency or overall change in their problem compared to the status before taking the study medication. Each parameter was rated on a 7 point scale: markedly worse, moderately worse, mildly worse, same, mildly improved, moderately improved and markedly improved.|8 weeks|||participants|||Number
719261|NCT00295854|Secondary|Number of Responders for GRA Assessment in Their Condition at Week 4.|Responders were defined as patients who were ‘moderately improved’ or ‘markedly improved’ and non-responders were defined as patients who were ‘markedly worse’, ‘moderately worse’, ‘mildly worse’, no change, or ‘mildly improved’ on the GRA assessments.|4 weeks|||participants|||Number
719262|NCT00295880|Secondary|Number of Patients With Chronic Graft-versus-host Disease (GVHD).|Number of umbilical cord blood transplant patients with limited and extensive chronic GVHD.|1 year post transplant|Only 7 patients were at risk for chronic GVHD||Participants|||Number
719263|NCT00295880|Secondary|Number of Patients With Grade III-IV Acute Graft-versus-host Disease (GVHD)|Number of umbilical cord blood transplant patients developing severe GVHD at 100 days post transplant.|100 days post transplant|2 patients were not yet graded for acute gvhd||Participants|||Number
719264|NCT00295880|Secondary|Number of Patients Surviving at Day 100 and 1 Year.|Overall survival of patients-Number of patients who were alive at Day 100 and 1 year post transplant.|Day 100 and 1 year|||Participants|||Number
719265|NCT00295880|Secondary|Number of Patients With Transplant-related Mortality (TRM)|Number of patients who were deceased at days 100 and 180 from any cause other than relapse.|Day 100 and Day 180|||Participants|||Number
719266|NCT00295880|Secondary|Number of Patients With Acute Graft-versus-host Disease (GVHD)|Number of patients who exhibited grade II-IV acute GVHD at 100 days post umbilical cord blood transplant.|100 days post transplant|2 patients were not graded for acute GVHD due to graft failure.||Participants|||Number
719267|NCT00295880|Secondary|Number of Patients With Evidence of Engraftment.|Number of patients who received both cord blood units and achieved sustained donor engraftment|1 year|1 patient was not evaluable due to graft failure||Participants|||Number
719268|NCT00295880|Secondary|Number of Patients Achieving Neutrophil Recovery|Number of patients with sustained neutrophil recovery with chimerism (evidence of engraftment of both cord blood transplants) at 6 months.|6 months|Patients who completed treatment.||Participants|||Number
719270|NCT00296036|Secondary|Determine Whether the Prophylactic Use of a Topical Urea/Lactic Acid Cream in Combination With Vitamin B6 Can Decrease the Incidence and/or Severity of Capecitabine Caused Palmar-plantar Erythrodysesthesia.|A patient self-reported hand-foot syndrome diary (HFSD) was completed daily while applying the cream. Patients rated skin severity symptoms individually in their hands and in their feet. Definitions of symptoms, which were based on Common Terminology Criteria for Adverse Events (CTCAE) v3.0, were provided to patients. The number of patients reporting moderate to severe symptoms were tabulated.|First 3 weeks of treatment|This endpoint is not analyzed due to the fact that Vitamin B6 had already been shown to be ineffective. Additionally, any insignificance may be due to lack of power from the smaller (Arms I, II, III and IV) than target sample size.|||||
719271|NCT00296036|Secondary|Evaluate the Potential Toxicity of Vitamin B6.|Frequency and severity of adverse events reported by patients in weekly diary and evaluated through clinical assessment by NCI CTCAE v3.0. The number of patients reporting grade 3 or higher events are reported in this outcome measure. For a full list of all events, please refer to the Adverse Events section of this report.|up to 4, 21-day cycles|This endpoint is not analyzed due to the fact that Vitamin B6 had already been shown to be ineffective. Additionally, any insignificance may be due to lack of power from the smaller (Arms I, II, III and IV) than target sample size.|||||
719272|NCT00296036|Secondary|Determine Whether the Prophylactic Use of Vitamin B6 Can Decrease the Incidence and/or Severity of Capecitabine-caused Palmar-plantar Erythrodysesthesia (HFSD).|A patient self-reported hand-foot syndrome diary (HFSD) was completed daily while applying the cream. Patients rated skin severity symptoms individually in their hands and in their feet. Definitions of symptoms, which were based on Common Terminology Criteria for Adverse Events (CTCAE) v3.0, were provided to patients. The number of patients reporting moderate to severe symptoms were tabulated and percentages are reported.|First 3 weeks of treatment|This endpoint is not analyzed due to the fact that Vitamin B6 had already been shown to be ineffective. Additionally, any insignificance may be due to lack of power from the smaller (Arms I, II, III and IV) than target sample size.|||||
719273|NCT00296036|Secondary|To Evaluate the Potential Toxicity of Urea/Lactic Acid Cream|Frequency and severity of adverse events reported by patients in weekly diary and evaluated through clinical assessment by NCI CTCAE v3.0. The number of patients reporting grade 3 or higher events are reported in this outcome measure. For a full list of all events, please refer to the Adverse Events section of this report.|Up to 4, 21-day cycles|All patients that were evaluated for adverse events were included in this analysis.||participants|||Number
719274|NCT00296036|Primary|To Determine Whether the Prophylactic Use of a Topical Urea/Lactic Acid Cream Can Decrease the Incidence/Severity of Capecitabine-caused Palmar-plantar Erythrodysesthesia|A patient self-reported hand-foot syndrome (HFSD), also known as palmar-plantar erythrodysesthesia, was completed daily while applying the cream. Patients rated skin severity symptoms individually in their hands and in their feet. Definitions of symptoms, which were based on Common Terminology Criteria for Adverse Events (CTCAE) v3.0, were provided to patients. The number of patients reporting moderate to severe symptoms in either hands or feet were tabulated and percentages are reported.|First 3 weeks of treatment|Eight patients from the Urea/Lactic Acid group were not included in the primary analysis (1 did not fill out the diary, 1 refused treatment, 3 had adverse events before completing the diary, and 3 for other reasons). For the placebo arm, 11 were excluded (2 refused further treatment, 2 had adverse events, and 7 went off for other reasons).||percentage of participants|||Number
719275|NCT00296192|Secondary|"Time of First Off Reversal"|"Number of minutes to first reversal of symptoms from off to on. Estimated via Kaplan-Meier estimation method. On and off state refer to periods where Parkinson's disease symptoms are not present (on) and periods where symptoms are present (off); the on/off determination at each assessment timepoint was made by the investigator."|Up to 6 hours post-dose|Full Analysis Set: Subjects receiving at least one delivery of trial medication and with at least one post-baseline efficacy measurement.||minutes||95% Confidence Interval|Median
719276|NCT00296192|Secondary|"Success Rate (Percentage of Subjects Achieving Off Reversals)"|"Subjects reversing from off to on following initiation of treatment. On and off state refer to periods where Parkinson's disease symptoms are not present (on) and periods where symptoms are present (off); the on/off determination at each assessment timepoint was made by the investigator."|Up to 6 hours post-dose|Full Analysis Set: Subjects receiving at least one delivery of trial medication and with at least one post-baseline efficacy measurement.||percentage of participants|||Number
719277|NCT00296192|Secondary|Change From Baseline to 34 Minutes Post-dose in Tapping Rate (Taps/Min)|One-minute tapping rate will be calculated as the number of times a subject could tap on two 4 x 4 cm marks placed on a board 30 cm apart during 1 minute (30 cm measured from the inner border of the two boxes).|Baseline and 34 minutes post-dose|Full Analysis Set: Subjects receiving at least one delivery of trial medication and with at least one post-baseline efficacy measurement. Missing values at 34 minutes post-dose timepoint were not imputed; number of observations at 34 minutes post-dose timepoint may be less than that for baseline timepoint.||taps per minute||Standard Deviation|Mean
719278|NCT00296192|Secondary|Change From Baseline at 24 Minutes Post-dose in Unified Parkinson Disease Rating Scale (UPDRS) Part III Motor Examination|The Unified Parkinson's Disease Rating Scale (UPDRS) is a scale for the assessment of function in Parkinson’s disease. UPDRS Part III measures Motor Examination. Range: 0 (Best score possible) to 56 (Worst score possible) Change = 24 minute value minus baseline value.|Baseline, and 24 minutes post-dose|Full Analysis Set: Subjects receiving at least one delivery of trial medication and with at least one post-baseline efficacy measurement. Missing values at 24 minutes post-dose timepoint were not imputed; number of observations at 24 minutes post-dose timepoint may be less than that for baseline timepoint.||score on a scale||Standard Deviation|Mean
719279|NCT00296192|Primary|Number of Subjects Who Complete the Trial||15 days|Full Analysis Set: Subjects receiving at least one delivery of trial medication and with at least one post-baseline efficacy measurement.||participants|||Number
719280|NCT00296231|Secondary|Transcutaneous CO2 Measurements as a Trend Throughout Intervention|We used a transcutaneous CO2 monitor (TCOM) as a safety device throughout the study. We analyzed the change in TCOM readings recorded every 30 minutes (5 measurements) to determine safety|2 hours|||torr||Standard Deviation|Mean
719281|NCT00296231|Primary|pCO2 Measurements Post-intervention, as Compared to Pre-intervention Values|Capillary partial pressure of CO2 (pCO2) was measured before and after 2 hours of nasal high frequency ventilatiion in a group of subjects. Each served as his/her own control.|2 hours|||mm Hg||Standard Deviation|Mean
719283|NCT00296244|Secondary|Incidence and Severity of HCV Recurrence Post-OLT|The incidence and severity of HCV recurrence based on Hepatitis C PCR levels and protocol liver biopsy findings were found to be similar between the 2 groups.|6 months post-transplant|Only patients with HCV cirrhosis as the main indication for OLT were included in this analysis||Percentage of participants|||Number
719284|NCT00296244|Secondary|Infection as an Adverse Effect of Steroids|Incidence of bacterial infection was similar in the control group as well as study group, 4 patients in both groups had infection|3 months post-transplant|||Percentage of participants|||Number
719285|NCT00296244|Primary|Acute Rejection Rate|Biopsy proven acute rejection defined by biochemical and histological changes as well as the need for temporary steroid use occurred in 1 patient in each group both of which were steroid responsive|6 months post-transplant|||Percentage of participants|||Number
719286|NCT00296244|Primary|Patient Survival Rate|Percentage of recipients who are still alive at the end of 1 and 2 years.|1 and 2 years|||Percentage of participants|||Number
719287|NCT00296244|Primary|Graft Survival Rate|Percentage of recipients whose liver grafts are still working at the end of 1 and 2 years.|1 and 2 years|||percentage of participants|||Number
719288|NCT00296296|Secondary|Count of Participants With Biopsy Proven Acute Rejection at One Year Post Transplantation||1 year post-transplantation|||Participants|||Count of Participants
719289|NCT00296296|Secondary|Patient Survival at One Year Post Transplantation|Count of participants alive at one year post transplantation|Up to 1 year post-transplantation|||Participants|||Count of Participants
719290|NCT00296296|Primary|Estimated Glomerular Filtration Rate (eGFR) 1 Year Following Transplantation|Values of ≥60 ml/min/1.73 m^2 are considered optimal; ≥30-59 ml/min/1.73 m^2 are indicative of successful graft function; lower values are indicative or graft dysfunction.|1 year post-transplantation|||Participants|||Count of Participants
719291|NCT00296296|Primary|Freedom From Insulin Therapy Post Transplant|The count of participants with freedom from insulin therapy post transplant is reported.|From hospital discharge to 1 year post-transplant|||Participants|||Count of Participants
719292|NCT00296322|Secondary|Overall Survival||3 years|||percentage of participants||95% Confidence Interval|Number
719293|NCT00296322|Secondary|Toxicity Profile (According to NCI CTC Version 2.0)|Because safety profile in oncology study is evaluated for each toxicity, it is impossible to present the overall patient number. Instead, we presented the number of patients who declined study therapy due to adverse events or patient will.|up to 1 year|||participants|||Number
719294|NCT00296322|Primary|Relapse-free Survival||3 years|||percentage of participants||95% Confidence Interval|Number
719295|NCT00296335|Secondary|Number of Patients With Adverse Events|Per National Cancer Institute Common Toxicity Criteria version 2.0, up to 3 years|Up to 3 years|||participants|||Number
719296|NCT00296335|Secondary|Overall Survival Rate|Overall survival rate at 3 years was defined as the proportion of patients who were alive at 3 years after surgery.|3 years|||percentage of participants||95% Confidence Interval|Number
719297|NCT00296335|Primary|Relapse-free Survival Rate|"Relapse-free survival at 3 years was defined as the proportion of patients who did not show an evidence of disease recurrence after 3 years of surgery.
Relapse was defined as any new tumor lesion."|3 years|Intention-to treat population||percentage of participants||95% Confidence Interval|Number
719298|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB/ApoA-1 Ratio|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 weeks|||Correlation coefficient|||Number
719299|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB/ApoA-1 Ratio|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks|||Correlation coefficient|||Number
719300|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 weeks|||Correlation coefficient|||Number
719301|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks|||Correlation coefficient|||Number
719302|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and ApoA1|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 weeks|||Correlation coefficient|||Number
719303|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and ApoA1|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks|||Correlation coefficient|||Number
719304|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C/HDL-C Ratio|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 weeks|||Correlation coefficient|||Number
719305|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C/HDL-C Ratio|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks|||Correlation coefficient|||Number
719306|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C/HDL-C Ratio|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 weeks|||Correlation coefficient|||Number
719307|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C/HDL-C Ratio|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks|||Correlation coefficient|||Number
719308|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and TC/HDL-C Ratio|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 weeks|||Correlation coefficient|||Number
719309|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and TC/HDL-C Ratio|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks|||Correlation coefficient|||Number
719314|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and HDL-C|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks|||Correlation coefficient|||Number
719315|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and HDL-C|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks|||Correlation coefficient|||Number
719316|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks|||Correlation coefficient|||Number
719317|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks|||Correlation coefficient|||Number
719318|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and TC|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks|||Correlation coefficient|||Number
719319|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and TC|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks|||Correlation coefficient|||Number
719320|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB/ApoA-1 Ratio|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks|||Correlation coefficient|||Number
719321|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB/ApoA-1 Ratio|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks|||Correlation coefficient|||Number
719322|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks|||Correlation coefficient|||Number
719323|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks|||Correlation coefficient|||Number
719324|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoA-1|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks|||Correlation coefficient|||Number
719325|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoA-1|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks|||Correlation coefficient|||Number
719326|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C/HDL-C Ratio|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks|||Correlation coefficient|||Number
719327|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C/HDL-C Ratio|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks|||Correlation coefficient|||Number
719328|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C/HDL-C Ratio|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks|||Correlation coefficient|||Number
719329|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C/HDL-C Ratio|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks|||Correlation coefficient|||Number
719330|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC/HDL-C Ratio|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks|||Correlation coefficient|||Number
719331|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC/HDL-C Ratio|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks|||Correlation coefficient|||Number
719332|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TG|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks|||Correlation coefficient|||Number
719333|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TG|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks|||Correlation coefficient|||Number
719334|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks|||Correlation coefficient|||Number
719335|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks|||Correlation coefficient|||Number
719336|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and HDL-C|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks|||Correlation coefficient|||Number
719337|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and HDL-C|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks|||Correlation coefficient|||Number
719338|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks|||Correlation coefficient|||Number
719339|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks|||Correlation coefficient|||Number
719340|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks|||Correlation coefficient|||Number
719341|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks|||Correlation coefficient|||Number
719342|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoB/ApoA-1 Ratio|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks|||Correlation coefficient|||Number
719343|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoB/ApoA-1 Ratio|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks|||Correlation coefficient|||Number
719344|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoB|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks|||Correlation coefficient|||Number
719345|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Apolipoprotein B [ApoB]|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks|||Correlation coefficient|||Number
719346|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoA-1|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks|||Correlation coefficient|||Number
719347|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Apolipoprotein A-1 [ApoA-1]|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks|||Correlation coefficient|||Number
719348|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and nonHDL-C/HDL-C Ratio|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks|||Correlation coefficient|||Number
719349|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and nonHDL-C/HDL-C Ratio|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks|||Correlation coefficient|||Number
719350|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and LDL-C/HDL-C Ratio|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks|||Correlation coefficient|||Number
719351|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and LDL-C/HDL-C Ratio|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks|||Correlation coefficient|||Number
719352|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and TC/HDL-C Ratio|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks|||Correlation coefficient|||Number
719353|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and TC/HDL-C Ratio|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks|||Correlation coefficient|||Number
719354|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and TG|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks|||Correlation coefficient|||Number
719355|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Triglyceride [TG]|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks|||Correlation coefficient|||Number
719356|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and nonHDL-C|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks|||Correlation coefficient|||Number
719357|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Non-high Density Lipoprotein Cholesterol [nonHDL-C]|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks|||Correlation coefficient|||Number
719358|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and HDL-C|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks|||Correlation coefficient|||Number
719359|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and High Density Lipoprotein Cholesterol [HDL-C]|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks|||Correlation coefficient|||Number
719360|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and LDL-C|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks|||Correlation coefficient|||Number
719361|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Low Density Lipoprotein Cholesterol [LDL-C]|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks|||Correlation coefficient|||Number
719362|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio TC|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|Assessed at 52 Weeks|||Correlation coefficient|||Number
719363|NCT00296374|Secondary|Correlation Coefficient Urinary Protein/Creatinine Ratio and Total Cholesterol [TC] Indicating the Relationship Between Renal Effects and Lipid Changes|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52 (LOCF).|52 weeks|||Correlation coefficient|||Number
719364|NCT00296374|Secondary|Change From Baseline in eGFR at Week 52 [LOCF]||Assessed at Baseline and Week 52 [LOCF]|||mL/min||Standard Deviation|Mean
719365|NCT00296374|Secondary|Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 26||Assessed at Baseline and Week 26|||mL/min||Standard Deviation|Mean
719366|NCT00296374|Secondary|Urinary Albumin/Creatinine Ratio at Week 52 [LOCF]|Urinary albumin/creatinine ratio (mg/g) =urine albumin concentration (mg/dL)/ urine creatinine concentration (g/dL). Outcome measure is the ratio of Week 52 [LOCF] urine albumin/creatinine ratio over baseline urine albumin/creatinine ratio.|Assessed at Week 52 LOCF|||mg/g||95% Confidence Interval|Geometric Mean
719367|NCT00296374|Secondary|Urinary Albumin/Creatinine Ratio at Week 26|Urinary albumin/creatinine ratio (mg/g) =urine albumin concentration (mg/dL)/ urine creatinine concentration (g/dL). Outcome measure is the ratio of Week 26 urine albumin/creatinine ratio over baseline urine albumin/creatinine ratio.|Assessed at Week 26|||mg/g||95% Confidence Interval|Geometric Mean
719368|NCT00296374|Secondary|Urinary Protein/Creatinine Ratio at Week 26.|Urinary protein/creatinine ratio (mg/g) =urine protein concentration (mg/dL)/ urine creatinine concentration (g/dL). Outcome measure is the ratio of Week 26 urine protein/creatinine ratio over baseline urine protein/creatinine ratio.|Assessed at Week 26|||mg/g||95% Confidence Interval|Geometric Mean
719369|NCT00296374|Primary|Urinary Protein/Creatinine Ratio in Patients With Type 1 or 2 Diabetes.|Urinary protein/creatinine ratio (mg/g) =urine protein concentration (mg/dL)/ urine creatinine concentration (g/dL). Outcome measure is the ratio of Week 52 [LOCF] urine protein/creatinine ratio over baseline urine protein/creatinine ratio.|Assessed at Week 52, Last observation carried forward (LOCF)|||mg/g||95% Confidence Interval|Geometric Mean
719370|NCT00296400|Secondary|Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 52|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks|||Correlation coefficient|||Number
719371|NCT00296400|Secondary|Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 26|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks|||Correlation coefficient|||Number
719372|NCT00296400|Secondary|Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoB at Week 52|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks|||Correlation coefficient|||Number
719373|NCT00296400|Secondary|Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoB at Week 26|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks|||Correlation coefficient|||Number
719374|NCT00296400|Secondary|Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoA1 at Week 52|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks|||Correlation coefficient|||Number
719375|NCT00296400|Secondary|Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoA1 at Week 26|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks|||Correlation coefficient|||Number
719376|NCT00296400|Secondary|Correlation of Change From Baseline in eGFR With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 52|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks|||Correlation coefficient|||Number
719377|NCT00296400|Secondary|Correlation of Change From Baseline in eGFR With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 26|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks|||Correlation coefficient|||Number
719378|NCT00296400|Secondary|Correlation of Change From Baseline in eGFR With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 52|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks|||Correlation coefficient|||Number
719379|NCT00296400|Secondary|Correlation of Change From Baseline in eGFR With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 26|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks|||Correlation coefficient|||Number
719380|NCT00296400|Secondary|Correlation of Change From Baseline in eGFR With Percent Change From Baseline in TC/HDL-C Ratio at Week 52|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks|||Correlation coefficient|||Number
719381|NCT00296400|Secondary|Correlation of Change From Baseline in eGFR With Percent Change From Baseline in TC/HDL-C Ratio at Week 26|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks|||Correlation coefficient|||Number
719382|NCT00296400|Secondary|Correlation of Change From Baseline in eGFR With Percent Change From Baseline in TG|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks|||Correlation coefficient|||Number
719383|NCT00296400|Secondary|Correlation of Change From Baseline in eGFR With Percent Change From Baseline in TG at Week 26|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks|||Correlation coefficient|||Number
719384|NCT00296400|Secondary|Correlation of Change From Baseline in eGFR With Percent Change From Baseline in nonHDL-C at Week 52|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks|||Correlation coefficient|||Number
719385|NCT00296400|Secondary|Correlation of Change From Baseline in eGFR With Percent Change From Baseline in nonHDL-C at Week 26|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks|||Correlation coefficient|||Number
719386|NCT00296400|Secondary|Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in HDL-C at Week 52|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks|||Correlation coefficient|||Number
719387|NCT00296400|Secondary|Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in HDL-C at Week 26|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks|||Correlation coefficient|||Number
719388|NCT00296400|Secondary|Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in LDL-C at Week 52|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks|||Correlation coefficient|||Number
719389|NCT00296400|Secondary|Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in LDL-C at Week 26|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks|||Correlation coefficient|||Number
719390|NCT00296400|Secondary|Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in TC at Week 52|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks|||Correlation coefficient|||Number
719709|NCT00299975|Secondary|Blood Creatinine Level||Pre-treatment(Week2) & Post-treatment(Week10)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.||μmol/L||Standard Deviation|Mean
719391|NCT00296400|Secondary|Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in TC at Week 26|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks|||Correlation coefficient|||Number
719392|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 52|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks|||Correlation coefficient|||Number
719393|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 26|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks|||Correlation coefficient|||Number
719394|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoB at Week 52|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|52 weeks|||Correlation coefficient|||Number
719395|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoB at Week 26|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks|||Correlation coefficient|||Number
719396|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoA-1 at Week 52|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks|||Correlation coefficient|||Number
719397|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoA-1 at Week 26|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks|||Correlation coefficient|||Number
719398|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 52|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks|||Correlation coefficient|||Number
719399|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 26|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks|||Correlation coefficient|||Number
719400|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 52|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks|||Correlation coefficient|||Number
719401|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 26|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks|||Correlation coefficient|||Number
719402|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TC/HDL-C Ratio at Week 52|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks|||Correlation coefficient|||Number
719403|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TC/HDL-C Ratio at Week 26|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks|||Correlation coefficient|||Number
719404|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TG at Week 52|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks|||Correlation coefficient|||Number
719405|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TG at Week 26|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks|||Correlation coefficient|||Number
719406|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in nonHDL-C at Week 52|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks|||Correlation coefficient|||Number
719407|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in nonHDL-C at Week 26|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks|||Correlation coefficient|||Number
719408|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in HDL-C at Week 52|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks|||Correlation coefficient|||Number
719409|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in HDL-C at Week 26|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks|||Correlation coefficient|||Number
719410|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in LDL-C at Week 52|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks|||Correlation coefficient|||Number
719411|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in LDL-C at Week 26|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks|||Correlation coefficient|||Number
719412|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TC at Week 52|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks|||Correlation coefficient|||Number
719413|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TC at Week 26|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks|||Correlation coefficient|||Number
719414|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 52|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks|||Correlation coefficient|||Number
719415|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 26|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks|||Correlation coefficient|||Number
719416|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in ApoB at Week 52|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks|||Correlation coefficient|||Number
719417|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Apolipoprotein B [ApoB] at Week 26|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks|||Correlation coefficient|||Number
719418|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in ApoA-1 at Week 52|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks|||Correlation coefficient|||Number
719419|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Apolipoprotein A-1 [ApoA-1] at Week 26|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks|||Correlation coefficient|||Number
719420|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 52|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks|||Correlation coefficient|||Number
719421|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 26|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks|||Correlation coefficient|||Number
719422|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 52|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks|||Correlation coefficient|||Number
719423|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 26|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks|||Correlation coefficient|||Number
719424|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in TC/HDL-C Ratio at Week 52|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks|||Correlation coefficient|||Number
719425|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in TC/HDL-C Ratio at Week 26|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks|||Correlation coefficient|||Number
719426|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in TG at Week 52|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks|||Correlation coefficient|||Number
719427|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Triglyceride [TG] at Week 26|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks|||Correlation coefficient|||Number
719428|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in nonHDL-C at Week 52|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks|||Correlation coefficient|||Number
719429|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Non-high Density Lipoprotein Cholesterol [nonHDL-C] at Week 26|"Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.
)"|Baseline and 26 weeks|||Correlation coefficient|||Number
719430|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in HDL-C at Week 52|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks|||Correlation coefficient|||Number
719431|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in High Density Lipoprotein Cholesterol [HDL-C] at Week 26|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|26 weeks|||Correlation coefficient|||Number
719432|NCT00296400|Secondary|Correlation of Changes From Baseline inUrinary Protein/Creatinine Ratio With Percent Change From Baseline in LDL-C|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|52 weeks|||Correlation coefficient|||Number
719433|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 26|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks|||Correlation coefficient|||Number
719434|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Total Cholesterol [TC] at Week 52.|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|52 weeks|||Correlation coefficient|||Number
719435|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Total Cholesterol [TC] at Week 26.|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|baseline and 26 weeks|||Correlation coefficient|||Number
719436|NCT00296400|Secondary|Change From Baseline in eGFR at Week 52 [LOCF]|The change from baseline in eGFR at Week 52 [LOCF] is the Week 52 value or last observation carried forward minus baseline value.|Assessed at baseline and Week 52 [LOCF]|||mL/min||Standard Deviation|Mean
719437|NCT00296400|Secondary|Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 26|The change from baseline in eGFR at Week 26 is the Week 26 value minus baseline value.|Assessed at baseline and Week 26|||mL/min||Standard Deviation|Mean
719438|NCT00296400|Secondary|Urinary Albumin/Creatinine Ratio at Week 52 [LOCF]|Urinary albumin/creatinine ratio (mg/g) =urine albumin concentration (mg/dL)/ urine creatinine concentration (g/dL). Outcome measure is the ratio of Week 52 [LOCF] urine albumin/creatinine ratio over baseline urine albumin/creatinine ratio.|Assessed at baseline and Week 52 [LOCF]|||ratio||95% Confidence Interval|Geometric Mean
719439|NCT00296400|Secondary|Urinary Albumin/Creatinine Ratio at Week 26|Urinary albumin/creatinine ratio (mg/g) =urine albumin concentration (mg/dL)/ urine creatinine concentration (g/dL). Outcome measure is the ratio of Week 26 urine albumin/creatinine ratio over baseline urine albumin/creatinine ratio.|Assessed at baseline and Week 26|||ratio||95% Confidence Interval|Geometric Mean
719440|NCT00296400|Secondary|Urinary Protein/Creatinine Ratio at Week 26.|Urinary protein/creatinine ratio (mg/g) =urine protein concentration (mg/dL)/ urine creatinine concentration (g/dL). Outcome measure is the ratio of Week 26 urine protein/creatinine ratio over baseline urine protein/creatinine ratio.|Assessed at baseline and Week 26|||ratio||95% Confidence Interval|Geometric Mean
719441|NCT00296400|Primary|Urinary Protein/Creatinine Ratio at Week 52 [LOCF]|Urinary protein/creatinine ratio (mg/g) =urine protein concentration (mg/dL)/ urine creatinine concentration (g/dL). Outcome measure is the ratio of Week 52 [LOCF] urine protein/creatinine ratio over baseline urine protein/creatinine ratio.|Assessed at baseline and Week 52 (LOCF)|||ratio||95% Confidence Interval|Geometric Mean
719442|NCT00296491|Secondary|Asthma: Mean Change From Baseline at Endpoint in Percentage of Albuterol/Salbutamol-Free Days for Per Protocol Population|Endpoint was defined as the average of the data reported from the last week of treatment. Albuterol/salbutamol use (related to percentage of asthma rescue-free days).|Baseline to Endpoint (weeks 3-4)|The Per Protocol population, the basis for equivalence comparison between FSC and FSC+MON in terms of asthma measures, included subjects from the ITT population who did not deviate significantly from the protocol. Families of secondary efficacy measures were each adjusted for multiplicity using Hochberg's method.||Percentage of rescue-free days||Standard Error|Mean
719443|NCT00296491|Secondary|Asthma: Mean Change From Baseline at Endpoint in Percentage of Albuterol-Salbutamol Free Days for Intent-to-Treat Population|Endpoint was defined as the average of the data reported from the last week of treatment. Albuterol/salbutamol use (related to percentage of asthma rescue-free days).|Baseline to Endpoint (weeks 3-4)|The Intent-to-Treat (ITT) population, the basis for superiority comparisons between FSC and MON in the context of asthma measures, included all subjects randomized to double-blind treatment. Families of secondary efficacy measures were each adjusted for multiplicity using Hochberg's method.||Percentage of rescue-free days||Standard Error|Mean
719486|NCT00296816|Secondary|Median Overall Survival Time|"Survival was the observed length of life from entry into the study to death or the date of last contact.
The median overall survival time was estimated using Kaplan-Meier Curve."|up to approximately 1700 days after treatment initiation|Intent-to-treat population - All participants who received study drugs, except for participants from one site which was closed prematurely, and for whom efficacy data was not available.||days||90% Confidence Interval|Median
719444|NCT00296491|Secondary|Asthma: Mean Change From Baseline at Endpoint in Percentage of Asthma Symptom-Free Days for Per Protocol Population|Asthma symptom score:0=no symptoms,1=symptoms 1 short period,2=symptoms 2 or more short periods,3=symptoms most of day not affect activities,4=symptoms most of day did affect activities,5=symptoms severe.Overall satisfaction score:0=very dissatisfied,1=dissatisfied,2=slightly dissatisfied,3=neutral,4=slightly satisfied,5=satisfied 6=very satisfied|Baseline to Endpoint (weeks 3-4)|The Per Protocol population, the basis for equivalence comparison between FSC and FSC+MON in terms of asthma measures, included subjects from the ITT population who did not deviate significantly from the protocol. Families of secondary efficacy measures were each adjusted for multiplicity using Hochberg's method.||Percentage of asthma symptom-free days||Standard Error|Mean
719445|NCT00296491|Secondary|Asthma: Mean Change From Baseline at Endpoint in Percentage of Asthma Symptom-Free Days for Intent-to-Treat Population|Endpoint was defined as the average of the data reported from the last week of treatment.Asthma symptom scores and the subject-rated overall satisfaction with treatment, related to the percentage of asthma symptom-free days. Same scale used as in outcome 8.|Baseline to Endpoint (weeks 3-4)|The Intent-to-Treat (ITT) population, the basis for superiority comparisons between FSC and MON in the context of asthma measures, included all subjects randomized to double-blind treatment. Families of secondary efficacy measures were each adjusted for multiplicity using Hochberg's method.||Percentage of asthma symptom-free days||Standard Error|Mean
719446|NCT00296491|Secondary|Asthma: Mean Change From Baseline at Endpoint in Predose Morning Forced Expiratory Volume (FEV1) for Per Protocol Population|Endpoint was defined as the average of the last week's worth of evaluable data. The volume of air that can be forced out taking a deep breath, an important measure of pulmonary function. FEV1 is forced expiratory volume in one second.|Baseline to Endpoint (weeks 3-4)|The Per Protocol population, the basis for equivalence comparison between FSC and FSC+MON in terms of asthma measures, included subjects from the ITT population who did not deviate significantly from the protocol. Families of secondary efficacy measures were each adjusted for multiplicity using Hochberg's method.||L/sec||Standard Error|Mean
719447|NCT00296491|Secondary|Asthma: Mean Change From Baseline at Endpoint in Predose Morning Forced Expiratory Volume (FEV1) for Intent-to-Treat Population|Endpoint was defined as the average of the last week's worth of evaluable data. The volume of air that can be forced out taking a deep breath, an important measure of pulmonary function. FEV1 is forced expiratory volume in one second.|Baseline to Endpoint (weeks 3-4)|The Intent-to-Treat (ITT) population, the basis for superiority comparisons between FSC and MON in the context of asthma measures, included all subjects randomized to double-blind treatment. Families of secondary efficacy measures were each adjusted for multiplicity using Hochberg's method.||L/sec||Standard Error|Mean
719448|NCT00296491|Secondary|Rhinitis: Mean Change From Baseline at 1-2 Weeks in Nightime Total Nasal Symptom Scores (N-TNSS)|The scores of 3 nighttime symptoms (nasal congestion upon awakening, difficulty going to sleep due to nasal symptoms, nighttime awakenings due to nasal symptoms). Scale: 0=not noticeable, 1=noticeable but not bothersome, 2=noticeable and bothersome some of the time, 3=bothersome most of the time and/or very bothersome some of the time.|Baseline To 1-2 Weeks|The Intent-to-Treat (ITT) population, the basis for superiority comparisons between FSC+FPANS and FSC+MON in the context of rhinitis measures, included all subjects randomized to double-blind treatment. Families of secondary efficacy measures were each adjusted for multiplicity using Hochberg's method.||Points on a Scale||Standard Error|Mean
719449|NCT00296491|Secondary|Rhinitis: Mean Change From Baseline at 1-2 Weeks in Daytime Total Nasal Symptom Scores (D-TNNS).|The sum of scores of each of the four daytime symptoms (nasal congestion, itching, rhinorrhea, and sneezing). Scale: 0=none (no sign/symptom evident)1=mild (sign/symptom clearly present; easily tolerated)2=moderate (definite awareness of sign/symptom that is bothersome but tolerable)3=severe (sign/symptom is hard to tolerate)|Baseline to 1-2 Weeks|The Intent-to-Treat (ITT) population, the basis for superiority comparisons between FSC+FPANS and FSC+MON in the context of rhinitis measures, included all subjects randomized to double-blind treatment. Families of secondary efficacy measures were each adjusted for multiplicity using Hochberg's method.||Points on a Scale||Standard Error|Mean
719450|NCT00296491|Primary|Mean Change From Baseline at Endpoint in Morning Peak Expiratory Flow (PEF) for Per Protocol Population|Endpoint was defined as the average of the data reported from the last week of treatment. Data collected by patient throughout the treatment period between visits. The peak expiratory flow rate measures how fast a person can breathe out (exhale) air. It is one of many tests that measure how well your airways work.|Baseline to Endpoint (weeks 3-4)|The Per Protocol population, the basis for equivalence comparison between FSC and FSC+MON in terms of asthma measures, included subjects from the ITT population who did not deviate significantly from the protocol.||L/min||Standard Error|Mean
719451|NCT00296491|Primary|Mean Change From Baseline at Endpoint in Morning Peak Expiration Flow (PEF) for Intent-to-Treat Population|Endpoint was defined as the average of the data reported from the last week of treatment. Data collected by patient throughout the treatment period between visits. The peak expiratory flow rate measures how fast a person can breathe out (exhale) air. It is one of many tests that measure how well your airways work.|Baseline to Endpoint (weeks 3-4)|The Intent-to-Treat (ITT) population, the basis for superiority comparisons between FSC and MON in the context of asthma measures, included all subjects randomized to double-blind treatment.||L/min||Standard Error|Mean
719452|NCT00296504|Secondary|Number of Participants Enrolled in Study APV30003 and Other Studies With the Indicated HIV-associated Conditions|The number of participants with the indicated HIV-associated conditions were assessed.|Baseline (Day 1) up to 31 January 2006 (up to Week 264)|All participants receiving FPV/RTV in Study APV30005 having previously participated in Study APV30003 or other studies.||participants|||Number
719453|NCT00296504|Secondary|Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions|The number of participants with the indicated HIV-associated conditions were assessed, excluding recurrences.|Baseline (Day 1) up to 31 January 2006 (up to Week 264)|All participants receiving FPV or NFV in Studies APV30001 and APV30002.||participants|||Number
719487|NCT00296816|Secondary|Overall Survival Rate|"Survival was the observed length of life from entry into the study to death or the date of last contact.
The overall survival rate (percentage of participants showing survival) at 12 and 24-months is reported here."|up to up to approximately 1700 days after treatment initiation|Intent-to-treat population - All participants who received study drugs, except for participants from one site which was closed prematurely, and for whom efficacy data was not available.||percentage of participants||95% Confidence Interval|Number
719454|NCT00296504|Secondary|Number of Participants With HIV-1 Disease Progression to CDC Class C, or New CDC Class C or Death, From Baseline|The number of participants with progression of HIV-1 disease were assessed using the CDC classification of HIV-1: class A, asymptomatic or lymphadenopathy; class B: symptomatic, but not AIDS; class C, AIDS. A participant is considered to have had a disease progression if they report a CDC Class C event for the first time, if they report a new CDC Class C event, or if they experience any fatal adverse event during the study.|Baseline (Day 1) up to 31 January 2006 (up to Week 264)|All participants receiving at least one dose of FPV or FPV/RTV in Study APV30005.||participants|||Number
719455|NCT00296504|Secondary|Median Plasma HIV-1 RNA at Weeks 180, 240, 300, 360, 420, and 432|Blood samples of participants were collected for the assessment of plasma HIV-1 RNA.|Weeks 180, 240, 300, 360, 420, and 432|All participants who remained in the study after January 31, 2006. Only those participants contributing data at the indicated time points were analyzed.||log 10 copies per milliliters||Full Range|Median
719456|NCT00296504|Secondary|Median Plasma HIV-1 RNA at Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168|Blood samples of participants were collected for the assessment of plasma HIV-1 RNA.|Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168|All participants receiving FPV or FPV/RTV in Study APV30005 having previously participated in Study APV30003 or other studies. Only those participants contributing data at the indicated time points were analyzed. The PI naïve and PI-experienced populations (other studies) had received antiretroviral therapy prior to Baseline.||log 10 copies per milliliter||Full Range|Median
719457|NCT00296504|Secondary|Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216|Blood samples of participants were collected for the assessment of plasma HIV-1 RNA.|Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216|All participants receiving FPV or FPV/RTV in Study APV30005 having previously particpated in Study APV30001 or Study APV30002. Only those participants contributing data at the indicated time points were analyzed. Participants in the NFV populations had received antiretroviral therapy prior to Baseline.||log 10 copies per milliliter||Full Range|Median
719458|NCT00296504|Secondary|Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 24, 48, 96, 132, and 168: Observed Analysis|Blood samples of participants were collected for the assessment of CD4+ cell count. CD4+ cells are white blood cells that are important in fighting infection. HIV infects CD4+ cells, replicates in them, and destroys them. CD4+ cell count provides a measure of the status of the immune system and to what extent it is affected by HIV.|Baseline and Weeks 24, 48, 96, 132, and 168|All participants receiving FPV or FPV/RTV in Study APV30005 having previously participated in Study APV30003 and other studies. Only those participants contributing data at the indicated time points were analyzed. The PI-naїve and PI-experienced populations (other studies) had received antiretroviral therapy prior to Baseline.||cells per millimeters cubed (cells/mm^3)||Full Range|Median
719459|NCT00296504|Secondary|Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 48, 120, 168, 180, 204, and 216: Observed Analysis|Blood samples of participants were collected for the assessment of CD4+ cell count. CD4+ cells are white blood cells that are important in fighting infection. HIV infects CD4+ cells, replicates in them, and destroys them. CD4+ cell count provides a measure of the status of the immune system and to what extent it is affected by HIV.|Baseline and Weeks 48, 120, 168, 180, 204, and 216|All participants receiving FPV or FPV/RTV in Study APV30005 having previously participated in Study APV30001 or Study APV30002. Only those participants contributing data at the indicated time points were analyzed. Participants in the NFV populations had received antiretroviral therapy prior to Baseline.||cells per millimeters cubed (cells/mm^3)||Full Range|Median
719460|NCT00296504|Secondary|Percentage of Participants With Plasma HIV-1RNA <50 Copies Per Milliliter at Baseline and Weeks 120, 180, 240, 300, 360, 420, and 432 (Observed)|Blood samples of participants were collected for the assessment of HIV-1RNA copies in plasma. Viral load, measured in RNA copies per milliliter of plasma,is an efficacy measure for antiretroviral drugs.|Baseline and Weeks 120, 180, 240, 300, 360, 420, and 432|All participants who remained in the study after January 31, 2006. Only those participants contributing data at the indicated time points were analyzed. In the observed analysis, data are presented for the number of participants still enrolled in the study who are classified as responders.||percentage of participants|||Number
719461|NCT00296504|Secondary|Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed)|Blood samples of participants were collected for the assessment of HIV-1RNA copies in plasma. Viral load, measured in RNA copies per milliliter of plasma, is an efficacy measure for antiretroviral drugs. In the MD=F analysis, participants who had missing data at or had discontinued the study prior to a certain time point are classified as non-responders. In the observed analysis (OA), data are presented for the number of participants still enrolled in the study at a certain time point.|Baseline and Weeks 12, 24, 48, 60, 96, and 132|All participants receiving FPV or FPV/RTV in Study APV3005 having participated in Study APV30003 or other studies. The PI-naïve and PI-experienced populations (other studies) had received antiretroviral therapy prior to Baseline.||percentage of participants|||Number
719462|NCT00296504|Secondary|Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed)|Blood samples of participants were collected for the assessment of HIV-1RNA copies in plasma. Viral load, measured in RNA copies per milliliter of plasma, is an efficacy measure for antiretroviral drugs. In the MD=F analysis, participants who had missing data at or had discontinued the study prior to a certain time point are classified as non-responders. In the observed analysis (OA), data are presented for the number of participants still enrolled in the study at a certain time point. Participants in the NFV populations had received antiretroviral therapy prior to Baseline.|Baseline and Weeks 48, 120, 180, and 216|All participants receiving FPV or FPV/RTV in Study APV30005 having previously participated in Study APV30001 or Study APV30002. No participants were analyzed in the NPV APV30001 arm due to their small number.||percentage of participants|||Number
719463|NCT00296504|Primary|Median Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase Values at Weeks 120, 180, 204, 216, and 432|Blood samples of participants were collected for the assessment of AST, ALT, and serum lipase.|Weeks 120, 180, 204, 216, and 432|All participants who remained in the study after January 31, 2006. Only those participants contributing data at the indicated time points were analyzed.||units per liter (U/L)||Inter-Quartile Range|Median
719464|NCT00296504|Primary|Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168|Blood samples of participants were collected for the assessment of AST, ALT, and serum lipase. Change from Baseline at Weeks 48, 96, 132, and 168 was calculated as the value at that particular week minus the value at Baseline (Day 1).|Baseline (Day 1) and Weeks 48, 96, 132, and 168|All participants receiving FPV or FPV/RTV in Study APV30005 having previously participated in Study APV30003 or other studies. Only those participants contributing data at the indicated time points were analyzed.||units per liter (U/L)||Inter-Quartile Range|Median
719465|NCT00296504|Primary|Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216|Blood samples of participants were collected for the assessment of AST, ALT, and serum lipase. Change from Baseline at Weeks 48, 120, 180, 204, and 216 was calculated as the value at that particular week minus the value at Baseline (Day 1).|Baseline (Day 1) and Weeks 48, 120, 180, 204, and 216|All participants receiving FPV or FPV/RTV in Study APV30005 having previously participated in Study APV30001 or Study APV30002. Only those participants contributing data at the indicated time points were analyzed.||units per liter (U/L)||Inter-Quartile Range|Median
719466|NCT00296504|Primary|Median Value of the Total Cholesterol/HDL Ratio at Weeks 120, 180, 204, 216, and 432|Fasting blood samples of participants were collected for the assessment of the total cholesterol/HDL ratio. The ratio of total cholesterol/HDL was calculated by dividing the value of total cholesterol by the value of HDL.|Weeks 120, 180, 204, 216, and 432|All participants who remained in the study after January 31, 2006. Only those participants contributing data at the indicated time points were analyzed.||ratio||Inter-Quartile Range|Median
719467|NCT00296504|Primary|Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 96, 132, and 168|Fasting blood samples of participants were collected for the assessment of the total cholesterol/HDL ratio. The ratio of total cholesterol/HDL was calculated by dividing the value of total cholesterol by the value of HDL. Change from Baseline at Weeks 48, 96, 132, and 168 was calculated as the value at that particular week minus the value at Baseline (Day 1).|Baseline (Day 1) and Weeks 48, 96, 132, and 168|All participants receiving FPV or FPV/RTV in Study APV30005 having previously participated in Study APV30003 or other studies. Only those participants contributing data at the indicated time points were analyzed.||ratio||Inter-Quartile Range|Median
719468|NCT00296504|Primary|Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 120, 180, 204, and 216|blood samples of participants were collected for the assessment of the total cholesterol/HDL ratio. The ratio of total cholesterol/HDL was calculated by dividing the value of total cholesterol by the value of HDL. Change from Baseline at Weeks 48, 120, 180, 204, and 216 was calculated as the value at that particular week minus the value at Baseline (Day 1).|Baseline (Day 1) and Weeks 48, 120, 180, 204, and 216|All participants receiving FPV or FPV/RTV in Study APV30005 having previously participated in Study APV30001 or Study APV30002. Only those participants contributing data at the indicated time points were analyzed.||ratio||Inter-Quartile Range|Median
719469|NCT00296504|Primary|Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432|Fasting blood samples of participants were collected for the assessment of triglycerides, cholesterol, high density cholesterol (HDL), low density cholesterol (LDL), and fasting blood glucose (FBG).|Weeks 120, 180, 204, 216, and 432|All participants who remained in the study after January 31, 2006. Only those participants contributing data at the indicated time points were analyzed.||milligrams per deciliter (mg/dl)||Inter-Quartile Range|Median
719470|NCT00296504|Primary|Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216|Fasting blood samples of participants were collected for the assessment of triglycerides (Tri.), cholesterol (Chol.), high density cholesterol (HDL), low density cholesterol (LDL), and fasting blood glucose (FBG). Change from Baseline at Weeks (W) 48, 96, 120, 132, 168, 180, 204, and 216 was calculated as the value at that particular week minus the value at Baseline (Day 1).|Baseline (Day 1) and Weeks 48, 96, 120, 132, 168, 180, 204, and 216|All participants receiving at least one dose of FPV or FPV/RTV in Study APV30005. Only those participants contributing data at the indicated time points were analyzed.||milligrams per deciliter (mg/dl)||Inter-Quartile Range|Median
719471|NCT00296504|Primary|Number of Participants With Any Adverse Event (AE): Final Analysis|"An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A list of all adverse events is reported in the Other (Non-Serious) Adverse Events section."|Post January 2006; for up to 241 weeks|All participants who remained in the study after January 31, 2006.||participants|||Number
719472|NCT00296504|Primary|Number of Participants With Any Adverse Event (AE): Interim Analysis|"An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A list of all adverse events is reported in the Other (Non-Serious) Adverse Events section."|Baseline (Day 1) up to 31 January 2006 (up to Week 264)|All participants receiving at least one dose of FPV or FPV/RTV in Study APV30005.||participants|||Number
719473|NCT00296517|Secondary|Safety: Adverse Events by Organ System Class, Intensity, and Frequency|Assessment of intensity was based on investigators/subinvestigator's clinical judgement per protocol instructions: Mild event, easily tolerated, with minimal discomfort and not interfering with Activities of Daily Living (ADLs); moderate event, with discomfort that interferes with ADLs; severe event, prevents ADLs.|Baseline to Week 12|Safety population: comprised of participants who took at least one dose of the treatment period investigational product. The number of participants analyzed for this outcome measure represents the total number of events at each intensity.||Number of events|||Number
719474|NCT00296517|Secondary|Study Continuation Rate as Assessed by the Number of Participants at Risk at Week 12|Kaplan-Meier estimates were calculated using event or censoring and time to event or censoring. Participants at risk refers to participants with either a censoring or event time beyond the time point of interest (Week 12).|Week 12|Full analysis set. Participants at risk refers to participants with either a censoring or event time beyond the time point of interest (Week 12).||participants|||Number
719523|NCT00297115|Secondary|Post-bronchodilator FEV1 [L]|Mean change from baseline during the treatment period in post-bronchodilator FEV1 [L]|Change from baseline over 52 weeks of treatment|ITT analysis. Number of participants analyzed = number of participants with data available.||mL||Standard Error|Least Squares Mean
719475|NCT00296517|Secondary|Percentage of Responders Based on the Clinical Global Impression - Global Improvement (CGI-I) Scale at Weeks 8 and 12|The CGI-I assesses the investigator's impression of the patient's current illness. The time span is the week before the rating and the score ranges from 1 (very much improved) to 7 (very much worse). Responders are subjects that have a score of 1 (very much improved) or 2 (much improved) on the CGI-I.|Baseline to Week 8 and Week 12|Full Analysis set. Week 8 Last Observation Carried Forward: placebo = 153, Bupropion = 159; Week 8 Observed Cases: placebo = 113, Bupropion = 106; Week 12 Last Observation Carried Forward: placebo = 156, Bupropion = 158; Week 12 Observed Cases: placebo = 111, Bupropion = 98||Percentage of Responders||95% Confidence Interval|Mean
719476|NCT00296517|Secondary|Change From Baseline in Clinical Global Impressions - Severity of Illness (CGI-S) Scale at Weeks 1, 2, 3, 4, and 8 and 12|The 7-point Clinical Global Impressions–Severity of Illness Scale (CGI-S) measures the severity of psychiatric symptoms. The following scores can be given: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill patients.|Baseline to Weeks 1, 2, 3, 4, 8, and 12|Full Analysis Set||Points on scale||Standard Deviation|Mean
719477|NCT00296517|Secondary|Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12|The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2, with total HAM-D scores ranging from 0 (not ill) to 54 (severely ill).|Baseline to Week 8 and Week 12|Full Analysis Set. Last Observation Carried Forward, LOCF; Gastrointestinal, GI; Somatic, Som.; General, Gen.; Week, W.||percent change in score||Standard Deviation|Mean
719478|NCT00296517|Secondary|Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12|The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2, with total HAM-D scores ranging from 0 (not ill) to 54 (severely ill).|Baseline to Week 8 and Week 12|Full Analysis Set. Week 8 Last Observation Carried Forward (LOCF): placebo=152, Bupropion=160; Week 12 LOCF: placebo=155, Bupropion=160. Gastrointestinal, GI.||points on a scale||Standard Deviation|Mean
719479|NCT00296517|Secondary|Percentage of Remitters Based on Hamilton Depression (HAM-D 17 Items) Scale Total Score at Weeks 8 and 12|The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM-D score range from 0 (not ill) to 52 (severely ill). Remitters are defined as subjects with HAM-D total score ≤ 7.|Baseline to Week 8 and Week 12|Full Analysis Set. Week 8 Last Observation Carried Forward: placebo = 152, Bupropion = 160, Week 8 Observed Cases: placebo = 113, Bupropion = 106, Week 12 Last Observation Carried Forward: placebo = 155, Bupropion = 160 Week 12 Observed Cases: placebo = 111, Bupropion = 98||Percentage of Remitters||95% Confidence Interval|Mean
719480|NCT00296517|Secondary|Percentage of Responders Based on Hamilton Depression (HAM-D 17 Items) Scale Total Score at Weeks 8 and 12|The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM-D score range from 0 (not ill) to 52 (severely ill). Responders are defined as subjects with 50% or greater reduction from baseline in HAM-D total score.|Baseline to Week 8 and Week 12|Full Analysis Set. Week 8 Last Observation Carried Forward: placebo = 152, Bupropion = 160, Week 8 Observed Cases: placebo = 113, Bupropion = 106, Week 12 Last Observation Carried Forward: placebo = 155, Bupropion = 160, Week 12 Observed Cases: placebo = 111, Bupropion = 98||Percentage of Responders||95% Confidence Interval|Mean
719481|NCT00296517|Secondary|Percentage of Change From Baseline of the Hamilton Depression (HAM-D 17 Items) Total Score at Weeks 8 and 12.|The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM-D score range from 0 (not ill) to 52 (severely ill).|Baseline to Week 8 and Week 12|Full Analysis Set. Week 8 Last Observation Carried Forward: placebo = 152, Bupropion = 160, Week 8 Observed Cases: placebo = 113, Bupropion = 106, Week 12 Last Observation Carried Forward: placebo = 155, Bupropion = 160 Week 12 Observed Cases: placebo = 111, Bupropion = 98||Percent Change in score||Standard Deviation|Mean
719482|NCT00296517|Secondary|Change From Baseline in the Hamilton Depression Scale (HAM-D 17 Items) Total Score at Week 8 and Total Score at Week 12|The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM-D score range from 0 (not ill) to 52 (severely ill).|Baseline to Week 8 and Week 12|Full Analysis Set. Week 8 Last Observation Carried Forward: placebo = 152, Bupropion = 160, Week 8 Observed Cases: placebo = 113, Bupropion = 106, Week 12 Observed Cases: placebo = 111, Bupropion = 98||Score in a scale||Standard Deviation|Mean
719483|NCT00296517|Secondary|Hamilton Depression Scale (HAM-D 17 Items) Total Score|The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM-D score range from 0 (not ill) to 52 (severely ill).|Week 8 and Week 12|Full Analysis Set. Week 8 Last Observation Carried Forward: placebo = 152, Bupropion = 160, Week 8 Observed Cases: placebo = 113, Bupropion = 106, Week 12 Observed Cases: placebo = 111, Bupropion = 98||Score in scale||Standard Deviation|Mean
719484|NCT00296517|Primary|Change From Baseline in the Hamilton Depression Scale (HAM-D 17 Items) Total Score|The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM-D score range from 0 (not ill) to 52 (severely ill).|Baseline and Week 12|Full Analysis Set was all subjects who entered the treatment phase with the exception of those who did not take any investigational products during the treatment phase and those who did not meet the major eligibility criteria of Major Depressive Disorder or those with no valid post baseline assessment. Week 12/LOCF placebo = 155, Bupropion SR = 160||Score in scale||Standard Deviation|Mean
719485|NCT00296647|Primary|6 Month Self-reported Abstinence From Smoking|Primary postquit outcomes was 7-day point prevalence abstinence (0, abstinent; 1, smoking) at 6 months (based on the week 24 interview)|6 months|intent to treat||participants|||Number
719573|NCT00298363|Secondary|Median Change in Model for End-Stage Liver Disease (MELD) Score From Baseline at Week 48|MELD scores, used to assess prognosis and suitability for transplant, are calculated based on laboratory values only and can range from 6 to 40, with higher scores indicating greater disease severity.|Baseline to Week 48|Subjects in the full analysis set with an available score at the visit||units on a scale||Inter-Quartile Range|Median
719488|NCT00296816|Secondary|CA-125 Response Rate|"A CA-125 response was considered at least a 50% reduction in the level of the biomarker, CA-125, from a pretreatment level, which was confirmed and maintained for at least 28 days.
The overall CA-125 biomarker response rate was defined as the number of participants in the measurable disease subgroup who met the above criteria at least once within the study treatment period +21 days, divided by the number of evaluable participants in the disease subgroup."|up to 12 months after treatment initiation|All participants with non-measurable and measurable disease at baseline, and a pretreatment sample that was at least twice the ULN value for CA-125 within 2 weeks of first study treatment.||percentage of participants||95% Confidence Interval|Number
719489|NCT00296816|Secondary|Median Time to Recurrence-free Survival (RFS) in Participants With Non-measurable Disease at Baseline|"The time to RFS was programmatically defined as the interval from the date of registration to the earliest date of disease progression or death, whichever occurred first.
Participants were
censored on the last available CA 125 biomarker blood draw date if
left the study prior to disease progression or death
they received off-study anti-tumor medication
underwent debulking surgery
censored at Day 1 if they were alive had no post baseline CA 125 biomarker blood draw."|up to approximately 1500 days following treatment initiation|All participants with non-measurable disease at baseline, except for those at one site that closed prematurely, as their data was not available for efficacy measures.||days||95% Confidence Interval|Median
719490|NCT00296816|Secondary|Twelve-month Recurrence-free Survival (RFS) Rate in Participants With Non Measurable Disease at Baseline|"Participants with Recurrence-free survival (RFS) were participants with a non-measurable disease at baseline, who had not achieved disease progression nor had died.
Disease progression included the following:
the appearance of a new lesion
symptomatic deterioration
progression of non-target lesions
a predefined serum CA 125 increase.
RFS rate was the percent of participants in the non-measurable disease subgroup who achieved RFS."|up to 12 months following treatment initiation|All participants with non-measurable disease at baseline, except for those at one site that closed prematurely, as their data was not available for efficacy measures.||percentage of participants||95% Confidence Interval|Number
719491|NCT00296816|Secondary|Tumor Response Rate Based on Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST)|"Tumors were assessed by CT and MRI. Tumor response was evaluated by GOG RECIST in which:
Complete response (CR) was the disappearance of all target and non-target lesions, with no evidence of new lesions
Partial response (PR) was at least a 30% decrease in the sum of longest dimensions (LD) of all measurable target lesions
Participants with a response (CR or PR) were to have the initial response confirmed by tumor imaging in 4-6 weeks."|up to 12 months following treatment initiation|Intent-to-treat population with measurable disease at baseline - All participants with measurable disease at baseline who received study drugs, except for participants from one site which was closed prematurely, and for whom efficacy data was not available.||participants|||Number
719492|NCT00296816|Secondary|Median Time to Progression-free Survival (PFS)|"Time to PFS was the interval from the date of registration to the earliest date of disease progression or death, whichever occurred first.
Time of PFS was censored
on the last available tumor assessment date for participants leaving the study prior to disease progression or death; and also for participants requiring off-study medication or additional debulking surgery (where assessment date used was the one prior to off-study medication or surgery),
at Day 1, for living participants with no post-baseline tumor assessments.
Median PFS was estimated from a Kaplan-Meier curve."|up to approximately 1300 days following treatment initiation|Intent-to-treat population with measurable disease at baseline - All participants with measurable disease at baseline who received study drugs, except for participants from one site which was closed prematurely, and for whom efficacy data was not available.||days||95% Confidence Interval|Median
719493|NCT00296816|Secondary|Twenty Four-month Progression-free Survival (PFS) Rate in Participants|"Tumor assessments were performed by Computed tomography (CT) and Magnetic Resonance Imaging (MRI) to evaluate disease progression based on Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST).
Disease progression was recorded as any one of the following:
appearance of a new lesion
symptomatic deterioration
progression of target or nontarget lesions
death
Participants who did not die or show show disease progression achieved PFS. PFS rate is the percent of participants who achieved PFS."|up to 24 months following treatment initiation|Intent-to-treat population with measurable disease at baseline - All participants with measurable disease at baseline who received study drugs, except for participants from one site which was closed prematurely, and for whom efficacy data was not available.||percentage of participants||95% Confidence Interval|Number
719494|NCT00296816|Primary|Twelve-month Progression-free Survival (PFS) Rate in Participants|"Tumor assessments were performed by Computed tomography (CT) and Magnetic Resonance Imaging (MRI) to evaluate disease progression based on Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST).
Disease progression was recorded as any one of the following:
appearance of a new lesion
symptomatic deterioration
progression of target or nontarget lesions
death
Participants who did not die or show show disease progression achieved PFS. PFS rate is the percent of participants who achieved PFS."|up to 12 months following treatment initiation|Intent-to-treat population with measurable disease at baseline - All participants with measurable disease at baseline who received study drugs, except for participants from one site which was closed prematurely, and for whom efficacy data was not available.||percentage of participants||95% Confidence Interval|Number
719495|NCT00297037|Secondary|The Secondary Efficacy Variable Was Change in the Size of a Target Erosion in Millimeters.|Secondary outcome variable was change in size of the target erosion in millimeters from baseline compared to week 6.|0, 1, 2, 4, 6 weeks|||mm||Full Range|Mean
719496|NCT00297037|Secondary|The Secondary Efficacy Variables Was Changes Erythema and Assessment of Spontaneous Pain on a Visual Analog Scale (0-10).|The secondary efficacy variables were change in the size of the target erosion, erythema and assessment of spontaneous pain on a visual analog scale (0-10). The scale used to measure erythema is 0-3. 0 is no erythema, 1 is mild erythema, 2 is moderate erythema, and 3 is severe erythema. Minimum score is 0. Maximum score is 3. Spontaneous pain was scored on a scale of 0-10 (0 no pain, 10 severe pain). Measurments were completed day 0, week 1, week 2, week 4, and week 6. Scores are listed at baseline (day 0) and end of study (week 6).|0, 1, 2, 4, 6 weeks|||units on a scale||Full Range|Mean
719710|NCT00299975|Secondary|Blood Urea Level||Pre-treatment(Week2) & Post-treatment(Week10)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.||mmol/L||Standard Deviation|Mean
719497|NCT00297037|Primary|The Primary Efficacy Variable Was the Change in the Investigator's Global Assessment of the Overall Severity of Disease From Baseline to Week 6.|The primary efficacy variable was the change in the Investigator's Global Assessment of the overall severity of disease from baseline to week 6. Scale is 0-4. 0 is no disease. 4 is worst disease. Minimum score is 0. Maximum score is 4. Measurments were completed day 0, week 1, week 2, week 4, and week 6. Scores are listed at baseline (day 0) and end of study (week 6).|0, 1, 2, 4, 6 weeks|ITT using last observation carried forward for missing data||units on a scale||Full Range|Mean
719498|NCT00288054|Secondary|Response Rate|Confirmed and unconfirmed complete and partial responses in the subset of patients with measurable disease (as defined per RECIST). A confirmed complete response (CR) is defined as disappearance of all disease, confirmed by a second determination of CR at least 4 weeks later. A confirmed partial response (PR) is defined as a >= 30% decrease from baseline in the sum of longest diameters, confirmed by a second determination of PR at least 4 weeks later. A patient is considered to have measurable disease if they have at least one lesion with a longest diameter of >= 2 cm by conventional CT, or >= 1 cm by spiral CT.|Week 10 and week 22|Eligible patients who began protocol treatment and who had measurable disease (as defined by RECIST) at baseline were included in the analysis.||percentage of participants||95% Confidence Interval|Number
719499|NCT00288054|Secondary|Progression-free Survival.|Duration from the date of enrollment until the date of progression (as defined by RECIST: >= 20% increase over baseline in the sum of longest diameters, or appearance of new lesions, or non-measurable disease that is clearly worsening in the opinion of the treating investigator, or symptomatic deterioration) or death due to any cause. Patients last known to be alive and free of disease progression are censored at the date of last contact.|At week 10, week 22, and then every 3 months until progression for up to 3 years after enrollment.|Eligible patients who began protocol treatment were included in the analysis.||months||95% Confidence Interval|Number
719500|NCT00288054|Secondary|Overall Survival|The duration form the date of enrollment until the date of death due to any cause. Patients last known to be alive are censored at the date of last contact.|weekly while patient is on protocol treatment, then monthly thereafter.|Eligible patients who began protocol treatment were included in the analysis.||months||95% Confidence Interval|Median
719501|NCT00288054|Primary|Treatment-related Esophagitis or Pneumonitis|The primary endpoint will be the rate of Grade 3 or greater esophagitis and/or pneumonitis within 4 months after discontinuation of radiation therapy.|Weekly for the first 8 weeks, then every 4 weeks thereafter for up to 4 months after complettion of radiotherapy.|Eligible patients who received protocol treatment were included in the analysis.||percentage of participants||95% Confidence Interval|Number
719502|NCT00288054|Secondary|Toxicity|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Weekly for the first 8 weeks, then every 4 weeks while subject on protocol treatment.|Eligible patients who received protocol treatment.||Participants|||Number
719503|NCT00288067|Primary|Response Rates of B-Non-Hodgkin Lymphoma to the Combination of Rituximab and Fenretinide (Phase II)|The trial was stratified into rituximab-naïve and rituximab pre-treated patients, and the target response rates for these groups were expected to be 30% and 10%, respectively. The numbers reported below are subjects who achieved a response of partial response or better.|Up to 7 years|No subjects in Phase 1 met the DLT, therefore Phase II was conducted at 900mg/m2. Of the 32 subjects, 4 subjects were not evaluable for disease response (2 subjects in Phase 1 and 2 subjects in Phase 2).||participants|||Number
719504|NCT00288067|Primary|Safety, in Terms of Dose-limiting Toxicity (DLT) of 2 Daily Doses of Single Agent Fenretinide (Phase I)|"A group of 3 patients would start treatment ast the dose of 900mg/m^2 BID, and if none of the 3 experienced a DLT, another 3 would then be treated at that dose. Dose Limiting Toxicity was defined as any related toxicity of grade 4 or 5 on or before the completion of 4 weeks of therapy.
Per response evaluation criteria 1999 Cheson Response Criteria for Malignant Lymphoma (CHESON99) for target lesions assessed by either CT or MRI:
Complete Response (CR): Complete disappearance of all measurable and non-measurable disease; Complete Response Unconfirmed (CRU): Complete disappearance of all measurable and non-measurable disease, with the exception of all residual nodal masses >1.5cm in Greatest Transverse Diameter (GTD) reduced by 75% in Sum of the Product of the greatest Diameters (SPD); Partial Response (PR): 50% decrease in the SPD."|Number of participants that experienced a dose-limiting toxicity|7 participants were analyzed in the Rituximab Naive arm and 16 participants were analyzed in the Rituximab Pre Treated Arm.||participants|||Number
719505|NCT00288080|Other Pre-specified|To Collect Paraffin-embedded Tissue Block, Serum, Plasma, and Buffy Coat Cells for Future Translational Research Analyses||From randomization to four years, any further data collected at time of analysis will be included.||||||
719506|NCT00288080|Secondary|Validity of PSA-defined Endpoints as a Surrogate for Overall Survival||From randomization to date of biochemical failure, death, or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years.||02/2018||||
719507|NCT00288080|Secondary|The Time Interval Between Biochemical Failure and Distant Metastases With Respect to Testosterone Level||From date of biochemical failure to development of distant failure. Analysis occurs after all patients have been potentially followed for 4 years.||02/2018||||
719508|NCT00288080|Secondary|Incidence of Adverse Events|Adverse events are graded using CTCAE v3.0. The worst grade of all adverse events for each patient is counted.|From start of treatment until the end of follow-up|Eligible patients who started protocol treatment and did not withdraw consent||percentage of participants|||Number
719509|NCT00288080|Secondary|Disease-free Survival|A failure for disease-free survival is the first of the following: biochemical failure, local failure, distant metastases, or death due to any cause. The corresponding outcome time was measured from the date of randomization. Disease-free survival rates at 4 years were calculated using the Kaplan-Meier method.|From randomization to date of progression, death, or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years.|Eligible patients who did not withdraw consent.||percentage of participants||95% Confidence Interval|Number
719569|NCT00298363|Secondary|Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss and HBeAg Seroconversion at Week 48 (for Participants Who Were HBeAg Positive at Baseline)|Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive.|Baseline to Week 48|Serologically evaluable analysis set (subjects in full analysis set with positive hepatitis B early antigen [HBeAg] at baseline); noncompleters/switch = failure||percentage of participants|||Number
719510|NCT00288080|Secondary|Distant Metastasis|Distant failure was considered when there was evidence of metastatic disease. Patients who experienced death without distant failure, local failure prior to distant failure, and biochemical failure prior to distant failure were censored on the date of the competing event. The corresponding outcome time was measured from the date of randomization. Distant failure rates at 4 year were calculated using the Kaplan-Meier method.|From randomization to date of distant metastasis, death, or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years.|Eligible patients who did not withdraw consent.||percentage of participants||95% Confidence Interval|Number
719511|NCT00288080|Secondary|Local Control|Local control is defined as the absence of local failure which is the first of either progression or recurrence within the prostate. Progression of the tumor was considered to have occurred when there was a 25% or greater increase in the product of the two largest perpendicular diameters of the prostate. Recurrence was defined as the reappearance of disease after a complete response. Patients who experienced death without local failure, biochemical failure prior to local failure, and development of distant metastases prior to local failure were censored on the date of the competing event. The corresponding outcome time was measured from the date of randomization. Due to an insufficient number of events (2 in each arm), this endpoint was not statistically compared. Local control rates at 4 years were calculated using the Kaplan-Meier method.|From randomization to date of local failure, death, or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years.|Eligible patients who did not withdraw consent||percentage of participants||95% Confidence Interval|Number
719512|NCT00288080|Secondary|Biochemical Control|Four-year rates are shown (Kaplan-Meier estimates). Biochemical control is defined as freedom from biochemical failure. Biochemical failure was considered as the first of either prostate-specific antigen (PSA) failure or initiation of salvage hormone therapy. PSA failure was defined as a rise of 2 ng/ml over the nadir PSA. Patients who experienced death without biochemical failure, local failure prior to biochemical failure, or development of distant metastases prior to biochemical failure were censored on the date of the competing event. The corresponding outcome time was measured from the date of randomization.|From randomization to date of biochemical failure, death, or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years.|Eligible patients who did not withdraw consent.||percentage of participants||95% Confidence Interval|Number
719513|NCT00288080|Primary|Overall Survival|Four-year rates are shown. Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.|From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years.|Eligible patients who did not withdraw consent.||percentage of participants||95% Confidence Interval|Number
719514|NCT00297102|Secondary|Mean Transition Dyspnea Index (TDI) Focal Score During the Treatment Period|The TDI is a recognized questionnaire to measure dyspnea in an out patient COPD population. At baseline, 3 components of dyspnea, each graded with 4 questions, were asked: - Functional Impairment - Magnitude of Task - Magnitude of Effort At each of the post-randomization visits questions from the TDI were asked related to 3 components: Change in - Functional Impairment - Magnitude of Task - Magnitude of Effort Each question in the TDI is graded from –3 (major deterioration) to +3 (major improvement). This results in a TDI Focal Score ranging from –9 to +9.|Change from baseline over 52 weeks of treatment|ITT analysis. Number of participants analyzed = number of participants with data available.||scores on a scale||Standard Error|Least Squares Mean
719515|NCT00297102|Secondary|Natural Log-transformed C-reactive Protein (CRP)|Mean change from baseline to the last post randomization measurement in natural log-transformed CRP|Change from baseline to last post randomization measurement (52 weeks)|ITT analysis. Number of participants analyzed = number of participants with data available.||mg/L||95% Confidence Interval|Least Squares Mean
719516|NCT00297102|Secondary|Time to Mortality Due to Any Reason||52 weeks treatment period|ITT analysis. Number of participants analyzed = number of participants who died.||days||Standard Deviation|Mean
719517|NCT00297102|Secondary|Post-bronchodilator FEV1 [L]|Mean change from baseline during the treatment period in post-bronchodilator FEV1 [L]|Change from baseline over 52 weeks of treatment|ITT analysis. Number of participants analyzed = number of participants with data available.||mL||Standard Error|Least Squares Mean
719518|NCT00297102|Primary|COPD Exacerbation Rate (Moderate or Severe)|Mean rate of COPD exacerbations requiring oral or parenteral glucocorticosteroids (=moderate COPD exacerbations), or requiring hospitalization, or leading to death (=severe COPD exacerbations), per patient per year. A COPD exacerbation is an event in the natural course of the disease characterized by a change in the patient’s baseline dyspnea, cough and/or sputum beyond day-to-day variability sufficient to warrant a change in management [American Thoracic Society (ATS) / European Respiratory Society (ERS) 2005].|52 weeks treatment period|ITT analysis.||exacerbations per patient per year||95% Confidence Interval|Mean
719519|NCT00297102|Primary|Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1)|Mean change from baseline during the treatment period in pre-bronchodilator FEV1 [L]|Change from baseline over 52 weeks of treatment|ITT (Intention to Treat) analysis. Number of participants analyzed = number of participants with data available.||mL||Standard Error|Least Squares Mean
719520|NCT00297115|Secondary|Mean Transition Dyspnea Index (TDI) Focal Score During the Treatment Period|The TDI is a recognized questionnaire to measure dyspnea in an out patient COPD population. At baseline, 3 components of dyspnea, each graded with 4 questions, were asked: - Functional Impairment - Magnitude of Task - Magnitude of Effort At each of the post-randomization visits questions from the TDI were asked related to 3 components: Change in - Functional Impairment - Magnitude of Task - Magnitude of Effort Each question in the TDI is graded from –3 (major deterioration) to +3 (major improvement). This results in a TDI Focal Score ranging from –9 to +9.|Change from baseline over 52 weeks of treatment|ITT analysis. Number of participants analyzed = number of participants with data available.||scores on a scale||Standard Error|Least Squares Mean
719521|NCT00297115|Secondary|Natural Log-transformed C-reactive Protein (CRP)|Mean change from baseline to the last post randomization measurement in natural log-transformed CRP|Change from baseline to last post randomization measurement (52 weeks)|ITT analysis. Number of participants analyzed = number of participants with data available.||mg/L||95% Confidence Interval|Least Squares Mean
719522|NCT00297115|Secondary|Time to Mortality Due to Any Reason||52 weeks treatment period|ITT analysis. Number of participants analyzed = number of participants who died.||days||Standard Deviation|Mean
719524|NCT00297115|Primary|COPD Exacerbation Rate (Moderate or Severe)|Mean rate of COPD exacerbations requiring oral or parenteral glucocorticosteroids (=moderate COPD exacerbations), or requiring hospitalization, or leading to death (=severe COPD exacerbations), per patient per year. A COPD exacerbation is an event in the natural course of the disease characterized by a change in the patient’s baseline dyspnea, cough and/or sputum beyond day-to-day variability sufficient to warrant a change in management [American Thoracic Society (ATS) / European Respiratory Society (ERS) 2005].|52 weeks treatment period|ITT analysis.||exacerbations per patient per year||95% Confidence Interval|Mean
719525|NCT00297115|Primary|Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1)|Mean change from baseline during the treatment period in pre-bronchodilator FEV1 [L]|Change from baseline over 52 weeks of treatment|ITT (Intention to Treat) analysis. Number of participants analyzed = number of participants with data available.||mL||Standard Error|Least Squares Mean
719526|NCT00297167|Other Pre-specified|Percentage of Stools With Blood|Mean percentage of stools with blood during the collection period (Day 3 to Day 6 in first and second intervention periods) for total participants was summarized. Percentage was calculated as the number of stools with blood divided by the total number of stool per day.|Day 3 up to Day 6 of hospital treatment in first and second double-blind intervention periods|Efficacy analysis population included all randomized and treated participants with at least 1 post-baseline measurement for each double-blind intervention period.||percentage of stools with blood per day||Standard Deviation|Mean
719527|NCT00297167|Other Pre-specified|Percentage of Visible Oil or Grease in Stool|Mean percentage of stools with visible oil or grease during the collection period (Day 3 to Day 6 in first and second intervention periods) for total participants was summarized. Percentage was calculated as the number of stools with visible oil or grease divided by the total number of stool per day.|Day 3 up to Day 6 of hospital treatment in first and second double-blind intervention periods|Efficacy analysis population included all randomized and treated participants with at least 1 post-baseline measurement for each double-blind intervention period.||percentage of visible oil or grease/day||Standard Deviation|Mean
719528|NCT00297167|Secondary|Mean Number of Abdominal Symptoms|Abdominal symptoms included abdominal pain, flatulence and bloating. Symptoms were classified by severity as mild (no impairment of daily activities), moderate (slight impairment of daily activities), or severe (unable to perform daily activities). Mean number of symptom of specific severity per day for each participant was calculated. Mean number of symptoms per day was calculated for Day 3 to Day 6 in first and second double-blind intervention periods for total participants.|Day 3 up to Day 6 during first and second double-blind intervention periods|Efficacy analysis population included all randomized and treated participants with at least 1 post-baseline measurement for each double-blind intervention period.||symptoms per day||Standard Deviation|Mean
719529|NCT00297167|Secondary|Percentage of Stool Categorized as Per Consistency|Stool consistency was categorized as hard, formed/normal, soft, watery, or overt diarrhea. Percentage of stools of a specific consistency for each participant at first and second double-blind intervention periods was calculated. Mean percentage of stool consistency during the collection period (Day 3 to Day 6 in first and second intervention periods) for total participants was summarized.|Day 3 up to Day 6 during first and second double-blind intervention periods|Efficacy analysis population included all randomized and treated participants with at least 1 post-baseline measurement for each double-blind intervention period.||percentage of stools||Standard Deviation|Mean
719530|NCT00297167|Secondary|Mean Daily Number of Stools|Mean daily number of stools of each participant was calculated from frequency of stools by the participant per day. Mean daily number of stools during the collection period (Day 3 to Day 6 in first and second double-blind intervention periods) for total participants was summarized.|Day 3 up to Day 6 during first and second double-blind intervention periods|Efficacy analysis population included all randomized and treated participants with at least 1 post-baseline measurement for each double-blind intervention period.||stools per day||Standard Deviation|Mean
719531|NCT00297167|Secondary|Vitamin E Levels|Mean Vitamin E levels for Day 6 during first and second double-blind intervention periods were calculated.|End of treatment (Day 6 during first and second double-blind intervention periods)|"Safety population included all participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure."||mg/L||Standard Deviation|Mean
719532|NCT00297167|Secondary|Vitamin A Levels|Mean Vitamin A levels for Day 6 during first and second double-blind intervention periods were calculated.|End of treatment (Day 6 during first and second double-blind intervention periods)|"Safety population included all participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure."||microgram per liter (mcg/L)||Standard Deviation|Mean
719533|NCT00297167|Secondary|Lipid Levels|Lipid levels were reported for total cholesterol (TC) and high-density lipoprotein cholesterol (HDL-C) from fasted blood and urine samples. Mean lipid levels for Day 6 during first and second double-blind intervention periods were calculated.|End of treatment (Day 6 during first and second double-blind intervention periods)|"Safety population included all participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and n signifies participants who were evaluable at specific time point in each treatment arm."||milligram/deciliter (mg/dL)||Standard Deviation|Mean
719534|NCT00297167|Secondary|Percent Coefficient of Nitrogen Absorption (CNA%)|Percent CNA was calculated as ([nitrogen intake-nitrogen excretion]/nitrogen intake)*100, determined in the stools collected during the 72-hour hospitalization period. Nitrogen intake was calculated as protein intake/6.2. Nitrogen excretion was measured as total fecal nitrogen. Mean percent CNA was calculated for Day 3 to Day 6 during hospital treatment in first and second double-blind intervention periods.|Day 3 up to Day 6 of hospital treatment in first and second double-blind intervention periods|"Efficacy analysis population included all randomized and treated participants with at least 1 post-baseline measurement for each double-blind intervention period. Here N (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure."||percent CNA||Standard Error|Least Squares Mean
719570|NCT00298363|Secondary|Median Change in MELD Score From Baseline at Week 168|MELD scores, used to assess prognosis and suitability for transplant, are calculated based on laboratory values only and can range from 6 to 40, with higher scores indicating greater disease severity.|Baseline to Week 168|Subjects in the full analysis set with an available score at the visit||units on a scale||Inter-Quartile Range|Median
719535|NCT00297167|Primary|Percent Coefficient of Fat Absorption (CFA%)|Percent CFA was calculated as ([fat intake - fat excretion]/fat intake)multiplied by 100, determined in the stools collected during the 72-hour hospitalization period. Mean percent CFA was calculated for Day 3 to Day 6 during hospital treatment in first and second double-blind (DB) intervention periods.|Day 3 up to Day 6 of hospital treatment in first and second double-blind intervention periods|"Efficacy analysis population included all randomized and treated participants with at least 1 post-baseline measurement for each double-blind intervention period. Here N (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure."||percent CFA||Standard Error|Least Squares Mean
719536|NCT00297232|Primary|Time to 24-week Confirmed EDSS Improvement Where Baseline ≥ 2.0|Time to 24-week confirmed EDSS improvement in subjects with at least 2 post-baseline milestone EDSS assessments. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was reported. Confirmed 24-week EDSS improvement is defined as ≥ 1.0 point decrease from baseline sustained for 24 weeks.|Up to 480 weeks|Participants with EDSS improvement (regardless of length of follow-up) sustained for 24 weeks.||weeks||Inter-Quartile Range|Median
719537|NCT00297232|Primary|Time to 48-week Confirmed EDSS Progression|Time to 48-week confirmed EDSS progression in particpants with at least 2 post-baseline milestone EDSS assessments. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was reported. Confirmed 48-week EDSS progression was defined as ≥ 0.5 point increase from a baseline EDSS ≥ 6.0, or ≥ 1.0 point increase from a baseline EDSS ≥ 1.0 and < 6.0, or ≥ 1.5 point increase from a baseline EDSS of 0, all sustained for 48 weeks.|up to 480 weeks|Participants with EDSS progression (regardless of length of follow-up) sustained for 48 weeks.||weeks||Inter-Quartile Range|Median
719538|NCT00297232|Primary|Time to 24-week Confirmed Expanded Disability Status Scale (EDSS) Progression|Time to 24-week confirmed EDSS progression in participants with at least 2 post-baseline milestone EDSS assessments. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was reported. Confirmed 24-week EDSS progression was defined as ≥ 0.5 point increase from a baseline EDSS ≥ 6.0, or ≥ 1.0 point increase from a baseline EDSS ≥ 1.0 and < 6.0, or ≥ 1.5 point increase from a baseline EDSS of 0, all sustained for 24 weeks.|up to 480 weeks|Participants with EDSS progression (regardless of length of follow-up) sustained for 24 weeks.||weeks||Inter-Quartile Range|Median
719539|NCT00297258|Secondary|Overall Response|Overall response is the number of participants who had a best outcome of a complete response (CR, all detectable tumor had disappeared) or a partial response (PR, a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum) per response evaluation criteria in solid tumors (RECIST v1.0) at some point during the study. Progressive disease (PD), a >=20% increase in target lesions. Clinical progression is progression of disease without documented radiological evidence.|Baseline until either response or progression (up to approximately 5 years)|Intent-to-Treat (ITT) Population: all eligible participants who had started therapy. Four participants were considered not evaluable for efficacy by the study coordinator for one of the following reasons: absence of target lesions, documented progression at trial entry, or ineligible histology.||participants|||Number
719540|NCT00297258|Secondary|Progression Free Survival|Progression free survival is defined as the interval between the start of treatment and the earliest date of disease progression or death due to any cause. Assessments of progression were made by the investigator.|Start of therapy until progression (up to approximately 5 years)|Intent-to-Treat (ITT) Population: all eligible participants who had started therapy. Four participants were considered not evaluable for efficacy by the study coordinator for one of the following reasons: absence of target lesions, documented progression at trial entry, or ineligible histology.||years||90% Confidence Interval|Median
719541|NCT00297258|Secondary|Overall Survival|Overall survival is defined as the time from start of therapy until death. Participants who were still alive at the time of analysis were censored.|Start of therapy until death (up to approximately 5 years)|ITT Population. Four participants were considered not evaluable for efficacy by the study coordinator for one of the following reasons: absence of target lesions, documented progression at trial entry, or ineligible histology.||years||90% Confidence Interval|Median
719542|NCT00297258|Primary|Progression Free Survival at Week 12|Progression free survival at week 12 is the number of participants who had a complete response (CR, all detectable tumor had disappeared) or a partial response (PR, a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum) or stable disease (SD, no change) 12 weeks from start of therapy, per response evaluation criteria in solid tumors (RECIST v1.0). Clinical progression is progression of disease without documented radiological evidence. Progressive disease (PD), a >=20% increase in target lesions.|Week 12|Intent-to-Treat (ITT) Population: All eligible participants entered into the study and who had taken >=1 dose of investigational product. Four participants were considered not evaluable for efficacy by the study coordinator for one of the following reasons: absence of target lesions, documented progression at trial entry, or ineligible histology.||participants|||Number
719543|NCT00298233|Secondary|Median Time (Days) on Ventilation|Use of mechanical ventilation at any time for subjects with severe influenza and avian influenza.|Throughout study, 14 days|||days||95% Confidence Interval|Median
719544|NCT00298233|Secondary|Median Time (Days) in ICU||Throughout study, 14 days|||days||95% Confidence Interval|Median
719545|NCT00298233|Secondary|Median Time (Days) Receipt of Oxygen||Throughout study, 14 days|||days||95% Confidence Interval|Median
719546|NCT00298233|Secondary|In-hospital Mortality Rates|Standard therapy with oseltamivir is five days. Those patients with persistent symptoms on day five were continued on the randomized dose for an additional five days and assessments were performed up to day 10.|After up to 10 days of treatment|||participants|||Number
719571|NCT00298363|Secondary|Median Change in MELD Score From Baseline at Week 144|MELD scores, used to assess prognosis and suitability for transplant, are calculated based on laboratory values only and can range from 6 to 40, with higher scores indicating greater disease severity.|Baseline to Week 144|Subjects in the full analysis set with an available score at the visit||units on a scale||Inter-Quartile Range|Median
719572|NCT00298363|Secondary|Median Change in MELD Score From Baseline at Week 96|MELD scores, used to assess prognosis and suitability for transplant, are calculated based on laboratory values only and can range from 6 to 40, with higher scores indicating greater disease severity.|Baseline to Week 96|Subjects in the full analysis set with an available score at the visit||units on a scale||Inter-Quartile Range|Median
719547|NCT00298233|Secondary|Participants Meeting Criteria for Day 5 Clinical Failure|"Proportion of participants that have clinical failure by day 5. Subjects that meet one of the following on Day 5 will be classified as a clinical failure:
Severe tachypnea (respiratory rate ≥ 30 for ages ≥12 years, rate ≥ 40 for ages 6 to 12 years, rate ≥45 for ages 3 to 6 years, rate ≥ 50 for ages 1 to 3 years)
Severe dyspnea (unable to speak full sentences, or use of accessory respiratory muscles)
Arterial oxygen saturation ≤92% on room air by trans-cutaneous method
Need for mechanical ventilation or intensive care unit (ICU) admission For the purpose of endpoint definition, death prior to or on Day 5 will also be considered a clinical failure at Day 5."|After 5 days of treatment|For the purpose of endpoint definition, death prior to or on Day 5 was also considered as clinical failure on day 5.In the double dose cohort, only 154 subjects completed fives days of drug and 7 died (total 161). In the standard dose cohort only 149 subjects completed 5 days of drug and 9 died (total 158).||participants|||Number
719548|NCT00298233|Primary|Proportion of All Participants Negative for Viral RNA on Day 5|Proportion of all participants with no detectable viral RNA by reverse transcriptase-polymerase chain reaction (RT-PCR) in a combined nasal and throat swab sample on day 5.|After 5 days of treatment|All randomized patients with RT-PCR proven influenza.||participants|||Number
719549|NCT00298272|Primary|Number of Participants With Clinically Significant Immunological and Laboratory Assessment Findings|The following immunological assessments were conducted: autoantibody concentrations for RF, anti-cyclic-citrullinated peptide (CCP) antibody concentrations, quantitative immunoglobulin levels, and lymphocyte assessments of T- and B-cell populations, determined using whole blood expanded fluorescent-activated cell sorter (FACS) analysis. The following laboratory assessments were performed: hemoglobin, hematocrit, red blood cells (RBC), white blood cells (WBC) with differential, and platelet counts; aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, total protein, albumin, total bilirubin, blood urea nitrogen (BUN), uric acid, creatinine, random glucose, potassium, sodium, chloride, calcium, and phosphorous; blood, protein, and glucose (microscopic examination, if abnormal and applicable).|Through Week 24|The Safety Population consisted of all participants who received any part of an infusion of rituximab or placebo.||participants|||Number
719550|NCT00298272|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Through Week 24|An AE was any sign (including an abnormal laboratory result that the investigator determined to be clinically significant), symptom, or diagnosis/disease that is unfavorable or unintended, that was new, or if pre-existing, worsened in a participant and that did not necessarily have a causal relationship with the treatment. An SAE was any event that resulted in death, resulted in a congenital anomaly in a child of a participant in the study, caused or prolonged an inpatient hospitalization, resulted in significant or persistent disability, or was considered by the investigator to be an important medical event that may have required intervention to prevent any of the above-listed outcomes.|Through Week 24|The Safety Population consisted of all participants who received any part of an infusion of rituximab or placebo.||participants|||Number
719551|NCT00298272|Primary|Maximum Duration of Infections Through Week 24|Infections were defined as adverse events that map to the Medical Dictionary for Regulatory Activities (MedDRA) system organ class (SOC) of “infections and infestations” and also included other infectious events that do not map to this SOC (e.g., cholecystitis, pleurisy, conjunctivitis, acne, tongue ulceration). For participants with multiple infections, only the infection with the longest duration was included in this analysis.|Week 24|Participants in the Safety Population with at least 1 infection. The Safety Population consisted of all participants who received any part of an infusion of rituximab or placebo.||days||Standard Deviation|Mean
719552|NCT00298272|Primary|Number of Participants With Any Infections or Any Grade 3/4 Infections Through Week 24|Infections were defined as adverse events that map to the Medical Dictionary for Regulatory Activities (MedDRA) system organ class (SOC) of “infections and infestations” and also included other infectious events that do not map to this SOC (e.g., cholecystitis, pleurisy, conjunctivitis, acne, tongue ulceration). Participants with multiple infections were calculated only once. The severity of all reported adverse events, including infections, was graded and reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events. This scale defines the severity of an adverse event as follows: Grade 1 = a mild adverse event, Grade 2 = a moderate adverse event, Grade 3 = a severe adverse event, and Grade 4 = a life-threatening or disabling adverse event.|Through Week 24|The Safety Population consisted of all participants who received any part of an infusion of rituximab or placebo.||participants|||Number
719553|NCT00298272|Secondary|Proportion of Participants Achieving an American College of Rheumatology 70 (ACR70) Response at Week 24|An ACR70 response is defined as a 70% reduction in the number of both swollen and tender joints, and a 70% reduction in the score or results of at least 3 of the following 5 core set measurement tools: Patient and physician assessment of patient disease activity (DA) in previous 24 hours on a visual analog scale (VAS, no DA to maximum DA); patient assessment of pain in previous 24 hours on a VAS (none to unbearable); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and C reactive protein or, if missing, erythrocyte sedimentation rate.|Week 24|The Safety Population consisted of all participants who received any part of an infusion of rituximab or placebo. Missing data were imputed using the nonresponder method, in which a participant with missing data at the visit being analyzed was considered a nonresponder.||proportion of participants|||Number
719554|NCT00298272|Secondary|Proportion of Participants Achieving an American College of Rheumatology 50 (ACR50) Response at Week 24|An ACR50 response is defined as a 50% reduction in the number of both swollen and tender joints, and a 50% reduction in the score or results of at least 3 of the following 5 core set measurement tools: Patient and physician assessment of patient disease activity (DA) in previous 24 hours on a visual analog scale (VAS, no DA to maximum DA); patient assessment of pain in previous 24 hours on a VAS (none to unbearable); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and C reactive protein or, if missing, erythrocyte sedimentation rate.|Week 24|The Safety Population consisted of all participants who received any part of an infusion of rituximab or placebo. Missing data were imputed using the nonresponder method, in which a participant with missing data at the visit being analyzed was considered a nonresponder.||proportion of participants|||Number
719711|NCT00299975|Secondary|Adverse Effects (e.g. Renal and Liver Function Tests)||pre-treatment & post-treatment||||||
719555|NCT00298272|Secondary|Proportion of Participants Achieving an American College of Rheumatology 20 (ACR20) Response at Week 24|An ACR20 response is defined as a 20% reduction in the number of both swollen and tender joints, and a 20% reduction in the score or results of at least 3 of the following 5 core set measurement tools: Patient and physician assessment of patient disease activity (DA) in previous 24 hours on a visual analog scale (VAS, no DA to maximum DA); patient assessment of pain in previous 24 hours on a VAS (none to unbearable); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and C reactive protein or, if missing, erythrocyte sedimentation rate.|Week 24|The Safety Population consisted of all participants who received any part of an infusion of rituximab or placebo. Missing data were imputed using the nonresponder method, in which a participant with missing data at the visit being analyzed was considered a nonresponder.||proportion of participants|||Number
719556|NCT00298272|Primary|Proportion of Participants With at Least One Serious Infection Through Week 24|An infection was considered serious if it required intravenous (IV) antibiotics or met the regulatory definition of a serious adverse event (SAE). An SAE was any event that resulted in death, resulted in a congenital anomaly in a child of a participant in the study, caused or prolonged an inpatient hospitalization, resulted in significant or persistent disability, or was considered by the investigator to be an important medical event that may have required intervention to prevent any of the above-listed outcomes.|Through Week 24|The Safety Population consisted of all participants who received any part of an infusion of rituximab or placebo.||proportion of participants|||Number
719557|NCT00298363|Secondary|In the Subset of Participants Undergoing Liver Transplantation, Time to Recurrence of Hepatitis B, Defined as 2 Consecutive Plasma HBV DNA Concentrations ≥ 400 Copies/mL or 2 Consecutive HBsAg(+) Results||Baseline to Week 168|Liver transplantation analysis set||Days|||Number
719558|NCT00298363|Secondary|Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 168|Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. HBsAg seroconversion was defined as change of detectable antibody to HBsAg from negative to positive.|Baseline to Week 168|Full analysis set; noncompleters/switch = failure||percentage of participants|||Number
719559|NCT00298363|Secondary|Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 144|Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. HBsAg seroconversion was defined as change of detectable antibody to HBsAg from negative to positive.|Baseline to Week 144|Full analysis set; noncompleters/switch = failure||percentage of participants|||Number
719560|NCT00298363|Secondary|Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 96|Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. HBsAg seroconversion was defined as change of detectable antibody to HBsAg from negative to positive.|Baseline to Week 96|Full analysis set; noncompleters/switch = failure||percentage of participants|||Number
719561|NCT00298363|Primary|Percent Probability of a Confirmed Increase in Serum Creatinine of ≥ 0.5 mg/dL From Baseline or a Confirmed Serum Phosphorus Level < 2.0 mg/dL|Results are expressed as proportions of participants who experience a confirmed increase in serum creatinine of ≥ 0.5 mg/dL from baseline or a confirmed serum phosphorus level < 2.0 mg/dL using the KM method of estimation.|Baseline to Week 168|Full analysis set||percent probability (KM estimate)||95% Confidence Interval|Number
719562|NCT00298363|Other Pre-specified|Percentage of Participants With Baseline ADV-R + LAM-R Mutations Achieving HBV DNA < 400 Copies/mL by 168 Weeks|ADV resistance mutation + LAM resistance mutations are defined as the presence of the rtA181T/V HBV gene mutation and/or the rtN236T HBV gene mutation, and the rtM204V/I HBV gene mutation with or without the rtL180M HBV gene mutation.|Baseline to Week 168|Participants in the full analysis set with both ADV and LAM resistance mutations at baseline were included in this analysis.||percentage of participants|||Number
719563|NCT00298363|Other Pre-specified|Percentage of Participants With Only Baseline Lamivudine-resistance (LAM-R) Mutations Achieving HBV DNA < 400 Copies/mL by 168 Weeks|LAM resistance mutations are defined as the presence of the rtM204V/I HBV gene mutation with or without the rtL180M HBV gene mutation.|Baseline to Week 168|Patients in the full analysis set with LAM resistance mutation at baseline were included in this analysis.||percentage of participants|||Number
719564|NCT00298363|Other Pre-specified|Percentage of Participants With Only Baseline Adefovir Dipivoxil Resistance (ADV-R) Mutations Achieving HBV DNA < 400 Copies/mL by 168 Weeks|ADV resistance mutations are defined as the presence of the rtA181T/V HBV gene mutation and/or the rtN236T HBV gene mutation.|Baseline to Week 168|Participants in the full analysis set with ADV resistance mutation at baseline were included in this analysis.||percentage of participants|||Number
719565|NCT00298363|Secondary|Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss and HBsAg Seroconversion at Week 48|Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. HBsAg seroconversion was defined as change of detectable antibody to HBsAg from negative to positive.|Baseline to Week 48|Full analysis set; noncompleters/switch = failure||percentage of participants|||Number
719566|NCT00298363|Secondary|Percentage of Participants With HBeAg Loss and HBeAg Seroconversion at Week 168 (for Participants Who Were HBeAg Positive at Baseline)|Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive.|Baseline to Week 168|Serologically evaluable analysis set; noncompleters/switch = failure||percentage of participants|||Number
719567|NCT00298363|Secondary|Percentage of Participants With HBeAg Loss and HBeAg Seroconversion at Week 144 (for Participants Who Were HBeAg Positive at Baseline)|Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive.|Baseline to Week 144|Serologically evaluable analysis set; noncompleters/switch = failure||percentage of participants|||Number
719568|NCT00298363|Secondary|Percentage of Participants With HBeAg Loss and HBeAg Seroconversion at Week 96 (for Participants Who Were HBeAg Positive at Baseline)|Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive.|Baseline to Week 96|Serologically evaluable analysis set; noncompleters/switch = failure||percentage of participants|||Number
720116|NCT00300742|Primary|Mean Drinks Per Day at Baseline vs. Visit 12|Mean drinks per day at baseline vs. Visit 12 measured by self report on timeline follow-back (TLFB) calendars in conjunction with the subject's daily diary|up to 24 weeks|Per protocol||Drinks/day||Standard Deviation|Mean
719574|NCT00298363|Secondary|Percentage of Participants With a Decrease in CPT Score of ≥ 2 Points From Baseline at Week 168|CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease.|Baseline to Week 168|CPT evaluable analysis set; noncompleters/switch = failure||percentage of participants|||Number
719575|NCT00298363|Secondary|Percentage of Participants With a Decrease in CPT Score of ≥ 2 Points From Baseline at Week 144|CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease.|Baseline to Week 144|CPT evaluable analysis set; noncompleters/switch = failure||percentage of participants|||Number
719576|NCT00298363|Secondary|Percentage of Participants With a Decrease in CPT Score of ≥ 2 Points From Baseline at Week 96|CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease.|Baseline to Week 96|CPT evaluable analysis set; noncompleters/switch = failure||percentage of participants|||Number
719577|NCT00298363|Secondary|Percentage of Participants With a Decrease in CPT Score of ≥ 2 Points From Baseline at Week 48|CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease.|Baseline to Week 48|CPT evaluable analysis set (subjects with CPT scores ≥ 7 at baseline; because the minimum CPT score was 5, only these subjects were evaluable for analyses of ≥ 2-point decrease in CPT score); noncompleters/switch = failure||percentage of participants|||Number
719578|NCT00298363|Secondary|Percentage of Participants With an Increase in CPT Score of ≥ 2 Points at Week 168|CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease.|Baseline to Week 168|Full analysis set; noncompleters/switch = failure||percentage of participants|||Number
719579|NCT00298363|Secondary|Percentage of Participants With an Increase in CPT Score of ≥ 2 Points at Week 144|CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease.|Baseline to Week 144|Full analysis set; noncompleters/switch = failure||percentage of participants|||Number
719580|NCT00298363|Secondary|Percentage of Participants With an Increase in CPT Score of ≥ 2 Points at Week 96|CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease.|Baseline to Week 96|Full analysis set; noncompleters/switch = failure||percentage of participants|||Number
719581|NCT00298363|Secondary|Percentage of Participants With an Increase in Child-Pugh Turcotte (CPT) Score of ≥ 2 Points at Weeks 48|CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease.|Baseline to Week 48|Full analysis set; noncompleters/switch = failure||percentage of participants|||Number
719582|NCT00298363|Secondary|Percentage of Participants With Normalized ALT (for Subjects With Elevated ALT at Baseline) at Week 168|Normalized ALT is defined as having a baseline ALT value > ULN, and a decrease in ALT value to ≤ ULN at the given time point.|Baseline to Week 168|Biochemically evaluable analysis set; noncompleters/switch = failure||percentage of participants|||Number
719583|NCT00298363|Secondary|Percentage of Participants With Normalized ALT (for Subjects With Elevated ALT at Baseline) at Week 144|Normalized ALT is defined as having a baseline ALT value > ULN, and a decrease in ALT value to ≤ ULN at the given time point.|Baseline to Week 144|Biochemically evaluable analysis set; noncompleters/switch = failure||percentage of participants|||Number
719584|NCT00298363|Secondary|Percentage of Participants With Normalized ALT (for Subjects With Elevated ALT at Baseline) at Week 96|Normalized ALT is defined as having a baseline ALT value > ULN, and a decrease in ALT value to ≤ ULN at the given time point.|Baseline to Week 96|Biochemically evaluable analysis set; noncompleters/switch = failure||percentage of participants|||Number
719585|NCT00298363|Secondary|Percentage of Participants With Normalized Alanine Aminotransferase (ALT) (for Subjects With Elevated ALT at Baseline) at Week 48|Normalized ALT is defined as having a baseline ALT value > the upper limit of the normal range (ULN), and a decrease in ALT value to ≤ ULN at the given time point.|Baseline to Week 48|Biochemically evaluable analysis set (subjects in full analysis set with abnormal baseline alanine aminotransferase [ALT] values); noncompleters/switch = failure||percentage of participants|||Number
719586|NCT00298363|Secondary|Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 168|The percentage of participants with plasma HBV DNA < 400 copies/mL at Week 168 was summarized.|Week 168|Full analysis set; noncompleters/switch = failure||percentage of participants|||Number
719587|NCT00298363|Secondary|Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 144|The percentage of participants with plasma HBV DNA < 400 copies/mL at Week 144 was summarized.|Week 144|Full analysis set; noncompleters/switch = failure||percentage of participants|||Number
719588|NCT00298363|Secondary|Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 96|The percentage of participants with plasma HBV DNA < 400 copies/mL at Week 96 was summarized.|Week 96|Full analysis set; noncompleters/switch = failure||percentage of participants|||Number
719589|NCT00298363|Secondary|Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 48|The percentage of participants with plasma HBV DNA < 400 copies/mL at Week 48 was summarized.|Week 48|Full analysis set; noncompleters/switch = failure analysis (participants who did not complete treatment or changed from double-blind to open-label treatment up to the time point were considered as failing to meet efficacy response criteria [defined as not achieving viral suppression of < 400 copies/mL]).||percentage of participants|||Number
719590|NCT00298363|Secondary|Median DAVG in Plasma HBV DNA Levels at 168 Weeks Relative to Baseline|Change from baseline was evaluated by subtracting baseline HBV DNA log_10 copies/mL from Week 168 HBV DNA log_10 copies/mL. DAVG is defined as the area of the trapezoid under the response-time curve divided by time to the last available evaluation of the patient minus the baseline value.|Baseline to 168 weeks|Full analysis set; data collected for participants who underwent liver transplant prior to Week 168 were excluded.||log_10 copies/mL||Inter-Quartile Range|Median
719591|NCT00298363|Secondary|Median DAVG in Plasma HBV DNA Levels at 144 Weeks Relative to Baseline|Change from baseline was evaluated by subtracting baseline HBV DNA log_10 copies/mL from Week 144 HBV DNA log_10 copies/mL. DAVG is defined as the area of the trapezoid under the response-time curve divided by time to the last available evaluation of the patient minus the baseline value.|Baseline to 144 weeks|Full analysis set; data collected for participants who underwent liver transplant prior to Week 144 were excluded.||log _10 copies/mL||Inter-Quartile Range|Median
719592|NCT00298363|Secondary|Median DAVG in Plasma HBV DNA Levels at 96 Weeks Relative to Baseline|Change from baseline was evaluated by subtracting baseline HBV DNA log_10 copies/mL from Week 96 HBV DNA log_10 copies/mL. DAVG is defined as the area of the trapezoid under the response-time curve divided by time to the last available evaluation of the patient minus the baseline value.|Baseline to 96 weeks|Full analysis set; data collected for participants who underwent liver transplant prior to Week 96 were excluded.||log_10 copies/mL||Inter-Quartile Range|Median
719593|NCT00298363|Secondary|Median Time-averaged Change (DAVG) in Plasma Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels at 48 Weeks Relative to Baseline|Change from baseline was evaluated by subtracting baseline HBV DNA log_10 copies/mL from Week 48 HBV DNA log_10 copies/mL. DAVG is defined as the area of the trapezoid under the response-time curve divided by time to the last available evaluation of the patient minus the baseline value.|Baseline to 48 weeks|Participants with HBV DNA measurements at Week 48 were included in this analysis.||log_10 copies/mL||Inter-Quartile Range|Median
719594|NCT00298363|Primary|Percent Probability of Tolerability Failure|Tolerability failure was defined as permanent discontinuation of study drug due to a treatment-emergent adverse event (AE), including any subject who temporarily discontinued study drug due to an AE and did not restart. Results are expressed as proportions of participants who experience tolerability failure using the Kaplan-Meier (KM) method of estimation.|Baseline to Week 168|Full analysis set (all randomized subjects who received at least one dose of study drug)||percent probability (KM estimate)||95% Confidence Interval|Number
719595|NCT00298558|Primary|Changes in Everyday Speed of Processing From Baseline to Year 10|"Everyday Speed of processing was computed as the summation of Complex Reaction Time (CRT) and Timed IADL (TIADL). For the analysis, the reversed score was used and the possible range of the reversed everyday speed of processing outcome is -3 to 100. Higher values for the reversed scores represent a better outcome. Changes in outcome were computed as 10 year minus baseline and the negative values indicate the decline from baseline."|Up to 10 years|Of the randomized subjects, 938 subjects who had the everyday speed of processing outcome at year 10 were used.||units on a scale||Standard Deviation|Mean
719596|NCT00298558|Primary|Changes in Everyday Problem Solving From Baseline to Year 10|"Everyday Problem Solving was computed as the summation of the Everyday Problems Test (EPT) and Observed Tasks of Daily Living (OTDL). The possible range of the everyday problem solving outcome is 0 to 56. Higher values represent a better outcome. Changes in outcome were computed as 10 year minus baseline and the negative values indicate the decline from baseline."|Up to 10 years|Of the randomized subjects, 1104 subjects who had the everyday problem solving outcome at year 10 were used.||units on a scale||Standard Deviation|Mean
719597|NCT00298558|Primary|Changes in Instrumental Activities of Daily Living (IADL) Difficulty From Baseline to Year 10|"The self-reported measure of everyday IADL function was the summation of the IADL difficulty sub-scores from the Minimum Dataset - Home Care (MDS-HC) which assesses performance in the past 7 days on 19 daily tasks spanning meal preparation, housework, finances, health care, telephone, shopping, travel, and need for assistance in dressing, personal hygiene, and bathing. For the analysis, the reversed score was used and the possible range of the reversed everyday IADL function outcome is 0 to 38. Higher values for the reversed scores represent a better outcome. Changes in outcome were computed as 10 year minus baseline and the negative values indicate the decline from baseline."|Up to 10 years|Of the randomized subjects, 1211 subjects who had the IADL outcome at year 10 were used.||units on a scale||Standard Deviation|Mean
719598|NCT00298558|Primary|Changes in Cognitive Abilities of Speed of Processing From Baseline to Year 10|"Speed of processing outcome was computed as the summation of three Useful Field of View tasks requiring identification and localization of information, with 75% accuracy, under varying levels of cognitive demand. For the analysis, the reversed score was used and the possible range of the reversed speed of processing outcome is 0 to 1500. Higher values for the reversed scores represent a better outcome. Changes in outcome were computed as 10 year minus baseline and the negative values indicate the decline from baseline."|Up to 10 years|Of the randomized subjects, 879 subjects who had the speed outcome at year 10 were used.||units on a scale||Standard Deviation|Mean
719599|NCT00298558|Secondary|Estimate the Effects of ACTIVE Training to General Population|To estimate and project the effects of ACTIVE training to the general population of older adults by linking the measures and outcomes of ACTIVE to the Health and Retirement Study(and its subsidiary studies), a population-based, nationally-representative cohort.|10th Year||||||
719600|NCT00298558|Primary|Changes in Cognitive Abilities of Reasoning From Baseline to Year 10|"Reasoning outcome was computed as the summation of total correct for Letter Series, Letter Sets, and Word Series. The possible range of the reasoning outcome is 0 to 75. Higher values represent a better outcome. Changes in outcome were computed as 10 year minus baseline and the negative values indicate the decline from baseline."|Up to 10 years|Of the randomized subjects, 938 subjects who had the reasoning outcome at year 10 were used.||units on a scale||Standard Deviation|Mean
719601|NCT00298558|Secondary|Examine Health, Genetic and Cognitive Moderators|To examine heath, genetic, and cognitive moderators (including cardiovascular disease,diabetes, depression, Apolipoprotein E (APOE) genotype, and low cognition and engagement) in individual response to training.|10th Year||||||
719602|NCT00298558|Secondary|Changes in Health-related Quality of Life (HRQol), Driving Function, Health Service Use|To determine if the cognitive interventions have beneficial effects on the distal outcomes of driving safety, personal care activities of daily living, health service utilization, and mortality.|10th Year||||||
719603|NCT00298558|Primary|Changes in Cognitive Abilities of Memory From Baseline to Year 10|"Memory outcome was computed as the summation of Rey Auditory-Verbal Learning Test (AVLT), the Hopkins Verbal Learning Test (HVLT), and the Rivermead Behavioral Paragraph Recall test immediate recall. The possible range of the memory outcome is 0 to 132. Higher values represent a better outcome. Changes in outcome were computed as 10 year minus baseline and the negative values indicate the decline from baseline."|Up to 10 years|Of the randomized subjects, 943 subjects who had the memory outcome at year 10 were used.||units on a scale||Standard Deviation|Mean
719604|NCT00298610|Secondary|Safety - Serious Adverse Event (SAE) Relationship to Study Drug|Determine the safety (defined as relationship to study drug of SAE's)|Up to 14 days|||Number of events|||Number
719605|NCT00298610|Secondary|Safety - Severity of Serious Adverse Events (SAE's)|Determine the safety (defined as severity of SAE's using the Common Toxicity Criteria)|up to 14 days|||Number of events|||Number
719606|NCT00298610|Secondary|Safety - Adverse Events Relationship to Study Drug|Determine the safety (defined as relationship to study drug of AE's and SAE's)|up to 14 days|||Number of adverse events|||Number
719607|NCT00298610|Secondary|Safety - Severity of Adverse Events|Determine the safety (defined as severity of AE's using the Common Toxicity Criteria)|up to 14 days|||Number of adverse events|||Number
719608|NCT00298610|Secondary|Number of Subjects With Fever Clearance|Temperature is measured by oral digital thermometers, and fever clearance time is defined as the first time with resolution of fever (<37.5C) sustained for 24 hours|Within 48 hours post dose|Summary of subject with fever clearance, defined as first sustained absence of fever (<37.5C for least 24 hours)||Participants|||Count of Participants
719609|NCT00298610|Secondary|Percentage of Parasite Clearance|The target variable is detection (percentage) of asexual stage parasites of Plasmodium falciparum malaria in bloodstream by Giemsa - stained microscopy of thick and thin blood smears|24 and 48 hours post dose|Percentage of parasite clearance within the first 24 and 48 hours post dose of intravenous artesunate||percentage of parasite clearance||Standard Deviation|Mean
719610|NCT00298610|Primary|Change in Percentage of Parasites Detected at 48 Hours|Change in Percentage of Parasites Detected at 48 Hours. With positive numbers to represent increases and negative numbers to represent decreases|48 hours|Percentage of parasite change at 48 hours post dose||percentage of parasite change||Standard Deviation|Mean
719611|NCT00298740|Primary|Glucose Control as Assessed by Mean Glucose Levels||End of study, approximately 5 years|It is unclear whether data was collected. No data is available and exhaustive searching has yielded no person with historical knowledge of this study or access to any data. Information obtained in other sections was from Regulatory records retrieved from long-term storage. This study closed in 2009 and the Principal Investigator is deceased.|||||
719612|NCT00298766|Primary|Subjects With Treatment Emergent Adverse Events Leading to Treatment Termination|Treatment emergent adverse events observed during outcome measure time frame leading to treatment termination|from first study-related procedure to 30 days after last dose of study medication|Safety population||participants|||Number
719613|NCT00298766|Primary|Subjects Grade 3/4/5 Treatment Emergent Adverse Events|"Grade 3/4/5 treatment emergent adverse events observed during outcome measure time frame.
Grade is determined according to Common Terminology Criteria for Adverse Event (CTCAE) Version 3.0."|from first study-related procedure to 30 days after last dose of study medication|Safety population||participants|||Number
719614|NCT00298766|Primary|Subjects With Serious Treatment Emergent Adverse Events|Serious treatment emergent adverse events observed during outcome measure time frame|from first study-related procedure to 30 days after last dose of study medication|Safety population||participants|||Number
719615|NCT00298766|Secondary|Best Confirmed Hematologic Responders|Hematologic response was determined by the investigator per the response criteria for immunoglobulin light chain amyloidosis by Gertz (2005). It include Complete and Partial Responders (CR+PR). CR requires serum and urine negative for a monoclonal protein by immunofixation and free light chain ratio normal. PR requires: 1. reduction in quantitative serum M-protein by 50% if baseline value is at least 0.5 g/dL, 2. if light chain is detected in the urine (with a consistent peak and >100 mg/ 24 hours), then 50% reduction is required, 3. if free light chain >10 mg/dL, reduction by 50% is required.|from first dose of study medication to end of study visit|Efficacy population included all treated subjects with an evaluable post baseline resposne assessment in the MTD cohorts (1.6 mg/m^2 QW and 1.3 mg/m^2 BIW).||participants responded|||Number
719616|NCT00298766|Primary|Subjects With Treatment Emergent Adverse Events|Treatment emergent adverse events observed during outcome measure time frame|from first study-related procedure to 30 days after last dose of study medication|Safety population||participants|||Number
719617|NCT00298766|Primary|Maximum Tolerated Dose|"Maximum Tolerated Dose (MTD) was defined as the highest dose level that has 0/1 out of 6 patients experiences Dose Limited Toxicity (DLT). MTD is defined separately for QW and BIQ dose cohorts.
DLT was defined as adverse events occurring during Cycle 1 and: (1) related to VELCADE, (2) Grade 4 thrombocytopenia or neutropenia, (3) Grade 3 or higher nonhematologic toxicity."|5 weeks in once weekly (QW) dose cohorts and 3 weeks in twice weekly (BIW) dose cohorts|Phase 1 Safety Population includes all subjects who received at least one dose of VELCADE in phase 1 dose escalation cohorts||participants with DLT|||Number
719618|NCT00299000|Primary|Change in Haed Circumference||52 weeks|||centimeter||Standard Deviation|Mean
719619|NCT00299000|Primary|Change in Weight||52 weeks|||kilograms||Standard Deviation|Mean
719620|NCT00299000|Primary|Change in Height||52 weeks|Intention to treat.||centimeters||Standard Deviation|Mean
719621|NCT00299000|Secondary|Change in Urinary Glycosaminoglycan Levels|Change in urinary GAG levels was calculated from baseline to week 52 of treatment.|minimum 52 weeks of dosing|Intention to treat.||ug/mg creatinine||Standard Deviation|Mean
719638|NCT00299104|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Good Response at Week 52|European League Against Rheumatism (EULAR) criteria reflects an improvement in disease activity and an attainment of a lower degree of disease activity. A good response is defined as an improvement in the DAS28-ESR of > 1.2 compared with baseline, and attainment of a DAS28-ESR of < 3.2.|Baseline, Week 52|Intent to treat (ITT) population includes all randomized participants who received at least one infusion. Patients are considered non-responders if data are missing||Percentage of Participants|||Number
720117|NCT00300742|Primary|Compliance With Study Requirements: Attendance at Treatment Sessions||up to 12 weeks|||participants|||Number
719622|NCT00299104|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 104|The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0(without any difficulty) to 4 (unable to do). HAQ-DI=sum of worst scores in each domain divided by the number of domains answered. A negative change from baseline indicates improvement.|Baseline, Week 104|Participants from the Intent-to treat Population includes all randomized participants who received at least one dose of study drug with data at baseline and Week 104 available for analysis. Last observation carried forward.||Score on a scale||Standard Deviation|Mean
719623|NCT00299104|Secondary|Percentage of Participants Without Radiographic Progression in the Total Erosion Score at Week 104|"Total Erosion Score is determined by evaluation of fourteen sites in each wrist and hand and six joints in each foot using an eight-point scale from 0 (normal: no erosions) to 3.5 (Very severe; erosions of 100% of the articular surfaces. The score at baseline is compared to the score at week 104.
No progression is defined as a change from score at screening to week 104 ≤0."|Week 104|Participants from the Modified Intent to Treat (MITT) population includes all randomized participants who received at least one infusion and had both screening and post-baseline radiographic assessments. Patients with missing data are classified as progressing.||Percentage of Participants|||Number
719624|NCT00299104|Secondary|Percentage of Participants Without Radiographic Progression at Week 104|Percentage of patients without radiographic progression at Week 104, defined as change in total modified Sharp score (TMSS) ≤ 0. TMSS is the sum of the erosion score (ES) and the joint space narrowing (JSN) score and has a range of 0 to 398. The ES is the sum of joint scores collected for 46 joints and has a range of 0 to 230. The JSN is the sum of joint scores collected for 42 joints and has a range of 0 to 168. A score of 0 would indicate no change.|Baseline, Week 104|Modified Intent to Treat (MITT) population includes all randomized participants who received at least one infusion and had both screening and post-baseline radiographic assessments. Patients with missing data are classified as progressing||Percentage of Participants|||Number
719625|NCT00299104|Secondary|Change From Baseline in the Total Erosion Score at Week 104|Total Erosion Score is determined by evaluation of fourteen sites in each wrist and hand and six joints in each foot using an eight-point scale from 0 (normal: no erosions) to 3.5 (Very severe; erosions of 100% of the articular surfaces. The change from the score at baseline to week 104 is calculated.|Baseline, Week 104|Participants from the Modified Intent to Treat (MITT) population includes all randomized participants who received at least one infusion and who had both screening and post-baseline radiographic assessments at the given time point for analyses. Linear extrapolation used for missing data.||Score on a scale||Standard Deviation|Mean
719626|NCT00299104|Secondary|Change From Baseline in the Modified Total Sharp Score at Week 104|The modified total sharp score is the sum of the erosion score (ES) and the joint space narrowing (JSN) score and has a range of 0 to 398. The ES is the sum of joint scores collected for 46 joints and has a range of 0 to 230. The JSN is the sum of joint scores collected for 42 joints and has a range of 0 to 168. A score of 0 would indicate no change and higher scores represent a worsening of joint erosions and joint space narrowing.|Baseline, Week 104|Participants from the Modified Intent to Treat (MITT) population includes all randomized participants who received at least one infusion and had both screening and post-baseline radiographic assessments at the given time-point for analysis. Linear extrapolation was used for missing data.||Score on a scale||Standard Deviation|Mean
719627|NCT00299104|Secondary|Percentage of Patients With Minimally Clinically Important Difference (MCID) in the SF-36 Mental Health Component Score at Week 52|"MCID is defined as a change from baseline in SF-36 Mental Health Component Score of >6.33.
SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from baseline indicates improvement."|Baseline, Week 52|Participants from the Intent-to-treat population, includes all randomized participants who received at least one dose of study drug, with data available for analysis at Baseline and Week 52. Last observation carried forward.||Percentage of Participants|||Number
719628|NCT00299104|Secondary|Percentage of Patients With Minimally Clinically Important Difference (MCID) in the SF-36 Physical Health Component Score at Week 52|"MCID is defined as a change from baseline in SF-36 Physical Health Component Score of >5.42.
SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from baseline indicates improvement."|Baseline, Week 52|Participants from the Intent-to-treat population, includes all randomized participants who received at least one dose of study drug, with data available for analysis at Baseline and Week 52. Last observation carried forward.||Percentage of Participants|||Number
719629|NCT00299104|Secondary|Percentage of Participants With Categorical Change in Health Assessment Questionnaire- Disability Index (HAQ-DI) From Baseline at Week 52|"The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Each domain has at least two component questions. There are four possible responses for each component on a scale of 0 (without difficulty) to 3 (unable to do). Higher scores=greater dysfunction.
Improved:HAQ-DI score change <=-0.22 Unchanged:HAQ-DI score change -0.22 to 0.22 Worsened:HAQ score => 0.22"|Baseline, Week 52|Intent to treat (ITT) population includes all randomized participants who received at least one infusion. Last observation carried forward.||Percentage of participants|||Number
719692|NCT00299416|Secondary|Efficacy: NIHSS < 2 at 24 Hours, Modified Rankin Scale (mRS) < 2 at 3 Months, NIHSS < 2 at 3 Months, and Length of Hospital and ICU Stay.|NIHSS score of ≤ 2 24 hours after stroke onset modified Rankin Scale (mRS) < 2 at 90 day followup NIHSS score of ≤ 2 at daily duration of hospitalization and ICU stay and 90 day follow up.|90 days||||||
719630|NCT00299104|Secondary|Change From Baseline in the SF-36 Mental Health Component Summary Score at Week 52 and Week 104|"The SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from baseline indicates improvement.
Means are adjusted for baseline value, Rheumatoid Factor status and region."|Baseline, Weeks 52, Week 104|"Intent to treat (ITT) population includes all randomized participants who received at least one infusion. Last observation carried forward. n in each of the categories is the number of participants with data available for analyses at the given time point."||Score on a scale||Standard Deviation|Mean
719631|NCT00299104|Secondary|Change From Baseline in the SF-36 Physical Health Component Summary Score at Week 52 and Week 104|"The SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from baseline indicates improvement.
Means are adjusted for baseline value, Rheumatoid Factor status and region."|Baseline, Week 52, Week 104|"Intent to treat (ITT) population includes all participants who received at least one infusion. Last observation carried forward. n in each of the categories is the number of participants with data available for analyses at the given time point."||Score on a scale||Standard Deviation|Mean
719632|NCT00299104|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 52|The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip,and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0(without any difficulty) to 4 (unable to do).HAQ-DI=sum of worst scores in each domain divided by the number of domains answered. A negative change from baseline indicates improvement.|Baseline, Week 52|Intent-to treat Population includes all randomized participants who received at least one dose of study drug. Last observation carried forward.||Score on a scale||Standard Deviation|Mean
719633|NCT00299104|Secondary|Change in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Score From Baseline at Week 52|FACIT-F is a 13-item questionnaire. Patients scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the patient's response to the questions (with the exception of 2 negatively stated), the greater the patient's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the patient's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the patient's health status.|Baseline, Week 52|Participants from the Intent to treat (ITT) population includes all randomized participants who received at least one infusion who had data available for analyses. Observed data.||Score on a scale||Standard Deviation|Mean
719634|NCT00299104|Secondary|Percentage of Participants With American College of Rheumatology (ACR) ACR90 Response at Week 52|"To achieve an ACR90 response requires at least a 90% improvement compared with baseline in both Total Joint Count and Swollen Joint Count, as well as a 90% improvement in three of five additional measurements from:
the physician's global assessment of disease activity
patient's global assessment of disease activity
patient's assessment of pain
HAQ-DI (Health Assessment Questionnaire disability index)
an acute phase reactant C-Reactive Protein (CRP). (If CRP was missing then Erythrocyte Sedimentation Rate (ESR) was used if available.)"|Baseline, Week 52|Intent to treat (ITT) population includes all randomized participants who received at least one infusion. Patients are considered non-responders if data are missing or from the point of withdrawal, rescue use or receipt of non-permitted Disease-modifying anti-rheumatic drugs (DMARDs).||Percentage of Participants|||Number
719635|NCT00299104|Secondary|Percentage of Participants With American College of Rheumatology (ACR) ACR20 Response at Week 52|"To achieve an ACR20 response requires at least a 20% improvement compared with baseline in both Total Joint Count and Swollen Joint Count, as well as a 20% improvement in three of five additional measurements from:
the physician's global assessment of disease activity
patient's global assessment of disease activity
patient's assessment of pain
HAQ-DI (Health Assessment Questionnaire disability index)
an acute phase reactant C-Reactive Protein (CRP). (If CRP was missing then Erythrocyte Sedimentation Rate (ESR) was used if available.)"|Baseline, Week 52|Intent to treat (ITT) population includes all randomized participants who received at least one infusion. Patients are considered non-responders if data are missing or from the point of withdrawal, rescue use or receipt of non-permitted Disease-modifying anti-rheumatic drugs (DMARDs).||Percentage of Participants|||Number
719636|NCT00299104|Secondary|Percentage of Participants With DAS28-ESR Low Disease Activity at Week 52|"The DAS28-4(ESR) score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity (mm), and ESR. DAS28-4(ESR) scores range from 0 - 10.
Low disease activity is defined as achieving a DAS28-ESR score of less than or equal to 3.2"|Week 52|Participants from the Intent to treat (ITT) population includes all randomized participants who received at least one infusion who had data available for analyses.||Percentage of Participants|||Number
719637|NCT00299104|Secondary|The Percentage of Participants With Major Clinical Response at Week 52|"Major clinical response is defined as a continuous six-month period of success by the ACR70.
ACR70= 70% improvement compared with baseline in both Total Joint Count and Swollen Joint Count, as well as a 70% improvement in 3 of five additional measurements from:
the physician’s global assessment of disease activity
patient’s global assessment of disease activity
patient’s assessment of pain
HAQ-DI (Health Assessment Questionnaire disability index)
an acute phase reactant C-Reactive Protein (CRP). (If CRP was missing then Erythrocyte Sedimentation Rate (ESR) was used if available.)"|Week 52|Intent to treat (ITT) population includes all randomized participants who received at least one infusion.||Percentage of Participants|||Number
719693|NCT00299416|Secondary|Achievement of Therapeutic Serum Ethanol and Caffeine Levels, and Amount of Sedation Needed to Suppress Shivering.||rewarming over 12 hours until 36.5C has been achieved||||||
719639|NCT00299104|Secondary|Percentage of Participants With DAS28-ESR Remission at Week 52|"The DAS28-4(ESR) score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity (mm), and ESR. DAS28-4(ESR) scores range from 0 - 10.
Remission is defined as achieving a DAS28-ESR score of less than 2.6"|Week 52|Participants from the Intent to treat (ITT) population includes all randomized participants who received at least one infusion with data available for analyses.||Percentage of Participants|||Number
719640|NCT00299104|Secondary|Percentage of Participants With American College of Rheumatology (ACR) ACR70 Response at Week 52|"To achieve an ACR70 response requires at least a 70% improvement compared with baseline in both Total Joint Count and Swollen Joint Count, as well as a 70% improvement in three of five additional measurements from:
the physician's global assessment of disease activity
patient's global assessment of disease activity
patient's assessment of pain
HAQ-DI (Health Assessment Questionnaire disability index)
an acute phase reactant C-Reactive Protein (CRP). (If CRP was missing then Erythrocyte Sedimentation Rate (ESR) was used if available.)"|Baseline, Week 52|Intent to treat (ITT) population includes all randomized participants who received at least one infusion. Patients are considered non-responders if data are missing or from the point of withdrawal, rescue use or receipt of non-permitted Disease-modifying anti-rheumatic drugs (DMARDs).||Percentage of Participants|||Number
719641|NCT00299104|Secondary|Change From Baseline in the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS28-ESR) at Week 52|"DAS28-ESR is calculated from the following formula:
(0.56 * TJC) + (0.28 * SJC) + (0.70 * ln ESR) + (0.014 * GH) TJC = tender joint count, based on 28 joints SJC = swollen joint count, based on 28 joints ESR = erythrocyte sedimentation rate in mm/h GH = patient’s global assessment of disease activity A DAS28-ESR score of 5.1 or above is considered to indicate high disease activity. Patients can also be defined as having low disease activity (DAS28-ESR ≤ 3.2) or remission (DAS28-ESR < 2.6)."|Baseline, Week 52|Participants from the Intent to treat (ITT) population includes all randomized participants who received at least one infusion who had data available for analyses. Last observation carried forward.||Score on a scale||Standard Deviation|Mean
719642|NCT00299104|Secondary|Percentage of Participants With American College of Rheumatology (ACR) ACR50 Response at Week 52|"To achieve an ACR50 response requires at least a 50% improvement compared with baseline in both Total Joint Count and Swollen Joint Count, as well as a 50% improvement in three of five additional measurements from:
the physician’s global assessment of disease activity
patient’s global assessment of disease activity
patient’s assessment of pain
HAQ-DI (Health Assessment Questionnaire disability index)
an acute phase reactant C-Reactive Protein (CRP). (If CRP was missing then Erythrocyte Sedimentation Rate (ESR) was used if available.)"|Week 52|Intent to treat (ITT) population includes all randomized participants who received at least one infusion. Patients are considered non-responders if data are missing or from the point of withdrawal, rescue use or receipt of non-permitted Disease-modifying anti-rheumatic drugs (DMARDs).||Percentage of Participants|||Number
719643|NCT00299104|Secondary|Percentage of Participants Without Radiographic Progression at Week 24|Percentage of patients without radiographic progression at Week 24 defined as change in total modified Sharp score (TMSS) ≤ 0. TMSS is the sum of the erosion score (ES) and the joint space narrowing (JSN) score and has a range of 0 to 398. The ES is the sum of joint scores collected for 46 joints and has a range of 0 to 230. The JSN is the sum of joint scores collected for 42 joints and has a range of 0 to 168. A score of 0 would indicate no change.|Baseline, Week 24|Modified Intent to Treat (MITT) population includes all randomized participants who received at least one infusion and had both screening and post-baseline radiographic assessments. Patients with missing data are classified as progressing||Percentage of Participants|||Number
719644|NCT00299104|Secondary|Change From Baseline in Modified Joint Space Narrowing (JSN) Score at Week 24|Joint Space Narrowing is the sum of joint scores collected for 42 joints and has a range of 0 to 168. A score of 0 would indicate no change and higher scores represent a worsening of joint space narrowing.|Baseline, Week 24|Participants from the modified intent-to-treat population (includes patients with a screening and at least one post-baseline radiographic evaluation, grouped as randomized) with data available at Week 24 for analysis.||Score on a scale||Standard Deviation|Mean
719645|NCT00299104|Secondary|Change From Baseline in the Total Erosion Score at Week 24|Total Erosion Score is determined by evaluation of fourteen sites in each wrist and hand and six joints in each foot using an eight-point scale from 0 (normal: no erosions) to 3.5 (Very severe; erosions of 100% of the articular surfaces. The Total Erosion Score at Week 24 - Total Erosion Score at baseline is calculated.|Baseline, Week 24|Participants from the modified intent-to-treat population (includes patients with a screening and at least one post-baseline radiographic evaluation, grouped as randomized) who had data available at Week 24 for analysis.||Score on a scale||Standard Deviation|Mean
719646|NCT00299104|Secondary|Change From Baseline in the Modified Total Sharp Score at Week 24|The modified total sharp score is the sum of the erosion score (ES) and the joint space narrowing (JSN) score and has a range of 0 to 398. The ES is the sum of joint scores collected for 46 joints and has a range of 0 to 230. The JSN is the sum of joint scores collected for 42 joints and has a range of 0 to 168. A score of 0 would indicate no change and higher scores represent a worsening of joint erosions and joint space narrowing.|Baseline, Week 24|Participants from the Modified Intent to Treat (MITT) population includes all randomized participants who received at least one infusion and had both screening and post-baseline radiographic assessments at the given time point for analysis.||Score on a scale||Standard Deviation|Mean
719647|NCT00299104|Secondary|Change From Baseline in Modified Joint Space Narrowing (JSN) Score at Week 52|Rate of progression in structural joint damage (PJD) by change in modified joint space narrowing (JSN) from screening to Week 52. The JSN is the sum of joint scores collected for 42 joints and has a range of 0 to 168. A score of 0 would indicate no change and higher scores represent a worsening of joint space narrowing.|Baseline and week 52|Modified intent-to-treat population includes patients with a screening and at least one post-baseline radiographic evaluation, grouped as randomized. Linear interpolation/extrapolation used for missing data.||Score on a scale||Standard Deviation|Mean
719648|NCT00299104|Secondary|Percentage of Patients Without Radiographic Progression in Total Erosion Score at Week 52|No radiographic progression is defined as a change in the total erosion score at Week 52 of less than or equal to zero.|Baseline, Week 52|Modified intent-to-treat population includes patients with a screening and at least one post-baseline radiographic evaluation, grouped as randomized. Linear interpolation/extrapolation used for missing data.||Percentage of Participants|||Number
719649|NCT00299104|Secondary|Percentage of Patients Without Radiographic Progression at Week 52|Percentage of patients without radiographic progression at Week 52, defined as change in total modified Sharp score (TMSS) <= 0. TMSS is the sum of the erosion score (ES) and the joint space narrowing (JSN) score and has a range of 0 to 398. The ES is the sum of joint scores collected for 46 joints and has a range of 0 to 230. The JSN is the sum of joint scores collected for 42 joints and has a range of 0 to 168. A score of 0 would indicate no change.|Baseline, Week 52|Modified intent-to-treat population includes patients with a screening and at least one post-baseline radiographic evaluation, grouped as randomized. Patients with missing data are classified as progressing.||Percentage|||Number
719650|NCT00299104|Secondary|Change From Baseline in Modified Sharp Erosion Score at Week 52|Rate of progression in structural joint damage (PJD) by change in modified Sharp erosion score from screening to Week 52. The ES is the sum of joint scores collected for 46 joints and has a range of 0 to 230. A score of 0 would indicate no change and higher scores represent a worsening of joint erosions.|Baseline and week 52|Modified intent-to-treat population includes patients with a screening and at least one post-baseline radiographic evaluation, grouped as randomized. Linear interpolation/extrapolation used for missing data.||Score on a scale||Standard Deviation|Mean
719651|NCT00299104|Primary|Change From Baseline in Modified Total Sharp Score (mTSS) From Screening at Week 52|Rate of progression in structural joint damage (PJD) by change in Total Modified Sharp Score (TMSS) from screening to Week 52 in the modified intent-to-treat (MITT) population. TMSS is the sum of the erosion score (ES) and the joint space narrowing (JSN) score and has a range of 0 to 398. The ES is the sum of joint scores collected for 46 joints and has a range of 0 to 230. The JSN is the sum of joint scores collected for 42 joints and has a range of 0 to 168. A score of 0 would indicate no change and higher scores represent a worsening of joint erosions and joint space narrowing.|Baseline and week 52|Modified intent-to-treat population includes patients with a screening and at least one post-baseline radiographic evaluation, grouped as randomized. Linear interpolation/extrapolation used for missing data.||Score on a scale||Standard Deviation|Mean
719652|NCT00299130|Post-Hoc|Percentage of Participants With Low Immunoglobulin Concentrations Pre- and Post-Rituximab Treatment|A low immunoglobulin concentration was defined as a concentration below the lower level of normal.|Baseline (pre-rituximab), Beginning of the safety follow-up period to the end of the study (approximately 6 years) (post-rituximab)|"Safety follow-up population: All participants who were randomized and received any part of a rituximab infusion. Number of participants analyzed = participants with available data. N indicates the number of participants with non-missing data at each time point."||Percentage of participants|||Number
719653|NCT00299130|Post-Hoc|Time to Repletion of Peripheral CD19+ B-cells|Peripheral CD19+ B-cell repletion was defined as a CD19+ B-cell count that returned to the Baseline value or returned to ≥ the lower limit of normal, whichever was lower.|Beginning of the first infusion (Day 1) in the last treatment cycle until repletion or the end of the study (approximately 6.5 years)|Extended safety follow-up population: All participants who were randomized, received any part of a rituximab infusion, and entered the extended safety follow-up period.||Weeks||95% Confidence Interval|Median
719654|NCT00299130|Secondary|Percentage of Participants With an ACR70 Response at Week 48|"To achieve an ACR70 required at least a 70% improvement compared with baseline in both tender joint counts (68 joints assessed for tenderness) and swollen joint counts (66 joints assessed for swelling), as well as a 70% improvement in three of the following five additional measurements:
Physician's global assessment of disease activity (assessed using a 100 mm Visual Analog Scale [VAS]);
Patient's global assessment of disease activity (assessed using a 100 mm VAS);
Patient's assessment of pain (assessed using a 100 mm VAS);
Health Assessment Questionnaire (HAQ; a patient completed questionnaire consisting of 20 questions, scored from 0-3);
Acute phase reactant: C-reactive protein (CRP) or, if CRP was missing, erythrocyte sedimentation rate (ESR).
Participants who withdrew prematurely from the study prior to Week 48, who received rescue therapy or had insufficient data in order to calculate a clinical response were considered to be non-responders."|Baseline and Week 48|Intent to treat population. ACR was calculated using LOCF values for each component. Participants who withdrew prior to Week 48, received rescue therapy or had insufficient data to calculate ACR were considered non-responders.||percentage of participants|||Number
719655|NCT00299130|Secondary|Percentage of Participants With an ACR50 Response at Week 48|"To achieve an ACR50 required at least a 50% improvement compared with Baseline in both tender joint counts (68 joints assessed for tenderness) and swollen joint counts (66 joints assessed for swelling), as well as a 50% improvement in three of the following five additional measurements:
Physician's global assessment of disease activity (assessed using a 100 mm Visual Analog Scale [VAS]);
Patient's global assessment of disease activity (assessed using a 100 mm VAS);
Patient's assessment of pain (assessed using a 100 mm VAS);
Health Assessment Questionnaire (HAQ; a patient completed questionnaire consisting of 20 questions, scored from 0-3);
Acute phase reactant: C-reactive protein (CRP) or, if CRP was missing, erythrocyte sedimentation rate (ESR).
Participants who withdrew prematurely from the study prior to week 48, who received rescue therapy or had insufficient data in order to calculate a clinical response were considered to be non-responders."|Baseline and Week 48|Intent to treat population. ACR was calculated using LOCF values for each component. Participants who withdrew prior to Week 48, received rescue therapy or had insufficient data to calculate ACR were considered non-responders.||percentage of participants|||Number
719656|NCT00299130|Secondary|Percentage of Participants With DAS28-ESR Low Disease Activity Score and Clinical Remission at Week 48|"The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables:
The number of swollen and tender joints assessed using the 28-joint count;
Erythrocyte sedimentation rate (ESR);
Patient's global assessment of disease activity measured on a 100 mm visual analog scale.
The DAS28 score ranges from zero to ten. DAS28 above 5.1 indicates high disease activity.
Low disease activity is defined by a DAS28 score less than or equal to 3.2. Remission is defined by a DAS28 score less than 2.6."|Week 48|Intent to treat population including participants with available data. DAS28 was calculated using last observation carried forward values for each of the component variables. If any of the components were missing then the DAS28 value will be missing.||percentage of participants|||Number
719694|NCT00299416|Secondary|Feasibility: Time Required to Reach the Target Core Temperature or Lowest Tolerated Temperature, Stability of Patient Temperature, Control of Rewarming,|Hypothermia will be maintained for 24 hours, afterward, the patient will be rewarmed, gradually, over 12 hours to 36.5C.|rewarming over 12 hours until 36.5C has been achieved||||||
719657|NCT00299130|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Response at Week 48|"A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score.
A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 3.2.
A Moderate Response is defined as either:
an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 score of less than or equal to 5.1 or,
an improvement (decrease) in the DAS28 of more than 1.2 and attainment of a DAS28 score of greater than 3.2.
No Response is defined as either an improvement (decrease) in the DAS28 of less than or equal to 0.6, or an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 score of 5.1 or higher."|Baseline and Week 48|Intent-to-treat population. LOCF was used for the individual components of the DAS-28. Non-responder imputation was used. Patients who withdrew prior to week 48, who received rescue therapy or had insufficient data in order to calculate a EULAR response were considered non-responders.||percentage of participants|||Number
719658|NCT00299130|Secondary|Percentage of Participants With HAQ-DI Improved, Unchanged or Worsened at Week 48|"The Stanford Health Assessment Questionnaire disability index is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants choose from four response categories, ranging from 'without any difficulty' (Score=0) to 'unable to do' (Score=3). The overall score is the average of each of the 8 category scores and ranges from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A negative change from baseline score indicates an improvement.
Improved HAQ-DI is defined as a change from Baseline score less than or equal to -0.22.
An Unchanged HAQ-DI is defined as a change from Baseline score greater than -0.22 and less than 0.22.
A worsened HAQ-DI score is defined as a change from Baseline score of greater than or equal to 0.22."|Baseline and Week 48|Intent-to-treat population including participants with available data. LOCF was used.||percentage of participants|||Number
719659|NCT00299130|Secondary|Percentage of Participants With HAQ-DI Improved, Unchanged or Worsened at Week 24|"The Stanford Health Assessment Questionnaire disability index is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants choose from four response categories, ranging from 'without any difficulty' (Score=0) to 'unable to do' (Score=3). The overall score is the average of each of the 8 category scores and ranges from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A negative change from baseline score indicates an improvement.
Improved HAQ-DI is defined as a change from Baseline score less than or equal to -0.22.
An Unchanged HAQ-DI is defined as a change from Baseline score greater than -0.22 and less than 0.22.
A worsened HAQ-DI score is defined as a change from Baseline score of greater than or equal to 0.22."|Baseline and Week 24|Intent-to-treat population including participants with available data. LOCF was used.||percentage of participants|||Number
719660|NCT00299130|Secondary|Percentage of Participants With DAS28-ESR Low Disease Activity Score and Clinical Remission at Week 24|"The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables:
The number of swollen and tender joints assessed using the 28-joint count;
Erythrocyte sedimentation rate (ESR);
Patient's global assessment of disease activity measured on a 100 mm visual analog scale.
The DAS28 score ranges from zero to ten. DAS28 above 5.1 indicates high disease activity.
Low disease activity is defined by a DAS28 score less than or equal to 3.2. Remission is defined by a DAS28 score less than 2.6."|Week 24|Intent to treat population with available data. DAS28 was calculated using last observation carried forward values for each of the component variables. If any of the components were missing then the DAS28 value will be missing. Number of participants analyzed = participants who were evaluable for this outcome.||percentage of participants|||Number
719661|NCT00299130|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Scores|"The FACIT-Fatigue questionnaire is a self-administered patient questionnaire that consists of 13 questions designed to measure the degree of fatigue experienced by participants in the previous 7 days. Participants respond to the questions using a value in the range of 0 (not at all) to 4 (very much). The scale score is computed by summing the item scores, after reversing those items that are worded in the negative direction. The FACIT-Fatigue subscale score ranges from 0 to 52, where higher scores represent less fatigue.
A positive change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population, LOCF was used. N indicates the number of participants with non-missing data at each time point."||scores on a scale||Standard Deviation|Mean
719662|NCT00299130|Secondary|Change From Baseline in Short Form 36 Health Survey (SF-36) Emotional Role Limitations Domain Score|"The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning.
A positive change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population. N indicates the number of participants with non-missing data at each time point."||scores on a scale||Standard Deviation|Mean
719663|NCT00299130|Secondary|Change From Baseline in Short Form 36 Health Survey (SF-36) Social Functioning Domain Score|"The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning.
A positive change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population. N indicates the number of participants with non-missing data at each time point."||scores on a scale||Standard Deviation|Mean
719712|NCT00299975|Secondary|Passing of Gas|It was a 7-point ordinal scale from 0=not at all to 6=very severe.|Baseline(Week2), Within treatment(Week6), End of treatment(Week10) & End of follow-up(Week18)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.||Units on a scale||Standard Deviation|Mean
719664|NCT00299130|Secondary|Change From Baseline in Short Form 36 Health Survey (SF-36) Vitality Domain Score|"The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning.
A positive change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population. N indicates the number of participants with non-missing data at each time point."||scores on a scale||Standard Deviation|Mean
719665|NCT00299130|Secondary|Change From Baseline in Short Form 36 Health Survey (SF-36) Mental Health Domain Score|"The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning.
A positive change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population. N indicates the number of participants with non-missing data at each time point."||scores on a scale||Standard Deviation|Mean
719666|NCT00299130|Secondary|Change From Baseline in Short Form 36 Health Survey (SF-36) Physical Role Limitations Domain Score|"The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning.
A positive change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population. N indicates the number of participants with non-missing data at each time point."||scores on a scale||Standard Deviation|Mean
719667|NCT00299130|Secondary|Change From Baseline in Short Form 36 Health Survey (SF-36) Physical Functioning Domain Score|"The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning.
A positive change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population. N indicates the number of participants with non-missing data at each time point."||scores on a scale||Standard Deviation|Mean
719668|NCT00299130|Secondary|Change From Baseline in Short Form 36 Health Survey (SF-36) Bodily Pain Domain Score|"The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning.
A positive change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population. N indicates the number of participants with non-missing data at each time point."||scores on a scale||Standard Deviation|Mean
719669|NCT00299130|Secondary|Change From Baseline in Short Form 36 Health Survey (SF-36) General Health Domain Score|"The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning.
A positive change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population. N indicates the number of participants with non-missing data at each time point."||scores on a scale||Standard Deviation|Mean
719670|NCT00299130|Secondary|Percent Change From Baseline in Short Form 36 Health Survey (SF-36) Summary Scores (Physical and Mental Components)|"The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions split into two major components: physical health and mental health. Under physical health are the following four domains: physical health, bodily pain, physical functioning and physical role limitations. Under the mental health domain there are four domains; mental health, vitality, social functioning, and emotional role limitation. The individual domain scores are aggregated to derive a physical-component summary score and a mental-component summary score which range from 0 to 100, with higher scores indicating a better level of functioning.
The percentage change from baseline at each post-baseline visit was calculated as:
[(post-baseline value minus baseline value) divided by Baseline value]*100.
A positive percentage change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population, LOCF was used. N indicates the number of participants with non-missing data at each time point."||percent change||Standard Deviation|Mean
719671|NCT00299130|Secondary|Percent Change From Baseline in Erythrocyte Sedimentation Rate|"Erythrocyte sedimentation rate (ESR) indirectly measures how much inflammation is in the body. A higher ESR is indicative of increased inflammation.
The percentage change from baseline at each post-baseline visit was calculated as:
[(post-baseline value minus baseline value) divided by Baseline value]*100.
A negative percentage change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population, LOCF was used. N indicates the number of participants with non-missing data at each time point."||percent change||Standard Deviation|Mean
719672|NCT00299130|Secondary|Percent Change From Baseline in C-Reactive Protein|"C-Reactive Protein (CRP) was measured from blood samples by a central laboratory as a marker for inflammation.
The percentage change from baseline at each post-baseline visit was calculated as:
[(post-baseline value minus baseline value) divided by Baseline value]*100.
A negative percentage change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population, LOCF was used. N indicates the number of participants with non-missing data at each time point."||percent change||Standard Deviation|Mean
719695|NCT00299416|Primary|Number of Participants With Symptomatic Intracerebral Hemorrhage|Symptomatic intracerebral hemorrhages were measured by a full NIHSS(National Institute of Health Stroke Scale) prior to caffeinol & hypothermia,at the end of hypothermia & rewarming, 24 hrs after stroke onset, daily during hospitalization,& at the 90 day follow-up visit. In addition, modified NIHSS were done hourly during the 24 hr hypothermia period & 12 hr rewarming period. At the end of rewarming an MRI was obtained to verify if hemorrhages or neurologic deteriorations were present.NIHSS scores severity of stroke on 11 items;more points given for greater deficiencies(range 0-42,0=normal)|from pre-dosage to 90 day followup|Number of participants were determined by intention to treat. We did not use any imputation technique.||participants|||Number
719673|NCT00299130|Secondary|Percent Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score|"The Stanford Health Assessment Questionnaire disability index is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants choose from four response categories, ranging from 'without any difficulty' (Score=0) to 'unable to do' (Score=3). The overall score is the average of each of the 8 category scores and ranges from 0 to 3, where zero represents no disability and three very severe, high-dependency disability.
The percentage change from baseline at each post-baseline visit was calculated as:
[(post-baseline value minus baseline value) divided by Baseline value]*100.
A negative percentage change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population, LOCF was used. N indicates the number of participants with non-missing data at each time point."||percent change||Standard Deviation|Mean
719674|NCT00299130|Secondary|Percent Change From Baseline in Physician’s Global Assessment of Disease Activity|"The physician’s assessment of the participant's current disease activity on a 100 mm horizontal VAS, where the left-hand extreme of the line (0 mm) was described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme (100 mm) as maximum disease activity.
The percentage change from baseline at each post-baseline visit was calculated as:
[(post-baseline value minus baseline value) divided by Baseline value]*100.
A negative percentage change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population, LOCF was used. N indicates the number of participants with non-missing data at each time point."||percent change||Standard Deviation|Mean
719675|NCT00299130|Secondary|Percent Change From Baseline in Patient’s Pain Assessment|"The participant’s assessment of their current level of pain on a 100 mm horizontal visual analog scale (VAS), where the left-hand extreme of the line (0 mm) was described as no pain and the right-hand extreme (100 mm) as unbearable pain.
The percentage change from baseline at each post-baseline visit was calculated as:
[(post-baseline value minus baseline value) divided by Baseline value]*100.
A negative percentage change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population, LOCF was used. N indicates the number of participants with non-missing data at each time point."||percent change||Standard Deviation|Mean
719676|NCT00299130|Secondary|Percent Change From Baseline in Patient's Global Assessment of Disease Activity|"The participant's overall assessment of their current disease activity measured on a 100 mm horizontal visual analog scale (VAS). The left-hand extreme of the line (0 mm) was described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme (100 mm) as maximum disease activity (maximum arthritis disease activity).
The percentage change from baseline at each post-baseline visit was calculated as:
[(post-baseline value minus baseline value) divided by Baseline value]*100.
A negative percentage change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population, LOCF was used. N indicates the number of participants with non-missing data at each time point."||percent change||Standard Deviation|Mean
719677|NCT00299130|Secondary|Percent Change From Baseline in Tender Joint Count|"Sixty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination.
The percentage change from baseline at each post-baseline visit was calculated as:
[(post-baseline value minus baseline value) divided by Baseline value]*100.
A negative percentage change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population, LOCF was used. N indicates the number of participants with non-missing data at each time point."||percent change||Standard Deviation|Mean
719678|NCT00299130|Secondary|Percent Change From Baseline in Swollen Joint Count|"Sixty-six joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination.
The percentage change from baseline at each post-baseline visit was calculated as:
[(post-baseline value minus baseline value) divided by Baseline value]*100.
A negative percentage change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population, LOCF was used. N indicates the number of participants with non-missing data at each time point."||percent change||Standard Deviation|Mean
719679|NCT00299130|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Response at Week 24|"A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS28 score. The DAS28 score ranges from 0-10, with higher scores indicating more disease activity.
A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score of less than or equal to 3.2.
A Moderate Response is defined as either:
an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 from Baseline and attainment of a DAS28 score of less than or equal to 5.1 or,
an improvement (decrease) in the DAS28 of more than 1.2 from Baseline and attainment of a DAS28 score of greater than 3.2.
No Response is defined as either an improvement (decrease) in the DAS28 of less than or equal to 0.6, or an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 of more than 5.1."|Baseline and Week 24|Intent-to-treat population. LOCF was used for the individual components of the DAS-28. Non-responder imputation was used. Participants who withdrew prior to Week 24, who received rescue therapy or had insufficient data in order to calculate a EULAR response were considered non-responders.||percentage of participants|||Number
719680|NCT00299130|Secondary|Change From Baseline in Disease Activity Score (DAS28-ESR) at Week 24|"The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables:
The number of swollen and tender joints assessed using the 28-joint count;
Erythrocyte sedimentation rate (ESR);
Patient's global assessment of disease activity measured on a 100 mm visual analog scale.
The DAS28 score ranges from zero to ten. A DAS28 score above 5.1 means high disease activity whereas a DAS28 less than or equal to 3.2 indicates low disease activity. Remission is achieved by a DAS28 lower than 2.6."|Baseline and Week 24|Intent to treat population with available data. DAS28 was calculated using last observation carried forward values for each of the component variables. If any of the components were missing then the DAS28 value will be missing.||scores on a scale||Standard Deviation|Mean
719708|NCT00299975|Secondary|Serum Glutamic Pyruvic Transaminase(SGPT) Level||Pre-treatment(Week2) & Post-treatment(Week10)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.||U/L||Standard Deviation|Mean
719681|NCT00299130|Secondary|Percentage of Participants With an ACR70 Response at Week 24|"To achieve an ACR70 required at least a 70% improvement compared with Baseline in both tender joint counts (68 joints assessed for tenderness) and swollen joint counts (66 joints assessed for swelling), as well as a 70% improvement in three of the following five additional measurements:
Physician's global assessment of disease activity (assessed using a 100 mm Visual Analog Scale [VAS]);
Patient's global assessment of disease activity (assessed using a 100 mm VAS);
Patient's assessment of pain (assessed using a 100 mm VAS);
Health Assessment Questionnaire (HAQ; a patient completed questionnaire consisting of 20 questions, scored from 0-3);
Acute phase reactant: C-reactive protein (CRP) or, if CRP was missing, erythrocyte sedimentation rate (ESR).
Participants who withdrew prematurely from the study prior to Week 24, who received rescue therapy or had insufficient data in order to calculate a clinical response were considered to be non-responders."|Baseline and Week 24|Intent to treat population. ACR was calculated using LOCF values for each component. Participants who withdrew prior to Week 24, received rescue therapy or had insufficient data to calculate ACR were considered non-responders.||percentage of participants|||Number
719682|NCT00299130|Secondary|Percentage of Participants With an ACR50 Response at Week 24|"To achieve an ACR50 required at least a 50% improvement compared with Baseline in both tender joint counts (68 joints assessed for tenderness) and swollen joint counts (66 joints assessed for swelling), as well as a 50% improvement in three of the following five additional measurements:
Physician's global assessment of disease activity (assessed using a 100 mm Visual Analog Scale [VAS]);
Patient's global assessment of disease activity (assessed using a 100 mm VAS);
Patient's assessment of pain (assessed using a 100 mm VAS);
Health Assessment Questionnaire (HAQ; a patient completed questionnaire consisting of 20 questions, scored from 0-3);
Acute phase reactant: C-reactive protein (CRP) or, if CRP was missing, erythrocyte sedimentation rate (ESR).
Participants who withdrew prematurely from the study prior to Week 24, who received rescue therapy or had insufficient data in order to calculate a clinical response were considered to be non-responders."|Baseline and Week 24|Intent to treat population. ACR was calculated using LOCF values for each component. Participants who withdrew prior to Week 24, received rescue therapy or had insufficient data to calculate ACR were considered non-responders.||percentage of participants|||Number
719683|NCT00299130|Primary|Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 24|"To achieve an ACR20 required at least a 20% improvement compared with Baseline in both tender joint counts (68 joints assessed for tenderness) and swollen joint counts (66 joints assessed for swelling), as well as a 20% improvement in three of the following five additional measurements:
Physician's global assessment of disease activity (assessed using a 100 mm Visual Analog Scale [VAS]);
Patient's global assessment of disease activity (assessed using a 100 mm VAS);
Patient's assessment of pain (assessed using a 100 mm VAS);
Health Assessment Questionnaire (HAQ; a patient completed questionnaire consisting of 20 questions, scored from 0-3);
Acute phase reactant: C-reactive protein (CRP) or, if CRP was missing, erythrocyte sedimentation rate (ESR).
Participants who withdrew prematurely from the study prior to Week 24, who received rescue therapy or had insufficient data in order to calculate a clinical response were considered to be non-responders."|Baseline and Week 24|Intent to treat population included all randomized participants who received at least 1 or part of an infusion. ACR was calculated using the last observation carried forward (LOCF) values for each component. Participants who withdrew prior to week 24, received rescue therapy or had insufficient data to calculate ACR were considered non-responders.||percentage of participants|||Number
719684|NCT00299156|Primary|Participants With a Complete Remission (CR)|"Complete Remission (CR): Normalization of the peripheral blood and bone marrow with <5% bone marrow blasts, a peripheral blood granulocyte count > (1.0 x 109/ L, and a platelet count > 100 x 109/L).
Partial Remission: as above except for the presence of 6-15% marrow blasts, or 50% reduction if <15% at start of treatment.
Hematologic Improvement: meets all criteria for CR except for platelet recovery to >100 x 109/L.
Clinical Benefit: Platelets increase by 50% and to above 30 x 109/L untransfused (if lower than that pretherapy); or granulocytes increase by 100% and to above 109/L (if lower than that pretherapy); or hemoglobin increase by 2 g/dl; or transfusion independent; or splenomegaly reduction by > 50%; or monocytosis reduction by > 50% if pretreatment > 5 x 109/L."|After 3 courses of treatment, up to 24 weeks.|||Participants|||Number
719685|NCT00299221|Secondary|Mean ISHLT Biopsy Score Over First Year Post-transplant|Mean ISHLT biopsy score Biopsies of the heart may be various grades and each is assigned a numerical score. Grade 0 is 0 points, 1A = 1, 1B = 2, grade 2 = 3, grade 3A = 4, Grade 3B = 5, and grade 4 = 6 units. The mean biopsy score is the numeric average of the biopsy scores for the first 6 post-transplant months. Best value is 0, worst score is 6.|1 year|all pts, Intention to treat||units on a scale||Standard Deviation|Mean
719686|NCT00299221|Secondary|Number of Patients With Allograft Vasculopathy (CAD) at One Year Post Transplant|Number of patients diagnosed with allograft vasculopathy / coronary artery disease (CAD) at one year post transplant|1 year|Percent of patients with allograft CAD at one year post-transplant||patients|||Number
719687|NCT00299221|Secondary|Number of Patients With Cytomegalovirus (CMV) at One Year Post-transplant|Number of patients developing cytomegalovirus disease by 1 year post-transplant|1 year|all patients||participants|||Number
719688|NCT00299221|Secondary|Percent of Patients Alive at One Year Post-transplant|Percent of patients alive at one year post-transplant. In other words, all cause mortality over time|1 year|all pts, intention to treat||percent of participants|||Number
719689|NCT00299221|Primary|Mean International Society for Heart and Lung Transplantation Biopsy Score Over the First 6 Months Post-transplantation|Mean ISHLT biopsy score Biopsies of the heart may be various grades and each is assigned a numerical score. Grade 0 is 0 points, 1A = 1, 1B = 2, grade 2 = 3, grade 3A = 4, Grade 3B = 5, and grade 4 = 6 units. The mean biopsy score is the numeric average of the biopsy scores for the first 6 post-transplant months. Best value is 0, worst score is 6.|6 months|all pts, intention to treat||units on a scale||Standard Deviation|Mean
719690|NCT00299416|Primary|Number of Participants With Cardiorespiratory Failure|The possibility of cardiorespiratory failure was monitored every 30 minutes during the 24 hour hypothermia period based on vitals signs and oxygen saturation.|every 30 minutes during hypothermia induction|||participants|||Number
719691|NCT00299416|Primary|Number of Participants With Catheter Related Complications During Hypothermia & Rewarming|Catheter-related complications assessed whether participants had bleeding (major hemorrhaging) that required a blood transfusion, this was determined by labs. Participants were monitored for infections every hour during vital signs in the 24 hour hypothermia phase and 12 hour rewarming phase.|over 36 hour period|||participants|||Number
719696|NCT00299546|Secondary|Health Assessment Questionnaire (HAQ) Score at Week 24|Improvement from baseline in HAQ score at Week 24. This 20-question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area based on the worst score from the questions that pertain to that task. The HAQ score is determined by the average of the 8 scores; HAQ ranges from 0 to 3.|From Baseline to Week 24|Randomized participants (excluding 1 site). Missing scores imputed by Last Observation Carried Forward. Week 16 scores were used for participants with change in study treatment.||scores on a scale||Inter-Quartile Range|Median
719697|NCT00299546|Secondary|American College of Rheumatology (ACR) 20 at Week 24|Number of patients who achieved ACR 20 response at Week (Wk) 24. ACR 20 response is an improvement of >= 20% from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments ( patient's assessment of pain visual analog scale (VAS), patient's global assessemnt of disease activity VAS scale, Physician's global assessment of disease activity VAS scale,HAQ and CRP)|From Baseline to Week 24|Randomized participants (excluding 1 site). Participants considered non-responders if used any prohibited medications or discontinued SC study agent due to lack of efficacy. Missing ACR components imputed by LOCF unless all components were missing; in which case considered non-responders. Wk 16 ACR response used for change in study tx.||participants|||Number
719698|NCT00299546|Secondary|Disease Activity Index Score 28 (DAS 28) (Using C-reactive Protein) Response at Week 14|DAS 28 using C-reactive protein (CRP) is an index to measure disease activity in participants with rheumatoid arthritis which combines tender joint count (28 joints), swollen joint count (28 joints), CRP value, and participant’s global assessment of disease activity (using a Visual Analog Scale of 0 to 100 mm). The DAS 28 score ranges from 0 (best) to 10 (worst).|Week 14|Randomized participants (excluding 1 site). Participants considered non-responders if used any prohibited medications or discontinued subcutaneous study agent due to lack of efficacy. Missing DAS 28 components imputed by Last Observation Carried Forward unless all components were missing; in which case considered non-responders.||participants|||Number
719699|NCT00299546|Secondary|American College of Rheumatology (ACR) 50 Response at Week 14|Number of patients who achieved an ACR 50 response at Week (Wk) 14. ACR 50 response is an improvement of >= 50% from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments ( patient's assessment of pain visual analog scale (VAS), patient's global assessemnt of disease activity VAS scale, Physician's global assessment of disease activity VAS scale, Health Assessment Questionnaire and C-reactive protein).|Week 14|Randomized participants (excluding 1 site). Participants considered non-responders if used any prohibited medications or discontinued subcutaneous study agent due to lack of efficacy. Missing ACR components imputed by Last Observation Carried Forward unless all ACR components were missing; in which case considered non-responders.||participants|||Number
719700|NCT00299546|Primary|American College of Rheumatology (ACR) 20 Response at Week 14.|ACR 20 response is an improvement of >= 20% from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments ( patient's assessment of pain visual analog scale (VAS), patient's global assessment of disease activity VAS scale, Physician's global assessment of disease activity VAS scale, Health Assessment Questionnaire and C-reactive protein)|Week 14|Randomized participants (excluding 1 site). Participants considered non-responders if used any prohibited medications or discontinued subcutaneous study agent due to lack of efficacy. Missing ACR components imputed by Last Observation Carried Forward unless all ACR components were missing; in which case considered non-responders.||participants|||Number
719701|NCT00299689|Secondary|Overall Survival||All cause mortality||||||
719702|NCT00299689|Primary|Positive Response Defined as Clinical Complete Response, Partial Response or Stable Disease (Persisting for at Least 4 Weeks) as Measure by Modified RECIST Criteria||2 weeks after completion of second cycle|||participants|||Number
719703|NCT00299702|Primary|Time in Remission|Time in remission for an individual subject was defined as the length of time (in days) that the remission criteria were maintained during the trial. Remission was defined as the simultaneous attainment of a score of 3 (mild), 2 (minimal), or 1 (absent) for all the following individual items from Positive and Negative Syndrome Scale (PANSS): delusions (P1), concept disorganization (P2), hallucinatory behavior (P3), unusual thought content (G9), mannerisms and posturing (G5), blunted affect (N1), passive/apathetic social withdrawal (N4), and lack of spontaneity and flow of conversation (N6).|Day 1 to last PANSS measurement|explanatory ITT analysis data set (eITT) contains all subjects who had at least one administration of study drug as well as at least one follow-up efficacy measurement; includes assessments while the subject is on study drug.||days||Standard Deviation|Mean
719704|NCT00299702|Primary|Time to Relapse|Time to relapse was defined as the number of days from the date of first dose to the date of relapse, as determined by the Relapse Monitoring Board.|Day 1 to relapse|explanatory ITT analysis data set (eITT) contains all subjects who had at least one administration of study drug as well as at least one follow-up efficacy measurement; includes assessments while the subject is on study drug.||days||95% Confidence Interval|Median
719705|NCT00299741|Secondary|Objective Responses, Defined as the Number of Participants With Complete or Partial Response|The response rate is defined by Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions as assessed by radiographic evaluation. Complete response(CR): disappearance of all target lesions; Partial response(PR): >=30% decrease in the sum of the longest diameter of target lesions; Overall response = CR + PR.|Participants were followed until the time of disease progression, an average of 12 weeks|||participants|||Number
719706|NCT00299741|Primary|The Number of Men With Advanced Prostate Cancer Treated With Sunitinib Who Have a Prostate Specific Antigen (PSA) Response|Prostate specific antigen (PSA) responses, defined as the number of men who exhibit PSA decline of at least 50% that is confirmed by a second PSA value 4 or more weeks later (PSA Working Group I Criteria)|were followed until disease progression, an average of 12 weeks|All participants analyzed||participants|||Number
719707|NCT00299975|Secondary|Serum Glutamic Oxaloacetic Transaminase(SGOT) Level||Pre-treatment(Week2) & Post-treatment(Week10)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.||U/L||Standard Deviation|Mean
719713|NCT00299975|Secondary|Sensation of Abdominal Pain/Cramping|It was a 7-point ordinal scale from 0=not at all to 6=very severe.|Baseline(Week2), Within treatment(Week6), End of treatment(Week10) & End of follow-up(Week18)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.||Units on a scale||Standard Deviation|Mean
719714|NCT00299975|Secondary|Sensation of Bloating|It was a 7-point ordinal scale from 0=not at all to 6=very severe.|Baseline(Week2), Within treatment(Week6), End of treatment(Week10) & End of follow-up(Week18)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.||Units on a scale||Standard Deviation|Mean
719715|NCT00299975|Secondary|Incomplete of Evacuation|It was a 7-point ordinal scale from 0=not at all to 6=very severe.|Baseline(Week2), Within treatment(Week6), End of treatment(Week10) & End of follow-up(Week18)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.||Units on a scale||Standard Deviation|Mean
719716|NCT00299975|Secondary|Sensation of Straining|It was a 7-point ordinal scale from 0=not at all to 6=very severe.|Baseline(Week2), Within treatment(Week6), End of treatment(Week10) & End of follow-up(Week18)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.||Units on a scale||Standard Deviation|Mean
719717|NCT00299975|Secondary|Severity of Constipation|It was a 7-point ordinal scale from 0=not at all to 6=very severe.|Baseline(Week2), Within treatment(Week6), End of treatment(Week10) & End of follow-up(Week18)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.||Units on a scale||Standard Deviation|Mean
719718|NCT00299975|Secondary|Global Symptoms Improvement|"Participants were asked to rate their impression of change in constipation by comparing with their baseline (Wk2) at the visits during the treatment (Wk6), end of treatment (Wk10) and end of follow-up (Wk18) with scores from 0 to 6 represented markedly worse or better respectively. The response categories were collapsed to simply improved for score 4 to 6, same for score 3 or worse for score 0 to 2."|Week6, 10 & 18|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.||participants|||Number
719719|NCT00299975|Secondary|Complete Spontaneous Bowel Movement (CSBM)|CSBM referred to the feeling that defecation led to complete passage of stool rather than partial or incomplete evacuation without the use of any laxative or enema within 24 hours.|Baseline(Week1-2), Within treatment(Week3-10) & Within follow-up(Week11-18)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.||movements per week||Standard Deviation|Mean
719720|NCT00299975|Secondary|Bowel Movement||Baseline(Week1-2), Within treatment(Week3-10) & Within follow-up(Week11-18)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.||movements per week||Standard Deviation|Mean
719721|NCT00299975|Secondary|Responder for Complete Spontaneous Bowel Movement (CSBM)|Participants with a mean increase of CSBM>=1 movement per week compared with the last 14 days of the run-in period were defined as responders. CSBM referred to the feeling that defecation led to complete passage of stool rather than partial or incomplete evacuation without the use of any laxative or enema within 24 hours.|Week11-18|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.||participants|||Number
719722|NCT00299975|Primary|Responder for Complete Spontaneous Bowel Movement (CSBM)|Participants with a mean increase of CSBM>=1 movement per week compared with the last 14 days of the run-in period were defined as responders.CSBM referred to the feeling that defecation led to complete passage of stool rather than partial or incomplete evacuation without the use of any laxative or enema within 24 hours.|Week3-10|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.||participants|||Number
719723|NCT00300235|Secondary|Assessment of General Patient and Parent Understanding of Priapism as a Complication of Sickle Cell Disease Gained From Completion of Protocol|Assessment of general patient and parent understanding of priapism as a complication of sickle cell disease gained from completion of protocol.|Cross-sectional single survey visit||||||
719724|NCT00300235|Secondary|Descriptive Comparison of the Prevalence of Priapism in Males With Sickle Cell Anemia to That Described in Older Patients With Other Sickle Hemoglobinopathies|Descriptive comparison of the prevalence of priapism in males with sickle cell anemia to that described in older patients with other sickle hemoglobinopathies.|Cross-sectional single survey visit||||||
719725|NCT00300235|Secondary|Characterization of Priapism in Males With Sickle Cell Anemia With Reference to Time of Onset, Duration of Events, Frequency of Episodes, Precipitating or Associated Activities, Treatment Modalities Used, and Outcome of Treatments|Characterization of priapism in males with sickle cell anemia with reference to time of onset, duration of events, frequency of episodes, precipitating or associated activities, treatment modalities used, and outcome of treatments.|Cross-sectional single survey visit||||||
719726|NCT00300235|Primary|Enumeration of the Prevalence of Priapism in Males With Sickle Cell Anemia and Sickle Beta Zero Thalassemia.|"Subject responded YES to survey Question Have you ever had priapism?. By diagnosis and age group. Enumeration of the prevalence of priapism in males with sickle cell anemia and sickle beta zero thalassemia."|At time of interview|All particpants who completed survey were analyzed.||participants|||Number
719727|NCT00300274|Secondary|Percentage of Participants With Biopsy-proven Acute Rejection (BPAR of ISHLT Grade ≥ 3A), Acute Rejection (AR) Associated With Hemodynamic Compromise (HDC), Graft Loss/Re-transplant and Death at Month 24|"Identification of acute rejections was based on the local pathologist's evaluation of endomyocardial biopsy slides.
Hemodynamic compromise was present if 1 or more of the following were met: Ejection fraction ≤ 30% or 25% lower than Baseline or Fractional shortening ≤ 20% or 25% lower than Baseline, and/ or use of inotropic treatment."|24 Months|Intent-to-treat population included all randomized participants.||Percentage of participants|||Number
719728|NCT00300274|Secondary|Renal Function Calculated by Glomerular Filtration Rate (GFR) at 24 Months|"GFR was calculated using the Modification of Diet and Renal Disease (MDRD) formula:
GFR [mL/min/1.73m^2] = 186.3*(C^-1.154)*(A^-0.203)*G*R
C is the serum concentration of creatinine [mg/dL] A is age [years] G=0.742 when gender is female, otherwise G=1 R=1.21 when race is black, otherwise R=1"|24 Months|Participants from the intent-to-treat population (all randomized participants) with data available for analysis.||mL/min/1.73^2||Standard Deviation|Mean
719729|NCT00300274|Secondary|Percentage of Participants With Graft Loss/Re-transplant, Death or Loss to Follow-up at 24 Months|Loss to follow-up for this composite endpoint included participants who did not experience graft loss/re-transplant or death and whose last day of contact was prior to Day 631 (start day of 24 Month visit window).|24 Months|Intent-to-treat population included all randomized participants.||Percentage of participants|||Number
719730|NCT00300274|Secondary|Percentage of Participants With Composite Efficacy Failure at 24 Months|"Composite efficacy failure was defined as Biopsy Proven Acute Rejection (BPAR) of International Society for Heart and Lung Transplantation grade ≥ 3A, Acute Rejection associated with Hemodynamic Compromise, Graft loss/Retransplant, Death or Loss to follow-up.
Identification of acute rejections was based on the local pathologist's evaluation of endomyocardial biopsy slides.
Hemodynamic compromise was present if 1 or more of the following were met: Ejection fraction ≤ 30% or 25% lower than Baseline or Fractional shortening ≤ 20% or 25% lower than Baseline and/or use of inotropic treatment."|24 Months|Intent-to-treat population included all randomized participants.||Percentage of participants|||Number
719731|NCT00300274|Secondary|Percentage of Participants With Biopsy-proven Acute Rejection (BPAR of ISHLT Grade ≥ 3A), Acute Rejection Associated With Hemodynamic Compromise (HDC), Graft Loss/Re-transplant and Death at Month 12|"Identification of acute rejections was based on the local pathologist's evaluation of endomyocardial biopsy slides.
Hemodynamic compromise was present if 1 or more of the following were met: Ejection fraction ≤ 30% or 25% lower than Baseline or Fractional shortening ≤ 20% or 25% lower than Baseline, and/or use of inotropic treatment."|12 Months|Intent-to-treat population includes all randomized participants.||Percentage of participants|||Number
719732|NCT00300274|Secondary|Percentage of Participants With Cardiac Allograft Vasculopathy (CAV) at Month 12|Cardiac allograft vasculopathy is defined as a 0.5 mm increase in maximum intimal thickness as measured by Intravascular Ultrasound (IVUS) in at least one matched slice between baseline and Month 12.|12 Months|IVUS population consisted of randomized patients who had a minimum of 11 matched slices between IVUS images from Baseline and from Month 12 (IVUS centers).||Percentage of participants|||Number
719733|NCT00300274|Secondary|Change From Baseline in the Average Maximum Intimal Thickness at Month 12|Maximum intimal thickness was assessed using Intravascular Ultrasound (IVUS). IVUS is a technique for taking ultrasound pictures of the wall of an artery from inside the artery itself. It shows the thickness of the artery wall and any narrowing of the artery.|Baseline, Month 12|IVUS population consisted of randomized patients who had a minimum of 11 matched slices between IVUS images from Baseline and from Month 12 (IVUS Centers).||mm||Standard Deviation|Mean
719734|NCT00300274|Secondary|Renal Function Measured by Glomerular Filtration Rate (GFR) at 12 Months|"GFR was calculated using the Modification of Diet and Renal Disease (MDRD) formula:
GFR [mL/min/1.73m^2] = 186.3*(C^-1.154)*(A^-0.203)*G*R where C is the serum concentration of creatinine [mg/dL] A is age [years] G=0.742 when gender is female, otherwise G=1 R=1.21 when race is black, otherwise R=1"|12 Months|Participants from the intent-to-treat population (all randomized participants) with data available for analysis.||mL/min/1.73^2||Standard Deviation|Mean
719735|NCT00300274|Secondary|Percentage of Participants With Graft Loss/Re-transplant, Death or Loss to Follow-up at 12 Months|Loss to follow-up for this composite endpoint included participants who did not experience graft loss/re-transplant or death and whose last day of contact was prior to Day 316 (start day of the Month 12 visit window).|12 Months|Intent-to-treat population included all randomized participants.||Percentage of participants|||Number
719736|NCT00300274|Primary|Percentage of Participants With Composite Efficacy Failure at 12 Months|"Composite efficacy failure was defined as Biopsy Proven Acute Rejection(BPAR) of International Society for Heart and Lung Transplantation(ISHLT) grade ≥3A, Acute Rejection associated with Hemodynamic Compromise, Graft loss/Retransplant, Death or Loss to follow-up.
Identification of acute rejection was based on the local pathologist's evaluation of endomyocardial biopsy slides.
Hemodynamic compromise was present if 1 or more of the following were met: Ejection fraction ≤30% or 25% lower than Baseline or Fractional shortening ≤20% or 25% lower than Baseline and/or use of inotropic treatment."|12 Months|Intent-to-treat population included all randomized participants.||Percentage of participants|||Number
719737|NCT00300365|Primary|Mean Increase in High Density Lipoprotein Cholesterol (HDL-C) at Baseline and 12 Weeks|Mean increase in HDL-C from baseline (week -4) to 12 weeks post randomization in non-diabetic subjects with low HDL-C and metabolic syndrome. After baseline, all subjects titrated niacin extended release (ER) to 2 grams (g) daily over 4 weeks. Subjects were also given 325 mg aspirin to take 30 minutes before the niacin ER. After 4 weeks, half of the subjects added blinded pioglitazone 30mg/day (milligrams/day) for 6 weeks followed by 45 mg/day for 6 weeks; the other half added placebo. HDL-C was was assessed at baseline and 12 weeks post randomization|Baseline, after 12 weeks of pioglitazone vs placebo|All subjects for whom HDL-C measurements were recorded at baseline (week -4) and 12 weeks post randomization to placebo, niacin ER, and aspirin or pioglitazone, niacin ER, and aspirin||mg/dL||95% Confidence Interval|Mean
719738|NCT00300430|Secondary|Median Percent Change in High-sensitivity C-reactive Protein (hsCRP) From Baseline to Week 52 of the Open-label Study||Baseline to Week 52 of the open-label study|Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies. Baseline is the last value before the first dose of combination therapy in the preceding studies. Percent changes from baseline to Week 52 in this open-label study are summarized. No imputations were made for missing values.||percent change||Full Range|Median
719739|NCT00300430|Primary|Percentage of Subjects Reporting Adverse Events During Combination Therapy, Either in the Preceding Double-blind Studies or in This Open-label Study||Anytime after initiation of combination therapy (either in the double-blind or open-label study) to within 30 days after the last dose of combination therapy|Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies or in this open-label study. All adverse events in the preceding studies or in this study occurring with exposure to combination therapy are summarized.||percentage of participants|||Number
719740|NCT00300430|Secondary|Mean Percent Change in Apolipoprotein B (Apo B) From Baseline to Week 52 of the Open-label Study||Baseline to Week 52 of the open-label study|Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies. Baseline is the last value before the first dose of combination therapy in the preceding studies. Percent changes from baseline to Week 52 in this open-label study are summarized. No imputations were made for missing values.||percent change||Standard Deviation|Mean
719741|NCT00300430|Secondary|Mean Percent Change in Total Cholesterol From Baseline to Week 52 of the Open-label Study||Baseline to Week 52 of the open-label study|Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies. Baseline is the last value before the first dose of combination therapy in the preceding studies. Percent changes from baseline to Week 52 in this open-label study are summarized. No imputations were made for missing values.||percent change||Standard Deviation|Mean
719742|NCT00300430|Secondary|Mean Percent Change in Very Low-density Lipoprotein Cholesterol (VLDL-C) From Baseline to Week 52 of the Open-label Study||Baseline to Week 52 of the open-label study|Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies. Baseline is the last value before the first dose of combination therapy in the preceding studies. Percent changes from baseline to Week 52 in this open-label study are summarized. No imputations were made for missing values.||percent change||Standard Deviation|Mean
719743|NCT00300430|Secondary|Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Week 52 in This Open-label Study||Baseline to Week 52 in this open-label study|Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies. Baseline is the last value before the first dose of combination therapy in the preceding studies. Percent changes from baseline to Week 52 in this open-label study are summarized. No imputations were made for missing values.||percent change||Standard Deviation|Mean
719744|NCT00300430|Secondary|Mean Percent Change in Direct Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 52 of the Open-label Study||Baseline to Week 52 of the open-label study|Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies. Baseline is the last value before the first dose of combination therapy in the preceding studies. Percent changes from baseline to Week 52 in this open-label study are summarized. No imputations were made for missing values.||percent change||Standard Deviation|Mean
719745|NCT00300430|Secondary|Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 52 of the Open-label Study||Baseline to Week 52 of the open-label study|Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies. Baseline is the last value before the first dose of combination therapy in the preceding studies. Percent changes from baseline to Week 52 in this open-label study are summarized. No imputations were made for missing values.||percent change||Standard Deviation|Mean
719746|NCT00300430|Secondary|Median Percent Change in Triglycerides From Baseline to Week 52 of the Open-label Study||Baseline to Week 52 of the open-label study|Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies. Baseline is the last value before the first dose of combination therapy in the preceding studies. Percent changes from baseline to Week 52 in this open-label study are summarized. No imputations were made for missing values.||percent change||Full Range|Median
719747|NCT00300456|Secondary|Median Percent Change in High-sensitivity C-reactive Protein (hsCRP) From Baseline to Final Visit|[(Week 12 hsCRP minus baseline hsCRP)/baseline hsCRP] x 100|Baseline to 12 Weeks (Final Visit)|All randomized subjects with a baseline hsCRP value and at least 1 postbaseline hsCRP value, LOCF||percent change||Inter-Quartile Range|Median
719748|NCT00300456|Secondary|Mean Percent Change in Lipoprotein Apo B (Apo B) From Baseline to Final Visit|[(Week 12 Apo B minus baseline Apo B)/baseline Apo B] x 100|Baseline to 12 Weeks (Final Visit)|All randomized subjects with a baseline ApoB value and at least 1 postbaseline ApoB value, LOCF||percent change||Standard Error|Mean
719749|NCT00300456|Secondary|Mean Percent Change in Total Cholesterol From Baseline to Final Visit|[(Week 12 total cholesterol minus baseline total cholesterol)/baseline total cholesterol] x 100|Baseline to 12 Weeks (Final Visit)|All randomized subjects with a baseline total cholesterol value and at least 1 postbaseline total cholesterol value, LOCF||percent change||Standard Error|Mean
719750|NCT00300456|Secondary|Mean Percent Change in Very Low-density Lipoprotein Cholesterol (VLDL-C)From Baseline to Final Visit|[(Week 12 VLDL-C minus baseline VLDL-C)/baseline VLDL-C] x 100|Baseline to 12 Weeks (Final Visit)|All randomized subjects with a baseline VLDL-C value and at least 1 postbaseline VLDL-C value, LOCF||percent change||Standard Error|Mean
719751|NCT00300456|Secondary|Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Final Visit|[(Week 12 non-HDL-C minus baseline non-HDL-C)/baseline non-HDL-C] x 100|Baseline to 12 Weeks (Final Visit)|All randomized subjects with a baseline non-HDL-C value and at least 1 postbaseline non-HDL-C value, LOCF||percent change||Standard Error|Mean
719752|NCT00300456|Primary|Mean Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Final Visit|[(Week 12 LDL-C minus baseline LDL-C)/baseline LDL-C] x 100|Baseline to 12 Weeks (Final Visit)|All randomized subjects with a baseline LDL-C value and at least 1 postbaseline LDL-C value, last observation carried forward||percent change||Standard Error|Mean
719753|NCT00300456|Primary|Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit|[(Week 12 HDL-C minus baseline HDL-C)/baseline HDL-C] x 100|Baseline to 12 Weeks (Final Visit)|All randomized subjects with a baseline HDL-C value and at least 1 postbaseline HDL-C value, last observation carried forward||percent change||Standard Error|Mean
719754|NCT00300456|Primary|Mean Percent Change in Triglycerides From Baseline to Final Visit|[(Week 12 triglycerides minus baseline triglycerides)/baseline triglycerides] x 100|Baseline to 12 Weeks (Final Visit)|All randomized subjects with a baseline triglyceride value and at least 1 postbaseline triglyceride value, last observation carried forward||percent change||Standard Error|Mean
719755|NCT00300469|Secondary|Median Percent Change in High-sensitivity C-reactive Protein (hsCRP) From Baseline to Final Visit|[(Week 12 hsCRP minus baseline hsCRP)/baseline hsCRP] x 100|Baseline to 12 Weeks (Final Visit)|All randomized subjects with a baseline hsCRP value and at least 1 postbaseline hsCRP value, LOCF||percent change||Inter-Quartile Range|Median
719756|NCT00300469|Secondary|Mean Percent Change in Lipoprotein Apo B (Apo B) From Baseline to Final Visit|[(Week 12 Apo B minus baseline Apo B)/baseline Apo B] x 100|Baseline to 12 Weeks (Final Visit)|All randomized subjects with a baseline ApoB value and at least 1 postbaseline ApoB value, LOCF||percent change||Standard Error|Mean
719757|NCT00300469|Secondary|Mean Percent Change in Total Cholesterol From Baseline to Final Visit|[(Week 12 total cholesterol minus baseline total cholesterol)/baseline total cholesterol] x 100|Baseline to 12 Weeks (Final Visit)|All randomized subjects with a baseline total cholesterol value and at least 1 postbaseline total cholesterol value, LOCF||percent change||Standard Error|Mean
719758|NCT00300469|Secondary|Mean Percent Change in Very Low-density Lipoprotein Cholesterol (VLDL-C) From Baseline to Final Visit|[(Week 12 VLDL-C minus baseline VLDL-C)/baseline VLDL-C] x 100|Baseline to 12 Weeks (Final Visit)|All randomized subjects with a baseline VLDL-C value and at least 1 postbaseline VLDL-C value, LOCF||percent change||Standard Error|Mean
719759|NCT00300469|Secondary|Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Final Visit|[(Week 12 non-HDL-C minus baseline non-HDL-C)/baseline non-HDL-C] x 100|Baseline to 12 Weeks (Final Visit)|All randomized subjects with a baseline non-HDL-C value and at least 1 postbaseline non-HDL-C value, LOCF||percent change||Standard Error|Mean
719760|NCT00300469|Primary|Mean Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Final Visit|[(Week 12 LDL-C minus baseline LDL-C)/baseline LDL-C] x 100|Baseline to 12 Weeks (Final Visit)|All randomized subjects with a baseline LDL-C value and at least 1 postbaseline LDL-C value, last observation carried forward (excluding 1 subject with extreme outlying value)||percent change||Standard Error|Mean
719761|NCT00300469|Primary|Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit|[(Week 12 HDL-C minus baseline HDL-C)/baseline HDL-C] x 100|Baseline to 12 Weeks (Final Visit)|All randomized subjects with a baseline HDL-C value and at least 1 postbasline HDL-C value, last observation carried forward (excluding 1 subject with extreme outlying value)||percent change||Standard Error|Mean
719762|NCT00300469|Primary|Mean Percent Change in Triglycerides From Baseline to Final Visit|[(Week 12 triglycerides minus baseline triglycerides)/baseline triglycerides] x 100|Baseline to 12 Weeks (Final Visit)|All randomized subjects with a baseline triglyceride value and at least 1 postbaseline triglyceride value, last observation carried forward (excluding one subject with an extreme outlying value)||percent change||Standard Error|Mean
719763|NCT00300482|Secondary|Median Percent Change in High-sensitivity C-reactive Protein (hsCRP) From Baseline to Final Visit|[(Week 12 hsCRP minus baseline hsCRP)/baseline hsCRP] x 100|Baseline to 12 Weeks|All randomized subjects with a baseline hsCRP value and at least 1 postbaseline hsCRP value, LOCF||percent change||Inter-Quartile Range|Median
719764|NCT00300482|Secondary|Mean Percent Change in Lipoprotein Apo B (Apo B) From Baseline to Final Visit|[(Week 12 Apo B minus baseline Apo B)/baseline Apo B] x 100|Baseline to 12 Weeks|All randomized subjects with a baseline ApoB and at least 1 postbaseline ApoB value, LOCF||percent change||Standard Error|Mean
719765|NCT00300482|Secondary|Mean Percent Change in Total Cholesterol From Baseline to Final Visit|[(Week 12 total cholesterol minus baseline total cholesterol)/baseline total cholesterol] x 100|Baseline to 12 Weeks|All randomized subjects with a baseline total cholesterol value and at least 1 postbaseline total cholesterol value, LOCF||percent change||Standard Error|Mean
719766|NCT00300482|Secondary|Mean Percent Change in Very Low-density Lipoprotein Cholesterol (VLDL-C) From Baseline to Final Visit|[(Week 12 VLDL-C minus baseline VLDL-C)/baseline VLDL-C] x 100|Baseline to 12 Weeks|All randomized subjects with a baseline VLDL-C value and at least 1 postbaseline VLDL-C value, LOCF||percent change||Standard Error|Mean
719767|NCT00300482|Secondary|Mean Percent Change in Non-low-density Lipoprotein Cholesterol (Non-HDL-C)From Baseline to Final Visit|[(Week 12 non-HDL-C minus baseline non-HDL-C)/baseline non-HDL-C] x 100|Baseline to 12 Weeks|All randomized subjects with a baseline non-HDL-C value and at least 1 postbaseline non-HDL-C value, LOCF||percent change||Standard Error|Mean
719768|NCT00300482|Primary|Mean Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Final Visit|[(Week 12 LDL-C minus baseline LDL-C)/baseline LDL-C] x 100|Baseline to 12 Weeks|All randomized subjects with a baseline LDL-C value and at least 1 postbaseline LDL-C value, last observation carried forward||percent change||Standard Error|Mean
719769|NCT00300482|Primary|Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit|[(Week 12 HDL-C minus baseline HDL-C)/baseline HDL-C] x 100|Baseline to 12 Weeks|All randomized subjects with a baseline HDL-C value and at least 1 postbaseline HDL-C value, last observation carried forward||percent change||Standard Error|Mean
719770|NCT00300482|Primary|Mean Percent Change in Triglycerides From Baseline to Final Visit|[(Week 12 triglycerides minus baseline triglycerides)/baseline triglycerides] x 100|Baseline to 12 Weeks|All randomized subjects with a baseline triglyceride value and at least 1 postbaseline triglyceride value, last observation carried forward||percent change||Standard Error|Mean
719771|NCT00300495|Secondary|Length of Post-operative Hospital Stay|Length of hospital stay after the operation|1 week on average|||Days||Standard Deviation|Mean
719772|NCT00300495|Primary|Incidence of Post-operative Atrial Fibrillation|Number of patients with post-operative atrial fibrillation|30 days|||Participants|||Count of Participants
719773|NCT00300677|Primary|Brain Concentrations of N-oxide Metabolite|Mean brain concentrations (ng/mL) of voriconazole N-oxide metabolite pre-dose and 2 hours post-dose measured by Fluorine (F) Magnetic Resonance Spectroscopy (F-MRS).|Day 3: pre-dose, 2 hours post-dose|Pharmacokinetic Analysis Set: subjects included in the statistical analysis of pharmacokinetic parameters had the pharmacokinetic parameter of interest. N=number of observations (non-missing concentrations).||ng/mL||Standard Deviation|Mean
719774|NCT00300677|Primary|Plasma Concentrations of N-oxide Metabolite|Mean plasma concentrations of voriconazole N-oxide metabolite (ng/mL) pre-dose and 2 hours post-dose. Plasma samples were assayed using a validated, sensitive, and specific high performance liquid chromatography/tandem mass spectrometry (HPLC-MS/MS) method.|Day 3: pre-dose, 2 hours post-dose|Pharmacokinetic Analysis Set: subjects included in the statistical analysis of pharmacokinetic parameters had the pharmacokinetic parameter of interest. N=number of observations (non-missing concentrations).||ng/mL||Standard Deviation|Mean
719775|NCT00300677|Primary|Brain Concentrations of Voriconazole|Mean brain concentrations (ng/mL) of voriconazole pre-dose and 2 hours post-dose measured by Fluorine (F) Magnetic Resonance Spectroscopy (F-MRS).|Day 3: pre-dose, 2 hours post-dose|Pharmacokinetic Analysis Set: subjects included in the statistical analysis of pharmacokinetic parameters had the pharmacokinetic parameter of interest. N=number of observations (non-missing concentrations).||ng/mL||Standard Deviation|Mean
721020|NCT00317941|Secondary|Mean Pain Assessment Using Visual Analogue Scale (VAS) Reported by Participants 24 Hours After Injection|Visual analogue scale was used to report the pain from 0 (no pain ) to 10 (maximal pain).|24h after injection|||Scores on a scale||Full Range|Mean
719776|NCT00300677|Primary|Plasma Concentrations of Voriconazole|Mean plasma voriconazole concentrations (nanograms per milliliter [ng/mL]) pre-dose (Cmin) and two hours post-dose (C2h). Plasma samples were assayed using a validated, sensitive, and specific high performance liquid chromatography/tandem mass spectrometry (HPLC-MS/MS) method.|Day 3: pre-dose, 2 hours post-dose|Pharmacokinetic Analysis Set: subjects included in the statistical analysis of pharmacokinetic parameters had the pharmacokinetic parameter of interest. N=number of observations (non-missing concentrations).||ng/mL||Standard Deviation|Mean
719777|NCT00291135|Primary|Change in Proliferation of Breast Epithelial Cells Obtained by Random Periareolar Fine Needle Aspiration.|Proliferation assessment by immunocytochemistry using Ki-67. Expressed as percent of cells staining positive for Ki-67.|Baseline, 6 months|All subjects completed study and were used for analysis||Change in % of cells positive for Ki-67||Full Range|Median
719778|NCT00291161|Primary|Veteran Outcomes|The following outcomes were measured for veterans via scales administered to each veteran: Unmet need (range=0 to 24, higher meaning more unmet needs); Embarrassment about memory problems (range=0-3, higher indicating greater embarrassment); Isolation (range=0-4, higher indicating greater isolation); Relationship strain (range=0-4, higher indicating greater relationship strain); Depression (range=0-11, higher indicating greater depression).|Baseline - six months|Data were collected for veterans who could be interviewed only.||units on a scale||Standard Deviation|Mean
719779|NCT00291161|Primary|Caregiver Outcomes|The following outcomes were measured in Caregivers via scales administered to each caregiver: Unmet need (range=0 to 39, higher meaning more unmet needs); Role captivity (range=0-9, higher indicating greater role captivity); Physical health strain (range=0-9, higher indicating greater health strain); Relationship strain (range=0-18, higher indicating greater relationship strain); Depression (range=0-22, higher indicating greater depression); Caregiver support service use (the number of support services utilized, 0-2); Number of informal helpers (range=0-50, higher indicating more informal helpers)|Baseline and at six months|Data were collected for caregivers only||units on a scale||Standard Deviation|Mean
719780|NCT00291187|Post-Hoc|Average Improvement in Latency to Non-awake (LNA)|The average improvement in latency to non-awake (length of time elapsed between lights off and first epoch of sleep determined by PSG) is defined as the difference observed in the VEC-162 treated subjects compared with placebo treated subjects.|Night 1|Modified ITT defined as any subject randomized into the study who received a dose of study drug and had PSG data. For the purposes of this trial, a subject was considered to have PSG data if 50% or more of the full night PSG was scored.||Minutes||Standard Error|Mean
719781|NCT00291187|Post-Hoc|Average Improvement in Total Sleep Time (TST)|The average improvement in Total sleep time (determined by PSG and defined as the number of non-wake minutes between lights off and lights on) is defined as the difference observed in the VEC-162 treated subjects compared with placebo treated subjects.|Night 1|Modified ITT defined as any subject randomized into the study who received a dose of study drug and had PSG data. For the purposes of this trial, a subject was considered to have PSG data if 50% or more of the full night PSG was scored.||Minutes||Standard Error|Mean
719782|NCT00291187|Secondary|Average Improvement of Wake After Sleep Onset (WASO)|The average improvement of wake after sleep onset (time spent awake between onset of sleep and lights on, determined by PSG) is defined as the difference observed in the VEC-162 treated subjects compared with placebo treated subjects.|Night 1|Modified ITT defined as any subject randomized into the study who received a dose of study drug and had PSG data. For the purposes of this trial, a subject was considered to have PSG data if 50% or more of the full night PSG was scored.||minutes||Standard Error|Mean
719783|NCT00291187|Primary|Average Improvement of Latency to Persistent Sleep (LPS)|The average improvement in Latency to persistent sleep (the number of minutes between Lights Off and the onset of at least 10 minutes of persistent sleep, as measured by polysomnography) is defined as the difference observed in the VEC-162 treated subjects compared with placebo treated subjects.|Night 1|Modified ITT defined as any subject randomized into the study who received a dose of study drug and had PSG data. For the purposes of this trial, a subject was considered to have PSG data if 50% or more of the full night PSG was scored.||minutes||Standard Error|Mean
719784|NCT00291226|Primary|Change in Scale of Prodromal Symptoms Total Score|Scale Of Prodromal Symptoms (SOPS) is a 19-item instrument. The SOPS is comprised of symptoms that are classified as falling into four pathology domains: positive, negative, disorganized and general. The scales identify and measure five attenuated positive psychotic symptoms, six negative symptoms, four disorganization symptoms and four general symptoms. These seven-point scales cover severity variance in the subpsychotic or attenuated range. Each item is scaled 0–6, with 0–2 being the normal range, 3–5 being the risk syndrome range, and 6 being severe and psychotic for the positive symptoms and very severe for the other symptoms. The higher the score, the more symptoms an individual has and is therefore negative in its interpretation. The severity of the prodromal state is judged according to the sum of the ratings from each of the SOPS items and can range from 0 to 114. Actual SOPS total scores in this study ranged from 23 to 59 across subjects at baseline.|Change from Baseline at 8 Weeks|||units on a scale||Standard Deviation|Mean
719785|NCT00291226|Primary|Scale of Prodromal Symptoms Total Score|Scale Of Prodromal Symptoms (SOPS) is a 19-item instrument. The SOPS is comprised of symptoms that are classified as falling into four pathology domains: positive, negative, disorganized and general. The scales identify and measure five attenuated positive psychotic symptoms, six negative symptoms, four disorganization symptoms and four general symptoms. These seven-point scales cover severity variance in the subpsychotic or attenuated range. Each item is scaled 0–6, with 0–2 being the normal range, 3–5 being the risk syndrome range, and 6 being severe and psychotic for the positive symptoms and very severe for the other symptoms. The higher the score, the more symptoms an individual has and is therefore negative in its interpretation. The severity of the prodromal state is judged according to the sum of the ratings from each of the SOPS items and can range from 0 to 114. Actual SOPS total scores in this study ranged from 23 to 59 across subjects at baseline.|Baseline|||units on a scale||Standard Deviation|Mean
719805|NCT00291343|Secondary|Number of Subjects With Anti-pilysaccharide A and C (Anti-PSA/PSC) Antibody Concentrations ≥ Predefined Cut-off Values|Antibody cut-offs were ≥ 0.3, 2 micrograms per millilitre (µg/mL).|Prior to (at 24 to 30 months of age) and after (at 25 to 31 months of age) Mencevax™ ACWY vaccination.|The analysis were performed on the Booster ATP cohort for immunogenicity which included all subjects who had received 3 doses in the primary vaccination study, who had received a single dose of MenACWY according to protocol at 24 to 30 months of age and for whom data concerning immunogenicity measures were available.||Subjects|||Number
719786|NCT00291317|Primary|Change in Bone Mineral Density Measured Via DEXA Scan|Bone mineral density (BMD) was measured with Dual X-ray Absorptiometry (DEXA) scans using a GE LUNAR system. DEXA has been used in patients with loss of ambulation due to SCI to monitor changes in body composition over time and to evaluate the effectiveness of exercise in preventing or reducing the disease-related complications of SCI. It was used in the present study to determine BMD in the right distal femur at baseline; after 3 months of intervention; after 6 months; and for children who biked for the full duration of the study, at the completion of 9 months of intervention.|At entry until completion (range 4-14 months) (One participant's DEXA scan was obtained late due to illness)|||g/cm^2||Standard Deviation|Mean
719787|NCT00291317|Primary|Change in Pediatric Quality of Life Inventory Version 4.0 (PedsQL 4.0)Score.|The PedsQL™ 4.0 is a modular instrument for measuring health-related quality of life in children and adolescents. The questionnaire asks how much of a problem each item has been during the past month, using a 5-point response scale. This study used the Emotional Functioning, Social Functioning, and School Functioning modules. Scores on these three modules are combined to yield a Psychosocial Health Summary Score (range = 0-100 with 100 being the maximum positive outcome). Pre- and post-intervention scores were compared to determine improvement.|pre- and post-intervention; time frame among participants ranged from 4 to 12 months|Four of the six participants completed the PedsQL on at least 2 occasions. At minimum, each completed the PedsQL at their initial evaluation before beginning the cycling program and at or following their last cycling session.||units on a scale||Standard Deviation|Mean
719788|NCT00291330|Secondary|Laboratory Analyses|Frequency of patients with possible clinically significant abnormalities.|From first intake of study drug to last intake of study drug + 6 days washout (washout time can be reduced until 0 day if the patient takes an other anti−coagulant therapy on and after last intake of active study drug)|Treated set (TS): consisted of all randomised patients who were documented to have taken at least one dose of study drug. Patients were assigned to the treatment groups as treated.||participants|||Number
719789|NCT00291330|Secondary|Number of Participants With Acute Coronary Syndrome (ACS)|"Any ACS occurring during the conduct of the study (centrally adjudicated as definite).
Counts of patients having a centrally adjudicated definite ACS during intake of active study drug, after stopping active study drug and before or without intake of active study drug, according to treatment group.
All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee."|From first intake of study drug to end of study conduct|Treated set (TS): consisted of all randomised patients who were documented to have taken at least one dose of study drug. Patients were assigned to the treatment groups as treated.||participants|||Number
719790|NCT00291330|Secondary|Number of Participants With Bleeding Events|"Major bleeding events (MBE) were defined as
Fatal bleeding
Symptomatic bleeding in a critical area or organ
Bleeding causing a fall in haemoglobin level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of 2 or more units of whole blood or red cells
Clinically-relevant bleeding events (CRBE) was defined as
spontaneous skin hematoma >=25 cm²
spontaneous nose bleed >5 min
macroscopic hematuria spontaneous or >24 hours if associated with an intervention
spontaneous rectal bleeding (more than spotting on toilet paper)
gingival bleeding >5 min
leading to hospitalisation and / or requiring surgical treatment
leading to a transfusion of <2 units of whole blood or red cells
any other bleeding event considered clinically relevant by the investigator
Any bleeding events were defined as major, clinically-relevant and nuisance bleeding events. Nuisance bleeding events were defined as all other bleeding events that did not fulfil the criteria from above."|From first intake of study drug to last intake of study drug + 6 days washout (washout time can be reduced until 0 day if the patient takes an other anti−coagulant therapy on and after last intake of active study drug)|Treated set (TS): consisted of all randomised patients who were documented to have taken at least one dose of study drug. Patients were assigned to the treatment groups as treated.||participants|||Number
719791|NCT00291330|Secondary|Number of Participants Who Died (Any Cause)|Any deaths which occured from randomisation to end of post treatment period. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.|For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.|Full analysis set (FAS): consisted of all randomised patients who were documented to have taken at least one dose of study drug. Patients were assigned to the treatment groups as randomised, i.e. regardless of the actual medication taken.||participants|||Number
719792|NCT00291330|Secondary|Number of Participants Who Died Due to VTE|"VTE - related deaths which occured from randomisation to end of post treatment period.
All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee."|For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.|Full analysis set (FAS): consisted of all randomised patients who were documented to have taken at least one dose of study drug. Patients were assigned to the treatment groups as randomised, i.e. regardless of the actual medication taken.||participants|||Number
719793|NCT00291330|Secondary|Number of Participants With Recurrent Symptomatic Non-fatal PE|"Symptomatic non-fatal PE which occured from randomisation to end of post treatment period.
All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee."|For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.|Full analysis set (FAS): consisted of all randomised patients who were documented to have taken at least one dose of study drug. Patients were assigned to the treatment groups as randomised, i.e. regardless of the actual medication taken.||participants|||Number
719806|NCT00291343|Secondary|Anti-rSBA-MenA, C Antibody Titers|Antibody titers were expressed as Geometric Mean Titers (GMTs)|Prior to (at 24 to 30 months of age) and after (at 25 to 31 months of age) Mencevax™ ACWY vaccination.|The analysis were performed on the Booster ATP cohort for immunogenicity which included all subjects who had received 3 doses in the primary vaccination study, who had received a single dose of MenACWY according to protocol at 24 to 30 months of age and for whom data concerning immunogenicity measures were available.||Titers||95% Confidence Interval|Geometric Mean
719794|NCT00291330|Secondary|Number of Participants With Recurrent Symptomatic DVT|"Symptomatic DVT which occured from randomisation to end of post treatment period.
All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee."|For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.|Full analysis set (FAS): consisted of all randomised patients who were documented to have taken at least one dose of study drug. Patients were assigned to the treatment groups as randomised, i.e. regardless of the actual medication taken.||participants|||Number
719795|NCT00291330|Secondary|Number of Participants With Recurrent Symptomatic VTE and All Deaths|"VTE or any death which occured from randomisation to end of post treatment period.
All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee."|For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.|Full analysis set (FAS): consisted of all randomised patients who were documented to have taken at least one dose of study drug. Patients were assigned to the treatment groups as randomised, i.e. regardless of the actual medication taken.||Participants|||Number
719796|NCT00291330|Primary|Number of Participants With Recurrent Symptomatic Venous Thromboembolism (VTE) and Deaths Related to VTE|All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.|For statistical analysis 1: from randomisation to end of post treatment period (ptp), planned to be up to day 224. For statistical analysis 2: from randomisation to 6 months (up to day 180)|Full analysis set (FAS): consisted of all randomised patients who were documented to have taken at least one dose of study drug. Patients were assigned to the treatment groups as randomised, i.e. regardless of the actual medication taken.||Participants|||Number
719797|NCT00291343|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From 15-24 Months of age up to Months 25-31 of age|The analysis were performed on the Booster Total Vaccinated Cohort included all subjects vaccinated during study NCT00291343.||Subjects|||Number
719798|NCT00291343|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regard-less of intensity grade or relation to vaccination.|From Day 0 at months 15-24 of age to study end at Months 25-31 of age|The analysis were performed on the Booster Total Vaccinated Cohort included all subjects vaccinated during study NCT00291343.||Subjects|||Number
719799|NCT00291343|Secondary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite, rectal fever [≥ 38 degrees Celsius (°C)]. Any = occurrence of symptom regardless of intensity grade.|During the 4-day follow-up period after the Mencevax™ ACWY vaccination, at 24-30 months of age|The analysis were performed on the Booster Total Vaccinated Cohort included all subjects vaccinated during study NCT00291343.||Subjects|||Number
719800|NCT00291343|Secondary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness, swelling. Any = symptom occurring regardless of intensity grade.|During the 4-day follow-up period after the Mencevax™ ACWY vaccination, at 24-30 months of age|The analysis were performed on the Booster Total Vaccinated Cohort included all subjects vaccinated during study NCT00291343.||Subjects|||Number
719801|NCT00291343|Secondary|Number of Subjects With Vaccine Response for rSBA-Men A, C|Vaccine response was defined as follows: for initially seronegative subjects (i.e. with rSBA titer < 1:8 pre-vaccination), rSBA titer ≥ 1:32 post-vaccination (seroconversion), and for initially seropositive subjects (i.e. with rSBA > 1:8 prevaccination), at least a 4-fold increase in rSBA titer from pre-vaccination to post-vaccination.|1 month after Mencevax™ ACWY vaccination (at 25 to 31 months of age).|The analysis were performed on the Booster ATP cohort for immunogenicity which included all subjects who had received 3 doses in the primary vaccination study, who had received a single dose of MenACWY according to protocol at 24 to 30 months of age and for whom data concerning immunogenicity measures were available.||Subjects|||Number
719802|NCT00291343|Secondary|Anti-HBs Concentrations|Antibody concnetrations were expressed as Geometric Mean Concentrations (GMCs).|Prior to the Mencevax™ ACWY vaccination at 24-30 Months of age|The analysis were performed on the Booster ATP cohort for immunogenicity which included all subjects who had received 3 doses in the primary vaccination study, who had received a single dose of MenACWY according to protocol at 24 to 30 months of age and for whom data concerning immunogenicity measures were available.||mIU/mL||95% Confidence Interval|Geometric Mean
719803|NCT00291343|Secondary|Number of Subjects With Anti-hepatitis B Surface (Anti-HBs) Antigen Antibody Concentrations ≥ Cut-offs|The antibody concentrations cut-off was ≥ 10 milli international units per millilitre (mIU/mL).|Prior to the Mencevax™ ACWY vaccination at 24-30 Months of age|The analysis were performed on the Booster ATP cohort for immunogenicity which included all subjects who had received 3 doses in the primary vaccination study, who had received a single dose of MenACWY according to protocol at 24 to 30 months of age and for whom data concerning immunogenicity measures were available.||Subjects|||Number
719804|NCT00291343|Secondary|Anti-PSA, Anti-PSC Antibody Concentrations|Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs).|Prior to (at 24 to 30 months of age) and after (at 25 to 31 months of age) Mencevax™ ACWY vaccination.|The analysis were performed on the Booster ATP cohort for immunogenicity which included all subjects who had received 3 doses in the primary vaccination study, who had received a single dose of MenACWY according to protocol at 24 to 30 months of age and for whom data concerning immunogenicity measures were available.||µg/mL||95% Confidence Interval|Geometric Mean
719897|NCT00293059|Secondary|Change From Baseline in Hemoglobin Concentration at Treatment Day 84|Hemoglobin was measured before treatment and after 84 days under treatment. A positive value indicates an increase in hemoglobin from baseline at treatment day 84.|baseline and treatment day 84|ITT, excluding participants with missing data||g/dL||Standard Deviation|Mean
719807|NCT00291343|Secondary|Number of Subjects With Anti-rSBA-MenA, C Antibody Titers ≥ Pre-defined Cut-off Values|Pre-defined cut-offs were ≥ 1:8 and ≥ 1:128|Prior to (at 24 to 30 months of age) and after (at 25 to 31 months of age) Mencevax™ ACWY vaccination.|The analysis were performed on the Booster ATP cohort for immunogenicity which included all subjects who had received 3 doses in the primary vaccination study, who had received a single dose of MenACWY according to protocol at 24 to 30 months of age and for whom data concerning immunogenicity measures were available.||Subjects|||Number
719808|NCT00291343|Primary|Number of Subjects With Serum Bactericidal Activity Against Neisseria Meningitidis Serogroups A, C (rSBA-MenA, C) Using Rabbit Complement Antibodies|Antibody cut-offs were higher than or equal to (≥) 1:128|1 month after Mencevax™ ACWY vaccination (at 25 to 31 months of age).|The analyses were performed on the Booster ATP cohort for immunogenicity which included all subjects who had received 3 doses in the primary vaccination study, who had received a single dose of MenACWY according to protocol at 24 to 30 months of age and for whom data concerning immunogenicity measures were available.||Subjects|||Number
719809|NCT00292162|Secondary|Plasma B-type Natriuretic Peptide (BNP) at 6 Months|Plasma B-type Natriuretic Peptide (BNP)|6 months|||picograms per millilitre||Standard Deviation|Mean
719810|NCT00292162|Secondary|Plasma B-type Natriuretic Peptide (BNP) at Baseline|Plasma B-type Natriuretic Peptide (BNP) measured at basline|Baseline|||picograms per millilitre||Standard Deviation|Mean
719811|NCT00292162|Primary|Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)at 6 Months|Left Ventricular Ejection Fraction as measured by Magnetic Resonance Imaging (MRI)at 6 months|6 months|||percentage of blood ejected in one beat||Standard Deviation|Mean
719812|NCT00292162|Primary|Baseline Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)|Baseline Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)in %|Baseline|Number of patients analyzed is different from number of patients enrolled because some of the outcomes could not be measured in some patients ie the patient did not tolerate an mri or dropped out of the study||percentage of blood ejected in one beat||Standard Deviation|Mean
719813|NCT00292162|Secondary|Plasma B-type Natriuretic Peptide (BNP)|venous blood taken to assess levels of the above peptide. High evels of the peptide are associated with adverse prognosis. Blood levels are taken at baseline and 6 months. The change over 6 months is assessed, thereore it is possible to have a negative number if the level falls.|baseline and 6 months|Number of patients analyzed is different from number of patients enrolled because some of the outcomes could not be measured in some patients ie the patient did not tolerate a blood test or dropped out of the study||picograms per millilitre||Standard Deviation|Mean
719814|NCT00292162|Primary|Change in Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)%|left ventricular ejection fraction (LVEF) is a measure of the % of blood ejected from the ventricle in one heart beat. It is a measure of cardiac function. We measured LVEF at baseline and at 6 months, to assess whether there had been a change in the patients cardiac function over time.|baseline and 6 months|Number of patients analyzed is different from number of patients enrolled because some of the outcomes could not be measured in some patients ie the patient did not tolerate an mri or dropped out of the study||percentage of blood ejected in one beat||Standard Deviation|Mean
719815|NCT00292188|Secondary|Davidson Trauma Scale (DTS): Total Score|Self-rated instrument to measure symptom severity and treatment outcome in post traumatic stress disorder (PTSD). Scale of 17 PTSD symptoms over previous week; frequency scale: 0 (not at all) to 4 (every day), and severity 0 (not at all distressing) to 4(extremely distressing). The total Davidson Trauma Scale score ranges from 0 to 136.|Baseline, Week 8|FAS, LOCF. Number of subjects with evaluable data: (n=pregabalin, placebo), respectively.||score on scale||Standard Deviation|Mean
719816|NCT00292188|Secondary|Davidson Trauma Scale (DTS): Frequency|Self-rated instrument to measure symptom severity and treatment outcome in post traumatic stress disorder (PTSD). Scale of 17 PTSD symptoms over previous week; frequency scale: 0 (not at all) to 4 (every day), and severity 0 (not at all distressing) to 4(extremely distressing). The total Davidson Trauma Scale score ranges from 0 to 136.|Baseline, Week 8|FAS, LOCF. Number of subjects with evaluable data: (n=pregabalin, placebo), respectively.||score on scale||Standard Deviation|Mean
719817|NCT00292188|Secondary|Davidson Trauma Scale (DTS): Severity|Self-rated instrument to measure symptom severity and treatment outcome in post traumatic stress disorder (PTSD). Scale of 17 PTSD symptoms over previous week; frequency scale: 0 (not at all) to 4 (every day), and severity 0 (not at all distressing) to 4(extremely distressing). The total Davidson Trauma Scale score ranges from 0 to 136.|Baseline, Week 8|FAS, LOCF. Number of subjects with evaluable data: (n=pregabalin, placebo), respectively.||score on a scale||Standard Deviation|Mean
719818|NCT00292188|Secondary|Medical Outcome Study Cognitive Subscale (MOS-Cog); Thinking|The number of subjects' responses to each of the 6 questions on the Medical Outcome Study Cognitive (MOS-Cog) subscale were summarized at baseline and Week 8. Category range: all of the time to none of the time. No formal statistical modeling was used.|Baseline, Week 8|FAS, LOCF. The number of subjects that answered the question at Week 8 is 120, 121 for pregabalin, placebo respectively.||participants|||Number
719819|NCT00292188|Secondary|Medical Outcome Study Cognitive Subscale (MOS-Cog); Attention|The number of subjects' responses to each of the 6 questions on the Medical Outcome Study Cognitive (MOS-Cog) subscale were summarized at baseline and Week 8. Category range: all of the time to none of the time. No formal statistical modeling was used.|Baseline, Week 8|FAS, LOCF. The number of subjects that answered the question at Week 8 is 120, 121 for pregabalin, placebo respectively.||participants|||Number
719820|NCT00292188|Secondary|Medical Outcome Study Cognitive Subscale (MOS-Cog); Memory|The number of subjects' responses to each of the 6 questions on the Medical Outcome Study Cognitive (MOS-Cog) subscale were summarized at baseline and Week 8. Category range: all of the time to none of the time. No formal statistical modeling was used.|Baseline, Week 8|FAS, LOCF. The number of subjects that answered the question at Week 8 is 120, 121 for pregabalin, placebo respectively.||participants|||Number
719821|NCT00292188|Secondary|Medical Outcome Study Cognitive Subscale (MOS-Cog); Confusion|The number of subjects' responses to each of the 6 questions on the Medical Outcome Study Cognitive (MOS-Cog) subscale were summarized at baseline and Week 8. Category range: all of the time to none of the time. No formal statistical modeling was used.|Baseline, Week 8|FAS, LOCF. The number of subjects that answered the question at Week 8 is 119, 121 for pregabalin, placebo respectively.||particpants|||Number
719822|NCT00292188|Secondary|Medical Outcome Study Cognitive Subscale (MOS-Cog); Concentration|The number of subjects' responses to each of the 6 questions on the Medical Outcome Study Cognitive (MOS-Cog) subscale were summarized at baseline and Week 8. Category range: all of the time to none of the time. No formal statistical modeling was used.|Baseline, Week 8|FAS, LOCF. The number of subjects that answered the question at Week 8 is 120, 121 for pregabalin, placebo respectively.||participants|||Number
719823|NCT00292188|Secondary|Medical Outcome Study Cognitive Subscale (MOS-Cog); Reasoning|The number of subjects' responses to each of the 6 questions on the Medical Outcome Study Cognitive (MOS-Cog) subscale were summarized at baseline and Week 8. Category range: all of the time to none of the time. No formal statistical modeling was used.|Baseline, Week 8|FAS, LOCF. The number of subjects that answered the question at Week 8 is 120, 121 for pregabalin, placebo respectively.||participants|||Number
719824|NCT00292188|Secondary|Neuropathic Pain Symptom Inventory (NPSI) Total Intensity Score|Neuropathic Pain Symptom Inventory (NPSI) includes 10 descriptors (scale 0-10) of different pain symptoms & 2 temporal items assessing the duration of spontaneous ongoing and paroxysmal pain. A total intensity score is calculated by sub grouping the questions into five pain dimensions, summing the five sub groups, and converting into a percentage.|Week 8|FAS. Number of subjects with a non-missing NPSI Total Intensity Score at Baseline and Week 8 (using LOCF) is 100, 106 for pregabalin, placebo respectively.||percentage score on scale||Standard Error|Least Squares Mean
719825|NCT00292188|Secondary|Modified Brief Pain Inventory Short Form (m-BPI-sf)|Modified Brief Pain Inventory Short Form (m-BPI-sf): self-administered questionnaire to assess severity of pain (measured by 4 items)and impact of pain on daily functions (measured by 7 items)in past 24 hours. Items are rated on an 11-point scale ranging from 0 to 10, with higher scores indicating greater pain and/or interference due to pain.|Baseline, Week 8|Baseline; FAS, LOCF. Number of subjects with evaluable data: (n = pregabalin, placebo), respectively.||score on a scale||Standard Deviation|Mean
719826|NCT00292188|Secondary|Pain Treatment Satisfaction Scale (PTSS): Efficacy|Pain Treatment Satisfaction Scale (PTSS); Efficacy: measure of patient satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment.|Screening, Week 8|FAS, LOCF. Number of subjects with evaluable data (n=pregabalin, placebo), respectively.||score on scale||Standard Deviation|Mean
719827|NCT00292188|Secondary|Pain Treatment Satisfaction Scale (PTSS): Medication Characteristics|Pain Treatment Satisfaction Scale (PTSS); Medication Characteristics: measure of patient satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment.|Screening, Week 8|FAS, LOCF. Number of subjects with evaluable data (n=pregabalin, placebo), respectively.||score on scale||Standard Deviation|Mean
719828|NCT00292188|Secondary|Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication|Pain Treatment Satisfaction Scale (PTSS); Satisfaction with Current Pain Medication: measure of patient satisfaction with treatment for acute or chronic pain. Response range:1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment.|Screening, Week 8|FAS, LOCF. Number of subjects with evaluable data (n=pregabalin, placebo), respectively.||score on scale||Standard Deviation|Mean
719829|NCT00292188|Secondary|Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication|Pain Treatment Satisfaction Scale (PTSS); Impact of Current Pain Medication: measure of patient satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment.|Screening, Week 8|FAS, LOCF. Number of subjects with evaluable data (n=pregabalin, placebo), respectively.||score on a scale||Standard Deviation|Mean
719830|NCT00292188|Secondary|Clinical Global Impression of Change (CGIC)|Clinical Global Impression of Change (CGIC): clinician’s judgment of overall change in the patient’s condition over a defined period on a 7-point scale; range: 1 Very Much Improved to 7 Very Much Worse.|Week 8|FAS, LOCF||participants|||Number
719831|NCT00292188|Secondary|Patient Global Impression of Change (PGIC)|Patient Global Impression of Change (PGIC): a patient-rated instrument that measures change in patient’s overall status on a 7-point scale; range: 1 Very Much Improved to 7 Very Much Worse.|Week 8|FAS, LOCF||participants|||Number
719832|NCT00292188|Secondary|Medical Outcome Study (MOS) Optimal Sleep|Number of subjects responding to have had optimal sleep. Optimal sleep is 1 item in the Medical Outcome Study (MOS)sleep scale, a patient-reported measure consisting of twelve items that assess the key constructs of sleep. Subjects were asked to recall sleep-related activities over the past week.|Week 8|FAS, LOCF.||participants|||Number
719833|NCT00292188|Secondary|Medical Outcome Study (MOS) Sleep Subscales|Medical Outcome Study (MOS) is a patient-rated questionnaire consisting of 12 items that assess key constructs of sleep (7 subscales as well as a 9-item overall sleep problems index. MOS-Sleep Scale is scored from 0 to 100. A higher score indicates more disturbance.|Week 8|FAS, LOCF. Number of subjects with evaluable data (n = pregabalin, placebo), respectively.||score on a scale||Standard Error|Least Squares Mean
719834|NCT00292188|Secondary|Weekly Mean Sleep Interference Score|11-point numerical scale with which the patient describes pain interference with sleep over past 24 hours; range: 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep). Endpoint weekly mean score: mean of last 7 available scores from daily sleep interference diary during double-blind treatment.|Week 8|FAS, LOCF||score on scale||Standard Error|Least Squares Mean
719835|NCT00292188|Secondary|Number of Subjects With 30% and 50% Response in Weekly Mean Daily Pain Rating Score (DPRS) From Baseline Until Endpoint (Week 8)|Based on weekly mean daily pain rating score (DPRS), responders were defined as subjects with a >= 30% and >=50% reduction in weekly mean scores from baseline until endpoint (Week 8). Endpoint was calculated as the mean of the last 7 available pain scores from the daily pain diary while in the double-blind treatment phase.|Baseline, Week 8|FAS, LOCF.||participants|||Number
719836|NCT00292188|Secondary|Weekly Mean Pain Score From Daily Pain Diary|Daily Pain Diary scale : mean score from 11-point numerical scale of pain; range:0 (no pain) to 10 (worst possible pain). Mean of scores available for each week.|Baseline through Week 8|FAS. Number of subjects with evaluable data: (n = pregabalin, placebo), respectively||score on scale||Standard Error|Least Squares Mean
719837|NCT00292188|Secondary|Hospital Anxiety and Depression Scale (HADS) Depression Score - FAS Subset With Moderate/Severe Baseline Scores|Hospital Anxiety and Depression Scale (HADS-D) consists of 7 items that are assessed by a score of 0 = no depression to 3 = severe feeling of depression. The depression subscale focuses on the state of lost interest and diminished pleasure response (lowering of hedonic tone). Score range = 0 to 21; higher scores indicate a greater intensity of depression|Week 8|Subset of subjects from the FAS who had moderate/severe baseline depression scores. LOCF.||score on scale||Standard Error|Least Squares Mean
719838|NCT00292188|Secondary|Hospital Anxiety and Depression Scale (HADS) Anxiety Score - FAS Subset With Moderate/Severe Baseline Scores|Hospital Anxiety and Depression Scale Anxiety Score (HADS-A) consists of 7 items that are assessed by a score of 0 = no anxiety to 3 = severe feeling of anxiety. The anxiety subscale determines a state of generalized anxiety (including anxious mood, restlessness, anxious thoughts, panic attacks). Score range = 0 to 21; higher scores indicate a greater intensity of anxiety.|Week 8|Subset of subjects from the FAS who had moderate/severe baseline anxiety scores. LOCF.||score on scale||Standard Error|Least Squares Mean
719839|NCT00292188|Secondary|Hospital Anxiety and Depression Scale (HADS) Depression Score|Hospital Anxiety and Depression Scale Depression Score (HADS-D) consists of 7 items that are assessed by a score of 0 = no depression to 3 = severe feeling of depression. The depression subscale focuses on the state of lost interest and diminished pleasure response (“lowering of hedonic tone”). Score range = 0 to 21; higher scores indicate a greater intensity of depression|Week 8|FAS LOCF||score on scale||Standard Error|Least Squares Mean
719840|NCT00292188|Secondary|Hospital Anxiety and Depression Scale (HADS) Anxiety Score|Hospital Anxiety and Depression Scale Anxiety Score (HADS-A) consists of 7 items that are assessed by a score of 0 = no anxiety to 3 = severe feeling of anxiety. The anxiety subscale determines a state of generalized anxiety (including anxious mood, restlessness, anxious thoughts, panic attacks). Score range = 0 to 21; higher scores indicate a greater intensity of anxiety|Week 8|Full analysis set (FAS), last observation carried forward (LOCF)||score on scale||Standard Error|Least Squares Mean
719841|NCT00292188|Primary|Weekly Mean Pain Score at End of Treatment (Week 8) From Daily Pain Diary|Daily Pain Diary scale : mean score from 11-point numerical scale of pain; range: 0 (no pain) to 10 (worst possible pain). Endpoint weekly mean pain score: mean of the last 7 available pain scores from a daily pain diary during double blind treatment.|each day of Week 8|Full Analysis Set (FAS): all randomized subjects who received >= 1 dose study drug & have post-randomization efficacy data. Last Observation Carried Forward (LOCF).||score on a scale||Standard Error|Least Squares Mean
719842|NCT00292227|Secondary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 10 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)|Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 20:00h.|Baseline (Day -2/ Day -1) 20:00h, Day 32/ Day 39 20:00h|Safety population within the placebo patch group; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
719843|NCT00292227|Secondary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 9 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)|Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 19:00h.|Baseline (Day -2/ Day -1) 19:00h, Day 32/ Day 39 19:00h|Safety population within the placebo patch group; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
719844|NCT00292227|Secondary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 8 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)|Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 18:00h.|Baseline (Day -2/ Day -1) 18:00h, Day 32/ Day 39 18:00h|Safety population within the placebo patch group; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
719845|NCT00292227|Secondary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 7 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)|Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 17:00h.|Baseline (Day -2/ Day -1) 17:00h, Day 32/ Day 39 17:00h|Safety population within the placebo patch group; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
719846|NCT00292227|Secondary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 6 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)|Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 16:00h.|Baseline (Day -2/ Day -1) 16:00h, Day 32/ Day 39 16:00h|Safety population within the placebo patch group; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
719847|NCT00292227|Secondary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 5 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)|Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 15:00h.|Baseline (Day -2/ Day -1) 15:00h, Day 32/ Day 39 15:00h|Safety population within the placebo patch group; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
719848|NCT00292227|Secondary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 4 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)|Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 14:00h.|Baseline (Day -2/ Day -1) 14:00h, Day 32/ Day 39 14:00h|Safety population within the placebo patch group; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
719849|NCT00292227|Secondary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 3 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)|Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 13:00h.|Baseline (Day -2/ Day -1) 13:00h, Day 32/ Day 39 13:00h|Safety population within the placebo patch group; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
719850|NCT00292227|Secondary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 2 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)|Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 12:00h.|Baseline (Day -2/ Day -1) 12:00h, Day 32/ Day 39 12:00h|Safety population within the placebo patch group; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
719851|NCT00292227|Secondary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 1 Hour After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)|Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 11:00h.|Baseline (Day -2/ Day -1) 11:00h, Day 32/ Day 39 11:00h|Safety population within the placebo patch group; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
719852|NCT00292227|Secondary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI at Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)|Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 10:00h.|Baseline (Day -2/ Day -1) 10:00h, Day 32/ Day 39 10:00h|Safety population within the placebo patch group; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
719853|NCT00292227|Secondary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 1 Hour Before Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)|Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 9:00h.|Baseline (Day -2/ Day -1) 9:00h, Day 32/ Day 39 9:00h|Safety population within the placebo patch group; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
719854|NCT00292227|Secondary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 2 Hours Before Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)|Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 8:00h.|Baseline (Day -2/ Day -1) 8:00h, Day 32/ Day 39 8:00h|Safety population within the placebo patch group; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
719898|NCT00293059|Secondary|Change From Baseline in Serum Ferritin Concentration at Treatment Day 196|Serum ferritin was measured before treatment and after 196 days under treatment. A positive value indicates an increase in serum ferritin from baseline at treatment day 196.|baseline and treatment day 196|ITT, excluding participants with missing data||ng/mL||Standard Deviation|Mean
719855|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 24 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 20:00h.|Baseline (Day -2/ Day -1) 20:00h, Day 43 20:00h|Safety population; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
719856|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 23 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 19:00h.|Baseline (Day -2/ Day -1) 19:00h, Day 43 19:00h|Safety population; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
719857|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 22 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 18:00h.|Baseline (Day -2/ Day -1) 18:00h, Day 43 18:00h|Safety population; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
719858|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 21 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 17:00h.|Baseline (Day -2/ Day -1) 17:00h, Day 43 17:00h|Safety population; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
719859|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 20 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 16:00h.|Baseline (Day -2/ Day -1) 16:00h, Day 43 16:00h|Safety population; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
719860|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 19 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 15:00h.|Baseline (Day -2/ Day -1) 15:00h, Day 43 15:00h|Safety population; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
719861|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 18 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 14:00h.|Baseline (Day -2/ Day -1) 14:00h, Day 43 14:00h|Safety population; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
719862|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 17 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 13:00h.|Baseline (Day -2/ Day -1) 13:00h, Day 43 13:00h|Safety population; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
719899|NCT00293059|Secondary|Change From Baseline in Serum Ferritin Concentration at Treatment Day 84|Serum ferritin was measured before treatment and after 84 days under treatment. A positive value indicates an increase in serum ferritin from baseline at treatment day 84.|baseline and treatment day 84|ITT, excluding participants with missing data||ng/mL||Standard Deviation|Mean
719863|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 16 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 12:00h.|Baseline (Day -2/ Day -1) 12:00h, Day 43 12:00h|Safety population; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
719864|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 15 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 11:00h.|Baseline (Day -2/ Day -1) 11:00h, Day 43 11:00h|Safety population; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
719865|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 14 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 10:00h.|Baseline (Day -2/ Day -1) 10:00h, Day 43 10:00h|Safety population; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
719866|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 13 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 9:00h.|Baseline (Day -2/ Day -1) 9:00h, Day 43 9:00h|Safety population; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
719867|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 12 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 8:00h.|Baseline (Day -2/ Day -1) 8:00h, Day 43 8:00h|Safety population; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
719868|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 11 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 7:00h.|Baseline (Day -2/ Day -1) 7:00h, Day 43 7:00h|Safety population; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
719869|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 10 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 6:00h.|Baseline (Day -2/ Day -1) 6:00h, Day 43 6:00h|Safety population; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
719870|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 9 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 5:00h.|Baseline (Day -2/ Day -1) 5:00h, Day 43 5:00h|Safety population; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
719900|NCT00293059|Secondary|Change From Baseline in Hematocrit (Hct) Concentrations at Treatment Day 196|Hematocrit was measured before treatment and after 196 days under treatment. A positive value indicates an increase in hematocrit from baseline at treatment day 196.|baseline and treatment day 196|ITT, excluding participants with missing data||Percentage of blood volume||Standard Deviation|Mean
719871|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 8 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 4:00h.|Baseline (Day -2/ Day -1) 4:00h, Day 43 4:00h|Safety population; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
719872|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 7 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 3:00h.|Baseline (Day -2/ Day -1) 3:00h, Day 43 3:00h|Safety population; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
719873|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 6 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 2:00h.|Baseline (Day -2/ Day -1) 2:00h, Day 43 2:00h|Safety population; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
719874|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 5 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 1:00h.|Baseline (Day -2/ Day -1) 1:00h, Day 43 1:00h|Safety population; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
719875|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 4 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 00:00h.|Baseline (Day -2/ Day -1) 00:00h, Day 43 00:00h|Safety population; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
719876|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 3 Hours After Patch Application on Day 42(Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 23:00h.|Baseline (Day -2/ Day -1) 23:00h, Day 42 23:00h|Safety population; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
719877|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 2 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 22:00h.|Baseline (Day -2/ Day -1) 22:00h, Day 42 22:00h|Safety population; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
719878|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 1 Hour After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 21:00h.|Baseline (Day -2/ Day -1) 21:00h, Day 42 21:00h|Safety population; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
719901|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Any Medical Treatment) at Treatment Day 196|Participants were asked if they had any medical treatment (eg, prescribed medication, other treatment) because of DUB during the past 12 weeks. The proportion of participants with such treatment is displayed.|treatment day 196|ITT, excluding participants with missing data||Proportion of participants|||Number
719879|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI at Time of Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 20:00h.|Baseline (Day -2/ Day -1) 20:00h, Day 42 20:00h|Safety population; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
719880|NCT00292318|Secondary|Change in Anorectal Physiologic Tests (Absolute Squeeze Pressure)|Measurement of pressure changes by a colonoscope as recorded by a manometric catheter connected to a Polygraph transducer.|The secondary outcome will be determined at the end of the study which will be 20 weeks after starting the study.|Data were not collected due medical instruments to measure this outcome were removed by VA staff causing the study to be terminated.|||||
719881|NCT00292318|Primary|"Patient Report of Adequate Relief From FI Symptoms With a Yes Answer Will be Used as Primary Outcome Variable. Data Will be Recorded at End of Treatment. A Responder Will be Defined as One Who Provides a Yes Answer."|Only reporting the results of participants who reported adequate relief.|The primary outcome will be determined at the end of the study which will be 20 weeks after starting the study.|Only participants that completed the full number of study visits were analyzed.||participants|||Number
719882|NCT00292370|Secondary|PANSS,HAMD,CGI,DTS, PSQI,PSQI-A, Dream/Sleep Diary,Q-LES-Q,SDS,ASEX,AIMS, BAS, SAS||Baseline to endpoint change scores||||||
719883|NCT00292370|Primary|Change in Clinician-Administered PTSD Scale for DSM-IV Total Score.|The Clinician-Administered PTSD Scale for DSM-IV (CAPS) is described in the National Center for PTSD Instruction Manual (November 2000) as a semi-structured clinical interview designed to assess the seventeen symptoms for Post Traumatic Stress Disorder (PTSD) outlined in the DSM-IV, along with five associated features. Ratings are made on a 5 point continuum from the lowest frequency or intensity to the highest. Total CAPS score is a summed score that ranges from 0 to 136 where 0 is asymptomatic and higher scores equal more severe PTSD symptomatology. Also, a change in total CAPS score of 15 points was proposed as clinically significant change.|From baseline (week 8) to endpoint (week 16 or termination)|||units on a scale||Standard Deviation|Mean
719884|NCT00292461|Secondary|Response Rate: Defined as the Percentage of Participants With >= 50% Reduction of Monthly Seizure Frequency at the End of 16-week Treatment From Baseline.||Baseline and 16 weeks|||percentage of participants|||Number
719885|NCT00292461|Secondary|Global Assessment of Efficacy by Participants at the End of the 16-week Treatment Period||Baseline and 16 weeks|||participants|||Number
719886|NCT00292461|Secondary|Global Assessment of Efficacy by Physician at the End of 16-week Treatment Period||Baseline and 16 weeks|||participants|||Number
719887|NCT00292461|Primary|The Percentage Change of Monthly Seizure Frequency at the End of the 16-week Treatment From Baseline|Percentage Change of Frequency = (T-B)/B*100% T= Total seizure frequency during maintenance dose period / maintenance dose period (weeks)* 4 B= The monthly seizure frequence with one month prior to enrollment|Baseline and 16 weeks|ITT (intent-to-treat)||percent change||Full Range|Median
719888|NCT00292591|Primary|25-Hydroxyvitamin D Concentration|Circulating total 25(OH)D concentration measured in serum at visit 7, one month prior to delivery|7 months|||ng/mL||Standard Deviation|Mean
719889|NCT00292981|Secondary|Time to Complete Resolution of All HAE Symptoms (ITT Attack Population)|Complete resolution of symptoms was determined by subject self-assessment and documented on a diary card.|Up to Day 9 following an attack|ITT attack population: All attacks in subjects admitted to the study for which any portion of study medication was administered.||hours|Participants|95% Confidence Interval|Median
719890|NCT00292981|Primary|Time to Start of Relief of Symptoms From HAE Attack (ITT Attack Population)|The start of symptom relief was determined by subject self-assessment.|Up to 24 h after start of study treatment|ITT attack population: All attacks in subjects admitted to the study for which any portion of study medication was administered.||hours|Participants|95% Confidence Interval|Median
719891|NCT00292981|Secondary|Time to Complete Resolution of All HAE Symptoms (ITT Subject Population)|Complete resolution of symptoms was determined by subject self-assessment and documented on a diary card.|Up to Day 9 following an attack|Intent to treat (ITT) subject population: All subjects admitted to the study who received any portion of the study medication.||hours||95% Confidence Interval|Median
719892|NCT00292981|Primary|Time to Start of Relief of Symptoms From HAE Attack (Intent to Treat (ITT) Subject Population)|The start of symptom relief was determined by subject self-assessment.|Up to 24 h after start of study treatment|Intent to treat (ITT) subject population: All subjects admitted to the study who received any portion of the study medication.||hours||95% Confidence Interval|Median
719893|NCT00293020|Primary|Percentage of Participants With Adverse Events.|After the first dose of BEMA Fentanyl, all adverse events were recorded and summarized.|Participants were followed for the duration of the study, an average of 126 days|All subjects that received at least 1 dose of study drug were included in the analysis.||percentage of participants|||Number
719894|NCT00293059|Post-Hoc|Change in Absolute Value From Baseline MBL to end-of Study MBL|The MBL for each cycle includes intermenstrual bleeding in addition to withdrawal bleeding. Baseline MBL was the mean MBL of measured MBL during three cycles in the run-in Phase. One cycle was defined as 28 days. For this analysis, the run-in Phase was defined by the days 1 to 84 (= 3 cycles each of 28 days). End of Study MBL was measured during Cycle 7 of the Treatment Phase (data imputation and Last Observation Carried Forward was applied).|during a time period of 28 days under treatment|Only participants with heavy menstrual bleeding were included in the analysis.||mL||Standard Deviation|Mean
719895|NCT00293059|Post-Hoc|Proportion of Participants With Successful Treatment|End of Study menstrual blood loss (MBL) ≤ 80 mL and a decrease to a value of ≤ 50% of the Baseline MBL was considered as treatment success.|during a time period of 28 days under treatment|Only participants with heavy menstrual bleeding were included in the analysis.||Proportion of participants|||Number
719896|NCT00293059|Secondary|Change From Baseline in Hemoglobin Concentration at Treatment Day 196|Hemoglobin was measured before treatment and after 196 days under treatment. A positive value indicates an increase in hemoglobin from baseline at treatment day 196.|baseline and treatment day 196|ITT, excluding participants with missing data||g/dL||Standard Deviation|Mean
719902|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Out-of-pocket Expenses) at Treatment Day 196|Participants were asked to specify out-of-pocket expenses because of DUB during the past 12 weeks, including over-the-counter medication, co-payments due to prescribed medication, and costs to travel to and from medical appointments. The proportion of participants with such expenses is displayed.|treatment day 196|ITT, excluding participants with missing data||Proportion of participants|||Number
719903|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Received Ambulatory Services) at Treatment Day 196|Participants were asked if they had received ambulatory services (eg, home help, child care) because of DUB during the past 12 weeks. The proportion of participants who had received such services is displayed.|treatment day 196|ITT, excluding participants with missing data||Proportion of participants|||Number
719904|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Additional Unscheduled Procedures) at Treatment Day 196|Participants were asked if they had any unscheduled procedures (eg, laparoscopy, laboratory tests, ultrasound) because of DUB during the past 12 weeks. The proportion of participants with such procedures is displayed.|treatment day 196|ITT, excluding participants with missing data||Proportion of participants|||Number
719905|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Unscheduled Visit to Physician) at Treatment Day 196|Participants were asked if they had any unscheduled visits to a physician (non-hospital medical care) because of DUB during the past 12 weeks, not including visits that were due to participation in this study. The proportion of participants with such visits is displayed.|treatment day 196|ITT, excluding participants with missing data||Proportion of participants|||Number
719906|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Unscheduled Outpatient Visit at Hospital) at Treatment Day 196|Participants were asked if they had any unscheduled outpatient visits to a hospital because of DUB during the past 12 weeks, not including visits that were due to participation in this study. The proportion of participants with such visits is displayed.|treatment day 196|ITT, excluding participants with missing data||Proportion of participants|||Number
719907|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Regular Daily Activities) at Treatment Day 196|Participants were asked to rate on a scale of 0 to 10 how much DUB affected their ability to do regular daily activities, other than work at a job, during the past 12 weeks where 0 represented that DUB had no effect on daily activities and 10 represented that DUB completely prevented her from doing her daily activities.|treatment day 196|ITT, excluding participants with missing data||Scores on a scale||Standard Deviation|Mean
719908|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Productivity While Working) at Treatment Day 196|Participants were asked to rate on a scale of 0 to 10, how much DUB affected their productivity while working during the past 12 weeks, where 0 represented that DUB had no effect on work and 10 represented that DUB completely prevented her from working.|treatment day 196|ITT, excluding participants with missing data||Scores on a scale||Standard Deviation|Mean
719909|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Days Missed From Work) at Treatment Day 196|Participants were asked how many days and hours were missed from work during the past 12 weeks because of problems associated with DUB, not including the time missed to participate in this study.|treatment day 196|ITT, excluding participants with missing data||days||Standard Deviation|Mean
719910|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Change in the Employment Status) at Treatment Day 196|Participants were asked if there was any change in employment status in the last 12 weeks. The proportion of participants with a change is displayed.|treatment day 196|ITT, excluding participants with missing data||Proportion of participants|||Number
719911|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Any Medical Treatment) at Treatment Day 84|Participants were asked if they had any medical treatment (eg, prescribed medication, other treatment) because of DUB during the past 12 weeks. The proportion of participants with such treatment is displayed.|treatment day 84|ITT, excluding participants with missing data||Proportion of participants|||Number
719912|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Out-of-pocket Expenses) at Treatment Day 84|Participants were asked to specify if they had out-of-pocket expenses because of DUB during the past 12 weeks, including over-the-counter medication (the name of the medication, the number of packages, and the cost per package), co-payments due to prescribed medication, and costs to travel to and from medical appointments. The proportion of participants with such expenses is displayed.|treatment day 84|ITT, excluding participants with missing data||Proportion of participants|||Number
719913|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Received Ambulatory Services) at Treatment Day 84|Participants were asked if they had received ambulatory services (eg, home help, child care) because of DUB during the past 12 weeks. The proportion of participants who received such services is displayed.|treatment day 84|ITT, excluding participants with missing data||Proportion of participants|||Number
719914|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Additional Unscheduled Procedures) at Treatment Day 84|Participants were asked if they had any unscheduled procedures (eg, laparoscopy, laboratory tests, ultrasound) because of DUB during the past 12 weeks. The proportion of participants with such procedures is displayed.|treatment day 84|ITT, excluding participants with missing data||Proportion of participants|||Number
719915|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Unscheduled Visit to Physician) at Treatment Day 84|Participants were asked if they had any unscheduled visits to a physician (non-hospital medical care) because of DUB during the past 12 weeks, not including visits that were due to participation in this study. The proportion of participants with such visits is displayed.|treatment day 84|ITT, excluding participants with missing data||Proportion of participants|||Number
719916|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Unscheduled Outpatient Visit at Hospital) at Treatment Day 84|Participants were asked if they had any unscheduled outpatient visits to a hospital because of DUB during the past 12 weeks, not including visits that were due to participation in this study. The proportion of participants with such visits is displayed.|treatment day 84|ITT, excluding participants with missing data||Proportion of participants|||Number
719917|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Regular Daily Activities) at Treatment Day 84|Participants were asked to rate on a scale of 0 to 10 how much DUB affected their ability to do their regular daily activities, other than work at a job, during the past 12 weeks where 0 represented that DUB had no effect on daily activities and 10 represented that DUB completely prevented her from doing daily activities.|treatment day 84|ITT, excluding participants with missing data||Scores on a scale||Standard Deviation|Mean
719918|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Productivity While Working) at Treatment Day 84|Participants were asked to rate on a scale of 0 to 10, how much their DUB affected productivity while working during the past 12 weeks, where 0 represented that DUB had no effect on work and 10 represented that DUB completely prevented her from working.|treatment day 84|ITT, excluding participants with missing data||Scores on a scale||Standard Deviation|Mean
719919|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Days Missed From Work) at Treatment Day 84|Participants were asked how many days and hours they missed from work during the past 12 weeks because of problems associated with DUB, not including the time missed to participate in this study.|treatment day 84|ITT, excluding participants with missing data||day||Standard Deviation|Mean
719920|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Change in the Employment Status) at Treatment Day 84|Participants were asked if there was any change in her employment status in the last 12 weeks. The proportion of participants with a change is displayed.|treatment day 84|ITT, excluding participants with missing data||Proportion of participants|||Number
719921|NCT00293059|Secondary|Change From Baseline in Visual Analogue Scale (VAS) of the EQ-5D Score at Treatment Day 196|The visual analogue scale (ie, “thermometer”) had endpoints of 100 (best imaginable health state) at the top, and 0 (worst imaginable health state) at the bottom. Participants rated their current health state by drawing a line from the box marked ‘your own health state today’ to the appropriate point on the thermometer scale. The change from baseline at day 196 is presented.|baseline and treatment day 196|ITT, excluding participants with missing data||Scores on a scale||Standard Deviation|Mean
719922|NCT00293059|Secondary|Change From Baseline in Visual Analogue Scale (VAS) of the EQ-5D Score at Treatment Day 84|The visual analogue scale (ie, “thermometer”) had endpoints of 100 (best imaginable health state) at the top, and 0 (worst imaginable health state) at the bottom. Participants rated their current health state by drawing a line from the box marked ‘your own health state today’ to the appropriate point on the thermometer scale. The change from baseline at day 84 is presented.|baseline and treatment day 84|ITT, excluding participants with missing data||Scores on a scale||Standard Deviation|Mean
719923|NCT00293059|Secondary|Change From Baseline in EuroQoL (Quality of Life) 5 Dimensional Health Questionnaire (EQ-5D) Scores at Treatment Day 196|The Health State Classification of the EQ-5D comprised 5 questions addressing mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Participants were asked to indicate their current health state by ticking the most appropriate of 3 statements about each of the questions (ie, no problems, some problems, extreme problems). The best possible answers were (1,1,1,1,1), which equals a valuation score of 1.0. The worst possible answers were (3,3,3,3,3), which equals a valuation score of .594. The change from the baseline score at day 196 is presented.|baseline and treatment day 196|ITT, excluding participants with missing data||Scores on a scale||Standard Deviation|Mean
719924|NCT00293059|Secondary|Change From Baseline in EuroQoL (Quality of Life) 5 Dimensional Health Questionnaire (EQ-5D) Scores at Treatment Day 84|The Health State Classification of the EQ-5D comprised 5 questions addressing mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Participants were asked to indicate their current health state by ticking the most appropriate of 3 statements about each of the questions (ie, no problems, some problems, extreme problems). The best possible answers were (1,1,1,1,1), which equals a valuation score of 1.0. The worst possible answers were (3,3,3,3,3), which equals a valuation score of .594. The change from the baseline score at day 84 is presented.|baseline and treatment day 84|ITT, excluding participants with missing data||scores on a scale||Standard Deviation|Mean
719925|NCT00293059|Secondary|Change From Baseline in McCoy Female Sexuality Questionnaire (MFSQ) Scores at Treatment Day 196|The MFSQ was designed to measure aspects of female sexuality and asked about the participants’ sexual experience during the last 4 weeks. Higher scores represent higher, more complete, or better integrated levels of female sexual function. Minimum and maximum possible values are 19 and 133.|baseline and treatment day 196|ITT, excluding participants with missing data||Scores on a scale||Standard Deviation|Mean
719926|NCT00293059|Secondary|Change From Baseline in McCoy Female Sexuality Questionnaire (MFSQ) Scores at Treatment Day 84|The MFSQ was designed to measure aspects of female sexuality and asked about the participants’ sexual experience during the last 4 weeks. Higher scores represent higher, more complete, or better integrated levels of female sexual function. Minimum and maximum possible values are 19 and 133.|baseline and treatment day 84|ITT, excluding participants with missing data||Scores on a scale||Standard Deviation|Mean
719927|NCT00293059|Secondary|Change From Baseline in Psychological General Well-Being Index (PGWBI) Scores at Treatment Day 196|The PGWBI questionnaire consisted of 22 questions that were answered using a 6-grade Likert scale. The minimum overall score was 22 and the maximum was 132. The higher the score, the better the well being of the participant. The observation phase was the last 4 weeks. The following 6 dimensions were derived from the questionnaire: anxiety, depressed mood, positive well-being, self-control, health, and vitality and the highest possible scores were 30, 18, 24, 18, 18, and 24, respectively.|baseline and treatment day 196|ITT, excluding participants with missing data||Scores on a scale||Standard Deviation|Mean
719928|NCT00293059|Secondary|Change From Baseline in Psychological General Well-Being Index (PGWBI) Scores at Treatment Day 84|The PGWBI questionnaire consisted of 22 questions that were answered using a 6-grade Likert scale. The minimum overall score was 22 and the maximum was 132. The higher the score, the better the well being of the participant. The observation phase was the last 4 weeks. The following 6 dimensions were derived from the questionnaire: anxiety, depressed mood, positive well-being, self-control, health, and vitality and the highest possible scores were 30, 18, 24, 18, 18, and 24, respectively.|baseline and treatment day 84|ITT, excluding participants with missing data||Scores on a scale||Standard Deviation|Mean
721021|NCT00317941|Secondary|Mean Pain Assessment Using Visual Analogue Scale (VAS) Reported by Participants 1 Hour After Injection|Visual analogue scale was used to report the pain from 0 (no pain ) to 10 (maximal pain).|1h after injection|||Scores on a scale||Full Range|Mean
719929|NCT00293059|Secondary|Change From Baseline in Number of Sanitary Protection Used at 90 Days of Treatment|The number of total sanitary protection items used during the 90-day run-in phase before treatment (baseline) and the number of total sanitary protection items used during the 90 days while under treatment was determined. A negative value indicates a reduction in the number of sanitary protection items used while under treatment compared to the number used before treatment.|baseline and reference period of 90 days under treatment|ITT, excluding participants with missing data||Sanitary protection products||Standard Deviation|Mean
719930|NCT00293059|Secondary|Change From Baseline in Number of Bleeding Episodes to the Reference Period of 90 Days Under Treatment|A bleeding episode was one that lasted for at least 2 days, and where the bleeding days were separated by no more than 1 bleeding-free day. An episode stopped with 2 consecutive bleeding-free days. The number of episodes was determined for the 90 days before treatment and for the 90 days under treatment. A negative values indicates a reduction from baseline in the number of episodes while under treatment.|baseline and reference period of 90 days under treatment|ITT, excluding participants with missing data||bleeding episodes||Standard Deviation|Mean
719931|NCT00293059|Secondary|Change From Baseline in Number of Bleeding Days to the Reference Period of 90 Days Under Treatment|The number of bleeding days was determine for the 90 days before treatment (baseline) and for 90 days while under treatment. A negative value indicates a reduction in the number of bleeding days while under treatment compared to baseline.|baseline and reference period of 90 days under treatment|ITT, excluding participants with missing data||bleeding days||Standard Deviation|Mean
719932|NCT00293059|Secondary|Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 7|The blood loss volume for participants with excessive bleeding (2 or more bleeding episodes each with blood loss volume of 80 mL or more during the run-in phase) was determined using the alkaline hematin method after participants were on treatment for 7 cycles.|28 days|ITT, participants with excessive bleeding at baseline||mL||Standard Deviation|Mean
719933|NCT00293059|Secondary|Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 3|The blood loss volume for participants with excessive bleeding (2 or more bleeding episodes each with blood loss volume of 80 mL or more during the run-in phase) was determined using the alkaline hematin method after participants were on treatment for 3 cycles.|28 days|ITT, participants with excessive bleeding at baseline||mL||Standard Deviation|Mean
719934|NCT00293059|Secondary|Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 1|The blood loss volume for participants with excessive bleeding (2 or more bleeding episodes each with blood loss volume of 80 mL or more during the run-in phase) was determined using the alkaline hematin method after participants were on treatment for one cycle.|28 days|ITT, participants with excessive bleeding at baseline||mL||Standard Deviation|Mean
719935|NCT00293059|Secondary|Change From Baseline in Blood Loss Volume for Participants With Excessive Bleeding to the Reference Period of 90 Days Under Treatment|The blood loss volume for participants with excessive bleeding (2 or more bleeding episodes each with blood loss volume of 80 mL or more during the run-in phase) was determined for the 90 days before treatment (ie, run-in phase) and for the 90 days under treatment. A negative value indicates a reduction in blood loss while under treatment compared to before treatment.|baseline and reference period of 90 days under treatment|ITT, participants with excessive bleeding at baseline||mL||Standard Deviation|Mean
719936|NCT00293059|Secondary|Menstrual Blood Loss Volume for All Participants at Cycle 7|Menstrual blood loss volume was determined using the alkaline hematin methods after participants were on treatment for 7 cycles|28 days|ITT, excluding participants with missing data||mL||Standard Deviation|Mean
719937|NCT00293059|Secondary|Menstrual Blood Loss Volume for All Participants at Cycle 3|Menstrual blood loss volume was determined using the alkaline hematin method after participants were on treatment for 3 cycles|28 days|ITT, excluding participants with missing data||mL||Standard Deviation|Mean
719938|NCT00293059|Secondary|Menstrual Blood Loss Volume for All Participants at Cycle 1|Menstrual blood loss volume was determined using the alkaline hematin method after participants were on treatment for one cycle|28 days|ITT, excluding participants with missing data||mL||Standard Deviation|Mean
719939|NCT00293059|Secondary|Change From Baseline in Blood Loss Volume for All Participants to the Reference Period of 90 Days Under Treatment|Menstrual blood loss was determined using the alkaline hematin method for the 90 days before treatment (baseline) and for 90 days under treatment. A negative value indicates a reduction in blood loss after treatment.|Baseline and reference period of 90 days under treatment|ITT, excluding participants with missing data||mL||Standard Deviation|Mean
719940|NCT00293059|Secondary|Proportion of Participants With Improvement in the Participant’s Overall Assessment Scale at Treatment Day 196|Participants assessed their overall improvement at day 196 (visit 11) compared with their condition at admission to the study on a scale of 1 (very much improved) to 7 (very much worse). Improvement was defined as being classified as a score of 3 or less.|from baseline up to treatment day 196|ITT, excluding participants with missing data||Proportion of participants|||Number
719941|NCT00293059|Secondary|Proportion of Participants With Improvement in the Participant’s Overall Assessment Scale at Treatment Day 84|Participants assessed their overall improvement at day 84 (visit 7) compared with their condition at admission to the study on a scale of 1 (very much improved) to 7 (very much worse). Improvement was defined as being classified as a score of 3 or less.|from baseline up to treatment day 84|ITT, excluding participants with missing data||Proportion of participants|||Number
719942|NCT00293059|Secondary|Proportion of Participants With Improvement in the Investigator’s Global Assessment Scale at Treatment Day 196|The investigators assessed the participants’ change in DUB symptoms at day 196 (visit 11) compared with admission to the study according to a scale of 1 (very much improved) to 7 (very much worse), using the following information: central laboratory data, physical examination, e-diary data, and participant interview. Improvement was defined as being classified as a score of 3 or less.|from baseline up to treatment day 196|ITT, excluding participants with missing data||Proportion of participants|||Number
719943|NCT00293059|Secondary|Proportion of Participants With Improvement in the Investigator’s Global Assessment Scale at Treatment Day 84|The investigators assessed the participants’ change in DUB symptoms at day 84 (visit 7) compared with admission to the study according to a scale of 1 (very much improved) to 7 (very much worse), using the following information: central laboratory data, physical examination, e-diary data, and participant interview. Improvement was defined as being classified as a score of 3 or less.|from baseline up to treatment day 84|ITT, excluding participants with missing data||Proportion of participants|||Number
719944|NCT00293059|Secondary|Proportion of Participants Cured From Excessive Bleeding|Excessive bleeding was defined as 2 or more bleeding episodes each with blood loss volume of 80 mL or more in a 90-day period. Participants were considered cured if (1) the blood loss volume associated with each episode was less than 80 mL and (2) the blood loss volume associated with each bleeding episode represented a decrease of at least 50% from the average of the qualifying bleeding episodes, where the qualifying bleeding episodes were those with a blood loss volume ≥ 80 mL (per episode) that occurred during the run-in phase.|during a time period of 90 days under treatment|The ITT population consisted of all randomized participants who enrolled with excessive bleeding.||Proportion of participants|||Number
719945|NCT00293059|Secondary|Proportion of Participants Cured From Frequent Bleeding|Frequent bleeding was defined as greater than 5 bleeding episodes, with a minimum of 20 bleeding days overall in a 90-day period. Participants were considered cured if they had no more than 4 bleeding episodes and the total number of bleeding days did not exceed 24 days and there was no increase in the total number of bleeding days in the efficacy phase as compared to the run-in phase.|during a time period of 90 days under treatment|The ITT population consisted of all randomized participants who enrolled with frequent bleeding.||Proportion of participants|||Number
719946|NCT00293059|Secondary|Proportion of Participants Cured From Prolonged Bleeding|Prolonged bleeding was defined as 2 or more bleeding episodes, each lasting 8 or more days in a 90-day period. Participants were considered cured if they had no bleeding episodes lasting more than 7 days and the decrease between the maximum duration during the run-in phase and the maximum duration during the efficacy phase was at least 2 days.|during a time period of 90 days under treatment|The ITT population consisted of all randomized participants who enrolled with prolonged bleeding.||Proportion of participants|||Number
719947|NCT00293059|Primary|Proportion of Participants With no Dysfunctional Uterine Bleeding (DUB) Symptoms|Up to 8 criteria had to be met for complete response during 90-day period. No bleeding episodes (BE) >7 days, no >4 BE, no BE with MBL >=80 mL, no >1 BE increase from baseline, no increase from baseline in an individual participant’s total number of bleeding days and total number of bleeding days not >24 days. Additionally, for participants included with prolonged bleeding: decrease between maximum duration during run-in and efficacy >=2 days excessive bleeding: MBL associated with each episode decreased by >=50% from average of qualifying episodes during run-in.|during a time period of 90 days under treatment|The intent-to-treat (ITT) group consisted of all randomized participants.||Proportion of participants|||Number
719948|NCT00293241|Secondary|Health State|Endpoint: Health State evaluation with the EQ-5D questionnaire (range 0-100) . A measure of 100 is better and a measure of 0 is worse.|2 years post-implant|Patients with health evaluation completed at 24 months follow-up||units on a Health State scale||Standard Deviation|Mean
719949|NCT00293241|Secondary|Atrial Pacing Percentage|Endpoint: Cumulative percentage atrial pacing documented in the device memory|2 years post-implant|||percentage atrial pacing||Inter-Quartile Range|Median
719950|NCT00293241|Secondary|Patient Symptoms|Endpoint: Symptoms evaluated at enrollment, 12 months and 24 months followup|Implant to 2 years post-implant|||participants|||Number
719951|NCT00293241|Secondary|Change in PR Interval, Change in QRS Duration and Change in P-wave Duration|Endpoint: Change in PR interval, Change in QRS duration and Change in P-wave duration evaluated at enrollment and 24 Month FU|Implant to 2 years post-implant|||milliseconds||Standard Deviation|Mean
719952|NCT00293241|Secondary|Incidence of Class I Pacemaker (Implantable Pulse Generator = IPG) Indication in Implantable Cardioverter Defibrillator (ICD) Patients|Endpoint: Patient implanted with a replacement ICD developing a class 1 pacemaker indication|Implant to 2 years post-implant|||participants|||Number
719953|NCT00293241|Secondary|Duration of Cardiovascular Related Hospitalizations|Endpoint: Duration of Cardiovascular Hospitalizations per subject|Implant to 4 years post-implant|All participants were followed for 4 years. Those not hospitalized were excluded from the analysis.||Days of CV hospitalizations||Inter-Quartile Range|Median
719954|NCT00293241|Secondary|Number of Cardiovascular Related Hospitalizations|Endpoint: Number of Cardiovascular hospitalizations per subject|Implant to 4 years post-implant|All participants were followed for 4 years. Those not hospitalized were excluded from the analysis.||Number of CV Hospitalizations||Inter-Quartile Range|Median
719955|NCT00293241|Secondary|Stroke|Endpoint: Stroke|Implant to 2 years post-implant|||participants|||Number
719956|NCT00293241|Secondary|Time to Event Analysis: Number of Patients Who Died Within 2 Years Post-implant|Time to patient death from any cause|Implant to 2 years post-implant|||participants|||Number
719957|NCT00293241|Secondary|Incidence of High Voltage Therapies|Endpoint: A high voltage therapy delivered|Implant to 2 years post-implant|||participants|||Number
719958|NCT00293241|Secondary|Change in the Use of Cardiovascular Medication Over Time|Endpoint: Use of Diuretics, ACE Inhibitors, Beta-Blockers, digitalis, calcium antagonists and antiarrhythmic drugs at enrollment, and 1month, 12 months, and 24 mnths after implant|Implant to 2 years post-implant|||participants|||Number
719959|NCT00293241|Secondary|Change in Use of Anticoagulation|Endpoint: Use of Anticoagulation at enrollment and every follow-up visit|Implant to 2 years post-implant|||participants|||Number
719960|NCT00293241|Secondary|Change in New York Heart Association (NYHA) Functional Class|"Endpoint: NYHA classification at Baseline, one year and 2 year post-implant. (Class I is considered a better category and Class IV is considered worse) I Patients with cardiac disease but resulting in no limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea or anginal pain.
II Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea or anginal pain.
III Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea or anginal pain.
IV Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort increases."|Baseline, one year and 2 year post-implant|||Participants|||Number
719961|NCT00293241|Secondary|Change in Left Ventricular Ejection Fraction (LVEF,%) Over 2 Years Time|Endpoint: LVEF (%) difference between 2 year post implant and baseline|Implant to 2 years post-implant|||LVEF (%) difference||Standard Deviation|Mean
719962|NCT00293241|Secondary|Ventricular Pacing Percentage|Endpoint: Cumulative percentage ventricular pacing documented in the device memory|Implant to 2 years post-implant|||Percentage Ventricular Pacing||Inter-Quartile Range|Median
719963|NCT00293241|Secondary|Time to Event Analysis: Number of Patients With Permanent AF Within 2 Years Post-implant|"Time to development of permanent AF fulfilling one of the following criteria:
7 days in a row with device diagnostic showing 20 or more hours in AT/AF and cardioversion failed or
7 days in a row with device diagnostic showing 20 or more hours in AT/AF and the investigator decides not to cardiovert the patient"|Implant to 2 years post-implant|||participants|||Number
719964|NCT00293241|Secondary|Time to Event Analysis: Number of Patients With Persistent AT/AF Within 2 Years Post-implant|"Time to first event of atrial tachycardia/ atrial fibrillation (AT/AF) fulfilling one of the following criteria:
7 days in a row with device diagnostic showing 20 or more hours in AT/AF or
a cardioversion was done to terminate AT/AF or
the patient is during 2 consecutive follow-up (FU) visits in AT/AF"|Implant to 2 years post-implant|||participants|||Number
719965|NCT00293241|Secondary|Time to Event Analysis: Number of Patients Who Experienced Death or First Cardiovascular (CV) Hospitalization Within 2 Years Post-implant.|Time to first event of death or cardiovascular (CV) hospitalization from implant to 2 years post-implant|Implant to 2 years post-implant|||participants|||Number
719966|NCT00293241|Primary|Time to Event Analysis: Number of Patients Who Experienced the First Cardiovascular Hospitalization Within 2 Years Post-implant|"Time to first event of cardiovascular (CV) hospitalization from implant to 2 years post-implant.
Hospitalization is defined as:
admission to hospital involving one overnight stay or
emergency room / office visits that result in cardioversions or acute treatment of worsened cardiac condition
Cardiovascular is defined as new or worsening:
heart failure (HF),
angina,
myocardial infarction (MI),
any arrhythmia,
stroke,
transient ischemic attack (TIA),
acute peripheral vascular emergencies,
pulmonary embolism."|Implant to 2 years post-implant|Patients indicated for Implantable Pulse Generator (IPG) or Implantable Cardioverter Defibrillator (ICD) replacement with a history of right ventricular pacing > 40%, to be allocated to either Managed Ventricular Pacing (MVP) programming, or conventional dual chamber programming (DDD) without MVP||number of participants|||Number
719967|NCT00293254|Secondary|Open-Label Extension - Week 240: Change From Baseline in CD4 Cell Count (Cells/mm^3)|Mean change from baseline at Week 240 in CD4 cell count (cells/mm^3)|Baseline and Week 240|"Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 cell count (cells/mm^3) was carried forward for participants who discontinued assigned therapy due to lack of efficacy.
Participants with virologic failure after Week 16 are treatment failures for virologic efficacy analyses."||CD4 Cell Count (Cells/mm^3)||95% Confidence Interval|Mean
719968|NCT00293254|Secondary|Double-Blind Extension - Week 156: Change From Baseline in CD4 Cell Count(Cells/mm^3)|Mean change from baseline at Week 156 in CD4 cell count (cells/mm^3)|Baseline and Week 156|"Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 cell count (cells/mm^3) was carried forward for participants who discontinued assigned therapy due to lack of efficacy.
Participants with virologic failure after Week 16 are treatment failures for virologic efficacy analyses."||CD4 Cell Count (cells/mm^3)||95% Confidence Interval|Mean
719969|NCT00293254|Secondary|Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 48|Mean change from baseline at Week 48 in CD4 cell count (cells/mm^3)|Baseline and Week 48|"Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 cell count (cells/mm^3) was carried forward for participants who discontinued assigned therapy due to lack of efficacy.
Participants with virologic failure after Week 16 are treatment failures for virologic efficacy analyses."||CD4 Cell Count (cells/mm^3)||95% Confidence Interval|Mean
719970|NCT00293254|Secondary|Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 16|Mean change from baseline at Week 16 in CD4 cell count (cells/mm^3)|Baseline and Week 16|Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 cell count (cells/mm^3) was carried forward for participants who discontinued assigned therapy due to lack of efficacy.||CD4 Cell Count (cells/mm^3)||95% Confidence Interval|Mean
719971|NCT00293254|Secondary|Open-Label Extension - Week 240: Change From Baseline in HIV RNA (log10 Copies/mL)|Mean change from baseline at Week 240 in HIV RNA (log10 copies/mL)|Baseline and Week 240|"Observed mean change from baseline in log10 plasma HIV RNA calculated using conventional imputation (replace <400 copies by 400 copies if signal detected; 200 copies if not detected); Missing values: Baseline carry-forward for all failures/discontinued due to lack of efficacy
Participants with virologic failure after Week 16 = treatment failures"||HIV RNA (log10 copies/mL)||95% Confidence Interval|Mean
719972|NCT00293254|Secondary|Double-Blind Extension - Week 156: Change From Baseline in HIV RNA (log10 Copies/mL)|Mean change from baseline at Week 156 in HIV RNA (log10 copies/mL)|Baseline and Week 156|Observed mean change from baseline in log10 plasma HIV RNA calculated using conventional imputation (replace <400 copies by 400 copies if signal detected; 200 copies if not detected); Missing values: Baseline carry-forward for all failures/discontinued due to lack of efficacy||HIV RNA (log10 copies/mL)||95% Confidence Interval|Mean
719973|NCT00293254|Secondary|Change From Baseline in HIV RNA (log10 Copies/mL) at Week 48|Mean change from baseline at Week 48 in HIV RNA (log10 copies/mL)|Baseline and Week 48|Observed mean change from baseline in log10 plasma HIV RNA calculated using conventional imputation (replace <400 copies by 400 copies if signal detected; 200 copies if not detected); Missing values: Baseline carry-forward for all failures/discontinued due to lack of efficacy||HIV RNA (log10 copies/mL)||95% Confidence Interval|Mean
719974|NCT00293254|Secondary|Change From Baseline in HIV RNA (Log 10 Copies/mL) at Week 16|Mean change from baseline at Week 16 in HIV RNA (log 10 copies/mL)|Baseline and Week 16|Observed mean change from baseline in log10 plasma HIV RNA calculated using conventional imputation (replace <400 copies by 400 copies if signal detected; 200 copies if not detected); Missing values: Baseline carry-forward for all failures/discontinued due to lack of efficacy||HIV RNA (log10 copies/mL)||95% Confidence Interval|Mean
719975|NCT00293254|Secondary|Double-Blind Extension - Week 156: Percentage of Participants Without Loss of Virologic Response|For participants with confirmed HIV RNA levels <50 copies/mL on 2 consecutive visits, loss of virologic response is the occurrence of the first value >50 copies/mL or loss to follow-up; participants who never achieved HIV RNA <50 copies/mL on 2 consecutive visits are also considered as having loss of virologic response. Events are the numbers of participants with loss of virologic response versus the numbers of participants with no loss of virologic response (event-free).|156 Weeks|Participants who experienced virologic failure after Week 16 are also counted as treatment failures for the subsequent virologic efficacy analyses.||Percentage of Participants|||Number
719976|NCT00293254|Secondary|Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <50 Copies/mL|Percentage of participants who achieved HIV RNA <50 copies/mL at Week 240|240 Weeks|Participants who experienced virologic failure after Week 16 are also counted as treatment failures for the subsequent virologic efficacy analyses.||Percentage of Participants||95% Confidence Interval|Number
719977|NCT00293254|Secondary|Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <50 Copies/mL|Percentage of participants who achieved HIV RNA <50 copies/mL at Week 156|156 Weeks|Participants who experienced virologic failure after Week 16 are also counted as treatment failures for the subsequent virologic efficacy analyses.||Percentage of Participants||95% Confidence Interval|Number
719978|NCT00293254|Secondary|Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 48|Percentage of participants who achieved HIV RNA <50 copies/mL at Week 48|48 Weeks|Participants who experienced virologic failure after Week 16 are also counted as treatment failures for the subsequent virologic efficacy analyses.||Percentage of Participants||95% Confidence Interval|Number
719979|NCT00293254|Secondary|Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 16|Percentage of participants who achieved HIV RNA <50 copies/mL at Week 16|16 Weeks|||Percentage of Participants||95% Confidence Interval|Number
719980|NCT00293254|Primary|Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <400 Copies/mL|Percentage of participants who achieved HIV RNA <400 Copies/mL at Week 240|240 Weeks|"The analysis population was based on a non-completer equals failure approach where missing values for participants who discontinued the study for any reason were considered treatment failures.
Participants who experienced virologic failure after Week 16 are counted also as treatment failures for the subsequent virologic efficacy analyses."||Percentage of Participants||95% Confidence Interval|Number
719981|NCT00293254|Primary|Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <400 Copies/mL|Percentage of participants who achieved HIV RNA <400 copies/mL at Week 156|156 Weeks|"The analysis population was based on a non-completer equals failure approach where missing values for participants who discontinued the study for any reason were considered treatment failures.
Participants who experienced virologic failure after Week 16 are counted also as treatment failures for the subsequent virologic efficacy analyses."||Percentage of Participants||95% Confidence Interval|Number
719982|NCT00293254|Primary|Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 48|Percentage of participants who achieved HIV RNA <400 copies/mL at Week 48|48 Weeks|||Percentage of Participants||95% Confidence Interval|Number
719983|NCT00293254|Primary|Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 16|Percentage of participants who achieved HIV RNA <400 copies/mL at Week 16|16 Weeks|||Percentage of Participants||95% Confidence Interval|Number
719984|NCT00293267|Secondary|Open-Label Extension - Week 240: Change From Baseline in CD4 Cell Count (Cells/mm^3)|Mean change from baseline at Week 240 in CD4 Cell Count (cells/mm^3)|Baseline and Week 240|"Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 cell count (cells/mm^3) was carried forward for participants who discontinued assigned therapy due to lack of efficacy.
Participants with virologic failure after Week 16 are treatment failures for virologic efficacy analyses."||CD4 Cell Count (cells/mm^3)||95% Confidence Interval|Mean
719985|NCT00293267|Secondary|Double-Blind Extension - Week 156: Change From Baseline in CD4 Cell Count (Cells/mm^3)|Mean change from baseline at Week 156 in CD4 Cell Count (cells/mm^3)|Baseline and Week 156|"Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 cell count (cells/mm^3) was carried forward for participants who discontinued assigned therapy due to lack of efficacy.
Participants with virologic failure after Week 16 are treatment failures for virologic efficacy analyses."||CD4 Cell Count (cells/mm^3)||95% Confidence Interval|Mean
719986|NCT00293267|Primary|Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <400 Copies/mL|Percentage of participants who achieved HIV RNA <400 Copies/mL at Week 240|240 Weeks|"The analysis population was based on a non-completer equals failure approach where missing values for participants who discontinued the study for any reason were considered treatment failures.
Participants who experienced virologic failure after Week 16 are also counted as treatment failures for the subsequent virologic efficacy analyses."||Percentage of Participants||95% Confidence Interval|Number
719987|NCT00293267|Secondary|Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 48|Mean change from baseline at Week 48 in CD4 Cell Count (cells/mm^3)|Baseline and Week 48|"Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 cell count (cells/mm^3) was carried forward for participants who discontinued assigned therapy due to lack of efficacy.
Participants with virologic failure after Week 16 are treatment failures for virologic efficacy analyses."||CD4 Cell Count (cells/mm^3)||95% Confidence Interval|Mean
719988|NCT00293267|Secondary|Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 16|Mean change from baseline at Week 16 in CD4 Cell Count (cells/mm^3)|Baseline and Week 16|Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 cell count (cells/mm^3) was carried forward for participants who discontinued assigned therapy due to lack of efficacy.||CD4 Cell Count (cells/mm^3)||95% Confidence Interval|Mean
719989|NCT00293267|Primary|Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <400 Copies/mL|Percentage of participants who achieved HIV RNA <400 copies/mL at Week 156|156 Weeks|"The analysis population was based on a non-completer equals failure approach where missing values for participants who discontinued the study for any reason were considered treatment failures.
Participants who experienced virologic failure after Week 16 are counted also as treatment failures for the subsequent virologic efficacy analyses."||Percentage of Participants||95% Confidence Interval|Number
719990|NCT00293267|Secondary|Open-Label Extension - Week 240: Change From Baseline in HIV RNA (log10 Copies/mL)|Mean change from baseline at Week 240 in HIV RNA (log10 copies/mL)|Baseline and Week 240|"Observed mean change from baseline in log10 plasma HIV RNA calculated using conventional imputation (replace <400 copies by 400 copies if signal detected; 200 copies if not detected); Missing values: baseline carry-forward for all failures/discontinued due to lack of efficacy
Participants with virologic failure after Week 16 = treatment failures"||HIV RNA (log10 copies/mL)||95% Confidence Interval|Mean
720008|NCT00293293|Secondary|Average Anti-Emetic Dose Use After Chemotherapy Plus CAM|Determined by averaging the total dose of anti-emetic medications given (in milligrams) per patient after receiving chemotherapy and complementary alternative medicine.|Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)|||Dose (mg) per participant||Standard Deviation|Mean
719991|NCT00293267|Secondary|Double-Blind Extension - Week 156: Change From Baseline in HIV RNA (log10 Copies/mL)|Mean change from baseline at Week 156 in HIV RNA (log10 copies/mL)|Baseline and Week 156|"Observed mean change from baseline in log10 plasma HIV RNA calculated using conventional imputation (replace <400 copies by 400 copies if signal detected; 200 copies if not detected); Missing values: baseline carry-forward for all failures/discontinued due to lack of efficacy
Participants with virologic failure after Week 16 = treatment failures"||HIV RNA (log10 copies/mL)||95% Confidence Interval|Mean
719992|NCT00293267|Secondary|Change From Baseline in HIV RNA (log10 Copies/mL) at Week 48|Mean change from baseline at Week 48 in HIV RNA (log10 copies/mL)|Baseline and Week 48|"Observed mean change from baseline in log10 plasma HIV RNA calculated using conventional imputation (replace <400 copies by 400 copies if signal detected; 200 copies if not detected); Missing values: baseline carry-forward for all failures/discontinued due to lack of efficacy
Participants with virologic failure after Week 16 = treatment failures"||HIV RNA (log10 copies/mL)||95% Confidence Interval|Mean
719993|NCT00293267|Secondary|Change From Baseline in HIV RNA (log10 Copies/mL) at Week 16|Mean change from baseline at Week 16 in HIV RNA (log10 copies/mL)|Baseline and Week 16|"Observed mean change from baseline in log10 plasma HIV RNA calculated using conventional imputation (replace <400 copies by 400 copies if signal detected; 200 copies if not detected); Missing values: baseline carry-
forward for all failures/discontinued due to lack of efficacy"||HIV RNA (log10 copies/mL)||95% Confidence Interval|Mean
719994|NCT00293267|Secondary|Double-Blind Extension - Week 156: Percentage of Participants Without Loss of Virologic Response|For participants with confirmed HIV RNA levels <50 copies/mL on 2 consecutive visits, loss of virologic response is the occurrence of the first value >50 copies/mL or loss to follow-up; participants who never achieved HIV RNA <50 copies/mL on 2 consecutive visits are also considered as having loss of virologic response. Events are the numbers of participants with loss of virologic response versus the numbers of participants with no loss of virologic response (event free).|156 weeks|Participants who experienced virologic failure after Week 16 are also counted as treatment failures for the subsequent virologic efficacy analyses.||Percentage of Participants|||Number
719995|NCT00293267|Primary|Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 48|Percentage of participants who achieved HIV RNA <400 copies/mL at Week 48|48 Weeks|Participants who experienced virologic failure after Week 16 are also counted as treatment failures for the subsequent virologic efficacy analyses.||Percentage of Participants||95% Confidence Interval|Number
719996|NCT00293267|Secondary|Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <50 Copies/mL|Percentage of participants who achieved HIV RNA <50 copies/mL at Week 240|240 weeks|Participants who experienced virologic failure after Week 16 are also counted as treatment failures for the subsequent virologic efficacy analyses.||Percentage of Participants||95% Confidence Interval|Number
719997|NCT00293267|Secondary|Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <50 Copies/mL|Percentage of participants who achieved HIV RNA <50 copies/mL at Week 156|156 weeks|Participants who experienced virologic failure after Week 16 are also counted as treatment failures for the subsequent virologic efficacy analyses.||Percentage of Participants||95% Confidence Interval|Number
719998|NCT00293267|Secondary|Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 48|Percentage of participants who achieved HIV RNA <50 copies/mL at Week 48|48 Weeks|Participants who experienced virologic failure after Week 16 are also counted as treatment failures for the subsequent virologic efficacy analyses.||Percentage of Participants||95% Confidence Interval|Number
719999|NCT00293267|Secondary|Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 16|Percentage of participants who achieved HIV RNA <50 copies/mL at Week 16|16 Weeks|||Percentage of Participants||95% Confidence Interval|Number
720000|NCT00293267|Primary|Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 16|Percentage of participants who achieved HIV RNA <400 copies/mL at Week 16|16 Weeks|||Percentage of Participants||95% Confidence Interval|Number
720001|NCT00293293|Secondary|Comparison of Average Salivary IgA Level in Chemotherapy Alone vs. Chemotherapy Plus CAM|Determined from collection of saliva during treatment phase of study and recorded in mg/dL units.|Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)|||mg/dL||Standard Deviation|Mean
720002|NCT00293293|Secondary|Comparison of Average T-lymphocytes and B-lymphocytes for Chemotherapy Alone vs. Chemotherapy Plus CAM|Average count determined - collected during treatment phase of study - Includes T-helper/inducer, CD4 and CD8 cells; number of CD4 and CD8 cells (in mm^3).|Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)|||cells/mm^3||Standard Deviation|Mean
720003|NCT00293293|Secondary|Comparison of Average White Blood Cell Count in Chemotherapy Alone vs. Chemotherapy Plus CAM|Determined from white blood cell counts collected during treatment phase of study; average applied.|Prior to Chemotherapy through 6th Treatment with Chemotherapy (average 6 months)|||cells/mm^3||Standard Deviation|Mean
720004|NCT00293293|Secondary|Comparison of Number of Patients Who Were Hospitalized After Chemotherapy Alone vs. Chemotherapy Plus CAM|Count of patients who were admitted to the hospital after receiving chemotherapy treatment or chemotherapy plus complementary alternative medicine.|Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)|||Participants|||Number
720005|NCT00293293|Secondary|Comparison of Number of Patients Having Infection After Chemotherapy Alone vs. Chemotherapy Plus CAM|Number of patients that had infections requiring antibiotic therapy or admission to the hospital that received either chemotherapy alone or chemotherapy plus complementary alternative medicine.|Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)|||Participants|||Number
720006|NCT00293293|Secondary|Average Natural Killer Cell Count Levels Before Chemotherapy and CAM|Natural killer cells are identified as CD3 (-), CD56(+) and CD16 (+). Phenotypic analysis and measurement of NK cells (NK cell count in mm^3 drawn before chemotherapy) using flow cytometry and specific mAb.|Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)|||Cells per mm^3||Full Range|Mean
720007|NCT00293293|Secondary|Average Natural Killer Cell Count Levels Before Chemotherapy Alone|Natural killer cells are identified as CD3 (-), CD56(+) and CD16 (+). Phenotypic analysis and measurement of NK cells (NK cell count in mm^3 drawn before chemotherapy) using flow cytometry and specific mAb.|Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)|||Cells per mm^3||Full Range|Mean
720009|NCT00293293|Secondary|Average Anti-Emetic Dose Use After Chemotherapy Alone|Determined by averaging the total dose of anti-emetic medications given (in milligrams) per patient.|Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)|||Dose (mg) per participant||Standard Deviation|Mean
720010|NCT00293293|Secondary|Average Number of Anti-Emetic Prescriptions Used After Chemotherapy + CAM|Determined by averaging the total number of anti-emetic prescriptions given per patient after chemotherapy and complementary alternative medicine.|Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)|Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).||Prescriptions per participant||Standard Deviation|Mean
720011|NCT00293293|Secondary|Average Number of Anti-Emetic Prescriptions Used After Chemotherapy Alone|Determined by averaging the total number of anti-emetic prescriptions given per patient after receiving chemotherapy.|Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)|Patients that received 6 cycles of chemotherapy alone.||Prescriptions per participant||Standard Deviation|Mean
720012|NCT00293293|Secondary|Number of Patients With Delays In Receiving Chemotherapy Plus CAM|Number of patients who had to delay their chemotherapy treatments and or complementary alternative medicine due to side effects.|Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)|||Participants|||Number
720013|NCT00293293|Secondary|Number of Patients With Delays In Receiving Chemotherapy Alone|Number of patients who had to delay their chemotherapy treatments due to side effects.|Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)|||participants|||Number
720014|NCT00293293|Primary|Comparison of Mental Health Inventory (MHI) Questionnaire Results - Average for Chemotherapy Alone vs. Chemotherapy Plus CAM|The MHI asks questions about how the consumer is feeling and coping with usual life activities. It provides measurable information about the consumer's wellbeing (anxiety, depression, loss of emotional control, general positive affect and emotional ties). A single score based on all items designed as high level summary index of the person's mental health status. High scores on the Mental Health Index indicate greater psychological well being and relatively less psychological distress (range is 38-240).|Prior to Cycle 1 (Day -2 to +1), Every 3rd cycle (1 cycle = approx 21 days) and 6 Months Post Chemotherapy|||Scores on a scale||Full Range|Mean
720015|NCT00293293|Primary|Quality of Life Comparison - Average FACT-O Scoring in Chemotherapy Alone vs. Chemotherapy Plus Complementary Alternative Medicine (CAM)|Measured by Functional Assessment of Cancer Therapy—Ovarian (FACT-O) questionnaire was used to assess patients' quality of life before each chemotherapy cycle. It is a standardized self-administered questionnaire measuring many aspects of quality of life (0 to 4; Not at all, A little bit, Some-what, Quite a bit, Very much) as related to patients with ovarian cancers. The quality of life measures include the total FACT-O score (minimum value 0, maximum value 200). Questionnaires are recoded in the final analysis phase so that a higher score reflected more adverse effects on quality of life.|Prior to Cycle 1 (Day -2 to +1), Every 3rd cycle (1 cycle = approx 21 days) and 6 Months Post Chemotherapy|||Scores on a Scale||Full Range|Mean
720016|NCT00293384|Secondary|Toxicity Grade 3, 4, or 5||at 0-120 hours|||participants|||Number
720017|NCT00293384|Other Pre-specified|Overall Nausea Controlled||at 0-120 hours|||participants|||Number
720018|NCT00293384|Secondary|Delayed Vomiting Controlled||at 25-120 hours|||participants|||Number
720019|NCT00293384|Primary|Proportion of Participants With Controlled Acute Vomiting|No episodes of vomiting and no rescue medication during first 24 hours after cyclophosphamide administration.|at 0-24 hours|Evaluable for response||participants|||Number
720020|NCT00293462|Secondary|Pain Questionnaire|Severity and quality of pain by questionnaires (0-10 with higher scores indicating more pain) at baseline, during radiotherapy, and once a month for 3 months after radiotherapy. Scores at all time points were averages together to compute one mean.|baseline through 3 months|Of the intent to treat population, subjects who did not fill out the baseline pain questionnaires were not included in our analysis. They withdrew from the study after signing the consent forms for personal reasons.||units on a scale||Standard Deviation|Mean
720021|NCT00293462|Secondary|Functional Status by Karnofsky Performance Status Scale|Functional status by Karnofsky Performance Status Scale (0-100 with higher scores indicating better functional status) at baseline, during radiotherapy, and once a month for 3 months after radiation therapy. Scores at all time points were combined to compute one mean.|baseline through 3 months|Of the intent to treat population, subjects who did not fill out the baseline Karnofsky functional scales were not included in our analysis. They withdrew from the study after signing the consent forms for personal reasons.||units on a scale||Standard Deviation|Mean
720022|NCT00293462|Secondary|Quality of Life During Radiation Therapy|Quality of life at baseline, during radiotherapy, and once a month for 3 months after radiotherapy. Quality of Life is measured with a scale that ranges from 0-10 with higher scores indicating a better quality of life. Scores at all time points were combined to compute one mean.|at baseline, during radiation therapy, and once a month for 3 months after radiation therapy|Of the intent to treat population, subjects who did not fill out the baseline quality of life questionnaires were not included in our analysis. They withdrew from the study after signing the consent forms for personal reasons.||units on a scale||Standard Deviation|Mean
720023|NCT00293462|Primary|Treatment Phase (Begins at Onset of Mucositis): Comparison of Three Groups to Evaluate the Effectiveness of the Two Mouthwashes.|To evaluate the effectiveness of the two mouthwashes in treating oral mucositis as defined by the incidence of Radiation Therapy Oncology Group Acute Radiation Morbidity Scoring. The number of days for mucositis to heal.|From onset of mucositis to healing of mucositis. Actual time variable. Mean: 95.8 days (SD 46.8)|Intent to treat population consisted of randomized subjects who completed baseline questionnaire and had at least one dose of mouthwash||Healing Days||Standard Error|Mean
720024|NCT00293462|Primary|Prevention Phase (Prior to Onset of Mucositis): Compare GG and SS Prior to Onset of Mucositis to Evaluate the Incidence of Radiation Therapy-induced Oral Mucositis|Incidence of grade 1 or 2 oral mucositis by Radiation Therapy Oncology Group Acute Radiation Morbidity Scoring Criteria Oral Mucosa Assessment Scale at baseline and during radiotherapy.|Prevention Phase (prior to onset of mucositis): Baseline to onset of mucositis. Actual time variable, mean time: 16.18 days (SD 7.4)|Intent to treat population consisted of randomized subjects who completed baseline questionnaire and had at least one dose of mouthwash||participants|||Number
720025|NCT00293540|Primary|Overall Survival|Assess whether patients who undergo surgical oophorectomy in the history-estimated mid-luteal phase of their menstrual cycles survive longer than patients who undergo this surgery in the history-estimated mid-follicular phase of their menstrual cycles.|Up to 9 years|Analyzed all patients with followup data||years||95% Confidence Interval|Median
720026|NCT00293579|Secondary|Overall Survival|Overall survival was measured from the time of initial study entry to death due to any cause.|Up to 2 years|All patients were deceased at the time of terminating this study.||months||Full Range|Median
720027|NCT00293579|Secondary|Impact of Pemetrexed Chemotherapy on Quality of Life|Quality of life assessements conducted at BL (baseline assessment) and EoT (End of treatment). University of Washington QOL (UW-QOL) questionnaire tests 9 specific areas relating to head and neck cancer. A composite score is calculated by adding together the 9 domain scores to give a scale from 0 (for poor health) to 900 (good health).|Baseline, End of Treatment [up to 3 years]|||Units on a scale||Standard Deviation|Mean
720028|NCT00293579|Secondary|Toxicities of Pemetrexed,in Poor Risk Cases With Poor Performance Status and Advanced, Metastatic, or Recurrent Head and Neck Cancer|Drug induced toxicities were assessed and graded according to the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|Up to 3 years|||percent of patients|||Number
720029|NCT00293579|Primary|Overall Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 3 years|||patients|||Number
720030|NCT00293709|Secondary|Change From Baseline in 12-Item Short Form Health Survey (SF-12) at Week 52|SF-12 questionnaire was used to determine participants’ quality of life (QoL). It comprised 12 items which covered 8 concepts : physical functionality, role impairment due to physical problems, physical pain, perception of general health, vitality, social functionality, role impairment due to emotional problems, and psychological wellbeing. Results were presented in the form of 2 meta-scores, the physical component and the mental component, each ranged from 0 to 100. Higher scores=better QoL, positive changes from baseline=improvement in QoL.|Baseline, Week 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.||units on a scale||Standard Deviation|Mean
720031|NCT00293709|Secondary|Change From Baseline in Patient Assessment of Pain at Week 52|Participants rated the severity of their psoriatic arthritis-related pain on a 0 (none) to 100 (most possible) scale.|Baseline, Week 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.||units on a scale||Standard Deviation|Mean
720032|NCT00293709|Secondary|Change From Baseline in Patient Assessment of Itching at Week 52|Participants rated the severity of their psoriasis itching on a 0 (none) to 100 (most possible) scale.|Baseline, Week 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.||units on a scale||Standard Deviation|Mean
720033|NCT00293709|Secondary|Change From Baseline in C-reactive Protein (CRP) at Week 52|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.||milligram per deciliter (mg/dL)||Standard Deviation|Mean
720034|NCT00293709|Secondary|Number of Participants With Nail Involvement|Number of participants with psoriatic arthritis affecting the nails are reported.|Baseline, Week 12, 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.||participants|||Number
720035|NCT00293709|Secondary|Change From Baseline in Physician Global Assessment of Disease Activity at Week 52|Physician global assessment of disease activity was measured on a 0 to 100 millimeter (mm) visual analog scale (VAS), with 0 mm = no disease activity to 100 mm = most possible disease activity.|Baseline, Week 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.||millimeter||Standard Deviation|Mean
720036|NCT00293709|Secondary|Change From Baseline in Ritchie Index at Week 52|Ritchie index: the numerical measurement of joint tenderness (28 joints) in participants with arthritis. The number of quantitative evaluations of the pain experienced by the participants when the joints were subjected to firm pressure when exerted over the articular margin or in some instances by passive movement of the joint. Participant’s reaction to pressure exerted by the physician were documented on 4-point scale, 0=not tender, 1=tender, 2=tender and caused wince, 3=reflexive effort to withdraw. Ritchie index was calculated as the total of the individual grades for all joints; ranged from 0 to 84, where higher score indicated higher tenderness.|Baseline, Week 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.||units on a scale||Standard Deviation|Mean
720056|NCT00294047|Secondary|Number of Subjects With First Colposcopy|Detection was done on all subjects irrespective of their baseline HPV DNA status.|Up to Month 84|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.||Subjects|||Number
720037|NCT00293709|Secondary|Change From Baseline in Disease Activity Score Based on 28 Joints Count (DAS 28) at Week 52|DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 100 mm; higher scores indicated greater affectation due to disease activity). DAS28 total score range: 0-10, where DAS28 less than or equal to (=<) 3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate disease activity and >5.1 = high disease activity.|Baseline, Week 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.||units on a scale||Standard Deviation|Mean
720038|NCT00293709|Secondary|Change From Baseline in Psoriasis Area and Severity Index (PASI) at Week 52|PASI: combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections (head, arms, trunk, and legs); each area was scored by itself and scores were combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90 – 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI=sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4; total score ranged from 0 (no disease) to 72 (maximal disease).|Baseline, Week 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.||units on a scale||Standard Deviation|Mean
720039|NCT00293709|Secondary|Change From Baseline in Percent Body Surface Area (BSA) Affected by Psoriasis at Week 52||Baseline, Week 52|Efficacy analysis set included all participants who were greater than (>) 18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.||percentage of BSA||Standard Deviation|Mean
720040|NCT00293709|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and Week 52 (end of the observation period) that were absent before treatment or that worsened relative to pretreatment state. AEs included SAEs as well as non-serious AEs which occurred during the trial.|Baseline up to Week 52|Safety analysis set included all participants who were enrolled in this study.||percentage of participants|||Number
720041|NCT00293722|Other Pre-specified|Change From Baseline in Patient Global Assessment of Disease Activity at Week 52|Measured using a 100 mm visual analog scale (VAS) ranging from 0 mm = very good to 100 mm = very bad.|Baseline, Week 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.||millimeter||Standard Deviation|Mean
720042|NCT00293722|Secondary|Change From Baseline in 12-Item Short Form Health Survey (SF-12) at Week 52|SF-12 questionnaire was used to determine participants’ quality of life (QoL). It comprised 12 items which covered 8 concepts: physical functionality, role impairment due to physical problems, physical pain, perception of general health, vitality, social functionality, role impairment due to emotional problems, and psychological wellbeing. Results were presented in the form of 2 meta-scores, the physical component and the mental component, each ranged from 0 to 100. Higher scores=better QoL, positive changes from baseline=improvement in QoL.|Baseline, Week 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.||units on a scale||Standard Deviation|Mean
720043|NCT00293722|Secondary|Change From Baseline in Patient Assessment of Pain at Week 52|Participants rated the severity of their psoriatic arthritis-related pain on a 0 (none) to 100 (most possible) scale.|Baseline, Week 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.||units on a scale||Standard Deviation|Mean
720044|NCT00293722|Secondary|Change From Baseline in Patient Assessment of Itching at Week 52|Participants rated the severity of their psoriasis itching on a 0 (none) to 100 (most possible) scale.|Baseline, Week 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.||units on a scale||Standard Deviation|Mean
720045|NCT00293722|Secondary|Change From Baseline in C-reactive Protein (CRP) at Week 52|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.||milligram per deciliter (mg/dL)||Standard Deviation|Mean
720057|NCT00294047|Secondary|Number of Subjects With Histopathologically Confirmed Reduction of Local Cervical Therapy|Detection was done on all subjects irrespective of their baseline HPV DNA status.|Up to Month 84|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.||Subjects|||Number
720046|NCT00293722|Secondary|Number of Participants With Nail Involvement|Number of participants with psoriatic arthritis affecting the nails are reported.|Baseline, Week 12, 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.||participants|||Number
720047|NCT00293722|Secondary|Change From Baseline in Physician Global Assessment of Disease Activity at Week 52|Physician global assessment of disease activity was measured on a 0 to 100 millimeter (mm) visual analog scale (VAS), with 0 mm = no disease activity to 100 mm = most possible disease activity.|Baseline, Week 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.||millimeter||Standard Deviation|Mean
720048|NCT00293722|Secondary|Change From Baseline in Ritchie Index at Week 52|Ritchie index: the numerical measurement of joint tenderness (28 joints) in participants with arthritis. The number of quantitative evaluations of the pain experienced by the participants when the joints were subjected to firm pressure when exerted over the articular margin or in some instances by passive movement of the joint. Participant’s reaction to pressure exerted by the physician were documented on 4-point scale, 0=not tender, 1=tender, 2=tender and caused wince, 3=reflexive effort to withdraw. Ritchie index was calculated as the total of the individual grades for all joints; ranged from 0 to 84, where higher score indicated higher tenderness.|Baseline, Week 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.||units on a scale||Standard Deviation|Mean
720049|NCT00293722|Secondary|Change From Baseline in Disease Activity Score Based on 28 Joints Count (DAS 28) at Week 52|DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 100 mm; higher scores indicated greater affectation due to disease activity). DAS28 total score range: 0-10, where DAS28 less than or equal to (=<) 3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate disease activity and >5.1 = high disease activity.|Baseline, Week 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.||units on a scale||Standard Deviation|Mean
720050|NCT00293722|Secondary|Change From Baseline in Percent Body Surface Area (BSA) Affected by Psoriasis at Week 52||Baseline, Week 52|Efficacy analysis set included all participants who were greater than (>) 18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.||percentage of BSA||Standard Deviation|Mean
720051|NCT00293722|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and Week 52 (end of the observation period) that were absent before treatment or that worsened relative to pretreatment state. AEs included SAEs as well as non-serious AEs which occurred during the trial.|Baseline up to Week 52|Safety analysis set included all participants who were enrolled in this study and had safety data available.||percentage of participants|||Number
720052|NCT00293813|Secondary|Cortical Thickness of Tibia by XtremeCT Percent Change From Baseline at Month 12|Cortical Thickness measured by XtremeCT.|12 months|||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
720053|NCT00293813|Primary|Cortical Thickness of Radius by XtremeCT Percent Change From Baseline at Month 12|Cortical Thickness measured by XtremeCT.|12 months|Randomized subjects who receive at least 1 dose of investigational product and have a baseline and at least 1 post baseline evaluation before or at month 12. Last Observation Carried Forward used as imputation method. Summarised for actual treatment taken.||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
720054|NCT00294047|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA).|Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. Detection was done on all subjects irrespective of their baseline HPV DNA and serostatus. The lesion was assigned to an HPV type found in the lesion if (1) the same HPV type was found in at least 1 of the 2 (closest) preceding cytology samples, or (2) none of the HPV types found in the lesion were found in any of the 2 preceding cytology samples (isolate HPV types)|Up to Month 84|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.||Subjects|||Number
720055|NCT00294047|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection|Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done on all subjects irrespective of their baseline HPV DNA and serostatus.|Up to Month 84|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.||Subjects|||Number
720058|NCT00294047|Secondary|Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations|Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Detection was done in subjects who were HPV DNA negative for the corresponding HPV type at baseline (at month 0 and Month 6) regardless of initial serostatus. HRW-HPV= All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HPV-HR= High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68|Up to Month 48|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.||Subjects|||Number
720059|NCT00294047|Secondary|Number of Subjects With Any Cytological Abnormalities Associated With HPV-16 or HPV-18 Cervical Infection|Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-US). Detection was done in: - DNA- and sero-: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative (sero-) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0). - Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline. Results for seropositive status were not analysed.|Up to Month 84|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.||Subjects|||Number
720060|NCT00294047|Secondary|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Irrespective of HPV Cervical Infection and Irrespective of Baseline HPV DNA Status|CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done on all subjects irrespective of their baseline HPV DNA status.|Up to Month 84|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.||Subjects|||Number
720061|NCT00294047|Secondary|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen||Up to Month 84|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.||Subjects|||Number
720062|NCT00294047|Secondary|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen|CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done in: - DNA- and sero-/+: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0). - Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.|Up to Month 84|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.||Subjects|||Number
720063|NCT00294047|Secondary|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen|CIN2+ was defined as CIN grades 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done in: - DNA- and sero-: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative (sero-) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0). - Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline. Note: Results for seropositive status were not analysed.|Up to Month 84|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.||Subjects|||Number
720064|NCT00294047|Secondary|Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations.|Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. subjects HPV DNA- for the corresponding HPV type at Month 0 6, regardless of initial serostatus. HPV-HRW=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HPV-HR=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 , 68|Up to Month 84|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.||Subjects|||Number
720065|NCT00294047|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations.|Persistent cervical HPV infection (6-month definition) = detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Detection was done in subjects HPV DNA- for the corresponding HPV type at baseline (at month 0 and Month 6) regardless of initial serostatus. HPV-HRW=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18. HPV-HR=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.|Up to Month 84|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.||Subjects|||Number
720109|NCT00294515|Secondary|Percentage of Patients Who Developed CMV Disease up to Month 18 Post-transplant|Percentage of CMV-seronegative renal transplant recipients (R-) receiving a CMV-seropositive graft (D+) who developed CMV disease (confirmed and assumed) within 18 months post-transplant.|18 months post-transplant|Intent-to-treat population||Percentage of patients||95% Confidence Interval|Mean
720066|NCT00294047|Secondary|Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18|Persistent cervical HPV infection (12-month definition) was defined as the detection of the same HPV type(s) PCR in cervical samples at all available time points over approximately a 12-month interval (evaluations are planned at approximately 6-month intervals). - DNA- and sero-/+: subjects HPV DNA negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by ELISA at baseline (Month 0). - Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.|Up to Month 84|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.||Subjects|||Number
720067|NCT00294047|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18|Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. Detection was done in: - DNA- and sero-/+: subjects HPV DNA negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by ELISA at baseline (Month 0). - Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.|Up to Month 84|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.||Subjects|||Number
720068|NCT00294047|Secondary|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the Type Assignment Algorithm (TAA)|"CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.
Detection was done on subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.
TAA: Type assignment algorithm. The lesion was assigned to an HPV type found in the lesion if
the same HPV type was found in at least one of the two (closest) preceding cytology samples, or
none of the HPV types found in the lesion were found in any of the two preceding cytology samples (isolate HPV types)"|Up to Month 48|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.||Subjects|||Number
720069|NCT00294047|Secondary|Number of Subjects With Pregnancies and Their Outcomes.|Pregnancy outcomes are live infant, premature live infant, elective termination, ectopic pregnancy, spontaneous abortion, lost to follow-up and pregnancy ongoing. For each category it was specified if the infant presents congenital anomaly (CA) or no apparent congenital anomaly (No ACA).|Up to Month 48|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.||Subjects|||Number
720070|NCT00294047|Secondary|Number of Subjects Reporting Medically Significant Conditions (MAEs).|Medically significant conditions were defined as: AEs prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.|Up to Month 48|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.||Subjects|||Number
720071|NCT00294047|Secondary|Number of Subjects Reporting New Onset of Autoimmune Disease (NOADs).||Up to Month 48|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.||Subjects|||Number
720072|NCT00294047|Secondary|Number of Subjects Reporting New Onset of Chronic Disease (NOCDs).|NOCDs include autoimmune disorders, asthma and type I diabetes.|Up to Month 48|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.||Subjects|||Number
720073|NCT00294047|Secondary|Number of Subjects Reporting Any AE/SAE Leading to Premature Discontinuation of the Study.|"An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity."|Up to Month 84|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.||Subjects|||Number
720074|NCT00294047|Secondary|Number of Subjects Reporting Related or Fatal Serious Adverse Event.|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Up to Month 84|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.||Subjects|||Number
720075|NCT00294047|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. A related SAE was defined as an event assessed by the investigator as causally related to the study vaccination.|Up to Month 48 and up to Month 84|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.||Subjects|||Number
720110|NCT00294515|Secondary|Percentage of Patients Who Developed CMV Disease up to Month 9 Post-transplant|Percentage of CMV-seronegative renal transplant recipients (R-) receiving a CMV-seropositive graft (D+) who developed CMV disease (confirmed and assumed) within 9 months post-transplant.|9 months post-transplant|Intent-to-treat population||Percentage of patients||95% Confidence Interval|Mean
720326|NCT00291577|Primary|Plasma Elimination Half-life (t1/2): Docetaxel PK Parameters|Mean Thalf (t1/2) = terminal elimination half life; collected C1D1, C2D1. Paired observation.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose|Evaluable set of subjects for PK analysis||hours||Standard Deviation|Mean
720076|NCT00294047|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|"An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Grade 3 unsolicited AE = an event that prevented normal activity.
A related AE = event assessed by the investigator as causally related to the study vaccination."|Within 30 days (Days 0 – 29) post-vaccination period.|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.||Subjects|||Number
720077|NCT00294047|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, urticaria and fever (Fever = axillary temperature above 37.5 degrees Celsius (°C)). Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 urticaria = urticaria distributed on at least 4 body areas. Grade 3 fever = axillary temperature above 39.0°C.|Within 7 days (Days 0-6) after vaccination|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented and symptom sheets completed.||Subjects|||Number
720078|NCT00294047|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling was defined as redness/swelling above 50 millimeter (mm).|Within 7 days (Days 0-6) after vaccination|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented and symptom sheets completed.||Subjects|||Number
720079|NCT00294047|Secondary|Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects.|"Titers are expressed as geometric mean antibody titers (GMTs).
Seronegative (Sero-) subjects are subjects who had an antibody titer below 40 ED50 prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody titer equal to or above 40 ED50 prior to vaccination.
ED50 = Estimated dose 50%, the estimated serum dilution reducing the signal generated by viral infection by 50%"|Prior to vaccination and at Months 7, 12, 18, 24, 48 and 84.|The According-To-Protocol cohort for immunogenicity included subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. The 15% subset of women enrolled with prior history of HPV disease/infection was included.||Titers||95% Confidence Interval|Geometric Mean
720080|NCT00294047|Secondary|Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects.|Seroconversion was defined as the appearance of antibodies (i.e.; titre greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. HPV-16/18 assay cut-off value was defined as greater than or equal to 40 Estimated dose 50% (ED50). Sero- subjects are subjects who had an antibody concentration below 40 ED50 prior to vaccination. Sero+ subjects are subjects who had an antibody concentration equal to or above 50 ED50 prior to vaccination. ED50 = the estimated serum dilution reducing the signal generated by viral infection by 50%|Prior to vaccination and at Months 7, 12, 18, 24, 48 and 84.|The According-To-Protocol cohort for immunogenicity included subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. The 15% subset of women enrolled with prior history of HPV disease/infection was included.||Subjects|||Number
720081|NCT00294047|Secondary|Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset.|"GMCs were expressed in ELISA units per milliliter (EL.U/mL).
Seronegative (Sero-) subjects are subjects who had an antibody concentration below 7 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration equal to or above 7 EL.U/mL prior to vaccination.
Immuno subset=subjects from selected sites (N≥1000, at least 250 per region)"|At pre-vaccination and at Month 7, 12, 18, 24, 36, 48, 60, 72 and 84|The According-To-Protocol cohort for immunogenicity included subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. The 15% subset of women enrolled with prior history of HPV disease/infection was included.||EL.U/mL||95% Confidence Interval|Geometric Mean
720082|NCT00294047|Secondary|Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset.|"GMCs were expressed in ELISA units per milliliter (EL.U/mL).
Seronegative (Sero-) subjects are subjects who had an antibody concentration below 8 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration equal to or above 8 EL.U/mL prior to vaccination.
Immuno subset=subjects from selected sites (N≥1000, at least 250 per region)"|At pre-vaccination and at Month 7, 12, 18, 24, 36, 48, 60, 72 and 84|The According-To-Protocol cohort for immunogenicity included subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. The 15% subset of women enrolled with prior history of HPV disease/infection was included.||EL.U/mL||95% Confidence Interval|Geometric Mean
720083|NCT00294047|Secondary|Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset.|"Seroconversion was defined as the appearance of antibodies (i.e.; titre greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.
HPV-18 assay cut-off value was defined as greater than or equal to 7 ELISA units per millilitre (EL.U/mL). Seronegative (Sero-) subjects are subjects who had an antibody concentration below 7 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration equal to or above 7 EL.U/mL prior to vaccination.
Immuno subset=subjects from selected sites N≥1000, at least 250 per region"|At pre-vaccination and at Month 7, 12, 18, 24, 36, 48, 60, 72 and 84|The According-To-Protocol cohort for immunogenicity included subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. The 15% subset of women enrolled with prior history of HPV disease/infection was included.||Subjects|||Number
720922|NCT00304070|Secondary|Frequency of Tumor Spillage at the Time of Tumor Resection|The number of eligible patients who have surgical resection of the primary tumor and have tumor spillage at the time of resection.|Up to one year or while on protocol therapy, whichever is less|||Participants|||Count of Participants
720084|NCT00294047|Secondary|Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset.|"Seroconversion was defined as the appearance of antibodies (i.e.; titre greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.
HPV-16 assay cut-off value was defined as greater than or equal to 8 ELISA units per millilitre (EL.U/mL). Seronegative (Sero-) subjects are subjects who had an antibody concentration below 8 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration equal to or above 8 EL.U/mL prior to vaccination.
Immuno subset=subjects from selected sites N≥1000, at least 250 per region"|At pre-vaccination and at Month 7, 12, 18, 24, 36, 48, 60, 72 and 84|The According-To-Protocol cohort for immunogenicity included subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. The 15% subset of women enrolled with prior history of HPV disease/infection was included.||Subjects|||Number
720085|NCT00294047|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA).|"Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval.
Detection was done on all subjects irrespective of their baseline HPV DNA and serostatus.
The lesion was assigned to an HPV type found in the lesion if (1) the same HPV type was found in at least 1 of the 2 (closest) preceding cytology samples, or (2) none of the HPV types found in the lesion were found in any of the 2 preceding cytology samples (isolate HPV types)"|Up to Month 48|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.||Subjects|||Number
720086|NCT00294047|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection|"Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval.
CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.
Detection was done on all subjects irrespective of their baseline HPV DNA and serostatus."|Up to Month 48|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.||Subjects|||Number
720087|NCT00294047|Secondary|Number of Subjects With First Colposcopy|Detection was done on all subjects irrespective of their baseline HPV DNA status.|Up to Month 48|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.||Subjects|||Number
720088|NCT00294047|Secondary|Number of Subjects With Histopathologically Confirmed Reduction of Local Cervical Therapy|Detection was done on all subjects irrespective of their baseline HPV DNA status.|Up to Month 48|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.||Subjects|||Number
720089|NCT00294047|Secondary|Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations|"Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Detection was done in subjects who were HPV DNA negative for the corresponding HPV type at baseline (at month 0 and Month 6) regardless of initial serostatus.
HRW-HPV= All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HPV-HR= High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68"|Up to Month 48|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.||Subjects|||Number
720090|NCT00294047|Secondary|Number of Subjects With Any Cytological Abnormalities Associated With HPV-16 or HPV-18 Cervical Infection|"Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-US).
Detection was done in:
DNA- and sero-: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative (sero-) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0).
Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.
Results for seropositive status were not analysed."|Up to Month 48|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.||Subjects|||Number
720091|NCT00294047|Secondary|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Irrespective of HPV Cervical Infection and Irrespective of Baseline HPV DNA Status|"CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.
Detection was done on all subjects irrespective of their baseline HPV DNA status."|Up to Month 48|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.||Subjects|||Number
720092|NCT00294047|Secondary|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.
Detection was done on all subjects irrespective of their baseline HPV DNA and serostatus."|Up to Month 48|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.||Subjects|||Number
720111|NCT00294515|Secondary|Percentage of Patients Who Developed CMV Disease up to Month 6 Post-transplant|Percentage of CMV-seronegative renal transplant recipients (R-) receiving a CMV-seropositive graft (D+) who developed CMV disease (confirmed and assumed) within 6 months post-transplant.|6 months post-transplant|Intent-to-treat population||Percentage of patients||95% Confidence Interval|Mean
720112|NCT00294515|Primary|Percentage of Patients Who Developed Cytomegalovirus (CMV) Disease up to Month 12 Post-transplant|Percentage of CMV-seronegative renal transplant recipients (R-) receiving a CMV-seropositive graft (D+) who developed CMV disease (confirmed and assumed) within 12 months post-transplant.|12 months post-transplant|Intent-to-treat population||Percentage of patients||95% Confidence Interval|Mean
720093|NCT00294047|Secondary|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.
Detection was done in:
DNA- and sero-/+: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0).
Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline."|Up to Month 48|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.||Subjects|||Number
720094|NCT00294047|Secondary|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN2+ was defined as CIN grades 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.
Detection was done in:
DNA- and sero-: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative (sero-) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0).
Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.
Note: Results for seropositive status were not analysed."|Up to Month 48|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.||Subjects|||Number
720095|NCT00294047|Secondary|Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations.|"Persistent HPV infection (12-month definition) = detection of the same HPV type(s) by PCR in cervical samples at available time points over approximately a 12-month interval (evaluations are planned at approximately 6-month intervals).
Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
subjects HPV DNA- for the corresponding HPV type at Month 0 6, regardless of initial serostatus.
HPV-HRW=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HPV-HR=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 , 68"|Up to Month 48|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.||Subjects|||Number
720096|NCT00294047|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations.|"Persistent cervical HPV infection (6-month definition) = detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval.
Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Detection was done in subjects HPV DNA- for the corresponding HPV type at baseline (at month 0 and Month 6) regardless of initial serostatus.
HPV-HRW=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18. HPV-HR=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68."|Up to Month 48|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.||Subjects|||Number
720097|NCT00294047|Secondary|Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18|"Persistent cervical HPV infection (12-month definition) was defined as the detection of the same HPV type(s) PCR in cervical samples at all available time points over approximately a 12-month interval (evaluations are planned at approximately 6-month intervals).
DNA- and sero-/+: subjects HPV DNA negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by ELISA at baseline (Month 0).
Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline."|Up to Month 48|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.||Subjects|||Number
720098|NCT00294047|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18|"Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval.
Detection was done in:
DNA- and sero-/+: subjects HPV DNA negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by ELISA at baseline (Month 0).
Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline."|Up to Month 48|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.||Subjects|||Number
720113|NCT00300742|Primary|Compliance With Study Requirements: Topiramate Level|Number of subjects who escalated to the maximum dose of 300 mg of topiramate/day|up to 12 weeks|This is the number of participants who reached the dose of 300 mg of topiramate||participants|||Number
720114|NCT00300742|Primary|Mean Binge Eating Episodes Per Week at Baseline vs. Visit 12|Mean binge eating episodes per week at baseline vs. Visit 12 measured by self report on timeline follow-back (TLFB) calendars in conjunction with the subject's daily diary|up to 24 weeks|Per protocol||Binge eating episodes/week||Standard Deviation|Mean
720115|NCT00300742|Primary|Mean Percent Days Abstinent Per Week at Baseline vs. Visit 12|Mean percent days abstinent per week at baseline vs. Visit 12 measured by self report on timeline follow-back (TLFB) calendars in conjunction with the subject's daily diary|up to 24 weeks|Per protocol||Mean percent days abstinent per week||Standard Deviation|Mean
720099|NCT00294047|Primary|Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA).|CIN1+ = CIN grades 1, 2 and 3, AIS and invasive cervical cancer. Persistent cervical HPV infection (6-month definition) = detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. - DNA- and sero-/+: subjects HPV DNA negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by ELISA at baseline (Month 0). - Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.|Up to Month 84|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.||Subjects|||Number
720100|NCT00294047|Primary|Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection.|CIN1+ = CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Persistent HPV infection = detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. - DNA- and sero-/+: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and 6 and seronegative/positive (sero-/+) at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA) - Overall: subjects DNA- at Month 0 and 6 for the corresponding HPV-type, regardless of initial serostatus|Up to Month 84|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.||Subjects|||Number
720101|NCT00294047|Primary|Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA).|"CIN1+ = CIN grades 1, 2 and 3, AIS and invasive cervical cancer. Persistent cervical HPV infection (6-month definition) = detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval.
DNA- and sero-/+: subjects HPV DNA negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by ELISA at baseline (Month 0).
Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline."|Up to Month 48|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.||Subjects|||Number
720102|NCT00294047|Primary|Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection.|"CIN1+ = CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.
Persistent HPV infection = detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval.
DNA- and sero-/+: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and 6 and seronegative/positive (sero-/+) at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA)
Overall: subjects DNA- at Month 0 and 6 for the corresponding HPV-type, regardless of initial serostatus"|Up to Month 48|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.||Subjects|||Number
720103|NCT00294060|Primary|Multiple In-clinic Visits|Follow-up practice pattern assessed by the number of patients with a dual chamber device that had two or more routine pacemaker in-clinic visits with a device interrogation|implant to one year|Only those patients with a dual chamber device completing 12 months of follow-up were included in this analysis.||participants with 2 or more visits|||Number
720104|NCT00294060|Primary|Days Hospitalized|Healthcare utilization clinical outcome characterized by number of days hospitalized in the first year|implant to one year|Patients with a twelve-month follow-up visit were included in the analysis.||average days hospitalized||Standard Deviation|Mean
720105|NCT00294060|Primary|Number of Participants With Dual Chamber Devices|Pacemaker device choice characterized by the number of patients with dual chamber devices|at original implant|||Participants with dual chamber devices|||Number
720106|NCT00294398|Secondary|Asthma-related Quality of Life|Bukstein health-related quality of life instrument is an an 8-item questionnaire for measuring health-related quality of life in pediatric asthma. The daytime and nighttime symptom scales for each contain 2 items and the functional limitations scale 4 items. Prior validation studies confirm each scale's ability to detect changes at both low and high levels of functioning. The scale is scored from 0 to 100, with higher scores indicating better quality of life and lower scores translate to poorer health-related quality of life.|2 months|Analysis population was based on the intention to treat number at enrollment.||units on a scale||Standard Deviation|Mean
720107|NCT00294398|Primary|Number of Inhaled Corticosteroid (ICS) Prescriptions Refilled (Confirmed by Primary Care Physician)|Verification of a filled prescription for an ICS was completed 2 months after emergency department (ED) visit via telephone call to the pharmacy. Individual informed consent forms were faxed to the pharmacy to obtain verification that a prescription was filled. The number of subjects who filled a prescription for an ICS after the ED visit was compared between the two groups.|2 months|Analysis population was based on the intention to treat number at enrollment.||Participants|||Number
720108|NCT00294515|Secondary|Percentage of Patients Who Developed CMV Disease up to Month 24 Post-transplant|Percentage of CMV-seronegative renal transplant recipients (R-) receiving a CMV-seropositive graft (D+) who developed CMV disease (confirmed and assumed) within 24 months post-transplant.|24 months post-transplant|Intent-to-treat population||Percentage of patients||95% Confidence Interval|Mean
720118|NCT00300755|Secondary|"Number of Patients With Healed Erosive Esophagitis (EE) at End of Study"|Healed EE was defined as a modified Hetzel-Dent (HD) score <2 on endoscopy at end of study. HD is a standardized rating scale for grading esophageal damage and severity of gastroesophageal reflux disease (GERD). HD score ranges from 0 (normal mucosa) to 4 (deep peptic ulceration).|8 weeks|The analysis population is randomized patients with erosive esophagitis at baseline.||patients|||Number
720119|NCT00300755|Secondary|Change in Individual Weekly Mean Score For Each Respiratory Symptom From Baseline|Individual respiratory symptoms weekly score was calculated as the average score / number of events for a patient in the corresponding week if the patient answered a question ≥3 times that week. Change = final week score minus baseline score. Final week was defined as the last 7 days of scores collected in the treatment period.|Baseline and 8 weeks|The analysis population is all patients who were randomized and received ≥1 dose of test article and had nonerosive gastroesophageal reflux disease. Data were excluded if a patient answered a question <3 times in a week.||units on scale||Standard Deviation|Mean
720120|NCT00300755|Secondary|Change in Individual Weekly Mean Frequency Score for Each Gastroesophageal Reflux Disease (GERD) Symptom Score From Baseline to Final Week|Selected symptoms of GERD were assessed using a parent-administered questionnaire. The score for each symptom ranged from 0 (no symptom) to 3 (highest frequency of symptom), The weekly mean score was the sum of daily scores that week, divided by the number of days with scores for that week. Change = final week score minus baseline score. Final week was defined as the last 7 days of scores collected in the treatment period.|Baseline and 8 weeks|The analysis population is all patients who were randomized and received ≥1 dose of test article and had nonerosive gastroesophageal reflux disease.||units on scale||Standard Deviation|Mean
720121|NCT00300755|Primary|Change in Weekly Gastroesophageal Reflux Disease (GERD) Symptom Scores (WGSS)|WGSS is the sum of 5 selected individual weekly GERD mean frequency scores: vomiting/regurgitation, choking/gagging, refusal to eat, difficulty swallowing and abdominal/belly pain. Symptoms were assessed using a parent-administered questionnaire. The score for each individual symptom ranged from 0 (no symptoms) to 3 (highest frequency of symptoms), giving a WGSS range of 0-15. Change = score at week of assessment minus baseline score. Final week was defined as the last 7 days of symptom scores collected in the treatment period.|Baseline and 8 weeks|The primary efficacy population (mITT NERD) included all patients who were randomized and received ≥1 dose of test article and had nonerosive gastroesophageal reflux disease. Last observation carried forward (except for baseline data, which were not carried forward into the treatment period).||units on scale||Standard Deviation|Mean
720122|NCT00300781|Secondary|Duration of Response|The duration of response is measured from the time criteria are met for CR or PR until the first date of PD or death|From start date of response to first PD/death|Subjects in ITT population with CR or PR||weeks||95% Confidence Interval|Median
720123|NCT00300781|Secondary|Clinical Benefit Rate|Clinical benefit rate (CR, PR, or SD ≥ 24 weeks) by independent assessment|From first dose date to progression or last tumor assessment|ITT population||percentage of participants||95% Confidence Interval|Number
720124|NCT00300781|Secondary|Objective Response Rate|Objective response rate of PR or CR by independent assessment of tumor|From first dose date to progression or last tumor assessment|ITT population||percentage of participants||95% Confidence Interval|Number
720125|NCT00300781|Primary|16-week Progression Free Survival|16 week progression-free survival (PFS) rate of neratinib in women with Her2+ b.c., either with prior Herceptin or no prior Herceptin therapy, evaluated by independent assessment of tumor scans collected at baseline and then every 8 weeks.|From first dose to 16 weeks|ITT Population||percentage of participants||95% Confidence Interval|Number
720126|NCT00300885|Secondary|Patient Reported Outcome as Assessed by LCS Subscale Score. Change From Baseline in LCS Subscale at Cycles 2 Through 9 and at End of Treatment (EOT)|Lung Cancer Symptoms (LCS) subscale ranges from 0 (severe debilitation) to 28 (asymptomatic). Cycle duration defined as 21 days. Change from baseline in LCS Subscale on day 1 of cycles 2 through 9 (weeks 4,7,10,13,16,19,22 and 25) and end of treatment (EOT); cycle 1, day 1 used as baseline. EOT is determined by patient's last visit after treatment discontinuation.|Outcome measure was assessed on Day 1 of Cycle 1 and Day 1 of every cycle (i.e. Cycle 2, 3, 4, 5 etc.) during treatment and at end of treatment visit or up to data cutoff (10ct2007) used for planned formal interim analysis|Evaluations of LCS Subscale based on the ITT population.||Scores on a scale||Standard Deviation|Mean
720127|NCT00300885|Secondary|Patient Reported Outcome as Assessed by FACT-L Score. Change From Baseline in Total FACT-L at Cycles 3,5,7,9 and End of Treatment (EOT)|"Functional Assessment of Cancer Therapy - Lung cancer subscore (FACT-L). Patient reported outcome as assessed by FACT-L score. FACT-L questionnaire comprises statements about physical, social / family, emotional and functional well-being as well as additional concerns which have to be rated by the patients (0=not at all to 4=very much). Cycle duration defined as 21 days. Change from baseline in Total FACT-L on day 1 of cycles 3,5,7,9 (weeks 7,13,19 and 25) and end of treatment (EOT); cycle 1, day 1 used as baseline. EOT is determined by patient's last visit after treatment discontinuation."|Outcome measure was assessed on Day 1 of Cycle 1 and Day 1 of every other cycle (i.e. Cycle 3, 5, 7 etc.) during treatment and at end of treatment visit or up to data cutoff (10ct2007) used for planned formal interim analysis|Evaluations of Total FACT-L based on the ITT population.||Scores on a scale||Standard Deviation|Mean
720128|NCT00300885|Secondary|Duration of Response|Duration of response (PR or better) is defined as the time from the first documented objective response of PR or CR, whichever is noted earlier, to disease progression or death (if death occurs before progression is documented).|Tumor measurements and assessments based on RECIST criteria were performed every 6 weeks for the first 18 weeks of therapy ( week 6, 12, and 18) and every 12 weeks thereafter up to data cutoff (1Oct2007) used for planned formal interim analysis|Evaluations of duration of response based on the ITT population.||days||95% Confidence Interval|Median
720129|NCT00300885|Secondary|Overall Best Response|Best overall tumor response for the ITT population was determined according to Response Evaluation Criteria in Solid Tumors (RECIST). Categories: complete response (CR, tumor disappears), partial response (PR, sum of lesion sizes decreased), stable disease (SD, steady state of disease), progressive disease (PD, sum of lesion sizes increased).|Tumor measurements and assessments based on RECIST criteria were performed every 6 weeks for the first 18 weeks of therapy ( week 6, 12, and 18) and every 12 weeks thereafter up to data cutoff (1Oct2007) used for planned formal interim analysis|Evaluations of overall best response rate based on the ITT population.||percentage of participants|||Number
720130|NCT00300885|Secondary|Progression Free Survival (PFS)|PFS determined as time (days) from the date of randomization at start of study to disease progression (radiological or clinical) or death due to any cause, if death occurs before progression.|Tumor measurements and assessments based on RECIST criteria were performed every 6 weeks for the first 18 weeks of therapy ( week 6, 12, and 18) and every 12 weeks thereafter up to data cutoff (1Oct2007) used for planned formal interim analysis|PFS (based on the ITT population) for subjects without disease progression/death at the time of analysis were censored at the last evaluation date. PFS for surviving subjects without post-baseline tumor assessments were censored at one day. In the case of an incomplete date (missing day), day 15 (the middle of the month) will be used.||days||95% Confidence Interval|Median
720131|NCT00300885|Primary|Overall Survival (OS) in Patients Treated With Carboplatin, Paclitaxel and Sorafenib to OS in Patients Treated With Carboplatin, Paclitaxel and Placebo|Overall survival determined as the time (days) from the date of randomization at start of study to the date of death, due to any cause. Outcome measure was assessed regularly, i.e. every 3 weeks during study treatment and every 3 months during post-treatment.|Outcome measure was assessed every 3 weeks starting from randomization, during treatment period and every 3 months during follow-up period until death was recorded or up to data cutoff (1Oct2007) used for planned formal interim analysis|Evaluations of OS based on the ITT population. Subjects alive at the time of analysis were censored at their last date of follow-up (last visit or contact or at the data cut-off date). In the case of an incomplete date, if the day is missing, day 15 (the middle of the month) will be used.||days||95% Confidence Interval|Median
720132|NCT00301028|Primary|Number of Participants With Complete Response|Number of participants with a complete response. Complete Response (CR): Disappearance of clinical and radiological evidence of tumor.|Study period of 3 Years|||participants|||Number
720133|NCT00304161|Secondary|Clinical Global Impression-Improvement Scale|"The Clinical Global Impression-Improvement scale rates total improvement on a 7 point scale:
= Very much improved
= Much improved
= Minimally improved
= No change
= Minimally worse
= Much worse
= Very much worse
A participant scoring a 1 or 2 is considered a responder on the CGI scale."|Week 8|||percentage of responders|||Number
720134|NCT00304161|Primary|Inventory of Depressive Symptomatology- Clinician Rated (IDS-C) Scale|The primary measure of depression symptom severity was the Inventory for Depressive Symptomatology–Clinician Rated (IDS-C), a 30-item (scores 0–84, increasing scores indicating greater depression severity) comprehensive instrument that is increasingly used as a primary outcome measure in major depression treatment studies in the general population. An IDS-C score of greater than or equal to 22 was indicative of at least moderate depression. The IDS-C was administered at every study visit. The criteria for the primary measure of treatment response was a >50% decrease in IDS-C score from baseline.|Week 8|||percentage of improved participants|||Number
720137|NCT00304265|Primary|Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine|"Solicited injection site reactions: Pain, Erythema, Swelling, and Arm circumference.
Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia."|Days 0 to 14 Post-vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.||Participants|||Number
720138|NCT00304278|Secondary|Survival Post Treatment|Overall Survival with a minimum follow up of 1year. Relapse/Persistent Disease Rates|22 months|||participants|||Number
720139|NCT00304278|Primary|Number of Participants With Complete and Partial Response Using RECIST Criteria|Complete and Partial Response as defined by RECIST 1.0. Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD|17 weeks|||Participants|||Count of Participants
720140|NCT00304707|Primary|Smoking Abstinence|The number of subjects in each treatment group who were smoking abstinent (7-day point prevalence) at week 7 (end of treatment), week 11 and week 24.|week 7, week 11 and week 24 after scheduled quit day|||participants|||Number
720141|NCT00304746|Primary|21-item Hamilton Depression Rating Scale Score (HAM-D)|The HAM-D generates a score ranging from 0 (no depressive symptoms) to 64 (most severe depression).|9 weeks (1-week placebo lead-in and 8 weeks of blinded medication treatment)|All of the 100 randomized participants are included in the Last Observation Carried Forward (LOCF) analysis presented here online, which provides the mean and SD of this outcome measure for each study arm. Full details of all analyses are provided in the published paper presenting the results of the study.||units on a scale||Standard Deviation|Mean
720142|NCT00304746|Secondary|Montgomery Asberg Depression Rating Scale (MADRS)|The Montgomery Asberg Depression Rating Scale (MADRS) is a clinician-assessed scale that rates depressive symptoms on a scale from 0 (no depressive symptoms) to 60 (maximal depressive symptoms).|9 weeks (1 week of placebo lead-in and 8 weeks of blinded medication treatment)|All of the 100 randomized participants are included in the Last Observation Carried Forward (LOCF) analysis presented here online, which provides the mean and SD of this outcome measure for each study arm. Full details of all analyses are provided in the published paper presenting the results of the study.||units on a scale||Standard Deviation|Mean
720143|NCT00304915|Primary|Percentage of Participants With Depression Treatment Response|Depression symptom severity over the past two weeks was measured using the Hopkins Symptom Checklist (SCL-20). The SCL-20 includes the 13-item depression scale plus 7 depression-related items from the Hopkins Symptom Checklist-90-Revised. The items are scored from 0 to 4 and averaged to provide a mean depression severity score from 0 to 4. Depression treatment response at 6-months was defined as a 50% decrease in mean SCL-20 score compared to baseline.|6 months|intent to treat analysis||percent response|||Number
720144|NCT00304954|Secondary|Changes in Retinal Thickness as Measured by Optical Coherence Tomography (OCT) From Baseline to 24 Weeks||Baseline and 6 months (24 weeks) - Baseline and 3.5 months for Patient 7|||Microns|||Number
721022|NCT00317941|Secondary|Mean Pain Assessment Using Visual Analogue Scale (VAS) Reported by Participants 30 Minutes After Injection|Visual analogue scale was used to report the pain from 0 (no pain ) to 10 (maximal pain).|30 min after injection|||Scores on a scale||Full Range|Mean
720145|NCT00304954|Secondary|Changes in Best-corrected Visual Acuity (BCVA) as Measured by the Standard Early Treatment Diabetic Retinopathy Study (ETDRS) Protocol From Baseline to 24 Weeks|"The values in the table represent the denominator for the visual acuity in feet. A value of 20 represents normal 20/20 vision while increasing values for the denominator represent worsening vision."|Baseline and 6 months (24 weeks) - Baseline and 3.5 months for Patient 7|||Feet|||Number
720146|NCT00304954|Primary|Monthly Rates of Anti-VEGF (Vascular Endothelial Growth Factor) Injections||24 Weeks|||Injections per Month||Full Range|Median
720147|NCT00305162|Secondary|Incidence of ACUITY Major Bleeding (Without Hematoma >/= 5 cm)|excludes ACUITY major bleeding for which the only qualifying event was hematoma >/= 5 cm|randomization through 48 hours after randomization|Safety Population (inclusive of STEMI patients)||participants|||Number
720148|NCT00305162|Secondary|Incidence of ACUITY Major Bleeding|Major bleeding (non-CABG-related) - Safety population|randomization through 48 hours after randomization|Safety Population (inclusive of STEMI patients)||participants|||Number
720149|NCT00305162|Secondary|Incidence of Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding|Major bleeding (non-CABG-related) - Safety population|randomization through 48 hours after randomization|Safety Population (inclusive of STEMI patients)||participants|||Number
720150|NCT00305162|Secondary|Incidence of GUSTO Severe / Life-threatening Bleeding|Major bleeding (non-CABG-related) - Safety population|randomization through 48 hours after randomization|Safety Population (inclusive of STEMI patients)||participants|||Number
720151|NCT00305162|Secondary|Incidence of All Cause Mortality|(excluding STEMI)|randomization through 1 year after randomization|mITT (excluding STEMI), based on 1 year completers||participants|||Number
720152|NCT00305162|Secondary|Incidence of Stroke||randomization through 30 days after randomization|mITT (excluding STEMI), based on available data||participants|||Number
720153|NCT00305162|Secondary|Incidence of IDR||randomization through 30 days after randomization|mITT (excluding STEMI), based on 30-day completers||participants|||Number
720154|NCT00305162|Secondary|Incidence of MI||randomization through 30 days after randomization|mITT (excluding STEMI), based on 30-day completers||participants|||Number
720155|NCT00305162|Secondary|Incidence of All-cause Mortality||randomization through 30 days after randomization|mITT (excluding STEMI), based on 30-day completers||participants|||Number
720156|NCT00305162|Secondary|Incidence of All-cause Mortality or MI|(composite incidence)|randomization through 30 days after randomization|mITT (excluding STEMI), based on 30-day completers||participants|||Number
720157|NCT00305162|Secondary|Incidence of All-cause Mortality, MI or IDR|(composite incidence)|randomization through 30 days after randomization|mITT (excluding STEMI), based on 30-day completers||participants|||Number
720158|NCT00305162|Secondary|Incidence of Abrupt Closure, Threatened Abrupt Closure, Need for Urgent Coronary Artery Bypass Graft (CABG) Surgery, or Unsuccessful Procedure During the Index PCI|(a patient could have multiple procedural events)|during index PCI|mITT (excluding STEMI) and based on available data||participants|||Number
720159|NCT00305162|Secondary|Incidence of Stroke|"Stroke is defined as a sudden, focal neurological defect resulting from a cerebrovascular cause that is not reversible within 24 hours and not due to a readily identifiable cause such as a tumor or trauma. All suspected strokes were reviewed and adjudicated by the Clinical Events Committee (CEC) who considered all clinically relevant information and imaging studies to classify all strokes as:
primary hemorrhagic - stroke with focal collections of intracranial blood
ischemic cerebral infarction - stroke without focal collections of intracranial blood
infarction with hemorrhagic conversion - cerebral infarction with blood thought to represent hemorrhagic conversion and not primary bleeding
uncertain - no imaging or autopsy data are available."|randomization through 48 hours after randomization|mITT (excluding STEMI)||participants|||Number
720160|NCT00305162|Secondary|Individual Incidence of IDR||randomization through 48 hours after randomization|mITT (excluding STEMI)||participants|||Number
720161|NCT00305162|Secondary|Individual Incidence of All-cause Mortality||randomization through 48 hours after randomization|mITT (excluding STEMI)||participants|||Number
720162|NCT00305162|Secondary|Incidence of All-cause Mortality and MI|(composite incidence)|randomization through 48 hours after randomization|mITT (excluding STEMI)||participants|||Number
720163|NCT00305162|Primary|Incidence of All-cause Mortality, Myocardial Infarction (MI), and Ischemia-driven Revascularization (IDR)|(composite incidence)|randomization through 48 hours after randomization|mITT (excluding STEMI)||participants|||Number
720164|NCT00305227|Secondary|Incidence of Vaginal Discharge||4 mo||||||
720165|NCT00305227|Primary|Incidence of Urinary Tract Infection|Recurrent urinary tract infection after initiation of intervention. Culture-confirmed to contain uropathogen.|10 weeks|The reported analysis was by intention to treat. All study participants were used, except for 4 participants in whom the major outcome measure was unevaluable.||participants|||Number
720166|NCT00305253|Secondary|Emergency Hysterectomy|incidence of emergency hysterectomy for cases of uterine atony|within 72 hours of study enrollment|Data on emergency hysterectomy are only for women with diagnosis of uterine atony.||participants|||Number
720167|NCT00305253|Secondary|Blood Loss Due to Obstetric Hemorrhage|cumulative blood loss measured hourly upon study admission by calibrated blood collection drape|within 72 hours of study enrollment|Blood loss information was missing on some patients.||mL||Standard Deviation|Mean
720168|NCT00305253|Primary|Extreme Adverse Outcomes (EAO) - a Combined Outcome of Maternal Mortality or Severe Morbidity (Cardiac,Respiratory, Renal or Cerebral Dysfunction)||from early pregnancy to within 3 weeks postpartum|All patients enrolled in the study were used in this analysis.||participants|||Number
720169|NCT00305344|Primary|Children With T1D Underwent a Single Autologous UCB Transfusion|All participants were monitored for 2 years. Baseline and post-infusion mixed meal tolerance tests were performed to determine whether autologous cord blood infusion preserved endogenous insulin production. The change in median area under the curve for C-peptide (measure of insuln production) from baseline to to 2 years during a 2 hour mixed meal tolerance test was used as the primary outcome measure and was reported in ng/ml/120 minutes|Baseline to Year 2|All participants received their own autologous umbilical cord blood (UCB)||ng /ml /120 min||Inter-Quartile Range|Median
720370|NCT00297427|Primary|Incontinence-Specific Quality of Life|Percent change in incontinence-specific quality of life a 4 weeks post-intervention (true or sham acupuncture) measured by the Incontinence Impact Questionnaire. Positive changes indicate improvement in incontinence-specific quality of life.|4-weeks post-intervention|Intention-to-treat||percentage change relative to baseline||Inter-Quartile Range|Mean
720170|NCT00305448|Secondary|Pharmacokinetic Parameter: Mean Volume of Distribution at Steady State, a Measure of the Apparent Volume in the Body Into Which Fulvestrant Distributes|The measure of dispersion for volume of distribution is based on the inter-individual variance estimated for the apparent volume of plasma into which Fulvestrant distributes|Baseline to 12 weeks|Patients who agreed to participate in the PK substudy.||Vss/F (L)||Standard Deviation|Mean
720171|NCT00305448|Secondary|Pharmacokinetic Parameter: Mean Population Clearance, a Measure of the Efficiency With Which Fulvestrant is Eliminated From the Body|The measure of dispersion for mean population clearance is based on the estimated inter-individual variance|Baseline to 12 weeks|Patients who agreed to participate in the PK substudy. The results are based on 148, 122 and 140 plasma-concentration records from patients in the 250 mg, 250 mg + LD and 500 mg treatment arms respectively.||L/h||Standard Deviation|Mean
720172|NCT00305448|Secondary|Clinical Benefit Rate (CBR)|A Clinical Benefit (CB) responder is defined as a patient having a best overall response of Complete response (CR), Partial Response (PR) or Stable disease (SD) provided SD (or better) was present = 154 days from randomization (ie SD = 24 weeks with the 2 week RECIST assessment time window allowed). The Clinical Benefit Rate is the percentage of patients with CB.|every 12 weeks(+/- 2 weeks) from randomization to data up to data cut-off, 19th March 2008.|||percentage of participants|||Number
720173|NCT00305448|Secondary|Duration of Response (DoR)|Time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who achieved a confirmed Complete Response or confirmed Partial Response.|RECIST tumour assessments carried out every 12 weeks from randomisation (+/- 2 weeks) until data cut-off on19th March 2008.||||||
720174|NCT00305448|Secondary|Time to Progression (TTP)|Time (in days) from randomization until objective disease progression or death (in the absence of objective progression). RECIST tumour assessments carried out every 12 weeks from randomization (+/- 2 weeks) until data cut-off on 19th March 2008.|every 12 weeks from randomization (+/- 2 weeks) until data cut-off (19th march 2008)|||days||Full Range|Median
720175|NCT00305448|Primary|Objective Response Rate (ORR)|"An objective response (OR) is defined as a patient having a best overall response of either complete response (CR) or partial response (PR). A patient has best overall response of CR if she had overall response of CR or PR on one visit and met the confirmation criteria per RECIST. ORR is defined as percentage of patients with objective response.
Each patient with measurable disease at baseline was assessed for OR from the sequence of Response Evaluation Criteria in Solid Tumors (RECIST) scan data up to data cut-off. RECIST scans were performed every 12 weeks (+/- 2weeks) from randomization"|baseline and every 12 weeks (+/- 2weeks) from randomization data up to data cut-off (19th march 2008)|||percentage of participants|||Number
720176|NCT00305565|Secondary|Inventory of Depressive Symptomatology Self-Report (IDS-SR) Mean Percent Change From Baseline to Week 50 of the Long-term Phase (ITT Population).|"The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.
The IDS-SR mean percent change at week 50"|From baseline to Study Week 50|||mean percent change||Standard Deviation|Mean
720177|NCT00305565|Secondary|Inventory of Depressive Symptomatology Self-Report (IDS-SR) Mean Change From Baseline to Week 50 of the Long-term Phase (ITT Population).|"The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.
The IDS-SR mean change at week 50"|From baseline to Study Week 50|||units on a scale||Standard Deviation|Mean
720178|NCT00305565|Secondary|Inventory of Depressive Symptomatology Self-Report (IDS-SR) Mean Percent Change From Baseline to Week 22 of the Acute Phase (ITT Population).|"The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.
The IDS-SR mean percent change at week 22"|From baseline to Study Week 22|||mean percent change||Standard Deviation|Mean
720179|NCT00305565|Secondary|Inventory of Depressive Symptomatology Self-Report (IDS-SR) Mean Change From Baseline to Week 22 of the Acute Phase (ITT Population).|"The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.
The IDS-SR mean change at week 22"|From baseline to Study Week 22|||units on a scale||Standard Deviation|Mean
720180|NCT00305565|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS) Mean Percent Change From Baseline to Week 50 of the Long-term Phase (ITT Population).|"The 10-item Montgomery-Asberg Scale (Montgomery and Asberg 1979) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 60. Higher values are considered to be worse outcomes.
The MADRS mean percent change at week 50"|From baseline to Study Week 50|||mean percent change||Standard Deviation|Mean
720181|NCT00305565|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS) Mean Change From Baseline to Week 50 of the Long-term Phase (ITT Population).|"The 10-item Montgomery-Asberg Scale (Montgomery and Asberg 1979) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 60. Higher values are considered to be worse outcomes.
The MADRS mean change at week 50"|From baseline to Study Week 50|||units on a scale||Standard Deviation|Mean
720182|NCT00305565|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS) Mean Percent Change From Baseline to Week 22 of the Acute Phase (ITT Population).|"The 10-item Montgomery-Asberg Scale (Montgomery and Asberg 1979) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 60. Higher values are considered to be worse outcomes.
The MADRS mean percent change at week 22"|From baseline to Study Week 22|||mean percent change||Standard Deviation|Mean
720183|NCT00305565|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS) Mean Change From Baseline to Week 22 of the Acute Phase (ITT Population).|"The 10-item Montgomery-Asberg Scale (Montgomery and Asberg 1979) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 60. Higher values are considered to be worse outcomes.
The MADRS mean change at week 22"|From baseline to Study Week 22|||units on a scale||Standard Deviation|Mean
720565|NCT00312494|Secondary|Anonymized Pharmacogenomic Blood Draw|Anonymized pharmacogenomic blood draw to evaluate the pharmacogenomic basis for ziprasidone treatment responsivity.|Baseline|All subjects eligible (optional consent); samples were not to be analyzed as part of the current protocol and the analysis was not to be covered by the statistical analysis plan.||mg|||Number
720184|NCT00305565|Secondary|Quick Inventory of Depressive Symptomatology-Clinician Administered (QIDS-C) Mean Percent Change From Baseline to Week 50 of the Long-term Phase (ITT Population).|"The 16-item Inventory of Depressive Symptomatology (QIDS) (Rush et al. 2003) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 27. Higher values are considered to be worse outcomes.
The QIDS-C mean percent change at week 50"|From baseline to Study Week 50|||mean percent change||Standard Deviation|Mean
720185|NCT00305565|Secondary|Quick Inventory of Depressive Symptomatology-Clinician Administered (QIDS-C) Mean Change From Baseline to Week 50 of the Long-term Phase (ITT Population).|"The 16-item Inventory of Depressive Symptomatology (QIDS) (Rush et al. 2003) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 27. Higher values are considered to be worse outcomes.
The QIDS-C mean change at week 50"|From baseline to Study Week 50|||units on a scale||Standard Deviation|Mean
720186|NCT00305565|Secondary|Quick Inventory of Depressive Symptomatology-Clinician Administered (QIDS-C) Mean Percent Change From Baseline to Week 22 of the Acute Phase (ITT Population).|"The 16-item Inventory of Depressive Symptomatology (QIDS) (Rush et al. 2003) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 27. Higher values are considered to be worse outcomes.
The QIDS-C mean percent change at week 22"|From baseline to Study Week 22|||mean percent change||Standard Deviation|Mean
720187|NCT00305565|Secondary|Quick Inventory of Depressive Symptomatology-Clinician Administered (QIDS-C) Mean Change From Baseline to Week 22 of the Acute Phase (ITT Population).|"The 16-item Inventory of Depressive Symptomatology (QIDS) (Rush et al. 2003) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 27. Higher values are considered to be worse outcomes.
The QIDS-C mean change at week 22"|From baseline to Study Week 22|||units on a scale||Standard Deviation|Mean
720188|NCT00305565|Secondary|Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Mean Percent Change From Baseline to Week 50 of the Long-term Phase (ITT Population).|"The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.
The IDS-C mean percent change at week 50"|From baseline to Study Week 50|||mean percent change||Standard Deviation|Mean
720189|NCT00305565|Secondary|Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Mean Change From Baseline to Week 50 of the Long-term Phase (ITT Population).|"The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.
The IDS-C mean change at week 50"|From baseline to Study Week 50|||units on a scale||Standard Deviation|Mean
720190|NCT00305565|Secondary|Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Mean Percent Change From Baseline to Week 22 of the Acute Phase (ITT Population).|"The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.
The IDS-C mean percent change at week 22"|From baseline to Study Week 22|||mean percent change||Standard Deviation|Mean
720191|NCT00305565|Post-Hoc|Regression Analysis of Change in MADRS Score vs. Total Charge Delivered Per Day|"Mixed models multivariate regression model was fitted for the outcome change from baseline MADRS score as a function of log dose, where dose is measured by millicoulombs (mC), adjusting for other important covariates (e.g., visit number, total number of major depressive episodes, prior ECT history, total number of adequate drug trials and prior medication regimen).
The 10-item Montgomery-Asberg Scale (Montgomery and Asberg 1979) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 60. Higher values are considered to be worse outcomes."|50 Weeks|50 Week Completers||Units on a scale per log(mC/Day)||Standard Error|Least Squares Mean
720192|NCT00305565|Post-Hoc|Regression Analysis of Change in IDS-C Score vs. Total Charge Delivered Per Day|"Mixed models multivariate regression model was fitted for the outcome change from baseline IDS-C score as a function of log dose, where dose is measured by millicoulombs (mC), adjusting for other important covariates (e.g., visit number, total number of major depressive episodes, prior electroconvulsive therapy (ECT) history, total number of adequate drug trials and prior medication regimen).
The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes."|50 Weeks|50 Week Completers||Units on a scale per log(mC/Day)||Standard Error|Least Squares Mean
720193|NCT00305565|Secondary|Inventory of Depressive Symptomatology Self-Report (IDS-SR) Percent Remitters From Baseline to Week 50 of the Long-term Phase (ITT Population).|"The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.
The IDS-SR percent of remitters at week 50. Remission was defined as a score of less than or equal to 14 on the IDS-C."|From baseline to Study Week 50|||percentage of participants|||Number
720194|NCT00305565|Secondary|Inventory of Depressive Symptomatology Self-Report (IDS-SR) Percent Responders From Baseline to Week 50 of the Long-term Phase (ITT Population).|"The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.
The IDS-SR percent of responders at week 50. Response was defined as greater than or equal to 50% improvement from baseline."|From baseline to Study Week 50|||percentage of participants|||Number
720195|NCT00305565|Secondary|Inventory of Depressive Symptomatology Self-Report (IDS-SR) Percent Remitters From Baseline to Week 22 of the Acute Phase (ITT Population).|"The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.
The IDS-SR percent of remitters at week 22. Remission was defined as a score of less than or equal to 14 on the IDS-C."|From baseline to Study Week 22|||percentage of participants|||Number
720220|NCT00305643|Primary|Incidence of Hand/Foot Syndrome (HFS) > Grade 1 at 16 Weeks Based on the CTC 3.0 Criteria.|The primary classification of palmar planter erythrodysethesia according to National Cancer Institute Common Toxicity Criteria (CTC) 3.0 criteria used to determine the incidences of > grade 1 hand and foot syndrome (HFS) by 16 weeks from the commencement of therapy.|At 16 Weeks, with evaluations and blood test every 3 weeks.|No analysis could be performed due to low accrual and no participants reaching the 16 week mark.|||||
720196|NCT00305565|Secondary|Inventory of Depressive Symptomatology Self-Report (IDS-SR) Percent Responders From Baseline to Week 22 of the Acute Phase (ITT Population).|"The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.
The IDS-SR percent of responders at week 22. Response was defined as greater than or equal to 50% improvement from baseline."|From baseline to Study Week 22|||percentage of participants|||Number
720197|NCT00305565|Secondary|Clinical Global Impressions Improvement Scale (CGI-I) Percent Response at Week 50 of the Long-term Phase (ITT Population).|"Originally, the Clinical Global Impressions-Improvement (CGI-I) (Guy W 1976)was designed as a 7-item scale used to assess how much the patient's illness had improved or worsened relative to a baseline state at the beginning of the intervention.(1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.)
In this study, the CGI-I was categorized into just two groups. A value of 1 (considered a response) was assigned for very much improved (at least 85% improvement) & much improved (at least 60% improvement). A value of 0 (considered non-response) was assigned for: minimally improved (at least 20-25% improvement), no change (between ±15% change), minimally worse (at least 20-55% worse), much worse (at least 60% worse), and very much worse (at least 80% worse). No score was assigned if the investigator did not provide a categorical rating at a particular follow-up visit."|At Study Week 50|||percentage of participants|||Number
720198|NCT00305565|Secondary|Clinical Global Impressions Improvement Scale (CGI-I) Percent Response at Week 22 of the Acute Phase (ITT Population)|"Originally, the Clinical Global Impressions-Improvement (CGI-I) (Guy W 1976)was designed as a 7-item scale used to assess how much the patient's illness had improved or worsened relative to a baseline state at the beginning of the intervention.(1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.)
In this study, the CGI-I was categorized into just two groups. A value of 1 (considered a response) was assigned for very much improved (at least 85% improvement) & much improved (at least 60% improvement). A value of 0 (considered non-response) was assigned for: minimally improved (at least 20-25% improvement), no change (between ±15% change), minimally worse (at least 20-55% worse), much worse (at least 60% worse), and very much worse (at least 80% worse). No score was assigned if the investigator did not provide a categorical rating at a particular follow-up visit."|At Study Week 22|||percentage of participants|||Number
720199|NCT00305565|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS) Percent Remitters From Baseline to Week 50 of the Long-term Phase (ITT Population).|"The 10-item Montgomery-Asberg Scale (Montgomery and Asberg 1979) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 60. Higher values are considered to be worse outcomes.
The MADRS percent of remitters at week 50. Remission was defined as a score of less than or equal to 9 on the MADRS."|From baseline to Study Week 50|||percentage of participants|||Number
720200|NCT00305565|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS) Percent Sustained Responders at Study Week 50 (ITT Population).|"The 10-item Montgomery-Asberg Scale (Montgomery and Asberg 1979) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 60. Higher values are considered to be worse outcomes.
Sustained Response is defined as the percentage of Acute Phase responders (week 22) who were also responders at the end of the Long-term (week 50) phase. An analysis of sustained response was performed using the MADRS to evaluate the long-term durability of the improvements in depression scores observed with adjunctive VNS Therapy."|From Baseline to Study Week 50|||percentage of participants|||Number
720201|NCT00305565|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS) Percent Responders From Baseline to Week 50 of the Long-term Phase (ITT Population).|"The 10-item Montgomery-Asberg Scale (Montgomery and Asberg 1979) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 60. Higher values are considered to be worse outcomes.
The MADRS percent of responders at week 50. Response was defined as greater than or equal to 50% improvement from baseline."|From baseline to Study Week 50|||percentage of participants|||Number
720202|NCT00305565|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS) Percent Remitters From Baseline to Week 22 of the Acute Phase (ITT Population).|"The 10-item Montgomery-Asberg Scale (Montgomery and Asberg 1979) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 60. Higher values are considered to be worse outcomes.
The MADRS percent of remitters at week 22. Remission was defined as a score of less than or equal to 9 on the MADRS."|From baseline to Study Week 22|||percentage of participants|||Number
720203|NCT00305565|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS) Percent Responders From Baseline to Week 22 of the Acute Phase (ITT Population).|"The 10-item Montgomery-Asberg Scale (Montgomery and Asberg 1979) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 60. Higher values are considered to be worse outcomes.
The MADRS percent of responders at week 22. Response was defined as greater than or equal to 50% improvement from baseline."|From baseline to Study Week 22|||percentage of participants|||Number
720204|NCT00305565|Secondary|Quick Inventory of Depressive Symptomatology-Clinician Administered (QIDS-C) Percent Remitters From Baseline to Week 50 of the Long-term Phase (ITT Population).|"The 16-item Inventory of Depressive Symptomatology (QIDS) (Rush et al. 2003) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 27. Higher values are considered to be worse outcomes.
The QIDS-C percent of remitters at week 50. Remission was defined as a score of less than or equal to 5 on the QIDS-C."|From baseline to Study Week 50|||percentage of participants|||Number
720205|NCT00305565|Secondary|Quick Inventory of Depressive Symptomatology-Clinician Administered (QIDS-C) Percent Responders From Baseline to Week 50 of the Long-term Phase (ITT Population).|"The 16-item Inventory of Depressive Symptomatology (QIDS) (Rush et al. 2003) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 27. Higher values are considered to be worse outcomes.
The QIDS-C percent of responders at week 50. Response was defined as greater than or equal to 50% improvement from baseline."|From baseline to Study Week 50|||percentage of participants|||Number
720206|NCT00305565|Secondary|Quick Inventory of Depressive Symptomatology-Clinician Administered (QIDS-C) Percent Remitters From Baseline to Week 22 of the Acute Phase (ITT Population).|"The 16-item Inventory of Depressive Symptomatology (QIDS) (Rush et al. 2003) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 27. Higher values are considered to be worse outcomes.
The QIDS-C percent of remitters at week 22. Remission was defined as a score of less than or equal to 5 on the QIDS-C."|From baseline to Study Week 22|||percentage of participants|||Number
720207|NCT00305565|Secondary|Quick Inventory of Depressive Symptomatology-Clinician Administered (QIDS-C) Percent Responders From Baseline to Week 22 of the Acute Phase (ITT Population).|"The 16-item Inventory of Depressive Symptomatology (QIDS) (Rush et al. 2003) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 27. Higher values are considered to be worse outcomes.
The QIDS-C percent of responders at week 22. Response was defined as greater than or equal to 50% improvement from baseline."|From baseline to Study Week 22|||percentage of participants|||Number
720208|NCT00305565|Secondary|Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Percent Remitters From Baseline to Week 50 of the Long-term Phase (ITT Population).|"The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.
The IDS-C percent of remitters at week 50. Remission was defined as a score of less than or equal to 14 on the IDS-C."|From baseline to Study Week 50|||percentage of participants|||Number
720209|NCT00305565|Secondary|Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Percent Sustained Responders at Study Week 50 (ITT Population).|"The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.
Sustained Response is defined as the percentage of Acute Phase responders (week 22) who were also responders at the end of the Long-term (week 50) phase. An analysis of sustained response was performed using the IDS-C to evaluate the long-term durability of the improvements in depression scores observed with adjunctive VNS Therapy."|From baseline to Study Week 50|||percentage of participants|||Number
720210|NCT00305565|Secondary|Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Percent Responders From Baseline to Week 50 of the Long-term Phase (ITT Population).|"The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.
The IDS-C percent of responders at week 50. Response was defined as greater than or equal to 50% improvement from baseline."|From baseline to Study Week 50|||percentage of participants|||Number
720211|NCT00305565|Secondary|Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Percent Remitters From Baseline to Week 22 of the Acute Phase (ITT Population).|"The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.
The IDS-C percent of remitters at week 22. Remission was defined as a score of less than or equal to 14 on the IDS-C."|From baseline to Study Week 22|||percentage of participants|||Number
720212|NCT00305565|Secondary|Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Percent Responders From Baseline to Week 22 of the Acute Phase (ITT Population).|"The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.
The IDS-C percent of responders at week 22. Response was defined as greater than or equal to 50% improvement from baseline."|From baseline to Study Week 22|||percentage of participants|||Number
720213|NCT00305565|Primary|Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Mean Change From Baseline to Week 22 of the Acute Phase (ITT Population).|The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.|From Baseline to Study Week 22|||units on a scale|Participants|Standard Error|Least Squares Mean
720214|NCT00305578|Primary|Change in 17-item Hamilton Depression Rating Scale From Baseline to 8 Weeks (Baseline - 8 Wks)|Scale for measurement of depression severity. Total of scale is used. Total range is from 0 - 50 with higher score signifying higher severity of depression. Outcome measure is change in score from baseline to 8 wks.|8 weeks|||units on a scale||Standard Deviation|Mean
720215|NCT00305604|Secondary|Rapidity of Onset of Action as Determined by Home Glucose Monitoring After 1 Week|Fingerstick glucose measurements were taken at 4 times (pre- and 2 hours post-breakfast and dinner) at each of Days -2, 3, and 7. The average of the 4 values was computed for each day. This outcome reflects the Day 7 average minus the Day -2 average.|Week 1|The Full Analysis Set (FAS) included all patients with a baseline value and >= 1 post-baseline value for this outcome. For FAS patients with no data at Day 7, the last observed measurement was carried forward to Day 7. Patients had the option to participate in self monitoring of glucose.||mg/dL||95% Confidence Interval|Least Squares Mean
720216|NCT00305604|Secondary|Change From Baseline in 2-hour PPG (Post-prandial Glucose) at Week 24|Change from baseline at Week 24 is defined as Week 24 minus Week 0.|Baseline and Week 24|The Full Analysis Set (FAS) included all patients with a baseline value and >= 1 post-baseline value for this outcome. For FAS patients with no data at Week 24, the last observed measurement was carried forward to Week 24.||mg/dL||95% Confidence Interval|Least Squares Mean
720217|NCT00305604|Secondary|Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24|Change from baseline at Week 24 is defined as Week 24 minus Week 0.|Baseline and Week 24|The Full Analysis Set (FAS) included all patients with a baseline value and >= 1 post-baseline value for this outcome. For FAS patients with no data at Week 24, the last observed measurement was carried forward to Week 24.||mg/dL||95% Confidence Interval|Least Squares Mean
720218|NCT00305604|Primary|Change From Baseline in HbA1c (Hemoglobin A1c) at Week 24|Change from baseline at Week 24 is defined as Week 24 minus Week 0.|Baseline and Week 24|The Full Analysis Set (FAS) included all patients with a baseline value and >= 1 post-baseline value for this outcome. For FAS patients with no data at Week 24, the last observed measurement was carried forward to Week 24.||Percent||95% Confidence Interval|Least Squares Mean
720219|NCT00305643|Secondary|Incidence of Hand/Foot Syndrome (HFS) > Grade 1 at 16 Weeks Based on WHO Criteria.|A secondary classification of palmar planter erythrodysethesia according to World Health Organization (WHO) criteria will be used for determination of the incidences of > grade 1 HFS by 16 weeks from the commencement of therapy.|At 16 Weeks|No analysis could be performed due to low accrual and no participants reaching the 16 week mark.|||||
720221|NCT00305760|Primary|Safety of Combining the Pancreatic Tumor Vaccine in Sequence With Cyclophosphamide and Erbitux. Safety is Defined as the Number of Treatment-related Grade 3 or 4 Adverse Events Observed in Greater Than 5% of the Patient Population||Continuous|||Adverse Events|||Number
720222|NCT00305773|Other Pre-specified|Time to Treatment Failure (TTF)|Time to treatment failure (TTF) was defined as the time from registration to until the date of treatment discontinuation of any reason. Patients receiving treatment at the time of analysis were considered censored. The median TTF with 95% CI was estimated using the Kaplan Meier method.|Duration of treatment (up to 17 cycles)|||days||90% Confidence Interval|Median
720223|NCT00305773|Secondary|Number of Participants With Severe (Grade 3, 4 or 5) Adverse Events|"Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.
Description of Grades:
Grade 1: Mild Grade 2: Moderate Grade 3: Severe Grade 4: Life-threatening Grade 5: Death"|Duration of study (up to 2 years)|||participants|||Number
720224|NCT00305773|Secondary|Overall Survival (OS)|Overall survival (OS) was defined as the time from registration to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% CI was estimated using the Kaplan Meier method.|Duration of study (up to 2 years)|||days||95% Confidence Interval|Median
720225|NCT00305773|Secondary|Time to Progression (TTP)|Time to Progression (TTP) for each patient will be calculated as the number of days from date of registration to either date when disease progression was documented or date of last evaluation without disease progression. The TTP distribution will be estimated using the method of Kaplan-Meier|Duration of study (up to 2 years)|This data was not (and will never be) analyzed. In place of this outcome, time to treatment failure, analyzed and reported as a secondary outcome.|||||
720226|NCT00305773|Primary|Confirmed Complete Response (CR) Rate|"The confirmed complete response rate was estimated by the number of participants with CR divided by the total number of evaluable participants.
According to the International Working Group (IWG) Criteria for response in AML, to be considered a CR, the following must be met for at least 4 weeks: ANC > 1500/mL, platelets > 100000/mL, no circulating blasts, bone marrow cellularity >20% (biopsy), trilineage maturation, < 5% bone marrow blasts, no auer rods and no extramedullary disease."|Up to 2 years|||percentage of participants||95% Confidence Interval|Number
720227|NCT00305864|Secondary|Progression-free Survival (Phase II)|Progression will be defined as a > 25% increase in tumor area.|From randomization to date of progression, death, or last follow-up. Analysis occurs at the same time as the primary outcome analysis.||||||
720228|NCT00305864|Primary|Median Overall Survival (Phase II)|Survival time was defined as the time from baseline to date of death from any cause. Patients last known to be alive are censored at date of last contact.|From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially forllowed for at least 18 months.|All eligible patients.||Months||95% Confidence Interval|Median
720229|NCT00305864|Primary|Maximum Tolerated Dose of MGd (Phase I)|"Patients were to be followed for a minimum of 90 days from the start of radiation therapy (RT) and carefully evaluated with respect to treatment morbidity. A dose limiting toxicity (DLT) was defined as a grade 4 neurologic adverse event (AE) considered to be related to treatment occurring within 21 days of the conclusion of RT. For each dose level, up to seven patients were to be accrued to assure that there would be six eligible for treatment adverse event evaluation. A dose level of MGd was considered acceptable if no more than 1 patient of the 6 experience a DLT. If the current level was considered acceptable, then dose escalation occurred. Otherwise, the preceding dose level would be declared the MTD. The MTD would be used for the Phase II arm.
Rating scale: 0 = not the MTD, 1 = MTD"|From start of radiation therapy to 90 days,|Eligible patients who received protocol treatment.||units on a scale|||Number
720230|NCT00305877|Secondary|Two-year Disease-free Survival (DFS)|Disease-free survival (DFS) is defined as the time from randomization to the first treatment failure (recurrence or death before recurrence).|Assessed every 3 months for 2 years, and every 6 months after completion of treatment for 2 years, then annually for 3 years|Eligible and treated patients.||Proportion of patients||95% Confidence Interval|Number
720231|NCT00305877|Secondary|Two-year Overall Survival Rate|Overall survival (OS) is defined as the time from randomization to death from any cause, or censored at last known date of survival.|Assessed every 3 months for 2 years|Eligible and treated patients are included in this analysis.||Proportion of patients||95% Confidence Interval|Number
720232|NCT00305877|Primary|Proportion of Patients With Specific Protocol Defined Adverse Event at Conclusion of All Therapy|"Specific toxicities to be monitored pursuant to the primary endpoint include:
Any grade 5 toxicities
Grade 4 dyspnea, neutropenic fever, allergic reaction, rash, wound dehiscence, wound infection, hypertension
Grade 3 or higher arterial thromboembolic phenomena, bleeding, phlebitis/deep vein thrombosis (DVT)/pulmonary embolism (PE), hemorrhage, ileus, bowel perforation, diarrhea, and mucositis
ECOG performance status decline by 2 or greater for >24 hours
Weight loss >10%"|Every 2 weeks while on treatment and for 30 days after the end of treatment|All treated patients were included in this analysis.||Proportion of patients||95% Confidence Interval|Number
720233|NCT00305942|Secondary|Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death|Overall survival was measured from the date of study entry until the date of death.|18 months|All patients were assessed for overall survival.||Months||95% Confidence Interval|Median
720234|NCT00305942|Secondary|Time to Progression (TTP), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease|Time to progression is defined as the interval between the start date of treatment and the date of occurrence of progressive disease.|18 months|All patients were assessed for time to progression.||Months||95% Confidence Interval|Median
720235|NCT00305942|Primary|Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment|"Overall response rate is the percent of patients experiencing a complete or partial response by RECIST v. 1 Criteria. Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters.
The final response category assigned represented the best response obtained during treatment."|18 months|All patients were included in the analysis.||percentage of participants||95% Confidence Interval|Number
720239|NCT00306189|Primary|Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|12 months|All subjects who received >= 1 dose of investigational product and have a baseline and >= 1 post baseline measurement at the lumbar spine.||Percent Change from Baseline||95% Confidence Interval|Mean
720240|NCT00306202|Secondary|Number of Participants With FLT3 and KIT Mutations in Stratum4 Ph- ALL/AML at End-Of-Treatment|FLT3 and KIT = These are fused genes found in participants with this type of leukemia.|At EOT (Median duration of therapy in months: Stratum 4=1.14 [Range: 0.03-3.38])|All treated participants in stratum 4: Participants who received at least 1 dose of study therapy.||participants|||Number
720241|NCT00306202|Secondary|Number of Participants With FLT3 and KIT Mutations in Stratum4 Ph- ALL/AML at Baseline|FLT3 and KIT = These are fused genes found in participants with this type of leukemia.|At baseline (within 3 weeks before initiation of study therapy)|All treated participants in stratum 4: Participants who received at least 1 dose of study therapy.||participants|||Number
720242|NCT00306202|Secondary|Number of Participants With BCR-ABL Mutations at End-of-Treatment: Stratum1 Ph+ CP-CML and Stratum2/3 Ph+ ALL or AP/BP-CML|BCR-ABL = These are fused genes found in participants with this type of leukemia.|At EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72])|All treated participants in strata 1 and 2/3: Participants who received at least 1 dose of study therapy.||participants|||Number
720243|NCT00306202|Other Pre-specified|Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) at Baseline by NCI CTCAE Version 3.0|GR1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. Normal ranges provided by local laboratory and may also vary from site to site. Low calcium: GR1=<LLN–8.0 mg/dL, GR2=<8.0–7.0 mg/dL, GR3=<7.0–6.0 mg/dL, GR4=<6.0 mg/dL; Low magnesium: GR1=<LLN–1.2 mg/dL, GR2=<1.2–0.9 mg/dL, GR3=<0.9–0.7 mg/dL, GR4=<0.7 mg/dL; Low phosphate: GR1=<LLN – 2.5 mg/dL, GR2=<2.5 – 2.0 mg/dL, GR3=<2.0 – 1.0 mg/dL, GR4=<1.0 mg/dL.|At baseline (within 1 week before initiation of study therapy)|All treated participants: Participants who received at least one dose of study therapy.||participants|||Number
720244|NCT00306202|Other Pre-specified|Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0|"GR1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. Normal ranges provided by local laboratory and may also vary from site to site. Aspartate aminotransferase (AST) and alanine aminotransferase(ALT): GR1=>ULN-2.5*ULN; GR2=>2.5-5.0*ULN; GR3=>5.0-20.0*ULN; GR4=>20.0*ULN. Total bilirubin:GR1=>ULN-1.5*ULN, GR2=>1.5-3.0*ULN, GR3=>3-10*ULN, GR4=>10*ULN. Creatinine: GR1=>ULN-1.5*ULN, GR2=>1.5-3.0*ULN, GR3=>3.0-6.0*ULN, GR4=>6.0*ULN.
ULN=upper limit of normal."|At baseline (within 1 week before initiation of study therapy)|All treated participants: Participants who received at least one dose of study therapy.||participants|||Number
720245|NCT00306202|Other Pre-specified|Number of Participants With Hematologic Toxicity at Baseline by NCI CTCAE Version 3.0|"GR1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. Normal ranges provided by local laboratory and may also vary from site to site. White Blood Cell (WBC):GR1=<LLN-3.0*10^9/L; GR2=<3.0-2.0*10^9/L; GR3=<2.0-1.0*10^9/L; GR4=<1.0*10^9/L. Absolute Neutrophil Count (ANC): GR1=<LLN-1.5*10^9 /L; GR2=<1.5-1.0*10^9/L; GR3=<1.0-0.5*10^9/L; GR4=<0.5*10^9/L. Hemoglobin: GR1=<LLN-10.0g/dL; GR2=<10.0-8.0g/dL; GR3=<8.0-6.5g/dL; GR4=<6.5g/dL. Platelets: GR1=<LLN-75.0*10^9/L; GR2=<75.0-50.0*10^9/L; GR3=<50.0-25.0*10^9/L; GR4=<25.0*10^9/L.
LLN=lower limit of normal."|At baseline (within 1 week before initiation of study therapy)|All treated participants: Participants who received at least one dose of study therapy.||participants|||Number
720246|NCT00306202|Secondary|Number of Participants With BCR-ABL Mutations at Baseline: Stratum1 Ph+ CP-CML and Stratum 2/3 Ph+ALL or AP/BP-CML|BCR-ABL, also referred to as the Philadelphia chromosome, is formed from the fusion of the BCR gene on chromosome 22 with the ABL gene on chromosome 9.|At baseline (within 3 weeks before initiation of study therapy)|All treated participants in strata 1 and 2/3: Participants who received at least 1 dose of study therapy.||participants|||Number
720247|NCT00306202|Secondary|Concentration of Dasatinib in Cerebrospinal Fluid (CSF) by Dose Level and Age Group|"Concentration of dasatinib in CSF was assessed only in participants who had lumbar puncture during the treatment.
y=years"|4 hours after oral dose|"All treated participants with CSF samples available. n=number of PK parameters included.
Each participant could have more than 1 CSF profiles sampled, depending on the number of times the dose of dasatinib was escalated."||ng/mL||Standard Deviation|Mean
720248|NCT00306202|Secondary|Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Dose Level and Age Group|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC(0-T) is the area under the plasma concentration-time curve from time zero to time of last quantifiable concentration.|During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).|"All treated participants with plasma samples available. n=number of PK parameters included.
Each participant could have more than 1 plasma profiles sampled, depending on the number of times the dose of dasatinib was escalated."||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
720249|NCT00306202|Secondary|Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) By Dose Level and Age Group|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Tmax is the time taken to reach the maximum observed plasma concentration.|During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).|"All treated participants with plasma samples available. n=number of PK parameters included.
Each participant could have more than 1 plasma profiles sampled, depending on the number of times the dose of dasatinib was escalated."||hour||Full Range|Median
721023|NCT00317941|Secondary|Mean Pain Assessment Using Visual Analogue Scale (VAS) Reported by Participants Immediately After Injection|Visual analogue scale was used to report the pain from 0 (no pain ) to 10 (maximal pain).|Immediately after injection|||Scores on a scale||Full Range|Mean
720250|NCT00306202|Secondary|Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic Parameter: Observed Maximum Plasma Concentration (Cmax) by Dose Level and Age Group|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Cmax is the maximum observed concentration of drug substance in plasma.|During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).|All treated participants with plasma samples available. n=number of PK parameters included. Each participant could have 1, 2, or 3 plasma PK profiles sampled, depending on the number of times the dose of dasatinib was escalated.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
720251|NCT00306202|Secondary|Dasatinib Plasma Pharmacokinetic Parameter: Terminal Half-life (T 1/2) by Dose Level and Age Group|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. T 1/2 is the time required for the concentration of the drug to reach half of its original value in plasma.|During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).|"All treated participants with plasma samples available. n=number of PK parameters included.
Each participant could have more than 1 plasma profiles sampled, depending on the number of times the dose of dasatinib was escalated."||hour||Standard Deviation|Mean
720252|NCT00306202|Secondary|Dasatinib Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF]) by Dose Level and Age Group|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC(INF) is the area under the plasma concentration-time curve from time zero extrapolated to infinite time.|During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).|"All treated participants with plasma samples available. n=number of PK parameters included.
Each participant could have more than 1 plasma profiles sampled, depending on the number of times the dose of dasatinib was escalated."||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
720253|NCT00306202|Secondary|Dasatinib Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Dose Level and Age Group|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC(0-T) is the area under the plasma concentration-time curve from time zero to time of last quantifiable concentration.|During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).|"All treated participants with plasma samples available. Each participant could have more than 1 plasma profiles sampled, depending on the number of times the dose of dasatinib was escalated.
n=number of PK parameters included."||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
720254|NCT00306202|Secondary|Dasatinib Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) By Dose Level and Age Group|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Tmax is the time taken to reach the maximum observed plasma concentration.|During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).|"All treated participants with plasma samples available. Each participant could have more than 1 plasma profiles sampled, depending on the number of times the dose of dasatinib was escalated.
n=number of PK parameters included."||hour||Full Range|Median
720255|NCT00306202|Secondary|Dasatinib Plasma Pharmacokinetic Parameter: Observed Maximum Plasma Concentration (Cmax) by Dose Level and Age Group|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Cmax is the maximum observed concentration of drug substance in plasma.|During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).|"All treated participants with plasma samples available. Each participant could have 1, 2, or 3 plasma PK profiles sampled, depending on the number of times the dose of dasatinib was escalated.
n=number of PK parameters included."||ng/mL||Geometric Coefficient of Variation|Geometric Mean
720256|NCT00306202|Secondary|Dasatinib Plasma Pharmacokinetic Parameter: Dose Normalized Area Under the Plasma Concentration Versus Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF]) by Age Group|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC (0-inf) is the area under the plasma concentration-time curve from time zero extrapolated to infinite time, normalized by dasatinib dose level.|During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).|"All treated participants with plasma samples available. Each participant could have 1, 2, or 3 plasma PK profiles sampled, depending on the number of times the dose of dasatinib was escalated.
n=number of PK parameters included."||ng.h/mL/mg/m^2||Geometric Coefficient of Variation|Geometric Mean
720257|NCT00306202|Secondary|Dasatinib Plasma Pharmacokinetic Parameter: Dose Normalized Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Age Group|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC[0-T] is the area under the plasma concentration-time curve from time zero to time of last quantifiable concentration, normalized by dasatinib dose level.|During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).|"All treated participants with plasma samples available. Each participant could have 1, 2, or 3 plasma PK profiles sampled, depending on the number of times the dose of dasatinib was escalated.
n=number of PK parameters included."||ng.h/mL/mg/m^2||Geometric Coefficient of Variation|Geometric Mean
720258|NCT00306202|Secondary|Dasatinib Plasma Pharmacokinetic Parameter: Dose Normalized Observed Maximum Plasma Concentration (Cmax) by Age Group|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Dose Normalized Cmax is the maximum observed concentration of drug substance in plasma normalized for different dasatinib dose levels.|During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).|"All treated participants with plasma samples available. Each participant could have 1, 2, or 3 plasma PK profiles sampled, depending on the number of times the dose of dasatinib was escalated.
n=number of PK parameters included."||ng/mL/mg/m^2||Geometric Coefficient of Variation|Geometric Mean
720292|NCT00306384|Secondary|Change From Baseline in Insulin Level|The change from Baseline in fasting insulin at the last post-baseline observation, collected within 7 days after the last dose of open-label study drug.|Baseline and Year 4|Safety set where data was available. Does not include patients enrolled in Protocol 01-05-TL-OPI322-001 or Protocol 01-06-TL-OPI322-002.||μIU/mL||Standard Deviation|Mean
720259|NCT00306202|Secondary|Dasatinib Plasma Pharmacokinetic Parameter: Terminal Half-life (T 1/2) by Age Group|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. T 1/2 is the time required for the concentration of the drug to reach half of its original value in plasma.|During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).|"All treated participants with plasma samples available. Each participant could have 1, 2, or 3 plasma PK profiles sampled, depending on the number of times the dose of dasatinib was escalated.
n=number of PK parameters included."||hours||Geometric Coefficient of Variation|Geometric Mean
720260|NCT00306202|Secondary|Dasatinib Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) by Age Group|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Tmax is the time taken to reach the maximum observed plasma concentration.|During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).|"All treated participants with plasma samples available. Each participant could have 1, 2, or 3 plasma PK profiles sampled, depending on the number of times the dose of dasatinib was escalated.
n=number of PK parameters included."||hours||Full Range|Median
720261|NCT00306202|Secondary|Overall Survival (OS)|Defined as time in months from start of study therapy to death. The OS was estimated using the Kaplan-Meier product-limit method, and a two-sided 95% CI for the median OS time was computed using the Brookmeyer and Crowley method.|From start of study therapy until death or 5 years after EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38])|All treated participants: Participants who received at least 1 dose of study therapy. Participants lost to followup were censored on the last date the participant was known to be alive.||months||95% Confidence Interval|Median
720262|NCT00306202|Secondary|Progression Free Survival (PFS)|"Time in months from 1st first dose until progression (resistance or refractory disease) or death was first documented by investigator.
Progressive disease: Resistant disease for which investigator may electively stop treatment or refractory disease requiring cessation of study treatment.
The PFS was estimated using the Kaplan-Meier product-limit method, and a two-sided 95% CI for the median PFS time was computed using the method of Brookmeyer and Crowley."|From the date of randomization to date of progression, death, last tumor assessment, or 5 years after EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38])|"All treated participants: Participants who received at least 1 dose of study therapy.
If no progression or death was reported, PFS was censored at the last assessment date done on-study (i.e., up to 30 days after last dosing date) at which non-progression was reported."||months||95% Confidence Interval|Median
720263|NCT00306202|Secondary|Number of Participants With Major Molecular Response (MMR) in Stratum 2/3 (Ph+ ALL or AP/BP-CML)|"Molecular response was calculated by measuring BCR-ABL transcripts in blood during treatment using qPCR assay.
MMR: Ratio of the BCR-ABL to ABL <10^-3 or a ≥3 log reduction from baseline in participants with p190 variant; ratio of the BCR-ABL to ABL <10^-3 on the international scale in participants with p210 variant.
BCR-ABL=the fused gene found in participants with this type of CML."|At baseline (within 3 weeks before initiation of study therapy), After hematologic response, EOT (Median duration of therapy in months: Stratum 2/3=3.02 [Range: 0.53-37.72])|All treated participants (14 with p190 variant and 3 with p210 variant BCR-ABL transcripts) in stratum 2/3: Participants who received at least 1 dose of study therapy.||participants|||Number
720264|NCT00306202|Secondary|Number of Participants With Molecular Responses in Stratum 1 (Ph+ CP-CML)|"Molecular response was calculated by measuring p210 variant of BCR-ABL transcripts in blood during treatment using quantitative polymerase chain reaction (qPCR) assay.
Major molecular response (MMR): Ratio of the BCR-ABL to ABL <10^-3 or 0.1% on the international scale.
Complete molecular response (CMR): Complete absence of BCR-ABL or the ratio is <10^-4.5 or 0.00316% on the international scale.
Confirmed MMR or CMR = Criteria met again >6 weeks. BCR-ABL=the fused gene found in participants with this type of CML."|At baseline (within 3 weeks before initiation of study therapy), After hematologic response, EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63])|All treated participants in stratum 1: Participants who received at least 1 dose of study therapy.||participants|||Number
720265|NCT00306202|Secondary|Percentage of Participants With Confirmed Hematologic Response (HR) at Recommended Phase II Dose: Stratum 2/3 (Ph+ALL or AP/BP-CML)|"A participant is said to have a confirmed HR if criteria for HR were fulfilled again at least 28 days after they first met with no concomitant use of anagrelide or hydroxyurea during this interval.
Confirmed HR observed in stratum 2/3 was either CHR or MaHR or overall hematologic response (OHR).
Refer to Outcome Measure 19 for criteria for CHR and MaHR. OHR is defined as MaHR or MiHR. MiHR=CHRp except blasts in BM (≥ 5% and ≤ 15% blasts in BM). The Clopper and Pearson method was used to compute 95% exact CIs."|Days 8, 15, 22, 29, 36, 43; Weeks 4, 7, 13, 19, 25, 31, 37; then every 12 weeks upto 24 months; then once/year; EOT (Median duration of therapy in months: Stratum 2/3=3.02 [Range: 0.53-37.72])|All treated participants in stratum 2/3: Participants who received at least 1 dose of dasatinib 80 mg/m^2.||percentage of participants||95% Confidence Interval|Number
720266|NCT00306202|Secondary|Percentage of Participants With Confirmed Hematologic Response (HR) at Recommended Phase II Dose: Stratum 1 (Ph+ CP-CML)|"A participant was said to have a confirmed HR if all the criteria for HR were fulfilled again at least 28 days after they first met with no concomitant use of anagrelide or hydroxyurea during this interval.
HR observed in stratum 1 was CHR. Refer to Outcome Measure 20 for criteria for CHR.
The Clopper and Pearson method was used to compute 95% exact CIs."|Days 8, 15, 22, 29, 36, 43; Weeks 7, 13, 25, 37; then every 12 weeks upto 24 months; then once/year; EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63])|All treated participants in stratum 1 who received at least 1 dose of dasatinib 60 mg/m^2.||percentage of participants||95% Confidence Interval|Number
720293|NCT00306384|Secondary|Change From Baseline in Proinsulin Level|"Proinsulin is a precursor to insulin, and was measured as an indicator of pancreatic function. The change from Baseline in fasting proinsulin to the last post-baseline observation, collected within 7 days after the last dose of open-label study drug.
Note: A transcription error occurred in the reporting of 1 proinsulin value for a patient in the alogliptin 25 mg completed group, for whom a partial patient ID number was mistakenly entered as an end-of-treatment proinsulin level."|Baseline and Year 4|Safety set where data were available.||pmol/L||Standard Deviation|Mean
720267|NCT00306202|Secondary|Duration of Complete Hematologic Response (CHR): Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ALL or AP/BP-CML)|"Duration of CHR is the time (in months) from the first day criteria were met for CHR, provided they were confirmed later (after 28 days) with no concomitant use of anagrelide or hydroxyurea during this interval until death or progression was first observed. Refer to Outcome Measure 20 for criteria for CHR (Stratum 1) and Outcome Measure 19 for CHR (Stratum 2/3).
The Kaplan-Meier plot was used. A 2-sided, 95% CI for the median was computed using the Brookmeyer and Crowley method."|From the date of first confirmed CHR to date of progression, death, or last tumor assessment (maximum participant duration of response of 50 months).|Treated participants with CHR in strata 1 and 2/3. Participants who neither discontinued due to progression nor progressed nor died were censored on the date of their last hematologic or cytogenetic assessment, whichever came last.||months||95% Confidence Interval|Median
720268|NCT00306202|Secondary|Duration of Major Hematologic Response (MaHR): Stratum 2/3 (Ph+ALL or AP/BP-CML)|"Duration of MaHR is the time (in months) from the first day criteria were met for MaHR, provided they were confirmed later at least after 28 days with no concomitant use of anagrelide or hydroxyurea during this interval, until death or progression was first observed.
MaHR: Defined as participants having as best response a CHR or CHRp. Refer to outcome measure 20 for criteria for CHR or CHRp. The Kaplan-Meier plot was used. A 2-sided, 95% CI for the median was computed using the Brookmeyer and Crowley method."|From the date of first confirmed MaHR to date of progression, death, or last tumor assessment (maximum participant duration of response of 37 months).|All treated participants with MaHR in stratum 2/3. Participants who neither discontinued due to progression nor progressed nor died were censored on the date of their last hematologic or cytogenetic assessment, whichever came last.||months||95% Confidence Interval|Median
720269|NCT00306202|Secondary|Time to Complete Hematologic Response (CHR): Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ALL or AP/BP-CML)|"Time to CHR is the time (in days) from first dose of dasatinib until the first day CHR criteria were met, provided they were confirmed later after 28 days with no concomitant use of anagrelide or hydroxyurea during this interval.
Refer to Outcome Measure 16 for criteria to CHR in Stratum 1 and to Outcome Measure 15 for criteria for CHR in Stratum 2/3.
Estimated by the Kaplan-Meier method and a 2-sided 95% CI for median was computed using the Brookmeyer and Crowley method."|Days 8, 15, 22, 29, 36, 43; Weeks 7, 13, 25, 37; at Week 4, 19, 31 (only stratum 2/3); then every 12 weeks upto 24 months; then once/year; until criteria was first met for CHR (maximum participant time to first CHR of 65 days).|All treated participants with CHR in strata 1 and 2/3.||days||95% Confidence Interval|Median
720270|NCT00306202|Secondary|Time to Major Hematologic Response (MaHR): Stratum 2/3 (PH+ ALL or AP/BP-CML)|"Defined as time (in days) from first dose of dasatinib until the first day MaHR criteria were met, provided they were confirmed later (after 28 days) with no concomitant use of anagrelide or hydroxyurea during this interval.
MaHR: Defined as participants having as best response a CHR or CHRp. Refer to Outcome Measure 15 for criteria for CHR and CHRp. Estimated by the Kaplan-Meier method and a 2-sided, 95% CI for the median was computed using the Brookmeyer and Crowley method."|Days 8, 15, 22, 29, 36, 43; Weeks 4, 7, 13, 19, 25, 31, 37; then every 12 weeks upto 24 months; then once/year; until confirmed MaHR (maximum participant time to first MaHR of 44 days).|Treated participants with MaHR in stratum 2/3.||days||95% Confidence Interval|Median
720271|NCT00306202|Secondary|Best Hematologic Response (HR) At Any Time: Stratum 4 (Ph- ALL/AML)|HR was determined by CBC, differential, and platelet count. Unable to determine = Participants without any valid hematologic assessments.|Days 8, 15, 22, 29, 36, 43; Weeks 4, 7, 10, 13, 19, 25, 31, 37; then every 12 weeks upto 24 months; then once/year; EOT (Median duration of therapy in months: Stratum 4=1.14 [Range: 0.03-3.38])|All treated participants in stratum 4: Participants who received at least 1 dose of study therapy.||participants|||Number
720272|NCT00306202|Secondary|Best Hematologic Response (HR) At Any Time: Stratum 2/3 (Ph+ ALL or AP/BP-CML)|"HR was determined by CBC, differential, and platelet count. Refer to outcome measure 15 for criteria for CHR and CHRp. Criteria for minor hematologic response (MiHR): CHRp except blasts in BM-≥5% and ≤15% blasts in BM.
Unconfirmed HR = All criteria met. periph=peripheral. Confirmed HR = Criteria for HR fulfilled again at least 28 days after they first met with no concomitant use of anagrelide or hydroxyurea during this interval."|Days 8, 15, 22, 29, 36, 43; Weeks 4, 7, 13, 19, 25, 31, 37; then every 12 weeks up to 24 months; then once/year; EOT (Median duration of therapy in months: Stratum 2/3=3.02 [Range: 0.53-37.72])|All treated participants in Stratum 2/3: Participants who received at least 1 dose of study therapy.||participants|||Number
720273|NCT00306202|Secondary|Best Hematologic Response (HR) At Any Time: Stratum 1 (Ph+ CP-CML)|"HR: Determined by complete blood count (CBC), differential, and platelet count (PLT). Criteria for complete hematologic response (CHR):
WBC in PB: <10,000/mm^3; Immature cells in PB: No blasts or promyelocytes (myelocytes + metamyelocytes) <5%; Basophils in PB: <5%; Platelet count (untransfused): <450,000/mm^3; Extra medullary disease: No extramedullary leukemia, including no splenomegaly.
Unconfirmed HR = All criteria met. Confirmed HR = Criteria for HR fulfilled again at least 28 days after they first met with no concomitant use of anagrelide or hydroxyurea during this interval."|Days 8, 15, 22, 29, 36, 43; Weeks 7, 13, 25, 37; then every 12 weeks upto 24 months; then once/year; EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63])|All treated participants in stratum 1: Participants who received at least 1 dose of study therapy.||participants|||Number
720274|NCT00306202|Secondary|Number of Participants With Major Hematologic Response (MaHR) in Stratum 2/3 (Ph+ ALL or AP/BP-CML) Within First 6 and 24 Weeks|"Defined as participants having as best response a CHR or CHRp.
Criteria:
CHR-WBC in PB:≤ULN; Immature cells in PB:No blasts, promyelocytes, myelocytes, metamyelocytes; Platelet count (untransfused):≥100,000/mm^3 and ≤450,000/mm^3; ANC:≥ 1000/mm^3; Blasts in BM:<5%; Extra medullary disease:No extramedullary leukemia, including no hepato or splenomegaly (regardless of CNS involvement).
CHRp-CHR except platelet count (untransfused) and ANC:20,000/mm^3 ≤platelet <100,000/mm^3 and /or 500/mm^3 ≤ANC ≤1000/mm^3."|After completion of Week 6 and 24 (measured at weeks 7 and 25)|All treated participants in Stratum 2/3: Participants who received at least 1 dose of study therapy.||participants|||Number
720294|NCT00306384|Secondary|Percentage of Participants With Marked Hyperglycemia|"Marked Hyperglycemia is defined as fasting plasma glucose greater than or equal to 200 mg/dL (≥11.10 mmol/L).
The Month 42 to Month 45 interval includes all marked hyperglycemic episodes occurring on or after Day 1247 (a 203-day visit window)."|Randomization up to 4 years.|Safety set where data were available.||percentage of participants|||Number
720275|NCT00306202|Secondary|Number of Participants With Major Hematologic Response (MaHR) at Any Time in Stratum 2/3 (Ph+ ALL or AP/BP-CML) and Stratum 4 (Ph- ALL/AML)|"Defined as participants having as best response complete hematologic response (CHR) or CHR with incomplete platelet recovery (CHRp).
Criteria:
CHR-WBC in Peripheral Blood (PB):≤ULN; Immature cells in PB:No blasts, promyelocytes, myelocytes, metamyelocytes; Platelet count (untransfused):≥100,000/mm^3 and ≤450,000/mm^3; ANC:≥ 1000/mm^3; Blasts in BM:<5%; Extra medullary disease:No extramedullary leukemia, including no hepato or splenomegaly (regardless of CNS involvement).
CHRp-CHR except platelet count (untransfused) & ANC:20,000/mm^3 ≤platelet <100,000/mm^3 & /or 500/mm^3 ≤ANC ≤1000/mm^3."|Days 8, 15, 22, 29, 36, 43; Weeks 4, 7, 13, 19, 25, 31, 37; at Week 10 (only stratum 4); then every 12 weeks upto 24 months; then once/year; EOT(Median duration of therapy in months: Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38])|All treated participants in strata 2/3 and 4: Participants who received at least 1 dose of study therapy.||participants|||Number
720276|NCT00306202|Secondary|Duration of Complete Cytogenetic Response (CCyR) in Responders: Stratum 1 [Ph+ CP-CML] and Stratum 2/3 [Ph+ ALL or AP/BP-CML]|"Defined as time (in months) from the first day that all criteria were met for CCyR until the date of progression (based on the Investigator’s assessment) or death (for participants whose best response was CCyR).
CCyR = 0% Ph+ metaphases of ≥ 20 analyzed metaphases in BM aspiration. The Kaplan-Meier plot was used. A 2-sided, 95% CI for the median was computed using the Brookmeyer and Crowley method."|From the date of first CCyR assessment to date of progression, death, or last tumor assessment (maximum participant duration of response of 45.1 months)|All treated participants who had cytogenetic response. Participants with at least 1 metaphase observed & the number of Ph+ metaphases smaller than the total number of metaphases [%Ph+ <100%]) were considered responders. Participants who neither progressed nor died were censored on the date of their last valid cytogenetic assessment.||months||95% Confidence Interval|Median
720277|NCT00306202|Secondary|Duration of Major Cytogenetic Response (MCyR) in Responders (Stratum 1 [Ph+ CP-CML] and Stratum 2/3 [Ph+ ALL or AP/BP-CML])|"Defined as the time (in months) from the first day that all criteria were met for MCyR until the date of progression (based on the Investigator’s assessment) or death (for participants whose best responses were MCyR and CCyR respectively).
MCyR: A cytogenetic response that was either CCyR or PCyR. CCyR: 0% Ph+ cells in metaphase in BM. PCyR: >0% to 35% Ph+ cells in metaphase in BM. The Kaplan-Meier plot was used. A 2-sided, 95% CI for the median was computed using the Brookmeyer and Crowley method."|From the date of first MCyR assessment to date of progression, death, or last tumor assessment (maximum participant duration of response of 48.6 months)|All treated participants who had cytogenetic response. Participants with at least 1 metaphase observed & the number of Ph+ metaphases smaller than the total number of metaphases [%Ph+ <100%]) were considered responders. Participants who neither progressed nor died were censored on the date of their last valid cytogenetic assessment.||months||95% Confidence Interval|Median
720278|NCT00306202|Secondary|Time to Major Cytogenetic Response (MCyR) in Responders: Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ ALL or AP/BP-CML)|Defined as time (in days) from the first dose of dasatinib until criteria were first met for MCyR. MCyR: A CyR that was either CCyR or PCyR. CCyR: 0% Ph+ cells in metaphase in BM. PCyR: >0% to 35% Ph+ cells in metaphase in BM. The Kaplan-Meier plot was used. A 2-sided, 95% confidence interval (CI) for the median was computed using the Brookmeyer and Crowley method.|Strata 1 and 2/3: At Weeks 7, 13, 25, 37, then every 12 weeks; Stratum 2/3: Additionally at Weeks 4, 19, 31; until first MCyR (maximum participant time to first MCyR of 92 days).|All treated participants who had cytogenetic response. Participants with at least 1 metaphase observed & the number of Ph+ metaphases smaller than the total number of metaphases [%Ph+ <100%]) were considered responders.||days||95% Confidence Interval|Median
720279|NCT00306202|Secondary|Percentage of Participants With Complete Cytogenetic Response (CCyR) or Major Cytogenetic Response (MCyR) at Recommended Phase II Dose|"Cytogenetic responses were based on the karyotype analysis of the percentage of Ph+ metaphases among cells in metaphase on a BM sample. At least 20 metaphase cells from a BM sample were evaluated.
MCyR: A cytogenetic response that was either CCyR or PCyR. CCyR: 0% Ph+ cells in metaphase in BM. PCyR: >0% to 35% Ph+ cells in metaphase in BM."|Strata 1 and 2/3: At Week 7, 13, then every 12 weeks, and EOT; Stratum 2/3: Additionally at Week 4, 19, 31 (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72])|All treated participants in strata 1 and 2/3: Participants who received at least 1 dose of study therapy.||percentage of participants||95% Confidence Interval|Number
720280|NCT00306202|Secondary|Best Cytogenetic Response (CyR) in Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ ALL or AP/BP-CML)|"Best CyR was assessed based on the percentages of Ph+ metaphases of ≥20 analyzed metaphases in BM sample.
Participants with complete, partial, minor, minimal, or no CyR. Refer to Outcome Measure 7 for definitions of CCyR and PCyR. Minor CyR:>35%-65% Ph+ cells in metaphase in BM. Minimal CyR:>65%-95% Ph+ cells in metaphase in BM. No CyR:>95%-100% Ph+ cells in metaphase in BM. Unable to determine:Participants without valid cytogenetic assessment (i.e., at least 1 metaphase observed and number of Ph+ metaphases smaller than total number of metaphases [%Ph+ <100%])."|Strata 1 and 2/3: At Weeks 7, 13, then every 12 weeks, and EOT; Stratum 2/3: Additionally at Weeks 4, 19, 25, 31 (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72])|"All treated participants (strata 1 and 2/3): Participants who received at least 1 dose of study therapy.
Stratum 2/3 dasatinib 80 mg/m^2 dose cohort includes 1 participant as having a CCyR due to a data entry error that was fixed after database lock for this study."||participants|||Number
720281|NCT00306202|Secondary|Number of Participants With Major Cytogenetic Response (MCyR) in Stratum 1 (Ph+ CP-CML) Within First 12 and 24 Weeks|"Cytogenetic responses were based on the karyotype analysis of the percentage of Ph+ metaphases among cells in metaphase on a BM sample. At least 20 metaphase cells from a BM sample were evaluated.
MCyR: A cytogenetic response that was either CCyR or PCyR. CCyR: 0% Ph+ cells in metaphase in BM. PCyR: >0% to 35% Ph+ cells in metaphase in BM."|After completion of Week 12 and 24 (measured at Weeks 13 and 25)|All treated participants in stratum 1: Participants who received at least 1 dose of study therapy.||participants|||Number
720295|NCT00306384|Secondary|Change From Baseline in Fasting Plasma Glucose|The change from Baseline in fasting plasma glucose (FPG) at the last post-baseline observation, collected within 7 days after the last dose of open-label study drug.|Baseline and Year 4|Safety set where data were available.||mg/dL||Standard Deviation|Mean
721024|NCT00317941|Secondary|Percentage of Injection Sites Without Pain Reported by Participants||Up to 3 months assessed 24 hours after each injection|||Percentage of injection sites|Participants||Number
720282|NCT00306202|Secondary|Number of Participants With Major Cytogenetic Response (MCyR) at Any Time in Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ ALL or AP/BP-CML)|"Cytogenetic responses were based on the karyotype analysis of the percentage of Ph+ metaphases among cells in metaphase on a BM sample. At least 20 metaphase cells from a BM sample were evaluated.
MCyR: A cytogenetic response that is either complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR).
CCyR: 0% Ph+ cells in metaphase in BM. PCyR: >0% to 35% Ph+ cells in metaphase in BM."|Strata 1 and 2/3: At Week 7, 13, then every 12 weeks, and EOT; Stratum 2/3: Additionally at Week 4, 19, 31 (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72])|All treated participants in strata 1 and 2/3: Participants who received at least 1 dose of study therapy.||participants|||Number
720283|NCT00306202|Secondary|Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0|GR1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. Normal ranges provided by local laboratory and may also vary from site to site. AST and ALT: GR1=>ULN-2.5*ULN; GR2=>2.5-5.0*ULN; GR3=>5.0-20.0*ULN; GR4:>20.0*ULN. Total bilirubin:GR1=>ULN-1.5*ULN, GR2=>1.5-3.0*ULN, GR3=>3-10*ULN, GR4=>10*ULN. Creatinine: GR1=>ULN-1.5*ULN, GR2=>1.5-3.0*ULN, GR3=>3.0-6.0*ULN, GR4=>6.0*ULN.|Days 22 and 43, then every 12 weeks, then every 24 weeks after 24 months of treatment, EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38])|All treated participants: Participants who received at least one dose of study therapy.||participants|||Number
720284|NCT00306202|Secondary|Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0|GR1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. Normal ranges provided by local laboratory and may also vary from site to site. Low calcium: GR1=<LLN–8.0 mg/dL, GR2=<8.0–7.0 mg/dL, GR3=<7.0–6.0 mg/dL, GR4=<6.0 mg/dL; Low magnesium: GR1=<LLN–1.2 mg/dL, GR2=<1.2–0.9 mg/dL, GR3=<0.9–0.7 mg/dL, GR4=<0.7 mg/dL; Low phosphate: GR1=<LLN – 2.5 mg/dL, GR2=<2.5 – 2.0 mg/dL, GR3=<2.0 – 1.0 mg/dL, GR4=<1.0 mg/dL.|Days 22 and 43, then every 12 weeks, then every 24 weeks after 24 months of treatment, EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38])|All treated participants: Participants who received at least one dose of study therapy.||participants|||Number
720285|NCT00306202|Secondary|Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0|GR1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. Normal ranges provided by local laboratory and may also vary from site to site. WBC: GR1=<LLN-3.0*10^9/L; GR2=<3.0-2.0*10^9/L; GR3=<2.0-1.0*10^9/L; GR4=<1.0*10^9/L. ANC: GR1=<LLN-1.5*10^9 /L; GR2=<1.5-1.0*10^9/L; GR3=<1.0-0.5*10^9/L; GR4=<0.5*10^9/L. Hemoglobin: GR1=<LLN-10.0g/dL; GR2=<10.0-8.0g/dL; GR3=<8.0-6.5g/dL; GR4=<6.5g/dL. Platelets: GR1=<LLN-75.0*10^9/L; GR2=<75.0-50.0*10^9/L; GR3=<50.0-25.0*10^9/L; GR4=<25.0*10^9/L.|Days 8, 15, 22, 29, 36, 43, then every 3 weeks, then every 3 months after 1 Year, EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38])|All treated participants: Participants who received at least one dose of study therapy.||participants|||Number
720286|NCT00306202|Secondary|Number of Participants With Dose-limiting Toxicity (DLT)|"DLTs: AEs which were at least possibly drug-related occurring within first 3 weeks of dasatinib therapy (toxicities occurring after 21 days were also considered) and are:-
Any nonhematologic clinically-apparent toxicity of Grade(GR)≥3 occurring despite appropriate medical management and GR4 laboratory abnormality/GR3 lasting ≥7 days
GR4 neutropenia or thrombocytopenia lasting ≥7 days and not explained by the presence of leukemia after hematopoietic reconstitution
Any clinically important toxicity of GR≥2 requiring treatment discontinuation or interruption ≥7 days."|From the date of first dose until at least 30 days after the last dose of study drug (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38])|All treated participants: Participants who received at least 1 dose of study therapy.||participants|||Number
720287|NCT00306202|Secondary|Number of Participants With Related Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0.|"AE: New untoward medical occurrence or worsening of a preexisting medical condition that does not have causal relationship with this treatment. SAE: Untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, drug dependency/abuse; life-threatening, an important medical event, a congenital anomaly/birth defect; requires inpatient hospitalization/prolongs existing hospitalization.
Grade 3 = Severe; Grade 4 = Life-threatening or disabling."|From the date of first dose until at least 30 days after the last dose of study drug (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38])|All treated participants: Participants who received at least 1 dose of study therapy.||participants|||Number
720288|NCT00306202|Primary|Recommended Phase II Dose of Dasatinib in Children and Adolescents With Relapsed or Refractory Leukemia|The recommended phase 2 dasatinib dose was determined based on efficacy, safety, and pharmacokinetic data obtained at the prespecified dose levels.|From the date of first dose to end-of-treatment (EOT) (Median duration of therapy in months: Stratum 1=24.11 [Range:2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38])|All treated participants: Participants who received at least 1 dose of study therapy||mg/m^2 QD|||Number
720289|NCT00306384|Secondary|Percentage of Participants With a Clinical Response|"Clinical response was defined based on the absolute value of HbA1c meeting one of two clinical targets at any post-baseline visit:
HbA1c ≤6.5%;
HbA1c ≤7.0%."|Weeks 2, 4, 8, 12, every 3 months up to 4 years, and 1 Day after final dose.|Safety set.||percentage of participants|||Number
720290|NCT00306384|Secondary|Change From Baseline in Body Weight|Change from Baseline in body weight to the last post-baseline observation collected within 7 days after the last dose of open-label study drug.|Baseline and Year 4|Safety set for whom data was available.||kg||Standard Deviation|Mean
720291|NCT00306384|Secondary|Change From Baseline in C-peptide Level|C-peptide is a byproduct created when the hormone insulin is produced and is measured by a blood test. Change from Baseline to the last post-baseline observation, collected within 7 days after the last dose of open-label study drug.|Baseline and Year 4|Safety set where data was available. Patients enrolled in Protocol 01-05-TL-OPI322-001 or Protocol 01-06-TL-OPI322-002 are not included.||ng/mL||Standard Deviation|Mean
721025|NCT00317941|Secondary|Percentage of Injection Sites Without Pain Reported by Physicians||Up to 3 months|||Percentage of injection sites|Participants||Number
720296|NCT00306384|Secondary|Change From Baseline Over Time in Glycosylated Hemoglobin|The change from Baseline in glycosylated hemoglobin (HbA1c; the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) during the study. Endpoint was defined as the last postbaseline observation collected within 7 days after the last dose of open-label study drug.|Baseline and Month 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42 and 45.|Safety set where data were available.||percent glycosylated hemoglobin||Standard Deviation|Mean
720297|NCT00306384|Primary|Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)|Safety was assessed by physical examinations, clinical laboratory parameters, electrocardiogram (ECG) readings, vital sign measurements, oral temperature, and hypoglycemic events. Changes in laboratory values or ECG parameters were considered to be adverse events if they were judged to be clinically significant. A TEAE was any event that started on or after the first dose of open-label study drug and within 14 days after the last dose.|4 years|Safety set||percentage of participants|||Number
720298|NCT00306488|Secondary|The Change in Total Drusen Area From Baseline to Year 2.||2 years||||||
720299|NCT00306488|Secondary|The Change in the Number of Scotomatous Points Between Study and Fellow Eyes From Baseline to Year 2.|Scotomatous points are testing points on microperimetry examination that are centered on the macula and report a lack of retinal sensitivity within the range tested.|2 years||||||
720300|NCT00306488|Secondary|The Change in Contrast Sensitivity as Measured by the Pelli-Robson Chart From Baseline to Year 2.|The Pelli-Robson Chart is comprised of 10 groups of 3 large letters with levels of contrast ranging from 100% (black against white) to 1% (very light gray against white). Each eye is assigned a score based on the contrast of the last group in which two or three letters were correctly read. A score of 2 log units, which represents a normal sensitivity contrast, indicates that the eye was able to detect two of the three letters with a contrast of 1 percent (contrast sensitivity = 100 percent or log 2).|2 years|"Data collected from the ten participants that completed the full twenty-four months of the study were analyzed.
Ten study eyes and ten fellow eyes were analyzed."||Log Units|Participants|Standard Deviation|Mean
720301|NCT00306488|Secondary|The Change in GA, as Measured on Stereoscopic Color Fundus Photography (CFP) From Baseline to Year 2.|GA was also measured using Stereoscopic Color Fundus Photography (CFP), which produces color images of the inside of the eye.|2 years|"Data collected from the ten participants that completed the full twenty-four months of the study were analyzed.
Ten study eyes and ten fellow eyes were analyzed."||mm^2|Participants|Standard Deviation|Mean
720302|NCT00306488|Secondary|The Change in Geographic Atrophy (GA), as Measured on Fundus Autofluorescence Imaging Using a Confocal Scanning Ophthalmoscope (HRA FAF) From Baseline to Year 2.|Geographic Atrophy (GA), or the death of photoreceptors and surrounding cells in the retina, is a common condition in patients with Age-Related Macular Degeneration (AMD). The death of these photoreceptors results in lesions that cause vision loss. The amount of GA is measured from images produced via a non-invasive technique called Fundus Autofluorescence Imaging, which uses a Confocal Scanning Ophthalmoscope to detect the naturally-fluorescing lipofuscin (the waste that is left behind by dead photoreceptors and digested by surrounding cells) that is prevalent at the border of the lesion.|2 years|"Data collected from the ten participants that completed the full twenty-four months of the study were analyzed.
Ten study eyes and ten fellow eyes were analyzed."||mm^2|Participants|Standard Deviation|Mean
720303|NCT00306488|Primary|The Change in Best-corrected Visual Acuity (BCVA) From Baseline to Year 2 for All Participants.|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. This acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters the Snellen measurement is 20/20.|2 years|"Data collected from the 10 participants that completed the 24-month follow-up visit were analyzed.
Ten study eyes and 10 fellow eyes were analyzed."||ETDRS Letters|Participants|Standard Deviation|Mean
720304|NCT00306527|Primary|Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine|To assess the safety and tolerability in terms of number of adult and elderly subjects reporting solicited adverse events following one dose of the cTIV or the TIV vaccine .|Day 1 to Day 7 postvaccination|This analysis was done on safety dataset||Participants|||Number
720305|NCT00306527|Secondary|Percentages of Adult and Elderly Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine.|"Immunogenicity was assessed in terms of percentages of adult and elderly subjects showing seroconversion or significant increase in HI antibody titers after one dose of cell culture-derived or the egg-derived influenza vaccine.
Seroconversion or significant increase as per European Licensure (CHMP) criteria is defined as percentage of subjects with a prevaccination HI titer <10 to a postvaccination titer ≥ 40 for adults and ≥ 30 for elderly. Significant increase is defined as percentage of subjects with a prevaccination HI titer ≥ 10 and a ≥ 4-fold increase in postvaccination HI antibody titer."|Day 22 postvaccination|This analysis was done on the immunogenicity subset.||Percentages of subjects||95% Confidence Interval|Number
720306|NCT00306527|Secondary|Percentages of Adult and Elderly Subjects Achieving HI Titers ≥ 40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine.|"Immunogenicity was assessed in terms of percentages of adult and elderly subjects achieving HI titers≥40,after one dose of either the cTIV vaccine or the TIV vaccine.
European (CHMP) criteria is met if the percentage of subjects achieving HI titers ≥ 40 is > 70% for adults and >60% for elderly."|Day 22 postvaccination|This analysis was done on immunogenicity subset.||Percentages of subjects||95% Confidence Interval|Number
720307|NCT00306527|Secondary|Geometric Mean Ratios (GMRs), After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects|"Immunogenicity was assessed in terms of GMR in adult and elderly subjects following one 0.5ml dose of either the cTIV vaccine or the TIV vaccine, according to the CHMP criteria.
The European licensure (CHMP) criteria was met if the mean geometric increase (GMR, day 22/day 1) in HI antibody titer is >2.5 for adults and >2.0 for elderly subjects."|Day 22 postvaccination|The analysis was done on the immunogenicity subset.||Ratio||95% Confidence Interval|Geometric Mean
720323|NCT00291551|Secondary|Change in NYHA Functional Class|"Change in NYHA functional class between baseline and 6 months. Maintained means the participant's functional class remains the same as baseline. Improved means the participant's functional class has improved (become lower in number) by at least one class. Worsened means the participatn's functional class has deteriorated (become higher in number) by at least one class."|Baseline to 6 months|per protocol||participants|||Number
720308|NCT00306527|Secondary|Geometric Mean Titers (GMTs) After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects|"The haemagglutinin inhibition (HI) antibody titer response following one 0.5 mL dose of either cell derived (cTIV) or egg-derived vaccine (TIV) in adult and elderly subjects is reported as GMTs.
The HI GMTs were evaluated using egg-derived antigen assay."|Day 22 postvaccination|The analysis was done on the immunogenicity subset.||Titers||95% Confidence Interval|Geometric Mean
720309|NCT00306527|Secondary|Six-months Safety Data of Subjects After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine|To collect additional safety data for 6 months after vaccination with one dose of cell culture derived or egg-derived influenza vaccine in terms of serious adverse events (SAEs), adverse events (AEs) necessitating a physician’s visit and/or resulting in premature subject’s withdrawal from study.|Upto 6 months postvaccination|This analysis was done on the safety dataset.||Participants|||Number
720310|NCT00306592|Primary|Number of Participants With Antibodies to Natalizumab|‘Positive with unknown persistence’ is defined as a positive result (≥0.5 micrograms/mL) at one timepoint only with no confirmatory re-test available at least 42 days later. ‘Transient positive’ is defined as a positive at one timepoint but negative upon re-test at least 42 days later. ‘Persistent positive’ is defined as positive at 2 or more timepoints separated by at least 42 days. The threshold for classifying a sample as 'antibody positive' was set at the lowest level of reactivity that had a measurable impact on drug serum concentrations.|Baseline (Week 0), Week 4, Week 24 (test was repeated after 8 weeks if positive, to confirm persistence)|All participants who received at least 1 dose of natalizumab, had a negative baseline antibody result, and had at least 1 antibody result after the first dose.||participants|||Number
720311|NCT00306592|Primary|Number of Participants With Hypersensitivity-related Adverse Events|For purposes of this analysis, the terms 'hypersensitivity' and 'drug hypersensitivity' were categorized by their temporal relationship to study drug infusion (within 2 hours of the start of the infusion), and were considered equivalent. Hypersensitivity reactions are defined as infusion reactions with the following preferred terms: hypersensitivity not otherwise specified (NOS), anaphylactic reaction, anaphylactoid reaction, dermatitis allergic, drug hypersensitivity, urticaria NOS, vasoconstriction, urticaria generalised, hypersensitivity, urticaria.|Baseline through Week 48|Participants receiving at least 1 dose of study drug||participants|||Number
720312|NCT00306592|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious AEs (SAEs)|AEs: any sign, symptom, or diagnosis/disease that is unfavorable or unintended, that is new, or if pre-existing, worsens in participants administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. SAEs: an event that results in death; an event that, in the view of the investigator, places the participant at immediate risk of death (a life-threatening event); an outcome that results in a congenital anomaly/birth defect diagnosed in a child of a participant; an event that requires or prolongs inpatient hospitalization; an event that results in persistent or significant disability/incapacity. Any other medically important event that, in the opinion of the investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above. Treatment-emergent AEs: events in participants who had received at least 1 dose of study drug, regardless of relationship to study drug.|Baseline through Week 48|Participants receiving at least 1 dose of study drug||participants|||Number
720313|NCT00306670|Primary|To Evaluate the Total Number of Circulating Lymphocytes and Lymphocyte Phenotypes and to Correlate With the Effectiveness of Rituximab and Oral Cyclophosphamide to Achieve and Preserve Complete Eradication of the Refractory Autoantibody.|the 2 recruited patients did not eradicate their inhibitors with 3 weeks of corticosteroids and did not progress in clinical trial since funding was eliminated and study terminated|When 25 patients have completed the study.|2 patients with acquired hemophilia A: two patients were recruited, but the sponsor terminated the study before the patients started treatment||Participants|||Count of Participants
720314|NCT00291551|Secondary|Number of Participants Who Died|Total number of patient deaths reported prior to study closure|Study duration|per protocol||participants|||Number
720315|NCT00291551|Secondary|Number of Adverse Events|Total adverse events reported prior to study closure|Study duration|per protocol||events|||Number
720316|NCT00291551|Secondary|Mean Changes in Overall Minnesota Living With Heart Failure (MLHF) Quality of Life Questionnaire Score|The MLHF Quality of Life (QOL) Questionnaire evaluates the effects of heart failure on a subject's physical, emotional, social and mental dimensions of quality of life. Each of 21 questions is scored as to how much heart failure has impacted the subject, from 0-no impact to 5-very much (overall score can range from 0 to 105). Prior studies have shown a 10-point improvement (10-point decrease in overall score) correlated with a 1 NYHA class improvement, and 10-point worsening (10-point increase in score) was associated with a higher risk of hospitalization or death.|Baseline to 6 months|per protocol||score on a scale||Standard Deviation|Mean
720317|NCT00291551|Secondary|Changes in Cardiopulmonary Tests|Mean change in Peak VO2 (ml/kg/min) between baseline and 6 months|Baseline to 6 months|per protocol||ml/kg/min||Standard Deviation|Mean
720318|NCT00291551|Secondary|Changes in 6 Minute Walk|Mean change in 6 minute walk distance (meters) between baseline and 6 months|Baseline to 6 months|per protocol||meters||Standard Deviation|Mean
720319|NCT00291551|Secondary|Change in Left Ventricular Mass|Mean change in left ventricular mass from baseline to 6 months (echocardiogram measurements)|Baseline to 6 months|||grams||Standard Deviation|Mean
720320|NCT00291551|Secondary|Change in Left Ventricular Ejection Fraction|Mean change in left ventricular ejection fraction from baseline to 6 months (echocardiographic measurements)|Baseline to 6 months|per protocol||Percentage||Standard Deviation|Mean
720321|NCT00291551|Secondary|Changes in Left Ventricular Volumes|Mean change in left ventricular end-diastolic volume (LVEDv) and left ventricular end-systolic volume (LVESV) from baseline to 6 months (echocardiographic measurements)|Baseline to 6 months|per protocol||milliliters||Standard Deviation|Mean
720322|NCT00291551|Secondary|Changes in Left Ventricular Diameters|Mean change in left ventricular end-diastolic diameter (LVEDD) and left ventricular end-systolic diameter (LVESD) from baseline to 6 months (echocardiographic measurements)|Baseline to 6 months|per protocol||centimeters||Standard Deviation|Mean
720324|NCT00291551|Secondary|Implant Success (Number of Participants Successfully Implanted)|"Implant success refers to the ability to successfully deliver a device onto the epicardial surface and leave the device in a satisfactory position."|1 day|per protocol||participants|||Number
720327|NCT00291577|Primary|Area Under the Curve From Time 0 to Last Quantifiable Concentration (AUClast): Docetaxel PK Parameters|Mean AUClast = area under the plasma concentration-time profile from time 0 (predose) to the last measurable concentration; collected C1D1, C2D1. Paired observation.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose|Evaluable set of subjects for PK analysis||ng*hr/mL||Standard Deviation|Mean
720328|NCT00291577|Primary|Area Under the Curve From Time 24 Hours to 48 Hours (AUC24_48) : Docetaxel PK Parameters|Mean AUC24_48 = area under the plasma concentration-time profile from 24 to 48 hours; collected C1D1, C2D1. Paired observation.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose|Evaluable set of subjects for PK analysis||ng*hr/mL||Standard Deviation|Mean
720329|NCT00291577|Primary|Area Under the Plasma Concentration-time Curve From Time Zero (0) to 48 Hours (AUC48): Docetaxel PK Parameters|Mean AUC48 = area under the plasma concentration-time profile from time 0 to 48 hours; collected C1D1, C2D1. Paired observation.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose|Evaluable set of subjects for PK analysis||ng*hr.mL||Standard Deviation|Mean
720330|NCT00291577|Secondary|Duration of Tumor Response Based on Investigator Assessment|Median duration (50%) of tumor response based on Investigator assessment for a subgroup of subjects with objective disease response: who have not progressed or died due to any cause; with a response and subsequent progression or death due to any cause for duration of response (DR). DR defined as time from start of first documented objective tumor response (CR or PR) to first documented objective tumor progression or death due to any cause, whichever occurs first. DR calculated as (Weeks) = (the end date for DR minus first subsequent confirmed CR or PR plus 1) divided by 7.|Start of first confirmed CR or PR to first confirmed progression or death|ITT; subgroup of subjects with objective disease response||weeks||95% Confidence Interval|Median
720331|NCT00291577|Secondary|Number of Subjects With Clinical Benefit of Complete Response, Partial Response, or Stable Disease Based on Investigator Assessment|Number of subjects with clinical benefit based on Investigator assessment of confirmed complete response (CR), partial response (PR), or stable disease (SD) according to RECIST for at least 24 weeks on study.|First dose of study treatment until at least 24 weeks on study|ITT; subjects with baseline assessments||participants|||Number
720332|NCT00291577|Secondary|Number of Subjects With Objective Response of Complete Response or Partial Response Based on Investigator Assessment|Number of subjects with objective response based on Investigator assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response.|First dose of study treatment until at least 4 weeks after confirmed response or partial response|ITT; subjects with baseline assessments||participants|||Number
720333|NCT00291577|Secondary|Progression-Free Survival (PFS) Based on Investigator Assessment|Median time (50 percent [%]) from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first; based on Investigator assessment. PFS calculated as (Weeks) = (first event date minus first dose date plus 1) divided by 7.|First dose of study treatment until progressive disease|ITT population = all subjects enrolled in study who received at least 1 dose of study medication (SU011248 or docetaxel).||weeks||95% Confidence Interval|Median
720334|NCT00291577|Primary|Area Under the Plasma Concentration-time Curve From Time Zero (0) to 24 Hours (AUC24): Docetaxel PK Parameters|Mean AUC24 = area under the plasma concentration-time profile from time 0 to 24 hours; collected C1D1, C2D1. Paired observation.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose|Evaluable set of subjects for PK analysis||ng*hr/mL||Standard Deviation|Mean
720335|NCT00291577|Primary|Maximum Observed Plasma Concentration (Cmax): Docetaxel PK Parameters|Mean Cmax = maximum plasma concentration for Docetaxel; collected C1D1, C2D1. Paired observation; Cmax dose corrected (dose correction if predose concentrations of SU011248 or SU012662 were > 5% of Cmax).|0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose|Evaluable set of subjects for PK analysis||ng/mL||Standard Deviation|Mean
720336|NCT00291577|Primary|Time to Reach Maximum Plasma Concentration (Tmax): Docetaxel PK Parameters|Median Tmax = time to maximum plasma concentration (Cmax) for Docetaxel; collected C1D1, C2D1. Paired observation.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose|Evaluable set of subjects for PK analysis||hours||Full Range|Median
720337|NCT00291577|Primary|Trough Plasma Concentration (Ctrough) at Time Zero (0): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters|Mean Ctrough=plasma concentration-time profile at time 0 (predose); collected C1D2, C1D15, and C2D1. Calculated by setting concentration values below the limit of quantification to zero.|0 hour postdose|Evaluable set of subjects for PK analysis; (n) = Number of observations above lower limit of quantification (NALQ). No participants analyzed for SU011248 C1D2 and SU012662 C1D2; standard deviation for Total drug C1D2 confirmed as 0.00 (median, minimum, and maximum = 0.20).||ng/mL||Standard Deviation|Mean
720338|NCT00291577|Primary|Area Under the Curve From Time 0 to Last Quantifiable Concentration (AUClast): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters|Mean AUClast = area under the plasma concentration-time profile from time 0 (predose) to the last measurable concentration; collected C1D2, C2D3. Data did not allow calculation of AUClast; not summarized; AUC summarized in outcome measure: Area under the plasma concentration-time curve from time zero (0) to 24 hours (AUC24): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters.|1, 2, 4, 6, 8, 12, 24 hours postdose|Evaluable set of subjects for PK analysis||ng*hr/mL||Standard Deviation|Mean
720339|NCT00291577|Primary|Area Under the Plasma Concentration-time Profile From Time Zero (0) to 24 Hours (AUC24): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters|Mean AUC24 = area under plasma concentration-time profile from time 0 to 24 hours for SU011248, SU012662, and combined SU011248 and SU012662 (total drug) measured in nanograms times hour per milliliter (ng*hr/mL); collected C1D2, C2D3. Paired observation; AUC24 dose corrected C2D3 (dose correction if predose concentrations of SU011248 or SU012662 were > 5% of Cmax).|1, 2, 4, 6, 8, 12, 24 hours postdose|Evaluable set of subjects for PK analysis||ng*hr/mL||Standard Deviation|Mean
720340|NCT00291577|Primary|Maximum Observed Plasma Concentration (Cmax): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters|Mean Cmax = maximum plasma concentration for SU011248, SU012662, and combined SU011248 and SU012662 (total drug) measured as nanograms per milliliter (ng/mL); collected C1D2, C2D3. Paired observation; Cmax dose corrected C2D3 (dose correction if predose concentrations of SU011248 or SU012662 were > 5% of Cmax).|1, 2, 4, 6, 8, 12, 24 hours postdose|Evaluable set of subjects for PK analysis||ng/mL||Standard Deviation|Mean
720341|NCT00291577|Primary|Time to Reach Maximum Plasma Concentration (Tmax): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters|Median Tmax = time for maximum plasma concentration (Cmax) for SU011248, SU012662, and combined SU011248 and SU012662 (total drug); collected C1D2, C2D3. Paired observation.|1, 2, 4, 6, 8, 12, 24 hours postdose|Evaluable set of subjects for PK analysis is subjects in ITT population who completed sampling for PK profiles for both SU011248 and docetaxel; ITT population = all subjects enrolled in study who received at least 1 dose of study medication (SU011248 or docetaxel).||hours||Full Range|Median
720342|NCT00291655|Secondary|Change From Baseline in Body Weight to Withdrawal or End of Study After 18 Months||Start of open-label therapy (Baseline) to withdrawal or end of study after 18 months|Subjects with a discontinuation visit||kg||Standard Deviation|Mean
720343|NCT00291655|Primary|Assessment of Safety of Levetiracetam as Per Adverse Event (AE) Reporting in Open-label Therapy Phase|Summarization for occurrence of adverse events like number of subjects with any adverse events or drug related adverse events is provided (see categories).|during open-label therapy phase of 18 months|Safety population that includes all subjects that have been treated once.||participants|||Number
720344|NCT00291694|Secondary|Molecular Ratio of Serum Concentration of IGF-1 to IGFBP3|Change ion ratio.|baseline to 12 months|||ratio||Standard Error|Median
720345|NCT00291694|Secondary|Serum Sex Hormone Binding Globulin (SHBG) Concentration|Change in serum concentration|Baseline to 12 months|||nmol/L||Standard Error|Median
720346|NCT00291694|Secondary|Serum Estradiol Concentration|Change in serum estradiol concentration|Baseline to 12 months|||pg/ml||Standard Error|Median
720347|NCT00291694|Secondary|Mammographic Breast Density|The percent of mammographic breast area that is considered to be at increased density. Evaluated using the semi-automated computer program Cumulus.|Baseline and 12 months|Subjects completing 12 months, with baseline and 12 month mammograms suitable for density analysis, such that a change in density over time can be computed||percentage of breast area at increased d||Standard Error|Median
720348|NCT00291694|Primary|Change in Percent of Breast Epithelial Cells Staining Positive for Ki-67|Immunocytochemical staining of breast epithelial cells. Positive cells reflect proliferative activity.|Baseline and 12 months|||percentage of cells staining positive||Full Range|Median
720349|NCT00291876|Secondary|Number of Subjects Reporting Pregnancies After Additional Vaccination|The number of subjects with outcome of pregnancies reported among subjects who had received the additional vaccination was tabulated. 4 subjects received additional vaccination at Month 186 and 1 subject at Month 198.|At Months 186 and 198|Analysis was performed on the Long Term Total cohort, only on subjects who received an additional vaccine dose during the current long-term follow-up study. If a subject became seronegative (< 15 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose.||Subject|||Number
720350|NCT00291876|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE) After Additional Vaccination|"An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
4 subjects received additional vaccination at Month 186 and 1 at Month 198."|During the 30-day follow-up period after additional vaccination|Analysis was performed on the Long Term Total cohort, only on subjects who received an additional vaccine dose during the current long-term follow-up study. If a subject became seronegative (< 15 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose.||subjects|||Number
720351|NCT00291876|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE) Assessed by the Investigator as Related to Primary Study Vaccination, Procedures or Lack of Vaccine Efficacy|An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above|At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246|Analysis was performed on the Long Term Total cohort, on subjects with available data for the defined timepoint.||Subjects|||Number
720352|NCT00291876|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|"An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
4 subjects received additional vaccination at Month 186 and 1 at Month 198."|During the 30-day follow-up period after additional vaccination|Analysis was performed on the Long Term Total cohort, only on subjects who received an additional vaccine dose during the current long-term follow-up study. If a subject became seronegative (< 15 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose.||subjects|||Number
720353|NCT00291876|Secondary|Number of Subjects Reporting Solicited General Symptoms|"Solicited general symptoms assessed include fatigue, fever, gastrointestinal symptoms and headache.
4 subjects received additional vaccination at Month 186 and 1 subject at Month 198."|During the 4-day (Days 0-3) follow-up period after additional vaccination|Analysis was performed on the Long Term Total cohort, only on subjects who received an additional vaccine dose during the current long-term follow-up study. If a subject became seronegative (< 15 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose.||subjects|||Number
720354|NCT00291876|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling. Additional vaccination was given to 4 subjects at the Month 186 timepoint and to 1 subject at the Month 198 timepoint.|During the 4-day (Days 0-3) follow-up period after additional vaccination|Analysis was performed on the Long Term Total cohort, only on subjects who received an additional vaccine dose during the current long-term follow-up study. If a subject became seronegative (< 15 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose.||subjects|||Number
720355|NCT00291876|Secondary|Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration|"Concentrations given as GMC expressed as mIU/mL. 4 subjects received additional vaccination at Month 186 and 1 subject at Month 198.
Please note that value 14.9 means <15."|Before additional vaccination, 14 days after additional vaccination and 30 days after additional vaccination|Analysis was performed on the Long Term Total cohort, only on subjects who received an additional vaccine dose during the current long-term follow-up study. If a subject became seronegative (< 15 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose.||mIU/mL|||Number
720356|NCT00291876|Primary|Number of Seropositive Subjects Against Hepatitis A Virus|A seropositive subject was a vaccinated subject whose concentrations for antibodies against hepatitis A virus (anti-HAV) were equal or above (>=) the assay cut-off for seropositivity of 15 milli-international units per milliliter (mIU/mL). ** = Regarding Month 234 data, please note that there were 5 subjects for whom serum sample tube was broken and thus due to risk of contamination the test were not performed. Hence these subjects were not included in the LT-ATP cohort for immunogenicity analysis at Month 234. $ = Regarding Month 246 data, please note there was 1 subject for whom serum sample tube was broken and hence scrapped by laboratory. Hence this subject was not included in the LT-ATP cohort for immunogenicity analysis at Month 246.|At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246|Analysis was performed on the Long Term According-to-Protocol (LT-ATP) cohort for analysis of immunogenicity, on subjects with available data for the defined timepoint. *The laboratory assay was changed at Month 138, thus the blood samples were re-tested with the old assay for the sake of bridging.||Subjects|||Number
720357|NCT00291876|Primary|Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration|Concentrations given as geometric mean concentration (GMC) expressed as milli-international unit per millilitre (mIU/mL). ** = Regarding Month 234 data, please note that there were 5 subjects for whom serum sample tube was broken and thus due to risk of contamination the test were not performed. Hence these subjects were not included in the LT-ATP cohort for immunogenicity analysis at Month 234. $ = Regarding Month 246 data, please note there was 1 subject for whom serum sample tube was broken and hence scrapped by laboratory. Hence this subject was not included in the LT-ATP cohort for immunogenicity analysis at Month 246.|At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246|"Analysis was performed on the Long Term According-to-Protocol (LT-ATP) cohort for analysis of immunogenicity, on subjects with available data for the defined timepoint.
* The laboratory assay was changed at Month 138, thus the blood samples were re-tested with the old assay for the sake of bridging."||mIU/mL||95% Confidence Interval|Geometric Mean
720358|NCT00297427|Secondary|Pelvic Floor Muscle Strength|Change in average duration of pelvic floor muscle contraction measured by electromyography. Subjects were instructed to tighten their pelvic floor muscles when prompted and hold the contraction until told to relax (up to 10 seconds). This was repeated three times and the duration of the contraction time was averaged.|Baseline and 4 weeks post true or sham acupuncture|||seconds||Standard Deviation|Mean
720359|NCT00297427|Secondary|Pelvic Floor Muscle Strength|Change in average duration of pelvic floor muscle contraction measured by electromyography. Subjects were instructed to tighten their pelvic floor muscles when prompted and hold the contraction until told to relax (up to 10 seconds). This was repeated three times and the duration of the contraction time was averaged.|Baseline and 1 week post true or sham acupuncture|||seconds||Standard Deviation|Mean
720360|NCT00297427|Secondary|Response to Booster Acupuncture if Needed|Change in the number of incontinent episodes per day following booster acupuncture|After the booster sessions|Participants who received booster acupuncture treatments during follow-up||incontinent episodes/day||Standard Deviation|Mean
720361|NCT00297427|Secondary|Need for Booster Acupuncture During Follow-up|The number of participants who were received true acupuncture (as their initial intervention or after initially receiving sham acupuncture) and were eligible to receive a booster (had a 50% or greater reduction in incontinent episodes following true acupuncture) and completed at least one month of follow-up and experienced a 30% or greater increase in incontinent episodes during follow up.|Monthly during the 6 month follow-up period|Participants who completed true acupuncture (as either their initial treatment or following sham acupuncture), had a 50% or greater reduction in incontinent episodes at 1 or 4 weeks post-true acupuncture, and completed at least one month of follow-up.||participants|||Number
720362|NCT00297427|Secondary|Burden Associated With the Acupuncture Treatment Protocol|Subjects' report of burden (difficulty) associated with the frequency, number and duration of treatment) and the position they had to remain in during the true and sham treatments. Subjects rate the difficulty associated with each of the four aspects of treatment on a 10-point scale ranging from 1 (not at all difficult) to 10 (extremely difficult). The burden score was calculated as the average of the scores on the 4 items with a possible range of 1 to 10 with higher scores indicating greater burden.|1 week post-treatment|The number of participants analyzed for this outcome was only those who completed the treatment protocol and the 1-week post-treatment visit. For this reason, the number is smaller than the number for the primary outcomes||units on a scale||Inter-Quartile Range|Median
720363|NCT00297427|Secondary|Adherence to Treatment Protocol|Percentage of acupuncture (true or sham) visits completed as scheduled|6 weeks|True and sham acupuncture subjects who completed the 6 weeks of treatment; participants who dropped out of the study during treatment were not included in this analysis||percent of visits||Standard Deviation|Mean
720364|NCT00297427|Secondary|Characteristics of Responders: Duration of Urinary Incontinence (UI) in Years|Duration of urinary incontinence in years|Baseline|Responders were subjects who achieved a 50% reduction in urinary incontinent episodes by 4 weeks post true acupuncture (as their initial or relayed intervention)||years||Standard Deviation|Mean
720365|NCT00297427|Secondary|Characteristics of Responders Based on Glasses/Cups Per Day of Non-caffeinated Fluids (Including Water)|Glasses/cups per day of non-caffeinated fluids (including water) at baseline|Baseline|Responders were subjects who achieved a 50% reduction in urinary incontinent episodes by 4 weeks post true acupuncture (as their initial or relayed intervention)||Glasses/cups per day||Standard Deviation|Mean
720366|NCT00297427|Secondary|Urodynamic Impression of Urge Urinary Incontinence|Documentation of a diagnostic impression of urge urinary incontinence following urodynamics|Baseline and 4 weeks post true or sham acupuncture|||participants|||Number
720367|NCT00297427|Secondary|Urodynamic Diagnostic Impression of Stress Urinary Incontinence|Documentation of a diagnostic impression of stress urinary incontinence following urodynamics|Baseline and 4 weeks post-treatment|||participants|||Number
720368|NCT00297427|Secondary|Change in Bladder Capacity|Measured by filling the bladder with sterile fluid until until the subject reported a strong urge to urinate.|Change from baseline to 4 weeks post-intervention|Subjects who agreed to have a cystometrogram at baseline and 4 weeks after completing acupuncture or sham acupuncture.||milliliters||Standard Deviation|Mean
720369|NCT00297427|Primary|Duration of Any Beneficial Effects|Time to relapse in months of participants who completed true acupuncture initially or who crossed-over following sham (offered to all sham participants)|monthly during follow-up up to 6 months|Subjects who received true acupuncture and completed at least a 1-month follow-visit post acupuncture||Months||Standard Error|Mean
720371|NCT00297427|Primary|Incontinence-Specific Quality of Life|Percent change in incontinence specific quality of life at 1 week post intervention (true or sham acupuncture) as measured by the Incontinence Impact Questionnaire. Positive values indicate improvement in incontinence-specific quality of life.|1 Week post-intervention|Intention-to-treat analysis||percentage change relative to baseline||Inter-Quartile Range|Median
720372|NCT00297427|Primary|Mental Health Related Quality of Life|Percent change in mental health related quality of life measured at 4 weeks post intervention (true or sham acupuncture) relative to baseline; measured by the Medical Outcomes Study Short Form-36 (SF-36) Mental Health Component score.|4 weeks post true or sham acupuncture|Intention-to-treat||percentage change relative to baseline||Inter-Quartile Range|Median
720373|NCT00297427|Primary|Mental Health Related Quality of Life|Percent change in mental health related quality of life measured at 1 week1 post intervention (true or sham acupuncture) relative to baseline; measured by the Medical Outcomes Study Short Form-36 (SF-36) Mental Health Component score. Higher Mental Health Component scores are considered a better outcome.|1 week post-intervention|Intention to treat analysis||percentage change relative to baseline||Inter-Quartile Range|Median
720374|NCT00297427|Primary|Physical Health-Related Quality of Life|Percent change in physical health related quality of life measured at 4 weeks post intervention (true or sham acupuncture) relative to baseline; measured by the Medical Outcomes Study Short Form-36 (SF-36) Physical Component score. Positive change indicates an increase in physical health-related quality of life.|4-weeks post-intervention|Intention-to-treat||percentage change relative to baseline||Inter-Quartile Range|Median
720375|NCT00297427|Primary|Physical Health-Related Quality of Live|Percent change in physical health related quality of life measured at 1 week post-intervention (true or sham acupuncture) relative to baseline; measured by the Medical Outcomes Study Short Form-36 (SF-36) Physical Component score. Higher SF-36 Physical Component scores are considered a better outcome.|1 Week post-intervention|Intention-to-treat||percentage change relative to baseline||Inter-Quartile Range|Median
720376|NCT00297427|Primary|Percent Change in Incontinent Episodes|Percent change in incontinent episodes (measured by self-report electronic bladder diary) 4 weeks post true or sham acupuncture|4 weeks post true or sham acupuncture|Intention-to-treat analysis||percent change in incontinent episodes||Standard Deviation|Mean
720377|NCT00297427|Primary|Percent Change in Incontinent Episodes|Percent change in incontinent episodes (measured by self-report electronic bladder diary) at 1 week post-intervention (true or sham acupuncture) relative to baseline.|Baseline to 1 Week post-intervention|Intention-to-treat||percent change in incontinent episodes||Standard Deviation|Mean
720378|NCT00297492|Primary|Number of Participants With Prolonged Abstinence Through 6 Months Verified by Carbon Monoxide Measurement|Number of participants with self-reported prolonged abstinence from cigarette smoking through 6 months of follow-up, verified by a breath carbon monoxide reading of less than 10 parts per million|6 months|This was an intent-to-treat analysis. Those who were lost to follow-up were assumed to not be abstinent from smoking at the time of the 6 month follow-up.||participants|||Number
720379|NCT00297596|Secondary|Time to Progression||18 months||||||
720380|NCT00297596|Primary|Objective Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|18 months|||percentage of participants||95% Confidence Interval|Number
720381|NCT00297648|Secondary|Change From Baseline in Crohn's Disease Activity Index (CDAI) Score at Week 54|Crohn’s disease activity index (CDAI) responders are patients achieving clinical response (a reduction in CDAI score of at least 100 points from Baseline). CDAI is used to quantify the symptoms of Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Baseline, Week 54|Of the 89 patients in the Intent to Treat Population, 39 had CDAI scores at Week 54 and Baseline and are included in this summary. Change from Baseline has been calculated as the Week 54 score minus the Baseline score, thus a negative Change from Baseline indicates improvement.||score on a scale||Standard Deviation|Mean
720382|NCT00297648|Secondary|Change From Baseline in Crohn's Disease Activity Index (CDAI) Score at Week 10|Crohn’s disease activity index (CDAI) responders are patients achieving clinical response (a reduction in CDAI score of at least 100 points from Baseline). CDAI is used to quantify the symptoms of Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Baseline, Week 10|Of the 89 patients in the Intent to Treat Population, 73 patients had data at both Baseline and Week 10, and are included in this summary. Change from Baseline has been calculated as the Week 10 score minus the Baseline score, thus a negative Change from Baseline indicates improvement.||score on a scale||Standard Deviation|Mean
720383|NCT00297648|Secondary|Change From Baseline in Crohn’s Disease Endoscopic Index of Severity (CDEIS) Score at Week 54 Using Central Blinded Assessment|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.|Baseline, Week 54|Of 89 patients in the Intent to Treat Population, 28 had matching nonblinded/blinded assessments and were in the subpopulation with a blinded assessment at Week 54 and Baseline. Change from Baseline has been calculated as the Week 54 score minus the Baseline score, thus a negative Change from Baseline indicates improvement.||score on a scale||Standard Deviation|Mean
720384|NCT00297648|Secondary|Change From Baseline in Crohn’s Disease Endoscopic Index of Severity (CDEIS) Score at Week 54 Using Local Non-blinded Assessment|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.|Baseline, Week 54|Of the 89 patients in the Intent to Treat Population, 52 had a CDEIS score at Week 54 and at Baseline and are included here. Change from Baseline has been calculated as the Week 54 score minus the Baseline score, thus a negative Change from Baseline indicates improvement.||score on a scale||Standard Deviation|Mean
720542|NCT00311766|Secondary|Number of Participants Whose Wounds Have Healed|Wound healing means that the wound has closed without any drainage|56 days|The population for efficacy analysis will be the Full Analysis (FA) population. The FA analysis included all patients who were randomized and received at least one dose of study medication and who had at least one baseline efficacy parameter recorded.||participants|||Number
720385|NCT00297648|Secondary|Correlation Between Mean C-Reactive Protein (CRP) Plasma Level and Histological Crohn's Disease Score at Week 10 Using Central Blinded Assessment|The histological Crohn’s disease score combines active inflammatory changes: infiltration of mononuclear cells, polymorphonuclear cells, presence of erosions and/or ulcers, and chronic architectural changes. Scores range from 0 to 44, with higher scores indicating greater disease|Week 10|Of the 89 patients in the Intent to Treat Population, 72 patients had plasma data and histological Crohn's disease score assessment at Week 10, and are included in this summary.||Pearson Correlation Coefficient||95% Confidence Interval|Number
720386|NCT00297648|Secondary|Correlation Between Mean C-Reactive Protein (CRP) Plasma Level and Crohn’s Disease Endoscopic Index of Severity (CDEIS) Score at Week 10 Using Central Blinded Assessment|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.|Week 10|Of the 89 patients in the Intent to Treat Population, 51 patients were in the subpopulation with a blinded assessment at Week 10. 48 patients had both CDEIS and CRP data at Week 10.||Pearson Correlation Coefficient||95% Confidence Interval|Number
720387|NCT00297648|Secondary|Correlation Between Mean C-Reactive Protein (CRP) Plasma Level and Crohn’s Disease Endoscopic Index of Severity (CDEIS) Score at Week 10 Using Local Non-blinded Assessment|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.|Week 10|Of the 89 patients in the Intent to Treat Population, 76 patients had plasma level data and a CDEIS score at Week 10 and are included in this summary.||Pearson Correlation Coefficient||95% Confidence Interval|Number
720388|NCT00297648|Secondary|Correlation Between Mean C-Reactive Protein (CRP) Plasma Level and Crohn's Disease Activity Index (CDAI) Score at Week 10|Crohn’s disease activity index (CDAI) responders are patients achieving clinical response (a reduction in CDAI score of at least 100 points from Baseline). CDAI is used to quantify the symptoms of Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 10|Of the 89 patients in the Intent to Treat Population, 73 patients had plasma level data and a CDAI score at Week 10 and are included in this summary.||Pearson Correlation Coefficient||95% Confidence Interval|Number
720389|NCT00297648|Secondary|Ratio to Baseline of C-Reactive Protein (CRP) Level (mg/L) at Week 52|The ratio is calculated as the Week 52 value divided by Baseline value for patients with data at both timepoints.|Baseline, Week 52|Of the 89 patients in the Intent to Treat Population, 51 patients had plasma level data at Week 54 and Baseline and are included in this summary. Ratio was calculated by dividing the Week 54 value by the Baseline value for the patients with data at both timepoints.||ratio||Full Range|Geometric Mean
720390|NCT00297648|Secondary|Geometric Mean C-Reactive Protein (CRP) Level (mg/L) at Week 52||Week 52|Of the 89 patients in the Intent to Treat Population, 51 patients had plasma level data at Week 54 and are included in this summary.||mg/L||Full Range|Geometric Mean
720391|NCT00297648|Secondary|Ratio to Baseline of C-Reactive Protein (CRP) Level (mg/L) at Week 10|Ratio is calculated as the Week 10 value divided by the Baseline value for patients with data at both timepoints.|Baseline, Week 10|Of the 89 patients in the Intent to Treat Population, 76 patients had plasma levels taken at Week 10 and Baseline and are included in this summary. Ratio is calculated as the Week 10 value divided by the Baseline value for patients with data at both timepoints.||ratio||Full Range|Geometric Mean
720392|NCT00297648|Secondary|Geometric Mean C-Reactive Protein (CRP) Level (mg/L) at Week 10||Week 10|Of the 89 patients in the Intent to Treat Population, 76 patients had plasma level data at Week 10 and are included in this summary.||mg/L||Full Range|Geometric Mean
720393|NCT00297648|Secondary|Percentage of Patients Achieving Crohn's Disease Activity Index (CDAI) Remission (Defined as a CDAI Score Less Than or Equal to 150) at Week 54|Crohn’s disease activity index (CDAI) responders are patients achieving clinical response (a reduction in CDAI score of at least 100 points from Baseline). CDAI is used to quantify the symptoms of Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 54|The 89 patients from Intent to Treat Population are included in this summary. In case of missing CDAI score, patients are counted as remitters. Percentage is calculated by dividing the number of patients with a CDAI less than or equal to 150 points at Week 54 by the total number of patients in the Intent to Treat Population, multiplied by 100.||percentage of patients||95% Confidence Interval|Number
720394|NCT00297648|Secondary|Percentage of Patients Achieving Crohn's Disease Activity Index (CDAI) Remission (Defined as a CDAI Score Less Than or Equal to 150) at Week 10|Crohn’s disease activity index (CDAI) responders are patients achieving clinical response (a reduction in CDAI score of at least 100 points from Baseline). CDAI is used to quantify the symptoms of Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 10|The 89 patients from Intent to Treat Population are included in this summary. In case of missing CDAI score, patients are counted as remitters. Percentage is calculated by dividing the number of patients with a CDAI less than or equal to 150 points at Week 10 by the total number of patients in the Intent to Treat Population, multiplied by 100.||percentage of patients||95% Confidence Interval|Number
720395|NCT00297648|Secondary|Percentage of Patients Achieving Crohn's Disease Activity Index (CDAI) Response (Defined as a Decrease of at Least 100 Points in CDAI Score From Baseline) at Week 54|Crohn’s disease activity index (CDAI) responders are patients achieving clinical response (a reduction in CDAI score of at least 100 points from Baseline). CDAI is used to quantify the symptoms of Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Baseline, Week 54|The 89 patients from Intent to Treat Population are included in this summary. In case of missing CDAI score, patients are counted as non-responders. Percentage is calculated by dividing the number of patients with a CDAI decrease of at least 100 points at Week 54 by the total number of patients in the Intent to Treat Population, multiplied by 100.||percentage of patients||95% Confidence Interval|Number
720414|NCT00297648|Secondary|Percentage of Patients Achieving Mucosal Healing at Week 10 Using Central Blinded Assessments|Mucosal healing is defined as complete absence of ulceration contribution in the CDEIS (Crohn's Disease Endoscopic Index of Severity) score|Week 10|Of the 89 patients in the Intent to Treat Population, 51 patients were in the subpopulation who had a blinded assessment at Week 10 and are included here. Percentage of patients is calculated by dividing the number of patients who achieved mucosal healing at Week 10 by the total number of patients with data collected, multiplied by 100.||percentage of patients||95% Confidence Interval|Number
720396|NCT00297648|Secondary|Percentage of Patients Achieving Crohn's Disease Activity Index (CDAI) Response (Defined as a Decrease of at Least 100 Points in CDAI Score From Baseline) at Week 10|Crohn’s disease activity index (CDAI) responders are patients achieving clinical response (a reduction in CDAI score of at least 100 points from Baseline). CDAI is used to quantify the symptoms of Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Baseline, Week 10|The 89 patients from Intent to Treat Population are included in this summary. In case of missing CDAI score, patients are counted as non-responders. Percentage is calculated by dividing the number of patients with a CDAI decrease of at least 100 points at Week 10 by the total number of patients in the Intent to Treat Population, multiplied by 100.||percentage of patients||95% Confidence Interval|Number
720397|NCT00297648|Secondary|Change From Baseline in Histological Crohn's Disease Score at Week 54 Using Central Blinded Assessment|The histological Crohn’s disease score combines active inflammatory changes: infiltration of mononuclear cells, polymorphonuclear cells, presence of erosions and/or ulcers, and chronic architectural changes. Scores range from 0 to 44, with higher scores indicating greater disease.|Baseline, Week 54|Of the 89 patients in the Intent to Treat Population, 52 patients had data at Week 54 and at Baseline for blinded assessment, and are included in this summary. Change from Baseline has been calculated as the Week 54 score minus the Baseline score, thus a negative Change from Baseline indicates improvement.||score on a scale||Standard Deviation|Mean
720398|NCT00297648|Secondary|Change From Baseline in Histological Crohn's Disease Score at Week 10 Using Central Blinded Assessment|The histological Crohn’s disease score combines active inflammatory changes: infiltration of mononuclear cells, polymorphonuclear cells, presence of erosions and/or ulcers, and chronic architectural changes. Scores range from 0 to 44, with higher scores indicating greater disease.|Baseline, Week 10|Of the 89 patients in the Intent to Treat Population, 75 patients had data at Week 10 and at Baseline for the blinded assessment, and are included in this summary. Change from Baseline has been calculated as the Week 10 score minus the Baseline score, thus a negative change from Baseline indicates improvement.||score on a scale||Standard Deviation|Mean
720399|NCT00297648|Secondary|Percentage of Patients With Endoscopic Complete Remission (Crohn’s Disease Endoscopic Index of Severity (CDEIS) Score Below 3) at Week 54 Using Central Blinded Assessments|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.|Week 54|Of 89 patients in the Intent to Treat Population, 28 had matching nonblinded/blinded assessments and were in the subpopulation with a blinded assessment at Week 54 and Baseline. Percentage is calculated by dividing the number of patients with a CDEIS score <3 at Week 54 by the total number of patients with CDEIS data at Week 54, multiplied by 100.||percentage of patients||95% Confidence Interval|Number
720400|NCT00297648|Secondary|Percentage of Patients With Endoscopic Complete Remission (Crohn’s Disease Endoscopic Index of Severity (CDEIS) Score Below 3) at Week 54 Using Local Non-blinded Assessments|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.|Week 54|Of the 89 patients in the Intent to Treat Population, 53 patients had data at Week 54, and are included in this summary. Percentage of patients is calculated by dividing the number of patients with a CDEIS score <3 at Week 54 by the total number of patients with CDEIS data at Week 54, multiplied by 100.||percentage of patients||95% Confidence Interval|Number
720401|NCT00297648|Secondary|Percentage of Patients With Endoscopic Complete Remission (Crohn’s Disease Endoscopic Index of Severity (CDEIS) Score Below 3) at Week 10 Using Central Blinded Assessments|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.|Week 10|Of the 89 patients in the Intent to Treat Population, 44 patients had a blinded assessment at Week 10 and Baseline, and are included in this summary. Percentage of patients is calculated by dividing the number of patients with a CDEIS score <3 at Week 10 by the total number of patients with CDEIS data at Week 10, multiplied by 100.||percentage of patients||95% Confidence Interval|Number
720402|NCT00297648|Secondary|Percentage of Patients With Endoscopic Complete Remission (Crohn’s Disease Endoscopic Index of Severity (CDEIS) Score Below 3) at Week 10 Using Local Non-blinded Assessments|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.|Week 10|Of the 89 patients in the Intent to Treat Population, 78 patients had data at Week 10, and are included in this summary. Percentage of patients is calculated by dividing the number of patients with a CDEIS score <3 at Week 10 by the total number of patients with CDEIS data at Week 10, multiplied by 100.||percentage of patients||95% Confidence Interval|Number
720403|NCT00297648|Secondary|Percentage of Patients With Endoscopic Remission (Crohn’s Disease Endoscopic Index of Severity (CDEIS) Score Below 6) at Week 54 Using Central Blinded Assessments|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.|Week 54|Of 89 patients in the Intent to Treat Population, 28 had matching nonblinded/blinded assessments and were in the subpopulation with a blinded assessment at Week 54 and Baseline. Percentage is calculated by dividing the number of patients with a CDEIS score <6 at Week 54 by the total number of patients with CDEIS data at Week 54, multiplied by 100.||percentage of patients||95% Confidence Interval|Number
720404|NCT00297648|Secondary|Percentage of Patients With Endoscopic Remission (Crohn’s Disease Endoscopic Index of Severity (CDEIS) Score Below 6) at Week 54 Using Local Non-blinded Assessments|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.|Week 54|Of the 89 patients in the Intent to Treat Population, 53 patients had data at Week 54, and are included in this summary. Percentage of patients is calculated by dividing the number of patients with a CDEIS score <6 at Week 54 by the total number of patients with CDEIS data at Week 54, multiplied by 100.||percentage of patients||95% Confidence Interval|Number
720601|NCT00312858|Primary|Participants With 1 or More Systemic Adverse Experience.|Systemic adverse experiences are unfavorable or unintended changes in the body after getting study vaccine. Collected the first 14 days after each of the 2 doses of hepatitis A vaccine (VAQTA™) (Days 1 to 14), given 6 months apart|6 months|Includes all participants who provided safety follow-up after receipt of any dose of VAQTA™ (hepatitis A vaccine)||Participants|||Number
720405|NCT00297648|Secondary|Percentage of Patients With Endoscopic Remission (Crohn’s Disease Endoscopic Index of Severity (CDEIS) Score Below 6) at Week 10 Using Central Blinded Assessments|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.|Week 10|Of the 89 patients in the Intent to Treat Population, 44 patients had a blinded assessment at Week 10 and Baseline, and are included in this summary. Percentage of patients is calculated by dividing the number of patients with a CDEIS score <6 at Week 10 by the total number of patients with CDEIS data at Week 10, multiplied by 100.||percentage of patients||95% Confidence Interval|Number
720406|NCT00297648|Primary|Mean Change From Baseline in CDEIS (Crohn’s Disease Endoscopic Index of Severity) Score at Week 10 Using Central Blinded Assessments|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation, thus a negative change from Baseline (i.e., Week 10 score minus Baseline score) indicates improvement.|Baseline, Week 10|Of the 89 patients in the Intent to Treat Population, 44 patients were in the subpopulation with a blinded assessment at Week 10 and Baseline, and are included in this summary. Change from Baseline has been calculated as the Week 10 score minus the Baseline score, thus a negative Change from Baseline indicates improvement.||Score on a scale||95% Confidence Interval|Mean
720407|NCT00297648|Secondary|Percentage of Patients With Endoscopic Remission (Crohn’s Disease Endoscopic Index of Severity (CDEIS) Score Below 6) at Week 10 Using Local Non-blinded Assessments|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.|Week 10|Of the 89 patients in the Intent to Treat Population, 78 patients had data at Week 10, and are included in this summary. Percentage of patients is calculated by dividing the number of patients with a CDEIS score <6 at Week 10 by the total number of patients with CDEIS data at Week 10, multiplied by 100.||percentage of patients||95% Confidence Interval|Number
720408|NCT00297648|Secondary|Percentage of Patients With Endoscopic Response (Crohn’s Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline of More Than 5 Points) at Week 54 Using Central Blinded Assessments|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.|Baseline, Week 54|Of 89 patients in the Intent to Treat Population 28 had matching nonblinded/blinded assessments and are in the subpopulation with blinded assessment at Week 54 and Baseline. Percentage is calculated by dividing the number patients with CDEIS decrease of at least 5 points at Week 54 by the number with CDEIS at Baseline and Week 54, multiplied by 100||percentage of patients||95% Confidence Interval|Number
720409|NCT00297648|Secondary|Percentage of Patients With Endoscopic Response (Crohn’s Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline of More Than 5 Points) at Week 54 Using Local Non-blinded Assessments|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.|Baseline, Week 54|Of the 89 patients in the Intent to Treat Population, 53 patients had data at Week 54 and at Baseline, and are included here. Percentage of patients is calculated by dividing the number of patients with a CDEIS decrease of at least 5 points at Week 54 by the number of patients with CDEIS data at both Baseline and Week 54, multiplied by 100.||percentage of patients||95% Confidence Interval|Number
720410|NCT00297648|Secondary|Percentage of Patients With Endoscopic Response (Crohn’s Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline of More Than 5 Points) at Week 10 Using Central Blinded Assessments|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.|Baseline, Week 10|Of the 89 patients in the Intent to Treat Population, 44 patients had a blinded assessment at Week 10 and at Baseline, and are included here. Percentage patients is calculated by dividing the number of patients with a CDEIS decrease of at least 5 points at Week 10 by the number of patients with CDEIS data at Baseline and Week 10, multiplied by 100.||percentage of patients||95% Confidence Interval|Number
720411|NCT00297648|Secondary|Percentage of Patients With Endoscopic Response (Crohn’s Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline of More Than 5 Points) at Week 10 Using Local Non-blinded Assessments|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.|Baseline, Week 10|Of the 89 patients in the Intent to Treat Population, 78 patients had data at Week 10 and at Baseline, and are included here. Percentage of patients is calculated by dividing the number of patients with a CDEIS decrease of at least 5 points at Week 10 by the number of patients with CDEIS data at both Baseline and Week 10, multiplied by 100.||percentage of patients||95% Confidence Interval|Number
720412|NCT00297648|Secondary|Percentage of Patients Achieving Mucosal Healing at Week 54 Using Central Blinded Assessments|Mucosal healing is defined as complete absence of ulceration contribution in the CDEIS (Crohn’s Disease Endoscopic Index of Severity) score|Week 54|Of the 89 patients in the Intent to Treat Population, 33 patients were in the subpopulation who had a blinded assessment at Week 54 and are included here. Percentage of patients is calculated by dividing the number of patients who achieved mucosal healing at Week 54 by the total number of patients with data collected, multiplied by 100.||percentage of patients||95% Confidence Interval|Number
720413|NCT00297648|Secondary|Percentage of Patients Achieving Mucosal Healing at Week 54 Using Local Non-blinded Assessments|Mucosal healing is defined as complete absence of ulceration contribution in the CDEIS (Crohn’s Disease Endoscopic Index of Severity) score|Week 54|Of the 89 patients in the Intent to Treat Population, 53 patients had data at Week 54, and are included in this summary. Percentage of patients is calculated by dividing the number of patients who achieved mucosal healing at Week 54 by the total number of patients with data collected, multiplied by 100.||percentage of patients||95% Confidence Interval|Number
720415|NCT00297648|Secondary|Percentage of Patients Achieving Mucosal Healing at Week 10 Using Local Non-blinded Assessments|Mucosal healing is defined as complete absence of ulceration contribution in the CDEIS (Crohn’s Disease Endoscopic Index of Severity) score|Week 10|Of the 89 patients in the Intent to Treat Population, 78 patients had data at Week 10, and are included in this summary. Percentage of patients is calculated by dividing the number of patients who achieved mucosal healing at Week 10 by the total number of patients with data collected, multiplied by 100.||percentage of patients||95% Confidence Interval|Number
720416|NCT00297648|Primary|Mean Change From Baseline in CDEIS (Crohn's Disease Endoscopic Index of Severity) Score at Week 10 Using Local Non-blinded Assessments|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation, thus a negative change from Baseline (i.e., Week 10 score minus Baseline score) indicates improvement.|Baseline, Week 10|Of the 89 patients in the Intent to Treat Population, 78 patients had data at both Baseline and Week 10, and are included in this summary. Change from Baseline has been calculated as the Week 10 score minus the Baseline score, thus a negative Change from Baseline indicates improvement.||score on a scale||95% Confidence Interval|Mean
720417|NCT00297778|Secondary|Abnormal Findings: Clinical Laboratory Evaluations (Biochemistry and Haematology)and Vital Signs||Baseline and Week 12|||participants|||Number
720418|NCT00297778|Secondary|Change From Baseline in the UPDRS Part IV Total Score at Week 12|The UPDRS Part IV measures motor complications (dyskinesia) and the total score could range from 0 to 23; where higher scores were indicative of worse symptoms.|Baseline and Week 12|FAS. 28 participants from those randomised and treated were excluded due to insufficient UPDRS data.||units on a scale||Standard Error|Least Squares Mean
720419|NCT00297778|Secondary|Change From Baseline in the UPDRS Part I Total Score at Week 12|The UPDRS part I total score measures depression on an ordinal scale ranging from 0 to 16. UPDRS Part I total scores could range from 0 to 16; where higher scores were indicative of worse symptoms.|Baseline and Week 12|FAS. 9 participants from those randomised and treated were excluded due to insufficient UPDRS data.||units on a scale||Inter-Quartile Range|Median
720420|NCT00297778|Secondary|Change From Baseline to End of Maintenance Phase in European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Pain Score at Week 12|The VAS is a method used for the measurement of pain. The patient is asked to place a mark on an uncalibrated (usually 0 – 10 cm) line representing the patient’s degree of general pain. The two extremities of the line were taken to represent ‘no pain’ and ‘unbearable pain’, respectively. VAS pain scores could range from 0 (no pain) to 100 (unbearable pain).|Baseline and Week 12|FAS. 15 participants from those randomised and treated were excluded due to insufficient EQ-5D data.||mm||Standard Error|Least Squares Mean
720421|NCT00297778|Secondary|Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Week 12|This is a 5-item patient reported measure of health status developed for use in evaluating health and healthcare. It produces a numeric score for health status on which full health has a value of 1 and death has a value of 0. Euro-QOL describes health status in terms of 5 dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The EQ-5D measures health status on a continuous scale ranging from 0 (dead) to 1 (full health)|Baseline and Week 12|FAS. 16 participants from those randomised and treated were excluded due to insufficient EQ-5D data.||units on a scale||Inter-Quartile Range|Median
720422|NCT00297778|Secondary|Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Week 12|The PDQ-39 measures aspects of health in PD participants, the overall index score is the mean of the eight individual domain scores measured on a continuous scale ranging from 0 (no problem at all) to 100 (maximum level of the problem)|Baseline and Week 12|FAS. 52 participants from those randomised and treated were excluded due to insufficient PDQ-39 data.||units on a scale||Inter-Quartile Range|Median
720423|NCT00297778|Secondary|Clinical Global Impressions of Global Improvement (CGI-I) at Week 12|The CGI-I measures the overall improvement in the participants condition from baseline on an ordinal scale ranging from 1 (very much improved) to 7 (very much worse)|Week 12|FAS. 9 participants from those randomised and treated were excluded due to insufficient CGI-I data.||units on a scale||Full Range|Median
720424|NCT00297778|Secondary|Change From Baseline in the UPDRS Part II+III Total Score at Week 12|The UPDRS part II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (normal) to 160 (worst symptoms)|Baseline and Week 12|FAS. 10 participants from those randomised and treated were excluded due to insufficient UPDRS data.||units on a scale||Standard Error|Least Squares Mean
720425|NCT00297778|Secondary|Change From Baseline in the UPDRS Part III Total Score at Week 12|The UPDRS part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (normal) to 108 (worst symptoms)|Baseline and Week 12|FAS. 10 participants from those randomised and treated were excluded due to insufficient UPDRS data.||units on a scale||Standard Error|Least Squares Mean
720426|NCT00297778|Secondary|Change From Baseline in the UPDRS Part II Total Score at Week 12|Unified Parkinson's Disease Rating Scale part II total score on FAS The UPDRS part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (normal) to 52 (worst symptoms)|Baseline and Week 12|FAS. 9 participants from those randomised and treated were excluded due to insufficient UPDRS data.||units on a scale||Standard Error|Least Squares Mean
720427|NCT00297778|Secondary|Change From Baseline in the Unified Parkinson's Disease Rating Scale (UPDRS) Part I Depression Score at Week 12|The UPDRS part I depression score measures depression on an ordinal scale ranging from 0 (none) to 4 (sustained depression/suicidal thoughts)|Baseline and Week 12|FAS. 9 participants from those randomised and treated were excluded due to insufficient UPDRS data.||units on a scale||Inter-Quartile Range|Median
720428|NCT00297778|Secondary|Change From Baseline in Snaith-Hamilton Pleasure Scale (SHAPS) Total Score at Week 12|The SHAPS measures anhedonia (inability to experience pleasure) on an ordinal scale ranging from 0 (no anhedonia) to 14 (worst anhedonia)|Baseline and Week 12|FAS. 9 participants from those randomised and treated were excluded due to insufficient SHAPS data.||units on a scale||Inter-Quartile Range|Median
720429|NCT00297778|Secondary|Change From Baseline in the Geriatric Depression Scale-Short Form (GDS-SF) (15-item Version) Total Score at Week 12|The GDS measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 15 (worst symptoms)|Baseline and Week 12|FAS. 9 participants from those randomised and treated were excluded due to insufficient GDS data.||units on a scale||Standard Error|Least Squares Mean
720430|NCT00297778|Secondary|Change in BDI-IA Clinical Response (at Least 50% Reduction in Symptoms) at Week 12|BDI clinical response was defined as a reduction of ≥50% from baseline|Week 12|FAS. 10 participants from those randomised and treated were excluded due to insufficient BDI data (1 due to a zero baseline score).||participants|||Number
720489|NCT00311311|Secondary|CIMT at Pre-conversion Baseline|Mean CIMT=average of left CIMT and right CIMT.|Pre-conversion baseline|On-Therapy Population; N=number of evaluable participants for the outcome measure at pre-conversion Baseline||mm||Standard Deviation|Mean
720431|NCT00297778|Primary|Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Week 12|The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)|Baseline and Week 12|The Full analysis set (FAS) made up of all randomised and treated participants with a baseline and at least one on-treatment assessment of the BDI. 9 participants from those randomised and treated were excluded due to insufficient BDI data.||Score on scale||Standard Error|Least Squares Mean
720432|NCT00297830|Secondary|Serum N-telopeplide Percent Change||24 months|Zero participants were analyzed because data was not collected. This was not a prespecified secondary outcome.|||||
720433|NCT00297830|Secondary|Percentage Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at 12 Months|BMD was measured by dual-energy x-ray absorptiometry (QDR-4500 densitometer; Hologic, Inc., Bedford, MA); short-term in vivo coefficient of variation is 0.68% (spine) and 1.36% (femoral neck). T scores were generated using gender-specific databases provided by the manufacturer.|Baseline, 12 months|||percent change||95% Confidence Interval|Mean
720434|NCT00297830|Secondary|Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 12 Months|BMD was measured by dual-energy x-ray absorptiometry (QDR-4500 densitometer; Hologic, Inc., Bedford, MA); short-term in vivo coefficient of variation is 0.68% (spine) and 1.36% (femoral neck). T scores were generated using gender-specific databases provided by the manufacturer.|Baseline, 12 months|||percent change||95% Confidence Interval|Mean
720435|NCT00297830|Primary|Percentage Change From Baseline in Total Hip Bone Mineral Density (BMD) at 12 Months|BMD was measured by dual-energy x-ray absorptiometry (QDR-4500 densitometer; Hologic, Inc., Bedford, MA); short-term in vivo coefficient of variation is 0.68% (spine) and 1.36% (femoral neck). T scores were generated using gender-specific databases provided by the manufacturer.|Baseline, 12 months|||percent change||95% Confidence Interval|Mean
720436|NCT00298090|Primary|Tissue Oxygen Saturation (StO2) Measurement on the Extremity With a Radial Arterial Line|Using near-infrared spectroscopy, the external device recorded raw StO2 values every 3.5 seconds for approximately 5 minutes prior to and immediately following the insertion of a radial arterial catheter on the ipsilateral side. The raw values were then compiled into one-minute averages.|up to 15 minutes|Data from 18 subjects not used due to only partial data captured resulting from logistical issues.||StO2 percent saturation||95% Confidence Interval|Mean
720437|NCT00298155|Secondary|To Determine the Effects of Different Modes of Androgen Deprivation on Serum DHT, T, Dehydroepiandrosterone (DHEA) and Androstenedione|Serum DHT|post-treatment|Full details of all androgens in the paper J Clinical Oncology VOLUME 32 NUMBER 3 JANUARY 20 2014||ng/dL||Standard Deviation|Mean
720438|NCT00298155|Primary|The Primary Endpoint of the Study is to Evaluate the Effect of Different Combinations of Anti-androgen Medicines on Androgen Levels in the Prostate Tissue|Tissue dihydrotesterone (DHT)|post-treatment|||ng/g||Standard Deviation|Mean
720439|NCT00306787|Secondary|Time to a Second Recurrence of Genital Herpes|"Patients who experienced a first recurrence of genital herpes and took study medication were followed for a period of up to 6 months to the second recurrence. Time to a second recurrence of genital herpes was calculated in 2 ways as follows:
From the date of treatment initiation no earlier than the recurrence of genital herpes to the date of onset for the second recurrence, or
From the date of healing of non-aborted lesions or confirmation of aborted lesions to the date of onset for the second recurrence."|Up to 6 months after investigator assessed healing of first recurrence of genital herpes|ITT population. Patients with missing time-to-second recurrence were not included in the calculation of the median.||days||Inter-Quartile Range|Median
720440|NCT00306787|Secondary|Number of Patients With a Second Recurrence of Genital Herpes|Patients who experienced a first recurrence of genital herpes and took study medication were followed for a period of up to 6 months to the second recurrence.|Up to 6 months after investigator assessed healing of first recurrence of genital herpes|ITT population included all randomized patients who initiated treatment with (i.e. received any dose of) the study drug, with the intention of treating genital herpes recurrences.||participants|||Number
720441|NCT00306787|Secondary|Time to Resolution of Symptoms Associated With Recurrent Genital Herpes|Kaplan-Meier estimated time in hours of the resolution of all symptoms (pain, burning, itching, tingling and tenderness) associated with recurrent genital herpes. Kaplan-Meier method is used to estimate the time to resolution of symptoms.|72 hours after initiation of study medication up to Day 20|ITT population. If the resolution of any or all symptoms was not confirmed by a subsequent visit or diary entry, the time to resolution was censored at the time of the last diary entry. If a patient dropped out before any diary entries were created, the patient was assigned a censoring time of 0. n= number of patients with symptoms.||hours||Inter-Quartile Range|Median
720442|NCT00306787|Secondary|Investigator-assessed Time to Healing of All (Non-aborted and Aborted) Genital Herpes Lesions|Lesions that developed no further than the papule stage (erythema may have been present) were considered as aborted lesions. Prodrome also was considered the sign of aborted lesions in this study. Lesions which underwent vesicle, ulcer/soft crust, and/or hard crust formation and required re-epithelialization for healing were considered as non-aborted lesions. The median time was estimated using Kaplan-Meier method.|72 hours after initiation of study medication up to Day 20|ITT population. Median time was estimated by kaplan-Meier method by censoring the missing non-aborted times at last clinical observation. Patients with aborted lesions were assigned a time to healing of zero.||days||Inter-Quartile Range|Median
720443|NCT00306787|Secondary|Percentage of Participants With Aborted Genital Herpes Lesions|Lesions that developed no further than the papule stage (erythema may have been present) were considered as aborted lesions. Prodrome also was considered the sign of aborted lesions in this study. Lesions which underwent vesicle, ulcer/soft crust, and/or hard crust formation and required re-epithelialization for healing were considered as non-aborted lesions.|72 hours after initiation of study medication up to Day 20|ITT population. Patients who discontinued from the study before healing of non-aborted lesions was confirmed and patients who completed the study after 21 days since treatment initiation without non-aborted lesion stages and without a final assessment on aborted lesion status were assumed to have non-aborted lesions in this analysis.||Percentage of participants|||Number
720553|NCT00312338|Primary|Susceptability Changes in Haemophilus Influenzae Distal to the Site of Instillation|"Susceptibility change refers to a change in vulnerability of a specified bacterial strain to antibiotic treatment. Susceptibility was assessed by broth microdilution methods recommended by the Clinical and Laboratory Standards Institute (CLSI).
0% = zero isolates were resistant to antibiotic 100% = all isolates were resistant to antibiotic"|Day 0, Day 42|||Percent of resistant isolates|||Number
720444|NCT00306787|Primary|Investigator-assessed Time to Healing of All Non-aborted Genital Herpes Lesions|Time to healing of all non-aborted genital herpes lesions was defined as the time from the first dose of study drug taken no earlier than the recurrence of genital herpes to the investigator-assessed time of healing (i.e. loss of all crusts and re-epithelialization of the lesions; erythema could have been present). Non-aborted lesions are lesions which underwent vesicle, ulcer/soft crust, and/or hard crust formation and required re-epithelialization for healing. The median time was estimated using Kaplan-Meier method by censoring missing values at the time of last clinical lesion observation.|72 hours after initiation of study medication up to Day 20|Modified Intent To Treat (mITT) population. The mITT population included all patients who initiated treatment with the study drug, with the intention of treating genital herpes recurrences who developed non-aborted genital herpes lesions during the treated recurrence except those with confirmed aborted lesions at the final clinical assessment.||days||Inter-Quartile Range|Median
720445|NCT00306852|Secondary|Failure Rate|Failure was prospectively defined as IOP greater than 21 mm Hg or less than 20 percent reduction below baseline on 2 consecutive follow-up visits after 3 months, IOP less than or equal to 5 mm Hg on 2 consecutive follow-up visits after 3 months, re-operation for glaucoma, or loss of light perception vision.|5 years|||percentage of participants|||Number
720446|NCT00306852|Secondary|Need for Supplemental Medical Therapy|The number of supplemental glaucoma medications required in the Implant Group and Trabeculectomy Group at 5 years|5 years|||number of medications||Standard Deviation|Mean
720447|NCT00306852|Secondary|Reoperations for Glaucoma|Reoperations for glaucoma was defined as additional glaucoma surgery requiring a return to the operating room.|5 years|||participants|||Number
720448|NCT00306852|Secondary|Visual Acuity|Visual acuity was measured by the total number of letters read (correctly) using a ETDRS eye chart|5 years|Participants who complete 5 years of follow-up||Letters||Standard Deviation|Mean
720449|NCT00306852|Primary|Rate of Complications|Complications associated with both surgical procedures|5 years|||participants|||Number
720450|NCT00306852|Primary|Change in Intraocular Pressure|The data value from the Baseline visit and 5 year follow-up visit were combined. Specifically, values were calculated by subtracting the 5 Year Intraocular Pressure from the Baseline Intraocular Pressure.|Baseline to 5 years|Participants who completed 5 years of follow-up||mm Hg||Standard Deviation|Mean
720451|NCT00306891|Secondary|Part B: Progression-free Survival (PFS)|"Target lesions: Progressive Disease (PD) At least a 20% increase in the sum of LD (longest diameter)of target lesions taking as references the smallest sum LD recorded (either at baseline or at previous assessment since treatment began).
Non target lesions: Persistence of one or more non-target lesion or/and maintenance of tumour marker level above the normal limits.
Progression (PD) Unequivocal progression of existing non-target lesions."|Number of days from randomisation until progressive disease based on RECIST (progression of target lesions, clear progression of existing non-target lesions or the appearance of one or more new lesions) or death in the absence of progression.|ITT (intention-to-treat ) patients with baseline RECIST data.One patient was randomized and had baseline RECIST assessments, but did not have any further RECIST assessments. Therefore they were censored at baseline, meaning the lowest value in the range was set to zero.||Days||Full Range|Median
720452|NCT00306891|Secondary|Part B: Best Overall Response Rate (ORR)|"Evaluation of target lesions Complete Response(CR)Disappearance of all target lesions Partial Response(PR) At least a 30% decrease in the sum of LD(longest diameter)of target lesions taking as reference the baseline sum LD.Progressive Disease(PD).At least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded(either at baseline or at previous assessment since treatment began).Stable Disease(SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.Note: Appearance of new lesions only counts towards the overall visit response,not towards the response of target or non-target lesions.
Evaluation of non-target lesions Complete Response(CR)Disappearance of all non-target lesions Non-Complete Response(non-CR/Non-Progression[non-PD])Persistence of one or more non-target lesion or/and maintenance of tumour marker level above the normal limits.Progression(PD)Unequivocal progression of existing non-target lesions"|Baseline, week 8, week 16 and every 8 weeks thereafter until discontinuation.|ITT (intention-to-treat ) patients with baseline RECIST data||Participants|||Number
720453|NCT00306891|Secondary|Part A: Apparent Total Body Clearance (CL/F)|Apparent total body clearance of drug from plasma|Measurements were collected up to 168 hours (following single dosing).|||L/h||Full Range|Geometric Mean
720454|NCT00306891|Secondary|Part A: Terminal Phase Half-life (t1/2λz)|Terminal phase half-life|Measurements were collected up to 168 hours (following single dosing).|||hr||Full Range|Geometric Mean
720455|NCT00306891|Secondary|Part A: Time to Peak or Maximum Concentration (Tmax)|Time to reach peak or maximum concentration or maximum response|Measurements were collected up to 168 hours (following single dosing).|||hr||Full Range|Geometric Mean
720456|NCT00306891|Secondary|Part A: AUC (0-t)|Area under the curve from time 0 to the last measureable time point|Measurements were collected up to 168 hours (following single dosing).|||ng*h/mL||Full Range|Geometric Mean
720457|NCT00306891|Primary|Part A: Maximum Plasma (Peak) Concentration (Cmax)|Maximum plasma drug concentration|Measurements were collected up to 168 hours (following single dosing).|||ng/mL||Full Range|Geometric Mean
720458|NCT00306891|Primary|Part A: Area Under Plasma Concentration-time Curve (AUC)|Area under plasma concentration-time curve from zero to infinity|Measurements were collected up to 168 hours (following single dosing).|||ng*h/mL||Full Range|Geometric Mean
720459|NCT00306917|Primary|Harris Hip Score (HHS)|The Harris Hip scoring system assigns a numeric value to responses from patients and assessments made by a surgeon. A score of 90-100 is excellent, 80-90 is good, 70-80 is fair, 60-69 is poor, and 60 or below is failed. The patient records the following: pain level, need for assistance when walking, presence of a limp, distance able to walk, ability to put on shoes and socks, climb stairs, use public transportation and the length of time one is able to comforatably sit in a chair are all scored. The doctor assesses patient hip function by testing flexion, extension, adduction and abduction.|Preoperative, 6, 12, 24, 36, 48, and 60 months|Before the first interval there were five missing HHS scores for the DuoFix arm and four missing HHS scores for the Porocoat Porous Coated arm. At the final interval (60 months), there were eleven subjects in the DuoFix arm with complete HHS scores and there were fourteen subjects in the Porocoat Porous Coated arm with complete HHS scores.||Units on a scale||Standard Deviation|Mean
720460|NCT00306917|Secondary|Medical Imaging||postoperative, 6, 12, 24, 36, 48 and 60 months||||||
720461|NCT00311155|Secondary|Mean Change in Systolic Blood Pressure Overall and for Each Treatment From Baseline to the Completion of the Treatment||Baseline to ≤20 weeks|691 = the full analysis set (FAS). FAS consists of all participants who received trial medication and who had data from at least one post-baseline visit with regard to the primary efficacy parameter, i.e., both the systolic and the diastolic blood pressure (BP) had to be measured. N is reduced for each treatment as subjects attain BP goals.||mm Hg||Standard Deviation|Mean
720462|NCT00311155|Secondary|Mean Change in Diastolic Blood Pressure Overall and for Each Treatment From Baseline to the Completion of the Treatment||Baseline to ≤20 weeks|691 = the full analysis set (FAS). FAS consists of all participants who received trial medication and who had data from at least one post-baseline visit with regard to the primary efficacy parameter, i.e., both the systolic and the diastolic blood pressure (BP) had to be measured. N is reduced for each treatment as subjects attain BP goals.||mm Hg||Standard Deviation|Mean
720463|NCT00311155|Secondary|Percentage of Participants Who Were Systolic Responders Overall and for Each Treatment From Baseline to the Completion of the Treatment During Which Blood Pressure Goals Were Achieved|Systolic responders defined as a participant who is a normaliser or has a lowering of the mean sitting systolic blood pressure of ≥20 mmHg at trough|Baseline to ≤20 weeks|691 = the full analysis set (FAS). FAS consists of all participants who received trial medication and who had data from at least one post-baseline visit with regard to the primary efficacy parameter, i.e., both the systolic and the diastolic blood pressure (BP) had to be measured. N is reduced for each treatment as subjects attain BP goals.||Percentage of Participants|||Number
720464|NCT00311155|Secondary|Percentage of Participants Who Were Diastolic Responders Overall and for Each Treatment From Baseline to the Completion of Treatment During Which Blood Pressure Goals Were Achieved.|Diastolic responders were defined as a participant who is a normaliser or has a lowering of the mean sitting diastolic blood pressure of ≥10 mmHg at trough.|Baseline to ≤20 weeks|691 = the full analysis set (FAS). FAS consists of all participants who received trial medication and who had data from at least one post-baseline visit with regard to the primary efficacy parameter, i.e., both the systolic and the diastolic blood pressure (BP) had to be measured. N is reduced for each treatment as subjects attain BP goals.||Percentage of participants|||Number
720465|NCT00311155|Secondary|Percentage of Participants Who Achieved Normalized Blood Pressure Overall and for Each Treatment From Baseline to Completion of the Treatment During Which Blood Pressure Goals Were Achieved|Normalized blood pressure is defined as a mean sitting systolic blood (sBP) pressure at trough of <140 mmHg and mean sitting diastolic blood pressure (dBP)of <90 mmHg for non-diabetic patients or a mean sitting sBP at trough of <130 mmHg and mean sitting dBP <80 mmHg for diabetic patients.|Baseline to ≤20 weeks|691 = the full analysis set (FAS). FAS consists of all participants who received trial medication and who had data from at least one post-baseline visit with regard to the primary efficacy parameter, i.e., both the systolic and the diastolic blood pressure (BP) had to be measured. N is reduced for each treatment as subjects attain BP goals.||Percentage of participants|||Number
720466|NCT00311155|Primary|The Percentage of Participants Treated to Target Blood Pressure Goals Overall and for Each Treatment Step From Baseline to Completion of Treatment During Which the Goal Was Achieved.|For non-diabetic participants the target seated blood pressure goals were: Systolic - ≤130 mm Hg; Diastolic - ≤85 mm Hg. For diabetic participants the target seated blood pressure goals were: Systolic - <130 mm Hg; Diastolic - <80 mm Hg.|Baseline to ≤20 weeks|691 = the full analysis set (FAS). FAS consists of all participants who received trial medication and who had data from at least one post-baseline visit with regard to the primary efficacy parameter, i.e., both the systolic and the diastolic blood pressure (BP) had to be measured. N is reduced for each treatment as subjects attain BP goals.||Percentage of participants|||Number
720467|NCT00311181|Primary|DFT (4.5 ms Waveform)||Implant|||Volts||Standard Error|Mean
720468|NCT00311181|Primary|DFT (2.5 ms Waveform)||Implant|||Volts||Standard Error|Mean
720469|NCT00311181|Primary|Defibrillation Thresholds (DFTs) (3.5 ms Waveform)||Implant|||Volts||Standard Error|Mean
720470|NCT00311311|Secondary|Annual Rate of Change in TPV From Pre-conversion Baseline to 18, 24 and 36 Months Post Transplant|Within-subject annual change rate in TPV in the left and right distal common carotid arteries from the pre-conversion baseline to 18, 24 and 36 months post kidney transplant as determined by ultrasound. Annual change rate equals (=) (TPV at month 18, 24 and 36 post-transplant minus [-] TPV at pre-conversion baseline) divided (/) by imaging interval in years. TPV is the sum of assessment in left and right distal common carotid arteries.|Pre-conversion baseline, and 18, 24 and 36 months post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time point||mmˆ3/year||Standard Deviation|Mean
720471|NCT00311311|Secondary|Number of Participants Who Used Anti-hypertensive Medications|"Participants who reported yes for taking anti-hypertensive medications as concomitant medication."|From consent to conversion, from conversion to Month 12, from Months 12 to 24, and from Months 24 to 36 post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable at the specific time point||participants|||Number
720472|NCT00311311|Secondary|Number of Participants Who Used Lipid Lowering Therapies|"Participants who reported yes for taking lipid lowering therapies as concomitant medication."|From consent to conversion, from conversion to Month 12, from Months 12 to 24, and from Months 24 to 36 post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable at the specific time point||participants|||Number
720473|NCT00311311|Secondary|Change From Pre-conversion Baseline in Folate at 12, 24 and 36 Months Post-transplant|Folate is a biomarker for cardiovascular disease and atherosclerosis risk. A lower level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values.|Pre-conversion baseline, 12, 24 and 36 months post-transplant|Two types of folate tests were used: serum folate and red blood cell (RBC) folate. The tests were not consistent across sites. Therefore, the evaluation was not analyzed.|||||
720474|NCT00311311|Secondary|Change From Pre-conversion Baseline in Uric Acid at Months 12, 24 and 36 Post-transplant|Uric Acid is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values.|Pre-conversion baseline, 12, 24 and 36 months post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time points||µmol/L||Standard Deviation|Mean
721026|NCT00317941|Secondary|Percentage of Participants Without Pain Reported by Participants||Up to 3 months assessed 24 hours after each injection|||Percentage of participants|||Number
720475|NCT00311311|Secondary|Change From Pre-conversion Baseline in Vitamin B12 at Months 12, 24 and 36 Post-transplant|Vitamin B12 is a biomarker for cardiovascular disease and atherosclerosis risk. A lower level indicates a greater risk. Change = month x post-transplant values - pre-conversion values.|Pre-conversion baseline, 12, 24 and 36 months post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time points||pmol/L||Standard Deviation|Mean
720476|NCT00311311|Secondary|Change From Pre-conversion Baseline in Fibrinogen at Months 12, 24 and 36 Post-transplant|Fibrinogen is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values.|Pre-conversion baseline, 12, 24 and 36 months post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time point||gram per liter (g/L)||Standard Deviation|Mean
720477|NCT00311311|Secondary|Change From Pre-conversion Baseline in Lipoprotein(a) at Months 12, 24 and 36 Post-transplant|Lipoprotein(a) is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values.|Pre-conversion baseline, 12, 24 and 36 months post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time point||milligram per deciliter (mg/dL)||Standard Deviation|Mean
720478|NCT00311311|Secondary|Change From Pre-conversion Baseline in Homocysteine at Months 12, 24 and 36 Post-transplant|Homocysteine is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values.|Pre-conversion baseline, 12, 24 and 36 months post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable at the specific time point||micromole/liter (µmol/L)||Standard Deviation|Mean
720479|NCT00311311|Secondary|Change From Pre-conversion Baseline in Interleukin-6 (IL-6) at Months 12, 24 and 36 Post-transplant|IL-6 is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion values.|Pre-conversion baseline, 12, 24 and 36 months post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable at the specific time point||pg/mL||Standard Deviation|Mean
720480|NCT00311311|Secondary|Change From Pre-conversion Baseline in Endothelin-1 at Months 12, 24 and 36 Post-transplant|Endothelin-1 is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates greater risk. Change = month x post-transplant values - pre-conversion baseline values.|Pre-conversion baseline, 12, 24 and 36 months post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable at the specific time point||pg/mL||Standard Deviation|Mean
720481|NCT00311311|Secondary|Change From Pre-conversion Baseline in Tumor Necrosis Factor Alpha (TNF-alpha) at Months 12, 24 and 36 Post-transplant|TNF-alpha is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values.|Pre-conversion baseline, 12, 24 and 36 months post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time point||pg/mL||Standard Deviation|Mean
720482|NCT00311311|Secondary|Change From Pre-conversion Baseline in High Sensitivity C-Reactive Protein (hsCRP) at Months 12, 24 and 36 Post-transplant.|hsCRP is a biomarker of cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values.|Pre-conversion baseline, 12, 24 and 36 months post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time point||mg/L||Standard Deviation|Mean
720483|NCT00311311|Secondary|Change From Pre-conversion Baseline in Adiponectin at Months 12, 24 and 36 Post-transplant|Adiponectin is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates less risk. Change = month x post-transplant values - pre-conversion baseline values.|Pre-conversion baseline, 12, 24 and 36 months post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time point||microgram per milliliter (µg/mL)||Standard Deviation|Mean
720484|NCT00311311|Secondary|Change From Pre-conversion Baseline in Glycosylated Hemoglobin(HbA1C) at Months 12, 24, and 36 Post-transplant|HbA1C, change = value at month x post-transplant - pre-conversion baseline.|Pre-conversion baseline, 12, 24 and 36 months post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at the specific time point||percentage of glucose||Standard Deviation|Mean
720485|NCT00311311|Secondary|Change From Pre-conversion Baseline in Insulin at Months 12, 24, and 36 Post-transplant|Fasting insulin. Change = value at month x post-transplant - pre-conversion baseline.|Pre-conversion baseline, 12, 24 and 36 months post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time point||picomole/liter (pmol/L)||Standard Deviation|Mean
720486|NCT00311311|Secondary|Change From Pre-conversion Baseline in Glucose at Months 12, 24 and 36 Post-transplant|Fasting plasma glucose. Change = value at month x post-transplant - pre-conversion baseline values.|Pre-conversion baseline, 12, 24 and 36 months post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time point||mmol/L||Standard Deviation|Mean
720487|NCT00311311|Secondary|Change From Pre-conversion Baseline in Fasting Lipid Parameters at 12, 18, 24 and 36 Months Post-transplant|Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL) and Triglyceride (Tg) blood concentrations. Higher levels of TC, LDL and Tg are less desirable. Lower levels of HDL are less desirable. Change for each parameter = value at 12, 18, 24 and 36 months post-transplant - value at pre-conversion baseline.|Pre-conversion baseline, and 12, 18, 24 and 36 months post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time point||millimole/liter (mmol/L)||Standard Deviation|Mean
720488|NCT00311311|Secondary|Change From Pre-conversion Baseline in Carotid Plaque Roughness at 12 and 24 Months Post-transplant|Carotid plaque roughness as determined by ultrasound. Change equals (=) value at post-transplant month x minus (-) pre-conversion baseline.|Pre-conversion baseline, 12, and 24 months post-transplant|Evaluation of carotid plaque roughness at pre-conversion baseline, and at 12 and 24 months post-transplant was planned in the study design, however during the study conduct, it was removed as a cardiovascular endpoint since it was not validated.|||||
720490|NCT00311311|Secondary|Annual Change Rate in Carotid Intima Media Thickness (CIMT) From Pre-conversion Baseline at 12, 18, 24 and 36 Months Post-transplant|Within-subject annual change rate in CIMT as determined by ultrasound. Mean CIMT=average of left CIMT and right CIMT. Annual CIMT Change Rate (mm/year) = (CIMT at Month x Post-transplant Visit – CIMT at Conversion Baseline) / Imaging interval in years.|Pre-conversion baseline, and 12, 18, 24 and 36 months post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time point||millimeter/year (mm/year)||Standard Deviation|Mean
720491|NCT00311311|Primary|TPV at Pre-conversion Baseline|TPV is the sum of the assessment in left and right distal common carotid arteries.|Pre-conversion baseline|On-Therapy Population; N=number of evaluable participants for the outcome measure at pre-conversion Baseline||mmˆ3||Standard Deviation|Mean
720492|NCT00311311|Primary|Annual Change Rate in Total Plaque Volume (TPV) From Pre-conversion Baseline to 12 Months Post-transplant|Within-subject annual change rate in TPV in the left and right distal common carotid arteries from the pre-conversion baseline to 12 months post kidney transplant as determined by ultrasound. Annual change rate equals (=) (TPV at month 12 post-transplant minus [-] TPV at pre-conversion baseline) divided (/) by imaging interval in years. TPV is the sum of assessment in left and right distal common carotid arteries.|Pre-conversion baseline and 12 months post-transplant|On-Therapy Population: includes all intent-to-treat (ITT) subjects who also remained on assigned therapy until 12 months post-transplant for the primary endpoint, or until 36 months post-transplant for the cardiovascular and safety endpoints; N=number of evaluable participants for the outcome measure at 12 months post-transplant||millimeter cube/year (mmˆ3/year)||Standard Deviation|Mean
720493|NCT00311363|Secondary|Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Hours Awake Per Night Due to RLS Symptoms in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF|The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep. Participants rated overall sleep quality and their ability to function on scales ranging from “excellent” to “poor” and were asked to provide the number of nights they experienced RLS symptoms and the number of times/hours they awoke at night during the week prior to the measurement.|Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase|Single-blind Intent-to-Treat (SB ITT) Population: all participants who enrolled into the study, received at least one dose (or any portion of dose) of SB study drug, and for whom at least one SB visit (Weeks 0-24) IRLS total score and investigator-rated CGI-I was available.||participants|||Number
720494|NCT00311363|Secondary|Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Awakenings During the Night Due to RLS Symptoms in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF|The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep. Participants rated overall sleep quality and their ability to function on scales ranging from “excellent” to “poor” and were asked to provide the number of nights they experienced RLS symptoms and the number of times/hours they awoke at night during the week prior to the measurement.|Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase|Single-blind Intent-to-Treat (SB ITT) Population: all participants who enrolled into the study, received at least one dose (or any portion of dose) of SB study drug, and for whom at least one SB visit (Weeks 0-24) IRLS total score and investigator-rated CGI-I was available.||participants|||Number
720495|NCT00311363|Secondary|Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Nights With RLS Symptoms in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF|The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep. Participants rated overall sleep quality and their ability to function on scales ranging from “excellent” to “poor” and were asked to provide the number of nights they experienced RLS symptoms and the number of times/hours they awoke at night during the week prior to the measurement.|Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase|Single-blind Intent-to-Treat (SB ITT) Population: all participants who enrolled into the study, received at least one dose (or any portion of dose) of SB study drug, and for whom at least one SB visit (Weeks 0-24) IRLS total score and investigator-rated CGI-I was available.||participants|||Number
720496|NCT00311363|Secondary|Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Ability to Function in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF|The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep. Participants rated overall sleep quality and their ability to function on scales ranging from “excellent” to “poor” and were asked to provide the number of nights they experienced RLS symptoms and the number of times/hours they awoke at night during the week prior to the measurement.|Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase|Single-blind Intent-to-Treat (SB ITT) Population: all participants who enrolled into the study, received at least one dose (or any portion of dose) of SB study drug, and for whom at least one SB visit (Weeks 0-24) IRLS total score and investigator-rated CGI-I was available.||participants|||Number
720497|NCT00311363|Secondary|Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Overall Quality of Sleep in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF|The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep. Participants rated overall sleep quality and their ability to function on scales ranging from “excellent” to “poor” and were asked to provide the number of nights they experienced RLS symptoms and the number of times/hours they awoke at night during the week prior to the measurement.|Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase|Single-blind Intent-to-Treat (SB ITT) Population: all participants who enrolled into the study, received at least one dose (or any portion of dose) of SB study drug, and for whom at least one SB visit (Weeks 0-24) IRLS total score and investigator-rated CGI-I was available.||participants|||Number
720527|NCT00311376|Secondary|Change From Baseline in Maximum Detrusor Pressure (MDP)|Change from baseline in MDP during first involuntary detrusor contraction at week 6. MDP represents the maximum pressure (peak amplitude) in the bladder during the first involuntary contraction of the bladder muscle. The greater the negative number change from baseline, the better the improvement.|Baseline, Week 6|Intent-to-Treat defined as all patients who started the study (randomized)||Centimeters of water (cm H20)||Standard Deviation|Mean
720498|NCT00311363|Secondary|Mean Change From Baseline in the Overall Quality of Life Impact Score of the RLS Quality of Life (QoL) Questionnaire at Week 24 (SB Treatment Phase)|The RLS QoL is an 18-item scale assessing the impact of RLS on daily life, emotional well-being, social and work life. Responses range from 1 (not at all/never) to 5 (a lot/all of the time). Ten items contribute to a single summary score, the Overall Life Impact, which is standardized to range from 0-100, with lower scores representing better QoL.|Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase|Single-blind Intent-to-Treat (SB ITT) Population: all participants who enrolled into the study, received at least one dose (or any portion of dose) of SB study drug, and for whom at least one SB visit (Weeks 0-24) IRLS total score and investigator-rated CGI-I was available. Some participants did not satisfy this description, and 13 had missing data||points on a scale||Standard Deviation|Mean
720499|NCT00311363|Secondary|Mean Change From Baseline in the MOS Sleep Scale Domain, Sleep Quantity, Score at Week 24 (SB Treatment Period) Using LOCF|The MOS Sleep Scale is a participant-rated non-disease-specific measure with questions relating to four areas related to sleep: quantity (number of hours slept), sleep disturbance, sleep adequacy, and somnolence. The Sleep Quantity Domain score is a participant-rated estimate of the average number of hours of sleep per night over the month.|Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase|Single-blind Intent-to-Treat (SB ITT) Population: all participants who enrolled into the study, received at least one dose (or any portion of dose) of SB study drug, and for whom at least one SB visit (Weeks 0-24) IRLS total score and investigator-rated CGI-I was available. Some participants did not satisfy this description, and 12 had missing data||hours||Standard Deviation|Mean
720500|NCT00311363|Secondary|Mean Change From Baseline to Week 24 (SB Treatment Period) in the Mean Sleep Adequacy Domain Score of the MOS Sleep Scale Using LOCF|The MOS Sleep Scale is a participant-rated non-disease-specific measure with questions relating to four areas related to sleep: quantity (number of hours slept), sleep disturbance, sleep adequacy, and daytime somnolence. The MOS Sleep Scale sleep adequacy domain is a participant-rated measure of the adequacy of sleep over the month prior to measurement. Questions are scored, and responses are converted to a 0 to 100 scale, with higher scores representing more adequate ratings of sleep.|Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase|Single-blind Intent-to-Treat (SB ITT) Population: all participants who enrolled into the study, received at least one dose (or any portion of dose) of SB study drug, and for whom at least one SB visit (Weeks 0-24) IRLS total score and investigator-rated CGI-I was available. Some participants did not satisfy this description and 12 had missing data.||points on a scale||Standard Deviation|Mean
720501|NCT00311363|Secondary|Mean Change From Baseline to Week 24 (SB Treatment Period) in the Mean Sleep Disturbance Domain Score of the MOS Sleep Scale Using LOCF|The MOS Sleep Scale is a participant-rated non-disease-specific measure with questions relating to four areas related to sleep: quantity (number of hours slept), sleep disturbance, sleep adequacy, and daytime somnolence. . The MOS Sleep Scale sleep disturbance domain is a participant-rated measure of sleep disturbance over the month prior to the measurement. Questions are scored, and responses are converted to a 0 to 100 scale, with lower scores representing less sleep disturbance.|Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase|Single-blind Intent-to-Treat (SB ITT) Population: all participants who enrolled into the study, received at least one dose (or any portion of dose) of SB study drug, and for whom at least one SB visit (Weeks 0-24) IRLS total score and investigator-rated CGI-I was available. Some participants did not satisfy this description and 12 had missing data.||points on a scale||Standard Deviation|Mean
720502|NCT00311363|Secondary|Mean Change From Baseline to Week 24 (SB Treatment Period) in the Mean Daytime Somnolence Domain Score of the Medical Outcomes Study (MOS) Sleep Scale Using LOCF|The MOS Sleep Scale is a participant-rated non-disease-specific measure with questions relating to four areas related to sleep: quantity (hours slept), sleep disturbance, sleep adequacy, and daytime somnolence. Responses are recoded so that a higher score reflects more of the attribute, and then converted to a 0 to 100 scale. The daytime somnolence score is based on questions pertaining to feeling drowsy or sleepy, trouble staying awake, and taking naps > 5 minutes. For daytime somnolence, a negative value indicates an improvement.|Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase|Single-blind Intent-to-Treat (SB ITT) Population: all participants who enrolled into the study, received at least one dose (or any portion of dose) of SB study drug, and for whom at least one SB visit (Weeks 0-24) IRLS total score and investigator-rated CGI-I was available. Some participants did not satisfy this description and 12 had missing data.||points on a scale||Standard Deviation|Mean
720503|NCT00311363|Secondary|Number of Participants in Each Category of the Participant-Rated CGI-I at Week 24/End of Treatment (SB Treatment Phase) Using LOCF|The participant-rated CGI-I scale is a self-rated assessment designed to allow participants to rate the change of their disease severity over time based on a seven-point rating scale, with a score of 1 being “very much improved” and a score of 7 being “very much worse” compared to baseline.|Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase|Single-blind Intent-to-Treat (SB ITT) Population: all participants who enrolled into the study, received at least one dose (or any portion of dose) of SB study drug, and for whom at least one SB visit (Weeks 0-24) IRLS total score and investigator-rated CGI-I was available. Some participants did not satisfy this description and 3 had missing data.||participants|||Number
720504|NCT00311363|Secondary|Number of Participants in Each Category of the Investigator-Rated CGI-I at Week 24/End of Treatment (SB Treatment Phase) Using LOCF|The CGI-I scale is a widely used tool designed to allow clinicians to rate the severity of illness and the change over time based on a seven-point rating scale, with a score of 1 being “very much improved” and a score of 7 being “very much worse” compared to baseline.|Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase|Single-blind Intent-to-Treat (SB ITT) Population: all participants who enrolled into the study, received at least one dose (or any portion of dose) of SB study drug, and for whom at least one SB visit (Weeks 0 through 24) IRLS total score and investigator-rated CGI-I was available. Some participants did not satisfy this description.||participants|||Number
720528|NCT00311376|Secondary|Change From Baseline in Maximum Cystometric Capacity (MCC)|Change from baseline in MCC at week 6. MCC represents the maximum volume of urine the bladder holds. A positive number change from baseline represents an improvement (increase) in maximum volume of urine the bladder holds.|Baseline, Week 6|Intent-to-Treat defined as all patients who started the study (randomized)||Millimeters (mL) of urine||Standard Deviation|Mean
720505|NCT00311363|Secondary|Mean Change From Baseline in the IRLS Scale Total Score at Week 24 (SB Treatment Phase) Using LOCF|The IRLS Rating scale is a measure of disease severity. The scale reflects participant-reported assessment of sensory and motor features and associated sleep problems in RLS. In addition, items are included that assess the impact of symptoms on participants’ mood, daily life, and activities. Total score ranges from 0-40 points, with 40 being the most severe.|Days 1 to 168 (Baseline to Week 24 of SB Phase)|Single-blind Intent-to-Treat (SB ITT) Population: all participants who enrolled into the study, received at least one dose (or any portion of dose) of SB study drug, and for whom at least one SB visit (Weeks 0 through 24) IRLS total score and investigator-rated CGI-I was available. Some participants did not satisfy this description.||points on a scale||Standard Deviation|Mean
720506|NCT00311363|Secondary|Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Hours Awake Per Night Due to RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF|The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep. Participants rated overall sleep quality and their ability to function on scales ranging from “excellent” to “poor” and were asked to provide the number of nights they experienced RLS symptoms and the number of times/hours they awoke at night during the week prior to the measurement.|Randomization (Week 24) and Week 36 (or end of DB treatment)|Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.||participants|||Number
720507|NCT00311363|Secondary|Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Awakenings During Night Due to RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF|The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep. Participants rated overall sleep quality and their ability to function on scales ranging from “excellent” to “poor” and were asked to provide the number of nights they experienced RLS symptoms and the number of times/hours they awoke at night during the week prior to the measurement.|Randomization (Week 24) and Week 36 (or end of DB treatment)|Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.||participants|||Number
720508|NCT00311363|Secondary|Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Nights With RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF|The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep. Participants rated overall sleep quality and their ability to function on scales ranging from “excellent” to “poor” and were asked to provide the number of nights they experienced RLS symptoms and the number of times/hours they awoke at night during the week prior to the measurement.|Randomization (Week 24) and Week 36 (or end of DB treatment)|Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.||participants|||Number
720509|NCT00311363|Secondary|Number of Participants With the Indicated Post-Sleep Questionnaire (PSQ) Responses to the Question Regarding Their Ability to Function in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF|The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep. Participants rated overall sleep quality and their ability to function on scales ranging from “excellent” to “poor” and were asked to provide the number of nights they experienced RLS symptoms and the number of times/hours they awoke at night during the week prior to the measurement.|Randomization (Week 24) and Week 36 (or end of DB treatment)|Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.||participants|||Number
720510|NCT00311363|Secondary|Number of Participants With the Indicated Post-Sleep Questionnaire (PSQ) Responses to the Question Regarding Their Overall Quality of Sleep in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF|The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep. Participants rated overall sleep quality and their ability to function on scales ranging from “excellent” to “poor” and were asked to provide the number of nights they experienced RLS symptoms and the number of times/hours they awoke at night during the week prior to the measurement.|Randomization (Week 24) and Week 36 (or end of DB treatment)|Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.||participants|||Number
720511|NCT00311363|Secondary|Median Time to Onset of First RLS Symptoms Using the 24-hour RLS Symptom Record at Week 36 (DB Treatment Phase)|The 24-hour RLS Record is a diary in which participants report the presence and severity of RLS symptoms (none, mild, moderate, or severe) for a 24-hour period, in 30-min increments beginning at 8AM on the day prior to the visit. Note: The median is not estimable with Kaplan-Meier methodology when fewer than 50% of participants experience an event; thus, no data are presented for the DB GEn 1200 mg arm.|Week 36 (or end of DB treatment)|Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.||hours||95% Confidence Interval|Median
721032|NCT00317941|Other Pre-specified|Mean Scores of Reaction After Injection Reported by Patients Between Different Auto Injectors|Score range is: 0 - no abnormal reaction, 1 -erythema, 2-edema, 3-infiltration, 4-ulceration or necrosis|Up to 3 months|||Scores on a scale|Participants|Standard Deviation|Mean
720512|NCT00311363|Secondary|Number of Participants With no Reported RLS Symptoms (Sx) During Each of the 4-hour Periods From the 24-hour RLS Record at Week 36 (DB Treatment Phase)|In the 24-hour RLS Record (diary), participants report the presence and severity of RLS symptoms (none, mild, moderate, or severe) for a 24-hour period, in 30-minute increments. The period was divided into 7 four-hr intervals (8 AM to 12 PM, 12 to 4 PM, 4 to 8 PM, 6 to 10 PM, 8 to Midnight, Midnight to 4 AM, 4 to 8 AM)|Week 36 (or end of DB treatment)|Double-blind Intent-to-Treat (DB ITT) Population Participants who were missing severity scores for more than two 30-min windows during a 4-hour period had their maximum severity rating for the 4-hour period set to missing. At Randomization (Week 24), there was one participant in each arm with missing 24-hour RLS Record data.||participants|||Number
720513|NCT00311363|Secondary|Change From Randomization to Week 36 (DB Treatment Phase) in the RLS Quality of Life (QoL) Overall Life-Impact Score|The RLS QoL is an 18-item scale assessing the impact of RLS on daily life, emotional well-being, social and work life. Responses range from 1 (not at all/never) to 5 (a lot/all of the time). Ten items contribute to a single summary score, the Overall Life Impact, which is standardized to range from 0-100, with lower scores representing better QoL.|Randomization (Week 24) and Week 36 (or end of DB treatment)|Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.||points on a scale||Standard Deviation|Mean
720514|NCT00311363|Secondary|Change From Randomization to Week 36 (DB Treatment Phase) in the Mean Sleep Quantity Domain Score of the MOS Sleep Scale Using LOCF|The MOS Sleep Scale is a participant-rated non-disease-specific measure with questions relating to four areas related to sleep: quantity (number of hours slept), sleep disturbance, sleep adequacy, and daytime somnolence. The Sleep Quantity Domain score is a participant-rated estimate of the average number of hours of sleep per night over the month.|Randomization (Week 24) and Week 36 (or end of DB treatment)|Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.||hours||Standard Deviation|Mean
720515|NCT00311363|Secondary|Change From Randomization to Week 36 (DB Treatment Phase) in the Mean Sleep Adequacy Domain Score of the MOS Sleep Scale Using LOCF|The MOS Sleep Scale is a participant-rated non-disease-specific measure with questions relating to four areas related to sleep: quantity (number of hours slept), sleep disturbance, sleep adequacy, and daytime somnolence. The MOS Sleep Scale sleep adequacy domain is a participant-rated measure of the adequacy of sleep over the month prior to measurement. Questions are scored, and responses are converted to a 0 to 100 scale, with higher scores representing more adequate ratings of sleep.|Randomization (Week 24) and Week 36 (or end of DB treatment)|Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.||points on a scale||Standard Deviation|Mean
720516|NCT00311363|Secondary|Mean Change From Randomization to Week 36 (DB Treatment Phase) in the Mean Sleep Disturbance Domain Score of the MOS Sleep Scale Using LOCF|The MOS Sleep Scale is a participant-rated non-disease-specific measure with questions relating to four areas related to sleep: quantity (number of hours slept), sleep disturbance, sleep adequacy, and daytime somnolence. The MOS Sleep Scale sleep disturbance domain is a participant-rated measure of sleep disturbance over the month prior to the measurement. Questions are scored, and responses are converted to a 0 to 100 scale, with lower scores representing less sleep disturbance.|Randomization (Week 24) and Week 36 (or end of DB treatment)|Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.||points on a scale||Standard Deviation|Mean
720517|NCT00311363|Secondary|Mean Change From Randomization to Week 36 (DB Treatment Phase) in the Mean Daytime Somnolence Domain Score of the Medical Outcomes Study (MOS) Sleep Scale Using LOCF|The MOS Sleep Scale is a participant-rated non-disease-specific measure with questions relating to four areas related to sleep: quantity (hours slept), sleep disturbance, sleep adequacy, and daytime somnolence. Responses are recoded so that a higher score reflects more of the attribute, and then converted to a 0 to 100 scale. The daytime somnolence score is based on questions pertaining to feeling drowsy or sleepy, trouble staying awake, and taking naps > 5 minutes. For daytime somnolence, a negative value indicates an improvement.|Randomization (Week 24) and Week 36 (or end of DB treatment)|Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.||points on a scale||Standard Deviation|Mean
720518|NCT00311363|Secondary|Percentage of Participants Who Responded to Treatment Based on Scores on the Participant-Rated CGI-I at Week 36 (DB Treatment Phase) Using LOCF|"The participant-rated CGI-I scale is a self-rated assessment designed to allow participants to rate the change of their disease severity over time based on a seven-point scale, with a score of 1 being very much improved, and a score of 7 being very much worse. Response on the participant-rated CGI-I was defined as a rating of very much improved (score of 1) or much improved (score of 2) compared to Baseline of the SB phase."|Week 36 (or end of DB treatment)|Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.||percentage of participants|||Number
720529|NCT00311376|Primary|Change From Baseline in Number of Weekly Episodes of Urinary Incontinence|Change from baseline in the weekly frequency of incontinence episodes at Week 6 after the first treatment. Incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).|Baseline, Week 6|Intent-to-Treat defined as all patients who started the study (randomized)||Number of Weekly Episodes||Standard Deviation|Mean
720519|NCT00311363|Secondary|Number of Participants in Each Category of the Participant-Rated CGI-I Scale at Week 36 (DB Treatment Phase) Using LOCF|"The participant-rated CGI-I scale is a self-rated assessment designed to allow participants to rate the change of their disease severity over time based on a seven-point scale, with a score of 1 being “very much improved” and a score of 7 being “very much worse compared to baseline."|Week 36 (or end of DB treatment)|Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.||participants|||Number
720520|NCT00311363|Secondary|Number of Participants in Each Category of the Investigator-Rated CGI-C at Week 36 (DB Treatment Phase) Using LOCF|The CGI scale is a widely used tool designed to allow clinicians to rate the severity of illness and the change over time based on a seven-point rating scale, with a score of 1 being “very much improved” and a score of 7 being “very much worse” compared to baseline.|Randomization (Week 24) and Week 36 (or end of DB treatment)|Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.||participants|||Number
720521|NCT00311363|Secondary|Percentage of Participants Who Responded to Treatment Based on Scores on the Investigator-Rated Clinical Global Impression of Change (CGI-C) Scale as a Dichotomous Variable at Week 36 (DB Treatment Phase) Using LOCF|The CGI-C scale is a widely used tool designed to allow clinicians to rate the severity of illness and the change over time based on a seven-point rating scale, with a score of 1 being “very much improved” and a score of 7 being “very much worse” compared to baseline. For this endpoint, “response” on the CGI-C was defined as participants with a rating of “no change,” (score of 4) ”minimally improved,” (score of 3) “much improved,” (score of 2) or “very much improved” (score of 1) compared to Randomization (Week 24).|Randomization (Week 24) and Week 36 (or end of DB treatment)|Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.||percentage of participants|||Number
720522|NCT00311363|Secondary|Mean Change From Randomization to Week 36 (or End of Treatment) in the IRLS Rating Scale (IRLS) Total Score Using Last Observation Carried Forward (LOCF)|The IRLS Rating scale is a measure of RLS disease severity and reflects the participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. Items are included that assess the impact of symptoms on participants’ mood, daily life, and activities. The total score ranges from 0-40 points, with 40 being the most severe. The scale assesses symptoms over the week prior to measurement. LOCF: Missing data (MD) values were imputed using the last non-missing observation prior to the visit with MD; randomization visit data could be carried forward.|Randomization (Week 24) and Week 36 (or end of DB treatment)|Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.||points on a scale||Standard Deviation|Mean
720523|NCT00311363|Secondary|Time From Randomization to Relapse in RLS Symptoms During the Double-Blind Treatment Period (Excluding First Two Weeks of DB Phase)|Time to relapse was defined as the time until worsening of Restless Legs Syndrome (RLS) symptoms or withdrawal due to lack of efficacy during the 12-week Double-blind (DB) treatment period (same as primary outcome definition). Note: The median is not estimable with Kaplan-Meier methodology when fewer than 50% of participants experience an event. The median is not estimable for this outcome.|DB Treatment Period; Days 184 to 252 (Weeks 26 to 36)|DB ITT Population|||||
720524|NCT00311363|Secondary|Time From Randomization to Relapse in RLS Symptoms During the Double-Blind Treatment Period|Time to relapse was defined as the time until worsening of Restless Legs Syndrome (RLS) symptoms or withdrawal due to lack of efficacy during the 12-week Double-blind (DB) treatment period (same as primary outcome definition). Note: The median is not estimable with Kaplan-Meier methodology when fewer than 50% of participants experience an event. The median is not estimable for this outcome.|DB Treatment Period; Days 169 to 252 (Weeks 24 to 36)|DB ITT Population|||||
720525|NCT00311363|Primary|Percentage of Participants Who Experienced a Relapse During the Double-Blind Treatment Period|"Relapse was defined as worsening of Restless Legs Syndrome (RLS) symptoms or withdrawal due to lack of efficacy during the 12-week double-blind (DB) treatment period (the period from Randomization on Visit 14 [Week 24] through the end of treatment). Worsening of symptoms was defined as an increase in the total International RLS (IRLS) Scale score by at least 6 or more points relative to the participant's score at Randomization, achieving an IRLS score of at least 15, and an assessment of much worse or very much worse on the investigator-rated Clinical Global Impression of Change (CGI-C)."|DB Treatment Period; Days 169 to 252 (Weeks 24 to 36)|Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.||percentage of participants|||Number
720526|NCT00311376|Secondary|Change From Baseline in Total Score on Incontinence Quality of Life (I-QOL) Questionnaire|Change from baseline in I-QOL questionnaire total score at Week 6, as completed by the patient. The I-QOL is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure impact of urinary incontinence on patients’ lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). A positive change from baseline represents an improvement|Baseline, Week 6|Intent-to-Treat defined as all patients who started the study (randomized)||Number on a Scale (Score)||Standard Deviation|Mean
720541|NCT00311766|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)||70 days|The population for safety analysis included all patients who were randomized and received at least one dose of study medication and had at one safety parameter recorded.||Participants|||Number
720530|NCT00311402|Post-Hoc|Number of Patients With Composite Endpoint of Stroke or Major Bleeding|This is a composite endpoint of cerebral infarction, brain (cerebral) hemorrhage, subarachnoid haemorrhage and major bleeding. All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.|Up to 124 weeks|All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration.||patients|||Number
720531|NCT00311402|Post-Hoc|Number of Patients With Intracranial Haemorrhage|All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.|Up to 124 weeks|All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration.||patients|||Number
720532|NCT00311402|Post-Hoc|Number of Patients With Stroke|This is a composite endpoint of cerebral infarction, brain (cerebral) hemorrhage and subarachnoid haemorrhage. All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.|Up to 124 weeks|All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration.||patients|||Number
720533|NCT00311402|Secondary|Number of Patients With Ischemic Vascular Event Composite Endpoint|This is a composite endpoint of cerebral infarction, transient ischemic attack (TIA), acute myocardial infarction (MI), unstable angina and sudden death attributable to thromboembolism. All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.|Up to 124 weeks|All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration.||patients|||Number
720534|NCT00311402|Secondary|Number of Patients With Other Vascular Events|This endpoints were defined as pulmonary embolism, retinal vascular disorder, deep vein thrombosis, peripheral artery obstruction and vascular intervention. All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.|Up to 124 weeks|All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration.||patients|||Number
720535|NCT00311402|Secondary|Number of Patients With Acute Coronary Syndrome (ACS)|ACS contains acute myocardial infarction (MI), unstable angina and sudden cardiac death. All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.|Up to 124 weeks|All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration.||patients|||Number
720536|NCT00311402|Secondary|Number of Patients With Transient Ischemic Attack (TIA)|All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.|Up to 124 weeks|All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration.||patients|||Number
720537|NCT00311402|Secondary|Number of Patients With Subarachnoid Haemorrhage|All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.|Up to 124 weeks|All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration.||patients|||Number
720538|NCT00311402|Secondary|Number of Patients With Brain (Cerebral) Haemorrhage|All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.|Up to 124 weeks|All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration.||patients|||Number
720539|NCT00311402|Primary|Number of Patients With First Recurrent Cerebral Infarction (Fatal or Non-fatal)|All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.|Up to 124 weeks|All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration.||patients|||Number
720540|NCT00311584|Primary|Overall Response - Complete Response (CR), Very Good Partial Response (VGPR) and Partial Response (PR)|The patient’s best overall response obtained during Reporting Periods 1 and 2 will be scored as “best response”. Patients enrolled on Stratum 1 with bone marrow disease, a responder has no tumor cells detectable by routine morphology on 2 subsequent bilateral bone marrow aspirates and biopsies done at least 3 weeks apart. For patients enrolled on stratum 1 with MIBG only disease, response will be assessed using the Curie scale. Patients who have complete resolution of all MIBG positive lesions (CR) or resolution of at least one MIBG positive lesion with persistence of other lesions (PR) will be considered responders. For Stratum 2 a responder is defined to be a patient who achieves a best overall response of CR, VGPR or PR from CT/MRI scans from central review using (RECIST) Response Evaluation Criteria in Solid Tumor. A responder is defined to be a patient who achieves a best overall response of CR (Complete Response), VGPR (Very Good Partial Response) or PR (Partial Response).|up to 6 courses of therapy, or about 6 months|Patients were evaluable for inclusion in the analysis of response if eligible, had an event (relapse, PD, death or secondary malignancy) any time after enrollment, or completed at least 2 courses of Irinotecan/Temozolomide therapy. Patients off therapy before completion of 2 courses by choice or toxicity were not evaluable for response analysis.||participants|||Number
720543|NCT00312195|Secondary|The Amount of Rescue Medication Used for Pain (Average Daily Number of Acetaminophen Tablets).|The average daily acetaminophen (Panadol) use (1 tablet = 500 mg) during the double-blind phase was compared between the treatment groups using ANCOVA methodology with terms for country and treatment. The average escape medication used in the last 4 days prior to randomization was included as a covariate.|14 days|Full Analysis (N = 266) consisted of subjects who were randomized into the double-blind evaluation phase, were exposed to study drug, and provided at least 1 efficacy assessment during the double-blind evaluation phase.||Tablets||Standard Error|Least Squares Mean
720544|NCT00312195|Secondary|The Number of Subjects Who Had Ineffective Treatment or Who Discontinued Due to Reasons Other Than Ineffective Treatment in the Double-blind Phase|"Note: The total numbers of Subjects w/ineffective treatment or who discont'd for placebo and BTDS are 1 less because there were reasons other than lack of efficacy that made up this total: adverse event, death, lost to follow- up, protocol violation, and other. Example for placebo 89+5=94; however, 93 is indicated for the total because there is 1 subject in the placebo group who was counted under ineffective treatment and discontinued due to reasons other than lack of efficacy. The same is true for 1 subject in BTDS."|14 days|Full Analysis (N = 266) consisted of subjects who were randomized into the double-blind evaluation phase, were exposed to study drug, and provided at least 1 efficacy assessment during the double-blind evaluation phase.||participants|||Number
720545|NCT00312195|Secondary|Time (Days) From the Initial Dose of Study Drug in the Double-blind Evaluation Phase to Ineffective Treatment|"The time of ineffective treatment was calculated as the earliest of the following:
The date the subject first took >1 gram of acetaminophen,
The visit date when ineffective treatment was first determined, or
The date the last patch was removed."|14 days|Full Analysis (N = 266) consisted of subjects who were randomized into the double-blind evaluation phase, were exposed to study drug, and provided at least 1 efficacy assessment during the double-blind evaluation phase.||Days||Standard Error|Mean
720546|NCT00312195|Primary|The Number of Subjects With Ineffective Treatment During the Double-blind Evaluation Phase.|"Ineffective treatment was defined as:
Subject took >1 gram of acetaminophen in a 24-hour period, or
Subject required a change in transdermal patch (TDS) dose, or
Subject had difficulty in keeping the TDS on, or
Subject discontinued due to ineffective treatment (but did not meet any of the above criteria).
Note: some subjects may have had multiple reasons for ineffective treatment and are counted under each category. Therefore the sum of subjects across all criteria for ineffective treatment is greater than the total number of subjects with ineffective treatment."|Double-blind phase (14 days)|The Full Analysis Population (N = 266) for efficacy analyses included all subjects who were randomized and provided at least 1 efficacy assessment in the double-blind phase.||participants|||Number
720547|NCT00312208|Secondary|Death From Any Cause (Overall Survival)|The considered event is death from any cause. The analysis is performed on the time from randomization to this event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.|Median follow-up of 65 months|The analysis was performed on the Intent-to-Treat (ITT) population. Although the original Outcome Measure was intended to be presented as median survival time, median time-to-event was not reached in any group; therefore, number of participants who died was presented.||Participants|||Number
720548|NCT00312208|Primary|Local, Regional or Metastatic Relapse, or Second Primary Cancer, or Death From Any Cause (Disease-Free Survival)|The primary event is the local, regional or metastatic relapse or the date of second primary cancer or death from any cause (whichever occurs first). The primary efficacy analysis is performed on the time from randomization to this primary event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.|Median follow-up 65 months|The primary efficacy analysis was performed on the Intent-to-Treat (ITT) population. Although the original Outcome Measure was intended to be presented as median disease free survival time, median time-to-event was not reached in any group; therefore, number of participants with relapse was presented.||Participants|||Number
720549|NCT00312221|Secondary|The Sleep Disturbance Subscale in The Medical Outcomes (MOS)-Sleep Scale at Weeks 4, 8, and 12 of the Double-blind Phase|The MOS-Sleep Scale consists of 12 individual items: (4 sleep disturbance, 2 sleep adequacy, 1 quantity of optimal sleep, 3 somnolence, 1 snoring, and 1 shortness of breath) and takes 5 to 10 minutes to complete. Question 1 is scored on a scale of 1 to 5 and Questions 2 to 12 are scored on a scale of 1 to 6. The Sleep Disturbance Subscale score is derived from the scores to Questions 1, 3, 7 and 8, and ranges from 0 to 100, where higher scores indicate greater sleep disturbance.|Weeks 4, 8, and 12 of the Double-blind Phase|Full Analysis Population (N = 418) consisted of subjects who were randomized and received at least 1 dose of double-blind study drug.||Units on a scale||Standard Error|Mean
720550|NCT00312221|Secondary|The Physical Function Subscale of The Western Ontario and McMaster's Universities Osteoarthritis (WOMAC OA) Index at Weeks 4, 8, and 12 of the Double Blind Phase|"The WOMAC (Version LK 3.1) measures symptoms and physical functioning of patients with OA of the hip and knee. It contains 24 items (5 pain, 2 stiffness, 17 physical function) and takes less than 5 minutes to complete.
The WOMAC physical function subscale has 17 items coded as 0 to 4 (best to worst), which are summed, giving a range of 0 to 68 (best to worst)."|Weeks 4, 8 and 12 of the double-blind phase|Full Analysis Population (N = 418) consisted of subjects who were randomized and received at least 1 dose of double-blind study drug.||Units on a scale||Standard Error|Mean
720551|NCT00312221|Secondary|The Mean Daily Number of Supplemental Analgesic Medication Tablets|The mean daily number of supplemental analgesic medication tablets included sponsor-supplied ibuprofen, acetaminophen, or OxyIR®.|Double-blind phase (84 days)|Full Analysis Population (N = 418) consisted of subjects who were randomized and received at least 1 dose of double-blind study drug.||Tablets||Standard Error|Mean
720552|NCT00312221|Primary|“Average Pain Over the Last 24 Hours” Scores at Weeks 4, 8, and 12 of the Double-blind Phase.|The “average pain over the last 24 hours” score was collected using an 11-point numerical scale ranging from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. This variable was obtained at each clinic visit during the double-blind phase of the study (postrandomization weeks 1, 2, 4, 8, and 12).|Weeks 4, 8, and 12 of the double-blind phase|Full Analysis Population (N = 418) consisted of subjects who were randomized and received at least 1 dose of double-blind study drug.||Units on a scale||Standard Error|Mean
721033|NCT00317941|Primary|Mean Scores of Reaction After Injection Reported by Participants|Score range is: 0 - no abnormal reaction, 1 -erythema, 2-edema, 3-infiltration, 4-ulceration or necrosis|Up to 3 months assessed every 24 and 48 hours after injection|||Scores on a scale|Participants|Standard Deviation|Mean
720554|NCT00312338|Primary|Susceptability Changes in Staphylococcus Aureus Distal to the Site of Instillation|"Susceptibility change refers to a change in vulnerability of a specified bacterial strain to antibiotic treatment. Susceptibility was assessed by broth microdilution methods recommended by the Clinical and Laboratory Standards Institute (CLSI).
0% = zero isolates were resistant to antibiotic 100% = all isolates were resistant to antibiotic"|Day 0, Day 42|||Percent of resistant isolates|||Number
720555|NCT00312338|Primary|Susceptability Changes in Streptococcus Pneumoniae Distal to the Site of Instillation|"Susceptibility change refers to a change in vulnerability of a specified bacterial strain to antibiotic treatment. Susceptibility was assessed by broth microdilution methods recommended by the Clinical and Laboratory Standards Institute (CLSI).
0% = zero isolates were resistant to antibiotic 100% = all isolates were resistant to antibiotic"|Day 0 and Day 42|||Percent of resistant isolates|||Number
720556|NCT00312377|Secondary|Time to Deterioration of Disease-related Symptoms (TDS) by FACT-L Pulmonary Symptom Index (PSI)|"The pulmonary symptom index (PSI) consists of 4 items of the LCS relating to pulmonary symptoms (i.e. 3 items relating to breathing/dyspnea, and 1 item relating to cough). The PSI score is the sum of the scores from the 4 items.
Time to deterioration is defined as the interval from the date of randomization to the first assessment of worsened without an improvement in the next 21 days.
A patient will be defined as having a deterioration in symptoms if they have a single visit assessment of ‘worsened’ with no visit assessment of ‘improved’ within the next 21 days."|FACT-L questionnaires are to be administered every 3 weeks after randomisation|||Weeks||Inter-Quartile Range|Median
720557|NCT00312377|Secondary|Time to Deterioration of Disease-related Symptoms (TDS) by Functional Assessment of Cancer Therapy - Lung (FACT-L) Lung Cancer Subscale (LCS).|"The lung cancer subscale (LCS) consists of 7 items of the FACT-L (3 items relating to breathing/dyspnea, and 1 item each relating to cough, weight loss, appetite, and cognition). The LCS total score is the sum of the scores from the 7 items.
Time to deterioration is defined as the interval from the date of randomization to the first assessment of worsened without an improvement in the next 21 days.
A patient will be defined as having a deterioration in symptoms if they have a single visit assessment of ‘worsened’ with no visit assessment of ‘improved’ within the next 21 days."|FACT-L questionnaires are to be administered every 3 weeks after randomisation|||Weeks||Inter-Quartile Range|Median
720558|NCT00312377|Secondary|Duration of Response (DoR)|Response is defined as a confirmed best objective response of CR or PR. Duration of response is defined as time from the date of first documented response until date of documented progression or death in the absence of disease progression (provided death is within 3 months of last RECIST assessment)|RECIST tumour assessments carried out every 6 weeks from randomisation until objective progression|||Weeks||Full Range|Median
720559|NCT00312377|Secondary|Disease Control Rate (DCR)|Disease control rate is defined as the number of patients who achieved disease control at least 6 weeks following randomisation. Disease control at 6 weeks is defined as a best objective response of complete response (CR), partial response (PR) or stable disease (SD) >= 6 weeks as determined according to RECIST 1.0. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere, PR is defined as at least a 30% reduction in the total tumour size of measurable lesions with no new lesions and no progression in the non-target lesions and SD >= 6 is assigned to patients who have not responded and have no evidence of progression at least 6 weeks after randomisation.|RECIST tumour assessments carried out every 6 weeks from randomisation until objective progression|||Participants|||Number
720560|NCT00312377|Secondary|Objective Response Rate (ORR)|The ORR is the number of patients that are responders ie those patients with a confirmed best objective response of complete response (CR) or partial response (PR) as determined according to RECIST 1.0. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere and PR is defined as at least a 30% reduction in the total tumour size of measurable lesions with no new lesions and no progression in the non-target lesions.|Each patient was assessed for objective response from the sequence of RECIST scan data up to data cut off. RECIST tumour assessments carried out every 6 weeks from randomisation until objective progression|||Participants|||Number
720561|NCT00312377|Secondary|Overall Survival (OS) in the Female Population|Overall survival is defined as the time from date of randomization until death. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive (ie their status must be known at the censored date and should not be lost to follow up or unknown).|Time to death in months|||Months||95% Confidence Interval|Median
720562|NCT00312377|Secondary|Overall Survival (OS) in the Overall Population|Overall survival is defined as the time from date of randomization until death. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive (ie their status must be known at the censored date and should not be lost to follow up or unknown).|Time to death in months|||Months||95% Confidence Interval|Median
720563|NCT00312377|Primary|Progression-Free Survival (PFS) in the Female Population|Median time (in weeks) from randomisation until objective disease progression or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment. Progression was derived according to RECIST 1.0 and is defined as an increase of at least 20% in the total tumour size of measurable lesions over the nadir measurement, unequivocal progression in the non-target lesions or the appearance of one or more new lesions.|RECIST tumour assessments carried out every 6 weeks from randomisation until the date of first documented objective disease progression or date of death from any cause, whichever came first assessed up to 24 months|||Weeks||95% Confidence Interval|Median
720564|NCT00312377|Primary|Progression-Free Survival (PFS) in the Overall Population|Median time (in weeks) from randomisation until objective disease progression or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment. Progression was derived according to RECIST 1.0 and is defined as an increase of at least 20% in the total tumour size of measurable lesions over the nadir measurement, unequivocal progression in the non-target lesions or the appearance of one or more new lesions.|RECIST tumour assessments carried out every 6 weeks from randomisation until the date of first documented objective disease progression or date of death from any cause, whichever came first assessed up to 24 months|||Weeks||95% Confidence Interval|Median
721048|NCT00318409|Primary|Acceptability: Proportion of Participants Discontinuing Medication in Both Arms|Proportion of participants who discontinued study medication for at least one week prior to study completion.|12 weeks|||percentage of discontinuations|||Number
720566|NCT00312494|Secondary|Change From Baseline in Longitudinal Interval Follow-up Evaluation Range of Impaired Functioning (LIFE-RIFT) Score|LIFE-RIFT measures severity of illness-related impairment in 4 domains: work, interpersonal relations, recreation, and global satisfaction; has a total score and individual domain scores. Domain scores range from 1 to 5 (scores ≥ 2 reflect impaired functioning). Total score is sum of the 4 domains with range of 4 (very good) to 20 (very poor): higher scores indicate greater impairment. Change calculated as mean of (value of LIFE-RIFT score at observation minus baseline value).|Baseline, Week 3|ITT population excluding data from 2 sites that were closed due to GCP deviations.||scores on scale||Standard Error|Least Squares Mean
720567|NCT00312494|Secondary|Change From Baseline in Global Assessment of Functioning (GAF) Score|GAF measures the severity of illness-related impairment in psychological, social, and occupational functioning; rated on a 100-point scale (single score of 1 to 100) with 100 indicating superior functioning. Change calculated as mean of (value of GAF score at observation minus baseline value).|Baseline, Week 3|ITT population excluding data from 2 sites that were closed due to GCP deviations.||scores on scale||Standard Error|Least Squares Mean
720568|NCT00312494|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Score|PANSS is a 30-item scale to measure severity of psychopathology (16 items); positive scale (7 items); negative scale (7 items); summarized as positive score, negative score, and total score. Scores rated 1 (absent symptoms) to 7 (extreme); total score range 30 to 210: higher score indicates greater severity. Change calculated as mean of (value of PANSS score at observation minus baseline value).|Baseline, Week 3|ITT population excluding data from 2 sites that were closed due to GCP deviations; (n)=number of subjects for ziprasidone (higher dose), ziprasidone (lower dose), and placebo, respectively.||scores on scale||Standard Error|Least Squares Mean
720569|NCT00312494|Secondary|Clinical Global Impression - Improvement (CGI-I) Scale Scores|CGI-I is a single-item clinician rated scale used to assess global improvement in the subject's clinical state (bipolar mania) in response to study treatment and as compared to their status at pre-treatment baseline. Scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse); higher score = more affected.|Week 1, Week 2, Week 3|ITT population excluding data from 2 sites that were closed due to GCP deviations; (n)=number of subjects for ziprasidone (higher dose), ziprasidone (lower dose), and placebo, respectively.||scores on scale||Standard Error|Least Squares Mean
720570|NCT00312494|Secondary|Change From Baseline in Clinical Global Impression Scale - Severity (CGI-S) Score|CGI-S is a single-item clinician rated scale used to assess global severity of bipolar illness based on an overall evaluation of symptoms of bipolar mania, associated behavioral symptoms, and condition of the subject. Rating ranges from 1 (normal, not at all ill) to 7 (among the most severely ill subjects); higher score = more affected. Change calculated as mean of (value of CGI-S score at observation minus baseline value).|Baseline, Week 1, Week 2, Week 3|ITT population excluding data from 2 sites that were closed due to GCP deviations; (n)=number of subjects for ziprasidone (higher dose), ziprasidone (lower dose), and placebo, respectively.||scores on scale||Standard Error|Least Squares Mean
720571|NCT00312494|Secondary|Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Scores|MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts); rated on a 7-point Likert scale 0 (normal) to 6 (most abnormal) with anchors at 2-point intervals; total score 0 to 44 (higher score indicates greater severity of symptoms). Change calculated as mean of (value of MADRS score at observation minus baseline value).|Baseline, Week 1, Week 2, Week 3|ITT population excluding data from 2 sites that were closed due to GCP deviations; (n)=number of subjects for ziprasidone (higher dose), ziprasidone (lower dose), and placebo, respectively.||scores on scale||Standard Error|Least Squares Mean
720572|NCT00312494|Secondary|Change From Baseline to Week 1 and Week 2 in YMRS|YMRS is an 11-item scale (elevated mood, increased motor activity-energy, sexual interest, sleep, irritability, speech [rate and amount], language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight) used to assess the severity of manic symptoms and effect of treatment on mania severity. Seven items ranked on scale from 0 to 4; 4 items ranked 0 to 8. Total possible score 0 to 60: higher scores indicate greater severity. Change calculated as mean of (value of YMRS score at observation minus baseline value).|Baseline, Week 1, Week 2|ITT population excluding data from 2 sites that were closed to GCP deviations; (n)=number of subjects for ziprasidone (higher dose), ziprasidone (lower dose), and placebo, respectively.||scores on scale||Standard Error|Least Squares Mean
720573|NCT00312494|Primary|Change From Baseline to Week 3 in Young Mania Rating Scale (YMRS)|YMRS is an 11-item scale (elevated mood, increased motor activity-energy, sexual interest, sleep, irritability, speech [rate and amount], language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight) used to assess the severity of manic symptoms and effect of treatment on mania severity. Seven items ranked on scale from 0 to 4; 4 items ranked 0 to 8. Total possible score 0 to 60: higher scores indicate greater severity. Change calculated as mean of (value of YMRS score at observation minus baseline value).|Baseline, Week 3|Intent to Treat population (ITT): all randomized subjects who received at least 1 dose of double-blind medication, who had 1 baseline and at least 1 post-baseline primary efficacy evaluation; excluding data from 2 sites that were closed due to Good Clinical Practices (GCP) deviations.||scores on scale||Standard Error|Least Squares Mean
720574|NCT00312572|Primary|The Percentage of Subjects Who Completed the 14-day Double-blind Phase.|The indicator variable was 1 = completion, and 0 = noncompletion. For the primary efficacy analysis, the percentage of subjects who completed the double-blind phase was computed with its 95% confidence interval (CI) for each treatment regimen (starting dose of BTDS 10 or BTDS 20) across and within baseline Vicodin® stratum (15 to 22.5mg/day vs >22.5 to 30 mg/day as determined by the daily average hydrocodone dose during the run-in period).|14 days|Full Analysis Population: (N = 198) consisted of all subjects who were randomized into the double-blind phase, received at least 1 dose of BTDS during the double-blind phase, and had at least 1 efficacy observation during the double-blind phase, and had no evidence of impaired liver function at screening and prerandomization.||Percentage of Participants||95% Confidence Interval|Number
720642|NCT00313170|Secondary|Pharmacokinetic Parameter: Mean Population Clearance, a Measure of the Efficiency With Which Fulvestrant is Eliminated From the Body|The measure of dispersion for mean population clearance is based on the estimated inter-individual variance.|Baseline to 12 weeks|Participants who had PK samples only||litres per hour||Standard Deviation|Mean
720575|NCT00312728|Secondary|Number of Participants With Selected Adverse Events|"Number of participants with selected adverse events (all grades based on NCI CTCAE) included any grade CNS hemorrhage, any grade pulmonary hemorrhage, any grade gastrointestinal (GI) perforation, Grade ≥ 2 arterial thromboembolic event, Grade ≥ 2 left ventricular systolic dysfunction, Grade ≥ 3 non-CNS non-pulmonary hemorrhage, Grade ≥ 3 proteinuria, Grade ≥ 3 proteinuria, Grade ≥ 3 hypertension, any serious adverse event*, and any adverse event leading to study treatment discontinuation.
*For serious adverse events, please see Adverse Event Reporting Section."|From start of bevacizumab treatment to 60 days following discontinuation of bevacizumab (up to 2 years)|The safety-evaluable population consisted of all patients who received at least one dose of bevacizumab.||participants|||Number
720576|NCT00312728|Secondary|Number of Participants With OS in First-line and Second-line Settings [1−Year or More Survival]|To assess the number of participants with overall survival in the subset of subjects treated in the first-line setting with bevacizumab plus either chemotherapy or erlotinib for non-squamous NSCLC with previously treated brain metastases.|Time from enrollment to death from any cause (up to 2 years)|The efficacy-evaluable population consisted of all patients who received at least one dose of bevacizumab.||participants|||Number
720577|NCT00312728|Secondary|OS in First-line and Second-line Settings|To assess overall survival in the subset of subjects treated in the first-line setting with bevacizumab plus either chemotherapy or erlotinib for non-squamous NSCLC with previously treated brain metastases.|Time from enrollment to death from any cause (up to 2 years)|The efficacy-evaluable population consisted of all patients who received at least one dose of bevacizumab.||Months||95% Confidence Interval|Median
720578|NCT00312728|Secondary|Number of Participants With Overall Survival (OS) in First-line Setting [1−Year or More Survival]|Number of Participants with overall survival in the subset of subjects treated in the first-line setting with bevacizumab plus either chemotherapy or erlotinib for non-squamous NSCLC with previously treated brain metastases.|Time from enrollment to death from any cause (up to 2 years)|The first-line efficacy-evaluable population consisted of 70 patients who received at least one dose of bevacizumab.||participants|||Number
720579|NCT00312728|Secondary|Overall Survival (OS) in First-line Setting|To assess overall survival in the subset of subjects treated in the first-line setting with bevacizumab plus either chemotherapy or erlotinib for non-squamous NSCLC with previously treated brain metastases.|Time from enrollment to death from any cause (up to 2 years)|The first-line efficacy-evaluable population consisted of 70 patients who received at least one dose of bevacizumab.||Months||95% Confidence Interval|Median
720580|NCT00312728|Primary|Percentage of Participants With Symptomatic National Cancer Institute's Common Terminology Criteria for Adverse Events v3.0 (NCI CTCAE) Grade ≥2 Central Nervous System (CNS) Hemorrhage|"The percentage of participants with symptomatic NCI CTCAE Grade ≥ 2 CNS hemorrhage, defined as the presence of clinical symptoms determined by the investigator to be directly referable to a Grade ≥ 2 CNS hemorrhage.
Grade 1: Asymptomatic, radiographic findings only Grade 2: Medical intervention indicated Grade 3: Ventriculostomy, intracranial pressure (ICP) monitoring, intraventricular thrombolysis, or operative intervention indicated Grade 4: Life-threatening consequences; neurologic deficit or disability Grade 5: Death"|From the first administration of bevacizumab until 60 days after discontinuation of bevacizumab treatment was reported (up to 2 years)|The safety-evaluable population consisted of all patients who received at least one dose of bevacizumab.||percentage of participants||90% Confidence Interval|Number
720581|NCT00312845|Secondary|Overall Response Rate|Overall response rate is defined as Complete Response (CR) + Complete Response Unconfirmed (CRu) + Partial Response (PR) using International Working Group Criteria (IWGC) and Independent Radiographic Review results and clinical results. The IWGC CR requires complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms, and normalization of lactic dehydrogenase and bone marrow involvement. CRu requires more than 75% reduction in sum of product of nodes (SPD). PR requires moer than 50% reduction in SPD.|Subjects are followed until progressive disease/death or the end of the study. The median follow up time is 33.9 months.|The response-evaluable population was defined as all subjects in the ITT population who received at least 1 dose of VELCADE or rituximab, had at least 1 measurable tumor mass (>1.5 cm in the longest dimension and >1.0 cm in the short axis) at baseline, and had at least 1 post-baseline disease assessment by independent radiology reviewers/IRC.||participants|||Number
720582|NCT00312845|Primary|Progression Free Survival|Progression free survival is defined as time from randomization to progressive disease or death due to any cause, whichever occurs first.|Subjects are followed until progressive disease/death or the end of the study. The median follow up time is 33.9 months.|Intention to treat (ITT) population is defined as all patients randomized to the trial.||days||95% Confidence Interval|Median
720583|NCT00312858|Other Pre-specified|Antibody Response to S. Pneumoniae Serotype 23F - Participants With a Serological Response|Number of participants with a postvaccination titer >=0.2 mcg/mL for S. pneumoniae serotype 23F|6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)|Per-protocol analysis set includes participants who received Prevnar™ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures. Serotype 23F is one of 7 individual serotypes contained in Prevnar™.||Participants|||Number
720584|NCT00312858|Other Pre-specified|Antibody Response to S. Pneumoniae Serotype 19F - Participants With a Serological Response|Number of participants with a postvaccination titer >=0.2 mcg/mL for S. pneumoniae serotype 19F|6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)|Per-protocol analysis set includes participants who received Prevnar™ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures. Serotype 19F is one of 7 individual serotypes contained in Prevnar™.||Participants|||Number
720585|NCT00312858|Other Pre-specified|Antibody Response to S. Pneumoniae Serotype 18C - Participants With a Serological Response|Number of participants with a postvaccination titer >=0.2 mcg/mL for S. pneumoniae serotype 18C|6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)|Per-protocol analysis set includes participants who received Prevnar™ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures. Serotype 18C is one of 7 individual serotypes contained in Prevnar™.||Participants|||Number
720699|NCT00302003|Secondary|Overall Survival|Survival is defined as time from study entry to death due to any cause. Patients alive at last contact where censored at last contact.|At 60 months|Eligible (n=278). Follow-up for censored patients (n=277) is 76 months (range: 4.7 to 109 months).||Probability of survival||95% Confidence Interval|Number
720586|NCT00312858|Other Pre-specified|Antibody Response to S. Pneumoniae Serotype 14 - Participants With a Serological Response|Number of participants with a postvaccination titer >=0.2 mcg/mL for S. pneumoniae serotype 14|6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)|Per-protocol analysis set includes participants who received Prevnar™ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures. Serotype 14 is one of 7 individual serotypes contained in Prevnar™.||Participants|||Number
720587|NCT00312858|Other Pre-specified|Antibody Response to S. Pneumoniae Serotype 9V - Participants With a Serological Response|Number of participants with a postvaccination titer >=0.2 mcg/mL for S. pneumoniae serotype 9V|6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)|Per-protocol analysis set includes participants who received Prevnar™ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures. Serotype 9V is one of 7 individual serotypes contained in Prevnar™.||Participants|||Number
720588|NCT00312858|Other Pre-specified|Antibody Response to S. Pneumoniae Serotype 6B - Participants With a Serological Response|Number of participants with a postvaccination titer >=0.2 mcg/mL for S. pneumoniae serotype 6B|6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)|Per-protocol analysis set includes participants who received Prevnar™ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures. Serotype 6B is one of 7 individual serotypes contained in Prevnar™.||Participants|||Number
720589|NCT00312858|Other Pre-specified|Antibody Response to S. Pneumoniae Serotype 4 - Participants With a Serological Response|Number of participants with a postvaccination titer >=0.2 mcg/mL for S. pneumoniae serotype 4|6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)|Per-protocol analysis set includes participants who received Prevnar™ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures. Serotype 4 is one of 7 individual serotypes contained in Prevnar™.||Participants|||Number
720590|NCT00312858|Other Pre-specified|Antibody Response to Varicella - Geometric Mean Titer|Geometric Mean Titer of varicella antibody, baseline antibody titer was <1.25 gpELISA units/mL|6 weeks Postdose 1 of varicella-containing vaccine (ProQuad™)|Per-protocol analysis set includes participants who received the initial dose of ProQuad™ (varicella-containing vaccine), had a Postdose 1 serology result, and followed the protocol procedures||gpELISA units/mL||95% Confidence Interval|Geometric Mean
720591|NCT00312858|Other Pre-specified|Antibody Response to Hepatitis A – Geometric Mean Titer|Geometric Mean Titer of hepatitis A antibody, regardless of initial serostatus|4 weeks Postdose 2 of hepatitis A vaccine (VAQTA™)|Per-protocol analysis set includes participants who received 2 doses of VAQTA™ (hepatitis A vaccine), had a Postdose 2 serology results, and followed the protocol procedures||mIU/mL||95% Confidence Interval|Geometric Mean
720592|NCT00312858|Primary|Participants With 1 or More Serious Vaccine-related Adverse Experience|Serious vaccine-related adverse experience causes death, persistent or significant disability, causes or prolong a hospital stay, is a cancer, an overdose, or life-threatening. They were collected during the entire study and believed due to study vaccine|6 months|Includes all participants who provided safety follow-up after receipt of any dose of VAQTA™ (hepatitis A vaccine)||Participants|||Number
720593|NCT00312858|Primary|Participants With 1 or More Serious Vaccine-related Adverse Experience|Serious vaccine-related adverse experience causes death, persistent or significant disability, causes or prolong a hospital stay, is a cancer, an overdose, or life-threatening. They were collected during the entire study and believed due to study vaccine|4 weeks post dose 2|Includes all participants who provided safety follow-up after receipt of Dose 2 of VAQTA™ (hepatitis A vaccine)||Participants|||Number
720594|NCT00312858|Primary|Participants With 1 or More Serious Vaccine-related Adverse Experience|Serious vaccine-related adverse experience causes death, persistent or significant disability, causes or prolong a hospital stay, is a cancer, an overdose, or life-threatening. They were collected during the entire study and believed due to study vaccine|6 weeks post dose 1|Includes all participants who provided safety follow-up after receipt of Dose 1 of VAQTA™ (hepatitis A vaccine)||Participants|||Number
720595|NCT00312858|Primary|Participants With Elevated Temperature (≥102.2F/ ≥39.0C)|Elevated temperatures measured the first 5 days after receipt of each dose of hepatitis A vaccine (VAQTA™) (Days 1 to 5) over the 6 months in which the 2 doses of vaccine were administered.|6 months|Includes all participants who provided safety follow-up after receipt of any dose of VAQTA™ (hepatitis A vaccine)||Participants|||Number
720596|NCT00312858|Primary|Participants With Elevated Temperature (≥102.2F/ ≥39.0C)|Elevated temperatures measured the first 5 days after receipt of dose 2 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 4 week study period.|4 weeks post dose 2|Includes all participants who provided safety follow-up after receipt of Dose 2 of VAQTA™ (hepatitis A vaccine)||Participants|||Number
720597|NCT00312858|Primary|Participants With Elevated Temperature (≥102.2F/ ≥39.0C)|Elevated temperatures measured the first 5 days after receipt of dose 1 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 6 week study period.|6 weeks post dose 1|Includes all participants who provided safety follow-up after receipt of Dose 1 of VAQTA™ (hepatitis A vaccine)||Participants|||Number
720598|NCT00312858|Primary|Participants With 1 or More Injection-site Adverse Experience|Injection-site adverse experiences collected the first 5 days after receipt of each dose of hepatitis A vaccine (VAQTA™) (Days 1 to 5) over the 6 months in which the 2 doses of vaccine were administered.|6 months|Includes all participants who provided safety follow-up after receipt of any dose of VAQTA™ (hepatitis A vaccine)||Participants|||Number
720599|NCT00312858|Primary|Participants With 1 or More Injection-site Adverse Experience|Injection-site adverse experiences collected the first 5 days after receipt of dose 2 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 4 week study period.|4 weeks post dose 2|Includes all participants who provided safety follow-up after receipt of Dose 2 of VAQTA™ (hepatitis A vaccine)||Participants|||Number
720600|NCT00312858|Primary|Participants With 1 or More Injection-site Adverse Experience|Injection-site adverse experiences collected the first 5 days after receipt of dose 1 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 6 week study period.|6 weeks post dose 1|Includes all participants who provided safety follow-up after receipt of Dose 1 of VAQTA™ (hepatitis A vaccine)||Participants|||Number
721049|NCT00318409|Primary|Acceptability: Adherence to Daily Bupropion and Placebo, as Determined by Self-report|Proportional of reported days taking study drug during the 12 weeks of study.|12 weeks|||percentage of self-reported adherence|||Number
720602|NCT00312858|Primary|Participants With 1 or More Systemic Adverse Experience|Systemic adverse experiences are unfavorable or unintended changes in the body after getting study vaccine. They are collected the first 14 days after receipt of dose 2 of hepatitis A vaccine (VAQTA™) (Days 1 to 14) within the 4 week study period.|4 weeks post dose 2|Includes all participants who provided safety follow-up after receipt of Dose 2 of VAQTA™ (hepatitis A vaccine)||Participants|||Number
720603|NCT00312858|Primary|Participants With 1 or More Systemic Adverse Experience|Systemic adverse experiences are unfavorable or unintended changes in the body after getting study vaccine. They are collected the first 14 days after receipt of dose 1 of hepatitis A vaccine (VAQTA™) (Days 1 to 14) within the 6 week study period.|6 weeks post dose 1|Includes all participants who provided safety follow-up after receipt of Dose 1 of VAQTA™ (hepatitis A vaccine)||Participants|||Number
720604|NCT00312858|Primary|Antibody Response to Streptococcus Pneumoniae - Geometric Mean Titers|Serum antibodies to serotype-specific pneumococcal polysaccharides were determined by enzyme-linked immunosorbent assay|6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)|Per-protocol analysis set includes participants who received Prevnar™ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures||mcg/mL||95% Confidence Interval|Geometric Mean
720605|NCT00312858|Primary|Antibody Response to Varicella - Participants With a Serological Response|Participants with varicella baseline antibody titer <1.25 gpELISA units/mL and Postdose 1 titers ≥1.25 gpELISA units/mL (seroconversion) and ≥5 gpELISA units/mL (seroprotection)|6 weeks Postdose 1 of varicella-containing vaccine (ProQuad™)|Per-protocol analysis set includes participants who received the initial dose of ProQuad™ (varicella-containing vaccine), had a Postdose 1 serology result, and followed the protocol procedures.||Participants|||Number
720606|NCT00312858|Primary|Antibody Response to Hepatitis A - Participants With a Serological Response|Number of participants with titer ≥10 mIU/mL, i.e., seropositive for hepatitis A antibody, regardless of initial serostatus|4 weeks Postdose 2 of hepatitis A vaccine (VAQTA™)|Per-protocol analysis set includes participants who received 2 doses of VAQTA™ (hepatitis A vaccine), had a Postdose 2 serology results, and followed the protocol procedures.||Participants|||Number
720607|NCT00312884|Primary|Number of Hospitalisations (All Cause)||from randomisation for 180 days|||Number of hospitalisations|||Number
720608|NCT00312884|Primary|Number of Days Spent in Hospital||From randomisation date for 180 days|||days||Inter-Quartile Range|Median
720609|NCT00312884|Primary|Patients Hospitalised (All Cause)||From randomisation date to 180 days|||participants|||Number
720610|NCT00312884|Primary|Days Alive and Outside of Hospital|Days alive and outside of hospital (i.e. not admitted)|From date of randomisation for 180 days|||Days||Inter-Quartile Range|Median
720611|NCT00312923|Secondary|Triglycerides||12 weeks|||mg/dl||Standard Deviation|Mean
720612|NCT00312923|Primary|LDL Cholesterol|Low density lipoprotein cholesterol|12 weeks|||mg/dl||Standard Deviation|Mean
720613|NCT00313014|Secondary|The Sleep Disturbance Subscale in the MOS-Sleep Scale at Weeks 4, 8, and 12.|"The MOS-Sleep Scale consists of 12 individual items: (4 sleep disturbance, 2 sleep adequacy, 1 quantity/ optimal sleep, 3 somnolence, 1 snoring, and 1 shortness of breath).
Question 1 is scored on a scale of 1 to 5 and Questions 3 to 12 are scored on a scale of 1 to 6. The Sleep Disturbance Subscale score is derived from the scores to Questions 1, 3, 7 and 8, and ranges from 0 to 100, where higher scores indicate greater sleep disturbance."|Weeks 4, 8, 12 of the double-blind phase|Full Analysis Population (N = 660) consisted of subjects who were randomized and received at least 1 dose of double-blind study drug.||units on a scale||Standard Error|Mean
720614|NCT00313014|Secondary|Oswestry Disability Index (ODI) Score (V 2.0)|"The ODI (version 2) is a low back pain-specific, validated instrument that consists of questions related to limitations in performing specific activities of daily living and 1 question related to pain intensity. The ODI is a self-administered questionnaire that is usually completed in less than 5 minutes.
The ODI consists of 10 sections. Each section consists of 6 statements ranked from 0 to 5 (0 = good to 5 = worse). (Note: A higher score represents greater disability.)"|Weeks 4, 8, 12|Full Analysis Population (N = 660) consisted of subjects who were randomized and received at least 1 dose of double-blind study drug.||units on a scale||Standard Error|Mean
720615|NCT00313014|Secondary|Mean Daily Number of Supplemental Analgesic Tablets|The mean daily number of tablets of supplemental analgesic medications used during the double-blind phase|Double-blind phase (84 days)|Full Analysis Population (N = 660) consisted of subjects who were randomized and received at least 1 dose of double-blind study drug.||tablets||Standard Error|Mean
720616|NCT00313014|Primary|Average Pain Over the Last 24 Hours Score at Weeks 4, 8, and 12.|"Subjects were evaluated during the double-blind phase for average pain over the last 24 hours prior to the study visits. Pain scale is 11 points (0 = no pain to 10 = pain as bad as you can imagine)"|Last 24 hours score at weeks 4, 8, 12 of the double-blind phase|Full Analysis Population (N = 660) consisted of subjects who were randomized and received at least 1 dose of double-blind study drug.||units on a scale||Standard Error|Mean
720617|NCT00313144|Secondary|ARALAST Antibody Titers: Participants With at Least 2-Dilution Step Increases From Screening|"All IgG and IgM titers at screening were ≤ 4. A 2-dilution step increase was defined as follows:
The titer at each 6-month visit must be ≥ 4 when the screening titer = 0
Each 6-month visit titer / screening titer should be ≥ 4. 6 month window periods are: baseline to ≤6 months, >6 months to ≤12 months, >12 months to ≤18 months, and >18 months to ≤24 months"|Baseline to 24 Months|Subjects who participated in the blood draws with data available during each window period||Participants|||Number
720618|NCT00313144|Secondary|Renal and Hepatic Chemistry Parameters: Change From Baseline/Screening|Summary of changes in hepatic (total bilirubin) and renal (Blood urea nitrogen (BUN), creatinine) parameters from screening/baseline through each window period (Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months)|Baseline to 24 months|Subjects who participated in the blood draws with data available during each window period||mg/dL||Full Range|Median
720619|NCT00313144|Secondary|Hepatic Chemistry Parameters: Change From Baseline/Screening|Summary of changes in hepatic (total bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase) parameters from screening/baseline through each window period (Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months)|Baseline to 24 months|Subjects who participated in the blood draws with data available during each window period||U/L||Full Range|Median
720620|NCT00313144|Secondary|Healthcare Resource Utilization (HCRU) 'Number of Steroid Pulse Courses'|Number of steroid pulse courses (i.e. number of steroid prescriptions) one year prior to baseline/screening, and during each window period (Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months)|One year prior to baseline to 24 months post-baseline|Participants with data available during each window period||Steroid Pulse Courses||Standard Deviation|Mean
720621|NCT00313144|Secondary|Healthcare Resource Utilization (HCRU) 'Number of Participants Receiving Steroid Pulse Courses'|Number of participants receiving steroid pulse courses (i.e. number of steroid prescriptions) one year prior to baseline/screening, and during each window period (Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months)|One year prior to baseline to 24 months post-baseline|Participants with data available during each window period||Participants|||Number
720622|NCT00313144|Secondary|Healthcare Resource Utilization (HCRU) 'Number of Antibiotic Courses'|Number of antibiotic courses (i.e. number of antibiotic prescriptions) one year prior to baseline/screening, and during each window period (Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months)|One year prior to baseline to 24 months post-baseline|Participants with data available during each window period||Antibiotic courses||Standard Deviation|Mean
720623|NCT00313144|Secondary|Healthcare Resource Utilization (HCRU) 'Number of Participants Taking Antibiotics'|Number of participants taking antibiotics one year prior to baseline/screening, and during each window period (Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months)|One year prior to baseline to 24 months post-baseline|Participants with data available during each window period||Participants|||Number
720624|NCT00313144|Secondary|Healthcare Resource Utilization (HCRU) 'Mean Length of Stay (LOS) in Hospital'|Mean LOS during each window period (Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months)|Baseline to 24 months|Participants with data available during each window period||Days||Standard Deviation|Mean
720625|NCT00313144|Secondary|Healthcare Resource Utilization (HCRU) 'Frequency of Hospitalizations'|Number of participants with indicated number of hospitalizations during each window period (Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months)|Baseline to 24 Months|Participants with data available during each window period||Participants|||Number
720626|NCT00313144|Secondary|Healthcare Resource Utilization (HCRU) 'Mean Number of Emergency Room (ER) Visits'|Mean number of ER visits one year prior to baseline/screening, and during each window period (Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months)|One year prior to baseline to 24 months post-baseline|Participants with data available during each window period||ER visits per time period||Standard Deviation|Mean
720627|NCT00313144|Secondary|Healthcare Resource Utilization (HCRU) 'Frequency of Emergency Room (ER) Visits'|Number of participants with indicated number of ER visits (0, 1, 2, 3, ≥4 ER visits per participant) during each window period (Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months)|Baseline to 24 Months|Participants with data available during each window period||Participants|||Number
720628|NCT00313144|Primary|HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months|SF-36 Scores- baseline thru 24 months, where data was available. Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The Data transformation process was based on: Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000.|Baseline to 24 months|Participants with baseline and participating during the period from baseline to ≤24 months data for HRQoL||Scores on a scale||Standard Deviation|Mean
720629|NCT00313144|Primary|HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, and >12 Months to ≤18 Months|SF-36 Scores- baseline thru 12 months, where data was available. Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The Data transformation process was based on: Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000.|Baseline to 12 months|Participants with baseline and participating during the period from baseline to ≤18 months data for HRQoL||Scores on a scale||Standard Deviation|Mean
720630|NCT00313144|Primary|HRQoL For: PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS: Baseline, Baseline to ≤6 Months, and >6 Months to ≤12 Months|SF-36 Scores- baseline thru 12 months, where data was available. Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The Data transformation process was based on: Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000.|Baseline to 12 months|Participants with baseline and participating during the period from baseline to ≤12 months data for HRQoL||Scores on a scale||Standard Deviation|Mean
720631|NCT00313144|Primary|HRQoL 'Mental Component Score (MCS)' From Baseline to ≤6 Months|SF-36 scores for baseline (screening) versus the period from baseline to ≤6 Months. The MCS is a summary scale of the dimensions vitality, social functioning, role emotional, and mental health Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores.|Screening to ≤ 6 Months|Participants with baseline and participating during the period from baseline to ≤6 months data for HRQoL||Scores on a scale||Standard Deviation|Mean
720775|NCT00303186|Secondary|Patient Global Assessment (PtGA) of Disease Activity Score|Measured using a 100 millimeter (mm) VAS ranging from 0 mm = very good to 100 mm = very bad.|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.||mm||Standard Deviation|Mean
720632|NCT00313144|Primary|HRQoL 'Physical Component Score (PCS)' From Baseline to ≤6 Months|SF-36 scores for baseline (screening) versus the period from baseline to ≤6 Months. The PCS is a summary scale of the dimensions physical functioning, role physical, bodily pain, and general health. The component score is normalized to a standard population. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores.|Screening to ≤ 6 Months|Participants with baseline and participating during the period from baseline to ≤6 months data for HRQoL||Scores on a scale||Standard Deviation|Mean
720633|NCT00313144|Primary|HRQoL 'Mental Health (MH)' From Baseline to ≤6 Months|Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The data transformation process was based on Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000.|Screening to ≤ 6 Months|Participants with baseline and participating during the period from baseline to ≤6 months data for HRQoL||Scores on a scale||Standard Deviation|Mean
720634|NCT00313144|Primary|HRQoL 'Role Limitation Due to Emotional Problems (RE)' From Baseline to ≤6 Months|Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The data transformation process was based on Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000.|Screening to ≤ 6 Months|Participants with baseline and participating during the period from baseline to ≤6 months data for HRQoL||Scores on a scale||Standard Deviation|Mean
720635|NCT00313144|Primary|HRQoL 'Social Functioning (SF)' From Baseline to ≤6 Months|Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The data transformation process was based on Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000.|Screening to ≤ 6 Months|Participants with baseline and participating during the period from baseline to ≤6 months data for HRQoL||Scores on a scale||Standard Deviation|Mean
720636|NCT00313144|Primary|HRQoL 'Vitality (VT)' From Baseline to ≤6 Months|Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The data transformation process was based on Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000.|Screening to ≤ 6 Months|Participants with baseline and participating during the period from baseline to ≤6 months data for HRQoL||Scores on a scale||Standard Deviation|Mean
720637|NCT00313144|Primary|HRQoL 'General Health (GH)' From Baseline to ≤6 Months|Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The data transformation process was based on Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000.|Screening to ≤ 6 Months|Participants with baseline and participating during the period from baseline to ≤6 months data for HRQoL||Scores on a scale||Standard Deviation|Mean
720638|NCT00313144|Primary|HRQoL 'Bodily Pain (BP)' From Baseline to ≤6 Months|Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The data transformation process was based on Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000.|Screening to ≤ 6 Months|Participants with baseline and participating during the period from baseline to ≤6 months data for HRQoL||Scores on a scale||Standard Deviation|Mean
720639|NCT00313144|Primary|HRQoL 'Role Limitation Due to Physical Health (RP)' From Baseline to ≤6 Months|Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The data transformation process was based on Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000.|Screening to ≤ 6 Months|Participants with baseline and participating during the period from baseline to ≤6 months data for HRQoL||Scores on a scale||Standard Deviation|Mean
720640|NCT00313144|Primary|HRQoL 'Physical Functioning (PF)' From Baseline to ≤6 Months|Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The data transformation process was based on: Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000.|Screening to ≤ 6 Months|Participants with baseline and participating during the period from baseline to ≤6 months data for HRQoL||Scores on a scale||Standard Deviation|Mean
720641|NCT00313170|Secondary|Pharmacokinetic Parameter: Mean Volume of Distribution at Steady State, a Measure of the Apparent Volume in the Body Into Which Fulvestrant Distributes|The measure of dispersion for volume of distribution is based on the inter-individual variance estimated for the apparent volume of plasma into which Fulvestrant distributes|Baseline to 12 weeks|||litres per hour||Standard Deviation|Mean
720888|NCT00303823|Primary|Progression - Persistent Oncogenic HPV Positivity, With Evidence of Progression to Worsening Cervical Intraepithelial Neoplasia or Invasive Cancer||4 months|||participants|||Number
720643|NCT00313170|Secondary|Clinical Benefit Rate (CBR)|A Clinical Benefit (CB) responder is defined as a patient having a best overall response of CR, PR or SD, provided that the SD was present at least 154 days from randomisation (ie. SD>=24 weeks - with the 2 week RECIST assessment time window allowed). The Clinical Benefit Rate is the percentage of patients with CB.|Each patient was assessed for Clinical Benefit from the sequence of RECIST (Response Evaluation Criteria in Solid Tumours) scan data up to the data cut-off, 13th June 2008. RECIST scans were performed every 12 weeks (+/- 2 weeks) from randomisation.|||Percentage of patients|||Number
720644|NCT00313170|Secondary|Duration of Response (DoR)|Time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who achieved a confirmed Complete Response (CR) or confirmed Partial Response (PR)|RECIST tumour assessments were carried out every 12 weeks (+/- 2 weeks) from randomisation until data cut-off on 13th June 2008||||||
720645|NCT00313170|Secondary|Time to Progression (TTP)|Median time (in days) from randomisation until objective disease progression or death (in the absence of objective progression) using the Kaplan-Meier method|RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation until data cut off on 13th June 2008|||Days||Full Range|Median
720646|NCT00313170|Primary|Objective Response (OR)|Number of participants who were objective responders over the number of participants evaluable for response x100. An objective responder = a patient whose best response is either CR (disappearance of all lesions) or PR (>= 30% shrinkage in the sum of the longest diameters of the measurable lesions + no new lesions + no progression of non-measurable lesions)|RECIST scans were performed every 12 weeks (+/- 2 weeks) from randomisation to until data cut off on 13th June 2008|||Percentage of patients|||Number
720647|NCT00313209|Secondary|Shortness of Breath Questionnaire (SOBQ) Total Score|"Mean change from baseline during the treatment period in SOBQ. This is a 24-item measure that assesses self-reported shortness of breath while performing a variety of activities of daily living. The questions were administered at visits V0, V2, V3, V4, V5, V6 and Vend to assess the perceived shortness of breath of the patient. For each activity listed in the questionnaire the patient should rate his/her breathlessness on a scale between zero and five, where zero is not at all breathless and five is maximally breathless or too breathless to do the activity."|Change from baseline over 24 weeks of treatment|ITT analysis. Number of participants analyzed = number of participants with data available.||scores on a scale||Standard Error|Least Squares Mean
720648|NCT00313209|Secondary|Transition Dyspnea Index (TDI) Focal Score|The TDI is a recognized questionnaire to measure dyspnea in an out patient COPD population. At baseline, 3 components of dyspnea, each graded with 4 questions, were asked: - Functional Impairment - Magnitude of Task - Magnitude of Effort At each of the post-randomization visits questions from the TDI were asked related to 3 components: Change in - Functional Impairment - Magnitude of Task - Magnitude of Effort Each question in the TDI is graded from –3 (major deterioration) to +3 (major improvement). This results in a TDI Focal Score ranging from –9 to +9.|Change from baseline over 24 weeks of treatment|ITT analysis. Number of participants analyzed = number of participants with data available.||scores on a scale||Standard Error|Least Squares Mean
720649|NCT00313209|Secondary|COPD Exacerbation Rate (Mild, Moderate or Severe)|Mean rate of COPD exacerbations requiring rescue medication of 3 or more puffs/day on at least 2 consecutive days (=mild COPD exacerbations), or requiring oral or parenteral glucocorticosteroids (=moderate COPD exacerbations), or requiring hospitalization, or leading to death (=severe COPD exacerbations), per patient per year. A COPD exacerbation is an event in the natural course of the disease characterized by a change in the patient's baseline dyspnea, cough and/or sputum beyond day-to-day variability sufficient to warrant a change in management [ATS / ERS 2005].|24 weeks treatment period|ITT analysis||exacerbations per patient per year||95% Confidence Interval|Mean
720650|NCT00313209|Secondary|Post-bronchodilator FEV1|Mean change from baseline during the treatment period in post-bronchodilator FEV1 [L]|Change from baseline over 24 weeks of treatment|ITT analysis. Number of participants analyzed = number of participants with data available.||mL||Standard Error|Least Squares Mean
720651|NCT00313209|Primary|Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1)|Mean change from baseline during the treatment period in pre-bronchodilator FEV1 [L]|Change from baseline over 24 weeks of treatment|ITT (Intention to Treat) analysis. Number of participants analyzed = number of participants with data available.||mL||Standard Error|Least Squares Mean
720652|NCT00313300|Secondary|Event Rate of Confirmed Adjudicated Major Bleeding During the Phase B Adjusted Treatment Period - Treated Participants Randomized in Phase B|Bleeding was assessed using the ISTH guidelines. Events were adjudicated by the CEC. Event rate was number of participants with events divided by the number of participants treated (%).|From first dose (Day 1) to last dose, plus 2 days (plus 30 days for SAEs), up to high dose termination, 1 October 2007|Participants concomitantly randomized in Phase B who received at least one dose of placebo or apixaban were summarized.||percentage of participants||95% Confidence Interval|Number
720653|NCT00313300|Secondary|Number of Participants With Composite of Adjudicated Cardiovascular Death, Non-Fatal Myocardial Infarction, Severe Recurrent Ischemia, Non-Hemorrhagic Stroke During the Phase B Adjusted Intended Treatment Period - Participants Randomized in Phase B|Phase B Adjusted Intended Treatment Period=day of randomization and ends on 1-Oct-2007. The analyses of Phase B data across all doses of apixaban are secondary due to the premature termination of the apixaban high dose groups and the lower duration of exposure.|Day of randomization up to high dose termination, 1-Oct-2007|Participants who were concomitantly randomized in Phase B were summarized.||participants|||Number
720654|NCT00313300|Secondary|Event Rate for Adjudicated All Bleeding Events During the Phase B Adjusted Treatment Period - Treated Participants Randomized in Phase B|Bleeding was assessed using the ISTH guidelines. Events were adjudicated by the CEC. Event rate was number of participants with events divided by the number of participants treated (%). All bleeding events included major bleeding, clinically relevant non-major bleeding and minor bleeding. Phase B Adjusted Treatment Period=safety events occurring in the period from first dose through 2 days (or through 30 days for SAE tabulations) after the earliest of last dose date or 1-Oct-2007 (termination date for the 10 mg BID group).|From first dose (Day 1) to last dose, plus 2 days (plus 30 days for SAEs), up to high dose termination, 1 October 2007|Participants concomitantly randomized in Phase B who received at least one dose of placebo or apixaban were summarized.||percentage of participants||95% Confidence Interval|Number
720889|NCT00303823|Primary|No Response - Persistent Oncogenic HPV Positivity, With or Without Evidence of Low Grade Cervical Intraepithelial Neoplasia||4 months|||participants|||Number
720655|NCT00313300|Secondary|Event Rate of Composite of Adjudicated Major Bleeding and Clinically Relevant Non-Major Bleeding During the Phase B Adjusted Treatment Period- Treated Participants Randomized in Phase B|Bleeding was assessed using ISTH guidelines. Events were adjudicated by the CEC. Event rate was number of participants with events divided by the number of participants treated, measured as a percentage (%). The analyses of Phase B data across all doses of apixaban are secondary because of the premature termination of the apixaban high-dose groups and the lower duration of exposure. Phase B Adjusted Treatment Period=safety events occurring in the period from first dose through 2 days (or through 30 days for SAE tabulations) after the earliest of last dose date or 1-Oct-2007 (termination date for the 10 mg BID group).|From first dose (Day 1) to last dose, plus 2 days (plus 30 days for SAEs), up to high dose termination, 1 October 2007|Participants randomized in Phase B only who received at least one dose of placebo or apixaban were summarized.||percentage of participants||95% Confidence Interval|Number
720656|NCT00313300|Secondary|Number of Participants With Composite of Adjudicated All-Cause Death, Non-Fatal Myocardial Infarction, Severe Recurrent Ischemia, Non-Hemorrhagic Stroke During the Phase B Adjusted Intended Treatment Period - Participants Randomized in Phase B|Phase B Adjusted Intended Treatment Period=day of randomization and ends on termination date of high dose apixaban, 1-Oct-2007. The analyses of Phase B data across all doses of apixaban are secondary due to the premature termination of the apixaban high dose groups and the lower duration of exposure.|Day of randomization and ends on high dose termination date, 1-Oct-2007|Participants who were concomitantly randomized in Phase B only were summarized (start of Phase B, March 2007, to termination of high doses in Phase B, October 2007) .||participants|||Number
720657|NCT00313300|Secondary|Event Rate of Confirmed Adjudicated Major Bleeding During the Treatment Period- Treated Participants With Placebo or Apixaban Low Doses|Bleeding was assessed using the ISTH guidelines. Events were adjudicated by the Clinical Events Committee. Event rate was number of participants with events divided by the number of participants treated, measured as a percentage (%).|from first dose (Day 1) to last dose plus 2 days, up to Year 2 of the Study|Participants who received at least one dose of placebo or low dose apixaban were analyzed.||percentage of participants||95% Confidence Interval|Number
720658|NCT00313300|Secondary|Number of Participants With a Composite of Adjudicated All-Cause Death, Non-Fatal Myocardial Infarction, Severe Recurrent Ischemia, and Non-Hemorrhagic Stroke During the Intended Treatment Period - Randomized Participants|Events were adjudicated by the Clinical Events Committee (CEC). Event rate was number of participants with events divided by the number of participants treated (%). Intended Treatment Period refers to the period starting on the day of randomization and ending 182 days after the day of randomization (for a total period duration of 183 days). Data in this outcome are combined across Phase A and Phase B|Day of randomization to 182 days after day of randomization (183 days)|Randomized participants were summarized.||participants|||Number
720659|NCT00313300|Secondary|Event Rate for Adjudicated All Bleeding Events During the Treatment Period - Treated Participants With Placebo or Apixaban Low Doses|Bleeding was assessed using the International Society on Thrombosis and Hemostasis (ISTH) guidelines. Events were adjudicated by the Clinical Events Committee (CEC). Event rate was number of participants with events divided by the number of participants treated (%). All bleeding events includes major bleeding, clinically relevant non-major bleeding and minor bleeding. Treatment Period refers to the period from first dose through 2 days, or through 30 days for Serious Adverse Event (SAE) tabulations, after discontinuation of study drug. Data in this outcome are combined across Phase A and Phase B.|first dose (Day 1) to last dose plus 2 days (or for SAEs, plus 30 days), up to Year 2 of the Study|Participants who received at least one dose of placebo or low dose apixaban are summarized. The analyses reported are based on data for the placebo and 2 apixaban low-dose groups (2.5 mg BID and 10 mg QD) combined across Phase A and Phase B.||percentage of participants||95% Confidence Interval|Number
720660|NCT00313300|Secondary|Number of Participants With a Composite of Adjudicated Cardiovascular Death, Non-Fatal Myocardial Infarction, Severe Recurrent Ischemia and Non-Hemorrhagic Stroke During the Intended Treatment Period - Randomized Participants|Events were adjudicated by the Clinical Events Committee (CEC). Intended Treatment Period refers to the period starting on the day of randomization and ending 182 days after the day of randomization (for a total period duration of 183 days). Data in this outcome are combined across Phase A and Phase B.|Randomization to 182 days after randomization (183 days)|Participants who randomized to placebo or low dose apixaban are summarized. Due to the premature termination of the 2 apixaban high-dose groups (10 mg BID and 20 mg QD) in Phase B, the analyses reported are based on data for the placebo and 2 apixaban low-dose groups (2.5 mg BID and 10 mg QD) combined across Phase A and Phase B.||participants|||Number
720661|NCT00313300|Primary|Event Rate of Composite of Adjudicated Major Bleeding and Clinically Relevant Non-Major Bleeding During the Treatment Period- Treated Participants With Placebo or Apixaban Low Doses|Bleeding was assessed using the International Society on Thrombosis and Hemostasis (ISTH) guidelines. Events were adjudicated by the Clinical Events Committee (CEC). Event rate was number of participants with events divided by the number of participants treated, measured as a percentage (%). The primary outcome is based on data for the placebo and 2 apixaban low-dose groups (2.5 mg BID and 10 mg QD) combined across Phase A and Phase B. The analyses of Phase B data across all doses of apixaban are secondary because of the premature termination of the apixaban high-dose groups (10mg BID, 20mg QD) and the resulting lower duration of exposure for these groups.|From first dose of study drug (Day 1) to last dose plus 2 days, up to Year 2 of the Study|Participants who received at least one dose of placebo or low dose apixaban. Due to the premature termination of the 2 apixaban high-dose groups (10 mg BID and 20 mg QD) in Phase B, the primary analyses reported are based on data for the placebo and 2 apixaban low-dose groups (2.5 mg BID and 10 mg QD) combined across Phase A and Phase B.||percentage of participants||95% Confidence Interval|Number
720662|NCT00313313|Secondary|Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24|Mean change from baseline for 0 to 180 minutes PPG AUC at Week 24, adjusted for baseline values.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.||mg*min/dL||Standard Error|Mean
720890|NCT00303823|Primary|Partial Response - Clearance of Oncogenic HPV With Evidence of Low Grade Cervical Intraepithelial Neoplasia||4 months|||participants|||Number
720663|NCT00313313|Secondary|Percentage of Participants Achieving A1C < 7% at Week 24|Percentage of participants achieving A1C < 7%, the American Diabetes Association's defined goal for glycemia, at each dose of saxagliptin plus glyburide versus placebo plus upward titrated glyburide at Week 24.|Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in the Week 24 LOCF analysis, participants must have had at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.||Percentage of participants|||Number
720664|NCT00313313|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Mean change from baseline in FPG at Week 24, adjusted for baseline value.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.||mg/dL||Standard Error|Mean
720665|NCT00313313|Primary|Change From Baseline in Hemoglobin A1c (A1C) at Week 24|Mean change from baseline in A1C at Week 24, adjusted for baseline value.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement. If participant received rescue medication, measurement must have been taken before rescue.||percent||Standard Error|Mean
720666|NCT00301756|Secondary|Stable Disease Rate, Defined as Neither Sufficient Shrinkage to Qualify for PR Nor Sufficient Increase to Qualify for PD, Taking as Reference the Smallest Sum LD Since the Treatment Started (Epithelial Ovarian Cancer Group)|Stable disease rate, defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. Summarized using summary statistics, such as the mean, median, counts and proportion. Assessed by RECIST criteria.|Up to 5 years|18 patients from Epithelian Ovarian Cancer patients were analyzed||participants|||Number
720667|NCT00301756|Secondary|Time to Disease Progression (Low Malignant Potential or Micropapillary / Borderline Ovarian Tumour Group)|Assessed by RECIST criteria. Summarized using summary statistics, such as the mean, median, counts and proportion.|Up to 5 years|||months||95% Confidence Interval|Median
720668|NCT00301756|Other Pre-specified|Relationship Between Clinical and Pharmacodynamic Effects of Belinostat in Patients With Platinum Resistant and Micropapillary/ Borderline Ovarian Tumors|Summarized using summary statistics, such as the mean, median, and range. Tested using one-sample t-tests or Wilcoxon rank sum tests. Logistic regression analysis will be used to test significance.|Up to 5 years||||||
720669|NCT00301756|Secondary|Safety and Tolerability of Belinostat in Patients With Platinum Resistant and Micropapillary/ Borderline Ovarian Tumors|Graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Tabulated using counts and proportions detailing frequently occurring, serious and related events of interest.|Up to 5 years||||||
720670|NCT00301756|Secondary|Overall Survival|Computed using the Kaplan-Meier method. Ninety-five percent confidence intervals will be constructed and selected results will be illustrated using figures and plots.|Up to 5 years||||||
720671|NCT00301756|Secondary|Progression-free Survival|Computed using the Kaplan-Meier method. Ninety-five percent confidence intervals will be constructed and selected results will be illustrated using figures and plots.|Duration of time from start of treatment to time of progression, assessed up to 5 years||||||
720672|NCT00301756|Secondary|Duration of Response|Summarized using summary statistics, such as the mean, median, counts and proportion. Ninety-five percent confidence intervals will be constructed and selected results will be illustrated using figures and plots.|From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 5 years|No participants had an objective response out of the 32 patients analyzed.|||||
720673|NCT00301756|Secondary|Stable Disease Rate, Defined as Neither Sufficient Shrinkage to Qualify for PR Nor Sufficient Increase to Qualify for PD, Taking as Reference the Smallest Sum LD Since the Treatment Started (Low Malignant Potential Group)|Stable disease rate, defined as neither sufficient shrinkage to qualify for Partial Response nor sufficient increase to qualify for Progressive disease, taking as reference the smallest sum LD since the treatment started. Summarized using summary statistics, such as the mean, median, counts and proportion. Assessed by RECIST criteria.|Up to 5 years|14 patients with Low Malignant Potential tumours or Micropapillary / borderline were analyzed||participants|||Number
720674|NCT00301756|Secondary|Time to Disease Progression (Epithelial Ovarian Cancer Group)|Assessed by RECIST criteria. Summarized using summary statistics, such as the mean, median, counts and proportion.|Up to 5 years|Eighteen patients with Epethelial Ovarian Cancer were analyzed||months||95% Confidence Interval|Median
720675|NCT00301756|Primary|Efficacy of Belinostat in Terms of Complete or Partial Response; Disappearance of All Target Lesions or at Least a 30% Decrease in the Sum of the Longest Diameter of Target Lesions, Taking as Reference the Baseline Sum LD|Efficacy of belinostat in terms of complete or partial response; disappearance of all target lesions or at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) or Rustin criteria.|Up to 5 years|||participants|||Number
720676|NCT00301808|Secondary|Toxicity||72 hours after 2nd and 3rd cycles: 30 days after completion of study treatment; Every 2 months thereafter; then once a year||||||
720677|NCT00301808|Secondary|Overall Survival||Date of registration to the date of death||||||
720678|NCT00301808|Secondary|Progression-free Survival||Approximately 3 weeks after the last cycle of cisplatin/pemetrexed or completion of radiation whichever is the later.||||||
720679|NCT00301808|Primary|Probability of Overall Survival at One Year|Using Kaplan-Meier product-limit analysis|at 1 year|||probability of overall survival||95% Confidence Interval|Number
720700|NCT00302003|Primary|Event Free Survival (EFS)|Survival is defined as the minimum time from study entry to a relapse of any kind, death from any cause, or occurrence of a second malignant neoplasm. Patients without report of such events where censored at last contact. This will be used to compute event free survival (EFS).|At 60 months|Eligible (n=278). Follow-up for censored patients (n=223) is 75 months (range: 4.7 to 108 months).||Probability of survival||95% Confidence Interval|Number
720680|NCT00301821|Secondary|Overall Response Rate (ORR)|Overall response rate will be estimated by the number of patients with objective status of partial response (PR), unconfirmed complete response (CRu), or complete response (CR) during the first 6 cycles of treatment divided by number of evaluable patients (met eligibility criteria, signed consent form, and started treatment). Response was assessed using International Workshop Response Criteria.38 Response is based on CT alone. Relapse or progression is defined as Enlarging liver/spleen, new sites, New or increased lymph nodes, New or Increased lymph node masses, bone marrow reappearance.|Baseline to first 6 cycles of treatment|Out of the 107 patients enrolled, Twenty-five patients were declared ineligible based on pathology review; 1 patient canceled before beginning treatment.||percentage of participants|||Number
720681|NCT00301821|Secondary|Progression-free Survival (PFS)|Percentage of participants Progression-free at different time points. Response was assessed using International Workshop Response Criteria.38 Response is based on CT alone. Relapse or progression is defined as Enlarging liver/spleen, new sites, New or increased lymph nodes, New or Increased lymph node masses, bone marrow reappearance.|the time from study entry to 36 months|Intent To Treat (All Patients)||percentage of participants|||Number
720682|NCT00301821|Secondary|Overall Survival|Percentage of participants alive at different time points|time from study entry to 36 months|Intent To Treat (All Patients)||percentage of Participants|||Number
720683|NCT00301821|Primary|Event-free Survival After 12 Months|The primary endpoint of the trial was the percentage of the eligible patients who were alive and event-free 12 months after enrollment to the study (EFS12).|From Baseline to 12 months|First 76 eligible participants were included in this analysis.||percentage of participants|||Number
720684|NCT00301834|Secondary|Disease-free Survival With Correction of Disease at One Year Post Transplantation|"Patients deemed alive and well at follow-up timepoint later than 1-year post-transplantation"|1 year post-transplantation|||participants|||Number
720685|NCT00301834|Secondary|Cytomegalovirus (CMV) Viral Infection and Disease Symptoms|polymerase chain reaction testing for presence of CMV weekly until at least day +100 then every 2 weeks until T-cell reconstitution as defined by cluster of differentiation 4 (CD4) > 200 cells/mm3. Median time to T-cell reconstitution was 6 months.|Up to one year post-transplant|4 participants were incapable of producing Ab or CMV testing result was indeterminate||participants|||Number
720686|NCT00301834|Secondary|Toxicity Grade ≥ 3 From Start of Conditioning Through the First Year Post Transplantation||1 year post-transplantation|||participants|||Number
720687|NCT00301834|Secondary|Treatment-related Mortality at 100 Days and 1 Year Post Transplantation||100 days and 1 year|||participants|||Number
720688|NCT00301834|Primary|Number of Participants Achieving Durable Engraftment (Presence of Donor Cells) at 6 Weeks Post Transplantation|Peripheral blood chimerism studies were performed by quantitative real time polymerase chain reaction (qPCR) evaluation of differential short tandem repeat DNA sequences|6 weeks post-transplant|Participants evaluable for engraftment 6 weeks post-transplant; 1 patient died of transplant-related hemorrhage prior to 6 weeks and was not evaluated for this outcome||participants|||Number
720689|NCT00301873|Secondary|Mean Change in Bone Mass Density (BMD)|Mean change in the combined t-score was measured by Dexa-scan. The patients bone density was determined by Dexa-scan at baseline, after 6 months Zometa and after 12 months of Zometa. The t-score, which is a comparison of a person’s bone density with that of a healthy 30-year old of the same sex, was generated by Dexa-scan for the spine and femur. A lower t-score implies a lower BMD. The combined t-score is the minimum of the t-score for the spine and that for the femur. BMD change from baseline at 6 and 12 months in the combined t-score was defined as the follow-up combined t-score minus the baseline combined t-score.|6 & 12 months|59 patients were accrued to the study; however follow-up at 6 months was available from 27 patients and at 12 months data was available from 19 patients.||T score units||Standard Deviation|Mean
720690|NCT00301873|Secondary|Skeletal-related Complications|Number of patients who experience skeletal-related complications during the administration of Zoledronate.|1 year|All patients.||participants|||Number
720691|NCT00301873|Primary|Percent of Patients With Change in Combined Bone Mass Density T-score <= -0.5.|Percent of patients who failed treatment as defined by a decrease of 0.5 or more from baseline in the combined T-score as measured by Dexa-scan. The patient's bone densitometry was determined by Dexa-scan at baseline, after 6 months of Zometa and after 1 year of Zometa. The t-score, which is a comparison of a person’s bone density with that of a healthy 30-year-old of the same sex, was generated by Dexa-scan for the spine and femur. The combined T-score is the minimum of the T-score for the spine and femur. A lower t-score implies a lower BMD.|6 and 12 months|59 patients were accrued; however only 27 had a follow-up assessment at 6 months and 19 at 12 months.||percentage of patients|||Number
720692|NCT00301964|Secondary|Initial Performance Status and Histological Grade||Up to 5 years||||||
720693|NCT00301964|Secondary|Overall Survival|Characterized graphically and using descriptive statistics.|From entry into the study to death or the date of last contact, assessed up to 5 years||||||
720694|NCT00301964|Secondary|Progression-free Survival|Characterized graphically and using descriptive statistics.|From study entry until disease progression, death or date of last contact, assessed up to 5 years||||||
720695|NCT00301964|Primary|Severity of Adverse Events as Assessed by CTCAE Version 3.0||Up to 5 years||||||
720696|NCT00301964|Primary|Frequency of Adverse Effects||Up to 5 years||||||
720697|NCT00301964|Primary|Best Tumor Response|"Response is measured according to Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.0):
Complete Response (CR) is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart.
Partial Response (PR) is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD.
Disease Progression is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.
Stable Disease is any condition not meeting the above criteria.
Indeterminate is defined as having no repeat tumor assessments following initiation of study therapy for reasons unrelated to symptoms or signs of disease."|study entry through completion|Total number eligible and evaluable participants||participants|||Number
720698|NCT00301964|Primary|Progression-free Survival Greater Than 6 Months|Disease Progression is at least a 20% increase in the sum of longest dimension (LD) of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.|6 months|Total number of eligible and evaluable participants||participants|||Number
720701|NCT00302003|Primary|Intensive Therapy Free Survival (ITFS).|Survival is defined as the minimum time from study entry to a relapse of higher risk at any time, any relapse following treatment with protocol mandated IFRT, death from any cause, or the occurrence of a second malignant neoplasm. This will be used to compute intensive therapy free survival (ITFS). Patients without report of such events where censored at last contact. This differs from traditional EFS in that relapse after AVPC* x3 therapy alone that does not place the patient in a higher risk category is not considered a treatment failure. In this definition, higher-risk relapse refers to relapse involving sites and extent of disease that place the patient in the current COG definition of intermediate or high-risk disease. If a patient with CR who experiences a LR relapse is not retreated with protocol-mandated chemotherapy and IFRT, subsequent disease relapses will nevertheless be counted in the analysis of the treatment strategy.|At 60 months|Eligible (n=278) and evaluable response and review of response, n=275. Follow-up for censored patients (n=245) is 76 months (range: 4.7 to 109 months).||Probability of survival||95% Confidence Interval|Number
720702|NCT00302003|Primary|Event Free Survival Without Receiving Radiation Therapy (EFSnoRT).|Survival is defined as the minimum time from study entry to requirement for additional chemotherapy and IFRT for retrieval, occurrence of a second malignant neoplasm, or death from any cause. Patients without report of such events where censored at last contact. Patients who achieve less than CR after 3 cycles of AV-PC will require IFRT and hence will satisfy this definition at the time of response evaluation. Patients who achieve a CR but who relapse will receive addition chemotherapy and IFRT or intense retrieval and hence will satisfy this definition at the time of the first relapse of Hodgkin disease. This endpoint will be used to compute event free survival without receiving radiation therapy (EFSnoRT).|At 60 months|Eligible (n=278) and evaluable response and review of response, n=275. Follow-up for censored patients (n=138) is 76 months (range: 1.8 to 108 months).||Probability of survival||95% Confidence Interval|Number
720703|NCT00302042|Secondary|Change in Dietary Composition||Baseline, 6 months||||||
720704|NCT00302042|Secondary|Rate of Community Program Participation||Baseline, 6 months||||||
720705|NCT00302042|Secondary|Physical Activity Level||Baseline, 6 months||||||
720706|NCT00302042|Primary|Change in Weight|6 months minus baseline|Baseline, 6 months|||percentage of change in weight||95% Confidence Interval|Mean
720707|NCT00302055|Secondary|Rate of Community Program Participation||6 months||||||
720708|NCT00302055|Secondary|Self Report Physical Activity||12 months||||||
720709|NCT00302055|Primary|Weight Loss|We analyzed repeated outcome measures using longitudinal linear regression with 3 observations per participant (baseline, 6 months, and 12 months)|12 months|||kilograms||95% Confidence Interval|Mean
720710|NCT00302068|Secondary|Interleuken 6 (IL-6)||Baseline, 16 weeks|All completed subjects plus 1 subject in the sertraline arm who did not complete but provided assessment data.||pg/ml||Standard Deviation|Mean
720711|NCT00302068|Secondary|Baroreflex Sensitivity (BRS)||Baseline, 16 weeks|Analysis based on 92 participants with valid baseline measurement.||msec/mmHg||Standard Deviation|Mean
720712|NCT00302068|Secondary|Platelet Factor 4||Baseline, 16 weeks|All completed subjects plus 1 subject in the sertraline arm who did not complete but provided assessment data.||IU/ml||Standard Deviation|Mean
720713|NCT00302068|Secondary|C-reactive Protein (CRP)||Baseline, 16 weeks|All completed subjects plus 1 subject in the sertraline arm who did not complete but provided assessment data.||ug/ml||Standard Deviation|Mean
720714|NCT00302068|Secondary|Percent Change in Flow Mediated Dilation (FMD)|Endothelial function assessed by flow mediated dilation (FMD). Brachial artery FMD was assessed following overnight fasting. Longitudinal B-mode ultrasound images of the brachial artery, 4-6 cm proximal to the antecubital crease, were obtained using an Aeuson (Mountain View, California) Aspen ultrasoundplatformwith an 11MHZ linear array transducer. lmages were obtained after 10 min of supine relaxation and during reactive hyperemia, induced following in ation of a forearm pneumatic occlusion cuff to supra-systolic pressure (~200 mmHg) for 5 minutes. FMD was defined as the maximum percent change inarterial diameter relative to restingbaseline from 10-120 sec post-deflation of the occlusion cuff.|Baseline, 16 weeks|All completed subjects plus 1 subject in the sertraline arm who did not complete but provided assessment data.||percentage change|||Number
720715|NCT00302068|Secondary|Heart Rate Variability (HRV)|HRV is the variation in the time interval between heart beats. ECG was recorded for 24 hours on a 3-channel digital compact ash Holter recorder. During the recording period, patients engaged in their normal patterns of activity. ECG data were downloaded and edited using the Pathfinder digital ambulatory ECG analyzer (DelMar Reynolds, lrvine, California) and HRV was estimated from the standard deviation of all normal R—R intervals (SDNN)|Baseline, 16 weeks|Analysis based on 93 participants with valid baseline measurements.||millisecond||Standard Deviation|Mean
720716|NCT00302068|Primary|Hamilton Depression Rating Scale|The Hamilton Depression Rating Scale ranges from 0 to 52, with lower scores reflecting lower levels of depression and higher scores greater severity of depression.|Measured at 16 weeks|All completed subjects plus 1 subject in the sertraline arm who did not complete but provided assessment data.||Raw changes in Ham-D scores||95% Confidence Interval|Mean
720717|NCT00302081|Secondary|Virologic Response Rates at the End of Therapy. Biochemical Responses as Determined by ALT and AST Levels at the End of Treatment and at the End of Follow up.|"Virologic response is defined as undetectable hepatitis C virus ribonucleic acid (HCV-RNA) in the serum. A blood test is used to measure the level of ALT and AST. ALT response was defined as ALT<40 IU/L (international units per liter).
This was not a prespecified key secondary outcome."|End of treatment: 24 weeks for arms [PEG2b 1.5/R (24 weeks)] and [PEG2b 1.0/R (24 weeks)]; 16 weeks for arm [PEG2b 1.5/R (16 weeks)]. Follow-up of 24 weeks for each arm.||||||
720718|NCT00302081|Primary|The Number of Participants Who Achieve a Sustained Virologic Response (SVR)|A sustained virologic response is defined as undetectable hepatitis C virus ribonucleic acid [HCV-RNA] 24 weeks post-treatment. Serum HCV-RNA is measured by HCV-PCR in local laboratories. HCV-RNA below the limit of detection is considered undetectable.|24-week treatment duration for Arms [Peg2b 1.5/R(24 weeks)] and [PEG2b 1.0/R(24 weeks]); 16-week treatment duration for Arm [PEG2b 1.5/R(16 weeks]. Follow-up of 24 weeks for each arm.|Intent-to-Treat (ITT) population||participants|||Number
720891|NCT00303823|Primary|Complete Response - Clearance of Oncogenic Human Papillomavirus (HPV) and Complete Colposcopic, Histologic and Cytologic Clearance of Disease||4 months|||participants|||Number
720719|NCT00302107|Primary|Structured Interview of Posttraumatic Stress Disorder (SIP)|Structured Interview of Posttraumatic Stress Disorder (SIP) is a 17-item clinician-administered scale for PTSD based on Diagnostic Statistical Manual-IV criteria. The SIP has excellent test-retest reliability (0.89; p=.00001), and internal consistency (Conbach α of 0.80). The SIP showed significant correlations with the DTS (r=0.67, p=.0001) and the Impact of Event Scale (r=0.49 p=.0001). Relative to the SCID diagnosis of PTSD, sensitivity, specificity, positive predictive value, negative predictive value, and efficiency values were 100% for all indices using a score of 20 on the SIP. Items are scored on a scale from 0-4 which are summed to yield a total score ranging from 0 to 68 (higher score means more symptomatic or worse outcome). A symptom is counted as positive if it is at least a 2 (moderate).|Primary outcome is measured at baseline and week 8 (primary endpoint) with primary outcome change scores calculated as week 8 minus baseline score.|Randomized, took at least one dose of study medication, and returned for at least one visit post-randomization||units on a scale||Standard Deviation|Mean
720720|NCT00302133|Secondary|% Subjects Abstinent|Proportion of subjects abstinent during the last 4 weeks of the trial|12 weeks|||percentage of participants|||Number
720721|NCT00302133|Primary|Mean Number of Standard Drinks Per Drinking Day During the Last 4 Weeks of the Trial||12 weeks|One subject in the naltrexone group was considered an outlier and excluded from the analysis as it will disproportionally skew the results of small sample size, and one subject in the placebo group was lost to follow-up immediately after group allocation and before any first post allocation assessment.||standard drinks/drinking day||Standard Deviation|Mean
720722|NCT00302159|Primary|Percentage of Participants With Overall Survival at 6, 12, and 24 Months|Percentage of participants who were alive at 6, 12, and 24 months.|6, 12, and 24 months|||percentage of participants|||Number
720723|NCT00302159|Primary|Median Overall Survival|Survival is the interval from the initiation of treatment on protocol to date of death.|up to 63.8 months|||months||95% Confidence Interval|Median
720724|NCT00302159|Primary|Number of Participants With Best Response|Best response recorded from the start of treatment until disease progression/recurrence. Complete response is complete resolution of all contrast enhancing tumor documented at initiation of treatment on protocol, with no appearance of new lesions. Partial response is a >50% reduction in the contrast enhancing tumor volume documented at the initiation of treatment on protocol. Minor response is a >25%, but <50% reduction in the contrast enhancing tumor volume documented at the initiation of treatment on protocol. Stable disease is a change in tumor size less than MR but not demonstrating progressive disease. Progressive disease is a >25% increase in contrast enhancing tumor volume documented at the initiation of treatment on protocol. Not evaluable means the participant cannot be evaluated (e.g., quality of scan).|up to 63.8 months|||participants|||Number
720725|NCT00302159|Primary|Percentage of Participants With Progression Free Survival at 6, 12, and 24 Months|Percentage of participants who were progression free by 6, 12, or 24 months. Progressive disease is a >25% increase in contrast enhancing tumor volume documented at the initiation of treatment on protocol.|6, 12, and 24 months|||percentage of participants|||Number
720726|NCT00302159|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|6 years, 7 months and 27 days|||participants|||Number
720727|NCT00302159|Primary|Median Progression Free Survival.|Progression free survival is the interval from initiation of treatment on protocol to symptomatic or radiographic progression. Progressive disease is a >25% increase in contrast enhancing tumor volume documented at the initiation of treatment on protocol.|up to 51 months|||months||95% Confidence Interval|Median
720728|NCT00302211|Primary|Number of Participants With Change From Baseline to Week 16 in 6-Minute Walk Test (MWT) in Double-blind, Modified Intent To Treat (MITT) Population|Comparing number of Modified Intent to Treat population in double-blind who improved in the 6-minute walk distance - from baseline distance between 100-450 meters. Any increase in walk distance was considered improvement from baseline. The 6-minute walks were measured in meters using a test administrator, a stop watch, and markers to identify the course.|Day 1 to Week 16|||participants|||Number
720729|NCT00302211|Other Pre-specified|Safety Objective|Assessment of the safety of the addition of iloprost inhlation solution in patients on oral sildenafil compared with placebo inhalation plus oral sildenafil. Safety variables observed were adverse events (AEs), laboratory data, and vitals.|Baseline up to 48 weeks||05/2010||||
720730|NCT00302211|Secondary|Assess the Efficacy of the Addition of Inhaled Iloprost in Patients With PAH Receiving a Stable Dose of Oral Sildenafil|The change in 6-minute walk distance (6-MWD) measured after inhalation, following 16 weeks of combination therapy with inhaled iloprost (administered 6 times or 4 times per day) inhaled iloprost plus sildenafil during the open-label extension phase.|Baseline Week 16 up to 48 weeks||05/2010||||
720731|NCT00302328|Secondary|Visual Field Defects|visual field defects measured on humphrey perimetry|6 months|from predetermined power analysis||participants|||Number
720732|NCT00302328|Secondary|Anatomic Success|closure of the macular hole evaluated on optical coherence tomography 3 (OCT3)|macular hole closure at 12 months|from initial power calculation of primary end point||participants|||Number
720733|NCT00302328|Primary|Visual Acuity (ETDRS Letters)|Visual acuity measured as the number of ETDRS letters at last follow-up|Visual acuity at 12 months|Decided from initial power calculation||Visual acuity in letters||Standard Error|Mean
720734|NCT00302458|Primary|Peak Plasma Concentration of d-Methylphenidate|Objective measure determined from blood samples, measured 4 hours after the dose|4 hours|All subjects received each combination of medications on a separate day (total= 5 days)||mg/L||Standard Deviation|Mean
720735|NCT00302718|Post-Hoc|Incidence of Hypotension Among All Patients With Hypertension|Patients had at least one primary care encounter during the interval assessed. We looked four months from the encounter for evidence of hypotension, either an outpatient systolic blood pressure (BP) < 90 mm Hg, an outpatient diagnosis of hypotension, or both. We combined the intervention arms (physician-level, practice group-level, and combined physician and practice group-level incentives) into one arm due to low frequency of events and low power.|February-May 2009|All patients with hypertension from the physicians' panel who had an outpatient encounter between February and May 2009. We used data from automated processing of structured fields from electronic health records to evaluate this measure.||percentage of all hypertensive patients|Participants||Number
720892|NCT00303862|Secondary|eNOS|Endothelial nitric oxide synthase gene (eNOS). Record genotype=number of minor alleles.|Baseline (prior to therapy)|Because trial was closed due to poor accrual, assays were not performed.|||||
720736|NCT00302718|Primary|Proportion of Physicians' Patients Prescribed Guideline-recommended Antihypertensive Medications|"This measure reports the unadjusted proportion of physicians' patients meeting the study outcome for the post-washout performance period. Data are based on review of the electronic health records for 40 patients with hypertension randomly selected from each physician's panel. We used the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7) to evaluate use of guideline-recommended antihypertensive medications. Assessing use of guideline-recommended medications included collecting information about the patient's compelling conditions (e.g., diabetes mellitus) as well as allergies and refusals to antihypertensive medications."|After the washout period (May-August 2011)|The number of physicians listed is those who participated in the post-washout performance period. The participant flow diagram describes the final number of physicians who received at least two instances of the intervention and were included in the repeated-measures longitudinal analysis.||percentage of physicians' patients|Participants||Number
720737|NCT00302718|Primary|Proportion of Physicians' Patients Prescribed Guideline-recommended Antihypertensive Medications|"This measure reports the unadjusted proportion of physicians' patients meeting the study outcome for the fifth and final intervention performance period. Data are based on review of the electronic health records for 40 patients with hypertension randomly selected from each physician's panel. We used the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7) to evaluate use of guideline-recommended antihypertensive medications. Assessing use of guideline-recommended medications included collecting information about the patient's compelling conditions (e.g., diabetes mellitus) as well as allergies and refusals to antihypertensive medications."|Final intervention period (April-July 2009)|The number of physicians listed is those who participated in the final intervention performance period. The participant flow diagram describes the final number of physicians who received at least two instances of the intervention and were included in the repeated-measures longitudinal analysis.||percentage of physicians' patients|Participants||Number
720738|NCT00302718|Primary|Proportion of Physicians' Patients Prescribed Guideline-recommended Antihypertensive Medications|"This measure reports the unadjusted proportion of physicians' patients meeting the study outcome for the first performance period (baseline). Data are based on review of the electronic health records for 40 patients with hypertension randomly selected from each physician's panel. We used the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7) to evaluate use of guideline-recommended antihypertensive medications. Assessing use of guideline-recommended medications included collecting information about the patient's compelling conditions (e.g., diabetes mellitus) as well as allergies and refusals to antihypertensive medications."|Baseline period (August-November 2007)|The number of physicians listed is those who participated in the baseline period. The participant flow diagram describes the final number of physicians who received at least two instances of the intervention and were included in the repeated-measures longitudinal analysis.||percentage of physicians' patients|Participants||Number
720739|NCT00302718|Primary|Proportion of Physicians' Patients With Blood Pressure Control or Appropriate Response to Uncontrolled Blood Pressure|"This measure reports the unadjusted proportion of physicians' patients meeting the study outcome for the post-washout performance period. Data are based on review of the electronic health records for 40 patients with hypertension randomly selected from each physician's panel. We used the guidelines from the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7) to determine if the physicians' patients achieved the recommended blood pressures thresholds and if providers appropriately responded to uncontrolled blood pressure. Appropriate responses included increasing the dosage of a guideline-recommended antihypertensive medication or recommending a lifestyle modification to patient with Stage 1 hypertension."|After the washout period (May-August 2011)|The number of physicians listed is those who participated in the post-washout performance period. The participant flow diagram describes the final number of physicians who received at least two instances of the intervention and were included in the repeated-measures longitudinal analysis.||percentage of physicians' patients|Participants||Number
720740|NCT00302718|Primary|Proportion of Physicians' Patients With Blood Pressure Control or Appropriate Response to Uncontrolled Blood Pressure|"This measure reports the unadjusted proportion of physicians' patients meeting the study outcome for the fifth and final intervention performance period. Data are based on review of the electronic health records for 40 patients with hypertension randomly selected from each physician's panel. We used the guidelines from the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7) to determine if the physicians' patients achieved the recommended blood pressures thresholds and if providers appropriately responded to uncontrolled blood pressure. Appropriate responses included increasing the dosage of a guideline-recommended antihypertensive medication or recommending a lifestyle modification to patient with Stage 1 hypertension."|Final intervention period (April-July 2009)|The number of physicians listed is those who participated in the final intervention period. The participant flow diagram describes the final number of physicians who received at least two instances of the intervention and were included in the repeated-measures longitudinal analysis.||percentage of physicians' patients|Participants||Number
720741|NCT00302718|Secondary|Colorectal Cancer (CRC) Screening, Low-density Lipoprotein (LDL) Cholesterol Levels, Hemoglobin (Hb) A1c Levels, and Beta Blocker Use||Secondary outcomes measured for baseline period, during the intervention period, and the post-washout period||||||
720751|NCT00302952|Primary|Change From Baseline in Albumin, Total Protein, Hemoglobin, and Mean Corpuscular Hemoglobin Concentration (MCHC) at Day 84|Blood samples were taken from participants at Baseline and Day 84. Participants with measurements for designated time points included in analysis. Change=Day 84 value minus Baseline value. A positive difference reflects an increased laboratory parameter value over time; a negative difference reflects a decreased laboratory parameter value over time. Normal laboratory values depend on a subject age, gender, and the specific laboratory methods that were used to determine the lab values. Reference: http://www.merckmanuals.com/professional/appendixes/normal_laboratory_values/blood_tests_normal_values.html|Baseline (Day 0), Day 84 (Wk 12)|Safety||g/dL||Standard Deviation|Mean
720893|NCT00303862|Secondary|KDR|Kinase insert domain-containing vascular endothelial growth factor receptor|Day 28 after initiation of therapy|Because trial was closed due to poor accrual, assays were not performed.|||||
720742|NCT00302718|Primary|Proportion of the Physicians' Patients With Blood Pressure Control or Appropriate Response to Uncontrolled Blood Pressure|"This measure reports the unadjusted proportion of physicians' patients meeting the study outcome for the first performance period (baseline). Data are based on review of the electronic health records for 40 patients with hypertension randomly selected from each physician's panel. We used the guidelines from the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7) to determine if the physicians' patients achieved the recommended blood pressures thresholds and if providers appropriately responded to uncontrolled blood pressure. Appropriate responses included increasing the dosage of a guideline-recommended antihypertensive medication or recommending a lifestyle modification to patient with Stage 1 hypertension."|Baseline period (August-November 2007)|The number of physicians listed is those who participated in the baseline period. The participant flow diagram describes the final number of physicians who received at least two instances of the intervention and were included in the repeated-measures longitudinal analysis.||percentage of physicians' patients|Participants||Number
720743|NCT00302848|Primary|Number of Participants With Venous Thromboembolism (VTE)||1.5 to 5 years|"The primary analysis compares the users of DRSP and LNG. Its results are presented below. The comparison of users of DRSP and OCs containing other progestins was only conducted for exploratory reasons. This secondary analysis showed similar results and is described in more detail in the publication of study results, see citations."||Participants|||Number
720744|NCT00302952|Primary|Change From Baseline in Mean Corpuscular Volume (MCV) at Day 84|Blood samples were taken from participants at Baseline and Day 84. Participants with measurements for designated time points included in analysis. Change=Day 84 value minus Baseline value. A positive difference reflects an increased laboratory parameter value over time; a negative difference reflects a decreased laboratory parameter value over time. Normal laboratory values depend on a subject age, gender, and the specific laboratory methods that were used to determine the lab values. Reference: http://www.merckmanuals.com/professional/appendixes/normal_laboratory_values/blood_tests_normal_values.html|Baseline (Day 0), Day 84 (Wk 12)|Safety||fL||Standard Deviation|Mean
720745|NCT00302952|Primary|Change From Baseline in Mean Corpuscular Hemoglobin (MCH) at Day 84|Blood samples were taken from participants at Baseline and Day 84. Participants with measurements for designated time points included in analysis. Change=Day 84 value minus Baseline value. A positive difference reflects an increased laboratory parameter value over time; a negative difference reflects a decreased laboratory parameter value over time. Normal laboratory values depend on a subject age, gender, and the specific laboratory methods that were used to determine the lab values. Reference: http://www.merckmanuals.com/professional/appendixes/normal_laboratory_values/blood_tests_normal_values.html|Baseline (Day 0), Day 84 (Wk 12)|Safety||pg||Standard Deviation|Mean
720746|NCT00302952|Primary|Change From Baseline in Red Cell Distribution Width (RDW) at Day 84|Blood samples were taken from participants at Baseline and Day 84. Participants with measurements for designated time points included in analysis. Change=Day 84 value minus Baseline value. A positive difference reflects an increased laboratory parameter value over time; a negative difference reflects a decreased laboratory parameter value over time. Normal laboratory values depend on a subject age, gender, and the specific laboratory methods that were used to determine the lab values. Reference: http://www.merckmanuals.com/professional/appendixes/normal_laboratory_values/blood_tests_normal_values.html|Baseline (Day 0), Day 84 (Wk 12)|Safety||% of mean corpuscle volume||Standard Deviation|Mean
720747|NCT00302952|Primary|Change From Baseline in Hematocrit (Hct) at Day 84|Blood samples were taken from participants at Baseline and Day 84. Participants with measurements for designated time points included in analysis. Change=Day 84 value minus Baseline value. A positive difference reflects an increased laboratory parameter value over time; a negative difference reflects a decreased laboratory parameter value over time. Normal laboratory values depend on a subject age, gender, and the specific laboratory methods that were used to determine the lab values. Reference: http://www.merckmanuals.com/professional/appendixes/normal_laboratory_values/blood_tests_normal_values.html|Baseline (Day 0), Day 84 (Wk 12)|Safety||% of packed red blood cells by volume||Standard Deviation|Mean
720748|NCT00302952|Primary|Change From Baseline in Counts: White Blood Cells (WBC), Neutrophils, Bands, Lymphocytes, Monocytes, Eosinophils, Basophils, Platelets, and Reticulocytes at Day 84|Blood samples were taken from participants at Baseline and Day 84. Participants with measurements for designated time points included in analysis. Change=Day 84 value minus Baseline value. A positive difference reflects an increased laboratory parameter value over time; a negative difference reflects a decreased laboratory parameter value over time. Normal laboratory values depend on a subject age, gender, and the specific laboratory methods that were used to determine the lab values. Reference: http://www.merckmanuals.com/professional/appendixes/normal_laboratory_values/blood_tests_normal_values.html|Baseline (Day 0), Day 84 (Wk 12)|Safety||10^3/uL||Standard Deviation|Mean
720749|NCT00302952|Primary|Change From Baseline in CPK at Day 84|Blood samples were taken from participants at Baseline and Day 84. Participants with measurements for designated time points included in analysis. Change=Day 84 value minus Baseline value. A positive difference reflects an increased laboratory parameter value over time; a negative difference reflects a decreased laboratory parameter value over time. Normal laboratory values depend on a subject age, gender, and the specific laboratory methods that were used to determine the lab values. Reference: http://www.merckmanuals.com/professional/appendixes/normal_laboratory_values/blood_tests_normal_values.html|Baseline (Day 0), Day 84 (Wk 12)|Safety||U/L||Standard Deviation|Mean
720750|NCT00302952|Primary|Change From Baseline in Potassium, Sodium, Chloride, and Total CO2 at Day 84|Blood samples were taken from participants at Baseline and Day 84. Participants with measurements for designated time points included in analysis. Change=Day 84 value minus Baseline value. A positive difference reflects an increased laboratory parameter value over time; a negative difference reflects a decreased laboratory parameter value over time. Normal laboratory values depend on a subject age, gender, and the specific laboratory methods that were used to determine the lab values. Reference: http://www.merckmanuals.com/professional/appendixes/normal_laboratory_values/blood_tests_normal_values.html|Baseline (Day 0), Day 84 (Wk 12)|Safety||mmol/L||Standard Deviation|Mean
720774|NCT00303186|Secondary|Physician Global Assessment (PGA) of Disease Activity|Physician Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity.|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.||mm||Standard Deviation|Mean
720752|NCT00302952|Primary|Change From Baseline in Total Bilirubin, Creatinine, BUN, Phosphorus, Calcium, and Glucose at Day 84|Blood samples were taken from participants at Baseline and Day 84. Participants with measurements for designated time points included in analysis. Change=Day 84 value minus Baseline value. A positive difference reflects an increased laboratory parameter value over time; a negative difference reflects a decreased laboratory parameter value over time. Normal laboratory values depend on a subject age, gender, and the specific laboratory methods that were used to determine the lab values. Reference: http://www.merckmanuals.com/professional/appendixes/normal_laboratory_values/blood_tests_normal_values.html|Baseline (Day 0), Day 84 (Wk 12)|Safety||mg/dL||Standard Deviation|Mean
720753|NCT00302952|Secondary|Adjusted Mean Change From Baseline in Serum Anti-cyclic Citrullinated Peptide (Anti-CCP) by ELISA (ELISA: Enzyme-linked Immunosorbent Assay)|Anti-CCP antibodies are autoantibodies frequently detected in the serum of individuals with rheumatoid arthritis. In this study, a positive value for anti-CCP was 8 IU/mL or greater; a negative value for anti-CCP was <8 IU/mL. Change= subtraction of Day 0 from Day 84 anti-CCP value. In general, high levels of the antibody indicate an aggressive rheumatoid arthritis and a higher risk of joint damage. Participants with measurements for designated time points included in analysis.|Baseline ( Day 0), Day 84 (Wk 12)|Intent-to-Treat with Available Data||IU/mL||Standard Error|Mean
720754|NCT00302952|Secondary|Adjusted Mean Change From Baseline in Serum IgM Rheumatoid Factor by ELISA (ELISA: Enzyme-linked Immunosorbent Assay)|Rheumatoid factor (RF) is an antibody often present in the blood of a person with rheumatoid arthritis. In this study, a positive value for RF was 0.5 IU/mL or greater; a negative value for RF was <0.5 IU/mL. Change= Day 84 value minus Baseline value. In general, presence of the antibody indicates aggressive rheumatoid arthritis and higher risk of joint damage. Participants with measurements for designated time points included in analysis.|Baseline (Day 0), Day 84 (Wk 12)|Intent-to-Treat with Available Data||IU/mL||Standard Error|Mean
720755|NCT00302952|Secondary|Percentage of Participants Meeting ACR20 Response Criteria at Day 84 (ACR: American College of Rheumatology)|Patients were ACR20 Responders if they had: at least 20% improvement in both tender joint count (28 examined) and swollen joint count (28 examined), and 20% improvement in at least three of the following 5 remaining ACR core measures: • Patient's pain assessment (Visual Analogue Scale (VAS) 100 mm) • Patient's global assessment of disease activity (VAS 100 mm) • Physician's global assessment of disease activity (VAS 100 mm) • Patient self-assessed disability (Health Assessment Questionnaire (HAQ)) score • Acute phase reactant C-reactive protein. Participants with measurements for designated time points were included in analysis.|Day 84 (Wk 12)|Intent-to-Treat with Available Data||Percentage of participants|||Number
720756|NCT00302952|Secondary|Adjusted Mean Change From Baseline in the Disease Activity Score Using C-reactive Protein (DAS28-CRP) on Day 84|The DAS28-CRP score is on a scale of 0 to 10 and indicates current activity of rheumatoid arthritis (>5.1=high disease activity; 3.2-<=5.1=moderate disease activity; <=3.2=low disease activity; <2.6=remission). The score uses a combination of four variables: 1) the number of tender joints (of the 28 that are measured); 2) the number of swollen joints (of the 28 that are measured); 3) serum C-reactive protein (CRP) lab value in mg/L , and 4) Patient Global Assessment of Disease Activity. Using a formula, the physician determines the score. Participants with measurements for designated time points included in analysis.|Baseline (Day 0) to Day 84 (Wk 12)|Intent-to-Treat with Available Data||Scores on a scale||Standard Error|Mean
720757|NCT00302952|Primary|Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST) at Day 84|Blood samples were taken from participants at Baseline and Day 84. Participants with measurements for designated time points included in analysis. Change=Day 84 value minus Baseline value. A positive difference reflects an increased laboratory parameter value over time; a negative difference reflects a decreased laboratory parameter value over time. Normal laboratory values depend on a subject age, gender, and the specific laboratory methods that were used to determine the lab values. Reference: http://www.merckmanuals.com/professional/appendixes/normal_laboratory_values/blood_tests_normal_values.html|Baseline (Day 0), Day 84 (Wk 12)|Safety||U/L||Standard Deviation|Mean
720758|NCT00302952|Primary|Adjusted Mean Change From Baseline in Log Transformed C - Reactive Protein (CRP) at Day 84|Blood draw for CRP, an acute phase reactant used to identify the presence of nonspecific inflammation. Change=Day 84 value minus Baseline value. Normal serum CRP reference range in this study is 0-4 mg/L (log transformed: -4.2 to 1.4). Participants with measurements for designated time points were included in analysis. An increased CRP level indicates the presence of inflammation. Reduced CRP levels could mean a decrease in inflammation.|Baseline (Day 0), Day 84 (Wk 12)|Intent-to-Treat with available data||mg/L||Standard Error|Mean
720759|NCT00303069|Secondary|Number of Participants With ≥2-fold Rise in Antibody Titer From Baseline at Day 7 Postvaccination||Baseline and Day 7 postvaccination|The population analyzed was the per-protocol population, excluding subjects identified as protocol violators. Subjects who were found to have deviated from the protocol procedures were evaluated to determine if they should be excluded from the per-protocol analyses. These evaluations were made prior to study unblinding on a case by case basis.||Participants|||Number
720760|NCT00303069|Primary|Number of Participants With ≥2-fold Rise in Antibody Titer From Baseline at Day 14 Postvaccination||Baseline and Day 14 postvaccination|The population analyzed was the per-protocol population, excluding subjects identified as protocol violators. Subjects who were found to have deviated from the protocol procedures were evaluated to determine if they should be excluded from the per-protocol analyses. These evaluations were made prior to study unblinding on a case by case basis.||Participants|||Number
720761|NCT00303069|Primary|Number of Vaccine-related Serious Adverse Experiences Following Vaccination|Participants with a serious vaccine-related adverse experiences (AE) (an AE which is assessed by an investigator/qualified physician as being related to study vaccine and results in death, persistent or significant disability/incapacity, prolongs an existing inpatient hospitalization, is life-threatening, a congenital anomaly/birth defect, a cancer, or an overdose).|Through Day 84 postvaccination|The population analyzed included all subjects who were randomized, vaccinated, and had safety follow-up.||Participants|||Number
720762|NCT00303108|Secondary|1-year Overall Survival|OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.|1 year|ITT population||probability of overall survival||95% Confidence Interval|Number
720763|NCT00303108|Secondary|Progression-free Survival (PFS)|"PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date.
Progression is defined as appearance of one or more new lesions. Unequivocal progression of existing non-target lesions. Although a clear progression of “non-target” lesions only is exceptional, in such circumstances, the opinion of the Treating Physician should prevail, and the progression status should be confirmed at a later time by the review panel."|30 months|ITT population||months||Full Range|Median
720764|NCT00303108|Secondary|Duration of Response|Duration from date of stating treatment to the date of first CR or PR.|From date of randomization until the date of first documented progression or date of intolerable toxicity, whichever came first, assessed up to 54 months.|Patients who achieved CR or PR.||months||Full Range|Median
720765|NCT00303108|Primary|Objective Response Rate (ORR)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective response (OR) = CR + PR.|From date of randomization until the date of first documented progression or date of intolerable toxicity, whichever came first, assessed up to 54 months.|Evaluable population||percentage of participants||95% Confidence Interval|Number
720766|NCT00303186|Secondary|36-Item Short-Form Health Survey (SF-36)|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and was reported as 2 summary scores; Physical Component Score and Mental Component Score. Total score range for the summary scores = 0-100 where higher scores represented higher level of functioning.|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.||units on a scale||Standard Deviation|Mean
720767|NCT00303186|Secondary|Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS)|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.||mm||Standard Deviation|Mean
720768|NCT00303186|Secondary|Euro Quality of Life (EQ-5D)- Health State Profile Utility Score|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. It assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.||units on a scale||Standard Deviation|Mean
720769|NCT00303186|Secondary|Health Assessment Questionnaire (HAQ)|HAQ: participant-reported assessment of ability to perform tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) hygiene; and 8) common activities over past week. Each item scored on 4-point Likert scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.||units on a scale||Standard Deviation|Mean
720770|NCT00303186|Secondary|Duration of Morning Stiffness|Duration of morning stiffness is defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (if none was present = 0; if morning stiffness was continuing, average of duration of stiffness over the past 3 days was reported; if stiffness persisted the entire day, 1440 minutes [24 hours*60 minutes] was recorded).|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|Data was not statistically analyzed because of insufficient data collected and small sample size achieved.||minutes||Standard Deviation|Mean
720771|NCT00303186|Secondary|C-reactive Protein (CRP)|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.||milligram/deciliter (mg/dL)||Standard Deviation|Mean
720772|NCT00303186|Secondary|Erythrocyte Sedimentation Rate (ESR)|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeter/hour (mm/hr). A higher rate is consistent with inflammation.|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.||mm/hr||Standard Deviation|Mean
720773|NCT00303186|Secondary|Visual Analogue Scale for Pain (VAS-pain)|100 mm line (VAS) marked by participant. Intensity of pain range (over past week): 0 = no pain to 100 = worst possible pain.|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.||mm||Standard Deviation|Mean
720894|NCT00303862|Secondary|Performance of DCE_MRI|Binary (yes/no) indicator of whether a dynamic contrast-enhanced MRI (DCE-MRI)was successfully performed.|One month after initiating therapy|Because trial was closed due to poor accrual, MRI data were not collected.|||||
720776|NCT00303186|Secondary|Radiographic Score Based on Wassenberg|Radiographic score based on wassenberg consisted of 2 sub-scores, proliferation score (PS) assessing bone proliferation and destruction score (DS) assessing joint surface destruction. Score range for PS and DS was 0 to 160 (where higher score represented higher bone proliferation) and 0 to 200 (where higher score represented higher destruction), respectively. Total score = sum of PS and DS (range 0 to 360); higher score represented worse state.|Baseline, Month 12, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.||units on a scale||Standard Deviation|Mean
720777|NCT00303186|Secondary|Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response|ACR70 response: >= 70% improvement in tender joint count; >= 70% improvement in swollen joint count; and >= 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.||percentage of participants|||Number
720778|NCT00303186|Secondary|Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response|ACR50 response: >= 50% improvement in tender joint count; >= 50% improvement in swollen joint count; and >= 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.||percentage of participants|||Number
720779|NCT00303186|Secondary|Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response|ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count; >= 20% improvement in swollen joint count; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.||percentage of participants|||Number
720780|NCT00303186|Secondary|Number of Swollen and Tender Joints|Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1. Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.||joints||Standard Deviation|Mean
720781|NCT00303186|Secondary|Maastricht Ankylosing Spondylitis Enthesis Score (MASES)|Assessment of enthesitis was performed in the following 7 domains: 1) 1st costochondral joint left and right, 2) 7th costochondral joint left and right, 3) posterior superior iliac spine left and right, 4) anterior superior iliac spine left and right, 5) iliac crest left and right, 6) 5th lumbar spinous process and 7) proximal insertion of Achilles tendon left and right. Each domain was graded for the presence (1) and absence (0) of tenderness yielding total MASES ranging from 0 (no tenderness) to 13 (worst possible score; severe tenderness).|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.||units on a scale||Standard Deviation|Mean
720782|NCT00303186|Secondary|Occiput-to-wall Distance|Occiput-to-wall distance: distance between the occiput (posterior or back portion of the head) and the wall when the participant stood with heels and shoulder against the wall and the back straight.|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.||cm||Standard Deviation|Mean
720783|NCT00303186|Secondary|Chest Expansion Measurement|Chest expansion, measured in cm, is defined as the difference in thoracic circumference during full expiration versus full inspiration, measured at the fourth intercostal space (nipple line).|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.||cm||Standard Deviation|Mean
720784|NCT00303186|Secondary|Modified Schober's Test|Measurement in centimeters (cm) of the distance between marks originally placed while the participant was standing erect 10 cm above and 5 cm below the midpoint of a line that joints the posterior superior iliac spines. Distance between marks was re-measured with participant maximally bend forward, knees fully extended, with spine in full flexion.|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.||cm||Standard Deviation|Mean
720785|NCT00303186|Secondary|Bath Ankylosing Spondylitis Radiology Index (BASRI)|BASRI- Radiographs of participants with AS were scored using the New York criteria for the sacroiliac joints on a scale of 2 to 4, the lumbar and cervical spine on a scale of 0 to 4 (0 = normal, 1 = suspicious, 2 = mild, 3 = moderate, 4 = severe). These 3 scores were added together to produce the BASRI-spine (BASRI-s) score (range 2 to 12). Similarly, hip joints were scored on a scale of 0 to 4 to give BASRI-hip (BASRI-h). Sum of BASRI-s and BASRI-h produced BASRI-total (BASRI-t) score; total range 2 to 16, higher score represented worse health state.|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|Data was not statistically analyzed because of insufficient data collected and small sample size achieved.||units on a scale||Standard Deviation|Mean
720786|NCT00303186|Secondary|Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)|BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a VAS of 0-10 (0=none and 10=very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The final BASDAI score averages the individual assessments for a final score range of 0-10.|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.||units on a scale||Standard Deviation|Mean
720787|NCT00303186|Secondary|Bath Ankylosing Spondylitis Functional Index (BASFI)|BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a Visual Analog Scale (VAS) of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a sum of the scores of the 10 questions. Total possible score range: 0-100, where higher score referred to higher impairment in the functional ability.|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.||units on a scale||Standard Deviation|Mean
720788|NCT00303186|Secondary|Psoriasis Area and Severity Index (PASI)|Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0= 0% to 6= 90–100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease.|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.||units on a scale||Standard Deviation|Mean
720789|NCT00303186|Secondary|Number of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC)|PsARC is comprised of 4 clinical improvement criteria: 1 unit (0-5 Likert scale) improvement on the Physician Global Assessment (PGA); 20% (0-100 scale) improvement on the participant assessments; and 30% reduction in the number of tender joints; and 30% reduction in the number of swollen joints. To achieve a clinical response, the participant must improve in 2 of the 4 PsARC criteria, 1 of which has to be the number of tender or swollen joints and none of the 4 scores could worsen.|Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.||participants|||Number
720790|NCT00303186|Secondary|Number of Participants With Assessment in Ankylosing Spondylitis (ASAS) 20 Response|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants. ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement from baseline and an absolute change >= 10 units on a 0-100 scale (0=no disease activity; 100=high disease activity) for >= 3 domains, and no worsening in remaining domain.|Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.||participants|||Number
720791|NCT00303186|Primary|Incremental Cost-effectiveness Ratio (ICER)|ICER: ratio of the incremental cost of treatment over the incremental effectiveness. Incremental cost = difference in cost between baseline and month 60. Effectiveness was defined as quality adjusted life year (QALY) gained, i.e. difference in Euro Quality of Life 5 Dimension (EQ-5D)- health state profile utility score between baseline and month 60. (EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Total score range -0.594 to 1.000; higher score indicates a better health state.)|Baseline up to Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.||ratio||95% Confidence Interval|Number
720792|NCT00303186|Primary|Mean Cost Per Participant Per Month at Month 60|Overall cost per participant per month was evaluated as part of health economics evaluation to quantify burden of Refractory PsA and its treatment, resources absorbed by the disease and its care into monetary terms. Overall cost was defined as sum of direct and indirect costs (productivity losses). Direct costs included cost of following cost variables: pharmacological treatment; hospitalizations; diagnostic examinations, laboratory analysis and specialist visits; transports.|Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.||Euro/participant-month||Standard Deviation|Mean
720793|NCT00303186|Primary|Mean Cost Per Participant Per Month at Month 12|Overall cost per participant per month was evaluated as part of health economics evaluation to quantify burden of Refractory PsA and its treatment, resources absorbed by the disease and its care into monetary terms. Overall cost was defined as sum of direct and indirect costs (productivity losses). Direct costs included cost of following cost variables: pharmacological treatment; hospitalizations; diagnostic examinations, laboratory analysis and specialist visits; transports.|Month 12|Intent-to-Treat (ITT) population included all participants who received at least 1 dose of the study medication.||Euro/participant-month||Standard Deviation|Mean
720794|NCT00303316|Primary|Geometric Mean Titers (GMTs) of Antibodies Before and After Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.|"Antibody titers determination:
Hepatitis B (Hep B) by enhanced chemiluminescence assay; Haemophilus influenzae type b (PRP), Tetanus, Pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by enzyme linked immunosorbent assay (ELISA); Diphtheria by neutralization test; Poliovirus types 1,2, and 3 by microneutralization assay."|Day 0 (pre-booster) and Day 30 post-booster|Geometric mean titers were assessed in all participants with endpoint data who received the booster vaccine (Intent-to-Treat Analysis Set for immunogenicity).||Titers||95% Confidence Interval|Geometric Mean
720895|NCT00303862|Primary|Objective Response|Objective radiologic response as measured by RECIST criteria. (30% or greater shrinkage in the sum of the longest diameters of target lesions)|Up to 6 weeks|||percentage of participants||95% Confidence Interval|Number
720795|NCT00303316|Secondary|Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™|"Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability.
Grade 3 was defined as: Pain, cries when injected limb is moved or movement of limb is reduced; Erythema and Swelling, ≥ 5 cm; Pyrexia, ≥ 39.6ºC; Vomiting, ≥ 6 episodes/24 hour or requiring parenteral hydration; Crying, > 3 hours; Somnolence, sleeping most of the time or difficulty to wake up; Anorexia, refuses ≥ 3 feeds/meals or refuses most feeds/meals; and Irritability, inconsolable."|Day 0 up to Day 30 post-booster vaccination|Solicited injection site and systemic reactions were assessed in the enrolled and vaccinated participants, Safety Analysis Set population.||Participants|||Number
720796|NCT00303316|Primary|Summary of Booster Response in Participants at 18 Months of Age Following Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.|Booster response were defined as titers ≥ 1.0 µg/mL for Haemophilus influenzae type b (PRP); ≥ 0.1 IU/mL for Diphtheria and Tetanus; ≥ 8 (1/dil) for Polio types 1, 2, and 3; and for Pertussis Toxoid (PT) and Filamentous Hemagglutinin (FHA) ≥ 4 EU/mL and a ≥ 4 fold increase from pre-booster to post-booster value.|Day 30 Post-booster Vaccination|Booster responses were assessed in all vaccinated participants with endpoint data following the booster vaccination (Intent-to-Treat population).||Participants|||Number
720797|NCT00303316|Primary|Summary of Antibody Persistence at 18 Months of Age in Participants That Received Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.|Antibody persistence (pre-booster) were defined as titers ≥ 10 mIU/mL for hepatitis B (Hep B;); ≥ 0.15 µg/mL for Haemophilus influenzae type b (PRP); ≥ 0.01 IU/mL for Diphtheria and Tetanus; ≥ 8 (1/dil) for polio types 1, 2, and 3; and ≥ 4 EU/mL for Pertussis Toxoid (PT) and Filamentous Hemagglutinin (FHA).|Day 0 (Before booster vaccination)|Antibody Persistence was assessed in all enrolled participants with pre-booster vaccination data (Intent-to-Treat population).||Participants|||Number
720798|NCT00303329|Secondary|The Absolute Change in Serum Ferritin (μg/L) Levels From Baseline to the End of the Study|Serum ferritin was monitored monthly and the dose of deferasirox was increased or decreased in steps of 5 to 10 mg/kg/day up to a maximum of 40 mg/kg/day if appropriate, every 3 months. If serum ferritin fell to 500 ng/mL or lower on two consecutive study visits, an interruption of treatment until serum ferritin was more than 500 ng/mL was considered.|Core study Baseline to end of extension study (up to 60 months)|The FAS comprised all participants who received at least one dose of deferasirox during either the core or extension studies.||μg/L||Standard Deviation|Mean
720799|NCT00303329|Secondary|The Absolute Change in Liver Iron Content (LIC) as Assessed by Superconducting Quantum Interference Device (SQUID) From Baseline to End of Study|Liver iron concentration was monitored at the end of the core study and then at the end of the extension study. High-risk participants, like participants with rare anemia, were excluded from any further potential liver biopsy, except if required and justified by the Investigator for the general care of the participant. Pediatric participants or participants with a medical contraindication to liver biopsy were allowed the use of SQUID in the extension study.|Core study Baseline to end of extension study (up to 60 months)|The FAS comprised all participants who received at least one dose of deferasirox during either the core or extension studies.||mg Fe/g dw||Standard Deviation|Mean
720800|NCT00303329|Secondary|The Change in Liver Iron Content (LIC) as Assessed by Liver Biopsy at Baseline to the End of the Study|Liver iron concentration was monitored at the start of the core study, the end of the core study, and then at the end of the extension study. High-risk participants, like participants with rare anemia, were excluded from any further potential liver biopsy, except if required and justified by the Investigator for the general care of the participant.|Core study Baseline to end of extension study (up to 60 months)|The full analysis Set (FAS) comprised all participants who received at least one dose of deferasirox during either the core or extension studies.||mg Fe/g dw||Standard Deviation|Mean
720801|NCT00303329|Primary|The Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) or Deaths|Safety was assessed using reports of adverse events of all participants in this study. Serious adverse events are those events that resulted in death, were life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.|Core study Baseline to the end of the study (up to 60 months)|The safety analysis set comprised all participants who received at least one dose of deferasirox during either the core or extension studies.||Participants|||Number
720802|NCT00303446|Secondary|International Index for Erectile Function (IIEF), Change From Baseline|Sexual function was rated using the International Index of Erectile Function (IIEF). The total IIEF score (5-75, worst-best) was reported as the percent maximum (0-100%).|0, 12, and 24 months|||percent of maximum score||Standard Deviation|Mean
720803|NCT00303446|Secondary|Medical Outcomes Study 36-item Short Form Version 2 (SF-36v2) Mental Component Summary, Percent Change From Baseline|Subjects completed the Medical Outcomes Study Short Form Version 2 (SF-36v2), in which they rated their mental quality of life over the preceding 4 weeks. Raw SF-36v2 scores were converted to norm-based scales and component summaries using the scoring code provided by QualityMetric (mean=50, standard deviation (SD)=10), and percent change in the norm-based scale was calculated.|0, 12, and 24 months|||percent change||Standard Deviation|Mean
720804|NCT00303446|Secondary|Medical Outcomes Study 36-item Short Form Version 2 (SF-36v2) Physical Component Summary, Change From Baseline|Subjects completed the Medical Outcomes Study Short Form Version 2 (SF-36v2), in which they rated their physical quality of life over the preceding 4 weeks. Raw SF-36v2 scores were converted to norm-based scales and component summaries using the scoring code provided by QualityMetric (mean=50, standard deviation (SD)=10).|0, 12, and 24 months|||percent change||Standard Deviation|Mean
720805|NCT00303446|Secondary|Activities of Daily Living, Change From Baseline|Subjects rated their daily activity with a modified 9-question Activities of Daily Living (ADL) questionnaire (0-4, fully impaired to normal).|0, 12, and 24 months|||units on a scale||Standard Deviation|Mean
720896|NCT00303901|Primary|Distant Failure Rate||at 3, 6, and 12 months|||% of participants with distant failure||95% Confidence Interval|Number
720897|NCT00303901|Secondary|Point and Exact Confidence Interval Estimates of Patients Who Undergo Multiple Cryotherapy Procedures||12 months after the last patient was enrolled||||||
720898|NCT00303901|Secondary|Correlate Procedural Parameters and Follow-up Imaging Parameters||at 3, 6, and 12 months||||||
720806|NCT00303446|Secondary|Motor Unit Nerve Estimation, Change From Baseline|Motor unit number estimation (MUNE) was done with a statistical MUNE program, on the abductor pollicis brevis. All subjects were evaluated on the right side unless severe atrophy produced very low compound muscle action potentials; in this case, the left side was investigated or the abductor digiti minimi was substituted. A decrease in MUNE indicates a loss of motor units.|0, 12, and 24 months|||motor unit number||Standard Deviation|Mean
720807|NCT00303446|Secondary|Peroneal Compound Muscle Action Potential, Change From Baseline|Nerve conduction studies were done on the peroneal nerve, and the compound muscle action potential amplitude was determined. Loss of amplitude indicates impairment of conduction.|0, 12, and 24 months|||mVolts||Standard Deviation|Mean
720808|NCT00303446|Secondary|Median Compound Muscle Action Potential, Change From Baseline|Nerve conduction studies were done on the median motor nerve, and the compound muscle action potential amplitude was determined. Loss of amplitude indicates impairment of conduction.|0, 12, and 24 months|||mVolts||Standard Deviation|Mean
720809|NCT00303446|Secondary|Sensory Nerve Action Potential Average, Change From Baseline|Nerve conduction studies were done on four sensory nerves (median, ulnar, radial, sural), and the amplitudes of the evoked responses were averaged. Loss of amplitude indicates impairment of conduction.|0, 12, and 24 months|||microVolts||Standard Deviation|Mean
720810|NCT00303446|Secondary|Bulbar Rating Scale, Change From Baseline|The Bulbar Rating Scale includes eight domains each rated on a 1-4 scale, abnormal to normal. The original 8-32 point scale was transformed to a 0-100% scale to represent the responses as percentages.|0, 12, and 24 months|||percentage of maximum score||Standard Deviation|Mean
720811|NCT00303446|Secondary|Swallow Score Average, Change From Baseline|Modified barium swallow studies were done at 0, 12, and 24 months. Twenty-five domains were assessed, and six were chosen for final analysis based on the abnormal findings in subjects evaluated at baseline: vallecular pooling and repeated-swallow, each assessed with thin liquids, purees, and solids (rated 1-4, abnormal to normal).|0, 12, and 24 months|||units on a scale||Standard Deviation|Mean
720812|NCT00303446|Secondary|Timed 2-minute Walk, Change From Baseline|The subjects did the 2-minute walk in a 50-foot (15.2-meter) corridor three times, and the average distance was calculated. The subjects were allowed to use an assistive device and rest between the trials.|0, 12, and 24 months|||meters||Standard Deviation|Mean
720813|NCT00303446|Secondary|Adult Myopathy Assessment Tool, Change From Baseline|The Adult Myopathy Assessment Tool rates physical function and muscle endurance, with higher scores indicating better performance; it includes 7 timed functional tasks and 6 endurance tasks (0=worst, 45=best).|0, 12, and 24 months|||units on a scale||Standard Deviation|Mean
720814|NCT00303446|Secondary|Manual Muscle Testing, Change From Baseline.|Manual muscle testing was performed using a modified Medical Research Council (MRC) scale (0=worst, 5=best); the average muscle score was based on 22 muscle groups.|0, 12, and 24 months|||MRC units on a scale||Standard Deviation|Mean
720815|NCT00303446|Secondary|Creatine Kinase, Change From Baseline|Serum creatine kinase was determined in venous blood samples analyzed at the Department of Laboratory Medicine of the NIH Clinical Center.|0, 12, and 24 months|||Units/liter||Standard Deviation|Mean
720816|NCT00303446|Primary|Muscle Strength Change From Baseline|Quantitative muscle assessment (QMA) was done with a fixed frame dynamometer, a strain gauge tensiometer, and a computer-aided acquisition system. Maximal voluntary isometric muscle contractions were measured twice, the average was calculated, and the results were summed over 22 muscle groups (11 on each side). The total force was scaled for body weight and expressed as percent change from baseline. Measurements were performed at 0, 12, and 24 months. The calculated percent changes at 12 and 24 months are shown.|0, 12, and 24 months|The participants analyzed were those who were available for analysis at 12 and 24 months.||percent change||Standard Deviation|Mean
720817|NCT00303459|Secondary|Patient Global Self Assessment (PGSA) Status at Week 16|The PGSA is a questionnaire that allows the patient to compare his/her PAH status in response to the question “How do you feel about your PAH today compared with your last visit?” asked by the investigator. Patients use a seven-point scale to respond: markedly better, moderately better, mildly better, no change, markedly worse, moderately worse, or mildly worse.|Week 16|All randomized set, patients who completed the assessment||participants|||Number
720818|NCT00303459|Secondary|Change From Baseline to Week 16 in the EuroQol 5 Dimensions (EQ-5D) Visual Analogue Scale Score|The EQ-5D questionnaire is a patient-reported outcome consisting of a 5 dimensional descriptive system and a visual analog scale (VAS) together with brief demographic questions. EQ-5D VAS asks respondents to rate their perception of their overall health on a vertical visual analogue scale with ‘best imaginable health state’ set at 100 and ‘worst imaginable health state’ set at 0.|Baseline to Week 16|All randomized set||units on a scale||Standard Deviation|Mean
720819|NCT00303459|Secondary|Change From Baseline to Week 16 in the EuroQol 5 Dimensions (EQ-5D) Questionnaire Calculated Score|The EQ-5D questionnaire is a patient-reported outcome consisting of a 5 dimensional descriptive system and a visual analog scale (VAS). The descriptive system asks respondents to describe their health status. Health is defined in 5 dimensions: (1) mobility, (2) self care, (3) usual activities, (4) pain or discomfort, and (5) anxiety or depression. Each dimension is divided into 3 levels, indicating (a) no problem, (b) some or moderate problems, or (c) extreme problems. Respondents record their problem(s) in each of the 5 dimensions. Combinations of these levels define a total of 243 health states. A health state defined by the descriptive system of EQ-5D can be described by a 5-digit number with full health is indicated by 11111 and poorest health state by 33333. The EQ-5D calculated score was derived by re-assigning local scores for answers to each question and combining these local scores into a global score with ranges from 0 (worst possible outcome) to 1 (best possible outcome).|From baseline to Week 16|All randomized set||units on a scale||Standard Deviation|Mean
720820|NCT00303459|Secondary|Change From Baseline to Week 16 in Borg Dyspnea Index|The Borg dyspnea index was evaluated immediately after the 6MWT to obtain a rating of dyspnea at the end of the exercise using a scale from 0 (‘Nothing at all’) to 10 (‘Very, very severe – maximal’).|Baseline to Week 16|All randomized set||units on a scale||Standard Deviation|Mean
720899|NCT00303901|Secondary|Rate of Complications and Adverse Reactions by Occurrences of Toxicities||at 3, 6, and 12 months||||||
720900|NCT00303901|Primary|Local Failure Rates by CT Scan||at 3, 6, and 12 months|||% of participants with local recurrence||95% Confidence Interval|Number
720821|NCT00303459|Secondary|Adjusted Percentage Ratio From Baseline in N-terminal Pro-B-type Natriuretic Peptide (NT-pro-BNP)|Blood sampling for the measurement of NT-pro-BNP was performed and the plasma concentrations of NT-pro-BNP were determined by a certified centralized laboratory.|Baseline to Month 20|All randomized patients with a baseline and at least one post-baseline value. Assessments considered are those where at least 60% of the patients have a post-baseline value||Adjusted percentage ratio from baseline||95% Confidence Interval|Geometric Mean
720822|NCT00303459|Secondary|Time to Death of All Causes From Baseline to End of Study|Kaplan-Meier estimate of percentage of participants without a mortality event.Time to death due to any cause.|Baseline to End of Study, approximately 86 months|All randomized set||percentage of participants-Kaplan Meier|||Number
720823|NCT00303459|Secondary|Number of Participants With Improved, No Change, or Worsened World Health Organisation Functional Class From Baseline to Week 16|Class I: no limitation of usual physical activity (PA) which does not increase dyspnea, fatigue, chest pain, or presyncope. Class II: mild limitation of PA. No discomfort at rest. Normal PA increases dyspnea, fatigue, chest pain, or presyncope. Class III: marked limitation of PA. No discomfort at rest. Less than ordinary activity increases dyspnea, fatigue, chest pain, or presyncope. Class IV: unable to perform any PA and who may have signs of right ventricular failure. Dyspnea and/or fatigue may be present at rest and symptoms are increased by almost any PA.|From baseline to Week 16|All randomized set||participants|||Number
720824|NCT00303459|Secondary|Change From Baseline to Week 16 in 6 Minute Walk Test (6MWT)|The 6MWT is a non-encouraged test, which measures the distance covered over a 6 minute walk; the patient is instructed to walk as far as possible in a 30 m long flat corridor, back and forth around two cones, with the permission to slow down, rest, or stop if needed. Areas were to be well ventilated with air temperature controlled between 20 °C and 23 °C (68 °F to 76 °F). The test was to be administered at the same time of day and by the same tester throughout the study. The tester measured the distance walked by non-encouraged patients during the timed 6 minute period.|From baseline to week 16|All randomized set||m||Standard Deviation|Mean
720825|NCT00303459|Secondary|Time to First Confirmed Death, Hospitalization for Worsening or Complication of PAH or Initiation of Intravenous Prostanoids, Atrial Septostomy, or Lung Transplantation|Kaplan-Meier estimate of percentage of participants without an event of death, hospitalization (for worsening or complication of PAH or initiation of intravenous prostanoids), atrial septostomy or lung transplantation. Time to first confirmed death, hospitalization (for worsening or complication of PAH or initiation of intravenous prostanoids), atrial septostomy or lung transplantation from baseline to end of study was confirmed by an independent Clinical Endpoint Committee.|Baseline to end of study, approximately 86 months|All randomized set||percentage of participants-Kaplan Meier|||Number
720826|NCT00303459|Primary|Time to First Confirmed Morbidity/Mortality Event up to the End of Study|"Kaplan-Meier estimate of percentage of participants without a morbidity/mortality event. A morbidity/mortality event is defined as the occurrence of a) death, b) hospitalization for worsening or complication of PAH or intravenous prostanoid initiation, c) atrial septostomy, d) lung transplantation, or e) worsening PAH, defined as moderately or markedly worsened PAH symptoms using a patient global self-assessment (PGSA) scale AND initiation of inhaled or subcutaneous prostanoids or the disease progression package (open-label bosentan). If a patient replied no change or mildly worse on the PGSA, a decrease in 6MWT of 20% versus last visit or 30% versus baseline is also required to confirm the event."|From baseline to end of study, approximately 86 months|All randomized set||percentage of participants-Kaplan Meier|||Number
720827|NCT00303472|Primary|Part B: Number of Participants With Adverse Events|The number of participants experiencing one or more adverse events during the treatment phase or extension phase of Part B.|Treatment period (8 weeks) plus treatment extension (1 year)|All participants who received at least one dose of study medication||Participants|||Number
720828|NCT00303472|Primary|Part A: Number of Participants With Adverse Events|The number of participants experiencing one or more adverse events during the treatment phase or extension phase of Part A.|Treatment period (4 weeks) plus treatment extension (1 year)|All participants who received at least one dose of study medication||Participants|||Number
720829|NCT00303472|Secondary|Part B: Week 7 Tmax|Time at which the maximum concentration of romiplostum was observed after subcutaneous administration during Week 7|Week 7|Safety Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim||Hours||Full Range|Median
720830|NCT00303472|Secondary|Part B: Week 1 Tmax|Time at which the maximum concentration of romiplostum was observed after subcutaneous administration during Week 1|Week 1|Safety Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim||Hours||Full Range|Median
720831|NCT00303472|Secondary|Part B: Week 7 AUC0-4|Area under the romiplostim concentration-time curve from time zero to the last time point with quantifiable concentration (AUC0-4) during Week 7.|Week 7|Safety Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim||hr*pg/mL||Standard Deviation|Mean
720832|NCT00303472|Secondary|Part B: Week 7 Ctrough|Measured romiplostim concentration at the end of the Week 7 dosing interval (Ctrough)|Week 7|Safety Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim||pg/mL||Standard Deviation|Mean
720833|NCT00303472|Secondary|Part B: Week 7 Cmax|Maximum observed serum concentration (Cmax) of romiplostim during Week 7.|Week 7|Safety Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim||pg/mL||Standard Deviation|Mean
720834|NCT00303472|Secondary|Part B: Week 1 AUC0-4|Area under the romiplostim concentration-time curve from time zero to the last time point with quantifiable concentration (AUC0-4) during Week 1|Week 1|Safety Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim||hr*pg/mL||Standard Deviation|Mean
720835|NCT00303472|Secondary|Part B: Week 1 Ctrough|Measured romiplostim concentration at the end of the week 1 dosing interval (Ctrough)|Week 1|Safety Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim||pg/mL||Standard Deviation|Mean
720836|NCT00303472|Secondary|Part B: Week 1 Cmax|Maximum observed serum concentration (Cmax) of romiplostim during Week 1|Week 1|Safety Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim||pg/mL||Standard Deviation|Mean
721050|NCT00318409|Primary|Acceptability: Adherence to Daily Bupropion and Placebo, as Determined by MEMS (Medication Event Monitoring System) Caps Openings|Proportion of days in which the MEMS cap device was opened during of the 12 weeks on study drug.|12 weeks|||percentage adherence by MEMS|||Number
720837|NCT00303472|Secondary|Part B: Duration of Platelet Response|Duration of platelet response per IWG criteria (absolute increase of ≥ 30 x 10^9/L with Baseline platelet count > 20 x 10^9/L, or with a Baseline ≤ 20 x 10^9/L increasing the platelet count to above 20 x 10^9/L and by at least 100% for 8 consecutive weeks).|Treatment Period (8 weeks) and extension period (52 weeks)|Subset of Efficacy Analysis Set, composed of all enrolled participants who received romiplostim and completed the treatment phase, who had a platelet response||Weeks||Inter-Quartile Range|Median
720838|NCT00303472|Secondary|Part B: Time to First Platelet Response|Participants achieving first platelet response according to IWG criteria, by study week. Platelet response was defined as an absolute increase of ≥ 30 x 10^9/L with Baseline platelet count > 20 x 10^9/L, or with a Baseline ≤ 20 x 10^9/L increasing the platelet count to above 20 x 10^9/L and by at least 100% for 8 consecutive weeks. Platelet counts obtained within 72 hours of platelet transfusion were not evaluable for platelet response.|Treatment Period (8 weeks) and extension period (52 weeks).|Efficacy Analysis Set, composed of all enrolled participants who received romiplostim and completed the treatment phase||Participants|||Number
720839|NCT00303472|Secondary|Part B: Peak Platelet Count|Peak platelet count (10^9/L) during the treatment period.|Treatment Period (8 weeks)|Efficacy Analysis Set, composed of all enrolled participants who received romiplostim and completed the treatment phase.||10^9/L||Inter-Quartile Range|Median
720840|NCT00303472|Secondary|Part B: Number of Participants With a Platelet Response Per IWG|The number of participants with a platelet response according to the modified International Working Group (IWG) criteria. Response was defined as an absolute increase of ≥ 30 x 10^9/L with Baseline platelet count > 20 x 10^9/L, or with a Baseline count ≤ 20 x 10^9/L, increasing to above 20 x 10^9/L and by at least 100% during the treatment or extension period and maintained for at least 8 consecutive weeks. Platelet transfusion was not considered a rescue medication but platelet counts ≤72 hours after platelet transfusion were excluded from the analysis.|Treatment period (8 weeks) and extension period (52 weeks).|Efficacy Analysis Set, composed of all enrolled participants who received romiplostim and completed the treatment phase||Participants|||Number
720841|NCT00303472|Secondary|Part A: Number of Participants With a Platelet Response Per IWG Criteria|The number of participants with a platelet response according to the modified International Working Group (IWG) criteria. Response was defined as an absolute increase of ≥ 30 x 10^9/L with Baseline platelet count > 20 x 10^9/L, or with a Baseline count ≤ 20 x 10^9/L, increasing to above 20 x 10^9/L and by at least 100% during the treatment or extension period and maintained for at least 8 consecutive weeks. Platelet transfusion was not considered a rescue medication but platelet counts ≤72 hours after platelet transfusion were excluded from the analysis.|Treatment period (4 weeks) and extension period (52 weeks).|Subset of Efficacy Analysis Set, composed of all enrolled participants who received romiplostim and completed the treatment phase, who entered the treatment extension.||Participants|||Number
720842|NCT00303472|Secondary|Part B: Number of Participants With a Complete or Major Platelet Response|Participants with a complete or major response during the treatment phase. A complete platelet response was defined as a platelet count ≥ 100 x 10^9/L during the treatment phase. A major platelet response was defined as an increase in absolute platelet count of ≥ 30 x 10^9/L for patients starting with > 20 x 10^9/L platelets, or an increase from ≤ 20 x 10^9/L to > 20 x 10^9/L and by at least 100%. Any participant receiving rescue medication was considered a non-responder. Platelet transfusions were considered rescue medication.|Treatment Period (8 weeks)|Efficacy Analysis Set, composed of all enrolled participants who received romiplostim and completed the treatment phase.||Participants|||Number
720843|NCT00303472|Secondary|Part A: Number of Participants With a Complete or Major Platelet Response|Participants with a complete or major response during the treatment phase. A complete platelet response was defined as a platelet count ≥ 100 x 10^9/L during the treatment phase. A major platelet response was defined as an increase in absolute platelet count of ≥ 30 x 10^9/L for patients starting with > 20 x 10^9/L platelets, or an increase from ≤ 20 x 10^9/L to > 20 x 10^9/L and by at least 100%. Any participant receiving rescue medication was considered a non-responder. Platelet transfusions were considered rescue medication.|Treatment Period (4 weeks)|Efficacy Analysis Set, composed of all enrolled participants who received romiplostim and completed the treatment phase.||Participants|||Number
720844|NCT00303485|Secondary|Number of Participants With Any Adverse Event or Serious Adverse Event|An Adverse Event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. A Serious Adverse Event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.|Up to 7 months|The Safety Analysis Population was a subset of the ITT Population consisting of participants with at least 1 post-baseline safety assessment.||Participants|||Number
720845|NCT00303485|Secondary|Number of Participants With Any Marked Abnormality in Laboratory Parameters|Marked laboratory abnormalities are those which exceed the marked abnormality range (i.e., greater or less than the Roche defined marked abnormality range; i.e Low or High) and which also represents a clinically relevant change from Baseline of at least a designated amount. The indicated abnormal laboratory parameters (along with their marked reference range) are as follows : Hematocrit (0.31- 0.56 fraction), hemoglobin (110 - 200 g/L), platelets (100 – 550 *10^9/L), white blood cell (WBC) (3.0 - 18.0 *10^9/L), alanine aminotransferase (ALT) (0 – 110 U/L), creatinine (0 – 154 µmol/L), chloride (95 – 115 mmol/L), phosphate (0.75 - 1.60 mmol/L ). Creatinine clearance was calculated using the Cockroft-Gault formula.|Up to 7 months|The Safety analysis Population was a subset of the ITT Population consisting of participants with at least 1 post-baseline safety assessment. ‘n’ denotes the number of participants who received the indicated study drug for each arm.||Participants|||Number
720846|NCT00303485|Secondary|Difference Between the Minimum and Maximum Relative Percent Change in Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentrations|Overall minimum and maximum relative percent change in sCTX concentrations from Baseline were calculated for all participants over D7, D14, D21 and D28 of Month 6 and the difference between it was analyzed.|Day (D)7, D14, D21 and D28 of Month 6|This analysis was performed on the ITT Population. The ITT Population included all randomized participants who received at least 1 dose of study medication.||Percent change||Full Range|Median
721051|NCT00318409|Primary|Tolerability: Comparison of Adverse Events in the Bupropion and Placebo Arms.||throughout study|||number of adverse events|||Number
720847|NCT00303485|Secondary|Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.321 ng/mL|Percentage of participants whose sCTX concentration was between 0.011 and 0.321 ng/mL (Mean -2 to + 0 SD) were analyzed at particular time points. Mean and SD are based on the normal range for premenopausal women: Mean = 0.321 ng/mL, SD = 0.155 ng/mL.|Baseline (Visit 1), Day (D)3 of M1, and D7, D14, D21, D28 of each M1, M2, M3, M4, M5, M6|This analysis was performed on the ITT Population. The ITT Population included all randomized participants who received at least 1 dose of study medication. ‘n’ denotes number of participants who received the indicated study drug for each arm.||Percentage of participants|||Number
720848|NCT00303485|Secondary|Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.476 ng/mL|Percentage of participants whose sCTX concentration was between 0.011 and 0.476 ng/mL (Mean -2 to + 1 SD) were analyzed at particular time points. Mean and SD are based on the normal range for premenopausal women: Mean = 0.321 ng/mL, SD = 0.155 ng/mL. Baseline visit was defined as Visit 1.|Baseline (Visit 1) and Day (D)3 of M1 and D7, D14, D21, D28 of each M1, M2, M3, M4, M5, M6|This analysis was performed on the ITT Population. The ITT Population included all randomized participants who received at least 1 dose of study medication. ‘n’ denotes number of participants who received the indicated study drug for each arm.||Percentage of participants|||Number
720849|NCT00303485|Secondary|Percentage of Participants With a Serum C-terminal Telopeptide of Type1 Collagen (sCTX) Concentration Between 0.011 and 0.631 ng/mL and Who Have Achieved a Decrease in sCTX Concentration of at Least 8 Percent|The Cochran-Mantel Haenszel test stratified by Baseline sCTX category was used to compare the 2 treatment groups for proportion of participants whose sCTX concentration was between 0.011 and 0.631 ng/mL (premenopausal normal range mean +/- 2 SD) who achieved a decrease in sCTX of at least 8% from Baseline. Mean and SD are based on the normal range for premenopausal women: Mean = 0.321 ng/mL, SD=0.155 ng/mL. Baseline visit was defined as Visit 1.|Baseline (Visit 1) and Day (D)3 of Month (M)1 and; D7, D14, D21, D28 of each M1, M2, M3, M4, M5, and M6|This analysis was performed on the ITT Population. The ITT Population included all randomized participants who received at least 1 dose of study medication. ‘n’ denotes number of participants who received the indicated study drug for each arm.||Percentage of participants|||Number
720850|NCT00303485|Secondary|Relative Percent Change in Parathyroid Hormone (PTH) From Baseline to Post Treatment Assessments|Parathyroid hormone (PTH) regulates calcium and phosphate metabolism in bone and kidney, and is measured in picogram/milliliter (pg/mL). The relative percent change in PTH was defined as the relative difference between the value at each time point and the value at Baseline, using the following formula: Relative change = (PTH time point- PTH Baseline) / (PTH Baseline) * 100. Post treatment assessments were done at Baseline, Month (M)1 Day (D)7, and M6D7|Baseline (Visit 1), Month (M)1 Day (D)7, and M6D7|This analysis was performed on the ITT Population. The ITT Population included all randomized participants who received at least 1 dose of study medication.||Percent change||95% Confidence Interval|Median
720851|NCT00303485|Secondary|Relative Percent Change in Bone Specific Alkaline Phosphatase (BSAP) Concentration From Baseline Over Time|BSAP is a biochemical marker of bone formation and measured in units per litre (U/L). The relative percent change in BSAP was defined as the relative difference between the value at each time point and the value at Baseline, using the following formula: Relative change = (BSAP time point- BSAP Baseline) / (BSAP Baseline) * 100. The greater the percent decrease from Baseline, the greater the response to therapy. Baseline visit was defined as Visit 1.|Baseline (Visit 1), Day (D) 7 and D 28 of Month (M)1, M2, M3, M4, M5, M6|This analysis was performed on the ITT Population. The ITT Population included all randomized participants who received at least 1 dose of study medication. ‘n’ denotes number of participants who received the indicated study drug for each arm.||Percent change||95% Confidence Interval|Median
720852|NCT00303485|Secondary|Relative Percent Change in Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration From Baseline Over Time|sCTX is a biochemical marker for bone turnover that has been shown to detect increased bone resorption, a process by which bone is broken down within the body. The relative change in sCTX was defined as the relative difference between the value at each time point and the value at Baseline, using the following formula: Relative change = (sCTX Time point- sCTX Baseline) / (sCTX Baseline) * 100. The sCTX value used for Baseline was the average of the results from the 2 blood samples taken at screening. If 1 of these 2 samples was nonquantifiable or missing, then the Baseline sCTX was the result from the non-missing sample. Baseline visit was defined as Visit 1.|Baseline (Visit 1), Day (D) 3, D7, D14, D21, D28 of Month (M)1, M2, M3, M4, M5, M6|This analysis was performed on the ITT Population. The ITT Population included all randomized participants who received at least 1 dose of study medication. “n” denotes number of participants who received the indicated study drug for each arm.||Percent change||95% Confidence Interval|Median
720853|NCT00303485|Primary|Relative Percent Change in Serum C-terminal Telopeptide of Type 1 Collagen Concentration (sCTX) From Baseline to Day 3|Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) is a biochemical marker for bone turnover that has been shown to detect increased bone resorption, a process by which bone is broken down within the body. It is measured in units of nanograms (ng) per milliliter (mL). The relative change in sCTX was defined as the relative difference between the value at each time point and the value at Baseline, using the following formula: Relative change = (sCTX time point- sCTX Baseline) / (sCTX Baseline) * 100. The sCTX value used for Baseline was the average of the results from the 2 blood samples taken at screening. If 1 of these 2 samples was nonquantifiable or missing, then the Baseline sCTX was the result from the non-missing sample. Baseline visit was defined as Visit 1.|Baseline (Visit 1) and Day 3|This analysis was performed on the ITT Population. The ITT Population included all randomized participants who received at least 1 dose of study medication.||Percent change||95% Confidence Interval|Median
720854|NCT00303511|Primary|Feasibility of Pacemaker Implant With Total Thoracoscopic Approach to Epicardial Pacing Lead|The ability to place a pacemaker with capture (have the pacemaker work properly) through totally thoracoscopic approach to epicardial pacing lead without requiring conversion to open procedure|30 days|||percentage of particiapants|||Number
720855|NCT00303602|Secondary|Mean Change From Baseline to 16 Week Endpoint in the Global Assessment of Functioning (GAF) Scale|Measures physician's judgment of a patient's overall level of functioning. Ratings are based on a scale of 1 to 100, with the following classification range: 1-10 (severely impaired) to 91-100 (superior functioning).|Visit 2 (Baseline) and Visit 7 (Week 16)|Intention to treat||units on a scale||Standard Error|Least Squares Mean
721052|NCT00318409|Primary|Feasibility: Participants Who Completed the Trial||12 weeks|||participants who completed the trial|||Number
720856|NCT00303602|Secondary|Mean Change From Baseline to 16 Week Endpoint in the Subjective Well-Being Under Neuroleptics (SWN) Scale|Measures subjective well-being for previous 7 days. 20 items covering 5 health domains (subscales) (4 items each): emotional regulation, self-control, mental functioning, social integration, and physical functioning. Individual scores range from 1 (not at all) to 6 (very much). Subscale scores range from 1 to 24. Total score ranges from 1 to 120.|Visit 2 (Baseline) and Visit 7 (Week 16)|Intention to treat||units on a scale||Standard Error|Least Squares Mean
720857|NCT00303602|Secondary|Mean Change From Baseline to 16 Week Endpoint in the Clinical Global Impression-Severity (CGI-S) Scale|Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Visit 2 (Baseline) and Visit 7 (Week 16)|Intention to treat||units on a scale||Standard Error|Least Squares Mean
720858|NCT00303602|Secondary|Number of Participants Meeting a Definition for the Presence of Metabolic Syndrome as Defined by Adult Treatment Panel III (ATP III) Criteria at Baseline and 16 Week Endpoint|Patient meets definition of metabolic syndrome if they have >=3 risk factors: Waist circumference (men>102cm, women>88cm); triglycerides >=1.7mmol/L; HDL cholesterol (men<1.04mmol/L, women<1.30mmol/L); blood pressure >135/>=85 mmHg; Fasting glucose >=6.1mmol/L|Visit 2 (Baseline) and Visit 7 (Week 16)|Intention to treat||participants|||Number
720859|NCT00303602|Secondary|Mean Changes From Baseline to 16 Week Endpoint Homeostasis Model Assessments of Insulin Sensitivity HOMA-S (Calculated)|HOMA-S is an estimate of insulin sensitivity. The HOMA model is a computer model of the glucose insulin feedback system in the fasted state. The model consists of a number of non-linear empirical equations describing the functions of organs and tissues involved in glucose regulation.|Visit 2 (Baseline) and Visit 7 (Week 16)|Safety population with last observation carried forward.||percent sensitivity||Standard Deviation|Mean
720860|NCT00303602|Secondary|Mean Change From Baseline to 16 Week Endpoint in Glycosylated Hemoglobin||Visit 2 (Baseline) and Visit 7 (Week 16)|Safety population with last observation carried forward||percent||Standard Deviation|Mean
720861|NCT00303602|Secondary|Mean Change From Baseline to 16 Week Endpoint in Fasting Serum Insulin|Patients should be fasting a minimum of eight hours prior to serum insulin measurement.|Visit 2 (Baseline) and Visit 7 (Week 16)|Safety population with last observation carried forward||microIU/milliliter||Standard Deviation|Mean
720862|NCT00303602|Secondary|Change From Baseline to 16 Week Endpoint in Fasting Plasma Glucose|Patients should be fasting a minimum of eight hours prior to plasma glucose measurement.|Visit 2 (Baseline) and Visit 7 (Week 16)|Safety population with last observation carried forward||millimole/Liter||Standard Deviation|Mean
720863|NCT00303602|Secondary|Mean Change From Baseline to 16 Week Endpoint in Fasting Lipoproteins (Total Cholesterol, High-Density Lipoprotein Cholesterol [HDL-Cholesterol], Low-Density Lipoprotein Cholesterol [LDL-Cholesterol] [Calculated], and Triglycerides)|Patients should be fasting a minimum of eight hours prior to lipoprotein measurements.|Visit 2 (Baseline) and Visit 7 (Week 16)|Safety population with last observation carried forward||millimole/Liter||Standard Deviation|Mean
720864|NCT00303602|Secondary|Mean Change From Baseline to 16 Week Endpoint in Blood Pressure|Sitting blood pressure, taken from the same arm.|Visit 2 (Baseline) and Visit 7 (Week 16)|Safety population with last observation carried forward||mm Hg||Standard Deviation|Mean
720865|NCT00303602|Secondary|Change From Baseline to 16 Week Endpoint in Subjective Appetite Using a Visual Analog Scale|Participant chooses where they think their appetite lies on a 10 centimeter line between two anchors (0 - very poor appetite and 10 - very strong appetite). The possible range of scores is 0 to 100 and represents millimeters on the 10 centimeter line.|Visit 2 (Baseline) and Visit 7 (Week 16)|Intention to treat||units on a scale||Standard Error|Least Squares Mean
720866|NCT00303602|Secondary|Number of Participants Discontinuing the Trial by Visit (Week)|The number of participants who discontinued by visit (non-cumulative).|Visit 2 (Baseline) to Visit 7 (Week 16)|Intention to treat||participants|||Number
720867|NCT00303602|Secondary|Number of Patients Achieving at Least 5% Loss of Body Weight in Any Post-Baseline Period|Percentage loss of body weight = 100*(postbaseline weight - baseline weight)/baseline weight|Visit 2 (Baseline) to Visit 7 (Week 16)|Intention to treat||participants|||Number
720868|NCT00303602|Secondary|Mean Change From Baseline to 16 Week Endpoint in Waist Circumference|Waist circumference is measured on a bare abodomen just above the hip bone.|Visit 2 (Baseline) and Visit 7 (Week 16)|Intention to treat with last observation carried forward||centimeters||Standard Deviation|Mean
720869|NCT00303602|Secondary|Mean Change From Baseline to 16 Week Endpoint in Weight|Weight of undressed patient (undergarments allowed), measured preferably at the same time each day.|Visit 2 (Baseline) and Visit 7 (16 Weeks)|Intention to treat||kilograms||Standard Error|Least Squares Mean
720870|NCT00303602|Secondary|Mean Change From Baseline to 16 Week Endpoint in Body Mass Index (BMI) for the Treatment Completers|Body mass index is an estimate of body fat based on body weight divided by height squared. Comparisons of change from baseline to endpoint between participants who completed their treatment. Change = Endpoint value minus Baseline value.|Visit 2 (Baseline) and Visit 7 (16 Weeks)|Per protocol||kilograms/square meters||Standard Deviation|Mean
720871|NCT00303602|Secondary|Mean Change From Baseline to 16 Week Endpoint in Body Mass Index (BMI)|Body mass index is an estimate of body fat based on body weight divided by height squared. Comparison of change from baseline to endpoint. Change = Endpoint (Week 16) minus Baseline (Week 0)|Visit 2 (Baseline) and Visit 7 (Week 16)|Intention to treat with last observation carried forward||kilograms/square meters||Standard Deviation|Mean
720872|NCT00303602|Primary|Time Course of Change From Baseline in Body Mass Index (BMI)|Body mass index is an estimate of body fat based on body weight divided by height squared. Comparison of changes at various time points throughout the study. Change = Time point value minus baseline (Visit 2) value.|Visit 2 (Baseline) to Visit 7 (16 Weeks)|Intention to treat||kilograms/square meters||Standard Error|Least Squares Mean
720901|NCT00303953|Secondary|Progression-free Survival|Measured from date of registration to time of first documentation of progression or death, or last contact date. Progression is defined as a 50% increase in sum of products of greatest diameters (SPD) of target measurable lesions over the smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline; appearance of a new lesion/site; unequivocal progression of non-measurable disease in the opinion of the treating physician; death due to disease without prior documentation of progression.|assessed at week 8, then every 3 months for 3 years|Only eligible patients were included in the analyses.||years||95% Confidence Interval|Median
720873|NCT00303628|Other Pre-specified|Change in Oxaliplatin-related Neurotoxicity Between Baseline and 12 Months|Change in oxaliplatin-related neurotoxicity between baseline and 12 months was measuring the long-term symptom of oxaliplatin-related neurotoxicity among the patients. Oxaliplatin-related neurotoxicity was measured using the FACT/GOG-Ntx subscale at baseline and 12 months after randomization. The range of the total score of the scale was between 0 and 44, and lower values indicate higher neurotoxicity. Change in oxaliplatin-related neurotoxicity between baseline and 12 months= total score at 12 months - total score at baseline. A negative value indicated worsened symptom. This change in score was calculated for each individual patient who had the data.|assessed at baseline and 12 months after randomization|Patients with data about their oxaliplatin-related neurotoxicity measured using FACT/GOG Ntx subscale at both baseline and 12 months after randomization. Due to the early termination of the trial, the sample size was quite small for the endpoint. Consequently, it was considered as an exploratory endpoint.||scores on a scale||Standard Deviation|Mean
720874|NCT00303628|Other Pre-specified|Change in Rectal Function Between Baseline and 12 Months|Change in rectal function between baseline and 12 months was measuring the long-term rectal function among the patients. Rectal function was measured using the Bowel Function Questionnaire at baseline and 12 months after randomization. The total score of the questionnaire was calculated as the number of problems with bowel function (score range 0-11). Change in rectal function between baseline and 12 months= total score at 12 months - total score at baseline. A negative value indicated improved rectal function. This change in score was calculated for each individual patient who had the data.|assessed at baseline and 12 months after randomization|Patients with data about their rectal function measured using the Bowel Function Questionnaire at both baseline and 12 months after randomization. Due to the early termination of the trial, the sample size was quite small for the endpoint. Consequently, it was considered as an exploratory endpoint.||scores on a scale||Standard Deviation|Mean
720875|NCT00303628|Secondary|Proportion of Patients Who Completed 12 Cycles of Treatment|In the study, treatment was repeated every 2 weeks for a total of 12 cycles on both arms. The total number of cycles of treatment patient received until going off treatment due to any reason was recorded. It was a measure of the tolerance of the therapy.|assessed at the end of treatment|Patients who received at least one cycle of protocol treatment||proportion of participants|||Number
720876|NCT00303628|Secondary|Patterns of Failure|Failure included recurrence, second primary cancer and death without recurrence.|Follow-up assessments performed every 3 months for patients < 2 years from randomization, every 6 months for patients 2-5 years from randomization, and every 12 months for patients 5-10 years from randomization|all randomized patients||participants|||Number
720877|NCT00303628|Secondary|5-year Disease-free Survival Rate|Disease-free survival (DFS) was defined as time from randomization to recurrence, second invasive primary cancer or death, whichever occurred first. Patients who were still alive and had no DFS events were censored at the last disease assessment date known to be free of DFS events. Kaplan-Meier method was used to estimate 5-year DFS rate.|Follow-up assessments performed every 3 months for patients < 2 years from randomization, every 6 months for patients 2-5 years from randomization, and every 12 months for patients 5-10 years from randomization|All randomized patients (intent-to-treat population)||proportion of participants||95% Confidence Interval|Number
720878|NCT00303628|Primary|5-year Overall Survival Rate|Overall survival (OS) was defined as time from randomization to date of death from any cause. Patients who were still alive were censored at last date of known alive. Kaplan-Meier method was used to estimate the 5-year OS rate.|Follow-up assessments performed every 3 months for patients < 2 years from randomization, every 6 months for patients 2-5 years from randomization, and every 12 months for patients 5-10 years from randomization|All randomized patients (intent-to-treat population)||proportion of participants||95% Confidence Interval|Number
720879|NCT00303667|Secondary|Incidence of Post-transplant Lymphoproliferative Disorder (PTLD)|Post-transplant lymphoproliferative disorder (PTLD) is a virally-driven cancer of the lymphoid cells caused by immunosuppressive drugs taken after allogeneic stem cell transplantation to prevent or control graft versus host disease.|1 Year|||participants|||Number
720880|NCT00303667|Primary|Disease-free Survival at 1 Year|Number of patients alive without evidence of disease at 1 year after transplant|1 Year|||participants|||Number
720881|NCT00303667|Secondary|Number of Patients With Disease Relapse|Disease relapse is the recurrence of leukemia in patients who had cleared their leukemia after treatment. Patients with persistent leukemia are not evaluable for relapse.|1 Year|On the extended schema, 16/39 patients either did not clear their leukemia or died before relapse would have been detected (day 28), and thus were not evaluable for relapse.||participants|||Number
720882|NCT00303667|Secondary|Incidence of Chronic Graft Versus Host Disease|Chronic graft versus host disease is a severe long term complication created by infusion of donor cells into a foreign host|1 Year|||participants|||Number
720883|NCT00303667|Secondary|Number of Patients With Treatment-Related Mortality|Death within the first 100 days related to treatment in patients without relapse or persistent disease.|Day 100|||participants|||Number
720884|NCT00303667|Secondary|Incidence of Grade III-IV Acute Graft Versus Host Disease|Grade III-IV acute graft versus host disease is a severe short term complication created by infusion of donor cells into a foreign host|Month 6|||participants|||Number
720885|NCT00303667|Secondary|Number of Patients With Graft Failure|Number of patients with graft failure defined as <500 donor neutrophils count by day 28 in the absence of residual or relapsed leukemia|Day 28|On the short schema, 1 of the 8 patients, and on the extended schema, 6 of the 39 patients, died prior to Day 28, the day on which engraftment was assessed. Thus, only 7 and 33 patients respectively were evaluable for that endpoint.||participants|||Number
720886|NCT00303667|Secondary|In Vivo Expansion of a Donor NK Cells NK Cell Product|Number of patients with in vivo expansion of donor NK cells. In vivo expansion of NK cell is defined as detection of >100 donor-derived NK cells per microliter of blood.|12 - 14 days after NK cell infusion|The protocol was amended to add this endpoint after the 8 subjects were enrolled on the short schema. Thus the relevant samples to determine NK expansion were not collected. On the extended schema, 3 of 39 patients died prior to the day on which in vivo donor NK cell expansion was assessed. Thus only 36 patients were evaluable for that endpoint.||participants|||Number
720887|NCT00303667|Primary|Disease-free Survival at 6 Months|Number of patients alive without evidence of disease at 6 months after transplant|Month 6|||participants|||Number
721053|NCT00318409|Primary|Feasibility: Proportion of Urine Samples Collected||12 weeks|||Urine samples collected|Participants||Number
720903|NCT00303953|Primary|Assess Number of Patients Who Achieve Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR)|Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the SPD for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.|assessed at week 8, and every 3 months for 3 years|All eligible patients who started treatment were included in assessing response estimates.||participants|||Number
720904|NCT00303966|Secondary|Changes in Plasma Level of Interleukin-8 (IL-8) From Baseline to Week 25|The change (post-pretreatment) will be calculated and tested using a paired t test. A negative value indicates a decrease with treatment.|Baseline and week 25|Study terminated early and enrolled only 5 patients. Data wasn't collected for this outcome.|||||
720905|NCT00303966|Secondary|Changes in Vascular Endothelial Growth Factor (VEGF) From Baseline to Week 25|Changes in VEGF levels (post-pretreatment) will be assessed. A negative value indicates a decrease with treatment.|Baseline and week 25|Study terminated early after enrolling only 5 patients. Data wasn't collected for this outcome.|||||
720906|NCT00303966|Secondary|Changes in Mean Microvessel Density From Baseline to Week 25|Mean microvessel density will serve as a marker of angiogenesis (other markers includes hot spot density). Will be examined using random-effects linear models.|Baseline and week 25|Study terminated early with only 5 patients. Data wasn't collected for this outcome.|||||
720907|NCT00303966|Primary|Overall Survival|Overall survival will be defined as time from the start of treatment until death from any cause and will be evaluated using the Kaplan-Meier estimator.|Up to 5.5 years|Study terminated early and only 5 patients were enrolled.||months||Standard Error|Median
720908|NCT00303966|Primary|Time to Disease Progression|Time to disease progression will be defined as the time from treatment start until disease progression and will be evaluated using the Kaplan-Meier estimator. Those who do not progress will be censored at the time that they were last known to be progression free.|Up to 5.5 years|Study terminated early and only 5 patients were enrolled.||months||Standard Error|Median
720909|NCT00303966|Primary|Objective Response Rate|Objective response is defined as a complete (CR) or partial (PR) remission. Complete remission is defined as no evidence of chronic lymphocytic leukemia (CLL) in marrow with normal hematopoiesis and no palpable lymphadenopathy. Partial remission is defined as improvement in blood counts from baseline with >50% reduction in lymph nodes on examination. These are definitions from the CLL International Working Group (IWG).|Up to week 25|||percentage of participants||95% Confidence Interval|Number
720910|NCT00303979|Secondary|Observe the Relative Improvement From Baseline to 18M in Composite Score for the Aggregate Practices.|Performance measure improvement for Composite Score analyzed at a practice level for Cohort C (18 Month) will be presented.|18 Month|||Percentage|Participants|Standard Deviation|Mean
720911|NCT00303979|Secondary|Observe the Relative Improvement From Baseline to 6M in Composite Score for the Aggregate Practices.|Performance measure improvement for Composite Score analyzed at a practice level for Cohort B (6 Month) will be presented.|6 Month|||Percentage|Participants|Standard Deviation|Mean
720912|NCT00303979|Secondary|Observe the Relative Improvement From Baseline to 24M in Composite Score for the Aggregate Practices.|Performance measure improvement for Composite Score analyzed at a practice level for Cohort A (longitudinal) will be presented.|24 months|||percentage|Participants|Standard Deviation|Mean
720913|NCT00303979|Secondary|Evaluate the Proportion of Sites That Demonstrate a Relative 20% or Greater Improvement in 2 or More of the 7 Performance Measures at 24 Months as Compared to Baseline.|The proportion of practices that achieved greater than or equal to 20% improvement in two or more of the 7 performance measures at 24 months as compared to baseline will be presented.|Study Completion|||Sites|Participants||Number
720914|NCT00303979|Primary|To Observe Over the Aggregate IMPROVE-HF Practice Sites a Relative 20% or Greater Improvement in at Least 2 of the 7 Performance Measures at 24 Months Compared With Baseline.|The percent of patients that conformed to each performance measure will be calculated at baseline and 24 months. Based on the definition of each performance measure as defined in the performance measure constructs, each performance measure’s baseline percentage and 24 month percentage will be calculated. The change in percentages from baseline is the baseline percentage subtracted from the 24 month percentage. Each performance measure will be evaluated separately to determine whether there is a relative 20% or greater improvement from baseline. The difference in percentages from baseline to 24 months and associated 95% confidence intervals on the differences will be presented. The percent improvement from baseline for each performance measure will be tested using a large sample test (z-test) on a proportion.|24 Month|167 practices contributed data to the baseline chart review. Twelve of the practices withdrew from the study prior to the next chart review milestone. 155 of those practices’ data contributed to the follow up of the longitudinal cohort time points of 12 and 24 months post educational workshop.||Num. of measures with 20%+ improvement|||Number
720915|NCT00304031|Secondary|Correlation of PFS With OS at 6 Months||From randomization to date of progression, death or last follow-up. Analysis occurs after 647 deaths have been reported.||||||
720916|NCT00304031|Secondary|Toxicity||From start of treatment to end of follow-up||||||
720917|NCT00304031|Secondary|Correlation of Tumor MGMT Gene Methylation Status With Treatment Response||From randomization to date of progression, death or last follow-up. Analysis occurs after 647 deaths have been reported.||||||
720918|NCT00304031|Secondary|Comparison of OS and PFS in Patients With Methylated MGMT||From randomization to date of progression, death or last follow-up. Analysis occurs after 647 deaths have been reported.||||||
720919|NCT00304031|Secondary|Comparison of OS and PFS in Patients With Unmethylated MGMT||From randomization to date of progression, death or last follow-up. Analysis occurs after 647 deaths have been reported.||||||
720920|NCT00304031|Secondary|Progression-free Survival (PFS)||From randomization to date of progression, death or last follow-up. Analysis occurs after 647 deaths have been reported.||||||
720921|NCT00304031|Primary|Overall Survival (OS)||From randomization to date of death or last follow-up. Analysis occurs after 647 deaths have been reported.|Eligible patients who were randomized to an adjuvant temozolomide arm and contributed follow-up data.||months||95% Confidence Interval|Median
720923|NCT00304070|Secondary|Molecular Alterations and Embryonal Markers in Children With ACT - A43 del33bp Mutation of (Beta)-Catenin.|The number of eligible patients who have A43 del33bp mutation of (beta)-catenin.|Patients who had surgery at time of enrollment.|Fifty-eight eligible patients had material examined for the presence of (beta)-catenin mutations.||Participants|||Count of Participants
720924|NCT00304070|Secondary|Incidence and Type of Germline TP53 Mutations in Non-Brazilian Children and Children From Southern Brazil by Deoxyribonucleic Acid (DNA) Sequencing and Affymetrix Gene Chip Analysis.|The proportion of patients in each subpopulation are compared.This test is dependent on the number of patients from whom blood can be obtained as well as the frequency of the relevant mutation in each group.|At study enrollment|The proportion of patients in each subpopulation are compared.This test is dependent on the number of patients from whom blood can be obtained as well as the frequency of the relevant mutation in each group (Number of patients from Brazil: 23. Number of patients not from Brazil: 31)||participants|||Number
720925|NCT00304070|Secondary|Frequency of Lymph Node Involvement by Imaging.|The number eligible patients who have lymph node involvement by imaging at study enrollment.|At study enrollment|Seventy-five eligible patients had tumor imaging done at the time of study enrollment and evaluated for the presence of lymph node involvement||Participants|||Count of Participants
720926|NCT00304070|Secondary|Complications Associated With Radical Adrenalectomy and RLND|Any patient who dies because of surgery or has a grade 3 or 4 toxicity possibly, probably or likely related to surgery will be considered as having experienced a surgical complication. The complication rate is estimated as the proportion of evaluable patients that have a complication.|Up to 1 month after surgery|Sixty-nine eligible patients received surgery of the primary tumor site or RPLND. Complication rates were considered over the entire population regardless of Arm/Group assignment. One patient had grade 3 abdominal pain attributed to surgery.||participants|||Number
720927|NCT00304070|Secondary|Toxicity Associated With Chemotherapy Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0|The proportion of patients assigned to receive chemotherapy that experience CTC Version 4 grade 3 or higher anemia at any time during protocol therapy|Up to 182 Days After Enrollment|||participants|||Number
720928|NCT00304070|Primary|Five Year Event-free Survival (EFS)|The model used for comparison will be an exponential model with a constant failure rate of 0.053 (stratum I), 0.347 (stratum II), 0.602 (stratum III and IV) per year for the first two years and 0 after that. The one-sample one-sided log-rank test comparing the observed data with the hypothesized model (Woolson, 1981) of size 0.05 will be used to assess whether the data are consistent with the target models. Since this test has independent increments, the method of Lan and DeMets will be used to derive the p-values for testing procedure.|Up to five years after enrollment|||Estimated probability five year EFS||95% Confidence Interval|Number
720929|NCT00304096|Secondary|The Number of Participants With T-cell Responses Against the Vaccine as Measured by Elispot Assay After 14 Day in Vitro Sensitization||Days 1-78|||participants|||Number
720930|NCT00304096|Primary|The Number of Participants Who Experienced Dose-limiting Adverse Events|Safety of the 9-peptide mixture if fewer than 33% of patients experience a dose-limiting toxicity|30 days post administration of last vaccine|||participants|||Number
720931|NCT00313443|Secondary|Presence of Any Adverse Effect Attributable to Amiodarone.|Number of patients developing adverse effects by amiodarone leading to withdrawal or specific treatment (i.e. thyroid hormone treatment)|Cumulated time on amiodarone (varies in each patient)|||Patients|||Number
720932|NCT00313443|Secondary|Pain and Complications (if Any) Caused by Fat Tissue Needle Aspirations|Number of patients having complications (if any) caused by fat tissue needle aspirations|24 hours after needle aspiration|||Patients|||Number
720933|NCT00313443|Primary|Relationship Between Amiodarone Concentrations in Fat Tissue and Developing Adverse Effects.|Relationship between amiodarone concentrations in fat tissue (mean of two different samplings and developping adverse effects.|Cumulated time on amiodarone (varies in each patient)|||Logistic regression OR|||Number
720934|NCT00313443|Primary|Relationship Between Amiodarone Concentrations in Fat Tissue and in Plasma.|Correlation between amiodarone concentrations in fat tissue (mean of 2 samples) and simultaneous concentration in plasma.|One single measure, taken just before daily administration|||Correlation coefficient R|||Number
720935|NCT00313443|Primary|Relationship Between Amiodarone Concentration in Fat Tissue and Cumulated Dose.|Correlation between amiodarone concentration in fat tissue (mean from several sampling points) and cumulated dose.|One single measure|||Correlation coefficient R|||Number
720936|NCT00313586|Primary|Proportion of Patients With Clinical Response|"Clinical response is defined as a complete response (CR), partial response (PR) or trilineage response (TR) graded according to the following criteria:
World Health Organization classification of the acute leukemias and myelodysplastic syndrome (by Bennett)
Myelodysplastic syndromes standardized response criteria: further definition (by Cheson et al.)
Report of an international working group to standardize response criteria for myelodysplastic syndromes (by Cheson et al.)"|Assessed every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2 - 5 years from study entry.|All treated patients are included in the analysis.||Proportion of patients||95% Confidence Interval|Number
720937|NCT00313612|Secondary|Time to Disease Progression by RECIST and/or CA 125|Time to disease progression by RECIST and/or CA 125|Tumor measurements will be performed every 8 weeks until the date of first documented progression up to 100 weeks|||months||95% Confidence Interval|Median
720938|NCT00313612|Primary|Clinical Response Rate (Complete and Partial Response by RECIST and/or CA [Cancer Antigen] 125)|Tumor response was assessed every two cycles by CT/MRI using RECIST (Response Evaluation Criteria in Solid Tumors) criteria. Per Response Evaluation Criteria in Solid Tumors (RECIST 1.0) for target lesions: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): >= 30% decrease in the sum of the longest diameter (LD) of target lesions; Overall Response (OR) = CR + PR.|Every two cycles for up to 24 weeks.|30 patients were analyzed. Eight patients discontinued treatment before 2 cycles.||participants|||Number
720939|NCT00313703|Other Pre-specified|Number of Participants Who Reported Headache Disability Scores (MIDAS) More Than Minimal|Headache disability scores. On the MIDAS scale, a score > five signifies more than minimal headache related disability. MIDAS stands for MIgraine Disability Assessment Scale. More information on it can be found at http://www.migraines.org/disability/pdfs/midas.pdf. Scores of 0 are desirable. Scores greater than 20 signify a severe, functionally disabling migraine disorder.|3 months|A small number of patients in each group were lost-to-follow-up and could not be included in this analysis.||participants|||Number
720940|NCT00313703|Primary|Number of Participants Who Report Moderate or Severe Pain Within 24 Hours of Emergency Department(ED) Discharge|Moderate/ Severe pain after discharge from the Emergency Department (ED). Moderate and severe are study subject's description of pain|24 hours after Emergency Department (ED) discharge|A small number of patients in each group were lost-to-follow-up and could not be included in this analysis.||Participants|||Number
720941|NCT00313716|Secondary|Incidence of Infection|occurrence of infection was a primary safety outcome for the transfusion threshold randomization|within 30 days after injury|Intention to treat analysis||participants|||Number
720942|NCT00313716|Secondary|Incidence of Adult Respiratory Distress Syndrome (ARDS)|development of ARDS was a primary safety outcome for the transfusion threshold randomization|within 30 days after injury|Intention to treat analysis||participants|||Number
720943|NCT00313716|Secondary|Mortality Rate|mortality rate was a secondary outcome measure for the Epo randomization, and a primary safety outcome measure for the transfusion threshold randomization|up to 6 months after injury|Intention to treat analysis||participants|||Number
720944|NCT00313716|Secondary|Disability Rating Scale|Disability rating scale was a secondary outcome measure for the transfusion threshold analysis. Disability rating scale ranges from 0 to 30, with 30 indicating death and 0 indicating return to normal status.|at 6 months|Intention to treat analysis||units on a scale||Inter-Quartile Range|Median
720945|NCT00313716|Primary|Glasgow Outcome Scale|Dichotomized to favorable outcome (good recovery or moderate disability) or to unfavorable outcome (severe disability or vegetative or dead)|at 6 months after injury|Intention to treat. Multiple imputation for missing 6-month GOS data was performed assuming data were missing at random using chained equations (R, R Foundation for Statistical Computing).The imputation was based on a logistic regression model with baseline covariates. Results were aggregated over 20 imputed sets using variance formula by Rubin.||participants|||Number
720946|NCT00316862|Secondary|Proportion of Patients Experiencing Grade 3 or Greater Hematologic and Non-hematologic Toxicity|Proportion of patients experiencing grade 3 or greater hematologic and non-hematologic toxicity, deemed as at least possibly related to treatment, graded using the NCI CTCAE version 3.0|Up to 5 years|1 participant was not evaluated for adverse events.||percentage of participants|||Number
720947|NCT00316862|Secondary|Proportion of Patients Experiencing Grade 3 or Greater Pneumonitis or Esophagitis|Proportion of patients experiencing grade 3 or greater pneumonitis or esophagitis, deemed at least possibly related to treatment graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0|Up to 5 years|1 participant was not evaluated for adverse events.||percentage of participants|||Number
720948|NCT00316862|Secondary|Patterns of Failure||Up to 5 years||||||
720949|NCT00316862|Secondary|Overall Survival||Up to 5 years||||||
720950|NCT00316862|Secondary|Disease-free Survival||Up to 5 years||||||
720951|NCT00316862|Secondary|Utility of Early PET Imaging in Predicting Response to Treatment||Up to 55 days||||||
720952|NCT00316862|Primary|Proportion of Patients With Adenocarcinoma Achieving a Pathologic Complete Response (CR) After Surgery|A pathological complete response is defined as no tumor found on pathology review at surgery in all resected lymph nodes and tissue. All tissues sampled must have NO viable tumor|Up to 5 years|27 participants with adenocarcinoma were recruited and evaluated for the primary outcome per protocol design.||percentage of participants||95% Confidence Interval|Number
720953|NCT00316888|Secondary|3-year Colostomy-free Survival Rate|Colostomy-free survival was defined as time from registration until time of colostomy or death without colostomy, censoring cases without colostomy at the data of last disease assessment documenting the patient was free of colostomy. Kaplan-Meier method was used to estimate the 3-year colostomy-free survival rate.|assessed every 3 months for patients within 2 years of registration, then every 6 months for patients in year 3|eligible and treated patients who did not have permanent colostomy at study entry||proportion of participants||95% Confidence Interval|Number
720954|NCT00316888|Secondary|Objective Response Rate|Objective response rate is defined as number of patients with complete response (CR) or partial response (PR) divided by all eligible and treated patients. Responses are evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline. CR is defined as disappearance of all target and non-target lesions. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameters), and/or persistence of one or more non-target lesion(s).|Tumor assessments were made at baseline, within 4 weeks of the completion of protocol treatment, then every 6 months if patient was 1-4 years from registration, yearly if patient was 5-10 years from registration until progression/relapse using the RECIST|eligible and treated patients||proportion of participants||95% Confidence Interval|Number
720955|NCT00316888|Secondary|3-year Progression-free Survival Rate|Progression-free survival (PFS) was defined as time from registration to disease progression, relapse or death (whichever occurred first), censoring cases without PFS events at the date of last disease assessment documenting the patient was free of progression/relapse. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Kaplan-Meier method was used to estimate the 3-year PFS rate.|assessed every 3 months for patients within 2 years of registration, then every 6 months for patients in year 3|eligible and treated patients||proportion of participants||95% Confidence Interval|Number
720956|NCT00316888|Secondary|3-year Overall Survival Rate|Overall survival (OS) is defined as time from registration to death from any cause. Patients alive are censored at the last contact date. Kaplan-Meier method was used to estimate the 3-year OS rate.|assessed every 3 months for patients within 2 years of registration, then every 6 months for patients in year 3|eligible and treated patients||proportion of participants||95% Confidence Interval|Number
720975|NCT00317044|Secondary|Change in Asthma Quality of Life Questionnaire, Standardized Version (AQLQ(S)) Scores From Randomization (Visit 3) to Visit 7|The Asthma Quality of Life Questionnaire, Standardized Version (AQLQ(S))has been developed by and includes 32 questions in 4 domains: activity limitation, symptoms, emotional function, and exposure to environmental stimuli. It is used to measure the physical and emotional impact of the disease in the selected areas of life. Participants must have both baseline and follow up measure to be included in analysis.AQLQ(S) score based on a 7-point scale that ranged from 1 (worst quality of life) to 7 (best quality of life).|From randomization (Visit 3) to Visit 7|||Scores on a scale||Standard Error|Least Squares Mean
720957|NCT00316888|Primary|Local Failure Rate at 3 Years|Local failure was defined as progression/relapse of disease in the anal canal and/or regional organs and/or regional lymph nodes after completion of protocol therapy, or progression during protocol therapy. Lost to follow-up and death (regardless of cause of death) prior to 3 years were also considered as local failures. For the calculation of local failure rate at 3 years, patients were classified into two groups (ie, coded as binary variable): failure (patients with local failure events prior to 3 years) vs. no failure (patients who still alive and had no local failure at 3 years). The binomial proportion and its exact two-sided 80% confidence interval (CI) were used to estimate it.|assessed every 3 months for patients within 2 years of registration, then every 6 months for patients in year 3|eligible and treated patients||proportion of participants||80% Confidence Interval|Number
720958|NCT00316914|Secondary|Change From Baseline in Quality of Life (QOL) at One Month|Quality of Life (QOL) were measured using the Symptom Experience Diary and supplemental quality of life questions. Item score range: 0 (no symptom) to 10 (worst symptom). The score was reversed and transformed into 0 (low QOL) to 100 (best QOL) scale for analysis. Change: score at one month minus score at baseline.|Baseline and One month|Includes all patients with at least one assessment after baseline.||Units on a scale||Standard Deviation|Mean
720959|NCT00316914|Secondary|Change From Baseline in Fatigue Score at One Month|Fatigue was measured by Brief Fatigue Inventory in the scale of 0 (no fatigue) to 10 (fatigue as bad as you can imagine). The item score was reversed and transformed into 0 (low quality of life (QOL)) to 100 (best QOL) scale for analysis. Change: score at one month minus score at baseline.|Baseline and One month|Includes all patients with at least one assessment after baseline.||units on a scale||Standard Deviation|Mean
720960|NCT00316914|Secondary|Percentage of Patients Experiencing Impact on Activities of Daily Living (ADL)|Activities of daily living were measured using the Symptom Experience Diary and supplemental quality of life questions. The questionnaires' items were in the scale of 0 (no symptom) to 10 (worst symptom).|127 days|Data was collected but not analyzed for this outcome.|||||
720961|NCT00316914|Secondary|Incidence of Calcium Magnesium (CaMg)-Induced Adverse Event|Adverse Events were measured using CTCAE V3.0.|127 days|Analyses of adverse events includes all patients. Adverse event data is not available on one patient in Placebo arm, which leads to the total of 51 in Placebo arm for analysis.||Percentage of Participants|||Number
720962|NCT00316914|Secondary|Percentage of Patients With Acute Neuropathic Adverse Event|Acute neuropathic toxicities were measured using the Symptom Experience Diary and supplemental quality of life questions in the scale of 0 (no symptom) to 10 (worst symptom). The item score was reversed and transformed into 0 (low QOL) to 100 (best QOL) scale for analysis. Any score greater than 0 was considered having acute neuropathy.|127 days|Includes all patients that reported at least one value after baseline.||Percentage of participants|||Number
720963|NCT00316914|Secondary|Average Duration of Oxaliplatin-containing Treatment||127 days|Because of the early closure of this trial, no reliable data were available for this outcome.|||||
720964|NCT00316914|Secondary|Average Cumulative Oxaliplatin Dose||127 days|Because of the early closure of this trial, no reliable data were available for this outcome.|||||
720965|NCT00316914|Secondary|Percentage of Patients Discontinuing Therapy for Chronic Neurotoxicity|Neurotoxicity were assessed by CTCAE v3.0.|127 days|Includes all patients that reported at least one value after baseline.||Percentage of Participants|||Number
720966|NCT00316914|Secondary|Average Duration of Chronic Neuropathic Toxicity|Neuropathic adverse events were assessed by CTCAE v3.0.|127 days|Includes all patients that reported at least one value after baseline.||days||95% Confidence Interval|Median
720967|NCT00316914|Secondary|Time to Onset of Grade 3+ Chronic Neurotoxicity|Neurotoxicity was assessed by CTCAE v3.0.|127 days|Includes all patients that reported at least one value after baseline.||Days||95% Confidence Interval|Median
720968|NCT00316914|Secondary|Time to Onset of Grade 2+ Chronic Neurotoxicity|Neurotoxicity were assessed by Common Terminology Criteria for Adverse Events (CTCAE) v3.0.|127 days|Includes all patients that reported at least one value after baseline.||Days||95% Confidence Interval|Median
720969|NCT00316914|Primary|Percentage of Patients With Oxaliplatin-induced Grade 2+ Chronic Neuropathic Adverse Event|Neuropathic adverse events were assessed by Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Neurotoxicity evaluation grade: loss of deep tendon reflexes or paresthesia, including tingling, but not interfering with function (Grade 1); objective sensory alteration or paresthesia, including tingling, interfering with function, but not with activities of daily living (Grade 2); sensory alteration or paresthesia interfering with activities of daily living (Grade 3); permanent sensory losses that are disabling (Grade 4)|127 days|Efficacy analyses use all patients that reported at least one value after baseline.||Percentage of participants|||Number
720970|NCT00317044|Secondary|Changes in Average Value From Baseline to Treatment Period in Number of Inhalations of Short-acting β2-agonists (SABAs) - Night|Participants must have both baseline and follow up measure to be included in analysis|Baseline to 6 months|||Inhalations||Standard Error|Least Squares Mean
720971|NCT00317044|Secondary|Changes in Average Value From Baseline to Treatment Period in Asthma Symptom Score - Day|Participants must have both baseline and follow up measure to be included in analysis|Baseline to 6 months|||Scores on a scale||Standard Error|Least Squares Mean
720972|NCT00317044|Secondary|Changes in Average Value From Baseline to Treatment Period in Asthma Symptom Score - Night|Participants must have both baseline and follow up measure to be included in analysis|Baseline to 6 months|||Scores on a scale||Standard Error|Least Squares Mean
720973|NCT00317044|Secondary|Number of Severe Adverse Events||Up to 6 months|||Events|||Number
720974|NCT00317044|Secondary|Change in Symptoms of GERD as Measured by Reflux Disease Questionnaire (RDQ) From Randomization (Visit 3) to Visit 7|The RDQ questionnaire is used to assess six GI symptoms during the previous week (a burning feeling behind the breastbone, pain behind the breastbone, a burning feeling in the centre of the stomach, pain in the centre of the stomach, an acid taste in the mouth, unpleasant movement of material upwards from the stomach). Each symptom is given a frequency score on a six-point scale (from 0=did not have to 5=daily) and an intensity score on a six-point scale (from 0=did not have to 5=severe). Three domain scores are calculated by forming averages of the frequency and intensity scores of selected symptoms (heartburn: the first two symptoms; dyspepsia: the next two symptoms; regurgitation: the last two symptoms). The overall GERD score is calculated as the average of the hearburn and dyspepsia domain scores. The GERD score can thus range from 0 to 5.|Randomization (Visit 3) to Visit 7|||Scores on a scale||Standard Error|Least Squares Mean
720977|NCT00317044|Secondary|Change in Forced Expiratory Volume in 1 Second (FEV1) From Randomization to Treatment Period.|Description: Changes in forced expiratory volume in 1 second (FEV1) from randomization (Visit 3) to the treatment period considered as mean value at Visits 4-7. Participants must have both baseline and follow up measure to be included in analysis.|From randomization (Visit 3) to visit 7.|||Liters||Standard Error|Least Squares Mean
720978|NCT00317044|Secondary|Changes in Average Value From Baseline to Treatment Period in Percentage of Nights With Awakening(s) Due to Asthma|Change in percentage of nights with night-time awakening(s) due to asthma from baseline to the end of the study (6 months). Participants must have both baseline and follow up measure to be included in analysis.|Baseline to 6 months|||Percent of nights||Standard Error|Least Squares Mean
720979|NCT00317044|Secondary|Changes in Average Value From Baseline to Treatment Period in Number of Inhalations of Short-acting β2-agonists (SABAs) - Total From Baseline to 6 Months|This is the change in the average number of inhalations from baseline to the end of the study (6 months). Participants must have both baseline and follow up measure to be included in analysis. Treatment mean calculated using the entire treatment period.|Baseline to 6 months|||Inhalations||Standard Error|Least Squares Mean
720980|NCT00317044|Secondary|Changes in Average Value From Baseline to Treatment Period in Asthma Symptom Score - Total|Participants must have both baseline and flow up measure to be included in analysis. Each morning and evening, the patient will be asked to record his/her asthma symptoms (sx) in the diary. The asthma sx scores during night- and daytime will be assessed by the patient according to the following scoring system: 0 = no asthma sx; 1 = you are aware of your asthma sx but can easily tolerate the sx; 2 = your asthma sx are causing you enough discomfort to cause problems with normal activities (or with sleep); 3 = you are unable to do your normal activities (or sleep) because of your asthma. The total symptom score is the sum of the night- and daytime scores.|Baseline to 6 months|||Scores on a scale||Standard Error|Least Squares Mean
720981|NCT00317044|Secondary|Changes in Average Value From Baseline to Treatment Period in Evening Peak Expiratory Flow (ePEF (L/Minute))|Peak expiratory flow is defined as the maximum speed of expiration as measured with the Mini-Wright® PEF Meter. Participants must have both baseline and follow up measure to be included in analysis. No dispersion measure available.|Baseline to 6 months|||L/minute||Standard Error|Least Squares Mean
720982|NCT00317044|Primary|Mean Change in Morning Peak Expiratory Flow (mPEF (L/Minute)) From Baseline (Mean of the Last 7 Days in the run-in Period) to Treatment Period (Mean of All Available Data During the Treatment Period).|Peak expiratory flow is defined as the maximum speed of expiration as measured with the Mini-Wright® PEF Meter. Participants must have both baseline and follow up measure to be included in analysis. Results presented as a mean of all available data during the treatment period.|Baseline to 6 months|||L/minute||Standard Error|Least Squares Mean
720983|NCT00317109|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Months 15-18 and up to Months 25-31 post vaccination|The analysis were performed on the Booster Total Vaccinated Cohort which included all subjects who received at least one of the two vaccines.||Subjects|||Number
720984|NCT00317109|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-Day (Days 0-30) after the administration of the Mencevax™ ACW vaccine|The analysis were performed on the Booster Total Vaccinated Cohort which included all subjects who received at least one of the two vaccines.||Subjects|||Number
720985|NCT00317109|Secondary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms were: drowsiness, fever, irritability and loss of appetite. Any = subjects with symptoms, regardless of intensity grade and casual relationship to study vaccination.|During the 4-Day (Days 0-3) after the administration of the Mencevax™ ACW vaccine|The analysis were performed on the Booster Total Vaccinated Cohort which included all subjects who received at least one of the two vaccines and had the symptoms sheet filled in.||Subjects|||Number
720986|NCT00317109|Secondary|Number of Subjects With Solicited Local Symtoms|Assessed solicited local symptoms were: pain, redness and swelling at the injection site. Any = subjects with symptom, regardless of the intensity grade.|During the 4-Day (Days 0-3) after the administration of the Mencevax™ ACW vaccine|The analysis was performed on the Booster Total Vaccinated Cohort which included all subjects who received at least one of the two vaccines and had the symptoms sheet filled in.||Subjects|||Number
720987|NCT00317109|Secondary|Number of Subjects With Fever|Any Fever (measured rectally) = subjects with symptom, regardless of the intensity grade.|During the 4-day (Days 0-3) after the administration of the Tritanrix™-HepB/Hiberix™ vaccine|The analysis was performed on the Booster Total Vaccinated Cohort which included all subjects who received at least one of the two vaccines.||Subjects|||Number
720988|NCT00317109|Secondary|Number of Subjects With Vaccine Response for rSBA-Men A, C and W-135|Vaccine response was defined as follows: for initially seronegative subjects (i.e. with rSBA titre < 1:8 pre-vaccination), rSBA titre ≥ 1:32 post-vaccination (seroconversion), and for initially seropositive subjects (i.e. with rSBA titre ≥ 1:8 pre-vaccination), at least a 4-fold increase in rSBA titre from pre to post-vaccination.|At one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)|The analysis were performed on the Booster ATP cohort for immunogenicity which included all evaluable subjects who received the 3 vaccine doses in the primary vaccination study, received one of the two vaccines according to the protocol in this booster study and for whom data concerning immunogenicity measures were available.||Subjects|||Number
720989|NCT00317109|Secondary|Anti-HBs Antibody Concentrations|Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs).|Prior to (Months 24-30) the administration of the Mencevax™ ACW vaccine|The analysis were performed on the Booster ATP cohort for immunogenicity which included all evaluable subjects who received the 3 vaccine doses in the primary vaccination study, received one of the two vaccines according to the protocol in this booster study and for whom data concerning immunogenicity measures were available.||mIU/mL||95% Confidence Interval|Geometric Mean
720990|NCT00317109|Secondary|Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations ≥ Predefined Cut-off Values|Antibody concentrations cut-off were ≥ 10 milli international units per milliliter (mIU/mL).|Prior to (Months 24-30) the administration of the Mencevax™ ACW vaccine|The analysis were performed on the Booster ATP cohort for immunogenicity which included all evaluable subjects who received the 3 vaccine doses in the primary vaccination study, received one of the two vaccines according to the protocol in this booster study and for whom data concerning immunogenicity measures were available.||Subjects|||Number
720991|NCT00317109|Secondary|Anti-PSW Antibody Concentrations|Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs).|Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)|The analysis were performed on the Booster ATP cohort for immunogenicity which included all evaluable subjects who received the 3 vaccine doses in the primary vaccination study, received one of the two vaccines according to the protocol in this booster study and for whom data concerning immunogenicity measures were available.||µg/mL||95% Confidence Interval|Geometric Mean
720992|NCT00317109|Secondary|Number of Subjects With Anti- Polysaccharide W (Anti-PSW) Antibody Concentrations ≥ Predefined Cut-off Values|Antibody concentrations were ≥ 0.3 µg/mL.|Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)|The analysis were performed on the Booster ATP cohort for immunogenicity which included all evaluable subjects who received the 3 vaccine doses in the primary vaccination study, received one of the two vaccines according to the protocol in this booster study and for whom data concerning immunogenicity measures were available.||Subjects|||Number
720993|NCT00317109|Secondary|Anti-PSA and Anti-PSC Antibody Concentrations|Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs).|Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31|The analysis were performed on the Booster ATP cohort for immunogenicity which included all evaluable subjects who received the 3 vaccine doses in the primary vaccination study, received one of the two vaccines according to the protocol in this booster study and for whom data concerning immunogenicity measures were available.||µg/mL||95% Confidence Interval|Geometric Mean
720994|NCT00317109|Secondary|Number of Subjects With Anti-polysaccharide A (Anti-PSA) and C (Anti-PSC) Antibody Concentrations Above Predefined Cut-off Values|Antibody concentrations cut-off were ≥ 0.3 and ≥2 micrograms per millilitre (µg/mL).|Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)|The analysis were performed on the Booster ATP cohort for immunogenicity which included all evaluable subjects who received the 3 vaccine doses in the primary vaccination study, received one of the two vaccines according to the protocol in this booster study and for whom data concerning immunogenicity measures were available.||Subjects|||Number
720995|NCT00317109|Secondary|Anti-rSBA-MenA, C, W-135 Antibody Titers|Antibody titers were expressed as geometric mean titers (GMTs).|Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)|The analysis were performed on the Booster ATP cohort for immunogenicity which included all evaluable subjects who received the 3 vaccine doses in the primary vaccination study, received one of the two vaccines according to the protocol in this booster study and for whom data concerning immunogenicity measures were available.||Titers||95% Confidence Interval|Geometric Mean
720996|NCT00317109|Secondary|Number of Subjects With rSBA-MenA,C, W-135 Antibody Titers ≥ Predefined Cut-offs|Antibody titer cut-offs were ≥ 1:8 and ≥ 1:128.|Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)|The analysis were performed on the Booster ATP cohort for immunogenicity which included all evaluable subjects who received the 3 vaccine doses in the primary vaccination study, received one of the two vaccines according to the protocol in this booster study and for whom data concerning immunogenicity measures were available.||Subjects|||Number
720997|NCT00317109|Primary|Number of Subjects With Serum Bactericidal Assay Against N. Meningitidis Serogroups A, C Using Rabbit Complement (rSBA-MenA,C) Antibodies|Pre-defined assay cut-off values for assessed titers were greater than or equal to (≥) 1:128.|At one month post vaccination with Mencevax™ ACW vaccine (Month 25-31)|The analysis were performed on the Booster ATP cohort for immunogenicity which included all evaluable subjects who received the 3 vaccine doses in the primary vaccination study, received one of the two vaccines according to the protocol in this booster study and for whom data concerning immunogenicity measures were available.||Subjects|||Number
720998|NCT00317226|Primary|Incidence of Treatment-emergent Adverse Events||44 week study duration|||each event|||Number
720999|NCT00317239|Primary|Number of Subjects Achieving an Increase in Hemoglobin ≥1g/dL||anytime during the study|Modified Intent to Treat (mITT) population defined as subjects who received at least 1 dose of study medication, had stable EPO for at least 8 weeks prior to randomization, had at least 1 post-baseline hemoglobin assessment, and who had NDD-CKD characterized by a GFR ≤45 mL/min/1.73²||participants|||Number
721000|NCT00317473|Secondary|Anti-FMP1 Antibody Titer Responses|Antibody responses to FMP1 by ELISA following immunization with the study vaccine through 364 days following the first dose of study vaccine|364 days|||titers||95% Confidence Interval|Geometric Mean
721001|NCT00317473|Primary|Occurrence of Serious Adverse Events During an 8 Month Follow-up Period Following the First Dose of Study Vaccine|Occurrence of solicited and unsolicited serious adverse events during an 8 month follow-up period following the first dose of study vaccine|8 months|||events|||Number
721002|NCT00317473|Primary|Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination|Occurrence of unsolicited symptoms during a 30 day follow-up period after each vaccination (day of vaccination and the 29 subsequent days)|90 days|||events|||Number
721003|NCT00317473|Primary|Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination|Occurrence of any, local, or general solicited symptoms during the 8 day follow-up period|40 days|||events|||Number
721004|NCT00317642|Secondary|Participants With Adverse Events (CSR 7-April-11)|"Number of participants with treatment emergent adverse events (TEAEs) or death due to related AE. Related AEs for the combination arm can be related to either clofarabine or cytarabine.
Grade 1 = Mild AE, Grade 2 = Moderate AE, Grade 3 = Severe AE, Grade 4 = Life Threatening AE, Grade 5 = Death"|Day 1 up to a maximum of 4 years (includes up to a maximum of 3 cycles of therapy plus 45 days follow up. Related AEs are followed to resolution.)|Safety Set - Participants in the Full Analysis Set (FAS) who received at least 1 dose of study drug.||participants|||Number
721054|NCT00318409|Primary|Feasibility: Proportion of Scheduled Study Visits Completed||12 weeks|||Scheduled study visits completed|Participants||Number
721005|NCT00317642|Secondary|Four-Month Event-free Survival Per IRRP Assessment – Overall and by Randomized Strata (CSR 9-July-12)|"Four-month event-free survival (EFS) was defined as achieving an EFS of at least 122 days, where EFS is defined as the time from randomization to the date of treatment failure, first disease recurrence (for participants who achieved remission), or death due to any cause, whichever occurred first.
Treatment Failure - ≥5% leukemic blasts by bone marrow exam, with no evidence of hematologic response (ie, <30% decrease in % leukemic blasts).
Disease recurrence - reappearance of leukemic blasts in the peripheral blood, confirmed by ≥5% blasts in the bone marrow, and reappearance or development of pathologically proven extramedullary disease."|Day 1 (randomization) to Day 122|Full Analysis Set - composed of all randomized participants whose baseline AML diagnosis was centrally confirmed. Strata are as randomized by the IVRS, that is the strata include the IVRS mistakes.||percentage of participants|||Number
721006|NCT00317642|Secondary|Four-Month Event-free Survival Per IRRP Assessment – Overall and by Calculated Strata (CSR 7-April-11)|"Four-month event-free survival (EFS) was defined as achieving an EFS of at least 122 days, where EFS is defined as the time from randomization to the date of treatment failure, first disease recurrence (for participants who achieved remission), or death due to any cause, whichever occurred first.
Treatment Failure - ≥5% leukemic blasts by bone marrow exam, with no evidence of hematologic response (ie, <30% decrease in % leukemic blasts).
Disease recurrence - reappearance of leukemic blasts in the peripheral blood, confirmed by ≥5% blasts in the bone marrow, and reappearance or development of pathologically proven extramedullary disease."|Day 1 (randomization) to Day 122|Full Analysis Set (FAS)-all randomized participants whose baseline AML diagnosis was centrally confirmed. Strata are calculated according to duration of the first remission based on case report forms (CRF) data and do not include the IVRS mistakes. One participant's strata (placebo group) could not be calculated so the participant was excluded.||percentage of participants|||Number
721007|NCT00317642|Secondary|Event-free Survival by IRRP Assessment – Overall and by Randomized Strata (CSR 9-July-12)|"Event-free survival (EFS) was defined as the time from randomization to the date of treatment failure, first disease recurrence (for participants who achieved remission), or death due to any cause, whichever occurred first.
Treatment Failure - ≥5% leukemic blasts by bone marrow exam, with no evidence of hematologic response (ie, <30% decrease in % leukemic blasts).
Disease recurrence - reappearance of leukemic blasts in the peripheral blood, confirmed by ≥5% blasts in the bone marrow, and reappearance or development of pathologically proven extramedullary disease."|Day 1 (randomization) up to approximately 4 years|Full Analysis Set - composed of all randomized participants whose baseline AML diagnosis was centrally confirmed. Strata are as randomized by the IVRS, therefore strata include the IVRS mistakes.||months||95% Confidence Interval|Median
721008|NCT00317642|Primary|Overall Survival - Overall and by Randomized Strata (CSR 9-July-12)|Overall survival (OS) for the Full Analysis Set (FAS) and for the 2 randomized strata. OS was defined as the number of months from date of randomization until date of death due to any cause.|Day 1 (randomization) up to approximately 4 years|Full Analysis Set (FAS) - composed of all randomized participants whose baseline AML diagnosis was centrally confirmed. Strata are as randomized by the IVRS, therefore strata include the IVRS mistakes.||months||95% Confidence Interval|Median
721009|NCT00317642|Secondary|Event-free Survival by IRRP Assessment – Overall and by Calculated Strata (CSR 7-April-11)|"Event-free survival (EFS) was defined as the time from randomization to the date of treatment failure, first disease recurrence (for participants who achieved remission), or death due to any cause, whichever occurred first.
Treatment Failure - ≥5% leukemic blasts by bone marrow exam, with no evidence of hematologic response (ie, <30% decrease in % leukemic blasts).
Disease recurrence - reappearance of leukemic blasts in the peripheral blood, confirmed by ≥5% blasts in the bone marrow, and reappearance or development of pathologically proven extramedullary disease."|Day 1 (randomization) up to approximately 4 years|Full Analysis Set (FAS)-all randomized participants whose baseline AML diagnosis was centrally confirmed. Strata are calculated according to duration of the first remission based on case report forms (CRF) data and do not include the IVRS mistakes. One participant's strata (placebo group) could not be calculated so the participant was excluded.||months||95% Confidence Interval|Median
721010|NCT00317642|Secondary|Disease-free Survival by IRRP Assessment - Overall and by Randomized Strata (CSR 9-July-12)|"Disease-free survival was defined as the time from first complete remission (CR) or complete remission with incomplete peripheral blood count recovery (CRi) until the date of first objective documentation of disease recurrence or death due to any cause, whichever occurred first.
See Outcome #3 for definition of CR and CRi.
Disease recurrence - reappearance of leukemic blasts in the peripheral blood, confirmed by ≥5% blasts in the bone marrow, and reappearance or development of pathologically proven extramedullary disease."|Day 12 to approximately 4 years|Participants in the FAS who achieved OR (CR + CRi). Strata are as randomized by the IVRS, therefore strata include the IVRS mistakes.||months||95% Confidence Interval|Median
721011|NCT00317642|Secondary|Disease-free Survival by IRRP Assessment - Overall and by Calculated Strata (CSR 7-April-11)|"Disease-free survival was defined as the time from first complete remission (CR) or complete remission with incomplete peripheral blood count recovery (CRi) until the date of first objective documentation of disease recurrence or death due to any cause, whichever occurred first.
See Outcome #3 for definition of CR and CRi.
Disease recurrence - reappearance of leukemic blasts in the peripheral blood, confirmed by ≥5% blasts in the bone marrow, and reappearance or development of pathologically proven extramedullary disease."|Day 12 to approximately 4 years|Participants in the FAS who achieved OR (CR + CRi). Strata are calculated according to duration of the first remission based on case report forms (CRF) data and do not include the IVRS mistakes.||months||95% Confidence Interval|Median
721027|NCT00317941|Secondary|Percentage of Sites Developing a Severe Reaction 48 Hours After Injection|An ISR is considered as severe if the score reported by the patient is above 2 (at least one red skin) 0- no abnormal reaction, 1- erythema, 2-edema, 3- infiltration 4- ulceration or necrosis|Up to 3 months assessed every 48 hours after each injection|||Percentage of sites|Participants||Number
721028|NCT00317941|Secondary|Percentage of Sites Developing a Severe Reaction 24 Hours After Injection|An ISR is considered as severe if the score reported by the patient is above 2 (at least one red skin) 0- no abnormal reaction, 1- erythema, 2-edema, 3- infiltration 4- ulceration or necrosis|Up to 3 months assessed every 24 hours after each injection|||Percentage of sites|Participants||Number
721029|NCT00317941|Secondary|Percentage of Participants Without ISR Reported by Participants||Up to 3 months assessed every 24 hours after each injection|||Percentage of participants|||Number
721012|NCT00317642|Secondary|Duration of Remission (DOR) Per IRRP Assessment-Overall and by Randomized Strata (CSR 9-July-12)|"DOR was defined as the time from first CR or CRi to the date of first objective documentation of disease recurrence, initiation of alternative antileukemic therapy [including hematopoietic stem cell transplant] while in remission, or death due to any cause, whichever occurred first.
CR is defined on morphologic criteria at a single response assessment:
a bone marrow aspirate or biopsy of <5% blasts, with evidence of normal hematopoiesis;
absence of Auer rods in the blasts that are present;
absence of extramedullary disease;
absence of a unique phenotype determined at the pretreatment specimen, as assessed by immunophenotyping;
only rare evidence of circulating blasts. If present, evidence of a regenerating bone marrow;
recovery of peripheral counts (platelets ≥100*10^9/L and absolute neutrophil count (ANC) ≥1.0*10^9/L).
CRi met all criteria for CR except for either residual neutropenia (ANC <1.0*10^9/L) or thrombocytopenia (platelet count <100*10^9/L)."|Day 12 to approximately 4 years|Participants in the FAS who achieved OR (CR + CRi). Strata are as randomized by the IVRS, therefore strata include the IVRS mistakes.||months||95% Confidence Interval|Median
721013|NCT00317642|Secondary|Duration of Remission (DOR) Per IRRP Assessment-Overall and by Calculated Strata (CSR 7-April-11)|"DOR was defined as the time from first CR or CRi to the date of first objective documentation of disease recurrence, initiation of alternative antileukemic therapy [including hematopoietic stem cell transplant] while in remission, or death due to any cause, whichever occurred first.
CR is defined on morphologic criteria at a single response assessment:
a bone marrow aspirate or biopsy of <5% blasts, with evidence of normal hematopoiesis;
absence of Auer rods in the blasts that are present;
absence of extramedullary disease;
absence of a unique phenotype determined at the pretreatment specimen, as assessed by immunophenotyping;
only rare evidence of circulating blasts. If present, evidence of a regenerating bone marrow;
recovery of peripheral counts (platelets ≥100*10^9/L and absolute neutrophil count (ANC) ≥1.0*10^9/L).
CRi met all criteria for CR except for either residual neutropenia (ANC <1.0*10^9/L) or thrombocytopenia (platelet count <100*10^9/L)."|Day 12 to approximately 4 years|Participants in the FAS who achieved OR (CR + CRi). Strata are calculated according to duration of the first remission based on case report forms (CRF) data and do not include the IVRS mistakes.||months||95% Confidence Interval|Median
721014|NCT00317642|Secondary|Best Response Per Independent Response Review Panel (IRRP) Assessment – Overall and by Calculated Strata (CSR 7-April-11)|"Percentage of participants whose best response was assessed by the IRRP as complete remission (CR) or complete remission with incomplete peripheral blood count recovery (CRi) using the revised International Working Group for Response Criteria (Cheson 2003).
CR is defined on morphologic criteria at a single response assessment:
a bone marrow aspirate or biopsy of <5% blasts, with evidence of normal hematopoiesis;
absence of Auer rods in the blasts that are present;
absence of extramedullary disease;
absence of a unique phenotype determined at the pretreatment specimen, as assessed by immunophenotyping;
only rare evidence of circulating blasts. If present, evidence of a regenerating bone marrow;
recovery of peripheral counts (platelets ≥100*10^9/L and absolute neutrophil count (ANC) ≥1.0*10^9/L).
CRi met all criteria for CR except for either residual neutropenia (ANC <1.0*10^9/L) or thrombocytopenia (platelet count <100*10^9/L)."|Day 12 up to approximately 6 months|Full Analysis Set (FAS)-all randomized participants whose baseline AML diagnosis was centrally confirmed. Strata are calculated according to duration of the first remission based on case report forms (CRF) data and do not include the IVRS mistakes. One participant's strata (placebo group) could not be calculated so the participant was excluded.||percentage of participants|||Number
721015|NCT00317642|Primary|Overall Survival – Overall and by Calculated Strata (CSR 7-April-11)|Overall survival (OS) for the Full Analysis Set (FAS) and for the 2 calculated strata. OS was defined as the number of months from date of randomization until date of death due to any cause.|Day 1 (randomization) up to approximately 4 years|Full Analysis Set (FAS)-all randomized participants whose baseline AML diagnosis was centrally confirmed. Strata are calculated according to duration of the first remission based on case report forms (CRF) data and do not include the IVRS mistakes. One participant's strata (placebo group) could not be calculated so the participant was excluded.||months||95% Confidence Interval|Median
721016|NCT00317720|Primary|Clinical Benefit Response Rate (CBR)|Efficacy measured by the clinical benefit response rate (CBR), defined as confirmed Complete Response (CR) plus Partial Response (PR) at any time plus Persistent Stable Disease (pSD). Confirmed CR is defined as disappearance of all target lesions at the time of radiographic evaluation; pSD was defined as SD lasting 24 weeks. Complete Response (CR): disappearance of all target lesions, and Partial Response (PR): at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as a reference the baseline sum LD. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as references the smallest sum LD since the treatment started.|6 weeks|||percentage of partcipants|||Number
721017|NCT00317720|Primary|Optimal Dose of RAD001 in Combination With Trastuzumab (Phase I)|"In Phase I, two dose levels of RAD001 were studied: 10 mg (dose level 1) and 5 mg (dose level -1) where each dose was evaluated after cycle 1. At MDACC, the Continual Reassessment Method (CRM) for determining Maximum Tolerated Dose (MTD) was applied to the two predefined RAD001 dose levels; and at DFCI/BIDMC, a 3 x 3 study design was utilized.
Optimal dose defined as the dose most closely associated with a toxicity rate of 0.20, and toxicity defined as any grade 3 or 4 toxicity (based on Common Terminology Criteria (CTC) version 3.0 except fatigue. Participants underwent clinical evaluation every 3 weeks (one cycle) and radiologic evaluations every 6 weeks. After the second cycle, participants underwent a radiologic evaluation using the same imaging technique used at initial evaluation (ie, computed tomography or magnetic resonance imaging)."|Following two 3 week cycles of therapy|At MDACC, sixteen participants total treated at 10 mg (dose level 1) in the Phase I portion of the study with the remainder thirty-four registered in Phase II. At DFCI/BIDMC, the first three participants were included in the Phase I portion of the study, the remaining four of seven registered were in Phase II.||mg|||Number
721018|NCT00317941|Secondary|Percentage of Sites Without Reaction 48 Hours After Injection Reported by Participants|"if the patient score is missing, at the injection site, then the patient is not considered without or with developping reaction.
An injection site is seen as developing no reaction if the patient’s score for this site is of a reaction intensity = 0."|Up to 3 months assessed every 48 hours after each injection|||Percentage of sites|Participants||Number
721019|NCT00317941|Secondary|Percentage of Sites Without Reaction 24 Hours After Injection Reported by Participants||Up to 3 months assessed every 24 hours after each injection|||Percentage of sites|Participants||Number
721034|NCT00317941|Primary|Percentage of Sites Developing a Injection Site Reaction (ISR) Reported by Participants 48 Hours After Each Injection|An injection site is seen as developing a reaction if the patient’s score for this site is of a reaction intensity ≥ 1. Number of injection sites per month per participant analyzed|Up to 3 months assessed every 48 hours after each injection|||Percentage of sites|Participants||Number
721035|NCT00317941|Primary|Percentage of the Sites Developing a Injection Site Reaction (ISR) Reported by Participants 24 Hours After Each Injection|An injection site is seen as developing a reaction if the patient’s score for this site is of a reaction intensity ≥ 1. Number of injection sites per month per participant analyzed|Up to 3 months assessed every 24 hours after each injection|||Percentage of sites|Participants||Number
721036|NCT00318136|Secondary|Progression-free Survival|"Progression−free survival (PFS) was defined as the time from enrollment to the time of documented disease progression or death from any cause, whichever occurred earlier. PFS was determined for only those patients that received bevacizumab.
Summary of PFS (median) was estimated from Kaplan−Meier curve. The 95% confidence interval (CI) for the median was computed using the method of Brookmeyer and Crowley."|Length of study|Enrolled patients||Months||95% Confidence Interval|Median
721037|NCT00318136|Secondary|Adverse Events That Led to Discontinuation of Bevacizumab|Any treatment-emergent adverse event leading to study treatment discontinuation|First bevacizumab administration until 60 days after discontinuation of bevacizumab or death|Safety-evaluable patients||Patients|||Number
721038|NCT00318136|Secondary|Selected Adverse Events|"Selected treatment-emergent adverse events for any grade of pulmonary hemorrhage, any grade of non-pulmonary hemorrhage, any grade of gastrointestinal perforation, Grade ≥ 2 arterial thromboembolic events, Grade ≥ 2 left ventricular systolic dysfunction, Grade ≥ 3 proteinuria, and Grade ≥ 3 hypertension. Refer to NCI CTCAE v.3 for grading definitions.
Serious adverse events (SAEs) occurring in any of the above categories are included. See the Serious Adverse Events section below for full SAE reporting."|First bevacizumab administration until 60 days after discontinuation of bevacizumab or death|Safety-evaluable patients||Patients|||Number
721039|NCT00318136|Primary|Incidence of Grade ≥3 Pulmonary Hemorrhage Adverse Events|"To estimate the rate of National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE), Version 3.0, Grade ≥3 pulmonary hemorrhage adverse events. Per NCI CTCAE v.3: Grade 3 = Transfusion, interventional radiology, endoscopic, or operative intervention indicated; radiation therapy (i.e., hemostasis of bleeding site); Grade 4 = Life-threatening consequences; major urgent intervention indicated; Grade 5 = Death."|First bevacizumab administration until 60 days after discontinuation of bevacizumab or death|Safety-evaluable patients||Percentage of patients|||Number
721040|NCT00318292|Primary|Visual Analogue Scale (VAS) Pain Score|Visual Analogue Scale (VAS) pain score on a scale from 0 (None) to 10 (Worst) points.|30 minutes post-op|||points on a scale||Standard Deviation|Mean
721041|NCT00318370|Secondary|Percentage of Participants Who Had a Prolongation of Remission|Percentage of participants whose second remission was longer than their first remission. The length of remission will be determined for participants who attain CR or PR (or SD and investigator’s assessment of clinical benefit). Prolongation of remission will be defined as a length of remission occurring on this study that is ≥ 1 day longer than the length of remission to the original therapy. The length of remission on this study (second remission) will be defined as the amount of time from the date of first CR or PR to the end of this remission.|Baseline to response (up to 44 months)|All participants who received chemotherapy plus farletuzumab as well as those who continued on maintenance farletuzumab.||percentage of participants||95% Confidence Interval|Number
721042|NCT00318370|Secondary|Progression-free Survival (PFS)|PFS is defined for participants treated in Chemo Plus Far as the time (in months) from date of first dose in Chemo Plus Far until date of the first observation of progression based on first date of the CA-125 >2 X ULN on two occasions, or date of death, whatever the cause. If progression or death is not observed for a participant, the PFS time is censored at the later date of last tumor assessment or CA125 assessment without evidence of progression prior to the date of initiation of further anti-tumor treatment.|Baseline to response (up to 44 months)|All participants who received chemotherapy plus farletuzumab as well as those who continued on maintenance farletuzumab.||Months||95% Confidence Interval|Median
721043|NCT00318370|Secondary|Overall Response Rate|The Overall Response Rate (ORR) will be determined by applying standard RECIST criteria to objective measures of disease, such as CT or MRI scans. Participants will be assigned to one of the categories of change in disease status, namely, “complete response” (CR), “partial response” (PR), “stable disease” (SD), or “progressive disease” (PD). ORR is defined as the percentage of participants with objective evidence of CR or PR.|Baseline to response (up to 44 months)|||percentage of participants|||Number
721044|NCT00318370|Secondary|Duration of Serologic Response (CA-125)|Calculated as the time from the first documentation of 50% or greater reduction in CA-125 to the first documentation of serologic progression or death due to any cause. Serologic progression was defined as the first date of the CA-125 level being >2 X ULN on two occasions.|Baseline to response (up to 44 months)|All participants enrolled to initial chemotherapy plus farletuzumab.||Months||95% Confidence Interval|Median
721045|NCT00318370|Secondary|Time to Serologic Response (Change in CA-125 Level)|Time to Serologic Response is defined as the time (weeks) from the date of first farletuzumab infusion to first documentation of 50% decrease from baseline CA-125 (higher of 2 pretreatment CA-125 assessments and at least twice the upper limit of normal) and then confirmed after 21 days.|Baseline to response (up to 27 weeks)|All participants enrolled to intial chemotherapy plus farletuzumab.||Weeks||95% Confidence Interval|Median
721046|NCT00318370|Primary|Serologic Response (Change in Cancer Antigen [CA-125] Level)|Defined using modified Gynecologic Cancer Intergroup (GCIG) criteria: Number of participants who had a 50% response = >50% decrease from baseline CA-125 (higher of 2 pretreatment CA-125 assessments and the level must be at least 52.5 kU/L).|Baseline to response (up to 27 weeks)|All participants enrolled to chemotherapy plus farletuzumab.||participants|||Number
721047|NCT00318370|Primary|Serologic Response (Change in CA125 Level)|Defined using modified Gynecologic Cancer Intergroup (GCIG) criteria: Number of participants who achieved a 50% response = >50% decrease from baseline CA-125 (higher of 2 pretreatment CA-125 assessments and the level must be at least 52.5 kU/L).|Baseline to response (up to 30 weeks)|All participants enrolled to initial farletuzumab only.||participants||95% Confidence Interval|Number
721055|NCT00318409|Primary|Feasibility: Proportion of Persons Screened Who Are Eligible and Enrolled||At Enrollment|||Eligible persons screened who enrolled|||Number
721056|NCT00318461|Secondary|Hypoglycaemic Episodes at Week 104|Total number of hypoglycaemic episodes occuring after baseline (week 0) until 104 weeks (end of treatment). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|weeks 0-104|Safety analysis set is all randomised subjects who were exposed to at least one dose of study product.||episodes|||Number
721057|NCT00318461|Secondary|Hypoglycaemic Episodes at Week 26|Total number of hypoglycaemic episodes occuring after baseline (week 0) until week 26 (end of randomisation). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|weeks 0-26|Safety analysis set is all randomised subjects who were exposed to at least one dose of study product.||episodes|||Number
721058|NCT00318461|Secondary|Change in Beta-cell Function at Week 104|"Change in beta cell function from baseline (week 0) to 16 weeks (end of treatment). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B).
Beta-cell function: HOMA-B (%) = 20∙fasting insulin[uU/mL] divided by (FPG mmol/L]-3.5)."|week 0, week 104|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.||percentage point (%point)||Standard Error|Least Squares Mean
721059|NCT00318461|Secondary|Change in Beta-cell Function at Week 26|"Change in beta cell function from baseline (week 0) to 16 weeks (end of treatment). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B).
Beta-cell function: HOMA-B (%) = 20∙fasting insulin[uU/mL] divided by (FPG mmol/L]-3.5)."|week 0, week 26|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.||percentage point (%point)||Standard Error|Least Squares Mean
721060|NCT00318461|Secondary|Change in Mean Post Prandial Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 104|Change in mean post prandial plasma glucose from baseline (Week 0) to 104 weeks (end of treatment) The 7 time points for self-measurements were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime. Mean post prandial plasma glucose were calculated as the sum of the post pradial plasma glucose values divided by three.|week 0, week 104|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.||mmol/L||Standard Error|Least Squares Mean
721061|NCT00318461|Secondary|Change in Mean Post Prandial Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 26|Change in mean post prandial plasma glucose from baseline (Week 0) to 26 weeks (end of randomisation). The 7 time points for self-measurements were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime. Mean post prandial plasma glucose were calculated as the sum of the post pradial plasma glucose values divided by three.|week 0, week 26|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.||mmol/L||Standard Error|Least Squares Mean
721062|NCT00318461|Secondary|Change in Mean Prandial Increments of Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 104|"Change in mean prandial increments of plasma glucose based on self-measured 7-point plasma glucose profiles from baseline (week 0) to 104 weeks (end of treatment). The 7 time points for self-measurements were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime.
Mean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between values measured before and after a meal (breakfast, lunch and dinner) divided by three."|week 0, week 104|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.||mmol/L||Standard Error|Least Squares Mean
721063|NCT00318461|Primary|Change in Glycosylated A1c (HbA1c) at Week 104|Change in glycosylated A1c (HbA1c) baseline (week 0) to 104 weeks (end of randomisation)|week 0, week 104|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.||percentage of total haemoglobin||Standard Error|Least Squares Mean
721064|NCT00318461|Secondary|Change in Mean Prandial Increments of Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 26|"Change in mean prandial increments of plasma glucose based on self-measured 7-point plasma glucose profiles from baseline (week 0) to 26 weeks (end of randomisation). The 7 time points for self-measurements were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime.
Mean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between values measured before and after a meal (breakfast, lunch and dinner) divided by three."|week 0, week 26|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.||mmol/l||Standard Error|Least Squares Mean
721065|NCT00318461|Secondary|Change in Fasting Plasma Glucose (FPG) at Week 104|Change in Fasting plasma glucose (FPG) from baseline (week 0) to 104 weeks (end of treatment)|week 0, week 104|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.||mmol/L||Standard Error|Least Squares Mean
721066|NCT00318461|Secondary|Change in Fasting Plasma Glucose (FPG) at Week 26|Change in fasting plasma glucose (FPG) from baseline (week 0) to 26 weeks (end of randomisation)|week 0, week 26|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.||mmol/L||Standard Error|Least Squares Mean
721067|NCT00318461|Secondary|Change in Body Weight at Week 104|Change in body weight from baseline (week 0) to 104 weeks (end of treatment)|week 0, week 104|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.||kg||Standard Error|Least Squares Mean
721068|NCT00318461|Secondary|Change in Body Weight at Week 26|Change in body weight from baseline (week 0) to 26 weeks (end of randomisation)|week 0, week 26|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.||kg||Standard Error|Least Squares Mean
721069|NCT00318461|Primary|Change in Glycosylated A1c (HbA1c) at Week 26|Percentage point change in Glycosylated A1c (HbA1c) from baseline (week 0) to 26 weeks (end of randomisation)|week 0, week 26|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.||Percentage point of total HbA1c||Standard Error|Least Squares Mean
721070|NCT00318474|Secondary|Change in Estimated Glomerular Filtration Rate (GFR) to Less Than 60% of the Baseline Level||12 months||||||
721071|NCT00318474|Primary|Change in Proteinuria - Uprotein/Creatinine Ratio|Urine protein/creatinine ratio after 6 months treatment with MMF or placebo.|Plan was to measure uprotein/creatinine ratio for 12 months on MMF or placebo, and then 12 months post-treatment. Data given after 6 months MMF/placebo.|||ratio||Standard Deviation|Mean
721072|NCT00318565|Primary|Percentage of Subjects Experiencing Cardiovascular Specific Adverse Events (CSAE) Within Seven (7) Days of the Ablation Procedure.|The cardiovascular specific adverse event (CSAE) rate is the primary safety enpoint for the study. A CSAE is an event which occurs within the first week (7 days) following use of the device and is one of the following cardiac specific adverse events: cardiac perforation, pericardial effusion, pulmonary embolus, complete heart block, stroke, acute myocardial infarction, and death.|7 Days|||percentage of participants||95% Confidence Interval|Mean
721073|NCT00318565|Primary|Percentage of Subjects With Complete Bidirectional Conduction Block.|Acute success is defined as the confirmation of complete bidirectional conduction block across the subeustachian (cavo-tricuspid) isthmus. The percentage of subjects with confirmed conduction block will serve as the outcome measure.|During the procedure|"Per protocol analysis. Number differs from Participant Flow because only 253 subjects were considered for the efficacy cohort."||percentage of participants||95% Confidence Interval|Mean
721074|NCT00318591|Secondary|Number of Participants With One or More Urinary Tract Infection||4-6 months|||participants|||Number
721075|NCT00318591|Secondary|Device-related or Possibly Device-related AEs||4-6 months|||Events|||Number
721076|NCT00318591|Secondary|Nurse Time Spent on Catheterization Procedure||4-6 months|ITT-population||seconds||Standard Deviation|Mean
721077|NCT00318591|Secondary|Patient or Caregiver's Evaluation of Catheters - Overall Satisfaction|Evaluation score on an 11-point scale from 0-10 (0 being lowest satisfaction)|4-6 months|ITT population||scores on a scale||Standard Deviation|Mean
721078|NCT00318591|Secondary|Nurse Evaluation of Catheters - Overall Satisfaction|Evaluation score on an 11-point scale from 0-10 (0 being lowest satisfaction)|4-6 months|Analysis were done on evaluations of the ITT-population. Evaluations were made at discharge from hospital. Since some participants discontinued the study prior to discharge and since some did not fill in the evaluation form, the total number of evaluations (132) do not add up to the total of the ITT population (219)||scores on a scale||Standard Deviation|Mean
721079|NCT00318591|Secondary|UTIs With Bacteriuria >=100 Colony Forming Units (CFU)/ml|UTIs with bacteriuria >=100 Colony Forming Units (CFU)/ml. Descriptive analysis|4-6 months|Descriptive only||UTI|||Number
721080|NCT00318591|Primary|Occurrence of Symptomatic Urinary Tract Infections (UTIs)|Occurrence of symptomatic urinary tract infections (UTIs). Time to first UTI|4-6 months|ITT-population, symptomatic urinary tract infections treated with antibiotics||participants|||Number
721081|NCT00318656|Secondary|Glycaemia According to CGMS (MAGE), mg/dL|Calculation of the Mean amplitude of glycemic excursion (MAGE) was obtained by measuring the arithmetic mean of the major glucose concentration increases or decreases on days 2 and 3 of glycaemic profile and then averaging results on the two days.|Baseline and 12 weeks|ITT (randomized)||mg/dL||Standard Error|Mean
721082|NCT00318656|Secondary|Glycaemia According to CGMS (Basal Incremental AUC or Values Above 1 mg/dL), mg/dL|Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations. The concentrations of glucose will be assessed from the AUC calculations on glycaemic values measured by CGM system.|Baseline and 12 weeks|ITT (randomized)||mg/dL||Standard Error|Mean
721083|NCT00318656|Secondary|Glycaemia According to CGMS (Postprandial Incremental AUC or Values Above 1 mg/dL), mg/dL|Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations. The concentrations of glucose will be assessed from the AUC calculations on glycaemic values measured by CGM system.|Baseline and 12 weeks|ITT (randomized)||mg/dL||Standard Error|Mean
721084|NCT00318656|Secondary|Glycaemia According to CGMS (Total Area Under the Curve (AUC) for Values Above 1 mg/dL), mg/dL|Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations. The concentrations of glucose will be assessed from the AUC calculations on glycaemic values measured by CGM system.|Baseline and 12 weeks|ITT (randomized)||mg/dL||Standard Error|Mean
721085|NCT00318656|Secondary|Glycaemia According to CGMS (Dawn), mg/dL|Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.The glycemia “at dawn” measured by CGM system will be defined as the average of glycemic values recorded between 4 AM and breakfast time.|Baseline and 12 weeks|ITT (randomized)||mg/dL||Standard Error|Mean
721086|NCT00318656|Secondary|Glycaemia According to CGMS (Diurnal), mg/dL|Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.The diurnal glycemia measured by CGM system will be the average of glycemic values recorded between breakfast time and midnight.|Baseline and 12 weeks|ITT (randomized)||mg/dL||Standard Error|Mean
721087|NCT00318656|Secondary|Glycaemia According to CGMS (Nocturnal), mg/dL|Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.The nocturnal glycemia measured by CGM system will be defined as the average of glycemic values collected between midnight and breakfast time.|Baseline and 12 weeks|ITT (randomized)||mg/dL||Standard Error|Mean
721088|NCT00318656|Secondary|8-Iso Prostaglandin F2α (8-iso PGF2α) Excretion Rate|8-Iso Prostaglandin F2α (8-iso PGF2α) excretion rate measured during the 24 hours preceding the CGM system removal. The nocturnal glycemia measured by CGM system will be defined as the average of glycemic values collected between midnight and breakfast time.|Baseline and 12 weeks|ITT (randomized)||pg/mL||Standard Error|Mean
721089|NCT00318656|Secondary|HbA1c (Glycosylated Hemoglobin)|Uncontrolled HbA1c>8.5%. HbA1c and fasting blood glucose taken at hospital|Baseline and 12 weeks|ITT (randomized)||Percentage||Standard Error|Mean
721090|NCT00318656|Secondary|Episodes of Hypoglycaemia (<60 mg/dL) at Baseline Compared to After 12 Weeks on Treatment|Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.|Baseline and 12 weeks|ITT (randomized)||Episodes||Standard Error|Mean
721091|NCT00318656|Secondary|Duration of Hypoglycaemia (<60 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment|Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.|Baseline and 12 weeks|ITT (randomized)||Hours||Standard Error|Mean
721092|NCT00318656|Secondary|Episodes of Hypoglycaemia (<80 mg/dL) at Baseline Compared to After 12 Weeks on Treatment|Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.|Baseline and 12 weeks|ITT (randomized)||Episodes||Standard Error|Mean
721093|NCT00318656|Secondary|Duration of Hypoglycaemia (<80 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment|Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.|Baseline and 12 weeks|ITT (randomized)||Hours||Standard Error|Mean
721094|NCT00318656|Secondary|Episodes of Severe Hyperglycaemia (>150 mg/dL) at Baseline Compared to After 12 Weeks on Treatment|Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.|Baseline and 12 weeks|ITT (randomized)||Episodes||Standard Error|Mean
721095|NCT00318656|Secondary|Duration of Severe Hyperglycaemia (>150 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment|Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.|Baseline and 12 weeks|ITT (randomized)||Hours||Standard Error|Mean
721096|NCT00318656|Primary|Episodes of Hyperglycaemia (>126 mg/dL) at Baseline Compared to After 12 Weeks on Treatment|Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.|Baseline and 12 weeks|ITT (randomized)||Episodes||Standard Error|Mean
721097|NCT00318656|Primary|Duration of Hyperglycaemia (>126 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment|Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.|Baseline and 12 weeks|ITT (randomized): This Intent-to-treat (ITT) population included all subjects who had been randomised, who had received at least one dose of study medication, and for whom at least one efficacy criteria on treatment period was available. The ITT population was the primary population for the efficacy analysis.||Hours||Standard Error|Mean
721098|NCT00318708|Secondary|Adverse Events||Measured during the 16-week treatment period||||||
721099|NCT00318708|Secondary|AM Cortisol||Measured during the 16-week treatment period||||||
721100|NCT00318708|Secondary|Blood Cell Counts||Measured during the 16-week treatment period||||||
721101|NCT00318708|Secondary|Exhaled Nitric Oxide (eNO)||Measured during the 16-week treatment period||||||
721102|NCT00318708|Secondary|Methacholine Provocative Concentration (PC20)||Measured during the 16-week treatment period||||||
721103|NCT00318708|Secondary|Asthma-specific Quality of Life||Measured during the 16-week treatment period||||||
721104|NCT00318708|Secondary|Forced Expiratory Volume in One Second (FEV1)||Measured during the 16-week treatment period||||||
721105|NCT00318708|Secondary|AM and PM Peak Expiratory Flow (PEF)||Measured during the 16-week treatment period||||||
721106|NCT00318708|Secondary|Asthma Rescue Medication Use||Measured during the 16-week treatment period||||||
721107|NCT00318708|Secondary|Asthma Symptoms||Measured during the 16-week treatment period||||||
721108|NCT00318708|Primary|Juniper Asthma Control Questionnaire (ACQ) Results|The Juniper asthma control questionnaire (ACQ) consists of six questions answered by the asthma patient with respect to symptoms, rescue medication use, and night-time awakenings due to asthma. A seventh item in the ACQ is the percent predicted FEV1. Each of the seven items is scored from from 0 (best) to 6 (worst), and then the seven items are averaged to yield a number from 0 (best) to 6 (worst). Asthma patients needed to display an ACQ greater than or equal to 1.25 in order to be eligible for randomization. A reduction of 0.5 units or more in the ACQ over the 16 weeks of treatment is considered to be clinically significant.|Measured every four weeks during the 16-week treatment period, with the change (week 16 minus baseline) as the primary outcome|The number of participants for the analysis was determined as the number who completed the full 16 weeks (value at 16 weeks minus value at baseline).||units on a scale||Standard Error|Least Squares Mean
721109|NCT00318812|Secondary|Transferrin Saturation|Comparison of Transferrin Saturation between the Groups|6 Months|||percentage of bound iron sites||Inter-Quartile Range|Median
721110|NCT00318812|Secondary|Ferritin|Comparison of Ferritin at 6 months between the 2 Groups|6 months|||ug/L||Inter-Quartile Range|Median
721111|NCT00318812|Primary|Hemoglobin Concentration at 6 Months||6 months|||g/L||Inter-Quartile Range|Median
721112|NCT00318929|Secondary|Change From Baseline as Measured by the Seizure Severity Questionnaire (SSQ)|Seizure Severity Questionnaire summary score, on a scale of 1 to 7 with one being the least severe and 7 being the most severe, components of seizures include; warning, activity and recovery|24 weeks||||||
721113|NCT00318929|Secondary|Number of Seizures Per Month|Count of seizures per month determined by seizures recorded in diaries.|24 weeks||||||
721114|NCT00318929|Secondary|Patient's Compliance With Once a Day Dosing.|Subjects pill count for once a day dosing and compliance with medication as a percent of total doses prescribed.|24 weeks||||||
721115|NCT00318929|Primary|Effectiveness of Medication as Measured by Participation Through the End of the Trial.|Number of participants completing the trial|24 weeks|||participants|||Number
721116|NCT00319020|Primary|Number of Subjects With Adverse Events Leading to Premature Discontinuation of Study Treatment||From the first study drug administration in FUTURE 1, for an average of 31 months|||Participants|||Number
721117|NCT00319020|Primary|Proportion of Patients With Treatment-emergent Hemoglobin Abnormalities|"The main study objective was to assess the long-term safety and tolerability of bosentan in children with PAH, including hemoglobin abnormalities.
Proportion of patients with marked hemoglobin decreases (i.e., decrease of or above 15% of the lower normal limit (LL)) is reported here."|After baseline, up to 1 calendar day after study treatment discontinuation in FUTURE 1 or FUTURE 2, i.e. 31 months in average|All-treated analysis set (all patients who received at least one dose of study drug in the combined FUTURE 1 / FUTURE 2 trial periods). Missing or incomplete data were treated as missing.||Percentage of participants|||Number
721118|NCT00319020|Primary|Proportion of Patients With Treatment-emergent Liver Function Abnormalities|"The main study objective was to assess the long-term safety and tolerability of bosentan in children with PAH, including laboratory abnormalities related to liver enzymes.
Proportion of patients with increase in alanine aminotransferase (ALT) or aspartate aminotransferase (AST) above 3 times upper limit of normal (ULN) is reported here."|After baseline, up to 1 calendar day after study treatment discontinuation in FUTURE 1 or FUTURE 2, i.e. 31 months in average|All-treated analysis set (all patients who received at least one dose of study drug in the combined FUTURE 1 / FUTURE 2 trial periods). Missing or incomplete data were treated as missing.||Percentage of participants|||Number
721119|NCT00319020|Primary|Change From Baseline to End of Study (EOS) in Pulse Rate|The main study objective was to assess the long-term safety and tolerability of bosentan in children with PAH, including changes from baseline in pulse rate.|From baseline (FUTURE 1) up to 28 days after study treatment discontinuation (EOS or premature study treatment discontinuation), i.e. 32 months in average|All-treated analysis set (all patients who received at least one dose of study drug in the combined FUTURE 1 / FUTURE 2 trial periods). Missing or incomplete data were treated as missing.||Beats per minutes||Full Range|Median
721120|NCT00319020|Primary|Change From Baseline to End of Study (EOS) in Diastolic Blood Pressure (DBP)|The main study objective was to assess the long-term safety and tolerability of bosentan in children with PAH, including changes from baseline in blood pressure.|From baseline (FUTURE 1) up to 28 days after study treatment discontinuation (EOS or premature study treatment discontinuation), i.e. 32 months in average|All-treated analysis set (all patients who received at least one dose of study drug in the combined FUTURE 1 / FUTURE 2 trial periods). Missing or incomplete data were treated as missing.||mmHg||Full Range|Median
721121|NCT00319020|Primary|Change From Baseline to End of Study (EOS) in Systolic Blood Pressure (SBP)|The main study objective was to assess the long-term safety and tolerability of bosentan in children with PAH, including changes from baseline in blood pressure.|From baseline (FUTURE 1) up to 28 days after study treatment discontinuation (EOS or premature study treatment discontinuation), i.e. 32 months in average|All-treated analysis set (all patients who received at least one dose of study drug in the combined FUTURE 1 / FUTURE 2 trial periods). Missing or incomplete data were treated as missing.||mmHg||Full Range|Median
721122|NCT00319020|Primary|Change From Baseline to End of Study (EOS) in Body Weight|The main study objective was to assess the long-term safety and tolerability of bosentan in children with PAH, including growth as measured by changes from baseline in body weight and height.|From baseline (FUTURE 1) up to 28 days after study treatment discontinuation (EOS or premature study treatment discontinuation), i.e. 32 months in average|All-treated analysis set (all patients who received at least one dose of study drug in the combined FUTURE 1 / FUTURE 2 trial periods). Missing or incomplete data were treated as missing.||kg||Full Range|Median
721123|NCT00319020|Primary|Change From Baseline to End of Study (EOS) in Height for Age.|"In order to compare the growth data with those of healthy children, growth curves are calculated from height data collected throughout the follow-up period. For each patient, height measured at each study visit was converted to a z-score and expressed in standard deviations (SD) from WHO growth standards. The Z-score was calculated according to the following formula:
Z-score = (observed value of the study participant - median value of the reference population) / SD value of the reference population"|From baseline (FUTURE 1) up to 28 days after study treatment discontinuation (EOS or premature study treatment discontinuation), i.e. 32 months in average|All-treated analysis set (all patients who received at least one dose of study drug in the combined FUTURE 1 / FUTURE 2 trial periods). Missing or incomplete data were treated as missing.||Z-score||Full Range|Median
721124|NCT00319046|Secondary|Percent Change in Spleen Volume|Spleen volume was assessed at baseline and end of treatment by magnetic resonance imaging|baseline to end of treatment (month 24 or imputed value)|The analysis was performed on those non-splenectomized patients who had a post-baseline assessment of spleen volume while on treatment with miglustat||percentage change||Standard Deviation|Mean
721125|NCT00319046|Primary|Percent Change in Liver Volume|Liver volume was assessed at baseline and end of treatment by magnetic resonance imaging|baseline to end of treatment (month 24 or imputed value)|One patient was excluded from analysis as the baseline liver volume not available||percentage change||Standard Deviation|Mean
721126|NCT00319046|Secondary|Spleen Volume|Spleen volume was assessed at baseline and end of treatment by magnetic resonance imaging|baseline to end of treatment (month 24 or imputed value)|The analysis was performed on those non-splenectomized patients who had a post-baseline assessment of spleen volume while on treatment with miglustat||cm^3||Standard Deviation|Mean
721127|NCT00319046|Primary|Liver Volume|Liver volume was assessed at baseline and end of treatment by magnetic resonance imaging|baseline to end of treatment (month 24 or imputed value)|One patient was excluded from analysis as the baseline liver volume not available||cm^3||Standard Deviation|Mean
721128|NCT00319098|Secondary|Number of Seroprotected Subjects Against A/Vietnam Influenza Strain|Seroprotection rate was defined as the number of vaccinees with a serum HI titer ≥1:40 that usually is accepted as indicating protection.|At Day 0 (PRE), Day 21 and Day 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects of the immunogenicity subset for whom data concerning immunogenicity endpoint measures were available. This includes subjects for whom assay results were available after vaccination.||Participants|||Count of Participants
721129|NCT00319098|Secondary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/Vietnam Influenza Strain|Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to day 0.|At Day 21 and Day 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects of the immunogenicity subset for whom data concerning immunogenicity endpoint measures were available. This includes subjects for whom assay results were available after vaccination.||Titer fold increase||95% Confidence Interval|Geometric Mean
721130|NCT00319098|Secondary|Number of Seroconverted Subjects Against H5N1|Seroconversion rate for Haemagglutinin antibody response was defined as the number of vaccinees who had either a pre-vaccination titer lower than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40 or a pre-vaccination titer ≥ 1:10 and at least a fourfold increase in post-vaccination titer. Seroconversion rate for Neutralising antibody response was defined as the percentage of vaccinees with a minimum 4-fold increase in titer at post-vaccination.|At Day 21 and Day 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects of the immunogenicity subset for whom data concerning immunogenicity endpoint measures were available. This includes subjects for whom assay results were available after vaccination.||Participants|||Count of Participants
721131|NCT00319098|Secondary|Anti- Haemagglutinin Antibody (Anti-HA) Titers Against Avian Influenza A Subtype H5N1|Anti-HA antibody titers were expressed as Geometric Mean Tiyers (GMTs).|At Day 0 (PRE), 21 and 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects of the immunogenicity subset for whom data concerning immunogenicity endpoint measures were available. This includes subjects for whom assay results were available after vaccination.||Titers||95% Confidence Interval|Geometric Mean
721132|NCT00319098|Primary|Number of Subjects With Medically Significant Conditions (MSCs)|MSCs prompting emergency room or physician visits that were not related to common diseases or routine visits. Common diseases included upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|From Day 0 to Day 51|The analysis was performed on the TVc which included all vaccinated subjects for whom data were available at Day 51.||Participants|||Count of Participants
721133|NCT00319098|Primary|Number of Subjects With New Onset Chronic Diseases (NOCDs)|NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.|From Day 0 to Day 180|The analysis was performed on the Vaccinated Cohort (Extended follow-up) which included all vaccinated subjects for whom data were available at Day 180.||Participants|||Count of Participants
721134|NCT00319098|Primary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Day 0 to Day 180|The analysis was performed on the Vaccinated Cohort (Extended follow-up) which included all vaccinated subjects for whom data were available at Day 180.||Participants|||Count of Participants
721135|NCT00319098|Primary|Number of Subjects With AEs|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. Related symptoms were not available.|During the 30 Day (Days 0-29) post Dose 2|The analysis was performed on the TVc which included all subjects who had received the second dose and for whom data were available.||Participants|||Count of Participants
721136|NCT00319098|Primary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. Related symptoms were not available.|During the 21st Day (Days 0-20) post Dose 1|The analysis was performed on the TVc which included all vaccinated subjects for whom data were available and with the symptom sheet filled in at Day 51.||Participants|||Count of Participants
721137|NCT00319098|Primary|Number of Subjects With Solicited General Symptoms (Across Doses)|Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, myalgia, shivering, sweating. Any = occurrence of symptom regardless of intensity grade and relationship to vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 Fever = fever higher than (>) 39.0 °C. Related = symptom considered by the investigator to be casually related with the study vaccination.|During the 7-day (Days 0-6) post vaccination across dosses|The analysis was performed on the TVc which included all vaccinated subjects for whom data were available and with the symptom sheet filled in.||Participants|||Count of Participants
721138|NCT00319098|Primary|Number of Subjects With Solicited General Symptoms (Dose 2)|Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, myalgia, shivering, sweating. Any = occurrence of symptom regardless of intensity grade and relationship to vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 Fever = fever higher than (>) 39.0 °C. Related = symptom considered by the investigator to be casually related with the study vaccination.|During the 7-day (Days 0-6) after Dose 2|The analysis was performed on the TVc which included all vaccinated subjects for whom data were available and with the symptom sheet filled in.||Participants|||Count of Participants
721139|NCT00319098|Primary|Number of Subjects With Solicited General Symptoms (Dose 1)|Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, myalgia, shivering, sweating. Any = occurrence of symptom regardless of intensity grade and relationship to vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 Fever = fever higher than (>) 39.0 °C. Related = symptom considered by the investigator to be casually related with the study vaccination.|During the 7-day (Days 0-6) after Dose 1|The analysis was performed on the TVc which included all vaccinated subjects for whom data were available and with the symptom sheet filled in.||Participants|||Count of Participants
721301|NCT00307125|Secondary|Number of Participants With Viral Replication of Polyomavirus (BKV)|Number of participants with viral replication of BKV within 12 month post treatment initiation. Measured by polymerase chain reaction (PCR) method. Evidence of viral replication is indicative of a BKV infection. Polyomavirus BK is a significant pathogen in transplant recipients.|1 year post treatment initiation|Intent-to-treat||participants|||Number
721140|NCT00319098|Primary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling. Any = occurrence of symptom regardless of intensity grade. Grade 3 Pain = pain that prevented normal everyday activities Grade 3 ecchymosis/induration/redness/swelling = redness/swelling spreading beyond (>) 50 millimeters (mm) in diameter|During a 7 day follow-up period after each dose of vaccine and overall.|The analysis was performed on the Total Vaccinated cohort (TVc) which included all vaccinated subjects for whom data were available and with the symptom sheet filled in.||Participants|||Count of Participants
721141|NCT00319111|Secondary|Occurrence of Liver Function Test and Hemoglobin Abnormality|Number of patients with an increase in liver aminotransferases to >3 times upper limit of normal (ULN) or a decrease in hemoglobin concentration to ≤10 g/dL|Until discontinuation of study drug, up to 3.3 years|study population||participants|||Number
721142|NCT00319111|Secondary|Number of Patients Experiencing a Serious Adverse Event(s) up to 28 Days After Study Medication Discontinuation||28 days after discontinuation of study drug, up to 3.3 years|Study population||participants|||Number
721143|NCT00319111|Secondary|Number of Patients With an Adverse Event(s) Leading to Premature Discontinuation of Study Medication||Until discontinuation of study drug, up to 3.3 years|Study population||participants|||Number
721144|NCT00319111|Primary|Time to Clinical Worsening up to End-of-study|An event of clinical worsening was defined as death during the treatment period, a treatment-emergent adverse event that led to permanent discontinuation of study treatment and with outcome death, hospitalization due to worsening pulmonary hypertension, or lung transplantation. Patients are censored at 1 day after the end of treatment or at day of pulmonary endarterectomy if earlier.|Until discontinuation of study drug, up to 3.3 years|Study population||participants|||Number
721145|NCT00319111|Primary|Disease Severity - Number of Patients Showing Improvement by One Class or More in World Health Organisation (WHO) Functional Classification of Pulmonary Hypertension (PH)|"Disease severity was assessed by WHO classification of PH criteria:
Class I: no limitation of physical activity (PA). Ordinary PA: no undue dyspnea/fatigue, chest pain, near syncope.
Class II: slight limitation of PA. Comfortable at rest. Ordinary PA: undue dyspnea/fatigue, chest pain, near syncope.
Class III: marked limitation of PA. Comfortable at rest. Less than ordinary PA: undue dyspnea/fatigue, chest pain, near syncope.
Class IV: inability to carry out PA without symptoms. Right heart failure. Dyspnea/fatigue may even have been present at rest. Discomfort increased by any PA."|Until discontinuation of study drug, up to 3.3 years|Numbers of patients assessed at 6 month, month 12, month 18, month 24 and end of the treatment period were 138, 129, 123, 109, and 139 respectively||participants with improved WHO class|||Number
721146|NCT00319111|Primary|Change From Baseline to All Assessed Time Points in Borg Dyspnea Index|Maximal dyspnea during the walk test was assessed by the patient using the Borg dyspnea index. Immediately following each walk test, patients rated perceived maximal breathlessness during the walk test on a 12-point scale (0 [nothing at all], 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 [maximum ever experienced]).|Until discontinuation of study drug, up to 3.3 years|Numbers of patients assessed at 6 month, month 12, month 18, month 24 and end of the treatment period were 136, 127, 120, 105, and 136 respectively||Scores on a scale||Standard Deviation|Mean
721147|NCT00319111|Primary|Change From Baseline to All Assessed Time Points in 6-minute Walk Test (6MWT) Distance|Exercise capacity was assessed using the 6MWT. Area used for testing had to be a minimum of 30m in length and 2-3m in width, with 3m gradations. Areas were well ventilated with air temperature controlled. The test was administered at the same time of day and by the same tester throughout the study. The tester measured the distance walked by non-encouraged patients during the timed 6min period. If the test was stopped before 6 minutes, the main reason for stopping the test was recorded. The tester measured the distance walked by patients during the timed 6min period.|Until discontinuation of study drug, up to 3.3 years|Numbers of patients assessed at 6 month, month 12, month 18, month 24 and end of the treatment period were 137, 128, 121, 106, and 137 respectively||walk distance change from baseline (m)||Standard Deviation|Mean
721148|NCT00319254|Other Pre-specified|Population Pharmacokinetics (PK)|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Pre-dose, 2, 7, 20 hours post-dose on Day 1 of Week 4 and pre-dose on Day 1 of Weeks 1, 8, 12, 16, and 24||||||
721149|NCT00319254|Secondary|Change From Baseline in Karnofsky Performance Status (KPS) at Week 1, 4, 8, 12, 16, Every 8 Weeks Thereafter and 14 Days After Last Dose of Study Treatment|KPS: 11 level score ranged 100 to 0, to assess functional impairment. 100:Normal; 90:Able to carry on normal activity; 80:Normal activity with effort, some signs or symptoms of disease; 70:Cares for self, unable to carry on normal activity or to do active work; 60:Requires occasional assistance but is able to care for most of needs; 50:Requires considerable assistance and frequent medical care; 40:Disabled,requires special care and assistance; 30:Severely disabled; hospitalization indicated although death is not imminent; 20:Very sick; 10:Morbibund,fatal processes progressing rapidly; 0:Death.|Baseline, Weeks 1,4,8,12,16, every 8 weeks thereafter and 14 days after last dose of study treatment|Data for this pre-specified outcome was collected but not statistically summarized for analysis as there were no clinically significant changes observed.|||||
721150|NCT00319254|Secondary|Concomitant Medications Used for Management of Adverse Events (AEs)|Number of participants taking any non-study medications which were administered from Study Day 1 to last dose of study treatment (Week 77) as a management of an AE were to be reported.|Day 1 up to end of treatment (Week 77)|Data for this pre-specified outcome measure was not statistically summarized for analysis, but collected and reported in individual participant listings as planned.|||||
721151|NCT00319254|Secondary|Number of Participants With Change From Baseline in Vital Signs, Physical Examinations, and Ophthalmological Examinations|Number of participants with potentially clinically significant (PCS) vital signs and physical examinations are reported. Criteria for PCS vital signs include: respiratory rate >25 breaths/minute and PCS physical examinations include: an increase or decrease from baseline of >=7% in body weight.|Baseline up to end of treatment (Week 77)|"Safety population included all enrolled participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) represents number of participants who had at least 1 on-treatment assessment."||participants|||Number
721152|NCT00319254|Secondary|Number of Participants With Change From Baseline in Electrocardiogram (ECG)|Number of participants with potentially clinically significant (PCS) ECG findings are reported. Criteria for PCS ECG findings include: no sinus rhythm; heart rate >=120 beats per minute (bpm) or increase >=15 bpm; QT interval corrected using Bazett's formula (QTcB) >60 milliseconds (msec) change from baseline; and overall ECG evaluation not normal.|Baseline up to end of treatment (Week 77)|"Safety population included all enrolled participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) represents number of participants who had at least 1 on-treatment assessment."||participants|||Number
721153|NCT00319254|Secondary|Number of Participants With Change From Baseline in Laboratory Test Results|Number of participants with potentially clinically significant (PCS) laboratory values are reported. Criteria for PCS laboratory values include: aspartate aminotransferase (AST), alanine aminotransferase (ALT) >5*upper limit of normal(ULN) milliunit/milliliter(mU/mL); total bilirubin >3*ULN micromole/L; sodium <130, magnesium <0.4 and >1.23 millimole/L; lipase >2*ULN microkats/L; neutrophils <1*10^9/L. Participants meeting at least 1 PCS criteria are reported.|Baseline up to end of treatment (Week 77)|"Safety population included all enrolled participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) represents number of participants who had at least 1 on-treatment assessment."||participants|||Number
721154|NCT00319254|Secondary|Percentage of Participants With Clinical Benefit|Clinical benefit was defined as a confirmed CR or PR, or stable disease (SD) for more than (>) 24 weeks as the best response before the first evidence of progressive disease (PD). A participant demonstrating CR, PR, or SD >24 weeks at any time while on study was counted in the numerator.|Baseline up to end of treatment (Week 77)|ITT population included all enrolled participants who received at least 1 dose of study treatment.||percentage of participants||95% Confidence Interval|Number
721155|NCT00319254|Secondary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR was based on the assessment of confirmed complete remission (CR) or confirmed partial remission (PR) according to sponsor modified Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all target and non-target lesions. Confirmed PR defined as more than or equal to (>=) 30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD. Confirmed responses are those that persist on repeat imaging study >=4 weeks after initial documentation of response.|Baseline up to Year 1|ITT population included all enrolled participants who received at least 1 dose of study treatment.||percentage of participants||95% Confidence Interval|Number
721156|NCT00319254|Secondary|Overall Survival (OS)|OS was estimated by Kaplan-Meier method. Survival was defined as the time period from the date of first dose of study treatment to the date of death, censored at the participant's last contact date. Percentage of participants who were still alive at 2 years is reported.|Baseline up to Year 2|ITT population included all enrolled participants who received at least 1 dose of study treatment.||percentage of participants||95% Confidence Interval|Number
721157|NCT00319254|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.|Baseline up to 30 days after last dose of study treatment|Safety population included all enrolled participants who received at least 1 dose of study treatment.||percentage of participants|||Number
721158|NCT00319254|Primary|Progression-Free Survival (PFS) Rate|PFS was based on Kaplan-Meier estimates. PFS was defined as time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from death case report forms (CRFs). Percentage of participants who had not experienced progression or death by Week 16 is reported.|Baseline up to Week 16|Intent-To-Treat (ITT) population included all enrolled participants who received at least 1 dose of study treatment.||percentage of participants||95% Confidence Interval|Number
721159|NCT00301080|Secondary|Change in the Amount of Opioid Medication Used by Patients in Each Arm Before and After Study Treatment|Record the amount of opioid medication used by patients in each arm before and after the study treatment period.|From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year)|No patients were analyzed for this outcome measure due to a change in study design followed by early termination of the study.|||||
721160|NCT00301080|Secondary|Differences in Pain Interference Between Study Arms Using the Brief Pain Inventory and the FACT-Taxane|Compare the pain interference scores after study treatment between study arms using the brief pain inventory and the FACT-Taxane.|From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year)|No patients were analyzed for this outcome measure due to a change in study design followed by early termination of the study.|||||
721161|NCT00301080|Secondary|Change in Neuropathic Pain Scores in and Between Study Arms Using the Neuropathic Pain Inventory, the FACT-Taxane, and the Leonard Scale.|Compare changes in neuropathic pain scores within each arm, as well as between the 3 arms of the study. Neuropathic pain will be assessed using 3 tools: the Neuropathic Pain Inventory, the FACT-Taxane, and the Leonard Scale.|From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year)|No patients were analyzed for this outcome measure due to a change in study design followed by early termination of the study.|||||
721162|NCT00301080|Secondary|Change in Individual Patients' Self-reported Overall Pain Relief Scores Before and After the Treatment Period|Compare individual patients' self-reported pain relief scores before and after the treatment period.|From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year)|No patients were analyzed for this outcome measure due to a change in study design followed by early termination of the study.|||||
721163|NCT00301080|Primary|Difference in Patient-reported Pain Intensity Scores Between the 3 Arms After the Treatment Period Using the Brief Pain Inventory|Compare patient-reported pain intensity scores after the treatment period (12 weeks) between the 3 arms of the trial.|From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year)|No patients were analyzed for this outcome measure due to a change in study design followed by early termination of the study.|||||
721164|NCT00301262|Secondary|Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Frequency of Second Erections|Percentage of occasions at which second erection was achieved. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of ‘Yes’ within visit interval) / (number of occasions within visit interval) x 100.|Baseline to <Week 8 and Week 8 to <=Week 14|number of subjects in the FAS population with an observation||percentage of occasions||Standard Deviation|Mean
721165|NCT00301262|Secondary|Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 3 or 4|Per-patient percentage of hardness of second erections: Grade 3 = hard enough for penetration but not completely hard, Grade 4 = completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of ‘Yes’ within visit interval) / (number of occasions within visit interval) x 100.|Baseline to <Week 8 and Week 8 to <=Week 14|number of subjects in the FAS population with an observation||percentage of occasions||Standard Deviation|Mean
721166|NCT00301262|Secondary|Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 4|Per-patient percentage of hardness of second erections:Grade 4 = completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of ‘Yes’ within visit interval) / (number of occasions within visit interval) x 100.|Baseline to <Week 8 and Week 8 to <=Week 14|number of subjects in the FAS population with an observation||percentage of occasions||Standard Deviation|Mean
721167|NCT00301262|Secondary|Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 3|Per-patient percentage of hardness of second erections:Grade 3 = hard enough for penetration but not completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of ‘Yes’ within visit interval) / (number of occasions within visit interval) x 100.|Baseline to <Week 8 and Week 8 to <=Week 14|number of subjects in the FAS population with an observation||percentage of occasions||Standard Deviation|Mean
721168|NCT00301262|Secondary|Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 2|Per-patient percentage of hardness of second erections:Grade 2 = hard but not hard enough for penetration. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of ‘Yes’ within visit interval) / (number of occasions within visit interval) x 100.|Baseline to <Week 8 and Week 8 to <=Week 14|number of subjects in the FAS population with an observation||percentage of occasions||Standard Deviation|Mean
721169|NCT00301262|Secondary|Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 1|Per-patient percentage of hardness of second erections: Grade 1 = increase in size but not hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of ‘Yes’ within visit interval) / (number of occasions within visit interval) x 100.|Baseline to <Week 8 and Week 8 to <=Week 14|number of subjects in the FAS population with an observation||percentage of occasions||Standard Deviation|Mean
721170|NCT00301262|Secondary|Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 0|Per-patient percentage of hardness of second erections: Grade 0 = no erection at all. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of ‘Yes’ within visit interval) / (number of occasions within visit interval) x 100.|Baseline to <Week 8 and Week 8 to <=Week 14|number of subjects in the FAS population with an observation||percentage of occasions||Standard Deviation|Mean
721171|NCT00301262|Secondary|Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 3 or 4|Per-patient percentage of hardness of erections: Grade 3 = hard enough for penetration but not completely hard, Grade 4 = completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of ‘Yes’ within visit interval) / (number of occasions within visit interval) x 100.|Baseline to <Week 8 and Week 8 to <=Week 14|number of subjects in the FAS population with an observation||percentage of occasions||Standard Deviation|Mean
721172|NCT00301262|Secondary|Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 4|Per-patient percentage of hardness of erections: Grade 4 = completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of ‘Yes’ within visit interval) / (number of occasions within visit interval) x 100.|Baseline to <Week 8 and Week 8 to <=Week 14|number of subjects in the FAS population with an observation||percentage of occasions||Standard Deviation|Mean
721173|NCT00301262|Secondary|Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 3|Per-patient percentage of hardness of erections: Grade 3 = hard enough for penetration but not completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of ‘Yes’ within visit interval) / (number of occasions within visit interval) x 100.|Baseline to <Week 8 and Week 8 to <=Week 14|number of subjects in the FAS population with an observation||percentage of occasions||Standard Deviation|Mean
721174|NCT00301262|Secondary|Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 2|Per-patient percentage of hardness of erections: Grade 2 = hard but not hard enough for penetration. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of ‘Yes’ within visit interval) / (number of occasions within visit interval) x 100.|Baseline to <Week 8 and Week 8 to <=Week 14|number of subjects in the FAS population with an observation||percentage of occasions||Standard Deviation|Mean
721175|NCT00301262|Secondary|Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 1|Per-patient percentage of hardness of erections: Grade 1 = increase in size but not hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of ‘Yes’ within visit interval) / (number of occasions within visit interval) x 100.|Baseline to <= Week 14|number of subjects in the FAS population with an observation||percentage of occasions||Standard Deviation|Mean
721914|NCT00322621|Secondary|Change From Baseline in Vital Signs: Heart Rate at Week 34 Endpoint||Baseline (Week 0), Week 34|All patients who received either 60 mg or 120 mg duloxetine once daily.||beats per minute||Standard Deviation|Mean
721176|NCT00301262|Secondary|Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 0|Per-patient percentage of hardness of erections:Grade 0 = no erection at all. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of ‘Yes’ within visit interval) / (number of occasions within visit interval) x 100.|Baseline to <Week 8 and Week 8 to <=Week 14|number of subjects in the FAS population with an observation||percentage of occasions||Standard Deviation|Mean
721177|NCT00301262|Secondary|Shift in Responder Rate From Week 8 to Week 14 for GEQ3|GEQ3: When you took a dose of study drug and had sexual stimulation, how often did you get an erection that allowed you to engage in satisfactory sexual intercourse? Responder = almost always or always, most times, or sometimes. Non-responder = a few times (much less than half the time) or almost never or never.|Week 8 to Week 14|number of subjects in the FAS population with an observation: Number of subjects with both Week 8 and Week 14 response to GEQ Question 3 under the treatment.||subjects|||Number
721178|NCT00301262|Secondary|Shift in Responder Rate From Week 8 to Week 14 for GEQ2|GEQ 2: Compared to having no treatment at all for your erection problem, has the medication you have been taking over the past 4 weeks improved your ability to have sexual intercourse? Responder was defined as answering Yes to GEQ 2.|Week 8 to Week 14|number of subjects in the FAS population with an observation: Number of subjects with both Week 8 and Week 14 response to GEQ Question 2 under the treatment.||subjects|||Number
721179|NCT00301262|Secondary|Shift in Responder Rate From Week 8 to Week 14 for Global Efficacy Question (GEQ) 1|GEQ 1: Compared to having no treatment at all for your erection problem, has the medication you have been taking over the past 4 weeks improved your erections? Responder was defined as answering Yes to GEQ 1.|Week 8 to Week 14|number of subjects in the FAS population with an observation: Number of subjects with both Week 8 and Week 14 response to GEQ Question 1 under the treatment.||subjects|||Number
721180|NCT00301262|Secondary|Analog Scales- General Sexual Performance|mean - scale of 0 (worst) to 10 (best)|Week 8, Week 14|number of subjects in the FAS population with an observation||units on a scale||Standard Deviation|Mean
721181|NCT00301262|Secondary|Analog Scales- Reliability|mean - scale of 0 (worst) to 10 (best)|Week 8, Week 14|number of subjects in the FAS population with an observation||units on a scale||Standard Deviation|Mean
721182|NCT00301262|Secondary|Analog Scales- Maintenance|mean - scale of 0 (worst) to 10 (best)|Week 8, Week 14|number of subjects in the FAS population with an observation||units on a scale||Standard Deviation|Mean
721183|NCT00301262|Secondary|Analog Scales- Firmness|mean - scale of 0 (worst) to 10 (best)|Week 8, Week 14|number of subjects in the FAS population with an observation||units on a scale||Standard Deviation|Mean
721184|NCT00301262|Secondary|Change From Baseline to Week 8 in Analog Scales- General Sexual Performance|mean change - scale of 0 (worst) to 10 (best)|baseline to week 8|number of subjects in the FAS population with an observation||units on a scale||Standard Deviation|Mean
721185|NCT00301262|Secondary|Change From Baseline to Week 8 in Analog Scales- Reliability|mean change - scale of 0 (worst) to 10 (best).|baseline to Week 8|number of subjects in the FAS population with an observation||units on a scale||Standard Deviation|Mean
721186|NCT00301262|Secondary|Change From Baseline to Week 8 in Analog Scales- Maintenance|mean change - scale of 0 (worst) to 10 (best).|baseline to Week 8|number of subjects in the FAS population with an observation||units on a scale||Standard Deviation|Mean
721187|NCT00301262|Secondary|Change From Baseline to Week 8 in Analog Scales- Firmness|mean change - scale of 0 (worst) to 10 (best).|baseline to Week 8|number of subjects in the FAS population with an observation||units on a scale||Standard Deviation|Mean
721188|NCT00301262|Secondary|Percentage of Occasions of Ejaculation and/or Orgasm Event Log|Percentage of occasions at which subjects answered yes to the question, did your erection last long enough to have successful intercourse. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of ‘Yes’ within visit interval) / (number of occasions within visit interval) x 100.|Week 8 to Week 14|number of subjects in the FAS population with an observation||percentage of occasions||Standard Deviation|Mean
721189|NCT00301262|Secondary|Percentage of Occasions of Successful Intercourse (Event Log)|Percentage of occasions at which subjects answered yes to the question, did your erection last long enough to have successful intercourse. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of ‘Yes’ within visit interval) / (number of occasions within visit interval) x 100.|Week 8 to Week 14|number of subjects in the FAS population with an observation||percentage of occasions||Standard Deviation|Mean
721190|NCT00301262|Secondary|Percentage of Occasions of Ejaculation and/or Orgasm (Event Log)|Percentage of occasions at which subjects answered yes to the question, did your erection last long enough to have successful intercourse. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of ‘Yes’ within visit interval) / (number of occasions within visit interval) x 100.|Baseline to Week 8|number of subjects in the FAS population with an observation||Percentage of occasions||Standard Deviation|Mean
721191|NCT00301262|Secondary|Percentage of Occasions of Successful Intercourse (Event Log)|Percentage of occasions at which subjects answered yes to the question, did your erection last long enough to have successful intercourse. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of ‘Yes’ within visit interval) / (number of occasions within visit interval) x 100.|Baseline to Week 8|number of subjects in the FAS population with an observation||percentage of occasions||Standard Deviation|Mean
721192|NCT00301262|Secondary|Global Efficacy Question 3 (GEQ3) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14)|GEQ 3: When you took a dose of study drug and had sexual stimulation, how often did you get an erection that allowed you to engage in satisfactory sexual intercourse? Resp. was defined as answering almost always or always, most times, or sometimes, and non-resp was defined as answering a few times or almost never or never.|Week 8, Week 14|number of subjects in the FAS population with an observation||percentage of subjects|||Number
721193|NCT00301262|Secondary|Global Efficacy Question 2 (GEQ2) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14)|GEQ 2: Compared to having no treatment at all for your erection problem, has the medication you have been taking over the past 4 weeks improved your ability to have sexual intercourse? Responder was defined as answering “Yes”. % of responders/non-responders was calculated based on subjects who attempted intercourse.|Week 8, Week 14|number of subjects in the FAS population with an observation||percentage of subjects|||Number
721194|NCT00301262|Secondary|Global Efficacy Question 1 (GEQ1) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14)|GEQ 1: Compared to having no treatment at all for your erection problem, has the medication you have been taking over the past 4 weeks improved your erections?Responder was defined as answering “Yes”. % of responders/non-responders was calculated based on subjects who attempted intercourse.|Week 8, Week 14|number of subjects in the FAS population with an observation||percentage of subjects|||Number
721195|NCT00301262|Secondary|Quality of Erection Questionnaire (QEQ) Total Score|QEQ raw total score (defined as the sum of scores from QEQ Questions 1 and 3 to 7 and ranged from 6 to 30) was transformed to QEQ total score on a scale of 0 (lowest) to 100 (highest).|Week 8, Week 14|Full Analysis Set||scores on a scale||Standard Deviation|Mean
721196|NCT00301262|Secondary|Change From Baseline to End of DB Phase (Week 8) in Quality of Erection Questionnaire (QEQ) Total Score|adjusted mean change - QEQ raw total score (defined as the sum of scores from QEQ Questions 1 and 3 to 7 and ranged from 6 to 30) was transformed to QEQ total score on a scale of 0 (lowest) to 100 (highest).|Week 8|number of subjects in the FAS population with an observation||scores on a scale||Standard Error|Least Squares Mean
721197|NCT00301262|Secondary|Erectile Distress Scale (EDS) Total Score|Possible total scores for EDS range from 5 (all of the time) to 30 (none of the time). Higher scores indicate less impact of ED.|Week 8, Week 14|number of subjects in the FAS population with an observation||scores on a scale||Standard Deviation|Mean
721198|NCT00301262|Secondary|Change From Baseline to End of DB Phase (Week 8) in Erectile Distress Scale (EDS) Total Score|adjusted mean change - Possible total scores for EDS range from 5 (all of the time) to 30 (none of the time). Higher scores indicate less impact of ED.|Week 8|number of subjects in the FAS population with an observation||scores on a scale||Standard Error|Least Squares Mean
721199|NCT00301262|Secondary|International Index of Erectile Function (IIEF) Domain Scores- Overall Satisfaction|Possible total scores for IIEF-SD and IIEF-OS range from 2 (worst) to 10 (best).|Week 8, Week 14|number of subjects in the FAS population with an observation||scores on a scale||Standard Deviation|Mean
721200|NCT00301262|Secondary|International Index of Erectile Function (IIEF) Domain Scores- Intercourse Satisfaction|Possible total scores for IIEF-IS range from 0 (worst) to 15 (best).|Week 8, Week 14|number of subjects in the FAS population with an observation||scores on a scale||Standard Deviation|Mean
721201|NCT00301262|Secondary|International Index of Erectile Function (IIEF) Domain Scores- Sexual Desire|Possible total scores for IIEF-SD and IIEF-OS range from 2 (worst) to 10 (best).|Week 8, Week 14|number of subjects in the FAS population with an observation||scores on a scale||Standard Deviation|Mean
721202|NCT00301262|Secondary|International Index of Erectile Function (IIEF) Domain Scores- Orgasmic Function|Possible total scores for IIEF-OF range from 0 (worst) to 10 (best).|Week 8, Week 14|number of subjects in the FAS population with an observation||scores on a scale||Standard Deviation|Mean
721203|NCT00301262|Secondary|International Index of Erectile Function (IIEF) Domain Scores- Erectile Function|Possible total scores for IIEF-EF range from 1 (worst) to 30 (best).|Week 8, Week 14|number of subjects in the FAS population with an observation||scores on a scale||Standard Deviation|Mean
721204|NCT00301262|Secondary|Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Overall Satisfaction|adjusted mean change - Possible total scores for IIEF-OS range from 2 (worst) to 10 (best).|Week 8|number of subjects in the FAS population with an observation||scores on a scale||Standard Error|Least Squares Mean
721205|NCT00301262|Secondary|Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Intercourse Satisfaction|adjusted mean - Possible total scores for IIEF-IS range from 0 (worst) to 15 (best).|Week 8|number of subjects in the FAS population with an observation||scores on a scale||Standard Error|Least Squares Mean
721206|NCT00301262|Secondary|Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Sexual Desire|adjusted mean change - Possible total scores for IIEF-SD range from 2 (worst) to 10 (best).|Week 8|number of subjects in the FAS population with an observation||scores on a scale||Standard Error|Least Squares Mean
721207|NCT00301262|Secondary|Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Orgasmic Function|adjusted mean change - Possible total scores for IIEF-OF range from 0 (worst) to 10 (best).|Week 8|number of subjects in the FAS population with an observation||scores on a scale||Standard Error|Least Squares Mean
721208|NCT00301262|Secondary|Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Erectile Function|adjusted mean change - Possible total scores for IIEF-EF range from 1 (worst) to 30 (best).|Week 8|number of subjects in the FAS population with an observation||scores on a scale||Standard Error|Least Squares Mean
721209|NCT00301262|Secondary|Patient Reported Erectile Function Assessment (PREFA) Total Score|PREFA Total Score: 8 = worst, 32 = best.|Week 8, Week 14|number of subjects in the FAS population with an observation||scores on a scale||Standard Deviation|Mean
721210|NCT00301262|Secondary|Change From Baseline to End of Double-Blind Phase (Week 8) in Patient Reported Erectile Function Assessment (PREFA) Total Score|adjusted mean change; PREFA Total Score: 8 = worst; 32 = best.|Week 8|number of subjects in the FAS population with an observation||scores on a scale||Standard Error|Least Squares Mean
721211|NCT00301262|Secondary|Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Index|Possible scores for the EDITS Index range from 0 (extremely low treatment satisfaction) to 100 (extremely high treatment satisfaction).|Week 8, Week 14|number of subjects in the FAS population with an observation||scores on a scale||Standard Deviation|Mean
721212|NCT00301262|Primary|Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Index at the End of the DB Treatment (Week 8)|adjusted mean : Possible scores for the EDITS Index range from 0 (extremely low treatment satisfaction) to 100 (extremely high treatment satisfaction).|Week 8|number of subjects in the Full Analysis Set (FAS) population with an observation||scores on a scale||Standard Error|Least Squares Mean
721293|NCT00307047|Secondary|Ischemia Driven Target Lesion Revascularization (TLR)|"Revascularization of a target lesion associated with any of the following:
positive functional ischemia study
ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study"|30 days|ITT population.||percentage of participants|||Number
721213|NCT00301366|Primary|Treatment-emergent Adverse Events (TEAEs) Defined as Any Adverse Event (AE) Occurring During or After the Start of the First Study Drug Infusion.|An adverse event is any untoward medical occurrence in a subject or clinical investigation subject administered with a pharmaceutical product. The adverse event does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product, whether or not considered related to the medicinal product.|24 weeks|38 subjects received study medication and one subject discontinued from the study due to an AE. Therefore, 37 subjects completed the study. 18 subjects were naive ((i.e., never having received previous Alpha-1 protease inhibitor augmentation therapy) and 19 subjects were non-naive.||Participants|||Number
721214|NCT00301418|Secondary|Overall Survival (OS)||Duration of the trial|||days||95% Confidence Interval|Median
721215|NCT00301418|Secondary|6-month Progression Free Survival (PFS)||Duration of the trial|||days||95% Confidence Interval|Median
721216|NCT00301418|Primary|Safety of Twice a Day Oral 150 mg Erlotinib Dosing|Greater than or equal to Grade 2 Adverse Event|duration of the trial|||participants|||Number
721217|NCT00307034|Secondary|Number of Subjects With Serious Adverse Events|A SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalisation, as per the medical or scientific judgement of the physician. Any = Occurrence of a SAE, regardless of relationship to vaccination.|During the booster vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects (i.e. who had received at least one dose of study vaccine during the primary vaccination course or the booster dose).||Subjects|||Number
721218|NCT00307034|Secondary|Number of Subjects With Serious Adverse Events|A SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalisation, as per the medical or scientific judgement of the physician. Any = Occurrence of a SAE, regardless of relationship to vaccination.|During the primary vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects (i.e. who had received at least one dose of study vaccine during the primary vaccination course or the booster dose).||Subjects|||Number
721219|NCT00307034|Secondary|Number of Subjects With Unsolicited Adverse Events|An unsolicited AE was defined as any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination.|Within the 31-day (Days 0-30) post booster vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects (i.e. who had received at least one dose of study vaccine during the primary vaccination course or the booster dose).||Subjects|||Number
721220|NCT00307034|Secondary|Number of Subjects With Unsolicited Adverse Events|An unsolicited AE was defined as any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination.|Within the 31-day (Days 0-30) post-primary vaccination period, across doses|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects (i.e. who had received at least one dose of study vaccine during the primary vaccination course or the booster dose).||Subjects|||Number
721221|NCT00307034|Secondary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, irritability/fussiness (Irr./Fuss.), loss of appetite (Loss Appet.) and fever (rectal temperature higher than [≥] 38.0 degrees Celsius [°C]). Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irr./Fuss. = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = Rectal temperature higher than (>) 40.0°C. Across doses= across the 2 doses of the Synflorix™ vaccine in the Synflorix I group and across the 3 doses of the Synflorix™ vaccine in the Synflorix II group.|During the 4-day (Days 0-3) period following the primary vaccination (across doses) and during the 4-day (Days 0-3) period following the booster vaccination (post Booster) with the Synflorix™ vaccine|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects (i.e. who had received at least one dose of study vaccine during the primary vaccination course or the booster dose).||Subjects|||Number
721222|NCT00307034|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm). Across doses= across the 2 doses of the Synflorix™ vaccine in the Synflorix I group and across the 3 doses of the Synflorix™ vaccine in the Synflorix II group.|During the 4-day (Days 0-3) period following the primary vaccination (across doses) and during the 4-day (Days 0-3) period following the booster vaccination (post Booster) with the Synflorix™ vaccine|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects (i.e. who had received at least one dose of study vaccine during the primary vaccination course or the booster dose).||Subjects|||Number
721223|NCT00307034|Secondary|Number of Subjects With Booster Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN Antibodies|Booster vaccine response to pertussis toxoid (PT), filamentous haemagglutinin (FHA) and pertactin (PRN), defined as the appearance of antibodies in subjects who were seronegative (Pre-booster status S-) (i.e., with antibody concentrations < 5 EL.U/mL) just before booster dose, and at least two-fold increase of pre-vaccination antibody concentrations in those who were seropositive (Pre-booster status S+) (i.e., with antibody concentrations ≥ 5 EL.U/mL) just before booster dose.|One month after (Month 9) the administration of the booster dose of Synflorix™ vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity concerning data were available.||Subjects|||Number
721224|NCT00307034|Secondary|Antibody Titers Against Polio Type 1, 2 and 3 (Anti-polio 1, 2 and 3)|Titers of antibodies are presented as geometric mean titers. Seroprotection status was defined as anti-polio types 1, 2 and 3 (Anti-polio 1, 2 and 3) antibody titers greater than or equal to (≥) the value of 8. This outcome concerns results for the Primary and Booster Phases of the study and included only the subset of subjects who received Infanrix Hexa™ as the co-administered vaccine.|One month post-dose 2 (Month 3) administration, one month before (Month 9) and one month after (Month 10) the booster dose of Synflorix™ vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity concerning data were available.||Titers||95% Confidence Interval|Geometric Mean
721225|NCT00307034|Secondary|Antibody Concentrations Against Hepatitis B Surface Antigen (Anti-HBs)|Concentrations of antibodies are presented as geometric mean concentrations, expressed as milli international units per milliliter (mIU/mL). Seroprotection status was defined as anti-hepatitis B surface antigen (anti-HBs) antibody concentrations greater than or equal to (≥) the cut-off value of 10 mIU/mL. This outcome concerns results for the Primary and Booster Phases of the study and included only the subset of subjects who received Infanrix Hexa™ as the co-administered vaccine.|One month post-dose 2 (Month 3) administration, one month before (Month 9) and one month after (Month 10) the booster dose of Synflorix™ vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity concerning data were available.||mIU/mL||95% Confidence Interval|Geometric Mean
721226|NCT00307034|Secondary|Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)|Concentrations of antibodies are presented as geometric mean concentrations, expressed as enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). Seropositivity status was defined as anti-pertussis toxoid (Anti-PT), anti-filamentous haemagglutinin (Anti-FHA) and anti-pertactin (Anti-PRN) antibody concentrations greater than or equal to (≥) the cut-off value of 5 EL.U/mL. This outcome concerns results for the Primary and Booster Phases of the study.|One month post-dose 2 (Month 3) administration, one month before (Month 9) and after (Month 10) the booster dose of Synflorix™ vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity concerning data were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
721227|NCT00307034|Secondary|Antibody Concentrations Against Polyribosyl Ribitol Phosphate (Anti-PRP)|Concentrations of antibodies are presented as geometric mean concentrations, expressed as micrograms per milliliter (μg/mL). Seroprotection status was defined as anti-polyribosyl ribitol phosphate (Anti-PRP) antibody concentrations greater than or equal to (≥) the cut-off values of 0.15 μg/mL and ≥ 1.0 μg/mL. This outcome concerns results for the Primary and Booster Phases of the study.|One month post-dose 2 (Month 3) administration, one month before (Month 9) and one month after (Month 10) booster dose of Synflorix™ vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity concerning data were available.||μg/mL||95% Confidence Interval|Geometric Mean
721228|NCT00307034|Secondary|Antibody Concentrations Against Diphteria (Anti-D) and Tetanus (Anti-T) Toxoids|Concentrations of antibodies are presented as geometric mean concentrations, expressed as international units per milliliter (IU/mL). Seroprotection status was defined as anti-diphteria and anti-tetanus toxoid antibody concentrations greater than or equal to (≥) the value of 0.1 IU/mL. This outcome concerns results for the Primary and Booster Phases of the study.|One month post-dose 2 (Month 3) administration, one month before (Month 9) and one month after (Month 10) the booster dose of Synflorix™ vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity concerning data were available.||IU/mL||95% Confidence Interval|Geometric Mean
721229|NCT00307034|Secondary|Antibody Concentrations Against Protein D (Anti-PD)|Anti-protein D concentrations are expressed as geometric mean concentrations (GMCs), in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).Seropositivity status was defined as Anti-PD antibody concentrations greater than or equal to (≥) the value of 100 EL.U/mL. This outcome concerns results for the Primary and Booster Phases of the study.|One month post-dose 2 or post-dose 3 (Month 3) administration, one month before (Month 9) and one month after (Month 10) the booster dose of Synflorix™ vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity concerning data were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
721230|NCT00307034|Secondary|Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes|Seropositivity status was defined as the opsonophacocytic activity against pneumococcal serotypes greater than or egual to (≥) the value of 8. The vaccine pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C,19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F).This outcome concerns results for the Primary and Booster Phases of the study.|One month post-dose 2 or post-dose 3 (Month 3) administration, one month before (Month 9) and one month after (Month 10) the booster dose of Synflorix™ vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity concerning data were available.||Titers||95% Confidence Interval|Geometric Mean
721248|NCT00307047|Secondary|Protocol Defined Stent Thrombosis Rate|"ST will be categorized as acute (≤ 1day), subacute (>1 day to ≤ 30 days) and late (>30 days) and will be defined as any of the following:
Clinical presentation of acute coronary syndrome with angiographic evidence of ST
In the absence of angiography, any unexplained death, or acute MI (S-T segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific S-T/T changes, and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis."|31-393 days|||Percentage of participants|||Number
721231|NCT00307034|Secondary|Antibody Concentrations Against Pneumococcal Serotypes|The vaccine pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C,19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL. This outcome concerns results for the Primary and Booster Phases of the study.|One month post-dose 2 or post-dose 3 (Month 3) administration, one month before (Month 9) and one month after (Month 10) the booster dose of Synflorix™ vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity concerning data were available.||μg/mL||95% Confidence Interval|Geometric Mean
721232|NCT00307034|Secondary|Number of Seroprotected Subjects Against Pneumococcal Serotypes|A seroprotected subject was defined as a subject who had anti-pneumococcal serotypes antibody concentrations greater than or equal to (≥) the threshold value of 0.20 micrograms per milliliter (μg/mL). The vaccine pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C,19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs).|One month before (Month 9) and one month after (Month 10) the booster dose of Synflorix™ vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity concerning data were available.||Subjects|||Number
721233|NCT00307034|Primary|Number of Seroprotected Subjects Against Pneumococcal Serotypes|A seroprotected subject was defined as a subject who had anti-pneumococcal serotypes antibody concentrations greater than or equal to (≥) the threshold value of 0.20 micrograms per milliliter (μg/mL). The vaccine pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C,19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs). The results presented for the Group 1 correspond to the primary outcome.|One month post-dose 2 (Month 3) administration of Synflorix™ vaccine|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity concerning data were available.||Subjects|||Number
721234|NCT00307047|Secondary|Ischemia Driven Target Lesion Failure (TLF)|Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).|3 years|||Percentage of participants|||Number
721235|NCT00307047|Secondary|Ischemia Driven Target Lesion Failure (TLF)|Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).|2 years|||Percentage of participants|||Number
721236|NCT00307047|Secondary|Ischemia Driven Target Lesion Failure (TLF)|Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).|270 days|||Percentage of participants|||Number
721237|NCT00307047|Secondary|Ischemia Driven Target Lesion Failure (TLF)|Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).|180 days|||Percentage of participants|||Number
721238|NCT00307047|Secondary|Ischemia Driven Target Lesion Failure (TLF)|Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).|30 days|||Percentage of participants|||Number
721239|NCT00307047|Secondary|Cardiac Death or Target Vessel MI Rate||3 years|||Percentage of participants|||Number
721240|NCT00307047|Secondary|Cardiac Death or Target Vessel MI Rate||2 years|||Percentage of participants|||Number
721241|NCT00307047|Secondary|Cardiac Death or Target Vessel MI Rate||1 year|||Percentage of participants|||Number
721242|NCT00307047|Secondary|Cardiac Death or Target Vessel MI Rate||270 days|||Percentage of participants|||Number
721243|NCT00307047|Secondary|Cardiac Death or Target Vessel MI Rate||180 days|||Percentage of participants|||Number
721244|NCT00307047|Secondary|Cardiac Death or Target Vessel MI Rate||30 days|||Percentage of participants|||Number
721245|NCT00307047|Secondary|Protocol Defined Stent Thrombosis Rate|"ST will be categorized as acute (≤ 1day), subacute (>1 day to ≤ 30 days) and late (>30 days) and will be defined as any of the following:
Clinical presentation of acute coronary syndrome with angiographic evidence of ST
In the absence of angiography, any unexplained death, or acute MI (S-T segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific S-T/T changes, and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis."|0-1123 days|||Percentage of participants|||Number
721246|NCT00307047|Secondary|Protocol Defined Stent Thrombosis Rate|"ST will be categorized as acute (≤ 1day), subacute (>1 day to ≤ 30 days) and late (>30 days) and will be defined as any of the following:
Clinical presentation of acute coronary syndrome with angiographic evidence of ST
In the absence of angiography, any unexplained death, or acute MI (S-T segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific S-T/T changes, and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis."|0-758 days|||Percentage of participants|||Number
721247|NCT00307047|Secondary|Protocol Defined Stent Thrombosis Rate|"ST will be categorized as acute (≤ 1day), subacute (>1 day to ≤ 30 days) and late (>30 days) and will be defined as any of the following:
Clinical presentation of acute coronary syndrome with angiographic evidence of ST
In the absence of angiography, any unexplained death, or acute MI (S-T segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific S-T/T changes, and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis."|0-393 days|||Percentage of participants|||Number
721291|NCT00307047|Secondary|Ischemia Driven Target Lesion Revascularization (TLR)|"Revascularization of a target lesion associated with any of the following:
positive functional ischemia study
ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study"|270 days|ITT population||percentage of participants|||Number
721249|NCT00307047|Secondary|Protocol Defined Stent Thrombosis Rate|"ST will be categorized as acute (≤ 1day), subacute (>1 day to ≤ 30 days) and late (>30 days) and will be defined as any of the following:
Clinical presentation of acute coronary syndrome with angiographic evidence of ST
In the absence of angiography, any unexplained death, or acute MI (S-T segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific S-T/T changes, and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis."|0-30 days|||Percentage of participants|||Number
721250|NCT00307047|Secondary|Definite + Probable Stent Thrombosis Rate Based on ARC Definition|"ARC: Academic Research Consortium-defines ST as a cumulative value at the different time points and with the different seperate time points. Time 0 is defined as the time point after the guiding catheter has been removed. Acute*: 0-24 hours post implantation Subacute*: >24 hours-30 days post Late†: 30 days-1 year post Very late stent thrombosis†: >1 year post
* Acute/subacute can also be replaced by early ST. Early ST (0-30 days) is currently used in the community.
† Including primary as well as secondary late ST; secondary late ST is after a target segment revascularization."|0-1123 days|||Percentage of participants|||Number
721251|NCT00307047|Secondary|Definite + Probable Stent Thrombosis Rate Based on ARC Definition|"ARC: Academic Research Consortium-defines ST as a cumulative value at the different time points and with the different seperate time points. Time 0 is defined as the time point after the guiding catheter has been removed. Acute*: 0-24 hours post implantation Subacute*: >24 hours-30 days post Late†: 30 days-1 year post Very late stent thrombosis†: >1 year post
* Acute/subacute can also be replaced by early ST. Early ST (0-30 days) is currently used in the community.
† Including primary as well as secondary late ST; secondary late ST is after a target segment revascularization."|0-758 days|||Percentage of participants|||Number
721252|NCT00307047|Secondary|Definite + Probable Stent Thrombosis Rate Based on ARC Definition|"ARC: Academic Research Consortium-defines ST as a cumulative value at the different time points and with the different seperate time points. Time 0 is defined as the time point after the guiding catheter has been removed. Acute*: 0-24 hours post implantation Subacute*: >24 hours-30 days post Late†: 30 days-1 year post Very late stent thrombosis†: >1 year post
* Acute/subacute can also be replaced by early ST. Early ST (0-30 days) is currently used in the community.
† Including “primary” as well as “secondary” late ST; “secondary” late ST is after a target segment revascularization."|0 -393 days|||Percentage of participants|||Number
721253|NCT00307047|Secondary|Definite + Probable Stent Thrombosis Rate Based on ARC Definition|"ARC: Academic Research Consortium-defines ST as a cumulative value at the different time points and with the different seperate time points. Time 0 is defined as the time point after the guiding catheter has been removed. Acute*: 0-24 hours post implantation Subacute*: >24 hours-30 days post Late†: 30 days-1 year post Very late stent thrombosis†: >1 year post
* Acute/subacute can also be replaced by early ST. Early ST (0-30 days) is currently used in the community.
† Including “primary” as well as “secondary” late ST; “secondary” late ST is after a target segment revascularization."|31-393 days|||Percentage of participants|||Number
721254|NCT00307047|Secondary|Definite + Probable Stent Thrombosis Rate Based on Academic Research Consortium (ARC) Definition|"ARC: Academic Research Consortium-defines ST as a cumulative value at the different time points and with the different seperate time points. Time 0 is defined as the time point after the guiding catheter has been removed. Acute*: 0-24 hours post implantation Subacute*: >24 hours-30 days post Late†: 30 days-1 year post Very late stent thrombosis†: >1 year post
* Acute/subacute can also be replaced by early ST. Early ST (0-30 days) is currently used in the community.
† Including “primary” as well as “secondary” late ST; “secondary” late ST is after a target segment revascularization."|0-30 days|||Percentage of participants|||Number
721255|NCT00307047|Secondary|Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)||3 years|||Percentage of participants|||Number
721256|NCT00307047|Secondary|Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)||2 years|||Percentage of participants|||Number
721257|NCT00307047|Secondary|Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)||1 year|||Percentage of participants|||Number
721258|NCT00307047|Secondary|Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)||270 days|||Percentage of participants|||Number
721259|NCT00307047|Primary|Ischemia Driven Target Lesion Failure (TLF)|Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).|1 year|||Percentage of participants|||Number
721260|NCT00307047|Secondary|Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)||180 days|||Percentage of participants|||Number
721261|NCT00307047|Secondary|Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)||30 days|||Percentage of participants|||Number
721262|NCT00307047|Secondary|All Cause Mortality||3 years|||Percentage of participants|||Number
721263|NCT00307047|Secondary|All Cause Mortality||2 years|||Percentage of participants|||Number
721264|NCT00307047|Secondary|All Cause Mortality||1 year|||Percentage of participants|||Number
721265|NCT00307047|Secondary|All Cause Mortality||270 days|||Percentage of participants|||Number
721266|NCT00307047|Secondary|All Cause Mortality||180 days|||Percentage of participants|||Number
721267|NCT00307047|Secondary|All Cause Mortality||30 days|||Percentage of participants|||Number
721268|NCT00307047|Secondary|All MI||3 years|||Percentage of participants|||Number
721269|NCT00307047|Secondary|All MI||2 years|||Percentage of participants|||Number
721270|NCT00307047|Secondary|All MI||1 year|||Percentage of participants|||Number
721271|NCT00307047|Secondary|All MI||270 days|||Percentage of participants|||Number
721272|NCT00307047|Secondary|All MI||180 days|||Percentage of participants|||Number
721273|NCT00307047|Secondary|All Myocardial Infarction (MI)||30 days|||Percentage of participants|||Number
721292|NCT00307047|Secondary|Ischemia Driven Target Lesion Revascularization (TLR)|"Revascularization of a target lesion associated with any of the following:
positive functional ischemia study
ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study"|180 days|ITT population||percentage of participants|||Number
721274|NCT00307047|Secondary|Acute Success (Clinical Procedure)|Successful delivery and deployment of the study stent or stents at the intended target lesion and successful withdrawal of the stent delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of major adverse cardiac event (MACE) during the hospital stay with a maximum of first seven days following the index procedure. In multiple lesion setting all lesions must meet clinical procedure success.|Acute: At time of index procedure|Clinical procedure success is computed per subject||Percentage of success|||Number
721275|NCT00307047|Secondary|Acute Success (Clinical Device)|Successful delivery and deployment of the first implanted study stent (in overlapping stent setting a successful delivery and deployment of the first and second study stents) at the intended target lesion and successful withdrawal of the stent delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable). Bailout subjects will be included as device success only if the above criteria for clinical device are met.|Acute: At time of index procedure|clinical device success is computed per lesion||Percent of success|||Number
721276|NCT00307047|Secondary|Ischemia Driven Major Adverse Cardiac Events (MACE)|Patients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR|3 years|||Percentage of participants|||Number
721277|NCT00307047|Secondary|Ischemia Driven Major Adverse Cardiac Events (MACE)|Patients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR|2 years|||Percentage of participants|||Number
721278|NCT00307047|Secondary|Ischemia Driven Major Adverse Cardiac Events (MACE)|Patients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR|1 years|||Percentage of participants|||Number
721279|NCT00307047|Secondary|Ischemia Driven Major Adverse Cardiac Events (MACE)|Patients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR|270 days|||Percentage of participants|||Number
721280|NCT00307047|Secondary|Ischemia Driven Major Adverse Cardiac Events (MACE)|Patients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR|180 days|||Percentage of participants|||Number
721281|NCT00307047|Secondary|Ischemia Driven Major Adverse Cardiac Events (MACE)|Patients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR|30 days|||Percentage of participants|||Number
721282|NCT00307047|Secondary|Ischemia Driven Target Vessel Revascularization (TVR)|"Revascularization of a lesion within the target vessel associated with any of the following:
positive functional ischemia study
ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study"|3 years|||percentage of participants|||Number
721283|NCT00307047|Secondary|Ischemia Driven Target Vessel Revascularization (TVR)|"Revascularization of a lesion within the target vessel associated with any of the following:
positive functional ischemia study
ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study"|2 years|||percentage of participants|||Number
721284|NCT00307047|Secondary|Ischemia Driven Target Vessel Revascularization (TVR)|"Revascularization of a lesion within the target vessel associated with any of the following:
positive functional ischemia study
ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study"|1 year|||percentage of participants|||Number
721285|NCT00307047|Secondary|Ischemia Driven Target Vessel Revascularization (TVR)|"Revascularization of a lesion within the target vessel associated with any of the following:
positive functional ischemia study
ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study"|270 days|||percentage of participants|||Number
721286|NCT00307047|Secondary|Ischemia Driven Target Vessel Revascularization (TVR)|"Revascularization of a lesion within the target vessel associated with any of the following:
positive functional ischemia study
ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study"|180 days|||percentage of participants|||Number
721287|NCT00307047|Secondary|Ischemia Driven Target Vessel Revascularization (TVR)|"Revascularization of a lesion within the target vessel associated with any of the following:
positive functional ischemia study
ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study"|30 days|||percentage of participants|||Number
721288|NCT00307047|Secondary|Ischemia Driven Target Lesion Revascularization (TLR)|"Revascularization of a target lesion associated with any of the following:
positive functional ischemia study
ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study"|3 years|ITT population.||percentage of participants|||Number
721289|NCT00307047|Secondary|Ischemia Driven Target Lesion Revascularization (TLR)|"Revascularization of a target lesion associated with any of the following:
positive functional ischemia study
ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study"|2 years|ITT population.||percentage of participants|||Number
721290|NCT00307047|Secondary|Ischemia Driven Target Lesion Revascularization (TLR)|"Revascularization of a target lesion associated with any of the following:
positive functional ischemia study
ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study"|1 year|ITT population.||percentage of participants|||Number
721302|NCT00307125|Secondary|Number of Participants With Evidence of Viral Replication of Epstein-Barr Virus (EBV)|Number of participants with positive viral replication of EBV within 12 month post treatment initiation. Measured by polymerase chain reaction (PCR) method. Evidence of EBV viral replication is indicative of active infection.|1 year post treatment initiation|Intent-to-treat||participants|||Number
721303|NCT00307125|Secondary|Number of Participants With Viral Replication of Cytomegalovirus (CMV)|Number of participants with viral replication of CMV within 12 month post treatment initiation. Measured by polymerase chain reaction (PCR) method. Evidence of viral replication is indicative of active CMV infection.|1 year post treatment initiation|Intent-to-treat||participants|||Number
721304|NCT00307125|Secondary|Number of Participants Experiencing Loss of Peritubular Capillary (PTC) C4d Staining on Kidney Biopsy|Number of participants with loss of PTC C4d staining on kidney (renal) biopsy within 12 months post treatment initiation. PTC C4d staining on biopsy indicates organ rejection.|1 year post treatment initiation|Intent-to-treat||participants|||Number
721305|NCT00307125|Secondary|Number of Participants Experiencing Biopsy-proven Post-Transplant Lymphoproliferative Disease (PTLD)|Number of participants with PTLD within 12 month post treatment initiation. Diagnosis of PTLD was made by B cell proliferation after therapeutic immunosuppression.|1 year post treatment initiation|Intent-to-treat||participants|||Number
721306|NCT00307125|Secondary|Number of Participants Experiencing Graft Loss 12 Months Post Treatment Initiation|Number of participants with graft loss, defined as the need for dialysis for greater than 30 days duration, allograft nephrectomy, or the decision to withdraw immunosuppression due to graft failure within 12 month post treatment initiation|1 year post treatment initiation|Intent-to-treat||participants|||Number
721307|NCT00307125|Secondary|Number of Deaths 12 Months Post Treatment Initiation|Number of participant deaths within 12 months post treatment initiation|12 months post treatment initiation|Intent-to-treat||participants|||Number
721308|NCT00307125|Primary|Number of Participants With 50 Percent (%) Decrease in Circulating Anti-Human Leukocyte Antigen (HLA) Antibodies|Number of participants with 50% decrease in circulating anti-HLA antibodies at any time within the first 12 months post kidney transplant by LuminexTM Beads Method. Luminex assays for quantitation and detection of cytokine and signal transduction proteins. Presence of circulating antibodies is indicative of the transplant recipient’s immune system responding to the transplanted organ as a foreign object or infection.|1 year post treatment initiation|Intent-to-treat||participants|||Number
721309|NCT00307125|Primary|During Screening Phase: Timing of Alloantibody Development|Data were analyzed for 653 participants from the screening phase of the study. Of these, 79 (12%) developed de novo HLA-antibodies (anti-HLA Ab). This outcome looks at the average length of time (interval) from post kidney transplant until development of alloantibody. Alloantibody is defined as an antibody produced following the introduction of an alloantigen into the system of an individual lacking that particular antigen. Alloantibodies are important mediators of acute and chronic rejection|During screening window of 3-60 months post kidney transplant|Screening sample||Months||Standard Deviation|Mean
721310|NCT00307125|Primary|During Screening Phase: Incidence of Alloantibody Development|Data were analyzed for 653 participants from the screening phase of the study. This outcome looked at the number of kidney transplant recipients that developed de novo HLA antibodies (anti-HLA Ab) post-transplant. Alloantibody is defined as an antibody produced following the introduction of an alloantigen into the system of an individual lacking that particular antigen. Alloantibodies are important mediators of acute and chronic rejection.|During screening window of 3-60 months post kidney transplant|Screening sample||participants|||Number
721311|NCT00307151|Secondary|Time From Randomization to Death|Results report 2nd percentile of time from randomization to death|Until date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009 - median follow-up 48 weeks and range 0 - 125 weeks; Coh II: October 27, 2010 - median follow-up 72 weeks and range from 0 to 204 weeks)|Analysis uses intent to treat population||Weeks||95% Confidence Interval|Number
721312|NCT00307151|Secondary|Time From Randomization to HIV-related Disease Progression or Death|HIV-related disease progression was defined as progression in WHO clinical stage from stage at entry or death. For subjects in WHO Stage IV at entry, disease progression was defined as death.|Until date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009 - median follow-up 48 weeks and range 0 - 125 weeks; Coh II: October 27, 2010 - median follow-up 72 weeks and range from 0 to 204 weeks)|Analysis uses intent to treat population||Weeks||95% Confidence Interval|Number
721313|NCT00307151|Secondary|Change in CD4 Percent From Entry to Week 48|Change was calculated as CD4 percent at week 48 minus entry CD4 percent (last CD4 percent before randomization date). Only subjects who reached 48 weeks of follow-up before DSMB decisions to unblind each Cohort were included in summary.|48 weeks if before date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009; Coh II: October 27, 2010)|Analysis uses intent to treat population. Change reported if subject followed at least 48 weeks before DSMB unblinding of results for each Cohort||Percent of CD4||95% Confidence Interval|Mean
721314|NCT00307151|Secondary|Number of Participants Developing New NRTI, NNRTI or PI-resistant Virus|Numbers of participants developing new NRTI, NNRTI or PI-resistant virus after reaching a virologic failure endpoint|Until date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009 - median follow-up 48 weeks and range 0 - 125 weeks; Coh II: October 27, 2010 - median follow-up 72 weeks and range from 0 to 204 weeks)|Results included for any participant who was a virologic failure as defined in secondary outcome 4 and who had results available at study entry and virologic failure.||participants|||Number
721315|NCT00307151|Secondary|Time From Start of Study Treatment to First New Grade >=3 Lab Abnormality, Sign or Symptom Occurring on Study Treatment|Safety events include lab abnormalities, signs or symptoms of grade 3 or higher. Events were graded according to the Division of AIDS Table for Grading Severity of Adult and Pediatric Adverse Events, Version 1.0. Events defined as new if first occurrence was after initiation of study treatment or if severity increased from entry and while on the NNRTI or PI component of study treatment.|On randomized NNRTI or PI component of study treatment and until date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009; Coh II: October 27, 2010)|Uses follow-up from start of NVP or LPV/r component of study treatment until component switched or date of DSMB decision to unblind results, whichever occurred first||Weeks||95% Confidence Interval|Number
721794|NCT00322049|Secondary|Incidence of Dengue Specific Symptoms|Percentage of subjects showing incidence of dengue specific symptoms during the 30-day follow-up period after vaccinations|30-day follow-up period after dose 1 and 2|||% of subjects with specified symptoms||95% Confidence Interval|Mean
721316|NCT00307151|Secondary|Time From Randomization to Virologic Failure|Virologic failure is defined as the earlier of a confirmed plasma HIV-1 RNA level that is <1 log10 copies/mL below the study entry value at 12 to 24 weeks after treatment is initiated OR a confirmed plasma HIV-1 RNA level >400 copies/mL at 24 weeks OR a confirmed viral rebound >4000 copies/mL after week 24 OR death.|Until date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009 - median follow-up 48 weeks and range 0 - 125 weeks; Coh II: October 27, 2010 - median follow-up 72 weeks and range from 0 to 204 weeks)|Analysis uses intent to treat population||Weeks||95% Confidence Interval|Number
721317|NCT00307151|Secondary|Percent of Participants Experiencing Virologic Failure|Virologic failure is defined as a confirmed plasma HIV-1 RNA level that is <1 log10 copies/mL below the study entry value at 12 to 24 weeks after treatment is initiated OR a confirmed plasma HIV-1 RNA level >400 copies/mL at 24 weeks OR death on or before 24 weeks. Results report percent of participants reaching a virologic failure endpoint by week 24 calculated using the Kaplan-Meier method.|Earlier of 24 weeks or date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009; Coh II: October 27, 2010)|Analysis uses intent to treat population.||Percent of participants|||Number
721318|NCT00307151|Secondary|Time From Randomization to Treatment Failure, Defined as Virologic Failure or Permanent Discontinuation of the Randomized NNRTI or PI Component of Study Treatment|Treatment failure is defined as a confirmed plasma HIV-1 RNA level that is <1 log10 copies/mL below the study entry value at 12 to 24 weeks after treatment is initiated OR a confirmed plasma HIV-1 RNA level >400 copies/mL at 24 weeks OR a confirmed viral rebound >4000 copies/mL after week 24 OR permanent discontinuation of the randomized NNRTI or PI component of study treatment for any reason including death.|Until date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009 - median follow-up 48 weeks and range 0 - 125 weeks; Coh II: October 27, 2010 - median follow-up 72 weeks and range from 0 to 204 weeks)|Analysis uses intent to treat population||Weeks||95% Confidence Interval|Number
721319|NCT00307151|Primary|Percent of Participants With Treatment Failure, Defined as a Confirmed Virologic Failure or Permanent Discontinuation of the Randomized NNRTI or PI Component of Study Treatment|Treatment failure is defined as a confirmed plasma HIV-1 RNA level that is <1 log10 copies/mL below the study entry value at 12 to 24 weeks after treatment is initiated OR a confirmed plasma HIV-1 RNA level >400 copies/mL at 24 weeks OR permanent discontinuation of the randomized NNRTI or PI component of study treatment at or prior to 24 weeks of treatment for any reason including death. Results report percent of participants reaching a treatment failure endpoint by week 24 calculated using the Kaplan-Meier method.|Earlier of 24 weeks or date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009; Coh II: October 27, 2010)|Analysis uses intent to treat population||Percent of participants|||Number
721320|NCT00307164|Secondary|Change in Creatine Kinase From Baseline (Week 48 - Baseline)||Baseline and Week 48|Intention to treat analysis with LOCF if week 48 creatine kinase data was missing and post-baseline creatine kinase was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT).||IU/L||Inter-Quartile Range|Median
721321|NCT00307164|Secondary|Change in Leukocytes From Baseline (Week 48 - Baseline)||Baseline and Week 48|Intention to treat analysis with LOCF if week 48 leukocyte data was missing and post-baseline leukocyte was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT).||cells*10^3/L||Inter-Quartile Range|Median
721322|NCT00307164|Secondary|Change in Hemoglobin From Baseline (Week 48 - Baseline)||Baseline and Week 48|Intention to treat analysis with LOCF if week 48 hemoglobin data was missing and post-baseline hemoglobin was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT).||g/dL||Inter-Quartile Range|Median
721323|NCT00307164|Secondary|Change in Fasting Triglycerides From Baseline (Week 48 - Baseline)||Baseline and Week 48|Intention to treat analysis with LOCF if week 48 fasting triglyceride data was missing and post-baseline fasting triglyceride was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT).||mg/dL||Inter-Quartile Range|Median
721324|NCT00307164|Secondary|Change in Fasting Low-density Lipoprotein (LDL) Cholesterol From Baseline (Week 48 - Baseline)||Baseline and Week 48|Intention to treat analysis with LOCF if week 48 fasting LDL data was missing and post-baseline fasting LDL was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT).||mg/dL||Inter-Quartile Range|Median
721325|NCT00307164|Secondary|Change in Fasting Non-HDL Cholesterol From Baseline (Week 48 - Baseline)||Baseline and Week 48|Intention to treat analysis with LOCF if week 48 fasting non-HDL data was missing and post-baseline fasting non-HDL was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF or due to associated triglyceride was >400 mg/dL. Subjects were stratified based on ART (d4T or AZT).||mg/dL||Inter-Quartile Range|Median
721326|NCT00307164|Secondary|Change in Fasting High-density Lipoprotein (HDL) Cholesterol From Baseline (Week 48 - Baseline)||Baseline and Week 48|Intention to treat analysis with LOCF if week 48 fasting HDL data was missing and post-baseline fasting HDL was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT).||mg/dL||Inter-Quartile Range|Median
721327|NCT00307164|Secondary|Change in Fasting Total Cholesterol From Baseline (Week 48 - Baseline)||Baseline and Week 48|Intention to treat analysis with LOCF if week 48 fasting total cholesterol was missing and post-baseline fasting total cholesterol was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT).||mg/dL||Inter-Quartile Range|Median
721328|NCT00307164|Secondary|Change in Fasting Glucose From Baseline (Week 48 - Baseline)||Baseline and Week 48|Intention to treat analysis with LOCF if week 48 fasting glucose was missing and post-baseline fasting glucose was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT).||mg/dL||Inter-Quartile Range|Median
721329|NCT00307164|Secondary|Change in Fasting Lactate From Baseline (Week 48 - Baseline)||Baseline and Week 48|Intention to treat analysis with LOCF if week 48 fasting lactate was missing and post-baseline fasting lactate was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT).||mmol/L||Inter-Quartile Range|Median
721330|NCT00307164|Secondary|Change in CD4+ Count From Baseline (Week 48 - Baseline)||Baseline and Week 48|Intention to treat analysis with LOCF if week 48 CD4+ data was missing and post-baseline data was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT).||cells/mm3||Inter-Quartile Range|Median
721331|NCT00307164|Secondary|HIV-1 RNA Level||At Week 48|Intention to treat analysis with all randomized subjects. Reduced sample size was due to missing data at week 48.||Participants|||Number
721332|NCT00307164|Secondary|Change in Limb Fat From Baseline (Week 24 - Baseline)|Limb fat was measured at baseline and visit week 24 using dual-energy x-ray absorptiometry (DEXA), and change from baseline to week 24 (week 24 - baseline) was estimated for the treatment groups.|Baseline and Week 24|Intention to treat analysis with LOCF if week 24 limb fat data was missing and post-baseline before week 24 limb fat observation was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT).||grams||Inter-Quartile Range|Median
721333|NCT00307164|Secondary|Number of Subjects Discontinuing Study Medication|Number of eligible subjects who discontinued study medication during the study period.|Through Week 48|Intention to treat analysis based on all subjects who started study treatment.||Participants|||Number
721334|NCT00307164|Secondary|Time to Safety Events (Signs/Symptoms or Laboratory Abnormalities)|Time to safety events (grade 3 [Severe] or 4 [life-threatening] sign/symptom or laboratory-based abnormality that is at least one grade higher than baseline) from study entry|Through Week 48|As-treated analysis with subjects stratified based on ART (d4T or AZT).||weeks||Inter-Quartile Range|Median
721335|NCT00307164|Primary|Change in Limb Fat (g) From Baseline|Limb fat was measured at baseline and visit week 48 using dual-energy x-ray absorptiometry (DEXA), and change from baseline to week 48 (week 48 - baseline) was estimated for the treatment groups.|Baseline and Week 48|Intention to treat analysis with last observation carried forward (LOCF) if week 48 limb fat data was missing and post-baseline limb fat was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT).||grams||Inter-Quartile Range|Median
721336|NCT00308516|Secondary|Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death|Length of time, in months, that patients were alive from their first date of protocol treatment until death.|24 months||||||
721337|NCT00308516|Primary|Disease-Free Survival (DFS), The Proportion of Patients Predicted to be Alive Without Evidence of Disease Recurrence 24 Months After Completion of Protocol Treatment|The Proportion of Patients Predicted to be Alive Without Evidence of Disease Recurrence 24 Months After Completion of Protocol Treatment|24 months|||percentage of participants||95% Confidence Interval|Number
721338|NCT00308555|Primary|Disposition Kinetics of Morphine and Oxycodone Before and After Cannabis Use|Pharmacokinetics are measured on Day 1, prior to cannabis use, and again on Day 5, following cannabis use on Days 2, 3, and 4.|Day 1, Day 5|The number was determined by the number of participants completing both Day 1 and Day 5 procedures.||Geometric Mean Ratio||95% Confidence Interval|Number
721339|NCT00308581|Secondary|CRP Level at Endpoint (Last Visit) in the Randomized Maintenance Phase|High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L. Endpoint is the visit when the last observation was taken, either at week 26 or at a visit before in case of early dropout.|Last visit on or before Week 26|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)||mg/L||Inter-Quartile Range|Median
721340|NCT00308581|Secondary|CRP Level at Week 26 in the Randomized Maintenance Phase|High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.|Week 26|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)||mg/L||Inter-Quartile Range|Median
721341|NCT00308581|Secondary|CRP Level at Week 24 in the Randomized Maintenance Phase|High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.|Week 24|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)||mg/L||Inter-Quartile Range|Median
721342|NCT00308581|Secondary|CRP Level at Week 22 in the Randomized Maintenance Phase|High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.|Week 22 (optional measurement)|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements, measurements are optional)||mg/L||Inter-Quartile Range|Median
721343|NCT00308581|Secondary|CRP Level at Week 20 in the Randomized Maintenance Phase|High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.|Week 20|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)||mg/L||Inter-Quartile Range|Median
721344|NCT00308581|Secondary|CRP Level at Week 18 in the Randomized Maintenance Phase|High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.|Week 18 (optional measurement)|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements, measurements are optional)||mg/L||Inter-Quartile Range|Median
721345|NCT00308581|Secondary|CRP Level at Week 16 in the Randomized Maintenance Phase|High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.|Week 16|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)||mg/L||Inter-Quartile Range|Median
721346|NCT00308581|Secondary|CRP Level at Week 14 in the Randomized Maintenance Phase|High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.|Week 14 (optional measurement)|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements, measurements are optional)||mg/L||Inter-Quartile Range|Median
721347|NCT00308581|Secondary|CRP Level at Week 12 in the Randomized Maintenance Phase|High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.|Week 12|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)||mg/L||Inter-Quartile Range|Median
721915|NCT00322621|Secondary|Number of Participants Discontinuing in Maintenance / Rescue Phase||Baseline (Week 8) to Week 34|Participants in Maintenance / Rescue Phase (beyond Week 8 through Week 34)||participants|||Number
721348|NCT00308581|Secondary|CRP Level at Week 10 in the Randomized Maintenance Phase|High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.|Week 10 (optional measurement)|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements, measurements are optional)||mg/L||Inter-Quartile Range|Median
721349|NCT00308581|Secondary|CRP Level at Week 8 in the Randomized Maintenance Phase|High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.|Week 8|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)||mg/L||Inter-Quartile Range|Median
721350|NCT00308581|Secondary|CRP Level at Week 6 of the Induction Phase|High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.|Week 6|ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements)||mg/L||Inter-Quartile Range|Median
721351|NCT00308581|Secondary|CRP Level at Week 4 of the Induction Phase|High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.|Week 4|ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements)||mg/L||Inter-Quartile Range|Median
721352|NCT00308581|Secondary|CRP Level at Week 2 of the Induction Phase|High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.|Week 2|ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements)||mg/L||Inter-Quartile Range|Median
721353|NCT00308581|Secondary|C - Reactive Protein (CRP) Level at Baseline (Week 0) of the Induction Phase|High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.|Week 0|ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements)||mg/L||Inter-Quartile Range|Median
721354|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 26 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).|Week 26|ITTR population taking steroids at baseline||participants|||Number
721355|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 24 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).|Week 24|ITTR population taking steroids at baseline||participants|||Number
721356|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 22 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).|Week 22|ITTR population taking steroids at baseline||participants|||Number
721357|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 20 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).|Week 20|ITTR population taking steroids at baseline||participants|||Number
721358|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 18 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).|Week 18|ITTR population taking steroids at baseline||participants|||Number
721359|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 16 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).|Week 16|ITTR population taking steroids at baseline||participants|||Number
721360|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 14 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).|Week 14|ITTR population taking steroids at baseline||participants|||Number
721361|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 12 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).|Week 12|ITTR population taking steroids at baseline||participants|||Number
721362|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 10 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).|Week 10|ITTR population taking steroids at baseline||participants|||Number
721363|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 26 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Remission is defined as CDAI score ≤ 150.|Week 26|ITTR population taking steroids at baseline||participants|||Number
721364|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 24 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Remission is defined as CDAI score ≤ 150.|Week 24|ITTR population taking steroids at baseline||participants|||Number
721365|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 22 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Remission is defined as CDAI score ≤ 150.|Week 22|ITTR population taking steroids at baseline||participants|||Number
721366|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 20 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Remission is defined as CDAI score ≤ 150.|Week 20|ITTR population taking steroids at baseline||participants|||Number
721367|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 18 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Remission is defined as CDAI score ≤ 150.|Week 18|ITTR population taking steroids at baseline||participants|||Number
721368|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 16 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Remission is defined as CDAI score ≤ 150.|Week 16|ITTR population taking steroids at baseline||participants|||Number
721369|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 14 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Remission is defined as CDAI score ≤ 150.|Week 14|ITTR population taking steroids at baseline||participants|||Number
721370|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 12 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Remission is defined as CDAI score ≤ 150.|Week 12|ITTR population taking steroids at baseline||participants|||Number
721371|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 10 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Remission is defined as CDAI score ≤ 150.|Week 10|ITTR population taking steroids at baseline||participants|||Number
721372|NCT00308581|Other Pre-specified|Time to Loss of Response (CDAI Score > 150 and Minimum Increase in CDAI of 70) After Week 6|Median time to loss of response in the maintenance period (from Kaplan-Meier analysis); range is time of first event to time of last event. Loss of response is defined as both a CDAI score > 150 points and a minimum increase in CDAI of 70 points versus Week 6 at two consecutive visits.|Week 6 to Week 26|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)||days||Full Range|Median
721373|NCT00308581|Secondary|Change From Baseline in CDAI Score at Week 26 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Week 26|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)||points on a scale||Standard Deviation|Mean
721374|NCT00308581|Secondary|Change From Baseline in CDAI Score at Week 24 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Week 24|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)||points on a scale||Standard Deviation|Mean
721375|NCT00308581|Secondary|Change From Baseline in CDAI Score at Week 22 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Week 22|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)||points on a scale||Standard Deviation|Mean
721376|NCT00308581|Secondary|Change From Baseline in CDAI Score at Week 20 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Week 20|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)||points on a scale||Standard Deviation|Mean
721377|NCT00308581|Secondary|Change From Baseline in CDAI Score at Week 18 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Week 18|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)||points on a scale||Standard Deviation|Mean
721378|NCT00308581|Secondary|Change From Baseline in CDAI Score at Week 16 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Week 16|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)||points on a scale||Standard Deviation|Mean
721379|NCT00308581|Secondary|Change From Baseline in CDAI Score at Week 14 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Week 14|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)||points on a scale||Standard Deviation|Mean
721380|NCT00308581|Secondary|Change From Baseline in CDAI Score at Week 12 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Week 12|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)||points on a scale||Standard Deviation|Mean
721381|NCT00308581|Secondary|Change From Baseline in CDAI Score at Week 10 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Week 10|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)||points on a scale||Standard Deviation|Mean
721446|NCT00309387|Secondary|Number of Participants Showing Development or Progression of Nuclear Lens Opacities|number of participants with a 1.5 U increase in nuclear opalescence from baseline in at least one eligible eye during follow-up|at yearly intervals from baseline for approximately ten years|intention to treat||participants|||Number
721382|NCT00308581|Secondary|Change From Baseline in CDAI Score at Week 8 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Week 8|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)||points on a scale||Standard Deviation|Mean
721383|NCT00308581|Secondary|Change From Baseline in CDAI Score at Week 6 of the Induction Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Week 6|ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements)||points on a scale||Standard Deviation|Mean
721384|NCT00308581|Secondary|Change From Baseline in CDAI Score at Week 4 of the Induction Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Week 4|ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements)||points on a scale||Standard Deviation|Mean
721385|NCT00308581|Secondary|Change From Baseline in CDAI Score at Week 2 of the Induction Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Week 2|ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements)||points on a scale||Standard Deviation|Mean
721386|NCT00308581|Secondary|CDAI Score at Week 26 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 26|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)||points on a scale||Standard Deviation|Mean
721387|NCT00308581|Secondary|CDAI Score at Week 24 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 24|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)||points on a scale||Standard Deviation|Mean
721388|NCT00308581|Secondary|CDAI Score at Week 22 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 22|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)||points on a scale||Standard Deviation|Mean
721389|NCT00308581|Secondary|CDAI Score at Week 20 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 20|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)||points on a scale||Standard Deviation|Mean
721390|NCT00308581|Secondary|CDAI Score at Week 18 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 18|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)||points on a scale||Standard Deviation|Mean
721391|NCT00308581|Secondary|CDAI Score at Week 16 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 16|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)||points on a scale||Standard Deviation|Mean
721392|NCT00308581|Secondary|CDAI Score at Week 14 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 14|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)||points on a scale||Standard Deviation|Mean
721393|NCT00308581|Secondary|CDAI Score at Week 12 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 12|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)||points on a scale||Standard Deviation|Mean
721394|NCT00308581|Secondary|CDAI Score at Week 10 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 10|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)||points on a scale||Standard Deviation|Mean
721395|NCT00308581|Secondary|CDAI Score at Week 8 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 8|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)||points on a scale||Standard Deviation|Mean
721396|NCT00308581|Secondary|CDAI Score at Week 6 of the Induction Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 6|ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements)||points on a scale||Standard Deviation|Mean
721397|NCT00308581|Secondary|CDAI Score at Week 4 of the Induction Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 4|ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements)||points on a scale||Standard Deviation|Mean
721398|NCT00308581|Secondary|CDAI Score at Week 2 of the Induction Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 2|ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements)||points on a scale||Standard Deviation|Mean
721399|NCT00308581|Secondary|Remission Status With Remission Defined as CDAI Score ≤ 150 in the Randomized Maintenance Phase|Remission is defined as CDAI score ≤ 150. The CDAI score is used to quantify the symptoms with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 26|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase||participants|||Number
721400|NCT00308581|Secondary|Remission Status With Remission Defined as CDAI Score ≤ 150 in the Induction Phase|Remission is defined as CDAI score ≤ 150. The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 6|ITTI population: subjects who received at least one dose of study drug in the induction phase||participants|||Number
721401|NCT00308581|Secondary|Response Status With Response Defined as at Least 70 Points Reduction in CDAI Score in the Randomized Maintenance Phase|Response is defined as at least 70 points reduction in CDAI score. The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Week 26|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase||participants|||Number
721402|NCT00308581|Secondary|Response Status With Response Defined as at Least 70 Points Reduction in CDAI Score in the Induction Phase|Response is defined as at least 70 points reduction in CDAI score. The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Week 6|ITTI population: all subjects who received at least one dose of study drug in the induction phase||participants|||Number
721403|NCT00308581|Secondary|Response Status With Response Defined as at Least 100 Point Decrease in CDAI Score From Baseline in the Randomized Maintenance Phase|Response is defined as at least 100 point decrease in CDAI score from baseline. The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Week 26|Intent-to-treat Randomized Maintenance Phase (ITTR) population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase||participants|||Number
721404|NCT00308581|Primary|Response Status With Response Defined as at Least 100 Point Decrease in Crohn's Disease Activity Score (CDAI Score) From Baseline in the Induction Phase|"Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score) from baseline, otherwise there is a non-response.
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity."|Baseline to Week 6|Intent-to-treat Induction Phase (ITTI) population: subjects who received at least one dose of study drug in the induction phase||participants|||Number
721405|NCT00308620|Secondary|Change in Immune Activation Assessed by Flow Cytometry Analysis From Baseline to 8 Weeks|The Change in the percentages of CD38+ HLA-DR+ CD8 and CD4 memory T cells from baseline to 8 weeks.|8 weeks|Analysis of Chloroquine arms is pooled.||percentage change||Full Range|Median
721406|NCT00308620|Primary|HIV Viral Load Change|HIV-1 viral load change between baseline and 8 weeks|baseline and 8 weeks|||log10 copies/mL||Standard Deviation|Log Mean
721407|NCT00308711|Secondary|Days in Hospital for Mother and Neonate|Duration of stay in hospital for mother and neonate starting with insertion of the study drug and ending with discharge from the hospital.|10 days|||days||Standard Deviation|Mean
721408|NCT00308711|Secondary|Duration of Stay in Minutes in Labor and Delivery Suite|Minutes in Labor and Delivery (L & D) suite starting from insertion of the study drug to discharge from L & D to post partum care.|5760 minuts|||minutes||Standard Deviation|Mean
721409|NCT00308711|Secondary|Minutes to Rupture of Membranes (ROM)|Interval from study drug insertion to ROM.|2880 minutes|||minutes||95% Confidence Interval|Median
721410|NCT00308711|Secondary|Minutes to Onset of Active Labor|Interval from insertion of study drug to onset of active labor, defined as at least three contractions in a ten-minute period of at least moderate intensity and resulting in cervical change such as dilatation or effacement; OR at least 4 cm cervical dilatation achieved after progressive change in dilatation.|2880 minutes|||minutes||Standard Deviation|Mean
721447|NCT00309387|Primary|Number of Participants Showing Development or Progression of Age-related Cataract or Undergoing Cataract Surgery During Follow-up|number of participants in whom any of the following occur in at least one eligible eye during follow-up: cataract surgery; nuclear opacity: a 1.5 U increase in opalescence from baseline; cortical opacity: a 10% increase in area within a standard 5 mm circle area of the lens from baseline; posterior subcapsular opacity: a 5% increase in area within a standard 5 mm circle area of the lens from baseline.|at yearly intervals from baseline for approximately ten years|Intention to treat analysis||participants|||Number
721411|NCT00308711|Secondary|Percentage of Participants With Cervical Ripening Success Based On Modified Bishop Score (mBS) 12 Hours After Administration of Vaginal Insert|Measured the percentage of participants who achieved success on the mBS. This composite score is based on the mBS and vaginal delivery and it is measured 12 hours after insertion of the study drug. The mBS has a score of 0 when the cervix is not ripe and a score of 12 when completely ripened. The 12 hour score is compared to baseline. Using the mBS, assess at 12 hours whether each subject has met any of the following three criteria: 1) has improved (increased) the mBS by at least 3 points from baseline; 2) has reached a score of at least 6 on the mBS; or 3) has acheived a vaginal delivery.|12 hours|||Percentage of Participants|||Number
721412|NCT00308711|Secondary|Percentage of Participants With Pre-Delivery Oxytocin Use|Incidence in each treatment group of need for oxytocin for pre-delivery induction or augmentation of labor.|2880 minutes|This analysis included all participants exposed to study drug and for whom there was data available regarding whether oxytocin was used pre-delivery.||Percentage of participants|||Number
721413|NCT00308711|Secondary|Percentage of Participants With Maternal/Fetal, Maternal (Post-Partum), and Neonatal Adverse Events|"This outcome reports the percentage of adverse events in each treatment arm spontaneously reported or observed during the study. The intrapartum period (mother is still pregnant) is called the Maternal/Fetal period; once the baby has been born, adverse events are assessed separately for the mother (Post Partum) and the baby (Neonatal). The number of adverse events was assessed separately for each of the three periods."|96 hours|Analysis was based on intention to treat, i.e., all subjects who had the insert placed in the vagina.||Percentage of participants|||Number
721414|NCT00308711|Primary|Percentage of Participants With a Cesarean Section Delivery|Percentage of participants with cesarean delivery after study drug was administered. There is no set assessment time or date as the woman's labor may last hours or days.|2880 minutes|||Percentage of participants|||Number
721415|NCT00308711|Primary|Minutes From Drug Insertion to Vaginal Delivery|Interval between time/date of insertion of study drug and time/date of neonate birth. This is a time-to-event analysis, there is no set time for the assessment. The endpoint occurs when the baby is born. 48 hours can be used as an approximate interval by which time most of the babies have been delivered.|2880 minutes|This analysis is for time to vaginal delivery (interval from insertion of study drug into the vagina to the delivery of the neonate); patients delivered by cesarean section were censored from this time-to-event analysis using the longest interval for all participants from insertion of study drug to cesarean section delivery of neonate.||minutes||95% Confidence Interval|Median
721416|NCT00308737|Primary|FEV1 Decrease of ≥ 15% From Baseline Value at Last Measurement for TI vs Usual Care|FEV1 decrease of ≥ 15% from Baseline value at last measurement|Baseline to Month 24|Intention to Treat (ITT)||Participants|||Number
721417|NCT00308737|Secondary|Change in Weight From Baseline at Month 24|Change from baseline in weight at Month 24|Baseline to Month 24|Safety population at Month 24||kilograms||Standard Deviation|Mean
721418|NCT00308737|Secondary|Change From Baseline in Glycated Hemoglobin A1c (HbA1c) at Last Measurement for TI vs Usual Care|Change from baseline in HbA1c at last measurement|Baseline to Month 24|Intention to treat (ITT) with last observation carried forward (LOCF)||percentage||Standard Deviation|Mean
721419|NCT00308737|Secondary|Hemoglobin-Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLco) Decrease of >3 ml/Min/mmHg From Baseline Value at Last Measurement|Hemoglobin-corrected DLco decrease of >3 ml/min/mmHg from baseline value at last measurement|Baseline to Month 24|participants in ITT population with available data||Participants|||Number
721420|NCT00308737|Secondary|Hemoglobin-Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLco) Decrease of ≥ 15% From Baseline Value at Last Measurement|Hemoglobin-corrected DLco decrease of ≥ 15% from baseline value at last measurement|Baseline to Month 24|participants in ITT population with available data||Participants|||Number
721421|NCT00308737|Secondary|Total Lung Capacity (TLC) Decrease of ≥ 15% From Baseline Value at Last Measurement|TLC Decrease of ≥ 15% from Baseline Value at Last Measurement|Baseline to Month 24|participants in ITT population with available data||Participants|||Number
721422|NCT00308737|Secondary|Forced Vital Capacity (FVC) Decrease of ≥ 15% From Baseline Value at Last Measurement|FVC Decrease of ≥15% from Baseline Value at Last Measurement|Baseline to Month 24|participants in ITT population with available data||participants|||Number
721423|NCT00308737|Secondary|Change From Baseline to Month 24 in Hemoglobin Corrected DLco by MMRM|Change from baseline to Month 24 in hemoglobin-corrected DLco by MMRM|Baseline to Month 24|participants in ITT population with available data||mL/min/mmHg||Standard Deviation|Mean
721424|NCT00308737|Secondary|Change From Baseline to Month 24 in Total Lung Capacity (TLC) by MMRM|Change from baseline to Month 24 in TLC by MMRM|Baseline to Month 24|participants in ITT population with available data||liters||Standard Deviation|Mean
721425|NCT00308737|Secondary|Change From Baseline to Month 24 in Forced Vital Capacity (FVC) by MMRM|Change from Baseline to Month 24 in FVC by MMRM|Baseline to Month 24|Intention to Treat (ITT)||liters||Standard Deviation|Mean
721426|NCT00308737|Secondary|Change From Baseline to Last Measurement in FEV1 for TI vs Usual Care|Change from Baseline to last measurement(Month 24) in FEV1|Baseline to Month 24|Intention to Treat (ITT) with Last Observation Carried Forward (LOCF)||liters||95% Confidence Interval|Least Squares Mean
721427|NCT00308737|Primary|Change From Baseline to Month 24 in Forced Expiratory Volume in 1 Second (FEV1) by MMRM for TI vs Usual Care|Change from Baseline to End of Study in FEV1 by MMRM|Baseline to Month 24|Intention to Treat (ITT)||liters||Standard Deviation|Mean
721428|NCT00308997|Secondary|Clinical Global Improvement (CGI)Improvement|"CGI score assessed after 15 sessions, 16 minutes per session, of both right superior temporal and left superior temporal gyrus sites using either rTMS or sham stimulation (3 weeks). For patients dropping out of the trial prematurely, last-observation-carried-forward data were used for this outcome variable. The range for this score is from 1 to 7.
Lower scores correspond to greater improvement"|After 15 sessions of rTMS|Subjects who did not complete the intervention were excluded from the analysis||units on a scale||Standard Deviation|Mean
721448|NCT00309452|Secondary|Economic Measures Including Service Use, Cost of Care and Forensic Data.|Total annual cost per patient|every 6 months|||dollars||Standard Error|Mean
721449|NCT00309452|Secondary|Medication (Including Metabolic) Side Effects||every 6 months|data no collected|||||
721450|NCT00309452|Secondary|Subjects Who Committed Self-harm and Violence|The number of subjects who committed an act of self-harm or violence. This data was collected at 12 months.|12 months|This data was collected, numbers reflect actual data.||participants|||Number
721429|NCT00308997|Secondary|Change in Total Auditory Hall Rating Scale (AHRS) Score|"Total AHRS score assessed after 15 sessions, 16 minutes per session, of both right superior temporal and left superior temporal gyrus sites using either rTMS or sham stimulation (3 weeks). For patients dropping out of the trial prematurely, last-observation-carried-forward data were used for this outcome variable. The score range is from 0-42. This is reported as a difference score and a higher score is an improvement.
Total AHRS score is measured as change relative baseline (i.e., baseline minus endpoint). Larger (positive) scores correspond to greater improvement."|After 15 sessions of rTMS|Subjects who did not complete the intervention were excluded from the analysis||units on a scale||Standard Deviation|Mean
721430|NCT00308997|Secondary|Change in Hallucination Frequency|"AHRS frequency scale score assessed after 15 sessions, 16 minutes per session, of both right superior temporal and left superior temporal gyrus sites using either rTMS or sham stimulation (3 weeks). For patients dropping out of the trial prematurely, last-observation-carried-forward data were used for this outcome variable. The hallucination frequency range is from 0-9. The scores reported are difference scores, and an improvement is a higher score.
Hallucination frequency is one of the variables incorporated into the AHRS (Auditory Hallucinations Rating Scale). The score is measured as change relative to baseline (i.e., baseline minus endpoint). Larger (positive) scores correspond to greater improvement."|After 15 sessions of rTMS|Subjects who did not complete the intervention were excluded from the analysis||units on a scale||Standard Deviation|Mean
721431|NCT00308997|Primary|Hallucination Change Score (HCS)|"HCS score assessed after 15 sessions, 16 minutes per session, delivered to both right superior temporal and left superior temporal gyrus sites using either rTMS or sham stimulation. For patients dropping out of the trial prematurely, last-observation-carried-forward data were used for this outcome variable.
HCS was anchored at 0 (corresponding to no AVHs), 10 (no change in hallucination severity) and 20 (AVHs twice as severe as baseline). Lower scores correspond to greater improvement"|After 15 sessions of rTMS|Subjects who did not complete the intervention were excluded from the analysis||units on a scale||Standard Deviation|Mean
721432|NCT00308997|Primary|Hallucination Change Score - Left (HCS-left)|"HCS score for participants assessed after 5 sessions, 16 minutes per session, who received either rTMS or sham stimulation delivered to the left superior temporal gyrus.
HCS was anchored at 0 (corresponding to no AVHs), 10 (no change in hallucination severity) and 20 (AVHs twice as severe as baseline). Lower scores correspond to greater improvement"|After 5 sessions of rTMS|Subjects who did not complete the intervention were not included in the analysis||units on a scale||Standard Deviation|Mean
721433|NCT00308997|Primary|Hallucination Change Score - Right (HCS-right)|"HCS score for participants assessed after 5 sessions, 16 minutes per session, who received either rTMS or sham stimulation delivered to the right superior temporal gyrus.
HCS was anchored at 0 (corresponding to no AVHs), 10 (no change in hallucination severity) and 20 (AVHs twice as severe as baseline). Lower scores correspond to greater improvement"|After 5 sessions of rTMS|Subjects who did not complete the intervention were not analyzed||units on a scale||Standard Deviation|Mean
721434|NCT00309244|Secondary|Severe Hypoglycemia Event Rate|Number of Severe Hypoglycemic Events/Total Subject Exposure Time (in months)|52 Weeks|Safety Population||Number of events/100 subject-months|||Number
721435|NCT00309244|Secondary|Total Hypoglycemia Event Rate|Number of Hypoglycemic Events/Total Subject Exposure Time (in months)|52 Weeks|Safety Population||Number of events/subject-month|||Number
721436|NCT00309244|Secondary|Incidence of Severe Hypoglycemia|"Severe hypoglycemia occurs when all 3 of the following occur simultaneously:
Subject requires the assistance of another person;
Subject exhibits at least 1 cognitive neurological symptom (memory loss, confusion, uncontrollable behavior, irrational behavior, unusual difficulty in awakening, seizure, loss of consciousness);
Measured BG is ≤ 49 mg/dL (2.7 mmol/L), or, in the absence of a BG measurement, clinical symptoms are reversed by oral carbohydrates, sc glucagon or intravenous glucose administration; OR,
Measured BG is ≤ 36 mg/dL (2.0 mmol/L) with or without symptoms."|52 Weeks|Safety Population||percentage of participants|||Number
721437|NCT00309244|Secondary|Incidence of Total Hypoglycemia|Defined as hypoglycemic symptoms that are relieved with carbohydrate intake or blood glucose measurement <= 63 mg/dL, regardless of symptoms.|52 Weeks|Safety Population||percentage of participants|||Number
721438|NCT00309244|Secondary|Number of Subjects Achieving Week 52 HbA1c Levels Less Than or Equal to 7.0%||Week 52|Intention to treat (ITT); participants with available data at baseline and Week 52.||participants|||Number
721439|NCT00309244|Secondary|Change From Baseline in Fasting Plasma Glucose to Week 52||Baseline to Week 52|Intention to treat (ITT) population; participants with available data at baseline and Week 52.||milligrams per deciliter||Standard Error|Least Squares Mean
721440|NCT00309244|Secondary|Change From Baseline in Weight to Week 52||Baseline to Week 52|Intention to treat (ITT) population; participants with available data at baseline and Week 52.||kilogram||Standard Error|Least Squares Mean
721441|NCT00309244|Primary|Change From Baseline in HbA1c to Week 52||Baseline to Week 52|Intention to treat (ITT) with Last Observation Carried Forward (LOCF); participants with available data at baseline and post-baseline.||percent||Standard Error|Least Squares Mean
721442|NCT00309387|Secondary|Number of Participants With a Decrease in Visual Acuity|Number of participants with a decrease in best corrected visual acuity score from baseline of > 15 letters in at least one eligible eye during follow-up|at 6 month intervals from baseline for approximately 10 yrs|intention to treat||participants|||Number
721443|NCT00309387|Secondary|Number of Participants Undergoing Cataract Surgery|number of participants undergoing cataract surgery in at least one eligible eye during follow-up|at 6 month intervals from baseline for approximately 10 yrs|intention to treat||participants|||Number
721444|NCT00309387|Secondary|Number of Participants Showing Development or Progression of Posterior Subcapsular Opacities|Number of participants with a 5% increase in area of posterior subcapsular opacity within a standard central 5 mm circle of the lens from baseline in at least one eligible eye during follow-up|at yearly intervals from baseline for approximately ten years|intention to treat||participants|||Number
721445|NCT00309387|Secondary|Number of Participants Showing Development or Progression of Cortical Lens Opacities|Number of participants with a 10% increase in area of cortical opacity within a standard central 5 mm circle of the lens from baseline in at least one eligible eye during follow-up|at yearly intervals from baseline for approximately ten years|intention to treat||participants|||Number
721488|NCT00310310|Other Pre-specified|Outcome Expectation|"Social-cognitive theory (SCT) measure
1= Not at all important 5= Extremely important 6= Not applicable"|1 month|||units on a scale||Standard Deviation|Mean
721451|NCT00309452|Secondary|Substance Use||every 6 months|This was not a planned primary or secondary outcome in our analysis (though collected at baseline) and because of significant attrition we did not report on this outcome despite having phone call f/u data on other outcomes. We did not believe phone reports on this outcome would produce reliable data.|||||
721452|NCT00309452|Secondary|Adherence- in Contact With Mental Health Services|Number of participants in contact with mental health services. Collected via self-report.|1 year|Patients were lost to follow up. 15 subjects in the Treatment as Usual arm, and 15 subjects in the STEP care arm.||participants|||Number
721453|NCT00309452|Secondary|Treatment Satisfaction||every 6 months|Data was not collected|||||
721454|NCT00309452|Secondary|Vocationally Engaged||1 year after enrollment|20 subjects from the treatment as usual arm were lost to follow-up. 12 subjects from STEP Care arm were lost to follow up.||participants|||Number
721455|NCT00309452|Secondary|Quality of Life- Heinrich's Quality of Life Scale|"The Quality of Life Scale (QLS) is a 21-item scale rated from a semistructured interview providing information on symptoms and functioning during the preceding 4 weeks. Each item is rated on a seven point scale, and a higher score reflects normal or unimpaired functioning. The range is from 0 to 126.
The score reflected is a change from baseline. Total score at 12 months minus total score at baseline. A positive score indicates better mental health."|12 months|||units on a scale||Standard Deviation|Mean
721456|NCT00309452|Secondary|Overall Functioning- Global Assessment of Functioning|"The Global Assessment of Functioning (GAF) is a numeric scale (1 through 100) used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of adults, e.g., how well or adaptively one is meeting various problems-in-living. A higher score indicates better functioning.
The score reported is a change from baseline. The change was calculated as score at 12 months minus score from baseline. A positive score indicates higher functioning."|12 months|||units on a scale||Standard Deviation|Mean
721457|NCT00309452|Secondary|Relapse|Data was not collected, instead Hospitalization (primary outcome) was used as a proxy|every 6 months||||||
721458|NCT00309452|Primary|Number of Patients Hospitalized||1 year after enrollment|||participants|||Number
721459|NCT00309465|Primary|Primary: Preoperative Fasting Blood Sugar Upon Arrival at the Hospital Prior to Surgery|Venous blood glucose values were obtained in the preoperative nursing unit. Blood glucose values were analyzed for achievement of target 100-179 mg/dl range and extended 80-249 mg/dl range. Analyses were by intention to treat.|Day 1|Percentage of subjects that achieved preoperative blood glucose value of 100-179 mg/dl and 80-249 mg/dl. Analyses were by intention to treat.||Percentage of subjects|||Number
721460|NCT00309608|Secondary|Fasting Blood Plasma Glucose Level (FPG) Change From Baseline at Week 12|This change from baseline reflects the Week 12 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 12|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.||mg/dL||Standard Error|Mean
721461|NCT00309608|Secondary|Percentage of Patients With HbA1c<=7.0% at Week 12|Descriptive calculation of Patients with HbA1c <= 7.0% at Week 12.|week 12|This population includes the Full Analysis Set (FAS). Last observation carried forward (LOCF) was used as the imputation rule.||Percentage of Patients|||Number
721462|NCT00309608|Primary|HbA1c Change From Baseline at Week 12|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the HbA1c percent baseline value. Means are treatment adjusted for baseline HbA1c.|Baseline and week 12|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||Percent||Standard Error|Mean
721463|NCT00309738|Secondary|Number of Patients Attaining NCEP LDL-C Target (< 160 mg/dL)|Number of patients attaining LDL-C target according to National Cholesterol Education Program (NCEP) criteria (< 160 mg/dL)|12 weeks|Full analysis set (FAS)||participants|||Number
721464|NCT00309738|Primary|Percent Change From Baseline in LDL-C|Percent change from baseline in low density lipoprotein-cholesterol (LDL-C)|12 weeks|Subjects who completed the treatment period||mg/dL||Standard Deviation|Mean
721465|NCT00309751|Secondary|Number of Patients Attaining National Cholesterol Education Program (NCEP) LDL-C Target|Number of patients attaining National Cholesterol Education Program (NCEP)LDL-C target (LDL-C less than 160 mg/dL) at 12 weeks|12 weeks|||Participants|||Number
721466|NCT00309751|Primary|Percent Change From Baseline Low Density Lipoprotein Cholesterol (LDL-C)|Percent change from baseline to Week 12 low density lipoprotein cholesterol (LDL-C)|12 weeks|||percent change||Standard Deviation|Mean
721467|NCT00309777|Secondary|National Cholesterol Education Program (NCEP) LDL-C Target Attainment|Number of subjects achieving National Cholesterol Education Program (NCEP) LDL-C Target (LDL less than or equal to 130 mg/dL)at Week 12|12 week|Full Analysis Set||Participants|||Number
721468|NCT00309777|Primary|Percent Change From Baseline in Low Density Lipoprotein-cholesterol (LDL-C) at 12 Weeks|Percent change from baseline in low density lipoprotein-cholesterol (LDL-C)after 12 Weeks|Baseline to 12 weeks|||Percent change||Standard Deviation|Mean
721469|NCT00309907|Secondary|C-reactive Protein Levels|Estimated mean and standard deviation|From baseline to days 7, 14, 21, and 28|The data for baseline were intended to be analyzed for all subjects, therefore, combined result is reported. The data for Days 7, 14, 21 and 28 were intended to be analyzed by subgroups of subjects as pre-specified in the study protocol, therefore combined result us not reported for Etanercept + corticosteroid therapy treatment arm.||mg/dL||Standard Deviation|Mean
721470|NCT00309907|Secondary|Plasma Cytokine IL6 Level|Estimated mean and standard error of IL6 level|From baseline to days 7 and 28|Plasma samples were available for biomarker analysis in 26 patients. The data were intended to be analyzed for all subjects, therefore, combined result is reported.||pg/ml||Standard Error|Mean
721471|NCT00309907|Secondary|Toxicity of Etanercept Plus Corticosteroid Therapy Using the Common Terminology Criteria Version 4.0|Grade 3-5 organ toxicities attributable to etanercept.|Up to 56 days|28 patients evaluable for this outcome.||Patients|||Number
721472|NCT00309907|Secondary|Estimate Percentage Pulmonary Response in Patients With IPS Treated With Etanercept + Corticosteroid Therapy|Pulmonary response is defined as alive & come off of oxygen .|up to day 56|Total of 28 patients are evaluable for this outcome.||percentage of participants|||Number
721916|NCT00322621|Secondary|Number of Participants Discontinuing in the Acute Phase||Baseline (Week 0) to Week 8|Participants in Acute Phase (through Week 8).||participants|||Number
721473|NCT00309907|Secondary|Survival Rate|Estimated Day 56 survival rate following initiation of etanercept + corticosteroid therapy for patients with IPS.|Up to day 56|Analysis population includes all patients who are eligible and had sufficient data to evaluate response. Eleven ineligible patients are excluded.||percentage of participants||95% Confidence Interval|Number
721474|NCT00309907|Primary|Response of IPS (Idiopathic Pneumonia Syndrome) to Etanercept Plus Corticosteroid Therapy by Day 28.|Response to therapy is defined as survival to Day 28 of study, PLUS complete discontinuation all supplemental oxygen support by Day 28 of study. Subjects must be able to remain off all supplemental oxygen support for > 72 consecutive hours. Subjects who discontinue supplemental oxygen within the last 72 hours of the observation period will be followed until they have completed 72 consecutive hours off oxygen or failed prior to assessing response.|At day 28|Analysis population includes all patients who are eligible and had sufficient data to evaluate response. Eleven ineligible patients are excluded.||participants|||Number
721475|NCT00309946|Secondary|Pharmacogenomics by Correlating Genetic Polymorphisms With Drug Activity and Toxicity|Focus on variants of genes in the pathway targeted by cediranib maleate, including kdr/flk-1 (the specific target of cediranib maleate) and the genes that encode Vascular endothelial growth factor A (VEGF-A) or HIF1α. If additional information relevant to other genes of interest in the pathway becomes available the samples will be utilized for such analysis as well.|Week 1 of course 1|This outcome was not measured/assessed for any of the study subjects.|||||
721476|NCT00309946|Secondary|Changes in Laboratory Correlates|Examined using paired t-test or Wilcoxon signed-ranks test.|Baseline, days 15 and 29 of course 1, and then every 28 days|This outcome was not measured/assessed for any of the study subjects.|||||
721477|NCT00309946|Primary|Objective Response Rate, Complete (CR) or Partial (PR) Response|Evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. To be assigned a status of PR or CR, changes in tumor measurements must be confirmed by repeat assessments that should be performed no less than 4 weeks after the criteria for response are first met.|Every 8 weeks|||percentage of participants|||Number
721478|NCT00309985|Secondary|QOL Change From Baseline to 3 Months|The primary QOL change was evaluated by the Functional Assessment of Cancer Therapy – Prostate (FACT-P) instrument. FACT-P is a self-report measure of both general and disease-specific QOL. Higher scores represent better QOL. The FACT-P (version 4) contains 39 likert items distributed over 5 subscales: physical (7 items), social/family (7 items), emotional (6 items), and functional (7 items) well-being, and the additional concerns related to prostate cancer scale (12 items). The FACT-P total score is calculated by summing all these 5 subscales and ranges from 0 to 156.|Assessed at baseline and 3 months|Patients with both baseline and 3-month QOL assessments are included in this analysis.||units on a scale||Standard Error|Mean
721479|NCT00309985|Secondary|Proportion of Patients With PSA Complete Response (CR) at 12 Months|PSA CR is defined as a PSA level less than 0.2 ng/ml measured for 2 consecutive measurements at least 4 weeks apart. Patients who met the criterion of PSA CR and had PSA level less than 0.2 ng/ml before and after the 12-month time point are considered as having a PSA CR at 12 months.|Assessed at 12 months|All randomized patients||proportion of participants||95% Confidence Interval|Number
721480|NCT00309985|Secondary|Proportion of Patients With PSA Complete Response (CR) at 6 Months|PSA CR is defined as a PSA level less than 0.2 ng/ml measured for 2 consecutive measurements at least 4 weeks apart. Patients who met the criterion of PSA CR and had PSA level less than 0.2 ng/ml before and after the 6-month time point are considered as having a PSA CR at 6 months.|Assessed at 6 months|All randomized patients||proportion of participants||95% Confidence Interval|Number
721481|NCT00309985|Secondary|Time to Castration Resistant Prostate Cancer (Hormone Refractory Disease)|Time to castration resistant prostate cancer is defined as the time from randomization to PSA progression or clinical progression, whichever occurred first. Patients without documented progression were censored at the date of last disease assessment. Secondary endpoint data reflect the database as of December 23, 2014.|Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry|All randomized patients.||months||95% Confidence Interval|Median
721482|NCT00309985|Secondary|Time to Clinical Progression|Time to clinical progression is defined as the time from randomization to clinical progression. Clinical progression is defined as increasing symptomatic bone metastases, progression per Response Evaluation Criteria In Solid Tumors (RECIST) criteria or clinical deterioration due to cancer per investigator's opinion. Patients without documented clinical progression were censored at the date of last disease assessment. Secondary endpoint data reflect the database as of December 23, 2014.|Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry|All randomized patients.||months||95% Confidence Interval|Median
721483|NCT00309985|Primary|Overall Survival|Overall survival is defined as the time from randomization to death or date last known alive. Survival data reflects the database as of December 23, 2013.|Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry|All randomized patients||months||95% Confidence Interval|Median
721484|NCT00310076|Secondary|Toxicity||24 months||||||
721485|NCT00310076|Primary|Progression Free Survival||60 months after treatment|||years||95% Confidence Interval|Median
721486|NCT00310310|Other Pre-specified|Epworth Sleepiness Scale (ESS)|ESS is a widely used subjective measure of excessive daytime sleepiness in research and clinical settings. Participants are asked to indicate how likely they would be to fall asleep in eight different situations on a scale from 0 (not likely) to 3 (highly likely). The situations are designed to vary in sleep-inducing capacity. The ESS scoring range is 0–24, with higher scores reflecting greater daytime sleepiness.|1 month|The target population for this study is all Veterans with OSA. It was expected that most participants would be middle-aged and older men and women, from a variety of ethnic backgrounds and with a full range of medical co-morbidities.||units on a scale||Standard Deviation|Mean
721487|NCT00310310|Other Pre-specified|Center for Epidemiological Studies - Depression Scale (Short Form)|"The CES-D is a 10-item self-report measure of depression. The 10-item version has adequate predictive accuracy when compared to the original full-length 20-item version, as well as adequate test-retest correlations and discriminative validity.
The total score is calculated by finding the sum of 10 items. Any score equal to or above 10 is considered depressed."|1 month|||units on a scale||Standard Deviation|Mean
721490|NCT00310310|Other Pre-specified|Quality of Well Being Scale (QWB-SA)|The QWB-SA is a generic, preference-based measure that produces a single score appropriate for cost-effectiveness estimates and has been used in veteran and other general adult populations. The advantage of having a single, scaled score instead of multiple separate subscale domains is important for comparing interventions. The QWB-SA is a comprehensive measure of health-related quality of life that consists of 78-items and five sections: (I) acute and chronic symptoms; (II) self-care activities; (III) mobility; (IV) physical activity and performance of physical functioning; and (V) social activity. The level of functioning and the subjective symptom reports are then weighted by preference, or utility, on a scale that ranges from 0 (dead) to 1.0 (optimum function).|1 month|||units on a scale||Standard Deviation|Mean
721491|NCT00310310|Other Pre-specified|Sleep Apnea Quality of Life Index (SAQLI)|"Sleep Apnea Quality of Life Index (SAQLI) which is a 35-item clinician-administered scale composed of five domains: daily functioning, social interactions, emotional functioning, symptoms, and CPAP side effects. . It has high internal consistency, strong content and construct validity, and adequate concurrent and discriminative validity, and is responsive to changes in HRQOL. The key advantages to inclusion of the SAQLI is that it is the only clinician-administered scale in the study and it contains a CPAP side effect scale that is one of the few valid measures of the frequency and amount of CPAP side effects.
A very large, All the time
A large
A moderate to large
A moderate
A small to moderate
A small
No, None, Not at all"|1 month|||units on a scale||Standard Deviation|Mean
721492|NCT00310310|Secondary|Pittsburgh Sleep Quality Index (PSQI)|"The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire aimed at assessing sleep quality and disturbances over a 1-month period.79 The PSQI measures seven areas of sleep: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Items are answered utilizing a Likert scale with 0 being indicative of better sleep and the maximum value of 3 being indicative of poor sleep. The PSQI has acceptable reliability (Cronbach’s alpha = 0.83), test-retest reliability of 0.85, and can distinguish good and poor sleepers (global PSQI score > 5 has diagnostic sensitivity = 89.6% and specificity 86.5%).
In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality."|6 Months|The target population for this study is all Veterans with OSA. It was expected that most participants would be middle-aged and older men and women, from a variety of ethnic backgrounds and with a full range of medical co-morbidities. We had a few Veterans who skipped this assessment when filling out the project assessment packet.||units on a scale||Standard Deviation|Mean
721493|NCT00310310|Secondary|Pittsburgh Sleep Quality Index (PSQI)|"The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire aimed at assessing sleep quality and disturbances over a 1-month period.79 The PSQI measures seven areas of sleep: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Items are answered utilizing a Likert scale with 0 being indicative of better sleep and the maximum value of 3 being indicative of poor sleep. The PSQI has acceptable reliability (Cronbach’s alpha = 0.83), test-retest reliability of 0.85, and can distinguish good and poor sleepers (global PSQI score > 5 has diagnostic sensitivity = 89.6% and specificity 86.5%).
In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality."|1 Month|The target population for this study is all Veterans with OSA. It was expected that most participants would be middle-aged and older men and women, from a variety of ethnic backgrounds and with a full range of medical co-morbidities.||units on a scale||Standard Deviation|Mean
721494|NCT00310310|Primary|CPAP Adherence|The investigators also examined the data obtained at the 6-month time point.|6 months|||hours per night||Standard Deviation|Mean
721495|NCT00310310|Primary|CPAP Adherence|The investigators examined the data obtained in the Sleep Apnea Self-Management Program at the one-month time point relative to participation in the Usual Care group.|1 month|||hours per night||Standard Deviation|Mean
721496|NCT00310362|Secondary|Preparation Non-adherence-flexible Sigmoidoscopy|Preparation nonadherence assessed whether patients had adequately prepared to complete the flexible sigmoidoscopy procedure.|3 months||||||
721497|NCT00310362|Secondary|Preparation Nonadherence-colonoscopy|Preparation nonadherence assessed whether patients had adequately prepared to complete the colonoscopy procedure.|3 months||||||
721498|NCT00310362|Secondary|Nonattendance-flexible Sigmoidoscopy|Nonattendance was defined as canceling the flexible sigmoidoscopy appointment or not attending the appointment|3 months||||||
721499|NCT00310362|Primary|Appointment Nonadherence-colonoscopy|Nonattendance was defined as canceling the colonoscopy appointment or not attending the appointment|3 months|||nonadherent participants|||Number
721500|NCT00310375|Secondary|Change From Baseline in Quality of Life in Epilepsy (QOLIE)-31-P Questionnaire|The QOLIE-31-P (Version 2.0) was utilized to assess quality of life. The QOLIE-31-P assessment was completed by the participants at Baseline, Month 3, Month 6, Month 9, Month 12 and annually after Month 12. The QOLIE has 7 sub scales as energy fatigue, emotional well being, social functioning, cognitive, medication effects, seizure worry and overall QOL. The assessment range for the overall score and the sub-scales is 0-100, where higher scores indicate greater well being. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles)|Assessed up to a maximum of 9 years|Safety Population||Scores on a scale||Standard Deviation|Mean
721501|NCT00310375|Secondary|Percentage of Seizure-free Days|Number of seizure free days is defined as the number of applicable days without any seizures (partial, generalized or unclassified). Only the days in which a participant had non-missing seizure data was considered as applicable days|Assessed up to a maximum of 9 years|Safety Population||Percentage of days||Standard Deviation|Mean
721502|NCT00310375|Secondary|Number of Participants Who Were Seizure Free for Any 12 Continuous Months|Duration of exposure is defined using a window range allowed for each scheduled visit. At least 12 months of exposure is defined as >= 353 days of exposure since the window range for Month 12 visit is +/- 7 days. Only those participants available at the specified time points were analyzed.|Assessed up to a maximum of 9 years|Safety Population||Participants|||Number
723428|NCT00330460|Secondary|Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|12 months|||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
721503|NCT00310375|Secondary|Number of Participants Who Were Seizure Free for Any 6 Continuous Months|Number of seizure free days is defined as the number of applicable days without any seizures (partial, generalized or unclassified). Only the days in which a subject had non-missing seizure data were considered as applicable days. Duration of exposure is defined using a window range allowed for each scheduled visit. At least 6 months of exposure is defined as >= 173 days of exposure since the window range for Month 6 visit is +/- 7 days. Only those participants available at the specified time points were analyzed.|Assessed up to a maximum of 9 years|Safety Population||Participants|||Number
721504|NCT00310375|Secondary|Number of Responders|A participant was classified as a responder if there is an at least 50% reduction from Baseline in the 28-day total Partial Seizure frequency. Baseline was defined as the parent study Baseline. Only those participants available at the specified time points were analyzed.|Assessed up to a maximum of 9 years|Safety Population||Participants|||Number
721505|NCT00310375|Secondary|Percentage Change From Baseline in the 28-day Partial Seizure|Twenty-eight-day total partial seizure frequency during the study is defined as the sum of total partial seizures from First date (Baseline visit date +1 if no seizures on Baseline or Baseline visit date if seizures reported on the Baseline) to Last date (last visit date for seizure record with non-missing response), divided by applicable days, standardized by 28 days. The applicable days are the days in which the subject had non-missing seizure data. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed.|Assessed up to a maximum of 9 years|Safety Population||Percent change||Standard Deviation|Mean
721506|NCT00310375|Primary|Number of Participants With a Decrease in Confrontational Visual Field From Initial Examination|Decrease in confrontation visual field is defined as a participant having a normal initial exam and an abnormal exam thereafter or, a response of clinically significant worsening in either eye since the last assessment.|Assessed up to a maximum of 9 years|Safety Population||Participants|||Number
721507|NCT00310375|Primary|Number of Participants With a Clinically Significant Decrease in Visual Acuity From Initial Examination|A comprehensive eye examination was conducted by retina specialist or general ophthalmologist to assess best corrected visual acuity. An initial comprehensive eye examination was completed by an ophthalmologist for all participants. This exam was not associated with a specific visit. Thereafter, eye examinations was performed approximately every 6 months. Eye examination was introduced following protocol amendment and was conducted in all participants. Participants discontinued before implementation of this amendment and who have not had a comprehensive eye examination and skin examination (and follow-up by a dermatologist, if clinically indicated) were asked to return to the clinic for an evaluation of their skin (and follow-up dermatology examination, if clinically indicated) and for a comprehensive eye examination. Number of Par. with both initial and at least one follow-up exam while on RTG treatment were analyzed.|Assessed up to a maximum of 9 years|Safety Population||Participants|||Number
721508|NCT00310375|Primary|Number of Participants With Abnormal Pigmentation of Skin, Including the Skin Around the Eyes and the Eyelids, Lips, Nails, or Mucosa|An assessment of the participant’s nails, lips, skin and mucosa was completed by the investigator at the 4 monthly study visits. The assessment of the participant’s skin included assessment of the skin around the eyes and the eyelids,lips, nails, and mucosa|Assessed up to a maximum of 9 years|Safety Population||Participants|||Number
721509|NCT00310375|Primary|Number of Participants With Pigmentation of Retinal Ocular Tissue|The ophthalmologist/retina specialist determined the presence or absence of abnormal discoloration of retinal ocular tissues. It included Pigmentary abnormalities in the macula, of peripheral retina as well as in both of them.. Only those participants available at the specified time points were analyzed.|Assessed up to a maximum of 9 years|Safety Population||Participants|||Number
721510|NCT00310375|Primary|Number of Participants With Pigmentation of Non-retinal Ocular Tissue|The ophthalmologist/retina specialist determined the presence or absence of abnormal discoloration of all non-retinal ocular tissues. Only those participants available at the specified time points were analyzed.|Assessed up to a maximum of 9 years|Safety Population||Participants|||Number
721511|NCT00310375|Primary|Number of Participants With Abnormal Results of Neurological Examination|Participants were assessed at Month 1, Month 3, Month 6, Month 9, Month 12 and every 4 months after Month 12. Participants in the worst category among the results of all neurological examination parameters are presented. Abnormal results were categorised as Abnormal not Clinically Significant (AbNCS)and Abnormal and Clinically Significant (AbCS). Only those participants available at the specified time points were analyzed (represented by n=X in the category titles)|Up to Month 108|Safety Population||Participants|||Number
721512|NCT00310375|Primary|Number of Participants With Abnormal Results in Physical Examination|A complete physical examination was performed at the end of each 12 month study cycle. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). If a participant had an abnormal result for at least one body system of exam, that participant was included in the 'Abnormal' category|Up to Month 108|Safety Population||Participants|||Number
721513|NCT00310375|Primary|Change From Baseline in Overall American Urological Association (AUA) Symptom Index Score|An AUA Symptom Index is a 7-item Likert-scored scale describing urinary bladder function and was completed by the Investigator to assess the participant’s urinary voiding function at Month 1, Month 3, Month 12 and annually after Month 12. The index scale ranges from 0-35, where higher scores are indicative of a worse issue. Scores are categorized as 0-7 mild, 8-19 moderate and >19 severe. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles)|Baseline and Up to Month 108|Safety Population||Scores on a scale||Standard Deviation|Mean
721514|NCT00310375|Primary|Change From Baseline in Post-void Residual Bladder Ultrasound Volume|Post-void residual (PVR) bladder was assessed using ultrasound scan to assess urinary retention at Month 1, Month 3, Month 12 and annually after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles)|Baseline and Up to Month 108|Safety Population||Milliliter (mL)||Standard Deviation|Mean
721515|NCT00310375|Primary|Change From Baseline in Urine Power of Hydrogen (pH)|Urine pH was assessed at Month 1, Month 3, , Month 6, Month 9, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.|Baseline and Up to Month 108|Safety Population||pH units||Standard Deviation|Mean
721516|NCT00310375|Primary|Change From Baseline in Urine Specific Gravity|Urine Specific gravity (USG) was assessed at Month 1, Month 3, , Month 6, Month 9, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.|Baseline and Up to Month 108|Safety Population||Dimensionless unit||Standard Deviation|Mean
721517|NCT00310375|Primary|Change From Baseline in Chemistry Parameter-Total Protein|Total Protein (TP) was assessed at Month 1, Month 3, , Month 6, Month 9, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles)|Baseline and Up to Month 108|Safety Population||Grams per liter (g/L)||Standard Deviation|Mean
721518|NCT00310375|Primary|Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA)|Creatinine, Total bilirubin (TB), Uric acid (UA) were assessed at Month 1, Month 3, , Month 6, Month 9, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.|Baseline and Up to Month 108|Safety Population||Micromole per Liter (umol/L)||Standard Deviation|Mean
721519|NCT00310375|Primary|Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea|Bicarbonate (Bic.), BUN, Calcium (Ca), Chloride (Cl), Cholesterol (Cho.), Non-fasting glucose (NFG), Phosphorus (P), Potassium (Ka), Sodium (Na), Urea were assessed at Month 1, Month 3, , Month 6, Month 9, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.|Baseline and Up to Month 108|Safety Population||Millimole per liter (mmol/L)||Standard Deviation|Mean
721520|NCT00310375|Primary|Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST)|Alkaline phosphatase (AP), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST) were assessed at Month 1, Month 3, , Month 6, Month 9, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.|Baseline and Up to Month 108|Safety Population||International units per litre (IU/L)||Standard Deviation|Mean
721521|NCT00310375|Primary|Change From Baseline in Haemoglobin|Haemoglobin was assessed at Month 1, Month 2, Month 3, , Month 6, Month 8, Month 9, Month 10, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available..|Baseline and Up to Month 108|Safety Population||Grams/Liter (g/L)||Standard Deviation|Mean
721522|NCT00310375|Primary|Change From Baseline in Haematocrit|Haematocrit was assessed at Month 1, Month 2, Month 3, Month 6, Month 8, Month 9, Month 10, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and Up to Month 108|Safety Population||Volume/Volume (v/v)||Standard Deviation|Mean
721523|NCT00310375|Primary|Change From Baseline in Hematology Parameter-Red Blood Cell Count|Red Blood Cell count (RBC) was assessed at Month 1, Month 2, Month 3, Month 6, Month 8, Month 9, Month 10, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available..|Baseline and Up to Month 108|Safety Population||10^12 cells/Liter(L)||Standard Deviation|Mean
721524|NCT00310375|Primary|Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC)|Following hematology parameters were assessed, Bands (Band neutrophils), Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets and WBC. Hematology parameters were assessed at Month 1, Month 2, Month 3, Month 6, Month 8, Month 9, Month 10, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.|Baseline and Up to Month 108|Safety Population||10^9 cells/Liter||Standard Deviation|Mean
721525|NCT00310375|Primary|Change From Baseline in Electrocardiogram (ECG) Parameter-QRS Axis|A 12-lead ECG was performed at each study visit during the first year of the study (Month 1, Month 3, Month 6, Month 9, Month 12) and annually after one year. ECG parameter QRS Axis is presented here. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and Up to Month 108|Safety Population||Degree||Standard Deviation|Mean
721526|NCT00310375|Primary|Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameter-RR Interval|A 12-lead ECG was performed at each study visit during the first year of the study (Month 1, Month 3, Month 6, Month 9, Month 12) and annually after one year. The following electrocardiogram parameters are presented: RR Interval. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and Up to Month 108|Safety Population||Seconds (sec)||Standard Deviation|Mean
721527|NCT00310375|Primary|Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF)|A 12-lead ECG was performed at each study visit during the first year of the study (Month 1, Month 3, Month 6, Month 9, Month 12) and annually after one year. The following electrocardiogram parameters are presented PR Interval, QRS Duration, Uncorrected QT interval (uQT), Corrected QT (Bazett's correction) interval (QTcB), Corrected QT (Friedericia's correction) interval (QTcF). Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.|Baseline and Up to Month 108|Safety Population||Milliseconds (msec)||Standard Deviation|Mean
721528|NCT00310375|Primary|Change From Baseline in Weight|Weight was measured in ordinary indoor clothing (without shoes) and was recorded at each study visit (On Month 1, Month 3, Month 6, Month 9, Month 12 and every 4 months after Month 12). Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.|Baseline and Up to Month 108|Safety Population||Kilograms||Standard Deviation|Mean
721529|NCT00310375|Primary|Change From Baseline in Body Temperature|Body temperature was measured in degree Celsius at each study visit (Month 1, Month 3, Month 6, Month 9, Month 12 and every 4 months after Month 12). Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available|Baseline and Up to Month 108|Safety Population||Degree Celsius||Standard Deviation|Mean
721530|NCT00310375|Primary|Change From Baseline in Heart Rate|Heart rate (HR) was measured in supine (Su) position and again in standing (St) position after the participant was standing for approximately 2 minutes at each study visit (Month 1, Month 3, Month 6, Month 9, Month 12 and every 4 months after Month 12). Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.|Baseline and Up to Month 108|Safety Population||Beats per Minute||Standard Deviation|Mean
721531|NCT00310375|Primary|Change From Baseline in Blood Pressure|Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was obtained in supine (Su) position and again in standing (St) position after the participant was standing for approximately 2 minutes at each study visit (Month 1, Month 3, Month 6, Month 9, Month 12 and every 4 months after Month 12). Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Not Applicable (NA) indicates that data were not available.|Baseline and Up to Month 108|Safety Population||Millimeter of mercury (mmHg)||Standard Deviation|Mean
721532|NCT00310375|Primary|Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug|The time frame of premature study discontinuation was defined as the time from the day of first the study medication to the time of withdrawal from study drug. For those who have a taper dose start date, the time of withdrawal was the day before the start of taper dose. For those without a taper dose start date, the time of withdrawal was the last dose date. Participants who switched to the commercial product were censored at the last dose of study drug in the Kaplan-Meier analysis. All participants who withdrew from study drug prematurely but didn’t switch to commercial product were counted as “events”. Kaplan-Meier estimate of the probability of discontinuation at the specified time or earlier. Number of Participants continuing on RTG at each time of withdrawal were analyzed (represented as n=X in category title).|Assessed up to a maximum of 9 years|Safety Population||Percentage Probability of d/c|||Number
721533|NCT00310375|Primary|Number of Participants With Treatment-emergent Adverse Events Leading to Withdrawal From Study Drug|Treatment-emergent AE was defined as an AE with an onset on or after the day of first dose of the study medication and on or before 30 days after the last dose date. AEs reported during parent study and worsened after first dose of RTG in this OLE study were also reported.|Assessed up to a maximum of 9 years|Safety Population||Participants.|||Number
721810|NCT00322231|Secondary|Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination|The GMT of the VZV-specific antibody responses as measured by gpELISA (glycoprotein enzyme-linked immunosorbent assay) at the prespecified day ranges at prevaccination and 4 weeks postvaccination|4 weeks postvaccination|Per-protocol population||gpELISA units/mL||95% Confidence Interval|Geometric Mean
721534|NCT00310375|Primary|Number of Participants With Treatment-emergent Serious Adverse Event (SAE) and Adverse Event (AE)|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization (unplanned hospital stay) or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect. Treatment-emergent AE was defined as an AE with an onset on or after the day of first dose of the study medication and on or before 30 days after the last dose date. AEs reported during parent study and worsened after first dose of RTG in this OLE study were also reported.|Assessed up to a maximum of 9 years|Safety Population included all participants who took at least 1 dose of study medication||Participants|||Number
721540|NCT00310427|Primary|Craving for Alcohol Evoked by Alcohol-cue Challenge|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). This is a self-report rating scale, with scores ranging from 8 (lowest craving value) to 56 (highest craving value).|Week 4|||Units on a scale||Standard Error|Mean
721541|NCT00310427|Primary|Change From Baseline in Spontaneous Alcohol Craving at Week 3, During the Second of Two Weekly Ratings.|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). This is a self-report rating scale, with scores ranging from 8 (lowest craving value) to 56 (highest craving value).|Week 3 Rating 2 minus baseline|||Units on a scale||Standard Error|Mean
721542|NCT00310427|Primary|Change From Baseline in Spontaneous Alcohol Craving at Week 3, During the First of Two Weekly Ratings.|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). This is a self-report rating scale, with scores ranging from 8 (lowest craving value) to 56 (highest craving value).|Week 3 Rating 1 minus baseline|||Units on a scale||Standard Error|Mean
721543|NCT00310427|Primary|Change From Baseline in Spontaneous Alcohol Craving at Week 2, During the Second of Two Weekly Ratings.|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). This is a self-report rating scale, with scores ranging from 8 (lowest craving value) to 56 (highest craving value).|Week 2 Rating 2 minus baseline|||Units on a scale||Standard Error|Mean
721544|NCT00310427|Primary|Change From Baseline in Spontaneous Alcohol Craving at Week 2, During the First of Two Weekly Ratings.|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). This is a self-report rating scale, with scores ranging from 8 (lowest craving value) to 56 (highest craving value).|Week 2 Rating 1 minus baseline|||Units on a scale||Standard Error|Mean
721545|NCT00310427|Primary|Change From Baseline in Spontaneous Alcohol Craving at Week 1, During the Second of Two Weekly Ratings.|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). This is a self-report rating scale, with scores ranging from 8 (lowest craving value) to 56 (highest craving value).|Week 1 Rating 2 minus baseline|||Units on a scale||Standard Error|Mean
721546|NCT00310427|Primary|Change From Baseline in Spontaneous Alcohol Craving at Week 1, During the First of Two Weekly Ratings.|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). This is a self-report rating scale, with scores ranging from 8 (lowest craving value) to 56 (highest craving value).|Week 1/Rating 1 minus baseline|||Units on a scale||Standard Error|Mean
721547|NCT00310427|Primary|Craving for Alcohol (Spontaneous)|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). This is a self-report rating scale, with scores ranging from 8 (lowest craving value) to 56 (highest craving value).|Baseline|||Units on a scale||Standard Error|Mean
721548|NCT00310440|Secondary|Kyphosis|Kyphosis is evaluated in degrees.|12 months|Per protocol (PP) subjects who had images available at 12 months were included in this analysis. Six subjects that had major protocol deviations with the potential to impact the primary endpoint results were not included in the PP population.||degrees||Standard Deviation|Mean
721549|NCT00310440|Secondary|Mean Change in the Short Form 36 v2 (SF-36v2) Mental Health Composite Score (MCS).|The SF-36 v2 (Medical Outcomes Trust, Boston, MA) is a multipurpose, patient-reported short-form health survey with 36 questions available in several languages. It yields two composite scores: one for physical health (Physical Composite Score – PCS) and one for mental health (Mental Composite Score – MCS) that are comprised of eight domains. The following domains make up the MCS: vitality, social functioning, role-emotional, mental health. The MCS ranges from a score of 0 (lowest possible level of functioning) to a score of 100 (highest possible level of functioning).|Baseline and 12 months|Per protocol (PP) subjects were included in this analysis. Six subjects that had major protocol deviations with the potential to impact the primary endpoint results were not included in the PP population.||score on a scale||95% Confidence Interval|Least Squares Mean
721550|NCT00310440|Secondary|Mean Change in the Short Form 36 v2 (SF-36v2) Physical Composite Score (PCS).|The SF-36 v2 (Medical Outcomes Trust, Boston, MA) is a multipurpose, patient-reported short-form health survey with 36 questions available in several languages. It yields two composite scores: one for physical health (Physical Composite Score – PCS) and one for mental health (Mental Composite Score – MCS) that are comprised of eight domains. The following domains make up the PCS: physical functioning, role-physical, bodily pain, general health. The PCS ranges from a score of 0 (lowest possible level of functioning) to a score of 100 (highest possible level of functioning).|Baseline and 12 months|Per protocol (PP) subjects were included in this analysis. Six subjects that had major protocol deviations with the potential to impact the primary endpoint results were not included in the PP population.||units on a scale||95% Confidence Interval|Least Squares Mean
721551|NCT00310440|Secondary|Success Rates Measured by Aggregated Modified Odom's Criteria|Subjects selected one of four categories: Excellent (Improvement Greater than or Equal to 80%, Deterioration Less than 10%), Good (Improvement Greater than or Equal to 70%, Deterioration Less than 15%), Fair (Improvement Greater than or Equal to 50%, Deterioration Less than 20%) or Poor (Improvement Less than 50%, Deterioration Greater than 20%).|12 months|Per protocol (PP) subjects that had data available at the 12 month visit were included in this analysis. Six subjects that had major protocol deviations with the potential to impact the primary endpoint results were not included in the PP population.||participants|||Number
721552|NCT00310440|Secondary|Mean Change at Pain at Arm and Shoulder Visual Analog Scale (VAS).|"The pain VAS is a continuous scale upon which the subject indicates their pain level ranging from No pain at all (0) to Worst imaginable pain (10). The change in pain is calculated by subtracting the 12 month score from the baseline score."|Baseline and 12 months|Per protocol (PP) subjects were included in this analysis. Six subjects that had major protocol deviations with the potential to impact the primary endpoint results were not included in the PP population.||cm||95% Confidence Interval|Mean
721553|NCT00310440|Secondary|Mean Change in Pain at Neck Visual Analog Scale (VAS).|"The pain VAS is a continuous scale upon which the subject indicates their pain level ranging from No pain at all (0) to Worst imaginable pain (10). The change in pain is calculated by subtracting the 12 month score from the baseline score."|Baseline and 12 months|Per protocol (PP) subjects were included in this analysis. Six subjects that had major protocol deviations with the potential to impact the primary endpoint results were not included in the PP population.||cm||95% Confidence Interval|Mean
721554|NCT00310440|Primary|Complications|Any AE within 12 months of surgery.|12 months|All enrolled subjects.||participants|||Number
721555|NCT00310440|Primary|Neurologic Success|The neurological endpoint is a binary variable. Neurologic success was assessed in the motor, sensory and reflex domains specific for the cervical spine as follows: maintenance or improvement of motor function in the elbow flexors (i.e. biceps muscle), elbow extensors (i.e. triceps muscle) and wrist extensors of both arms; maintenance or improvement of sensory function of both arms; maintenance or improvement of reflexes of both arms as measured at biceps tendon, triceps tendon and brachioradialis (supinator) reflex AND absence of Babinski reflex (if not present prior to surgery). Worsening of neurological status (neurological failure) was defined as a permanent decline in the subject's neurological status based on adjudication of accumulated neurological data by an independent blinded evaluator.|12 months|The total number of observed subjects.||participants|||Number
721556|NCT00310440|Primary|Change in of the Overall Neck Disability Index (NDI) Score From Baseline.|The NDI consists of ten items addressing functional activities (personal care, lifting, reading, work, driving, sleeping, recreational activities), pain intensity, concentration and headache. For each item, there are six potential responses, describing increasing degrees of disability (no disability = 0 to total disability = 5). An overall NDI score, out of 100, is calculated by adding up the scores for each item and multiplying by two. A higher NDI score indicates greater disability.|12 months|Per protocol (PP) subjects were included in this analysis. Six subjects that had major protocol deviations with the potential to impact the primary endpoint results were not included in the PP population.||units on a scale||95% Confidence Interval|Least Squares Mean
721557|NCT00310440|Primary|Radiologic Fusion|Successful fusion was based on roentgenographic examination showing: evidence of bridging trabecular bone between the involved motion segments, translational motion <3mm, and angular motion <5 degrees. If there was a lack of evidence of fusion on 12 month plain x-ray examination, a CT-scan was performed and final determination of the fusion status was made using the CT reading. The criteria for fusion on CT scans were: trabecular bone formation patterns within the intervertebral disc space and bridging bone formation that crosses the interspace.|12 months|All participants that have radiological data at 12 months including imputed data.||participants|||Number
721558|NCT00310466|Primary|Daily Rhinoconjunctivitis Rescue Medication Score|Rescue medication (desloratadine tablets, budesonide nasal spray, prednisone tablets) used for treatment of rhinoconjunctivitis symptoms not controlled by the study medication, were recorded. The total daily score was 0-30 (No medication-Maximum use of medication).|Birch pollen season 2006|||Units on a scale (0-30)||Standard Deviation|Mean
721559|NCT00310466|Secondary|Adverse Events|An adverse event was defined as: Any untoward medical occurence in a patient or clinical trial subject administered a trial product and which does not necessarily have a causal relationship with this treatment (International Conference of Harmonisation (ICH) Harmonised Tripartite Guideline E2A, Step 5).|Birch pollen season 2006|||Events|||Number
721560|NCT00310466|Secondary|Global Improvement of Rhinoconjunctivitis Symptoms Assessed by the Subjects|The number of participants who reported improved overall symptoms compared to the previous birch pollen season (each patient was asked to compare his/her symptoms in the 2006 birch pollen season with the symptoms in the 2005 birch pollen season).|Birch pollen season 2006|||Participants|||Number
721561|NCT00310466|Primary|Daily Rhinoconjunctivitis Symptom Score|A total of 6 rhinoconjunctivitis symptoms are recorded (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes, watery eyes). Each symptoms is scored on a scale from 0-3 (no symptoms-severe symptoms). I.e. the total daily score can be 0-18.|Birch pollen season 2006|||Units on a scale (0-18)||Standard Deviation|Mean
721562|NCT00310791|Primary|Areal Bone Density by DXA||18-Months|||g/cm2||Standard Deviation|Mean
721563|NCT00310804|Secondary|Safety Data of Subjects Upto Six Months After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine|Additional safety data from day 1 through day 181 after one dose of cTIV (combined) or TIV in terms of serious adverse events (SAEs), adverse events (AEs) necessitating a physician's visit and/or resulting in premature subject's withdrawal from study is reported.|Day 1 - Day 181 postvaccination|This analysis was done on safety dataset.||subjects|||Number
721564|NCT00310804|Secondary|Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine.|"To assess the safety and tolerability in terms of number of subjects reporting solicited adverse events following one injection of
one dose of cTIV for each of the three vaccine lots separately and
for one dose of cTIV (combined) compared to TIV."|Day 1 to Day 7 postvaccination|Analysis was done on safety dataset.||subjects|||Number
721565|NCT00310804|Primary|Percentage of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Either Cell-derived or Egg-derived Subunit Trivalent Influenza Vaccine|"Immunogenicity was assessed in terms of percentage of adult subjects showing seroconversion or significant increase in HI antibody titers after
one dose of cTIV for each of the three vaccine lots separately and
one dose of cTIV (combined) compared to TIV, according to the CHMP criterion.
European Licensure (CHMP) criterion is met if the percentage of subjects achieving seroconversion or significant increase is >40%.
As per European Licensure (CHMP) criterion seroconversion is defined as percentage of subjects with a prevaccination HI titer <10 to a postvaccination titer ≥40; whereas, significant increase is defined as HI titer ≥10 prevaccination and ≥4-fold Hi titer increase post-vaccination."|Day 22 postvaccination|This analysis was done on PP population.||Percentages||95% Confidence Interval|Number
721566|NCT00310804|Primary|Percentage of Subjects With HI Titers ≥40|"Immunogenicity was assessed in terms of percentage of adult subjects achieving HI titers ≥40, after
one dose of cTIV for each of the three vaccine lots separately and
for one dose of cTIV (combined) compared to TIV, according to the CHMP criterion.
European Licensure (CHMP) criterion is met if the percentage of subjects achieving HI titers ≥40 is >70%."|Day 22 postvaccination|This analysis was done on PP population.||Percentages||95% Confidence Interval|Number
721567|NCT00310804|Primary|Geometric Mean Ratios After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects|"Immunogenicity was assessed in terms of Geometric Mean Ratio (GMR) following
one dose of cTIV for each of the three vaccine lots separately and
for one dose of cTIV (combined) compared to TIV, according to the CHMP criterion.
The European licensure (CHMP) criterion is met if the mean geometric increase (GMR, day 22/day 1) in HI antibody titer is >2.5."|Day 22 postvaccination|The analysis was performed as PP dataset.||Ratio||95% Confidence Interval|Geometric Mean
721568|NCT00310804|Primary|Geometric Mean Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects|"The haemagglutinin Inhibition (HI) antibody titer response following
one dose of cTIV for each of the three lots separately and
one dose of cTIV (combined) compared to TIV is reported as Geometric mean titers (GMTs).
The HI GMTs were evaluated using egg-derived antigen assay."|Day 22 postvaccination|This analysis was done on per protocol (PP) population defined as all subjects who received all the relevant doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol deviation.||Titers||95% Confidence Interval|Geometric Mean
721569|NCT00310817|Secondary|Numbers of Subjects 12 to 59 Months Of Age Who Reported Unsolicited Adverse Events and Serious Adverse Events After Any Vaccination|Safety was assessed as the number of subjects 12 to 59 months of age who reported serious adverse events (SAE), AEs necessitating a physician’s visit and/or resulting in premature withdrawal from the study, AEs were to be collected between day 7 and the subsequent visit (approximately 1 month later) after the first or second vaccination(s) of MenACWY-CRM vaccine, with or without adjuvant, or MenACWY-PS vaccine. Any SAE were to be collected throughout the study.|28 days after first vaccination and 21 days after second vaccination|Analysis was done on Safety dataset - all subjects who received at least one dose of vaccine and with some post-baseline safety data.||Subjects|||Number
721570|NCT00310817|Secondary|Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination|Safety was assessed as the number of subjects 12 to 59 months of age who reported solicited local and systemic adverse events from day 1 up to and including day 7 after the first or second vaccination(s) with MenACWY-CRM vaccine, with adjuvant or without adjuvant or MenACWY-PS vaccine.|From day 1 through day 7 after first or second vaccination(s)|Analysis was done on Safety dataset - all subjects who received at least one dose of vaccine and with some post-baseline safety data.||Subjects|||Number
721571|NCT00310817|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:8 After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age|Persistence of immune response, at 12 months following administration of two doses of MenACWY-CRM vaccine, with adjuvant or without adjuvant, in subjects aged 12 to 35 months of age, as measured by the percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.|12 months after second vaccination|Analysis was done on per protocol dataset - subjects in the Modified Intention to treat population who received the two doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol deviation.||percentages of subjects||95% Confidence Interval|Number
721572|NCT00310817|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:4 After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age|Persistence of immune response, at 12 months following administration of two doses of MenACWY-CRM vaccine, with adjuvant or without adjuvant, in subjects aged 12 to 35 months of age, as measured by the percentage of subjects with hSBA titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.|12 months after second vaccination|Analysis was done on per protocol dataset - subjects in the Modified Intention to treat population who received the two doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol deviation.||percentages of subjects||95% Confidence Interval|Number
721573|NCT00310817|Secondary|hSBA GMTs After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age|Persistence of immune response at 12 months following administration of two doses of MenACWY-CRM vaccine, with adjuvant or without adjuvant, in subjects aged 12 to 35 months, as measured by hSBA GMTs against N. meningitidis serogroups A, C, W, and Y.|12 months after second vaccination|Analysis was done on PP dataset Immunogenicity of a booster dose - subset of subjects in the MITT population who received a booster dose of either MenACWY Ad+/Ad- conjugate vaccine, and provided evaluable serum samples at day 169, 358 & had no major protocol deviation.||titers||95% Confidence Interval|Geometric Mean
721574|NCT00310817|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM Vaccine, With or Without Adjuvant, In Subjects 12-35 Months Of Age|Booster effect of a second dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, administered either at 6 or 12 months after an initial dose in children aged 12 to 35 months, as measured 21 days after the booster dose by the percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.|21 days after second vaccination|Analysis was done on per protocol dataset - subjects in the Modified Intention to treat population who received the two doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol deviation.||percentages of subjects||95% Confidence Interval|Number
721575|NCT00310817|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age|Booster effect of a second dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, administered at 6 or 12 months after an initial dose in children aged 12 to 35 months, as measured 21 days after the booster dose by the percentage of subjects with hSBA titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.|21 days after second vaccination|Analysis was done on per protocol dataset - subjects in the Modified Intention to treat population who received the two doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol deviation.||percentages of subjects||95% Confidence Interval|Number
723429|NCT00330460|Secondary|Trochanter Bone Mineral Density Percent Change From Baseline at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|12 months|||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
721576|NCT00310817|Secondary|hSBA GMT After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age|Booster effect of a second dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, administered at 6 or 12 months after an initial dose in children aged 12 to 35 months, as measured 21 days after the booster dose by hSBA GMTs against N. meningitidis serogroups A, C, W, and Y.|21 days after the second vaccination|||titers||95% Confidence Interval|Geometric Mean
721577|NCT00310817|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of MenACWY-CRM Vaccine, With or Without Adjuvant, In Subjects 12-35 Months Of Age|Persistence of immune response at 6 or 12 months after one dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, in subjects aged 12 to 35 months of age, as measured by the percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.|6 months after first vaccination and 12 months after first vaccination|Analysis was done on per protocol dataset - subjects in the Modified Intention to treat population who received the two doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol deviation.||percentages of subjects||95% Confidence Interval|Number
721578|NCT00310817|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:4 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age|Persistence of immune response at 6 or 12 months following administration of one dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, in subjects aged 12 to 35 months, as measured by the percentage of subjects with hSBA titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.|6 months after first vaccination and 12 months after first vaccination|Analysis was done on PP dataset -subset of subjects in the MITT population for the evaluation of immunogenicity after the 1st dose of either MenACWY Ad+ / Ad- conjugate vaccine who received a booster dose of either Novartis MenACWY Ad+/ Ad- conjugate vaccine, provided evaluable serum samples at day 169 and 358, had no major protocol deviation.||percentages of subjects||95% Confidence Interval|Number
721579|NCT00310817|Secondary|hSBA GMTs After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age|Persistence of immune response at 6 or 12 months following administration of one dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, in subjects aged 12 to 35 months, as measured by hSBA GMTs against N. meningitidis serogroups A, C, W, and Y.|6 months after first vaccination and 12 months after first vaccination|Analysis was done on per protocol dataset - subjects in the Modified Intention to treat population who received the two doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol deviation.||titers||95% Confidence Interval|Geometric Mean
721580|NCT00310817|Secondary|hSBA GMTs After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age|Immune response to a second dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, administered 28 days after the initial dose to subjects aged 12 to 35 months, as measured 21 days after the second dose by hSBA GMTs against N. meningitidis serogroups A, C, W, and Y.|21 days after second vaccination|Analysis was done on per protocol dataset - subjects in the Modified Intention to treat population who received the two doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol deviation.||titers||95% Confidence Interval|Geometric Mean
721581|NCT00310817|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age|Immune response to a second dose of either MenACWY-CRM vaccine, with adjuvant or without adjuvant, administered 28 days after the initial dose to subjects aged 12 to 35 months, as measured 21 days after the second dose by the percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.|21 days after second vaccination|Analysis was done on per protocol dataset - subjects in the Modified Intention to treat population who received the two doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol deviation.||percentages of subjects||95% Confidence Interval|Number
721582|NCT00310817|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age|Immune response to a second dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, administered 28 days after initial dose to subjects aged 12 to 35 months, as measured 21 days after the second dose by the percentage of subjects with hSBA titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.|21 days after second vaccination|Analysis was done on per protocol (PP) dataset, Immunogenicity after one dose of vaccine -subjects in the modified intention to treat population who received two doses of the study vaccine, provided an evaluable serum sample at baseline and 28 days after the second dose and had no major protocol deviation.||percentages of subjects||95% Confidence Interval|Number
721583|NCT00310817|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age|Immune response of one dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, 28 days after administration to subjects aged 12 to 35 months, as measured by the percentage of subjects with human complement serum bactericidal antibody (hSBA) titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.|28 days after first vaccination.|Analysis was done on per protocol (PP) dataset -subjects in the modified intention to treat population who received one dose of the study vaccine, and provided an evaluable serum sample at baseline and 28 days after the vaccine dose and had no major protocol deviation.||percentages of subjects||95% Confidence Interval|Number
721584|NCT00310817|Secondary|hSBA GMT After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age|Immune response of one dose of MenACWY-CRM vaccine with adjuvant or without adjuvant, 28 days after administration to subjects aged 12 to 35 months, as measured by hSBA GMTs against N. meningitidis serogroups A, C, W, and Y.|28 days after first vaccination|Analysis was done on per protocol (PP) dataset -subjects in the modified intention to treat population who received one dose of the study vaccine, and provided an evaluable serum sample at baseline and 28 days after the vaccine dose and had no major protocol deviation.||titers||95% Confidence Interval|Geometric Mean
721666|NCT00321763|Primary|Number of Subjects With Medically Significant Conditions (MSCs).|MSCs were defined as conditions prompting emergency room visits or physician visits that were not related to common diseases or routine visits. This table includes rare events, defined as events with an occurrence rate of 0.1 % and belonging to the MSCs.|From Day 0 to Day 180|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||subjects|||Number
721585|NCT00310817|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:4 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age|Immune response of one dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, 28 days after administration to subjects aged 12 to 35 months, as measured by the percentage of subjects with hSBA titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.|28 days after first vaccination.|Analysis was done on per protocol (PP) dataset - subjects in the modified intention to treat population who received one dose of the study vaccine, and provided an evaluable serum sample at baseline and 28 days after the vaccine dose and had no major protocol deviation.||percentages of subjects||95% Confidence Interval|Number
721586|NCT00310817|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age|Booster effect of a second dose of MenACWY-CRM(Ad-) vaccine administered either 6 or 12 months after an initial dose of MenACWY-CRM(Ad-) or MenACWY-PS in children aged 36 to 59 months, as measured 21 days after the booster dose by the percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.|21 days after the second vaccination|Analysis was done on per protocol (PP) dataset - subjects in the modified intention to treat population who received two doses of the study vaccine, provided an evaluable serum sample at baseline and 28 days after the second dose and had no major protocol deviation.||percentages of subjects||95% Confidence Interval|Number
721587|NCT00310817|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age|Booster effect of a second dose of MenACWY–CRM(-Ad) vaccine administered either 6 or 12 months after an initial dose of MenACWY-CRM(Ad-) or MenACWY-PS in children aged 36 to 59 months, as measured 21 days after the booster dose by the percentage of subjects with hSBA titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.|21 days after second vaccination|Analysis was done on PP dataset- subjects who received a dose of either MenACWY-CRM(Ad+) or MenACWY-CRM(Ad-)vaccine or MenACWY-PS vaccine at either 6 or 12 months from the first vaccination, and provided evaluable serum samples at baseline, at 28 days and 50 days after the first vaccine dose and had no major protocol deviation.||percentages of subjects||95% Confidence Interval|Number
721588|NCT00310817|Secondary|hSBA GMTs After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age|Booster effect of a second dose of MenACWY-CRM(Ad-) vaccine administered either 6 or 12 months after an initial dose of MenACWY-CRM(Ad-) or MenACWY-PS vaccine in children aged 36 to 59 months, as measured 21 days after the booster dose by hSBA GMT against N. meningitidis serogroups A, C, W, and Y.|21 days after second vaccination|Analysis was done on per protocol (PP) dataset, Immunogenicity after one dose of vaccine -subjects in the modified intention to treat population who received two doses of the study vaccine, provided an evaluable serum sample at baseline and 28 days after the second dose and had no major protocol deviation.||titers||95% Confidence Interval|Geometric Mean
721589|NCT00310817|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of Either MenACWY -CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age|Persistence of functional immune response at 6 or 12 months following administration of one dose of either MenACWY-CRM(Ad-) or MenACWY-PS vaccine in children aged 36 to 59 months, as measured by the percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.|6 months after first vaccination and 12 months after first vaccination|Analysis was done on PP dataset -subjects in the MITT who received a dose of either MenACWY-CRM(Ad+) or MenACWY-CRM(Ad-) or MenACWY-PS vaccine at either 6 or 12 months from the 1st vaccination, and provided evaluable serum samples at baseline, at 28 days and 50 days after the 1st vaccine dose and had no major protocol deviation.||percentages of subjects||95% Confidence Interval|Number
721590|NCT00310817|Secondary|Percentage of Subjects With hSBA Titers ≥ 1:4 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age|Persistence of functional immune response at 6 or 12 months following administration of one dose of either MenACWY-CRM(Ad-) or MenACWY-PS vaccine in children aged 36 to 59 months, as measured by the percentage of hSBA titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.|6 months after first vaccination and 12 months after first vaccination|Analysis was done on PP dataset- subjects who received a dose of either MenACWY-CRM(Ad+) or MenACWY(Ad-) vaccine or MenACWY-PS vaccine at either 6 or 12 months from the first vaccination, and provided evaluable serum samples at baseline, at 28 days and 50 days after the first vaccine dose and had no major protocol deviation.||percentages of subjects||95% Confidence Interval|Number
721591|NCT00310817|Secondary|hSBA GMTs After One Dose of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age|Persistence of functional immune response at 6 or 12 months following administration of one dose of either MenACWY-CRM(Ad-) or MenACWY-PS vaccine in children aged 36 to 59 months, as measured by hSBA GMTs against N. meningitidis serogroups A, C, W, and Y.|6 months after first vaccination and 12 months after first vaccination|Analysis was done on PP dataset -subset of subjects in the MITT population for the evaluation of immunogenicity after the 1st dose of either MenACWY Ad+/PS vaccine, provided evaluable serum samples at day 169 day 358 and had no major protocol deviation.||titers||95% Confidence Interval|Geometric Mean
721592|NCT00310817|Secondary|hSBA Geometric Mean Titers (GMT) After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age|Immune response of one dose of MenACWY-CRM(Ad-) vaccine compared with that of one dose of MenACWY-PS vaccine, 28 days after administration in subjects 36-59 months of age, as measured by hSBA geometric mean titers (GMTs) against N. meningitidis serogroups A, C, W, and Y.|28 days after first vaccination|Analysis was done on per protocol (PP) dataset -subjects in the modified intention to treat population who received one dose of the study vaccine, and provided an evaluable serum sample at baseline and 28 days after the vaccine dose and had no major protocol deviation.||titers||95% Confidence Interval|Geometric Mean
721593|NCT00310817|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age|Immune response of one dose of MenACWY-CRM(Ad-) compared to that of a MenACWY-PS vaccine, 28 days after administration to subjects aged 36 to 59 months, as measured by the percentages of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.|28 days after first vaccination|Analysis was done on per protocol (PP) dataset, Immunogenicity after one dose of vaccine -subjects in the modified intention to treat population who received one dose of the study vaccine, and provided an evaluable serum sample at baseline and 28 days after the vaccine dose and had no major protocol deviation.||percentages of subjects||95% Confidence Interval|Number
721594|NCT00310817|Primary|Percentages of Subjects With Human Complement Serum Bactericidal Activity (hSBA) Titers ≥ 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age|Immune response of one dose of MenACWY-CRM(Ad-) compared to that of one dose of MenACWY polysaccharide(MenACWY-PS) vaccine, 28 days after administration to subjects aged 36 to 59 months, as measured by the percentage of subjects with human complement serum bactericidal activity (hSBA) titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.|28 days after first vaccination.|Analysis was done on per protocol (PP) dataset -subjects in the modified intention to treat population who received one dose of the study vaccine, and provided an evaluable serum sample at baseline and 28 days after the vaccine dose and had no major protocol deviation.||percentages of subjects||95% Confidence Interval|Number
721595|NCT00310856|Secondary|Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination|The safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 through day 7 following any vaccination of MenACWY-CRM, MenC-CRM and concomitant vaccination|From day 1 through day 7 after any vaccination|Analysis was done on the safety population, i.e. all subjects who had at least one vaccination and some postbaseline safety data.||Number of subjects|||Number
721596|NCT00310856|Secondary|hSBA GMT Against Meningococcal Serogroup C After MenACWY-CRM Vaccination Administered at 18 Months of Age, Following One Vaccination of MenC-CRM at 12 Months of Age|Booster response was measured as the hSBA GMT against meningococcal serogroup C, before and 1 month after MenACWY-CRM vaccination administered at 18 months of age, following one vaccination of MenC-CRM at 12 months of age|Before and 1 month after MenACWY-CRM vaccination at 18 months|Analysis was done on PP population.||Geometric mean titers||95% Confidence Interval|Geometric Mean
721597|NCT00310856|Secondary|Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup C After MenACWY-CRM Vaccination Administered at 18 Months of Age, Following One Vaccination of MenC-CRM at 12 Months of Age|Booster response was measured as the percentage of subjects who achieved hSBA titers ≥1:4 or ≥1:8 against meningococcal serogroup C, before and 1 month after MenACWY-CRM vaccination administered at 18 months of age, following one vaccination of MenC-CRM at 12 months of age|Before and 1 month after MenACWY-CRM vaccination at 18 months|Analysis was done on PP population.||Percentage of subjects||95% Confidence Interval|Number
721598|NCT00310856|Secondary|hSBA GMTs Against Meningococcal Serogroups A, W and Y After One Vaccination of MenACWY-CRM Administered at 18 Months of Age|The immune response was measured as the hSBA GMTs against meningococcal serogroups A, W and Y, before and 1 month after one vaccination of MenACWY-CRM administered concomitantly with Pentacel at 18 months of age|Before and 1 month after MenACWY-CRM vaccination at 18 months|Analysis was done on PP population.||Geometric mean titers||95% Confidence Interval|Geometric Mean
721599|NCT00310856|Secondary|Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup A, W and Y After One Vaccination of MenACWY-CRM Administered at 18 Months of Age|Immunogenicity was measured as the percentage of subjects who achieved hSBA titers ≥1:4 or ≥1:8 against meningococcal serogroups A, W and Y, before and 1 month after one vaccination of MenACWY-CRM administered concomitantly with Pentacel at 18 months of age|Before and 1 month after MenACWY-CRM vaccination at 18 months|Analysis was done on PP population.||Percentage of subjects||95% Confidence Interval|Number
721600|NCT00310856|Secondary|Geometric Mean hSBA Titers Against Meningococcal Serogroup C After One Vaccination of MenC-CRM Administered at 12 Months of Age|The immune response was measured as the hSBA GMT against meningococcal serogroup C, before and 1 month after one vaccination of MenC-CRM administered concomitantly with Prevnar at 12 months of age|Before and 1 month after MenC-CRM vaccination at 12 months|Analysis was done on PP population.||Geometric mean titers||95% Confidence Interval|Geometric Mean
721601|NCT00310856|Secondary|Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup C After One Vaccination of MenC-CRM Administered at 12 Months of Age|Immunogenicity was measured as the percentage of subjects who achieved hSBA titers ≥1:4 or ≥1:8 against meningococcal serogroup C, before and 1 month after one vaccination of MenC-CRM administered concomitantly with Prevnar at 12 months of age|Before and 1 month after MenC-CRM vaccination at 12 months|Analysis was done on PP population.||Percentage of subjects||95% Confidence Interval|Number
721602|NCT00310856|Secondary|Percentage of Subjects With hSBA Titers ≥1:8 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule|Immunogenicity was measured as the percentage of subjects with hSBA titers ≥1:8 against meningococcal serogroups A, C, W and Y, before vaccination and 1 month after 2-dose schedule of MenACWY-CRM administered at 6 and 12 months of age (MenACWY-CRM_6-12 M group) or 1-dose schedule administered at 12 months of age (MenACWY-CRM_12 M)|Before and 1 month after 2-dose or 1-dose schedule|Analysis was done on PP population.||Percentage of subjects||95% Confidence Interval|Number
721603|NCT00310856|Secondary|Geometric Mean hSBA Titers Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule|The immune response was measured as the hSBA geometric mean titers (GMTs) against meningococcal serogroups A, C, W and Y, before vaccination and 1 month after 2-dose schedule of MenACWY-CRM administered at 6 and 12 months of age (MenACWY-CRM_6-12 M group) or 1-dose schedule administered at 12 months of age (MenACWY-CRM_12 M group)|Before and 1 month after 2-dose or 1-dose schedule|Analysis was done on PP population.||Geometric mean titers||95% Confidence Interval|Geometric Mean
721604|NCT00310856|Primary|Percentage of Subjects With hSBA Titers ≥1:4 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule|Immunogenicity was measured as the percentage of subjects with hSBA titers ≥1:4 against meningococcal serogroups A, C, W and Y, evaluated by serum bactericidal assay using human complement (hSBA), before vaccination and 1 month after 2-dose schedule of MenACWY-CRM administered at 6 and 12 months of age (MenACWY-CRM_6-12 M group) or 1-dose schedule administered at 12 months (MenACWY-CRM_12 M group)|Before and 1 month after 2-dose or 1-dose schedule|Analysis was done on per protocol (PP) population, i.e subjects in the exposed population who received all the relevant doses of vaccines correctly; and provided evaluable serum samples at the relevant time points; and had no major protocol violation as defined prior to unblinding.||Percentage of subjects||95% Confidence Interval|Number
722028|NCT00323492|Secondary|Change From Baseline to Week 12 in Fasting High-density Lipoprotein Cholesterol (HDL-CHO)|Centralized laboratory assessment. Change = Week 12 value minus baseline value.|Baseline to Week 12|ITT. Missing values were excluded.||mmol/L||Inter-Quartile Range|Median
721605|NCT00319436|Secondary|Maternal Substance Abuse (Assessed With Urine Toxicology Screens)|Maternal substance use was monitored weekly using results from weekly urine toxicology (UTOX) screens testing for presence of opiate, cocaine, and cannabis metabolites in urine samples collected at the outpatient clinic. For each month of the mother’s participation in the study, a mother received a score of “0” if no drug metabolites were present in any of her urine toxicology screens during that month or a score of “1” if one or more of her urine toxicology screens tested positive for a drug metabolite during that month. A percentage was calculated by= number of positive substance tests/number of total test *100 for each patients during each month.|post-treatment and 6-wk follow up|Data analysis was conducted for ITT sample. Baseline data was available for 47 mothers. Missing post-tx and follow up scores for mothers who left treatment early were estimated as equal to baseline scores. Post-tx and follow up scores for mothers who completed treatment but not post-tx or follow up visits were estimated as equal to tx group means.||% positive utox screens/month||Standard Error|Mean
721606|NCT00319436|Secondary|Maternal Psychiatric Distress (Assessed With the Brief Symptom Inventory)|The Brief Symptom Inventory (BSI; Derogatis, 1993) was used to assess maternal global psychiatric distress. The BSI is a standardized, widely used, 53-item, 5-point, self-report measure of psychopathology. The composite Global Severity Index (GSI) measures current overall symptomatology across multiple domains and has demonstrated good reliability and validityT-scores have a mean of 50 and a standard deviation of 10. Scores within one standard deviation (ie. a T-score of 10) above the mean on any dimension are regarded as being within the normal range on that dimension (Derogatis, 1993). These scores were converted to T-scores using data from the scoring manual. The higher the scores are worse.T scores above 60 on the GSI indicate risk for a clinical disorder.|post-treatment and 6-wk follow up|Data analysis was conducted for ITT sample. Baseline data was available for 47 mothers. Missing post-tx and follow up scores for mothers who left treatment early were estimated as equal to baseline scores. Post-tx and follow up scores for mothers who completed treatment but not post-tx or follow up visits were estimated as equal to tx group means.||units on a scale||Standard Deviation|Mean
721607|NCT00319436|Secondary|Maternal Depression (Measured With the Beck Depression Inventory)|The Beck Depression Inventory (BDI; Beck, Steer, & Brown, 1996) was used to assess maternal symptoms of depression. The BDI is a widely used 21-item questionnaire rated on a 4-point scale and yields a total score ranging from 0 to 63: scores between 13 and 19 indicate mild depression; scores between 20 and 28 indicate moderate levels of depression, and scores between 29 and 63 indicate severe levels of depression (Beck et al., 1996).|post-treatment and 6-wk follow up|Data analysis was conducted for ITT sample. Baseline data was available for 47 mothers. Missing post-tx and follow up scores for mothers who left treatment early were estimated as equal to baseline scores. Post-tx and follow up scores for mothers who completed treatment but not post-tx or follow up visits were estimated as equal to tx group means.||units on a scale||Standard Deviation|Mean
721608|NCT00319436|Secondary|Child Behavior (Assessed With the NCAST Teaching Scales)|Child behavior with the mother was assessed using the Clarity of Cues and the Responsiveness to Caregiver Subscales from the NCAST Teaching Scales. The Child Total Score is the sum of the 2 scales (23 items) with scores ranging from 0 to 23. The Child Contingency Score is the sum of 12 contingent items from the 2 scales (with scores ranging from 0 - 12). The 2 subscores are summed to arrive at the composite score. Higher scores are better. The normative means for the children of high school educated mothers reported in the scoring manual: Total Child Score = 15.44 (4.29), Clarity of Cues = 7.99 (1.49), Responsiveness to Parent = 7.45 (3.16).|post-treatment and 6-wk follow up|Data analysis was conducted for ITT sample. Baseline data was available for 47 mothers. Missing post-tx and follow up scores for mothers who left treatment early were estimated as equal to baseline scores. Post-tx and follow up scores for mothers who completed treatment but not post-tx or follow up visits were estimated as equal to tx group means.||units on a scale||Standard Deviation|Mean
721609|NCT00319436|Secondary|Maternal Caregiving Behavior (Assessed With the NCAST Teaching Scales)|Mothers choose a task to teach the child in a 5 minute teaching session. Maternal behavior is coded on 4 dimensions: Sensitivity to Cues, Response to Distress, Social-Emotional Growth Fostering, & Cognitive Growth Fostering. The Total Caregiver Score is the sum of the 4 subscale scores (73 items) with scores ranging from 0 to 73. The Total Caregiver Contingency Score is the sum of 20 items from the 4 subscales that involve the caregiver’s contingent response to child cues (scores range from 0 to 20). Higher score are better and lower scores are worse. For mothers with high school education (which a majority in our sample had) here are the normative means (SDs) reported in the scoring manual: Total Caregiver Score = 40.69 (6.85), Sensitivity to Cues = 9.16 (1.62), Response to Distress = 10.04 (1.78), Social-Emotional Growth = 8.99 (1.83), Cognitive Growth = 12.51 (3).|post-treatment, 6-week follow up|Data analysis was conducted for ITT sample. Baseline data was available for 47 mothers. Missing post-tx and follow up scores for mothers who left treatment early were estimated as equal to baseline scores. Post-tx and follow up scores for mothers who completed treatment but not post-tx or follow up visits were estimated as equal to tx group means.||units on a scale||Standard Deviation|Mean
721610|NCT00319436|Primary|Quality of Maternal Representations of the Child (Assessed With the Working Model of the Child Interview)|The Working Model of the Child Interview (WMCI; Zeanah & Benoit, 1993) is a 1.5 hour interview used to elicit a narrative description of the mother’s perceptions of her child and their relationship. The rater was trained to reliably code 6 qualitative subscales: Openness, Richness, Coherence, Caregiving Sensitivity and Acceptance and Involvement. On the mean of six subscales, a score of three is considered to represent average representational quality, scores of 1 and 2 are considered to represent clinical risk and scores of 4 and 5 are considered to represent optimal quality.|post-treatment, 6-week follow up|Data analysis was conducted for ITT sample. Baseline data was available for 47 mothers. Missing post-tx and follow up scores for mothers who left treatment early were estimated as equal to baseline scores. Post-tx and follow up scores for mothers who completed treatment but not post-tx or follow up visits were estimated as equal to tx group means.||units on a scale||Standard Deviation|Mean
721651|NCT00321698|Secondary|Prostate-specific Antigen Short-term Response Rate Measured as a Percentage Change in PSA|"All participants were combined for this assessment as pre-specified in the protocol.
The percentage change for patients were determined from pre- and post- treatment PSA values. The mean percentage change in PSA will be reported.
PSA will be monitored every 3-6 months during the first 5 years, then annually after surgery for up to 10 years"|Baseline (pre-treatment) and 1 month after surgery (post-treatment)|Pre- and post-treatment PSA values were available in 22 of 25 patients.||percentage change||95% Confidence Interval|Mean
721611|NCT00319436|Primary|Maternal Capacity for Reflective Functioning (Assessed With the Parent Development Interview)|The Parent Development Interview (PDI) was used to measure maternal capacity to mentalize about her own and her child’s behavior. The PDI is a 1 hour semi-structured interview designed to elicit the mother’s narrative about commonly occurring, emotionally-challenging aspects of parenting. A rating of 1 indicates a absence of recognition of mental states. A rating of 3 indicates a limited capacity to acknowledge mental states. A rating of 5 indicates the presence of a rudimentary capacity for reflective functioning.|post-treatment and 6-week follow up|Data analysis was conducted for ITT sample. Baseline data was available for 47 mothers. Missing post-tx and follow up scores for mothers who left treatment early were estimated as equal to baseline scores. Post-tx and follow up scores for mothers who completed treatment but not post-tx or follow up visits were estimated as equal to tx group means.||units on a scale||Standard Deviation|Mean
721612|NCT00319449|Secondary|High Density Lipoprotein-cholesterol (HDL-C), Total Cholesterol and Triglycerides at Baseline and After 6 Weeks of Treatment With Ezetimibe 10 mg Added to Atorvastatin 10 mg Versus Placebo Added to Atorvastatin 10 mg|12-hour fasting blood samples were collected in participants and the high density lipoprotein-cholesterol (HDL-C), triglycerides and total cholesterol was measured with the basic lipid panel test.|6 weeks post treatment|Participants who completed the study.||mg/dL||95% Confidence Interval|Mean
721613|NCT00319449|Secondary|Number of Participants Who Achieve the Target LDL-C Concentration of < 3.3 mmol/L (130 mg/dL)|12-hour fasting blood samples were collected in participants to measure high density lipoprotein-cholesterol (HDL-C), triglycerides and total cholesterol. LDL-C was measured using Friedewald calculation (LDL-C = Total C - [HDL-C + TG/5] after treatment for 6 weeks.|6 weeks post treatment|Participants who completed the study.||Participants|||Number
721614|NCT00319449|Primary|Low Density Lipoprotein-cholesterol (LDL-C) at Baseline and After 6 Weeks of Treatment With Ezetimibe 10 mg Added to Atorvastatin 10 mg Versus Placebo Added to Atorvastatin 10 mg|12-hour fasting blood samples were collected in participants to measure high density lipoprotein-cholesterol (HDL-C), triglycerides and total cholesterol. LDL-C was measured using Friedewald calculation (LDL-C = Total C - [HDL-C + TG/5]) before and after treatment.|Baseline and 6 weeks|Participants who completed the study.||mg/dL||95% Confidence Interval|Mean
721615|NCT00319501|Secondary|Mean Score on Physician Global Treatment Assessment During the Open-label Period|Physician global evaluation is based on seizure frequency, severity, and overall outcome compared with previous episodes and is rated on a 10-cm visual analogue scale, where 0=much worse and 10=much better. A higher score indicates greater improvement. An episode of acute repetitive seizures (ARS) is defined as an episode of multiple complex, partial, or generalized seizures occurring over a brief period (minutes to 12 hours) with the patient regaining consciousness between seizures, which were readily recognizable by the patient or a trained caregiver. ARS includes seizures sometimes referred to as serial, cluster, crescendo, or stuttering prolonged.|From Visit 2 and subsequent visits in the Open-label Period to discharge or study termination|All randomized participants for whom an attempt (successful or not) was made to administer study drug for an ARS event during the Open-label Period and who were available for evaluation.||Units on a scale||Standard Deviation|Mean
721616|NCT00319501|Secondary|Mean Score on Caregiver Global Treatment Assessment During the Open-label Period|Caregiver global evaluation is based on seizure frequency, severity, and overall outcome compared with previous episodes and is rated on a 10-cm visual analogue scale, where 0=much worse and 10=much better. A higher score indicates greater improvement. An episode of acute repetitive seizures (ARS) is defined as an episode of multiple complex, partial, or generalized seizures occurring over a brief period (minutes to 12 hours) with the patient regaining consciousness between seizures, which were readily recognizable by the patient or a trained caregiver. ARS includes seizures sometimes referred to as serial, cluster, crescendo, or stuttering prolonged.|Assessments completed at the end of each treated episode of ARS in the Open-label Period|All randomized participants for whom an attempt (successful or not) was made to administer study drug for an ARS event during the Open-label Period and who were available for participation.||Units on a scale||Standard Deviation|Mean
721617|NCT00319501|Secondary|Number of Participants Requiring Rescue Medical Care Other Than Medication or Emergency Department Visits During the Open-label Period|Other rescue medical care consisted of care other than rescue medication or emergency department visits. Each patient's specific criteria for seizure and an episode of acute repetitive seizure (ARS) were determined by the Investigator. Patients and their caregivers were trained to use these criteria to recognize the onset of an episode of ARS and when and how to administer study drug.|From 15 minutes to 12 hours after study drug administration for onset of an episode of ARS during the Open-label Period|All randomized participants for whom an attempt (successful or not) was made to administer study drug for an ARS event during the Double-blind Period.||Participants|||Number
721618|NCT00319501|Secondary|Number of Participants Requiring Emergency Department Visits During the Open-label Period|Any use of emergency treatment (such as an emergency room visit) was recorded in the patient’s diary, along with the date, time, and reason for the emergency treatment. Emergency department visits required some type of rescue action taken, other than the visit itself.|From 15 minutes to 12 hours after study drug administration for onset of an episode of ARS during the Open-label Period|All randomized participants for whom an attempt (successful or not) was made to administer study drug for an ARS event during the Open-label Period.||Participants|||Number
721619|NCT00319501|Secondary|Number of Participants Requiring Rescue Medication During the Open-label Period|Each patient's specific criteria for seizure and an episode of acute repetitive seizure (ARS) were determined by the Investigator. Patients and their caregivers were trained to use these criteria to recognize the onset of an episode of ARS and when and how to administer study drug. If seizure control following study drug administration was inadequate, diazepam rectal gel was provided as a rescue medication, given only in the first 4 hours after study drug administration and only if the caregiver was directed to do so by the Investigator or designee at the time of the ARS episode.|From 15 minutes to 12 hours after study drug administration during the Open-label Period|All randomized participants in whom an attempt (successful or not) was made to administer study drug for an ARS episode during the Open-label Period of the study.||Participants|||Number
721667|NCT00321763|Primary|Number of Subjects With New Onset of Chronic Diseases (NOCDs).|NOCDs include conditions such as diabetes, autoimmune disease, asthma, allergies etc. This table includes rare events, defined as events with an occurrence rate of 0.1 % and belonging to the NOCDs.|From Day 0 to Day 180|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||subjects|||Number
721620|NCT00319501|Secondary|Mean Score on Physician Global Treatment Assessment During the Double-blind Period|Physician global evaluation is based on seizure frequency, severity, and overall outcome compared with previous episodes. The physician global evaluation is rated on a 10-cm visual analogue scale, where 0=much worse and 10=much better. A higher score indicates greater improvement. An episode of acute repetitive seizures (ARS) was defined as an episode of multiple complex, partial, or generalized seizures occurring over a brief period (minutes to 12 hours) with the patient regaining consciousness between seizures, which were readily recognizable by the patient or a trained caregiver. ARS includes seizures sometimes referred to as serial, cluster, crescendo, or stuttering prolonged.|At Visit 2 and subsequent visits in the Double-blind Period|All randomized participants for whom an attempt (successful or not) was made to administer study drug for an episode of ARS during the Double-blind Period.||Units on a scale||Standard Deviation|Mean
721621|NCT00319501|Secondary|Mean Score on Caregiver Global Treatment Assessment During the Double-blind Period|Caregiver global evaluation is based on seizure frequency, severity, and overall outcome compared with previous episodes and is rated on a 10-cm visual analogue scale, where 0=much worse and 10=much better. A higher score indicates greater improvement. An episode of acute repetitive seizures (ARS) is defined as an episode of multiple complex, partial, or generalized seizures occurring over a brief period (minutes to 12 hours) with the patient regaining consciousness between seizures, which were readily recognizable by the patient or a trained caregiver. ARS includes seizures sometimes referred to as serial, cluster, crescendo, or stuttering prolonged.|Assessments completed at the end of each treated episode of ARS in the Double-blind Period|All randomized participants for whom an attempt (successful or not) was made to administer study drug for an episode of ARS during the Double-blind Period.||Units on a scale||Standard Deviation|Mean
721622|NCT00319501|Secondary|Number of Participants Requiring Rescue Medical Care Other Than Rescue Medication or Emergency Department Visits During the Double-blind Period|Other rescue medical care consisted of care other than rescue medication or emergency department visits. Each patient's specific criteria for seizure and an episode of acute repetitive seizure (ARS) were determined by the Investigator. Patients and their caregivers were trained to use these criteria to recognize the onset of an episode of ARS and when and how to administer study drug. An episode of ARS was defined as an episode of multiple complex, partial, or generalized seizures occurring over a brief period (minutes to 12 hours) with the patient regaining consciousness between seizures, which were readily recognizable by the patient or a trained caregiver. ARS includes seizures sometimes referred to as serial, cluster, crescendo, or stuttering prolonged.|From 15 minutes to 12 hours following study drug administration for an episode of ARS during the Double-blind Period|All randomized participants for whom an attempt (successful or not) was made to administer study drug for an ARS event during the Double-blind Period.||Participants|||Number
721623|NCT00319501|Secondary|Number of Participants Requiring Emergency Department Visits During the Double-blind Period|Any use of emergency treatment (such as an emergency room visit) was recorded in the patient’s diary, along with the date, time, and reason for the emergency treatment. Emergency department visits required some type of rescue action taken, other than the visit itself. An episode of acute repetitive seizures (ARS) was defined as an episode of multiple complex, partial, or generalized seizures occurring over a brief period (minutes to 12 hours) with the patient regaining consciousness between seizures, which were readily recognizable by the patient or a trained caregiver. ARS includes seizures sometimes referred to as serial, cluster, crescendo, or stuttering prolonged.|From 15 minutes to 12 hours following study drug administration for onset of an episode of ARS during the Double-blind Period|All randomized participants for whom an attempt (successful or not) was made to administer study drug for an episode of ARS during the Double-blind Period.||Participants|||Number
721624|NCT00319501|Secondary|Number of Participants Requiring Rescue Medication During the Double-blind Period|If seizure control following study drug administration was inadequate, diazepam rectal gel was provided as a rescue medication, given only in the first 4 hours after study drug administration and only if the caregiver was directed to do so by the Investigator or designee at the time of the acute repetitive seizure (ARS) episode. Each patient's specific criteria for seizure and an episode of ARS were determined by the Investigator. Patients and their caregivers were trained to use these criteria to recognize the onset of an episode of ARS and when and how to administer study drug. An episode of ARS was defined as an episode of multiple complex, partial, or generalized seizures occurring over a brief period (minutes to 12 hours) with the patient regaining consciousness between seizures, which were readily recognizable by the patient or a trained caregiver. ARS includes seizures sometimes referred to as serial, cluster, crescendo, or stuttering prolonged.|From 15 minutes to 12 hours following study drug administration for an episode of ARS during the Double-blind Period|All randomized participants for whom an attempt (successful or not) was made to administer study drug for an ARS during the Double-blind Period.||Participants|||Number
721625|NCT00319501|Primary|Percentage of Participants With an Event (Next Seizure or Rescue Medication) During the Open-label Period|An event was defined as an episode of or required rescue medication for an episode of acute repetitive seizures (ARS) within 15 minutes to 12 hours following study drug administration. Patients without an ARS event were censored at 12 hours. Diaries were provided; if no diary was returned, or the diary did not provide answers to questions about seizures and rescue during the 12-hour follow-up period, the patient was considered censored as of 15 minutes past the treatment time, unless another contact was documented. If seizure control following study drug administration was inadequate, diazepam rectal gel was provided as a rescue medication, given only in the first 4 hours after study drug administration and only if the caregiver was directed to do so by the Investigator or designee at the time of the ARS episode. Patients and their caregivers were trained to recognize the onset of an episode of ARS and when and how to administer study drug.|From 15 minutes to 12 hours after study drug administration for an episode of ARS during the Double-blind Period|All randomized participants for whom an attempt (successful or not) was made to administer study drug for an ARS event during the Open-label Period.||Percentage of participants|||Number
721685|NCT00321789|Primary|Low-density Lipoprotein Cholesterol|assessed with non-fasting blood test|11-month follow-up|||mg/dL||Standard Deviation|Mean
721686|NCT00321828|Secondary|Overall Survival as Measured by Death From Any Cause||Time from start of study through year 5||||||
721687|NCT00321828|Secondary|Serious Adverse Events (Grades 3, 4, and 5) as Defined by CTCAE v3.0||Time from start of study through year 5||||||
721626|NCT00319501|Primary|Time to Next Seizure or Rescue Medication During the Double-blind Period (Kaplan-Meier 50th Percentile)|An event was defined as an episode of or required rescue medication for an episode of acute repetitive seizures (ARS) within 15 minutes to 12 hours following study drug administration. Patients without an ARS event were censored at 12 hours. Diaries were provided; if no diary was returned, or the diary did not provide answers to questions about seizures and rescue during the 12-hour follow-up period, the patient was considered censored as of 15 minutes past the treatment time, unless another contact was documented. If seizure control following study drug administration was inadequate, diazepam rectal gel was provided as a rescue medication, given only in the first 4 hours after study drug administration and only if the caregiver was directed to do so by the Investigator or designee at the time of the ARS episode. Patients and their caregivers were trained to recognize the onset of an episode of ARS and when and how to administer study drug.|From 15 minutes to 12 hours after study drug administration for an episode of ARS during the Double-blind Period|All randomized participants for whom an attempt (successful or not) was made to administer study drug for an ARS event during the Double-blind Period.||Hours||95% Confidence Interval|Median
721627|NCT00319553|Primary|Geometric Mean Concentration of Antibody to Pertussis Antigens Pre- and Post-Vaccination With Adacel® or Boostrix®.||Day 0 and 28 days post-vaccination|Geometric mean concentration of antibody to the pertussis antigens were analyzed in the per-protocol population||EU/mL||95% Confidence Interval|Geometric Mean
721628|NCT00319553|Primary|Percentage of Participants With Diphtheria Antitoxin Concentrations ≥ 0.1 IU/mL Pre- and Post-Vaccination With Adacel® or Boostrix®.||Day 0 and 28 days post-vaccination|Diphtheria antitoxin concentrations were analyzed in the per-protocol population||Percentage of Participants|||Number
721629|NCT00319553|Primary|Percentage of Participants With Tetanus Antitoxin Concentrations ≥ 0.1 IU/mL Pre- and Post-Vaccination With Adacel® or Boostrix®.||Day 0 and 28 days post-vaccination|Tetanus antitoxin concentrations were analyzed in the per-protocol population.||Percentage of Participants|||Number
721630|NCT00319553|Primary|Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix®|"Solicited injection site reactions: Pain, Erythema, and swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.
Grade 3 reaction definitions: Pain = Incapacitating, unable to perform usual activities; Erythema and swelling = ≥ 5 cm; Fever = temperature ≥ 39.1°C or ≥ 102.3°F; Headache, Malaise, and Myalgia = Prevents daily activities."|Day 0 to 7 post-vaccination|Solicited injection site and Systemic reactions were analyzed in the intent-to-treat safety population||Participants|||Number
721631|NCT00319592|Primary|Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®|Grade 3 (severe) adverse events were defined as incapacitating with inability to work or perform usual activity.|Day 0 up to Day 6 post-vaccination|Adverse events were assessed in all participants who received at least one dose of study vaccine pr saline (Intent to Treat Population).||Participants|||Number
721632|NCT00319592|Primary|Mean Antibody Titers to the Respective Homologous JE Vaccine Strain Post Vaccination With Either ChimeriVax™-JE or JE-VAX®|Immunogenicity was determined by analyzing antibody response of subjects to the respective homologous JE vaccine strain using a serum dilution 50% plaque reduction neutralization test (PRNT50).|Day 0 (pre-vaccination) up to month 12 post-vaccination|Antibody titers were assessed in all participants who were seronegative at baseline, received the complete vaccine regimen, and had no significant protocol deviations (Per-Protocol Population).||1/dilutions||Standard Deviation|Mean
721633|NCT00319592|Primary|Number Participants That Were Seropositive to the Respective Homologous JE Vaccine Strain Before and Post-Vaccination With Either ChimeriVax™-JE or JE-VAX® Vaccine.|Immunogenicity was determined by analyzing antibody response of subjects to the respective homologous JE vaccine strain using a serum dilution 50% plaque reduction neutralization test (PRNT50). Seropositive status for the ChimeriVax™-JE group was based on the ChimeriVax™-JE virus strain and positive status for the JE-VAX® group was based on the Nakayama virus strain. Participants were defined as seropositive if they had an antibody titer of ≥ 1:10. [Seropositive status can be 'Yes' or 'No']|Day 0 (Pre-vaccination) and up to Month 12 After First Dose|Seropositive status was assessed in all participants who were seronegative at baseline, received the complete vaccine regimen, and had no significant protocol deviations (Per-Protocol Population).||Participants|||Number
721634|NCT00319592|Primary|Mean Antibody Titers of the Respective Homologous JE Vaccine Strain After the First Active Vaccination With Either JE-Vax ® or ChimeriVax™-JE|Immunogenicity was determined by analyzing antibody response of subjects to the respective homologous JE vaccine strain using a serum dilution 50% plaque reduction neutralization test (PRNT50).|Day 0 up to Day 56 post-vaccination|Antibody titers were assessed in all participants who were seronegative at baseline, received the complete vaccine regimen, and had no significant protocol deviations (Per Protocol Population).||1/dilutions||Standard Deviation|Mean
721635|NCT00319592|Primary|Number of Participants Who Seroconverted to the Respective Homologous JE Vaccine Strain Up to 28 Days After the First Active Vaccination With Either ChimeriVax™-JE or JE-VAX® Vaccine|Immunogenicity was determined by analyzing antibody response of subjects to the respective homologous JE vaccine strain using a serum dilution 50% plaque reduction neutralization test (PRNT50). Seroconversion was defined as a 4 fold increase in antibody titer of ≥ 1:10 at baseline, or an antibody titer of ≥ 1:10 for participants with a baseline antibody titer of < 1:10.|Day 0 (pre-vaccination) and up to Day 56 post-vaccination|Seroconversion was assessed in all participants who were seronegative at baseline, received the complete vaccine regimen, and had no significant protocol deviations (Per-Protocol Population).||Participants|||Number
721636|NCT00319644|Primary|Antibiotics Exposure Days|We hypothesize that Mini-BAL quantitative culture in place of tracheal aspirate culture will reduce the total days of antibiotics exposure|15 days|Random||days||Standard Deviation|Mean
721652|NCT00321698|Primary|Pathologic Response Rate at the Phase II Dose|"Pathologic response rate is determined post-prostatectomy by pathologist laboratory analyses. The TNM system is the most widely used cancer staging system. Most hospitals and medical centers use the TNM system as their main method for cancer reporting. In the TNM system:
The T refers to the size and extent of the main/primary tumor. T1, T2, T3, T4: Refers to the size and/or extent of the main tumor. The higher the number after the T, the larger the tumor or the more it has grown into nearby tissues. T's may be further divided to provide more detail, such as T3a and T3b."|4-6 weeks after study treatment|||participants|||Number
721637|NCT00319644|Primary|Change in Antibiotic Usage or Exposure|We expect that 100-110 adult patients will have clinically suspected VAP over a 2-year period. We assume that 50 patients with suspected VAP will be randomized to mini-BAl, and 50 patients will be randomized to tracheal aspirate. We expect that patients randomized to tracheal aspirate group will receive an average of approximately 14 total days of antibiotics over their ICU stay. This study will have >80% power to detect a difference of 4 days of antibiotics (i.e. average of 10 days in mini-BAL group) with a 7-day standard deviation in both groups (alpha error level 5%).|It is theorized that patients randomized to the tracheal aspirate will receive an average of 15 days of antibiotics while patients randomized under the minibal arm will receive an average of 10 days of antibiotics|Of the 37 adult critically ill patients, 21 belonged to the tracheal aspirate (TA) group and 16 patients were classified as mini-BAL (MB) group.||days||Standard Deviation|Mean
721638|NCT00321672|Secondary|Proportion of Subjects Reaching 30% Decrease in Their Mean “Average Pain for the Past 24 Hours” Numeric Pain Rating Scale (NPRS) Score From Baseline During Weeks 2 to 12||Weeks 2-12|||Percentage of Participants|||Number
721639|NCT00321672|Secondary|Absolute Change in the Mean “Average Pain for the Past 24 Hours” Numeric Pain Rating Scale (NPRS) Score From Baseline During Weeks 2 to 12.||Weeks 2-12.|||Numeric Pain Rating Scale (0 to 10)||Standard Error|Least Squares Mean
721640|NCT00321672|Primary|The Primary Measure of Efficacy Was the Percent Change in the “Average Pain for the Past 24 Hours” Numeric Pain Rating Scale (NPRS) Score From Baseline During Weeks 2 to 12.|"Efficacy was assessed by daily Numeric Pain Rating Scale (NPRS) capturing average pain for the past 24 hours for painful HIV-associated neuropathy area(s) at approximately 9 PM every evening throughout the 12-week study period. The NPRS is an 11-point scale (0 to 10) with 0 indicating no pain and 10 indicating the worst possible pain."|Weeks 2-12|Analyses were intention to treat (ITT). A modified last observation carried forward (LOCF) approach was used to impute missing data. Each NGX-4010 group was compared with its respective control group.||Percent Change from baseline||Standard Error|Least Squares Mean
721646|NCT00321698|Secondary|Clinical Progression-free Rate as Determined by <0.1ng PSA Results|The estimated percentage of participants who were progression-free at 5 years per analyses of PSA results post-study treatment.|3, 6, 9, 12 months and annually, up to 5 years|||percentage of participants||95% Confidence Interval|Number
721647|NCT00321698|Secondary|Efficacy Assessed Using Health-Related Quality of Life by Expanded Prostate Cancer Index Composite and Urinary Symptom Scores by American Urological Association's Measures|"Mean change in score from Baseline to 12-months pot-op. A single outcome, Health Related Quality of Life (QOL), was specified in the protocol. All 6 score means and confidence intervals are reported here as a single outcome; a separate row for each score.
AUA Symptom Score is designed to measure lower urinary tract symptoms (LUTS) resulting from benign prostatic hyperplasia or other causes in men. Higher scores indicate more LUTS (scale 0-35). 1-7, mild; 8-19, moderate; 20-35, severe.
EPIC quality of life instruments is a 32-item self-report questionnaire that measures the QOL of prostate cancer patients. 4 subscales measuring urinary (further consisting of two sub-components, EPIC Urinary Incontinence Score and EPIC Urinary Obstructive/Irritative Score), bowel, sexual and hormonal changes. Scores for each of the subscales, as well as for each sub-component within the Urinary sub scale, are transformed linearly to a 0-100 scale with higher scores representing better QOL."|Baseline and 12 Months Post-Prostatectomy|Scores not available for some participants||units on a scale||95% Confidence Interval|Mean
721648|NCT00321698|Secondary|Surgical Margin Status at Time of Prostatectomy (Count of Subjects With Negative Surgical Margins)|"Pathologic response rate is determined post-prostatectomy by pathologist laboratory analyses. The TNM system is the most widely used cancer staging system. Most hospitals and medical centers use the TNM system as their main method for cancer reporting. In the TNM system:
The M refers to whether the cancer has metastasized. This means that the cancer has spread outside of the primary tumor to other parts of the body."|5 weeks|For Phase I Dose 1-4, all participants were combined for this assessment as pre-specified in the protocol.||Participants|||Count of Participants
721649|NCT00321698|Secondary|Clinical Response to Treatment as Measured by Urologic Examination||Regular intervals (clinical contact)||12/2020||||
721650|NCT00321698|Secondary|Long-term Safety||Regular intervals (clinical contact)||12/2020||||
721653|NCT00321698|Primary|Maximum Tolerated Dose (MTD)|"Maximal tolerated dose (MTD) of the combination radiation (45 Gy) and docetaxel.
The dose of radiation will be fixed at 45 Gy while the dose of docetaxel will be escalated. The starting dose of docetaxel will be 10 mg/m2 and will be escalated in increments of 10 mg/m2 up to a dose of 30 mg/m2 the pre-planned ceiling).
MTD will be the dose that is associated with no more than 1 dose limiting toxicity (DLT) up to 6 patients. The DLT will be defined as clinically significant grade 3 non-hematologic or grade 4 hematologic toxicity, attributable to the chemoirradiation. If 2 of 3 patients experience a DLT, dose escalation will stop and the previous dose level will be considered the MTD. If 1 of 3 has DLT, additional 3 patients will be enrolled at the same dose level. If none of the additional 3 patients has DLT, the dose escalation will continue. If 1 additional patient has DLT, the previous dose will be considered the MTD and dose escalation will be stopped."|5 weeks|||mg/m^2|||Number
721654|NCT00321711|Secondary|Platelet Transfusion|Occurrence of one or more platelet transfusions from study day 1 through the interim follow-up visit (16 weeks)|Study day 1 through the interim follow-up visit (up to 20 weeks)|Full Analysis Set, composed of all randomized participants||Participants|||Number
721655|NCT00321711|Secondary|Achieving an Overall Response (Complete or Partial Response, CR or PR) at the End of the Treatment Period|CR = decrease in bone marrow blast (≤5%) and improvement in peripheral blood counts (Hgb ≥ 11 g/dL, platelets ≥ 100x10^9/L, neutrophils ≥ 1x10^9/L, peripheral blasts=0%). PR = improvement in peripheral blood counts plus a decrease in bone marrow blasts ≥50% but not ≤5, or decrease in International Prognostic Scoring System score.|Treatment period (up to 20 weeks)|Full Analysis Set, composed of all randomized participants||Participants|||Number
721656|NCT00321711|Secondary|Hypomethylating Agent Dose Reduction and Delay Due to Thrombocytopenia|Occurrence of hypomethylating agent dose reduction and delay due to thrombocytopenia|Treatment period (up to 20 weeks)|Full Analysis Set, composed of all randomized participants||Participants|||Number
721657|NCT00321711|Primary|Occurrence of a Clinically Significant Thrombocytopenic Event|Occurrence of a clinically significant thrombocytopenic event within the participant, defined as any platelet count obtained from day 15 of cycle 1 through the end of the interim follow-up visit that was less than 50 x 10^9/L or receipt of platelet transfusions at any time through the interim follow-up visit.|Treatment period (up to 20 weeks)|Full Analysis Set, composed of all randomized participants||Participants|||Number
721658|NCT00321737|Secondary|Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Mean.|The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.|6 months|The analysis was performed on ITT subjects with at least one nighttime heartburn Yes/No question answered during treatment.||Percentage of Days||Standard Deviation|Mean
721659|NCT00321737|Secondary|Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Median.|The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.|6 months|The analysis was performed on ITT subjects with at least one nighttime heartburn Yes/No question answered during treatment.||Percentage of Days||Inter-Quartile Range|Median
721660|NCT00321737|Primary|Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Life Table Method|Percentage of subjects who maintained complete healing of erosive esophagitis as assessed by endoscopy. In the life table method, subjects without post-baseline endoscopy were included as censored; subjects who did not have a recurrence of EE and did not complete the study were also considered censored.|6 months|Life table method for the maintenance rate of healed EE was performed on ITT subjects and included subjects without post-baseline endoscopy as censored.||Percentage of Subjects|||Number
721661|NCT00321737|Secondary|Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Mean.|The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked.|6 months|The analysis of 24-hour heartburn-free days was performed on ITT subjects with at least one daytime or nighttime heartburn Yes/No question answered during treatment.||Percentage of Days||Standard Deviation|Mean
721662|NCT00321737|Secondary|Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Median.|The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was reported.|6 months|The analysis of 24-hour heartburn-free days was performed on ITT subjects with at least one daytime or nighttime heartburn Yes/No question answered during treatment.||Percentage of Days||Inter-Quartile Range|Median
721663|NCT00321737|Primary|Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Crude Rate Analysis.|Crude rates analyzed maintenance of healed EE from baseline of this study and considered prematurely discontinued subjects as relapsed.|6 months|The crude rate analysis was performed on intent-to-treat (ITT) subjects (subjects from Studies T-EE04-084 or T-EE04-085 with endoscopically proven healed EE who received at least 1 dose of study drug in this study and did not have a gap of >7 days between the EE healing studies and this study) with at least one endoscopy in this maintenance study.||Percentage of Subjects|||Number
721664|NCT00321763|Primary|Number of Subjects With Any and Related Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any = any SAE regardless of intensity or relationship to vaccination. Related (REL) = SAE assessed by the investigator as related to the vaccination.|During the entire study period (Days 0-180)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||subjects|||Number
721665|NCT00321763|Primary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented normal activity Related = unsolicited AE assessed by the investigator as related to the vaccination. This table includes rare events, defined as events with an occurrence rate of 0.1 % and belonging to the AEs.|During the 30-day (Days 0-29) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||subjects|||Number
721688|NCT00321828|Secondary|Local Complications as Assessed by Other Events Related to the Intact Primary Tumor Which Require Hospitalization But Not Surgery||Time from start of study through year 5||||||
721668|NCT00321763|Primary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.|Assessed solicited general symptoms were arthralgia, fatigue, fever [oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, muscle aches and shivering. Any = incidence of a particular symptom regardless of grade intensity or relationship with the study vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0°C. Related = symptom considered by the investigator to have a causal relationship to study vaccination.|During the 7-day (Days 0-6) post vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with a documented dose and with symptom sheets completed .||subjects|||Number
721669|NCT00321763|Primary|Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.|Assessed solicited local symptoms were ecchymosis, pain, redness and swelling at injection site. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling/ecchymosis = redness/swelling/ecchymosis spreading beyond 50 millimeters (mm) of the injection site. All solicited local symptoms were assessed by the investigator as being related to study vaccination.|During the 7-day (Days 0-6) post vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with a documented dose and with symptom sheets completed .||subjects|||Number
721670|NCT00321763|Primary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 3 assessed influenza strains were A/New Caledonia, A/New York and B/Malaysia. The results for the GSK1247446A Lot 1, 2, 3 and Pooled Groups are the primary efficacy variables.|At Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||fold increase||95% Confidence Interval|Geometric Mean
721671|NCT00321763|Primary|Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.|A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 3 assessed influenza strains were A/New Caledonia, A/New York and B/Malaysia. The results for the GSK1247446A Lot 1, 2, 3 and Pooled Groups are the primary efficacy variables.|At Days 0 and 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||subjects|||Number
721672|NCT00321763|Primary|Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 assessed influenza strains were A/New Caledonia, A/New York and B/Malaysia. The results for the GSK1247446A Lot 1, 2, 3 and Pooled Groups are the primary efficacy variables.|At Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||subjects|||Number
721673|NCT00321763|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/New Caledonia, A/New York and B/Malaysia. The seropositivity cut-off assay was 1:10. The results for the GSK1247446A Lot 1, 2, 3 and Pooled Groups are the primary efficacy variables.|At Days 0 and 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||titers||95% Confidence Interval|Geometric Mean
721674|NCT00321789|Secondary|Number of Participants Prescribed Cholesterol Medication|This was assessed via electronic medical record abstraction. Results could not be modeled statistically due to missing data/small cell sizes (i.e., not all participants had a prescription for medication because this was not an inclusion criterion).|11-month follow-up|||participants|||Number
721675|NCT00321789|Secondary|Number of Participants With Goal LDL-C|Assessed via non-fasting blood test. Goal is determined by 2003 National Cholesterol Education Program guidelines. Goal could be 160mg/dL for low risk (no coronary heart disease (CHD), 0-1 risk factor); 130 mg/dL for medium risk (no CHD, at least 2 risk factors); or 100 mg/dL for high risk (CHD and risk equivalents including diabetes, atherosclerotic disease, and multiple risk factors that confer a 10-year risk for CHD >20% per Framingham score).|11-month follow-up|||participants|||Number
721676|NCT00321789|Secondary|Saturated Fat (%)|Self-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ).|11-month follow-up|||percentage of calories||Standard Deviation|Mean
721677|NCT00321789|Secondary|Total Fat (%)|Self-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ).|11-month follow-up|||percentage of calories||Standard Deviation|Mean
721678|NCT00321789|Secondary|Duration of Moderate Intensity Physical Activity|Self-reported via Community Health Activities Model Program for Seniors questionnaire.|11-month follow-up|||hours per week||Inter-Quartile Range|Median
721679|NCT00321789|Secondary|Frequency of Moderate Intensity Physical Activity|Self-reported via Community Health Activities Model Program for Seniors questionnaire.|11-month follow-up|||times per week||Inter-Quartile Range|Median
721680|NCT00321789|Secondary|Fiber Intake|Self-reported, assessed via Block Brief Food Frequency Questionnaire.|11-month follow-up|||grams per day||Standard Deviation|Mean
721681|NCT00321789|Secondary|Cholesterol Intake|Self-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ).|11-month follow-up|||milligrams per day||Standard Deviation|Mean
721682|NCT00321789|Secondary|Total Fat (Grams/Day)|Self-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ).|11-month follow-up|||grams per day||Standard Deviation|Mean
721683|NCT00321789|Secondary|Saturated Fat (Grams/Day)|Self-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ).|11-month follow-up|||grams per day||Standard Deviation|Mean
721684|NCT00321789|Secondary|Caloric Intake|Self-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ).|11-month follow-up|||kcal/day||Standard Deviation|Mean
721692|NCT00321828|Primary|Major Morbidity Related to the Intact Primary Tumor|Cumulative incidence was used to compute percent probability of morbidity. Cumulative incidence at time t measures the probability of a participant having an event (i.e., Colonic bleeding, perforation, bowel obstruction, or fistula formation requiring surgery or resulting in patient death) over the given duration, t. It involves computing the probability of an event at any observed time (i.e., the number of new cases during a period divided by the number of subjects at risk) and multiplying these successive probabilities by any early computed probability to get the final estimate.|24 months|||probability of major morbidity (%)||95% Confidence Interval|Number
721693|NCT00321854|Secondary|Clinically Significant Abnormalities in Vital Signs||Baseline and Month 15|Phase 1 Treated set for sinus bradycardia with N of 261 for Early PPX and 274 for Delayed PPX. Phase 2 Treated set for hypotension with N of 221 for Early PPX and 214 for Delayed PPX.||percentage of participants|||Number
721694|NCT00321854|Secondary|Clinically Significant Abnormalities in Clinical Laboratory Measurements - Substrates||Baseline and Month 15|Glucose-N was 28 for Early PPX and 46 for Delayed PPX, Cholesterol and Triglyceride-N was 213 for Early PPX and 208 for Delayed PPX, Blood Urea Nitrogen-N was 214 for Early PPX and 209 for Delayed PPX, Creatinine-N was 200 for Early PPX and 202 for Delayed PPX, Uric Acid-N was 212 for Early PPX and 209 for Delayed PPX.||percentage of participants|||Number
721695|NCT00321854|Secondary|Clinically Significant Abnormalities in Clinical Laboratory Measurements - Enzymes||Baseline and Month 15|Gamma Glutamyltranspeptidase (GGT-N) was 214 for Early PPX and 208 for Delayed PPX, Amylase-N was 214 for Early PPX and 209 for Delayed PPX||percentage of participants|||Number
721696|NCT00321854|Secondary|Clinically Significant Abnormalities in Clinical Laboratory Measurements - Haematology and Electrolytes||Baseline and Month 15|Treated set: Haematocrit and mean corpuscular volume (MCV-N) was 211 for Early PPX and 209 for Delayed PPX, Haemoglobin-N was 213 for Early PPX and 212 for Delayed PPX, Sodium-N was 211 for Early PPX and 209 for Delayed PPX, Calcium and Chloride-N was 214 for Early PPX and 209 for Delayed PPX, Phosphate-N was 201 for Early and Delayed PPX||percentage of participants|||Number
721697|NCT00321854|Secondary|Percentage Change From Baseline in the Striatum Uptake at Month 15|The striatum beta-carbomethoxy-iodophenyl-tropane (beta-CIT) uptake was calculated as mean of the left and right caudate and putamen regions; measured by the Single-Photon Emission Computed Tomography (SPECT).|Baseline and Month 15|The substudy set was made up of all randomised patients with a baseline and end of treatment assessment of striatal uptake.||Percentage change||Standard Error|Least Squares Mean
721698|NCT00321854|Secondary|Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 15|The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a.|Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 134 patients from the FAS2 were excluded due to insufficient MMIDI data.||Participants|||Number
721699|NCT00321854|Secondary|Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 12|The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a.|Month 12|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 140 patients from the FAS2 were excluded due to insufficient MMIDI data.||Participants|||Number
721700|NCT00321854|Secondary|Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 9|The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a.|Month 9|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 131 patients from the FAS2 were excluded due to insufficient MMIDI data.||Participants|||Number
721701|NCT00321854|Secondary|Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 6|The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a.|Month 6|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 131 patients from the FAS2 were excluded due to insufficient MMIDI data.||Participants|||Number
721702|NCT00321854|Secondary|Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 1|The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a.|Month 1|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 132 patients from the FAS2 were excluded due to insufficient MMIDI data.||Participants|||Number
721703|NCT00321854|Secondary|Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 15|The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4.|Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 134 patients from the FAS2 were excluded due to insufficient MMIDI data.||Participants|||Number
721704|NCT00321854|Secondary|Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 12|The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4.|Month 12|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 140 patients from the FAS2 were excluded due to insufficient MMIDI data.||Participants|||Number
722029|NCT00323492|Primary|Change From Baseline to Week 12 in Fasting Low-density Lipoprotein Cholesterol (LDL-CHO)|Centralized laboratory assessment. Change = Week 12 value minus baseline value.|Baseline to Week 12|ITT. LOCF method was used for the analysis if the Week 12 value was missing. A missing datum were replaced by the last post-baseline value.||mmol/L||Inter-Quartile Range|Median
721705|NCT00321854|Secondary|Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 9|The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4.|Month 9|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 131 patients from the FAS2 were excluded due to insufficient MMIDI data.||Participants|||Number
721706|NCT00321854|Secondary|Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 6|The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4.|Month 6|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 131 patients from the FAS2 were excluded due to insufficient MMIDI data.||Participants|||Number
721707|NCT00321854|Secondary|Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 1|The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4.|Month 1|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 132 patients from the FAS2 were excluded due to insufficient MMIDI data.||Participants|||Number
721708|NCT00321854|Secondary|Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 15|The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12.|Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 134 patients from the FAS2 were excluded due to insufficient MMIDI data.||Participants|||Number
721709|NCT00321854|Secondary|Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 12|The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12.|Month 12|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 140 patients from the FAS2 were excluded due to insufficient MMIDI data.||Participants|||Number
721710|NCT00321854|Secondary|Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 9|The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12.|Month 9|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 131 patients from the FAS2 were excluded due to insufficient MMIDI data.||Participants|||Number
721711|NCT00321854|Secondary|Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 6|The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12.|Month 6|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 131 patients from the FAS2 were excluded due to insufficient MMIDI data.||Participants|||Number
721712|NCT00321854|Secondary|Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 1|The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12.|Month 1|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 132 patients from the FAS2 were excluded due to insufficient MMIDI data.||Participants|||Number
721713|NCT00321854|Secondary|Change From Baseline in the European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Score at Month 9|The EQ-VAS is a self rating of current health-related quality of life measured on a continuous scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state)|Baseline and Month 9|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 5 patients from the FAS2 were excluded due to insufficient efficacy data.||Units on a scale||Inter-Quartile Range|Median
721714|NCT00321854|Secondary|Change From Baseline in the European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Score at Month 15|The EQ-VAS is a self rating of current health-related quality of life measured on a continuous scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state)|Baseline and Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 2 patients from the FAS2 were excluded due to insufficient efficacy data.||Units on a scale||Inter-Quartile Range|Median
721715|NCT00321854|Secondary|Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Month 9|The EQ-5D measures health status on a continuous scale ranging from 0 (dead) to 1 (full health)|Baseline and Month 9|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 3 patients from the FAS2 were excluded due to insufficient efficacy data.||Units on a scale||Inter-Quartile Range|Median
721716|NCT00321854|Secondary|Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Month 15|The EQ-5D measures health status on a continuous scale ranging from 0 (dead) to 1 (full health)|Baseline and Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.||Units on a scale||Inter-Quartile Range|Median
721730|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 3|The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability)|Baseline and Month 3|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 3 patients from the FAS2 were excluded due to insufficient efficacy data.||Units on a scale||Standard Error|Least Squares Mean
721717|NCT00321854|Secondary|Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Month 9|The PDQ-39 measures aspects of health in PD participants, the overall index score is the mean of the eight individual domain scores measured on a continuous scale ranging from 0 (no problem at all) to 100 (maximum level of the problem)|Baseline and Month 9|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 3 patients from the FAS2 were excluded due to insufficient efficacy data.||Units on a scale||Inter-Quartile Range|Median
721718|NCT00321854|Secondary|Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Month 15|The PDQ-39 measures aspects of health in PD participants, the overall index score is the mean of the eight individual domain scores measured on a continuous scale ranging from 0 (no problem at all) to 100 (maximum level of the problem)|Baseline and Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial.||Units on a scale||Inter-Quartile Range|Median
721719|NCT00321854|Secondary|Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 3|The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)|Baseline and Month 3|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 2 patients from the FAS2 were excluded due to insufficient efficacy data.||Units on a scale||Standard Error|Least Squares Mean
721720|NCT00321854|Secondary|Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 6|The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)|Baseline and Month 6|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.||Units on a scale||Standard Error|Least Squares Mean
721721|NCT00321854|Secondary|Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 9|The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)|Baseline and Month 9|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.||Units on a scale||Standard Error|Least Squares Mean
721722|NCT00321854|Secondary|Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 15|The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)|Baseline and Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 3 patients from the FAS2 were excluded due to insufficient BDI data.||Units on a scale||Standard Error|Least Squares Mean
721723|NCT00321854|Secondary|Change From Baseline in Blinded Rater Assessment of Clinical Global Impressions of Severity of Illness (CGI-S) Category at Month 15|The CGI-S measures the participants severity of illness on an ordinal scale ranging from 1 (normal) to 7 (extremely ill). At Month 15 participants were categorised to 'Improved' (>1 category improvement), 'Unchanged' or 'Worsened' (>1 category worsening).|Baseline and Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 4 patients from the FAS2 were excluded due to insufficient CGI-I data.||Participants|||Number
721724|NCT00321854|Secondary|Number of Responders Using the Blinded Rater Assessment of Clinical Global Impressions of Global Improvement (CGI-I) Score at Month 15|The CGI-I measures the overall improvement in the participants condition from baseline on an ordinal scale ranging from 1 (very much improved) to 7 (very much worse). Responders are defined as those patients with a CGI-I of 1 or 2.|Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 27 patients from the FAS2 were excluded due to insufficient CGI-I data.||Participants|||Number
721725|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 3|The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability)|Baseline and Month 3|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 3 patients from the FAS2 were excluded due to insufficient efficacy data.||Units on a scale||Standard Error|Least Squares Mean
721726|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 6|The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability)|Baseline and Month 6|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.||Units on a scale||Standard Error|Least Squares Mean
721727|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 9|The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability)|Baseline and Month 9|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.||Units on a scale||Standard Error|Least Squares Mean
721728|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 15|The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability)|Baseline and Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.||Units on a scale||Standard Error|Least Squares Mean
721729|NCT00321854|Secondary|Change From Baseline in the Blinded Rater UPDRS Part I Total Score at Month 15|The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability)|Baseline and Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial||Units on a scale||Standard Error|Least Squares Mean
721731|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 6|The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability)|Baseline and Month 6|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.||Units on a scale||Standard Error|Least Squares Mean
721732|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 9|The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability)|Baseline and Month 9|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.||Units on a scale||Standard Error|Least Squares Mean
721733|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 15|The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability)|Baseline and Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.||Units on a scale||Standard Error|Least Squares Mean
721734|NCT00321854|Secondary|Change From Baseline in the Blinded Rater UPDRS Part II Total Score at Month 15|The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability)|Baseline and Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial||Units on a scale||Standard Error|Least Squares Mean
721735|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 3|The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability)|Baseline and Month 3|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 3 patients from the FAS2 were excluded due to insufficient efficacy data.||Units on a scale||Standard Error|Least Squares Mean
721736|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 6|The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability)|Baseline and Month 6|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.||Units on a scale||Standard Error|Least Squares Mean
721737|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 9|The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability)|Baseline and Month 9|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.||Units on a scale||Standard Error|Least Squares Mean
721738|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 15|The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability)|Baseline and Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.||Units on a scale||Standard Error|Least Squares Mean
721739|NCT00321854|Secondary|Change From Baseline in the Blinded Rater UPDRS Part III Total Score at Month 15|The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability)|Baseline and Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial||Units on a scale||Standard Error|Least Squares Mean
721740|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 3|The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability)|Baseline and Month 3|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 3 patients from the FAS2 were excluded due to insufficient efficacy data.||Units on a scale||Standard Error|Least Squares Mean
721741|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 6|The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability)|Baseline and Month 6|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.||Units on a scale||Standard Error|Least Squares Mean
721742|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 9|The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability)|Baseline and Month 9|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.||Units on a scale||Standard Error|Least Squares Mean
721743|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 15|The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability)|Baseline and Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.||Units on a scale||Standard Error|Least Squares Mean
722155|NCT00307489|Primary|Percentage of Participants With Plasma HBV DNA < 169 Copies/mL at Week 48||48 weeks|Randomized and Treated (RAT) subjects at Week 48 - Non-Completers=Failure (ie, includes subjects who switched to open-label FTC/TDF at or after Week 24)||percentage of participants|||Number
721744|NCT00321854|Secondary|Change From Baseline in the Blinded Rater UPDRS Parts II+III Total Score at Month 15|The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability)|Baseline and Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial||Units on a scale||Standard Error|Least Squares Mean
721745|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Total Score at Month 3|The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability)|Baseline and Month 3|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 3 patients from the FAS2 were excluded due to insufficient efficacy data.||Units on a scale||Standard Error|Least Squares Mean
721746|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Total Score at Month 6|The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability)|Baseline and Month 6|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.||Units on a scale||Standard Error|Least Squares Mean
721747|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Total Score at Month 9|The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability)|Baseline and Month 9|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.||Units on a scale||Standard Error|Least Squares Mean
721748|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Total Score at Month 15|The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability)|Baseline and Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.||Units on a scale||Standard Error|Least Squares Mean
721749|NCT00321854|Primary|Change From Baseline in the Blinded Rater Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Month 15|The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability)|Baseline and Month 15|The Phase 2 Full Analysis Set (FAS2) was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial||Units on a scale||Standard Error|Least Squares Mean
721750|NCT00321893|Primary|Participant Overall Response (by Tumor Type Subsolid or Solid Tumor) as Measured by RECIST Criteria at 12 Months|Number of participants with response according to RECIST criteria. For single nodules > 5 mm, clinical meaningful shrinkage of 30% or > of longest diameter (LD) considered treatment success after 1 year of treatment. For single nodules with LD <5 mm, complete disappearance considered treatment success. In case of multiple lesions success of treatment is when complete response (CR) or partial response (PR) occurs according to RECIST criteria.|12 Months|Per person analysis. Excluded from analysis were three participants in Arm I: Budesonide and one participant in Arm II: Placebo who refused the follow up Computed Tomography (CT) scan.||participants|||Number
721751|NCT00321893|Primary|Number of Participant Overall Responses as Measured by RECIST Criteria at 12 Months|For single nodules >5 mm, clinical meaningful shrinkage of 30% or > longest diameter (LD) considered treatment success after 1 year treatment; for <5 mm, complete disappearance considered treatment success. Multiple lesions success is complete response (CR) or partial response (PR) according to RECIST while failure when progression disease (PD) or stable disease (SD). CR: disappearance all target & non target lesions + no appearance new lesions; PR: CR for target lesions+incomplete/SD for non target lesions+no new lesions or PR (i.e., 30%<sum LD target lesions) for target lesions + no PD for non target lesions + no appearance of new lesions; PD: PD (at least 20% > sum LD of target lesions) for target lesions irrespective of response of non target lesions or PD for non target lesions irrespective of response for target lesions/or appearance new lesions irrespective of response of target/or non target lesions; SD: neither sufficient shrinkage for PR nor increase for PD.|12 Months|Per person analysis. Excluded from analysis were three participants in Arm I: Budesonide and one participant in Arm II: Placebo who refused the Computed Tomography (CT) scan.||participants|||Number
721752|NCT00321893|Primary|Size of CT- Detected Lung Nodules by Participant|Lung nodules (nodule characteristics) in a person-specific analysis by Response Evaluation Criteria In Solid Tumors (RECIST) criteria using Computed Tomography (CT) detection. Nodule type categorized as: Nonsolid, Partially Solid, or Solid. Persistent lung nodules detected at CT scan from previous year with 1 of following: longest diameter between 4&5 mm. Nodules may be stable or grown from the previous year (< 5 mm does not require additional diagnostic follow-up); longest diameter between 5.1& 8mm. Nodules may be stable or grown from the previous year. If grown, doubling time should be >1 year; longest diameter > 8 mm with negative positron positron emission tomography (PET) scan, negative CT enhancement. Nodule should have grown with doubling time between 1& 5 years; -longest diameter >8mm, non solid or partially solid nodules, stable or grown with doubling time between 1&5 years|Baseline assessment|Per person analysis. Per person analysis in overall randomized study (202 participants) using identification (baseline) CT.||lung nodules|Participants||Number
721767|NCT00321919|Secondary|Mean Change From Baseline in Left Ventricular Volume (LV Volume )|Left Ventricular Volume is the estimated of left ventricular end-diastolic volume (LVEDv) and left ventricular end-systolic volume (LVESV) determined by Echocardiogram. The change was calculated as week value minus baseline value.|Baseline, Week 12, Week 24, Week 36, and Week 48|The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received. The “n” represents the number of participants assessed for LV Volume at Baseline, Week 12, Week 24, Week 36 and Week 48.||milliliters per meter square||Standard Deviation|Mean
721753|NCT00321893|Primary|Number CT- Detected Lung Nodules by Participant|Lung nodules (nodule characteristics) in a person-specific analysis by Response Evaluation Criteria In Solid Tumors (RECIST) criteria using Computed Tomography (CT) detection: Persistent lung nodules detected at CT scan from previous year with 1 of following: longest diameter between 4&5 mm. Nodules may be stable or grown from the previous year (< 5 mm does not require additional diagnostic follow-up); longest diameter between 5.1& 8mm. Nodules may be stable or grown from the previous year. If grown, doubling time should be >1 year; longest diameter > 8 mm with negative positron positron emission tomography (PET) scan, negative CT enhancement. Nodule should have grown with doubling time between 1& 5 years; -longest diameter >8mm, non solid or partially solid nodules, stable or grown with doubling time between 1&5 years. Participants followed from baseline to 3 Years, follow up CT assessment planned at 12 months.|Baseline assessment|Per person analysis in overall randomized study (202 participants) using identification (baseline) CT.||lung nodules|Participants||Number
721754|NCT00321906|Secondary|Overall Survival at 36 Months|Kaplan-Meier estimate of proportion of patients that survived to (i.e., had not died by) 36 months.|36 mos|||percentage of participants|||Number
721755|NCT00321906|Secondary|Overall Survival at 24 Months|Kaplan-Meier estimate of proportion of patients that survived to (i.e., had not died by) 24 months.|24 mos|||percentage of participants|||Number
721756|NCT00321906|Secondary|Overall Survival at 12 Months|Kaplan-Meier estimate of proportion of patients that survived to (i.e., had not died by) 12 months.|12 mos|||percentage of participants|||Number
721757|NCT00321906|Secondary|Bronchiolitis Obliterans Syndrome (BOS) at 36 Months|Kaplan-Meier estimate of proportion of patients that had not experienced BOS by 36 months.|36 mos|||percentage of participants|||Number
721758|NCT00321906|Secondary|Bronchiolitis Obliterans Syndrome (BOS) at 24 Months|Kaplan-Meier estimate of proportion of patients that had not experienced BOS by 24 months.|24 mos|||percentage of participants|||Number
721759|NCT00321906|Secondary|Severity of Acute Rejection at 12 Months|"Raw proportion of patients that experienced rejection at or above grade A2 by 12 months.
Grade A0 - None With/Without Grade A1 - Minimal Grade A2 - Mild Grade A3 - Moderate"|12 mos|||percentage of participants|||Number
721760|NCT00321906|Secondary|Acute Rejection-free Survival at 12 Months|"Kaplan-Meier estimate of proportion of patients that had not experienced acute rejection by 12 months. Acute rejection is defined as rejection at any of the following grades.
Grade A0 - None With/Without Grade A1 - Minimal Grade A2 - Mild Grade A3 - Moderate"|12 mos|The analysis population included patients who underwent at least one transbronchial biopsy.||percentage of participants|||Number
721761|NCT00321906|Primary|Acute Rejection Rate at 12 Months|Raw proportion of patients that experienced acute rejection at or before 12 months.|12mos|||percentage of participants|||Number
721762|NCT00321919|Secondary|Number of Participants With Marked Laboratory Abnormalities|Marked abnormality of laboratory parameters is defined as the value which is outside the defined reference range of that respective parameter. Values above and below the given reference range were determined as High or Low range values of the laboratory parameter. Roche’s standard reference ranges for laboratory test parameters were used for the analysis. The laboratory parameters with marked abnormality are platelets (reference range is 150-350 10^9 cells/liter [L]), creatinine (reference range is 0-133 micromole per liter), albumin (reference range is 35.0-55 g/L), phosphate (reference range is 0.84-1.45 millimole per liter [mmol /L]) and potassium (reference range is 3.4-4.8 mmol /L).|Baseline, every 3 months up to 4 years|The safety analysis population included all participants who were randomized and who had received a safety follow-up whether or not they had received epoetin beta treatment. The ‘’n” represents the number of participants assessed for each laboratory parameter.||participants|||Number
721763|NCT00321919|Secondary|Number of Participants on Blood Pressure/Anti-Hypertensive Treatment According to Class Of Drugs|Anti-hypertensive is defined as class of drugs that are used to treat hypertension. Numbers (No.) of participants treated with at least one hypertensive medication/Treatment (Tt) according to class of drugs were reported.|Up to 4 years|The safety analysis population included all participants who were randomized and who had received a safety follow-up whether or not they had received epoetin beta treatment.||participants|||Number
721764|NCT00321919|Secondary|Mean Change From Baseline in the Scores of Each of The Eight Health Scales of Quality of Life Based on Short Form-36 (SF-36) Questionnaire|The Quality of life was assessed on the basis of a change from baseline in the scores of each of the eight health scales in the SF-36 questionnaire. The SF-36 is a standardized survey evaluating 8 domains (consisting of 2 components; physical and mental) of functional health and well-being: physical and social functioning, physical and emotional role (role-physical, role-emotional) limitations, bodily pain, general health (GH), vitality, mental health. The score for a section is an average of the individual question scores, which are scaled from 0 (worst level of functioning) to 100 (100=best level of functioning). The least squares mean (LSM) change from baseline was determined by Analysis of covariance (ANCOVA) model and presented for each of the eight health scale.|Baseline, Year 1, and Year 2|The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received.||units on a scale||Standard Error|Least Squares Mean
721765|NCT00321919|Secondary|Mean Values of Body Surface Area|The body surface area (BSA) was determined by Echocardiogram. Absolute mean values of Echocardiography (ECHO) Parameter: Body surface area (BSA) at Baseline, Year 1, Year 2, Year 3 and Year 4 were calculated and presented.|Baseline, Year 1, Year 2, Year 3, and Year 4.|The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received. The “n” represents the number of participants assessed for Body surface area through echocardiogram at Baseline, Year 1, Year 2, Year 3 and Year 4.||Square meter||Standard Deviation|Mean
721766|NCT00321919|Secondary|Mean Values of Echocardiography Parameters|Mean values of Echocardiography (ECHO) Parameters: Left Ventricular End Diastolic Diameter (LVEDD), Left Ventricular Posterior Wall Thickness (LVPWT), IV Septal Wall Thickness (IVSWT), LV End Systolic Diameter (LVESD), LV Relative wall thickness (LVRWT) at Baseline, Year 1, Year 2, Year 3 and Year 4 were presented.|Baseline, Year 1, Year 2, Year 3, and Year 4|The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received. The “n” represents the number of participants assessed for each echocardiography parameter at Baseline, Year 1, Year 2, Year 3 and Year 4.||centimeters||Standard Deviation|Mean
721768|NCT00321919|Secondary|Mean Change From Baseline in Left Ventricular Ejection Fraction (LVEF) and Fractional Myocardial Shortening (FS)|LVEF is a marker of left ventricular systolic function and determined by echocardiogram. It is expressed as the ratio of left ventricular stroke volume (LVSV) to left ventricular end-diastolic volume (LVEDV), and is measured as a percentage. FS is used as an estimate of myocardial contractility and determined by echocardiogram and measures as a percentage. The change for LVEF and FS was calculated as Week value minus baseline value.|Baseline, Week 12, Week 24, Week 36, and Week 48|The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received. The “n” represents the number of participants assessed for LVEF and FS at Baseline, Week 12, Week 24, Week 36, and Week 48.||percentage||Standard Deviation|Mean
721769|NCT00321919|Secondary|Mean Change From Baseline in Left Ventricular Mass Index (LVMI)|LVMI is determined by echocardiogram. LVMI indexed to body surface area (gram/square meter) estimated by LV cavity dimension and wall thickness at end-diastole. The change was calculated as week value minus baseline value.|Baseline, Week 12, Week 24, Week 36, and Week 48|The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received. The “n” represents the number of participants assessed for LVMI at Baseline, Week 12, Week 24, Week 36, and Week 48.||gram/square meter||Standard Deviation|Mean
721770|NCT00321919|Secondary|Duration of Hospitalization for Cardiovascular Events|The duration of hospitalization was the total number of days that a participant was hospitalized due to cardiovascular events. Participants with no hospitalization were excluded from analysis.|Up to 4 years|The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received. Data for the participants present at the time of assessment was used for analysis.||days||Standard Deviation|Mean
721771|NCT00321919|Secondary|Median Time to First Hospitalization Due to Cardiovascular Events|Time to first hospitalization due to cardiovascular events is defined as the time determined between randomization and first hospitalization due to cardiovascular events.|Up to 4 years|The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received.||days||Inter-Quartile Range|Median
721772|NCT00321919|Secondary|Total Number of Cardiovascular Intervention|Cardiovascular intervention was defined by a clinical review of all concomitant treatments. The cardiovascular interventions considered were: angioplasty with or without stents/atherectomy, coronary artery bypass surgery, cardioverter defibrillator (CD) cardioversion/defibrillation, temporary pacemaker, permanent pacemaker and implantable cardioverter defibrillator (ICD) implantation. The total number of cardiovascular intervention was determined and presented by each cohort.|Up to 4 years|The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received.||number of cardiovascular intervention|||Number
721773|NCT00321919|Secondary|Median Time to First Cardiovascular Intervention|Time to first cardiovascular intervention is the time between randomization and first intervention determined for all cardiovascular interventions after randomization. Cardiovascular interventions considered were: angioplasty with or without stents/atherectomy, coronary artery bypass surgery, cardioverter defibrillator (CD) cardioversion/defibrillation, temporary pacemaker, permanent pacemaker and implantable cardioverter defibrillator (ICD) implantation.|Up to 4 years|The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received.||days||Inter-Quartile Range|Median
721774|NCT00321919|Secondary|Number of Participants Experiencing Worsening of New York Heart Association (NYHA) Class (CL) of Chronic Heart Failure From Baseline (BL)|The NYHA functional classification assesses the severity of symptoms of chronic heart failure and is comprised of four classes. Class I is defined as no limitation of physical activity, Class II is defined as slight limitation of physical activity, Class III is defined as marked limitation of physical activity, and Class IV is defined as unable to carry on any physical activity without discomfort. Shifts of participants from CL 0, CL I, CL II, CL III, CL IV at Baseline (Day 1) to CL 0, CL I, CL II, CL III, CL IV during the study period was determined and presented.|Up to 4 years|The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received. The “n” represents the number of participants assessed for shifts in NYHA class from baseline.||participants|||Number
721775|NCT00321919|Secondary|Number of Participants Who Died Due to All Causes|Number of participants who died due to all causes are presented in table below.|Up to 4 years|The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received.||participants|||Number
721776|NCT00321919|Secondary|Median Time to Death Due to All Causes|Time to death due to all causes is the time determined between randomization and death due to all causes.|Up to 4 years|The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received.||days||Inter-Quartile Range|Median
721777|NCT00321919|Secondary|Number of Participants Who Died Due to Cardiovascular Events|The cardiovascular event was defined as any of the following: angina pectoris leading to hospitalization for at least 24 hours or prolongation of hospitalization, acute heart failure, fatal or non-fatal myocardial infarction, fatal or non-fatal stroke, sudden death, transient cerebral ischemic attack (TIA), peripheral vascular disease (amputation, necrosis), cardiac arrhythmias leading to hospitalization for at least 24 hours or prolongation of hospitalization.|Up to 4 years|The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received.||participants|||Number
721778|NCT00321919|Secondary|Median Time to Death Due to Cardiovascular Events|Time to death due to cardiovascular events is the time determined between randomization and death due to cardiovascular events.|Up to 4 years|The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received.||days||Inter-Quartile Range|Median
721793|NCT00322049|Secondary|Proportion of Subjects With a Dengue Viremia 10 Days Post Booster Dose|"Proportion of subjects with a dengue viremia 10 days after each dose of vaccine.
RT PCR = Reverse-transcriptase polymerase chain reaction Nested PCR - Nested polymerase chain reaction"|10 days after post dose 1 and 2|Proportion of subjects is illustrated as presented in Final Clinical Study Report. Results were not listed by arm/cohort.||% of subjects|||Number
721779|NCT00321919|Primary|Median Time to First Cardiovascular Event|The cardiovascular event was defined as any of the following: angina pectoris leading to hospitalization for at least 24 hours or prolongation of hospitalization, acute heart failure, fatal or non-fatal myocardial infarction, fatal or non-fatal stroke, sudden death, transient cerebral ischemic attack (TIA), peripheral vascular disease (amputation, necrosis), cardiac arrhythmias leading to hospitalization for at least 24 hours or prolongation of hospitalization. The time to occurrence of a cardiovascular event was determined as the time from randomization until any of the above listed events whichever occurred first. The first event per participant was used for the analysis. Only events confirmed by the Endpoint Committee were considered for analysis.|Up to 4 years|The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received.||days||Inter-Quartile Range|Median
721780|NCT00321932|Secondary|Mean Change in Total Testosterone|Change in bone resorption markers of bone metabolism measured at baseline and 12 months post transplant for all enrolled patients. Testosterone affects the brain, bone and muscle mass, fat distribution, the vascular system, energy levels, genital tissues, and sexual functioning.|From Time of Transplant to 12 Months Post-Transplant|||ng/dL||Standard Deviation|Mean
721781|NCT00321932|Secondary|Mean Change in Ultrasensitive Estradiol|Change in bone resorption markers of bone metabolism measured at baseline and 12 months post transplant for all enrolled patients. In women estradiol is responsible for growth of the breast and reproductive epithelia, maturation of long bones and development of the secondary sexual characteristics.|From Time of Transplant to 12 Months Post-Transplant|||pg/ml||Standard Deviation|Mean
721782|NCT00321932|Secondary|Mean Change in Thyroid Function Test 4|Change in bone resorption markers of bone metabolism measured at baseline and 12 months post transplant for all enrolled patients. Individuals who have hyperthyroidism will have an elevated thyroxine (FT4). Low serum thyroxine can also indicate a pituitary problem.|From Time of Transplant to 12 Months Post-Transplant|||ng/dL||Standard Deviation|Mean
721783|NCT00321932|Secondary|Mean Change in Follicle-Stimulating Hormone|Change in bone resorption markers of bone metabolism measured at baseline and 12 months post transplant for all enrolled patients. Follicle-stimulating hormone is a hormone produced by the anterior pituitary gland.|From Time of Transplant to 12 Months Post-Transplant|||IU/L||Standard Deviation|Mean
721784|NCT00321932|Secondary|Mean Change in Luteinizing Hormone|Change in bone resorption markers of bone metabolism measured at baseline and 12 months post transplant for all enrolled patients. Luteinizing hormone is a hormone produced by the anterior pituitary gland.|From Time of Transplant to 12 Months Post-Transplant|||IU/L||Standard Deviation|Mean
721785|NCT00321932|Secondary|Mean Change in Urinary N-terminal Telopeptide|Change in bone resorption markers of bone metabolism measured at baseline and 12 months post transplant for all enrolled patients. In bone physiology, the N-terminal telopeptide is a biomarker used to measure the rate of bone turnover.|From Time of Transplant to 12 Months Post-Transplant|||nM Bone Collagen Equivalents/mM creatini||Standard Deviation|Mean
721786|NCT00321932|Secondary|Mean Change in Serum Bone Specific Alkaline Phosphate|Change in bone resorption markers of bone metabolism measured at baseline and 12 months post transplant for all enrolled patients. The decrease in serum bone-specific alkaline phosphatase predicts bone mineral density response to hormone replacement therapy in early postmenopausal women.|From Time of Transplant to 12 Months Post-Transplant|||U/L||Standard Deviation|Mean
721787|NCT00321932|Secondary|Mean Change in Serum Osteocalcin|Change in bone resorption markers of bone metabolism measured at baseline and 12 months post transplant for all enrolled patients. As osteocalcin is produced by osteoblasts, it is often used as a marker for the bone formation process.|From Time of Transplant to 12 Months Post-Transplant|||ng/ml||Standard Deviation|Mean
721788|NCT00321932|Primary|Mean Change in Bone Mineral Density|"Change in bone mineral density of the femoral neck measured from baseline to 12 months after transplant utilizing Dual-energy X-ray absorptiometry (DEXA) scan. Comparison of difference between the standard of care group (receiving calcium and vitamin D)and the Zometa group. The measurement consists of baseline bone mineral density measurements with followup measurements at 12 months.
This will be analyzed as a continuous variable. Percent change in bone mineral density (BMD) will be calculated as (BMD change) x 100/BMD baseline."|From Time of Transplant to 12 Months Post-Transplant|||percent||Standard Deviation|Mean
721789|NCT00321984|Secondary|Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean|The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.|4 weeks|Analysis was conducted on an ITT population (all randomized subjects who received at least 1 dose of study drug and completed at least 1 diary entry for heartburn during treatment), but excluded subjects without any morning diary entries on Day 1 or later.||percentage of days||Standard Deviation|Mean
721790|NCT00321984|Secondary|Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median|The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.|4 weeks|Analysis was conducted on an ITT population (all randomized subjects who received at least 1 dose of study drug and completed at least 1 diary entry for heartburn during treatment), but excluded subjects without any morning diary entries on Day 1 or later.||percentage of days||Inter-Quartile Range|Median
721791|NCT00321984|Primary|Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean|The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked.|4 weeks|Analysis was conducted on an intent-to-treat (ITT) population that included all randomized subjects who received at least 1 dose of study drug and completed at least 1 diary entry for heartburn during treatment. All ITT populations excluded subjects with confirmed Barrett’s esophagus and/or definite dysplastic changes.||percentage of days||Standard Deviation|Mean
721792|NCT00321984|Primary|Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median|The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked.|4 weeks|Analysis was conducted on an intent-to-treat (ITT) population that included all randomized subjects who received at least 1 dose of study drug and completed at least 1 diary entry for heartburn during treatment. All ITT populations excluded subjects with confirmed Barrett’s esophagus and/or definite dysplastic changes.||percentage of days||Inter-Quartile Range|Median
721795|NCT00322049|Primary|JE Vaccine Response|Seropositivity rates and GMTs for N lg to JEV antibodies. Pre= Pre vaccination, blood sampling prior to the first vaccine dose; PI(M1)= Post 1, month 1, blood sampling one month after dose 1 at study month 1; PI(M6)= Post 1, month 6, blood sampling 6 months after dose 1 at study month 6; PII(M7)= Post II, month 7, blood sampling one month after dose 2 at study month 7; PIV(M8.5)= Post IV, month 8.5, blood sampling after 2 doses of dengue/control and 2 doses of JE vaccines at study month 8.5|Pre-vaccination, 1, 6, 7 and 8.5 months after two doses of dengue vaccine|||% of subjects with titer within range||95% Confidence Interval|Mean
721796|NCT00322049|Primary|Seronegative Neutralizing (N) Antibody Titers to Each DEN Serotype After Dengue Dose 2 (and 2 Doses of JE)|"Seropositivity for N antibody against DEN 1, 2, 3 and 4 antibody after dengue dose 2 (and 2 doses of JE).
Seronegative (antibody titer <10 1/Dil for N lg to DEN-1, N lg to DEN-2, N lg to DEN-3, N lg) prior to vaccination."|month 8.5|||% of responders||95% Confidence Interval|Mean
721797|NCT00322049|Primary|Seronegative Neutralizing (N) Antibody Titers to Each DEN Serotype After Dose 2|"Seronegative for N antibody against DEN 1, 2, 3 and 4 antibody after dengue dose 2.
Seronegative (antibody titer <10 1/Dil for N lg to DEN-1, N lg to DEN-2, N lg to DEN-3, N lg) prior to vaccination."|month 7 after dose 2|||% of responders||95% Confidence Interval|Mean
721798|NCT00322049|Primary|Geometric Mean Titers (GMT) for N Antibody to All Four Serotypes and Japanese Encephalitis (JE) Vaccine|Assess the immunogenicity of the dengue vaccine in terms of GMTs 30 days post-Dose 2 of dengue vaccine for all four serotypes (DEN-1, 2, 3, 4 and JE (Japanese encephalitis)). Analysis of immunogenicity was performed on the ATP cohort.|30 days post Dose 2|GMT calculated on all subjects. Dil = Dilution; P1(M1) = blood sampling on month after dose 1, at study month 1; PII(M7) = blood sampling one month after dose 2, at study month 7; PII(M8.5) = blood sampling 2 1/2 months after dose 2, at study month 8.5||titers||95% Confidence Interval|Mean
721799|NCT00322049|Primary|Reactogenicity in Terms of Solicited Symptoms After Dose 1 of the Dengue Vaccine vs. Control Vaccine.|Local and general solicited reactogenicity using diary cards for 21 days (days 0-20) after the first dose of dengue/control vaccine|21-day follow-up period after Dose 1|Format of results is consistent with how data was presented in the Final Clinical Study Report. Combining of cohorts B and C was due to both cohorts being full dose||specified events|||Number
721800|NCT00322101|Secondary|Incidence and Severity of Acute and Chronic Graft-vs-host Disease||After transplantation|||participants|||Number
721801|NCT00322101|Secondary|Incidence of Disease Progression/Relapse|Disease progression/relapse was defined by IWG criteria|After stem cell infusion to date of last follow up.|||participants|||Number
721802|NCT00322101|Secondary|Donor Cell Engraftment|Chimerism analysis was performed in patients who recieved nonmyeloablative tranplsnat. In this group the definition of engraftment was a CD3 count greater than 50%. In the myeloablative group, engraftment was defined as an absolute neutrophil count greater than 50%.|After stem cell infusion to day 28|2 patients who were randomized to receive nonmyeloablative conditioning did not undergo transplant due to relapse and withdrawal of consent||participants|||Number
721803|NCT00322101|Secondary|Non-relapse Mortality||At 100 days|2 patients in the nonmyeloablative arm did not receive transplant due to relapse and withdrawal of consent||participants|||Number
721804|NCT00322101|Secondary|Progression-free Survival|IWG criteria was used to determine disease progression|After stem cell infusion to date of last follow up.|2 patients in the nonmyeloablative arm did not receive a transplant due to relapse and withdrawal of consent||participants|||Number
721805|NCT00322101|Primary|Overall Survival||At 2 years|2 patients in the nonmyeloablative arm did not receive transplant due to relapse and withdrawal of consent||participants|||Number
721806|NCT00322153|Secondary|Change From Baseline in the 19-Item Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL19) Scale at Week 24 (LOCF)|The ADCS-ADL19 modified inventory consists of 19 items used to measure the functional capabilities of patients with moderate to severe dementia. Each activity-of-daily-living (ADL) item comprises a series of hierarchical subquestions ranging from the highest level of independent performance to complete loss of ability to perform the ADL Inventory. The inventory is performed by interviewing a person in close contact with the patient and covers the most usual and consistent performance of the patient over the preceding 4 weeks. Response range is 0 (total disability) to 54 (total independence).|Baseline to week 24|The secondary efficacy analysis was based on the ITT Population. The last-observation-carried-forward approach was used to impute missing post-Baseline values.||Units on a scale||Standard Error|Least Squares Mean
721807|NCT00322153|Primary|Clinician’s Interview-Based Impression of Change With Caregiver Input (CIBIC-plus) at Week 24 (LOCF)|The CIBIC-Plus is a measure of an overall clinical effect and is based on a comprehensive evaluation at Baseline and later visits of four domains: general (overall clinical status), functional (including activities of daily living), cognitive, and behavioral. A skilled clinician interviews the patient, and includes information supplied by a knowledgeable caregiver. The CIBIC-Plus is a rating of the patient’s global status relative to Baseline, ranging from a score of 1, indicating “marked improvement” to a score of 4, indicating “no change” to a score of 7, indicating “marked worsening.”|Week 24|Primary efficacy analysis was based on the Intent-to-Treat (ITT) Population. The ITT Population was consisted of all patients in the Safety Population who completed at least one post-Baseline efficacy assessment in SIB or CIBIC-Plus. The last-observation-carried-forward approach was used to impute missing post-Baseline values.||Units on a scale||Standard Error|Mean
721808|NCT00322153|Primary|Change From Baseline in Severe Impairment Battery (SIB) at Week 24 (LOCF)|The SIB was developed for the evaluation of cognitive function in patients with more advanced dementia, and evaluates the areas of memory, language, praxis, orientation, and attention. The SIB test items consist of simple, one-step commands presented with gestural cues that are repeated if necessary. The test contains 51 items, and the range of possible scores is 0 to 100 (with 0 being the worst result). The SIB has been shown to be a valid and reliable instrument sensitive to longitudinal change.|Baseline to week 24|Primary efficacy analysis was based on the Intent-to-Treat (ITT) Population. The ITT Population was consisted of all patients in the Safety Population who completed at least one post-Baseline efficacy assessment in SIB or CIBIC-Plus. The last-observation-carried-forward approach was used to impute missing post-Baseline values.||Units on a scale||Standard Error|Least Squares Mean
721809|NCT00322231|Secondary|Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers From Prevaccination to 4 Weeks Postvaccination|GMFR of the VZV antibody response at the prespecified day ranges prevaccination and 4 weeks postvaccination|From prevaccination (baseline) to 4 weeks postvaccination|Per-protocol population||Geometric mean fold rise||95% Confidence Interval|Number
721811|NCT00322231|Primary|Vaccine-related Serious Adverse Experiences (SAEs) for 28 Days Postvaccination|SAEs are AEs at any dose that: Results in death or persistent/significant disability/incapacity; or prolongs an existing inpatient hospitalization or Is life threatening; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose or Is an other important medical event|To Day 28 postvaccination|All vaccinated participants were evaluated for safety. This was a crossover study. All participants received one dose each of ZOSTAVAX™ and placebo. Data below reflect SAEs reported after receipt of ZOSTAVAX™ or placebo.||Participants|||Number
721812|NCT00322309|Secondary|Percent Urines Positive for Riboflavin|This measure of adherence was determined by finding the percent of total urines examined that were positive for riboflavin, which had been added to each medication tablet.|Weeks 1-11|||Percentage of total urines examined||Standard Deviation|Mean
721813|NCT00322309|Secondary|Pill Count|Percentage of medication capsules administered based on the ratio of the number of capsules administered to the total number dispensed for entire period during which subjects were in treatment.|Weeks 1 to 11|||Percentage of dispensed capsules||Standard Deviation|Mean
721814|NCT00322309|Secondary|Hamilton Depression Rating Scale|Subjects are assessed on 24 characteristics of depressive disorders. Scale scores may range from 0 for no depressive symptoms to 75.|Week 11|||Scores on a scale||Standard Deviation|Mean
721815|NCT00322309|Secondary|The Clinical Global Impression Observer (CGI-O)Comparison for Week 11|Clinician's overall assessment of the subjects global functioning including the severity of the subject's cocaine use, cocaine seeking, use of other drugs, psychiatric symptoms, medical problems, maladaptive family/social coping, and coping with issues related to employment, housing, and legal issues. Totals range between 7 (for none) to 56 for most severe.|Week 11|Data was analyzed fof all subjects for whom data from the second evaluation visit was available||Scores on a scale||Standard Deviation|Mean
721816|NCT00322309|Primary|Ln Benzoylecgonine Concentration||Week 11|Data was analyzed for all subjects who provided data for the second assessment visit.||ln (ng/ml)||Standard Deviation|Mean
721817|NCT00322335|Primary|Number of Subjects With Serious Adverse Events|Serious adverse events assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From last study contact of the booster study (NCT00323050) to Month 66 after booster dose (day 0)|Analysis was performed on the Total Cohort, which included all vaccinated subjects in the booster study (NC00323050) and who came back during the follow-up.||subjects|||Number
721818|NCT00322335|Primary|Anti-PSC Concentrations|Concentrations for anti-PSC antibody were expressed as GMCs.|18, 30, 42, 54 and 66 months after the booster dose (day 0)|Analysis was performed on the According-to-Protocol Cohort for antibody persistence, which included all subjects with evaluable data at each timepoint and who participated in the primary study (NCT00352963) and booster study (NCT00323050).||µg/mL (microgram per milliliter)||95% Confidence Interval|Geometric Mean
721819|NCT00322335|Primary|Number of Subjects With Anti-polysaccharide C (Anti-PSC) Concentrations Equal to or Above Cut-off Value of 2.0 µg/mL (Microgram Per Milliliter)|"The cut-off value was an anti-PSC concentration equal to or above 2.0 µg/mL (microgram per milliliter).
0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section."|18, 30, 42, 54 and 66 months after the booster dose (day 0)|Analysis was performed on the According-to-Protocol Cohort for antibody persistence, which included all subjects with evaluable data at each timepoint and who participated in the primary study (NCT00352963) and booster study (NCT00323050).||subjects|||Number
721820|NCT00322335|Primary|Number of Subjects With Anti-polysaccharide C (Anti-PSC) Concentrations Equal to or Above Cut-off Value of 0.3 µg/mL (Microgram Per Milliliter)|"The cut-off value was an anti-PSC concentration equal to or above 0.3 µg/mL (microgram per milliliter).
0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section."|18, 30, 42, 54 and 66 months after the booster dose (day 0)|Analysis was performed on the According-to-Protocol Cohort for antibody persistence, which included all subjects with evaluable data at each timepoint and who participated in the primary study (NCT00352963) and booster study (NCT00323050).||subjects|||Number
721821|NCT00322335|Primary|Anti-PRP Concentrations|Concentrations are expressed as Geometric Mean Concentrations (GMCs) in µg/mL (microgram per milliliter).|18, 30, 42, 54 and 66 months after the booster dose (day 0)|Analysis was performed on the According-to-Protocol Cohort for antibody persistence, which included all subjects with evaluable data at each timepoint and who participated in the primary study (NCT00352963) and booster study (NCT00323050).||µg/mL (microgram per milliliter)||95% Confidence Interval|Geometric Mean
721822|NCT00322335|Primary|Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Concentrations Equal to or Above Cut-off Value of 1.0 µg/mL (Microgram Per Milliliter)|The cut-off value was an anti-PRP concentration equal to or above 1.0 µg/mL (microgram per milliliter).|18, 30, 42, 54 and 66 months after the booster dose (day 0)|Analysis was performed on the According-to-Protocol Cohort for antibody persistence, which included all subjects with evaluable data at each timepoint and who participated in the primary study (NCT00352963) and booster study (NCT00323050).||subjects|||Number
721823|NCT00322335|Primary|Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Concentrations Equal to or Above Cut-off Value of 0.15 µg/mL (Microgram Per Milliliter)|The cut-off value was an anti-PRP concentration equal to or above 0.15 µg/mL (microgram per milliliter).|18, 30, 42, 54 and 66 months after the booster dose (day 0)|Analysis was performed on the According-to-Protocol Cohort for antibody persistence, which included all subjects with evaluable data at each timepoint and who participated in the primary study (NCT00352963) and booster study (NCT00323050).||subjects|||Number
721824|NCT00322335|Primary|rSBA-MenC Titers|"Titers are expressed as Geometric Mean Titers (GMTs).
0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section."|18, 30, 42, 54 and 66 months after booster dose (day 0)|Analysis was performed on the According-to-Protocol Cohort for antibody persistence, which included all subjects with evaluable data at each timepoint and who participated in the primary study (NCT00352963) and booster study (NCT00323050).||titer||95% Confidence Interval|Geometric Mean
722156|NCT00307684|Secondary|Change From DB Baseline to DB Endpoint in CAARS Self Rated Scale (CAARS-S:S) Total Score|Evaluation of treatment effects as rated by the subjects on the CAARS-S:S. best score: 0 worst score: 104|DB baseline, DB endpoint|||units on a scale||Standard Deviation|Mean
721825|NCT00322335|Primary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:128|"The cut-off value for the rSBA-MenC titers was equal to or above 1:128.
0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section."|18, 30, 42, 54 and 66 months after booster dose (day 0)|Analysis was performed on the According-to-Protocol Cohort for antibody persistence, which included all subjects with evaluable data at each timepoint and who participated in the primary study (NCT00352963) and booster study (NCT00323050).||subjects|||Number
721826|NCT00322335|Primary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:32|"The cut-off value for the rSBA-MenC titers was equal to or above 1:32.
0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section."|18, 30, 42, 54 and 66 months after booster dose (day 0)|Analysis was performed on the According-to-Protocol Cohort for antibody persistence, which included all subjects with evaluable data at each timepoint and who participated in the primary study (NCT00352963) and booster study (NCT00323050).||subjects|||Number
721827|NCT00322335|Primary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:8|"The cut-off value for the rSBA-MenC titers was equal to or above 1:8.
0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section."|18, 30, 42, 54 and 66 months after booster dose (day 0)|Analysis was performed on the According-to-Protocol Cohort for antibody persistence, which included all subjects with evaluable data at each timepoint and who participated in the primary study (NCT00352963) and booster study (NCT00323050).||subjects|||Number
721828|NCT00322348|Secondary|Area Under the Plasma Concentration Curve (0-12 Weeks)|Area under the plasma concentration curve (0-12 weeks) derived from analysis of pharmacokinetic (PK) outcomes samples provided only by participants in the PK subgroup set (all of whom received ZOLADEX 10.8 mg)|Blood samples taken at Days 1, 2 and 3, Weeks 4, 12 and 24. Derived from the individual goserelin plasma concentration-time profiles following the first dose of study drug for patients in the pharmacokinetic (PK) subgroup|participants in the PK subgroup set||ng/mL||Full Range|Geometric Mean
721829|NCT00322348|Secondary|Time to Maximum Plasma Concentration, Tmax (Hours)|Time to maximum plasma concentration, Tmax (hours), derived from analysis of pharmacokinetic (PK) outcomes samples provided only by participants in the PK subgroup set (all of whom received ZOLADEX 10.8 mg)|Blood samples taken at Days 1, 2 and 3, Weeks 4, 12 and 24. Derived from the individual goserelin plasma concentration-time profiles following the first dose of study drug for patients in the pharmacokinetic (PK) subgroup|participants in the PK subgroup set||hours||Full Range|Geometric Mean
721830|NCT00322348|Secondary|Maximum Plasma Concentration, Cmax (ng/mL)|Maximum plasma concentration, Cmax (ng/mL), derived from analysis of pharmacokinetic (PK) outcomes samples provided only by participants in the PK subgroup set (all of whom received ZOLADEX 10.8 mg)|Blood samples taken at Days 1, 2 and 3, Weeks 4, 12 and 24. Derived from the individual goserelin plasma concentration-time profiles following the first dose of study drug for patients in the pharmacokinetic (PK) subgroup|participants in the pharmacokinetic (PK) subgroup||ng/mL||Full Range|Geometric Mean
721831|NCT00322348|Secondary|Oestradiol (E2) Serum Concentrations at Week 24|A comparison of mean E2 serum concentrations at timepoint(s) post Day 1 performed using analysis of covariance (ANCOVA), with treatment group, baseline E2 serum concentrations and country as covariates. Data analysed on the log scale; log scale mean and pooled log scale standard deviation from Analysis of Covariance (ANCOVA) presented.|Blood samples for measurement of E2 concentrations collected from all patients at scheduled visits of screening, Day 1 and Weeks 12 and 24 (+/- 7 days). Week 24 data is presented|||pmol/L||Standard Deviation|Log Mean
721832|NCT00322348|Secondary|Objective Response Rate (ORR) at Week 24|Number of participants who were objective responders at Week 24 over the number of participants evaluable for response x 100. An objective responder = a participants whose best unconfirmed response is either CR (Complete Response Disappearance of all target lesions) or PR (Partial Response At least a 30% decrease in target lesions)|Response Evaluation Criteria in Solid Tumours (RECIST) tumour assessments carried out every 12 weeks from randomisation until Week 24 in those patients with measurable disease at baseline.|||Percentage of participants|||Number
721833|NCT00322348|Primary|Percentage of Participants With Progression Free Survival (PFS) at Week 24|The number of participants for whom neither objective disease progression or death (due to any cause) has been observed at Week 24 over the number of randomised participants x 100.|Objective tumour assessments carried out every 12 weeks (+/- 7 days) until Week 24, and then every 24 weeks (+/- 14 days) until Week 96 or objective progression is confirmed according to Response Evaluation Criteria in Solid Tumours (RECIST).|||Percentage of participants|||Number
721834|NCT00322374|Secondary|Number Of Participants With Tumor Response by Duration of Response Category|Duration of response was defined as the interval measured from the time that the measurement criteria are first met for CR or PR, whichever occurs first, until the date of documented progressive disease or death; PR= ≥30% decrease in the sum of the longest diameter of target lesions.|Time (in months) when criteria for CR or PR are met (which ever occurs first) up to date of progressive disease.|Participants with measurable disease who received any treatment, as well as response evaluable participants. Evaluations were based on tumor measurements collected on the case report form using RECIST incorporating the use of target/non-target lesions.||participants|||Number
721835|NCT00322374|Secondary|Duration of Tumor Response|Defined as the interval measured from the time that the measurement criteria are first met for CR or PR, whichever occurs first, until the date of documented progressive disease or death. CR= disappearance of all target lesions; PR= ≥30% decrease in the sum of the longest diameter of target lesions.|Time (in months) when criteria for CR or PR are met (which ever occurs first) up to date of progressive disease.|Participants with measurable disease who received any treatment, as well as response evaluable participants. Evaluations were based on tumor measurements collected on the case report form using RECIST incorporating the use of target/non-target lesions.||months||Full Range|Median
722227|NCT00307931|Secondary|C-reactive Protein Level at Each of Weeks 1, 2, 4, 6, 8, 12 and 14||Weeks 1, 2, 4, 6, 8, 12 and 14|Due to the low number of subjects recruited only an abbreviated report was produced with limited analyses. This outcome measure was not included in the limited analyses.||mg/L||Standard Deviation|Mean
721836|NCT00322374|Secondary|Number Of Participants With A Best Overall Tumor Response of Complete Response, Partial Response, Stable Disease, And Progressive Disease|Information on all tumor lesions was obtained at baseline by radiologic techniques, or if appropriate by physical examination (e.g. subcutaneous nodules). Measurable tumors were evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) criteria, wherein complete response (CR) = disappearance of all target lesions; partial response (PR) = ≥30% decrease in the sum of the longest diameter of target lesions; progressive disease (PD)= ≥20% increase in the sum of the longest diameter of target lesions, and stable disease (SD) = small changes that do not meet above criteria.|From Baseline (up to 2 weeks prior to starting therapy) to the end Cycle 2|Participants with measurable disease who received any treatment, as well as response evaluable participants. Evaluations were based on tumor measurements collected on the case report form using RECIST incorporating the use of target/non-target lesions.||participants|||Number
721837|NCT00322374|Secondary|Epirubicin Vss|PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. Vss= Volume of distribution at steady-state of epirubicin administered IV 75 mg/m^2, derived from plasma concentration versus time data.|From the start of the ixabepilone infusion on Day 1 to 24 hours after the first infusion.|Participants who had received any treatment with ixabepilone and epirubicin and had adequate concentration profiles.||liters||Standard Deviation|Mean
721838|NCT00322374|Secondary|Epirubicin CLT|PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. CLT= Total body clearance from plasma of epirubicin administered IV 75 mg/m^2, derived from plasma concentration versus time data.|From the start of the ixabepilone infusion on Day 1 to 24 hours after the first infusion.|Participants who had received any treatment with ixabepilone and epirubicin and had adequate concentration profiles.||L/h||Standard Deviation|Mean
721839|NCT00322374|Secondary|Epirubicin T-Half|PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. T-Half=terminal-phase elimination half-life in plasma of epirubicin administered IV dose 75 mg/m^2, derived from plasma concentration versus time data.|From the start of the ixabepilone infusion on Day 1 to 24 hours after the first infusion.|Participants who had received any treatment with ixabepilone and epirubicin and had adequate concentration profiles.||hours||Standard Deviation|Mean
721840|NCT00322374|Secondary|Epirubicin AUC(INF)|PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. AUC(INF)=the area under the plasma concentration-time curve from time zero extrapolated to infinity of epirubicin administered IV 75 mg/m^2, derived from plasma concentration versus time data.|From the start of the ixabepilone infusion on Day 1 to 24 hours after the first infusion.|Participants who had received any treatment with ixabepilone and epirubicin and had adequate concentration profiles.||ng·h/mL||Standard Deviation|Mean
721841|NCT00322374|Secondary|Epirubicin Cmax|PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. Cmax=maximum observed plasma concentration of epirubicin administered IV 75 mg/m^2, derived from plasma concentration versus time data.|From the start of the ixabepilone infusion on Day 1 to 24 hours after the first infusion.|Participants who had received any treatment with ixabepilone and epirubicin and had adequate concentration profiles.||ng/ml||Standard Deviation|Mean
721842|NCT00322374|Secondary|Volume of Distribution at Steady State (Vss) of Single-dose Ixabepilone|PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. Vss= Volume of distribution at steady-state of single-dose ixabepilone administered with IV dose of epirubicin 75 mg/m^2, derived from plasma concentration versus time data.|From the start of the ixabepilone infusion on Day 1 to 120 hours after the first infusion.|Participants who had received any treatment with ixabepilone and epirubicin and had adequate concentration profiles.||liters||Standard Deviation|Mean
721843|NCT00322374|Secondary|Clearance (CLT) of Single-dose Ixabepilone|PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. CLT= Total body clearance from plasma of single-dose ixabepilone administered with IV dose of epirubicin 75 mg/m^2, derived from plasma concentration versus time data.|From the start of the ixabepilone infusion on Day 1 to 120 hours after the first infusion.|Participants who had received any treatment with ixabepilone and epirubicin and had adequate concentration profiles.||L/h||Standard Deviation|Mean
721844|NCT00322374|Secondary|Terminal Half-life (T-Half) of Single-dose Ixabepilone|PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. T-Half=terminal-phase elimination half-life in plasma of single-dose ixabepilone administered with IV dose of epirubicin 75 mg/m^2, derived from plasma concentration versus time data.|From the start of the ixabepilone infusion on Day 1 to 120 hours after the first infusion.|Participants who had received any treatment with ixabepilone and epirubicin and had adequate concentration profiles.||hours||Standard Deviation|Mean
721845|NCT00322374|Secondary|Area Under the Curve, Extrapolated to Infinity (AUC[INF]) of Single-dose Ixabepilone|PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. AUC(INF)=area under the plasma concentration-time curve from time zero extrapolated to infinite time of single-dose ixabepilone administered with IV dose of epirubicin 75 mg/m^2.|From the start of the ixabepilone infusion on Day 1 to 120 hours after the first infusion.|Participants who had received any treatment with ixabepilone and epirubicin and had adequate concentration profiles.||ng·h/mL||Standard Deviation|Mean
721846|NCT00322374|Secondary|Maximum Plasma Concentration (Cmax) of Single-dose Ixabepilone|Pharmacokinetics (PK) is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. Cmax=maximum observed plasma concentration of single-dose ixabepilone administered with IV dose of epirubicin 75 mg/m^2, derived from plasma concentration versus time data.|From the start of the ixabepilone infusion on Day 1 to 120 hours after the first infusion.|Participants who had received any treatment with ixabepilone and epirubicin and had adequate concentration profiles.||ng/ml||Standard Deviation|Mean
721910|NCT00322556|Primary|The Proportion of Infusions With One or More Temporally-associated Adverse Events (AEs).|AEs were considered temporally-associated AEs if they occurred during the infusion or in the period from the start of the infusion until either 48 or 72 hours after the end of the infusion.|During each infusion, and within 48 or 72 hours after the end of each infusion.|The Safety Data Set (SDS) comprised all subjects treated with the study drug.||Proportion of infusions|Participants||Number
721847|NCT00322374|Secondary|Number of Participants With Death, Adverse Events (AEs), Serious Adverse Events (SAEs), Grade 3/4 AEs, or AEs Leading to Discontinuation|AEs and SAEs considered possibly, probably, or certainly related to study treatment, graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death).SAE= any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization/prolongation of existing hospitalization, results in persistent/significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event|Evaluated continuously on study from Baseline to ≤30 days after the last dose of study drug.|All participants who received at least 1 cycle of therapy were evaluable for safety; adverse events and other symptoms were graded according to CTCAE Version 3.0.||participants|||Number
721848|NCT00322374|Primary|Ixabepilone Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (R2PD)|The MTD was the highest dose in which 0/6 or 1/6 participants experienced DLT with at least 2 out of no more than 6 participants experiencing DLT at the next higher dose level. The RP2D was based on the MTD and the assessment of any relevant chronic toxicity. To obtain further confidence in the RP2D, a total maximum of 30 evaluable participants were enrolled at the MTD.|Day 21 of Cycle 1|The evaluable participant population consisted of participants who met the minimum safety evaluation requirements of the study: participant received ≥1 dose of ixabepilone and epirubicin in Cycle 1, completed adequate safety evaluations, and were observed for ≥21 days following the first dose or the participant experienced DLT.||mg^m2|||Number
721849|NCT00322374|Primary|Number of Participants With a Dose Limiting Toxicity (DLT)|DLT: any of the following considered related to ixabepilone, epirubicin or combination occurring in Cycle 1: Absolute neutrophil count <500 cells/mm^3 for ≥7 consecutive days or febrile neutropenia of any duration;Grade(Gr)4 thrombocytopenia <25,000 cells/mm^3 or Gr3 w/bleeding requiring platelet transfusion;Any other drug-related Gr3/4 non-hematologic toxicity except Gr3 injection site reaction, fatigue, transient arthralgia/myalgia;Delayed recovery to Gr≤1 or baseline (except for alopecia) from toxicity related to treatment w/ ixabepilone + epirubicin delaying initiation of next cycle ≥3 wks|From Baseline to the end of Cycle 1 (Day 21)|The evaluable participant population consisted of participants who met the minimum safety evaluation requirements of the study: participant received ≥1 dose of ixabepilone and epirubicin in Cycle 1, completed adequate safety evaluations, and was observed for ≥21 days following the first dose or the participant experienced DLT.||Participants|||Number
721850|NCT00322387|Secondary|Number of Transplants in Which Participants Achieved Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant|Participants were monitored for polymorphonuclear leukocyte (PMN) engraftment as per the local standard of care. The target for engraftment was 12 days after PBSC transplant and no transplant taking longer than 21 days for engraftment.|2 months|Intent to treat population. Six participants with MM had 2 transplants.||transplants|Participants||Number
721851|NCT00322387|Secondary|Fold (i.e., Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL|The fold increase was measured by fluorescence activated cell sorting (FACS) analysis and was expressed as a ratio. Fold increase = (pre-apheresis PB CD34+ cells/µL)/(pre-plerixafor dosing PB CD34+ cells/µL).|Days 4-5 (first dose of plerixafor to apheresis)|Intent to treat population. One participant in the Non-Hodgkin's Lymphoma (NHL): Plerixafor AM treatment group and 3 participants in the Multiple Myeloma (MM): Plerixafor After Chemo treatment group did not have samples taken for PB CD34+ cell counts on Day 1 and therefore could not be included.||ratio||Standard Deviation|Mean
721852|NCT00322387|Primary|Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant|Safety assessment was based on the incidence of adverse event reports. Participant count of AEs (Adverse Events) by severity and by relationship to study drug. AEs were reported regardless of relationship to study treatment. The investigator graded each AE using the World Health Organization (WHO) Adverse Event Grading Scale and provided assessments of seriousness and relatedness to study treatment.|13 months|Safety population who received at least one dose of plerixafor.||participants|||Number
721853|NCT00322439|Secondary|Percentage of Body Surface Area Affected by Psoriasis|Body Surface Area (BSA) is a numerical score used to measure the physician’s assessment of the percentage of the participant’s total BSA involved with psoriasis.|Baseline, Year 3 and Year 5|Participants who received at least one registry dose of etanercept, excluding participants who were enrolled at sites that were closed for cause, and with available data at each time point (indicated by n).||percentage of body surface area||Standard Error|Mean
721854|NCT00322439|Secondary|Work Productivity and Activity Impairment (WPAI)|The WPAI questionnaire has six questions to assess whether the participant was currently employed (Q1); how many hours from work were missed due to problems associated with psoriasis (Q2) or any other reason (Q3); hours actually worked (Q4); degree that psoriasis affected productivity while working (Q5); and degree that psoriasis affected regular activities (Q6) over the past 7 days. Four separate overall scores were calculated, including absenteeism (work time missed due to health), presenteeism (impairment at work due to health), work productivity loss (overall work impairment due to health), and activity impairment due to health. Each score ranges from 0 to 100 with higher scores indicating greater impairment and less productivity (ie, worse outcomes).|Baseline, Year 3 and Year 5|Participants who received at least one registry dose of etanercept, excluding participants who were enrolled at sites that were closed for cause, and with available data at each time point (indicated by n), and who were employed (for the first 3 scores).||units on a scale||Standard Error|Mean
721855|NCT00322439|Secondary|Healthcare Resource Use|"This self-administered questionnaire is designed to measure the amount of healthcare resource utilization by the participant in the past 4 weeks. The average answers to the following questions are reported:
How many times have you been to any physician’s office or urgent care clinic, not including your dermatologist?
How many times have you seen a nurse practitioner, physician assistant, psychologist, naturopath, acupuncturist, or chiropractor?
How many times have you received care from a health professional (HP) in your home?
How many times have you paid someone to help you do chores around the house (cleaning, maintenance, lawn care)?
How many times have you had a friend or family member take time off work to provide care or transportation?"|Baseline, Year 3 and Year 5|Participants who received at least one registry dose of etanercept, excluding participants who were enrolled at sites that were closed for cause, and with available data at each time point (indicated by n).||times||Standard Error|Mean
721856|NCT00322439|Secondary|Euroqol-5D (EQ-5D) Visual Analog Scale (VAS)|The EQ-5D visual analog scale (VAS) is a 100 mm scale with 100 representing 'best imaginable health state' and 0 representing 'worst imaginable health state'. Participants were asked to indicate on this scale how good or bad their health was today.|Baseline, Year 3 and Year 5|Participants who received at least one registry dose of etanercept, excluding participants who were enrolled at sites that were closed for cause, and with available data at each time point (indicated by n).||units on a scale||Standard Error|Mean
721857|NCT00322439|Secondary|Euroqol-5D (EQ-5D) Total Score|EQ-5D is a self-reported questionnaire that consists of five single-item health domains, mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The answers are recorded as choices of 1, 2, or 3 for each question, with 1 signifying no problem, 2 signifying some problem, and 3 signifying major problem. Using the US scoring algorithm, the possible total EQ-5D score ranges from -0.11 (ie, answered ‘3’ for all questions) to 1.0 (ie, answered ‘1’ for all questions), where 1.0 represents perfect health.|Baseline, Year 3 and Year 5|Participants who received at least one registry dose of etanercept, excluding participants who were enrolled at sites that were closed for cause, and with available data at each time point (indicated by n).||units on a scale||Standard Error|Mean
721858|NCT00322439|Secondary|Percentage of Participants With a Dermatology Life Quality Index (DLQI) Response|The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. A DLQI response is defined as a 5 point improvement from Baseline or a score of 0.|Baseline, Year 3 and Year 5|Participants who received at least one registry dose of etanercept, excluding participants who were enrolled at sites that were closed for cause, and with available data at each time point (indicated by n).||percentage of participants|||Number
721859|NCT00322439|Secondary|Percentage of Participants With a Patient's Global Assessment of Psoriasis Score of 0 or 1|The patient's global assessment of psoriasis is a self-administered numeric scale is designed to evaluate participants' perception of their psoriasis on a scale from 0 (good) to 5 (severe).|Baseline and at 3 and 5 years|Participants who received at least one registry dose of etanercept, excluding participants who were enrolled at sites that were closed for cause, and with available data at each time point (indicated by n).||percentage of participants|||Number
721860|NCT00322439|Secondary|Percentage of Participants With a Static Physician’s Global Assessment (sPGA) of Psoriasis Score of 0 (Clear) or 1 (Almost Clear)|The sPGA scale is designed to evaluate the physician’s global assessment of the participant’s psoriasis based on severity of induration, scaling, and erythema. The sPGA is assessed on a scale of 0 to 5 (0 = clear, 5 = severe).|Baseline and at 3 and 5 years|Participants who received at least one registry dose of etanercept, excluding participants who were enrolled at sites that were closed for cause, and with available data at each time point (indicated by n).||percentage of participants|||Number
721861|NCT00322439|Secondary|Five-year Cumulative Incidence for Events of Medical Interest (EMIs)|Protocol defined EMIs included: • All malignancies, including basal cell carcinoma (BCC) and squamous cell carcinoma (SCC); • Tuberculosis; • Opportunistic infections treated with intravenous therapy; • Histoplasmosis infections treated with oral antibiotics; • Coccidioidomycosis infections treated with oral antibiotics; • Central nervous system (CNS) demyelinating disorders; • Lupus disease; • Coronary artery disease; • Worsening of psoriasis as defined by change in psoriasis morphology and withdrawal of therapy; • Any event or laboratory abnormality that represents an event of medical significance. Cumulative incidences were calculated using Kaplan-Meier methods where time to event was defined as the time from the first dose of etanercept to the start date of the first occurrence of the event, regardless of exposure (ie, based on observation time). Estimates were adjusted using left truncation methodology to help address any bias due to participants with prior etanercept exposure.|5 years|Full analysis set||proportion of participants||95% Confidence Interval|Number
721862|NCT00322439|Primary|Five-year Cumulative Incidence of Serious Adverse Events and Serious Infectious Events|A serious adverse event (SAE), including a serious infectious event (SIE), is defined as one that suggests a significant hazard or side effect, regardless of the investigator or sponsor’s opinion on the relationship to a drug product. This includes, but may not be limited to, any event that (at any dose) is fatal, life threatening, requires inpatient hospitalization that includes a minimum of an overnight stay or prolongation of existing hospitalization, is a persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. Cumulative incidences were calculated using Kaplan-Meier methodology for all participants who received at least 1 registry dose of etanercept. For SAEs and SIEs, time to event was re-defined from calendar time to cumulative time up to the event, excluding time intervals and events when the participant was not on etanercept treatment (ie, based on etenercept exposure time).|5 years|||proportion of participants||95% Confidence Interval|Number
721863|NCT00322452|Secondary|Symptom Improvement as Measured by the Lung Cancer Subscale (LCS) of the FACT-L Questionnaire|Number of patients improving: a patient was described as improved if they had 2 visits (at least 21 days apart) where there was an increase in LCS score (from baseline) of 2 or more, and there were no intervening visits showing a decrease from baseline of 2 or more. Includes all patients with QoL data at baseline & at least 1 post-baseline visit|FACT-L data were collected at baseline, week 1, every 3 weeks (from baseline) until day 127, then every 42 days until the patient was confirmed as having objectively progressed (via RECIST), and at treatment discontinuation.|Analysis was carried out on the Evaluable-for-QoL (EFQ) population. The EFQ population is a subset of the ITT population containing patients with an evaluable baseline QoL assessment and at least 1 evaluable post-baseline QoL assessment.||Participants|||Number
721864|NCT00322452|Secondary|Quality of Life (QoL) as Measured by the Trial Outcome Index (TOI) of the Functional Assessment of Cancer Therapy - Lung Cancer (FACT-L) Questionnaire|Number of patients improving: a patient was described as improved if they had 2 visits (at least 21 days apart) where there was an increase in TOI score (from baseline) of 6 or more, and there were no intervening visits showing a decrease from baseline of 6 or more. Includes all patients with QoL data at baseline & at least 1 post-baseline visit|FACT-L data were collected at baseline, week 1, every 3 weeks (from baseline) until day 127, then every 42 days until the patient was confirmed as having objectively progressed (via RECIST), and at treatment discontinuation.|Analysis was carried out on the Evaluable-for-QoL (EFQ) population. The EFQ population is a subset of the ITT population containing patients with an evaluable baseline QoL assessment and at least 1 evaluable post-baseline QoL assessment.||Participants|||Number
721865|NCT00322452|Secondary|Quality of Life (QoL) as Measured by the Total Score of the Functional Assessment of Cancer Therapy - Lung Cancer (FACT-L) Questionnaire|Number of patients improving: a patient was described as improved if they had 2 visits (at least 21 days apart) where there was an increase in FACT-L score (from baseline) of 6 or more, and there were no intervening visits showing a decrease from baseline of 6 or more. Includes all patients with QoL data at baseline & at least 1 post-baseline visit|FACT-L data were collected at baseline, week 1, every 3 weeks (from baseline) until day 127, then every 42 days until the patient was confirmed as having objectively progressed (via RECIST), and at treatment discontinuation.|Analysis was carried out on the Evaluable-for-QoL (EFQ) population. The EFQ population is a subset of the ITT population containing patients with an evaluable baseline QoL assessment and at least 1 evaluable post-baseline QoL assessment.||Participants|||Number
721866|NCT00322452|Secondary|Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Liver Transaminases|Number of patients with an elevated liver transaminase event, identified from the lab data as a worsening in ALT or AST from baseline to a CTC grade 3 or above. Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).|Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel|Analysis was carried out on the Evaluable-for-safety (EFS) population. The EFS population is a subset of the ITT population which includes all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).||Participants|||Number
721867|NCT00322452|Secondary|Vomiting|Number of patients with a vomiting event. Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel)|Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel|Analysis was carried out on the Evaluable-for-safety (EFS) population. The EFS population is a subset of the ITT population which includes all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).||Participants|||Number
721868|NCT00322452|Secondary|Nausea|Number of patients with a nausea event. Based on the evaluable for-safety-population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel)|Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel|Analysis was carried out on the Evaluable-for-safety (EFS) population. The EFS population is a subset of the ITT population which includes all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).||Participants|||Number
721869|NCT00322452|Secondary|Diarrhoea|Number of patients with a diarrhoea event. Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel)|Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel|Analysis was carried out on the Evaluable-for-safety (EFS) population. The EFS population is a subset of the ITT population which includes all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).||Participants|||Number
721870|NCT00322452|Secondary|Rashes/Acnes|Number of patients with a rashes/acnes event. Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel)|Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel|Analysis was carried out on the Evaluable-for-safety (EFS) population. The EFS population is a subset of the ITT population which includes all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).||Participants|||Number
721871|NCT00322452|Secondary|Neurotoxicity|Number of patients with a neurotoxicity event. Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel)|Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel|Analysis was carried out on the Evaluable-for-safety (EFS) population. The EFS population is a subset of the ITT population which includes all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).||Participants|||Number
721872|NCT00322452|Secondary|Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Anaemia|Number of patients with an anaemia event, identified from the lab data as a worsening in haemoglobin from baseline to a CTC grade 3 or above. Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).|Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel|Analysis was carried out on the Evaluable-for-safety (EFS) population. The EFS population is a subset of the ITT population which includes all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).||Participants|||Number
721873|NCT00322452|Secondary|Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Leukopenia|Number of patients with a leukopenia event, identified from the lab data as a worsening in white blood cell count from baseline to a CTC grade 3 or above. Based on the evaluable for-safety-population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).|Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel|Analysis was carried out on the Evaluable-for-safety (EFS) population. The EFS population is a subset of the ITT population which includes all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).||Participants|||Number
721874|NCT00322452|Secondary|Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Thrombocytopenia|Number of patients with a thromboctyopenia event, identified from the lab data as a worsening in platelet count from baseline to a CTC grade 3 or above. Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).|Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel|Analysis was carried out on the Evaluable-for-safety (EFS) population. The EFS population is a subset of the ITT population which includes all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).||Participants|||Number
721875|NCT00322452|Secondary|Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Neutropenia|Number of patients with a neutropenia event, identified from the lab data as a worsening in absolute neutrophil count from baseline to a CTC grade 3 or above which Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).|Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel|Analysis was carried out on the Evaluable-for-safety (EFS) population. The EFS population is a subset of the ITT population which includes all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).||Participants|||Number
721876|NCT00322452|Secondary|Objective Tumour Response Rate According to RECIST|Number of participants with an objective response. An objective response (OR) was defined as a patient having a best overall response of either complete response (CR) or partial response (PR) according to RECIST, confirmed at least 28 days following the date of the initial response.|Tumour assessments as per RECIST were performed at baseline and then every 42 days ± 7 days from randomization until data cut off (14th April 2008).|Analysis was carried out on Intention-to-treat (ITT) population.||Participants|||Number
721877|NCT00322452|Secondary|Median Overall Survival (OS) in Months at OS Data Cut Off (14th June 2010)|Overall Survival was assessed via calculation of the time to death due to any cause. If a participant was known to have died, the time to death was defined as the time from the date of randomization to the date of death. Otherwise, a participant was censored at the last date they were known to be alive. Median Overall Survival in months is presented here.|Following the PFS DCO on 14th April 2008 information on survival status was collected every 8 weeks.|Analysis was carried out on Intention-to-treat (ITT) population.||Months||95% Confidence Interval|Median
721878|NCT00322452|Primary|Median Progression Free Survival (PFS) in Months|PFS was defined as the interval from the date of randomization to the date of objective disease progression (as per RECIST) or the date of death (from any cause) in the absence of objective disease progression. The median PFS in months is presented here.|Tumour assessments as per RECIST were performed at baseline and then every 42 days ± 7 days from randomization until data cut off (14th April 2008).|Analysis was carried out on Intention-to-treat (ITT) population.||Months||95% Confidence Interval|Median
721896|NCT00322491|Other Pre-specified|Number of Participants With Durable Engraftment 12 Months After Transplantation|The number of participants maintaining a durable graft 12 months after autologous transplantation. A durable graft is defined as the maintenance of normal blood counts.|Approximately 13 months (12 months post-transplant )|Participants who received plerixafor, underwent transplantation, and were evaluable 12 months post transplant. The one participant who did not have a durable graft at 12 months had received chemotherapy for relapse approximately 9 months after transplantation.||participants|||Number
721911|NCT00322621|Secondary|Change From Baseline (Week 0) in Vital Signs: Weight at Week 34 Endpoint||Baseline (Week 0), Week 34|All patients who received either 60 mg or 120 mg duloxetine once daily.||kilograms (kg)||Standard Deviation|Mean
721897|NCT00322491|Other Pre-specified|Number of Transplants in Which Participants Achieved Platelet (PLT) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant|Participants were monitored for platelet (PLT) engraftment as per the local standard of care. The target for engraftment was 12 days after PBSC transplant and no transplant taking longer than 21 days for engraftment.|2 months|A total of 47 participants were transplanted. Two participants in the MM group received a second transplant using cells collected on study. One participant in the MM group did not have PLT engraftment information recorded, however did report a durable graft at month 12 post transplant.||number of transplants|Participants||Number
721898|NCT00322491|Secondary|Number of Transplants in Which Participants Achieved Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant|Participants were monitored for polymorphonuclear leukocyte (PMN) engraftment as per the local standard of care. The target for engraftment was 12 days after PBSC transplant and no transplant taking longer than 21 days for engraftment.|2 months|Participants who received a transplant. Two participants in the MM group received a second transplant.||number of transplants|Participants||Number
721899|NCT00322491|Other Pre-specified|Median Cumulative Number of CD34+ Cells Collected During Apheresis|Median cumulative total number of CD34+ cells collected during apheresis.|Days 5-8|Participants who received at least one dose of plerixafor||CD34+ cells (*10^6 / kg)||Full Range|Median
721900|NCT00322491|Secondary|Number of Participants Achieving a Two-Fold (Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL Following the First Dose of Plerixafor|The number of participants mobilized with G-CSF + plerixafor injection who have a ≥ 2-fold increase in CD34+ cells. Fold increase was expressed as a ratio. Fold increase = (pre-apheresis PB CD34+ cells/µL) / (pre-plerixafor dosing PB CD34+ cells/µL)|Days 4-5 (first dose of plerixafor to apheresis)|The intent-to-treat population (defined as participants who received at least 1 dose of plerixafor).||participants|||Number
721901|NCT00322491|Primary|Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE)|Number of participants with treatment emergent adverse events (TEAEs) collected from Day 1 (start of G-CSF mobilization) to the day before starting chemotherapy (approximately day 38). AEs were graded by the investigator using the World Health Organization (WHO) Adverse Event Grading Scale and were assessed for severity (mild, moderate, severe) and relatedness to study treatment (5 point scale from 'not related' to 'definitely related').|Day 1 to approximately Day 38 (before start of chemotherapy)|Safety population – all participants who received at least 1 dose of plerixafor.||participants|||Number
721902|NCT00322556|Primary|Number of Subjects With Clinically Significant Changes in Vital Signs.|Vital signs included heart rate, systolic blood pressure, diastolic blood pressure, and body temperature.|Before, during, and after each infusion.|The Safety Data Set (SDS) comprised all subjects treated with the study drug.||Participants|||Number
721903|NCT00322556|Secondary|Trough Levels of Total Immunoglobulin (IgG) Serum Concentrations.|Mean IgG trough concentration. For this analysis, each subject’s values were first aggregated to their median and the median values were then analyzed.|Prior to each infusion; every 3 or 4 weeks depending upon the dosing schedule.|The ITT data set comprised all subjects treated with the study drug for which serum IgG information was available.||g/L||Full Range|Mean
721904|NCT00322556|Secondary|Annualized Rate of Any Infection.|"The annualized rate was based on the total number of infections and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.
Infections were classified as all AEs with the system organ class “infections and infestations” and AEs with the preferred term “conjunctivitis”."|For the duration of the study, up to approximately 29 months.|The ITT data set comprised all subjects treated with the study drug.||Infections per subject year|Participants||Number
721905|NCT00322556|Secondary|Number of Days of Hospitalization.||For the duration of the study, up to approximately 29 months|The ITT data set comprised all subjects treated with the study drug. The patient diary (in which the number of days was recorded) was not available for 1 subject so the analyzed population was reduced from 55 to 54 subjects for this outcome measure.||Days||Full Range|Median
721906|NCT00322556|Secondary|Number of Days Out of Work / School / Kindergarten / Day Care or Inability to Perform Normal Activities Due to Illness.||For the duration of the study, up to approximately 29 months.|The ITT data set comprised all subjects treated with the study drug. The patient diary (in which the number of days was recorded) was not available for 1 subject so the analyzed population was reduced from 55 to 54 subjects for this outcome measure.||Days||Full Range|Median
721907|NCT00322556|Secondary|Annualized Rate of Acute Serious Bacterial Infections.|"The annualized rate was based on the total number of infections and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.
Acute serious bacterial infections included pneumonia, bacteremia / septicemia, osteomyelitis / septic arthritis, bacterial meningitis, and visceral abscess."|For the duration of the study, up to approximately 29 months|The Intention-To-Treat (ITT) data set comprised all subjects treated with the study drug||Infections per subject year|Participants||Number
721908|NCT00322556|Primary|Rate of AEs by Severity and Relationship|"The AE rate was the number of AEs over the number of infusions administered.
Mild AEs: Did not interfere with daily activities; Moderate AEs: Interfered with routine daily activities; Severe AEs: Impossible to perform routine daily activities.
At least possibly related AEs included possibly related AEs, probably related AEs, and related AEs."|For the duration of the study, up to approximately 29 months|The SDS comprised all subjects treated with the study drug.||AEs per infusion|Participants||Number
721909|NCT00322556|Primary|Influence of Infusion Rate on Temporally-Associated AEs|"The total and most frequent (1% or more) number of infusions for which subjects experienced temporally-associated AEs occurring within 72 hours of infusion, by infusion rate (≤ 4 mg/kg/min, ≤ 8 mg/kg/min, and > 8 and ≤ 12 mg/kg/min).
AEs were considered to be temporally-associated AEs if they occurred in the period from the start of the infusion until 72 hours after the end of the infusion."|Within 72 hours after each infusion|'New subjects’ could receive IgPro10 at up to 4 mg/kg/min. 'Old' subjects (ie, those treated with the study drug who participated in a preceding, pivotal, Phase III clinical study with intravenous IgPro10 [study number ZLB03_002CR, NCT00168025]), could receive IgPro10 at up to 12 mg/kg/min at the discretion of the Investigator.||Infusions|Participants||Number
721912|NCT00322621|Secondary|Change From Baseline (Week 0) in Vital Signs: Systolic Blood Pressure at Week 34 Endpoint||Baseline (Week 0), Week 34|All patients who received either 60 mg or 120 mg duloxetine once daily.||mm Hg||Standard Deviation|Mean
721917|NCT00322621|Secondary|Rescue Arm: Change From Baseline (Week 8) in Beck Depression Inventory-II (BDI-II) Total Score at Week 34 Endpoint|A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.|Baseline (Week 8), Week 34|Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.||units on a scale||Standard Deviation|Mean
721918|NCT00322621|Secondary|Maintenance Arm: Change From Baseline (Week 8) in Beck Depression Inventory-II (BDI-II) Total Score at Week 34 Endpoint|A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.|Baseline (Week 8), Week 34|Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.||units on a scale||Standard Deviation|Mean
721919|NCT00322621|Secondary|Rescue Arm: Change From Baseline (Week 8) in Sensory Portion of the Short-Form McGill Pain Questionnaire at Week 34 Endpoint|This instrument consists of 11 pain descriptors. The sensory pain portion scores range from 0 (none) to 3 (severe).|Baseline (Week 8), Week 34|Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.||units on a scale||Standard Deviation|Mean
721920|NCT00322621|Secondary|Maintenance Arm: Change From Baseline (Week 8) in Sensory Portion of the Short-Form McGill Pain Questionnaire at Week 34 Endpoint|This instrument consists of 11 pain descriptors. The sensory pain portion scores range from 0 (none) to 3 (severe).|Baseline (Week 8), Week 34|Number of responders with a baseline and ate least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.||units on a scale||Standard Deviation|Mean
721921|NCT00322621|Secondary|Rescue Arm: Change From Baseline (Week 8) in Clinical Global Impressions of Severity (CGI-S) at Week 34 Endpoint|Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Baseline (Week 8), Week 34|Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.||units on a scale||Standard Deviation|Mean
721922|NCT00322621|Secondary|Maintenance Arm: Change From Baseline (Week 8) in Clinical Global Impressions of Severity (CGI-S) at Week 34 Endpoint|Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Baseline (Week 8), Week 34|Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.||units on a scale||Standard Deviation|Mean
721923|NCT00322621|Secondary|Rescue Arm: Patient's Global Impressions of Improvement (PGI-I) at Week 34 Endpoint|A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).|Week 34|Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.||units on a scale||Standard Deviation|Mean
721924|NCT00322621|Secondary|Maintenance Arm: Patient’s Global Impressions of Improvement (PGI-I) at Week 34 Endpoint|A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).|Week 34|Number of responders with at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.||units on a scale||Standard Deviation|Mean
721925|NCT00322621|Secondary|Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Average Interference at Week 34 Endpoint|A self-reported scale that measures interference of pain on average of the 7 questions assessing the interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The average Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline (Week 8), Week 34|Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.||units on a scale||Standard Deviation|Mean
721926|NCT00322621|Secondary|Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Average Interference at Week 34 Endpoint|A self-reported scale that measures interference of pain on average of the 7 questions assessing the interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The average Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline (Week 8), Week 34|Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.||units on a scale||Standard Deviation|Mean
721927|NCT00322621|Secondary|Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Enjoyment of Life at Week 34 Endpoint|A self-reported scale that measures the interference of pain in the past 24 hours on enjoyment of life. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline (Week 8), Week 34|Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.||units on a scale||Standard Deviation|Mean
721928|NCT00322621|Secondary|Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Enjoyment of Life at Week 34 Endpoint|A self-reported scale that measures the interference of pain in the past 24 hours on enjoyment of life. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline (Week 8), Week 34|Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.||units on a scale||Standard Deviation|Mean
721929|NCT00322621|Secondary|Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Sleep at Week 34 Endpoint|A self-reported scale that measures the interference of pain in the past 24 hours on sleep. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline (Week 8), Week 34|Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.||units on a scale||Standard Deviation|Mean
721930|NCT00322621|Secondary|Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Sleep at Week 34 Endpoint|A self-reported scale that measures the interference of pain in the past 24 hours on sleep. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline (Week 8), Week 34|Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.||units on a scale||Standard Deviation|Mean
721931|NCT00322621|Secondary|Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Relations With Other People at Week 34 Endpoint|A self-reported scale that measures the interference of pain in the past 24 hours on relations with other people. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline (Week 8), Week 34|Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.||units on a scale||Standard Deviation|Mean
721932|NCT00322621|Secondary|Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Relations With Other People at Week 34 Endpoint|A self-reported scale that measures the interference of pain in the past 24 hours on relations with other people. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline (Week 8), Week 34|Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.||units on a scale||Standard Deviation|Mean
721933|NCT00322621|Secondary|Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Normal Work at Week 34 Endpoint|A self-reported scale that measures the interference of pain in the past 24 hours on normal work. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline (Week 8), Week 34|Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.||units on a scale||Standard Deviation|Mean
721934|NCT00322621|Secondary|Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Normal Work at Week 34 Endpoint|A self-reported scale that measures the interference of pain in the past 24 hours on normal work. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline (Week 8), Week 34|Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.||units on a scale||Standard Deviation|Mean
721935|NCT00322621|Secondary|Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Walking Ability at 34 Week Endpoint|A self-reported scale that measures the interference of pain in the past 24 hours on walking ability. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline (Week 8), Week 34|Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.||units on a scale||Standard Deviation|Mean
721936|NCT00322621|Secondary|Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Walking Ability at Week 34 Endpoint|A self-reported scale that measures the interference of pain in the past 24 hours on walking ability. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline (Week 8), Week 34|Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.||units on a scale||Standard Deviation|Mean
721937|NCT00322621|Secondary|Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Mood at Week 34 Endpoint|A self-reported scale that measures the interference of pain in the past 24 hours on mood. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline (Week 8), Week 34|Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.||units on a scale||Standard Deviation|Mean
721938|NCT00322621|Secondary|Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Mood at Week 34 Endpoint|A self-reported scale that measures the interference of pain in the past 24 hours on mood. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline (Week 8), Week 34|Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.||units on a scale||Standard Deviation|Mean
721939|NCT00322621|Secondary|Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: General Activity at Week 34 Endpoint|A self-reported scale that measures the interference of pain in the past 24 hours on general activity. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline (Week 8), Week 34|Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.||units on a scale||Standard Deviation|Mean
721940|NCT00322621|Secondary|Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: General Activity at Week 34 Endpoint|A self-reported scale that measures the interference of pain in the past 24 hours on general activity. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline (Week 8), Week 34|Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.||units on a scale||Standard Deviation|Mean
722030|NCT00323492|Primary|Change From Baseline to Week 12 in Fasting Triglycerides|Centralized laboratory assessment. Change = Week 12 value minus baseline value.|Baseline to Week 12|ITT. Last post-baseline observation carried forward (LOCF) method was used for the analysis if the Week 12 value was missing. A missing datum were replaced by the last post-baseline value.||mmol/L||Inter-Quartile Range|Median
721941|NCT00322621|Secondary|Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Pain Right Now Score at Week 34 Endpoint|A self-reported scale that measures the severity of pain based on the pain right now. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline (Week 8), Week 34|Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.||units on a scale||Standard Deviation|Mean
721942|NCT00322621|Secondary|Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Pain Right Now Score at Week 34 Endpoint|A self-reported scale that measures the severity of pain based on the pain right now. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline (Week 8), Week 34|Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.||units on a scale||Standard Deviation|Mean
721943|NCT00322621|Secondary|Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Average Pain Score at 34 Week Endpoint|A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline (Week 8), Week 34|Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.||units on a scale||Standard Deviation|Mean
721944|NCT00322621|Secondary|Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Average Pain Score at Week 34 Endpoint|A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline (Week 8), Week 34|Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.||units on a scale||Standard Deviation|Mean
721945|NCT00322621|Secondary|Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Least Pain Score at Week 34 Endpoint|A self-reported scale that measures the severity of pain based on the least pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline (Week 8), Week 34|Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.||units on a scale||Standard Deviation|Mean
721946|NCT00322621|Secondary|Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Least Pain Score at Week 34 Endpoint|A self-reported scale that measures the severity of pain based on the least pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline (Week 8), Week 34|Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.||units on a scale||Standard Deviation|Mean
721947|NCT00322621|Secondary|Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Worst Pain Score at Week 34 Endpoint|A self-reported scale that measures the severity of pain based on the worst pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline (Week 8), Week 34|Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.||units on a scale||Standard Deviation|Mean
721948|NCT00322621|Secondary|Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Worst Pain Score at Week 34 Endpoint|A self-reported scale that measures the severity of pain based on the worst pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline (Week 8), Week 34|Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.||units on a scale||Standard Deviation|Mean
721949|NCT00322621|Secondary|Rescue Arm: Number of Patients With a ≥50% Reduction From Baseline (Week 0) in Brief Pain Inventory 24-hour Average Pain Item|A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline (Week 0), Week 34|Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.||participants|||Number
721950|NCT00322621|Secondary|Maintenance Arm: Number of Patients With a ≥50% Reduction From Baseline (Week 0) in Brief Pain Inventory 24-hour Average Pain Item|A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline (Week 0), Week 34|Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.||participants|||Number
721951|NCT00322621|Primary|Change From Baseline (Week 8) in Brief Pain Inventory (BPI) 24-hour Average Pain Item Score at Week 34 Endpoint|Maintenance effect of duloxetine 60 mg in patients with diabetic peripheral neuropathic pain (DPNP) was assessed by the change in BPI 24-hour average pain item score from baseline of the maintenance therapy arm (week 8) to 34 week endpoint in patients who achieved at least a 30 percent reduction on the BPI 24-hour average pain item after 8 weeks of acute therapy (Acute Therapy Phase). BPI is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline (Week 8), Week 34|Patients entering maintenance phase on duloxetine 60 mg QD. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.||units on a scale||Standard Deviation|Mean
721952|NCT00322712|Primary|Time to Death|Length of survival of patients treated with a combination of Oxaliplatin 60mg/m2, Irinotecan 90mg/m2, and Cetuximab 250 mg/m2 delivered every other week.|From date of treatment until time of death|||Months||Full Range|Median
721953|NCT00322777|Secondary|Remission|Remission of depression was assessed at the four time points (baseline, 8 weeks, 16 weeks and 24 weeks) using the Hamilton Depression Rating Scale (HAM-D). Remission was based on a HAM-D score of less than 7. Remission is indicated as a percentage of participants at each time point whose scores were below 7.|baseline, 8 weeks, 16 weeks, and 24 weeks|||percentage of participants score < 7|||Number
721954|NCT00322777|Secondary|Response Rate|Response rate was assessed at the four time points (baseline, 8 weeks, 16 weeks and 24 weeks) using the Hamilton Depression Rating Scale (HAM-D). A response was determined as a reduction in the HAM-D score by at least 50% from the baseline score. The data are presented as the percentage of participants with response at each time point as compared to baseline.|baseline, 8 weeks, 16 weeks, and 24 weeks|||percentage of participants with response|||Number
721955|NCT00322777|Primary|Hamilton Depression Rating Scale - Depression Severity|"Depression severity was assessed at the four time points (baseline, 8 weeks, 16 weeks and 24 weeks) using the Hamilton Depression Rating Scale (HAM-D). The HAM-D is a standardized outcome measure of depression severity in adults. Total scores includes the sum of 17-items, with eight items scored on a range of 0 (absent) to 2 (marked or definite) and nine scored on a range of 0 (absent) to 4 (very severe). The level of depression was based on the following scoring ranges: 7 or under not depressed, 8-13 some depressive symptoms but no depressive disorder, 12-15 mild depression, 16-19 moderate depression, 20-24 moderately severe depression, and 25+ severe depression.
The HAM-D was administered through a face to face interview, which was conducted by a trained nurse who was blinded to participants’ allocation."|baseline, 8 weeks, 16 weeks, and 24 weeks|||units on a scale||Full Range|Mean
721956|NCT00322842|Secondary|Increase in Peripheral Blood (PB) CD34+ Cells From Steady-state Hematopoiesis to Pre-leukapheresis in G-CSF+Plerixafor Treated Participants Compared to Historical Controls Treated With G-CSF Alone or Chemotherapy and G-CSF|A comparison of the effectiveness in mobilizing peripheral blood CD34+ cells between this study's treatment regimen (G-CSF plus plerixafor) to other treatment options: G-CSF alone, and chemotherapy with G-CSF.|up to day 8|Analysis was not performed. Historical data was not available.|||||
721957|NCT00322842|Other Pre-specified|Number of Participants With Durable Engraftment 12 Months After Transplantation|The number of participants maintaining a durable graft 12 months after autologous transplantation. A durable graft is defined as the maintenance of normal blood counts.|Approximately 13 months (12 months post-transplant )|Participants who had transplants and engraftment data 12 months after transplantation||participants|||Number
721958|NCT00322842|Other Pre-specified|Number of Transplants in Which Participants Achieved Platelet (PLT) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant|Participants were monitored for platelet (PLT) engraftment as per the local standard of care. The target for engraftment was 12 days after PBSC transplant and no transplant taking longer than 21 days for engraftment.|2 months|Participants who had transplants. Fifteen participants had tandem transplants.||number of transplants|Participants||Number
721959|NCT00322842|Secondary|Number of Transplants in Which Participants Achieved Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant|Participants were monitored for polymorphonuclear leukocyte (PMN) engraftment as per the local standard of care. The target for engraftment was 12 days after PBSC transplant and no transplant taking longer than 21 days for engraftment.|2 months|Participants who had transplants. Fifteen participants had tandem transplants. The date of initial PMN engraftment was missing for 11 transplants, which were later shown to have durable grafts.||number of transplants|Participants||Number
721960|NCT00322842|Other Pre-specified|Median Cumulative Number of CD34+ Cells Collected During Apheresis|Median total number of CD34+ cells collected during apheresis as measured by a central lab.|Days 5-8|Intent to treat population. Samples from two participants were not analyzed by the central lab.||CD34+ cells (*10^6 / kg)||Full Range|Median
721961|NCT00322842|Secondary|Fold (i.e., Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL After First Dose of Plerixafor|The fold increase was measured using local lab values and is the ratio of post first dose (pre-apheresis) PB CD34+ cells/µL)/pre-plerixafor dosing PB CD34+ cells/µL)|Days 4-5 (first dose of plerixafor to apheresis)|Intent to treat population||ratio||Full Range|Median
721962|NCT00322842|Primary|Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE)|Number of participants with treatment emergent adverse events (TEAEs) collected from Day 1 (start of G-CSF mobilization) to the day before starting chemotherapy (approximately day 38). AEs were graded by the investigator using the World Health Organization (WHO) Adverse Event Grading Scale and were assessed for severity (mild, moderate, severe) and relatedness to study treatment (5 step scale from 'not related' to 'definitely related').|Day 1 to approximately Day 38 (before start of chemotherapy)|Safety population - all participants who received at least 1 dose of plerixafor.||participants|||Number
721963|NCT00322855|Primary|To Review the Outcome of Patients With Soft Tissue Sarcoma Treated With Chemotherapy From 2004 and 2005||up to one year|Study was terminated due to low accrual. This is not an applicable trial; no results to report|||||
721964|NCT00322881|Primary|Therapy Completion Rate|The therapy completion rate is the proportion of patients who completed 6 cycles of carboplatin/paclitaxel therapy without dose reductions.|6 cycles of therapy, up to approximately 4.5 months given the cycle length of 21 days.|The analysis dataset is comprised of all treated patients.||proportion of participants||90% Confidence Interval|Number
721965|NCT00323037|Secondary|Drug Compliance||Up to 32 weeks (titration and maintenance phases)||||||
721966|NCT00323037|Secondary|Safety and Tolerability of Coreg CR||24 weeks after entry into the maintenance phase (after unblinding)||||||
721967|NCT00323037|Secondary|Drug Dose Tolerability||Up to 32 weeks (titration and maintenance phases)||||||
721968|NCT00323037|Secondary|Hospitalizations From All Causes||Up to 32 weeks (titration and maintenance phases)||||||
721969|NCT00323037|Secondary|Incidence of Hospitalizations From Exacerbation of Heart Failure||Up to 32 weeks (titration and maintenance phases)||||||
721970|NCT00323037|Secondary|Change From Baseline in BNP Levels||24 weeks after entry into the maintenance period||||||
721971|NCT00323037|Secondary|Change From Baseline in Left Ventricular Remodeling (IVST, PWT, LVM, ESV, EDV, EDVI, ESD, EDD, Deceleration Time, and E:A Ratio)||24 weeks after entry into the maintenance period||||||
721972|NCT00323037|Secondary|Change From Baseline in Left Ventricular Ejection Fraction||24 weeks after entry into the maintenance period||||||
722033|NCT00323609|Secondary|Change in Global Sagittal Balance.|Change in global sagittal balance as measured by sagittal vertical axis.|Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation|Due to the early termination of the study and having few sites able to image using 3-foot lateral films, sponsor will not carry out the analysis of global sagittal balance in the clinic report.|||||
721973|NCT00323037|Primary|Change From Baseline in Left Ventricular End Systolic Volume Index (LVESVI) Characterized by 2-D Echocardiography|Maintenance Visit 3 minus Baseline. Maintenance Visit 3 occurred 24 weeks after entry into the maintenance period. The maintenance period started after completion of a titration period of variable duration.|24 weeks after entry into the maintenance period|Analysis was performed on the modified intent to treat population (mITT), which were those subjects with both a Baseline and an evaluable End of Study echocardiogram.||mL/m^2||Standard Deviation|Mean
721974|NCT00323115|Secondary|Radiological Response When There is Residual Enhancing Tumor at Baseline MRI||MRI post vaccine||||||
721975|NCT00323115|Secondary|Immunological Parameters With PFS vs Overall Survival||Evaluable patients for immunologic parameters are those who have completed 3 vaccines||||||
721976|NCT00323115|Secondary|Progression Free Survival (PFS)and Overall Survival (OS) Comparison to Prognostic Matched Historical Controls|PFS will be assessed for each patient as the time from surgery until the patient reaches objective disease progression by MRI, defined as greater than or equal to a 25% increase in the product of the largest perpendicular diameters of contrast enhancement of any lesion or any new enhancing tumor on MRI or CT scans.|From Enrollment - March 2011|Surviving patients with no disease progression as of 3/11 - the date used for data collection for publication.||participants|||Number
721977|NCT00323115|Secondary|Feasibility and Toxicity Profile of Intra-nodal DC/Tumor Lysate Vaccination||Pheresis||||||
721978|NCT00323115|Primary|Tumor-specific Cytotoxic T-cell Response|MRI & pheresis post vaccine|Day 42|All participants who received all 3 vaccine administrations were used in this data analysis.||10^9 cells/L||Full Range|Median
721979|NCT00323193|Secondary|Impact of Weight on Quality of Life Survey (IWQOL)|Raw scores for this measure were converted to a range from 0 to 100, with higher scores indicating lower impact of weight on quality of life.|baseline and six months|||units on a scale||Standard Deviation|Mean
721980|NCT00323193|Primary|Weight Measurement|Weight taken at the baseline assessment and again at the 6 month assessment|baseline and six months|||pounds||Standard Deviation|Mean
721981|NCT00323258|Secondary|Death in Intervention Patients Compared to Usual Care|Number of patients who died in each treatment group prior to the 6 month follow-up time point.|6 months|||participants|||Number
721982|NCT00323258|Secondary|Percent of Patients Adherent to Statin Via Refill Records|"According to the local pharmacy records, the patient has had a supply of statin for at least 75% of the days from the day of discharge to 180 days after the discharge date. Refill records from 90 days prior to index admission will be taken into account.
% adherence = (days of available drug supply in the first 180 days/180)*100 If % adherence = or > 75, then adherence = yes"|6 months|Those participants who were living, did not withdraw, and refill records were available from their pharmacy. Missing (n=28)- Refill records not available: 12 intervention and 10 usual care, Died between 0-6 months: 1 intervention and 2 usual care, Withdrew: 1 intervention and 2 usual care.||percentage of patients with >or=75%|||Number
721983|NCT00323258|Secondary|Percent of Patients Adherent to Beta-blocker Via Refill Records|"According to the local pharmacy records, the patient has had a supply of beta-blocker for at least 75% of the days from the day of discharge to 180 days after the discharge date. Refill records from 90 days prior to index admission will be taken into account.
% adherence = (days of available drug supply in the first 180 days/180)*100 If % adherence = or > 75, then adherence = yes"|6 months|Those participants who were living, did not withdraw, and refill records were available from their pharmacy. Missing (n=28)- Refill records not available: 12 intervention and 10 usual care, Died between 0-6 months: 1 intervention and 2 usual care, Withdrew: 1 intervention and 2 usual care.||percentage of patients with PDC >or=75%|||Number
721984|NCT00323258|Secondary|Percent of Patients Adherent to Beta-blocker and Statin Via Refill Records|Percent of patients in each group adherent to beta-blocker and statin for 6 months after discharge as assessed by refill records from the patient's pharmacy|6 months|Those participants who were living, did not withdraw, and refill records were available from their pharmacy. Missing (n=28)- Refill records not available: 12 intervention and 10 usual care, Died between 0-6 months: 1 intervention and 2 usual care, Withdrew: 1 intervention and 2 usual care.||percentage of participants|||Number
721985|NCT00323258|Primary|Patient-reported Adherence to Triple Therapy (Aspirin/Antiplatelet; Beta Blocker; and Statin) at 6 Months|Percent of patients in each group adherent to triple therapy (aspirin/antiplatelet; beta blocker; and statin) 6 months after discharge as assessed by medication history obtained during a follow-up phone call by a blinded pharmacist|6 months|Those participants alive and able to speak to pharmacist on 6 month follow up phone call. Missing (n=35)- Could not be reached: 12 intervention and 11 usual care, Died between 0-6 months: 1 intervention and 2 usual care, Died during call period: 2 intervention and 1 usual care, refused to participate in call: 1 intervention and 5 usual care.||percentage of participants|||Number
721986|NCT00323271|Primary|Pain Intensity|The Numeric Rating Scale of pain intensity (NRS-I) is an 11-point numeric rating scale (0 = no pain, 10 = worst pain imaginable). Participants were asked to rate their usual, worst and least pain over the past week. The average of these numbers will serve as the primary outcome measure.|Baseline to Post Treatment (12 weeks)|Multiple imputation used to account for missing variables; pre-treatment rating and years of MS pain were covariates||units on a scale||Standard Deviation|Mean
721987|NCT00323271|Primary|Pain Intensity|The Numeric Rating Scale of pain intensity (NRS-I) is an 11-point numeric rating scale (0 = no pain, 10 = worst pain imaginable). Participants were asked to rate their usual, worst and least pain over the past week. The average of these numbers will serve as the primary outcome measure.|baseline|||units on a scale||Standard Deviation|Mean
721988|NCT00323284|Secondary|Efficacy|Subjects with an intraocular pressure (IOP) reduction from baseline of greater than or equal to 20% without use of topical hypotensive medication at 12 months|12 months|Intent to treat population using non-responder approach||percent||95% Confidence Interval|Number
721989|NCT00323284|Primary|Intraocular Pressure (Measured in mm Hg) Less or Equal to 21 mm Hg on no Topical Hypotensive Meds|Subjects with an intraocular pressure (IOP) less than or equal to 21 mm Hg without use of topical hypotensive medication at 12 months|12 months|Intent to treat analysis of all enrolled subjects using non-responder approach||percent of subjects achieving endpoint||95% Confidence Interval|Number
722073|NCT00323869|Secondary|Time-to-First Event|Median time-to-first event, with events defined as disease progression, death, or toxicity requiring drug discontinuation|18 months|Includes all subjects who initiated treatment||months||95% Confidence Interval|Median
721990|NCT00323297|Secondary|One Year Survival From the Start of Sildenafil Treatment.|The survival status of all participants who discontinued from the study, including those participants who discontinued during the double-blind phase, was to be assessed at one year post their Week 12 visit/ End of treatment visit.|One year from the time of starting sildenafil|ITT Population (Full Analysis Set) consisted of all participants who had been randomly assigned to study drug and received at least one dose of study medication. Missing values were replaced according to the last observation carried forward LOCF approach. The participants in placebo arm have received Sildenafil on or after Week 12.||Participants who died|||Number
721991|NCT00323297|Secondary|One Year Survival Probability From the Start of Sildenafil Treatment.|The survival probability of all participants up to 1-year post start of Sildenafil treatment; for participants who were randomized to Sildenafil, this was the week 52 from randomization, and for participants who were originally randomized to Placebo group, this was the Week 64 from Baseline (Week 52 from Week 12, when the first dose of Sildenafil was administered to these participants). Those participants who discontinued from the study prior to 1 year after start of sildenafil were considered as censored at the time of discontinuation and those who discontinued from the study post 1-year after start of sildenafil were considered as censored at the time of 1-year post start of sildenafil.|One year from the time of starting sildenafil|ITT Population (Full Analysis Set) consisted of all participants who had been randomly assigned to study drug and received at least one dose of study medication. Missing values were replaced according to the last observation carried forward LOCF approach. The participants in placebo arm have received Sildenafil on or after Week 12.||Probability of death||90% Confidence Interval|Number
721992|NCT00323297|Secondary|Change From Baseline in Borg Dyspnea Score at Week 12|"Borg dyspnea scale is a 10-point scale where following scores stands for severity of dyspnea: 0 (no breathlessness at all); 0.5 (very very slight [just noticeable]);
(very slight);
(slight breathlessness);
(moderate); 4 (some what severe);
5 (severe breathlessness); 7 (very severe breathlessness); 9 (very very severe [almost maximum]); and 10 (maximum)."|Week 12|ITT Population (Full Analysis Set) consisted of all participants who had been randomly assigned to study drug and received at least one dose of study medication. Missing values were replaced according to the last observation carried forward LOCF approach.||Units on a scale||Standard Deviation|Mean
721993|NCT00323297|Secondary|Clinical Worsening Events|"No survival analysis was carried out for the study due to very few events of clinical worsening. Hence, we present a summary of clinical worsening events instead.
Events of clinical worsening were categorized as (A). Death, (B). Heart/lung transplantation, (C). Hospitalization due to pulmonary arterial hypertension (PAH), and (D). Clinical deterioration of PAH requiring additional therapy."|Week 12|ITT Population (Full Analysis Set) consisted of all participants who had been randomly assigned to study drug and received at least one dose of study medication.||Participants|||Number
721994|NCT00323297|Secondary|Number of Participants With Change From Baseline in World Health Organization (WHO) Functional Class in Participants With PAH at Week 12 LOCF|WHO functional classification for PAH range from Class I (no limitation in physical activity, no dyspnea with normal activity) to Class IV (can not perform a physical activity without any symptoms, dyspnea at rest). Improvement=reduction in functional class; deterioration = increase in functional class, no change = no change in functional class.|Week 12|ITT Population (Full Analysis Set) consisted of all participants who had been randomly assigned to study drug and received at least one dose of study medication. Missing values were replaced according to the LOCF approach.||Participants|||Number
721995|NCT00323297|Primary|Change From Baseline in the Total Distance Walked During 6 Minute Walk Time (6MWT) at Week 12|6MWT is the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. Continuous pulse oximetry was conducted during the test for safety.|Week 12|Intent-to-Treat (ITT) Population (Full Analysis Set) consisted of all participants who had been randomly assigned to study drug and received at least one dose of study medication. Missing values were replaced according to the last observation carried forward (LOCF) approach. Statistical analysis was carried out on LOCF values.||Meters||Standard Deviation|Mean
721996|NCT00323310|Primary|The Number of Patients Administered MultiHance (Gadobenate Dimeglumine) Reporting Adverse Events||up to 72 hours post dose|Included all dosed patients (safety population).||Participants|||Number
721997|NCT00323310|Primary|Lesion Contrast Enhancement (CE) (Change From Pre to Pre+Postdose) for Reader 3|5-point scale (0=no lesion CE [lesion not identified in image, no contrast between lesion and surrounding normal brain/spine tissue]; 1=poor lesion CE [diff. in signal intensity (SI) poor, lesion barely identified, not possible to evaluate/measure size]; 2=moderate lesion CE [diff. in SI fair, lesion identified, not possible to evaluate/measure size]; 3=good lesion CE [diff. in SI adequate, lesion identified, size evaluated/measured]; 4=excellent lesion CE [diff. in SI marked, lesion identified, size measured]) paired assessment to compare the diff. between pre to pre+postdose|pre-dose to immediately postdose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants.||Units on a Scale (0 to 4)|Participants|Standard Deviation|Mean
721998|NCT00323310|Primary|Lesion Contrast Enhancement (CE) (Change From Pre to Pre+Postdose) for Reader 2|5-point scale (0=no lesion CE [lesion not identified in image, no contrast between lesion and surrounding normal brain/spine tissue]; 1=poor lesion CE [diff. in signal intensity (SI) poor, lesion barely identified, not possible to evaluate/measure size]; 2=moderate lesion CE [diff. in SI fair, lesion identified, not possible to evaluate/measure size]; 3=good lesion CE [diff. in SI adequate, lesion identified, size evaluated/measured]; 4=excellent lesion CE [diff. in SI marked, lesion identified, size measured]) paired assessment to compare the diff. between pre to pre+postdose|pre-dose to immediately postdose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants.||Units on a Scale (0 to 4)|Participants|Standard Deviation|Mean
722031|NCT00323557|Primary|Number of Participants (With Increase) Immune Response to GM-CSF With a Pneumococcal Vaccine|Response defined as 2-fold rise in anticapsular immunoglobulin G (IgG) when prevaccination titer is compared with levels post vaccination and with a final level of >0.5 ug/mL. Anti-pneumococcal immunoglobulin titers measured at baseline and 1 month after vaccine. Response determined by measuring serum IgG to capsular polysaccharides from 6 of the most common infecting serotypes of Streptococcus pneumoniae.|Baseline and at 1 month after vaccine.|||participants|||Number
722074|NCT00323869|Secondary|Stable Disease (SD)|Number of subjects with SD per RECIST criteria|6 weeks|Includes all subjects who initiated treatment||participants|||Number
721999|NCT00323310|Primary|Lesion Contrast Enhancement (CE) (Change From Pre to Pre+Postdose) for Reader 1|5-point scale (0=no lesion CE [lesion not identified in image, no contrast between lesion and surrounding normal brain/spine tissue]; 1=poor lesion CE [diff. in signal intensity (SI) poor, lesion barely identified, not possible to evaluate/measure size]; 2=moderate lesion CE [diff. in SI fair, lesion identified, not possible to evaluate/measure size]; 3=good lesion CE [diff. in SI adequate, lesion identified, size evaluated/measured]; 4=excellent lesion CE [diff. in SI marked, lesion identified, size measured]) paired assessment to compare the diff. between pre to pre+postdose|pre-dose and immediately postdose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants.||Units on a Scale (0 to 4)|Participants|Standard Deviation|Mean
722000|NCT00323310|Primary|Visualization of Lesion Internal Morphology (Change From Pre to Pre+Postdose) for Reader 3|5-point scale (0=no visualization of lesion internal morphology (LIM) [lesion not identified in image, not visible]; 1=poor visualization of LIM [insufficiently depicted, intralesional features poorly identified]; 2=moderate visualization of LIM [not completely depicted, some intralesional features visible]; 3=good visualization of LIM [completely depicted, intralesional features adequately identified]; 4=excellent visualization of LIM [optimally depicted, intralesional features clearly identified and characterized]) paired assessment to compare the difference between pre to pre+postdose|pre-dose to immediately postdose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants.||Units on a Scale (0 to 4)|Participants|Standard Deviation|Mean
722001|NCT00323310|Primary|Visualization of Lesion Internal Morphology (Change From Pre to Pre+Postdose) for Reader 2|5-point scale (0=no visualization of lesion internal morphology (LIM) [lesion not identified in image, not visible]; 1=poor visualization of LIM [insufficiently depicted, intralesional features poorly identified]; 2=moderate visualization of LIM [not completely depicted, some intralesional features visible]; 3=good visualization of LIM [completely depicted, intralesional features adequately identified]; 4=excellent visualization of LIM [optimally depicted, intralesional features clearly identified and characterized]) paired assessment to compare the difference between pre to pre+postdose|pre-dose to immediately post dose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants.||Units on a Scale (0 to 4)|Participants|Standard Deviation|Mean
722002|NCT00323310|Primary|Visualization of Lesion Internal Morphology (Change From Pre to Pre+Postdose) for Reader 1|5-point scale (0=no visualization of lesion internal morphology (LIM) [lesion not identified in image, not visible]; 1=poor visualization of LIM [insufficiently depicted, intralesional features poorly identified]; 2=moderate visualization of LIM [not completely depicted, some intralesional features visible]; 3=good visualization of LIM [completely depicted, intralesional features adequately identified]; 4=excellent visualization of LIM [optimally depicted, intralesional features clearly identified and characterized]) paired assessment to compare the difference between pre to pre+postdose|pre-dose to immediately post dose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants.||Units on a Scale (0 to 4)|Participants|Standard Deviation|Mean
722003|NCT00323310|Primary|Delineation of Lesion Border (Change From Pre to Pre+Postdose) for Reader 3|5-point scale (0=no delineation of lesion borders [lesion not identified in image, lesion borders not visible]; 1=poor border delineation [all borders poorly distinct, lesion not separated from surrounding tissues/structures/edema]; 2=moderate border delineation [border delineation fair/not complete, lesion not clearly separated]; 3=good border delineation [border delineation complete, lesion adequately separated]; 4=excellent border delineation [borders sharply/clearly distinct, lesion sharply separated]) paired assessment to compare the difference between pre to pre+postdose|pre-dose and immediately postdose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants.||Units on a Scale (0 to 4)|Participants|Standard Deviation|Mean
722004|NCT00323310|Primary|Delineation of Lesion Border (Change From Pre to Pre+Postdose) for Reader 2|5-point scale (0=no delineation of lesion borders [lesion not identified in image, lesion borders not visible]; 1=poor border delineation [all borders poorly distinct, lesion not separated from surrounding tissues/structures/edema]; 2=moderate border delineation [border delineation fair/not complete, lesion not clearly separated]; 3=good border delineation [border delineation complete, lesion adequately separated]; 4=excellent border delineation [borders sharply/clearly distinct, lesion sharply separated]) paired assessment to compare the difference between pre to pre+postdose|pre-dose and immediately postdose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants.||Units on a Scale (0 to 4)|Participants|Standard Deviation|Mean
722005|NCT00323310|Primary|Delineation of Lesion Border (Change From Pre to Pre+Postdose) for Reader 1|5-point scale (0=no delineation of lesion borders [lesion not identified in image, lesion borders not visible]; 1=poor border delineation [all borders poorly distinct, lesion not separated from surrounding tissues/structures/edema]; 2=moderate border delineation [border delineation fair/not complete, lesion not clearly separated]; 3=good border delineation [border delineation complete, lesion adequately separated]; 4=excellent border delineation [borders sharply/clearly distinct, lesion sharply separated]) paired assessment to compare the difference between pre to pre+postdose|pre-dose and immediately postdose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants.||Units on a Scale (0 to 4)|Participants|Standard Deviation|Mean
722006|NCT00323362|Secondary|1-year Survival|Accrual duration is 2 years with an additional year for assessment of 1-year survival. Outcome measure time frame is about 3 years.|3 years|The study was closed early due to toxicity and insufficient data were collected to analyze this outcome measure.||percentage of patients|||Number
722007|NCT00323362|Secondary|Time to Progression||2 years|The study was closed early due to toxicity and insufficient data were collected to analyze this outcome measure.||months||Standard Deviation|Mean
722032|NCT00323609|Secondary|VCF-related Health Care Utilization|Health care utilization assessments conducted by monthly phone call to participating patients.|Monthly for 24 months post-op|Due to the early termination of the study, sponsor will not carry out the analysis of secondary healthcare utilization endpoints.|||||
722075|NCT00323869|Secondary|Complete Response (CR)|Number of subjects with CR per RECIST criteria|6 weeks|Includes all subjects who initiated treatment||participants|||Number
722008|NCT00323362|Primary|Percentage of Patients Who Meet Critieria for Response|"Response is considered Partial Response or Complete Response as per RECIST criteria.
Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started."|2 years|Fourteen subjects were evaluable for response. Three subjects were not assessed.||percentage of patients who responded|||Number
722009|NCT00323427|Primary|Communication Profile for Hearing Impaired : Non-verbal Strategies Subscale|"The Communication Profile for Hearing Impaired (CPHI) queries subjects on how well they can communicate with others.
The Non-verbal Strategies subscale describe adaptive coping strategies but they describe unobtrusive, nonverbal behaviors that the individual can use to maximize communication effectiveness.
8 week change score from baseline value.
Larger values of the change score indicate more use of adaptive non-verbal behaviors.
Larger group mean change score indicates BETTER performance on this scale.
The CPHI Non-verbal strategies score ranges from 1 (worse) to 5 (better) usage of non-verbal strategies."|8-weeks post-baseline relative to baseline|Intent-to-Treat||score on a scale.||Standard Deviation|Mean
722010|NCT00323427|Primary|Communication Profile for Hearing Impaired: Verbal Strategies Subscale|"The Communication Profile for Hearing Impaired (CPHI) queries subjects on how well they can communicate with others.
The Verbal Strategies subscale describe adaptive strategies for coping with the effects of hearing impairment on communication.
8 week change score from baseline value.
Larger values of the change score indicate more use of adaptive Verbal Strategies.
Larger group mean change score indicates BETTER performance on this scale.
CPHI Verbal Strategies scores vary from 1 (worse) to 5 (best) strategy usage."|8 weeks post-baseline relative to baseline|Intent to treat||score on a scale||Standard Deviation|Mean
722011|NCT00323427|Primary|Communication Profile for Hearing Impaired: Maladaptive Strategies Subscale|"The Communication Profile for Hearing Impaired (CPHI) queries subjects on how well they can communicate with others.
The Maladaptive strategies subscale describe behaviors that prevent the individual from coping effectively with communication problems.
8 week change score from baseline value. Larger values of the change score indicate less use of maladaptive behaviors. Larger group mean change score indicates BETTER performance on this scale.
CPHI Maladaptive strategies subscale ranges from 1 (better) to 5 (worse) maladaptive strategy usage."|8 weeks post-baseline relative to baseline|Intent-to-treat (ITT)||score on a scale||Standard Deviation|Mean
722012|NCT00323479|Secondary|Percentage of Participant With Therapeutic Maintenance Under Anastrozole|Treatment compliance. results based on 109 patients due to missing values|12 months|||percentage of participants|||Number
722013|NCT00323479|Secondary|Synovial Membrane Thickness at 12 Months in Patients Under Anastrozole|X ray assessment on hands and wrists based on 99 patients due to missing values|12 months|||millimeter||Standard Deviation|Median
722014|NCT00323479|Secondary|Kellgren and Lawrence Score at 12 Months in Patients Under Anastrozole|X ray evaluation of arthritis in 30 articulations ; each articulation scored from (0 = no arthritis to 4 = severe arthritis) based on 92 patients due to missing values|12 months|||Units on scale||Standard Deviation|Mean
722015|NCT00323479|Secondary|Serum Collagen Degradation Type I - CTX-I at 12 Months in Patients Under Anastrozole|Results are based on 97 patients due to missing values|12 months|||Ng/mL||Standard Deviation|Mean
722016|NCT00323479|Secondary|Functional Index of Cochin at 12 Months in Patients Under Anastrozole.|Functional index of cochin score (from 0 to 90) : sum up of 18 questions on activities involving hands (each question scored from 0 = yes without difficulties (best) to 5 = impossible (worst)) based on 99 patients due to missing values.|12 months|||Units on scale||Standard Deviation|Mean
722017|NCT00323479|Primary|Number of Participants With New Events of Arthralgia||12 months|||Participants|||Number
722018|NCT00323492|Secondary|Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48||48 weeks|ITT. Missing values were treated as failure.||Percentage of participants|||Number
722019|NCT00323492|Secondary|Percentage of Participants With Plasma HIV-1 RNA Greater Than or Equal to 400 Copies/mL at Week 12||12 weeks|ITT. Missing values were excluded. Any subjects with plasma HIV-1 RNA greater than or equal to 400 copies/mL at Week 12 were to have virologic genotyping performed.||Percentage of participants|||Number
722020|NCT00323492|Secondary|Percentage of Participants With Virologic Control (Plasma HIV-1 Ribonucleic Acid [RNA] < 400 Copies/mL) at Week 12||12 weeks|ITT. Missing values were treated as failure.||Percentage of participants|||Number
722021|NCT00323492|Secondary|Change From Baseline to Week 48 in CD4 Cell Count|Change = Week 48 value minus baseline value.|Baseline to Week 48|ITT. Missing values were excluded.||cells/mm^3||Inter-Quartile Range|Median
722022|NCT00323492|Secondary|Change From Baseline to Week 12 in Cluster Determinant 4 (CD4) Cell Count|Change = Week 12 value minus baseline value.|Baseline to Week 12|ITT. Missing values were excluded.||cells/mm^3||Inter-Quartile Range|Median
722023|NCT00323492|Secondary|Percentage of Participants With Fasting Plasma Triglycerides > 10 g/L (> 11.29 mmol/L) at Week 12|Centralized laboratory assessment|12 weeks|ITT. Missing values were excluded.||Percentage of participants|||Number
722024|NCT00323492|Secondary|Change From Baseline to Week 12 in Fasting Ultra-sensitive C-reactive Protein (Us-CRP)|Local laboratory assessment. Change = Week 12 value minus baseline value.|Baseline to Week 12|ITT. Missing values were excluded. Assessment of us-CRP was added to the study schedule via protocol amendment part way through the study. This resulted in small numbers of subjects having data available for this analysis.||mg/L||Inter-Quartile Range|Median
722025|NCT00323492|Secondary|Change From Baseline to Week 12 in Fasting HDL-CHO/LDL-CHO|Centralized laboratory assessment. Change = Week 12 value minus baseline value.|Baseline to Week 12|ITT. Missing values were excluded.||Ratio||Inter-Quartile Range|Median
722026|NCT00323492|Secondary|Change From Baseline to Week 12 in Fasting T-CHO/HDL-CHO|Centralized laboratory assessment. Change = Week 12 value minus baseline value.|Baseline to Week 12|ITT. Missing values were excluded.||Ratio||Inter-Quartile Range|Median
722027|NCT00323492|Secondary|Change From Baseline to Week 12 in Fasting Total Cholesterol (T-CHO)|Centralized laboratory assessment. Change = Week 12 value minus baseline value.|Baseline to Week 12|ITT. Missing values were excluded.||mmol/L||Inter-Quartile Range|Median
722034|NCT00323609|Secondary|Change in Vertebral Body Local Cobb Angle (LCA)|The vertebral body local Cobb angle is a measurement of the 3-level functional unit consisting of the treated fractured vertebral body and the nearest adjacent vertebrae and is defined as the angle formed by lines drawn parallel to the superior endplate of the cranial adjacent vertebral body and the inferior endplate of the adjacent caudal vertebral body.|Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation|Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data (vertebrae) at each time point are indicated. The number of participants analyzed in 'Change in Vertebral Body Local Cobb Angle' represents number of subjects with radiographic data available for analysis.||degree|treated vertebrae|Standard Deviation|Mean
722035|NCT00323609|Secondary|Change in Vertebral Body Kyphosis Angle|The vertebral kyphosis angle was defined as the angle formed by lines drawn parallel to the superior and inferior endplates of the treated fractured vertebral body.|Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation|Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data (vertebrae) at each time point are indicated. The number of participants analyzed in 'Change in Vertebral Body Kyphosis Angle' represents number of subjects with radiographic data available for analysis.||degree|treated vertebrae|Standard Deviation|Mean
722036|NCT00323609|Secondary|Change in Posterior Vertebral Body Height||Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation|Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data (vertebrae) at each time point are indicated. The number of participants analyzed in 'Change in Posterior Vertebral Body Height' represents number of subjects with radiographic data available for analysis.||mm|treated vertebrae|Standard Deviation|Mean
722037|NCT00323609|Secondary|Change in Middle Vertebral Body Height||Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation|Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data (vertebrae) at each time point are indicated. The number of participants analyzed in 'Change in Middle Vertebral Body Height' represents number of subjects with radiographic data available for analysis.||mm|treated vertebrae|Standard Deviation|Mean
722038|NCT00323609|Secondary|Change in Anterior Vertebral Body Height||Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation|Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data (vertebrae) at each time point are indicated. The number of participants analyzed in 'Change in Anterior Vertebral Body Height' represents number of subjects with radiographic data available for analysis.||mm|treated vertebrae|Standard Deviation|Mean
722039|NCT00323609|Secondary|Rate of Procedure/Device Related or Possibly Related Serious Adverse Events at 30 Days|Rate of Procedure/Device related or possibly related serious adverse events is presented as the percentage of the participants who reported Procedure/Device related or possibly related serious adverse events within 30 days after initial treatment.|30 days post-operation|Intent to treat population comprised of all subjects randomized and had initial treatment carried out.||percentage of participants|||Number
722040|NCT00323609|Primary|Percent of Subjects With One or More Subsequent Radiographic Fractures 24 Months||24 months|Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data at 24-months is indicated.||percentage of participants|||Number
722041|NCT00323609|Secondary|Rate of Serious Adverse Events at 30 Days|Rate of serious adverse events is presented as the percentage of the participants who reported serious adverse events within 30 days after initial treatment. For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.|30 days post-operation|Intent to treat population comprised of all subjects randomized and had initial treatment carried out.||percentage of participants|||Number
722042|NCT00323609|Secondary|Quality of Life -- EQ5D Index|EQ-5D index scores range from 0 to 1.0 on a scale where 0 = death and 1.0 = perfect health.|30 days, 3 months, 12 months, 24 months post-operation|Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data at each time point are indicated; for subjects who have secondary surgery, the last value before the first secondary surgery was carried forward to the later time points.||units on a scale||Standard Deviation|Mean
722043|NCT00323609|Secondary|Quality of Life by SF-36|The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results are summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS and MCS is between 0 and 100, with higher scores denoting better quality of life.|30 days, 3 months, 12 months, 24 months post-operation|Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data at each time point are indicated; for subjects who have secondary surgery, the last value before the first secondary surgery was carried forward to the later time points.||units on a scale||Standard Deviation|Mean
722044|NCT00323609|Secondary|Back Function-Oswestry Disability Index|The Oswestry Disability Index (ODI) Questionnaire was used to assess patient back function. The ODI score ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability).|30 days, 3 months, 12 months, 24 months post-operation|Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data at each time point are indicated; for subjects who have secondary surgery, the last value before the first secondary surgery was carried forward to the later time points.||units on a scale||Standard Deviation|Mean
722045|NCT00323609|Secondary|Back Pain|Back pain was assessed on a 10-point Numerical Rating Scale (NRS) from 0 (no pain) to 10 (worst possible pain).|7 days, 30 days, 3 months, 12 months, 24 months post-operation|Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data at each time point are indicated; for subjects who have secondary surgery, the last value before the first secondary surgery was carried forward to the later time points.||units on a scale||Standard Deviation|Mean
722046|NCT00323609|Primary|Percent of Subjects With One or More Subsequent Radiographic Fractures at 12 Months||12 months|Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data at 12-months is indicated.||percentage of participants|||Number
722047|NCT00323622|Secondary|Number of Subjects Prevalent for Plasmodium Falciparum (P. Falciparum) Parasitemia|Subjects prevalent for P. falciparum parasitemia were defined as subjects with the presence of P. falciparum asexual parasitemia above 0 per microliter (µL) on Giemsa stained thick blood films.Analysis for this outcome was performed on Cohort 1 subjects solely, with groups pooled across age ranges.|At Months 33 (M33) and 45 (M45) (Month 0 = administration of Dose 1 of RTS,S/AS02A or comparator vaccine in the NCT00197041 study).|The analysis was performed on the According-to-Protocol cohort for efficacy, which included all evaluable subjects who had received the 3 doses of the RTS,S/AS02 or control vaccine(s) in the Primary NCT00197041, and with available data concerning efficacy measures starting 14 days post Dose 3 of RTS,S/AS02A or comparator vaccine(s).||Subjects|||Number
722048|NCT00323622|Secondary|Number of Subjects With Anemia.|Anemia was indicated by a hematocrit level (HL) below (<) 25%. The numbers of subjects with HL below (<) and above or equal (≥) 25 %, and with missing HL results were tabulated. In the tabulation below, the number of subjects falling into the “HL ≥25%” category corresponds to the number of subjects with anemia as asked per outcome. Analysis for this outcome was performed on Cohort 1 subjects solely, with groups pooled across age ranges.|At Months 33 and 45 (Month 0 = administration of Dose 1 of RTS,S/AS02A or comparator vaccine in the NCT00197041 study).|The analysis was performed on the According-to-Protocol cohort for efficacy, which included all evaluable subjects who had received the 3 doses of the RTS,S/AS02 or control vaccine(s) in the Primary NCT00197041, and with available data concerning efficacy measures starting 14 days post Dose 3 of RTS,S/AS02A or comparator vaccine(s).||Subjects|||Number
722049|NCT00323622|Secondary|Number of Primary Case Definition Clinical Episodes of Symptomatic Plasmodium Falciparum Malaria Infection (PFMI)|PFMI was detected by passive case detection. A symptomatic PFMI episode of Primary Case Definition (PCD) was defined as the presence of P. falciparum asexual parasitaemia above 2500 per µL on Giemsa stained thick blood films accompanied by fever (axillary temperature equal or above 37.5 degrees Celsius at the time of presentation) occurring in an unwell child brought for treatment to a healthcare facility. The number of PFMI episodes (EPFMI) per person-year (pyr) was tabulated, using as unit EPFMI episode per pyr. Analysis for this outcome was performed on Cohort 1 subjects solely, with groups pooled across age ranges.|From Month 21 to Month 33 (M21-33), and from Month 33 to Month 45 (M33-45). Month 0 = administration of Dose 1 of RTS,S/AS02A or comparator vaccine in study NCT00197041|The analysis was performed on the According-to-Protocol cohort for efficacy, which included all evaluable subjects who had received the 3 doses of the RTS,S/AS02 or control vaccine(s) in the Primary NCT00197041, and with available data concerning efficacy measures starting 14 days post Dose 3 of RTS,S/AS02A or comparator vaccine(s).||EPFMI episode per pyr|||Number
722050|NCT00323622|Secondary|Time to First or Only Episode of Symptomatic Plasmodium Falciparum Malaria Infection (PFMI) of Secondary Case Definition 3|PFMI was detected by passive case detection. Symptomatic PFMI of Secondary Case Definition (SCD) 3 was defined as the presence of P. falciparum asexual parasitaemia above 15000 per microliter (µL) on Giemsa stained thick blood films accompanied by fever (axillary temperature equal or above 37.5 degrees Celsius) in an unwell child brought for treatment to a healthcare facility. The time to first or only episode of symptomatic PFMI is expressed in terms of rate of first PFMI (RPFMI), that is, the number of PFMI events reported (n) over the period elapsed until the PFMI event occurred (i.e. events per Persons Year at Risk [PYAR]) for each group. Analysis for this outcome was performed on Cohort 1 subjects solely, with groups pooled across age ranges.|From Month 21 to Month 33 (M21-33), and from Month 33 to Month 45 (M33-45). Month 0 = administration of Dose 1 of RTS,S/AS02A or comparator vaccine in study NCT00197041|The analysis was performed on the According-to-Protocol cohort for efficacy, which included all evaluable subjects who had received the 3 doses of the RTS,S/AS02 or control vaccine(s) in the Primary NCT00197041, and with available data concerning efficacy measures starting 14 days post Dose 3 of RTS,S/AS02A or comparator vaccine(s).||n/PYAR|||Number
722051|NCT00323622|Secondary|Time to First or Only Episode of Symptomatic Plasmodium Falciparum Malaria Infection (PFMI) of Secondary Case Definition 2|PFMI was detected by passive case detection. Symptomatic PFMI of Secondary Case Definition (SCD) 2 was defined as the presence of P. falciparum asexual parasitaemia (any level if parasitemia) on Giemsa stained thick blood films in an unwell child brought for treatment with a history of fever (axillary temperature equal or above 37.5 degrees Celsius) within 24 hours or documented fever. The time to first or only episode of symptomatic PFMI is expressed in terms of rate of first PFMI (RPFMI), that is, the number of PFMI events reported (n) over the period elapsed until the PFMI event occurred (i.e. events per Persons Year at Risk [PYAR]) for each group. Analysis for this outcome was performed on Cohort 1 subjects, with groups pooled across age ranges.|From Month 21 to Month 33 (M21-33), and from Month 33 to Month 45 (M33-45). Month 0 = administration of Dose 1 of RTS,S/AS02A or comparator vaccine in study NCT00197041|The analysis was performed on the According-to-Protocol cohort for efficacy, which included all evaluable subjects who had received the 3 doses of the RTS,S/AS02 or control vaccine(s) in the Primary NCT00197041, and with available data concerning efficacy measures starting 14 days post Dose 3 of RTS,S/AS02A or comparator vaccine(s).||n/PYAR|||Number
722052|NCT00323622|Secondary|Time to First or Only Episode of Symptomatic Plasmodium Falciparum Malaria Infection (PFMI) of Secondary Case Definition 1|PFMI was detected by passive case detection. Symptomatic PFMI of Secondary Case Definition (SCD) 1 was defined as the presence of P. falciparum asexual parasitaemia (any level if parasitemia) on Giemsa stained thick blood films accompanied by fever (axillary temperature equal or above 37.5 degrees Celsius) in an unwell child brought for treatment. The time to first or only episode of symptomatic PFMI is expressed in terms of rate of first PFMI (RPFMI), that is, the number of PFMI events reported (n) over the period elapsed until the PFMI event occurred (i.e. events per Persons Year at Risk [PYAR]) for each group. Analysis for this outcome was solely performed on Cohort 1 subjects, with groups pooled across age ranges.|From Month 21 to Month 33 (M21-33), and from Month 33 to Month 45 (M33-45). Month 0 = administration of Dose 1 of RTS,S/AS02A or comparator vaccine in study NCT00197041|The analysis was performed on the According-to-Protocol cohort for efficacy, which included all evaluable subjects who had received the 3 doses of the RTS,S/AS02 or control vaccine(s) in the Primary NCT00197041, and with available data concerning efficacy measures starting 14 days post Dose 3 of RTS,S/AS02A or comparator vaccine(s).||n/PYAR|||Number
722076|NCT00323869|Secondary|Partial Response (PR)|Number of subjects with PR per RECIST criteria|6 weeks|Includes all subjects who initiated treatment||participants|||Number
722077|NCT00323869|Secondary|Overall Survival (OS)|To evaluate the safety of the combination regimen.|36 months|Includes all subjects who initiated treatment||months||95% Confidence Interval|Median
722053|NCT00323622|Secondary|Time to First or Only Clinical Episode of Symptomatic Plasmodium Falciparum Malaria Infection (PFMI) of Primary Case Definition|Malaria infection by Plasmodium falciparum was detected by passive case detection. A symptomatic PFMI episode of Primary Case Definition (PCD) was defined as the presence of P. falciparum asexual parasitaemia above 2500 per µL on Giemsa stained thick blood films accompanied by fever (axillary temperature equal or above 37.5 degrees Celsius at the time of presentation) occurring in an unwell child brought for treatment to a healthcare facility. The time to first or only episode of symptomatic PFMI is expressed in terms of rate of first PFMI (RPFMI), that is, the number of PFMI events reported (n) over the period elapsed until the PFMI event occurred (i.e. events per Persons Year at Risk [PYAR]) for each group. Analysis for this outcome was solely performed on Cohort 1 subjects, with groups pooled across age ranges.|From Month 21 to Month 33 (M21-33), and from Month 33 to Month 45 (M33-45). Month 0 = administration of Dose 1 of RTS,S/AS02A or comparator vaccine in study NCT00197041|The analysis was performed on the According-to-Protocol cohort for efficacy, which included all evaluable subjects who had received the 3 doses of the RTS,S/AS02 or control vaccine(s) in the Primary NCT00197041, and with available data concerning efficacy measures starting 14 days post Dose 3 of RTS,S/AS02A or comparator vaccine(s).||n/PYAR|||Number
722054|NCT00323622|Secondary|Anti-hepatitis B (HBs) Antibody Concentrations.|Concentrations are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL). Anti-HBs antibody concentration levels were measured in blood samples from Cohort 2 only.|At Months 33 and 45 (Month 0 = administration of Dose 1 of RTS,S/AS02A or comparator vaccine in the NCT00197041 study).|The Long Term According-to-Protocol (ATP) cohort for immunogenicity included all enrolled subjects from the primary study ATP cohort for immunogenicity who did not receive any additional vaccine dose containing circumsporozoite protein or hepatitis B antigens,with blood sample within protocol-defined time limits and available antibody measurements.||mIU/mL||95% Confidence Interval|Geometric Mean
722055|NCT00323622|Secondary|Anti-circumsporozoite Protein (CS) Antibody Concentrations.|Concentrations for anti-CS antibodies are presented as Geometric Mean Concentrations (GMCs), expressed in Enzyme-Linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL). The cut-off of the assay was the seropositivity cut-off of 0.5 EL.U/mL. Subjects were pooled across age ranges for this outcome measure.|At Months 33 and 45 (Month 0 = administration of Dose 1 of RTS,S/AS02A or comparator vaccine in the NCT00197041 study).|The Long Term According-to-Protocol (ATP) cohort for immunogenicity included all enrolled subjects from the primary study ATP cohort for immunogenicity who did not receive any additional vaccine dose containing circumsporozoite protein or hepatitis B antigens, with blood sample within protocol-defined time limits and available antibody measurements||EL.U/mL||95% Confidence Interval|Geometric Mean
722056|NCT00323622|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Throughout the entire study period: from Month 21 to Month 45 (Month 0 = administration of Dose 1 of RTS,S/AS02A or comparator vaccine in the NCT00197041 study).|The analysis was performed on the Total Vaccinated cohort, which included all subjects vaccinated in the primary NCT00197041 study, and re- enrolled in this follow-up NCT 00323622 study, and for whom data were available.||Subjects|||Number
722057|NCT00323635|Primary|Relationship of Incontinence to Urge or Stress|4-grade scale|Duration of study|Study prematurely stopped|||||
722058|NCT00323635|Primary|Number of Incontinence Episodes;|Number|Duration of Study|Study prematurely stopped|||||
722059|NCT00323635|Secondary|Pads Used|Pads used|Duration of Study|Study prematurely stopped|||||
722060|NCT00323635|Secondary|Whether She Used Any Pads.|Yes/No|Duration of Study|Study prematurely stopped|||||
722061|NCT00323635|Primary|Urgency|Level of urgency for 7 days, graded 1 to 4,|Beginning after the first void on the Friday morning of week 7 and week 13 of their participation;|Study prematurely stopped|||||
722062|NCT00323635|Other Pre-specified|Sleep / Wake Pattern|Wrist actigraphy measures of total daytime and nighttime activity scored by standardized Actiwatch measures of sleep and sake.|Two weeks||||||
722063|NCT00323635|Secondary|Hyperarousal|Score on 26-item self-report Hyperarousal Scale that indicates proportion of attention allocated to visceral-somatic information vs. external sensory data.|At baseline and 8 weeks later||||||
722064|NCT00323635|Secondary|Cognitive Function|Motor speed (number of finger taps in 30 seconds); Continuous Performance (mean response time elicited by appearance of target alphabet letter presented in a series of letters on a monitor screen for 1 minute); Color-Word Stroop Test (response times to stimuli with congruent word and color)|Two 20-minute sessions during 2 months||||||
722065|NCT00323635|Secondary|Sleep Quality||2 months||||||
722066|NCT00323635|Secondary|Quality of Life, Scores on the Women's Health Questionnaire.|Self-reported vasomotor symptoms, other somatic symptoms, anxiety, depression, sleep and cognitive symptoms (memory, concentration and clumsiness problems), measured as category scores. Subjective sleep onset and total sleep times measured as 7-day averaged minutes.|2 weeks||||||
722067|NCT00323635|Secondary|Psychological Self-reports, Scores on Anxiety and Depression Rating Scales;|State and Trait scores on Spielberger State-Trait Anxiety Inventory; The score measured by the Zung Self-Rating Depression Inventory.|2 weeks||04/2013||||
722068|NCT00323635|Primary|Nocturnal Urinary Frequency, Recorded on an Event/Symptom Chart;|Subjects note: 1. Number of nocturnal and diurnal voids; 2) level of urgency for 7 days, graded 1 to 4, beginning after the first void on the Friday morning of week 7 and week 13 of their participation; 3) Number of incontinence episodes; 4) Relationship of incontinence to urge or stress (4 grade scale); 4) Whether she used any pads.|2 months|Study prematurely stopped|||||
722069|NCT00323739|Secondary|Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death||18 months|||Months||95% Confidence Interval|Median
722070|NCT00323739|Primary|Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease||18 months|||Months||95% Confidence Interval|Median
722071|NCT00323869|Secondary|Overall Survival (OS) at 24 Months|Number of subjects surviving 2 years after treatment initiation|24 months|Includes all subjects who initiated treatment||participants|||Number
722072|NCT00323869|Secondary|Overall Survival (OS) at 12 Months|Number of subjects surviving 1 year after treatment initiation|12 months|Includes all subjects who initiated treatment||participants|||Number
722078|NCT00323869|Secondary|Response Rate (CR + PR + SD)|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions, by computed tomography (CT); bone scan; positron emission tomography (PET) scan; and/or magnetic resonance imaging (MRI) as necessary to assess diseasE
Response determined as the number of subjects with any clinical response (CR + PR + SD) per RECIST criteria.
Complete Response (CR) = disappearance of all target lesions
Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions
Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, or appearance of new cancer lesions
Stable Disease (SD): No significant effect, does not meet criteria for PR or PD."|6 weeks|Includes all subjects who initiated treatment||participants|||Number
722079|NCT00323869|Primary|Progression-free Survival (PFS)|Median progression-free survival (PFS) was assessed as the time to disease progression; toxicity requiring treatment discontinuation; or death.|18 months|Includes all subjects who initiated treatment||months||Full Range|Median
722080|NCT00323882|Secondary|Number of Participants Positive for Human Anti-Human Antibodies (HAHA) - Treated Participants|HAHA was measured by electrochemiluminescent (ECL) immunoassay for the detection of antibodies in human heparin plasma. Testing was performed on Days 1 (prior to ipilimumab infusion), 64, 85, and at completion of treatment.|Day 1 up to 2 years|All participants in the study who received either ipilimumab or radiation and had a measurement were analyzed.||participants|||Number
722081|NCT00323882|Secondary|Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities at Baseline and During Treatment Period - Treated Participants|12 Lead Electrocardiograms (ECGs) were performed at screening (Day -28 to Day -1), and on Day 85 during a treatment cycle, and at the end of treatment period. Clinically significant abnormalities could include atrial fibrillation, anterior fascicular block, marked sinus bradycardia, possible lateral infarct, and T-wave abnormality (other potential abnormalities were not excluded from consideration).|Baseline up to 2 years|All participants in the study who received either ipilimumab or radiation and had an ECG were analyzed.||participants|||Number
722082|NCT00323882|Secondary|Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants|CTC v3.0 used. On-study serum chemistry laboratories were reported after first dose date, every 21 days during a treatment cycle, and within 70 days of last dose of study therapy (ie, Days 1, 22, 43, 64, 85, etc). Alanine Aminotransferase (ALT) Units per Liter (U/L) Gr 1: > 1.0 - 2.5 * upper limits of normal (ULN); Gr 2: > 2.5 - 5.0 * ULN; Gr 3: > 5.0 - 20.0 * ULN; Gr 4: > 20.0 * ULN. Aspartate Aminotransferase (AST) U/L: Gr 1: > 1.0 - 2.5 * ULN; Gr 2: > 2.5 - 5.0 * ULN; Gr 3: > 5.0 - 20.0 * ULN; Gr 4: > 20.0 * ULN. Total Bilirubin micromoles per liter (µmol/L): Gr 1: > 1.0 - 1.5 * ULN; Gr 2: > 1.5 - 3.0 * ULN; Gr 3: > 3.0 - 10.0 * ULN; Gr 4: > 10.0 * ULN. Alkaline Phosphatase U/L: Gr 1: > 1.0 - 2.5 * ULN; Gr 2: > 2.5 - 5.0 * ULN; Gr 3: > 5.0 - 20.0 * ULN; Gr 4: > 20.0 * ULN. Amylase U/L: Gr1: > 1.0 - 1.5 * ULN; Gr 2: > 1.5 - 2.0 * ULN; Gr 3: > 2.0 - 5.0 * ULN; Gr4: > 5.0 * ULN. Creatinine µmol/L: Gr1: > 1.0 - 1.5*ULN; Gr2: > 1.5 - 3.0*ULN; Gr3: > 3.0 - 6.0*ULN; Gr4: > 6.0*ULN.|Day 1 to last day of study treatment (+70 days) up to 2 years|All participants in the study who received either ipilimumab or radiation and had a laboratory measurement were analyzed.||participants|||Number
722083|NCT00323882|Secondary|Number of Participants With On-Study Hematology Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants|NCI CTC version(v) 3.0 was used to determine Grade (Gr). Screening was Day -28 to Day -1. On-study laboratories were reported after the first dose date, every 21 days during a treatment cycle, and within 70 days of last dose of study therapy (ie, Days 1, 22, 43, 64, 85, etc). Hemoglobin grams per liter (g/L): Gr 1: 10.0 - less than (<) lower limit of normal (LLN); Gr 2: 8.0 - < 10.0; Gr 3: 6.5 - < 8.0; Gr 4: < 6.5. White blood cells(WBC) 10^9 cells per liter (c/L): Gr1: 3.0 - < LLN; Gr 2: 2.0 - < 3.0; Gr 3: 1.0 - < 2.0; Gr4: < 1.0. Lymphocytes (absolute) 10^9 c/L: Gr1: 0.8 - < 1.5; Gr 2: 0.5 - < 0.8; Gr 3): 0.2 - < 0.5; Gr 4: < 0.2. Neutrophils (absolute) 10^9 c/L: Gr 1: 1.5 - < 2.0; Gr 2: 1.0 - < 1.5; Gr 3: 0.5 - < 1.0; Gr 4: < 0.5. Platelets 10^9 c/L: Gr 1: 75.0 - < lower limits of normal (LLN); Gr 2: 50.0 - < 75.0; Gr 3: 25.0 - < 50.0; Gr 4: < 25.0.|Day 1 to last day of study treatment (+70 days) up to 2 years|All participants in the study who received either ipilimumab or radiation and had a laboratory measurement were analyzed.||participants|||Number
722084|NCT00323882|Secondary|Overall Survival at Completion of Follow Up Period - Treated Participants|Overall Survival (OS) was defined as the time from the first date of study treatment until the date of death and was measured in months. For those participants who have not died, OS was censored at the last date the participant was known to be alive. Completion of follow-up for OS was a minimum time of eligibility 54 months to a maximum of 85 months.|Day 1 to 5 years post treatment|All participants in cohorts with monotherapy and with radiotherapy who received any ipilimumab were analyzed.||Months||95% Confidence Interval|Median
722085|NCT00323882|Secondary|Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants|Primary analysis was conducted on data from Day 1 up to 2 years post treatment, data available as of September 2009. Final Follow-Up analysis was conducted on data up to 5 years post treatment, data available as of September 2013 (minimum time of eligibility 54 months to a maximum of 85 months). Primary causes of deaths are listed under each timepoint.|Day 1 to 5 years post treatment|Treated participants population included all participants in the study who received either ipilimumab or radiation.||participants|||Number
722086|NCT00323882|Primary|Number of Participants With Best PSA Response at Day 85 by Category - PSA Evaluable Participants|Response by investigator using National Cancer Institute (NCI) PSA Working Group recommendations= PSA < 50% of PSA reference value occurring on or before Day 85; response confirmed at least 4 weeks after the first measurement. PSA reference=PSA measured immediately prior to treatment. Complete response (CR)=PSA < 2 nanograms per milliliter (ng/mL), confirmed at least 4 weeks after 1st value; Partial response (PR)=PSA ≤ 50% of PSA reference, confirmed at least 4 weeks after 1st value; Unconfirmed=not confirmed by repeat measurements; Stable disease(SD)=No change from PSA reference; Progressive disease (PD) defined: If PSA nadir was ≥ 100% of the reference: PSA ≥ 125% of PSA reference and with a difference of absolute value of ≥ 5 ng/mL; If PSA nadir was < 100% and ≥ 50% of the reference: PSA ≥ 125% of PSA nadir and with a difference of absolute value of ≥ 5 ng/mL: If PSA nadir was < 50% of the reference: PSA ≥ 150% of PSA nadir and with a difference of absolute value of ≥ 5 ng/mL.|Day 85|PSA-evaluable participants, including all participants in cohorts with monotherapy and with radiotherapy who received any ipilimumab and had a baseline PSA, were analyzed.||participants|||Number
722087|NCT00323882|Secondary|PSA Response Rate at Day 85 and Overall PSA Response Rate in 10 mg/kg Monotherapy and Combination Therapy|PSA response rate was defined as the number of participants with a PSA response (PR or CR) divided by the total number of PSA evaluable participants. PSA response at Day 85, as reported by the investigator, was defined as a PSA concentration < 50% of the PSA reference value occurring on or before Day 85 and this response was confirmed at least 4 weeks after the first determination. The PSA reference value was the PSA concentration measured immediately prior to treatment. Overall Response is < 50% of the PSA reference value occurring anytime after treatment was initiated and this response was confirmed at least 4 weeks after the first determination. Complete response=PSA concentration < 2 ng/mL, confirmed at least 4 weeks after first value; Partial response=PSA concentration ≤ 50% of PSA reference value, confirmed at least 4 weeks after first determination.|Day 85, Day 1 to last day of study treatment (+70 days) up to 2 years|All participants in cohorts with 10 mg/kg ipilimumab monotherapy and with 10 mg/kg ipilimumab combination therapy with XRT who received any ipilimumab and had a baseline PSA, were analyzed.||percentage of participants||95% Confidence Interval|Number
722088|NCT00323882|Secondary|Overall Tumor Response Rate in 10 mg/kg Ipilimumab Monotherapy and Ipilimumab/XRT Combination Therapy|Tumor response rate was defined as the number of participants with a best response of partial or complete response divided by the total number of tumor evaluable participants. Overall Tumor Response was defined as participants with a tumor response of CR or PR at anytime during the study. CR=Disappearance of all target lesions; PR=At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference, baseline sum LD. For a status of CR or PR, changes in tumor measurements were confirmed by repeat studies no less than 4 weeks after the criteria for response were first met|Day 1 to last day of study treatment (+70 days) up to 2 years|All participants in cohorts with 10 mg/kg ipilimumab monotherapy and with 10 mg/kg ipilimumab combination therapy with XRT who received any ipilimumab and had a baseline PSA, were analyzed.||percentage of participants||95% Confidence Interval|Number
722089|NCT00323882|Secondary|Time to PSA Response at Day 85 in Participants With Complete Response (CR) or Confirmed Partial Response (PR) at Day 85|Time to PSA response was measured in months. Time to PSA response was analyzed in those participants with CR or PR at Day 85. CR=PSA concentration < 2 ng/mL, confirmed at least 4 weeks after 1st value; PR=PSA concentration ≤ 50% of PSA reference, confirmed at least 4 weeks after 1st value.|Day 1 to Day 85|All participants in cohorts with monotherapy and with radiotherapy who received any ipilimumab, had a baseline PSA, and had a confirmed Complete Response (CR) or Partial Response (PR) at Day 85.||Months||Full Range|Median
722090|NCT00323882|Secondary|Number of Participants With Best Overall Tumor Response by Category - Tumor Evaluable Participants|For those with measurable disease, tumor response based upon tumor lesions (per investigator) using Response Evaluation Criteria in Solid Tumors (RECIST). Best Overall=Participants with a best tumor response of CR or PR at anytime during the study. CR=Disappearance of all target lesions; PR=At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference, baseline sum LD. For a status of CR or PR, changes in tumor measurements were confirmed by repeat studies no less than 4 weeks after the criteria for response were first met; Unconfirmed=not confirmed by repeat measurements; SD=Neither sufficient decrease to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started; PD=At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Day 1 to last day of study treatment (+70 days) up to 2 years|Tumor-evaluable participants, including all participants in cohorts with monotherapy and with radiotherapy who received any ipilimumab and had measurable disease at baseline, were analyzed.||participants|||Number
722091|NCT00323882|Secondary|Number of Participants With Best Overall PSA Response by Category - PSA Evaluable Participants|Best Overall PSA response per investigator, using NCI PSA Working Group: PSA with CR or PR at any time after treatment initiation and was confirmed at least 4 weeks after the first measurement. PSA reference=PSA measured immediately prior to treatment. CR=PSA concentration < 2 nanograms per milliliter (ng/mL), confirmed at least 4 weeks after 1st value; PR=PSA concentration ≤ 50% of PSA reference, confirmed at least 4 weeks after 1st value; Unconfirmed=not confirmed by repeat measurements; SD=No change from PSA reference value; PD = If PSA nadir was ≥ 100% of the reference value: PSA ≥ 125% of PSA reference and with a difference of absolute value of ≥ 5 ng/mL; If PSA nadir was < 100% and ≥ 50% of the reference value: PSA ≥ 125% of PSA nadir and with a difference of absolute value of ≥ 5 ng/mL: If PSA nadir was < 50% of the reference value: PSA ≥ 150% of PSA nadir and with a difference of absolute value of ≥ 5 ng/mL.|Day 1 to last day of study treatment (+70 days) up to 2 years|PSA-evaluable participants, including all participants in cohorts with monotherapy and with radiotherapy who received any ipilimumab and had a baseline PSA, were analyzed.||participants|||Number
722092|NCT00323882|Primary|Number of Participants With Serious AEs (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs - Treated Participants|AEs graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling, Gr 5=Death. Related=relationship to study drug reported as certain, probable, possible, or missing. Immune-related AE (irAE) was defined as a clinically significant AE of any organ that is associated with drug exposure, of unknown etiology, and is consistent with an immune-mediated mechanism. Day 1=first day of study treatment.|Day 1 to last day of study treatment (+70 days) up to 2 years|All participants in the study who received either ipilimumab or radiation were analyzed.||participants|||Number
722093|NCT00324038|Primary|Average Daily Pain Scores - BS11 Pain Scores.|The primary efficacy variable was the average daily pain score recorded on a Box Scale-11 pain scale in the evening. 0 = no pain and 10 = most pain imaginable. Subjects ticked the box from 0 - 10 which best describes their level of pain.|every day over a 12 week study duration.|||Box Scale 11 boxes||Standard Deviation|Mean
722119|NCT00324168|Secondary|Best Spectacle-corrected Visual Acuity (BSCVA) in logMAR at 12 Months, Using Best Spectacle-corrected Enrollment Visual Acuity as a Co-variate|LogMAR (logarithm of the Minimum Angle of Resolution) is a measure of visual acuity in which the smaller values indicate better visual acuity.|12 months from enrollment|||logMAR||95% Confidence Interval|Mean
722094|NCT00324116|Secondary|Change in Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ 25).|Patient reported vision-related functioning and quality of life as measured using the 25 item NEI-VFQ 25. Change = Mean score at 54 weeks - mean score at baseline. A positive change represents an increase in function/health from Baseline. Items grouped as the following - Composite: mean score items 1-25; General Health: item 1; General Vision: item 2; Ocular Pain:4,19; Near Vision:5,6,7; Distance Vision:8,9,14; Social Functioning:11,13; Mental Health Activities:3,21,22,25; Role Difficulties:17,18; Dependency:20,23,24; Driving:15c,16, 16a; Color Vision: 12; Peripheral Vision: 10.|Baseline, 54 weeks or at early termination|FAS; n=number of subjects with evaluable data.||score on scale||Standard Deviation|Mean
722095|NCT00324116|Secondary|Number of Subjects With a Distance Visual Acuity of > 20/200 at Baseline and Progressing to (<= 20/200)|"Subjects with improving scores are those with > 20/200 at Baseline and progressing to =< 20/200 at Week 54.
Subjects with no change are those with > 20/200 at Baseline and remaining at > 20/200 at Week 54."|54 weeks|FAS; n=77 (number of Subjects at Baseline with >20/200 Visual Acuity)||participants|||Number
722096|NCT00324116|Secondary|Number of Subjects With Severe Visual Loss|Subjects with severe visual loss: loss from baseline of >= 30 letters of visual acuity. Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0.|54 weeks or at early termination|FAS||participants|||Number
722097|NCT00324116|Secondary|Number of Subjects Maintaining Vision|Subjects maintaining vision: gain from baseline of more than 0 letters of visual acuity. Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0.|54 weeks or at early termination|FAS||participants|||Number
722098|NCT00324116|Secondary|Number of Subjects Gaining Vision|Subjects gaining vision: gain from baseline of more than 15 letters of visual acuity. Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0.|54 weeks or at early termination|FAS||participant|||Number
722099|NCT00324116|Secondary|Change From Baseline in Visual Acuity|Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0. Change: mean score at observation minus mean score at baseline.|Baseline, 6 weeks, 12 weeks, 54 weeks|FAS; n=number of subjects with evaluable data.||score on scale||Standard Deviation|Mean
722100|NCT00324116|Primary|Number of Responders for Visual Acuity Using Early Treatment Diabetic Retinopathy Study (ETDRS)|Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0. Responders defined as subjects having lost from baseline less than 15 letters of the best-corrected visual acuity; includes subjects with visual acuity gain.|Baseline, 54 Weeks|The full analysis set (FAS) was derived from the set of all enrolled subjects who 1) were administered the study medication AND 2) had post-baseline documentation of efficacy available. In the case of missing data post-baseline, the subject was considered censored at the time of the last available data for the score.||participants|||Number
722120|NCT00324168|Secondary|Ocular Perforations||At the time of perforation|||participants|||Number
722121|NCT00324168|Secondary|Time to Resolution of Epithelial Defect|This outcome measured time from enrollment to resolution of the epithelial defect in days for up to 21 days. For three weeks patients were examined every 3 days for size of epithelial defect until the defect was gone.|From enrollment up to 21 days|||days||Standard Deviation|Mean
722122|NCT00324168|Secondary|Best Hard Contact Lens Corrected Visual Acuity Measured in logMAR, Correcting for Best Spectacle Corrected Visual Acuity at Enrollment|LogMAR (logarithm of the Minimum Angle of Resolution) is a measure of visual acuity in which the smaller values indicate better visual acuity.|3 months from enrollment|||logMAR||95% Confidence Interval|Mean
722123|NCT00324168|Secondary|Infiltrate/Scar Size, Correcting for Infiltrate/Scar Size at Enrollment||3 months from enrollment|||mm||95% Confidence Interval|Mean
722124|NCT00324168|Primary|Best Spectacle-corrected Visual Acuity (BSCVA) in logMAR at 3 Months, Using Best Spectacle-corrected Enrollment Visual Acuity as a Co-variate|LogMAR (logarithm of the Minimum Angle of Resolution) is a measure of visual acuity in which the smaller values indicate better visual acuity.|3 months from enrollment|||logMAR||95% Confidence Interval|Mean
722125|NCT00307294|Secondary|Tolerance/Safety||4 weeks||||||
722126|NCT00307294|Secondary|Overall Survival||36 months||||||
722127|NCT00307294|Secondary|Clinical Response Rate||4 weeks||||||
722114|NCT00324168|Secondary|Subgroup Analysis Predicting Best Spectacle-corrected Visual Acuity (BSCVA) as Stratified by Categories of Infiltrate/Scar Size|Best-spectacle visual acuity (BSCVA) at 3 months from enrollment is stratified by categories of infiltrate/scar size and examined by treatment arm|3 months from enrollment|||logMAR||Standard Deviation|Mean
722115|NCT00324168|Secondary|Subgroup Analysis of Best Spectacle-corrected Visual Acuity (BSCVA) by Categories of Infiltrate Depth|BSCVA measured in logMAR will be examined by categories infiltrate depth (categorized by depth percentage) by mean and standard deviation as well as in a regression model.|3 months from enrollment|||logMAR||Standard Deviation|Mean
722116|NCT00324168|Secondary|Subgroup Analysis Predicting 3 Month Best Spectacle-corrected Visual Acuity (BSCVA) by Visual Acuity Group|Best spectacle-corrected visual acuity (BSCVA) for this subgroup analysis was measured in logMAR and then categorized by equivalent Snellen fractions|3 months from enrollment|||logMAR||Standard Deviation|Mean
722117|NCT00324168|Secondary|Subgroup Analysis Predicting 3 Month Best Spectacle-corrected Visual Acuity (BSCVA) by Causative Organism|BSCVA measured in logMAR will be estimated by causative organism (either Nocardia spp, Streptococcus pneumoniae, Moraxella spp, or Pseudomonas aeruginosa). BSCVA will be examined for each causative organism by mean and standard deviation as well as in a regression model.|3 months after enrollment|||logMAR||Standard Deviation|Mean
722118|NCT00324168|Secondary|Best Spectacle-corrected Visual Acuity (BSCVA) in logMAR Using MIC (Minimum Inhibitory Concentration) to Moxifloxacin as a Covariate|Best spectacle-corrected visual acuity (BSCVA) for this outcome is measured in logMAR (logarithm of the Minimum Angle of Resolution) in which smaller values indicate better visual acuity. Minimum inhibitory concentration (MIC) to moxifloxacin was measured by E test and a log2-transformation of MIC was used in all analyses. In this analysis we add MIC to the model examining BSCVA at 3 months.|3 months after enrollment|The study population analyzed for this outcome includes only those study subjects for whom an MIC value was available.||logMAR||95% Confidence Interval|Mean
722133|NCT00307437|Secondary|Number of Participants Visits With Psoriasis Area and Severity Index (PASI) 75 From Week 40 Through Week 52|Number of visits at which participants randomized at Week 28 achieved at least 75 percent improvement from baseline in PASI from Week 40 through Week 52 in participants randomized at Week 28. PASI is a widely used tool for the measurement of severity of psoriasis. This is a test of how bad a person's psoriasis is. The scale combines redness, scaling, and thickness, as well as overall body involvement to determine the PASI score. The scale ranges from 0 (best) to 72 (worst).|Week 40 to Week 52|All participants randomized at Week 28 were included in the analysis according to the assigned treatment groups. Participant is considered a non- responder if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy.||Participants||Inter-Quartile Range|Median
722134|NCT00307437|Secondary|Change in Dermatology Life Quality Index (DLQI) at Week 12|Change in Dermatology Life Quality Index (DLQI) from baseline at Week 12. The DLQI is a 10-item questionnaire, that in addition to evaluating overall quality of life, can be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Scores range from 0 (no impairment in quality of life) to 30 (most impairment in quality of life).|Baseline to Week 12|Participants were included in the analysis according to the assigned treatment groups. Zero change is imputed if the partcipant has used any pre-specified prohibited medications or discontinued due to lack of efficacy. Other missing data were not imputed.||Units on a scale||Inter-Quartile Range|Median
722135|NCT00307437|Secondary|Number of Participants With Physician Global Assessment (PGA) of Cleared or Minimal at Week 12|Number of participants achieving a physician global assessment (PGA) (0 [none] to 5 [severe]) of cleared or minimal at Week 12. The PGA is 7-point scale used in clinical trials of various diseases. In this the physician checks the state of the disease and gives them score from 0 (clear) to 5 (severe).|Week 12|Intent to treat. All participants were included in the analysis according to the assigned treatment groups. Participant is considered a non- responder if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy or had missing data at Week 12.||Participants|||Number
722136|NCT00307437|Primary|Number of Participants With Psoriasis Area and Severity Index (PASI) Score of 75 Percent or Above at Week 12|Number of participants achieving greater than or equal to 75 percent improvement in PASI at Week 12. PASI is a widely used tool for the measurement of severity of psoriasis. This is a test of how bad a person's psoriasis is. The scale combines redness, scaling, and thickness, as well as overall body involvement to determine the PASI score. The scale ranges from 0 (best) to 72 (worst).|Week 0 to Week 12|Intent to treat. All participants randomized were included in the analysis according to the assigned treatment groups. Participant is considered a non- responder if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy or had missing data at Week 12.||Participants|||Number
722137|NCT00307489|Secondary|Percentage of Participants With Plasma HBV DNA < 169 Copies/mL at Week 168|P-values were from a Cochran-Mantel-Haenszel test, controlling for baseline HBeAg status and prior lamivudine use.|168 weeks|Non-completers = failure analysis||Percent of Participants|||Number
722138|NCT00307489|Secondary|HBsAg Loss at Week 168|Defined as having negative serum HBsAg for subjects with positive HBsAg at baseline.|168 weeks|||Participants|||Number
722139|NCT00307489|Secondary|Hepatitis B Surface Antigen (HBsAg) Seroconversion at Week 168|Defined as having negative serum BHsAg and positive serum antibody to HBsAg (anti-HBs) for subject with positive serum BHsAg at baseline.|168 weeks|Non-completer = Failure Analysis||Participants|||Number
722140|NCT00307489|Secondary|Hepatitis B Early Antigen (HBeAg) Loss at Week 168|Defined as having negative serum HBeAg for subjecst with positive HBeAg at baseline.|168 weeks|Non-completer = Failure Analysis||Percent of Participants|||Number
722141|NCT00307489|Secondary|Percentage of Participants With Normalized ALT at Week 168|Subjects with elevated ALT at baseline that return to normal by Week 48.|168 weeks|||Percent of Participants|||Number
722142|NCT00307489|Secondary|Percentage of Participants With Normal ALT at Week 168|ULN for males = 43 U/L; ULN for females = 34 U/L|168 weeks|Non-completers = failure analysis||Percent of Participants|||Number
722143|NCT00307489|Secondary|Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 168||168 weeks|Non-completers = failure analysis||Percent of Participants|||Number
722144|NCT00307489|Secondary|Change From Baseline in Alanine Aminotransferase (ALT) Levels at Week 168||168 weeks|Non-completers = failure analysis||U/mL||Standard Deviation|Mean
722145|NCT00307489|Secondary|Change From Baseline in log10 Plasma HBV DNA Levels at Week 168||168 weeks|Non-completers = failure analysis||log10 copies/mL||Standard Deviation|Mean
722146|NCT00307489|Secondary|Hepatitis B Surface Antigen (HBsAg) Seroconversion at Week 48|Defined as having negative serum HBsAg and positive serum antibody to HBsAg [anti-HBs] for subject with positive serum HBsAg at baseline.|48 Weeks|RAT Analysis Set Non-Completers=Failure||participants|||Number
722147|NCT00307489|Secondary|HBsAg Loss at Week 48|Defined as having negative serum HBsAg for subjects with positive HBsAg at baseline.|48 Weeks|RAT Analysis Set Non-Completers=Failure||participants|||Number
722148|NCT00307489|Secondary|HBeAg Seroconversion at Week 48|Defined as having negative serum HBeAg and positive serum antibody to HBeAg [anti-HBe] for subjects with positive serum HBeAg at baseline.|48 Weeks|RAT Analysis Set with Positive Baseline HBeAg. Non-Completers=Failure||participants|||Number
722149|NCT00307489|Secondary|Hepatitis B Early Antigen (HBeAg) Loss at Week 48|Defined as having negative serum HBeAg for subjects with positive HBeAg at baseline.|48 Weeks|RAT Analysis Set with Positive HBeAg at Baseline. Non-Completers=Failure||participants|||Number
722150|NCT00307489|Secondary|Percentage of Participants With Normalized ALT at Week 48|Subjects with elevated ALT at baseline that return to normal by Week 48.|48 Weeks|RAT Analysis Set - subjects with ALT above ULN at baseline. Non-Completers=Failure||percentage of participants|||Number
722151|NCT00307489|Secondary|Percentage of Participants With Normal ALT at Week 48|ULN for males = 43 U/L; 34 U/L for females|48 Weeks|RAT Analysis Set Non-Completers=Failure||percentage of participants|||Number
722152|NCT00307489|Primary|Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 48||48 Weeks|RAT Analysis Set Non-Completers=Failure||percentage of participants|||Number
722153|NCT00307489|Secondary|Change From Baseline in Alanine Aminotransferase (ALT) Levels at Week 48||48 Weeks|RAT Analysis Set||U/mL||Standard Deviation|Mean
722154|NCT00307489|Secondary|Change From Baseline in log10 Plasma HBV DNA Levels at Week 48||48 Weeks|RAT Analysis Set||log10 copies/mL||Standard Deviation|Mean
722157|NCT00307684|Secondary|Change From DB Baseline to DB Endpoint in CGI-S Score|evaluation of treatment effects as rated by the investigator on the CGI-S scale. CGI-S is used to rate the severity of a subject’s illness on a 7- point scale ranging from 1 (not ill) to 7 (extremely severe).|DB baseline, DB endpoint|Intent to treat: all subjects who used study medication at least once||units on a scale||Standard Deviation|Mean
722158|NCT00307684|Secondary|Change From OL Baseline in Quality of Life, Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Score at OL Endpoint|Quality of life measured by Q-LES-Q best score: 100 worst score: 0|OL baseline, OL endpoint|intent to treat: all subjects who used trial medication at least once||units on a scale||Standard Deviation|Mean
722159|NCT00307684|Secondary|Change From OL Baseline in Clinical Global Impression Scale (CGI-S) Score at OL Endpoint|Assessment of the long term effect on overall functioning measured by CGI-S best score: 1 worst score: 7|OL baseline, OL endpoint|intent to treat: all subjects who used trial medication at least once||units on a scale||Standard Deviation|Mean
722160|NCT00307684|Primary|Change From DB Baseline in Conners' Adult ADHD Rating Scale (CAARS) Total Score at DB Endpoint|"To evaluate maintenance of treatment effects of PR OROS MPH vs. placebo as measured on CAARS.
CAARS assesses ADHD symptoms and behaviors in adults. best value: 0 worst value: 54
Endpoint: last available post-baseline assessment."|DB baseline, DB endpoint|intent to treat: all subjects who used trial medication at least once||units on a scale||Standard Deviation|Mean
722161|NCT00307684|Secondary|Change From OL Baseline to OL Endpoint in Conners' Adult ADHD Rating Scale (CAARS) Total and Subscale Scores|"Long term efficacy of PR OROS MPH as assessed by investigator-rated CAARS total score, hyperactivity/impulsivity subscale score and inattention subscale score.
Subscale scores: best value: 0, worst value: 27"|OL baseline, OL endpoint|intent to treat: all subjects who used trial medication at least once||units on a scale||Standard Deviation|Mean
722162|NCT00307684|Primary|Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs)|To evaluate the long term safety and tolerability of PR OROS MPH (18, 36, 54, 72 and 90 mg/day) in adults with Attention Deficit Hyperactivity Disorder (ADHD)|Treatment duration for OL extended from 52 wks to 72 wks (International Amendment 2) or 108 wks in Germany. Treatment duration for double-blind (DB) randomized withdrawal: 4 weeks|intent-to-treat: all subjects who used the study medication at least once||participants|||Number
722163|NCT00307736|Other Pre-specified|Pathologic Complete Response|The number of subjects who achieved a pathologic complete response as determine by pathologist, following completion of the study therapy. Pathologic complete response represents the absence of residual invasive disease in the rectum and in the regional lymph nodes.|3 years|Patients who completed study therapy.||Participants|||Count of Participants
722164|NCT00307736|Secondary|Post-operative Complications After Resection of Rectal Cancers Following Preoperative 5-FU, Bevacizumab, Erlotinib, and External Beam Radiation Therapy.|Surgical morbidity following R0 resection with one of the following procedures: abdominal perineal resection, low anterior resection, and low anterior resection with coloanal anastomosis.|3 years|Total study population excluding one patient who refused surgery.||participants|||Number
722165|NCT00307736|Secondary|Percentage of Participants With Disease-free Survival|Summary of disease free survival at 1, 2, and 3 years. Disease free survival is the length of time after primary treatment for cancer ends that the participant survives without any clinical signs or symptoms of that cancer. The data is shown of the percentage of participants still in disease free survival at one, two, and three years.|1, 2, 3 years|||percentage of participants||95% Confidence Interval|Number
722166|NCT00307736|Secondary|Summary of Grade 3 or Greater Toxicity|"Summary of grade 3 or greater toxicity by grade and type. All adverse events were evaluated using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Grade 3: Severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living.
Grade 4 Life-threatening consequences; urgent intervention indicated."|3 years|Toxicity was grouped together for all phase I dose cohorts and the phase II cohort in order to summarize all the grade 3 or greater toxicities associated with the combined study therapy, instead of focusing on the dose limiting toxicities from the phase 1 dose escalation of Erlotinib. Grade 3 or higher AE data is not available by dose cohort.||participants|||Number
722167|NCT00307736|Primary|Maximum Tolerated Dose (MTD) of Erlotinib When Administered in Combination With 5-fluorouracil (5-FU), Bevacizumab, and External Beam Radiation Therapy|MTD of Erlotinib was determined using a traditional 3 + 3 dose escalation scheme of three dose levels (50,100,150mg). Successive cohorts of 3-6 patients were enrolled into dose escalation cohorts for 14 day cycles. MTD reflects the highest dose of Erlotinib that had ≤1 out of 6 patients with Dose-Limiting Toxicity (DLT) at the highest dose level below the maximally administered dose. The maximally administered dose is the first dose that causes DLT in >33% of patients. DLT was defined as: Any grade 4 neutropenia, Any grade 3 thrombocytopenia, or Any ≥ grade 3 non-hematologic toxicity that results in greater than 7 days interruption in therapy.|3 years|||mg|||Number
722168|NCT00307801|Post-Hoc|Change in Absolute Value From Baseline Menstrual Blood Loss (MBL) to end-of Study MBL|The MBL for each cycle includes intermenstrual bleeding in addition to withdrawal bleeding. Baseline MBL was the mean MBL of measured MBL during three cycles in the run-in Phase. One cycle was defined as 28 days. For this analysis, the run-in Phase was defined by the days 1 to 84 (= 3 cycles each of 28 days). End of Study MBL was measured during Cycle 7 of the Treatment Phase (data imputation and Last Observation Carried Forward was applied).|during a time period of 28 days under treatment|Only participants with heavy menstrual bleeding were included in the analysis.||mL||Standard Deviation|Mean
722169|NCT00307801|Post-Hoc|Proportion of Participants With Successful Treatment|End of Study menstrual blood loss (MBL) ≤ 80 mL and a decrease to a value of ≤ 50% of the Baseline MBL was considered as treatment success.|during a time period of 28 days under treatment|Only participants with heavy menstrual bleeding were included in the analysis.||Proportion of participants|||Number
722170|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Not Have Any Medical Treatment） at Treatment Day 196|The patient was asked if she had any medical treatment (eg, prescribed medication, other treatment) because of her DUB during the past 12 weeks, and to specify the cost. The proportion of participants with such treatment are displayed.|Treatment day 196|ITT, all participants with assessment at treatment day 196 for this outcome measure||Proportion of participants|||Number
722171|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Not Have Any Medical Treatment） at Treatment Day 84|The patient was asked if she had any medical treatment (eg, prescribed medication, other treatment) because of her DUB during the past 12 weeks, and to specify the cost. The proportion of participants with such treatment are displayed.|Treatment day 84|ITT, all participants with assessment at treatment day 84 for this outcome measure||Proportion of participants|||Number
722172|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （no Out-of-pocket Expenses） at Treatment Day 196|The patient was asked to specify her out-of pocket expenses because of her DUB during the past 12 weeks, including over-the-counter medication (the name of the medication, the number of packages, and the cost per package), co-payments due to prescribed medication, and costs to travel to and from medical appointments. The proportion of participants with no out-of pocket expenses are displayed.|Treatment day 196|ITT, all participants with assessment at treatment day 196 for this outcome measure||Proportion of participants|||Number
722173|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （no Out-of-pocket Expenses） at Treatment Day 84|The patient was asked to specify her out-of pocket expenses because of her DUB during the past 12 weeks, including over-the-counter medication (the name of the medication, the number of packages, and the cost per package), co-payments due to prescribed medication, and costs to travel to and from medical appointments. The proportion of participants with no out-of pocket expenses are displayed.|Treatment day 84|ITT, all participants with assessment at treatment day 84 for this outcome measure||Proportion of participants|||Number
722174|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Received Ambulatory Services） at Treatment Day 196|The patient was asked if she received ambulatory services (eg, home help, child care) because of her DUB during the past 12 weeks, and if yes, how many hours per week. The proportion of participants with such services are displayed.|Treatment day 196|ITT, all participants with assessment at treatment day 196 for this outcome measure||Proportion of participants|||Number
722175|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Received Ambulatory Services） at Treatment Day 84|The patient was asked if she received ambulatory services (eg, home help, child care) because of her DUB during the past 12 weeks, and if yes, how many hours per week. The proportion of participants with such services are displayed.|Treatment day 84|ITT, all participants with assessment at treatment day 84 for this outcome measure||Proportion of participants|||Number
722176|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Additional Unscheduled Procedures） at Treatment Day 196|The patient was asked if she had any unscheduled procedures (eg, laparoscopy, laboratory tests, ultrasound) because of her DUB during the past 12 weeks. The proportion of participants with such procedures are displayed.|Treatment day 196|ITT, all participants with assessment at treatment day 196 for this outcome measure||Proportion of participants|||Number
722177|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Additional Unscheduled Procedures） at Treatment Day 84|The patient was asked if she had any unscheduled procedures (eg, laparoscopy, laboratory tests, ultrasound) because of her DUB during the past 12 weeks. The proportion of participants with such procedures are displayed.|Treatment day 84|ITT, all participants with assessment at treatment day 84 for this outcome measure||Proportion of participants|||Number
722178|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Unscheduled Outpatient Visit to Physician） at Treatment Day 196|The patient was asked if she had any unscheduled outpatient visits to a physician (non-hospital medical care) because of her DUB during the past 12 weeks, not including visits that were due to her participation in this study. She was also asked to indicate the number of visits. The proportion of participants with such visits are displayed.|Treatment day 196|ITT, all participants with assessment at treatment day 196 for this outcome measure||Proportion of participants|||Number
722179|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Unscheduled Outpatient Visit to Physician） at Treatment Day 84|The patient was asked if she had any unscheduled outpatient visits to a physician (non-hospital medical care) because of her DUB during the past 12 weeks, not including visits that were due to her participation in this study. She was also asked to indicate the number of visits. The proportion of participants with such visits are displayed.|Treatment day 84|ITT, all participants with assessment at treatment day 84 for this outcome measure||Proportion of participants|||Number
722180|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Unscheduled Outpatient Visit at Hospital） at Treatment Day 196|The patient was asked if she had any unscheduled outpatient visits to a hospital because of her DUB during the past 12 weeks, not including visits that were due to her participation in this study. She was also asked to indicate the number of visits. The proportion of participants with any unscheduled outpatient visits are displayed.|Treatment day 196|ITT, all participants with assessment at treatment day 196 for this outcome measure||Proportion of participants|||Number
722181|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Unscheduled Outpatient Visit at Hospital） at Treatment Day 84|The patient was asked if she had any unscheduled outpatient visits to a hospital because of her DUB during the past 12 weeks, not including visits that were due to her participation in this study. She was also asked to indicate the number of visits. The proportion of participants with any unscheduled outpatient visits are displayed.|Treatment day 84|ITT, all participants with assessment at treatment day 84 for this outcome measure||Proportion of participants|||Number
722182|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Regular Daily Activities） at Treatment Day 196.|The patient was asked to rate on a scale of 0 to 10, how much her DUB affected her ability to do her regular daily activities, other than work at a job, during the past 12 weeks, where 0 represented that her DUB had no effect on her daily activities and 10 represented that her DUB completely prevented her from doing her daily activities.|Treatment day 196|ITT, all participants with assessment at treatment day 196 for this outcome measure||Scores on a scale||Standard Deviation|Mean
722268|NCT00315120|Secondary|Medical Outcomes Study SF-36 Health Survey (OMT and Sham OMT - Week 12)|The general health scale ranges from 0 to 100, with higher scores representing better general health.|12 weeks|||SF-36 General Health Score||Inter-Quartile Range|Median
722183|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Regular Daily Activities） at Treatment Day 84|The patient was asked to rate on a scale of 0 to 10, how much her DUB affected her ability to do her regular daily activities, other than work at a job, during the past 12 weeks, where 0 represented that her DUB had no effect on her daily activities and 10 represented that her DUB completely prevented her from doing her daily activities.|Treatment day 84|ITT, all participants with assessment at treatment day 84 for this outcome measure||Scores on a scale||Standard Deviation|Mean
722184|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Productivity While Working） at Treatment Day 196.|The patient was asked to rate on a scale of 0 to 10, how much her DUB affected her productivity while she was working during the past 12 weeks, where 0 represented that her DUB had no effect on her work and 10 represented that her DUB completely prevented her from working.|Treatment day 196|ITT, all participants with assessment at treatment day 196 for this outcome measure||Scores on a scale||Standard Deviation|Mean
722185|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Productivity While Working） at Treatment Day 84.|The patient was asked to rate on a scale of 0 to 10, how much her DUB affected her productivity while she was working during the past 12 weeks, where 0 represented that her DUB had no effect on her work and 10 represented that her DUB completely prevented her from working.|Treatment day 84|ITT, all participants with assessment at treatment day 84 for this outcome measure||Scores on a scale||Standard Deviation|Mean
722186|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Days Missed From Work） at Treatment Day 196|The patient was asked how many days and hours she missed from work during the past 12 weeks because of her problems associated with her DUB, not including the time missed to participate in this study.|Treatment day 196|ITT, all participants with assessment at treatment day 196 for this outcome measure||days||Standard Deviation|Mean
722187|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Days Missed From Work） at Treatment Day 84|The patient was asked how many days and hours she missed from work during the past 12 weeks because of her problems associated with her DUB, not including the time missed to participate in this study.|Treatment day 84|ITT, all participants with assessment at treatment day 84 for this outcome measure||days||Standard Deviation|Mean
722188|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Change in the Employment Status） at Treatment Day 196.|The patient was asked if there was any change in her employment status in the last 12 weeks and was asked to specify the number of hours per week. The proportion of participants with such changes are displayed.|Treatment day 196|ITT, all participants with assessment at treatment day 196 for this outcome measure||Proportion of participants|||Number
722189|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Change in the Employment Status） at Treatment Day 84.|The patient was asked if there was any change in her employment status in the last 12 weeks and was asked to specify the number of hours per week. The proportion of participants with such changes are displayed.|Treatment day 84|ITT, all participants with assessment at treatment day 84 for this outcome measure||Proportion of participants|||Number
722190|NCT00307801|Secondary|Change From Baseline in Visual Analogue Scale (VAS) of the EQ-5D Score at Treatment Day 196.|"The visual analogue scale (ie, thermometer) had endpoints of 100 (best imaginable health state) at the top, and 0 (worst imaginable health state) at the bottom. Patients rated their current health state by drawing a line from the box marked your own health state today to the appropriate point on the thermometer scale."|Baseline (visit 5, day 1) and treatment day 196|ITT, all participants with assessments at baseline and treatment day 196 for this outcome measure||Scores on a scale||Standard Deviation|Mean
722191|NCT00307801|Secondary|Change From Baseline in Visual Analogue Scale (VAS) of the EQ-5D Score at Treatment Day 84.|"The visual analogue scale (ie, thermometer) had endpoints of 100 (best imaginable health state) at the top, and 0 (worst imaginable health state) at the bottom. Patients rated their current health state by drawing a line from the box marked your own health state today to the appropriate point on the thermometer scale."|Baseline (visit 5, day 1) and treatment day 84|ITT, all participants with assessments at baseline and treatment day 84 for this outcome measure||Scores on a scale||Standard Deviation|Mean
722192|NCT00307801|Secondary|Change From Baseline in EuroQol 5 Dimensional (EQ-5D) Score at Treatment Day 196|The health state classification of the EQ-5D comprises 5 questions addressing mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Patients were asked to indicate their current health state by ticking the most appropriate of 3 statements about each of the questions (ie, no problems, some problems, extreme problems). The best possible answers were (1,1,1,1,1), which equals a valuation score of 1.0. The worst possible answers were (3,3,3,3,3), which equals a score of .594.|Baseline (visit 5, day 1) and treatment day 196|ITT, all participants with assessments at baseline and treatment day 196 for this outcome measure||Scores on a scale||Standard Deviation|Mean
722193|NCT00307801|Secondary|Change From Baseline in EuroQol 5 Dimensional (EQ-5D) Score at Treatment Day 84|The health state classification of the EQ-5D comprises 5 questions addressing mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Patients were asked to indicate their current health state by ticking the most appropriate of 3 statements about each of the questions (ie, no problems, some problems, extreme problems). The best possible answers were (1,1,1,1,1), which equals a valuation score of 1.0. The worst possible answers were (3,3,3,3,3), which equals a score of .594.|Baseline (visit 5, day 1) and treatment day 84|ITT, all participants with assessments at baseline and treatment day 84 for this outcome measure||Scores on a scale||Standard Deviation|Mean
722194|NCT00307801|Secondary|Change From Baseline in McCoy Female Sexuality Questionnaire (MFSQ) Score at Treatment Day 196|The MFSQ was designed to measure aspects of female sexuality and asked about the patients´sexual experience during the last 4 weeks. Higher scores represent higher, more complete, or better integrated levels of female sexual function. Minimum and maximum values are 19 and 133.|Baseline (visit 5, day 1) and treatment day 196|ITT, all participants with assessments at baseline and treatment day 196 for this outcome measure||Scores on a scale||Standard Deviation|Mean
722269|NCT00315120|Secondary|Medical Outcomes Study SF-36 Health Survey (OMT and Sham OMT - Week 8)|The general health scale ranges from 0 to 100, with higher scores representing better general health.|8 weeks|||SF-36 General Health Score||Inter-Quartile Range|Median
722195|NCT00307801|Secondary|Change From Baseline in McCoy Female Sexuality Questionnaire (MFSQ) Score at Treatment Day 84|The MFSQ was designed to measure aspects of female sexuality and asked about the patients´sexual experience during the last 4 weeks. Higher scores represent higher, more complete, or better integrated levels of female sexual function. Minimum and maximum values are 19 and 133.|Baseline (visit 5, day 1) and treatment day 84|ITT, all participants with assessments at baseline and treatment day 84 for this outcome measure||Scores on a scale||Standard Deviation|Mean
722196|NCT00307801|Secondary|Change From Baseline in Psychological General Well-Being Index (PGWBI) Score at Treatment Day 196.|The PGWBI questionnaire consisted of 22 questions that were answered using a 6-grade Likert scale. The minimum overall score was 22 and the maximum 132. The higher the score, the better the well-being of the patient. The observation phase was the last 4 weeks. The following 6 dimensions were derived from the questionnaire: anxiety, depressed mood, positive well-being, self-control, health, and vitality and the highest possible scores were 30, 18, 24, 18, 18, and 24, respectively.|Baseline (visit 5, day 1) and treatment day 196|ITT, all participants with assessments at baseline and treatment day 196 for this outcome measure||Scores on a scale||Standard Deviation|Mean
722197|NCT00307801|Secondary|Change From Baseline in Psychological General Well-Being Index (PGWBI) Score at Treatment Day 84.|The PGWBI questionnaire consisted of 22 questions that were answered using a 6-grade Likert scale. The minimum overall score was 22 and the maximum 132. The higher the score, the better the well-being of the patient. The observation phase was the last 4 weeks. The following 6 dimensions were derived from the questionnaire: anxiety, depressed mood, positive well-being, self-control, health, and vitality and the highest possible scores were 30, 18, 24, 18, 18, and 24, respectively.|Baseline (visit 5, day 1) and treatment day 84|ITT, all participants with assessments at baseline and treatment day 84 for this outcome measure||Scores on a scale||Standard Deviation|Mean
722198|NCT00307801|Secondary|Change From Baseline in Ferritin Concentration at Treatment Day 196|Ferritin was measured before treatment and after 196 days under treatment. A positive value indicates an increase in ferritin from baseline at treatment day 196.|Baseline (visit 5, day 1) and treatment day 196|ITT, all participants with assessments at baseline and treatment day 196 for this outcome measure||ng/mL||Standard Deviation|Mean
722199|NCT00307801|Secondary|Change From Baseline in Ferritin Concentration at Treatment Day 84|Ferritin was measured before treatment and after 84 days under treatment. A positive value indicates an increase in ferritin from baseline at treatment day 84.|Baseline (visit 5, day 1) and treatment day 84|ITT, all participants with assessments at baseline and treatment day 84 for this outcome measure||ng/mL||Standard Deviation|Mean
722200|NCT00307801|Secondary|Change From Baseline in Hematocrit at Treatment Day 196.|Hematocrit was measured before treatment and after 196 days under treatment. A positive value indicates an increase in hematocrit from baseline at treatment day 196.|Baseline (visit 5) and treatment day 196|ITT, all participants with assessments at baseline and day 196 for this outcome measure||ng/mL||Standard Deviation|Mean
722201|NCT00307801|Secondary|Change From Baseline in Hemoglobin Concentration at Treatment Day 196|Hemoglobin was measured before treatment and after 196 days under treatment. A positive value indicates an increase in hemoglobin from baseline at treatment day 196.|Baseline (visit 5) and treatment day 196|ITT, all participants with assessments at baseline and day 196 for this outcome measure||g/dL||Standard Deviation|Mean
722202|NCT00307801|Secondary|Change From Baseline in Hemoglobin Concentration at Treatment Day 84|Hemoglobin was measured before treatment and after 84 days under treatment. A positive value indicates an increase in hemoglobin from baseline at treatment day 84.|Baseline (visit 5) and treatment day 84|ITT, all participants with assessments at baseline and day 84 for this outcome measure||g/dL||Standard Deviation|Mean
722203|NCT00307801|Secondary|Change From Baseline in Number of Sanitary Protection Used at 90 Days of Treatment|The number of total sanitary protection items used during the 90 days before treatment (baseline) and those used during the 90 days while under treatment was determined. A negative value indicates a reduction in the number of sanitary protection items used while under treatment compared to baseline.|Baseline and reference period of 90 days under treatment. For patients who completed up to day 6 of treatment cycle 7, the efficacy phase started on the first day of treatment cycle 4, and continued through day 6 of treatment cycle 7|ITT, all participants with assessments for baseline and efficacy phase for this outcome measure||Sanitary protection products||Standard Deviation|Mean
722204|NCT00307801|Secondary|Change From Baseline in Number of Bleeding Days to the Reference Period of 90 Days Under Treatment|A bleeding day is a day on which sanitary protection is required. The number of bleeding days was determined for the 90 days before treatment (baseline) and for 90 days while under treatment. A negative value indicates a reduction in the number of bleeding days while under treatment compared to baseline.|Baseline and reference period of 90 days under treatment. For patients who completed up to day 6 of treatment cycle 7, the efficacy phase started on the first day of treatment cycle 4, and continued through day 6 of treatment cycle 7|ITT, all participants with assessments at baseline and efficacy phase for this outcome measure||Bleeding days||Standard Deviation|Mean
722205|NCT00307801|Secondary|Change From Baseline in Number of Bleeding Episodes to the Reference Period of 90 Days Under Treatment|A bleeding episode is characterized by the following: • Bleeding for at least 2 days • Bleeding days can be separated by no more than 1 bleeding-free day • An episode stops with 2 consecutive bleeding-free days. The number of episodes was determined for the 90 days before treatment and for the 90 days under treatment. negative value indicates a reduction from baseline in the number of episodes while under treatment.|Baseline and reference period of 90 days under treatment. For patients who completed up to day 6 of treatment cycle 7, the efficacy phase started on the first day of treatment cycle 4, and continued through day 6 of treatment cycle 7|ITT, all participants with assessments at baseline and efficacy phase for this outcome measure||Bleeding episodes||Standard Deviation|Mean
722206|NCT00307801|Secondary|Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 7.|Blood loss volume as assessed by the alkaline hematin method for participants with excessive bleeding (2 or more bleeding episodes each with blood loss volume of 80 ml or more during the run-in phase) after participants were on treatment for 7 cycles. This spectrophotometrical method measures hemoglobin (Hb) in fixed amount of alkaline solution, taken from pool of solution in which materials (used sanitary protection) to be tested have been macerated for Hb extraction.|Cycle 7 = 28 days (one cycle)|ITT consisted of all randomized subjects enrolled with excessive bleeding: 2 or more bleeding episodes each with blood loss volume of 80 mL or more, as assessed by the alkaline hematin method.||ml||Standard Deviation|Mean
722207|NCT00307801|Secondary|Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 3.|Blood loss volume as assessed by the alkaline hematin method for participants with excessive bleeding (2 or more bleeding episodes each with blood loss volume of 80 ml or more during the run-in phase) after participants were on treatment for 3 cycles. This spectrophotometrical method measures hemoglobin (Hb) in fixed amount of alkaline solution, taken from pool of solution in which materials (used sanitary protection) to be tested have been macerated for Hb extraction.|Cycle 3 = 28 days (one cycle)|ITT consisted of all randomized subjects enrolled with excessive bleeding: 2 or more bleeding episodes each with blood loss volume of 80 mL or more, as assessed by the alkaline hematin method.||ml||Standard Deviation|Mean
722208|NCT00307801|Secondary|Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 1.|Blood loss volume as assessed by the alkaline hematin method for participants with excessive bleeding (2 or more bleeding episodes each with blood loss volume of 80 ml or more during the run-in phase) after participants were on treatment for one cycle. This spectrophotometrical method measures hemoglobin (Hb) in fixed amount of alkaline solution, taken from pool of solution in which materials (used sanitary protection) to be tested have been macerated for Hb extraction.|Cycle 1 = 28 days (one cycle)|ITT consisted of all randomized subjects enrolled with excessive bleeding: 2 or more bleeding episodes each with blood loss volume of 80 mL or more, as assessed by the alkaline hematin method.||ml||Standard Deviation|Mean
722209|NCT00307801|Secondary|Change From Baseline in Blood Loss Volume for Participants With Excessive Bleeding to the Reference Period of 90 Days Under Treatment.|Blood loss volume as assessed by the alkaline hematin method for participants with excessive bleeding (2 or more bleeding episodes each with blood loss volume of 80 ml or more during the run-in phase) for the 90 days before treatment (ie, run-in phase) and for the 90 days under treatment. A negative value indicates a reduction in blood loss while under treatment compared to before treatment.|Baseline and reference period of 90 days under treatment. For patients who completed up to day 6 of treatment cycle 7, the efficacy phase started on the first day of treatment cycle 4, and continued through day 6 of treatment cycle 7|ITT consisted of all randomized subjects enrolled with excessive bleeding. This spectrophotometrical method measures hemoglobin (Hb) in fixed amount of alkaline solution, taken from pool of solution in which materials (used sanitary protection) to be tested have been macerated for Hb extraction.||ml||Standard Deviation|Mean
722210|NCT00307801|Secondary|Menstrual Blood Loss Volume for All Participants at Cycle 7|Menstrual blood loss volume as assessed by the alkaline hematin method after patients were on treatment for 7 cycles. This spectrophotometrical method measures hemoglobin (Hb) in fixed amount of alkaline solution, taken from pool of solution in which materials (used sanitary protection) to be tested have been macerated for Hb extraction.|Cycle 7 = 28 days (one cycle)|ITT, all participants with assessments for this outcome measure||ml||Standard Deviation|Mean
722211|NCT00307801|Secondary|Menstrual Blood Loss Volume for All Participants at Cycle 3|Menstrual blood loss volume as assessed by the alkaline hematin method after patients were on treatment for 3 cycles. This spectrophotometrical method measures hemoglobin (Hb) in fixed amount of alkaline solution, taken from pool of solution in which materials (used sanitary protection) to be tested have been macerated for Hb extraction.|Cycle 3 = 28 days (one cycle)|ITT, all participants with assessments for this outcome measure||ml||Standard Deviation|Mean
722212|NCT00307801|Secondary|Menstrual Blood Loss Volume for All Participants at Cycle 1|Menstrual blood loss volume as assessed by the alkaline hematin method after patients were on treatment for one cycle. This spectrophotometrical method measures hemoglobin (Hb) in fixed amount of alkaline solution, taken from pool of solution in which materials (used sanitary protection) to be tested have been macerated for Hb extraction.|Cycle 1 = 28 days (one cycle)|ITT, all participants with assessments for this outcome measure||ml||Standard Deviation|Mean
722213|NCT00307801|Secondary|Change From Baseline in Blood Loss Volume for All Participants to the Reference Period of 90 Days Under Treatment|Menstrual blood loss volume as assessed by the alkaline hematin method for the 90 days before treatment (baseline) and for 90 days under treatment. This spectrophotometrical method measures hemoglobin (Hb) in fixed amount of alkaline solution, taken from pool of solution in which materials (used sanitary protection) to be tested have been macerated for Hb extraction. A negative value indicates a reduction in blood loss after treatment.|Baseline and reference period of 90 days under treatment. For patients who completed up to day 6 of treatment cycle 7, the efficacy phase started on the first day of treatment cycle 4, and continued through day 6 of treatment cycle 7|ITT, all participants with assessments at baseline and efficacy phase for this outcome measure||ml||Standard Deviation|Mean
722214|NCT00307801|Secondary|Proportion of Participants With Improvement in the Patient’s Overall Assessment Scale at Treatment Day 196|According to the patient´s global assessment scale “improved” was defined as being classified as ‘very much improved’, ‘much improved’, or ‘improved’ and “not improved” was defined as being classified as ‘no change’, ‘worse’, ‘much worse’, ‘very much worse’, or ‘not assessed’. Patients assessed the overall improvement at day 196 compared with admission to the study condition.|From baseline (visit 5, day 1) up to treatment day 196|ITT, all participants with assessment at day 196 for this outcome measure||Proportion of participants|||Number
722215|NCT00307801|Secondary|Proportion of Participants With Improvement in the Patient’s Overall Assessment Scale at Treatment Day 84|According to the patient’s global assessment scale “improved” was defined as being classified as ‘very much improved’, ‘much improved’, or ‘improved’ and “not improved” was defined as being classified as ‘no change’, ‘worse’, ‘much worse’, ‘very much worse’, or ‘not assessed’. Patients assessed the overall improvement at day 84 compared with admission to the study condition.|From baseline (visit 5, day 1) up to treatment day 84|ITT, all participants with assessment at day 84 for this outcome measure||Proportion of participants|||Number
722216|NCT00307801|Secondary|Proportion of Participants With Improvement in the Investigator’s Global Assessment Scale at Treatment Day 196|According to the investigator’s global assessment scale “improved” was defined as being classified as ‘very much improved’, ‘much improved’, or ‘improved’ and “not improved” was defined as being classified as ‘no change’, ‘worse’, ‘much worse’, ‘very much worse’, or ‘not assessed’. Central laboratory data, physical examination, e-diary data, and patient interview were used as sources for the assessment at day 196 compared with admission to study data.|From baseline (visit 5, day 1) up to treatment day 196|ITT, all participants with assessment at day 196 for this outcome measure||Proportion of participants|||Number
722217|NCT00307801|Secondary|Proportion of Participants With Improvement in the Investigator’s Global Assessment Scale at Treatment Day 84|According to the investigator’s global assessment scale “improved” was defined as being classified as ‘very much improved’, ‘much improved’, or ‘improved’ and “not improved” was defined as being classified as ‘no change’, ‘worse’, ‘much worse’, ‘very much worse’, or ‘not assessed’. Central laboratory data, physical examination, e-diary data, and patient interview were used as sources for the assessment at day 84 compared with admission to study data.|From baseline (visit 5, day 1) up to treatment day 84|ITT, all participants with assessment at day 84 for this outcome measure||Proportion of participants|||Number
722218|NCT00307801|Secondary|Proportion of Participants Cured From Frequent Bleeding|Frequent bleeding: greater than 5 bleeding episodes, with a minimum of 20 bleeding days overall. Cure from frequent bleeding: no more than 4 bleeding episodes and the total number of bleeding days did not exceed 24 days and no increase from baseline in an individual patient’s total number of bleeding days occurred|Efficacy phase was defined as a 90-day period under treatment. For patients who completed up to day 6 of treatment cycle 7, the efficacy phase started on the first day of treatment cycle 4, and continued through day 6 of treatment cycle 7|The ITT population consisted of all randomized subjects who enrolled with frequent bleeding: greater than 5 bleeding episodes, with a minimum of 20 bleeding days overall|||||
722219|NCT00307801|Secondary|Proportion of Participants Cured From Excessive Bleeding|Excessive bleeding:>=2 bleeding episodes each with blood loss volume (MBL) of >=80 mL in 90-day period, assessed by alkaline hematin method. This spectrophotometrical method measures hemoglobin (Hb) in fixed amount of alkaline solution, taken from pool of solution in which materials (used sanitary protection) to be tested have been macerated for Hb extraction. Cure from excessive bleeding: MBL in each episode <80 mL + blood loss volume associated with each bleeding episode is decrease of ≥50% from average of qualifying bleeding episodes (with blood loss volume ≥80 mL per episode during run-in)|Efficacy phase was defined as a 90-day period under treatment. For patients who completed up to day 6 of treatment cycle 7, the efficacy phase started on the first day of treatment cycle 4, and continued through day 6 of treatment cycle 7|The ITT population consisted of all randomized subjects who enrolled with excessive bleeding: 2 or more bleeding episodes each with blood loss volume of 80 mL or more in a 90-day run-in period, as assessed by the alkaline hematin method||Proportion of participants|||Number
722220|NCT00307801|Secondary|Proportion of Participants Cured From Prolonged Bleeding|Prolonged bleeding: 2 or more bleeding episodes, each lasting 8 or more days. Cure from prolonged bleeding: no bleeding episodes lasting more than 7 days and the decrease between maximum duration during run-in and maximum duration during the efficacy phase was at least 2 days.|Efficacy phase was defined as a 90-day period under treatment. For patients who completed up to day 6 of treatment cycle 7, the efficacy phase started on the first day of treatment cycle 4, and continued through day 6 of treatment cycle 7|The ITT population consisted of all randomized subjects with prolonged bleeding: 2 or more bleeding episodes, each lasting 8 or more days||Proportion of participants|||Number
722221|NCT00307801|Primary|Proportion of Participants With no Dysfunctional Uterine Bleeding (DUB) Symptoms|At least 6, up to 8 criteria to be met in complete response during 90-day period: no bleeding episodes(BE) >7 days, no >4 BE, no BE with blood loss (menstrual blood loss, MBL) ≥80 mL, no >1 BE increase from baseline, no increase from baseline in individual patient’s total number of bleeding days and total number of bleeding days not >24 days. Additionally, for subjects included with prolonged bleeding: decrease between maximum duration during run-in and efficacy ≥2 days excessive bleeding: MBL associated with each episode decreased by ≥50% from average of qualifying episodes during run-in.|Efficacy phase was defined as a 90-day period under treatment. For patients who completed up to day 6 of treatment cycle 7, the efficacy phase started on the first day of treatment cycle 4, and continued through day 6 of treatment cycle 7|Intent-To-Treat (ITT): all randomized subjects with ≥1 of the DUB symptoms in 90-day run-in phase: Prolonged bleeding: ≥2 bleeding episodes, each lasting ≥8 days Frequent bleeding: >5 bleeding episodes, with minimum of 20 bleeding days overall. Excessive bleeding: ≥2 bleeding episodes each with blood loss volume (=MBL) of ≥80 mL||Proportion of participants|||Number
722222|NCT00307931|Secondary|Inflammatory Bowel Disease Questionnaire (IBDQ) Social Function Domain Score at Baseline, and Weeks 6 and 14|The IBDQ Social Function Domain Score is the sum of 8 responses, each ranging from 0 to 7, thus the score ranges from 0 to 56; a higher score indicating a better quality of life.|Baseline, and Weeks 6 and 14|Due to the low number of subjects recruited only an abbreviated report was produced with limited analyses. This outcome measure was not included in the limited analyses.||Units on a scale||Standard Deviation|Mean
722223|NCT00307931|Secondary|Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Function Domain Score at Baseline, and Weeks 6 and 14|The IBDQ Emotional Function Domain Score is the sum of 8 responses, each ranging from 0 to 7, thus the score ranges from 0 to 56; a higher score indicating a better quality of life.|Baseline, and Weeks 6 and 14|Due to the low number of subjects recruited only an abbreviated report was produced with limited analyses. This outcome measure was not included in the limited analyses.||Units on a scale||Standard Deviation|Mean
722224|NCT00307931|Secondary|Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Symptoms Domain Score at Baseline, and Weeks 6 and 14|The IBDQ Systemic Symptoms Domain Score is the sum of 8 responses, each ranging from 0 to 7, thus the score ranges from 0 to 56; a higher score indicating a better quality of life.|Baseline, and Weeks 6 and 14|Due to the low number of subjects recruited only an abbreviated report was produced with limited analyses. This outcome measure was not included in the limited analyses.||Units on a scale||Standard Deviation|Mean
722225|NCT00307931|Secondary|Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Symptoms Domain Score at Baseline, and Weeks 6 and 14|The IBDQ Bowel Symptoms Domain Score is the sum of 8 responses, each ranging from 0 to 7, thus the score ranges from 0 to 56; a higher score indicating a better quality of life.|Baseline, and Weeks 6 and 14|Due to the low number of subjects recruited only an abbreviated report was produced with limited analyses. This outcome measure was not included in the limited analyses.||Units on a scale||Standard Deviation|Mean
722226|NCT00307931|Secondary|Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Baseline, and Weeks 6 and 14|The IBDQ Total Score is the sum of 32 responses, each ranging from 0 to 7, thus the Total Score ranges from 0 to 224; a higher score indicating a better quality of life.|Baseline, and Weeks 6 and 14|Due to the low number of subjects recruited only an abbreviated report was produced with limited analyses. This outcome measure was not included in the limited analyses.||Units on a scale||Standard Deviation|Mean
722228|NCT00307931|Secondary|Change From Baseline in Crohn's Disease Activity Index (CDAI) Score at Each of Weeks 1, 2, 4, 6, 8, 12 and 14|The CDAI score is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Weeks 1, 2, 4, 6, 8, 12 and 14|Due to the low number of subjects recruited only an abbreviated report was produced with limited analyses. This outcome measure was not included in the limited analyses.||score on a scale|||Number
722229|NCT00307931|Secondary|Crohn's Disease Activity Index (CDAI) Score at Each of Weeks 1, 2, 4, 6, 8, 12 and 14|The CDAI score is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Weeks 1, 2, 4, 6, 8, 12 and 14|Due to the low number of subjects recruited only an abbreviated report was produced with limited analyses. This outcome measure was not included in the limited analyses.||score on a scale|||Number
722230|NCT00307931|Secondary|Number of Patients With a Crohn's Disease Activity Index (CDAI) Score ≤150 (Remission) at Weeks 1, 6 and 14 or Withdrawal|The CDAI score is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Weeks 1, 6 and 14 or Withdrawal|This outcome is based on the Intent-to-Treat population, defined as all subjects who were enrolled and received at least 1 dose of study medication (N=16).||participants|||Number
722231|NCT00307931|Secondary|Number of Patients With at Least a 70-point Decrease From Baseline in Crohn's Disease Activity Index (CDAI) Score at Weeks 1, 6 and 14|The CDAI score is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Weeks 1, 6 and 14|Due to the low number of subjects recruited only an abbreviated report was produced with limited analyses. This outcome measure was not included in the limited analyses.||participants|||Number
722232|NCT00307931|Secondary|Number of Patients With at Least a 100-point Decrease From Baseline in Crohn's Disease Activity Index (CDAI) Score at Weeks 1, and 14 or Withdrawal|The CDAI score is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Weeks 1, and 14 or Withdrawal|This outcome is based on the Intent-to-Treat population, defined as all subjects who were enrolled and received at least 1 dose of study medication (N=16).||participants|||Number
722233|NCT00307931|Primary|Number of Patients With at Least a 100-point Decrease From Baseline in Crohn’s Disease Activity Index (CDAI) Score at Week 6|The CDAI score is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline, Week 6|This outcome is based on the Intent-to-Treat population, defined as all subjects who were enrolled and received at least 1 dose of study medication (N=16).||participants|||Number
722234|NCT00314574|Secondary|Number of Participants Assessed for Frequency and Severity of Treatment-emergent Adverse Events|This outcome is represented in the adverse event section of the database.|Week 48|Safety Population: The safety-evaluable population comprised 848 patients (428 Xolair group and 420 placebo group). Patients in the safety-evaluable population were analyzed according to the actual treatment received. One subject was assigned to receive placebo but inadvertently received at least one dose of xolair during the study.||participants|||Number
722235|NCT00314574|Secondary|Change From Baseline in Overall Asthma-related Quality of Life|Change from baseline to week 48 in overall asthma-specific health-related quality of life, as measured by the standardized version of the Asthma Quality of Life Questionnaire (AQLQ[S]) score. The AQLQ(S) consists of 4 domains (activity limitations, symptoms, emotional function, and environmental stimuli), with a total of 32 items; the overall score is the mean of these 32 items on a scale of 1 to 7 (1 = severe impairment, 7 = no impairment). Overall outcome achieved by mean visit minus baseline.|Baseline and Week 48|Modified Intent-to-Treat population included all randomized patients who received at least 1 dose of study drug (Xolair or placebo). Five patients were missing baseline values and were excluded from the analyses. The Last Observation Carried Forward was used to impute missing values at week 48 for patients who discontinued the study early.||score on a scale||Standard Deviation|Mean
722236|NCT00314574|Secondary|Change From Baseline in the Number of Puffs Per Day of Beta Agonist Rescue Medication|Change from baseline to week 48 in mean puffs per day of albuterol. Puffs per day was achieved by week 48 minus baseline.|Baseline and Week 48|Modified Intent-to-Treat population included all randomized patients who received at least 1 dose of study drug (Xolair or placebo). Five patients were missing baseline values and were excluded from the analyses. The Last Observation Carried Forward was used to impute missing values at week 48 for patients who discontinued the study early.||puffs per day||Standard Deviation|Mean
722237|NCT00314574|Secondary|Change From Baseline in Total Asthma Symptom Scores|Change from baseline to week 48 in Total Asthma Symptom Score (TASS), which included a nocturnal asthma score (0 to 4 scale), morning asthma symptoms (yes or no), and a daytime asthma symptom score (0 to 4 scale, total score range 0 to 9, higher TASS scores represent worse symptoms; breathlessness, tightness in chest, wheezing and cough. Score achieved by week 48 minus baseline.|Baseline and Week 48|Modified Intent-to-Treat population included all randomized patients who received at least 1 dose of study drug. Ten patients were missing baseline values and were excluded from the analyses. The Last Observation Carried Forward was used to impute missing values at week 48 for patients who discontinued the study early.||score on a scale||Standard Deviation|Mean
722238|NCT00314574|Primary|Rate of Asthma Exacerbations Over the 48 Week Treatment Period|A protocol-defined asthma exacerbation was defined as worsening of asthma symptoms requiring treatment with systemic corticosteroids for 3 or more days; for patients receiving long-term oral corticosteroids, an exacerbation was a 20 mg or more increase in average daily dose of oral prednisone (or a similar dose of another systemic corticosteroid). The rate of protocol-defined asthma exacerbations, normalized by subject-time at risk and computed over the 48 week treatment period in each treatment group.|48 weeks|Modified Intent-to-Treat population included all randomized patients who received at least 1 dose of study drug (Xolair or placebo).||exacerbation/patient-week|||Number
722239|NCT00314808|Secondary|Mean Change From Baseline in Quality of Life -- MMSE|The mean change between baseline and post-treatment in quality of life as measured by the Mini Mental Status Exam (MMSE). Change is computed as the MMSE level at month 2 minus MMSE level at baseline. MMSE is an 11-item questionnaire used to measure global cognitive status with scores ranging from 0 to 30; higher scores are an indication of greater cognitive function.|baseline and 2 months|17 patients provided both a pre- and post-treatment assessment of MMSE.||units on a scale||Standard Deviation|Mean
722240|NCT00314808|Secondary|Mean Change From Baseline in Quality of Life -- FLIE|The mean change from baseline in quality of life as measured by the Functional Living Index Emesis (FLIE) scale during the first 24 and 72 hours of cycle 1. Change at 24 hours was computed as the 24 hour FLIE assessment minus the baseline assessment; whereas, change at 72 hours was computed as the 72 hour FLIE assessment minus the baseline assessment. The FLIE consists of 18 items for nausea and appetite on a 7-point scale. The effect of nausea and vomiting is measured by physical activity, social, and emotional function. Higher scores indicate less difficulty and interference with nausea and vomiting. Scores for the two subscales (nausea and vomiting) range between 0 and 54.|baseline, 24 hours, and 72 hours|For cycle 1, 28 patients with a baseline and follow-up assessment are included in the analysis of change at 24 and 72 hours.||units on a scale||Standard Deviation|Mean
722241|NCT00314808|Secondary|Mean Change From Baseline in Quality of Life -- FACT-Br|The mean change between baseline and post-treatment in quality of life as measured by the Functional Assessment of Cancer Therapy-Brain (FACT-Br), where change is computed as quality of life at 2 months minus quality of life at baseline. The FACT-Br instrument consists of 54 items to assess physical(PWB), social and family (SWB), emotional (EWB), functional well-being (FWB), and additional brain cancer specific concerns (AC). Using a 5-point Likert type scale, responses to individual items range from 0 (not at all) to 4 (Very Much) with higher scores indicating better quality of life. PWB, SWB, and FWB are the sum of 7 items and have a possible range between 0 and 28. EWB ranges between 0 and 24, and is the sum of 6 items. AC is the sum of 19 items, and ranges between 0 and 76.|baseline and 2 months|19 patients provided both baseline and follow-up assessments; however, only 11 patients provided adequate information to compute the score for the additional brain cancer specific concerns subscale.||units on a scale||Standard Deviation|Mean
722242|NCT00314808|Primary|Unacceptable Toxicity Rate|Percentage of participants who experience one or more adverse events attributable to Dronabinol of the following types or grades: ≥Grade 3 non-hematologic, ≥Grade 2 hepatic/metabolic or ≥Grade 4 neuro toxicities|2 months|All treated patients||percentage of participants||95% Confidence Interval|Number
722243|NCT00314808|Primary|Tolerability Rate|Percentage of participants where the 2 cycles of Dronabinol is tolerable. The treatment regimen is considered intolerable if (1) at least two adverse events of the following types that are attributed to Dronabinol during the 2 cycles of treatment occur: ≥Grade 3 non-hematologic, ≥Grade 2 hepatic/metabolic or ≥Grade 4 neuro toxicities, or (2) Dronabinol treatment is terminated early due to adverse events|Two months|25 of the 33 patients treated with Dronabinol completed 2 cycles of protocol treatment or terminated protocol treatment due to adverse events. The remaining 8 patients are excluded from this tabulation as they terminated Dronabinol treatment before completion of 2 cycles of treatment for reasons unrelated to adverse events.||percentage of participants||95% Confidence Interval|Number
722244|NCT00314951|Other Pre-specified|Global Cure|Percentage of participants who were cured (3 or fewer unformed stools for 2 days through the end of therapy, and no C. difficile therapy after study drug completion) and didn't have recurrence (re-establishment of diarrhea that was greater than on the last day of study drug, positive C. difficile toxin and retreatment with C. difficile therapy) up to Day 40.|End of Study (Day 40)|The analysis population is mITT, subjects that achieved a cure response at end of treatment and not having a recurrence at any time up to the Post-study visit.||Percentage of Participants|||Number
722245|NCT00314951|Secondary|Recurrence|Percentage of participants with the re-establishment of diarrhea to an extent(based on frequency of passed unformed stools) that was greater than that noted on the last day of study medication, and the demonstration of either toxin A or B or both of C. difficile, and retreatment with CDI anti-infective therapy was needed.|Study days 11-40|The mITT population for subjects who met the primary endpoint of cure subjects, were analyzed for the recurrence rates of diarrhea up to the Poststudy Visit.||Percentage of Participants|||Number
722246|NCT00314951|Primary|Cure Rate at End of Therapy|Percentage of participants with 3 or fewer unformed stools for 2 consecutive days and maintained through the end of therapy, and the subject no longer needed specific anti-Clostridium antibacterial treatment after completion of the course of study medication.|Study day 10 (+/- 2 days)|Analysis data is modified intent to treat (mITT) population. The mITT population consists of subjects that had CDAD confirmed by >3 unformed bowel movements in the 24 hours prior to randomization and a positive toxin assay and received at least one dose of study medication.||Percentage of Participants||95% Confidence Interval|Number
722247|NCT00315055|Secondary|Number of Participants With at Least a Solicited Injection Site or Systemic Reaction After Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®|Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability|Day 0 to Day 7 post any dose|Solicited reactions were assessed in all participants who received at least 1 injection of study vaccine (Safety Analysis Set) according to the vaccine actually received.||Participants|||Number
722248|NCT00315055|Secondary|Geometric Mean Titers of Antibodies After the 3 Dose Primary Series With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®|Antibodies to hepatitis B surface antigen (HBs) were measured by means of automated enhanced chemoluminescence assay. Antibodies to PRP, tetanus, pertussis toxoid (PT), and filamentous hemagglutinin (FHA) were measured by enzyme linked immunosorbent assay (ELISA), and antibodies to diphtheria were measured by a neutralization test using crystal violet.|Day 90 (30 Days post-dose 3)|Geometric Mean Titers were assessed in all participants who did not have any protocol violation that might have interfered with the primary criteria evaluation (Per-Protocol Population). Totals are number of participants with available data for the endpoint.||Titers||95% Confidence Interval|Geometric Mean
722270|NCT00315120|Secondary|Medical Outcomes Study SF-36 Health Survey (OMT and Sham OMT - Week 4)|The general health scale ranges from 0 to 100, with higher scores representing better general health.|4 weeks|||SF-36 General Health Score||Inter-Quartile Range|Median
722249|NCT00315055|Secondary|Percentage of Participants With Anti-Pertussis Seroconversion After the 3 Dose Primary Series Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®|Antibodies to pertussis toxoid (PT) and filamentous hemagglutinin (FHA) were measured by means of enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as a ≥ 4-fold increase in titer between baseline (Day 0 pre-vaccination and Day 30 post-dose 3 (Day 90).|Day 0 (pre-vaccination) and Day 30 post-dose 3|Anti-pertussis antibodies were assessed in all participants who did not have any protocol violation that might have interfered with the primary criteria evaluation (Per-Protocol Population). Totals are number of participants with available data for the endpoint.||Percentage of Participants|||Number
722250|NCT00315055|Secondary|Percentage of Participants With Seroprotection Against Poliovirus Antigens After the 3 Dose Primary Series Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®|Antibodies to poliovirus types 1, 2, and 3 were measured by microneutralization on Vero cell culture. Seroprotection was defined as titers ≥8 1/dil.|Day 90 post first dose|Anti poliovirus antibodies were assessed in all participants who did not have any protocol violation that might have interfered with the primary criteria evaluation (Per-Protocol Population). Totals are number of participants with available data for the endpoint.||Percentage of Participants|||Number
722251|NCT00315055|Secondary|Percentage of Participants With Seroprotection Against Hepatitis B Surface Antigen, Polyribosyl Ribitol Phosphate, Diptheria, and Tetanus After the 3 Dose Primary Series With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ + ENGERIX B®|Antibodies to hepatitis B surface antigen (HBs) were measured by means of automated enhanced chemoluminescence assay. Antibodies to Polyribosyl ribitol phosphate and tetanus were measured by enzyme linked immunosorbent assay (ELISA), and antibodies to diphtheria were measured by a neutralization test using crystal violet. Seroprotection was defined as: titers ≥ 100 mIU/mL for HBs; ≥ 0.01 and ≥ 0.1 IU/mL for anti-Tetanus and anti-diphtheria, and ≥ 0.15 µg/mL and ≥ 1.0 µg/mL for anti-PRP.|Day 90 post first dose|Seroprotection was assessed in all participants who did not have any protocol violation that might have interfered with the primary criteria evaluation (Per-Protocol Population). Totals are number of participants with available data for the endpoint.||Percentage of Participants|||Number
722252|NCT00315055|Primary|Percentage of Participants With Anti HBs Seroprotection After the 3 Dose Primary Vaccination Series With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ + ENGERIX B® Vaccines|Antibodies to hepatitis B surface antigen (HBs) were measured by means of automated enhanced chemoluminescence assay. Seroprotection was defined as a titer ≥ 10 mIU/mL.|Day 90 post first dose|Seroprotection against HBs was assessed in all participants who did not have any protocol violation that might have interfered with the primary criteria evaluation (Per-Protocol Population). Totals are number of participants with available data for the endpoint.||Percentage of Participants|||Number
722253|NCT00315120|Secondary|Satisfaction With Back Care (UST and Sham UST - Week 12)|Subjects who reported being very satisfied with back care|12 weeks|||participants||95% Confidence Interval|Number
722254|NCT00315120|Secondary|Satisfaction With Back Care (UST and Sham UST - Week 8)|Subjects who reported being very satisfied with back care|8 weeks|||participants||95% Confidence Interval|Number
722255|NCT00315120|Secondary|Satisfaction With Back Care (UST and Sham UST - Week 4)|Subjects who reported being very satisfied with back care|4 weeks|||participants||95% Confidence Interval|Number
722256|NCT00315120|Secondary|Satisfaction With Back Care (OMT and Sham OMT - Week 12)|Subjects who reported being very satisfied with back care|12 weeks|||participants||95% Confidence Interval|Number
722257|NCT00315120|Secondary|Satisfaction With Back Care (OMT and Sham OMT - Week 8)|Subjects who reported being very satisfied with back care|8 weeks|||participants||95% Confidence Interval|Number
722258|NCT00315120|Secondary|Satisfaction With Back Care (OMT and Sham OMT - Week 4)|Subjects who reported being very satisfied with back care|4 weeks|||participants||95% Confidence Interval|Number
722259|NCT00315120|Secondary|Work Disability (UST and Sham UST - Week 12)|Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain.|12 weeks|Lost 1 or more days of work in past 4 weeks because of low back pain.||Participants who reported lost work days||95% Confidence Interval|Number
722260|NCT00315120|Secondary|Work Disability (UST and Sham UST - Week 8)|Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain.|8 weeks|Lost 1 or more days of work in past 4 weeks because of low back pain.||Participants who reported lost work days||95% Confidence Interval|Number
722261|NCT00315120|Secondary|Work Disability (UST and Sham UST - Week 4)|Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain.|4 weeks|Lost 1 or more days of work in past 4 weeks because of low back pain.||Participants who reported lost work days||95% Confidence Interval|Number
722262|NCT00315120|Secondary|Work Disability (OMT and Sham OMT - Week 12)|Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain.|12 weeks|Lost 1 or more days of work in past 4 weeks because of low back pain.||Participants who reported lost work days||95% Confidence Interval|Number
722263|NCT00315120|Secondary|Work Disability (OMT and Sham OMT - Week 8)|Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain.|8 weeks|Lost 1 or more days of work in past 4 weeks because of low back pain.||Participants who reported lost work days||95% Confidence Interval|Number
722264|NCT00315120|Secondary|Work Disability (OMT and Sham OMT - Week 4)|Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain.|4 weeks|Lost 1 or more days of work in past 4 weeks because of low back pain.||Participants who reported lost work days||95% Confidence Interval|Number
722265|NCT00315120|Secondary|Medical Outcomes Study SF-36 Health Survey (UST and Sham UST - Week 12)|The general health scale ranges from 0 to 100, with higher scores representing better general health.|12 Weeks|||SF-36 General Health Score||Inter-Quartile Range|Median
722266|NCT00315120|Secondary|Medical Outcomes Study SF-36 Health Survey (UST and Sham UST - Week 8)|The general health scale ranges from 0 to 100, with higher scores representing better general health.|8 Weeks|||SF-36 General Health Score||Inter-Quartile Range|Median
722267|NCT00315120|Secondary|Medical Outcomes Study SF-36 Health Survey (UST and Sham UST - Week 4)|The general health scale ranges from 0 to 100, with higher scores representing better general health.|4 Weeks|||SF-36 General Health Score||Inter-Quartile Range|Median
722271|NCT00315120|Secondary|Roland Morris Disability Questionnaire (UST and Sham UST - Week 12)|Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning.|12 weeks|Week 12 Data||RMDQ Scale||Inter-Quartile Range|Median
722272|NCT00315120|Secondary|Roland Morris Disability Questionnaire (UST and Sham UST - Week 8)|Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning.|8 weeks|Week 8 Data||RMDQ Scale||Inter-Quartile Range|Median
722273|NCT00315120|Primary|Change in Visual Analogue Scale Score for Pain Over 12 Weeks (Active UST vs Sham UST)|"Comparison of the number (proportion) of participants in each study group who achieve a substantial improvement in low back pain over 12 weeks as determined by at least a 40-mm reduction (-40 mm) on the visual analogue scale score for pain compared with the baseline score. Changes in the visual analogue scale scores for pain over 12 weeks may potentially range from a 100-mm reduction (-100 mm) to a 100-mm increase (+100). Any reduction (negative score) represents an improvement in low back pain (i.e., a better outcome), while any increase (positive score) represents a worsening of low back pain (i.e., a worse outcome). However, only those better outcomes represented by change scores less than or equal to -40 mm are considered to represent substantial improvement in low back pain, which is the primary outcome measure of this study. For analyses wherein floor effects are important, the 40-mm reduction threshold for substantial improvement may be replaced by 50% reduction (-50%)."|12 weeks|||participants|||Number
722274|NCT00315120|Secondary|Roland Morris Disability Questionnaire (UST and Sham UST - Week 4)|Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning.|4 weeks|Week 4 Data||RMDQ Scale||Inter-Quartile Range|Median
722275|NCT00315120|Secondary|Roland Morris Disability Questionnaire (OMT and Sham OMT - Week 12)|Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning.|12 weeks|Week 12 Data||RMDQ Scale||Inter-Quartile Range|Median
722276|NCT00315120|Secondary|Roland Morris Disability Questionnaire (OMT and Sham OMT - Week 8)|Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning.|8 weeks|Week 8 Data||RMDQ Scale||Inter-Quartile Range|Median
722277|NCT00315120|Secondary|Roland Morris Disability Questionnaire (OMT and Sham OMT - Week 4)|Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning.|4 weeks|Week 4 Data||RMDQ Scale||Inter-Quartile Range|Median
722278|NCT00315120|Primary|Change in Visual Analogue Scale Score for Pain Over 12 Weeks (OMT vs Sham OMT)|"Comparison of the number (proportion) of participants in each study group who achieve a substantial improvement in low back pain over 12 weeks as determined by at least a 40-mm reduction (-40 mm) on the visual analogue scale score for pain compared with the baseline score. Changes in the visual analogue scale scores for pain over 12 weeks may potentially range from a 100-mm reduction (-100 mm) to a 100-mm increase (+100). Any reduction (negative score) represents an improvement in low back pain (i.e., a better outcome), while any increase (positive score) represents a worsening of low back pain (i.e., a worse outcome). However, only those better outcomes represented by change scores less than or equal to -40 mm are considered to represent substantial improvement in low back pain, which is the primary outcome measure of this study. For analyses wherein floor effects are important, the 40-mm reduction threshold for substantial improvement may be replaced by 50% reduction (-50%)."|12 weeks|||participants|||Number
722279|NCT00315146|Secondary|Lean Body Mass||Baseline visit (pre intervention) and 4month follow up (post intervention)|||kg||95% Confidence Interval|Least Squares Mean
722280|NCT00315146|Primary|Appendicular Non-bone Lean Mass|Change in Appendicular Non-bone Lean Mass|Baseline visit (pre intervention) and 4month follow up (post intervention)|||kg||95% Confidence Interval|Least Squares Mean
722281|NCT00315302|Secondary|Visual Acuity Distribution in the Sound Eye|"Acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at baseline and at 18 wks resulting in a Snellen acuity score that can range from 20/16 to 20/800. This acuity score is converted to logMAR (log of min angle of resolution) for statistical analysis.
20/16=-0.1 logMAR; best 20/20=0.0 logMAR; 20/25=0.1; 20/32=0.2; 20/40=0.3; 20/50=0.4; 20/63=0.5; 20/80=0.6; 20/100=0.7; 20/125=0.8; 20/160=0.9; 20/200=1.0; 20/250=1.1; 20/320=1.2; 20/400=1.3; 20/500=1.4; 20/640=1.5; 20/800=1.6; worst"|18 weeks|||Participants|||Number
722282|NCT00315302|Secondary|Distribution of Change in Visual Acuity in the Sound Eye|"Acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at baseline and at 18wks resulting in a Snellen acuity score that can range from 20/16 to 20/800. The score is converted to logMAR (log of min angle of resolution) for statistical analysis, and a difference between the scores is calculated.
A positive difference indicates acuity was better at 18wks than at baseline; a negative difference indicates acuity was worse at 18wks than at baseline."|baseline to 18 weeks|||Participants|||Number
722283|NCT00315302|Secondary|Mean Change in Visual Acuity in the Sound Eye|"Acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at baseline and at 18wks resulting in a Snellen acuity score that can range from 20/16 to 20/800. The score is converted to logMAR (log of min angle of resolution) for statistical analysis, and a difference between the scores is calculated.
A positive difference indicates acuity was better at 18wks than at baseline; a negative difference indicates acuity was worse at 18wks than at baseline."|baseline to 18 weeks|||logMAR units||Standard Deviation|Mean
722284|NCT00315302|Secondary|Randot Preschool Stereoacuity at 18 Weeks- Anisometropic Participants Only|The Randot Preschool Stereotest measures stereopsis from 800 to 40 seconds of arc on patients as young as 2 years of age. This Stereotest is designed as a matching game in which the patient matches pictures in a test booklet wearing special glasses. A subject can fail the pretest (not see any pictures) or can score >800 (the worst), 800, 400, 200, 100, 60, or 40 (the best) seconds of arc. If two shapes are identified correctly the patient progresses to the next lower stereoacuity level. A failed test occurs when the patient cannot identify any shapes.|18 weeks|Not reported among subjects with severe amblyopia||Participants|||Number
722298|NCT00315328|Secondary|Amblyopia Treatment Index - Adverse Effects Scale (Moderate Amblyopia Only)|Questionnaire scores on the adverse events subscale of the Amblyopia Treatment Index. Questions were evaluated on a likert type scale as strongly agree (5) to strongly disagree (1), with a higher number indicating worse response.|17 weeks|Number of subjects who completed the 17wk amblyopia treatment index questionnaire evaluating the impact of treatment on the child and family.||Units on a scale||Standard Deviation|Mean
722285|NCT00315302|Secondary|Randot Preschool Stereoacuity at 18 Weeks- Participants With All Causes of Amblyopia|The Randot Preschool Stereotest measures stereopsis from 800 to 40 seconds of arc on patients as young as 2 years of age. This Stereotest is designed as a matching game in which the patient matches pictures in a test booklet wearing special glasses. A subject can fail the pretest (not see any pictures) or can score >800 (the worst), 800, 400, 200, 100, 60, or 40 (the best) seconds of arc. If two shapes are identified correctly the patient progresses to the next lower stereoacuity level. A failed test occurs when the patient cannot identify any shapes.|18 weeks|Not reported among subjects with severe amblyopia||Participants|||Number
722286|NCT00315302|Primary|Distribution of Change in Visual Acuity in the Amblyopic Eye|"Acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at baseline and at 18wks resulting in a Snellen acuity score that can range from 20/16 to 20/800. The score is converted to logMAR (log of min angle of resolution) for statistical analysis, and a difference between the scores is calculated.
A positive difference indicates acuity was better at 18wks than at baseline; a negative difference indicates acuity was worse at 18wks than at baseline."|baseline to 18 weeks|||Participants|||Number
722287|NCT00315302|Primary|Mean Change in Visual Acuity in the Amblyopic Eye|"Acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at baseline and at 18wks resulting in a Snellen acuity score that can range from 20/16 to 20/800. The score is converted to logMAR (log of min angle of resolution) for statistical analysis, and a difference between the scores is calculated.
A positive difference indicates acuity was better at 18wks than at baseline; a negative difference indicates acuity was worse at 18wks than at baseline."|baseline to 18 weeks|||logMAR units||Standard Deviation|Mean
722288|NCT00315302|Primary|Visual Acuity Distribution in the Amblyopic Eye|"Visual acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at 18 weeks resulting in a Snellen acuity score that can range from 20/16 to 20/800. This visual acuity score is converted to logMAR (log of min angle of resolution) for statistical analysis.
20/16=-0.1 logMAR; best 20/20=0.0 logMAR; 20/25=0.1; 20/32=0.2; 20/40=0.3; 20/50=0.4; 20/63=0.5; 20/80=0.6; 20/100=0.7; 20/125=0.8; 20/160=0.9; 20/200=1.0; 20/250=1.1; 20/320=1.2; 20/400=1.3; 20/500=1.4; 20/640=1.5; 20/800=1.6; worst"|18 weeks|||Participants|||Number
722289|NCT00315302|Primary|Visual Acuity Mean Score in the Amblyopic Eye|"Visual acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at 18 weeks resulting in an Snellen equivalent acuity score that can range from 20/16 to 20/800. This visual acuity score is converted to logMAR (log of min angle of resolution) for statistical analysis.
20/16=-0.1 logMAR; best 20/20=0.0 logMAR; 20/25=0.1; 20/32=0.2; 20/40=0.3; 20/50=0.4; 20/63=0.5; 20/80=0.6; 20/100=0.7; 20/125=0.8; 20/160=0.9; 20/200=1.0; 20/250=1.1; 20/320=1.2; 20/400=1.3; 20/500=1.4; 20/640=1.5; 20/800=1.6; worst"|18 weeks|Primary analysis includes only patients who completed the 18 week exam. No imputation was done if missed exam; analysis followed the intent to treat principle.||logMAR units||Standard Deviation|Mean
722290|NCT00315328|Secondary|Mean Change in Visual Acuity in the Fellow Eye From Baseline to 17 Weeks|"Visual acuity was measured at baseline and 17 weeks in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference between the scores at baseline and 17 weeks was calculated.
A positive difference indicates acuity was better at 17 weeks than at baseline; a negative difference indicates acuity was worse at 17 weeks."|Baseline to 17 weeks|||ETDRS letter score||Standard Deviation|Mean
722291|NCT00315328|Secondary|Distribution of Change in Visual Acuity in the Fellow Eye From Baseline to 17 Weeks|"Visual acuity was measured at baseline and 17 weeks in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference between the scores at baseline and 17 weeks was calculated.
A positive difference indicates acuity was better at 17 weeks than at baseline; a negative difference indicates acuity was worse at 17 weeks."|Baseline to 17 weeks|||participants|||Number
722292|NCT00315328|Secondary|Mean Visual Acuity in the Fellow Eye at 17 Weeks|Visual acuity was measured in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.|17 weeks|||ETDRS letter score||Standard Deviation|Mean
722293|NCT00315328|Secondary|Distribution of Visual Acuity in the Fellow Eye at 17 Weeks|Visual acuity was measured in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.|17 weeks|||participants|||Number
722294|NCT00315328|Primary|Mean Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks|"Visual acuity was measured at baseline and 17 weeks in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference between the scores at baseline and 17 weeks was calculated.
A positive difference indicates acuity was better at 17 weeks than at baseline; a negative difference indicates acuity was worse at 17 weeks."|Baseline to 17 weeks|||ETDRS letter score||Standard Deviation|Mean
722295|NCT00315328|Primary|Distribution of Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks|"Visual acuity was measured at baseline and 17 weeks in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference between the scores at baseline and 17 weeks was calculated.
A positive difference indicates acuity was better at 17 weeks than at baseline; a negative difference indicates acuity was worse at 17 weeks."|Baseline to 17 weeks|||participants|||Number
722296|NCT00315328|Primary|Mean Visual Acuity in the Amblyopic Eye at 17 Weeks|Visual acuity was measured in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.|17 weeks|||ETDRS letter score||Standard Deviation|Mean
722297|NCT00315328|Primary|Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks|Visual acuity was measured in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.|17 weeks|Primary analysis includes only patients who completed the 17 week exam between 13 and 26 weeks following randomization. No imputation was done if missed exam; analysis followed the intent to treat principle.||participants|||Number
722299|NCT00315328|Secondary|Amblyopia Treatment Index - Compliance (Moderate Amblyopia Only)|Questionnaire scores on the compliance subscale of the Amblyopia Treatment Index. Questions were evaluated on a likert type scale as strongly agree (5) to strongly disagree (1), with a higher number indicating worse response.|17 weeks|Number of subjects who completed the 17wk amblyopia treatment index questionnaire evaluating the impact of treatment on the child and family.||Units on a scale||Standard Deviation|Mean
722300|NCT00315328|Secondary|Amblyopia Treatment Index - Social Stigma (Moderate Amblyopia Only)|Questionnaire scores on the Social Stigma subscale of the Amblyopia Treatment Index. Questions were evaluated on a likert type scale as strongly agree (5) to strongly disagree (1), with a higher number indicating worse response.|17 weeks|Number of subjects who completed the 17wk amblyopia treatment index questionnaire evaluating the impact of treatment on the child and family.||Units on a scale||Standard Deviation|Mean
722301|NCT00315328|Secondary|Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia|"Stereoacuity is scored as seconds of arc with values of: <800, 800, 400, 200, 100, 60, 40. The lower the arc second value, the better the score (i.e. 40 arc sec is best stereoacuity; <800 is the worst). A change score was defined as the difference between baseline and outcome in score level (i.e. moving from 800 at baseline to 400 at outcome is one level change, moving from 800 to 200 is two levels, etc.) change in levels was categorized as within one level meaning change was -1, 0, or +1."|17 or 19 weeks|||Participants|||Number
722302|NCT00315328|Secondary|Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With Moderate Amblyopia From Strabismus Only or Combined Mechanism|The Randot Preschool Stereotest measures stereopsis from 800 to 40 seconds of arc on patients as young as 2 years of age. This Stereotest is designed as a matching game in which the patient matches pictures in a test booklet wearing special glasses. A subject can fail the pretest (not see any pictures) or can score >800 (the worst), 800, 400, 200, 100, 60, or 40 (the best) seconds of arc. If two shapes are identified correctly the patient progresses to the next lower stereoacuity level. A failed test occurs when the patient cannot identify any shapes.|17 or 19 weeks|||Participants|||Number
722303|NCT00315328|Secondary|Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Anisometropic Participants With Moderate Amblyopia Only|The Randot Preschool Stereotest measures stereopsis from 800 to 40 seconds of arc on patients as young as 2 years of age. This Stereotest is designed as a matching game in which the patient matches pictures in a test booklet wearing special glasses. A subject can fail the pretest (not see any pictures) or can score >800 (the worst), 800, 400, 200, 100, 60, or 40 (the best) seconds of arc. If two shapes are identified correctly the patient progresses to the next lower stereoacuity level. A failed test occurs when the patient cannot identify any shapes.|17 or 19 weeks|||Participants|||Number
722304|NCT00315328|Secondary|Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia|The Randot Preschool Stereotest measures stereopsis from 800 to 40 seconds of arc on patients as young as 2 years of age. This Stereotest is designed as a matching game in which the patient matches pictures in a test booklet wearing special glasses. A subject can fail the pretest (not see any pictures) or can score >800 (the worst), 800, 400, 200, 100, 60, or 40 (the best) seconds of arc. If two shapes are identified correctly the patient progresses to the next lower stereoacuity level. A failed test occurs when the patient cannot identify any shapes.|17 or 19 weeks|||Participants|||Number
722305|NCT00315341|Primary|Hepatic Safety|"Participants were categorized according liver transaminase (ALT, AST) levels in blood comparing the baseline sample to any and all subsequent samples in the following manner:
A: both ALT and AST started at less than or equal to two times the ULN and remained at two times or less ULN throughout the study
B: either ALT or AST started at less than or equal to 2 x ULN and at any point in study exceeded 2 x ULN
C: Either ALT or AST started > 2 x ULN, decreased (both ALT and AST) to < 2 x ULN, and remained < 2 x ULN
D: Either ALT or AST started > 2 x ULN and remained above 2 x ULN throughout the study"|24 Weeks|evaluable subjects stayed in treatment for 24 weeks and gave at least 4 blood samples for liver function tests during the treatment period||participants|||Number
722306|NCT00315445|Post-Hoc|"Sensitivity Analysis: Pain Right Now Change From Baseline to End of Treatment (Day 84) (Hybrid BOCF/LOCF)"|"Subjects were asked, “Please rate your pain by circling the one number (0–10) that tells how much pain you have right now.” Subjects rated their answers on a 0–10 ordinal scale from 0 = “No pain” to 10 = “Pain as bad as you can imagine it.”
This is a multiple imputation method that requires imputed changes from baseline to be stratified by discontinuation (D/C) reason. If subject D/C'd from study due to AE, the baseline observation was carried forward (BOCF). If subject D/C'd from study other than for AE, the last missing data prior to D/C of study drug was carried forward (LOCF)."|Baseline to day 84|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.
Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."||Units on a scale||Standard Error|Least Squares Mean
722307|NCT00315445|Post-Hoc|"Sensitivity Analysis: Pain on the Average Change From Baseline to End of Treatment (Day 84) (Hybrid BOCF/LOCF)"|"Subjects were asked, “Please rate your pain by circling the one number (0–10) that best describes your pain on the average since your last visit.” 0 = no pain and 10 = pain as bad as you can imagine it.
This is a multiple imputation method that requires imputed changes from baseline to be stratified by discontinuation (D/C) reason. If subject D/C'd due to AE, the baseline observation was carried forward (ie, BOCF method of imputation). If subject D/C'd other than for an AE, the last missing data prior to D/C of study drug was carried forward (ie, LOCF method of imputation)."|Baseline to day 84|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.
Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."||Units on a scale||Standard Error|Least Squares Mean
722317|NCT00315445|Secondary|Therapeutic Response - Investigator: Mean ± SEM (Day 84)(LOCF)|The therapeutic response was rated by the investigator. The assessment was completed by the investigator using a 0–3 ordinal scale from 0 = “No response” to 3 = “Marked response.”|Day 84|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.
Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."||Units on a scale||Standard Error|Mean
722308|NCT00315445|Post-Hoc|"Sensitivity Analysis: Pain Right Now Change From Baseline in the Maintenance Period (Days 21-84) (Hybrid BOCF/LOCF)"|"Subjects were asked, “Please rate your pain by circling the one number (0–10) that tells how much pain you have right now.” Subjects rated their answers on a 0–10 ordinal scale from 0 = “No pain” to 10 = “Pain as bad as you can imagine it.”
This is a multiple imputation method that requires imputed changes from baseline to be stratified by discontinuation (D/C) reason. If subject D/C'd from study due to AE, the baseline observation was carried forward (BOCF). If subject D/C'd from study other than for AE, the last missing data prior to D/C of study drug was carried forward (LOCF)."|Baseline to days 21-84|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.
Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."||Units on a scale||Standard Error|Least Squares Mean
722309|NCT00315445|Post-Hoc|"Sensitivity Analysis Pain on the Average Change From Baseline in the Maintenance Period (Days 21-84) (Hybrid BOCF/LOCF)"|"Subjects were asked, “Please rate your pain by circling the one number (0–10) that best describes your pain on the average since your last visit.” 0 = no pain and 10 = pain as bad as you can imagine it.
This is a multiple imputation method that requires imputed changes from baseline to be stratified by discontinuation (D/C) reason. If subject D/C'd due to AE, the baseline observation was carried forward (ie, BOCF method of imputation). If subject D/C'd other than for an AE, the last missing data prior to D/C of study drug was carried forward (ie, LOCF method of imputation)."|Baseline to days 21-84|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.
Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."||Units on a scale||Standard Error|Least Squares Mean
722310|NCT00315445|Post-Hoc|Sensitivity Analysis: “Pain Right Now” Change From Baseline in the Maintenance Period (Days 21–84), BOCF|Subjects were asked, “Please rate your pain by circling the one number (0–10) that tells how much pain you have right now.” Subjects rated their answers on a 0–10 ordinal scale from 0 = “No pain” to 10 = “Pain as bad as you can imagine it.” Primary back pain was measured.|Baseline to days 21-84|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.
Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."||Units on a scale||Standard Error|Least Squares Mean
722311|NCT00315445|Post-Hoc|Sensitivity Analysis: “Pain on the Average” Change From Baseline in the Maintenance Period (Days 21 - 84) Baseline Observation Carried Forward (BOCF)|Subjects were asked, “Please rate your pain by circling the one number (0–10) that best describes your pain on the average since your last visit.” 0 = no pain and 10 = pain as bad as you can imagine it.|Baseline to days 21 - 84|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.
Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."||Units on a scale||Standard Error|Least Squares Mean
722312|NCT00315445|Secondary|The Time to Discontinuation Due to Lack of Efficacy|Dropouts due to various reasons were summarized by counts and percentage. Cox proportional hazards regression was used to assess the treatment differences in time to dropout due to lack of efficacy. Clinically important covariates (including gender, age, race, weight, baseline pain, and previous opioid use) were incorporated into the model when statistically significant at P< .10, using a backward elimination procedure.|Time after dosing to dropout due to lack of efficacy|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.
Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn because the informed consent was never obtained and had no efficacy data."||Days||Inter-Quartile Range|Median
722313|NCT00315445|Secondary|Time to Stable Pain Management|"For each subject, time to stable pain management is defined as the first (post-baseline) time during the titration period when his/her diary pain was 4 or less (or at least 2 points lower than baseline) for 3 consecutive daily records or the pain on the average (at the day 7 or day 21 visit) was 4 or less (or at least 2 points lower than baseline)."|Start of study to day 21.|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.
Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."||Days||Inter-Quartile Range|Median
722314|NCT00315445|Secondary|Subject Satisfaction: Mean ± SEM (Day 84)(LOCF)|The subject assessed satisfaction with study drug. The assessment was completed by the subject using a 0–3 ordinal scale from 0 = “No response” to 3 = “Marked response.”|Day 84|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.
Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."||Units on a scale||Standard Error|Mean
722315|NCT00315445|Secondary|Subject Comparison to Prestudy Analgesic: Mean ± SEM (Day 84)(LOCF)|The subject compared study drug treatment to prestudy analgesic. The assessment was completed by the subject using a 0–2 ordinal scale from 0 = “Worse than prestudy medicine” to 2 = “Better than prestudy medicine.”|Day 84|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.
Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."||Units on a scale||Standard Error|Mean
722316|NCT00315445|Secondary|Therapeutic Response - Subject: Mean ± SEM (Day 84) (LOCF)|The therapeutic response was rated by the subject. The assessment was completed by the subject using a 0–3 ordinal scale from 0 = “No response” to 3 = “Marked response.”|Day 84|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.
Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."||Units on a scale||Standard Error|Mean
722346|NCT00315705|Secondary|Time to Remission for Participants Who Had a Response in Phase 2|The weeks between start of intervention and remission as assessed by the investigator in Phase 2. Participants who had a complete remission (CR) or complete remission with the absence of total platelet recovery (CRp) are included.|up to 8 weeks (Phase 2 portion of study)|Participants in phase 2 who had an overall remission.||weeks||Standard Deviation|Mean
722318|NCT00315445|Secondary|"Mental Health (MOS SF-36):Mean Percent ± SEM at Day 84 (LOCF)"|"The MOS Short-Form Health Survey assesses 8 categories of functionality through 36 individual questions. Mental Health is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic."|Day 84|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.
Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."||Units on a scale||Standard Error|Mean
722319|NCT00315445|Secondary|"Emotional Role (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)"|"The MOS Short-Form Health Survey assesses 8 categories of functionality through 36 individual questions. Emotional Role is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic."|Day 84|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.
Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."||Units on a scale||Standard Error|Mean
722320|NCT00315445|Secondary|"Social Functioning (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)"|"The MOS Short-Form Health Survey assesses 8 categories of functionality through 36 individual questions. Social Functioning is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic."|Day 84|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.
Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."||Units on a scale||Standard Error|Mean
722321|NCT00315445|Secondary|"Vitality (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)"|"The MOS Short-Form Health Survey assesses 8 categories of functionality through 36 individual questions. Vitality is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic. The mean scores were analyzed."|Day 84|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.
Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."||Units on a scale||Standard Error|Mean
722322|NCT00315445|Secondary|"General Health (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)"|"The MOS Short-Form Health Survey assesses 8 categories of functionality through 36 individual questions. General Health is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at clinic. The mean scores were analyzed."|Day 84|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.
Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."||Units on a scale||Standard Error|Mean
722323|NCT00315445|Secondary|"Bodily Pain (MOS SF-36): Mean Percent at Day 84 (LOCF)"|"The MOS Short-Form Health Survey assesses 8 categories of functionality through 36 individual questions. Bodily Pain is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic. The mean scores were analyzed."|Day 84|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.
Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."||Units on a scale||Standard Error|Mean
722324|NCT00315445|Primary|Pain Right Now, Mean Change From Baseline, Days 21–84 (LOCF)|Subjects were asked, “Please rate your pain by circling the one number (0–10) that tells how much pain you have right now.” Subjects rated their answers on a 0–10 ordinal scale from 0 = “No pain” to 10 = “Pain as bad as you can imagine it.” Pain right now is presented as the LSmean [change from baseline] (SE).|Assessed at baseline day 1 and days 21, 30, 45, 60, 75, and 84, and, if applicable, at early termination.|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.
Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."||Units on a scale||Standard Error|Least Squares Mean
722325|NCT00315445|Secondary|"Physical Role Scale (MOS SF-36): Mean Percent ± SEM at Day 84(LOCF)"|"The Medical Outcomes Survey Short-Form-36 health survey assesses 8 categories of functionality through 36 individual questions. Physical Role is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic. The mean scores were analyzed."|Day 84|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.
Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."||Units on a scale||Standard Error|Mean
722326|NCT00315445|Secondary|"Physical Functioning Scale of the Medical Outcomes Survey (MOS) 36 Item Short-Form Health Survey (SF-36): Mean Percent ± Standard Error of the Mean (SEM) at Day 84 (LOCF)"|"The Medical Outcomes Survey (MOS) Short-Form-36 Health Survey (SF-36) assesses 8 categories of functionality through 36 individual questions. Physical Functioning is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic. The mean scores were analyzed."|Day 84, or, if applicable, at early termination|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.
Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."||Units on a scale||Standard Error|Mean
722360|NCT00315731|Secondary|Duration of Response|Duration of response is defined as the time from first documented response (CR, CRu, or PR) until disease progression.|Week 7 to Week 260 post treatment|ITT-E Population. Only participants who had a response (CR, CRu, or PR) were evaluated.||months||95% Confidence Interval|Median
723430|NCT00330460|Secondary|Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|12 months|||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
722327|NCT00315445|Primary|Pain on the Average, Mean Change From Baseline Days 21–84 (Last Observation Carried Forward [LOCF])|Subjects were asked, “Please rate your pain by circling the one number (0–10) that best describes your pain on the average since your last visit.” 0 = no pain and 10 = pain as bad as you can imagine it.|On baseline day 1 and days 21, 30, 45, 60, 75, and 84, and, if applicable, at early termination.|All 134 subjects randomized and received study drug were included in the intent-to-treat (ITT) and safety analyses. ITT Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from study because the informed consent was never obtained. This subject had no efficacy data but was included the analysis of discontinuation due to lack of efficacy.||Units on a scale||Standard Error|Least Squares Mean
722328|NCT00315458|Primary|Number of Participants With Adverse Events (AEs) as a Measure of Safety|For the Run-in and double-blind phases of the study, the focus of this study was changed before unblinding to a safety study due to early termination and having enrolled only 35% of the planned sample size. Therefore, the safety data is presented for the run-in and double-blind and overall exposure to BTDS, which includes the extension phase.|483 days|The full analysis population consisted of all subjects who were randomized into the double-blind phase and received at least 1 dose of double-blind treatment.||participants|||Number
722329|NCT00315588|Secondary|Reduction in Severe Hypoglycemia, Improvement in Hypoglycemia Awareness|Elimination or reduction in the incidence of hypoglycemic coma or unawareness|1 years|||Participants|||Count of Participants
722330|NCT00315588|Secondary|Reduction of Insulin Requirements|Reduction in insulin requirements in those patients who do not achieve insulin independence|1year|||Participants|||Count of Participants
722331|NCT00315588|Secondary|Stimulated C-peptide Greater Than 0.5 ng/ml|Partial graft function, as evidenced by basal C-peptide greater than 0.5 ng/ml|1 year|||Participants|||Count of Participants
722332|NCT00315588|Primary|Insulin Independence.|Number of Participants who Achieved Insulin Independence at 1 Year|1 year|||Participants|||Count of Participants
722333|NCT00315614|Secondary|Number of Subjects With Reduction of Severe Hypoglycemia and Improvement in Hypoglycemia Awareness|Number of subjects with reduction of episodes of severe hypoglycemia and the presence of awareness of hypoglycemia|for the duration of islet graft function|||Participants|||Count of Participants
722334|NCT00315614|Secondary|Number of Subjects With Basal C-peptide Greater Than 0.5 ng/ml|Number of subjects with basal C-peptide greater than 0.5 ng/ml prior to weaning of immunosuppression;|for the duration of islet graft function|||Participants|||Count of Participants
722335|NCT00315614|Primary|A Reduction or Absence of Rejection Episodes|Number of rejection episodes after transplantation. Immunosuppression was never discontinued. Patients elected to move to other trials to receive additional islet infusions. Since immunosuppression was never discontinued we were not able to evaluate the primary endpoint.|for the duration of islet graft function|IImmunosuppression was never discontinued. Patients elected to move to other trials to receive additional islet infusions. Since immunosuppression was never discontinued we were not able to evaluate the primary endpoint. No data available to analyze.|||||
722336|NCT00315614|Primary|The Achievement of Persistent Islet Function Following Cessation of Immunosuppression.|Immunosuppression was never discontinued. Patients elected to move to other trials to receive additional islet infusions. Since immunosuppression was never discontinued we were not able to evaluate the primary endpoint.|for the duration of islet graft function|IImmunosuppression was never discontinued. Patients elected to move to other trials to receive additional islet infusions. Since immunosuppression was never discontinued we were not able to evaluate the primary endpoint. No data available to analyze.|||||
722337|NCT00315627|Secondary|Restoration of Hypoglycemia Awareness 1 Year After Transplantation|The number of subjects with restoration of hypoglycemia awareness 1 year after islet transplantation|1 year|||Participants|||Count of Participants
722338|NCT00315627|Secondary|Elimination of Severe Hypoglycemia|The number of subjects with severe hypoglycemia after transplantation|1 year|||Participants|||Count of Participants
722339|NCT00315627|Secondary|Improvement in Metabolic Control as Evidenced by Hemoglobin A1c < 6.5%|Number of subjects with a hemoglobin A1c < 6.5% at 1year after islet transplantation|1 year|||Participants|||Count of Participants
722340|NCT00315627|Secondary|Islet Allograft Function|Number of subjects with basal C-peptide greater than 0.5 ng/ml|1 year|||Participants|||Count of Participants
722341|NCT00315627|Primary|Measurement of Glycemic Control by HbA1c and Prevention of Severe Hypoglycemia|Number of subjects at 1 year with HbA1c < 6.5% and absence of severe hypoglycemia|1 year|||participants|||Number
722342|NCT00315705|Secondary|Kaplan Meier Estimates of Overall Survival (OS) for Participants in Phase 2|Overall survival is defined as the time from date of first administration of study interventions until date of death, plus one day. For summary purposes, results are presented as weeks.|Up to 2 years (Phase 2 portion of study)|All phase 2 participants. Data are censored at date of last known follow-up visit.||weeks||95% Confidence Interval|Median
722343|NCT00315705|Secondary|Number of Participants With 4-month Event Free Survival in Phase 2|Number of participants with event-free survival at four months post first dose of therapy. A participant is considered event-free if at month 4 they have not died or had a response assessment confirming a relapse.|4 months (Phase 2 portion of study)|All participants||participants|||Number
722344|NCT00315705|Secondary|Kaplan Meier Estimates of Event-free Survival (EFS) for Participants in Phase 2|Event-free survival (EFS) is defined as the time from date of first administration of study interventions until the earliest of the following: date of death or date of first response assessment confirming relapse or date of final response assessment which fails to confirm response, plus one day. For summary purposes, results are presented as weeks.|Up to 2 years (Phase 2 portion of study)|All phase 2 participants. Data are censored at date of last known follow-up visit.||weeks||95% Confidence Interval|Median
722345|NCT00315705|Secondary|Kaplan Meier Estimate of Duration of Remission (DOR) for Participants Who Achieved Overall Remission (OR) in Phase 2|Duration of response is the time from the first objective measurement of complete response (CR) or complete response with the absence of total platelet recovery (CRp) to the date of first objective documentation of disease relapse or death due to any cause, plus one day. For summary purposes, results are presented as weeks.|Up to 2 years (Phase 2 portion of study)|Phase 2 participants who achieved overall remission. Data are censored at date of last known follow-up visit.||weeks||95% Confidence Interval|Median
723814|NCT00333801|Secondary|Employment Outcomes (Weeks Competitively Employed)|Number of weeks employed for any time in a competitive job (not set-aside job)|one year|All randomized participants (intent-to-treat)||weeks||Standard Deviation|Mean
722347|NCT00315705|Secondary|Summary of Participants With Adverse Events (AEs) in Phase 2|Number of participants with AEs that occurred during treatment and follow-up period (45 days after last cycle). Drug-related AEs and SAEs were followed until resolved or mutually agreed by the investigator and Genzyme to discontinue reporting. AEs were classified by the investigator according to severity (graded using National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 3.0) and relationship to study drug. The severity scale is: > Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death related to AE|Up to 9.5 months (Phase 2 portion of study)|All phase 2 participants||participants|||Number
722348|NCT00315705|Primary|Percentage of Participants Achieving A Response Over the First Two Treatment Cycles in Phase 2|Response categories 1) complete remission (CR): without circulating blasts or extramedullary disease, bone marrow (BM) with <5% blasts, and platelet (plt)/ANC recovery: ≥75/ ≥0.75 [x 10^9/L] 2) CR in absence of plt recovery (CRp): plt ≥20 to <75 x 10^9/L 3) partial remission (PR): no circulating blasts, appearance of normal hematopoietic progenitors, and either a BM with ≥5% and ≤25% blasts with recovery of plts/ANC or a BM with <5% blasts not meeting CR/CRp definition 4) Overall remission (OR): CR+CRp 5) Any response: CR+CRp+PR.|Approximately 28-56 days (Phase 2 portion of study)|All phase 2 participants||percentage of total participants|||Number
722349|NCT00315705|Secondary|Kaplan Meier Estimates of Overall Survival (OS) for Participants in Phase 1|Overall survival is defined as the time from date of first administration of study interventions until date of death, plus one day. For summary purposes, results are presented as weeks.|Up to 2 years (Phase 1 portion of study)|All phase 1 participants||weeks||95% Confidence Interval|Median
722350|NCT00315705|Secondary|Number of Participants With 4-month Event Free Survival in Phase 1|Number of participants with event-free survival at four months post first dose of therapy. A participant is considered event-free if at month 4 they have not died or had a response assessment confirming a relapse.|4 months (Phase I portion of study)|All participants||participants|||Number
722351|NCT00315705|Secondary|Kaplan Meier Estimates of Event-free Survival (EFS) for Participants in Phase 1|Event-free survival (EFS) is defined as the time from date of first administration of study interventions until the earliest of the following: date of death or date of first response assessment confirming relapse or date of final response assessment which fails to confirm response, plus one day. For summary purposes, results are presented as weeks.|Up to 2 years (Phase 1 portion of study)|All phase 1 participants. Data are censored at date of last known follow-up visit.||weeks||95% Confidence Interval|Median
722352|NCT00315705|Secondary|Kaplan Meier Estimate of Duration of Remission (DOR) for Participants Who Achieved Overall Remission (OR) in Phase 1|Duration of response is the time from the first objective measurement of complete response (CR) or complete response with the absence of total platelet recovery (CRp) to the date of first objective documentation of disease relapse or death due to any cause, plus one day. For summary purposes, results are presented as weeks.|Up to 2 years (Phase 1 portion of study)|Phase 1 participants who achieved overall remission. Data are censored at date of last known follow-up visit.||weeks||95% Confidence Interval|Median
722353|NCT00315705|Secondary|Time to Remission for Participants Who Had a Response in Phase 1|The weeks between start of intervention and remission as assessed by the investigator in Phase 1. Participants who had a complete remission (CR) or complete remission with the absence of total platelet recovery (CRp) are included.|up to 8 weeks (Phase 1 portion of study)|Participants in phase 1 who had an overall remission.||weeks||Standard Deviation|Mean
722354|NCT00315705|Secondary|Percentage of Participants Achieving A Response Over the First Two Treatment Cycles in Phase 1|Response categories 1) complete remission (CR): without circulating blasts or extramedullary disease, bone marrow (BM) with <5% blasts, and platelet (plt)/ANC recovery: ALL ≥75/ ≥0.75 [x 10^9/L]; AML ≥100/ ≥1.0 [x 10^9/L] 2) CR in absence of plt recovery (CRp): ALL plt ≥20 to <75 x 10^9/L; AML plt ≥20 to <100 x 10^9/L 3) partial remission (PR): no circulating blasts, appearance of normal hematopoietic progenitors, and either a BM with ≥5% and ≤25% blasts with recovery of plts/ANC or a BM with <5% blasts not meeting CR/CRp definition 4) Overall remission (OR): CR+CRp 5) Any response: CR+CRp+PR.|Approximately 2 months (Phase 1 portion of study)|All phase 1 participants||percentage of total participants|||Number
722355|NCT00315705|Secondary|Summary of Participants With Adverse Events (AEs) in Phase 1|Number of participants with AEs that occurred during treatment and follow-up period (45 days after last cycle). Drug-related AEs and SAEs were followed until resolved or mutually agreed by the investigator and Genzyme to discontinue reporting. AEs were classified by the investigator according to severity (graded using National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 3.0) and relationship to study drug. The severity scale is: > Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death related to AE|Up to 9.5 months (Phase 1 portion of study)|All phase 1 participants||participants|||Number
722356|NCT00315705|Primary|Participants With Dose Limiting Toxicity in Phase 1|The number of participants in each cohort that had dose limiting toxicity is summarized. Toxicities were reviewed by an independent Data Safety Monitoring Board (DSMB) who determined if additional participants should be added to the cohort and the criteria for escalating to the next cohort.|Up to Day 42 (Phase 1 portion of study)|All phase 1 participants||participants|||Number
722357|NCT00315705|Primary|Maximum Tolerated Dose (MTD) in Phase 1|"The MTD was to be the highest dose level of clofarabine in combination with etoposide and cyclophosphamide that caused <= 1 of 6 participants to experience a dose limiting toxicity (DLT) with the next higher dose level having at least 2 of 3 or 2 of 6 participants experiencing a DLT. The MTD would be used as the recommended phase 2 dose (RP2D). If the MTD could not be determined, then the target dose of clofarabine 40 mg/m^2, etoposide 100 mg/m^2 and cyclophosphamide 440 mg/m^2 as taken by Cohort 5 was to become the RP2D.
The rating scale used is 0 = not the MTD, 1 = the MTD."|Up to Day 42 (Phase 1 portion of study)|All phase 1 participants||units on a scale|||Number
722358|NCT00315731|Secondary|Overall Survival|Time to death is defined as the time from the dosimetric dose to the date of death.|Week 7 to Week 260 post treatment|ITT-E Population||months||95% Confidence Interval|Median
722359|NCT00315731|Secondary|Progression-free Survival|Progression-free survival, or time to progression, is defined as the time from the dosimetric dose to the first documented disease progression (PD) or death. PD is defined as a >= 50% increase from nadir in the SPPD for all measurable disease.|Week 7 to Week 260 post treatment|ITT-E Population||months||95% Confidence Interval|Median
722361|NCT00315731|Secondary|Percentage of Participants Evaluable for Confirmed Response With Complete Response (CR), CR Unconfirmed (CRu), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD)|Evaluation based on the Int'l Workshop to Standardize Response Criteria for non-Hodgkin's Lymphoma (NHL). CR, complete disappearance of all detectable clinical/radiographic evidence of disease, disappearance of all disease-related symptoms if present before therapy, and normalization of biochemical abnormalities definitely assignable to NHL. CRu, complete response unconfirmed, included complete disappearance of all detectable clinical and radiographic evidence of disease, disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities definitely assignable to NHL. PR, >=50% decrease in sum of perpendicular diameters (SPD) of all measurable lesions determined at baseline. SD, less than a PR but not progressive disease (>=50% increase from nadir in SPD for all measurable disease or the appearance of any new lesion that was >=1.4 cm x 1.4 cm by radiographic evaluation or >=1.0 cm by palpation per physical examination).|From Baseline up to 99 Months|ITT-E Population. The individual categories for confirmed CR, confirmed CRu, etc. counts those participants who had their response confirmed by the exact same response, not those who had their response confirmed by a better response (for example, Cru to CR; PR to CR; PR to CRU; etc.).||percentage of participants|||Number
722362|NCT00315731|Secondary|Number of Participants With Expected Distribution of Radioactivity in the Circulatory System Compared With Uptake by Other Organs.|Expected biodistribution (images): most radioactivity (RA) in blood pool, with uptake in normal liver and spleen less than the heart. Later time points, RA in blood pool decrease and uptake in normal liver and spleen decrease. Images may show uptake by the thyroid gland, kidneys, urinary bladder, and lungs. Altered biodistribution: Blood pool not visualized or diffuse, intense uptake in the liver and/or spleen, or uptake suggestive of urinary obstruction, diffuse lung uptake greater than the blood pool|0 to 7 days from dosimetric dose (given only once on Day 0)|All participants who were considered evaluable for dosimetric assessment per protocol eligibility criteria and had gamma camera scans from at least 4 time points.||participants|||Number
722363|NCT00315731|Secondary|Mean Absorbed Dose in the Source Organs and the Target Organs|The radiation absorbed dose to source organs were determined with Organ Level Internal Dose Assessment/Exponential Modeling (OLINDA/EXM) software using residence times directly determined by an independent reviewer for kidneys, liver, lungs, spleen, urinary bladder, and total body; the radiation absorbed dose for the remaining target organs was based on a mathematical model used to calculate source organ radiation dose estimates using the same OLINDA/EXM software. OLINDA/EXM is a registered proprietary computer program.|0 to 7 days from dosimetric dose|All participants who were considered evaluable for dosimetric assessment per protocol eligibility criteria and had gamma camera scans from at least 4 time points. Different numbers of participants were analyzed for different organs (represented by n=X, X in the category titles).||mGy/MBq||95% Confidence Interval|Mean
722364|NCT00315731|Secondary|Mean Residence Times From Day 0 to Day 7|Whole body images from anterior and posterior gamma camera scans were collected to assess dosimetry. Assessment of organ dosimetry required gamma camera scans from at least 4 time points. Nuclear medicine reviewers conducted a visual examination of the gamma camera scans and calculated the total body residence times. Residence time is calculated from the rate of total body clearance of iodine I-131 radioactivity during the dosimetric dose. Residence time is a measure of how long the drug resides in the body.|0 to 7 days from dosimetric dose (given only once on Day 0)|All participants who were considered evaluable for dosimetric assessment per protocol eligibility criteria and had gamma camera scans from at least 4 time points. Different numbers of participants were analyzed for different organs (represented by n=X, X in the category titles).||hours||95% Confidence Interval|Mean
722365|NCT00315731|Secondary|Maximum Concentration (Cmax) Values|Maximum observed concentration from time zero (end of the dosimetric dose infusion) to 7 days after the end of the infusion. Unit: %ID/mL, where %ID/mL is the percentage of the injected dose per milliliter blood. Cmax is the highest drug concentration in the blood after the dose.|0 to 7 days from dosimetric dose (given only once on Day 0)|All participants considered as evaluable for pharmacokinetic assessment per protocol criteria.||%ID/mL||95% Confidence Interval|Geometric Mean
722366|NCT00315731|Secondary|Area Under the Curve (AUC) at 0 to Infinity (Extrapolated)|Ratio and 90% CI for AUC (0 to infinity) after dosimetric dose of fission-derived 131I-tositumomab to historical data from tellurium derived 131I-tositumomab. AUC measures how much drug is in the blood over time after the dose is given.|0 to infinity h from dosimetric dose (given only once on Day 0)|All participants considered as evaluable for pharmacokinetic assessment per protocol criteria.||%ID.h/mL||95% Confidence Interval|Geometric Mean
722367|NCT00315731|Secondary|Area Under the Curve (AUC) at 0 to 168 Hours|Ratio and 90% confidence interval for AUC(0-168) after dosimetric dose of fission-derived 131I-tositumomab to historical data from tellurium-derived 131I-tositumomab. AUC measures how much drug is in the blood over time after the dose.|0-168 h from dosimetric dose (given only once on Day 0)|All participants considered as evaluable for pharmacokinetic assessment per protocol criteria.||%ID.h/mL||95% Confidence Interval|Geometric Mean
722368|NCT00315731|Secondary|Area Under the Curve (AUC) at 0 to 120 Hours|Area under the concentration-time curve from time 0 to 120 hours after the end of the dosimetric dose infusion. Unit: %ID.h/mL, where %ID/mL is the percentage of the injected dose per milliliter blood. AUC measures how much drug is in the system over time after infusion.|0-120 hours from dosimetric dose (given only once on Day 0)|All participants considered as evaluable for pharmacokinetic assessment per protocol criteria.||%ID.h/mL||95% Confidence Interval|Geometric Mean
722369|NCT00315731|Primary|Volume of Distribution at Steady State (Vss)|Volume of distribution at steady state of 131I-tositumomab. Volume of distribution measures how much the drug spreads through the body after the dose.|0 to 7 days from dosimetric dose given only once on Day 0|All participants considered as evaluable for pharmacokinetic assessment per protocol criteria.||milliliters (ml)||95% Confidence Interval|Geometric Mean
722370|NCT00315731|Primary|Clearance (CL) Values|Clearance of 131I-tositumomab after intravenous administration. The clearance of a drug measures the rate at which the drug is removed from the body after the dose.|0 to 7 days from dosimetric dose given only once on Day 0|All participants considered as evaluable for pharmacokinetic assessment per protocol criteria.||milliliters per hour (ml/hr)||95% Confidence Interval|Geometric Mean
722689|NCT00326898|Other Pre-specified|The Association Between Tumor and Genetic Polymorphisms and Disease-free Survival||Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry||||||
722371|NCT00315731|Primary|Terminal Phase Half-life (t½)|The terminal phase half-life of 131 I tositumomab in hours. Half-life measures how long it takes for the concentration of drug in the blood to decrease by half.|0 to 7 days from dosimetric dose (given only once on Day 0)|All participants considered as evaluable for pharmacokinetic assessment per protocol criteria.||hours||95% Confidence Interval|Geometric Mean
722372|NCT00315731|Primary|Maximum Concentration (Cmax) Values|Cmax is the maximum observed 131I-tositumomab concentration from time zero (end of the dosimetric dose infusion) to 7 days after the end of the infusion. Unit: %ID/mL, where %ID/mL is the percentage of the injected dose per milliliter blood. Cmax is the highest drug concentration in the blood after infusion.|0 to 7 days from dosimetric dose (given only once on Day 0)|All participants considered as evaluable for pharmacokinetic assessment per protocol criteria.||%ID/mL||95% Confidence Interval|Geometric Mean
722373|NCT00315731|Primary|Area Under the Curve (AUC) at 0 to 120, 0 to 168, and 0 to Infinity Hours|Area under the concentration-time curve for 131I-tositumomab from time 0 to 120, 0 to 168, and time 0 to infinity hours (extrapolated), after the end of the dosimetric dose infusion. Unit: %ID.h/mL, where %ID/mL is the percentage of the injected dose per milliliter blood. AUC measures how much drug is in the system over time after infusion.|0-120, 0-168, and 0-infinity hours from dosimetric dose (given only once on Day 0)|All participants considered as evaluable for pharmacokinetic assessment per protocol criteria.||%ID.h/mL||95% Confidence Interval|Geometric Mean
722374|NCT00315822|Primary|Proportion of Patients With Collapsed Composite Complications|Proportion of patients with the collapsed composite complications, including surgical wound infection, anastomotic leak, intra-abdominal abscess, peritonitis without leak, sepsis, wound dehiscence, intestinal obstruction, bleeding, and death during 60 days after surgery|60 days after surgery|||Participants|||Count of Participants
722375|NCT00315939|Primary|Frequency of Severe Hypoglycemia|"Severe hypoglycemia (SH) was defined to subjects as blood glucose so low that you could not treat yourself because you were stuporous or unconscious."|1 year (each level lasted 3 months)|"All 120 participants were analyzed; data for subjects who dropped out during the study were handled according to the intention-to-treat principle, using dropout as a factor and adjusting significance levels accordingly. Below data for the 97 participants who completed the 1-year protocol are shown."||episodes/month/person|||Number
722376|NCT00315939|Primary|Hemoglobin A1c||1 year (each level lasted 3 months)|All 120 participants were analyzed; data for subjects who dropped out during the study were handled according to the intention-to-treat principle, using “dropout” as a factor and adjusting significance levels accordingly. Below data for the 97 participants who completed the 1-year protocol are shown.||percentage of glycated hemoglobin||Standard Deviation|Mean
722377|NCT00316004|Secondary|Discharge Disposition|Disposition of patient at the time of discharge from the acute care hospital|Duration of hospital stay|Number of participants analyzed in each group is the actual number analyzed, which does not include participants with one of the following: 1. prehospital death; 2. transfer to another hospital without IRB approval; or 3. patient, family member, or legally authorized representative refused consent and was withdrawn from the study.||Participants|||Number
722378|NCT00316004|Secondary|Packed Red Blood Cells (PRBC) First 24 Hours|The average (mean) number of units of packed red blood cells (PRBC) transfused in the first 24 hours following the time of the 911 call in each group.|First 24 hours from the time dispatch received 911 call|An analysis of this secondary outcome was done for all participants assigned to each of the three groups who had relevant data.||Unit of PRBC||Standard Deviation|Mean
722379|NCT00316004|Secondary|Total Fluids in First 24 Hours|The average (mean) total amount of intravenous (IV) fluids given in the pre-hospital setting and the hospital setting in the first 24 hours following the time of the 911 call|First 24 hours from the time dispatch received 911 call|An analysis of this secondary outcome was done for all participants assigned to each of the three groups who had relevant data.||Liters||Standard Deviation|Mean
722380|NCT00316004|Secondary|Presence of Nosocomial Infections|Includes one or more nosocomial infections diagnosed during the hospital stay but not present on admission to the hospital from the following list: pneumonia, bloodstream infection, urinary tract infection, and/or wound infection|From day of injury to 28 days after injury|"An analysis of this secondary outcome was done for all participants assigned to each of the three groups who had relevant data. Percentages were based on population at risk.
Row 1 nosocomial infections; Row 2 pneumonia; Row 3 bloodstream infections; Row 4 urinary tract infections; and Row 5 wound infections"||Diagnoses|||Number
722381|NCT00316004|Secondary|Days Alive Out of the Hospital Through Day 28|The number of days the patient is alive and no longer an inpatient in the hospital through day 28|From day of injury to 28 days after injury|Number of participants analyzed in each group is the actual number analyzed, which does not include participants with one of the following: 1. prehospital death; 2. transfer to another hospital without IRB approval; or 3. patient, family member, or legally authorized representative refused consent and was withdrawn from the study.||Days||Standard Deviation|Mean
722382|NCT00316004|Secondary|Days Alive Out of the Intensive Care Unit (ICU) Through Day 28|The number of days the patient is alive and not being cared for in the intensive care unit|From day of injury to 28 days after injury|Number of participants analyzed in each group is the actual number analyzed, which does not include participants with one of the following: 1. prehospital death; 2. transfer to another hospital without IRB approval; or 3. patient, family member, or legally authorized representative refused consent and was withdrawn from the study.||Days||Standard Deviation|Mean
722383|NCT00316004|Secondary|Ventilator-free Days Through Day 28|"The number of days beginning with the day of 911 call counted as Day 0 through day 28 that the patient did not require mechanical ventilation. Deaths are assigned the worst score (0)."|From day of injury to 28 days after injury|Number of participants analyzed in each group is the actual number analyzed, which does not include participants with one of the following: 1. prehospital death; 2. transfer to another hospital without IRB approval; or 3. patient, family member, or legally authorized representative refused consent and was withdrawn from the study.||Days||Standard Deviation|Mean
722412|NCT00316017|Secondary|Worst Multiple Organ Dysfunction Score (MODS) Mean Through Day 28|"Multiple Organ Dysfunction Score is described as:
Six organ systems were chosen, and a score of 0-4 allotted for each organ according to function (0 being normal function through to 4 for most severe dysfunction) with a maximum score of 24. The worst score based on available data (missing values were assumed normal) in each 24-hour period is taken for calculation of the aggregate score."|28 days from time of ED arrival|||Scores on a scale||Standard Deviation|Mean
722384|NCT00316004|Secondary|Worst Multiple Organ Dysfunction Score (MODS) Through Day 28|Multiple Organ Dysfunction Score is described as: Six organ systems were chosen: 1) respiratory; 2) renal; 3) hepatic; 4) cardiovascular; 5) hematologic; and 6) neurologica. A score of 0-4 was allotted for each organ according to function (0 being normal function through 4 for most severe dysfunction) with a maximum score of 24. The worst score based on available data (missing values were assumed normal) was taken for calculation of the aggregate score. Deaths are assigned the worst score (24).|From day of injury to 28 days after injury|Number of participants analyzed in each group is the actual number analyzed, which does not include participants with one of the following: 1. prehospital death; 2. transfer to another hospital without IRB approval; or 3. patient, family member, or legally authorized representative refused consent and was withdrawn from the study.||Scores on a scale||Standard Deviation|Mean
722385|NCT00316004|Secondary|Acute Respiratory Distress Syndrome (ARDS)-Free Survival to Day 28|The patient is alive and free of ARDS from the date of injury through to the 28th day following injury. The diagnosis of ARDS is based on standard criteria: a) hypoxia with a ratio of arterial oxygen pressure to percent oxygen delivered of less than 200; b) bilateral infiltrates on chest X-ray; and c) clinical evidence of increased left atrial pressure or pulmonary artery wedge pressure of greater than 18 mmHg.|From day of injury to 28 days after injury|Number of participants analyzed in each group is the actual number analyzed, which does not include participants with one of the following: 1. prehospital death; 2. transfer to another hospital without IRB approval; or 3. patient, family member, or legally authorized representative refused consent and was withdrawn from the study.||Participants|||Number
722386|NCT00316004|Secondary|Survival at Hospital Discharge up to 6 Months From Date of Injury|The patient who is admitted to the hospital alive after injury and is alive when discharged from the hospital up to 6 months from the date of injury.|Date of hospital discharge up to 6 months from date of injury|An analysis of this secondary outcome was done for all participants assigned to each of the three groups who had relevant data.||Participants|||Number
722387|NCT00316004|Secondary|28 Day Survival|The patient who is admitted to the hospital after injury and is alive on the 28th day after injury. For 28-day survival, patients with missing 28-day vital status who were known to be discharged alive prior to 28 days were assumed to be alive at day 28.|28 days after injury|An analysis of this secondary outcome was done for all participants assigned to each of the three groups who did not refuse or were lost to follow-up prior to discharge.||Participants|||Number
722388|NCT00316004|Secondary|Disability Rating Score (DRS) Categories of Disability|The DRS is an additional measure of neurological outcome that categorizes the patient's level of disability on a scale of 0 to 29, with 0 indicating no disability to 29 indicating extreme vegetative state. To adjust for 15% of subjects with absent 6-month DRS data, an analysis using 20 hot deck imputations for the 6-month DRS was done using data from patients who were discharged alive based on 1-month post discharge DRS data or discharge DRS (if 1-month post discharge data were not available), length of hospital stay, and treatment group.|6 months after injury|To adjust for 15% of subjects with absent 6-month DRS data, an analysis using 20 hot deck imputations for the 6-month DRS was done using data from patients who were discharged alive based on 1-month post discharge DRS data or discharge DRS (if 1-month post discharge data were not available), length of hospital stay, and treatment group.||Participants (with imputed values)|||Number
722389|NCT00316004|Secondary|Subgroup of Participants With Head Abbreviated Injury Scores (AIS) Greater Than or Equal to 2 (Head AIS≥2) Assessed to Have Glasgow Outcome Scale-Extended (GOSE)≤4 at 6 Months: Imputed Analysis|The Abbreviated Injury Scale (AIS) ranks injuries on a scale of 1 to 6, with 1 being minor, 2 moderate, 3 serious, 4 severe, 5 critical and 6 an unsurvivable injury. A priori secondary analyses included the subgroup of participants in each intervention group with a head AIS≥2, which is a diagnostic indicator of moderate to lethal head injury. Of this subset of participants with AIS≥2, a second subset of participants with a GOSE≤4 at the 6 month follow up was analyzed. GOSE≤4 represents Upper Severe Disability or worse outcomes. 15% of subjects required imputation analysis for 6-month GOSE.|6 months after injury|To adjust for 15% of subjects with absent 6-month GOSE data, an analysis using 20 hot deck imputations for the 6-month GOSE was done using data from patients who were discharged alive based on 1-month post discharge GOSE data or discharge GOSE (if 1-month post discharge data were not available), length of hospital stay, and treatment group.||Participants (with imputed values)|||Number
722390|NCT00316004|Primary|Glasgow Outcome Scale-Extended (GOSE)≤4 at 6 Months: Imputed Analysis|Glasgow outcome score extended (GOSE) contains 8 categories: 1. Dead, 2. Vegetative State, 3. Lower Severe Disability, 4. Upper Severe Disability, 5. Lower Moderate Disability, 6. Upper Moderate Disability, 7. Lower Good Recovery and 8. Upper Good Recovery. To adjust for 15% of subjects with absent 6-month GOSE data, an analysis using 20 hot deck imputations for the 6-month GOSE was done using data from patients who were discharged alive based on 1-month post discharge GOSE data or discharge GOSE (if 1-month post discharge data were not available), length of hospital stay, and treatment group.|6 months after injury|To adjust for 15% of subjects with absent 6-month GOSE data, an analysis using 20 hot deck imputations for the 6-month GOSE was done using data from patients who were discharged alive based on 1-month post discharge GOSE data or discharge GOSE (if 1-month post discharge data were not available), length of hospital stay, and treatment group.||Participants (with imputed values)|||Number
722391|NCT00316004|Secondary|Subgroup of Participants With Head Abbreviated Injury Scores (AIS) Greater Than or Equal to 4 (Head AIS≥4) Assessed to Have Glasgow Outcome Scale-Extended (GOSE)≤4 at 6 Months: Imputed Analysis|The Abbreviated Injury Scale (AIS) ranks injuries on a scale of 1 to 6, with 1 being minor, 2 moderate, 3 serious, 4 severe, 5 critical and 6 an unsurvivable injury. A priori secondary analyses included the subgroup of participants in each intervention group with a head AIS≥4, which is a diagnostic indicator of severe to lethal head injury. Of this subset of participants with AIS≥4, a second subset of participants with a GOSE≤4 at the 6 month follow up was analyzed. GOSE≤4 represents Upper Severe Disability or worse outcomes. 15% of subjects required imputation analysis for 6-month GOSE.|6 months after injury|To adjust for 15% of subjects with absent 6-month GOSE data, an analysis using 20 hot deck imputations for the 6-month GOSE was done using data from patients who were discharged alive based on 1-month post discharge GOSE data or discharge GOSE (if 1-month post discharge data were not available), length of hospital stay, and treatment group.||Participants (with imputed values)|||Number
722413|NCT00316017|Secondary|Adult Respiratory Distress Syndrome(ARDS)-Free Survival Through Day 28|Absence of diagnosis of Adult Respiratory Distress Syndrome and alive through day 28|28 days from time of ED arrival|||participants|||Number
722392|NCT00316004|Primary|Glasgow Outcome Scale-Extended (GOSE)≤4 at 6 Months: Completer Analysis|Glasgow outcome score extended (GOSE) contains eight categories: 1. Dead, 2. Vegetative State (VS), 3. Lower Severe Disability (Lower SD), 4. Upper Severe Disability (Upper SD), 5. Lower Moderate Disability (Lower MD), 6. Upper Moderate Disability (Upper MD), 7. Lower Good Recovery (Lower GR) and 8. Upper Good Recovery (Upper GR). A measured neurological outcome of GOSE≤4 is a poor outcome of severe disability, vegetative state, or death. Completer analysis includes only those patients with GOSE completed at 6 months after injury.|6 months after injury|The primary analysis was designed as modified intent-to-treat, with all patients who had fluid connected to intravenous (IV) tubing included regardless of how much fluid was administered. Per the a priori trial design, patients for whom the fluid bag was opened but not connected to the IV were not considered enrolled in the trial.||Participants|||Number
722393|NCT00316017|Secondary|Greater Than 10 Units PRBC and Died Within 28 Days From the Time of the 911 Call|This is the total number of subjects who died within 28 days from the time of the 911 call among the patients who received greater than 10 units of packed red blood cells (PRBC).|From the time dispatch received the 911 call to 28 days|||participants|||Number
722394|NCT00316017|Secondary|Greater Than 10 Units PRBC and Died Within 6 Hours of Admission to the Hospital|This is the total number of subjects who died within the first 6 hours from the time of admission to the hospital among the patients who received greater than 10 units of packed red blood cells (PRBC).|The first 6 hours from the time of admission to the hospital|||participants|||Number
722395|NCT00316017|Secondary|Greater Than 10 Units PRBC and Died in Field or ED|This is the total number of subjects who died in the field or the ED among the patients who received greater than 10 units of packed red blood cells (PRBC).|From the time dispatch received 911 call to the time of death in the field or ED|||participants|||Number
722396|NCT00316017|Secondary|Greater Than 10 Units PRBC in First 24 Hours|This is the total number of subjects who received greater than 10 units of packed red blood cells (PRBC) in the first 24 hours from the time of the 911 call.|From the time dispatch received the 911 call to the end of the first 24 hours|||participants|||Number
722397|NCT00316017|Secondary|1-9 Units PRBC and Died Within 28 Days From the Time of the 911 Call|This is the total number of subjects who died within 28 days from the time of the 911 call among the patients who received 1 to 9 units of packed red blood cells (PRBC).|From the time dispatch received the 911 call to 28 days|||participants|||Number
722398|NCT00316017|Secondary|1-9 Units PRBC and Died Within 6 Hours of Admission to the Hospital|This is the total number of subjects who died within the first 6 hours from the time of admission to the hospital among the patients who received 1 to 9 units of packed red blood cells (PRBC).|The first 6 hours from the time of admission to the hospital|||participants|||Number
722399|NCT00316017|Secondary|1-9 Units PRBC and Died in Field or ED|This is the total number of subjects who received 1 to 9 units of packed red blood cells (PRBC) among the patients who died in the field or the ED.|From the time dispatch received 911 call to the time of death in the field or ED|||participants|||Number
722400|NCT00316017|Secondary|1-9 Units PRBC in First 24 Hours|This is the total number of subjects who received 1 to 9 units of packed red blood cells (PRBC) in the first 24 hours from the time of the 911 call.|From the time dispatch received the 911 call to the end of the first 24 hours|||participants|||Number
722401|NCT00316017|Secondary|Zero Units PRBC and Died Within 28 Days From the Time of the 911 Call|This is the total number of subjects who died within 28 days from the time of the 911 call among the patients who received no units of PRBC.|From the time dispatch received the 911 call to 28 days|||participants|||Number
722402|NCT00316017|Secondary|Zero Units PRBC and Died Within 6 Hours of Admission to the Hospital|This is the total number of subjects who died within the first 6 hours from the time of admission to the hospital among the patients who received no blood products.|The first 6 hours from the time of admission to the hospital|||participants|||Number
722403|NCT00316017|Secondary|Zero Units PRBC and Died in Field or Emergency Department (ED)|This is the total number of subjects who died in the field or the ED from the set of subjects who received no blood products.|From the time dispatch received 911 call to the time of death in the field or ED|||participants|||Number
722404|NCT00316017|Secondary|Zero Units PRBC in First 24 Hours|This is the total number of subjects who received no blood products in the first 24 hours from the time of the 911 call.|From the time dispatch received the 911 call to the end of the first 24 hours|||participants|||Number
722405|NCT00316017|Secondary|Survival at Hospital Discharge|Alive at the time of discharge from the Level One or Two trauma hospital. This did not include disposition from rehabilitation facilities.|Duration of hospital stay through to discharge|||participants|||Number
722406|NCT00316017|Secondary|Days Alive Out of the Hospital Through Day 28|The number of days the patient is alive and no longer an inpatient in the hospital through day 28|First 28 days from the time of 911 call|||days||Standard Deviation|Mean
722407|NCT00316017|Secondary|Days Alive Out of the Intensive Care Unit (ICU) Through Day 28|The number of days the patient is alive and not being cared for in the intensive care unit|First 28 days from the time of 911 call|||days||Standard Deviation|Mean
722408|NCT00316017|Secondary|Ventilator-free Days Through Day 28|"The number of days beginning with the day of 911 call counted as Day O through day 28 that the patient did not require mechanical ventilation"|Duration of hospital stay through day 28|||days||Standard Deviation|Mean
722409|NCT00316017|Secondary|Total Fluids First 24 Hours|The total amount of IV fluids given in the pre-hospital setting and the hospital setting in the first 24 hours following the time of 911 call|First 24 hours from the time of of 911 call|||Liters||Standard Deviation|Mean
722410|NCT00316017|Secondary|Packed Red Blood Cells (PRBC) First 24 Hours|The numbers of units of packed red blood cells transfused in the first 24 hours|First 24 hours from the time of 911 call|||units of packed red blood cells||Standard Deviation|Mean
722411|NCT00316017|Secondary|Presence of Nosocomial Infection Through Day 28|Includes one or more nosocomial infections from the following list: pneumonia, blood stream infection, urinary tract infection and wound infection|Within 28 days of injury, while hospitalized|||participants|||Number
722414|NCT00316017|Primary|28 Day Survival|"The day of episode is counted as Day 0. So for measures using a 28 day period, the maximum value is 29 (i.e. days 0 through 28)."|28 days from time of Emergency Department (ED) arrival|Per protocol, analysis was done on only those subjects who received the study fluid per randomization; this was defined as that the study fluid had been connected to the patient's IV.||participants|||Number
722415|NCT00316082|Secondary|Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24|Mean change from baseline for 0 to 180 minutes PPG AUC at Week 24, adjusted for baseline value.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.||mg*min/dL||Standard Error|Mean
722416|NCT00316082|Secondary|Percentage of Participants Achieving A1C < 7% at Week 24|Percentage of participants achieving A1C < 7%, the American Diabetes Association’s defined goal for glycemia, at each dose of saxagliptin versus placebo at Week 24.|Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in the Week 24 LOCF analysis, participants must have had at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.||Percentage of participants|||Number
722417|NCT00316082|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Mean change from baseline in FPG at Week 24, adjusted for baseline value.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.||mg/dL||Standard Error|Mean
722418|NCT00316082|Secondary|Change From Baseline in A1C at Week 24 - Saxagliptin 5 mg QPM|Mean change from baseline in A1C at Week 24, adjusted for baseline value.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.||percent||Standard Error|Mean
722419|NCT00316082|Primary|Change From Baseline in Hemoglobin A1 (A1C) at Week 24|Mean change from baseline in A1C at Week 24, adjusted for baseline value.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement. If participant received rescue medication, measurement must have been taken before rescue.||percent||Standard Error|Mean
722420|NCT00316121|Primary|Subject Success (Success is Defined Only if All of These Criteria Are Fulfilled)|Success is bridging bone, slip of study level versus adjacent levels less than 3 millimeters, angulation less than 5 degrees, 15 point increase in Oswestry Disability Index (ODI) (how back/leg trouble affects activities of daily living), no new problems in motor strength in legs, presence/absence of pain on leg raise, sensation intact on thigh/leg/foot reflexes of the knees/ankles, no permanent/serious complications, no revision/removal/reoperation/supplemental fixation. The ODI is on a 6 point scale from 0 (no pain/no impact on duties) to 5 (worst pain ever/unable to perform duties).|24 months|Safety Population:All subjects treated. Full Analysis Set(FAS):Subset of Safety Pop. w/follow up. All effectiveness measures were to be assessed on FAS. FAS is intent-to-treat pop. Per Protocol: Subset of FAS who complete study, treated as randomized w/no major protocol deviations. All analyses were to be on this subset.||Subjects|||Number
722421|NCT00316173|Secondary|Time to Disease Progression|"Although “Time to Disease Progression” was stated as an endpoint in the protocol, the definition given in the protocol (and used in the study) was that of “Progression-free Survival”. As such, “Progression-free Survival” was measured, not “Time to Disease Progression”. See the outcome measure entitled Progression-free Survival for data pertaining to time to disease progression."|From start of treatment to disease progression/death|Intent-to-Treat (ITT) Population: all participants who received at least one dose of study drug|||||
722422|NCT00316173|Secondary|The Number of Participants Classified as Responders in Cancer Antigen 125 (CA-125)|CA-125 is a “tumor marker”, found in greater concentration in tumor cells than other cells of the body. Participants were classed as responders if their CA-125 level at the end of study was 50% or less of baseline. In addition, a confirmatory sample (taken at least 28 days after the first sample) must have also been 50% or less of baseline.|Baseline to end of study (up to 54.7 weeks).|Intent-to-Treat (ITT) Population: all participants who received at least one dose of study drug||participants|||Number
722423|NCT00316173|Secondary|Number of Participants Who Died From the Start of Treatment to Follow-up|"The number of participants who died from the start of treatment to follow-up was calculated. For participants who did not die, the date of last contact was used. The word used for such participants was censored."|From start of treatment to death (up to 110.4 weeks).|Intent-to-Treat (ITT) Population: all participants who received at least one dose of study drug||participants|||Number
722424|NCT00316173|Secondary|Progression-free Survival|"Progression-free survival (PFS) was calculated as the time from the start of treatment until disease progression or death. For participants who did not have disease progression or did not die, the date on which alternative anti-cancer therapy began was used, or the date of last contact (if sooner). The word used for such participants was censored. Although “Time to Disease Progression” was stated as an endpoint in the protocol, the definition given in the protocol (and used in the study) was that of “PFS”. As such, “PFS” was measured, not “Time to Disease Progression”."|From start of treatment to disease progression/death (up to 67.7 weeks)|Intent-to-Treat (ITT) Population: all participants who received at least one dose of study drug||weeks||95% Confidence Interval|Median
722425|NCT00316173|Primary|Number of Participants With the Indicated Response|Overall response rate, as determined by radiologic evaluation (utilizing the World Health Organization [WHO] criteria and/or physical examination was measured. Complete response (CR: complete disappearance of all lesions), partial response (PR: >50% decrease in the measurements of the largest lesions with no appearance of new lesions), stable disease (SD: no change in tumor size for at least 8 weeks) and progressive disease (PD: >25% increase in measurements of lesions or appearance of new lesions).|From start of treatment to evidence of CR or PR (up to 39.3 weeks).|Intent-to-Treat (ITT) Population: all participants who received at least one dose of study drug||participants|||Number
722506|NCT00316719|Secondary|Rate of Emergence of Resistant Virus at Week 52|Participants with resistant mutation at Week 52. LAM resistant mutation (enzyme-linked mini-sequencing assay): rtM204I/V; ADV resistant mutation (direct sequencing assay): rtN236T or rtA181T/V in HBV DNA ; rt: reverse transcriptase gene|Week 52|PPS||Percentage of participants|||Number
722426|NCT00316173|Secondary|Duration of Response|"Duration of response was calculated as the time from first documented PR or CR until disease progression or death. For participants who did not have disease progression or did not die, the date on which alternative anti-cancer therapy began was used, or the date of last contact (if sooner). The word used for such participants was censored."|From time of PR or CR to disease progression/death (up to 56.0 weeks)|All participants who showed a tumor response (CR or PR).||weeks||95% Confidence Interval|Median
722427|NCT00316173|Secondary|Time to Response|Time to response was calculated as the time from start of treatment until first evidence of partial response (PR; >50% decrease in the measurements of the largest lesions with no appearance of new lesions) or complete response (CR; complete disappearance of all lesions).|From start of treatment to evidence of PR or CR (up to 39.3 weeks)|All participants who showed a tumor response (CR or PR).||weeks||95% Confidence Interval|Median
722428|NCT00316186|Secondary|Grade 4 (Life-threatening or Disabling) Hematological Toxicities|Hematology evaluation included hemoglobin, hematocrit, red blood cell count, white blood cell with differential and platelet count. Differential included neutrophils, bands, lymphocytes, monocytes, eosinophils, and basophils. The intensity of each hematological toxicity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAEs). Hematological toxicities are summarized by Common Terminology Criteria (CTC) V3.0 Maximum Toxicity Grade.|Week 1 through Endpoint (variable based on disease progression or toxicity|ITT population (i.e., participants who had at least one dose of study medication)||participants|||Number
722429|NCT00316186|Secondary|Grade 3 (Severe) Hematological Toxicities|Hematology evaluation included hemoglobin, hematocrit, red blood cell count, white blood cell with differential and platelet count. Differential included neutrophils, bands, lymphocytes, monocytes, eosinophils, and basophils. The intensity of each hematological toxicity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAEs). Hematological toxicities are summarized by Common Terminology Criteria (CTC) V3.0 Maximum Toxicity Grade.|Week 1 through Endpoint (variable based on disease progression or toxicity|ITT population (i.e., participants who had at least one dose of study medication)||participants|||Number
722430|NCT00316186|Secondary|Grade 2 (Moderate) Hematological Toxicities|Hematology evaluation included hemoglobin, hematocrit, red blood cell count, white blood cell with differential and platelet count. Differential included neutrophils, bands, lymphocytes, monocytes, eosinophils, and basophils. The intensity of each hematological toxicity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAEs). Hematological toxicities are summarized by Common Terminology Criteria (CTC) V3.0 Maximum Toxicity Grade.|Week 1 through Endpoint (variable based on disease progression or toxicity|ITT Population (i.e., participants who had at least one dose of study medication)||participants|||Number
722431|NCT00316186|Secondary|Grade 1 (Mild) Hematological Toxicities|Hematology evaluation included hemoglobin, hematocrit, red blood cell count, white blood cell with differential and platelet count. Differential included neutrophils, bands, lymphocytes, monocytes, eosinophils, and basophils. The intensity of each hematological toxicity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAEs). Hematological toxicities are summarized by Common Terminology Criteria (CTC) V3.0 Maximum Toxicity Grade.|Week 1 through Endpoint (variable based on disease progression or toxicity)|ITT Population (i.e., participants who had at least one dose of study medication)||participants|||Number
722432|NCT00316186|Secondary|Overall Survival, Calculated as the Number of Subjects Who Died From the Start of Treatment Until Follow-up|Overall survival is defined as the time from the start of treatment until death due to any cause. The study was terminated after the dose-finding run-in component was completed because of slow recruitment and acknowledgement of a competing Phase II study. Data not available, as the activity stage of the study was not conducted.|Week 1 up to maximum of Day 519||||||
722433|NCT00316186|Secondary|Time to Progression|Time to progression is defined as the time from the start of treatment until the first documented sign of disease progression or death due to any cause, if sooner. The study was terminated after the dose-finding run-in component was completed because of slow recruitment and acknowledgement of a competing Phase II study. Data not available.|From start of treatment to disease progression/death||||||
722434|NCT00316186|Secondary|Response Duration|Duration of response is calculated as the time from first documented partial or complete response until first documented sign of disease progression or death. The study was terminated after the dose-finding run-in component was completed because of slow recruitment and acknowledgement of a competing Phase II study. Data not available.|From time of partial or complete response to disease progression/death||||||
722435|NCT00316186|Secondary|Time to Response|Time to response is calculated as the time from the start of treatment until first documented evidence of partial or complete response. The study was terminated after the dose-finding run-in component was completed because of slow recruitment and acknowledgement of a competing Phase II study. Data not available, as the activity stage was not done.|From start of treatment to evidence of partial or complete response||||||
722436|NCT00316186|Primary|Overall Response Rate, as Determined by Radiologic Evaluation (Utilizing the World Health Organization [WHO] Criteria), Calculated as the Number of Participants With the Indicated Response|The categories of tumor response were: complete response (complete disappearance of all known lesions determined by 2 measurements not less than 4 weeks apart), partial response (>50% decrease in measurable lesions for at least 4 weeks with no appearance of new lesions), stable disease (no change in tumor size for at least 8 weeks), progressive disease (>25% increase in measurements of lesions or appearance of new lesions), and not evaluable. The overall response rate was determined using a scan performed within the first 30 days of the first response.|Baseline until up to Day 169|ITT (Intent to Treat): participants that received at least one dose of study drug||Participants|||Number
722437|NCT00316199|Secondary|Overall Survival Probability|Original outcome was overall survival = time from date of enrollment to date of death due to any cause. Survival time was censored at date of last contact for participants who were still alive or lost to follow-up. Because only 8 participants had documented death while on study, results are reported as 6- and 12-month overall survival probability.|baseline to date of death from any cause|All enrolled participants. Fifty-two participants were censored.||percent|||Number
722507|NCT00316719|Secondary|Time to Onset of ALT Normalization|Time to onset of ALT normalization was summarized using the Kaplan-Meier method.|From Baseline to Week 52|PPS: Participants with abnormal ALT value (>ULN) at baseline||Week 52||95% Confidence Interval|Median
722438|NCT00316199|Secondary|Duration of Response|Measured from the time of first documentation of complete response (CR) or partial response (PR), whichever status is first recorded, until the date of objective disease progression or death on study, whichever occurs first, with censoring defined in the same way as for progression-free survival.|time of response to measured progressive disease or death (tumor assessments were performed every 2 cycles during study therapy, or 3 months during post-therapy until disease progression, or up to 12 months after enrollment)|Enrolled participants who were considered responders (had either a complete response or partial response).||months||95% Confidence Interval|Median
722439|NCT00316199|Secondary|Progression-Free Survival|Defined as the time from enrollment to the date of objective disease progression or death on study, whichever occurs first. Censoring was determined based on US-FDA 2005 draft guidance on clinical endpoints.|baseline to measured progressive disease or death (tumor assessments were performed every 2 cycles during study therapy, or 3 months during post-therapy until disease progression, or up to 12 months after enrollment)|All enrolled participants. Forty-two participants were censored.||months||95% Confidence Interval|Median
722440|NCT00316199|Secondary|Time to Treatment Failure|Defined as time from enrollment to the date of death due to any cause, measured disease progression, treatment discontinuation for undocumented progression, early treatment discontinuation for toxicity or other reason, or new anticancer treatment started.|baseline to stopping treatment|All enrolled participants. Time to treatment failure for participants who are still participating in the study without treatment failure at the time of analysis will be treated as censored at thte date of the last tumor assessment (3 participants censored).||months||95% Confidence Interval|Median
722441|NCT00316199|Primary|Best Overall Tumor Response|"Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve (respond), stay the same (stable), or worsen (progression) during treatment."|baseline to measured progressive disease (tumor assessments were performed every 2 cycles during study therapy, or 3 months during post-therapy until disease progression, or up to 12 months after enrollment)|All enrolled participants diagnosed with metastatic breast cancer, had measurable disease at baseline, and received at least one dose of study drug. Two participants were excluded from analysis because they received chemotherapy for locally advanced/metastatic breast cancer within 6 months prior to enrollment.||participants|||Number
722442|NCT00316225|Primary|Overview of Adverse Events|Any untoward medical occurrence in a patient who received study drug was considered an adverse event (AE), without regard to possibility of causal relationship. Treatment-emergent adverse events (TEAE): those which occurred or worsened after baseline. An adverse event resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a serious adverse event (SAE): death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|baseline, up to 18 weeks|Patients who received at least one dose of study drug.||participants|||Number
722443|NCT00316225|Secondary|Discontinuations Due to Adverse Events|Adverse events were coded using the Medical Dictionary for Regulatory Activities, Version 11.0.|baseline, up to 18 weeks|Patients who received at least one dose of study drug.||participants|||Number
722444|NCT00316225|Other Pre-specified|Overall Tumor Response|"Overall tumor response was determined using Response Evaluation Criteria In Solid Tumors (RECIST), which defines when cancer patients improve (respond), stay the same (stabilize), or worsen (progression) during treatments.
CR (complete response) = disappearance of all target lesions. PR (partial response) = 30% decrease in the sum of the longest diameter of target lesions.
PD (progressive disease) = 20% increase in the sum of the longest diameter of target lesions.
SD (stable disease) = small changes that do not meet above criteria."|baseline, up to 18 weeks|Patients who received at least one dose of study drug.||participants|||Number
722445|NCT00316225|Secondary|Pemetrexed Population Pharmacokinetics: Volume of Distribution|Volume of distribution is the theoretical size of the compartment necessary to account for total drug amount in the body if it were present throughout the body in the same concentration found in plasma. Volume of distribution is defined as distribution of pemetrexed in the body and is determined by volume of distribution = dose/drug concentration. By knowing dose and measuring concentration of pemetrexed in plasma, volume was calculated. Central volume (V1) was determined by dose/peak serum level of pemetrexed. Peripheral volume (V2) is sum of all tissue spaces outside the central compartment.|Cycle 1 and Cycle 2: before the end of infusion (approximately 9.5 minutes), 2 hours, 9-10 hours, 24-48 hours, 480-528 hours (20 to 22 days) after start of pemetrexed infusion|Patients who received at least one dose of study drug.||Liters (L)||Standard Deviation|Mean
722446|NCT00316225|Secondary|Pemetrexed Population Pharmacokinetics (PK): Clearance|Clearance (CL) can be defined as the volume of plasma which is completely cleared of drug (pemetrexed) per unit time. Total body clearance is calculated after intravenous administration of the drug (pemetrexed) and is measured by taking plasma samples at various timepoints and measuring the amount of pemetrexed in the plasma.|Cycle 1 and Cycle 2: before the end of infusion (approximately 9.5 minutes), 2 hours, 9-10 hours, 24-48 hours, 480-528 hours (20 to 22 days) after start of pemetrexed infusion|Patients who received at least one dose of study drug.||milliliter per minute (mL/min)||Standard Deviation|Mean
722447|NCT00316225|Secondary|Number of Participants With Common Toxicity Criteria - National Cancer Institute Grade 3 and Grade 4 Toxicities|"Number of participants with laboratory and non-laboratory toxicities possibly related to study drug, which were graded using the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) for defining and grading specific adverse events. Grades range from 0 (none) to 5 (death). Grade 3 is severe and Grade 4 is life-threatening.
NOS = Not otherwise specified."|baseline, up to 18 weeks|Patients who received at least one dose of study drug.||participants|||Number
722448|NCT00316264|Secondary|The Immunogenicity of Palivizumab at Any Time|Number of subjects with detected anti-palivizumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.|At any time|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.||participants with detected antibody|||Number
722544|NCT00324415|Secondary|Toxicity|Delayed toxicities are defined as toxicities that occur over 90 days following treatment completion|90 days following treatment discontinuation|||events|||Number
722449|NCT00316264|Secondary|The Immunogenicity of Palivizumab at 120 to 150 Days Post Final Dose|Number of subjects with detected anti-palivizumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.|120 - 150 days post final pose|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.||participants with detected antibody|||Number
722450|NCT00316264|Secondary|The Immunogenicity of Palivizumab at Day 150|Number of subjects with detected anti-palivizumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.|Day 150|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.||participants with detected antibody|||Number
722451|NCT00316264|Secondary|The Immunogenicity of Palivizumab at Day 60|Number of subjects with detected anti-palivizumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.|Day 60|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.||participants with detected antibody|||Number
722452|NCT00316264|Secondary|The Immunogenicity of Palivizumab at Day 0|Number of subjects with detected anti-palivizumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.|Day 0|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.||participants with detected antibody|||Number
722453|NCT00316264|Secondary|The Immunogenicity of Motavizumab at Any Time|Number of subjects with detected anti-motavivumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.|At any time|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.||participants with detected antibody|||Number
722454|NCT00316264|Secondary|The Immunogenicity of Motavizumab at 120 to 150 Days Post Final Dose|Number of subjects with detected anti-motavivumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.|120 - 150 days post final dose|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.||participants with detected antibody|||Number
722455|NCT00316264|Secondary|The Immunogenicity of Motavizumab at Day 150|Number of subjects with detected anti-motavivumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.|Day 150|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.||participants with detected antibody|||Number
722456|NCT00316264|Secondary|The Immunogenicity of Motavizumab at Day 60|Number of subjects with detected anti-motavivumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.|Day 60|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.||participants with detected antibody|||Number
722457|NCT00316264|Secondary|The Immunogenicity of Motavizumab at Day 0|Number of subjects with detected anti-motavivumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.|Day 0|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.||participants with detected antibody|||Number
722458|NCT00316264|Secondary|The Trough Serum Concentrations of Palivizumab at 120-150 Days Post Final Dose||120-150 days post final dose|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.||μg/mL||Standard Deviation|Mean
722459|NCT00316264|Secondary|The Trough Serum Concentrations of Palivizumab at Day 150||Day 150|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.||μg/mL||Standard Deviation|Mean
722460|NCT00316264|Secondary|The Trough Serum Concentrations of Palivizumab at Day 60||Day 60|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.||μg/mL||Standard Deviation|Mean
722461|NCT00316264|Secondary|The Serum Concentrations of Palivizumab at Day 0||Day 0|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.||μg/mL||Standard Deviation|Mean
722655|NCT00326716|Primary|Infant Race||At the time of delivery|All infants.||Participants|||Number
722462|NCT00316264|Secondary|The Trough Serum Concentrations of Motavizumab 120-150 Days Post Final Dose||120-150 days post final dose|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.||μg/mL||Standard Deviation|Mean
722463|NCT00316264|Secondary|The Trough Serum Concentrations of Motavizumab at Day 150||Day 150|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.||μg/mL||Standard Deviation|Mean
722464|NCT00316264|Secondary|The Trough Serum Concentrations of Motavizumab at Day 60||Day 60|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.||μg/mL||Standard Deviation|Mean
722465|NCT00316264|Secondary|The Serum Concentrations of Motavizumab at Day 0||Day 0|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.||μg/mL||Standard Deviation|Mean
722466|NCT00316264|Primary|Number of Subjects With Changes in Laboratory Chemistry Values Reported as AEs.|Serum chemistry samples were collected at Day 0, Day 60, and Day 150. Values representing changes in severity according to the AE grading table were recorded as AEs.|Day 0 - Day 150|The safety population included all randomized subjects who received study drug and had any safety follow-up.||participants|||Number
722467|NCT00316264|Primary|Number of Subjects Reporting Adverse Events (AEs)||Day 0 - Day 150|The safety population included all randomized subjects who received study drug and had any safety follow-up.||participants|||Number
722468|NCT00316264|Primary|Number of Subjects Reporting Serious Adverse Events (SAEs)||Day 0 - Day 150|The safety population included all randomized subjects who received study drug and had any safety follow-up.||participants|||Number
722469|NCT00316277|Primary|The Number of Participants Attaining Successful Opioid Use Outcome by Counseling Condition, Phase 2 End of Treatment|In phase 2, successful outcome was defined as abstaining from opioids during week 12 (the final week of buprenorphine-naloxone stabilization) and during at least 2 of the previous 3 weeks (weeks 9-11). This outcome measure required substantial improvement but not complete abstinence.|12 weeks in Phase 2 period (i.e., 24 weeks into the study)|360 participants randomized to Phase 2 were included in the analysis.||participants|||Number
722470|NCT00316277|Secondary|The Number of Participants With and Without Any Lifetime Use of Heroin Attaining Successful Opioid Use Outcomes in Phase 2|As a planned secondary analysis, we examined the impact of the two phase 1 stratification variables on the primary outcome.|12 weeks|||participants|||Number
722471|NCT00316277|Secondary|The Number of Participants With and Without Any Lifetime Use of Heroin Attaining Successful Opioid Use Outcomes in Phase 1|As a planned secondary analysis, we examined the impact of the two phase 1 stratification variables on the primary outcome.|12 weeks|Participants randomized to Phase 1 were stratified by two variables: current chronic pain and lifetime heroin use.||participants|||Number
722472|NCT00316277|Secondary|The Number of Participants Attaining Successful Opioid Use Outcomes in Phase 2 by Chronic Pain Condition|"As a planned secondary analysis, we examined the impact of the two Phase 1 stratification variables on the primary end points. Patients were designated at baseline as having current chronic pain if they reported pain other than everyday kinds of pain excluding withdrawal-related pain, for at least 3 months."|12 weeks|||participants|||Number
722473|NCT00316277|Secondary|The Number of Participants Attaining Successful Opioid Use Outcomes in Phase 1 by Chronic Pain Condition|"As a planned secondary analysis, we examined the impact of the two Phase 1 stratification variables on the primary end points. Patients were designated at baseline as having current chronic pain if they reported pain other than everyday kinds of pain excluding withdrawal-related pain, for at least 3 months."|12 weeks|379 identified as having chronic pain at baseline in Phase 1.||participants|||Number
722474|NCT00316277|Secondary|The Number of Participants Attaining Successful Opioid Use Outcome by Counseling Condition Phase 2, 8-week Posttreatment Follow-up|A planned secondary outcome, successful outcome at week 24, that is, 8 weeks after completion of buprenorphine-naloxone taper, was defined the same as at week 12 of Phase 2, that is abstinent from opioids during week 24 and at least 2 of the previous 3 weeks.|24 weeks in Phase 2 period (i.e., 36 weeks into the study)|360 participants randomized to Phase 2 were included in the analysis.||participants|||Number
722475|NCT00316277|Primary|The Number of Participants Attaining Successful Opioid Use Outcome by Counseling Condition at End of Phase 1|In Phase 1, successful outcome was defined as completing week 12 with self-reported opioid use on no more than 4 days in a month, absence of 2 consecutive opioid-positive urine test results, no additional substance use disorder treatment (other than self-help), and no more than 1 missing urine sample during the 12 weeks.|12 weeks|653 study participants randomized to Phase 1 were included in analysis.||participants|||Number
722476|NCT00316303|Primary|Referral for Medical Care|For participants infected with hepatitis C, their self-report of being referred for medical care.|6 Months|||participants|||Number
722477|NCT00316303|Primary|Tested for HIV|Participant self-report of being tested for HIV|6 Months|||participants|||Number
722478|NCT00316303|Primary|Tested for Hepatitis B|Participant self-report of being tested for hepatitis B|6 Months|||participants|||Number
722479|NCT00316303|Primary|Tested for Hepatitis C|Participant self-report of being tested for hepatitis C|6 Months|||participants|||Number
722480|NCT00316303|Primary|Change in Immunization Status|Of the participants that were not immunized at baseline, the number of participants who were immunized for Hepatitis A and B at 6 months.|Measured at 6 Months relative to Baseline|||participants|||Number
722481|NCT00316355|Primary|Treatment-related Total Cost Estimates|total estimated costs calculated based upon the fixed-dose schedule|Posttreatment|Treatment completers||dollars||Standard Deviation|Mean
722656|NCT00326716|Primary|Infant Gender||At the time of delivery|All infants.||Participants|||Number
722482|NCT00316355|Primary|Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) Total Score|The Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) total score was used as the outcome measure. The Y-BOCS is a clinician-rated scale assessing obsession (5 items) and compulsion (5 items) symptom severity on a 0 to 4 scale. All 10 items are added for the total score, with total scores ranging from 0 to 40, and higher numbers indicating more severe symptoms.|Pretreatment, Posttreatment, and 3-month follow-up|Randomized participants||units on a scale||Standard Deviation|Mean
722483|NCT00316693|Secondary|Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples|"Abnormalities in concentrations (expressed as milligrams per deciliter [mg/dL]) are presented categorical as follows:
Protein: <10 (-)*; 10-25 (+-)*; 25-85 (+); 85-250 (2+); 250-800 (3+).
Glucose: <30 (-)*; 30-60 (+-)*; 60-125 (+); 125-250 (2+); 250-750 (3+).
Urobilinogen: <1.5 (+-)*; 1.5-3.5 (+); 3.5-7 (2+); 7-14 (3+).
Bilirubin: <0.35 (-)*; 0.35-1.5 (+); 1.5-5 (2+); 5-12 (3+).
Occult blood: <0.015 (-)*; 0.015-0.045 (+-); 0.045-015 (+); 0.15-0.75 (2+); >0.75 (3+).
Ketone body: <2.5 (-)*; 2.5-7.5 (+-); 7.5-30 (+); 30-70 (2+); 70-125 (3+).
Normal ranges indicated by asterix*."|At Month 0 and Month 7|Analysis was performed on the Total Vaccinated cohort.||Subjects|||Number
722484|NCT00316693|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters|"Biochemical parameters were assessed in blood samples. Abnormalities reported include values outside the normal ranges: values higher than normal are designated as Above and values lower than normal as Below while Unknown stands for values not determined.
Abbreviations: aminotransferase (ALT), aspartate aminotransferase (ASP), C reactive protein (CRP), gamma-glutamyl-transferase (GGT) and lactate dehydrogenase (LDH)."|At Month 0 and Month 7|Analysis was performed on the Total Vaccinated Cohort.||Subjects|||Number
722485|NCT00316693|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters|"Hematological parameters assessed in blood samples include hemoglobin, haematocrit, mean corpuscular (MC) hemoglobin, mean corpuscular (MC) hemoglobin concentration, mean corpuscular (MC) volume, platelet count, red blood cell count, white blood cell count.
Abnormalities reported include values outside the normal ranges: values higher than normal are designated as Above and values lower than normal as Below while Unknown stands for values not determined."|At Month 0 and Month 7|Analysis was performed on the Total Vaccinated Cohort.||Subjects|||Number
722486|NCT00316693|Secondary|Outcome of Any Reported Pregnancies|Information on any subject who became pregnant while participating in this study was collected. The outcomes of the pregnancies are reported below.|Throughout the study period (up to Month 24)|Analysis was performed on those subjects reporting pregnancy during the study period.||Subjects|||Number
722487|NCT00316693|Secondary|Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs)|NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. MSC include adverse events (AEs) prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|Throughout the study period (up to Month 24)|Analysis was performed on the Total Vaccinated Cohort.||Subjects|||Number
722488|NCT00316693|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Throughout the study period (up to Month 24)|Analysis was performed on the Total Vaccinated Cohort.||Subjects|||Number
722489|NCT00316693|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within 30 days after any vaccination|Analysis was performed on the Total Vaccinated Cohort.||Subjects|||Number
722490|NCT00316693|Secondary|Number of Subjects Reporting Solicited Local and General Symptoms|Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include arthralgia, fatigue, fever (above 37.5 degree Celsius), gastrointestinal symptoms, headache, myalgia, rash and urticaria.|Within 7 days after each and any vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.||Subjects|||Number
722491|NCT00316693|Secondary|Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies|Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).|At Months 0, 6, 7, 12, 18 and 24|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity.||EL.U/mL||95% Confidence Interval|Geometric Mean
722492|NCT00316693|Secondary|Number of Subjects With Anti-human Papillomavirus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibody Titers Above the Cut-off Value|Anti-HPV-16 antibody cut-off value assessed include 8 ELISA units per milliliter (EL.U/mL) and anti-HPV-18 antibody cut-off value assessed include 7 EL.U/mL.|At Months 0 (pre-vaccination), 6, 7, 12, 18 and 24|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity.||Subjects|||Number
722493|NCT00316693|Secondary|Number of Subjects With Histopathologically Confirmed Lesions Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type|"Histopathologically-confirmed lesions assessed include cervical intraepithelial neoplasia of grade 1 (CIN1), grade 2 (CIN2), grade 3 (CIN3) and adenocarcinoma. These lesions were assessed in women who were, for the corresponding HPV type (determined by polymerase chain reaction)), HPV deoxyribonucleic acid (DNA) negative at Month 0 and Month 6.
Oncogenic (high risk [HR]) HPV types assessed include HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68."|Up to Month 24|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data.||Subjects|||Number
722494|NCT00316693|Secondary|Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type|"Cytologically-confirmed abnormalities assessed include ASC-US, LSIL, HSIL, ASC-H and AGC. These cytological abnormalities were assessed in women who were, for the corresponding HPV type (determined by PCR), HPV DNA negative (by PCR) at Month 0 and Month 6.
Oncogenic (high risk [HR]) HPV types assessed include HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68."|Up to Month 24|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data.||Subjects|||Number
722495|NCT00316693|Secondary|Number of Subjects With Persistent Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types|"Persistent infection for oncogenic HPV types is defined as at least 2 positive HPV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assays for the same viral genotype with no negative DNA sample between the 2 positive DNA samples, over an approximate interval of 6 months (> 150 days) [as assessed in women who were, for the corresponding HPV type, HPV DNA negative (by PCR) at Month 0 and Month 6].
Oncogenic (high risk [HR]) HPV types assessed include HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68."|Up to Month 24|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data.||Subjects|||Number
722496|NCT00316693|Secondary|Number of Subjects With Incident Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types|"Incident infection for oncogenic HPV types is defined as at least one positive oncogenic HPV type deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assay in women who were, for the corresponding HPV type, HPV DNA negative (by PCR) at Month 0 and Month 6.
Oncogenic (high risk [HR]) HPV types assessed include HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68."|Up to Month 24|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data.||Subjects|||Number
722497|NCT00316693|Secondary|Number of Subjects With Histopathologically-confirmed Lesions Concurrently Associated With Human Papillomavirus 16 (HPV-16) and/or Human Papillomavirus (HPV-18) Cervical Infection|Histopathologically-confirmed lesions assessed include cervical intraepithelial neoplasia of grade 1 (CIN1), grade 2 (CIN2), grade 3 (CIN3) and adenocarcinoma. These lesions were assessed in women who were, for the corresponding Human Papillomavirus (HPV) type, seronegative at Month 0 and HPV deoxyribonucleic acid (DNA) negative (by polymerase chain reaction) at Month 0 and Month 6.|Up to Month 24|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data.||Subjects|||Number
722498|NCT00316693|Secondary|Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Human Papillomavirus 16 (HPV-16) and/or Human Papillomavirus 18 (HPV-18) Cervical Infection|Cytologically-confirmed abnormalities assessed include atypical squamous cells of undetermined significance (ASC-US), low-grade squamous intraepithelial lesion (LSIL), high-grade squamous intraepithelial lesion (HSIL), atypical squamous cells-can not exclude HSIL (ASC-H) and atypical glandular cells (AGC). These cytological abnormalities were assessed in women who were, for the corresponding Human Papillomavirus (HPV) type, seronegative at Month 0 and HPV deoxyribonucleic acid (DNA) negative (by polymerase chain reaction) at Month 0 and Month 6.|Up to Month 24|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data.||Subjects|||Number
722499|NCT00316693|Secondary|Number of Subjects With Incident Cervical Infection With Human Papillomavirus 16 (HPV-16) or Human Papillomavirus 18 (HPV-18)|HPV-16 or HPV-18 incident infection is defined as at least one positive HPV-16 or HPV-18 deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assay in women who were, for the corresponding HPV type, seronegative at Month 0 and HPV DNA negative (by PCR) at Month 0 and Month 6.|Up to Month 24|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data.||Subjects|||Number
722500|NCT00316693|Primary|Number of Subjects With Persistent Cervical Infection With Human Papillomavirus 16 (HPV-16) or Human Papillomavirus 18 (HPV-18)|Persistent HPV-16 or HPV-18 infection is defined as at least 2 positive Human Papillomavirus (HPV) deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assays for the same viral genotype with no negative DNA sample between the 2 positive DNA samples, over an approximate interval of 6 months (> 150 days) [as assessed in women who were, for the corresponding HPV type, seronegative at Month 0 and HPV DNA negative (by PCR) at Month 0 and Month 6].|Throughout the study period (up to Month 24)|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data.||Subjects|||Number
722501|NCT00316706|Secondary|Number of Subjects Reporting Pregnancies, Serious Adverse Events (SAEs), New Onset Chronic Diseases (NOCDs), and Conditions Prompting Emergency Room During the Last 2 Years Follow-up|"Serious adverse events assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
New onset of chronic diseases (NOCDs) assessed include e.g. autoimmune disorders, asthma, type I diabetes."|From Month 24 to Month 48|Analyses were performed on the Total Vaccinated Cohort, on subjects with available data at the defined time point. Analysis was only done for subjects in the Cervarix Group, as all subjects from the Havrix Group completed the study at Month 24.||Subjects|||Number
722502|NCT00316706|Secondary|Number of Subjects Reporting Pregnancies, Serious Adverse Events (SAEs), New Onset Chronic Diseases (NOCDs), and Conditions Prompting Emergency Room (ER) Visits or Physician Visits That Are Not Related to Common Diseases During the First 2 Years Follow-up|"SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
New onset of chronic diseases (NOCDs) assessed include e.g. autoimmune disorders, asthma, type I diabetes."|From Month 18 to Month 24|Analyses were performed on the Total Vaccinated Cohort, on subjects with available data at the defined time point.||Subjects|||Number
722503|NCT00316706|Secondary|Titers of Anti-3-O-desacyl 4'-Monophosphoryl Lipid A (Anti-MPL) Antibodies During the Last 2 Years Follow-up|Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL.|At Month 36 and 48|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data for the defined time point. Analysis was only done for subjects in the Cervarix Group, as all subjects from the Havrix Group completed the study at Month 24.||EL.U/mL||95% Confidence Interval|Geometric Mean
722504|NCT00316706|Secondary|Titers of Anti-3-O-desacyl-4'-Monophosphoryl Lipid A (Anti-MPL) Antibodies During the Initial 2 Years Follow-up|Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL.|At Months 18 and 24|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data for the defined time point.||EL.U/mL||95% Confidence Interval|Geometric Mean
722505|NCT00316706|Primary|Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies|Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).|At 18, 24, 36 and 48 months|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on those subjects from the Cervarix Group with available data for the defined time point.||EL.U/mL||95% Confidence Interval|Geometric Mean
722508|NCT00316719|Secondary|Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 52|ALT normalization was defined as an ALT value that was in the normal range (<= 45IU/L; upper limit of normal [ULN]) at Week 52 of the participants whose ALT values were abnormal (>45IU/L) at baseline|Week 52|PPS: Participants with an abnormal ALT value (>ULN) at baseline||Percentage of participants|||Number
722509|NCT00316719|Secondary|Mean Alanine Aminotransferase (ALT) Level at Week 52|Summary statistics were displayed for serum ALT.|Week 52|PPS||Units per Liter||Standard Deviation|Mean
722510|NCT00316719|Secondary|Percentage of Participants With Hepatitis B s Antigen/ Antibody (HBsAg/Ab) Seroconversion at Week 52|Participants with loss of Hepatitis B s antigen (HBsAg) and positive for anti-Hepatitis B s antibody (HBsAb) in serum collected by blood draw: CLIA method|Week 52|PPS: participants who were positive for HBsAg and negative for HBsAb at baseline||percentage of participants|||Number
722511|NCT00316719|Secondary|Percentage of Participants With Hepatitis B s Antigen (HBsAg) Loss at Week 52|Participants with loss of Hepatitis B s antigen (HBsAg) in serum collected by blood draw: CLIA method|Week 52|PPS: participants who were positive for HBsAg at baseline||percentage of participants|||Number
722512|NCT00316719|Secondary|Time to Onset of HBeAg/Ab Seroconversion|Time to onset of HBeAg/Ab seroconversion in serum collected by blood draw was summarized using the Kaplan-Meier method.: CLIA method. Regarding the Measured Values, the median time to onset and its lower limit and its upper limit for all groups are non-estimable because they are not observed until the end of the study.|From Baseline to Week 52||||||
722513|NCT00316719|Secondary|Time to Onset of HBeAg Loss|Time to onset with loss of HBeAg in serum collected by blood draw was summarized using the Kaplan-Meier method.: CLIA method. Regarding the Measured Values, the median time to onset and its lower limit and its upper limit for all groups are non-estimable because they are not observed until the end of the study.|From Baseline to Week 52||||||
722514|NCT00316719|Secondary|Percentage of Participants With Hepatitis B e Antigen/Antibody (HBeAg/Ab) Seroconversion at Week 52|Participants with loss of Hepatitis B e antigen (HBeAg) and positive for anti-Hepatitis B e antibody (HBeAb) in serum collected by blood draw: CLIA method|Week 52|PPS: participants who were positive for HBeAg and negative for HBeAb at baseline||Percentage of participants|||Number
722515|NCT00316719|Secondary|Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss at Week 52|Participants with loss of Hepatitis B e antigen (HBeAg) in serum collected by blood draw: Cheminoluminescent Immuno Assay (CLIA) method|Week 52|PPS: participants who were positive for HBeAg at baseline||percentage of participants|||Number
722516|NCT00316719|Secondary|Time to Onset of HBV DNA Loss (< 400 Copies/mL)|Time to onset of an HBV DNA level in serum of less than 400 copies/mL was summarized using the Kaplan-Meier method. Regarding the Measured Values, the median time to onset and its upper limit for the ADV group and the upper limit of the median time to onset for the LAM group are non-estimable because they are not observed until the end of the study. The lower limit of the median time to onset for the ADV and LAM groups are 36.0 and 20.0, respectively. The median time to onset for the LAM group is 28.0|From Baseline to Week 52||||||
722517|NCT00316719|Secondary|Percentage of Participants With HBV DNA Loss (<400 Copies/mL) at Week 52|The percentages of participants with an HBV DNA level in serum of less than 400 copies/mL, which is the lower limit of detection (HBV DNA loss) at Week 52|Week 52|PPS||Percentage of participants|||Number
722518|NCT00316719|Primary|Mean Change From Baseline in Hepatitis B Virus (HBV) DNA at Week 52|Change from baseline was the difference of the HBV DNA copy numbers (log10) in serum collected by blood draw between baseline and Week 52|Baseline and Week 52|Per Protocol Set (PPS): participants in the Full Analysis Set (all subjects who entered the study, received at least one dose of investigational product, and had at least one efficacy assessment after the treatment initiation) population with no major protocol violations||log10 copies/mL||Standard Deviation|Mean
722519|NCT00324233|Secondary|Subjectively Measured Insertion of the Catheter||||||||
722520|NCT00324233|Secondary|Subjectively Measured Handling||||||||
722521|NCT00324233|Primary|Residual Urine Measured by Ultra Sound||2|||ml||Standard Deviation|Mean
722522|NCT00324259|Post-Hoc|Metabolic Flare on FDG-PET/CT as Compared to Response||Baseline and 24 hours after administration of the first dose of estradiol|"The data was combined as the outcome was not based on comparison of the two groups but comparing the overall FDG-PET/CT metabolic flare to the overall responses.
10 participants were not evaluable because early toxicity prevented response assessment and the PET data was not considered technically adequate or not available in 8 participants."||participants|||Number
722523|NCT00324259|Secondary|Overall Survival (OS)||Until patient death|This outcome measure was not analyzed as the overall survival was not reported.|||||
722524|NCT00324259|Secondary|Frequency of Response to Re-treatment With Estradiol for Patients Who Have a Secondary Response to an Aromatase Inhibitor After the First Response to Estradiol.||Every 3 months|At the time that the study was powered there was not any information on any patients who were re-treated with estradiol after having a secondary response to a aromatase inhibitor after the first response to estradiol.|||||
722525|NCT00324259|Secondary|Frequency of Response to Re-treatment With the Same Aromatase Inhibitor That Immediately Preceded Treatment With Estradiol on Protocol.|Best overall response|12 weeks post-treatment termination|Only offered to patients experiencing clinical benefit on estradiol.||participants|||Number
722526|NCT00324259|Secondary|Quality of Life (FACT-B Mean Score)|"Surveyed using the multidimensional Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire
The FACT-B (version 4) questionnaire consists of 36 items with five-point scale, ranging from 0-4, where a total score ranges from 0-144 and higher scores indicate better QoL. The total FACT-B score is the sum of scores for five subscales including: physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and specific breast cancer concerns (9 items)."|Day 28|25 out of 34 participants in Arm 1 and 23 out of 32 participants completed the FACT-B questionnaire at Day 28 (4 weeks).||units on a scale||Standard Deviation|Mean
722527|NCT00324259|Secondary|Quality of Life|"Surveyed using a 6 item estrogen adverse effect questionnaire (headaches, bloating, breast tenderness, retention of fluid, nausea, and vomiting).
Used a 5-point scale ranging from 0 (not at all) to 4 (very much).
The scores from the 6 estrogen adverse effect items were summed to produce a single score, ranging from 0-24, with higher scores indicating higher adverse effects."|Baseline and Day 28|27 out of 34 participants in Arm 1 and 22 out of 32 participants in Arm 2 completed both the baseline and Day 28 (4 week) 6 item adverse effect questionnaire.||units on a scale||Standard Deviation|Mean
722528|NCT00324259|Secondary|Progression-free Survival (PFS)|"Defined as the time from treatment initiation to disease progression or death.
Time of last observation for patients remaining in the study and the time at which dose reductions, study drug termination, and withdrawal of consent occurred were treated as censored data.
Indicated as number of participants who had not progressed at 12 weeks, 24 weeks, 36 weeks, and 48 weeks.
Progression per RECIST 1.0 = at least a 20% increase in the sum of the longest diameter of target lesions taking as references the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions."|Up to 48 weeks|||participants|||Number
722529|NCT00324259|Primary|Clinical Benefit Rate (CR Plus PR Plus SD)|"Complete response (CR) + partial response (PR) + stable disease (SD) using RECIST 1.0
CR = disappearance of all target lesions
PR = at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter
SD = neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for progressive disease
SD is defined as lack of disease progression by 24 weeks."|24 weeks after start of treatment|||participants|||Number
722530|NCT00324272|Secondary|Death.|Death was recorded as the number of participants who had died by the end of the study follow-up period (1st June 2010). Deaths were recorded as either being related to the primary disease (i.e. due to distant metastasis) or death due to another (unrelated) cause (e.g. myocardial infarction or cerebrovascular accident).|From day of surgery until end of study follow-up period (1st June 2010)|||Participants.|||Number
722531|NCT00324272|Secondary|Disease Recurrence.|This was measured as either: 1. the number of participants with local recurrence; 2. the number of participants with in transit or regional recurrence; or 3. the number of participants with distant metastasis (but alive on 1st June 2010).|From date of surgery until end of study follow-up period (1st June 2010)|||Participants.|||Number
722532|NCT00324272|Secondary|Post Operative Pain Score Measured on 1st Post-operative Day.|Pain score was recorded at 24 hours following the completion of surgery using a Visual Analogue Score (using a scale of 1 [no pain] to 10 [very severe pain]) which the patient was asked to record.|During the immediate post-operative period.|||Units on a scale.||Inter-Quartile Range|Median
722533|NCT00324272|Secondary|Number of Patients With Post-operative Complications (Excluding Lymphoedema).|Complications were classified as being either 'Minor' (i.e. (managed without operation, prolonged hospital stay or readmission) or 'Major' (i.e. requiring surgical intervention or readmission to hospital). The number of patients with each 'Minor' and 'Major' complication were recorded.|Until wound healing complete.|||Participants|||Number
722534|NCT00324272|Secondary|Length of Time Drains Remain in Situ.|The duration of postoperative wound drainage was measured from the day of surgery until the the date of removal of the last wound drain.|From date of surgery until date of wound drain removal.|||Days||95% Confidence Interval|Median
722535|NCT00324272|Secondary|Length of Hospital Inpatient Stay.|The length of hospital stay was calculated from the day of surgery to the day that the patient was discharged from hospital.|From date of surgery until date of discharge from hospital.|As the length of hospital stay was affected by numerous factors other than those related to the surgery itself (e.g. the patient's social circumstances), the results for this secondary outcome measure have not been presented.||Days||Standard Deviation|Mean
722536|NCT00324272|Primary|Post-operative Wound Drainage.|The postoperative wound drainage volume was measured from the day of surgery until the the date of removal of the last wound drain.|From date of surgery to date of wound drain removal (typically a period of approximately one week).|||ml||95% Confidence Interval|Median
722537|NCT00324350|Secondary|Number of Participants With > 2 cm of Height Loss|Standing height was measured according to a standard protocol at baseline and annual visits on all ACCORD participants. Height loss was compared by treatment assignment using linear mixed models with random intercepts and slopes. Treatment effects were captured by the interaction between treatment assignment and time. The proportions losing >2 cm of height during follow-up were compared using logistic models. This degree of height loss is associated with incident vertebral fracture with 94% specificity but only 28% sensitivity|5 years|Among participants in the BONE ancillary study, 6,979 participants had at least one height measurement during follow-up and were included in these analyses.||participants|||Number
722538|NCT00324350|Primary|Number of Participants With at Least One Fall|At each annual visit starting in January 2006, participants were also asked about falling: “In the last 12 months have you fallen and landed on the floor or ground, OR fallen and hit an object like a table or stair?” Those who answered “yes” were also asked how many times they had fallen in the previous 12 months.|Average follow-up of 2.0 years|These analyses include results from the annual visits that occurred before Feb 5, 2008, the close of the intensive glycemia arm. Of those in the BONE ancillary study, 6,782 participants answered at least one question about falls.||participants|||Number
722539|NCT00324350|Primary|Number of Participants With at Least One Non-vertebral Fracture|The BONE ancillary study was initiated during recruitment for the main ACCORD trial. Beginning in January 2006, at the next annual visit participants were asked about the occurrence of any non-spine fractures since randomization. After the annual visit in 2006, participants were asked if they had suffered a fracture since their last annual visit. Reported fracture events were centrally adjudicated, based on radiology records, at the University of California, San Francisco (UCSF) with the adjudicators blinded to treatment assignment.|Average follow-up of 3.8 years|As per protocol, pathological fractures, confirmed as occurring secondary to neoplasm, necrosis, or sepsis, and periprosthetic fractures were excluded (N=7). These analyses are limited to confirmed fractures that occurred on or before Feb 5, 2008, when the intensive glycemia intervention was ended.||participants|||Number
722540|NCT00324415|Secondary|Objective Response Rate (Complete and Partial)|Number of participants with complete and partial responses based on the RECIST criteria|3 years following treatment discontinuation|||participants|||Number
722541|NCT00324415|Secondary|Anogenital Human Papilloma Virus (HPV) Infection and Anal Cytology||6 months following treatment discontinuation||||||
722542|NCT00324415|Secondary|Incidence of Opportunistic Illnesses|Incidence of opportunistic illnesses, including the development of AIDS during and for 1 year after completion of study treatment|1 year following treatment discontinuation|||participants|||Number
722543|NCT00324415|Secondary|Changes in CD4 Counts During and for 1 Year After Completion of Study Treatment|Change in absolute CD4 counts from start of treatment to 1 year after completion of study treatment|1 year following treatment discontinuation|The number of participants analyzed is the number for whom absolute CD4 count data were available at baseline at at 1 year after study completion||cells/mm3||Full Range|Median
722545|NCT00324415|Secondary|Quality of Life|EORTC QLQ-C30 Global Score at 1 year. The EORTC QLQ-C30 is a validated questionnaire that evaluates quality of life. The global score is an overall score for quality of life that ranges from 0 to 100. Higher scores indicate between quality of life|1 year|The number of participants analyzed is the number of participants for whom quality of life questionnaires were completed at one year.||units on a scale||Standard Deviation|Mean
722546|NCT00324415|Secondary|Overall Survival|Percentage of participants who are alive at one year|1 year|||percentage of participants||95% Confidence Interval|Number
722547|NCT00324415|Secondary|Colostomy-free Survival at 1 Year|Percentage of participants who are alive and have not had a colostomy|1 year|||percentage of participants||95% Confidence Interval|Number
722548|NCT00324415|Secondary|Relapse-free Survival|Percentage of participants who are alive and have not experienced progressive disease and have not relapsed|1 year|||percentage of participants||95% Confidence Interval|Number
722549|NCT00324415|Secondary|Progression-free Survival|Progression-free survival at 1 year is the percentage of patients who are alive and have not experienced progressive disease, defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started, or the appearance of one or more new lesions.|1 year|||percentage of participants||95% Confidence Interval|Number
722550|NCT00324415|Primary|Local Failure Rate at 3 Years|Patients will be classified into two groups for purposes of primary endpoint analysis: failure or no failure at 3 years (in the primary analysis, patients lost to follow-up prior to 3 years will be considered failures). For the secondary endpoint of objective response, patients will be classified as responders|3 years following treatment discontinuation|||participants|||Number
722551|NCT00325468|Secondary|Serum C-Telopeptide Percent Change From Parent Study 20010223 Baseline to Year 8||8 years|Subjects with nonmissing value at parent study 20010223 baseline and Year 8||percent||Inter-Quartile Range|Median
722552|NCT00325468|Primary|Distal 1/3 Radius Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8||8 years|Subjects with nonmissing value at parent study 20010223 baseline and Year 8||percent||95% Confidence Interval|Least Squares Mean
722553|NCT00325468|Primary|Total Hip Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8||8 years|Subjects with nonmissing value at parent study 20010223 baseline and Year 8||percent||95% Confidence Interval|Least Squares Mean
722554|NCT00325468|Secondary|Bone-Specific Alkaline Phosphatase Percent Change From Parent Study 20010223 Baseline to Year 8||8 years|Subjects with nonmissing value at parent study 20010223 baseline and Year 8||percent||Inter-Quartile Range|Median
722555|NCT00325468|Primary|Lumbar Spine Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8||8 years|Subjects with nonmissing value at parent study 20010223 baseline and Year 8||percent||95% Confidence Interval|Least Squares Mean
722556|NCT00325598|Secondary|Distant Control Rate||Up to 5 years||04/2018||||
722557|NCT00325598|Secondary|Regional Control Rate||Up to 5 years||04/2018||||
722558|NCT00325598|Secondary|Local Control Rate||Up to 5 years||04/2018||||
722559|NCT00325598|Secondary|Cosmetic Outcome||Up to 5 years||04/2018||||
722560|NCT00325598|Secondary|Incidence of Fat Necrosis||Up to 5 years||04/2018||||
722561|NCT00325598|Secondary|Incidence of Breast Fibrosis||Up to 5 years||04/2018||||
722562|NCT00325598|Secondary|Incidence and Severity of Cutaneous Toxicity||Up to 5 years||04/2018||||
722563|NCT00325598|Primary|Feasibility of PBI Directed External Radiotherapy as Measured by Development of Histological Fat Necrosis or Other Grade 4 Skin or Grade 4 Subcutaneous Toxicity, or Requires Surgery for the Skin/Subcutaneous Toxicity|-The study will be deemed infeasible if more than 4 patients develop histological fat necrosis or other grade 4 skin or grade 4 subcutaneous toxicity, or requires surgery for her skin or subcutaneous toxicity|Within 1 year of protocol registration|||percentage of participants|||Number
722564|NCT00325598|Primary|Feasibility of PBI Directed External Radiotherapy as Measured by Percentage of Participants Achieving a Dosimetrically Satisfactory Treatment Plan|-The study will be deemed infeasible if more than 4 patients cannot be given treatment because her tumor is such that a dosimetrically satisfactory treatment plan cannot be devised for her.|Within 1 year of protocol registration|||percentage of participants|||Number
722565|NCT00325754|Secondary|Mid-day Activity Monitoring at 6 Months|Physical activity was monitored for 3 weeks before the 6-month visit using tri-axial accelerometers worn on a waist belt. Activity is expressed in vector magnitude units (VMU, the vectorial sum of activity counts in three orthogonal directions) per minute. Mid-day defined as 10AM-4PM.). Mid-day defined as 10AM-4PM.|6 months|||Vector magnitude units (VMU)/min||Standard Deviation|Mean
722566|NCT00325754|Secondary|Average Mid-day Activity Monitoring at 3 Months|Physical activity was monitored for 3 weeks before the 3-month visit using tri-axial accelerometers worn on a waist belt. Activity is expressed in vector magnitude units (VMU, the vectorial sum of activity counts in three orthogonal directions) per minute. Mid-day defined as 10AM-4PM.|3 Months|||Vector magnitude units (VMU)/min||Standard Deviation|Mean
722567|NCT00325754|Primary|Stationary Oxygen Use Daily||Baseline|||Hours||Standard Deviation|Mean
722568|NCT00325754|Primary|Ambulatory/Portable Oxygen Use Daily||6 months|||Hours||Standard Deviation|Mean
722569|NCT00325754|Primary|Stationary Oxygen Use Daily||6 Months|||Hours||Standard Deviation|Mean
722570|NCT00325780|Secondary|Change From Baseline in Total Cholesterol|Mean percent change from baseline in total cholesterol|Baseline to 52 weeks|Patients who had an observation at Week 52||percent change||Standard Deviation|Mean
722571|NCT00325780|Primary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)|Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C)|Baseline to 52 Weeks|Patients who had an observation at Week 52||percent change||Standard Deviation|Mean
722657|NCT00326716|Primary|Infant Gestational Age at Delivery||At the time of delivery|All infants.||Weeks||Standard Error|Mean
722580|NCT00325897|Secondary|Incidence of Macrolide-resistant Bacterial Colonization of the Nasopharynx or Sputum|Cultures from some participants who were not colonized with selected respiratory pathogens at the time of enrollment but who became colonized during the course of the study were available for susceptibility testing for the incidence of macrolide-resistant bacterial colonization.|During Course of Study (either month 3, 6, 9, or 12)|Using cultures from participants who were not colonized with selected respiratory pathogens at the time of enrollment but who became colonized during the course of the study, samples were available from 68% of the participants in the azithromycin group and 70% in the placebo group among these cultures.||participants|||Number
722581|NCT00325897|Secondary|Incidence of Macrolide-resistant Bacterial Colonization of the Nasopharynx or Sputum|Cultures from 68% of the participants in the azithromycin group and 70% in the placebo group who were not colonized with selected respiratory pathogens at the time of enrollment but who became colonized during the course of the study were available for susceptibility testing for the incidence of macrolide-resistant bacterial colonization.|Baseline|Using cultures from participants who were not colonized with selected respiratory pathogens at the time of enrollment but who became colonized during the course of the study, samples were available from 68% of the participants in the azithromycin group and 70% in the placebo group among these cultures.||Participants|||Number
722582|NCT00325897|Secondary|Change in Age-adjusted Hearing Threshold|Assessed by audiometry for four sound frequencies (1000, 2000, 3000, 4000 Hz). The maximum was computed for each threshold in each ear for all frequencies, then the differences between visits were assessed.|Baseline and 12 months|Participants with both baseline and one-year audiometry data available were analyzed.||Decibels (db)||Standard Deviation|Mean
722583|NCT00325897|Secondary|Number of Hospital Admissions as a Result of Acute Exacerbations||Measured monthly for 12 months|||Hospitalizations|||Number
722584|NCT00325897|Secondary|Number of Emergency Department Visits as a Result of Acute Exacerbations||Measured monthly for 12 months|||Visits|||Number
722585|NCT00325897|Secondary|Exacerbations/Patient Year|"Acute exacerbations are defined as a complex of respiratory symptoms (increase or new onset) of more than one of the following: cough, sputum, wheezing, dyspnea, or chest tightness with a duration of at least three days requiring treatment with antibiotics and/or systemic steroids "|Measured monthly until 13 months|Participants with any follow-up data were analyzed.||exacerbations/patient year|||Number
722586|NCT00325897|Primary|Time Until First Occurrence of Acute Chronic Obstructive Pulmonary Disease (COPD) Exacerbation|"Time until first occurrence of acute Chronic Obstructive Pulmonary Disease (COPD) exacerbation. Acute exacerbations are defined as a complex of respiratory symptoms (increase or new onset) of more than one of the following: cough, sputum, wheezing, dyspnea, or chest tightness with a duration of at least three days requiring treatment with antibiotics and/or systemic steroids "|Measured monthly through 13 months|Participants that had any follow-up data were included in analysis.||Days||95% Confidence Interval|Median
722587|NCT00326001|Secondary|Number of Patients With Charred Catheter Tips|Char or coagulum formation on the catheter tip|ablation procedure|per protocol||Patients|||Number
722588|NCT00326001|Secondary|Number of Patients With Long-term Treatment Success|No recurrence of atrial flutter after ablation|6 months after ablation|per protocol||Patients|||Number
722589|NCT00326001|Secondary|Ablation Success With the First Catheter|"Delivery of radiofrequency current was repeated until a cavotricuspid isthmus (CTI) conduction block was detected. The final bidirectional CTI block test (well documented in the literature) was performed 20 minutes after the last radiofrequency current delivery to assess ablation success (Y/N).
Positive final bidirectional cavotricuspid isthmus condution block test means ablation successful.
Negative final bidirectional cavotricuspid isthmus condution block test means ablation unsuccessful; ablation should be continued until success or terminated and classified as unsuccess."|ablation procedure|per protocol||Patients|||Number
722590|NCT00326001|Primary|Duration of Energy Application|Cumulative amount of time current is flowing through the catheter tip. The current (in the radiofrequency range) is applied to ablate the cavotricuspid isthmus in the right atrium.|ablation procedure|Per protocol||minute||Standard Deviation|Mean
722786|NCT00327717|Secondary|The Mean Percent Change From Baseline in Simple Partial (SP) Seizure Frequency|The Mean percent change in seizure frequency of SP from baseline during the fixed-dose phase.|Baseline and 16 weeks|FAS Population. Simple partial seizure patients||Percent Change||Standard Deviation|Mean
722591|NCT00326118|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|"A serious adverse event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject.
For the long-term persistence phase (Years 1 through 5), only those SAEs that are determined by the investigator to have a causal relationship to the vaccination will be described individually."|Throughout the entire study period (up to year 5)|Analysis was performed on vaccinated subjects from the Total Vaccinated Cohort for the Vaccination Phase of the study (up to Month 1) and on the Total Enrolled Cohort up to Year 5, which included all vaccinated subjects in the vaccination phase who came back for the Year 1, Year 2, Year 3 ,Year 4 and/or Year 5 persistence phases of the study.||Subjects|||Number
722592|NCT00326118|Secondary|Number of Subjects Reporting Unsolicited Symptoms|Unsolicited symptom: Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.|Within 31 days (Day 0 - Day 30) after vaccination|Analysis was performed on the Total Vaccinated Cohort, on vaccinated subjects with available data for the vaccination phase.||Subjects|||Number
722593|NCT00326118|Secondary|Number of Subjects Reporting Solicited Local and General Symptoms|"Solicited local symptoms assessed include pain, redness and swelling at the injection site.
Solicited general symptoms assessed include drowsiness, fever (≥ 38°C), irritability and loss of appetite."|Within 4 days (Day 0 -Day 3) after vaccination|Analysis was performed on the Total Vaccinated Cohort, on vaccinated subjects with available data for the vaccination phase.||Subjects|||Number
722594|NCT00326118|Secondary|Anti-polysaccharide C (Anti-PSC) Antibody Concentrations|Concentrations given as Geometric Mean Concentrations (GMCs).|Prior to, 1 month, 1 year, 2 years and 3 years after vaccination|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity (prior to and 1 month after vaccination) and the ATP cohort for analysis of persistence for Year 1, 2, 3 (1, 2, 3 years after vaccination), on subjects with available data for at least one tested antigen at the considered time point.||micrograms per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
722595|NCT00326118|Secondary|Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Above the Cut-off Values|Anti-PSC antibody concentration cut-off values assessed include greater than or equal to (≥) 0.30 µg/mL and ≥ 2.0 µg/mL.|Prior to, 1 month, 1 year, 2 years and 3 years after vaccination|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity (prior to and 1 month after vaccination) and the ATP cohort for analysis of persistence for Year 1, 2, 3 (1, 2, 3 years after vaccination), on subjects with available data for at least one tested antigen at the considered time point.||Subjects|||Number
722596|NCT00326118|Secondary|Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations|Concentrations are given as Geometric Mean Concentrations (GMCs).|5 years after vaccination|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 5, on subjects with available data for at least one tested antigen at the considered time point.||microgram per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
722597|NCT00326118|Secondary|Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations|Concentrations are given as Geometric Mean Concentrations (GMCs).|Prior to, 1 month , 1 year, 2 years, 3 years and 4 years after vaccination|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity (prior to and 1 month after vaccination) and the ATP cohort for analysis of persistence for Year 1, 2, 3 and 4 (1, 2, 3 and 4 years after vaccination), on subjects with available data for at least one tested antigen at the considered time point.||microgram per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
722598|NCT00326118|Secondary|Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values|Anti-PRP antibody concentration cut-off values assessed include 0.15 µg/mL (indicative of short-term protection) and 1.0 µg/mL (indicative of long-term protection).|5 years after vaccination|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 5, on subjects with available data for at least one tested antigen at the considered time point.||Subjects|||Number
722599|NCT00326118|Secondary|Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values|Anti-PRP antibody concentration cut-off values assessed include 0.15 µg/mL (indicative of short-term protection) and 1.0 µg/mL (indicative of long-term protection).|Prior to, 1 month, 1 year, 2 years, 3 years and 4 years after vaccination|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity (prior to and 1 month after vaccination) and the ATP cohort for analysis of persistence for Year 1, 2, 3 and 4 (1, 2, 3 and 4 years after vaccination), on subjects with available data for at least one tested antigen at the considered time point.||Subjects|||Number
722600|NCT00326118|Secondary|Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers|Titers are given as Geometric Mean Titers (GMTs). Functional anti-meningococcal serogroup C activity (SBA-MenC) was determined by a serum bactericidal test using rabbit complement. For SBA testing at the PHE at Year 5, titres were expressed as the reciprocal of the last dilution resulting in at least 50% inhibition.|5 years after vaccination|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 5, on subjects with available data for at least one tested antigen at the considered time point.||Titer||95% Confidence Interval|Geometric Mean
722601|NCT00326118|Secondary|Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers|Titers are given as Geometric Mean Titers (GMTs). Functional anti-meningococcal serogroup C activity (SBA-MenC) was determined by a serum bactericidal test using rabbit complement. For SBA testing at a GlaxoSmithKline (GSK) laboratory up to Year 3 after vaccination, titres were expressed as the reciprocal of the dilution resulting in 50% inhibition. For SBA testing at the PHE at year 4 after vaccination, titres were expressed as the reciprocal of the last dilution resulting in at least 50% inhibition.|Prior to, 1 month, 1 year, 2 years, 3 years and 4 years after vaccination.|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity (prior to and 1 month after vaccination) and the ATP cohort for analysis of persistence for Year 1, 2, 3 and 4 (1, 2, 3 and 4 years after vaccination), on subjects with available data for at least one tested antigen at the considered time point.||Titer||95% Confidence Interval|Geometric Mean
723039|NCT00320788|Primary|Mean Change of CR/LT From Baseline at Week 12|CR/LT measured in micrometers (µm); lower individual values represent better outcomes.|Baseline and at Week 12|Full Analysis Set (FAS) used for analysis, Last Observation Carried Forward (LOCF)||μm||Standard Deviation|Mean
722602|NCT00326118|Secondary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Above the Cut-off Values|rSBA-MenC titers cut-off values assessed were greater than or equal to (≥)1:8 (indicative of seroprotection) and 1:128 titers. For SBA testing at the PHE at Year 5, titres were expressed as the reciprocal of the last dilution resulting in at least 50% inhibition.|5 years after vaccination|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 5, on subjects with available data for at least one tested antigen at the considered time point.||Subjects|||Number
722603|NCT00326118|Secondary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Above the Cut-off Values|"rSBA-MenC titers cut-off values assessed were greater than or equal to (≥) 1:8 (indicative of seroprotection) and ≥ 1:128 titers.
Functional anti-meningococcal serogroup C activity (SBA-MenC) was determined by a serum bactericidal test using rabbit complement. For SBA testing at a GlaxoSmithKline (GSK) laboratory up to Year 3 after vaccination, titres were expressed as the reciprocal of the dilution resulting in 50% inhibition. For SBA testing at the Public Health England (PHE), formerly known as Health Protection Agency (HPA), at Year 4, titres were expressed as the reciprocal of the last dilution resulting in at least 50% inhibition."|Prior to, 1 month, 1 year, 2 years, 3 years and 4 years after vaccination|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity (prior to and 1 month after vaccination) and the ATP cohort for analysis of persistence for Year 1, 2, 3 and 4 (1, 2, 3 and 4 years after vaccination), on subjects with available data for at least one tested antigen at the considered time point.||Subjects|||Number
722604|NCT00326118|Primary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Greater Than or Equal to 1:8 Titer|rSBA-MenC titers greater than or equal to 1:8 titer are indicative of seroprotection.|1 month after vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity which included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component for the blood sample taken 1 month after vaccination.||Subjects|||Number
722605|NCT00326118|Primary|Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 0.15 Micrograms Per Milliliter (µg/mL)|Anti-PRP antibody concentration greater than or equal to 0.15 µg/mL is indicative of short-term protection.|1 month after vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity which included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component for the blood sample taken 1 month after vaccination.||Subjects|||Number
722606|NCT00326170|Primary|Number of Participants With Response|Clinical activity of combination defined as: Complete Response (CR), bone marrow with 5% or fewer blasts and peripheral blood count with an absolute neutrophil count of 10^9/L or more and platelet count of 100x10^9 or more; Complete response without platelets (CRp), a complete response except for a platelet count less than 100x10^9 and transfusion independent; and Bone Marrow (BM) Response, bone marrow blast of 5% or less but without meeting the peripheral blood count criteria for (CR) or (CRp).|Up to 12 cycles of treatment (28 day cycles)|||Participants|||Number
722607|NCT00326183|Primary|Participants With Elevated Temperature (>=102.2F/39.0C)||Days 1 to 5 After Any Vaccination|Includes all subjects who provided body temperature follow-up data after any dose of vaccine.||participants|||Number
722608|NCT00326183|Primary|Participants With Varicella/Zoster-Like Rash After Second Vaccination||Days 1 to 28 After Second Vaccination|Includes all subjects who provided safety follow-up data after the second vaccinations were administered. Only the VAQTA™ + ProQuad™ group was followed for rashes.||participants|||Number
722609|NCT00326183|Primary|Participants With Varicella/Zoster-Like Rash After First Vaccination||Days 1 to 28 After First Vaccination|Includes all subjects who provided safety follow-up data after the first vaccinations were administered. Only the VAQTA™ + ProQuad™ group was followed for rashes.||participants|||Number
722610|NCT00326183|Primary|Participants With Rubella-Like Rash After Second Vaccination||Days 1 to 28 After Second Vaccination|Includes all subjects who provided safety follow-up data after the second vaccinations were administered. Only the VAQTA™ + ProQuad™ group was followed for rashes.||participants|||Number
722611|NCT00326183|Primary|Participants With Rubella-Like Rash After First Vaccination||Days 1 to 28 After First Vaccination|Includes all subjects who provided safety follow-up data after the first vaccinations were administered. Only the VAQTA™ + ProQuad™ group was followed for rashes.||participants|||Number
722612|NCT00326183|Primary|Participants With Mumps-Like Symptoms After Second Vaccination||Days 1 to 28 After Second Vaccination|Includes all subjects who provided safety follow-up data after the second vaccinations were administered. Only the VAQTA™ + ProQuad™ group was followed for mumps-like symptoms.||participants|||Number
722613|NCT00326183|Primary|Participants With Mumps-Like Symptoms After First Vaccination||Days 1 to 28 After First Vaccination|Includes all subjects who provided safety follow-up data after the first vaccinations were administered. Only the VAQTA™ + ProQuad™ group was followed for mumps-like symptoms.||participants|||Number
722614|NCT00326183|Primary|Participants With Measles-Like Rash After Second Vaccination||Days 1 to 28 After Second Vaccination|Includes all subjects who provided safety follow-up data after the second vaccinations were administered. Only the VAQTA™ + ProQuad™ group was followed for rashes.||participants|||Number
722615|NCT00326183|Primary|Participants With Measles-Like Rash After First Vaccination||Days 1 to 28 After First Vaccination|Includes all subjects who provided safety follow-up data after the first vaccinations were administered. Only the VAQTA™ +ProQuad™ group was followed for rashes.||participants|||Number
722616|NCT00326183|Primary|Participants With 1 or More Injection-Site Adverse Experiences||Days 1 to 14 after any vaccination|Includes all subjects who provided safety follow-up data after any dose of vaccine out of the total number of subjects enrolled.||participants|||Number
722617|NCT00326183|Secondary|Participants With 1 or More Systemic Adverse Experiences||Days 1 to 14 After Any Vaccination|Includes all subjects who provided safety follow-up data after any dose of vaccine out of the total number of subjects enrolled.||participants|||Number
722618|NCT00326183|Primary|Participants With 1 or More Serious Vaccine-Related Adverse Experiences||Days 1 to 14 after any vaccination|Includes all subjects who provided safety follow-up data after any dose of vaccine out of the total number of subjects enrolled.||participants|||Number
722619|NCT00326196|Primary|The Hypothesis Being Tested is That a Strategy of Initial Surgical Revascularization is Superior to Percutaneous Intervention in Preventing Death or Myocardial Infarction in Diabetics With Severe Ischemic Heart Disease Assessed up to 4 Years.|Participants were monitored for up to 4 years. This is the number of particiapnts who have died or had at least one myocardial infarction.|Date of Death and non-fatal MI|The number of participants for analysis was determined by intent to treat principal.||participants|||Number
722625|NCT00326495|Secondary|Count of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|96 months, 26 days|Although 51 patients were accrued, only 50 were on study long enough for assessment.||Participants|||Count of Participants
722626|NCT00326495|Primary|Overall Rate of Response|Rate of response is defined as the percentage of participants with a complete response (CR) + partial response (PR) + stable disease (SD) for 4 months. Response is defined by the Response is determined by the Response Evaluation Criteria in Solid Tumors (RECIST). Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Complete response is a disappearance of all target lesions. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (progressive disease), taking as reference the smallest sum LD since the treatment started. Progressive disease is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|4 months|Although 51 patients were accrued, only 50 were on study long enough for assessment.||percentage of participants|||Number
722627|NCT00326599|Secondary|Dose Limiting Toxicity (DLT) (Lead-in Phase Arm I Patients Only)|DLT was defined as an adverse event occurring in cycle 1 only, at least possibly attributed to the study treatment and meeting the following criteria: 1) Grade 4 absolute neutrophil count (ANC) >5 days or of any duration with fever >38.5 degree Celsius; 2) Grade 4 platelet count; 3) Grade 3 or higher non-hematologic toxicities (for nausea, vomiting or diarrhea, grade 3 toxicities will be DLT if they occur despite maximal use of anti-emetic support or anti-diarrhea agents, respectively); 4) Cediranib dose interruption of >14 days for drug-related toxicities.|Cycle 1 (up to 3 weeks)|The first 6 participants treated on Arm I (lead-in phase).||participants|||Number
722628|NCT00326599|Secondary|Overall Survival (Phase II Patients Only)|Overall survival was defined as the time from study enrollment to the time of death from any cause. Overall survival will be censored at the date of the last follow-up visit for patients who are still alive or lost to follow-up.|Up to 5 years|All phase II participants who met eligibility criteria and started the treatment.||months||95% Confidence Interval|Median
722629|NCT00326599|Secondary|Overall Survival at 1 Year After Randomization (Phase II Patients Only)|Overall survival was defined as the time from study enrollment to the time of death from any cause. A patient is classified as a success if alive at 1 year.|1 year|All phase II participants who met eligibility criteria and started the treatment.||percentage of participants||95% Confidence Interval|Number
722630|NCT00326599|Secondary|Time to Treatment Failure (Phase II Patients Only)|Time to treatment failure was defined to be the time from date of registration to the date at which the patient was removed from the treatment due to progression, toxicity, refusal or death from any cause.|Up to 15 months|All phase II participants who met the eligibility criteria and have ended the study treatment.||months||95% Confidence Interval|Median
722631|NCT00326599|Secondary|Progression-free Survival (Phase II Patients Only)|Progression-free survival was defined as the time from study enrollment to the first date of disease progression or death as a result of any cause, whichever occurs first. Progression-free survival will be censored at the date of the last contact for patients who are still alive and who have not had disease progression.|Up to 5 years|All phase II participants who met eligibility criteria and have received at least one cycle of treatment.||months||95% Confidence Interval|Median
722632|NCT00326599|Secondary|Progression-free Survival Rate at 6 Months After Randomization (Phase II Patients Only)|"Estimated using the Binomial point estimator (number of successes divided by the total number of evaluable patients). A patient is classified as a success if alive and progression-free at 6 months.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions."|6 months|All phase II participants who met eligibility criteria and have received at least one cycle of treatment.||percentage of participants||95% Confidence Interval|Number
722658|NCT00326716|Secondary|SAEs in Enrolled Infants|SAEs were evaluated for all treated and untreated participants. An SAE was defined as an untoward medical occurrence that results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event); might have caused death if it were more severe, required inpatient hospitalization or prolongation of existing hospitalization, in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, an important medical event that required intervention to prevent serious outcomes.|Birth Through Week 16 of Life|SAEs were recorded for all enrolled infants.||Participants|||Number
722633|NCT00326599|Primary|Confirmed Response Rate (Complete Response and Partial Response) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) (Phase II Patients Only)|"A confirmed tumor response was defined as a complete response (CR) or partial response (PR) noted as the objective status on 2 consecutive evaluations at least 6 weeks apart.
Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria:
Complete Response (CR): disappearance of all target lesions;
Partial Response (PR) 30% decrease in sum of longest diameter of target lesions"|Up to 5 years|All phase II participants who met eligibility criteria and have received at least one cycle of treatment.||percentage of participants||95% Confidence Interval|Number
722634|NCT00326612|Secondary|Respiratory Depression Requiring Oxygen at Discharge From the Emergency Department.|Respiratory depression was defined as requiring oxygen at discharge from the Emergency Department.|24 hours|Analysis was per protocol||participants|||Number
722635|NCT00326612|Secondary|Number of Patients Who Had a Repeat Seizure Within 12 Hours After Their Seizure Who Used Study Medication||12 hours|||participants|||Number
722636|NCT00326612|Secondary|Number of Patients That Were Admitted to the Hospital After Their Seizure and Use of Study Medication.||24 hours|||participants|||Number
722637|NCT00326612|Secondary|Number of Patients Needed to be Seen or Treated in the Emergency Department for Their Seizure and Use of Study Medication.||24 hours|||participants|||Number
722638|NCT00326612|Secondary|Number of Patients Who Needed Additional Medication to Treat the Seizure in the Emergency Department Within 24 Hours||24 hours|||participants|||Number
722639|NCT00326612|Secondary|Respiratory Depression Requiring Intubation|Respiratory depression was defined as intubation at Emergency Department discharge.|24 hours|Analysis was per protocol||participants|||Number
722640|NCT00326612|Primary|Length of Seizure After Study Medication Administration|Length of seizure.|24 hours|Analysis was per protocol||Minutes||Inter-Quartile Range|Median
722641|NCT00326716|Primary|Mean RTV Time of Maximum Observed Plasma Concentration (Tmax)|Tmax = time to reach the maximum observed plasma concentration of ritonavir at specified time points.|Pregnancy Weeks 12 to 28, Weeks 28 to 36, and 4-6 Weeks Postpartum|Treated participants in the PK concentration data set.||Hours||95% Confidence Interval|Geometric Mean
722642|NCT00326716|Primary|Mean ATV Time of Maximum Observed Plasma Concentration (Tmax)|Tmax = time to reach maximum observed plasma concentration of atazanavir at specified time points.|Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum|Treated participants in the PK concentration data set.||Hours||95% Confidence Interval|Geometric Mean
722643|NCT00326716|Primary|Mean RTV Terminal Elimination Half Life (T 1/2)|T 1/2 = terminal elimination half life of ritonavir at specified time points.|Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum|Treated participants in the PK concentration data set||Hours||95% Confidence Interval|Geometric Mean
722644|NCT00326716|Secondary|Multicenter AIDS Cohort Study (MACS) Participant Adherence to Regimen and Drug Components for ATV 300 mg / RTV 100 mg Test Dose|The MACS was administered to evaluate participant adherence to each drug and the adherence to the regimen. The MACS adherence questionnaire asks patients how many medication doses they missed during the previous day, 2 days, 3 days and 4 days. Drug-specific questions included adherence with dose and frequency. Adherence was defined as taking all doses and numbers of pills as prescribed for each medication. This strict adherence cut-off was based on the guidelines stating that anything less than excellent adherence may result in a virus breakthrough and development of resistance.|Study Week 2, Pregnancy Weeks 20 to Weeks 28, Pregnancy Weeks 28 to Delivery, Week 2 Postpartum, Week 4 Postpartum|All treated participants were included in this evaluation.||Participants|||Number
722645|NCT00326716|Secondary|Mean Atazanavir Plasma Protein Binding|Atazanavir Plasma Protein Binding Percentage measured at specified time points.|Pregnancy Weeks 28 to Delivery at 3 Hours Postdose and 24 Hours Postdose, and Time of Delivery|||Percentage Bound||Standard Deviation|Mean
722646|NCT00326716|Secondary|Median Infant Total Bilirubin Level|Median infant total bilirubin level as measured at specified time points.|Birth (Day 1), Day 3, Day 5, and Day 7 of Life|||mg / dL||Inter-Quartile Range|Median
722647|NCT00326716|Secondary|Mean Atazanavir Maternal Plasma Concentration and Neonatal Cord Blood Concentration|Mean atazanavir maternal plasma concentration and neonatal cord blood concentration as measured at the time of delivery.|At Time of Delivery|||ng / mL||Standard Deviation|Mean
722648|NCT00326716|Primary|Mean ATV Terminal Elimination Half Life (T 1/2)|T 1/2 = terminal elimination half life of atazanavir at specified time points.|Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum|Treated participants in the PK concentration data set.||Hours||95% Confidence Interval|Geometric Mean
722649|NCT00326716|Primary|Mean RTV Trough Plasma Concentration (Cmin) 24 Hours Following the Daily Dose|Cmin = plasma concentration 24 hours post dose of ritonavir at specified time points.|Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum at 24 hours following the daily dose.|Treated participants in the PK concentration data set.||ng•h / mL||95% Confidence Interval|Geometric Mean
722650|NCT00326716|Primary|Mean ATV Trough Plasma Concentration (Cmin) 24 Hours Following the Daily Dose|Cmin = plasma concentration 24 hours post dose of atazanavir at specified time points.|Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum at 24 hours following the daily dose.|Treated participants in the PK concentration data set.||ng•h / mL||95% Confidence Interval|Geometric Mean
722651|NCT00326716|Primary|Mean RTV Area Under the Concentration Curve (AUC TAU)|AUC = area under the concentration curve (AUC [TAU]) of ritonavir in one dosing interval.|Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum|Treated participants in the PK concentration data set.||ng•h / mL||95% Confidence Interval|Geometric Mean
722652|NCT00326716|Primary|Mean ATV Area Under the Concentration Curve (AUC TAU)|AUC = area under the concentration curve (AUC [TAU]) of atazanavir in one dosing interval from time zero to 24 hours.|Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum|Treated participants in the PK concentration data set.||ng•h / mL||95% Confidence Interval|Geometric Mean
722653|NCT00326716|Primary|Mean RTV Maximum Plasma Concentration (Cmax) in One Dosing Interval|Cmax = maximum observed plasma concentration of ritonavir at specified time points.|Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum|Treated participants in the PK concentration data set.||ng / mL||95% Confidence Interval|Geometric Mean
722654|NCT00326716|Primary|Mean ATV Maximum Plasma Concentration (Cmax) in One Dosing Interval|Cmax = maximum observed plasma concentration of atazanavir at specified time points.|Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum|Treated participants in the pharmacokinetic (PK) concentration data set.||ng / mL||95% Confidence Interval|Geometric Mean
722659|NCT00326716|Secondary|SAEs in Enrolled Mothers|SAEs were evaluated for all treated and untreated participants. An SAE was defined as an untoward medical occurrence that results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event); might have caused death if it were more severe, required inpatient hospitalization or prolongation of existing hospitalization, in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, an important medical event that required intervention to prevent serious outcomes.|During Study Period and 30 Days Post-Study.|Data were analyzed for all treated and untreated mothers.||Participants|||Number
722660|NCT00326716|Secondary|Number of Participants With Grade 2 to Grade 4 AEs and SAEs|AEs and SAEs considered possibly, probably, or certainly related to study treatment, were graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death). Hyperbilirubinemia (Grade 1=1.1 to 1.5 upper limit of normal [ULN] [mild], Grade 2=1.6 to 2.5 ULN [moderate], Grade 3=2.6 to 5.0 ULN [severe], Grade 4= > 5.0 ULN [potentially life threatening]).|During Study Period and 30 Days Post-Study.|Data were pooled from the ATV 300 mg / RTV 100 mg and ATV 400 mg / RTV 100 mg groups for all treated mothers and all infants. The number of AEs and SAEs is based on enrolled participants.||Participants|||Number
722661|NCT00326716|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE =any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|During study period and 30 days post-study.|The number of SAEs is based on enrolled participants. Data were pooled from the ATV 300 mg / RTV 100 mg and ATV 400 mg / RTV 100 mg groups for all treated mothers and all infants.||Participants|||Number
722662|NCT00326716|Secondary|Infant HIV Status|The neonatal HIV-1 status are assessed by the Roche Amplicor HIV-1 DNA Assay Version 1.5 (Roche Molecular Systems).|Birth Through 6 Months on Study|All infants.||Participants|||Number
722663|NCT00326716|Secondary|Mean CD4 Cell Count at Baseline||Baseline|All treated participants.||cells / mm^3||Standard Error|Mean
722664|NCT00326716|Secondary|Median Change From Baseline to Day of Delivery in Maternal Cluster of Differentiation 4 (CD4) Cell Count|The median CD4 cell count change from baseline was calculated for all treated mothers at the time of delivery ± 2 days. Maternal CD4 cell counts were assessed by the Roche Amplicor® Ultrasensitive Assay Version 1.5.|Baseline, Day of Delivery ± 2 Days|The median CD4 Cell Count Change From Baseline was calculated based on all treated mothers. The maternal CD4 cell count at delivery was determined as the closest to delivery and within a pre-defined visit window for delivery, which is delivery date ± 2 days.||cells / mm^3||Inter-Quartile Range|Median
722665|NCT00326716|Secondary|Mean HIV RNA Level at Baseline||Baseline|All treated participants.||log10 cm / mL||Standard Error|Mean
722666|NCT00326716|Secondary|Median Change From Baseline to Day of Delivery in Maternal HIV RNA Level|The maternal HIV RNA level was determined at baseline and the day of delivery ± 2 days using VR-OC. The maternal HIV RNA level is assessed by the Roche Amplicor® Ultrasensitive Assay Version 1.5.|Baseline, Day of Delivery ± 2 Days|The median maternal HIV RNA Level Change From Baseline was calculated for all treated mothers at the time of delivery. The maternal HIV RNA level at delivery was determined as the closest to delivery and within a pre-defined visit window for delivery, which is delivery date ± 2 days.||log10 c / mL||Inter-Quartile Range|Median
722667|NCT00326716|Secondary|Maternal HIV Ribonucleic Acid (RNA) Level on Day of Delivery|The maternal HIV RNA level is assessed by the Roche Amplicor® Ultrasensitive Assay Version 1.5.|Day of Delivery ± 2 Days|The analysis for the proportion of HIV RNA < 400 and < 50 c/mL at delivery is based on the Virologic Response - Observed Cases (VR-OC). VR-OC classifies subjects who remain on study therapy as responders according to a single HIV RNA measurement < 400 c/mL (or < 50 c/mL) closest to delivery and within delivery date ± 2 days.||Participants|||Number
722668|NCT00326781|Secondary|Verified 7-day Point Prevalence Abstinence at End Of Treatment.|"End-of-Treatment (EOT) is defined as the phone survey that takes place at the end of each subject's nicotine replacement therapy treatment. The EOT took place up to 8 weeks after participants began the study and also utilized the Timeline Followback. It is a 7-day point prevalence measure describing a subject's ability to remain abstinent from smoking for the 7 previous days occurring before a subject's EOT phone survey.
This was verified by a Carbon Monoxide breath reading taking place within a week of a subject's End of Treatment phone survey."|End of Treatment|||participants|||Number
722669|NCT00326781|Primary|Continuous Abstinence at End of Treatment (Self-report)(Defined as the Number of Consecutive Days Without Smoking a Cigarette for Each Subject)|A self-report measure of continuous abstinence at end of treatment. It is defined as the number of consecutive days without smoking a cigarette for each subject, as determined by the Timeline Followback (TLFB), completed by research staff. The TLFB is an assessment tool that obtains estimates of daily smoking. Using a calendar, people provide retrospective estimates of their daily smoking over a specified time period that can vary up to 12 months from the interview date. The TLFB has also been used to assess other forms of substance abuse (e.g., alcohol, drugs, etc.).|End of Treatment (8-weeks after quit date)|Analysis was intention to treat (ITT)||Participants|||Number
722670|NCT00326872|Secondary|Reduction in Self Reported Worst Pain Per Cycle.|Reduction in self reported worst pain per cycle as measured by the Worst Pain scale from the North Central Cancer Treatment Group Brief Pain Inventory (short form). The worst pain scale is from 0-10 (10 is worst pain possible). The per-cycle average reduction in worst pain will be analyzed using generalized linear models to account for repeated measures within patients.|At baseline, prior to each subsequent course (q 28+/- 3 days), and at end of treatment up to 51 months|||units on a scale of 0-10||Standard Error|Mean
722687|NCT00326898|Other Pre-specified|The Relationship of Polymorphisms in Drug Metabolizing Enzymes With Steady State Concentrations of Sorafenib and Sunitinib in Selected Patients||Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry||||||
722688|NCT00326898|Other Pre-specified|The Association Between Deoxyribonucleic Acid (DNA) Methylation Profiles and Disease-free Survival||Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry||||||
722671|NCT00326872|Secondary|Time to Treatment Failure as Assessed Using the Method of Kaplan-Meier|"Time to treatment failure is defined to be the time from the date of randomization to the date at which the patient is removed from treatment due to progression, toxicity, or refusal. If the patient is considered to be a major treatment violation or is taken off study as a non-protocol failure, the patient will be censored on the date they are removed from treatment.
Time to treatment failure will be estimated using the method of Kaplan-Meier."|From the date of randomization to the date at which the patient is removed from treatment due to progression, toxicity, or refusal up to 51 months.|||Months||95% Confidence Interval|Median
722672|NCT00326872|Secondary|Duration of Response as Assessed Using the Method of Kaplan-Meier|Duration of response is defined for all evaluable patients who have achieved a confirmed tumor objective response as the date at which the patient’s objective status is first noted to be either a CR or PR to the date progression is documented. Duration of response will be estimated using the method of Kaplan-Meier.|From time of confirmed tumor objective response as CR or PR to the date of progression max 51 months|There was only 1 response and due to patient confidentiality we are not reporting this endpoint.|||||
722673|NCT00326872|Secondary|Time to Disease Progression as Measured Using Kaplan-Meier Method|"Progression (PD): At least a 20% increase in the sum of volumes of target lesions taking as reference the smallest volume recorded since the treatment started or the appearance of one or more new lesions.
If a patient dies without documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death."|From registration to documentation of disease progression up to 26 cycles (28 days/cycle).|||Months||95% Confidence Interval|Median
722674|NCT00326872|Secondary|Survival Time as Measured Using Kaplan-Meier Method|Survival time is defined as the time from registration to death due to any cause.|From registration to death (due to any cause) max 51 months|||Months||95% Confidence Interval|Median
722675|NCT00326872|Primary|Proportion of Patients With Tumor Response (Complete Response [CR] or Partial Response [PR])|"Complete Response (CR): Disappearance of all target lesions.
Partial Response (PR): At least a 30% decrease in the volume of target lesions taking as reference the baseline volume."|Baseline to end of treatment, maximum of 26 cycles (28 days/cycle).|||Proportion of patients||95% Confidence Interval|Number
722676|NCT00326885|Primary|Increase of Paracentesis/Puncture-free Interval (Ratio)|The parameter to be tested is the ratio of the post-treatment puncture/paracentesis-free interval divided by the pre-treatment puncture/paracentesis-free interval. The pre-treatment interval is defined as the length of time between the patient`s most recent paracentesis (baseline) and the subsequent paracentesis necessitated by her increasing ascites-related symptoms. The post-treatment interval is defined as the time between the last dose of catumaxomab plus 1 day to the time of recurrence of ascites requiring therapeutic paracentesis or death, whichever occurred sooner.|180 days|||fold||Full Range|Median
722677|NCT00326885|Secondary|Ascites Volume|Ascites volume measurement were to be performed at screening (= prior to baseline), at baseline (= before start of therapy with catumaxomab) and during the 6-month follow-up period when the patient had recurrence of symptomatic ascites requiring therapeutic paracentesis. At each paracentesis, drainage to dryness was to be achieved and the exact volume was to be measured and documented.|6 months|||mL||Full Range|Median
722678|NCT00326885|Secondary|Ascites Signs and Symptoms|"Patient-reported ascites symptoms were to be assessed using the patient questionnaire, Functional Assessment of Chronic Illness Therapy – Ascites Index (FACIT-AI). At 6 months following catumaxomab administration, the patient was requested to assess the severity of the following parameters during the past week using a 5-point scale with scores from 0 = not at all to 4 = very much: anorexia, insomnia, decreased mobility, dyspnea, nausea, vomiting, abdominal pain, abdominal distention, fatigue, early satiety, urinary frequency, constipation, and emotional distress. For the parameters anorexia, insomnia, and decreased mobility, high scores mean good response, for the other parameters low scores mean good response."|6 months|||units on a scale||Full Range|Median
722679|NCT00326885|Secondary|Overall Survival (OS)|Overall survival is defined as the interval from the date of first dose to the date of death.|≥ 6 months|||months||95% Confidence Interval|Median
722680|NCT00326885|Secondary|Puncture/Paracentesis-free Survival (PuFS)|Puncture/Paracentesis-free Survival (PuFS), Defined as the Number of Days Between the Date of Last Dose and the Date of Documented End of Study (EoS) Paracentesis or Death, Whichever Occurred First|≥6 months|Full analysis set (FAS) Per protocol (PP)||weeks||Full Range|Median
722681|NCT00326885|Primary|The Proportion of Patients Who Achieved at Least a 4-fold Increase of Puncture/Paracentesis-free Interval Following Catumaxomab Relative to Their Pre-treatment Interval.|The parameter to be estimated is the proportion of patients who achieve at least a 4-fold increase in their puncture/paracentesis-free interval. The pretreatment interval is defined as the length of time between the patient’s most recent paracentesis (baseline) and the subsequent paracentesis necessitated by her increasing ascites-related symptoms. The post-treatment interval is defined as the time between the last dose of catumaxomab plus 1 day to the time of recurrence of ascites requiring therapeutic paracentesis or death, whichever occurred sooner.|6 months|||proportion of patients|||Number
722682|NCT00326898|Other Pre-specified|Frequency of Clinically Significant Congestive Heart Failure (CHF) Grade 3 or Higher Using the Common Terminology Criteria for Adverse Events Version 4.0||Assessed every 6 weeks while on treatment and for 30 days after the end of treatment||||||
722683|NCT00326898|Other Pre-specified|The Association Between Scan Frequency and Development of Congestive Heart Failure||Assessed at 3, 6 and 12 months||||||
722684|NCT00326898|Other Pre-specified|Patient-reported Fatigue Using the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form|PROMIS Fatigue short form is a newly developed state-of-the-science PROMIS measure for fatigue|Assessed at baseline, 10 weeks and 22 weeks||||||
722685|NCT00326898|Other Pre-specified|Patient-reported Fatigue Using Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale||Assessed at baseline, 10 weeks and 22 weeks||||||
722686|NCT00326898|Other Pre-specified|The Effect of Vascular Endothelial Growth Factor (VEGF) Targeted Therapy on Circulating Endothelial Cells and Circulating Endothelial Progenitors||Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry||||||
722690|NCT00326898|Other Pre-specified|The Association Between Disease-free Survival and the Frequency of Oncogene as Well as Tumor Suppressor Gene Mutations||Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry||||||
722691|NCT00326898|Other Pre-specified|The Association Between Angiogenesis Markers and Disease-free Survival||Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry||||||
722692|NCT00326898|Secondary|5-year Disease-free Survival (DFS) Rate Among Patients With Clear Cell Histology|Disease-free survival (DFS) is defined as time from randomization to recurrence, development of second primary cancer (except localized breast or prostate cancer or nonmelanoma skin cancer), or death from any cause. Patients who were alive without recurrence or qualifying second primary cancer were censored at the date of last disease evaluation. 5-year DFS rate is the proportion of patients who are alive and disease-free at 5 years based on the Kaplan-Meier estimate.|Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry|Patients with clear cell histology were included in this analysis.||proportion of participants||97.5% Confidence Interval|Number
722693|NCT00326898|Secondary|Proportion of Patients With Cardiac Events|Cardiac event is defined as left ventricular ejection fraction (LVEF) below the institutional lower limit of normal, where the decrease was >15% absolute percentage points from baseline within 6 months.|Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry|Patients with at least 1 follow-up MUGA scan were included in this analysis.||Proportion of participants||90% Confidence Interval|Number
722694|NCT00326898|Secondary|5-year Overall Survival Rate|Overall survival is defined as the time from randomization to death from any cause. Patients without a date of death were censored at the date of last contact. Kaplan-Meier method was used to estimate 5-year survival rate.|Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry|All randomized patients||proportion of participants||97.5% Confidence Interval|Number
722695|NCT00326898|Primary|Disease-free Survival (DFS)|Disease-free survival (DFS) is defined as time from randomization to recurrence, development of second primary cancer (except localized breast or prostate cancer or nonmelanoma skin cancer), or death from any cause. Patients who were alive without recurrence or qualifying second primary cancer were censored at the date of last disease evaluation.|Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry|All randomized patients||years||97.5% Confidence Interval|Median
722696|NCT00326911|Secondary|Change From Baseline in Assessment of Pain Using BPI Short Form, Interference, at Cycle 2 Week 4|Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. Analysis of pain using the BPI was considered exploratory. The Interference question (change from baseline) to Cycle 2 Week 4 is reported. Complete interference is scored as 10 and no interference is scored as 0. A negative score indicates improvement from baseline.|Screening, and then every 8 weeks while receiving study drug to 30-day follow-up|mITT population||Scores on a scale||Standard Deviation|Mean
722697|NCT00326911|Secondary|Change From Baseline in Assessment of Pain Using BPI Short Form, Pain Right Now, at Cycle 2 Week 4|Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. Analysis of pain using the BPI was considered exploratory. The Pain Right Now question (change from baseline) to Cycle 2 Week 4 is reported. The worst pain is 10 and no pain is 0. A negative score indicates improvement from baseline.|Screening, and then every 8 weeks while receiving study drug to 30-day follow-up|mITT population||Scores on a scale||Standard Deviation|Mean
722698|NCT00326911|Secondary|Change From Baseline in Assessment of Pain Using BPI Short Form, Average Pain, at Cycle 2 Week 4|Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. Analysis of pain using the BPI was considered exploratory. The Average Pain (change from baseline) to Cycle 2 Week 4 is reported. The worst pain was 10 and no pain is 0. A negative score indicates improvement from baseline.|Screening, and then every 8 weeks while receiving study drug to 30-day follow-up|mITT population||Scores on a scale||Standard Deviation|Mean
722699|NCT00326911|Secondary|Change From Baseline in Assessment of Pain Using BPI Short Form, Least Pain, at Cycle 2 Week 4|Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. Analysis of pain using the BPI was considered exploratory. The Least Pain (change from baseline) to Cycle 2 Week 4 is reported. The worst pain is 10 and no pain is 0. A negative score indicates improvement from baseline.|Screening, and then every 8 weeks while receiving study drug to 30-day follow-up|mITT population||Scores on a scale||Standard Deviation|Mean
722700|NCT00326911|Secondary|Change From Baseline in Assessment of Pain Using the Brief Pain Inventory (BPI) Short Form, Worst Pain, at Cycle 2 Week 4|Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. Analysis of pain using the BPI was considered exploratory. The Worst Pain (change from baseline) to Cycle 2 Week 4 is reported. The worst pain is 10 and no pain is 0. A negative score indicates improvement from baseline.|Screening, and then every 8 weeks while receiving study drug to 30-day follow-up|mITT population||Scores on a scale||Standard Deviation|Mean
722701|NCT00326911|Secondary|Change From Baseline in QoL Assessment Using LASA, Legal Concerns, at Cycle 2 Week 4|Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Legal Concerns question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A negative score indicates worsening from baseline.|Screening, and then every 8 weeks while receiving study drug to 30-day follow-up|mITT population||Scores on a scale||Standard Deviation|Mean
722702|NCT00326911|Secondary|Change From Baseline in QoL Assessment Using LASA, Financial Concerns, at Cycle 2 Week 4|Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Financial Concerns Question question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A negative score indicates worsening from baseline.|Screening, and then every 8 weeks while receiving study drug to 30-day follow-up|mITT population||Scores on a scale||Standard Deviation|Mean
722703|NCT00326911|Secondary|Change From Baseline in QoL Assessment Using LASA, Level of Support, Friends and Family, at Cycle 2 Week 4|Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Level of Support, Friends and Family question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A negative score indicates worsening from baseline.|Screening, and then every 8 weeks while receiving study drug to 30-day follow-up|mITT Population||Scores on a scale||Standard Deviation|Mean
722704|NCT00326911|Secondary|Change From Baseline in QoL Assessment Using LASA, Level of Fatigue, Average, at Cycle 2 Week 4|Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Level of Fatigue question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A positive score indicates improvement from baseline.|Screening, and then every 8 weeks while receiving study drug to 30-day follow-up|mITT Population||Scores on a scale||Standard Deviation|Mean
722705|NCT00326911|Secondary|Change From Baseline in QoL Assessment Using LASA, Severity of Pain, Average, at Cycle 2 Week 4|Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Severity of Pain question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A positive score indicates improvement from baseline.|Screening, and then every 8 weeks while receiving study drug to 30-day follow-up while receiving study drug|mITT population||Scores on a scale||Standard Deviation|Mean
722706|NCT00326911|Secondary|Change From Baseline in QoL Assessment Using LASA, Frequency of Pain, at Cycle 2 Week 4|Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Frequency of Pain question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A negative score indicates improvement from baseline.|Screening, and then every 8 weeks while receiving study drug to 30-day follow-up|mITT population||Scores on a scale||Standard Deviation|Mean
722707|NCT00326911|Secondary|Change From Baseline in QoL Assessment Using LASA, Overall Spiritual Well Being, at Cycle 2 Week 4|Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Overall Spiritual Well Being question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A negative score indicates worsening from baseline.|Screening, and then every 8 weeks while receiving study drug to 30-day follow-up while receiving study drug|mITT population||Scores on a scale||Standard Deviation|Mean
722708|NCT00326911|Secondary|Change From Baseline in QoL Assessment Using LASA, Level of Social Activity, at Cycle 2 Week 4|Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Level of Social Activity question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A negative score indicates worsening from baseline.|Screening, and then every 8 weeks while receiving study drug to 30-day follow-up|mITT population||Scores on a scale||Standard Deviation|Mean
722709|NCT00326911|Secondary|Change From Baseline in QoL Assessment Using LASA, Overall Emotional Well Being, at Cycle 2 Week 4|Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Overall Emotional Well Being question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A negative score indicates worsening from baseline.|Screening, and then every 8 weeks while receiving study drug to 30-day follow-up|mITT Population||Scores on a scale||Standard Deviation|Mean
722710|NCT00326911|Secondary|Change From Baseline in QoL Assessment Using LASA, Overall Physical Well Being, at Cycle 2 Week 4|Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Overall Physical Well Being question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A negative score indicates worsening from baseline.|Screening, and then every 8 weeks while receiving study drug to 30-day follow-up|mITT population||Scores on a scale||Standard Deviation|Mean
722711|NCT00326911|Secondary|Change From Baseline in QoL Assessment Using LASA, Overall Mental Well Being, at Cycle 2 Week 4|Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Overall Mental Well Being question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A negative score indicates worsening from baseline.|Screening, and then every 8 weeks while receiving study drug to 30-day follow-up|mITT population||Scores on a scale||Standard Deviation|Mean
722712|NCT00326911|Secondary|Change From Baseline in Quality of Life (QoL) Assessment Using the Linear Analog Scale Assessment (LASA), Overall QoL at Cycle 2 Week 4|Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Overall QoL question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A negative score indicates worsening from baseline.|Screening, and then every 8 weeks while receiving study drug to 30-day follow-up|mITT population||Scores on a scale||Standard Deviation|Mean
722731|NCT00326963|Secondary|Number of Participants With Any Adverse Event (AE) and Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAEs are defined as those events that were fatal or immediately life-threatening, and those events that resulted in hospitalization; prolonged an existing hospitalization; resulted in disability; or was a congenital anomaly.|Up to Week 28|Analysis was performed on the Safety Population. The Safety Population included all the participants who received at least one dose of trial medication and had a safety follow-up.||participants|||Number
722713|NCT00326911|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Reported AEs per patient were coded according to the corresponding preferred term and system organ class in the Medical Dictionary for regulatory Activities dictionary. The National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 3.0 was used to grade all AEs. The collection of AEs began at the time the patient received the first cetuximab dose and continued during the study until 30 days after the last dose of cetuximab. All patients who were enrolled and treated with cetuximab were assessed for safety (mITT population, as treated).|An AE was included in the safety analysis if its onset date occurred anytime during cetuximab treatment or up to 30 days after the last dose of cetuximab.|All patients who received any quantity of study therapy were included in the safety evaluation (safety population, as treated).||Participants|||Number
722714|NCT00326911|Secondary|Time to Progression (TTP)|Time to progression was defined as the time from randomization until the date of objectively confirmed tumor progression was first reported. The censoring rule was consistent with PFS except death. Patients who died from any cause were censored at the time of death or at last tumor assessment date if the death date was missing. For patients lost to follow-up, they were censored at the last tumor assessment date.|Time from randomization until the date of objective tumor progression was first reported (range: 11 -38 months)|The TTP was based on the mITT population. For patients lost to follow-up, they were censored at the next scheduled visit.||months||95% Confidence Interval|Median
722715|NCT00326911|Secondary|Percentage of Patients With Carbohydrate Antigen 19-9 (CA19-9) Response at End of Cycle 2 in Patients With Elevated Baseline Values (Equal or Greater Than 2 x Upper Limit of Normal).|CA19-9 is a tumor marker for pancreatic cancer and the level usually increases as the disease is progressing. The CA19-9 response was the percentage of patients whose CA19-9 level was declining, stable or increasing < 10% compared with baseline, divided by the total patients with elevated baseline CA19-9 in that arm.|First day of treatment to the end of Cycle 2, Week 1|The CA19-9 response rate was calculated for at least the 15 patients in each arm of the study at the end of the first two cycles of therapy (8 weeks) in the mITT population who had elevated CA19-9 levels at baseline.||Percentage of participants|||Number
722716|NCT00326911|Secondary|The Number of Patients With a Best Overall Response of Either a Complete Response (CR) or Partial Response (PR)|The best overall response is the number of patients with a best overall response of CR or PR, as classifed by the investigator according to the RECIST guidelines. A CR is the disappearance of all target lesions and a PR is at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter.|Tumor evaluations were performed every 8 weeks while on cetuximab therapy until PD or recurrence. Patients with a PR or CR had a confirmatory tumor assessment no less than 4 weeks after the initial evaluation.|The best overall response was based on the mITT population for those patients who either had a CR or PR.||Participants|||Number
722717|NCT00326911|Secondary|Overall Survival (OS)|This measure is defined as the time from randomization to the date of death due to any cause. Survival of living patients or those who lost to follow-up were censored on the last date the patients were known to be alive.|Survival information was collected continuously every 3 months after completion of therapy and/or follow-up (range: 1-19 months).|The overall survival was based on the mITT population.||Months||95% Confidence Interval|Median
722718|NCT00326911|Primary|Progression-free Survival (PFS)|Progression-free survival is the time from randomization until the date of progressive disease (PD) or death from any cause whichever is first reported. Patients who die without a reported prior progression were considered to have progresssed on the day of their death. Patients who did not progress were censored at the day of their last tumor assessment.|Time from randomization to disease progression or death from any cause (Range: 0 -10 months)|The PFS was based on the modified Intent-to-Treat (mITT) population, which included any patient who enrolled, was randomized, and received any quantity of study drug.||months||95% Confidence Interval|Median
722719|NCT00326950|Secondary|Safety, Tolerability, the Pharmacokinetics, a Recommended Dose (RD) for Phase II Clinical Study and the Anti-tumor Effect in Evaluable Subjects.||3 weeks||||||
722720|NCT00326950|Primary|Maximum Tolerated Dose (MTD)|MTD was the lowest dose at which a dose limiting toxicity occurred.|3 Weeks|||mg/m^2|||Number
722721|NCT00326950|Primary|Number of Subjects Who Experienced Dose Limiting Toxicity (DLT)|DLT is an adverse drug reaction defined as 1)Grade 4 neutropenia for 5 days, 2)>/=Grade 3 febrile neutropenia, 3)>/=Grade 3 neutropenia requiring iv antibiotics, 4)Grade 4 thrombocytopenia, 5)>/=Grade 3 nonhematologic toxicity, 6)Omission of study drug on Day 8 due to >/=Grade 3 neutropenia or thrombocytopenia or investigator decision.|3 weeks|||participants|||Number
722722|NCT00326963|Secondary|Number of Participants Discontinuing Study Medication Due to Clinical Adverse Events|The total number and percentage of participants who discontinued the study medication (ENF) due to clinical adverse events (including clinically significant laboratory abnormalities and AIDS Clinical Trials Group (ACTG) grade≥3 laboratory toxicities) were noted and presented.|Up to Week 24|Analysis was performed on the Safety Population. The Safety Population included all the participants who received at least one dose of trial medication and had a safety follow-up.||participants|||Number
722723|NCT00326963|Secondary|Descriptive Summary of ISR Parameters (ie, Severity and Frequency of Pain and Symptoms) by Injection Device Based on an ISR Grading Tool.|Injection site reactions (ISRs) referred to any localized sign or symptom, including erythema, induration, pruritus, nodules, ecchymosis (degree of bruising/ discoloration), and pain/discomfort. Injection site reactions were monitored by trained study personnel at weeks 1, 4, 12, 16, and 24. Grades 0 through 4 are a measure of intensity, not seriousness. Thus, a grade 3 or grade 4 sign or symptom could be severe, but not necessarily serious. Only active, ongoing ISR were counted. The maximum severity grade for pain/discomfort since the last visit at any injection site was recorded whether or not the maximum severity of pain/discomfort was ongoing at the time of clinical evaluation.|Week 24|Analysis was performed on the Safety Population. The Safety Population included all the participants who received at least one dose of trial medication and had a safety follow-up. Maximum number of participants available at the particular time point were analysed and reported.||participants|||Number
722787|NCT00327717|Secondary|The Mean Percent Change From Baseline in Complex Partial (CP) Seizure Frequency|The Mean Percent Change in seizure frequency of CP from baseline during the fixed-dose phase.|Baseline and 16 weeks|FAS population. Complex partial seizure patients||Percent Change||Standard Deviation|Mean
722724|NCT00326963|Secondary|Percentage of Participants With 1 or More Injection Site Reactions Meeting the Criteria of an Serious Adverse Event|Injection site reactions (ISRs) referred to any localized sign or symptom, including erythema, induration, pruritus, nodules, ecchymosis (degree of bruising/ discoloration), and pain/discomfort. Injection site reactions were monitored by trained study personnel at weeks 1, 4, 12, 16, and 24. Interruption of ENF for toxicity management of recurrent local grade 3 or 4 ISRs until the sign or symptom resolved to grade 2 was at the discretion of the investigator. Any individual injection site signs or symptoms meeting the criteria for a serious adverse event (SAE) had to be reported as an SAE. In the event of a serious ISR, the participant was to immediately discontinue ENF and withdraw from the study. If the participant was not already hospitalized, serious ISRs required a clinic visit within 72 hours of the event.|Week 1 to Week 24|Analysis was performed on the Safety Population. The Safety Population included all the participants who received at least one dose of trial medication and had a safety follow-up.||Percentage of participants|||Number
722725|NCT00326963|Secondary|Number of Participants With 1 or More Injection Site Reactions Meeting the Criteria of an Serious Adverse Event|Injection site reactions (ISRs) referred to any localized sign or symptom, including erythema, induration, pruritus, nodules, ecchymosis (degree of bruising/ discoloration), and pain/discomfort. Injection site reactions were monitored by trained study personnel at weeks 1, 4, 12, 16, and 24. Interruption of ENF for toxicity management of recurrent local grade 3 or 4 ISRs until the sign or symptom resolved to grade 2 was at the discretion of the investigator. Any individual injection site signs or symptoms meeting the criteria for a serious adverse event (SAE) had to be reported as an SAE. In the event of a serious ISR, the participant was to immediately discontinue ENF and withdraw from the study. If the participant was not already hospitalized, serious ISRs required a clinic visit within 72 hours of the event.|Week 1 to Week 24|Analysis was performed on the Safety Population. The Safety Population included all the participants who received at least one dose of trial medication and had a safety follow-up.||participants|||Number
722726|NCT00326963|Secondary|Percentage of Participants Adhering to ENF|Adherence to ENF treatment regimen was calculated using the participant’s response to the query on the “Participant Adherence Questionnaire case report form (CRF)” about injections incomplete or missed in the last 4 days preceding the study visit. The percentage adherence to the ENF regimen at each study visit is given by: % Adherence = ([8 - the number of doses missed] / 8) x 100. The number and percentage of participants adhering to the ENF regimen were presented by adherence category (100%, ≥95%, ≥90% and ≥85%) at Weeks 4, 12, and 24.|Weeks 4, 12, and 24|Analysis was performed on the Intent-to-treat (ITT) Population. The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment. Maximum number of participants available at the particular time point were analysed and reported.||Percentage of Participants|||Number
722727|NCT00326963|Secondary|Number of Participants Adhering to Enfuvirtide (ENF)|Adherence to ENF treatment regimen was calculated using the participant’s response to the query on the “Participant Adherence Questionnaire case report form (CRF)” about injections incomplete or missed in the last 4 days preceding the study visit. The percentage adherence to the ENF regimen at each study visit is given by: % Adherence = ([8 - the number of doses missed] / 8) x 100. The number and percentage of participants adhering to the ENF regimen were presented by adherence category (100%, ≥95%, ≥90% and ≥85%) at Weeks 4, 12, and 24.|Weeks 4, 12, and 24|Analysis was performed on the Intent-to-treat (ITT) Population.The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment. Maximum number of participants available at the particular time point were analysed and reported.||participants|||Number
722728|NCT00326963|Secondary|Percentage of Participants Meeting Virologic Failure Criteria|The participant was considered as virologic failure at Week 12 clinic visit if patient achieved HIV-RNA <50 copies/mL at Week 4, and HIV-RNA > 50 copies/mL at Week 12, and HIV-RNA >50 copies/mL confirmed at 2 to 4 weeks after Week 12 or if participants failed to achieve a viral load decrease from baseline greater or equal to 0.5 log10 at Week 12 and failed to achieve a viral load decrease from baseline greater or equal to 0.5 log10 confirmed at 2 to 4 weeks after Week 12. The participant was considered as virologic failure at Week 24 clinic visit if participant achieved HIV-RNA <50 copies/mL at week 12, and HIV-RNA >50 copies/mL at week 24/early discontinuation, and HIV-RNA >50 copies/mL confirmed at 2 to 4 weeks after week 24/early discontinuation or HIV-RNA >50 copies/mL at any time up to week 24 and HIV-RNA >50 copies/mL confirmed at 2 to 4 weeks after week 24/early discontinuation.|Weeks 12 and 24|Analysis was performed on the Intent-to-treat (ITT) Population. The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment.||Percentage of participants|||Number
722729|NCT00326963|Secondary|Number of Participants Meeting Virologic Failure Criteria|The participant was considered as virologic failure at Week 12 clinic visit if patient achieved HIV-RNA <50 copies/mL at Week 4, and HIV-RNA > 50 copies/mL at Week 12, and HIV-RNA >50 copies/mL confirmed at 2 to 4 weeks after Week 12 or if participants failed to achieve a viral load decrease from baseline greater or equal to 0.5 log10 at Week 12 and failed to achieve a viral load decrease from baseline greater or equal to 0.5 log10 confirmed at 2 to 4 weeks after Week 12. The participant was considered as virologic failure at Week 24 clinic visit if participant achieved HIV-RNA <50 copies/mL at week 12, and HIV-RNA >50 copies/mL at week 24/early discontinuation, and HIV-RNA >50 copies/mL confirmed at 2 to 4 weeks after week 24/early discontinuation or HIV-RNA >50 copies/mL at any time up to week 24 and HIV-RNA >50 copies/mL confirmed at 2 to 4 weeks after week 24/early discontinuation.|Weeks 12 and 24|Analysis was performed on the Intent-to-treat (ITT) Population. The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment.||participants|||Number
722730|NCT00326963|Secondary|Change From Baseline in CD4+ Lymphocyte Count|Summary statistics for change from baseline in CD4+ lymphocyte count were presented . Change from baseline in CD4+ lymphocyte count was derived as follows: Change from baseline = (CD4+ count at Week X) – (CD4+ count at baseline).|Baseline (Day 1), Weeks 4, 12, and 24|Analysis was performed on the Intent-to-treat (ITT) Population. The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment. Maximum number of participants available at the particular time point were analysed and reported.||cells/mm^3||Standard Deviation|Mean
724352|NCT00331760|Secondary|Disease-free Survival||From registration to date of failure (any tumor recurrence, development of distant metastases or death) or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years.||||||
722732|NCT00326963|Secondary|Change From Baseline in Log 10 Plasma HIV-1 RNA Viral Load|Summary statistics for change from baseline in plasma HIV-1 RNA count were presented. Change from baseline in plasma HIV-1 RNA count was derived as follows: Change from baseline = (plasma HIV-1 RNA count at Week X) – (plasma HIV-1 RNA count at baseline).|Baseline (Day 1), Weeks 4, 12, and 24|Analysis was performed on the Intent-to-treat (ITT) Population. The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment. Maximum number of participants available at the particular time point were analysed and reported.||copies/mL||Standard Deviation|Mean
722733|NCT00326963|Secondary|Percentage of Participants With HIV-1 RNA Viral Load <400 Copies/mL|Blood samples for HIV-1 RNA viral load measurement were collected at the Week 4, Week 12, and Week 24 clinic visit. The number of participants with HIV-1 RNA Viral Load results <400 copies/mL is reported.|Weeks 4, 12, and 24|Analysis was performed on the Intent-to-treat (ITT) Population. The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment.||Percentage of participants||95% Confidence Interval|Number
722734|NCT00326963|Secondary|Number of Participants With HIV-1 RNA Viral Load <400 Copies/mL|Blood samples for HIV-1 RNA viral load measurement were collected at the Week 4, Week 12, and Week 24 clinic visit. The number of participants with HIV-1 RNA Viral Load results <400 copies/mL is reported.|Weeks 4, 12, and 24|Analysis was performed on the Intent-to-treat (ITT) Population. The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment.||participants|||Number
722735|NCT00326963|Secondary|Percentage of Participants With HIV-1 RNA Viral Load <50 Copies/mL|Blood samples for HIV-1 RNA viral load measurement were collected at the Week 4 and Week 12 clinic visit. The percentage of participants with HIV-1 RNA Viral Load results <50 copies/mL is reported.|Week 4 and 12|Analysis was performed on the Intent-to-treat (ITT) Population. The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment.||Percentage of Participants||95% Confidence Interval|Number
722736|NCT00326963|Secondary|Number of Participants With HIV-1 RNA Viral Load <50 Copies/mL|Blood samples for HIV-1 RNA viral load measurement were collected at the Week 4 and Week 12 clinic visit. The number of participants with HIV-1 RNA results <50 copies/mL is reported.|Week 4 and 12|Analysis was performed on the Intent-to-treat (ITT) Population. The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment.||participants|||Number
722737|NCT00326963|Primary|Percentage of Participants With HIV-1 RNA Viral Load <50 Copies/mL|Blood samples for HIV-1 RNA viral load measurement were collected at the Week 24 clinic visit. The percentage of participants with HIV-1 RNA results <50 copies/mL is reported.|Week 24|Analysis was performed on the Intent-to-treat (ITT) Population. The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment.||Percentage of Participants||97.5% Confidence Interval|Number
722738|NCT00326963|Primary|Number of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Viral Load <50 Copies/mL|Blood samples for HIV-1 RNA viral load measurement were collected at the Week 24 clinic visit. The number of participants with HIV-1 RNA viral load results <50 copies/mL is reported.|Week 24|Analysis was performed on the Intent-to-treat (ITT) Population. The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment.||participants|||Number
722739|NCT00327015|Secondary|Percentage of Participants Requiring Rescue or Discontinuation at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy|Percentage of participants requiring rescue for failing to achieve pre-specified glycemic targets or discontinuing for lack of efficacy within the 24-week treatment period at each dose of saxagliptin plus metformin versus metformin alone.|Week 24|Randomized participants who took at least 1 dose of double-blind treatment were included in the Week 24 LOCF analysis.||Percentage of participants|||Number
722740|NCT00327015|Secondary|Percentage of Participants Requiring Rescue or Discontinuation at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy|Percentage of participants requiring rescue for failing to achieve pre-specified glycemic targets or discontinuing for lack of efficacy within the 24-week treatment period at each dose of saxagliptin plus metformin versus saxagliptin alone.|Week 24|Randomized participants who took at least 1 dose of double-blind treatment were included in the Week 24 LOCF analysis.||Percentage of participants|||Number
722741|NCT00327015|Secondary|Percentage of Participants Achieving A1C ≤6.5% at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy|Percentage of participants achieving A1C ≤6.5%, at each dose of saxagliptin plus metformin versus metformin alone at Week 24.|Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in the Week 24 LOCF analysis, participants must have had at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.||Percentage of participants|||Number
722742|NCT00327015|Secondary|Percentage of Participants Achieving A1C ≤6.5% at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy|Percentage of participants achieving A1C ≤6.5%, at each dose of saxagliptin plus metformin versus saxagliptin alone at Week 24.|Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in the Week 24 LOCF analysis, participants must have had at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.||Percentage of Participants|||Number
722743|NCT00327015|Secondary|Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy|Mean change from baseline for 0 to 180 minutes PPG AUC at Week 24, adjsuted for baseline value.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.||mg*min/dL||Standard Error|Mean
722788|NCT00327717|Primary|Median Percent Change From Baseline in All Partial Seizure Frequency (Complex Partial Seizures (CP)+ Simple Partial Seizures (SP) + Secondary Generalization Seizures (SGS)) During the Fixed-dose Phase|The median percent change in seizure frequency of all partial seizures (CP+SP+SGS) from baseline during the fixed-dose phase.|Baseline and 16 weeks|Full analysis set (FAS)||Percent Change||Full Range|Median
722744|NCT00327015|Primary|Change From Baseline in A1C at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy|Mean change from baseline in A1C at Week 24, adjusted for baseline value.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.||percent||Standard Error|Mean
722745|NCT00327015|Secondary|Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy|Mean change from baseline for 0 to 180 minutes PPG AUC at Week 24, adjusted for baseline value.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.||mg*min/dL||Standard Error|Mean
722746|NCT00327015|Secondary|Percentage of Participants Achieving A1C < 7% at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy|Percentage of participants achieving A1C < 7%, the American Diabetes Association’s defined goal for glycemia, at each dose of saxagliptin plus metformin versus metformin alone at Week 24.|Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in the Week 24 LOCF analysis, participants must have had at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.||Percentage of participants|||Number
722747|NCT00327015|Secondary|Percentage of Participants Achieving A1C < 7% at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy|Percentage of participants achieving A1C < 7%, the American Diabetes Association’s defined goal for glycemia, at each dose of saxagliptin plus metformin versus saxagliptin alone at Week 24.|Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in the Week 24 LOCF analysis, participants must have had at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.||Percentage of participants|||Number
722748|NCT00327015|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy|Mean change from baseline in FPG at Week 24, adjusted for baseline value.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.||mg/dL||Standard Error|Mean
722749|NCT00327015|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy|Mean change from baseline in FPG at Week 24, adjusted for baseline value.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.||mg/dL||Standard Error|Mean
722750|NCT00327015|Primary|Change From Baseline in Hemoglobin A1c (A1C) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy|Mean change from baseline in A1C at Week 24, adjusted for baseline value.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 Last Observation Carried Forward (LOCF), subjects must have had a baseline and at least 1 post-baseline measurement. If participant received rescue medication, that measurement must have been taken before rescue.||percent||Standard Error|Mean
722751|NCT00327171|Secondary|Participant's Assessment of Health Related Quality of Life (HRQL) Using a by Using the Functional Assessment of Cancer Therapy-Ovarian (FACT-O) Questionnaire|The FACT-O questionnaire consists of 38 scored questions (scored from 0-4) that address physical well-being, social/family well-being, emotional well-being, functional well-being and some additional concerns which relate specifically to ovarian cancer symptoms. For each question, higher scores reflect a better quality of life. The total FACT-O score ranges from 0-152, with 152 indicating the best outcome.|On Day 1 of Cycle 1 (baseline) , and after Day 14 of Cycle 2|All randomized participants who had evaluable FACT-O questionnaires.||score on a scale||Standard Deviation|Mean
722752|NCT00327171|Secondary|Overall Safety - Number of Participants With Adverse Events (AE)|All AEs regardless of seriousness or relationship to study treatment, spanning from the first administration of study treatment until 30 days after the last administration of study treatment, were recorded, and followed until resolution or stabilization. The number of participants with all treatment emergent adverse events (TEAE), serious adverse events (SAE), TEAE leading to death, and TEAE leading to permanent treatment discontinuation are reported.|up to 30+/-5 days after treatment discontinuation, or up to recovery or stabilization of a followed-up adverse event|Safety population: All randomized participants who received at least part of one dose of study treatment.||participants|||Number
722753|NCT00327171|Primary|Number of Participants With Confirmed Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Based on the Analysis by the IRC - Efficacy Evaluable Population|"OR included Complete Response (CR) and Partial Response (PR). Per RECIST, CR was disappearance of all target or non-target lesions, or normalization of tumor marker levels (for non-target lesions) and PR was at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, with baseline sum LD as reference.
Tumors were assessed by an independent third-party core imaging laboratory evaluating the chest, abdomen, and pelvis by Computerized Tomography (CT) scans or Magnetic Resonance Imaging (MRI) scans; and responses were confirmed by repeat tumor imaging 4-6 weeks later."|From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months)|Efficacy evaluable population: All participants with advanced ovarian epithelial carcinoma who were randomized, underwent baseline tumor assessment, and received at least part of one dose of aflibercept.||participants|||Number
722771|NCT00327444|Primary|Time to Repeat Paracentesis (TRP)|"TRP was defined as the number of days between the date of randomization and the date of the first post-randomization paracentesis.
For participants who did not undergo a postrandomization paracentesis on study, TRP was calculated from randomization to the end of the double-blind treatment period."|From Day 1 up to 6 months from randomization|The intent-to-treat (ITT) population - all participants who were randomized in the study.||days||Standard Error|Least Squares Mean
722754|NCT00327171|Secondary|Overall Survival (OS) Time|"OS was the time interval between randomization and the date of death from any cause. OS was estimated using Kaplan-Meier curves
A participant was censored for the OS analysis if the participant were alive during the study. The censoring date was either at the date that the participant was last known to be alive or the date of study cut-off, whichever was earlier."|From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months)|Efficacy evaluable population: All participants with advanced ovarian epithelial carcinoma who were randomized, underwent baseline tumor assessment, and received at least part of one dose of aflibercept.||weeks|Participants|95% Confidence Interval|Median
722755|NCT00327171|Secondary|Progression-free Survival (PFS) Time Based on Analysis by the IRC|"PFS was as the time interval measured from the date of randomization to the date of tumor progression as determined by RECIST or death from any cause, whichever was earlier. PFS was estimated using Kaplan-Meier curves.
For a participant who did not reach tumor progression during study, the censoring date was the date of the last valid tumor burden assessment or the date of study cut-off, whichever was earlier. If the participant had no valid post-baseline tumor burden assessment due to early termination, the censoring date was the date of randomization."|From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months)|Efficacy evaluable population: All participants with advanced ovarian epithelial carcinoma who were randomized, underwent baseline tumor assessment, and received at least part of one dose of aflibercept.||weeks|Participants|95% Confidence Interval|Median
722756|NCT00327171|Secondary|Number of Participants With Disease Progression Events for Progression-free Survival (PFS) Analysis by the IRC.|"PFS was as the time interval measured from the date of randomization to the date of tumor progression as determined by RECIST or death from any cause, whichever was earlier.
The number of participants with tumor/disease progression are reported. Participants who did not reach tumor progression during study, or had no valid post-baseline tumor burden assessment due to early termination, were censored in the PFS analysis."|From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months)|Efficacy evaluable population: All participants with advanced ovarian epithelial carcinoma who were randomized, underwent baseline tumor assessment, and received at least part of one dose of aflibercept.||participants|||Number
722757|NCT00327171|Secondary|Time to Tumor Marker (CA-125) Progression (TTMP)|"TTMP was the time interval from the date of randomization to the date of tumor marker progression as was defined by GCIG for the evaluable participants. TTMP was estimated using Kaplan-Meier curves.
For a participant who did not reach tumor marker progression (TMP) during study, the censoring date was the date of the last valid tumor burden assessment or the date of study cut-off, whichever was earlier. If the participant had no valid post-baseline tumor burden assessment due to early termination, the censoring date was the date of randomization."|From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months)|Participants with a valid assessment of CA-125 (requiring at least one pretreatment sample and 2 post-treatment samples).||weeks|Participants|95% Confidence Interval|Median
722758|NCT00327171|Secondary|Time to Tumor Progression (TTP) as Per RECIST Based on the Analysis by the IRC|"TTP was defined as the time interval measured from the date of randomization to the date of tumor progression as determined by RECIST. TTP was estimated from Kaplan-Meier curves.
For a participant who did not reach tumor progression during study, the censoring date was the date of the last valid tumor burden assessment or the date of study cut-off, whichever was earlier. If the participant had no valid post-baseline tumor burden assessment due to early termination, the censoring date was the date of randomization."|From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months)|Efficacy evaluable population: All participants with advanced ovarian epithelial carcinoma who were randomized, underwent baseline tumor assessment, and received at least part of one dose of aflibercept.||weeks|Participants|95% Confidence Interval|Median
722759|NCT00327171|Secondary|Tumor Marker Response Rate (TMRR) Based on the Gynecologic Cancer Intergroup (GCIG) Definition|TMRR was the proportion of evaluable participants achieving a cancer antigen -125 (CA-125) response based on GCIG definition. A response to CA-125 occurred if after two elevated levels before therapy there was at least a 50% decrease in a post-treatment serum sample, which was confirmed by an independent sample collected 21 days or later that was =< 110% of the post-treatment serum sample.|From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months)|Randomized participants who received at least part of one dose of aflibercept, had a baseline tumor assessment, had a valid CA-125 assessment (requiring at least two pretreatment sample and 2 post-treatment samples), did not receive mouse antibodies and had no medical or surgical interference with their peritoneum or pleura in the previous 28 days.||percentage of participants||95% Confidence Interval|Mean
722760|NCT00327171|Secondary|Duration of Response (DR) Based on the Analysis by an Independent Review Committee (IRC)|"DR was defined as the time interval from the first documentation of CR or PR to the date of tumor progression (or disease progression) as determined by RECIST, or death from any cause, whichever was earlier.
Based on RECIST, progressive disease was at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, the appearance of one or more new target or non-target lesions, or the unequivocal progression of existing non-target lesions."|From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months)|Efficacy evaluable population: All participants with advanced ovarian epithelial carcinoma who were randomized, underwent baseline tumor assessment, and received at least part of one dose of aflibercept.||days||Standard Deviation|Mean
722761|NCT00327171|Secondary|Number of Participants With a Clinical Benefit Response (CBR) as Per RECIST Based on the Analysis by the IRC|"CBR was defined as having a Stable disease (SD) for >= 6 months or a confirmed OR (PR or CR). Based on RECIST:
SD was neither a sufficient shrinkage of the target lesions to qualify for PR nor sufficient increase to qualify for Progressive disease (PD), the persistence of non-target lesions or the maintenance of tumor marker level above the normal limits (for non-target lesions)
CR was the disappearance of all target or non-target lesions; and PR was at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, with reference to the baseline sum LD."|From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months)|Simon's cohort: The first 67 evaluable participants, based on Simon’s two-stage design that required 67 evaluable participants per group to maintain a targeted 80% power for Objective response rate versus historical controls.||participants|||Number
722785|NCT00327717|Secondary|The Mean Percent Change From Baseline in Partial Seizures With Secondary Generalization (SGS)|The mean percent change in seizure frequency of SGS from baseline during the fixed-dose phase.|Baseline and 16 weeks|FAS Population. Secondary generalization patients||Percent Change||Standard Deviation|Mean
722762|NCT00327171|Primary|Number of Participants With Confirmed Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Based on the Analysis by an Independent Review Committee (IRC) - Simon's Cohort|"OR included Complete Response (CR) and Partial Response (PR). Per RECIST, CR was disappearance of all target or non-target lesions, or normalization of tumor marker levels (for non-target lesions) and PR was at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, with baseline sum LD as reference.
Tumors were assessed by an independent third-party core imaging laboratory evaluating the chest, abdomen, and pelvis by Computerized Tomography (CT) scans or Magnetic Resonance Imaging (MRI) scans; and responses were confirmed by repeat tumor imaging 4-6 weeks later."|From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months)|Simon's cohort: The first 67 evaluable participants, based on Simon’s two-stage design that required 67 evaluable participants per group to maintain a targeted 80% power for Objective response rate versus historical controls.||participants|||Number
722763|NCT00327340|Secondary|Relationship Between Changes in Serum Clusterin Levels and Change in Serum PSA Levels When OGX-011 in Combination With Either Docetaxel/Prednisone or Mitoxantrone/Prednisone is Administered as Second Line Chemotherapy.|Serum clusterin samples were collected prior to receiving OGX-011 loading dose 1, prior to study treatment on Day 1 of each cycle, and at the end of treatment. PSA was evaluated at screening, on Day 1 of each cycle, at the end of treatment visit, and during off-treatment follow-up. PSA response was defined in the protocol as a decrease in PSA of ≥ 50% relative to baseline on two or more consecutive measurements 4-6 weeks apart.|Enrollment until disease progression (up to 13 months)|All 69 subjects were included. Data are presented for the 20 subjects who achieved a 50% decline in PSA (6 subjects who received mitoxantrone and prednisone in combination with OGX-011 and 14 subjects who received docetaxel and prednisone in combination with OGX-011)||percentage of participants|||Number
722764|NCT00327340|Secondary|Feasibility of Treatment With OGX-011 in Combination With Either Docetaxel/Prednisone or Mitoxantrone/Prednisone as Second Line Chemotherapy Based on Time to Pain Progression|Time to pain progression was defined as the time (months) from the first dose of OGX-011 to the first documentation of pain or analgesic progression or initiation of palliative radiation therapy. Pain response was defined as either a decrease of at least two points on the 11-point Worst Pain Scale, without an increase in analgesic level, maintained for at least two consecutive measurements approximately three weeks apart –or– a decrease in analgesic level, without an increase in pain score, maintained for at least two consecutive measurements approximately three weeks apart.|Enrollment until pain progression (up to 21 months)|Subjects were evaluable for pain response if they had a baseline Worst Pain Score ≥ 2 or were on opioid analgesics at baseline.||months||95% Confidence Interval|Number
722765|NCT00327340|Secondary|Feasibility of Treatment With Custirsen (OGX-011) in Combination With Second-line Chemotherapy Based on Prostate Specific Antigen (PSA) Response|PSA or prostate specific antigen is a marker for prostate cancer. A PSA response was defined as a decrease in PSA values of ≥ 50% relative to baseline on two or more consecutive measurements that were 4-6 weeks apart.|PSA was evaluated at screening, on Day 1 of each cycle, at the end of treatment visit and during off-treatment follow up (up to 27 months)|"Subjects were evaluable for PSA response if they had baseline PSA and at least two post baseline PSA values.
One subject was not evaluable for PSA response; he had only one post baseline PSA value. A PSA response was defined in the protocol as a decrease in PSA of ≥ 50% relative to baseline on two or more consecutive measurements 4-6 weeks apart."||percentage of participants||95% Confidence Interval|Number
722766|NCT00327340|Primary|Safety and Tolerability of Custirsen (OGX-011) in Combination With Either Docetaxel/Prednisone or Mitoxantrone/Prednisone as Second-line Chemotherapy.|"Safety and tolerability were based on Adverse Events (AE) and Serious Adverse Events (SAE) graded using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE).
The CTCAE has 5 grades with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1=Mild AE; Grade 2=Moderate AE; Grade 3=Severe AE; Grade 4=Life-threatening or disabling AE; and Grade 5=Death related to AE."|Subjects were followed for safety from enrollment for up to 8 months (9 three-week cycles plus 30 days after end of treatment)|The total analysis population was 69 subjects: 70 subjects were enrolled; 45 were randomly assigned to treatment (24 to OGX-011/mitoxantrone and 21 to OGX-011 /docetaxel). An additional 25 subjects were assigned to OGX-011/docetaxel. One subject in the mitoxantrone arm was ineligible and did not receive study treatment.||percentage of participants|||Number
722767|NCT00327392|Primary|Incidence of Airway Assistance in Patients Undergoing Minor Surgical Procedures||2 hours|Number of patients requiring specified types of airway assistance||particpants|||Number
722768|NCT00327444|Secondary|Plasma Levels of Free and VEGF-bound Aflibercept|"Free aflibercept and VEGF-bound aflibercept plasma concentrations were measured by separate enzyme-linked immunosorbent assay (ELISA). The limit of quantitation of free aflibercept was 15.6 ng/mL, and of VEGF-bound aflibercept was 43.9 ng/mL.
Peak free aflibercept was estimated at the end of Cycle 1 (C1) administration. The median free and VEGF-bound trough concentrations were determined for each participant beyond Cycle 3 (C3), then mean values were estimated from these median values."|Following every biweekly treatment administration up to 60 days after treatment discontinuation|The analysis was performed using the safety population with evaluable blood samples. 42 participants were evaluated.||μg/mL||Standard Deviation|Mean
722769|NCT00327444|Secondary|60-Day Frequency of Paracentesis (FOP)|60-Day FOP was defined as the total number of paracenteses performed within the first 60 days after randomization during the double blind treatment period.|From Day 1 up to 60 days from randomization|The intent-to-treat (ITT) population - all participants who were randomized in the study.||paracentesis||Standard Error|Least Squares Mean
722770|NCT00327444|Secondary|Area Under the Curve (AUC) for Participant Assessed Ascites Impact Measure (AIM)|"AIM 4 symptoms (abdominal discomfort, abdominal bloating, abdominal pain, and ability to move normally) are scored from 0 to 5, where higher scores represent worst outcomes. An AIM total score ranges from 0-20.
A plot for (The AIM questionnaire total score - Baseline score) versus time were generated. AIM AUC represents the overall improvement (scored positive) if the area is below the baseline value or worsening (scored negative) if the area is above the baseline. AIM AUC for a participant is the sum of individual areas representing improvement (+) or worsening (-)."|From Day 1 up to 60 days from randomization to the first postrandomization paracentesis|The intent-to-treat (ITT) population - all participants who were randomized in the study, and had evaluable AIM scores.||(units on a 4-symptom scale)*day||Standard Error|Least Squares Mean
722772|NCT00327470|Secondary|Mean Change in Euro QoL Questionnaire (EQ-5D) Score|The EQ-5D is a validated, standardized QoL instrument assessing general health status based on the preference of a UK general population. It consists of two sections: a 100-point visual analog scale (VAS) and a descriptive system that contains five attributes (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression) with three levels per attribute (“no problem”, “some problems” and “extreme problems”). A subject’s responses to these domains were mapped to a corresponding score of the EQ-5D index.|Baseline through Week 54, Baseline through Week 102, and Week 54 through Week 102|MITT. Note: the number of participants analyzed refers to the number of subjects who had data that could be analyzed. n=number of subjects with evaluable data.||Scores on a scale||Standard Deviation|Mean
722773|NCT00327470|Secondary|Mean Change in National Eye Institute – Visual Functioning Questionnaire (NEI-VFQ-25) Composite Score|Subject reported vision-related functioning and Quality of Life (QoL) as measured using the 25 item NEI-VFQ-25. Items are grouped as the following - Composite: mean score items 1-25; General Health: item 1; General Vision: item 2; Ocular Pain: 4,19; Near Vision: 5,6,7; Distance Vision: 8,9,14; Social Functioning: 11,13; Mental Health Activities: 3,21,22,25; Role Difficulties: 17,18; Dependency: 20,23,24; Driving: 15c,16, 16a; Color Vision: 12; Peripheral Vision: 10. A positive change represents an increase in function/health, a negative change represents a decrease in function/health.|Baseline through Week 54, Baseline through Week 102, and Week 54 through Week 102|MITT. Note: the number of participants analyzed refers to the number of subjects who had data that could be analyzed. n=number of subjects with evaluable data.||Scores on a scale||Standard Deviation|Mean
722774|NCT00327470|Secondary|Mean Change From Baseline in Contrast Sensitivity|Contrast sensitivity was measured using the Pelli-Robson chart at 1 meter. Subjects were tested for contrast sensitivity using +0.50 addition over the protocol refraction providing the best-corrected distance VA. Contrast sensitivity was recorded as the log of the faintest triplet for which 2 of the 3 letters were read correctly.|Baseline through Week 54, Baseline through Week 102|MITT LOCF; Note: the number of participants analyzed refers to the number of subjects who had data that could be analyzed. n=number of subjects with evaluable data.||Correctly read letters||Standard Deviation|Mean
722775|NCT00327470|Secondary|Mean Change in Reading Speed|For assessment of reading speed, subjects were asked to read a print steadily, without stopping or interruption, at a comfortable pace. On commencing reading, a timer was activated. The timer was stopped when the subject had finished reading all of the words on the chart or at 2 minutes, whichever was sooner. Only the total number of words read correctly was recorded. The time recorded for the reading speed test was the time required for the subject to finish reading all of the words on the chart in minutes and seconds (maximum 2 minutes).|Baseline through Week 54, Baseline through Week 102, and Week 54 through Week 102|MITT LOCF; Note: the number of participants analyzed refers to the number of subjects who had data that could be analyzed. n=number of subjects with evaluable data.||Correctly read words per minute||Standard Deviation|Mean
722776|NCT00327470|Secondary|Mean Change From Baseline in Near VA in Subjects With Early and Established CNV Lesions|Near VA was measured with the modified Bailey-Lovie near-word reading charts at a distance of 25 centimeters using a +3.50 reading addition worn over the protocol refraction providing the best-corrected distance VA. The reading charts test the smallest word size identifiable from 0.0 logarithmic of the minimum angle of resolution (logMAR) to 1.6 logMAR. logMAR is the logarithm of the minimum angle of resolution. The ideal is 0.0 and represents 20/20 Snellen acuity. logMAR values >0.00 indicate vision poorer than ideal and values <0.0 indicate vision greater than ideal.|Baseline through Week 54, Baseline through Week 102|MITT LOCF. Note: the number of participants analyzed refers to the number of subjects who had data that could be analyzed. n=number of subjects with evaluable data.||Scores on a scale||Standard Deviation|Mean
722777|NCT00327470|Secondary|Mean Change From Baseline in Distance VA in Subjects With Early and Established CNV Lesions|The investigator assessed the best-corrected VA obtained by a protocol refraction using the retroilluminated modified Ferris-Bailey ETDRS charts recorded at a 2-meter distance from the chart. Distance VA was expressed as an ETDRS score (number of letters correctly read): the proportion of subjects losing >=30 letters or <15 letters, gaining >=0 or >=15 letters. The mean changes in VA from Baseline/Week 102 and Week 52/102 were assessed.|Baseline through Week 102, Week 54 through Week 102|MITT LOCF; Note: the number of participants analyzed refers to the number of subjects who had data that could be analyzed.||Scores on a scale||Standard Deviation|Mean
722778|NCT00327470|Primary|Mean Change From Baseline Through Week 54 in Distance Visual Acuity (VA) in Subjects With Early and Established CNV Lesions|The investigator assessed the best-corrected VA obtained by a protocol refraction using the retroilluminated modified Ferris-Bailey Early Treatment of Diabetic Retinopathy Study (ETDRS) charts recorded at a 2-meter distance from the chart. Distance VA was expressed as an ETDRS score (number of letters correctly read): the proportion of subjects losing >=30 letters or <15 letters from Baseline, gaining >=0 or >=15 letters from Baseline. The mean change in VA from Baseline at Week 54 was assessed.|Baseline through Week 54|The modified intent-to-treat (MITT) population included all subjects in the safety population who had a Baseline distance VA measurement and at least 1 post-Baseline VA measurement. Last observation carried forward (LOCF). Note: the number of participants analyzed refers to the number of subjects who had data that could be analyzed.||Scores on a scale||Standard Deviation|Mean
722779|NCT00327717|Secondary|Drop - Out Rate|Number of Participants who dropped out of the study. In the Study drop-out rate is defined as number of participants.|16 weeks|FAS Population||Number of Participants|||Number
722780|NCT00327717|Secondary|Percentage of Seizure-free Participants During Fixed-dose Phase|Percentage of seizure-free participants during fixed-dose phase|16 weeks|FAS Population||Percentage of Participants|||Number
722781|NCT00327717|Secondary|Mean Time to First Seizure (Days)|Mean time to first seizure during fixed dose phase|16 weeks|FAS Population||Days||Standard Deviation|Mean
722782|NCT00327717|Secondary|Mean Percentage of Change in Seizure Free Days||16 weeks|FAS Population||Percent Change||Standard Deviation|Mean
722783|NCT00327717|Secondary|Mean Number of Seizure Free Days|Mean number of seizure free days per 28 day period during fixed dose phase|12 weeks|FAS Population||Days||Standard Deviation|Mean
722784|NCT00327717|Secondary|Responder Rate|Responder rate is defined as percentage of participants with >=50% reduction in seizure frequency from baseline.|Baseline and 16 weeks|FAS Population||Percentage of Participants|||Number
724353|NCT00331760|Secondary|Distant Metastases||From registration to date of distant failure or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years.||||||
722789|NCT00313846|Secondary|"Daily Maximum Pain Right Now Score for the Primary Osteoarthritis (OA) Pain Site"|The daily maximum ‘pain right now’ score for the primary OA pain site was calculated over the last 7-day dosing period in the double-blind phase or the last 7-day dosing period prior to emergence of inadequate analgesia or discontinuation from the double-blind phase. Collected prior to ingestion of acetaminophen. “Pain right now” scale score for primary OA site on a scale from 0-10 (where 0= no pain and 10= worst pain you can imagine).|7 days of the last dosing period of the double-blind phase, or the last 7-day dosing period prior to emergence of inadequate analgesia or discontinuation from the double-blind phase.|Full Analysis Population (N = 326) consisted of subjects who were randomized and received at least 1 dose of double-blind study drug and had at least 1 primary efficacy observation during the double-blind phase.||units on a scale||Standard Error|Mean
722790|NCT00313846|Primary|The Time (Days) From First Administration of Double-blind Treatment to the Development of Inadequate Analgesia at the Primary Osteoarthritis Pain Site.|"Inadequate analgesia:
“average pain over the last 24 hours” score for pain at primary osteoarthritis (OA) site ≥ 5 on any 2 days of any 7-day dosing period, on a scale from 0 - 10 (0 = no pain to 10 = pain as bad as you can imagine)or;
>1000 mg/day acetaminophen for pain at primary OA site for ≥ 2 days in any 7-day dosing period, or;
ingested nonstudy opioid analgesic medication for pain at primary OA site. Score: lowest score = shortest time to inadequate analgesia; highest score = longest time to inadequate analgesia."|"Double-blind phase ( 28 days): reaching inadequate analgesia on any 2 days of the 7-day dosing periods"|The Full Analysis Population (N = 326) consisted of subjects who were randomized and received at least 1 dose of double-blind study drug and had at least 1 primary efficacy observation during the double-blind phase.||days||Standard Error|Mean
722791|NCT00313911|Secondary|Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination|"Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability.
Severe solicited reactions were defined as follows: Pain, cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, ≥5 cm; Fever ≥39.6 ºC; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying, >3 hours; Somnolence, sleeping most of the time or difficulty to wake up; Anorexia, refuses ≥3 feeds or refuses most feeds; Irritability, inconsolable."|Day 0 up to Day 7 Post-injection|Solicited injection site and systemic reactions were assessed in the enrolled and vaccinated participants, intent-to-treat (safety) population. Total numbers of participants (N) in each group adjusted for the participant that got a vaccine assigned for the other group.||Participants|||Number
722792|NCT00313911|Secondary|Percentage of Participants Reaching Seroprotection Threshold Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine + Placebo or Tritanrix-Hep B/Hib™ + Placebo|"Anti hepatitis B (Hep B) antibodies were measured by automated enhanced chemiluminescence assay.
Two Seroprotection thresholds were defined: a titer ≥ 10 mIU/mL and ≥ 100 mIU/mL, respectively."|Day 30 post-dose 3|Anti-hepatitis B antibody titers were assessed in a subset of the enrolled and vaccinated participants, intent-to-treat population.||Percentage of Participants|||Number
722793|NCT00313911|Secondary|Geometric Mean Titers of Anti Hepatitis B Antibodies Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine + Placebo or Tritanrix-Hep B/Hib™ + Placebo|Anti-hepatitis B (Hep B) antibodies were measured by automated enhanced chemiluminescence assay.|Day 30 post-dose 3|Anti-hepatitis B antibody titers were assessed in a subset of the enrolled and vaccinated participants, intent-to-treat population.||Titers||95% Confidence Interval|Geometric Mean
722794|NCT00313911|Primary|Number of Participants With High Fever Observed After Either DTaP-IPV-Hep B-PRP~T or Tritanrix Hep B/Hib™ + Placebo or Tritanrix-Hep B/Hib™ + Placebo Injection.|High fever was defined as rectal temperature equivalent to ≥ 39.6ºC.|Day 0 up to Day 7 post-injection|The occurrence of high fever was assessed for all enrolled and vaccinated participants, intent-to-treat (safety) population. Total numbers of participants in each group adjusted for the participant that got a vaccine assigned for the other group.||Participants|||Number
722795|NCT00314106|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|33 months|||Participants|||Number
722796|NCT00314106|Primary|Complete Response|"Determine if the combination of high dose aldesleukin, reinfused cells after lymphocyte depleting chemotherapy and 1200 cGy total body irradiation (TBI) is able to be associated with a modest fraction of patients with metastatic melanoma who can experience a complete response to therapy.
Complete response (CR) is a disappearance of all target lesions."|33 months|||Participants|||Number
722797|NCT00314132|Primary|Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo|"Treatment emergent local adverse reactions: Injection Site Pain, Itching, Erythema, Swelling, Induration, Skin Rash, and others as reported.
Treatment emergent systemic reactions: Malaise, Headache, Myalgia, Feeling Hot, Chills, Fatigue, Dyspnea, Wheezing, Nausea, Vomiting, Diarrhea, Abdominal Pain and others as reported."|Day 0 up to 30 days post-vaccination|Treatment emergent local adverse reactions and systemic reactions were assessed in all participants who received an injection of study treatment, according to the treatment they received (Safety Population).||Participants|||Number
722798|NCT00314132|Primary|Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo|"Adverse events were collected by means of diary cards and scripted interviews. All adverse events reporting was considered actively solicited through Day 30."|Day 0 up to 30 days post-vaccination|Treatment related adverse events were assessed in all participants who received an injection of study treatment, according to the treatment they received (Safety Population).||Participants|||Number
722799|NCT00314145|Primary|Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax®|"Treatment emergent local adverse events: Pain, Erythema, Pruritus, Swelling, Induration, and others as reported.
Treatment emergent systemic reactions: Fatigue, Malaise, Chills, Pyrexia, Headache, Myalgia, Arthralgia, Diarrhea, Nausea, Vomiting, and Rash."|Day 0 (Pre-vaccination) up to 60 days post-first vaccination|Treatment emergent local adverse events and systemic reactions were assessed in all subjects who had at least one injection (ChimeriVax™-JE, JE-Vax®, or placebo), according to the treatment actually received (Safety Population).||Participants|||Number
722800|NCT00314145|Secondary|Number of Participants in the Japanese Encephalitis (Homologous Virus) Neutralizing Antibody Titer Categories on Day 60 Following Either ChimeriVax™-JE or JE-Vax® Vaccination|Antibodies to Japanese encephalitis (JE) were measured by 50% plaque reduction neutralization test (PRNT50).|Day 60 post-first vaccination|Antibody titers were assessed in all participants who were seronegative to JE (both Nakayama and ChimeriVax™-JE strains) at baseline and had no protocol violations that would have interfered with evaluation of primary outcomes (Efficacy Population).||Participants|||Number
722801|NCT00314145|Secondary|Neutralizing Antibody Geometric Mean Titers (GMTs) to Japanese Encephalitis (Homologous Virus) Following Either ChimeriVax™-JE or JE-Vax® Vaccination|Antibodies to Japanese encephalitis (JE) were measured by 50% plaque reduction neutralization test (PRNT50).|Up to Day 60 post-first vaccination|Geometric mean titers were assessed in all participants who were seronegative to JE (both Nakayama and ChimeriVax™-JE strains) at baseline and had no protocol violations that would have interfered with evaluation of primary outcomes (Efficacy Population).||Titers||95% Confidence Interval|Geometric Mean
722802|NCT00314145|Primary|Number of Participants With Japanese Encephalitis (Homologous Virus) Seroconversion Following Either ChimeriVax™-JE or JE-Vax® Vaccination|Antibodies to Japanese encephalitis (JE) were measured by 50% plaque reduction neutralization test (PRNT50). Seroconversion was defined as a titer of ≥ 1:10.|Up to Day 60 post-first vaccination|Seroconversion was assessed in all participants who were seronegative to JE (both Nakayama and ChimeriVax™-JE strains) at baseline and had no protocol violations that would have interfered with evaluation of primary outcomes (Efficacy Population).||Participants|||Number
722803|NCT00314236|Secondary|Frequency of Adverse Events Between Study Groups||12 months|AEs will be coded and tabulated separately by system organ class (SOC) and individual preferred terms (PTs). The number and percentage of subjects who experienced AEs will be summarized in decreasing frequency by using the medical dictionary for regulatory activities (MedDRA) dictionary.||Percentage of participants|||Number
722804|NCT00314236|Secondary|Change From Baseline for Knee-related Pain, Stiffness and Function at 12 Months (WOMAC Parts A, B, C)|The three sub-scales: 1) Pain, 2.) stiffness and 3.) function scores ranged from 0-10. Pain had 5 items and stiffness had 2 items, and function had 17 items. The total score for pain ranged from 0 no pain to 50 worst pain. The total score for stiffness ranged from 0 no stiffness to 20 worst stiffness. The total score for function raged from 0 no function to 170 worst function.|12 months|Secondary efficacy was evaluated based on pain, stiffness, and function, as well as the macroscopic nature of the cartilage repair. Measurements of pain, stiffness, and function were made at 3, 6, and 12 months post-treatment using the WOMAC questionnaire and SF-36v2. WORMS scoring was conducted on 12-month post-treatment MRI scans.||Units on a scale||Standard Error|Least Squares Mean
722805|NCT00314236|Primary|Repair Cartilage T2 Relaxation Time|Evaluate the efficacy of BST-CarGel® applied to a microfractured lesion as compared to microfracture alone on the repair tissue quality of the study knee in subjects with symptomatic pain associated with cartilage damage using MRI T2 mapping. T2 maps are created by calculating the T2 relaxation times for repair tissue and cartilage plates for every voxel (picture element of a MRI scan containing the average signal information of a specific spatial location of the imaged body).|12 months|Sample size for repair tissue quality was calculated, using a standard t test, with an anticipated relevant difference of 15% between treatments and a common SD of 10. Under these assumptions, the sample size per group was calculated to be 11 subjects (or 22 subjects in total)||milliseconds||Standard Error|Least Squares Mean
722806|NCT00314236|Primary|Degree of Filling of the Lesion by Repair Tissue at 12 Months Through MRI.|Evaluate the efficacy of BST-CarGel® applied to a microfractured lesion as compared to microfracture alone on the degree of lesion filling of the study knee in subjects with symptomatic pain associated with cartilage damage using MRI scans. The MR images will be acquired using high resolution 3D cartilage imaging sequences, so-called cartilage morphology sequences.|12 months|Sample size for degree of lesion filling was calculated using a standard t test, with an anticipated relevant difference of 15% between treatments and a common SD of 15. Under these assumptions, the sample size per group was calculated to be 23 subjects (or 46 subjects in total)||Percentage of lesion fill||Standard Error|Least Squares Mean
722807|NCT00314249|Secondary|Time-Weighted Average of the Short Form-36 Physical Component Summary (SF-36 PCS) Score From Visit TX0-TX12|"Short Form-36 (SF-36): pt. questionnaire (36 questions) which give rise to 8 domains & 2 component summaries (mental and physical); assessing quality of life, health & functional status.
SF-36 PCS: weighted summary of physical function using all 8 domains.
Scores are standardized so that the range for all domains and component summaries is 0 (worst possible score) to 100 (best possible score). Higher scores indicate better health or functional status.
SF-36 PCS AUC (Area under the Curve): estimated using trapezoidal method, normalized by time."|Weeks 1-12 (Visit TX0-TX12) of the stable dose treatment phase|The analysis was performed based on intent-to-treat population defined as all randomized patients who took at least one dose of double-blind study medication. For all subjects with missing assessments from weeks 1-12 (Visit TX0-TX12) of the stable dose treatment phase, values were imputed using the Last Observation Carried Forward (LOCF) approach.||units on scale||Standard Error|Mean
722808|NCT00314249|Primary|Composite Pain Responder Status|"Composite Pain Responder Status is the number of responders based on two domains: (1) 30% reduction in pain (as recorded in the Patient Experience Diary [PED], electronic diary, during the morning report; 24 hour recall); and (2) Patient Global Impression of Change (PGIC) score of very much improved or much improved."|At the end of three-month stable dose treatment phase|The primary efficacy analysis was performed based on intent-to-treat population defined as all randomized patients who took at least one dose of double-blind study medication. All subjects with missing assessments at the end of three-month stable dose treatment phase were considered non-responders (baseline value carried forward (BOCF)).||Pain Responder Participants|||Number
722832|NCT00314366|Secondary|Left Ventricular End-Diastolic Volume (LVEDV)|Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Left Ventricular End-Diastolic Volume (LVEDV)which is the volume of blood inside the left ventricle when the heart has completed its filling cycle. The volume of the left ventricle is measured during contraction and relaxation. Normal heart volume inside the left ventricle is about 140 milliliters.|baseline and 6 months|||ml||Standard Deviation|Mean
722860|NCT00319735|Secondary|Evaluate Toxicity|To evaluate the overall toxicities of preoperative radiation and cetuximab in patients with esophageal and GE junction carcinomas|36 months|Grade 3 toxicities occurring in >5% of participants are reported. Safety data is presented in totality in the adverse events section.||participants|||Number
722809|NCT00314249|Primary|Composite Syndrome Responder Status|"Composite Syndrome Responder Status is the number of responders based on 3 domains: (1) 30% reduction in pain (as recorded in the Patient Experience Diary [PED], electronic diary, during the morning report; 24 hour recall); (2) patient global impression of change (PGIC) score of very much improved and much improved; and (3) physical function improvement of 6 or more points on Short Form-36 Physical Component Summary (SF-36 PCS)"|At the end of the three-month stable dose treatment phase|The primary efficacy analysis was performed based on intent-to-treat population defined as all randomized patients who took at least one dose of double-blind study medication. All subjects with missing assessments at the end of the three-month stable dose treatment phase were considered non-responders (baseline value carried forward (BOCF)).||Syndrome Responder Participants|||Number
722810|NCT00314249|Secondary|Change From Baseline in the Multi-Dimensional Fatigue Inventory (MFI) Total Score at Visit TX12.|"Change from Baseline in the Multi-Dimensional Fatigue Inventory (MFI) total score at TX12. Negative differences indicate decrease of fatigue.
MFI is a subjective report of fatigue symptoms consisting of 20 items that can be scored to produce 5 dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. The MFI is a 1-5 scale with 1=yes, that is true and 5=no, that is not true."|Baseline through end of week 12 (Visit TX12)|The analysis was performed based on intent-to-treat population defined as all randomized patients who took at least one dose of double-blind study medication. For all subjects with missing assessments at the end of week 12 (Visit TX12), values were imputed using Last Observation Carried Forward (LOCF).||units on scale||Standard Error|Mean
722811|NCT00314249|Secondary|Time-Weighted Average of Patient Global Impression of Change (PGIC) From Visit TX0-TX12.|"Time-weighted average (area under the curve [AUC]) for Patient Global Impression of Change (PGIC) from Visit TX0-TX12 is the area under the PGIC-time curve estimated using the trapezoidal method and normalized by time.
PGIC is an efficacy assessment on a scale of 1-7 taken at visits TX0-TX12. The wording of the assessment is as follows: Since the start of the study, overall my fibromyalgia is: 1=Very Much Improved, 2=Much Improved, 3=Minimally Improved, 4=No Change, 5=Minimally Worse, 6=Much Worse, and 7-Very Much Worse."|Weeks 1-12 (Visit TX0-TX12) of the stable dose treatment phase|The analysis was performed based on intent-to-treat population defined as all randomized patients who took at least one dose of double-blind study medication. For all subjects with missing assessments from weeks 1-12 of the stable dose treatment phase, values were imputed using last observation carried forward (LOCF).||units on scale||Standard Error|Mean
722812|NCT00314249|Secondary|Time-Weighted Average of Patient Experience Diary (PED) Reported Morning 24-Hour Recall Pain Scores for Weeks 1-12 of the Stable Dose Phase|"Time-weighted average (area under the curve [AUC]) of the weekly average Patient Experience Diary (PED)-reported morning recall pain scores for weeks 1 through 12 of the stable dose treatment phase is the area under the Patient Experience Diary (PED)-time curve estimated using the trapezoidal method and normalized by time.
PED is the Patient Experience Diary, an electronic diary system used for collection of patient self-reported pain data. Outcome measure is assessed using the VAS Pain Intensity Scale from 0-100 millimeters anchored at 0 mm (no pain) to 100 mm (worst possible pain)."|Weeks 1 through 12 of the stable dose treatment phase (Visit TX0-TX12)|The analysis was performed based on intent-to-treat population defined as all randomized patients who took at least one dose of double-blind study medication. For all subjects with missing assessments for weeks 1-12 of the stable dose treatment phase, values were imputed using last observation carried forward (LOCF).||units on scale||Standard Error|Mean
722813|NCT00314262|Primary|Clinical Outcome: Progression to a Higher-grade Dysplasia or Carcinoma|Response evaluation was based on pathologic examination of the degree of dysplasia observed and recorded by an expert head and neck pathologist. Pathologic complete response was defined as complete disappearance of dysplasia from the epithelium. Pathologic partial response was defined as improvement of dysplasia by at least one degree (i.e., severe dysplasia becomes moderate dysplasia). Pathologic minor response or stable disease was defined as minor focal improvement without change of degree of dysplasia (i.e., focal improvement from moderate to mild dysplasia with still moderate dysplasia overall) or no pathologic changes after treatment. Pathologic progressive disease was defined as worsening by at least one degree of dysplasia (i.e., mild to moderate dysplasia) or development of invasive cancer on or following treatment.|Up to 55 months from initiation of therapy. Median duration of follow-up was 36 months.|||participants|||Number
722814|NCT00314262|Primary|Clinical Outcome: Documented Progression|Response evaluation was based on pathologic examination of the degree of dysplasia observed and recorded by an expert head and neck pathologist. Pathologic complete response was defined as complete disappearance of dysplasia from the epithelium. Pathologic partial response was defined as improvement of dysplasia by at least one degree (i.e., severe dysplasia becomes moderate dysplasia). Pathologic minor response or stable disease was defined as minor focal improvement without change of degree of dysplasia (i.e., focal improvement from moderate to mild dysplasia with still moderate dysplasia overall) or no pathologic changes after treatment. Pathologic progressive disease was defined as worsening by at least one degree of dysplasia (i.e., mild to moderate dysplasia) or development of invasive cancer on or following treatment.|12 months from time of enrollment|||participants|||Number
722815|NCT00314262|Primary|Dose Escalation and Toxicity: Toxicities Including Grades 1 to 4|Participants received a fixed dose of celecoxib 400 mg orally BID continuously for 6 months. Erlotinib was dose escalated at 3 dose levels of 50, 75, and 100 mg orally every day for 6 months. Dose escalation followed a standard 3+3 escalation design.|12 months from time of enrollment|||participants|||Number
722816|NCT00314327|Secondary|Negative Symptoms||13 weeks||||||
722817|NCT00314327|Primary|Patient Acceptance of Injections||13 weeks||||||
722818|NCT00314327|Primary|Side Effects Based Upon Rating Instruments and Lab Tests||13 weeks||||||
722819|NCT00314327|Primary|Treatment Response Based Upon BPRS and CGI Ratings||13 weeks||||||
722833|NCT00314366|Secondary|Left Ventricular End-Systolic Volume (LVESV) (ml)|Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Left Ventricular End-Systolic Volume (LVESV) when the blood moves from the ventricles to the atria during the contraction cycle. Measured as volume in milliliters (ml). Normal is approximately 60- 65 milliliters.|baseline and 6 months|||ml||Standard Deviation|Mean
722861|NCT00319735|Secondary|Time to Relief of Dysphagia|To evaluate time to relief of dysphagia in patients with esophageal and GE junction carcinomas receiving preoperative radiation and cetuximab|36 months|No data was collected or analyzed for this secondary objective.|||||
722820|NCT00314340|Primary|3 Scores on the Addiction Research Center Inventory (ARCI)|The subjective effects of the study drug were evaluated with 3 subscales of the Addiction Research Center Inventory (ARCI). The subscales studied included Morphine–Benzedrine Group which measured euphoria (0-16 with higher numbers indicating more euphoria), the Phenobarbital–Chorpromazine–Alcohol Group which measured sedation (-3 to +11 with higher scores indicating more sedation), and the Lysergic Acid Diethylmide Group which measured dysphoria and agitation (-4 to +10 with higher scores indicating more dysphoria). This inventory consists of 49 true/ false questions which survey major domains of drug effects. The ARCI was measured at six timepoints. Of interest were trough sedation, peak euphoria, and trough dysphoria.|0, 60, 120, 180, 240, or 300 minutes|Treatment effects at baseline, 60, 120, 180, 240, and 300 min were assessed with repeated measures ANOVA. A liner mixed-effects model with inclusion of interaction terms (1) treatment and time and (2) random order visit number and time was performed.||scores on a scale||Standard Deviation|Mean
722821|NCT00314353|Secondary|Duration of Response||Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.||||||
722822|NCT00314353|Secondary|Overall Survival||Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.||||||
722823|NCT00314353|Secondary|Toxicity - Adverse Events||Assessments before each cycle of chemotherapy, after every third dose of bevacizumab (if given alone), and final adverse event assessment 3 months after the last dose of bevacizumab||||||
722824|NCT00314353|Secondary|Objective Response Rate||Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.||||||
722825|NCT00314353|Primary|One-year Progression-free Survival (PFS)|Outcome measure was not assessed due to early study closure. The study was closed early due to low enrollment and new information regarding the benefit of the study regimen.|Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.|Primary outcome measure was not assessed due to early study closure. The study was closed early due to low enrollment and new information regarding the benefit of the study regimen.|||||Number
722826|NCT00314366|Secondary|Total Severity Score (Reversible)|"For the severity test, cardiac SPECT polar mapping (gated dual-isotope) is used to evaluate myocardial cardiac perfusion, compared against a database with a statistically significant number of polar maps of healthy hearts and compared based on gender, data acquisition method, stress vs rest and type of data (i.e. perfusion, wall motion or wall thickening) using clinically validated software package (J Nucl Med Technol 2006; 34:3–17). The basal and mid-ventricle heart wall is mapped by cylindrical sampling and apex mapped by spheric, cylindric and radial sampling at rest/stress.
Total severity score is the sum of blackout pixels in rest/stress blackout polar map of myocardial perfusion cardiac SPECT imaging (adding scores in different views), weighted by number of SDs below mean. Total severity score reversible is total severity scores at rest subtracted from those during stress. The severity score varies from 0 (normal) to > 1000 (poor perfusion) but upper limit is not well defined."|baseline and 6 months|||units on a scale||Standard Deviation|Mean
722827|NCT00314366|Secondary|Total Severity Score (Rest)|"For the total severity score at rest, cardiac SPECT polar mapping (gated dual-isotope) is used to evaluate myocardial cardiac perfusion, compared against a database with a statistically significant number of polar maps of healthy hearts and compared based on gender, data acquisition method, stress vs rest and type of data (i.e. perfusion, wall motion or wall thickening) using a clinically validated software package (J Nucl Med Technol 2006; 34:3–17). The basal and mid-ventricle heart wall is mapped by cylindrical sampling and apex mapped by spheric, cylindric and radial sampling at rest.
Total severity score at rest is the sum of blackout pixels in the rest blackout polar map of myocardial perfusion cardiac SPECT imaging (adding scores in different views), weighted by the number of SDs below the mean.
Total severity score varies from 0 (normal) to several thousands although the upper limit is not well defined. A score greater than 1000 indicates poor perfusion."|baseline and 6 months|||units on a scale||Standard Deviation|Mean
722828|NCT00314366|Secondary|Total Severity Score (Stress)|"For the stress test, cardiac SPECT polar mapping (gated dual-isotope) is used to evaluate perfusion, compared against a database with a statistically significant number of polar maps of healthy hearts based on gender, data acquisition method, stress vs rest and type of data (i.e. perfusion, wall motion or wall thickening) using a clinically validated software package (J Nucl Med Technol 2006; 34:3–17). The basal and mid-ventricle heart wall is mapped by cylindrical sampling and apex mapped by spheric, cylindric and radial sampling.
Total severity score during stress is the sum of blackout pixels in the blackout polar map of myocardial perfusion during stress using cardiac SPECT imaging (adding scores in different views), weighted by the number of SDs below the mean.
Total severity score varies from 0 (normal) to several thousands although the upper limit is not well defined. A score greater than 1000 indicates poor perfusion."|baseline and 6 months|||units on a scale||Standard Deviation|Mean
722829|NCT00314366|Secondary|Echocardiography (EF) Percent (%)|Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Echocardiography measures ejection fraction(EF)as a percentage(%) of blood leaving the heart with each beat or contraction. It can provide information concerning structural characteristics and blood flow in the heart and blood vessels. A normal heart pumps 50-75% of the blood with each contraction.|baseline and 6 months|||percentage of blood||Standard Deviation|Mean
722830|NCT00314366|Secondary|Myocardial Oxygen Consumption (MVO2)|Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Myocardial Oxygen Consumption (MVO2)which is the amount of oxygen used by the heart muscle and is indicative of heart muscle function. Normal value is 15.5 Volume %. Measured as milliliters (ml) oxygen per kilogram (kg) body weight per minute.|baseline and 6 months|data from 9 stem cell patients at 6 months, 10 at baseline||ml/kg/min||Standard Deviation|Mean
722831|NCT00314366|Secondary|Echocardiography Wall Motion Score Index (WMSI)|Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Echocardiography Wall Motion Score Index (WMSI) as defined by the American Heart Association which allows detection of abnormalities in the heart wall or blood flowing through the heart. Using this model, the left ventricle is divided into 17 segments. Normal contracting Left Ventricle has WMSI of 1. Larger WMSI indicates higher degree of abnormalities (2 for hypokinetic, 3 for akinetic, 4 for dyskinetic, and 5 for aneurysmal). WMSI was calculated as the sum of scores divided by the total number of segments.|baseline and 6 months|||units on a scale||Standard Deviation|Mean
723579|NCT00324649|Secondary|Percent Change From Baseline in Hematocrit|Change = Week 48 value minus baseline value expressed as median percent change.|Baseline to Week 48|Treated participants. Missing values were excluded.||Percent change in hematocrit||Inter-Quartile Range|Median
722834|NCT00314366|Secondary|Echocardiography (EF)Percent (%)|Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Echocardiography measures ejection fraction(EF)as a percentage(%) of blood leaving the heart with each beat or contraction. It can provide information concerning structural characteristics and blood flow in the heart and blood vessels. A normal heart pumps 50-75% of the blood with each contraction.|Baseline and 6 months|||percentage of blood||Standard Deviation|Mean
722835|NCT00314366|Secondary|Canadian Cardiovascular (CCS) Angina Score|"Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Canadian Cardiovascular (CCS) Angina Score which indicates discomfort from angina (chest pain).
Class I- Angina only during strenuous or prolonged activity Class II- Slight limitation, with angina only during vigorous physical activity Class III- Symptoms with everyday living activities (moderate limitation) Class IV- Inability to perform any activity without angina or angina at rest (severe limitation)"|Baseline and 6 months|||units on a scale||Standard Deviation|Mean
722836|NCT00314366|Secondary|New York Heart Association (NYHA) Classification|"Clinical and functional assessment in endstage ischemic cardiomyopathy patients using New York Heart Association (NYHA)Classification and indicates extent of heart failure based on limitations in physical activity.
Class I- No symptoms/limitation in ordinary physical activity (shortness of breath when walking, etc) Class II-Mild symptoms/slight limitation during ordinary activity Class III- Marked limitation in activity due to symptoms, even during less-than-ordinary activity Class IV- Severe limitations in activity/experiences symptoms while at rest (bedbound)"|Baseline and 6 months|||NYHA Functional class||Standard Deviation|Mean
722837|NCT00314366|Primary|Safety of Aldehyde Dehydrogenase Bright Stem Cells Versus the Control Group as Measured by Combined Early and Late Adverse Events|Safety of cell injections was assessed by reviewing adverse events at 2 time points: Baseline (periprocedural period up to 2 weeks post-procedure) and at 6 months post-procedure. Major adverse events were adjudicated (hospitalization, arrhythmia, exacerbation of congestive HF [CHF], acute coronary syndrome, myocardial infarction, stroke, or death).|Baseline and 6 months|The data was analyzed for all participants in control and treated groups.||participants|||Number
722838|NCT00319696|Primary|Mean Change From Baseline at Each 16 Week Interval up to Week 80 in the UK Systemic Sclerosis Functional Score (UKFS)|UKFS relates to upper and lower extremity function and muscle weakness. For each item, the patient indicated the responses that best described their current ability: “able to perform in a normal manner,” “able to perform with alteration in style,” “can only manage with difficulty,” and “impossible to achieve.” Each response was given an integer from 0 (able to perform in a normal manner) to 3 (impossible to achieve), and the sum of individual responses provided an overall score of 0 to 33. Missing values were replaced with the worst value the patient reported on the other items at that visit.|80 weeks|number of participants at baseline, week 16, week 32, week 48, week 64, and week 80 was 116, 98, 93, 84, 82, and 78, respectively||score on a scale||Standard Deviation|Mean
722839|NCT00319696|Primary|Mean Changes From Baseline at Each 16 Week Interval up to Week 80 in Overall Hand Pain Related to Finger Ulcers|Overall hand pain related to finger ulcers was assessed by the patient using a Visual Analogue Scale. Patients were instructed to score their pain by marking on the continuous 10-cm scale, where 0 (left) was no pain and 100 (right) very severe pain, in response to the question, “How much pain have you had because of your finger ulcers in the past week?” The investigator measured the distance in millimeters between 0 and the patient mark with the ruler provided and recorded the distance.|80 weeks|number of participants at baseline, week 16, week 32, week 48, week 64, and week 80 was 110, 94, 89, 81, 76, and 73, respectively||mm||Standard Deviation|Mean
722840|NCT00319696|Primary|Mean Change From Baseline at Each 16 Week Interval up to Week 80 in Scleroderma Health Assessment Questionnaire (SHAQ) Individual Domain Score: Activity|"SHAQ evaluates physical disability. Patients were instructed to rate their capacity to perform activities of daily living within the previous 7 days by checking one of the following descriptors: without any difficulty, with some difficulty, with much difficulty, or unable to do, equivalent to scores of 0, 1, 2, and 3, respectively. Items were categorized into 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities."|80 weeks|number of participants at baseline, week 16, week 32, week 48, week 64, and week 80 was 116, 99, 93, 85, 82, and 78, respectively||scores on a scale||Standard Deviation|Mean
722841|NCT00319696|Primary|Mean Change From Baseline at Each 16 Week Interval up to Week 80 in Scleroderma Health Assessment Questionnaire (SHAQ) Individual Domain Score: Grip|"SHAQ evaluates physical disability. Patients were instructed to rate their capacity to perform activities of daily living within the previous 7 days by checking one of the following descriptors: without any difficulty, with some difficulty, with much difficulty, or unable to do, equivalent to scores of 0, 1, 2, and 3, respectively. Items were categorized into 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities."|80 weeks|number of participants at baseline, week 16, week 32, week 48, week 64, and week 80 was 116, 99, 93, 85, 82, and 78, respectively||scores on a scale||Standard Deviation|Mean
722842|NCT00319696|Primary|Mean Change From Baseline at Each 16 Week Interval up to Week 80 in Scleroderma Health Assessment Questionnaire (SHAQ) Individual Domain Score: Reach|"SHAQ evaluates physical disability. Patients were instructed to rate their capacity to perform activities of daily living within the previous 7 days by checking one of the following descriptors: without any difficulty, with some difficulty, with much difficulty, or unable to do, equivalent to scores of 0, 1, 2, and 3, respectively. Items were categorized into 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities."|80 weeks|number of participants at baseline, week 16, week 32, week 48, week 64, and week 80 was 116, 99, 93, 85, 82, and 78, respectively||scores on a scale||Standard Deviation|Mean
722843|NCT00319696|Primary|Mean Change From Baseline at Each 16 Week Interval up to Week 80 in Scleroderma Health Assessment Questionnaire (SHAQ) Individual Domain Score: Hygiene|"SHAQ evaluates physical disability. Patients were instructed to rate their capacity to perform activities of daily living within the previous 7 days by checking one of the following descriptors: without any difficulty, with some difficulty, with much difficulty, or unable to do, equivalent to scores of 0, 1, 2, and 3, respectively. Items were categorized into 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities."|80 weeks|number of participants at baseline, week 16, week 32, week 48, week 64, and week 80 was 116, 99, 93, 85, 82, and 78, respectively||scores on a scale||Standard Deviation|Mean
722844|NCT00319696|Primary|Mean Change From Baseline at Each 16 Week Interval up to Week 80 in Scleroderma Health Assessment Questionnaire (SHAQ) Individual Domain Score: Walking|"SHAQ evaluates physical disability. Patients were instructed to rate their capacity to perform activities of daily living within the previous 7 days by checking one of the following descriptors: without any difficulty, with some difficulty, with much difficulty, or unable to do, equivalent to scores of 0, 1, 2, and 3, respectively. Items were categorized into 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities."|80 weeks|number of participants at baseline, week 16, week 32, week 48, week 64, and week 80 was 116, 99, 93, 85, 82, and 78, respectively||scores on a scale||Standard Deviation|Mean
722845|NCT00319696|Secondary|Adverse Events Leading to Permanent Discontinuation of the Study Medication|Number of patients with an adverse event leading to permanent discontinuation of the study treatment|80 weeks|Study population||participants|||Number
722846|NCT00319696|Secondary|Serious Adverse Events up to 28 Days After Last Study Medication|Number of patients with at least one treatment-emergent serious adverse event. Adverse events that occurred after study drug initiation and up to 28 days after study drug discontinuation.|80 weeks|Study population||participants|||Number
722847|NCT00319696|Secondary|Adverse Events up to 24 Hours After Last Study Medication|Number of patients with at least one treatment-emergent adverse event. All adverse events that occurred after study drug initiation and up to 24 hours after study drug discontinuation were to be recorded.|80 weeks|Study population||participants|||Number
722848|NCT00319696|Primary|Mean Change From Baseline at Each 16 Week Interval up to Week 80 in Scleroderma Health Assessment Questionnaire (SHAQ) Individual Domain Score: Eating|"SHAQ evaluates physical disability. Patients were instructed to rate their capacity to perform activities of daily living within the previous 7 days by checking one of the following descriptors: without any difficulty, with some difficulty, with much difficulty, or unable to do, equivalent to scores of 0, 1, 2, and 3, respectively. Items were categorized into 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities."|80 weeks|number of participants at baseline, week 16, week 32, week 48, week 64, and week 80 was 116, 99, 93, 85, 82, and 78, respectively||scores on a scale||Standard Deviation|Mean
722849|NCT00319696|Primary|Mean Change From Baseline at Each 16 Week Interval up to Week 80 in Scleroderma Health Assessment Questionnaire (SHAQ) Individual Domain Score: Arising|"SHAQ evaluates physical disability. Patients were instructed to rate their capacity to perform activities of daily living within the previous 7 days by checking one of the following descriptors: without any difficulty, with some difficulty, with much difficulty, or unable to do, equivalent to scores of 0, 1, 2, and 3, respectively. Items were categorized into 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities."|80 weeks|number of participants at baseline, week 16, week 32, week 48, week 64, and week 80 was 116, 99, 93, 85, 82, and 78, respectively||scores on a scale||Standard Deviation|Mean
722850|NCT00319696|Primary|Mean Change From Baseline at Each 16 Week Interval up to Week 80 in Scleroderma Health Assessment Questionnaire (SHAQ) Individual Domain Score: Dressing|SHAQ evaluates physical disability. Patients were instructed to rate their capacity to perform activities of daily living within the previous 7 days by checking one of the following descriptors: “without any difficulty”, “with some difficulty,” “with much difficulty,” or “unable to do,” equivalent to scores of 0, 1, 2, and 3, respectively. Items were categorized into 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities.|80 weeks|number of participants at baseline, week 16, week 32, week 48, week 64, and week 80 was 116, 99, 93, 85, 82, and 78, respectively||scores on a scale||Standard Deviation|Mean
722851|NCT00319696|Primary|Time to Complete Healing of Each New DU||New DU occurence to healing|Complete healing of each new DU was not calculated due to the lack of effect on healing variables seen in the previous placebo-controlled study (RAPIDS 2). In consequence, the endpoint on DU healing originally planned time to complete healing of new DUs was not evaluated.|||||
722852|NCT00319696|Primary|Time to Complete Healing of Each Baseline DU||Baseline to healing|Complete healing of each baseline was not calculated due to the lack of effect on healing variables seen in the previous placebo-controlled study (RAPIDS 2). In consequence, the endpoint on time to complete healing of baseline DUs was not evaluated.|||||
722853|NCT00319696|Primary|Total Number of New Digital Ulcers (DUs) Per Patient Observed by the Investigator at Planned Visits|The total number of new DUs per patient observed by the investigator at planned visits and new transient DUs recorded in the patient diary (a patient diary was used to record DUs that might appear and disappear between two planned visits)were assessed at each clinic visit|At planned visits up to week 80|One patient did not have a DU at baseline (number of patients assessed at Weeks 0-4,4-8,8-16,16-24,24-32,32-40,40-48,48-56,56-64,64-72, and 72-80 were 114, 107, 103, 100, 97, 94, 88, 87, 86, 86, and 83, respectively.||number of new digital ulcers|||Number
722854|NCT00319735|Secondary|Complete and Partial Response Rate for Patients by Histology: Squamous Cell|To evaluate complete and partial response rate of preoperative radiation and cetuximab in patients with esophageal and GE junction carcinomas|36 months|patients with IIB||percentage of participants|||Number
722855|NCT00319735|Secondary|Complete and Partial Response Rate for Patients by Histology: Adenocarcinoma|To evaluate complete and partial response rate of preoperative radiation and cetuximab in patients with esophageal and GE junction carcinomas|36 months|patients with IIB||percentage of participants|||Number
722856|NCT00319735|Secondary|Complete and Partial Response Rate for Patients by Disease Stage: III|To evaluate complete and partial response rate of preoperative radiation and cetuximab in patients with esophageal and GE junction carcinomas|36 months|patients with Stage III disease||percentage of participants|||Number
722857|NCT00319735|Secondary|Complete and Partial Response Rate for Patients by Disease Stage: IIB|To evaluate complete and partial response rate of preoperative radiation and cetuximab in patients with esophageal and GE junction carcinomas|36 months|patients with IIB||percentage of participants|||Number
722858|NCT00319735|Secondary|Complete and Partial Response Rate for Patients by Disease Stage: IIA|To evaluate complete and partial response rate of preoperative radiation and cetuximab in patients with esophageal and GE junction carcinomas|36 months|patients with IIA||percentage of participants|||Number
722859|NCT00319735|Secondary|Perform Exploratory Molecular Correlates.|To perform exploratory molecular correlates to determine the mechanisms of response and resistance to cetuximab and radiation therapy.|36 months|No data was collected or analyzed for this secondary objective.|||||
722862|NCT00319735|Secondary|Complete Pathological Response Rate for Patients Who Underwent Esophagectomy.|"To evaluate complete pathologic response rate in patients with esophageal and GE junction carcinomas that underwent esophagectomy.
Complete pathologic response (pCR) is defined as the absence of tumor cells on the resected specimen in the esophagus and/or GE junction."|Up to 36 months|Participants who underwent esophagectomy||percentage of participants||95% Confidence Interval|Number
722863|NCT00319735|Primary|Complete Pathologic Response (pCR)|"To evaluate complete pathologic response rate in patients with esophageal and GE junction carcinomas.
Complete pathologic response (pCR) is defined as the absence of tumor cells on the resected specimen in the esophagus and/or GE junction."|36 months|||percentage of participants|||Number
722864|NCT00319748|Secondary|Mean Difference Values for Tumor Necrosis Factor-alpha (TNF-a)|Measures difference in Tumor necrosis factor-alpha (cytokine) values as a means of immune activation pre-treatment and 6 hours post-treatment in patients that received at least one dose of study treatment with 852A.|Prior to Dose 1 and 6 Hours Post-Dose|Only 9 patients had recorded values at 6 hours after treatment and were included in analysis.||pg/mL||95% Confidence Interval|Mean
722865|NCT00319748|Secondary|Mean Difference Values for Soluble CD40 Ligand (sCD40L)|Measures difference in Soluble CD40 ligand (cytokine) values as a means of immune activation pre-treatment and 6 hours post-treatment in patients that received at least one dose of study treatment with 852A.|Prior to Dose 1 and 6 Hours Post-Dose|One patient did not have recorded value at 6 hours after treatment and cannot be included in analysis.||pg/mL||95% Confidence Interval|Mean
722866|NCT00319748|Secondary|Mean Difference Values for Macrophage Inflammatory Protein-1 Beta (MIP-1b)|Measures difference in Macrophage Inflammatory Protein-1 Beta (cytokine) values as a means of immune activation pre-treatment and 6 hours post-treatment in patients that received at least one dose of study treatment with 852A.|Prior to Dose 1 and 6 Hours Post-Dose|Two patients did not have recorded values at 6 hours after treatment so cannot be included in analysis.||pg/mL||95% Confidence Interval|Mean
722867|NCT00319748|Secondary|Mean Difference Values for Macrophage Inflammatory Protein-1 Alpha (MIP-1a)|Measures difference in MIP-1a (cytokine) values as a means of immune activation pre-treatment and 6 hours post-treatment in patients that received at least one dose of study treatment with 852A.|Prior to Dose 1 and 6 Hours Post-Dose|Only 5 patients had a value reported at 6 hours after treatment.||pg/mL||95% Confidence Interval|Mean
722868|NCT00319748|Secondary|Mean Difference Values for 10 kDa Interferon-gamma-induced Protein (IP-10)|Measures differences in IP-10 (cytokine) values as a means of immune activation pre-treatment and 6 hours post-treatment in patients that received at least one dose of study treatment with 852A.|Prior to Dose 1 and 6 Hours Post-Dose|One patient did not have a value reported at 6 hours after treatment so cannot be included in analysis.||pg/mL||95% Confidence Interval|Mean
722869|NCT00319748|Secondary|Mean Difference Values for Interleukin 1 Receptor Antagonist (IKL1ra)|Measures the difference of IL1ra (cytokine) values as a means of immune activation pre-treatment and 6 hours post-treatment in patients that received at least one dose of study treatment with 852A.|Prior to Dose 1 and 6 hours after Dose 1|One patient did not have value reported at 6 hours after treatment, so cannot be included.||pg/mL||95% Confidence Interval|Mean
722870|NCT00319748|Primary|Patients With Tumor Response (Response Evaluation Criteria in Solid Tumors) Who Received All 24 Doses of 852A.|Assessment of anti-tumor activity of 852A using Response Evaluation Criteria in Solid Tumors (RECIST) criteria to evaluate tumor response after 24 doses. Complete Response (CR)= disappearance of all target lesions, Partial Response (PR) = at least 30% decrease in sum of longest diameter of target lesions, Progressive Disease (PD) = at least 25% increase in sum of longest diameter of target lesions, Stable Disease = neither PR or PD.|after 12 weeks (24 doses of 852A)|Includes only patients that received all 24 doses of 852A.||Participants|||Number
722871|NCT00319982|Secondary|Impact of Diltiazem on Systolic Blood Pressure|Change in Value (Difference between Final and Baseline Visits)|Baseline and final study visits|||mmHg||Standard Error|Mean
722872|NCT00319982|Secondary|Adherence to Study Medication|Adherence to study medication was assessed by pill count|Duration of the trial|||percentage of pills taken||Standard Deviation|Median
722873|NCT00319982|Secondary|Development of Left Ventricular Hypertrophy|The number of participants who developed overt left ventricular hypertrophy during the duration of the trial was analyzed|Baseline through final study visits|||participants|||Number
722874|NCT00319982|Secondary|Left Ventricular Cavity Size|Change in Left Ventricular End-Diastolic Diameter z-score (Final Value - Baseline Value)|Baseline and final study visits|||z-score units||Standard Error|Mean
722875|NCT00319982|Secondary|Impact of Diltiazem on Heart Rate|Change in Value (Difference between Final and Baseline Visits)|Baseline and final study visits|||beats/minute||Standard Error|Mean
722876|NCT00319982|Secondary|Safety and Tolerability of Diltiazem Treatment|Adverse events were compared between participants assigned to diltiazem and those assigned to placebo|Baseline through final study visits|||Participants Reporting Adverse Events|||Number
722877|NCT00319982|Primary|Increase, Stability of, or Decrease in the Decline of Diastolic Function as Reflected by the Global Early Myocardial Relaxation (E') Velocity|The change in E' velocity (difference between final value - baseline value) was compared between participants who received diltiazem and those who received placebo to gauge treatment response. Please note that the total duration on treatment varied between study subjects to maximize time on treatment for the trial. Specifically, subjects that enrolled earliest had the longest duration of treatment; those who enrolled latest had the shortest duration of treatment with a minimum treatment duration of 1 year. All analyses examine the final study visit on treatment to the baseline visit.|Baseline and final study visits|||cm/sec (difference final-baseline)||Standard Error|Mean
722878|NCT00320112|Secondary|Number of Participants With Insulin Starts at 6 Months|the number of insulin starts at 6 months from baseline.|6 months (baseline to 6 months follow-up)|medical charts were reviewed to obtain this information and all participant charts were reviewed||participants|||Number
722879|NCT00320112|Secondary|Change in Diastolic Blood Pressure|change in diastolic blood pressure was measured at 6 months|6 months from baseline|As noted earlier, for physiologic measures only 113 of the 125 peer support participants were able to provide 6 month follow-up data and 103 of 119 nurse management group provided 6 month follow-up data.||mmHg||Standard Deviation|Mean
723580|NCT00324649|Secondary|Change From Baseline in Hemoglobin|Change = Week 48 value minus baseline value.|Baseline to Week 48|Treated participants. Missing values were excluded.||g/dL||Inter-Quartile Range|Median
722880|NCT00320112|Secondary|Change in Systolic Blood Pressure Measure|secondary outcome measure was change in blood pressure comparison of peer support group and nurse case management group from baseline to six months|change in blood pressure at 6 months|comparison of blood pressure measure taken at baseline and then again at 6 months among the two groups. as noted, 113 peer support participants provided physiologic measures at 6 months and 103 of 119 from the nurse management group provided physiologic measures at 6 months.||mmHg||Standard Deviation|Mean
722881|NCT00320112|Primary|Change in Glycemic Control (HbA1c)|The primary outcome was change between baseline and six-month Hemoglobin A1c (HbA1c), measured with a Bayer DCA 2000+ point-of-care analyzer.|6 months (baseline to 6 months)|Peer Support group: 117 of the 125 provided 6 month data and 113 provided physiologic measures. Nurse Case management participants: 114 of 119 provided 6 month data and 103 provided follow-up physiologic measures.||percent HbA1c||Standard Deviation|Mean
722882|NCT00320190|Secondary|Median Time to Progression-free Survival|Progression-free survival is defined as the time in days from randomization to progressive disease documented by the investigator or to death from any cause without prior progression. Participants without progressive disease or who do not die and complete the 12-month treatment are censored on the date of their last molecular, cytogenetic, or hematologic assessment.|Randomization to disease progression or death (to 12 months)|Efficacy analyses as originally described in the protocol were not conducted because of the low number of participants enrolled.|||||
722883|NCT00320190|Secondary|Median Time to Treatment Failure|Time to treatment failure is defined as the time in days from randomization to progressive disease documented by the investigator, to death from any cause without prior progression, or to early treatment discontinuation for any reason, whichever occurs first. Participants without disease progression or who do not die and complete the 12-month study treatment are censored on the date of their last molecular, cytogenetic, or hematologic assessment.|Randomization to disease progression, death, or discontinuation (to 12 months)|Efficacy analyses as originally described in the protocol were not conducted because of the low number of participants enrolled.|||||
722884|NCT00320190|Secondary|Percentage of Participants With Complete Cytogenetic Response|Cytogenetic response is based on the prevalence of Ph+ metaphases among cells in metaphase in a bone marrow sample.|At 6 and 12 months from baseline|Efficacy analyses as originally described in the protocol were not conducted because of the low number of participants enrolled.|||||
722885|NCT00320190|Secondary|Median Time to MMolR|Time to MMolR is defined as the time from first treatment dose until measurement criteria are first met for MMolR. MMolR is defined as a reduction in transcript levels of the BCR-ABL gene of at least 3 log from baseline.|At 3, 6, 9, and 12 months from baseline|Efficacy analyses as originally described in the protocol were not conducted because of the low number of participants enrolled.|||||
722886|NCT00320190|Secondary|Percentage of Participants With On-study AEs of Special Interest|GI=gastrointestinal. AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with treatment. Grade 1=mild; Grade 2=moderate; Grade 3=severe and undesirable; Grade 4=life-threatening or disabling; Grade 5=death. Percentages based on the number of participants with a specific grade at baseline. Participants without on-study test values for a particular laboratory analyte are not included in the reporting of that analyte.|Months 1 to 12, continuously, and Months 12 to 24, continuously|All participants who received at least 1 dose of dasatinib or imatinib.||Percentage of Participants|||Number
722887|NCT00320190|Secondary|Percentage of Participants With Death as Outcome, Adverse Events (AEs), Treatment-related AEs, Serious Adverse Events (SAEs), Treatment-related SAEs, and AEs Leading to Discontinuation|AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with treatment. SAE=any untoward medical occurrence that at any dose results in death, persistent or significant disability/incapacity, drug dependency, or drug abuse; prolongs inpatient hospitalization; or is life-threatening, a congenital anomaly/birth defect, or an important medical event. Treatment related=possibly, probably, or certainly related to and of unknown relationship to study treatment.|Months 1 to 12, continuously, and Months 12 to 24, continuously|All participants who received at least 1 dose of dasatinib or imatinib.||Percentage of participants|||Number
722888|NCT00320190|Primary|Percentage of Participants With Chronic Phase Chronic Myeloid Leukemia Who Have a Major Molecular Response (MMolR)|MMolR is defined as reduction in transcript levels of the breakpoint cluster region (BCR)-V-abl Abelson murine leukemia viral oncogene homolog 1 (ABL) gene of at least 3 log. The BCR-ABL gene has a role in the production of a mutated protein that converts bone marrow stem cells from normal to leukemic.|At 12 months from baseline|Efficacy analyses as originally described in the protocol were not conducted because of the low number of participants enrolled.|||||
722889|NCT00320216|Secondary|Number of Participants Who Achieved Psoriasis Area Severity Index (PASI) 75% Improvement (0-72) at Week 28|Psoriasis Area and Severity Index (PASI)(0 [ best] -72 [worst]) score at Week 28 for participants who were retreated at Week 16. This is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score.|Week 28|Participants were included in the analysis according to the assigned treatment groups. Participant is considered a non- responder if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy. Other missing data were not imputed.||Participants|||Number
722890|NCT00320216|Secondary|Number of Participants Who Achieved Psoriasis Area Severity Index (PASI) 75% Improvement at Week 32|Psoriasis Area and Severity Index (PASI)(0 [ best] -72 [worst]) score at Week 32 for participants who were not retreated at Week 16. This is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score.|Week 32|Participants were included in the analysis according to the assigned treatment groups. Participant is considered a non- responder if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy. Other missing data were not imputed.||Particpants|||Number
722901|NCT00320255|Secondary|Number of Participants With Deep Vein Thrombosis|"Any 1 of the following was considered diagnostic for DVT:
New or previously undocumented noncompressibility of 1 or more proximal venous segments of the legs on CUS
Constant intraluminal filling defects on 2 or more views on contrast venography in 1 or more venous segments in the legs or pelvis or involving the inferior vena cava."|First dose to 2 days following last dose of study drug|All participants who received at least 1 dose of study drug||Participants||95% Confidence Interval|Number
722891|NCT00320216|Secondary|Number of Participants Who Achieved Physician's Global Assessment (PGA) Score of Clear (1) or Excellent (2) at Week 12|Number of participants achieving a physician global assessment (PGA)(1 [best] to 6 [worst]) score of clear or excellent at Week 12. The PGA is used to determine the participants psoriasis lesions overall at a given time point. Overall lesions will be graded for induration, erythema, and scaling. The sum of the 3 scales will be divided by 3 to obtain a final PGA score.|Week 12|Participants were included in the analysis according to the assigned treatment groups. Participant is considered a non- responder if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy. Other missing data were not imputed.||Participants|||Number
722892|NCT00320216|Primary|Number of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75% Improvement at Week 12|Psoriasis Area and Severity Index (PASI)(0 [ best] -72 [worst]) score at Week 12. This is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score.|Week 12|Intent to treat. All participants randomized were included in the analysis according to the assigned treatment groups. Participant is considered a non- responder if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy.||Participants|||Number
722893|NCT00320242|Secondary|Percentage Change in Falls|The mean change in fall frequency from the baseline period without the laserlight visual cue compared to the subsequent period during which they used the laserlight visual cue among subjects experiencing at least one fall during the baseline and subsequent study periods. This outcome measure is expressed as a percentage change from the baseline period.|1 to 2 months|10 Study Participants who completed protocol and who met a predetermined criterion for this subgroup analysis by experiencing one or more falls during both baseline and the subsequent study period. This excludes the 6 subjects who dropped out before any exposure to the laserlight visual cue||% change in fall frequency||Standard Deviation|Mean
722894|NCT00320242|Secondary|Mean Change in Number of Falls Without Versus With the Laserlight Visual Cue.|Mean change in falls per week for the period between visit 1 and visit 2 (without laserlight visual cue) compared to the period between visit 2 and visit 3 (with the laserlight visual cue).|2-3 months|10 Study Participants who completed protocol and who met a predetermined criterion for this subgroup analysis by experiencing one or more falls during both baseline and the subsequent study period. This excludes the 6 subjects who dropped out before any exposure to the laserlight visual cue||falls per week||Standard Deviation|Mean
722895|NCT00320242|Secondary|Mean Change in Time to Perform the Timed Gait Test With vs Without the Laser Feature|Mean change in time to perform the timed gait test with versus without the laser feature from visit 1 to visit 3. It was pre-specified that all 26 subjects would be treated as a single group with respect to the outcome measure regardless of whether or not they had a 1 month or 2 month baseline period|2-3 months|All 26 subjects who entered the study and completed the protocol, so this excludes the 6 subjects who dropped out before any exposure to the laserlight visual cue||seconds||Standard Deviation|Mean
722896|NCT00320242|Primary|Mean Change From Baseline (Visit 1 Until Visit 2) to Endpoint (After Visit 2 Until Visit 3) in the Freezing of Gait Questionnaire Score.|The FOGQ has a minimum of 0 and max of 4 for each question, with 4 representing more severe freezing of gait. There are 6 questions, so the total score ranges from 0 to 24. It was pre-specified that all 26 subjects were treated as a single group with respect to the primary outcome measure regardless of whether or not they had a 1 month or 2 month baseline period.|2-3 months|These 13 subjects were those who were reandomized to a 1 month baseline before use of the laserlight visual cue.||change in FOGQ score||Standard Error|Mean
722897|NCT00320255|Primary|Number of Participants With Composite of Confirmed Major Bleeding and Clinically Relevant Nonmajor (CRNM) Bleeding|"Major bleeding was defined as clinically overt bleeding accompanied by 1 or more of the following:
A decrease in hemoglobin of 20 g/L or more or
Required transfusion of 2 or more units of packed red blood cells or whole blood, or
Occurred in a critical site
Contributed to death.
CRNM bleeding was defined as bleeding that did not meet the criteria for major bleeding but that, in routine clinical practice, would be considered relevant and not trivial by a patient and physician. Such bleeding satisfied a priori criteria defined by the ICAC, including:
Skin hematoma
Epistaxis that lasted for longer than 5 minutes, was repetitive, or led to an intervention
Hematuria that was macroscopic and either spontaneous or lasted for longer than 24 hours after instrumentation of the urogenital tract
Any other bleeding type that was considered to have clinical consequences."|From first dose to 2 days following last dose of study drug|All participants who received at least 1 dose of study drug||Participants||95% Confidence Interval|Number
722898|NCT00320255|Secondary|Number of Participants Who Died and With Adverse Events (AEs), Serious Adverse Events (SAEs), Bleeding AEs, and Discontinuations Due to AEs|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|First dose to 2 days following last dose of study drug|All participants who received at least 1 dose of study drug||Participants|||Number
722899|NCT00320255|Secondary|Number of Participants With Proximal Deep Vein Thrombosis|"Any 1 of the following was considered diagnostic for DVT:
New or previously undocumented noncompressibility of 1 or more proximal venous segments of the legs on CUS
Constant intraluminal filling defects on 2 or more views on contrast venography in 1 or more venous segments in the legs or pelvis or involving the inferior vena cava."|First dose to 2 days following last dose of study drug|All participants who received at least 1 dose of study drug||Participants||95% Confidence Interval|Number
722900|NCT00320255|Secondary|Number of Participants With Distal Deep Vein Thrombosis|"Any 1 of the following was considered diagnostic for DVT:
New or previously undocumented noncompressibility of 1 or more proximal venous segments of the legs on CUS
Constant intraluminal filling defects on 2 or more views on contrast venography in 1 or more venous segments in the legs or pelvis or involving the inferior vena cava."|First dose to 2 days following last dose of study drug|All participants who received at least 1 dose of study drug||Participants||95% Confidence Interval|Number
722917|NCT00320281|Primary|Numerical Rating Scale-NRS|"The Numerical Rating Scale (NRS) is a numerical scale from 0-10 used to rate pain. Participants were asked to assess the worst pain experienced in the past 5 days and rate it on a numerical scale from 0-10, with 10 being the worst possible pain they have experienced and 0 being no pain."|6 weeks post-injection|||units on a scale||95% Confidence Interval|Mean
722902|NCT00320255|Secondary|Number of Participants With Nonfatal Pulmonary Embolism|"Any 1 of the following was considered diagnostic for PE:
Constant intraluminal filling defects in 2 or more views on pulmonary angiography
Sudden contrast cutoff of 1 or more vessels more than 2.5 mm in diameter on a pulmonary angiogram
A high probability VQ lung scan showing 1 or more segmental perfusion defects with corresponding normal ventilation (mismatch defect)
An abnormal VQ lung scan with satisfaction of either criterion 1 or 2
Abnormal spiral computed tomography scan showing thrombus in pulmonary vessels."|First dose to 2 days following last dose of study drug|||Participants||95% Confidence Interval|Number
722903|NCT00320255|Secondary|Number of Participants With Pulmonary Embolism (Fatal or Nonfatal)|"Any 1 of the following was considered diagnostic for PE:
Constant intraluminal filling defects in 2 or more views on pulmonary angiography
Sudden contrast cutoff of 1 or more vessels of greater than 2.5 mm in diameter on a pulmonary angiogram
A high probability VQ lung scan showing 1 or more segmental perfusion defects with corresponding normal ventilation (mismatch defect)
An abnormal VQ lung scan with satisfaction of either criterion 1 or 2
Abnormal spiral computed tomography scan showing thrombus in pulmonary vessels."|First dose to 2 days following last dose of study drug|All participants who received at least 1 dose of study drug||Participants||95% Confidence Interval|Number
722904|NCT00320255|Secondary|Number of Participants With All-Cause Death||First dose to 2 days following last dose of study drug|All participants who received at least 1 dose of study drug||Participants||95% Confidence Interval|Number
722905|NCT00320255|Secondary|Number of Participants With Composite of Proximal Deep Vein Thrombosis (DVT), Nonfatal Pulmonary Embolism (PE), and Venous Thromboembolism (VTE)-Related Death|"VTE includes symptomatic DVT and PE. Any 1 of the following was considered diagnostic for DVT:
New or previously undocumented noncompressibility of 1 or more proximal venous segments of the legs on CUS
Constant intraluminal filling defects on 2 or more views on contrast venography in 1 or more venous segments in the legs or pelvis or involving the inferior vena cava.
Any 1 of the following was considered diagnostic for PE:
Constant intraluminal filling defects in 2 or more views on pulmonary angiography
Sudden contrast cutoff of 1 or more vessels more than 2.5 mm in diameter on a pulmonary angiogram
A high probability VQ lung scan showing 1 or more segmental perfusion defects with corresponding normal ventilation (mismatch defect)
An abnormal VQ lung scan with satisfaction of either criterion 1 or 2
Abnormal spiral computed tomography scan showing thrombus in pulmonary vessels."|First dose to 2 days following last dose of study drug|All participants who received at least 1 dose of study drug||Participants||95% Confidence Interval|Number
722906|NCT00320255|Secondary|Number of Participants With Composite of Venous Thromboembolism (VTE) and VTE-related Death|"VTE includes symptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE). Any 1 of the following was considered diagnostic for DVT:
New or previously undocumented noncompressibility of 1 or more proximal venous segments of the legs on CUS
Constant intraluminal filling defects on 2 or more views on contrast venography in 1 or more venous segments in the legs or pelvis or involving the inferior vena cava.
Any 1 of the following was considered diagnostic for PE:
Constant intraluminal filling defects in 2 or more views on pulmonary angiography
Sudden contrast cutoff of 1 or more vessels more than 2.5 mm in diameter on a pulmonary angiogram
A high probability VQ lung scan showing 1 or more segmental perfusion defects with corresponding normal ventilation (mismatch defect)
An abnormal VQ lung scan with satisfaction of either criterion 1 or 2
Abnormal spiral computed tomography scan showing thrombus in pulmonary vessels."|First dose to 2 days following last dose of study drug|All participants who received at least 1 dose of study drug||Participants||95% Confidence Interval|Number
722907|NCT00320255|Secondary|Number of Participants With Proximal Deep Vein Thrombosis (DVT), Nonfatal Pulmonary Embolism (PE), and All-cause Death|"Any 1 of the following was considered diagnostic for DVT:
New or previously undocumented noncompressibility of 1 or more proximal venous segments (popliteal vein or higher) of the legs on CUS
Constant intraluminal filling defects on 2 or more views on contrast venography in 1 or more venous segments in the legs or pelvis or involving the inferior vena cava.
Any 1 of the following was considered diagnostic for PE:
Constant intraluminal filling defects in 2 or more views on pulmonary angiography
Sudden contrast cutoff of 1 or more vessels more than 2.5 mm in diameter on a pulmonary angiogram
A high probability VQ lung scan showing 1 or more segmental perfusion defects with corresponding normal ventilation (mismatch defect)
An abnormal VQ lung scan (nonhigh probability) with satisfaction of either criterion 1 or 2
Abnormal spiral computed tomography scan showing thrombus in pulmonary vessels."|First dose to 30 days following last dose of study drug|All participants who received at least 1 dose of study drug||Participants||95% Confidence Interval|Number
722908|NCT00320255|Secondary|Number of Participants With Composite of Venous Thromboembolism (VTE) and All-cause Death|"VTE includes symptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE). Any 1 of the following was considered diagnostic for DVT:
New or previously undocumented noncompressibility of 1 or more proximal venous segments of the legs on CUS
Constant intraluminal filling defects on 2 or more views on contrast venography in 1 or more venous segments in the legs or pelvis or involving the inferior vena cava.
Any 1 of the following was considered diagnostic for PE:
Constant intraluminal filling defects in 2 or more views on pulmonary angiography
Sudden contrast cutoff of 1 or more vessels more than 2.5 mm in diameter on a pulmonary angiogram
A high probability VQ lung scan showing 1 or more segmental perfusion defects with corresponding normal ventilation (mismatch defect)
An abnormal VQ lung scan with satisfaction of either criterion 1 or 2
Abnormal spiral computed tomography scan showing thrombus in pulmonary vessels."|First dose to 2 days following last dose of study drug|All participants who received at least 1 dose of study drug||Participants||95% Confidence Interval|Number
722909|NCT00320281|Secondary|Rehabilitation Interference Scale (RIS)||2 weeks and 6 weeks post-injection||||||
722910|NCT00320281|Secondary|Respiratory Function Measures||2 weeks and 6 weeks post-injection||||||
722911|NCT00320281|Secondary|Patient Global Outcome Ratings||2 weeks, 6 weeks, and 6 months post-injection||||||
722912|NCT00320281|Secondary|Cervical Range of Motion Measurements||2 weeks and 6 weeks post-injection||||||
722913|NCT00320281|Secondary|Beck Depression Inventory||2 weeks and 6 weeks post-injection||||||
722914|NCT00320281|Secondary|Modified Leeds Neuropathic Symptoms and Signs Scale||2 weeks, 6 weeks, and 6 months post-injection||||||
722915|NCT00320281|Primary|Short-Form McGill Pain Questionnaire||2 weeks, 6 weeks, and 6 months post-injection||||||
722916|NCT00320281|Primary|Brief Pain Inventory-SF||2 weeks, 6 weeks, and 6 months post-injection||||||
722918|NCT00320372|Secondary|Predictors of Suicidality Based on Montgomery Asberg Depression Rating Scale (MADRS) Item 10 Score - Primary Diagnosis of MDE|This assessment was completed by the physician at the screening visit. The physician decided which DSM-IV Diagnosis (as shown in outcome measure data table) best characterized the patient's primary diagnosis of MDE.|Screening|D-23 Original + TAU [(n= 330) + (n= 276)]. These risk factors assessed at baseline and pre-baseline were not collected with respect to treatment, therefore this information is not presented by treatment arm.||Percentage of Patients|||Number
722919|NCT00320372|Secondary|Predictors of Suicidality Based on Montgomery Asberg Depression Rating Scale (MADRS) Item 10 Score - Intent of Most Recent Suicidal Gesture|"This assessment was completed by the physician at the baseline visit in a clinical interview. The physician decided which category (as shown in outcome measure data table) best characterized the patient's intent of their most recent suicidal gesture or attempt.
Total number of patients analyzed may be lower than ITT in a case of missing assessment data."|Baseline|D-23 Original + TAU [(n= 330) + (n= 276)] minus 159 missing assessment data. These risk factors assessed at baseline and pre-baseline were not collected with respect to treatment, therefore this information is not presented by treatment arm.||Percentage of Patients|||Number
722920|NCT00320372|Secondary|Predictors of Suicidality Based on Montgomery Asberg Depression Rating Scale (MADRS) Item 10 Score - Medical Threat to Life of Most Recent Suicidal Gesture|"This assessment was completed by the physician at the baseline visit in a clinical interview. The physician decided which category (as shown in outcome measure data table) best characterized the patient's medical threat to life of their most recent suicidal gesture or attempt.
Total number of patients analyzed may be lower than ITT in a case of missing assessment data."|Baseline|D-23 Original + TAU [(n= 330) + (n= 276)] minus 159 missing assessment data. These risk factors assessed at baseline and pre-baseline were not collected with respect to treatment, therefore this information is not presented by treatment arm.||Percentage of Patients|||Number
722921|NCT00320372|Post-Hoc|Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) Change From Baseline by Visit Month|The Q-LES-Q-SF is a self-report scale to assess the degree of enjoyment and satisfaction experienced by the patient during the past week. There are 2 forms of this instrument: the short form and the long form. The short form employs the 14 general activities included in the long form, as well as 2 global items. Five-point item scores (1 to 5) are aggregated, with higher scores indicative of greater enjoyment or satisfaction in each domain. The scoring of the Q-LESQ-SF involves summing only the first 14 items to yield a raw total score. The last 2 items are not included in the total score but stand alone. The raw total score ranges from 14 (worst score) to 70 (best score). Higher Q-LES-QSF score indicates more enjoyment and satisfaction (Endicott, Nee et al. 1993).|3-Month Through 60-Month (Post Baseline)|ITT Population minus D-21 Subjects: VNS Therapy Population (D-23=330) + (n= 276) TAU population. The total number of patients in each group is lower than ITT due to missing assessment data, for which a large portion is that of D-21 subjects. The Q-LES-Q-SF was not collected in the D-21 Study.||units on a scale||Standard Deviation|Mean
722922|NCT00320372|Secondary|Predictors of Suicidality Based on Montgomery Asberg Depression Rating Scale (MADRS) Item 10 Score - Baseline MADRS Item 10 Suicidal Ideation|"This assessment was completed telephonically by a third party rater (Central Rater Group). The rating was based on a clinical interview moving from broadly phrased questions about symptoms to more detailed ones, which allowed a precise rating of severity. The rater decided whether the rating lied on the defined scale steps (0, 2, 4, 6) or between them (1, 3, 5) and then checked the appropriate selection on the MADRS Item 10 Suicidal Thoughts (Ideation).
Total number of patients analyzed may be lower than ITT in a case of missing assessment data."|1 Week Pre-Baseline|D-23 Original + TAU [(n= 330) + (n= 276)] minus 2 missing assessment data. These risk factors assessed at baseline and pre-baseline were not collected with respect to treatment, therefore this information is not presented by treatment arm.||Percentage of Patients|||Number
722923|NCT00320372|Post-Hoc|Mortality and Suicidality in Safety Population (Suicides/1000 Person Years)|The number of suicides per calculated 1000 person years.|3-Month Through 60-Month (Post Baseline)|Safety Population (SP): VNS Therapy Population (n=494 (D-23=335 + D-21=159)) + (n= 301) TAU population||Number of Suicides Per 1000 Person Years|||Number
722924|NCT00320372|Post-Hoc|Mortality and Suicidality in Safety Population (Number of Suicides)|The number suicides on the study were collected from the baseline visit.|3-Month Through 60-Month (Post Baseline)|Safety Population (SP): VNS Therapy Population (n=494 (D-23=335 + D-21=159)) + (n= 301) TAU population||Number of Suicides|||Number
722925|NCT00320372|Post-Hoc|Mortality and Suicidality in Safety Population (All-Cause Mortality/1000 Person Years)|All cause mortality is defined as the number of deaths per calculated 1000 person years.|3-Month Through 60-Month (Post Baseline)|Safety Population (SP): VNS Therapy Population (n=494 (D-23=335 + D-21=159)) + (n= 301) TAU population||Deaths Per 1000 Person Years|||Number
722926|NCT00320372|Post-Hoc|Mortality and Suicidality in Safety Population (Total Patient Years Exposed)|Treatment exposure time in years for all patients for all treatment groups were calculated in 1000 person year measure.|3-Month Through 60-Month (Post Baseline)|Safety Population (SP): VNS Therapy Population (n=494 (D-23=335 + D-21=159)) + (n= 301) TAU population||Exposure Per 1000 Patient Years|||Number
722927|NCT00320372|Post-Hoc|Mortality and Suicidality in Safety Population (Total Number of Deaths)|The number of deaths on the study were collected from the baseline visit.|3-Month (baseline or implantation) Through 60-Month (Post Baseline)|Safety Population (SP): VNS Therapy Population (n=494 (D-23=335 + D-21=159)) + (n= 301) TAU population||Number of Deaths|||Number
722928|NCT00320372|Secondary|Montgomery Asberg Depression Rating Scale (MADRS)% Remitters (MADRS Total Score ≤9 at Visit Month Assessment Post-Baseline)|Remission is a binary outcome response variable (Yes/No Inremission) defined as MADRS total score < 9 at visit month assessment post-baseline. The MADRS is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. The lower a score the less symptom severity is seen and in general it is accepted that a score between 0-6 is indicative of a normal/symptom-free individual; 7-19 is indicative of a patient with mild depression; 20-34 is indicative of a patient with moderate depression; and >34 is indicative of a patient with severe depression. Total number of patients in each group may be lower than ITT in a case of missing assessment data.|3-Month Through 60-Month (Post Baseline)|Intent-To-Treat (ITT) Population: VNS Therapy Population (n=489 (D-23=330 + D-21=159)) + (n= 276) TAU population||Percentage of Participants|||Number
722929|NCT00320372|Secondary|Time Until Recurrence (TUR) for Patients That Achieved Remission, Based on Montgomery Asberg Depression Rating Scale (MADRS)|"Recurrence based on MADRS is defined as first time attained MADRS total score ≥ 20 after achieving remission. Remission is a binary outcome response variable (Yes/No in-remission) defined as MADRS total score </= 9 at visit month assessment post-baseline. Duration of remission Computed as recorded date of the first recurrence/relapse (MADRS score >/= 20) minus the recorded date of first achieved remission (MADRS score </=9). Only a subpopulation that achieved remission will be included in the summary.
Time-to-event analyses were summarized using Kaplan-Meier curves. Patients who did not achieve recurrence at the end of the study were censored on the last visit date recorded. Additionally, patients who discontinued early were censored on last date of contact. Censored observations and confidence intervals for the estimated median times were calculated."|3-Month Through 60-Month (Post Baseline)|Intent-To-Treat (ITT) Population: VNS Therapy Population (n=489 (D-23=330 + D-21=159)) + (n= 276) TAU population||Months|Participants|95% Confidence Interval|Median
722930|NCT00320372|Primary|Montgomery Asberg Depression Rating Scale (MADRS)% Responders (>/= 50% Improvement From Baseline)|"Response Rate was computed and summarized as the proportion of patients that achieved ≥ 50% reduction from baseline in MADRS total score at each post-baseline visit. The MADRS is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. The lower a score the less symptom severity is seen. A patient was considered a “Responder” (Yes = 1) if achieved ≥ 50% reduction from baseline in MADRS total score at visit month assessment post-baseline. A “Non-Responder” (No = 0) was any patient who did not achieve ≥ 50% reduction from baseline in MADRS score at visit month assessment post-baseline.
Total number of patients in each group may be lower than ITT in a case of missing assessment data."|3-Month Through 60-Month (Post Baseline)|Intent-To-Treat (ITT) Population: VNS Therapy Population (n=489 (D-23=330 + D-21=159)) + (n= 276) TAU population||Percentage of Participants|||Number
722931|NCT00320385|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores at Week 4, Week 12, Week 16, Week 24, and Conclusion or Withdrawal From Study|Quality of Life (QOL) was assessed using the FACT-B questionnaire, which was a 37-item (27 general and 10 breast cancer-specific questions) self-reporting instrument consisting of 5 dimensions: physical-, social/family-, emotional-, functional-well being, and a breast cancer subscale. Higher scores on the FACT-B scales indicate a higher QOL; each ranging from 0 (not at all) to 4 (very much). The score is transformed for FACT-B and results in a total score ranging from 0 to 144.|Baseline, Week 4, Week 12, Week 16, Week 24, and conclusion or withdrawal from study (up to Week 108)|Safety Population: all randomized participants who received >=1 dose of investigational product. The Safety Population was based on the actual treatment received, if this differed from that to which the participant was randomized. Only participants whose overall item response rate was greater than 80% for the FACT-B total score were considered (n).||scores on a scale||Standard Deviation|Mean
722932|NCT00320385|Secondary|Time to Progression (TTP)|TTP was defined as the interval between the date of randomization and the earlier of the date of disease progression or death due to breast cancer. Because this outcome measure was confounded by death due to other causes and was similar to PFS, it was not analyzed.|Baseline to disease progression or death or 30 days after last dose (up to 216 weeks)|ITT Population|||||
722933|NCT00320385|Secondary|Duration of Response (DR)|DR was defined for the subset of participants who showed a confirmed CR or PR, as the time from the first documented evidence of CR or PR until the first documented sign of disease progression or death. Because of the low number of participants experiencing a confirmed response in both treatment arms, analysis for this outcome measure was not performed.|Time from first documented evidence of CR or PR until the first documented sign of disease progression or death or 30 days after last dose (up to 216 weeks)|ITT Population|||||
722934|NCT00320385|Secondary|Time to Response (TTR)|TTR was defined as the time from randomization until the first documented evidence of CR or PR (whichever status was recorded first). TTR could not be analyzed because too few participants experienced a confirmed CR or PR.|Baseline until first documented evidence of CR or PR or 30 days after last dose (up to 216 weeks)|ITT Population|||||
722935|NCT00320385|Secondary|Clinical Benefit Response (CBR)|CBR: percentage of participants with confirmed CR or PR or stable disease (SD) for at least 24 weeks according to RECIST criteria. CR: disappearance of all lesions (target and/or non-target). PR: at least a 30% decrease in the sum of the LD of target lesions taking as reference baseline sum LD, with non-target lesions not increased or absent. SD: neither had sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) in target lesions, taking as reference the smallest sum LD since treatment started; persistence of 1 or more non-target lesions.|Baseline to disease progression or death or discontinuation from study or 30 days after last dose (up to 216 weeks)|ITT Population||percentage of participants|||Number
722936|NCT00320385|Secondary|Overall Tumor Response (OR)|OR was defined as the percentage of participants experiencing either a confirmed complete response (CR) or a confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.0. CR was defined as the disappearance of all lesions (target and/or non-target). PR was defined as at least a 30% decrease in the sum of the longest dimensions (LD) of target lesions taking as a reference the baseline sum LD, with non-target lesions not increased or absent.|Baseline to disease progression or death or discontinuation from study or 30 days after last dose (up to 216 weeks)|ITT Population. Only participants with progesterone receptor status were considered for evaluation.||percentage of participants|||Number
722937|NCT00320385|Secondary|Overall Survival (OS)|OS was defined as the time from randomization until death due to any cause. For participants who did not die, OS was censored at the time of last contact.|Baseline to death or 30 days after last dose for the last participant (up to 216 weeks)|ITT Population. Only participants with progesterone receptor status were considered for evaluation.||weeks||95% Confidence Interval|Median
722938|NCT00320385|Primary|Progression-Free Survival (PFS)|PFS was defined as the time from randomization until the first documented sign of disease progression or death due to any cause.|Baseline to disease progression or death due to any cause or 30 days after last dose (up to 216 weeks)|Intent-to-Treat (ITT) Population: all randomized participants irrespective of whether or not they actually received study treatment. Only participants with progesterone receptor status were considered for evaluation.||weeks||95% Confidence Interval|Median
722939|NCT00320411|Secondary|Mean Terminal Deoxynucleotidyl Transferase Biotin-dUTP Nick End Labeling (TUNEL) H Score for All Participants|Intra-tumoral expression levels of TUNEL, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.|Tumor samples taken at baseline|Participants who provided enough tumor samples for this evaluation||units on a scale||Standard Deviation|Mean
722940|NCT00320411|Secondary|Mean Survivin H Score for All Participants|Intra-tumoral expression levels of Survivin, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.|Tumor samples taken at baseline|Participants who provided enough tumor samples for this evaluation||units on a scale||Standard Deviation|Mean
722941|NCT00320411|Secondary|Mean Insulin-like Growth Factor 1 Receptor (IGF1R) H Score for All Participants|Intra-tumoral expression levels of IGF1R, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.|Tumor samples taken at baseline|Participants who provided enough tumor samples for this evaluation||units on a scale||Standard Deviation|Mean
722942|NCT00320411|Secondary|Mean Heregulin H Score for All Participants|Intra-tumoral expression levels of Heregulin, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.|Tumor samples taken at baseline|Participants who provided enough tumor samples for this evaluation||units on a scale||Standard Deviation|Mean
722943|NCT00320411|Secondary|Mean Phosphorylated Extracellular Signal-regulated Kinase (p-ERK) H Score for All Participants|Intra-tumoral expression levels of ERK, a tumor tissue biomarker, were measured.using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.|Tumor samples taken at baseline|Participants who provided enough tumor samples for this evaluation||units on a scale||Standard Deviation|Mean
722944|NCT00320411|Secondary|Mean Epidermal Growth Factor Receptor 4 (ErbB4) H Score for All Participants|Intra-tumoral expression levels of ErbB4, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.|Tumor samples taken at baseline|Participants who provided enough tumor samples for this evaluation||units on a scale||Standard Deviation|Mean
722945|NCT00320411|Secondary|Mean Epidermal Growth Factor Receptor 3 (ErbB3) H Score for All Participants|Intra-tumoral expression levels of ErbB3, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.|Tumor samples taken at baseline|Participants who provided enough tumor samples for this evaluation||units on a scale||Standard Deviation|Mean
722946|NCT00320411|Secondary|Mean Bcl-2 H Score for All Participants|Intra-tumoral expression levels of Bcl-2, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.|Tumor samples taken at baseline|Participants who provided enough tumor samples for this evaluation||units on a scale||Standard Deviation|Mean
722947|NCT00320411|Secondary|Mean p-BAD H Score for All Participants|Intra-tumoral expression levels of BAD, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.|Tumor samples taken at baseline|Participants who provided enough tumor samples for this evaluation||units on a scale||Standard Deviation|Mean
723036|NCT00320788|Secondary|Percentage of Participants Who Gained at Least 15 Letters of Vision in the ETDRS Letter Score From Baseline at Week 12|Defined study baseline range of ETDRS Best Corrected Visual Acuity of: letter score of 73 to 25 (20/40 to 20/320) in the study eye; a higher score represents better functioning|At Week 12|FAS used for analysis, LOCF||percentage of participants|||Number
722948|NCT00320411|Secondary|Mean Phosphorylated 58 kDa Serine/Threonine Protein Kinase (p-AKT) H Score for All Participants|Intra-tumoral expression levels of AKT, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.|Tumor samples taken at baseline|Participants who provided enough tumor samples for this evaluation.||units on a scale||Standard Deviation|Mean
722949|NCT00320411|Secondary|Overall Survival|Overall survival was measured as the time between the start of dosing until death, regardless of cause.|Start of dosing to death; baseline and then followed every 4 weeks until death while on treatment. If alive at time of treatment termination, then followed every 12 weeks until death.|ITT Population||weeks||Inter-Quartile Range|Median
722950|NCT00320411|Secondary|6-month Progression Free Survival|The percentage of participants without progression or deaths at 6 months (24 weeks) after the start of dosing.|Baseline to Month 6 (Week 24)|ITT Population||percentage of participants|||Number
722951|NCT00320411|Secondary|4-month Progression Free Survival|The percentage of participants without progression or deaths at 4 months (16 weeks) after the start of dosing.|Baseline to Month 4 (Week 16)|ITT Population||percentage of participants|||Number
722952|NCT00320411|Secondary|Time to Response|Time to response was defined as the time from the start of treatment until first documented evidence of partial or complete tumor response (whichever status is recorded first).|Time at which all participants had been followed for at least 24 weeks; baseline and then followed every 4 weeks until disease progression (DP) or death. If treatment was terminated due to adverse event, then followed every 12 weeks until DP or death.|Participants in the ITT Population achieving a partial or complete response||Days||Full Range|Median
722953|NCT00320411|Secondary|Clinical Benefit|Clinical benefit was defined as the percentage of participants achieving complete response, partial response, and stable disease for more than 24 weeks.|Time at which all participants had been followed for at least 24 weeks; baseline and then followed every 4 weeks until disease progression (DP) or death. If treatment was terminated due to adverse events, then followed every 12 weeks until DP or death.|ITT Population||percentage of participants|||Number
722954|NCT00320411|Secondary|Time to Progression|Time to progression was defined as the time from the start of treatment until disease progression or death. Disease progression is defined as a 20% increase in the sum of the longest diameter of target lesions.|Baseline to disease progression or death; baseline and then followed every 4 weeks until disease progression or death. If treatment was terminated due to adverse events, then followed every 12 weeks until disease progression or death.|ITT Population||weeks||Inter-Quartile Range|Median
722955|NCT00320411|Secondary|Duration of Response|Duration of response is defined as the time between the point at which efficacy was noted until disease progression or death due to breast cancer.|First noted efficacy to disease progression; baseline and followed every 4 weeks until disease progression or death. If treatment was terminated due to adverse events, then followed every 12 weeks until disease progression is noted.|Participants who achieved defined efficacy||weeks||Inter-Quartile Range|Median
722956|NCT00320411|Primary|Overall Tumor Response|Tumor response was measured as the number of participants achieving either a complete response (CR; disappearance of all target lesions) or partial response (PR; 30% decrease in the sum of the longest diameter of target lesions) among all participants who received study treatment. Tumor response was evaluated as the best response in accordance with response evaluation criteria in solid tumors (RECIST). Progressive disease: a 20% increase in the sum of the longest diameter of target lesions. Stable disease: small changes that do not meet the above-mentioned criteria.|Baseline and then followed every 4 weeks until disease progression or death. If treatment was terminated due to adverse events, then followed every 12 weeks until disease progression is noted.|Intent-to-Treat (ITT) Population: all participants who had been registered and received at least one dose of the investigational product||participants|||Number
722957|NCT00320489|Secondary|Participants Discontinuing Because of an Adverse Event (AE) or Death||Baseline through 104 weeks|All data was analyzed on an intent-to-treat basis. An intent-to-treat analysis is an analysis of all randomized patients, with patients allocated to the treatment to which they were randomized even if a patient does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.||Participants|||Number
722958|NCT00320489|Secondary|Participants With Treatment-Emergent High Alanine Transaminase (ALT), Aspartate Transaminase (AST), and Total Bilirubin|Treatment-emergent (TE) high ALT is defined as a baseline value of <3 times the upper limit of normal (ULN) to >=3 times the ULN at endpoint. TE high AST is defined as a baseline value of <5 times the ULN to >=5 times the ULN at endpoint. TE high total bilirubin is defined as a baseline value of <2 times the ULN to >=2 times the ULN at endpoint. Hy's Rule is defined as ALT >=3 times the ULN and total bilirubin >=2 times the ULN.|Baseline through 104 Weeks|All data was analyzed on an intent-to-treat basis. An intent-to-treat analysis is an analysis of all randomized patients, with patients allocated to the treatment to which they were randomized even if a patient does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.||Participants|||Number
722959|NCT00320489|Secondary|Participants With Treatment-Emergent Abnormal High Prolactin at 104 Weeks|The prolactin reference Range is: Female: 2.0 - 29.0 nanograms per milliliter (ng/mL); Male: 2.0 - 20.0 ng/mL. A treatment-emergent abnormally high value is defined as a change from a value less than or equal to the high limit at all baseline visits to a value greater than the high limit at any time after baseline.|Baseline, 104 weeks|All data was analyzed on an intent-to-treat basis. An intent-to-treat analysis is an analysis of all randomized patients, with patients allocated to the treatment to which they were randomized even if a patient does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.||Participants|||Number
722969|NCT00320489|Secondary|Number of Participants With All-Cause Discontinuations (Excluding Sponsor Decision)|Number of participants who discontinued study participation for any reason (excluding sponsor decision).|Baseline through 104 weeks|All data was analyzed on an intent-to-treat basis. An intent-to-treat analysis is an analysis of all randomized patients, with patients allocated to the treatment to which they were randomized even if a patient does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.||Participants|||Number
722960|NCT00320489|Secondary|Participants With Normal to High Fasting Glucose, Fasting Total Cholesterol, and Fasting Triglycerides|Normal to high fasting glucose = <100 milligrams per deciliter (mg/dL) baseline; >=126 mg/dL any time post baseline (or endpoint). Normal to high fasting total cholesterol =<200 mg/dL baseline; >=240 mg/dL any time post baseline or endpoint. Fasting triglycerides <150 mg/dL baseline; >=200 mg/dL and <500 mg/dL any time post baseline or endpoint.|Baseline through 104 weeks|All data was analyzed on an intent-to-treat basis. An intent-to-treat analysis is an analysis of all randomized patients, with patients allocated to the treatment to which they were randomized even if a patient does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.||Participants|||Number
722961|NCT00320489|Secondary|Participants With Potentially Clinically Significant (PCS) Weight Gain at 104 Weeks|PCS weight gain is defined as a >=7% increase in weight from baseline at 104 weeks.|Baseline, 104 weeks|All data was analyzed on an intent-to-treat basis. An intent-to-treat analysis is an analysis of all randomized patients, with patients allocated to the treatment to which they were randomized even if a patient does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.||Participants|||Number
722962|NCT00320489|Secondary|Change From Baseline in Weight at 104 Weeks||Baseline, 104 weeks|All data was analyzed on an intent-to-treat basis. An intent-to-treat analysis is an analysis of all randomized patients, with patients allocated to the treatment to which they were randomized even if a patient does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.||Kilograms||Standard Deviation|Mean
722963|NCT00320489|Secondary|Resource Utilization: Number of Outpatient Surgeries During the Study, 24 Months After Randomization|Number of outpatient surgeries during the study, post-baseline through 104 weeks.|Baseline through 104 Weeks|All data was analyzed on an intent-to-treat basis. An intent-to-treat analysis is an analysis of all randomized patients, with patients allocated to the treatment to which they were randomized even if a patient does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.||Surgeries||Standard Deviation|Mean
722964|NCT00320489|Secondary|Change From Baseline in Brief Psychiatric Rating Scale (BPRS) Total Score at 104 Weeks|BPRS is an 18-item clinician-administered scale used to assess the degree of severity of a subject's general psychopathological symptoms. For this study, the BPRS total score was derived from 18 PANSS questions. To calculate the score, the score of the 18 questions was added then 18 was subtracted from the total. As an example, if a subject had a score=1 (absent) on all 18 items, the resulting total=zero. Responses range from 0 (absent) to 6 (extremely severe); the Total Score range is 0-108.|Baseline, 104 weeks|All data analyzed on ITT basis. ITT analysis: analysis of all randomized patients with patients allocated to the treatment to which they were randomized even if they did not take assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Assessment of baseline-to-endpoint change based on MMRM methodology.||Units on a scale||Standard Error|Least Squares Mean
722965|NCT00320489|Secondary|Number of Participants Experiencing Relapse|Relapse is defined as any one of the following: 1) hospitalization for symptoms related to schizophrenia; 2) an increase of 25% from baseline in the total score on the PANSS (if the baseline score was >40), or an increase of 10 points (if baseline score was <=40) and >=1-point increase from baseline score on the CGI-S score, provided that the increase results in a CGI-S score >=4; 3) deliberate self-injury or injury to others that is deemed clinically to be associated with worsening of psychosis; 4) discontinuation from the study because of worsening of psychosis.|Baseline through 104 weeks|All data was analyzed on an intent-to-treat basis. An intent-to-treat analysis is an analysis of all randomized patients, with patients allocated to the treatment to which they were randomized even if a patient does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.||Participants|||Number
722966|NCT00320489|Secondary|Median Time to Relapse|Relapse is defined as any 1 of the following: 1) hospitalization for symptoms related to schizophrenia; 2) increase of 25% from baseline in PANSS total score (range:30-210) (if baseline score was >40) or increase of 10 points (if baseline score was ≤40), and ≥1-point increase from baseline on CGI-S score (range:1-7), provided that increase results in CGI-S ≥4; 3) deliberate self-injury or injury to others deemed clinically to be associated with worsening of psychosis; 4) discontinuation from the study because of worsening of psychosis. On PANSS and CGI-S higher scores indicate greater illness.|Baseline to time of relapse (up to 104 weeks)|All data was analyzed on an intent-to-treat basis. An intent-to-treat analysis is an analysis of all randomized patients, with patients allocated to the treatment to which they were randomized even if a patient does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.||Days||Inter-Quartile Range|Median
722967|NCT00320489|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total and Subscale Scores at 104 Weeks|Assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210.|Baseline, 104 weeks|All data analyzed on ITT basis. ITT analysis: analysis of all randomized patients with patients allocated to the treatment to which they were randomized even if they did not take assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Assessment of baseline-to-endpoint change based on MMRM methodology.||Units on a Scale||Standard Error|Least Squares Mean
722968|NCT00320489|Secondary|Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Scale Scores at 104 Weeks|Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Baseline, 104 weeks|All data analyzed on ITT basis. ITT analysis: analysis of all randomized patients with patients allocated to the treatment to which they were randomized even if they did not take assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Assessment of baseline-to-endpoint change based on MMRM methodology.||Units on a Scale||Standard Error|Least Squares Mean
723037|NCT00320788|Secondary|Mean Change in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) From Baseline at Week 12|Defined study baseline range of ETDRS Best Corrected Visual Acuity of: letter score of 73 to 25 (20/40 to 20/320) in the study eye; a higher score represents better functioning|Baseline and at week 12|FAS used for analysis, LOCF||letters read||Standard Deviation|Mean
722970|NCT00320489|Secondary|Patient Attitude Toward Treatment Using the Drug Attitude Inventory (DAI) Scale Total Score at 104 Weeks|Self-rated scale which measures patient's subjective feelings about taking medications. Each of 10 items is rated as true or false. For items 1, 3, 4, 6, 7, 9, and 10, true is scored as 1; false is scored as 0. For items 2, 5, and 8, true is scored as 0; false is scored as 1. Possible total scores range from 0-10. A subject who answers all 10 questions false will have a score of 3; a subject who answers all 10 questions true will have a score of 7. For 7 out of 10 questions, false is represented by 0, the other 3 questions false is represented by a value=1.|104 weeks|All data analyzed on an ITT basis. ITT analysis: analysis of all randomized patients, with patients allocated to the treatment to which they were randomized even if they did not take assigned treatment, did not receive correct treatment, or otherwise did not follow the protocol. Assessment of baseline-to-endpoint change based on MMRM methodology.||Units on a Scale||Standard Error|Least Squares Mean
722971|NCT00320489|Secondary|Patient Satisfaction With Medication Questionnaire-Modified (PSMQ) at 104 Weeks (All Items)|Self-rated scale which measures patient's level of satisfaction with current antipsychotic medication. Consists of 3 items assessing satisfaction with current study medication (scored from 1-'very dissatisfied' to 5-'very satisfied'), preference comparing current study medication versus previous medications (scored from 1-'much prefer previous medication' to 5-'much prefer study medication'), and side effects of current study medication compared with previous medications (scored from 1-'much less side effects' to 5-'much more side effects'). Range of possible scores is 3-15.|104 weeks|All data analyzed on an ITT basis. ITT analysis: analysis of all randomized patients, with patients allocated to the treatment to which they were randomized even if they did not take assigned treatment, did not receive correct treatment, or otherwise did not follow the protocol. Assessment of baseline-to-endpoint change based on MMRM methodology.||Units on a Scale||Standard Error|Least Squares Mean
722972|NCT00320489|Secondary|Change From Baseline in Schizophrenia Objective Functioning Instrument (SOFI) Global Score at 104 Weeks|Interviewer-rated 49-item scale used to assess 4 functional domains in patients with schizophrenia : 1) living situation, 2) instrumental activities of daily living, 3) productive activities and role functioning, and 4) social/recreational functioning. Possible responses and scoring vary by item and by domain, with higher scores representing better functioning. Range of possible scores is 1-100. LS Mean values were adjusted for investigator and treatment at baseline, and the change values were also adjusted for baseline.|Baseline, 104 weeks|All data analyzed on ITT basis. ITT analysis: analysis of all randomized patients with patients allocated to the treatment to which they were randomized even if they did not take assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Assessment of baseline-to-endpoint change based on MMRM methodology.||Units on a Scale||Standard Error|Least Squares Mean
722973|NCT00320489|Secondary|Change From Baseline in Working Alliance Inventory (WAI) Total Score at 104 Weeks|Self-rated scale assessing patients' level of alliance with their therapist, including agreement on goals, tasks, and emotional bond. Each of 12 items is rated from 1 ('never') to 7 ('always'), with higher scores indicating greater alliance. Total Scores range from 12-84. LS Mean values were adjusted for investigator and treatment at baseline, and the change values were also adjusted for baseline.|Baseline, 104 weeks|All data analyzed on ITT basis. ITT analysis: analysis of all randomized patients with patients allocated to the treatment to which they were randomized even if they did not take assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Assessment of baseline-to-endpoint change based on MMRM methodology.||Units on a Scale||Standard Error|Least Squares Mean
722974|NCT00320489|Secondary|Change From Baseline in Scale to Assess Unawareness of Mental Disorder (SUMD) Total Score at 104 Weeks|Interviewer-rated scale that assesses patients' awareness of and insight into their illness. SUMD can either be based on 4 items or 5 items. Items 1 through 4 are rated from 1 (aware) to 5 (unaware); item 5 assesses correct attribution of symptoms to a mental disorder and is rated from 1 (symptoms correctly attributed) to 5 (symptoms incorrectly attributed). Total Scores for Items (1-4) range from 4 to 20 and Total Scores for Items (1-5) range from 5 to 25. LS Mean values were adjusted for investigator and treatment at baseline, and the change values were also adjusted for baseline.|Baseline, 104 weeks|All data analyzed on ITT basis. ITT analysis: analysis of all randomized patients with patients allocated to the treatment to which they were randomized even if they did not take assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Assessment of baseline-to-endpoint change based on MMRM methodology.||Units on a Scale||Standard Error|Least Squares Mean
722975|NCT00320489|Secondary|Number of Hospitalization Days|Mean - calculated based on total number of hospitalization days per patient within reporting interval.|Baseline through 104 weeks|All data was analyzed on an intent-to-treat basis. An intent-to-treat analysis is an analysis of all randomized patients, with patients allocated to the treatment to which they were randomized even if a patient does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.||Days||Standard Deviation|Mean
722976|NCT00320489|Secondary|Resource Utilization: Days of Unpaid Care, Days of Workdays Missed, Days of Paid Care Per Week During the Study|Number of days of unpaid care, number of days of workdays missed, number of days of paid care per week during the study, post-baseline through 104 weeks.|Baseline through 104 weeks|All data was analyzed on an intent-to-treat basis. An intent-to-treat analysis is an analysis of all randomized patients, with patients allocated to the treatment to which they were randomized even if a patient does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.||Days||Standard Deviation|Mean
722977|NCT00320489|Secondary|Resource Utilization: Number of Outpatient Physician Visits During the Study|Number of outpatient physician visits during the study, post-baseline through 104 weeks.|Baseline through 104 weeks|All data was analyzed on an intent-to-treat basis. An intent-to-treat analysis is an analysis of all randomized patients, with patients allocated to the treatment to which they were randomized even if a patient does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.||Outpatient physician visits||Standard Deviation|Mean
722987|NCT00320528|Secondary|Change From Baseline to 12 Week Endpoint in Conners' Teacher Rating Scale-Revised: Short Form (CTRS-R:S)|A 28-item rating scale (0 [not at all/never] to 3 [very much true/very often]) completed by the teacher to assess problem behaviors related to ADHD. Subscale total scores range from 0 to 15 for Oppositional and Cognitive Problems, 0 to 21 for Hyperactivity, and 0 to 36 for ADHD Index.|Baseline, 12 Weeks|Number of patients with baseline and at least one nonmissing post-baseline measurement.||units on a scale||95% Confidence Interval|Mean
722978|NCT00320489|Secondary|Change From Baseline in Burden Assessment Scale (BAS) Total Score at 104 Weeks|"Self-rated scale completed by patient's caregiver which measures level of burden placed on the caregiver by caring for the patient. Each of 19 items is rated on a scale from 0 (no impact) to 3 (high negative impact). Total Score range is 0-57. If any of the 19 questions were answered not applicable, then a Total Score of 9 was entered. LS Mean values were adjusted for investigator and treatment at baseline, and the change values were also adjusted for baseline."|Baseline, 104 weeks|All data analyzed on ITT basis. ITT analysis: analysis of all randomized patients with patients allocated to the treatment to which they were randomized even if they did not take assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Assessment of baseline-to-endpoint change based on MMRM methodology.||Units on a Scale||Standard Error|Least Squares Mean
722979|NCT00320489|Secondary|Change From Baseline in Overall Health Status Assessment Using the EuroQol: 5 Dimensions Questionnaire (EQ-5D) at 104 Weeks|Generic, multidimensional, health-related, quality-of-life instrument. Overall health status is self-reported using a visual analogue scale marked on a scale of 0 to 100 with 0 representing worst imaginable health state and 100 representing best imaginable health state. LS Mean values were adjusted for investigator and treatment at baseline; change values were also adjusted for baseline.|Baseline, 104 weeks|All data analyzed on ITT basis. ITT analysis: analysis of all randomized patients with patients allocated to the treatment to which they were randomized even if they did not take assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Assessment of baseline-to-endpoint change based on MMRM methodology.||Units on a Scale||Standard Error|Least Squares Mean
722980|NCT00320489|Secondary|Change From Baseline in 36-Item Short Form Health Survey (SF-36) at 104 Weeks, All Domains and Summary Scores|SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains. Domains and scores: general health=5-25; physical functioning=10-30; role-physical=4-8; role-emotional=3-6; social functioning=2-10; bodily pain=2-11; vitality=4-24; mental health=5-30. There are 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). MCS and PCS scores=0-100 (higher scores indicate better health status). LS Mean values were adjusted for investigator and treatment at baseline; change values were also adjusted for baseline.|Baseline, 104 weeks|All data analyzed on ITT basis. ITT analysis: analysis of all randomized patients with patients allocated to the treatment to which they were randomized even if they did not take assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Assessment of baseline-to-endpoint change based on MMRM methodology.||Units on a Scale||Standard Error|Least Squares Mean
722981|NCT00320489|Secondary|Change From Baseline in Heinrich-Carpenter Quality of Life in Schizophrenia Scale (QLS) Total Score at 104 Weeks|Interviewer-rated scale which measures the impact of negative symptoms on occupational, social, and psychological functioning in patients with schizophrenia or schizoaffective disorder. Each of 21 items is rated on a scale from 0 (severely impaired functioning) to 6 (normal or adequate functioning). Total score range is 0-126. Least Squares Mean (LS Mean) values were adjusted for investigator and treatment at baseline, and the change values were also adjusted for baseline.|Baseline, 104 weeks|All data were analyzed on ITT basis. ITT analysis: analysis of all randomized patients allocated to the randomized treatment even if they did not take assigned treatment, did not receive correct treatment, or otherwise did not follow the protocol. Assessment of baseline-to-endpoint change based on mixed-model repeated measures (MMRM) methodology.||Units on a Scale||Standard Error|Least Squares Mean
722982|NCT00320489|Primary|Median Time to Discontinuation for Any Reason (Excluding Sponsor Decision)||Baseline up to 104 weeks|All data was analyzed on an intent-to-treat (ITT) basis. An ITT analysis is an analysis of all randomized patients, with patients allocated to the treatment to which they were randomized even if a patient does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.||Days||Inter-Quartile Range|Median
722983|NCT00320515|Secondary|Overall Survival|Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.|baseline to date of death from any cause (Survival follow-up were performed every 2 cycles during therapy and approximately every 3 months during post-therapy until death or up to 12 months after enrollment)|All enrolled participants who received at least one dose of study drug and had measurable disease at baseline. Thirty-five participants were censored.||months||95% Confidence Interval|Median
722984|NCT00320515|Secondary|Progression Free Survival|The period from study entry until disease progression or death on study, whichever occurred first.|baseline to measured progressive disease or death (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until disease progression, or up to 12 months after enrollment)|All enrolled participants who received at least one dose of study drug and had measureable disease at baseline. Twenty-six participants were censored.||months||95% Confidence Interval|Median
722985|NCT00320515|Secondary|Duration of Response|The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.|time of response to progressive disease or death (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until disease progression, or up to 12 months after enrollment)|All enrolled participants who received at least one dose of study drug, had measureable disease at baseline, and had confirmed complete or partial responses. There were 16 patients qualified for the analysis of duration of response. Twelve participants were censored.||months||95% Confidence Interval|Median
722986|NCT00320515|Primary|Objective Best Tumor Response|Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.|baseline to measured progressive disease (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until disease progression, or up to 12 months after enrollment)|All enrolled participants who received at least one dose of study drug. One participant was excluded from analysis because of no measurable disease at baseline.||participants|||Number
723033|NCT00320749|Primary|Maximum Tolerated Dose (MTD)|MTD will be the dose at which 1 or fewer patients (≤ 1/6) experiences a DLT during the first or second cycle with the next higher dose having at least 2/3 or 2/6 patients experiencing Dose Limiting Toxicities (DLT).|Weekly up to 24 weeks|||mg/m^2|||Number
722988|NCT00320528|Secondary|Change From Baseline to 12 Week Endpoint in Child Symptom Inventory-4: Parent Checklist (CSI-4)|The CSI-4 contains 97 items that screen for 15 emotional and behavioral disorders in children between 5 and 12 years old. Item score range:0 (no symptoms) to 3 (maximum impairment). Categories: A=ADHD (0-54); B=Conduct (0-60); C=Oppositional Defiant (0-24); D=Generalized Anxiety (0-18); E=Specific Phobia/Panic Attack/Obsessions/Compulsions/Somatization (0-30); F=Social Phobia (0-6); G=Separation Anxiety (0-24); H=Schizoid Personality (0-9); I=Schizophrenia (0-6); J=Enuresis (0-18).|Baseline, 12 Weeks|Number of child patients with baseline and at least one nonmissing post-baseline measurement.||units on a scale||Standard Deviation|Mean
722989|NCT00320528|Secondary|Change From Baseline to 12 Week Endpoint in Adolescent Symptom Inventory-4: Parent Checklist (ASI-4)|Parent-completed ASI-4 contains 120 items on 18 emotional and behavioral disorders in adolescents (12-18 years old). Item score range:0 (no symptoms) to 3 (maximum impairment). Categories: A=ADHD (0-54); B=Conduct (0-60); C=Oppositional Defiant (0-24); D=Generalized Anxiety (0-18); E=Specific Phobia/Panic Attack/Obsessions/Compulsions/Somatization (0-30); F=Social Phobia (0-6); G=Separation Anxiety (0-24); H=Schizoid Personality (0-9); I=Schizophrenia (0-6); J=Enuresis (0-18); K=Major Depressive (0-42); L=Bipolar (0-27); M=Anorexia (0-12); N=Bulimia (0-12); O=Substance Abuse (0-18).|Baseline, 12 Weeks|Number of adolescent patients with baseline and at least one nonmissing post-baseline measurement.||units on a scale||Standard Deviation|Mean
722990|NCT00320528|Secondary|Change From Baseline to 12 Week Endpoint in SNAP-IV Oppositional Scale|Items are included from the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for Oppositional Defiant Disorder. The SNAP-IV is based on a 0 (not at all) to 3 (very much) rating scale. Total subscale scores range from 0 to 24.|Baseline, 12 Weeks|Number of patients with baseline and at least one nonmissing post-baseline measurement.||units on a scale||95% Confidence Interval|Mean
722991|NCT00320528|Secondary|Change From Baseline to 12 Week Endpoint in Children's Depression Rating Scale-Revised (CDRS-R)|Measures presence and severity of depression. Consists of 17 items scored on a 1-5 or 1-7 scale. A rating of 1 indicates normal, thus the minimum score is 17. The maximum score is 113. In general, scores below 20 indicate an absence of depression; scores of 20 or 30 indicate borderline depression; scores of 40 to 60 indicate moderate depression.|Baseline, 12 Weeks|Number of patients with baseline and at least one nonmissing post-baseline measurement.||units on a scale||95% Confidence Interval|Mean
722992|NCT00320528|Secondary|Change From Baseline to 12 Week Endpoint in Pediatric Anxiety Rating Scale (PARS)|The Pediatric Anxiety Rating Scale (PARS) is used to rate the severity of anxiety in children and adolescents, ages 6 to 17 years. The total score for the PARS is derived by summing 5 of the 7 severity/impairment/interference items (2,3,5,6,7). The total score ranges from 0 (none) to 25 (extreme severity). Items 1 (overall number of anxiety symptoms) and 4 (overall severity of physical symptoms) are not included in the total score calculation.|Baseline, 12 Weeks|Number of patients with baseline and at least one nonmissing post-baseline measurement.||units on a scale||95% Confidence Interval|Mean
722993|NCT00320528|Secondary|Change From Baseline to 12 Week Endpoint in CHIP-CE Satisfaction, Comfort, Resilience and Risk Avoidance Domains|Parent-rated assessment of a child’s health status and level of functioning. It consists of 76 items. The majority of items assess frequency of activities or feelings using a five-point response format (for example, ‘how good is your child at making friends?’ 1=never, 5=always). Standard scores (t-value) were established, with all domains having a mean score of 50 and standard deviation of 10. Satisfaction range=-25.7 to 66.3; Comfort=-28.6 to 67.2; Resilience=-36.3 to 71.8; Risk Avoidance=-23.5 to 62.5. Higher scores mean greater health or level of functioning in that domain.|Baseline, 12 Weeks|Number of patients with baseline and at least one nonmissing post-baseline measurement.||T-Score||95% Confidence Interval|Mean
722994|NCT00320528|Secondary|Change From Baseline to 12 Week Endpoint in Clinical Global Impressions-ADHD-Severity (CGI-ADHD-S)|Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).|Baseline, 12 Weeks|Number of patients with baseline and at least one nonmissing post-baseline measurement.||units on a scale||95% Confidence Interval|Mean
722995|NCT00320528|Secondary|Change From Baseline to 12 Week Endpoint in the Attention-Deficit/Hyperactivity Disorder (ADHD) Subscales of 18-Item Swanson, Nolan and Pelham Rating Scale (SNAP-IV)|Items from the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for ADHD are included for the two subsets of symptoms: inattention (items #1-#9: total score=0-27) and hyperactivity/impulsivity (items #11-#19: total score=0-27). The SNAP-IV is based on a 0 (not at all) to 3 (very much) rating scale. Total combined type (inattention plus hyperactivity/impulsivity) subscale scores range from 0 to 54.|Baseline, 12 Weeks|Number of patients with baseline and at least one nonmissing post-baseline measurement.||units on a scale||95% Confidence Interval|Mean
722996|NCT00320528|Primary|Change From Baseline to 12 Week Endpoint in Child Health and Illness Profile - Child Edition (CHIP-CE), Achievement Domain|Parent-rated assessment of a child’s health status and level of functioning. It consists of 76 items. The majority of items assess frequency of activities or feelings using a five-point response format (for example, ‘how good is your child at making friends?’ 1=never, 5=always). Standard scores (t-value) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Standard scores are expressed in standard deviation units. Achievement Domain Range = -3.1 to 67.7. Higher scores mean greater health or level of functioning in achievement.|Baseline, 12 Weeks|Number of patients with baseline and at least one nonmissing post-baseline measurement.||T-Score||95% Confidence Interval|Mean
722997|NCT00320541|Secondary|Trial Outcome Index-Breast (TOI-B): Change From Baseline to End of Therapy|The TOI-B represents the total of the subscales PWB,FWB, and BCS. Total TOI-B scores range from 0 to 92, with higher scores representing better HR-QOL. Minimally important differences estimates obtained for TOI is 5-6 points. FACT-B was assessed at baseline (prior to start of Cycle 1 [Day 1]), then prior to start of each subsequent cycle (approximately every 4 weeks) during therapy, through 30-day post therapy follow-up.|Baseline through 30 days post therapy follow-up (up to 35 months)|Last Observation Carried Forward (LOCF) for all ITT patients with valid baseline and at least one valid post-baseline assessment||units on a scale||Standard Deviation|Mean
723034|NCT00320788|Post-Hoc|Mean Change in BCVA as Measured by ETDRS From Baseline at Week 16|Defined study baseline range of ETDRS Best Corrected Visual Acuity of: letter score of 73 to 25 (20/40 to 20/320) in the study eye; a higher score represents better functioning|Baseline and at Week 16|FAS used for analysis, LOCF||letters read||Standard Deviation|Mean
722998|NCT00320541|Secondary|Breast Cancer Subscale (BCS): Change From Baseline to End of Therapy|The BCS subscale of FACT-B measures additional concerns of breast cancer . Total BCS scores range from 0 to 36, with higher scores representing better HR-QOL. Minimally important differences estimates obtained for BCS is 2-3 points. FACT-B was assessed at baseline (prior to start of Cycle 1 [Day 1]), then prior to start of each subsequent cycle (approximately every 4 weeks) during therapy, through 30-day post therapy follow-up.|Baseline through 30 days post therapy follow-up (up to 35 months)|Last Observation Carried Forward (LOCF) for all ITT patients with valid baseline and at least one valid post-baseline assessment||units on a scale||Standard Deviation|Mean
722999|NCT00320541|Secondary|Functional Well Being (FWB) Subscale: Change From Baseline to End of Therapy|The FWB subscale of FACT-B measures functional well-being. Total FWB scores range from 0 to 28, with higher scores representing better HR-QOL. FACT-B was assessed at baseline (prior to start of Cycle 1 [Day 1]), then prior to start of each subsequent cycle (approximately every 4 weeks) during therapy, through 30-day post therapy follow-up.|Baseline through 30 days post therapy follow-up (up to 35 months)|Last Observation Carried Forward (LOCF) for all ITT patients with valid baseline and at least one valid post-baseline assessment||units on a scale||Standard Deviation|Mean
723000|NCT00320541|Secondary|Emotional Well Being (EWB) Subscale: Change From Baseline to End of Therapy|The EWB subscale of FACT-B measures emotional well-being. Total EWB scores range from 0 to 24, with higher scores representing better HR-QOL. FACT-B was assessed at baseline (prior to start of Cycle 1 [Day 1]), then prior to start of each subsequent cycle (approximately every 4 weeks) during therapy, through 30-day post therapy follow-up.|Baseline through 30 days post therapy follow-up (up to 35 months)|Last Observation Carried Forward (LOCF) for all ITT patients with valid baseline and at least one valid post-baseline assessment||units on a scale||Standard Deviation|Mean
723001|NCT00320541|Secondary|Social/Family Well Being (SFWB) Subscale: Change From Baseline to End of Therapy|The SFWB subscale of FACT-B measures social/family well-being. Total SFWB scores range from 0 to 28, with higher scores representing better HR-QOL. FACT-B was assessed at baseline (prior to start of Cycle 1 [Day 1]), then prior to start of each subsequent cycle (approximately every 4 weeks) during therapy, through 30-day post therapy follow-up.|Baseline through 30 days post therapy follow-up (up to 35 months)|Last Observation Carried Forward (LOCF) for all ITT patients with valid baseline and at least one valid post-baseline assessment||units on a scale||Standard Deviation|Mean
723002|NCT00320541|Secondary|Physical Well Being (PWB) Subscale: Change From Baseline to End of Therapy|The PWB subscale of FACT-B measures physical well-being. Total PWB scores range from 0 to 28, with higher scores representing better HR-QOL. FACT-B was assessed at baseline (prior to start of Cycle 1 [Day 1]), then prior to start of each subsequent cycle (approximately every 4 weeks) during therapy, through 30-day post therapy follow-up.|Baseline through 30 days post therapy follow-up (up to 35 months)|Last Observation Carried Forward (LOCF) for all ITT patients with valid baseline and at least one valid post-baseline assessment||units on a scale||Standard Deviation|Mean
723003|NCT00320541|Secondary|Total Functional Assessment of Cancer Therapy -Breast (FACT-B): Change From Baseline to End of Therapy|FACT-B measures the following domains of health-related quality of life (HR-QL): physical well-being (PWB), social/family well-being (SFWB), emotional well-being (EWB), functional well-being (FWB), & additional concerns of breast cancer (BCS). Total FACT-B scores range from 0-144, with higher scores representing better HR-QOL. Minimally important differences estimates obtained for FACT-B is 7-8 points. FACT-B was assessed at baseline (prior to start of Cycle 1 [Day 1]), prior to start of each subsequent cycle (approximately every 4 weeks) during therapy, through 30-day post therapy follow-up.|Baseline through 30 days post therapy follow-up (up to 35 months)|Last Observation Carried Forward (LOCF) for all ITT patients with valid baseline and at least one valid post-baseline assessment||units on a scale||Standard Deviation|Mean
723004|NCT00320541|Secondary|Overall Survival|Overall survival was measured from date of randomization to date of death from any cause. For participants not known to have died as of data-inclusion cut-off date, overall survival duration was censored at date of last study visit prior to the data cut-off date.|baseline to death from any cause (up to 35 months)|Intent-To-Treat (ITT) population=all randomized participants, eligible & ineligible. Number of participants with events: PB=35; PB+G=34. Censored participants: PB=59;PB+G=59.||months||Full Range|Median
723005|NCT00320541|Secondary|Progression-free Survival (PFS)|PFS was measured from date of randomization to first date of disease progression or death from any cause. For participants not known to have died or had disease progression as of data-inclusion cut-off date, PFS duration was censored at date of last study visit prior to data-inclusion cut-off date.|baseline to measured progressive disease or death up to 35 months (tumor assessments were performed every 2 cycles during study therapy; every 2 months during post-therapy until disease progression or new anticancer treatment initiated)|ITT population=all randomized participants, eligible & ineligible. Participants with events: PB=74; PB+G=72. Censored participants: PB=20 PB+G=21.||months||Full Range|Median
723006|NCT00320541|Primary|Overall Response Rate (ORR)|Response defined per Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. ORR was defined as the proportion of participants who achieved a best response of either CR or PR. ORR=number of participants with CR or PR/number of participants qualified for tumor response analysis (per-protocol population).|baseline & every 2 cycles (approximately 8 weeks) of treatment to measured progressive disease (PD) & post-therapy until PD or other therapy initiated (up to 35 months)|Per-protocol population included intent-to-treat participants who met the following criteria: histological or cytological breast cancer diagnosis; baseline presence of measurable disease per RECIST; at least 1 dose of study drug; no current systemic anti-tumor therapy except protocol-specified therapy. One PB+G participant did not qualify.||proportion of responders||95% Confidence Interval|Mean
723007|NCT00320593|Secondary|Excellent Spectacle Compliance|Spectacle compliance was assessed on a five-point Likert scale: always, 5; often, 4; sometimes, 3; rarely, 2; and never, 1. Excellent compliance indicates that for the specified period (during school, after school, on weekends), spectacles were estimated at all visits to have been worn either always or often.|Baseline to 3 years|The analysis followed the intent-to-treat principle. Two patients had no compliance data because they had no follow-up visits (one single vision lenses, and one progressive-addition lenses).||percent of participants|||Number
723008|NCT00320593|Secondary|Mean Change in Spherical Equivalent Refractive Error From Baseline to 2 Years|Measured in diopters (D) using cycloplegic refraction sphere (amount of myopia) and cylinder (amount of astigmatism at an angle (axis)). Spherical equivalent (SE) is defined as the sphere plus 1/2 the cylinder. For baseline and 2 years, a SE was calculated for each eye for each of the five trials of cycloplegic autorefraction; the median for each eye was averaged to obtain the SE used for analysis. Change was calculated as SE at baseline minus SE at 2 years. A negative value indicates that the myopia worsened; a positive value indicates that it improved.|Baseline to 2 years|The analysis followed the intent-to-treat principle||diopters||Standard Deviation|Mean
723009|NCT00320593|Secondary|Mean Change in Spherical Equivalent Refractive Error From Baseline to 1 Year|Measured in diopters (D) using cycloplegic refraction sphere (amount of myopia) and cylinder (amount of astigmatism at an angle (axis)). Spherical equivalent (SE) is defined as the sphere plus 1/2 the cylinder. For baseline and 1 year, a SE was calculated for each eye for each of the five trials of cycloplegic autorefraction; the median for each eye was averaged to obtain the SE used for analysis. Change was calculated as SE at baseline minus SE at 1 year. A negative value indicates that the myopia worsened; a positive value indicates that it improved.|Baseline to 1 year|The analysis followed the intent-to-treat principle.||diopters||Standard Deviation|Mean
723010|NCT00320593|Secondary|Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics|Measured in diopters (D) using cycloplegic refraction sphere (amount of myopia) and cylinder (amount of astigmatism at an angle (axis)). Spherical equivalent (SE) is defined as the sphere plus 1/2 the cylinder. For baseline and 3 years, a SE was calculated for each eye for each of the five trials of cycloplegic autorefraction; the median for each eye was averaged to obtain the SE used for analysis. Change was calculated as SE at baseline minus SE at 3 years. A negative value indicates that the myopia worsened; a positive value indicates that it improved.|Baseline to 3 years|The analysis followed the intent-to-treat principle.||diopters||Standard Deviation|Mean
723011|NCT00320593|Secondary|Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics|Measured in diopters (D) using cycloplegic refraction sphere (amount of myopia) and cylinder (amount of astigmatism at an angle (axis)). Spherical equivalent (SE) is defined as the sphere plus 1/2 the cylinder. For baseline and 3 years, a SE was calculated for each eye for each of the five trials of cycloplegic autorefraction; the median for each eye was averaged to obtain the SE used for analysis. Change was calculated as SE at baseline minus SE at 3 years. A negative value indicates that the myopia worsened; a positive value indicates that it improved.|Baseline to 3 years|The analysis followed the intent-to-treat principle.||participants|||Number
723012|NCT00320593|Primary|Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years|Measured in diopters (D) using cycloplegic refraction sphere (amount of myopia) and cylinder (amount of astigmatism at an angle (axis)). Spherical equivalent (SE) is defined as the sphere plus 1/2 the cylinder. For baseline and each time point, a SE was calculated for each eye for each of the five trials of cycloplegic autorefraction; the median for each eye was averaged to obtain the SE used for analysis. Change was calculated as SE at baseline minus SE at 3 years. A negative value indicates that the myopia worsened; a positive value indicates that it improved.|3 years|All analyses followed the intent-to-treat principle. The Monte Carlo Markov Chain (MCMC) method of multiple imputation was used to impute data for subjects who did not complete the 3-year visit.||diopters||Standard Deviation|Mean
723013|NCT00320593|Secondary|Mean Spherical Equivalent Refractive Error at 3 Years|Measured in diopters (D) using cycloplegic refraction sphere (amount of myopia) and cylinder (amount of astigmatism at an angle (axis)). Spherical equivalent (SE) is defined as the sphere plus 1/2 the cylinder. A SE was calculated for each eye for each of the five trials of cycloplegic autorefraction, and the median for each eye was averaged to obtain the SE used for analysis.|3 years|The analysis followed the intent-to-treat principle.||diopters||Standard Deviation|Mean
723014|NCT00320593|Primary|Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years|Measured in diopters (D) using cycloplegic refraction sphere (amount of myopia) and cylinder (amount of astigmatism at an angle (axis)). Spherical equivalent (SE) is the sphere plus 1/2 the cylinder. For baseline and each time point, a SE was calculated for each eye for each of the five trials of cycloplegic autorefraction; the median for each eye was averaged to obtain the SE used for analysis. Change was calculated as SE at baseline minus SE at 3 years. A negative value indicates that the myopia worsened; a positive value indicates that it improved.|Baseline to 3 years|The analysis followed the intent-to-treat principle.||participants|||Number
723015|NCT00320593|Secondary|Distribution of Spherical Equivalent Refractive Error at 3 Years|Measured in diopters (D) using cycloplegic refraction sphere (amount of myopia) and cylinder (amount of astigmatism at an angle (axis)). Spherical equivalent (SE) is defined as the sphere plus 1/2 the cylinder. A SE was calculated for each eye for each of the five trials of cycloplegic autorefraction, and the median for each eye was averaged to obtain the SE used for analysis.|3 years|The analysis followed the intent-to-treat principle.||participants|||Number
723016|NCT00320606|Secondary|Changes in Renal Function, Blood Pressure, Cholesterol Level, and Glucose Control||throughout trial||02/2018||||
723017|NCT00320606|Secondary|Incidence of Adverse Events||throughout trial||02/2018||||
723018|NCT00320606|Secondary|Distribution of Histologic Severity Among Rejection Episodes||Immunosuppression to rejection||02/2018||||
723019|NCT00320606|Secondary|Time From Start of Immunosuppression to the First Episode of Acute Rejection or to Diagnosis of Chronic Rejection||Immunosuppression to first acute rejection or diagnosis of chronic rejection||02/2018||||
723020|NCT00320606|Primary|Proportion of Patients Who Suffer Graft Loss or Die Following Initiation of Immunosuppression Withdrawal||1 year||02/2018||||
723021|NCT00320606|Primary|Proportion of Subjects Successfully Withdrawn From Immunosuppression|Subjects were considered successfully withdrawn from immunosuppression if they remained off immunosuppression for at least one year with normal allograft function|1 year after completion of immunosuppression withdrawal|Intent-to-Treat||Participants|||Number
723035|NCT00320788|Post-Hoc|Mean Change of CR/LT From Baseline at Week 16|CR/LT measured in micrometers (µm); lower individual values represent better outcomes|Baseline and at Week 16|FAS used for analysis, LOCF||µm||Standard Deviation|Mean
723038|NCT00320788|Secondary|Mean Percent Change of CR/LT From Baseline at Week 12|CR/LT measured in micrometers (µm); a more negative percentage represents a better outcome|Baseline and at Week 12|FAS used for analysis, LOCF||percent change||Standard Deviation|Mean
723022|NCT00320671|Primary|Percentage of Participants That Responded to Treatment|Brief Psychiatric Rating Scale-Anchored (BPRS-A) 4 items on this scale were examined to determine subjects responder status: Items 4. Conceptual Disorganization 8. Grandiosity 12. Hallucinations and 15. Unusual Thought Content. Scores range from-7 (not assessed) to 7 (very severe) Subjects with scores of 3 or less on all 4 items for 2 consecutive visits are deemed responders, subjects with 4 or greater and any of the aforementioned items for 2 consecutive study visits are non responders. Additionally, the subjects response on the Clinical Global Impressions Scale. A Clinical Global Improvement CGI) rating of much or very much improved on 2 consecutive ratings were deemed a responder. Percentages and confidence intervals were used to report response outcome. Response status was assessed throughout the duration of the study; a participant can be deemed a responder any time between weeks 1-week 12. The possible range for this outcome is a score of 4 to 28|this outcome was assessed throughout the study.|BPRS-A and CGI scores for each group were analysed to determine the percentage of participants that responded to apriprazole and risperidone. The threshold for significance was p=.05||percentage of response||95% Confidence Interval|Number
723023|NCT00320710|Secondary|Skeletal Morbidity Rate|An SMR for a patient was defined as the “number of occurrences” of any (or a particular) SRE allowing for only 1 event in any 3-week interval, divided by the “time at risk” in years. The “number of occurrences” and the “time at risk” were counts of SRE and the time from the randomization date. Counting began from randomization in the way that every counted event was followed by a 20-day period during which no SRE was counted, nor was the time counted as “at risk”. For example, if a patient had 1 SRE during the study, the “time at risk” was calculated as the total number of days in the study minus the 20-day follow-up period for that SRE. If a patient had no SRE events, the entire study period was counted as “time at risk”. This SMR calculation method had the advantage of avoiding multiple counts of possibly interdependent SREs (e.g. having 1 fracture increases the probability of having a subsequent SRE).|52 weeks|This population included all participants who were in the zoledronic acid q 4 weeks and zoledronic acid q 12 weeks treatment groups.||Number of events per year||Standard Deviation|Mean
723024|NCT00320710|Secondary|Change From Baseline in Serum Bone Specific Alkaline Phosphatase|Serum samples were collected to obtain bone specific alkaline phosphatase values.|baseline, 48 weeks|The population included participants who were in the zoledronic acid q4 weeks and zoledronic acid q12 weeks treatment groups and had both baseline and week 48 values.||mcg/L||Standard Deviation|Mean
723025|NCT00320710|Secondary|Change From Baseline in Urinary N-telopeptide / Creatinine Ratio|Urine samples were collected to obtain n-telopeptide and creatinine values.|baseline, 48 weeks|The population included participants who were in the zoledronic acid q4 weeks and zoledronic acid q12 weeks treatment groups and had both baseline and week 48 values.||ratio||Standard Deviation|Mean
723026|NCT00320710|Secondary|Change From Baseline in Mean Analgesic Score|The analgesic score indicates the types of pain medication used. The scores range as follows: 0 = none medication; 1 = minor analgesics (aspirin, NSAID, acetaminophen, propoxyphene, etc.); 2 = Tranquilizers, antidepressants, muscle relaxants, and steroids; 3 = Mild narcotics (oxycodone, meperidine, codeine, etc.); and 4 = Strong narcotics (morphine, hydromorphone, etc.). A positive change from baseline indicates worsening.|baseline, 52 weeks|The population included participants who were in the zoledronic acid q4 weeks and zoledronic acid q12 weeks treatment groups and had both baseline and week 52 values.||score||Standard Deviation|Mean
723027|NCT00320710|Secondary|Change From Baseline in Mean Composite Brief Pain Inventory (BPI) Score|Participants completed a BPI short form which is a 9 item self-administered questionnaire used to evaluate the severity of a participant's pain and the impact of this pain on the participant's daily functioning. The participant rates his or her worst, least, average, and current pain intensity, lists current treatments and perceived effectiveness, and rates the degree that pain interferes with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life on a 10 point scale. The BPI composite score, which was calculated as the average of items 3, 4, 5 and 6 (worst pain, least pain, average pain and pain right now), ranged from 0 (best possible outcome, no pain) to 10 (worst possible outcome, pain as bad as you can imagine). A positive change from baseline indicates worsening.|baseline, 52 weeks|The population included participants who were in the zoledronic acid q4 weeks and zoledronic acid q12 weeks treatment groups and had both baseline and week 52 values.||scores on a scale||Standard Deviation|Mean
723028|NCT00320710|Secondary|Time to First Individual Type of SRE|Types of SREs analyzed were pathologic fractures (vertebral and non-vertebral), spinal cord compression, radiation to bone and surgery to bone. The time to first indvidual SRE was defined as the date of randomization to the date of the first occurrence of any individual SRE.|52 weeks|The population included participants who were in the zoledronic acid q4 weeks and zoledronic acid q12 weeks treatment groups.||Weeks||95% Confidence Interval|Median
723029|NCT00320710|Secondary|Time to First SRE|An SRE was defined as a pathologic bone fracture (vertebral and non-vertebral), spinal cord compression, radiation to bone, or surgery to bone. The time to first individual SRE was defined as the date of randomization to the date of first occurrence of any SRE.|52 weeks|The population included participants who were in the zoledronic acid q4 weeks and zoledronic acid q12 weeks treatment groups.||Days||95% Confidence Interval|Median
723030|NCT00320710|Primary|Proportion of Patients Who Experienced at Least One Skeletal Related Event (SRE)|An SRE was defined as a pathologic fracture (vertebral and non-vertebral), spinal cord compression, radiation to bone or surgery to bone.|52 weeks|The population included participants who were in the zoledronic acid q4 weeks and zoledronic acid q12 weeks treatment groups.||Percentage of participants|||Number
723031|NCT00320749|Secondary|Therapeutic Response|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|every 8 weeks, up to 24 weeks|3 patients were non-evaluable for response or progression free survival as they withdrew consent after cycle 1 of therapy.||percent of patients|||Number
723032|NCT00320749|Secondary|Common Toxicities|The NCI Common Terminology Criteria for Adverse Events version 3.0 was used for adverse event reporting and toxicity grading.|Weekly up to 24 weeks|grade 3 and grade 4 toxicities according to National Cancer Institute [NCI] Common Toxicity Criteria for Adverse Events [CTCAE], Version 3.0||percent of patients|||Number
723040|NCT00320801|Primary|The Number of Participants With Adverse Events (AEs) as a Measure of Safety.|Safety assessments included monitoring and recording of all adverse events and serious adverse events (SAEs).|Throughout BTDS exposure (Includes run-in period, double-blind phase and extension phase)|The safety population consists of all subjects who received at least 1 dose of study drug and had at least 1 safety assessment after the initial dose of BTDS in the study.||Participants|||Number
723041|NCT00321269|Secondary|Health-Related Quality of Life|Medical Outcomes Study SF-36 Physical Function Subscale- 10 Items Range 0 to 100, Higher Scores indicate higher functioning.|Measured at week 1, week 8|Older Veterans with Congestive Heart Failure||units on a scale||Standard Deviation|Mean
723042|NCT00321269|Primary|Beck Depression Inventory II|Depressive Symptoms measured on a Beck Depression Inventory Revised Possible Range 0 to 63. Higher scores indicate greater depression. Effectiveness of treatment indicated by a decline in the BDI-II score.|Depression and psychological health will be assessed at week 1, week 8|Older Veterans with Heart Failure||units on a scale||Standard Deviation|Mean
723043|NCT00321321|Primary|Insulin Secretion|area under the curve AUC and insulin secretion rate|0 - 90 minutes|||pmol/l * 90 minutes|||Number
723044|NCT00321373|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs).|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 30-day (Days 0-29) follow-up period after vaccination|The analysis was based on the Total Vaccinated Cohort which included all vaccinated subjects.||Subjects|||Number
723045|NCT00321373|Secondary|Number of Subjects With Any and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Any = occurrence of any SAE regardless of intensity grade or relation to vaccination. Related = SAE assessed by the investigator as related to the vaccination.|During the entire study period (Day 0 to Day 180)|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects.||Subjects|||Number
723046|NCT00321373|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.|Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as oral temperature equal to or above 37.5 degrees Celsius (°C)], headache, muscle aches, shivering. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day (Days 0-6) follow up period after vaccination|The analysis was based on the Total vaccinated Cohort which included all vaccinated subjects with the symptom sheet completed.||Subjects|||Number
723047|NCT00321373|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms.|Assessed solicited local symptoms were ecchymosis, pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 ecchymosis/redness/swelling = ecchymosis/redness/swelling spreading beyond 50 millimeters (mm) of injection site.|During the 7-day (Days 0-6) follow-up period after vaccination|The analysis was based on the Total Vaccinated Cohort that included all vaccinated subjects with the symptom sheet completed.||Subjects|||Number
723048|NCT00321373|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Virus|Titers are presented as geometric mean titers (GMTs). The 3 flu strains assessed were A/New Caledonia, A/New York and B/Malaysia. The reference seropositivity cut-off value was ≥ 1:10.|At Day 180 post-vaccination.|The analysis was based on the ATP cohort for immunogenicity at Day 180 including subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination at this time point.||titer||95% Confidence Interval|Geometric Mean
723049|NCT00321373|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Virus|Titers are presented as geometric mean titers (GMTs). The 3 flu strains assessed were A/New Caledonia, A/New York and B/Malaysia. The reference seropositivity cut-off value was ≥ 1:10.|At Days 0 and 21 post-vaccination|The analysis was based on the ATP cohort for immunogenicity at Day 21 including subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination at this time point.||titer||95% Confidence Interval|Geometric Mean
723050|NCT00321464|Secondary|Time to First and Subsequent On-Study Skeletal-Related Event|Time to first and subsequent on-study skeletal-related event (SRE) using a multiple event analysis. To be considered a subsequent SRE, the event must occur at least 21 days after the previous SRE. This outcome measure utilizes multiple event times, was analyzed based on a proportional mean model, and is therefore more appropriately summarized by the cumulative number of events.|Up to 34 months|Full Analysis Set, composed of all randomized participants||Events|||Number
723051|NCT00321464|Secondary|Time to First On-Study Skeletal-Related Event (Superiority)|Time to first on-study skeletal-related event (SRE) using a superiority analysis. The median time to first skeletal-related event could not be estimated in one treatment arm, so the subject incidence is presented.|Up to 34 months|Full Analysis Set, composed of all randomized participants.||Participants|||Number
723052|NCT00321464|Primary|Time to First On-Study Skeletal Related Event (SRE) (Non-inferiority)|Time to first on-study skeletal-related event (SRE) using a non-inferiority analysis. The median time to first skeletal-related event could not be estimated in one treatment arm, so the subject incidence is presented.|Up to 34 months|Full Analysis Set, composed of all randomized participants.||Participants|||Number
723053|NCT00321594|Primary|Tumor Response in Patients With Inoperable HCC Using Belinostat (Phase II)|Evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. The 95% confidence intervals should be provided.|Every 2 courses (approximately 6 weeks)|||Participants|||Count of Participants
723117|NCT00329238|Secondary|Number of Participants With Definite Acute Coronary Syndrome (ACS)|All suspected ACS occurring during the trial were to be recorded on the CRF and were to be centrally adjudicated by an independent ACS/AC in a treatment-blinded manner.|day of first study drug intake until last day of study drug intake; from the day after last intake of study drug until trial termination|FAS as treated||participants|||Number
723054|NCT00321594|Primary|Dose-limiting Toxicities (DLT) and Maximum Tolerated Dose (MTD) of Belinostat in Patients With Inoperable HCC (Phase I)|DLT is defined as any grade 4 hematological toxicity and any grade 3 or 4 non hematological toxicity during cycle 1, excluding alopecia. Specifically, grade 3 nausea, vomiting, or diarrhea that does not respond to therapy is considered dose-limiting. Also, delays in treatment greater than 2 weeks are also dose-limiting. MTD is defined as the dose below which >= 2 of 3 or >= 2 of 6 patients experience DLT. Graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|Course 1|||Participants|||Count of Participants
723055|NCT00321620|Secondary|Time to the First-And-Subsequent On-Study SRE|"Time to the first-and-subsequent on-study skeletal-related event (SRE), analyzed for superiority of denosumab using multiple event analysis, the event must occur at least 21 days after the previous SRE.
This outcome measure utilizes multiple event times, was analyzed based on a proportional mean model, and is therefore more appropriately summarized by the cumulative mean number of events."|Up to 40.5 months|Full Analysis Set, composed of all randomized participants||Events|||Number
723056|NCT00321620|Secondary|Time to the First On-Study SRE (Superiority)|Time to the first on-study skeletal-related event (SRE), analyzed for superiority of denosumab. Kaplan-Meier estimates of the median and its dispersion are reported.|Up to 40.5 months|Full Analysis Set, composed of all randomized participants||Days||95% Confidence Interval|Median
723057|NCT00321620|Primary|Time to the First On-Study SRE (Non-inferiority)|Time to the first on-study skeletal-related event (SRE) analyzed for non-inferiority. Kaplan-Meier estimates of the median and its dispersion are reported.|Up to 40.5 months|Full Analysis Set, composed of all randomized participants||Days||95% Confidence Interval|Median
723058|NCT00321646|Secondary|PSA Response After Completing 6 Cycles of Neoadjuvant Chemotherapy.|The rate of PSA decline by 50% compared to baseline PSA.|after 6 months of ajuvant chemotherapy.|||proportion of participants||95% Confidence Interval|Number
723059|NCT00321646|Primary|Endorectal MRI Response After Completion of 6 Cycles of Neoadjuvant Therapy|A response was defined as a decrease in tumor size of >50% for the largest lesion in the prostate by endorectal MRI.|after 6 months of neoadjuvant chemotherapy.|||proportion of participants||95% Confidence Interval|Number
723060|NCT00328016|Secondary|End Tidal CO2 (PetCO2)|End tidal CO2 was monitored continuously using a respiratory gas monitor|After 15 minutes of guided breathing or control task|||mmHg||Standard Error|Mean
723061|NCT00328016|Secondary|Minute Ventilation|Minute Ventilation was continuously monitored via inductive plethysmography|After 15 minutes of guided breathing or control task|||L/min||Standard Error|Mean
723062|NCT00328016|Primary|Breathing Rate|Breathing rate was monitored continuously via inductive plethysmography.|After 15 minutes of guided breathing or control task|||Breaths/minute||Standard Error|Mean
723063|NCT00328042|Secondary|Hepatitis C Knowledge Questionnaire|The measure consists of 15 questions covering Hepatitis C-specific information related to disease self-management. Each correct response is scored as one point, with total scores range from 0 to 15. Higher scores indicate higher levels of Hepatitis C-specific knowledge. There are no subscales.|Base Line, 6 weeks|||units on a scale||Standard Deviation|Mean
723064|NCT00328042|Primary|Quality of Well-being Scale - Self-Administered (QWB-SA)|The QWB-SA is a preference-based measure of health-related quality of life. Scores range from 0 to 1.0, with 0 representing death, and 1.0 representing asymptomatic, optimal functioning. Thus, higher scores indicate higher quality of life.|Base Line, 12 months|||units on a scale||Standard Deviation|Mean
723065|NCT00328094|Primary|Composite (Myocardial Infarction and CHF)||hospital length of stay|||Number of patients|||Number
723066|NCT00328094|Secondary|Incidence of Wound Infections||postoperative|||participants|||Number
723067|NCT00328172|Secondary|Percentage of Patients With Absolute Efficacy Response (HbA1c <= 7.0%) at 12 Weeks|An absolute efficacy response is defined as HbA1c <= 7.0% at 12 weeks. A non-response is defined as HbA1c > 7.0% at 12 weeks.|Baseline, week 12|FAS patients with baseline HbA1c > 7.0%. Non-completers were considered as failure imputation (NCF).||participants|||Number
723068|NCT00328172|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12|Change from baseline reflects the Week 12 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG.|Baseline, week 12|Full Analysis Set includes all randomized patients with baseline and on-treatment value of HbA1c. Last observation carried forward (LOCF) was used as the imputation rule.||mg/dL||Standard Error|Least Squares Mean
723069|NCT00328172|Primary|Change From Baseline in HbA1c (Glycosylated Haemoglobin) at Week 12|The change from baseline reflects the Week 12 HbA1c minus the Week 0 HbA1c. Means are adjusted for baseline HbA1c.|Baseline, week 12|Full Analysis Set includes all randomized patients with baseline and on-treatment value of HbA1c. Last observation carried forward (LOCF) was used as the imputation rule.||percent||Standard Error|Least Squares Mean
723070|NCT00328198|Primary|Percentage of Participants Who Had an Overall Response (OR) as Determined by the Independent Response Review Panel (IRRP)|Participants were evaluated by the IRRP according to National Cancer Institute (NCI) 1996 response criteria. The percentage of participants whose best response observed during the study was either a Complete Response (CR) or a Partial Response (PR). Overall Response (OR) = CR + PR. A Complete Response (CR) exhibits a normal physical exam, marrow cells and blood values. A Partial Response (PR) has a >= 50% decrease from baseline in lymphocytes, lymphadenopathy and liver or spleen exam.|up to 44 weeks|Full analysis set. 95% confidence interval calculated using exact binomial method.||percentage of participants||95% Confidence Interval|Number
723071|NCT00328198|Secondary|Participants With Treatment-Emergent Adverse Events (TEAE)|Number of participants with treatment-emergent adverse events (TEAEs). AEs were graded by the investigator using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and were assessed for relatedness to study treatment (5 point scale from 'not related' to 'definitely related') and severity (5 point scale with grade 5 being most severe). Categories reported include participant counts for treatment-emergent AEs, injection site reactions, AEs for infections, serious AEs, AEs causing discontinuation of study drug(s), deaths and severity.|up to 18 weeks of treatment plus 45 days|Full analysis set||participants|||Number
723091|NCT00328926|Secondary|Percentage of Participants With Cumulative Ovulation|Ovulation was defined as a mid-luteal phase progesterone (P4) level greater than or equal to (>=) 10 nanogram per milliliter (ng/mL). Cumulative ovulation referred to all ovulations that occurred during all the 3 treatment cycles.|Recombinant human chorionic gonadotropin (r-hCG) administration day (end of stimulation cycle [approximately 21 days])|ITT population included all participants who were treated to trial treatment.||Percentage of participants|||Number
723072|NCT00328198|Secondary|Participants With a Minimal Residual Disease (MRD) Status of Negative|MRD negativity represents a very positive response outcome. MRD negativity in this report was defined by the absence of tumor cells in bone marrow, using 4-color flow cytometry. All patients are evaluated for treatment response based on National Cancer Institute Working Group (NCIWG) criteria. Of patients who have achieved a clinical complete response (CR) or partial response (PR) that met National Cancer Institute Working Group (NCIWG) criteria of CR except blood recovery, a bone marrow sample was taken for flow cytometry measure of MRD negativity.|44 weeks|Full analysis set||participants|||Number
723073|NCT00328198|Secondary|Kaplan-Meier Estimates of Overall Survival|Overall survival was defined as the time in days from the date of first treatment to the date of death due to any cause for all participants. Results are stated in months.|up to 5 years|Full analysis set||months||95% Confidence Interval|Median
723074|NCT00328198|Secondary|Kaplan-Meier Estimates of Duration of Response as Determined by the Independent Response Review Panel (IRRP)|"Duration of response was analyzed for participants who achieved a complete response (CR) or partial response (PR) and was defined as the number of days from the first date of documented response to the date of progressive disease (PD) as determined by IRRP or death due to any cause. Results are stated in months.
Progressive Disease (PD) was defined as an increase in size/number of nodes, size of liver or spleen, increase in lymphocytes, or aggressive histology."|up to 5 years|Participants who had a complete response or a partial response||months||95% Confidence Interval|Median
723075|NCT00328198|Secondary|Kaplan-Meier Estimates of Progression Free Survival as Determined by the Independent Response Review Panel (IRRP)|"Progression-free survival was defined as the number of days from the date of first treatment to the date of first objective documentation of progressive disease (PD) as determined by the IRRP, or death due to any cause. Results are expressed in months.
Progressive Disease (PD) was defined as an increase in size/number of nodes, size of liver or spleen, increase in lymphocytes, or aggressive histology."|up to 5 years|Full analysis set||months||95% Confidence Interval|Median
723076|NCT00328198|Primary|Number of Participants With Best Disease Response as Determined by the Independent Response Review Panel (IRRP)|Participants were evaluated by the IRRP according to National Cancer Institute (NCI) 1996 response criteria. The best response observed during the study is summarized. Response categories include Complete Response (CR) with normal physical exam, marrow cells and blood values, Partial Response (PR) with a >= 50% decrease from baseline in lymphocytes, lymphadenopathy and liver or spleen exam, Stable Disease (SD) without significant progression from baseline, or Progressive Disease (PD) with increased size/number of nodes, size of liver or spleen, increase in lymphocytes, aggressive histology.|up to 44 weeks|Full analysis set||participants|||Number
723077|NCT00328263|Secondary|Safety Profile of BIO-K+CL1285® Versus Placebo in Patients on Antibiotics|Safety was assessed by the incidence of treatment-emerged adverse events, which were reported according to MedDRA 10.1|Up to 40 days||||||
723078|NCT00328263|Secondary|Health Outcome Evaluation Will Look at the Direct Medical Costs and Clinical Outcomes of Alternative Strategies in the Prevention of Antibiotic-associated Diarrhea in Hospitalized Adult Patients||Up to 40 days||||||
723079|NCT00328263|Secondary|Positive Results for Clostridium Difficile (C. Difficile) Toxin A or B in Antibiotic Associated Diarrhea Patients.|Testing for CDAD was performed at the discretion of the treating physician and according to the protocol in place at the study centers. CDAD was defined as an episode of diarrhea and positive results for C. difficile Toxin A or B.|Up to 40 days||||||
723080|NCT00328263|Primary|The Incidence of Antibiotic-associated Diarrhea.|Presence of at least one diarrhea episode within 24 hours.|Up to 40 days|||participants|||Number
723081|NCT00328770|Secondary|Sirolimus Toxicity/Intolerance|Sirolimus toxicity/intolerance requiring discontinuation of sirolimus|1 year|||participants|||Number
723082|NCT00328770|Primary|Percentage of Participants Surviving With no Evidence of Recurrent Tumor at One and Four Years After Liver Transplant|Percentage of Participants Surviving with no Evidence of Recurrent Hepatocellular Carcinoma at One and Four Years After Liver Transplant|1 and 4 years|||percentage of participants|||Number
723083|NCT00328770|Primary|Percentage of Participants Surviving at One and Four Years After Liver Transplant|Percent of Patients Surviving at One & Four years after Liver Transplant was calculated|1 & 4 years|Percentage of patients surviving to 1 and 4 years after liver transplant was calculated for all patients||percentage of participants|||Number
723084|NCT00328783|Primary|Proportion of Patients With Reduction in Radiation||30 days|||proportion of patients||95% Confidence Interval|Number
723085|NCT00328783|Secondary|Toxicity Monitoring|To monitor the toxicity of treatment of adjuvant radiotherapy for breast cancer with the ABC device.|30 days post-treatment||||||
723086|NCT00328783|Secondary|Improvement in Normal Tissue Irradiation|To evaluate whether potential improvement in normal tissue irradiation can be predicted from standard simulation films, without subjecting patients to free-breathing plus controlled breathingCT scans|30 days post-treatment||||||
723087|NCT00328783|Secondary|Toxicity Evaluation|To evaluate toxicity of ABC in breast cancer patients receiving adjuvant breast radiotherapy|30 days post-treatment||||||
723088|NCT00328783|Primary|Dosimetric Evaluation Magnitude of Reduction in Irradiated Normal Tissues|"To evaluate the magnitude of reduction in irradiated normal tissues (heart and lung) when using the Active Breathing Coordinator (ABC) in breast patients, as compared to standard, free-breathing.
The generated dose distributions from the free-breathing vs. ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms. Specifically, for the heart, the volume receiving 55 and 40 Gy will be evaluated; for the liver the volume receiving 50 and 36 Gy, and for the lung, the volume receiving 20 Gy. For the contralateral breast the volume receiving 20 Gy, 30 Gy and 50 Gy will be evaluated. Patients will be treated with the ABC device if there is at least 5 % relative reduction in the volume of a normal tissue irradiated to prescription dose."|At time of radiation|||Gy||95% Confidence Interval|Mean
723089|NCT00328861|Secondary|Safety|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|11/30/2006 - 7/31/2007|||Participants|||Number
723090|NCT00328861|Primary|Objective Response|Objective response (complete response (CR) or partial response (PR)) is measured by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete response (CR) is the disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.|very 4-6 weeks for up to 1 year, and then every 6 months for up to 5 years.|||Participants|||Number
723092|NCT00328926|Secondary|Percentage of Participants With Cumulative Clinical Pregnancy|Clinical pregnancy was defined as the presence of one or more fetal sac with fetal heart activity on the Day 35-42 post r-hCG ultrasound examination. Cumulative clinical pregnancy referred to all clinical pregnancy that occurred during all the 3 treatment cycles.|Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 21 days])|ITT population included all the participants who received study treatment.||Percentage of participants|||Number
723093|NCT00328926|Primary|Time to Clinical Pregnancy|Clinical pregnancy was defined as the presence of one or more fetal sac with fetal heart activity on the Day 35-42 post r-hCG ultrasound examination.|Stimulation Day 1 up to clinical pregnancy (Day 35-42 post r-hCG administration day [end of stimulation cycle {approximately 21 days}])|Intention-to-treat (ITT) population included all the participants who received study treatment. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.||Days||Full Range|Median
723094|NCT00329030|Secondary|Neutrophil Recovery|Time to neutrophil recovery will be the first of two consecutive days of > 500 neutrophils/μL following the expected nadir.|Day 28 and Day 60|||percentage of participants||95% Confidence Interval|Number
723095|NCT00329030|Secondary|Treatment-related Mortality (TRM)|TRM is defined as death occurring in a patient from causes other than relapse or progression|1 and 2 years|||percentage of participants||95% Confidence Interval|Number
723096|NCT00329030|Secondary|Immune Reconstitution of Quantitative Immunoglobulins|Tests to be performed on peripheral blood for quantitative immunoglobulins include IgM, IgG and IgA.|1 year|||mg/dL||Standard Deviation|Mean
723097|NCT00329030|Secondary|Immune Reconstitution|Tests to be performed on peripheral blood include CD2, CD3, CD4, CD8, CD19, CD3+/CD25+, CD45 RA/RO, CD56+/CD3-.|1 year|||cells/uL||Standard Deviation|Mean
723098|NCT00329030|Secondary|Mucositis Severity|Mucositis severity will be scored per the modified Oral Mucositis Assessment Scale (OMAS) scoring system on a scale of 0 - 4, where 0 equals normal mucosa and 4 equals severe mucosa.|Day 21|||scores on a scale||Full Range|Median
723099|NCT00329030|Secondary|Incidence of Infection||1 year|67 patients treated with B-BEAM incurred a total of 139 infections. 60 patients treated with R-BEAM incurred a total of 121 infections.||participants|||Number
723100|NCT00329030|Secondary|Hematologic Function|Hematologic function will be defined as ANC > 1,500 neutrophils/μL, hemoglobin > 10 g/dL without transfusion support, and platelet count > 100,000/μL without transfusion support.|100 days, 1 year|||percentage of participants||95% Confidence Interval|Number
723101|NCT00329030|Secondary|Platelet Recovery to 20,000 Cells/μL||100 and 180 days|||percentage of participants||95% Confidence Interval|Number
723102|NCT00329030|Secondary|Complete Response (CR) and Partial Response (PR) Proportion||Day 100 and 2 years|||percentage of participants||95% Confidence Interval|Number
723103|NCT00329030|Secondary|Incidence of Relapse/Progression|The time to this event is measured from randomization. Deaths without relapse/progression are considered as a competing risk. Surviving patients with no history of relapse/progression are censored at time of last follow-up.|1 and 2 years|||percentage of participants||95% Confidence Interval|Number
723104|NCT00329030|Secondary|Overall Survival|The event is death from any cause. The time to this event is the time from randomization to death or last follow-up. Surviving patients are censored at the time of last observation|1 and 2 years|||percentage of participants||95% Confidence Interval|Number
723105|NCT00329030|Primary|Progression-free Survival (PFS)|Patients are considered a failure for this endpoint if they die, relapse/progress, or receive anti-lymphoma therapy, other than post-transplant consolidative localized radiation (maximum 3 sites) to sites of prior bulk disease pre-transplant (> 3cm). The time to this event is the time from randomization until death, relapse/progression, receipt of anti-lymphoma therapy, or last follow up, whichever comes first.|1 and 2 years|||percentage of participants||95% Confidence Interval|Number
723106|NCT00329108|Secondary|Percentage of Patients With Symptomatic Relapse of Mania and/or Symptomatic Relapse of Depression During the Open Label Phase.||6 months||||||
723107|NCT00329108|Secondary|Percentage of Patients With Clinical Response After 6 Weeks of Double-blind Treatment.||6 weeks||||||
723108|NCT00329108|Secondary|Time to Symptomatic Remission in the Double Blind Phase.||up to 10 weeks||||||
723109|NCT00329108|Secondary|Percentage of Patients With Symptomatic Remission After 4, 6 and 10 Weeks of Treatment and at the End of the Double-blind Phase.||4, 6 and 10 weeks||||||
723110|NCT00329108|Secondary|Change From Baseline in Global Assessment of Functioning Scale Scores, Treatment Satisfaction Questionnaire for Medication, Quality of Life Enjoyment and Satisfaction Questionnaire in the Double Blind Phase.||6 months||||||
723111|NCT00329108|Secondary|Change From Baseline in Clinical Global Impressions Scale for Use in Bipolar Illness Scores; Montgomery Asberg Depression Scale Scores in the Double Blind Phase.||up to 10 weeks||||||
723112|NCT00329108|Primary|Mean Reduction in Young Mania Rating Scale (YMRS) Score During the Double Blind Phase.|YMRS is 11-item instrument with scales between 0 to 4 for 7 items and scales between 0 and 8 for 4 items. 0 is normal and either 4 or 8 is the highest level of abnormal, depending on the item.|4 weeks|Study was terminated due to poor recruitment and no efficacy data were summarized due to very low sample size. Only safety data were summarized.||score on scale|||Number
723113|NCT00329160|Secondary|Percent Change in High-sensitivity C-reactive Protein (HS-CRP) From Baseline to Specified Measurement Time Points||Baseline - 76Weeks|||Percent change||Standard Deviation|Mean
723114|NCT00329160|Secondary|Percent Change From Baseline to Specified Measurement Time Points in Low-density Lipoprotein （LDL-C）||Baseline - 76Weeks|||Percent change||Standard Deviation|Mean
723115|NCT00329160|Secondary|Change From Baseline to Week 76 in Plaque Volume (PV) in the Target Lesion|Target Lesion indicates Coronary plaque composition of culprit lesions.|Baseline - 76Weeks|||mg/dL||Standard Deviation|Mean
723116|NCT00329160|Primary|Percent Change From Baseline (Before the Start of Rosuvastatin Treatment) to Week 76 in the Plaque Volume (PV)|Plaque volume will be assessed by volumetric analysis with the echoPlaque2 system (Indec Systems Inc). Baseline and follow-up IVUS images will be reviewed side-by-side on a display, and the target segment selected. The target segment to be monitored will be determined in a non-PCI site (>5 mm proximal or distal to the PCI site) with a reproducible index such as side branches, calcifications, or stent edges.|Baseline and 76 weeks|||Percent Change||Standard Deviation|Mean
723118|NCT00329238|Secondary|Laboratory Analysis|Patients with LFT (liver function tests) increases of possible clinical significance during treatment. Increases of possible clinical significance were defined as: ≥3 x ULN (AST, ALT), ≥2 x ULN (AP), and ≥2 mg/dL (total bilirubin). Only patients with a baseline value which was not of possible clinical significance (or without any baseline value) could have a PCSA (Possible clinically significant abnormality).|18 months + 30 days follow up|FAS as treated||participants|||Number
723119|NCT00329238|Secondary|Number of Participants With Bleeding Events|"MBE (major bleeding event) if it fulfilled at least one of the following criteria
Fatal bleeding
Symptomatic bleeding in a critical area or organ.
Bleeding causing a fall in haemoglobin level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of 2 or more units of whole blood or red cells.
Minor bleeding event was any bleeding that did not fulfil any of the criteria for MBEs
CRBE (clinically relevant bleeding event) if it is a minor bleeding events which fulfilled at least one of the following criteria
Spontaneous skin haematoma ≥25 cm2
Spontaneous nose bleed >5 min duration
Macroscopic haematuria, either spontaneous or, if associated with an intervention, lasting >24 h
Spontaneous rectal bleeding
Gingival bleeding >5 min
Bleeding leading to hospitalisation or requiring surgical treatment
Bleeding leading to a transfusion of <2 units of whole blood or red cells
Any other bleeding event considered clinically relevant by the investigator"|first intake of study drug until 6 days following last intake of study drug|FAS as treated||participants|||Number
723120|NCT00329238|Secondary|Deaths of All Causes at 18 Months|Deaths of all causes at 18 Months. All components of the primary efficacy endpoint and all deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death without knowledge of any individual treatment assignments.|18 months|FAS||Participants|||Number
723121|NCT00329238|Secondary|Deaths of All Causes at 36 Months|Deaths of all causes at 36 Months. All components of the primary efficacy endpoint and all deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death without knowledge of any individual treatment assignments.|36 months|FAS||Participants|||Number
723122|NCT00329238|Secondary|Deaths Related to VTE at 18 Months|Deaths related to VTE (i.e. fatal PE) at 18 Months. All deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death in a treatment-blinded way.|18 months|FAS||Participants|||Number
723123|NCT00329238|Secondary|Deaths Related to VTE at 36 Months|Deaths related to VTE (i.e. fatal PE) at 36 Months. Deaths related to VTE (i.e. fatal PE) at 18 Months. All deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death in a treatment-blinded way.|36 months|FAS||Participants|||Number
723124|NCT00329238|Secondary|Symptomatic Pulmonary Embolism (PE) at 18 Months|Symptomatic pulmonary embolism (PE) at 18 Months (fatal or non-fatal). All suspected PEs required confirmation by one of the following: ventilation-perfusion (V-Q) lung scan, pulmonary angiography, or spiral (helical) Computed tomography.|18 months|FAS||Participants|||Number
723125|NCT00329238|Secondary|Symptomatic Pulmonary Embolism (PE) at 36 Months|Symptomatic pulmonary embolism (PE) at 36 Months (fatal or non-fatal). All suspected PEs required confirmation by one of the following: ventilation-perfusion (V-Q) lung scan, pulmonary angiography, or spiral (helical) Computed tomography.|36 months|FAS||Participants|||Number
723126|NCT00329238|Secondary|DVT at 18 Months|Symptomatic Deep vein thrombosis (DVT). All DVT events required objective verification through definitive diagnostic evaluation.|18 months|FAS||Participants|||Number
723127|NCT00329238|Secondary|Deep Vein Thrombosis (DVT) at 36 Months|Symptomatic Deep vein thrombosis (DVT). All DVT events required objective verification through definitive diagnostic evaluation.|36 months|FAS||Participants|||Number
723128|NCT00329238|Secondary|Composite of Recurrent VTE or All Cause Death at 18 Months|Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and all cause death. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation.|18 months|FAS||Participants|||Number
723129|NCT00329238|Secondary|Composite of Recurrent VTE or All Cause Death at 36 Months|Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and all cause death. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation.|36 months|FAS||Participants|||Number
723130|NCT00329238|Primary|Composite of Recurrent VTE or VTE Death at 18 Months|Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and death related to VTE. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation. In case of death, autopsy was an additional way to confirm VTE.|18 months|FAS||Participants|||Number
723131|NCT00329238|Primary|Composite of Recurrent VTE or VTE Death at 36 Months|Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and death related to VTE. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation. In case of death, autopsy was an additional way to confirm VTE.|36 months|FAS||Participants|||Number
723132|NCT00329407|Secondary|Phonetic Portion of the Controlled Word Association Test (COWAT)|Phonetic COWAT is a measure of verbal fluency. Results are in terms of number of words produced starting with a set of particular letters.This involves a comparison of baseline and Week 10 COWAT scores|Baseline compared to Week 10|||Number of words||Standard Error|Mean
723133|NCT00329407|Primary|The Primary Outcome Measure Will be Subjects Ethanol Consumption Over the Course of the Drug Treatment Period as Assessed by the Timeline Followback Method|The primary outcome was the mean daily consumption of standard alcoholic drinks (14 g per ethanol) during the baseline week compared to week 10, the final week subjects were one maintenance dose of topirmate.|70 days|An ITT approach was used in the analysis. Least squares value for the baseline and 10 week of treatment were compared using a t test with Dunnett-Hsu adjustment. Differences between these means are presented as the result.||Standard Drink (14 g alcohol)||Standard Error|Mean
723160|NCT00329420|Secondary|C-Reactive Protein (CRP) Level at Week 28||Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||mg/L||Full Range|Geometric Mean
723134|NCT00329420|Post-Hoc|Number of Subjects With Disease Progression|"Disease progression is defined as:
an increase from Week 14 of ≥100 points in Crohn’s Disease Activity Index (CDAI) score and CDAI>175 points for at least 2 consecutive visits,
use of rescue therapy, or,
subject withdrawal from the study."|Week 14 to Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is the visit at which response to re-induction is assessed and 'Week 34' is 26 weeks after the first visit in this extension study.|Non-responders at Week 6 of Study C87037 (NCT00291668) could enter this extension study C87048 (NCT00329420). As it was not possible to calculate the time to disease progression (outcome measure 34) due to the very small number of subjects meeting this definition, the post-hoc outcome of number of subjects with disease progression is presented here||subjects|||Number
723135|NCT00329420|Secondary|Percentage of Subjects Achieving a Reduction in Crohn’s Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)|70-point responders are subjects achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.|"Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study."||percentage of subjects|||Number
723136|NCT00329420|Secondary|Percentage of Subjects Achieving a Reduction in Crohn’s Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 34|70-point responders are subjects achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.|"Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study."||percentage of subjects|||Number
723137|NCT00329420|Secondary|Percentage of Subjects Achieving a Reduction in Crohn’s Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 32|70-point responders are subjects achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.|"Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study."||percentage of subjects|||Number
723138|NCT00329420|Secondary|Percentage of Subjects Achieving a Reduction in Crohn’s Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 28|70-point responders are subjects achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.|"Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study."||percentage of subjects|||Number
723139|NCT00329420|Secondary|Percentage of Subjects Achieving a Reduction in Crohn’s Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 24|70-point responders are subjects achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|"Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study."||percentage of subjects|||Number
723140|NCT00329420|Secondary|Percentage of Subjects Achieving a Reduction in Crohn’s Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 20|70-point responders are subjects achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|"Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study."||percentage of subjects|||Number
723161|NCT00329420|Secondary|C-Reactive Protein (CRP) Level at Week 24||Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||mg/L||Full Range|Geometric Mean
723141|NCT00329420|Secondary|Percentage of Subjects Achieving a Reduction in Crohn’s Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 16|70-point responders are subjects achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|"Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study."||percentage of subjects|||Number
723142|NCT00329420|Secondary|Percentage of Subjects Achieving a Reduction in Crohn’s Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 14|70-point responders are subjects achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.|"Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study."||percentage of subjects|||Number
723143|NCT00329420|Secondary|Percentage of Subjects Achieving a Reduction in Crohn’s Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 12|70-point responders are subjects achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|"Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study."||percentage of subjects|||Number
723144|NCT00329420|Secondary|Percentage of Subjects Achieving a Reduction in Crohn’s Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 10|70-point responders are subjects achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.|"Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study."||percentage of subjects|||Number
723145|NCT00329420|Secondary|Percentage of Subjects Achieving a Reduction in Crohn’s Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 8|70-point responders are subjects achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|"Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study."||percentage of subjects|||Number
723146|NCT00329420|Secondary|Ratio of C-Reactive Protein (CRP) Level at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals) to CRP Level at Week 0|The ratio is calculated as the C-Reactive Protein (CRP) Level at Last Visit (Week 34 for completers or the Withdrawal Visit for premature withdrawals)divided by the CRP Level at Week 0|Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||ratio||Full Range|Geometric Mean
723147|NCT00329420|Secondary|Ratio of C-Reactive Protein (CRP) Level at Week 34 to CRP Level at Week 0|The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 34 divided by the CRP Level at Week 0|Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||ratio||Full Range|Geometric Mean
723148|NCT00329420|Secondary|Ratio of C-Reactive Protein (CRP) Level at Week 32 to CRP Level at Week 0|The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 32 divided by the CRP Level at Week 0|Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||ratio||Full Range|Geometric Mean
723263|NCT00329524|Primary|Change in PET Asymmetry Index|Change in calculated PET asymmetry index between left and right temporal lobe from baseline following active Tx|After active treatment week|||ratio||Standard Deviation|Mean
723149|NCT00329420|Secondary|Ratio of C-Reactive Protein (CRP) Level at Week 28 to CRP Level at Week 0|The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 28 divided by the CRP Level at Week 0|Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||ratio||Full Range|Geometric Mean
723150|NCT00329420|Secondary|Ratio of C-Reactive Protein (CRP) Level at Week 24 to CRP Level at Week 0|The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 24 divided by the CRP Level at Week 0|Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||ratio||Full Range|Geometric Mean
723151|NCT00329420|Secondary|Ratio of C-Reactive Protein (CRP) Level at Week 20 to CRP Level at Week 0|The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 20 divided by the CRP Level at Week 0|Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||ratio||Full Range|Geometric Mean
723152|NCT00329420|Secondary|Ratio of C-Reactive Protein (CRP) Level at Week 16 to CRP Level at Week 0|The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 16 divided by the CRP Level at Week 0|Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||ratio||Full Range|Geometric Mean
723153|NCT00329420|Secondary|Ratio of C-Reactive Protein (CRP) Level at Week 14 to CRP Level at Week 0|The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 14 divided by the CRP Level at Week 0|Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||ratio||Full Range|Geometric Mean
723154|NCT00329420|Secondary|Ratio of C-Reactive Protein (CRP) Level at Week 12 to CRP Level at Week 0|The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 12 divided by the CRP Level at Week 0|Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||ratio||Full Range|Geometric Mean
723155|NCT00329420|Secondary|Ratio of C-Reactive Protein (CRP) Level at Week 10 to CRP Level at Week 0|The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 10 divided by the CRP Level at Week 0|Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||ratio||Full Range|Geometric Mean
723156|NCT00329420|Secondary|Ratio of C-Reactive Protein (CRP) Level at Week 8 to CRP Level at Week 0|The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 8 divided by the CRP Level at Week 0|Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||ratio||Full Range|Geometric Mean
723157|NCT00329420|Secondary|C-Reactive Protein (CRP) Level at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)||Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||mg/L||Full Range|Geometric Mean
723158|NCT00329420|Secondary|C-Reactive Protein (CRP) Level at Week 34||Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||mg/L||Full Range|Geometric Mean
723159|NCT00329420|Secondary|C-Reactive Protein (CRP) Level at Week 32||Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||mg/L||Full Range|Geometric Mean
723162|NCT00329420|Secondary|C-Reactive Protein (CRP) Level at Week 20||Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||mg/L||Full Range|Geometric Mean
723163|NCT00329420|Secondary|C-Reactive Protein (CRP) Level at Week 16||Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||mg/L||Full Range|Geometric Mean
723164|NCT00329420|Secondary|C-Reactive Protein (CRP) Level at Week 14||Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||mg/L||Full Range|Geometric Mean
723165|NCT00329420|Secondary|C-Reactive Protein (CRP) Level at Week 12||Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||mg/L||Full Range|Geometric Mean
723166|NCT00329420|Secondary|C-Reactive Protein (CRP) Level at Week 10||Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||mg/L||Full Range|Geometric Mean
723167|NCT00329420|Secondary|C-Reactive Protein (CRP) Level at Week 8||Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||mg/L||Full Range|Geometric Mean
723168|NCT00329420|Secondary|C-Reactive Protein (CRP) Level at Week 0||Week 0 (relative to the start of the 6-week double-blind main study (N00291668)). 'Week 0' is the Baseline visit in the double-blind main study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||mg/L||Full Range|Geometric Mean
723169|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)|The Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723170|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 34|The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723171|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 32|The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723172|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 28|The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723173|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 24|The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723174|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 20|The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723175|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 16|The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723176|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 14|The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723177|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 12|The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723178|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 10|The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723179|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 8|The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723180|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)|The Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723181|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 34|The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723182|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 32|The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723183|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 28|The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723184|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 24|The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723185|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 20|The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723186|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 16|The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723187|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 14|The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723188|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 12|The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723189|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 10|The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723190|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 8|The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723191|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)|The Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723192|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 34|The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723193|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 32|The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723194|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 28|The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723195|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 24|The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723196|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 20|The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723197|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 16|The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723198|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 14|The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723199|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 12|The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723200|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 10|The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723201|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 8|The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723202|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)|The Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723203|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 34|The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723204|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 32|The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723205|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 28|The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723206|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 24|The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723207|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 20|The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723208|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 16|The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723209|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 14|The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723210|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 12|The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723211|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 10|The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723212|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 8|The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723213|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)|The Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723214|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 34|The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723215|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 32|The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723216|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 28|The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723217|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 24|The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723218|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 20|The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723219|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 16|The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723220|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 14|The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723221|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 12|The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723222|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 10|The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723223|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 8|The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723224|NCT00329420|Secondary|Time to Disease Progression|"Time to disease progression is defined as the earliest of:
time to an increase from Week 14 of ≥100 points in Crohn’s Disease Activity Index (CDAI) score and CDAI>175 points for at least 2 consecutive visits,
time to use of rescue therapy, or,
time to subject withdrawal from the study."|Week 14 to Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is the visit at which response to re-induction is assessed and 'Week 34' is 26 weeks after the first visit in this extension study.|Non-responders at Week 6 of Study C87037 (NCT00291668) could enter this extension study, C87048 (NCT00329420). As so few subjects experienced disease progression in this study it was not possible to calculate the median time to disease progression. Please see outcome measure 124 where the number of subjects with disease progression is presented.|||||
723225|NCT00329420|Secondary|Percentage of Subjects Achieving Remission at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.||Percentage of subjects|||Number
723226|NCT00329420|Secondary|Percentage of Subjects Achieving Remission at Week 34|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.||Percentage of subjects|||Number
723227|NCT00329420|Secondary|Percentage of Subjects Achieving Remission at Week 32|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.||Percentage of subjects|||Number
723228|NCT00329420|Secondary|Percentage of Subjects Achieving Remission at Week 28|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.||Percentage of subjects|||Number
723229|NCT00329420|Secondary|Percentage of Subjects Achieving Remission at Week 24|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.||Percentage of subjects|||Number
723230|NCT00329420|Secondary|Percentage of Subjects Achieving Remission at Week 20|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.||Percentage of subjects|||Number
723231|NCT00329420|Secondary|Percentage of Subjects Achieving Remission at Week 16|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.||Percentage of subjects|||Number
723232|NCT00329420|Secondary|Percentage of Subjects Achieving Remission at Week 14|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.||Percentage of subjects|||Number
723233|NCT00329420|Secondary|Percentage of Subjects Achieving Remission at Week 12|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.||Percentage of subjects|||Number
723234|NCT00329420|Secondary|Percentage of Subjects Achieving Remission at Week 10|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.||Percentage of subjects|||Number
723235|NCT00329420|Secondary|Percentage of Subjects Achieving Remission at Week 8|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.||Percentage of subjects|||Number
723581|NCT00324649|Secondary|Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL)|Change = Week 48 value minus baseline value.|Baseline to Week 48|Treated participants. Missing values were excluded.||mg/dL||Inter-Quartile Range|Median
723236|NCT00329420|Secondary|Percentage of Crohn's Disease Activity Index (CDAI) Responders at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)|Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. This also details withdrawal or rescue therapy being counted as non-response in a study from that time onwards in that study.||Percentage of subjects|||Number
723237|NCT00329420|Secondary|Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 32|Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. This also details withdrawal or rescue therapy being counted as non-response in a study from that time onwards in that study.||Percentage of subjects|||Number
723238|NCT00329420|Secondary|Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 28|Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. This also details withdrawal or rescue therapy being counted as non-response in a study from that time onwards in that study.||Percentage of subjects|||Number
723239|NCT00329420|Secondary|Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 24|Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. This also details withdrawal or rescue therapy being counted as non-response in a study from that time onwards in that study.||Percentage of subjects|||Number
723240|NCT00329420|Secondary|Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 20|Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. This also details withdrawal or rescue therapy being counted as non-response in a study from that time onwards in that study.||Percentage of subjects|||Number
723241|NCT00329420|Secondary|Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 16|Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. This also details withdrawal or rescue therapy being counted as non-response in a study from that time onwards in that study.||Percentage of subjects|||Number
723242|NCT00329420|Secondary|Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 14|Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. This also details withdrawal or rescue therapy being counted as non-response in a study from that time onwards in that study.||Percentage of subjects|||Number
723284|NCT00329550|Secondary|C-Reactive Protein (CRP) Level at Week 12||Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||mg/L||Full Range|Geometric Mean
723243|NCT00329420|Secondary|Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 12|Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. This also details withdrawal or rescue therapy being counted as non-response in a study from that time onwards in that study.||Percentage of subjects|||Number
723244|NCT00329420|Secondary|Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 10|Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. This also details withdrawal or rescue therapy being counted as non-response in a study from that time onwards in that study.||Percentage of subjects|||Number
723245|NCT00329420|Secondary|Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 8|Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. This also details withdrawal or rescue therapy being counted as non-response in a study from that time onwards in that study.||Percentage of subjects|||Number
723246|NCT00329420|Secondary|Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. All those in this subgroup with data are included in this summary.||score on a scale||Standard Deviation|Mean
723247|NCT00329420|Secondary|Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 34|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. All those in this subgroup with data are included in this summary.||score on a scale||Standard Deviation|Mean
723248|NCT00329420|Secondary|Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 32|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. All those in this subgroup with data are included in this summary.||score on a scale||Standard Deviation|Mean
723249|NCT00329420|Secondary|Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 28|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. All those in this subgroup with data are included in this summary.||score on a scale||Standard Deviation|Mean
723250|NCT00329420|Secondary|Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 24|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. All those in this subgroup with data are included in this summary.||score on a scale||Standard Deviation|Mean
723251|NCT00329420|Secondary|Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 20|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. All those in this subgroup with data are included in this summary.||score on a scale||Standard Deviation|Mean
723252|NCT00329420|Secondary|Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 16|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. All those in this subgroup with data are included in this summary.||score on a scale||Standard Deviation|Mean
723253|NCT00329420|Secondary|Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 14|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. All those in this subgroup with data are included in this summary.||score on a scale||Standard Deviation|Mean
723254|NCT00329420|Secondary|Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 12|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. All those in this subgroup with data are included in this summary.||score on a scale||Standard Deviation|Mean
723255|NCT00329420|Secondary|Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 10|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. All those in this subgroup with data are included in this summary.||score on a scale||Standard Deviation|Mean
723256|NCT00329420|Secondary|Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 8|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. All those in this subgroup with data are included in this summary.||score on a scale||Standard Deviation|Mean
723257|NCT00329420|Primary|Percentage of Crohn’s Disease Activity Index (CDAI) Responders at Week 34|Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.|Non-responders at Week 6 of main study C87037 (NCT00291668) could enter this extension study, C87048 (NCT00329420). This summary is based on the 26 subjects in the Full Analysis Set (FAS) Population who responded to re-induction at Week 14. Subject withdrawal or use of rescue therapy is counted as non-response from that time onwards in that study.||Percentage of subjects|||Number
723258|NCT00329433|Secondary|The Incidence of Bleeding in Each Group.||Up to 30 days after surgery||||||
723259|NCT00329433|Secondary|The Incidence of DVTs in Each Group.||7 days after surgery||||||
723260|NCT00329433|Primary|The Primary Outcome Measure Was the Number of Participants With New Heparin Platelet Factor 4 (HIT Positive) Antibodies in Each Group Within 30 Days Following Surgery.|Blood samples were collected and tested in singlet for the presence of PF4/heparin antibodies. Samples were collected for each participant on PDD (Post-study Drug initiation Day) 2, PDD 7 or at hospital discharge, and at 30 days post surgery.|30 days after surgery|Intent-to-treat analysis was performed according to initial group assignment.||participants|||Number
723261|NCT00329524|Secondary|Difference in Visual Analog Rating of Tinnitus (VAR)Following Active and Sham Tx|Rating of tinnitus loudness using a scale of 0-100 for|immediately following active and sham TMS|||analog rating||Standard Deviation|Mean
723262|NCT00329524|Secondary|Psychomotor Vigilance|Change in simple auditory reaction time after treatment|Immediately after treatment|per protocol||milliseconds||Standard Deviation|Mean
723264|NCT00329550|Post-Hoc|Number of Subjects With Disease Progression|"Disease progression is defined as:
an increase from Week 6 of ≥100 points in Crohn’s Disease Activity Index (CDAI) score and CDAI >175 points for at least 2 consecutive visits,
use of rescue therapy, or,
subject withdrawal from the study."|Week 6 to Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 6' is the last visit in the double-blind main study and 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of Study C87037 (NCT00291668) could enter this extension study, C87047 (NCT00329550). As it was not possible to calculate the time to disease progression (outcome measure 22) due to the very small number of subjects meeting this definition, the post-hoc outcome of number of subjects with disease progression is presented here.||subjects|||Number
723265|NCT00329550|Secondary|Percentage of Subjects at Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) Achieving a Reduction in Crohn’s Disease Activity Index (CDAI) Score of ≥70 Points From Week 0|CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.||Percentage of subjects|||Number
723266|NCT00329550|Secondary|Percentage of Subjects at Week 26 Achieving a Reduction in Crohn’s Disease Activity Index (CDAI) Score of ≥70 Points From Week 0|CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.||Percentage of subjects|||Number
723267|NCT00329550|Secondary|Percentage of Subjects at Week 24 Achieving a Reduction in Crohn’s Disease Activity Index (CDAI) Score of ≥70 Points From Week 0|CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.||Percentage of subjects|||Number
723268|NCT00329550|Secondary|Percentage of Subjects at Week 20 Achieving a Reduction in Crohn’s Disease Activity Index (CDAI) Score of ≥70 Points From Week 0|CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.||Percentage of subjects|||Number
723269|NCT00329550|Secondary|Percentage of Subjects at Week 16 Achieving a Reduction in Crohn’s Disease Activity Index (CDAI) Score of ≥70 Points From Week 0|CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.||Percentage of subjects|||Number
723270|NCT00329550|Secondary|Percentage of Subjects at Week 12 Achieving a Reduction in Crohn’s Disease Activity Index (CDAI) Score of ≥70 Points From Week 0|CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.||Percentage of subjects|||Number
723271|NCT00329550|Secondary|Percentage of Subjects at Week 8 Achieving a Reduction in Crohn’s Disease Activity Index (CDAI) Score of ≥70 Points From Week 0|CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.||Percentage of subjects|||Number
723272|NCT00329550|Secondary|Ratio of C-Reactive Protein (CRP) Level at Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) to Week 0||Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||ratio||Full Range|Geometric Mean
723273|NCT00329550|Secondary|Ratio of C-Reactive Protein (CRP) Level at Week 26 to Week 0||Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||ratio||Full Range|Geometric Mean
723274|NCT00329550|Secondary|Ratio of C-Reactive Protein (CRP) Level at Week 24 to Week 0||Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||ratio||Full Range|Geometric Mean
723275|NCT00329550|Secondary|Ratio of C-Reactive Protein (CRP) Level at Week 20 to Week 0||Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||ratio||Full Range|Geometric Mean
723276|NCT00329550|Secondary|Ratio of C-Reactive Protein (CRP) Level at Week 16 to Week 0||Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||ratio||Full Range|Geometric Mean
723277|NCT00329550|Secondary|Ratio of C-Reactive Protein (CRP) Level at Week 12 to Week 0||Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||ratio||Full Range|Geometric Mean
723278|NCT00329550|Secondary|Ratio of C-Reactive Protein (CRP) Level at Week 8 to Week 0||Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy have been set to missing in that study. [Week 8 is the start of Study C87047].||ratio||Full Range|Geometric Mean
723279|NCT00329550|Secondary|C-Reactive Protein (CRP) Level at Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals)||Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||mg/L||Full Range|Geometric Mean
723280|NCT00329550|Secondary|C-Reactive Protein (CRP) Level at Week 26||Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||mg/L||Full Range|Geometric Mean
723281|NCT00329550|Secondary|C-Reactive Protein (CRP) Level at Week 24||Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||mg/L||Full Range|Geometric Mean
723282|NCT00329550|Secondary|C-Reactive Protein (CRP) Level at Week 20||Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||mg/L||Full Range|Geometric Mean
723283|NCT00329550|Secondary|C-Reactive Protein (CRP) Level at Week 16||Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||mg/L||Full Range|Geometric Mean
723285|NCT00329550|Secondary|C-Reactive Protein (CRP) Level at Week 8||Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at this time-point are included. Data collected after receipt of rescue therapy have been set to missing in that study. [Week 8 is the start of Study C87047].||mg/L||Full Range|Geometric Mean
723286|NCT00329550|Secondary|C-Reactive Protein (CRP) Level at Week 0||Week 0 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 0' is the Baseline visit in the double-blind main study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||mg/L||Full Range|Geometric Mean
723287|NCT00329550|Secondary|Change From Week 0 to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score|The Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723288|NCT00329550|Secondary|Change From Week 0 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score|The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723289|NCT00329550|Secondary|Change From Week 0 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score|The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723290|NCT00329550|Secondary|Change From Week 0 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score|The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723291|NCT00329550|Secondary|Change From Week 0 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score|The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723292|NCT00329550|Secondary|Change From Week 0 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score|The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723293|NCT00329550|Secondary|Change From Week 0 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score|The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy have been set to missing in that study. [Week 8 is the start of Study C87047].||score on a scale||Standard Deviation|Mean
723407|NCT00330174|Secondary|Liebowitz Social Anxiety Scale|The LSAS is a 24-item semi-structured clinician-administered instrument that assesses social anxiety through the evaluation of fear and avoidance of different social and performance situations. There are two subscales (avoidance and fear), with scores ranging from 0-72; Total score for instrument ranges from 0-144. This study only reports on total score. Higher scores reflect greater anxiety symptoms.|12 weeks|||units on a scale||Standard Error|Mean
723294|NCT00329550|Secondary|Change From Week 0 to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score|The Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723295|NCT00329550|Secondary|Change From Week 0 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score|The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723296|NCT00329550|Secondary|Change From Week 0 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score|The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723297|NCT00329550|Secondary|Change From Week 0 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score|The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723298|NCT00329550|Secondary|Change From Week 0 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score|The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723299|NCT00329550|Secondary|Change From Week 0 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score|The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723300|NCT00329550|Secondary|Change From Week 0 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score|The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy have been set to missing in that study. [Week 8 is the start of Study C87047].||score on a scale||Standard Deviation|Mean
723301|NCT00329550|Secondary|Change From Week 0 to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score|The Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723390|NCT00329901|Secondary|Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When Tdap is Concomitantly Administered With Saline Placebo|The number of subjects reporting solicited local and systemic reactions following concomitant administration of MenACWY-CRM vaccine and Tdap vaccine as compared to when Tdap was concomitantly administered with saline placebo|Day 1-7 after any vaccination|Analysis was done on the safety population||Participants|||Number
723302|NCT00329550|Secondary|Change From Week 0 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score|The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723303|NCT00329550|Secondary|Change From Week 0 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score|The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723304|NCT00329550|Secondary|Change From Week 0 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score|The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723305|NCT00329550|Secondary|Change From Week 0 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score|The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723306|NCT00329550|Secondary|Change From Week 0 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score|The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723307|NCT00329550|Secondary|Change From Week 0 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score|The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy have been set to missing in that study. [Week 8 is the start of Study C87047].||score on a scale||Standard Deviation|Mean
723308|NCT00329550|Secondary|Change From Week 0 to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score|The Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723309|NCT00329550|Secondary|Change From Week 0 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score|The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723310|NCT00329550|Secondary|Change From Week 0 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score|The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723311|NCT00329550|Secondary|Change From Week 0 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score|The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723312|NCT00329550|Secondary|Change From Week 0 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score|The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723313|NCT00329550|Secondary|Change From Week 0 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score|The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723314|NCT00329550|Secondary|Change From Week 0 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score|The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy have been set to missing in that study. [Week 8 is the start of Study C87047].||score on a scale||Standard Deviation|Mean
723315|NCT00329550|Secondary|Change From Week 0 to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score|The Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723316|NCT00329550|Secondary|Change From Week 0 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score|The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723317|NCT00329550|Secondary|Change From Week 0 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score|The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723318|NCT00329550|Secondary|Change From Week 0 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score|The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723319|NCT00329550|Secondary|Change From Week 0 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score|The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723320|NCT00329550|Secondary|Change From Week 0 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score|The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723321|NCT00329550|Secondary|Change From Week 0 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score|The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy have been set to missing in that study. [Week 8 is the start of Study C87047].||score on a scale||Standard Deviation|Mean
723322|NCT00329550|Secondary|Time to Disease Progression|"Time to disease progression is defined as the earliest of:
time to an increase from Week 6 of ≥100 points in Crohn’s Disease Activity Index (CDAI) score and CDAI >175 points for at least 2 consecutive visits,
time to use of rescue therapy, or,
time to subject withdrawal from the study."|Week 6 to Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 6' is the last visit in the double-blind main study and 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of Study C87037 (NCT00291668) could enter this extension study C87047 (NCT00329550). As so few subjects experienced disease progression in this study it was not possible to calculate the median time to disease progression. Please see post-hoc outcome measure 80 where the number of subjects with disease progression is presented.|||||
723323|NCT00329550|Secondary|Percentage of Subjects Achieving Remission at Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals)|The Crohn’s Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn’s disease. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.||Percentage of subjects|||Number
723324|NCT00329550|Secondary|Percentage of Subjects Achieving Remission at Week 26|The Crohn’s Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn’s disease. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.||Percentage of subjects|||Number
723325|NCT00329550|Secondary|Percentage of Subjects Achieving Remission at Week 24|The Crohn’s Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn’s disease. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.||Percentage of subjects|||Number
723326|NCT00329550|Secondary|Percentage of Subjects Achieving Remission at Week 20|The Crohn’s Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn’s disease. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.||Percentage of subjects|||Number
723327|NCT00329550|Secondary|Percentage of Subjects Achieving Remission at Week 16|The Crohn’s Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn’s disease. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.||Percentage of subjects|||Number
723328|NCT00329550|Secondary|Percentage of Subjects Achieving Remission at Week 12|The Crohn’s Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn’s disease. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.||Percentage of subjects|||Number
723329|NCT00329550|Secondary|Percentage of Subjects Achieving Remission at Week 8|The Crohn’s Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn’s disease. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.||Percentage of subjects|||Number
723330|NCT00329550|Secondary|Percentage of Crohn's Disease Activity Index (CDAI) Responders at Last Visit [Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals]|CDAI responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.||Percentage of subjects|||Number
723331|NCT00329550|Secondary|Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 24|CDAI responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.||Percentage of subjects|||Number
723332|NCT00329550|Secondary|Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 20|CDAI responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.||Percentage of subjects|||Number
723333|NCT00329550|Secondary|Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 16|CDAI responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.||Percentage of subjects|||Number
723334|NCT00329550|Secondary|Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 12|CDAI responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.||Percentage of subjects|||Number
723335|NCT00329550|Secondary|Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 8|CDAI responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.||Percentage of subjects|||Number
723336|NCT00329550|Secondary|Change From Week 0 in Crohn’s Disease Activity Index (CDAI) Score at Last Visit [Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals]|CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723337|NCT00329550|Secondary|Change From Week 0 in Crohn’s Disease Activity Index (CDAI) Score at Week 26|CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723338|NCT00329550|Secondary|Change From Week 0 in Crohn’s Disease Activity Index (CDAI) Score at Week 24|CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723339|NCT00329550|Secondary|Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 20|CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723340|NCT00329550|Secondary|Change From Week 0 in Crohn’s Disease Activity Index (CDAI) Score at Week 16|CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723341|NCT00329550|Secondary|Change From Week 0 in Crohn’s Disease Activity Index (CDAI) Score at Week 12|CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
723342|NCT00329550|Secondary|Change From Week 0 in Crohn’s Disease Activity Index (CDAI) Score at Week 8|CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy have been set to missing in that study. [Week 8 is the start of Study C87047].||score on a scale||Standard Deviation|Mean
723343|NCT00329550|Primary|Percentage of Crohn’s Disease Activity Index (CDAI) Responders at Week 26|CDAI responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.||Percentage of subjects|||Number
723344|NCT00329602|Post-Hoc|Post-hoc Analysis of Percentage of Participants With a Score of Much/Very Much Improved on the Clinical Global Impression-Global Improvement (CGI-I) Scale at Weeks 12 and 26, Exploring the Impact of Center Group on Treatment Effect|A post-hoc analysis of CGI-I, exploring the variation in treatment effects across center groups by excluding the same two center groups as in the IRLS post-hoc analysis, was conducted. Centers were grouped into five center groups.|Weeks 12 and 26|ITT Population excluding the same two center groups as in the IRLS post-hoc analysis. Analysis is based on the observed cases for each visit.||Number of responders|||Number
723345|NCT00329602|Post-Hoc|Post-hoc Analysis of Mean Change From Baseline in the International Restless Legs Syndrome (IRLS) Rating Scale Total Score at Week 12 and Week 26, Exploring the Impact of Center Group on Treatment Effect|A post-hoc analysis of the primary outcome measure, exploring the variation in treatment effects across center groups by excluding those with the most extreme treatment effects, was conducted. Centers were grouped into five center groups.|Baseline and Weeks 12 and 26|ITT Population excluding the two center groups with the most extreme treatment effects. Analysis is based on the observed cases for each visit.||Points on a scale||Standard Error|Least Squares Mean
723346|NCT00329602|Secondary|Mean Change From Baseline in the IRLS Rating Scale Total Score at Week 67|A 10-item, participant-reported scale covering different symptoms of the condition. Each item is scored from 0 to 4, with 0 representing the absence of a problem and 4 reflecting a very severe problem. The best and worst possible scores are 0 and 40, respectively. The primary assessment was made by calculating the difference in the average score obtained at Baseline with score at Week 67.|Baseline and Week 67|Open-Label ITT Population: all participants who were enrolled into the Open-Label Phase of the study, received at least one dose of Open-Label study medication, and had a baseline IRLS total score and on-treatment IRLS assessment. Analysis is based on the observed cases for each visit.||points on a scale||Standard Deviation|Mean
723347|NCT00329602|Primary|Number of Participants With Clinically Meaningful Augmentation and Early Morning Rebound (EMR) Cases|Clinically meaningful augmentation and early morning rebound (EMR) were assessed and confirmed by an independent Adjudication Board. EMR describes the development of RLS symptoms during the early morning, following therapeutic intervention. EMR is differentiated from augmentation, in which the earlier onset of symptoms occurs in the evening.|During 15-month study duration at scheduled (Weeks 16, 20, 26, or early withdrawal for DB phase; Weeks 39, 47, 55, 63, 67, or early withdrawal for the OL phase) and unscheduled (26-week DB phase and 40-week OL phase) visits|Safety Population: all participants who received at least one dose of study medication||participants|||Number
723348|NCT00329602|Secondary|Number of Participants With a Score of Much/Very Much Improved on the CGI-I Scale at Week 67|The CGI-I is a psychometric instrument that is used to measure general clinical status in a variety of disease states. The CGI-I allows the investigator to rate the participant's global improvement or worsening compared with the condition at Baseline (Day 0). The scale is rated from 1-7 (1 = very much improved; 7 = very much worse). Typically, a participant with a score of 1 or 2 (much improved) is considered a responder.|Week 67|Open-Label (OL) ITT Population: all participants who were enrolled into the OL Phase of the study, received at least one dose of OL study medication, and had a baseline IRLS total score and on-treatment IRLS assessment. Data are presented for participants still in the study and assessed at Week 26, which is less than those randomized at baseline.||participants|||Number
723349|NCT00329602|Secondary|Median Time to First CGI-I Response of Much/Very Much Improved During the Double-blind Phase|The median time to first CGI-I response of much/very much improved was calculated. The CGI-I is a psychometric instrument that is used to measure general clinical status in a variety of disease states. The CGI-I allows the investigator to rate the participant's global improvement or worsening compared with the condition at Baseline (Day 0). The scale is rated from 1-7 (1 = very much improved; 7 = very much worse). Typically, a participant with a score of 1 or 2 (much improved) is considered a responder.|Baseline to Week 26|Intention-to-Treat (ITT) Population: all randomised participants who received at least one dose of study medication, and for whom at least one valid post-baseline efficacy assessment was available||days||95% Confidence Interval|Median
723350|NCT00329602|Secondary|Number of Participants Rated as Normal or Borderline Ill on the CGI Severity of Illness (CGI-S) Scale at Week 26|The CGI-S scale is a psychometric instrument that is used to measure general clinical status in a variety of disease states. The CGI-S allows the investigator to rate the severity of the participant's illness considering their total clinical experience with the subject population being studied and on all information available at the time of rating. The scale is rated from 1-7 (1 = normal, not at all ill; 2 = borderline ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severly ill; 7 = among the most extremely ill participants).|Week 26|Intention-to-Treat (ITT) Population: all randomised participants who received at least one dose of study medication, and for whom at least one valid post-baseline efficacy assessment was available. Data are presented for the participants still in the study and assessed at Week 26, which is less than those randomised at baseline.||participants|||Number
723351|NCT00329602|Secondary|Number of Participants Withdrawing Due to Lack of Efficacy During the First 26 Weeks of the Study|Lack of efficacy is defined as up to a 10% improvement in the IRLS Rating Scale total score from the participant's Baseline value and at least 12 weeks of treatment during the double-blind phase.|Baseline to Week 26|Intention-to-Treat (ITT) Population: all randomised participants who received at least one dose of study medication, and for whom at least one valid post-baseline efficacy assessment was available||participants|||Number
723352|NCT00329602|Secondary|Percentage of Participants With a Score of Much/Very Much Improved on the Clinical Global Impression-Global Improvement (CGI-I) Scale at Weeks 1, 12 and 26|The CGI-I is a psychometric instrument that is used to measure general clinical status in a variety of disease states. The CGI-I allows the investigator to rate the participant's global improvement or worsening compared with the condition at Baseline (Day 0). The scale is rated from 1-7 (1 = very much improved; 7 = very much worse). Typically, a participant with a score of 1 or 2 (much improved) is considered a responder.|Weeks 1, 12 and 26|Intention-to-Treat (ITT) Population. Analysis is based on the observed cases for each visit.||percentage of participants|||Number
723353|NCT00329602|Secondary|Change From Baseline in the Domains of the MOS 36-item Short Form Health Survey (SF-36) at Weeks 12 and 26|The MOS SF-36 is a generic QoL instrument measuring functional status and well-being. Positive change from baseline for all domains indicates improvement. For all MOS SF-36 domains, the minimum and maximum scores are 0 and 100, respectively, for the transformed scale. Scores were adjusted for baseline domain score, treatment group, visit, visit by treatment interaction, and center group.|Baseline and Weeks 12 and 26|Intention-to-Treat (ITT) Population: all randomised participants who received at least one dose of study medication, and for whom at least one valid post-baseline efficacy assessment was available. Analysis is based on the observed cases for each visit.||points on a scale||Standard Error|Least Squares Mean
723354|NCT00329602|Secondary|Change From Baseline in the Johns Hopkins RLS Quality of Life (RLS QoL) Questionnaire Overall Life Impact Score at Weeks 12 and 26|The Johns Hopkins RLS QoL Questionnaire is a disease-specific instrument that assesses the impact of RLS on the daily life, emotional well-being, social life, and work life of participants. The overall life impact score for the John Hopkins RLS QoL scale ranges from a lowest possible score of 0 to a highest possible score of 100. Higher scores represent better quality of life. Scores were adjusted for baseline RLS Quality of Life score, treatment group, visit, visit by treatment interaction, and center group.|Baseline and Weeks 12 and 26|Intention-to-Treat (ITT) Population: all randomised participants who received at least one dose of study medication, and for whom at least one valid post-baseline efficacy assessment was available. Analysis is based on the observed cases for each visit.||points on a scale||Standard Error|Least Squares Mean
723355|NCT00329602|Secondary|Change From Baseline in Sleep Quantity, a Domain of the 12-item Medical Outcomes Study (MOS-12) Sleep Scale, at Weeks 12 and 26|The MOS-12 Sleep Scale is a comprehensive battery, which measures specific aspects of sleep in participants that may have varying co-morbidities, and, as a result, is appropriate for a medically diverse participant population.Scores were adjusted for baseline MOS sleep scale domain value, treatment group, visit, visit by treatment interaction, and center group.|Baseline and Weeks 12 and 26|Intention-to-Treat (ITT) Population: all randomised participants who received at least one dose of study medication, and for whom at least one valid post-baseline efficacy assessment was available. Analysis is based on the observed cases for each visit.||hours||Standard Error|Least Squares Mean
723356|NCT00329602|Secondary|Change From Baseline in the Domains of the 12-item Medical Outcomes Study (MOS-12) Sleep Scale at Weeks 12 and 26|The MOS-12 Sleep Scale is a comprehensive battery, which measures specific aspects of sleep in participants that may have varying co-morbidities, and, as a result, is appropriate for a medically diverse participant population. Domain values are presented on a 0-100 scale, where a higher score means a greater degree of the attribute implied by the scale name. Scores were adjusted for baseline MOS sleep scale domain value, treatment group, visit, visit by treatment interaction, and center group.|Baseline and Weeks 12 and 26|Intention-to-Treat (ITT) Population: all randomised participants who received at least one dose of study medication, and for whom at least one valid post-baseline efficacy assessment was available. Analysis is based on the observed cases for each visit.||points on a scale||Standard Error|Least Squares Mean
723357|NCT00329602|Secondary|Mean Change From Baseline in the International RLS (IRLS) Rating Scale Total Score at Weeks 1, 4, 8, 16, and 20|A 10-item, participant-reported scale covering different RLS symptoms. Each item is scored from 0 to 4; 0 represents the absence of a problem and 4 reflects a very severe problem. The best and worst possible scores are 0 and 40, respectively; higher scores represent a greater severity of symptoms. The primary assessment from this study was made by calculating the difference in the average score obtained at Baseline with scores at Weeks 1, 4, 8, 16, and 20. Scores were adjusted for baseline IRLS total score, treatment group, visit, visit by treatment group interaction, and center group.|Baseline and Weeks 1, 4, 8, 16, and 20|Intention-to-Treat (ITT) Population: all randomised participants who received at least one dose of study medication, and for whom at least one valid post-baseline efficacy assessment was available. Analysis is based on the observed cases for each visit.||points on a scale||Standard Error|Least Squares Mean
723358|NCT00329602|Primary|Mean Change From Baseline in the International Restless Legs Syndrome (IRLS) Rating Scale Total Score at Week 12 and Week 26|A 10-item, participant-reported scale covering different symptoms of the condition. Each item is scored from 0 to 4; 0 represents the absence of a problem and 4 reflects a very severe problem. The best and worst possible scores are 0 and 40, respectively; higher scores represent a greater severity of symptoms. A negative change from baseline indicates improvement, and a negative treatment difference indicates a benefit of Ropinirole IR over placebo. The primary assessment was made by calculating the difference in the average score obtained at Baseline with scores at Week 12 and then Week 26.|Baseline and Weeks 12 and 26|Intention-to-Treat (ITT) Population: all randomised participants who received at least one dose of study medication, and for whom at least one valid post-baseline efficacy assessment was available. Analysis is based on the observed cases for each visit.||points on a scale||Standard Error|Least Squares Mean
723359|NCT00329641|Secondary|Toxicity|Number of patients with Grade 3-5 adverse events that are related to study drug by given type of adverse event|Weekly during the first cycle of therapy, then prior to each cycle (one cycle = 3 weeks)|Eligible patients who started therapy||Participants with a given type of AE|||Number
723360|NCT00329641|Secondary|6-month Progression-free Survival|Measured from the date of registration to the first of progression or death due to any cause with patients last known to be alive and progression-free censored at the date of last contact|Every 6 weeks for the first 8 cycles of therapy, and then every 9 weeks until disease progression for up to 3 years after registration or until death|||Percent of population||95% Confidence Interval|Number
723361|NCT00329641|Secondary|One-year Overall Survival|Measured from date of registration to study until death due to any caused with observations last known to be alive censored at the date of last contact|Every 6-9 weeks until progression, after progression every six months for first two years and annually thereafter up to 3 for up to 3 years after registration or until death|Eligible patients who received some treatment||Percentage of population||95% Confidence Interval|Number
723362|NCT00329641|Primary|Response Rate (Complete and Partial Response)|Complete response corresponds to complete disappearance of all measurable and non-measurable lesions with no new lesions. Partial response corresponds to greater than or equal to 30ﬁ decrease of sum of longest diameter of all target measurable lesions with no new lesion and non unequivocal progression of non-measurable disease.|Every 6 weeks for the first 8 cycles of therapy, then every three cycles (9 weeks) until progression|Eligible patients who received some treatment||participants|||Number
723363|NCT00329719|Secondary|Progression-free Survival|Kaplan-Meier survival curves will be used to estimate progression-time distributions.|Time from study registration to date of disease progression or last follow-up, assessed up to 5 years|||months||95% Confidence Interval|Median
723364|NCT00329719|Secondary|Objective Response, as Determined by a Neurological Exam, MRI, and/or CT Measurement|The proportion of patients in each response category will be summarized and 90% confidence intervals calculated assuming that the incidence of response is binomially distributed.|Up to 5 years|||proportion of patients||90% Confidence Interval|Number
723365|NCT00329719|Secondary|Overall Survival|The overall survival distribution will be estimated using the method of Kaplan-Meier.|From start of study registration to death due to any cause or until last follow-up, up to 5 years|||months||95% Confidence Interval|Median
723391|NCT00329901|Secondary|Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When MenACWY-CRM is Concomitantly Administered With Saline Placebo|The number of subjects reporting solicited local and systemic reactions following concomitant administration of MenACWY-CRM vaccine and Tdap vaccine as compared to when MenACWY-CRM vaccine was concomitantly administered with saline placebo.|Day 1-7 after any vaccination|Analysis was done on the safety population||Participants|||Number
723427|NCT00330460|Secondary|Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|12 months|||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
723366|NCT00329719|Primary|Progression-free Survival|"The primary endpoint is the proportion of patients alive and progression-free 6 months after study treatment initiation.
If more than 41 evaluable patients are accrued in group 1 or group 3, the additional patients will not be used to evaluate the decision rule for that group or otherwise used in any decision-making processes. However, they will be included in the final point and confidence interval estimates for that group.
The ‘success’ probability, i.e., 6-month progression-free survival percentage, for each of group 1 and group 3 will be estimated as the number of evaluable patients still alive at 6 months divided by the total number of evaluable patients followed for at least 6 months. Ninety-five percent confidence intervals for the ‘success’ probability will be calculated according to the approach of Duffy and Santner.
Progression is defined as a 25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions."|At 6 months|||Proportion of Successes||95% Confidence Interval|Number
723367|NCT00329732|Secondary|Percentage of Subjects Achieving Resolution of Associated Symptoms of Nausea, Vomiting, Photophobia, Phonophobia, Osmophobia, Allodynia Measured During the First 30 Minutes Post-injection, Active Drug Versus Placebo;||30 minutes||||||
723368|NCT00329732|Secondary|Percentage of Subjects Achieving a Significant Change on a 100mm Visual Analogue Scale (VAS) at 30 Minutes Post-injection, Active Drug Versus Placebo. Significant Change is Defined as a Greater Than or Equal to 2cm Change.||30 minutes||||||
723369|NCT00329732|Secondary|Secondary Measures Include:Percentage of Subjects Achieving a Significant Change on a 10 Point Pain Scale at 30 Minutes Post-injection, Active Drug Versus Placebo;||30 minutes||||||
723370|NCT00329732|Primary|Percentage of Patients Experiencing Significant Change on a 4 Point Pain Scale at 30 Minutes Post-injection, Active Drug Versus Placebo. Significant Change is Defined as a Change on the 4 Point Pain Scale From Moderate or Severe to Mild. No Pain Equals 0.||30 minutes|No analysis was done. Study was terminated.|||||
723371|NCT00329745|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|From the end of the primary study up to Year 3|||subjects|||Number
723372|NCT00329745|Primary|Number of Subjects With Severe Rotavirus Gastroenteritis (RV GE) Caused by the Circulating Wild-type Rotavirus Strains|"Severe RV GE is an episode of severe GE in which rotavirus other than vaccine strain was identified in a GE stool sample.
Note that this outcome measure is secondary in the study protocol. We have reported it here as primary outcome measure, since none of the primary outcome measures in the study protocol pertain to the time point (Year 3 follow-up) presented in this summary."|From Year 2 up to Year 3|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy.||subjects|||Number
723373|NCT00329771|Primary|Proportion of Subjects With Allodynia During a Migraine Attack|Brush allodynia (discomfort with normal sensation) measured at pre-specified sites on the head, neck and forearms using a 100 mm visual analog scale (VAS).|allodynia assessed within 4 hours from onset of migraine head pain|Participants who completed allodynia test||participants|||Number
723374|NCT00329784|Secondary|Number of Participants With Food Specific IgE Greater Than or Equal to 0.35 kU/L|At 60 months of age, participants were assessed for potential allergy to selected food allergens. Participants were considered to have a specific food sensitivity if a blood draw showed specific IgE levels greater than or equal to 0.35 kU/L for selected ingested allergens.|60 months|Intent-to-treat with data available||Participants|||Count of Participants
723375|NCT00329784|Secondary|Number of Participants With Specific Skin Prick Test Greater Than or Equal to 3mm|At 60 months of age, participants were assessed for potential allergy to selected food allergens. Participants were considered to have a specific sensitivity if a skin prick containing the allergen produced a wheal size measuring greater than or equal to 3 mm.|60 months|Intent-to-treat with data available||Participants|||Count of Participants
723376|NCT00329784|Secondary|Number of Participants With Rhinitis at 60 Months|At 60 months of age, participants were assessed for rhinitis. Two types of rhinitis were assessed, perennial rhinoconjunctivitis and seasonal rhinoconjunctivitis. Participants were considered to have either type of rhinitis if they showed a sensitization to the allergen and clinical history of rhinoconjunctivitis symptoms experienced either when exposed to the relevant allergen (perennial) or during the relevant season (seasonal).|60 months|Intent-to-treat with rhinitis data available||Participants|||Count of Participants
723377|NCT00329784|Secondary|Number of Participants With Asthma at 60 Months|At 60 months of age, participants were assessed for asthma. Participants were considered to have asthma if they had a history of cough, wheeze, or shortness of breath that (1) was responsive to therapy with bronchodilators on two or more occasions in the previous 24 months, (2) required one visit to a physician in the previous 24 months, or (3) occurred during the night, during early morning, or upon exercising in the intervals between exacerbations at any time in the previous 12 months.|60 months|Intent-to-treat with asthma data available||Participants|||Count of Participants
723378|NCT00329784|Secondary|SCORAD at 60 Months|At 60 months of age, participants were assessed for eczema using a modified Scoring Atopic Dermatitis System (SCORAD). This measure was used to detect eczema in children who may not have had access to topical anti-inflammatory medications or whose parents cannot recall or report the severity of their child’s eczema. Eczema is any type of dermatitis or inflammation of the skin. Atopic dermatitis is the most severe and chronic of all types of eczema. The range of the SCORAD is 0-103. A score of 0 indicates no eczema, scores between 0 and 15 indicate mild eczema, scores between 15 and 40 indicate moderate eczema, and scores greater than 40 indicate severe eczema.|60 months|Intent-to-treat with SCORAD data available||units on a scale||Standard Deviation|Mean
723392|NCT00329901|Secondary|Percentage of Subjects With hSBA Seroresponse, When MenACWY-CRM is Concomitantly Administered With Tdap Compared to MenACWY-CRM Given Concomitantly With Saline Placebo|"The percentage of subjects showing an hSBA seroresponse against N.meningitidis serogroups A,C,W and Y, following concomitant administration of MenACWY-CRM vaccine with Tdap vaccine as compared to when MenACWY-CRM was given concomitantly with saline placebo.
Seroresponse to MenACWY-CRM is defined as a pre-vaccination hSBA titer < 1:4 to a post-vaccination hSBA titer of ≥ 1:8 or a pre-vaccination hSBA titer ≥ 1:4 to a post-vaccination titer of at least four times the baseline hSBA titer."|1 month after vaccination (Day 29)|Analysis was done on per-protocol population.||Percentages of subjects||95% Confidence Interval|Number
723379|NCT00329784|Primary|Number of Participants With Peanut Allergy at 60 Months of Age – Both Strata Combined|At 60 months of age, participants were given an oral food challenge Participants regarded as unlikely to be allergic to peanut received 5 g of peanut protein in a single dose. These participants were considered to have a peanut allergy if they experienced any type of reaction following consumption. A double-blind, placebo-controlled food challenge was offered to other participants with a total of 9.4 g of peanut protein administered in increments. These participants were considered to have a peanut allergy if at any point during the dose escalation procedure the participant had a reaction. Participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on clinical history, the results of a skin-prick test, and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have peanut allergy.|60 months|Intent-to-treat – all randomly assigned participants who were evaluable for peanut allergy at age 60 months||Participants|||Count of Participants
723380|NCT00329784|Primary|Number of Participants With Peanut Allergy at 60 Months of Age – by Skin Prick Test Stratum|At 60 months of age, participants were given an oral food challenge Participants regarded as unlikely to be allergic to peanut received 5 g of peanut protein in a single dose. These participants were considered to have a peanut allergy if they experienced any type of reaction following consumption. A double-blind, placebo-controlled food challenge was offered to other participants with a total of 9.4 g of peanut protein administered in increments. These participants were considered to have a peanut allergy if at any point during the dose escalation procedure the participant had a reaction. Participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on clinical history, the results of a skin-prick test, and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have peanut allergy.|60 months|Intent-to-treat – all randomly assigned participants who were evaluable for peanut allergy at age 60 months||Participants|||Count of Participants
723381|NCT00329836|Primary|Prevalence of Allodynia in Subjects With Cluster Headache|Allodynia (discomfort to normal sensation) was assessed by brushing at constant rate of 2 brushes/sec and pressure allodynia with Von Frei hairs. Outcome (discomfort) was measured on a 100 mm visual analogue scale.|Allodynia was assessed at the screening visit|N/A. No lost to follow-up or missing data. All enrolled subjects were analyzed||participants|||Number
723382|NCT00329849|Secondary|Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS|Safety was assessed as the number of subjects who reported local and systemic reactions and axillary temperature during day 1 to day 7 after vaccination with MenACWY-CRM or MenACWY-PS.|Day 1 to 7 postvaccination|Analysis was performed on safety dataset. Groups were sub-divided into 2 to 5 years of age and 6 to 10 years of age.||Number of subjects|||Number
723383|NCT00329849|Secondary|The hSBA Geometric Mean Titers Persisting Against Meningococcal Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS|The persistence of immune response was measured in terms of the hSBA GMTs persisting at day 181 against each of four meningococcal serogroups A, C, W and Y after vaccination with MenACWY-CRM or MenACWY-PS|Day 181|Analysis was performed on the PP dataset for persistence analysis at day 181.||Geometric Mean Titers||95% Confidence Interval|Geometric Mean
723384|NCT00329849|Secondary|Percentage of Subjects With Persisting hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS|The persistence of immune response was measured as the percentage of subjects with hSBA titers ≥1:4 and ≥1:8 against each of four meningococcal serogroups A, C, W and Y at day 181 after vaccination with MenACWY-CRM or MenACWY-PS.|Day 181|Analysis was performed on PP dataset for persistence analysis at day 181.||Percentage of subjects||95% Confidence Interval|Number
723385|NCT00329849|Secondary|The hSBA Geometric Mean Titers Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS|The immune response was measured as the hSBA geometric mean titers (GMTs) directed against each of four meningococcal serogroups A, C, W and Y at baseline (day 1) and one month(day 29) after one vaccination with MenACWY-CRM or MenACWY-PS.|Day 1 and 29|Analysis was performed on the PP dataset of primary vaccination.||Geometric Mean Titers||95% Confidence Interval|Geometric Mean
723386|NCT00329849|Secondary|Percentage of Subjects With hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS|Immunogenicity was measured as the percentage of subjects who achieved hSBA titers ≥1:4 and ≥1:8 against each of four meningococcal serogroups A, C, W and Y at baseline (day 1) and one month (day 29)after one vaccination with MenACWY-CRM or MenACWY-PS.|Day 1 and 29|Analysis was performed on the PP dataset of primary vaccination.||Percentage of subjects||95% Confidence Interval|Number
723387|NCT00329849|Primary|Number of Subjects With At Least One Severe Systemic Reaction to MenACWY-CRM or MenACWY-PS Within 7 Days Postvaccination|Safety was assessed in terms of the number of subjects who reported at least one severe systemic reaction after vaccination with MenACWY-CRM or MenACWY-PS from day 1 to day 7 after vaccination.|Day 1 to 7 postvaccination|Analysis was done on the safety set, i.e. the subjects in the exposed population who provided postvaccination safety data.||Number of subjects|||Number
723388|NCT00329849|Primary|Percentage of Subjects With hSBA Seroresponse Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS|"Immunogenicity was measured as the percentage of subjects with hSBA seroresponse, directed against each of meningococcal serogroups A, C, W and Y, evaluated by serum bactericidal assay using human complement (hSBA), one month after vaccination (day 29)with MenACWY-CRM or MenACWY-PS vaccine.
Seroresponse was defined as:
for subjects with a prevaccination hSBA titer <1:4, a postvaccination hSBA titer ≥1:8;
for subjects with a prevaccination hSBA titer ≥1:4, an increase in hSBA titer of at least four times the prevaccination titer."|1 month after vaccination (day 29)|Analysis was done on the per-protocol (PP) dataset of primary vaccination, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at one month after vaccination; and had no major protocol violations as defined in the analysis plan.||Percentage of subjects||95% Confidence Interval|Number
723389|NCT00329901|Secondary|Number of Subjects With Unsolicited Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to MenACWY-CRM or Tdap Concomitantly Administered With Saline Placebo|The number of subjects reporting any unsolicited adverse events (AEs) when Tdap is concomitantly administered with MenACWY-CRM as compared to when MenACWY-CRM vaccine or Tdap vaccine was concomitantly administered with saline placebo.|Throughout the study (Day 1 to Day 181)|This analysis was done on the safety population.||Participants|||Number
723393|NCT00329901|Secondary|Geometric Mean Ratios of hSBA Titers Against N.Meningitidis Serogroups A,C,W and Y, When MenACWY-CRM is Concomitantly Administered With Tdap Compared to MenACWY-CRM Given Concomitantly With Saline Placebo|The geometric mean ratios (GMRs-day 29/day1)of post-vaccination versus pre- vaccination hSBA titers against N.meningitidis serogroups A,C,W and Y, when MenACWY-CRM vaccine is concomitantly administered with Tdap vaccine as compared to when MenACWY-CRM was given concomitantly with saline placebo.|1 month after vaccination (Day 29)|Analysis was done on per-protocol population.||Ratios||95% Confidence Interval|Geometric Mean
723394|NCT00329901|Secondary|The hSBA Geometric Mean Titers Against N.Meningitidis Serogroups A,C,W and Y, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo|The hSBA geometric mean titers (GMTs) against N.meningitidis serogroups A,C,W and Y, at baseline and at one month, following concomitant administration of MenACWY-CRM vaccine with Tdap vaccine, as compared to when MenACWY-CRM was given concomitantly with saline placebo.|1 month after vaccination (Day 29)|Analysis was done on per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
723395|NCT00329901|Secondary|Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:4 and ≥1:8, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo|"The percentage of subjects with serum bactericidal antibody titers(hSBA) ≥ 1:4 and ≥ 1:8 against Neisseria meningitidis serogroups A,C,W and Y,following concomitant administration of MenACWY-CRM vaccine with Tdap vaccine as compared to when MenACWY-CRM was given concomitantly with saline placebo.
The serum bactericidal antibodies directed against N.meningitidis serogroup A, C, W and Y, are measured by human complement Serum Bactericidal Assay (hSBA)."|1 month after vaccination (Day 29)|Analysis was done on per-protocol population.||Percentages of subjects||95% Confidence Interval|Number
723396|NCT00329901|Secondary|Geometric Mean Ratios of Antibody Concentrations Against Diphtheria,Tetanus and Pertussis Antigens When Tdap is Administered Concomitantly With MenACWY-CRM Vaccine Compared to Tdap Given Concomitantly With Saline Placebo|The geometric mean ratios (GMRs- day 29/day 1) of post-vaccination versus pre- vaccination antibody concentrations against diptheria, tetanus and pertussis (PT, FHA and PRN) antigens following concomitant administration of Tdap vaccine with MenACWY-CRM vaccine as compared to when Tdap was given concomitantly with saline placebo.|1 month after vaccination (Day 29)|Analysis was done on per-protocol population.||Ratio||95% Confidence Interval|Geometric Mean
723397|NCT00329901|Secondary|Geometric Mean Concentrations (GMCs) of Antibodies Against Diphtheria,Tetanus and Pertussis Antigens After Concomitant Administration of Tdap With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo|The geometric mean concentrations of antibodies ≥ 0.1 IU/mL against diphtheria, tetanus and pertussis (PT, FHA and PRN) antigens in subjects, as measured by ELISA, following concomitant administration of Tdap with MenACWY-CRM as compared to when Tdap given concomitantly with saline placebo.|1 month after vaccination (Day 29)|Analysis was done on per-protocol population.||IU/mL||95% Confidence Interval|Geometric Mean
723398|NCT00329901|Secondary|Percentage of Subjects With Anti-diphtheria and Anti-tetanus Concentrations ≥ 0.1 IU/mL When Tdap is Administered Concomitantly With MenACWY-CRM Vaccine Compared to Tdap Given Concomitantly With Saline Placebo|The percentage of subjects with anti-diphtheria and anti-tetanus concentrations ≥ 0.1 IU/mL (as measured by ELISA) following concomitant administration of Tdap vaccine with MenACWY-CRM vaccine as compared to when Tdap was given concomitantly with saline placebo.|1 month after vaccination (Day 29)|Analysis was done on per-protocol population.||Percentages of subjects||95% Confidence Interval|Number
723399|NCT00329901|Primary|Percentage of Subjects With an Immune Response Against Diphtheria, Tetanus and Pertussis, When Tdap is Concomitantly Administered With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo|"To demonstrate that the immunogenicity of one injection of Tdap vaccine, concomitantly administered with MenACWY-CRM vaccine, is not inferior to that of one injection of Tdap vaccine, concomitantly administered with saline placebo, in terms of
the percentage of subjects with antibody levels against diphtheria toxin ≥ 1.0 IU/mL and against tetanus toxin ≥ 1.0 IU/mL and
the percentage of subjects with at least 4 fold increase in antibody levels against pertussis toxin (PT), filamentous hemagglutinin (FHA) and pertactin (PRN) at 1 month after immunization, as measured by enzyme linked immunosorbent assay (ELISA)."|1 month after vaccination (Day 29)|Analysis was done on the per-protocol population i.e all subjects who received all the relevant doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to unblinding||Percentages of subjects||95% Confidence Interval|Number
723400|NCT00330161|Secondary|Objective Response Rate|Percentage of participants that obtain the best objective response, stable disease.|Up to 3 years|Of the 29 patients enrolled, two patients were deemed ineligible after treatment and therefore excluded from analysis.||percentage of participants|||Number
723401|NCT00330161|Secondary|Median Survival|Median overall survival.|Up to 3 years|Of the 29 patients enrolled, two patients were deemed ineligible after treatment and therefore excluded from analysis. Of the 27 patients analyzed, one patient was censored with an outlying overall survival of 15.1 months.||months||Full Range|Median
723402|NCT00330161|Secondary|Progression-free Survival|Median time to progression was determined.|From the start of treatment to time of progression, assessed up to 3 years|Of the 29 patients enrolled, two patients were deemed ineligible after treatment and therefore excluded from analysis.||months||Full Range|Median
723403|NCT00330161|Secondary|Rate of PSA Decline|Rate of Prostate Specific Antigen (PSA) decline of greater than or equal to 50%.|Up to 3 years|No PSA declines of greater than or equal to 50% were observed, therefore the rate could not be determined.|||||
723404|NCT00330161|Secondary|Incidence of Toxicity|The percentage of eligible participants that experience grade 3 or 4 toxicities.|Up to 3 years|Of the 29 patients enrolled, 2 were deemed ineligible after treatment and therefore excluded from outcome analysis.||percentage of participants|||Number
723405|NCT00330161|Primary|Proportion of Patients Who do Not Demonstrate Disease Progression|Fisher’s Exact Test will be used.|At 6 months|The primary objective was to determine the number of patients wtih progression-free survival at 6 months. Unfortunately all eligible patients were off therapy before the 6 month time point. 13 (48%) were removed due to progression, 11 (41%) secondary to toxicity, and 3 (11%) for other reasons.|||||
723406|NCT00330174|Secondary|Hospital Anxiety and Depression Scale|This is a 14-item self report assessment that contains two subscales (depression and anxiety) with each subscale ranging from 0-21; the total score ranges from 0-42. We report total scores. Higher scores represent worse symptoms.|12 weeks|||units on a scale||Standard Error|Mean
723408|NCT00330174|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS)|This 10-item rating scale is commonly used in the European pharmacotherapy trials, and it may have benefit in assessing substance abusers, because it focuses on cognitive symptoms of depression instead of the physical symptoms, which could be due to substance use and withdrawal (Yonkers and Samson, 2000). Total scores are used; Scale range is 0-60, with higher scores reflecting more severe symptoms.|12 weeks|||units on a scale||Standard Error|Mean
723409|NCT00330174|Primary|Percent Days Drinking|Drinking was assessed using the timeline followback (TLFB), which is a calendar-based instrument used to assess drinking and other substance use on a daily basis.|12 weeks|The primary outcome measure is difference in cumulative days abstinent. Based on the meta-analysis by Mann et al (2004). A total sample of 90 participants would be able to detect a difference of 11 (+/- 18) days between acamprosate and placebo groups with 80% power, and Type 1 error rate of 0.05.||percentage of days drinking||Standard Error|Mean
723410|NCT00330343|Primary|Number of Participants With Naloxone Side Effects|incidence of nausea, vomiting, pruritus following naloxone infusion|0-48 hours after infusion begins|||participants||95% Confidence Interval|Number
723411|NCT00330382|Secondary|Combined Percentage Change From Baseline in Proteolytic Activity, Buccal-cell Erb-B2 (Neu) and Serum Levels of Neu at 6 Months||Baseline to 6 months|The participants whose data are available and complete are included in the analysis.||percentage change||95% Confidence Interval|Median
723412|NCT00330382|Secondary|Number of Participants Report at Least 1 Adverse Event During the Study|The onset of adverse event is between the randomizaiton date and off-study date|Randomized date to Off-study date, up to 21 months|||participants|||Number
723413|NCT00330382|Secondary|Relative Percent Change in Protease Activity (Delta RFU/Min/µg)|100% x (Posttreatment value - pretreatment value)/(pretreatment value)|Baseline to 6 months|The participants who have complete data are analyzed in this outcome measure.||percentage change||95% Confidence Interval|Median
723414|NCT00330382|Secondary|Relative Percent Change in Serum Neu Protein (ng/ml)|100% x (Posttreatment value - pretreatment value)/(pretreatment value)|Baseline to 6 months|The participants who have complete data are analyzed in this outcome measure.||percentage change||95% Confidence Interval|Median
723415|NCT00330382|Secondary|Relative Percent Change in Buccal-Cell Neu Protein (ng/mg)|100% x (Posttreatment value - pretreatment value)/(pretreatment value)|Baseline to 6 months|The participants who have complete data are analyzed in this outcome measure.||percentage change||95% Confidence Interval|Median
723416|NCT00330382|Secondary|Clinical Impression From Photographs|A secondary clinical response measure was bsaed on blinded, comparative judgments of pairs of photographs of the same lesion at baseline and 6 months on study. Picture pairs were assigned to album page, one pair per page, at random. Five physicians experienced with evaluation of oral mucosal tissue abnormalities, but blinded to study arm and time point, independently compared the pictures in each pair using a 7-point scale. The scale ranged from, “top photo shows a complete response relative to the bottom photo,” through, “the same degree of disease is shown by top photo and bottom photo,” to “bottom photo shows a complete response relative to the top photo.” Raw scores were transformed to account for relative position of the earlier and later photo, and averaged across the 5 reviewers. Final scores ranged from one, denoting a CR at 6 months, to 4, which indicated no change, through 7, which indicated that the 6-month photo depicted a much worse situation than the pretreatment photo.|Baseline to 6 months|The participants who have complete data are analyzed in this outcome measure.||score||Standard Deviation|Mean
723417|NCT00330382|Primary|Number of Participants by Category of Clinical Response at 6 Months|Category of clinical response was based on the magnitude of relative percent change in total lesion area. A complete response (CR) was declared if the relative percent change in total lesion area was minus 100 percent. A partial response (PR) was a relative percent decrease in total lesion area of 50% or more, without being a CR. Disease progression was a relative percent increase in total lesion area of at least 50%. Remaining cases were declared to be stable disease.|6 months|The participants who have complete data are analyzed in this outcome measure.||participants|||Number
723418|NCT00330382|Secondary|The Difference in Rated Degree of Malignancy Between Randomization and 6-month Specimen|The reviewer was blinded to study-arm assignment (drug or placebo), but not to time point of specimen. For each specimen, the reviewer marked a continuum to indicate degree of tissue abnormality. The continuum was 140 mm long, and anchored by the word ‘Normal’ on the left and ‘Malignant’ on the right. The distance from the left edge of the continuum to the reviewer's mark, in mm, was determined. For analyses, a score was formed by subtracting the pretreatment value from the 6-month value. Thus, a retreat from ‘Malignancy’ over time produces a negative score, a score of zero denotes no change, and a positive score denotes a worsening situation. Positive values indicate histologic worsening, whereas negative scores denote improvement over the 6-month study period.|Baselie to 6 months|The participants who have complete data are analyzed in this outcome measure.||score||Standard Deviation|Mean
723419|NCT00330382|Primary|Relative Percent Change in Total Lesion Area After 6 Months on Study|Relative percent change in total lesion area was defined as 100 times (area posttreatment minus area pretreatment) all divided by pretreatment area.|6 months|The participants who have complete data are analyzed in this outcome measure.||percentage change||Standard Deviation|Mean
723420|NCT00330421|Primary|Incidence of Adverse Events||Up to 1 month||||||
723421|NCT00330421|Primary|Clinical Benefit, Measured by Any Reduction in Tumor Dimensions on CT Scan as Measured by RECIST Criteria||Up to 1 month||||||
723422|NCT00330421|Primary|Clinical Benefit as Measured by 50% Reduction in IFP||Baseline to surgery||||||
723423|NCT00330421|Primary|Change in Pericyte Coverage of Endothelial Cells (Alpha-SMA)|Paired comparison made using a Wilcoxon signed rank test with one-sided type I error of 5%.|Baseline to up to 1 month post-treatment||||||
723424|NCT00330421|Primary|Change in White Blood Cell Count (WBC)|Paired comparison made using a Wilcoxon signed rank test with one-sided type I error of 5%.|Baseline to up to 1 month post-treatment||||||
723425|NCT00330421|Primary|Change in Interstitial Fluid Pressure (IFP)|Paired comparison made using a Wilcoxon signed rank test with one-sided type I error of 5%.|Baseline to up to 1 month post-treatment|IFP measurements were obtained in only 6 of 15 patients at baseline. Only 2 of these 6 patients had SD at 28 and 56 days and therefore, second IFP measurements were only obtained in those 2 patients.||mm Hg||Full Range|Mean
723426|NCT00330421|Primary|Change in Fludeoxyglucose (FDG) Uptake (Maximal Standardized Uptake Value, or SUVmax)|Paired comparison made using a Wilcoxon signed rank test with one-sided type I error of 5%.|Baseline to up to 1 month post-treatment||||||
723431|NCT00330460|Primary|Total Hip Bone Mineral Density Percent Change From Baseline at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|12 months|Randomized subjects who have a nonmissing baseline and at least 1 nonmissing postbaseline evaluation at or prior to month 12. LOCF used as imputation method.||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
723432|NCT00330564|Primary|Safety of Sunitinib Administration in Participants With Von Hippel-Lindau Syndrome (VHL)|Safety evaluation = Number of participants with treatment terminating toxicity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 3.0. Early stopping rules applied when treatment terminating toxicity occurred in the first 6 week cycle. Recurring grade 3 toxicity requires dose reduction, with no more than 2 dose reductions permitted. If no improvement after 4 weeks, patient is taken off drug and off study, and the event recorded as treatment terminating toxicity.|12 weeks|Intent to treat once the first dose was taken.||participants|||Number
723433|NCT00330564|Secondary|Number of VHL Lesion Complete + Partial Responses|Response of VHL lesions (number) evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) of Complete Response (CR): Disappearance of all target lesions, and Partial Response (PR): At least a 30% decrease in the sum of longest diameter (LD) of target lesions, reference baseline sum LD. Progressive Disease (PD): 20% increase in LD sum and Stable Disease (SD): Insufficient shrinkage to qualify for PR nor increase to qualify for PD. Degree and timing of response in affected organs evaluated in order to determine organ specific kinetics of therapy.|Baseline to 12 months (evaluations at 6 and 12 months)|Secondary end point of efficacy showed response of renal cell carcinomas, which responded better to sunitinib therapy than other VHL related lesions using RECIST measure.||VHL lesion|Participants||Number
723434|NCT00330616|Secondary|Serious Adverse Events||Baseline through Week 8|Safety population - all subjects who took at least one dose of study medication.||Participants|||Number
723435|NCT00330616|Secondary|Adverse Events (>=5% Incidence)||Baseline through Week 8|Safety population - all subjects who took at least one dose of study medication.||Participants|||Number
723436|NCT00330616|Secondary|Change From Baseline in Clinical Global Impression (CGI) Severity of Illness Score at Weeks 1, 2, 3, 4, 8|The CGI-S assesses the investigator's impression of the severity of the patient's current illness. The time span is the week before the rating and the score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Baseline, Weeks 1, 2, 3, 4, 8|Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.||Scores on a scale||Standard Deviation|Mean
723437|NCT00330616|Secondary|Percentage of Responders Based on the Clinical Global Impression - Global Improvement Score (CGI-I)at Week 4 and Week 8|The CGI-I assesses the investigator's impression of the patient's current illness. The time span is the week before the rating and the score ranges from 1 (very much improved) to 7 (very much worse). Responders are subjects that have a score of 1 (very much improved) or 2 (much improved) on the CGI-I.|Week 4 and Week 8|Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.||Percentage of Responders|||Number
723438|NCT00330616|Secondary|Hamilton Rating Scale for Depression (HAM-D) Total Score at Week 4 and Week 8|The Hamilton Rating Scale for Depression (HAM-D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill).|Week 4 and Week 8|Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.||Scores on a scale||Standard Deviation|Mean
723439|NCT00330616|Secondary|Percentage of Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) for Each Question's Score at Week 8|The Hamilton Rating Scale for Depression (HAM-D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill).|Baseline and Week 8|Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.||Percentage of Change||Standard Deviation|Mean
723440|NCT00330616|Secondary|Percentage of Change From Baseline in Hamilton Rating Scale for Depression (HAM-D)for Each Question's Score at Week 4|The Hamilton Rating Scale for Depression (HAM-D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM-D score range from 0 (not ill) to 53 (severely ill).|Baseline and Week 4|Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.||Percentage of Change||Standard Deviation|Mean
723441|NCT00330616|Secondary|Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) for Each Question's Score at Week 8|The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill).|Baseline and Week 8|Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.||Scores on a scale||Standard Deviation|Mean
723442|NCT00330616|Secondary|Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) of Each Question's Score at Week 4|The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill).|Baseline and Week 4|Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.||Scores on a scale||Standard Deviation|Mean
723582|NCT00324649|Secondary|Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL)|Change = Week 48 value minus baseline value.|Baseline to Week 48|Treated participants. Missing values were excluded.||mg/dL||Inter-Quartile Range|Median
723443|NCT00330616|Secondary|Percentage of Remitters Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 8|The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill). Remitters are defined as subjects with a HAM D total score of </= 7.|Week 8|Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.||Percentage of Remitters|||Number
723444|NCT00330616|Secondary|Percentage of Remitters Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 4|The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill). Remitters are defined as subjects with a HAM D total score of </= 7.|Week 4|Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.||Percentage of Remitters|||Number
723445|NCT00330616|Secondary|Percentage of Responders Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 8|The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill). Responders are defined as subjects that had a decrease of >/= 50% total score on the HAM D.|Week 8|Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.||Percentage of Responders|||Number
723446|NCT00330616|Secondary|Percentage of Responders Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 4|The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill). Responders are defined as subjects that had a decrease of >/= 50% total score on the HAM D.|Week 4|Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.||Percentage of Responders|||Number
723447|NCT00330616|Secondary|Percentage Change From Baseline in Hamilton Rating Scale for Depression (HAM-D)Total Score at Week 8|The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill).|Baseline and Week 8|Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.||Percentage of Change||Standard Deviation|Mean
723448|NCT00330616|Secondary|Percentage Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) Total Score at Week 4|The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill).|Baseline and Week 4|Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.||Percentage of Change||Standard Deviation|Mean
723449|NCT00330616|Primary|Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) Total Score at Week 8|The Hamilton Rating Scale for Depression (HAM D) contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill).|Baseline and Week 8|Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.||Scores on a scale||Standard Deviation|Mean
723450|NCT00330668|Secondary|Height SD Score||during the course of the study|||SD score||Standard Deviation|Mean
723451|NCT00330668|Secondary|Height Velocity Standard Deviation (SD) Score||during the course of the study|||SD score||Standard Deviation|Mean
723452|NCT00330668|Secondary|Height Velocities During Subsequent Years of rh IGF-1 Treatment|Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement.|after 2, 3 and 5 years of treatment|||cm/year||Standard Deviation|Mean
723453|NCT00330668|Primary|Height Velocity in Modified Intent-to-Treat Population (ITT Patients Randomized to 120 Mcg/kg Twice Daily)|Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement.|after one year of treatment|||cm/year||Standard Deviation|Mean
723454|NCT00330681|Secondary|Percentage of Participants With Abnormal Changes in Sensory Examinations||24 weeks|||percentage of participants|||Number
723455|NCT00330681|Secondary|Percentage of Participants With Laboratory Tests for Which the Incidence of Abnormal Changes Was 5% or Higher in Either Group||24 weeks|"1 patient with missing data was excluded from the FAS in the Placebo of MCI-186 group."||percentage of participants|||Number
723456|NCT00330681|Secondary|Percentage of Participants With Adverse Drug Reactions||24 weeks|||percentage of participants|||Number
723457|NCT00330681|Secondary|Percentage of Participants With Adverse Events||24 weeks|||percentage of participants|||Number
723458|NCT00330681|Secondary|Change From Baseline in ALS Assessment Questionnaire (40 Items) (ALSAQ40) in Full Analysis Set (FAS) Population at 24 Weeks|The ALSAQ40 score is a measure of QoL for patients with ALS. The ALSAQ40 evaluates domains that include physical mobility, ADL and independence, eating and drinking, communication, and emotional reactions. Worst=200, Best=40|baseline and 24 weeks|"1 patient with diseases other than ALS, 1 patient who did not reach the end of cycle 3 and 5 patients with missing data were excluded from the FAS in the MCI-186 group.
5 patients who did not reach the end of cycle 3 and 4 patients with missing data were excluded from the FAS in the Placebo of MCI-186 group."||units on a scale||Standard Error|Least Squares Mean
723459|NCT00330681|Secondary|Change From Baseline in Modified Norris Scale Score in Full Analysis Set (FAS) Population at 24 Weeks|The Modified Norris Scale is a measure of movement disorder for patients with ALS. Worst=0, Best=102|baseline and 24 weeks|"1 patient with diseases other than ALS, 1 patient who did not reach the end of cycle 3 and 5 patients with missing data were excluded from the FAS in the MCI-186 group.
5 patients who did not reach the end of cycle 3 and 2 patients with missing data were excluded from the FAS in the Placebo of MCI-186 group."||units on a scale||Standard Error|Least Squares Mean
723460|NCT00330681|Secondary|Change From Baseline in % Forced Vital Capacity (%FVC) in Full Analysis Set (FAS) Population at 24 Weeks||baseline and 24 weeks|"1 patient with diseases other than ALS and 1 patient who did not reach the end of cycle 3 were excluded from the FAS in the MCI-186 group.
5 patients who did not reach the end of cycle 3 were excluded from the FAS in the Placebo of MCI-186 group."||percentage of FVC||Standard Error|Least Squares Mean
723461|NCT00330681|Secondary|Death or a Specified State of Disease Progression|Any of “death, disability of independent ambulation, loss of upper arm function, tracheotomy, use of respirator, and use of tube feeding” was defined as an event.|24 weeks|"1 patient with diseases other than ALS was excluded from the FAS in the MCI-186 group."||participants|||Number
723462|NCT00330681|Primary|Change From Baseline in Revised ALS Functional Rating Scale (ALSFRS-R) Score in Full Analysis Set (FAS) Population at 24 Weeks|ALSFRS-R Score: 0=worst; 48=best|baseline and 24 weeks|"1 patient with diseases other than ALS and 1 patient who did not reach the end of cycle 3 were excluded from the FAS in the MCI-186 group.
5 patients who did not reach the end of cycle 3 were excluded from the FAS in the Placebo of MCI-186 group."||units on a scale||Standard Error|Least Squares Mean
723463|NCT00330733|Secondary|Endothelial Dysfunction||8 and 12 weeks||||||
723464|NCT00330733|Secondary|Parameters of Cardiovascular Disease Risk, Including Glucose, Triglycerides, HDL and Blood Pressure||8 and 12 weeks||09/2013||||
723465|NCT00330733|Secondary|Plasma Levels of a Variety of Inflammatory Proteins||8 and 12 weeks||||||
723466|NCT00330733|Secondary|Glucose Area Under the Curve in These Subjects||3 months||||||
723467|NCT00330733|Primary|Change in Systemic Glucose Disposal- Glucose Infusion Rates|Participants were admitted to the Clinical Research Units at 06:00–08:00 hours after an overnight fast. Euglycaemic–hyperinsulinaemic clamps were conducted at baseline and at the end of the study. Because salsalate therapy appears to decrease insulin clearance leading to higher circulating insulin levels during the clamp, we reduced the infusion rate of insulin in the active treatment arm by 20% (from 100 to 80 mUm−2 min−1) at the study end. Insulin solutions were prepared by the site pharmacist so that study staff remained blinded to drug assignment. Whole-body insulin sensitivity was estimated from glucose infusion rate (GIR) during last 30 min of insulin infusions.|3 months|analysis was performed on all participants with available baseline and final clamp studies||percent change from baseline||95% Confidence Interval|Median
723468|NCT00330759|Secondary|Time to the First-and-Subsequent On-Study Skeletal-Related Event|"Time to the first-and-subsequent on-study skeletal-related event (SRE) using multiple event analysis. To be considered a subsequent SRE, the event must occur at least 21 days after the previous SRE.
This outcome measure utilizes multiple event times, was analyzed based on a proportional mean model, and is therefore more appropriately summarized by the cumulative mean number of events."|up to 33 months|Full Analysis Set, composed of all randomized participants||Events|||Number
723469|NCT00330759|Secondary|Time to First On-Study Skeletal-Related Event (Superiority)|Time to first on-study skeletal-related event (SRE) using a test for superiority. Median was estimated using the Kaplan-Meier method.|up to 33 months|Full Analysis Set, composed of all randomized participants.||Days||95% Confidence Interval|Median
723470|NCT00330759|Primary|Time to the First On-Study Skeletal-Related Event (Non-Inferiority)|Time to the first on-study skeletal-related event (SRE) using a non-inferiority analysis. Median was estimated using the Kaplan-Meier method.|up to 33 months|Full Analysis Set, composed of all randomized participants.||Days||95% Confidence Interval|Median
723471|NCT00330876|Secondary|Change From Baseline in Total Cholesterol|Percent change from baseline in total cholesterol (TC)|Baseline to 60 weeks|Subjects with a measurement at Week 60||percent change||Standard Deviation|Mean
723472|NCT00330876|Primary|Change From Baseline in LDL-C|percent change from baseline in low density lipoprotein-cholesterol (LDL-C)|Baseline to 60 weeks|Subjects with measurement at Week 60||percent change||Standard Deviation|Mean
723473|NCT00330915|Secondary|Number of Participants Receiving Sphincter Saving Surgery||surgery following 3 cycles (21-day cycles) of chemotherapy|Number of participants enrolled.||participants|||Number
723474|NCT00330915|Secondary|Number of Participants With Complete Tumor Resection||surgery following 3 cycles (21-day cycles) of chemotherapy|Number of participants enrolled.||participants|||Number
723475|NCT00330915|Secondary|Pathological Complete Response (pCR)|Pathological complete response was defined as the absence of any tumor cells.|surgery following 3 cycles (21-day cycles) of chemotherapy|Number of participants enrolled.||participants|||Number
723476|NCT00330915|Primary|Feasibility of Pemetrexed Prior to Surgery|Feasibility was defined as the ability to receive the total planned dose of Pemetrexed administered over a period of no more than 9 weeks permitting scheduling conflict. A ±5 percent variance in the calculated total dose was allowed.|3 cycles (21-day cycles)|Number of participants enrolled.||participants|||Number
723477|NCT00330928|Secondary|Cardiac Events That Occur Within 1 Year Post Enrollment Will be Examined for Link to Lipid Signals.|Major adverse cardiac events (MACE: myocardial infarction, cardiac surgery, death, cerebral vascular accident, coronary revascularization) will be evaluated relation to baseline presence of lipid signals by near infrared spectroscopy. This study is not powered to reach statistical significance for this outcome.|1 year||||||
723478|NCT00330928|Secondary|Clinical Cardiac Events Definitely Attributable to the Study Device That Occur From Enrollment to 7 Days Post Enrollment|Major adverse cardiac events (MACE: myocardial infarction, cardiac surgery, death, cerebral vascular accident, coronary revascularization) will be evaluated for being categorized as Definitely attributable to the study device.|Baseline to 7 day|All patients that were enrolled, intent to treat population, were evaluated for definite or probable relation to the investigational device. This includes 7 subjects that were not exposed to the investigational device.||participants|||Number
723479|NCT00330928|Secondary|Identification of Distinct Near Infrared Spectral Characteristics Associated With Special Coronary Artery Features Identified by Angiography and/or Intravascular Ultrasound and Patient Characteristics||Baseline||||||
723480|NCT00330928|Secondary|Review of Lipid Core Plaque of Interest Near Infrared Signals Observed at Baseline in Patients With Stable Angina vs Acute Coronary Syndromes|This is an exploratory examination to determine if an association exists between the presence or characteristics of lipid core plaques of interest signals and the clinical designation of acute or stable coronary artery disease in enrolled subjects. The study is not powered for statistical significance for this outcome.|Baseline||||||
723481|NCT00330928|Primary|Spectral Similarity|Average spectral similarity of the spectra in a complete scan per patient as compared to the autopsy spectral data set.Clinical data was considered similar to autopsy data if average spectral similarity in each scan was >=67%, on a continuous range of 0%(different) to 100%(identical) similarity.|Baseline|58 Subjects were excluded from endpoint analysis for No NIRS data(17), Inadequate data per protocol(11), and Data Accessible during comparison set generation(30).A similarity success was met if >80% of the NIRS data for a subject was similar to the autopsy NIRS set.||percent similarity||95% Confidence Interval|Mean
723482|NCT00330967|Primary|JNK MAPK Expression With Femoral Lipid and Insulin Infusions|JNK MAPK expression in response to femoral lipid and insulin infusions in skeletal muscle. Relative protein expression was calculated by densitometry analysis of Western blots, normalized to a housekeeping protein, GAPDH, of control and treated groups.|4 h|||ratio||Standard Deviation|Mean
723483|NCT00330967|Primary|Phospho-JNK MAPK Expression With Femoral Lipid and Insulin Infusions|Phosphorylation of JNK MAPK in response to femoral lipid and insulin infusions in skeletal muscle. Relative protein expression was calculated by densitometry analysis of Western blots, normalized to a housekeeping protein, GAPDH, of control and treated groups.|4 h|||ratio||Standard Deviation|Mean
723484|NCT00330967|Primary|ERK MAPK Expression With Femoral Lipid and Insulin Infusions|ERK MAPK expression in response to femoral lipid and insulin infusions in skeletal muscle. Relative protein expression was calculated by densitometry analysis of Western blots, normalized to a housekeeping protein, GAPDH, of control and treated groups.|4 h|||ratio||Standard Deviation|Mean
723485|NCT00330967|Primary|Phospho-ERK MAPK Expression With Femoral Lipid and Insulin Infusions|Phosphorylation of ERK MAPK in response to femoral lipid and insulin infusions in skeletal muscle. Relative protein expression was calculated by densitometry analysis of Western blots, normalized to a housekeeping protein, GAPDH, of control and treated groups.|4 h|||ratio||Standard Deviation|Mean
723486|NCT00330967|Primary|p38 MAPK Expression With Femoral Lipid and Insulin Infusions|p38 MAPK expression in response to femoral lipid and insulin infusions in skeletal muscle. Relative protein expression was calculated by densitometry analysis of Western blots, normalized to a housekeeping protein, GAPDH, of control and treated groups.|4 h|||ratio||Standard Deviation|Mean
723487|NCT00330967|Primary|Phos-p38 MAPK Expression With Femoral Lipid and Insulin Infusions|Phosphorylation of p38 MAPK in response to femoral lipid and insulin infusions. phospho-p38 MAPK expression in response to femoral lipid infusion in skeletal muscle. Relative protein expression was calculated by densitometry analysis of Western blots, normalized to a housekeeping protein, GAPDH, of control and treated groups.|4 h|||ratio||Standard Deviation|Mean
723488|NCT00330967|Primary|Insulin Signaling With Lipid Infusion|IRS-1 expression in response to femoral lipid infusion in skeletal muscle. Relative protein expression was calculated by densitometry analysis of Western blot bands, normalized to a housekeeping protein, GAPDH, in control and treated groups.|4 h|||ratio||Standard Deviation|Mean
723489|NCT00331006|Secondary|Proportion of Rituximab Infusions in Which a Reaction to the Infusion Was Reported|Proportion of rituximab infusions in which a reaction to the infusion was reported|Measured at Week 1 through Week 4|All rituximab infusions given to study participants||proportion of rituximab infusions|Participants|95% Confidence Interval|Number
723490|NCT00331006|Secondary|Median Number of Adverse Events Per Subject That Were Not Bleeding Events and Did Not Meet the Criteria of a Serious Adverse Event|Median Number of Adverse Events Per Subject That Were Not Bleeding Events and Did Not Meet the Criteria of a Serious Adverse Event|Measured through Week 100|Data on bleeding events were collected at every study visit for all study participants. Data for this outcome was collected through the particpants end of study or Week 100, whichever came first, and is restricted to the 16 subjects who received at least one dose of rituximab.||participants||Inter-Quartile Range|Median
723491|NCT00331006|Secondary|Median Number of Serious Adverse Events Per Subject Other Than Bleeding Events|Median Number of Serious Adverse Events Per Subject Other Than Bleeding Events|Measured through Week 100|Data on bleeding events were collected at every study visit for all study participants. Data for this outcome was collected through the particpants end of study or Week 100, whichever came first, and is restricted to the 16 subjects who received at least one dose of rituximab.||participants||Inter-Quartile Range|Median
723492|NCT00331006|Secondary|Median Number of Bleeding Events Per Subject Not Meeting the Criteria of a Serious Adverse Event|Median Number of Bleeding Events Per Subject Not Meeting the Criteria of a Serious Adverse Event|Measured through Week 100|Data on bleeding events were collected at every study visit for all study participants. Data for this outcome was collected through the particpants end of study or Week 100, whichever came first, and is restricted to the 16 subjects who received at least one dose of rituximab.||participants||Inter-Quartile Range|Median
723493|NCT00331006|Secondary|Median Number of Bleeding Events Per Subject Meeting the Criteria of a Serious Adverse Event|Median number of bleeding events per subject meeting the criteria of a serious adverse event|Measured through Week 100|Data on bleeding events were collected at every study visit for all study participants. Data for this outcome was collected through the particpants end of study or Week 100, whichever came first, and is restricted to the 16 subjects who received at least one dose of rituximab.||participants||Inter-Quartile Range|Median
723494|NCT00331006|Secondary|Percent Change in Inhibitor Titer on Challenge With Factor VIII From Baseline Challenge to Post-treatment Challenge|percent change=100%*(A-B)/B where A=inhibitor titer measured within 5-7 days following FVIII rechallenge and B=inhibitor titer measured within 5-14 days following baseline FVIII challenge. A FVIII rechallenge was performed within 10-18 days of the first monthly study visit in which an inhibitor titer result <5 BU/mL was obtained beginning 2 weeks and continuing through 18 weeks following the last rituximab infusion.|Measured within approximately 22 weeks|All subjects who received a post-treatment rechallenge and had at least a minor response.||percentage change||Inter-Quartile Range|Median
723583|NCT00324649|Secondary|Change From Baseline in Fasting Total Cholesterol|Change = Week 48 value minus baseline value.|Baseline to Week 48|Treated participants. Missing values were excluded.||mg/dL||Inter-Quartile Range|Median
723495|NCT00331006|Secondary|Proportion of Subjects With at Least Minor Response, i.e. Inhibitor Level Falls to <5 BU/mL Between Weeks 6-22 and Either Remains <5 BU/mL 5-7 Days Following FVIII Rechallenge or Titer Following FVIII Rechallenge is 5-10 BU/mL & <50% of Original Peak|Presence or absence of at least a minor response in each participant|Measured within approximately 22 weeks|All participants who received at least one dose of rituximab||proportion of participants||95% Confidence Interval|Number
723496|NCT00331006|Primary|Proportion of Subjects With Major Response, i.e. Inhibitor Level Falls to Less Than 5 BU/mL Between Weeks 6 to 22 and Remains Below 5 BU/mL at 5-7 Days Following Re-challenge With FVIII|Presence or absence of a major response in each participant. Major response is defined as occurring when inhibitor level falls to less than 5 BU/mL between Weeks 6 to 22 and remains below 5 BU/mL at 5-7 days following re-challenge with FVIII|Measured within approximately 22 weeks|All participants who received at least one dose of rituximab||proportion of participants||95% Confidence Interval|Number
723497|NCT00308061|Secondary|Geometric Mean Titers for Anti-FMP1 Antibody|Immune response was measured by anti-FMP1 endpoint titers. Data were obtained on day 0, 14, 30, 44, 60, 74, 90, 180, 272, and 364. Samples collected on vaccination days (days 0, 30, and 60) were collected immediately prior to vaccination.|Days 0, 14, 30, 44, 60, 74, 90, 180, 272, and 364|Immune response was measured by anti-FMP1 endpoint titers. Data were obtained on day 0, 14, 30, 44, 60, 74, 90, 180, 272, and 364. Samples collected on vaccination days (days 0, 30, and 60) were collected immediately prior to vaccination.||geometric mean titers||95% Confidence Interval|Geometric Mean
723498|NCT00308061|Primary|Number of Participants With Solicited Adverse Events by Immunization and Type|Number of participants with solicited adverse events by immunization and type (local, general and any) during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7.|Days 0, 1, 2, 3, 7, 30, 31, 32, 33, 37, 60, 61, 62, 63, 67|||Participants|||Count of Participants
723499|NCT00308074|Secondary|Brief Psychiatric Rating Scale for Children (BPRS-C)|"The Brief Psychiatric Rating Scale for Children is a 21-item rating scale to evaluate psychiatric problems based on the clinician’ s interview with the child/adolescent and parents. It has 7 scales: behavioral problems, depression, thought disorders, psychomotor excitation, withdrawal-retardation, anxiety, organicity. Ratings are based on a 7 point scale, from Not Present (scores 0) to Extremely Severe (scores 6 points). Total is the sum of the 21 items. The range of possible totals is 0 (no symptoms) to 126 (extremely severe).A decrease in score indicates improvement."|Baseline, Endpoint using last observation carried forward (LOCF) at weeks 3,5,7,9,11 and 13.|||units on a scale||Standard Deviation|Mean
723500|NCT00308074|Secondary|Yale-Brown Obsessive Compulsive Scale (Y-BOCS)|10-item assessment of obsessive-compulsive symptoms in patients less than 18 years of age. There are 5 items pertaining to compulsions rate symptoms (time spent, interference with functioning, distress, resistance, control) on a 5-point scale ( from 0=no symptoms/minimum severity, to 4=extreme symptoms/maximum severity). Total is the sum of 10 items. The range of possible totals is 0 (no symptoms) to 40 (severe). A decrease in value indicates improvement.|Baseline, Endpoint using last observation carried forward (LOCF) at weeks 3,5,7,9,11 and 13.|||units on a scale||Standard Deviation|Mean
723501|NCT00308074|Primary|Aberrant Behavior Checklist-Irritability Subscale|"Aberrant Behavior Checklist (ABC) The ABC is a 58 item symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. Items are rated on a 4-point scale (0=no problem to 3=severe problem). A decrease in score indicates improvement.
There are five subscales: a) Irritability and Agitation b) Lethargy and Social Withdrawal c) Stereotypic Behavior d) Hyperactivity and Noncompliance and e) Inappropriate Speech.This study uses the Irritability subscale for its outcome. The Irritability subscale is the sum of 15 items. Each item is rated using the scale: 0 = Not at all; 1 = Slight in degree; 2 = Moderately serious; and 3 = Severe in degree. The Irritability subscale total score ranges from 0 to 45. A decrease in score over time indicates improvement."|Baseline, Endpoint using last observation carried forward (LOCF) at weeks 3,5,7,9,11 and 13.|||units on a scale||Standard Deviation|Mean
723502|NCT00308074|Primary|Clinical Global Impressions-Improvement|The Clinical Global Impression – Improvement scale (CGI-I) is a 7 point scale that requires the clinician to evaluate how much the patient's illness has improved or worsened compared to their baseline condition at the beginning of the intervention. The ratings are evaluated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.|Baseline, Endpoint using last observation carried forward (LOCF) at weeks 3,5,7,9,11 and 13.|||units on a scale||Standard Deviation|Mean
723503|NCT00308087|Secondary|Summary of Cost Effectiveness|A cost-effectiveness analysis from the payer perspective was to be performed. Only direct medical costs for each patient during the study period were to be included for analysis. Costs were to be calculated by multiplying each health care resource unit by the amount reimbursed by a payer. Health care resource utilization units are a way to normalize the quantity of health care provided to each participant so that costs can be compared.|24 months|No participants were analyzed because the study was terminated early due to low enrollment.|||||
723504|NCT00308087|Secondary|Kaplan-Meier Estimates for Duration of Partial Response or Better to Treatment|Count of days in which a participant experiences a Partial Response (>=50% decrease sum of the product of the greatest diameters in the six largest dominant nodes or nodal masses) or better. Time to event was measured from the date of response to the date of progressive disease (PD) or death.|24 months|Intent to treat population.||Days||Inter-Quartile Range|Median
723505|NCT00308087|Secondary|Kaplan-Meier Estimates of Progression-Free Survival|Time to event was measured from the date of randomization to the date of first progressive disease (PD) or death.|24 months|Intent to treat population||Days||Inter-Quartile Range|Median
723506|NCT00308087|Secondary|Participant Summary of Best Response Across All Visits|"Count of participants' best response within categories defined by the International Working Group (IWG):
> Complete Response (complete disappearance of detectable clinical and radiological evidence of disease),
> Complete Response Unconfirmed (unconfirmed complete disappearance),
> Partial Response (>=50% decrease sum of the product of the greatest diameters in the six largest dominant nodes or nodal masses),
> Stable Disease (neither response nor disease progression),
> Progression (new lesion or increase by 50% of previously involved sites from nadir)."|up to 24 months|Intent to treat population||participants|||Number
723584|NCT00324649|Secondary|Change From Baseline in Fasting Serum Triglycerides|Change = Week 48 value minus baseline value.|Baseline to Week 48|Treated participants. Missing values were excluded.||mg/dL||Inter-Quartile Range|Median
723507|NCT00308087|Secondary|Summary of Treatment-Emergent Adverse Events (TEAE)|Count of the number of participants who experienced treatment emergent adverse events (TEAEs). TEAEs occurred during the time study intervention was being taken occurring on or after Day 1 and no longer than 30 days after the last dose of study medication.|up to 12 weeks|Safety population||participants|||Number
723508|NCT00308087|Primary|Number of Participants With a Complete Response or Unconfirmed Complete Response at Week 8 With Confirmation at Week 12|Count of number of participants who responded with a Complete Response (complete disappearance of all detectable clinical and radiological evidence of disease) at week 8 and again clinically and radiologically confirmed at week 12.|Week 8 (confirmed at Week 12)|Intent to treat population||participants|||Number
723509|NCT00308113|Secondary|Compare Side Effect Profiles of the Three Study Groups|To compare side effect profiles of the three regimens to the enhanced standard of care group, to include height, weight, weight/height ratio, body mass index, cataract formation, blood glucose, blood pressure, and behavioral changes.|12 months|No analysis was performed as the study was closed with N=3 out of 120 and side effects profile between groups could not be analyzed.|||||
723510|NCT00308113|Primary|One Year Change in Pulmonary Function (Forced Expiratory Volume, FEV1 and Forced Vital Capacity, FVC)|Comparing change from baseline levels in pulmonary function (FEV1 and FVC) in the three treatment groups relative to the enhanced standard of care group and relative to each other at one year.|12 months|No analysis was performed as only 1 out of 3 participants completed all the pulmonary function measurements before the protocol was closed.|||||
723511|NCT00308113|Primary|One Year Change of Left Ventricular Mean Systolic Wall Stress/Rate-corrected Velocity of Fiber Shortening Relation.|Comparing change from baseline of mean systolic wall stress and rate-corrected mean velocity of circumferential shortening in the three treatment groups relative to the enhanced standard of care group and relative to each other at one year. The values are obtained via an echocardiogram read locally at each site.|12 months|No analysis was performed as only 1 out of 3 participants completed all echocardiogram measurements before the protocol was closed.|||||
723512|NCT00308139|Secondary|Assessment on Event Rate of Treatment-emergent Hypoglycemic Events With Non-SU Use at Screening|The major hypoglycemia category included events that, in the judgment of the investigator or physician, resulted in loss of consciousness, seizure, coma, or other change in mental status consistent with neuroglycopenia, in which symptoms resolved after administration of intramuscular glucagon or intravenous glucose, required third-party assistance, and was accompanied by a blood glucose concentration of less than 54 mg/dL prior to treatment, whether or not symptoms of hypoglycemia were perceived by the subject. The minor hypoglycemia were accompanied by a blood glucose concentration of less than 54 mg/dL prior to treatment and not classified as major hypoglycemia.|Day 1 to Week 364|ITT Population who participated in the 30-week assessment period and not using SU at screening.||events per subject-year||Standard Error|Mean
723513|NCT00308139|Secondary|Assessment on Event Rate of Treatment-emergent Hypoglycemic Events With SU Use at Screening|The major hypoglycemia category included events that, in the judgment of the investigator or physician, resulted in loss of consciousness, seizure, coma, or other change in mental status consistent with neuroglycopenia, in which symptoms resolved after administration of intramuscular glucagon or intravenous glucose, required third-party assistance, and was accompanied by a blood glucose concentration of less than 54 mg/dL prior to treatment, whether or not symptoms of hypoglycemia were perceived by the subject. The minor hypoglycemia were accompanied by a blood glucose concentration of less than 54 mg/dL prior to treatment and not classified as major hypoglycemia.|Day 1 to Week 364|ITT Population who participated in the 30-week assessment period and using SU at screening.||events per subject-year||Standard Error|Mean
723514|NCT00308139|Secondary|Ratio of Triglycerides at Week 364 to Baseline|Ratio of triglycerides (measured in mg/dL) at Week 364 to baseline (Day -3). Log (Postbaseline Triglycerides) - log (Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline.|Day -3, Week 364|7-Year Completer Population. Missing data up to Week 364 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.||ratio||95% Confidence Interval|Least Squares Mean
723515|NCT00308139|Secondary|Ratio of Triglycerides at Week 30 to Baseline|Ratio of triglycerides (measured in mg/dL) at Week 30 to baseline (Day -3). Log (Postbaseline Triglycerides) - log (Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline.|Day -3, Week 30|ITT Population. Missing data up to Week 30 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.||ratio||Standard Error|Least Squares Mean
723516|NCT00308139|Secondary|Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 364|Change in low-density lipoprotein cholesterol (LDL-C) from baseline (Day -3) to Week 364.|Day -3, Week 364|7-Year Completer Population. Missing data up to Week 364 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.||mg/dL||95% Confidence Interval|Least Squares Mean
723517|NCT00308139|Secondary|Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 364|Change in high-density lipoprotein cholesterol (HDL-C) from baseline (Day -3) to Week 364.|Day -3, Week 364|7-Year Completer Population. Missing data up to Week 364 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.||mg/dL||95% Confidence Interval|Least Squares Mean
723518|NCT00308139|Secondary|Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 30|Change in high-density lipoprotein cholesterol (HDL-C) from baseline (Day -3) to Week 30.|Day -3, Week 30|ITT Population. Missing data up to Week 30 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.||mg/dL||Standard Error|Least Squares Mean
723519|NCT00308139|Secondary|Change in Total Cholesterol From Baseline to Week 364|Change in total cholesterol from baseline (Day -3) to Week 364.|Day -3, Week 364|7-Year Completer Population. Missing data up to Week 364 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.||mg/dL||95% Confidence Interval|Least Squares Mean
723585|NCT00324649|Secondary|Change From Baseline in Cluster Determinant 4 (CD4) Cell Count|Change = Week 48 value minus baseline value.|Baseline to Week 48|Treated participants. Missing values were excluded.||cells/mm^3||Inter-Quartile Range|Median
723520|NCT00308139|Secondary|Change in Total Cholesterol From Baseline to Week 30|Change in total cholesterol from baseline (Day -3) to Week 30.|Day -3, Week 30|ITT Population. Missing data up to Week 30 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.||mg/dL||Standard Error|Least Squares Mean
723521|NCT00308139|Secondary|Change in Blood Pressure From Baseline to Week 364|Change in Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure from baseline to Week 364|Day -3, Week 364|7-Year Completer Population using observed data.||mmHg||Standard Deviation|Mean
723522|NCT00308139|Secondary|Change in Blood Pressure From Baseline to Week 30|Change in Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure from baseline to Week 30|Day -3, Week 30|ITT Population using observed data.||mmHg||Standard Error|Mean
723523|NCT00308139|Secondary|Change in Fasting Plasma Glucose From Baseline to Week 364|Change in fasting plasma glucose from baseline (Day -3) to Week 364.|Day -3, Week 364|7-Year Completer Population. Missing data up to Week 364 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.||mg/dL||95% Confidence Interval|Least Squares Mean
723524|NCT00308139|Secondary|Change in Fasting Plasma Glucose From Baseline to Week 30|Change in fasting plasma glucose from baseline (Day -3) to Week 30.|Day -3, Week 30|ITT Population. Missing data up to Week 30 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.||mg/dL||Standard Error|Least Squares Mean
723525|NCT00308139|Secondary|Change in Body Weight From Baseline to Week 364|Change in body weight from baseline (Day -3) to Week 364|Day -3, Week 364|7-Year Completer Population. Missing data up to Week 364 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.||kg||95% Confidence Interval|Least Squares Mean
723526|NCT00308139|Secondary|Change in Body Weight From Baseline to Week 30|Change in body weight from baseline (Day -3) to Week 30|Day -3, Week 30|ITT Population. Missing data up to Week 30 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.||kg||Standard Error|Least Squares Mean
723527|NCT00308139|Secondary|Sub-study Safety and Tolerability of Exenatide When Administered Using the Once Weekly Single Dose Tray and the Once Weekly Dual (Single Dose Tray-11 Weekly Doses Switch to Dual Chamber Pen-11 Weekly Dose)|Measure by geometric mean ratio of the maximum steady state plasma exenatide concentration Css, max at Visit 11-14 to Visit 24-27 with 90% confidence interval and incidence of treatment-emergent injection site adverse events.|Week 22||||||
723528|NCT00308139|Secondary|Change in 2 Hours (2h) Postprandial Glucose From Baseline to Week 14|Change in 2h Postprandial Glucose from baseline (Day -3) to Week 14|Day -3, Week 14|Evaluable Meal Tolerance Cohort consisted of ITT subjects who participated in the meal tolerance test and had adequate data to allow the reliable assessment of pharmacodynamics. Only subjects with non-missing baseline and Week 14 values were included in analysis.||mg/dL||Standard Error|Least Squares Mean
723529|NCT00308139|Secondary|Exenatide LAR Steady State Concentration From Week 29 to Week 30|Steady-state plasma exenatide concentration over the dosing interval of Week 29 to Week 30 (0-168 hours) was evaluated. Geometric mean for the average steady-state concentration and its 10th and 90th percentiles were reported.|Week 29 to Week 30|The Pharmacokinetics Population consisted of subjects who received exenatide LAR treatment, and had adequate plasma exenatide concentration-time data to allow for reliable evaluation of exenatide LAR pharmacokinetics.||pg/mL||Inter-Quartile Range|Geometric Mean
723530|NCT00308139|Secondary|Percentage of Subjects Achieving HbA1c Target of <=6.0%|Percentage of subjects achieving HbA1c target values of <=6.0% at Week 30.|Week 30|ITT Population. Missing data up to Week 30 were imputed using LOCF for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. Subjects without post-baseline measurement were categorized as not achieving goal.||percentage of subjects|||Number
723531|NCT00308139|Secondary|Percentage of Subjects Achieving HbA1c Target of <=6.5%|Percentages of subjects achieving HbA1c target values of <=6.5% at Week 364|Week 364|7-Year Completer Population. Missing data up to Week 364 were imputed using LOCF for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. Subjects without post-baseline measurement were categorized as not achieving goal.||percentage of subjects|||Number
723532|NCT00308139|Secondary|Percentage of Subjects Achieving HbA1c Target of <=6.5%|Percentages of subjects achieving HbA1c target values of <=6.5% at Week 30.|Week 30|ITT Population. Missing data up to Week 30 were imputed using LOCF for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. Subjects without post-baseline measurement were categorized as not achieving goal.||percentage of subjects|||Number
723533|NCT00308139|Secondary|Percentage of Subjects Achieving HbA1c Target of <7%|Percentages of subjects achieving HbA1c target value of <7% at Week 364|Week 364|7-Year Completer Population. Missing data up to Week 364 were imputed using LOCF for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. Subjects without post-baseline measurement were categorized as not achieving goal.||percentage of subjects|||Number
723534|NCT00308139|Secondary|Percentage of Subjects Achieving HbA1c Target of <7%|Percentage of subjects achieving HbA1c target value of <7% at Week 30.|Week 30|ITT Population. Missing data up to Week 30 were imputed using LOCF for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. Subjects without post-baseline measurement were categorized as not achieving goal.||percentage of subjects|||Number
723535|NCT00308139|Primary|Sub-study Relative Bioavailability of Exenatide When Administered Using the Exenatide Once Weekly Dual Chambered Pen and the Exenatide Once Weekly Single Dose Tray (Single Dose Tray-11 Weekly Doses Switch to Dual Chamber Pen-11 Weekly Dose)|Measure by Geometric mean ratio (GMR) of plasma exenatide average steady state concentration Css,avg at Visit 11-14 to Visit 24-27 with 90% confidence interval|Week 22||||||
723536|NCT00308139|Secondary|Change in HbA1c From Baseline to Week 364|Absolute change in HbA1c from Baseline (Day -3) to Week 364|Day -3, Week 364|7-Year Completer Population. Missing data up to Week 364 were imputed using the last observation carried forward (LOCF) approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.||percentage of total hemoglobin||95% Confidence Interval|Least Squares Mean
723537|NCT00308139|Primary|Change in HbA1c From Baseline to Week 30|Absolute change in HbA1c from Baseline (Day -3) to Week 30 [Week 30 - Baseline]|Day -3, Week 30|The ITT Population consisted of all randomized subjects who received at least one injection of study medication. Missing data up to Week 30 were imputed using the last observation carried forward (LOCF) approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.||percentage of total hemoglobin||Standard Error|Least Squares Mean
723538|NCT00308230|Primary|BNP Levels|Levels of B-type naturietic peptide in the blood|1 day|||pg/ml||Standard Deviation|Mean
723539|NCT00308308|Secondary|Severe Hypoglycemia Event Rate|Number of Severe Hypoglycemic Events/Total Subject Exposure Time (in months)|Baseline to Week 52|Safety Population||Number of events/subject-month|||Number
723540|NCT00308308|Secondary|Total Hypoglycemia Event Rate|Number of Hypoglycemic Events/Total Subject Exposure Time (in months)|Baseline to Week 52|Safety Population||Number of events/subject-month|||Number
723541|NCT00308308|Secondary|Incidence of Severe Hypoglycemia|"Severe hypoglycemia occurs when all 3 of the following occur simultaneously:
Subject requires the assistance of another person;
Subject exhibits at least 1 cognitive neurological symptom (memory loss, confusion, uncontrollable behavior, irrational behavior, unusual difficulty in awakening, seizure, loss of consciousness);
Measured BG is ≤ 49 mg/dL (2.7 mmol/L), or, in the absence of a BG measurement, clinical symptoms are reversed by oral carbohydrates, sc glucagon or intravenous glucose administration; OR,
Measured BG is ≤ 36 mg/dL (2.0 mmol/L) with or without symptoms."|Baseline to Week 52|Safety Population||percentage of participants|||Number
723542|NCT00308308|Secondary|Incidence of Total Hypoglycemia|Defined as hypoglycemic symptoms that are relieved with carbohydrate intake or blood glucose measurement <= 63 mg/dL, regardless of symptoms.|Baseline to Week 52|Safety population||percentage of participants|||Number
723543|NCT00308308|Secondary|Number of Subjects Achieving Week 52 HbA1c Levels Less Than or Equal to 7.0%|Number of subjects achieving week 52 HbA1c levels less than or equal to 7.0%|Baseline to Week 52|participants in ITT population with available data||Participants|||Number
723544|NCT00308308|Secondary|Change From Baseline in Fasting Plasma Glucose to Week 52|Change from baseline in fasting plasma glucose at Week 52|Baseline to Week 52|participants in ITT population with available data||mg/dl||Standard Error|Least Squares Mean
723545|NCT00308308|Secondary|Change From Baseline in Weight to Week 52|Change from baseline in weight at Week 52|Baseline to Week 52|participants in ITT population with available data||kilogram||Standard Error|Least Squares Mean
723546|NCT00308308|Primary|Compare the Mean Change From Baseline to Week 52 in HbA1c||Baseline to Week 52|Intention to treat (ITT) with Last Observation Carried Forward (LOCF)||Percentage||Standard Error|Least Squares Mean
723547|NCT00313781|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUC0-tau) for CP-751,871||Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose)|The summary table of this outcome measure was not provided based on lack of resources as the program was terminated.|||||
723548|NCT00313781|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) for CP-751,871||Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose)|The summary table of this outcome measure was not provided based on lack of resources as the program was terminated.|||||
723549|NCT00313781|Secondary|Maximum Observed Plasma Concentration (Cmax) for CP-751,871||Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose)|The summary table of this outcome measure was not provided based on lack of resources as the program was terminated.|||||
723550|NCT00313781|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) for CP-751,871|Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration.|Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose)|The summary table of this outcome measure was not provided based on lack of resources as the program was terminated.|||||
723551|NCT00313781|Secondary|Pain Measured by the Modified Brief Pain Inventory‑Short Form (mBPI‑sf Modified Pfizer)|"The mBPI-sf was a self administered questionnaire developed to assess pain severity and pain interference with functional activities during a 24-hour period prior to evaluation. For the worst pain item of the mBPI-sf scale (11 point Likert scale; range: 0 [no pain] to 10 [pain as bad as you can imagine]), participants were asked to rate their pain by marking an X in one of the 10 boxes that best described their pain at its worst in the last 24 hours post surgery and at least 12 hours after discontinuation of the peripheral nerve block or neuraxial block."|Baseline, Cycle 1 to Cycle 10 before drug administration and end of treatment (up to 28 days post last dose)|The summary table was not provided based on 1) the negative primary finding of the study that CP-751,871 did not improve response in CP-751,871+Docetaxel + Prednisone and had significantly worse PFS than Docetaxel +Prednisone, which rendered the PRO summary irrelevant 2) lack of resources as the program was terminated.|||||
723552|NCT00313781|Secondary|Quality of Life Measured by the Functional Assessment of Cancer Treatment‑Prostate (FACT‑P)|The FACT-P was a 39-item participant questionnaire which assesses physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and additional prostate cancer specific concerns (12 items). All items were scored from 0 (not at all) to 4 (very much). The total FACT-P score ranged from 0-156, with higher scores representing a better QoL with fewer symptoms. A score of 156 represented the best outcome.|Baseline, Cycle 1 to Cycle 10 before drug administration and end of treatment (up to 28 days post last dose)|The summary table was not provided based on 1) the negative primary finding of the study that CP-751,871 did not improve response in CP-751,871+Docetaxel + Prednisone and had significantly worse PFS than Docetaxel +Prednisone, which rendered the patient reported outcome (PRO) summary irrelevant 2) lack of resources as the program was terminated.|||||
723553|NCT00313781|Secondary|Total Number of the Insulin Like Growth Factor Receptor Type 1 (IGF-1R) Positive CTCs|Blood samples were collected to enumerate the number of total IGF-1R positive CTCs via Veridex CellSearch technology in which CTCs were identified based on cell surface positive EpCAM and cytokeratin staining. A separate CellSave tube of cells was also collected and processed with cell surface staining of IGF-1R to enumerate surfaces of IGF-1R-positive CTCs.|Baseline, prior to dosing in odd numbered cycles (ie. Cycle 1, 3, 5, etc) and end of treatment (up to 28 days post last dose)|Participants who were enrolled to the study were included in the analysis. n = number of participants with evaluable data at each timeframe.||Number of IGF-1R positive CTCs/7.5 mL||Standard Deviation|Mean
723554|NCT00313781|Secondary|Total Number of Circulation Tumor Cells (CTCs)|Blood samples were collected and processed to enumerate the number of total CTCs via Veridex CellSearch technology in which CTCs were identified based on cell surface positive epithelial cell adhesion molecule (EpCAM) and cytokeratin staining.|Baseline, prior to dosing in odd numbered cycles (ie. Cycle 1, 3, 5, etc) and end of treatment (up to 28 days post last dose)|Participants who were enrolled to the study were included in the analysis. n = number of participants with evaluable data at each timeframe.||Number of CTCs/7.5 mL||Standard Deviation|Mean
723555|NCT00313781|Secondary|Population PK Parameters of CP-751,871|Population pharmacokinetic analysis involved mixed effects modeling using nonlinear mixed effects modeling (NONMEM) software. The intent of this analysis was to establish a basic population pharmacokinetic model for CP-751,871 and to determine inter-individual and residual variability in population clearance, and volume of distribution of drug. Relationship of demographic variables (gender, age, body weight, height and ethnicity), concomitant medications and measures of altered hepatic and renal function were examined by fitting measured CP-751,871 concentrations|Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose)||||||
723556|NCT00313781|Secondary|Human Anti-human Antibody (HAHA) at the Last Follow-up Visit|Levels of HAHA in serum were detected at the last follow-up visit.|The last follow-up visit (150 days post last dose)|All participants who were enrolled in the study, received at least one assigned treatment and had HAHA available assessment.||mg/dl||Standard Deviation|Mean
723557|NCT00313781|Secondary|Human Anti-human Antibody (HAHA) at Baseline (Day 1 of Cycle 1)|Levels of HAHA in serum were detected at baseline.|Baseline (Day 1 of Cycle 1)|All participants who were enrolled in the study, received at least one assigned treatment and had available HAHA assessment.||mg/deciliter (dl)||Standard Deviation|Mean
723558|NCT00313781|Secondary|Progression Free Survival (PFS)|PFS was defined as the time from randomization to first event of disease progression. Disease progression events were defined as the following: PSA progression,objective disease progression as per RECIST, death, and discontinuation of treatment due to symptomatic deterioration. PSA progression was defined as the time-point of PSA progression on 2 successive evaluations taken 1 week apart after dosing in cycle 3.|Baseline, Day 15 of each cycle and follow-up (monthly, up to 150 days post last dose)|Full analysis set included all participants who were enrolled into the study and received at least one assigned treatment.||Months||95% Confidence Interval|Median
723559|NCT00313781|Primary|Percentage of Participants With Prostate Specific Antigen (PSA) Best Response|Percentage of participants with PSA best response of either PSA normalization (PN) or partial PSA response (PR) relative to the total number of participants evaluable for response. PN was defined as PSA =< 0.2 nanogram/milliliter (ng/ml) on 2 successive evaluations at least 3 weeks apart and no imaging or clinical evidence of disease progression. PP was defined as >= 50% decrease in PSA from baseline on 2 successive evaluations at least 3 weeks apart and no imaging or clinical evidence of disease progression.|Baseline, Day 1 and Day 15 of each cycle, end of treatment (up to 28 days post last dose) and follow-up (monthly, up to 150 days post last dose)|Response-evaluable population: All enrolled participants who had a baseline PSA reference value and received at least one dose of assigned treatment with the exception of those participants without symptomatic or objective progression (participants with PSA progression only) who withdraw consent prior to Cycle 3.||Percentage of participants||90% Confidence Interval|Mean
723560|NCT00313820|Secondary|QANeP - Pain Rating Scales|Subject rated pain scale: static mechanical allodynia (SMA) gentle constant mechanical pressure; dynamic mechanical allodynia (DMA) gentle stroking with foam brush; punctate hyperalgesia (PH) pinprick; cold allodynia (CA) touch with cool metal rod 13-17° celsius (C); cold hyperalgesia (CH) touch with cold metal rod 4° C; temporal summation to tactile stimuli (TSTS) repeated touching/tapping. 11-point numeric scale; range 0 (no pain) to 10 (worst possible pain). Reference area=mirror image of pain site (test area). Summarized as change from baseline (mean at observation minus mean at baseline).|Baseline, Week 12|ITT; (n) = number of subjects with analyzable data at observation for pregabalin and placebo, respectively; Week 12 [LOCF].||scores on scale||Standard Deviation|Mean
723561|NCT00313820|Secondary|Quantitative Assessment of Neuropathic Pain (QANeP) - Sensory Threshold|"QANeP: assessment of sensory threshold: subject responds yes when monofilament stimulus is felt on area of maximum pain: 1 (lowest/softest 0.07 gram [g]) to 6 (highest 300 g) or 7 (not perceived); rated by lowest/softest filament felt when in contact with the skin. Summarized as change from baseline (mean at observation minus mean at baseline)."|Baseline, Week 12|ITT; Week 12 [LOCF].||scores on scale||Standard Deviation|Mean
723562|NCT00313820|Secondary|Clinical Global Impression of Change (CGIC)|CGIC: clinician rated instrument that measures change in a subject's ovall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse).|Week 12|ITT||scores on scale||Standard Error|Least Squares Mean
723563|NCT00313820|Secondary|Patient Global Impression of Change (PGIC)|PGIC: subject rated instrument to measure subject's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse).|Week 12|ITT||scores on scale||Standard Error|Least Squares Mean
723564|NCT00313820|Secondary|EQ-5D - VAS|EQ-5D: subject rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.|Week 12|ITT||scores on scale||Standard Error|Least Squares Mean
723565|NCT00313820|Secondary|Euro Quality of Life (EQ-5D)- Health State Profile Utility Score|EQ-5D: subject rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, “confined to bed”). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Week 12|ITT||scores on scale||Standard Error|Least Squares Mean
723578|NCT00324649|Secondary|Change From Baseline in Waist Circumference/Hip Circumference Ratio|Change = Week 48 value minus baseline value.|Baseline to Week 48|Treated participants. Missing values were excluded. Assessment of waist and hip circumference was added to the study schedule via protocol amendment part way through the study. This resulted in small numbers of subjects having data available for this analysis.||Ratio||Inter-Quartile Range|Median
723566|NCT00313820|Secondary|Hospital Anxiety and Depression Scale (HADS) - ITT Population|HADS is subject rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.|Week 12|ITT; Week 12 [LOCF]||scores on scale||Standard Error|Least Squares Mean
723567|NCT00313820|Secondary|Number of Subjects With Yes or No Response for Medical Outcome Study (MOS) Sleep Scale - Optimal Sleep|MOS: subject rated questionnaire to assess sleep quality and quantity. Optimal sleep component is derived from Sleep Quantity average hours of sleep each night during the past 4 weeks. Number of subjects with response = YES if sleep quantity is 7 or 8 hours per night or response = NO if sleep quantity is < 7 hours per night.|Week 12|ITT||participants|||Number
723568|NCT00313820|Secondary|Medical Outcome Study (MOS) Sleep Scale|MOS: subject rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.|Week 12|ITT; (n) = number of subjects with analyzable data at observation for pregabalin and placebo, respectively.||scores on scale||Standard Error|Least Squares Mean
723569|NCT00313820|Secondary|Neuropathic Pain Symptom Inventory (NPSI)|NPSI: subject rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score (0 to 100). Higher score indicates a greater intensity of pain.|Week 12|ITT; (N) = number of subjects with analyzable data at observation for pregabalin and placebo, respectively; Week 12/Last observation carried forward (LOCF).||scores on scale||Standard Error|Least Squares Mean
723570|NCT00313820|Secondary|Short Form-McGill Pain Questionnaire (SF-MPQ Visual Analog Scale [VAS]) - Part B Only|SF-MPQ Part B VAS consists of a line 0 to 100 millimeters (mm) in length; range is (no pain) to 100 mm (worst possible pain). Subjects placed a mark indicating the intensity of their pain. Distance from left-hand end of line was measured and entered on Case Report Form (CRF) as score in mm. Higher score indicates greater level of pain.|Week 12|ITT||millimeters||Standard Error|Least Squares Mean
723571|NCT00313820|Secondary|Weekly Mean Sleep Interference Score From Daily Sleep Diary (Daily Sleep Interference Scale [DSIS])|DSIS: subject rated 11-point numeric scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication. Endpoint calculated as mean of last 7 available scores.|Week 1, Week 2, Week 3, Week 6, Week 9, and Week 12|ITT; (n) = number of subjects with analyzable data at observation for pregabalin and placebo, respectively; endpoint = Week 12 or ET.||scores on scale||Standard Error|Least Squares Mean
723572|NCT00313820|Secondary|Number of Subjects With at Least a 50% Reduction From Baseline in Mean Pain Score at Endpoint|50% Responder Yes = number of subjects with 50% reduction in mean pain score from baseline to observation; 50% reduction calculated as [(T minus B) divided by B multiplied by 100] < = negative 50. T = endpoint mean pain score (obtained from last 7 available scores from DPRS); B = baseline mean pain score (obtained from average of last 7 daily scores from DPRS). 50% Responder No indicates number of subjects that did not reach 50% reduction in mean pain score.|Baseline, Week 12|ITT; endpoint = Week 12 or ET||participants|||Number
723573|NCT00313820|Secondary|Number of Subjects With at Least a 30% Reduction From Baseline in Mean Pain Score at Endpoint|30% Responder Yes = number of subjects with 30% reduction in mean pain score from baseline to observation; 30% reduction calculated as [(T minus B) divided by B multiplied by 100] < = negative 30. T = endpoint mean pain score (obtained from last 7 available scores from DPRS); B = baseline mean pain score (obtained from average of last 7 daily scores from DPRS). 30% Responder No indicates number of subjects that did not reach 30% reduction in mean pain score.|Baseline, Week 12|ITT; endpoint = Week 12 or ET||participants|||Number
723574|NCT00313820|Secondary|Pain Score as Measured by DPRS|Weekly mean pain score measured by DPRS: subject rated 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain. Self-assessment performed daily on awakening prior to taking study medication.|Week 1, Week 2, Week 3, Week 6, Week 9, and Week 12|ITT; (n) = number of participants with analyzable data at observation for pregabalin and placebo, respectively; weeks as specified in timeframe through Week 12 [ET]||scores on scale||Standard Error|Least Squares Mean
723575|NCT00313820|Primary|Mean Pain Score at Endpoint as Measured by Daily Pain Rating Scale (DPRS)|Mean pain score obtained from last 7 available DPRS scores up to and including day of Week 12 visit or early termination (ET) equivalent. DPRS: subject rated 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain. Self-assessment performed daily on awakening prior to taking study medication.|Up to Week 12|Intent to Treat (ITT): received at least 1 dose study medication and completed at least 1 post-baseline assessment. Endpoint = Week 12 or ET||scores on scale||Standard Error|Least Squares Mean
723576|NCT00324649|Secondary|Percentage of Participants Who Discontinue the Study Prematurely (Before Week 48) Due to Adverse Events.||48 weeks|Treated participants.||Percentage of participants|||Number
723577|NCT00324649|Secondary|Percentage of Participants With Any Adverse Event|"Participants with treatment-emergent adverse events were analyzed. Adverse events were defined as any untoward medical occurrence in a clinical investigation subject administered a medicinal product and which did not necessarily have a causal relationship with study treatment, and were categorized using the Medical Dictionary for Regulatory Activities (MedDRA) Version 11.
Treatment-emergent adverse events were events that met one of the following criteria:
Began or worsened in severity or relationship to study drug, on or after the date of the first dose of study drug and on or before the date of the last dose of study drug plus 30 days.
Had no recorded start date."|72 weeks|Treated participants.||Percentage of participants|||Number
723588|NCT00324649|Secondary|Percentage of Participants Who Maintain Confirmed HIV-1 RNA < 50 Copies/mL||48 weeks|Treated participants. Missing values were treated as failure (i.e., as HIV-1 RNA greater than or equal to 50 copies/mL).||Percentage of participants|||Number
723589|NCT00324649|Secondary|Percentage of Days for Which Participants Were Compliant With Study Drug|Compliance = [1 - [(sum of days with a missed dose [per Question 6 study medication assessment questionnaire (SMAQ)])/(sum of days between SMAQ visits)]] *100 for visits with SMAQ data. An assessable visit is one where the number of missed days was reported [Question 6] and the number of days between SMAQ visits could be calculated.|Baseline to Week 72|Treated participants.||Percentage of days with compliance||Inter-Quartile Range|Median
723590|NCT00324649|Secondary|Change From Baseline in Lactate Concentration|Change = Week 48 value minus baseline value.|Baseline to Week 48|Treated participants. Missing values were excluded.||mmol/L||Inter-Quartile Range|Median
723591|NCT00324649|Secondary|Change From Baseline in the Mitochondrial DNA/Nuclear DNA Ratio (Lymphocytes)|Change = Week 48 value minus baseline value.|Baseline to Week 48|Treated participants. Missing values were excluded.||Ratio||Inter-Quartile Range|Median
723592|NCT00324649|Secondary|Change From Baseline in the Mitochondrial DNA/Nuclear DNA Ratio (Oral Mucosa)|Change = Week 48 value minus baseline value.|Baseline to Week 48|Treated participants. Missing values were excluded.||Ratio||Inter-Quartile Range|Median
723593|NCT00324649|Primary|Change From Baseline in Limb Fat at Week 48|Limb fat was measured by DEXA. Change = Week 48 value minus baseline value.|Baseline to Week 48|Treated participants. Number of participants analyzed is those with baseline and post-baseline DEXA data. Last post-baseline observation carried forward (LOCF) method was used if the Week 48 limb fat value was missing.||grams (g)||Inter-Quartile Range|Median
723594|NCT00324675|Secondary|HbA1c||at baseline and after 6 and 12 mo||||||
723595|NCT00324675|Secondary|Adverse Event||every month or at occurence||||||
723596|NCT00324675|Secondary|Renal Function||at abseline and after 6 and 12 mo||||||
723597|NCT00324675|Secondary|Renal Hemodynamic||at baseline and after 6 and 12 mo of tretament||||||
723598|NCT00324675|Primary|Proteinuria||at baseline and after 6 and 12 mo of treatment|per protocol||g/24hr||Standard Error|Mean
723599|NCT00324701|Secondary|SCID: Structured Clinical Interview for the DSM-IV|Structured clinical interview for the DSM-IV (SCID) administered by raters blind to subject condition. Structured interviews included psychiatric assessment for depression, PTSD, panic, generalized anxiety disorder (GAD) evaluated using the DSM-IV.|12 months|Participants completing 12 month assessment||% participants with treatment response||95% Confidence Interval|Number
723600|NCT00324701|Primary|At Least a 50% Improvement From Baseline to Post-treatment on the Geriatric Depression Scale (GDS)|The Geriatric Depression Scale (GDS) is a 30-item self-report assessment designed specifically to identify depression in the elderly. Participants are asked to respond by answering yes or no in reference to how they felt over the past week. Higher scores indicate more severe depression.|8 week & 12 months|Participants completing 8 week and 12 month assessments.||% participants with treatment response||95% Confidence Interval|Number
723601|NCT00324740|Primary|Objective Response Rate|The phase II portion of the study ended early therefore the primary outcome of the objective response rate was not assessed.|Tumor measurements every 8 weeks until disease progression||||||
723602|NCT00324740|Primary|Maximum Tolerated Dose of Vorinostat in Combination With Isotretinoin|Hematologic: Any Grade 3/4 Thrombocytopenia and/or Grade 3/4 Neutropenia Non-Hematologic: Any >/= Grade3 non-hematologic toxicity considered by the investigator to be possibly related to study drug and/or any non-hematologic toxicity that results in a dose-delay of more than three weeks.|Once 2 DLT events occur in patients, the preceding dose will be designated the maximum tolerated dose (MTD).|The recommended phase II dose is vorinostat (300 mg bid) + Isotretinoin (0.5 mg/kg PO bid) three days per week||mg/kg BID|||Number
723603|NCT00324740|Primary|Dose Limiting Toxicities Associated With Vorinostat Concurrently Administered With Isotretinoin|Defined as the occurrence of one or more of the following toxicities as graded by the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0|Course 1, up to 28 days|||participants|||Number
723604|NCT00324857|Secondary|To Examine and Compare the Effectiveness of the Proposed Intervention Strategies to Increase AA Patient Likelihood of Receiving Knee Replacement Within 12 Months of the Intervention.||12 months||||||
723605|NCT00324857|Primary|Change in Willingness.|"Change in willingness assessed using the willingness likert scale. The primary outcome was change in patient willingness to undergo total knee replacement. The willingness rating is a 5-category ordinal response scale from definitely not willing to definitely willing which was later dichotomized for analysis. Responses definitely and probably willing were combined and compared to unsure, probably not willing, and definitely not willing combined."|Follow-Up|Study sample reflects the African American, predominantly male population of the VA health care system||participants|||Number
723606|NCT00324870|Other Pre-specified|Clinical Response Rate of SAHA and Bevacizumab|To determine the clinical response rate of SAHA and Bevacizumab in patients with metastatic renal cell carcinoma.|7 years||||||
723607|NCT00324870|Other Pre-specified|Maximum Tolerated Dose|Determine the maximum tolerated dose of SAHA|18 months from first patient dosing||||||
723608|NCT00324870|Primary|Progression-free Survival Assessed by Response Evaluation Criteria for Solid Tumors (RECIST) (Phase II)|Estimated by Kaplan-Meier method|At 6 months|Progression free survival was summarized for the entire sample (n=37). The median survival times and 6-month survival rates are estim. based on the KP curve,w/ corresp. 95% confidence intervals using the log-log method. Conducted in SAS v9.3(Cary, NC). Progr.free survival time is calc. from date of first tx until date of progres./death or last fu.||percent||95% Confidence Interval|Number
723611|NCT00324961|Secondary|Time to Protocol-defined Complete Response Over a 104-week Treatment Period|Time to response was defined as the time to participants achieving protocol-defined complete response at week 104 from baseline. Protocol-defined complete response was an HBV DNA level ≤ 300 copies/mL by Roche COBAS AMPLICOR HBV MONITOR Test and ALT normalized for two consecutive visits at least 3 months apart.|Baseline to Week 104|Intent-to-Treat (ITT) Population: all participants who actually received the study medication at least once.||days||Standard Deviation|Mean
723612|NCT00324961|Secondary|Number of Participants Achieving Complete Response at Week 104|Complete response was defined as an HBV DNA level ≤ 300 copies/mL by the Roche COBAS AMPLICOR HBV MONITOR Test and ALT normalized for two consecutive visits at least 3 months apart.|Week 104|Intent-to-Treat (ITT) Population: all participants who actually received the study medication at least once.||participants|||Number
723613|NCT00324961|Secondary|Number of Participants Achieving HBV DNA ≤300 Copies/mL Over Time|Hepatitis B Virus (HBV) DNA level is tested in blood serum by real-time Polymerase Chain Reaction with the lower limit of detection (LLD) as 300 copies/milliliter in a central laboratory.|Weeks 13, 26, 39, 52, 65, 78, 91, and 104|Intent-to-Treat (ITT) Population: all participants who actually received the study medication at least once. Missing data were not included in statistical analysis.||participants|||Number
723614|NCT00324961|Secondary|Number of Participants With ADV-associated Resistance at Week 104|Week 104 serum samples from participants who reached a HBV DNA breakthrough were assessed for the development of ADV (Adefovir dipivoxil) mutations (N236T and A181V) in the HBV polymerase. HBV DNA breakthrough was defined as an increase in HBV DNA level by 1 log10 copies/mL or more from the treatment nadir during Weeks 0 to 104.|Week 104|Intent-to-Treat (ITT) Population: all participants who actually received the study medication at least once.||participants|||Number
723615|NCT00324961|Secondary|Number of Participants Achieving HBsAg Loss and HBsAg Seroconversion at Week 104|HBsAg loss and HBsAg seroconversion (HBsAg loss and HBsAb detected) were assessed for all participants who were HBeAg negative at Weeks 0 and 104. Confirmed HBsAg loss was defined as undetectable HBeAg.|Week 104|Intent-to-Treat (ITT) Population: all HBeAg negative participants who actually received the study medication at least once||participants|||Number
723616|NCT00324961|Secondary|Number of Participants Achieving ALT Normalization at Week 104|Serum alanine aminotransferase (ALT) normalization was defined as a serum ALT level at or below the upper limit of the normal (ULN) range after a baseline value above the ULN, as determined using central laboratory ranges.|Week 104|Intent-to-Treat (ITT) Population: all HBeAg negative participants who actually received the study medication at least once. A total of 435 participants had a baseline ALT value above the ULN.||participants|||Number
723617|NCT00324961|Secondary|Change From Baseline in Median Serum HBV DNA Over Time|The HBV DNA level was tested in blood serum by real-time PCR with the LLD as 300 copies/mL at baseline and Weeks 13, 26, 39, 52, 65, 78, 91, and 104 in a central laboratory.|Baseline and Weeks 13, 26, 39, 52, 65, 78, 91, and 104|Intent-to-Treat (ITT) Population: all HBeAg negative participants who actually received the study medication at least once.||log10 copies/mL||Full Range|Median
723618|NCT00324961|Secondary|Liver Histology Scores in HBeAg Negative Participants With Two Sequential Liver Biopsies During the Period of 104 Weeks|The Knodell/histological activity index (HAI) scoring system that represents the sum of scores for periportal bridging necrosis (0–10: none=0, moderate piecemeal necrosis plus bridging necrosis=5, multilobular necrosis=10); interlobular degeneration and focal necrosis (0–4: none=0, marked=4); portal inflammation (0–4: none=0, marked=4) and fibrosis (0–4: none=0, fibrous portal expansion=1, bridging fibrosis=3, cirrhosis=4) was carried out by two independent pathologists in the HBeAg negative participants with 2 sequential liver biopsies during the period of 104 weeks.|Baseline to Week 104|HBeAg negative chronic hepatitis B participants who underwent liver biopsy at Week 48||Points on a scale||Standard Deviation|Mean
723619|NCT00324961|Secondary|Number of Participants Achieving Histological Improvement After the 104-week Treatment|Histological improvement (defined as ≥2 point reduction in the Knodell necroinflammation score without worsening fibrosis) was assessed by 2 independent pathologists in the HBeAg-negative participants who underwent 2 sequential liver biopsies at baseline and week 104/withdrawal. The Knodell/histological activity index (HAI) scoring system represents the sum of scores for periportal, bridging necrosis (0–10: none=0, multilobular necrosis=10), interlobular degeneration and focal necrosis (0–4: none=0, marked=4), portal inflammation (0–4: none=0, marked=4), and fibrosis (0–4: none=0, cirrhosis=4)|Week 104|HBeAg negative chronic hepatitis B participants who underwent liver biopsy at Week 104||participants|||Number
723620|NCT00324961|Primary|Number of Participants Achieving HBV DNA ≤300 Copies/mL at Week 104|Hepatitis B Virus (HBV) DNA level is tested in blood serum by real-time Polymerase Chain Reaction with the lower limit of detection (LLD) as 300 copies/milliliter in a central laboratory.|Week 104|Intent-to-Treat (ITT) Population: all HBeAg participants who actually received the study medication at least once. Participants with missing data were not included in the analysis.||participants|||Number
723621|NCT00324987|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Up to 7 years|Eligible patients who received any treatment and were assessed for adverse events are included in this summary.||Participants|||Number
723622|NCT00324987|Secondary|Central-review Based Progression-free Survival (CRb-PFS)|From date of registration (defined as date of randomization) to date of first documentation of one of the following events: death; first documentation of progression based on central review of the appropriate computed tomography (CT) or magnetic resonance imaging (MRI) scans; development of new lesions or disease not identified on CT or MRI; or symptomatic deterioration. Patients not experiencing any of these events will be censored at last date of contact.|up to 7 years|Data not collected as study accrued only 2% of the 572 patients planned. No scientific conclusions were forthcoming because of the small number of patients entered in the study.|||||
723623|NCT00324987|Secondary|Overall Survival|From date of registration (defined as date of randomization) to date of death due to any cause. Patients last known to be alive are censored at last date of contact. Note: median was not reached in the Imatinib arm due to limited follow-up data.|up to 7 years|No scientific conclusions were forthcoming because of the small number of patients entered in the study.||months||95% Confidence Interval|Median
723636|NCT00325130|Primary|Geometric Mean Titers (GMTs) for Pertussis Anti-Filamentous Hemagglutinin) (Anti-FHA) One Month Postvaccination (Week 4 Postdose 1) With ADACEL™||7 Months|"Per-protocol population: subjects must
have no major protocol violations and must have post-vaccination data."||ELISA units/mL||95% Confidence Interval|Geometric Mean
723637|NCT00325130|Primary|Geometric Mean Titers (GMTs) for Pertussis Anti-Pertussis Toxin (Anti-PT) One Month Postvaccination (Week 4 Postdose 1) With ADACEL™||7 Months|"Per-protocol population: subjects must
have no major protocol violations and must have post-vaccination data."||ELISA units/mL||95% Confidence Interval|Geometric Mean
723624|NCT00324987|Primary|Progression Free Survival|From date of registration (defined as date of randomization) to date of first observation of progressive disease, death due to any cause or symptomatic deterioration. Patients last known to be alive and progression free are censored at last date of contact. Progression is defined as one or more of the following: 20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy), provided at least one target lesion does NOT demonstrate uniform hypoattenuation over > 90% of maximal cross sectional area; unequivocal progression of non-measurable disease; appearance of new lesion/site that is not uniformly hypoattenuating; a hyperattenuating region within a previously cystic/uniformly hypoattenuating lesion will be considered progressive disease if hyperattenuating region is either >= 1 cm in longest diameter or round/oval and forms acute margins with border of target lesion; death due to disease.|Up to 7 years|No scientific conclusions were forthcoming because of the small number of patients entered in the study.||months||95% Confidence Interval|Median
723625|NCT00324987|Secondary|Response Rate|Confirmed response (CR) is two or more objective statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration. Partial response (PR) is two or more objective statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration. Unconfirmed CR is one objective status of CR documented before progression or symptomatic deterioration but not qualifying as CR or PR. Unconfirmed PR is one objective status of PR documented before progression or symptomatic deterioration but not qualifying as CR, PR or unconfirmed CR.|Up to 7 years|Only eligible and evaluable patients included. No scientific conclusions were forthcoming because of the small number of patients entered in the study.||Participants|||Count of Participants
723626|NCT00325039|Secondary|Bother as Measured by the Urogenital Distress Inventory (UDI) at 12 Months|Urogenital Distress Inventory (UDI) scores range from 0 to 300 with higher scores indicating greater distress. Scores are changes from baseline to the 12 month visit (baseline - 12 months)|12 months|This is the number of participants who had complete UDI information at the 12 month visit.||units on a scale||Standard Deviation|Mean
723627|NCT00325039|Secondary|Change in Quality of Life From Baseline to 12 Months|Scores on the Incontinence Impact Questionnaire range from 0 to 400 with higher scores indicating greater impact. The scores are changes from baseline to the 12 month visit (baseline - 12 months).|Baseline - 12 months|These are the number of patients with available quality of life data at the 12 month visit.||units on a scale||Standard Deviation|Mean
723628|NCT00325039|Primary|Subjective Treatment Success at 12 Months|Absence of self-reported symptoms of stress-type urinary incontinence, as assessed with the use of the Medical, Epidemiological and Social Aspects of Aging (MESA) questionnaire (responded never to all 9 MESA questions), no leakage recorded in a 3-day voiding diary and no retreatment for stress incontinence including behavioral, pharmacologic or surgical treatment.|12 months|Because the study was designed as an equivalence trial, the outcome was assessed only in women treated per-protocol (n=291 in the Retropubic arm and n=292 in the transobturator arm).||percentage of participants|||Number
723629|NCT00325039|Secondary|Patient Satisfaction at 12 Months|"Patient satisfaction was assessed at the 12 month visit with the questions, how satisfied or dissatisfied are you with the result of bladder surgery related to urine leakage? Possible responses were completely satisfied, mostly satisfied, neutral, mostly dissatisfied, and completely dissatisfied. Completely and mostly satisfied were reported as satisfied and neutral, most dissatisfied and completely dissatisfied as not satisfied."|Follow-Up|This is the number of women who answered the satisfaction questions at the 12 month visit (n=280 attended the 12 month visit in the retropubic arm and n=285 in the transobturator arm)||percentage of participants analyzed|||Number
723630|NCT00325039|Primary|Objective Treatment Success at 12 Months|"Objective treatment success: negative stress test, negative pad test, and no retreatment for stress urinary incontinence (SUI) including behavioral, pharmacologic or surgical procedures
A provocative stress test standardized to volume and position is performed for direct observation of urine leakage. Observed urine loss from the urethra coincidental with the Valsalva maneuver or cough is a positive test; a negative test indicates no urine loss. Pad testing quantifies the amount of urine involuntarily lost and is used to reflect everyday incontinence; it is negative if loss is <15g/24 hrs."|12 months|Because the study was designed as an equivalence trial, the outcome was assessed only in women treated per-protocol (n=291 and n=292 in RMUS, TMUS, respectively).||percentage of participants|||Number
723631|NCT00325078|Other Pre-specified|Gut Immune Cell Types and Their Cytokine Profile|Gut Immune cell types and their cytokine profile|1 year||||||
723632|NCT00325078|Primary|Efficacy of Treatment With Study Drug|Measured participant Crohn’s disease Activity Index (CDAI) values. The CDAI is a tool comprised of clinical and laboratory factors such as stool frequency, consistency, abdominal pain, general well being, weight and blood profile as an objective measure of disease activity. A higher score corresponds to greater severity of inflammatory bowel disease; severe disease conventionally defined as >450, a remission as <150, and a response to treatment as a fall of CDAI of >70 points. Infections and IBD are not expected in healthy control subjects. The greater the score, the more severe the disease, and a score of less than 5 represents clinical remission.|Baseline, 1 year|All participants in the Treatment and Observation Arms with collected CDAI data. The CDAI, a tool validated for Crohn’s disease is not applicable to healthy donors or CGD patients without IBD, and therefore not measured in the Control participants.||Crohn's disease activity Index|||Number
723633|NCT00325078|Primary|Safety of Study Drug|Number of Infections from Baseline to 1 year|Baseline to 1 year|The volunteer group includes patients with chronic granulomatous disease as well as healthy normal volunteers as controls. Infection rates only pertain to and are counted in subjects with underlying immunodeficiency (chronic granulomatous disease).||infections|||Number
723634|NCT00325130|Primary|Geometric Mean Titers (GMTs) for Pertussis Anti-Fimbrial Agglutinogens 2/3 (Anti-FIM) One Month Postvaccination (Week 4 Postdose 1) With ADACEL™||7 Months|"Per-protocol population: subjects must
have no major protocol violations and must have post-vaccination data."||ELISA units/mL||95% Confidence Interval|Geometric Mean
723635|NCT00325130|Primary|Geometric Mean Titers (GMTs) for Pertussis Anti Pertactin (Anti-PRN) One Month Postvaccination (Week 4 Postdose 1) With ADACEL™||7 Months|"Per-protocol population: subjects must
have no major protocol violations and must have post-vaccination data."||ELISA units/mL||95% Confidence Interval|Geometric Mean
724612|NCT00345605|Primary|Measures of Liver Function: AST and ALT|Plasma aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels were measured.|Measured after each 1-week treatment period|||IU/L||Standard Error|Mean
723638|NCT00325130|Primary|Geometric Mean Titers (GMTs) for Anti-HPV 18 at Week 4 Postdose 3 (7 Months) of GARDASIL™||7 Months|"Per-protocol population: subjects must
have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have
post-vaccination data."||mMU/mL||95% Confidence Interval|Geometric Mean
723639|NCT00325130|Primary|Geometric Mean Titers (GMTs) for Anti-HPV 16 at Week 4 Postdose 3 (7 Months) of GARDASIL™||7 Months|"Per-protocol population: subjects must
have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have
post-vaccination data."||mMU/mL||95% Confidence Interval|Geometric Mean
723640|NCT00325130|Primary|Geometric Mean Titers (GMTs) for Anti-HPV 11 at Week 4 Postdose 3 (7 Months) of GARDASIL™||7 Months|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.||mMU/mL||95% Confidence Interval|Geometric Mean
723641|NCT00325130|Primary|Geometric Mean Titers (GMTs) for Anti-HPV 6 at Week 4 Postdose 3 (7 Months) of GARDASIL™||7 Months|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.||mMU/mL||95% Confidence Interval|Geometric Mean
723642|NCT00325130|Primary|Number of Subjects Who Achieved Acceptable Levels of Titers to Tetanus (Tetanus ≥ 0.1 IU/mL) One Month Postvaccination (Week 4 Postdose 1) With ADACEL™||7 Months|Per-protocol population: subjects must have no major protocol violations and must have post-vaccination data.||Participants|||Number
723643|NCT00325130|Primary|Number of Subjects Who Achieved Acceptable Levels of Titers (Diphtheria ≥ 0.1 IU/mL) to Diphtheria One Month Postvaccination (Week 4 Postdose 1) With ADACEL™||7 Months|Per-protocol population: subjects must have no major protocol violations and must have post-vaccination data.||Participants|||Number
723644|NCT00325130|Primary|Number of Subjects Who Achieved a Four-fold Rise in Titers to Meningococcal Serogroup Y One Month Postvaccination With Menactra™||7 Months|Per-protocol population: subjects must have no major protocol violations and must have post-vaccination data.||Participants|||Number
723645|NCT00325130|Primary|Number of Subjects Who Achieved a Four-fold Rise in Titers to Meningococcal Serogroup W-135 One Month Postvaccination (Week 4 Postdose 1) With Menactra™||7 Months|Per-protocol population: subjects must have no major protocol violations and must have post-vaccination data.||Participants|||Number
723646|NCT00325130|Primary|Number of Subjects Who Achieved a Four-fold Rise in Titers to Meningococcal Serogroup C One Month Postvaccination (Week 4 Postdose 1) With Menactra™||7 Months|Per-protocol population: subjects must have no major protocol violations and must have post-vaccination data.||Participants|||Number
723647|NCT00325130|Primary|Number of Subjects Who Achieved a Four-fold Rise in Titers to Meningococcal Serogroup A One Month Postvaccination (Week 4 Postdose 1) With Menactra™||7 Months|Per-protocol population: subjects must have no major protocol violations and must have post-vaccination data.||Participants|||Number
723648|NCT00325130|Primary|Number of Subjects Who Seroconverted for HPV Type 18 (HPV 18≥ 24 mMU/mL) by Week 4 Postdose 3 (7 Months)||7 Months|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.||Participants|||Number
723649|NCT00325130|Primary|Number of Subjects Who Seroconverted for HPV Type 16 (HPV 16 ≥ 20 mMU/mL) by Week 4 Postdose 3 (7 Months)||7 Months|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.||Participants|||Number
723650|NCT00325130|Primary|Number of Subjects Who Seroconverted for HPV Type 11 (HPV 11 ≥ 16 mMU/mL) by Week 4 Postdose 3 (7 Months)||7 Months|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.||Participants|||Number
723651|NCT00325130|Secondary|Acceptable Safety Profile||15 days post injection||||||
723652|NCT00325130|Primary|Number of Subjects Who Seroconverted for Human Papillomavirus (HPV) Type 6 (HPV 6 ≥ 20 mMU/mL) by Week 4 Postdose 3 (7 Months)||7 Months|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.||Participants|||Number
723653|NCT00325143|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Month 0 up to Month 21)|The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects for whom data were available.||Subjects|||Number
723654|NCT00325143|Secondary|Number of Subjects Reporting Any Large Swelling Reactions|A large swelling reaction was defined as swelling with a diameter greater than (>) 50 millimeters (mm), noticeable diffuse swelling or noticeable increase of limb circumference.|At Month 15, post-booster dose|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.||Subjects|||Number
723655|NCT00325143|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 31-day (Days 0-30) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.||Subjects|||Number
723656|NCT00325143|Primary|Number of Subjects Reporting Any Solicited Local and General Symptoms|Assessed solicited local and general symptoms were pain, redness, swelling, drowsiness, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade.|During the 4-day (Days 0-3) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.||Subjects|||Number
723657|NCT00325156|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Subjects|||Number
723658|NCT00325156|Secondary|Number of Subjects Reporting Large Injection Site Swelling|A large swelling reaction was defined as swelling with a diameter greater than (>) 50 millimeters (mm), noticeable diffuse swelling or noticeable increase of limb circumference.|At Month 18, post-booster dose|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had filled-in the symptom sheet.||Subjects|||Number
723659|NCT00325156|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 30-day (Days 0-29) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Subjects|||Number
723660|NCT00325156|Primary|Number of Subjects Reporting Any Solicited Local and General Symptoms|Assessed solicited local and general symptoms were pain, redness, swelling, drowsiness, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C )], irritability and loss of appetite. Any was defined as any report of the specified symptom irrespective of intensity grade and relationship to vaccination.|During the 4-day (Days 0-3) post-vaccination period, across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had filled-in the symptom sheet.||Subjects|||Number
723661|NCT00325195|Secondary|Change in Patient Reported Outcomes of Pain, Physical Function and Quality of Life|Health Assessment Questionnaire(HAQ: VAS pain scale where 0 (no pain)-100 (severe pain); HAQ disability index (HAQ-DI) on a scale from 0(no disability) to 3 (completely disabled), and a unit change of > or =0.22 is considerd a mimimal clinically important difference(MCID). SF-36 Physical Component Summary Score (SF36-PCS), a composite score where 0 is the worst score and 100 the best possible, and where a change of > or =2.5 units in the PCS is considered a MCID.|Baseline to Final Visit (Month 6 or LOCF)|Number of participants analyzed was based upon the number who had baseline and at least one follow-up assessment, with the final visit for each subject included (LOCF).||Units on a scale||Standard Deviation|Mean
723662|NCT00325195|Secondary|Change in Number of Tender Joints|Change from Baseline to Month 6 (or last observation carried forward) in number of tender joints per participant|Baseline and Final Visit (Month 6 or LOCF)|All ITT participants with baseline and at least one post-baseline assessment were included in analysis. LOCF was used for participants dropping out early.||Tender joints||Standard Deviation|Mean
723663|NCT00325195|Secondary|Change in Number of Swollen Joints|Change from Baseline to Month 6 (or last observation carried forward)in number of swollen joints per subject. Values were inputed using last observation carried forward analysis for subjects who did not complete the studies.|Baseline and Final Visit (Month 6 or LOCF)|All ITT participants with baseline and at least one post-baseline assessment were included in analysis. LOCF was used for participants dropping out early.||Swollen joints||Standard Deviation|Mean
723664|NCT00325195|Secondary|Percentage of Subjects With Gout Flare Per 3-month Period|Percent of participants reporting a gout flare during Months 1-3 and Months 4-6. Denominator during the respective period was based upon number of participants during that period.|Months 1-3 and Months 4-6|Number analyzed in each period was based upon number of participants remaining in study during the assessed treatment period: 85/84/43 in Months 1-3 and 69/69/43 in Months 4-6||Percent subjects reporting flares|||Number
723665|NCT00325195|Secondary|Reduction in Tophus Burden|percentage of tophaceous subjects who demonstrated a complete resolution (100 % decrease in measured area or complete disappearance)of at least one tophus in the absence of other tophus progression or new tophi, as assessed by a blinded Central Reader using standardized digital photographs and image analysis software.|Baseline and Final Visit (6 months or LOCF)|Number of participants analyzed was based upon the number of patients who had one or more tophus at Baseline, as determined by the PI, AND who had at least one follow-up assessment, with the final visit for each subject included (last observation carried forward).||Percent subjects with resolved tophus|||Number
723666|NCT00325195|Primary|Plasma Uric Acid (PUA) Responder|PUA Responder was defined as a participant who achieved and maintained plasma uric acid concentrations < 6 mg/dL for at least 80% of the time during months 3 and 6 combined. Participants who withdrew from the study before month 6 were considered non-responders.|Months 3 and 6|Modified ITT (all patients receiving at least one dose of study drug). Participants dropping out before Week 25 were imputed as Non-Responders||Participants|||Number
723667|NCT00325234|Secondary|Number of Participants With Adverse Events (AE)|A listing of adverse events is presented in the Reported Adverse Event Module.|every cycle up to twenty-one 21-day cycles (plus 30 days of follow-up)|All randomized participants who received at least one dose of study drug.||participants|||Number
723668|NCT00325234|Secondary|Time to Response|Time to response (Complete Response(CR) or Partial Response (PR) is defined as the time from the date of study enrollment to the first date when the measurement criteria are met for complete response or partial response (whichever status is recorded first). CR=Disappearance of target lesions lesions. PR=≥30% size decrease of lesions.|Baseline to response (up to 7.8 months)|All randomized participants with CR or PR.||Months||95% Confidence Interval|Median
723669|NCT00325234|Secondary|Time To Treatment Failure (TTTF)|TTTF is defined as the time from date of study enrollment to the first documented date of death, PD, or study treatment discontinuation due to adverse event (AE). For participants not known to have discontinued as of the data cut-off date, TTTF is censored at the last contact date. For participants who discontinued for reasons other than death, PD, or AE, TTTF is censored at the date of discontinuation.|Baseline to end of treatment (up to 21.9 months)|All randomized participants||Months||95% Confidence Interval|Median
724212|NCT00336817|Primary|Number of Participants With Bone Marrow Suppression|Number of participants with: Thrombocytopenia (<50,000 mm3), Leukopenia (< 2000 mm3), absolute neutrophils count ( <1000 mm3) or hemoglobin ( < 7.0 g/dL)|12 weeks|||participants|||Number
723670|NCT00325234|Secondary|Time to Progressive Disease (PD)|Time to PD is defined as the time from the date of study enrollment to the first documented date of PD or death from study disease. For participants who die from causes other than study disease and without PD, time to PD was censored at the date of death. For participants not known to have died as of the data cut-off date and do not have PD, time to PD was censored at the last contact date. For participants who received subsequent chemotherapy (after discontinuation from the study chemotherapy) prior to disease progression, time to PD was censored at the date of subsequent chemotherapy.|Baseline to measured PD (up to 25.1 months)|All randomized participants.||Months||95% Confidence Interval|Median
723671|NCT00325234|Secondary|Duration of Response (DOR)|DOR-RECIST criteria of (Complete Response [CR =Disappearance of lesions] or Partial Response [PR=≥30% size decrease of lesions]) is defined as time from the date when measurement criteria are met for CR or PR until the date of first observation of progressive disease (PD) or death from study disease. For participants who die from causes other than study disease and without PD, DOR will be censored at the date of death. For participants who have not died as of the data cut-off date who are without PD, DOR was censored at last contact date.|Time of response to progressive disease (up to 19 months)|All randomized participants with CR or PR.||Months||95% Confidence Interval|Median
723672|NCT00325234|Primary|Tumor Response Rate|Participants with best overall response determined from complete response (CR) or partial response (PR) according to Response Criteria in Solid Tumors (RECIST) criteria. For CR or PR, best response must be confirmed. A second assessment performed at 28 days. Two determinations of CR before progression required for rate to=CR. Evaluations include: CR=Disappearance of lesions. PR=≥30% size decrease of lesions. Progressive Disease (PD)=≥20% size increase of lesions. Stable Disease (SD)=Not enough shrinkage for PR nor enough increase for PD. Overall Response Rate=PR+CR/Qualified Participants*100.|Baseline up to 30 days of follow-up after 21 cycles of treatment|All randomized patients who qualified for tumor response analysis by the following criteria: Females with histologic or cytologic diagnosis of advanced breast cancer previously treated with anthracyclines and taxanes. No concurrent antitumor therapy. Presence of measurable disease as defined by RECIST. Treatment with at least 1 dose of study drug.||percentage of participants||95% Confidence Interval|Number
723673|NCT00325403|Post-Hoc|Six Minute Walk Distance (6MWD) for the Entire Study Population|"Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 4, correlates with the historical clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS). This outcome measure was assessed using data from all subjects enrolled in the study, regardless of tablet strength availability at randomization.
The six minute walk test was to be conducted 3 to 6 house after the previous dose of study drug.
The Hodges-Lehmann median difference between treatment groups was used to estimate the treatment effect on 6MWD from Baseline to Week 4. A rank-based methodology was used instead of parametric-based methodology to avoid statistical bias caused by extreme outliers resulting from the handling of data that are missing due to death or clinical worsening of PAH. It is a more robust estimator than the between-treatment difference in medians."|Baseline and Week 4|This analysis was performed using data from all subjects enrolled in the study, regardless of tablet strength availability at randomization.||meters||Inter-Quartile Range|Median
723674|NCT00325403|Post-Hoc|Six Minute Walk Distance (6MWD) for the Entire Study Population|"Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 8, correlates with the historical clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS). This outcome measure was assessed using data from all subjects enrolled in the study, regardless of tablet strength availability at randomization.
The six minute walk test was to be conducted 3 to 6 house after the previous dose of study drug.
The Hodges-Lehmann median difference between treatment groups was used to estimate the treatment effect on 6MWD from Baseline to Week 8. A rank-based methodology was used instead of parametric-based methodology to avoid statistical bias caused by extreme outliers resulting from the handling of data that are missing due to death or clinical worsening of PAH. It is a more robust estimator than the between-treatment difference in medians."|Baseline and Week 8|This analysis was performed using data from all subjects enrolled in the study, regardless of tablet strength availability at randomization.||meters||Inter-Quartile Range|Median
723675|NCT00325403|Post-Hoc|Six Minute Walk Distance (6MWD) for the Entire Study Population|"Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 11, a time expected to correlate with trough treprostinil concentration. This outcome measure was assessed using data from all subjects enrolled in the study, regardless of tablet strength availability at the time of randomization.
The six minute walk test was to be conducted 8 to 13 hours after the previous dose of study drug.
The Hodges-Lehmann median difference between treatment groups was used to estimate the treatment effect on 6MWD from Baseline to Week 11. A rank-based methodology was used instead of parametric-based methodology to avoid statistical bias caused by extreme outliers resulting from the handling of data that are missing due to death or clinical worsening of PAH. It is a more robust estimator than the between-treatment difference in medians."|Baseline and Week 11|This analysis was performed using data from all subjects enrolled in the study, regardless of tablet strength availability at randomization.||meters||Inter-Quartile Range|Median
723676|NCT00325403|Post-Hoc|Six Minute Walk Distance (6MWD) for the Entire Study Population|"Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 12, correlates with the historical clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS). This outcome measure was assessed using data collected from all subjects enrolled in the study, regardless of tablet strength availability at randomization.
The six minute walk test was to be conducted 3 to 6 house after the previous dose of study drug.
The Hodges-Lehmann median difference between treatment groups was used to estimate the treatment effect on 6MWD from Baseline to Wk 12. A rank-based methodology was used instead of parametric-based methodology to avoid statistical bias caused by extreme outliers resulting from the handling of data that are missing due to death or clinical worsening of PAH. It is a more robust estimator than the between-treatment difference i"|Baseline and Week 12|This analysis was performed using data from all subjects enrolled in the study, regardless of tablet strength availability at randomization.||meters||Inter-Quartile Range|Median
724221|NCT00336856|Primary|Response Rate (RR)|Percentage of partial responses (PR) + complete responses (CR).|every 6 - 8 weeks, up to 30 months|||percentage of participants||95% Confidence Interval|Number
723677|NCT00325403|Post-Hoc|Six Minute Walk Distance (6MWD) by PAH Etiology: Idiopathic or Heritable PAH|"Exploratory efficacy analyses were to determine the effect of PAH etiology (idiopathic/heritable, associated with collagen vascular disease, and other etiologies) on treatment effect for change in 6MWD.
The Hodges-Lehmann median difference between treatment groups was used to estimate the treatment effect on 6MWD from Baseline to Week 12. A rank-based methodology was used instead of parametric-based methodology to avoid statistical bias caused by extreme outliers resulting from the handling of data that are missing due to death or clinical worsening of PAH. It is a more robust estimator than the between-treatment difference in medians."|Baseline and Week 12|||meters||Inter-Quartile Range|Median
723678|NCT00325403|Post-Hoc|Six Minute Walk Distance by Baseline WHO Functional Classification: I or II|"Exploratory efficacy analyses were to determine the effect of Baseline WHO functional class on treatment effect for change in 6MWD.
The Hodges-Lehmann median difference between treatment groups was used to estimate the treatment effect on 6MWD from Baseline to Week 12. A rank-based methodology was used instead of parametric-based methodology to avoid statistical bias caused by extreme outliers resulting from the handling of data that are missing due to death or clinical worsening of PAH. It is a more robust estimator than the between-treatment difference in medians."|Baseline and Week 12|||meters||Inter-Quartile Range|Median
723679|NCT00325403|Post-Hoc|Six Minute Walk Distance by Baseline WHO Functional Classification III or IV|"Exploratory efficacy analyses were to determine the effect of Baseline WHO functional class on treatment effect for change in 6MWD.
The Hodges-Lehmann median difference between treatment groups was used to estimate the treatment effect on 6MWD from Baseline to Week 12. A rank-based methodology was used instead of parametric-based methodology to avoid statistical bias caused by extreme outliers resulting from the handling of data that are missing due to death or clinical worsening of PAH. It is a more robust estimator than the between-treatment difference in medians."|Baseline and Week 12|||meters||Inter-Quartile Range|Median
723680|NCT00325403|Secondary|Symptoms of PAH|Defined symptoms of PAH including fatigue, dyspnea, edema, dizziness, syncope, chest pain, and orthopnea were assessed at Baseline prior to starting study drug and during the Treatment Phase at Week 12. Severity grade values (i.e., 0, 1, 2, or 3 in increasing severity) were assigned for each symptom.|Baseline and Week 12|||units on a scale||Standard Deviation|Mean
723681|NCT00325403|Secondary|Dyspnea-Fatigue Index|The dyspnea-fatigue index has three components, each rated on a scale of 0 to 4, for the magnitude of the task that evokes dyspnea or fatigue, the magnitude of the pace (or effort) with which the task is performed and the associated functional impairment in general activities. The ratings for each component were added to form an aggregate score, which could range from 0, for the worst condition, to 12, for the best.|Baseline and Week 12|Two subjects (one in the placebo arm and one in the oral treprostinil arm) from the primary analysis population (n=228) did not have a Baseline dyspnea-fatigue index score and were not included in this analysis.||units on a scale||Standard Deviation|Mean
723682|NCT00325403|Secondary|Borg Dyspnea Score|The Borg dyspnea score is a 10-point scale rating the maximum level of dyspnea experienced during the 6-minute walk test. The Borg dyspnea score was assessed immediately following the 6-minute walk test. Scores ranged from 0 (for no shortness of breath) to 10 (for greatest shortness of breath ever experienced).|Baseline and Week 12|||units on a scale||Inter-Quartile Range|Median
723683|NCT00325403|Secondary|World Health Organization Functional Classification for PAH|"Class I: Patients with pulmonary hypertension but without resulting limitation of physical activity. Ordinary physical activity does not cause undue dyspnea or fatigue, chest pain, or near syncope.
Class II: Patients with pulmonary hypertension resulting in slight limitation of physical activity. These patients are comfortable at rest, but ordinary physical activity causes undue dyspnea or fatigue, chest pain or near syncope.
Class III: Patients with pulmonary hypertension resulting in marked limitation of physical activity. They are comfortable at rest. Ordinary activity causes undue dyspnea or fatigue, chest pain, or near syncope.
Class IV: Patients with pulmonary hypertension with inability to carry out any physical activity without symptoms. These patients manifest signs of right heart failure. Dyspnea and/or fatigue may be present even at rest. Discomfort is increased by any physical activity."|Baseline and Week 12|Subjects with a WHO functional classification assessment at Week 12.||participants|||Number
723684|NCT00325403|Secondary|Clinical Worsening Assessment|"Definition of clinical worsening included patients who met at least one of the following criteria during the 12 weeks of the study:
Death (all causes excluding accident)
Transplantation or atrial septostomy
Clinical deterioration as defined by:
Hospitalization as a result of PAH, or
greater than or equal to 20% decrease in 6MWD from Baseline (or too ill to walk) and a decrease in WHO functional class And
Initiation of new PAH specific therapy (i.e., ERA, PDE5-I, prostacyclin)"|Baseline and Week 12|||participants|||Number
723685|NCT00325403|Secondary|Six Minute Walk Distance (6MWD)|"Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 4, correlates with the historical clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS).
The six minute walk test was to be conducted 3 to 6 hours after the previous dose of study drug.
The Hodges-Lehmann median difference between treatment groups was used to estimate the treatment effect on 6MWD from Baseline to Week 4. A rank-based methodology was used instead of parametric-based methodology to avoid statistical bias caused by extreme outliers resulting from the handling of data that are missing due to death or clinical worsening of PAH. It is a more robust estimator than the between-treatment difference in medians."|Baseline and Week 4|Analyses were conducted using the modified intention to treat (mITT), which includes subjects who had access to 0.25 mg tablets at randomization (n=228). All alpha was spent on this subgroup, thereby maintaining an overall type I error rate of 0.05. For sensitivity purposes, efficacy analyses were also performed on all enrolled subjects (n=349).||meters||Inter-Quartile Range|Median
723696|NCT00325416|Primary|Phase II Participants - Overall Response Rate|Re-evaluation of participants who had responsive disease prior to transplant. All changes in monoclonal protein and immunoglobulins will be referenced to those levels obtained immediately prior to cyclophosphamide priming chemotherapy. Complete Response (CR): A CR will be defined as the disappearance of the monoclonal protein by immunofixation studies of serum and urine (100x concentrate) and less than or equal to 5% plasma cells in a bone marrow aspirate. Partial Response (PR): 50% - 74% decrease in the measurable monoclonal protein (M-component from an SPEP and/or UPEP with immunofixation).|Phase II - Phase start at 62 months up to 120 months|Phase II (treatment at MTD) participants with responsive disease prior to transplant.||percentage of participants|||Number
723686|NCT00325403|Secondary|Six Minute Walk Distance (6MWD)|"Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 8, correlates with the historical clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS).
The six minute walk test was to be conducted 3 to 6 hours after the previous dose of study drug.
The Hodges-Lehmann median difference between treatment groups was used to estimate the treatment effect on 6MWD from Baseline to Week 8. A rank-based methodology was used instead of parametric-based methodology to avoid statistical bias caused by extreme outliers resulting from the handling of data that are missing due to death or clinical worsening of PAH. It is a more robust estimator than the between-treatment difference in medians."|Baseline and Week 8|Analyses were conducted using the modified intention to treat (mITT) group, which includes subjects with access to 0.25 mg tablets at randomization (n=228). All alpha was spent on this subgroup, thereby maintaining an overall type I error rate of 0.05. For sensitivity purposes, efficacy analyses were also performed on all enrolled subjects (n=349).||meters||Inter-Quartile Range|Median
723687|NCT00325403|Secondary|Six Minute Walk Distance (6MWD)|"Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 11, a time expected to correlate with trough treprostinil concentration.
The six minute walk test was to be conducted 8 to 13 hours after the previous dose of study drug.
The Hodges-Lehmann median difference between treatment groups was used to estimate the treatment effect on 6MWD from Baseline to Week 11. A rank-based methodology was used instead of parametric-based methodology to avoid statistical bias caused by extreme outliers resulting from the handling of data that are missing due to death or clinical worsening of PAH. It is a more robust estimator than the between-treatment difference in medians."|Baseline and Week 11|Analyses were conducted using the modified intention to treat (mITT) group, which includes subjects with access to 0.25 mg tablets at randomization (n=228). All alpha was spent on this subgroup, thereby maintaining an overall type I error rate of 0.05. For sensitivity purposes, efficacy analyses were also performed on all enrolled subjects (n=349).||meters||Inter-Quartile Range|Median
723688|NCT00325403|Primary|Six Minute Walk Distance (6MWD)|"Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 12, correlates with the historical clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS).
The six minute walk test was to be conducted 3 to 6 hours after the previous dose of study drug.
The Hodges-Lehmann median difference between treatment groups was used to estimate the treatment effect on 6MWD from Baseline to Week 12. A rank-based methodology was used instead of parametric-based methodology to avoid statistical bias caused by extreme outliers resulting from the handling of data that are missing due to death or clinical worsening of PAH. It is a more robust estimator than the between-treatment difference in medians."|Baseline and Week 12|Analyses were conducted using the modified intention to treat (mITT) group, which includes subjects with access to 0.25 mg tablets at randomization (n=228). All alpha was spent on this subgroup, thereby maintaining an overall type I error rate of 0.05. For sensitivity purposes, efficacy analyses were also performed on all enrolled subjects (n=349).||meters||Inter-Quartile Range|Median
723689|NCT00325416|Other Pre-specified|Breast Cancer Resistance Protein (BCRP) Expression|BCRP function will be assayed in multiple myeloma patient bone marrow aspirates obtained before and during high dose chemotherapy. BCRP function is expressed as the change in relative fluorescence in topotecan versus control cells. The distribution of paired differences in BCRP, a continuous variable, will be summarized using descriptive statistics and will be correlated with response and toxicity.|Laboratory study (N/A)||||||
723690|NCT00325416|Other Pre-specified|Genomic DNA Sequence Variations and Correlate With Toxicity to Melphalan and Topotecan|Laboratory Correlates will be summarized using descriptive statistics.|Laboratory study (N/A)||||||
723691|NCT00325416|Other Pre-specified|DNA Topoisomerase I Amount, Activity, or Subcellular Distribution|Laboratory Correlates will be summarized using descriptive statistics.|Laboratory study (N/A)||||||
723692|NCT00325416|Other Pre-specified|Amount, Activity and Subcellular Distribution of Topoisomerase I With Clinical Response and Toxicity|Laboratory Correlates will be summarized using descriptive statistics.|Laboratory study (no specific time points)||||||
723693|NCT00325416|Other Pre-specified|Pharmacokinetic Profiles of High Dose Topotecan and Melphalan|Evaluate the pharmacokinetic profiles of high dose topotecan and melphalan and to investigate the pharmacodynamic relationships with respect to the efficacy and toxicity of this regimen in each age group. Pharmacokinetics of Topotecan: For all dose levels, topotecan levels on Day -4 will be obtained at -15 min, 20 min into 30 min infusion, and 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 8 h, and 23 h after the 30 min infusion. Pharmacokinetics of Melphalan: For all dose levels, melphalan levels during the first day of cytoxan priming chemotherapy and on Day -4 will be obtained before, at the end of the infusion, and 5 minutes (min), 15 min, 30 min, 45 min, 60 min, 90 min, 120 min and 180 min after the infusion. The infusion time for the test dose of melphalan is over 5 min and for the high-dose is over 30 min.|Predetermined time points in protocol||||||
723694|NCT00325416|Secondary|Phase II Overall Survival (OS)|Time from start of treatment until death from any cause.|Phase II - Phase start at 62 months up to 120 months|Phase II (treatment at MTD) evaluable participants at time of analysis||months||95% Confidence Interval|Median
723695|NCT00325416|Secondary|Phase II Event Free Survival (EFS)|Time to treatment failure, which is defined as the time from day 0 to the time of progressive disease. Progressive disease is defined by unequivocal objective evidence and constitutes any of the following: 1). an increase in the total amount of monoclonal protein (M-component from Serum Protein Electrophoresis (SPEP) and/or Urine Protein Electrophoresis (UPEP) with immunofixation) by more than 100% from the lowest level of serum myeloma protein seen after high-dose chemotherapy by serum protein electrophoresis; 2). an increase in the total amount of monoclonal protein above the remission level of the myeloma peak (i.e., an increase of >25% above the lowest level in a 24 hour urine or serum protein; 3). the reappearance of the M-protein if the patient had entered a CR: 4). definite increase in the size (> 1 cm) or number of lytic bone lesions. Compression fractures do not constitute a relapse.|Phase II - Phase start at 62 months up to 120 months|Phase II (treatment at MTD) evaluable participants at time of analysis||months||95% Confidence Interval|Median
723731|NCT00331552|Secondary|Progression-free Survival (Phase II)|Kaplan-Meier estimate assessed at 18 months|18 months|||progression free survival probability||95% Confidence Interval|Number
723697|NCT00325416|Primary|Phase I - Maximum Tolerated Dose (MTD) Level|"MTD of topotecan in multiple myeloma patients receiving autologous transplant when give with melphalan 150 mg/m^2 for three days. Two parallel dose escalations were used, one each for young (18-60 years of age) and elderly patients (> 61 years of age). Elderly patients began a dose level once it had been found to be safe for the young cohort. The purpose of this approach was to expand the access of this trial to elderly patients while ensuring safety.
Phase I Dose Escalation: Level 1 - 20 mg/m^2; Level 2 - 30 mg/m^2; Level 4 - 54 mg/m^2; Level 5 - 72 mg/m^2; Level 6 - 96 mg/m^2; Level 7 - 127.8 mg/m^2; Level 8 - 170.1 mg/m^2"|Phase I - 5 years, 2 months|Phase I Dose Escalation participants.||mg/m^2|||Number
723698|NCT00325442|Secondary|Change in Symptoms of PAH From Baseline to Week 16|Defined symptoms of PAH including fatigue, dyspnea, edema, dizziness, syncope, chest pain, and orthopnea were assessed at Baseline prior to starting study drug and during the Treatment Phase at Week 16. Severity grade values (i.e., 0, 1, 2, or 3 in increasing severity) were assigned for each symptom. The outcome data describes the change in severity values from Baseline to Week 16 for each defined symptom of PAH.|Baseline and 16 weeks|||units on a scale||Standard Error|Mean
723699|NCT00325442|Post-Hoc|Six Minute Walk Distance (6MWD) by Background PAH Therapy: ERA and PDE5-I||Baseline and 16 weeks|The subjects in this subgroup were receiving treatment with an ERA and PDE5-I for 90 days or greater at the time of randomization.||meters||Inter-Quartile Range|Median
723700|NCT00325442|Post-Hoc|Six Minute Walk Distance (6MWD) by Background PAH Therapy: PDE5-I||Baseline and 16 weeks|The subjects in this subgroup were receiving treatment with a PDE5-I for 90 days or greater at the time of randomization.||meters||Inter-Quartile Range|Median
723701|NCT00325442|Post-Hoc|Six Minute Walk Distance (6MWD) by Background PAH Therapy: ERA||Baseline and 16 weeks|The subjects in this subgroup were receiving treatment with an ERA for 90 days or greater at the time of randomization.||meters||Inter-Quartile Range|Median
723702|NCT00325442|Post-Hoc|Six Minute Walk Distance (6MWD) by Lowest Study Drug Dose Strength Available at Randomization: Study Drug Dose 0.25 mg||Baseline and 16 weeks|The subjects in this subgroup had a minimum tablet strength of 0.25 mg for initiation of study drug dosing and dose titration.||meters||Inter-Quartile Range|Median
723703|NCT00325442|Post-Hoc|Six Minute Walk Distance (6MWD) by Lowest Study Drug Dose Strength Available at Randomizaiton: Dose Strength 0.5 mg||Baseline and 16 weeks|The subjects in this subgroup had a minimum tablet strength of 0.5 mg for initiation of study drug dosing and dose titration.||meters||Inter-Quartile Range|Median
723704|NCT00325442|Post-Hoc|Six Minute Walk Distance (6MWD) by Lowest Dose Strength Available at Randomization: Smallest Dose Available 1 mg||Baseline and 16 weeks|The subjects in this subgroup had a minimum tablet strength of 1 mg for initiation of study drug dosing and dose titration.||meters||Inter-Quartile Range|Median
723705|NCT00325442|Post-Hoc|Change in Six Minute Walk Distance (6MWD) From Baseline in Subjects Who Received Oral Treprostinil by Last Study Drug Dose and Reason for Discontinuation|In general, the dose of study drug was increased in 0.5 mg increments every 3 days, in the absence of dose-limiting drug-related AEs, to ensure the subject received the optimal clinical dose throughout the study.|Baseline and 16 weeks|Of 174 subjects randomized to receive oral treprostinil, 153 subjects who completed the study and 6 additional subjects who did not complete the study but discontinued the study due to adverse events were included in this analysis.||meters||Inter-Quartile Range|Median
723706|NCT00325442|Post-Hoc|Six Minute Walk Distance (6MWD) by Baseline 6MWD Quartile: Quartile 4 (398 - 450 Meters)||Baseline and 16 weeks|The study population was divided into quartiles by Baseline 6MWD. The subjects in this subgroup were in quartile 4 (398 - 450 meters).||meters||Inter-Quartile Range|Median
723707|NCT00325442|Post-Hoc|Six Minute Walk Distance (6MWD) by Baseline 6MWD Quartile: Quartile 3 (363 - 397 Meters)||Baseline and 16 weeks|The study population was divided into quartiles by Baseline 6MWD. The subjects in this subgroup were in quartile 3 (363 - 397 meters).||meters||Inter-Quartile Range|Median
723708|NCT00325442|Post-Hoc|Six Minute Walk Distance (6MWD) by Baseline 6MWD Quartile: Quartile 2 (303 - 362 Meters)||Baseline and 16 weeks|The study population was divided into quartiles by Baseline 6MWD. The subjects in this subgroup were in quartile 2 (303 - 362 meters).||meters||Inter-Quartile Range|Median
723709|NCT00325442|Post-Hoc|Six Minute Walk Distance (6MWD) by Baseline 6MWD Quartiles: Quartile 1 (126-302 Meters)||Baseline and 16 weeks|The study population was divided into quartiles by Baseline 6MWD. The subjects in this subgroup were in quartile 1 (126 - 302 meters).||meters||Inter-Quartile Range|Median
723710|NCT00325442|Secondary|Six Minute Walk Distance (6MWD)|"Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 4, correlates with the historical clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS).
The six minute walk test was to be conducted 3 to 6 hours after the previous dose of study drug."|Baseline and 4 weeks|||meters||Inter-Quartile Range|Median
723711|NCT00325442|Secondary|Six Minute Walk Distance (6MWD)|"Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 8, correlates with the historical clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS).
The six minute walk test was to be conducted 3 to 6 hours after the previous dose of study drug."|Baseline and 8 weeks|||meters||Inter-Quartile Range|Median
723712|NCT00325442|Secondary|Six Minute Walk Distance (6MWD)|"Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 12, correlates with the historical clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS).
The six minute walk test was to be conducted 3 to 6 hours after the previous dose of study drug."|Baseline and 12 weeks|||meters||Full Range|Median
723732|NCT00331552|Secondary|Time to Progression (Phase II)|Median time to progression. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions or new effusions.|Up to 2 years|||months||95% Confidence Interval|Median
723733|NCT00331552|Secondary|Treatment-related Toxicity (Phase I)|Count of phase I participants with treatment related toxicity.|Up to 24 weeks|||Participants|||Count of Participants
724909|NCT00348790|Secondary|Number of Months Patients Survive After Being Treatment on the Study.||From the date the first patient began treatment until the date the last patient became deceased.|||months||95% Confidence Interval|Median
723713|NCT00325442|Secondary|World Health Organization Functional Classification for PAH|"Class I: Patients with pulmonary hypertension but without resulting limitation of physical activity. Ordinary physical activity does not cause undue dyspnea or fatigue, chest pain, or near syncope.
Class II: Patients with pulmonary hypertension resulting in slight limitation of physical activity. These patients are comfortable at rest, but ordinary physical activity causes undue dyspnea or fatigue, chest pain or near syncope.
Class III: Patients with pulmonary hypertension resulting in marked limitation of physical activity. They are comfortable at rest. Ordinary activity causes undue dyspnea or fatigue, chest pain, or near syncope.
Class IV: Patients with pulmonary hypertension with inability to carry out any physical activity without symptoms. These patients manifest signs of right heart failure. Dyspnea and/or fatigue may be present even at rest. Discomfort is increased by any physical activity."|Week 16|||participants|||Number
723714|NCT00325442|Secondary|Dyspnea-Fatigue Index|The dyspnea-fatigue index has three components, each rated on a scale of 0 to 4, for the magnitude of the task that evokes dyspnea or fatigue, the magnitude of the pace (or effort) with which the task is performed and the associated functional impairment in general activities. The ratings for each component were added to form an aggregate score, which could range from 0, for the worst condition, to 12, for the best.|Baseline and 16 Weeks|Five subjects in the placebo arm and three subjects in the active arm did not have a Baseline dypsnea-fatigue index score.||units on a scale||Standard Deviation|Mean
723715|NCT00325442|Secondary|Clinical Worsening Assessment|"Definition of clinical worsening required one of the following:
Death (all causes excluding accident)
Transplantation or atrial septostomy
Clinical deterioration as defined by:
Hospitalization as a result of PAH, or
≥ 20% decrease in 6-minute walk distance from Baseline (or too ill to walk) and a decrease in WHO functional class And
Initiation of new PAH specific therapy (i.e., ERA, PDE5I, prostacyclin)."|Baseline and 16 Weeks|||participants|||Number
723716|NCT00325442|Secondary|Borg Dyspnea Score|The Borg dyspnea score is a 10-point scale rating the maximum level of dyspnea experienced during the 6-minute walk test. The Borg dyspnea score was assessed immediately following the 6-minute walk test. Scores ranged from 0 (for no shortness of breath) to 10 (for greatest shortness of breath ever experienced).|Baseline and 16 Weeks|One subject in the placebo arm did not have a Baseline Borg score value.||units on a scale||Standard Deviation|Mean
723717|NCT00325442|Primary|Six Minute Walk Distance (6MWD)|"Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 16, correlates with the historical clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS).
The six minute walk test was to be conducted 3 to 6 hours after the previous dose of study drug."|Baseline and 16 Weeks|||meters||Inter-Quartile Range|Median
723723|NCT00331422|Secondary|Quality of Life Score of Patients Receiving Neoadjuvant Chemotherapy|"Functional Assessment of Cancer Therapy-Ovarian (FACT-O) Questionnaire was used to assess the impact of treatment- and disease-related factors on the quality of life of patients with ovarian cancers undergoing chemotherapy. It is a 5 point scale (from worse to best: 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much responses). Physical well-being, social/family well-being, functional well-being, emotional well-being and additional concerns questions are asked.
Unable to evaluate; patients did not consistently complete the questionnaires."|Day 1, Week 12 (after 4th course) , Week 16 (4 weeks after last treatment)||||||
723724|NCT00331422|Secondary|Change in Thrombospondin-1 (TSP-1), p53, and Tumor Vessel Density|Unable to report due to incomplete (nonviable) or unsatisfactory tissue samples.|Week 18 (At surgery)||||||
723725|NCT00331422|Secondary|Change in Drug Resistance After Neoadjuvant Chemotherapy|As measured by extreme drug resistance assay - Unable to report due to tissue samples being incomplete or unsatisfactory to do laboratory testing.|Day 1 to Time to Surgery (Approximately Week 18)||||||
723726|NCT00331422|Secondary|Clinical Response Based on Serum Cancer Antigen 125 (CA-125) Concentration|Ca-125 serum results compared from baseline to after patient's last treatment. This is a tumor biomarker. A decrease in results indicates a clinical response.|From Baseline to up to 12 weeks (4 courses of therapy)|||Participants|||Number
723727|NCT00331422|Secondary|Patients' Overall Tumor Response as Measured by Response Evaluation Criteria in Solid Tumors (RECIST)|Best response recorded from start of treatment until after 4th cycle of treatment. Defined by the sum of Complete Responses (CR), Partial Responses (PR), and Stable Disease (SD) in patients neoadjuvant chemotherapy. CR=disappearance of all lesions, PR=>or=30% decrease in sumof all target lesins, Progressive Disease (PD) =>or =20% increase in sum of all target or any new lesions, SD=not CR, PR or PD.|Week 16 (4 weeks after 4th course)|||Participants|||Number
723728|NCT00331422|Primary|Number of Patients Who Underwent Optimal Cytoreduction After Chemotherapy|These patients had their tumor(s) removed by surgery after receiving 4 cycles of chemotherapy to determine their response.|Week 18 (After 4 cycles of chemotherapy)|Includes those patients that received 4 cycles of therapy before removal of cancerous tissue. Evaluation of overall response is not possible due to low number of patients and therefore could not obtain statistical significance.||Participants|||Number
723729|NCT00331552|Secondary|Comparison of Clinical Benefit Rate in 2 Subgroups--heavily Pre-treated (1 or More Regimens for Advanced Disease) vs Less Heavily Pre-treated (no Regimens for Advanced Disease) (Phase II)|Count of participants with a clinical benefit (i.e., complete response, partial response, and stable disease).|Up to 24 weeks|||Participants|||Count of Participants
723730|NCT00331552|Secondary|Overall Survival (Phase II)|Kaplan-Meier estimate assessed at 18 months|18 months|||survival probability||95% Confidence Interval|Number
723734|NCT00331552|Primary|Safety as Assessed by Grade 1, 2, 3, 4, Fatal Toxicity, Need for Dose Reduction, Treatment Interruption, or Treatment Discontinuation|Count of participants with grade 1, 2, 3, 4, fatal toxicity, need for dose reduction, treatment interruption, or treatment discontinuation|Periodically during study treatment, up to 24 weeks|||Participants|||Count of Participants
723735|NCT00331552|Primary|Efficacy as Assessed by the Overall Clinical Benefit Rate|Count of participants with a clinical benefit (i.e., complete response, partial response, and stable disease).|18 months|||Participants|||Count of Participants
723736|NCT00331552|Primary|Maximum Tolerated Dose and Optimal Tolerated Dose of Pegylated Liposomal Doxorubicin Hydrochloride (Doxil) When Given in Combination With Cyclophosphamide (Phase I)|The dose level in which 2 or more patients develop treatment-related toxicity of grade 3 or higher OR require a dose adjustment following the first course of treatment|Up to 24 weeks|||mg/m^2|||Number
723737|NCT00332839|Secondary|Changes in Proteinuria|The analysis for this outcome measure was not perfomed because the analyses could not be powered for efficacy due to low recruitment.|Baseline, 12 months||||||
723738|NCT00332839|Secondary|Changes in Cardiovascular Risk|The analysis for this outcome measure was not perfomed because the analyses could not be powered for efficacy due to low recruitment.|Baseline, 12 months||||||
723739|NCT00332839|Secondary|Number of Participants Who Experienced Adverse Events and Death|Participants were monitored for adverse events, serious adverse events and deaths thorughout the prospective and follow-up phases of the study.|12 months|The safety set, which included all randomized participants, comprised the analysis population.||Participants|||Number
723740|NCT00332839|Secondary|Evolution of Renal Function|The analysis for this outcome measure was not perfomed because the analyses could not be powered for efficacy due to low recruitment.|Baseline, 12 months||||||
723741|NCT00332839|Secondary|Occurrence of Treatment Failures|The analysis for this outcome measure was not perfomed because the analyses could not be powered for efficacy due to low recruitment.|12 months||||||
723742|NCT00332839|Secondary|Biopsy Proven Acute Rejection, Graft Loss, and Death|The analysis for this outcome measure was not perfomed because the analyses could not be powered for efficacy due to low recruitment.|12 months||||||
723743|NCT00332839|Primary|Renal Function|The analysis for this outcome measure was not perfomed because the analyses could not be powered for efficacy due to low recruitment.|12 months||||||
723744|NCT00333138|Secondary|Mean Trough Blood Concentrations of FTY720|For each patient, the arithmetic mean of the two FTY720 trough blood levels from month 3 and 6 was calculated. This was taken as the patient’s steady-state trough levels. Venous blood samples (3 mL) were collected before the dose in ethylenediaminetetraacetic acid (EDTA)-containing tubes at protocol-scheduled visits at months 3 and 6 in all patients.|Month 3 and 6|Pharmacokinetics population included all the patients who had sample collected and analysis was performed||ng/mL||Standard Deviation|Mean
723745|NCT00333138|Secondary|Time to Event Analysis: Kaplan Meier Estimates of Percentage of Relapse-free Patients|The Expanded Disability Status Scale (EDSS) is a scale for assessing disability in 8 functional systems (visual, brain stem, pyramidal, cerebellar, sensory, bowel & bladder, cerebral, other functions). An overall score ranging from 0 (normal) to 10 (death due to MS) is calculated. Disability progression was determined by the EDSS score based on the following criteria: One point increase from baseline in patients with baseline EDSS score from 0 to 5.0; or half a point increase in patients with baseline EDSS score of 5.5 or above. Percent of patients free of disability progression was calculated using the Kaplan-Meier method. The last observation was the last observation available for each patient which ranged from 1 to 2801 days|Month 6,12,60 and Last observation (up to 80 months in average)|"All randomized patients who received at least 1 dose of study drug during the core study were included in the ITT population. A patient at risk are those continuing in the study without an event before the specified timepoint The n denotes number of patients at risk."||percentage of participants||95% Confidence Interval|Number
723746|NCT00333138|Secondary|Change From Baseline in Volume of Total T2-weighted Lesions|Change in volume of total T2-weighted lesions by visit were summarized. Negative values indicate improvement (reduction in lesion volume) and positive values worsening (increase in lesion volume). The last observation was the last observation available for each patient which ranged from 1 to 2801 days.|Baseline to month 6, 12, 60 and Last observation (up to 80 months in average)|"All randomized patients who received at least 1 dose of study drug during the core study were included in the ITT population. The n in each category indicates participants with T2 information recorded at specific timepoints"||mm^3||Standard Deviation|Mean
723747|NCT00333138|Secondary|Volume of T2-weighted Lesions|Volume of total T2-weighted lesions by visit were summarized. The last observation was the last observation available for each patient which ranged from 1 to 2801 days|(Core) Month 6 and (Extension) 12, 60, last observation (up to 80 months in average)|"All randomized patients who received at least 1 dose of study drug during the core study were included in the ITT population. The n in each category indicates participants with T2 information recorded at specific timepoints"||mm^3||Standard Deviation|Mean
723748|NCT00333138|Secondary|Mean Number of New T2-weighted Lesions|New T2 lesions at a specific visit were assessed relative to the previous visit scan. The total number of lesions (Month 1 to end of study) is calculated as the sum of the number of lesions at Months 1 to 6, Month 12, Month 60 and last observation. The last observation was the last observation available for each patient which ranged from 1 to 2801 days|(Core) Month 6 and (Extension) 12, 60, last observation (up to 80 months in average)|"All randomized patients who received at least 1 dose of study drug during the core study were included in the ITT population. The n in each category indicates participants with T2 information recorded at specific timepoints"||GD enhanced T2 lesions||Standard Deviation|Mean
723749|NCT00333138|Secondary|Percentage of Patients Free of Gd-enhanced T1-weighted and New T2- Weighted Lesions by Visit|A patient was defined as free of lesions if s/he had zero lesions. The sum of all new T2-weighted lesions at Month 1 to last observation was zero (the sum is missing if one of the assessments was missing). New T2 lesions at a specific visit were assessed relative to the previous visit scan. Exception: new T2 lesions at Month 24 were assessed relative to Month 12. The last observation was the last observation available for each patient which ranged from 1 to 2801 days|Month 6 and 12, 60, last observation (up to 80 months in average)|"All randomized patients who received at least 1 dose of study drug during core study were included in the ITT population. The n number of patients with T2 and T1 information recorded at scan"||percentage of paticipants|||Number
723750|NCT00333138|Primary|Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at End of Study|Total number of post-baseline Gd-enhanced lesions is calculated as a sum of all Gd-enhanced lesions seen on post-baseline scans per visit. Real (not per slice) lesions are counted in this analysis. The last observation was the last observation available for each patient which ranged from 1 to 2801 days|Last observation (Up to 80 months in average)|All randomized patients who received at least 1 dose of study drug during the core study were included in the ITT population. Number of patients with T1 information recorded at scan were included in the analysis.||GD- enhanced T1 lesions||Standard Deviation|Mean
723751|NCT00333138|Primary|Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 60|Total number of post-baseline Gd-enhanced lesions is calculated as a sum of all Gd-enhanced lesions seen on post-baseline scans per visit. Real (not per slice) lesions are counted in this analysis.|Month 60 (extension)|All randomized patients who received at least 1 dose of study drug during the core study were included in the ITT population. Number of patients with T1 information recorded at scan were included in the analysis.||GD- enhanced T1 lesions||Standard Deviation|Mean
723752|NCT00333138|Primary|Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 12|Total number of post-baseline Gd-enhanced lesions is calculated as a sum of all Gd-enhanced lesions seen on post-baseline scans per visit. Real (not per slice) lesions are counted in this analysis.|Month 12 (extension)|All randomized patients who received at least 1 dose of study drug during the core study were included in the ITT population. Number of patients with T1 information recorded at scan were included in the analysis.||GD- enhanced T1 lesions||Standard Deviation|Mean
723753|NCT00333138|Secondary|Percentage of Participants Free of T1-weighted Lesions|A patient was defined as free of lesions if s/he had zero lesions. The last observation was the last observation available for each patient which ranged from 1 to 2801 days|Baseline, Months 6 (core), 12, 60 and Last Observation (up to 80 months in average)|"All randomized patients who received at least 1 dose of study drug during the core study were included in the ITT population. Number of patients with T1 information recorded at scan were included in the analysis. The n in each category indicates number of patients wih information recorded at scan"||percentage of participants|||Number
723754|NCT00333138|Primary|Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 6 (Core)|Total number of post-baseline Gd-enhanced lesions is calculated as a sum of all Gd-enhanced lesions seen on post-baseline scans per visit. Real (not per slice) lesions are counted in this analysis.|Month 6 (Core)|All randomized patients who received at least 1 dose of study drug during the core study were included in the ITT population. Number of patients with T1 information recorded at scan were included in the analysis.||GD- enhanced T1 lesions||Standard Deviation|Mean
723755|NCT00333229|Secondary|Development of Metastases as Assessed by X-ray, CT, or MRI During 24 Months and During 60 Months||2 years||||||
723756|NCT00333229|Secondary|Pathologic Fractures During 24 Month||2 years||||||
723757|NCT00333229|Secondary|Course of Biochemical Markers of Bone Turn Over (FSH, Estradiol (E2), Osteocalcin, PINP, Procollagene-I-peptid, Deoxypyridinoline in Serum)||2 years||||||
723758|NCT00333229|Secondary|Bone Mineral Density (BMD) Measured by QUS at os Calcis and Phalanges After 24 Months||2 years||||||
723759|NCT00333229|Primary|Change in Bone Mineral Density (BMD) Measured by DXA at Lumbar Spine (L2-L4) Between Baseline and 24 Months.||24 months|Analysis was not completed as study was not adequately powered due to premature study termination.|||||
723760|NCT00333359|Secondary|Mean Change From Baseline at Weeks 24 and 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Individual Item: RLS Affected Productivity|The WPAI:SHP estimates work productivity and social activities lost over the past week due to RLS symptoms. Change is calculated as the observed value at Week 52 minus the observed value at baseline. Productivity affected while working is estimated on a 0 (no effect) to 10 scale (completely preventing productivity).|Baseline and Weeks 24 and 52|Safety Population: all participants who received one dose or any part of one dose of GEn. Results include only observed cases and do not include early termination values; as such the number of participants analyzed at each week differs from the number of participants in the Baseline characteristics summary.||points on a scale||Standard Deviation|Mean
723761|NCT00333359|Secondary|Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Individual Items: Hours of Work Missed Due to RLS, Hours of Work Missed Due to Other Reason, and Hours Actually Worked|The WPAI:SHP estimates work productivity and social activities lost over the past week due to RLS symptoms. Change is calculated as the observed value at Week 24/52 minus the observed value at baseline. Absenteeism is recorded as the number of hours missed from work. W, Week; hr, hour.|Baseline and Weeks 24 and 52|Safety Population. Results include only observed cases and do not include early termination values; as such, the number of participants analyzed at each week differs from the number of participants in the Baseline Characteristics summary.||hours||Standard Deviation|Mean
723762|NCT00333359|Secondary|Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Summary Scores|The WPAI:SHP estimates work productivity and social activities lost over the past week due to RLS symptoms. Each summary score is expressed as a percentage and ranges from 0 to 100, with higher scores indicating more work missed; a negative change from baseline indicates less work missed. Change = the observed value at the current visit minus the observed value at Week 0. Change is calculated only for participants who had a value at both the current visit and at Week 0.|Baseline and Weeks 24 and 52|Safety Population. Results include only observed cases and do not include early termination values; as such, the number of participants analyzed at each week differs from the number of participants in the Baseline Characteristics summary.||percent change||Standard Deviation|Mean
723763|NCT00333359|Secondary|Overall Quality of Life (QoL) Impact Score of the RLS Quality of Life Questionnaire at Weeks 24 and 52|The RLS QoL is an 18-item scale assessing the impact of RLS on daily life, emotional well-being, social and work life. Responses range from 1 (not at all/never) to 5 (a lot/all of the time). Ten items contribute to a single summary score, the Overall Life Impact, which is standardized to range from 0-100, with lower scores representing better QoL.|Weeks 24 and 52|Safety Population. Results include only observed cases and do not include early termination values; as such, the number of participants analyzed at each week differs from the number of participants in the Baseline Characteristics summary.||points on a scale||Standard Deviation|Mean
723812|NCT00333801|Secondary|Employment Outcomes (Hours Competitively Employed)|hours employed in a competitive (not set-aside) job|one year|All randomized participants (intent-to-treat)||hours||Standard Deviation|Mean
723764|NCT00333359|Secondary|Median Time to Onset of the First RLS Symptom Using the RLS Symptom Record at Weeks 24 and 52|The 24-Hour RLS Record is a diary in which participants report the presence and severity of RLS symptoms for a 24-hour period, in 30-min increments, beginning at 8AM on the day prior to the visit.|Weeks 24 and 52|Safety Population. Results include only observed cases and do not include early termination values; as such, the number of participants analyzed at each week differs from the number of participants in the Baseline Characteristics summary.||hours||Full Range|Median
723765|NCT00333359|Secondary|Number of Participants With no Reported RLS Symptoms During Each of the 4-hour Periods From the 24-hour RLS Record at Week 52 Using OC Data|In the 24-Hour RLS Record (diary), participants report the presence and severity of RLS symptoms (none, mild, moderate, or severe) for a 24-hour period, in 30-minute increments. The period was divided into 7 four-hour intervals (8 AM to 12PM, 12 to 4PM, 4 to 8PM, 6 to 10PM, 8 to 12 Midnight, Midnight to 4AM, 4 to 8AM).|Week 52|Safety Population. Results at Week 52 include only Week 52 observed cases and do not include early termination values; as such, the number of participants with data at each time point differs from the number of participants in the Baseline Characteristics summary.||participants|||Number
723766|NCT00333359|Secondary|Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC|"The Participant-rated CGI-I is a self-reported measure completed by the participant who rates the change from the start of the study in the severity of their illness using a seven-point rating scale, with a score of 1 being very much improved, 2 being much improved, 3 being minimally improved, 4 being no change, 5 being minimally worse, 6 being much worse, and 7 being very much worse compared to the start of the study."|Weeks 0, 1, and 52|Safety Population. Results at each week include only observed cases and do not include early termination values; as such, the number of participants analyzed differs from the number of participants in the Baseline Characteristics summary.||participants|||Number
723767|NCT00333359|Secondary|Number of Participants Classified as Responders to Treatment on the Participant-rated CGI-I at Each Visit Using OC|"The Participant-rated CGI-I is a self-reported measure completed by the participant, who rates the change from the start of the study in the severity of their illness using a seven-point rating scale, with a score of 1 being very much improved and a score of 7 being very much worse. Responders on the Participant-rated CGI-I are defined as those with a score of 1 or 2, corresponding to very much improved and improved, respectively."|Weeks 0, 1, 4, 12, 24, 36, and 52|Safety Population. Results at each week include only observed cases and do not include early termination values; as such, the number of participants analyzed at each week differs from the number of participants in the Baseline Characteristics summary.||participants|||Number
723768|NCT00333359|Secondary|Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC|"The CGI-I is a widely used tool designed to allow clinicians to rate the severity of illness and the change over time based on a seven-point rating scale, with a score of 1 being very much improved, 2 being much improved, 3 being minimally improved, 4 being no change, 5 being minimally worse, 6 being much worse, and 7 being very much worse compared to the start of the study."|Weeks 0, 1, and 52|Safety Population. Results at each week include only observed cases and do not include early termination values; as such, the number of participants analyzed differs from the number of participants in the Baseline Characteristics summary.||participants|||Number
723769|NCT00333359|Secondary|Change From Baseline in the IRLS Rating Scale Score at Each Visit Using OC|The IRLS rating scale is a measure of RLS disease severity. The score reflects participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. Also, items are included that assess the impact of symptoms on participants' mood, daily life, and activities. The total score on the IRLS ranges from 0 to 40, with higher values representing more severe RLS symptoms. Change from baseline was calculated as the value at each visit minus the baseline value. Change scores with higher values represent greater improvement in RLS symptoms.|Weeks 0, 1, 4, 12, 24, and 36|Safety Population. Results at each week include only observed cases and do not include early termination values; as such, the number of participants analyzed differs from the number of participants in the Baseline Characteristics summary.||points on a scale||Standard Deviation|Mean
723770|NCT00333359|Primary|Number of Participants Classified as Responders to Treatment on the Investigator-rated Clinical Global Impressions of Improvement (CGI-I) at Each Visit Using OC|"The CGI-I is a widely used tool designed to allow clinicians to rate the severity of illness and the change over time based on a seven-point rating scale, with a score of 1 being very much improved and a score of 7 being very much worse compared to the start of the study. Responders on the CGI-I are defined as those with a score of 1 or 2, corresponding to very much improved or improved, respectively."|Weeks 0, 1, 4, 12, 24, 36, and 52|Safety Population. Results at each week include only observed cases and do not include early termination values; as such, the number of participants analyzed differs from the number of participants in the Baseline Characteristics summary.||participants|||Number
723771|NCT00333359|Primary|Change From Baseline in the International Restless Legs Syndrome Rating Scale (IRLS) at Week 52 Using Observed Case (OC)|The IRLS rating scale is a measure of RLS disease severity. The score reflects participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. Also, items are included that assess the impact of symptoms on participants' mood, daily life, and activities. The total score on the IRLS ranges from 0 to 40, with higher values representing more severe RLS symptoms. Change from baseline was calculated as the Week 52 value minus the baseline value. Change scores with higher value represents greater improvement in RLS symptoms.|Baseline and Week 52|Safety Population: all participants who received one dose or any part of one dose of GEn. Week 52 (end of treatment) results included only Week 52 observed cases and do not include early termination values; as such, the number of participants analyzed differs from the number of participants in the Baseline Characteristics summary.||points on a scale||Standard Deviation|Mean
723772|NCT00333437|Secondary|Mean Change in Diffusion Capacity of the Lung for Carbon Monoxide (DLCO)|DLCO was measured before beginning and after completion of study therapy|12 months|||Liters||Standard Deviation|Mean
723773|NCT00333437|Secondary|Mean Change in Six Minute Walk Distance|Comparison of 6-minute walk distance before beginning and after completing study therapy|12 months|||Feet||Standard Deviation|Mean
723774|NCT00333437|Secondary|Change in Shortness of Breath (Self-reported)|Participants reported frequency of shortness of breath experienced with exertion|Baseline, 12 months|||participants|||Number
723775|NCT00333437|Secondary|Mean Change in Bronchoalveolar Lavage (BAL) Components (Neutrophils, Eosinophils)|BAL samples were colleected from the affected lobe (as determined by lung CT scans) before beginning and after completing study therapy.|Baseline, 12 months|||Cells/uL||Standard Deviation|Mean
723776|NCT00333437|Primary|Mean Change From Baseline in Forced Vital Capacity (FVC)|compare pre- and post-therapy FVC (post- minus pre-). Forced vital capacity (FVC) is the volume of air (liters) that can forcibly be blown out after full inspiration.|Baseline, 12 months|||Liters||Standard Deviation|Mean
723777|NCT00333619|Primary|Sleep Efficiency|Average sleep efficiency calculated from 7 days of actigraphy. Sleep efficiency for each night is calculated as the number of hours asleep divided by the number of hours in bed.|3-month follow-up|||percentage of time asleep while in bed||Standard Deviation|Mean
723778|NCT00333619|Primary|Pittsburgh Sleep Quality Index|The PSQI is a 18-item questionnaire that measures subjective sleep quality and sleep disturbances (total score ranging from 0 – 21; score > 8 indicates poor sleep quality).|3-month follow-up|||units on a scale; 0-21||Standard Deviation|Mean
723779|NCT00333710|Primary|Hepatitis C Virus Knowledge Questionnaire|This is a 62-item measure which assesses knowledge of the hepatitis C Virus. Range is 0 to 62. Higher scores reflect greater hepatitis C knowledge|pre-treatment, post-treatment|||units on a scale||Standard Deviation|Mean
723780|NCT00333762|Primary|Time to Complete Trial Wheelchair Course|Time to complete the course was recorded. The indoor course was set up in the research laboratory to include a straight path and 90 degree turns that included obstacles such as a cardboard box, a large orange cone, and a desk chair. The location of these obstacles were randomly placed in order to test whether or not the SPAM or SWCS was able to detect objects.|Two years|No data was collected.|||||
723781|NCT00333775|Secondary|Overall Survival|Overall survival was defined as the time from randomization to death from any cause.|Baseline to the 15 Sep 2008 cut-off date (up to 2 years, 6 months)|Intent-to-treat population: All randomized participants, regardless of whether they received study drug or not.||Months||95% Confidence Interval|Median
723782|NCT00333775|Secondary|Time to Treatment Failure|Time to treatment failure was defined as time from randomization to the date of disease progression, death, or withdrawal of treatment due to an adverse event, withdrawal of informed consent, insufficient therapeutic response, refusal of treatment/failure to co-operate, or failure to return, whichever occurred first.|Baseline to the 15 September 2008 cut-off date (up to 2 years, 6 months)|Intent-to-treat population: All randomized participants, regardless of whether they received study drug or not.||months||95% Confidence Interval|Median
723783|NCT00333775|Secondary|Duration of Response|Duration of response was defined as the time from the first documented complete response or partial response to disease progression or death. A complete response was defined as the disappearance of all target lesions or the disappearance of all non-target lesions and normalization of tumor marker level. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Responses were evaluated using the Response Evaluation Criteria in Solid Tumors.|Baseline to the 15 September 2008 cut-off date (up to 2 years, 6 months)|Intent-to-treat population: All randomized participants, regardless of whether they received study drug or not. Only participants with measurable disease at Baseline who had a complete response or a partial response were included in the analysis.||Months||95% Confidence Interval|Median
723784|NCT00333775|Secondary|Percentage of Participants With a Complete Response or a Partial Response|Responses were evaluated using the Response Evaluation Criteria in Solid Tumors. A complete response was defined as the disappearance of all target lesions or the disappearance of all non-target lesions and normalization of tumor marker level. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter.|Baseline to the 15 Sep 2008 cut-off date (up to 2 years, 6 months)|Intent-to-treat population: All randomized participants, regardless of whether they received study drug or not. Only participants with measurable disease at Baseline were included in the analysis.||Percentage of participants||95% Confidence Interval|Number
723785|NCT00333775|Primary|Progression-free Survival|Progression-free survival was evaluated using Response Evaluation Criteria In Solid Tumors (RECIST 1.0). Progression-free survival was defined as the time from randomization to the time of the first documented disease progression or death, whichever occurred first. Disease progression was defined as ≥ 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions, or appearance of new lesion(s).|Baseline to the 15 Sep 2008 cut-off date (up to 2 years, 6 months)|Intent-to-treat population: All randomized participants, regardless of whether they received study drug or not.||Months||95% Confidence Interval|Median
723786|NCT00333788|Secondary|Occurrence of at Least 1 Concurrent Medical Procedure During the Overall Period|"Overall period corresponds to both treatment and follow-up periods in C87046.
Results are presented as the number of subjects who had at least 1 concurrent medical procedure during the overall period."|Maximum 164 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.||participants|||Number
723787|NCT00333788|Secondary|Occurrence of at Least 1 Concurrent Medical Procedure During the Follow-Up Period|"Follow-up period start the day after the last injection up to 84 days after last injection.
Results are presented as the number of subjects who had at least 1 concurrent medical procedure during the follow-up period."|Maximum 12 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.||participants|||Number
723788|NCT00333788|Secondary|Occurrence of at Least 1 Concurrent Medical Procedure During the Treatment Period.|"The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit.
Results are presented as the number of subjects who had at least 1 concurrent medical procedure during the treatment period."|Maximum 152 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.||participants|||Number
723813|NCT00333801|Secondary|Employment Outcomes (Days Competitively Employed|Number of days employed in a competitive job (not set-aside job)|one year|All randomized participants (intent-to-treat)||days||Standard Deviation|Mean
723789|NCT00333788|Secondary|Occurrence of at Least 1 General Concomitant Medication During the Overall Period|"Overall period corresponds to both treatment and follow-up periods in C87046.
Results are presented as the number of subjects who used at least 1 concomitant medication during the overall period."|Maximum 164 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.||participants|||Number
723790|NCT00333788|Secondary|Occurrence of at Least 1 General Concomitant Medication During the Follow-Up Period|"Follow-up period start the day after the last injection up to 84 days after last injection.
Results are presented as the number of subjects who used at least 1 concomitant medication during the follow-up period."|Maximum 12 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.||participants|||Number
723791|NCT00333788|Secondary|Occurrence of at Least 1 General Concomitant Medication During the Treatment Period|"The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit.
Results are presented as the number of subjects who used at least 1 concomitant medication during the treatment period."|Maximum 152 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.||participants|||Number
723792|NCT00333788|Secondary|Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn’s Disease During the Overall Period|"Overall period corresponds to both treatment and follow-up periods in C87046.
Medication categories are anti tumor necrosis factor (anti-TNFs), immunosuppressants, corticosteroids, 5 aminosalicylic acid (5-ASA) and antibiotics.
Results are presented as the percentage of subjects with at least 1 concomitant medication potentially influencing Crohn's disease during the overall period."|Maximum 164 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.||percentage of participants|||Number
723793|NCT00333788|Secondary|Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn’s Disease During the Follow-Up Period|"Follow-up period start the day after the last injection up to 84 days after last injection.
Medication categories are anti tumor necrosis factor (anti-TNFs), immunosuppressants, corticosteroids, 5 aminosalicylic acid (5-ASA) and antibiotics.
Results are presented as the percentage of subjects with at least 1 concomitant medication potentially influencing Crohn's disease during the follow-up period."|Maximum 12 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.||percentage of participants|||Number
723794|NCT00333788|Secondary|Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn’s Disease During the Treatment Period|"The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit.
Medication categories are anti tumor necrosis factor (anti-TNFs), immunosuppressants, corticosteroids, 5 aminosalicylic acid (5-ASA) and antibiotics.
Results are presented as the percentage of subjects with at least 1 concomitant medication potentially influencing Crohn's disease during the treatment period."|Maximum 152 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.||percentage of participants|||Number
723795|NCT00333788|Secondary|Occurrence of at Least 1 Emergency Room Visit During the Overall Period|"Overall period corresponds to both treatment and follow-up periods in C87046.
Results are presented as the percentage of subjects with at least 1 emergency room visit during the overall period."|Maximum 164 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.||percentage of participants|||Number
723796|NCT00333788|Secondary|Occurrence of at Least 1 Emergency Room Visit During the Follow-Up Period|"Follow-up period starts the day after the last injection up to 84 days after last injection.
Results are presented as the percentage of subjects with at least 1 emergency room visit during the follow-up period."|Maximum 12 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.||percentage of participants|||Number
723797|NCT00333788|Secondary|Occurrence of at Least 1 Emergency Room Visit During the Treatment Period|"The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit.
Results are presented as the percentage of subjects with at least 1 emergency room visit during the treatment period."|Maximum 152 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.||percentage of participants|||Number
723798|NCT00333788|Secondary|Length of Hospital Stays During the Overall Period|Overall period corresponds to both treatment and follow-up periods in C87046.|Maximum 164 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.||days||Standard Deviation|Mean
723799|NCT00333788|Secondary|Length of Hospital Stays During the Follow-Up Period|Follow-up period starts the day after the last injection up to 84 days after last injection.|Maximum 12 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.||days||Standard Deviation|Mean
723800|NCT00333788|Secondary|Length of Hospital Stays During the Treatment Period|The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit.|Maximum 152 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.||days||Standard Deviation|Mean
723801|NCT00333788|Secondary|Occurrence of at Least 1 Hospital Stay During the During the Overall Period|"Overall period corresponds to both treatment and follow-up periods in C87046.
Results are presented as the percentage of subjects with at least 1 hospital stay during the overall period."|Maximum 164 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.||percentage of participants|||Number
723802|NCT00333788|Secondary|Occurrence of at Least 1 Hospital Stay During the Follow-Up Period|"Follow-up period starts the day after the last injection up to 84 days after last injection.
Results are presented as the percentage of subjects with at least 1 hospital stay during the follow-up period."|Maximum 12 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.||percentage of participants|||Number
723803|NCT00333788|Secondary|Occurrence of at Least 1 Hospital Stay During the Treatment Period|"The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit.
Results are presented as the percentage of subjects with at least 1 hospital stay during the treatment period."|Maximum 152 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.||percentage of participants|||Number
723804|NCT00333788|Secondary|Time to Loss of Response After Baseline of Study C87042 (NCT00308581) on Subjects Who Were in Clinical Response at Baseline of This Study|"Clinical response at Baseline of this study of at least a 100 point decrease from Baseline of study C87042 in Crohn's Disease Activity Index (CDAI)
Loss of response = both a CDAI score >150 points and a minimum increase in CDAI of 70 points versus Baseline (Week 26 of study C87042) as confirmed at 2 consecutive visits. Subjects losing response will be considered as having the event on the date of the first visit where response was lost. Subjects who discontinued the study without having lost response will be censored on the date of discontinuation (i.e. date of last visit performed)."|Maximum 154 weeks|Of the 233 subjects in the study 153 are in the Modified Intent to Treat (MITT) population and are responders at Baseline of this study and are in this analysis. The MITT population includes subjects that are in the ITT population that were correctly randomized at Week 6 of study C87042 (NCT00308581).||days||Full Range|Median
723805|NCT00333788|Secondary|Change From Baseline of Study C87042 (NCT00308581) in Crohn’s Disease Activity Index (CDAI) at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals]|CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Baseline of study C87042 (NCT00308581) and Last Visit [Up to the maximum study duration observed in the study (Week 154) or the Withdrawal Visit for Premature Withdrawals]|Of the 233 subjects in the study, 215 are in the Intent to Treat (ITT) population with Crohn's Disease Activity Index (CDAI) scores at Baseline and Last/Withdrawal visits and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.||score on a scale||Standard Deviation|Mean
723806|NCT00333788|Secondary|Remission at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals]|"Remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤ 150 points
CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
Results are presented as the percentage of subjects in remission at Last visit."|Last Visit [Up to the maximum study duration observed in the study (Week 154) or the Withdrawal Visit for Premature Withdrawals]|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.||percentage of participants|||Number
723807|NCT00333788|Secondary|Clinical Response at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals]|"Clinical response is defined as at least a 100 point decrease from Baseline of study C87042 (NCT00308581) in Crohn’s Disease Activity Index (CDAI).
CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
Results are presented as the percentage of subjects achieving clinical response at Last visit."|Baseline of study C87042 (NCT00308581) and Last Visit [Up to the maximum study duration observed in the study (Week 154) or the Withdrawal Visit for Premature Withdrawals]|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.||percentage of participants|||Number
723808|NCT00333788|Secondary|Maintenance of Response at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals] Among the Subjects in Clinical Response at Baseline of This Study (Week 26 of Study C87042).|"Clinical response is defined as at least a 100 point decrease from Baseline of study C87042 (NCT00308581) in Crohn's Disease Activity Index (CDAI).
Subjects maintained their clinical response at Last Visit if they did not meet criteria for loss of response [CDAI score >150 points and a minimum increase in CDAI of 70 points versus Baseline of study C87042 (NCT00308581)] at 2 consecutive visits.
A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
Results are presented as the percentage of subjects maintaining response at Last visit."|Baseline (corresponding to Week 26 of study C87042 (NCT00308581) and Last Visit [Up to the maximum study duration observed in the study (Week 154) or the Withdrawal Visit for Premature Withdrawals]|Of the 233 subjects in the study, 166 are in the Intent to Treat (ITT) population and were in clinical response at Baseline of this study, and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.||percentage of participants|||Number
723809|NCT00333788|Primary|Occurrence of at Least One Study-emergent Adverse Event During the Study (Maximum 164 Weeks)|"Study-emergent adverse events are defined as treatment-emergent adverse events with an onset date on or after the first study drug administration date of this study but not later than 12 weeks (84 days) after last injection.
Results are presented as the percentage of subjects with at least one treatment-emergent adverse event during this study."|Maximum 164 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.||percentage of participants|||Number
723810|NCT00333801|Secondary|Employment Outcomes (Total Gross Income From All Sources|total gross income from all sources of work including noncompetitive and competitive jobs|one year|All randomized participants (intent-to-treat)||US dollars||Standard Deviation|Mean
723811|NCT00333801|Secondary|Employment Outcomes (Gross Income Competitive)|total gross income (US dollars) from all competitive wages, salary, commissions|one year|All randomized participants (intent-to-treat)||US dollars||Standard Deviation|Mean
723815|NCT00333801|Secondary|PTSD, Depression, Disability Outcomes|Clinician Administered PTSD Scale for DSM-IV (CAPS) score range 0-136 with higher=more severe; Quick Inventory of Depression Scale - Clinician-rated (QIDS-CR) score range 0-27 with higher=more severe; Clinical Global Impression-Severity (CGI-S) score range 1-7 with higher=more severe; Davidson Trauma Scale (DTS) score range 0-136 with higher=more severe; and World Health Organization Disability Assessment Scale (WHODAS-II) 36-items rated on 5-point scale, from 1 (no difficulty) to 5 (extreme difficulty/cannot do) in 6 domains of life; domain scores are transformed from the total raw score (sum of items) of each domain according to the following formula: Transformed score=[(actual raw score – lowest possible raw score) / (possible raw score range)] x 100.|one-year|All randomized participants (intent-to-treat)||units on a scale||Standard Deviation|Mean
723816|NCT00333801|Primary|Obtain Competitive Employment|The primary outcome: competitive employment (Yes or No). Competitive employment was defined as a job for regular wages in a setting that was not set aside, or sheltered, that is, the job could be held by people without a mental illness or disability and was not a set-aside job in the VRP. Day labor (babysitting, manual labor by the day, drill, temporary work for family or friends) was not considered competitive employment.|1 calendar year|All randomized participants were included in the analysis (intent-to-treat)||participants|||Number
723817|NCT00333814|Other Pre-specified|Percentage of Patients With at Least a 10-Point Improvement in the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25)Score|Percentage of patients with at least a 10-Point Improvement in the NEI-VFQ-25 over-all composite score at Week 8 from Baseline. The NEI-VFQ-25 consists of 25 vision-targeted questions plus one general health question resulting in a score of 0-100 (100 represents best functionality).|Week 8|Intent to Treat||Percentage of Patients|||Number
723818|NCT00333814|Other Pre-specified|Percentage of Patients With at Least a 15-Letter Improvement in Best Corrected Visual Acuity (BCVA)|Percentage of Patients with at least a 15-letter improvement in BCVA at Week 8 from Baseline. BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). An improvement in the number of letters read means that the vision has improved.|Week 8|Intent to Treat||Percentage of Patients|||Number
723819|NCT00333814|Primary|Percentage of Patients With Vitreous Haze (Ocular Inflammation) Score of Zero|Percentage of patients with Vitreous Haze Score of Zero at Week 8. Score is based on standardized scale of 0 to +4 where 0 equals no inflammation and +4 equals optic nerve head not visible (severe).|Week 8|Intent to Treat||Percentage of Patients|||Number
723820|NCT00333840|Secondary|Percentage of Participants With Major Molecular Response (Second-line Treatment)|Major Molecular Response was determined using a quantitative polymerase chain reaction (PCR) laboratory test and was defined as BCR-ABL protein transcripts of ≤ 0.1% according to the international scale.|12,24,36,48,60,72,84,96,108,120,132 and 144 months|Intent-to-treat population included all randomized participants. No participants in the imatinib to IFN-a + Ara-C arm were available for testing.||Percentage of participants|||Number
723821|NCT00333840|Secondary|Percentage of Participants With Major Molecular Response (First-line Treatment)|Major Molecular Response was determined using a quantitative polymerase chain reaction (PCR) laboratory test and was defined as BCR-ABL protein transcripts of ≤ 0.1% according to the international scale.|12,24,36,48,60,72,84,96,108,120,132 and 144 months|Intent-to-treat population included all randomized participants.||Percentage of participants|||Number
723822|NCT00333840|Secondary|Number of Participants With Serious Adverse Events as a Measure of Safety (Second-line Treatment)|A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant|144 months|Safety Population included all randomized participants who received study drug.||Participants|||Number
723823|NCT00333840|Secondary|Number of Participants With Serious Adverse Events as a Measure of Safety (First-line Treatment)|A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant|144 months|Safety Population included all randomized participants who received study drug.||Participants|||Number
723824|NCT00333840|Secondary|Percentage of Participants With Best Cytogenetic Response (Second-line Treatment)|"Bone marrow aspirate was performed to evaluate cytogenetic results (percentage of Ph chromosome (Ph+) containing metaphases) and the amount of blasts and promyelocytes in bone marrow to establish cytogenetic response.
Major Cytogenetic Response= Complete Response or Partial Response. Complete Cytogenetic Response= 0 % of Ph+ metaphases (out of 20 metaphases). Partial Cytogenetic Response= > 0 and ≤ 35 % Ph+ metaphases (out of 20 metaphases). The percentage of participants with cytogenetic response in each category was calculated."|144 months|Intent-to-treat participants included all randomized participants.||Percentage of participants|||Number
723825|NCT00333840|Secondary|Percentage of Participants With Best Cytogenetic Response (First-line Treatment)|"Bone marrow aspirate was performed to evaluate cytogenetic results (percentage of Philadelphia chromosome positive (Ph+) metaphases) and amount of blasts and promyelocytes in bone marrow to establish cytogenetic response.
Major Cytogenetic Response= Complete Response or Partial Response. Complete Cytogenetic Response= 0 % of Ph+ metaphases (out of 20 metaphases). Partial Cytogenetic Response= > 0 and ≤ 35 % of Ph+ metaphases (out of 20 metaphases). The percentage of participants with cytogenetic response in each category was calculated."|144 months|Intent-to-treat participants included all randomized participants.||Percentage of participants|||Number
723865|NCT00334282|Secondary|Duration of Response|Duration of response is defined as the time from first observation of response until progression of disease or death.|Time from response until progression (up to 2 years)|ITT Population. Only results for pazopanib are given because there were not enough placebo responders.||weeks||95% Confidence Interval|Median
723887|NCT00334802|Primary|Tumor Response|"Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve (respond), stay the same (stable), or worsen (progression) during treatment. Responders are patients with complete response or partial response."|baseline to measured progressive disease|||participants|||Number
723826|NCT00333840|Secondary|Kaplan Meier Estimates of Time to Progression to Accelerated Phase (AP) or Blast Crisis (BC) (All Randomized Participants)|Time to progression to AP/BC is defined as the time between randomization and either of the following events on treatment: death (due to CML when reported as primary reason for discontinuation of treatment) or progression to Accelerated Phase or Blast Crisis and is censored at last examination date for patients without event. No data after discontinuation of study treatment was included. The Kaplan Meier estimates of the percentage of participants with survival without progression to AP/BC at the given time point was calculated. This outcome was measured in all randomized patients, regardless of whether crossover occurred, i.e., events that occurred in patients, who had crossed over, were attributed following crossover to the original randomized treatment.|12,24,36,48,60,72,84,96,108,120,132 and 144 months|Intent-to-treat population included all randomized participants. n = number of participants at risk at the beginning of the specific time interval||Percentage of participants|||Number
723827|NCT00333840|Secondary|Percentage of Participants With Event Free Survival Events (All Randomized Participants)|"Event-free survival is defined as the time between randomization and the earliest of any of the following events on treatment:
progression to Accelerated Phase (AP) or Blast Crisis (BC)
loss of Complete Hematological Response (CHR)
loss of Major Cytogenic Response (MCyR) confirmed
loss of Major Cytogenic Response (MCyR) unconfirmed
increase in white blood cell count (WBC) if approved by the Study Management Committee (SMC)
death (due to any cause when reported as primary reason for discontinuation of treatment).
The percentage of participants with Event Free Survival events in each category was calculated. This outcome was measured in all randomized patients, regardless of whether crossover occurred, i.e., events that occurred in patients, who had crossed over, were attributed following crossover to the original randomized treatment."|144 months|Intent-to-treat population included all randomized participants.||Percentage of participants|||Number
723828|NCT00333840|Secondary|Kaplan Meier Estimates of Event Free Survival (All Randomized Participants)|"Event-free survival is defined as the time between randomization and the earliest of any of the following events on treatment:
progression to Accelerated Phase (AP) or Blast Crisis (BC)
loss of Complete Hematological Response (CHR)
loss of Major Cytogenetic Response (MCyR) confirmed
loss of Major Cytogenetic Response (MCyR) unconfirmed
increase in white blood cell count (WBC) if approved by the Study Management Committee (SMC)
death (due to any cause when reported as primary reason for discontinuation of treatment).
Kaplan Meier estimates of the percentage of participants with Event Free Survival at the given time point was calculated. This outcome was measured in all randomized patients, regardless of whether crossover occurred, i.e., events that occurred in patients, who had crossed over, were attributed following crossover to the original randomized treatment."|12,24,36,48,60,72,84,96,108,120,132 and 144 months|Intent-to-treat population included all randomized participants. n = number of participants at risk at the beginning of the specific time interval||Percentage of participants|||Number
723829|NCT00333840|Primary|Kaplan-Meier Estimates of Overall Survival (All Randomized Participants)|Overall survival was defined as the time between date of randomization and death due to any cause. The time was censored at last examination date for patients who were still being treated and at date of last contact for patients who discontinued treatment. Kaplan-Meier estimates of the percentage of participants at each time point was calculated. This outcome was measured in all randomized patients, regardless of whether crossover occurred, i.e., events that occurred in patients, who had crossed over, were attributed following crossover to the original randomized treatment.|12,24,36,48,60,72,84,96,108,120,132 and 144 months|Intent-to-treat population included all randomized participants. n = number of participants at risk at the beginning of the specific time interval||Percentage of participants|||Number
723830|NCT00333866|Secondary|Total Daily Acetaminophen Dose|Acetaminophen (up to 4 gram/day as needed for pain relief) was an allowable concomitant medication as a rescue therapy. The total daily acetaminophen dose taken during double-blind treatment was calculated for each participant as: (total acetaminophen dose during the study) divided by (total number of study days).|Week 14|FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||mg/day||Standard Error|Least Squares Mean
723831|NCT00333866|Secondary|Change From Baseline in Pain Visual Analogue Scale (VAS) Scores at Week 14|Pain visual analog scale (VAS): Participants assessed the severity of their pain using a 100 mm visual analog scale (VAS). The scale ranged from 0 (no pain) to 100 (worst possible pain), measurement on a scale corresponds to the magnitude of their pain.|Baseline, Week 14|FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||mm||Standard Error|Least Squares Mean
723832|NCT00333866|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Week 14|HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.|Baseline, Week 14|FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||Units on a scale||Standard Error|Least Squares Mean
723833|NCT00333866|Secondary|Change From Baseline in Multidimensional Assessment of Fatigue (MAF) at Week 14|MAF is a 16-item self-administered questionnaire that yields a Global Fatigue Index (GFI), measures 4 dimensions of fatigue: degree and severity, amount of distress it causes, its timing and degree to which fatigue interferes with activities of daily living. Only 15 items are used to calculate the GFI. GFI score range from 1 (no fatigue) to 50 (severe fatigue).|Baseline, Week 14|FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||Units on a scale||Standard Error|Least Squares Mean
723886|NCT00334802|Secondary|Duration of Response|The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.|time of response to progressive disease|||months||Full Range|Median
723834|NCT00333866|Secondary|Change From Baseline in Short Form-36 (SF-36) Health Survey at Week 14|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; Physical Component Score and Mental Component Score. Total score range for the summary scores = 0- 100, where higher score represents higher level of functioning.|Baseline, Week 14|FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||Units on a scale||Standard Error|Least Squares Mean
723835|NCT00333866|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Scores at Week 14|FIQ: 20-item self-administered questionnaire designed to assess areas such as health status, progress, and outcomes in participants with fibromyalgia. 11 items related to physical functioning, other items assess pain, fatigue, stiffness, difficulty working, and symptoms of anxiousness and depression. FIQ contains 10 sub-scales scored from 0 to 10, with higher scores indicating more impairment in the subscale attribute. Total score range from 0 to 100 with higher scores indicating more impairment.|Baseline, Week 14|FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||Units on a scale||Standard Error|Least Squares Mean
723836|NCT00333866|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores at Week 14|FIQ: 20-item self-administered questionnaire designed to assess areas such as health status, progress, and outcomes in participants with fibromyalgia. 11 items related to physical functioning, other items assess pain, fatigue, stiffness, difficulty working, and symptoms of anxiousness and depression. FIQ contains 10 sub-scales scored from 0 to 10, with higher scores indicating more impairment in the subscale attribute. Total score range from 0 to 100 with higher scores indicating more impairment.|Baseline, Week 14|FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure. 'n’=participants evaluable for specified category for each arm group, respectively.||Units on a scale||Standard Error|Least Squares Mean
723837|NCT00333866|Secondary|Change From Baseline in Medical Outcomes Study (MOS): Sub-scales at Week 14|Participant-rated 12 item questionnaire assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no), as well as a 9-item overall sleep problems index. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score minus lowest possible score divided by possible raw score range*100);total score range:0-100,higher score=more intensity of attribute.|Baseline, Week 14|FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were handled using LOCF method. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n’=participants evaluable for specified category for each arm group.||Units on a scale||Standard Error|Least Squares Mean
723838|NCT00333866|Secondary|Percentage of Participants With Optimal Sleep Assessed Using MOS-SS|Participant-rated 12 item questionnaire assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no), as well as a 9-item overall sleep problems index. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score minus lowest possible score divided by possible raw score range*100);total score range:0-100,higher score=more disturbance.|Baseline, Week 14|FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were handled using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||Percentage of participants|||Number
723839|NCT00333866|Secondary|Change From Baseline in Weekly Mean Sleep Quality Score|Daily quality of sleep diary consists of 11-point NRS ranging from 0(best possible sleep) to 10(worst possible sleep). Participants rated their quality of sleep during past 24 hours, self-assessment done daily upon awakening. Baseline=Last 7 available scores before taking study medication up to and including Day 1. The weekly mean quality of sleep score was based on LS Means using mixed model repeated measures ANCOVA, with treatment, center, week, and treatment-by-week interaction in the model and the baseline mean sleep score used as the covariate. Weekly mean sleep quality score is defined as the mean of the last 7 daily sleep diary entries.|Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14|FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. 'N' (number of participants analyzed) signifies participants evaluable for this measure. 'n' participants evaluable at given time point for each group, respectively.||Units on a scale||Standard Error|Least Squares Mean
723840|NCT00333866|Secondary|Change From Baseline in Mean Sleep Quality Score at Endpoint (Up to Week 14)|Daily quality of sleep diary consists of 11-point NRS ranging from 0(best possible sleep) to 10(worst possible sleep). Participants rated their quality of sleep during past 24 hours, self-assessment done daily upon awakening. Baseline=Last 7 available scores before taking study medication up to and including Day 1. The endpoint (up to week 14) mean quality of sleep score was based on Least Squares (LS) Means using ANCOVA, with treatment group and center in the model and the baseline mean sleep score used as the covariate. Final weekly (endpoint) mean sleep quality score is defined as the mean sleep quality score from the last 7 sleep diary entries in the study while the participant was on study medication.|Baseline, Week 14|FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||Units on a scale||Standard Error|Least Squares Mean
723841|NCT00333866|Primary|Patient Global Impression of Change (PGIC)|Number of participants with categorical change in overall status. PGIC: a participant-rated instrument assessing change in participant's overall status from baseline, on a scale ranging from 1 (very much improved) to 7 (very much worse).|Week 14|FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||participants|||Number
723842|NCT00333866|Primary|Change From Baseline in Mean Pain Score at Endpoint (Up to Week 14)|Daily pain diary consists of 11-point NRS ranging from 0(no pain) to 10(worst possible pain). Participants rated their pain during past 24 hours, self-assessment done daily at awakening. Baseline=Last 7 available pain scores before taking study medication up to and including Day 1. Final weekly (endpoint) mean pain score is defined as the mean pain score from the last 7 pain diary entries in the study while the participant was on study medication.|Baseline, Week 14|Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using last observation carried forward (LOCF) method. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||Units on a scale||Standard Error|Least Squares Mean
723843|NCT00333879|Secondary|Accuracy in Selecting Appropriate Time to Cross Street|"Subject is able to state when it is safe to cross the street based on traffic on the street beside him accelerating into motion after traffic on the street in front of him coming to a stop. Subject must state is it safe to cross within 5 seconds of the cars on the street beside him accelerating into motion.
The system under test will be considered efficacious if the subject is correct at least 4 out of 5 times. This counts as being efficacious for that one subject."|4 trials over 30 minutes after 30 minutes of training|||participants|||Number
723844|NCT00333879|Primary|Accuracy in Judging Direction of Traffic at Traffic Intersection|"Standing at an intersection subject indicates when traffic is moving left to right and right to left in front of him, versus traffic moving to and away on the street parallel to his path. Subject can respond in only two ways: 1) traffic is moving on the street in front of me, or 2) traffic is moving on the street beside me.
Each trial lasts 5 minutes with a 2 minute and 30 second break between trials. Traffic stops and starts 5 times over the 5 minutes, each time moving in one of two randomly selected directions: 1) left and right in front of the subject, or 2) forward and back along the street beside the subject.
The participant must correctly state the direction of traffic at least 4 out of five times for the equipment under test to be counted as efficacious for presenting accurate 3D sound information to the participant."|4 trials over 30 minutes after 30 minutes of training|Initial pilot study design called for 16 subjects to provide data of significance based on a power analysis. Study terminated at 4 subjects when none of the subjects could identify the location of traffic vehicles when using the intervention across multiple (4) trials.||participants|||Number
723845|NCT00333970|Primary|Cognitive Performance|Change in verbal memory scores from baseline to end of active phase (2 months), measured as trials 1-5 total score on the California Verbal Learning Test -II (range 0-80, higher scores represent better performance).|baseline and 2 months|individuals who were randomized and completed 2 month assessments||units on a scale||Standard Error|Mean
723846|NCT00333983|Primary|Upper Extremity Portion of the Fugl-Meyer Motor Performance Assessment|"The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia (Fugl-Meyer, Jaasko, Leyman, Olsson, & Steglind, 1975; Gladstone, Danells, & Black, 2002).
Sections can be administered separately and the upper extremity motor portion of this measure was used as our primary outcome. Assessment items included movement, coordination, and reflex action of the shoulder, elbow, forearm, wrist, and hand. These items were scored on the basis of ability to complete using a 3-point ordinal scale where 0=cannot perform, 1=performs partially and 2=performs fully.
The total possible score for the upper extremity is 66 with a minimum range of 0 and maximum of 66. A higher score indicates a better outcome."|Baseline to Final Training (6 weeks)|The number of participants analyzed were based on an intention to treat methodology with the exception of individuals that were non-compliant with the protocol or did not progress to the midpoint (3 week) evaluation.||units on a scale||Standard Deviation|Mean
723847|NCT00334061|Secondary|Percentage of Participants With Symptomatic Hemorrhage|All treated patients were scanned by computed tomography (CT) at 24-hours post-procedure to detect the presence of intracranial hemorrhage.|24-Hour Post-Procedure|||Percentage of Participants|||Number
723848|NCT00334061|Secondary|Percentage of Participants With All Cause Mortality||90-Days Post-Treatment|||Percentage of Participants|||Number
723849|NCT00334061|Secondary|Percentage of Participants With a Modified Rankin Scale (mRS) Score of ≤ 2 at 90 Days Post Treatment|The mRS is a scale to determine the activities of daily living of the patient with a score of 0 designating normal activities to a score of 6 designating death.|90-Day|||Percentage of Participants|||Number
723850|NCT00334061|Secondary|Percentage of Participants With Either a 4-point Improvement on the National Institutes of Health Stroke Scale (NIHSS) at Discharge or a Modified Rankin Scale (mRS) Score of ≤ 2 at 30 Days After Treatment|"NIHSS is a 42 point scale to describe the neurological status of the patients:
0=no stroke; 1-15=minor to moderate stroke; 15-20=moderate/severe stroke; 21-42=severe stroke. The mRS is a scale to determine the activities of daily living of the patient with a score of 0 designating normal activities to a score of 6 designating death."|Discharge or 30-Days Post-Procedure|||Percentage of Participants|||Number
723851|NCT00334061|Primary|Percentage of Participants With Device-related and Procedure-related Serious Adverse Events||6-Month Post-Procedure|All adverse events were summarized by showing the number and percent of patients who reported the event. Events were also reported by relationship to the procedure or device. Causality of adverse events was adjudicated by a Clinical Events Committee. The denominator for the analyses was all enrolled patients.||Percentage of Participants|||Number
723852|NCT00334061|Primary|Percentage of Participants With Revascularization of the Occluded Target Vessel|"Revascularization is defined by a Thrombolysis in Myocardial Infarction (TIMI) score of 2 or 3 following use of the Penumbra System.
TIMI scores are used to describe blood flow at the treated vessel with 0 designating no flow and 3 for normal flow."|6-Month Post-Procedure|Intention to Treat||Percentage of Participants|||Number
723853|NCT00334074|Secondary|Number of Participants Who Had an Adverse Event While on Treatment With Clofarabine Plus Cytarabine|Patients will be monitored clinically and diagnostically using measures including blood test, bone marrow aspiration and MUGA. Toxicity assessment every week using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be performed.|Up to five months (includes follow up period of 30 days) from the day patient received their first dose of study drug|Intention To Treat||participants; with adverse events|||Number
724354|NCT00331760|Secondary|Local-regional Failure||From registration to date of local-regional failure (any failure in the treatment field, which will be the pelvis only) or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years.||||||
723854|NCT00334074|Primary|Response Rate (Complete Response [CR] Plus Partial Response [PR]) of Clofarabine Plus Cytarabine in Patients With Relapsed/Refractory AML, Untreated MDS, CML in Blast Phase, or in Selected Untreated Patients With High Risk of Anthracycline Toxicity|"Based on International working group for diagnosis, standardization of response criteria, and treatment outcomes for reporting standards for therapeutic trials in Acute myeloid Leukemia:
Complete Response (CR) was defined as normalization of marrow blasts (< 5%), recovery of normal heamtopoiesis (absolute neutrophil count >1 X 10^9/l, platelet count ≥100 X10^9/l, and absence of peripheral blood blasts, independent of transfusions and growth factor support.
Partial response was defined as blood count recovery as for complete response with the exception of leukemic marrow blasts in the range of 6%-25% or a ≥50% decrease in bone marrow blasts.
Treatment failure was defined as a <25% change in marrow blasts within 30 days of starting therapy"|Proportion of confirmed responses was estimated by the number of patients who achieved a CR or PR, defined as two consecutive evaluations at least 4 weeks apart, divided by the number of eligible participants in the study.|Intent to Treat analysis; per eligible participants enrolled in the study.||participants|||Number
723855|NCT00334113|Primary|7-Day Physical Activity Recall (PAR)|A self-report measure of minutes of physical activity over the previous 7 days.|six months|Participants analyzed varies from completed participants since the completed number comes from those who stayed in the study through the 12 months (6 months post intervention). In TAU, the number who completed exceeds the number analyzed since 1 participant did not show for the 6 month assessment but did show for the 12 month follow up assessment.||minutes per week||Standard Deviation|Mean
723856|NCT00334204|Primary|Need for Blood Transfusion||12|||participants requiring PRBC Transfusion|||Number
723857|NCT00334204|Primary|Hemoglobin/Hematocrit After Biopsy||12 hours|||participants with hematuria|||Number
723858|NCT00334204|Primary|Bleeding After Kidney Biopsy on Renal Ultrasound 12 Hours After Biopsy||12 hours|||participants with hematoma|||Number
723859|NCT00334282|Secondary|Baseline Expression Levels of the Indicated Target Proteins in Pazopanib- and Placebo-treated Participants|Baseline plasma samples were obtained from participants and were tested for the indicated cytokine and angiogenesis factors. Protein levels were determined using the Searchlight multiplex system based on chemiluminescence.|Baseline|Subgroup of enrolled participants who agreed to have plasma samples collected for biomarker analyses.||picograms per milliliter||Standard Deviation|Mean
723860|NCT00334282|Secondary|Plasma Pazopanib Concentrations Before Dosing and at 2, 4, and 8 Hours After Dosing on Day 1 and Week 3|The concentration of pazopanib in the plasma was measured.|Day 1 and Week 3|Subgroup of enrolled participants who agreed to have blood samples collected for analysis of pazopanib in plasma. Data were missing or not collected at Week 3 for 8 participants for whom data were available on Day 1. No samples were collected at Week 3 from 2 participants.||nanograms per milliliter||Full Range|Median
723861|NCT00334282|Secondary|Adjusted Mean Change From Baseline in the Visual Analog Scale (VAS) Score of the EQ-5D (EuroQoL [Quality of Life]-5D) Questionnaire at Weeks 6, 12, 18, 24, and 48|The EQ-5D is comprised of a 5-item health status measure and a visual analogue rating scale, and measures mobility, self-care, usual activities, pain, discomfort, and anxiety/depression. Responses to each of the 5 health states are measured on a 3-point scale (no, moderate, and extreme problems). Scoring of the EQ-5D yields an index-based summary score (Index) and a VAS score (VAS), obtained from participant’s self-reports of their health on a VAS thermometer scale. The EQ-5D VAS ranges from 0% (worst imaginable health state) to 100% (best imaginable health state).|Baseline and Weeks 6, 12, 18, 24, and 48|Participants in the ITT Population who completed HRQOL assessments at Baseline and had at least one post-Baseline assessment are included. Only participants who were on treatment at the given time point were asked to complete the questionnaire, and only those who completed the questionnaire could be analyzed for each individual time point.||points on a scale||Standard Deviation|Mean
723862|NCT00334282|Secondary|Adjusted Mean Change From Baseline in the Index Score of the EQ-5D (EuroQoL [Quality of Life]-5D) Questionnaire at Weeks 6, 12, 18, 24, and 48|The EQ-5D is comprised of a 5-item health status measure and a visual analogue rating scale, and measures mobility, self-care, usual activities, pain, discomfort, and anxiety/depression. Responses to each of the 5 health states are measured on a 3-point scale (no, moderate, and extreme problems). Scoring of the EQ-5D yields an index-based summary score (Index), through application of societal weights, and a VAS score (VAS). Index is interpreted on a continuum from 1.0 (best possible health) to 0 (represents dead), to some health sates being worse than dead (<0).|Baseline and Weeks 6, 12, 18, 24, and 48|Participants in the ITT Population who completed HRQOL assessments at Baseline and had at least one post-baseline assessment are included. Only participants who were on treatment at the given time point were asked to complete the questionnaire, and only those who completed the questionnaire could be analyzed for each individual time point.||points on a scale||Standard Deviation|Mean
723863|NCT00334282|Secondary|Adjusted Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life (QOL) Questionnaire Core 30 (EORTC QLQ C-30) Score at Weeks 6, 12, 18, 24, and 48|The EORTC QLQ-C30 is a questionnaire developed to assess the quality of life of cancer participants. The analyses for EORTC QLQ-C30 were focused on global health status/Health-Related Quality of Life (HRQOL) scores on the questionnaire. The scores (from 1 [very poor quality of life] to 7 [excellent quality of life]) for these two questions were averaged and then transformed to a 0 - 100 scale (based on published methods) prior to analysis of change from Baseline.|Baseline and Weeks 6, 12, 18, 24, and 48|Participants in the ITT Population who completed HRQOL assessments at Baseline and had at least one post-Baseline assessment are included. Only participants who were on treatment at the given time point were asked to complete the questionnaire, and only those who completed the questionnaire could be analyzed for each individual time point.||points on a scale||Standard Deviation|Mean
723864|NCT00334282|Secondary|Time to Response as Assessed by an Independent Review Committee (IRC) and the Investigator|Time to response is defined as the time from randomization until the first documented evidence of complete response (all detectable tumor has disappeared) or partial response (a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the Baseline sum) (whichever status was recorded first).|Randomization until CR or PR (assessed for up to 2 years)|ITT Population. Only participants with a complete or partial response were analyzed. Only results for pazopanib are given because there were not enough placebo responders. The different number of participants analyzed is due to differences in clinical judgement, measurement, and the selection of target lesions.||weeks||95% Confidence Interval|Median
723866|NCT00334282|Secondary|Participants With Complete Response, Partial Response, or 6 Months of Stable Disease|This is similar to overall response rate, but also includes participants who had stable disease for at least 6 months. Per Response Evaluation Criteria In Solid Tumors (RECIST): CR, all detectable tumor has disappeared; PR, a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the Baseline sum; Stable Disease, small changes that do not meet previously given criteria; Progressive Disease, a >=20% increase in target lesions. IRC, independent review committee.|Baseline until 6 months post-Baseline or progressive disease|ITT Population||participants|||Number
723867|NCT00334282|Secondary|Overall Response|Overall response is the number of participants who had a complete response (CR) or a partial response (PR). Per RECIST: CR, all detectable tumor has disappeared; PR, a >=30% decrease in the sum of the longest dimensions of the target lesions (TLs) taking as a reference the Baseline sum, no worsening of non-TLs, and no new lesions; Progressive disease (PD), a >=20% increase in TLs, clearly worsening of non-TLs, or emergence of new lesions; Stable Disease, small changes that do not meet previously given criteria. IRC, independent review committee.|Baseline until either response or progression (up to 2 years)|ITT Population||participants|||Number
723868|NCT00334282|Secondary|Overall Survival|Overall survival is defined as the time from randomization until death. The length of this interval was estimated as the date of death minus the date of randomization plus 1 day. Participants who were still alive at the time of analysis were censored.|Randomization until death (up to 2 years)|ITT Population||months||95% Confidence Interval|Median
723869|NCT00334282|Primary|Progression-free Survival|Progression-free survival (PFS) is defined as the interval between the date of randomization and the earliest date of disease progression or death due to any cause. Assessments of progression and non-progression were made by an independent imaging review committee (IRC) for the primary analysis.|Randomization until progression (up to 2 years)|Intent-to-Treat (ITT) Population: all randomized participants||months||95% Confidence Interval|Median
723870|NCT00334295|Secondary|Evaluation (Patient-reported): Change From Baseline in Health-related Quality of Life (HR-QoL) at 12 Months (12 Visits)|Patient-reported FACT-EN questionaire. Presented is the change from baseline after 12 visits/12 months. The overall total score of 43 single items was transformed to a scale from 0 to 100 (0 = worst level of well-being; 100 = highest level of well-being).|ICF (Baseline) up to 12 months (12 visits)|FACT-En was evaluated descriptively for change from baseline of the total score using the AST population, presented for the first 12 visits. Due to death or other patients individual reasons only 4 participants were motivated to complete the FACT-En questionnaire form.||units on a scale||95% Confidence Interval|Mean
723871|NCT00334295|Secondary|Determination (All Subjects Treated (AST) Set): Safety and Toxicity by Assessment of the Frequency of Grade I-IV Haematological and Non-haematological Toxicities|number of adverse events|ICF to Last Patient Out (LPO)|||adverse events|||Number
723872|NCT00334295|Secondary|Determination (for ITT Set): Median Survival|median overall survival (OS)|ICF to the date of death|||months||95% Confidence Interval|Median
723873|NCT00334295|Secondary|Time to Progression of Disease (TTP-Time To Progression, for ITT Set)|median TTP|ICF (Informed Consent Form completed) to the date of objective progression or death (by any cause in the absence of progression)|||months||95% Confidence Interval|Median
723874|NCT00334295|Primary|Determination (for ITT (Intet-to-Treat Set): Efficacy of a Monthly Administration of Fulvestrant in Patients With Recurrent or Metastatic Endometrial Carcinoma by Assessment of the Clinical Tumour Response After 3 Injections of Fulvestrant|Number of patients with Complete Remission (CR) and Partial Response (PR), as determined by an independent expert panel according to the WHO response criteria.|up to 1 year|||participants|||Number
723875|NCT00334542|Primary|Change in a Panel of Biomarkers (Contralateral Breast Density) From Baseline||Baseline and week 24|Paired baseline and post-simvastatin treatment mammograms for evaluation of breast density were available for 43 participants.||percentage of change||95% Confidence Interval|Median
723876|NCT00334542|Secondary|Prevalence of Akt and p-Akt Activation by Contralateral Core Breast Biopsies||Baseline and week 24||||||
723877|NCT00334542|Secondary|Prevalence of Breast Gene (Estrogen Receptor [ER]-α and ER-β, Cyclin D2, RAR-β, Twist, RASSF1A, and HIN-1) Hypermethylation||Baseline and week 24||||||
723878|NCT00334542|Primary|Change in a Panel of Biomarkers (High-sensitivity C-reactive Protein [hsCRP], Lipid Profile, and Circulating Estrogens) From Baseline||Baseline and week 24|Paired baseline and post-simvastatin treatment fasting lipid samples were available for 47 participants, including 45 women who completed the study and from two who discontinued the drug prior to the completion of the 24–28 weeks of drug, and are integrated in the intention-to-treat analyses||mg/dl||95% Confidence Interval|Median
723879|NCT00334633|Secondary|Recurrence of BV||12 weeks||||||
723880|NCT00334633|Primary|Cure of Bacterial Vaginosis|resolution of Amsel criteria for bacterial vaginosis|one month|ITT||participants|||Number
723881|NCT00334802|Secondary|Pharmacokinetics - Half Life (t½)|Apparent elimination half-life.|cycle 1, day 1 (0 minutes, 3, 3.25, 3.5, 3.58, 3.75, 4, 4.5, 5 hours) and 8 (0, 15, 30, 35, 45, 60, 90, 120 minutes)|Six participants from each dose level (Dose Level 1 and Dose Level 2) were assessed for pharmacokinetic variables.||hours||Full Range|Geometric Mean
723882|NCT00334802|Secondary|Pharmacokinetics - Area Under the Concentration Curve (AUC)|Area under the concentration curve from time zero to infinity.|cycle 1, day 1 (0 minutes, 3, 3.25, 3.5, 3.58, 3.75, 4, 4.5, 5 hours) and 8 (0, 15, 30, 35, 45, 60, 90, 120 minutes)|Six participants from each dose level (Dose Level 1 and Dose Level 2) were assessed for pharmacokinetic variables.||nanograms*hour per milliliter (ng*hr/mL)||Full Range|Geometric Mean
723883|NCT00334802|Secondary|Pharmacokinetics - Maximum Plasma Concentration (Cmax)|Maximum plasma concentration of gemcitabine plus paclitaxel on Day 1, Cycle 1, and gemcitabine monotherapy on Day 8, Cycle 1.|cycle 1, day 1 (0 minutes, 3, 3.25, 3.5, 3.58, 3.75, 4, 4.5, 5 hours) and 8 (0, 15, 30, 35, 45, 60, 90, 120 minutes)|Six participants from each dose level (Dose Level 1 and Dose Level 2) were assessed for pharmacokinetic variables.||nanograms per milliliter (ng/mL)||Full Range|Geometric Mean
723884|NCT00334802|Secondary|Number of Participants Alive at One Year (1-Year Survival)||baseline to date of death from any cause, evaluated at 1 year|||participants|||Number
723885|NCT00334802|Secondary|Time to Progressive Disease|Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause.|baseline to measured progressive disease|||days||Full Range|Median
723888|NCT00334815|Secondary|Response Rate (Confirmed or Unconfirmed Partial Response)|Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions.|Response assessment occured at the end of CRT and docetaxel/bevacizumab and then every 2-3 months for 2 years and then every 6 months until 4 years after the initial registration|Only patients with measurable disease at baseline were included in the analysis of response. Among 15 patients on the Low Risk stratum, 14 had measureable disease at baseline. Among 11 patients on the High Risk stratum, 10 had measureable disease at baseline.||percentage of participants||95% Confidence Interval|Number
723889|NCT00334815|Secondary|Overall Survival|From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Every week, up to 4 years|||Months||95% Confidence Interval|Median
723890|NCT00334815|Secondary|Progression-free Survival|From date of registration to time of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.|Disease assessments were performed every 10 weeks as long as the patient remained on protocol treatment, up to 4 years.|||Months||95% Confidence Interval|Median
723891|NCT00334815|Primary|Adverse Events|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Up to one year|All eligible patients, both low-risk and high-risk strata combined, who received protocol therapy.||Participants|||Number
723892|NCT00334893|Primary|Objective Response to Treatment With Eribulin Mesylate in Patients With Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer.|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|From start of treatment to 24 weeks after completion of study treatment|||participants|||Number
723893|NCT00334893|Secondary|Toxicity Profile of Eribulin Mesylate in Patients With Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer|Measured by NCI CTCAE Version 4.0. The 95% confidence intervals should be provided.|From the time of their first treatment with eribulin mesylate||||||
723894|NCT00334958|Secondary|Reduction From Baseline in Total Partial Seizure Frequency Rate (RRATIO) During Maintenance Phase|RRATIO= 100*(T-B)/(T+B) where T= total seizure frequency per 28 days during the Maintenance Phase, and B=total seizure frequency per 28 days during the Baseline Phase|Baseline, Days 13 to 96|ITT population||RRATIO||Standard Deviation|Mean
723895|NCT00334958|Secondary|Log10 Transformed Total Partial Seizure Frequency Per 28 Days During the Baseline Phase and Maintenance Phase|Total partial seizure frequencies per 28 days during the double-blind Maintenance and Baseline Phases were transformed using logarithms to the base 10 (log10), because it was expected from previous studies that the results would not be normally distributed.|Days 13 to 96|ITT population||Seizures per 28-days (log-transformed)||Standard Deviation|Mean
723896|NCT00334958|Secondary|Percentage of Participants With 50% or Greater Reduction in Total Partial Seizure Frequency Per 28 Days During the Maintenance Phase Relative to the Baseline Phase|There are 2 major categories of seizures in epilepsy: generalized and partial (focal) seizures. The most frequent type is partial onset seizures. For inclusion in this study, participants needed to have a diagnosis of epilepsy with partial onset seizures with or without secondarily generalized seizures according to the International League Against Epilepsy Classification of Epileptic Seizures. Seizure data was collected via patient diary, which was used to record daily seizure count and type.|Baseline, Days 13 to 96|ITT population||Percentage of Participants|||Number
723897|NCT00334958|Primary|Percentage Change in Total Partial Seizure Frequency Per 28 Days During Maintenance Phase Relative to the Baseline Phase|There are 2 major categories of seizures in epilepsy: generalized and partial (focal) seizures. The most frequent type is partial onset seizures. For inclusion in this study, participants needed to have a diagnosis of epilepsy with partial onset seizures with or without secondarily generalized seizures according to the International League Against Epilepsy Classification of Epileptic Seizures. Seizure data was collected via patient diary, which was used to record daily seizure count and type.|Baseline, Days 13 to 96|Intent-to-treat (ITT) population: All randomized subjects who had baseline Patient Seizure Diary data and had at least completed the titration period||Percentage change||Full Range|Median
723898|NCT00335140|Primary|Complete Response Rate - Locally Reviewed|"Assessed by the ECOG-ACRIN data manager based upon local review of images and data sent by the local sites.
Treatment response was determined by calculating the sum of the maximal cross section in 2 separate axes using enhancing lesion(s) on CT or MRI imaging. The same imaging modality was to be used throughout assessment. Complete response was defined as the disappearance of all contrast enhancing tumor size on CT or MRI, patient was off all glucocorticoids, and resolution of all meningeal and vitreous involvement if present. Response must have lasted at least 4 weeks."|For the primary endpoint, complete response will be based on disease status at three weeks post the end of therapy (week 17).|Eligible, treated patients||percentage of participants||95% Confidence Interval|Number
723899|NCT00335153|Primary|Number of Participants Taking at Least 1 Concomitant Medication During the Study|Concomitant medications include those started on or after the first open-label LCIG infusion as well as medications started prior to the first open-label infusion but continued during the study.|Screening up to Day 378|Safety Data Set: participants who were allocated to treatment, had started placement of NJ tube, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded).||participants|||Number
723900|NCT00335153|Primary|Number of Participants With Confirmed Cases of Melanoma|A comprehensive assessment for the presence of melanoma was performed during the screening period and at early termination or end of study by a dermatologist experienced with the diagnosis of the condition. If a suspicious lesion was present, a biopsy was obtained for proper diagnosis.|Screening up to Day 378|Safety Data Set: participants who were allocated to treatment, had started placement of NJ tube, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded).||participants|||Number
723979|NCT00328627|Secondary|Change From Baseline to Week 12 in Apolipoprotein A1|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A1 as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
723901|NCT00335153|Secondary|Change From Baseline in Zarit Burden Interview (ZBI) Total Score at Endpoint|The ZBI is a 22-item questionnaire regarding the caregiver/subject relationship and evaluates the caregiver's health condition, psychological well-being, finances and social life. Each question is answered on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=quite frequently, and 4=nearly always). The caregiver burden is evaluated by the total score (Range 0 to 88) obtained from the sum of the answers to the 22 questions. Higher scores are associated with a higher level of burden for the caregiver.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.||units on a scale||Standard Deviation|Mean
723902|NCT00335153|Secondary|Change From Baseline in EuroQol Quality of Life Scale (EQ-5D) Visual Analogue Scale (VAS) at Endpoint|The EQ-5D VAS records the participant's self-rated health on a scale from 0-100 where 100 is the 'best imaginable health state' and 0 is the 'worst imaginable health state'.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.||units on a scale||Standard Deviation|Mean
723903|NCT00335153|Secondary|Change From Baseline in EuroQol Quality of Life Scale (EQ-5D) Summary Index at Endpoint|The EQ-5D is a participant answered questionnaire scoring 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that essentially attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 to 1.00 with positive change indicating improvement.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.||units on a scale||Standard Deviation|Mean
723904|NCT00335153|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Bodily Discomfort Domain Score at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Bodily Discomfort includes 3 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.||units on a scale||Standard Deviation|Mean
723905|NCT00335153|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Communication Domain Score at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Communication includes 3 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.||units on a scale||Standard Deviation|Mean
723906|NCT00335153|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Cognition Domain Score at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Cognition includes 4 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.||units on a scale||Standard Deviation|Mean
723907|NCT00335153|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Social Support Domain Score at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Social Support includes 3 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.||units on a scale||Standard Deviation|Mean
724044|NCT00328627|Secondary|Change From Baseline to Week 4 in Proinsulin/Insulin Ratio|"The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (μIU/mL).
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin/insulin ratio as continuous covariates."|Baseline and Week 4|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||ratio||Standard Error|Least Squares Mean
723908|NCT00335153|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Stigma Domain Score at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Stigma (e.g., social embarrassment) consists of 4 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.||units on a scale||Standard Deviation|Mean
723909|NCT00335153|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Emotional Well-Being Domain Score at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Emotional Well-being (e.g., feelings of isolation) includes 6 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.||units on a scale||Standard Deviation|Mean
723910|NCT00335153|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Activities of Daily Living Domain Score at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Activities of Daily Living (e.g., difficulty cutting food) includes 6 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.||units on a scale||Standard Deviation|Mean
723911|NCT00335153|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Mobility Domain Score at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Mobility (e.g., fear of falling when walking) includes 10 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.||units on a scale||Standard Deviation|Mean
723912|NCT00335153|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson’s disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The PDQ-39 Summary Index is the sum of all answers divided by the highest score possible (i.e. number of answers multiplied by 4) which is multiplied by 100 to put the score on a 0-100 scale. Higher scores are associated with more severe symptoms.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.||units on a scale||Standard Deviation|Mean
723913|NCT00335153|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score at Endpoint|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part IV Score is the sum of the answers to the 11 questions that comprise Part IV, each of which are measured on a 5-point scale (0-4) or a 2-point scale (0 or 1). The Part IV score ranges from 0-23 and higher scores are associated with more disability.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.||units on a scale||Standard Deviation|Mean
723914|NCT00335153|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Endpoint|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The total score is the sum of the responses to the 31 questions (44 answers) that comprise Parts I-III of the scale. The total score will range from 0-176, with 176 representing the worst (total) disability, and 0 representing no disability.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.||units on a scale||Standard Deviation|Mean
724355|NCT00331760|Secondary|Chemotherapy Compliance for Cervical Carcinoma Patients||Chemotherapy treatment is centrally reviewed for quality assurance and compliance.||||||
724356|NCT00331760|Secondary|All Other Adverse Events||From start of treatment to the end of follow-up.||||||
723915|NCT00335153|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at Endpoint|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part III score is the sum of the 27 answers provided to the 14 Part III questions, each of which are measured on a 5-point scale (0-4). The Part III score ranges from 0-108 and higher scores are associated with more disability.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.||units on a scale||Standard Deviation|Mean
723916|NCT00335153|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at Endpoint|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part II score is the sum of the answers to the 13 questions that comprise Part II, each of which are measured on a 5-point scale (0-4). The Part II score ranges from 0-52 and higher scores are associated with more disability.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.||units on a scale||Standard Deviation|Mean
723917|NCT00335153|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score at Month 12|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part I Score is the sum of the answers to the 4 questions that comprise Part I, each of which are measured on a 5-point scale (0-4). The Part I score ranges from 0-16 and higher scores are associated with more disability.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.||units on a scale||Standard Deviation|Mean
723918|NCT00335153|Secondary|Clinical Global Impression - Status (CGI-S) Score at Baseline and Clinical Global Impression - Improvement (CGI-I) Score at Endpoint|The CGI-S is a global assessment by the Investigator of current symptomatology and impact of illness on functioning. The ratings of the CGI-S are as follows: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, and 7 = among the most extremely ill. The CGI-I is a global assessment by the Investigator of the change in clinical status since the start of treatment. The CGI-I ratings are as follows: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.||units on a scale||Standard Deviation|Mean
723919|NCT00335153|Secondary|"Change From Baseline in Average Daily On Time Without Troublesome Dyskinesia at Endpoint"|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. On time without troublesome dyskinesia (involuntary muscle movement) is defined as on time without dyskinesia and on time with non-troublesome dyskinesia. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Positive change from Baseline for on time without troublesome dyskinesia indicates improvement."|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.||hours||Standard Deviation|Mean
723920|NCT00335153|Secondary|"Change From Baseline in Average Daily Normalized On Time With Troublesome Dyskinesia at Endpoint"|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis."|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.||hours||Standard Deviation|Mean
723921|NCT00335153|Secondary|"Change From Baseline in Average Daily Off Time at Endpoint"|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Negative change from baseline for off time indicates improvement."|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.||hours||Standard Deviation|Mean
723930|NCT00335153|Primary|Number of Participants With Device Complications During the Percutaneous Endoscopic Gastrostomy – With Jejunal Extension Tube (PEG-J) Surgery and Post-PEG Long Term Treatment Periods|Complications of the infusion device were collected during the PEG-J Surgery and Post-PEG Long-Term Treatment periods. Pump, PEG-J, stoma, and other complications included (but were not limited to) device breakage, device leakage, device malfunction, device misuse, device occlusion, intentional and unintentional device removal by participant, complication of device insertion, device dislocation, device breakage, device dislocation, and post-procedural hemorrhage.|PEG-J Surgery Period (from 2 to 14 days) through the Long Term Treatment Period (Day 28 to Day 378)|Post-PEG Safety Data Set: participants who continued to the PEG-J surgery, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded).||participants|||Number
723922|NCT00335153|Primary|Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score at Endpoint|"The AIMS is an investigator-completed rating scale that has a total of 12 items rating involuntary movements of various areas of the participant's body. Items 1 through 10 are rated on a 5-point scale of severity from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), to 4 (severe), and items 11 and 12 are yes/no questions regarding issues with teeth or dentures. The total AIMS score was calculated by summing items 1-10, with a possible range of 0-40; a negative change indicates improvement. The AIMS was to be performed at consistent times, when the subject was experiencing his/her worst On time (dyskinesia [involuntary muscle movement])."|Baseline, Endpoint (last Post-PEG Long-Term Period visit up to Day 378)|Post-PEG Safety Data Set: participants who continued to the PEG-J surgery, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded); n=number of participants with assessment at timepoint.||units on a scale||Standard Deviation|Mean
723923|NCT00335153|Primary|Summary of Minnesota Impulsive Disorder Interview (MIDI) Assessment of Intense Impulsive Behavior at Baseline (BL) and During the Post-PEG Long-term Treatment (PPLT) Period|The MIDI is a validated assessment of impulsive behavior consisting of a semistructured clinical interview assessing pathological gambling, trichotillomania (compulsive hair-pulling), kleptomania (compulsive stealing), pyromania (compulsive fire setting), intermittent explosive disorder, compulsive buying, and compulsive sexual behavior.|Baseline, during the Post-PEG Long-term Treatment Period (Day 28 through Day 378)|Post-PEG Safety Data Set: participants who continued to the PEG-J surgery, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded); n=number of participants with an assessment at timepoint.||participants|||Number
723924|NCT00335153|Primary|Number of Participants With Sleep Attacks During the Post-PEG Long-Term Treatment Period|To prospectively monitor for the possible development of sleep attacks, participants were asked if they had experienced any events in which they fell asleep suddenly or unexpectedly, including while engaged in some activity (e.g., eating/drinking, speaking, or driving) or at rest, with or without any previous warning of sleepiness. Those participants who reported 1 or more sleep attacks were asked to report the number of sleep attacks they experienced, whether they experienced sleepiness or drowsiness prior to the sleep attack, whether they experienced a 'bad' outcome or problem due to a sleep attack, and if so, how many 'bad' outcomes or problems they experienced.|During the Post-PEG Long-Term Treatment Period (Day 28 through Day 378)|Post-PEG Safety Data Set: participants who continued to the PEG-J surgery, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded) who had an assessment.||participants|||Number
723925|NCT00335153|Primary|Number of Participants With Sleep Attacks at Baseline|To prospectively monitor for the possible development of sleep attacks, participants were asked if they had experienced any events in which they fell asleep suddenly or unexpectedly, including while engaged in some activity (e.g., eating/drinking, speaking, or driving) or at rest, with or without any previous warning of sleepiness. Those participants who reported 1 or more sleep attacks were asked to report the number of sleep attacks they experienced, whether they experienced sleepiness or drowsiness prior to the sleep attack, whether they experienced a 'bad' outcome or problem due to a sleep attack, and if so, how many 'bad' outcomes or problems they experienced.|Baseline|Post-PEG Safety Data Set: participants who continued to the PEG-J surgery, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded).||participants|||Number
723926|NCT00335153|Primary|Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Parameters|Terms abbreviated in the table include heart rate (HR) in beats per minute (bpm), PR interval (PRI), QT interval corrected for heart rate using Bazett's formula (QTcB), and QT interval corrected for heart rate using Fridericia's formula (QTcF). Increase and decrease are signified by ↑ and ↓, respectively.|Screening through Day 378|Post-PEG Safety Data Set: participants who continued to the PEG-J surgery, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded); n=number of participants with given assessment.||participants|||Number
723927|NCT00335153|Primary|Number of Participants With Potentially Clinically Significant Vital Sign Parameters|Terms abbreviated in the table include supine systolic blood pressure (SuSBP), standing systolic blood pressure (StSBP), orthostatic systolic blood pressure (OSBP), supine diastolic blood pressure (SuDBP), standing diastolic blood pressure (StDBP), orthostatic diastolic blood pressure (ODBP), supine pulse (SuP) in beats per minute (bpm), standing pulse (StP), and body temperature (Temp). Increase and decrease are signified by ↑ and ↓, respectively.|up to 56 weeks|Post-PEG Safety Data Set: participants who continued to the PEG-J surgery, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded); n=number of participants with assessment.||participants|||Number
723928|NCT00335153|Primary|Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters|Terms abbreviated in the table include aspartate aminotransferase (AST), upper limit of normal (ULN), alanine aminotransferase (ALT), gamma-glutamyl transpeptidase (GGT), lactate dehydrogenase (LDH), blood urea nitrogen (BUN), female (f), and male (m).|Screening through Day 378|Post-PEG Safety Data Set: participants who continued to the PEG-J surgery, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded); n=number of participants with assessment.||participants|||Number
723929|NCT00335153|Primary|Number of Participants With Potentially Clinically Significant Values for Hematology Parameters|Potentially clinically significant values for red blood cells (RBCs), hemoglobin, and hematocrit are specified for females (f) and males (m) separately in the category rows.|Screening through Day 378|Post-PEG Safety Data Set: participants who continued to the PEG-J surgery, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded); n=number of participants with assessment.||participants|||Number
723955|NCT00328627|Secondary|Change From Baseline to Week 12 in Mean VLDL Particle Size|"The change from Baseline in mean VLDL particle size was assessed by NMR lipid fractionation.
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean VLDL particle size as continuous covariates."|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||nm||Standard Error|Least Squares Mean
723931|NCT00335153|Primary|Number of Participants With Device Complications During the Nasojejunal (NJ) Test Period|Complications of the infusion device were collected during the NJ Test period. Pump, intestinal tube, NJ tube, and other complications included (but were not limited to) device breakage, device leakage, device malfunction, device misuse, device occlusion, intentional and unintentional device removal by participant, complication of device insertion, device dislocation, device breakage, device dislocation, and post-procedural hemorrhage.|NJ Test Period (from 2 to 14 days)|Safety Data Set: participants who were allocated to treatment, had started placement of NJ tube, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded).||participants|||Number
723932|NCT00335153|Primary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations Due to AEs|AE=any untoward medical occurrence which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that: results in death; is life-threatening (an event in which the subject was at risk of death at the time of the event); requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or other important medical events. Treatment-emergent events (TEAE or TESAE)=those starting after the first dose of study drug. Severe=severity reported as 'severe' or missing. Possibly or Probably Treatment Related=drug-event relationship reported as 'possible', 'probable' or missing. Death=a fatal outcome of an SAE or AE.|Screening through Day 378 + 30 days|Safety Data Set: participants who were allocated to treatment, had started placement of NJ tube, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded).||participants|||Number
723933|NCT00328510|Primary|Distance From Ideal to Center of GTC Frame and BrainLab Thermoplastic Mask With Respect to Average and Variability|This study uses the ExacTRAC imaging system to assess positioning of frame or mask during SRT. Images yield lateral, longitudinal, and vertical deviations of the isocenter as well as head rotations about respective axes.|Measurements taken during SRT|||millimeters|Participants|Standard Deviation|Mean
723934|NCT00328562|Secondary|Survival From Starting Gefitinib||Baseline to date of expiration|||months||Full Range|Median
723935|NCT00328562|Secondary|Progression-free Survival||Baseline to date of progression|||months||Full Range|Median
723936|NCT00328562|Secondary|Tumor Response|"Definitions of objective tumor response
Complete response - disappearance of all target lesions
Partial response - at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter
Progressive disease - at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions
Stable disease - neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started"|Baseline, 1, 3, and 5 months post-treatment|||participants|||Number
723937|NCT00328562|Primary|Patients Affected by Treatment-related Morbidities|"See Adverse Events section for specific toxicities"|Twice weekly during RT and at 1-, 2-, 3-, 4-, 5-, and 6-month points after therapy|||participants|||Number
723938|NCT00328614|Primary|Maximum Tolerated Dose of Samarium-153|"To determine the maximum tolerated dose (MTD) of Samarium as adjuvant to combined hormonal therapy (HT) and external beam radiation therapy (RT).
Dose levels:
Dose I: 0.25 mCi/kg IV Dose II: 0.5 mCi/kg IV Dose III: 0.75 mCi/kg IV Dose IV: 1.0 mCi/kg IV Dose V: 1.5 mCi/kg IV Dose VI: 2.0 mCi/kg IV
Dose-limiting toxicity will be defined as Grade 3 hematologic toxicity per NCI Common Toxicity Criteria. The maximally tolerated dose (MTD) will then be the last dose studied or the previous dose, based on clinical judgment of the degree of toxicity seen at the last dose."|5 months (1 month HT, administration of drug, 4 months HT and RT)|||mCi/kg|||Number
723939|NCT00328627|Secondary|Change From Baseline to Week 26 in Mean HDL Particle Size|The change from Baseline in mean HDL particle size was assessed by NMR lipid fractionation. Least squares means are from are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean HDL particle size as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||nm||Standard Error|Least Squares Mean
723940|NCT00328627|Secondary|Change From Baseline to Week 12 in Mean HDL Particle Size|The change from Baseline in mean HDL particle size was assessed by NMR lipid fractionation. Least squares means are from are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean HDL particle size as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||nm||Standard Error|Least Squares Mean
723941|NCT00328627|Secondary|Change From Baseline in Mean HDL Particle Size Over Time (Grouped Analysis)|"The change from Baseline in mean HDL particle size was assessed by NMR lipid fractionation at Weeks 12 and 26.
This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean HDL particle size as continuous covariates."|Baseline and Weeks 12 and 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||nm||Standard Error|Least Squares Mean
723942|NCT00328627|Secondary|Change From Baseline to Week 26 in HDL Particles|"The change from Baseline in levels of total, large, medium and small HDL particles was assessed by NMR lipid fractionation.
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR HDL particles as continuous covariates."|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||μmol/L||Standard Error|Least Squares Mean
723943|NCT00328627|Secondary|Change From Baseline to Week 12 in HDL Particles|"The change from Baseline in levels of total, large, medium and small HDL particles was assessed by NMR lipid fractionation.
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR HDL particles as continuous covariates."|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||μmol/L||Standard Error|Least Squares Mean
723944|NCT00328627|Secondary|Change From Baseline in High Density Lipoprotein (HDL) Particles Over Time (Grouped Analysis)|"The change from Baseline in levels of total, large, medium and small HDL particles was assessed by NMR fractionation at Weeks 12 and 26.
This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR HDL particles as continuous covariates."|Baseline and Weeks 12 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||μMOL/L||Standard Error|Least Squares Mean
723945|NCT00328627|Secondary|Change From Baseline to Week 26 in Mean LDL Particle Size|"The change from Baseline in mean LDL particle size was assessed by NMR lipid fractionation.
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean LDL particle size as continuous covariates."|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||nm||Standard Error|Least Squares Mean
723946|NCT00328627|Secondary|Change From Baseline to Week 12 in Mean LDL Particle Size|"The change from Baseline in mean LDL particle size was assessed by NMR lipid fractionation.
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean LDL particle size as continuous covariates."|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||nm||Standard Error|Least Squares Mean
723947|NCT00328627|Secondary|Change From Baseline in Mean LDL Particle Size Over Time (Grouped Analysis)|"The change from Baseline in mean LDL particle size was assessed by NMR lipid fractionation at Weeks 12 and 26.
This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone.
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean LDL particle size as continuous covariates."|Baseline and Weeks 12 and 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||nm||Standard Error|Least Squares Mean
723948|NCT00328627|Secondary|Change From Baseline to Week 26 in LDL Particles|"The change from Baseline in levels of total, large, medium-small, total small and very small LDL particles was assessed by NMR lipid fractionation.
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR LDL particles as continuous covariates."|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||nmol/L||Standard Error|Least Squares Mean
723949|NCT00328627|Secondary|Change From Baseline to Week 12 in LDL Particles|"The change from Baseline in levels of total, large, medium-small, total small and very small LDL particles was assessed by NMR lipid fractionation.
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR LDL particles as continuous covariates."|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||nmol/L||Standard Error|Least Squares Mean
723950|NCT00328627|Secondary|Change From Baseline in Low Density Lipoprotein (LDL) Particles Over Time (Grouped Analysis)|"The change from Baseline in levels of total, large, medium-small, total small and very small LDL particles was assessed by NMR fractionation at Weeks 12 and 26.
This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR LDL particles as continuous covariates."|Baseline and Weeks 12 and 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||nmol/L||Standard Error|Least Squares Mean
723951|NCT00328627|Secondary|Change From Baseline to Week 26 in IDL Particles|"The change from Baseline in levels of IDL particles was assessed by NMR lipid fractionation.
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR IDL particles as continuous covariates."|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||nmol/L||Standard Error|Least Squares Mean
723952|NCT00328627|Secondary|Change From Baseline to Week 12 in IDL Particles|"The change from Baseline in levels of IDL particles was assessed by NMR lipid fractionation.
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR IDL particles as continuous covariates."|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||nmol/L||Standard Error|Least Squares Mean
723953|NCT00328627|Secondary|Change From Baseline in Intermediate Density Lipoprotein (IDL) Particles Over Time (Grouped Analysis)|"The change from Baseline in levels of IDL particles was assessed by NMR lipid fractionation at Weeks 12 and 26.
This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR IDL particles as continuous covariates."|Baseline and Weeks 12 and 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||nmol/L||Standard Error|Least Squares Mean
723954|NCT00328627|Secondary|Change From Baseline to Week 26 in Mean VLDL Particle Size|"The change from Baseline in mean VLDL particle size was assessed by NMR lipid fractionation.
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean VLDL particle size as continuous covariates."|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||nm||Standard Error|Least Squares Mean
723956|NCT00328627|Secondary|Change From Baseline in Mean VLDL Particle Size Over Time (Grouped Analysis)|"The change from Baseline in mean VLDL particle size was assessed by NMR lipid fractionation at Weeks 12 and 26.
This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean VLDL particle size as continuous covariates."|Baseline and Weeks 12 and 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||nm||Standard Error|Least Squares Mean
723957|NCT00328627|Secondary|Change From Baseline to Week 26 in VLDL Particles|"The change from Baseline in levels of medium VLDL particles and small VLDL particles was assessed by NMR lipid fractionation.
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL particles as continuous covariates"|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||nmol/L||Standard Error|Least Squares Mean
723958|NCT00328627|Secondary|Change From Baseline to Week 12 in VLDL Particles|"The change from Baseline in levels of medium VLDL particles and small VLDL particles was assessed by NMR lipid fractionation.
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL particles as continuous covariates."|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||nmol/L||Standard Error|Least Squares Mean
723959|NCT00328627|Secondary|Change From Baseline in VLDL Particles Over Time (Grouped Analysis)|"The change from Baseline in levels of medium VLDL particles and small VLDL particles was assessed by NMR fractionation at Weeks 12 and 26.
This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL particles as continuous covariates."|Baseline and Weeks 12 and 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||nmol/L||Standard Error|Least Squares Mean
723960|NCT00328627|Secondary|Change From Baseline to Week 26 in VLDL / Chylomicron Triglycerides|The change from Baseline in VLDL/chylomicron triglyceride levels was assessed by NMR lipid fractionation. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL/chylomicron triglycerides as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
723961|NCT00328627|Secondary|Change From Baseline to Week 12 in VLDL / Chylomicron Triglycerides|The change from Baseline in VLDL/chylomicron triglyceride levels was assessed by NMR lipid fractionation. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL/chylomicron triglycerides as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
723962|NCT00328627|Secondary|Change From Baseline in VLDL / Chylomicron Triglycerides Over Time (Grouped Analysis)|"The change from Baseline in levels of VLDL/chylomicron triglycerides was assessed by NMR lipid fractionation at Weeks 12 and 26.
This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL/chylomicron triglycerides as continuous covariates."|Baseline and Weeks 12 and 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
723963|NCT00328627|Secondary|Change From Baseline to Week 26 in VLDL / Chylomicron Particles|"The change from Baseline in levels of total VLDL/chylomicron particles and large VLDL/chylomicron particles was assessed by NMR lipid fractionation.
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL/chylomicron particles as continuous covariates."|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||nmol/L||Standard Error|Least Squares Mean
723964|NCT00328627|Secondary|Change From Baseline to Week 12 in VLDL / Chylomicron Particles|"The change from Baseline in levels of total VLDL/chylomicron particles and large VLDL/chylomicron particles was assessed by NMR lipid fractionation.
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL/chylomicron particles as continuous covariates."|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||nmol/L||Standard Error|Least Squares Mean
723965|NCT00328627|Secondary|Change From Baseline in Very Low Density Lipoprotein (VLDL) / Chylomicron Particles Over Time (Grouped Analysis)|"The change from Baseline in levels of total VLDL/chylomicron particles and large VLDL/chylomicron particles was assessed by NMR lipid fractionation at Weeks 12 and 26.
This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL/chylomicron particles as continuous covariates."|Baseline and Weeks 12 and 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||nmol/L||Standard Error|Least Squares Mean
723978|NCT00328627|Secondary|Change From Baseline to Week 26 in Apolipoprotein A1|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A1 as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
723966|NCT00328627|Secondary|Change From Baseline to Week 26 in NMR Lipid Fractionation Total Triglycerides|"NMR lipid fractionation was used to assess the change from Baseline in total triglyceride levels at Week 26.
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR total triglycerides as continuous covariates."|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
723967|NCT00328627|Secondary|Change From Baseline to Week 12 in NMR Lipid Fractionation Total Triglycerides|"NMR lipid fractionation was used to assess the change from Baseline in total triglyceride levels at Week 12.
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR total triglycerides as continuous covariates."|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
723968|NCT00328627|Secondary|Change From Baseline in Nuclear Magnetic Resonance Lipid Fractionation Total Triglycerides Over Time (Grouped Analysis)|"Nuclear Magnetic Resonance (NMR) lipid fractionation was used to assess the change from Baseline in total triglyceride levels at Weeks 12 and 26.
This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR total triglycerides as continuous covariates."|Baseline and Weeks 12 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
723969|NCT00328627|Secondary|Change From Baseline to Week 26 in Apolipoprotein C-III|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein C-III as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
723970|NCT00328627|Secondary|Change From Baseline to Week 12 in Apolipoprotein C-III|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein C-III as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
723971|NCT00328627|Secondary|Change From Baseline in Apolipoprotein C-III Over Time (Grouped Analysis)|Change from Baseline in apolipoprotein C-III was assessed at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein C-III as continuous covariates.|Baseline and Weeks 12 and 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
723972|NCT00328627|Secondary|Change From Baseline to Week 26 in Apolipoprotein B|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein B as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
723973|NCT00328627|Secondary|Change From Baseline to Week 12 in Apolipoprotein B|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein B as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
723974|NCT00328627|Secondary|Change From Baseline in Apolipoprotein B Over Time (Grouped Analysis)|Change from Baseline in Apolipoprotein B was assessed at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein B as continuous covariates.|Baseline and Weeks 12 and 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
723975|NCT00328627|Secondary|Change From Baseline to Week 26 in Apolipoprotein A2|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A2 as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
723976|NCT00328627|Secondary|Change From Baseline to Week 12 in Apolipoprotein A2|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A2 as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
723977|NCT00328627|Secondary|Change From Baseline in Apolipoprotein A2 Over Time (Grouped Analysis)|Change from Baseline in Apolipoprotein A2 was assessed at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A2 as continuous covariates.|Baseline and Weeks 12 and 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
724357|NCT00331760|Secondary|Grade 2+ Bowel Adverse Events (Diarrhea, Enteritis, Fistula, Ileus; Gastrointestinal (GI), Incontinence; Anal, Necrosis; GI, Obstruction; GI, Perforation; GI, Proctitis and Stricture/Stenosis (Including Anastomotic) as Graded by CTCAE v. 3.0)||From the start of treatment to 90 days.||||||
723980|NCT00328627|Secondary|Change From Baseline in Apolipoprotein A1 Over Time (Grouped Analysis)|Change from Baseline in Apolipoprotein A1 was assessed at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A1 as continuous covariates.|Baseline and Weeks 12 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
723981|NCT00328627|Secondary|Change From Baseline to Week 26 in Calculated HOMA Beta-cell Function|"The Homeostasis Model Assessment (HOMA) estimates steady state beta cell function (%B) as a percentage of a normal reference population.
HOMA %B = 20 * insulin (µIU/mL) / fasting plasma glucose (mmol/L) - 3.5. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HOMA beta cell function as continuous covariates."|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||percentage beta cell function||Standard Error|Least Squares Mean
723982|NCT00328627|Secondary|Change From Baseline to Week 12 in Calculated HOMA Beta-cell Function|"The Homeostasis Model Assessment (HOMA) estimates steady state beta cell function (%B) as a percentage of a normal reference population.
HOMA %B = 20 * insulin (µIU/mL) / fasting plasma glucose (mmol/L) - 3.5. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HOMA beta cell function as continuous covariates."|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||percentage beta cell function||Standard Error|Least Squares Mean
723983|NCT00328627|Secondary|Change From Baseline in Homeostatic Model Assessment Beta Cell Function (Grouped Analysis)|"The homeostatic model assessment estimates steady state beta cell function as a percentage of a normal reference population (%B).
HOMA %B = 20 * insulin (µIU/mL) / fasting plasma glucose (mmol/L) - 3.5.
This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HOMA beta cell function as continuous covariates."|Baseline and Weeks 12 and 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||percentage beta cell function||Standard Error|Least Squares Mean
723984|NCT00328627|Secondary|Change From Baseline to Week 26 in Calculated HOMA Insulin Resistance|"The Homeostasis Model Assessment of insulin resistance (HOMA IR) measures insulin resistance based on fasting glucose and insulin measurements:
HOMA IR = fasting plasma insulin (µIU/mL) * fasting plasma glucose (mmol/L) / 22.5.
A higher number indicates a greater degree of insulin resistance. Least Squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and HOMA-IR as continuous covariates."|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||insulin resistance||Standard Error|Least Squares Mean
723985|NCT00328627|Secondary|Change From Baseline to Week 12 in Calculated HOMA Insulin Resistance|"The Homeostasis Model Assessment of insulin resistance (HOMA IR) measures insulin resistance based on fasting glucose and insulin measurements:
HOMA IR = fasting plasma insulin (µIU/mL) * fasting plasma glucose (mmol/L) / 22.5.
A higher number indicates a greater degree of insulin resistance. Least Squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and HOMA-IR as continuous covariates."|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||insulin resistance||Standard Error|Least Squares Mean
723986|NCT00328627|Secondary|Change From Baseline in Calculated Homeostatic Model Assessment Insulin Resistance (HOMA IR) (Grouped Analysis)|"HOMA IR measures insulin resistance based on fasting glucose and insulin measurements:
HOMA IR = fasting plasma insulin (µIU/mL) * fasting plasma glucose (mmol/L) / 22.5.
A higher number indicates a greater insulin resistance. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone.
Least Squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and HOMA-IR as continuous covariates."|Baseline and Weeks 12 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||insulin resistance||Standard Error|Least Squares Mean
723987|NCT00328627|Secondary|Change From Baseline to Week 26 in Body Weight|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline weight as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||kg||Standard Error|Least Squares Mean
723988|NCT00328627|Secondary|Change From Baseline to Week 20 in Body Weight|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline weight as continuous covariates.|Baseline and Week 20|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||kg||Standard Error|Least Squares Mean
723989|NCT00328627|Secondary|Change From Baseline to Week 12 in Body Weight|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline weight as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||kg||Standard Error|Least Squares Mean
723990|NCT00328627|Secondary|Change From Baseline to Week 8 in Body Weight|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline weight as continuous covariates.|Baseline and Week 8|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||kg||Standard Error|Least Squares Mean
723991|NCT00328627|Secondary|Change From Baseline in Body Weight Over Time (Grouped Analysis)|Change from Baseline in body weight was assessed at Weeks 8, 12, 20 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline weight as continuous covariates.|Baseline and Weeks 8, 12, 20 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||kg||Standard Error|Least Squares Mean
723992|NCT00328627|Secondary|Change From Baseline to Week 26 in Adiponectin|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline adiponectin as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||μg/mL||Standard Error|Least Squares Mean
723993|NCT00328627|Secondary|Change From Baseline to Week 12 in Adiponectin|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline adiponectin as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||μg/mL||Standard Error|Least Squares Mean
723994|NCT00328627|Secondary|Change From Baseline in Adiponectin Over Time (Grouped Analysis)|Change from Baseline in adiponectin was assessed at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline adiponectin as continuous covariates.|Baseline and Weeks 12 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||μg/mL||Standard Error|Least Squares Mean
723995|NCT00328627|Secondary|Change From Baseline to Week 26 in High-sensitivity C-Reactive Protein|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline hsCRP as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/L||Standard Error|Least Squares Mean
723996|NCT00328627|Secondary|Change From Baseline to Week 12 in High-sensitivity C-Reactive Protein|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline hsCRP as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/L||Standard Error|Least Squares Mean
723997|NCT00328627|Secondary|Change From Baseline in High-sensitivity C-Reactive Protein Over Time (Grouped Analysis)|"Change from Baseline in high-sensitivity C-Reactive Protein (hsCRP) was assessed at Weeks 12 and 26.
This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline hsCRP as continuous covariates."|Baseline and Weeks 12 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/L||Standard Error|Least Squares Mean
723998|NCT00328627|Secondary|Change From Baseline to Week 26 in Plasminogen Activator Inhibitor-1|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline PAI-1 as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||ng/mL||Standard Error|Least Squares Mean
723999|NCT00328627|Secondary|Change From Baseline to Week 12 in Plasminogen Activator Inhibitor-1|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline PAI-1 as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||ng/mL||Standard Error|Least Squares Mean
724000|NCT00328627|Secondary|Change From Baseline in Plasminogen Activator Inhibitor-1 Over Time (Grouped Analysis)|"Change from Baseline in plasminogen activator inhibitor-1 (PAI-1) was assessed at Weeks 12 and 26.
This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline PAI-1 as continuous covariates."|Baseline and Weeks 12 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||ng/mL||Standard Error|Least Squares Mean
724001|NCT00328627|Secondary|Change From Baseline to Week 26 in Free Fatty Acids|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline free fatty acid as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mmol/L||Standard Error|Least Squares Mean
724002|NCT00328627|Secondary|Change From Baseline to Week 12 in Free Fatty Acids|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline free fatty acid as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mmol/L||Standard Error|Least Squares Mean
724072|NCT00328627|Secondary|Percentage of Participants With Glycosylated Hemoglobin ≤ 7.0% (Grouped Analysis)|"Clinical response at Week 26 was assessed by the percentage of participants with HbA1c less than or equal to 7%.
This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone."|Week 26|The full analysis set. Patients who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.||percentage of participants|||Number
724003|NCT00328627|Secondary|Change From Baseline in Free Fatty Acids Over Time (Grouped Analysis)|Change from Baseline in free fatty acids (FFA) was assessed at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline free fatty acid as continuous covariates.|Baseline and Weeks 12 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mmol/L||Standard Error|Least Squares Mean
724004|NCT00328627|Secondary|Change From Baseline to Week 26 in Triglyceride Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline triglycerides as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
724005|NCT00328627|Secondary|Change From Baseline to Week 20 in Triglyceride Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline triglycerides as continuous covariates.|Baseline and Week 20|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
724006|NCT00328627|Secondary|Change From Baseline to Week 16 in Triglyceride Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline triglycerides as continuous covariates.|Baseline and Week 16|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
724007|NCT00328627|Secondary|Change From Baseline to Week 12 in Triglyceride Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline triglycerides as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
724008|NCT00328627|Secondary|Change From Baseline to Week 8 in Triglyceride Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline triglycerides as continuous covariates.|Baseline and Week 8|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
724009|NCT00328627|Secondary|Change From Baseline to Week 4 in Triglyceride Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline triglycerides as continuous covariates.|Baseline and Week 4|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
724010|NCT00328627|Secondary|Change From Baseline in Triglycerides Over Time (Grouped Analysis)|Change from Baseline in triglycerides was assessed at Weeks 4, 8, 12, 16, 20 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline triglycerides as continuous covariates.|Baseline and Weeks 4, 8, 12, 16, 20 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
724011|NCT00328627|Secondary|Change From Baseline to Week 26 in High-Density Lipoprotein Cholesterol|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HDL cholesterol as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
724012|NCT00328627|Secondary|Change From Baseline to Week 20 in High-Density Lipoprotein Cholesterol|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HDL cholesterol as continuous covariates.|Baseline and Week 20|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
724013|NCT00328627|Secondary|Change From Baseline to Week 16 in High-Density Lipoprotein Cholesterol|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HDL cholesterol as continuous covariates.|Baseline and Week 16|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
724014|NCT00328627|Secondary|Change From Baseline to Week 12 in High-Density Lipoprotein Cholesterol|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HDL cholesterol as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
724015|NCT00328627|Secondary|Change From Baseline to Week 8 in High-Density Lipoprotein Cholesterol|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HDL cholesterol as continuous covariates.|Baseline and Week 8|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
724016|NCT00328627|Secondary|Change From Baseline to Week 4 in High-Density Lipoprotein Cholesterol|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HDL cholesterol as continuous covariates.|Baseline and Week 4|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
724017|NCT00328627|Secondary|Change From Baseline in High-Density Lipoprotein Cholesterol Over Time (Grouped Analysis)|"Change from Baseline in high-density lipoprotein cholesterol (HDL-C) was assessed at Weeks 4, 8, 12, 16, 20 and 26.
This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HDL cholesterol as continuous covariates."|Baseline and Weeks 4, 8, 12, 16, 20 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
724018|NCT00328627|Secondary|Change From Baseline to Week 26 in Low-Density Lipoprotein Cholesterol|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline LDL cholesterol as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
724019|NCT00328627|Secondary|Change From Baseline to Week 20 in Low-Density Lipoprotein Cholesterol|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline LDL cholesterol as continuous covariates.|Baseline and Week 20|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
724020|NCT00328627|Secondary|Change From Baseline to Week 16 in Low-Density Lipoprotein Cholesterol|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline LDL cholesterol as continuous covariates.|Baseline and Week 16|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
724021|NCT00328627|Secondary|Change From Baseline to Week 12 in Low-Density Lipoprotein Cholesterol|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline LDL cholesterol as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
724022|NCT00328627|Secondary|Change From Baseline to Week 8 in Low-Density Lipoprotein Cholesterol|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline LDL cholesterol as continuous covariates.|Baseline and Week 8|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
724023|NCT00328627|Secondary|Change From Baseline to Week 4 in Low-Density Lipoprotein Cholesterol|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline LDL cholesterol as continuous covariates.|Baseline and Week 4|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
724024|NCT00328627|Secondary|Change From Baseline in Low-Density Lipoprotein Cholesterol Over Time (Grouped Analysis)|"Change from Baseline in low-density lipoprotein cholesterol (LDL-C) was assessed at Weeks 4, 8, 12, 16, 20 and 26.
This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline LDL cholesterol as continuous covariates."|Baseline and Weeks 4, 8, 12, 16, 20 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
724025|NCT00328627|Secondary|Change From Baseline to Week 26 in Total Cholesterol Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline total cholesterol as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
724026|NCT00328627|Secondary|Change From Baseline to Week 20 in Total Cholesterol Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline total cholesterol as continuous covariates.|Baseline and Week 20|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
724027|NCT00328627|Secondary|Change From Baseline to Week 16 in Total Cholesterol Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline total cholesterol as continuous covariates.|Baseline and Week 16|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
724028|NCT00328627|Secondary|Change From Baseline to Week 12 in Total Cholesterol Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline total cholesterol as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
724029|NCT00328627|Secondary|Change From Baseline to Week 8 in Total Cholesterol Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline total cholesterol as continuous covariates.|Baseline and Week 8|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
724030|NCT00328627|Secondary|Change From Baseline to Week 4 in Total Cholesterol Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline total cholesterol as continuous covariates.|Baseline and Week 4|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
724031|NCT00328627|Secondary|Change From Baseline in Total Cholesterol Over Time (Grouped Analysis)|Change from Baseline in total cholesterol was assessed at Weeks 4, 8, 12, 16, 20 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline total cholesterol as continuous covariates.|Baseline and Weeks 4, 8, 12, 16, 20 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
724032|NCT00328627|Secondary|Change From Baseline to Week 26 in C-peptide Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline C-peptide as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||ng/mL||Standard Error|Least Squares Mean
724033|NCT00328627|Secondary|Change From Baseline to Week 20 in C-peptide Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline C-peptide as continuous covariates.|Baseline and Week 20|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||ng/mL||Standard Error|Least Squares Mean
724034|NCT00328627|Secondary|Change From Baseline to Week 16 in C-peptide Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline C-peptide as continuous covariates.|Baseline and Week 16|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||ng/mL||Standard Error|Least Squares Mean
724035|NCT00328627|Secondary|Change From Baseline to Week 12 in C-peptide Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline C-peptide as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||ng/mL||Standard Error|Least Squares Mean
724036|NCT00328627|Secondary|Change From Baseline to Week 8 in C-peptide Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline C-peptide as continuous covariates.|Baseline and Week 8|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||ng/mL||Standard Error|Least Squares Mean
724037|NCT00328627|Secondary|Change From Baseline to Week 4 in C-peptide Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline C-peptide as continuous covariates.|Baseline and Week 4|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||ng/mL||Standard Error|Least Squares Mean
724038|NCT00328627|Secondary|Change From Baseline in C-peptide Over Time (Grouped Analysis)|"C-peptide is a byproduct created when the hormone insulin is produced and is measured by a blood test. Change from Baseline was assessed at Weeks 4, 8, 12, 16, 20 and 26.
This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline C-peptide as continuous covariates."|Baseline and Weeks 4, 8, 12, 16, 20 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||ng/mL||Standard Error|Least Squares Mean
724039|NCT00328627|Secondary|Change From Baseline to Week 26 in Proinsulin/Insulin Ratio|"The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (μIU/mL).
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin/insulin ratio as continuous covariates."|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||ratio||Standard Error|Least Squares Mean
724040|NCT00328627|Secondary|Change From Baseline to Week 20 in Proinsulin/Insulin Ratio|"The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (μIU/mL).
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin/insulin ratio as continuous covariates."|Baseline and Week 20|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||ratio||Standard Error|Least Squares Mean
724041|NCT00328627|Secondary|Change From Baseline to Week 16 in Proinsulin/Insulin Ratio|"The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (μIU/mL).
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin/insulin ratio as continuous covariates."|Baseline and Week 16|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||ratio||Standard Error|Least Squares Mean
724042|NCT00328627|Secondary|Change From Baseline to Week 12 in Proinsulin/Insulin Ratio|"The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (μIU/mL).
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin/insulin ratio as continuous covariates."|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||ratio||Standard Error|Least Squares Mean
724043|NCT00328627|Secondary|Change From Baseline to Week 8 in Proinsulin/Insulin Ratio|"The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (μIU/mL).
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin/insulin ratio as continuous covariates."|Baseline and Week 8|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||ratio||Standard Error|Least Squares Mean
724910|NCT00348790|Secondary|To Determine the Safety of Vatalanib in Patients With Recurrent of Progressive Meningiomas|Safety of vatalanib will be assessed by labs being done weekly|Every week while on study treatment||||||
724045|NCT00328627|Secondary|Change From Baseline in Proinsulin/Insulin Ratio Over Time (Grouped Analysis)|"The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (μIU/mL) at weeks 4, 8, 12, 16, 20 and 26 relative to the Baseline value.
This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin/insulin ratio as continuous covariates."|Baseline and Weeks 4, 8, 12, 16, 20 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||ratio||Standard Error|Least Squares Mean
724046|NCT00328627|Secondary|Change From Baseline to Week 26 in Insulin Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline insulin as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||µIU/mL||Standard Error|Least Squares Mean
724047|NCT00328627|Secondary|Change From Baseline to Week 20 in Insulin Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline insulin as continuous covariates.|Baseline and Week 20|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||µIU/mL||Standard Error|Least Squares Mean
724048|NCT00328627|Secondary|Change From Baseline to Week 16 in Insulin Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline insulin as continuous covariates.|Baseline and Week 16|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||µIU/mL||Standard Error|Least Squares Mean
724049|NCT00328627|Secondary|Change From Baseline to Week 12 in Insulin Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline insulin as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||µIU/mL||Standard Error|Least Squares Mean
724050|NCT00328627|Secondary|Change From Baseline to Week 8 in Insulin Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline insulin as continuous covariates.|Baseline and Week 8|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||µIU/mL||Standard Error|Least Squares Mean
724051|NCT00328627|Secondary|Change From Baseline to Week 4 in Insulin Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline insulin as continuous covariates.|Baseline and Week 4|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||µIU/mL||Standard Error|Least Squares Mean
724052|NCT00328627|Secondary|Change From Baseline in Insulin Over Time (Grouped Analysis)|The change from Baseline in fasting insulin was assessed at Weeks 4, 8, 12, 16, 20 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline insulin as continuous covariates.|Baseline and Weeks 4, 8, 12, 16, 20 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||µIU/mL||Standard Error|Least Squares Mean
724053|NCT00328627|Secondary|Change From Baseline to Week 26 in Fasting Proinsulin|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||pmol/L||Standard Error|Least Squares Mean
724054|NCT00328627|Secondary|Change From Baseline to Week 20 in Fasting Proinsulin|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin as continuous covariates.|Baseline and Week 20|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||pmol/L||Standard Error|Least Squares Mean
724055|NCT00328627|Secondary|Change From Baseline to Week 16 in Fasting Proinsulin|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin as continuous covariates.|Baseline and Week 16|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||pmol/L||Standard Error|Least Squares Mean
724056|NCT00328627|Secondary|Change From Baseline to Week 12 in Fasting Proinsulin|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||pmol/L||Standard Error|Least Squares Mean
724057|NCT00328627|Secondary|Change From Baseline to Week 8 in Fasting Proinsulin|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin as continuous covariates.|Baseline and Week 8|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||pmol/L||Standard Error|Least Squares Mean
724058|NCT00328627|Secondary|Change From Baseline to Week 4 in Fasting Proinsulin|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin as continuous covariates.|Baseline and Week 4|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||pmol/L||Standard Error|Least Squares Mean
724963|NCT00349466|Secondary|Tear Meniscus (TM) Height|Indicator of tear volume. TM was recorded on a scale from 0-3, with 0=none, 1=trace, 2=normal, and 3=high.|12 weeks||||||
724059|NCT00328627|Secondary|Change From Baseline in Fasting Proinsulin Over Time (Grouped Analysis)|"Proinsulin is a precursor to insulin, and was measured as an indicator of pancreatic function. The change from Baseline in fasting proinsulin was assessed at Weeks 4, 8, 12, 16, 20 and 26.
This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and proinsulin as continuous covariates."|Baseline and Weeks 4, 8, 12, 16, 20 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||pmol/L||Standard Error|Least Squares Mean
724060|NCT00328627|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 2%|Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 2%.|Baseline and Week 26|The full analysis set. Patients who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.||percentage of participants|||Number
724061|NCT00328627|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 2.0% (Grouped Analysis)|"Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 2.0%.
This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone."|Baseline and Week 26.|The full analysis set. Patients who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.||percentage of participants|||Number
724062|NCT00328627|Primary|Change From Baseline to Week 26 in HbA1c|The change from Baseline to Week 26 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound).|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
724063|NCT00328627|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 1.5%|Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 1.5%.|Baseline and Week 26|The full analysis set. Patients who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.||percentage of participants|||Number
724064|NCT00328627|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 1.5% (Grouped Analysis)|"Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 1.5%.
This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone."|Baseline and Week 26|The full analysis set. Patients who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.||percentage of participants|||Number
724065|NCT00328627|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 1%|Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 1%.|Baseline and Week 26|The full analysis set. Patients who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.||percentage of participants|||Number
724066|NCT00328627|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 1% (Grouped Analysis)|"Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 1%.
This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone."|Baseline and Week 26|The full analysis set. Patients who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.||percentage of participants|||Number
724067|NCT00328627|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 0.5%|Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 0.5%.|Baseline and Week 26|The full analysis set. Patients who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.||percentage of participants|||Number
724068|NCT00328627|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 0.5% (Grouped Analysis)|"Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 0.5%.
This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone."|Baseline and Week 26|The full analysis set. Patients who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.||percentage of participants|||Number
724069|NCT00328627|Secondary|Percentage of Participants With Glycosylated Hemoglobin ≤ 7.5%|Clinical response at Week 26 was assessed by the percentage of participants with HbA1c less than or equal to 7.5%.|Week 26|The full analysis set. Patients who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.||percentage of participants|||Number
724070|NCT00328627|Secondary|Percentage of Participants With Glycosylated Hemoglobin ≤ 7.5% (Grouped Analysis)|"Clinical response at Week 26 was assessed by the percentage of participants with HbA1c less than or equal to 7.5%.
This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone."|Week 26|The full analysis set. Patients who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.||percentage of participants|||Number
724071|NCT00328627|Secondary|Percentage of Participants With Glycosylated Hemoglobin ≤ 7%|Clinical response at Week 26 was assessed by the percentage of participants with HbA1c less than or equal to 7%.|Week 26|The full analysis set. Patients who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.||percentage of participants|||Number
724964|NCT00349466|Secondary|Dry Eye Symptom Score|consists of 12 questions designed to assess the symptoms of ocular irritations, covering three areas: ocular symptoms, environmental triggers and visionrelated function|12 weeks||||||
724073|NCT00328627|Secondary|Percentage of Participants With Glycosylated Hemoglobin ≤ 6.5%|Clinical response at Week 26 was assessed by the percentage of participants with HbA1c less than or equal to 6.5%.|Week 26|The full analysis set. Patients who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.||percentage of participants|||Number
724074|NCT00328627|Secondary|Percentage of Participants With Glycosylated Hemoglobin ≤ 6.5% (Grouped Analysis)|"Clinical response at Week 26 was assessed by the percentage of participants with HbA1c less than or equal to 6.5%.
This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone."|Week 26|The full analysis set. Patients who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.||percentage of participants|||Number
724075|NCT00328627|Secondary|Percentage of Participants Meeting Rescue Criteria|"Rescue was defined as meeting 1 of the following criteria, confirmed by a 2nd sample drawn within 5 days of the first and analyzed by the central laboratory:
After the Week 1 Visit but prior to the Week 4 Visit: a single fasting plasma glucose ≥300 mg/dL;
From the Week 4 Visit but prior to the Week 8 Visit: a single fasting plasma glucose ≥275 mg/dL;
From the Week 8 Visit but prior to the Week 12 Visit: a single fasting plasma glucose ≥250 mg/dL;
From the Week 12 Visit through the End-of-Treatment Visit: HbA1c ≥8.5% and ≤0.5% reduction in HbA1c as compared with Baseline HbA1c."|From Week 1 to Week 26|Full analysis set including patients with at least 1 postbaseline visit.||percentage of participants|||Number
724076|NCT00328627|Secondary|Percentage of Participants Meeting Rescue Criteria (Grouped Analysis)|"Rescue was defined as meeting 1 of the following criteria, confirmed by a 2nd sample drawn within 5 days of the first and analyzed by the central laboratory:
After the Week 1 Visit but prior to the Week 4 Visit: a single fasting plasma glucose ≥300 mg/dL;
From the Week 4 Visit but prior to the Week 8 Visit: a single fasting plasma glucose ≥275 mg/dL;
From the Week 8 Visit but prior to the Week 12 Visit: a single fasting plasma glucose ≥250 mg/dL;
From the Week 12 Visit through the End-of-Treatment Visit: HbA1c ≥8.5% and ≤0.5% reduction in HbA1c as compared with Baseline HbA1c."|From Week 1 to Week 26.|Full analysis set including patients with at least 1 postbaseline visit. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone.||percentage of participants|||Number
724077|NCT00328627|Secondary|Percentage of Participants With Marked Hyperglycemia|Marked hyperglycemia is defined as fasting plasma glucose greater than or equal to 200 mg/dL (11.10 mmol/L).|From Week 1 to Week 26|Full analysis set including patients with at least one non-missing fasting plasma glucose result in each treatment group.||percentage of participants|||Number
724078|NCT00328627|Secondary|Percentage of Participants With Marked Hyperglycemia (Grouped Analysis)|"Marked hyperglycemia is defined as fasting plasma glucose greater than or equal to 200 mg/dL (11.10 mmol/L).
This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone."|From Week 1 to Week 26|Full analysis set including patients with at least one non-missing fasting plasma glucose result in each treatment group.||percentage of participants|||Number
724079|NCT00328627|Secondary|Change From Baseline to Week 26 in Fasting Plasma Glucose|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
724080|NCT00328627|Secondary|Change From Baseline to Week 20 in Fasting Plasma Glucose|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates.|Baseline and Week 20|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
724081|NCT00328627|Secondary|Change From Baseline to Week 16 in Fasting Plasma Glucose|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates.|Baseline and Week 16|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
724082|NCT00328627|Secondary|Change From Baseline to Week 12 in Fasting Plasma Glucose|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
724083|NCT00328627|Secondary|Change From Baseline to Week 8 in Fasting Plasma Glucose|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates.|Baseline and Week 8|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
724084|NCT00328627|Secondary|Change From Baseline to Week 4 in Fasting Plasma Glucose|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates.|Baseline and Week 4|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
724085|NCT00328627|Secondary|Change From Baseline to Week 2 in Fasting Plasma Glucose|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates.|Baseline and Week 2|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
724086|NCT00328627|Secondary|Change From Baseline to Week 1 in Fasting Plasma Glucose|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates.|Baseline and Week 1|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
724087|NCT00328627|Secondary|Change From Baseline in Fasting Plasma Glucose Over Time (Grouped Analysis)|"The change from Baseline in fasting plasma glucose was assessed at weeks 1, 2, 4, 8, 12, 16, 20 and 26.
This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates."|Baseline and Weeks 1, 2, 4, 8, 12, 16, 20 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
724088|NCT00328627|Secondary|Change From Baseline to Week 20 in HbA1c|"The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at week 20.
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates."|Baseline and Week 20|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
724089|NCT00328627|Secondary|Change From Baseline to Week 16 in HbA1c|The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at week 16. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.|Baseline and Week 16|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward (LOCF) imputation was utilized.||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
724090|NCT00328627|Secondary|Change From Baseline to Week 12 in HbA1c|"The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at week 12.
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates."|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
724091|NCT00328627|Secondary|Change From Baseline to Week 8 in HbA1c|The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at week 8. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.|Baseline and Week 8|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
724092|NCT00328627|Secondary|Change From Baseline to Week 4 in HbA1c|The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at week 4. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.|Baseline and Week 4|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
724093|NCT00328627|Secondary|Change From Baseline in HbA1c Over Time (Grouped Analysis)|"The change from Baseline to Weeks 4, 8, 12, 16 and 20 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound).
This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an analysis of covariance (ANCOVA) model with treatment and geographic region as class variables, and baseline metformin dose and HbA1c as continuous covariates."|Baseline and Weeks 4, 8, 12, 16 and 20.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
724094|NCT00328627|Primary|Change From Baseline to Week 26 in Glycosylated Hemoglobin (HbA1c) (Grouped Analysis)|"The change from Baseline to Week 26 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound).
The primary analysis compared the groupings (combinations of individual treatment groups) of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone (Pioglitazone Alone)."|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
724095|NCT00335257|Primary|Arterial Thromboembolism (ATE), Hazard Ratio for DRSP-24 Day vs. Non-DRSP OCs|Arterial thromboembolism (ATE) in women using oral contraceptives containing both drospirenone (DRSP) and ethinylestradiol (EE) in a 24-day regimen or any oral contraceptive without DRSP. Cox regression analysis was not carried out. In accordance to the analysis plan, hazard ratios were only to be calculated if a minimum of 5 confirmed events were available in each of the comparison groups.|Within 60 months|Study participants that were not excluded due to protocol violation||participants|||Number
724096|NCT00335257|Primary|Venous Thromboembolism (VTE); Hazard Ratio for DRSP-24 Day vs. Non-DRSP OCs|Venous thromboembolism (VTE) hazard ratio for oral contraceptives containing both drospirenone (DRSP) and ethinylestradiol (EE) in a 24-day regimen or any oral contraceptive without DRSP.|Within 60 months|Study participants that were not excluded due to protocol violation||participants|||Number
724097|NCT00335283|Secondary|Quality of Life Questionnaire (QOLRAD)|The patient-reported QOLRAD consists of 25 questions combined into a total score ranging from 25 to 175 with higher numbers representing better quality of life.|Baseline, 8 weeks and 16 weeks|Analysis was performed per the protocol. At the completion of the study, all data were analyzed by the department of statistics and epidemiologyfor the primary outcome of interest, which was response rate for both lansoprazole and placebo. Univariate and multivariate analyses was performed on the collected data.||Scores on a Scale||Inter-Quartile Range|Median
724419|NCT00332696|Secondary|Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 2|Recurrence of bowel obstruction was confirmed by abdominal X-ray.|Month 2|Participants from the Intent-to-treat population (consisting of all randomized participants who received at least one dose of study drug) for whom data was available at Month 2.||Participants|||Number
724098|NCT00335283|Secondary|Sino Nasal Outcome Test (SNOT-20)|SNOT-20 includes 20 questions combined into a total score ranging from 0 to 100 with higher numbers representing greater rhinosinusitis health burden and represents patient-reported symptom severity.|Baseline, 8 weeks and 16 weeks|Analysis was performed per the protocol. At the completion of the study, all data were analyzed by the department of statistics and epidemiologyfor the primary outcome of interest, which was response rate for both lansoprazole and placebo. Univariate and multivariate analyses was performed on the collected data.||Scores on a Scale||Inter-Quartile Range|Median
724099|NCT00335283|Secondary|Rhinosinusitis Outcome Measure(RSOM-31)|RSOM-31 includes 31 questions combined into a total score ranging from 0 to 155 with higher scores representing greater disease burden. Values are based on patient report.|Baseline, 8 weeks, and 16 weeks|Analysis was performed per the protocol. At the completion of the study, all data were analyzed by the department of statistics and epidemiologyfor the primary outcome of interest, which was response rate for both lansoprazole and placebo. Univariate and multivariate analyses was performed on the collected data.||Scores on a Scale||Inter-Quartile Range|Median
724100|NCT00335283|Primary|Post Nasal Drainage Symptom Response|The primary outcome measure was postnasal drainage symptom response measured by using a visual analogue scale. At 8 and 16 weeks, a horizontal symptoms scale from 0% (no change) to 100% (symptoms completely resolved) was presented to participants to assess improvement in postnasal drainage symptoms.|8 and 16 weeks|Analysis was performed per the protocol. At the completion of the study, all data were analyzed by the department of statistics and epidemiologyfor the primary outcome of interest, which was response rate for both lansoprazole and placebo. Univariate and multivariate analyses was performed on the collected data.||Scores on a Scale||Inter-Quartile Range|Median
724101|NCT00335322|Secondary|Compare the Safety of Three Strategic Regimens of Initial ART Containing a Fixed Dose Formulation of Tenofovir and Emtricitabine, With Either Efavirenz or Ritonavir Boosted Atazanavir or Zidovudine Plus Abacavir.||144 weeks||||||
724102|NCT00335322|Primary|Time-weighted Mean Change From Baseline Plasma HIV-RNA.||48 weeks|Modified ITT; all randomised pts who started drug||log copies/mL||95% Confidence Interval|Mean
724103|NCT00335452|Post-Hoc|Occurrence of Stent Thrombosis - Clopidogrel Treatment Regimen Comparison|This includes definite stent thrombosis (confirmed by angiography or evidence of recent thrombus determined at autopsy or by examination of tissue retrieved following thrombectomy) and probable stent thrombosis (unexplained death having occurred after intracoronary stenting or, MI related to acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any obvious cause) after validation by the EAC.|30 days|The analysis is on the intent-to-treat population (ITT) that consists of all patients randomized irrespective of whether they received study medication, underwent a PCI, or otherwise complied with the study protocol.||participants|||Number
724104|NCT00335452|Secondary|Occurrence of Major Bleeding - ASA Dose Level Comparison||30 days|The analysis is on the treated patient population that consists of all patients randomized and having receiving at least one dose of ASA. All patients were included in the treatment group to which they were allocated by the AReS.||participants|||Number
724105|NCT00335452|Primary|First Occurrence of CV Death / MI / Stroke - Clopidogrel Treatment Regimen Comparison in PCI Subgroup||30 days|The intent-to-treat (ITT) analysis is done on the randomized patients who underwent PCI during the study.||participants|||Number
724106|NCT00335452|Primary|First Occurrence of CV Death / MI / Stroke - Interaction Clopidogrel Treatment Regimen and ASA Dose Level||30 days|The analysis is on the intent-to-treat population (ITT) that consists of all patients randomized irrespective of whether they received study medication, underwent a PCI, or otherwise complied with the study protocol.||participants|||Number
724107|NCT00335452|Primary|First Occurrence of CV Death / MI / Stroke - ASA Dose Comparison||30 days|The analysis is on the the ASA treated population that consists of all patients randomized and having receiving at least one dose of ASA. All patients were included in the treatment group to which they were allocated by the AReS.||participants|||Number
724108|NCT00335452|Secondary|Occurrence of Major Bleeding - Clopidogrel Dose Regimen Comparison|Major bleeding is defined as any severe bleeding (associated with any of the following: death, leading to a drop in hemoglobin ≥ 5 g/dl, significant hypotension with the need for inotropic agents, symptomatic intracranial hemorrhage, requirement for surgery or for a transfusion ≥ 4 units of red blood cells or equivalent whole blood) and other major bleeding (significantly disabling bleeding, or intraocular bleeding leading to significant loss of vision or bleeding requiring transfusion of 2-3 units of red blood cells or equivalent whole blood) after validation by the independent EAC.|30 days|The analysis is on the intent-to-treat population (ITT) that consists of all patients randomized irrespective of whether they received study medication, underwent a PCI, or otherwise complied with the study protocol.||participants|||Number
724109|NCT00335452|Primary|First Occurrence of CV Death / MI / Stroke - Clopidogrel Treatment Regimen Comparison|"The primary endpoint is the first occurrence of any of the following events:
Cardiovascular death (any death with a clear cardiovascular or unknown cause),
Myocardial Infarction (diagnosis of new Myocardial Infarction (MI) - nonfatal or fatal)
Stroke (presence of a new focal neurologic deficit thought to be vascular in origin, with signs or symptoms lasting more than 24 hours - nonfatal or fatal)
reported between the randomization and Day 30 (inclusive), and validated by the blinded Event Adjudication Committee (EAC)."|30 days|The analysis is on the intent-to-treat population (ITT) that consists of all patients randomized irrespective of whether they received study medication, underwent a PCI, or otherwise complied with the study protocol.||participants|||Number
724110|NCT00335478|Primary|Number of Participants Who Became Afebrile Within 72 Hours of Starting Daptomycin.|"If after 72 hours of daptomycin treatment, the patient is afebrile and has absolute neutrophil count (ANC) >500 cells/mm^3 for 48 hours with no site of infection, negative cultures, and no clinical indications for therapy, the antibiotic regimen will be discontinued.
Complete Response: Resolution of fever and clinical signs/symptoms of infection.
Partial Response: Resolution of fever without resolution of clinical signs of infection."|Within 72 hours of starting daptomycin|||participants|||Number
724111|NCT00335504|Secondary|Adverse Events.|Defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with participation in a study, whether or not related to that participation. Graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 3.0. Number of adverse events per grade level.|Up to 30 days after completion of study treatment|||adverse events|||Number
724112|NCT00335504|Secondary|Effects on Apoptosis (Caspase-3 Expression).|Tissue is examined by immunohistochemistry for cleaved caspase-3. Measured by biopsy samples obtained from normal-appearing rectal mucosa at baseline and after completion of study treatment. Wilcoxon will be used to assess significant differences between the intervention arms.|Up to 6 months|Patients with assay data from baseline and post-intervention biopsy samples of normal-appearing rectal mucosa.||Percent change of caspase-3||Standard Deviation|Mean
724113|NCT00335504|Secondary|Effects on Proliferation (Ki67 Expression).|Tissue is examined by immunohistochemistry for Ki67. Measured by biopsy samples obtained from normal-appearing rectal mucosa at baseline and after completion of study treatment. Wilcoxon will be used to assess significant differences between the intervention arms.|Up to 6 months|Patients with assay data from baseline and post-intervention biopsy samples of normal-appearing rectal mucosa.||Percent change||Standard Deviation|Mean
724114|NCT00335504|Primary|Percent Change in Number of Rectal Aberrant Cryptic Foci (ACF) as Measured by Magnification Chromoendoscopy|At the Pre-Intervention Evaluation, rectal ACF will be classified with respect to ACF number, crypt number, crypt size, tissue plane, staining intensity, and (optional) lumen shape for each subject. At the Post- Intervention Evaluation, these same parameters will be recorded and incident vs prevalent rectal ACF status will also be recorded. Compare each non-placebo arms versus the placebo arm to screen the three active study agents for possible phase III testing.|6 months|The population used for the analysis is patients having at least 5 rectal ACF and completing both the pre- and post-intervention MCE assessments and using intention to treat principles.||percent change in number of ACF||Standard Deviation|Mean
724115|NCT00335517|Primary|Number of Patients Enrolled and Recieving Injection||0-48 hours postoperatively|||participants|||Number
724116|NCT00335556|Secondary|Frequency of TP53 Mutations||At baseline|The analysis was supplanted by an analysis done as part of the TARGET initiative on NWTS-5 sample as a result no TP53 data was collected on AREN0321.|||||
724117|NCT00335556|Secondary|Number of Patients With INI1 Mutations in Renal and Extrarenal Malignant Rhabdoid Tumor by Fluorescent in Situ Hybridization||At baseline|Eligible patients with reported INI1 mutation data.||Count participants|||Number
724118|NCT00335556|Primary|Toxicity Rate|Percentage of participants with Grade 4 cardiac toxicities, Grade 4 Sinusoidal Obstruction Syndrome (SOS), and treatment-related deaths determined using CTCAE v4.|Up to 4 years|Eligible patients treated after Amendment 3A for arms UH-1, UH-2, and Window/UH-1.||Percentage of patients||95% Confidence Interval|Number
724119|NCT00335556|Primary|Event Free Survival Probability|Event-free survival will be informally compared to that seem for similar patients treated on NWTS-5 (NCT00002610).|4 years|Eligible patients with Stage I focal and diffuse anaplastic Wilms tumor.||Percent Probability 4 Year EFS||95% Confidence Interval|Number
724120|NCT00335556|Primary|Response Rate|Criteria for response assessed by three-dimensional measurement: Complete Response (CR), Disappearance of all index lesions and non‐index lesions. No new lesions; Partial Response (PR), At least a 65% decrease in the sum of the volumes of the index lesions. No new lesions; Response rate (RR) = CR+PR of patients who received window therapy.|Up to 2 months|||Percentage of participants||95% Confidence Interval|Number
724121|NCT00335556|Primary|Long-term Survival of Patients With Stage I-IV Malignant Rhabdoid Tumors|The outcome of these patients will be compared with a fixed outcome based on that seen for similar patients treated with NWTS-5 regimen (NCT00002610).|4 years|Eligible patients with Stage I-IV rhabdoid tumor.||Percentage of 4-year OS||95% Confidence Interval|Number
724122|NCT00335556|Primary|Event-Free Survival of Patients With Diffuse Anaplastic Wilms' Tumor (DAWT)|Compare the outcome of patients treated with alternating CyCE/VDCy chemotherapy (with or without vincristine/irinotecan cycles) to a fixed outcome based on that seen for similar patients treated with NWTS‐5 (NCT00002610).|4 years|Eligible patients with Stage II-IV DAWT.||Percentage of 4-year OS||95% Confidence Interval|Number
724123|NCT00335725|Secondary|Clinical Pregnancy Rate|clinical pregnancy rate defined as the presence of gestation sac and heart beat.|6 weeks after treatment start|patients who started the FSH treatment||percentage of treated patients|||Number
724124|NCT00335725|Primary|Total Number of Oocytes Retrieved|Total number of oocytes retrieved|10 days after stimulation start|patients who started the stimulation with FSH||oocytes||Standard Deviation|Mean
724125|NCT00335777|Primary|Number of Subjects Who Were Pain Free at 2 Hours Post Treatment With Study Drug.|"Number of subjects who were pain free at 2 hours after treatment with study medication when they treated a migraine early (defined as treatment within 1 hour of onset of throbbing pain) compared to the number of subjects who were pain free at 2 hours after treatment with study medication when they treated late (defined as 4 hours after onset of throbbing pain). Pain free is defined as a subject rating of zero on a 4 point pain scale; (0=None, 1=mild, 2= moderate, 3=severe)."|2 hours post treatment with study medication|Per protocol population was used in the efficacy analyses. 22 subjects were included, since they treated a migraine early and another migraine late, as defined in the protocol, with study medication.(Cross-over design)||participants|||Number
724126|NCT00335777|Secondary|Use of Rescue Therapy for Each Attack Treated Per Subject||number subjects using rescue used between 2 and 24 hrs after study drug||||||
724127|NCT00335777|Secondary|Subjects Historical Response to Triptan Therapy and Ergot Therapies||baseline||||||
724128|NCT00335777|Secondary|Pain and Associated Symptoms Assessments as Measured at Pre-dose, 15 Minutes, 30 Minutes, 1 Hour, 1 ½ Hours, 2 Hours, 4 Hours, 8 Hours and 24 Hours Post-dosing for Each Attack Treated Per Subject. Post-dosing Assessments Begin After the Entire 4mg. Dose||baseline, 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 4 hr. 8 hr, 24 hr||||||
724129|NCT00335777|Secondary|Allodynia Assessments as Performed at Pre-dosing, 15 Minutes, 30 Minutes, 1 Hour, 1 ½ Hours, 2 Hours, 4 Hours, 8 Hours and 24 Hours Post-dosing for Each Attack Treated Per Subject. Post-dosing Assessments Begin After the Entire 4mg. Dose Has Been Adminis||baseline, 15 minutes, 30 min., 1 hr., 1.5 hr, 2 hr, 4 hr, 8 hr, 24 hr||||||
724130|NCT00335829|Secondary|Safety and Treatment Toxicity - Cycles 2 and 3|Safety and toxicity assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0) for patients (n=14) who completed 2 or 3 cycles of TACE and bevacizumab therapy|6 months|14 out of the original 26 study participants completed 2 or 3 cycles of TACE and bevacizumab therapy - adverse events associated with these patients for cycles 2 and 3 assessed.||adverse events|Adverse events||Number
724965|NCT00349466|Secondary|Proportion of Clinical Success|improvement of ≥25% over baseline at Week 12 in BUT, superficial punctate keratitis as assessed by FS, or ST|12 weeks||||||
724131|NCT00335829|Secondary|Safety and Treatment Toxicity - Cycle 1 Post-TACE|Safety and toxicity assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0) for 25 who completed the first cycle of TACE and bevacizumab therapy|Cycle 1 post-TACE - 5 weeks|1 out of the initial 26 patients did not complete the first TACE on protocol and was not included in this assessment.||adverse events|Adverse events||Number
724132|NCT00335829|Secondary|Safety and Treatment Toxicity - Cycle 1 Pre-TACE|Safety and toxicity assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0) for all patients (n=26) who received bevacizumab prior to TACE therapy.|Cycle 1 pre-TACE - 2 weeks|||adverse events|Adverse events||Number
724133|NCT00335829|Secondary|Response Rate - Based on Tumor Enhancement|"Efficacy as assessed by radiographic tumor response utilizing the following tumor enhancement criteria:
Complete Response (CR): 100% tumor necrosis of the target lesion(s) upon completion of any of the 3 cycles of TACE therapy Partial Response (PR): Greater than 50% tumor necrosis of target lesion(s) Progressive Disease (PD): Reappearance or increased tumor enhancement greater than 25% in target lesion(s) Stable Disease (SD): Cases that do not meet CR or PR and did not demonstrate evidence of tumor progression.
The overall response rate (ORR = CR + PR) was 60%. Disease control rate (DCR = CR + PR + SD) was 100%."|6 months|||Participants|||Count of Participants
724134|NCT00335829|Secondary|Response Rate - Based on Response Evaluation Criteria in Solid Tumors (RECIST)|"Efficacy as assessed by radiographic tumor response using RECIST criteria at baseline, 3 weeks after TACE, and 4 weeks after completion of final cycle.
Complete Response (CR): Disappearance of all lesions targeted by therapy Partial Response (PR): At least 30% decrease in the sum of longest diameter (LD) of lesions targeted by therapy Progressive Disease (PD): At least 20% increase in sum of LD of lesions targeted by therapy Stable Disease (SD): Neither sufficient shrinkage for PR nor sufficient increase for PD."|6 months|||Participants|||Count of Participants
724135|NCT00335829|Secondary|Overall Survival (OS)|OS assessed via Kaplan-Meier methodology both from initiation of therapy and from the date of diagnosis until death.|1 year|||months||95% Confidence Interval|Median
724136|NCT00335829|Secondary|TTP Rate at 6 Months and 1 Year|Overall TTP assessed via Kaplan-Meier methodology at 6 months and 1 year|6 months and 1 year|||percentage of participants||95% Confidence Interval|Number
724137|NCT00335829|Secondary|Overall TTP|Overall TTP assessed via Kaplan-Meier methodology.|1 year|||months||95% Confidence Interval|Median
724138|NCT00335829|Secondary|TTP of Nontargeted Lesions Within the Liver|TTP of nontargeted lesions assessed via Kaplan-Meier methodology.|1 year|||months||95% Confidence Interval|Median
724139|NCT00335829|Primary|Time to Tumor Progression (TTP) of Targeted Lesions|Time to tumor progression was estimated via Kaplan-Meier methodology using the 23 patients who underwent treatment.|6 months and 1 year|||months|||Number
724140|NCT00335829|Primary|Median Progression-free Survival|This outcome was not assessed. Instead, the primary outcome of time to tumor progression (TTP) of the targeted lesions and secondary outcomes of TTP of nontargeted lesions and overall TTP were assessed and reported.|Time through study completion, an average of 1 year|PFS analysis was not conducted.|||||
724141|NCT00335959|Primary|Pathologic Complete Response|Pathologic complete response rates (pCR) of primary gastric adenocarcinoma when treated with oxaliplatin and capecitabine followed by capecitabine and radiation pre-operatively. On review of the resected gastric specimen and accompanying lymph nodes, pCR is no cancer recognized by the pathologist. Margins are free of tumor.|17-19 weeks|Eligible patients who completed pre-operative therapy were assessed for response.||participants|||Number
724142|NCT00335959|Secondary|Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5= Fatal.|Patients were assessed for adverse events after pre-operative chemotherapy, after pre-operative chemoradiation and within 14 days of surgery.|Eligible patients who received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.||Participants with a given type of AE|||Number
724143|NCT00335972|Primary|Intravenous Morphine Equivalents During Post-anesthesia Care Unit (PACU) After Surgery|intravenous morphine equivalents (mg)|During Post-anesthesia care unit after surgery,an average of 4 hours|||mg||Inter-Quartile Range|Median
724144|NCT00335972|Primary|Visual Analogue Scale (VAS) Pain Score|Using a ruler, the score is determined by measuring the distance on the 10-cm line between the “no pain” anchor and the patient’s mark, providing a range of scores from 0–10. 0 = no pain and 10 = worst|pain score measured at 15, 30, 45, 60, and 90 minutes after extubation|||cm||Standard Deviation|Mean
724145|NCT00335972|Primary|Mean Arterial Pressure||mean arterial pressure at 15, 30, 45, 60, and 90 minutes after extubation|||mmHg||Standard Deviation|Mean
724146|NCT00336232|Primary|Plasma Phylloquinone|Plasma phylloquinone in response to phylloquinone depletion and repletion|2 months|||nmol/L||Standard Deviation|Mean
724147|NCT00336284|Secondary|Patient Initiated Follow-up|Percentage of total patient initiated inqueries that result in ER or office follow-up visits.|12 months|Only participants with at least one follow-up are included in the analyses||percent of patient initiated follow-ups|||Number
724148|NCT00336284|Secondary|Early Detection of Cardiac Events|Detection time relative to onset of cardiac events (atrial fibrillation, ventricular tachycardia, ventricular fibrillation).|12 months|Only participants with at least one follow-up are included in the analyses.||Days||Full Range|Mean
724149|NCT00336284|Primary|Percent of Participants Experiencing Death, Incidence of Stroke, or Event Requiring Surgical Intervention.|Percentage of participants experiencing death, incidence of stroke, or event(s) requiring surgical intervention. Outcome measure time frame is 12 months.|12 months|Safety Event Rate includes events occuring within 12 months of enrollment for participants with at least 1 follow-up.||Percentage of participants|||Number
724150|NCT00336284|Primary|Home Monitoring Effectiveness|Average number of office-based implantable cardioverter defibrillator (ICD) follow-up visits in the Home Monitoring arm vs the Conventional (calendar-based) follow-up arm.|12 months|Only participants who completed at least one follow-up visit are included in the analyses.||In-office ICD follow-up per patient year||Full Range|Mean
725091|NCT00350636|Secondary|Baseline Average Daily Urinary Frequency|Number of daily urinary voids|Baseline|||Number of urinary episodes||Standard Deviation|Mean
724151|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness From 3 to 6 Weeks Among Eyes That Received 2.5mg Bevacizumab at 6 Weeks and Had Within >11% Increase in Change of Central Subfield Thickness From 6 Weeks to 9 Weeks|The 2.5mg bevacizumab treatment group received an injection at both baseline and at 6 weeks. Change in central subfield thickness was categorized according to whether it exceeded 11%, the reliability limit for real change determined in another Diabetic Retinopathy Clinical Research Network study 16. The 2.5mg bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|3 to 9 weeks|||participants|||Number
724152|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness From 3 to 6 Weeks Among Eyes That Received 2.5mg Bevacizumab at 6 Weeks and Had Within ±11% Change of Central Subfield Thickness From 6 Weeks to 9 Weeks|The 2.5mg bevacizumab treatment group received an injection at both baseline and at 6 weeks. Change in central subfield thickness was categorized according to whether it exceeded 11%, the reliability limit for real change determined in another Diabetic Retinopathy Clinical Research Network study 16. The 2.5mg bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|3 to 9 weeks|||participants|||Number
724153|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness From 3 to 6 Weeks Among Eyes That Received 2.5mg Bevacizumab at 6 Weeks and Had a >11% Decrease in Change of Central Subfield Thickness From 6 Weeks to 9 Weeks|The 2.5mg bevacizumab treatment group received an injection at both baseline and at 6 weeks. Change in central subfield thickness was categorized according to whether it exceeded 11%, the reliability limit for real change determined in another Diabetic Retinopathy Clinical Research Network study 16. The 2.5mg bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|3 to 9 weeks|||participants|||Number
724154|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness From 3 to 6 Weeks Among Eyes That Received 1.25mg Bevacizumab at 6 Weeks and Had a >11% Increase in Change of Central Subfield Thickness From 6 Weeks to 9 Weeks|The 1.25mg bevacizumab treatment group received an injection at both baseline and at 6 weeks. Change in central subfield thickness was categorized according to whether it exceeded 11%, the reliability limit for real change determined in another Diabetic Retinopathy Clinical Research Network study 16. The 1.25mg bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|3 to 9 weeks|||participants|||Number
724155|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness From 3 to 6 Weeks Among Eyes That Received 1.25mg Bevacizumab at 6 Weeks and Had Within ±11% Change of Central Subfield Thickness From 6 Weeks to 9 Weeks|The 1.25mg bevacizumab treatment group received an injection at both baseline and at 6 weeks. Change in central subfield thickness was categorized according to whether it exceeded 11%, the reliability limit for real change determined in another Diabetic Retinopathy Clinical Research Network study 16. The 1.25mg bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|3 to 9 weeks|||participants|||Number
724156|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness From 3 to 6 Weeks Among Eyes That Received 1.25mg Bevacizumab at 6 Weeks and Had a >11% Decrease in Change of Central Subfield Thickness From 6 Weeks to 9 Weeks|The 1.25mg bevacizumab treatment group received an injection at both baseline and at 6 weeks. Change in central subfield thickness was categorized according to whether it exceeded 11%, the reliability limit for real change determined in another Diabetic Retinopathy Clinical Research Network study 16. The 1.25mg bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|3 to 9 weeks|||participants|||Number
724157|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness From 3 to 6 Weeks Among Eyes That Received 2.5mg Bevacizumab and Had a >11% Increase in Change of Central Subfield Thickness From Baseline to 3 Weeks|The 2.5mg bevacizumab treatment group received an injection at both baseline and at 6 weeks. Change in central subfield thickness was categorized according to whether it exceeded 11%, the reliability limit for real change determined in another Diabetic Retinopathy Clinical Research Network study 16. The 2.5mg bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|3 to 6 Weeks|There were no participants with a change in central subfield thickness from 3 to 6 weeks in this treatment group that had a >11% increase in change of central subfield thickness from baseline to 3 weeks.|||||
724158|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness From 3 to 6 Weeks Among Eyes That Received 2.5mg Bevacizumab and Had Within a ±11% Change in Central Subfield Thickness From Baseline to 3 Weeks|The 2.5mg bevacizumab treatment group received an injection at both baseline and at 6 weeks. Change in central subfield thickness was categorized according to whether it exceeded 11%, the reliability limit for real change determined in another Diabetic Retinopathy Clinical Research Network study 16. The 2.5mg bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|3 to 6 Weeks|||participants|||Number
724159|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness From 3 to 6 Weeks Among Eyes That Received 2.5mg Bevacizumab and Had a >11% Decrease in Change of Central Subfield Thickness From Baseline to 3 Weeks|The 2.5mg bevacizumab treatment group received an injection at both baseline and at 6 weeks. Change in central subfield thickness was categorized according to whether it exceeded 11%, the reliability limit for real change determined in another Diabetic Retinopathy Clinical Research Network study 16. The 2.5mg bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|3 to 6 Weeks|||Participants|||Number
724160|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness From 3 to 6 Weeks Among Eyes That Received 1.25mg Injection Only and Had a >11% Increase in Change of Central Subfield Thickness From Baseline to 3 Weeks|The 1.25mg bevacizumab groups include the following treatment groups: 1.25mg at baseline and 6 weeks; and 1.25mg at baseline only. Change in central subfield thickness was categorized according to whether it exceeded 11%, the reliability limit for real change determined in another Diabetic Retinopathy Clinical Research Network study 16. The pooled 1.25mg bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|3 to 6 Weeks|||Participants|||Number
725092|NCT00350636|Primary|Baseline Average Number of Daily Incontinence Episodes|Average number of daily incontinence episodes at baseline|Baseline|||Number of episodes||Standard Deviation|Mean
724161|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness From 3 to 6 Weeks Among Eyes That Received 1.25mg Injection Only and Had Within a ±11% Change of Central Subfield Thickness From Baseline to 3 Weeks|The 1.25mg bevacizumab groups include the following treatment groups: 1.25mg at baseline and 6 weeks; and 1.25mg at baseline only. Change in central subfield thickness was categorized according to whether it exceeded 11%, the reliability limit for real change determined in another Diabetic Retinopathy Clinical Research Network study 16. The pooled 1.25mg bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|3 to 6 Weeks|||participants|||Number
724162|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness From 3 to 6 Weeks Among Eyes That Received 1.25mg Injection Only and Had a >11% Decrease in Change of Central Subfield Thickness From Baseline to 3 Weeks|The 1.25mg Bevacizumab groups include the following treatment groups: 1.25mg at baseline and 6 weeks; and 1.25mg at baseline only. Duration of effect of Bevacizumab was based on additional improvement versus maintained improvement versus worsening within 3 to 6 weeks. Change in central subfield thickness was categorized according to whether it exceeded 11%, the reliability limit for real change determined in the DRCR.net paper, Reproducibility of macular thickness and volume using Zeiss optical coherence tomography in patients with diabetic macular edema.Ophthalmology 2007;114:1520-25.|3 to 6 Weeks|||Participants|||Number
724163|NCT00336323|Other Pre-specified|Change in Visual Acuity (Letters) in Bevacizumab Groups From Baseline to 3 Weeks According to Subretinal Fluid Presence at Baseline|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks, 2.5mg at baseline and at 6 weeks, 1.25mg at baseline only, and 1.25mg at baseline and 6 weeks plus laser at 3 weeks. The 4 bevacizumab groups (N=87) were pooled to compare differences in response at 3 weeks among subgroups of interest. The pooled Bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure. Positive values represent an improvement in letter score.|baseline to 3 Weeks|||letters||Inter-Quartile Range|Median
724164|NCT00336323|Other Pre-specified|Change in Visual Acuity (Letters) in Bevacizumab Groups From Baseline to 3 Weeks According to Clinical Diabetic Macular Edema Characterization at Baseline|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks, 2.5mg at baseline and at 6 weeks, 1.25mg at baseline only, and 1.25mg at baseline and 6 weeks plus laser at 3 weeks. The 4 bevacizumab groups (N=87) were pooled to compare differences in response at 3 weeks among subgroups of interest. The pooled Bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure. Positive values represent an improvement in letter score.|baseline to 3 Weeks|||letters||Inter-Quartile Range|Median
724165|NCT00336323|Other Pre-specified|Change in Visual Acuity (Letters) in Bevacizumab Groups From Baseline to 3 Weeks According to Retinopathy Severity at Baseline|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks, 2.5mg at baseline and at 6 weeks, 1.25mg at baseline only, and 1.25mg at baseline and 6 weeks plus laser at 3 weeks. The 4 bevacizumab groups (N=87) were pooled to compare differences in response at 3 weeks among subgroups of interest. The pooled Bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure. Positive values represent an improvement in letter score.|baseline to 3 Weeks|||letters||Inter-Quartile Range|Median
724166|NCT00336323|Other Pre-specified|Change in Visual Acuity (Letters) in Bevacizumab Groups From Baseline to 3 Weeks According to History of Treatment for Diabetic Macular Edema|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks, 2.5mg at baseline and at 6 weeks, 1.25mg at baseline only, and 1.25mg at baseline and 6 weeks plus laser at 3 weeks. The 4 bevacizumab groups (N=87) were pooled to compare differences in response at 3 weeks among subgroups of interest. The pooled Bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure. Positive values represent an improvement in letter score.|baseline to 3 Weeks|||letters||Inter-Quartile Range|Median
724167|NCT00336323|Other Pre-specified|Change in Visual Acuity (Letters) in Bevacizumab Groups From Baseline to 3 Weeks According to Gender|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks, 2.5mg at baseline and at 6 weeks, 1.25mg at baseline only, and 1.25mg at baseline and 6 weeks plus laser at 3 weeks. The 4 bevacizumab groups (N=87) were pooled to compare differences in response at 3 weeks among subgroups of interest. The pooled Bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure. Positive values represent an improvement in letter score.|baseline to 3 Weeks|||letters||Inter-Quartile Range|Median
724168|NCT00336323|Other Pre-specified|Change in Visual Acuity (Letters) in Bevacizumab Groups From Baseline to 3 Weeks According to Age at Baseline|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks, 2.5mg at baseline and at 6 weeks, 1.25mg at baseline only, and 1.25mg at baseline and 6 weeks plus laser at 3 weeks. The 4 bevacizumab groups (N=87) were pooled to compare differences in response at 3 weeks among subgroups of interest. The pooled Bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure. Positive values represent an improvement in letter score.|baseline to 3 Weeks|||letters||Inter-Quartile Range|Median
724169|NCT00336323|Other Pre-specified|Change in Visual Acuity (Letters) in Bevacizumab Groups From Baseline to 3 Weeks According to Visual Acuity at Baseline|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks, 2.5mg at baseline and at 6 weeks, 1.25mg at baseline only, and 1.25mg at baseline and 6 weeks plus laser at 3 weeks. The 4 bevacizumab groups (N=87) were pooled to compare differences in response at 3 weeks among subgroups of interest. The pooled Bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure. Positive values represent an improvement in letter score.|baseline to 3 Weeks|||letters||Inter-Quartile Range|Median
724190|NCT00336505|Secondary|Bacteriologic Cures in the Per Protocol Clinically Evaluable Population|All bacteriologically evaluable subjects (ie., the subject had at least one, protocol-defined evaluable pathogen) who demonstrated eradication of all evaluable pathogens (S. pneumoniae, S. aureus, H. influenzae, M. catarrhalis, M. pneumoniae, C. pneumoniae, L. pneumophila).|Test of Cure Visit, defined as 14-22 days after the first dose of study drug.|Includes all Per Protocol Clinically Evaluable subjects that were bacteriologically evaluable (ie., subjects with at least 1 evaluable pathogen) who showed eradication of all evaluable pathogens.||Participants|||Number
724170|NCT00336323|Other Pre-specified|Change in Visual Acuity (Letters) in Bevacizumab Groups From Baseline to 3 Weeks According to Central Subfield Thickness at Baseline|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks, 2.5mg at baseline and at 6 weeks, 1.25mg at baseline only, and 1.25mg at baseline and 6 weeks plus laser at 3 weeks. The 4 bevacizumab groups (N=87) were pooled to compare differences in response at 3 weeks among subgroups of interest. The pooled Bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure. Positive values represent an improvement in letter score.|baseline to 3 Weeks|||letters||Inter-Quartile Range|Median
724171|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness in Bevacizumab Groups From Baseline to 3 Weeks According to Subretinal Fluid Presence at Baseline|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks, 2.5mg at baseline and at 6 weeks, 1.25mg at baseline only, and 1.25mg at baseline and 6 weeks plus laser at 3 weeks. Negative values represent a reduction in central subfield thickness. The 4 bevacizumab groups (N=87) were pooled to compare differences in response at 3 weeks among subgroups of interest. The pooled Bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|baseline to 3 Weeks|||microns||Inter-Quartile Range|Median
724172|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness in Bevacizumab Groups From Baseline to 3 Weeks According to Clinical Diabetic Macular Edema Characterization at Baseline|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks, 2.5mg at baseline and at 6 weeks, 1.25mg at baseline only, and 1.25mg at baseline and 6 weeks plus laser at 3 weeks. Negative values represent a reduction in central subfield thickness. The 4 bevacizumab groups (N=87) were pooled to compare differences in response at 3 weeks among subgroups of interest. The pooled Bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|baseline to 3 Weeks|||microns||Inter-Quartile Range|Median
724173|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness in Bevacizumab Groups From Baseline to 3 Weeks According to Retinopathy Severity at Baseline|Pooled Bevacizumab group includes treatment groups: 1.25mg at baseline and at 6 weeks, 2.5mg at baseline and at 6 weeks, 1.25mg at baseline only, and 1.25mg at baseline and 6 weeks + laser at 3 weeks. Negative values represent a reduction in central subfield thickness. The 4 bevacizumab groups (N=87) were pooled to compare differences in response at 3 weeks among subgroups of interest. Retinopathy severity based on investigator discretion on clinical examination.|baseline to 3 Weeks|||microns||Inter-Quartile Range|Median
724174|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness in Bevacizumab Groups From Baseline to 3 Weeks According to History of Treatment for Diabetic Macular Edema at Baseline|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks, 2.5mg at baseline and at 6 weeks, 1.25mg at baseline only, and 1.25mg at baseline and 6 weeks plus laser at 3 weeks. Negative values represent a reduction in central subfield thickness. The 4 bevacizumab groups (N=87) were pooled to compare differences in response at 3 weeks among subgroups of interest. The pooled Bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|Baseline to 3 Weeks|||microns||Inter-Quartile Range|Median
724175|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness in Bevacizumab Groups From Baseline to 3 Weeks According to Gender|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks, 2.5mg at baseline and at 6 weeks, 1.25mg at baseline only, and 1.25mg at baseline and 6 weeks plus laser at 3 weeks. Negative values represent a reduction in central subfield thickness. The 4 bevacizumab groups (N=87) were pooled to compare differences in response at 3 weeks among subgroups of interest. The pooled Bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|Baseline to 3 Weeks|||microns||Inter-Quartile Range|Median
724176|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness in Bevacizumab Groups From Baseline to 3 Weeks According to Age at Baseline|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks, 2.5mg at baseline and at 6 weeks, 1.25mg at baseline only, and 1.25mg at baseline and 6 weeks plus laser at 3 weeks. Negative values represent a reduction in central subfield thickness. The 4 bevacizumab groups (N=87) were pooled to compare differences in response at 3 weeks among subgroups of interest. The pooled Bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|Baseline to 3 Weeks|||microns||Inter-Quartile Range|Median
724177|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness in Bevacizumab Groups From Baseline to 3 Weeks According to Baseline Visual Acuity Letter Score|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks, 2.5mg at baseline and at 6 weeks, 1.25mg at baseline only, and 1.25mg at baseline and 6 weeks plus laser at 3 weeks. Negative values represent a reduction in central subfield thickness. The 4 bevacizumab groups (N=87) were pooled to compare differences in response at 3 weeks among subgroups of interest. The pooled Bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|Baseline to 3 Weeks|||microns||Inter-Quartile Range|Median
724178|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness in Bevacizumab Groups From Baseline to 3 Weeks According to Baseline Central Subfield Thickness|Pooled Bevacizumab groups include the following treatment groups: 1.25mg at baseline and at 6 weeks, 2.5mg at baseline and at 6 weeks, 1.25mg at baseline only, and 1.25mg at baseline and 6 weeks plus laser at 3 weeks. Negative values represent a reduction in central subfield thickness. The 4 bevacizumab groups (N=87) were pooled to compare differences in response at 3 weeks among subgroups of interest. The pooled Bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|Baseline to 3 Weeks|||microns||Inter-Quartile Range|Median
724179|NCT00336323|Secondary|Distribution of Change in Visual Acuity Over All Study Visits|Visual acuity letter score as measured using an electronic visual acuity testing machine based on the electronic Early Treatment for Diabetic Retinopathy Study(E-ETDRS) technique. At baseline and at each follow up visit, best corrected visual acuity was measured at 3 meters by a certified tester using an electronic procedure based on the E-ETDRS method. Letter score best value = 97 and worst value = 0; an increase in a letter score by 10 is considered clinically significant.|Baseline to 3,6,9, and 12 weeks|||participants|||Number
724180|NCT00336323|Primary|Percentage of Participants With <250 Microns or ≥ 50% Reduction in Retinal Thickening From Baseline Over All Study Visits|Central subfield retinal thickness measured on Optical Coherence Tomography (OCT). OCT images were obtained at each visit following pupil dilation by a certified operator using the OCT3 machine (Carl Zeiss Meditec Inc., Dublin, CA). Scans were 6 mm length and included the 6 radial line pattern for quantitative measures and the cross hair pattern (6-12 to 9-3 o'clock) for qualitative assessment of retinal morphology. The OCT scans were sent to the DRCR.net Reading Center for grading.|Baseline to 3,6,9, and 12 Weeks|The primary analysis included per protocol and intent to treat analysis. The intent to treat analysis included all randomized eyes. The last observation carried forward method was used to impute missing data. The per-protocol analysis was performed including only patients who receive treatment as per the protocol and complete the 9-week exam.||percentage of participants|||Number
724181|NCT00336323|Secondary|Change in Visual Acuity Letter Score From Baseline Over All All Study Visits|Change in visual acuity letter score as measured using an electronic visual acuity testing machine based on the electronic Early Treatment for Diabetic Retinopathy Study(E-ETDRS) technique. At baseline and at each follow up visit, best corrected visual acuity was measured at 3 meters by a certified tester using an electronic procedure based on the E-ETDRS method. Letter score best value = 97 and worst value = 0; positive change represents an improvement in letter score.|Baseline to 3,6,9, and 12 weeks|||letters||Inter-Quartile Range|Median
724182|NCT00336323|Primary|Change in Central Subfield Retinal Thickness From Baseline Over All Study Visits|Change in central subfield retinal thickness from baseline measured on Optical Coherence Tomography (OCT). OCT images were obtained at each visit following pupil dilation by a certified operator using the OCT3 machine (Carl Zeiss Meditec Inc., Dublin, CA). Scans were 6 mm length and included the 6 radial line pattern for quantitative measures and the cross hair pattern (6-12 to 9-3 o'clock) for qualitative assessment of retinal morphology. The OCT scans were sent to the DRCR.net Reading Center for grading. Negative changes represent a decrease in retinal thickening.|Baseline to 3,6,9, and 12 weeks|The primary analysis included per protocol and intent to treat analysis. The intent to treat analysis included all randomized eyes. The last observation carried forward method was used to impute missing data. The per-protocol analysis was performed including only patients who receive treatment as per the protocol and complete the 9-week exam.||microns||Inter-Quartile Range|Median
724183|NCT00336479|Secondary|Maximum (Cmax), Minimum (Cmin) and Average (Cavg) Plasma Concentration of Telaprevir|Only subjects who received telaprevir were to be analyzed for this outcome. Maximum, minimum and average plasma concentrations observed during assessment period were reported.|Day 1, 4, 8, 15, 22, 29, 43, 57, 71, 85|Pharmacokinetic population included all subjects who provided pharmacokinetic assessments and had evaluable and interpretable data.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
724184|NCT00336479|Secondary|Number of Subjects With Viral Relapse|Viral relapse was defined as having detectable HCV RNA during antiviral follow-up. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).|After last dose of study drug up to antiviral follow-up (up to Week 72)|Analysis population included subjects who completed their assigned study drug treatment and had undetectable HCV RNA at the completion of treatment (up to Week 48).||participants|||Number
724185|NCT00336479|Secondary|Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: any adverse change from the subject’s baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. “Study drug” includes all investigational agents (including placebo, if applicable) administered during the course of the study.|Baseline up to Week 48|The Full Analysis set included all randomized subjects who received at least 1 dose of study drug.||participants|||Number
724186|NCT00336479|Secondary|Percentage of Subjects With Undetectable Plasma HCV RNA at Week 12 After the Completion of Study Drug Dosing|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).|12 weeks after the completion of study drug dosing (up to Week 60)|The Full Analysis set included all randomized subjects who received at least 1 dose of study drug.||percentage of participants|||Number
724187|NCT00336479|Primary|Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Study Drug Dosing|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).|24 weeks after the completion of study drug dosing (up to Week 72)|The Full Analysis set included all randomized subjects who received at least 1 dose of study drug.||percentage of participants|||Number
724188|NCT00336492|Secondary|The Number of Participants With Pediatric Ulcerative Colitis Activity Index (PUCAI) Remission at Week 54|Range is 0 to 85 points, where 0 is the least disease activity, and 85 is the most disease activity. Remission is a score <10. In addition to the PUCAI remission status, treatment failure rules (patients who discontinued study agent due to lack of therapeutic effect, had a colectomy or ostomy, had protocol-prohibited medication changes, or stepped up) were applied to determine the final PUCAI.|Week 54|PUCAI remission at Week 54 analysis was based on all participants randomized at Week 8 who were evaluable for PUCAI. Fifteen participants discontinued Infliximab treatment.||Participants|||Number
724189|NCT00336492|Primary|The Number of Participants With Clinical Response at Week 8|Range is 0 to 12 points, where 0 is the least disease activity, and 12 is the most disease activity. Clinical response at Week 8 is defined as a decrease from baseline in the Mayo score(based on symptoms of ulcerative colitis) by >=30% and >= 3 points, with a decrease in the rectal bleeding subscore >=1 or a rectal bleeding subscore of 0 or 1. Treatment failure rules (patients who discontinued study agent due to lack of therapeutic effect, had a colectomy or ostomy, or had protocol-prohibited medication changes) were applied to determine the final clinical response status for each patient.|Week 8|The primary efficacy endpoint analysis was based on all treated participants.||Participants|||Number
724204|NCT00336700|Primary|1-year Recurrence Free Survival (RFS)||Up to 60 months|||percentage of participants||95% Confidence Interval|Number
724191|NCT00336505|Primary|Clinical Cures in the Per Protocol Clinically Evaluable Population|Investigators evaluated subjects for a clinical response of cure, failure, or indeterminate. Cure: Improvement or return to preinfection state or lack of progression of all pulmonary infiltrates, and resolution of all signs/symptoms present at enrollment. Failure: Persistence or worsening of signs/symptoms, the need for additional antibiotic, new pulmonary infection, progression of the chest radiograph, or death due to pneumonia. Indeterminate: Evaluation was not possible (lost to follow up, adverse event, major protocol violation). Indeterminates default to failure for analysis.|Test of Cure Visit, defined as 14-22 days after the first dose of study drug|The Per Protocol Clinically Evaluable Population included all ITT subjects who took the protocol-defined minimum therapy duration, were dosed with no other antimicrobials (unless allowed by protocol), and had no other major protocol violations||Participants|||Number
724192|NCT00336505|Secondary|Bacteriologic Cures in the Intent to Treat Population|All bacteriologically evaluable subjects (ie., the subject had at least one, protocol-defined evaluable pathogen) who demonstrated eradication of all evaluable pathogens (S. pneumoniae, S. aureus, H. influenzae, M. catarrhalis, M. pneumoniae, C. pneumoniae, L. pneumophila).|Test of Cure Visit, defined as 14-22 days after the first dose of study drug.|Includes all Intent to Treat subjects that were bacteriologically evaluable (ie., subjects with at least 1 evaluable pathogen) who showed eradication of all evaluable pathogens.||Participants|||Number
724193|NCT00336505|Primary|Clinical Cures in the Intent to Treat Population|Investigators evaluated subjects for a clinical response of cure, failure, or indeterminate. Cure: Improvement or return to preinfection state or lack of progression of all pulmonary infiltrates, and resolution of all signs/symptoms present at enrollment. Failure: Persistence or worsening of signs/symptoms, the need for additional antibiotic, new pulmonary infection, progression of the chest radiograph, or death due to pneumonia. Indeterminate: Evaluation was not possible (lost to follow up, adverse event, major protocol violation). Indeterminates default to failure for analysis.|Test of Cure Visit, defined as 14-22 days after the first dose of study drug.|The Intent to Treat Population is defined as all subjects with a confirmed diagnosis of community acquired pneumonia who took at least one dose of study medication. Subjects without a radiologist-confirmed chest X-ray for pneumonia were not included in the efficacy populations.||Participants|||Number
724194|NCT00336544|Secondary|Bacteriologic Cures in the Per Protocol Clinically Evaluable Population|All bacteriologically evaluable subjects (ie., the subject had at least one, protocol-defined evaluable pathogen) who demonstrated eradication of all evaluable pathogens (S. pneumoniae, S. aureus, H. influenzae, M. catarrhalis, M. pneumoniae, C. pneumoniae, L. pneumophila).|Test of Cure Visit, defined as 14-22 days after the first dose of study|Includes all Per Protocol Clinically Evaluable subjects that were bacteriologically evaluable (ie., subjects with at least 1 evaluable pathogen) who showed eradication of all evaluable pathogens.||Participants|||Number
724195|NCT00336544|Primary|Clinical Cures in the Per Protocol Clinically Evaluable Population|Investigators evaluated subjects for a clinical response of cure, failure, or indeterminate. Cure: Improvement or return to preinfection state or lack of progression of all pulmonary infiltrates, and resolution of all signs/symptoms present at enrollment. Failure: Persistence or worsening of signs/symptoms, the need for additional antibiotic, new pulmonary infection, progression of the chest radiograph, or death due to pneumonia. Indeterminate: Evaluation was not possible (lost to follow up, adverse event, major protocol violation). Indeterminates default to failure for analysis.|Test of Cure Visit, defined as 14-22 days after the first dose of study|The Per Protocol Clinically Evaluable Population included all ITT subjects who took the protocol-defined minimum therapy duration, were dosed with no other antimicrobials (unless allowed by protocol), and had no other major protocol violations||Participants|||Number
724196|NCT00336544|Secondary|Bacteriologic Cures in the Intent to Treat Population|All bacteriologically evaluable subjects (ie., the subject had at least one, protocol-defined evaluable pathogen) who demonstrated eradication of all evaluable pathogens (S. pneumoniae, S. aureus, H. influenzae, M. catarrhalis, M. pneumoniae, C. pneumoniae, L. pneumophila).|Test of Cure Visit, defined as 14-22 days after the first dose of study|Includes all Intent to Treat subjects that were bacteriologically evaluable (ie., subjects with at least 1 evaluable pathogen) who showed eradication of all evaluable pathogens.||Participants|||Number
724197|NCT00336544|Primary|Clinical Cures in the Intent to Treat Population|Investigators evaluated subjects for a clinical response of cure, failure, or indeterminate. Cure: Improvement or return to preinfection state or lack of progression of all pulmonary infiltrates, and resolution of all signs/symptoms present at enrollment. Failure: Persistence or worsening of signs/symptoms, the need for additional antibiotic, new pulmonary infection, progression of the chest radiograph, or death due to pneumonia. Indeterminate: Evaluation was not possible (lost to follow up, adverse event, major protocol violation). Indeterminates default to failure for analysis.|Test of Cure Visit, defined as 14-22 days after the first dose of study|The Intent to Treat Population is defined as all subjects with a confirmed diagnosis of community acquired pneumonia who took at least one dose of study medication. Subjects without a radiologist-confirmed chest X-ray for pneumonia were not included in the efficacy populations.||Participants|||Number
724198|NCT00336583|Secondary|Worst Toxicity Grade by Patient|graded by National Cancer Institute Common Toxicity Criteria of Adeverse Event version 3.0|up to 24 weeks|||participants|||Number
724199|NCT00336583|Primary|Overall Response Rate|The Overall Response Rate is measured by the number of patients per the total treatment population who partially or completely responded to treatment. Response will be evaluated according to the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas.|up to 24 weeks|25 patients who had complete at least 3 cycles of ESHAOx study treatment were analyzed. 2 patients who did not completed 3 cylces of study treatment were excluded from the response analysis.||pariticipants|||Number
724200|NCT00336700|Secondary|KRAS Mutational Status|KRAS mutation status in resected tumor specimens.|Up to 60 months|||percentage of participants|||Number
724201|NCT00336700|Secondary|Percentage of Participants With Expression of Epidermal Growth Factor Receptor (EGFR)|Percentage of participants with expression of epidermal growth factor receptor (EGFR) expression in the resected tumors was assessed by fluorescence in situ hybridization (FISH) and immunohistochemistry (IHC).|Up to 60 months|||percentage of participants|||Number
724202|NCT00336700|Secondary|Estimated 1&2 Year Overall Survival (OS)|Time from from date of first study therapy to to death from any cause.|Up to 60 months|||percentage of participants||95% Confidence Interval|Number
724203|NCT00336700|Primary|2-year Recurrence Free Survival (RFS)||Up to 60 months|||percentage of participants||95% Confidence Interval|Number
724213|NCT00336817|Primary|GI Side Effects as Assessed by Gastro Intestinal Symptoms Rating Scale (GSRS) of Enteric-coated Mycophenolate Sodium vs Mycophenolate Mofetil ( Constipation Subscale)|"The GSRS contains 15 items, each rated on a seven-point Likert scale from no discomfort to very severe discomfort. Based on a factor analysis, the 15 GSRS items break down into the following five scale: abdominal pain syndrome ( abdominal pain, hunger pains, and nausea); reflux syndrome (heartburn and acid regurgitation), diarrhea syndrome (diarrhea, loose stools and urgent need for defecation), indigestion syndrome (borborygmus, abdominal distension, eructation and increased flatus) and constipation syndrome (constipation, hard stools, and feeling of incomplete evacuation).
The GSRS is a disease-specific instrument of 15 items combined into five symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhea, and Constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms.
Constipation subscale range is 3 to 21 with higher scores means worst symptoms"|screening, 2, 6 and 12 weeks|||units on a scale||Standard Deviation|Mean
724214|NCT00336817|Primary|GI Side Effects as Assessed by Gastro Intestinal Symptoms Rating Scale (GSRS) of Enteric-coated Mycophenolate Sodium vs Mycophenolate Mofetil ( Diarrhea Subscale)|"The GSRS contains 15 items, each rated on a seven-point Likert scale from no discomfort to very severe discomfort. Based on a factor analysis, the 15 GSRS items break down into the following five scale: abdominal pain syndrome ( abdominal pain, hunger pains, and nausea); reflux syndrome (heartburn and acid regurgitation), diarrhea syndrome (diarrhea, loose stools and urgent need for defecation), indigestion syndrome (borborygmus, abdominal distension, eructation and increased flatus) and constipation syndrome (constipation, hard stools, and feeling of incomplete evacuation).
The GSRS is a disease-specific instrument of 15 items combined into five symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhea, and Constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms.
The Diarrhea subscale range is 3 to 21 with higher scores means worst symptoms"|screening, 2, 6 and 12 weeks|||units on a scale||Standard Deviation|Mean
724215|NCT00336817|Primary|GI Side Effects as Assessed by Gastro Intestinal Symptoms Rating Scale (GSRS) of Enteric-coated Mycophenolate Sodium vs Mycophenolate Mofetil ( Indigestion Subscale)|"The GSRS contains 15 items, each rated on a seven-point Likert scale from no discomfort to very severe discomfort. Based on a factor analysis, the 15 GSRS items break down into the following five scale: abdominal pain syndrome ( abdominal pain, hunger pains, and nausea); reflux syndrome (heartburn and acid regurgitation), diarrhea syndrome (diarrhea, loose stools and urgent need for defecation), indigestion syndrome (borborygmus, abdominal distension, eructation and increased flatus) and constipation syndrome (constipation, hard stools, and feeling of incomplete evacuation).
The GSRS is a disease-specific instrument of 15 items combined into five symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhea, and Constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms.
The Indigestion subscale range is 4 to 28 with higher scores means worst symptoms"|screening, 2, 6 and 12 weeks|||units on a scale||Standard Deviation|Mean
724216|NCT00336817|Primary|GI Side Effects as Assessed by Gastro Intestinal Symptoms Rating Scale (GSRS) of Enteric-coated Mycophenolate Sodium vs Mycophenolate Mofetil (Reflux Subscale)|"The GSRS contains 15 items, each rated on a seven-point Likert scale from no discomfort to very severe discomfort. Based on a factor analysis, the 15 GSRS items break down into the following five scale: abdominal pain syndrome ( abdominal pain, hunger pains, and nausea); reflux syndrome (heartburn and acid regurgitation), diarrhea syndrome (diarrhea, loose stools and urgent need for defecation), indigestion syndrome (borborygmus, abdominal distension, eructation and increased flatus) and constipation syndrome (constipation, hard stools, and feeling of incomplete evacuation).
The GSRS is a disease-specific instrument of 15 items combined into five symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhea, and Constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms.
Reflux subscale range is 2 to 14 with higher scores means worst symptoms"|screening, 2, 6 and 12 weeks|||units on a scale||Standard Deviation|Mean
724217|NCT00336817|Primary|GI Side Effects as Assessed by Gastro Intestinal Symptoms Rating Scale (GSRS) of Enteric-coated Mycophenolate Sodium vs Mycophenolate Mofetil (Abdominal Pain Subscale)|"The GSRS contains 15 items, each rated on a seven-point Likert scale from no discomfort to very severe discomfort. Based on a factor analysis, the 15 GSRS items break down into the following five scale: abdominal pain syndrome ( abdominal pain, hunger pains, and nausea); reflux syndrome (heartburn and acid regurgitation), diarrhea syndrome (diarrhea, loose stools and urgent need for defecation), indigestion syndrome (borborygmus, abdominal distension, eructation and increased flatus) and constipation syndrome (constipation, hard stools, and feeling of incomplete evacuation).
The GSRS is a disease-specific instrument of 15 items combined into five symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhea, and Constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms.
The abdominal Pain subscale range is 3 to 21 with higher scores means worst symptoms"|screening, 2, 6 and 12 weeks|||units on a scale||Standard Deviation|Mean
724218|NCT00336817|Primary|GI Side Effects as Assessed by Gastro Intestinal Symptoms Rating Scale (GSRS) of Enteric-coated Mycophenolate Sodium vs Mycophenolate Mofetil|"The GSRS contains 15 items, each rated on a seven-point Likert scale from no discomfort to very severe discomfort. Based on a factor analysis, the 15 GSRS items break down into the following five scale: abdominal pain syndrome ( abdominal pain, hunger pains, and nausea); reflux syndrome (heartburn and acid regurgitation), diarrhea syndrome (diarrhea, loose stools and urgent need for defecation), indigestion syndrome (borborygmus, abdominal distension, eructation and increased flatus) and constipation syndrome (constipation, hard stools, and feeling of incomplete evacuation).
The GSRS is a disease-specific instrument of 15 items combined into five symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhea, and Constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms. The total GSRS range of scores is 15 to 105 with higher scores meaning the worst of symptoms."|screening, 2, 6 and 12 weeks|One participant in the myfortic group was ineligible||units on a scale||Standard Deviation|Mean
724219|NCT00336856|Secondary|Overall Survival|time from start of protocol therapy until death from any cause|Up to 30 months|||months||95% Confidence Interval|Median
724220|NCT00336856|Secondary|Time to Progression|time from start of protocol therapy until objective tumor progression|Up to 30 months|||months||95% Confidence Interval|Median
724222|NCT00336895|Primary|Gastrointestinal Side Effects and Quality of Life (-Subscales of GSRS)|"The GSRS contains 15 items, each rated on a seven- point likert scale from no discomfort to very severe discomfort. Based on a factor analysis, the 15 GSRS items breakdown into the following five scales: abdominal ( Abdominal pain, hunger pains and nausea): reflux syndrome (heartburn and acid regurgitation), diarrhea syndrome (diarrhea, loose stools and urgent need for defecation), indigestion syndrome ( borborygmus, abdominal distention, eructation and increased flatus) and constipation syndrome (constipation, hard stools and feeling of incomplete evacuation) The range of the scale for abdominal pain was 3 to 21, reflux 2 to 14, diarrhea 3 to 21, indigestion 4 to 28 and constipation 3 to 21.
Higher values represent more severe discomfort."|12 weeks|||units on a scale||Standard Deviation|Mean
724223|NCT00336895|Primary|Number of Participants With Cytomegalovirus Infection or Disease||12 weeks|||participants|||Number
724224|NCT00336895|Primary|Gastrointestinal Side Effects and Quality of Life (Total Score of GSRS)|"The gastrointestinal Symptom Rating Scale (GSRS) is a validated scale, the items range from 1= No discomfort at all to 7= Very severe discomfort.
The scale ranges from a minimal value of 15 ( No discomfort at all) to a maximum of 105 ( Very severe discomfort)
The GSRS contains 15 items, each rated on a seven- point likert scale from no discomfort to very severe discomfort. Based on a factor analysis, the 15 GSRS items breakdown into the following five scales: abdominal ( Abdominal pain, hunger pains and nausea): reflux syndrome (heartburn and acid regurgitation), diarrhea syndrome (diarrhea, loose stools and urgent need for defecation), indigestion syndrome ( borborygmus, abdominal distention, eructation and increased flatus) and constipation syndrome (constipation, hard stools and feeling of incomplete evacuation)"|screening, 2, 6 and 12 weeks|||units on a scale||Standard Deviation|Mean
724225|NCT00336973|Secondary|Proportion of Subjects With a PGA Rating of Clear (0) or Almost Clear (1)|The PGA scale used in this study was: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe|Day 168|Intent-to-treat (ITT)||percentage|||Number
724226|NCT00336973|Secondary|Proportion of Subjects With a PGA Rating of Clear (0) or Almost Clear (1)|The PGA scale used in this study was: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe|Day 84|Intent-to-treat (ITT)||percentage|||Number
724227|NCT00336973|Secondary|Proportion of Subjects With a PGA Rating of Clear (0), Almost Clear (1), or Mild (2)|The PGA scale used in this study was: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe|Day 168|Intent-to-treat (ITT)||percentage|||Number
724228|NCT00336973|Primary|Proportion of Subjects With a Physician's Global Assessment (PGA) Rating of Clear (0), Almost Clear (1), or Mild (2)|The PGA scale used in this study was: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe|Day 84|Intent-to-treat (ITT)||percentage|||Number
724229|NCT00337077|Secondary|Proportion of Patients With Measurable Disease Response|Measurable disease response was evaluated using RECIST (Response Evaluation Criteria in Solid Tumors) 1.0 criteria. Per RECIST criteria, complete response (CR) = disappearance of all target and non-target lesions. Partial response (PR)= >=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits. Measurable disease response = CR + PR. Only patients with measurable disease at baseline are included in this analysis.|Assessed every 9 weeks during treatment; after off-treatment, every 3 months if patient is <2 years from study entry and every 6 months if patient is 2-5 years from study entry|Eligible and treated patients with measurable disease at baseline are included in this analysis.||Proportion of participants||90% Confidence Interval|Number
724230|NCT00337077|Primary|Proportion of Patients With PSA Response|PSA response is defined as a PSA decline from baseline value by >=50%, or normalization of PSA (<0.2 ng/ml) confirmed by a second measurement greater than or equal to 4 weeks later.|Assessed every 3 weeks during treatment; after off-treatment, every 3 months if patient is <2 years from study entry and every 6 months if patient is 2-5 years|Eligible and treated patients are included in this analysis.||Proportion of participants||90% Confidence Interval|Number
724231|NCT00337103|Primary|Progression Free Survival (PFS)|PFS was defined as the time (in days) from the date of randomization to the date of the first sign of disease progression based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 (v 1.1) or date of death, regardless of cause. Disease progression was measured by computed tomography (CT) and magnetic resonance imaging (MRI) performed on lesions targeted at baseline for tumor assessment. Disease progression (as assessed by independent review of the imaging scans) per RECIST v 1.1 was defined as at least a 20% increase in the sum of the diameters of the target lesions (taking as reference the smallest sum on study, including the baseline sum if that is the smallest), and an absolute increase of at least 5 mm. Note that the appearance of one or more new lesions was also considered as PD.|From date of randomization to the date of disease progression or death (whichever occurred first), assessed up to data cutoff date 12 Mar 2012 or up to approximately 6 years|Data was analyzed using Safety Population defined as all subjects who received at least one dose of study treatment.||Days||Full Range|Median
724232|NCT00337103|Primary|Overall Survival (OS)|OS was measured from the date of randomization until the date of death from any cause, or the last date the participant was known to be alive. Participants who were lost to follow-up or who were alive at the date of data cutoff were censored. The censoring rules for OS were as follows: 1) if the participant died during the study, the date of death was considered the end date, 2) if the participant was still alive at data cutoff, the date of data cutoff was considered the end date, and 3) if the participant was lost to follow-up before data cutoff, the date they were last known to be alive was considered the end date. Participants who survived past the end of the study were counted as in the full study period. If death occurred after data cutoff, the end date was to be censored at the time of data cutoff.|From date of randomization until date of death from any cause, assessed up to data cutoff date of 12 Mar 2012, or up to approximately 6 years|Data was analyzed using the Intent-to-Treat Population defined as all participants who were randomized.||Days||Full Range|Median
724233|NCT00337129|Secondary|Participants With a Given Type of AE|The NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 3.0 was utilized.|Every 3 weeks while on protocol therapy, up to 3 years.|All eligible patients who started protocol treatment are included in analysis of toxicity||participants|||Number
724234|NCT00337129|Secondary|Overall Survival|Overall survival was defined as the time from the date of registration to the date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Every 3 months for first year, then every six months thereafter up to a maximum of 3 years from registration.|Only eligible patients were included in the analysis.||months||95% Confidence Interval|Median
724235|NCT00337129|Secondary|Progression-Free Survival|Progression-free survival was defined as the time from date of registration to the date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free were censored at date of last contact.|Every 6 weeks until progression of disease up to a maximum of 3 years after registration.|||months||95% Confidence Interval|Median
724236|NCT00337129|Primary|Response Probability (Confirmed Complete and Partial Responses)|Response was defined per RECIST. Complete response (CR) was defined as complete disappearance of all baseline measurable and non-measurable disease with no new lesions. Partial response (PR) was defined as at least 30% decrease under baseline of the sum of longest diameters of all target measurable lesions with no unequivocal progression of non-measurable disease and no new lesions. A CR or PR must be confirmed by a second determination at least 4 weeks apart. All disease must have been assessed using the same technique as baseline.|Every 6 weeks until progression of disease up to a maximum of 3 years after registration|Only eligible patients were included in the analysis||participants|||Number
724237|NCT00337168|Secondary|Toxicity|Number of patients with Grade 3-5 adverse events that are related to study drug by given type of adverse event|Patients were assess for adverse events after each induction cycle (up to two cycles) and after the one consolidation cycle|Eligible patients who started therapy||Participants with a given type of AE|||Number
724238|NCT00337168|Secondary|Number of Patients With Very Poor Risk Cytogenetics||On average, 2 weeks before treatment started|Eligible patients with acceptable centrally reviewed cytogenetics||participants|||Number
724239|NCT00337168|Secondary|Expression of Nucleoside Transporters|Expression was examined in paraffin-embedded tissue by immunohistochemistry. Intensities were scored on a 0-2+ scale. High expression was a score of 2+.|On average, two weeks before treatment started|Eligible patients who submitted paraffin-embedded tissue||participants|||Number
724240|NCT00337168|Primary|Number of Patients With Complete Remission|Complete remission is defined as: less than 5% bone marrow blasts, neutrophils greater or equal to 1,000 per microliter, platelets greater than 100,000 per microliter, no blasts in the peripheral blood, and no extramedullary disease|Between day 28 and day 35 inclusive|Eligible patients who started therapy||participants|||Number
724241|NCT00337194|Other Pre-specified|Fc Gamma Receptor Polymorphisms|Fisher’s exact test with 2-sided alpha = 0.05 will be used to compare the response probabilities in patients with V/V (valine expression), V/F (heterozygous), and F/F (homozygous for phenylalanine) for each of Fc gamma RIIIa a|Baseline|Fc gamma receptor polymorphisms were assessed in 28 participants.||participants|||Number
724242|NCT00337194|Other Pre-specified|sCD30 Levels|A 2-sided t-test with alpha = 0.05 will be used to compare sCD30 levels between responders (OR) and non-responders groups.|Up to day 21 of course 6|Nine participants submitted pretreatment sCD30 samples.||U/ml||Full Range|Median
724243|NCT00337194|Other Pre-specified|Peak Serum Level of Monoclonal Antibody SGN-30|Record the highest serum level of monoclonal antibody SGN-30 achieved.|Up to day 21 of course 6|Data was only available on 10 participants from Arm 1. (No participants from Arm II were evaluable for this endpoint as they did not receive SGN-30 per protocol.)||mg/ml||Full Range|Median
724244|NCT00337194|Secondary|Overall Survival (OS) At 1 Year|Percentage of patients who were alive at 1 year. The 1-year survival rate was estimated using the Kaplan Meier method.|1 year|||percentage of participants||95% Confidence Interval|Median
724245|NCT00337194|Secondary|Event Free Survival (EFS)|Event free survival is the time from trial entry until progression, death, or termination of treatment due to nonresponse. Patients who went on to receive a stem cell transplant (SCT) were not censored from the EFS survival at the time of transplant and were only considered failures at the time of relapse or death from any cause. The median EFS with 95% confidence interval (CI) was estimated using the Kaplan Meier method.|Up to 10 years|||months||95% Confidence Interval|Median
724246|NCT00337194|Primary|Number of Participants With Overall Response (OR)|The number of participants who respond (complete or partial) to treatment. Response was defined using the revised criteria for malignant lymphoma. Complete response (CR): complete disappearance of all detectable disease; partial response (PR): >= 50% reduction in sum of the product of diameters of indicator lesions.|Up to 10 years|||participants|||Number
724247|NCT00337207|Primary|Tumoral Blood Flow Changes||Before and after treatment||||||
724248|NCT00337207|Primary|Progression-free Survival at 6 Months|The number of patients experiencing progression free survival (PFS) was calculated at the 6-month time point.|After all patients have surpassed the 6 month post-treatment timepoint|1 patient became deceased due to toxicity prior to the 6 month time point and thus, was not evaluable for the 6 month progression free survival endpoint.||Participants|||Number
724249|NCT00337207|Primary|Safety of Treatment||Throughout treatment and up to 30 days post-treatment||||||
724250|NCT00337272|Secondary|Daytime Function - Distress|The subject rates 4 questions related to distress on a scale of 0 through 10 for each question, where 0 is not bad and 10 is as bad as possible. The scores of these 4 questions are combined and normalized, and used to describe distress.|Once during the screening period; once during the treatment period; twice during the withdrawal period for a total of 4 assessments|Screening period: 11 patients with 6 treated with Placebo and 5 with Ramelteon. Treatment period: 9 patients with 4 treated with Placebo and 5 with Ramelteon. Withdrawal period: 8 patients with 4 treated with Placebo and 4 with Ramelteon.||Units on a Scale||Standard Deviation|Mean
724251|NCT00337272|Secondary|Daytime Function - Despair|The subject rates 7 questions related to despair on a scale of 0 through 10 for each question, where 0 is not bad and 10 is as bad as possible. The scores of these 7 questions are combined and normalized, and used to describe despair.|Once during the screening period; once during the treatment period; twice during the withdrawal period for a total of 4 assessments|Screening period: 11 patients with 6 treated with Placebo and 5 with Ramelteon. Treatment period: 9 patients with 4 treated with Placebo and 5 with Ramelteon. Withdrawal period: 8 patients with 4 treated with Placebo and 4 with Ramelteon.||Units on a Scale||Standard Deviation|Mean
724252|NCT00337272|Secondary|Daytime Function - Fatigue|The subject rates her fatigue on a scale of 0 through 10, where 0 is not a problem and 10 is as bad as possible.|Once during the screening period; once during the treatment period; twice during the withdrawal period for a total of 4 assessments|Screening period: 12 patients with 6 treated with Placebo and 6 with Ramelteon. Treatment period: 11 patients with 4 treated with Placebo and 7 with Ramelteon. Withdrawal period: 8 patients with 4 treated with Placebo and 4 with Ramelteon.||Units on a Scale||Standard Deviation|Mean
724253|NCT00337272|Secondary|Qualitative Evaluation of Sleep - Quality of Sleep|The subject rates the quality of her sleep on a scale of 0 through 10, where 0 is a very bad night of sleep and 10 is a very good night of sleep.|Every morning during the screening, treatment, and withdrawal periods|Screening period: 14 patients with 6 treated with Placebo and 8 with Ramelteon. Treatment period: 13 patients with 5 treated with Placebo and 8 with Ramelteon. Withdrawal period: 10 patients with 4 treated with Placebo and 6 with Ramelteon.||Units on a Scale||Standard Deviation|Mean
724254|NCT00337272|Secondary|Qualitative Evaluation of Sleep - Global Sleep Impression|"The Patient Global Impression is a 7-point scale which asks How much has your sleep improved? with the following anchors: no improvement, minimal improvement, slight improvement, moderate improvement, very good improvement, near complete improvement, and complete improvement."|Once during the withdrawal period|||Participants|||Number
724255|NCT00337272|Secondary|Quantitative Sleep Parameters - Number of Awakenings|The subject reports how many times she woke up during the night.|Every morning during the screening, treatment, and withdrawal periods|Screening period: 14 patients with 6 treated with Placebo and 8 with Ramelteon. Treatment period: 13 patients with 5 treated with Placebo and 8 with Ramelteon. Withdrawal period: 10 patients with 4 treated with Placebo and 6 with Ramelteon.||Awakenings||Standard Deviation|Mean
724256|NCT00337272|Secondary|Quantitative Sleep Parameters - Total Sleep Time|The subject reports how many hours of sleep she got.|Every morning during the screening, treatment, and withdrawal periods|Screening period: 14 patients with 6 treated with Placebo and 8 with Ramelteon. Treatment period: 13 patients with 5 treated with Placebo and 8 with Ramelteon. Withdrawal period: 10 patients with 4 treated with Placebo and 6 with Ramelteon.||Hours||Standard Deviation|Mean
724257|NCT00337272|Primary|Sleep Efficiency|Total time in bed is calculated as the time the subject got out of bed minus the time the subject went to bed. The total sleep time is reported by the subject. Percent sleep efficiency is calulated as 100*(total sleep time divided by total time in bed).|Every morning during the screening, treatment, and withdrawal periods|Screening period: 14 patients with 6 treated with Placebo and 8 with Ramelteon. Treatment period: 13 patients with 5 treated with Placebo and 8 with Ramelteon. Withdrawal period: 10 patients with 4 treated with Placebo and 6 with Ramelteon.||Percent sleep efficiency||Standard Deviation|Mean
724258|NCT00337285|Secondary|Change in PSQI Total Score From Baseline at Up to One Year|Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire consisting of 18 items which generates seven component scores on a scale from 0 (better sleep) to 3 (worse sleep) resulting in a global score of 0-21, where a higher number reflects worse sleep quality.|up to 1 year|Safety population (Defined as all subjects who were enrolled and who received at least one dose of the investigational product.)||Units on a scale||Standard Deviation|Mean
724259|NCT00337285|Secondary|Number of Participants With Improvement on CGI-I|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement includes 1 and 2 on the scale.|Up to 1 year|ITT||Participants|||Number
724260|NCT00337285|Primary|Change in ADHD-RS-IV Total Score From Baseline at Up to One Year|Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|up to one year|Intent-to-treat (ITT). Defined as all subjects who were treated and had both the baseline and at least one post-baseline primary efficacy measurement (i.e., ADHD-RS-IV total score)||Units on a scale||Standard Deviation|Mean
724261|NCT00337350|Primary|Change From Baseline in Acute Insulin Response to Glucose (AIRG)|Acute insulin response to glucose (AIRG) was assessed using a Frequently Sampled Intravenous Glucose Tolerance Test (FSIVGTT), performed at Baseline and at week 8 (study endpoint). Subjects in the Rosiglitazone treatment arm were compared to subjects in the placebo treatment arm on their change in SG between Baseline and week 8. AIRG was calculated from plasma glucose and serum insulin values using the MINMOD Millennium computer program. AIRG measures the acute(0–10 min) beta\ cell response to a glucose load calculated by the areas under the curve higher than basal insulin values. The AIRG was assessed as the incremental area under the curve (calculated by the trapezoid rule) from 0 to 10 min of the FSIVGTT.|baseline, week 8|||Units/mL per 10 minutes||Standard Deviation|Mean
724262|NCT00337350|Primary|Change From Baseline on Glucose Utilization (SG)|Glucose utilization (SG) was assessed using a Frequently Sampled Intravenous Glucose Tolerance Test (FSIVGTT), performed at Baseline and at week 8 (study endpoint). Subjects in the Rosiglitazone treatment arm were compared to subjects in the placebo treatment arm on their change in SG between Baseline and week 8. SG was calculated from plasma glucose and serum insulin values using the MINMOD Millennium computer program. SG represents the net fractional glucose clearance rate because of the increase in glucose independent of any increase in circulating insulin concentrations above baseline.|baseline, week 8|||min^-1||Standard Deviation|Mean
724263|NCT00337350|Primary|Change From Baseline in Insulin Sensitivity|Insulin Sensitivity (IS) was assessed using a Frequently Sampled Intravenous Glucose Tolerance Test (FSIVGTT), performed at Baseline and at week 8 (study endpoint). Subjects in the Rosiglitazone treatment arm were compared to subjects in the placebo treatment arm on their change in IS between Baseline and week 8. SI was calculated from plasma glucose and serum insulin values using the MINMOD Millennium computer program. SI represents the increase in net fractional glucose clearance rate per unit change in serum insulin concentration after the intravenous glucose load (microUnits/mL).|baseline, week 8|||microUnits/mL||Standard Deviation|Mean
724264|NCT00337428|Primary|Geometric Mean Titers (GMTs) For Pertussis (Anti-FIM) One Month Postvaccination With REPEVAX™|Serum antibodies to Pertussis Fimbrial Agglutinogens Antibody (anti-FIM) were measured with an ELISA. Titers were reported in ELU/mL and the lower limit of quantitation for the assay was 5.0 ELU/mL. GMTs from participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs for each HPV Type using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction.|Up to 1 Month (1 Month Postdose 1)|Per-protocol population: participants must have no major protocol violations and must have post-vaccination data.||ELISA units/mL||95% Confidence Interval|Mean
724796|NCT00339040|Secondary|CD4 Percent Over Time||Arm A week 0, 8, 12, 24, 28, 72, 96, 100 and 108; Arm B week 0, 8, 12, 24, 28, 72, 96, 100, 104, 108, 120, and 124.|Any participant who received at least one study vaccine/placebo and with non-missing CD4%.||percentage of total lymphocytes||95% Confidence Interval|Mean
724265|NCT00337428|Primary|Geometric Mean Titers (GMTs) For Pertussis (Anti-PRN) One Month Postvaccination With REPEVAX™|Serum antibodies to Pertussis Pertactin (anti-PRN) were measured with an ELISA. Titers were reported in ELU/mL and the lower limit of quantitation for the assay was 5.0 ELU/mL. GMTs from participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction.|Up to 1 Month (1 Month Postdose 1)|Per-protocol population: participants must have no major protocol violations and must have post-vaccination data.||ELISA units/mL||95% Confidence Interval|Mean
724266|NCT00337428|Primary|Geometric Mean Titers (GMTs) For Pertussis (Anti-FHA) One Month Postvaccination With REPEVAX™|Serum antibodies to Pertussis Filamentous Haemagglutin Antibody (anti-FHA) were measured with an ELISA. Titers were reported in ELU/mL and the lower limit of quantitation for the assay was 3.0 ELU/mL. GMTs from participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction.|Up to 1 Month (1 Month Postdose 1)|Per-protocol population: participants must have no major protocol violations and must have post-vaccination data.||ELISA units/mL||95% Confidence Interval|Mean
724267|NCT00337428|Primary|Geometric Mean Titers (GMTs) For Pertussis (Anti-PT) One Month Postvaccination With REPEVAX™|Serum antibodies to Pertussis Toxoid Antibody (anti-PT) were measured with an enzyme-linked immunosorbent assay (ELISA). Titers were reported in ELISA units/mL (ELU/mL) and the lower limit of quantitation for the assay was 5.0 ELU/mL. GMTs from participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction.|Up to 1 Month (1 Month Postdose 1)|Per-protocol population: participants must have no major protocol violations and must have post-vaccination data.||ELISA units/mL||95% Confidence Interval|Mean
724268|NCT00337428|Primary|Number of Participants Who Achieved Acceptable Levels of Titers to Poliovirus Type 3 (Poliovirus Type 3 ≥1:8) One Month Postvaccination With REPEVAX™|Poliovirus antibody was measured using a poliovirus neutralization assay that assesses the ability of serial dilutions of participant sera to neutralize known amounts of type-specific Sabin poliovirus strains (Types 1, 2, and 3). An acceptable level of response was defined as participants who achieve detectable serum neutralizing antibodies at a ≥1:8 dilution of sera. The response of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) was compared to participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared response levels using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.|Up to 1 Month (1 Month Postdose 1)|Per-protocol population: participants must have no major protocol violations and must have post-vaccination data.||participants|||Number
724269|NCT00337428|Primary|Number of Participants Who Achieved Acceptable Levels of Titers to Poliovirus Type 2 (Poliovirus Type 2 ≥1:8) One Month Postvaccination With REPEVAX™|Poliovirus antibody was measured using a poliovirus neutralization assay that assesses the ability of serial dilutions of participant sera to neutralize known amounts of type-specific Sabin poliovirus strains (Types 1, 2, and 3). An acceptable level of response was defined as participants who achieve detectable serum neutralizing antibodies at a ≥1:8 dilution of sera. The response of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) was compared to participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared response levels using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.|Up to 1 Month (1 Month Postdose 1)|Per-protocol population: participants must have no major protocol violations and must have post-vaccination data.||participants|||Number
724270|NCT00337428|Primary|Number of Participants Who Achieved Acceptable Levels of Titers to Poliovirus Type 1 (Poliovirus Type 1 ≥1:8) One Month Postvaccination With REPEVAX™|Poliovirus antibody was measured using a poliovirus neutralization assay that assesses the ability of serial dilutions of participant sera to neutralize known amounts of type-specific Sabin poliovirus strains (Types 1, 2, and 3). An acceptable level of response was defined as participants who achieve detectable serum neutralizing antibodies at a ≥1:8 dilution of sera. The response of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) was compared to participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared response levels using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.|Up to 1 Month (1 Month Postdose 1)|Per-protocol population: participants must have no major protocol violations and must have post-vaccination data.||participants|||Number
724271|NCT00337428|Primary|Number of Participants Who Achieved Acceptable Levels of Titers to Tetanus (Tetanus ≥0.1 IU/mL) One Month Post-vaccination With REPEVAX™|Tetanus antitoxin titers were measured using an indirect, non-competitive enzyme immunoassay (EIA) that compares the antitoxin level in the serum of participants with the World Health Organization International Standard for Tetanus Immunoglobulin. An acceptable level of response was defined as ≥0.1 International Units (IU)/milliliter (mL). Response levels of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared response levels using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.|Up to 1 Month (1 Month Postdose 1)|Per-protocol population: participants must have no major protocol violations and must have post-vaccination data.||participants|||Number
724292|NCT00337467|Secondary|Percentage of Participants With Virological Rebound Through Week 48|Virological rebound is defined as confirmed on-treatment HIV RNA >= 400 c/mL at 2 consecutive visits or last on-treatment HIV RNA >=400 c/mL followed by discontinuation of study therapy. In addition, virologic rebound defined based on HIV RNA >=50 c/m, latter analysis performed on subjects with baseline HIV RNA < 50 c/mL.|Week 48|Treated participants. For the second row (n=60), one subject was excluded because of baseline HIV RNA > 50 c/mL.||percentage of participants|||Number
724272|NCT00337428|Primary|Number of Participants Who Achieved Acceptable Levels of Titers to Diphtheria (Diphtheria ≥0.1 IU/mL) One Month Post-vaccination With REPEVAX™|Diphtheria antitoxin titers were measured using a neutralization assay in Vero cell culture that compares the antitoxin level in the serum of participants with the World Health Organization International Standard for Diphtheria Antitoxin. An acceptable level of response was defined as ≥0.1 International Units (IU)/milliliter (mL). Response levels of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared response levels using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.|Up to 1 Month (1 Month Postdose 1)|Per-protocol population: participants must have no major protocol violations and must have post-vaccination data.||participants|||Number
724273|NCT00337428|Primary|Number of Participants Who Seroconverted for HPV Type 18 (HPV 18 ≥24 mMU/mL) by Month 7 (4 Weeks Postdose 3)|Seroconversion to HPV Type 18 was defined as changing serostatus from seronegative to seropositive as measured by GMT. The cutoff value for HPV seropositivity was ≥24 mMU/mL. Seroconversion of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) was compared to seroconversion of participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared seroconversion for each HPV type using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.|Up to 7 Months (4 Weeks Postdose 3)|Per-protocol population: participants must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.||participants|||Number
724274|NCT00337428|Primary|Number of Participants Who Seroconverted for HPV Type 16 (HPV 16 ≥20 mMU/mL) by Month 7 (4 Weeks Postdose 3)|Seroconversion to HPV Type 16 was defined as changing serostatus from seronegative to seropositive as measured by GMT. The cutoff value for HPV seropositivity was ≥20 mMU/mL. Seroconversion of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) was compared to seroconversion of participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared seroconversion for each HPV type using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.|Up to 7 Months (4 Weeks Postdose 3)|Per-protocol population: participants must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.||participants|||Number
724275|NCT00337428|Primary|Number of Participants Who Seroconverted for HPV Type 11 (HPV 11 ≥16 mMU/mL) by Month 7 (4 Weeks Postdose 3)|Seroconversion to HPV Type 11 was defined as changing serostatus from seronegative to seropositive as measured by GMT. The cutoff value for HPV seropositivity was ≥16 mMU/mL. Seroconversion of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) was compared to seroconversion of participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared seroconversion for each HPV type using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.|Up to 7 Months (4 Weeks Postdose 3)|Per-protocol population: participants must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.||participants|||Number
724276|NCT00337428|Primary|Number of Participants Who Seroconverted for HPV Type 6 (HPV 6 ≥20 mMU/mL) by Month 7 (4 Weeks Postdose 3)|Seroconversion to HPV Type 6 was defined as changing serostatus from seronegative to seropositive as measured by GMT. The cutoff value for HPV seropositivity was ≥20 mMU/mL. Seroconversion of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) was compared to seroconversion of participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared seroconversion for each HPV type using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.|Up to 7 Months (4 Weeks Postdose 3)|Per-protocol population: participants must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.||participants|||Number
724277|NCT00337428|Primary|Geometric Mean Titers (GMTs) for Anti-HPV 18 at Month 7 (4 Weeks Postdose 3)|Serum antibodies to HPV Type 18 were measured with a Competitive Luminex Immunoassay. Titers were reported in milli Merck Units (mMU)/milliliter (mL). GMTs from participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs for each HPV type using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction.|Up to 7 Months (4 Weeks Postdose 3)|Per-protocol population: participants must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.||milliMerck units/mL||95% Confidence Interval|Mean
724278|NCT00337428|Primary|Geometric Mean Titers (GMTs) for Anti-HPV 16 at Month 7 (4 Weeks Postdose 3)|Serum antibodies to HPV Type 16 were measured with a Competitive Luminex Immunoassay. Titers were reported in milli Merck Units (mMU)/milliliter (mL). GMTs from participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs for each HPV type using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction.|Up to 7 Months (4 Weeks Postdose 3)|Per-protocol population: participants must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.||milliMerck units/mL||95% Confidence Interval|Mean
724293|NCT00337467|Secondary|Percentage of Participants With Treatment Failure Through Week 96|Treatment Failure through Week 96 defined as virologic rebound (HIV RNA >=400 c/mL) on or before Week 96 or study discontinuation before Week 96. In addition, treatment failure defined based on HIV RNA >= 50 c/mL, latter analysis performed on treated subjects with baseline HIV RNA < 50 c/mL.|Week 96|Treated participants. For the second row (n=60), one subject was excluded because of baseline HIV RNA > 50 c/mL.||percentage of participants|||Number
724420|NCT00332696|Secondary|Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 1|Recurrence of bowel obstruction was confirmed by abdominal X-ray.|1 Month|Participants from the Intent-to-treat population (consisting of all randomized participants who received at least one dose of study drug) for whom data was available at Month 1.||Participants|||Number
724279|NCT00337428|Primary|Geometric Mean Titers (GMTs) for Anti-HPV 11 at Month 7 (4 Weeks Postdose 3)|Serum antibodies to HPV Type 11 were measured with a Competitive Luminex Immunoassay. Titers were reported in milli Merck Units (mMU)/milliliter (mL). GMTs from participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs for each HPV type using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction.|Up to 7 Months (4 Weeks Postdose 3)|Per-protocol population: participants must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.||milliMerck units/mL||95% Confidence Interval|Mean
724280|NCT00337428|Primary|Geometric Mean Titers (GMTs) for Anti-HPV 6 at Month 7 (4 Weeks Postdose 3)|Serum antibodies to HPV Type 6 were measured with a Competitive Luminex Immunoassay. Titers were reported in milli Merck Units (mMU)/milliliter (mL). GMTs from participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs for each HPV type using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction.|Up to 7 Months (4 Weeks Postdose 3)|Per-protocol population: participants must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.||milliMerck units/mL||95% Confidence Interval|Mean
724281|NCT00337467|Secondary|Number of Participants With Genotype Substitutions for Virologic Rebounds (HIV-RNA ≥ 400 c/mL) Through Week 96|International Aids Society of the United States (IAS-USA)-defined major protease inhibitor (PI) substitutions are V32I, L33F, M46I/L, I47V, G48V, I50L/V, I54M/L, I76V, I82A/F/T/S, I84V, N88S, and L90M. Reverse Transcriptase (RT) are TAMS and M184V.|Week 96|Number of participants with virologic rebounds (HIV-RNA ≥ 400 c/mL) through Week 96.||participants|||Number
724282|NCT00337467|Secondary|Number of Participants With Genotype Substitutions for Virologic Rebounds (HIV-RNA ≥ 400 c/mL) Through Week 48|International Aids Society of the United States (IAS-USA)-defined major protease inhibitor (PI) substitutions are V32I, L33F, M46I/L, I47V, G48V, I50L/V, I54M/L, I76V, I82A/F/T/S, I84V, N88S, and L90M. Reverse Transcriptase (RT) are TAMS and M184V.|Week 48|Number of participants with virologic rebounds (HIV-RNA ≥ 400 c/mL) through Week 48.||participants|||Number
724283|NCT00337467|Secondary|Mean Percent Changes From Baseline in Fasting Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Non-HDL Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, and Triglycerides at Week 96|Lipid values after starting lipid-reducing agents are excluded from analyses. Baseline values are provided in Baseline Characteristics.|Baseline, Week 96|n=number of treated participants with baseline measure and measure at Week 96||percent change||Standard Deviation|Mean
724284|NCT00337467|Secondary|Mean Percent Changes From Baseline in Fasting Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Non-HDL Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, and Triglycerides at Week 48|Lipid values after starting lipid-reducing agents are excluded from analyses. Baseline values are provided in Baseline Characteristics.|Baseline, Week 48|n= number of treated participants with baseline measure and measure at Week 48||percent change||Standard Deviation|Mean
724285|NCT00337467|Secondary|Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition that does not necessarily have a causal relationship to treatment. SAE=any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. AE grades are: mild (1), moderate (2), severe (3), life-threatening (4), and death (5).|From Baseline through Week 96|Treated Participants||percentage of participants|||Number
724286|NCT00337467|Secondary|Mean Change From Baseline in CD4 Cell Count at Week 96||Baseline, Week 96|n=number of participants with CD4 cell count at baseline and at Week 96.||cells /mm3||Standard Deviation|Mean
724287|NCT00337467|Secondary|Mean Change From Baseline in CD4 Cell Count at Week 48||Baseline, Week 48|n=number of participants with CD4 cell count at baseline and at Week 48.||cells /mm3||Standard Deviation|Mean
724288|NCT00337467|Secondary|Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 24||Baseline, Week 24|n=number of participants with CD4 cell count at baseline and at Week 24||cells /mm3||Standard Deviation|Mean
724289|NCT00337467|Secondary|Proportion of Participants With Virologic Rebound Through Week 96|Virologic rebound is defined as confirmed on-study HIV RNA ≥ 400 c/mL or last on-study HIV RNA ≥ 400 c/mL followed by treatment discontinuation.|Through Week 96|This analysis was not done; however, percentage of participants with virologic rebound through Weeks 48 and 96 are reported in Secondary Outcome Measures 3 and 4. Time to reatment failure (defined as the earlier of virologic rebound or treatment discontinuation) is reported in Secondary Outcome Measure 5.||proportion of participants|||Number
724290|NCT00337467|Secondary|Cumulative Proportion of Participants Without Treatment Failure Through Week 100|This Kaplan-Meier life table reports the cumulative proportion of participants without treatment failure up to the end of the respective time interval. Failure time is measured from the start of study therapy, and is based on the earliest event defining failure (virologic rebound at or before Week 96, or discontinuation prior to Week 96).|Through Week 100|treated participants; n= the number at risk entering interval||proportion of participants|||Number
724291|NCT00337467|Secondary|Percentage of Participants With Virological Rebound Through Week 96|Virological rebound is defined as confirmed on-treatment HIV RNA >= 400 c/mL at 2 consecutive visits or last on-treatment HIV RNA >=400 c/mL followed by discontinuation of study therapy. In addition, virologic rebound defined based on HIV RNA >=50 c/m, latter analysis performed on subjects with baseline HIV RNA < 50 c/mL.|Week 96|Treated participants. For the second row (n=60), one subject was excluded because of baseline HIV RNA > 50 c/mL.||percentage of participants|||Number
724294|NCT00337467|Primary|Percentage of Participants With Treatment Failure Through Week 48|Treatment Failure through Week 48 defined as virologic rebound (HIV RNA >=400 c/mL) on or before Week 48 or study discontinuation before Week 48. Virological rebound is defined as confirmed on-treatment HIV ribonucleic acid (RNA) >= 400 c/mL at 2 consecutive visits or last on-treatment HIV RNA >=400 c/mL followed by discontinuation of study therapy.|Week 48|Treated participants||Percentage of Participants|||Number
724295|NCT00337571|Secondary|Change From Baseline in Body Weight|Adjusted mean change (Week 8 - baseline) in body weight|Week 8|Safety population=all randomized participants minus 3 patients in the placebo group (1 no longer met study criteria, 2 did not have measurement at baseline and Week 8), and 1 participant in the 5-mg group who withdrew consent. Data set is LOCF.||kilograms||Standard Error|Mean
724296|NCT00337571|Secondary|Summary of Safety|Deaths, Adverse Events (AEs), Serious AEs (SAEs), Treatment-Emergent AEs and AEs leading to discontinuation|continuously throughout the study|Safety population=all randomized participants minus 1 patients in the placebo group (no longer met study criteria), and 1 participant in the 5-mg group who withdrew consent.||participants|||Number
724297|NCT00337571|Secondary|Mean Change (Week 8 - Baseline) in CGI-Severity (CGI-S)|A CGI-S assessment (a 7-point scale to evaluate the severity of symptoms) was performed at baseline (1=no symptoms; 7=very severe symptoms). The patient’s improvement relative to the symptoms at baseline on were assessed on a 7-point CGI-I (1=very much improved; 7=very much worse). A decrease in value indicates improvement.|Week 8|Efficacy population=all randomized participants minus 3 patients in the placebo group (1 lost to follow-up, 1 withdrew consent, 1 no longer met study criteria), 1 participant in the 5-mg group who withdrew consent, and 1 participant in the 15-mg group who had elevated potassium levels. Data set is LOCF.||units on a scale||Standard Error|Mean
724298|NCT00337571|Secondary|Mean Change (Week 8 - Baseline) in the Other ABC Subscale Scores|Mean change (Week 8 - baseline) in the other ABC subscale scores (lethargy/social withdrawal; stereotypic behavior; hyperactivity/ noncompliance; inappropriate speech). A decrease in value indicates improvement.|Week 8|Efficacy population=all randomized participants minus 3 patients in the placebo group (1 lost to follow-up, 1 withdrew consent, 1 no longer met study criteria), 1 participant in the 5-mg group who withdrew consent, and 1 participant in the 15-mg group who had elevated potassium levels. Data set is LOCF.||units on a scale||Standard Error|Mean
724299|NCT00337571|Secondary|Mean Change (Week 8 - Baseline) in the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS; Compulsion Scale Only)|CY-BOCS=10-item assessment of obsessive-compulsive symptoms in patients <18 years. 5 items pertaining to compulsions rate symptoms (time spent, interference with functioning, distress, resistance, control) on a 5-point scale (0=no symptoms/minimum severity, 4=extreme symptoms/maximum severity). A decreased in value indicates improvement.|Week 8|Efficacy population=all randomized participants minus 3 patients in the placebo group (1 lost to follow-up, 1 withdrew consent, 1 no longer met study criteria), 1 participant in the 5-mg group who withdrew consent, and 1 participant in the 15-mg group who had elevated potassium levels. Data set is LOCF.||units on a scale||Standard Error|Mean
724300|NCT00337571|Secondary|Number of Participants With Response at Week 8|Response defined as a ≥ 25% reduction from baseline to endpoint in the ABC Irritability Subscale score and a CGI-I score of 1 or 2 at endpoint.|Week 8|Efficacy population=all randomized participants minus 3 patients in the placebo group (1 lost to follow-up, 1 withdrew consent, 1 no longer met study criteria), 1 participant in the 5-mg group who withdrew consent, and 1 participant in the 15-mg group who had elevated potassium levels. Data set is LOCF.||Participants|||Number
724301|NCT00337571|Secondary|Mean Clinical Global Impressions Improvement Scale (CGI-I) Score|The CGI scale is a clinician-rated global assessment of a patient's improvement over time. Baseline assessment rated a patient's condition on a 7-point scale (1=no symptoms, 7=very severe symptoms). Subsequent assessed improvement relative to baseline symptoms on a 7-point CGI-I item scale (1=very much improved, 7=very much worse).|Week 8|Efficacy population=all randomized participants minus 3 patients in the placebo group (1 lost to follow-up, 1 withdrew consent, 1 no longer met study criteria), 1 participant in the 5-mg group who withdrew consent, and 1 participant in the 15-mg group who had elevated potassium levels. Data set is LOCF.||units on a scale||Standard Error|Mean
724302|NCT00337571|Primary|Mean Change (Week 8 - Baseline) in the Autistic Behavior Checklist (ABC) Irritability Subscale Score|The ABC is a 58-item informant-based assessment of problem behaviors in children/adolescents with mental retardation. Items are rated on a 4-point scale (0=no problem, 3=severe problem), and resolve into 5 domain subscales. A decrease in score indicates improvement.|Week 8|Efficacy population=all randomized participants minus 3 patients in the placebo group (1 lost to follow-up, 1 withdrew consent, 1 no longer met study criteria), 1 participant in the 5-mg group who withdrew consent, and 1 participant in the 15-mg group who had elevated potassium levels. Data set is LOCF.||units on a scale||Standard Error|Mean
724303|NCT00337610|Secondary|Change From Baseline in A1C at Week 30|A1C was measured as a percent. Thus, this change from baseline reflects the Week 30 A1C percent minus the Week 0 A1C percent.|Baseline and Week 30|The full-analysis-set (FAS) population included all patients with at least one dose of double-blind study therapy, and with a baseline value and ≥1 postbaseline value for this outcome. Data following glycemic rescue were treated as missing. Missing data were handled using the LOCF method.||Percent||95% Confidence Interval|Least Squares Mean
724304|NCT00337610|Secondary|Change From Baseline in 2 Hr-PMG at Week 18|Change from baseline at Week 18 is defined as Week 18 minus Week 0.|Baseline and Week 18|The full-analysis-set (FAS) population included all patients with at least one dose of double-blind study therapy, and with a baseline value and ≥1 postbaseline value for this outcome. Data following glycemic rescue were treated as missing. Missing data were handled using the LOCF method.||mg/dL||95% Confidence Interval|Least Squares Mean
724305|NCT00337610|Secondary|Change From Baseline in FPG at Week 18|Change from baseline at Week 18 is defined as Week 18 FPG minus Week 0 FPG.|Baseline and Week 18|The full-analysis-set (FAS) population included all patients with at least one dose of double-blind study therapy, and with a baseline value and ≥1 postbaseline value for this outcome. Data following glycemic rescue were treated as missing. Missing data were handled using the LOCF method.||mg/dL||95% Confidence Interval|Least Squares Mean
724306|NCT00337610|Primary|Change From Baseline in A1C at Week 18|A1C was measured as a percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.|Baseline and Week 18|The full-analysis-set (FAS) population included all patients with at least one dose of double-blind study therapy, and with a baseline value and ≥1 postbaseline value for this outcome. Data following glycemic rescue were treated as missing. Missing data were handled using the last observation carrying forward (LOCF) method.||Percent||95% Confidence Interval|Least Squares Mean
724307|NCT00337662|Secondary|Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Body Weight|Change from Study Period III baseline to endpoint in body weight. Change = Endpoint minus baseline.|Week 2 and Week 12|Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5 - visit 9) visits.||kilograms||Standard Deviation|Mean
724308|NCT00337662|Secondary|Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Standing Systolic Blood Pressure|Change from Study Period III baseline to endpoint in standing systolic blood pressure. Change = Endpoint minus baseline.|Week 2 and Week 12|Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5 - visit 9) visits.||mm Hg||Standard Deviation|Mean
724309|NCT00337662|Secondary|Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Standing Pulse Rate|Change from Study Period III baseline to endpoint in standing pulse rate. Change = Endpoint minus baseline.|Week 2 and Week 12|Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5 - visit 9) visits.||beats per minute||Standard Deviation|Mean
724310|NCT00337662|Secondary|Vital Signs - Change From Baseline to 10 Week Endpoint in Standing Mean Arterial Pressure|Change from Study Period III baseline to endpoint in standing mean arterial pressure. Change = Endpoint minus baseline.|Week 2 and Week 12|Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5 - visit 9) visits.||mm Hg||Standard Deviation|Mean
724311|NCT00337662|Secondary|Vital Signs - Change From Baseline to 10 Week Endpoint in Standing Diastolic Blood Pressure|Change from Study Period III baseline to endpoint in standing blood pressure. Change = Endpoint minus baseline.|Week 2 and Week 12|Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5- visit 9) visits.||mm Hg||Standard Deviation|Mean
724312|NCT00337662|Secondary|Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Sitting Pulse Rate|Changes from Study Period III baseline to endpoint in sitting pulse rate. Change = Endpoint minus baseline.|Week 2 and Week 12|Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5 - visit 9) visits.||beats per minute||Standard Deviation|Mean
724313|NCT00337662|Secondary|Mean Change From Baseline to 10 Week Endpoint in Extrapyramidal Symptoms as Measured by the Abnormal Involuntary Movement Scale (AIMS)- Non-Global Total Score|A 12-item instrument assesses observed abnormal movements in different parts of body. Ten items are scored in a 5-point scale (0 = none/normal, 4 = severe) which evaluates abnormal movements in three main anatomic areas (orofacial area, extremities, and trunk). Two items are yes/no questions regarding dentures. Total scores range from 0 to 42.|Week 2 to Week 12|Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5 - visit 9) visits.||units on a scale||Standard Deviation|Mean
724314|NCT00337662|Secondary|Mean Change From Baseline to 10 Week Endpoint in Extrapyramidal Symptoms as Measured by the Barnes Akathisia Rating Scale - Total Score|Evaluates akathisia associated with use of antipsychotic medications, includes objective and subjective component plus global impression rating for overall disorder. Components rated on scale of 0 to 3 for objective and subjective items and 0 to 5 for global clinical assessment, for total score of 0 (absence of akathisia) to 11 (severe akathisia).|Week 2 to Week 12|Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5 - visit 9) visits.||units on a scale||Standard Deviation|Mean
724315|NCT00337662|Secondary|Mean Change From Baseline to 10 Week Endpoint in Extrapyramidal Symptoms as Measured by the Modified Simpson-Angus Scale|Measures neuroleptic-induced parkinsonism. Total score consists of the sum of 10 items: 7 items (items 1, 3, 4, 7, 8, 9, 10) rated on a 4-point severity scale where 0=normal and 4=extreme, and 3 items (items 2, 5, 6) rated on a 2-point severity scale where 0=normal and 2=definitely abnormal/present. The total score ranges from 0 to 34.|Week 2 to Week 12|Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5 - visit 9) visits.||units on a scale||Standard Deviation|Mean
724316|NCT00337662|Secondary|Number of Participants With Treatment-Emergent Abnormal Fasting Laboratory Analytes Reported in >=2% of All Participants|Number of participants who experienced abnormal fasting laboratory values at any time during Study Period III. Laboratory reference ranges are dependent on the patient's gender, origin, and age.|Week 2 to Week 12|Total number of patients with the lab test at baseline and post-baseline.||participants|||Number
724317|NCT00337662|Secondary|Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Body Mass Index|Body mass index is an estimate of body fat based on body weight divided by height squared. Change = Endpoint minus baseline.|Week 2 to Week 12|Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5 - visit 9) visits.||kilogram per square meter||Standard Deviation|Mean
724318|NCT00337662|Secondary|Number of Participants With Psychiatric Hospitalizations in the Early Onset and Not Early Onset-Risperidone Groups|Psychiatric Hospitalizations were measured by the Modified Schizophrenia Care and Assessment Program Health Questionnaire (SCAP-HQ) from which it could be determined the number of patients with a psychiatric episode that required an overnight stay in a hospital.|Week 2 to Week 12|Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5 - visit 9) visits.||participants|||Number
724319|NCT00337662|Secondary|Number of Participants in the Not Early Onset-Risperidone and Not Early Onset-Olanzapine Groups Who Show a 50% or Greater Reduction in Positive and Negative Syndrome Scale Total Score From Baseline or Meet 'a Priori' Specified Criteria for Remission|'a priori' specified criteria for remission defined as a score of 3 (mild), 2 (minimal), or 1 (absent) on all of the following 8 PANSS items: delusions, conceptual disorganization, hallucinatory behavior, unusual thought content, mannerisms and posturing, blunted effect, passive/apathetic withdrawal, lack of spontaneity and flow of conversation.|Week 2 to Week 12|Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5 - visit 9) visits.||participants|||Number
724320|NCT00337662|Secondary|Number of Participants in the Early Onset and Not Early Onset-Risperidone Groups Who Show a 50% or Greater Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score From Baseline or Meet 'a Priori' Specified Criteria for Remission|'a priori' specified criteria for remission defined as a score of 3 (mild), 2 (minimal), or 1 (absent) on all of the following 8 PANSS items: delusions, conceptual disorganization, hallucinatory behavior, unusual thought content, mannerisms and posturing, blunted effect, passive/apathetic withdrawal, lack of spontaneity and flow of conversation.|Week 0 to Week 12|Total number of patients having nonmissing values at both baseline (last of visit 1 - visit 2) and post baseline (last of visit 5 - visit 9) visits.||participants|||Number
724351|NCT00331760|Secondary|Overall Survival||From registration to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years.||||||
724321|NCT00337662|Secondary|The Number of Participants in the Not Early Onset-Risperidone (NEO-RIS) and Not Early Onset-Olanzapine (NEO-OLZ) Groups Who Show a 20% or Greater Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score|The number of not early onset participants who experienced a 20% or greater reduction in PANSS Total Score at any time during the 12 weeks of combined Study Period II and Study Period III.|Week 0 to Week 12|Total number of patients having nonmissing values at both baseline (last of visit 1 - visit 2) and post baseline (last of visit 5 - visit 9) visits.||participants|||Number
724322|NCT00337662|Secondary|The Number of Participants in the Early Onset (EO) and Not Early Onset-Risperidone (NEO-RIS) Groups Who Show a 20% or Greater Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score|The number of participants who experienced a 20% or greater reduction in their PANSS Total score during the 12 weeks they were on risperidone.|Week 0 to Week 12|Total number of patients having nonmissing values at both baseline (last of visit 1 - visit 2) and post baseline (last of visit 5 - visit 9) visits.||participants|||Number
724323|NCT00337662|Secondary|Changes From Study Period III Baseline (Week 2) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale Total Score in Not Early Onset Response-Risperidone and Not Early Onset Response-Olanzapine Patients|Assesses positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. Scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Sum of 30 items is PANSS total score and ranges from 30 to 210. Change = time point - double-blind baseline (Week 2).|Weeks 2, 3, 4, 6, 8, 12|Intention to treat patients with both baseline and postbaseline assessment||units on a scale||Standard Error|Least Squares Mean
724324|NCT00337662|Primary|Changes From Study Period II Baseline (Week 0) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale (PANSS) Total Score in Early Onset Response and Not Early Onset Response-Risperidone Patients|Assesses positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. Scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Sum of 30 items is PANSS total score and ranges from 30 to 210. Change = time point - single-blind baseline (Week 0).|Weeks 0, 3, 4, 6, 8, 12|Intention to treat for patients with both baseline and any postbaseline assessment||units on a scale||Standard Error|Least Squares Mean
724325|NCT00337675|Secondary|Daily Average of the Mean Symptom Scores (Wheeze, Difficulty Breathing, Interference With Activity, and Daytime Cough) Assessed Over the 12-day Treatment Period of Asthma Episodes|Each day during an asthma episode, the patient’s legal guardian was asked to rate each of the symptoms of Wheeze, Difficulty Breathing, Interference with Activity, and Daytime Cough on a 6-point scale (Scale 0 (best) to 5 (worst)). The average of the individual symptom scores on each of the 12 days of intermittent treatment for an episode (before the first attack) was reported. If a patient had multiple episodes over 1 year, the symptom scores were averaged across all the episodes.|1 Year|Patients with at least one episode culminating in an attack were included; therefore, 1120 patients were included in the analysis.||Units on a Scale||95% Confidence Interval|Least Squares Mean
724326|NCT00337675|Secondary|Daily Average of Wheeze and Difficulty Breathing in the 3 Days Prior to Start of an Asthma Attack Within an Asthma Episode|Each day during an asthma episode, the patient’s legal guardian was asked to rate each of the symptoms of wheeze and difficulty breathing on a 6-point scale (Scale 0 (best) to 5 (worst)). The average of the individual symptom scores on each of the 3 days prior to an asthma attack was reported. If a patient had multiple episodes during 1 year, the symptom scores were averaged across all the episodes.|1 Year|Only patients who experienced an asthma attack within an episode and did not start their intermittent study medication on the day of the attack could be included. Therefore, a total of 452 patients were included in this analysis.||Units on a Scale||95% Confidence Interval|Least Squares Mean
724327|NCT00337675|Primary|Number of Asthma Episodes Culminating in Asthma Attack Over the 1-year Treatment Period|The rate per year of asthma episodes culminating in an asthma attack for each of the 3 treatment groups. Asthma attacks were defined as respiratory symptoms requiring healthcare resource utilization (HRU), which comprised unscheduled visits to a physician or emergency department, treatment with corticosteroids (oral, rectal, or inhaled), or hospitalization. Each day during an episode, the patient’s legal guardian recorded all the HRU that was required specifically for breathing problems.|1-year treatment period|Full Analysis Set (FAS): all randomized patients who took at least one dose of blinded study drug. Of 1771 patients randomized, 5 never took study drug and 9 were not included due to Good Clinical Practice compliance concerns. Therefore, 1757 patients were included in the FAS population.||Asthma attacks within episodes per year||95% Confidence Interval|Mean
724328|NCT00337727|Secondary|Number of Patients Who Reported Complete Response|The number of patients who reported Complete Response (no vomiting and no use of rescue medication) in the overall phase in Cycle 1.|Overall phase (0-120 hours post initiation of MEC) in Cycle 1|FAS (full analysis set) patient population was used for all efficacy evaluations and included patients who (1) received MEC, (2) took a dose of study drug, and (3) completed at least one post treatment efficacy assessment.||Participants|||Number
724329|NCT00337727|Primary|Number of Patients Who Reported No Vomiting|"The number of patients who reported No Vomiting in the overall phase in Cycle
1"|Overall phase (0-120 hours post initiation of MEC) in Cycle 1.|FAS (full analysis set) patient population was used for all efficacy evaluations and included patients who (1) received Moderately Emetogenic Chemotherapy (MEC), (2) took a dose of study drug, and (3) completed at least one post treatment efficacy assessment.||Participants|||Number
724330|NCT00337779|Secondary|The Cumulative Number of T1-Gd Enhancing Lesions at Months 3, 6, 9 and 12 (in the Frequent MRI Cohort-described Below).|"The Frequent MRI Cohort was a subset of subjects consisting of 234 subjects, for whom MRI scans were performed at months 0 (baseline), 1, 2, 3, 6, 9 and 12. Analysis of the endpoint was based on the outcome of a contrast derived from a baseline-adjusted Negative Binomial Regression with an offset variable employing the log of the porportion of the number of available post-baseline scans to adjust for missing MRI scans (if any) and including the number of T1 Gd-enhancing lesions at baseline and (pooled) center as covariates."|12 months|Frequent MRI cohort||T1 Enhancing Lesions||Standard Deviation|Log Mean
724331|NCT00337779|Secondary|The Number of New T2 Lesions at Month 12 as Compared to the Baseline Scan.|The analysis of this endpoint was based on the outcome of a contrast derived from a baseline-adjusted Negative Binomial Regression including the number of T1 Gd-enhancing lesions at baseline, the volume of T2 lesions at baseline and (pooled) center as covariates.|12 months|||T2 Lesions||Standard Deviation|Mean
724332|NCT00337779|Primary|The Rate of Confirmed Relapses During the Double-blind Phase (12 Months).|A confirmed relapse is defined as the appearance of one or more new neurological abnormalities or the reappearance of one or more previously observed neurological abnormalities. This change in clinical state must last at least 48 hours and be immediately preceded by an improving neurological state of at least thirty (30) days from onset of previous relapse.|12 months|ITT||Number of relapses per patient||Standard Deviation|Mean
724333|NCT00337818|Secondary|Number of Subjects Reporting SAEs|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Throughout the study period (up to Month 48)|Analysis was performed on the Total vaccinated cohort of each time point.||Subjects|||Number
724334|NCT00337818|Secondary|Number of Subjects Reporting Pregnancies, New Onset Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs)|NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes. MSCs assessed include adverse events prompting emergency room or physician visits that are not related to common diseases or serious adverse events (SAEs) that are not related to common diseases.|Throughout the study period (up to Month 48)|Analysis was performed on the Total vaccinated cohort for Month 24, Month 36 and Month 48, respectively.||Subjects|||Number
724335|NCT00337818|Secondary|Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies in Blood Samples|Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL.|At Months 24, 36 and 48|Analysis was performed on the Total Vaccinated Cohort, on subjects with cervicovaginal secretion sample results available and with cervicovaginal secretion samples having less than 200 erythrocytes per milliliter and with results available for the defined timepoint.||EL.U/mL||95% Confidence Interval|Geometric Mean
724336|NCT00337818|Secondary|Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervical Samples|Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL.|At months 24, 36, and 48|Analysis was performed on the ATP cohort for analysis of immunogenicity, in post-menarcheal subjects who volunteered for cervicovaginal sampling collection and with cervicovaginal secretion samples having less than 80 erythrocytes per milliliter and with results available for the defined timepoint.||EL.U/mL||95% Confidence Interval|Geometric Mean
724337|NCT00337818|Primary|Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies|"Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).
*Data for Month 18 outcome variables were incorporated into the Month 24 analyses."|At months 18*, 24, 36 and 48|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data for the defined timepoint.||EL.U/mL||95% Confidence Interval|Geometric Mean
724338|NCT00337935|Secondary|Time to Hemoglobin Response|Time to hemoglobin reponse was defined as the time between individual treatment start date and the first of 2 consecutive hemoglobin measurements at least 1.0 g/dL above baseline or 2 consecutive hemoglobin measurements at least 11.0 g/dL. Note: Upper 95% confidence limit for the Standard of Care Group was not estimable because an insufficient number of participates reached the event at the final time point for assessment.|Week 0 to Week 26|Modified intent to treat (mITT) - all subjects with at least 1 hemoglobin measurement after baseline. Four subjects did not have hemoglobin measurement post baseline.||Days||95% Confidence Interval|Median
724339|NCT00337935|Secondary|The Number of Patients Achieved a Hemoglobin Response.|Hemoglobin reponse was defined as 2 consecutive hemoglobin measurements at least 1.0 g/dL above baseline or 2 consecutive hemoglobin measurements at least 11.0 g/dL|Week 0 to Week 26|Modified intent to treat (mITT) - all subjects with at least 1 hemoglobin measurement after baseline. Four subjects did not have hemoglobin measurement post baseline.||participants|||Number
724340|NCT00337935|Primary|Mean Change in Hemoglobin Level From Baseline to the End of Study (26 Weeks)||Week 0 to Week 26|Modified intent to treat (mITT) - all subjects with at least 1 hemoglobin measurement after baseline. Four subjects did not have hemoglobin measurement post baseline.||g/dL||Standard Deviation|Mean
724341|NCT00337987|Primary|Number of Patients That Achieved a Complete Response (CR)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|After 4 years|||participants|||Number
724342|NCT00337987|Primary|Number of Patients That Achieved a Complete Response or a Partial Response (PR)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|After 4 years|||participants|||Number
724343|NCT00338039|Primary|Median Overall Survival|Median survival is defined as the time of initiation of the first dose of chemotherapy to the date of death.|Baseline to disease progression or death, up to 4 years|||Months||95% Confidence Interval|Median
724344|NCT00338039|Primary|Overall Survival Rate|1-year, 2-year, and 4-year actuarial overall survival (OS) rates defined as number of participants out of total participants alive at 1, 2 or 4 years post baseline treatment.|1 to 4 years|||percentage of participants|||Number
724345|NCT00338104|Secondary|Percentage of Glucose Levels > 180 mg/dL|Percentage of blood glucose levels > 180 mg/dL|First 24 hours after conversion|||percentage of blood glucose values|||Number
724346|NCT00338104|Secondary|Percentage of Glucose Values < 50 mg/dL|Percentage of blood glucose values < 50 mg/dL|First 24 hours after conversion|||percentage of blood glucose values|||Number
724347|NCT00338104|Primary|Percentage of Blood Glucose Values Between 80 - 140|Percentage of blood glucose values within the target range of eighty to one hundred forty mg per dL|First 24 hours after conversion|||percentage of blood glucose values|||Number
724348|NCT00331682|Secondary|Overall Survival|Will be computed using Kaplan-Meier methods.|Between the start of treatment until patient death, assessed up to 2 years|||months||Full Range|Median
724349|NCT00331682|Secondary|Time to Progression|Will be computed using Kaplan-Meier methods.|Between the start of treatment until the criteria for progression are met, assessed up to 2 years|||weeks||Full Range|Median
724350|NCT00331682|Primary|Objective Response Rate as Measured by RECIST Criteria|Objective response rate as measured by RECIST criteria|Up to 2 years|||participants|||Number
724358|NCT00331760|Primary|Reproducibility of Radiation Technique (Number of Unacceptable Deviations in Central IMRT Quality Assurance Review)|"Central quality assurance review of the IMRT planning and dosing categorized unacceptable deviations (UD) from protocol compliance with the delineation of planning target volume for the vagina and pelvic lymph nodes. Each arm of this study is considered independently, they are not compared to each other. The study was designed such that, for each arm, 5 or more of 42 subjects scored as unacceptable would determine the respective treatment technique as not reproducible. For each arm this design provides 90% power with a 0.05 type I error to reject the null hypothesis that the true probability of concluding the given technique to be reproducible is <= 80%. The alternative hypothesis is that the true probability is >= 95%.
For [vagina / pelvic lymph nodes]: UD is defined as: The 90% isodose surface covers < 95% of [internal target volume (ITV)/ planned target volume (PTV)] 50.4 or > 5% of the [ITV/PTV] 50.4 receives over 115%."|IMRT planning and dosing data is centrally reviewed for quality assurance after treatment delivery.|All eligible patients.||participants|||Number
724359|NCT00331773|Other Pre-specified|Collection of Paraffin-embedded Tissue Block, Serum, Plasma, and Buffy Coat Cells for Future Translational Research Analyses||From baseline to 5 years from the start of treatment.||||||
724360|NCT00331773|Secondary|Statistical Modeling of Genomic Biomarkers|Biomarker data has not been obtained yet therefore this analysis has not occurred.|Baseline biomarker collection will be used. Analysis occurs after the primary endpoint analysis.||||||
724361|NCT00331773|Secondary|Assessment of Trade-off Between Disease-free Survival and Quality of Life.|To examine trade-offs between the survival time and QOL, we were to combine them for each patient into two single measurements: quality adjusted live year (QALY) and quality adjusted disease-free survival year (QADFSY). We were to use Glasziou‘s multiple health-state (Q-TWiST) models to use the repeated measures of EQ-5D. This analysis was not conducted because there were no differences in EQ-5D scores. See results presented for Outcome Measure 10: Evaluation and Comparison of the Cost-utility of Each Treatment Arm Using EQ-5D.|From baseline to 5 years from the start of treatment||||||
724362|NCT00331773|Secondary|EQ-5D Scores|The EQ-5D is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 3 problem levels (1-none, 2-moderate, 3-extreme). Health states are defined by the combination of the leveled responses to the 5 dimensions, generating 243 health states to which unconsciousness and death are added. The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm 10-point interval scale. Worst imaginable health state is scored as 0 at the bottom of the scale, and best imaginable health state is scored as 100 at the top. Both the 5-item index score and the VAS score are transformed into a utility score between 0 ―Worst health stat and 1 ―Best health state. A two-sided Wilcoxon test with alpha 0.05 was used due to the skewed, thus non-normal, nature of the data.|Baseline, 6 months, 12 months, 24 months, and 5 years|Eligible patients with a baseline or follow-up EQ-5D score who did not withdraw consent||units on a scale||Inter-Quartile Range|Median
724363|NCT00331773|Secondary|Change From Baseline in Assessment of Anxiety and Depression Using the HSCL-25|Anxiety and depression were measured with the Hopkins Symptom Checklist (HSCL-25). It consists of 25 items: Part I of the HSCL-25 has 10 items for anxiety symptoms; Part II has 15 items for depression symptoms. The scale for each question includes four categories of response (“Not at all,” “A little,” “Quite a bit,” “Extremely,” rated 1 to 4, respectively). Two scores are calculated: the total score is the average of all 25 items and ranges from 0 to 100. A higher score indicates worse symptoms. The HSCL-25 tool was assessed at baseline, 6 months, 12 months, 24 months, and 5 years. For each patient, the change in score from baseline to the time point is calculated by subtracting the baseline value from the time point value.|Baseline, 6 months, 12 months, 24 months, and 5 years|Eligible patients with a follow-up HSCL-25 who did not withdraw consent||units on a scale||Standard Deviation|Mean
724364|NCT00331773|Secondary|The Utilization of Sexual Medications/Devices Questionaire|"The Utilization of Sexual Medications/Devices questionaire is designed to assess the use of erectile aids among patients treated for prostate cancer. This instrument is used to complement the sexual symptom domain in the EPIC. The percentage of Yes responses to the following questions are reported: Do you have a penile prosthesis, Have you used an medications or devices to aid or improve erections?."|Baseline, 6, 12, and 24 months, and 5 years|Eligible patients answering the questionaire, who did not withdraw consent||percentage of participants|||Number
724365|NCT00331773|Secondary|Comparison of Disease-specific HRQOL Change in Expanded Prostate Cancer Index Composite (EPIC); the Utilization of Sexual Medications/Devices Supplements the EPIC|Prostate cancer (PC) Health-Related Quality of Life (HRQOL) outcomes as measured by change over time in the Expanded Prostate Cancer Index Composite [EPIC], a PC HRQOL instrument measuring a broad spectrum of urinary, bowel, and sexual symptoms related to radiotherapy, is compared between arms. The EPIC questionnaire was grouped into four domains (bowel, urinary, sexual, hormonal), each with a score ranging from 0 (worst) to 100 (best), and was assessed at baseline, 6, 12, and 24 months, and 5 years. The difference in score from baseline to each time point was calculated and the Wilcoxon test statistic was used to test the null hypothesis that responses are the same across the two treatment arms vs. the alternative hypothesis that they are different, using a 2-sided alpha of 0.05 at each timepoint, resulting in an alpha of 0.0125 for each domain. Each row refers to a separate analysis.|Baseline, 6, 12, and 24 months, and 5 years|Eligible patients with both a baseline and follow-up EPIC domain score, who did not withdraw consent||units on a scale||Standard Deviation|Mean
724366|NCT00331773|Secondary|Frequency of Patients With GU and GI Acute and Late Toxicity|The frequency of genitourinary (GU) and gastrointestinal (GI) adverse events as defined and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 3) were compared between treatment arms. Acute toxicity was defined as any toxicity beginning within 90 days of completion of RT, and late toxicity was defined as any toxicity beginning more than 90 days after the completion of RT. Acute and late GU and GI toxicity rates were tabulated and reported in two ways: dichotomized as < grade 2 vs ≥ grade 2, and dichotomized as < grade 3 vs ≥ grade 3. Higher grade indicates more severity.|Acute toxicity is measured from start of treatment to 90 days from the completion of treatment. Late toxicity is defined as toxicity occuring after 90 days from completion of treatment. Analysis occured at the time of the primary endpoint analysis.|All eligible patients who started study treatment and did not withdraw consent||participants|||Number
725150|NCT00344019|Secondary|Post PCI Growth of Tissue Level Perfusion Circumference and Brightness Using Digital Subtraction Angiography|No data was analyzed due to small numbers. Collected data no longer available as retention period has passed|24 hours||||||
724367|NCT00331773|Secondary|Five-year Overall Survival Rate|Five-year rates Kaplan-Meier estimates. Overall survival (OS) was measured from study entry until the date of death. Patients still alive at the time of analysis were censored at the date of last follow-up|Analysis occurs after all patients have been followed for five years.|Eligible patients who did not withdraw consent.||percentage of participants||95% Confidence Interval|Number
724368|NCT00331773|Secondary|Five-year PSA Failure Rate|"Five-year rates are shown (cumulative incidence estimates). Note, although the protocol calls this endpoint Freedom from biochemical recurrence, it defines the endpoint as The time to PSA failure. An event for PSA, i.e. biochemical, failure was the first of the following: initiation of non-protocol (e.g., salvage) hormone therapy, or an increase in PSA of at least 2 ng/dl. Time to biochemical failure was measured from study entry until the date of failure."|Analysis occurs after all patients have been followed for five years.|Eligible patients who did not withdraw consent.||percentage of participants||95% Confidence Interval|Number
724369|NCT00331773|Secondary|Five-year Disease-specific Survival Rate|"An event was death in association with any of the following conditions:
Primary cause of death certified as due to prostate cancer
Further clinical tumor progression occurring after initiation of salvage anti-tumor (e.g., (androgen suppression) therapy
A rise (that exceeds 1.0 ng/mL) in the serum prostate-specific antigen (PSA) level on at least two consecutive occasions that occurs during or after salvage androgen suppression therapy
Disease progression in the absence of any anti-tumor therapy
Death from a complication of therapy, irrespective of disease status. The arms were not statistically compared because of an insufficient number of events."|Analysis occurs after all patients have been followed for five years.|All eligible patients||percentage of participants||95% Confidence Interval|Number
724370|NCT00331773|Secondary|Five-year Local Progression Rate|Clinical criteria for local recurrence are progression (increase in palpable abnormality) at any time, failure of regression of the palpable tumor by 2 years, and redevelopment of a palpable abnormality after complete disappearance of previous abnormalities. Histologic criteria for local recurrence are presence of prostatic carcinoma upon biopsy and positive biopsy of the palpably normal prostate more than 2 years after the start of treatment. The arms were not statistically compared because of an insufficient number of events.|Analysis occurs after all patients have been followed for five years.|All eligible patients.||percentage of participants||95% Confidence Interval|Number
724371|NCT00331773|Primary|Five-year Disease-free Survival (DFS) Rate|Five-year rates are estimated by the Kaplan-Meier method. DFS events included local progression, distant metastatic progression, biochemical recurrence as defined by the Radiation Therapy Oncology Group (RTOG) Phoenix definition, or death from any cause. Patients who experienced second primary cancers remained under observation for DFS events.|Analysis occurs after all patients have been followed for five years.|Eligible patients who did not withdraw consent||percentage of participants||95% Confidence Interval|Number
724372|NCT00331799|Primary|Change in Connor Davidson Resilience Scale (CD-RISC) From Baseline to 8 Weeks|CD-RISC has been psychometrically validated, studied in the general population, as well as in clinical samples. Changes in CD-RISC score have been found to be sensitive to the effect of treatment, and impaired resilience has been demonstrated in subjects with depression relative to normal controls using this scale (Connor and Davidson, 2003). The total score ranges from 0-100, with higher scores indicating greater resilience.|baseline and 8 weeks|||units on a scale||Standard Deviation|Mean
724373|NCT00331864|Primary|Percentage of Patients With Targeted Grade 3 Adverse Events (AEs) in the Study Eye|"Grade 3 targeted AEs included:
4+ ocular inflammation or 2–3+ ocular inflammation failing to decrease to ≤ 1+ within 30 days
≥ 30 letter decrease in BCVA that developed within 14 days of ranibizumab injection
sustained (>15 minutes) loss of light perception due to elevated intraocular pressure (IOP) or a >20 mm Hg change in IOP persisting longer than 14 days
new retinal tear or detachment involving the macula
new vitreous hemorrhage >2+ severity not resolving within 14 days
new or increase of previous retinal hemorrhage >1 disc area in size and involving the fovea"|Baseline through end of study (12 month treatment period)|For Non-ANCHOR treatment group, the analysis population was the Safety population: All patients who had received at least one application of study drug and had at least one post-baseline safety assessment. For the ANCHOR treatment group, the analysis population was all enrolled patients.||Percentage of Participants|||Number
724374|NCT00331864|Secondary|Total Number of Treatments|Total number of treatments administered during the entire treatment period (Month 0 to 11).|Baseline (Month 0) to Month 11|For Non-ANCHOR treatment group, the analysis population was the Safety population: All patients who had received at least one application of study drug and had at least one post-baseline safety assessment. For the ANCHOR treatment group, the analysis population was all enrolled patients.||Treatments||Standard Deviation|Mean
724375|NCT00331864|Secondary|Time to the First Retreatment After Month 2|"Time to first re-treatment is calculated as time difference in months starting from Month 2 until the month of first re-treatment.
Criteria for re-treatment:
a >5 letter decrease in BCVA (determined using EDRS charts) based upon the highest visual acuity score from any prior scheduled study visit (Months 0, 1, 2 or 3)
a >100 µm increase in central retinal thickness (determined using OCT) from the thinnest measurement from any prior scheduled study visit (Months 0, 1, 2 or 3)"|Month 2 to Month 11|Intent-to-Treat (ITT) population patients: All patients who received study drug at least once and had at least one post-baseline efficacy assessment. The ANCHOR patients were not included in this analysis.||Months||Inter-Quartile Range|Median
724376|NCT00331864|Secondary|Mean Change in Central Retinal Thickness of the Study Eye From Baseline to Month 12|Central retinal thickness was assessed using optical coherence tomography (OCT). OCT imaging was performed by trained personnel at each site using the Zeiss Stratus OCT™ 3 with version A6.1 (or more recent) software. Analysis of the OCT images was performed by the investigator. A negative number indicates improvement (reduced thickness).|Baseline and Month 12|Non-ANCHOR patients: Analysis of Intent-to-Treat (ITT) population (all patients who received study drug at least once and had at least one post-baseline efficacy assessment) using last observation carried forward (LOCF). ANCHOR patients: Analysis of All Enrolled population (all enrolled patients) using LOCF.||Micrometers||Standard Deviation|Mean
724421|NCT00332696|Secondary|Number of Participants With Relief From Obstruction at Day 7 and Day 14|Relief from obstruction is defined by combining restart of stools for at least the previous 3 days, less than 2 episodes of vomiting on average for the previous 4 days and the restarting of flatus (gas generated in the stomach or bowels) for at least the previous 12 hours.|Day 7 and Day 14|Intent-to-treat population consisted of all randomized participants who received at least one dose of study drug.||Participants|||Number
724377|NCT00331864|Secondary|Mean Change in Central Retinal Thickness of the Study Eye From Baseline to Month 3|Central retinal thickness was assessed using optical coherence tomography (OCT). OCT imaging was performed by trained personnel at each site using the Zeiss Stratus OCT™ 3 with version A6.1 (or more recent) software. Analysis of the OCT images was performed by the investigator. A negative number indicates improvement (reduced thickness).|Baseline and Month 3|Non-ANCHOR patients: Analysis of Intent-to-Treat (ITT) population (all patients who received study drug at least once and had at least one post-baseline efficacy assessment) using last observation carried forward (LOCF). ANCHOR patients: Analysis of All Enrolled population (all enrolled patients) using LOCF.||Micrometers||Standard Deviation|Mean
724378|NCT00331864|Secondary|Mean Change in Best Corrected Visual Acuity (BCVA) of the Study Eye From Baseline to Month 12|"BCVA was assessed using best correction determined from protocol refraction. BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at an initial testing distance of 4 meters.
BCVA is measured by the number of letters a patient could correctly read on an eye chart; hence an increased score indicates improvement in acuity."|Baseline and Month 12|Non-ANCHOR patients: Analysis of Intent-to-Treat (ITT) population (all patients who received study drug at least once and had at least one post-baseline efficacy assessment) using last observation carried forward (LOCF). ANCHOR patients: Analysis of All Enrolled population (all enrolled patients) using LOCF.||Letters on the ETDRS-like testing charts||Standard Deviation|Mean
724379|NCT00331864|Secondary|Mean Change in Best Corrected Visual Acuity (BCVA) of the Study Eye From Baseline to Month 3|"BCVA was assessed using best correction determined from protocol refraction. BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at an initial testing distance of 4 meters.
BCVA is measured by the number of letters a patient could correctly read on an eye chart; hence an increased score indicates improvement in acuity."|Baseline and Month 3|Non-ANCHOR patients: Analysis of Intent-to-Treat (ITT) population (all patients who received study drug at least once and had at least one post-baseline efficacy assessment) using last observation carried forward (LOCF). ANCHOR patients: Analysis of All Enrolled population (all enrolled patients) using LOCF.||Letters on the ETDRS-like testing charts||Standard Deviation|Mean
724380|NCT00331864|Primary|Percentage of Patients With Ocular Adverse Events (AEs) in the Study Eye|Percentage of patients with ocular adverse events in the study eye over the one year (12 month) treatment period.|Baseline through end of study (12 month treatment period)|For Non-ANCHOR treatment group, the analysis population was the Safety population: All patients who had received at least one application of study drug and had at least one post-baseline safety assessment. For the ANCHOR treatment group, the analysis population was all enrolled patients.||Percentage of Participants|||Number
724381|NCT00332163|Secondary|Change From Baseline in Overall Dermatologic Quality of Life Index (DLQI) Score|Skin-related quality of life was assessed using the DLQI. The DLQI questionnaire asks participants to evaluate the degree that their skin condition has affected their quality of life in the last week. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); The DLQI score is calculated by summing the scores for all questions, resulting in a maximum of 30 and a minimum of 0; higher scores indicate a more impaired quality of life.|Baseline and Weeks 2, 3, 4, 5, 6 and 7|Patient Reported Outcomes (PRO) Analysis Set (randomized participants who signed informed consent before protocol-specified procedures, received at least 1 dose of panitumumab, with a non-missing baseline overall DLQI score and who had at least 1 post-baseline non-missing overall DLQI score) with available data at each time point.||units on a scale||Standard Deviation|Mean
724382|NCT00332163|Secondary|Progression-free Survival|Defined as the time from the date of randomization to the first date of observed disease progression or death due to any cause (whichever comes first). Participants who were alive and had not progressed while on study were censored at the date of last progression-free tumor assessment.|From randomization until the end of study; median time on study was 31 weeks and 41 weeks in each treatment group respectively with a maximum time on study of 97 weeks.|Primary Analysis Set||months||95% Confidence Interval|Median
724383|NCT00332163|Secondary|Overall Survival|Overall Survival is defined as the time from the date of randomization to the date of death. Participants who did not die while on study or who were lost-to-follow-up were censored at their last contact date. Overall survival was analyzed using all data regardless of whether it was collected during second- or third-line treatment.|From randomization until the end of study; median time on study was 31 weeks and 41 weeks in each treatment group respectively with a maximum time on study of 97 weeks.|Primary Analysis Set||months||95% Confidence Interval|Median
724384|NCT00332163|Secondary|Time to Progression|"Time from the date of randomization to the date of observed disease progression or death due to disease progression. Participants who did not have documented disease progression were censored at the date of last tumor assessment; participants who died for reasons other than disease progression while on study were censored at the date of death. PD: At least a 20% increase in the size of target lesions, recorded since the treatment started, or at least a 25% increase in size of non-target lesions and the lesion(s) measure > 10 mm in one dimension, or the appearance of one or more new lesions.
Time to progression was analyzed using the Kaplan-Meier method. This analysis excludes any data collected during follow-up for participants who began third-line treatment."|From randomization until the end of study; median time on study was 31 weeks and 41 weeks in each treatment group respectively with a maximum time on study of 97 weeks.|Primary Analysis Set||months||95% Confidence Interval|Median
724385|NCT00332163|Secondary|Time to Treatment Failure|Time-to-treatment failure is defined as the time from the date of randomization to the first date of any of the following events: discontinuation of study therapy due to any reason (except for complete response and curative surgery), progression of disease, or death due to any cause. Participants who did not discontinue, who were still alive, and who did not have disease progression were censored at the date of last contact. Time to treatment failure was analyzed using the Kaplan-Meier method.|From randomization until the end of study; median time on study was 31 weeks and 41 weeks in each treatment group respectively with a maximum time on study of 97 weeks.|Primary Analysis Set||months||95% Confidence Interval|Median
724644|NCT00345878|Secondary|Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies|Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).|At Month 0 and Month 7|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.||EL.U/mL||95% Confidence Interval|Geometric Mean
724386|NCT00332163|Secondary|Rate of Disease Control at First Scheduled Assessment|Tumor response was assessed by CT scan or MRI of the abdomen, pelvis, and all other sites of disease. Disease assessments were performed by central review according to the modified response evaluation criteria in solid tumors (RECIST). Disease control rate is defined as the percentage of participants with a CR, PR or stable disease (SD) at the Week 9/10 assessment visit and a corresponding response (CR or PR) confirmed at the Week 13/14 assessment visit for the Q2W/Q3W regimens. SD: Neither sufficient shrinkage or increase in target lesions to qualify for PR or PD, with no progression of non-target lesions and no new lesions.|Week 9 with confirmed response at Week 13 for the FOLFIRI and panitumumab Q2W regimen or at Week 10 with confirmed response at Week 14 for the irinotecan and panitumumab Q3W regimen.|Primary Analysis Set; participants who prematurely discontinued without a postbaseline tumor assessment or with an observed CR or PR at Week 9 or 10 that was not confirmed at Week 13 or 14 were considered non-responders.||percentage of participants||95% Confidence Interval|Number
724387|NCT00332163|Secondary|Best Overall Response Rate|Best overall response rate is defined as the percentage of participants with a complete response (CR) or partial response (PR) while on study. Tumor response was assessed by CT scan or MRI of the abdomen, pelvis, and all other sites of disease. Disease assessments were performed by central review according to the modified RECIST criteria. CR: Disappearance of all target and non-target lesions and no new lesions. PR: Either the disappearance of all target lesions with persistence of one or more non-target lesion(s) not qualifying for either CR or PD (≥ 25% increase in lesion size) and no new lesions, or, at least a 30% decrease in the size of target lesions with no progression of existing non-target lesions, and no new lesions.|Response was assessed at Weeks 9 and 13 and then every 8 weeks for the Q2W regimen, or at Weeks 10, 14, 22 and then every 9 weeks for the Q3W regimen until the end of treatment; median treatment duration was 13 and 17 weeks in each group respectively.|Primary Analysis Set; participants who prematurely discontinued without a post-baseline tumor assessment or with an observed CR or PR that was not confirmed were considered non-responders.||percentage of participants||95% Confidence Interval|Number
724388|NCT00332163|Secondary|Response Rate at First Scheduled Assessment|Tumor response was assessed by computed tomography (CT) scan or magnetic resonance imaging (MRI) of the abdomen, pelvis, and all other sites of disease. Disease assessments were performed by central review according to the modified response evaluation criteria in solid tumors (RECIST). Response rate is defined as the percentage of participants with a complete response (CR) or partial response (PR) at the Week 9/10 assessment visit and a corresponding CR or PR confirmed at the Week 13/14 assessment visit for the Q2W/Q3W regimens. CR: Disappearance of all target and non-target lesions and no new lesions. PR: Either the disappearance of all target lesions with persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease (PD; ≥ 25% increase in lesion size) and no new lesions, or, at least a 30% decrease in the size of target lesions with no progression of existing non-target lesions, and no new lesions.|Week 9 with confirmed response at Week 13 for the FOLFIRI and panitumumab Q2W regimen or at Week 10 with confirmed response at Week 14 for the irinotecan and panitumumab Q3W regimen.|Primary Analysis Set; participants who discontinued prematurely without a post-baseline tumor assessment or with an observed CR or PR at Week 9 or 10 that was not confirmed at Week 13/14 were considered non-responders.||percentage of participants||95% Confidence Interval|Number
724389|NCT00332163|Secondary|Percentage of Participants With Panitumumab Dose Reductions Due to the Specific Skin Toxicities of Interest||6 weeks|Primary Analysis Set||percentage of participants||95% Confidence Interval|Number
724390|NCT00332163|Secondary|Time to First Most Severe Specific Grade 2 or Higher Skin Toxicities of Interest|Time to the first most severe grade ≥ 2 of all the specific skin-related toxicities of interest was defined as the time from the first dose of panitumumab to the date of the first occurrence of the most severe specific ≥ grade 2 skin toxicity of interest during the 6-week skin treatment period. Participants who did not experience any specific skin-related toxicity of grade ≥ 2 were censored at their last skin toxicity assessment during the 6-week skin toxicity assessment period. Skin toxicities were assessed by the study clinician and graded according to the modified CTCAE v.3.0 Dermatology Toxicity Grading criteria, on a scale from Grade 1 (mild) to 4 (life-threatening). The specific skin toxicities of interest were pruritus, acneiform dermatitis, skin desquamation (also described as skin exfoliation), exfoliative dermatitis, paronychia, nail disorder, skin fissures, skin laceration, pruritic rash, pustular rash, skin infection, skin ulceration, and local infection.|6 weeks|Primary Analysis Set||weeks||95% Confidence Interval|Median
724391|NCT00332163|Secondary|Most Severe Specific Grade 2 or Higher Skin Toxicities of Interest|The percentage of participants with a most severe grade of 2, 3 or 4 specific skin toxicity of interest reported during the 6-week skin treatment period. Skin toxicities were assessed by the study clinician and graded according to the modified CTCAE v.3.0 Dermatology Toxicity Grading criteria, on a scale from Grade 1 (mild) to 4 (life-threatening). The specific skin toxicities of interest were pruritus, acneiform dermatitis, skin desquamation (also described as skin exfoliation), exfoliative dermatitis, paronychia, nail disorder, skin fissures, skin laceration, pruritic rash, pustular rash, skin infection, skin ulceration, and local infection.|6 weeks|Primary Analysis Set||percentage of participants||95% Confidence Interval|Number
724392|NCT00332163|Secondary|Time to First Occurrence of Specific Grade 2 or Higher Skin Toxicities of Interest|The time to the first occurrence of specific grade 2 or higher skin toxicities of interest was defined as the time from the first dose of panitumumab to the date of first occurrence of specific ≥ grade 2 skin toxicities of interest. Participants who did not experience specific skin-related toxicities were censored at their last skin toxicity assessment during the skin toxicity assessment period. Skin toxicities were assessed by the study clinician and graded according to the modified CTCAE v.3.0 Dermatology Toxicity Grading criteria, on a scale from Grade 1 (mild) to 4 (life-threatening). The specific skin toxicities of interest were pruritus, acneiform dermatitis, skin desquamation (also described as skin exfoliation), exfoliative dermatitis, paronychia, nail disorder, skin fissures, skin laceration, pruritic rash, pustular rash, skin infection, skin ulceration, and local infection.|6 weeks|Primary Analysis Set||weeks||95% Confidence Interval|Median
724422|NCT00332696|Secondary|Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 14|Participants rated their nausea intensity on a scale of 0 to 3, with 3 being the worse. The number of participants with a score of 0, a score of 1, a score of 2 and a score of 3 are presented for Day 14.|Day 14|Participants from the Intent-to-treat population consisting of all randomized participants who received study drug and for whom data was available at Day 14.||Participants|||Number
724393|NCT00332163|Secondary|Percentage of Participants With Any Grade 2 or Higher Skin Toxicity of Any Type During the 6-week Skin Treatment Period|The percentage of participants who developed at least 1 incidence of ≥ grade 2 skin toxicities of any type during the 6-week skin treatment period. Analysis of this endpoint was based on adverse event data associated with the “Skin and Subcutaneous Tissue Disorders” system organ class. Adverse events were graded according to the National Cancer Institute (NCI) CTCAE version 3.0.|6 weeks|Primary Analysis Set||percentage of participants||95% Confidence Interval|Number
724394|NCT00332163|Primary|Percentage of Participants With Specific Grade 2 or Higher Skin Toxicities During the 6-week Skin Treatment Period|Skin toxicities were assessed by the study clinician and graded according to the modified Common Toxicity Criteria for Adverse Events (CTCAE) v.3.0 Dermatology Toxicity Grading criteria, on a scale from Grade 1 (mild) to 4 (life-threatening). The specific skin toxicities of interest were pruritus, acneiform dermatitis, skin desquamation (also described as skin exfoliation), exfoliative dermatitis, paronychia, nail disorder, skin fissures, skin laceration, pruritic rash, pustular rash, skin infection, skin ulceration, and local infection.|6 weeks|Primary analysis set (all randomized participants who provided informed consent before protocol-specific procedures and who received at least 1 dose of panitumumab)||percentage of participants||95% Confidence Interval|Number
724395|NCT00332189|Secondary|Following Blood Phe Levels.|There were no pre-specified efficacy analysis, blood Phe samples were taken at each visit. Blood Phe concentrations remained within levels consistent with local clinical site recommendations for blood Phe control.|Baseline through Final Visit (a Maximum of 30 months) with blood phe samples taken at months 3 and 6 then at 6 month intervals|The population includes all subjects who received at least one dose of study drug during the study and had at least one measurement of blood Phe level.||micromoles per liter||Standard Deviation|Mean
724396|NCT00332189|Primary|Tabulation of the Incidence and Frequency of All AEs and SAEs That Occur Throughout the Study.|Safety was assessed with regards to the rate and type of AEs, clinically significant changes to vital signs and/or physical examination findings, and clinically significant changes in laboratory test results.|Baseline through Final Visit (a Maximum of 30 months) with AEs collected at month 3 and 6 then at 6 month intervals|Percentage of total population who experienced an AE or SAE presented here. For full list of SAEs, and AEs experienced with a frequency of greater than 5%, see the Reported Adverse Event section.||percentage of subjects reporting events|||Number
724397|NCT00332241|Secondary|Change From Baseline in Body Weight|Adjusted mean change (Week 8 - baseline) in body weight|Week 8|Safety population=all randomized participants minus 1 patient in the placebo group lost to follow-up. Includes all participants with weight measurement at baseline and timepoint. Data set is LOCF.||kilograms||Standard Error|Mean
724398|NCT00332241|Secondary|Summary of Safety|Deaths, Adverse Events (AEs), Serious AEs (SAEs), Treatment-Emergent AEs and AEs leading to discontinuation|continuous throughout the study|Safety population=all randomized participants minus 1 patient in the placebo group lost to follow-up. Data set is LOCF.||participants|||Number
724399|NCT00332241|Secondary|Mean Change (Week 8 - Baseline) in CGI-Severity (CGI-S)|A CGI-S assessment (a 7-point scale to evaluate the severity of symptoms) was performed at baseline (1=no symptoms; 7=very severe symptoms). The patient’s improvement relative to the symptoms at baseline on were assessed on a 7-point CGI-I (1=very much improved; 7=very much worse). A decrease in value indicates improvement.|Week 8|Efficacy population=all randomized participants minus 2 patients in the placebo group (1 lost to follow-up, 1 withdrew consent) and 1 participant in the aripiprazole group who discontinued due to AE on Day 2. Data set is LOCF.||units on a scale||Standard Deviation|Mean
724400|NCT00332241|Secondary|Mean Change (Week 8 - Baseline) in the Other ABC Subscale Scores|Mean change (Week 8 - baseline) in the other ABC subscale scores (lethargy/social withdrawal; stereotypic behavior; hyperactivity/ noncompliance; inappropriate speech). A decrease in value indicates improvement|Week 8|Efficacy population=all randomized participants minus 2 patients in the placebo group (1 lost to follow-up, 1 withdrew consent) and 1 participant in the aripiprazole group who discontinued due to AE on Day 2. Data set is LOCF.||units of a scale||Standard Error|Mean
724401|NCT00332241|Secondary|Mean Change (Week 8 – Baseline) in the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS; Compulsion Scale Only)|CY-BOCS=10-item assessment of obsessive-compulsive symptoms in patients <18 years. 5 items pertaining to compulsions rate symptoms (time spent, interference with functioning, distress, resistance, control) on a 5-point scale (0=no symptoms/minimum severity, 4=extreme symptoms/maximum severity). A decrease in value indicates improvement.|Week 8|Efficacy population=all randomized participants minus 2 patients in the placebo group (1 lost to follow-up, 1 withdrew consent) and 1 participant in the aripiprazole group who discontinued due to AE on Day 2. Data set is LOCF.||units on a scale||Standard Error|Mean
724402|NCT00332241|Secondary|Number of Participants With Response at Week 8|Response defined as a ≥ 25% reduction from baseline to endpoint in the ABC Irritability Subscale score and a CGI-I score of 1 or 2 at endpoint|Week 8|Efficacy population=all randomized participants minus 2 patients in the placebo group (1 lost to follow-up, 1 withdrew consent) and 1 participant in the aripiprazole group who discontinued due to AE on Day 2. Data set is LOCF.||participant|||Number
724403|NCT00332241|Secondary|Mean Clinical Global Impressions Improvement Scale (CGI-I) Score|The CGI scale is a clinician-rated global assessment of a patient’s improvement over time. Baseline assessment rated a patient’s condition on a 7-point scale (1=no symptoms, 7=very severe symptoms). Subsequent assessed improvement relative to baseline symptoms on a 7-point CGI-I item scale (1=very much improved, 7=very much worse).|Week 8|Efficacy population=all randomized participants minus 2 patients in the placebo group (1 lost to follow-up, 1 withdrew consent) and 1 participant in the aripiprazole group who discontinued due to AE on Day 2. Data set is LOCF.||units on a scale||Standard Error|Mean
724404|NCT00332241|Primary|Mean Change (Week 8 - Baseline) in the Autistic Behavior Checklist (ABC) Irritability Subscale Score|The ABC is a 58-item informant-based assessment of problem behaviors in children/adolescents with mental retardation. Items are rated on a 4-point scale (0=no problem, 3=severe problem), and resolve into 5 domain subscales. A decrease in score indicates improvement.|Week 8|Efficacy population=all randomized participants minus 2 patients in the placebo group (1 lost to follow-up, 1 withdrew consent) and 1 participant in the aripiprazole group who discontinued due to AE on Day 2. Data set is LOCF.||units on a scale||Standard Error|Mean
725151|NCT00344019|Secondary|Inflammatory Markers (CRP)|No data was analyzed due to small numbers. Collected data no longer available as retention period has passed|24 hours||||||
724405|NCT00332332|Secondary|Percent Change From Baseline to Month 12 in the Dermatology Life Quality Index Total Score|Percent change from Baseline to Month 12 in the Dermatology Life Quality Index (DLQI) total score. This score ranges from 0 to 30, where 0 = no effect and 30 = large effect. A reduction in DLQI total score is indicative of improvement in quality of life as it relates to the participant's psoriasis, and a negative change from Baseline indicates improvement.|Baseline and Month 12|Full Analysis Set, composed of enrolled participants who received at least one dose of study medication and who had a baseline and at least one post-baseline measurement of the endpoint of interest, with imputation using Last Observation Carried Forward (LOCF).||Percent change||95% Confidence Interval|Mean
724406|NCT00332332|Secondary|Percent Change From Baseline to Month 12 in Body Surface Area Affected by Psoriasis|Percent change from Baseline to Month 12 in body surface area (BSA) affected by psoriasis. A reduction (indicated by a negative percent change from Baseline) in the BSA affected is indicative of improvement in disease activity.|Baseline and Month 12|Full Analysis Set, composed of enrolled participants who received at least one dose of study medication and who had a baseline and at least one post-baseline measurement of the endpoint of interest, with imputation using Last Observation Carried Forward (LOCF).||Percent change||95% Confidence Interval|Mean
724407|NCT00332332|Secondary|Percent Change From Baseline to Month 12 in Patient Global Assessment|Percent change from Baseline to Month 12 in the Patient Global Assessment of psoriasis score. This score ranged from 0 (good) to 5 (severe). A negative change from Baseline indicates improvement in disease activity.|Baseline and Month 12|Full Analysis Set, composed of enrolled participants who received at least one dose of study medication and who had a baseline and at least one post-baseline measurement of the endpoint of interest, with imputation using Last Observation Carried Forward (LOCF).||Percent change||95% Confidence Interval|Mean
724408|NCT00332332|Primary|Participants With a Status of Mild or Better on Physician Global Assessment at Month 12|The number of participants with a status of mild or better (score of 0, 1 or 2) on the Physician Global Assessment (PGA) of psoriasis at Month 12. This scale ranges from 0 to 5, with 0 = best outcome.|Month 12|Full Analysis Set, composed of enrolled participants who received at least one dose of study medication and who had a baseline and at least one post-baseline measurement of the endpoint of interest. Missing post-baseline values were imputed using last observation carried forward.||Participants|||Number
724409|NCT00332462|Secondary|Incidence, Safety and Tolerability of Cyclosporine Intravenous (i.v.) During 6 Months Post de Novo Liver Transplantation|The secondary efficacy endpoints included: the incidence of BPAR at 6 months; the incidence of treated acute rejection (TAR) / steroid-resistant acute rejection at 3 and 6 months; the incidence of BPAR with moderate/severe histological grading at 3 and 6 months; time to the first BPAR, the first TAR / steroid-resistant acute rejection and BPAR with moderate/severe histological grading; patient death at 3 and 6 months; and graft loss at 3 and 6 months.|3 or 6 months after transplantation|Intention-to-treat (ITT) population.||Participants|||Number
724410|NCT00332462|Primary|Incidence of Biopsy Proven Acute Rejection During the First 3 Months Post de Novo Liver Transplantation|Number of patients with biopsy proven acute rejection (BPAR) within 3 months after post de novo liver transplantation. In all suspected rejection episodes an allograft biopsy was performed within a 48 hour period of initiation of an anti-rejection therapy. A designated pathologist graded the biopsies according to the Banff criteria into mild, moderate or severe BPAR.|3 months|Intention to treat (ITT) population||Participants|||Number
724411|NCT00332488|Secondary|Change in HbA1c From Baseline to Week 24 (Subjects Who Stayed on Original Treatment)||Week 24|Intent to Treat: Subjects who stayed on original treatment||percentage of total hemoglobin||Standard Deviation|Mean
724412|NCT00332488|Secondary|Difference in Change From Baseline for HbA1c Between TI Alone and Metformin+Secretagogue|(Change from baseline within TI Alone) minus (change from baseline within metformin + secretagogue)|Baseline to Week 12|Intention to Treat (ITT) Population for patients with available data||Percentage of total hemoglobin||Standard Deviation|Mean
724413|NCT00332488|Primary|Difference in Change From Baseline for HbA1c Between TI+ Metformin and Metformin+Secretagogue||Baseline to Week 12|Intention to Treat (ITT) Population with Last Observation Carried Forward||Percentage of total hemoglobin||95% Confidence Interval|Least Squares Mean
724414|NCT00332579|Primary|Yale Brown Obsessive Compulsive Scale Modified for Kleptomania (K-YBOCS)|The K-YBOCS measures symptom severity (urges/thoughts and behavior) across the past week. Scores range from 0 (no symptoms) to 40 (highest symptom severity).|K-YBOCS is done at each visit by the investigator.|Reported scores are Mean and standard deviation for Subjects last visit (Week 8 or last-observation carried forward).||units on a scale||Standard Deviation|Mean
724415|NCT00332605|Primary|Penn Craving Scale|used to measure cravings to use drugs over the past week. Range of TOTAL scores is 0-30. A lower score indicates a better outcome, while a higher score indicates a worse outcome.|beginning and at each visit until the end of their participation in the study|Reported scores are Mean and standard deviation for Subjects last visit (including last-observation carried forward).||units on a scale||Standard Deviation|Mean
724416|NCT00332644|Primary|7-day Point Prevalence of Smoking, Biochemically (Exhaled CO) Confirmed|Smoking status was assessed both as 7-day point-prevalence abstinence (“Have you smoked at all, even a puff, in the last 7 days?”) and continuous abstinence (smoking at all since the target quit day), using a smoking calendar and the timeline follow-back method. All participants’ self-reports of smoking status during study visits were confirmed by an expired carbon monoxide level of less than 10 ppm measured using a Micro-3 Smokerlyzer (Bedfont Scientific, Williamsburg, Virginia).|6 months post quit date|||participants with<10 ppm exhaled CO|||Number
724417|NCT00332696|Secondary|Participant's Quality of Life Using the Edmonton Scale|The Edmonton Scale consisted of 9 items: pain, activity, nausea, depression, anxiety, fatigue, appetite, sensation of well-being and dyspnea (difficult or labored breathing). Participants rated these items on a scale of 0 to 10, with 10 being the worse.|Day 1, Day 7, Day 14, Month 1, Month 2 and Month 3|"Intent-to-treat population consisted of all participants who received at least one dose of study drug. n in each of the categories is the number of participants who had Quality of Life data at that time point."||Scores on a scale||Standard Deviation|Mean
724418|NCT00332696|Secondary|Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 3|Recurrence of bowel obstruction was confirmed by abdominal X-ray.|Month 3|Participants from the Intent-to-treat population (consisting of all randomized participants who received at least one dose of study drug) for whom data was available at Month 3.||Participants|||Number
724423|NCT00332696|Secondary|Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 7|Participants rated their nausea intensity on a scale of 0 to 3, with 3 being the worse. The number of participants with a score of 0, a score of 1, a score of 2 and a score of 3 are presented for Day 7.|Day 7|Participants from the Intent-to-treat population consisting of all randomized participants who received study drug and for whom data was available at Day 7.||Participants|||Number
724424|NCT00332696|Secondary|Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 1|Participants rated their nausea intensity on a scale of 0 to 3, with 3 being the worse. The number of participants with a score of 0, a score of 1, a score of 2 and a score of 3 are presented for Day 1.|Day 1|Intent-to-treat population consisted of all randomized participants who received at least one dose of study drug.||Participants|||Number
724425|NCT00332696|Secondary|Number of Vomiting Episodes Per Day at Day1, Day 2 and Day 14|The mean number of vomiting episodes per a 24 hour period is presented for Day 1, Day 7 and Day 14.|Day 1, Day 7 and Day 14|"Intent-to-treat population consisted of all randomized participants who received study drug. n in each of the categories is the number of participants with data at the given time point."||Vomiting episodes||Standard Deviation|Mean
724426|NCT00332696|Secondary|Number of Participants With Treatment Success From Day 5 to Day 7|Day 7 treatment success was defined as improvement of symptoms in the previous 2 days (average number of vomiting episodes less than 2 from Day 5, no Nasogastric Tube (NGT) since Day 5 and no anticholinergic agent or withdrawal from trial).|Day 5 to Day 7|Intent-to-treat population consisted of all randomized participants who received at least one dose of study drug.||Participants|||Number
724427|NCT00332696|Primary|Number of Participants With Treatment Success From Day 10 to Day 13|"Treatment Success was defined as: less than 2 episodes of vomiting on average per day for the 4 days prior to Day 14 [from Day 10 to Day 13] and no use of an Nasogastric Tube (NGT) since at least Day 10 and no use of an anticholinergic agent until Day 14.
Treatment Failure is defined as: 2 or more episodes of vomiting per day on average for the 4 days prior to Day 14 or use of an NGT after Day 9 or use of an anticholinergic agent before Day 14 or withdrawal from the trial between Day 1 and Day 14 (included), whatever the cause."|Day 10 to Day 13|Intent-to-treat population consisted of all randomized participants who received at least one dose of study drug.||Participants|||Number
724428|NCT00332709|Secondary|Change in Z-Score From Baseline to Month 12|(DXA). The Z-Score is the number of standard deviations a patient's BMD differs from the average BMD of their age, sex and ethnicity. A Z-score of less than minus -1.5 raises concern of factors other than aging as contributing to osteoporosis|Baseline, Month 12|(ITT) The study population will consist of post menopausal breast cancer patients who have completed 4 to 6 years of adjuvant Tamoxifen therapy after therapy. Participants with observations at both baseline and endpoint were included in this analysis||Z-Score||Standard Deviation|Mean
724429|NCT00332709|Secondary|Change in T-Score From Baseline to Month 12|BMD measured by DXA (dual energy x-ray absorptiometry) at lumbar spine, L1-L4. The T-Score is a comparison of a patient's BMD to that of a healthy 30 year of the same sex and ethnicity. The criteria of the World Health Organization are Normal is a T-Score of 1.0 or higher. Osteopenia is defined as between - 1.0 and -2.5. Osteoporosis is defined as -2.5 or lower, meaning a bone density that is two and half standard deviations below the mean of a 30 year old man/woman.|Baseline, Month 12|(ITT) The study population will consist of post menopausal breast cancer patients who have completed 4 to 6 years of adjuvant Tamoxifen therapy after therapy. Participants with observations at both baseline and endpoint were included in this analysis.||T-Score||Standard Deviation|Mean
724430|NCT00332709|Primary|Change in Z Score From Baseline to Month 36|Bone Mineral Density is measured by dual energy x-ray absorptiometry (DXA). The Z-Score is the number of standard deviations a patient's BMD differs from the average BMD of their age, sex and ethnicity. A Z-score of less than minus -1.5 raises concern of factors other than aging as contributing to osteoporosis.|Baseline, month 36|(ITT) The study population will consist of post menopausal breast cancer patients who have completed 4 to 6 years of adjuvant Tamoxifen therapy after therapy. Participants with observations at both baseline and endpoint were included in the analysis.||Z-Score||Standard Deviation|Mean
724431|NCT00332709|Primary|Change in T-score From Baseline to Month 36|BMD measured by DXA (dual energy x-ray absorptiometry) at lumbar spine, L1-L4. The T-Score is a comparison of a patient's BMD to that of a healthy 30 year of the same sex and ethnicity. The criteria of the World Health Organization are Normal is a T-Score of 1.0 or higher. Osteopenia is defined as between - 1.0 and -2.5. Osteoporosis is defined as -2.5 or lower, meaning a bone density that is two and half standard deviations below the mean of a 30 year old man/woman.|Baseline and Month 36|(ITT) The study population will consist of post menopausal breast cancer patients who have completed 4 to 6 years of adjuvant Tamoxifen therapy after therapy.Participants with observations at both baseline and endpoint were included in the analysis.||T-Score||Standard Deviation|Mean
724432|NCT00332709|Primary|Percent Change in Bone Mineral Density (BMD) From Baseline to Month 36|"Bone Mineral Density is measured by dual energy x-ray absorptiometry (DXA) scan.
ANCOVA model was used in the analysis where: Variable = Baseline, Center, Treatment BMD = (Month 36 BMD-Baseline BMD)/Baseline BMD*100."|Baseline, Month 36|(ITT) The study population will consist of post menopausal breast cancer patients who have completed 4 to 6 years of adjuvant Tamoxifen therapy after therapy. Participants with observations at both baseline and endpoint were included in the analysis.||Percent Change in BMD||Standard Deviation|Mean
724433|NCT00332709|Secondary|Median Disease Free Survival (DFS)|Disease Free Survival is measured in days and represents the number of days participants were progression free. Progression free survival is defined as the time from randomization to the date of the first documented progression or recurrence of disease or death from any cause. Median disease free survival is the time when 50% of the patients had a recurrence.|36 months|(ITT) The study population will consist of post menopausal breast cancer patients who have completed 4 to 6 years of adjuvant Tamoxifen therapy after therapy. The median disease free survival was not observed because patients in the combination therapy did not have any recurrences.||Months||95% Confidence Interval|Median
724434|NCT00332709|Secondary|Number of Participants With Any Kind of Fractures, by Visit.|Number of participants with fractures of any type since the last visit|Baseline, Month 6, 12, 18, 24 , 30 and 36|(ITT) The study population will consist of post menopausal breast cancer patients who have completed 4 to 6 years of adjuvant Tamoxifen therapy after therapy. Participants with observations from baseline to month 36 were included in this analysis.||Participants|||Number
724435|NCT00332709|Secondary|Change in Bone Mineral Density From Baseline to 12 Months|Change in bone mineral density (BMD) measured by dual X-ray absorptiometry (DXA) in lumbar spine (L1-L4). Change calculated by (Month 36 BMD-Baseline BMD)/Baseline BMD*100.|Baseline, 12 months|(ITT) The study population will consist of post menopausal breast cancer patients who have completed 4 to 6 years of adjuvant Tamoxifen therapy after therapy. Participants with observations at both baseline and endpoint were included in the analysis.||g/cm^2||Standard Deviation|Mean
724436|NCT00332709|Primary|Change in Bone Mineral Density (BMD) From Baseline to Month 36|Change in bone mineral density (BMD) measured by dual X-ray absorptiometry (DXA) in lumbar spine (L1-L4). Change calculated by (Month 36 BMD-Baseline BMD)/Baseline BMD*100.|at 36 months as compared to baseline|(ITT) The study population will consist of post menopausal breast cancer patients who have completed 4 to 6 years of adjuvant Tamoxifen therapy after therapy. Participants with observations at both baseline and endpoint were included in the analysis.||Percent||Standard Deviation|Mean
724437|NCT00332722|Secondary|Neck Disability Index (NDI)|Neck Disability Index (range 0-50) is represented as 0-4 no disability, 5-14 mild disability, 15 - 24 moderate disability, 25 - 34 severe disability and >34 (35-50) complete disability.|2 years|||units on a scale||Standard Deviation|Mean
724438|NCT00332722|Primary|Numeric Rating Scale (NRS)|Numeric Rating Scale (range 0-10) is represented as 0 for no pain and 10 for worst pain imaginable.|over 2 years|A sample size of 60 patients for each group was chosen.||units on a scale||Standard Deviation|Mean
724439|NCT00338286|Secondary|Percentage of Participants With Suspected Thrombotic Vascular Events (TVEs)|Suspected TVEs were identified by investigators and relevant clinical information was collected.|up to 8.4 years|The intent to treat (ITT) population included all participants who were randomized in either Standard of Care (SOC) or Epoetin alfa group.||Percentage of participants|||Number
724440|NCT00338286|Secondary|Overall Response Rate (ORR)|Overall response was RECIST criteria. Complete response (CR) is appearance of all target and non-target lesions. Partial response (PR):a) 30% decrease in sum of lactate dehydrogenase(LD) of target lesions from baseline OR b) complete disappearance of target lesions, with persistence of one or more non-target measurable lesion or one or more non-measurable, evaluable lesions. Progressive disease(PD):a) 20% increase in sum of LDs of target lesions, taking as reference smallest sum LD recorded since treatment started; OR b) appearance of one or more new lesions or a clear worsening of measurable non-target lesions or evaluable disease with stable measurable lesions. Stable disease (SD):a) sufficient shrinkage to qualify for PR;b) sufficient increase to qualify for PD. Non evaluable(NE) lesion: all other lesions, including small lesions (longest diameter <20 millimeter (mm) with conventional techniques or <10 mm with spiral CT scan) and truly non-measurable lesions.|every 8 weeks for 1 year and then every 12 weeks until PD or death, whichever occurred first (up to 8.4 years)|The intent to treat (ITT) population included all participants who were randomized in either Standard of Care (SOC) or Epoetin alfa group.||Percentage of participants|||Number
724441|NCT00338286|Secondary|Time to Tumor Progression|The Time to tumor progression (TTP) was defined as the time from the date of starting treatment until the date of first documented evidence of progression of tumor. TTP was measured from the date of randomization to the date of the first documented PD (including death due to PD without prior PD).|From date of randomization to the date of the first documented PD (up to 8.4 years)|The intent to treat (ITT) population included all participants who were randomized in either Standard of Care (SOC) or Epoetin alfa group.||Months||95% Confidence Interval|Median
724442|NCT00338286|Secondary|Overall Survival|Overall survival (OS) was defined as the interval between the date of randomization to the date of death from any cause. For participants who were lost to follow-up or withdrew before the clinical cutoff, OS was censored at the last date the participants was known to be alive. For participants who were still alive and on study at the time of the clinical cutoff, OS was censored at the date of clinical cutoff.|From randomization up to death from any cause (up to 8.4 years)|The intent to treat (ITT) population included all participants who were randomized in either Standard of Care (SOC) or Epoetin alfa group.||Months||95% Confidence Interval|Median
724443|NCT00338286|Primary|Progression Free Survival|Progression free survival was based in investigator-determined progressive disease (PD) and calculated from the date of randomization to the date of PD or the date of death, whichever occurred first. Participants who had not progressed and were still alive at the time of clinical cutoff were censored at the last disease assessment prior to the clinical cutoff. For PD or death with a missing interval immediately preceding the event, progression-free survival (PFS) was censored at the last disease assessment prior to the missing interval. Participants who withdrew from the study (withdrawal of consent or lost to follow-up) without progression were censored at the time of the last disease assessment.|From the date of randomization to the date of disease progression (PD) or death, whichever occurred first (up to 8.4 years)|The intent to treat (ITT) population included all participants who were randomized in either Standard of Care (SOC) or Epoetin alfa group.||Months||95% Confidence Interval|Median
724444|NCT00338455|Secondary|Changes in Pulmonary Artery Pressure (PAP): Systolic, Diastolic, and Mean||28 days|Early termination of the study due to enrollment difficulties; efficacy not analyzed.|||||
724445|NCT00338455|Secondary|All Cause Mortality||Day 30 and Months 2 and 6|Early termination of the study due to enrollment difficulties; efficacy not analyzed.|||||
724446|NCT00338455|Secondary|Changes in Pulmonary Capillary Wedge Pressure (PCWP)||28 days|Early termination of the study due to enrollment difficulties; efficacy not analyzed.|||||
724447|NCT00338455|Primary|Number of Days Alive Without Renal, Hemodynamic, or Electrical Clinical Worsening Through Day 28 (Termination of Treatment)|Number of calendar days alive without renal, hemodynamic, or electrical clinical worsening through Day 28 (termination of treatment or early discontinuation of treatment, whichever occurred first). The endpoint was not normalized for time on study.|28 days|Early termination of the study due to enrollment difficulties; efficacy not analyzed.|||||
724448|NCT00338598|Secondary|Baseline and End of Treatment Neurophysiological Measures||12 weeks|Data was not collected|||||
724449|NCT00338598|Secondary|Baseline and End of Treatment Quality of Life||12 weeks|Data was not collected|||||
724450|NCT00338598|Secondary|Weekly Drug Use||12 weeks|Data was not collected|||||
724451|NCT00338598|Primary|Baseline and End of Treatment Cognitive Functioning Measures (Hopkins)|Hopkins Verbal Learning Test Assesses short term verbal learning and memory. Subscales include immediate recall (0-36), delayed recall (0-12) , and recognition (0-12). A higher score indicates better memory performance.|12 weeks|||units on a scale||Standard Error|Mean
724452|NCT00338598|Primary|Weekly Ratings of Negative/Positive Psychotic Symptoms|The PANSS or the Positive and Negative Syndrome Scale is a medical scale used for measuring symptom severity of patients with schizophrenia. The patient is rated from 1 to 7 on 30 different symptoms based on the interview as well as reports of family members or primary care hospital workers. Of the 30 items included in the PANSS, 7 constitute a Positive Scale, 7 a Negative Scale, and the remaining 16 a General Psychopathology Scale.The scores for these scales are arrived at by summation of ratings across component items. Therefore, the potential ranges are 7 to 49 for the Positive and Negative Scales, and 16 to 112 for the General Psychopathology Scale. A higher score indicates more severe symptoms for each scale.|12 weeks|||units on a scale||Standard Error|Mean
724453|NCT00338598|Primary|Self Reported Weekly Alcohol Craving|The Obsessive Compulsive Drinking Scale (OCDS) is consisted by 14 items rated 0 - 4. The minimum and maximum values possibly obtained in this scale are respectively 0 and 56, this last one, meaning the most craving possible experienced. It is a short and easy to administer scale (average of 5 minutes per self-rating), built to measure severity and improvement during alcoholism treatment trials.|12 weeks|||units on a scale||Standard Error|Mean
724454|NCT00338598|Primary|Self Reported Weekly Alcohol Consumption|Percentage of drinking days and heavy drinking days using timeline follow back|12 weeks|||percentage of days||Standard Error|Mean
724455|NCT00342355|Primary|Progression to AIDS or Death in tx naïve Pts With Adv HIV dx in the Four Randomly Assigned Regimens.|Progression of disease, AIDS, or death in treatment naive patients with advanced HIV diagnosis will be evaluated in the four randomly assigned regimens.|January 2004 until March 31 2008|||participants|||Number
724456|NCT00342355|Secondary|Serious Adverse Events|Safety outcomes in four different randomly assigned regimens|January 2004 until March 31, 2008|||participant|||Number
724457|NCT00342563|Primary|Self-report Average Number of Cigarettes Per Day|self-report from only the smoking population for cigarettes per day|12 weeks|only smokers||cigarettes||Standard Error|Mean
724458|NCT00342563|Primary|Self-report Weekly Smoking Craving|Questionnaire of smoking urges (QSU). It has 32 questions that range from 1 to 7, there are 8 questions per sub-scale. The total range is 32 to 224. Each sub-scale ranges from 8- 56, with a higher score indicating higher craving.|12 weeks|Smokers only||units on a scale||Standard Error|Mean
724459|NCT00342563|Primary|Self-report Weekly Craving Via Obsessive Compulsive Drinking Scale (OCDS)|The OCDS is a 14-item (rated 0-4), self-administered questionnaire for characterizing and quantifying the obsessive and compulsive cognitive aspects of craving and heavy (alcoholic) drinking, such as drinking-related thought, urges to drink, and the ability to resist those thoughts and urges. A higher total score indicates higher craving and ranges from 0-48.|12 weeks|Scores presented are total, and then by subgroup.||units on a scale||Standard Error|Mean
724460|NCT00342563|Primary|Percent Heavy Drinking Days During Active Treatment Phase|Data were calculated as number of heavy drinking days (heavy drinking days is defined as 5 drinks on a single occasion for men and 4 for women) average during 90 days of treatment.|12 weeks|||days||Standard Error|Mean
724461|NCT00342628|Secondary|Antibody Responses to Hib CP|IgG anti-Hib CP was measured by ELISA in sera of 30 randomly chosen infants per group|Cord sera and infant sera at 7, 12, and 13 months|Randomly chosen 30 participants in each group. Four in Comparison group 2 were excluded from analyses due to classification error.||mcg/ml||Inter-Quartile Range|Geometric Mean
724462|NCT00342628|Secondary|Antibody Responses to Tetanus Toxoid, Diphtheria Toxoid, and Pertussis Toxin|IgG anti-diphtheria toxoid (DT), -tetanus toxoid (TT) and -pertussis toxin (PT) were measured by ELISA in sera of 30 randomly chosen infants per group.|Cord sera, and infants' sera at 7, 12 and 13 months of age|Randomly chosen 30 participants in each group. Four in Comparison group 2 were excluded from analyses due to classification error.||U/ml||Inter-Quartile Range|Geometric Mean
724463|NCT00342628|Secondary|IgG Anti-Vi Levels|IgG anti-Vi was measured by ELISA and expressed as ELISA units (EU)in all sera.|cord sera, infants' sera at 7, 12 and 13 months|Only participants with available cord sera are included in the analyses||ELISA units||Inter-Quartile Range|Geometric Mean
724464|NCT00342628|Primary|Number of Infants With Adverse Reactions After Vaccination|Number of infants with Fever>=38.0 C, Induration>=2.5cm at DTP site, Induration>=2.5cm,Vi-rEPA/Hib-TT site, Erythema>=2.5cm, at DTP site, Erythema>=2.5cm, Vi-rEPA/Hib-TT site, Inconsolable crying<4hr, Inconsolable crying>=4hr per injection with Vi conjugate vaccine given in conjunction with DTP in infants.|at 2, 4, 6 and 12 months|The number of infants injected in each group for each injection was used to determine the rate of adverse reactions.||participants|||Number
724465|NCT00343044|Secondary|Number or Participants With Toxicity||measured at each treatment cycle|||participants|||Number
724466|NCT00343044|Secondary|Objective Response Rate|RECIST criteria|Response|||participants|||Number
724467|NCT00343044|Secondary|Evaluation of Overall Survival|Overall survival was defined as the number of months after commencing study treatment to death.|PFS and OS were defined as the number of months after commencing study treatment until progressive disease or death.|The planned enrollment of 40 participants was determined using a median PFS of 9 months (based on a median PFS of 7.2 months in a previous trial).||months||95% Confidence Interval|Median
724468|NCT00343044|Primary|Progression Free Survival|Progression free survival(PFS)was measured by Response Evaluation Criteria in Solid Tumors (RECIST) criteria in patients with measurable disease. For patients with nonmeasurable disease, cancer antigen (CA-125) levels were used to determine response according to Rustin criteria. Progression-free survival was defined as number of months after beginning study treatment until progressive disease or death, respectively.|PFS and OS were defined as the number of months after commencing study treatment until progressive disease or death.|This was determined assuming a median progression free survival of 9 months and an analysis calculating the sample size at which the narrowing of its 95% confidence interval became greater than .20 for every 2 patients added. Progression free survival and overall survival were estimated by using the Kaplan Meier method.||months||95% Confidence Interval|Median
724469|NCT00343083|Secondary|Clinical Complete Response Rate of This Regimen in the Population|What is the the complete response (CR) rate at the completion of therapy.|3 months|||percentage of participants|||Number
724499|NCT00343291|Secondary|Overall Survival|Overall survival is defined as the time from randomization to death. Participants who are alive will be censored on the last known alive date.|Randomization to the date of death from any cause up to 42.7 months|Included all enrolled, randomized participants. All participants were analyzed as part of the treatment group to which they were randomized.||months||95% Confidence Interval|Median
724470|NCT00343083|Secondary|Percentage of Participants With Grade 3 Toxicities of Cetuximab|"One of the more serious side effects of cetuximab therapy is the incidence of acne-like rash. This rash rarely leads to dose reductions or termination of therapy. It is generally reversible.
Further severe infusion reactions include but are not limited to: fevers, chills, rigors, urticaria, pruritis, rash, hypotension, N/V, HA, bronchospasm, dyspnea, wheezing, angioedema, dizziness, anaphylaxis, and cardiac arrest. Therefore, pretreatment with diphenhydramine 30-60 min. before administration is standard of care. Other common side effects include photosensitivity, hypomagnesemia due to magnesium wasting, and less commonly pulmonary and cardiac toxicity."|9 weeks|||percentage of participants|||Number
724471|NCT00343083|Secondary|Pathological Response to Cetuximab|Adding CTX to weekly PC and daily RT. CBC and Chemistry panel blood testing|2 years|||participants|||Number
724472|NCT00343083|Secondary|Overall Survival and Disease-free Survival||3 years (overall) 2 years disease-free|||percentage of participants|||Number
724473|NCT00343083|Secondary|Local Regional Control at 2 Years||2 years|||percentage of participants|||Number
724474|NCT00343083|Primary|The Primary Endpoint is the Local Regional Control Rate Assessed 3 Months Post Completion of Radiation Therapy.|The local regional control rate was assessed 3 months post completion of radiation therapy based on either MRI or CT and clinical exam.|3 months|||participants|||Number
724475|NCT00343252|Secondary|Change From Baseline to 18-Month Endpoint in European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO)|QUALEFFO is an osteoporosis-specific health instrument developed specifically for participants with vertebral deformities used to evaluate the effect of back pain and treatment on quality of life. The QUALEFFO questionnaire includes 41 items in 5 domains: pain, physical function, social function, general health perception, and mental function. The total score is calculated according to the scoring algorithm developed by the International Osteoporosis Foundation. Total scores are reported from 0 to 100, with lower scores corresponding to better quality of life.|Baseline, 18 Months|Intent-to-treat (ITT). Participants who were randomized and received at least one dose of the study drug.||units on a scale||Standard Error|Least Squares Mean
724476|NCT00343252|Secondary|Change From Baseline to 18-Month Endpoint in the Roland-Morris Disability Questionnaire.|Roland-Morris Disability Questionnaire (RMDQ-24) is completed by the participant and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability). Pooled site, baseline glucocorticoid usage status (yes/no) and baseline score were controlled for.|Baseline, 18 Months|Intent-to-treat (ITT). Participants who were randomized and received at least one dose of the study drug.||units on a scale||Standard Error|Least Squares Mean
724477|NCT00343252|Secondary|Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 18 Months|Time to first occurrence of >=30% pain reduction in average back pain from baseline to 18 months. Average back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the average back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of average back pain up to time (t) in days.|Baseline through 18 Months|Randomized intent-to-treat (ITT) participants in each treatment group with non-missing time.||participants|||Number
724478|NCT00343252|Secondary|Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 18 Months|Time to first occurrence of >= 30% pain reduction in worst back pain from baseline to 18 months. Worst back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the worst back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of worst back pain up to time (t) in days.|Baseline through 18 Months|Analysis includes number of randomized intent-to-treat (ITT) participants in each treatment group with non-missing time.||participants|||Number
724479|NCT00343252|Secondary|Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 18-Month Endpoint|24-hour average back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of average back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of average back pain from baseline to the 18-month last observation carried forward (LOCF) endpoint.|18 Months|Intent-to-treat (ITT). ITT participants were participants who randomized and received at least one dose of the study drug.||participants|||Number
724480|NCT00343252|Secondary|Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 18-Month Endpoint|24-hour worst back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of worst back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of worst back pain from baseline to the 18-month last observation carried forward (LOCF) endpoint.|18 Months|Intent-to-treat (ITT). Participants are participants who were randomized and received at least one dose of the study drug.||participants|||Number
724481|NCT00343252|Secondary|Number of Participants With Adverse Events (Safety) During 18 Months|Safety is assessed via serious adverse events and all other non-serious adverse events and the data are located in the Reported Adverse Events Section.|Baseline through 18 Months|Intent-to-treat (ITT). ITT participants are randomized participants who received at least one dose of teriparatide or risedronate.||participants|||Number
724482|NCT00343252|Secondary|Number of Participants With Adverse Events (Safety) During 12 Months|Safety was assessed via serious adverse events and all other non-serious adverse events and the data are located in the Reported Adverse Events Section.|Baseline through 12 Months|Intent-to-treat (ITT). ITT participants are randomized participants who received at least one dose of teriparatide or risedronate.||participants|||Number
725152|NCT00344019|Secondary|Other Biomarkers of Myocyte Injury (CK, CK-MB)|No data was analyzed due to small numbers. Collected data no longer available as retention period has passed|24 hours||||||
724483|NCT00343252|Secondary|Change From Baseline to 12-Month Endpoint, European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO)|QUALEFFO is an osteoporosis-specific health instrument developed specifically for participants with vertebral deformities used to evaluate the effect of back pain and treatment on quality of life. The QUALEFFO questionnaire includes 41 items in 5 domains: pain, physical function, social function, general health perception, and mental function. The total score is calculated according to the scoring algorithm developed by the International Osteoporosis Foundation. Total scores are reported from 0 to 100, with lower scores corresponding to better quality of life.|Baseline, 12 Months|Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.||units on a scale||Standard Error|Least Squares Mean
724484|NCT00343252|Secondary|Change From Baseline to 6-Month Endpoint, European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO)|QUALEFFO is an osteoporosis-specific health instrument developed specifically for participants with vertebral deformities used to evaluate the effect of back pain and treatment on quality of life. The QUALEFFO questionnaire includes 41 items in 5 domains: pain, physical function, social function, general health perception, and mental function. The total score is calculated according to the scoring algorithm developed by the International Osteoporosis Foundation. Total scores are reported from 0 to 100, with lower scores corresponding to better quality of life.|Baseline, 6 Months|Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.||units on a scale||Standard Error|Least Squares Mean
724485|NCT00343252|Secondary|Change From Baseline to 12-Month Endpoint in the Roland-Morris Disability Questionnaire.|Roland-Morris Disability Questionnaire (RMDQ-24) is completed by the participant and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability).|Baseline, 12 Months|Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.||units on a scale||Standard Error|Least Squares Mean
724486|NCT00343252|Secondary|Change From Baseline to 6-Month Endpoint in the Roland-Morris Disability Questionnaire.|Roland-Morris Disability Questionnaire (RMDQ-24) is completed by the participant and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability).|Baseline, 6 Months|Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.||units on a scale||Standard Error|Least Squares Mean
724487|NCT00343252|Secondary|Change From Baseline to 3-Month Endpoint in the Roland-Morris Disability Questionnaire.|Roland-Morris Disability Questionnaire (RMDQ-24) is completed by the participant and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability).|Baseline, 3 Months|Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.||units on a scale||Standard Error|Least Squares Mean
724488|NCT00343252|Secondary|Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 12 Months|Time to first occurrence of >= 30% pain reduction in average back pain from baseline to 12 months. Average back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the average back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of average back pain up to time (t) in days.|Days 0, 60, 120, 180, 240, 300, 360, 420, 480, 540, and 600|Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Participants with non-missing outcomes were analyzed.||participants|||Number
724489|NCT00343252|Secondary|Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 6 Months|Time to first occurrence of >=30% pain reduction in average back pain from baseline to 6 months. Average back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the average back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of average back pain up to time (t) in days.|Days 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, and 300|Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Participants with non-missing outcomes were analyzed. The results are reported as the number of participants reporting at least a 30% reduction in the severity of back pain after time (t) in days.||participants|||Number
724490|NCT00343252|Secondary|Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 12 Months|Time to first occurrence of >= 30% pain reduction in worst back pain from baseline to 12 months. Worst back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the worst back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of worst back pain up to time (t) in days.|Days 0, 60, 120, 180, 240, 300, 360, 420, 480, 540, and 600|Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Participants with non-missing outcomes were analyzed.||participants|||Number
725268|NCT00351819|Primary|Weighted Pinprick Stimulator-induced Mechanical Pain at Week 14|Weighted pinprick stimulators are used to assess mechanical pain. Lower values represent better tolerance of pain.|Week 14 after intervention|||watts||Standard Deviation|Mean
724491|NCT00343252|Secondary|Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 6 Months|Time to first occurrence of >= 30% pain reduction in worst back pain from baseline to 6 months. Worst back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the worst back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of worst back pain up to time (t) in days.|Days 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, and 300|Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Participants with non-missing outcomes were analyzed.||participants|||Number
724492|NCT00343252|Secondary|Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 12-Month Endpoint|24-hour average back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of average back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of average back pain from baseline to the 12-month last observation carried forward (LOCF) endpoint.|12 Months|Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.||participants|||Number
724493|NCT00343252|Secondary|Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 6-Month Endpoint|24-hour average back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of average back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of average back pain from baseline to the 6-month last observation carried forward (LOCF) endpoint.|6 Months|Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.||participants|||Number
724494|NCT00343252|Secondary|Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 12-Month Endpoint|24-hour worst back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of worst back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of worst back pain from baseline to the 12-month last observation carried forward (LOCF) endpoint.|12 Months|Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.||participants|||Number
724495|NCT00343252|Primary|Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 6-Month Endpoint|24-hour worst back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of worst back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of worst back pain from baseline to the 6-month last observation carried forward (LOCF) endpoint.|6 Months|Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.||participants|||Number
724496|NCT00343291|Secondary|Percentage of Participants With Symptomatic Response (Symptom Response Rate)|Functional Assessment of Cancer Therapy for Patients With Lung Cancer (FACT-L) measures domains of health-related quality of life (HR-QL): physical wellbeing (WB), social/family WB, emotional WB, functional WB, and additional lung cancer concerns. Symptom response (improvement) was defined as ≥2 point increase from baseline in the 7-item Lung cancer subscale (LCS) score maintained for 2 consecutive assessments. Scores range from 0-28 with higher scores indicating fewer symptoms. Patients with a score of >26 were not evaluable for symptom response, since a score of 28 is the maximum possible.|From date of partial response until progression of disease up to 31.8 months|Included all enrolled, randomized participants with a score of ≤26 at baseline. All participants were analyzed as part of the treatment group to which they were randomized.||percentage of participants||95% Confidence Interval|Number
724497|NCT00343291|Secondary|Duration of Overall Response|The duration of response, in participants with best overall response of CR or PR, is measured from the date criteria are met for CR/PR (whichever is first recorded), until the first date that the criteria for PD is met or death. CR, PR, and PD, as classified by the investigator according to the RECIST guidelines. CR=disappearance of all target lesions; PR≥30% decrease in sum of longest diameter of target lesions; PD≥20% increase in sum of longest diameter of target lesions. Participants who are alive and without PD will be censored at the date of their last tumor assessment.|Time of first response to the first date of PD or death due to any cause up to 31.8 months|Included all enrolled, randomized participants with a best overall response of CR or PR (responders). All participants were analyzed as part of the treatment group to which they were randomized.||months||95% Confidence Interval|Median
724498|NCT00343291|Secondary|Percentage of Participants Achieving an Objective Overall Response (Overall Response Rate)|The best objective overall response rate (ORR) is the percentage of randomized participants with a best overall response of complete response (CR) or partial response (PR), as classified by the investigator according to the RECIST guidelines. CR=disappearance of all target lesions; PR≥30% decrease in sum of longest diameter of target lesions. ORR is calculated as a total number of participants with CR or PR divided by the total number of participants treated in that arm, multiplied by 100. Participants with no post-baseline evaluation will be considered as a non-responder.|Randomization to measured progressive disease up to 31.8 months|Included all enrolled, randomized participants. All participants were analyzed as part of the treatment group to which they were randomized.||percentage of participants||95% Confidence Interval|Number
724500|NCT00343291|Primary|Progression Free Survival (PFS)|PFS is defined as the time from randomization until the date of progression of disease (PD) or death from any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD ≥20% increase in sum of longest diameter of target lesions. Participants who are alive and without PD will be censored at the date of their last tumor assessment.|Randomization to PD or date of death from any cause up to 33.1 months|Included all enrolled, randomized participants. All participants were analyzed as part of the treatment group to which they were randomized.||months||95% Confidence Interval|Median
724501|NCT00343382|Secondary|Change From Baseline to Week 6 on the Impact of Vaginal Dryness for Activities of Daily Living Scores|The impact of vaginal dryness for activities of daily living (ADL) were measured by the numerical analogue scales at baseline and through the six weeks of treatment. The item scores was transformed into 0 to 100 scales with 0=poor quality of life (QOL) and 100=best possible QOL. The change from baseline scores was calculated by subtracting the baseline item scores from the scores at 6 week.|Baseline and Week 6|Includes all participants who completed both baseline and week 6 assessments.||units on a scale||Standard Deviation|Mean
724502|NCT00343382|Secondary|Average AUC Summary Statistics for the Impact of Vaginal Dryness for Activities of Daily Living|The impact of vaginal dryness for activities of daily living (ADL) were measured by the numerical analogue scales at baseline and through the six weeks of treatment. The item scores was transformed into 0 to 100 scales with 0=poor quality of life (QOL) and 100=best possible QOL. The average AUC values were calculated by dividing 6 from AUC values for participants who completed item on all 6 weeks. If a participant completed the item at baseline, week 1, 2 and 3 but did not complete the item at week 4 to week 6, the AUC values of the item was prorated, which is (((AUC values * 6) / 3) / 6). The average pro-rated AUC scores was compared in each of the Pilocarpine arms against the collective placebo arm.|Baseline to Week 6|Includes all participants that reported a baseline value and at least one value after baseline (i.e. week 3, 4, 5 or 6).||units on a scale||Standard Deviation|Mean
724503|NCT00343382|Secondary|Toxicity as Measured by Common Terminology Criteria for Adverse Events (CTCAE) 3.0|CTCAE Grading: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death.|End of 6 weeks|||participants|||Number
724504|NCT00343382|Primary|Average Vaginal Dryness Scores Via Area Under the Curve (AUC) Summary Statistics|Vaginal dryness was measured by the numerical analogue scale at baseline and through the six weeks of treatment. The item scores was transformed into 0 to 100 scales with 0=poor quality of life (QOL) and 100=best possible QOL. The average AUC values were calculated by dividing 6 from AUC values for participants who completed item on all 6 weeks. If a participant completed the item at baseline, week 1, 2 and 3 but did not complete the item at week 4 to week 6, the AUC values of the item was prorated, which is (((AUC values * 6) / 3) / 6). The average pro-rated AUC for vaginal dryness scores was compared in each of the Pilocarpine arms against the collective placebo arm.|Baseline to Week 6|Includes all participants that reported a baseline value and at least one value after baseline (i.e. week 3, 4, 5 or 6).||units on a scale||Standard Deviation|Mean
724505|NCT00343460|Secondary|Patient's Global Satisfaction With Antiemetic Therapy During Acute Phase and Chemotherapy Course 1|Subject who were very satisfied on Day 1|0- 24 Hours|Cycle 1 - Modified Intent-to-Treat Population||participants|||Number
724506|NCT00343460|Secondary|Quality of Life and the Impact of Nausea and Vomiting on Day 5|Functional Living Index|5 days|Cycle 1 - Modified Intent-to-Treat Population (All Languages Except Punjabi)||participants|||Number
724507|NCT00343460|Secondary|Sustainability of Antiemetic Effect of APF530 Over Multiple Chemotherapy Courses|"Sustainability of Overall Complete Response (CR 0-120 hrs) Over Two, Three, and Four Cycles
Complete Response is defined as no emetic episodes and no use of rescue medications"|0-120 Hours|Number of subjects in the Modified Intent-to-Treat Population with overall CR (0-120 hrs) in all cycles||participants with overall CR|||Number
724508|NCT00343460|Secondary|Severity of Nausea Daily and During Chemotherapy Course 1 (0-120 Hours)|Maximum severity of nausea, days 1-5|0-120 Hours|Severity of Nausea - Cycle 1 - Modified Intent-to-Treat Population||participants|||Number
724509|NCT00343460|Secondary|First and Overall Use of Rescue Medication||0-120 Hours|Cycle 1 - Modified Intent-to-Treat Population||participants|||Number
724510|NCT00343460|Secondary|Time to First Treatment Failure|Proportions of subjects event free at 24, 48, 72, 96, and 120 hours after chemotherapy administration|0-120 Hours|Proportions of subjects event free in Cycle 1 - Modified Intent-to-Treat Population||Proportion of subjects event free|||Number
724511|NCT00343460|Secondary|Number of Emetic Episodes|Number of Emetic Episodes - days 1-5|Days 1-5|Cycle 1 - Modified Intent-to-Treat Population||Number of Emetic Episodes||Standard Deviation|Mean
724512|NCT00343460|Secondary|Proportion of Patients With Total Response During the Acute Phase, Delayed-onset Phase, and During Chemotherapy Course 1|"TR during acute phase is defined as Complete Response with no nausea during 0 to 24 hours following the administration of chemotherapy in Cycle 1.
TR during delayed-onset phase is defined as Complete Response with no nausea during >24 to 120 hours following the administration of chemotherapy in Cycle 1. TR during overall risk period is defined as Complete Response with no nausea during 0 to 120 hours following the administration of chemotherapy in Cycle 1."|0-120 Hours|Cycle 1 - Modified Intent-to-Treat Population||participants|||Number
724513|NCT00343460|Secondary|Proportion of Patients With Complete Control During the Acute Phase (0-24 Hours), Delayed-onset Phase (24-120 Hours), and During Chemotherapy Course 1|Complete control is defined as complete response with no more than mild nausea.|0-120 Hours|Cycle 1 - Modified Intent-to-Treat Population||participants|||Number
724514|NCT00343460|Primary|Proportion of Patients With CR During Delayed-onset Phase (24-120 Hours) After Administration of Chemotherapy Course 1|Complete Response is defined as no emetic episodes and no use of rescue medications|24-120 Hours|Cycle 1 - Modified Intent-to-Treat Population||participants|||Number
724515|NCT00343460|Primary|Proportion of Patients With Complete Response (CR) During Acute Phase (0-24 Hours) After Administration of Chemotherapy Course 1|Complete Response is defined as no emetic episodes and no use of rescue medications|0-24 Hours|Cycle 1 - Modified Intent-to-Treat Population||participants|||Number
724537|NCT00343889|Primary|Number of Participants With Seroprotection to Hepatitis H Antigen After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV|"Immunogenicity was assessed by means of radioimmunoassay (RIA) for hepatitis B (HBs) antibodies.
Seroprotection was defined as titers ≥ 10 mIU/mL at 30 days after the third vaccination."|1 month post third vaccination|Seroprotection to hepatitis H Antigen was assessed in the per-protocol population.||Participants|||Number
724516|NCT00343512|Secondary|Tumor Response as Measured by Ultrasound|Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.|At screening, 8 weeks and at surgery (within 14-21 days)|||participants|||Number
724517|NCT00343512|Secondary|Safety Profile Based on Number of Patients With Each Worst-grade Toxicity|Not all participants necessarily have an adverse event, thus not everyone will be accounted for in worst-grade toxicities. Likewise, one participant can potentially have more than one event in various grades 1-5 which accounts for the difference in number of patients analyzed and total number in the worst-grade toxicity tables. Tables represent the number of patients with worst-grade toxicity at each of five grades (grade 1, least severe; to grade 5, most severe) following NCI Common Toxicity Criteria|Through 30 days after completion of treatment|||participants|||Number
724518|NCT00343512|Primary|Number Participants to Achieve Pathologic Complete Response|whether or not patient has pathologic complete response (pCR) to dose dense docetaxel in the neoadjuvant setting (pCR = no residual viable tumor on histologic analysis)|3 month|||participants|||Number
724519|NCT00343564|Secondary|Phase 1: Pharmacokinetics of SB-743921 Administered on a Days 1 and 15 of a 28 Day Cycle.||28 days||||||
724520|NCT00343564|Primary|Phase 1: Determination of Maximum Tolerated Dose (MTD) First Without and Then With Administration of Prophylactic G-CSF.|Maximum Tolerated Dose (MTD) was determined by testing increasing doses in cohorts with at least 3 patients each. MTD reflects the highest dose of drug that did not cause dose limiting toxicity (DLT).|28 days|Safety population; all patients who received at least 1 dose of study drug were included in the intent-to-treat/safety populations.||mg/m2|||Number
724521|NCT00343785|Secondary|Overall Survival|Number of patients alive at one year|From the time of enrollment until death from any cause up to one year|All Patients||Participants|||Count of Participants
724522|NCT00343785|Secondary|Number of Days to Neutrophil Recovery to >500/uL|First of 3 consecutive days of neutrophils >500/uL|100 days post-transplant|All patients||days||Full Range|Median
724523|NCT00343785|Primary|Incidence of Chronic GVHD|Analyzed using cumulative incidence estimates, treating death or rejection as competing risk events.|2 years|All Patients||number participants with chronic GVHD|||Number
724524|NCT00343863|Secondary|Quality of Life||Up to 3 months|||FLIE questionnaires|FLIE questionnaires||Count of Units
724525|NCT00343863|Secondary|Severity of Nausea|Count of participants with severe nausea|Up to 3 months|||Participants|||Count of Participants
724526|NCT00343863|Secondary|Side Effects of Antiemetic Medications Used||Up to 3 months|||Participants|||Count of Participants
724527|NCT00343863|Secondary|Number of Doses of Rescue Medications Used||Days 1-7 of each cycle|Patients were unable to consistently complete this part of the FLIE questionnaire and thus we did not retain data from any of the participants.|||||
724528|NCT00343863|Secondary|Number of Participants That Had First Administration of Rescue Medication Within 48 Hours|Count of patients that had first administration of rescue medication within 48 Hours|up to 48 hours of chemotherapy|||Participants|||Count of Participants
724529|NCT00343863|Secondary|Number of Participants That Had Emesis Within 48 Hours of Chemotherapy|Count of patients that had emesis within 48 hours of chemotherapy|Up to 48 hours of chemotherapy|||Participants|||Count of Participants
724530|NCT00343863|Secondary|Number of Days With Emetic Episodes and Rescue Medicines||Up to 3 months|||days||Full Range|Median
724531|NCT00343863|Secondary|Count of Patients Achieving Complete Response||At 24-120 hours after weekly intravenous doxorubicin|||Participants|||Count of Participants
724532|NCT00343863|Primary|Count of Patients Achieving a Complete Response||At 0-24 hours after weekly intravenous doxorubin|||Participants|||Count of Participants
724533|NCT00343889|Secondary|Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV|"Solicited injection site reactions: Tenderness, Erythema, and Swelling; Systemic reactions: Fever (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability.
Grade 3 reactions defined as: Tenderness - cries when injected limb is moved; Erythema and Swelling - ≥ 5cm; Fever - temperature ≥ 39.6ºC; Vomiting - ≥6 episodes per 24 hours; Crying - inconsolable crying for >3 hours; Somnolence - sleeping most of the time or difficulty to wake up; Anorexia - refuses ≥3 feeds; and Irritability - inconsolable."|Day 0 up to Day 7 after each vaccination|Safety was assessed on the safety analysis (intent-to-treat) population.||Participants|||Number
724534|NCT00343889|Secondary|Number of Participants With Seroconversion for Anti-Pertussis and Anti-Filamentous Hemagglutinin Antibodies After Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV|"Anti-Pertussis toxoid and Anti-Filamentous Hemagglutinin antibodies were assessed by means of enzyme immunoassay (EIA).
Seroconversion was defined as ≥ 4 fold increase in antibody titers from Day 0 to 30 days after the third vaccination."|1 month post third vaccination|Seroconversion for anti-Pertussis toxoid and anti-Filamentous Hemagglutinin antibodies were assessed in the per-protocol population.||Participants|||Number
724535|NCT00343889|Secondary|Number of Participants With Anti-Diphtheria and Anti-Tetanus Responses After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV|"Immunogenicity was assessed by means of radioimmunoassay (RIA) for Diphtheria and Tetanus antibodies.
Anti-Diphtheria and anti-tetanus Responses were assayed at ≥ 0.01 IU/mL and at ≥ 0.1 IU/mL at 30 days after the third vaccination."|1 month post third vaccination|Anti-Hepatitis B Responses was assessed in the per-protocol population.||Participants|||Number
724536|NCT00343889|Secondary|Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV|Immunogenicity were assessed by means of enzyme immunoassay (EIA) for antibodies to the vaccine antigens 1 month after the third vaccination (Day 150).|1 month post third vaccination|Geometric Mean Titers (GMTs) of Vaccine Antibodies were assessed in the per protocol population.||Titers||95% Confidence Interval|Geometric Mean
724590|NCT00345371|Primary|Abstinence (Weeks 6 - 12)|The number of participants who abstained from methamphetamine from weeks 6 through 12|weeks 6 through 12|||Participants|||Count of Participants
724538|NCT00343889|Secondary|Number of Participants With Anti-Hepatitis B Responses After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV|"Immunogenicity was assessed by means of radioimmunoassay (RIA) for hepatitis B (HBs) antibodies.
Anti-Hepatitis B Responses was defined as titers ≥ 100 mIU/mL at 30 days after the third vaccination."|1 month post third vaccination|Anti-Hepatitis B Responses was assessed in the per-protocol population.||Participants|||Number
724539|NCT00343915|Secondary|Number of Subjects With Serious Adverse Events (SAEs).|erious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.|At Month 30, Month 42, Month 54 & Month 66|LT total cohort included all subjects who were included in the total cohort in the primary study and returned at the considered follow-up time point.||Participants|||Number
724540|NCT00343915|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.|During the entire study period (Month 0 to Month 66)|Total Cohort included all enrolled (i.e. randomized or vaccinated) subjects who received at least one vaccine dose and for whom data were available. No information regarding AEs was available for 1 subject in each group.||Subjects|||Number
724541|NCT00343915|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Event (AE).|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|During the 31-day (Day 0-30) follow-up period after each vaccination and overall|Total Cohort included all enrolled (i.e. randomized or vaccinated) subjects who received at least one vaccine dose and for whom data were available. No information regarding AEs was available for 1 subject in each group||Subjects|||Number
724542|NCT00343915|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache, and fever. Any was defined as incidence of the specified symptoms regardless of intensity or relationship to study vaccine. Gastrointestinal symptoms included nausea, vomiting, diarrhea and abdominal pain. Grade 3 fever was defined as fever (axillary temperature) > 38.5°C. Grade 3 symptoms were defined as symptoms which prevented normal everyday activities. Related = general symptom assessed by the investigator as causally related to the vaccination.|During the 4-day (Day 0-3) follow-up period after each vaccination and overall|The ATP cohort for safety included all evaluable subjects, who received at least one dose of study vaccine according to their random assignment, with sufficient data to perform safety analysis, who did not receive a vaccine not specified or forbidden in the protocol.||Subjects|||Number
724543|NCT00343915|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.|During the 4-day (Day 0-3) follow-up period after each vaccination and overall|The ATP cohort for safety included all evaluable subjects, who received at least one dose of study vaccine according to their random assignment, with sufficient data to perform safety analysis, who did not receive a vaccine not specified or forbidden in the protocol.||Subjects|||Number
724544|NCT00343915|Secondary|Number of Subjects Seroprotected for Anti-HBs Antibody.|A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.|At Months 1, 2 and 6|The ATP cohort for immunogenicity included all evaluable subjects who had post-vaccination immunogenicity results and who complied with the protocol, including the time schedule for vaccination and blood sample draw.||Subjects|||Number
724545|NCT00343915|Secondary|Antibody Titers Against Hepatitis-B Virus.|Antibody titers were summarized by Geometric Mean Concentrations (GMCs) with their 95% CIs.|At Months 1, 2, 6 and 7|The ATP cohort for immunogenicity included all evaluable subjects who had post-vaccination immunogenicity results and who complied with the protocol, including the time schedule for vaccination and blood sample draw.||mIU/mL||95% Confidence Interval|Geometric Mean
724546|NCT00343915|Primary|Antibody Titers Against Hepatitis-B Virus.|Antibody titers were summarized by Geometric Mean Concentrations (GMCs) with their 95% CIs.|At Month 30, Month 42, Month 54 and Month 66|Long Term According-to-Protocol cohort for immunogenicity, including all subjects who returned at the considered follow-up time point and who complied with the protocol.||mIU/mL||95% Confidence Interval|Geometric Mean
724547|NCT00343915|Primary|Number of Subjects Seroprotected for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody.|A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.|At Month 30, Month 42, Month 54 and Month 66|Long Term According-to-Protocol cohort for immunogenicity, including all subjects who returned at the considered follow-up time point and who complied with the protocol.||Subjects|||Number
724548|NCT00343915|Primary|Number of Subjects Seroprotected for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody.|A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.|At Month 7|The ATP cohort for immunogenicity included all evaluable subjects who had post-vaccination immunogenicity results and who complied with the protocol, including the time schedule for vaccination and blood sample draw.||Subjects|||Number
724549|NCT00344487|Primary|Changes in the Slope of CD4 as Assessed 6 Months Prior to the Lopinavir/Ritonavir Switch (Baseline), Compared to 6-12 Month Intervals Post Initiation of Lopinavir/Ritonavir (Slope 1-6 Months, 1-12 Months)||6 and 12 months||||||
724550|NCT00344487|Primary|Baseline Will be Defined as the Mean of 2 Values Obtained Prior to the Medication Switch (for Analysis Purposes, the CD4 Cell Counts at 6 and 12 Months Will be Defined by the Mean of the CD4 Cell Counts Obtained at Months 3, 6 or 9, 12, Respectively).||3, 6, 0r 9, 12 months respectively||||||
724551|NCT00344487|Primary|Changes From Baseline in CD4 Cell Count at 6 and 12 Months||6 and 12 months||||||
724552|NCT00344487|Primary|Changes From Baseline in CD4 Cell Percentage at 6 and 12 Months||Baseline, 6 and 12 months|||Percentage of Cells||Standard Deviation|Mean
724553|NCT00344487|Primary|Absolute Change in CD4 Cell Count From Baseline, and at 6 and 12 Months||6 and 12 months||||||
724554|NCT00344500|Primary|Change in Predicted Trajectory of Mean Body Fat Percentage Per GLMM Analysis|Computed as % body fat at 12 month - % body fat at baseline. General Linear Mixed Model (GLMM) is a full information maximum likelihood approach that permits inclusion of all available data and provides unbiased parameter estimates even if there are missing data under the condition that data are missing at random. The GLMM approach assumes that every patient is on a specific trajectory over time and that both the slope and the shape of this trajectory are a potential function of group membership or other person-level covariates. Using a likelihood ratio test, we found a linear model, assuming the same rate of change throughout the study, provided a good fit to the data compared to other models. We used a linear model of the average rate of change over time (slope) for all comparisons. To illustrate the magnitude of difference between slopes for major outcomes, we report the estimated difference at 12 months between two hypothetical participants with identical baseline characteristics.|12 months|||Body Fat Percentage Change|||Number
724555|NCT00344500|Primary|Change in Predicted Trajectory of Mean BMI Per GLMM Analysis|General Linear Mixed Model (GLMM) is a full information maximum likelihood approach that permits inclusion of all available data and provides unbiased parameter estimates even if there are missing data under the condition that data are missing at random. The GLMM approach assumes that every patient is on a specific trajectory over time and that both the slope and the shape of this trajectory are a potential function of group membership or other person-level covariates. Using a likelihood ratio test, we compared different options to model these trajectories and found a linear model, which assumes that the same rate of change is maintained over the whole study, provided a good fit to the data. We used a linear model of the average rate of change over time (slope) for all comparisons. To illustrate the magnitude of difference between slopes for major outcomes, we report the estimated difference at 12 months between two hypothetical participants with identical baseline characteristics.|12 months|||kg/m^2|||Number
724556|NCT00344500|Primary|Mean Weight|Average weight of subjects attending each of the first 8 weekly visits and the 10 monthly visits which followed, per study group.|Weekly/Monthly, up to 1 year|All subjects who enrolled in this research program. Subjects were assessed weekly, when able. Since some were not able to do every weekly assessment, N varies weekly, and the weekly assessments below are the means of the number of subjects out of the total in the group who were assessed at that point.||Pounds||Standard Deviation|Mean
724557|NCT00344682|Secondary|Montgomery-Asberg Depression Rating Score (MADRS)|Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6 on 10 items. The overall score ranges from 0 to 60. Scores 0 to 6 indicate symptoms absent; 7 to 19 indicates mild depression; 30 to 34 defines moderate; 35 to 60 indicates severe depression. Changes in response rate and remission rate were assessed for secondary measures.|baseline and week 8|Secondary outcome examines a change in response rates,when 50% change from baseline, & remission rates, when MADRS scores of 12 or less were observed.Fischer exact tests assessed efficiency in each treatment group. Intent-to-treat rates at baseline minus week 8 through last observed data carried forward (LOCF) were used;no data values were imputed||units on a scale||Standard Deviation|Mean
724558|NCT00344682|Secondary|Hamilton Anxiety Rating Scale (HARS)|Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0–56, where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Scores > 30 indicate severe anxiety.|baseline & week 8|Secondary outcome examines a change in mean HARS scores observed at baseline & week 8 through last observed data carried forward (LOCF);no values were imputed for missing assessments.Efficacy data analysis used intent-to-treat measures & computes final study score minus baseline averaged among participants to evaluate treatment group differences||units on a scale||Standard Deviation|Mean
724559|NCT00344682|Secondary|Modified Quick Inventory of Depressive Symptoms Self Report Scale (QIDS-SR)|The 16 item Quick Inventory of Depressive Symptomatology (QIDS-SR16) (Rush et al. 2003) is designed to assess the severity of depressive symptoms, with higher scores representing more severe forms of depression. When complete, the QIDS are scored by summing responses to obtain a total score ranging from 0 to 27. Either appetite increase or decrease, but not both, are used to calculate the total score. Weight increase or decrease, but not both, are used to calculate the total score. Scores 0-5 indicate no severity of depression; 6-10 is mild; 11-15 is moderate; 16-20 is severe; 21-27 is very severe levels of depression. Participants were evaluated at baseline and at weeks 1, 2, 3, 4, 6 & 8.|baseline & week 8|The secondary outcome examines a change over in mean QID-SR scores at baseline & week 8 through last observed data carried forward (LOCF); no values were imputed for missing assessments. Data analysis used intent-to-treat measures and computes final study score minus baseline averaged among participants to evaluate treatment group differences.||units on a scale||Standard Deviation|Mean
724560|NCT00344682|Primary|Montgomery-Asberg Depression Rating Score (MADRS)|Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. Scores 0 to 6 indicate symptoms absent; 7 to 19 indicates mild depression; 30 to 34 defines moderate; 35 to 60 indicates severe depression. Changes in MADRS score was a primary measure.|Baseline & week 8|The primary outcome examines a mean change in MADRS scores at baseline & week 8 through last observation carried forward (LOCF); no values were imputed for missing assessments. The primary data analysis used intent-to-treat measures and computes final study score minus baseline averaged among participants to evaluate treatment group differences.||units on a scale||Standard Deviation|Mean
724561|NCT00344773|Secondary|Safety Profile: Participants With Adverse Events|Safety profile as defined by adverse events and serious adverse events throughtout the study period. Details listed in the SAE and Other AE section.|baseline to end of study||||||
724562|NCT00344773|Secondary|Overall Survival (OS)|Median Overal survival was not able to be calculated because the rate of OS was below 50% at the end of follow-up period. Therefore, OS percentage at 12 months is provided.|baseline to 12 months|||Percent of Participants|||Number
724563|NCT00344773|Secondary|Progression Free Survival (PFS)|Progression free survival calculated using Kaplan-Meier Product Limit. Median PFS was not able to be calculated because the rate of PFS was below 50% at the end of follow-up period. Therefore, PFS percentage at 4 months is provided.|baseline to 4 months|||Percent of Participants|||Number
724608|NCT00345605|Primary|Measures of Liver Function: PT and PTT|Prothrombin time (PT) and partial thromboplastin time (PTT) were measured PT measures factors I (fibrinogen), II (prothrombin), V, VII, and X, while PTT is a performance indicator of the efficacy of the common coagulation pathways.|Measured after each 1-week treatment period|||seconds||Inter-Quartile Range|Mean
724564|NCT00344773|Primary|Percentage of Participants Who Had an Objective Response Rate(ORR) Based on Response Evaluation Criteria In Solid Tumors (RECIST) Criteria.|"Objective Response Rate (ORR) is defined as participants who had complete response (CR) or partial response(PR) divided by the total number of patients.
RECIST criteria:
CR = disappearance of all target lesions PR = 30% decrease in the sum of the longest diameter of target lesions PD = 20% increase in the sum of the longest diameter of target lesions SD (stable disease) = small changes that do not meet above criteria"|baseline to 12 months|||Percent of Participants|||Number
724565|NCT00344968|Secondary|Retinal Thickness|Retinal images where sent to a reading center for analysis. Some images were not clear/distorted and could not be properly analyzed. This accounts for the discrepancy in the number of participants analyzed.|36 months|||microns||Standard Deviation|Mean
724566|NCT00344968|Primary|Visual Acuity|The percentage of subjects with an increase from baseline of 15 or more letters in best corrected visual acuity letter score as assessed by ETDRS eye chart (study eye).|36 months|Three subjects were randomized but did not receive treatment. These subjects were not included in the safety analysis, which accounts for the discrepancy in the overall number of participants.||percentage of subjects|||Number
724567|NCT00345033|Primary|Change in Insulin Resistance|A comparison between aripiprazole group and placebo group of change in insulin resistance measured at Baseline and Week 8.|Measured at Baseline and Week 8|The number of participants for analysis (intent to treat) were those that completed the study (N=30)||HOMA score||Standard Deviation|Mean
724568|NCT00345033|Primary|Change in Triglycerides||Measured at Baseline and Week 8|The number of participants for analysis (intent to treat) were those that completed the study (N=30)||mg/dL||Standard Deviation|Mean
724569|NCT00345033|Primary|Change in Glucose Metabolism|A comparison between the aripiprazole group and placebo group in change in glucose metabolism measured at Baseline and Week 8.|Measured at Baseline and Week 8|The number of participants for analysis (intent to treat) were those that completed the study (N=30).||min^-1||Standard Deviation|Mean
724570|NCT00345033|Primary|Change in Body Mass Index (BMI)|A comparison between aripiprazole group and placebo group of change in Body Mass Index (BMI) measured at Baseline and Week 8.|Measured at Baseline and Week 8|The number of participants for analysis (intent to treat) were those that completed the study (N=30).||kg/m^2||Standard Deviation|Mean
724571|NCT00345033|Primary|Change in Weight|A comparison between aripiprazole group and placebo group in change in weight measured at Baseline and Week 8.|Measured at Baseline and Week 8|The number of participants for analysis (intent to treat) were those that completed the study (N=30).||kg||Standard Deviation|Mean
724572|NCT00345033|Primary|Change in Total Cholesterol|A comparison of aripiprazole group and placebo group in change in total cholesterol measured at Baseline and Week 8.|Measured at Baseline and Week 8|The number of participants for analysis (intent to treat) were those that completed the study (N = 30).||mg/dL||Standard Deviation|Mean
724573|NCT00345046|Primary|Percent Change in Flare at Resolution||2 months|||Percent change in flare||Standard Deviation|Mean
724574|NCT00345176|Other Pre-specified|Genetics for the Progression of AMD and Cataract||5 years of follow-up||||||
724575|NCT00345176|Other Pre-specified|Genetics for the Association of AMD and Cataract||5 years of follow-up||||||
724576|NCT00345176|Other Pre-specified|Prevalence of Peripheral Changes as Measured Using OPTOS Imaging|Effects of oral supplementation of omega-3 fatty acids, lutein/zeaxanthin on the peripheral retina|5 years of follow-up||||||
724577|NCT00345176|Other Pre-specified|Cognition as Measured by a Telephone Battery|Effects of oral supplementation of omega-3 fatty acids, lutein/zeaxanthin, zinc, and beta-carotene on cognitive function|5 years of follow-up||||||
724578|NCT00345176|Other Pre-specified|Incident Cardiovascular Disease|Effects of oral supplementation of omega-3 fatty acids, lutein/zeaxanthin on cardiovascular disease|5 years of follow-up||||||
724579|NCT00345176|Secondary|Progression to Cataract Surgery|The study examined the effects of lutein/zeaxanthin on progression to cataract surgery with data collected during regular telephone contacts and the annual study visits.|5 years of follow-up|Includes participants who were phakic in at least 1 eye at baseline||Eyes|Participants||Number
724580|NCT00345176|Secondary|Adverse Events|Safety outcomes included serious adverse events and mortality.|5 years of follow-up|Number of deaths in 5 years||Participants|||Number
724581|NCT00345176|Secondary|Progression to Moderate Vision Loss|Loss defined as >/= 3 lines of letters from baseline or treatment for choroidal neovascularization|5 years of follow-up|||Eyes|Participants||Number
724582|NCT00345176|Primary|Development of Advanced AMD in People at Moderate to High Risk for Progression.|Defined as central geographic atrophy or retinal features of choroidal neovascularization detected on central grading of the stereoscopic fundus photographs or a history of treatment for advanced AMD after study enrollment.|5 years of follow-up|Intention to Treat. Participants lost to follow-up during the course of the study were censored at the time of last contact.||Eyes|Participants||Number
724583|NCT00345254|Primary|Umbilical Cord pH||immediately after delivery|||pH||Standard Deviation|Mean
724584|NCT00345293|Secondary|Clinical Response||Post treatment|This data was not collected due to differences in immunogenicity based on different dendritic cell preparations. This data was no longer relevant.|||||
724585|NCT00345293|Secondary|Immunogenicity|The Tritiated thymidine proliferation assay is used to assess samples collected pre-treatment and those collected post-treatment; the outcome measure is the change in counts per minute (post-treatment counts minus pre-treatment counts).|pre and post treatment|One other participant in DC/PC3 vaccine-Selected group not analyzed due to failed controls in assay.||counts per minute||Full Range|Median
724586|NCT00345293|Primary|Toxicity|adverse events|through week 29|||events|||Number
724587|NCT00345332|Secondary|Number of Incontinence Pads Used Per Day|The number of incontinence pads used per day per day was recorded by each participant in a diary.|week 13|||pads per day||Standard Error|Geometric Least Squares Mean
724588|NCT00345332|Primary|Incontinent Episodes Per Day|The number of incontinence episodes per day was recorded by each participant in a diary. All incontinence episodes were counted when calculating episodes per day at each time point.|week 13|||incontinence episodes per day||Standard Error|Geometric Least Squares Mean
724589|NCT00345371|Secondary|Abstinence (Weeks 1 - 12)|Number of participants who abstained from methamphetamine from weeks 1 through 12|Weeks 1 through 12|||Participants|||Count of Participants
724609|NCT00345605|Secondary|Urea Production Rate||Measured after each 1-week treatment period|||micromoles/kg/hr||Standard Deviation|Mean
724591|NCT00345384|Secondary|Measure the Amount of Respiratory Depression in Each Groups|Respiratory depression and deep levels of sedation can occur when morphine patient-controlled analgesia is prescribed for postoperative patients. In this secondary outcome measure, it was hypothesized that the addition of a dexmedetomidine infusion to the postoperative pain management protocol would reduce the amount of morphine delivered by a PCA pump while providing adequate analgesia. Data are reported for the time period 6 to 16 hours. However, the subjects were on the study for an average of 24 hours, up to 30 hours.|Hours 6 to 16|||mmHg||Standard Deviation|Mean
724592|NCT00345384|Primary|Measure Any Reduction in the Amount of Opioid Administered to Patients in the Dexmedetomidine Study Arm.|To measure the amount of opioid use requested by patients enrolled in the dexmedetomidine study arm during the observation period of 24 hours, up to 30 hours per patient.|An average of 24 hours, up to 30 hours per patient|Participants completing the study were analyzed as per protocol||IV morphine equivalency in mg||95% Confidence Interval|Number
724593|NCT00345397|Primary|Change in Bowel QoL|"Spinal Cord Injury (SCI) -Specific, 20-Question QoL Instrument used a Visual Analog Scale (VAS) for each item.
These were scored by measurement and recording 1-10 along the scale (1 being best, 10 being worst) An average of the scores for the 20-items was calculated for each subject before and after Percutaneous Endoscopic Colostomy (PEC) Tube placement.
A Global SCI-QoL Score was also recorded using the same VAS. The difference between these Intake and Exit scores was used to define change in SCI-Specific Quality of Life."|Exit data collected 1 year(+/- 6 mo) after Intake data collection / PEC placement|Subjects completing both Intake and Exit assessments||units on a scale||Standard Deviation|Mean
724594|NCT00345540|Secondary|Progression Free Survival (PFS)||From time of treatment start to time of disease progression|||Weeks||Full Range|Mean
724595|NCT00345540|Secondary|Safety of NOV-002 and Carboplatin||Duration of trial and through 30-day follow-up period after final treatment|||Adverse Events|||Number
724596|NCT00345540|Primary|Response Rate||At treatment completion (8 weeks) and monthly until disease progression|||Participants|||Number
724597|NCT00345579|Primary|Number of Subjects With Adverse Events Resulting in Emergency Room (ER)||From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)|The Primary Total Vaccinated cohort included all subjects with at least one primary vaccine dose of study vaccine administered.||Subjects|||Number
724598|NCT00345579|Primary|Number of Subjects With Rash|Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae|From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)|The Primary Total Vaccinated cohort included all subjects with at least one primary vaccine dose of study vaccine administered.||Subjects|||Number
724599|NCT00345579|Primary|Number of Subjects With New Onset of Chronic Illnesses (NOCIs)|NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.|From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)|The Primary Total Vaccinated cohort included all subjects with at least one primary vaccine dose of study vaccine administered.||Subjects|||Number
724600|NCT00345579|Primary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)|The Primary Total Vaccinated cohort included all subjects with at least one primary vaccine dose of study vaccine administered.||Subjects|||Number
724601|NCT00345579|Primary|Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER)||From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5)|The Primary Total Vaccinated cohort included all subjects with at least one primary vaccine dose of study vaccine administered.||Subjects|||Number
724602|NCT00345579|Primary|Number of Subjects Reporting Rash|Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae.|From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5)|The Primary Total Vaccinated cohort included all subjects with at least one primary vaccine dose of study vaccine administered.||Subjects|||Number
724603|NCT00345579|Primary|Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs)|NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.|From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5)|The Primary Total Vaccinated cohort included all subjects with at least one primary vaccine dose of study vaccine administered.||Subjects|||Number
724604|NCT00345579|Primary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5)|The Primary Total Vaccinated cohort included all subjects with at least one primary vaccine dose of study vaccine administered.||Subjects|||Number
724605|NCT00345592|Primary|Unplanned Hospital Admissions for Cardiac Reasons OR Death of Cardiovascular Causes OR Progression to Chronic Atrial Fibrillation||3 years from randomization (39 months total)|||participants|||Number
724606|NCT00345605|Primary|Measures of Liver Function: INR|The result (in seconds) for a prothrombin time performed on a normal individual will vary according to the type of analytical system employed. This is due to the variations between different batches of manufacturer's tissue factor used in the reagent to perform the test. The INR was devised to standardize the results. Each manufacturer assigns an ISI value (International Sensitivity Index) for any tissue factor they manufacture. The ISI value indicates how a particular batch of tissue factor compares to an international reference tissue factor. The ISI is usually between 1.0 and 2.0. The INR is the ratio of a patient's prothrombin time to a normal (control) sample, raised to the power of the ISI value for the analytical system being used.|Measured after each 1-week treatment period|||seconds||Inter-Quartile Range|Mean
724607|NCT00345605|Primary|Measures of Liver Function: Coagulation Factors|Plasma levels of coagulation factors I and IX were used as measures of hepatic synthetic function since the treatment duration was short.|Measured after each 1-week treatment period|||mg/dL||Standard Deviation|Mean
724610|NCT00345605|Secondary|Arginine Levels||Measured after each 1-week treatment period|||micromoles/L||Inter-Quartile Range|Median
724611|NCT00345605|Secondary|Argininosuccinic Acid Levels||Measured after each 1-week treatment period|||micromole/l||Inter-Quartile Range|Median
724613|NCT00345631|Secondary|Percentage of Patients Who Experienced Any Other Vascular Closure Related Adverse Events|Other known vascular closure related adverse events include: Rebleeding Following Initial Hemostasis; Access Site Hematoma >= 6cm; Access Site-Related Bleeding Requiring > 30 min for Hemostasis; Transient Access Site-Related Nerve Injury; Retroperitonea Bleeding; Decrease in Pedal Pulse|From end of vessel closure procedure to 30 days post-procedure|Intent to treat population||Percentage of participants|||Number
724614|NCT00345631|Secondary|Percent of Patients Who Achieved Procedure Success During 30 Days Post-procedure|Procedure success is defined as initial hemostasis achieved by the assigned method Vascular Closure Device (VCD) or Manual compression (MC) with none of the primary safety endpoint’s closure related major adverse events (MAE). Procedural success is assessed on day of catheterization procedure and at 30 days post-procedure.|From catheterization procedure to 30 day post-procedure follow up|Intent to Treat Population||Percentage of participants|||Number
724615|NCT00345631|Secondary|Percentage of Patients Who Achieved Device Success Within Five Minutes Post-procedure|Device Success is defined as the successful deployment of the plug, initial hemostasis time less or equal to 5 minutes, and removal of the intact delivery system.|Within 5 minutes post-procedure|Intent to treat population (ITT) excluding the Manual Compression (MC) patients since MC Patients didn't deploy the device.||Percentage of participants|||Number
724616|NCT00345631|Secondary|Time to Device Deployment, up to 5 Minutes|Time to device deployment is defined as from the time device inserted to the time sheath removed|From device inserted to introducer sheath removal|Intent to Treat population with non-missing time data, excluding MC patients. Patients in the MC arm didn't deploy the device.||Hour||Standard Deviation|Mean
724617|NCT00345631|Secondary|Time to Hospital Discharge|Time to hospital discharge is defined as from the time of sheath removal to the time of hospital discharge|From introducer sheath removal to patient discharge|Intent to Treat population with non-missing time data||Hour||Standard Deviation|Mean
724618|NCT00345631|Secondary|Time to Eligibility for Hospital Discharge|Time to Eligibility for Hospital Discharge is measured from the time of sheath removal to the time when the patient is eligible for discharge according to the judgment of the patient’s physician.|From introducer sheath removal to hospital discharge, up to 284 hours|Intent to treat population with non-missing time data||Hour||Standard Deviation|Mean
724619|NCT00345631|Primary|Percentage of Patients Who Experience Any Vascular Closure Related Major Adverse Events During the 30 Days Post-procedure|Vascular closure related major adverse events consist of any of the events below: Vascular repair or the need for repair; access site-related bleeding requiring transfusion; access site-related infection requiring intravenous/intramuscular antibiotics and/or extended hospitalization; any new ipsilateral lower extremity ischemia documented by symptoms, physical exam, and/or decreased or absent blood flow on lower extremity angiogram; surgery for access site-related nerve injury; and Permanent (> 30 days) access site-related nerve injury.|From post-procedure to 30 days follow up|Intent to treat population||Percentage of participants|||Number
724620|NCT00345631|Primary|Time to Ambulation (TTA)|Time to ambulation is defined as the time from when the introducer sheath was removed to the time that ambulation was achieved. Ambulation is defined as patient standing and walking at least 20 feet without re-bleeding or significant oozing requiring manual compression. Time to ambulation is one of the two co-primary endpoints.|From when the introducer sheath was removed to 30 days post-procedure|Intent to Treat (ITT)Population with non-missing time to ambulation data.||Hours||Standard Deviation|Mean
724621|NCT00345631|Primary|Time to Hemostasis (TTH)|Time to hemostasis is defined as time (in minutes) from when the introducer sheath was removed to the time that hemostasis was first observed during post-procedure follow up. Hemostasis is defined as no or minimal subcutaneous oozing and the absence of expanding or developing hematoma. Time to hemostasis is one of the two co-primary endpoints.|From when the introducer sheath was removed to the time hemostasis was first observed|Intent to treat population (ITT) with non-missing time to hemostasis data. ITT population consists of all randomized (VCD and MC) patients where a femoral artery closure procedure is attempted post-randomization.||Minutes||Standard Deviation|Mean
724622|NCT00345683|Primary|Number of Subjects With Adverse Events Resulting in Emergency Room (ER) Visits||From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)|The Fourth dose Total Vaccinated cohort included all subjects who received the fourth study dose.||Subjects|||Number
724623|NCT00345683|Primary|Number of Subjects With Rash|Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae|From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)|The Fourth dose Total Vaccinated cohort included all subjects who received the fourth study dose.||Subjects|||Number
724624|NCT00345683|Primary|Number of Subjects With New Onset of Chronic Illnesses (NOCIs)|NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.|From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)|The Fourth dose Total Vaccinated cohort included all subjects who received the fourth study dose.||Subjects|||Number
724625|NCT00345683|Primary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)|The Fourth dose Total Vaccinated cohort included all subjects who received the fourth study dose.||Subjects|||Number
724626|NCT00345683|Primary|Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits||From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14)|The Fourth dose Total Vaccinated cohort included all subjects who received the fourth study dose.||Subjects|||Number
724627|NCT00345683|Primary|Number of Subjects Reporting Rash|Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae|From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14)|The Fourth dose Total Vaccinated cohort included all subjects who received the fourth study dose.||Subjects|||Number
724628|NCT00345683|Primary|Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs)|NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.|From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14)|The Fourth dose Total Vaccinated cohort included all subjects who received the fourth study dose.||Subjects|||Number
724629|NCT00345683|Primary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14)|The Fourth dose Total Vaccinated cohort included all subjects who received the fourth study dose.||Subjects|||Number
724630|NCT00345839|Secondary|Time to Parathyroidectomy|Time to Parathyroidectomy. Stratified by history of diabetes and country.|From date of randomization until date of first confirmed parathyroidectomy endpoint event, assessed up to 5.4 years|Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method.||Months||Inter-Quartile Range|Median
724631|NCT00345839|Secondary|Time to Bone Fracture|Time to Bone Fracture. Stratified by history of diabetes and country.|From date of randomization until date of first confirmed bone fracture endpoint event, assessed up to 5.4 years|Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method.||Months||Inter-Quartile Range|Median
724632|NCT00345839|Secondary|Time to Stroke|Time to Stroke. Stratified by history of diabetes and country.|From date of randomization until date of first confirmed stroke endpoint event, assessed up to 5.4 years|Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method.||Months||Inter-Quartile Range|Median
724633|NCT00345839|Secondary|Time to Cardiovascular Mortality|Time to Cardiovascular Mortality. Stratified by history of diabetes and country.|From date of randomization until date of first confirmed cardiovascular mortality endpoint event, assessed up to 5.4 years|Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method.||Months||Inter-Quartile Range|Median
724634|NCT00345839|Secondary|Time to Peripheral Vascular Event|Time to Peripheral Vascular Event. Stratified by history of diabetes and country.|From date of randomization until date of first confirmed peripheral vascular endpoint event, assessed up to 5.4 years|Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method.||Months||Inter-Quartile Range|Median
724635|NCT00345839|Secondary|Time to Heart Failure|Time to Heart Failure. Stratified by history of diabetes and country.|From date of randomization until date of first confirmed heart failure endpoint event, assessed up to 5.4 years|Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method.||Months||Inter-Quartile Range|Median
724636|NCT00345839|Secondary|Time to Hospitalization for Unstable Angina|Time to Hospitalization for Unstable Angina. Stratified by history of diabetes and country.|From date of randomization until date of first confirmed hospitalization for unstable angina endpoint event, assessed up to 5.4 years|Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method.||Months||Inter-Quartile Range|Median
724637|NCT00345839|Secondary|Time to Myocardial Infarction|Time to Myocardial Infarction. Stratified by history of diabetes and country.|From date of randomization until date of first confirmed myocardial infarction endpoint event, assessed up to 5.4 years|Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method.||Months||Inter-Quartile Range|Median
724638|NCT00345839|Secondary|Time to All-cause Mortality|Time to All-cause Mortality. Stratified by history of diabetes and country.|From date of randomization until date of confirmed all-cause mortality endpoint event, assessed up to 5.4 years|Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method.||Months||Inter-Quartile Range|Median
724639|NCT00345839|Primary|Time to Primary Composite Endpoint (All-cause Mortality, Myocardial Infarction, Hospitalization for Unstable Angina, Heart Failure or Peripheral Vascular Event)|Time to Primary Composite Endpoint (All-cause Mortality, Myocardial Infarction, Hospitalization for Unstable Angina, Heart Failure or Peripheral Vascular Event). Stratified by history of diabetes and country.|From date of randomization until date of first confirmed primary composite endpoint event, assessed up to 5.4 years|Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method.||Months||Inter-Quartile Range|Median
724640|NCT00345878|Secondary|Number of Subjects Reporting Serious Adverse Events|Serious adverse events assessed include medical occurrences that results in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Throughout the study period (up to Month 7)|||Subjects|||Number
724641|NCT00345878|Secondary|Number of Subjects Reporting Unsolicited Adverse Events as New Onset Chronic Diseases (NOCDs) and Other Medically Significant Adverse Events (AEs)|"NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes, allergies,...
Medically significant AEs assessed include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or SAEs that are not related to common diseases."|Throughout the study period (up to Month 7)|||Subjects|||Number
724642|NCT00345878|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|"Unsolicited adverse event = Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event."|Within 30 days after any vaccination|||Subjects|||Number
724643|NCT00345878|Secondary|Number of Subjects Reporting Solicited Symptoms|Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include arthralgia, fatigue, fever, gastro-intestinal symptoms, headache, myalgia, rash and urticaria.|During the 7 days after each vaccination|The analysis was performed on the Total Vaccinated Cohort, on subjects with available data.||Subjects|||Number
724645|NCT00345878|Primary|Number of Subjects Who Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies|Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subjects seronegative before vaccination. Cut-off values assessed include 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.|At Month 7|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.||Subjects|||Number
724646|NCT00346034|Primary|Change From Baseline to Week 12 in Pain Visual Analog Scale (VAS) Score|Mean Change: Observation VAS score minus Baseline score. Pain VAS is a 100mm horizontal line used to rate (score) pain by subject from 0 “no pain” to 100 “worst possible pain”. Baseline=value @ double-blind screening if randomized to pregabalin during double-blind OR value @ last visit from double-blind if randomized to placebo during double-blind.|Week 12 (end of treatment)|This will include all patients who have received at least one dose of study medication and observations at both baseline and week 12.||mm||Standard Deviation|Mean
724647|NCT00346034|Primary|Change From Baseline to Week 4 in Pain Visual Analog Scale (VAS) Score|Mean Change: Observation VAS score minus Baseline score. Pain VAS: 100 mm horizontal line to rate (score) pain from 0 “no pain” to 100 “worst possible pain”. Baseline = value @ double-blind screening if randomized to pregabalin during double-blind or value @ last visit from double-blind if randomized to placebo during double-blind.|Week 4|This will include all patients who have received at least one dose of study medication and had observations at both baseline and week 4.||mm||Standard Deviation|Mean
724648|NCT00346151|Secondary|Proportion of Participants With Post-transplant Diabetes Mellitus||Participants followed from transplantation until completion of study (up to four years post-transplantation)|Intent to Treat Sample||Participants|||Number
724649|NCT00346151|Secondary|Proportion of Participants With Delayed Graft Function||Participants followed from transplantation until completion of study (up to four years post-transplantation)|Intent to Treat Sample||Participants|||Number
724650|NCT00346151|Secondary|Proportion of Participants With Chronic Allograft Nephropathy||Participants followed from transplantation until completion of study (up to four years post-transplantation)|Intent to Treat Sample||Participants|||Number
724651|NCT00346151|Secondary|Proportion of Participants With a Sirolimus Associated Adverse Event||Participants followed from transplantation until completion of study (up to four years post-transplantation)|Intent to Treat Sample||Participants|||Number
724652|NCT00346151|Secondary|Proportion of Participants With Malignancies||Participants followed from transplantation until completion of study (up to four years post-transplantation)|Intent to Treat Sample||Participants|||Number
724653|NCT00346151|Secondary|Proportion of Participants With Wound Complications||Start of study to end of study|Intent to Treat Sample||Participants|||Number
724654|NCT00346151|Secondary|Proportion of Participants With Post-transplant Infections|Proportion of participants who experienced infections post-transplant. Participants were checked for any type of opportunistic infection at all study visits post-transplantation (up to 4 years post-transplantation)|Participants followed from transplantation until completion of study (up to four years post-transplantation)|Intent to Treat Sample||Participants|||Number
724655|NCT00346151|Secondary|Proportion of Participants Requiring Antilymphocyte Therapy for Acute Rejection|"Proportion of participants who experienced acute rejection[1] requiring antilymphocyte therapy
Diagnosis of acute rejection was made by renal (kidney) biopsy using the Banff 97 criteria. The Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Acute rejection is defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater[2]
Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713–723, 1999"|Participants followed from transplantation until completion of study (up to four years post-transplantation)|Intent to Treat Sample||Participants|||Number
724656|NCT00346151|Secondary|Time From Transplant to Acute Rejection|"Time (days) from transplant to occurrence of acute rejection[1]
Diagnosis of acute rejection was made by renal (kidney) biopsy using the Banff 97 criteria. The Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Acute rejection is defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater[2]
Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713–723, 1999"|Transplantation until rejection occurs (participants followed up to four years post-transplantation)|Intent to treat sample participants with rejection||Days||Full Range|Median
724657|NCT00346151|Secondary|Graft Survival at 12 Months Post-transplant||12 months post-transplant|Intent to treat sample participants not terminating prior to 12 months||Participants|||Number
724658|NCT00346151|Secondary|Renal Function as Measured by Glomerular Filtration Rate (GFR) at 24 Weeks|"GFR utilizing clearance of iothalamate.
GFR is an index of level of kidney function. A higher value means better kidney function."|24 weeks post-transplant|Intent to Treat Sample||mL/min/1.73m^2||Standard Deviation|Mean
724659|NCT00346151|Secondary|Tolerance Induction|Time from transplantation to initiation of sirolimus withdrawal.|48 months|Intent to treat sample that initiated sirolimus withdrawal||Days|||Number
724660|NCT00346151|Secondary|Acute Rejection at 12-Months|"Incidence of acute rejection[1] at 12 months post-transplant
Diagnosis of acute rejection was made by renal (kidney) biopsy using the Banff 97 criteria. The Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Acute rejection is defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater[2]
Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713–723, 1999"|12 months post-transplant|Intent to Treat Sample||Participants|||Number
724661|NCT00346151|Secondary|Participant Survival at 12 Months Post-Transplant||12 months post-transplant|Intent to Treat Sample participants not terminating prior to 12 months.||Participants|||Number
724678|NCT00346216|Secondary|The First Occurrence of a Major Adverse Cardiovascular Events (MACE)|MACE defined as the composite of CV death (including hemorrhagic death), non-fatal MI, non-fatal stroke, hospitalization for UA, revascularization or hospitalization for TIA|ITT Population - 30 months; MITT Population - 42 months|"ITT - The ITT population will consist of all subjects randomized for participation in the study.
MITT - The MITT analysis population consisted of all randomized subjects who had received at least one dose of study drug, and contributed at least one post-baseline visit."||Percentage of Participants|||Number
724662|NCT00346151|Primary|Acute Rejection at 6-Months|"Cumulative incidence of acute rejection[1] at 6 months post-transplant based on local pathology biopsy reads
Diagnosis of acute rejection was made by renal (kidney) biopsy using the Banff 97 criteria. The Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Acute rejection is defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater[2]
Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713–723, 1999"|6 months post-transplant|Intent to Treat||Participants|||Number
724663|NCT00346164|Secondary|Degree of Agreement in Histologic Grade Between Pediatric Oncology Group (POG) and Fédération Nationale Des Centres de Lutte Contre le Cancer (FNCLCC) Pathologic Grading Systems|POG and FNCLCC grades were determined by pathologists based on published standards. A higher grade is associated with a more severe disease.|At diagnosis|Ineligible patients, as well as patients without histologic grade determined by POG or FNCLCC were excluded. The OM evaluates the degree of agreement of two pathology grading systems applied at diagnosis. The time frame “At diagnosis” reflects the OM.||Participants|||Count of Participants
724664|NCT00346164|Secondary|Degree of Agreement in Histologic Grade Determined by the Enrolling Institution Versus by Central Pathology Reviewers|Histologic grades were determined by the central pathology reviewers and institutional pathologists based on published standards. A higher grade is associated with a more severe disease.|At Diagnosis|Ineligible patients, as well as patients without histologic grade determined by enrolling institution or central pathology reviewers were excluded. The OM evaluates the degree of agreement of two pathology grading reviews at diagnosis. The time frame “At diagnosis” reflects the OM.||Participants|||Number
724665|NCT00346164|Secondary|Genetic and Gene Expression Profiles|The tumors from patients registered on D9902 will be analyzed for genetic and gene expression profiles. The study will prospectively evaluate each tumor and confirm newly defined sarcoma diagnostic criteria based on cancer signatures in NRSTS.|At diagnosis|None of the tumors were analyzed for genetic and gene expression profiles. The analysis will not be completed. The time frame “At diagnosis” is the time frame for the gene expression profiles.|||||
724666|NCT00346164|Secondary|Incidence of Distant Metastasis|Percent of patients who had distant metastasis.|Up to 10 years|94 participants were excluded because of ineligibility, incorrect treatment, or absence of evaluation for tumor invasiveness and histologic grade.||Percentage of participants||95% Confidence Interval|Number
724667|NCT00346164|Secondary|Incidence of Distant Metastasis|Percent of patients who had distant metastasis.|Up to 10 years|94 participants were excluded because of ineligibility, incorrect treatment, or absence of evaluation for tumor invasiveness and histologic grade.||Percentage of participants||95% Confidence Interval|Number
724668|NCT00346164|Secondary|Overall Survival Probability Extent of Resection of the Primary Tumor|Probability of survival after 5 years since enrollment.|5 years|94 participants were excluded because of ineligibility, incorrect treatment, or absence of evaluation for tumor invasiveness and histologic grade.||Probability||95% Confidence Interval|Number
724669|NCT00346164|Secondary|Overall Survival Probability Disease Extent|Probability of survival after 5 years since enrollment.|5 years|94 participants were excluded because of ineligibility, incorrect treatment, or absence of evaluation for tumor invasiveness and histologic grade.||Probability||95% Confidence Interval|Number
724670|NCT00346164|Secondary|Event Free Survival Probability Histologic Grade|Probability of no relapse, secondary malignancy or death after 5 years since enrollment|5 years|94 participants were excluded because of ineligibility, incorrect treatment, or absence of evaluation for tumor invasiveness and histologic grade.||Probability||95% Confidence Interval|Number
724671|NCT00346164|Secondary|Event Free Survival Probability Disease Extent|Probability of no relapse, secondary malignancy or death after 5 years since enrollment.|5 years|94 participants were excluded because of ineligibility, incorrect treatment, or absence of evaluation for tumor invasiveness and histologic grade.||Probability||95% Confidence Interval|Number
724672|NCT00346164|Secondary|Percent Tumor Necrosis|Percent tumor necrosis by pathology review.|13 weeks|Only Arm D patients were evaluated at week 13 for percent tumor necrosis. Ineligible and inevaluable Arm D patients were excluded.||percentage of tumor necrosis||Standard Deviation|Mean
724673|NCT00346164|Secondary|Complete or Partial Response Rate|Tumor response by imaging. Complete Response (CR): Complete disappearance of the tumor. Partial Response (PR): At least 64% decrease in volume compared to the measurement obtained at study enrollment. Overall Response (OR)=CR+PR.|13 weeks|Only Arm D patients were evaluated for imaging response at week 13 after surgery. Ineligible and inevaluable Arm D patients were excluded.||percentage of patients||95% Confidence Interval|Number
724674|NCT00346164|Secondary|Toxicity Rate|Percentage of Arm D patients experiencing grade 4+ adverse events.|13 weeks|Excluding ineligible patients and patients not treated based on the protocol.||percentage of participants||95% Confidence Interval|Number
724675|NCT00346164|Primary|Probability for Event Free Survival.|Probability of no relapse, secondary malignancy or death after 5 years since enrollment.|5 years|Ineligible patients are excluded as well as patients who were treated on the incorrect arm.||Probability of EFS at 5 years||95% Confidence Interval|Number
724676|NCT00346216|Secondary|Change From Baseline in Patient’s Assessment of Arthritis Pain (VAS)|"VAS question How much pain do you have was graded on a scale from 0 to 100 with 0 indicating No pain and 100 indicating Worst possible pain."|ITT and MITT Population - Baseline to 42 months|"ITT - The ITT population will consist of all subjects randomized for participation in the study.
MITT - The MITT analysis population consisted of all randomized subjects who had received at least one dose of study drug, and contributed at least one post-baseline visit."||Number of participants||Standard Deviation|Mean
724677|NCT00346216|Secondary|The First Occurrence of Clinically Significant Gastrointestinal Events (CSGIE)|CSGIE include: Gastroduodenal (GD) hemorrhage, Gastric outlet obstruction, Gastroduodenal, small bowel or large bowel perforation, Large bowel hemorrhage, Small bowel hemorrhage, Acute GI hemorrhage of unknown origin, including presumed small bowel hemorrhage, Symptomatic gastric or duodenal ulcer|ITT Population - 30 months; MITT Population - 42 months|"ITT - The ITT population will consist of all subjects randomized for participation in the study.
MITT - The MITT analysis population consisted of all randomized subjects who had received at least one dose of study drug, and contributed at least one post-baseline visit."||Percentage of Participants|||Number
724710|NCT00346632|Secondary|Terminal Half Life (t 1/2)||Days 1 and 14 (and Day 28 for Arm B) of Cycle 1|||hours||Standard Deviation|Mean
724679|NCT00346216|Primary|The First Occurrence of Antiplatelet Trialists Collaboration (APTC) Composite Endpoint, Confirmed by the Clinical Events Committee (CEC).|APTC events are defined as a composite of any of the following events: Death due to CV causes (including cardiac, cerebrovascular, venous thromboembolic, haemorrhagic, other vascular, or unknown cause); Non-fatal MI; Non-fatal stroke (including intracranial hemorrhages, stroke of ischemic or unknown etiology).|Intent to Treat (ITT) Population - 30 months; Modified ITT (MITT) Population - 42 months|"ITT - The ITT population will consist of all subjects randomized for participation in the study.
MITT - The MITT analysis population consisted of all randomized subjects who had received at least one dose of study drug, and contributed at least one post-baseline visit."||Percentage of Partcipants|||Number
724680|NCT00346268|Other Pre-specified|Total Amount of Postoperative Drainage Fluid|After removal of the prostate and placement of the urine catheter, at least one easy-flow drainage was placed in the perivesical space. Drainage fluid (a mixture with a variable combination of blood and urine) was measured.|24 hours post surgery|Data not analyzed due to study termination.||mL|||Number
724681|NCT00346268|Other Pre-specified|Hemoglobin Concentration||24 hours post surgery|Data not analyzed due to study termination.||g/dL|||Number
724682|NCT00346268|Other Pre-specified|Overall Analgesic Benefit Score (OABS)|Participants' rating of global assessment of analgesic experience. OABS comprised of scores for symptoms (vomiting, itching, sweating, freezing, and dizziness) and patient satisfaction; Participants asked how much did symptoms distress and bother them during the last 24 hours; Participants asked how satisfied they have been with treatment of pain during last 24 hours. Each symptom and satisfaction question scored from 0 (not at all) to 4 (very much so). Total possible score=0 to 24.|24 and 48 hours post surgery|Data not analyzed due to study termination.||scores on a scale|||Number
724683|NCT00346268|Other Pre-specified|Number of Participants With Health Care Resource Utilization (HCRU)|"Supervising physician or nurse answered question in the presence of participant, In the last 24 hours, did the participant receive any unscheduled consultation from any of the following specialist: anesthesiologist, surgeon, nurse or other specialist."|24 and 48 hours post surgery|Data not analyzed due to study termination.||participants|||Number
724684|NCT00346268|Other Pre-specified|Number of Participants With Rating of Global Evaluation of Study Medication|"Participants asked, “How would you rate the study medication you received for pain since your surgery? choices included: Poor, Fair, Good, and Excellent."|48 hours post surgery|FAS; N=participants with evaluable data.||participants|||Number
724685|NCT00346268|Secondary|Opiate Related Symptom Distress Scale (OR-SDS) Questionnaire: Overall Composite Score|Participant-rated scale assessed 10 common opiate related symptoms by 3 ordinal measures: frequency (1 to 4 scale: rarely to almost constantly), severity (1 to 4 scale: slight to very severe) and bothersomeness (1 to 5 scale: not at all to very much). Frequency and severity items assigned numeric scores 1 to 4. Bothersomeness items scaled in order to assign numeric scores 0.8 to 4.0 (not at all scored=0.8, a little bit=1.6, somewhat=2.4, quite a bit=3.2, and very much=4.0). Overall composite score=mean of each 10 individual mean symptoms’ OR-SDS scores; ranged from 1 to 4.|24 and 48 hours post surgery|FAS; N=participants with evaluable data.||scores on scale||Standard Deviation|Mean
724686|NCT00346268|Secondary|Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Interference Composite Score|mBPI-sf: participant-rated 11-point Likert rating scale ranging from 0 (does not interfere) to 10 (completely interferes) with functional activities (general activity, mood, walking ability, relations with other people, sleep, coughing, deep breathing, and concentration) in past 24 hours.|24 and 48 hours post surgery|FAS; N=participants with evaluable data; n=participants with evaluable data for specified category; for analyses, missing values imputed using LOCF method.||scores on a scale||Standard Deviation|Mean
724687|NCT00346268|Secondary|Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Severity Composite Score|mBPI-sf: participant-rated 11-point Likert rating scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). Pain severity index=the mean of item scores 2 to 5 (pain at its worst in past 24 hours, pain at its least in past 24 hours, average pain level, and pain right now).|24 and 48 hours post surgery|FAS; N=participants with evaluable data; n=participants with evaluable for specified category; for analyses, missing values imputed using Last-Observation-Carried-Forward (LOCF) method.||scores on a scale||Standard Deviation|Mean
724688|NCT00346268|Secondary|Pain Intensity Score|"Pain intensity assessed immediately prior and 30 minutes after administration (admin) of study medication, participants categorized their pain intensity at rest and at movement on 0-4 numeric rating scale (NRS):0 (minimum intensity) to 4 (maximum intensity).
Movement defined as sitting up from a lying into a sitting position in bed."|12, 24, 36, and 48 hours post surgery|FAS; N=participants with evaluable data||scores on a scale||Standard Deviation|Mean
724689|NCT00346268|Secondary|Number of Participants With Blood Loss Requiring Red Blood Cell (RBC) Transfused Units||48 hours post surgery|FAS||participants|||Number
724690|NCT00346268|Secondary|Amount of Blood Loss|Calculated as: ([Hb g/dL]pra + RBCUduring48)-[Hb g/dL]at 48, where [Hb g/dL]pra=blood hemoglobin concentration preoperatively in grams per deciliter (g/dL), [Hb g/dL]at 48=blood hemoglobin concentration 48 hours after skin closure, and RBCUduring48=number of red blood cell units (RBCU) substituted during and after prostatectomy until 48 hours after skin closure.|48 hours post surgery|FAS||g/dL||Standard Deviation|Mean
724691|NCT00346268|Secondary|Time to Last Administration of Morphine|Time from last surgical stitch after prostatectomy to last administration of morphine (PCA and/or bolus).|baseline (end of surgery) to 48 hours post surgery|FAS; Number of participants analyzed (N)=participants with evaluable data||hours||Full Range|Median
724692|NCT00346268|Secondary|Cumulative Amount of Morphine Administered in the First 48 Hours Following Surgery|Total cumulative amount of morphine administered (PCA and/or bolus) in the first 48 hours after the application of the last surgical stitch after prostatectomy.|48 hours post surgery|FAS||mL||Standard Deviation|Mean
724693|NCT00346268|Primary|Cumulative Amount of Morphine Administered in the First 24 Hours Following Surgery|Total cumulative amount of morphine administered (PCA and/or bolus) in the first 24 hours after the application of the last surgical stitch after prostatectomy.|24 hours post surgery|Full Analysis Set Population (FAS): participants who were randomized to treatment||mL||Standard Deviation|Mean
724694|NCT00346333|Secondary|Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity|Annual change in number of letters read.|assessed at each of 4 annual visits after baseline|This was an intention to treat analysis and included all reliable, non-missing values. The unit of analysis was the eye.Each patient contributed 2,1, or 0 eyes with non-missing data.||Change in letters read per year||Standard Error|Mean
724695|NCT00346333|Secondary|Annual Change in 30 Hertz(Hz)Electroretinogram(ERG )Amplitude in Natural Log (ln) Microvolts/yr Over a 4 Year Period.|Computer averaged 30 Hz ERG amplitudes in microvolts for those with initial amplitudes of >= 0.68 microvolts. Presented on the ln scale.|assessed at each of 4 annual visits after baseline|This was an intention to treat analysis;analyses of 30 Hz ERG data included those who had an initial amplitude of 0.68 microvolts or greater in at least 1 eye and data were censored when values declined to less than 0.34 microvolts. The unit of analysis was the eye.Each patient contributed 2,1,or 0 eyes with non-missing data.||ln (microvolts)/year||Standard Error|Mean
724696|NCT00346333|Secondary|Total Field Change Assessed by the Combined 30-2 and 60-4 Programs of the Humphrey Field Analyzer.|Sum of visual field sensitivity readings in dB to a size V target obtained with the 30-2 and 60-4 programs of the Humphrey Field Analyzer combined for those patients on whom both measures were available.|assessed at each of 4 annual visits after baseline|This was an intention to treat analysis. A total field was calculated for each eye using the 30-2 and 60-4 conditions after applying the eligibility criteria for each component. Total field for a given eye was not calculated if either was missing. The unit of analysis was the eye.Each patient contributed 2, 1, or 0 eyes with non-missing data.||annual change in dB vf sensitivity||Standard Error|Mean
724697|NCT00346333|Secondary|Mid-peripheral Field Change Assessed With the 60-4 Program of the Humphrey Field Analyzer.|Sum of visual field sensitivity readings in dB to a size V target from the 30 degree meridian to the 60 degree meridian in each direction of the visual field. The value presented represents annual change in dB over 4 years.|assessed at each of 4 annual visits after baseline|This was an intention to treat analysis;lower sample sizes for this endpoint reflect instances where test results were not available for this outcome variable.The ability to perform this test was not a criterion for study entry.Eyes with an initial score ≥ 10 were included. Values were set to zero for all visits after an initial value of zero.||annual change in dB vf sensitivity||Standard Error|Mean
724698|NCT00346333|Primary|Central Visual Field (vf) Change Assessed Using the 30-2 Program of the Humphrey Field Analyzer (HFA).|Sum of visual field sensitivity readings in decibel(dB) to a size V target out to the 30 degree meridian in each direction of the visual field. The value presented represents annual change in dB over 4 years.|assessed at each of 4 annual visits after baseline|Intention to treat analysis;sample of 215 patients with all 4 years of followup and reliable, non missing data at all 4 years was analyzed. Eyes with an initial 30-2 total point score >= 250 dB were included.The eye was the unit of analysis. Each patient contributed 2,1, or 0 eyes with non-missing data.||annual change in db vf sensitivity||Standard Error|Mean
724699|NCT00346398|Secondary|Time to First Onset of Asthma|Time to first onset of asthma is the time from the day a participant is randomized and initiates study treatment to the diagnosis of the first of three episodes of asthma. Asthma is defined as three distinct episodes of wheeze after the first year of life, each of which lasts 3 or more consecutive days and occurs in a clinical setting where asthma is likely and other likely conditions have been excluded. Episodes must be separated by at least 7 days without wheeze.|From Treatment Initiation to Month 36 Status Post Treatment Completion|Intent-to-treat minus one participant in placebo group who had a sibling in trial||Months||Standard Error|Mean
724700|NCT00346398|Secondary|Number of Participants With Current Asthma at Month 36 Status Post Treatment Completion|Participants who currently have asthma three years after end of treatment. Asthma is defined as three distinct episodes of wheeze after the first year of life, each of which lasts 3 or more consecutive days and occurs in a clinical setting where asthma is likely and other likely conditions have been excluded. Episodes must be separated by at least 7 days without wheeze. Current asthma is defined as a diagnosis of asthma and at least one episode of wheeze lasting 3 or more consecutive days in the past 12 months.|Three years (36 months) after Treatment Completion|Intent-to-treat minus one participant in placebo group who had a sibling in trial||participants|||Number
724701|NCT00346398|Primary|Number of Participants With Allergic Sensitization at Month 36 Status Post Treatment Completion|"Allergic sensitization is defined as a positive serum allergen specific Immunoglobulin E (IgE) CAP test[1] or a positive allergy skin prick test[2]. Not experiencing allergic sensitization is the better outcome for this measure.
A positive serum allergen specific IgE CAP (ImmunoCAP) test result is defined by a result >= 0.35 kU/L. Higher scores indicate greater allergic sensitization.
A positive skin prick test is defined as a wheal diameter that is 3 mm larger than that produced by a negative control. Higher wheal sizes indicate greater allergic reaction or sensitization."|Three years (36 months) after Treatment Completion|Intent-to-treat minus one participant in placebo group who had a sibling in trial||participants|||Number
724702|NCT00346476|Primary|Number of Participants With HIV Infection||At Year 5|||participants|||Number
724703|NCT00346476|Secondary|Number of Recurrent Cases of TB Attributable to Endogenous Reactivation Versus Exogenous Re-infection in Both HIV Infected and Uninfected Participants||At Year 5||||||
724704|NCT00346476|Secondary|Diversity of TB Strains Among HIV Infected Participants Receiving HAART, HIV Infected Participants Not Receiving HAART, and HIV Uninfected Participants||Year 1 to Year 5||||||
724705|NCT00346476|Secondary|Changes in the Clustering and Transmission of TB Among HIV Infected and Uninfected Participants After the Introduction of HAART||Year 1 to Year 5||||||
724706|NCT00346476|Secondary|Changes in Clustering and Transmission of TB Among HIV Infected and Uninfected Participants||Year 1 to Year 5||||||
724707|NCT00346476|Primary|Number of Participants With Microbiologically Confirmed Tuberculosis Infection||At Year 5|||participants|||Number
724708|NCT00346632|Secondary|Disease Response|"Disease response (i.e., complete or partial remission) based on standard criteria:
Cheson BD, Bennett JM, Kopecky KJ, Buchner T, Willman CL, Estey EH, et al. Revised recommendations of the International Working Group for diagnosis, standardization of response criteria, treatment outcomes, and reporting standards for therapeutic trials in acute myeloid leukemia. J Clin Oncol. 2003 Dec 15;21(24):4642-4649.
Cheson BD, Bennett JM, Kantarjian H, Pinto A, Schiffer CA, Nimer SD, et al. Report of an international working group to standardize response criteria for myelodysplastic syndromes. Blood. 2000 Dec 1;96(12):3671-3674.
VHA Pharmacy Benefits Management Strategic Healthcare Group and the Medical Advisory Panel. Criteria for use of Imatinib Mesylate (Gleevec®) [updated March 2002; cited 2005 Nov 16]. Available from: http://www.pbm.va.gov/archive/imatinibcriteria.pdf"|Day 14 (Arm A) or Day 28 (Arm B) for all cycles|||number of responders|||Number
724709|NCT00346632|Secondary|Accumulation Ratio (AUC 0-tau Day 14 or 28 / AUC 0-tau Day 1)||Day 1 and either Day 14 or Day 28 of Cycle 1|||Ratio of hr*ng/mL||Standard Deviation|Mean
724714|NCT00346632|Primary|Safety of KW-2449 - Number of Participants With Treatment-related Adverse Events (TEAEs) as Assessed by NCI-CTCAE v3.0|In addition to the number of TEAEs, the number of serious TEAEs, the number of related TEAEs, the number of Grade 3-4 TEAEs, and the number of subjects who died or discontinued due to TEAEs were also assessed. The maximally tolerated dose (MTD) was also to be determined, but it was not actually reached in either arm.|Baseline up to Cycle 2, Day 1|||participants|||Number
724715|NCT00346697|Secondary|Change in Collagen Epinephrine From Baseline in the LOVAZA Group Compared to the Placebo Group.||8 weeks|Analysis done on all participants with available data||seconds||Inter-Quartile Range|Median
724716|NCT00346697|Secondary|Change in Collagen ADP From Baseline in the LOVAZA Group Compared to the Placebo Group.||8 weeks|Analysis done on all participants with available data||seconds||Inter-Quartile Range|Median
724717|NCT00346697|Secondary|Change in P1NP Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.||8 weeks|Analysis done on all participants with available data||mcg/L||Inter-Quartile Range|Median
724718|NCT00346697|Secondary|Change in CTX Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.||8 weeks|Analysis done on all participants with available data||ng/mL||Inter-Quartile Range|Median
724719|NCT00346697|Secondary|Change in sTNFR2 Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.||8 weeks|Analysis done on all participants with available data||pg/mL||Inter-Quartile Range|Median
724720|NCT00346697|Secondary|Change in sTNFR1 Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.||8 weeks|Analysis done on all participants with available data||pg/mL||Inter-Quartile Range|Median
724721|NCT00346697|Secondary|Change in TNF-a Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.||8 weeks|Analysis done on all participants with available data||pg/mL||Inter-Quartile Range|Median
724722|NCT00346697|Secondary|Change in IL-6 Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.||8 weeks|Analysis done on all participants with available data||pg/mL||Inter-Quartile Range|Median
724723|NCT00346697|Secondary|Change in hsCRP Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.||8 weeks|Analysis done on all participants with available data||ng/ml||Inter-Quartile Range|Median
724724|NCT00346697|Secondary|Change in CD4+ T-cell Counts From Baseline in the LOVAZA Group Compared to the Placebo Group||8 weeks|Analysis done on all participants with available data||cells/cc||Inter-Quartile Range|Median
724725|NCT00346697|Secondary|Change in HOMA-IR From Baseline in the LOVAZA Group Compared to the Placebo Group||8 weeks|Analysis done on all participants with available data||units on a scale||Inter-Quartile Range|Median
724726|NCT00346697|Secondary|Change in HDL Cholesterol Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group||8 weeks|||mg/dl||Inter-Quartile Range|Median
724727|NCT00346697|Secondary|Change in Non-HDL Cholesterol Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group||8 weeks|||mg/dl||Inter-Quartile Range|Median
724728|NCT00346697|Secondary|Change in Total Cholesterol Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group||8 weeks|||mg/dl||Inter-Quartile Range|Median
724729|NCT00346697|Primary|Change in Triglyceride Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.||8 weeks|||mg/dl||Inter-Quartile Range|Median
724730|NCT00346905|Primary|Clinically Significant Reduction of PPI Usage at 12, 24, and 36 Month Follow-ups Compared to Baseline in Both Singly Treated and Retreated Patients.|Clinically significant reduction of PPI usage is defined as either elimination of medication use or reduction in dosage of ≥50% as compared to baseline. The criterion for success is defined as more than half of patients demonstrating this degree of medication reduction.|3 years either baseline to 12m, baseline to 24m, baseline to 36m|Overall Number of Participants Analyzed (16) will differ at 12m, 24m, and 36m intervals due to patients who were available at the given follow-up interval.||% of Participants|||Number
724731|NCT00338741|Secondary|Fetal Death/Stillbirth|Fetal death/stillbirth|Up to 10 months|||Participants|||Number
724732|NCT00338741|Primary|Spontaneous Abortion|Number of participants having spontaneous abortion|Up to 9 months|Population includes all subjects for whom data is available||Participants|||Number
724733|NCT00338806|Secondary|Treatment Credibility Scale|Treatment Credibility Questionnaire. Participant and parent’s expectancy about the perceived benefit of treatment will be assessed following the first intervention session after the treatment rationale is given. Adolescents were asked to rate how logical the treatment seemed to them, how confident they were that it would be successful, and how confident they would be in recommending the treatment to a friend. A 0- to 2-point rating scale (0 = none, 1 = some, 2 = a lot) was used (range of possible overall score 0-6, higher score indicating higher treatment credibility)|Measured at Week 1|An ECM participant did not fill out her form||units on a scale||Standard Deviation|Mean
724734|NCT00338806|Secondary|Social Rhythm Metric Short Form|The Social Rhythm Metric Short Form (SRM-Short Form) measures habitual time at which 5 daily events occur in a person’s life over a one-week interval: what time the adolescent gets out of bed, makes first contact with another person, starts school, has dinner, and goes to bed.|Measured at Week 12 and Months 6, 12, and 18 post-treatment|Participants were not filling out form (it required documentation during the week) and reconstructing it in the meetings with the clinician proved to be too time consuming. Measure was withdrawn from the assessment battery|||||
724735|NCT00338806|Secondary|Social Adjustment Scale - Self Report for Adolescents|(SAS-SR) for adolescents, a self-report instrument with 23 questions that fall into 4 major categories: school, friends, family, and dating. Patients rate themselves for the past 2 weeks and they can receive either a total score or a domain specific score. The total score is used here. Each item is scored 1-5, the total score is the average of the scores on each item, possible range of scores 1-5, higher scores indicating worse functioning.|12 months and 18 months|At the 12 and 18 months time point no participant was willing to be assessed on this secondary outcome measure (had limited time for these assessment visits)|||||
724736|NCT00338806|Secondary|Social Adjustment Scale - Self Report for Adolescents|(SAS-SR) for adolescents, a self-report instrument with 23 questions that fall into 4 major categories: school, friends, family, and dating. Patients rate themselves for the past 2 weeks and they can receive either a total score or a domain specific score. The total score is used here. Each item is scored 1-5, the total score is the average of the scores on each item, possible range of scores 1-5, higher scores indicating worse functioning.|Measured at Week 12|||units on a scale||Standard Deviation|Mean
724737|NCT00338806|Secondary|Patient Health Questionnaire|The PHQ-9 is a depression screen, administered to the adolescents parents in this study. The PHQ-9 scores each of the 9 DSM-IV criteria as “0” (not at all) to “3” (nearly every day). Scores can range from 0-27, with higher score indicating higher depression levels.|Measured at Week 1|||units on a scale||Standard Deviation|Mean
724738|NCT00338806|Secondary|Mood Disorder Questionnaire|A self-report inventory for the participant' parent that screens for history of a manic or hypomanic syndrome by including 13 yes/no items. A score >7 indicate possible history of mania/hypomania (coded as 1), <7 indicates potential absence of mania/hypomania (coded as 0)|Week 1|This measure reflects parental mood.expressed as number of participants whose parent with BDI or BDII endorsed > 7(1)||participants|||Number
724739|NCT00338806|Secondary|Family History Screen|A clinician-administered instrument to the adolescent' parent, designed to screen for mood, anxiety, and other disorders in parent’s first-degree relatives (parents, spouse).|Measured at Week 1 (baseline)|||participants|||Number
724740|NCT00338806|Secondary|Family Assessment Device|The General Functioning scale, that assesses the overall health/pathology of the family, is used for the study. The 12 item scores are averaged to calculate the total score, which ranges from 1-4, with higher scores reflecting worse functioning|Measured at Week 12|||units on a scale||Standard Deviation|Mean
724741|NCT00338806|Secondary|Emotion Regulation Questionnaire|"A self report 10-item scale designed to measure respondents’ tendency to regulate their emotions in two ways: (1) Cognitive Reappraisal and (2) Expressive Suppression. Respondents answer each item on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree).Items 1, 3, 5, 7, 8, 10 make up the Cognitive Reappraisal facet (score is averaged, i.e., the score lies between 1 and 7), higher score indicates higher Cognitive reappraisal).
Items 2, 4, 6, 9 make up the Expressive Suppression facet (score is averaged, i.e., the score lies between 1 and 7, higher score indicates higher Expressive Suppression)."|12 months and 18 months|At the 12 and 18 months time point no participant was willing to be assessed on this secondary outcome measure (had limited time for these assessment visits)|||||
724742|NCT00338806|Secondary|Emotion Regulation Questionnaire|"A self-report10-item scale designed to measure respondents’ tendency to regulate their emotions in two ways: (1) Cognitive Reappraisal and (2) Expressive Suppression. Respondents answer each item on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree).Items 1, 3, 5, 7, 8, 10 make up the Cognitive Reappraisal facet (score is averaged, i.e., the score lies between 1 and 7), higher score indicates higher Cognitive reappraisal).
Items 2, 4, 6, 9 make up the Expressive Suppression facet (score is averaged, i.e., the score lies between 1 and 7, higher score indicates higher Expressive Suppression)."|6 months|||units on a scale||Standard Deviation|Mean
724743|NCT00338806|Secondary|Emotion Regulation Questionnaire|"A self report 10-item scale designed to measure respondents’ tendency to regulate their emotions in two ways: (1) Cognitive Reappraisal and (2) Expressive Suppression. Respondents answer each item on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree).Items 1, 3, 5, 7, 8, 10 make up the Cognitive Reappraisal facet (score is averaged, i.e., the score lies between 1 and 7), higher score indicates higher Cognitive reappraisal).
Items 2, 4, 6, 9 make up the Expressive Suppression facet (score is averaged, i.e., the score lies between 1 and 7, higher score indicates higher Expressive Suppression)."|Measured at Week 12|Data were not collected for 6 and 12 month time points||units on a scale||Standard Deviation|Mean
724744|NCT00338806|Secondary|Attitudes Toward Treatment Questionnaire|A 4 item measure to evaluate attitudes towards: length of treatment, helpfulness of therapist, effects of participating in research, and additional services desired. Each item had 3 response options: 1.positive (or longer treatment) 2.neutral (or length just right) 3. negative (or shorter treatment). Scores are summed with potential range from 4-12. Lower number indicates more positive attitude|Measured at Week 12|||units on a scale||Standard Deviation|Mean
724745|NCT00338806|Primary|Young Mania Rating Scale (YMRS)|An 11-item clinician-rated instrument for assessing the severity of manic episodes. 7 of the items are rated on a scale 0-4 and 4 are rated from 0-8. Total scores can range from 0-60, with higher scores indicating greater severity of symptoms.|18 months|At the 18 month time point 1 participant was available /willing to be assessed||units on a scale||Standard Deviation|Mean
724746|NCT00338806|Primary|Young Mania Rating Scale (YMRS)|An 11-item clinician-rated instrument for assessing the severity of manic episodes. 7 of the items are rated on a scale 0-4 and 4 are rated from 0-8. Total scores can range from 0-60, with higher scores indicating greater severity of symptoms.|12 months|At the 12 month time point 1 participant was available /willing to be assessed||units on a scale||Standard Deviation|Mean
724747|NCT00338806|Primary|Young Mania Rating Scale (YMRS)|An 11-item clinician-rated instrument for assessing the severity of manic episodes. 7 of the items are rated on a scale 0-4 and 4 are rated from 0-8. Total scores can range from 0-60, with higher scores indicating greater severity of symptoms.|6 months|||units on a scale||Standard Deviation|Mean
724748|NCT00338806|Primary|Young Mania Rating Scale (YMRS)|An 11-item clinician-rated instrument for assessing the severity of manic episodes. 7 of the items are rated on a scale 0-4 and 4 are rated from 0-8. Total scores can range from 0-60, with higher scores indicating greater severity of symptoms.|Week 12|||units on a scale||Standard Deviation|Mean
724749|NCT00338806|Primary|Children's Global Assessment Scale (C-GAS)|C-GAS is a clinician-rated measure of overall severity of disturbance. A single assigned score ranging from 0 (most severe level of impairment) to 100 (absence of impairment) represents level of functional impairment.|18 months|At the 18 month time point 1 participant was available /willing to be assessed||units on a scale||Standard Deviation|Mean
724750|NCT00338806|Primary|Children's Global Assessment Scale (C-GAS)|C-GAS is a clinician-rated measure of overall severity of disturbance. A single assigned score ranging from 0 (most severe level of impairment) to 100 (absence of impairment) represents level of functional impairment.|12 months|At the 12 month time point 1 participant was available /willing to be assessed||units on a scale||Standard Deviation|Mean
724751|NCT00338806|Primary|Children's Global Assessment Scale (C-GAS)|C-GAS is a clinician-rated measure of overall severity of disturbance. A single assigned score ranging from 0 (most severe level of impairment) to 100 (absence of impairment) represents level of functional impairment.|6 months|||units on a scale||Standard Deviation|Mean
724752|NCT00338806|Primary|Children's Global Assessment Scale (C-GAS)|C-GAS is a clinician-rated measure of overall severity of disturbance. A single assigned score ranging from 0 (most severe level of impairment) to 100 (absence of impairment) represents level of functional impairment.|Week 12|||units on a scale||Standard Deviation|Mean
724753|NCT00338806|Primary|Children's Depression Rating Scale-Revised (CDRS-R)|CDRS-R Total score measures the presence and severity of depression in children/adolescents. The scale has 17 items scored on a 1-to-5 (3 items)- or 1-to-7 (14 items)-point scale. Total scores range from 17 to 113. Lower scores indicate lower depression, scores > 41 indicate mild-moderate depression.|18 months|At the 18 month time point 1 participant was available /willing to be assessed||units on a scale||Standard Deviation|Mean
724754|NCT00338806|Primary|Children's Depression Rating Scale-Revised (CDRS-R)|CDRS-R Total score measures the presence and severity of depression in children/adolescents. The scale has 17 items scored on a 1-to-5 (3 items)- or 1-to-7 (14 items)-point scale. Total scores range from 17 to 113. Lower scores indicate lower depression, scores > 41 indicate mild-moderate depression.|12 months|At the 12 month time point 1 participant was available /willing to be assessed||units on a scale||Standard Deviation|Mean
724755|NCT00338806|Primary|Children's Depression Rating Scale-Revised (CDRS-R)|CDRS-R Total score measures the presence and severity of depression in children/adolescents. The scale has 17 items scored on a 1-to-5 (3 items)- or 1-to-7 (14 items)-point scale. Total scores range from 17 to 113. Lower scores indicate lower depression, scores > 41 indicate mild-moderate depression.|6 months|||units on a scale||Standard Deviation|Mean
724756|NCT00338806|Primary|Children's Depression Rating Scale-Revised (CDRS-R)|CDRS-R Total score measures the presence and severity of depression in children/adolescents. The scale has 17 items scored on a 1-to-5 (3 items)- or 1-to-7 (14 items)-point scale. Total scores range from 17 to 113. Lower scores indicate lower depression, scores > 41 indicate mild-moderate depression.|Week 12|||units on a scale||Standard Deviation|Mean
724757|NCT00338806|Primary|K SADS-Present Version (KSADS-P)|A semi-structured interview designed to assess present episode and episode since last assessment of psychiatric illness according to DSM-IV criteria. The mood, anxiety, substance use and disruptive disorders sections were administered.|18 months|At the 18 month follow up point only 1 participant was available and willing be assessed.||participants|||Number
724758|NCT00338806|Primary|K SADS-Present Version (KSADS-P)|A semi-structured interview designed to assess present episode and episode since last assessment of psychiatric illness according to DSM-IV criteria. The mood, anxiety, substance use and disruptive disorders sections were administered.|12 months|At the 12 month follow up timepoint only 1 participant was available and willing to be assessed.||participants|||Number
724759|NCT00338806|Primary|K SADS-Present Version (KSADS-P)|A semi-structured interview designed to assess present episode and episode since last assessment of psychiatric illness according to DSM-IV criteria. The mood, anxiety, substance use and disruptive disorders sections were administered.|6 months|||participants|||Number
724760|NCT00338806|Primary|K SADS-Present Version (KSADS-P)|A semi-structured interview designed to assess present episode of psychiatric illness according to DSM-IV criteria. The mood, anxiety, substance use and disruptive disorders sections were administered.|12 weeks|||participants|||Number
724761|NCT00338884|Secondary|Cancer Related Symptoms, Well-Being, and Concerns|FACT-Advanced Kidney Cancer Symptom Index (FKSI) Questionnaire: subscale designed to be a stand-alone instrument to measure symptoms and quality of life in patients with advanced kidney cancer. Contains 15 questions. Each question was answered on a 5-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Total FKSI score = sum score of the 15 item scores; total range: 0 - 60; 0 (most severe symptoms and concerns) to 60 (no symptoms or concerns). End of treatment assessment was for subjects who completed the study only.|Baseline (Day 1, Week 1), Day 1 of Weeks 3, 5, 7, 9, 11, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, Week 53 (End of Treatment)|Safety population. Number of Participants analyzed = number of subjects evaluable for the FACIT-Fatigue analysis. n=number of subjects with scores at each time point.||scores on a scale||Standard Deviation|Mean
724762|NCT00338884|Secondary|Patient-Assessed Fatigue|Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Scale: Overall score from 13-question questionnaire (measures fatigue/asthenia for patients with chronic, life-threatening illnesses). For each question, patient rates condition for the past week on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). Total FACIT-Fatigue score = sum score of the 13 question scores; total range: 0 - 52; higher total score represents less fatigue. End of treatment assessment was for subjects who completed the study only.|Baseline (Day 1, Week 1), Day 1 of Weeks 3, 5, 7, 9, 11, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, Week 53 (End of Treatment)|Safety population. Number of Participants analyzed = number of subjects evaluable for the FACIT-Fatigue analysis. n=number of subjects with scores at each time point.||scores on a scale||Standard Deviation|Mean
724763|NCT00338884|Secondary|sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)|Median sVEGFR2 concentration at each time point divided by sVEGFR2 concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR or [SD > = 12 weeks] versus PD).|Baseline to Day 1 of Weeks 3 through 53|Safety population. Number of Participants analyzed = number of subjects with evaluable data and tumor response. n=number of subjects with evaluable data and tumor response at each specified time point. No subjects had PD following Week 33.||ratio||Full Range|Median
724764|NCT00338884|Secondary|sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)|Median sVEGFR2 concentration at each time point divided by sVEGFR2 concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR versus PD).|Baseline to Day 1 of Weeks 3 through 53|Safety population. Number of Participants analyzed = number of subjects with evaluable data and tumor response. n=number of subjects with evaluable data and tumor response at each specified time point. No subjects had PD following Week 33.||ratio||Full Range|Median
724765|NCT00338884|Secondary|sVEGFR2 Ratio to Baseline at Each Time Point|sVEGFR2 concentration at each time point divided by sVEGFR2 concentration at baseline (ratio to baseline).|Baseline to Day 1 of Weeks 3 through 53|Safety population. Number of Participants analyzed = number of subjects with evaluable data at baseline. n=number of subjects with evaluable data at each specified time point.||ratio||Standard Deviation|Mean
724766|NCT00338884|Secondary|sVEGFR2 at Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)|Summary statistics of sVEGFR2 at baseline by group (CR or PR or SD versus PD) are presented.|Baseline (Cycle 1, Day 1)|Safety population. n=number of subjects with levels of soluble protein biomarkers and tumor response at baseline.||pg/mL||Full Range|Median
724797|NCT00339040|Secondary|CD4 Count Over Time||Arm A week 0, 8, 12, 24, 28, 72, 96, 100 and 108; Arm B week 0, 8, 12, 24, 28, 72, 96, 100, 104, 108, 120, and 124.|Any participant who received at least one study vaccine/placebo and with non-missing CD4 counts.||cells/µL||95% Confidence Interval|Mean
724767|NCT00338884|Secondary|sVEGFR2 at Baseline Stratified by Tumor Response (CR or PR Versus PD)|Summary statistics of sVEGFR2 at baseline by group (CR or PR versus PD) are presented.|Baseline (Cycle 1, Day 1)|Safety population. n=number of subjects with levels of soluble protein biomarkers and tumor response at baseline.||pg/mL||Full Range|Median
724768|NCT00338884|Secondary|Soluble VEGF Receptor 2 (sVEGFR2) Concentration at Baseline||Baseline|Safety population. Number of Participants analyzed = number of subjects with evaluable data at baseline.||pg/mL||Standard Deviation|Mean
724769|NCT00338884|Secondary|VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)|Median VEGF concentration at each time point divided by VEGF concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR or [SD > = 12 weeks] versus PD).|Baseline to Day 1 of Weeks 3 through 53|Safety population. Number of Participants analyzed = number of subjects with evaluable data and tumor response. n=number of subjects with evaluable data and tumor response at each specified time point. No subjects had PD following Week 33.||ratio||Full Range|Median
724770|NCT00338884|Secondary|VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)|Median VEGF concentration at each time point divided by VEGF concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR versus PD).|Baseline to Day 1 of Weeks 3 through 53|Safety population. Number of Participants analyzed = number of subjects with evaluable data and tumor response. n=number of subjects with evaluable data and tumor response at each specified time point. No subjects had PD following Week 33.||ratio||Full Range|Median
724771|NCT00338884|Secondary|VEGF Ratio to Baseline at Each Time Point|VEGF concentration at each time point divided by VEGF concentration at baseline (ratio to baseline).|Baseline to Day 1 of Weeks 3 through 53|Safety population. Number of Participants analyzed = number of subjects with evaluable data at baseline. n=number of subjects with evaluable data at each specified time point.||ratio||Standard Deviation|Mean
724772|NCT00338884|Secondary|VEGF at Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)|Summary statistics of VEGF at baseline by group (CR or PR or SD versus PD) are presented.|Baseline (Cycle 1, Day 1)|Safety population. n=number of subjects with levels of soluble protein biomarkers and tumor response at baseline.||pg/mL||Full Range|Median
724773|NCT00338884|Secondary|VEGF at Baseline Stratified by Tumor Response (CR or PR Versus PD)|Summary statistics of VEGF at baseline by group (CR or PR versus PD) are presented.|Baseline (Cycle 1, Day 1)|Safety population. n=number of subjects with levels of soluble protein biomarkers and tumor response at baseline.||pg/mL||Full Range|Median
724774|NCT00338884|Secondary|Vascular Endothelial Growth Factor (VEGF) Concentration at Baseline||Baseline|Safety population. Number of Participants analyzed = number of subjects with evaluable data at baseline.||picograms (pg)/mL||Standard Deviation|Mean
724775|NCT00338884|Secondary|Ctrough Correlated With Serious Adverse Events (SAEs)|Serious adverse event defined as any untoward medical occurrence at any dose that: Results in death; Is life-threatening (immediate risk of death); Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent or significant disability/incapacity; Results in congenital anomaly/birth defect.|Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53|Ctrough correlation analyses with SAEs were not performed due to low frequency of individual SAEs.|||||
724776|NCT00338884|Secondary|Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662)|Summary statistics of ctrough at each time point by group (CR or PR or SD versus PD) are presented.|Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53|PK. Number of Participants analyzed = number of subjects with evaluable PK data and tumor response at baseline. n=number of subjects with evaluable PK data and tumor response at each specified time point. No subjects had PD following Week 33.||ng/mL||Full Range|Median
724777|NCT00338884|Secondary|Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662)|Summary statistics of ctrough at each time point by group (CR or PR versus PD) are presented.|Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53|PK. Number of Participants analyzed = number of subjects with evaluable PK data and tumor response at baseline. n=number of subjects with evaluable PK data and tumor response at each specified time point. No subjects had PD following Week 33.||ng/mL||Full Range|Median
724778|NCT00338884|Secondary|Ctrough of Total Drug (Sunitinib + SU-012662)|Ctrough = the concentration prior to study drug administration.|Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53|PK. Number of Participants analyzed = number of subjects evaluable for PK analysis. n=number of subjects evaluable at each time point.||ng/mL||Standard Deviation|Mean
724779|NCT00338884|Secondary|Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite)|Summary statistics of ctrough at each time point by group (CR or PR or SD versus PD) are presented.|Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53|PK. Number of Participants analyzed = number of subjects with evaluable PK data and tumor response at baseline. n=number of subjects with evaluable PK data and tumor response at each specified time point. No subjects had PD following Week 33.||ng/mL||Full Range|Median
724780|NCT00338884|Secondary|Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite)|Summary statistics of ctrough at each time point by group (CR or PR versus PD) are presented.|Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53|PK. Number of Participants analyzed = number of subjects with evaluable PK data and tumor response at baseline. n=number of subjects with evaluable PK data and tumor response at each specified time point. No subjects had PD following Week 33.||ng/mL||Full Range|Median
724781|NCT00338884|Secondary|Ctrough of SU-012662 (Sunitinib's Metabolite)|Ctrough = the concentration prior to study drug administration.|Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53|PK. Number of Participants analyzed = number of subjects evaluable for PK analysis. n=number of subjects evaluable at each time point.||ng/mL||Standard Deviation|Mean
724782|NCT00338884|Secondary|Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib|Summary statistics of ctrough at each time point by group (CR or PR or SD versus PD) are presented.|Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53|PK. Number of Participants analyzed = number of subjects with evaluable PK data and tumor response at baseline. n=number of subjects with evaluable PK data and tumor response at each specified time point. No subjects had PD following Week 33.||ng/mL||Full Range|Median
724783|NCT00338884|Secondary|Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib|Summary statistics of ctrough at each time point by group (CR or PR versus PD) are presented.|Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53|PK. Number of Participants analyzed = number of subjects with evaluable PK data and tumor response at baseline. n=number of subjects with evaluable PK data and tumor response at each specified time point. No subjects had PD following Week 33.||ng/mL||Full Range|Median
724784|NCT00338884|Secondary|Trough Plasma Concentrations (Ctrough) of Sunitinib|Ctrough = the concentration prior to study drug administration.|Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53|Pharmacokinetic (PK) population = treated and had least 1 PK sample taken. Number of Participants analyzed = number of subjects evaluable for PK analysis. n=number of subjects evaluable at each time point.||nanograms (ng)/milliliter (mL)||Standard Deviation|Mean
724785|NCT00338884|Secondary|1-Year Survival|One year survival rate defined as the probability that a subject was alive 1 year after the date of first study treatment.|From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter up until 1 year|Safety population. Number of participants analyzed = number of subjects evaluable for 1 year survival analysis.||percent chance of survival||95% Confidence Interval|Median
724786|NCT00338884|Secondary|Progression-Free Survival (PFS)|Time from start of study medication to first documentation of objective tumor progression or to death due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. PFS (in months) was calculated as (first event date minus first dose date +1)/7.|From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter or death|Safety population. Number of participants analyzed = number of subjects evaluable for PFS analysis.||months||95% Confidence Interval|Median
724787|NCT00338884|Secondary|Time to Tumor Progression (TTP)|Time from date of first dose of study medication to first documentation of objective tumor progression. The 50% quartile point estimate is provided. The criteria for tumor progression was according to RECIST.|From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter|Safety population. 64 subjects were censored. Number of participants analyzed = number of subjects evaluable for tumor progression analysis.||months||95% Confidence Interval|Median
724788|NCT00338884|Secondary|Duration of Response (DR)|Time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression or to death due to to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. DR was calculated as [the end date for DR minus first CR or PR that was subsequently confirmed +1]/7.|From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter or death due to any cause|Safety population subgroup of subjects with a confirmed objective tumor response. DR was only calculated for the subgroup of subjects with a confirmed objective response.||months||95% Confidence Interval|Mean
724789|NCT00338884|Primary|Number of Subjects With Overall Confirmed Objective Response (OR)|OR = subjects with confirmed complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) persisting > = 4 weeks after initial documentation of response. A CR was defined as the disappearance of all target lesions. A PR was defined as a ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter|Safety Population=all enrolled subjects who received at least 1 dose of sunitinib. For OR rate analysis, subjects who did not have a baseline assessment of disease were excluded from the analysis. Number of participants analyzed = number of subjects evaluable for OR analysis.||participants|||Number
724790|NCT00338962|Primary|Mean Number of Side Effects|Differences in mean number of side effects reported for each group. Side effects and common adverse symptoms were evaluated by the research staff weekly, using a modified version of the ystematic Assessment for Treatment Emergent Events. The symptoms that are known to be associated with treatment with desipramine, paroxetine, and naltrexone were specifically screened or on a weekly basis. The symptoms were then clustered into the following categories: gastrointestinal, emotional, cold and flu symptoms, skin, sexual, neurological, and cardiac.|12 weeks|||side effects||Standard Error|Mean
724791|NCT00338962|Primary|Hamilton Depression Rating Scale (HAM-D)|The HAM-D ranges from 0 (Normal) to >23 (Very Severe Depression)|beginning of treatment (week 1), and end of treatment (13 weeks)|||units on a scale||Standard Error|Mean
724792|NCT00338962|Primary|Clinician-Administered PTSD Scale (CAPS)|"The CAPS is the gold standard in PTSD assessment. The CAPS-5 is a 30-item structured interview that can be used to:
Make current (past month) diagnosis of PTSD Make lifetime diagnosis of PTSD Assess PTSD symptoms over the past week Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). A higher score is associated with higher severity of PTSD. The score is interpreted as follows: 0-19=Asymptomatic/few symptoms 20-39=Sub-threshold/mild PTSD 40-59=Threshold PTSD/moderate 60-79=Severe PTSD >80=Extreme PTSD"|beginning of treatment (week 1), and end of treatment (13 weeks)|||units on a scale||Standard Error|Mean
724793|NCT00338962|Primary|Mean Self-report Weekly Craving Via Obsessive Compulsive Drinking Scale (OCDS)|The OCDS is a 14-item (rated 0-4), self-administered questionnaire for characterizing and quantifying the obsessive and compulsive cognitive aspects of craving and heavy (alcoholic) drinking, such as drinking-related thought, urges to drink, and the ability to resist those thoughts and urges. A higher total score indicates higher craving and ranges from 0-48.|beginning of treatment (week 1), and end of treatment (13 weeks)|||units on a scale||Standard Error|Mean
724794|NCT00338988|Primary|Number of Participants With Objective Response|Objective Response = Complete Response + Partial Response. Response evaluated using modification of new international criteria proposed by RECIST [changes in only largest diameter (unidimensional measurement) of tumor lesions used in the RECIST criteria]. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|Baseline with restaging every 3 cycles (cycle=21 days)|Analysis was per protocol. One participant was found ineligible and received no treatment.||participants|||Number
724795|NCT00339040|Secondary|HIV-1 Viral Load (Ribonucleic Acid [RNA] Copies/ml) Over Time||Arm A week 0, 8, 12, 24, 28, 72, 96, 100 and 108; Arm B week 0, 8, 12, 24, 28, 72, 96, 100, 104, 108, 120, and 124.|Any participant who received at least one study vaccine/placebo and with non-missing HIV-1 viral load.||Log10(copies/mL)||95% Confidence Interval|Log Mean
724798|NCT00339040|Primary|Serum Anti-HPV Antibody Titers (cLIA)|Geometric means of Type-specific Serum anti-HPV antibody titers (cLIA)|Arm A week 0, 28, 72, 96, 97, 100; Arm B week 0, 28, 72, 96, 97, 100, 124.|The type-specific results are reported for participants remaining after exclusion of those with protocol violations, unevaluable specimens, or the presence of type-specific sero-positive antibody at baseline as well as any participants with any missing values at any time points.||milli-Merck units [mMU]/mL||95% Confidence Interval|Geometric Mean
724799|NCT00339040|Primary|Percent of Participants With Human Papillomavirus (HPV) Type-Specific Seroconversion|Serum anti-HPV 6, 11, 16, and 18 antibody was measured using a competitive Luminex immunoassay (cLIA; reported in milli-Merck Units [mMU]/mL). Sero-positivity was defined as an anti-HPV titer ≥20, 16, 20, and 24 mMU/mL, for HPV types 6, 11, 16, and 18, respectively.|At week 28 after beginning the vaccination series|The type-specific results are reported for participants remaining after exclusion of those with protocol violations, unevaluable specimens, or the presence of type-specific sero-positive antibody at baseline.||percent of participants||95% Confidence Interval|Number
724800|NCT00339040|Primary|Percent of Participants Developing Grade 3 or 4 Adverse Events (AEs) Attributed to Study Treatment|"Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (December 2004). All grade 3 and higher signs, symptoms, and laboratory toxicities attributed to study treatment were included. The relationship between the Adverse Events and the vaccination were evaluated by study team and assigned to, for example, Treatment related, Non-treatment related, Baseline, Possibly treatment related."|Within 14 days of first three doses of vaccination|Any participant who received at least one study vaccine/placebo were included in the safety analysis||percent of participants||95% Confidence Interval|Number
724801|NCT00339040|Primary|Percent of Participants Developing Grade 3 or 4 Adverse Events (AEs)|"Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (December 2004). The grades used are: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening. All grade 3 and higher signs, symptoms, and laboratory toxicities were included."|Within 14 days of first three doses of vaccination|Any participant who received at least one study vaccine/placebo were included in the safety analysis.||percent of participants||95% Confidence Interval|Number
724802|NCT00339079|Secondary|Columbia Heightened Illness Concern - Obsessive-Compulsive Scale|The Columbia Heightened Illness Concern - Obsessive-Compulsive Scale was the name for an earlier version of the H-YBOCS-M. The H-YBOCS-M is an expanded version and has additional items not included in the Columbia Heightened Illness Concern OCS. We did not administer the CHIC-OCS to patients in this study.|Not measured||||||
724803|NCT00339079|Primary|25% Improvement on Both Whiteley Index and H-YBOCS-M|Whitley index is a self-report measure of hypochondriasis H-YBOCS-M is an independent evaluator structured assessment of hypochondriasis|Measured at Week 24|||Participants|||Count of Participants
724804|NCT00339144|Secondary|Number of Participants With Complete Response (CR) or Partial Response (PR)|Tumor response was defined as the number of participants whose best response was CR or PR as per Response Evaluation Criteria In Solid Tumors (RECIST) criteria. CR: disappearance of all target/non-target lesions; PR: >= 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|Within 4 weeks of first study drug administration, thereafter recorded every 4 or 8 weeks.|All treated participants with measurable disease at baseline and received at least one dose of the study drug (efficacy population).||participants|||Number
724805|NCT00339144|Secondary|Number of Participants With Sarcoma (Src) and Phosphorylated Src (pSRc) Protein Expression in Peripheral Blood Mononuclear Cells (PBMC)|Src and pSrc protein expression was planned to be evaluated in PBMC for establishing PK/PD relationship between Src/pSrc protein expression in PBMC and exposure of BMS-354825.|Plasma samples were collected on baseline (Day -1), 0 hour (pre-dose), 1 and 4 hours (post-dose) on Days 1, 14 and 28|All treated participants with adequate pharmacodynamic profiles. Participants could not be evaluated as the test was discontinued due to difficulty in appropriate measurements.||participants|||Number
724806|NCT00339144|Secondary|Mean Serum Concentration of Bone Alkaline Phosphatase (BAP) Biological Marker|BAP is a measure of bone metabolism. A decrease in BAP relative to the baseline indicates decrease in bone metabolism. Serum BAP was quantified with ELISA.|Serum samples were assessed on baseline (Day -1), and pre-dose on Days 14, 28|All treated participants with adequate PD profiles (PD population). The 'n' signifies those participants who received study drug and were evaluated for this measure (each group respectively).||U/L||Standard Deviation|Mean
724807|NCT00339144|Secondary|Mean Serum Concentration of Tartrate-resistant Acid Phosphatase Isoform 5b (TRACP-5b) Biological Marker|TRACP-5b is a measure of bone metabolism. A decrease in TRACP-5b relative to the baseline indicates decrease in bone metabolism. Serum TRACP-5b was quantified with enzyme-linked-immunosorbent serologic assay (ELISA).|Serum samples were assessed at baseline (Day -1) and on Days 14 and 28|All treated participants with adequate PD profiles (PD population). The 'n' signifies those participants who received study drug and were evaluated for this measure (each group respectively).||U/L||Standard Deviation|Mean
724808|NCT00339144|Secondary|Mean Urine Concentration of Deoxypyridinoline (Dpyr) Biological Marker|Urine levels of DPyr is a measure of bone resorption. A decrease in Dpyr relative to the baseline indicates decrease in bone metabolism. Mean urine concentration of Dpyr biological marker was determined using ELISA.|Urine samples were collected at baseline (Day -1) and 0 hour (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6 12 and 24 hours post dose on Days 14 and 28|All treated participants with adequate PD profiles (PD population). The 'n' signifies those participants who received study drug and were evaluated for this measure (each group respectively).||nanomol (nmol)/mL||Standard Deviation|Mean
724809|NCT00339144|Secondary|Mean Urine Concentration of Urinary N-telopeptide Type 1 Collagen (NTx) Biological Marker|Urine NTx is a measure of bone metabolism. A decrease in the marker relative to baseline indicates a decrease in bone metabolism. Mean urine concentration of NTx biological marker was determined using enzyme linked immuno-sorbent assay (ELISA).|Urine samples were collected at baseline (Day -1) and 0 hour (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 12 and 24 hours (post dose) on Days 14 and 28.|All treated participants with adequate pharmacodynamic (PD) profiles (PD population). The 'n' signifies those participants who received study drug and were evaluated for this measure (each group respectively).||nmol*bone collagen equivalent (BCE)/mmol||Standard Deviation|Mean
727504|NCT00376168|Secondary|Change From Baseline in Liver Volume|Calculated as percent change in liver volume from Baseline to 9 months|Baseline and 9 months|Intent to treat||percentage of change from baseline||Standard Deviation|Mean
724810|NCT00339144|Secondary|Tmax of the Metabolite BMS-582691|Tmax of the metabolite was obtained using plasma concentration versus time data of metabolite BMS-582691.|Blood samples were collected at 0 hour (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 12 and 24 hours (post dose) on Days 1, 14 and 28|All treated participants with adequate PK profiles (PK population). The 'n' signifies those participants who received study drug and were evaluated for this measure (each group respectively).||hours||Full Range|Median
724811|NCT00339144|Secondary|AUC (0-t) of Metabolite BMS-582691|AUC (0-t) was calculated using plasma concentration values of metabolite at time 0 to the time of the last measurable concentration (t).|Blood samples were collected at 0 hour (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 12 and 24 hours (post dose) on Days 1, 14 and 28|All treated participants with adequate PK profiles (PK population). The 'n' signifies those participants who received study drug and were evaluated for this measure (each group respectively).||ng*hr/mL||Full Range|Geometric Mean
724812|NCT00339144|Secondary|Cmax of Metabolite BMS-582691|Maximum plasma concentration was obtained from plasma concentration versus time data of metabolite (BMS-582691).|Blood samples were collected at 0 hour (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 12 and 24 hours (post dose) on Days 1, 14 and 28|All treated participants with adequate PK profiles (PK population). The 'n' signifies those participants who received study drug and were evaluated for this measure (each group respectively).||ng/ml||Full Range|Geometric Mean
724813|NCT00339144|Secondary|Mean Apparent Volume of Distribution (Vz/F) of Dasatinib|Apparent volume of distribution after oral dosing was obtained from plasma concentration versus time data.|Blood samples were collected at 0 hour (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 12 and 24 hours (post dose) on Days 14 and 28|All treated participants with adequate PK profiles (PK population). The 'n' signifies those participants who received study drug and were evaluated for this measure (each group respectively).||L||Full Range|Geometric Mean
724814|NCT00339144|Secondary|Mean Apparent Oral Clearance (CLo) of Dasatinib|Apparent oral clearance was obtained from the plasma concentration versus time data.|Blood samples were collected at 0 hour (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 12 and 24 hours (post dose) on Days 14 and 28|All treated participants with adequate PK profiles (PK population). The 'n' signifies those participants who received study drug and were evaluated for this measure (each group respectively).||L/hour||Full Range|Geometric Mean
724815|NCT00339144|Secondary|Accumulation Index (AI) of Dasatinib|AI of Dasatinib was calculated as ratio of geometric mean of AUC(TAU) (area under the plasma concentration versus time curve from time 0 to the time of the last measurable concentration) on Day 14 or Day 28 on Day 1.|Blood samples were collected at 0 hour (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 12 and 24 hours (post dose) on Days 1, 14 and 28|All treated participants with adequate PK profiles (PK population). The 'n' signifies those participants who received study drug and were evaluated for this measure (each group respectively).||ratio||Full Range|Geometric Mean
724816|NCT00339144|Secondary|Terminal Elimination Half-life (T-half) of Dasatinib|T-half of dasatinib was calculated using plasma concentration versus time data.|Blood samples were collected at 0 hour (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 12 and 24 hours (post dose) on Days 1, 14 and 28|All treated participants with adequate PK profiles (PK population). The 'n' signifies those participants who received study drug and were evaluated for this measure (each group respectively).||hours||Standard Deviation|Mean
724817|NCT00339144|Secondary|Time to Reach Maximum Observed Plasma Concentration of Dasatinib (Tmax)|Tmax, time to reach maximum observed plasma concentration of dasatinib was obtained directly from the plasma concentration versus time data.|Blood samples were collected at 0 hour (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 12 and 24 hours (post dose) on Days 1, 14 and 28|All treated participants with adequate PK profiles (PK population). The 'n' signifies those participants who received study drug and were evaluated for this measure (each group respectively).||hours||Full Range|Median
724818|NCT00339144|Secondary|AUC[TAU] of Dasatinib|Area under the plasma concentration-time curve within the dosing interval was determined. AUC(TAU), from time 0 to the time of the last measurable concentration (24 hours) was calculated for Day 1, 14, 28 respectively.|Blood samples were collected at 0 hour (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 12 and 24 hours (post dose) on Days 1, 14 and 28|All treated participants with adequate PK profiles (PK population). The 'n' signifies those participants who received study drug and were evaluated for this measure (each group respectively).||ng*hours/ml||Full Range|Geometric Mean
724819|NCT00339144|Secondary|Area Under the Plasma-concentration-time Curve [AUC (INF)] of Dasatinib on Day 1|AUC(INF), area under the plasma concentration-time curve from zero to the last time of the last quantifiable concentration within the dosing interval was calculated for Day 1.|Blood samples were collected at 0 hour (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 12 and 24 hours (post dose) on Day 1|All treated participants with adequate PK profiles (PK population).||ng*hours/ml||Full Range|Geometric Mean
724820|NCT00339144|Secondary|Maximum Plasma Concentration (Cmax) of Dasatinib|Cmax was obtained from the plasma concentration versus time data after oral administration of dasatinib.|Blood samples were collected at 0 hour (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 12 and 24 hours (post dose) on Days 1, 14 and 28|All treated participants with adequate pharmacokinetic (PK)profiles (PK population). The 'n' signifies those participants who received study drug and were evaluated for this measure (each group respectively).||nanograms (ng)/ml||Full Range|Geometric Mean
724821|NCT00339144|Secondary|Number of Participants With Clinically Significant Change in QT Interval Corrected for Heart Rate (QTcF)|QT interval corrected for heart rate (QTcF) was assessed using triplicate 12-lead serial ECGs.|Baseline, Day 1, Day 14 and Day 28|All participants who received at least one dose of the study drug (safety population).||participants|||Number
724822|NCT00339144|Secondary|Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings|Standard 12-lead ECG was used to record selected ECG parameters like RR interval (the time between the two R waves in ECG), PR interval (interval measured from the beginning of the P wave to the beginning of the QRS complex; QRS complex is the name for some of the deflections seen on a typical ECG)), QRS duration, QT interval (time between onset of ventricular depolarization and end of ventricular repolarization), QT interval corrected for heart rate using Bazett's (QTcB) and Fridericia's (QTcF) formulas.|From screening Day -1, and at pre-dose, 1 and 4 hours (post-dose) on Days 1, 14 and 28 in first treatment course, at pre-dose, 1 and 4 hours (post-dose) during the second and fourth week in subsequent courses and at the end of study|All participants who received at least one dose of the study drug (safety population).||participants|||Number
727505|NCT00376168|Primary|Change From Baseline in Spleen Volume Measured by MRI.|Calculated as percent change in spleen volume from Baseline to 9 months|Baseline and 9 months|Intent to treat||percentage of change||Standard Deviation|Mean
724823|NCT00339144|Secondary|Number of Participants With Clinically Meaningful Vital Signs|Vital signs measurements (including blood pressure, body temperature and pulse rate) were recorded. The investigator used his/her clinical judgment to decide whether or not abnormalities in vital signs were clinically significant.|From screening, Day 1 , 8, 15 and 22 in the 1st treatment course, Day 8 and 22 in the second and subsequent courses and at the end of study|All participants who received at least one dose of the study drug (safety population).||participants|||Number
724824|NCT00339144|Secondary|Number of Participants With Clinically Meaningful Physical Examination Measures|Interim and final physical examinations were performed. The investigator used his/her clinical judgment to decide whether or not physical examination findings were clinically significant.|From screening, Day 1 in each treatment course and at the end of study|All participants who received at least one dose of the study drug (safety population). Analysis for significant physical examination findings was not done.||participants|||Number
724825|NCT00339144|Secondary|Most Frequent Serum Chemistry Laboratory Abnormalities Occurring in >=10% Participants: High Magnesium|Abnormalities were graded according to the NCI-CTC, version 3.0 (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening). Most frequent (>=10%) serum laboratory abnormalities were recorded. The following definitions specify the NCI-CTC AE criteria for serum laboratory abnormalities in the data presented: magnesium: Grade 3: >3.0 - 8.0 mg/dL or >1.23 - 3.30 mmol/L, Grade 4: >8.0 mg/dL or >3.30 mmol/L.|From start of study drug therapy up to 30 days after the last dose.|All participants who received at least one dose of the study drug (safety population).||participants|||Number
724826|NCT00339144|Secondary|Most Frequent Grade 3-4 Hematology Abnormalities Occurring in >=10% Participants: Low Lymphocyte Count|Abnormalities were graded according to the NCI CTC, version 3.0 (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening). Most frequent hematology Grade 3 and 4 abnormalities occurring in >=10% participants were recorded. Grade 3 and 4 criteria are as follows: lymphocyte count: Grade 3: 0.2 - <0.5*10^9/L, Grade 4: <0.2*10^9/L.|From start of study drug therapy up to 30 days after the last dose.|All treated participants who received at least one dose of the study drug.||participants|||Number
724827|NCT00339144|Secondary|Number of Participants With Grade 3-4 Serum Chemistry Abnormalities|Abnormalities were graded according to the NCI CTC, version 3.0 (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening). Grade 3 and 4 criteria are as follows: phosphorous: Grade 3: 1.0-<2.0 mg/dL, Grade 4: <1.0 mg/dL; calcium: Grade 3: 6.0-<7.0 or >12.5-13.5 mg/dL, Grade 4: <0.6->13.5 mg/dL; magnesium: Grade 3: >3.0 – 8.0 mg/dL or >1.23 – 3.30 mmol/L, Grade 4: >8.0 mg/dL or >3.30 mmol/L; albumin: Grade 3: <2 g/dL or <20 g/L.|From start of study drug therapy up to 30 days after the last dose.|All participants who received at least one dose of the study drug.||participants|||Number
724828|NCT00339144|Secondary|Number of Participants With Grade 3 or 4 Hematology Abnormalities|Hematology abnormalities were graded per the National Cancer Institute (NCI) Common. Terminology Criteria (CTC) version 3.0 criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening). Grade 3 and 4 criteria are as follows: Absolute Neutrophil Count (ANC): Grade 3: 0.5 - <1.0*10^9/L, Grade 4: <0.5*10^9/L; lymphocytes: Grade 3: 0.2 - <0.5*10^9/L, Grade 4: <0.2*10^9/L.|From start of study drug therapy up to 30 days after the last dose.|All participants who received at least one dose of the study drug.||participants|||Number
724829|NCT00339144|Secondary|Number of Participants Who Died, Experienced Adverse Events (AEs), Serious AEs (SAEs), Drug Related AEs and Discontinued Due to AEs|AEs: any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to an AE were recorded. Drug-related AEs: events with a relationship to the study therapy of certain; probable; possible; not likely or unrelated.|From start of study drug therapy up to 30 days after the last dose.|All participants who received at least one dose of the study drug (safety population).||participants|||Number
724830|NCT00339144|Primary|Maximum Tolerated Dose (MTD) and Maximum Acceptable Dose (MAD) of Dasatinib as Determined by Number of Participants With Dose-Limiting Toxicities (DLTs) Related to Dasatinib Treatment|MAD: highest dose level at which >=1 DLTs were reported, MTD: dose one step lower than MAD. DLT: any of the following considered related to dasatinib during course 1:Grade 3(dose reduction by 1 dose level)/Grade 4:recurring nausea, vomiting or diarrhea; any other Grade >=3 non-hematologic toxicity except alopecia or fatigue;any grade toxicity requiring two dose reductions or participant's discontinuation; Grade 4 neutropenia <500 cells/mm^3 for >=5 consecutive days or febrile neutropenia; Grade 4 thrombocytopenia <25,000 cells/mm^3 or Grade 3 bleeding requiring platelet transfusion.|From start of the treatment i.e.Day 1 to end of Cycle 1 i.e. Day 30 (4 weeks)|All treated participants who received at least one dose of the study drug and were evaluable for DLT.||participants|||Number
724831|NCT00339183|Secondary|Number of Participants With Adverse Events (AEs)|"A serious adverse event (SAE) is defined by regulatory authorities as one that • is fatal • is life threatening (places the subject at immediate risk of death) • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • other significant medical hazard. The relationship of the adverse event to the study treatment was assessed by the Investigator by means of the question: “Is there a reasonable possibility that the event may have been caused by the study treatment?"|From randomization until the data cut-off date of 30 April 2009. Maximum follow-up time was 33 months.|Safety analysis set: all participants who received at least 1 dose of panitumumab or chemotherapy. One participant was randomized to Panitumumab Plus FOLFIRI, but received FOLFIRI Alone and is included in the FOLFIRI Alone group for safety analyses.||participants|||Number
724832|NCT00339183|Secondary|Duration of Response|"Calculated only for those participants with an objective response as the time from the first objective response (subsequently confirmed within no less than 4 weeks) to first observed disease progression per modified-RECIST criteria. Participants not meeting these criteria by the analysis data cutoff date were censored at their last evaluable disease assessment date.
Progressive disease is defined as a ≥ 20% increase in the size of target lesions or unequivocal progression of existing non-target lesions or any new lesions."|From randomization until the data cut-off date of 30 April 2009. Maximum follow-up time was 33 months|KRAS Central Tumor Response Analysis Set: Responders||months||95% Confidence Interval|Median
724833|NCT00339183|Secondary|Time to Disease Progression|"Time to progression was defined as the time from the randomization date to the date of first observed disease progression per the modified RECIST criteria. Participants not meeting these criteria by the analysis data cutoff date were censored at their last evaluable disease assessment date.
Progressive disease is defined as a ≥ 20% increase in the size of target lesions or unequivocal progression of existing non-target lesions or any new lesions."|From randomization until the data cut-off date of 30 April 2009. Maximum follow-up time was 33 months|KRAS Efficacy Analysis Set||months||95% Confidence Interval|Median
724834|NCT00339183|Secondary|Percentage of Participants With an Objective Response|Participants were evaluated for tumor response per the modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria every 8 weeks until disease progression. Objective response was defined as the incidence of either a confirmed complete or partial response (CR or PR) while on study, as determined by blinded independent central review and confirmed no less than 4-weeks after the criteria for response are first met. CR: Disappearance of all target and non-target lesions and no new lesions. PR: At least a 30% decrease in the sum of the longest diameter of target lesions and no progression of non-target or no new lesions, or, disappearance of all target lesions and the persistence of ≥ 1 non-target lesion not qualifying for either CR or progressive disease. Participants without a post-baseline assessment were considered non-responders.|Every 8 weeks until disease progression up to the data cut-off date of 30 April 2009. Maximum time on follow-up was 33 months.|KRAS Central Tumor Response Analysis Set: subset of participants with at least one uni-dimensionally measurable lesion per the modified RECIST criteria per blinded central radiology review for whom KRAS was assessed.||percentage of participants||95% Confidence Interval|Number
724835|NCT00339183|Primary|Overall Survival|Overall survival was defined as the time from randomization to the date of death. Participants who had not died by the analysis data cutoff date had their time of death censored at their last contact date.|From randomization until the data cut-off date of 30 April 2009. Maximum follow-up time was 33 months|KRAS Efficacy Analysis Set||months||95% Confidence Interval|Median
724836|NCT00339183|Primary|Progression-free Survival (PFS)|"Progression-free survival was defined as the time from randomization to first disease progression per modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria or death, based on independent central radiological assessment. Participants who were alive but did not meet criteria for progression by the data cutoff date were censored at their last evaluable disease assessment date.
Progressive disease is defined as a ≥ 20% increase in the size of target lesions or unequivocal progression of existing non-target lesions or any new lesions."|From randomization until the data cut-off date of 8 April 2008. Maximum follow-up time was 17 months.|KRAS Efficacy Analysis Set (participants for whom KRAS status was assessed)||months||95% Confidence Interval|Median
724837|NCT00339833|Primary|Change in the Average Serum Insulin Concentration During the Last 40 Min of Clamp||last 40 min of clamp|||l/min||Standard Deviation|Mean
724838|NCT00339833|Primary|Change in Fasting Plasma Glucose Concentration||7 days|||mmol/l||Standard Deviation|Mean
724839|NCT00340379|Primary|Brief Psychiatric Rating Scale at 12 Weeks|A rating scale used to measure psychiatric symptoms such as depression, anxiety, hallucinations and unusual behaviour. Each symptom is rated 1-7 and in this version a total of 24 symptoms are scored. Thus the total range of scores is from a minimum of 24 to a maximum of 168. Lower scores are considered better, so the minimum total score of 24 indicates someone with no psychiatric symptoms, while any score over 40 is considered at least moderately severe, with only the most severely ill patients scoring over 60.|12 weeks|||units on a Psychiatric Rating scale||Standard Deviation|Mean
724840|NCT00340379|Primary|Clinical Global Impression Improvement Scale|A 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. Overall the scale goes from a minimum of 1(very much improved) to a maximum of 7(very much worse).|12 weeks|||units on a Clinical Impressions Scale||Standard Deviation|Mean
724841|NCT00340379|Primary|21 Item Hamilton Depression Rating Scale|The scale rates 21 symptoms related to major depression. A total score of 0-7 is considered to be normal, scores of 20 or higher indicate moderately severe depression. Total scores range from a minimum of 0(not ill) to a maximum of 64 (severely ill).|12 week|Number of participants was ITT and imputed by LOCF||Units on Hamilton Depression Scale||Standard Deviation|Mean
724842|NCT00340678|Secondary|Glomerular Volume||6 years after first treatment|Intention-to-treat||*10^6 cubic microns||Standard Deviation|Mean
724843|NCT00340678|Primary|Number of Participants With Decline in GFR|Participants were monitored for up to 6 years. This is the number of participants who had a decline in GFR to less than or equal to 60 ml/min or to half the baseline value in subjects that enter the study with a GFR of less than 120 ml/min during the time of observation.|Up to 6 years|Intention-to-treat||participants|||Number
724844|NCT00340704|Secondary|RA,Cmax|The accumulation ratio was calculated from the patients who were randomised to the low dose group and for whom both parameters at first dose and steady state dose were available. Accumulation ratios of tamsulosin HCl in plasma at steady state after multiple dose administration over a uniform dosing interval τ, expressed as ratio of Cmax at steady state and after single dose. The accumulation ratio RA,Cmax was calculated as: Cmax,ss/Cmax,1. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results from this group is provided.|−0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.|Pharmacokinetics steady state set (PK-SS)||Ratio||Geometric Coefficient of Variation|Geometric Mean
724845|NCT00340704|Secondary|Vz/F,ss,W,Norm|Weight-normalized Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following extravascular administration), Vz/F,ss,W,norm. Weight-normalized VzF,ss was calculated by dividing the respective quantities by body weight in kg. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided.|−0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.|Pharmacokinetics steady state set (PK-SS)||L/kg||Geometric Coefficient of Variation|Geometric Mean
724905|NCT00348686|Secondary|Change of Diastolic Blood Pressure (DBP)|"Change of Diastolic Blood Pressure was calculated and collected through the way of Last Observational carried forward.
Only who has diastolic blood pressure data both baseline and follow up was analyzed. Most of patient who enrolled, 302 have a data."|At Baseline and 24 weeks|Last Observational carried forward||mmHg||Full Range|Median
724846|NCT00340704|Secondary|CL/F,ss,W,Norm|Weight-normalized CL/F,ss (apparent clearance of the analyte in the plasma at steady state after extravascular multiple dose administration), CL/F,ss,W,norm. Weight-normalized CL/F,ss was calculated by dividing the respective quantities by body weight in kg. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided.|−0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.|Pharmacokinetics steady state set (PK-SS)||L/h/kg||Geometric Coefficient of Variation|Geometric Mean
724847|NCT00340704|Secondary|MRTpo,ss|Mean residence time of the analyte in the body at steady state after oral administration,MRTpo,ss. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided.|−0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.|Pharmacokinetics steady state set (PK-SS)||hours||Geometric Coefficient of Variation|Geometric Mean
724848|NCT00340704|Secondary|t1/2,ss|Terminal half-life of the analyte in plasma at steady state, t1/2,ss. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided.|−0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.|Pharmacokinetics steady state set (PK-SS)||hours||Geometric Coefficient of Variation|Geometric Mean
724849|NCT00340704|Secondary|λz,ss|Terminal rate constant of the analyte in plasma at steady state, λz,ss. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided.|−0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.|Pharmacokinetics steady state set (PK-SS)||1/hours||Geometric Coefficient of Variation|Geometric Mean
724850|NCT00340704|Secondary|AUCτ ,ss ,DW ,Norm|Dose- and weight-normalized of AUCτ ,ss ( AUCτ ,ss ,DW ,norm). Weight normalization of AUCτ,ss was performed by dividing the respective quantities by the reciprocal of body weight in kg. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided.|−0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.|Pharmacokinetics steady state set (PK-SS)||ng*h/mL/mg*kg||Geometric Coefficient of Variation|Geometric Mean
724851|NCT00340704|Secondary|AUCτ,ss|Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ , AUCτ,ss. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided.|−0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.|Pharmacokinetics steady state set (PK-SS)||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
724852|NCT00340704|Secondary|Tmax,ss|Time from last dosing to maximum concentration of the analyte in plasma at steady state over a uniform dosing interval τ, tmax,ss. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided.|−0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.|Pharmacokinetics steady state set (PK-SS)||hours||Full Range|Median
724853|NCT00340704|Secondary|Cmin,ss|Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ, Cmin,ss. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided.|−0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.|Pharmacokinetics steady state set (PK-SS)||ng/mL||Geometric Coefficient of Variation|Geometric Mean
724854|NCT00340704|Secondary|Cmax,ss, DW, Norm|Dose- and weight-normalized for Cmax,ss, Cmax,ss, DW, norm. Weight normalization of Cmax,ss was performed by dividing the respective quantities by the reciprocal of body weight in kg. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided.|−0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.|Pharmacokinetics steady state set (PK-SS)||ng/mL/mg*kg||Geometric Coefficient of Variation|Geometric Mean
724855|NCT00340704|Secondary|Cmax,ss|Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ, Cmax,ss. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided.|−0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.|Pharmacokinetics steady state set (PK-SS)||ng/mL||Geometric Coefficient of Variation|Geometric Mean
724856|NCT00340704|Secondary|Cpre,ss|Pre-dose concentration of the analyte in plasma at steady state immediately before administration of the next dose, Cpre,ss. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided.|−0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.|Pharmacokinetics steady state set (PK-SS): This set includes subjects who were randomized successfully took study medication for two weeks at their randomized dose level and provided blood samples for PK at their steady state visit.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
724857|NCT00340704|Secondary|Cmax, 1 ,DW ,Norm|Dose- and weight-normalized Cmax,1 (Cmax,1,DW,norm). Weight normalization of Cmax,1 was performed by dividing the respective quantities by the reciprocal of body weight in kg. This Outcome Measure was only pre-specified for PK Study- single dose group subjects, so results of this group is provided.|−0.25h prior to dose and 2h, 4h, 6h and 8h after the drug administration.|Pharmacokinetics single dose set (PK-SD)||ng/mL/mg*kg||Geometric Coefficient of Variation|Geometric Mean
724858|NCT00340704|Secondary|Tmax, 1|Time from dosing to maximum measured concentration of the analyte in plasma after administration of the first dose, tmax, 1. This Outcome Measure was only pre-specified for PK Study- single dose group subjects, so results of this group is provided.|−0.25h prior to dose and 2h, 4h, 6h and 8h after the drug administration.|Pharmacokinetics single dose set (PK-SD)||hours||Full Range|Median
724859|NCT00340704|Secondary|Cmax,1|Maximum measured concentration of the analyte in plasma following the first dose, Cmax,1. This Outcome Measure was only pre-specified for PK Study- single dose group subjects, so results of this group is provided.|−0.25h prior to dose and 2h, 4h, 6h and 8h after the drug administration.|Pharmacokinetics single dose set (PK-SD): This set includes subjects who were randomized, successfully took and retained the first dose of study medication and provided blood samples for PK at Visit 2.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
724906|NCT00348686|Secondary|Change of Systolic Blood Pressure (SBP)|Change of Systolic Blood Pressure was calculated and collected through the way of Last Observational carried forward.|At Baseline and 24 weeks|Only who has systolic blood pressure data both baseline and follow up was analyzed. Most of patient who enrolled, 302 have a data.||mmHg||Full Range|Median
724860|NCT00340704|Secondary|Vision Testing for Group D-527.51 Rollover|Number of subjects with a change from baseline in visual acuity by treatment group (subjects are classified according to the treatment they were taking at end of treatment). They were analysed based on the below mentioned category in both the Eyes: 1) No Change 2) Decrease in visual acuity 3) Increase in visual acuity 4) Missing. Missing includes subjects with no baseline exam and subjects with exam scores missing. This Outcome Measure was only pre-specified for Group D-527.51 Rollover subjects, so results of this group is provided.|Baseline and Week 52|Treated Set (TS)||Participants|||Number
724861|NCT00340704|Secondary|Vision Testing for Group D-Denovo|Number of subjects with a change from baseline in visual acuity by treatment group (subjects are classified according to the treatment they were taking at Week 52 or end of treatment). They were analysed based on the below mentioned category in both the Eyes: 1) No Change 2) Decrease in visual acuity 3) Increase in visual acuity 4) Missing. Missing includes subjects with no baseline exam and subjects with exam scores missing. This Outcome Measure was only pre-specified for Group D-Denovo subjects, so results of this group is provided.|Baseline, Week 26 and Week 52.|Treated Set (TS)||Participants|||Number
724862|NCT00340704|Secondary|Number of Participants With Clinically Relevant Abnormalities for Physical Examination, Vital Signs/Orthostatic Testing, Electrocardiogram (ECG), Laboratory Values, Urinalysis, Occurence of Adverse Events and Cognitive Testing for Group D-Denovo|Number of participants with Clinically Relevant Abnormalities for Physical Examination, Vital Signs/Orthostatic testing, Electrocardiogram (ECG), Laboratory Values, Urinalysis, Occurence of Adverse events and Cognitive Testing. Relevant findings or worsening of baseline conditions were reported as adverse events. Subjects who experienced orthostatic hypotension during orthostatic testing were reported as adverse events. This Outcome Measure was only pre-specified for Group D-Denovo, so results of this group is provided.|From first drug administration until 28 days after last study drug administration, upto 450 days|Treated Set (TS)||Participants|||Number
724863|NCT00340704|Secondary|Number of Participants With Clinically Relevant Abnormalities for Physical Examination, Vital Signs/Orthostatic Testing, Electrocardiogram (ECG), Laboratory Values,Urinalysis,Occurence of Adverse Events & Cognitive Testing for Group D-527.51 Rollover|Number of participants with Clinically Relevant Abnormalities for Physical Examination, Vital Signs/Orthostatic testing, Electrocardiogram (ECG), Laboratory Values, Urinalysis, Occurence of Adverse events and Cognitive Testing. Relevant findings or worsening of baseline conditions were reported as adverse events. Below mentioned result are the number of subjects who had the clinical relevant abnormalities for the preferred term 'Hepatic enzyme increased'. This Outcome Measure was only pre-specified for Group D-527.51 Rollover subjects, so results of this group is provided.|From first drug administration until 28 days after last study drug administration, upto 395 days|Treated Set (TS)||Participants|||Number
724864|NCT00340704|Secondary|LPP Response at Any Time During the Trial for Group D-Denovo and Group D-527.51 Rollover|Response rates of LPP responders (2 LPP values < 40 cm H2O) at any time during the trial by treatment group. Timeframe for Group D-Denovo: Low dose: Week 1, 3 & 4 prior to dose and Week 2, 9 & 26 (optional), 13(additional) & 52 post dose. Medium dose: Week 1, 2 & 4 prior to dose and Week 3, 9(optional), 13(additional), 26 (optional) & 52 post dose. High dose: Week 1, 2 & 3 prior to dose administration and Week 4, 9(optional), 13(additional), 26 (optional) & 52 post dose. Group D-527.51 Rollover: Week 1, 2, 3 & 4 prior to dose and Week 9 &26 (optional),13 (additional) & 52 post dose. This Outcome Measure was only pre-specified for Group D-Denovo and Group D-527.51 Rollover subjects, so results of these two groups are provided.|Week 1 to Week 52 (described study wise in the Description).|Full analysis set (FAS-LPP)||participants|||Number
724865|NCT00340704|Secondary|Response Defined as Stabilization or Improvement of Hydronephrosis Measured by Renal Ultrasound Compared to Baseline for Group D-Denovo and Group D-527.51 Rollover|Response defined as stabilization or improvement of hydronephrosis measured by renal ultrasound compared to baseline by treatment group (subjects are classified according to the treatment they were taking at Week 52 or end of treatment) at week 52 for Group D-Denovo and (subjects are classified according to the treatment they were taking at the end of treatment) at last value on treatment for Group D-527.51 Rollover. Baseline assessments were obtained from trial 527.51 for Group D-527.51 Rollover. The overall treatment duration was not sufficient to reach any meaningful conclusions regarding improvement or stabilization of hydronephrosis in the Group D-527.51 Rollover. Hydronephrosis response is defined as an improvement or stabilization based upon ultrasound grading at the end of the study. The lower or same grade at end of treatment compared to baseline is considered an improvement or stabilization.|Group D-Denovo: Baseline and Week 52. Group D-527.51 Rollover: Baseline, Week 26 and Week 52.|Full analysis set (FAS-RENAL). This Outcome Measure was only pre-specified for Group D-Denovo and Group D-527.51 Rollover subjects, so results of these two groups are provided.||Participants|||Number
724866|NCT00340704|Secondary|Response Defined as Stabilization or Improvement of Hydroureter Measured by Renal Ultrasound Compared to Baseline for Group D-Denovo and Group D-527.51 Rollover|Response defined as stabilization or improvement of hydroureter measured by renal ultrasound compared to baseline by treatment group (subjects are classified according to the treatment they were taking at Week 52 or end of treatment) at week 52 for Group D-Denovo and (subjects are classified according to the treatment they were taking at the end of treatment) at last value on treatment for Group D-527.51 Rollover. Baseline assessments were obtained from trial 527.51 for Group D-527.51 Rollover. The overall treatment duration was not sufficient to reach any meaningful conclusions regarding improvement or stabilization of hydroureter in the Group D-527.51 Rollover. Hydroureter response is defined as improvement or stabilization based upon the presence or absence of hydroureter at end of treatment compared to baseline. This Outcome Measure was only pre-specified for Group D-Denovo and Group D-527.51 Rollover subjects, so results of these two groups are provided.|Group D-Denovo: Baseline and Week 52. Group D-527.51 Rollover: Baseline, Week 26 and Week 52.|Full analysis set (FAS-RENAL): Includes all patients in the Treated set who received one dose of treatment and had one on treatment renal measurement.||Participants|||Number
724867|NCT00340704|Secondary|Percent Change From Baseline in LPP for Group D-527.51 Rollover|Percent change from baseline in actual detrusor leak point pressure (LPP) by treatment group (subjects are classified according to the treatment they were taking at end of treatment) and Week. Baseline assessments were obtained from trial 527.51 for Group D-527.51 Rollover. The results from Week 1 were reported because there were very few subjects who reported data at subsequent visits due to the termination of the trial. This Outcome Measure was only pre-specified for Group D-527.51 Rollover subjects, so results of this group is provided.|Baseline and Week 1|Full analysis set (FAS-LPP)||percent change||Standard Deviation|Median
724868|NCT00340704|Secondary|Change From Baseline in LPP for Group D-527.51 Rollover|Median change from baseline in detrusor leak point pressure (LPP) by treatment group (subjects are classified according to the treatment they were taking at end of treatment) and week. Baseline assessments were obtained from trial 527.51 for Group D-527.51 Rollover. The results from Week 1 were reported because there were very few subjects who reported data at subsequent visits due to the termination of the trial. This Outcome Measure was only pre-specified for Group D-527.51 Rollover subjects, so results of this group is provided.|Baseline and week 1|Full analysis set (FAS-LPP)||cm H2O||Standard Deviation|Median
724869|NCT00340704|Secondary|Early Responders Who Maintained Their LPP Below 40 cm H2O During the Study for Group D-Denovo and Group D-527.51 Rollover|Early responders who maintained their detrusor leak point pressure (LPP) below 40 cm H2O during the study. Timeframe for Group D-Denovo: Low dose: Week 1, 3 & 4 prior to dose and Week 2, 9 & 26 (optional), 13(additional) & 52 post dose. Medium dose: Week 1, 2 & 4 prior to dose and Week 3, 9(optional), 13(additional), 26 (optional) & 52 post dose. High dose: Week 1, 2 & 3 prior to dose administration and Week 4, 9(optional), 13(additional), 26 (optional) & 52 post dose. Group D-527.51 Rollover: Week 1, 2,3 & 4 prior to dose and Week 9 &26 (optional),13 (additional) & 52 post dose. This Outcome Measure was only pre-specified for Group D-Denovo and Group D-527.51 Rollover subjects, However this endpoint was not analysed for Group D-527.51 Rollover as very limited data were collected due to early termination of the study & no alternative endpoint was defined in the Group D-527.51 rollover, so only the results for Group D-Denovo is provided.|Week 1 to Week 52 (Time frame for all weeks are described study wise in the Description).|Full analysis set (FAS-LPP)||Participants|||Number
724870|NCT00340704|Primary|Number of LPP Responders at Each Visit Over Time (Classified by Last Value on Treatment) for Group D-527.51 Rollover.|Number of Leak point pressure (LPP) Responders at each visit (week) over time (classified by last value on treatment). Due to the early termination of the study, most of the LPP assessments were conducted within Weeks 1-9 of treatment. Summary of LPP response rates provided over time.The subjects are classified according to the treatment they were receiving at the last value on treatment. Therefore, no assumptions can be made regarding what dose they were receiving at a particular time point. LD: Low Dose, MD: Medium Dose and HD: High Dose This Outcome Measure was only pre-specified for Group D-527.51 Rollover subjects, so results of this group is provided.|Week 1 (Visit 3) , Week 2 (Visit 4) , Week 3 (Visit 5) and Week 4 (Visit 6) prior to dose administration and Week 9 (Visit 7) (optional), Week 13 (Visit 8) (additional), Week 26 (Visit 9) (optional) and Week 52 (Visit 11) after drug administration.|Full analysis set (FAS-LPP)||Participants|||Number
724871|NCT00340704|Primary|Percentage of LPP Responders for Group D-Denovo and Group D-527.51 Rollover|Group D-Denovo: Leak point pressure (LPP) Response at(response defined as a subject who achieves an LPP pressure <40 cm H2O) at the end of treatment based on two confirmatory values. Group D-527.51 Rollover: Leak point pressure (LPP) Response at (response defined as a subject who achieves an LPP pressure <40 cm H2O) last value of the treatment based on two confirmatory values. The last value on treatment included any final value prior to discontinuation of treatment, regardless of the length of treatment. Detrusor leak point pressure (LPP) recorded in cm H2O which was obtained using a standard urodynamic technique, a cystometrogram. Descriptive statistics were used to assess this endpoint. This Outcome Measure was only pre-specified for Group D-Denovo and Group D-527.51 Rollover subjects, so results of these two groups are provided.|Group D-Denovo: Week 52. Group D-527.51 Rollover: Week 1, Week 2, Week 3 and Week 4 prior to dose administration and Week9 (optional), Week 13 (additional), Week 26 (optional) and Week 52 after drug administration.|Full analysis set (FAS-LPP): This subject set includes all subjects in the Treated set who received one dose of treatment and had one on treatment LPP measurement.||percentage of responders|||Number
724872|NCT00340834|Secondary|Percentage of Participants Free of 3-month and 6-month Disability Progression Assessed With the Expanded Disability Status Scale (EDSS) at the End of the Extension Phase of the Study|The EDSS is a scale for assessing disability in 8 functional systems (visual, brain stem, pyramidal, cerebellar, sensory, bowel & bladder, cerebral, other functions). An overall score ranging from 0 (normal) to 10 (death due to MS) is calculated. Disability progression was determined by the EDSS score based on the following criteria: One point increase from baseline in patients with baseline EDSS score from 0 to 5.0; or half a point increase in patients with baseline EDSS score of 5.5 or above. Percent of patients free of disability progression was calculated using the Kaplan-Meier method.|Baseline to end of study (up to approximately 4.5 years)|Intent-to-treat population (ITT): All randomized patients who received at least 1 dose of study medication.||Percentage of participants||95% Confidence Interval|Number
724873|NCT00340834|Secondary|Number of New or Newly Enlarged T2 Lesions in the Extension Phase of the Study|The number of new or newly enlarged T2 lesions in comparison to baseline was assessed with T2-weighted magnetic resonance image (MRI) scans. A T2-weighted MRI scan utilizes particular values of the echo time (TE) and the repetition time (TR) parameters of image acquisition. Inflammation and tissue damage are seen as bright areas in T2 images and are often referred to as T2 lesions. T2-weighted MRI scans are a sensitive way to evaluate the brain for demyelinating diseases, such as multiple sclerosis.|Month 12 to end of study (up to approximately 3.5 years)|Intent-to-treat population (ITT): All randomized patients who received at least 1 dose of study medication.||T2 lesions||Standard Deviation|Mean
724874|NCT00340834|Secondary|Estimated Annualized Aggregate Relapse Rate (ARR) in the Core and Extension Phases of the Study|The ARR is defined as the number of confirmed relapses in a year. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. The annualized ARR for each treatment group was calculated using negative binomial regression adjusted by treatment, country, number of relapses in the previous 2 years, and the baseline Expanded Disability Status Scale score.|Month 0 to end of study (up to approximately 4.5 years)|Intent-to-treat population (ITT): All patients who were randomized and received at least 1 dose of study medication.||Estimated relapses per year||95% Confidence Interval|Number
724907|NCT00348686|Secondary|LVH(Left Ventricular Hypertrophy) Regression by Echocardiac Parameter, Left Ventricular Mass Index|Change of Left Ventricular Hypertrophy(LVH) by Echocardiac Parameter, Left Ventricular mass Index (LVMI) was calculated and collected through the way of Last Observational carried forward. LVH/Index was calculated like this: Divide LV mass with Body Surface Area.|At Baseline and 24 weeks|Only 245 patients who have reliable Echocardiac data were analyzed.||g/m^2||Full Range|Median
724875|NCT00340834|Secondary|Percentage of Participants Free of 3-month Disability Progression Assessed With the Expanded Disability Status Scale (EDSS) at the End of the Core Phase of the Study|The EDSS is a scale for assessing disability in 8 functional systems (visual, brain stem, pyramidal, cerebellar, sensory, bowel & bladder, cerebral, other functions). An overall score ranging from 0 (normal) to 10 (death due to MS) is calculated. Disability progression was determined by the EDSS score based on the following criteria: One point increase from baseline in patients with baseline EDSS score from 0 to 5.0; or half a point increase in patients with baseline EDSS score of 5.5 or above. Percent of patients free of disability progression was calculated using the Kaplan-Meier method.|Baseline to Month 12|Intent-to-treat population (ITT): All randomized patients who received at least 1 dose of study medication.||Percentage of participants||95% Confidence Interval|Number
724876|NCT00340834|Secondary|Number of New or Newly Enlarged T2 Lesions in Comparison With Baseline in the Core Phase of the Study|The number of new or newly enlarged T2 lesions in comparison to baseline was assessed with T2-weighted magnetic resonance image (MRI) scans. A T2-weighted MRI scan utilizes particular values of the echo time (TE) and the repetition time (TR) parameters of image acquisition. Inflammation and tissue damage are seen as bright areas in T2 images and are often referred to as T2 lesions. T2-weighted MRI scans are a sensitive way to evaluate the brain for demyelinating diseases, such as multiple sclerosis.|Baseline to Month 12|Intent-to-treat population (ITT): All randomized patients who received at least 1 dose of study medication.||T2 lesions||Standard Deviation|Mean
724877|NCT00340834|Primary|Estimated Annualized Aggregate Relapse Rate (ARR) in the Core Phase of the Study|The ARR is defined as the number of confirmed relapses in a year. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. The annualized ARR for each treatment group was calculated using negative binomial regression adjusted by treatment, country, number of relapses in the previous 2 years, and the baseline Expanded Disability Status Scale score.|Baseline to Month 12|Intent-to-treat population (ITT): All patients who were randomized and received at least 1 dose of study medication.||Estimate relapses per year||95% Confidence Interval|Number
724878|NCT00347009|Primary|Number of Participants With Histologic Improvement at Month 36 (Per Protocol Population)|The Ishak fibrosis score is a scoring system (ranging from 0 to 6) that measures the degree of fibrosis (scarring) of the liver, which is caused by chronic necroinflammation (an inflammatory process in the liver including or leading to death of liver cells). A score of 0 represents no fibrosis, and a score of 6 represents established cirrhosis. Participants were classified as improved if the Ishak fibrosis score at Month 36 was 1 or more points less from the Screening score.|Screening and Month 36|Per Protocol (PP) Population: all participants in the ITT Population with interpretable liver biopsies at baseline and at the 36-month follow-up visit and without major violations of the protocol||participants|||Number
724879|NCT00347009|Secondary|Number of Participants Who Were HBsAg Positive at Baseline, With HBsAg Seroconversion at Months 12, 24, and 36|HBsAg seroconversion was defined as a decrease in HBsAg to undetectable levels and a gain of detectable levels of Hepatitis B surface antibody (HBsAb).|Baseline and Months 12, 24, and 36|ITT Population||participants|||Number
724880|NCT00347009|Secondary|Number of Participants Who Were Hepatitis B Surface Antigen (HBsAg) Positive at Baseline and Developed Undetectable Levels of HBsAg at Months 12, 24, and 36|HBsAg positive was defined as the presence of a detectable level of HBsAg.|Baseline and Months 12, 24, and 36|ITT Population||participants|||Number
724881|NCT00347009|Secondary|Number of Participants Who Were HBeAg Positive at Baseline, With HBeAg Seroconversion at Months 12, 24, and 36|HBeAg seroconversion was defined as a decrease in HBeAg to undetectable levels and a gain of detectable levels of Hepatitis B envelope antibody (HBeAb).|Baseline and Months 12, 24, and 36|ITT Population||participants|||Number
724882|NCT00347009|Secondary|Number of Participants Who Were Hepatitis B Envelope Antigen (HBeAg) Positive at Baseline and Developed Undetectable Levels of HBeAg at Months 12, 24, and 36|HBeAg positive was defined as the presence of a detectable level of HBeAg.|Baseline and Months 12, 24, and 36|ITT Population||participants|||Number
724883|NCT00347009|Secondary|Number of Participants With Alanine Aminotransferase (ALT) Normalization at Months 12, 24, and 36|ALT levels were measured as part of the liver function tests. Participants with ALT normalization at each visit were defined as those with a value below the upper limit of the normal (ULN) range for ALT provided by that site at the respective visit.|Months 12, 24, and 36|ITT Population||participants|||Number
724884|NCT00347009|Secondary|Number of Participants With Virological Breakthrough at Months 12, 24, and 36|Virological breakthrough was defined as an increase in serum HBV DNA levels by more than 1 log10 copies/ml from treatment nadir, i.e., the lowest HBV DNA value during the study.|Months 12, 24, and 36|ITT Population||participants|||Number
724885|NCT00347009|Secondary|Number of Participants With Undetectable HBV DNA at Months 12, 24, and 36|Undetectable HBV DNA was defined as an HBV DNA level below the lower limit of detection (LLOD) of 300 copies/ml.|Months 12, 24, and 36|ITT Population||participants|||Number
724886|NCT00347009|Secondary|Number of Participants Achieving Virological Response (HBV DNA Level <= 10^4 Copies/ml) at Months 12, 24, and 36|Virological response was defined as an HBV DNA level <= 10^4 copies/ml.|Months 12, 24, and 36|ITT Population||participants|||Number
724887|NCT00347009|Secondary|Number of Participants Achieving Virological Response (HBV DNA Level <= 10^3 Copies/ml) at Months 12, 24, and 36|Virological response was defined as an HBV DNA level <= 10^3 copies/ml.|Months 12, 24, and 36|ITT Population||participants|||Number
724888|NCT00347009|Secondary|Change From Baseline in Serum Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Level at Months 12, 24, and 36|The levels of HBV DNA in serum were measured using the Amplicor Cobas assay by Roche Diagnostics (detection limit 300 copies/milliliter [ml]). Changes from baseline in the serum HBV DNA level at Months 12, 24 and 36 were calculated as Month 12 minus baseline, Month 24 minus baseline, and Month 36 minus baseline respectively. Change is reported in log10 units.|Baseline and Months 12, 24, and 36|ITT Population||log10 copies/ml||Standard Deviation|Mean
724908|NCT00348686|Primary|Percent Change of B Type Natriuretic Peptides (BNP) Level|Change of B Type Natriuretic Peptides Level of the Subjects With Hypertension and Left Ventricular Hypertrophy (LVH) Treated With Candesartan Based Therapy for 24 Weeks was calculated just as the later time point minus the earlier time point. No specific calculation was used.|At Baseline and 24 weeks|Followed Intent-to-treat analysis||Percent Change||Full Range|Median
724889|NCT00347009|Secondary|Number of Participants With a Reduction From Screening of at Least 2 Points in the Knodell Necroinflammation Score at Month 36|The Knodell scoring system, also called the Histologic Activity Index (HAI), classifies liver biopsy specimens according to scores into 4 categories of histologic features: (I) periportal and/or bridging necrosis (scores from 0 to 10); (II) intralobular degeneration and focal necrosis (scores from 0 to 4); (III) portal inflammation (scores from 0 to 4); (IV) fibrosis (scores from 0 to 4). The Knodell necroinflammation score is the sum of scores from Parts I-III, hence a range of 0 to 18, and measures the degree of acute necroinflammatory activity in the liver.|Screening and Month 36|ITT Population||participants|||Number
724890|NCT00347009|Secondary|Number of Participants With a Reduction From Baseline in the Child-Pugh Score by 2 Points or More at Months 12, 24, and 36|The Child-Pugh score (modified version for scoring prothrombin time against reference range) was used in the study to assess the prognosis of chronic liver disease, mainly cirrhosis. The score employs five clinical measures of liver disease: encephalopathy, ascites, albumin, prothrombin time, and bilirubin. Each measure is scored on a scale of 1-3, with 1 being normal and 3 indicating most severe derangement. The total score for the Child-Pugh assessment was calculated as the sum of the 5 contributing scores, with a score range of 5 (best prognosis) to 15 (worst prognosis).|Baseline and Months 12, 24, and 36|ITT Population||participants|||Number
724891|NCT00347009|Primary|Number of Participants With Histologic Improvement at Month 36 (Intent-to-Treat Population)|The Ishak fibrosis score is a scoring system (ranging from 0 to 6) that measures the degree of fibrosis (scarring) of the liver, which is caused by chronic necroinflammation (an inflammatory process in the liver including or leading to death of liver cells). A score of 0 represents no fibrosis, and a score of 6 represents established cirrhosis. Participants were classified as improved if the Ishak fibrosis score at Month 36 was 1 or more points less from the Screening score.|Screening and Month 36|Intent-to-Treat (ITT) Population: all participants who received at least one dose of study medication, regardless of whether the participants completed the planned duration of the study||participants|||Number
724892|NCT00347022|Primary|Creatinine Clearance|The variation of creatinine clearance before and after the product injection was measured|between 48h before the contrast medium administration and 72h +/-12h after contrast medium administration|||percent change||Standard Deviation|Mean
724893|NCT00347269|Secondary|Functioning Outcomes as Measured by 3-item Sheehan Disability Scales and SF-12 and Disorder-specific Severity Scales as Measured by the ASI, PDSS-SR, GADS (Modified), SPIN, PCL-C, and the PHQ-9||Measured at Month 18||||||
724894|NCT00347269|Primary|BSI-12 (Anxiety and Somatization Subscales)|12 items from the Brief Symptom Inventory that measure anxiety and anxiety0related physical symptoms|Measured at Month 18|||number of responders|||Number
724895|NCT00347308|Primary|Eyebrow Position|Position of eyebrow at the medial canthus relative to orbital rim|At time of evaluation|||mm||Standard Deviation|Mean
724896|NCT00348556|Secondary|Change in Urinary Sodium Excretion at 24 Hours||baseline, 24 hours after start of infusion||||||
724897|NCT00348556|Primary|Change in Glomerular Filtration Rate (GFR) at 24 Hours||baseline, 24 hours after start of infusion||||||
724898|NCT00348673|Other Pre-specified|Time to Reach Maximum Observed Plasma Concentration at Steady State (Tmax,ss)||0 (pre-dose), 1, 2, 3, 4, 6, 12 hours post-dose; additional 24 hours post-dose for once daily regimen on Day 8|Per protocol pharmacokinetic analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-dose pharmacokinetic concentration.||hrs||Full Range|Median
724899|NCT00348673|Other Pre-specified|Maximum Observed Plasma Concentration at Steady State (Cmax,ss)||0 (pre-dose), 1, 2, 3, 4, 6, 12 hours post-dose; additional 24 hours post-dose for once daily regimen on Day 8|Per protocol pharmacokinetic analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-dose pharmacokinetic concentration.||ng/mL||Standard Deviation|Geometric Mean
724900|NCT00348673|Other Pre-specified|Area Under the Curve From Time Zero to End of Dosing Interval at Steady State (AUCtau,ss)|AUCtau = Area under the plasma concentration versus time curve from time zero (pre-dose) to the end of the dosing interval (tau), the dosing interval was 12 hours for twice daily regimen and 24 hours for once daily regimen.|0 (pre-dose), 1, 2, 3, 4, 6, 12 hours post-dose; additional 24 hours post-dose for once daily regimen on Day 8|Per protocol pharmacokinetic analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-dose pharmacokinetic concentration.||nanogram*hour/milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
724901|NCT00348673|Secondary|Number of Participants With Time to Rebound of Human Immunodeficiency Virus (HIV) Viral Load|Time to rebound of viral load was defined as time from the last dose (Day 8) to the time of the first occasion at which the viral load was greater than baseline value. Number of participants with rebound of viral load at specified number of days after last dose (day 8) was reported.|Day 8 up to Follow-up (Day 38 to 40 [31 to 33 days post-last dose])|Per protocol pharmacodynamic analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-dose viral load measurement.||participants|||Number
724902|NCT00348673|Primary|Change From Baseline in Human Immunodeficiency Virus-1 (HIV-1) Viral Load at Day 8|Change from baseline in log 10-transformed plasma viral load(Human Immunodeficiency Virus-1 Ribonucleic Acid[HIV-1 RNA]) levels(log10 copies/milliliter[copies/mL])reported.Viral load determined using reverse transcriptase-polymerase chain reaction(RT-PCR) assay with standard lower limit of detection(LLOD) 400 copies/mL.For samples with reading less than (<)400 copies/mL,assay repeated using ultra sensitive method with LLOD of 50 copies/mL.Values below limit of quantification(LOQ) 50 copies/mL set to 50 copies/mL.Baseline was mean of three pre-dose values taken at screening,randomization,Day 1.|Baseline, Day 8|Per protocol pharmacodynamic analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-dose viral load measurement.||log10 copies/mL||Standard Deviation|Mean
724903|NCT00348686|Secondary|Percent Change of proBNP(B Type Natriuretic Peptides) in Patients With Candesartan Plus Felodipine|Percent change of proBNP(B type Natriuretic Peptides) was calculated and collected through the way of Last Observational carried forward.|At Baseline and 24 weeks|Only 91 patients are available for analysis||percent change||Full Range|Median
724904|NCT00348686|Secondary|Percent Change of proBNP(B Type Natriuretic Peptides) in Patients Treated With Candesartan Only|Percent change of proBNP(B type Natriuretic Peptides) was calculated and collected through the way of Last Observational carried forward.|At Baseline and 24 weeks|Only 201 patients are available for analysis.||percent change||Full Range|Median
724911|NCT00348790|Other Pre-specified|To Use the FACT BR Questionnaire to Measure Quality of Life|FACT BR questionnaire will be used to measure quality of life at baseline and then every time an MRI scan is performed while on study treatment|At baseline and then every time an MRI is performed while on study treatment.||||||
724912|NCT00348790|Other Pre-specified|Develop Data Concerning Certain Genes That Cause Tumors to Grow New Blood Vessels|Data concerning certain genes that cause tumors to grow new blood vessels will be examined by MRI scan with MR Perfusion done before treatment and then every 2 months while on study treatment|MRI with MR Perfusion will be done before treatment and then every 2 months while on study treatment||||||
724913|NCT00348790|Secondary|To Correlate the Response Rates With Expression of Certain Types of Genes|Correlation of response rates with the expression of certain types of genes will be assessed by examining tissue samples taken from previous surgery and testing for certain genes|At the end of study treatment||||||
724914|NCT00348790|Secondary|To Describe the Response Rate and Overall Survival in This Patient Population|Response rate and overall survival will be assessed by MRI scan every 2 months while on study treatment and follow-up will be done at regularly scheduled office visits up to 1 year after discontinuation of study treatment.|Every 2 months for up to 1 year after study treatment||||||
724915|NCT00348790|Secondary|Determine Efficacy (Radiographic and Clinical Improvement)|Efficacy will be assessed by MRI scan and neurological exam upon study entry, every 2 weeks for 2 months, then every 8 weeks while on treatment|At baseline, every 2 weeks for 2 months, then every 8 weeks while on treatment||||||
724916|NCT00348790|Primary|Number of Patients Who DID NOT Experience Disease Progression or Death by 6 Months After Starting Treatment.|Patients were assessed with imaging techniques (MRI) during screening/baseline and then every 2 months after starting treatment. Survival status and disease status were recorded. The number of patients who did not experience an event (defined as either death for any reason or progression of their disease) by 6 months after starting treatment were counted.|From the date the first patient began treatment until the date the last patient has disease progression, becomes deceased, or completes 6 months of treatment|||participants|||Number
724917|NCT00348816|Secondary|Correlation Between Velocity of Subsequent PSA Failure and Survival||5 years||||||
724918|NCT00348816|Secondary|Overall Survival||5 years||||||
724919|NCT00348816|Secondary|Progression-free Survival Based on PSA Progression|Subjects were monitored for PSA (Prostate Specific Antigen) for up to 5 years of follow-up.|5 years|One subject was not included in analysis due to taken off study due to non-compliance||Participants|||Count of Participants
724920|NCT00348816|Primary|Rate of Prostate-Specific Antigen (PSA) Decline Reported as the Number of Subjects Reaching a PSA Nadir of Zero Following the Intervention.|Subjects were followed after the intervention and monitored for PSA (Prostate Specific Antigen) decline for up to 5 years of follow-up, to determine how many had a decline and reached a PSA nadir of zero..|5 years|Exceptions to group description: (1) one subject non-compliant and taken off study (not included in analysis); (2) one subject did not receive docetaxel #7 during radiation due to change in performance status; (3) one subject received only 1 post radiation docetaxel; (4) two subjects did not receive post radiation docetaxel #4.||Participants|||Count of Participants
724921|NCT00348881|Secondary|Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV|"Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions; Fever (temperature), Vomiting, Abnormal Crying, Drowsiness, Loss of Appetite, and irritability.
Grade 3 reactions are defined as: Pain - cries when injected limb is moved; Erythema and Swelling - ≥ 5cm; Fever - rectal temperature ≥ 39.6ºC; Vomiting - ≥6 episodes per 24 hours; Crying - inconsolable crying for >3 hours; Somnolence - sleeping most of the time or difficulty to wake up; Anorexia - refuses ≥3 feeds; and Irritability - inconsolable."|Day 0 to Day 7 after vaccination|Safety was assessed on the safety analysis (intent-to-treat) population. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The data were analyzed and presented according to the actual treatment received.||Participants|||Number
724922|NCT00348881|Primary|Number of Participants With Observed High Fever During the 7-Day After Vaccination With DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/ Hib™ Concomitantly With OPV.|Occurence of at least one high fever episode (≥ 39.6ºC rectal temperature equivalent) observed within 7 days after any of the three injections.|Day 0 to Day 7 post-vaccination|Safety was assessed on the safety analysis (intent-to-treat) population. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The data were analyzed and presented according to the actual treatment received and with the total number (N) available for the endpoint at each time-point.||Participants|||Number
724923|NCT00348881|Secondary|Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV|Immunogenicity was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-PRP antibodies; enzyme immunoassay (EIA) for anti-Tetanus; serum neutralization (SN) for anti-Diphtheria; and enzyme-linked immunosorbent assay (ELISA) for anti-Pertusiss (PT) and anti-Filamentous Hemagglutinin (FHA) titers at Day 150, 1 month after the third vaccination.|1 month post third vaccination|GMTs were assessed in a subset of the participants available for the endpoint, the per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
724924|NCT00348881|Primary|Number of Participants With Seroprotection for Anti-Hep Bs, Anti-PRP, Anti-Tetanus, and Anti-Diphtheria Antibodies After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV|"Seroprotection was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-PRP antibodies, enzyme immunoassay (EIA) for anti-Tetanus, and serum neutralization (SN) for anti-Diphtheria.
Seroprotection was defined as titers ≥ 10 mIU/mL for anti-Hep Bs; ≥ 0.15 μg/mL for anti-PRP; ≥ 0.01 IU/mL for anti-Tetanus and anti-Diphtheria at 30 days after the third vaccination."|1 month post third vaccination|Seroprotection was assessed in a subset of participants available for the endpoint, the per-protocol population.||Participants|||Number
724925|NCT00348933|Secondary|Change in RBC Folate||Baseline, 1 year|Analysis per protocol||ng/mL||Standard Deviation|Mean
724926|NCT00348933|Secondary|Change in Levels of Betaine, Creatine, Dimethylglycine, Guanidinoacetate, Homocysteine, and Methionine.||Baseline, 1 year|analysis per protocol||mmol/L||Standard Deviation|Mean
724927|NCT00348933|Primary|Average Change in Functioning in Specific Areas of Development, Including Speech and Communications Skills, Cognitive Abilities and Daily Living Skills|"Primary:
Bayley Scales of Infant Development measures Mental Developmental Index standard scores 0 (least skilled) - 100 (most skilled) Psychomotor Developmental Index standard scores 0 (least skilled - 10 (most skilled) Vineland Adaptive Behavior Scales (VABS), Communication standard scores 0 (least skilled) - 100 (most skilled) Daily Living Skills standard scores 0 (least skilled) - 100 (most skilled) Socialization standard scores 0 (least skilled) - 100 (most skilled) Motor Skills standard scores 0 (least skilled) - 100 (most skilled) Preschool Language Scale (PLS), Auditory Comprehension 0 (least skilled) - 100 (most skilled) Expressive Communication 0 (least skilled) - 100 (most skilled)"|Baseline, 1 year|Analysis per protocol||units on a scale||Standard Deviation|Mean
724928|NCT00349336|Secondary|Terminal Half-life of Bevacizumab|Terminal half-life (t1/2) (apparent elimination half-life). Estimation of the parameter was performed using non-compartmental methods.|Up to 48 weeks|42 patients participated in pharmacokinetic (PK) assessments and of those, 37 were included in the PK analysis. Two patients receiving XELOX+BV were not included in the PK analysis due to protocol violations.||hr||Standard Deviation|Mean
724929|NCT00349336|Secondary|Volume of Distribution of Bevacizumab at Steady State|Volume of distribution at steady state (Vss). Estimation of the parameter was performed using non-compartmental methods.|Up to 48 weeks|42 patients participated in pharmacokinetic (PK) assessments and of those, 37 were included in the PK analysis. Two patients receiving XELOX+BV were not included in the PK analysis due to protocol violations.||L||Standard Deviation|Mean
724930|NCT00349336|Secondary|Time of Maximum Serum Concentration of Bevacizumab|Time of maximum serum concentration (tmax). Estimation of the parameter was performed using non-compartmental methods.|Up to 48 weeks|42 patients participated in pharmacokinetic (PK) assessments and of those, 37 were included in the PK analysis. Two patients receiving XELOX+BV were not included in the PK analysis due to protocol violations.||hr||Standard Deviation|Mean
724931|NCT00349336|Secondary|Serum Clearance of Bevacizumab|Serum clearance (CL). Estimation of the parameter was performed using non-compartmental methods.|Up to 48 weeks|42 patients participated in pharmacokinetic (PK) assessments and of those, 37 were included in the PK analysis. Two patients receiving XELOX+BV were not included in the PK analysis due to protocol violations.||L/day||Standard Deviation|Mean
724932|NCT00349336|Secondary|Minimum Serum Concentration of Bevacizumab at Steady State|Minimum serum concentration at steady state (Css, min). Estimation of the parameter was performed using non-compartmental methods.|Up to 48 weeks|42 patients participated in pharmacokinetic (PK) assessments and of those, 37 were included in the PK analysis. Two patients receiving XELOX+BV were not included in the PK analysis due to protocol violations.||ug/ml||Standard Deviation|Mean
724933|NCT00349336|Secondary|Maximum Serum Concentration of Bevacizumab at Steady State|Maximum serum concentration at steady state (Css,max). Estimation of the parameter was performed using non-compartmental methods.|Up to 48 weeks|42 patients participated in pharmacokinetic (PK) assessments and of those, 37 were included in the PK analysis. Two patients receiving XELOX+BV were not included in the PK analysis due to protocol violations.||ug/mL||Standard Deviation|Mean
724934|NCT00349336|Secondary|Steady-state Exposure of Bevacizumab From Time Zero to Tau|Area under the serum concentration-time curve from time zero to tau, at steady state (AUCss 0-tau), where tau was the length of the cycle, i.e., tau = 3 weeks for XELOX+BV and tau = 2 weeks for FOLFOX-4+BEV. Estimation of the parameter was performed using non-compartmental methods.|Up to 48 weeks|42 patients participated in pharmacokinetic (PK) assessments and of those, 37 were included in the PK analysis. Two patients receiving XELOX+BV were not included in the PK analysis due to protocol violations.||day*ug/mL||Standard Deviation|Mean
724935|NCT00349336|Primary|Weekly Steady-state Exposure of Bevacizumab|Area under the serum concentration-time curve per week, at steady state (AUCss per week). Estimation of the parameter was performed using non-compartmental methods.|Up to 48 weeks|42 patients participated in pharmacokinetic (PK) assessments and of those, 37 were included in the PK analysis. Two patients receiving XELOX+BV were not included in the PK analysis due to protocol violations.||day*ug/mL||Standard Deviation|Mean
724936|NCT00349336|Secondary|Time Zero to Last Measurable Plasma Concentration of Bevacizumab|Area under the serum concentration-time curve from time zero to the time of the last measurable plasma concentration (AUC 0-last). Estimation of the parameter was performed using non-compartmental methods.|Up to 48 weeks|42 patients participated in pharmacokinetic (PK) assessments and of those, 37 were included in the PK analysis. Two patients receiving XELOX+BV were not included in the PK analysis due to protocol violations.||day*ug/mL||Standard Deviation|Mean
724937|NCT00349349|Secondary|Volume of Distribution at Steady State (Vss) at Dose 8 (Visit 9, Week 7) and at Dose 12 (Visit 14, Week 24)|Vss is defined as the volume of distribution at steady state of ofatumumab.|Visit 9 (Week 7) and Visit 14 (Week 24)|FAS. Data were provided for the number of participants attending each visit for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed.||Liters (L)||Geometric Coefficient of Variation|Geometric Mean
724938|NCT00349349|Secondary|Clearance (CL) After Dose 8 (Visit 9, Week 7) and Dose 12 (Visit 14, Week 24)|CL is the clearance of drug from serum, which is defined as the volume of serum from which the drug is cleared per unit time.|Visit 9 (Week 7) and Visit 14 (Week 24)|FAS. Data were provided for the number of participants attending each visit for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed.||Milliliters per hour (mL/h)||Geometric Coefficient of Variation|Geometric Mean
724939|NCT00349349|Secondary|Half-life (t1/2) at Dose 8 (Visit 9, Week 7) and at Dose 12 (Visit 14, Week 24)|Half-life ( t1/2) is defined as the terminal half-life and is the time required for the amount of drug in the body to decrease by half.|Visit 9 (Week 7) and Visit14 (Week 24)|FAS. Data were provided for the number of participants attending each visit for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed.||hours||Geometric Coefficient of Variation|Geometric Mean
724940|NCT00349349|Secondary|AUC (0-inf) and AUC(0-tau) at Dose 8 (Visit 9, Week 7) and Dose 12 (Visit 14, Week 24)|AUC is defined as the area under the ofatumumab concentration-time curve as a measure of drug exposure. AUC(0-inf) is AUC from the start of infusion extrapolated to infinity. AUC(0-tau) is AUC from the start of infusion over the dosing interval.|Visit 9 (Week 7) and Visit 14 (Week 24)|FAS. Data were provided for the number of participants attending each visit for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed.||Milligrams x hour per liter (mg.h/L)||Geometric Coefficient of Variation|Geometric Mean
724941|NCT00349349|Secondary|Cmax and Ctrough at Dose 1 (Visit 2, Week 0), Dose 8 (Visit 9, Week 7), and Dose 12 (Visit 14, Week 24)|Cmax is defined as the maximum concentration of drug in serum samples. Ctrough is defined as the trough serum concentration (measured concentration at the end of a dosing interval [taken directly before the next administration]). No drug was present before the first infusion; therefore, there are no Ctrough results for Dose 1|Visit 2 (Week 0), Visit 9 (Week 7), and Visit 14 (Week 24)|FAS. Data were provided for the number of participants attending each visit. Participants withdrawn during the study were not analyzed.||Milligrams per liter (mg/L)||Geometric Coefficient of Variation|Geometric Mean
724942|NCT00349349|Secondary|Number of Participants Who Experienced Any Adverse Event|An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with the treatment. A list of AEs experienced in the study with a frequency threshold of 5% can be found in the AE section of this results record.|From first infusion (Visit 2/Week 0) to Visit 21 (Month 24 of follow-up [up to Month 48]) or time of withdrawal (treatment and follow-up)|FAS||participants|||Number
724943|NCT00349349|Secondary|Number of Participants With Complete Resolution of Splenomegaly|Participants with complete resolution of enlarged spleen (splenomegaly) were defined as those with an enlarged palpable spleen at baseline followed by the absence of splenomegaly post-baseline (i.e., the spleen was of normal size). Spleen size was assessed by physical examination and documented as “centimeters” under the costal margin with relative changes in spleen size in 1 dimension calculated based on palpated numeric measurements (as per the 1996 NCIWG guidelines).|Baseline (Visit 2) until Week 24|FAS. Data were provided for the number of participants with splenomegaly at baseline attending each visit. Participants withdrawn during the study were not analyzed. Only participants with baseline splenomegaly and a post-baseline assessment are included.||participants|||Number
724944|NCT00349349|Secondary|Number of Participants With Improvement in Neutropenia|Low levels of neutrophils (neutropenia) may increase the risk of developing serious infections and may be considered an adverse condition and evaluated on the NCI CTC with a grade. Improvement in neutropenia is defined as a decrease from Visit 2 (baseline) by at least one NCI CTC grade. Improvement is defined as a decrease from Visit 2 by at least one NCI CTC grade.|Baseline (Visit 2) to Week 28|FAS. Only those par. remaining in the study at Week 28 were analyzed. No par. in the “Other” treatment arm met the criteria for analysis.||participants|||Number
724945|NCT00349349|Secondary|Number of Participants With Complete Resolution of Hepatomegaly|Participants with complete resolution of enlarged liver (hepatomegaly) were defined as those with an enlarged palpable liver at baseline followed by the absence of hepatomegaly post- baseline (i.e., the liver was of normal size). Liver size was assessed by physical examination and documented as “centimeters” under the costal margin with relative changes in spleen size in 1 dimension calculated based on palpated numeric measurements (as per the 1996 NCIWG guidelines).|Baseline (Visit 2) until Week 24|FAS. Data were provided for the number of participants with hepatomegaly from baseline attending each visit. Participants withdrawn during the study were not analyzed. Only participants with baseline hepatomegaly and a post-baseline assessment are included.||participants|||Number
724946|NCT00349349|Secondary|Number of Participants With Improvement in Thrombocytopenia (Thromb.)|Improvement in thromb. is defined as a decrease from Visit 2 by >=1 National Cancer Institute Common Terminology Criteria (NCI CTC) grade. Thromb. is defined as low platelet counts resulting from refractory CLL, damage from prior treatment, advanced age, or reduced bone marrow function and can be considered as an adverse condition. Adverse events (AEs) such as thromb. in a cancer indication are graded on a scale determined by the NCI called the NCI CTC: lowest, grade 1; highest, grade 5 (death). Changes in this grading can assess improvements or declines in the severity of the AE.|Baseline (Visit 2) to Week 28|FAS. Only those participants remaining in the study at Week 28 were analyzed. No par. in the “Other” treatment arm met the criteria for analysis.||participants|||Number
724947|NCT00349349|Secondary|Number of Participants With Improvement in Hemoglobin|The number of participants (par.) who had improvement in hemoglobin levels >=11 grams (g)/deciliter (dl) (6.8 millimoles/liter) or 50% improvement over baseline was measured.|Baseline (Visit 2) to Week 28|FAS. Par. were excluded from analysis if they received treatment of red blood cells (RBCs), received transfusions or a RBC growth factor (erythropoietin), died, withdrew from the trial, or began next CLL treatment. Only those par. remaining in the study at Week 28 were analyzed. No par. in the “Other” treatment arm met the criteria for analysis.||participants|||Number
724948|NCT00349349|Secondary|Number of Participants Who Were Positive, Negative, or Had Missing Data for the Indicated Fluorescence in Situ Hybridization (FISH) Prognostic Factors at Screening|The number of participants (par.) who were positive, negative, or had missing data for the following prognostic factors indicative of altered responsiveness to treatment and/or survival was measured: 17p-, 11q-, +12q, 6q-, 13q-. Par. were assessed by FISH for these chromosomal abnormalities known tobe prognostic for time to treatment and survival when detected at diagnosis. Par. were categorized by the chromosomal abnormality detected: 17 p deletion, 11q deletion (but not 17 p deletion), 12 q trisomy (but not 17 p or 111q deletion), 13q deletion only, and no chromosomal abnormalities found.|Screening (Visit 1, <=14 days prior to Visit 2)|FAS. Par. were categorized hierarchically (by severity of abnormality): par. with a 17 p deletion (D); par. with an 11q D, but not a 17 p D; par. with 12q trisomy, but not a 17p or 11q D; par. with no aberrations found; par. with a 13q D as the sole aberration; and par. with 6q D (and not any of the above categories). Some par. had missing data.||participants|||Number
724949|NCT00349349|Secondary|Number of Participants With Improvement on the Eastern Cooperative Oncology Group (ECOG) Performance Status Scale at Week 24|ECOG performance status is a measure of the participant’s ability to carry out activities of daily living on 6-point scale (0=fully active, 1=restricted in physically activity, ambulatory, 2=ambulatory [>50% of waking hours], 3=capable of only limited self care, 4=completely disabled, 5=Dead). Improvement in ECOG performance status is defined as a decrease from baseline by at least one score on the ECOG scale.|Baseline (Visit 2) and Week 24|FAS. Data were provided for participants (par.) with an ECOG score >0 at baseline attending each visit. Par. withdrawn from the study were not analyzed. (55 par. had an ECOG performance status of 0 at baseline and therefore did not have the opportunity to improve. No par. with an ECOG score of 0 at baseline worsened during the trial.)||participants|||Number
725148|NCT00351000|Primary|Change From Baseline on Fasting Insulin|Subjects on clozapine with adjunctive ziprasidone were compared to subjects on olanzapine with adjunctive ziprasidone on change in fasting insulin levels from baseline to study endpoint (week 6 - baseline)|baseline, week 6|||microIU/L||Standard Deviation|Mean
724950|NCT00349349|Secondary|Number of Participants With Complete Resolution of Lymphadenopathy|Participants with complete resolution of lymphadenopathy (disease involving the lymph nodes) were defined as those in whom all observed lymph nodes were of normal size (all nodes <1 centimeters) as determined by physical examination assessed by the investigator. All palpable lymph node sizes were recorded.|Baseline (Visit 2) to end of study (up to Week 24)|FAS. Data were provided for the number of participants with lymphadenopathy at baseline attending each visit. Participants withdrawn during the study were not analyzed. (Participants without baseline lymphadenopathy remained free of lymphadenopathy during the trial.)||participants|||Number
724951|NCT00349349|Secondary|Number of Participants With Complete Resolution of Constitutional Symptoms at Week 24|Participants with complete resolution of constitutional symptoms were those in whom no constitutional symptoms, such as night sweats, weight loss, and fever or extreme fatigue, were observed.|Baseline (Visit 2) and Week 24|FAS. Data were provided for the number of participants with constitutional symptoms at baseline attending each visit. Participants withdrawn during the study were not analyzed. (Participants without baseline constitutional symptoms did not experience new constitutional symptoms during the trial period.)||participants|||Number
724952|NCT00349349|Secondary|Median Percent Change of Tumor Size (Sum of Products Dimensions [SPD]) From Baseline (Visit 2) to Week 24 (Visit 14)|Tumor size and change in tumor size will be measured by the absolute value of and the percent change in the sum of products of the diameters of the largest abnormal lymph nodes from Baseline to Week 24 (Visit 14). Percent change from Visit 2 (Baseline, Week 0) = (value at Week 24 minus value at Week 0 divided by value at Week 0) x 100.|Baseline (Visit 2) until Week 24 (Visit 14)|FAS||percent change in tumor size||Full Range|Median
724953|NCT00349349|Secondary|Percent Change From Baseline to Week 7 in Peripheral CD5+CD20+ Cell Counts|The peripheral blood for each participant was collected and analyzed for CD5+CD20+ cell counts. CD is “cluster of differentiation,” is a cell surface marker for immunophenotyping, and, in this case, is a surrogate for B cell malignancy (indicates malignant B cells). Percent change from Visit 2 (Week 0, Baseline) = (value at Week 7 minus value at Week 0 divided by value at Week 0) x 100.|Baseline (Visit 2) until Week 7 (Visit 9)|FAS||percent change in cell counts||Full Range|Median
724954|NCT00349349|Secondary|Percent Change From Baseline to Week 7 in Peripheral CD5+CD19+ Cell Counts|The peripheral blood for each participant was collected and analyzed for CD5+CD19+ cell counts. CD is “cluster of differentiation,” is a cell surface marker for immunophenotyping, and, in this case, is a surrogate for B cell malignancy (indicates malignant B cells). Percent change from Visit 2 (Week 0, Baseline) = (value at Week 7 minus value at Week 0 divided by value at Week 0) x 100.|Baseline (Visit 2) until Week 7 (Visit 9)|FAS||percent change in cell counts||Full Range|Median
724955|NCT00349349|Secondary|Overall Survival|OS is defined as the time from allocation to death. OS will also be subgrouped for responders and non-responders.|Start of randomization (Week 0 of Visit 2) until death (up to a median of 17.1 weeks)|FAS||months||95% Confidence Interval|Median
724956|NCT00349349|Secondary|Time to Next Chronic Lymphocytic Leukemia (CLL) Treatment|Time to next chronic lymphocytic leukemia (CLL) treatment is defined as the time from treatment allocation/randomization (Visit 2) until the time of the first administration of the next CLL treatment other than ofatumumab (or HuMaxCD20, a fully human monoclonal antibody to CD20 that is expressed on the surface of B-cells).|Time from randomization (Week 0 of Visit 2) until the time of first administration of a CLL treatment other than ofatumumab (assessed for a median of 8.7 weeks currently [or up to 13.3 months])|FAS||months||95% Confidence Interval|Median
724957|NCT00349349|Secondary|Progression-Free Survival (PFS)|PFS is defined as the time from randomization until progression/death. Per the IRC, if the participant had progression between scheduled visits, died before the first assessment, or died between adequate visits, the endpoint was considered progressed. If there was no progression at the end of the trial, treatment discontinuation for undocumented progression, treatment discontinuation for toxicity/other reason, new anti-cancer treatment, and death/progression after 2 or more missed visits in a row, the endpoint was censored. Clinical progression is not considered as progression endpoint.|Start of treatment (Week 0 of Visit 2) until Week 24|FAS||months||95% Confidence Interval|Median
724958|NCT00349349|Secondary|Duration of Response|Duration of response is defined as the time from the initial response (first visit at which response is observed) to progression or death. If the participant had progression between scheduled visits, no progression at the end of the trial, treatment discontinuation for undocumented progression, treatment discontinuation for toxicity or other reason, new anti-cancer treatment, and experienced death or progression after two or more missed visits in a row the endpoint was censored.|Start of treatment (Week 0 of Visit 2) until Week 24|FAS||months||95% Confidence Interval|Median
724959|NCT00349349|Primary|Number of Participants (Par.) Classified as Responders and Non-responders for Objective Response as Assessed by an Independent Endpoint Review Committee (IRC) in Accordance With the National Cancer Institute Working Group (NCIWG) 1996 Guidelines|Par. with complete remission (CR), nodular partial remission (nPR), and partial remission (PR) were classified as responders, while those with stable disease (SD) and progressive disease (PD) were classified as non-responders. Per the NCIWG guideline (1996): CR; no lymphadenopathy/hepatomegaly/splenomegaly/constitutional symptoms, normal hematology, bone marrow sample as normocellular for age, <30% lymphocytes (LC), no lymphoid nodule; PR: a >=50% decrease in LC/lymphadenopathy; nPR: persistent nodules in bone marrow; PD: new lesion or increase by >=50% from baseline; SD: no CR, PR, or PD.|Start of treatment (Week 0 of Visit 2) until Week 24|Full Analysis Set (FAS): all participants who had been exposed to study drug irrespective of their compliance to the planned course of treatment. Participants not evaluable (NE) were due to patient withdraw, refusal, non-trial drug related AEs, and death||participants|||Number
724960|NCT00349388|Secondary|Improved Medication Compliance.|unable to measure since no one enrolled in second arm. Therefore, no comparisons can be made.|overall study||||||
724961|NCT00349388|Primary|Once Daily Dosing Works as Well a Multiple Dosing a Day.|subject tolerated once a day dose Only 1 subject enrolled which was the control arm standard dose twice a day. No subjects enrolled to take dose once a day Therefore, primary outcome cannot be reported|overall study|cannot analysze primary outcome because no subjects were enrolled in the once a day dose arm. Study was terminated due to lack of enrollment|||||
724962|NCT00349466|Secondary|Use of Artificial Tears|daily use of REFRESH TEARS® Lubricant Eye Drops artificial tears supplied to each patient was recorded in diaries provided to patients|12 weeks||||||
724966|NCT00349466|Primary|Fluorescein Staining of the Cornea|Severity of corneal epithelial loss as graded by Fluorescein Staining of the cornea, assessed on a 0-4+ scale with 0 = none and 4+ = severe de-epithelialization, expressed as number of participants with >25% improvement at Week 12 relative to baseline|Baseline and 12 weeks|Per protocol, observed values||Participants|||Number
724967|NCT00349466|Primary|Tear Break-Up Time|time elapsed between a complete blink and the development of the first random dry spot on the tear film|12 weeks||||||
724968|NCT00349466|Primary|Schirmer Test (ST)|involved placing a standardized paper tear strip inside the lower eyelid for 5 minutes. The tear strip was then removed and the length of the strip that was wet from tears was measured in millimeters|12 weeks||||||
724969|NCT00349622|Secondary|Change From Baseline in Evaluation of Multiple Lower Extremity Muscles Using Hand Held Dynamometry at One Year|"Hand-held Dynamometry (HHD) is used to evaluate muscle strength. Six proximal muscle groups were examined bilaterally in both upper and lower extremities (shoulder flexion, elbow flexion, elbow extension, hip flexion, knee flexion, and knee extension). In addition, wrist extension, first dorsal interosseous contraction and ankle dorsiflexion were measured bilaterally.
HHD analysis was performed using Percent Change from Baseline. Each subject’s baseline strength value for each muscle group is considered 100%. During successive visits strength for each muscle group was measured using HHD and was calculated as a percentage of the initial baseline value recorded. Upper extremity and lower extremity values were calculated as the sum of all tests for that extremity to create one megascore for upper and one megascore for lower extremity muscles.
This outcome measure calculation is based on measurements every 12 weeks from the Baseline Visit up until one year."|Every 12 weeks for one Year|||Percent change per 12 weeks||Standard Error|Mean
724970|NCT00349622|Secondary|Change From Baseline in the ALS-Specific Quality of Life Scale (ALSQOL) at One Year|"The ALS-Specific Quality of Life Scale (ALSQOL). was developed, tested, and validated in subjects with ALS, and is not a health-related quality of life scale. The scale consists of 59 questions that ask about severity of the symptoms of ALS, mood and affect, intimacy, and social issues. Each question for the ALSQOL is scored from 0-10. With 59 questions, total score ranges from 0-590 with scores simply added, with 590 representing highest quality of life. However since 10 is maximally weighted towards negative values on some questions and positive values on others, the following questions must have results transposed (Simply reverse the scale, for instance 10=0 and 0=10) prior to analysis: 1-10, 11, 16, 19, 24, 26, 28, 32, 35, 36, 38, and 41. Optional items are 50, 53, 56, and 59. These questions are not included on any scale or in any quantitative analyses.
This outcome measure calculation is based on measurements every 12 weeks from the Baseline Visit up until one year."|Every 12 weeks for one Year|||units on a scale per 12 weeks||Standard Error|Mean
724971|NCT00349622|Secondary|Change From Baseline in Evaluation of Multiple Upper Extremity Muscles Using Hand Held Dynamometry at One Year|"Hand-held Dynamometry (HHD) is used to evaluate muscle strength. Six proximal muscle groups were examined bilaterally in both upper and lower extremities (shoulder flexion, elbow flexion, elbow extension, hip flexion, knee flexion, and knee extension). In addition, wrist extension, first dorsal interosseous contraction and ankle dorsiflexion were measured bilaterally.
HHD analysis was performed using Percent Change from Baseline. Each subject’s baseline strength value for each muscle group is considered 100%. During successive visits strength for each muscle group was measured using HHD and was calculated as a percentage of the initial baseline value recorded. Upper extremity and lower extremity values were calculated as the sum of all tests for that extremity to create one megascore for upper and one megascore for lower extremity muscles.
This outcome measure calculation is based on measurements every 12 weeks from the Baseline Visit up until one year."|Every 12 weeks for one Year|||Percent change per 12 weeks||Standard Error|Mean
724972|NCT00349622|Secondary|Change in % Vital Capacity From Screening to One Year|"Vital Capacity is measured as the percent predicted per subject based on age, gender, and height, and is performed as a Slow Vital Capacity.
This outcome measure calculation is based on measurements every 12 weeks from the Baseline Visit up until one year."|Every 12 weeks for one Year|||percent change in VC per 12 weeks||Standard Error|Mean
724973|NCT00349622|Primary|Change From Baseline in ALS Functional Rating Scale, Revised (ALSFRS-R) at One Year|"Amyotrophic Lateral Sclerosis Functional Rating Scale, Revised (ALSFRS-R) is a quickly administered (five minute) ordinal rating scale used to determine patients' assessment of their capability and independence in 12 functional activities/questions. The 12 functional activities/questions are rated on a scale of 0 to 4 for a total scoring range of 0-48, with 48 representing optimal function. All 12 activities are relevant in ALS.
This outcome measure calculation is based on measurements every 8 weeks from the Baseline Visit up until one year."|Every 8 weeks for one year|||units on a scale per 8 weeks||Standard Error|Mean
724974|NCT00349622|Primary|Survival|Survival is presented as median day of survival for each group. Survival is defined as time to death, tracheostomy or the initiation of permanent assisted ventilation (PAV).|From date of randomization until date of death, tracheostomy, or the initiation of permanent assisted ventilation (PAV). This was assessed at time of each participant's drug discontinuation and every 2 months thereafter for the life of the study (6 yrs)|||days||95% Confidence Interval|Median
724975|NCT00349713|Secondary|Subjects With 2- and 4-fold Increases in Anti-FMP2.1 Antibody Levels Over Time|Proportion of Subjects with 2- and 4-fold increases in Anti-FMP2.1 Antibody levels on days 14, 30, 44, 60, 74 and 90|90 Days|||number of participants with increase|||Number
724976|NCT00349713|Secondary|Geometric Mean Antibody Titers Over Time|Measurement of geometric mean antibody titers on days 0, 14, 30, 44, 60, 74 and 90|90 Days|||Geometric Mean of Antibody Titers||95% Confidence Interval|Geometric Mean
724977|NCT00349713|Secondary|Anti-AMA1 Log Antibody Titers Over Time|Summary of Anti-AMA1 Log Antibody titers on days 0, 14, 30, 44, 60, 74 and 90|90 Days|||log antibody titers||Standard Deviation|Mean
724978|NCT00349713|Secondary|Antibody Response to FMP2.1 Over Time|Measurement of anti-AMA1 antibody titers over time|90 Days|Anti-AMA1 Antibody titers on days, 0, 14, 30, 44, 60, 74, and 90||Antibody Titers||Standard Deviation|Mean
724979|NCT00349713|Primary|Safety and Reactogenicity (SAEs and AEs)|The primary objective was to evaluate the safety and reactogenicity of 2 dose levels of WRAIR's AMA1 malaria antigen (FMP2.1) adjuvanted in GlaxoSmithKline Biologicals' (GSK) AS02A compared to rabies vaccine in malaria-experienced Malian adults aged 18-55 years inclusive. Solicated AEs were recorded for the 7 day surveillance period after each vaccination. Unsolicited AEs were recorded for 30 days after each vaccination.|12 months|Summary of Adverse Events by Group and Immunization Group||Number of events|||Number
724980|NCT00349752|Secondary|Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 38|The total IBDQ score will be derived as the sum of the responses (each ranging from 1 to 7) to all 32 questions on the IBDQ and can therefore range from 32 to 224. A higher scores indicates a better quality of life. IBDQ response is defined as an increase from baseline in the IBDQ total score >= 16 points.|Week 0, Week 38|Of the 87 (Placebo) and 87 (Certolizumab Pegol 400 mg) subjects randomized, 23 and 26 subjects respectively had available values at Baseline and Week 38 and are included in the summary based on the intention-to-treat (ITT) population.||score on a scale||Standard Deviation|Mean
724981|NCT00349752|Secondary|Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 38|The total IBDQ score will be derived as the sum of the responses (each ranging from 1 to 7) to all 32 questions on the IBDQ and can therefore range from 32 to 224. A higher score indicates a better quality of life. IBDQ remission is defined as a subject having an IBDQ total score >= 170 points.|Week 38|Of the 87 (Placebo) and 87 (Certolizumab pegol 400 mg) subjects randomized, 23 and 27 subjects respectively had available values at Week 38 and are included in the summary based on the intention-to-treat (ITT) population.||score on a scale||Standard Deviation|Mean
724982|NCT00349752|Secondary|Change From Baseline in CDAI Score at Week 38|The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0, Week 38|Of the 87 (Placebo) and 87 (Certolizumab pegol 400 mg) subjects randomized, 22 and 27 subjects respectively had available values at Baseline and at Week 38 and are included in the summary based on the intention-to-treat (ITT) population.||score on a scale||Standard Deviation|Mean
724983|NCT00349752|Secondary|Crohn's Disease Activity Index (CDAI) Score at Week 38|The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 38|Of the 87 (Placebo) and 87 (Certolizumab pegol 400 mg) subjects randomized, 22 and 27 subjects respectively are included in the summary of the Week 38, based on the intention-to-treat (ITT) population.||score on a scale||Standard Deviation|Mean
724984|NCT00349752|Secondary|Change From the 6-week run-in Period in Per-subject Median Weekly Dose of Corticosteroids Over the 38-week Double-blind Treatment Period|The run in period lasted a minimum of 1 week and a maximum of 6 weeks. During this period subjects were treated with any dose or type of systemic corticosteroids the Investigator felt was appropriate. To be eligible for study randomization, subjects must have been in remission (CDAI ≤150 points) and receiving corticosteroids at a dose no higher than 30 mg/day prednisone or equivalent during the week prior to randomization. Subjects who did not meet these criteria were not randomized and were withdrawn from the study.|6-week run-in period, 38-week double-blind treatment period|Of the 87 (Placebo) and 87 (Certolizumab pegol 400 mg) subjects randomized, 86 in each group had available values at the 6-week run-in period and over the 38-week double-blind treatment period.||mg per week||Standard Deviation|Mean
724985|NCT00349752|Secondary|Per-subject Cumulative Dose of Corticosteroids Over the 48-week Study Period|The cumulative dose of corticosteroids over the 48-week study period is calculated for each subject individually. The mean of these values for each treatment group is presented here.|Over the 48-week study period|87 (Placebo) and 87 (Certolizumab pegol 400 mg) subjects randomized are included in the summary based on the intention-to-treat (ITT) population. Of the 87 subjects in the placebo group, 1 subject taking a daily dose of 3g with a rectal route has been excluded from the analysis.||mg||Standard Deviation|Mean
724986|NCT00349752|Secondary|Per-subject Median Weekly Dose of Corticosteroids Over the 38-week Double-blind Treatment Period|The median weekly dose of corticosteroids is calculated for each subject, and these per-subject median values are further summarized by treatment group. The mean of the per-subject median doses in each treatment group is presented here.|Over the 38-week double-blind treatment period|87 (Placebo) and 87 (Certolizumab pegol 400 mg) subjects randomized are included in the summary based on the intention-to-treat (ITT) population. Of the 87 subjects in the placebo group, 1 subject taking a daily dose of 3g with a rectal route has been excluded from the analysis.||mg per week||Standard Deviation|Mean
724987|NCT00349752|Secondary|Time to Relapse/Treatment Failure During the 38-week Double-blind Treatment Period|A subject with relapse/ treatment failure has a Crohn's Disease Activity Index (CDAI) > 150 and an increase in CDAI of >= 70 points versus Week 0. [The CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease.]|During the 38-week double-blind treatment period|Of 87 (Placebo) and 87 (Certolizumab pegol 400 mg) subjects randomized, 85 and 87 subjects respectively are included in summary of Week 38, based on conditional intention-to-treat population, consisting of all randomized subjects who received at least one injection of study medication, excluding those who were not in remission (CDAI>150) at Week 0||days||Standard Deviation|Mean
724988|NCT00349752|Secondary|Cumulative Percentage of Subjects With Relapse/Treatment Failure at Week 38|A subject with relapse/ treatment failure has a Crohn's Disease Activity Index (CDAI) > 150 and an increase in CDAI of >= 70 points versus Week 0. [The CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease.]|Week 38|Of 87 (Placebo) and 87 (Certolizumab pegol 400 mg) subjects randomized, 85 and 87 subjects respectively are included in summary of Week 38, based on conditional intention-to-treat population, consisting of all randomized subjects who received at least one injection of study medication, excluding those who were not in remission (CDAI>150) at Week 0||percentage of subjects|||Number
724989|NCT00349752|Secondary|Percentage of Subjects With Continuous Remission Off Steroids at Week 38|The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease. A subject with continuous remission off steroids at Week 38 is a subject in remission (CDAI =< 150) from the visit when he stops taking steroids to Week 38 and is off corticosteroids until Week 38.|Week 38|Intention-to-treat (ITT) population which consists of all randomized subjects who received at least one injection of study medication. In the analyses of remission rates, subjects for whom it is impossible to assess the remission status will be conservatively considered as non-remitters in the calculations.||percentage of subjects|||Number
724990|NCT00349752|Primary|Percentage of Subjects Who Have Been Withdrawn From Prednisone or Prednisolone Therapy According to the Corticosteroid Tapering Schedule and Have Remained Off Corticosteroids and in Disease Remission at Week 38|The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease.|Week 38|Intention-to-treat (ITT) population which consists of all randomized subjects who received at least one injection of study medication. In the analyses of remission rates, subjects for whom it is impossible to assess the remission status will be conservatively considered as non-remitters in the calculations.||percentage of subjects|||Number
724991|NCT00349908|Primary|Technical Feasibility- Percent Stenosis (Post Procedure)|Percent Stenosis assessed immediately post procedure from pre procedure|Post Procedure|Group 2 - Aneurysm Arm not analyzed for stenosis. Stenosis only relevant in Atherosclerosis treatment.||Percentage Change from PreProcedure||Standard Deviation|Mean
724992|NCT00349908|Primary|Technical Feasibility- Percent Stenosis (6 mo Post Procedure)|Percent Stenosis assessed 6 mo Post Procedure from pre-procedure|6 mo|Group 2 - Aneurysm Arm not analyzed for stenosis. Stenosis only relevant in Atherosclerosis treatment.||Percentage change from PreProcedure||Standard Deviation|Mean
724993|NCT00349908|Primary|Technical Feasibility- Successful Stent/Coil Placement (6 Mo Post Procedure)|Successful stent/coil placement assessed at 6 mo post|6 mo|||Percentage of stable stent/coil placemen|||Number
724994|NCT00349908|Primary|Technical Feasibility- Percent Occlusion (6 Mo Post Procedure)|6 Months post|6 mo|Group 1 - Atherosclerosis Arm not analyzed for occlusion. Occlusion only relevant in Aneurysm treatment.||percent occlusion||Full Range|Mean
724995|NCT00349908|Primary|Technical Feasibility- Percent Occlusion (Post Procedure)|Occlusion evaluated immediately post procedure|post procedure|Group 1 - Atherosclerosis Arm not analyzed for occlusion. Occlusion only relevant in Aneurysm treatment.||percent occlusion||Full Range|Mean
724996|NCT00349908|Secondary|The Secondary Outcome Measure in Group 1, Atherosclerosis and in Group 2, Aneurysm, is the Evaluation of Adverse Events. The Groups Were Analyzed Separately.|An adverse event was defined as any untoward medical occurrence in a subject.|6 months|Group 1 and Group 2 were analyzed separately. In group 1 Atherosclerosis, 25 unique adverse events were reported in 8 of the 10 eligible subjects. In group 2 aneurysm, 28 unique adverse events were reported in 9 of the 10 eligible subjects.||Number of adverse events|||Number
724997|NCT00349908|Primary|Technical Feasibility- Successful Stent/Coil Placement (Post Procedure)|Successful placement of the product assessed immediately post procedure|post procedure|||percentage of stable placement|||Number
724998|NCT00349921|Primary|Number Meeting Success Criterion|Verbal pain report 2 hours post injection compared to baseline verbal pain scores prior to injection|baseline and 2 hours|The primary outcome measure will be % change in pain report 2 hr following injection, using a response criterion of 30% reduction in ongoing pain.||participants meeting success criterion|||Number
724999|NCT00350025|Secondary|Response Rate, Duration of Response, Time to Progression Will be Assessed With Radiographic Imaging||Measured by CT scans after every 2 cycles of treatment (about every 8 weeks)|Overall Survival||weeks||95% Confidence Interval|Median
725000|NCT00350025|Primary|Progression Free Survival||Measures by CT scans following each 2 cycles of treatment and about every 8 weeks after off treatment for disease progression. Follow up for survival until time of death.|||weeks||95% Confidence Interval|Median
725001|NCT00350142|Secondary|Median Overall Survival Time|The survival time for each patient is measured as the number of months from randomization until the time of death from any cause. The median survival time is computed using Kaplan Meier curves.|up to 3 years|||months||Full Range|Median
725002|NCT00350142|Primary|Rate of Local Control|"The proportion of patients with local control where local control is defined as no recurrence or disease progression in the primary disease site.
Disease progression was defined using either the RECIST or Pet criteria. Using the RECIST criteria disease progression is defined as a more than 25% tumor increase by volume and/ or presence of a new lesion. Using the Pet criteria disease progression is defined as an increase in PET activity as compared to the scan used in the planning of the treatment; any subsequent increase in SUVmax was defined as local progression."|up to 3 years|||participants|||Number
725003|NCT00350207|Secondary|Mean PEF Variability at Week 16|PEF (Peak expiratory flow) variability is defined as the difference between the highest morning PEF value and the highest evening PEF value of one day divided by the arithmetic mean of these two PEF values and multiplied by 100%|After 16 weeks of treatment|FAS||ratio expressed in percent||Standard Error|Least Squares Mean
725004|NCT00350207|Secondary|Mean PEF Variability at Week 12|PEF (Peak expiratory flow) variability is defined as the difference between the highest morning PEF value and the highest evening PEF value of one day divided by the arithmetic mean of these two PEF values and multiplied by 100%|After 12 weeks of treatment|FAS||ratio expressed in percent||Standard Error|Least Squares Mean
725005|NCT00350207|Secondary|Mean PEF Variability at Week 8|PEF (Peak expiratory flow) variability is defined as the difference between the highest morning PEF value and the highest evening PEF value of one day divided by the arithmetic mean of these two PEF values and multiplied by 100%|After 8 weeks of treatment|FAS||ratio expressed in percent||Standard Error|Least Squares Mean
725006|NCT00350207|Secondary|Mean PEF Variability at Week 4|PEF (Peak expiratory flow) variability is defined as the difference between the highest morning PEF value and the highest evening PEF value of one day divided by the arithmetic mean of these two PEF values and multiplied by 100%|After 4 weeks of treatment|FAS||ratio expressed in percent||Standard Error|Least Squares Mean
725007|NCT00350207|Secondary|Pulse Rate in Conjunction With Spirometry at Visit 5|Pulse rate collected in conjunction with spirometry at 16 weeks|After 16 weeks of treatment|Treated set. Some patients discontinued the trial between Visits. Thus these patients are in the efficacy analysis for the respective period (are added in the participant flow) but they have no safety blood pressure/pulse rate measurements, because blood pressure and pulse rate were measured at Visits||bpm||Standard Deviation|Mean
725008|NCT00350207|Secondary|Pulse Rate in Conjunction With Spirometry at Visit 4|Pulse rate collected in conjunction with spirometry at 12 weeks|After 12 weeks of treatment|Treated set. Some patients discontinued the trial between Visits. Thus these patients are in the efficacy analysis for the respective period (are added in the participant flow) but they have no safety blood pressure/pulse rate measurements, because blood pressure and pulse rate were measured at Visits||bpm||Standard Deviation|Mean
725009|NCT00350207|Secondary|Pulse Rate in Conjunction With Spirometry at Visit 3|Pulse rate collected in conjunction with spirometry at 6 weeks|After 6 weeks of treatment|Treated set. Some patients discontinued the trial between Visits. Thus these patients are in the efficacy analysis for the respective period (are added in the participant flow) but they have no safety blood pressure/pulse rate measurements, because blood pressure and pulse rate were measured at Visits||bpm||Standard Deviation|Mean
725010|NCT00350207|Secondary|Diastolic Blood Pressure in Conjunction With Spirometry at Visit 5|Diastolic blood pressure collected in conjunction with spirometry at 16 weeks|After 16 weeks of treatment|Treated set. Some patients discontinued the trial between Visits. Thus these patients are in the efficacy analysis for the respective period (are added in the participant flow) but they have no safety blood pressure/pulse rate measurements, because blood pressure and pulse rate were measured at Visits||mmHg||Standard Deviation|Mean
725011|NCT00350207|Secondary|Diastolic Blood Pressure in Conjunction With Spirometry at Visit 4|Diastolic blood pressure collected in conjunction with spirometry at 12 weeks|After 12 weeks of treatment|Treated set. Some patients discontinued the trial between Visits. Thus these patients are in the efficacy analysis for the respective period (are added in the participant flow) but they have no safety blood pressure/pulse rate measurements, because blood pressure and pulse rate were measured at Visits||mmHg||Standard Deviation|Mean
725012|NCT00350207|Secondary|Diastolic Blood Pressure in Conjunction With Spirometry at Visit 3|Diastolic blood pressure collected in conjunction with spirometry at 6 weeks|After 6 weeks of treatment|Treated set. Some patients discontinued the trial between Visits. Thus these patients are in the efficacy analysis for the respective period (are added in the participant flow) but they have no safety blood pressure/pulse rate measurements, because blood pressure and pulse rate were measured at Visits||mmHg||Standard Deviation|Mean
725013|NCT00350207|Secondary|Systolic Blood Pressure in Conjunction With Spirometry at Visit 5|Systolic blood pressure collected in conjunction with spirometry at 16 weeks|After 16 weeks of treatment|Treated set. Some patients discontinued the trial between Visits. Thus these patients are in the efficacy analysis for the respective period (are added in the participant flow) but they have no safety blood pressure/pulse rate measurements, because blood pressure and pulse rate were measured at Visits||mmHg||Standard Deviation|Mean
725014|NCT00350207|Secondary|Systolic Blood Pressure in Conjunction With Spirometry at Visit 4|Systolic blood pressure collected in conjunction with spirometry at 12 weeks|After 12 weeks of treatment|Treated set. Some patients discontinued the trial between Visits. Thus these patients are in the efficacy analysis for the respective period (are added in the participant flow) but they have no safety blood pressure/pulse rate measurements, because blood pressure and pulse rate were measured at Visits||mmHg||Standard Deviation|Mean
725015|NCT00350207|Secondary|Systolic Blood Pressure in Conjunction With Spirometry at Visit 3|Systolic blood pressure collected in conjunction with spirometry at 6 weeks|After 6 weeks of treatment|Treated set. Some patients discontinued the trial between Visits. Thus these patients are in the efficacy analysis for the respective period (are added in the participant flow) but they have no safety blood pressure/pulse rate measurements, because blood pressure and pulse rate were measured at Visits||mmHg||Standard Deviation|Mean
725016|NCT00350207|Secondary|Mini-AQLQ Overall Score at Visit 5|Mean of the responses to 15 questions from 4 domains: Symptoms (1), Activity Limitations (2), Emotional Function (3), Environmental Stimuli (4). Unit on a scale 1-7. For domain (2): 1: totally limited, 2: extremely limited, 3: very limited, 4: moderate limitation, 5: some limitation, 6: a little limitation, 7: not at all limited. For other domains: 1: all of the time, 2: most of the time, 3: a good bit of the time, 4: some of the time, 5: a little of the time, 6: hardly any of the time, 7: none of the time. 7 is the best value|After 16 weeks of treatment|FAS||Unit on a scale||Standard Error|Least Squares Mean
725017|NCT00350207|Secondary|Mini-AQLQ Overall Score at Visit 4|Mean of the responses to 15 questions from 4 domains: Symptoms (1), Activity Limitations (2), Emotional Function (3), Environmental Stimuli (4). Unit on a scale 1-7. For domain (2): 1: totally limited, 2: extremely limited, 3: very limited, 4: moderate limitation, 5: some limitation, 6: a little limitation, 7: not at all limited. For other domains: 1: all of the time, 2: most of the time, 3: a good bit of the time, 4: some of the time, 5: a little of the time, 6: hardly any of the time, 7: none of the time. 7 is the best value|After 12 weeks of treatment|FAS||Unit on a scale||Standard Error|Least Squares Mean
725018|NCT00350207|Secondary|Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ) Overall Score at Visit 3|Mean of the responses to 15 questions from 4 domains: Symptoms (1), Activity Limitations (2), Emotional Function (3), Environmental Stimuli (4). Unit on a scale 1-7. For domain (2): 1: totally limited, 2: extremely limited, 3: very limited, 4: moderate limitation, 5: some limitation, 6: a little limitation, 7: not at all limited. For other domains: 1: all of the time, 2: most of the time, 3: a good bit of the time, 4: some of the time, 5: a little of the time, 6: hardly any of the time, 7: none of the time. 7 is the best value|After 6 weeks of treatment|FAS||Unit on a scale||Standard Error|Least Squares Mean
725019|NCT00350207|Secondary|Morning Pre-dose Forced Vital Capacity as Measured by Spirometry at Visit 5|Morning pre-dose forced vital capacity as measured by spirometry after 16 weeks of treatment|After 16 weeks of treatment|FAS||L||Standard Error|Least Squares Mean
725020|NCT00350207|Secondary|Morning Pre-dose Forced Vital Capacity as Measured by Spirometry at Visit 4|Morning pre-dose forced vital capacity as measured by spirometry after 12 weeks of treatment|After 12 weeks of treatment|FAS||L||Standard Error|Least Squares Mean
725021|NCT00350207|Secondary|Morning Pre-dose Forced Vital Capacity as Measured by Spirometry at Visit 3|Morning pre-dose forced vital capacity as measured by spirometry after 6 weeks of treatment|After 6 weeks of treatment|FAS||L||Standard Error|Least Squares Mean
725022|NCT00350207|Secondary|Morning Pre-dose Forced Expiratory Volume in 1 Second as Measured by Spirometry at Visit 5|Morning pre-dose forced expiratory volume in 1 second as measured by spirometry after 16 weeks od treatment|After 16 weeks of treatment|FAS||L||Standard Error|Least Squares Mean
725023|NCT00350207|Secondary|Morning Pre-dose Forced Expiratory Volume in 1 Second as Measured by Spirometry at Visit 4|Morning pre-dose forced expiratory volume in 1 second as measured by spirometry after 12 weeks of treatment|After 12 weeks of treatment|FAS||L||Standard Error|Least Squares Mean
725024|NCT00350207|Secondary|Morning Pre-dose Forced Expiratory Volume in 1 Second as Measured by Spirometry at Visit 3|Morning pre-dose forced expiratory volume in 1 second as measured by spirometry after 6 weeks of treatment|After 6 weeks of treatment|FAS||L||Standard Error|Least Squares Mean
725025|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question Did You Experience Wheeze or Cough During the Day at Week 16"|Unit on a scale 1-5. 1: Not at all, 2: A little of the time, 3: A moderate amount of the time, 4: Most of the time, 5: All the time. 1 is the best value|After 16 weeks of treatment|FAS||Unit on a scale||Standard Error|Least Squares Mean
725026|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question Did You Experience Wheeze or Cough During the Day at Week 12"|Unit on a scale 1-5. 1: Not at all, 2: A little of the time, 3: A moderate amount of the time, 4: Most of the time, 5: All the time. 1 is the best value|After 12 weeks of treatment|FAS||Unit on a scale||Standard Error|Least Squares Mean
725027|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question Did You Experience Wheeze or Cough During the Day at Week 8"|Unit on a scale 1-5. 1: Not at all, 2: A little of the time, 3: A moderate amount of the time, 4: Most of the time, 5: All the time. 1 is the best value|After 8 weeks of treatment|FAS||Unit on a scale||Standard Error|Least Squares Mean
725028|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question Did You Experience Wheeze or Cough During the Day at Week 4"|Unit on a scale 1-5. 1: Not at all, 2: A little of the time, 3: A moderate amount of the time, 4: Most of the time, 5: All the time. 1 is the best value|After 4 weeks of treatment|FAS||Unit on a scale||Standard Error|Least Squares Mean
725029|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question How Much Shortness of Breath Did You Experience During the Day at Week 16"|Unit on a scale 1-5. 1: None, 2: A very little, 3: A moderate amount, 4: Quite a lot, 5: A very great deal. 1 is the best value|After 16 weeks of treatment|FAS||Unit on a scale||Standard Error|Least Squares Mean
725030|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question How Much Shortness of Breath Did You Experience During the Day at Week 12"|Unit on a scale 1-5. 1: None, 2: A very little, 3: A moderate amount, 4: Quite a lot, 5: A very great deal. 1 is the best value|After 12 weeks of treatment|FAS||Unit on a scale||Standard Error|Least Squares Mean
725031|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question How Much Shortness of Breath Did You Experience During the Day at Week 8"|Unit on a scale 1-5. 1: None, 2: A very little, 3: A moderate amount, 4: Quite a lot, 5: A very great deal. 1 is the best value|After 8 weeks of treatment|FAS||Unit on a scale||Standard Error|Least Squares Mean
725032|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question How Much Shortness of Breath Did You Experience During the Day at Week 4"|Unit on a scale 1-5. 1: None, 2: A very little, 3: A moderate amount, 4: Quite a lot, 5: A very great deal. 1 is the best value|After 4 weeks of treatment|FAS||Unit on a scale||Standard Error|Least Squares Mean
725033|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question How Limited Were You in Your Activities Today Because of Your Asthma at Week 16"|Unit on a scale 1-5. 1: Not limited at all, 2: A little limited, 3: Moderately limited, 4: Severely limited, 5: Totally limited. 1 is the best value|After 16 weeks of treatment|FAS||Unit on a scale||Standard Error|Least Squares Mean
725034|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question How Limited Were You in Your Activities Today Because of Your Asthma at Week 12"|Unit on a scale 1-5. 1: Not limited at all, 2: A little limited, 3: Moderately limited, 4: Severely limited, 5: Totally limited. 1 is the best value|After 12 weeks of treatment|FAS||Unit on a scale||Standard Error|Least Squares Mean
725035|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question How Limited Were You in Your Activities Today Because of Your Asthma at Week 8"|Unit on a scale 1-5. 1: Not limited at all, 2: A little limited, 3: Moderately limited, 4: Severely limited, 5: Totally limited. 1 is the best value|After 8 weeks of treatment|FAS||Unit on a scale||Standard Error|Least Squares Mean
725036|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question How Limited Were You in Your Activities Today Because of Your Asthma at Week 4"|Unit on a scale 1-5. 1: Not limited at all, 2: A little limited, 3: Moderately limited, 4: Severely limited, 5: Totally limited. 1 is the best value|After 4 weeks of treatment|FAS||Unit on a scale||Standard Error|Least Squares Mean
725037|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms During the Day at Week 16"|Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value|After 16 weeks of treatment|FAS||Unit on a scale||Standard Error|Least Squares Mean
725038|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms During the Day at Week 12"|Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value|After 12 weeks of treatment|FAS||Unit on a scale||Standard Error|Least Squares Mean
725039|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms During the Day at Week 8"|Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value|After 8 weeks of treatment|FAS||Unit on a scale||Standard Error|Least Squares Mean
725040|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms During the Day at Week 4"|Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value|After 4 weeks of treatment|FAS||Unit on a scale||Standard Error|Least Squares Mean
725041|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms This Morning at Week 16"|Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value|After 16 weeks of treatment|FAS||Unit on a scale||Standard Error|Least Squares Mean
725042|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms This Morning at Week 12"|Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value|After 12 weeks of treatment|FAS||Unit on a scale||Standard Error|Least Squares Mean
725043|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms This Morning at Week 8"|Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value|After 8 weeks of treatment|FAS||Unit on a scale||Standard Error|Least Squares Mean
725044|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms in the Morning at Week 4"|Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value|After 4 weeks of treatment|FAS||Unit on a scale||Standard Error|Least Squares Mean
725045|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question Did You Wake up During the Night Due to Asthma at Week 16"|Unit on a scale 1-5. 1: Did not wake up, 2: Woke up once, 3: Woke up 2-5 times, 4: Woke up more than 5 times, 5: Was awake all night. 1 is the best value|After 16 weeks of treatment|FAS||Unit on a scale||Standard Error|Least Squares Mean
725046|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question Did You Wake up During the Night Due to Asthma at Week 12"|Unit on a scale 1-5. 1: Did not wake up, 2: Woke up once, 3: Woke up 2-5 times, 4: Woke up more than 5 times, 5: Was awake all night. 1 is the best value|After 12 weeks of treatment|FAS||Unit on a scale||Standard Error|Least Squares Mean
725047|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question Did You Wake up During the Night Due to Asthma at Week 8"|Unit on a scale 1-5. 1: Did not wake up, 2: Woke up once, 3: Woke up 2-5 times, 4: Woke up more than 5 times, 5: Was awake all night. 1 is the best value|After 8 weeks of treatment|FAS||Unit on a scale||Standard Error|Least Squares Mean
725048|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question Did You Wake up During the Night Due to Asthma at Week 4"|Unit on a scale 1-5. 1: Did not wake up, 2: Woke up once, 3: Woke up 2-5 times, 4: Woke up more than 5 times, 5: Was awake all night. 1 is the best value|After 4 weeks of treatment|FAS||Unit on a scale||Standard Error|Least Squares Mean
725049|NCT00350207|Secondary|Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 16|Mean weekly evening forced expiratory volume in 1 second at week 16, pre-dose|After 16 weeks of treatment|FAS||L||Standard Error|Least Squares Mean
725050|NCT00350207|Secondary|Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 12|Mean weekly evening forced expiratory volume in 1 second at week 12, pre-dose|After 12 weeks of treatment|FAS||L||Standard Error|Least Squares Mean
725051|NCT00350207|Secondary|Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 8|Mean weekly evening forced expiratory volume in 1 second at week 8, pre-dose|After 8 weeks of treatment|FAS||L||Standard Error|Least Squares Mean
725052|NCT00350207|Secondary|Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 4|Mean weekly evening forced expiratory volume in 1 second at week 4, pre-dose|After 4 weeks of treatment|FAS||L||Standard Error|Least Squares Mean
725053|NCT00350207|Secondary|Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 16|Mean weekly morning forced expiratory volume in 1 second at week 16, pre-dose|After 16 weeks of treatment|FAS||L||Standard Error|Least Squares Mean
725054|NCT00350207|Secondary|Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 12|Mean weekly morning forced expiratory volume in 1 second at week 12, pre-dose|After 12 weeks of treatment|FAS||L||Standard Error|Least Squares Mean
725055|NCT00350207|Secondary|Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 8|Mean weekly morning forced expiratory volume in 1 second at week 8, pre-dose|After 8 weeks of treatment|FAS||L||Standard Error|Least Squares Mean
725056|NCT00350207|Secondary|Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 4|Mean weekly morning forced expiratory volume in 1 second at week 4, pre-dose|After 4 weeks of treatment|FAS||L||Standard Error|Least Squares Mean
725057|NCT00350207|Secondary|Mean Weekly Evening Peak Expiratory Flow at Week 16|Mean weekly evening peak expiratory flow at week 16, pre-dose|After 16 weeks of treatment|FAS||L/min||Standard Error|Least Squares Mean
725058|NCT00350207|Secondary|Mean Weekly Evening Peak Expiratory Flow at Week 12|Mean weekly evening peak expiratory flow at week 12, pre-dose|After 12 weeks of treatment|FAS||L/min||Standard Error|Least Squares Mean
725059|NCT00350207|Secondary|Mean Weekly Evening Peak Expiratory Flow at Week 8|Mean weekly evening peak expiratory flow at week 8, pre-dose|After 8 weeks of treatment|FAS||L/min||Standard Error|Least Squares Mean
725060|NCT00350207|Secondary|Mean Weekly Evening Peak Expiratory Flow at Week 4|Mean weekly evening peak expiratory flow at week 4, pre-dose|After 4 weeks of treatment|FAS||L/min||Standard Error|Least Squares Mean
725061|NCT00350207|Secondary|Mean Weekly Morning Peak Expiratory Flow at Week 16|Mean weekly morning peak expiratory flow at week 16, pre-dose|After 16 weeks of treatment|FAS||L/min||Standard Error|Least Squares Mean
725062|NCT00350207|Secondary|Mean Weekly Morning Peak Expiratory Flow at Week 12|Mean weekly morning peak expiratory flow at week 12, pre-dose|After 12 weeks of treatment|FAS||L/min||Standard Error|Least Squares Mean
725063|NCT00350207|Secondary|Mean Weekly Morning Peak Expiratory Flow at Week 8|Mean weekly morning peak expiratory flow at week 8, pre-dose|After 8 weeks of treatment|FAS||L/min||Standard Error|Least Squares Mean
725064|NCT00350207|Secondary|Mean Weekly Morning Peak Expiratory Flow at Week 4|Mean weekly morning peak expiratory flow at week 4, pre-dose|After 4 weeks of treatment|FAS||L/min||Standard Error|Least Squares Mean
725065|NCT00350207|Primary|Change in Mean Weekly Morning Peak Expiratory Flow From Baseline to the End of the Trial|Change from baseline in mean weekly morning peak expiratory flow at 16 weeks. Baseline is defined as the last week prior to the randomisation visit|baseline and after 16 weeks of treatment|The Full analysis set (FAS) included patients who received at least one dose of randomised study medication and who had at least four patient diary records for at least one efficacy endpoint in any week after the first administration of the randomised treatment and baseline data for the corresponding efficacy endpoint.||L/min||Standard Error|Least Squares Mean
725066|NCT00350220|Primary|Peak Arterial Lactate Level|Peak arterial lactate level for the 48 hour post-op study period.|48 hours|||mmol/l||Standard Deviation|Mean
725067|NCT00350220|Secondary|Mortality Before Hospital Discharge||30 days||||||
725068|NCT00350220|Secondary|Volume of Blood Transfused||3 days||||||
725069|NCT00350220|Secondary|Length of Vasoactive Agent Administration||3 days||||||
725070|NCT00350220|Secondary|Length of Oxygen Use||3 days||||||
725071|NCT00350220|Secondary|Length of Mechanical Ventilation||3 days||||||
725072|NCT00350220|Secondary|Oxygen Utilization During the 8 Hour to 72 Hours Post-operative Period.||3 days||||||
725073|NCT00350220|Primary|Mean Arterial Lactate Level|Mean arterial lactate for the first 48 hours post-op.|48 hours|||mmol/L||Standard Deviation|Mean
725074|NCT00350272|Primary|The Safety Profile of Elvucitabine.|Determination of the safety profile of elvucitabine as defined by the frequency, type and severity of treatment-emergent adverse events and the frequency of Grade 3 and Grade 4 laboratory abnormalities.|12 Weeks|The analysis population for safety and tolerability was the safety population, defined as all randomized subjects who received at least one dose of study drug.||participants|||Number
725075|NCT00350272|Primary|The Proportion of Subjects With Virologic Response for 10 mg/Day Elvucitabine in HIV-1-infected Subjects by 12 Weeks Compared With the Proportion of Subjects With Lamivudine 300 mg/Day.|Proportion of subjects having achieved a virologic response for elvucitabine 10 mg/day in combination with efavirenz and tenofovir in HIV-1-infected subjects over 12 weeks compared with the proportion of subjects having achieved a virologic response for lamivudine 300 mg/day in combination with efavirenz and tenofovir. Virologic response was defined as having achieved undetectable (<50 copies/mL) HIV-1 RNA levels from baseline assessment.|12 Weeks|This primary outcome measure used the intent-to-treat population, defined as all randomized subjects who took at least 1 dose of study drug and had both a baseline HIV-1 RNA result and at least 1 HIV-1 RNA result after baseline assessment. For this analysis, all subjects who discontinued from the study before Week 12 were considered as NC=F.||percentage of participants|||Number
725076|NCT00350363|Primary|Number of Participant With Positive Culture||2 weeks|||participants|||Number
725077|NCT00350402|Primary|Change in Facial Entropy Score From Baseline [On Dopamine Medication]|Outcome is entropy change from baseline to immediate completion of 4 week intervention when participants remained on their normal dosage of dopamine medication. Entropy is quantitative index of facial movement that is computed from changes in pixel intensity as the face moves. Entropy values range from 0 up to 100. Higher scores reflect greater movement and expressivity. Greater expressivity is desired outcome.|Baseline and 4 weeks (i.e., immediate after 4-week intervention)|Based on individuals who completed baseline and post-treatment assessment following 4 weeks of intervention. One individual from each treatment group dropped out during the first week of intervention and were not included in analyses.||Units on a scale||Standard Deviation|Mean
725078|NCT00350402|Other Pre-specified|Change From Baseline in Maximal Inspiratory Pressure (MIP)|The dependent variable is the change in maximal inspiratory pressure (MIP) from baseline to immediate completion of 4-week intervention. MIP refers to how much air pressure force an individual creates by inhaling through the mouth as hard as possible. This was measured over 5-7 trials by placement of lips around a mouthpiece attached to a calibrated fluke digital pressure gauge. From these trials, an average maximum inspiratory pressure (MIP) was computed. This was done at baseline and post-treatment. Greater MIP changes correspond to greater treatment-related effects of exercise.|Baseline and 4 weeks (i.e., immediate after 4-week intervention)|Included participants who underwent baseline, intervention, and post-treatment assessment. Two individuals dropped out during the first week of intervention, one from each intervention group. Additionally, there was faulty data, due to equipment failure for one individual in the sham group, thereby reducing N in this group to 19.||units of pressure (cmH20)||Standard Deviation|Mean
725079|NCT00350402|Secondary|Change in Parkinson Disease Quality of Life-39 Scale (PDQ-39)|The PDQ-39 is a widely used quality of life measure that is specific to Parkinson disease. Total raw score on the PDQ-39 ranges from 0 to 156. Higher scores reflect worse quality of life rating. Total score on PDQ-39 was used to compute pre-post treatment changes.|Baseline and 4 weeks (i.e., immediate post-intervention)|Participants who completed baseline,intervention, and post-intervention testing. Two individuals, one from each group, dropped out of the study during the first week of intervention.||units on a scale||Standard Deviation|Mean
725080|NCT00350402|Primary|Change in Facial Entropy Score From Baseline [Off Dopamine Medication]|"Primary outcome is change in entropy score from baseline to immediate completion of 4 week intervention. Entropy is a computer derived index of facial movement that is computed by quantifying changes in pixel intensity as the face moves over a series of video frames. Entropy values range from 0 up to 100. Higher scores reflect greater movement and expressivity (desired). In this condition (off dopamine), entropy scores were obtained when participants were tested off their normal dopamine medications. Off-dopamine testing occurred after a 12-hour overnight washout period."|Baseline and 4 weeks (i.e., immediate after 4-week treatment)|All participants who completed baseline, intervention, and post-testing. Two participants, one from each group, dropped out during first week of intervention.||units on a scale||Standard Deviation|Mean
725081|NCT00350519|Secondary|Hospital Length of Stay||Surgery to hospital discharge|ITT, No formal analysis was conducted due to early termination and small sample size||days||Standard Deviation|Mean
725082|NCT00350519|Secondary|Number of pRBC Units Transfused During Study||Baseline (Day -10) to end of study (Day 32)|ITT, No formal analysis was conducted due to early termination and small sample size||units||Standard Deviation|Mean
725083|NCT00350519|Secondary|Hemoglobin Change From Baseline to End of Study|End of Study Hemoglobin minus baseline Hemoglobin|Baseline (Day-10) to end of study (Day 32)|All Subjects, No formal analysis was conducted due to early termination and small sample size||g/dL||Standard Deviation|Mean
725084|NCT00350519|Primary|Number of Participants Receiving pRBC (Packed Red Blood Cell) Transfusions||Day of surgery until hospital discharge|ITT(intention to treat), No formal analysis was conducted due to early termination and small sample size||participants|||Number
725085|NCT00350532|Primary|Acetylcholine Concentration in Cerebrospinal Fluid|Acetylcholine levels in CSF after administration of intrathecal clonidine measured by High-performance liquid chromatography (HPLC).|60 minutes|There was no difference noted in acetylcholine levels in healthy subjects compared to subjects with chronic pain||picograms per milliliter (pg/ml)||Full Range|Mean
725086|NCT00350623|Primary|Number of Enzyme-linked Immunosorbent Spot (ELISPOT) Responders at 30 Weeks||30 weeks|No data analysis was performed.|||||
725087|NCT00350636|Secondary|Change From Baseline in Average Urine Void Volume|Change from baseline to Week 12 in average urine void volume|Change from Baseline to Week 12|||mL||Standard Deviation|Mean
725088|NCT00350636|Secondary|Baseline Average Urine Void Volume|Baseline average urine void volume|Baseline|||mL||Standard Deviation|Mean
725089|NCT00350636|Primary|Change From Baseline in Average Daily Number of Incontinence Episodes|Change from Baseline to Week 12 in average daily number of incontinence episodes|Baseline to Week 12|||Number of episodes||Standard Deviation|Mean
725090|NCT00350636|Secondary|Change From Baseline in Average Daily Urinary Frequency|Change from baseline in average daily urinary frequency|Baseline to 12 weeks|||Number of urinary episodes||Standard Deviation|Mean
725093|NCT00350727|Primary|Progression-free Survival at 6 Months|Progression-free survival (PFS) analysis was performed on all participants. PFS is presented as the number of participants experiencing disease progression or death due to any cause. Participants who are alive and have not progressed at the time of analysis are considered censored, and the date associated with the last visit with disease assessment will be used. The participants who are still alive and whose follow-up extends to at least 6 months are considered At Risk.|Date of the first dose of study drug to 6 months|All-treated Population for Phase II||participants|||Number
725094|NCT00350727|Primary|Overall Response (OR) in Phase II Based on an Independent Radiologist's Review|OR is the number of participants whose response was classified as a complete response or partial response (disappearance of enhancing tumor (ET) or reduction of ET by >=50%, respectively, on consecutive scans [CS] >=1 month (m) apart, off steroids, and neurologically stable/improved), progressive disease (increase of ET of >=25% on CS >=1 m apart or neurologically worse, and steroids stable/increased), or stable disease (all other situations) per MacDonald criteria. Participants were evaluated with magnetic resonance imaging. Baseline and the 4- and 8-w assessments are categorized as <8 w.|Date of first dose of study drug to date of documented and confirmed progression, or to date of death due to any cause (assessed at baseline, 4 and 8 weeks, and every 8 weeks thereafter until study withdrawal; up to Day 878)|All-treated Population for Phase II who also had a response assessment||participants|||Number
725095|NCT00350727|Secondary|Time to Disease Progression or Death Due to Any Cause||Date of the first dose of study drug to the date of documented and confirmed progression by Mac Donald criteria, or to date of death due to any cause (up to Day 878)|All-treated Population for Phase II||days||95% Confidence Interval|Median
725096|NCT00350727|Secondary|Progression-free Survival|Progression-free survival (PFS) analysis was performed on all participants. PFS is presented as the number of participants experiencing disease progression or death due to any cause. Participants who are alive and have not progressed at the time of analysis are considered censored, and the date associated with the last visit with disease assessment will be used.|Date of the first dose of study drug to the date of documented and confirmed progression by Mac Donald criteria, or to date of death due to any cause (up to Day 878)|All-treated Population for Phase II||participants|||Number
725097|NCT00350727|Primary|Overall Response (OR) in Phase II Based on the Investigator-assigned Response|OR is the number of participants whose response was classified as a complete response or partial response (disappearance of enhancing tumor (ET) or reduction of ET by >=50%, respectively, on consecutive scans [CS] >=1 month (m) apart, off steroids, and neurologically stable/improved), progressive disease (increase of ET of >=25% on CS >=1 m apart or neurologically worse, and steroids stable/increased), or stable disease (all other situations) per MacDonald criteria. Participants were evaluated with magnetic resonance imaging. Baseline and the 4- and 8-w assessments are categorized as <8 w.|Date of first dose of study drug to date of documented and confirmed progression, or to date of death due to any cause (assessed at baseline, 4 and 8 weeks, and every 8 weeks thereafter until study withdrawal; up to Day 878)|All-treated Population for Phase II who also had a response assessment.||participants|||Number
725098|NCT00350727|Primary|Overall Response (OR) in Phase II Based GlaxoSmithKline's Evaluation|OR is the number of participants whose response was classified as a complete response or partial response (disappearance of enhancing tumor (ET) or reduction of ET by >=50%, respectively, on consecutive scans [CS] >=1 month (m) apart, off steroids, and neurologically stable/improved), progressive disease (increase of ET of >=25% on CS >=1 m apart or neurologically worse, and steroids stable/increased), or stable disease (all other situations) per MacDonald criteria. Participants were evaluated with magnetic resonance imaging. Baseline and the 4- and 8-w assessments are categorized as <8 w.|Date of first dose of study drug to date of documented and confirmed progression, or to date of death due to any cause (assessed at baseline, 4 and 8 weeks, and every 8 weeks thereafter until study withdrawal; up to Day 878)|All-treated Population in Phase II who also had a response assessment||participants|||Number
725099|NCT00350727|Primary|Number of Participants Experiencing a Dose-limiting Toxicity at the Indicated Dose|A dose-limiting toxicity (DLT) is defined as predefined adverse events or events that prevented participants from receiving 75% of their scheduled doses or from starting their next treatment period. The dose at which no more than 1 out of 6 participants experiences a DLT is defined as the optimally tolerated regimen. The OTR is important because it determines the highest dose combination that can be given without significant toxicity.|Cycle 1 in Phase I (up to Day 28)|All-treated Population for Phase I||participants|||Number
725100|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase I of the Study for Partial Thromboplastin Time and Prothrombin Time|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. Partial thromboplastin time is a performance indicator detecting abnormalities in blood clotting.|Baseline to study completion (up to 844 days for Phase I)|All-treated Population for Phase I. Data are presented for only those participants who provided hematology measurements at both baseline and post-baseline.||seconds (sec)||Standard Deviation|Mean
725101|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase I of the Study for International Normalized Ratio (Prothrombin Time)|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. Prothrombin time is a measure of the extrinsic pathway of coagulation that is used to determine the clotting tendency of blood. The International Normalized Ratio is the ratio of a patient's prothrombin time to a normal (control) sample.|Baseline to study completion (up to 844 days for Phase I)|All-treated Population for Phases I and II. Data are presented for only those participants who provided hematology measurements at both baseline and post-baseline.||ratio||Standard Deviation|Mean
725102|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in the Study for Lymphocytes, Neutrophils, Platelet Count, and White Blood Count|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 844 days for Phase I)|All-treated Population for Phase I. Data are presented for only those participants who provided hematology measurements at both baseline and post-baseline.||giga (10^9) per liter (GI/L)||Standard Deviation|Mean
725103|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase I of the Study for Hematocrit|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. The hematocrit is the proportion of blood volume that is occupied by red blood cells.|Baseline to study completion (up to 844 days for Phase I)|All-treated Population for Phase I. Data are presented for only those participants who provided hematology measurements at both baseline and post-baseline.||percent||Standard Deviation|Mean
725104|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase I of the Study for Hemoglobin|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 844 days for Phase I)|All-treated Population for Phase I. Data are presented for only those participants who provided hematology measurements at both baseline and post-baseline.||grams per Liter (g/L)||Standard Deviation|Mean
725105|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase I of the Study for Total T3|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 844 days for Phase I)|All-treated Population for Phase I. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline. For some arms, data were not collected for either baseline or post-baseline assessments.||nanomoles per liter (nmol/l)||Standard Deviation|Mean
725106|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase I of the Study for Thyroid Stimulating Hormone|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 844 days for Phase I)|All-treated Population for Phase I. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline.||milliunits per liter (mU/L)||Standard Deviation|Mean
725107|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase I of the Study for Free T3 (Triiodothyronine)|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 844 days for Phase I)|All-treated Population for Phase I. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline. For some arms, data were not collected for either baseline or post-baseline assessments.||picomoles per liter (pmol/l)||Standard Deviation|Mean
725108|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase I of the Study for Thyroxine|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 844 days for Phase I)|All-treated Population for Phase I. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline.||picomoles per liter (pmol/l)||Standard Deviation|Mean
725109|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase I of the Study for Calcium, Glucose, Potassium, Magnesium, Inorganic Phosphorus, Sodium, and Urea|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 844 days for Phase I)|All-treated Population for Phase I. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline.||millimoles per liter (mmol/l)||Standard Deviation|Mean
725110|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase I of the Study for Total Bilirubin and Creatinine|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 844 days for Phase I)|All-treated Population for Phase I. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline.||micromoles per liter (µmol/l)||Standard Deviation|Mean
725111|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase I of the Study for Amylase and Lipase|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 844 days for Phase I)|All-treated Population for Phase I. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline.||Units per liter (U/L)||Standard Deviation|Mean
725112|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase I of the Study for Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, and Lactate Dehydrogenase|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 844 days for Phase I)|All-treated Population for Phase I. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline.||International Units per Liter (IU/L)||Standard Deviation|Mean
725113|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase I of the Study for Albumin|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 844 days for Phase I)|All-treated Population for Phase I. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline.||grams per liter (g/L)||Standard Deviation|Mean
725114|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase II of the Study for Partial Thromboplastin Time and Prothrombin Time|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. Partial thromboplastin time is a performance indicator detecting abnormalities in blood clotting.|Baseline to study completion (up to 878 days for Phase II)|All-treated Population for Phase II. Data are presented for only those participants who provided hematology measurements at both baseline and post-baseline.||seconds (sec)||Standard Deviation|Mean
725115|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase II of the Study for International Normalized Ratio (Prothrombin Time)|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. Prothrombin time is a measure of the extrinsic pathway of coagulation that is used to determine the clotting tendency of blood. The International Normalized Ratio is the ratio of a patient's prothrombin time to a normal (control) sample.|Baseline to study completion (up to 878 days for Phase II)|All-treated Population for Phase. Data are presented for only those participants who provided hematology measurements at both baseline and post-baseline.||ratio||Standard Deviation|Mean
725116|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase II of the Study for Lymphocytes, Neutrophils, Platelet Count, and White Blood Count|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 878 days for Phase II)|All-treated Population for Phase II. Data are presented for only those participants who provided hematology measurements at both baseline and post-baseline.||giga (10^9) per liter (GI/L)||Standard Deviation|Mean
725117|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase II of the Study for Hematocrit|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. The hematocrit is the proportion of blood volume that is occupied by red blood cells.|Baseline to study completion (up to 878 days for Phase II)|All-treated Population for Phase II. Data are presented for only those participants who provided hematology measurements at both baseline and post-baseline.||percent||Standard Deviation|Mean
725118|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase II of the Study for Hemoglobin|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 878 days for Phase II)|All-treated Population for Phase II. Data are presented for only those participants who provided hematology measurements at both baseline and post-baseline.||grams per liter (g/L)||Standard Deviation|Mean
725119|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase II of the Study for Total T3|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 878 days for Phase II)|All-treated Population for Phase II. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline.||nanomoles per liter (nmol/l)||Standard Deviation|Mean
725120|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase II of the Study for Thyroid Stimulating Hormone|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 878 days for Phase II)|All-treated Population for Phase II. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline.||milliunits per liter (mU/L)||Standard Deviation|Mean
725121|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase II of the Study for Thyroxine and Free T3 (Triiodothyronine)|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 878 days for Phase II)|All-treated Population for Phase II. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline.||picomoles per liter (pmol/l)||Standard Deviation|Mean
725122|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase II of the Study for Calcium, Glucose, Potassium, Magnesium, Inorganic Phosphorus, Sodium, and Urea|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 878 days for Phase II)|All-treated Population for Phase II. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline.||millimoles per liter (mmol/l)||Standard Deviation|Mean
725123|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase II of the Study for Total Bilirubin and Creatinine|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 878 days for Phase II)|All-treated Population for Phase II. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline.||micromoles per liter (µmol/l)||Standard Deviation|Mean
725124|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase II of the Study for Amylase and Lipase|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 878 days for Phase II)|All-treated Population for Phase II. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline.||Units per liter (U/L)||Standard Deviation|Mean
725125|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase II of the Study for Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, and Lactate Dehydrogenase|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 878 days for Phase II)|All-treated Population for Phase II. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline.||International Units per Liter (IU/L)||Standard Deviation|Mean
725126|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase II of the Study for Albumin|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 878 days for Phase II)|All-treated Population for Phase II. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline.||grams per liter (g/L)||Standard Deviation|Mean
725127|NCT00350727|Primary|Number of Participants With the Indicated Change From Baseline to Study Completion in Heart Rate|Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline (BL) values to investigate what changes occurred. bpm, beats per minute.|Baseline to study completion (up to 844 days for Phase I, up to 878 days for Phase II)|All-treated Population for Phases I and II. One participant withdrew in Phase I due to death; change from baseline was not calculated for this participant.||participants|||Number
725128|NCT00350727|Primary|Number of Participants With the Indicated Change From Baseline to Study Completion in Diastolic Blood Pressure|Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline (BL) values to investigate what changes occurred. mmHg, millimeters of mercury.|Baseline to study completion (up to 844 days for Phase I, up to 878 days for Phase II)|All-treated Population for Phases I and II. One participant withdrew in Phase I due to death; change from baseline was not calculated for this participant.||participants|||Number
725129|NCT00350727|Primary|Number of Participants With the Indicated Change From Baseline to Study Completion in Systolic Blood Pressure|Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline (BL) values to investigate what changes occurred. mmHg, millimeters of mercury.|Baseline to study completion (up to 844 days for Phase I, up to 878 days for Phase II)|All-treated Population (all participants who were given any dose of study medication) for Phases I and II. One participant withdrew in Phase I due to death; change from baseline was not calculated for this participant.||participants|||Number
725130|NCT00350727|Secondary|Phase II: Plasma Concentrations of the Circulating Biomarkers VEGF, sVEGFR-1, and sVEGFR-2.||Completed during first cycle of treatment.||||||
725131|NCT00350727|Secondary|Phase II: Pharmacokinetic Parameters Including AUC(0-24), [AUC(0-12) for Patients on Twice Daily Administration], Cmax, Tmax, and C24 of Pazopanib and Lapatinib, as Appropriate, When Administered Together in Combination With Non-EIAC.||Completed during first cycle of treatment.||||||
725132|NCT00350727|Secondary|Phase I: Pharmacokinetic Parameters Including AUC(0-24), [AUC(0-12) for Patients on Twice Daily Administration], Cmax, the Time to Maximum Observed Concentration (Tmax) and C24 of Pazopanib and Lapatinib When Administered in Combination With EIAC.||Completed during first cycle of treatment.||||||
725149|NCT00351000|Primary|Change From Baseline in Fasting Glucose|Subjects on clozapine with adjunctive ziprasidone were compared to subjects on olanzapine with adjunctive ziprasidone on change in fasting glucose levels from baseline to study endpoint (week 6 - baseline)|baseline, week 6|||mg/dL||Standard Deviation|Mean
725133|NCT00350779|Secondary|Change From Baseline in 2-hour PMG (Post-meal Glucose) at Week 54|Change from baseline at Week 54 is defined as Week 54 minus Week 0.|Baseline and Week 54|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 54, the last non-baseline observed measurement was carried forward to Week 54.||mg/dL||95% Confidence Interval|Least Squares Mean
725134|NCT00350779|Secondary|Change From Baseline in FPG (Fasting Plasma Glucose) at Week 54|Change from baseline at Week 54 is defined as Week 54 minus Week 0|Baseline and Week 54|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 54, the last non-baseline observed measurement was carried forward to Week 54.||mg/dL||95% Confidence Interval|Least Squares Mean
725135|NCT00350779|Secondary|Change From Baseline in HbA1c (Hemoglobin A1C) at Week 54|HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 54 HbA1c percent minus the Week 0 HbA1c percent.|Baseline and Week 54|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 54, the last non-baseline observed measurement was carried forward to Week 54.||Percent||95% Confidence Interval|Least Squares Mean
725136|NCT00350779|Secondary|Change From Baseline in 2-hour PMG (Post-meal Glucose) at Week 18|Change from baseline at Week 18 is defined as Week 18 minus Week 0|Baseline and Week 18|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 18, the last non-baseline observed measurement was carried forward to Week 18.||mg/dL||95% Confidence Interval|Least Squares Mean
725137|NCT00350779|Secondary|Change From Baseline in FPG (Fasting Plasma Glucose) at Week 18|Change from baseline at Week 18 is defined as Week 18 minus Week 0|Baseline and 18 Weeks|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 18, the last non-baseline observed measurement was carried forward to Week 18.||mg/dL||95% Confidence Interval|Least Squares Mean
725138|NCT00350779|Primary|Change From Baseline in HbA1c (Hemoglobin A1C) at Week 18|HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent.|Baseline and 18 Weeks|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 18, the last non-baseline observed measurement was carried forward to Week 18.||Percent||95% Confidence Interval|Least Squares Mean
725139|NCT00350792|Secondary|Estimated Probability of One Year Progression-free Survival|Progression free survival (PFS) is the duration from enrollment until first disease progression or death. For patients not known to have died as of the data cut-off date and who do not have progressive disease, PFS is censored at the last radiological assessment date.|baseline to measured progressive disease or death, 1 year|Six patients were censored as they had not experienced a qualifying event (death or first disease progression) at the time of data cut-off.||percentage of patients||95% Confidence Interval|Median
725140|NCT00350792|Secondary|Overall Survival|Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.|baseline to date of death from any cause (up to 14.5 months)|Twenty patients were censored as they were still alive at the time of the data cut-off.||months||95% Confidence Interval|Median
725141|NCT00350792|Secondary|Time to Treatment Failure|Defined as the time from study enrollment to the first observation of disease progression, death as a result of any cause, or early discontinuation of treatment. Time to treatment failure was censored at the date of the last follow-up visit for patients who did not discontinue early, who were still alive, and who have not progressed.|baseline to stopping treatment (up to six 21-day cycles)|All treated patients. 29 patients were censored.||weeks||95% Confidence Interval|Median
725142|NCT00350792|Other Pre-specified|Time to Treatment Failure|Defined as the time from study enrollment to the first observation of disease progression, death as a result of any cause, or early discontinuation of treatment. Time to treatment failure was censored at the date of the last follow-up visit for patients who did not discontinue early, who were still alive, and who have not progressed.|baseline to stopping treatment (up to six 21-day cycles)|All treated patients. 29 patients were censored.||weeks||Standard Error|Mean
725143|NCT00350792|Primary|Percentage of Participants With a Complete or Partial Tumor Response (Overall Tumor Response)|Tumor response is defined as the percentage of patients with either a complete response or a partial response. Response was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions and Partial Response=30% decrease in sum of longest diameter of target lesions.|baseline to measured objective tumor response (up to six 21-day cycles)|Patients qualified for tumor response analysis: treated patients, with measurable advanced non-small cell lung cancer (NSCLC) disease and at least one tumor assessment after the patient received at least a first cycle of chemotherapy (unless early progression occurs, including early clinical progressions confirmed by the assessment committee).||percentage of participants|||Number
725144|NCT00350844|Secondary|Compliance|Secondary outcome measures included compliance; laboratory measures of therapy-related toxicity; laboratory biomarkers for hemolysis, oxidative stress and endothelial injury; and quality of life measures by Child Health Questionnaire (CHQ).|Throughout study||||||
725145|NCT00350844|Primary|Tricuspid Regurgitant Jet Velocity|Primary outcome measure was tricuspid regurgitant jet velocity (TRJV) by echocardiogram after 6 and 12 months of hydroxyurea therapy.|6 and 12 months after HU therapy begins|Study was terminated and 0 participants were analyzed.|||||
725146|NCT00350870|Primary|Change in Cocaine Use by Urine Toxicology Results|We will use the Roche onsite TESTCUP system for detection of cocaine, methamphetamine, THC, benzodiazepenes, and opioids.|12 weeks|||percentage of negative urines||Standard Deviation|Mean
725147|NCT00350870|Primary|Change in Cocaine Use by Self Report|Self-reports of substance use will be documented at each contact via the Substance Use Calendar. Similar to the Form-90 and the Time Line Follow-Back, which have been shown to be reliable and valid instruments for monitoring substance use and other outcomes in longitudinal studies202-204, the Substance Use Calendar allows a flexible, continuous evaluation of substance use on a daily basis.|12 weeks|||percentage of days abstinent||Standard Deviation|Mean
725153|NCT00344019|Primary|Peri-procedural Myonecrosis|As measured by troponin T (TnT), during percutaneous coronary intervention (PCI). TnT will be measured at 18-24 hours. Assuming a 40% event rate (elevation in TnT), this study powered to predict 30% relative reduction in TnT|24 hours|Study closed due to slow recruitment and data was not analyzed. Collected data is no longer available as retention period has passed and investigator has left the institution.|||||
725154|NCT00344032|Secondary|Number of Subjects Reporting Serious Adverse Events|Serious adverse events assessed include medical occurrences that results in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Throughout the study period (up to Month 7)|||Subjects|||Number
725155|NCT00344032|Secondary|Number of Subjects Reporting Unsolicited Adverse Events as New Onset Chronic Diseases (NOCDs) and Other Medically Significant Adverse Events (AEs)|NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes. Medically significant AEs assessed include AEs prompting emergency room or physician visits that are not related to common diseases or SAEs that are not related to common diseases.|Throughout the study period (up to Month 7)|||Subjects|||Number
725156|NCT00344032|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|"Unsolicited adverse event = Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event."|Within 30 days (Days 0 - 29) after each vaccination|||Subjects|||Number
725157|NCT00344032|Secondary|Number of Subjects Reporting Solicited Symptoms|Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include arthralgia, fatigue, fever, gastro-intestinal symptoms, headache, myalgia, rash and urticaria.|During the 7 days (Days 0 - 6) after each vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.||Subjects|||Number
725158|NCT00344032|Secondary|Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies|Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).|At Months 0 and 7|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.||EL.U/mL||95% Confidence Interval|Geometric Mean
725159|NCT00344032|Primary|Number of Subjects Who Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies|Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subjects seronegative before vaccination. Cut-off values assessed include 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.|At Month 7|Analysis was performed on initially seronegative subjects from the According-to-Protocol (ATP) cohort for analysis of immunogenicity.||Subjects|||Number
725160|NCT00344175|Secondary|Percent Change From Baseline in LDL-C||Baseline to 44 weeks|||percent change||Standard Deviation|Mean
725161|NCT00344175|Primary|Number of Patients Attaining NCEP LDL-C Target at Week 44|Number of patients attaining National Cholesterol Education Program (NCEP) LDL-C target at Week 44. According to NCEP criteria the target LDL-C is 100 mg/dL.|44 Weeks|||Participants|||Number
725162|NCT00344175|Primary|Number of Patients Attaining NCEP LDL-C Target at Week 16|Number of patients attaining the National Cholesterol Education Program (NCEP) LDL-C target at Week 16. According to NCEP criteria the target LDL-C is 100 mg/dL.|16 weeks|All patients who received at least 1 dose of study drug and who had at least 1 on-treatment (post Visit 1) lipid assessment.||particpants|||Number
725163|NCT00344305|Secondary|Number of Participants With REs in Relation to Any Vaccine Virus Shedding|REs were predefined solicited events that could potentially occur after vaccination. The REs for this study were fever, runny/stuffy nose, sore throat, cough, vomiting, headache, abdominal pain (stomach ache), muscle ache, chills, decreased activity level (lethargy), decreased appetite, and irritability.|Days 0-28 after study vaccination (up to Day 28)|Safety population included all participants who received any study drug and had experienced any follow-up for safety. Here, number of participants analyzed signified those participants who had REs.||participants|||Number
725164|NCT00344305|Secondary|Number of Participants With Serious Adverse Events (SAEs) and Significant New Medical Conditions (SNMC) Through 180 Days Post Vaccination|An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. An SNMC is defined as a newly diagnosed medical condition that was of a chronic, ongoing nature and was assessed by the investigator as medically significant. SNMCs included, but were not limited to, diabetes, asthma, autoimmune disease (lupus, rheumatoid arthritis), and neurological disease (epilepsy, autism).|Days 0-180 after vaccination (up to 6.5 months)|Safety population included all participants who received any study drug and had experienced any follow-up for safety.||participants|||Number
725165|NCT00344305|Secondary|Number of Participants With Reactogenicity Events (REs) and Adverse Events (AEs) Through 28 Days Post Vaccination|REs were predefined solicited events that could potentially occur after vaccination. The REs for this study were fever, runny/stuffy nose, sore throat, cough, vomiting, headache, abdominal pain (stomach ache), muscle ache, chills, decreased activity level (lethargy), decreased appetite, and irritability. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|Days 0-28 after vaccination (up to Day 28)|Safety population included all participants who received any study drug and had experienced any follow-up for safety.||participants|||Number
725166|NCT00344305|Secondary|Number of Participants With Genotypic and Phenotypic Stability of B Shed Vaccine Virus|The genetic and phenotypic stability of shed vaccine virus was evaluated by determination of genomic sequence and assessment of the ca and ts phenotypes. Viruses were considered ts if their titer at 37°C was at least two logs (100-fold) lower than their titer at 33°C. Viruses were considered ca if they replicated at 25°C to a titer that was no more than two logs (100-fold) lower than the titer at 33°C. After additional phenotypic and genotypic analyses, all evaluable samples retained the ca and ts phenotypes.|Days 1-28 after study vaccination (up to Day 28)|Shedding population: all participants who received a full dose of study drug and had assay results from nasal specimens obtained at any post-dosing time point. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified those participants who were evaluable for a specified category.||participants|||Number
725167|NCT00344305|Secondary|Number of Participants With Genotypic and Phenotypic Stability of A/H3N2 Shed Vaccine Virus|The genetic and phenotypic stability of shed vaccine virus was evaluated by determination of genomic sequence and assessment of the ca and ts phenotypes. Viruses were considered ts if their titer at 39°C was at least two logs (100-fold) lower than their titer at 33°C. Viruses were considered ca if they replicated at 25°C to a titer that was no more than two logs (100-fold) lower than the titer at 33°C. After additional phenotypic and genotypic analyses, all evaluable samples retained the ca and ts phenotypes.|Days 1-28 after study vaccination (up to Day 28)|Shedding population: all participants who received a full dose of study drug and had assay results from nasal specimens obtained at any post-dosing time point. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified those participants who were evaluable for a specified category.||participants|||Number
725168|NCT00344305|Secondary|Number of Participants With Genotypic and Phenotypic Stability of A/H1N1 Shed Vaccine Virus|The genetic and phenotypic stability of shed vaccine virus was evaluated by determination of genomic sequence and assessment of the cold-adapted (ca) and temperature-sensitive (ts) phenotypes. Viruses were considered ts if their titer at 39 degrees Celsius (°C) was at least two logs (100-fold) lower than their titer at 33°C. Viruses were considered ca if they replicated at 25°C to a titer that was no more than two logs (100-fold) lower than the titer at 33°C. After additional phenotypic and genotypic analyses, all evaluable samples retained the ca and ts phenotypes.|Days 1-28 after study vaccination (up to Day 28)|Shedding population: all participants who received a full dose of study drug and had assay results from nasal specimens obtained at any post-dosing time point. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified those participants who were evaluable for a specified category.||participants|||Number
725169|NCT00344305|Secondary|Quantitation of Confirmed B Shed Vaccine Virus on Any Day|Quantitation of confirmed B shed vaccine virus was evaluated using the log (TCID50)/mL for B vaccine strain and summarized for all participants who shed vaccine virus.|Days 1-28 after study vaccination (up to Day 28)|Shedding population included all participants who received a full dose of study drug and had assay results from nasal specimens obtained at any post-dosing time point. Here, number of participants analyzed signified those participants who shed any confirmed strain virus.||log (TCID50)/mL||Standard Deviation|Mean
725170|NCT00344305|Secondary|Quantitation of Confirmed A/H3N2 Shed Vaccine Virus on Any Day|Quantitation of confirmed A/H3N2 shed vaccine virus was evaluated using the log (TCID50)/mL for A/H3N2 vaccine strain and summarized for all participants who shed vaccine virus.|Days 1-28 after study vaccination (up to Day 28)|Shedding population included all participants who received a full dose of study drug and had assay results from nasal specimens obtained at any post-dosing time point. Here, number of participants analyzed signified those participants who shed any confirmed strain virus.||log (TCID50)/mL||Standard Deviation|Mean
725171|NCT00344305|Secondary|Quantitation of Confirmed A/H1N1 Shed Vaccine Virus on Any Day|Quantitation of confirmed A/H1N1 shed vaccine virus was evaluated using the log transformed median tissue culture infectious dose (TCID50) per (/) millilitre (mL) for A/H1N1 vaccine strain and summarized for all participants who shed vaccine virus.|Days 1-28 after study vaccination (up to Day 28)|Shedding population included all participants who received a full dose of study drug and had assay results from nasal specimens obtained at any post-dosing time point. Here, number of participants analyzed signified those participants who shed any confirmed strain virus.||log (TCID50)/mL||Standard Deviation|Mean
725172|NCT00344305|Secondary|Duration of Confirmed B Vaccine Virus Shedding|The number of days of shedding was summarized for all participants who shed confirmed B strain virus.|Days 1-28 after study vaccination (up to Day 28)|Shedding population included all participants who received a full dose of study drug and had assay results from nasal specimens obtained at any post-dosing time point. Here, number of participants analyzed signified those participants who shed any confirmed strain virus.||days||Standard Deviation|Mean
725173|NCT00344305|Secondary|Duration of Confirmed A/H3N2 Vaccine Virus Shedding|The number of days of shedding was summarized for all participants who shed confirmed A/H3N2 strain virus.|Days 1-28 after study vaccination (up to Day 28)|Shedding population included all participants who received a full dose of study drug and had assay results from nasal specimens obtained at any post-dosing time point. Here, number of participants analyzed signified those participants who shed any confirmed strain virus.||days||Standard Deviation|Mean
725174|NCT00344305|Secondary|Duration of Confirmed A/H1N1 Vaccine Virus Shedding|The number of days of shedding was summarized for all participants who shed confirmed A/H1N1 strain virus.|Days 1-28 after study vaccination (up to Day 28)|Shedding population included all participants who received a full dose of study drug and had assay results from nasal specimens obtained at any post-dosing time point. Here, number of participants analyzed signified those participants who shed any confirmed strain virus.||days||Standard Deviation|Mean
725175|NCT00344305|Secondary|Duration of Any Vaccine Virus Shedding|The number of days of shedding was summarized for all participants who shed any vaccine virus.|Days 1-28 after study vaccination (up to Day 28)|Shedding population included all participants who received a full dose of study drug and had assay results from nasal specimens obtained at any post-dosing time point. Here, number of participants analyzed signified those participants who shed any confirmed strain virus.||days||Standard Deviation|Mean
725176|NCT00344305|Primary|Percentage of Participants Who Shed B Vaccine Virus|Viral shedding is defined as the detection of virus by viral culture and vaccine-type virus was confirmed by PCR based assays. Viral shedding (A/New Caledonia/20/99 [H1N1]; A/Wyoming/03/2003 [H3N2] (A/Fujian/411/2002-like); B/Jilin/20/2003 B/Shanghai/361/2002-like]) was measured from samples obtained from nasal swabs daily from Days 1 to 7 post vaccination and approximately every other day thereafter from Days 9 to 28. Participants whose Day 25 or 28 shedding sample was positive for vaccine virus had additional shedding samples collected approximately every 7 days, or as soon as possible upon awareness of culture positivity, until 2 consecutive samples were negative for vaccine virus.|Days 1-28 after study vaccination (up to Day 28)|Shedding population included all participants who received a full dose of study drug and had assay results from nasal specimens obtained at any post-dosing time point. Here, number of participants analyzed signified those participants who were evaluable for this outcome.||percentage of participants||95% Confidence Interval|Number
725188|NCT00351039|Secondary|One-year Survival(1-year S)|Secondary Objective: One-year survival(1-year S) in patients with advanced NSCLC treated with this regimen.|26 Months|Had the study been completed as planned we would have measured the One-year Survival. This study was closed early due to poor accrual.|||||
725177|NCT00344305|Primary|Percentage of Participants Who Shed A/H3N2 Vaccine Virus|Viral shedding is defined as the detection of virus by viral culture and vaccine-type virus was confirmed by PCR based assays. Viral shedding (A/New Caledonia/20/99 [H1N1]; A/Wyoming/03/2003 [H3N2] (A/Fujian/411/2002-like); B/Jilin/20/2003 B/Shanghai/361/2002-like]) was measured from samples obtained from nasal swabs daily from Days 1 to 7 post vaccination and approximately every other day thereafter from Days 9 to 28. Participants whose Day 25 or 28 shedding sample was positive for vaccine virus had additional shedding samples collected approximately every 7 days, or as soon as possible upon awareness of culture positivity, until 2 consecutive samples were negative for vaccine virus.|Days 1-28 after study vaccination (up to Day 28)|Shedding population included all participants who received a full dose of study drug and had assay results from nasal specimens obtained at any post-dosing time point. Here, number of participants analyzed signified those participants who were evaluable for this outcome.||percentage of participants||95% Confidence Interval|Number
725178|NCT00344305|Primary|Percentage of Participants Who Shed A/H1N1 Vaccine Virus|Viral shedding is defined as the detection of virus by viral culture and vaccine-type virus was confirmed by PCR based assays. Viral shedding (A/New Caledonia/20/99 [H1N1]; A/Wyoming/03/2003 [H3N2] (A/Fujian/411/2002-like); B/Jilin/20/2003 B/Shanghai/361/2002-like]) was measured from samples obtained from nasal swabs daily from Days 1 to 7 post vaccination and approximately every other day thereafter from Days 9 to 28. Participants whose Day 25 or 28 shedding sample was positive for vaccine virus had additional shedding samples collected approximately every 7 days, or as soon as possible upon awareness of culture positivity, until 2 consecutive samples were negative for vaccine virus.|Days 1-28 after study vaccination (up to Day 28)|Shedding population included all participants who received a full dose of study drug and had assay results from nasal specimens obtained at any post-dosing time point. Here, number of participants analyzed signified those participants who were evaluable for this outcome.||percentage of participants||95% Confidence Interval|Number
725179|NCT00344305|Primary|Percentage of Participants Who Shed Any Vaccine Virus|Viral shedding is defined as the detection of virus by viral culture and vaccine-type virus was confirmed by polymerase chain reaction (PCR) based assays. Viral shedding (A/New Caledonia/20/99 [H1N1]; A/Wyoming/03/2003 [H3N2] (A/Fujian/411/2002-like); B/Jilin/20/2003 B/Shanghai/361/2002-like]) was measured from samples obtained from nasal swabs daily from Days 1 to 7 post vaccination and approximately every other day thereafter from Days 9 to 28. Participants whose Day 25 or 28 shedding sample was positive for vaccine virus had additional shedding samples collected approximately every 7 days, or as soon as possible upon awareness of culture positivity, until 2 consecutive samples were negative for vaccine virus.|Days 1-28 after study vaccination (up to Day 28)|Shedding population included all participants who received a full dose of study drug and had assay results from nasal specimens obtained at any post-dosing time point. Here, number of participants analyzed signified those participants who were evaluable for this outcome.||percentage of participants||95% Confidence Interval|Number
725180|NCT00344370|Secondary|Percent Change From Baseline in LDL-C|Percent change from baseline in LDL-C at 44 weeks|Basseline to 44 weeks|||percent change||Standard Deviation|Mean
725181|NCT00344370|Primary|NCEP LDL-C Target Attainment|Number of patients attaining National Cholesterol Education Program (NCEP) LDL-C target at 44 weeks. According to NCEP criteria the target LDL-C is 100 mg/dL for all patients in this study.|44 weeks|The efficacy population is defined as all patients who received at least one dose of study drug and who had at least one on-treatment lipid assessment||Participants|||Number
725182|NCT00344448|Primary|Response Rate at the End of the First (Blinded, Placebo Controlled) Phase at 12 Weeks|"Patient will be considered a responder if (s)he demonstrates improvement in 2 / 3 disease activity measures without worsening of the third one.
Salivary flow: 0.45 ml / 15 min improvement in unstimulated whole salivary flow from baseline value obtained at the study entry.
Salivary gland biopsy:
at least 2 points improvement in the focus score on MSG biopsy
Tear flow:
at least 30% improvement in ophthalmic Oxford grading scheme or normalization of the scale as defined by score of 0 or 2mm improvement in Schirmer test as compared with the baseline in either eye."|3 months|||participant|||Number
725183|NCT00351039|Secondary|Overall Survival (Median Survival [MS])|Secondary Objective: Determine the Overall Survival (median survival[MS]) in patients with advanced NSCLC treated with this regimen. Patients were to be followed until death and survival curves were to be generated.|26 Months|Had the study been completed as planned we would have measured Overall Survival described as Median Survival. This study was closed early due to poor accrual.|||||
725184|NCT00351039|Primary|Progression Free Survival (PFS)|The primary objective was to determine the progression free survival (PFS), in newly diagnosed patients with advanced Non Small Cell Lung Cancer (NSCLC) who are treated with a regimen consisting of Bevacizumab(B), pemetrexed(A), and erlotnib(T). This was a Phase I/II study. This trial was halted after the Phase I component was completed. The Phase II component was never initiated.|26 months|No patients proceeded to Phase II for evaluation.|||||
725185|NCT00351039|Secondary|Number of Participants With Grade 3 and Grade 4 Adverse Events|By Safety, the intent was to capture, tabulate, list all of the grade 3 and 4 adverse effects seen by this protocol. For each toxicity, we followed the Common Toxicity Criteria(NCI CTC)Version 2.0 Toxicity scale guidelines.|26 Months|This study was initially intended to be a Phase I/II study with a brief Phase I Run-in. After the brief Phase I Run-in the study was closed without initiating the Phase II component.||Participants|||Number
725186|NCT00351039|Secondary|Quality of Life (QOL)|"The Scales we were intending to use were:
Instrumental Activities of Daily Living (IADL): Range of Scale 0 (Best) to 8 (Worst).
Cumulative Illness Rating Scale-Geriatric (CIRS-G): Range of Scores 1(Best) to 18 (Worst).
Functional Assessment of Cancer Therapy-Lung (FACT-L): Range of Scores 0 (Best) to 48 (Worst).
Fatigue Symptom Inventory (FSI): Range of Scores 0(Best) to 121 (Worst).
Each scale would have been evaluated independently. Since the study was not completed and closed early due to poor accrual, none of the QOL parameters were analyzed."|26 Months|Since no patients were accrued to the Phase II component of the trial, 0 patients were analyzed for these scales.|||||
725187|NCT00351039|Secondary|Number of Patients Who Responded to Treatment|"Phase I:
Response Evaluation Criteria In Solid Tumors (RECIST)Criteria was used for Response. Partial Response (PR) is defined as at least a 30% decrease in the sum of Longest Dimention (LD) of target lesions taking as reference the baseline sum LD."|26 Months|8 patients were accrued to the Phase I component of the trial. No patients were accrued to the Phase II component of the trial.|||||
725189|NCT00351273|Secondary|Number of Patients With a Complete Response (Resolution of All Symptoms)||Months 1, 3, 6 and 9||||||
725197|NCT00351273|Primary|Investigate Whether a 6 Month Course of Combined Antibiotics Was Effective Treatment.|The outcome measure was a composite endpoint. Participants had to meet 4/6 clinical criteria. 17/24 subjects randomized to combination antibiotics did respond to treatment when compared to 3/10 randomized to placebo.|Month 6|Efficacy and safety analyses were performed on an intent to treat(ITT) basis. Subjects who prematurely withdrew or who were lose to follow up for any reason were included in the ITT population and were considered nonresponders.||participants|||Number
725198|NCT00351299|Secondary|In-hospital Mortality|Did patient die while in the hospital? (Yes/No)|Patients will remain in the study for up to 7 days after development of delirium or discharge from ICU whichever is earlier, up to study end|||Participants|||Count of Participants
725199|NCT00351299|Secondary|Ease of Management for the Nursing Staff|"Subjective measure rating 3 categories for ease of management:
Mostly easy
Easy to manage 75% of the time
Not easy to manage"|Up to initial 48 hours|||Participants|||Count of Participants
725200|NCT00351299|Secondary|Length of Intensive Care Unit (ICU) Stay|Number of days intensive care unit (ICU) stay|Patients will remain in the study for up to 7 days after development of delirium or discharge from ICU whichever is earlier, up to study end|||days||Inter-Quartile Range|Median
725201|NCT00351299|Secondary|Length of Ventilator Support|Number of days on mechanical ventilation|Patients will remain in the study for up to 7 days after development of delirium or discharge from ICU whichever is earlier, up to study end|||days||Inter-Quartile Range|Median
725202|NCT00351299|Primary|Resolution of Delirium|"Resolution of delirium as defined by 2 consecutive negative CAM-ICU assessments.
The Confusion Assessment Method for the ICU (CAM-ICU). The CAM-ICU assesses the four features of delirium: feature 1 is an acute change in mental status or a fluctuating mental status, feature 2 is inattention, feature 3 is altered level of consciousness, and feature 4 is disorganized thinking."|Up to 7 days|||Participants|||Count of Participants
725203|NCT00351468|Secondary|Best Post-Baseline Change in the FACT-TH6 at Any Time Point Compared to Baseline|The FACT-TH6 consists of 6 questions in which patients rate (0-4) their general degree of worry related to bleeding and bruising, and resulting activity impairment and frustration. Although the six items do not constitute a formal domain or subscale of the FACT‑Th assessment tool, these items had been identified by focus groups of patients with chronic ITP as important indicators of their HRQoL. Items were reverse-scored as necessary such that higher scores represent higher HRQoL. Total scores ranged from 0 to 24. Recall period is not specified. The change in scores was measured at the transitioning period and immediately prior to withdrawal/completion over 2 years, and the mean of these measurements was recorded to calculate the change from baseline and the best post baseline change score was reported for the entire group|Baseline, beginning of each stage, change in therapy and minimum frequency of every 3 months during stages, prior to early discontinuation, up to 2 years|||Points on a scale||95% Confidence Interval|Mean
725204|NCT00351468|Secondary|Best Post-Baseline Change in the FACIT-Fatigue 13 Item Subscale Score From Any Time Point Compared to Baseline|"The FACIT-Fatigue consists of 13 questions in which patients rate the frequency (0-4) of symptoms of fatigue, in terms of tiredness, weakness, and fatigue Items were reverse-scored as necessary such that higher scores represent higher HRQoL Total score ranges from 0 to 52.Using anchor-based estimates, the minimally important difference in this subscale is 3.0 points.
Recall period is past week prior to administration. The change in scores was measured at the transitioning period and immediately prior to withdrawal/completion over 2 years, and the mean of these measurements was recorded to calculate the change from baseline and the best post baseline change score was reported for the entire group"|Baseline, beginning of each stage, change in therapy and minimum frequency of every 3 months during stages, prior to early discontinuation, up to 2 years|ITT||Points on a scale||95% Confidence Interval|Mean
725205|NCT00351468|Secondary|Best Post-Baseline Change in the Short Form of the Motivation and Energy Scale (MEI-SF) From Any Time Point Compared With Baseline|The MEI-SF (18 questions) was used to measure the reductions in mental energy, physical energy, and social motivation, either as symptoms of chronic ITP or as a side effect of pharmacotherapy. Minimal clinically important differences are estimated as 0.5 standard deviations or 7.5 points. All items use either a 7-level (0 to 6) or 5-level (0 to 4) response scale; items with a 5-level response scale were rescaled to 7-levels, and items were reverse-scored as necessary such that higher scores represent higher HRQoL Total score ranges from 0 to 108 points. Recall period is past week prior to administration. The change in scores was measured at the transitioning period and immediately prior to withdrawal/completion over 2 years, and the mean of these measurements was recorded to calculate the change from baseline and the best post baseline change score was reported for the entire group|Baseline, beginning of each stage, change in therapy and minimum frequency of every 3 months during stages, prior to early discontinuation, up to 2 years|||Points on a scale||95% Confidence Interval|Mean
725206|NCT00351468|Secondary|Best Post-Baseline Change in SF-36v2 Questionnaire Score From Any Time Point Compared With Baseline|The SF-36v2 assessment tool was used to obtain information about subjects’ general health status and health-related quality of life. Until a formal assessment of minimal clinically important differences (MCID) is performed, changes from baseline of more than 0.5 standard deviations are suggested as clinically meaningful. Scores were transformed to a 0-100 point scale, with higher scores representing more positive answers. Scores were normalized to have a mean of 50 and SD of 10 to allow for comparison with outcomes from other chronic diseases. Recall period is the past week prior to administration. The change in scores was measured at the transitioning period and immediately prior to withdrawal/completion over 2 years, and the mean of these measurements was recorded to calculate the change from baseline and the best post baseline change score was reported for the entire group|Baseline, beginning of each stage, change in therapy and minimum frequency of every 3 months during stages, prior to early discontinuation, up to 2 years|||Points on a scale||95% Confidence Interval|Mean
725207|NCT00351468|Secondary|Maximum ITP Bleeding Score at Any Time During the Study During All Stages.|The ITP bleeding score is a tool which has been designed specifically to assess the bruising and bleeding in patients with ITP across body sites, ranging from mild to severe. The WHO Grades were dichotomized into the following categories: - Grade 0, No bleeding -Grade 1 to 4, Any bleeding -Grade 0 to 1: No clinically significant bleeding -Grade 2 to 4 Clinically significant bleeding|Baseline up to 2 years|||Participants|||Number
725227|NCT00351533|Secondary|ICU-free Days During First 28 Days After Study Enrollment|ICU-free days is a common outcome measure in critical care research. An ICU-free day is a day that a participant is alive and not in the intensive care unit (ICU) during the first 28 days after s/he enrolled in the study.|28 days|||Days||Standard Deviation|Mean
725208|NCT00351468|Secondary|Number of Subjects Who Required Rescue Therapy During Treatment With Eltrombopag.|Rescue treatment is defined as a composite of: new ITP medication, increased dose of a concomitant ITP medication, platelet transfusion, and splenectomy. Subjects may have received more than 1 type of rescue therapy|Baseline up to 2 years|||Participants|||Number
725209|NCT00351468|Secondary|Number of Participants With Reduction and/or Sparing of Concomitant ITP Therapies, While Maintaining a Platelet Count ≥ 50,000/mL.|Sustain reduct: Sustained reduction 1 Denominator is number of subjects taking an ITP medication at baseline. 2 Denominator is number of subjects with a sustained reduction. Note: Sustained reduction defined as reduction from baseline in dose and/or frequency which is maintained for at least 4 weeks. Excludes sustained reductions started more than 1 day after last dose.|Baseline up to 2 years|||Participants|||Number
725210|NCT00351468|Secondary|Number of Subjects Who Responded to Eltrombopag in a Previous Study and Who Respond to Retreatment With a Rise in Platelet Count to Either ≥ 50,000/µL or ≥30,000/µL|Responder in TRA100773: Platelet count 50 Gi/L and 2 x baseline (BL) at last on-treatment assessment. Responders in EXTEND: Platelet count 50 Gi/L and 2 x baseline (BL), 50 Gi/L, and 30 Gi/L at any time. Responder in RAISE: Platelet count 50GI/L and 2 x baseline at Week 6 assessment. Responders in EXTEND: Platelet count 50 Gi/L and 2 x baseline, 50 Gi/L, and 30 Gi/L at any time. Responder in REPEAT: Platelet count 50 GI/L and 2 x baseline (BL) at Week 6 assessment in Cycle 1. Responders in EXTEND: Platelet count 50 Gi/L and 2 x baseline (BL) 50 Gi/L, and 30 Gi/L at any time.|Baseline up to 2 years|ITT||Participants|||Number
725211|NCT00351468|Secondary|Summary of Subjects Achieving Platelet Count Levels by Week, in the Absence of Rescue Medication|"If a subject has more than 1 platelet count result within a week, the lowest value observed is used to determine response. All platelet counts after an on-study splenectomy are not classed as responses. Platelet counts within 7 days after a platelet transfusion are not classed as responses.
Platelet counts while taking an increased ITP medication or within 6 weeks after the end of an increased ITP medication are not classed as responses."|Baseline up to Year 7/Week 364|ITT population||Participants|||Number
725212|NCT00351468|Secondary|Subjects Achieving Maximum Platelet Counts Greater Than or Equal to 30 Gi/L or 50 Gi/L in the Absence of Rescue Medication|"Subjects who achieved maximum platelet count at least once during treatment. All platelet counts after an on-study splenectomy are not classed as responses.
Platelet counts within 7 days after a platelet transfusion are not classed as responses.
Platelet counts while taking an increased ITP medication or within 6 weeks after the end of an increased ITP medication are not classed as responses."|Baseline up to 2 years|ITT population||Participants|||Number
725213|NCT00351468|Primary|Overall Summary of On-Therapy Adverse Events (Safety Population)|All safety evaluation findings considered to be adverse events are reported in the Adverse Event section.|Start date was the first dose of investigational product and up to the day after the last dose . Post-therapy: start date was more than 1 day after the last dose and up to 30 days after last dose of investigational product up to week 364|||Participants|||Number
725214|NCT00351533|Secondary|Change in Plasma vonWillebrand Factor|15 patients in the fish oil group and 27 patients in the enteral saline group underwent 3rd blood draw on day 9. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 9|||pg/mL||Inter-Quartile Range|Median
725215|NCT00351533|Secondary|Change in Plasma Surfactant Protein D|15 patients in the fish oil group and 27 patients in the enteral saline group underwent 3rd blood draw on day 9. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 9|||pg/mL||Inter-Quartile Range|Median
725216|NCT00351533|Secondary|Change in Plasma Interleukin-6|15 patients in the fish oil group and 27 patients in the enteral saline group underwent 3rd blood draw on day 9. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 9|||pg/mL||Inter-Quartile Range|Median
725217|NCT00351533|Secondary|Change in Plasma Leukotriene B4|15 patients in the fish oil group and 27 patients in the enteral saline group underwent 3rd blood draw on day 9. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 9|||pg/mL||Inter-Quartile Range|Median
725218|NCT00351533|Secondary|Change in Plasma Interleukin-8|15 patients in the fish oil group and 27 patients in the enteral saline group underwent 3rd blood draw on day 9. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 9|||pg/mL||Inter-Quartile Range|Median
725219|NCT00351533|Secondary|Change in BALF Neutrophil Count|15 patients in the fish oil group and 27 patients in the enteral saline group underwent the 3rd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 9|||# of cells/mm^3||Inter-Quartile Range|Median
725220|NCT00351533|Secondary|Change in BALF Monocyte Chemotactic Protein-1|15 patients in the fish oil group and 27 patients in the enteral saline group underwent the 3rd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 9|||pg/mL||Inter-Quartile Range|Median
725221|NCT00351533|Secondary|Change in BALF Interleukin-6|15 patients in the fish oil group and 27 patients in the enteral saline group underwent the 3rd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 9|||pg/mL||Inter-Quartile Range|Median
725222|NCT00351533|Secondary|Change in BALF Leukotriene B4|15 patients in the fish oil group and 27 patients in the enteral saline group underwent the 3rd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 9|||pg/mL||Inter-Quartile Range|Median
725223|NCT00351533|Secondary|Change in Bronchoalveolar Lavage Fluid (BALF) Interleukin (IL)-8|15 patients in the fish oil group and 27 patients in the enteral saline group underwent the 3rd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 9|||pg/mL||Inter-Quartile Range|Median
725224|NCT00351533|Secondary|60-day Mortality||60 days from day of enrollment into study|||Participants|||Number
725228|NCT00351533|Secondary|Ventilator-free Days During First 28 Days After Study Enrollment|Ventilator-free days is a common outcome measure in critical care research. A ventilator-free day is a day that a participant is alive and not receiving mechanical ventilation during the first 28 days after s/he enrolled in the study.|28 days|||Days||Standard Deviation|Mean
725229|NCT00351533|Secondary|Worst Multiple Organ Dysfunction Score (MODS) During First 28 Days After Study Enrollment|"Full scale name is Multiple Organ Dysfunction Score (MODS), a scale measuring degree of organ dysfunction in critically ill patients.
Minimum score is 0 and maximum score is 24, with 0 indicating no organ failure and 24 indicating severe failure of multiple organs."|Throughout hospital stay|||Scores on a scale||Standard Deviation|Mean
725230|NCT00351533|Secondary|Change in Plasma vonWillebrand Factor|30 patients in the fish oil group and 36 patients in the enteral saline group underwent 2nd blood draw on day 5. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 5|||pg/mL||Inter-Quartile Range|Median
725231|NCT00351533|Secondary|Change in Plasma Surfactant Protein D|30 patients in the fish oil group and 36 patients in the enteral saline group underwent 2nd blood draw on day 5. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 5|||pg/mL||Inter-Quartile Range|Median
725232|NCT00351533|Secondary|Change in Plasma Interleukin-6|30 patients in the fish oil group and 36 patients in the enteral saline group underwent 2nd blood draw on day 5. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 5|||pg/mL||Inter-Quartile Range|Median
725233|NCT00351533|Secondary|Change in Plasma Leukotriene B4|30 patients in the fish oil group and 36 patients in the enteral saline group underwent 2nd blood draw on day 5. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 5|||pg/mL||Inter-Quartile Range|Median
725234|NCT00351533|Secondary|Change in Plasma Interleukin-8|30 patients in the fish oil group and 36 patients in the enteral saline group underwent 2nd blood draw on day 5. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 5|||pg/mL||Inter-Quartile Range|Median
725235|NCT00351533|Secondary|Oxygenation|PaO2/FiO2 is the ratio of partial pressure of arterial oxygen to the fraction of inspired oxygen. 30 patients in the fish oil group and 36 patients in the enteral saline group remained intubated on day 5 and had this outcome available.|Day 5|||PaO2/FiO2||Standard Deviation|Mean
725236|NCT00351533|Secondary|Static Lung Compliance|30 patients in the fish oil group and 36 patients in the enteral saline group remained intubated on day 5 and had this outcome available.|Day 5|||L/cm H20||Standard Deviation|Mean
725237|NCT00351533|Secondary|Change in BALF Neutrophil Count|30 patients in the fish oil group and 36 patients in the enteral saline group underwent the 2nd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 5|||# of cells/mm^3||Inter-Quartile Range|Median
725238|NCT00351533|Secondary|Change in BALF Monocyte Chemotactic Protein-1|30 patients in the fish oil group and 36 patients in the enteral saline group underwent the 2nd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 5|||pg/mL||Inter-Quartile Range|Median
725239|NCT00351533|Secondary|Change in BALF Interleukin-6|30 patients in the fish oil group and 36 patients in the enteral saline group underwent the 2nd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 5|||pg/mL||Inter-Quartile Range|Median
725240|NCT00351533|Secondary|Change in BALF Leukotriene B4|30 patients in the fish oil group and 36 patients in the enteral saline group underwent the 2nd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 5|||pg/mL||Inter-Quartile Range|Median
725241|NCT00351533|Primary|Change in Bronchoalveolar Lavage Fluid (BALF) Interleukin (IL)-8|30 patients in the fish oil group and 36 patients in the enteral saline group underwent the 2nd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 5|The primary outcome was >=50% reduction in BALF IL-8, measured as the change from baseline to day 5. With α=0.05 and β=0.2, we calculated that 26 patients per group were needed if participants underwent two BALs. Analysis was intention to treat (ITT).||pg/mL||Inter-Quartile Range|Median
725242|NCT00351741|Secondary|Ventilator Associated Tracheobronchitis (VATB)|Defined as carinal or mainstem airway friability and sloughing with associated bleeding. Only diagnosed after the patient had spent at least 7 days on the assigned ventilator mode and had not been diagnosed with inhalation injury on admission|checked daily|||Participants|||Number
725243|NCT00351741|Secondary|Barotrauma|Defined as a new pneumothorax, pneumomediastinum, subcutaneous emphysema, interstitial emphysema, or pneumatocele >2 cm in diameter not associated with a vascular procedure, lung biopsy, or thoracentesis.|28 days|||Participants|||Number
725244|NCT00351741|Secondary|Need for Rescue Ventilator|Subjects who did not meet predetermined oxygenation and ventilation goals on the study mode despite ventilator- specific optimization were switched to a rescue mode of ventilation.|28 days|||Participants|||Number
725245|NCT00351741|Secondary|Ventilator Associated Pneumonia|Those who develop both clinical and microscopic evidence of pulmonary infection while on the ventilator.|28 days|||Participants|||Number
725246|NCT00351741|Secondary|Death|In-hospital death.|during hospitalization|||Participants|||Number
725247|NCT00351741|Secondary|Days Free From Nonpulmonary Organ Failure|days free from nonpulmonary organ failure as adapted from the ARDSnet study in the first 28 days.|28|||Days||Standard Deviation|Mean
725248|NCT00351741|Primary|Ventilator-free Days During the First 28 Days|The primary end point was ventilator-free days in the first 28 days, defined as the number of days after randomization from day 0 to day 28 alive without ventilator assistance for at least 48 consecutive hrs.|28 days|||Days||Standard Deviation|Mean
725249|NCT00351819|Other Pre-specified|Insomnia Severity Index (ISI) at Week 14|ISI is comprised of 7 items assesses a participant's perception of insomnia. Each item is rated on a 5-point scale from 0 (none) to 4 (very severe). Scores from the questions are summed to assign a total score ranging from 0 to 28, where higher score represents worse insomnia problem.|Week 14 after intervention|All available data expressed as absolute values at week 14.||units on a scale||Standard Deviation|Mean
725250|NCT00351819|Other Pre-specified|C-reactive Protein (CRP) at Week 14|High-sensitivity C-reactive protein (Alpco Diagnostics) was measured using a high-sensitivity sandwich ELISA with an intra-assay CV of 5.6%|Week 14 after intervention|All available data expressed as absolute values at week 14.||mg/L||Standard Deviation|Mean
725251|NCT00351819|Other Pre-specified|Leptin at Week 14|Leptin levels were measured using ELISA with an interassay CV of 2.6% to 6.2% and in intra-assay CV of 2.6% to 4.6% (Millipore, Billerica, MA, USA).|Week 14 after intervention|All available data expressed as absolute values at week 14.||ug/L||Standard Deviation|Mean
725252|NCT00351819|Other Pre-specified|Adiponectin at Week 14|Total adiponectin was measured using an RIA kit with an interassay CV of 6.9-9.3% and an intra-assay CV of 1.8-6.2% (Millipore).|Week 14 after intervention|All available data expressed as absolute values at week 14.||ug/mL||Standard Deviation|Mean
725253|NCT00351819|Other Pre-specified|HOMA IR Score at Week 14|Insulin resistance was calculated using the homeostatic model assessment (HOMA) index: glucose * insulin / 22.5.|Week 14 after intervention|All available data expressed as absolute values at week 14.||HOMA IR score||Standard Deviation|Mean
725254|NCT00351819|Other Pre-specified|Insulin Level in Oral Glucose Tolerance Test (OGTT) at Week 14|All participants underwent 75-g oral glucose tolerance test (OGTT) after a 12-h fast, The insulin level were analyzed at baseline and at 60 and 120 min after glucose loading.|Values at week 14 after intervention|All available data expressed as absolute values at week 14.||pmol/L||Standard Deviation|Mean
725255|NCT00351819|Other Pre-specified|Glucose Level in Oral Glucose Tolerance Test (OGTT) at Week 14|All participants underwent 75-g oral glucose tolerance test (OGTT) after a 12-h fast, The plasma glucose level were analyzed at baseline and at 60 and 120 min after glucose loading.|Week 14 after intervention|All available data expressed as absolute values at week 14.||mmol/L||Standard Deviation|Mean
725256|NCT00351819|Other Pre-specified|HbA1c at Week 14||Week 14 after intervention|All available data expressed as absolute values at week 14.||percentage of glycosylated hemogobin||Standard Deviation|Mean
725257|NCT00351819|Other Pre-specified|Lipid Profile at Week 14|Serum total cholesterol, triglycerides and high-density lipoprotein (HDL) cholesterol levels were measured by enzymatic assays and standardized to the CDC using the Lipid Research Clinic protocol. Low-density lipoprotein (LDL) cholesterol was calculated using the Friedewald equation.|Week 14 after intervention|All available data expressed as absolute values at week 14.||mmol/L||Standard Deviation|Mean
725258|NCT00351819|Other Pre-specified|Body Composition at Week 14|Body composition was measured using dual-energy X-ray absorptiometry scan.|Week 14 after intervention|All available data expressed as absolute values at week 14.||kg||Standard Deviation|Mean
725259|NCT00351819|Other Pre-specified|Inflammatory Cytokines at Week 14|The pathophysiology of pain is measured by the proinflammatory cytokines interleukin-6 (IL-6) and tumor necrosis factor alpha (TNF-Alpha).|Week 14 after intervention|All available data expressed as absolute values at week 14.||pg/mL||Standard Deviation|Mean
725260|NCT00351819|Other Pre-specified|Luteinizing Hormone Values at Week 14|Luteinizing hormone was measured using immunofluorometric assays, with limits of quantification of 0.05 U/L.|Week 14 after intervention|All available data expressed as absolute values at week 14.||U/L||Standard Deviation|Mean
725261|NCT00351819|Other Pre-specified|Sex Hormone Binding Globulin (SHBG) at Week 14|Sex hormone binding globulin was measured using immunofluorometric assays, with limits of quantification of 2.5 nmol/L.|Week 14 after intervention|All available data expressed as absolute values at week 14.||nmol/L||Standard Deviation|Mean
725262|NCT00351819|Other Pre-specified|Free Testosterone Values at Week 14|Free testosterone was calculated using a law of mass action equation.|Week 14 after intervention|All available data expressed as absolute values at week 14.||pg/mL||Standard Deviation|Mean
725263|NCT00351819|Other Pre-specified|Total Testosterone Values at Week 14|Total testosterone was measured in a CDC-certified laboratory using an LC-MS/MS method with a sensitivity of 2 ng/dL.|Week 14 after intervention|All available data expressed as absolute values at week 14.||ng/dL||Standard Deviation|Mean
725264|NCT00351819|Secondary|Pain Catastrophizing Scale (PCS) at Week 14|PCS questionnaire measures self-assessment of pain catastrophizing. This questionnaire consists of 13 items on past painful experiences and rate on 5-point scales ranging from 0 (not at all) to 4 (all the time). The PCS yields three subscale scores assessing rumination (range 0-16), magnification (range 0-12), helplessness (range 0-24), and a composite score (sum of three domains, ranging 0-52). Higher score represents worse painful experiences.|Values at week 14 after intervention|All available data expressed as absolute values at week 14.||units on a scale||Standard Deviation|Mean
725265|NCT00351819|Secondary|Health Quality of Life (QoL) as Assessed by Short Form 36 (SF-36) at Week 14|The SF-36 measures 8 domains of the QoL: physical function, bodily pain, vitality, role limitations due to physical problems, general health perceptions, emotional well-being, social function, and role limitations due to emotional problems. Each domain is scored separately from 0 to 100 with higher scores representing better health-related QoL.|Week 14 after intervention|All available data expressed as absolute values at week 14.||units on a scale||Standard Deviation|Mean
725266|NCT00351819|Secondary|Sexual Functioning as Assessed by International Index of Erectile Function (IIEF) at Week 14|IIEF is a validated, 15-item questionnaire that assesses 5 domains of sexual function: erectile function (range 1-30), orgasmic function (range 0-10), sexual desire (range 2-10), intercourse satisfaction (range 0-15), and overall sexual satisfaction (range 2-10). Each question was answered on a 6-point or 5-point scale from 0/1 to 5 (best) with a total possible score (sum of 5 domains) range of 5 to 75 with higher scores representing better function.|Week14 after intervention|All available data expressed as absolute values at week 14.||units on a scale||Standard Deviation|Mean
725267|NCT00351819|Primary|Ice Water-induced Cold Pain and Its After-sensation at Week 14|Cold-pressor tests measure cold-induced pain and its sensation. Time was measured when a participant reached pain tolerance in cold water and after sensation. Higher values of time in Cold pain tolerance and lower values of time in Cold pain after-sensation (30 seconds) represent better tolerance of pain.|Week 14 after intervention|||seconds||Standard Deviation|Mean
725269|NCT00351819|Primary|Algometer-induced Pressure Pain at Week 14|A digital pressure algometer at the trapezius muscle and the metacarpophalangeal joint of the thumb was used to measure pressure pain thresholds. Higher values represent a better tolerance of pressure pain.|Week 14 after intervention|||kPa/cm2||Standard Deviation|Mean
725270|NCT00351819|Primary|Brief Pain Inventory (BPI) at Week 14|BPI is a self-administered questionnaire that measuring chronic pain. BPI gives two main scores: a pain severity score and a pain interference score. The pain severity score assesses the severity of pain on a continuous scale from 0 (no pain) to 10 (severe pain). The pain interference score corresponds to the item on pain interference, ranging from 0 (does not interfere) to 10(completely interferes). The total score is the sum of the pain severity score and pain interference score, ranging from 0(no pain) to 20 (severe and completely interfered pain).|Week14 after intervention|All available data expressed as absolute values at week 14.||units on a scale||Standard Deviation|Mean
725271|NCT00351936|Primary|Change From Baseline in Triglycerides|Evaluating change in triglyceride levels between Baseline and Week 4, comparing subjects treated with aripiprazole for 4 weeks to subjects treated with placebo for 4 weeks.|baseline, week 4|||mg/dL||Standard Deviation|Mean
725272|NCT00351936|Primary|Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)|Evaluating change in high-density lipoprotein cholesterol (HDL-C) between Baseline and Week 4, comparing subjects treated with aripiprazole for 4 weeks to subjects treated with placebo for 4 weeks.|baseline, week 4|||mg/dL||Standard Deviation|Mean
725273|NCT00351936|Primary|Change From Baseline in Low-density Lipoprotein (LDL)|Evaluating change in low-density lipoprotein (LDL) between Baseline and Week 4, comparing subjects treated with aripiprazole for 4 weeks to subjects treated with placebo for 4 weeks.|baseline, week 4|||mg/dL||Standard Deviation|Mean
725274|NCT00351936|Primary|Change From Baseline in Fasting Total Cholesterol|Evaluating change in fasting total cholesterol between Baseline and Week 4, comparing subjects treated with aripiprazole for 4 weeks to subjects treated with placebo for 4 weeks.|baseline, week 4|||mg/dL||Standard Deviation|Mean
725275|NCT00351936|Primary|Change From Baseline in Waist-hip Ratio (WHR)|Evaluating change in waist-hip ratio (WHR) between Baseline and Week 4, comparing subjects treated with aripiprazole for 4 weeks to subjects treated with placebo for 4 weeks.|baseline, week 4|||cm||Standard Deviation|Mean
725276|NCT00351936|Primary|Change From Baseline in Body Mass Index (BMI)|Evaluating change in Body Mass Index (BMI) between Baseline and Week 4, comparing subjects treated with aripiprazole for 4 weeks to subjects treated with placebo for 4 weeks.|baseline, week 4|||kg/m^2||Standard Deviation|Mean
725277|NCT00351936|Primary|Change From Baseline in Weight (Lbs)|Evaluating change in weight (lbs) between Baseline and Week 4, comparing subjects treated with aripiprazole for 4 weeks to subjects treated with placebo for 4 weeks.|baseline, week 4|||lbs||Standard Deviation|Mean
725278|NCT00352027|Secondary|Prognostic Factors for Treatment Failure: Stage|Ann Arbor staging classification was used to stage all patients. Stage was examined (I/II versus III) for the association with event-free survival (EFS), defined as the interval between date on study and of relapse/disease progression, second malignancy, death, or last contact, whichever came first. Given only 11 events, the investigators used univariate Cox model with Score test to compute the p value for the statistical significance. Stage <III showed a better outcome but was not statistically significant.|5.5 (years) median follow-up with minimum 0.3 to maximum 9.4 years follow-up|||events|||Number
725279|NCT00352027|Secondary|Prognostic Factors for Treatment Failure: Histology|Event-free survival (EFS) was calculated for the 80 eligible patients. EFS was defined as the interval between on study to relapse, second malignant tumor, or last contact (all alive) whichever came first. For those who had multiple relapses, the first one was counted. Given only 11 events, we examined individually age, gender, histology and stage for its association with EFS using Cox model. P values from Score test were computed for the statistical significance.|3 years follow-up|||events|||Number
725280|NCT00352027|Secondary|Prognostic Factors for Treatment Failure: Gender|Event-free survival (EFS) was calculated for the 80 eligible patients. EFS was defined as the interval between on study to relapse, second malignant tumor, or last contact (all alive) whichever came first. For those who had multiple relapses, the first one was counted. Given only 11 events, we examined individually age, gender, histology and stage for its association with EFS using Cox model. P values from Score test were computed for the statistical significance.|3 years follow-up|||events|||Number
725281|NCT00352027|Secondary|Toxicities With Grade >1|Comparison of the toxicities of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation (current HOD05 protocol) to those patients on HOD99 (NCT00145600). Grading of toxicities for HOD05 and HOD99 used the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|3 years|Toxicities reported below for the current study (HOD05) include all reported toxicities from a participant's on-study date through 2/17/2016. Toxicities reported below for the HOD99 study include all those reported from a participant's on-study date through their off-study date.||adverse events|||Number
725282|NCT00352027|Secondary|3-year Local Failure-free Survival Probability|Comparison of the 3-year local failure-free survival probability along with the whole local failure-free survival distributions of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation to those patients on HOD99.|3 years|||probability||95% Confidence Interval|Number
725283|NCT00352027|Secondary|3-year Overall Survival (OS) Probability|Comparison of the 3-year OS probability along with the whole OS distributions of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation to those patients on HOD99.|3-years|||probability||95% Confidence Interval|Number
725284|NCT00352027|Secondary|3-year Event-free Survival (EFS) Probability|Comparison of thee-year EFS probability along with the whole EFS distributions of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation to those patients on HOD99.|3 years|||probability||95% Confidence Interval|Number
725343|NCT00352027|Secondary|Patient Quality of Life (QoL), PedsQL v.4.0: Psychosocial Health|"Patient QOL will be measured at multiple time points to assess the patient's functioning.
Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100."|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
725285|NCT00352027|Secondary|Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Communication|"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.
Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50."|6 months after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.||beta coefficient||95% Confidence Interval|Number
725286|NCT00352027|Secondary|Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Perceived Physical Appearance|"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.
Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50."|6 months after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.||beta coefficient||95% Confidence Interval|Number
725287|NCT00352027|Secondary|Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Cognitive Problems|"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.
Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50."|6 months after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.||beta coefficient||95% Confidence Interval|Number
725288|NCT00352027|Secondary|Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Worry|"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.
Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50."|6 months after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.||beta coefficient||95% Confidence Interval|Number
725289|NCT00352027|Secondary|Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Treatment Anxiety|"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.
Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50."|6 months after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.||beta coefficient||95% Confidence Interval|Number
725290|NCT00352027|Secondary|Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Procedural Anxiety|"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.
Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50."|6 months after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.||beta coefficient||95% Confidence Interval|Number
725291|NCT00352027|Secondary|Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Nausea|"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.
Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50."|6 months after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.||beta coefficient||95% Confidence Interval|Number
725364|NCT00352053|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 144||Week 144|ITT Analysis Set, missing = excluded method||Percentage of participants|||Number
725365|NCT00352053|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96||Week 96|ITT Analysis Set, missing = excluded method||Percentage of participants|||Number
725292|NCT00352027|Secondary|Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Pain and Hurt|"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.
Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50."|6 months after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.||beta coefficient||95% Confidence Interval|Number
725293|NCT00352027|Secondary|Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Total Score|"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.
Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50."|6 months after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.||beta coefficient||95% Confidence Interval|Number
725294|NCT00352027|Secondary|Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: School Functioning|"Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.
Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50."|6 months after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.||beta coefficient||95% Confidence Interval|Number
725295|NCT00352027|Secondary|Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Social Functioning|"Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.
Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50."|6 months after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.||beta coefficient||95% Confidence Interval|Number
725296|NCT00352027|Secondary|Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Emotional Functioning|"Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.
Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50."|6 months after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.||beta coefficient||95% Confidence Interval|Number
725297|NCT00352027|Secondary|Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Psychosocial Health|"Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.
Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50."|6 months after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.||beta coefficient||95% Confidence Interval|Number
725298|NCT00352027|Secondary|Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Physical Functioning|"Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.
Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50."|6 months after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.||beta coefficient||95% Confidence Interval|Number
725322|NCT00352027|Secondary|Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Pain and Hurt|Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
725299|NCT00352027|Secondary|Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Total Score|"Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.
Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50."|6 months after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.||beta coefficient||95% Confidence Interval|Number
725300|NCT00352027|Secondary|Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Communication|"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.
Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
725301|NCT00352027|Secondary|Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Perceived Physical Appearance|"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.
Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
725302|NCT00352027|Secondary|Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Cognitive Problems|"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.
Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
725303|NCT00352027|Secondary|Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Worry|"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.
Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
725304|NCT00352027|Secondary|Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Treatment Anxiety|"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.
Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
725305|NCT00352027|Secondary|Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Procedural Anxiety|"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.
Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
725366|NCT00352053|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48||Week 48|ITT Analysis Set. The Tenofovir DF and Placebo groups were analyzed using the missing = failure method. The Placebo/TDF groups were analyzed using the missing = excluded method.||Percentage of participants|||Number
725306|NCT00352027|Secondary|Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Nausea|"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.
Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
725307|NCT00352027|Secondary|Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Pain and Hurt|"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.
Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
725308|NCT00352027|Secondary|Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Total Score|"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.
Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
725309|NCT00352027|Secondary|Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: School Functioning|"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.
Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score."|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
725310|NCT00352027|Secondary|Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Social Functioning|"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.
Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score."|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
725311|NCT00352027|Secondary|Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Emotional Functioning|"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.
Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score."|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
725312|NCT00352027|Secondary|Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Psychosocial Health|"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.
Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score."|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
725342|NCT00352027|Secondary|Patient Quality of Life (QoL), PedsQL v.4.0: Emotional Functioning|"Patient QOL will be measured at multiple time points to assess the patient's functioning.
Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100."|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
725313|NCT00352027|Secondary|Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Physical Functioning|"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.
Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score."|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
725314|NCT00352027|Secondary|Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Total Score|"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.
Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score."|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
725315|NCT00352027|Secondary|Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Communication|Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
725316|NCT00352027|Secondary|Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Perceived Physical Appearance|Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
725317|NCT00352027|Secondary|Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Cognitive Problems|Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
725318|NCT00352027|Secondary|Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Worry|Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
725319|NCT00352027|Secondary|Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Treatment Anxiety|Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
725320|NCT00352027|Secondary|Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Procedural Anxiety|Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
725321|NCT00352027|Secondary|Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Nausea|Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
725323|NCT00352027|Secondary|Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Total Score|Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
725324|NCT00352027|Secondary|Parent Proxy Quality of Life (QoL), PedsQL v.4.0: School Functioning|Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
725325|NCT00352027|Secondary|Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Social Functioning|Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
725326|NCT00352027|Secondary|Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Emotional Functioning|Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
725327|NCT00352027|Secondary|Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Psychosocial Health|Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
725328|NCT00352027|Secondary|Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Physical Functioning|Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
725329|NCT00352027|Secondary|Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Total Score|Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
725330|NCT00352027|Secondary|Patient Quality of Life (QoL), Symptom Distress Scale|"The patient's degree of discomfort from specific treatment-related symptoms across multiple time points.
Instrument interpretation: SDS, higher scores indicate higher overall symptom distress with a range of 10-50."|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
725331|NCT00352027|Secondary|Patient Quality of Life (QoL), PedsQL v.3.0: Communication|"Patient QOL will be measured at multiple time points to assess the patient's functioning.
Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
725332|NCT00352027|Secondary|Patient Quality of Life (QoL), PedsQL v.3.0: Perceived Physical Appearance|"Patient QOL will be measured at multiple time points to assess the patient's functioning.
Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
725333|NCT00352027|Secondary|Patient Quality of Life (QoL), PedsQL v.3.0: Cognitive Problems|"Patient QOL will be measured at multiple time points to assess the patient's functioning.
Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
725334|NCT00352027|Secondary|Patient Quality of Life (QoL), PedsQL v.3.0: Worry|"Patient QOL will be measured at multiple time points to assess the patient's functioning.
Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
725335|NCT00352027|Secondary|Patient Quality of Life (QoL), PedsQL v.3.0: Treatment Anxiety|"Patient QOL will be measured at multiple time points to assess the patient's functioning.
Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
725336|NCT00352027|Secondary|Patient Quality of Life (QoL), PedsQL v.3.0: Procedural Anxiety|"Patient QOL will be measured at multiple time points to assess the patient's functioning.
Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
725337|NCT00352027|Secondary|Patient Quality of Life (QoL), PedsQL v.3.0: Nausea|"Patient QOL will be measured at multiple time points to assess the patient's functioning.
Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
725338|NCT00352027|Secondary|Patient Quality of Life (QoL), PedsQL v.3.0: Pain and Hurt|"Patient QOL will be measured at multiple time points to assess the patient's functioning.
Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
725339|NCT00352027|Secondary|Patient Quality of Life (QoL), PedsQL v.3.0: Total Score|"Patient QOL will be measured at multiple time points to assess the patient's functioning.
Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
725340|NCT00352027|Secondary|Patient Quality of Life (QoL), PedsQL v.4.0: School Functioning|"Patient QOL will be measured at multiple time points to assess the patient's functioning.
Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100."|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
725341|NCT00352027|Secondary|Patient Quality of Life (QoL), PedsQL v.4.0:Social Functioning|"Patient QOL will be measured at multiple time points to assess the patient's functioning.
Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100."|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
725367|NCT00352053|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 24||Week 24|ITT Analysis Set. The Tenofovir DF and Placebo groups were analyzed using the missing = failure method in which participants with missing data were considered to have failed to achieve the endpoint. The Placebo/TDF groups were analyzed using the missing = excluded method.||Percentage of participants|||Number
725344|NCT00352027|Secondary|Patient Quality of Life (QoL), PedsQl v.4.0: Physical Functioning|"Patient QOL will be measured at multiple time points to assess the patient's functioning.
Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100."|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
725345|NCT00352027|Secondary|Patient Quality of Life (QoL), PedsQL v.4.0: Total Score|"Patient QOL will be measured at multiple time points to assess the patient's functioning.
Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100."|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
725346|NCT00352027|Secondary|Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy||1, 2, 5, and 10 years post therapy||||||
725347|NCT00352027|Secondary|Prognostic Factors for Treatment Failure: Age|Age was examined for the association with event-free survival (EFS) which was defined as the interval between date on study and date of relapse/disease progression, second malignant tumor, death, or last contact, whichever came first. Given only 11 events, the investigators used univariate Cox model with Score test to compute the p value for the statistical significance.|5.5 (years) median follow-up with minimum 0.3 to maximum 9.4 years follow-up|||events|||Number
725348|NCT00352027|Secondary|Local and Distant Failure for Children Treated With Tailored-field Radiation|The cumulative incidence of local and distant failure will be estimated. Effect of competing risks will be taken into account. Local failure is defined as in-field, and distant failure is defined as out-of-field.|from first enrollment date up to 3 years follow-up|||probability that the event occurs||95% Confidence Interval|Number
725349|NCT00352027|Secondary|Disease Failure Rate Within Radiation Fields|Defined as disease that recurs in the initially involved nodal region within the field of irradiation. The disease failure rate within the radiation fields will be estimated with a 95% confidence interval using appropriate methods (e.g., estimate cumulative incidence in the presence of competing risks).|3 years|||proportion of participants||95% Confidence Interval|Number
725350|NCT00352027|Primary|3-year Event-Free Survival Probability|The survival probability for the time interval from treatment start to the time of the first failure (disease recurrence, second malignancy or death) within a 3-year time frame.|3 years|||probability||95% Confidence Interval|Number
725351|NCT00352053|Secondary|Percentage of Participants With Virologic Failure Through Week 48|"Virologic failure was defined as either nonresponse or viral rebound.
Nonresponse (failure to achieve response). Response was defined as either
A ≥ 0.5 log10 copies/mL decrease in HIV-1 RNA from baseline at 2 consecutive visits, or
HIV-1 RNA < 400 copies/mL at 2 consecutive visits.
Viral rebound was defined as either
Participants who achieved a ≥ 0.5 log10 copies/mL decrease from baseline in plasma HIV-1 RNA at 2 consecutive visits, who then subsequently achieved plasma HIV-1 RNA values ≥ 1.0 log10 copies/mL above their on-study nadir (lowest value) and/or plasma HIV-1 RNA values ≥ the baseline value at 2 consecutive visits, or
Participants who achieved plasma HIV-1 RNA levels of < 400 copies/mL at 2 consecutive visits, and then subsequently had plasma HIV-1 RNA levels > 1000 copies/mL at 2 consecutive visits.
The virologic failure rate was estimated from Kaplan-Meier product limit method by including all HIV-1 RNA data collected during the double-blind phase."|Up to 48 weeks|ITT Analysis Set. 1 participant without time to respond [6 days of treatment]) was excluded. Nonresponders were counted as failures at time 0. Rebounders were counted as failures on study day of the first of 2 assessments meeting criteria. Otherwise, they were censored at last double-blind HIV measurement.||Kaplan-Meier percentage|||Number
725352|NCT00352053|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 336|No analysis was performed because the last study participant discontinued after Week 294 and the study was closed.|Week 336|ITT Analysis Set, missing = excluded method|||||
725353|NCT00352053|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 288||Week 288|ITT Analysis Set, missing = excluded method||Percentage of participants|||Number
725354|NCT00352053|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 240||Week 240|ITT Analysis Set, missing = excluded method||Percentage of participants|||Number
725355|NCT00352053|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 192||Week 192|ITT Analysis Set, missing = excluded method||Percentage of participants|||Number
725356|NCT00352053|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 144||Week 144|ITT Analysis Set, missing = excluded method||Percentage of participants|||Number
725357|NCT00352053|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96||Week 96|ITT Analysis Set, missing = excluded method||Percentage of participants|||Number
725358|NCT00352053|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48||Week 48|ITT Analysis Set. The Tenofovir DF and Placebo groups were analyzed using the missing = failure method. The Placebo/TDF groups were analyzed using the missing = excluded method.||Percentage of participants|||Number
725359|NCT00352053|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24||Week 24|ITT Analysis Set. The Tenofovir DF and Placebo groups were analyzed using the missing = failure method. The Placebo/TDF groups were analyzed using the missing = excluded method.||Percentage of participants|||Number
725360|NCT00352053|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 336|No analysis was performed because the last study participant discontinued after Week 294 and the study was closed.|Week 336|ITT Analysis Set, missing = excluded method|||||
725361|NCT00352053|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 288||Week 288|ITT Analysis Set, missing = excluded method||Percentage of participants|||Number
725362|NCT00352053|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 240||Week 240|ITT Analysis Set, missing = excluded method||Percentage of participants|||Number
725363|NCT00352053|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 192||Week 192|ITT Analysis Set, missing = excluded method||Percentage of participants|||Number
725368|NCT00352053|Secondary|Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 336|No analysis was performed because the last study participant discontinued after Week 294 and the study was closed.|Baseline to 336 weeks|ITT Analysis Set, missing = excluded method|||||
725369|NCT00352053|Secondary|Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0log 10 Copies/mL From Baseline to Week 288||Baseline to 288 weeks|ITT Analysis Set, missing = excluded method||Percentage of participants|||Number
725370|NCT00352053|Secondary|Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 240||Baseline to 240 weeks|ITT Analysis Set, missing = excluded method||Percentage of participants|||Number
725371|NCT00352053|Secondary|Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 192||Baseline to 192 weeks|ITT Analysis Set, missing = excluded method||Percentage of participants|||Number
725372|NCT00352053|Secondary|Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 144||Baseline to 144 weeks|ITT Analysis Set, missing = excluded method||Percentage of participants|||Number
725373|NCT00352053|Secondary|Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 96||Baseline to 96 weeks|ITT Analysis Set, missing = excluded method||Percentage of participants|||Number
725374|NCT00352053|Secondary|Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 48||Baseline to 48 weeks|ITT Analysis Set. The Tenofovir DF and Placebo groups were analyzed using the LOCF method. The Placebo/TDF groups were analyzed using the missing = excluded method.||Percentage of participants|||Number
725375|NCT00352053|Secondary|Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 24||Baseline to 24 weeks|ITT Analysis Set. The Tenofovir DF and Placebo groups were analyzed using the LOCF method. The Placebo/TDF groups were analyzed using the missing = excluded method.||Percentage of participants|||Number
725376|NCT00352053|Secondary|Change From Baseline to Week 336 in CD4 Percentage|No analysis was performed because the last study participant discontinued after Week 294 and the study was closed.|Baseline to 336 weeks|ITT Analysis Set, missing = excluded method|||||
725377|NCT00352053|Secondary|Change From Baseline to Week 288 in CD4 Percentage|CD4 percentage is the percentage of total lymphocytes that are CD4 cells.|Baseline to 288 weeks|ITT Analysis Set, missing = excluded method||Percentage of CD4 lymphocytes||Inter-Quartile Range|Median
725378|NCT00352053|Secondary|Change From Baseline to Week 240 in CD4 Percentage|CD4 percentage is the percentage of total lymphocytes that are CD4 cells.|Baseline to 240 weeks|ITT Analysis Set, missing = excluded method||Percentage of CD4 lymphocytes||Inter-Quartile Range|Median
725379|NCT00352053|Secondary|Change From Baseline to Week 192 in CD4 Percentage|CD4 percentage is the percentage of total lymphocytes that are CD4 cells.|Baseline to 192 weeks|ITT Analysis Set, missing = excluded method||Percentage of CD4 lymphocytes||Inter-Quartile Range|Median
725380|NCT00352053|Secondary|Change From Baseline to Week 144 in CD4 Percentage|CD4 percentage is the percentage of total lymphocytes that are CD4 cells.|Baseline to 144 weeks|ITT Analysis Set, missing = excluded method||Percentage of CD4 lymphocytes||Inter-Quartile Range|Median
725381|NCT00352053|Secondary|Change From Baseline to Week 96 in CD4 Percentage|CD4 percentage is the percentage of total lymphocytes that are CD4 cells.|Baseline to 96 weeks|ITT Analysis Set, missing = excluded method||Percentage of CD4 lymphocytes||Inter-Quartile Range|Median
725382|NCT00352053|Secondary|Change From Baseline to Week 48 in CD4 Percentage|CD4 percentage is the percentage of total lymphocytes that are CD4 cells.|Baseline to 48 weeks|ITT Analysis Set, missing = excluded method||Percentage of CD4 lymphocytes||Inter-Quartile Range|Median
725383|NCT00352053|Secondary|Change From Baseline to Week 24 in CD4 Percentage|CD4 percentage is the percentage of total lymphocytes that are CD4 cells.|Baseline to 24 weeks|ITT Analysis Set, missing = excluded method||Percentage of CD4 lymphocytes||Inter-Quartile Range|Median
725384|NCT00352053|Secondary|Change From Baseline to Week 336 in CD4 Count|No analysis was performed because the last study participant discontinued after Week 294 and the study was closed.|Baseline to 336 weeks|ITT Analysis Set, missing = excluded method|||||
725385|NCT00352053|Secondary|Change From Baseline to Week 288 in CD4 Count||Baseline to 288 weeks|ITT Analysis Set, missing = excluded method||cells/mm^3||Inter-Quartile Range|Median
725386|NCT00352053|Secondary|Change From Baseline to Week 240 in CD4 Count||Baseline to 240 weeks|ITT Analysis Set, missing = excluded method||cells/mm^3||Inter-Quartile Range|Median
725387|NCT00352053|Secondary|Change From Baseline to Week 192 in CD4 Count||Baseline to 192 weeks|ITT Analysis Set, missing = excluded method||cells/mm^3||Inter-Quartile Range|Median
725388|NCT00352053|Secondary|Change From Baseline to Week 144 in CD4 Count||Baseline to 144 weeks|ITT Analysis Set, missing = excluded method||cells/mm^3||Inter-Quartile Range|Median
725389|NCT00352053|Secondary|Change From Baseline to Week 96 in CD4 Count||Baseline to 96 weeks|ITT Analysis Set, missing = excluded method||cells/mm3||Inter-Quartile Range|Median
725390|NCT00352053|Secondary|Change From Baseline to Week 48 in CD4 Count||Baseline to 48 weeks|ITT Analysis Set, missing = excluded method||cells/mm3||Inter-Quartile Range|Median
725391|NCT00352053|Secondary|Change From Baseline to Week 24 in Cluster Determinant 4 (CD4) Count||Baseline to 24 weeks|ITT Analysis Set, missing = excluded method||cells/mm3||Inter-Quartile Range|Median
725392|NCT00352053|Secondary|Change From Baseline to Week 336 in HIV-1 RNA|No analysis was performed because the last study participant discontinued after Week 294 and the study was closed.|Baseline to 336 weeks|ITT Analysis Set, missing = excluded method|||||
725393|NCT00352053|Secondary|Change From Baseline to Week 288 in HIV-1 RNA||Baseline to 288 weeks|ITT Analysis Set, missing = excluded method||log10 copies/mL||Inter-Quartile Range|Median
725394|NCT00352053|Secondary|Change From Baseline to Week 240 in HIV-1 RNA||Baseline to 240 weeks|ITT Analysis Set, missing = excluded method||log10 copies/mL||Inter-Quartile Range|Median
725395|NCT00352053|Secondary|Change From Baseline to Week 192 in HIV-1 RNA||Baseline to 192 weeks|ITT Analysis Set, missing = excluded method||log10 copies/mL||Inter-Quartile Range|Median
725396|NCT00352053|Secondary|Change From Baseline to Week 144 in HIV-1 RNA||Baseline to 144 weeks|ITT Analysis Set, missing = excluded method||log10 copies/mL||Inter-Quartile Range|Median
725397|NCT00352053|Secondary|Change From Baseline to Week 96 in HIV-1 RNA||Baseline to 96 weeks|ITT Analysis Set, missing = excluded method||log10 copies/mL||Inter-Quartile Range|Median
725398|NCT00352053|Secondary|Change From Baseline to Week 48 in HIV-1 RNA||Baseline to 48 weeks|ITT Analysis Set. The Tenofovir DF and Placebo groups were analyzed using the LOCF method. The Placebo/TDF groups were analyzed using the missing = excluded method.||log10 copies/mL||Inter-Quartile Range|Median
725399|NCT00352053|Secondary|Change From Baseline to Week 24 in HIV-1 RNA||Baseline to 24 weeks|ITT Analysis Set. The Tenofovir DF and Placebo groups were analyzed using the last observation carried forward (LOCF) method (includes the participant’s last available postbaseline value for missing data). The Placebo/TDF groups were analyzed using the missing = excluded method (participants with missing data were excluded from the analysis).||log10 copies/mL||Inter-Quartile Range|Median
725400|NCT00352053|Secondary|Time-weighted Average Change From Baseline Through Week 48 (DAVG48) in Plasma HIV-1 RNA|"DAVG48 was defined as the time-weighted average between the first postbaseline value through the last value up to Week 48 minus the baseline value. DAVG48 was calculated using the trapezoidal rule with all available postbaseline data minus the baseline value.
Data for participants who discontinued the double-blind phase of the study early were included up until the point of discontinuation from the study (ie, missing data were not imputed)."|Baseline to 48 weeks|ITT Analysis Set||log10 copies/mL||Inter-Quartile Range|Median
725401|NCT00352053|Primary|Time-weighted Average Change From Baseline Through Week 24 (DAVG24) in Plasma HIV-1 RNA|"DAVG24 was defined as the time-weighted average between the first postbaseline value through the last value up to Week 24 minus the baseline value. DAVG24 was calculated using the trapezoidal rule with all available postbaseline data minus the baseline value.
Data for participants who discontinued the randomized (double-blind) phase of the study early were included up until the point of study discontinuation (missing data not imputed)."|Baseline to 24 Weeks|Intent-to-treat (ITT) Analysis Set: participants who were randomized and received at least 1 dose of study drug, with baseline HIV-1 RNA ≥ 1000 copies/mL and who had no major eligibility criteria violations.||log10 copies/mL||Inter-Quartile Range|Median
725402|NCT00352105|Primary|Number of Participants With No Distant Metastatic Disease at 1 Year|1-year distant metastatic disease control in patients with locally advanced squamous cell head and neck cancer. Distant disease means that cancer came back in sites outside of the head and neck.|1 year|5 early deaths were not evaluable||participants|||Number
725403|NCT00352105|Secondary|Number of Participants Who Completed 2 Years of Therapy||at 2 years after start of treatment|||participants|||Number
725404|NCT00352105|Secondary|Number of Patients With a Complete Response Defined as Complete Disappearance of All Clinically Detectable Tumor.|Complete response rate per RECIST Criteria (CTC V3)|3 years|5 early deaths were not evaluable||participants|||Number
725405|NCT00352105|Secondary|Number of Patients With Greater Than or Equal to Mild (Grade 1) Toxicity|Any toxicity greater than or equal to Grade 1= mild|at 1 year after start of treatment|||participants|||Number
725406|NCT00352105|Secondary|Number of Participants With No Local Disease at 1 Year|Number of Participants with No Local Disease at 1 Year. Local disease means that the cancer came back in the same site.|at 1 year after start of treatment|5 early deaths not evaluable||participants|||Number
725407|NCT00352105|Primary|Number of Patients Treated With ZD1839 With Chemotherapy and Hyperfractionated Radiation That Had a 1-year Survival|To explore the activity of ZD1839 with chemotherapy and hyperfractionated radiation using 1-year survival|at 1 year after start of treatment|||participants|||Number
725408|NCT00352118|Secondary|Quality of Life (QOL) by Functional Assessment of Cancer Therapy-H&N QOL Questionnaire|All patients were non-evaluable and study was terminated early. There is no measure of outcome.|baseline, before chemoradiotherapy, 1 month after the last radiation treatment, every 3 months for 1 year, and then every 6 months for 1 year|All patients were non-evaluable - did not receive radiation dose per protocol.|||||
725409|NCT00352118|Secondary|Swallowing Ability - Quality of Life Scores|All patients were non-evaluable and study was terminated early. There is no measure of outcome. Utilizing Swallowing Portion of ASHA Functional Communication Measure for Swallowing (FCM) and Dysphagia Outcome and Severity Scale (DOSS).|Baseline, before chemoradiation, 30 days after last radiation treatment, every 3 months for the first year, then every 6 months for year 2.|All patients were non-evaluable - did not receive radiation dose per protocol.|||||
725410|NCT00352118|Secondary|Time to Treatment Failure|All patients were non-evaluable and study was terminated early. There is no measure of outcome. Measure using RECIST criteria.|Number of Days from Complete or Partial Response to First Date of Recurrence or Progression|All patients were non-evaluable - did not receive radiation dose per protocol.|||||
725411|NCT00352118|Secondary|Number of Days With Disease Free Survival|All patients were non-evaluable and study was terminated early. There is no measure of outcome. RECIST criteria measurement.|From Date of Registration to Date of First Treatment Failure or Death|All patients were non-evaluable - did not receive radiation dose per protocol.|||||
725412|NCT00352118|Secondary|Number of Days - Overall Survival|All patients were non-evaluable and study was terminated early. There is no measure of outcome. Utilizing RECIST criteria.|Between date of registration to date of death.|All patients were non-evaluable - did not receive radiation dose per protocol.|||||
725413|NCT00352118|Secondary|Number of Days With Progression-free Survival|All patients were non-evaluable and study was terminated early. There is no measure of outcome. Utilizing RECIST criteria.|Between date of registration to date of first treatment failure or death.|All patients were non-evaluable - did not receive radiation dose per protocol.|||||
725414|NCT00352118|Primary|Number of Patients With Feeding Tube Dependency|All patients were non-evaluable and study was terminated early. There is no measure of outcome.|at 12 months|All patients were non-evaluable - did not receive radiation dose per protocol.|||||
725415|NCT00352365|Primary|Complete Response|Morphologic complete remission (CR): ANC >=1,000/mcl, platelet count >=100,000/mcl, <5% bone marrow blasts, no Auer rods, no evidence of extramedullary disease. Morphologic complete remission with incomplete blood count recovery (CRi): Same as CR but ANC may be <1,000/mcl and/or platelet count <100,000/mcl.|Up to 5 years|Eligible patients who began protocol therapy||percentage of participants||95% Confidence Interval|Number
725442|NCT00352781|Secondary|Smoking Cessation|7-day point prevalence of abstinence|12 months after end of treatment|Number of participants who completed the 12m follow-up||percentage of participants abstinent|||Number
725443|NCT00352781|Primary|Smoking Cessation|7-day point prevalence of abstinence|6 months after end of treatment|Number of participants that completed the 6m follow-up (i.e. per protocol)||percentage of participants abstinent|||Number
725416|NCT00352365|Secondary|Total Response|Morphologic complete remission (CR): ANC >=1,000/mcl, platelet count >=100,000/mcl, <5% bone marrow blasts, no Auer rods, no evidence of extramedullary disease. Morphologic complete remission with incomplete blood count recovery (CRi): Same as CR but ANC may be <1,000/mcl and/or platelet count <100,000/mcl. Partial remission (PR): ANC >1,000/mcl, platelet count >100,000/mcl, and at least 50% decrease in the percentage of marrow aspirate blasts to 5-25%, or marrow blasts <5% with persistent Auer rods.|Up to 5 years|Eligible patients who began protocol therapy||percentage of participants||95% Confidence Interval|Number
725417|NCT00352365|Secondary|Cytogenetic Abnormalities|Number of baseline cytogenetic abnormalities by responders (CR, CRi, and PR) and nonresponders.|Up to 5 years|||Number of abnormalities||Full Range|Median
725418|NCT00352365|Secondary|Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Up to 5 years|Eligible patients who received any treatment and were assessed for toxicity were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.||Participants|||Number
725419|NCT00352417|Secondary|Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP)||Baseline and 12 weeks|Evaluable population with both baseline and visit 8 results||mg/L||95% Confidence Interval|Least Squares Mean
725420|NCT00352417|Secondary|Change From Baseline in Urine Leukotriene E4 Adjusted for Creatinine||Baseline and 12 Weeks|Evaluable Population||Percent Change||95% Confidence Interval|Geometric Mean
725421|NCT00352417|Secondary|Change From Baseline in Whole Blood Leukotriene B4 Production||Baseline and 12 weeks|Evaluable Population||pg/ml||95% Confidence Interval|Least Squares Mean
725422|NCT00352417|Secondary|Percent Cross-sectional Area of Anti-5-Lipoxygenase Staining in Plaque Tissue|Effect of VIA-2291 100-mg relative to placebo after 12 weeks of daily dosing on the percent cross-sectional area of anti-5-Lipoxygenase staining in plaque tissue|12 weeks|Evaluable Population with histological sections available||Percent Area||95% Confidence Interval|Mean
725423|NCT00352417|Primary|Percent Cross-sectional Area of Macrophages in Plaque Tissue|Effect of VIA-2291 100-mg relative to placebo after 12 weeks of daily dosing on the percent cross-sectional area of macrophages in plaque tissue using an anti-CD68 antibody|12 weeks|Evaluable Population with histological sections available||Percent Area||95% Confidence Interval|Mean
725424|NCT00352534|Secondary|Incidence of Renal Failure|Number of renal failures defined as requiring dialysis or renal transplant as determined by low GFR during follow-up|During follow-up|Very low risk patients that have metachronous relapse.||Incidents|||Number
725425|NCT00352534|Secondary|Incidence of Contralateral Kidney Lesions|Number of contralateral kidney lesions during follow-up.|During follow-up|Very low risk patients treated by nephrectomy and observation only.||Lesions|||Number
725426|NCT00352534|Primary|Overall Survival (OS) Probability|Probability of being alive after 4 years in the study.|4 years|Eligible very low risk or standard risk patients||Probability||95% Confidence Interval|Number
725427|NCT00352534|Primary|Event Free Survival Probability|Probability of no relapse, secondary malignancy, or death after 4 year in the study.|4 years|Eligible very low risk or standard risk patients||Probability||95% Confidence Interval|Number
725428|NCT00352612|Primary|Clinical Improvement at the 48-72 Hour Clinical Follow-up|Clinical improvement was defined as improvement in at least one of the following four measures without regression in any: (1) erythema (2) pain (3) induration (4) patient or families self report of improvement.|48-72 hour clinical follow-up|||participants|||Number
725429|NCT00352664|Primary|Sedation Mean Scores at 1-Week|Anderson Symptom Assessment Scale (ASAS) was used to measure sedation mean scores (SD) on a 0-10 scale with 0 representing “not drowsy” and 10 representing “worst possible drowsiness.”|Baseline and Day 7|Analysis was intention to treat (ITT), and population analyzed was that treated. Study closed early due to low patient accrual and insufficient supply of drug. No patients were randomized to Placebo Arm.||Scores on a Scale||Standard Deviation|Mean
725430|NCT00352690|Secondary|Incidence and Severity of Radiation-induced Pneumonitis||30 days following completion of treatment (approximately 114 days)|Using CTCAE Version 3.0.||participants|||Number
725431|NCT00352690|Primary|Overall Survival (OS)|OS = time from patient registration to death of all causes|Completion of follow-up (follow-up ranged from 3 months to 6 years)|Participants with unknown expiration dates were censored at the date of last clinical contact.||months||95% Confidence Interval|Median
725432|NCT00352690|Secondary|Incidence and Severity of Radiation-induced Esophagitis||30 days following completion of treatment (approximately 114 days)|Using CTCAE Version 3.0||participants|||Number
725433|NCT00352690|Secondary|Response Rates|Overall best response using RECIST 1.0|4 years|||participants|||Number
725434|NCT00352690|Secondary|Failure-free Survival (FFS)|The time between patient registration and a failure event (progression, relapse, or death of all cause, whichever is first)|Completion of follow-up (follow-up ranged from 3 months to 6 years)|Participants with unknown event dates were censored at the date of last clinical contact.||months||95% Confidence Interval|Median
725435|NCT00352690|Secondary|Failure-free Survival (FFS) Rate|"The time between patient registration and a failure event (progression, relapse, or death of all cause, whichever is first)
Estimated using Kaplan Meier"|6 months|Participants with unknown event dates were censored at the date of last clinical contact.||percentage of participants|||Number
725436|NCT00352690|Primary|Overall Survival (OS) Rate|"OS = time from patient registration to death of all causes
Estimated using Kaplan Meier"|6 months|Participants with unknown expiration dates were censored at the date of last clinical contact.||percentage of participants|||Number
725437|NCT00352755|Secondary|Overall Survival||Median follow-up was 32 months|||months||Full Range|Median
725438|NCT00352755|Secondary|Progression-free Survival||Median follow-up was 32 months|||months||Full Range|Median
725439|NCT00352755|Secondary|Number of Participants Who Experience Surgical Complications Associated With This Regimen||Median follow-up was 32 months|||participants|||Number
725440|NCT00352755|Secondary|Progression Rate|-Progressive disease - at least a 20% increase in the sum of the longest diameter of the target lesions taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.|Median follow-up was 32 months|||percentage of participants|||Number
725441|NCT00352755|Primary|Safety and Tolerability of the Planned Treatment Regimen as Measured by Number of Participants With Grade 3 or Higher Adverse Events||30 days after end of treatment|||participants|||Number
725444|NCT00352846|Primary|Percentage Change in Bone Mineral Density (BMD) T-Score From Baseline to 12 Months|The 12-month change from baseline in BMD at the total lumbar spine. BMD evaluation was performed at baseline and at 12 months after initiation of therapy at the lumbar spine. BMD was measured by dual-energy, x-ray absorptiometry scanners. T-Score is the number of standard deviations above or below the mean. A T-score >= -1 indicates a normal BMD, while T-scores between -1 and -2.5 indicate osteopenia and T-scores <= -2.5 indicate osteoporosis.|From baseline to 12 Months|BMD data available on 53 evaluable participants upon treatment completion.||Percentage Change of BMD||Standard Deviation|Mean
725445|NCT00352885|Secondary|Genetic Polymorphisms||Measured before and after IL-2 treatment||||||
725446|NCT00352885|Secondary|Cognitive Functioning, as Assessed by Computerized Neuropsychological Testing||Measured on Day 2 of each IL-2 cycle||||||
725447|NCT00352885|Secondary|Serotonin Metabolism||Measured over 5 months of IL-2 treatment||||||
725448|NCT00352885|Secondary|Serotonin Metabolism||Measured over 5 months of IL-2 treatment||||||
725449|NCT00352885|Secondary|Immune System Functioning||Measured over 5 months of IL-2 treatment||||||
725450|NCT00352885|Secondary|Neuroendocrine System Functioning and Stress Hormone Levels||Measured over 5 months of IL-2 treatment||||||
725451|NCT00352885|Primary|Number of IL-2 Treatments Tolerated||Measured over 5 months of treatment|||one IL-2 injection of 720,000 units/kg||Standard Deviation|Mean
725452|NCT00352911|Primary|Mean Log Change in Viral Load From Baseline (Day 1) to Day 56|Mean log change in HIV RNA viral load (significant reduction is considered >0.5 log 10) from baseline (Day 1) to Day 56 following 150mg twice daily for 14 days, dose escalation to 300mg twice daily for 14 days and then 28 days off treatment.|Baseline (Day 1) to Day 56|||copies/mL on log scale||Standard Deviation|Log Mean
725453|NCT00353119|Secondary|Percentage Change in Palmoplantar Pustulosis Area and Severity Index (PPPASI) After Crossover|"Evaluate efficacy using palmoplantar pustulosis area and severity index (PPPASI) in patient with palmoplantar pustulosis treated with etanercept for 6 months
PPPASI = (E + I + D)Area X 0.2 (R palm) + (E + I + D) Area X 0.2 (L palm) + (E + I + D) Area X 0.3 (R sole) + (E + I + D) Area X 0.3 (L sole).
Erythema, pustules and desquamation are evaluated on a scale of 0 to 4 while area is evaluated on a scale of 0 to 6. The PPPASI score can vary from 0 (absence of disease) to 72 (most severe palmoplantar psoriasis possible)."|12 weeks|The intent to treat (ITT) population is the same as the per protocol (PP) population. There was no imputation technique necessary.||Percentage change||Standard Deviation|Mean
725454|NCT00353119|Secondary|Percentage Change in Palmoplantar Pustulosis Area and Severity Index (PPPASI)|"Evaluate efficacy using palmoplantar pustulosis area and severity index (PPPASI) in patient with palmoplantar pustulosis treated with etanercept for 6 months
PPPASI = (E + I + D)Area X 0.2 (R palm) + (E + I + D) Area X 0.2 (L palm) + (E + I + D) Area X 0.3 (R sole) + (E + I + D) Area X 0.3 (L sole).
Erythema, pustules and desquamation are evaluated on a scale of 0 to 4 while area is evaluated on a scale of 0 to 6. The PPPASI score can vary from 0 (absence of disease) to 72 (most severe palmoplantar psoriasis possible)."|24 weeks|The intent to treat (ITT) population is the same as the per protocol (PP) population. There was no imputation technique necessary.||Percentage change||Standard Deviation|Mean
725455|NCT00353119|Secondary|Number of Adverse Events|Study the safety of etanercept in patients with PPP by collecting adverse events from the screening visit until week 28. For a given AE, a subject will be counted once even if he or she has experienced multiple episodes for that particular AE. An adverse event is any untoward medical occurrence including any clinically significant abnormal laboratory values or variation from the baseline condition to the last visit (week 28) in a patient receiving a pharmaceutical product, without regards to the possibility of a causal relationship with this treatment.|28 weeks|Patients that crossed over from placebo to etanercept are included in the Etanercept group. The placebo group only included adverse events from the first 12 weeks prior to the crossover. The intent to treat (ITT) population is the same as the per protocol (PP) population. There was no imputation technique necessary.||Adverse Events|||Number
725456|NCT00353119|Primary|Percentage Change in Palmoplantar Pustulosis Severity Index (PPPASI) Before Crossover|"Comparison of the percentage change in Palmoplantar pustulosis severity index PPPASI) at 12 weeks in patients treated with placebo or etanercept
PPPASI = (E + I + D)Area X 0.2 (R palm) + (E + I + D) Area X 0.2 (L palm) + (E + I + D) Area X 0.3 (R sole) + (E + I + D) Area X 0.3 (L sole).
Erythema, pustules and desquamation are evaluated on a scale of 0 to 4 while area is evaluated on a scale of 0 to 6. The PPPASI score can vary from 0 (absence of disease) to 72 (most severe palmoplantar psoriasis possible)."|12 weeks|The intent to treat (ITT) population is the same as the per protocol (PP) population. There was no imputation technique necessary.||Percentage change||Standard Deviation|Mean
725457|NCT00353262|Secondary|Marked Laboratory Abnormalities|Number of participants with marked laboratory abnormalities (hematology, coagulation, liver function, renal function, protein, electrolytes, miscellaneous).|Up to 28 days after last chemotherapy administration|All 36 participants who received at least one dose of capecitabine.||Participants|||Number
725458|NCT00353262|Secondary|Number Of Participants With Adverse Events (AEs)|An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product. This includes any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Pre-existing conditions which worsened during the study were also to be reported as AEs.|Approximately 3 Years (up to 28 days after the last intake of study medication)|All 36 participants who received at least one dose of capecitabine.||Participants|||Number
725459|NCT00353262|Secondary|Clearance of Total And Free Platinum|CL is a calculation of the rate at which a drug is removed from the body via renal, hepatic and other clearance pathways, expressed as volume (milliliters) per unit of time (hour).|Pre-dose, and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 and 72 hours from the beginning of the two hour oxaliplatin infusion on Days 2 to 5 of Cycle 1, and Days 1 to 4 for Cycle 2 and 3|All patients for whom observations contributing to the relevant assessments were available, who did not experience dose reductions, and for whom dosing was as required by the protocol were included in the corresponding analysis.||mL/Hr||Geometric Coefficient of Variation|Geometric Mean
725508|NCT00353704|Secondary|Morphine (Opioid) Consumption Cumulated|"Patients were equipped with a morphine PCA (patient controlled analgesia) for 24 hours after surgery. So they could administrate morphine intravenously by pressing a button. The sum of morphine was registered as  cumulated opioid consumption (milligram)"|240 minutes|||mg||Standard Deviation|Mean
725460|NCT00353262|Secondary|Volume of Distribution at Steady State (VSS) of Total And Free Platinum|VSS is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.|Pre-dose, and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 and 72 hours|All patients for whom observations contributing to the relevant assessments were available, who did not experience dose reductions, and for whom dosing was as required by the protocol were included in the corresponding analysis.||mL||Geometric Coefficient of Variation|Geometric Mean
725461|NCT00353262|Secondary|T1/2 Beta of Total And Free Platinum|T1/2 beta is the time measured for the plasma concentration to decrease by 1 half to its original concentration of total and free platinum.|Pre-dose, and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 and 72 hours from the beginning of the two hour oxaliplatin infusion on Days 2 to 5 of Cycle 1, and Days 1 to 4 for Cycle 2 and 3|All patients for whom observations contributing to the relevant assessments were available, who did not experience dose reductions, and for whom dosing was as required by the protocol were included in the corresponding analysis.||hour||Geometric Coefficient of Variation|Geometric Mean
725462|NCT00353262|Secondary|Cmax of Total And Free Platinum|Cmax is defined as maximum observed analyte concentration of Total And Free Platinum.|Pre-dose, and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 and 72 hours from the beginning of the two hour oxaliplatin infusion on Days 2 to 5 of Cycle 1, and Days 1 to 4 for Cycle 2 and 3.|All patients for whom observations contributing to the relevant assessments were available, who did not experience dose reductions, and for whom dosing was as required by the protocol were included in the corresponding analysis.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
725463|NCT00353262|Secondary|AUC0-last of Total And Free Platinum|Area under the plasma concentration-time curve from time zero to the time of the last measurable plasma concentration time point of Total And Free Platinum.|pre-dose, and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 and 72 hours from the beginning of the two hour oxaliplatin infusion on Days 2 to 5 of Cycle 1, and Days 1 to 4 for Cycle 2 and 3.|All patients for whom observations contributing to the relevant assessments were available, who did not experience dose reductions, and for whom dosing was as required by the protocol were included in the corresponding analysis.||ng/mL* hr||Geometric Coefficient of Variation|Geometric Mean
725464|NCT00353262|Secondary|AUC0-infinity for Total Platinum|AUC0-infinity represents the area under the concentration-time curve of the analyte (total platinum) in plasma over the time interval from 0 extrapolated to infinity.|Pre-dose, and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 and 72 hours from the beginning of the two hour oxaliplatin infusion on Days 2 to 5 of Cycle 1, and Days 1 to 4 for Cycle 2 and 3|All patients for whom observations contributing to the relevant assessments were available, who did not experience dose reductions, and for whom dosing was as required by the protocol were included in the corresponding analysis.||ng/mL* hr||Geometric Coefficient of Variation|Geometric Mean
725465|NCT00353262|Secondary|Elimination Half-life Period (t1/2 Beta) of Capecitabine and Its Metabolites (5’-DFUR , 5’-DFCR, 5 FU, and FBAL)|t1/2 Beta is the time measured for the plasma concentration to decrease by 1 half to its original concentration of capecitabine and its metabolites (5’-DFUR , 5’-DFCR, 5 FU, and FBAL)|Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post the dose|All patients for whom observations contributing to the relevant assessments were available, who did not experience dose reductions, and for whom dosing was as required by the protocol were included in the corresponding analysis.||hour||Geometric Coefficient of Variation|Geometric Mean
725466|NCT00353262|Secondary|Maximum Plasma Concentration (Cmax) of Capecitabine and Its Metabolites (5’-DFUR, 5’-DFCR, 5 FU, and FBAL)|Cmax is defined as maximum observed analyte concentration of capecitabine and its metabolites (5’-DFUR, 5’-DFCR, 5 FU, and FBAL)|Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post the dose|All patients for whom observations contributing to the relevant assessments were available, who did not experience dose reductions, and for whom dosing was as required by the protocol were included in the corresponding analysis.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
725467|NCT00353262|Secondary|AUC0-last of Capecitabine and Its Metabolites (5’-DFUR, 5’-DFCR, 5 FU, and FBAL)|Area under the plasma concentration-time curve from time zero to the time of the last measurable plasma concentration time point of capecitabine and its metabolites (5’-DFUR, 5’-DFCR, 5 FU, and FBAL).|Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post the dose|All patients for whom observations contributing to the relevant assessments were available, who did not experience dose reductions, and for whom dosing was as required by the protocol were included in the corresponding analysis.||ng/mL*hr||Geometric Coefficient of Variation|Geometric Mean
725468|NCT00353262|Secondary|AUC (0-infinity) of Capecitabine and Its Metabolites (5’-DFCR, 5-FU, and FBAL)|AUC0-infinity represents the area under the concentration-time curve of the analytes (5’-DFCR, 5-FU, and FBAL) in plasma over the time interval from 0 extrapolated to infinity. After oral administration, capecitabine is first metabolized in the liver to 5’-deoxy-5-fluorocytidine (5’-DFCR), which is then converted to 5’-DFUR, and then catalytically activated to 5-FU.|Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post the dose|All patients for whom observations contributing to the relevant assessments were available, who did not experience dose reductions, and for whom dosing was as required by the protocol were included in the corresponding analysis.||ng/mL*hr||Geometric Coefficient of Variation|Geometric Mean
725469|NCT00353262|Primary|AUC0-inf for Free Platinum|AUC0-infinity represents the area under the concentration-time curve of the analyte (free platinum) in plasma over the time interval from 0 extrapolated to infinity. AUC0-inf for free platinum was calculated for each participant from the concentration-data obtained on Days 2 to 5 of Cycle 1, and Days 1 to 4 for Cycle 2 and 3. Free platinum is not bound to plasma proteins and is considered to be the most clinically significant measure of pharmacological and toxicological activity.|Predose , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 and 72 hours from the beginning of the 2 hour oxaliplatin infusion on Days 2 to 5 of Cycle 1, and Days 1 to 4 for Cycle 2 and 3.|All patients for whom observations contributing to the relevant assessments were available, who did not experience dose reductions, and for whom dosing was as required by the protocol were included in the corresponding analysis.||ng/mL * hr||Geometric Coefficient of Variation|Geometric Mean
725509|NCT00353704|Primary|Mean VAS Pain (Visual Analogue Scale)at Rest (0-100 mm)|The visual analogue scale (VAS) was used for registration of the pain intensity at rest. The score ranges from 0-100, where 0 means no pain and 100 means maximal pain. Higher values represent a worse outcome.|120 minutes after surgery|||Units on a scale||Standard Deviation|Mean
725470|NCT00353262|Primary|Area Under The Plasma Concentration-Time Curve From Zero To Infinity (AUC0–Inf) of 5’-Deoxy-5-fluorouridine 5’-(DFUR)|AUC0-infinity represents the area under the concentration-time curve of the analyte (5’-DFUR) in plasma over the time interval from 0 extrapolated to infinity. The analyte 5’-DFUR, the direct precursor of 5-fluorouracil (5-FU), is considered to be the most important metabolite of capecitabine in plasma. The unit of measure was nanograms per millilitre per hour (ng/mL * hr).|Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post the dose.|All patients for whom observations contributing to the relevant assessments were available, who did not experience dose reductions, and for whom dosing was as required by the protocol were included in the corresponding analysis.||ng/mL*hr||Geometric Coefficient of Variation|Geometric Mean
725471|NCT00353275|Secondary|Hypoglycemia||Duration of hospital stay||||||
725472|NCT00353275|Secondary|Organ Failure||Duration of hospital stay||||||
725473|NCT00353275|Primary|Composite Outcome (Favorable Outcome Defined as Discharge Home, Without an Amputation, in Less Than the Median Hospital Stay for Survivors)||Duration of hospital stay||||||
725474|NCT00353275|Primary|Infectious Morbidity||Duration of hospital stay, an average of 2 weeks|The study was stopped because it appeared we would not be able to enroll enough patients into the study by the time funding would conclude. Because only a total of 5 patients were enrolled and underwent study procedures, there was not enough data to be analyzed.|||||
725475|NCT00353301|Secondary|Overall Survival|For all subjects who had not died at the time of statistical analysis, duration of survival will was censored at the date of last contact. Kaplan-Meier methodology was used to estimate the magnitude of the treatment effect as described for progression-free survival.|Survival follow-up information was collected every 4 months following the termination visit until death, loss to follow-up, or study termination up to 275 weeks.|Per protocol analysis was used and 25 participants that were enrolled in the study were included in the analysis.||Weeks||95% Confidence Interval|Median
725476|NCT00353301|Primary|Progression-free Survival|Time to progression was defined as the time from beginning of therapy until disease progression or death. For subjects who had not progressed at the time of statistical analysis, progression-free survival was censored at the date of their last tumor assessment. Kaplan-Meier method was used to estimate median progression-free survival. Progression was defined as radiographic progression according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria (year 2000 version), non-compliance in obtaining scans, unequivocal clinical progression or the initiation of another medication for the treatment of renal cell carcinoma.|Physical exam assessments were performed every 4 weeks during the treatment phase. Survival follow-up information was collected every 4 months following the termination visit until death, loss to follow-up, or study termination up to 275 weeks.|Per protocol analysis was used and 25 participants that were enrolled in the study were included in the analysis.||Weeks||95% Confidence Interval|Median
725477|NCT00353366|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|An SAE is any untoward medical occurrence that : results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|Throughout the study period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one dose of the Rotarix vaccine administration documented.||Participants|||Number
725478|NCT00353366|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|Unsolicited Adverse event (AE) covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During 31 days after each vaccine dose|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one dose of the Rotarix vaccine administration documented.||Subjects|||Number
725479|NCT00353366|Secondary|Number of Subjects Reporting Solicited Symptoms|Solicited symptoms assessed include cough, diarrhea, fever, irritability, loss of appetite and vomiting.|During 15 days after each vaccine dose|The analysis was performed on the Total Vaccinated cohort , which included all vaccinated subjects with at least one dose of the Rotarix vaccine administration documented.||Subjects|||Number
725480|NCT00353366|Primary|Number of Subjects Reporting Grade 2 or 3. Grade 2 : An AE Which Was Sufficiently Discomforting to Interfere With Normal Everyday Activities. Grade 3: an Unsolicited AE That Prevented Normal Everyday Activity.|Grade 2 or 3 assessed include fever, vomiting and diarrhea|During 15 days after each vaccine dose|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects with at least one dose of the Rotarix vaccine administration documented.||Subjects|||Number
725481|NCT00353418|Primary|Incidence of Adverse Events, Dose Reductions and Withdrawals Due to Anemia|Adverse events of anemia included hemolytic anemia, aplasia pure red cell, and pancytopenia.|Up to Week 72|The Safety population included all patients randomized who received at least one dose of the study medication and had at least one postbaseline safety assessment: PEG-IFN alfa 2-a 180 μg + ribavirin 800 mg = 135 patients; PEG-IFN alfa 2-a 180 μg + ribavirin 1000 or 1200 mg = 274 patients.||Percentage of participants|||Number
725482|NCT00353418|Secondary|Early Virological Response (EVR), Partial EVR and Complete EVR by Week 12|EVR: Undetectable HCV RNA <20 IU/mL or ≥2 log10 drop from pretreatment level, by Week 12 (a single last HCV RNA <20 IU/mL or ≥2 log10 drop from pretreatment level in the time window of Days 2 to 99). Partial EVR: Detectable HCV RNA but ≥2 log10 drop from pretreatment, by Week 12 (a single last HCV RNA detectable but ≥2 log10 drop from pretreatment in the time window of Days 2 to 99). Complete EVR: Undetectable HCV RNA <20 IU/mL, by Week 12 (a single last HCV RNA <20 IU/mL in the time window of Days 2 to 99). Patients without an HCV measurement by Week 12 were considered nonresponders.|Week 12|The All Patients Treated population included all patients randomized who had received at least one dose of study medication: PEG-IFN alfa 2-a 180 μg + ribavirin 800 mg = 135 patients; PEG-IFN alfa 2-a 180 μg + ribavirin 1000 or 1200 mg = 275 patients.||Percentage of participants|||Number
725483|NCT00353418|Secondary|Rapid Virological Response (RVR) by Week 4|RVR was defined as an undetectable HCV RNA < 20 IU/mL (a single last HCV RNA < 20 IU/mL falling in the time window of Days 2 to 43). Patients without an HCV measurement by Week 4 were considered nonresponders.|Week 4|The All Patients Treated population included all patients randomized who had received at least one dose of study medication: PEG-IFN alfa 2-a 180 μg + ribavirin 800 mg = 135 patients; PEG-IFN alfa 2-a 180 μg + ribavirin 1000 or 1200 mg = 275 patients.||Percentage of participants|||Number
725484|NCT00353418|Secondary|Relapse of Virological Response|Relapse of virological response was calculated by dividing the number of patients who achieved a virological response at the end of treatment but had detectable HCV RNA at the last assessment posttreatment by the number of patients with a virological response at the end of treatment who had at least one HCV RNA assessment posttreatment.|Weeks 48 and 72|Within the All Patients Treated population, patients with a response at end of treatment: PEG-IFN alfa 2-a 180 μg + ribavirin 800 mg = 37 patients; PEG-IFN alfa 2-a 180 μg + ribavirin 1000 or 1200 mg = 83 patients.||Percentage of participants|||Number
725485|NCT00353418|Secondary|Virological Response at Weeks 4, 12 and 24|Virological response at Weeks 4, 12 and 24 was also defined as a single last undetectable HCV RNA (< 20 IU/mL) falling within the visit windows of Days 16 to 43, 72 to 99, and 156 to 183, respectively. Patients without an HCV measurement at a study week were considered nonresponders at that study week.|Weeks 4, 12 and 24|The All Patients Treated population included all patients randomized who had received at least one dose of study medication: PEG-IFN alfa 2-a 180 μg + ribavirin 800 mg = 135 patients; PEG-IFN alfa 2-a 180 μg + ribavirin 1000 or 1200 mg = 275 patients.||Percentage of participants|||Number
725486|NCT00353418|Secondary|Virological Response at End of Treatment Period|Virological response at the end of the treatment period was defined as a single last HCV RNA measurement <20 IU/mL at the completion of the treatment period (Days 324 to 351). Patients without an HCV measurement at Week 48 were considered nonresponders.|Week 48|The All Patients Treated population included all patients randomized who had received at least one dose of study medication: PEG-IFN alfa 2-a 180 μg + ribavirin 800 mg = 135 patients; PEG-IFN alfa 2-a 180 μg + ribavirin 1000 or 1200 mg = 275 patients.||Percentage of participants|||Number
725487|NCT00353418|Primary|Sustained Virological Response (SVR)|SVR was defined by the percentage of patients with undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) at 24 weeks after completion of the 48-week treatment period (i.e., a single last HCV RNA < 20 IU/mL measured ≥ Day 477 [≥ Week 68]). Patients without an HCV measurement at the end of the 24-week untreated follow-up period were considered nonresponders.|Week 72|The All Patients Treated population included all patients randomized who had received at least one dose of study medication: PEG-IFN alfa 2-a 180 μg + ribavirin 800 mg = 135 patients; PEG-IFN alfa 2-a 180 μg + ribavirin 1000 or 1200 mg = 275 patients.||Percentage of participants|||Number
725488|NCT00353431|Secondary|Frequency of Hypokalaemia|Number of participants with hypokalaemia (potassium < 3.6 mmol/l, safety endpoint, expected to be similar in the two groups)|during observation of 48 hours|||participants|||Number
725489|NCT00353431|Secondary|Frequency of Severe Hypoglycaemia|Number of participants with severe hypoglycaemia (plasma glucose < 2.5 mmol/l) (safety endpoint, expected to be similar in the two groups)|during observation of 48 hours|||participants|||Number
725490|NCT00353431|Secondary|Frequency of Hypoglycemia|absolute number of participants with hypoglycemia (plasma glucose < 3.8 mmol/l) (safety endpoint, expected to be similar in the two groups)|during observation of 48 hours|||participants|||Number
725491|NCT00353431|Secondary|Time to Reach the Target Range|Hours needed to reach 5.5.-7.0 mmol/l (expected to be shorter in the intensive insulin group).|24 h|Intension to treat||hours||Standard Deviation|Mean
725492|NCT00353431|Primary|Time in the Glycaemic Target Range (5.5-7.0 mmol/l) During the Period of Observation of 48 Hours|Hours in which the plasma glucose was between 5.5 and 7.0 mmol/l (expected to be longer in the intensive insulin group)|48 h|Intension to treat||hours||Standard Deviation|Mean
725493|NCT00353496|Secondary|Percentage of Patients Still Alive Based on Available Overall Survival Data|Overall survival defined as the time from randomisation to death due to any cause. Subjects were followed for overall survival beyond study completion/withdrawal via annual telephone contact until the last subject completed the study.|Randomisation to death or last visit, up to 321 weeks|Analysis based on the intent-to-treat (ITT) population which comprised 204 randomised subjects.||percentage of participants|||Number
725494|NCT00353496|Secondary|Percentage of Patients With a Greater Than or Equal to 50% Decrease in Plasma Chromogranin A (CgA) Levels||Week 12 to Week 96 (last visit)|Analysis based on the subgroup of subjects with an elevated plasma CgA values. Subjects with a gastrinoma were excluded from the analysis.||percentage of participants|||Number
725495|NCT00353496|Secondary|Change in the Global Health Status Quality of Life Assessment|Transformed scores from European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire responses (QLQ)-C30. Questionnaire response scores range from 0 to 100. Higher scores indicate best possible Quality of Life.|Week 12 to Week 96 (last visit)|Analysis based on the intent-to-treat (ITT) population which comprised 193 randomised subjects with valid assessment.||score on a scale||Standard Error|Least Squares Mean
725496|NCT00353496|Secondary|Pharmacokinetic Profile of Lanreotide|Pharmacokinetic Profile of Lanreotide assessed by mean serum concentration at specified timepoints|Week 4, 12, 24, 36, 48, 72, 96|Analysis based on the intent-to-treat (ITT) population which comprised 101 randomised subjects who received lanreotide||ng/mL||Standard Deviation|Mean
725497|NCT00353496|Secondary|Percentage of Patients Alive & Without Disease Progression|Percentage of patients still ongoing (or completing at Week 96) without centrally assessed disease progression or death at Weeks 48 and 96.|Week 48 & 96|Analysis based on the intent-to-treat (ITT) population which comprised 204 randomised subjects.||Percentage of participants|||Number
725498|NCT00353496|Primary|Progression-Free Survival (PFS)|Time from randomization to first documentation of disease progression, or death. Disease progression centrally assessed using Response Evaluation Criteria in Solid Tumours (RECIST) v1.0|From randomisation up to the last tumour assessment (scheduled at 96 weeks). Radiological scans were performed every 12 weeks during the first year and every 24 weeks during the second year|Analysis based on the intent-to-treat (ITT) population which comprised 204 randomised subjects.||Weeks||95% Confidence Interval|Median
725499|NCT00353652|Secondary|Body Weight||Measured at 6 months||||||
725500|NCT00353652|Secondary|Electrolytes||Measured at 6 months||||||
725501|NCT00353652|Primary|Inflammatory Cytokines||Measured at 6 months||||||
725502|NCT00353652|Primary|C-reactive Protein||Measured at 6 months||||||
725503|NCT00353652|Primary|Baroreflex Sensitivity||Measured at 6 months||||||
725504|NCT00353652|Primary|Forearm Blood Flow||Measured at 6 months||||||
725505|NCT00353652|Primary|Insulin Sensitivity||Measured at 6 months||||||
725506|NCT00353652|Primary|24-hour Ambulatory Blood Pressure||Measured at 6 months||||||
725507|NCT00353652|Primary|Sympathetic Nerve Activity||Measured at 6 months|||bursts/min||Standard Deviation|Mean
725510|NCT00353795|Primary|Mean Coronary Wall Thickness|Average thickness of the wall of the left anterior descending, right and left main coronary artery measured by magnetic resonance imaging (MRI).|n/a (cross sectional analysis)|||mm||Standard Deviation|Mean
725511|NCT00353873|Secondary|Number of Participants Who Achieved WC Asthma|WC asthma is defined as two or more of symptom score >1 only allowed on <=2 days/week, rescue salbutamol/albuterol use on <=2 days/week and up to a maximum of 4 times per week, >=80% predicted morning PEF daily assessed for 7 consecutive days and all the following criteria: no night-time awakening due to asthma, no exacerbations, no emergency visits, no treatment related adverse events enforcing a change in any asthma therapy. Number of participants/group who achieved the status of at least WC during the last 8 wks of treatment was analyzed using logistic regression, including covariates for sex, age, treatment group, country amalgamation and baseline prebronchodilator FEV1. Each week was classified as ‘WC’, ‘Not Controlled’ or ‘Unevaluable’. A participant was considered to have WC asthma if they achieved 4/4, 5/5, 6/6, 6/7, 7/8 or 8/8 wks that were WC. ‘Unevaluable’ classification included participants with less than 4 wks of data during the assessment period.|Week 5 up to Week 12|ITT Population. Only participants with analyzable data at the indicated time point were assessed.||Participants|||Number
725512|NCT00353873|Secondary|Number of Participants Who Achieved 'Totally Controlled' (TC) Asthma|TC asthma is defined as no daily symptoms, no night-time wakening due to asthma, no exacerbations, no rescue salbutamol/albuterol use, no emergency visits, >=80% predicted morning PEF, and no treatment related adverse events enforcing a change in asthma therapy over 7 consecutive days. Number of participants/group who achieved the status of at least TC during the last 8 weeks (wks) of treatment was analyzed using logistic regression, including covariates for sex, age, treatment group, country amalgamation and baseline pre-bronchodilator Forced Expiratory Volume in one second (FEV1). Asthma control was assessed each week for the last 8 wks of treatment period. Each week was classified as ‘TC’, ‘Well Controlled’ (WC), ‘Not Controlled’ or ‘Unevaluable’. A participant was considered to have TC asthma if they achieved 4/4, 5/5, 6/6, 6/7, 7/8 or 8/8 wks that were TC. ‘Unevaluable’ classification included participants with less than 4 wks of data during the assessment period.|Week 5 up to Week 12|ITT Population. Only participants with analyzable data at the indicated time point were assessed.||Participants|||Number
725513|NCT00353873|Primary|Mean Change From Baseline in Morning PEF Over 12 Weeks in Per Protocol (PP) Population|PEF is the maximum flow generated during expiration, as measured with a peak flow meter and recorded in eDRC, performed with maximal force and started after a full inspiration. The mean morning PEF measurement was constructed by calculating a simple mean for each participant over the interval Weeks 1 to 12. All PEF measurements were converted to the Wright/McKerow peak flow meter scale for the purposes of analyses. The change from Baseline is then calculated by subtracting the Baseline PEF values from the individual on-treatment values. Baseline was calculated as the mean of the values recorded on the seven days preceding randomization. The analysis was done using ANCOVA adjusted for baseline PEF, country amalgamation, age, sex and treatment.|Baseline; Week 1 up to Week 12|PP Population: All participants in the ITT Population who did not have any protocol violations which could impact treatment effect. Only participants with analyzable data at the indicated time point were assessed.||L/min||Standard Error|Least Squares Mean
725514|NCT00353873|Primary|Mean Change From Baseline in Morning Peak Expiratory Flow (PEF) Over 12 Weeks in Intent-to-treat (ITT) Population|PEF is the maximum flow generated during expiration, as measured with a peak flow meter and recorded in electronic diary record card (eDRC), performed with maximal force and started after a full inspiration. The mean morning PEF measurement was constructed by calculating a simple mean for each participant over the interval Weeks 1 to 12. All PEF measurements were converted to the Wright/McKerow peak flow meter scale for the purposes of analyses. The change from Baseline is then calculated by subtracting the Baseline PEF values from the individual on-treatment values. Baseline was calculated as the mean of the values recorded on the seven days preceding randomization. The analysis was done using analysis of covariance (ANCOVA) adjusted for baseline PEF, country amalgamation, age, sex and treatment.|Baseline; Week 1 up to Week 12|ITT Population: All participants randomized to treatment who received at least one dose of randomized study medication. Only participants with analyzable data at the indicated time point were assessed.||Liters/Minute (L/min)||Standard Error|Least Squares Mean
725515|NCT00347360|Secondary|Diastolic Responders, Defined as ≥ 10 mmHg Sitting (s)DBP Reduction From Baseline or a sDBP of <90 / 80 Millimeters (mm) of Mercury (Hg) for Non Diabetic / Diabetic Subjects Respectively (Based on Cuff Trough Measures)||Week 6|ITTE with LOCF. Intent to Treat Efficacy population is defined as all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment.||participants|||Number
725516|NCT00347360|Secondary|Change From Baseline to Week 6 in Mean Trough Sitting SBP and Sitting DBP by Cuff Assessment|Analysis of Change from Baseline to Week 6 in Mean sSBP and sDBP by Cuff Assessments at Drug Trough (20-24 hr) at End of Treatment Titration|Baseline, Week 6|ITTE with LOCF. Intent to Treat Efficacy population is defined as all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment.||mmHg||Standard Deviation|Mean
725517|NCT00347360|Secondary|Change From Baseline to Week 6 in Mean SBP and DBP Measured at Night by 24hr ABPM|Mean changes from Baseline to Week 6 in DBP and SBP measured by 24hr ABPM at the end of up-titration recorded in the night. The night-time assessment period started at the time of the first reading at or after 6 pm and ended immediately before 6 am on the following day.|Night BP, Baseline, Week 6|: ABPM Population with LOCF: This comprised all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment with valid Baseline and on-therapy ABPM measures. All efficacy data derived from ABPM assessments were summarized by this population||mmHg||Standard Deviation|Mean
725518|NCT00347360|Secondary|Change From Baseline to Week 6 in Mean SBP and DBP Measured in Afternoon by 24hr ABPM|Mean changes from Baseline to Week 6 in SBP and DBP measured by 24hr ABPM at the end of up-titration recorded in the afternoon. The afternoon assessment period started at or after 12 noon and ended immediately before 6 pm.|Afternoon BP, Baseline, Week 6|ABPM Population with LOCF: This comprised all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment with valid Baseline and on-therapy ABPM measures. All efficacy data derived from ABPM assessments were summarized by this population||mmHg||Standard Deviation|Mean
725532|NCT00347776|Secondary|Surgical Failure|The surgery was considered a failure if one or more eye lashes were touching the globe of the eye of the subject.|6 weeks|||Participants|||Count of Participants
725519|NCT00347360|Secondary|Change From Baseline to Week 6 in Mean SBP and DBP Measured in Morning by 24 Hour ABPM|Mean changes from Baseline to Week 6 in DBP and SBP measured by 24hr ABPM at the end of up-titration recorded in the morning. The morning assessment period started at or after 6 am and ended immediately before 12 noon.|Morning BP, Baseline, Week 6|ABPM Population with LOCF: This comprised all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment with valid Baseline and on-therapy ABPM measures. All efficacy data derived from ABPM assessments were summarized by this population||mmHg||Standard Deviation|Mean
725520|NCT00347360|Secondary|Overall Description of Safety in Each Treatment Group Using Adverse Events, Laboratory Evaluations, ECG Changes, Vital Sign Changes, and Withdrawal Rates.|Refer to Adverse Event section for safety information.|Weeks 1 through 48||||||
725521|NCT00347360|Secondary|Change From Baseline to Week 6 in Trough to Peak Ratios of DBP by 24 Hour ABPM (Ambulatory Blood Pressure Monitoring)|Trough (20-24 hr) to peak (3-7 hr) ratios of DBP were examined in order to evaluate the extent to which once-daily criteria were met (ie trough:peak > 50%). Trough to peak ratios were calculated from change trough mean/change peak mean x 100.|Baseline, Week 6|ABPM Population with LOCF: This comprised all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment with valid Baseline and on-therapy ABPM measures. All efficacy data derived from ABPM assessments were summarized by this population||trough:peak ratio x 100%|||Number
725522|NCT00347360|Secondary|Dose-response Treatment Estimates: Change From Baseline to Week 6 in 24 Hour Mean DBP by ABPM (Ambulatory Blood Pressure Monitoring)|Evaluation of the dose-response relationship between incremental doses of carvedilol CR and lisinopril and mean 24-hr ABPM DBP.|Baseline, Week 6|ABPM Population with LOCF: This comprised all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment with valid Baseline and on-therapy ABPM measures. All efficacy data derived from ABPM assessments were summarized by this population||mmHg||Standard Error|Mean
725523|NCT00347360|Secondary|Change From Baseline to Week 6 in Trough Systolic Blood Pressure|Trough ABPM was the average across 20-24 hr after dosing for each subject.|Baseline, Week 6|ABPM Population with LOCF: This comprised all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment with valid Baseline and on-therapy ABPM measures. All efficacy data derived from ABPM assessments were summarized by this population||mmHg||Standard Deviation|Mean
725524|NCT00347360|Secondary|Change From Baseline to Week 6 in 24 Hour Mean Systolic Blood Pressure|Ambulatory blood pressure monitoring (ABPM) was completed at Baseline and at the end of treatment/Week 6 or early withdrawal by standard electronic ABPM equipment worn by the subject for 24-hr of ambulatory activity. The 24 hr assessment period started at the time of the first reading and ended exactly 24 hr later on the following day. Data collected included mean systolic blood pressure (SBP).|Baseline, Week 6|ABPM Population with LOCF: This comprised all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment with valid Baseline and on-therapy ABPM measures. All efficacy data derived from ABPM assessments were summarized by this population||mmHg||Standard Deviation|Mean
725525|NCT00347360|Primary|Change From Baseline to Week 6 in Trough Diastolic Blood Pressure|Trough ABPM was the average across 20-24 hr after dosing for each subject.|Baseline, Week 6|ABPM Population with LOCF: This comprised all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment with valid Baseline and on-therapy ABPM measures. All efficacy data derived from ABPM assessments were summarized by this population||mmHg||Standard Deviation|Mean
725526|NCT00347360|Primary|Change From Baseline to Week 6 in 24 Hour (hr) Mean Diastolic Blood Pressure|Ambulatory blood pressure monitoring (ABPM) was completed at Baseline and at the end of treatment/Week 6 or early withdrawal by standard electronic ABPM equipment worn by the subject for 24-hr of ambulatory activity. The 24 hr assessment period started at the time of the first reading and ended exactly 24 hr later on the following day. Data collected included mean diastolic blood pressure (DBP).|Baseline, Week 6.|ABPM Population with Last Observation Carried Forward (LOCF): This comprised all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment with valid Baseline and on-therapy ABPM measures. All efficacy data derived from ABPM assessments were summarized by this population.||mmHg||Standard Deviation|Mean
725527|NCT00347438|Primary|Complete Pathologic Response Rate (cPR)|Complete Pathologic Response rate (cPR) was defined as the absence of invasive breast cancer in the breast (mastectomy or lumpectomy) specimen at the time of definitive surgery.|After the first three cycles of therapy, an average of 9 weeks|This study was terminated early as a result of slow accrual. Thus, outcome measures were reported only for 16 patients who completed the first three cycles of capecitabine chemotherapy.||percentage of participants|||Number
725528|NCT00347438|Primary|Complete Clinical Response Rate (CCR)|Complete Clinical Response (CCR) was defined as complete disappearance of all measurable malignant disease, and no new malignant lesion, disease-related symptoms, or evidence of evaluable disease.|After the first three cycles of therapy, an average of 9 weeks|This study was terminated early as a result of slow accrual. Thus, outcome measures were reported only for 16 patients who completed the first three cycles of capecitabine chemotherapy.||percentage of participants|||Number
725529|NCT00347438|Primary|Partial Clinical Response Rate (PR)|Partial Clinical Response (PR) was defined as reduction by at least 50% of the sum of the products of the longest perpendicular diameters of all measurable lesions.|After the first three cycles of therapy, an average of 9 weeks|This study was terminated early as a result of slow accrual. Thus, outcome measures were reported only for 16 patients who completed the first three cycles of capecitabine chemotherapy.||participants|||Number
725530|NCT00347438|Primary|Overall Clinical Response Rate (OCR)|Overall clinical response rate (OCR) was defined as a proportion of patients with a best response of Complete Clinical Response (CCR) or Partial Clinical Response (PCR). CCR was defined as complete disappearance of all measurable malignant disease, and no new malignant lesion, disease-related symptoms, or evidence of evaluable disease. PCR was defined as reduction by at least 50% of the sum of the products of the longest perpendicular diameters of all measurable lesions.|After the first three cycles of therapy, an average of 9 weeks|This study was terminated early as a result of slow accrual. Thus, outcome measures were reported only for 16 patients who completed the first three cycles of capecitabine chemotherapy.||percentage of participants|||Number
725531|NCT00347776|Secondary|Adverse Events|At 6 weeks participants/family members were asked about any hospitalization,death,ocular complaints, gastrointestinal illness or other specific illness or any clinic visit within six weeks of receiving surgery.|6 weeks|||Participants|||Count of Participants
725533|NCT00347776|Primary|Recurrent Trichiasis Between Two Azithromycin Arms|"Recurrence of trichiasis :Clinical assessment for recurrence was done by looking for one or more eye lashes touching globe or evidence of epilation.
If there was evidence of epilation or if one or more eye lashes were touching the globe, it was considered as recurrence of trichiasis."|Primary outcome assessed at 2 weeks,1.5 months, 6 months and 12 months post-surgery|||Participants|||Count of Participants
725534|NCT00347776|Primary|Recurrent Trichiasis in Tetracycline and Azithromycin Groups|Recurrence of trichiasis : Clinical assessment was done by looking for one or more eye lashes touching globe or evidence of epilation.|Primary outcome assessed at 2 weeks,1.5 months, 6 months and 12 months post-surgery|Recurrence rates (expressed as person-years) in the tetracycline arm was compared with the 2 azithromycin arms combined (483+ 485= 968 participants)||Participants|||Count of Participants
725535|NCT00347919|Secondary|Percentage of Participants With Progressive Disease at Week 12|The percentage of participants with progressive disease (PD) 12 weeks after randomization was measured. Participants were classified as having PD if their response at Week 12 was unknown or missing. Per Response Evaluation Criteria In Solid Tumors (RECIST), PD is defined as a >=20% increase in target lesions. IRC, independent review committee.|Week 12|Cohort 2 MITT Population||percentage of participants|||Number
725536|NCT00347919|Secondary|Time to Response (Complete or Partial Response) in Cohort 1 and Cohort 2|Time to response is defined as the time from randomization to the time of first documented evidence of a complete (CR) or partial response (PR). The time to response will depend on when the response is counted as starting. Per RECIST: CR, all detectable tumor has disappeared; PR, a >=30% decrease in the sum of the target dimensions of the target lesions taking as a reference the baseline sum.|The time from randomization to the time of first documented evidence of complete or partial response (up to 81.14 weeks for Cohort 1 and 44.29 weeks for Cohort 2)|MITT Population||weeks||95% Confidence Interval|Median
725537|NCT00347919|Secondary|Duration of Response in Cohort 1|Duration of response is defined as the length of time from the time from the first observation of response until progression of disease or death. Duration of response depends on two things: (1) when response is counted as starting; (2) when response is counted as ending.There were insufficient data to adequately assess duration of response for Cohort 2. IRC, independent review committee. For participants who do not progress or die, duration of response was censored at the date of last adequate assessment.|Time from first documented evidence of complete or partial response until the first documented sign of disease progression or death due to any cause (up to 106.71 weeks)|MITT Population||weeks||Inter-Quartile Range|Median
725538|NCT00347919|Secondary|Response at Week 12 for Cohort 1 and Cohort 2|The percentage of participants achieving either a complete (CR) or partial (PR) tumor response per Response Evaluation Criteria in Solid Tumors (RECIST) is presented. CR, all detectable tumor has disappeared; PR, a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum; Progressive disease (PD), a >=20% increase in target lesions; Stable Disease, small changes that do not meet previously given criteria. IRC, independent review committee. Participants with an unknown or missing response were treated as non-responders.|Week 12|MITT Population||percentage of participants|||Number
725539|NCT00347919|Secondary|Overall Survival for Cohort 1|Overall survival (OS) is defined as the time from randomization until death due to any cause. Participants who are alive as of the date of last contact are censored. There was insufficient follow-up to adequately assess OS for Cohort 2. Median OS cannot be presented for the lapatinib arm because the upper bound of the 95% confidence interval is undefined due to insufficient follow-up.|Randomization until death due to any cause (up to 106.43 weeks)|MITT Population||weeks||95% Confidence Interval|Median
725540|NCT00347919|Primary|Percentage of Participants With Progressive Disease at Week 12 in Cohort 1|The percentage of participants with progressive disease (PD) 12 weeks after randomization was measured. Per Response Evaluation Criteria In Solid Tumors (RECIST), a response of PD is defined as a >=20% increase in target lesions. Participants were also classified as having PD if their response at Week 12 was unknown or missing. Response was determined by an independent radiologist and by an investigator.|Week 12|Cohort 1: Modified Intent-to-Treat (ITT) Population (all randomized, centrally confirmed, ErbB2 FISH-positive participants).||percentage of participants|||Number
725541|NCT00347932|Secondary|Microbial Eradication of Baseline Bacterial Infection|Absence (grade 0 on the ordinal scale) of all ocular bacterial species that were present at or above the threshold value for that species from the Cagle list at baseline.|Day 8 or 9|Modified intent to treat population, culture confirmed, as randomized.||Participants|||Number
725542|NCT00347932|Secondary|Clinical Resolution of Baseline Bacterial Conjunctivitis|The absence (grade 0 on the ordinal scale) of ocular discharge and bulbar conjunctival injection|Day 8 or 9|Modified intent to treat population, culture confirmed, as randomized||Participants|||Number
725543|NCT00347932|Primary|Microbial Eradication of Baseline Bacterial Infection|Absence (grade 0 on the ordinal scale) of all ocular bacterial species that were present at or above the threshold value for that species from the Cagle list at baseline.|Day 5 +/- 1 day|Modified Intent to treat population, culture confirmed, as randomized.||Participants|||Number
725544|NCT00347932|Primary|Clinical Resolution of Baseline Bacterial Conjunctivitis|The absence (grade 0 on the ordinal scale) of ocular discharge and bulbar conjunctival injection|Day 5 +/- 1 day|Modified intent to treat population, culture confirmed, as randomized||Participants|||Number
725545|NCT00347958|Other Pre-specified|Percentage of Participants With Tetanus and Diptheria Antibody Titers ≥ 0.1 Pre- and Post-Vaccination With Adacel®|Seroprotection: Tetanus or diphtheria titer ≥ 0.1 after Adacel® vaccination. Tetanus titers determined by enzyme-linked immunosorbent assay; diphtheria titers determined by toxin neutralization assay.|Day 28 post-vaccination|Tetanus and diphtheria antibody analyses were in all enrolled and vaccinated participants in the per-protocol population. Diphtheria antibody titers were analyzed separately for participants without and with an intervening Menactra vaccination between the previous study and Study Td518.||Percentage of Participants|||Number
725546|NCT00347958|Other Pre-specified|Geometric Mean Titers (GMTs) of Pertussis Antibodies Pre- and Post-Vaccination.|Pre- and post-vaccination GMTs and their 95% confidence intervals for Pertussis were determined by enzyme-linked immunosorbent assay testing.|Day 28 post-vaccination|Geometric mean titers were assessed in the per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
725995|NCT00358826|Secondary|Change From Baseline in Leukotriene E4 (LTE4)|Urinary LTE4 is expressed in pg per mg Creatinine (pg/mg Cr) to normalize for renal excretion rate|Baseline and 12 weeks|Core Study Evaluable Population||pg/mg Cr||95% Confidence Interval|Least Squares Mean
725547|NCT00347958|Other Pre-specified|Geometric Mean Titers (GMTs) of Tetanus and Diphtheria Antibodies Pre- and Post-Vaccination.|Pre- and post-vaccination GMTs and their 95% confidence intervals for diphtheria were determined by toxin neutralization testing; the other antibody levels were determined by enzyme-linked immunosorbent assay testing.|Day 28 post-vaccination|Geometric mean titers were assessed in the per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
725548|NCT00347958|Primary|Percentage of Participants With at Least 1 Solicited Injection Site and Systemic Reactions Post-Vaccination|Solicited Injection Site Reactions: Pain, Erythema/Redness, Swelling. Solicited Systemic Reactions: Fever (Temperature), Headache, Myalgia, Malaise.|0-14 days post-vaccination|"Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.
The solicited systemic reaction, malaise was not collected in the previous studies."||Percentage of Participants|||Number
725549|NCT00348140|Secondary|Change From Baseline in Short Term Memory Assessment|The 11-item ADAS-Cog assessed a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Most items were evaluated by tests, but some were dependent on clinician ratings on a five point scale. Scores range from 0 to 70 with higher scores indicating greater dysfunction. Questions 1 (word recall) and 7 (word recognition) of ADAS-Cog questionnaire was summed to get a short term memory assessment. The score for Question 1 was calculated as the mean number of words not recalled over the trials for which data was available. If data for all three trials was missing, or if the score for Question 7 was missing then the short term memory score will also be set to missing. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value a t Week 0. Estimated value was calculated by Active treatment minus Placebo. The adjusted means were presented.|Baseline (Week 0) and upto Week 48|ITT population. Number of participants with observed data contributing to the analysis.||Scores on an scale||Standard Error|Least Squares Mean
725550|NCT00348140|Secondary|Change From Baseline in HbA1c up to Week 54|Blood samples were collected for assessments of HbA1c levels at Baseline, Weeks 12, 24, 36, 48, 54. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at Week 0.|Baseline (Week 0) and Weeks 12, 24, 36, 48, 54|Safety population. Only those participants available at the indicated time points were analyzed.||Percentage of HbA1c||Standard Deviation|Mean
725551|NCT00348140|Secondary|Changes From Baseline in ECG Parameters- RR Interval, QT Interval, QTcB, QTcF, PR Interval and QRS Duration|Triplicate 12-lead ECG measures was obtained digitally, approximately one minute apart after the participant had rested in the supine position in a quiet room (no TV, minimal talking) for atleast 10 minutes. The ECG parameters includes PR interval, QRS duration, QT – uncorrected interval, QTc Bazett (QTcB), QTc Fridericia (QTcF) and RR interval. The assessments were performed at Baseline and up to Week 54. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at Week 0. Full population data was presented.|Baseline (Week 0) and Weeks 4, 8, 16, 24, 36, 48, 54|Safety population. Only those participants available at the indicated time points were analyzed.||MSEC||Standard Deviation|Mean
725552|NCT00348140|Secondary|Changes From Baseline in Electrocardiogram (ECG) Parameters- HR|Triplicate 12-lead ECG measures was obtained digitally, approximately one minute apart after the participant had rested in the supine position in a quiet room (no TV, minimal talking) for atleast 10 minutes. The ECG parameters includes HR. The assessments were performed at Baseline and up to Week 54. Change from Baseline was calculated as value at scheduled time point minus Baseline value . Baseline was defined as value at Week 0. Full population data was presented.|Baseline (Week 0) and Weeks 4, 8, 16, 24, 36, 48, 54|Safety population. Only those participants available at the indicated time points were analyzed.||Beats per minute (BPM)||Standard Deviation|Mean
725553|NCT00348140|Secondary|Any Time on Treatment Differences in Frequencies of Clinical Chemistry Data Outside the Reference Range|Clinical chemistry parameters were identified as of PCC (High, Low), if values were out of RR: Alanine amino transferase (ALT,none-120 [250percent upper limit of RR, ULRR ]),Album in (0.75-2),Aldolase(1.1-1.1),Aspartate amino transferase (AST,none-105 (3-64y),137.5(65+y),>250 percent ULRR), Alkaline phosphatase(ALP,none-312.5 (20+y),>250percent ULRR),blood urea nitrogen(BUN)/Creatinine ratio(none-1.25),BUN(none-11),Chloride(80-115),Calcium (0.75-1.25),Carbon dioxide(CO2,15-40) content,Creatinine (22,<50percent lower limit of RR [LLRR ]-155, >125percent ULRR),Creatine phosphokinase(CPK,none-1.25),Gamma glutamyl transferase(GGT,none-2.5),Glucose (3.6-7.8),HbA1C, High density lipoprotein (HDL,0.65-none),Lactate dehydrogenase (LDH,none -2), Low density lipoprotein(LDL,none-1.25),Magnesium (0.5-2),Potassium (3-5.5),Phosphorus inorganic(0.5-1.5), Sodium (130-150), Total protein (0.8-1.5),Total cholesterol(none -1.5),Direct Billirubin.|Upto Week 48|Safety population. Only those participants available at the indicated time points were analyzed.||Participants|||Count of Participants
725554|NCT00348140|Secondary|Any Time on Treatment Differences in Frequencies of Hematology Data Outside the Reference Range|Haematology parameters were identified as of PCC (high [H], low [L]), if the values were out of the reference range (RR). The range for parameters was: platelet (100AV-500AV), red blood cell (RBC , 0.8-1.2), hemoglobin (L: female [F]:10, male [M]:11; H: F:16.5–AV, M:18), hematocrit (0.8-1.2), white blood cell (WBC, 3-15), Total neutrophils (ANC- absolute Neutrophil count) (0.75-1.5), lymphocytes (0.75-1.5), monocyte s (0.75-2), eosinophils (none -2), basophils (none -2), mean corpuscle volume (MCV, 0.8-1.2), mean corpuscular hemoglobin (MCH, 0.8-1.2), mean corpuscular hemoglobin concentration (MCHC , 0.8-1.2), red cell distribution width (RDW, 0.8-1.2), Neutrophil bands (none-1) and segmented neutrophils (0.75-1.3). Full population data was presented.|Up to Week 48|Safety population. Only those participants available at the indicated time points were analyzed.||Participants|||Count of Participants
725555|NCT00348140|Secondary|Change From Baseline in Hematocrit|Hematology parameters were assessed at Baseline and up to Week 48. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at Week 0.|Baseline (Week 0) and Weeks 4, 16, 36, 48|Safety population. Only those participants available at the indicated time points were analyzed.||Ratio||Standard Deviation|Mean
725556|NCT00348140|Secondary|Change From Baseline in Hemoglobin|Hematology parameters were assessed at Baseline, Weeks 4, 16, 36, 48. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at Week 0. Full population data was presented.|Baseline (Week 0) and Weeks 4, 16, 36, 48|Safety population. Only those participants available at the indicated time points were analyzed.||Gram\Liter (G\L)||Standard Deviation|Mean
725557|NCT00348140|Secondary|Change From Baseline in Weight|Body weight was measured at all visits, without shoes and wearing light clothing. The assessment was performed at Baseline, Weeks 4, 8, 12, 16, 24, 36, 48, 54. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at Week 0. Full population data was presented.|Baseline (Week 0) and Weeks 4, 8, 12, 16, 24, 36, 48, 54|Safety population. Only those participants available at the indicated time points were analyzed.||Kilograms (Kg)||Standard Deviation|Mean
725558|NCT00348140|Secondary|Number of Participants With Change From Baseline in Vital Signs of Clinical Concern at Any Time on Treatment- Heart Rate (HR)|HR of participants were recorded in sitting posture as vital sign at each visit. The HR values were identified as of potential clinical concern if the values were out of the reference range (50 to 100 beats per minute) or meet a change from baseline criterion. The change from baseline criterion for HR, was increase from Baseline (high) if increased by more than or equal to (>=) 30 from Baseline; decrease from Baseline (low) if decreased by >= 30 from Baseline. Baseline was defined as value at Week 0. Full population data was presented.|Upto Week 54|Safety population. Only those participants available at the indicated time points were analyzed.||Participants|||Count of Participants
725559|NCT00348140|Secondary|Number of Participants With Change From Baseline in Vital Signs of Clinical Concern at Any Time on Treatment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|SBP and DBP of participants were recorded in sitting posture as vital sign at each visit. The blood pressure (BP) values were identified as of potential clinical concern if the values were out of the reference range (for SBP, 90 to 140 mmHg and DBP, 50 to 90 mmHg) or meet a change from baseline criterion. The change from baseline criterion for SBP, was increase from Baseline (high) if increased by more than or equal to (>=) 40 mm Hg from Baseline; decrease from Baseline (low) if decreased by >= 30 mmHg from Baseline. For DBP, increase from baseline (high) if increased by >=30 mmHg from baseline; decrease from Baseline (low) if decreased by >= 20 mmHg from Baseline. Baseline was defined as value at Week 0.|Upto Week 54|Safety population. Only those participants available at the indicated time points were analyzed.||Participants|||Count of Participants
725560|NCT00348140|Secondary|Number of Participants With Change From Baseline in Vital Signs of Clinical Concern at Any Time on Treatment- Weight|Body weight was measured at all visits, without shoes and wearing light clothing. The assessment was performed a t Baseline and up to Week 54. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at Week 0. Full population data was presented.|Upto Week 54|Safety population. Only those participants available at the indicated time point were analyzed.||Participants|||Count of Participants
725561|NCT00348140|Secondary|Number of Participants With On-treatment Adverse Events (AEs), Serious Adverse Events (SAEs) and Severity of AEs|AE was defined as any untoward medical occurrence in a participant temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE was any untoward medical occurrence that, at any dose results in death, was life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect or was considered as medically significant.|Upto Week 48|Safety population consisted of all participants randomized to treatment who had taken at least one dose of study medication. This population was used for analysis of safety data.||Participants|||Count of Participants
725562|NCT00348140|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 48|Blood samples were collected for assessments of HbA1c levels at Baseline and up to Week 48. Change from Baseline was calculated as value at scheduled time point minus Baseline value . Baseline was defined as value at Week 0. Endpoint treatment differences which were adjusted to take account of missing data are derived. Full population data was presented.|Baseline (Week 0) and Week 48|ITT population. Only those participants available at that particular time point were analyzed.||Percentage||Standard Error|Least Squares Mean
725563|NCT00348140|Secondary|Change in CDR-SB Total Score for Observed Cases at Week 54 Compared to Week 48|The CDR-SB was a validated clinical assessment of global function in participants with AD. Impairment was scored in each of 6 cognitive categories on a scale in which none = 0, questionable = 0.5, mild = 1, moderate = 2, and severe = 3. The 6 individual category ratings, or “box scores”, can be added together to give the CDR-Sum of Boxes which ranges from 0 to 18 (severe impairment). It was of interest to compare the single blind phase data between the treatment groups defined based on the double blind treatment group. This analysis only included participants who received at least one dose of single-blind medication. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at Week 0. Full population data was presented.|Week 48 and Week 54|ITT population. Only those participants available at that particular time point were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
725564|NCT00348140|Secondary|Change in ADAS-Cog Total Score for Observed Cases at Week 54 Compared to Week 48|The 11-item ADAS-Cog assessed a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Most items were evaluated by tests, but some were dependent on clinician ratings on a five point scale. Scores range from 0 to 70 with higher scores indicating greater dysfunction. It was of interest to compare the single blind phase data between the treatment groups defined based on the double blind treatment group. This analysis only included participants who received at least one dose of single-blind medication. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at Week 0. Full population data was presented.|Week 48 and Week 54|ITT population. This analysis will only include participants who received at least one dose of single-blind medication. Only those participants available at that particular time point were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
725572|NCT00348140|Secondary|Change From Baseline in CDR-SB Score at Weeks 12, 24 and 36|The CDR-SB was a validated clinical assessment of global function in patients with AD. Impairment was scored in each of 6 cognitive categories on a scale in which none = 0, questionable = 0.5, mild = 1, moderate = 2, and severe = 3. The 6 individual category ratings, or “box scores”, can be added together to give the CDR-Sum of Boxes which ranges from 0 to 18 (severe impairment). Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value a t Week 0. Estimated value was calculated by Active treatment minus Placebo. The adjusted means were presented. It was calculated at Weeks 12, 24 and 36. Full population data was presented.|Baseline (Week 0) and Week 12, 24, 36|ITT population. Number of participants with observed data contributing to the analysis.||Scores on a scale||Standard Error|Least Squares Mean
725565|NCT00348140|Secondary|Change From Baseline in Alzheimer’s Carer’s Quality of Life Instrument (ACQLI) Score|The ACQLI is an assessment of caregiver quality of life. This instrument consisted of 30 questions exploring various aspects of carer’s quality of life. Each of the questions had two point response, and the 30 questions were summed to provide a total score. Items were assumed to be unidimensional (i.e., represent a single variable) and were scored 0/1 (false/true) before summation into a total score with a 0–30 range. To ease comparisons between scales, ACQLI scores were transformed to range between 0–100 (100: worse). Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value a t Week 0. Estimated value was calculated by Active treatment minus Placebo. The adjusted means were presented. Full population data was presented.|Baseline (Week 0) and Week 12, 36, 48|ITT population. Number of participants with observed data contributing to the analysis.||Scores on a scale||Standard Error|Least Squares Mean
725566|NCT00348140|Secondary|Change From Baseline in EQ-5D Scale Total Score- Utility Score|The EQ-5D Proxy is an assessment of quality of life and utility benefit. The EQ-5D Proxy is composed of two parts: part one is the five dimensional Health State Classification. The Utility score is a caregiver rating of health status on dimensions of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Answers to each question were responded to on a 3-point scale which indicates the level of impairment (level 1= no problem; level 2=some or moderate problem(s) and level 3=unable, or extreme problem with higher scores indicating greater dysfunction. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value a t Week 0. Estimated value was calculated by Active treatment minus Placebo. The adjusted means were presented. Full population data was presented.|Baseline (Week 0) and Week 12, 36, 48|ITT population. Number of participants with observed data contributing to the analysis.||Scores on a scale||Standard Error|Least Squares Mean
725567|NCT00348140|Secondary|Change From Baseline in European Quality of Life -5 Dimensions (EQ-5D) Scale Total Score- Thermometer Score|The EQ-5D Proxy is an assessment of quality of life and utility benefit. The EQ-5D Proxy is composed of two parts: part two is the visual analogue scale ‘Thermometer’. Caregivers are asked to respond as they feel the participant would on dimensions of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 'Thermometer' has endpoints of 100 (best imaginable health state) and 0 (worst imaginable health state). Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value a t Week 0. Estimated value was calculated by Active treatment minus Placebo. The adjusted means were presented. Full population data was presented.|Baseline (Week 0) and Week 12, 36, 48|ITT population. Number of participants with observed data contributing to the analysis.||Scores on a scale||Standard Error|Least Squares Mean
725568|NCT00348140|Secondary|Change From Baseline in Domains of the Resource Utilization in Dementia Scale (RUD)- Q1 and Q2 Caregiver Hours|The RUD instrument was developed as a comprehensive tool to assess the amount of resource use among demented patients. RUD assessd both formal and informal resource use of the patient and the primary caregiver, making it possible to calculate costs from a societal perspective. Q1 corresponds to the number of hours during the last month the caregiver spent assisting the patient with toilet visits, eating, dressing, grooming, walking and bathing and Q2 corresponds to the number of hours during the last month the caregiver spent assisting the patient with shopping, food preparation, housekeeping, laundry, transportation, taking medication and managing financial matters. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at Week 0. Estimated value was calculated by Active treatment minus Placebo. The adjusted means were presented. Full population data was presented.|Baseline (Week 0) and Week 12, 24, 36, 48|ITT population. Number of participants with observed data contributing to the analysis.||Caregiver hours||Standard Error|Least Squares Mean
725569|NCT00348140|Secondary|Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score|NPI is an assessment of frequency and severity of behavioral disturbances in dementia that comprised of 10 dimensions: delusions, hallucinations, dysphoria, apathy, euphoria, disinhibition, aggressiveness and agitation, irritability, anxiety, aberrant motor activity. Participant’s caregiver asked about behavior in participant. If “Yes”, informant then rated both severity on a 3-point scale, 1-mild to 3-severe (total range: 0-36) and frequency using a 4-point scale, 1-occasionally to 4-very frequently. Total score was frequency × severity. Distress was scored on 5-point scale, 0-no distress to 5-very severe or extreme. Total NPI score was calculated by adding all domain scores; NPI total score: 0-144 and NPI distress score: 0-60, higher scores indicated more severe behavioral disturbance. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at Week 0. Adjusted means were presented. Full population data was presented.|Baseline (Week 0) and Week 8, 16, 24, 48|ITT population. Number of participants with observed data contributing to the analysis.||Scores on a scale||Standard Error|Least Squares Mean
725570|NCT00348140|Secondary|Change From Baseline in Disability Assessment for Dementia (DAD) Total Score|The DAD assessed the ability of a participant to execute basic and instrumental activities of daily living (ADL) and leisure activities. The scale consists of 40 questions assessing basic and instrumental ADLs. This scale assessed a participants’ ability to initiate, plan, and perform activities related to hygiene, dressing, continence, eating, meal preparation, telephoning, going on an outing, finance and correspondence, medications, leisure, and housework. Each item was scored as yes: 1, no: 0 and N/A: not applicable. Higher scores indicate less disability with a score of 100 indicating no disability and 0 indicating no functional ability. The percentage score was calculated as (DAD Total score /Total number of applicable items) multiplied by 100. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at Week 0. Full population data was presented.|Baseline (Week 0) and Week 8, 16, 24, 48|ITT population. Number of participants with observed data contributing to the analysis.||Scores on a scale||Standard Error|Least Squares Mean
725571|NCT00348140|Secondary|Change From Screening in Mini Mental State Examination (MMSE) Total Score|The MMSE consists of 11 tests of orientation, memory (recent and immediate), concentration, language and praxis. Scores range from 0 to 30, with lower scores indicating greater cognitive impairment. The scale is completed by the investigator, based on the performance of the participant. Change from screening was calculated as value at scheduled time point minus screening value. Baseline was defined as value a t Week 0. Estimated value was calculated by Active treatment minus Placebo. The adjusted means were presented. Full population data was presented.|Screening (Week -4) and Week 48|ITT population. Only those participants available at that particular time point were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
725573|NCT00348140|Secondary|Change From Baseline in ADAS-Cog Total Score at Weeks 8, 16, 24 and 36|The 11-item ADAS-Cog assessed a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Most items were evaluated by tests, but some were dependent on clinician ratings on a five point scale. Scores range from 0 to 70 with higher scores indicating greater dysfunction. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value a t Week 0. It was calculated at Weeks 8, 16, 24 and 36. Full population data was presented.|Baseline (Week 0) and Week 8, 16, 24, 36|ITT population. Number of participants with observed data contributing to the analysis.||Scores on a scale||Standard Error|Least Squares Mean
725574|NCT00348140|Primary|Change From Baseline in CDR-SB Score at Week 48, as a Function of APOE ε4 Status in Full Population Cohort|The CDR-SB was a validated clinical assessment of global function in patients with AD. Impairment was scored in each of 6 cognitive categories on a scale in which none = 0, questionable = 0.5, mild = 1, moderate = 2, and severe = 3. The 6 individual category ratings, or “box scores”, can be added together to give the CDR-Sum of Boxes which ranges from 0 to 18 (severe impairment). Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value a t Week 0. Estimated value was calculated by Active treatment minus Placebo. The adjusted means were presented. Primary inference will be based on the week 48 treatment differences obtained from the MMRM model. A hierarchical testing procedure was used to control for statistical tests in the two RSG dose groups and the genetic subgroups.|Baseline (Week 0) and Week 48|ITT population. Number of participants with observed data contributing to the analysis have been presented.||Scores on a scale||Standard Error|Least Squares Mean
725575|NCT00348140|Primary|Change From Baseline in CDR-SB Score at Week 48, as a Function of APOE ε4 Status in All Except E4/E4s Cohort|The CDR-SB was a validated clinical assessment of global function in patients with AD. Impairment was scored in each of 6 cognitive categories on a scale in which none = 0, questionable = 0.5, mild = 1, moderate = 2, and severe = 3. The 6 individual category ratings, or “box scores”, can be added together to give the CDR-Sum of Boxes which ranges from 0 to 18 (severe impairment). Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value a t Week 0. Estimated value was calculated by Active treatment minus Placebo. The adjusted means were presented. Primary inference will be based on the week 48 treatment differences obtained from the MMRM model. A hierarchical testing procedure was used to control for statistical tests in the two RSG dose groups and the genetic subgroups.|Baseline (Week 0) and Week 48|ITT population. Number of participants with observed data contributing to the analysis have been presented.||Scores on a scale||Standard Error|Least Squares Mean
725576|NCT00348140|Primary|Change From Baseline in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) Score at Week 48, as a Function of APOE ε4 Status in APOE4 Negatives Cohort|The CDR-SB was a validated clinical assessment of global function in patients with AD. Impairment was scored in each of 6 cognitive categories on a scale in which none = 0, questionable = 0.5, mild = 1, moderate = 2, and severe = 3. The 6 individual category ratings, or “box scores”, can be added together to give the CDR-Sum of Boxes which ranges from 0 to 18 (severe impairment). Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value a t Week 0. Estimated value was calculated by Active treatment minus Placebo. The adjusted means were presented. Primary inference will be based on the week 48 treatment differences obtained from the MMRM model. A hierarchical testing procedure was used to control for statistical tests in the two RSG dose groups and the genetic subgroups.|Baseline (Week 0) and Week 48|ITT population. Number of participants with observed data contributing to the analysis have been presented.||Scores on a scale||Standard Error|Least Squares Mean
725577|NCT00348140|Primary|Change From Baseline in ADAS-Cog Total Score at Week 48, as a Function of APOE ε4 Status in Full Population Cohort|The 11-item ADAS-Cog assessed a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Most items were evaluated by tests, but some were dependent on clinician ratings on a five point scale. Scores range from 0 to 70 with higher scores indicating greater dysfunction. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value a t Week 0. Estimated value was calculated by Active treatment minus Placebo. The adjusted means were presented. A hierarchical testing procedure was used to control for statistical tests in the two RSG dose groups and the genetic subgroups.|Baseline (Week 0) and Week 48|ITT population. Number of participants with observed data contributing to the analysis have been presented.||Scores on a scale||Standard Error|Least Squares Mean
725578|NCT00348140|Primary|Change From Baseline in ADAS-Cog Total Score at Week 48, as a Function of APOE ε4 Status in All Except E4/E4s Cohort|The 11-item ADAS-Cog assessed a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Most items were evaluated by tests, but some were dependent on clinician ratings on a five point scale. Scores range from 0 to 70 with higher scores indicating greater dysfunction. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value a t Week 0. Estimated value was calculated by Active treatment minus Placebo. The adjusted means were presented. A hierarchical testing procedure was used to control for statistical tests in the two RSG dose groups and the genetic subgroups.|Baseline (Week 0) and Week 48|ITT population. Number of participants with observed data contributing to the analysis have been presented.||Scores on a scale||Standard Error|Least Squares Mean
725579|NCT00348140|Primary|Change From Baseline in Alzheimer's Disease Assessment Scale – Cognitive Subscale (ADAS-Cog) Total Score at Week 48, as a Function of APOE ε4 Status in APOE4 Negatives Cohort|The 11-item ADAS-Cog assessed a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Most items were evaluated by tests, but some were dependent on clinician ratings on a five point scale. Scores range from 0 to 70 with higher scores indicating greater dysfunction. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at Week 0. Estimated value was calculated by Active treatment minus Placebo. The adjusted means were presented. A hierarchical testing procedure was used to control for statistical tests in the two RSG dose groups and the genetic subgroups.|Baseline (Week 0) and Week 48|ITT population comprised of all participants randomized to treatment, who had taken at least one dose of study medication and who had at least one post baseline efficacy assessment. Number of participants with observed data contributing to the analysis have been presented.||Scores on a scale||Standard Error|Least Squares Mean
725580|NCT00348283|Secondary|Number of Subjects With Clinical Remission (CDAI < 150) at Both Week 12 and Week 52|Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) less than 150. A lower score correlates with less severe Crohn's disease activity. The CDAI range for this study was 0 to 961.|Weeks 12 and 52|ITT set. NRI method was used to impute the missing values.||Subjects|||Number
725581|NCT00348283|Secondary|Number of Subjects Without Mucosal Ulceration at Both Week 12 and Week 52|The number of subjects receiving blinded study drug in each treatment group who were without mucosal ulceration at both Week 12 and Week 52.|Weeks 12 and 52|Analysis was on ITT subjects who completed the Double Blind period and had Week 52 evaluations while in the Double Blind period. NRI method was used to impute the missing values.||Subjects|||Number
725582|NCT00348283|Secondary|Number of Subjects With Clinical Remission (CDAI < 150) at Week 52|Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) less than 150. A lower score correlates with less severe Crohn's disease activity. The CDAI range for this study was 0 to 961.|Week 52|ITT set. NRI method was used to impute the missing values.||Subjects|||Number
725583|NCT00348283|Secondary|Number of Subjects Without Mucosal Ulceration at Week 52|The number of subjects receiving blinded study drug in each treatment group who were without mucosal ulceration at Week 52.|Week 52|The secondary efficacy analysis included the ITT subjects who had mucosal ulceration at screening. NRI method was used to impute the missing values.||Subjects|||Number
725584|NCT00348283|Secondary|Number of Subjects With Clinical Remission Crohn's Disease Activity Index (CDAI) < 150 at Week 12|Clinical remission is defined as a CDAI less than 150. A lower score correlates with less severe Crohn's disease activity. The CDAI range for this study was 0 to 961.|Week 12|ITT set. NRI method was used to impute the missing values.||Subjects|||Number
725585|NCT00348283|Primary|Number of Subjects Without Mucosal Ulceration at Week 12|Subjects were to have undergone up to 4 endoscopies to evaluate the presence or absence of mucosal ulceration: at Screening, at Week 12 (subjects who moved to open label (OL) drug between Week 8 and Week 12 because of disease flare or non-response were evaluated by endoscopy prior to receiving OL dosing), at the time of switch from blinded study drug to OL adalimumab at any time after Week 12, and at Week 52 or Early Termination. Subjects who remained blinded for the entire 52-week trial or switched to OL adalimumab between Week 8 and Week 12 were to have undergone 3 endoscopies.|Week 12|Analysis was on ITT subjects with mucosal ulceration at Screening. Subjects who did not have endoscopy at Week 12 were considered to have mucosal ulceration at Week 12 (NRI). If subjects had endoscopy at Week 8, the endoscopy results from Week 8 were carried forward to Week 12 for the primary efficacy analysis.||Subjects|||Number
725586|NCT00348348|Secondary|Microbial Eradication|Microbial eradication of baseline bacterial infection. modified intent to treat (mITT), culture confirmed, as treated|Day 8 or Day 9|modified intent to treat (mITT), culture confirmed, as treated||Participants|||Number
725587|NCT00348348|Secondary|Clinical Resolution|Clinical resolution of conjunctival discharge and bulbar conjunctival injection, modified intent to treat (mITT), culture confirmed, as treated|Day 8 or Day 9|modified intent to treat (mITT), culture confirmed, as treated||Participants|||Number
725588|NCT00348348|Primary|Microbial Eradication|eradication of baseline bacterial infection. modified intent to treat (mITT), culture confirmed, as treated|Day 5 (+/- 1 day)|modified intent to treat (mITT), culture confirmed, as treated||Participants|||Number
725589|NCT00348348|Primary|Clinical Resolution|Resolution of conjunctival discharge and bulbar conjunctival injection. (mITT, culture confirmed, as treated)|Day 5(+/- 1 day)|modified intent to treat (mITT), culture confirmed, as treated||Participants|||Number
725590|NCT00348374|Secondary|Change From Baseline in Standard Deviation of 24-hour Glucose Values Measured by Continuous Glucose Monitoring System (CGMS)|Mean change in standard deviation of all blood glucose values within 24-hour period. Change = mean at observation minus mean at Baseline.|Baseline, Week 12, Week 24|FAS; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.||mg/dL||Standard Deviation|Mean
725591|NCT00348374|Secondary|Change From Baseline in 24-hour Mean Glucose Values Measured by Continuous Glucose Monitoring System (CGMS)|Mean of 24-hour Continuous Glucose Monitoring (CGMS) glucose values. Change from Baseline = mean at observation minus mean Baseline value.|Baseline, Week 12, Week 24|FAS; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.||mg/dL||Standard Deviation|Mean
725592|NCT00348374|Secondary|Change in Patient Treatment Satisfaction (as Assessed by Patient Satisfaction With Insulin Treatment [PSIT] Questionnaire) From Week 4 to Week 24|"Patient Satisfaction with insulin treatment Questionnaire (PSIT): 15-item self administered questionnaire that measures global satisfaction and two domains (subscales): convenience/ease of use and social comfort in people with type 1 and type 2 diabetes. 5-point Likert scale ranging from 1 (strongly agree) to 5 (strongly disagree). The scoring of responses to each item is analyzed so that a higher item score indicates more satisfaction.
Change = difference in mean Patient Satisfaction with Insulin Treatment (PSIT) score from Week 4 to Week 24."|Week 4, Week 24|Due to cancellation of the EXUBERA program descriptive statistics for the Patient Satisfaction of Insulin Treatment (PSIT) Questionnaire were not provided.||scores on scale||Standard Deviation|Mean
725593|NCT00348374|Secondary|Change From Baseline in Patient Treatment Satisfaction (as Assessed by Patient Satisfaction With Insulin Treatment [PSIT] Questionnaire)|Patient Satisfaction with insulin treatment Questionnaire (PSIT): 15-item self administered questionnaire that measures global satisfaction and two domains (subscales): convenience/ease of use and social comfort in people with type 1 and type 2 diabetes. 5-point Likert scale ranging from 1 (strongly agree) to 5 (strongly disagree). The scoring of responses to each item is analyzed so that a higher item score indicates more satisfaction. Change = mean Patient Satisfaction of Insulin Treatment (PSIT) score at observation minus mean score at Baseline.|Week 4, Week 24|Due to cancellation of the EXUBERA program descriptive statistics for the Patient Satisfaction of Insulin Treatment (PSIT) Questionnaire were not provided.||scores on scale||Standard Deviation|Mean
725605|NCT00348374|Secondary|Change From Baseline in Fasting and Postprandial Plasma Glucose as Determined by Standardized Meal Tolerance Tests at Week 12|Change from Baseine in fasting and postprandial plasma glucose as determined by standardized meal tolerance tests (MTT). Change = mean value at Week 12 minus mean value at Baseline. Time 0 results are for MTT (time 0) and non MTT (implied time 0) subjects.|Baseline, Week 12|FAS; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.||mg/dL||Standard Deviation|Mean
725594|NCT00348374|Secondary|Crude Hypoglycemic Event Rate|Crude event rate = (number of events)/(subject months); severe hypoglycemic events: crude event rate = (number of events)/(100 subject months). Severe = subject unable to treat self, at least 1 neurological symptom (memory loss, confusion, uncontrollable or irrational behavior, difficulty awakening, suspected seizure, loss of consciousness), and blood glucose <= 49 milligrams per deciliter (mg/dL) or unmeasured but clinical manifestestation reversed by oral carbohydrates or glucose. Non-severe events = mild-moderate.|Month 1, Month 2, Month 3, Month 4, Month 5, Month 6|Safety population; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.||events per subject months|||Number
725595|NCT00348374|Secondary|Treatment Exposure for Hypoglycemic Subjects at Each Interval of the Study: Number of Subject Months of Treatment|Subject months of treatment = number of days from start of treatment to last day of active treatment + 1 day lag (total number of subjects treated * days treated), including off-drug time)/30.44. Severity: severe = subject unable to treat self, had at least 1 neurological symptom (memory loss, confusion, uncontrollable/irrational behavior, difficulty awakening, suspected seizure, loss of consciousness), and blood glucose <= 49 milligrams/deciliter; or not measured but clinical manifestations were reversed by oral carbohydrates or glucose. Non-severe events = events that were mild or moderate.|Month 1, Month 2, Month 3, Month 4, Month 5, Month 6|Safety population: all subjects who received at least one dose of study medication; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.||subject months of treatment|||Number
725596|NCT00348374|Secondary|Number of Total Hypoglycemic Events|Total number and severity of hypoglycemic events. Severe events = subject unable to treat self, at least 1 neurological symptom (memory loss, confusion, uncontrollable or irrational behavior, difficulty awakening, suspected seizure, loss of consciousness), and blood glucose <= 49 milligrams per deciliter (mg/dL) or not measured but clinical manifestations reversed by oral carbohydrates or glucose. Non-severe events = events that were mild or moderate.|Month 1, Month 2, Month 3, Month 4, Month 5, Month 6|Safety population: all subjects who received at least one dose of study medication; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.||events|||Number
725597|NCT00348374|Secondary|Number of Subjects With Hypoglycemic Events|Severe event = subject unable to treat self, at least 1 neurological symptom (memory loss, confusion, uncontrollable/irrational behavior, difficulty awakening, suspected seizure, loss of consciousness), and blood glucose <= 49 milligrams per deciliter (mg/dL) or not measured but clinical manifestations reversed by oral carbohydrates or glucose. Non-severe events = events that were mild-moderate.|Month 1, Month 2, Month 3, Month 4, Month 5, Month 6|Safety population: all subjects who received at least one dose of study medication; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.||participants|||Number
725598|NCT00348374|Secondary|Baseline Prandial Insulin Dose (at Each Meal) at Each Visit|Dose of inhaled insulin prior to each meal at each visit.|Week 0, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24|Safety population: all subjects who received at least one dose of study medication; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation.||mg||Standard Deviation|Mean
725599|NCT00348374|Secondary|Change From Baseline in Insulin Glargine Dose at Each Visit (Office and/or Phone)|Change from Baseline in insulin glargine at each visit. Change = mean at observation minus mean Baseline observation. Basal dose = injection of basal insulin (IU) (insulin glargine).|Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24|Safety population: all subjects who received at least one dose of study medication; Lispro international units (IU) were converted to milligrams (mg) equivalent; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.||IU||Standard Deviation|Mean
725600|NCT00348374|Secondary|Change From Baseline in Fasting Plasma Lipids|Change from baseline in fasting plasma lipids at Week 12 and Week 24. Change = observation mean minus Baseline mean.|Baseline, Week 12, Week 24|FAS; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.||mg/dL||Standard Deviation|Mean
725601|NCT00348374|Secondary|Change From Baseline Weight at Each Visit|Change = mean body weight at observation minus mean body weight at Baseline.|Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24|FAS; LOCF (all visits except Baseline); N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.||kilograms||Standard Deviation|Mean
725602|NCT00348374|Secondary|Number of Subjects With Change From Baseline in Fasting and Postprandial Markers of Cardiovascular (CV) Risk as Determined by Standardized Meal Tolerance Tests|Cardiovascular risk markers included serum high-sensitivity C-reactive protein (hs-CRP)[mg/L], leptin (ng/mL), adiponectin (ug/mL), and spot urine microalbumin. Change = observation of mean fasting and postprandial markers of cardiovascular risk at Week 12 and Week 24 minus mean Baseline observation.|Week 12, Week 24|Due to cancellation of the EXUBERA program, too few patients participated to explore the markers of cardiovascular (CV) risks so these markers were not summarized.||participants|||Number
725603|NCT00348374|Secondary|Change From Baseline in Fasting and Postprandial Lipids as Determined by Standard Meal Tolerance Tests|Change from Baseline in fasting and postprandial lipids at Week 12 and Week 24 as determined by standard meal tolerance tests. Change = value at observation minus value at Baseline. Postprandial = 120 mins after meal.|Baseline, Week 12, Week 24|FAS; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.||mg/dL||Standard Deviation|Mean
725604|NCT00348374|Secondary|Change From Baseline in Fasting and Postprandial Plasma Glucose as Determined by Standardized Meal Tolerance Tests at Week 24|Change from Baseline in fasting and postprandial plasma glucose as determined by standardized meal tolerance tests (MTT). Change = mean value at Week 24 minus mean value at Baseline. Time 0 results are for MTT (time 0) and non MTT (implied time 0) subjects.|Baseline, Week 24|FAS; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.||mg/dL||Standard Deviation|Mean
725606|NCT00348374|Secondary|Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles|Mean change from Baseline in fasting and 2-hour postprandial glucose at each visit in 8-point self-monitored blood glucose (SMBG) profiles: includes values prior to each meal (breakfast, lunch and dinner), 2 hours after each meal, at bedtime, and at 2:00 ante meridiem (a.m.) Change=observation value minus Baseline value.|Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24|FAS; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.||mg/dL||Standard Deviation|Mean
725607|NCT00348374|Secondary|Subjects That Attained Glycosylated Hemoglobin A1c (HbA1c) Target Levels of <7%, < 6.5%, and < 6.0% Without an Episode of Severe Hypoglycemia at Week 24|Number of subjects that attained HbA1c target levels of <7%, < 6.5%,and <6.0% at Week 24 without an episode of severe hypoglycemia.|Week 24|FAS; N=number of subjects with evaluable data at Baseline; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.||participants|||Number
725608|NCT00348374|Secondary|Subjects That Attained Glycosylated Hemoglobin A1c (HbA1c) < 7.0%, < 6.5% and < 6.0% at Week 24|Number of subjects acheiving glycemic control: HbA1c target levels of <7.0%, <6.5%, and <6.0% at Week 24.|Week 24|FAS; N=number of subjects with evaluable data at Baseline; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.||participants|||Number
725609|NCT00348374|Secondary|Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Each Visit|Change in mean glycosylated hemoglobin A1c (HbA1c %) from Baseline to each visit through Week 24. Change = mean value at observation minus mean value at Baseline.|Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24|FAS; LOCF; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.||percent||Standard Deviation|Mean
725610|NCT00348374|Primary|Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at End of Treatment|Change from Baseline in glycosylated hemoglobin A1c (HbA1c %) at Week 24. Change = mean value at Week 24 minus mean value at Baseline.|Baseline, Week 24 (End of Treatment)|Full analysis set (FAS): subjects who received at least one dose of study medication, had a baseline glycosylated hemoglobin A1c (HbA1c%) measurement, and had a post-baseline HbA1C measurement; last (post-baseline) observation carried forward (LOCF). Number of subjects with HbA1c values at Baseline and Week 24: Exubera® n=81, Lispro n=90.||percent||Standard Deviation|Mean
725611|NCT00353977|Primary|Cellular Immune Response in Vaccine Recipients|Evaluate the efficacy of an accelerated ALVAC-pp65 immunization schedule in generating cytomegalovirus (CMV)-specific immunity in seronegative transplant donors and healthy volunteers (HV) and augmenting CMV-specific immunity in seropositive transplant donors.|Day 45|11 subjects were CMV seropositive and 3 subjects were seronegative.||participants|||Number
725612|NCT00354029|Primary|NRS Pain = Numeric Rating Scale (0-10)|The numeric rating scale (NRS) is used to measure the intensity of pain. The value 0 means no pain and the value 10 represents maximal pain. a higher intensity of pain is associated with a worse outcome.|24 hours|||Units on a scale||Standard Deviation|Mean
725613|NCT00354107|Secondary|Minimal Residual Disease by Using Southern Blotting or by Real-time Polymerase Chain Reaction (PCR)|NPM-ALK expression will be summarized using appropriate descriptive statistics and reported with associated exact 95% confidence intervals.|At baseline and weeks 5 and 11||||||
725614|NCT00354107|Secondary|Development of Human Antichimeric Antibodies by Using ELISA Method|Change in level from baseline to week 11 will be summarized using appropriate descriptive statistics and reported with associated exact 95% confidence intervals.|Change from baseline to week 11||||||
725615|NCT00354107|Secondary|CD30 Concentrations Levels as Assessed by ELISA|Summarized using appropriate descriptive statistics and reported with associated exact 95% confidence intervals. Although the limited sample size precludes formal hypothesis testing, exploratory analysis of the association between soluble CD30 levels and PK parameters and response will be performed.|At baseline||||||
725616|NCT00354107|Secondary|Pharmacokinetics of Monoclonal Antibody SGN-30 Assessed by Enzyme-linked Immunosorbent Assay (ELISA) Methods||At baseline, at weeks 1, 2, 5, 6, and 11||||||
725617|NCT00354107|Primary|Response|Anti tumor activity as assessed by computed tomography of neck/chest/abdomen/pelvis, positron emission tomography scan and/or gallium scan. Assessed by physical examination appropriate imaging studies. Bone marrow aspirate/biopsy must be normal and any macroscopic nodules in any organs detectable on imaging techniques should no longer be present. Gallium scans must be negative if initially positive.|Week 4|||percent|||Number
725618|NCT00354159|Secondary|Characterize Arrhythmic Events|The rate of spontaneous VT (ventricular tachycardia)/VF (ventricular fibrillation) episodes during the 12-month follow-up period in episodes per subject month was compared between the Treatment Arm and the Control Arm|12 months post implant|All 399 subjects successfully implanted with the Chronicle ICD were included in the analysis.||VT/VF episodes per subject month||95% Confidence Interval|Number
725619|NCT00354159|Secondary|Characterize Quality of Life at Baseline and 12-month Visit|The outcome is the change in the Minnesota Living with Heart Failure® (MNLWHF) questionnaire response from baseline to the 12-month follow-up visit. The MNLWHF questionnaire is a 21 question questionnaire scored from zero (no impact of heart failure) to 5 (severe impact of heart failure). The composite MNLWHF score ranges from 0 (no impact of heart failure) to 105 (severe impact of heart failure). Change in MNLWHF score was computed as the 12-month minus the baseline score.|baseline to 12 months post implant|Subjects were required to respond to the baseline and 12-month follow-up visit to be included in the analysis.||scores on a scale||Standard Deviation|Mean
725620|NCT00354159|Secondary|Characterize Defibrillation Threshold Testing Efficacy (Chronicle ICD Subjects Only)|The outcome measure is the percentage of subjects implanted with the Chronicle ICD who completed defibrillation testing and had a 10 Joule safety margin|Implant|Of the 406 subjects with an attempted implant of the Chronicle ICD system, 366 completed defibrillation testing.||percentage of subjects||95% Confidence Interval|Number
725621|NCT00354159|Secondary|Characterize Intracardiac Pressure Monitoring Following Defibrillation Testing (Chronicle ICD Subjects Only)|Intracardiac pressure monitoring was deemed successful following defibrillation testing if physiological pressure waveforms were present following defibrillation testing.|implant|Of the 406 subjects with an attempted implant of the Chronicle ICD system, 366 completed defibrillation testing as part of their ICD implant procedure.||Percentage of subjects with waveforms||95% Confidence Interval|Number
725622|NCT00354159|Secondary|Characterize Renal Function at the Baseline and 12-month Visit|Change in estimated glomerular filtration rate (eGFR) from baseline to the 12-month follow-up visit. eGFR was estimated using the MDRD forumula from the National Kidney Foundation (American Journal of Kidney Diseases 39: S1-299). Change in eGFR was computed as the 12-month eGFR value minus the baseline eGFR value. Positive values indicate an increase in eGFR from baseline and negative values indicate a decrease in eGFR from baseline.|baseline to 12 months post implant|Subjects were required to have creatinine values available at the baseline and 12-month visit to be included in the analysis of this objective.||mL/min/1.73 m^2||Standard Deviation|Mean
725623|NCT00354159|Secondary|Characterize Distance Walked in Six Minutes|The outcome is the change in distance walked in 6-minutes in meters between the baseline visit and the 12-month follow-up visit. The change in distance walked was calculated within each subject as the distance walked in 6-minutes at the 12-month visit minus the distance walked in 6-minutes at the baseline visit. Positive values indicate an increase in the distance walked in 6-minutes from baseline.|baseline to 12 months post implant|Subjects were required to complete the 6-minute hall walk test at both the baseline and 12-month visit to be included in the analysis of this objective.||distance walked in 6-minutes (meters)||Standard Deviation|Mean
725624|NCT00354159|Secondary|Characterize NYHA Functional Class|The outcome is the change in NYHA functional class between the baseline visit and the 12-month follow-up visit. At baseline subjects were required to be NYHA functional class II or III. The outcome will show the percentage of subjects that were functional class II and III at baseline and functional class I, II, III, or IV at the 12-month visit. The percent improvement from baseline is calculated as the percentage of subjects with a lower NYHA functional class at the 12-month visit compared to their NHYA functional class at baseline.|baseline to 12 months post implant|Subjects were required to have an NYHA functional class assessment at the baseline and 12-month follow-up visit to be included in this analysis.||percentage of subjects|||Number
725625|NCT00354159|Secondary|Characterize Intracardiac Pressure Changes in Response to Subject Clinical Signs and Symptoms of Heart Failure Events|The average daily median estimated pulmonary arterial diastolic pressure (ePAD) was computed for each subject with at least 90 days of ePAD data available and compared between the Control Arm subjects with and without a heart failure related event during the 12-month randomized period.|12 months post implant|All Control Arm subjects with at least 90 days of pressure data available during the 12-month randomized follow-up period.||ePAD mm Hg||Standard Deviation|Mean
725626|NCT00354159|Secondary|Characterize Intracardiac Pressure|The average daily median estimated pulmonary arterial diastolic pressure (ePAD) was computed for each subject with at least 90 days of ePAD data available and compared between the Treatment and Control arms.|12 months post implant|At least 90 days of ePAD data were required for each subject during the 12-month randomized period to be included in the analysis.||ePAD mm Hg||Standard Deviation|Mean
725627|NCT00354159|Secondary|Characterize Medication Usage|The rate of change of cardiovascular medications in changes per subject month were computed and compared between treatment groups.|12 months post implant|All randomized subjects.||Medication changes per subject month|||Number
725628|NCT00354159|Secondary|Characterize Subject Survival|Death from any cause during the 12-month randomization period|12 months post implant|All randomized subjects.||number of deaths|||Number
725629|NCT00354159|Secondary|Characterize Randomized Days Alive Out of Hospital|Randomized days alive outside of the hospital was computed for each subject as the total number of randomized days minus the number of randomized days spent in the hospital for any cause.|12 months post implant|All randomized subjects.||Days||Standard Deviation|Mean
725630|NCT00354159|Secondary|Characterize Health Resource Utilization|Percentage of randomized days spent in the intensive care unit for heart failure. Reason for hospitalization was determined by the adverse event adjudication committee.|12 months post implant|All randomized subjects.||percentage of randomized days||Full Range|Mean
725631|NCT00354159|Secondary|Percentage of Randomized Subjects at Each Level of the Composite Response Endpoint Between the Treatment Arm and the Control Arm.|"The definitions of worsened, improved, and unchanged are as follows:
Worsened: Subject dies, is hospitalized for worsening heart failure, permanently discontinues blinded randomized assignment and has worsening heart failure at time of study discontinuation, demonstrates worsening NYHA Class at LOCF, or moderate-marked worsening of global assessment score at LOCF.
Improved: Subject has not worsened, and demonstrates improvement in NYHA class and/or moderate-marked improvement in subject global assessment score.
Unchanged: Subject is neither worsened nor improved."|12 months post implant|All randomized follow-up from all randomized subjects were included.||Percent of Subjects|||Number
725632|NCT00354159|Secondary|Relative Risk of All-cause Events|All-cause events were defined as hospitalizations, hospitalizations <24 hours necessitating intravenous therapy, emergency department visits necessitating intravenous therapy or urgent visits necessitating intravenous therapy.|12 months post-implant|All randomized follow-up from all randomized subjects||All cause event rate per year||95% Confidence Interval|Mean
725633|NCT00354159|Secondary|Freedom From All Cause Death or Heart Failure Hospitalization|Death from any cause or heart failure related hospitalization greater than 24 hours during the 12-month randomized period|12 months post-implant|All randomized subjects||Number of subjects meeting endpoint|||Number
725634|NCT00354159|Secondary|Relative Risk Reduction of Cardiovascular Related Events in the Treatment Group Compared to the Control Group|The rate of CV-related events (hospitalizations >24h, hospitalizations <24h with IV therapy, ED visits with IV therapy, and urgent clinic visits with IV therapy) during the 12-month randomized follow-up period was compared between the Chronicle and Control groups.|12 months post-implant|All randomized follow-up for all randomized subjects.||Cardiovascular related events per year||95% Confidence Interval|Mean
725635|NCT00354159|Secondary|Cumulative Days in the Hospital for Heart Failure|The endpoint for this objective was defined as the cumulative days in hospital for heart failure (HF) expressed as a percentage of hospital free follow-up days during the 12-month randomized period. The relatedness of the events was based on the primary reason for which the subject was originally admitted to the hospital or seen in the emergency department or at an urgent visit, not on the development of new events that occur during hospitalization.|12 months post-implant|All follow-up from all randomized subjects were included in this analysis.||Percent days in hospital||Full Range|Median
725654|NCT00354341|Secondary|Percentage of Participants With Stable Hb Levels Between 13 to 15 g/dL||Week 26 up to Week 64|ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.||percentage of participants||95% Confidence Interval|Number
725636|NCT00354159|Primary|Relative Risk Reduction of All Heart Failure Related Events in the Treatment Group Compared to the Control Group|The rate of HF-related events (hospitalizations >24h, hospitalizations <24h with IV therapy, ED visits with IV therapy, and urgent clinic visits with IV therapy) during the 12-month randomized follow-up period was compared between the Chronicle and Control groups.|12 months post-implant|All randomized subjects||Heart failure related events per year||95% Confidence Interval|Mean
725637|NCT00354159|Primary|Percent of Subjects With an Attempted Chronicle IHM Implant Free From Chronicle IHM System-related Complications at 6-months Post-implant|A Chronicle IHM system-related complication was defined as any system-related adverse event that occurred during the clinical investigation which is (1) treated with invasive means (including intravenous drug therapy), (2) results in death or serious injury of subject, (3) results in the explant of any Chronicle IHM component,and/or (4) causes permanent loss of significant function of the implanted system.|6 months post implant|All subjects with an attempted implant of the Chronicle IHM system were included in this analysis. At the time the study stopped, there was only one subject with an attempted Chronicle IHM implant. Thus this objective was not analyzed.||Percent of Chronicle IHM subjects||Full Range|Mean
725638|NCT00354159|Primary|Percent of Subjects With an Attempted Implant of the Chronicle ICD System Free From System-related Chronicle ICD Complications at 6-months Post-implant.|A Chronicle ICD system-related complication was defined as any system-related adverse event that occurred during the clinical investigation which is (1) treated with invasive means (including intravenous drug therapy), (2) results in death or serious injury of subject, (3) results in the explant of any Chronicle ICD component,and/or (4) causes permanent loss of significant function of the implanted system.|Within 6 months post-implant|All 406 subjects with an attempted implant of the Chronicle ICD system.||Percentage of Chronicle ICD Subjects||95% Confidence Interval|Number
725655|NCT00354341|Secondary|Left Ventricular Ejection Fraction (LVEF)|LVEF was calculated as ([LVEDV - LVESV], divided by LVEDV) multiplied by 100; where LVEDV = left ventricular end diastolic volume (in mL), LVESV = left ventricular end systolic volume (in mL). LVEF is expressed in percentage of LVEDV.|Baseline, Months 6 and 15|ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category, for respective arm groups.||percentage of LVEDV||Standard Deviation|Mean
725656|NCT00354341|Secondary|Fractional Myocardial Shortening (FS)|FS was calculated as: ([LVEDD – LVESD] divided by LVEDV) multiplied by 100; where LVEDD = left ventricular end diastolic diameter (in centimeters [cm]), LVESD = left ventricular end systolic diameter (in cm), LVEDV = left ventricular end diastolic volume (in mL). FS is expressed in percentage of LVEDV.|Baseline, Months 6 and 15|ITT population. Here “n”= participants who were evaluable for each category, for respective arm groups.||percentage of LVEDV||Standard Deviation|Mean
725657|NCT00354341|Secondary|Left Ventricular End Diastolic Volume Index (LVEDVI)|LVEDVI was calculated by dividing left ventricular end diastolic volume (LVEDV) (in mL) BSA (in m^2). LVEDVI was presented in mL/m^2.|Baseline, Months 6 and 15|ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category, for respective arm groups.||mL/m^2||Standard Deviation|Mean
725658|NCT00354341|Secondary|Left Ventricular End Systolic Volume Index (LVESVI)|LVESVI was calculated by dividing left ventricular end systolic volume (LVESV) (in milliliters [mL]) with body surface area (BSA) (in meter square [m^2]). LVESVI is presented in milliliter per meter square (mL/m^2).|Baseline, Months 6 and 15|ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category, for respective arm groups.||mL/m^2||Standard Deviation|Mean
725659|NCT00354341|Primary|Change From Baseline in Left Ventricle Mass Index (LVMI) at Month 15|LVMI (in g/m^2) = (0.8 [1.04 {(LVEDD + IVS + PWT)^3 – (LVEDD)^3}] + 0.6) divided by BSA. Here, LVEDD = left ventricular end diastolic diameter (in centimeters [cm]); PWT = left ventricular posterior wall thickness in diastole (in cm); IVS = interventricular septal wall thickness in diastole (in cm). Echocardiogram was performed at baseline and Month 15 to interpret LVMI which was expressed in grams per meter square (g/m^2).|Baseline, Month 15|ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.||g/m^2||Standard Deviation|Mean
725660|NCT00354432|Secondary|Quality of Life|Quality of life is quantified by the Functional Assessment of Cancer Therapy - Prostate questionnaire (FACT-P). The FACT-P consists of four general subscales (functional, emotional, social, and physical) consisting of a total of 27 questions as well as a Prostate specific subscale consisting of 12 questions. Each question is answered on a 0 to 4 scale. The FACT-P score ranges from 0 to 156; higher scores denote better quality of life.|12 weeks|Participants with baseline and 12 week quality of life data.||units on a scale||Standard Error|Least Squares Mean
725661|NCT00354432|Primary|Hot Flash Symptom Severity Score|The primary objective of this randomized trial is to assess the effect of soy and Venlafaxine on the hot flash symptom severity score in men undergoing hormonal manipulation for treatment of prostate cancer. Hot flash severity will be quantitated using the symptom diary (as the sum of the number of hot flashes (any number greater than or equal to 0) times their severity (0=none, 1=mild, 2=moderate, 3=severe)). The primary end point is the 12 week hot flash score relative to the baseline value (i.e., 100*(12 week score)/baseline score). The range is 0 to infinity. Lower values represent a better outcome.|12 weeks|All randomized participants were analyzed in a repeated measures mixed model. This allowed inclusion of all study participants.||percent of baseline score||Standard Error|Least Squares Mean
725662|NCT00354484|Primary|Reported Adverse Events||anytime between baseline and end of study or time to intervention||||||
725663|NCT00354484|Primary|Number of Patients Classified as a 'Clinical Success'. Clinical Success Was Defined as the Number of Subjects With an Increase in Hemoglobin of >12 g/dL||anytime between baseline and end of study or time to intervention|||participants|||Number
725664|NCT00354601|Primary|Objective Tumor Response|The number of partial and complete responders among all evaluable patients as defined using Response Evaluation Criteria in Solid Tumors guidelines|8 weeks|unable to measure due to failure to complete|||||
725665|NCT00354601|Secondary|Quality of Life|comparison of treatment end to pre entry and day 1 of each treatment cycle.|Pre-entry, day 1, treatment end|neither patient completed study|||||
725666|NCT00354601|Secondary|Number of Participants With Grade 3 or Higher Toxicity|summary of grade 3 (per Common Toxicity Criteria) or higher toxicities which generally is described as a severe adverse reaction or symptom.|Days 1, 8, 15, 21 of each course and treatment end (28 days after last dose or start of new therapy)|tracked during incomplete treatment period||participants|||Number
725667|NCT00354601|Secondary|Time to Progression|Progression is defined as a 20% increase in tumor size of all the target lesions along the longest diameter|Evaluated every 8 weeks during treatment|unable to analyze due to failure to complete treatment or study|||||
725668|NCT00354614|Primary|Sensitivity and Specificity|Comparison of sensitivity and specificity of ApneaLink to polysomnography with an apnea hypopnea index (AHI) cut-off of 15 or greater|Simultaneous single night recording|||percentage|||Number
725669|NCT00354640|Secondary|Change in Serum Estradiol Levels|The change in serum concentrations of estradiol at baseline and 14 days was measured.|Baseline and 14 days|Participants with blood samples for trough concentrations were included.||pmol/l||Full Range|Median
725670|NCT00354640|Primary|Change in Blood Concentrations|The change in blood concentrations of anastrozole at baseline and 14 days was measured.|Baseline and 14 days|Participants with blood samples for trough concentrations were included.||ng/ml||Full Range|Median
725671|NCT00354679|Primary|Evaluation of Safety and Toxicity|All toxicity will be graded according to the National Cancer Institute (NCI) Common Toxicity Criteria v3.0.|2 years|||participants|||Number
725672|NCT00354744|Secondary|Toxicity|Assess immediate- and short-term toxicities of concurrent irinotecan hydrochloride and radiotherapy in these patients|2 years||||||
725673|NCT00354744|Secondary|Feasibility|Determine the feasibility of concurrent irinotecan hydrochloride and radiotherapy in these patients.|2 years||||||
725753|NCT00355394|Secondary|Change in Headache Intensity as Measured by the NRS Score From Baseline to the One Hour Assessment.|The NRS is a 0 to 10 point scale with 0 representing no headache and 10 representing severe headache.|1 hours|All participants included.||NRS Score||Standard Deviation|Mean
725674|NCT00354744|Secondary|Early Disease Control|Improve the early disease control interval for patients with newly diagnosed, high-risk, metastatic rhabdomyosarcoma or ectomesenchymoma using intensive, interval-compression therapy (comprising vincristine, irinotecan hydrochloride, ifosfamide, etoposide, doxorubicin hydrochloride, cyclophosphamide, and dactinomycin) that permits maximal early exposure to known effective agents.|2 years||||||
725675|NCT00354744|Primary|Estimate of the Percent of Patients Event Free at 4 Years Following Study Entry|Event-free survival: Time to recurrence or death as a first event estimated from a Kaplan Meier curve.|4 years|All eligible patients||percent of participants||95% Confidence Interval|Number
725676|NCT00354744|Primary|Tumor Response Rate|Volumetric measurements of the primary tumor using an elliptical model (0.5 x the product of the 3 largest perpendicular diameters) to assess response to neoadjuvant therapy. The RECIST (Response Evaluation Criteria in Solid Tumors) from the NCI will be used for assessment of the size of measurable metastases, including nodal metastases. Primary Tumor Measurement: Technical guidelines for cross-sectional imaging computed tomography (CT) slice thickness should be 5mm or less and the diameter of the “measurable” mass should be at least twice the reconstructed slice thickness. Smaller masses are considered detectable, but will be counted as “non-measurable.” Complete Response (CR): Complete disappearance of the tumor confirmed at >4 weeks. Partial Response (PR): At least 64% decrease in volume compared to the measurement obtained at study enrollment. Progressive Disease (PD): At least 40% increase in tumor volume compared to the smallest volume obtained since the beginning.|Protocol week 6 evaluation|All eligible patients with protocol week tumor assessment (N=102)||percent of participants|||Number
725677|NCT00354770|Primary|Massachusetts General Hospital Hairpulling Scale|There is no minimum or maximum score to quantify 'good' or 'poor' improvement based on this scale. The total score can range from 0-28 with zero being no problems to 28 being the most severe score one can receive.A total of 6 assessments were made, however only the final score (the score at the final visit after 12 weeks) was reported here to show the final outcome measure that was used in the final report of possible improvement and what was reported for final publication of data.|Baseline and final visit after 12 weeks|||units on a scale||Standard Deviation|Mean
725678|NCT00354835|Secondary|Incidence of Bladder Dysfunction|Number of patients with a summary score greater than 8.5|3-6 years after enrollment|470 participants were excluded due to ineligibility or absence of the dysfunctional voiding and incontinence symptoms questionnaire.||Participant|||Number
725679|NCT00354835|Secondary|Event Free Survival (EFS) by PAX Status||4 years|Only eligible patients who were tested for their fusion status and PAX partners.||Probability||95% Confidence Interval|Number
725680|NCT00354835|Secondary|Toxicity With GSTA1 and CYP2C9 Genotypes|Incidence of toxicity related to VAC treatment in patients with GSTA1 and CYP2C9 genotypes.|During the study|The analysis was abandoned due to low incidence of toxicity. Data were not collected.|||||
725681|NCT00354835|Secondary|Toxicity With CYP2B6 Genotypes|Incidence of toxicity related to VAC treatment in patients with CYP2B6 genotypes.|During the study|The analysis was abandoned due to low incidence of toxicity. Data were not collected.|||||
725682|NCT00354835|Secondary|Incidence of Toxicity Related to VI Treatment in Patients With UGT1A1 Genotype|Severe and undesirable adverse event is considered as grade 3; Life-threatening or disabling adverse event is grade 4. Grade 4 is worse than grade 3.|Weeks 4-9 (the first exposure to VI)|Ineligible patients are excluded. Only patients tested for the UGT1A1 genotypes are reported and included in this analysis.||Counts|||Number
725683|NCT00354835|Secondary|Compare Event Free Survival (EFS) With Respect to the Level of % Change in FDG PET Maximum Standard Uptake Value (SUVmax) at Week 15|4-year EFS (probability of no relapse, secondary malignancy, or death after 4 years in the study)|4 years|421 participants were excluded due to ineligibility or absence of SUVmax evaluation at baseline and week 15.||Probability||95% Confidence Interval|Number
725684|NCT00354835|Secondary|Compare Event Free Survival (EFS) With Respect to the Level of % Change in FDG PET Maximum Standard Uptake Value (SUVmax) at Week 4|4-year EFS (probability of no relapse, secondary malignancy, or death after 4 years in the study).|4 years|452 participants were excluded due to ineligibility or absence of SUVmax evaluation at baseline and week 4.||Probability||95% Confidence Interval|Number
725685|NCT00354835|Secondary|Acute and Late Effects of VAC as Delivered on This Study to D9803 VAC|The toxicity rates will be estimated for each phase and course of treatment, and will be compared to the fixed rates under D9803 using one-sided lower confidence intervals for a single proportion without adjustment for multiple comparisons.|Up to 43 weeks|Number of patients with specific adverse events.||participants|||Number
725686|NCT00354835|Secondary|Incidence of Toxicity|Grade 3 or 4 nausea, diarrhea, dehydration, radiation dermatitis, mucositis due to radiation. Severe and undesirable adverse event is considered as grade 3; Life-threatening or disabling adverse event is grade 4. Grade 4 is worse than grade 3.|Up to 15 weeks|||Probability||95% Confidence Interval|Number
725687|NCT00354835|Secondary|Overall Survival (OS) Probability VAC and Early (Week 4) Radiotherapy Compared to Delayed (Week 10) Radiotherapy, Using IRSIV for Historic Comparison|Compare 4-year OS using eligible participants only to the historical rate of 0.70 with IRSI-V. The 4-year OS is probability of being alive after 4 years in the study. The Delayed (Week 10) Radiotherapy is from IRSI-V, and the number of participants of IRSI-V is unknown, but we have the rate of 0.70.|4 years|17 ineligible participants were excluded.||Probability||95% Confidence Interval|Number
725688|NCT00354835|Secondary|Local Failure|Compare 2-year local failure rate to the historical rate of 0.13 with IRSI-V. The Delayed (Week 10) Radiotherapy is from IRSI-V, and the number of participants of IRSI-V is unknown, but we have the rate of 0.13.|2 years|17 ineligible participants were excluded.||Proportion of participants||95% Confidence Interval|Number
725689|NCT00354835|Secondary|Event Free Survival (EFS) Probability VAC and Early (Week 4) Radiotherapy Compared to Delayed (Week 10) Radiotherapy, Using IRSIV for Historic Comparison|Compare 4-year EFS using eligible participants only to the historical rate of 0.65 with IRSI-V. The 4-year EFS is probability of no relapse, secondary malignancy, or death after 4 years in the study. The Delayed (Week 10) Radiotherapy is from IRSI-V, and the number of participants of IRSI-V is unknown, but we have the rate of 0.65.|4 years|17 ineligible participants were excluded.||Probability||95% Confidence Interval|Number
725690|NCT00354835|Primary|Overall Survival (OS)|Probability of being alive after 4 years in the study.|4 years|||Probability||95% Confidence Interval|Number
725754|NCT00355394|Secondary|The Number of Subjects With a NRS Score of Zero at 24 Hours.|The NRS is a 0 to 10 point scale with 0 representing no headache and 10 representing severe headache.|24 hours|||participants|||Number
725691|NCT00354835|Primary|Response Rate (RR)|Proportion of patients with complete or partial response. Complete Response (CR): Complete disappearance of the tumor confirmed at > 4 weeks; Partial Response (PR): At least 64% decrease in volume compared to the baseline; Overall Response (OR) = CR + PR.|Reporting Period 1 (Weeks 1 - 15)|||Proportion||95% Confidence Interval|Number
725692|NCT00354835|Primary|Event Free Survival (EFS)|Probability of no relapse, secondary malignancy, or death after 4 year in the study|4 years|||Probability||95% Confidence Interval|Number
725693|NCT00354887|Primary|Number of Participants With Overall Response|Overall response rate defined as Complete Response (CR), disappearance of all target lesions; or Partial Response (PR), at least a 30% decrease in sum of longest diameter (LD) of target lesions, taking as reference the baseline sum LD, assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000]. In addition to a baseline scan, confirmatory scans for those deemed to have achieved a PR or CR.|Every 9 weeks from treatment initiation and confirmatory images 6 weeks or more after initial responses|Analysis was intent-to-treat; One patient developed an acute flare of Crohn’s disease after one cycle of study treatment and was removed from study without undergoing restaging scans.||participants|||Number
725694|NCT00354913|Secondary|Objective Response Rate|Percentage of participants with an objective response (complete response or partial response). Per modified Macdonald criteria and assessed by MRI, complete response (CR) was the disappearance of all target lesions and partial response (PR) was a ≥50% decrease in the sum of the longest diameter of target lesions. Objective response = CR+PR.|69 Months|Intent-to-treat||percentage of participants|||Number
725695|NCT00354913|Secondary|Median Overall Survival (OS)|Time in months from the start of study treatment to date of death due to any cause. Patients alive at last follow-up are censored as of that follow-up date. Median OS was estimated using a Kaplan-Meier curve.|From the date of study treatment initiation to the date of death from any cause, assessed up to 69 months.|Intent-to-treat||months||95% Confidence Interval|Median
725696|NCT00354913|Secondary|Median Progression-free Survival (PFS)|Time in months from the start of study treatment to the date of first progression according to Macdonald criteria, or to death due to any cause. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve.|From the date of study treatment initiation to the date of the first documented progression or death from any cause, whichever came first, assessed up to 69 months.|Intent-to-treat||months||95% Confidence Interval|Median
725697|NCT00354913|Primary|Progression-free Survival at 6 Months|Percentage of participants surviving six months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to the Macdonald criteria, or death due to any cause.|From the date of study treatment initiation to the date of the first documented progression or death from any cause, whichever came first, assessed up to 69 months. For each participant, PFS was assessed at 6 months after treatment initiation.|Intent-to-treat||percentage of participants||95% Confidence Interval|Number
725698|NCT00354978|Primary|Median Progression-free Survival (PFS)|PFS is defined as the duration of time from start of treatment to time of disease progression using Kaplan-Meier median PFS time.|From baseline until first documented progression or death from any cause, whichever came first, assessed up to 75 months|Analysis per protocol.||Months||95% Confidence Interval|Median
725699|NCT00355030|Secondary|Bone Age|Bone age measured using the X-Ray of left hand and wrist.|Baseline through End of Study (up to 9 years)|All participants who received at least one dose of study drug with at least one follow up visit. The safety follow up participants did not reach final height at end of Period 1 unless final height is noted for participants that reached final height at the end of Period 1.||years||Standard Deviation|Mean
725700|NCT00355030|Secondary|Percentage of Children With Normal Adult Height SDS|Percentage of children with normal adult height SDS (greater than -2 SDS and less than +2 SDS)|Baseline through End of Study (up to 9 years)|All participants who received at least one dose of study drug with at least one follow up visit.||percentage of participants|||Number
725701|NCT00355030|Secondary|Difference Between Adult Height SDS and Baseline Height SDS|"This is the difference between the gender, age and country matched standard deviation score of adult height and standard deviation score of baseline height for particular participant.
The height of the participants were measured barefoot using a standard wall-mounted Harpenden stadiometer. SDS report the number of standard deviations from the mean for age and sex for an individual measurement (normal range: -2 to +2 SDS). Height SDS is derived by subtracting the population mean from individual's height value and then dividing that difference by the population standard deviation. Greater height SDS values indicate greater height."|Baseline through End up Study (up to 9 years)|All participants who received who reached final height.||standard deviation score||Standard Deviation|Mean
725702|NCT00355030|Secondary|Difference Between Adult Height SDS and Baseline Predicted Height SDS|"This is the difference between the gender, age and country matched standard deviation score of adult height and standard deviation score of baseline predicted height [calculated using the Bayley-Pinneau method based on height and bone age] for particular participant.
The height of the participants were measured barefoot using a standard wall-mounted Harpenden stadiometer. SDS report the number of standard deviations from the mean for age and sex for an individual measurement (normal range: -2 to +2 SDS). Height SDS is derived by subtracting the population mean from individual's height value and then dividing that difference by the population standard deviation. Greater height SDS values indicate greater height."|Baseline through End up Study (up to 9 years)|All participants who received who reached final height.||standard deviation score||Standard Deviation|Mean
725703|NCT00355030|Secondary|Difference Between Adult Height SDS and Target Height SDS|"This is the difference between the gender, age and country matched standard deviation score of adult height and standard deviation score of target height [calculated as (mother’s height (SDS) + father’s height (SDS))/2] for particular participant.
The height of the participants were measured barefoot using a standard wall-mounted Harpenden stadiometer. SDS report the number of standard deviations from the mean for age and sex for an individual measurement (normal range: -2 to +2 SDS). Height SDS is derived by subtracting the population mean from individual's height value and then dividing that difference by the population standard deviation. Greater height SDS values indicate greater height."|Baseline through End of Study (up to 9 years)|All participants who received who reached final height.||standard deviation score||Standard Deviation|Mean
725704|NCT00355030|Secondary|Height SDS|SDS report the number of standard deviations from the mean for age and sex for an individual measurement (normal range: -2 to +2 SDS). Height SDS is derived by subtracting the population mean from individual’s height value and then dividing that difference by the population standard deviation. Greater height SDS values indicate greater height.|Baseline through End of Study (up to 9 years)|All participants who received at least one dose of study drug with at least one follow up visit. The safety follow up participants did not reach final height at end of Period 1 unless final height is noted for participants that reached final height at the end of Period 1.||standard deviation score||Standard Deviation|Mean
725705|NCT00355030|Secondary|Height Velocity|Height velocity is the difference between 2 height measurements, divided by years elapsed between measurements.|Baseline through End of Study (up to 9 years)|All participants who received at least one dose of study drug with at least one follow up visit. The safety follow up participants did not reach final height at end of Period 1 unless final height is noted for participants that reached final height at the end of Period 1.||centimeter per year||Standard Deviation|Mean
725706|NCT00355030|Primary|Adult Height Standard Deviation Score (SDS)|The height of the participants were measured barefoot using a standard wall-mounted Harpenden stadiometer. SDS report the number of standard deviations from the mean for age and sex for an individual measurement (normal range: -2 to +2 SDS). Height SDS is derived by subtracting the population mean from individual's height value and then dividing that difference by the population standard deviation. Greater height SDS values indicate greater height.|Baseline through End of Study (up to 9 years)|All participants who received at least one dose of study drug with at least one follow up visit.||standard deviation score||Standard Deviation|Mean
725707|NCT00355030|Primary|Number of Participants With One or More Drug-related Adverse Events|A drug-related AE was an AE that occurred postdose or was present predose and became more severe postdose and was considered to be related to study treatment. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.|Baseline through End of Study (up to 9 years)|All participants who received at least one dose of study drug in Period 1 and all participants who entered Period 2 (safety population).||participants|||Number
725708|NCT00355082|Secondary|The Number of Participants With at Least the Specified Change in Seizure Frequency, Compared to Baseline, at the End of Participation in the Continuation Phase (Maximum of 24 Weeks)|Change in seizure frequency was calculated as the average seizure frequency during the Continuation Phase minus the seizure frequency at Baseline.|Baseline and entire Continuation phase (24 Weeks)|All participants who entered the Continuation Phase||participants|||Number
725709|NCT00355082|Secondary|Percent Change From Baseline in the Average Seizure Frequency Measured at the End of Participation in the Continuation Phase|Change from baseline was calculated as the average seizure frequency at the end of the Continuation Phase minus the average seizure frequency at Baseline. The number of seizures during the Continuation phase divided by the number of weeks was compared to the number of seizures at Baseline. A positive number indicates a reduction in seizure frequency.|Baseline and start of Continuation phase through Week 24 or end of participation in the Continuation phase|All participants who began the Continuation Phase||percent change in seizures||Full Range|Median
725710|NCT00355082|Secondary|Number of Seizure-free Participants During the Last 12 Weeks of Treatment of the Treatment Phase|The number of participants who had no seizures during the treatment period was calculated. The last 12 weeks of treatment were either Weeks 11-22 or 12-23 depending on which background AED was being withdrawn|The last 12 weeks of treatment of the Treatment phase (Monotherapy phase - approximately Week 11 through Week 23)|All randomized participants who began withdrawal of background AED (Visit 5) minus any major protocol violators||participants|||Number
725711|NCT00355082|Secondary|Percent Change From Baseline in Weekly Seizure Frequency Between Study Visits 3 (Start of Dosing) and 9 (End of the Treatment Phase)|Change from Baseline was measured as the number of seizures at Visits 3 through 9 minus the number of seizures at Baseline. The number of partial seizures during treatment divided by the number of weeks of treatment was compared to the weekly seizure frequency during Baseline. A positive number equals a reduction in seizure frequency.|Baseline and Study Visit 3 through Visit 9 of the Treatment phase (Treatment Week 0 through Week 23)|All randomized participants who began withdrawal of background AED (Visit 5) minus any major protocol violators||percent change in seizures||Full Range|Median
725712|NCT00355082|Secondary|Percentage of Participants Meeting Escape Criteria in the Treatment Phase|The percentage of participants meeting Escape Criteria was calculated as the number of participants who met an Escape Criterion divided by the number who had reached Visit 5 minus major protocol violators. Escape Criteria are: (1) doubling of average monthly seizure frequency; (2) doubling of the highest consecutive 2-day seizure total; (3) occurrence of a new, more severe seizure type; or (4) worsening of generalized tonic-clonic seizures.|Study Visit 5 through Visit 9 of the Treatment phase (approximately Week 7 through Week 23)|All randomized participants who began withdrawal of background AED (Visit 5) minus any major protocol violators||percentage of participants|||Number
725713|NCT00355082|Secondary|Time to Discontinuation in the Treatment Phase|Time (days) until the participant discontinued the study|From Study Visit 5 through Visit 9 of the Treatment phase (approximately Week 7 through Week 23)|Intent-to-Treat (ITT) Population: All participants who were randomized and began dosing with study drug||Days||Standard Deviation|Mean
725714|NCT00355082|Secondary|The Percentage of Participants in the 250 mg/Day Dose Group Who Prematurely Discontinued the Study Between Study Visit 5 (Approximately Week 7) and Visit 9 (End of the Treatment Phase)|The percentage of participants prematurely discontinuing the study was calculated as the number of participants who discontinued the study divided by the number who had reached Visit 5 minus major protocol violators. The Control group was composed of data from other similar studies and is not part of this study.|From Study Visit 5 through Visit 9 of the Treatment phase (approximately Week 7 through Week 23)|All randomized participants in the 250 mg/day dose group who began withdrawal of background AED (Visit 5) minus any major protocol violators||percentage of participants|||Number
725755|NCT00355394|Secondary|The Number of Subjects With a NRS Score of Zero at One Hour.|The NRS is a 0 to 10 point scale with 0 representing no headache and 10 representing severe headache.|1 hour|All participants included.||participants|||Number
725756|NCT00355394|Primary|The Number of Subjects With a Numeric Rating Scale Score (NRS) of Zero at Two Hours.|The NRS is a 0 to 10 point scale with 0 representing no headache and 10 representing severe headache.|2 hours|All participants included.||participants|||Number
725715|NCT00355082|Primary|The Percentage of Participants in the 300 mg/Day Dose Group Who Prematurely Discontinued the Study Between Study Visit 5 (Approximately Week 7) and Visit 9 (End of the Treatment Phase)|The percentage of participants prematurely discontinuing the study was calculated as the number of participants who discontinued the study divided by the number who reached Visit 5 minus major protocol violators. The Control group is composed of data from other similar studies and is not part of this study.|From Study Visit 5 through Visit 9 of the Treatment Phase (approximately Week 7 through Week 23)|All randomized participants in the 300 mg/day dose group who began withdrawal of background antiepileptic drug (AED) (Visit 5) minus any major protocol violators||percentage of participants|||Number
725724|NCT00355134|Secondary|Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Z-score|The Multiple Sclerosis Functional Composite (MSFC) is a multidimensional clinical outcome measure that includes quantitative tests of leg function/ambulation (Timed 25-Foot Walk), arm function (9-Hole Peg Test), and cognitive function (Paced Auditory Serial Addition Test). The overall MSFC z-score as an average of the three standardized scores derived using baseline data pooled over each treatment arm as reference population. Higher scores reflect better neurological function and a positive change from Baseline indicates improvement.|Baseline, Month 24 and end of study (up to approximately 54 months)|"Core intent-to-treat (ITT) population: All patients who were randomized in the Core phase and received at least one dose of Core phase drug. N indicates the number of participants with non-missing data at each time point."||units on a scale||Standard Deviation|Mean
725725|NCT00355134|Secondary|Percentage of Participants Relapse-free up to End of Study|Estimates of the percentage of participants relapse-free at end of study were generated from Kaplan-Meier curves of the time to first relapse. A relapse was defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The abnormality must be present for at least 24 hours and occur in the absence of fever (<37.5C) or infection. A relapse was confirmed by an Independent Evaluating Physician.|From Baseline until the end of study (up to approximately 54 months)|Core intent-to-treat (ITT) population: All patients who were randomized in the Core phase and received at least one dose of Core phase drug.||percentage of participants||95% Confidence Interval|Number
725726|NCT00355134|Secondary|Percentage of Participants Relapse-free up to Month 24|Estimates of the percentage of participants relapse-free at 24 months were generated from Kaplan-Meier curves of the time to first relapse. A relapse was defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The abnormality must be present for at least 24 hours and occur in the absence of fever (<37.5C) or infection. A relapse was confirmed by an Independent Evaluating Physician.|24 months|Full analysis set||percentage of participants||95% Confidence Interval|Number
725996|NCT00358826|Primary|Change From Baseline on ex Vivo Leukotriene B4 Synthesis in Whole Blood||Baseline and 12 weeks|Core Study Evaluable Population||pg/mL||95% Confidence Interval|Least Squares Mean
725727|NCT00355134|Secondary|Percentage of Participants Free of 6-month Confirmed Disability Progression at Month 24 and End of Study|Disability progression was defined using the following criteria: One point increase from baseline in patients with Baseline Expanded Disability Status Scale (EDSS) score from 0 to 5.0; or half a point increase from Baseline in patients with Baseline EDSS score of 5.5 or above. A 6-month confirmed disability progression was defined as a 6-month sustained increase from Baseline in EDSS score. The EDSS quantifies disability in multiple sclerosis in 8 functional systems; the score ranges from 0 (normal) to 10 (death due to MS). Progression curves were generated by the Kaplan-Meier method.|24 months and end of study (up to approximately 54 months)|Core intent-to-treat (ITT) population: All patients who were randomized in the Core phase and received at least one dose of Core phase drug.||percentage of participants||95% Confidence Interval|Number
725728|NCT00355134|Secondary|Percentage of Participants Free of 3-month Confirmed Disability Progression at Month 24 and End of Study|Disability progression was defined using the following criteria: One point increase from baseline in patients with Baseline Expanded Disability Status Scale (EDSS) score from 0 to 5.0; or half a point increase from Baseline in patients with Baseline EDSS score of 5.5 or above. A 3-month confirmed disability progression was defined as a 3-month sustained increase from Baseline in EDSS score. The EDSS quantifies disability in multiple sclerosis in 8 functional systems; the score ranges from 0 (normal) to 10 (death due to MS). Progression curves were generated by the Kaplan–Meier method.|24 months and end of study (up to approximately 54 months)|Core intent-to-treat (ITT) population: All patients who were randomized in the Core phase and received at least one dose of Core phase drug.||percentage of participants||95% Confidence Interval|Number
725729|NCT00355134|Secondary|Change From Baseline in Lesion Volume at Month 24 (Core Phase)|Change from Baseline in lesion volume was measured by MRI for T2 lesions and for T1 hypointense lesions.|Baseline and Month 24|Full analysis set for whom data were available. N=the number of patients with non-missing baseline and post-baseline values.||mm^3||Standard Deviation|Mean
725730|NCT00355134|Secondary|Number of Gadolinium-enhanced T1 Lesions|Inflammatory disease activity was assessed by magnetic resonance imaging (MRI) measurement of the number of gadolinium-enhanced T1 lesions.|Month 24 and end of study (up to approximately 54 months)|"Core intent-to-treat (ITT) population: All patients who were randomized in the Core phase and received at least one dose of Core phase drug. N indicates the number of participants with evaluable MRI data for the specified time point."||lesions||Standard Deviation|Mean
725731|NCT00355134|Secondary|Number of New or Newly Enlarged T2 Lesions|Inflammatory disease activity was assessed by magnetic resonance imaging (MRI) measurement of the number of new or newly enlarged T2 lesions, by year.|From Baseline until Month 48|"Core intent-to-treat (ITT) population: All patients who were randomized in the Core phase and received at least one dose of Core phase drug. Patients were grouped according to the assigned treatment. N indicates the number of participants with MRI data available for the specified time period."||lesions||Standard Deviation|Mean
725732|NCT00355134|Secondary|Percent Change From Baseline in Brain Volume|Brain volume was measured using magnetic resonance imaging (MRI). Change from Baseline in brain volume is expressed as a percentage of the Baseline brain volume.|Baseline, Month 24 and end of study (up to approximately 54 months)|"Core intent-to-treat (ITT) population: All patients who were randomized in the Core phase and received at least one dose of Core phase drug. Patients were grouped according to the assigned treatment. N indicates the number of participants with data available for the specified time period."||percent change||Standard Deviation|Mean
725733|NCT00355134|Secondary|Aggregate Annualized Relapse Rate (ARR) Estimate up to End of Study|"ARR is the average number of relapses in a year calculated by negative binomial regression as the sum of confirmed relapses of all patients in the group divided by the sum of the number of days on study of all patients in the group and multiplied by 365.25.
A relapse was defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The abnormality must be present for at least 24 hours and occur in the absence of fever (<37.5C) or known infection. A relapse must be confirmed by the Independent Evaluating Physician (examining neurologist).
ARR estimates were calculated from a negative binomial regression model adjusted for treatment, pooled center, number of relapses in the previous 2 years prior to enrollment, and Baseline expanded disability status scale (EDSS)."|From Baseline until end of study (up to approximately 54 months).|Core intent-to-treat (ITT) population: All patients who were randomized in the Core phase and received at least one dose of Core phase drug.||relapses per year||95% Confidence Interval|Number
725734|NCT00355134|Primary|Aggregate Annualized Relapse Rate (ARR) Estimate up to Month 24|"ARR is the average number of relapses in a year calculated by negative binomial regression as the sum of confirmed relapses of all patients in the group divided by the sum of the number of days on study of all patients in the group and multiplied by 365.25.
A relapse was defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The abnormality must be present for at least 24 hours and occur in the absence of fever (<37.5C) or known infection. A relapse must be confirmed by the Independent Evaluating Physician (examining neurologist).
ARR estimates were calculated from a negative binomial regression model adjusted for treatment, pooled center, number of relapses in the previous 2 years prior to enrollment, and Baseline expanded disability status scale (EDSS)."|24 months|Full analysis set, including all patients who were randomized and took at least one dose of study drug.||relapses per year||95% Confidence Interval|Number
725735|NCT00355147|Secondary|Medication (Hypertension) Compliance for Secondary Stroke Prevention Risk Factor Management|"Medication Possession Ratios 6 months post stroke event based upon Pharmacy Refill data
Medication Possession Ratios are the % of days in follow up period of 6 months with possession of hypertension drugs (range = 0-100%)
Compliance is defined as Medication Possession Ratio for Hypertension drugs dichotomized as greater than and equal to 80%."|Baseline, 6 months|We hypothesized the intervention group would report significantly greater medication compliance than the control group. The level of significance was set to 0.05. The number of participants were set per protocol and we used intention to treat in our protocol and analyses.||participants|||Number
725757|NCT00355472|Secondary|Time to Progression (TTP)|TTP was defined as the period from the day starting the first KW-0761 dosing to the day of PD identification (or the day of death if the subject died before PD was documented). Subjects were to be censored at the time of starting post-treatment, if it was started before PD identification.|Baseline to response|||days||Full Range|Median
725736|NCT00355147|Secondary|Medication (Statins) for Secondary Stroke Prevention Risk Factor Management|"Medication Possession Ratios 6 months post stroke event based upon Pharmacy Refill data
Medication Possession Ratios are the % of days in follow up period of 6 months with possession of Statin drugs (range= 0-100%).
Compliance is defined as Medication Possession Ratio for Statin drugs dichotomized as greater than and equal to 80%."|baseline, 6 months|We hypothesized the intervention group would report significantly greater medication compliance than the control group. The level of significance was set to 0.05. The number of participants were set per protocol and we used intention to treat in our protocol and analyses.||participants|||Number
725737|NCT00355147|Secondary|Medication (Diabetes) Compliance for Secondary Stroke Prevention Risk Factor Managment|"Medication Possession Ratios 6 months post stroke events based upon Pharmacy Refill data
Medication Possession Ratios are the % of days in follow up period of 6 months with possession of oral Diabetes drugs (range = 0 -100%)
Compliance is defined as Medication Possession Ratio for Diabetes drugs dichotomized as greater than and equal to 80%"|baseline, 6 months|We hypothesized the intervention group would report significantly greater medication compliance than the control group. The level of significance was set to 0.05. The number of participants were set per protocol and we used intention to treat in our protocol and analyses.||participants|||Number
725738|NCT00355147|Primary|Self-Efficacy to Manage Stroke Symptoms|Confidence to manage symptoms and health post stroke on a 1-10 scale where 10 denotes a lot of confidence and a 1 denotes no confidence.|6 months|We hypothesized the intervention group would report significantly greater self-efficacy to manage stroke symptoms than the control group. Level of significance was set to .05. Number of participants were set per protocol and we used intention to treat in our protocol and analyses. We adjusted the analyses for group, TIA/Stroke, site, & time.||units on a scale||Standard Deviation|Mean
725739|NCT00355147|Primary|Stroke Specific Health Related Quality of Life|"Stroke Specifc, Health Related Quality of Life (SSQoL)
Self reported survey by LS Williams Weinberger M, Clark, D, Harris L, Biller J. Development of a stroke specific quality of life scale. Stroke, 1999;30:1362-1369.
Contains 12 domains and 49 items Scored on a 5 pt Likert response format with lower score indicating worse function/lower ability on that item or domain. Domain scores were calculated as an unweighted average of item scores in that domain. Overall Total Score was calculated as an unweighted average of domain scores.
We hypothesized the intervention group would report significantly greater stroke specific quality of life than the control group. The level of significance was set to 0.05."|6 months for (SSQoL) and 3 months for Perceived Energy Subdomain|We hypothesized the intervention group would report significantly greater stroke specific quality of life than the control group. The level of significance was set to 0.05. Number of participants were set per protocol and we used intention to treat in our protocol and analyses. We adjusted the analyses for group, TIA/Stroke, site, and time.||units on a scale||Standard Deviation|Mean
725740|NCT00355199|Secondary|Efficacy of R-HDS Conditioning as Salvage Therapy in Patients Non-responders After Four Cycles of R-CHOP 14||Through completion of salvage therapy||||||
725741|NCT00355199|Secondary|Toxicity|Percentage of participants with at least one reported episode of CTC grade III or IV toxic events|Through therapy completion an average of 8 months|||percentage of participants|||Number
725742|NCT00355199|Secondary|Overall Survival|OS was defined from the time of the study entry to death as a result of any cause or date of the last follow-up visit|36 months from end of therapy|||percentage of OS at 3 years follow-up||95% Confidence Interval|Number
725743|NCT00355199|Secondary|Disease Free Survival|DFS was defined from the time of documentation of CR to time to relapse or death as a result of lymphoma or acute toxicity of treatment or date of the last follow-up visit|36 months from end of therapy|||percentage of DFS at 3 years follow-up||95% Confidence Interval|Number
725744|NCT00355199|Secondary|Complete Remission|Clinical response was assessed by complete restaging according to Cheson criteria. Cheson BD, Pfistner B, Juweid ME, et al: Revised response criteria for malignant lymphoma. J Clin Oncol 25:579-86, 2007|Through therapy completion an average of 8 months|||participants|||Number
725745|NCT00355199|Primary|Event Free Survival|EFS was defined from the time of the study entry to any treatment failure including disease progression or discontinuation of treatment for any reason or date of the last follow-up visit|36 months from end of therapy|||percentage of EFS at 3 years follow-up||95% Confidence Interval|Number
725746|NCT00355368|Secondary|Number of Participants With an Failed First Intubation Attempts|defined as either uncompleted intubation attempt within 90 sec or starting a second intubation attempt|within the first 90 sec following the start of induction|||participants|||Number
725747|NCT00355368|Secondary|Quality of Intubation Conditions Using a Validated Score: Viby-Mogensen et al. Good Clinical Research Practice (GCRP) in Pharmacodynamic Studies of Neuromuscular Blocking Agents. Acta Anaesthesiol Scand 1996;40:59-74.|"The factors laryngoscopy, vocal cords, and response to intubation are individually rated with a score from 1 (bad intubation conditions)to 3 (excellent intubation conditions)and the resulting three scores are summed up. The maximum score is thus 9 while the minimum score is 3.
Units: measure on a scale"|during laryngoscopy and the first minute after completion of intubation|||score points||Standard Deviation|Mean
725748|NCT00355368|Secondary|Time to Completion of Intubation|time interval between the injection of the induction agent and the first appearance of endtidal CO2|time interval between the injection of the induction agent and the first appearance of endtidal CO2|||seconds||Standard Deviation|Mean
725749|NCT00355368|Secondary|Haemodynamic Sequelae of Intubation|any new haemodynamic alteration requiring immediate intervention|between start of induction sequence and 5 min after completion of intubation||||||
725750|NCT00355368|Primary|Number of Participants Exhibiting Desaturation >5%|decrease of >5% in oxygen saturation measured continuously using pulse oxymetry|at any time between the start of the intubation sequence and 2min after the completion of intubation|ITT||participants|||Number
725751|NCT00355394|Secondary|Change in Headache Intensity as Measured by the NRS Score From Baseline to the 24 Hour Assessment.|The NRS is a 0 to 10 point scale with 0 representing no headache and 10 representing severe headache.|24 hours|||NRS Score||Standard Deviation|Mean
725752|NCT00355394|Secondary|Change in Headache Intensity as Measured by the NRS Score From Baseline to the Two Hour Assessment.|The NRS is a 0 to 10 point scale with 0 representing no headache and 10 representing severe headache.|2 hours|||NRS Score||Standard Deviation|Median
727603|NCT00377312|Secondary|Serum Amino-terminal of Collagen- (sNTX)|% change from baseline|baseline, daily, one week follow-up|||% change from baseline||Standard Error|Mean
725758|NCT00355472|Primary|Pharmacokinetics-Pharmacokinetic Parameters of KW-0761 (t1/2)|The pharmacokinetic parameters of the subjects were to be individually calculated, and their descriptive statistics were to be calculated on a dose-by-dose basis.|0 to 28 days post final dose and follow-up examinations (1 month and 2 months after the end of the post-dosing observation period).|t1/2||hours||Standard Deviation|Mean
725759|NCT00355472|Primary|Pharmacokinetics-Pharmacokinetic Parameters of KW-0761 (AUC0-7 Days)|The pharmacokinetic parameters of the subjects were to be individually calculated, and their descriptive statistics were to be calculated on a dose-by-dose basis.|0-7 days post final dose|AUC0-7 days||ng·h/mL||Standard Deviation|Mean
725760|NCT00355472|Primary|Pharmacokinetics-Plasma KW-0761 Concentrations|Plasma KW-0761 concentrations were to be summarized in tabular form with the descriptive statistics on a dose-by-dose basis. Individual and mean (+ standard deviation) plasma KW-0761 concentrations on an actual or logarithmic scale were to be plotted against the time of blood sampling.|0-7 days post final dose|||ng/mL||Standard Deviation|Mean
725761|NCT00355472|Secondary|Antitumor Effect|The antitumor response criteria (Complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD)) were created based on the criteria for non-Hodgkin's lymphoma and chronic lymphocytic leukemia provided in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology as well as the criteria for non-Hodgkin's lymphoma by the Lymphoma Study Group of the Japan Clinical Oncology Group (JCOG-LSG).|50 days|||participants|||Number
725762|NCT00355472|Primary|Maximum Tolerated Dose (MTD)|The dose level at which Dose-Limiting Toxicity (DLT) was recognized was to be regarded as Maximum Tolerated Dose (MTD), and the dose level below MTD by one level was to be regarded as the recommended dose level (when MTD was not reached, 1.0 mg/kg was to be regarded as the recommended dose level) and 3 more subjects were to be newly added to the recommended dose level.|28 days|||mg/kg|||Number
725763|NCT00355472|Primary|Incidence of Dose-Limiting Toxicities (DLTs)|Subjects who were properly monitored for DLTs were to be analyzed to determine the number of subjects with a DLT by dose level.|28 days|||participants|||Number
725764|NCT00355615|Secondary|Percent Change in Non-HDL-C/HDL-C|Percent change in the ratio of non-HDL-C/HDL-C after 12 weeks of treatment|After 12 weeks of treatment|Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables.||mean percent change||Standard Deviation|Mean
725765|NCT00355615|Secondary|Percent Change in TC/HDL-C|Percent change in the ratio of TC/HDL-C after 12 weeks of treatment|After 12 weeks of treatment|Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables.||mean percent change||Standard Deviation|Mean
725766|NCT00355615|Secondary|Percent Change in LDL-C/HDL-C|Percent change in the ratio of LDL-C/HDL-C after 12 weeks of treatment|After 12 week of treatment|Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables.||mean percent change||Standard Deviation|Mean
725767|NCT00355615|Secondary|Percent Change in ApoB/ApoA-1|Percent change in the ratio of ApoB/ApoA-1 after 12 weeks of treatment|After 12 weeks of treatment|Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables.||mean percent change||Standard Deviation|Mean
725768|NCT00355615|Secondary|Percent Change in Apolipoprotein B (ApoB)|Percent change in ApoB after 12 weeks of treatment|After 12 weeks of treatment|Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables.||mean percent change||Standard Deviation|Mean
725769|NCT00355615|Secondary|Percent Change in Apolipoprotein A-1 (ApoA-1)|Percent change in ApoA-1 after 12 weeks of treatment|After 12 weeks of treatment|Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables.||mean percent change||Standard Deviation|Mean
725770|NCT00355615|Secondary|Percent Change in Total Cholesterol (TC)|Percent change from baseline in total cholesteral after 12 weeks of treatment|After 12 weeks of treatment|Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables.||percent change||Standard Deviation|Mean
725771|NCT00355615|Secondary|Percent Change in Triglycerides (TG)|Percent change in tryglycerides (TG) after 12 weeks of treatment|After 12 weeks of treatment|Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables.||percent change||Standard Deviation|Mean
725772|NCT00355615|Secondary|Percent Change in Non-HDL-C at 12 Weeks|Percent change in non-HDL-C at 12 weeks|After 12 weeks of treatment|Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables.||percent change||Standard Deviation|Mean
725893|NCT00356590|Primary|Total Exposure-Adjusted Rate of Malignancies|Exposure-adjusted rate of malignancies, excluding nonmelanoma skin cancers, occurring on study within 30 days of the last dose of etanercept|Up to 8 years|All enrolled participants who received at least one dose of etanercept||Malignancies per 100 participant-years|||Number
725773|NCT00355615|Secondary|Percent Change in HDL-C|Percent change in high-density lipoprotein cholesterol (HDL-C) after 12 weeks of treatment|After 12 weeks of treatment|Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables.||percent change||Standard Deviation|Mean
725774|NCT00355615|Secondary|Percent Control Rate Based on Achievement of LDL-C Target of <110 mg/dL During Double-blind Dose Treatment|Percent of patients achieving LDL-C < 110 mg/dL out of the total patients in each treatment group|12 weeks|Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables.||Percent of Participants|||Number
725775|NCT00355615|Secondary|Percent Change in LDL-C and Other Lipid Parameters From Baseline to Week 6, and at End of Double-blind Dose Treatment Phase (Week 12)|Percent change from baseline in LDL-C after six week of treatment|6 weeks|Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables.||percentage||Standard Deviation|Mean
725776|NCT00355615|Primary|Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline (Day 0) to the End of the 12-week Double-blind Treatment Phase|Percent change in low-density lipoprotein cholesterol (LDL-C) = (final value - Baseline value)/Baseline value * 100|12 weeks|Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables.||percentage||Standard Deviation|Mean
725777|NCT00355706|Primary|Oswestry Disability Index|Oswestry Disability Index (ODI) – ODI score is ranged from 0 to 50. Total score is converted in to percent disability. ODI Scoring: 0% to 20% (minimal disability), 21%-40% (moderate disability), 41%-60% (severe disability), 61%-80% (crippled) and 81%-100 (these patients are either bed-bound or exaggerating their symptoms).|24 months|||units on a scale||Standard Deviation|Mean
725778|NCT00355706|Other Pre-specified|Opioid Intake|Opioid intake(morphine equivalence mg)|24 months|||mg/day||Standard Deviation|Mean
725779|NCT00355706|Primary|Numeric Rating Scale|Numeric rating scale represented 0 with no pain and 10 with the worst pain imaginable.|2 years|||units on a scale||Standard Deviation|Mean
725780|NCT00355784|Primary|Changes in Fat-free Mass||2 weeks|||kg||Standard Error|Mean
725781|NCT00355784|Primary|Changes in Fat Mass||2 weeks|||kg||Standard Error|Mean
725782|NCT00355784|Primary|2 Week Skeletal Muscle Protein Synthesis|after an overnight fast|2 weeks|per protocol||skeletal muscle protein%/hour||Standard Error|Mean
725783|NCT00355784|Primary|Whole Body Protein Turnover After 2 Week Intervention|whole body proteolytic rate (leucine Ra)|2 weeks|per protocol||µmol/kg fat free mass/min||Standard Error|Mean
725784|NCT00355784|Primary|Lipolytic Rate||2 weeks|per protocol||µmol/min||Standard Error|Mean
725785|NCT00355784|Primary|Baseline Skeletal Muscle Protein Synthesis|after an overnight fast|baseline|per protocol||skeletal muscle protein%/hour||Standard Error|Mean
725786|NCT00355784|Primary|Baseline Whole Body Protein Turnover|Whole body proteolytic rate (Leucine Ra)|baseline|per protocol||μmol/kg fat free mass/min)||Standard Error|Mean
725787|NCT00355784|Primary|Changes in Body Weight||2 weeks|per protocol||kg||Standard Error|Mean
725788|NCT00355784|Primary|24 Hour Average Plasma Growth Hormone Concentration||2 weeks|per protocol||ng/mL||Standard Error|Mean
725789|NCT00355797|Primary|Pulse Pressure During Activities of Daily Living Tests (Orthostatic Test)|Patients completing the orthostatic test in all three pacing modes and that had at least 80% pacing during the test in the CLS and R pacing modes are included in the analysis. The mean pulse pressure is provided.|within 45 days of enrollment|||mmHg||Standard Deviation|Mean
725790|NCT00355797|Secondary|Change in 6-minute Walk Test Distance|Change in number of 10 foot repetitions between baseline and 12-month visit were examined.|baseline and 12 months|Subjects completing the 6 minute walk at both enrollment and at the 12-month visit were included in intention to treat analysis.||repetitions||Standard Deviation|Mean
725791|NCT00355797|Secondary|Change in New York Heart Association (NYHA) Class|Number of subjects with improved, no change, or worsened NYHA classification at the 12-month visit, as compared to baseline. NYHA classifications (I to IV) are used to assess the various stages of heart failure, with Class I relating to mild heart failure and Class IV relating to severe heart failure.|baseline and 12 months|Subjects with NYHA classifications at both enrollment and at the 12-month visit were analyzed using intention to treat.||participants|||Number
725792|NCT00355797|Secondary|Cardiac Symptoms|Number of subjects exhibiting each cardiac symptom was determined at the 12 month follow-up visit.|12 months|All subjects answering questions about current cardiac symptoms at the 12-month visit were included in this intention to treat analysis.||participants|||Number
725793|NCT00355797|Secondary|Atrial Fibrillation (AF) Burden|AF burden was measured at 12 months as the percentage of total atrial beats that are at or above 160 bpm.|12 months|Percentage of atrial burden was collected for subjects utilizing dual chamber pacing that completing a 12-month follow-up visit.||percentage of atrial beats||Standard Deviation|Mean
725794|NCT00355797|Secondary|Mode Reprogramming|Number of subjects with device reprogramming from dual (atrial and ventricular pacing) to single chamber (ventricular pacing only) or from single (ventricular pacing only) to dual chamber (atrial and ventricular pacing) during the 12 month follow-up.|12 months|Subjects completing at least one follow-up visit were analyzed using intention to treat.||participants|||Number
725795|NCT00355797|Secondary|Change in Quality of Life|Change in Quality of life (QOL) score was determined from baseline to the 12 month follow-up visit. The QOL utilized the physical functioning scale of the SF-36 v2, in which a higher score indicates a better health perception. Best possible score was 57.03 while the worst possible score was 14.94.|baseline and 12 months|Subjects completing a QOL at both baseline and 12 month follow-up were included in an intention to treat analysis.||score||Standard Deviation|Mean
727604|NCT00377312|Secondary|Tubular Maximum for Phosphorous|mg/dl|baseline and daily|||mg/dl||Standard Error|Mean
725796|NCT00355797|Primary|Performance of Activities of Daily Living Tests (6-minute Walk and Sweep)|Six-minute walk test and sweep test results for subjects completing tests in all three pacing modes and requiring at least 80% pacing during both tests in the CLS and R pacing modes. The mean composite of repetitions (six minute walk plus sweep) are presented.|within 45 days of enrollment|Patients requiring at least 80% pacing during both tests in the CLS and accelerometer pacing modes are included.||repetitions||Standard Deviation|Mean
725797|NCT00355914|Primary|Oswestry Disability Index|Oswestry Disability Index 2.0 (ODI): ODI score is ranged from 0 to 50. Total score is converted in to percent disability. ODI Scoring: 0% to 20% (minimal disability), 21%-40% (moderate disability), 41%-60% (severe disability), 61%-80% (crippled) and 81%-100% (may be bed bound or exaggerating their symptoms).|Baseline, 3, 6, 12, 18, and 24 months post-treatment.|An intent-to-treat-analysis was performed on all patients utilizing the last follow-up data. Initial data were utilized in the patients who dropped out of the study without further follow-up after the first treatment.||units on a scale||Standard Deviation|Mean
725798|NCT00355914|Primary|Average Numeric Rating Scale|Numeric rating scale represented 0 with no pain and 10 with the worst pain imaginable.|Baseline, 3, 6, 12, 18, and 24 months post-treatment|||units on a scale||Standard Error|Mean
725799|NCT00356031|Secondary|Disease Free Survival|The median amount of time from the end of treatment until to distant recurrence. Distant recurrence is when cancer spreads to areas in the body away from the primary cancer site.|3 years|||Months||Full Range|Median
725800|NCT00356031|Secondary|Distant Recurrence|The number of participants with distant recurrence at the time of last follow-up. Distant recurrence is when cancer has spread (metastasized) to areas farther away from where the primary cancer site is.|3 years|||Participants|||Count of Participants
725801|NCT00356031|Secondary|Local Control Rate|The number of patients with local recurrence after a median follow-up of 24 months. Local recurrence is defined as disease progression (new cancer growth) at the primary cancer site.|3 years|||Participants|||Count of Participants
725802|NCT00356031|Secondary|Average Change in Blood Flow, Blood Volume,and Permeability Surface Area|The percentage reduction in blood flow, blood volume,and permeability surface area of the tumor following combination therapy as determined by perfusion CT (computerized tomography) scan. The percent change represents the combined average percent change for flow, volume, and permeability together.|3 years|||Percent Reduction||Full Range|Mean
725803|NCT00356031|Secondary|Change in Median Microvessel Density (MVD) After Bevacizumab Alone|The percentage change in median microvessel density (MVD) after Bevacizumab treatment alone|baseline and 3 years|||percentage of change in MVD||95% Confidence Interval|Median
725804|NCT00356031|Primary|Objective Response Rate for Neoadjuvant Bevacizumab Combined With Radiation Therapy for Intermediate and High-risk Soft Tissue Sarcomas.|The count of participants with greater than or equal to 80% pathological necrosis in the resected specimen following neoadjuvant bevacizumab and radiation.|3 years|||participants|||Number
725805|NCT00356057|Secondary|Rate of CHF Hospitalizations and Total Mortality||at six months post-procedure||||||
725806|NCT00356057|Secondary|Changes in NYHA Classification||at six months post-procedure||||||
725807|NCT00356057|Secondary|Cardiac Remodeling Assessments by Echocardiography||at six months post-procedure||||||
725808|NCT00356057|Secondary|Improvement in QOL Score||at six months post-procedure||||||
725809|NCT00356057|Secondary|Improvement in 6-minute Walk Test||at six months post-procedure||||||
725810|NCT00356057|Primary|System-related Complication-free Rate||at six months post-procedure||||||
725811|NCT00356057|Primary|Average Percentage Improvement From Baseline of the 6-minute Walk Test Distance and Minnesota Living With Heart Failure Quality of Life Score at 6-months|Combined, average percentage improvement in 6-minute walk test distance and Minnessota Living With Heart Failure Quality of Life score from baseline to 6-month follow-up for the Protos DR/CLS (Group 1) and Stratos LV (Group 2) compared with the active control (Group 3). The 6-minute walk test is a test that measure how far a patient can walk in 6 minutes in a standardized walking course. Percent Change (0% (worst)-100% (best))|Change from baseline to six months post-procedure|Patients included in this analysis are those patients with complete six minute walk test and Quality of Life data at both baseline and the six-month follow-up.||Percent Change||Standard Error|Mean
725812|NCT00356122|Secondary|Number of Participants With Treatment-related Toxicities|"Treatment-related toxicities were serious and non-serious adverse events (AE) considered related to study treatment by the investigator.
AEs were any unfavorable and unintended signs, symptoms, syndromes, or illnesses that developed or worsened during the observation period, and included abnormal results from diagnostic procedures. Serious AEs resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability or incapacity, appeared as a congenital anomaly or were considered medically important by the investigator."|From baseline up to 30 days after treatment discontinuation|All participants who received at least one dose of study treatment||Participants|||Number
725813|NCT00356122|Secondary|Overall Survival (OS)|OS was measured from the date of registration to the date of death due to any cause, or to the date of last contact (for censored observations). OS was assessed by the Kaplan-Meier method and the estimates of median survival time with 95% CI are reported.|Baseline to OS (up to 24 months after the first treatment)|All participants registered to receive study treatment||Months||95% Confidence Interval|Median
725814|NCT00356122|Secondary|Time-to-treatment Failure (TTF)|"Treatment failure was defined as an event which lead to the participant’s withdrawal from the study treatment due to lack of efficacy, disease progression, adverse events, or due to a participant's request as recorded in the Case Report Form (CRF), death, or use of other anticancer therapy.
TTF was assessed using Kaplan-Meier method, and the median TTF with 95% CIs was computed using the Brookmeyer and Crowley method."|Baseline to treatment failure (up to 24 months after the first treatment)|All participants registered to receive study treatment||Months||95% Confidence Interval|Median
725841|NCT00356408|Secondary|Disease Remission (Crohn's Disease Activity Index, CDAI≤150) at Week 34 in Patients Who Completed/Did Not Complete C87059 (COSPAR I, NCT00349752) and Remained Off Corticosteroids.|Crohn’s disease activity index (CDAI) is used to quantify the symptoms of Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. Results are presented as the percentage of subjects in disease remission at Week 34.|Week 34 in this study|All subjects in the the Intent to Treat (ITT) population are included in this analysis.||percentage of subjects|||Number
725815|NCT00356122|Secondary|Objective Response Rate|"Objective response rate is the percentage of participants with an objective response. Improvements in tumor measurements from baseline values were assigned a status of Complete Response (CR) or Partial response (PR) based on the Response Evaluation Criteria in Solid Tumors (RECIST). Overall objective response was the sum of CR and PR.
CR referred to the disappearance of all target lesions, and PR was at least 30% decrease in the sum of the longest diameter (LD) of target lesions, compared to the baseline sum LD. Responses were confirmed by repeat assessments within 4 to 6 weeks."|Baseline to CR or PR (up to 24 months after the first treatment)|All participants registered to receive study treatment||Percentage of participants||95% Confidence Interval|Mean
725816|NCT00356122|Primary|Progression-free Survival (PFS)|"PFS was defined as the interval from the date of registration to the earliest date of documented evidence of progressive disease, or the date of death due to any cause, whichever occurred first.
Progressive disease occurred when the participant had at least a 20% increase in the sum of the longest diameter (LD) of target lesions, compared to the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions."|Baseline to PFS (up to 24 months after the first treatment)|All participants registered to receive study treatment||Months||95% Confidence Interval|Median
725817|NCT00356135|Secondary|Number of Participants With Bleeding Events by Visit According to Thrombolysis in Myocardial Infarction Study Group (TIMI) Criteria|Bleeding events were classified as Major Bleeding, Minor Bleeding, or Insignificant according to TIMI criteria. Major Bleeding: any intracranial hemorrhage OR any clinically overt bleeding (including bleeding evident on imaging studies) associated with a fall in hemoglobin (Hgb) of ≥5 gm/dL from baseline. Minor Bleeding: any clinically overt bleeding (including bleeding evident on imaging studies) associated with a fall in Hgb of ≥3 gm/dL but <5 gm/dL from baseline. Insignificant Bleeding: any bleeding event that does not meet criteria for a Major or Minor Bleed.|End of 14 day open label (baseline); 24 Hours, 7 days, 14 days after first dose of randomized drug|Safety Population - all randomized participants.||Participants|||Number
725818|NCT00356135|Secondary|Correlation Coefficent of Verify Now™ P2Y12 Assay Values to Maximum Platelet Aggregation (MPA) and Residual Platelet Aggregation (RPA) to 20 uM ADP at 1 Week|Correlation Coefficient comparing the Accumetrics VerifyNow™ P2Y12 device with light transmittance aggregometry (LTA) for monitoring platelet aggregation.|1 week after randomized study drug|Pharmacodynamic Population, which included all randomized participants who had blood draws for MPA, who met compliance criteria, and who had last dose of study drug the day prior to the blood draw for MPA.||correlation coefficient|||Number
725819|NCT00356135|Secondary|Residual Platelet Aggregation (RPA) (to 5 and 20 uM ADP) at 2 Hours, 24 Hours, 1 Week and 2 Weeks|Residual platelet aggregation after the addition 5 and 20 micromolar ADP as measured with light transmittance aggregometry (LTA).|2 hours, 24 hours, 1 week, 2 weeks after first dose of randomized study drug|Pharmacodynamic Population, which included all randomized participants who had blood draws for MPA, who met compliance criteria, and who had last dose of study drug the day prior to the blood draw for MPA.||percent residual platelet aggregation||Standard Deviation|Mean
725820|NCT00356135|Secondary|Maximum Platelet Aggregation (MPA) to 20 uM ADP According to Clopidogrel Use at Time of Qualifying Acute Coronary Syndrome (ACS) Event|Data provided are the MPA to 20 micromolar ADP while taking clopidogrel (measurement taken at end of the 14 day open label phase) grouped by subjects who were taking clopidogrel at the time of the qualifying ACS event compared with subjects who were not taking clopidogrel at the time of the qualifying ACS event.|End of 14 day open label|Pharmacodynamic Population, which included all randomized participants who had blood draws for MPA, who met compliance criteria, and who had last dose of study drug the day prior to the blood draw for MPA. Grouped according to clopidogrel use at time of ACS event and no clopidogrel use at time of ACS event.||percent maximum platelet aggregation (%)||Standard Deviation|Mean
725821|NCT00356135|Secondary|Maximum Platelet Aggregation (MPA) (to 5 and 20 uM ADP) at 2 Hours, 24 Hours, 1 Week and 2 Weeks|Maximum platelet aggregation (MPA) to 5 and 20 micromolar adenosine diphosphase (ADP) as measured with light transmittance aggregometry (LTA).|2 hours, 24 hours, 1 week, 2 weeks after first dose of randomized study drug|Pharmacodynamic Population, which included all randomized participants who had blood draws for MPA, who met compliance criteria, and who had last dose of study drug the day prior to the blood draw for MPA.||percent maximum platelet aggregation (%)||Standard Deviation|Mean
725822|NCT00356135|Primary|Maximum Platelet Aggregation (MPA) to 20 Micromolar (uM) Adenosine Diphosphase (ADP)|Maximum platelet aggregation (MPA) to 20 micromolar adenosine diphosphase (ADP) as measured with light transmittance aggregometry (LTA).|1 week after first dose of randomized study drug|The primary analysis population was the pharmacodynamic (PD) population which included all randomized participants who had blood draws for MPA at 1 week after randomization who met compliance criteria, and who had last dose of study drug the day prior to the blood draw for MPA.||percent maximum platelet aggregation (%)||Standard Error|Least Squares Mean
725823|NCT00356148|Secondary|Overall SSI-related Prophylaxis and Treatment Cost in Patients With BMI Over 25 Who Received Prophylaxis (Prophylaxis Group) and Not (No Prophylaxis Group).||1 month|||Monetary unit in Turkish Liras||Standard Error|Mean
725824|NCT00356148|Primary|Number of Patients With Body Mass Index (BMI) Over 25 Who Developed Surgical Site Infection (SSI) in Groups Who Received Antibiotic Prophylaxis (Prophylaxis Group) and no Prophylaxis (No Prophylaxis Group).||1 month|Analysis was intent-to-treat||participants|||Number
725825|NCT00356200|Primary|Change in Target Lesion Score at Week 4 Compared to Baseline|Change in score from 0-14 of target lesion disease activity based on scaling, erythema, and induration as determined by a physician assessor at week 4 compared to baseline (with 0 being no disease activity and 14 being maximum disease activity).|Baseline to week 4|all 5 patients per cohort completed the visit at week 4||units on a scale||Standard Deviation|Mean
725826|NCT00356200|Secondary|Change in Target Lesion Pruritus Visual Analog Scale (VAS) at Week 4 Compared to Baseline.|Target lesion pruritus as measured by the Visual Analog Scale (VAS) from 0 to 100 mm at week 4 compared to baseline (with 0 being no pruritis and 100 being maximum pruritis).|Baseline to week 4|all 5 patients per cohort completed the visit at week 4||mm||Standard Deviation|Mean
725842|NCT00356408|Primary|Occurrence of at Least One Treatment-emergent Adverse Event During This Study (Maximum 122 Weeks)|Results are presented as the number of subjects with at least one treatment-emergent adverse event during this study.|During this study (maximum 122 weeks)|All subjects in the the Intent to Treat (ITT) population are included in this analysis.||subjects|||Number
725827|NCT00356278|Secondary|PTSD Symptom Scale Self-Report|PTSD Symptom Scale – Self-Report Version (PSS-SR) is a 17-item self-reported questionnaire to assess symptoms of PTSD. Each of the 17 items describe PTSD symptoms which respondents rate in terms of their frequency or severity using a Likert-type scale ranging from 0 (not at all or only one time) to 3 (almost always or five or more times per week). Ratings on items are summed to create three subscales, including re-experiencing, avoidance, and arousal, as well as a total score (that ranges from 0 to 51). The total score higher than 13 indicates on likelihood of PTSD.|Month 12|Intent to Treat Analyses using all available information with Full Information Maximum Likelihood Estimation (FIML)to handle missing data||units on a scale||95% Confidence Interval|Mean
725828|NCT00356278|Secondary|PTSD Symptom Scale Self-Report|PTSD Symptom Scale – Self-Report Version (PSS-SR) is a 17-item self-reported questionnaire to assess symptoms of PTSD. Each of the 17 items describe PTSD symptoms which respondents rate in terms of their frequency or severity using a Likert-type scale ranging from 0 (not at all or only one time) to 3 (almost always or five or more times per week). Ratings on items are summed to create three subscales, including re-experiencing, avoidance, and arousal, as well as a total score (that ranges from 0 to 51). The total score higher than 13 indicates on likelihood of PTSD.|Month 6|Intent to Treat Analyses using all available information with Full Information Maximum Likelihood Estimation (FIML)to handle missing data||units on a scale||95% Confidence Interval|Mean
725829|NCT00356278|Secondary|PTSD Symptom Scale Self-Report|PTSD Symptom Scale – Self-Report Version (PSS-SR) is a 17-item self-reported questionnaire to assess symptoms of PTSD. Each of the 17 items describe PTSD symptoms which respondents rate in terms of their frequency or severity using a Likert-type scale ranging from 0 (not at all or only one time) to 3 (almost always or five or more times per week). Ratings on items are summed to create three subscales, including re-experiencing, avoidance, and arousal, as well as a total score (that ranges from 0 to 51). The total score higher than 13 indicates on likelihood of PTSD.|Month 3|Intent to Treat Analyses using all available information with Full Information Maximum Likelihood Estimation (FIML)to handle missing data||units on a scale||95% Confidence Interval|Mean
725830|NCT00356278|Secondary|PTSD Symptom Scale Self-Report|PTSD Symptom Scale – Self-Report Version (PSS-SR) is a 17-item self-reported questionnaire to assess symptoms of PTSD. Each of the 17 items describe PTSD symptoms which respondents rate in terms of their frequency or severity using a Likert-type scale ranging from 0 (not at all or only one time) to 3 (almost always or five or more times per week). Ratings on items are summed to create three subscales, including re-experiencing, avoidance, and arousal, as well as a total score (that ranges from 0 to 51). The total score higher than 13 indicates on likelihood of PTSD.|Posttreatment, 8 weeks|Intent to Treat Analyses using all available information with Full Information Maximum Likelihood Estimation (FIML)to handle missing data||units on a scale||95% Confidence Interval|Mean
725831|NCT00356278|Primary|Clinician-Administered PTSD Scale (CAPS)|Scores may range from 0 (no symptoms) to 136 (severe symptoms). The score is based on the first 17 CAPS items administered.|Month 12|Intent to Treat Analyses using all available information with Full Information Maximum Likelihood Estimation (FIML)to handle missing data||units on a scale||95% Confidence Interval|Mean
725832|NCT00356278|Primary|Clinician-Administered PTSD Scale (CAPS)|Scores may range from 0 (no symptoms) to 136 (severe symptoms). The score is based on the first 17 CAPS items administered.|Month 6|Intent to Treat Analyses using all available information with Full Information Maximum Likelihood Estimation (FIML)to handle missing data||units on a scale||95% Confidence Interval|Mean
725833|NCT00356278|Primary|Clinician-Administered PTSD Scale (CAPS)|Scores may range from 0 (no symptoms) to 136 (severe symptoms). The score is based on the first 17 CAPS items administered.|Month 3|Intent to Treat Analyses using all available information with Full Information Maximum Likelihood Estimation (FIML)to handle missing data||units on a scale||95% Confidence Interval|Mean
725834|NCT00356278|Primary|Clinician-Administered PTSD Scale (CAPS)|Scores may range from 0 (no symptoms) to 136 (severe symptoms). The score is based on the first 17 CAPS items administered.|Posttreatment, 8 weeks|Intent to Treat Analyses using all available information with Full Information Maximum Likelihood Estimation (FIML)to handle missing data||units on a scale||95% Confidence Interval|Mean
725835|NCT00356278|Secondary|PTSD Symptom Scale Self-Report|PTSD Symptom Scale – Self-Report Version (PSS-SR) is a 17-item self-reported questionnaire to assess symptoms of PTSD. Each of the 17 items describe PTSD symptoms which respondents rate in terms of their frequency or severity using a Likert-type scale ranging from 0 (not at all or only one time) to 3 (almost always or five or more times per week). Ratings on items are summed to create three subscales, including re-experiencing, avoidance, and arousal, as well as a total score (that ranges from 0 to 51). The total score higher than 13 indicates on likelihood of PTSD.|Baseline|Intent to Treat Analyses using all available information with Full Information Maximum Likelihood Estimation (FIML)to handle missing data||units on a scale||95% Confidence Interval|Mean
725836|NCT00356278|Primary|Clinician-Administered PTSD Scale (CAPS)|Scores may range from 0 (no symptoms) to 136 (severe symptoms). The score is based on the first 17 CAPS items administered.|Baseline|Intent to Treat Analyses using all available information with Full Information Maximum Likelihood Estimation (FIML)to handle missing data||units on a scale||95% Confidence Interval|Mean
725837|NCT00356304|Secondary|Medication Attitudes||Measured at Month 5||||||
725838|NCT00356304|Secondary|Beck Depression Inventory-II (BDI-II)|"The BDI-II contains 21 questions, each answer being scored on a scale value of 0 to 3.
0–13: minimal depression; 14–19: mild depression; 20–28: moderate depression; and 29–63: severe depression. Higher total scores indicate more severe depressive symptoms."|Measured at Month 5|||units on a scale||Standard Error|Mean
725839|NCT00356304|Secondary|Treatment Retention||Measured at Month 5||||||
725840|NCT00356304|Primary|Medication Adherence, as Measured by Electronic Pill Container|Medication container caps (MEMS) recorded each instance where the antidepressant medication container was opened. An adherence index was derived the represented the percentage of days, within the medication period, where the container was opened.|Measured immediately post-treatment and at Months 2 and 5 months follow-ups|We used an ITT with LOCF. These figures represent outcomes at 5 months.||Percentage of Days||Standard Error|Mean
725891|NCT00356590|Primary|Total Exposure Adjusted Rate of Serious Infectious Events|Exposure-adjusted rate of serious infectious events (associated with hospitalization or IV antibiotics) occurring on study within 30 days of the last dose of etanercept|Up to 8 years|All enrolled participants who received at least one dose of etanercept||Events per 100 participant-years|||Number
725843|NCT00356421|Other Pre-specified|Subject Reported Quality of Life From Baseline as Determined From Phase V System Measurement|As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.|At weeks 6, 24, and 52 or last observation|ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.||scores on scale|||Number
725844|NCT00356421|Secondary|Change in Fasting Lipids From Baseline|As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.|At weeks 24 and 52 or last observation|ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.||mg/dl||Standard Deviation|Mean
725845|NCT00356421|Other Pre-specified|Subject Reported Health State From Baseline as Measured in the EuroQol-5 Dimensions (EQ-5D) Questionnaire|As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.|At weeks 6, 24, and 52 or last observation|ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.||scores on scale|||Number
725846|NCT00356421|Secondary|Blood Glucose Values From Baseline Determined by Home-monitored Blood Glucose (Subject Recorded Worksheet Values)|As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.|To 52 weeks.|ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.||mg/dl|||Number
725847|NCT00356421|Secondary|Change From Baseline in Prandial Insulin Doses|As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.|To 52 weeks|ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.||IU||Standard Deviation|Mean
725848|NCT00356421|Secondary|Change From Baseline in Basal Insulin Doses|As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.|To 52 weeks|ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.||International Units (IU)||Standard Deviation|Mean
725849|NCT00356421|Secondary|Change From Baseline in Body Mass Index|As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.|At weeks 12, 24, 36, and 52 or last observation.|ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.||kilograms per meter squared (kg/m2)||Standard Deviation|Mean
725850|NCT00356421|Secondary|Change From Baseline in Body Weight|As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.|At weeks 12, 24, 36, and 52 or last observation.|ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.||kg||Standard Deviation|Mean
725851|NCT00356421|Secondary|Change From Baseline in Insulin Antibody Levels|As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.|At weeks 24 and 52 or last observation.|ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.||ml||Standard Deviation|Mean
725852|NCT00356421|Secondary|Change From Baseline in Post-prandial Blood Glucose Based on Glucometer Data and In-hospital Assessments|As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.|To 52 weeks|ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.||mg/dl||Standard Deviation|Mean
725853|NCT00356421|Secondary|Change From Baseline in Fasting Blood Glucose Based on Glucometer Data and In-hospital Assessments|As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.|To 52 weeks|ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.||mg/dl||Standard Deviation|Mean
725854|NCT00356421|Secondary|Change From Baseline in FPG|As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.|At 52 weeks or last observation|ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.||milligrams per deciliter (mg/dl)||Standard Deviation|Mean
725892|NCT00356590|Primary|Total Exposure-Adjusted Rate of Deaths|Rate of deaths within 30 days of the last dose of etanercept, adjusted for total exposure to etanercept|Up to 8 years|All enrolled participants who received at least one dose of etanercept||Deaths per 100 participant-years|||Number
725855|NCT00356421|Secondary|Percentage of Subjects Who Attained Target Fasting Plasma Glucose (FPG) Values (4.0 to 6.5 mmol/l; 72 to 117 mg/dl) From Baseline|As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.|At weeks 2, 4, 6, 12, 24, 36, and 52 or last observation.|ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.||percent|||Number
725856|NCT00356421|Secondary|Percentage of Subjects With Absolute Reduction in HbA1c Levels From Baseline of >0.5%, >0.7% and >1.0%|As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.|At 52 weeks|ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.||percent|||Number
725857|NCT00356421|Secondary|Percentage of Subjects Who Attained HbA1c Levels of <8%, <7%, <6.5%, and >=8%|As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.|At 52 weeks|ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.||percent|||Number
725858|NCT00356421|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) Percent (%)|As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.|At 52 weeks|Intent to Treat (ITT) population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.||percent|||Number
725859|NCT00356434|Secondary|DVT Prevention|positive DVT on ultrasound|up to 3 months|Data was not collected for this outcome measure, as the study was terminated prematurely.|||||
725860|NCT00356434|Primary|Patient Compliance|Nurse conducting random checks throughout hospital stay and events of noncompliance will be recorded|for 1-7 days during hospitalization|Data was not collected for this outcome measure, as the study was terminated prematurely.|||||
725861|NCT00356434|Primary|Comfort Level|Scale of 1-10 (1 being very uncomfortable and 10 being very uncomfortable) describing level of comfort during the time of device use (composite score of heat, softness, discomfort).|once during first 7 days of hospitalization|||units on a scale||Full Range|Mean
725862|NCT00356525|Secondary|Time to Treatment Failure||baseline to stopping treatment (up to 17.5 months)|Outcome measure was not analyzed due to insufficient data.||months||Standard Deviation|Mean
725863|NCT00356525|Secondary|Duration of Response||time of response to progressive disease (up to 17.5 months)|Outcome measure was not analyzed due to insufficient data.||months||Standard Deviation|Mean
725864|NCT00356525|Secondary|Time to Progressive Disease||baseline to measured progressive disease (up to 17.5 months)|Outcome measure was not analyzed due to insufficient data.||months||Standard Deviation|Mean
725865|NCT00356525|Secondary|Overall Survival|Overall survival is the number of participants who were alive when the trial was terminated.|baseline to trial termination (17.5 months)|Number of randomized participants in each category.||participants alive|||Number
725866|NCT00356525|Primary|Objective Tumor Response|Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.|baseline to time of response (up to 17.5 months)|Number of randomized participants in each category.||participants|||Number
725867|NCT00356590|Secondary|Change From Baseline to Year 2 in Sharp Score Joint Space Narrowing Subscale|Change from baseline to year 2 in the joint space narrowing subscale of the Total Sharp Score. This subscale has a range of 0 to 168, where 0 = no change and higher values represent a worsening of joint space narrowing.|Baseline, Year 2|All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and year 2||Units on a scale||Full Range|Mean
725868|NCT00356590|Secondary|Change From Baseline to Year 2 in Sharp Score Erosion Subscale|Change from baseline to year 2 in the joint erosion subscale of the Total Sharp Score. This subscale has a range of 0 to 230, where 0 = no change and higher values represent a worsening in joint erosions.|Baseline, Year 2|All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and year 2||Units on a scale||Full Range|Mean
725869|NCT00356590|Secondary|Change From Baseline to Year 2 in Total Sharp Score|Change from baseline to year 2 in Total Sharp Score. This score has a range of 0 to 398, where 0 = no change and higher scores represent a worsening of joint erosions and joint space narrowing.|Baseline, Year 2|All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and year 2||Units on a scale||Full Range|Mean
725870|NCT00356590|Primary|Death|Death of the participant on study up to 30 days after the last dose of etanercept|Up to 8 years|All enrolled participants who received at least one dose of etanercept||Participants|||Number
725871|NCT00356590|Secondary|Percent Improvement in Duration of Morning Stiffness From Baseline to Month 12|Percent improvement in the duration of morning stiffness from baseline to month 12|Baseline and month 12|All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and month 12||Percent change||Standard Deviation|Mean
725872|NCT00356590|Secondary|Percent Improvement in C-Reactive Protein From Baseline to Month 12|Percent improvement in C-reactive protein from baseline to month 12|Baseline and month 12|All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and month 12||Percent change||Standard Deviation|Mean
725912|NCT00356863|Other Pre-specified|Anthropometric Measures|Measurements of body mass index (BMI)|1 year|||kg/m^2||95% Confidence Interval|Mean
725873|NCT00356590|Secondary|Percent Improvement in Mental Component Summary Score of SF-36 From Baseline to Month 12|Percent improvement in the Mental Component Summary Score of the Short Form 36 Health Survey (SF-36) from baseline to month 12. This score has a range of 0 to 100, with higher scores indicating better health.|Baseline and month 12|All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and month 12||Percent change||Standard Deviation|Mean
725874|NCT00356590|Secondary|Percent Improvement in the Physical Component Summary Score for SF-36 From Baseline to Month 12|Percent improvement in the Physical Component Summary Score for the Short Form 36 Health Survey (SF-36) from baseline to month 12. This score has a range of 0 to 100, with higher scores indicating better health.|Baseline and month 12|All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and month 12||Percent change||Standard Deviation|Mean
725875|NCT00356590|Secondary|Percent Improvement in HAQ DI From Baseline to Month 12|Percent improvement in the Health Assessment Questionnaire Disability Index (HAQ DI) from baseline to month 12.|Baseline and month 12|All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and month 12||Percent change||Standard Deviation|Mean
725876|NCT00356590|Secondary|Percent Improvement in Swollen Joint Count From Baseline to Month 12|Percent improvement in swollen joint count (based on up to 68 joints) from baseline to month 12.|Baseline and month 12|All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and month 12||Percent change||Standard Deviation|Mean
725877|NCT00356590|Secondary|Percent Improvement in Tender Joint Count From Baseline to Month 12|Percent improvement in tender joint count (based on up to 71 joints) from baseline to month 12. Tender joints were assessed clinically, and the number of such joints was counted at each time point.|Baseline and month 12|All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and month 12||Percent change||Standard Deviation|Mean
725878|NCT00356590|Secondary|Percent Improvement in Participant Pain Visual Analog Scale From Baseline to Month 12|"Percent improvement in the Participant Pain Visual Analog Scale (VAS) from baseline to month 12, using a 10 cm scale ranging from no pain (0 cm) to severe pain (10 cm)."|Baseline and month 12|All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and month 12||Percent change||Standard Deviation|Mean
725879|NCT00356590|Secondary|Percent Improvement in Participant Global Assessment of Disease Status From Baseline to Month 12|Percent improvement in the Participant Global Assessment of disease status from baseline to month 12, assessed using a 0 - 10 Likert scale, where 0 = asymptomatic and 10 = severe symptoms|Baseline and Month 12|All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and month 12||Percent change||Standard Deviation|Mean
725880|NCT00356590|Secondary|Percent Improvement in Physician Global Assessment of Disease Status From Baseline to Month 12|Percent improvement in the Physician Global Assessment of disease status from baseline to month 12, assessed using a 0 - 10 Likert scale, where 0 = asymptomatic and 10 = severe symptoms|Baseline and month 12|All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and month 12||Percent change||Standard Deviation|Mean
725881|NCT00356590|Secondary|Standardized Incidence Rate for All SEER Cancers|Standardized incidence rate for all cancers tracked by the National Cancer Institute's Surveillance Epidemiology and End Results (SEER) system, calculated as the ratio of the observed to expected age- and sex-adjusted incidence rates (per person-year) of cancer. Expected rates were based on 1998-2002 SEER data.|Up to 8 years|All participants who received at least one dose of etanercept||Standardized incidence rate||95% Confidence Interval|Mean
725882|NCT00356590|Secondary|ACR70 Response at Month 12|American College of Rheumatology (ACR) 70, defined as a 70% improvement in both tender and swollen joints (78 joints) and a 70% improvement in 3 of 5 items (including physician and patient global assessments), in adults|Baseline and month 12|All enrolled participants who received at least one dose of etanercept and had available data at month 12||Participants|||Number
725883|NCT00356590|Secondary|ACR50 Response at Month 12|American College of Rheumatology (ACR) 50, defined as a 50% improvement in both tender and swollen joints (78 joints) and a 50% improvement in 3 of 5 items (including physician and patient global assessments), in adults|Baseline and month 12|All enrolled participants who received at least one dose of etanercept and had available data at month 12||Participants|||Number
725884|NCT00356590|Secondary|ACR20 Response at Month 12|American College of Rheumatology (ACR) 20, defined as a 20% improvement in both tender and swollen joints (78 joints) and a 20% improvement in 3 of 5 items (including physician and patient global assessments), in adults|Baseline and month 12|All enrolled participants who received at least one dose of etanercept and had available data at month 12||Participants|||Number
725885|NCT00356590|Secondary|Dosing Period|Duration of etanercept dosing|Up to 8 years|All participants who received at least one dose of etanercept||Days||Standard Deviation|Mean
725886|NCT00356590|Primary|Total Exposure Adjusted Rate of Serious Adverse Events|Rate of serious adverse events adjusted to total exposure to etanercept (events / exposure * 100)|Up to 8 years|All enrolled participants who received at least one dose of etanercept||Events per 100 patient-years|||Number
725887|NCT00356590|Primary|Serious Infectious Event|Occurrence of one or more serious infectious events within the participant on study within 30 days of the last dose of study medication|Up to 8 years|All enrolled participants who received at least one dose of etanercept||Participants|||Number
725888|NCT00356590|Primary|Lymphoma|Occurrence of one or more lymphomas on study within 30 days of the last dose of etanercept|Up to 8 years|All enrolled participants who received at least one dose of etanercept||Participants|||Number
725889|NCT00356590|Primary|Malignancy|Occurrence of one or more malignancies within the participant on study within 30 days of the last dose of etanercept|Up to 8 years|All enrolled participants who received at least one dose of etanercept||Participants|||Number
725890|NCT00356590|Primary|Total Exposure Adjusted Rate of Lymphomas|Rate of lymphomas occurring on study within 30 days of the last dose of etanercept, adjusted for total exposure to etanercept|Up to 8 years|All enrolled participants who received at least one dose of etanercept||Lymphomas per 100 participant-years|||Number
725913|NCT00356863|Other Pre-specified|Medical Service Utilization|Visits to the emergency department during the year following CABG surgery|1 year|||ER visits|||Number
725894|NCT00356590|Secondary|ACR20 Response at Month 3|American College of Rheumatology (ACR) 20, defined as a 20% improvement in both tender and swollen joints (78 joints) and a 20% improvement in 3 of 5 items (physician and patient global assessments, patient pain assessment, patient self-assessed disability, and acute-phase C-reactive protein or erythrocyte sedimentation rate)|Baseline and month 3|All enrolled participants who received at least one dose of etanercept and had available data at month 3||Participants|||Number
725895|NCT00356590|Primary|Total Exposure to Etanercept With Gaps|Total participant exposure to etanercept (Enbrel) with gaps, calculated as the sum of the times on treatment for all participants. Gaps of up to 14 days from the last treatment in a previous Etanercept study were ignored in calculating time on treatment.|Up to 8 years|All enrolled participants who received at least one dose of etanercept||Participant-years|||Number
725896|NCT00356811|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations.|From the start of study medication until 28 days after the last dose (up to Study Week 381)|ITT Population||Participants|||Number
725897|NCT00356811|Secondary|Overall Survival|Overall survival is defined as the interval between the date of treatment start and the date of death due to any cause. For participants who did not die, follow-up was censored as the date of last contact. For participants who did not die, follow-up was censored at the date of last contact.|From the date of the first dose until the date of death due to any cause (up to Week 86)|ITT Population||weeks||95% Confidence Interval|Median
725898|NCT00356811|Secondary|Progression-free Survival, as Assessed by the IRC and the Investigator|Progression-free survival is defined as the interval between the start date of treatment and the date of radiological disease progression or death due to any cause, whichever occurs first. Participants who did not progress in their disease were censored on the date of their last radiological assessment preceding the start of any additional anti-cancer therapy. PD is defined as at least a 20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-TLs. Responses were confirmed at a subsequent assessment made no less than 28 days after the original response.|From the start date of treatment until the date of radiological disease progression or death due to any cause, whichever occurs first (up to Week 86)|ITT Population||weeks||95% Confidence Interval|Median
725899|NCT00356811|Secondary|Time to Progression, as Assessed by the IRC and the Investigator|Time to progression is defined as the interval between the start date of treatment and the date of radiological disease progression or death due to breast cancer, whichever occurs first. Participents who did not progress or die were censored on the date of their last radiological assessment preceding the start of any additional anti-cancer therapy. PD is defined as at least a 20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-TLs. Responses were confirmed at a subsequent assessment made no less than 28 days after the original response.|From the start date of treatment until the date of radiological disease progression or the date of death due to breast cancer (up to Week 86)|ITT Population||weeks||95% Confidence Interval|Median
725900|NCT00356811|Secondary|Time to Response, as Assessed by the Investigator|Time to response is defined as the time from randomization until the first documented evidence of a PR or CR (whichever status is recorded first). Analysis was based on responses confirmed at a repeat assessment made at least 4 weeks after the initial response, with the time to response taken as the first time the response was observed, not the confirmation assessment. Participants who withdraw with no tumor response were censored at the date of withdrawal from the study. CR is defined as the disappearance of all TLs and non-TLs. PR is defined as at least a 30% decrease in the sum of the LD of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL(s). PD is defined as at least a 20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-TLs.|From randomization until the first documented evidence of a PR or CR (up to Week 86)|ITT Population. Only those participants with CR or PR were analyzed.||Weeks||95% Confidence Interval|Median
725901|NCT00356811|Secondary|Time to Response, as Assessed by the IRC|Time to response is defined as the time from randomization until the first documented evidence of a PR or CR (whichever status is recorded first). Analysis was based on responses confirmed at a repeat assessment made at least 4 weeks after the initial response, with the time to response taken as the first time the response was observed, not the confirmation assessment. Participants who withdraw with no tumor response were censored at the date of withdrawal from the study. CR is defined as the disappearance of all TLs and non-TLs. PR is defined as at least a 30% decrease in the sum of the LD of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL(s). PD is defined as at least a 20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-TLs.|From randomization until the first documented evidence of a PR or CR (up to Week 86)|ITT Population. Only those participants with CR or PR were analyzed.||weeks||95% Confidence Interval|Median
725914|NCT00356863|Other Pre-specified|Biochemical Markers|glucose, total cholesterol, triglycerides, low density lipoprotein (LDL) cholesterol. Data regarding these biochemical markers was collected from medical available documents at the homes of the patients. In many cases this data was unavailable. Reported values are only available for a subpopulation.|1 year|||mg/dl||95% Confidence Interval|Mean
725989|NCT00358735|Primary|Events of Deep Vein Thrombosis (DVT)|"10-12 days post-op: All of the patients underwent Routine bilateral compression Doppler.
Day of surgery and up to 3 months post-op: Suspected clinical signs and symptoms DVT events were confirmed by standard diagnostic objective methods"|10-12 days post-op; and from day of surgery and up to 3 months if symptomatic|||Events|Participants||Number
725990|NCT00358826|Other Pre-specified|Change From Baseline in Percent Stenosis||Baseline and 24 weeks|Evaluable Population||Percentage||95% Confidence Interval|Least Squares Mean
725902|NCT00356811|Secondary|Duration of Response (DoR), as Assessed by the Investigator|DoR is defined for the subset of participants who had a confirmed CR (disappearance of all TLs and non-TLs) or PR (>=30% decrease in the sum of the LD of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL[s]) as the time from the first documented evidence of a CR or PR until the first documentation of radiological PD or death due to breast cancer, if sooner. PD is defined as a >=20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-TLs. For participants who did not progress or die, DoR was censored on the date of the last radiological scan. If a participant had only a Baseline visit or did not have a date of a radiological scan that was later than the date of initiation of anti-cancer therapy, DoR was censored at the start date of treatment.|From the first documented evidence of a PR or CR until the earlier of the date of disease progression or the date of death due to breast cancer (up to Week 86)|ITT Population. Only those participants with CR or PR were analyzed.||Weeks||95% Confidence Interval|Median
725903|NCT00356811|Secondary|Duration of Response (DoR), as Assessed by the IRC|DoR is defined for the subset of participants who had a confirmed CR (disappearance of all TLs and non-TLs) or PR (>=30% decrease in the sum of the LD of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL[s]) as the time from the first documented evidence of a CR or PR until the first documentation of radiological PD or death due to breast cancer, if sooner. PD is defined as a >=20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-TLs. For participants who did not progress or die, DoR was censored on the date of the last radiological scan. If a participant had only a Baseline visit or did not have a date of a radiological scan that was later than the date of initiation of anti-cancer therapy, DoR was censored at the start date of treatment.|From the first documented evidence of a PR or CR until the earlier of the date of disease progression or the date of death due to breast cancer (up to Week 86)|ITT Population. Only those participants with CR or PR were analyzed.||weeks||95% Confidence Interval|Median
725904|NCT00356811|Secondary|Number of Participants With a Best Overall Response (OR) of Confirmed Complete Response (CR) or Partial Response (PR), as Assessed by the Investigator|OR is defined as the number of participants achieving either a CR or PR, per RECIST. The best OR is defined as the best response recorded from the start of treatment until progressive disease (PD)/recurrence. CR is defined as the disappearance of all target lesions (TLs) and non-TLs. PR is defined as at least a 30% decrease in the sum of the longest diameters (LD) of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL(s), as assessed by the Investigator. PD is defined as at least a 20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-TLs. Responses were confirmed at subsequent assessments made >=28 days after the original response. Participants with an unknown or missing response are treated as non-responders.|From the first dose of study medication to the first documented evidence of a confirmed CR or PR (up to Week 86)|ITT Population||Participants|||Number
725905|NCT00356811|Primary|Number of Participants With a Best Overall Response (OR) of Confirmed Complete Response (CR) or Partial Response (PR), as Assessed by the Independent Review Committee (IRC)|OR is defined as the number of participants achieving either a CR or PR, per Response Evaulation Criteria in Solid Tumors (RECIST). The best OR is defined as the best response recorded from the start of treatment until progressive disease (PD)/recurrence. CR is defined as the disappearance of all target lesions (TLs) and non-TLs. PR is defined as at least a 30% decrease in the sum of the longest diameters (LD) of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL(s), as assessed by the IRC. PD is defined as at least a 20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-TLs. Responses were confirmed at subsequent assessments made >=28 days after the original response. Participants with an unknown or missing response are treated as non-responders.|From the first dose of study medication to the first documented evidence of a confirmed CR or PR (up to Week 86)|Intent-to-Treat (ITT) Population: all participants who received study medication.||Participants|||Number
725906|NCT00356863|Other Pre-specified|Blood Pressure|The pooled mean of 3 blood pressure measurements taken during the interview|1 year follow up|||mm Hg||95% Confidence Interval|Mean
725907|NCT00356863|Secondary|MacNew Heart Disease Health Related Quality of Life (HRQL) Scale. A Self-administered Heart Disease-specific Health-related Quality of Life (HRQL) Instrument.|MacNew questionnaire (MACNEW). A self-administered heart disease-specific health-related quality of life (HRQL) instrument. The MacNew is a modification of the original interviewer-administered Quality of Life after Myocardial Infarction [QLMI] instrument. It addresses three major HRQL domains, the Emotional, Physical, and Social domains which can be combined to give a Global HRQL score. The MacNew consists of 27 items. The total mean score ranges between 1 and 7, where higher score means better HRQL.|1 year|The N for this outcome is the number of patients for whom there are follow-up data after one year.||Scores on a scale||Standard Deviation|Mean
725908|NCT00356863|Other Pre-specified|Physical Activity|"Self-reported physical activity using a physical activity questionnaire validated in Hebrew. Details of the study validating the instrument: Development of a Hebrew questionnaire to be used in epidemiological studies to assess physical fitness--validation against sub maximal stress test and predicted VO2max. Ken-Dror G, Lerman Y, Segev S, Dankner R. Harefuah. 2004 Aug;143(8):566-72, 623. Hebrew. PMID: 15523807 VO2max=maximal oxygen uptake"|1 year|All patients who were interviewed 1-year after CABG surgery and responded to the physical activity questionnaire||patients|||Number
725909|NCT00356863|Other Pre-specified|Depression & Anxiety|Score in the HADS (hospital Anxiety and Depression Scale) screening for anxiety and depression. This is a 14 item scale, 7 items for anxiety and 7 items for depression. Each item can score 0-3 (0=good, 3=bad) and the total score for each scale varies between 0 (no depression/anxiety) to 21 (clinical depression/anxiety requiring medical intervention)|1 year|All patients who completed the Hospital Anxiety and Depression Scale (HADS)||HADS score||Standard Deviation|Mean
725910|NCT00356863|Other Pre-specified|Employment Status|Number of patients fully employed in each arm|1 year|||patients|||Number
725911|NCT00356863|Other Pre-specified|Lifestyle Habits (i.e. Smoking)||1 year|||patients|||Number
725915|NCT00356863|Other Pre-specified|Cardiovascular Morbidity|All hospitalizations which occured during the 1 year follow-up and were due to acute myocardial infarction (International Classification of Disease 9th version (ICD-9) codes 410.), angina pectoris (ICD-9 codes 413.9), stroke/ transient ischemic attack (TIA) (ICD-9 codes 436.), and all surgical procedures which occured during the 1 year follow-up: CABG or coronary catheterizations (ICD-9 codes 36.), endarterectomies (ICD-9 codes 38.0 and 39.0).|1 year|All patients who were exposed to the educational intervention at baseline and who were contacted a year later and gave information regarding participation in cardiac rehabilitation during the follow up year.||events|Participants||Number
725916|NCT00356863|Primary|Number of Patients Participating in Cardiac Rehabilitation Programs (CRPs)1-year Post Coronary Artery Bypass Grafting (CABG)Surgery in the Intervention and Control Groups|The number of cardiac patients who participated in cardiac rehabilitation programs during the year following coronary artery bypass grafting surgery in the control and the intervention groups.|1 year|All patients alive at 1-year follow up who gave information on participation in cardiac rehabilitation programs (CRPs) at any time during the year following surgery (and before follow up assessment). This information was obtained via a face-to-face interview or by telephone interview.||participants|||Number
725917|NCT00356889|Secondary|Duration of Response|Point estimates and 95% confidence intervals were calculated using the method of Duffy and Santner (1987).|From the date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented, assessed up to 3 years|There were 6 patients with a confirmed Partial Response.||months||95% Confidence Interval|Median
725918|NCT00356889|Secondary|Time to Disease Progression|Estimated using the method of Kaplan-Meier (1958).|From registration to documentation of disease progression, assessed up to 3 years|||months||95% Confidence Interval|Median
725919|NCT00356889|Secondary|Survival Time|Estimated using the method of Kaplan-Meier (1958).|From registration to death due to any cause, assessed up to 3 years|||months||95% Confidence Interval|Median
725920|NCT00356889|Primary|Number of Confirmed Tumor Responses.|"Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the target lesions.
A confirmed tumor response is defined to be either a Complete Response or a Partial Response noted as the objective status on 2 consecutive evaluations at least 4 weeks apart. Confirmed tumor responses will be evaluated using the first 6 cycles of treatment. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment and had one post-baseline disease assessment will be evaluable for response. Forty-nine of the 53 eligible patients had at least one post-baseline disease assessment and were evaluable for this endpoint."|After 6 courses of treatment. Each course lasts 28 days.|||participants|||Number
725921|NCT00351351|Primary|Kidney Stone Clearance Rate|stone clearance rate calculated in mm^2/min per protocol specification|6 months|Sample size calculations were performed using a two-sided Student’s t-test with a power of 90% and a significance level of α = 0.05||mm^2/min||Full Range|Mean
725922|NCT00351377|Secondary|Overall Treatment Effects for for Health-related Quality of Life Assessed by the Patient|"Assessed using the Overall Treatment Effects for health-related quality of life questionnaire. Possible answers were: Improved, about the same, or worse. The questionnaire was completed by the patient."|6-8 week|Intention to treat population consisting of all enrolled participants who received study medication.||Participants|||Number
725923|NCT00351377|Secondary|Overall Treatment Effects for GI Symptoms Assessed by the Patient|"Assessed using the Overall Treatment Effects for GI symptoms questionnaire. The question was: Has there been any change in the participant’s GI symptoms since his/her last study visit? Please indicate if there has been any change in his/her symptoms. The possible answers were: Improved, about the same, or worse. The questionnaire was completed by the patient."|6-8 week|Intention to treat population consisting of all enrolled participants who received study medication.||Participants|||Number
725924|NCT00351377|Secondary|Overall Treatment Effects for GI Symptoms Assessed by the Physician|"Assessed using the Overall Treatment Effects for GI symptoms questionnaire. The question was: Has there been any change in the participant’s GI symptoms since his/her last study visit? Please indicate if there has been any change in his/her symptoms. The possible answers were: Improved, about the same, or worse. The questionnaire was completed by the physician."|6-8 week|Intention to treat population consisting of all enrolled participants who received study medication.||Participants|||Number
725925|NCT00351377|Secondary|Changes in Psychological General Well-Being Index (PGWB) Subscales After Conversion to Enteric-coated Mycophenolate Sodium|The change from baseline to the 6-8 week visit for each of the six subscores (each ranging from 0-5) of the PGWB were analyzed individually. Each of the subscores was transformed to fit a range from 0-100. Lower scores indicate more unfavorable conditions, so an increase in score indicates an improvement in symptoms.|Baseline and 6-8 weeks|Intention to treat (ITT) population consisting of all enrolled participants who received study medication.||Scores on a scale||Standard Deviation|Mean
725926|NCT00351377|Secondary|Changes in Psychological General Well-Being Index (PGWB) After Conversion to Enteric-coated Mycophenolate Sodium|The PGWB consists of 22 single items (each ranging from 0-5) with 7 dimensions (including the total score) to be calculated. Lower scores indicate more unfavorable conditions. The total raw score is calculated by summing up all of the single items and thus has a hypothetical range from 0-110 score points. This raw score is further transformed using the formula: (raw score / 110) x 100 to fit a range from 0-100.|Baseline and 6-8 weeks|Intention to treat (ITT) population consisting of all enrolled participants who received study medication.||Scores on a scale||Standard Deviation|Mean
725927|NCT00351377|Secondary|Changes in the GI-related Quality of Life Subscales After Conversion to Enteric-coated Mycophenolate Sodium|The 5 different subscales of the GI-related Quality of Life (GIQLI) were analyzed separately by calculating the average value of the items that were included in the respective subscore. Thus, the theoretical range for each of the subscores was the same as for the single items, i.e. 0-4 score points. An increase in the subscale score indicates an improvement in symptoms.|Baseline and 6-8 weeks|Intention to treat (ITT) population consisting of all enrolled participants who received study medication.||Scores on a scale||Standard Deviation|Mean
725968|NCT00357162|Secondary|Overall Survival|Estimated using the method of Kaplan-Meier.|From date of registration to the date of last follow-up or death due to any cause, assessed up to 3 years|||months||95% Confidence Interval|Median
725969|NCT00357162|Secondary|Time to Progression|Estimated using the method of Kaplan-Meier.|Time from registration to the date of progression or last follow-up, assessed up to 3 years|||months||95% Confidence Interval|Median
725928|NCT00351377|Secondary|Changes in GI-related Quality of Life Index (GIQLI), After Patients Are Converted From MMF to Enteric-coated Mycophenolate Sodium|Assessed by changes in the Gastrointestinal Quality of Life Index (GIQLI) from Baseline visit to the 6-8 week visit. The GIQLI is a 36-item questionnaire and consists of 5 different subscales. The total score was calculated as the sum of the 36 single items which each ranged from 0-4, leading to a hypothetical range from 0-144 score points (lower scores indicate more unfavorable conditions). The mean change was calculated as (6-8 week visit value) minus (Baseline value).|Baseline and 6-8 weeks|Intention to treat (ITT) population consisting of all enrolled participants who received study medication.||Scores on a scale||Standard Deviation|Mean
725929|NCT00351377|Secondary|Changes in the GI Symptom Severity Subscales After Conversion to Enteric-coated Mycophenolate Sodium|Changes in GI symptom severity was measured by changes in the total scores of 5 subscales (reflux, diarrhea, constipation, abdominal pain and indigestion) of the Gastrointestinal Symptom Rating Scale (GSRS) from baseline visit to the visit at 6-8 weeks. The GSRS is a 15-item instrument with a mean subscale score ranging from 1 (no discomfort) to 7 (very severe discomfort).|Baseline and 6-8 weeks|Intention to treat (ITT) population consisting of all enrolled participants who received study medication.||Scores on a scale||Standard Deviation|Mean
725930|NCT00351377|Primary|Changes in GI Symptom Severity After Conversion From Mycophenolate Mofetil (MMF) to Enteric-coated Mycophenolate Sodium (EC-MPS)|Changes in GI symptom severity was measured by changes in the Gastrointestinal Symptom Rating Scale (GSRS) total score from baseline visit to the visit at 6-8 weeks. This total score was calculated as the average of the 15 single items (each ranging from 1-7 score points) and thus also had a range from 1-7 score points. Higher values indicate more unfavorable conditions.|Baseline and 6 - 8 weeks|Intention to treat (ITT) population consisting of all enrolled participants who received study medication.||Scores on a scale||Standard Deviation|Mean
725931|NCT00351416|Primary|FSH Level|Difference in FSH peak following letrozole administration compared with control cycle|EFP: average of menstrual cycle day 6 in the EFP; LFP: average of 2 days after follicle size of 16 mm|||IU/L||Standard Error|Mean
725932|NCT00356915|Secondary|Clinical Improvement Compared to Placebo|"Clinical Improvement consisted of a mycological cure and an Investigator's Global Assessment (IGA) score less than or equal to 1 at week 52.
The Investigator's Global Assessment(IGA)assesses the overall severity of onychomycosis on the target toenail and takes into consideration, onycholysis, hyperkeratosis and percent nail involvement.
0 = Clinical Cure: No evidence of onychomycosis.
1 = Clinical Improvement: Minimal evidence of onychomycosis. 2 = Mild: ≤25% dystrophy and/or onycholysis. 3 = Moderate: ≤50% dystrophy with onycholysis. 4 = Severe: >50% dystrophy with onycholysis."|12 months|Intent to treat (ITT)||percentage of participants|||Number
725933|NCT00356915|Secondary|Clinical Improvement of the Target Toenail|"Clinical Improvement consisted of a mycological cure and an Investigator's Global Assessment (IGA) score less than or equal to 1 at week 52.
The Investigator’s Global Assessment (IGA) assesses the overall severity of onychomycosis on the target toenail and takes into consideration, onycholysis, hyperkeratosis and percent nail involvement.
0 = Clinical Cure: No evidence of onychomycosis.
1 = Clinical Improvement: Minimal evidence of onychomycosis. 2 = Mild: ≤25% dystrophy and/or onycholysis. 3 = Moderate: ≤50% dystrophy with onycholysis. 4 = Severe: >50% dystrophy with onycholysis."|12 months|||percentage of participants|||Number
725934|NCT00356915|Primary|Complete Cure - Itraconazole Tablets Compared to Itraconazole Capsules|The primary efficacy endpoint was Compete Cure (consisting of a Clinical Cure and a Mycological Cure) at week 52. In this study, Clinical Cure was defined as an Investigator’s Global Assessment (IGA) score of 0 for the target toenail; Mycological Cure was defined as a negative potassium hydroxide (KOH) examination and a negative culture outcome for dermatophytes of the target toenail. The efficacy analyses were conducted to demonstrate the non-inferiority of 1 itraconazole 200-mg tablet to 2 itraconazole 100-mg capsule.|12 months|Intent to treat (ITT).||Percentage of participants|||Number
725935|NCT00356915|Primary|Clinical and Mycological Cure of Target Toenail|"This study was designed to evaluate the superiority of itraconazole tablets to placebo tablets.
Clinical Cure was defined as an IGA score of 0 for the target toenail; Mycological Cure was defined as a negative potassium hydroxide (KOH) exam and a negative culture for dermatophytes of the target toenail."|1 year|Intent to treat (ITT).||Percentage of participants|||Number
725936|NCT00357006|Secondary|Change in Hormone Levels Over Trial Duration||Baseline and weeks 1, 4 and 8.||||||
725937|NCT00357006|Secondary|Scores on Adverse Symptom Checklist at Trial Completion||Baseline and weeks 1, 2, 4, 6, 8||||||
725938|NCT00357006|Secondary|Scores on MADRS at Trial Completion||Baseline and week 8||||||
725939|NCT00357006|Secondary|Cognitive Performance (RBANS Scores)||baseline and week 8||||||
725940|NCT00357006|Primary|Positive and Negative Syndrome Scale (PANSS)|The Positive and Negative Syndrome Scale (PANSS) is a well validated, standardized method of evaluating and monitoring psychotic symptoms. The PANSS assesses: positive (hallucinations, delusions, thought disorder), negative (blunted affect, abstract thinking and general symptomatology. The positive and negative subscale each consist of 7 items rated from 1(absent) - 7(extreme) with a minimum score = 7, maximum score = 49. The general subscale consists of 16 items with a minimum score = 16, maximum score = 112. A Total PANSS score (positive+ negative + general scores) has a minimum of 30 and maximum of 210. Higher scores represent more severity in symptoms.|Baseline and week 8|||units on a scale||Standard Deviation|Mean
725941|NCT00357032|Secondary|Toxicity as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0||Up to 1 year||||||
725942|NCT00357032|Secondary|Duration of Response||Up to 1 year||||||
725943|NCT00357032|Secondary|Overall Survival|Survival endpoints will be summarized by the method of Kaplan-Meier|Up to 1 year|||Months||95% Confidence Interval|Median
725944|NCT00357032|Primary|Complete Response Rate|Clinical responses were measured according to International Working Group criteria. Bone marrow studies were repeated at a minimum of every three cycles.|Up to 1 year|||percentage of subjects|||Number
725945|NCT00357097|Secondary|Change From Average Baseline Scores of Subscale “Sleep Quantity” (Hours) of the Medical Outcomes Study Sleep Scale (MOS-SS) to Final Visit After 12 Weeks||Baseline and after Week 12|Intent to Treat (ITT): All patients of the safety population with any psychometric data at baseline (within a single questionnaire)||Score on a Scale||Standard Deviation|Mean
725991|NCT00358826|Other Pre-specified|Change From Baseline in Mean Plaque Density|Plaque density is expressed in Hounsfield Units (HU)|Baseline and 24 weeks|Evaluable Population||HU||95% Confidence Interval|Least Squares Mean
725946|NCT00357097|Secondary|Change From Average Baseline Scores of Subscale “Sleep Adequacy” of the Medical Outcomes Study Sleep Scale (MOS-SS)to Final Visit After 12 Weeks|Medical Outcome Study Sleep Scale (MOS-SS)-is a 12 item questionaire assessing sleep disturbance, sleep adequacy, somnolence, quantity of sleep, snoring, and awakening short of breath or with a headache. 10 question score from 1-6, 1 question scores 1-5 and 1 question asks average number of hours sleep each night.|Baseline and after Week 12|Intent to Treat (ITT): All patients of the safety population with any psychometric data at baseline (within a single questionnaire)||Score on a Scale||Standard Deviation|Mean
725947|NCT00357097|Secondary|Change From Average Baseline Scores of Subscale “Sleep Disturbance” of the Medical Outcomes Study Sleep Scale (MOS-SS) to Final Visit After 12 Weeks|Medical Outcome Study Sleep Scale (MOS-SS)-is a 12 item questionaire assessing sleep disturbance, sleep adequacy, somnolence, quantity of sleep, snoring, and awakening short of breath or with a headache. 10 question score from 1-6, 1 question scores 1-5 and 1 question asks average number of hours sleep each night.|Baseline and after Week 12|Intent to Treat (ITT): All patients of the safety population with any psychometric data at baseline (within a single questionnaire)||Score on a Scale||Standard Deviation|Mean
725948|NCT00357097|Secondary|Change From Average Baseline Score of Subscale of “Somnolence” in the Medical Outcomes Study Sleep Scale (MOS-SS) to Final Visit After 12 Weeks|Medical Outcome Study Sleep Scale (MOS-SS)-is a 12 item questionaire assessing sleep disturbance, sleep adequacy, somnolence, quantity of sleep, snoring, and awakening short of breath or with a headache. 10 question score from 1-6, 1 question scores 1-5 and 1 question asks average number of hours sleep each night.|Baseline and after Week 12|Intent to Treat (ITT): All patients of the safety population with any psychometric data at baseline (within a single questionnaire)||Score on a Scale||Standard Deviation|Mean
725949|NCT00357097|Secondary|Percentage of Participants With “Much Improved” or “Very Much Improved” on the Clinical Global Impression-Global Improvement Scale After 1, 4 and 12 Weeks|The CGI-I assesses the investigator's impression of the patient's current illness. The time span is the week before the rating and the score range: 1-very much improved, 2-much improved, 3-minimally improved, 4-no change, 5- minimally worse, 6-much worse, to 7-very much worse.|Week 1, Week 4, Week 12|Intent to Treat (ITT): All patients of the safety population with any psychometric data at baseline (within a single questionnaire)||Percentage of Participants|||Number
725950|NCT00357097|Secondary|Percentage of Participants With a Decrease of International Restless Legs Scale (IRLS) Scores of at Least 6 Points After 1, 4 and 12 Weeks|International Restless Legs Scale for Severity (IRLS)is a series of 10 questions which rate severity from 0-4 points for various questions and total score ranks: Very severe=31-40 points, Severe=21-30 points, Moderate=11-20 points, and Mild=1-10 points, None=0 points|Week 1, Week 4, Week 12|Intent to Treat (ITT): All patients of the safety population with any psychometric data at baseline (within a single questionnaire)||Percentage of Participants|||Number
725951|NCT00357097|Secondary|Change in Average International Restless Legs Scale for Severity (IRLS) Scores in All Participants From Baseline to After 1, 4, and 12 Weeks|International Restless Legs Scale for Severity (IRLS)is a series of 10 questions which rate severity from 0-4 points for various questions and total score ranks: Very severe=31-40 points, Severe=21-30 points, Moderate=11-20 points, and Mild=1-10 points, None=0 points|Baseline, Week 1, Week 4, Week 12|Intent to Treat (ITT): All patients of the safety population with any psychometric data at baseline (within a single questionnaire)||Score on a Scale||Standard Deviation|Mean
725952|NCT00357097|Secondary|Change in Average BDI Score From Baseline to Final Visit (Week 12) in Participants With Major Depressive Episodes (Diagnosed by MINI Interview Modules A, B and C / DSM Criteria)|Becks Depression Inventory (BDI) is a 21 item self inventory evaluating symptoms of depression, cognition, and physical symptoms of fatigue, weight loss, and lack of interest in sex. The Higher the score represents most severely depressed participants. Score range for each items is 0-3 and Total score 0-63.|Baseline and Week 12|Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5). Sub-population diagnosed by MINI interview with Major Depressive Episodes: Ropinirole 91 and Placebo 34. High/Low BDI scores for this population were 46/2.||Score on a Scale||Standard Deviation|Mean
725953|NCT00357097|Secondary|Change in Average HAM-D Score From Baseline to Final Visit (Week 12) in Participants With Major Depressive Episodes (Diagnosed by MINI Interview Modules A, B and C / DSM Criteria)|The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAMD score range from 0 (not ill) to 54 (severely ill).|Baseline and Week 12|Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5). Sub-population diagnosed by MINI interview with Major Depressive Episodes: Ropinirole 90 and Placebo 31.||Score on a Scale||Standard Deviation|Mean
725954|NCT00357097|Secondary|Change in Average MADRS Score From Baseline to Final Visit (Week 12) in Participants With Major Depressive Episodes (Diagnosed by MINI Interview Modules A, B and C / DSM Criteria)|Montgomery-Asberg Depression Rating Scale (MADRS)is a 10 item questionaire preformed during a clinical interview asking broad to detailed questions about symptoms which allows a precise rating of severity of symptoms of the past week. Questions are scored 0-6. Total Score 0-60, the higher the score indicates the most severely depressed patients.|Baseline and Week 12|Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5). Sub-population diagnosed by MINI interview with Major Depressive Episodes: Ropinirole 93 and Placebo 34||Score on a Scale||Standard Deviation|Mean
725955|NCT00357097|Secondary|Percentage of Participants (“Responder”) With a Decrease of MADRS Total Score of at Least 6 Points After 12 Weeks Compared to Baseline in Subjects With Signs of at Least Moderate Depression at Baseline (MADRS Score >= 18)|Montgomery-Asberg Depression Rating Scale (MADRS)is a 10 item questionaire preformed during a clinical interview asking broad to detailed questions about symptoms which allows a precise rating of severity of symptoms of the past week. Questions are scored 0-6. Total Score 0-60, the higher the score indicates the most severely depressed patients.|Baseline and Week 12|Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5). Sub-population with MADRS scores>=18: Ropinirole 91 and Placebo 29||Percentage of Participants|||Number
725992|NCT00358826|Other Pre-specified|Change From Baseline in Noncalcified Plaque Volume||Baseline and 24 weeks|Evaluable Population||mm^3||95% Confidence Interval|Least Squares Mean
725956|NCT00357097|Secondary|Percentage of Participants (“Responder”) With a Decrease of MADRS Total Score of at Least 6 Points After 12 Weeks Compared to Baseline|Montgomery-Asberg Depression Rating Scale (MADRS)is a 10 item questionaire preformed during a clinical interview asking broad to detailed questions about symptoms which allows a precise rating of severity of symptoms of the past week. Questions are scored 0-6. Total Score 0-60, the higher the score indicates the most severely depressed patients.|Baseline and Week 12|Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5).||Percentage of Participants|||Number
725957|NCT00357097|Secondary|Percentage of Participants With at Least Moderate Depression (HAM-D >= 15) at Baseline and in Week 12|The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAMD score range from 0 (not ill) to 54 (severely ill).|Baseline and Week 12|Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5). Sub-population with HAM-D scores>=15.||Percentage of Participants|||Number
725958|NCT00357097|Secondary|Percentage of Participants With at Least Moderate Depression (MADRS Score >= 18) at Baseline and in Week 12|Montgomery-Asberg Depression Rating Scale (MADRS)is a 10 item questionaire preformed during a clinical interview asking broad to detailed questions about symptoms which allows a precise rating of severity of symptoms of the past week. Questions are scored 0-6. Total Score 0-60, the higher the score indicates the most severely depressed patients.|Baseline and Week 12|Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at week 12).||Percentage of Participants|||Number
725959|NCT00357097|Secondary|Average Change of the Beck Depression Inventory (BDI) Total Score From Baseline to Final Visit After 12 Weeks of Treatment in Participants With Signs of an at Least Mild-moderate Depression (BDI >= 21) at Baseline|Becks Depression Inventory (BDI) is a 21 item self inventory evaluating symptoms of depression, cognition, and physical symptoms of fatigue, weight loss, and lack of interest in sex. The Higher the score represents most severely depressed participants. Score range for each items is 0-3 and total score 0-63.|Baseline and Week 12|Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5). Sub-population with BDI scores>=21: Ropinirole 75 and Placebo 28. High/Low BDI scores for this population were 46/2.||Score on a Scale||Standard Deviation|Mean
725960|NCT00357097|Secondary|Average Change of the Beck Depression Inventory (BDI) Total Score From Baseline to Final Visit After 12 Weeks of Treatment|Becks Depression Inventory (BDI) is a 21 item self inventory evaluating symptoms of depression, cognition, and physical symptoms of fatigue, weight loss, and lack of interest in sex. The Higher the score represents most severely depressed participants. Score range for each items is 0-3 and Total score 0-63.|Baseline and Week 12|Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5). High/Low BDI scores for this population were 46/2.||Score on a Scale||Standard Deviation|Mean
725961|NCT00357097|Secondary|Average Change of the HAM-D Total Score From Baseline to Final Visit After 12 Weeks of Treatment in Participants With Signs of an at Least Moderate Depression (HAM-D Score >= 15) at Baseline|The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAMD score range from 0 (not ill) to 54(severely ill).|Baseline and Week 12|Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5). Sub-population with HAM-D scores>=15: Ropinirole 93 and Placebo 33||Score on a Scale||Standard Deviation|Mean
725962|NCT00357097|Secondary|Average Change of the HAM-D (Hamilton Depression Rating Scale, 17-item-Version) Total Score From Baseline to Final Visit After 12 Weeks of Treatment|The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAMD score range from 0 (not ill) to 54 (severely ill).|Baseline and Week 12|Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5). The High/Low HAM-D scores for this population were 27/5.||Score on a Scale||Standard Deviation|Mean
725963|NCT00357097|Secondary|Average Change of the MADRS (Montgomery-Asberg Depression Rating Scale) Total Score From Baseline to Final Visit After 12 Weeks of Treatment in Participants With Signs of at Least Moderate Depression (MADRS Score: >=18)|Montgomery-Asberg Depression Rating Scale (MADRS)is a 10 item questionaire preformed during a clinical interview asking broad to detailed questions about symptoms which allows a precise rating of severity of symptoms of the past week. Questions are scored 0-6. Total Score 0-60, the higher the score indicates the most severely depressed patients.|Baseline and Week 12|Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5). Sub-population with MADRS scores>=18: Ropinirole 91 and Placebo 29. The high/Low scores for the mITT population were 32/11.||Score on a Scale||Standard Deviation|Mean
725964|NCT00357097|Primary|Average Change of the MADRS (Montgomery-Asberg Depression Rating Scale) Total Score From Baseline to Final Visit After 12 Weeks of Treatment|Montgomery-Asberg Depression Rating Scale (MADRS)is a 10 item questionaire preformed during a clinical interview asking broad to detailed questions about symptoms which allows a precise rating of severity of symptoms of the past week. Questions are scored 0-6. Total Score 0-60, the higher the score indicates the most severely depressed patients.|Baseline and Week 12|Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5). The High/Low scores for this population were 32/11.||Score on a Scale||Standard Deviation|Mean
725965|NCT00357110|Primary|Patients Event-free at 12 Months (Where Event = Death (From Any Cause), Disseminated Tumour Cells (DTC) Positive at 12 Months or Clinical Disease Recurrence)|Number of patients event-free|12 month period following randomisation|||Participants|||Number
725966|NCT00357162|Secondary|Toxicity of Belinostat in Patients With Myelodysplastic Syndrome|Graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Reporting events deemed at least possibly related to study treatment.|Prior to each course (every 21 days), and every 3 months for up to 3 years after completion of study treatment|||participants|||Number
725967|NCT00357162|Secondary|Duration of Response|Estimated using the method of Kaplan-Meier.|From the date of documented response until the date of progression or last follow-up, assessed up to 3 years|One participant had a confirmed Hematologica Improvement. For patient confidentiality, we are not reporting response data.|||||
725970|NCT00357162|Primary|Number of Confirmed Responses (Complete Response, Partial Response, or Hematologic Improvement) Noted on 2 Consecutive Evaluations at Least 4 Weeks Apart|"Complete Response (CR)
A CR is defined as a participant with bone marrow showing less than 5% myeloblasts with no evidence of dysplasia and with adequate peripheral blood counts for at least 2 months (hemoglobin > 11 g/dl, neutrophils ≥ 1500/mm3, platelets ≥ 100,000/mm3) and with no blasts in the peripheral.
Partial Response (PR)
All the CR criteria except bone marrow blasts decreased by ≥ 50% over pretreatment, or a less advanced WHO classification than pretreatment.
Hematologic Improvement (HI)
A 2g/dl increase in hemoglobin for participants with <11g/dl hemoglobin at pretreatment, or an increase of >30,000/mm^3 platelets for participants with <100,000/mm^3 at pretreatment, or a 100% increase in neutrophil counts for participants with <1500/mm^3 at pretreatment"|12 weeks|||participants|||Number
725971|NCT00358644|Primary|Complete Response = Morphologic Complete Remission (mCR)||1 year|Intent-to-Treat (ITT)||Participants|||Number
725972|NCT00358670|Secondary|PASI 12-month AUC (Time Adjusted Total PASI Score Over the 12 Month Period)|The PASI 12-month AUC is a time adjusted total PASI score over the 12 month (360 days) period. The AUC is a continuous measurement (not a score on a scale); and a lower value is considered better. The weighted average PASI score over 12 months (using all available PASI scores during a 12 month period [from Day 0 to 360 days]) is is obtained by using PASI 12-month AUC /360 days.|Day 0 to 360 days|Participants with at least two post Study P04563 randomization PASI scores (at least one is 330 days or more from Study P04563 randomization).||12-month PASI AUC||Standard Error|Mean
725973|NCT00358670|Secondary|PASI 6-month Area Under the Curve (AUC); (Time Adjusted Total PASI Score Over the 6 Month Period)|The PASI 6-month AUC is a time adjusted total PASI score over the 6 month (180 days) period. The AUC is a continuous measurement (not a score on a scale); a lower value is considered better and a higher value is considered worse. The weighted average PASI score over 6 months (using all available PASI scores during a 6 month period [from Day 0 to 180 days]) is obtained by using PASI 6-month AUC /180 days.|Day 0 to 180 days|Participants with at least two post Study P04563 randomization PASI scores (at least one is 150 days or more from Study P04563 randomization).||6-month PASI AUC||Standard Error|Mean
725974|NCT00358670|Secondary|Number of Participants Who Achieved PASI75 Response at Week 100|PASI75 defined as the number of participants who achieved a >=75% improvement in PASI from the original Baseline in Study P04271 (NCT00251641)|100 Weeks|Descriptive summary of all randomized subjects who completed 100 weeks (+ or - 4 weeks) of therapy. Based on best (minimum) PASI score at Week 100.||Participants|||Number
725975|NCT00358670|Secondary|Number of Participants Who Achieved PASI75 Response at Week 52|PASI75 defined as the number of participants who achieved a >=75% improvement in PASI from the original Baseline in Study P04271 (NCT00251641)|52 weeks|Descriptive summary of all randomized subjects who completed 52 weeks (+ or - 4 weeks) of therapy. Based on best (minimum) PASI score at Week 52.||Participants|||Number
725976|NCT00358670|Primary|Number of Participants Who Achieved Psoriasis Area and Severity Index 75 (PASI75) Response at Week 128|PASI75 defined as the number of participants who achieved a >=75% improvement in Psoriasis Area and Severity Index (PASI) from the original Baseline in Study P04271 (NCT00251641).|128 weeks|Due to the early termination of the study, no subjects completed 128 weeks of therapy.|||||
725977|NCT00358735|Secondary|In-Patients’ Compliance|"Total usage time with the pneumatic device (patient's compliance) was recorded using the ActiveCare+SFT device internal timer.
The compliance was calculate as total actual operation time (for the entire arm/group) divided by the total time passes since the initiation of treatment at hospital (for the entire arm/group).
The compliance is expressed as percentages."|Surgery till discharge|||percentage of usage time|||Number
725978|NCT00358735|Secondary|Serious Adverse Events|"Serious Adverse Events (SAE) is any event that prolongs hospitalization or requires re-hospitalization, that requires intervention to prevent permanent impairment or damage, that causes permanent disability, or that is life threatening.
SAE did not include Venous thrombolembolism (VTE) events (DVT and PE) and Major bleeding complications as these are outcome measures"|SAE data were collected Up to 3 months post-op|||events|||Number
725979|NCT00358735|Post-Hoc|Composite Outcome of Major Bleeding + VTE|Major bleeding + DVT events + PE Events|Day of surgery and up to 3 months|||Events|||Number
725980|NCT00358735|Post-Hoc|Changes in Hemoglobin Levels|Changes in Hemoglobin levels|After surgery untill discharge|||mean change (g/l)||Standard Deviation|Mean
725981|NCT00358735|Post-Hoc|Bleeding Index ≥ 2|Bleeding index was defined as the number of units of whole blood or packed red blood cells transfused plus the difference between the first hemoglobin value after surgery and the value prior to discharge|Surgery till discharge|||units on a scale||Standard Deviation|Mean
725982|NCT00358735|Post-Hoc|Autologous Blood Transfusion Units|Autologous blood transfusion per patient in specific treatment Group|Up to 30 days|||Avg. Unit per patient in arm||Standard Deviation|Mean
725983|NCT00358735|Post-Hoc|Allogeneic Blood Transfusion Units|Allogeneic blood transfusion per patient in specific treatment Group|Up to 30 days|||Avg. Unit per patient in arm||Standard Deviation|Mean
725984|NCT00358735|Post-Hoc|Total Number of Blood Transfusion Units|Number of blood units used (Autologous units and allogeneic units) (blood units during surgery not included)|Between the immediate postoperative measurement and discharge|||Units|Participants||Number
725985|NCT00358735|Post-Hoc|Events of Clinical Sign and Symptoms of VTE (DVT and/or PE)|Events of clinical Sign and symptoms of VTE (DVT and/or PE), confirmed by standard objective diagnostic methods|Day of surgery and up to 3 months|||Events|Participants||Number
725986|NCT00358735|Secondary|OutPatient Patients’ Compliance|"Total usage time with the pneumatic device (patient's compliance) was recorded using the ActiveCare+SFT device internal timer.
The compliance was calculate as total actual operation time (for the entire arm/group) divided by the total time passes since the initiation of home treatment (for the entire arm/group).
The compliance is expressed as percentages."|10-12 days post-op|||percentage of usage time|||Number
725987|NCT00358735|Secondary|Major Bleeding Complication|Major bleeding is defined as bleeding that requires rehospitalization or prolonged hospitalization, requires any intervention such as surgery or hematoma aspiration to prevent permanent impairment or damage, endangered critical organs, is life threatening or causes death. Data collected included bleeding index, a decrease in hemoglobin greater than/equal to 20 g/L, and number of units of blood transfused.|Up to 30 days|||Events|Participants||Number
725988|NCT00358735|Primary|Clinical PE (Pulmonary Embolism) Events|Clinical PE events PE (Pulmonary Embolism) events were confirmed by spiral CT|Day of surgery and up to 3 months|||Events|Participants||Number
725997|NCT00358917|Secondary|Percentage of Participants With New Primary Protease Mutations at Week 48|Emergence of new primary protease inhibitor mutations (i.e., mutations at codons 30, 32, 48, 50, 82, 84, and 90 that were not present at baseline).|Week 48 (End of Study)|All randomized participants who received at least 1 dose of study drug and had post baseline genotypic resistance assay results.||Percentage of Participants|||Number
725998|NCT00358917|Secondary|Virologic Response (HIV-1 RNA <50 Copies/mL) at Week 48 for Participants With 0-2 Protease Inhibitor Substitutions at Baseline Associated With Reduced Response to Lopinavir/Ritonavir|Substitutions considered in the analysis were L10F/I/R/V, K20M/N/R, L24I, L33F, M36I, I47V, G48V, I54L/T/V, V82A/C/F/S/T, and I84V as defined in the proposed United States Package Insert.|Week 48 (End of Study)|Dropouts-as-censored: participants were responders if they had HIV-1 RNA <50 copies/mL at Week 48. Participants who discontinued (d/c'd) while suppressed or w/o post baseline (BL) levels were excluded. Those d/c'd <Day 85 were excluded unless they had >=1 post BL level & didn't achieve a decrease >=1.0 log10 copies/mL, then they were nonresponders.||Percentage of Participants|||Number
725999|NCT00358917|Secondary|Mean Change From Baseline to Week 48 in Cluster of Differentiation 4 Single-Positive Thymocyte (CD4+ T) Cell Counts||Week 48 (End of Study)|All randomized participants who received at least 1 dose of study drug and who had CD4+ T cell counts at both the Baseline Visit and Week 48.||cells/microliter||Standard Error|Mean
726000|NCT00358917|Secondary|Percentage of Participants With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 50 Copies/Milliliter (mL) at Week 48||Week 48 (End of Study)|Observed data analysis using all available Week 48 data from all randomized participants who received at least 1 dose of study drug.||Percentage of Participants|||Number
726001|NCT00358917|Primary|Percentage of Participants Responding at Week 48 Based on the Food and Drug Administration (FDA) Time to Loss of Virologic Response (TLOVR) Algorithm|A participant was classified as a responder at the first of 2 consecutive human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) levels <50 copies/mL. The participant continued to be a responder until 2 consecutive values >=50 copies/mL were reached, until the final value if that value was >=50 copies/mL, or until discontinuation or death.|Week 48 (End of Study)|Intention to treat analysis of all randomized participants who received at least 1 dose of study drug.||Percentage of Participants|||Number
726002|NCT00358956|Secondary|Biochemical Response Carcinoembryonic Antigen CEA)|A patient’s best biochemical response was calculated from assessments performed at baseline and during treatment. Responders were those patients with a best biochemical response of CR or PR, confirmed by repeat assessments, which were to be performed no less than 4 weeks after the criteria for Partial Response (PR) or Complete Response (CR) were first met.|Blood samples for analysis of CTN were taken at screening (0, 1, 4, and 8 hours to determine the baseline CTN/CEA level) then every 4 weeks until discontinuation|||Participants|||Number
726003|NCT00358956|Secondary|Biochemical Response Calcitonin (CTN )|A patient’s best biochemical response was calculated from assessments performed at baseline and during treatment. Responders were those patients with a best biochemical response of CR or PR, confirmed by repeat assessments, which were to be performed no less than 4 weeks after the criteria for PR or CR were first met.|Blood samples for analysis of CTN were taken at screening (0, 1, 4, and 8 hours to determine the baseline CTN/CEA level) then every 4 weeks until discontinuation Time point(s) at which outcome measure was assessed. (Limit: 255 characters)|||Participants|||Number
726004|NCT00358956|Secondary|Symptomatic Response|Symptomatic response will be defined as at least a 50% decrease in the stool frequency (represented by a persistent decrease in stool frequency over 4 weeks), taking as reference the baseline (mean) level.|Symptomatic diarrhea was assessed using stool frequency diaries. Baseline was established using the average of the 4 days immediately prior to first dose, then weekly until discontinuation of study treatment.|||Participants|||Number
726005|NCT00358956|Secondary|World Heath Organization (WHO) Performance Status|Number of patients demonstrating an improvement from baseline to 24 weeks in WHO PS. Where WHO PS is the standard scale with patients scored (0 healthy – 5 dead) based on their physical capabilities|WHO PS assessed at screening (up to 3 weeks prior to first dose), baseline and then every 12 weeks (± 2 weeks), up to and including discontinuation of study treatment.|||Participants|||Number
726006|NCT00358956|Secondary|Disease Control Rate (DCR)|Disease control rate is defined as the number of patients who achieved disease control at 8 weeks following randomisation. Disease control at 8 weeks is defined as a best objective response of complete response (CR), partial response (PR) or stable disease (SD) >= 24 weeks|RECIST assessed at screening (up to 3 weeks prior to first dose), then every 12 weeks (± 2 weeks), from date of first dose to objective progression, up to and including discontinuation of study treatment.|||Participants|||Number
726007|NCT00358956|Secondary|Progression-Free Survival (PFS)|Median progression free survival (months) estimated from a Weibull model with corresponding 95% confidence intervals. Progression free survival is the time from randomisation until objective disease progression (determined by RECIST assessments) or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment.|RECIST assessed at screening (up to 3 weeks prior to first dose), then every 12 weeks (± 2 weeks), from date of first dose to objective progression, up to and including discontinuation of study treatment.|||Months||95% Confidence Interval|Median
726008|NCT00358956|Primary|Objective Response Rate (ORR)|"The ORR is the number of patients that are responders ie those patients with a confirmed best objective response of complete response (CR) or partial response (PR) as defined by RECIST criteria.
The categories for best objective response are CR, PR, stable disease (SD)>= 12 weeks, progressive disease (PD) or NE."|RECIST assessed at screening (up to 3 weeks prior to first dose), then every 12 weeks (± 2 weeks), from date of first dose to objective progression, up to and including discontinuation of study treatment.|||Participants|||Number
726009|NCT00359021|Secondary|Change in Plasma Viral Load Versus Baseline (ie, Mean Change in log10 Plasma Viral Load From Baseline Over Time)|In the table below, the total number of participants analyzed in the Duet Placebo and Duet TMC125 groups, respectively at each time point were: Baseline (256;247 participants), Week 24 (251;240 participants), Week 48 (235;192 participants), and Week 96 (123;69 participants).|Baseline, Week 24, Week 48, and Week 96|The intent-to-treat (ITT) population was used as the primary analysis population for the efficacy analysis and included all participants who took at least one dose of etravirine (ETR) (also known as TMC125) in the TMC125-C217 study.||log10 copies/mL||95% Confidence Interval|Mean
726010|NCT00359021|Secondary|The Percentage of Participants With Virologic Outcomes Over Time|The table below shows the percentage of participants with virologic suppression (< 50 copies/mL), the percentage of participants who were virologic failures (VF) (>50 copies/mL, discontinued prior to time X for reasons of VF or for other reasons, except for VF or adverse event, with a last viral load >50 copies/mL), and the percentage of participants with no viral load (VL) data available over time (ie, at Weeks 24, 48, and 96).|Weeks 24, 48, and 96|The intent-to-treat (ITT) population was used as the primary analysis population for the efficacy analysis and included all participants who took at least one dose of etravirine (ETR) (also known as TMC125) in the TMC125-C217 study.||Percentage of Participants|||Number
726011|NCT00359021|Primary|The Number of Participants Experiencing Adverse Events|The table below provides the number of participants who experienced Serious Adverse Events (SAEs) and Other Adverse Events (except SAEs) that started or worsened in severity during the overall TMC125-C217 treatment period. The duration of treatment ranged per patient from 1 week to 180 weeks, with a median of 62 weeks.|1 week to 180 weeks, with a median of 62 weeks|The safety analysis was carried out on the ITT population, which included all participants who received at least one dose of investigational medication.||Participants|||Number
726012|NCT00359138|Primary|Duration of Suppressive Effect of Desloratadine After Discontinuation of a 1-week Treatment|The number of days after treatment discontinuation until a measurable wheal and flare response.|Starting at Day 8|||Days||Standard Error|Mean
726013|NCT00359203|Primary|Syncope Recurrence Rate|Intention to treat analysis of percentage of patients with syncope recurrence at 2 years follow-up after study arm assignement|2 years|77 patients implanted with dual chamber pacemaker: 39 patients randomized to pacemaker OFF and 38 patients randomized to pacemaker ON||percentage of participants||95% Confidence Interval|Number
726014|NCT00359216|Primary|Apnea-Hypopnea Index|Apnea-Hypopnea Index (AHI), used to assess severity of sleep apnea based on total number of complete cessations (apnea) and partial obstructions (hypopnea) of breathing occurring per hour of sleep. Determined by the frequency of occurrence of apnea-hypopnea episodes measured during sleep at home by an Embletta device.|change from baseline (screening) at the end of 28 days of treatment|Diary data over interval of days was derived using the mean of non-missing entries. No imputation was applied to any other missing data||apnea-hypopnea episodes per hour||Standard Deviation|Mean
726015|NCT00359281|Primary|AUC0-t Nicotinuric Acid|Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for nicotinuric acid|0 to 24 hours|Pharmacokinetic||Ratio||90% Confidence Interval|Geometric Mean
726016|NCT00359281|Primary|AUC0-t Nicotinic Acid|Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for nicotinic acid|0 to 24 hours|Pharmacokinetic||Ratio||90% Confidence Interval|Geometric Mean
726017|NCT00359281|Primary|AUC0-t Rosuvastatin (Lomitapide 60 mg)|Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for rosuvastatin (Lomitapide 60 mg)|0 to 24 hours|Pharmacokinetic||Ratio||90% Confidence Interval|Geometric Mean
726018|NCT00359281|Primary|AUC0-t Atorvastatin Acid (Lomitapide 60 mg)|Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for atorvastatin acid (Lomitapide 60 mg)|0 to 24 hours|Pharmacokinetic||Ratio||90% Confidence Interval|Geometric Mean
726019|NCT00359281|Primary|AUC0-t Fenofibric Acid|Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for fenofibric acid|0 to 24 hours|Pharmacokinetic||Ratio||90% Confidence Interval|Geometric Mean
726020|NCT00359281|Primary|AUC0-t Rosuvastatin (Lomitapide 10 mg)|Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for rosuvastatin (Lomitapide 10 mg)|0 to 24 hours|Pharmacokinetic||Ratio||90% Confidence Interval|Geometric Mean
726021|NCT00359281|Primary|AUC0-t Total Ezetimibe|Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for total ezetimibe|0 to 24 hours|Pharmacokinetic||Ratio||90% Confidence Interval|Geometric Mean
726022|NCT00359281|Primary|AUC0-t Simvastatin Acid|Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for simvastatin acid|0 to 24 hours|Pharmacokinetic||Ratio||90% Confidence Interval|Geometric Mean
726023|NCT00359281|Primary|AUC0-t Simvastatin|Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for simvastatin|0 to 24 hours|Pharmacokinetic||Ratio||90% Confidence Interval|Geometric Mean
726024|NCT00359281|Secondary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)|Percent change from Baseline in LDL-C|Baseline to Day 8|Intention To Treat||Percent Change||Standard Deviation|Mean
726025|NCT00359281|Primary|Area Under Concentration-time Curve From 0 to Last Measureable Concentration (AUC0-t) Atorvastatin Acid (Lomitapide 10 mg)|Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for atorvastatin acid (Lomitapide 10 mg)|0 to 24 hour|Pharmacokinetic||Ratio||90% Confidence Interval|Geometric Mean
726026|NCT00359424|Secondary|Modified Rankin Scale (mRS) Score Dichotomized to 0-2 Versus Greater Than 2|The modified Rankin Scale (mRS) runs from 0-6 running from perfect health without symptoms to death. 0 - No symptoms at all. 1 - No significant disability. Able to carry out all usual duties and activities. 2 - Slight disability. Unable to carry out all previous activities but able to look after own affairs without assistance. 3 - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to walk unassisted and unable to attend to own bodily needs without assistance. 5 - Severe disability. Bedridden, incontinent, and requires constant nursing care and attention. 6 - Dead. Persons with a Rankin of 0-2 are considered functionally independent.|360 days post randomization|The intent-to-treat analysis sample includes all subjects who are randomized, and each subject is analyzed according to the treatment group to which they were randomly assigned. Subjects with missing mRS and mRS measured <330 days or >390 days post-randomization are assigned an unfavorable outcome (mRS>2).||participants|||Number
726027|NCT00359424|Secondary|Modified Rankin Scale (mRS) Score Dichotomized to 0-2 Versus Greater Than 2|The modified Rankin Scale (mRS) runs from 0-6 running from perfect health without symptoms to death. 0 - No symptoms at all. 1 - No significant disability. Able to carry out all usual duties and activities. 2 - Slight disability. Unable to carry out all previous activities but able to look after own affairs without assistance. 3 - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to walk unassisted and unable to attend to own bodily needs without assistance. 5 - Severe disability. Bedridden, incontinent, and requires constant nursing care and attention. 6 - Dead. Persons with a Rankin of 0-2 are considered functionally independent.|270 days|The intent-to-treat analysis sample includes all subjects who are randomized, and each subject is analyzed according to the treatment group to which they were randomly assigned. Subjects with missing mRS and mRS measured <240 days or >300 days post-randomization are assigned an unfavorable outcome (mRS>2).||participants|||Number
727605|NCT00377312|Secondary|24 Hour Urine Calcium|mg/gm creatinine|24 hours period from Day 7 to Day 8|||mg/gm creatinine||Standard Error|Mean
726028|NCT00359424|Secondary|Modified Rankin Scale (mRS) Score Dichotomized to 0-2 Versus Greater Than 2|The modified Rankin Scale (mRS) runs from 0-6 running from perfect health without symptoms to death. 0 - No symptoms at all. 1 - No significant disability. Able to carry out all usual duties and activities. 2 - Slight disability. Unable to carry out all previous activities but able to look after own affairs without assistance. 3 - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to walk unassisted and unable to attend to own bodily needs without assistance. 5 - Severe disability. Bedridden, incontinent, and requires constant nursing care and attention. 6 - Dead. Persons with a Rankin of 0-2 are considered functionally independent.|at 180 days|The intent-to-treat analysis sample includes all subjects who are randomized, and each subject is analyzed according to the treatment group to which they were randomly assigned. Subjects with missing mRS and mRS measured <150 days or >210 days post-randomization are assigned an unfavorable outcome (mRS>2).||participants|||Number
726029|NCT00359424|Secondary|Trail Making Test Part B Time|The Trail Making Test is a neuropsychological test of visual attention and task switching that is thought to be sensitive to the presence of cerebral dysfunction. It is a timed test consisting of two parts where the subject is asked to draw a “trail” made by connecting numbers in sequential order (part A) and then in part B the combination of numbers and letters. Scoring is calculated separately for Parts A and B but both scores are provided as the minutes and seconds it takes for the subject to complete each part. Normally, the entire test (A and B) can be completed in 5 to 10 minutes.|at 90 days post randomization|Participants were excluded if the Trail Making Test was not assessed or if they failed to complete Part B.||seconds||Standard Deviation|Mean
726030|NCT00359424|Secondary|Trail Making Test Part A Time|The Trail Making Test is a neuropsychological test of visual attention and task switching that is thought to be sensitive to the presence of cerebral dysfunction. It is a timed test consisting of two parts where the subject is asked to draw a “trail” made by connecting numbers in sequential order (part A) and then in part B the combination of numbers and letters. Scoring is calculated separately for Parts A and B but both scores are provided as the minutes and seconds it takes for the subject to complete each part. Normally, the entire test (A and B) can be completed in 5 to 10 minutes.|90 days post randomization|Participants were excluded if the Trail Making Test was not assessed or if they failed to complete Part A.||seconds||Standard Deviation|Mean
726031|NCT00359424|Secondary|Barthel Index (BI) Dichotomized 0-90 Versus 95-100|The Barthel Index (BI)is an ordinal scale used to measure a subject's performance in activities of daily living (ADL) in ten variables- feeding, transfer (bed to chair), grooming, toilet use, bathing, mobility on a level surface, stair use, dressing, bowels and bladder. It is an assessment of independence in ADL and is scored in increments of 5 points. The lowest possible score on the index is 0 which implies total dependence on others for ADL and the highest total score is 100 which indicate full independent in ADL. A higher score is associated with a greater likelihood of being able to live at home with a degree of independence.|at 90 days post randomization|The intent-to-treat analysis sample includes all subjects who are randomized, and each subject is analyzed according to the treatment group to which they were randomly assigned. Subjects with missing BI and BI measured <60 days or >120 days post-randomization are assigned an unfavorable outcome (BI 0-90).||participants|||Number
726032|NCT00359424|Secondary|National Institutes of Health Stroke Scale Score (NIHSS) Dichotomized 0-1 Versus 2 or Greater.|The National Institutes of Health Stroke Scale (NIHSS), a serial measure of neurologic deficit, is a 42-point scale that quantifies neurologic deficits in 11 categories, with 0 indicating normal function without neurologic deficit and higher scores indicating greater severity of deficit.|at 90 days post randomization|The intent-to-treat analysis sample includes all subjects who are randomized, and each subject is analyzed according to the treatment group to which they were randomly assigned. Subjects with missing NIHSS and NIHSS measured <60 days or >120 days post-randomization are assigned an unfavorable outcome (NIHSS score>1).||participants|||Number
726033|NCT00359424|Secondary|National Institutes of Health Stroke Scale Score (NIHSS) >> Dichotomized 0-1 Versus 2 or Greater.|"The National Institutes of Health Stroke Scale (NIHSS), a serial measure of neurologic deficit, is a 42-point scale that >> quantifies neurologic deficits in 11 categories, with 0 indicating normal function without neurologic deficit and higher
>> scores indicating greater severity of deficit."|at 24 hours post randomization|The intent-to-treat analysis sample includes all subjects who are randomized, and each subject is analyzed according to the treatment group to which they were randomly assigned. Subjects with missing NIHSS and NIHSS measured <18 hours or >30 hours post-randomization are assigned an unfavorable outcome (NIHSS score>1).||participants|||Number
726034|NCT00359424|Secondary|Asymptomatic Intracranial Hemorrhage|Asymptomatic intracranial hemorrhage is defined as an intracranial hemorrhage without evidence of decline in neurological status or new or worsening neurologic symptoms in the judgment of the clinical investigator. These events are identified via Adverse Event CRF submitted by the site.|within 30 hours post IV rt-PA|The intent-to-treat analysis sample includes all subjects who are randomized, and each subject is analyzed according to the treatment group to which they were randomly assigned.||participants|||Number
726035|NCT00359424|Secondary|Incidence of Parenchymal Type II (PH2) Hematomas|a dense intracerebral hematoma involving more than 30% of the infarcted area with substantial space-occupying effect or any hemorrhagic area outside the infarcted area, determined via central read of the submitted CT scans.|within 30 hours post IV rt-PA|Subjects were excluded if a post-baseline CT scan was not obtained within 30 hours of randomization (i.e., participants who died, had care withdrawn at the request of the family, or underwent imaging after the 30-hour window).||participants|||Number
726036|NCT00359424|Primary|Symptomatic Intracranial Hemorrhage|Symptomatic Intracranial Hemorrhage- Symptomatic ICH is defined as an intracranial hemorrhage temporally related to a decline in neurological status as well as new or worsening neurologic symptoms in the judgment of the clinical investigator and which may warrant medical intervention. These events are identified via Adverse Event CRF submitted by the site|within the first 30 hours post IV rt-PA|The intent-to-treat analysis sample includes all subjects who are randomized, and each subject is analyzed according to the treatment group to which they were randomly assigned.||participants|||Number
726037|NCT00359424|Primary|Death Due to Any Cause||within 90 days post randomization|The intent-to-treat analysis includes all subjects who were randomized, and each subject analyzed according to the treatment group to which they were randomly assigned. Subjects who ended the study prior to 90 days post- randomization for a reason other than death (LTFU etc) (n=8 in group two; n=2 in group one) are assumed to be alive||participants|||Number
726038|NCT00359424|Primary|Modified Rankin Scale (mRS) Score Dichotomized to 0-2 Versus Greater Than 2.|The modified Rankin Scale (mRS) runs from 0-6 running from perfect health without symptoms to death. 0 - No symptoms at all. 1 - No significant disability. Able to carry out all usual duties and activities. 2 - Slight disability. Unable to carry out all previous activities but able to look after own affairs without assistance. 3 - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to walk unassisted and unable to attend to own bodily needs without assistance. 5 - Severe disability. Bedridden, incontinent, and requires constant nursing care and attention. 6 - Dead. Persons with a Rankin of 0-2 are considered functionally independent.|at 90 days post randomization|The primary analysis was conducted according to intention to treat. All subjects were analyzed in the treatment group to which they were randomized. Subjects with missing mRS (n=9 in group two; n=4 in group one) or mRS assessed <60 days or >120 days post-randomization (n=10 in group two; n=4 in group one) are assigned an unfavorable outcome(mRS >2)||participants|||Number
726039|NCT00359619|Secondary|Number of Subjects With Pregnancy Outcomes.|Pregnancy outcomes were normal infant, abnormal infant/congenital anomaly, spontaneous abortion and elective termination.|From Month 0 to Month 48|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||subjects|||Number
726040|NCT00359619|Secondary|Number of Subjects With Pregnancy Outcomes.|Pregnancy outcomes were healthy baby, abnormal infant/congenital anomaly, spontaneous abortion and elective abortion.|From Month 0 to Month 36|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||subjects|||Number
726041|NCT00359619|Secondary|Number of Subjects With Pregnancy Outcomes.|Pregnancy outcomes were healthy baby, spontaneous abortion, elective abortion and ongoing pregnancy.|From Month 0 to Month 24|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||subjects|||Number
726042|NCT00359619|Secondary|Number of Subjects With Pregnancy Outcomes.|Pregnancy outcomes were healthy baby, spontaneous abortion and elective abortion.|From Month 0 to Month 18|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||subjects|||Number
726043|NCT00359619|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity, or are a congenital anomaly/birth defect in the offspring of a study subject. Any = Occurrence of any symptom regardless of intensity grade.|From Month 0 to Months 18, 24, 36 and 48|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||subjects|||Number
726044|NCT00359619|Secondary|Number of Subjects With at Least One Medically Significant Condition (MAEs).|MAEs were defined as adverse events (AEs) prompting emergency room or physician visits that were not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities, and injury. At least one MAE = At least one medically significant AE experienced (regardless of the MedDRA Preferred Term).|From Month 0 to Months 18, 24, 36 and 48|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||subjects|||Number
726045|NCT00359619|Secondary|Number of Subjects With at Least One New Onset of Chronic Disease (NOCDs)|NOCDs include conditions such as diabetes, autoimmune disease, asthma, allergies etc. At least one NOCD = At least one NOCD experienced (regardless of the Medical Dictionary for Regulatory Activities [MedDRA] Preferred Term)|From Month 0 to Months 18, 24, 36 and 48|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||subjects|||Number
726046|NCT00359619|Secondary|Geometric Mean Titers (GMTs) for Human Papillomavirus-45 (HPV-45) Antibodies.|Antibody titers were expressed as GMTs. The reference cut-off value was ≥ 59 EL.U/mL.|At Months 18, 24, 36 and 48.|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||EL.U/mL||95% Confidence Interval|Geometric Mean
726047|NCT00359619|Secondary|Number of Seroconverted Subjects Against Human Papillomavirus-45 (HPV-45) Antibodies.|Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. Seronegative subjects are subjects who had an antibody concentration below cut-off value. The assessed cut-off value was 59 EL.U/mL.|At Months 18, 24, 36 and 48.|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||subjects|||Number
726048|NCT00359619|Secondary|Geometric Mean Titers (GMTs) for Human Papillomavirus-31 (HPV-31) Antibodies.|Antibody titers were expressed as GMTs. The reference cut-off value was ≥ 59 EL.U/mL.|At Months 18, 24, 36 and 48.|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||EL.U/mL.||95% Confidence Interval|Geometric Mean
726049|NCT00359619|Secondary|Number of Seroconverted Subjects Against Human Papillomavirus-31 (HPV-31) Antibodies.|Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. Seronegative subjects are subjects who had an antibody concentration below cut-off value. The assessed cut-off value was 59 EL.U/mL.|At Months 18, 24, 36 and 48.|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||subjects|||Number
726096|NCT00359788|Secondary|Evening PEFR at Week 7|Weekly means for evening PEFR|Week 7|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters/minute||Standard Error|Least Squares Mean
726050|NCT00359619|Primary|Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies|Antibody titers were expressed as GMTs. The reference cut-off value was greater than or equal to (≥) 7 EL.U/mL.|At Months 18, 24, 36 and 48.|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Titers||95% Confidence Interval|Geometric Mean
726051|NCT00359619|Primary|Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies.|Antibody titers were expressed as GMTs. The reference cut-off value was ≥ 7 EL.U/mL.|At Months 18, 24, 36 and 48.|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||EL.U/mL||95% Confidence Interval|Geometric Mean
726052|NCT00359619|Primary|Number of Seroconverted Subjects Against Human Papillomavirus-18 (HPV-18) Antibodies.|Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. Seronegative subjects are subjects who had an antibody concentration below cut-off value. The assessed cut-off value was 7 EL.U/mL.|At Months 18, 24, 36 and 48.|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||subjects|||Number
726053|NCT00359619|Primary|Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies|Antibody titers were expressed as GMTs. The reference cut-off value was greater than or equal to (≥) 8 EL.U/mL.|At Months 18, 24, 36 and 48.|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Titers||95% Confidence Interval|Geometric Mean
726054|NCT00359619|Primary|Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies.|Antibody titers were expressed as GMTs. The reference cut-off value was greater than or equal to (≥) 8 EL.U/mL.|At Months 18, 24, 36 and 48.|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||EL.U/mL||95% Confidence Interval|Geometric Mean
726055|NCT00359619|Primary|Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) Antibodies.|Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. Seronegative subjects are subjects who had an antibody concentration below cut-off value. The assessed cut-off value was 8 ELISA units per milliliter (EL.U/mL).|At Months 18, 24, 36 and 48.|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||subjects|||Number
726056|NCT00359632|Secondary|Percentage of Participants by Clinical Outcome of Infection at End of Study|Clinical response was evaluated at the End of Study visit (30 days after last dose) as Cure, Improvement, Failure, Unknown or Other. Clinical response was based primarily on the global assessment of the clinical presentation of the subject made by the investigator at that evaluation timepoint. The clinical response classifications were defined as follows. Cure: Resolution of the clinical signs and symptoms of infection, when compared to Baseline. No additional antimicrobial treatment is required for the disease under study. Improvement: Improvement in 2 or more, but not all, of the clinical signs and symptoms of infection, when compared with Baseline. No additional antimicrobial treatment is required for the disease under study. Failure: Persistence or progression of Baseline clinical signs and symptoms of infection, or development of new clinical findings consistent with active infection. Unknown: Inability to assess clinical response.|At End of Study visit|||Percentage of Participants|||Number
726057|NCT00359632|Primary|Percentage of Participants With an Adverse Event||Through and including 28 calendar days after the last administration of the investigational product|||Percentage of Participants|||Number
726060|NCT00359762|Secondary|Hypoglycemia Rate Per Year in Period III|All hypoglycemia episodes were taken into account. Severe hypoglycemia: event requiring assistance of another person to administer carbohydrate, glucagons, or other resuscitative actions; Documented symptomatic hypoglycemia: event with typical symptoms accompanied by a measured plasma glucose concentration <=70 mg/dL; Asymptomatic hypoglycemia: event not accompanied by typical symptoms but with a measured plasma glucose concentration <=70 mg/dL; Probable symptomatic hypoglycemia: event with symptoms not accompanied by a plasma glucose determination.|Start of Period III to end of study|Extension ITT Safety Population: Extension enrolled patients receiving at least one dose of study medication in Study Period III.||events per subject-year||Standard Deviation|Mean
726061|NCT00359762|Secondary|Change in HbA1c From Baseline to Year 2 for Patients Not Randomized at Entry in Period III|Change in HbA1c from baseline to Year 2.|Baseline in Period III, Year 2 in Period III|Extension ITT Efficacy population. The analysis included patients not randomized at entry in study period III. Missing data at Year 2 was not imputed.||percentage of total hemoglobin||Standard Deviation|Mean
726062|NCT00359762|Secondary|Change in HbA1c From Baseline to Year 2 for Patients Randomized at Entry in Period III|Change in HbA1c from baseline to Year 2.|Baseline in Period III, Year 2 in Period III|Extension ITT Efficacy Population: Extension enrolled patients with at least one post-baseline measurement of HbA1c in Study Period III. The analysis included patients randomized at entry in study period III. Missing data at Year 2 was not imputed.||percentage of total hemoglobin||Standard Error|Least Squares Mean
726063|NCT00359762|Secondary|Hypoglycemia Rate Per Year|All hypoglycemia episodes were taken into account. Severe hypoglycemia: event requiring assistance of another person to administer carbohydrate, glucagons, or other resuscitative actions; Documented symptomatic hypoglycemia: event with typical symptoms accompanied by a measured plasma glucose concentration <=70 mg/dL; Asymptomatic hypoglycemia: event not accompanied by typical symptoms but with a measured plasma glucose concentration <=70 mg/dL; Probable symptomatic hypoglycemia: event with symptoms not accompanied by a plasma glucose determination.|Baseline to end of Period II (up to 4.5 years)|ITT Safety Population.||events per subject-year||Standard Error|Least Squares Mean
726064|NCT00359762|Secondary|High-density Lipoprotein (HDL) Cholesterol at Year 3|HDL Cholesterol at Year 3.|Year 3 in Period II|ITT Safety Population. The analysis included only time points up to that week where at least 25% of the originally enrolled population was still in the study. Missing data at Year 3 was not imputed.||mmol/L||Standard Error|Least Squares Mean
726065|NCT00359762|Secondary|Total Cholesterol at Year 3|Total Cholesterol at Year 3.|Year 3 in Period II|ITT Safety Population. The analysis included only time points up to that week where at least 25% of the originally enrolled population was still in the study. Missing data at Year 3 was not imputed.||mmol/L||Standard Error|Least Squares Mean
726066|NCT00359762|Secondary|Triglycerides at Year 3|Triglycerides at Year 3.|Year 3 in Period II|ITT Safety Population. The analysis included only time points up to that week where at least 25% of the originally enrolled population was still in the study. Missing data at Year 3 was not imputed.||mmol/L||Standard Error|Least Squares Mean
726067|NCT00359762|Secondary|Heart Rate at Year 3|Heart rate at Year 3.|Year 3 in Period II|ITT Safety Population. The analysis included only time points up to that week where at least 25% of the originally enrolled population was still in the study. Missing data at Year 3 was not imputed.||beats per minute||Standard Error|Least Squares Mean
726068|NCT00359762|Secondary|Diastolic Blood Pressure at Year 3|Diastolic Blood pressure at Year 3.|Year 3 in Period II|ITT Safety Population. The analysis included only time points up to that week where at least 25% of the originally enrolled population was still in the study. Missing data at Year 3 was not imputed.||mmHg||Standard Error|Least Squares Mean
726069|NCT00359762|Secondary|Systolic Blood Pressure at Year 3|Systolic Blood pressure at Year 3.|Year 3 in Period II|ITT Safety Population. The analysis included only time points up to that week where at least 25% of the originally enrolled population was still in the study. Missing data at Year 3 was not imputed.||mmHg||Standard Error|Least Squares Mean
726070|NCT00359762|Secondary|Change in Body Weight From Baseline to Year 3|Change in Body weight from baseline to Year 3.|Baseline, Year 3 in Period II|ITT Safety Population: Enrolled patients receiving at least one dose of study medication in Study Period II with patients analyzed according to treatment actually received. The analysis included only time points up to that week where at least 25% of the originally enrolled population was still in the study. Missing data at Year 3 was not imputed.||kg||Standard Error|Least Squares Mean
726071|NCT00359762|Secondary|Change in Postprandial (2 Hours) Plasma Glucose From Baseline to Endpoint|Change from baseline in postprandial (2 hours) plasma glucose to endpoint.|Baseline, end of Period II (up to 4.5 years)|ITT Efficacy Population. Missing data at endpoint was imputed using LOCF approach.||mmol/L||Standard Error|Least Squares Mean
726072|NCT00359762|Secondary|Postprandial (2 Hours) Plasma Glucose at Year 3|Postprandial (2 hours) plasma glucose at Year 3.|Year 3 in Period II|ITT Efficacy Population. The analysis included only time points up to that week where at least 25% of the originally enrolled population was still in the study. Missing data at Year 3 was not imputed.||mmol/L||Standard Error|Least Squares Mean
726073|NCT00359762|Secondary|Change in Fasting Plasma Glucose From Baseline to Endpoint|Change in fasting plasma glucose from baseline to endpoint.|Baseline, end of Period II (up to 4.5 years)|ITT Efficacy Population. Missing data at endpoint was imputed using LOCF approach.||mmol/L||Standard Error|Least Squares Mean
726074|NCT00359762|Secondary|Fasting Plasma Glucose at Year 3|Fasting plasma glucose at Year 3.|Year 3 in Period II|ITT Efficacy Population. The analysis included only time points up to that week where at least 25% of the originally enrolled population was still in the study. Missing data at Year 3 was not imputed.||mmol/L||Standard Error|Least Squares Mean
726075|NCT00359762|Secondary|Change in HbA1c From Baseline to Endpoint|Change in HbA1c from baseline to endpoint. Endpoint for HbA1c was defined as the HbA1c measured at the treatment failure for patients reaching primary endpoint and was the last observation in study period II for other patients (either followed until the end of the study period II or discontinuing the study).|Baseline, end of Period II (up to 4.5 years)|ITT Efficacy Population.||percentage of total hemoglobin||Standard Error|Least Squares Mean
726076|NCT00359762|Secondary|Change in HbA1c From Baseline to Year 3|Change in HbA1c from baseline to Year 3.|Baseline, Year 3 in Period II|ITT Efficacy Population. The analysis included only time points up to that week where at least 25% of the originally enrolled population was still in the study. Missing data at Year 3 was not imputed.||percentage of total hemoglobin||Standard Error|Least Squares Mean
726077|NCT00359762|Secondary|Change in Disposition Index From Baseline to Endpoint|Change in disposition index from baseline to endpoint.|Baseline, end of Period II (up to 4.5 years)|ITT Efficacy Population. Missing data at endpoint was imputed using LOCF approach.||ratio||Standard Error|Least Squares Mean
726078|NCT00359762|Secondary|Disposition Index at Year 3|Disposition Index at Year 3. Disposition index was calculated as (DI30/DG30 ratio)/(HOMA index for insulin resistance (HOMA-IR)); where HOMA-IR=(fasting insulin (measured in pmol/L) x fasting glucose (measured in mmol/L))/(22.5 x 7.175).|Year 3 in Period II|ITT Efficacy Population. The analysis included only time points up to that week where at least 25% of the originally enrolled population was still in the study. Missing data at Year 3 was not imputed.||ratio||Standard Error|Least Squares Mean
726079|NCT00359762|Secondary|Change in DI30/DG30 Ratio From Baseline to Endpoint|Change in DI30/DG30 ratio from baseline to endpoint.|Baseline, end of Period II (up to 4.5 years)|ITT Efficacy Population. Missing data at endpoint was imputed using LOCF approach.||ratio||Standard Error|Least Squares Mean
726097|NCT00359788|Secondary|Evening PEFR at Week 6|Weekly means for evening PEFR|Week 6|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters/minute||Standard Error|Least Squares Mean
726245|NCT00360269|Secondary|Self-reported Longitudinal Use|Participants' self-report of mean frequency of use of marijuana from baseline through week 12 visit of the study was assessed using a Time-Line Follow-Back.|12 weeks|||Percentage of days used||Standard Deviation|Mean
726080|NCT00359762|Secondary|Ratio of the 30 Minute Increment in Plasma Insulin Concentration and the 30 Minute Increment in Plasma Glucose During the Oral Glucose Tolerance Test (DI30/DG30 Ratio) at Year 3|DI30/DG30 at Year 3. DI30/DG30 ratio was calculated as (30 minute post prandial insulin - fasting insulin) (measured in pmol/L)/(30 minute post prandial glucose - fasting glucose) (measured in mmol/L).|Year 3 in Period II|ITT Efficacy Population. The analysis included only time points up to that week where at least 25% of the originally enrolled population was still in the study. Missing data at Year 3 was not imputed.||ratio||Standard Error|Least Squares Mean
726081|NCT00359762|Secondary|Change in Fasting Proinsulin/Insulin Ratio From Baseline to Endpoint.|Change in fasting proinsulin (measured in pmol/L)/insulin (measured in pmol/L) ratio from baseline to endpoint.|Baseline, end of Period II (up to 4.5 years)|ITT Efficacy Population. Missing data at endpoint was imputed using LOCF approach.||ratio||Standard Error|Least Squares Mean
726082|NCT00359762|Secondary|Fasting Proinsulin/Insulin Ratio at Year 3|Fasting proinsulin (measured in pmol/L)/insulin (measured in pmol/L) ratio at Year 3.|Year 3 in Period II|ITT Efficacy Population. The analysis included only time points up to that week where at least 25% of the originally enrolled population was still in the study. Missing data at Year 3 was not imputed.||ratio||Standard Error|Least Squares Mean
726083|NCT00359762|Secondary|Change in HOMA-B From Baseline to Endpoint|Change in HOMA-B from baseline to endpoint.|Baseline, end of Period II (up to 4.5 years)|ITT Efficacy Population. Missing data at endpoint was imputed using last observation carried forward (LOCF) approach.||ratio||Standard Error|Least Squares Mean
726084|NCT00359762|Secondary|Homeostasis Model Assessment of Beta-cell Function (HOMA-B) at Year 3|HOMA-B at Year 3. HOMA-B is an index of beta-cell function and was calculated as: HOMA-B = (20 x fasting insulin (measured in pmol/L))/((fasting glucose (measured in mmol/L) - 3.5) x 7.175).|Year 3 in Period II|ITT Efficacy Population. The analysis included only time points up to that week where at least 25% of the originally enrolled population was still in the study. Missing data at Year 3 was not imputed.||ratio||Standard Error|Least Squares Mean
726085|NCT00359762|Primary|Time to Treatment Failure|Treatment failure is defined as one of the following:1. HbA1c exceeding 9% at any visit after the initial 3 months of treatment (i.e., earliest at Month 6), on the maximally tolerated dose of antidiabetic agents. 2. HbA1c exceeding 7% at 2 consecutive visits 3 months apart, after the initial 6 months of treatment (i.e., earliest at Month 9), on the maximally tolerated dose of antidiabetic agents.|Baseline to end of Period II (up to 4.5 years)|ITT Efficacy Population.||week||95% Confidence Interval|Median
726086|NCT00359762|Primary|Number of Patients With Treatment Failure|Treatment failure is defined as one of the following:1. HbA1c exceeding 9% at any visit after the initial 3 months of treatment (i.e., earliest at Month 6), on the maximally tolerated dose of antidiabetic agents. 2. HbA1c exceeding 7% at 2 consecutive visits 3 months apart, after the initial 6 months of treatment (i.e., earliest at Month 9), on the maximally tolerated dose of antidiabetic agents.|Baseline to end of Period II (up to 4.5 years)|ITT Efficacy Population: Enrolled patients with a baseline and at least one post-baseline measurement of HbA1c in Study Period II (including only Study Period II); patients analyzed according to treatment as randomized.||number of patients|||Number
726087|NCT00359788|Secondary|Physician Global Evaluation|The Physician Global Evaluation reflected the physician's opinion of the patients overall condition with respect to COPD. The scale responses were: Poor (1,2). Fair (3,4), Good (5,6) and Excellent (7,8).|Week 12|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Units on a scale||Standard Error|Least Squares Mean
726088|NCT00359788|Secondary|Physician Global Evaluation|The Physician Global Evaluation reflected the physician's opinion of the patients overall condition with respect to COPD. The scale responses were: Poor (1,2). Fair (3,4), Good (5,6) and Excellent (7,8).|Week 6|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Units on a scale||Standard Error|Least Squares Mean
726089|NCT00359788|Secondary|Patient Global Evaluation|The Patient Global Evaluation reflected the patient's opinion of their overall condition with respect to COPD. The scale responses were: Poor (1,2). Fair (3,4), Good (5,6) and Excellent (7,8).|Week 12|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Units on a scale||Standard Error|Least Squares Mean
726090|NCT00359788|Secondary|Patient Global Evaluation|The Patient Global Evaluation reflected the patient's opinion of their overall condition with respect to chronic obstructive pulmonary disease (COPD). The scale responses were: Poor (1,2). Fair (3,4), Good (5,6) and Excellent (7,8)|Week 6|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Units on a scale||Standard Error|Least Squares Mean
726091|NCT00359788|Secondary|Evening PEFR at Week 12|Weekly means for evening PEFR|Week 12|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters/minute||Standard Error|Least Squares Mean
726092|NCT00359788|Secondary|Evening PEFR at Week 11|Weekly means for evening PEFR|Week 11|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters/minute||Standard Error|Least Squares Mean
726093|NCT00359788|Secondary|Evening PEFR at Week 10|Weekly means for evening PEFR|Week 10|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters/minute||Standard Error|Least Squares Mean
726094|NCT00359788|Secondary|Evening PEFR at Week 9|Weekly means for evening PEFR|Week 9|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters/minute||Standard Error|Least Squares Mean
726095|NCT00359788|Secondary|Evening PEFR at Week 8|Weekly means for evening PEFR|Week 8|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters/minute||Standard Error|Least Squares Mean
727606|NCT00377312|Secondary|Fractional Excretion of Calcium|% = (S Creatinine X U Calcium)/(S Calcium X U Creatinine)|baseline and daily|||% of excretion||Standard Error|Mean
726098|NCT00359788|Secondary|Evening PEFR at Week 5|Weekly means for evening PEFR|Week 5|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters/minute||Standard Error|Least Squares Mean
726099|NCT00359788|Secondary|Evening PEFR at Week 4|Weekly means for evening PEFR|Week 4|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters/minute||Standard Error|Least Squares Mean
726100|NCT00359788|Secondary|Evening PEFR at Week 3|Weekly means for evening PEFR|Week 3|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters/minute||Standard Error|Least Squares Mean
726101|NCT00359788|Secondary|Evening PEFR at Week 2|Weekly means for evening PEFR|Week 2|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters/minute||Standard Error|Least Squares Mean
726102|NCT00359788|Secondary|Evening PEFR at Week 1|Weekly means for evening PEFR|Week 1|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters/minute||Standard Error|Least Squares Mean
726103|NCT00359788|Secondary|Morning PEFR at Week 12|Weekly means for morning PEFR|Week 12|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters/minute||Standard Error|Least Squares Mean
726104|NCT00359788|Secondary|Morning PEFR at Week 11|Weekly means for morning PEFR|Week 11|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters/minute||Standard Error|Least Squares Mean
726105|NCT00359788|Secondary|Morning PEFR at Week 10|Weekly means for morning PEFR|Week 10|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters/minute||Standard Error|Least Squares Mean
726106|NCT00359788|Secondary|Morning PEFR at Week 9|Weekly means for morning PEFR|Week 9|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters/minute||Standard Error|Least Squares Mean
726107|NCT00359788|Secondary|Morning PEFR at Week 8|Weekly means for morning PEFR|Week 8|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters/minute||Standard Error|Least Squares Mean
726108|NCT00359788|Secondary|Morning PEFR at Week 7|Weekly means for morning PEFR|Week 7|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters/minute||Standard Error|Least Squares Mean
726109|NCT00359788|Secondary|Morning PEFR at Week 6|Weekly means for morning PEFR|Week 6|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters/minute||Standard Error|Least Squares Mean
726110|NCT00359788|Secondary|Morning PEFR at Week 5|Weekly means for morning PEFR|Week 5|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters/minute||Standard Error|Least Squares Mean
726111|NCT00359788|Secondary|Morning PEFR at Week 4|Weekly means for morning PEFR|Week 4|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters/minute||Standard Error|Least Squares Mean
726112|NCT00359788|Secondary|Morning PEFR at Week 3|Weekly means for morning PEFR|Week 3|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters/minute||Standard Error|Least Squares Mean
726113|NCT00359788|Secondary|Morning PEFR at Week 2|Weekly means for morning PEFR|Week 2|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters/minute||Standard Error|Least Squares Mean
726114|NCT00359788|Secondary|Morning Peak Expiratory Flow Rate (PEFR) at Week 1||Week 1|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters/minute||Standard Error|Least Squares Mean
726115|NCT00359788|Secondary|Night Time Albuterol Use During Week 12|Puffs of rescue albuterol used during the night in week 12|Week 12|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Puffs per night||Standard Error|Least Squares Mean
726116|NCT00359788|Secondary|Night Time Albuterol Use During Week 11|Puffs of rescue albuterol used during the night in week 11|Week 11|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Puffs per night||Standard Error|Least Squares Mean
726117|NCT00359788|Secondary|Night Time Albuterol Use During Week 10|Puffs of rescue albuterol used during the night in week 10|Week 10|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Puffs per night||Standard Error|Least Squares Mean
726118|NCT00359788|Secondary|Night Time Albuterol Use During Week 9|Puffs of rescue albuterol used during the night in week 9|Week 9|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Puffs per night||Standard Error|Least Squares Mean
726243|NCT00360269|Secondary|Urine Drug Screens|Participants submitted a urine sample weekly. Percentage of marijuana positive urine samples were calculated per group.|12 weeks|||Percentage of positive UDS|||Number
726119|NCT00359788|Secondary|Night Time Albuterol Use During Week 8|Puffs of rescue albuterol used during the night in week 8|Week 8|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Puffs per night||Standard Error|Least Squares Mean
726120|NCT00359788|Secondary|Night Time Albuterol Use During Week 7|Puffs of rescue albuterol used during the night in week 7|Week 7|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Puffs per night||Standard Error|Least Squares Mean
726121|NCT00359788|Secondary|Night Time Albuterol Use During Week 6|Puffs of rescue albuterol used during the night in week 6|Week 6|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Puffs per night||Standard Error|Least Squares Mean
726122|NCT00359788|Secondary|Night Time Albuterol Use During Week 5|Puffs of rescue albuterol used during the night in week 5|Week 5|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Puffs per night||Standard Error|Least Squares Mean
726123|NCT00359788|Secondary|Night Time Albuterol Use During Week 4|Puffs of rescue albuterol used during the night in week 4|Week 4|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Puffs per night||Standard Error|Least Squares Mean
726124|NCT00359788|Secondary|Night Time Albuterol Use During Week 3|Puffs of rescue albuterol used during the night in week 3|Week 3|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Puffs per night||Standard Error|Least Squares Mean
726125|NCT00359788|Secondary|Night Time Albuterol Use During Week 2|Puffs of rescue albuterol used during the night in week 2|Week 2|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Puffs per night||Standard Error|Least Squares Mean
726126|NCT00359788|Secondary|Night Time Albuterol Use During Week 1||Week 1|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Puffs per night||Standard Error|Least Squares Mean
726127|NCT00359788|Secondary|Day Time Albuterol Use During Week 12|Puffs of rescue albuterol used during the day in week 12|Week 12|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Puffs per day||Standard Error|Least Squares Mean
726128|NCT00359788|Secondary|Day Time Albuterol Use During Week 11|Puffs of rescue albuterol used during the day in week 11|Week 11|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Puffs per day||Standard Error|Least Squares Mean
726129|NCT00359788|Secondary|Day Time Albuterol Use During Week 10|Puffs of rescue albuterol used during the day in week 10|Week 10|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Puffs per day||Standard Error|Least Squares Mean
726130|NCT00359788|Secondary|Day Time Albuterol Use During Week 9|Puffs of rescue albuterol used during the day in week 9|Week 9|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Puffs per day||Standard Error|Least Squares Mean
726131|NCT00359788|Secondary|Day Time Albuterol Use During Week 8|Puffs of rescue albuterol used during the day in week 8|Week 8|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Puffs per day||Standard Error|Least Squares Mean
726132|NCT00359788|Secondary|Day Time Albuterol Use During Week 7|Puffs of rescue albuterol used during the day in week 7|Week 7|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Puffs per day||Standard Error|Least Squares Mean
726133|NCT00359788|Secondary|Day Time Albuterol Use During Week 6|Puffs of rescue albuterol used during the day in week 6|Week 6|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Puffs per day||Standard Error|Least Squares Mean
726134|NCT00359788|Secondary|Day Time Albuterol Use During Week 5|Puffs of rescue albuterol used during the day in week 5|Week 5|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Puffs per day||Standard Error|Least Squares Mean
726135|NCT00359788|Secondary|Day Time Albuterol Use During Week 4|Puffs of rescue albuterol used during the day in week 4|Week 4|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Puffs per day||Standard Error|Least Squares Mean
726136|NCT00359788|Secondary|Day Time Albuterol Use During Week 3|Puffs of rescue albuterol used during the day in week 3|Week 3|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Puffs per day||Standard Error|Least Squares Mean
726137|NCT00359788|Secondary|Day Time Albuterol Use During Week 2|Puffs of rescue albuterol used during the day in week 2|Week 2|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Puffs per day||Standard Error|Least Squares Mean
726138|NCT00359788|Secondary|Day Time Albuterol Use During Week 1|Puffs of rescue albuterol used during the day in week 1|Week 1|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Puffs per day||Standard Error|Least Squares Mean
726139|NCT00359788|Secondary|FVC at 6 Hours at Week 12||6 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
726140|NCT00359788|Secondary|FVC at 4 Hours at Week 12||4 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
726141|NCT00359788|Secondary|FVC at 3 Hours at Week 12||3 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
726142|NCT00359788|Secondary|FVC at 2 Hours at Week 12||2 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
726143|NCT00359788|Secondary|FVC at 1 Hour at Week 12||1 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
726144|NCT00359788|Secondary|FVC at 30 Minutes at Week 12||30 minutes|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
726145|NCT00359788|Secondary|FVC at 15 Minutes at Week 12||15 minutes|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
726146|NCT00359788|Secondary|FVC at -10 Minutes at Week 12||10 minutes before dosing|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
726147|NCT00359788|Secondary|FVC at 6 Hours at Week 6||6 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
726148|NCT00359788|Secondary|FVC at 4 Hours at Week 6||4 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
726149|NCT00359788|Secondary|FVC at 3 Hours at Week 6||3 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
726150|NCT00359788|Secondary|FVC at 2 Hours at Week 6||2 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
726151|NCT00359788|Secondary|FVC at 1 Hour at Week 6||1 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
726152|NCT00359788|Secondary|FVC at 30 Minutes at Week 6||30 minutes|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
726153|NCT00359788|Secondary|FVC at 15 Minutes at Week 6||15 minutes|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
726154|NCT00359788|Secondary|FVC at -10 Minutes at Week 6||10 minutes before dosing|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
726155|NCT00359788|Secondary|FVC at 6 Hours on Day 1||6 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
726156|NCT00359788|Secondary|FVC at 4 Hours on Day 1||4 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
726157|NCT00359788|Secondary|FVC at 3 Hours on Day 1||3 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
726158|NCT00359788|Secondary|FVC at 2 Hours on Day 1||2 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
726159|NCT00359788|Secondary|FVC at 1 Hour on Day 1||1 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
726160|NCT00359788|Secondary|FVC at 30 Minutes on Day 1||30 minutes|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
726161|NCT00359788|Secondary|FVC at 15 Minutes on Day 1||15 minutes|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
726162|NCT00359788|Secondary|FEV1 at 6 Hours at Week 12||6 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
726163|NCT00359788|Secondary|FEV1 at 4 Hours at Week 12||4 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
726164|NCT00359788|Secondary|FEV1 at 3 Hours at Week 12||3 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
726165|NCT00359788|Secondary|FEV1 at 2 Hours at Week 12||2 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
726166|NCT00359788|Secondary|FEV1 at 1 Hour at Week 12||1 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
726167|NCT00359788|Secondary|FEV1 at 30 Minutes at Week 12||30 minutes|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
726168|NCT00359788|Secondary|FEV1 at 15 Minutes at Week 12||15 minutes|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
726169|NCT00359788|Secondary|FEV1 at -10 Minutes at Week 12||10 minutes before dosing|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
726170|NCT00359788|Secondary|FEV1 at 6 Hours at Week 6||6 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
726171|NCT00359788|Secondary|FEV1 at 4 Hours at Week 6||4 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
726172|NCT00359788|Secondary|FEV1 at 3 Hours at Week 6||3 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
726173|NCT00359788|Secondary|FEV1 at 2 Hours at Week 6||2 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
726174|NCT00359788|Secondary|FEV1 at 1 Hour at Week 6||1 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
726175|NCT00359788|Secondary|FEV1 at 30 Minutes at Week 6||30 minutes|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
726176|NCT00359788|Secondary|FEV1 at 15 Minutes at Week 6||15 minutes|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
726177|NCT00359788|Secondary|FEV1 at -10 Minutes at Week 6||10 minutes before dosing|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
726178|NCT00359788|Secondary|FEV1 at 6 Hours on Day 1||6 hours|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
726179|NCT00359788|Secondary|FEV1 at 4 Hours on Day 1||4 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
726180|NCT00359788|Secondary|FEV1 at 3 Hours on Day 1||3 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
726181|NCT00359788|Secondary|FEV1 at 2 Hours on Day 1||2 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Least Squares Mean||Standard Error|Least Squares Mean
726182|NCT00359788|Secondary|FEV1 at 1 Hour on Day 1||1 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
726183|NCT00359788|Secondary|FEV1 at 30 Minutes on Day 1||30 minutes|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
726184|NCT00359788|Secondary|FEV1 at 15 Minutes on Day 1||15 minutes|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
726185|NCT00359788|Secondary|Change From Baseline in Peak FVC (Forced Vital Capacity) at Week 12|Peak FVC is defined as the maximum FVC observed in the first three hours after dose of study medication|Baseline and 12 Weeks|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
727607|NCT00377312|Secondary|Parathyroid Hormone (1-84)|pg/ml|baseline, daily up to Day 8 and follow-up|||pg/ml||Standard Error|Mean
726186|NCT00359788|Secondary|Change From Baseline in Peak FVC (Forced Vital Capacity) at Week 6|Peak FVC is defined as the maximum FVC observed in the first three hours after dose of study medication|baseline and 6 Weeks (after first dose)|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
726187|NCT00359788|Secondary|Change From Baseline in Peak FVC (Forced Vital Capacity) on Day 1|Peak FVC is defined as the maximum FVC observed in the first three hours after dose of study medication|Day 1|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
726188|NCT00359788|Secondary|Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) at 6 Weeks|Average hourly FVC AUC0-6 minus baseline FVC|Baseline and 6 Weeks|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
726189|NCT00359788|Secondary|Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) on Day 1|Average hourly FVC AUC0-6 minus baseline FVC|Day 1|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
726190|NCT00359788|Secondary|Change From Baseline in Trough FVC (Forced Vital Capacity) at 6 Weeks|Trough FVC is measured 10 minutes before drug administration|Baseline and 6 weeks|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
726191|NCT00359788|Secondary|Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) at 12 Weeks|Average hourly FVC AUC0-6 minus baseline FVC|Baseline and 12 Weeks|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
726192|NCT00359788|Secondary|Change From Baseline in Trough FVC (Forced Vital Capacity) at 12 Weeks|Trough FVC is measured 10 minutes before drug administration|Baseline and 12 weeks|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
726193|NCT00359788|Secondary|Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) at Week 12|Peak FEV1 is defined as the maximum FEV1 observed in the first three hours after dose of study medication|Baseline and 12 weeks|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
726194|NCT00359788|Secondary|Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) at Week 6|Peak FEV1 is defined as the maximum FEV1 observed in the first three hours after dose of study medication|Baseline and 6 weeks|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
726195|NCT00359788|Secondary|Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) on Day 1|Peak FEV1 is defined as the maximum FEV1 observed in the first three hours after dose of study medication|Day 1|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
726196|NCT00359788|Secondary|Change From Baseline in Average Hourly FEV1 AUC0-6 (Area Under the Curve From Zero to Six Hours) at Week 6|Average hourly FEV1 AUC0-6 minus baseline FEV1|Baseline and week 6|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
726197|NCT00359788|Secondary|Change From Baseline in Average Hourly FEV1 AUC0-6 (Area Under the Curve From Zero to Six Hours) on Day 1|Average hourly FEV1 AUC0-6 minus baseline FEV1|Day 1 (after first dose)|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
726198|NCT00359788|Secondary|Change From Baseline in Trough FEV1 (Forced Expiratory Volume in 1 Second) at 6 Weeks|Trough FEV1 is measured 10 minutes before drug administration|Baseline and 6 Weeks|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
726199|NCT00359788|Primary|Change From Baseline in Average Hourly FEV1 AUC0-6 (Area Under the Curve From Zero to Six Hours) at 12 Weeks|Average hourly FEV1 AUC0-6 minus baseline FEV1|Baseline and 12 Weeks|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
726200|NCT00359788|Primary|Change From Baseline in Trough FEV1 (Forced Expiratory Volume in 1 Second) at 12 Weeks|Trough FEV1 is measured 10 minutes before drug administration|Baseline and 12 Weeks|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
726201|NCT00359801|Primary|Time to Persistent Decline in FEV1 Exceeding 20% From Baseline|Elapsed time, in days, from the start of subject’s participation in the study to the first reading of FEV1 that is: 20% or more below the subject’s latest pre-study measurement, subsequently confirmed as a >20% decline [(baseline observed value minus visit observed value)/by baseline observed value *100], and assessed as persistent as defined by protocol process. Censoring time: elapsed time, in days, from the start of a subject’s participation in the study to latest valid FEV1 measurement for the particular analysis set of interest. Cox proportional hazards model to estimate treatment effect.|Baseline to 5 years|FAS. Due to early study termination, originally planned inferential analysis for time to event was not done.||days|||Number
726202|NCT00359801|Secondary|Change in Glycosylated Hemoglobin (HbA1c) From Baseline|Baseline HbA1c taken as the latest determination prior to beginning study participation. Change = on-study value (for measurements falling within the time window associated with a given analysis set) minus the baseline value. Linear model with terms for treatment, baseline HbA1c, time on study, and subject within treatment.|Baseline to 5 years|FAS. Due to early study termination, the originally planned inferential analysis (linear model) for change from baseline was not done.||percent|||Number
726203|NCT00359801|Secondary|Change in Glycosylated Hemoglobin (HbA1c) From Baseline|Baseline HbA1c: the latest determination prior to beginning study participation. Change from Baseline: HbA1c at observation (falling within the time window associated with a given analysis set) minus the baseline value.|Baseline, Month 6, Year 1, Year 2, Index Visit|FAS; (n) = number of subjects with analyzable data at observation for Exubera® and Non-Exubera®, respectively.||percent||Standard Deviation|Mean
726204|NCT00359801|Secondary|Time to Event for Allergic Response Serious Adverse Event (SAE) Composite, Including: SAEs of Anaphylaxis, Angioedema, Generalized Allergic Reaction, or Allergic Bronchospasm|Elapsed time, in days, from the start of a subject’s participation in the study to the date of the first event subsequently confirmed (according to protocol definition) as meeting the criteria for allergic response. Censoring time: elapsed time, in days, from the start of a subject’s participation in the study to the latest contact with the subject for the particular analysis set of interest. Cox proportional hazards model to estimate treatment effect.|Baseline to 5 years|FAS. Due to early study termination, originally planned inferential analysis for time to event was not done.||days|||Number
726205|NCT00359801|Secondary|Allergic Response Serious Adverse Event (SAE) Composite: SAEs of Anaphylaxis, Angioedema, Generalized Allergic Reaction, or Allergic Bronchospasm|Endpoint committee adjudicated the endpoint based on review of medical and hospital records, and results were classified using standard criteria. Definite or possible: anaphylaxis, angioedema/urticaria, bronchospasm or possible allergic reaction not otherwise specified (NOS); Insufficient: insufficient data.|Baseline through End of Study|FAS||events|||Number
726206|NCT00359801|Secondary|Time to Event for Cardiovascular Serious Adverse Event (SAE) Composite: SAEs of Cardiovascular Mortality, Non-fatal Myocardial Infarction, or Non-fatal Stroke|Elapsed time, in days, from the start of a subject’s participation in the study to the date of the first event subsequently confirmed (according to protocol definition) as meeting the criteria for cardiovascular SAE composite. Censoring time: elapsed time, in days, from the start of a subject’s participation in the study to the latest contact with the subject for the particular analysis set of interest. Cox proportional hazards model to estimate treatment effect.|Baseline to 5 years|FAS. Due to early study termination, originally planned inferential analysis for time to event was not done.||days|||Number
726207|NCT00359801|Secondary|Cardiovascular SAE Composite: SAEs of Cardiovascular Mortality, Non-fatal Myocardial Infarction (MI), or Non-fatal Stroke|Endpoint committee adjudicated based on review of medical/hospital records; results classified using standard criteria. Definite: definite MI or stroke; Possible: possible MI or stroke; Other (non-MI, non-stroke): other cardiovascular event (non-MI, non-stroke); Definite or possible: either definite or possible or both; Insufficient: insufficient data; Death from cardiovascular or cerebrovascular: cardiovascular or cerebrovascular event; Definite or possible or death from cardiovascular or cerebrovascular: either definite or possible or both or cardiovascular or cerebrovascular event.|Baseline through End of Study|FAS||events|||Number
726208|NCT00359801|Primary|Supplemental Definition of Decline in Forced Expiratory Volume in One Second (FEV1): Number of Subjects|Confirmed FEV1 decline: any two consecutive declines that are >= 14 days apart. The pulmonary function test that established persistence occured >= 60 days after the initial decline. A confirmed decline: any two consecutive declines ≥ 14 days apart. The third PFT that established persistence was to occur ≥ 60 days after the initial decline. Index Visit: date the subject had his/her final scheduled spirometry was to occur within 2 months of Institutional Review Board/Ethics approval of April 2008 amendment.|Baseline, Month 6, Year 1, Year 2, Index Visit|FAS||participants|||Number
726209|NCT00359801|Secondary|Time to Event: All-cause Mortality|Time to all-cause mortality: elapsed time, in days, from the start of a subject’s participation in the study to the date of the event subsequently confirmed (according to protocol definition) as meeting the criteria for all-cause mortality. Censoring time: elapsed time, in days, from the start of a subject’s participation in the study to the latest contact with the subject for the particular analysis set of interest. Cox proportional hazards model to estimate treatment effect.|Baseline to 5 years|FAS. Due to early study termination, originally planned inferential analysis for time to event was not done.||days|||Number
726210|NCT00359801|Secondary|All-cause Mortality: Number of Deaths|Endpoint committee adjudicated the endpoint based on review of medical and hospital records, and results were classified using standard criteria (confirmation of deaths by blinded adjudicator(s) through medical records or death certificates). Patients meeting the endpoint All Cause Mortality after adjudication by the endpoint committee.|Baseline through End of Study|FAS||participants|||Number
726211|NCT00359801|Secondary|Time to Event for Pulmonary Serious Adverse Event (SAE) Composite: SAEs of Asthma, Chronic Obstructive Pulmonary Disease (COPD), Pneumonia, or Acute Bronchitis|Elapsed time, in days, from the start of a subject’s participation in the study to the date of the first report of an event subsequently confirmed (according to protocol definition) as meeting the criteria for pulmonary SAE composite. Censoring time: elapsed time, in days, from the start of a subject’s participation in the study to the latest contact with the subject for the particular analysis set of interest. Cox proportional hazards model to estimate treatment effect.|Baseline to 5 years|FAS. Due to early study termination, originally planned inferential analysis for time to event was not done.||days|||Number
726212|NCT00359801|Secondary|Pulmonary Serious Adverse Event (SAE) Composite: SAEs of Asthma, Chronic Obstructive Pulmonary Disease (COPD), Pneumonia, or Acute Bronchitis|Endpoint committee adjudicated the endpoint based on review of medical and hospital records, and results were classified using standard criteria. Definite: definite pneumonia, definite COPD, or definite asthma; possible: possible pneumonia, possible COPD, possible asthma, probable obstructive lung disease not otherwise specified or probable acute bronchitis; definite or possible: either definite or possible; insufficient: insufficient data.|Baseline through End of Study|FAS||events|||Number
726244|NCT00360269|Primary|Estimated Week 12 Self-reported Use|Participants' self-report of mean frequency of use of marijuana during week 12 of the study was assessed using a Time-Line Follow-Back.|One week (study week 12)|||Times per day||Standard Error|Mean
726213|NCT00359801|Secondary|Change From Baseline in Forced Expiratory Volume in One Second (FEV1)|Change from Baseline: mean of value of observed forced expiratory volume in the first second of forced exhalation [FEV1] in liters [L] at observation minus Baseline value. Index Visit: date subject had final scheduled spirometry; was to occur within 2 months of Institutional Review Board/Ethics approval of April 2008 amendment.|Baseline, Week 26, Week 52, Week 104, Index Visit|FAS; (n) = number of subjects with analyzable data at observation for Exubera® and Non-Exubera®, respectively.||liters||Standard Deviation|Mean
726214|NCT00359801|Primary|Number of Subjects With Decline in Forced Expiratory Volume (FEV1) Exceeding 20% From Baseline|Persistent decline in FEV1 exceeding 20% from baseline: observed decline in FEV1 exceeding 20% from baseline, 3 months after a confirmed decline (2 consecutive declines within 1 month) in FEV1 exceeding 20% from baseline. Second pulmonary function test (PFT) that confirmed decline was to occur within 14-42 days of the decline. Persistence: PFT that established persistence was to occur within 60-120 days of the confirming (2nd) decline. Index Visit: date subject had final Scheduled spirometry; was to occur within 2 months of Institutional Review Board/Ethics approval of April 2008 amendment.|Baseline, Month 6, Year 1, Year 2, Index Visit|Full Analysis Set: all randomized subjects.||participants|||Number
726215|NCT00359944|Secondary|Disability Assessment for Dementia (DAD)|"Change from baseline to week 16 of the double blind treatment in the Disability Assessment for Dementia (DAD) scores.
The DAD is administered as a clinician-assisted interview with the caregiver and was developed to assess functional abilities in ADLs in community-dwelling dementia patients. The scale consists of 40 questions assessing basic and instumental ADLs. A total score is obtained by adding the rating for each question and converting this total score out of 100. The items rated N/A are not considered for the total score. Higher scores represent less disability in activities of daily living (ADL) while lower scores indicate more dysfunction."|Baseline to 16 Weeks|||units on a scale||Standard Deviation|Mean
726216|NCT00359944|Secondary|Clinicians Interview Based Impression of Change (CIBIC)-Plus|"Clinicians Interview Based Impression of Change (CIBIC)-Plus-Plus scores at week 16 of the double blind treatment.
CIBIC-Plus is ranged between 1 and 7 (1=very much improved, 4=no change, and 7=very much worsened). We were expecting smaller value of CIBIC-Plus at the study end."|Baseline to 16 weeks|||units on a scale||Standard Deviation|Mean
726217|NCT00359944|Primary|Total Score of Alzheimer's Disease Assessment Scale - Cognition Subscale (ADAS-COG)From Best Total Score (0) to Worst Total Score (70)|Change from baseline to week 16 of the double blind treatment in the Alzheimer's Disease Assessment Scale - Cognition Subscale (ADAS-COG) total score The Alzheimer's Disease Assessment Scale if used for assessing the severity of dysfuncion and for research in patients with AD, particularly in clinical drug trials. It consists of 11 items testing orientatin, memory, word usage and recognition, receptive speech, spatial abilities, ideational praxis, ability to follow instructions, spontanious speech abilities, and comprehension. The higher the overall score (maximum 70), the more severe the dysfunction/impairment.|Baseline to 16 weeks|||units on a scale||Standard Deviation|Mean
726218|NCT00359983|Secondary|Number of Subjects With hSBA-MenY Titers Greater Than or Equal to 1:4|Results up to 5 years after the fourth dose are presented.|One year, three years, and five years after the fourth dose vaccination.|Analysis was done on the ATP cohort for persistence of each respective timepoint in all evaluable subjects who had assay results available for at least one tested antigen and who had a blood sample taken between 309 and 645 days (Year 1 data), 1039 and 1375 days (Year 3 data) and 1770 and 1882 days (Year 5 data) after administration of fourth dose.||Subjects|||Number
726219|NCT00359983|Secondary|hSBA-MenY Geometric Mean Titers (GMTs)|"Titers are given as Geometric Mean Titers as measured by human serum bactericidal assay (hSBA) and expressed as the reciprocal of the dilution resulting in 50% inhibition.
Results up to 5 years after the fourth dose are presented."|One year, three years, and five years after the fourth dose vaccination.|Analysis was done on the ATP cohort for persistence of each respective timepoint in all evaluable subjects who had assay results available for at least one tested antigen and who had a blood sample taken between 309 and 645 days (Year 1 data), 1039 and 1375 days (Year 3 data) and 1770 and 1882 days (Year 5 data) after administration of fourth dose.||Titer||95% Confidence Interval|Geometric Mean
726220|NCT00359983|Secondary|Number of Subjects With hSBA-MenC Titers Greater Than or Equal to 1:4|Results up to 5 years after the fourth dose are presented.|One year, three years, and five years after the fourth dose vaccination.|Analysis was done on the ATP cohort for persistence of each respective timepoint in all evaluable subjects who had assay results available for at least one tested antigen and who had a blood sample taken between 309 and 645 days (Year 1 data), 1039 and 1375 days (Year 3 data) and 1770 and 1882 days (Year 5 data) after administration of fourth dose.||Subjects|||Number
726221|NCT00359983|Secondary|hSBA-MenC Geometric Mean Titers (GMTs)|"Titers are given as Geometric Mean Titers as measured by human serum bactericidal assay (hSBA) and expressed as the reciprocal of the dilution resulting in 50% inhibition.
Results up to 5 years after the fourth dose are presented."|One year, three years, and five years after the fourth dose vaccination.|Analysis was done on the ATP cohort for persistence of each respective timepoint in all evaluable subjects who had assay results available for at least one tested antigen and who had a blood sample taken between 309 and 645 days (Year 1 data), 1039 and 1375 days (Year 3 data) and 1770 and 1882 days (Year 5 data) after administration of fourth dose.||Titer||95% Confidence Interval|Geometric Mean
726222|NCT00359983|Secondary|Number of Subjects With Anti-PRP Antibody Concentrations Greater Than or Equal to 1.0 Microgram Per Milliliter|Results up to 5 years after the fourth dose are presented.|One year, three years, and five years after the fourth dose vaccination.|Analysis was done on the ATP cohort for persistence of each respective timepoint in all evaluable subjects who had assay results available for at least one tested antigen and who had a blood sample taken between 309 and 645 days (Year 1 data), 1039 and 1375 days (Year 3 data) and 1770 and 1882 days (Year 5 data) after administration of fourth dose.||Subjects|||Number
726223|NCT00359983|Secondary|Anti-PRP Geometric Mean Concentrations (GMCs)|"Concentration were measured as Geometric Mean Concentrations expressed as microgram per milliliter (µg/mL).
Results up to 5 years after the fourth dose are presented."|One year, three years, and five years after the fourth dose vaccination.|Analysis was done on the ATP cohort for persistence of each respective timepoint in all evaluable subjects who had assay results available for at least one tested antigen and who had a blood sample taken between 309 and 645 days (Year 1 data), 1039 and 1375 days (Year 3 data) and 1770 and 1882 days (Year 5 data) after administration of fourth dose.||µg/mL||95% Confidence Interval|Geometric Mean
726224|NCT00359983|Primary|Number of Subjects With Neisseria Meningitidis Serogroup Y (MenY) Antibody Titers Greater Than or Equal to 1:8 as Measured by Serum Bactericidal Assay Using Human Complement (hSBA)|Results up to 5 years after the fourth dose are presented.|One year, three years, and five years after the fourth dose vaccination.|Analysis was done on the ATP cohort for persistence of each respective timepoint in all evaluable subjects who had assay results available for at least one tested antigen and who had a blood sample taken between 309 and 645 days (Year 1 data), 1039 and 1375 days (Year 3 data) and 1770 and 1882 days (Year 5 data) after administration of fourth dose.||Subjects|||Number
726225|NCT00359983|Primary|Number of Subjects With Neisseria Meningitidis Serogroup C (MenC) Antibody Titers Greater Than or Equal to 1:8 as Measured by Serum Bactericidal Assay Using Human Complement (hSBA)|Results up to 5 years after the fourth dose are presented.|One year, three years, and five years after the fourth dose vaccination.|Analysis was done on the ATP cohort for persistence of each respective timepoint in all evaluable subjects who had assay results available for at least one tested antigen and who had a blood sample taken between 309 and 645 days (Year 1 data), 1039 and 1375 days (Year 3 data) and 1770 and 1882 days (Year 5 data) after administration of fourth dose.||Subjects|||Number
726226|NCT00359983|Primary|Number of Subjects With Anti- Polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to 0.15 Microgram Per Milliliter|Results up to 5 years after the fourth dose are presented.|One year, three years, and five years after the fourth dose vaccination.|Analysis was done on the ATP cohort for persistence of each respective timepoint in all evaluable subjects who had assay results available for at least one tested antigen and who had a blood sample taken between 309 and 645 days (Year 1 data), 1039 and 1375 days (Year 3 data) and 1770 and 1882 days (Year 5 data) after administration of fourth dose.||Subjects|||Number
726227|NCT00360009|Primary|Change in Visual Analogue Mood Scales (VAMS) Tired State|VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.|Pre-surgery baseline to 6 months of DBS stimulation|||T-score||Standard Deviation|Mean
726228|NCT00360009|Primary|Change in Visual Analogue Mood Scales (VAMS) Tense State|VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.|Pre-surgery baseline to 6 months of DBS stimulation|||T-score||Standard Deviation|Mean
726229|NCT00360009|Primary|Change in Visual Analogue Mood Scales (VAMS) Sad State|VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.|Pre-surgery baseline to 6 months of DBS stimulation|||T-score||Standard Deviation|Mean
726230|NCT00360009|Primary|Change in Visual Analogue Mood Scales (VAMS) Happy State|VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.|Pre-surgery baseline to 6 months of DBS stimulation|||T-score||Standard Deviation|Mean
726231|NCT00360009|Primary|Change in Visual Analogue Mood Scales (VAMS) Energetic State|VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.|Pre-surgery baseline to 6 months of DBS stimulation|||T-score||Standard Deviation|Mean
726232|NCT00360009|Primary|Change in Visual Analogue Mood Scales (VAMS) Confused State|VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.|Pre-surgery baseline to 6 months of DBS stimulation|||T-score||Standard Deviation|Mean
726233|NCT00360009|Primary|Change in Visual Analogue Mood Scales (VAMS) Afraid State|VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.|Pre-surgery baseline to 6 months of DBS stimulation|||T-score||Standard Deviation|Mean
727608|NCT00377312|Secondary|1,25 Vitamin D|pg/ml|baseline, daily up to Day 8 and follow-up|||pg/ml||Standard Error|Mean
726234|NCT00360009|Secondary|Change in Letter Fluency Tasks (LFT)|LFT assess frontal lobe function. Performance measure is number of words beginning with a specific letter generated in 1 min. Although no range of possible scores,the more words named in allotted time,the higher the predicted frontal lobe function. Raw score is converted to T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-2.6) signifies a reduction in task performance from pre to post-DBS while a positive T-score difference(0.7) denotes an increase in task performance. The larger the absolute T-score value,the greater the mean change in performance.|Pre-surgery baseline to 6 months of DBS stimulation|||T-score||Standard Deviation|Mean
726235|NCT00360009|Secondary|Change in Beck Depression Inventory (BDI)|BDI is a questionnaire used to measure depression. There is a four-point scale for each of the 21-items of the questionnaire with scores ranging from 0 to 3. Total raw scores range from 0 to 63. The higher the score the greater the severity of depression. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-3.7) indicates a reduction in depression from pre to post-DBS while a positive T-score difference (0.4) denotes an increase in depression. The larger the absolute T-score value,the greater the mean change in depression.|Pre-surgery baseline to 6 months of DBS stimulation|Control Group data not reported for this outcome measure because the purpose of the Control Group was just to test effects of fatigue.||T-score||Standard Deviation|Mean
726236|NCT00360009|Secondary|Change in Spielberger State-Trait Anxiety Inventory (STAI)|STAI measures anxiety. The questionnaire asks the patients how they feel and allows them to respond on a frequency scale that ranges from 1(not at all) to 4(almost always/very much so). Scores range from 20-80 and the higher the score the greater the anxiety level. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-1.4) indicates a reduction in anxiety from pre to post-DBS while a positive T-score difference (0.4) denotes an increase in anxiety. The larger the absolute T-score value,the greater the mean change in anxiety.|Pre-surgery baseline to 6 months of DBS stimulation|Control Group data not reported for this outcome measure because the purpose of the Control Group was just to test effects of fatigue.||T-score||Standard Deviation|Mean
726237|NCT00360009|Primary|Change in Mean T-score of Visual Analogue Mood Scales (VAMS) Angry State|VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.|Pre-surgery baseline to 6 months of DBS stimulation|Control Group data not reported for this outcome measure because the purpose of the Control Group was just to test effects of fatigue.||T-score||Standard Deviation|Mean
726238|NCT00360126|Primary|Number of Participants With Serious Adverse Events (SAEs)|An adverse event (AE) is defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event is therefore any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. An SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Only SAEs were recorded and reported in this extension study.|Up to 54 weeks|All subject population consisted of all participants enrolled into the study and received study drug.||Participants|||Number
726239|NCT00360243|Primary|Change From Baseline to 24 Weeks in Responses to the eDiary Daily Desire Question.|"Change from baseline in the electronic diary (eDiary) Sexual Desire Monthly Total Score standardized to a 28-day period (total score range 0-84). Change from baseline is calculated as the difference between the four week baseline period and Week 21 to Week 24. Patients were asked to record information daily in the eDiary throughout the trial. Every time the eDiary was completed, a desire question was asked. If a patient did not complete the diary on a given day, the patient was not asked to enter desire information for more than a 24-hour retrospective period. The desire item read Indicate your most intense level of sexual desire in the last 24 hours / since your last visit.” Potential responses included no, “low,” “moderate,” or “strong” and was scored 0-3, with 0 indicating no desire and 3 indicating the highest level of desire:
0 = No desire
= Low desire
= Moderate desire
= Strong desire"|baseline to 24 weeks|The Full Analysis Set (FAS) consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, and had at least one on-treatment efficacy assessment. The FAS was analyzed for efficacy.||units on a scale||Standard Error|Least Squares Mean
726240|NCT00360243|Primary|Mean Change From Baseline to 24 Weeks in the Frequency of Satisfying Sexual Events as Measured by the eDiary.|A small personal handheld electronic device (eDiary) was used by the patients to record information about sexual events. Patients were instructed to complete the eDiary every morning. When completing an eDiary entry, patients answered questions regarding their sexual events since their last eDiary entry. If patients missed or were late with their eDiary entry, they entered information about their sexual events covering a maximum time period of the past 7 days; however, they did not enter any information beyond the last entry.|24 weeks|The Full Analysis Set (FAS) consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, and had at least one on-treatment efficacy assessment. The FAS was analyzed for efficacy.||SSEs per week||Standard Deviation|Mean
726241|NCT00360269|Secondary|Clinical Global Impression, Improvement Scale|The Clinical Global Impression - Improvement scale (CGI-I) was used to assess improvement in ADHD symptoms during study participation. CGI-I is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.|12 weeks|||Units on a scale||Standard Deviation|Mean
726242|NCT00360269|Secondary|Wender-Reimherr Adult Attention Deficit Disorder Scale|The WRAADDS is intended to measure the severity of ADHD symptoms in adults. It measures symptoms in seven categories: attention difficulties, hyperactivity/restlessness, temper, affective lability, emotional over-reactivity, disorganization, and impulsivity. The scale rates individual items from 0–2 (0=not present, 1=mild, 2=clearly present), with a minimum score of 0 and maximum score of 46. Reported here is change from Baseline to Week 12 (or LOCF).|Baseline and Week 12|||Units on a scale||Standard Deviation|Mean
726246|NCT00360282|Secondary|Change From Baseline in Subjective Units of Distress to Post Vestibular Stimulus|Subjective report of distress ranging from 0 to 10 based on the method of Wolpe. Zero indicates no distress and 10 indicates severe distress. Measures used in this analysis match the times used in the analysis for Outcome 1.|Pre and Post Stimulus (6 minutes apart)|Ten of the 25 subjects who completed both experimental visits developed negligible motion sickness induced by the stimulus following pre-medication with placebo. These data were not analyzed. It was posited that the presence/absence of vertigo would not impact the analysis of this outcome. The groups were combined for the analysis.||units on a scale||Inter-Quartile Range|Median
726247|NCT00360282|Primary|Change From Baseline in Motion Sickness to Post Vestibular Stimulus|Scores are based on a scale developed by Graybiel which rates seven subjective and objective signs of motion sickness. The total scores ranged from from 0 to 25. Zero indicating no motion sickness. Greater than 16 indicates severe motion sickness. Trials were stopped if scores were 16 or greater. Scores were taken before and after each rotation.|Pre and Post Stimulus (about 6 minutes apart)|Ten of the 25 subjects who completed both experimental visits developed negligible motion sickness induced by the stimulus following pre-medication with placebo. These data were not analyzed. It was posited that the presence/absence of vertigo would not impact the analysis of this outcome. The groups were combined for the analysis.||units on a scale||Inter-Quartile Range|Median
726248|NCT00360308|Secondary|Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) to Week 18 (Including LOCF Data)|Efficacy assessments were recorded by subjects using a home diary card. ON state is when medication is providing benefits to stiffness, slowness, and tremor.|Baseline and Week 18|ITT Population||Hours||95% Confidence Interval|Least Squares Mean
726249|NCT00360308|Secondary|Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) to Week 18 (Including LOCF Data)|Efficacy assessments were recorded by subjects using a home diary card. UPDRS is a standardized assessment of the symptoms and signs of PD. Part III assesses motor activity, based on 14 items, such as gait, facial expression, and rigidity. Participants receive a score of 0-4 points per item, with a higher score indicating more severe symptoms. ON state is when medication is providing benefits to stiffness, slowness, and tremor.|Baseline and Week 18|ITT Population||Scores on a scale||95% Confidence Interval|Least Squares Mean
726250|NCT00360308|Secondary|Mean Change From Baseline in UPDRS Part II (ADL) Score in Total Daily OFF Time to Week 18 (Including LOCF Data)|Efficacy assessments were recorded by subjects using a home diary card. Unified Parkinson’s Disease (PD) Rating Scale (UPDRS) is a standardized assessment of the symptoms and signs of PD. Part II assesses Activities of Daily Living (ADL) based on 13 items, such as speech, hygiene, and falling. Participants receive a score of 0-4 points per item, with a higher score indicating more severe symptoms. OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor.|Baseline and Week 18|ITT Population||Scores on a scale||95% Confidence Interval|Least Squares Mean
726251|NCT00360308|Primary|Mean Change From Baseline in Total Daily OFF Time (Hours) to Week 18 (Including LOCF Data)|Efficacy assessments were recorded by subjects using a home diary card. ON state is when medication is providing benefits to mobility, slowness, and stiffness. OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor.|Baseline and Week 18|The Intent-to-Treat (ITT) Population comprised all randomised patients who took at least one dose of study medication or placebo and who had a valid baseline efficacy measure and at least one post-baseline efficacy measure.||Hours||95% Confidence Interval|Least Squares Mean
726252|NCT00360334|Secondary|Severe Hypoglycemic Rate Per 30 Days|Number of severe hypoglycemic episodes per patient adjusted per 30 days|26 weeks|Full Analysis Set||Number of episodes per 30 days||Full Range|Median
726253|NCT00360334|Secondary|Nocturnal Hypoglycemic Rate Per 30 Days|Number of nocturnal hypoglycemic episodes per patient adjusted per 30 days|26 weeks|Full Analysis Set||Number of episodes per 30 days||Inter-Quartile Range|Median
726254|NCT00360334|Secondary|Hypoglycemic Rate Per 30 Days|Number of hypoglycemic episodes per patient adjusted per 30 days|26 weeks|Full Analysis Set||Number of episodes per 30 days||Inter-Quartile Range|Median
726255|NCT00360334|Secondary|Incidence of Severe Hypoglycemic Episodes|Percent of total patients in each arm experiencing severe hypoglycemia at any point during the 26 week study|26 weeks|Full Analysis Set||percent|||Number
726256|NCT00360334|Secondary|Incidence of Nocturnal Hypoglycemic Episodes|Percent of total patients in each arm experiencing nocturnal hypoglycemia at any point in the 26 week study|26 weeks|Full Analysis Set||percent|||Number
726257|NCT00360334|Secondary|Incidence of Hypoglycemic Episodes|Percent of total patients in each arm experiencing hypoglycemia at any point in the 26 week study|26 weeks|Full Analysis Set||percent|||Number
726258|NCT00360334|Secondary|Change in Apolipoprotein-B|Change in apolipoprotein-B from baseline to endpoint|26 weeks|Full Analysis Set, Last Observation Carried Forward||g/L||Standard Error|Least Squares Mean
726259|NCT00360334|Secondary|Change in Low Density Lipoprotein (LDL) Cholesterol|Change in LDL cholesterol from baseline to endpoint|26 weeks|Full Analysis Set, Last Observation Carried Forward||mmol/L||Standard Error|Least Squares Mean
726260|NCT00360334|Secondary|Change in Fasting Serum Triglycerides|Change in fasting serum triglycerides from baseline to endpoint|26 weeks|Full Analysis Set, Last Observation Carried Forward||mmol/L||Standard Error|Least Squares Mean
726261|NCT00360334|Secondary|Change in TC to HDL Cholesterol Ratio|Change in TC to HDL cholesterol ratio from baseline to endpoint|26 weeks|Full Analysis Set, Last Observation Carried Forward||Ratio||Standard Error|Least Squares Mean
726262|NCT00360334|Secondary|Change in High Density Lipoprotein (HDL) Cholesterol|Change in HDL cholesterol from baseline to endpoint|26 weeks|Full Analysis Set, Last Observation Carried Forward||mmol/L||Standard Error|Least Squares Mean
726263|NCT00360334|Secondary|Change in Fasting Serum Total Cholesterol (TC)|Change in TC from baseline to endpoint|26 weeks|Full Analysis Set, Last Observation Carried Forward||mmol/L||Standard Error|Least Squares Mean
726264|NCT00360334|Secondary|Change in Diastolic Blood Pressure|Change in diastolic blood pressure from baseline to endpoint|26 weeks|Full Analysis Set||mmHg||Standard Error|Least Squares Mean
726265|NCT00360334|Secondary|Change in Systolic Blood Pressure|Change in systolic blood pressure from baseline to endpoint|26 weeks|Full Analysis Set||mmHg||Standard Error|Least Squares Mean
727609|NCT00377312|Primary|Serum Phosphorous|mg/dl|12 hours after the infusion was started then q 8 hours for 7 days, Follow-up 1 week after infusion complete|||mg/dl||Standard Error|Mean
726266|NCT00360334|Secondary|Percent of Patients Achieving 10% Weight Loss|Percent of patients who lost at least 10% of baseline body weight at endpoint|26 weeks|Full Analysis Set, Last Observation Carried Forward. For change in weight, patients should have a baseline and at least one post-baseline weight measurement. Otherwise, these patients are included as non-responders in the analysis.||Percentage of participants|||Number
726267|NCT00360334|Secondary|Percent of Patients Achieving 5% Weight Loss|Percent of patients who lost at least 5% of baseline body weight at endpoint|26 weeks|Full Analysis Set, Last Observation Carried Forward. For change in weight, patients should have a baseline and at least one post-baseline weight measurement. Otherwise, these patients are included as non-responders in the analysis.||Percentage of participants|||Number
726268|NCT00360334|Secondary|Percent Change in Body Weight|Percent change in baseline body weight at endpoint|26 Weeks|Full Analysis Set||Percentage||Standard Error|Least Squares Mean
726269|NCT00360334|Secondary|Change in Body Weight|Change in body weight from baseline to endpoint|26 weeks|Full Analysis Set||kg||Standard Error|Least Squares Mean
726270|NCT00360334|Secondary|Change in Waist-to-hip Ratio|Change in waist-to-hip ratio from baseline to endpoint|26 weeks|Full Analysis Set||Ratio||Standard Error|Least Squares Mean
726271|NCT00360334|Secondary|Change in Waist Circumference|Change in waist circumference from baseline to endpoint|26 Weeks|Full Analysis Set||cm||Standard Error|Least Squares Mean
726272|NCT00360334|Secondary|Change in Body Mass Index (BMI)|Change in BMI from baseline to endpoint|26 weeks|Full Analysis Set||kg/m^2||Standard Error|Least Squares Mean
726273|NCT00360334|Secondary|Change in 7 Point Self Monitored Blood Glucose Profile|Change from baseline to endpoint in self monitored blood glucose levels measured at 7 time points during the day|26 weeks|Full Analysis Set, Last Observation Carried Forward||mmol/L||Standard Deviation|Mean
726274|NCT00360334|Secondary|Percent of Patients Achieving HbA1c < 6.5%|Percent of patients achieving specified HbA1c target at endpoint|26 weeks|Full Analysis Set, Last Observation Carried Forward. Patients with no post-baseline HbA1c measurement are regarded as non-responders in the analysis.||Percentage of participants|||Number
726275|NCT00360334|Secondary|Percent of Patients Achieving HbA1c < 7%|Percent of patients achieving specified HbA1c target at endpoint|26 weeks|Full Analysis Set, Last Observation Carried Forward. Patients with no post-baseline HbA1c measurement are regarded as non-responders in the analysis.||Percentage of participants|||Number
726276|NCT00360334|Secondary|Percent of Patients Achieving HbA1c ≤ 7.4%|Percent of patients achieving specified HbA1c target at endpoint|26 weeks|Full Analysis Set, Last Observation Carried Forward. Patients with no post-baseline HbA1c measurement are regarded as non-responders in the analysis.||Percentage of participants|||Number
726277|NCT00360334|Secondary|Change in Fasting Serum Glucose|Change in fasting serum glucose from baseline (week 0) to endpoint (week 26)|26 weeks|Full Analysis Set, Last Observation Carried Forward||mmol/L||Standard Error|Least Squares Mean
726278|NCT00360334|Secondary|Percent of Patients Who Achieved HbA1c ≤ 7.4% and Weight Gain ≤ 0.5kg|Composite endpoint evaluating effect of treatment on glycemic control and weight|26 weeks|Full Analysis Set; The last post-baseline measurement set of both non-missing HbA1c and weight was used as endpoint value. Patients who did not have a baseline weight measurement and/or missing post-baseline measurements for HbA1c and/or weight were included in the analysis as non-responders.||Percentage of participants|||Number
726279|NCT00360334|Primary|Percent of Patients Who Achieved HbA1c ≤ 7.4% With Minimal Weight Gain (≤ 1kg)|Composite endpoint evaluating effect of treatment on glycemic control and weight|26 weeks|Full Analysis Set; The last post-baseline measurement set of both non-missing HbA1c and weight was used as endpoint value. Patients who did not have a baseline weight measurement and/or missing post-baseline measurements for HbA1c and/or weight were included in the analysis as non-responders.||percentage of participants|||Number
726280|NCT00360360|Secondary|Progression-free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|18 months|||months||95% Confidence Interval|Median
726281|NCT00360360|Primary|Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death||18 months|||months||95% Confidence Interval|Median
726282|NCT00360399|Secondary|Number of Participants Achieving Remission From Major Depressive Episode After 12 Weeks of Combined Treatment, for Those Patients Who do Not Achieve Remission With Monotherapy|The number of participants achieving remission from major depressive episode after 12 weeks of combined treatment consisting of antidepressant plus cognitive behavioral therapy (CBT) treatments. Those originally randomized to receive one of the antidepressants remained on that medication and had CBT sessions added. Participants originally randomized to CBT had escitalopram added at a dose of 10 to 20 mg per day for 12 weeks|Measured after 12 weeks of combined treatment|Participants who did not achieve remission during monotherapy were offered 12 weeks of combination therapy. This sample consists of those participants who consented for the combination therapy part of the trial and who completed the 12 weeks of treatment.||participants|||Number
726283|NCT00360399|Secondary|Number of Participants Experiencing Depression Recurrence Following Remission to Monotherapy Treatment|The number of participants experiencing a recurrence of depression after they had been in remission with the monotherapy treatment they were randomized to receive.|Measured at 6, 9, 12, 15, 18, 21, and 24 months|This population is comprised of participants who completed 12 weeks of treatment, achieved remission, and participated in a follow-up phase that lasted for up to 21 months or until recurrence occurred.||participants|||Number
726284|NCT00360399|Secondary|Number of Participants in Each Category of Response to Treatment of Depressive Symptoms, Among Participants Who Completed the Intervention|"Four mutually exclusive categorical outcomes were defined based on the last valid Hamilton Depression Rating Scale (HDRS) rating at the Week 10 and Week 12 visits:
Non-response: <30% reduction from baseline
Partial Response: 30-49% reduction from baseline
Response without remission: ≥50% reduction from baseline, but HDRS-17 score >7
Remission: HDRS score ≤7"|Measured at Weeks 10 and 12|This population includes participants who completed the trial, per study protocol.||participants|||Number
726441|NCT00363467|Secondary|Severe Regimen-related Toxicity|Number of participants with severe regimen-related toxicity within 2 years posttransplant. Severe regimen-related toxicity was defined as CTC (version 3)grade 4.|up to 100 days post translant|||participants|||Number
726285|NCT00360399|Secondary|Number of Participants in Each Category of Response to Treatment of Depressive Symptoms, in Intent to Treat Sample|"Four mutually exclusive categorical outcomes were defined based on the last valid Hamilton Depression Rating Scale (HDRS) rating at the last observation:
Non-response: <30% reduction from baseline
Partial Response: 30-49% reduction from baseline
Response without remission: ≥50% reduction from baseline, but HDRS-17 score >7
Remission: HDRS score ≤7"|Up to 12 Weeks|The population is defined as all randomized patients who initiated treatment and had at least one follow-up rating assessment.||participants|||Number
726286|NCT00360399|Primary|Remission From Major Depressive Episode Among Participants Who Completed the Intervention|The percentage of participants who achieved remission from a major depressive episode. A score of equal to or greater than 7 on the Hamilton Depression Rating Scale (HDRS) after 10 weeks and 12 weeks of the assigned study treatment was considered to be remission from depression.|Measured at Weeks 10 and 12|This population includes participants who completed the trial, per study protocol.||percentage of participants|||Number
726287|NCT00360399|Primary|Remission From Major Depressive Episode in Intent to Treat Sample|The percentage of participants who achieved remission from a major depressive episode, using a last observation carried forward (LOCF) dataset, defined as all randomized patients who initiated treatment and had at least one follow-up rating assessment. A score of equal to or greater than 7 on the Hamilton Depression Rating Scale (HDRS) at the last observation was considered to be remission from depression.|Up to 12 Weeks|This population consists of all participants who were randomized and returned for at least one study visit. This population was used for the intent to treat analyses and not all of these individuals completed the study.||percentage of participants|||Number
726288|NCT00360412|Secondary|Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) During Open- Label Extension Study|Unified Parkinson’s Disease Rating Scale (UPDRS) is a standardized assessment of the symptoms and signs of Parkinson’s Disease. Part III assesses motor activity, based on 14 items, such as gait, facial expression, and rigidity. Participants receive a score of 0-4 points per item, with a higher score indicating more severe symptoms, for a range of total possible scores of 0-56. ON state is when medication is providing benefits with regard to stiffness, slowness, and tremor.|Baseline, Week 0, Week 8, Week 20, Week 32, Week 44, Week 56, Week 68|Safety Population||Scores on a scale||Standard Deviation|Mean
726289|NCT00360412|Secondary|Mean Change From Baseline in UPDRS Part II (ADL) Score in OFF State (Hours) During Open-label Extension Study|Unified Parkinson’s Disease Rating Scale (UPDRS) is a standardized assessment of the symptoms and signs of Parkinson’s Disease. Part II assesses activities of daily living (ADL) based on 13 items, such as speech, hygiene, and falling. Participants receive a score of 0-4 points per item, with a higher score indicating more severe symptoms, for a range of total possible scores of 0-52. OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor.|Baseline, Week 0, Week, 8, Week 20, Week 32, Week 44, Week 56, Week 68|Safety Population||Scores on a scale||Standard Deviation|Mean
726290|NCT00360412|Secondary|Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) During Open-label Extension Study|ON state is when medication is providing benefits with regard to stiffness, slowness, and tremor. This outcome measure was based on data collected through use of a patient diary.|Baseline, Week 0, Week 4, Week 8, Week 20, Week 32, Week 44, Week 56, Week 68|Safety Population||Hours||Standard Deviation|Mean
726291|NCT00360412|Primary|Mean Change From Baseline in Total Daily OFF Time (Hours) During Open-label Extension Study|OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor. This outcome measure was based on data collected through use of a patient diary.|Baseline, Week 0, Week 4, Week 8, Week 20, Week 32, Week 44, Week 56, Week 68|Safety Population- all subjects entering the open-label extension study who took at least 1 dose of perampanel||Hours||Standard Deviation|Mean
726292|NCT00360490|Secondary|Percentage of Patients With Improvement in the Patients Overall Assessment Scale|“Improved” is classified as ‘very much improved’, ‘much improved’, or ‘improved’ and “not improved” is classified as ‘no change’, ‘worse’, ‘much worse’, or ‘very much worse’.|Up to 6 months|Among of the 165 Full Analysis Set (FAS) subjects, a total of 160 subjects (78 for LNG IUS and 82 for MPA) were available for the analysis.||percentage|||Number
726293|NCT00360490|Secondary|Percentage of Patients With Improvement in the Investigator Global Assessment Scale|“Improved” is classified as ‘very much improved’, ‘much improved’, or ‘improved’ and “not improved” is classified as ‘no change’, ‘worse’, ‘much worse’, or ‘very much worse’|Up to 6 months|Among of the 165 Full Analysis Set (FAS) subjects, a total of 160 subjects (78 for LNG IUS and 82 for MPA) were available for the analysis.||percentage|||Number
726294|NCT00360490|Secondary|Percent Change in Serum Ferritin||Baseline and up to 6 months|Among of the 165 Full Analysis Set (FAS) subjects, a total of 148 subjects (75 for LNG IUS and 73 for MPA) were available for the analysis.||percent change||Full Range|Median
726295|NCT00360490|Secondary|Percent Change in Hematocrit||Baseline and up to 6 months|Among of the 165 Full Analysis Set (FAS) subjects, a total of 150 subjects (75 for LNG IUS and 75 for MPA) were available for the analysis.||percent change||Full Range|Median
726296|NCT00360490|Secondary|Percent Change in Hemoglobin||Baseline and up to 6 months|Among of the 165 Full Analysis Set (FAS) subjects, a total of 150 subjects (75 for LNG IUS and 75 for MPA) were available for the analysis.||percent change||Full Range|Median
726297|NCT00360490|Secondary|Total Number of Bleeding Episodes|A bleeding episode is defined as a light, normal or heavy bleeding, during a minimum of one day. In the LNG IUS group, each cycle has 30 days. In the MPA group, each menstrual cycle starts on the 1st bleeding day (withdrawal bleeding) and lasts until the last non-bleeding day before next withdrawal bleeding starts.|Baseline and up to 6 months|Among of the 165 Full Analysis Set (FAS) subjects, a total of 163 subjects (81 for LNG IUS and 82 for MPA) were available for the analysis.||number of bleeding episodes||Standard Deviation|Mean
726298|NCT00360490|Secondary|Total Number of Spotting Days|In the LNG IUS group, each cycle has 30 days. In the MPA group, each menstrual cycle starts on the 1st bleeding day (withdrawal bleeding) and lasts until the last non-bleeding day before next withdrawal bleeding starts.|Baseline and up to 6 months|Among of the 165 Full Analysis Set (FAS) subjects, a total of 163 subjects (81 for LNG IUS and 82 for MPA) were available for the analysis.||days||Standard Deviation|Mean
726442|NCT00363467|Secondary|Successful Autologous Stem Cell Collection|Number of subjects who were able to collect at least 2 million CD34+ cells/kg|At time of stem cell collection|per protocol||participants|||Number
726299|NCT00360490|Secondary|Total Number of Spotting and Bleeding Days|In the LNG IUS group, each cycle has 30 days. In the MPA group, each menstrual cycle starts on the 1st bleeding day (withdrawal bleeding) and lasts until the last non-bleeding day before next withdrawal bleeding starts.|Baseline and up to 6 months|Among of the 165 Full Analysis Set (FAS) subjects, a total of 163 subjects (81 for LNG IUS and 82 for MPA) were available for the analysis.||days||Standard Deviation|Mean
726300|NCT00360490|Secondary|Total Number of Bleeding Days|In the LNG IUS group, each cycle has 30 days. In the MPA group, each menstrual cycle starts on the 1st bleeding day (withdrawal bleeding) and lasts until the last non-bleeding day before next withdrawal bleeding starts.|Baseline and up to 6 months|Among of the 165 Full Analysis Set (FAS) subjects, a total of 163 subjects (81 for LNG IUS and 82 for MPA) were available for the analysis.||days||Standard Deviation|Mean
726301|NCT00360490|Secondary|Percentage of Subjects Who Completed the Study in Levonorgestrel Intrauterine System (LNG IUS) Group||Baseline and up to 6 months|Among of the 165 Full Analysis Set (FAS) subjects, a total of 160 subjects (79 for LNG IUS and 81 for MPA) were available for the analysis.||percentage of participants|||Number
726302|NCT00360490|Secondary|Percent Change From Baseline MBL to Mid-study MBL (Cycle 3)|The percent change = {(Mid-study MBL - Baseline MBL)/Baseline MBL} x 100.|Baseline and up to 3 months|Among of the 165 Full Analysis Set (FAS) subjects, a total of 160 subjects (79 for LNG IUS and 81 for MPA) were available for the analysis. One subject in LNG IUS, and two subjects in MPA group were not available due to the missing of diary data, and 2 subjects in LNG IUS group were not available due to the invalid baseline data.||Percent change||Standard Deviation|Mean
726303|NCT00360490|Secondary|Absolute Change From Baseline MBL to Mid-study MBL (Cycle 3)|The MBL for each cycle included intermenstrual bleeding in addition to withdrawal bleeding. Mid-study MBL was measured during Cycle 3 of the Treatment Phase.|Baseline and up to 3 months|Among of the 165 Full Analysis Set (FAS) subjects, a total of 160 subjects (79 for LNG IUS and 81 for MPA) were available for the analysis. One subject in LNG IUS, and two subjects in MPA group were not available due to the missing of diary data, and 2 subjects in LNG IUS group were not available due to the invalid baseline data.||milliliter (mL)||Full Range|Median
726304|NCT00360490|Secondary|Percent Change From Baseline MBL to End of Study MBL (Cycle 6)|The percent change = {(End of Study MBL - Baseline MBL)/Baseline MBL} x 100.|Baseline and up to 6 months|Among of the 165 Full Analysis Set (FAS) subjects, a total of 160 subjects (79 for LNG IUS and 81 for MPA) were available for the analysis. One subject in LNG IUS, and two subjects in MPA group were not available due to the missing of diary data, and 2 subjects in LNG IUS group were not available due to the invalid baseline data.||Percent change||Standard Deviation|Mean
726305|NCT00360490|Primary|Percentage of Patients With Successful Treatment|End-of-study MBL < 80 mL and a decrease to a value no greater than 50% of the Baseline MBL was considered to be treatment success.|At 6 months|Among of the 165 Full Analysis Set (FAS) subjects, a total of 160 subjects (79 for LNG IUS and 81 for MPA) were available for the analysis. One subject in LNG IUS, and two subjects in MPA group were not available due to the missing of diary data, and 2 subjects in LNG IUS group were not available due to the invalid baseline data.||Percentage of participants|||Number
726306|NCT00360490|Primary|The Change in Absolute Value From Baseline Menstrual Blood Loss (MBL) to the End-of-study MBL (Cycle 6)|The MBL for each cycle included intermenstrual bleeding in addition to withdrawal bleeding. Baseline MBL was the composite MBL measured during each of the cycles during the Screening Phase. End-of-study MBL was measured during Cycle 6 of the Treatment Phase.|Baseline and up to 6 months|Among of the 165 Full Analysis Set (FAS) subjects, a total of 160 subjects (79 for LNG IUS and 81 for MPA) were available for the analysis. One subject in LNG IUS, and two subjects in MPA group were not available due to the missing of diary data, and 2 subjects in LNG IUS group were not available due to the invalid baseline data.||milliliter (mL)||Full Range|Median
726307|NCT00360529|Secondary|Patient Benefit Evaluation|The Patient Benefit Evaluation is a single question asking the patient whether or not she experienced a meaningful benefit from the study medication during the trial. This question (“Overall, do you believe that you have experienced a meaningful benefit from the study medication?”) was asked upon treatment discontinuation.|Week 24|This question was asked at Week 24 only, so did not include participants who had discontinued the trial prior to that time (e.g., analysis population includes treatment completers only).||participants|||Number
726308|NCT00360529|Secondary|Female Sexual Functioning Index (FSFI) Total Score Change From Baseline at Final Visit|The FSFI© is a self-administered questionnaire to assess FSD, which consists of 19 questions that are scored from ‘0’ to ‘5.’ The scale contains six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. Higher scores indicate higher levels of the domain assessed. The total score is a weighted average of the six domains, each contributing a maximum of 6 points to the total, so the minimum score is 2, while the maximum score of FSFI© is 36.|Baseline, Week 24|The Full Analysis Set (FAS) consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, and had at least one on-treatment efficacy assessment. The FAS was analyzed for efficacy.||score on a scale||Standard Error|Least Squares Mean
726309|NCT00360529|Secondary|Female Sexual Functioning Index (FSFI) Desire Domain Score Change From Baseline at Final Visit|Female Sexual Function Inventory (FSFI) Desire Domain assesses sexual desire or interest with 2 questions ranging from 1 (very low) to 5 (very high). The domain total score is multiplied by 0.6 yielding scores ranging from 1.2 to 6 (higher scores = higher level of desire or interest).|Baseline, Week 24|The Full Analysis Set (FAS) consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, and had at least one on-treatment efficacy assessment. The FAS was analyzed for efficacy.||score on a scale||Standard Error|Least Squares Mean
726317|NCT00360568|Secondary|Change From Baseline in EuroQol Quality of Life Scale (EQ-5D) Visual Analogue Scale (VAS) at Endpoint|The EQ-5D VAS records the participant's self-rated health on a scale from 0–100 where 100 is the 'best imaginable health state' and 0 is the 'worst imaginable health state.'|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Deviation|Mean
726443|NCT00363467|Primary|100-day Non-relapse Mortality|100-day non-relapse mortality is the number of participants who died before day 100 posttransplant from causes other than relapsed disease|100 days post transplant|"Analysis was per protocol"||participants|||Number
726310|NCT00360529|Secondary|Female Sexual Distress Scale - Revised (FSDS-R) Question 13 Score Change From Baseline at Final Visit|Change from baseline in the FSDS-R Question 13 (Bothered by low sexual desire). The FSDS is a measure of female personal distress associated with sexual dysfunction. Reliability and validity of the FSDS (12-item version) has been evaluated in different samples of sexually functional and dysfunctional women. An additional question (Question 13) was added to the validated FSDS© in order to capture distress related to specifically sexual desire so that this domain could be appropriately captured. FSDS plus Question 13 comprises FSDS-R, thus making the FSDS-R a self-administered 13 item questionnaire. The scoring for item 13 is from 0-4, with 4 indicating the highest level of sexual distress.|Baseline, Week 24|The Full Analysis Set (FAS) consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, and had at least one on-treatment efficacy assessment. The FAS was analyzed for efficacy.||score on a scale||Standard Error|Least Squares Mean
726311|NCT00360529|Secondary|Female Sexual Distress Scale - Revised (FSDS-R) Total Score Change From Baseline at Final Visit|"Change from baseline in the Female Sexual Distress Scale - revised (FSDS-R) Total Score with a seven day recall period.
The FSDS is a measure of female personal distress associated with sexual dysfunction. Reliability and validity of the FSDS (12-item version) has been evaluated in different samples of sexually functional and dysfunctional women. An additional question (Question 13) was added to the validated FSDS© in order to capture distress related to specifically sexual desire so that this domain could be appropriately captured. FSDS plus Question 13 comprises FSDS-R, thus making the FSDS-R a self-administered 13 item questionnaire. The maximum total score of the FSDS-R is ‘52’ (score of minimum of 0 and maximum of 4 for each item) and indicates the maximum level of sexual distress (the higher the score, the higher the level of reported sexual desire)."|Baseline, Week 24|The Full Analysis Set (FAS) consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, and had at least one on-treatment efficacy assessment. The FAS was analyzed for efficacy.||score on a scale||Standard Error|Least Squares Mean
726312|NCT00360529|Primary|Sexual Desire Monthly Change on Electronic Diary From Baseline at Final Visit|"Change from baseline in eDiary Sexual Desire Monthly Total Score standardized to a 28-day period. Change from baseline calculated as the difference between the 4 week baseline period and Week 21 to Week 24. Patients recorded information daily throughout trial. Every time the eDiary was completed, a desire question was asked. If a patient did not complete the diary on a given day, the patient was not asked to enter desire information for more than a 24-hour retrospective period. The desire item read Indicate your most intense level of sexual desire in the last 24 hours/since your last visit.” Potential responses included no, “low,” “moderate,” or “strong, scored 0-3 (0 indicating no desire and 3 indicating the highest level of desire):
0 = No desire
= Low desire
= Moderate desire
= Strong desire
Total score ranged from 0-84, with higher scores reflecting stronger desire). Monthly desire score was calculated as 28 x (sum of daily desire scores/number of responses)."|Baseline, Week 24|The Full Analysis Set (FAS) consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, and had at least one on-treatment efficacy assessment. The FAS was analyzed for efficacy.||units on a scale||Standard Error|Least Squares Mean
726313|NCT00360529|Primary|Satisfying Sexual Event Monthly Change From Baseline at Final Visit|Change from baseline in the frequency of sexual satisfying events, as measured via e-Diary, standardized to a 28-day period. Change from baseline is calculated as the difference between the four week baseline period and Week 21 to Week 24.|Baseline, Week 24|The Full Analysis Set (FAS) consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, and had at least one on-treatment efficacy assessment. The FAS was analyzed for efficacy.||number of events||Standard Deviation|Mean
726314|NCT00360555|Primary|Change From Baseline in the Monthly Sum of Responses Recorded in the eDiary to the Daily Desire Question.|"Change from baseline in the electronic diary (eDiary) Sexual Desire Monthly Total Score standardized to a 28-day period (score range 0-84). Change from baseline is calculated as the difference between the four week baseline period and Week 21 to Week 24. Patients were asked to record information daily in the eDiary throughout the trial. Every time the eDiary was completed, a desire question was asked. If a patient did not complete the diary on a given day, the patient was not asked to enter desire information for more than a 24-hour retrospective period. The desire item read Indicate your most intense level of sexual desire in the last 24 hours / since your last visit.” Potential responses included no, “low,” “moderate,” or “strong” and was scored 0-3, with 0 indicating no desire and 3 indicating the highest level of desire:
0 = No desire
= Low desire
= Moderate desire
= Strong desire"|baseline to 24 weeks|Participants who received at least one post-dose on-treatment efficacy assessment were included in the Full Analysis Set (FAS). Efficacy endpoints were analyzed primarily using the FAS.||units on a scale||Standard Error|Least Squares Mean
726315|NCT00360555|Primary|Change From Baseline in the Frequency of Satisfying Sexual Events (SSE) as Recorded in the eDiary.|"For endpoints collected on the eDiary, responses are accumulated on a monthly basis using the following algorithms.
For satisfying sexual events:
Total monthly events = 28 x (sum of the number of events) / (sum of number of days entered)"|baseline to 28 weeks|Participants who received at least one post-dose on-treatment efficacy assessment were included in the Full Analysis Set (FAS). Efficacy endpoints were analyzed primarily using the FAS.||SSEs per 28 days||Standard Deviation|Mean
726316|NCT00360568|Secondary|Change From Baseline in Zarit Burden Interview (ZBI) Total Score at Endpoint|The ZBI is a 22-item questionnaire regarding the caregiver/subject relationship and evaluates the caregiver's health condition, psychological well-being, finances and social life. Each question is answered on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=quite frequently, and 4=nearly always). The caregiver burden is evaluated by the total score (range 0 to 88) obtained from the sum of the answers to the 22 questions. Higher scores are associated with a higher level of burden for the caregiver.|Baseline, Endpoint (Month 12 months or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Deviation|Mean
726353|NCT00360685|Primary|Incidence of Severe Mucositis|Mucositis was assessed prospectively daily while the patient was hospitalized and graded retrospectively based on nurse and clinician assessments according to the clinical criteria set forth in the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 3.0). Severe mucositis as defined as grade 3 or grade 4.|2 year|Intent to treat||participants|||Number
726318|NCT00360568|Secondary|Change From Baseline in EuroQol Quality of Life Scale (EQ-5D) Summary Index at Endpoint|The EQ-5D is a participant answered questionnaire scoring 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that essentially attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 to 1.00 with positive change indicating improvement.|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Deviation|Mean
726319|NCT00360568|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Bodily Discomfort Domain Score at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson’s disease patients. The PDQ-39 Domain: Bodily Discomfort includes 3 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Deviation|Mean
726320|NCT00360568|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Communication Domain Score at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson’s disease patients. The PDQ-39 Domain: Communication includes 3 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Deviation|Mean
726321|NCT00360568|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Cognition Domain Score at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson’s disease patients. The PDQ-39 Domain: Cognition includes 4 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Deviation|Mean
726322|NCT00360568|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Social Support Domain Score at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson’s disease patients. The PDQ-39 Domain: Social Support includes 3 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Deviation|Mean
726323|NCT00360568|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Stigma Domain Score at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson’s disease patients. The PDQ-39 Domain: Stigma (e.g., social embarrassment) consists of 4 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Deviation|Mean
726324|NCT00360568|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Emotional Well-Being Domain Score at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson’s disease patients. The PDQ-39 Domain: Emotional Well-being (e.g., feelings of isolation) includes 6 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Deviation|Mean
726354|NCT00360698|Secondary|Rate of Severe Symptomatic Hypoglycemia||during treatment period (12 weeks)|Safety population||Number of hypoglycemia per patient-year||Standard Deviation|Mean
726355|NCT00360698|Secondary|Rate of Nocturnal Symptomatic Hypoglycemia With Plasma Glucose < 70mg/dL||during treatment period (12 weeks)|Safety population||Number of hypoglycemia per patient-year||Standard Deviation|Mean
726325|NCT00360568|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Activities of Daily Living Domain Score at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson’s disease patients. The PDQ-39 Domain: Activities of Daily Living (e.g., difficulty cutting food) includes 6 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Deviation|Mean
726326|NCT00360568|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Mobility Domain Score at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson’s disease patients. The PDQ-39 Domain: Mobility (e.g., fear of falling when walking) includes 10 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Deviation|Mean
726327|NCT00360568|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson’s disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The PDQ-39 Summary Index is the sum of all answers divided by the highest score possible (i.e. number of answers multiplied by 4) which is multiplied by 100 to put the score on a 0-100 scale. Higher scores are associated with more severe symptoms.|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Deviation|Mean
726328|NCT00360568|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score at Endpoint|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part IV Score is the sum of the answers to the 11 questions that comprise Part IV, each of which are measured on a 5-point scale (0-4) or a 2-point scale (0 or 1). The Part IV score ranges from 0-23 and higher scores are associated with more disability.|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Deviation|Mean
726329|NCT00360568|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Endpoint|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The total score is the sum of the responses to the 31 questions (44 answers) that comprise Parts I-III of the scale. The total score will range from 0-176, with 176 representing the worst (total) disability, and 0 representing no disability.|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Deviation|Mean
726330|NCT00360568|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at Endpoint|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part III score is the sum of the 27 answers provided to the 14 Part III questions, each of which are measured on a 5-point scale (0-4). The Part III score ranges from 0-108 and higher scores are associated with more disability.|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Deviation|Mean
726331|NCT00360568|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at Endpoint|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part II score is the sum of the answers to the 13 questions that comprise Part II, each of which are measured on a 5-point scale (0-4). The Part II score ranges from 0-52 and higher scores are associated with more disability.|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Deviation|Mean
726332|NCT00360568|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score at Endpoint|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part I Score is the sum of the answers to the 4 questions that comprise Part I, each of which are measured on a 5-point scale (0-4). The Part I score ranges from 0-16 and higher scores are associated with more disability.|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Deviation|Mean
726356|NCT00360698|Secondary|Rate of Symptomatic Hypoglycemia With Plasma Glucose < 70mg/dL||during treatment period (12 weeks)|Safety population||Number of hypoglycemia per patient-year||Standard Deviation|Mean
726357|NCT00360698|Secondary|Daily Dose of Insulin Glulisine|Mean of 3 daily doses reported during the week prior to the final visit|at the end of treatment (week 24)|Modified ITT population, LOCF||units of insulin glulisine per day||Standard Deviation|Mean
726358|NCT00360698|Secondary|Daily Dose of Insulin Glargine|Mean of 3 daily doses reported during the week prior to the final visit|at the end of treatment (week 24)|Modified ITT population, LOCF||units of insulin glargine per day||Standard Deviation|Mean
726333|NCT00360568|Secondary|Clinical Global Impression - Status (CGI-S) Score at Baseline and Clinical Global Impression - Improvement (CGI-I) Score at Endpoint|The CGI-S is a global assessment by the Investigator of current symptomatology and impact of illness on functioning. The ratings of the CGI-S are as follows: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, and 7 = among the most extremely ill. The CGI-I is a global assessment by the Investigator of the change in clinical status since the start of treatment. The CGI-I ratings are as follows: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse.|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment; n=number of participants with assessment at timepoint.||units on a scale||Standard Deviation|Mean
726334|NCT00360568|Secondary|"Change From Baseline in Average Daily On Time Without Troublesome Dyskinesia at Month 12"|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. “On time without troublesome dyskinesia (involuntary muscle movement) is defined as on time without dyskinesia and on time with non-troublesome dyskinesia. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Positive change from Baseline for on time without troublesome dyskinesia indicates improvement."|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.||hours||Standard Deviation|Mean
726335|NCT00360568|Secondary|"Change From Baseline in Average Daily Normalized On Time With Troublesome Dyskinesia at Endpoint"|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis."|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.||hours||Standard Deviation|Mean
726336|NCT00360568|Secondary|"Change From Baseline in Average Daily Off Time at Endpoint"|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Negative change from baseline for off time indicates improvement."|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.||hours||Standard Deviation|Mean
726337|NCT00360568|Primary|Number of Participants Taking at Least 1 Concomitant Medication During the Study|Concomitant medications include medications started on or after the first open-label LCIG infusion as well as medications started prior to the first open-label infusion but continued during the study.|12 months|Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion.||participants|||Number
726338|NCT00360568|Primary|Columbia-Suicide Severity Rating Scale (C-SSRS) Findings|The Columbia-Suicide Severity Rating Scale (C-SSRS) is a systematically administered instrument developed to track suicidal adverse events across a treatment study. The instrument is designed to assess suicidal behavior and ideation, track and assess all suicidal events, as well as the lethality of attempts. Suicidal ideation categories include the following: wish to be dead; nonspecific active suicidal thoughts; active suicidal ideation without intent to act; active suicidal ideation with some intent to act but no plan; active suicidal ideation with plan and intent. Suicidal behavior categories include the following: actual attempt; interrupted attempt; aborted attempt; preparatory acts or behavior; suicidal behavior; completed suicide.|up to 12 months|Safety Data Set: all enrolled participants who received at least one study S187-3-3003 LCIG infusion with a C-SSRS assessment during the study.||participants|||Number
726339|NCT00360568|Primary|Number of Participants With Clinically Significant Neurological Examination Findings|"The neurologic examination was to be done during On time. The neurological examination assessed: cranial nerves – assessment of cranial nerves II – XII, excluding fundoscopic examination; motor system – assessment of tone, strength, and abnormal movements; sensory system – including light touch, pinprick, joint position, and vibratory sense; reflexes – assessment of deep tendon reflexes and plantar responses (Babinski sign); coordination – assessment of upper and lower extremities; gait – assessment of base and tandem gait; station – assessment of posture and stability."|up to 12 months|Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had a neurological examination.||participants|||Number
726340|NCT00360568|Primary|Number of Participants With Confirmed Cases of Melanoma|A comprehensive assessment for the presence of melanoma was performed during the screening period and at early termination/end of study by a dermatologist experienced with the diagnosis of the condition. If a suspicious lesion was present, a biopsy was obtained for proper diagnosis.|up to Month 12|Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion.||participants|||Number
726359|NCT00360698|Secondary|Change in Weight||from baseline to the end of treatment (week 24)|Modified ITT population, LOCF||kg||Standard Error|Least Squares Mean
726360|NCT00360698|Secondary|Change in Daily Mean Plasma Glucose||from baseline to the end of treatment (week 24)|Modified ITT population, LOCF||mg/dL||Standard Error|Least Squares Mean
726361|NCT00360698|Secondary|Daily Mean Plasma Glucose||at the end of treatment (week 24)|Modified ITT population, LOCF||mg/dL||Standard Deviation|Mean
726362|NCT00360698|Secondary|Change in Glycosylated Haemoglobin (HbA1c) Value||from baseline to the end of treatment (week 24)|Modified ITT population, LOCF||percent||Standard Error|Least Squares Mean
726341|NCT00360568|Primary|Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score at Endpoint|"The AIMS is an investigator-completed rating scale that has a total of 12 items rating involuntary movements of various areas of the participant's body. Items 1 through 10 are rated on a 5-point scale of severity from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), to 4 (severe), and items 11 and 12 are yes/no questions concerning problems with teeth or dentures. The total AIMS score was calculated by summing items 1-10, with a possible range of 0-40; a negative change indicates improvement. The AIMS was to be performed at consistent times, when the subject was experiencing his/her worst On time (dyskinesia [involuntary muscle movement])."|Baseline, Endpoint (Month 12 or last post-baseline visit)|Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion; n=number of participants with assessment at timepoint.||units on a scale||Standard Deviation|Mean
726342|NCT00360568|Primary|Summary of Minnesota Impulsive Disorder Interview (MIDI) Assessment of Intense Impulsive Behavior at Baseline (BL) and Post-baseline (PBL)|The MIDI is a validated assessment of impulsive behavior consisting of a semistructured clinical interview assessing pathological gambling, trichotillomania (compulsive hair-pulling), kleptomania (compulsive stealing), pyromania (compulsive fire-setting), intermittent explosive disorder, compulsive buying, and compulsive sexual behavior.|Baseline, Post-baseline (up to Month 12)|Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion; n=number of participants with assessment at timepoint.||participants|||Number
726343|NCT00360568|Primary|Number of Participants With Sleep Attacks at Baseline and Endpoint|To prospectively monitor for the possible development of sleep attacks, participants were asked if they had experienced any events in which they fell asleep suddenly or unexpectedly, including while engaged in some activity (e.g., eating/drinking, speaking, or driving) or at rest, with or without any previous warning of sleepiness.|Baseline, Endpoint (Month 12 or last post-baseline visit)|Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion.||participants|||Number
726344|NCT00360568|Primary|Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Parameters|Terms abbreviated in the table include heart rate (HR) in beats per minute (bpm), PR interval (PRI), QT interval corrected for heart rate using Bazett's formula (QTcB), and QT interval corrected for heart rate using Fridericia's formula (QTcF). Increase and decrease are signified by ↑ and ↓, respectively.|12 months|Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion.||participants|||Number
726345|NCT00360568|Primary|Number of Participants With Potentially Clinically Significant Vital Sign Parameters|Terms abbreviated in the table include supine systolic blood pressure (SuSBP), standing systolic blood pressure (StSBP), orthostatic systolic blood pressure (OSBP), supine diastolic blood pressure (SuDBP), standing diastolic blood pressure (StDBP), orthostatic diastolic blood pressure (ODBP), supine pulse (SuP) in beats per minute (bpm), standing pulse (StP), and body temperature (Temp). Increase and decrease are signified by ↑ and ↓, respectively.|12 months|Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion; n=number of participants with assessment.||participants|||Number
726346|NCT00360568|Primary|Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters|Terms abbreviated in the table include upper limit of normal (ULN), male (m), and female (f).|12 months|Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion; n=number of participants with an assessment.||participants|||Number
726347|NCT00360568|Primary|Number of Participants With Potentially Clinically Significant Values for Hematology Parameters|Terms abbreviated in the table include females (f) and males (m).|12 months|Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had an assessment.||participants|||Number
726348|NCT00360568|Primary|Number of Participants With Device Complications|Complications of the infusion device were collected. Pump, intestinal tube, PEG, stoma, and other complications included (but were not limited to) device breakage, device leakage, device malfunction, device misuse, device occlusion, intentional and unintentional device removal by participant, complication of device insertion, device dislocation, device breakage, device dislocation, and device site reaction.|12 months|Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion.||participants|||Number
726349|NCT00360568|Primary|Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths and Discontinuations Due to AEs|AE=any untoward medical occurrence which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that: results in death; is life-threatening (an event in which the subject was at risk of death at the time of the event); requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or other important medical events. Treatment-emergent events (TEAE or TESAE)=those starting after the first dose of study drug. Severe=severity reported as 'severe' or missing. Possibly or Probably Treatment Related=drug-event relationship reported as 'possible', 'probable' or missing. Death=a fatal outcome of an SAE or AE.|From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J, plus 30 days.|Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion.||participants|||Number
726350|NCT00360672|Primary|Number of Participants With a Response (Complete Remissions (CR), Complete Remissions With Incomplete Platelet Recovery [CRp] and Partial Responses)|Response for Acute Myeloid Leukemia (AML) according to 2003 International Working Group (IWG) criteria: CR required absolute neutrophil count (ANC) >1 * 10^9/L, platelet count ≥100 * 10^9/L, < 5% of blast cells in bone marrow. CRp: as above except platelet count <100 * 10^9/L. Partial remission: as CR except for presence of 5-25% marrow blasts and with a decrease of marrow blast at least 50%. Response for Myelodysplastic Syndrome (MDS) was defined based on the 2006 IWG criteria. All participants with MDS who achieved hematological CR, Partial Response (PR), marrow CR, and hematological improvement considered responders.|Following three 28-day cycles evaluated for response|||participants|||Number
726351|NCT00360685|Secondary|Overall Survival|number of participants alive at one year|1 year|intent to treat||participants|||Number
726352|NCT00360685|Secondary|Incidence of Acute Graft-vs-host Disease (aGVHD)|incidence of aGVHD (grades 2 - 4) 100 days post allogeneic hematopoietic cell transplantation|100 days post transplant|intent to treat||participants|||Number
726363|NCT00360698|Secondary|Glycosylated Haemoglobin (HbA1c) Value||at the end of treatment (week 24)|Modified ITT population, LOCF||percent||Standard Deviation|Mean
726364|NCT00360698|Primary|Patients With Glycosylated Haemoglobin (HbA1c) Value < 7%|Glycosylated Haemoglobin (HbA1c) is a biological parameter that reflects the blood glucose concentration over a long period of time. It is the standard parameter for glycemic control follow -up in diabetic patients. this parameter is expressed in percentage (%) and the target in diabetes management is to reach a HbA1c <7%|at the end of treatment (week 24)|Modified Intent to treat (ITT) population, LOCF (Last Observation Carried Forward)||percentage of participants|||Number
726365|NCT00360724|Other Pre-specified|Resting-state Functional Connectivity Magnetic Resonance Imaging(fMRI)|To use resting-state fMRI to study the effects of antidepressant therapy on default mode network (DMN) connectivity density.|Follow up|||percentage of connecting nods||Standard Deviation|Mean
726366|NCT00360724|Other Pre-specified|Resting-state Functional Connectivity Magnetic Resonance Imaging(fMRI)|To use resting-state fMRI to study the effects of antidepressant therapy on default mode network (DMN) connectivity density.|Baseline|||percentage of connecting nods||Standard Deviation|Mean
726367|NCT00360724|Secondary|Global Assessment of Functioning Scale (GAF)|"A commonly used rating scale for global social function.
Range from 0 to 100; higher score=better functioning. 91 - 100 No symptoms. 81 - 90 Absent or minimal symptoms 71 - 80 no more than slight impairment in social, occupational, or school functioning (e.g., temporarily falling behind in schoolwork).
61 - 70 Some mild symptoms 51 - 60 Moderate symptoms 41 - 50 Serious symptoms 31 - 40 Some impairment in reality testing or communication 21 - 30 Behavior is considerably influenced by delusions or hallucinations or serious impairment, in communication or judgment 11 - 20 Some danger of hurting self or others
1 - 10 Persistent danger of severely hurting self or others or persistent inability to maintain minimal personal hygiene or serious suicidal act with clear expectation of death.
0 Inadequate information"|Baseline|subjects for whom post-baseline data were available||points on rating scale||Standard Deviation|Mean
726368|NCT00360724|Secondary|Beck Depression Inventory (BDI)|"Beck Depression Inventory (BDI)is a 21-question multiple-choice self-report inventory, one of the most widely used instruments for measuring the severity of depression.
When the test is scored, a value of 0 to 3 is assigned for each answer and then the total score is compared to a key to determine the depression's severity. The standard cut-offs are as follows:[7]
0–9: indicates minimal depression 10–18: indicates mild depression 19–29: indicates moderate depression 30–63: indicates severe depression.
Higher total scores indicate more severe depressive symptoms."|Baseline|subjects for whom post-baseline data was available||Scores on a scale||Standard Deviation|Mean
726369|NCT00360724|Secondary|Cornell Dysthymia Rating Scale (CDRS)|"CDRS is a 20-item clinician-rated inventory for chronic depressive symptoms. Each item was characterized by an explanatory or illustrative description and rated from 0 (symptom absent) to 4 (severe symptoms).
Scores from 0 to 82 with higher score indicating worse depression"|Baseline|subjects for whom data post baseline were available||Scores on a scale||Standard Deviation|Mean
726370|NCT00360724|Secondary|Clinical Global Impressions Improvement(CGI-I)|"The Clinical Global Impression - Improvement(CGI-I) is a 7-point scale that rate patient's total improvement whether or not comparing to his/her condition at baseline.
0 = Not assessed
= Very much improved
= Much improved
= Minimally improved
= No change
= Minimally worse
= Much worse
= Very much worse Higher score=greatest worsening"|10 weeks|subjects for whom post-baseline data was available||Scores on a scale||Standard Deviation|Mean
726371|NCT00360724|Secondary|Beck Depression Inventory (BDI)|"Beck Depression Inventory (BDI)is a 21-question multiple-choice self-report inventory, one of the most widely used instruments for measuring the severity of depression.
When the test is scored, a value of 0 to 3 is assigned for each answer and then the total score is compared to a key to determine the depression's severity. The standard cut-offs are as follows:[7]
0–9: indicates minimal depression 10–18: indicates mild depression 19–29: indicates moderate depression 30–63: indicates severe depression.
Higher total scores indicate more severe depressive symptoms."|Week 10|subjects fro whom post-baseline data was available||Scores on a scale||Standard Deviation|Mean
726372|NCT00360724|Secondary|Global Assessment of Functioning Scale (GAF)|"A commonly used rating scale for global social function.
Range from 0 to 100; higher score=better functioning. 91 - 100 No symptoms. 81 - 90 Absent or minimal symptoms 71 - 80 no more than slight impairment in social, occupational, or school functioning (e.g., temporarily falling behind in schoolwork).
61 - 70 Some mild symptoms 51 - 60 Moderate symptoms 41 - 50 Serious symptoms 31 - 40 Some impairment in reality testing or communication 21 - 30 Behavior is considerably influenced by delusions or hallucinations or serious impairment, in communication or judgment 11 - 20 Some danger of hurting self or others
1 - 10 Persistent danger of severely hurting self or others or persistent inability to maintain minimal personal hygiene or serious suicidal act with clear expectation of death.
0 Inadequate information"|Week 10|subjects for whom post-baseline data were available||points on rating scale||Standard Deviation|Mean
726373|NCT00360724|Secondary|Cornell Dysthymia Rating Scale (CDRS)|"CDRS is a 20-item clinician-rated inventory for chronic depressive symptoms. Each item was characterized by an explanatory or illustrative description and rated from 0 (symptom absent) to 4 (severe symptoms).
Scores from 0 to 82 with higher score indicating worse depression"|Week 10|subjects for whom data post baseline were available||scores on a scale||Standard Deviation|Mean
726374|NCT00360724|Primary|Hamilton Depression Rating Scale (HDRS) - 24 Total Score|HDRS-24 total score, standardly used rating scale for depression. Score 0-7 no depression; Score 8-16 mild depression; Score 17-23 moderate depression; Score 24 and up severe depression. Range= 0 to 75, higher score=worse depression|Baseline|Patients for whom post-baseline data was available and scored 2 or less on the suicide item either at baseline or during the course of treatment.||Scores on a scale||Standard Deviation|Mean
726375|NCT00360724|Primary|Hamilton Depression Rating Scale (HDRS) - 24 Total Score|HDRS-24 total score, standardly used rating scale for depression. Score 0-7 no depression; Score 8-16 mild depression; Score 17-23 moderate depression; Score 24 and up severe depression. Range= 0 to 75, higher score=worse depression|Week 10|Patients for whom post-baseline data was available and scored 2 or less on the suicide item either at baseline or during the course of treatment.||Scores on a scale||Standard Deviation|Mean
726376|NCT00360828|Secondary|Overall Survival at 12 Months|Patients surviving 12 months after last dose of drug|12 months post treatment end|All participants who received at least one dose of drug||participants|||Number
726377|NCT00360828|Secondary|Frequency and Severity of Toxicity|Toxicities assessed through 3 months|3 months|The low accrual rate prevented us from completing the planned analysis.|||||
726380|NCT00360828|Primary|Number of Participants With Objective Response After 3 Cycles of Treatment|The intent was to have 63 evaluable participants to determine the Objective Response Rate utilizing Criteria for Response, Progression and Relapse according to the McDonald Criteria. A measurement is made of the maximal enhancing tumor diameter on a single axial gadolinium-enhanced T1-weighted section, and then the largest perpendicular diameter is measured on the same image. The product of the 2 diameters is calculated, and the measurements are repeated with each scan. Measurements from multiple lesions are summed.|3 cycles (21 day cycles)|All participants having stable disease||participants|||Number
726381|NCT00360971|Secondary|Time to Second Primary Tumor|Second primary tumors other than basal cell will be considered.|From registration to 10 years.||||||
726382|NCT00360971|Secondary|Progression-free Survival||From registration to 10 years.||||||
726383|NCT00360971|Secondary|Overall Survival||From registration to 10 years.||||||
726384|NCT00360971|Secondary|Time to Onset of Mucositis as Measured by the World Heath Organization (WHO) Scale||From the start of treatment to 15 weeks||||||
726385|NCT00360971|Secondary|Incidence of Mucositis as Measured by the World Heath Organization (WHO) Scale||From the start of treatment to 15 weeks||||||
726386|NCT00360971|Primary|Duration of Oral Mucositis as Measured in Terms of Days|"Duration in days of World Heath Organization (WHO) Grades 3 and 4 oral mucositis during the acute period (defined to be 105 days [15 weeks] or less from the start of treatment); duration is calculated from the onset of a Grade 3 or 4 oral mucositis to the day when an oral mucositis of ≤ Grade 2 is reported after the last oral mucositis of Grade 3 or 4. Patients with grade 0-2 mucositis have a duration of 0.
This study required 298 patients to detect via two-sided t-test a reduction of mean duration of at least 9 days from 29 days (standard deviation = 23 days) on the placebo arm with 90% power and alpha = 0.05.
Statistical testing was not done due to the small sample size."|From the start of treatment to 15 weeks|All eligible patients.||Days||Standard Deviation|Mean
726387|NCT00361140|Primary|Non-relapse Mortality|The number of participants dead due to causes unrelated to relapse within the first 100 days post transplant.|100 days|Intent to treat||participants|||Number
726388|NCT00361140|Secondary|Severe Venous Occlusive Disease (VOD)/ Sinusoidal Obstructive Syndrome (SOS)|The number of subjects with severe VOD / SOS; severity staged according to criteria set forth by McDonald G.B., Hinds M.S., Fisher L.D., et al. Veno-occlusive disease of the liver and multiorgan failure after bone marrow transplantation: a cohort study of 355 patients. Ann Intern Med. 1993;118:255-267. Assessed within the first 100 days post transplant.|100 days|Intent to treat||participants|||Number
726389|NCT00361218|Primary|Serum Brain-derived Neurotrophic Factor (BDNF) Levels||8 weeks|||pg/mL||Standard Deviation|Mean
726390|NCT00361218|Primary|Quantitative Electroencephalogram Measurements||8 weeks||||||
726391|NCT00361231|Secondary|Overall Response Rate|To assess the overall response rate of GEMOX-B in patients with advanced BTC. Response rate is determined through Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|2 years|||percentage of participants|||Number
726392|NCT00361231|Primary|Median Progression Free Survival|To assess the median progression free survival in patients with BTC on GEMOX-B. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. In addition, death in the absence of radiological disease progression was also categorized as progression.|2 years|||months||95% Confidence Interval|Median
726393|NCT00361257|Secondary|Changes in Alternate Frontal Systems Z-Score|The alternate frontal systems was defined as a mean of age and education adjusted z score of Interference task, and age, sex, education, and African-American ethnicity adjusted z score of Trail Making Part B. The outcome was the 24 week change in alternate frontal systems z-score (week 24-baseline).|At baseline and week 24|The analysis was based on observed data.||z-score||Standard Deviation|Mean
726394|NCT00361257|Secondary|Changes in Alternate Verbal Memory Z-Score|The alternate verbal memory was defined as a mean of age and education adjusted z score of trials 1 to 3 and delayed recall tests. The outcome is the 24 week change in alternate verbal memory z-score (week 24-baseline).|At baseline and week 24|The analysis is based on observed data.||z-score||Standard Deviation|Mean
726395|NCT00361257|Secondary|Changes in Alternate Psychomotor Function Z-Score|The alternate psychomotor function is defined as the mean of age, sex, education, and African-American ethnicity adjusted z scores of Trail Making Part A (TMA), and age and education adjusted z score of Symbol Digit (SYD). The outcome is the 24 week change in alternate psychomotor function z-score (week 24-baseline).|At baseline and week 24|The analysis was based on the observed data.||z-score||Standard Deviation|Mean
726396|NCT00361257|Secondary|Changes in Neurotransmitter Levels (Unit = uM Only)|Neurotransmitter levels (Glutamate, Tryptophan, Anthranilic Acid, Quinolinic Acid, Kynurenin, and 3-Hydroxykynurenine). The outcome is the 24 week change (week 24-baseline).|At pre-entry and Week 24|Participants who were willing to receive the lumber punctures at week 0 and 24.||uM||Inter-Quartile Range|Median
726397|NCT00361257|Secondary|Changes in Markers of Oxidative Stress (Unit = Pixels/mm2 Only)|Protein marker of oxidative stress (Neurofilament heavy polypeptide). The outcome is the 24 week change (week 24-baseline).|At pre-entry and Week 24|Participants who were willing to receive the lumber punctures at week 0 and 24.||Pixels/mm^2||Inter-Quartile Range|Median
726398|NCT00361257|Secondary|Changes in Markers of Oxidative Stress and Immune Activation (Unit=pg/mL Only)|Protein markers of oxidative stress (Protein carbonyls) and markers of immune activation (TNF-a, IL-6,CXCL8, Hepatocyte growth factor, Osteopontin, sFAS, sFAS ligand, and CXCL12). For all markers, the outcome is the 24 week change (week 24-baseline).|At pre-entry and Week 24|Participants who were willing to receive the lumber punctures at week 0 and 24.||pg/mL||Inter-Quartile Range|Median
726399|NCT00361257|Secondary|Changes in Protein Markers of Oxidative Stress (Unit = Counts Per Second Only)|Protein marker of oxidative stress (Ceramides, Monohexosylceramides, Dihydro Glycosyl Galceramides, and Dihexosylceramides). For all markers, the outcome is the 24 week change (week 24-baseline).|At pre-entry and Week 24|Participants who were willing to receive the lumber punctures at week 0 and 24.||counts per second||Inter-Quartile Range|Median
727610|NCT00377312|Primary|Ionized Serum Calcium|mg/dl|12 hours after the infusion was started then q 8 hours for 7 days, Follow-up 1 week after infusion complete|||mg/dl||Standard Error|Mean
726400|NCT00361257|Secondary|Changes in Medication Management Test (Modified)|The medication management test (modified) is designed to assess participants' medication management ability and their own medications and management. It’s the number of how many times participants correctly answered 16 questions. The score ranges between 0 and 16, and higher score indicates better medication management.|At baseline and weeks 24|The analysis was based on observed data.||scores on a scale||Standard Deviation|Mean
726401|NCT00361257|Secondary|Changes in Instrumental Activities of Daily Living Questionnaire|The Instrumental Activities of Daily Living (IADL) questionnaire is designed to learn more about how subjects are able to perform common tasks. There are 16 common tasks. For each task, if the score at the time of evaluation is worse than the best in the past, an indicator of 1 is given. Otherwise, the indicator is 0. The overall IADL score is a sum of 16 indicators divided by 16; therefore, the range is between 0 and 1 and the lower score is better. The 24-week change of IADL score was changed into a categorical variable (no change/worse vs. better) at week 24 compare to baseline.|At baseline and week 24|The analysis was based on observed data.||participants|||Number
726402|NCT00361257|Secondary|Change of HIV Plasma RiboNucleic Acid (RNA) Viral Load|The original scale of HIV RNA viral load is between 30 copies/mL to infinitive. The minimum score of 30 is the lowest detectable value. The summary table categorized this continuous value to a dichotomous variable (<30 copies/mL and >= 30 copies/mL).|At baseline and week 24|The summary statistics were based on observed data. No statistical analysis was conducted.||participants|||Number
726403|NCT00361257|Secondary|Number of Participants With Grade 2 or Higher Toxicity and/or Signs and Symptoms|Grade or higher means that adverse events were moderate, severe, or life-threatening, or death. Grade 2 or higher adverse events are lised in the Adverse Event section.|Throughout study up to week 48|The analysis includes all randomized participants. A total of 37 minocycline and 38 placebo participants reported Grade 2 or higher toxicity and/or signs and symptoms during 48 weeks.||participants with an event|||Number
726404|NCT00361257|Secondary|Changes in Cluster of Differentiation 8 (CD8) Cell Counts (24 Weeks)|The outcome was the 24 week change of CD8 cell counts (week 24-baseline).|At baseline and week 24|The analysis was based on observed data.||cells/mm^3||Standard Deviation|Mean
726405|NCT00361257|Secondary|Changes in Cluster of Differentiation 4 (CD4) Cell Counts (24 Weeks)|The outcome was the 24 week change in CD4 cell count (week 24-baseline).|At baseline and weeks 24|The analysis was based on observed data.||cells/mm^3||Standard Deviation|Mean
726406|NCT00361257|Secondary|Change in Karnofsky Performance Score|"The original Karnofsky performance score is 11 level score which ranges between 0 to 100. The score 100 means normal and 0 means death; therefore, higher score means higher ability to perform daily tasks.
For the analysis, a new dichotomous variable (no change/worse vs. better at 24 weeks compared to baseline) was created."|At baseline and week 24|The analysis was based on observed data.||participants|||Number
726407|NCT00361257|Secondary|Change in Frontal Systems Function Domain Z-Score|The frontal systems function domain score is the average of age and education adjusted z scores of Stroop Color Interference Test (CTP) and interference task (STP). The outcome is the 24 week change of frontal systems function domain z-score (week 24-baseline).|At baseline and week 24|The analysis was based on observed data.||z-score||Standard Deviation|Mean
726408|NCT00361257|Secondary|Change in Verbal Memory Domain Z-Score|The verbal memory domain score is the average of age and education adjusted z scores of Hopkins Verbal Learning Test- Revised, Learning and Delayed Recall. The outcome is the 24 week change of verbal memory domain z-scores (week 24-baseline).|At baseline and week 24|The analysis was based on observed data.||z-score||Standard Deviation|Mean
726409|NCT00361257|Secondary|Change in Information Processing Function Domain Z-Score|The information processing function domain score is the average of age and education adjusted z scores of simple and sequential reaction time - CalCAP. The outcome is the 24 week change of information processing function domain z-scores (week 24-baseline).|At baseline and week 24|The analysis was based on observed data.||z-score||Standard Deviation|Mean
726410|NCT00361257|Secondary|Change in Fine Motor/Nonverbal Function Domain Z-Score|The fine motor/nonverbal function domain score is a age and education adjusted z score of Symbol Digit Test (SYD) The outcome is the 24 change of fine motor/nonverbal function domain z-score (week 24-baseline).|At baseline and week 24|The analysis was based on observed data.||z-score||Standard Deviation|Mean
726411|NCT00361257|Secondary|Change in Psychomotor Function Domain Z-Score|The psychomotor function domain score us the average of age, sex, education, and African-American ethnicity adjusted z scores of Trail Making Part A (TMA) and Trail Making Part B (TMB). The outcome is the 24 week change of psychomotor function domain z-scores (week24-baseline).|At baseline and week 24|The analysis was based on observed data.||z-score||Standard Deviation|Mean
726412|NCT00361257|Secondary|Change in Fine Motor Function Domain Z-Score|The fine motor function domain score is an average of age, sex, education, and African-American ethnicity adjusted z scores of Grooved Pegboard Dominant Hand (GPD) and Grooved Pegboard Non-dominant hand (GPN). The outcome is a 24 week change of the fine motor function domain z-score (week 24-baseline).|At baseline and week 24|The analysis was based on observed data.||z-score||Standard Deviation|Mean
726413|NCT00361257|Secondary|Change in Cognitive Gross Motor Function Domain Z-Score|The cognitive gross motor function is a age and education adjusted z score of Timed Gait (TIG). The outcome is the 24 week change of cognitive gross motor function domain z-scores (week 24-baseline).|At baseline and week 24|The analysis was based on the observed data.||z-score||Standard Deviation|Mean
726414|NCT00361257|Secondary|Change in Investigator's Clinical Global Impression Score (ICGIS)|"Clinicians were asked to rate their overall impression about the clinical improvement or worsening of his/her study participants. They can choose from the following 7 levels: (0) No Change, (1) Mild Improvement, (2) Moderate Improvement, (3) Marked Improvement, (4) Mild Worsening, (5) Moderate Worsening, and (6) Marked Worsening.
For the analysis, we simplified the outcome into the following 3 levels: (0) worsened, (1) No Change, and (2) Improved."|At week 24|The analysis was based on observed data.||participants|||Number
726415|NCT00361257|Secondary|Change in Global Deficit Z-Score (GDS)|GDS on the test battery is the simple average of all 14 individual deficit scores in the test battery, including Time Gait, Grooved Pegboard Test for the dominant and non-dominant hands, Trail Making Test parts A and B, Symbol Digit Test, simple and sequential reaction time - CalCAP, Hopkins Verbal Learning Test (Revised)- Learning, Delayed Recall and Recognition trials, and Stroop Color Interference Test-color, word, and interference tasks. The outcome is the 24 week change of GDS Z-score (24 week-baseline).|At baseline and week 24|The analysis was based on the observed data.||z-score||Standard Deviation|Mean
726416|NCT00361257|Primary|Change in Cognitive Performance Compared to Baseline|"Th cognitive performance is measured by NPZ-8. NPZ-8 is defined as the average of age and education adjusted z-scores of eight neuropsychological tests subcomponents in the neuropsychological test battery. These eight tests are:
Grooved Pegboard Dominant Hand (GPD)
Grooved Pegboard Non-dominant hand (GPN)
Choice Reaction Time (CRT)
Sequential Reaction Time (QRT)
Timed Gait (TIG)
Trail Making Part A (TMA)
Trail Making Part B (TMB)
Symbol Digit (SYD) The primary outcome is NPZ-8 score at week24 - NPZ-8 score at baseline."|At baseline and week 24|The descriptive statistics above were based on the observed data; however, the statistical analysis was conducted by the ITT analysis and the missing outcomes at week 24 were imputed based on multiple regression imputations.||z-score||Standard Deviation|Mean
726417|NCT00361270|Secondary|Change From Pre Treatment to 1-week Post Treatment on Pittsburgh Sleep Quality Index (PSQI)|The change score is the difference between pre-treatment scores on the Pittsburgh Sleep Quality Index (PSQI) and the 1-week post-treatment scores. Positive values indicate a reduction in sleep problems. The PSQI was scored on 19 items with 7 component scores ranging from 0 no difficulty falling asleep to 3 severe difficulty, then component scores added to create global score ranging from 0 no difficulty falling asleep to 21 severe difficulty falling asleep.|Subjects change on this scale from Pre-treatment to 1-week post treatment|||units on a scale||Standard Deviation|Mean
726418|NCT00361270|Secondary|Change From Pre-treatment to 1- Week Post Treatment on Brief Pain Inventory-Interference Scale|The change score measures the difference between pre-treatment scores on the Brief Pain Inventory-Interference Scale (NRS: 0 no interference - 10 complete interference) and 1- week post treatment scores for the 10 items. Change is calculated as pre-treatment minus post treatment.|Subjects change on this scale from Pre-Treatment to 1-week post treatment|||units on a scale||Standard Deviation|Mean
726419|NCT00361270|Primary|Change From Pre-Treatment to 1-week Post Treatment on Brief Pain Inventory-Pain Intensity Scale|The change score measures the difference between Pre-Treatment Brief Pain Inventory Pain Intensity Scale scores (Numerical Rating Scale (NRS): 0 no pain - 10 worst pain) and the 1-week Post--Treatment Brief Pain Inventory-Pain Intensity Scale scores for 4 items. Change is calculated as pre-treatment minus post treatment.|Subjects change on this scale from Pre-Treatment to 1 week post treatment|||units on a scale||Standard Deviation|Mean
726420|NCT00361283|Primary|Mean Change in Level: Week 16-baseline in Ena-78|We take difference week 16 minus week 0 for ENA-78 and use a one sample t comparison.|16 weeks after baseline|Power calculation||pg/ml||Standard Deviation|Mean
726421|NCT00361335|Secondary|Physical Component Summary (PCS) Score of the Short Form-36 (SF-36) at Week 14|The SF-36 consists of 8 multi-item scales: limitations in physical functioning due to health problems, usual role activities due to physical health problems, bodily pain, usual role activities due to personal or emotional problems, social functioning due to physical or mental health problems, general mental health (psychological distress and well-being), vitality and general health perception. The values are 100=best to 0=worst.|Weeks 0 to Week 14|Intent to treat (ITT). Missing components were imputed by the median component value of all patients in the same Stratum at baseline, and last observation carried forward (LOCF) at Week 14||Units on a scale||Standard Deviation|Mean
726422|NCT00361335|Secondary|Number of Participants With a Disease Activity Index Score 28 (Using C-reactive Protein)Moderate or Good Response at Week 14|"DAS28 using CRP is a measure of tender and swollen joints (28 joints each) and the patient’s assessment of disease activity. Values range from 0 (best) to 10 (worst). A score of higher than 5.1 indicates high disease activity, and a score below 3.2 indicates low disease activity. A Good response is defined as a patient with a DAS28 score of <= 3.2 at Week 14 with improvement from Baseline in DAS28 score of > 1.2. A “Moderate” response is defined as a patient with DAS28 score of >3.2-5.1 at Week 14 with improvement from baseline in DAS28 score of >1.2 or a DAS28 score of <= 5.1 and improvement from baseline in DAS28 score of >0.6 to 1.2"|Week 0 to Week 14|Intent to treat. Patients considered non-responder if used any pre-specified prohibited medications or discontinued subcutaneous (SC) study agent due to lack of efficacy. Missing components were imputed by the median component value of all patients in the same stratum unless all components are missing in which case considered non-responders.||Participants|||Number
726423|NCT00361335|Secondary|Number of Participants With an American College of Rheumatology (ACR) 20 Response at Week 14|ACR 20 response is an improvement of greater than or equal to 20 percentage from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (patient's assessment of pain, patient's global assessemnt of disease activity, Physician's global assessment of disease activity [based on a scale of 0=no disease to 10=severe disease), HAQ (20 questions on life activities] and CRP blood test to measure inflammation).|Week 0 to Week 14|Intent to treat (ITT). Patients considered non-responder if used any pre-specified prohibited medications or discontinued subcutaneous (SC) study agent due to lack of efficacy. Missing ACR components were imputed by Last Observation Carried Forward (LOCF) unless all ACR components are missing in which case considered non-responders.||Participants|||Number
726424|NCT00361335|Secondary|Number of Participants With an American College of Rheumatology (ACR) 50 Response at Week 24|ACR 50 response is an improvement of greater than or equal to 50 percentage from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (patient's assessment of pain, patient's global assessemnt of disease activity, Physician's global assessment of disease activity (based on a scale of 0=no disease to 10=severe disease), HAQ (20 questions on life activities) and CRP blood test to measure inflammation).|Week 0 to Week 24|||Participants|||Number
726425|NCT00361335|Primary|Number of Participants With an American College of Rheumatology (ACR) 50 Response at Week 14|An ACR 50 response is defined as a greater than or equal to 50 percentage improvement from baseline in: 1. Swollen joint count (66 joints) and tender joint count (68 joints) 2. greater than or equal to 50 percentage improvement in 3 of the following 5 assessments: a. Patient's assessment of pain (VAS) (0-10 cm) b. Patient's Global Assessment of Disease activity (VAS) (0-10 cm) c. Physician's Global Assessment of Disease Activity (VAS) (0-10 cm) d. Patient's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C reactive protein (CRP).|Week 0 to Week 14|Intent to treat (ITT). Patients considered non-responder if used any pre-specified prohibited medications or discontinued subcutaneous (SC) study agent due to lack of efficacy. Missing ACR components were imputed by Last Observation Carried Forward (LOCF) unless all ACR components are missing in which case considered non-responders.||Participants|||Number
727611|NCT00377312|Primary|Total Serum Calcium|mg/dl|12 hours after the infusion was started then q 8 hours for 7 days, Follow-up 1 week after infusion complete|||mg/dl||Standard Error|Mean
726426|NCT00361374|Primary|Score on a Depression Severity Rating Scale Over Eight Weeks|Change in score on 17-item Hamilton D depression severity rating scale over 8 weeks of treatment. Scores were obtained every 2 weeks for 8 weeks. The total sum score of the 17 items is used to assess depressive severity. Possible total scores range from 0-52, with a higher score indicating greater depressive severity. Scores of 7 or less are indicative of full remission (i.e. no depression). Scores of 8-15 indicate mild depression; scores of 16-25 indicate moderate depression; scores of 25 or greater indicate severe depression. Mixed model repeated measures analysis (MMRM) was used to examine treatment group effect on changes from baseline to week 8 in Hamilton D scores. Models included subjects as a random effect, and treatment group and study week as fixed effects. An auto-regressive covariance structure was used because it provided the best fit to the data. Site and baseline score were included as covariates in all models.|8 weeks|We randomized 196 of 389 screened patients. Nineteen subjects dropped out before completing at least one post-baseline visit, leaving 177 evaluable subjects||units on a scale||Standard Error|Mean
726427|NCT00361439|Secondary|Change From Baseline in Percentage of Eosinophils at 2 Weeks|"A decrease between visits signifies a reduction in inflammation.
Calculated from cytology specimens obtained by lavage."|baseline and 2 weeks|||percentage of eosinophils||Full Range|Median
726428|NCT00361439|Secondary|Change From Baseline in Nasal Peak Inspiratory Flow at 2 Weeks|An increase between visits indicates improved nasal airflow.|baseline and 2 weeks|||liters per minute||Full Range|Median
726429|NCT00361439|Secondary|Change From Baseline in Total Nasal Symptom Score at 2 Weeks|A decrease in scores between visits signifies an improvement in nasal symptoms. The total nasal symptom score can range from 0 to 27.|baseline and 2 weeks|||units on a scale||Full Range|Median
726430|NCT00361439|Primary|Histological Findings|Number of eosinophils per high-powered field (HPF) in olfactory biopsy taken after 2 weeks of study treatment (higher values indicate greater inflammation); average of three HPF reported|2 weeks|||eosinophils per HPF||Full Range|Median
726431|NCT00361504|Secondary|Change From Baseline in Average Pain Intensity Scores at Week 52 Using the Numerical Rating Scale (NRS)|"The Participants indicated the average level of pain experienced, at each study visit, over the previous 24 hours on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. Baseline was the average pain intensity scores measured prior to randomization (At Week 1). At Week 52 again the average pain intensity scores were collected and the change in scores at Week 52 from the baseline scores was considered as the change from baseline in average pain intensity scores at Week 52."|Baseline, Week 52|intent-to-treat||Scores on a Scale||Standard Deviation|Mean
726432|NCT00361504|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAE)|The number of participants who reported a TEAE during the treatment period. TEAE was defined as any adverse event that started or worsened on or after the start of the study medication and up to 3 days after the discontinuation of the study medication.|52 weeks|Safety analysis set (All randomized participants who took at least one dose of study medication).||Participants|||Number
726433|NCT00363415|Post-Hoc|Number of Participants in Subgroups: LDH<=Upper Limit of Normal and History of Brain Metastases=Yes|Number of participants with Low Density Lipoprotein <=upper limit of normal and the number of participants with a history of brain metastases. This post-hoc outcome replaces the one for Overall Survival (Subgroups: LDH<=Upper Limit of Normal and History of Brain Metastases=Yes).|baseline to date of death due to any cause (up to 19.6 months)|Number of randomized participants.||participants|||Number
726434|NCT00363415|Secondary|Overall Survival (Subgroups: LDH<=Upper Limit of Normal and History of Brain Metastases=Yes)|The effects of individual baseline factors (lactate dehydrogenase (LDH) and history of brain metastases) on overall survival are reported. The Upper Limits of the 95% Confidence Intervals were not calculable for these factors in the Etoposide+Carboplatin group. The number of participants in these subgroup are instead presented as a Post-Hoc Outcome Measure.|baseline to date of death due to any cause (up to 19.6 months)|The upper limit of the 95% Confidence Intervals (CI) were not calculable for these two subgroups in the etoposide+carboplatin group so medians and lower limits of the 95% CI are not presented. A post-hoc outcome measure table provides the number of participants in each subgroup.||months||95% Confidence Interval|Median
726435|NCT00363415|Secondary|Change From Baseline to Each Cycle in Functional Assessment of Cancer Therapy – Lung (FACT-L)|FACT-L measures following domains of health-related quality of life (HR-QL): physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns of lung cancer. Total scores range from 0 to 136, with higher scores representing better HR-QL. A clinically meaningful change is considered to be 5 points.|baseline and 6 cycles (21-day cycles)|Number of randomized participants with baseline and non-missing value at respective cycle.||units on a scale||Standard Deviation|Mean
726436|NCT00363415|Secondary|Progression Free Survival|The period from study entry until disease progression, death or date of last contact.|baseline to measured progressive disease (up to 14.7 months)|All randomized participants. Number of participants censored: 113 in Pemetrexed+Carboplatin; 150 in Etoposide+Carboplatin.||months||95% Confidence Interval|Median
726437|NCT00363415|Secondary|Overall Survival (Subgroups)|The effects of individual baseline factors (sex, race, Eastern Cooperative Oncology Group (ECOG) performance, region, lactate dehydrogenase (LDH), age, number of metastatic sites, and history of brain metastases) on overall survival are reported. For two subgroups - LDH<=upper limit of normal and brain metastases=yes, the upper limits of the 95% confidence interval were not calculable for the etoposide+carboplatin group - instead the number of participants in these two subgroups are presented as a post-hoc outcome measure.|baseline to date of death from any cause (up to 19.6 months)|Number of randomized participants.||months||95% Confidence Interval|Median
726438|NCT00363415|Primary|Overall Survival|Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.|baseline to date of death from any cause (up to 19.6 months)|Number of participants with events. In the pemetrexed+carboplatin group, 242 participants were censored. In the etoposide+carboplatin group, 288 participants were censored.||months||95% Confidence Interval|Median
726439|NCT00363467|Secondary|1 Year Overall Survival|Number of participants alive at 1 year posttransplant|1 year post transplant|||participants|||Number
726440|NCT00363467|Secondary|1 Year Event-free Survival|Number of participants alive and without disease relapse at 1 year posttransplant|1 year post transplant|||participants|||Number
726444|NCT00363545|Secondary|Number of Subjects With Rotavirus in Stool Samples Collected During Gastroenteritis Episodes|The number of subjects with rotavirus (vaccine strain or wild-type rotavirus) in stool samples collected during gastroenteritis episodes from the first dose (Dose 1) of Rotarix™ vaccine up to Visit 3, as follows: between Dose 1 and before Dose 2, between Dose 2 and Visit 3 and between Dose 1 and Visit 3.|From the first vaccine dose (Dose 1) up to Month 4|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one study vaccine administration documented and with symptoms sheet filled in.||Subjects|||Number
726445|NCT00363545|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Throughout the entire study period (from Day 0 to Month 4)|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one study vaccine administration documented.||Subjects|||Number
726446|NCT00363545|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within 31 days after any vaccine dose (Day 0-30)|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one study vaccine administration documented.||Subjects|||Number
726447|NCT00363545|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were cough/runny nose, diarrhea, fever [defined as rectal temperature equal to or above 38 degrees Celsius (°C)], irritability/fussiness (Irr./Fuss.), loss of appetite and vomiting. Any = occurrence of the symptom regardless of intensity grade. Grade 3 cough/runny nose = cough/runny nose that prevented normal activity. Grade 3 diarrhea = 6 or more than (≥) 6 looser than normal stools/day. Grade 3 irritability/fussiness (Irr./Fuss.) = crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 vomiting = 3 or more than (≥) 3 episodes of vomiting/day. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 15-day (Day 0-14) follow-up period, after each vaccine dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one study vaccine administration documented and with symptoms sheet filled in.||Subjects|||Number
726448|NCT00363545|Secondary|Number of Subjects With Vaccine Take for Anti-rotavirus IgA Antibodies|Vaccine take was defined as appearance of serum anti-rotavirus IgA antibodies in post-vaccination sera at a concentration of ≥ 20 U/mL and/or vaccine virus excretion in any stool sample collected from Day 0 to Month 4, for subjects initially negative for rotavirus. The analysis was performed on the stool analysis subset, which included 100 subjects per group.|At 1 to 2 months after the second vaccine dose (Months 3-4)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at post-sampling time point.||Subjects|||Number
726449|NCT00363545|Secondary|Concentrations of Anti-rotavirus IgA Antibodies|Anti-rotavirus IgA antibody concentrations assessed by using the Enzyme-Linked Immunosorbent Assay (ELISA) are presented as geometric mean concentrations (GMCs), expressed in units per milliliter (U/mL).|At 1 to 2 months after the second vaccine dose (Months 3-4)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at post-sampling time point.||U/mL||95% Confidence Interval|Geometric Mean
726450|NCT00363545|Primary|Number of Seroconverted Subjects Against Human Rotavirus|A seroconverted subject was defined as a vaccinated subject who had an anti-rotavirus IgA antibody concentration equal to or above (≥) 20 units per milliliter (U/mL) and who was initially (i.e. prior to the first dose of Rotarix™ vaccine) negative for rotavirus.|At 1 to 2 months after the second vaccine dose (Months 3-4)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at post-sampling time point.||Subjects|||Number
726451|NCT00363675|Primary|Moberg Pickup Test|The child picks up 12 small objects such as a coin, safety pin and paper clip one at a time and puts them in a container. The time in seconds to complete the task is the score.|Seconds to pick up all 12 objects|A convenience sample was planned for this study.||Seconds||Full Range|Median
726452|NCT00363675|Primary|Grip Strength|This is a measure of grip strength in pounds using a dynamometer. The subject squeezes the dynamometer as hard as possible for three trials separated by a short rest. The mean of the three trials is the score.|Baseline|Convenience sample was planned for this study.||Pounds||Full Range|Median
726453|NCT00363675|Primary|Range of Motion, Total Active Motion (TAM)|Subjects' degrees of hand motion are measured by a trained therapist and recorded. Total Active Motion is a measure of finger range of motion that can be used to predict functional movement of the hand. The TAM is the sum of the degrees of active motion of each of the three joints of the fingers, and two joints of the thumb. For this study we also included wrist motion. Full TAM is 1,455 degrees of motion.|Baseline|Convenience sample was planned for ths study.||Degrees||Full Range|Median
726454|NCT00363675|Primary|Blocks & Box (Standardized Test).|Children are asked to move as many blocks as possible from one box to another in one minute. The number of blocks moved is the score.|Baseline|Convenience sample was planned for this study.||Blocks||Full Range|Median
726455|NCT00363779|Secondary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|3 months|||Participants|||Number
726456|NCT00363779|Primary|Changes in Gene Expression Patterns|The goal was to examine which genes had a 2-fold gene expression between pre-treatment (baseline) and post treatment (12 weeks). Genes significant at the 0.001 level will be considered as differentially expressed due to treatment.|Baseline and 12 weeks|This outcome measure was not performed because there were insufficient data points to provide any statistical power.|||||
726470|NCT00364013|Secondary|Overall Survival|The definition of overall survival is the time from randomization to death; participants who were alive at the analysis data cutoff were censored at their last contact date.|From randomization until the data cutoff date of 28 August 2009. Maximum time on follow-up was 153 weeks.|KRAS Efficacy Analysis Set||months||95% Confidence Interval|Median
726457|NCT00363805|Primary|Change in Urinary 8-F2-isoprostanes Levels|the urinary concentrations of 8-F2-isoprostanes were normalized by the urinary creatinine concentrations to correct for variations in urine dilution/production and the change in urinary 8-F2-isoprostanes levels was calculated as 6 months levels minus baseline levels|Baseline and 6 months|The number of participants analyzed was less than the number of participants completing the study because the analysis only included samples where the identity of the analyte was confirmed in the sample.||ng/mg creatinine||Standard Deviation|Mean
726458|NCT00363805|Primary|Change in Urinary 8-hydroxydeoxyguanosine Levels|the urinary concentrations of 8-hydroxydeoxyguanosine were normalized by the urinary creatinine concentrations to correct for variations in urine dilution/production and the change in urinary 8-hydroxydeoxyguanosine levels was calculated as the 6 months levels minus the baseline levels|Baseline and 6 months|The number of participants analyzed was less than the number of participants completing the study because the analysis only included samples where the identify of the analyte was confirmed in the sample.||ng/mg creatinine||Standard Deviation|Least Squares Mean
726459|NCT00363883|Secondary|Progression-free Survial|Will be estimated using the product-limit method of Kaplan and Meier. Progression defined using RECIST v1.0 criteria, at least a 20% increase in the sum of the longest diameter of target lesions, or the appearance of one or more new lesions.|assessed up to 26 weeks|||months||95% Confidence Interval|Median
726460|NCT00363883|Secondary|Overall Survival|Will be estimated using the product-limit method of Kaplan and Meier.|Up to 26 weeks|||months||95% Confidence Interval|Median
726461|NCT00363883|Primary|Objective Tumor Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Response assessed after every 2 cycles (6 weeks) up to 26 weeks|||percentage of patients|||Number
726462|NCT00363896|Primary|Trough Forced Expiratory Volume in the First Second (FEV1) (L) at 12 Weeks on Treatment|Trough FEV1 (mean of two highest FEV1 values assessed at 23 and 24 hours after inhalation) at 12 weeks|Week 12|Intention-to-Treat (ITT) population: all randomised patients who took at least one dose of Investigational Medicinal Product and had at least the baseline and one post-baseline value available for the primary efficacy variable.||Liters||Standard Error|Least Squares Mean
726463|NCT00363896|Secondary|Percentage of Patients Who Achieved at Least a 4-unit Decrease From Baseline in the SGRQ Total Score at 52 Weeks on Treatment|Percentage of patients who achieved a clinically relevant improvement in health-related quality of life at 52 weeks, as measured by at least a 4-unit decrease from baseline in St George's Respiratory Questionnaire (SGRQ) total score|52 weeks|Intention-to-Treat (ITT) population: all randomised patients who took at least one dose of Investigational Medicinal Product and had at least the baseline and one post-baseline value available for the primary efficacy variable.||Percentage of Patients|||Number
726464|NCT00363896|Secondary|Time to First Moderate or Severe COPD Exacerbation at 52 Weeks on Treatment|"Time to first moderate or severe exacerbation:
Increase of COPD symptoms during at least 2 consecutive days, treated with antibiotics and/or systemic corticosteroids or an increase in dose of systemic corticosteroids, or leading to hospitalisation."|Week 52|Intention-to-Treat (ITT) population: all randomised patients who took at least one dose of Investigational Medicinal Product and had at least the baseline and one post-baseline value available for the primary efficacy variable.||Days||95% Confidence Interval|Median
726465|NCT00363896|Primary|Trough FEV1 (L) at 28 Weeks on Treatment|Trough FEV1 (mean of two highest FEV1 values assessed at 23 and 24 hours after inhalation) at 28 weeks|Week 28|Intention-to-Treat (ITT) population: all randomised patients who took at least one dose of Investigational Medicinal Product and had at least the baseline and one post-baseline value available for the primary efficacy variable.||Liters||Standard Error|Least Squares Mean
726466|NCT00364013|Secondary|Number of Participants With Adverse Events (AEs)|"A serious adverse event (SAE) is defined as an AE that • is fatal • is life threatening • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • other significant medical hazard. The relationship of the adverse event to the study treatment was assessed by the Investigator by means of the question: “Is there a reasonable possibility that the event may have been caused by the study treatment?"|From randomization until the data cut-off date of 28 August 2009; Maximum time on follow-up was 153 weeks.|Safety analysis set; One participant was randomized to 'Panitumumab Plus FOLFOX’, but received ‘FOLFOX Alone’ so is counted in that group.||participants|||Number
726467|NCT00364013|Secondary|Duration of Response|Duration of response was calculated only for those participants with a confirmed CR or PR, as the time from the first CR or PR (subsequently confirmed within no less than 4 weeks) to first observed disease progression per modified RECIST criteria, based on a blinded central review.|Every 8 weeks until disease progression up to the data cut-off date of 30 September 2008; Maximum follow-up time was 109 weeks.|KRAS Evaluable Central Tumor Response Analysis Set: Responders||months||95% Confidence Interval|Median
726468|NCT00364013|Secondary|Time to Progression|Time to progression was defined as time from randomization date to date of disease progression per the modified RECIST criteria.|From randomization until the data cut-off date of 30 September 2008; Maximum follow-up time was 109 weeks.|KRAS Efficacy Analysis Set||months||95% Confidence Interval|Median
726469|NCT00364013|Secondary|Percentage of Participants With an Objective Response|Participants were evaluated for tumor response per the modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria every 8 weeks until disease progression. Objective response by central radiological assessment was defined as the incidence of either a confirmed complete or partial response (CR or PR) while on the first-line treatment, as determined by blinded independent central review and confirmed no less than 4-weeks after the criteria for response are first met. CR: Disappearance of all target and non-target lesions and no new lesions. PR: At least a 30% decrease in the sum of the longest diameter of target lesions and no progression of non-target or no new lesions, or, disappearance of all target lesions and the persistence of ≥ 1 non-target lesion not qualifying for either CR or progressive disease. Participants without a post-baseline assessment were considered non-responders.|Every 8 weeks until disease progression up to the data cut-off date of 30 September 2008; Maximum follow-up time was 109 weeks.|KRAS Evaluable Central Tumor Response Analysis Set (subset of participants with at least one uni-dimensionally measurable lesion per the modified RECIST criteria per blinded central radiology review).||percentage of participants||95% Confidence Interval|Number
726471|NCT00364013|Primary|Progression-free Survival|Progression-free survival (PFS), assessed by central radiological assessment, was defined as the time from randomization to disease progression per modified response evaluation criteria in solid tumors (RECIST) criteria or death. Participants who were alive but did not meet criteria for progression by the data cutoff date were censored at their last evaluable disease assessment date. Progressive disease is defined as a ≥ 20% increase in the size of target lesions or unequivocal progression of existing non-target lesions or any new lesions.|From randomization until the data cutoff date of 30 September 2008. Maximum follow-up time was 109 weeks.|KRAS Efficacy Analysis Set (participants for whom KRAS status was assessed)||months||95% Confidence Interval|Median
726472|NCT00364130|Secondary|Change in QCT Tibia Trabecular Volumetric BMD at 12 Months|We calculated the mean change in tibia trabecular volumetric BMDbetween baseline and 12 months as measured by (QCT)|12 months|||cm^3||Standard Deviation|Mean
726473|NCT00364130|Secondary|Change in Whole Body Bone Mineral Content Z-score Between Baseline and 12 Months|We calculated the mean change in whole body bone mineral content Z-score, as measured by DXA, between baseline and 12 months|12 months|||Z-score||Standard Deviation|Mean
726474|NCT00364130|Secondary|Change in Femoral Neck Areal BMD Z-score Between Baseline and 12 Months|We calculated the mean change in femoral neck areal bmd Z-score between baseline and 12 months as measured by DXA|12 months|||Z-score||Standard Deviation|Mean
726475|NCT00364130|Secondary|Change in Total Hip Areal BMD Z-score Between Baseline and 12 Months|We calculated the mean change in total hip bone mineral density z-score, as measured by DXA, between baseline and 12 months|12months|||Z-score||Standard Deviation|Mean
726476|NCT00364130|Secondary|Change in Posteroanterior Lumbar Spine Areal BMD Z-score|We calculated the mean change in posterior anterior lumbar spine areal BMD Z-score between baseline and 12 months as measured by DXA|12 months|||Z-score||Standard Deviation|Mean
726477|NCT00364130|Primary|Change in Spine Volumetric BMD Z-score at 12 Months|We calculated the mean change in spine volumetric BMD Z-score, as measured by QCT, between baseline and 12 months|12 months|The number was determined by the number of participants with measures at both baseline and 12 month time points. The analysis was intention to treat.||Z-score||Standard Deviation|Mean
726478|NCT00364130|Primary|Change in Tibia Cortical Area Z-score 12 Months|We calculated the mean change in tibia cortical area Z-score, as measured by pQCT, between baseline and 12 months.|12 months|The number was determined by the number of participants with measures at both baseline and 12 month time points. The analysis was intention to treat.||Z-score||Standard Deviation|Mean
726479|NCT00364130|Primary|Change in Tibia Trabecular Volumetric Bone Mineral Density (BMD) Z-score at 12 Months|"We calculated the mean change in tibia trabecular volumetric BMD Z-score between baseline and 12 months, as measured by peripheral quantitative computed tomography (pQCT).
The Z-score, or Standard Deviation Score, is a measure of the number of standard deviations that an individual is above or below the median value in a healthy child or adolescent of the same age, sex and race. For example, a Z-score of 0 means that an individual's result is equivalent to the 50th percentile in a healthy population. A Z-score of -1.0 means that an individual's result is equovalent to the 16th percentile in a healthy population."|12 months|The number was determined by the number of participants with measures at both baseline and 12 month time points. The analysis was intention to treat.||Z-score||Standard Deviation|Mean
726480|NCT00364156|Primary|Biochemically Verified 7-day Point Prevalence Abstinence|To evaluate the efficacy of standard (8-week) vs. extended (24-week) transdermal nicotine therapy.|End of Treatment (week 24)|Intention to Treat analysis (ITT)||Participants|||Number
726481|NCT00364182|Secondary|36-Item Short-Form Health Survey (SF-36): Physical Functioning Domain|SF-36: standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, and mental health. The physical functioning domain score was an average of the individual physical functioning question scores across all time points, which was scaled 0-100 (100=highest level of functioning).|Weeks 16, 32, and 56|ITT; N=number of participants with evaluable data.||units on a scale||Standard Deviation|Mean
726482|NCT00364182|Secondary|HRPQ Score: Hours Lost From Work or School at 48 Hours Post-bleed|HRPQ: self-reported scale that measured for each bleed event, hours lost from work, school and housework because of hemophilia and its treatments. Mean and standard deviations calculated from measured values.|48 hours post-bleed|ITT||hours||Standard Deviation|Mean
726483|NCT00364182|Secondary|Health-Related Productivity Questionnaire (HRPQ) Score: Hours Lost From Work or School at 24 Hours Post-bleed|HRPQ: self-reported scale that measured for each bleed event, hours lost from work, school and housework because of hemophilia and its treatments. Mean and standard deviations calculated from measured values.|24 hours post-bleed|ITT||hours||Standard Deviation|Mean
726484|NCT00364182|Secondary|Acute Pain After Hemarthrosis|For each bleeding event, a diary was filled out that night and the subsequent night and included a Brief Pain Inventory (BPI): self-reported scale that measured severity of pain experienced over the past 24 hours. Questions included How much pain right now? 0 (no pain) to 10 (pain as severe as you can imagine).|24 and 48 hours post-bleed|ITT||units on a scale||Standard Deviation|Mean
726485|NCT00364182|Secondary|Quality of Sleep Measured by Sleep Diary After Hemarthrosis|For each bleeding event, a diary was filled out that night and the subsequent night. Questions included: How would you describe the quality of your sleep last night? 1=Very Good, 2=Good, 3=Fair, 4=Poor, 5=Very Poor. Reported as quality of sleep during study.|24 and 48 hours post-bleed|ITT||Units on a scale||Standard Deviation|Mean
726486|NCT00364182|Secondary|Amount of Sleep Measured by Sleep Diary After Hemarthrosis|For each bleeding event, a diary was filled out that night and the subsequent night. Questions included: How long do you think you slept last night? Reported as average duration of sleep during study.|24 and 48 hours post-bleed|ITT||hours||Standard Deviation|Mean
726487|NCT00364182|Primary|Annualized Number of Bleeding Episodes|Annualized bleed rate (ABR) or number of bleeds per year derived for each participant for each treatment regimen by using the following formula: ABR = number of bleeds / (days on treatment regimen / 365.25)|Baseline up to Week 56|Intention-to-treat (ITT) population: all enrolled participants||episodes||95% Confidence Interval|Least Squares Mean
726539|NCT00364819|Primary|Number of Participants With Adverse Events||52 weeks|||Participants|||Count of Participants
726666|NCT00365599|Secondary|Number of Participants With Serious Adverse Events (SAEs)|Safety evaluation according to descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|4 years, 7 months|All participants||participants|||Number
726488|NCT00364286|Primary|Participants With Objective Response|Number of participants with an Objective Response defined as Complete Response (CR) or Partial Response (PR). Responses evaluated every 3 months +/- 1 week by each component and overall by National Cancer Institute Working Group (NCIWG) criteria where Response judged, Nodes for CR: None; PR: > 50% decrease; Liver/Spleen CR: Not palpable; PR: > 50% decrease; Symptoms for CR: None; PR: Not applicable (N/A); polymorphonuclear leukocyte (PMN) for CR: >1,500/μl, PR: > 1,500/μl or >50% improvement from baseline; Platelets for CR: >100,000/μl, PR: >100,000/μl or > 50% improvement from baseline; Hemoglobin (untransfused) for CR: >11,0 g/dl; PR: >11.0 g/dl or >50% improvement from baseline; Lymphocytes for CR: <4,000/μl and PR: >50% decrease; Bone Marrow aspirate for CR: <30% lymphocytes, N/A for PR; Bone Biopsy for CR: No lymphocyte infiltrate; PR: < 30% lymphocytes with residual disease on biopsy for nodular PR.|4 week treatment cycle|Three participants were not evaluable for response due to early discontinuation of treatment (0-3 days).||Participants|||Number
726489|NCT00364351|Secondary|Time to Deterioration of Disease-related Symptoms (TDS) by EORTC Quality of Life Questionnaire - Cough|"Cough was assessed using Question 1 (How much did you cough) of the QLQ-LC13 (or, equivalently, Question 31 of the combined QLQ-C30 and QLQ-LC13 questionnaires).
Time to deterioration in symptoms is defined as the interval from the date of randomization to the first assessment of worsened without an improvement in the next 28 days. A patient is defined as having a deterioration in symptoms if they have a single visit assessment of ‘worsened’ with no visit assessment of ‘improved’ within the next 28 days."|Disease-related symptom assessments are to be administered at screening (within 7 days before the first dose of study medication), every 4 weeks thereafter, at discontinuation of study treatment and at the 30-day follow-up visit|||Weeks||Inter-Quartile Range|Median
726490|NCT00364351|Secondary|Time to Deterioration of Disease-related Symptoms (TDS) by EORTC Quality of Life Questionnaire - Dyspnoea|"Dyspnea was assessed as the average score of four items: Question 8 of the QLQ-C30 (Were you short of breath) and Question 3 of the QLQ-C30 (Were you short of breath when you rested), Questions 4 (Were you short of breath when you walked) and 5 (Were you short of breath when you climbed stairs) of the QLQ-LC13 (or, equivalently, Questions 33, 34 and 35 of the combined QLQ-C30 and QLQ-LC13 questionnaires).
Time to deterioration in symptoms is defined as the interval from the date of randomization to the first assessment of worsened without an improvement in the next 28 days. A patient is defined as having a deterioration in symptoms if they have a single visit assessment of ‘worsened’ with no visit assessment of ‘improved’ within the next 28 days."|Disease-related symptom assessments are to be administered at screening (within 7 days before the first dose of study medication), every 4 weeks thereafter, at discontinuation of study treatment and at the 30-day follow-up visit|||Weeks||Inter-Quartile Range|Median
726491|NCT00364351|Secondary|Time to Deterioration of Disease-related Symptoms (TDS) by EORTC Quality of Life Questionnaire - Pain|"Pain was assessed as the average score of two items: Question 9 (Have you had pain) and 19 (Did pain interfere with your daily activities) of the QLQ-C30.
Time to deterioration in symptoms is defined as the interval from the date of randomization to the first assessment of worsened without an improvement in the next 28 days. A patient is defined as having a deterioration in symptoms if they have a single visit assessment of ‘worsened’ with no visit assessment of ‘improved’ within the next 28 days."|Disease-related symptom assessments are to be administered at screening (within 7 days before the first dose of study medication), every 4 weeks thereafter, at discontinuation of study treatment and at the 30-day follow-up visit|||Weeks||Inter-Quartile Range|Median
726492|NCT00364351|Secondary|Disease Control Rate (DCR)|Disease control rate is defined as the number of patients who achieved disease control at least 8 weeks following randomisation. Disease control is defined as a best objective response of complete response (CR), partial response (PR) or stable disease (SD) >= 8 weeks as determined according to RECIST 1.0. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere, PR is defined as at least a 30% reduction in the total tumour size of measurable lesions with no new lesions and no progression in the non-target lesions and SD >= 8 is assigned to patients who have not responded and have no evidence of progression at least 8 weeks after randomisation.|RECIST tumour assessments carried out every 4 weeks until week 16 then every 8 weeks thereafter (+/- 3 days) from randomisation until objective progression|||Participants|||Number
726493|NCT00364351|Secondary|Objective Response Rate (ORR)|The ORR is the number of patients that are responders ie those patients with a confirmed best objective response of complete response (CR) or partial response (PR) as determined according to RECIST 1.0. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere and PR is defined as at least a 30% reduction in the total tumour size of measurable lesions with no new lesions and no progression in the non-target lesions.|RECIST tumour assessments every 4 weeks up to week 16 then every 8 weeks thereafter from randomisation until the date of first documented objective disease progression or date of death from any cause, whichever came first, assessed up to 21 months|||Participants|||Number
726494|NCT00364351|Secondary|Overall Survival (OS)|Overall survival is defined as the time from date of randomization until death. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive (ie their status must be known at the censored date and should not be lost to follow up or unknown).|Time to death in months|||Months||Full Range|Median
726495|NCT00364351|Primary|Progression-Free Survival (PFS)|"Median time (in weeks) from randomisation until objective disease progression or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable Response Evaluation Criteria In Solid Tumors (RECIST) assessment.
Progression was derived according to RECIST 1.0 and is defined as an increase of at least 20% in the total tumour size of measurable lesions over the nadir measurement, unequivocal progression in the non-target lesions or the appearance of one or more new lesions."|progressionRECIST tumour assessments carried out every 4 weeks up to week 16 then every 8 weeks thereafter from randomisation until the date of first documented objective disease progression or date of death from any cause, whichever came first, assessed.|||Weeks||Full Range|Median
726496|NCT00364377|Primary|Lowering of Fasting Glucose|fasting glucose taken as the mean of blood glucose measured at -30, -20, -10 and 0 minutes prior to each inpatient meal study|8 weeks|Analysis was per protocol - all participants completed the intervention||mmol/l||Standard Error|Mean
726667|NCT00365599|Secondary|Time to Progression (TTP)|The median response duration in months. Response and progression were evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST).|Up to 30 months|All participants||months||Full Range|Median
726497|NCT00364533|Secondary|The SPID at 12, 24, and 72 Hours Relative to First Dose.|The SPID score incorporates the cumulative analgesic effects of tapentadol IR on pain intensity over an extended period (12 to 72 hours) allowing for an evaluation of multiple doses of drug, even when dosing frequency may vary. Scoring is derived from the Numerical Rating Scale (NRS) from 0 = No pain to 11 = Pain as bad as you can imagine.|3 days|Due to termination of trial, results were not analyzed.|||||
726498|NCT00364533|Secondary|Time to First Rescue Pain Medication.||3 days|Due to termination of trial, results were not analyzed.|||||
726499|NCT00364533|Primary|Sum of Pain Intensity Difference Over 48 Hours (SPID48)|The SPID score incorporates the cumulative analgesic effects of tapentadol IR on pain intensity over an extended period (48 hours) allowing for an evaluation of multiple doses of drug, even when dosing frequency may vary. Scoring is derived from the Numerical Rating Scale (NRS) from 0 = No pain to 11 = Pain as bad as you can imagine.|48 hours|Because the Sponsor terminated the study, the planned sample size was not reached in any treatment group, therefore, only a brief summary of an exploratory analysis of the primary efficacy variable (SPID48) is presented.||score on a scale||Standard Deviation|Mean
726500|NCT00364611|Secondary|Number of Participants With Adverse Events (AE)|"An adverse event (AE) was any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the clinical study. AEs occurring on or after first dose of study medication inclusive to 30 days post-last dose were the treatment emergent adverse events (TEAEs).
An serious adverse event was an AE that at any dose (including overdose) resulted in death, was life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability or incapacity, was a congenital anomaly, and/or was medically important."|From treatment initiation to 30 days after the last dose of study treatment|Safety population: all participants who received at least one dose of study medication||participants|||Number
726501|NCT00364611|Secondary|Overall Survival (OS) Time|"OS was the interval between the date of study entry and the date of death from any cause. In the absence of confirmation of death, survival time was censored at the last date the participant was known to be alive.
OS time was estimated from Kaplan-Meier Plots."|From treatment initiation to June 2011|Intent-to-treat population: all registered participants.||days|Participants|Inter-Quartile Range|Median
726502|NCT00364611|Secondary|Duration of Response (DR)|"DR was the interval from date of initial documented confirmed response (CR or PR) to the first documented confirmed date of disease progression (PD) or death from any cause in the absence of previous documentation of objective tumor progression.
Participants who were alive and without any record of PD at the time of discontinuation were censored at the last available tumor assessment date; participants with non-study anti-cancer therapy during the study were censored at the last available tumor assessment date prior to the anti-cancer therapy.
DR was estimated from Kaplan-Meier Plots."|From treatment initiation to June 2011|Participants with a documented response of CR or PR.||days|Participants|95% Confidence Interval|Median
726503|NCT00364611|Secondary|Number of Participants With Confirmed Clinical Benefit Based on RECIST Criteria|"Clinical Benefit (CB) was achieved in participants with a response (CR + PR) or a stable disease (SD).
According to RECIST
CR was the disappearance of all tumor lesions
PR was a pre-defined decrease in the size of tumor lesions
SD was neither sufficient decrease in tumor size to qualify for PR or sufficient increase to qualify for PD.
Confirmation of a response needed 2 responses scored, separated by 28 days or more (for CR and PR), and by 26 weeks or more (for SD)."|From treatment initiation to June 2011|Intent-to-treat: all registered participants.||participants|||Number
726504|NCT00364611|Secondary|Confirmed Overall Response (OR) Based on RECIST Criteria|"Confirmed OR was confirmed Complete Response (CR) + confirmed Partial Response (PR). According to RECIST
CR was the disappearance of all tumor lesions
PR was a pre-defined decrease in the size of tumor lesions.
To determine a response, radiologic tumors assessments were performed using computed tomography (CT) and/or magnetic resonance imaging (MRI) of the chest, and the abdomen, bone scan or positron emission tomography (PET) scan, and other imaging techniques as clinically indicated. To confirm a response, 2 assessments separated by 28 days or more were required."|From treatment initiation to June 2011|Intent-to-treat population: all registered participants.||participants|||Number
726505|NCT00364611|Primary|Time to Progression-free Survival (PFS)|"Time to PFS was the interval from the date of registration to the earliest of the following documented dates:
PD as defined by RECIST (criteria pre-defining changes in lesion size or appearance)
symptomatic deterioration
death.
Time to PFS was estimated from Kaplan-Meier Plots."|From treatment initiation to PFS event (up to June 2011)|Intent-to-treat population: all registered participants||days|Participants|95% Confidence Interval|Median
726506|NCT00364611|Primary|Progression-free Survival (PFS) Rate: Percentage of Participants With PFS|"PFS was the time from registration to first documentation of
progressive disease (PD) based on Response Evaluation Criteria in Solid Tumors (RECIST) - criteria pre-defining changes in lesion size or appearance
symptomatic deterioration
death due to any cause (in absence of PD).
The Percentage of participants with PFS is reported.
For the analysis, participants were censored
on the last available tumor assessment date on study treatment if they
had no PFS event
were on anticancer therapy not related to study treatment
on the registration date if they
did not receive study drug
had no post baseline tumor assessment"|Up to 6 months and 12 months after treatment initiation|Intent to treat population: all registered participants||percentage of participants||95% Confidence Interval|Number
726507|NCT00364793|Secondary|Percent of CD4 Cells Change From Baseline at Weeks 60, 72, 84, and 96 - Treated Participants|A CD4 cell is an antigenic marker of helper/inducer T cells. These cells were counted during the hematology cell counts performed during a Complete Blood Cell count (CBC) performed by the Central Laboratory. CD4 are measured as number of cells per millimeter to the third power (cells/mm^3). Percent of CD4 cells is the number of CD4 cells per total number of cells measured*100. An increase in the percent of CD4 cells is an improvement. The Baseline visit was within 50 days after the screening visit and was prior to start of study medication (Week 1).|Baseline to Weeks 60, 72, 84, and 96|Treated participants who received at least 1 dose of study drug (EFV) were analyzed. n=number of participants with available data at both baseline and each specific week on treatment.||percentage of CD4 cells||Inter-Quartile Range|Median
726551|NCT00364858|Secondary|Mean Composite Scores of the SF-36 Health Survey at Month 24/Discontinuation.|The mean composite scores (0 being worst and 100 being best) for both treatment groups at Month 24/Discontinuation. The mean composite scores for both treatment groups approximated those of the general population at baseline and at Month 24.|Month 24 (or at time of discontinuation)|Quality of life was evaluated and measured by the SF-36 questionnaire.||Units on a scale||Standard Deviation|Mean
726508|NCT00364793|Secondary|CD4 Cell Count Change From Baseline at Weeks 60, 72, 84, and 96 - Treated Participants|A CD4 cell is an antigenic marker of helper/inducer T cells. These cells were counted during the hematology cell counts performed during a Complete Blood Cell count (CBC) performed by the Central Laboratory. CD4 are measured as number of cells per millimeters to the third power (cells/mm^3). An increase from baseline in the number of CD4 cells is an improvement. The Baseline visit was within 50 days after the screening visit and was prior to start of study medication (Week 1).|Baseline to Weeks 60, 72, 84, and 96|Treated participants who received at least 1 dose of study drug (EFV) were analyzed. n=number of participants with available data at both baseline and each specific week on treatment.||cells/mm^3||Inter-Quartile Range|Median
726509|NCT00364793|Secondary|Log10 c/mL HIV RNA Changes From Baseline at Weeks 60, 72, 84 and 96 - Treated Participants|HIV RNA measured as log10 copies per milliliter (c/mL) plasma. HIV RNA values ≥ 1,000 c/mL were considered evidence of infection. A decrease in number of c/mL is an improvement for the participant. HIV RNA was first measured using the ultrasensitive and standard Roche Amplicor PCR, version 1.5, and then the method of measurement was switched to the COBAS AmpliPrep/COBAS TaqMan HIV IVD method. The Baseline visit was within 50 days after the screening visit and was prior to start of study medication (Week 1).|Baseline through Weeks 60, 72, 84, and 96|Treated participants who received at least 1 dose of study drug (EFV) were analyzed. n=number of participants with available data at both baseline and each specific week on treatment.||log10 c/mL||Inter-Quartile Range|Median
726510|NCT00364793|Secondary|The Number of Participants With Plasma HIV RNA Levels < 50 c/mL at Weeks 60, 72, 84 and 96 (Observed Cases) – All Treated Participants|Virologic Response - Observed Cases (VR-OC): participants were responders at a specific week according to a single on-treatment HIV RNA < 50 c/mL closest to the planned visit and within the predefined visit window; those on treatment and missing their specific week measurement were responders only if previous and subsequent measurements to that week visit window were < 50 c/mL; denominator was all who remained on treatment through the specific week.|Weeks 60, 72, 84, and 96|Treated participants, who received at least 1 dose of study drug (EFV) were analyzed. n=number of treated participants with available on-treatment data at each specific week.||participants|||Number
726511|NCT00364793|Secondary|The Number of Participants With Plasma HIV RNA Levels < 400 c/mL at Weeks 60, 72, 84 and 96 (Observed Cases) – All Treated Participants|Virologic Response - Observed Cases (VR-OC): participants were responders at a specific week according to a single on-treatment HIV RNA < 400 c/mL closest to the planned visit and within the predefined visit window; those on treatment and missing their specific week measurement were responders only if previous and subsequent measurements to that week visit window were < 400 c/mL; denominator was all who remained on treatment through the specific week.|Weeks 60, 72, 84, and 96|Treated participants, who received at least 1 dose of study drug (EFV) were analyzed. n=number of treated participants with available on-treatment data at each specific week.||participants|||Number
726512|NCT00364793|Secondary|Terminal Phase Elimination Half-life (T-HALF) in Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population|Plasma concentrations for ddI were determined using a validated LC/MS/MS assay. The LLOQ for ddI was 2.50 nanograms per milliliter (ng/mL). Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the T-HALF was summarized using a mean. Terminal elimination plasma half-life=ln2 divided by K where K is the absolute value of the slope of the terminal phase of the plasma profile as determined by log-linear regression of at least three data points. T-HALF was measured in hours (h).|Week 2|All participants who received at least one dose of study drug (EFV) and had adequate pharmacokinetic (PK) profiles were analyzed.||h||Standard Deviation|Mean
726513|NCT00364793|Secondary|CLT/F/kg of Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population|Plasma concentrations for ddI were determined using a validated LC/MS/MS assay. The LLOQ for ddI was 2.50 nanograms per milliliter (ng/mL). CLT/F/kg was calculated by dividing CLT/F by body weight in kilograms (kg). Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters were summarized using geometric means. CLT/F/kg was measured in liters per hour per kilogram (L/h/kg).|Week 2|All participants who received at least one dose of study drug (EFV) and had adequate pharmacokinetic (PK) profiles were analyzed.||L/h/kg||Geometric Coefficient of Variation|Geometric Mean
726514|NCT00364793|Secondary|CLT/F of Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population|Plasma concentrations for ddI were determined using a validated LC/MS/MS assay. The LLOQ for ddI was 2.50 nanograms per milliliter (ng/mL). CLT/F was calculated by dividing the dose of ddI by AUC(TAU) of ddI. Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters were summarized using geometric means. CLT/F was measured in liters per hour (L/h).|Week 2|All participants who received at least one dose of study drug (EFV) and had adequate pharmacokinetic (PK) profiles were analyzed.||L/h||Geometric Coefficient of Variation|Geometric Mean
726515|NCT00364793|Secondary|AUC (TAU) of Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population|Plasma concentrations were obtained using a validated LC-MS/MS at Week 2. The lower limit of quantification (LLOQ) for ddI was 2.50 nanograms per milliliter (ng/mL). AUC(TAU) was calculated by log- and linear trapezoidal summations. If a concentration was < LLOQ at time TAU, the value of the concentration at time TAU was estimated using the quotient of the last quantifiable concentration and λ. Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters summarized using geometric means. AUC(TAU) was measured in nanograms*time per milliliter (ng•h/mL).|Week 2|All participants who received at least one dose of study drug (EFV) and had adequate pharmacokinetic (PK) profiles were analyzed.||ng•h/mL||Geometric Coefficient of Variation|Geometric Mean
726552|NCT00364858|Secondary|Mean Composite Scores of the SF-36 Health Survey at Baseline|The mean composite scores (0 being worst and 100 being best) for both treatment groups at Baseline. Composite scores for both treatment groups approximated those of the general population at baseline and at Month 24.|Baseline|Quality of life was evaluated and measured by the SF-36 questionnaire.||Units on a scale||Standard Deviation|Mean
727228|NCT00362180|Secondary|Percent Change in Low-Density Lipoprotein Cholesterol From Baseline to Day 99|Samples were taken following an overnight fast.|Day 26 and Day 99|Full analysis set with last observation carried forward.||percent change||Inter-Quartile Range|Median
726516|NCT00364793|Secondary|Cmax and Cmin of Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population|Cmax and Cmin were derived from plasma concentration versus time. Plasma concentrations for ddI were determined using a validated LC/MS/MS assay. All reportable Cmin values were <LLOQ in all age groups except >=6 months to < 2 years (Group 2); LLOQ/2 was imputed for those summary statistics;in Group 2, 9 of 10 Cmin values were <LLOQ; LLOQ/2 was imputed for those samples for summary statistics. The lower limit of quantification (LLOQ) for ddI was 2.50 nanograms per milliliter (ng/mL). Cmax and Cmin were recorded directly from experimental observations. Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters were summarized using geometric means. Cmax and Cmin were measured in ng/mL.|Week 2|All participants who received at least one dose of study drug (EFV) and had adequate pharmacokinetic (PK) profiles were analyzed.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
726517|NCT00364793|Secondary|Number of Participants With Acquisition of Resistance to EFV Categorized by AUC Relationship - Evaluable Pharmacokinetic Population|PK parameters were evaluated 2 weeks post start of dosing. Based on observed AUC, measured in micromoles (μM)*h, dosing was increased, remained the same, or decreased at next visit to achieve the desired AUC (110-380 μM*h). Number of participants who became resistant was categorized by those who required additional dosing after Week 2 (AUC<110 μM*h) and those who did not. AUC: derived from plasma concentration of EFV versus time. Plasma concentrations for determination of AUC were obtained using a validated LC-MS/MS method. LLOQ for EFV = 10.0 ng/mL and ULOQ = 8,000 ng/mL. AUC calculated by log- and linear trapezoidal summations. Genotypic resistance=presence of substitutions in the RT gene and/or presence of mutations that confer resistance to entire nucleoside reverse transcriptase inhibitor class. Phenotypic resistance=EFV: > 3.3* IC50 of control strain. Assays: Monogram Biosciences Phenosense™ GT (EFV biologic cutoff=3) and VircoTYPE™ HIV-1 v 4.3.01( EFV biologic cutoff=3.3).|Baseline to Week 48|All participants who received at least one dose of study drug (EFV) and had adequate pharmacokinetic (PK) profiles at Week 2 were analyzed. n=number of participants with AUC<110 µM•h and number of participants with AUC>=110 µM•h.||participants|||Number
726518|NCT00364793|Secondary|Number of Treated Participants With Resistance Associated Genotypic and Phenotypic Changes in Viruses - Participants With Virologic Failure, Lack of Suppression or Viral Load Rebound|At baseline, treatment-naïve screened by genotype; treatment-experienced screened by genotype and phenotype. Genotypic resistance: presence of substitutions in reverse transcriptase (RT) gene and/or presence of mutations that confer resistance to nucleoside reverse transcriptase inhibitor class. Phenotype resistance: FTC: > 3.1* the 50% inhibitory concentration (IC50) of the control strain; EFV: > 3.3* IC50 ; ddI: > 2.6*IC50. Virologic failure: <1 log10 decrease in HIV RNA from Week 16 on; confirmatory HIV RNA within 14-35 days; HIV RNA > 10,000 c/mL with prior value < 400 c/mL; confirmatory HIV RNA 14-35 days. Monogram Biosciences Phenosense™ assay ( EFV and FTC: biologic cutoffs=3 and 3.5, respectively; ddI: clinical cutoff: lower limit=1.39; upper limit = 2.2.); VircoTYPE™ HIV-1 v 4.3.01( EFV, FTC: biologic cutoffs=3.3 and 3.1, respectively;ddI: clinical cutoff: lower limit = 0.9; upper limit = 2.6. No genotypic/phenotypic changes in presence of virologic failure=no resistance.|Baseline to Week 48|Participants who met the definition of virologic failure per protocol (PP): n=6 ; in addition, those who rebounded on treatment with plasma HIV RNA > 10,000 c/mL but samples were not obtained within specified 35 day limit were included (not PP): n=5; participants with virologic failure and with samples available for analysis of virus changes:n=11.||participants|||Number
726519|NCT00364793|Secondary|Number of Participants With Hematologic Abnormalities - Treated Participants|Abnormalities were determined from laboratory measurements analyzed at the central or local laboratory. DAIDS DAIDS Grading Severity of Adult and Pediatric AEs v Dec 2004. Hemoglobin Gr 1: 8.5-10.0 g/dL; Gr 2: 7.5-8.4 g/dL; Gr 3: 6.50-7.4 g/dL; Gr 4: <6.5 g/dL; Platelets, decreased: Gr 1: 100.000-124.999*10^9/L; Gr 2: 50.000-99.999*10^9/L; Gr 3: 25.000-49.999*10^9/L; Gr 4: <25.000*10^9/L; White blood cell count (WBC) decreased Gr 1: 2.000-2.500*10^9/L; Gr 2: 1.500-1.999*10^9/L; Gr 3: 1.000-1.499*10^9/L; Gr 4: <1.000*10^9/L. Baseline visit was within 50 days post screening and was prior to start of study drug (Week 1).|Baseline to Week 96|Treated participants, who received at least 1 dose of study drug (EFV) were analyzed. n=number of treated participants with available on-treatment data (laboratory measurements).||participants|||Number
726520|NCT00364793|Secondary|Number of Participants With Serum Chemistry Abnormalities - Treated Participants|Central/local laboratory. DAIDS v 2004. Bicarbonate, low: Gr 1: 16 milliequivalents per liter (mEq/L) - < LLN; Gr 2: 11.0-15.9 mEq/L; Gr 3: 8.0-10.9 mEq/L; Gr 4: <8.0 mEq/L; calcium, high Gr 1: 10.6-11.5 mg/dL; Gr 2: 11.6-12.5 mg/dL; Gr 3 12.6-13.5 mg/dL; Gr 4: >13.5 mg/dL; calcium, low Gr1: 7.8-8.4 mg/dL; Gr2: 7.0-7.7 mg/dL; Gr3: 6.1-6.9 mg/dL; Gr 4: <6.1 mg/dL; creatinine Gr1: 1.1-1.3*ULN; Gr 2: 1.4-1.8*ULN; Gr 3: 1.9-3.4*ULN; Gr 4: >=3.5*ULN; lipase Gr 1: 1.1-1.5*ULN; Gr 2: 1.6-3.0*ULN; Gr 3: 3.1-5.0*ULN; Gr 4: >5.0*ULN; potassium high (low) Gr 1: 5.6-6.0 (3.0-3.4) mEq/L; Gr 2: 6.1-6.5 (2.5-2.9) mEq/L; Gr 3: 6.6-7.0 (2.0-2.4) mEq/L; Gr 4: >7.0 (<2.0) mEq/L; sodium, high (low) Gr 1: 146-150 (130-135) mEq/L; Gr 2: 151-154 (125-129) mEq/L; Gr 3: 155-159 (121-124) mEq/L; Gr 4: >=160 (<=120) mEq/L; uric acid Gr 1: 7.5-10.0 mg/dL; Gr 2: 10.1-12.0 mg/dL; Gr 3: 12.1-15.0 mg/dL; Gr 4: >15.0 mg/dL. Baseline within 50 days post screening, prior to start of study medication.|Baseline to Week 96|Treated participants, who received at least 1 dose of study drug (EFV) were analyzed. n=number of treated participants with available on-treatment data (laboratory measurements).||participants|||Number
726521|NCT00364793|Secondary|Number of Participants With Lipid and Glucose Laboratory Abnormalities - Treated Participants|Abnormalities were determined from measurements analyzed at central or local laboratory. DAIDS Grading Severity of Adult and Pediatric AEs v Dec 2004. Total Cholesterol (fasting) Gr 1: 170 - 199 mg/dL; Gr 2: 200 - 300 mg/dL; Gr 3 >300 mg/dL; Gr 4 Not Applicable(NA). LDL cholesterol, fasting: Gr 1: 110-129 mg/dL; Gr 2: 130-189 mg/dL; Gr 3 >=190 mg/dL; Gr 4 NA. Triglycerides, fasting: Gr 1: NA; Gr 2 500-750 mg/dL; Gr 3: 751-1,200 mg/dL; Gr 4: >1,200 mg/dL. Glucose, serum, high, fasting and (non-fasting): Gr 1: 110 - 125 (116-160) mg/dL; Gr 2: 126-250 (161- 250) mg/dL; Gr 3: 251-500 (251-500) mg/dL; Gr 4: >500 (> 500) mg/dL. Glucose, serum, low, >=1 month of age (<1 month): Gr 1: 55-64 (50-54) mg/dL; Gr 2: 40-54 (40-49) mg/dL; Gr 3: 30-39 (30-39) mg/dL; Gr 4: <30 (<30) mg/dL. Baseline: within 50 days after the screening visit and was prior to start of study medication (Week 1). Only those in 4th arm were old enough to fast prior to testing; other arms did not have fasting samples taken.|Baseline to Week 96|Treated participants, who received at least 1 dose of study drug (EFV) were analyzed. n=number of treated participants with available on-treatment data (laboratory measurements).||participants|||Number
726522|NCT00364793|Secondary|Number of Participants With Liver Function Test Laboratory Abnormalities - Treated Population|Abnormalities were determined from laboratory measurements analyzed at the central or local laboratory. Division of AIDS Table (DAIDS) for Grading Severity of Adult and Pediatric AEs version (v) Dec 2004. Upper limit of normal (ULN): lower limit of normal (LLN), alanine transaminase (ALT); aspartate aminotransferase (AST); alkaline phosphatase (ALP). ALT Grade (Gr) 1: 1.25 to 2.5*ULN; Gr 2: 2.6 to 5.0*ULN; Gr 3: 5.1 to 10.0*ULN; Gr 4: >10.0*ULN. AST Gr 1: 1.25 to 2.5*ULN; Gr 2: 2.6 to 5.0*ULN; Gr 3: 5.1 to 10.0*ULN; Gr 4: >10.0*ULN. Total bilirubin Gr 1: 1.25 to 1.5*ULN; Gr 2: 1.6 to 2.5*ULN; Gr 3: 2.6 to 5.0*ULN; Gr 4: >5.0*ULN. ALP (U/L) Gr 1: 1.25 to 2.5*ULN, Gr 2: 2.6 to 5.0*ULN, Gr 3: 5.1 to 10.0*ULN, Gr 4: >10.0*ULN. Albumin (low) Gr 1: 3 grams per deciliter (g/dL) to <LLN ; Gr 2: 2.0-2.9 g/dL; Gr 3: < 2 g/dL. Gr 4: Not applicable. Baseline visit was within 50 days after the screening visit and was prior to start of study medication (Week 1).|Baseline to Week 96|Treated participants, who received at least 1 dose of study drug (EFV) were analyzed. n=number of treated participants with available on-treatment data (laboratory measurements).||participants|||Number
726523|NCT00364793|Secondary|Number of Participants With On-Treatment Adverse Events (AEs), Related Adverse Events, Serious Adverse Events (SAEs), Death, Discontinuation Due to Adverse Events, and CDC Class C AIDS Events|Center for Disease Control and Prevention (CDC) classification of Class C events used to define acquired immunodeficiency syndrome (AIDS): include pneumocystis pneumonia, pneumonia, pulmonary tuberculosis. AE=new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. AE Severity: Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling (Division of AIDs Table, published December 2004). Baseline=within 50 days post screening, prior to start of study drug. 2 categories for death presented (on-treatment and enrolled/not treated).|Baseline to Week 96|All categories except one analyzed treated participants, who received at least 1 dose of study drug (EFV). One category analyzed enrolled participants who were not treated and cannot be assigned to a group.||participants|||Number
726524|NCT00364793|Primary|Apparent Oral Clearance Adjusted for Body Weight (CLT/F/kg) of EFV at Week 2 - Pharmacokinetic Evaluable Population|Plasma concentrations of EFV were determined using a validated liquid chromatography tandem mass spectrometry method (LC-MS/MS). The lower limit of quantification (LLOQ) for EFV was 10.0 nanograms per milliliter (ng/mL) and the upper limit of quantification (ULOQ) was 8,000 ng/mL. CLT/F/kg was calculated by dividing CLT/F by body weight in kilograms (kg). Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters were summarized using geometric means. CLT/F/kg was measured in liters per hour per kilogram (L/h/kg).|Week 2|All participants who received at least one dose of study drug (EFV) and had adequate pharmacokinetic (PK) profiles were analyzed.||L/h/kg||Geometric Coefficient of Variation|Geometric Mean
726525|NCT00364793|Primary|Apparent Oral Clearance (CLT/F) of EFV at Week 2 - Pharmacokinetic Evaluable Population|Plasma concentrations of EFV were obtained using a validated liquid chromatography tandem mass spectrometry method (LC-MS/MS). The lower limit of quantification (LLOQ) for EFV was 10.0 nanograms per milliliter (ng/mL) and the upper limit of quantification (ULOQ) was 8,000 ng/mL. CLT/F was calculated by dividing the dose of EFV by AUC(TAU) of EFV. Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters were summarized using geometric means. CLT/F was measured in liters per hour (L/h).|Week 2|All participants who received at least one dose of study drug (EFV) and had adequate pharmacokinetic (PK) profiles were analyzed.||L/h||Geometric Coefficient of Variation|Geometric Mean
726526|NCT00364793|Primary|Area Under the Plasma Concentration Time Curve (AUC) Over One Dosing Interval From Time Zero to 24 Hours Post-dose(TAU) at Week 2 - Pharmacokinetic Evaluable Population|Plasma concentrations were obtained using a validated liquid chromatography tandem mass spectrometry method (LC-MS/MS). The lower limit of quantification (LLOQ) for EFV was 10.0 nanograms per milliliter (ng/mL) and the upper limit of quantification (ULOQ) was 8,000 ng/mL. AUC(TAU) was calculated by log- and linear trapezoidal summations. If a concentration was < LLOQ at time TAU, the value of the concentration at time TAU was estimated using the quotient of the last quantifiable concentration and λ. Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters summarized using geometric means. AUC(TAU) was measured in micromolars*time (µM•h).|Week 2|All participants who received at least one dose of study drug (EFV) and had adequate pharmacokinetic (PK) profiles were analyzed.||µM•h||Geometric Coefficient of Variation|Geometric Mean
726527|NCT00364793|Secondary|Percent of CD4 Cells Change From Baseline at Weeks 24 and 48 - Treated Participants|A CD4 cell is an antigenic marker of helper/inducer T cells. These cells were counted during the hematology cell counts performed during a Complete Blood Cell count (CBC) performed by the Central Laboratory. CD4 are measured as number of cells per millimeter to the third power (cells/mm^3). Percent of CD4 cells is the number of CD4 cells per total number of cells measured*100. An increase in the percent of CD4 cells is an improvement. The Baseline visit was within 50 days after the screening visit and was prior to start of study medication (Week 1).|Baseline to Weeks 24 and 48|Treated participants who received at least 1 dose of study drug (EFV) and had an available baseline measurement were analyzed. n=number of participants with available data at both baseline and each specific week.||percentage of CD4 cells||Inter-Quartile Range|Median
726528|NCT00364793|Secondary|CD4 Cell Count Change From Baseline at Weeks 24 and 48 - Treated Participants|A CD4 cell is an antigenic marker of helper/inducer T cells. These cells were counted during the hematology cell counts performed during a Complete Blood Cell count (CBC) performed by the Central Laboratory. CD4 are measured as number of cells per millimeters to the third power (cells/mm^3). An increase from baseline in the number of CD4 cells is an improvement. The Baseline visit was within 50 days after the screening visit and was prior to start of study medication (Week 1).|Baseline to Weeks 24 and 48|Treated participants who received at least 1 dose of study drug (EFV) and had an available baseline measurement were analyzed. n=number of participants with available data at both baseline and each specific week.||cells/mm^3||Inter-Quartile Range|Median
726529|NCT00364793|Secondary|Log10 c/mL HIV RNA Changes From Baseline Through Week 48 - Treated Participants|HIV RNA measured as log10 copies per milliliter (c/mL) plasma. HIV RNA values ≥ 1,000 c/mL were considered evidence of infection. A decrease in number of c/mL is an improvement for the participant. HIV RNA was first measured using the ultrasensitive and standard Roche Amplicor PCR, version 1.5, and then the method of measurement was switched to the COBAS AmpliPrep/COBAS TaqMan HIV IVD method. The Baseline visit was within 50 days after the screening visit and was prior to start of study medication (Week 1).|Baseline through Week 48|Treated participants who received at least 1 dose of study drug (EFV) and had an available baseline measurement were analyzed. n=number of participants with available data at both baseline and each specific week.||log10 c/mL||Inter-Quartile Range|Median
726530|NCT00364793|Secondary|The Number of Participants With Plasma HIV RNA Levels < 50 c/mL at Week 24 as Analyzed by Different Algorithms - All Treated Participants|Algorithms: Confirmed Virologic Response (CVR) non-completer = failure (NC = F): participants were responders if they achieved confirmed HIV RNA < 50 c/mL at Week 24; participants were failures if virologic rebound occurred at or before Week 24; therapy discontinued before Week 24; no response by Week 24, or missing HIV RNA at Week 24 and beyond. Virologic Response - Observed Cases (VR-OC): participants were responders according to a single on-treatment HIV RNA < 50 c/mL closest to the planned Week 24 visit and within the predefined Week 24 visit window; those on treatment and missing their Week 24 measurement were responders only if previous and subsequent measurements to the Week 24 visit window were < 50 c/mL; denominator was all who remained on treatment through Week 24.|Week 24|Treated participants, who received at least 1 dose of study drug (EFV), were analyzed. n=number of participants with available on-treatment data for analysis by each algorithm.||participants|||Number
726531|NCT00364793|Secondary|The Number of Participants With Plasma HIV RNA Levels < 400 c/mL at Week 24 as Analyzed by Different Algorithms - All Treated Participants|Algorithms: Confirmed Virologic Response (CVR) non-completer = failure (NC = F): participants were responders if they achieved confirmed HIV RNA < 400 c/mL at Week 24; participants were failures if virologic rebound occurred at or before Week 24; therapy discontinued before Week 24; no response by Week 24, or missing HIV RNA at Week 24 and beyond. Virologic Response - Observed Cases (VR-OC): participants were responders according to a single on-treatment HIV RNA < 400 c/mL closest to the planned Week 24 visit and within the predefined Week 24 visit window; those on treatment and missing their Week 24 measurement were responders only if previous and subsequent measurements to the Week 24 visit window were < 400 c/mL; denominator was all who remained on treatment through Week 24.|Week 24|Treated participants, who received at least 1 dose of study drug (EFV), were analyzed. n=number of participants with available on-treatment data for analysis by each algorithm.||participants|||Number
726532|NCT00364793|Secondary|The Number of Participants With Plasma HIV RNA Levels < 50 c/mL at Week 48 as Analyzed by Different Algorithms - All Treated Participants|Algorithms: Confirmed Virologic Response (CVR) non-completer = failure (NC = F): participants were responders if they achieved confirmed HIV RNA < 50 c/mL at Week 48; participants were failures if virologic rebound occurred at or before Week 48; therapy discontinued before Week 48; no response by Week 48, or missing HIV RNA at Week 48 and beyond. Virologic Response - Observed Cases (VR-OC): participants were responders according to a single on-treatment HIV RNA < 50 c/mL closest to the planned Week 48 visit and within the predefined Week 48 visit window; those on treatment and missing their Week 48 measurement were responders only if previous and subsequent measurements to the Week 48 visit window were < 50 c/mL; denominator was all who remained on treatment through Week 48. Snapshot: participants were responders according to the last on-treatment HIV RNA < 50 c/mL in the predefined Week 48 visit window; denominator was all treated participants.|Week 48|Treated participants, who received at least 1 dose of study drug (EFV), were analyzed. n=number of participants with available on-treatment data for analysis by each algorithm.||participants|||Number
726533|NCT00364793|Secondary|The Number of Participants With Plasma HIV RNA < 400 Copies Per Milliliter (c/mL) at Week 48 as Analyzed by Different Algorithms - All Treated Participants|Algorithms: Confirmed Virologic Response (CVR) non-completer = failure (NC = F): participants were responders if they achieved confirmed HIV RNA < 400 c/mL at Week 48; participants were failures if virologic rebound occurred at or before Week 48; therapy discontinued before Week 48; no response by Week 48, or missing HIV RNA at Week 48 and beyond. Virologic Response - Observed Cases (VR-OC): participants were responders according to a single on-treatment HIV RNA < 400 c/mL closest to the planned Week 48 visit and within the predefined Week 48 visit window; those on treatment and missing their Week 48 measurement were responders only if previous and subsequent measurements to the Week 48 visit window were < 400 c/mL; denominator was all who remained on treatment through Week 48. Snapshot: participants were responders according to the last on-treatment HIV RNA < 400 c/mL in the predefined Week 48 visit window; denominator was all treated participants.|Week 48|Treated participants, who received at least 1 dose of study drug (EFV), were analyzed. n=number of participants with available on-treatment data for analysis by each algorithm.||participants|||Number
726534|NCT00364793|Primary|Maximum Observed Plasma Concentration (Cmax) and Plasma Concentration 24 Hours Post-dose (Cmin) of EFV at Week 2 - Pharmacokinetic Evaluable Population|Cmax and Cmin were derived from plasma concentrations versus time using a validated liquid chromatography tandem mass spectrometry method (LC-MS/MS). The lower limit of quantification (LLOQ) for EFV was 10.0 nanograms per milliliter (ng/mL) and the upper limit of quantification (ULOQ) was 8,000 ng/mL. Cmax and Cmin were recorded directly from experimental observations. Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters were summarized using geometric means. Cmax and Cmin were measured in ng/mL.|Week 2|All participants who received at least one dose of study drug (EFV) and had adequate pharmacokinetic (PK) profiles were analyzed.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
726535|NCT00364819|Secondary|Change in Serum Alkaline Phosphatase|The difference in serum alkaline phosphatase from Baseline to Week 52|52 Weeks|||U/L||Standard Deviation|Mean
726536|NCT00364819|Secondary|Change in Serum Immunoglobulin M|The difference in serum immunoglobulin M from Baseline to Week 52|52 Weeks|||mg/dL||Standard Deviation|Mean
726537|NCT00364819|Secondary|Change in Serum Immunoglobulin A|The difference in serum immunoglobulin A from Baseline to Week 52|52 Weeks|1 subject with missing data.||mg/dL||Standard Deviation|Mean
726538|NCT00364819|Secondary|Change in Serum Immunoglobulin G|The difference in serum immunoglobulin G from Baseline to Week 52|52 Weeks|||mg/dL||Standard Deviation|Mean
726540|NCT00364832|Secondary|Number of Participants With Any Adverse Events, Any Serious Adverse Events, And Deaths|An Adverse Events (AEs) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Serious Adverse Events (SAEs) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator’s judgment or requires intervention to prevent one or other of these outcomes. The study design tested 3 different starting dose conversion factors at 3 different dosing schedules during the core study period. As study drug doses can be modified continually over time all results for the two long term safety periods were displayed by dose schedule group only.|Up to Week 126|The safety population was considered for analysis which included all participants who received at least one dose of study drug.||Participants|||Number
726541|NCT00364832|Secondary|Number of Participants With Marked Laboratory Abnormalities|Participants with marked laboratory abnormalities were reported. Marked abnormality criteria: Serum glutamic oxaloacetic transaminase (SGOT); high >25 units per litre (U/L), albumin (low < 31 grams per litre [g/L]), total protein (< 60 g/L), phosphate (high >1.45 millimoles per litre [mmol/L]); Low <0.84 mmol/L), potassium (high >5 mmol/L; Low <3.5 mmol/L), platelets (low:<150×10^9/L), White blood cells ([WBCs]); high: 10.8×10^9/L and Low:4.3×10^9/L), basophils (high:>0.15×10^9/L), eosinophils (high:>0.70×10^9/L), lymphocytes (low:<1.50×10^9/L), and neutrophils (low:<1.83×10^9/L).|Up to Week 126|The safety population was considered for analysis which included all participants who received at least one dose of study drug.||Participants|||Number
726542|NCT00364832|Secondary|Mean Change in Pulse Rate|Mean change in pulse rate was reported.|Up to Week 126|The safety population was considered for analysis which included all participants who received at least one dose of study drug. Participants with available data at the time of evaluation were analyzed.||Beats per minute||Standard Deviation|Mean
726543|NCT00364832|Secondary|Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Before and After Dialysis|Mean Change from Baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) is calculated as the end of treatment values minus the Baseline value. Baseline (Day -28 to Day 1) value is the measurements taken at screening assessment and run-in period (Weeks –2 and –1).|From Baseline (Day -28 to Day 1) to Week 126|The safety population was considered for analysis which included all participants who received at least one dose of study drug.||Millimeters of Mercury||Standard Deviation|Mean
726544|NCT00364832|Secondary|Median Change From Baseline in Hematocrit Levels to End of Initial Treatment Under Constant Dosing Regimen|Median change from Baseline in hematocrit (Hct) levels to end of initial treatment under constant dosing regimen was reported. Baseline (Day -28 to Day 1) Hct values was calculated as the mean of the SA and run-in period (Weeks -2 and -1). For all participants, an EOIT value was calculated as the last observed Hct value before a dose change or blood transfusion. For participants without any dose adjustments or blood transfusion, the EOIT value was identical to the Week 19 (or Week 21) value.|From Baseline (Day -28 to Day 1) to EOIT (Week 19 or Week 21)|The ITT population was considered for analysis which included all randomized participants.||Percentage of Hct||Inter-Quartile Range|Median
726545|NCT00364832|Primary|Median Change From Baseline in Hemoglobin Levels to End of Initial Treatment Under Constant Dosing Regimen|Median change from Baseline in hemoglobin (Hb) levels to end of initial treatment (EOIT) under constant dosing regimen was reported. For ease of interpretation, all individual slope values were multiplied by 42 to give an estimate of change in Hb values over six weeks. Baseline (Day -28 to Day 1) Hb values was calculated as the mean of the screening assessment (SA) and run-in period (Week -2 and –1). For all participants, an EOIT value was calculated as the last observed Hb value before a dose change or blood transfusion. For participants without any dose adjustments or blood transfusion, the EOIT value was identical to the Week 19 (or Week 21) value.|From Baseline (Day -28 to Day 1) to EOIT (Week 19 or Week 21)|The ITT population was considered for analysis which included all randomized participants.||gram per deciliter||Inter-Quartile Range|Median
726546|NCT00364845|Secondary|Euroqol 5 Dimension (EQ-5D) Utility Score at Week 24|The EQ-5D is a patient-completed, multidimensional measure of health related quality of life. The instrument is applicable to a wide range of health conditions and treatments and results in a single index score. The EQ-5D descriptive health profile comprises five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension comprises three levels (no problems, some/moderate problems, extreme problems). A unique EQ-5D health state is defined by combining one level from each of the five dimensions. EQ-5D index values range from -0.59 to 1.00. Higher EQ-5D Index scores represent better health status.|Week 24|Subset of Full Analysis Set, composed of all randomized participants with available data||Units on a scale||95% Confidence Interval|Mean
726547|NCT00364845|Secondary|Mean Hemoglobin During the Evaluation Period||Evaluation Period (Weeks 22-36)|Subset of Full Analysis Set, composed of all randomized participants with available data||g/L||95% Confidence Interval|Mean
726548|NCT00364845|Secondary|Number of Participants With Hemoglobin (Hb) ≥ 110 g/L|Number of participants achieving a Hemoglobin (Hb) value ≥ 110 g/L during the evaluation period.|Evaluation Period (Weeks 22-36)|Subset of Full Analysis Set, composed of all randomized participants with available data||Participants|||Number
726549|NCT00364845|Primary|Short Form 36 Health Survey Questionnaire (SF-36) Vitality Subscale Score at Week 24|The SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The vitality sub-score assesses energy and fatigue, and ranges from 0 (worst) - 100 (best).|Week 24|Subset of Full Analysis Set, composed of all randomized participants with available data.||Units on a scale||Standard Error|Mean
726550|NCT00364858|Secondary|Mean Change From Baseline in Composite Scores of the SF-36 Health Survey at Month 24/Discontinuation|The mean composite scores (0 being worst and 100 being best) for both treatment groups approximated those of the general population at baseline. Composite score - The overall composite scores were comprised of a standardized physical and mental component score.|Baseline and Month 24 (or at time of discontinuation)|Quality of life was evaluated and measured by the SF-36 questionnaire.||Units on a scale||Standard Deviation|Mean
726569|NCT00365053|Secondary|Overall Survival|Estimated using the product-limit method of Kaplan and Meier.|Up to 3 years|||Months||95% Confidence Interval|Median
726553|NCT00364858|Primary|Number of Participants With Clinical Success at Month 24/Discontinuation|Patients are considered to be a clinical success if ALL of the following are met: The patient’s hemoglobin does not fall more than 1.25g/dL for women or 1.5 g/dL for men below the patient’s baseline value, platelet count does not fall more than 25% below the patient’s baseline value or does not fall below 80,000 mm3, liver and spleen volumes are not greater than 20% above the patient’s baseline value, no evidence of bone disease progression, including no incidence of pathologic fractures, medullary infarctions, lytic lesions or avascular necrosis and has had no bone crises during the study.|Month 24 (or at time of discontinuation)|Intent-to-Treat (ITT) Population. All patients who enrolled in the study and received AT LEAST ONE infusion were included in the ITT population.||patients|||Number
726554|NCT00364923|Secondary|Overall Survival Per Independent Central Review|Calculated as date of death - date of enrollment +1, estimated using the product-limit estimator. Pts who had not died (no record of death) or were lost to follow-up were censored at the date of last contact. Pts who withdrew consent to participate in the study including consent to be followed, were censored on the date of withdrawal. Pts who withdrew from treatment without withdrawing consent were followed for survival status whenever possible.|Assessed every 14 weeks while on treatment, and after disease progression no less frequently than every 6 months for up to 2 years after first dose.|Analysis was per protocol, based on the number of patients (pts) who had an event (death or censoring) at the time of data cut-off.||Months||Full Range|Median
726555|NCT00364923|Secondary|Progression-free Survival Per Independent Central Review|Patients (pts) with subsequent therapy prior to PD were censored at date of last response assessment prior to subsequent therapy. Pts who were alive without PD were censored at the date of last assessment of first dose. Pts who withdrew consent to participate in the study prior to PD were censored at the date of their last disease assessment or treatment day 1. Pts who withdrew consent from treatment prior to PD without withdrawing consent for follow-up were followed for disease status & survival. Pts who did not have response assessments after baseline were censored at treatment day 1.|Calculated as the number of days from treatment day 1 to the date of disease progression or death, regardless of cause for up to 2 years after initial dose|Analysis was per protocol, based on the number of patients (pts) who had an event of progressive disease (PD) or death. Pts who did not have an event at the time of data cut-off were censored. Pts were censored for lack of PD, receipt of other anti-cancer therapy before PD, termination of study/follow-up for response, and transplant.||Days||Full Range|Median
726556|NCT00364923|Secondary|Duration of Response Per Independent Central Review|Calculated only for those pts with an objective response. Pts receiving subsequent therapy (including transplant) before progressive disease (PD) was documented were censored at date of last response assessment obtained prior to subsequent therapy, with a note indicating censoring occurrence & reason. Pts who withdrew consent to participate in the study prior to PD were censored at the date of their last evaluable assessment of response. Pts who withdrew from treatment prior to PD or initiation of subsequent therapy without withdrawing consent were followed for disease status when possible.|Measured from the first day of documented response, assessed at prior to every other even-numbered cycle (every 14 weeks) until disease progression or death for up to 2 years after initial dose|Analysis was per protocol. Based on the number of responding pts (n=32) in the evaluable population (n=109), as assessed by independent central review protocol.||Days||Full Range|Median
726557|NCT00364923|Primary|Response Rate Per Independent Central Review|Patient response to treatment was determined by independent central review using International Workshop Criteria (IWC). Results present the best overall response. The initial response assessment was scheduled at week 7 (prior to Cycle 2) and then prior to every even-numbered cycle (every 14 weeks) for up to two years after first dose.|Response was assessed at 7 weeks (prior to Cycle 2) and then prior to every other even-numbered cycle (every 14 weeks) until disease progression or death for up to 2 years after initial dose|Analysis was per protocol and was based on number of patients (pts) who responded in the evaluable population. The evaluable population consisted of all pts who received at least one dose of pralatrexate and had an eligible peripheral T-cell lymphoma (PTCL) histopathological subtype confirmed by central pathology review.||of Patients who Responded|||Number
726558|NCT00364949|Primary|Infant Birth Weight (Male and Female)||birth|Birth weight of the male and female infants.||gram||Standard Deviation|Mean
726559|NCT00364949|Primary|Dehydroepiandrosterone Level in Female Offspring||cord blood|The number of participants analyzed only included the levels of the female offspring.||ng/ml||Standard Deviation|Mean
726560|NCT00364949|Primary|Dihydrotestosterone Level in Female Offspring||cord blood|The number of participants analyzed only included the levels of the female offspring.||pg/ml||Standard Deviation|Mean
726561|NCT00364949|Primary|17-hydroxyprogesterone Level in Female Offspring||cord blood|The number of participants analyzed only included the levels of the female offspring.||ng/dl||Standard Deviation|Mean
726562|NCT00364949|Primary|Testosterone Level in Female Offspring||cord blood|The number of participants analyzed only included the levels of the female offspring.||ng/dl||Standard Deviation|Mean
726563|NCT00364949|Primary|Androstenedione Level in Female Offspring||cord blood|The number of participants analyzed only included the levels of the female offspring.||ng/dl||Standard Deviation|Mean
726564|NCT00364949|Primary|Estradiol Level in Female Offspring|The blood that were analyzed were taken from cord blood and not from the offspring.|One time sampling from the cord blood|The number of the participants analyzed only included the levels for the female offspring.||pg/ml||Standard Deviation|Mean
726565|NCT00365053|Secondary|Histone Acetylation by IHC and Western Blotting|Summarized with contingency tables or scatterplots, and with quantitative measures of agreement.|At baseline and at 4 hours after last dose of PXD101 on day 5||||||
726566|NCT00365053|Secondary|Apoptosis by TUNEL Assay|Summarized with contingency tables or scatterplots, and with quantitative measures of agreement.|At baseline||||||
726567|NCT00365053|Secondary|Toxicity Profile as Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.|Toxicity information recorded will include the type, severity, time of onset, time of resolution, and the probable association with the study regimen. Tables will be constructed to summarize the observed incidence by severity and type of toxicity. Toxicity will be monitored on an ongoing basis according to guidelines based on the sequential probability ratio test.|Up to 3 years||||||
726568|NCT00365053|Secondary|Time to Progression|Estimated using the product-limit method of Kaplan and Meier.|Up to 3 years|||Months||95% Confidence Interval|Mean
726570|NCT00365053|Primary|Objective Tumor Response Rate According to the Response Evaluation Criteria in Solid Tumors (RECIST) Committee|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT, MRI or X-ray: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Up to 3 years|||percentage of participants|||Number
726571|NCT00365105|Secondary|Utility and Cost Effectiveness of the Use of Radiopharmaceuticals and Bisphosphonates as Measured by the EuroQol-5 Dimension (EQ-5D)||From pre-treatment to 1 year||||||
726572|NCT00365105|Secondary|Changes in Pain Control as Measured by Brief Pain Inventory (BPI)||From pre-treatment to 1 year||||||
726573|NCT00365105|Secondary|Changes in Quality of Life as Measured by FACT-G||From pre-treatment to 1 year||||||
726574|NCT00365105|Secondary|Overall Survival||From randomization to date of death or last follow-up. Analysis occurs at the same time as the primary outcome.||||||
726575|NCT00365105|Secondary|SRE Rate at 1 Year||From randomization to 1 year||||||
726576|NCT00365105|Primary|Time to Development of a Malignant Skeletal-related Events (SRE)|Median Time to development of a malignant skeletal related event (SRE), which is defined as a pathological bone fracture, spinal cord compression, surgery to bone or radiation to bone is estimated using Kaplan-Meier method. The time of failure was measured from date of date of randomization to the date of a documented SRE. The analysis was planned to occur after 257 SRE have been observed, unless the criteria for early stopping are met.|From randomization to date of SRE development|All eligible patients who started study treatment.||months||95% Confidence Interval|Median
726577|NCT00365144|Secondary|Proportion of Patients With ≥ 25% Decline in Serum CA19-9 Biomarker||21 weeks||12/2013||||
726578|NCT00365144|Secondary|Time to Tumor Progression|Time to tumor progression (TTP) was defined as the time from initial therapy to the first objective documentation of tumor progression (for patients with measurable disease) or to the data of death, if death was ascribed to progression of disease. Patients initially without measurable disease were included in the analysis based either on the appearance of new measurable lesions or on strongly suggestive radiographic evidence of progression of non-measurable disease). Participants were followed for tumor progression; the longest duration without progression was 132 days.|132 days||12/2013||||
726579|NCT00365144|Secondary|Objective Response as Measured by RECIST Criteria|Participants experiencing objecting response, per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|21 weeks|||participants|||Number
726580|NCT00365144|Primary|Safety and Toxicity|Treatment associated toxicities. Adverse event assessments were performed on day 1 of each treatment cycle and at the end of treatment; the longest duration of treatment was 7 cycles (x 3 weeks)|21 weeks|||participants|||Number
726581|NCT00365144|Primary|Overall Survival Rate at 6 Months|Number of participants alive at 6 months|6 months|All participants were followed for survival||participants|||Number
726582|NCT00365209|Secondary|Number of Participants at Each Adverse Event Grade Level||Baseline to 30 days|These participants completed the study. The data is from the final dataset which was available in 2013 following the publication.||participants|||Number
726583|NCT00365209|Secondary|Post-treatment Curcumin Conjugates Plasma Concentrations|Post-treatment curcumin conjugate concentrations will be measured directly from the subject’s plasma and then the change in concentrations after the last dose of study drug will be measured. Concentrations will be measured and statistically evaluated by paired t-test or Wilcoxon matched-pairs signed-ranks test, as appropriate.|At 30 day|Samples from 19 participants in the 4g curcumin arm were assayed. Detectable levels of curcumin in plasma were found in 19 participants in the 4g arm; therefore, 19 samples are reported here. Samples from participants in the 2g curcumin arm were not collected due to a delayed decision resulting with protocol modification and resource restrictions.||µg/mL|Participants|Standard Deviation|Mean
726584|NCT00365209|Secondary|Baseline Curcumin Conjugates Plasma Concentrations|Baseline curcumin conjugate concentrations will be measured directly from the subject’s plasma and then the change in concentrations after the last dose of study drug will be measured. Concentrations will be measured and statistically evaluated by paired t-test or Wilcoxon matched-pairs signed-ranks test, as appropriate.|Baseline|Samples from 19 participants in the 4g curcumin arm were assayed. Detectable levels of curcumin in plasma were found in 19 participants in the 4g arm; therefore, 19 samples are reported here. Samples from participants in the 2g curcumin arm were not collected due to a delayed decision resulting with protocol modification and resource restrictions.||µg/mL|Participants|Standard Deviation|Mean
726585|NCT00365209|Secondary|Post-treatment Curcumin Conjugates Concentration in Rectal Mucosa|If detectable in the rectal mucosa, it is predicted that curcumin concentrations and potentially curcumin conjugate concentrations will be associated with reduction in PGE2 and 5-HETE measured from colorectal mucosal biopsies. Pearson correlation coefficients between changes in baseline levels in these 2 parameters and curcumin concentration in rectal mucosa will be calculated. Endpoints may be log transformed as appropriate prior to analysis.|At 30 day|The analysis is based on 39 participants (21 participants from 2g curcumin group and 18 participatns from 4g curcumin group). In 2g group, a total of 13 samples with detectable levels were analyzed. In 4g group, a total of 12 samples with detectable levels were analyzed.||µg/g protein|Participants|Standard Deviation|Mean
726586|NCT00365209|Secondary|Baseline Curcumin Conjugates Concentration in Rectal Mucosa|If detectable in the rectal mucosa, it is predicted that curcumin concentrations and potentially curcumin conjugate concentrations will be associated with reduction in PGE2 and 5-HETE measured from colorectal mucosal biopsies. Pearson correlation coefficients between changes in baseline levels in these 2 parameters and curcumin concentration in rectal mucosa will be calculated. Endpoints may be log transformed as appropriate prior to analysis.|Baseline|Samples from 21 participants in the 2g curcumin arm and 19 participants in the 4g curcumin arm were sent to be assayed. Detectable levels of curcumin conjugates in rectal mucosa were found in 0 participants in the 2g arm and 1 participant on the 4g arm. Therefore, 0 samples from the 2g arm and 1 sample from the 4g arm are reported here.||µg/g protein|Participants|Standard Deviation|Mean
727229|NCT00362180|Secondary|Baseline Low-Density Lipoprotein Cholesterol|Samples were taken following overnight fast.|Baseline|Full analysis set||mg/wk||Inter-Quartile Range|Median
726587|NCT00365209|Secondary|Post-treatment Curcumin Plasma Concentrations|Baseline curcumin conjugate concentrations will be measured directly from the subject’s plasma and then the change in concentrations after the last dose of study drug will be measured. Concentrations will be measured and statistically evaluated by paired t-test or Wilcoxon matched-pairs signed-ranks test, as appropriate.|At 30 day|Samples from 19 participants in the 4g curcumin arm were assayed. Detectable levels of curcumin in plasma were found in 2 participants in the 4g arm; therefore, 2 samples are reported here. Samples from participants in the 2g curcumin arm were not collected due to a delayed decision resulting with protocol modification and resource restrictions.||µg/mL|Participants|Standard Deviation|Mean
726588|NCT00365209|Secondary|Baseline Curcumin Plasma Concentrations|Baseline curcumin conjugate concentrations will be measured directly from the subject’s plasma and then the change in concentrations after the last dose of study drug will be measured. Concentrations will be measured and statistically evaluated by paired t-test or Wilcoxon matched-pairs signed-ranks test, as appropriate.|Baseline|Samples from 19 participants in the 4g curcumin arm were assayed. Detectable levels of curcumin in plasma were found in 4 participants in the 4g arm; therefore, 4 samples are reported here. Samples from participants in the 2g curcumin arm were not collected due to a delayed decision resulting with protocol modification and resource restrictions.||µg/mL|Participants|Standard Deviation|Mean
726589|NCT00365209|Secondary|Post-treatment Curcumin Concentration in Rectal Mucosa|If detectable in the rectal mucosa, it is predicted that curcumin concentrations and potentially curcumin conjugate concentrations will be associated with reduction in PGE2 and 5-HETE measured from colorectal mucosal biopsies. Pearson correlation coefficients between changes in baseline levels in these 2 parameters and curcumin concentration in rectal mucosa will be calculated. Endpoints may be log transformed as appropriate prior to analysis.|At 30 day|The analysis is based on 39 participants (21 participants from 2g curcmin, and 18 participants from 4 g curcumin). In 2g group, a total of 5 samples with detectable levels were analyzed. In 4g group, a total of 3 samples with detectable levels were analyzed.||µg/g protein|Participants|Standard Deviation|Mean
726590|NCT00365209|Secondary|Baseline Curcumin Concentration in Rectal Mucosa|If detectable in the rectal mucosa, it is predicted that curcumin concentrations and potentially curcumin conjugate concentrations will be associated with reduction in PGE2 and 5-HETE measured from colorectal mucosal biopsies. Pearson correlation coefficients between changes in baseline levels in these 2 parameters and curcumin concentration in rectal mucosa will be calculated. Endpoints may be log transformed as appropriate prior to analysis.|Baseline|Samples from 21 participants in the 2g curcumin arm and 18 participants in the 4g curcumin arm were sent to be assayed. Detectable levels of curcumin in rectal mucosa were found in 1 participant in the 2g arm and none in participants on the 4g arm. Therefore, only 1 sample from the 2g arm and 0 samples from the 4g arm are reported here.||µg/g protein|Participants|Standard Deviation|Mean
726591|NCT00365209|Secondary|Proliferation by Ki-67 Immunohistochemical Assay (IHC) in Normal Mucosa - Distal Third||At 30 day|The analysis is based on participants whose data are evaluable and available. Stage1 2 g curcumin: (N = 22 participants), Stage2 4 g curcumin: (N = 19 participants)||percentage of labeled cells||Standard Deviation|Mean
726592|NCT00365209|Secondary|Proliferation by Ki-67 Immunohistochemical Assay (IHC) in Normal Mucosa - Distal Third||Baseline|The analysis is based on participants whose data are evaluable and available. Stage1 2 g curcumin: (N = 22 participants), Stage2 4 g curcumin: (N = 17 participants)||percentage of labeled cells||Standard Deviation|Mean
726593|NCT00365209|Secondary|Proliferation by Ki-67 Immunohistochemical Assay (IHC) in Normal Mucosa - Middle Third||At 30 day|The analysis is based on participants whose data are evaluable and available. Stage1 2 g curcumin: (N = 22 participants), Stage2 4 g curcumin: (N = 19 participants)||percentage of labeled cells||Standard Deviation|Mean
726594|NCT00365209|Secondary|Proliferation by Ki-67 Immunohistochemical Assay (IHC) in Normal Mucosa - Middle Third||Baseline|The analysis is based on participants whose data are evaluable and available. Stage1 2 g curcumin: (N = 22 participants), Stage2 4 g curcumin : (N = 17 participants).||percentage of labeled cells||Standard Deviation|Mean
726595|NCT00365209|Secondary|Proliferation by Ki-67 Immunohistochemical Assay (IHC) in Normal Mucosa - Proximal Third||At 30 day|The analysis is based on participants whose data are evaluable and available. Stage1 2 g crucumin: (N = 22 participants), Stage2 4 g curcumin: (N = 19 participants)||percentage of labeled cells||Standard Deviation|Mean
726596|NCT00365209|Primary|Post-treatment in Prostaglandin E2 (PGE2) Within Aberrant Crypt Foci (ACF)|Post-treatment prostaglandin E2 (PGE2) values found in rectal aberrant crypt foci (ACF) tissue|At 30 day|The analysis is based on participants whose data are evaluable and available. Stage1 2g curcumin: (N = 21 participants), Stage2 4 g curcumin: (N = 19 participants)||µg/g protein||Standard Deviation|Mean
726597|NCT00365209|Secondary|Proliferation by Ki-67 Immunohistochemical Assay (IHC) in Normal Mucosa - Proximal Third||Baseline|The analysis is based on participants whose data are evaluable and available. Stage1 2 g curcumin: (N = 22 participants), Stage2 4 g curcumin: (N = 17 participants)||percentage of labeled cells||Standard Deviation|Mean
726598|NCT00365209|Secondary|Changes in Total Aberrant Crypt Foci (ACF) Number|Changes in total aberrant crypt foci (ACF) number = Number of ACF at pre-treatment - Number of ACF at post-treatment|Baseline to 30 days|The analysis is based on participants whose data are evaluable and available. Stage1 2 g curcumin: (N = 22 participants), Stage2 4 g curcumin: (N = 19 participants)||Number of ACF||Full Range|Median
726599|NCT00365209|Secondary|Change in Cyclooxygenases (COX-1, COX-2), and Lipoxygenase (5-LOX) Protein Abundance|The protein levels for each enzyme will be expressed as an absolute change from baseline and graphed against % change of its enzyme product in the same individual. The degree of correlation between these parameters will be assessed by either Pearson’s correlation coefficient or Spearman’s rank order correlation coefficient.|Baseline to 30 days|There is not enough tissue for the analysis, so no data is provided.|||||
726600|NCT00365209|Secondary|Post-treatment in 5-hydroxy-eicosatetraenoic Acid (5-HETE) Level in Normal Mucosa|Post-treatment 5-hydroxy-eicosatetraenoic acid (5-HETE) values found in normal mucosa rectal tissue|At 30 day|The analysis is based on participants whose data are evaluable and available. Stage1 2 g curcumin: (N = 21 participants), Stage2 4 g curcumin: (N = 19 participants)||µg/g protein||Standard Deviation|Mean
727230|NCT00362180|Secondary|Percent Change in Apolipoprotein B From Baseline to Day 99|Samples were taken following an overnight fast.|Day 26 and Day 99|Full analysis set with last observation carried forward.||percent change||Inter-Quartile Range|Median
726601|NCT00365209|Secondary|Baseline in 5-hydroxy-eicosatetraenoic Acid (5-HETE) Level in Normal Mucosa|Baseline 5-hydroxy-eicosatetraenoic acid (5-HETE) values found in normal mucosa rectal tissue|Baseline|The analysis is based on participants whose data are evaluable and available. Stage1 2 g curcumin: (N = 21 participants), Stage2 4 g curcumin: (N = 19 participants)||µg/g protein||Standard Deviation|Mean
726602|NCT00365209|Secondary|Post-treatment in Prostaglandin E2 (PGE2) Level in Normal Mucosa|Post-treatment prostaglandin E2 (PGE2) values found in normal mucosa rectal tissue|At 30 day|The analysis is based on participants whose data are evaluable and available. Stage1 2 g curcumin: (N = 21 participants), Stage2 4 g curcumin: (N = 19 participants)||µg/g protein||Standard Deviation|Mean
726603|NCT00365209|Secondary|Baseline in Prostaglandin E2 (PGE2) Level in Normal Mucosa|Baseline prostaglandin E2 (PGE2) values found in normal mucosa rectal tissue|Baseline|The analysis is based on participants whose data are evaluable and available. Stage1 2 g curcumin: (N = 21 participants), Stage2 4 g curcumin: (N = 19 participants)||µg/g protein||Standard Deviation|Mean
726604|NCT00365209|Secondary|Post-treatment in 5-hydroxy-eicosatetraenoic Acid (5-HETE) Within Aberrant Crypt Foci (ACF)|Post-treatment 5-hydroxy-eicosatetraenoic acid (5-HETE) values found in rectal aberrant crypt foci (ACF) tissue|At 30 Day|The analysis is based on participants whose data are evaluable and available. Stage1 2 g curcumin: (N = 21 participants), Stage2 4 g curcumin: (N = 19 participants)||µg/g protein||Standard Deviation|Mean
726605|NCT00365209|Secondary|Baseline in 5-hydroxy-eicosatetraenoic Acid (5-HETE) Within Aberrant Crypt Foci (ACF)|Baseline 5-hydroxy-eicosatetraenoic acid (5-HETE) values found in rectal aberrant crypt foci (ACF) tissue|Baseline|The analysis is based on participants whose data are evaluable and available. Stage1 2 g curcumin: (N = 21 participants), Stage2 4 g curcumin: (N = 19 participants)||µg/g protein||Standard Deviation|Mean
726606|NCT00365209|Primary|Baseline in Prostaglandin E2 (PGE2) Within Aberrant Crypt Foci (ACF)|Baseline prostaglandin E2 (PGE2) values found in rectal aberrant crypt foci (ACF) tissue|Baseline|The analysis is based on participants whose data are evaluable and available. Stage1 2 g curcumin: (N = 21 participants) and Stage2 4 g curcumin: (N = 19 participants)||µg/g protein||Standard Deviation|Mean
726607|NCT00365261|Secondary|Opiate Dosing From Patient Controlled Analgesia|Morphine or dilaudid dose delivered at fixed rate with optional self-administered prn boluses. Dilaudid doses were converted into morphine equivalents by multiplying the dose by 5.|2 days post dosing|||mg||Inter-Quartile Range|Median
726608|NCT00365261|Primary|Patient Self-report Data on Fatigue|Patients completed the five-item Profile of Mood States Scale, Short Form (POMS-SF) Fatigue–Inertia Scale to rate their fatigue complaints (scores range from 0 to 28; higher scores denote more fatigue).|2 days post treatment|||scores on a scale||Standard Error|Mean
726609|NCT00365261|Primary|Pain|Pain was assessed with a 10-cm visual analog scale (0 = “no pain at all”; 10 = “severe, uncontrolled pain”).|post dosing|||scores on a scale||Standard Error|Mean
726610|NCT00365274|Primary|Objective Response Rate (ORR)|Objective response rate (ORR) defined as the proportion of participants experiencing a Complete Response (CR) or Partial Response to a regimen of SGN-3- + CHOP using International Workshop Response Criteria (IWG) for Non-Hodgkin's Lymphomas (NHL). The IWG criteria (Cheson et al 2007) for a CR is a complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A PR is at least a 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase should be observed in the size of other nodes, liver or spleen, and no new sites of disease should be observed.|Up to 5 years|||percentage of participants|||Number
726611|NCT00365300|Primary|Number of Patients Withdrawn From Study Due to Lack of Efficacy.|Lack of efficacy defined as 1 or more of the following occurring during the double blind treatment-withdrawal phase: significant worsening of gastroesophageal reflux disease (GERD) symptoms frequency, a diagnostic test (e.g., endoscopy) demonstrating worsening of esophagitis, maximal antacid intake for ≥ 7 continuous days, or severe GERD symptoms based on physician’s judgment.|4 weeks double-blind|The analysis population was the Modified Intent to Treat, which included all GERD patients who completed the 4 week open-label treatment phase, were randomized into the 4 week double-blind phase, and took at least one dose of double-blind treatment.||patients|||Number
726612|NCT00365352|Secondary|Time to Onset of the First RLS Symptom From the 24-hour RLS Record Obtained at the End of Treatment (Week 12)|The time to onset of the first RLS symptoms from the 24-hour RLS Record is defined as the length of time from the start of the 24-hour assessment period (8:00 AM) to the time when 50% of participants experienced their first symptom.|Week 12|MITT Population. The number of participants assessed varies due to incomplete/missing data.||hours||95% Confidence Interval|Median
726613|NCT00365352|Secondary|Number of Participants Experiencing No RLS Symptoms in Each of the Seven 4-hour Periods From the 24-hour RLS Record at Week 12 (End of Treatment)|RLS severity ratings were summarized in 6 non-overlapping 4-hour periods beginning at 8 AM. A 4-hour period from 6 PM to 10 PM was also prospectively included to reflect the time frame when the most participants would experience their first symptoms of the day.|Week 12|MITT Population. The number analyzed represents participants within the MITT Population who reported no RLS symptoms at the end of Week 12.||participants|||Number
726614|NCT00365352|Secondary|Change From Baseline in the Overall Life-Impact Score of the RLS Quality of Life (QoL) Questionnaire at Week 12 Using LOCF|The Restless Legs Syndrome Quality of Life (RLS-QoL) questionnaire is a disease-specific, participant-rated questionnaire that assesses the impact of RLS on daily life, emotional well-being, social life, and work life of the participants. The RLS-QoL Questionnaire is presented on a 0 (lowest possible score) to 100 (highest possible score) scale. It was completed at Day 1 and at the end of Weeks 4, 8, and 12 (or Early Termination).|Baseline and Week 12|MITT Population: The number of participants assessed varies due to incomplete/missing data.||scores on a scale||Standard Deviation|Mean
726615|NCT00365352|Secondary|Change From Baseline in Sleep Quantity, an Item on the MOS Sleep Scale, at Week 12 Using LOCF|"The MOS Sleep Scale measures most constructs of sleep. The scale has a battery of questions to measure specific aspects of sleep in participants with co-morbidities. The four domains scored from the MOS Sleep Scale were sleep disturbance,' sleep quantity,' sleep adequacy, and daytime somnolence. The scores of the sleep quantity domain were measured in time (number of hours of sleep each night). The assessment was completed at Baseline (Day 1) and end of Weeks, 4, 8, and 12 (or end of Treatment)."|Baseline and Week 12|MITT Population. The number of participants assessed varies due to incomplete/missing data.||hours||Standard Deviation|Mean
726616|NCT00365352|Secondary|Change From Baseline in Sleep Adequacy, an Item on the MOS Sleep Scale, at Week 12 Using LOCF|"The MOS Sleep Scale measures most constructs of sleep. The scale has a battery of questions to measure specific aspects of sleep in participants with co-morbidities. The four domains scored from the MOS Sleep Scale were sleep disturbance,' sleep quantity,' sleep adequacy, and daytime somnolence. The scores of the sleep adequacy domain ranged from 1 to 100, with a high score indicating greater adequacy. The assessment was completed at Baseline (Day 1) and end of Weeks, 4, 8, and 12 (or end of Treatment)."|Basline and Week 12|MITT Population. The number of participants assessed varies due to incomplete/missing data.||scores on a scale||Standard Deviation|Mean
726617|NCT00365352|Secondary|Change From Baseline in the Sleep Disturbance Score, an Item on the MOS Sleep Scale, at Week 12 Using LOCF|"The MOS Sleep Scale measures most constructs of sleep. The scale has a battery of questions to measure specific aspects of sleep in participants with co-morbidities. The four domains scored from the MOS Sleep Scale were sleep disturbance,' sleep quantity,' sleep adequacy, and daytime somnolence. The scores of the sleep disturbance domain ranged from 1 to 100, with a high score indicating greater impairment of sleep. The assessment was completed at Baseline (Day 1) and end of Weeks, 4, 8, and 12 (or end of Treatment)."|Baseline and Week 12|MITT Population. The number of participants assessed varies due to incomplete/missing data.||scores on a scale||Standard Deviation|Mean
726618|NCT00365352|Secondary|Change From Baseline in the Daytime Somnolence Score, an Item on the Medical Outcomes Study (MOS) Sleep Scale, at Week 12 Using LOCF|"The MOS Sleep Scale measures most constructs of sleep. The scale has a battery of questions to measure specific aspects of sleep in participants with co-morbidities. The four domains scored from the MOS Sleep Scale were sleep disturbance,' sleep quantity,' sleep adequacy, and daytime somnolence. The scores of the daytime somnolence domain ranged from 1 to 100, with a high score indicating greater daytime somnolence. The assessment was completed at Baseline (Day 1) and end of Weeks, 4, 8, and 12 (or end of Treatment)."|Baseline and Week 12|MITT Population. The number of participants assessed varies due to incomplete/missing data.||scores on a scale||Standard Deviation|Mean
726619|NCT00365352|Secondary|Change From Baseline in the Profile of Mood State (POMS) Scale at Week 12 Using LOCF|The Profile of Mood States (POMS) Brief Form contains 30 adjectives; each participant is asked to rate the degree to which each adjective describes themselves based on how they felt during the past week including the date on which the adjective was rated. The possible ratings range from “0” (Not all all) to “4” (Extremely). The Total Mood Disturbance Score (range of 0 to 120) is obtained by summing the values of six domains. Higher scores indicate a more negative mood disturbance. The POMS was completed at Baseline (Day 1), and at the end of Weeks 4, 8, and 12 (or Early Termination).|Baseline to End of Treatment (Week 12)|MITT Population. The number of participants assessed varies due to incomplete/missing data.||scores on a scale||Standard Deviation|Mean
726620|NCT00365352|Secondary|Number of Participants Who Indicated on the Mood Assessment That Their Mood Was Much Improved or Very Much Improved at Week 12 (End of Treatment) Using LOCF|The Mood Assessment is a non-disease-specific question surveying global change in a participant's overall mood. Participants were asked to rate their overall change in mood since the start of the study by choosing a score in a range from 1 (Very Much Improved) to 7 (Very Much Worse). The assessment was completed at Day 1 and the ends of Weeks 4, 8, and 12 or (Early Termination).|Week 12|MITT Population. The number of participants assessed varies due to incomplete/missing data.||participants|||Number
726621|NCT00365352|Secondary|Number of Participants With a Rating of Excellent for the Overall Quality of Sleep in Past Week Measured by the Post-Sleep Questionnaire (PSQ) at the End of Treatment (Week 12) Using LOCF|"The Post-Sleep Questionnaire (PSQ) was designed to evaluate overall sleep quality, ability to function, and RLS symptoms' interference with sleep over the past week. Participants were asked to rate overall sleep quality (as either Excellent, Reasonable, or Poor), ability to function, number of nights with RLS symptoms, number of nights awakened by RLS symptoms, and the number of hours spent awake due to RLS symptoms over the past week."|End of Treatment (Week 12)|MITT Population. The number of participants assessed varies due to incomplete/missing data.||participants|||Number
726622|NCT00365352|Secondary|Number of Participants Classified as Responders to Treatment Based on the Participant-Rated CGI of Improvement at Week 1 and Week 12 (End of Treatment)|The CGI-I scale is a standardized tool that is widely used in psychopharmacologic trials. For the CGI-I, the investigator was asked to rate the participant’s overall change in RLS symptoms from Baseline. Scores ranged from 1 (very much improved) to 7 (very much worse). Participants who were much improved (score of 2) or very much improved on the CGI-I scale at the end of treatment (Week 12) are classified as “Responders.”|Week 1 and Week 12|MITT Population. The number of participants assessed varies due to incomplete/missing data.||participants|||Number
726623|NCT00365352|Secondary|Change From Baseline in the Average Daily RLS Pain Score to Week 12 for Participants With a Baseline Pain Score of at Least 4 Using LOCF|The Average Daily RLS pain was assessed by participants reporting whether they experienced any pain associated with RLS in the last 24 hours and rating their pain levels on an 11-point numerical rating scale, with 0 being no pain and 10 the most intense pain imaginable. The assessment was performed for 7 days prior to Baseline and pre-defined visits. The change from baseline was calculated as the End of Treatment (Week 12) value minus the Baseline (Day 1) value.|Baseline and Week 12|MITT Population. The number of participants assessed varies due to incomplete/missing data.||scores on a scale||Standard Deviation|Mean
726624|NCT00365352|Secondary|Number of Participants Classified as Responders With at Least 30% and 50% Improvement in the Average Daily RLS Pain Score Using LOCF|"The Mean Daily RLS pain was assessed by participants reporting whether they experienced any pain associated with RLS in the last 24 hours and rating their pain levels on an 11-point numerical rating scale, with 0 being no pain and 10 the most intense pain imaginable. The assessment was performed for 7 days prior to Baseline and pre-defined visits A Responder is a participant with a score of much improved or very much improved on the investigator rated CGI I Scale at the end of treatment (Week 12 using LOCF)."|Week 12|MITT Population. The number of participants assessed varies due to incomplete/missing data.||participants|||Number
726665|NCT00365547|Primary|Median Time to Disease Progression|Assessed by Response Evaluation Criteria In Solid Tumor (RECIST criteria). Progression is defined as a measureable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions since baseline.|From Day 1 Until First Documented Disease Progression or Date of Death (Whichever Occurred First)|All intent-to-treat patients enrolled were analyzed. Maximum number of days was 1349.||Days||95% Confidence Interval|Mean
726625|NCT00365352|Secondary|Change From Baseline in the Average Daily RLS Pain Score at the End of Treatment (Week 12) for Participants With Pain at Baseline or the End of Week 12 Using LOCF|The Daily RLS pain score was assessed by participants reporting whether they experienced any pain associated with RLS in the last 24 hours and rating their pain levels on an 11-point numerical rating scale, with 0 being no pain and 10 the most intense pain imaginable. The assessment was performed for 7 days prior to Baseline and pre-defined study visits. The change from baseline was calculated as the End of Treatment (Week 12) value minus the Baseline (Day 1) value.|Baseline and End of Treatment (Week 12)|MITT Population. The number of participants assessed varies due to incomplete/missing data.||scores on a scale||Standard Deviation|Mean
726626|NCT00365352|Secondary|Change From Baseline to the End of Treatment in Average Daily Wake Time (Minutes) After Sleep Onset Using LOCF|Average daily wake time after sleep onset was derived from the Pittsburgh Sleep Diary (PghSD) as the mean of non-missing total hours awake during the night after falling asleep over the 7 days before each visit. The change was calculated as the end of treatment (Week 12) value minus the Baseline value.|Baseline to End of Treatment (Week 12)|MITT Popultion. The number of participants assessed varies due to incomplete/missing data.||minutes||Standard Deviation|Mean
726627|NCT00365352|Secondary|Change From Baseline to the End of Treatment in Average Daily Total Sleep Time (Hours) Using LOCF|Average daily total sleep time was derived from the Pittsburgh Sleep Diary (PghSD; an instrument with separate components to be completed [self-reported] at bedtime and waketime) as the mean of non-missing total sleep time over the 7 days before each visit, where total sleep time = [(wake up time – lights out time) – time to fall asleep – time awake during the night] in hours. The change was calculated as the end of treatment (Week 12) value minus the Baseline value.|Baseline to End of Treatment (Week 12)|MITT Population. The number of participants assessed varies due to incomplete/missing data.||hours||Standard Deviation|Mean
726628|NCT00365352|Secondary|Number of Total Responders to Treatment Based on the Investigator-Rated CGI of Improvement at the End of One Week of Treatment|"The CGI-I scale is a standardized tool that is widely used in psychopharmacologic trials. For the CGI-I, the investigator was asked to rate the participant's overall change in RLS symptoms from Baseline. Scores ranged from 1 (very much improved) to 7 (very much worse). Participants who were much improved (score of 2) or very much improved on the CGI-I scale at the end of treatment (Week 12) are classified as Responders."|End of Week 1|MITT Population. The number of participants assessed varies due to incomplete/missing data.||responders|||Number
726629|NCT00365352|Secondary|Number of Participants Classified as Investigator-rated CGI-I Scale Responders at Week 12 by RLS Treatment History Using LOCF|"The CGI-I scale is a standardized tool that is widely used in psychopharmacologic trials. For the CGI-I, the investigator was asked to rate the participant's overall change in RLS symptoms from Baseline. Scores ranged from 1 (very much improved) to 7 (very much worse). Participants who were much improved (score of 2) or very much improved on the CGI-I scale at the end of treatment (Week 12) are classified as Responders."|Basline and Week 12|Participants included in the MITT Population with a known RLS treatment history||participants|||Number
726630|NCT00365352|Secondary|Change From Baseline to the End of Week 1 in the IRLS Rating Scale Total Score Using LOCF|The IRLS Rating scale is a measure of RLS disease severity. The scale reflects the participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. Items (individually scored from 0 to 4) are included that assess the impact of symptoms on participants’ mood, daily life, and activities. The total scale score is a sum of all of the individual item scores and ranges from 0-40 points, with 40 being the most severe. The scale assesses symptoms over the week prior to measurement.|Baseline and the End of Week 1|MITT Population. The number of participants assessed varies due to incomplete/missing data.||scores on a scale||Standard Deviation|Mean
726631|NCT00365352|Secondary|Change From Baseline in the IRLS Rating Scale Total Score at Week 12 by Baseline RLS Rating Scale Total Score Category (Baseline RLS Severity) Using LOCF|The IRLS Rating scale is a measure of RLS disease severity. The scale reflects the participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. Ten items (individually scored from 0 to 4) are included that assess the impact of symptoms on participants’ mood, daily life, and activities. The total scale score is a sum of all of the individual item scores and ranges from 0-40 points, with 40 being the most severe. The scale assesses symptoms over the week prior to measurement.|Baseline (Day 1) and Week 12|MITT Population. The number of participants assessed varies due to incomplete/missing data.||scores on a scale||Standard Deviation|Mean
726632|NCT00365352|Secondary|Mean Change in the IRLS Rating Scale Total Score From Baseline at Week 12 by RLS Treatment History Using LOCF|The IRLS Rating scale is a measure of RLS disease severity. The scale reflects the participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. Ten items (individually scored from 0 to 4) are included that assess the impact of symptoms on participants’ mood, daily life, and activities. The total scale score is a sum of all of the individual item scores and ranges from 0-40 points, with 40 being the most severe. The scale assesses symptoms over the week prior to measurement.|Baseline (Day 1) and Week 12|MITT Population. The number of participants assessed varies due to incomplete/missing data.||scores on a scale||Standard Deviation|Mean
726633|NCT00365352|Secondary|The Time to Onset of the First Response to Treatment on the IRLS Rating Scale Total Score and the Investigator-rated CGI-I|The Response was defined by an IRLS Rating Scale total score at the end of Week 1 < 15 and at least a 6-point reduction from the participant's Baseline score and an investigator-rated CGI-I response of much improved or very much improved. The median time to onset is estimated using the product-limit estimation method.|Baseline (Day 1) to End of Treatment (Week 12)|MITT Population. The number of participants assessed varies due to incomplete/missing data.||weeks||95% Confidence Interval|Median
726634|NCT00365352|Secondary|Number of Participants Who Had an Onset of Response to Treatment at the End of Week 1 Based Upon the IRLS Rating Scale Total Score and the Investigator-rated CGI-I Using LOCF|The IRLS Rating scale is a measure of RLS disease severity. Items (individually scored from 0 to 4) are included that assess the impact of symptoms on participants’ mood, daily life, and activities. The total scale score is a sum of all of the individual item scores and ranges from 0-40 points, with 40 being the most severe. Response was defined by an IRLS Rating Scale total score at the end of Week 1 < 15 and at least a 6-point reduction from the participant's Baseline score and an investigator-rated CGI-I response of “much improved” or “very much improved.”|End of Week 1|MITT Population. The number of participants assessed varies due to incomplete/missing data.||participants|||Number
726635|NCT00365352|Secondary|Number of Participants Classsified as Responders on the Investigator-rated CGI-I Scale at Week 12 Using LOCF|"The CGI-I scale is a standardized tool that is widely used in psychopharmacologic trials. For the CGI-I, the investigator was asked to rate the participant's overall change in RLS symptoms from Baseline. Scores ranged from 1 (very much improved) to 7 (very much worse). Participants who were much improved (score of 2) or very much improved on the CGI-I scale at the end of treatment (Week 12) are classified as Responders."|Week 12|MITT Population. The number of participants assessed varies due to incomplete/missing data.||participants|||Number
726636|NCT00365352|Secondary|Change From Baseline to the End of Treatment (Week 12) in the IRLS Rating Scale Total Score Using LOCF|The IRLS Rating scale is a measure of RLS disease severity. The scale reflects the participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. Items (individually scored from 0 to 4) are included that assess the impact of symptoms on participants’ mood, daily life, and activities. The total scale score is a sum of all of the individual item scores and ranges from 0-40 points, with 40 being the most severe. The scale assesses symptoms over the week prior to measurement.|Baseline (Day 1) and End of Treatment (Week 12)|MITT Population. The number of participants assessed varies due to incomplete/missing data.||scores on a scale||Standard Deviation|Mean
726637|NCT00365352|Primary|"Number of Participants With a Score of Much Improved or Very Much Improved on the Investigator-rated CGI-I Scale (Response) at (Week 12) Using LOCF"|"The investigator -rated Clinical Global Impression of Improvement (CGI-I) scale is an assessment designed to allow investigators to rate the change of a participant's disease severity over time based on a seven-point scale, with a score of 1 being “very much improved,” a score of 2 being much improved, a score of 3 being minimally improved, a score of 4 being no change, a score of 5 being minimally improved,a score of 6 being much worse, and a score of 7 being “very much worse. Participants with a response of much improved or very much improved were classified as responders."|Week 12|MITT Population||participants|||Number
726638|NCT00365352|Primary|Change From Baseline in IRLS Rating Scale Total Score at Week 12 Using Last Observation Carried Forward (LOCF)|The International Restless Legs Syndrome (IRLS) Rating scale is a measure of RLS disease severity. The scale reflects the participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. Ten items (individually scored from 0 to 4) are included that assess the impact of symptoms on participants’ mood, daily life, and activities. The total scale score is a sum of all of the individual item scores and ranges from 0-40 points, with 40 being the most severe. The scale assesses symptoms over the week prior to measurement.|Baseline and Week 12|Modified Intent-to-Treat (MITT) Population: all participants in the Safety Population who also satisfied all of the following conditions: (1) completed the IRLS Rating Scale at Baseline; and (2) completed at least one on-treatment IRLS Rating Scale score during the treatment period||scores on a scale||Standard Deviation|Mean
726639|NCT00365365|Secondary|Disease-free Survival (DFS) Rate|"DFS was defined as the time from the administration of the first-dose of study medication until recurrence of tumor or death from any cause in the absence of previous documentation of tumor recurrence. DFS rate was the probability of being disease free and alive at a particular time. DFS rates were estimated using Kaplan-Meier Method, and 95% confidence intervals were computed using the method of Kalbfleisch and Prentice.
For participants who did have objective recurrence of tumor and who were still on study at the time of an analysis, or who were given antitumor treatment other than the study treatment, or who were removed from study follow-up prior to documentation of the tumor recurrence, DFS was censored at the last date the participant was known to be disease-free."|from the administration of the first-dose of study medication up to 12 months, 18 months and 24 months|Intent-to-treat population - All randomized participants||percentage of participants|Participants|95% Confidence Interval|Number
726640|NCT00365365|Secondary|Safety - Number of Participants With Adverse Events (AE)|"An adverse event was any untoward medical occurrence in a participant of the clinical investigation, regardless of the relationship to study treatment.
A serious adverse event (SAE) was an AE that at any dose (including overdose) resulted in death, was life-threatening, required inpatient hospitalization or prolonged existing hospitalization, resulted in persistent or significant disability or incapacity, was a congenital anomaly/birth defect, and/or was medically important.
Treatment-emergent adverse events (TEAE) were defined as AEs that developed or worsened in severity during the on-treatment period."|from the administration of the first dose of study medication up to 30 days after the last dose of study medication; events ongoing at the time of discontinuation were monitored in the follow-up period until resolution.|Safety population - participants who received at least one dose of study medication||participants|||Number
726641|NCT00365365|Primary|Cardiac Safety - Number of Participants With Grade 3-4 Clinical Congestive Heart Failure (CHF)|"Participants were evaluated for clinical CHF every 3 weeks during chemotherapy, every 3 months while on maintenance therapy, and every 3 months during the 2-year follow-up period. Left ventricular ejection fraction (LVEF) of CHF was assessed by multi-gated acquisition (MUGA) or echocardiogram (ECHO) performed midway through completion of chemotherapy according to a treatment-specific schedule, every 12 weeks during maintenance therapy, and at 6 and 24 months after completion of maintenance therapy.
Grade 3-4 CHF were identified through a clinical review of all study collected investigator verbatim and the Medical Dictionary for Regulatory Activities (MedDRA). The preferred terms (PT) cardiac failure congestive, cardiomyopathy, and ejection fraction decreased were associated with CHF."|from the first dose of study medication up to the end of follow-up (up to 3 yrs)|Safety population - participants who received at least one dose of study medication||participants|||Number
726642|NCT00365378|Primary|Serum Anti-HPV 16 Geometric Mean Titers|"The limit of detection of the assay was 6 mMU/ml. Samples with titer below the limit of detection were assigned a value of 3 for calculation of GMT and confidence interval. GMTs and confidence limits below the limit of detection are shown as 6.0."|Month 7|Per-protocol population: subjects must have no major protocol violations, must be seronegative to HPV 16 at Day 1 and PCR negative to HPV 16 through Month 7, and must provide serology data at Month 7||milliMerck units/ml (mMU/ml)||95% Confidence Interval|Geometric Mean
726643|NCT00365378|Primary|Incidence of HPV 16-related CIN1, CIN2 or C1N3|Cases of HPV 16-related CIN1, CIN2 or CIN3 are those with detection of HPV 16 in a cervical biopsy specimen showing pathologic evidence of CIN1, CIN2 or CIN3 together with HPV 16 detected at the visit immediately before or after the biopsy.|Through Month 48|Per-protocol population: subjects must have no major protocol violations, must be seronegative to HPV 16 at Day 1 and PCR negative to HPV 16 through Month 7, and must provide follow-up data after Month 7||Incidence per 100 person-years|||Number
726644|NCT00365378|Primary|Incidence of Persistent HPV 16 Infection|Cases of persistent infection were those with detection of HPV 16 by PCR (Polymerase chain reaction) on at least 2 consecutive visits at least 4 months apart; or detection of HPV 16 in a cervical biopsy specimen showing pathologic evidence of CIN1 (Cervical intraepithelial neoplasia), CIN2 or CIN3 together with HPV 16 detected at the visit immediately before or after the biopsy; or detection of HPV 16 on a subject's last visit.|Through Month 48|Per-protocol population: subjects must have no major protocol violations, must be seronegative to HPV 16 at Day 1 and PCR (Polymerase chain reaction) negative to HPV 16 through Month 7, and must provide follow-up data after Month 7||Incidence per 100 person-years|||Number
726645|NCT00365391|Secondary|Time to Treatment Failure|Time to treatment failure is defined to be the time from the date of randomization to the date at which the patient is removed from treatment due to progression, toxicity, or refusal.|From the date of randomization to the date at which the patient is removed from treatment due to progression, toxicity, or refusal.|All 27 patients were used in this analysis.||months||95% Confidence Interval|Median
726646|NCT00365391|Secondary|Duration of Response|Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient’s objective status is first noted to be either a CR or PR to the date progression is documented.|The date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented.|No patients were analyzed for this secondary outcome due to insufficient data.|||||
726647|NCT00365391|Secondary|Time to Disease Progression|Time to disease progression is defined as the time from registration to documentation of disease progression. Estimated using the method of Kaplan-Meier.|From registration to documentation of disease progression, up to 3 years after treatment.|All 27 patients were included in the analysis.||months||95% Confidence Interval|Median
726648|NCT00365391|Secondary|Survival Time|Survival time is defined as the time from registration to death due to any cause. Estimated using the method of Kaplan-Meier.|From registration to death due to any cause, patients are followed up to 3 years after treatment|All 27 patients were analyzed.||months||95% Confidence Interval|Median
726649|NCT00365391|Primary|Number of Patients With Confirmed Tumor Response Defined to be Either a Complete Response (CR) or Partial Response (PR).|Responses to erlotinib and bevacizumab treatment were evaluated using Response Evaluation Criteria In Solid Tumors (RECIST). A Complete Response (CR) is defined as the disappearance of all target lesions. A Partial Response (PR) is defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum of the longest diameters.|Patients were able to continue treatment indefinitely and were evaluated every cycle until discontinued treatment.|Four patients were inevaluable because they were off the study prior to first radiologic evaluation for objective response.||participants|||Number
726650|NCT00365417|Secondary|Percentage of Surgical Complications Defined as Wound Dehiscence, Infection, Seroma, Hematoma||Two (2) years||||||
726651|NCT00365417|Secondary|Overall Survival|Time from the first dose of study therapy until date of death|From the first dose of study therapy until the date of death or for a maximum of 24 months from study entry||||||
726652|NCT00365417|Secondary|Progression-free Survival|Time from the first dose of study therapy to disease progression|From the first dose of study therapy until the date of disease progression or for a maximum of 24 months from study entry||||||
726653|NCT00365417|Secondary|Cardiac Events|Events: Congestive Heart Failure; Cardiac Death|Assessments throughout; up to 18 months following study entry||||||
726654|NCT00365417|Secondary|Reported Adverse Events||Assessments throughout; final adverse event assessment is 30 days after the last dose of bevacizumab|||events|||Number
726655|NCT00365417|Secondary|Clinical Response Rate (cRR) of the Sequential Regimen|Measured by physical exam of the breast and axilla|Assessments at baseline, between the two chemotherapy regimens and following the last cycle of chemotherapy (before surgery)||||||
726656|NCT00365417|Secondary|pCR in the Breast and Nodes|Measured by no histologic evidence of invasive tumor cells in the surgical breast specimen, axillary nodes, or sentinel nodes|Assessed at the time of surgery|||participants|||Number
726657|NCT00365417|Primary|Pathologic Complete Response (pCR) in the Breast|Measured by no histologic evidence of invasive tumor cells in the surgical breast specimen|Assessed at the time of surgery|||participants|||Number
726658|NCT00365456|Primary|Change in Lumbar Spine BMD From Start of Trial Period III Until End of Trial Period III.|BMD was measured by Dual X-ray Absorptiometry (DXA).|12 months|All randomized patients made the Full Analysis Set which was used for the primary and secondary analyses according to intention-to-treat principles. One participant excluded due to missing baseline data at trial period III entry, thus no data could be carried forward for this patient. Missing values imputed by Last Observation Carried Forward.||Percentage Change||Standard Error|Least Squares Mean
726659|NCT00365508|Secondary|Rate of Compliance During the First 2 Weeks|Applied to use of the intervention (number of lozenges/day or number of patches used per week) not considering abstinence|2 weeks|Intent to treat||participants|||Number
726660|NCT00365508|Primary|24-hour Point Prevalence Abstinence at the 6-month Follow up||6-months|Intent to treat analysis (lost to follow-up = smoker)||participants|||Number
726661|NCT00365547|Secondary|Median Overall Survival|Defined as the time from the start of treatment until death due to whatever cause. For subjects alive at study completion, time to death will be censored at the time of last contact.|From Day 1 Until Death Occurred|Maximum number of days was 1349.||Days||95% Confidence Interval|Median
726662|NCT00365547|Secondary|Median Duration of Response|Defined to be the time from first documented evidence of response until the first documented sign of disease progression or death due to progressive disease. For subjects who do not progress or die, duration of response will be censored at the time of last contact.|Day of 1st Response Until Disease Progression of Death/Last Contact|Maximum number of days was 1277.||Days||95% Confidence Interval|Median
726663|NCT00365547|Secondary|Median Time to Response|Defined as the time from the start of treatment until first documented evidence of at least a partial tumor response.|From Day 1 Until Tumor Response|Maximum number of days for analysis was 104.||Days||95% Confidence Interval|Median
726664|NCT00365547|Secondary|Number of Tumor Responders|Patients that met Solid Tumor Response Criteria (RECIST) criteria for partial response (at least a 30% decrease in the sum of the longest diameters of target lesions) and complete response (disappearance of all target lesions).|From Day 1 Until Disease Progression or Date of Death (Whichever Occurred First), Up to 1 Year|||Participants|||Number
726668|NCT00365599|Primary|Number of Participants With Objective Response (OR)|The Objective Response Rate. Response and progression were evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST). Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria. For the purposes of this study, patients were evaluated for response every 8 weeks. In addition to a baseline scan, confirmatory scans were also obtained ≥ 4 weeks following initial documentation of objective response.|24 weeks|All participants||participants|||Number
726669|NCT00365716|Secondary|Incidence of HPV 6-, 11-, 16- or 18-related Persistent Infection or Disease (Cervical Intraepithelial Neoplasia, Vulvar Intraepithelial Neoplasia, Vaginal Intraepithelial Neoplasia, Adenocarcinoma in Situ, Cervical Cancer, and Genital Warts)||Through 36 Months|Per-protocol population: subjects must have no major protocol violations, must be seronegative at Day 1 and PCR negative through Month 7 to the relevant HPV type, and must provide follow-up data after Month 7||Incidence per 100 person-years|||Number
726670|NCT00365716|Primary|Number of Subjects With Injection Site Adverse Experiences||Days 1-5 following any vaccination visit|All vaccinated subjects with adverse experience follow-up.||Participants|||Number
726671|NCT00365768|Secondary|Number of Participants With Progression of Neuropathy||42 days|||participants|||Number
726672|NCT00365768|Primary|Incidence of Vincristine-induced Peripheral Neuropathy||Up to 30 weeks from baseline while on Vincristine treatment|||participants|||Number
726673|NCT00365846|Secondary|Kidney Allograft Survival||3 years|||participants|||Number
726674|NCT00365846|Secondary|Incidence of Malignancies|Number of Participants Experiencing Malignancies|3 years|||participants|||Number
726675|NCT00365846|Secondary|Incidence of Post-transplant Infection|"Event of post-transplant infection (more than one event might have been counted per participant)"|3 years|||event of infection|||Number
726676|NCT00365846|Secondary|Patient Survival||3 years|||participants|||Number
726677|NCT00365846|Secondary|Incidence of Severe Allograft Rejection ( Defined as >Banff 2A or Requiring Antibody Treatment)||3 years|||participants|||Number
726678|NCT00365846|Primary|Incidence of Allograft Rejection||3 years|||participants|||Number
726679|NCT00365859|Secondary|Change From Baseline in Children’s Yale-Brown Obsessive Compulsive Scale (CY-BOCS) Score at Week 52 (Endpoint, LOCF)|CY-BOCS is a 10-item, clinician-rated scale designed to measure the severity of obsessive-compulsive symptoms in patients below the age of 18. The scale contains 5 items pertaining to obsessions (which were not used in this trial) and 5 items pertaining to compulsions, which rated each symptom domain in terms of time spent, interference with functioning, distress, resistance, and control. Each item was rated on a 5-point scale, from 0 (no symptoms or minimum severity) to 4 (extreme symptoms or maximum severity). CY-BOCS Score is from 0 to 20. A negative change score signifies improvement.|Week 0 (Baseline), Week 52 (Endpoint, LOCF)|Efficacy Sample, LOCF. The Efficacy Sample includes all patients that had a baseline and at least one post-baseline measurement of the same scale. A total of 322 patients met this criterion based on CGI-S evaluations. Of those, 96 patients did not have post-baseline evaluations for CY-BOCS, and were excluded from the efficacy analyses.||units on a scale||Standard Deviation|Mean
726680|NCT00365859|Secondary|Mean Change From Baseline in ABC Inappropriate Speech Subscale Score at Week 52 (Endpoint, LOCF)|The ABC is an informant-based symptom checklist for assessing and classifying problem behaviors of children and adolescents with mental retardation. The 58 items are rated on a 4-point scale (0 = not at all a problem to 3 = the problem is severe in degree), and resolve into 5 subscales: (1) irritability and agitation; (2) lethargy and social withdrawal; (3) stereotypic behavior; (4) hyperactivity and noncompliance, and (5) inappropriate speech. ABC Inappropriate Speech Subscale score is from 1 to 12. A negative change score signifies improvement.|Week 0 (Baseline), Week 52 (Endpoint, LOCF)|Efficacy Sample, LOCF||units on a scale||Standard Deviation|Mean
726681|NCT00365859|Secondary|Mean Change From Baseline in ABC Social Withdrawal Scale At Week 52 (Endpoint, LOCF)|The ABC is an informant-based symptom checklist for assessing and classifying problem behaviors of children and adolescents with mental retardation. The 58 items are rated on a 4-point scale (0 = not at all a problem to 3 = the problem is severe in degree), and resolve into 5 subscales: (1) irritability and agitation; (2) lethargy and social withdrawal; (3) stereotypic behavior; (4) hyperactivity and noncompliance, and (5) inappropriate speech. ABC Social Withdrawal Subscale Score is from 0 to 48. A negative change score signifies improvement.|Week 0 (Baseline), Week 52 (Endpoint, LOCF)|Efficacy Sample, LOCF. The Efficacy Sample includes all patients that had a baseline and at least one post-baseline measurement of the same scale. A total of 322 patients met this criterion based on CGI-S evaluations. Of those, 8 patients had baseline ABC (all subscales) evaluations but no post-baseline.||units on a scale||Standard Deviation|Mean
726682|NCT00365859|Secondary|Change From Baseline in ABC Stereotypy Subscale Score at Week 52 (Endpoint, LOCF)|The ABC is an informant-based symptom checklist for assessing and classifying problem behaviors of children and adolescents with mental retardation. The 58 items are rated on a 4-point scale (0 = not at all a problem to 3 = the problem is severe in degree), and resolve into 5 subscales: (1) irritability and agitation; (2) lethargy and social withdrawal; (3) stereotypic behavior; (4) hyperactivity and noncompliance, and (5) inappropriate speech. ABC Stereotypy Subscale Score is from 0 to 21. A negative change score signifies improvement.|Week 0 (Baseline), Week 52 (Endpoint, LOCF)|Efficacy Sample, LOCF. The Efficacy Sample includes all patients that had a baseline and at least one post-baseline measurement of the same scale. A total of 322 patients met this criterion based on CGI-S evaluations. Of those, 8 patients had baseline ABC (all subscales) evaluations but no post-baseline.||units on a scale||Standard Deviation|Mean
726683|NCT00365859|Secondary|Mean Change From Baseline in ABC Hyperactivity Subscale Score at Week 52 (Endpoint, LOCF)|The ABC is an informant-based symptom checklist for assessing and classifying problem behaviors of children and adolescents with mental retardation. The 58 items are rated on a 4-point scale (0 = not at all a problem to 3 = the problem is severe in degree), and resolve into 5 subscales: (1) irritability and agitation; (2) lethargy and social withdrawal; (3) stereotypic behavior; (4) hyperactivity and noncompliance, and (5) inappropriate speech. ABC Hyperactivity Subscale Score is from 0 to 48. A negative change score signifies improvement.|Week 0 (Baseline), Week 52 (Endpoint, LOCF)|Efficacy Sample, LOCF.The Efficacy Sample includes all patients that had a baseline and at least one post-baseline measurement of the same scale. A total of 322 patients met this criterion based on CGI-S evaluations. Of those, 8 patients had baseline ABC (all subscales) evaluations but no post-baseline.||units on a scale||Standard Deviation|Mean
726684|NCT00365859|Secondary|Mean Change From Baseline in Aberrant Behavior Checklist (ABC) Irritability Score at Week 52 (Endpoint, LOCF)|The ABC is an informant-based symptom checklist for assessing and classifying problem behaviors of children and adolescents with mental retardation. The 58 items are rated on a 4-point scale (0 = not at all a problem to 3 = the problem is severe in degree), and resolve into 5 subscales: (1) irritability and agitation; (2) lethargy and social withdrawal; (3) stereotypic behavior; (4) hyperactivity and noncompliance, and (5) inappropriate speech. ABC Irritability Subscale Score is from 0 to 45. A negative change signifies improvement|Week 0 (Baseline), Week 52 (Endpoint, LOCF)|Efficacy Sample, LOCF. The Efficacy Sample includes all patients that had a baseline and at least one post-baseline measurement of the same scale. A total of 322 patients met this criterion based on CGI-S evaluations. Of those, 8 patients had baseline ABC (all subscales) evaluations but no post-baseline.||units on a scale||Standard Deviation|Mean
726685|NCT00365859|Secondary|CGI-Improvement Score at Week 52 (Endpoint, LOCF)|CGI scale is a global evaluation of improvement over time. CGI-Improvement (CGI-I) is a clinician rated assessment that evaluates improvement relative to symptoms at baseline on a a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). CGI-I Score is from 1 to 7. A lower score signifies larger improvement.|Week 52 (Endpoint, LOCF)|Efficacy Sample. The Efficacy Sample includes all patients that had a baseline and at least one post-baseline measurement of the same scale. A total of 322 patients met this criterion based on CGI-S evaluations.||units on a scale||Standard Deviation|Mean
726686|NCT00365859|Secondary|Mean Change From Baseline in Clinical Global Impression (CGI)-Severity Score at Week 52 (Endpoint, LOCF)|CGI scale is a global evaluation of improvement over time. CGI-Severity (CGI-S) is a clinician-rated assessment that evaluates the severity of a patient's condition on a 7-point scale ranging from 1 (no symptoms) to 7 (very severe symptoms). CGI-Severity score is from 1 to 7. A negative change score signifies improvement.|Week 0 (Baseline), Week 52 (Endpoint, LOCF)|Efficacy Sample, LOCF. The Efficacy Sample includes all patients that had a baseline and at least one post-baseline measurement of the same scale. A total of 322 patients met this criterion based on CGI-S evaluations.||units on a scale||Standard Deviation|Mean
726687|NCT00365859|Primary|Mean Change From Baseline By Time Period in BMI Z-Score|The Z-Score indicates how many standard deviations a person is from the population norm values. The BMI z-scores are designed to take into account the BMI that would be expected due to normal growth in children and adolescents. The BMI z-scores are by age and gender standardized values (corresponding to a normal distribution with mean 0 and a standard deviation of 1) of the actual BMI measurements, based on the Growth Charts provided by the Centers for Disease Control (CDC; see Links section of this record).|At screening (up to 42 days prior to treatment start), Week 0 (Baseline), Week 1, Week 2, Week 4, Week 8, Week 14, Week 20, Week 26, Week 34, Week 42, Week 52 (Endpoint)|Safety Sample. Subjects included in the period evaluation had a baseline and at least 1 measurement within the time period that was assessed. Patients are only counted once in each time period but can appear in multiple time periods. For those with multiple records in 1 time period, only the last record in that period is included in calculations.||Standard Deviations away from Population||Standard Deviation|Mean
726688|NCT00365859|Primary|Mean Change From Baseline in Patient Body Mass Index (BMI)|The body mass index (BMI) is a statistical measurement which compares a person's weight and height. Though it does not actually measure the percentage of body fat, it is used to estimate a healthy body weight based on subject height.|At screening (up to 42 days prior to treatment start), Week 0 (Baseline), Week 1, Week 2, Week 4, Week 8, Week 14, Week 20, Week 26, Week 34, Week 42, Week 52 (Endpoint)|Safety Sample: Endpoint - Last Observation Carried Forward (LOCF)||kg/m2||Standard Deviation|Mean
726689|NCT00365859|Primary|Mean Change From Baseline by Time Period in Body Weight Z-Score|The Z-Score indicates how many standard deviations a person is from the population norm values. The body weight z-scores are designed to take into account the amount of weight gain that would be expected due to normal growth in children and adolescents. The body weight z-scores are by age and gender standardized values (corresponding to a normal distribution with mean 0 and a standard deviation of 1) of the actual weight measurements, based on the Growth Charts provided by the Centers for Disease Control (CDC; see Links section of this record).|At screening (up to 42 days prior to treatment start), Week 0 (Baseline), Week 1, Week 2, Week 4, Week 8, Week 14, Week 20, Week 26, Week 34, Week 42, Week 52 (Endpoint)|Safety Sample. Subjects included in the period evaluation had a baseline and at least 1 measurement within the time period that was assessed. Patients are only counted once in each time period but can appear in multiple time periods. For those with multiple records in 1 time period, only the last record in that period is included in calculations.||Standard Deviations away from Population||Standard Deviation|Mean
726690|NCT00365859|Primary|Mean Change From Baseline in Patient Weight||At screening (up to 42 days prior to treatment start), Week 0 (Baseline), Week 1, Week 2, Week 4, Week 8, Week 14, Week 20, Week 26, Week 34, Week 42, Week 52 (Endpoint)|Safety Sample - Observed Cases (OC) Data Set and Endpoint - Last Observation Carried Forward (LOCF)||kg||Standard Deviation|Mean
726691|NCT00365859|Primary|Number of Potentially Clinically Relevant Vital Sign Abnormalities|Clinically significantly abnormal vital signs met age-appropriate (heart rate cohorts: ages 5-14 & ages 15+; blood pressure cohorts: ages 6-12 & ages 13-17) criterion AND represented change from pretreatment value of at least the following magnitudes: systolic blood pressure (≥130 mmHg & ≥144 mmHg w/ increase of ≥20 mmHg) or (≤117 mmHg & ≤120 mmHg w/ decrease of ≥20 mmHg); diastolic blood pressure (≥86 mmHg & ≥92 mmHg w/ increase of ≥15 mmHg) or (≤75 mm Hg & ≤80 mmHg w/ decrease of ≥15 mmHg); heart rate (140 bpm and 120 bpm w/ increase of ≥15 bpm) or (50 bpm and 50 bpm w/ decrease of ≥15 bpm).|At screening (up to 42 days prior to treatment start), Week 0 (Baseline), Week 1, Week 2, Week 4, Week 8, Week 14, Week 20, Week 26, Week 34, Week 42, Week 52 (Endpoint)|Safety Sample||Participants|||Number
726692|NCT00365859|Primary|Number of Participants With Potentially Clinically Relevant Eletrocardiograph (ECG) Abnormalities|"These abbreviations are used in the table of ECG measurements: supraventricular (SV), baseline (BL), 1 degree (1°), atrioventricular (A-V), intraventricular (IVT), symmetrical (SYM), corrected QT interval (QTc). QRS complex is a recording of a single heartbeat on ECG corresponding to the depolarization of the right and left ventricles. PR interval is measured from beginning of P wave to beginning of QRS complex. QT interval is a measure of time between start of Q wave and end of T wave in the heart's electrical cycle. ↑ = increase from baseline, ↓ = decrease from baseline, → = to"|At screening (up to 42 days prior to treatment start), Week 8, Week 26, Week 52|Safety Sample||Participants|||Number
726693|NCT00365859|Primary|Number of Participants With Potentially Clinically Relevant Laboratory Chemistry Abnormalities|Abnormal chemistry criterion values include the following: aspartate aminotransferase ≥3x upper limit of normal (ULN); alanine aminotransferase ≥3x ULN; alkaline phosphatase ≥3x ULN; lactate dehydrogenase ≥3x ULN; creatinine ≥2.0 mg/dL; uric acid, ≥10.5 mg/dL (male), ≥8.5 mg/dL (female); bilirubin (Total) ≥2.0 mg/dL; serum prolactin >ULN; creatine kinase ≥3x ULN; blood urea nitrogen ≥30 mg/dL; sodium ≤126 mEq/L or ≥156 mEq/L; potassium ≤2.5 mEq/L or ≥ 6.5 mEq/L; chloride ≤90 mEq/L or ≥118 mEq/L; calcium ≤8.2 mg/dL or ≥12 mg/dL|At screening (up to 42 days prior to treatment start), Week 8, Week 26, Week 52|Safety Sample||Participants|||Number
726694|NCT00365859|Primary|Number of Participants With Potentially Clinically Relevant Laboratory Hematology Abnormalities|Abnormal hematology criterion values include the following: hematocrit (ages 6-17, males & females) ≤33%; hemoglobin (ages 6-17, males & females) <11.3 g/dL; leukocytes ≤2800 c/mm3 or ≥16000 c/mm3; eosinophils (ages 6-17, males & females) >17%; neutrophils <15%; platelet count ≤75,000 c/mm3 or ≥700,000 c/mm3|At screening (up to 42 days prior to treatment start), Week 8, Week 26, Week 52|Safety Sample||Participants|||Number
726695|NCT00365859|Primary|Number of Participants With Potentially Clinically Relevant Laboratory Metabolic Abnormalities|Abnormal metabolic criterion values include the following: fasting serum glucose ≥115 mg/dL; non-fasting serum glucose ≥ 200 mg/dL; total cholesterol ≥240 mg/dL; LDL cholesterol ≥160 mg/dL; HDL cholesterol ≤30 mg/dL; triglycerides ≥120 mg/dL (females), ≥160 mg/dL (males)|At screening (up to 42 days prior to treatment start), Week 8, Week 26, Week 52|Safety Sample||Participants|||Number
726696|NCT00365859|Primary|Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment at Week 8, Week 26, Week 52, and Endpoint|The Barnes Akathisia Rating Scale is a 4-item scale to assess presence and severity of drug-induced akathisia, including both objective items and subjective items, together with a global clinical assessment of akathisia. Global assessment is made on a scale of 0 to 5 with comprehensive definitions provided for each anchor point on scale: 0=absent; 1=questionable; 2=mild akathisia; 3=moderate akathisia; 4=marked akathisia; 5=severe akathisia. Score has a possible range from 0 (absent) to 5 (severe akathisia). Negative change scores indicate improvement in akathisia.|Baseline, Week 8, Week 26, Week 52|Safety Sample - Observed Cases (OC) Data Set and Endpoint - Last Observation Carried Forward (LOCF)||units on a scale||Standard Deviation|Mean
726697|NCT00365859|Primary|Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) At Week 8, Week 26, and Week 52|The AIMS is an assessment of movement dysfunctions. It is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs and 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in 3 main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe). The AIMS Total Score has a possible range from 0 to 28. Negative change scores indicate improvement in movement dysfunction.|Baseline, Week 8, Week 26, Week 52|Safety Sample - Observed Cases (OC) Data Set and Endpoint - Last Observation Carried Forward (LOCF)||units on a scale||Standard Deviation|Mean
726698|NCT00365859|Primary|Mean Change From Baseline in Total Simpson-Angus Scale (SAS) At Week 8, Week 26, and Week 52|The SAS is a 10-item instrument used to evaluate the presence and severity of parkinsonian symptomatology. It is the most commonly used rating scale for Parkinsonism in clinical trials over the past 25 years. The ten items focus on rigidity rather than bradykinesia, and do not assess subjective rigidity or slowness. Items are rated for severity on a 0-4 scale, with definitions given for each anchor point. The total SAS Score has a possible range from 10 to 50. Negative change scores indicate improvement.|Baseline, Week 8, Week 26, Week 52|Safety Sample - Observed Cases (OC) Data Set and Endpoint - Last Observation Carried Forward (LOCF)||units on a scale||Standard Deviation|Mean
726699|NCT00365859|Primary|Number of Participants With Serious Adverse Events (SAEs), Treatment-Emergent Adverse Events (AEs), Deaths, AEs Leading to Discontinuation, Extra Pyramidal Syndrome (EPS)-Related AEs|Participants with Adverse Events (AEs), Deaths, Serious AEs (SAEs), and AEs leading to study discontinuation. AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|From Screening (up to 42 days prior to treatment start) through Week 52 (end of study) for SAEs; from Week 0 (Baseline) through Week 52 (End of Study) for AEs|Safety Population||Participants|||Number
726700|NCT00365872|Other Pre-specified|Number of Participants With Increase in Level of Radioactivity at Excision Per Cohort|To identify the nodes to be excised, an injection with Indium 111 (radio active dye) labeled dendritic cells (of vaccine #4) was performed 1 to 3 days prior to surgery. Patients were evenly divided to be assigned to one of three cohorts: Cohort 1, 1 day before surgery; Cohort 2, 2 days before surgery; Cohort 3, 3 days before surgery. Vaccine #4 was labeled in order to evaluate how long dendritic cells need to travel to regional draining lymphatics. Tumor resection was not delayed by this.|Up to 3 years|Participants evaluable for this measure||participants|||Number
726701|NCT00365872|Secondary|Participants With No Evidence of Disease at Follow-up|Participants who had no evidence of the disease for at least one year after the start of the treatment (time of follow-up); for at least 2 years, and for at least 3 years.|3 years|All evaluable participants available for follow-up at time of analysis.||participants|||Number
726702|NCT00365872|Secondary|Occurrence of Postoperative Wound Complications|Postoperative wound complications were defined using NCI Common Toxicity Criteria (CTC).|Up to 3 years|All evaluable participants available for follow-up at time of analysis.||participants|||Number
726703|NCT00365872|Secondary|Occurrence of Significant (>/= Grade 2) Toxicity|Toxicity assessment during combination external beam radiation therapy (EBRT)/DC neoadjuvant treatment. Toxicity was assessed according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 criteria.|Up to 3 years|All evaluable participants available for follow-up at time of analysis.||participants|||Number
726751|NCT00357877|Secondary|Cumulative Net D12FS Caries Increment|This measure was computed similar to the total net D12FS increment, but separately scored and combined transitions from the baseline to 7-month visits and from the 7- to 13-month visits, rather than simply looking at the baseline to 13-month visits.|Visit 1, 7-month follow-up, 13-month follow-up|Intention-to-Treat sample||caries increment units/13 months||Standard Error|Mean
726704|NCT00365872|Primary|Overall Response Rate (ORR)|Immune responses in patients treated with EBRT and DCs: Transient immune response = response detected at only one time point; Robust immune response = response detected at least at two time points. An individual patient was considered a responder to tumor cell lysates (TCL) or survivin if at any time point the response in the interferon gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) assay was higher than 30 spots per 2 X 10^5 cells and in the proliferation assay higher than 3,000 counts per minute (CPM) and the response in IFN-γ ELISPOT or proliferation assays to TCL or Ad-surv was more than 2 standard deviations (SD) higher than the response to the corresponding control lysate or Ad-c at the same time point and 2 SD higher than the response to the same stimuli before start of the treatment.|Up to 3 years|All evaluable participants available for follow-up at time of analysis.||participants|||Number
726705|NCT00357331|Primary|P1NP (Amino-terminal Propeptide of Type I Procollagen)|One measure of bone turnover was P1NP as a morning lab draw.|Baseline,1,3,6,12 months|The numbers analyzed reflect the number of participants evaluable at each time point.||micrograms/L||Standard Deviation|Mean
726706|NCT00357331|Secondary|Number of Participants With Stable Bone Mineral Density (BMD) Over 12 Months at All Sites.|BMD was performed at lumbar spine, total hip and femoral neck using dual-energy X-ray Absorptiometry (DXA) Hologic; Bedford, Massachusetts.|1 year|||Participants|||Count of Participants
726707|NCT00357331|Primary|Urinary-N-telopeptide|One measure of bone turnover was urinary-NTX as a second void morning urine.|Baseline,1,3,6,12 months|The numbers analyzed reflect the number of participants evaluable at each time point.||nml BCE/nmol creatinine||Standard Deviation|Mean
726708|NCT00357370|Secondary|Adjusted Mean Total Daily Dose of Insulin (TDDI) Change From Baseline at Week 12 (LOCF), Including Data After Up-titration of Insulin) - Cohort 2|Baseline TDDI was reduced by 50% prior to treatment, except 2 subjects. TDDI could be up-titrated according to prespecified criteria at Weeks 4, 6, 8, 10 and 12 in the double-blind period.|From Baseline to Week 12|Chort 2 all randomized participants who received study medication and had nonmissing TDDI values at baseline and Week 12 (LOCF). Note: participants in cohort 1 provided data to establish an acceptable safety and tolerability profile when dapagliflozin 20 mg was added to open-label oral antidiabetic agent plus insulin.||units/day||Standard Error|Mean
726709|NCT00357370|Secondary|Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) Decrease From Baseline >= 0.5% at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2|Therapeutic glycemic response is defined as HbA1c decrease from baseline >= 0.5% at Week 12. Data after insulin uptitration was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.|From Baseline to Week 12|Chort 2 all randomized participants who received study medication and had nonmissing values at baseline and Week 12 (LOCF). Note: participants in cohort 1 provided data to establish an acceptable safety and tolerability profile when dapagliflozin 20 mg was added to open-label oral antidiabetic agent plus insulin.||Participants|||Number
726710|NCT00357370|Secondary|Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <=6.5% at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2|Therapeutic glycemic response is defined as HbA1c <=6.5%. Data after insulin uptitration was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.|From Baseline to Week 12|Chort 2 all randomized participants who received study medication and had nonmissing values at baseline and Week 12 (LOCF). Note: participants in cohort 1 provided data to establish an acceptable safety and tolerability profile when dapagliflozin 20 mg was added to open-label oral antidiabetic agent plus insulin.||Participants|||Number
726711|NCT00357370|Secondary|Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2|Therapeutic glycemic response is defined as HbA1c <7.0%. Data after insulin uptitration was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.|From Baseline to Week 12|Chort 2 all randomized participants who received study medication and had nonmissing values at baseline and Week 12 (LOCF). Note: participants in cohort 1 provided data to establish an acceptable safety and tolerability profile when dapagliflozin 20 mg was added to open-label oral antidiabetic agent plus insulin.||Participants|||Number
726712|NCT00357370|Secondary|Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2|Fasting plasma glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. Data after insulin uptitration was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 6, 8, 10, and 12 in the double-blind period.|From Baseline to Week 12|Chort 2 all randomized participants who received study medication and had nonmissing FPG values at baseline and Week 12 (LOCF). Note: participants in cohort 1 provided data to establish an acceptable safety and tolerability profile when dapagliflozin 20 mg was added to open-label oral antidiabetic agent plus insulin.||mg/dL||Standard Error|Mean
726713|NCT00357370|Primary|Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2|HbA1c was measured as percent of hemoglobin by a central laboratory. Data after insulin uptitration was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 6, 8, 10, and 12 in the double-blind period.|From Baseline to Week 12|Chort 2 all randomized participants who received study medication and had nonmissing HbA1c values at baseline and Week 12 (LOCF). Note: participants in cohort 1 provided data to establish an acceptable safety and tolerability profile when dapagliflozin 20 mg was added to open-label oral antidiabetic agent plus insulin.||% of hemoglobin||Standard Error|Mean
726714|NCT00357396|Primary|Overall Objective Response||2 years|||participants|||Number
726773|NCT00357968|Secondary|Myonecrosis Measure: Cardiac Troponin 18 to 24 Hours After the Loading Dose|Mean troponin level at 18 to 24 hours after the loading dose. Troponin is a biomarker for myonecrosis.|18 to 24 hours after loading dose|Includes patients who received a loading dose, underwent PCI, did not receive a GP IIb/IIIa antagonist, and had an evaluable troponin measure.||ng/ml||Standard Deviation|Mean
726715|NCT00357500|Secondary|Best Response|As appropriate for tumor type and location, gadolinium-enhanced MRI and other imaging modalites were used to assess response. Best response was regarded as best response at any single assessment. Response was defined as follows: complete resolution of all demonstrable tumor, complete response (CR); >/=50% decrease in the product of the 2 maximum perpendicular diameters relative to the baseline evaluation, partial response (PR); <50% decrease and <25% increase in product of diameters, stable disease (SD); and >/=25% increase in product of diameters, development of new areas of disease, or disease-attributable clinical deterioration or death, progressive disease (PD). For patients with leukemia PD was defined as >/=25% or >/=5,000 cells/mm3 increase in number of circulating cells, development of extramedullary disease, or other clinical evidence of progression.|Assessed at study entry, every 9 weeks on treatment and at treatment discontinuation, up to 27 weeks.|||participants|||Number
726716|NCT00357500|Secondary|27-Week Overall Survival|27-week overall survival is the probability of patients remaining alive at 27-weeks from study entry estimated using with Kaplan-Meier methods.|Assessed every 9 weeks on treatment and annually until death or initiation of new therapy, up to 27 weeks.|The analysis dataset is comprised of all treated patients.||Probability||95% Confidence Interval|Number
726717|NCT00357500|Secondary|27-Week Progression-Free Survival|27-week progression-free survival is the probability of patients remaining alive and progression-free at 27-weeks from study entry estimated using Kaplan-Meier methods. As appropriate for tumor type and location, gadolinium-enhanced MRI and other imaging modalites were used to assess response. Progressive disease was defined as >/=25% increase in product of diameters, development of new areas of disease, or disease-attributable clinical deterioration or death, progressive disease. For patients with leukemia PD was defined as >/=25% or >/=5,000 cells/mm3 increase in number of circulating cells, development of extramedullary disease, or other clinical evidence of progression.|Assessed every 9 weeks on treatment and annually until death or initiation of new therapy, up to 27 weeks.|The analysis dataset is comprised of all treated patients.||Probability||95% Confidence Interval|Number
726718|NCT00357500|Primary|Therapy Completion Rate|Proportion of patients alive at 27 weeks without progressive disease (PD) and having tolerated therapy. As appropriate for tumor type and location, gadolinium-enhanced MRI and other imaging modalites were used to assess response. Progressive disease was defined as >/=25% increase in product of diameters, development of new areas of disease, or disease-attributable clinical deterioration or death, progressive disease. For patients with leukemia PD was defined as >/=25% or >/=5,000 cells/mm3 increase in number of circulating cells, development of extramedullary disease, or other clinical evidence of progression.|27 weeks|The analysis dataset is comprised of all treated patients.||proportion of patients||90% Confidence Interval|Number
726719|NCT00357552|Secondary|Change in CD4+ Cell Counts From Study Entry to Week 104||Study entry and week 104|All participants enrolled.||cells/mm^3||Inter-Quartile Range|Median
726720|NCT00357552|Secondary|Proportion of Participants With Plasma HIV-1 RNA Levels < 400 Copies/mL From Baseline to Week 104||At Weeks 0, 12, 16, 20, 24, 32, 40, 48, 56, 68, 80, 92, 104|All participants enrolled.||proportion of participants|||Number
726721|NCT00357552|Secondary|HIV-1 Viral Sequence as Ascertained From Paired DBS and Plasma|HIV-1 viral sequencing as ascertained from paired DBS and plasma|At study entry and virologic failure|HIV-1 viral sequence testing in DBS was not performed|||||
726722|NCT00357552|Secondary|Level of HIV-1 RNA as Ascertained From Paired DBS and Plasma|Proportion of DBS samples with HIV-1 RNA level <= 400 copies/mL, proportion of plasma samples with HIV-1 RNA level <= 400 copies/mL and proportion of paired DBS and plasma samples that are concordant (both <= 400 copies/mL or both > 400 copies/mL). Results are pooled over 4 different storage temperature conditions (-80C, -20C, 4C and room temperature).|At study entry and weeks 24 and 48|Participants with DBS samples available at study entry, week 24 or 48, with corresponding plasma HIV-1 RNA levels.||proportion of samples|paired DBS and plasma samples||Number
726723|NCT00357552|Secondary|Time to First New Grade 3 or 4 Sign or Symptom or Laboratory Toxicity Following LPV/r Intensification|25th percentile in weeks from study entry to first new grade 3 or 4 sign or symptom or laboratory toxicity following LPV/r intensification. Grading of adverse events (signs and symptoms and laboratory toxicities) was according to Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, December 2004.|From LPV/r intensification to week 104|All participants enrolled.||weeks||95% Confidence Interval|Number
726724|NCT00357552|Secondary|Percentage of Subjects Reporting Not Skipping Medications in the Last Month.|The percentage of subjects reporting never missing medications in the last month.|Study entry and weeks 2, 4, 8, 12, 16, 20, and 24|All participants enrolled.||percentage of subjects with data|||Number
726725|NCT00357552|Secondary|Number of Subjects With at Least One New PI-associated Resistance Mutation at Time of Virologic Failure.|Number of subjects with at least one new PI-associated resistance mutation at time of virologic failure. Resistance interpretations used the May 6, 2009 Stanford algorithm.|At time of virologic failure|16 subjects met the criteria for endpoint failure; 15 subjects were virologic failures and 1 subject intensified prior to virologic failure. Of the 15 subjects with virologic failure, 11 had sequence data, and sequencing failed for 4.||participants|||Number
726726|NCT00357552|Secondary|Number of Participants With Study-targeted Diagnoses and Clinical Events|Cardiac disorders, Infections and infestations, Metabolism and nutrition disorders, Neoplasms benign, malignant and unspecified (including cysts and polyps), Pregnancy, puerperium and perinatal conditions, Vascular disorders, were specified a priori as study-targeted events by the study chair.|Study entry to week 104|All participants enrolled.||participants|||Number
726727|NCT00357552|Secondary|Time to Treatment Failure, Defined as the First Occurrence of Death, Disease Progression, or Virologic Failure.|25th percentile in weeks from study entry to treatment failure, defined as the first occurrence of death, disease progression, or virologic failure. Virologic failure was defined as HIV-1 >= 400 copies/mL after week 24 or 2 consecutive HIV-1 RNA >= 400 copies/mL after week 16 following suppression on LPV/r monotherapy.|Study entry to Week 104|All participants enrolled.||weeks||95% Confidence Interval|Number
726728|NCT00357552|Secondary|Number of Screened Subjects With at Least One NNRTI, or NRTI-associated Resistance Mutation at A5230 Screening.|Number of screened subjects with at least one NNRTI, or NRTI-associated resistance mutation. Resistance interpretations used the November 30, 2011 Stanford algorithm.|Screening|All screened individuals.||number of screened subjects|||Number
727231|NCT00362180|Secondary|Baseline Apolipoprotein B|Samples were taken following an overnight fast.|Baseline|Full analysis set||mg/wk||Inter-Quartile Range|Median
726729|NCT00357552|Primary|Probability of Grade 3 or 4 Sign or Symptom, or Laboratory Toxicity Over 24 Weeks on Study.|Probability of Grade 3 or 4 sign or symptom, or laboratory toxicity over 24 weeks on study using Kaplan-Meier estimates of the cumulative probability of Grade 3 or 4 sign or symptom, or laboratory toxicity at week 24. Grading of adverse events (signs and symptoms and laboratory toxicities) was according to Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, December 2004.|From study entry to week 24|All enrolled individuals.||cumulative probability of grade 3 or 4||95% Confidence Interval|Number
726730|NCT00357552|Primary|Percentage of Enrolled Participants With Virologic Success at Week 24 on LPV/r Monotherapy|Virologic success at week 24 on LPV/r monotherapy was defined as remaining on LPV/r monotherapy at week 24 without prior virologic failure. Virologic failure was met with either of these two conditions: (i) failure to suppress HIV-1 RNA to < 400 copies/mL by week 24 or (ii) confirmed HIV-1 RNA >= 400 copies/mL after confirmed HIV-1 RNA < 400 copies/mL.|From study entry to week 24|All enrolled individuals.||percentage of enrolled subjects||90% Confidence Interval|Number
726772|NCT00357955|Primary|Percentage of Participans With A1c<7%, LDL Cholesterol <100mg/dL, Systolic Blood Pressure <130mm Hg and Diastolic Blood Pressure <80 mm Hg|The major outcome was the percentage of participants who attain the target goals for A1C, blood pressure,and ldl cholesterol lipids set by the American Diabetes Association guidelines, defined as A1C <7%, SBP <130 mm Hg, diastolic blood pressure (DBP) <80 mm Hg, and LDL cholesterol <100 mg/dL (2.6 mmol/L).|4 months|||percentage|||Number
726738|NCT00357734|Primary|Number of Other Adverse Events (AEs) Related to ZD1839|Assessment of the long-term safety profile of ZD1839 therapy by assessing the incidence of adverse events. Any adverse events (AEs) and serious adverse events (SAEs) occurring during treatment and any SAEs occurring within 30 days after stopping the trial drug must be followed to resolution unless, in the investigator’s opinion, the condition is unlikely to resolve because of the patient’s underlying disease.|Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until 30 days after the last dose of study treatment or 30 days after last visit (up to approximately 120 months)|||number of other AEs related to ZD1839|||Number
726739|NCT00357734|Primary|Number of Other Adverse Events (AEs)|Assessment of the long-term safety profile of ZD1839 therapy by assessing the incidence of adverse events. Any adverse events (AEs) and serious adverse events (SAEs) occurring during treatment and any SAEs occurring within 30 days after stopping the trial drug must be followed to resolution unless, in the investigator’s opinion, the condition is unlikely to resolve because of the patient’s underlying disease.|Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until 30 days after the last dose of study treatment or 30 days after last visit (up to approximately 120 months)|||number of other AEs|||Number
726740|NCT00357734|Primary|Number of Serious Adverse Events (SAEs) Related to ZD1839|Assessment of the long-term safety profile of ZD1839 therapy by assessing the incidence of adverse events. Any adverse events (AEs) and serious adverse events (SAEs) occurring during treatment and any SAEs occurring within 30 days after stopping the trial drug must be followed to resolution unless, in the investigator’s opinion, the condition is unlikely to resolve because of the patient’s underlying disease.|Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until 30 days after the last dose of study treatment or 30 days after last visit (up to approximately 120 months)|||Number of SAEs related to ZD1839|||Number
726741|NCT00357734|Primary|Number of Serious Adverse Events (SAEs)|Assessment of the long-term safety profile of ZD1839 therapy by assessing the incidence of adverse events. Any adverse events (AEs) and serious adverse events (SAEs) occurring during treatment and any SAEs occurring within 30 days after stopping the trial drug must be followed to resolution unless, in the investigator’s opinion, the condition is unlikely to resolve because of the patient’s underlying disease|Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until 30 days after the last dose of study treatment or 30 days after last visit (up to approximately 120 months)|||number of SAEs|||Number
726742|NCT00357734|Secondary|Overall Survival (OS)||From randomization until death (up to 120 months)|||Months||95% Confidence Interval|Median
726743|NCT00357734|Secondary|Progression-free Survival (PFS)|Objective disease progressing was assessed using the previous cancer response criteria in the parent ZD1839 trial: ie Southwest Oncology Group (SWOG) tumor response criteria, as a 50% increase or an increase of 10 cm2 (whichever is smaller) in the sum of products of all measurable lesions from the overall smallest sum observed (over baseline if no decrease) using the same techniques as baseline; Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase In the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|From randomization until progression or death (up to 120 months)|||Months||95% Confidence Interval|Median
726744|NCT00357760|Other Pre-specified|Angiogenesis-related Protein Expression||Assessed every 8 weeks during treatment and end of treatment||||||
726745|NCT00357760|Other Pre-specified|Circulating Levels of VEGF-Trap Complex||Assessed at baseline, 4 weeks, 6 weeks, 8 weeks and end of treatment||||||
726746|NCT00357760|Secondary|Progression-free Survival (PFS) Among Patients Who Undergo Dose Escalation Following Progression on Lower-dose VEGF Trap|"Patients who progressed on the 1 mg/kg dose (Arm B) at 8 weeks would have the opportunity to receive the 4 mg/kg dose. PFS is defined as the time from dose escalation to disease progression or death, whichever occurs first.
Disease progression is defined using Response Evaluation Criteria In Solid Tumors (RECIST), as a 20% increase in the sum of the longest diameters of target lesions, or the appearance of new lesions, or unequivocal progression of existing nontarget lesions."|Assessed every 8 weeks while on treatment and then every 3 months until patient is 2 years from enrollment, and then every 6 months until patient is 3 years from enrollment|Only patients who progressed on the low dose (Arm B) and underwent dose escalation were included in this analysis.||weeks||90% Confidence Interval|Median
726747|NCT00357760|Secondary|Proportion of Patients With Objective Response|"Objective response is defined as complete response (CR) or partial response (PR) determined by Solid Tumor Response Criteria (RECIST).
CR: The disappearance of all target lesions without the appearance of new lesion(s) and/or unequivocal progression of existing non-target lesions.
PR: At least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter without the appearance of new lesion(s) and/or unequivocal progression of existing non-target lesions.
To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no less than four weeks after the criteria for response are first met."|Assessed every 8 weeks while on treatment and then every 3 months until patient is 2 years from enrollment, and then every 6 months until patient is 3 years from enrollment|Eligible and treated patients are included in this analysis.||proportion of participants||90% Confidence Interval|Number
726748|NCT00357760|Primary|Proportion of Patients Alive and Progression-free at 8 Weeks|"Progression-free survival (PFS) was defined as time from randomization to the earlier of documentation of progression or death. The proportion of patients who are progression-free and alive at 8 weeks was estimated using the Kaplan-Meier method and the confidence interval was estimated using log transformation method.
Progression is defined using Response Evaluation Criteria In Solid Tumors (RECIST), as a 20% increase in the sum of the longest diameters of target lesions, or the appearance of new lesions, or unequivocal progression of existing nontarget lesions."|Assessed at 8 weeks|Eligible and treated patients are included in this analysis.||proportion of participants||90% Confidence Interval|Number
726749|NCT00357877|Secondary|Cumulative Crude D12FS Caries Increment|This is computed analogous to the cumulative net D12FS increment, but ignoring reversals by assigning them weights of zero.|Visit 1, 7-month follow-up, 13-month follow-up|Intention-to-Treat sample||caries increment units/13 months||Standard Error|Mean
726750|NCT00357877|Secondary|Total Crude D12FS Caries Increment|Computed analogous to the total net D12FS caries increment, but ignoring reversals (essentially assigned them zero weight). Computed only using baseline to 13-month visit data.|V1-13-month follow-up|Intention-to-Treat sample||caries increment units/13 months||Standard Error|Mean
726752|NCT00357877|Primary|Total Net D12FS Caries Increment (Total of Non-cavitated Lesions (D1), Cavitated Lesions (D2) and Sound Surfaces (S))|"Study duration was too short to have progression from D2 (cavitated lesions) to D3 (cavitated lesions that involved dentin). D2 and D3 were treated equivalently for analysis.
This measure is computed as the sum of weighted counts of transitions in tooth surface status (root and coronal surfaces combined) from randomization to the 13-month follow-up visit. Disease progression had a positive weight (e.g., S-to-D1 (sound to non-cavitated lesion) or D1-to-D2 (non-cavitated to cavitated lesion) = 1, S-to-D2 (sound to cavitated lesion)= 2). Reversal had a negative weight (e.g., D1-to-S = −1). No change, transitions to or from missing or unscorable, and impossible transitions had 0 weight. Incident fillings and crowns were treated the same as incident D2 lesions for purposes of scoring. More details of the transition weights may be found at Vollmer WM et al. (2010). Design of the Prevention of Adult Caries Study (PACS): a randomized clinical trial assessing the effect of a"|(V1) to the 13 month follow-up visit|Intention to treat (ITT) sample. Multiple imputation with 8 datasets imputed via Markov Chain Monte Carlo sampling was used to handle missing data.||weighted increment units/13 months||Standard Error|Mean
726753|NCT00357903|Primary|Total Exposure Adjusted Rate of Serious Adverse Events|Rate of serious adverse events adjusted to total exposure to etanercept (events / exposure * 100)|Up to 10 years|All participants who received at least one dose of etanercept||Events per 100 participant-years|||Number
726754|NCT00357903|Secondary|Standardized Incidence Rate for All SEER Cancers|Standardized incidence rate for all cancers tracked by the National Cancer Institute's Surveillance Epidemiology and End Results (SEER) system.|up to 10 years|All participants who received at least one dose of etanercept||Observed count / expected count|||Number
726755|NCT00357903|Secondary|JRA DOI 30 at Month 3 in Juveniles|Juvenile Rheumatoid Arthritis Definition of Improvement 30 (JRA DOI 30), defined as a 30% improvement from baseline in 3 of 6 items (including Childhood Health Assessment Questionnaire, disease severity, overall well-being, and erythrocyte sedimentation rate) and a worsening of >30% in at most one of the remaining items.|Baseline and month 3|All participants who received at least one dose of etanercept and were evaluable for this endpoint at 3 months||Participants|||Number
726756|NCT00357903|Secondary|ACR20 at Month 3 in Adults|American College of Rheumatology (ACR) 20, defined as a 20% improvement in both tender and swollen joints (78 joints) and a 20% improvement in 3 of 5 items (including physician and patient global assessments), in adults|Baseline and month 3|All participants who received at least one dose of etanercept and had available data at both baseline and month 3||Participants|||Number
726757|NCT00357903|Secondary|C-Reactive Protein|C-reactive protein at month 12|Month 12|All participants who received at least one dose of etanercept and had available data||mg/dL||Standard Deviation|Mean
726758|NCT00357903|Secondary|Childhood Health Assessment Questionnaire|Childhood Health Assessment Questionnaire (CHAQ) disability index, having a range of 0 (no difficulty) to 3 (unable to do).|Month 12|All participants who received at least one dose of etanercept and had available data||Units on a scale||Standard Deviation|Mean
726759|NCT00357903|Secondary|Health Assessment Questionnaire Disability Index|Health Assessment Questionnaire Disability Index (HAQ DI). This index is a weighted average of 24 items, each scored 0 (no difficulty) to 3 (unable to function).|Month 12|All participants who received at least one dose of etanercept and had available data||Units on a scale||Standard Deviation|Mean
726760|NCT00357903|Secondary|Swollen Joint Count|Number of swollen joints|Month 12|All participants who received at least one dose of etanercept and had available data||Joints||Standard Deviation|Mean
726761|NCT00357903|Secondary|Tender Joint Count|Number of tender joints, as assessed by the investigator using criteria based on pressure and joint manipulation|Month 12|All participants who received at least one dose of etanercept and had available data||Joints||Standard Deviation|Mean
726762|NCT00357903|Primary|Death|Occurrence of death on study within 30 days of the last dose of etanercept|Up to 10 years|All participants who received at least one dose of etanercept||Participants|||Number
726763|NCT00357903|Primary|Serious Infectious Event|Occurrence of one or more serious infectious events within the participant on study within 30 days of the last dose of study medication. A serious infectious event is a serious adverse event that is infectious.|Up to 10 years|All participants who received at least one dose of etanercept||Participants|||Number
726764|NCT00357903|Primary|Lymphoma|Occurrence of one or more lymphomas on study within 30 days of the last dose of etanercept|Up to 10 years|All participants who received at least one dose of etanercept||Participants|||Number
726765|NCT00357903|Primary|Malignancy|Occurrence of one or more malignancies on study within 30 days of the last dose of etanercept|Up to 10 years|All participants who received at least one dose of etanercept||Participants|||Number
726766|NCT00357903|Primary|Total Exposure Adjusted Rate of Lymphomas|Rate of lymphomas occurring on study within 30 days of the last dose of etanercept, adjusted for total exposure to etanercept|Up to 10 years|All participants who received at least one dose of etanercept||Lymphomas per 100 participant-years|||Number
726767|NCT00357903|Primary|Total Exposure Adjusted Rate of Serious Infectious Events|Exposure-adjusted rate of serious infectious events (associated with hospitalization or IV antibiotics) occurring on study within 30 days of the last dose of etanercept|Up to 10 years|All participants who received at least one dose of etanercept||Events per 100 participant-years|||Number
726768|NCT00357903|Primary|Total Exposure Adjusted Rate of Deaths|Rate of deaths within 30 days of the last dose of etanercept, adjusted for total exposure to etanercept|Up to 10 years|All participants who received at least one dose of etanercept||Deaths per 100 participant-years|||Number
726769|NCT00357903|Primary|Total Exposure Adjusted Rate of Malignancies|Exposure-adjusted rate of malignancies, excluding nonmelanoma skin cancers, occurring on study within 30 days of the last dose of etanercept|Up to 10 years|All participants who received at least one dose of etanercept||Malignancies per 100 participant-years|||Number
726770|NCT00357903|Secondary|Dosing Period|Duration of etanercept dosing|Up to 10 years|All participants who received at least one dose of etanercept||Days||Standard Deviation|Mean
726771|NCT00357903|Primary|Total Exposure to Etanercept With Gaps|Total participant exposure to etanercept (Enbrel) with gaps|Up to 10 years|All participants who received at least one dose of etanercept||Participant-years|||Number
727264|NCT00362375|Other Pre-specified|Number of Male Sex Partners|The number of male sex partners during the past 3 months|Past 3 months|Based on the number of women who provided valid data at the 3-month follow-up||Number of sex partners||Standard Deviation|Mean
726774|NCT00357968|Secondary|Myonecrosis Measure: Cardiac Troponin at 6 Hours After the Loading Dose|Mean troponin level at 6 hours after the loading dose. Troponin is a biomarker for myonecrosis.|6 hours after loading dose|Includes patients who received a loading dose, underwent PCI, did not receive a GP IIb/IIIa antagonist, and had an evaluable troponin measure.||ng/ml||Standard Deviation|Mean
726775|NCT00357968|Secondary|Myonecrosis Measure: Creatine Kinase-Myocardial Bands (CK-MB) 18 to 24 Hours After the Loading Dose|Mean CK-MB at 18-24 hours after loading dose. CK-MB is a biomarker for myonecrosis.|18 to 24 hours after loading dose|Includes patients who received a loading dose, underwent PCI, did not receive a GP IIb/IIIa antagonist, and had an evaluable CK-MB measure.||IU/L||Standard Deviation|Median
726776|NCT00357968|Secondary|Myonecrosis Measure: Creatine Kinase-Myocardial Bands (CK-MB) at 6 Hours After the Loading Dose|Mean CK-MB at 6 hours after loading dose. CK-MB is a biomarker for myonecrosis|6 hours after loading dose|Includes patients who received a loading dose, underwent PCI, did not receive a GP IIb/IIIa antagonist, and had an evaluable CK-MB measure.||IU/L||Standard Deviation|Mean
726777|NCT00357968|Secondary|Platelet Reactivity Index Percent (PRI%) Measured by Vasodilator-stimulated Phosphoprotein (VASP) After 14 Days of Maintenance Dose Treatment|VASP phosphorylation in response to prostaglandin E1 (PGE1) with and without ADP was determined by whole-blood flow cytometry and was expressed as a platelet reactivity index (PRI). PRI was defined as [(MFI(with PGE1) - MFI (with PGE1 and ADP))/MFI(with PGE1) x 100] where MFI is mean fluorescence index. A lower PRI indicates greater antiplatelet effect.|after 14 days of maintenance dosing|Includes patients who received a loading dose and PCI, regardless of GP IIb/IIIa antagonist use (this includes subjects who received prasugrel and clopidogrel, in either order, during crossover)||percent (%) platelet reactivity index||Standard Deviation|Mean
726778|NCT00357968|Secondary|Platelet Reactivity Index Percent (PRI%) Measured by Vasodilator-stimulated Phosphoprotein (VASP) 18 to 24 Hours After the Loading Dose|VASP phosphorylation in response to prostaglandin E1 (PGE1) with and without ADP was determined by whole-blood flow cytometry and was expressed as a platelet reactivity index (PRI). PRI was defined as [(MFI(with PGE1) - MFI (with PGE1 and ADP))/MFI(with PGE1) x 100] where MFI is mean flourescence index. A lower PRI indicates greater antiplatelet effect.|18 to 24 hours after loading dose|Includes patients who received a loading dose, underwent PCI, did not receive a GP IIb/IIIa antagonist, and had evaluable VASP measurements.||percent (%) platelet reactivity index||Standard Deviation|Mean
726779|NCT00357968|Secondary|Platelet Reactivity Index Percent (PRI%) Measured by Vasodilator-stimulated Phosphoprotein (VASP) at 6 Hours After the Loading Dose|VASP phosphorylation in response to prostaglandin E1 (PGE1) with and without ADP was determined by whole-blood flow cytometry and was expressed as a platelet reactivity index (PRI). PRI was defined as [(MFI(with PGE1) - MFI (with PGE1 and ADP))/MFI(with PGE1) x 100] where MFI is mean fluorescence index. A lower PRI indicates greater antiplatelet effect.|6 hours after loading dose|Includes patients who received a loading dose, underwent PCI, and had evaluable VASP measurements, and did not receive a GP IIb/IIIa antagonist. Patients had received a single loading dose but had not yet received any maintenance treatment.||percent (%) platelet reactivity index||Standard Deviation|Mean
726780|NCT00357968|Secondary|Platelet Reactivity Index Percent (PRI%) Measured by Vasodilator-stimulated Phosphoprotein (VASP) at 2 Hours After the Loading Dose|VASP phosphorylation in response to prostaglandin E1 (PGE1) with and without ADP was determined by whole-blood flow cytometry and was expressed as a platelet reactivity index (PRI). PRI was defined as [(MFI(with PGE1) - MFI (with PGE1 and ADP))/MFI(with PGE1) x 100] where MFI is mean fluorescence index. A lower PRI indicates greater antiplatelet effect.|2 hours after loading dose|Includes patients who received a loading dose, underwent PCI, did not receive a GP IIb/IIIa antagonist, and had evaluable VASP measurements. Patients had received a single loading dose but had not yet received any maintenance treatment.||percent (%) platelet reactivity index||Standard Deviation|Mean
726781|NCT00357968|Secondary|Number of Hyporesponsive Participants at the End of the Crossover Maintenance Dose Phase|Number of patients with inhibition of platelet aggregation (IPA) with 20 uM adenosine diphosphate (ADP) <20%|14 days after cross-over|Includes patients who received a single loading dose and had evaluable MPA measures,regardless of glycoprotein (GP) IIb/IIIa antagonist use. Patients received 14 days of maintenance treatment and then crossed-over to the alternate maintenance treatment for 14 days.||participants|||Number
726782|NCT00357968|Secondary|Number of Hyporesponsive Participants at the End of the First Maintenance Dose Phase|Number of patients with inhibition of platelet aggregation (IPA) with 20 uM adenosine diphosphate (ADP) <20%|From loading dose to day 15|Includes patients who received a single loading dose and had evaluable MPA measures, regardless of glycoprotein (GP) IIb/IIIa antagonist use. Patients had received 14 days of maintenance treatment but had not crossed-over to the alternate maintenance treatment.||participants|||Number
726783|NCT00357968|Secondary|Number of Hyporesponsive Participants at 6 Hours After the Loading Dose|Number of patients with inhibition of platelet aggregation (IPA) with 20 uM adenosine diphosphate (ADP) <20%|6 hours after loading dose|"Includes patients who received a loading dose of the study drug, did not receive a glycoprotein (GP) IIb/IIIa antagonist and had evaluable pre-treatment, and 6 hour MPA measurements.
Patients had received a single loading dose of either 60-mg prasugrel or 600-mg clopidogrel but had not yet received any maintenance dosing."||participants|||Number
726784|NCT00357968|Secondary|Number of Participants With Major Adverse Cardiac Events During the Crossover Maintenance Dose Phase|Number of patients who met any of the following endpoints: cardiovascular death, myocardial infarction, stroke, subacute stent thrombosis, or urgent target vessel revascularization|14 days after cross-over|Includes all patients who received a loading dose and underwent PCI, received a maintenance dose for 14 days, and then crossed-over to the alternate therapy for an additional 14 days of maintenance dosing.||participants|||Number
726785|NCT00357968|Secondary|Number of Participants With Major Adverse Cardiac Events (MACE) During the First Maintenance Dose Phase|Number of patients who met any of the following endpoints: cardiovascular death, myocardial infarction, stroke, subacute stent thrombosis, or urgent target vessel revascularization|after 14 days of treatment (before cross-over)|Includes all patients who received a loading dose. Patients who underwent PCI also received 14 days of maintenance treatment. Patients had not yet crossed-over to the alternate maintenance treatment.||participants|||Number
727265|NCT00362375|Other Pre-specified|Unprotected Vaginal Sex With Any Male Partner|The percentage of women who engaged in unprotected vaginal sex (i.e., did not use a condom) with any male partner during the past 3 months|Past 3 months|Based on the number of women who provided valid data at the 3-month follow-up||Percent|||Number
726786|NCT00357968|Secondary|Number of Participants With Non-Coronary Artery Bypass Graft (CABG) Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding During the Crossover Maintenance Dose Phase|"Non-CABG-related TIMI major bleeding was any intracranial hemorrhage OR any clinically overt bleeding associated with a fall in hemoglobin >=5 gm/dL.
Non-CABG-related TIMI minor bleeding was any clinically overt bleeding associated with a fall in hemoglobin >=3 gm/dL but <5 gm/dL."|14 days after cross-over|All patients who received a loading dose of study drug, received maintenance therapy for 14 days and then switched to the alternate maintenance therapy.||participants|||Number
726787|NCT00357968|Secondary|Number of Participants With Non-Coronary Artery Bypass Graft (CABG) Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding During the First Maintenance Dose Phase|"Non-CABG-related TIMI major bleeding was any intracranial hemorrhage OR any clinically overt bleeding associated with a fall in hemoglobin >=5 gm/dL.
Non-CABG-related TIMI minor bleeding was any clinically overt bleeding associated with a fall in hemoglobin >=3 gm/dL but <5 gm/dL."|after 14 days of treatment (before cross-over)|Patients received a single loading dose and 14 days of maintenance therapy. Patients had not yet crossed-over to the alternate maintenance dose.||participants|||Number
726788|NCT00357968|Secondary|Inhibition of Platelet Aggregation to 20 μM Adenosine Diphosphate at 2 Hours After the Loading Dose|IPA was defined as (1 - [maximal platelet aggregation (MPA) at 2 hours after study drug treatment]/[MPA before drug treatment]) x 100.|2 hours after loading dose|Includes all patients who received a loading dose of study drug, did not receive a GP IIb/IIIa antagonist and had evaluable pretreatment and 2 hour MPA measurements. Patients had received a single loading dose of either 60-mg prasugrel or 600-mg clopidogrel but had not yet received any maintenance dosing.||percent inhibition||Standard Deviation|Mean
726789|NCT00357968|Primary|Inhibition of Platelet Aggregation to 20 μM Adenosine Diphosphate After 14 Days of Maintenance Dose Treatment|"Measures IPA during maintenance dosing before and after cross-over for each therapy.
IPA was defined as (1 - [maximal platelet aggregation(MPA) at 14 days after study drug treatment]/[MPA before drug treatment]) x 100."|after 14 days of maintenance dosing|Includes patients who received a loading dose and underwent percutaneous coronary intervention (PCI) regardless of GP IIb/IIIa antagonist use (this includes subjects who received prasugrel and clopidogrel, in either order, during crossover)||percent inhibition||Standard Deviation|Mean
726790|NCT00357968|Primary|Inhibition of Platelet Aggregation (IPA) to 20 Micromolar (μM) Adenosine Diphosphate (ADP) at 6 Hours After the Loading Dose|IPA was defined as (1 - [maximal platelet aggregation(MPA) at 6 hours after study drug treatment]/[MPA before drug treatment]) x 100.|6 hours after loading dose|"Consists of all patients who received a loading dose of the study drug, did not receive a glycoprotein (GP) IIb/IIIa antagonist, and had evaluable pre-treatment and 6 hour MPA measurements.
Patients had received a single loading dose of either 60-mg prasugrel or 600-mg clopidogrel but had not yet received any maintenance dosing."||percent inhibition||Standard Deviation|Mean
726791|NCT00357994|Secondary|Employment Impairment (EMP) II Status at Week 12|The EMP instruments are designed to collect information regarding employment and ability to run a household. EMP I questions include: Are you currently in paid employment? (If yes, at which percentage have you been working during the last 4 weeks?); Have you got someone to run your household for you? (If yes, how much time per week does he/she spend in your household?); Are you retired? (If yes, for which reason?) The retirement question (from EMP I) is excluded from the EMP II instrument.|Week 12 (or early termination)|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment. Missing data was not imputed.||participants|||Number
726792|NCT00357994|Secondary|Employment Impairment (EMP) I Status at Baseline|The EMP instruments are designed to collect information regarding employment and ability to run a household. EMP I questions include: Are you currently in paid employment? (If yes, at which percentage have you been working during the last 4 weeks?); Have you got someone to run your household for you? (If yes, how much time per week does he/she spend in your household?); Are you retired? (If yes, for which reason?).|Baseline|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment. Missing data was not imputed.||participants|||Number
726793|NCT00357994|Secondary|Change From Baseline in EuroQol Quality of Life Scale (EQ-5D) Visual Analogue Scale (VAS) at Week 12|The EQ-5D VAS records the participant's self-rated health on a scale from 0–100 where 100 is the 'best imaginable health state' and 0 is the 'worst imaginable health state.'|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
726794|NCT00357994|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Week 12|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The total score is the sum of the responses to the 31 questions (44 answers) that comprise Parts I-III of the scale. The total score will range from 0-176, with 176 representing the worst (total) disability, and 0 no disability.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
726795|NCT00357994|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Questions 32, 33, and 34 at Week 12|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. Questions 32, 33, and 34 on UPDRS Part IV were totaled to evaluate dyskinesias. Each of these questions is measured on a 5-point scale (0-4). The Part IV dyskinesia score will range from 0-12 and higher scores are associated with more disability.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment. No missing data was imputed.||units on a scale||Standard Error|Least Squares Mean
726796|NCT00357994|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score at Week 12|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part IV Score is the sum of the answers to the 11 questions that comprise Part IV, each of which are measured on a 5-point scale (0–4) or a 2-point scale (0 or 1). The Part IV score ranges from 0–23 and higher scores are associated with more disability.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
726797|NCT00357994|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score at Week 12|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part I Score is the sum of the answers to the 4 questions that comprise Part I, each of which are measured on a 5-point scale (0-4). The Part I score ranges from 0-16 and higher scores are associated with more disability.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment. No missing data was imputed.||units on a scale||Standard Error|Least Squares Mean
726798|NCT00357994|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Bodily Discomfort Domain Score at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson’s disease patients. The PDQ-39 Domain: Bodily Discomfort includes 3 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
726799|NCT00357994|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Communication Domain Score at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson’s disease patients. The PDQ-39 Domain: Communication includes 3 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
726800|NCT00357994|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Cognition Domain Score at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson’s disease patients. The PDQ-39 Domain: Cognition includes 4 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
726801|NCT00357994|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Social Support Domain Score at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson’s disease patients. The PDQ-39 Domain: Social Support includes 3 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
726802|NCT00357994|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Stigma Domain Score at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson’s disease patients. The PDQ-39 Domain: Stigma (e.g., social embarrassment) consists of 4 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
726803|NCT00357994|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Emotional Well-Being Domain Score at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson’s disease patients. The PDQ-39 Domain: Emotional Well-being (e.g., feelings of isolation) includes 6 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
726822|NCT00358150|Secondary|Number of Participants With Bone Pain Levels During the Past 4 Weeks at Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study|Bone pain was assessed as a part of Gaucher disease assessment in participants. Participants were categorized as none (no bone pain), very mild bone pain, mild bone pain and moderate bone pain. In this outcome, number of participants with different levels of bone pain at specified time points were reported.|Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study (Up to Year 9)|Full analysis set consists of all participants who signed informed consent and received at least one dose of eliglustat. Here ‘n’ signifies number of participants with available data at specified time points.||participants|||Number
726804|NCT00357994|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Activities of Daily Living Domain Score at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson’s disease patients. The PDQ-39 Domain: Activities of Daily Living (e.g., difficulty cutting food) includes 6 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
726805|NCT00357994|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Mobility Domain Score at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson’s disease patients. The PDQ-39 Domain: Mobility (e.g., fear of falling when walking) includes 10 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
726806|NCT00357994|Secondary|"Change From Baseline in Average Daily Normalized On Time With Troublesome Dyskinesia at Week 12"|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis."|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
726807|NCT00357994|Secondary|Change From Baseline in Zarit Burden Interview (ZBI) Total Score at Week 12|The ZBI is a 22-item questionnaire regarding the caregiver/subject relationship and evaluates the caregiver's health condition, psychological well-being, finances and social life. Each question is answered on a 5-point scale (0=Never, 1=Rarely, 2=Sometimes, 3=Quite frequently, and 4= Nearly always). The caregiver burden is evaluated by the total score (Range 0 to 88) obtained from the sum of the answers to the 22 questions. Higher scores are associated with a higher level of burden for the caregiver.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
726808|NCT00357994|Secondary|Change From Baseline in EuroQual Quality of Life - 5 Dimensions (EQ-5D) Summary Index at Week 12|The EQ-5D is a participant answered questionnaire scoring 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that essentially attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 to 1.00 with positive change indicating improvement.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
726809|NCT00357994|Secondary|Change From Baseline in UPDRS Part III Score at Week 12|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part III score is the sum of the 27 answers provided to the 14 Part III questions, each of which are measured on a 5-point scale (0-4). The Part III score ranges from 0-108 and higher scores are associated with more disability.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
726810|NCT00357994|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at Week 12|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part II score is the sum of the answers to the 13 questions that comprise Part II, each of which are measured on a 5-point scale (0-4). The Part II score ranges from 0-52 and higher scores are associated with more disability.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
726811|NCT00357994|Secondary|Clinical Global Impression - Status (CGI-S) Score at Baseline and Clinical Global Impression - Improvement (CGI-I) Score at Week 12|The CGI-S is a global assessment by the Investigator of current symptomatology and impact of illness on functioning. The ratings of the CGI-S are as follows: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, and 7 = among the most extremely ill. The CGI-I is a global assessment by the Investigator of the change in clinical status since the start of treatment. The CGI-I ratings are as follows: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Deviation|Mean
726812|NCT00357994|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson’s disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The PDQ-39 Summary Index is the sum of all answers divided by the highest score possible (i.e. number of answers multiplied by 4) which is multiplied by 100 to put the score on a 0-100 scale. Higher scores are associated with more severe symptoms.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
726813|NCT00357994|Secondary|"Change From Baseline in Average Daily Normalized On Time Without Troublesome Dyskinesia at Week 12"|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. On time without troublesome dyskinesia (involuntary muscle movement) is defined as on time without dyskinesia and on time with non-troublesome dyskinesia. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Positive change from Baseline for on time without troublesome dyskinesia indicates improvement."|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||hours||Standard Error|Least Squares Mean
726814|NCT00357994|Primary|"Change From Baseline to Week 12 in Average Daily Normalized Off Time"|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Negative change from baseline for off time indicates improvement."|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||hours||Standard Error|Least Squares Mean
726815|NCT00358007|Primary|Average Residual Error Motion of Patients Undergoing Radiotherapy|To determine the magnitude of random variance (random error) in radiotherapy treatment of head and neck neoplasms|Daily after each radiotherapy treatment|||millimeters||Standard Deviation|Mean
726816|NCT00358007|Primary|Average Interfraction Shift of Patients Undergoing Radiotherapy|"Determine the magnitude of the systematic error of patient positioning as determined by cone beam CT (CBCT) and the desired placement based on the treatment planning CT scan.
Every day, prior to radiation treatment, a CBCT will be performed. The CBCT images will be compared to the radiation therapy planning CT image just taken."|Daily prior to radiation|||millimeters||Standard Deviation|Mean
726817|NCT00358150|Secondary|Lumbar Spine and Femur Z-Scores for BMD at Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study|Images of the lumbar spine and femur were obtained by DXA to determine Z-score for each bone area and total bone mineral density. The Z-score bone density categories are: normal (score >-2) and below normal (score <=-2).|Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study (up to Year 9)|Full analysis set consists of all participants who signed informed consent and received at least one dose of eliglustat. Here ‘n’ signifies number of participants with available data at specified time points.||Z-Score||Standard Deviation|Mean
726818|NCT00358150|Secondary|Lumbar Spine and Femur T-Scores for Bone Mineral Density (BMD) at Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study|Images of the lumbar spine and femur were obtained by dual energy X-ray absorptiometry (DXA) to determine T-score for each bone area and total bone mineral density. T-scores compares participant's bone density with that of healthy young participant of same gender. The T-score bone density categories were: normal (score >-1), osteopenia (score -2.5 to <=-1), and osteoporosis (score <= -2.5).|Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study (up to Year 9)|Full analysis set consists of all participants who signed informed consent and received at least one dose of eliglustat. Here ‘n’ signifies number of participants with available data at specified time points.||T-Score||Standard Deviation|Mean
726819|NCT00358150|Secondary|Bone Marrow Infiltration: Number of Participants With Improvement From Baseline in Dark Marrow at Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8 and at End of Study (EOS)|Bone marrow infiltration assessments were designed to evaluate improvements in dark marrow using MRI. Each MRI assessment was performed for both femurs and consisted of reviewing 6 different zones (the femoral head, greater trochanter, intertrochanteric region, shaft, distal metaphysis, and condyles). MRI images recorded dark marrow for each zone as either present or not present at baseline. In this outcome, number of participants (for whom dark marrow was present at baseline) with improvement from baseline in dark marrow at each specified time point were reported.|Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8 and at End of Study (up to Year 9)|Full analysis set consists of all participants who signed informed consent and received at least one dose of eliglustat. Here ’n’ signifies number of participants who were presented with dark marrow at baseline and had data available at specified time points.||Participants|||Count of Participants
726820|NCT00358150|Secondary|Number of Participants With No Bone Crisis at Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study|Bone crisis was assessed as a part of Gaucher disease assessment in participants. Acute, excruciating episodic bone pain is characteristic of Gaucher bone crisis, which typically causes debilitation lasting several days or longer and requires treatment with immobilization, hydration, and opioid analgesics. Participants were categorized as 0= no bone crisis, 1= 1 bone crisis, and 2= 2 bone crises during the assessment period. In this outcome, number of participants with 0= no bone crises levels at specified time points were reported.|Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study (Up to Year 9)|Full analysis set consists of all participants who signed informed consent and received at least one dose of eliglustat. Here ‘n’ signifies number of participants with available data at specified time points.||participants|||Number
726821|NCT00358150|Secondary|Number of Participants With Mobility Status (MS) at Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study|Mobillity, i.e. ability to walk was assessed as a part of Gaucher disease assessment in participants.In this outcome, number of participants with their different mobility status (unrestricted mobility, walks with difficulty) at specified time points were reported.|Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study (Up to Year 9)|Full analysis set consists of all participants who signed informed consent and received at least one dose of eliglustat. Here ‘n’ signifies number of participants with available data at specified time points.||participants|||Number
727872|NCT00370682|Secondary|Incidence of Suspected and Confirmed Dengue Throughout the Entire Study Period.|Number of subjects with incidence of suspected and confirmed dengue throughout the entire study period.|9 months|||Participants|||Count of Participants
726823|NCT00358150|Secondary|Change From Baseline in Fatigue Severity Scale (FSS) Scores at Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study|The FSS is an instrument consisting of 9 self-administered questions that measures the impact of severity of fatigue symptoms on everyday functioning, based on the recall over the past week. Score range for each question ranges from 1 (minimum) to 7 (maximum), where higher score indicates greater severity. FSS total score was calculated by averaging the results of all questions. Total FSS score ranges from 9 (minimum) to 63 (maximum), where higher scores indicates greater severity.|Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study (Up to Year 9)|Full analysis set consists of all participants who signed informed consent and received at least one dose of eliglustat. Here 'n' signifies number of participants with available data at specified time points.||units on a scale||Standard Deviation|Mean
726824|NCT00358150|Secondary|Change From Baseline in 36-Item Short Form (SF-36) Health Survey Scores at Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8 and Year 9 at End of Study|The SF-36 questionnaire, version 2, investigates the participant’s health-related quality of life (HRQL). It is a 36-item questionnaire measuring 8 domains (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Each domain score ranges from 0 (worst) to 100 (best), with higher scores reflecting best health-related quality of life. Two summary scale scores were computed from the 8 domain scores: the Physical Component Summary and the Mental Component Summary. Score range for both summary scale ranges from 0 (worst) to 100 (best), with higher scores reflecting best health-related quality of life.|Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study (Up to Year 9)|Full analysis set consists of all participants who signed informed consent and received at least one dose of eliglustat. Here 'n' signifies number of participants with available data at specified time points.||units on a scale||Standard Deviation|Mean
726825|NCT00358150|Secondary|Percent Change From Baseline in Biomarker (Chitotriosidase) Level at Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study||Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study (Up to Year 9)|Full analysis set consists of all participants who signed informed consent and received at least one dose of eliglustat. Here ‘n’ signifies number of participants with available data at specified time points.||percent change||Standard Deviation|Mean
726826|NCT00358150|Secondary|Percent Change From Baseline in Biomarker Chemokine Ligand 18 (CCL18) Level at Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and End of Study||Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and End of Study (Up to Year 9)|Full analysis set consists of all participants who signed informed consent and received at least one dose of eliglustat. Here ‘n’ signifies number of participants with available data at specified time points.||percent change||Standard Deviation|Mean
726827|NCT00358150|Secondary|Percent Change From Baseline in Biomarker (Tartrate-Resistant Acid Phosphatase [TRAP]) Level at Year 1 and Year 2||Baseline, Year 1, Year 2|Full analysis set consists of all participants who signed informed consent and received at least one dose of eliglustat. Here ‘n’ signifies number of participants with available data at specified time points. As per the change in planned analysis, TRAP was not assessed after Year 2.||percent change||Standard Deviation|Mean
726828|NCT00358150|Secondary|Percent Change From Baseline in Biomarker (Angiotensin Converting Enzyme) Level at Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study||Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and End of Study (Up to Year 9)|Full analysis set consists of all participants who signed informed consent and received at least one dose of eliglustat. Here ‘n’ signifies number of participants with available data at specified time point.||percent change||Standard Deviation|Mean
726829|NCT00358150|Secondary|Percent Change From Baseline in Platelet Count at Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study|Percent change in platelet count = ([platelet count at specified time points minus platelet count at baseline] divided by [platelet count at baseline]) multiplied by 100.|Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study (Up to Year 9)|Full analysis set consists of all participants who signed informed consent and received at least one dose of eliglustat. Here 'n' signifies number of participants with available data at specified time points.||percent change||Standard Deviation|Mean
726830|NCT00358150|Secondary|Absolute Change From Baseline in Hemoglobin at Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study|Absolute change = hemoglobin level at specified time points minus hemoglobin level at baseline.|Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study (Up to Year 9)|Full analysis set consists of all participants who signed informed consent and received at least one dose of eliglustat. Here ‘n’ signifies number of participants with available data at specified time points.||g/dL||Standard Deviation|Mean
726831|NCT00358150|Secondary|Percent Change From Baseline in Liver Volume at Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study|Percent change in liver volume = ([liver volume at specified time points minus liver volume at baseline] divided by [liver volume at baseline]) multiplied by 100, where all volumes are in multiples of normal.|Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study (Up to Year 9)|Full analysis set consists of all participants who signed informed consent and received at least one dose of eliglustat. Here ‘n’ signifies number of participants with available data at specified time points.||percent change||Standard Deviation|Mean
726832|NCT00358150|Secondary|Percent Change From Baseline in Spleen Volume at Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study|Percent change in spleen volume = ([spleen volume at specified time points minus spleen volume at baseline] divided by [spleen volume at baseline]) multiplied by 100, where all volumes are in multiples of normal.|Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study (Up to Year 9)|Full analysis set consists of all participants who signed informed consent and received at least one dose of eliglustat. Here 'n' signifies number of participants with available data at specified time points.||percent change||Standard Deviation|Mean
726898|NCT00358579|Secondary|Return of Spontaneous Circulation.|Return of spontaneous circulation is defined as the presence of any palpable pulse detected by manual palpation of a major artery. This is measured as number of participants who had return of spontaneous circulation during resuscitation.|during resuscitation|||Participants|||Number
726833|NCT00358150|Primary|Percentage of Participants Demonstrating A Meaningful Clinical Response|A meaningful clinical response was defined as an improvement in at least 2 of the 3 main efficacy parameters: a) an increase in hemoglobin of greater than or equal to (>=) 0.5 gram/deciliter from baseline, b) an increase in platelets of >=15 percent (%) from baseline, c) reduction in total spleen volume of >= 15% from baseline. As hemoglobin, platelets, total spleen volume were abnormal at baseline, within each participant, only those parameters were used in the evaluation of meaningful clinical response which were abnormal at baseline.|Baseline, Year 1|Full analysis set consists of all participants who signed informed consent and received at least one dose of eliglustat.||percentage of participants|||Number
726834|NCT00358215|Secondary|Change From Baseline to Month 6 in KCCQ Symptom Frequency Score|The KCCQ is a disease-specific patient-reported outcomes measure for patients with heart failure. It consists of 23 items, is comprised of 7 clinically relevant scales (Symptom Frequency, Symptom Burden, Symptom Stability, Physical Limitation, Social Limitation, Quality of Life, and Self-Efficacy), and yields 3 summary scores (Clinical Summary, Total Symptom, and Overall Summary Scores). Scale and summary scores range between 0 and 100, with higher scores indicating better health status (eg, better functioning, fewer symptoms, better quality of life). Least squares means were calculated from a mixed effects model estimating treatment effect adjusted for region, type of device, and Baseline KCCQ score.|Baseline and Month 6|Intent-to-treat participants with non-missing change from Baseline to Month 6 in KCCQ score.||units on a scale||Standard Error|Least Squares Mean
726835|NCT00358215|Secondary|Change From Baseline to Month 6 in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score|The KCCQ is a disease-specific patient-reported outcomes measure for patients with heart failure. It consists of 23 items, is comprised of 7 clinically relevant scales (Symptom Frequency, Symptom Burden, Symptom Stability, Physical Limitation, Social Limitation, Quality of Life, and Self-Efficacy), and yields 3 summary scores (Clinical Summary, Total Symptom, and Overall Summary Scores). Scale and summary scores range between 0 and 100, with higher scores indicating better health status (eg, better functioning, fewer symptoms, better quality of life). Least squares means were calculated from a mixed effects model estimating treatment effect adjusted for region, type of device, and Baseline KCCQ score.|Baseline and Month 6|Intent-to-treat participants with non-missing change from Baseline to Month 6 in KCCQ score.||units on a scale||Standard Error|Least Squares Mean
726836|NCT00358215|Secondary|Time to Cardiovascular Death or First Hospital Admission for Worsening Heart Failure|Time to cardiovascular death or first hospital admission for worsening heart failure, whichever occured first, estimated using the Kaplan Meier method. Participants not experiencing a qualifying event during the study were censored at their last contact time or the study termination date, whichever occurred first.|From randomization to the end of study; maximum time on study was 73 months|Intent-to-treat||days||Inter-Quartile Range|Median
726837|NCT00358215|Secondary|Time to Death From Any Cause|Time from randomization to death due to any cause, estimated by the Kaplan-Meier method. Participants not experiencing a qualifying event during the study were censored at their last contact time or the study termination date, whichever occurred first.|From randomization to the end of study; maximum time on study was 73 months|Intent-to-treat||days||Inter-Quartile Range|Median
726838|NCT00358215|Primary|Time to All Cause Death or First Hospitalization for Worsening Heart Failure|Time to death from any cause or first hospital admission for worsening heart failure (adjudicated by the Clinical Endpoint Committee), whichever occurred first, estimated by Kaplan-Meier method. Participants not experiencing a qualifying event during the study were censored at their last contact time or the study termination date, whichever occurred first.|From randomization to the end of study; maximum time on study was 73 months|Intent-to-treat (ITT) analysis set, defined as all randomized participants||days||Inter-Quartile Range|Median
726839|NCT00358332|Secondary|Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 364|This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA.|Day 364 +/- 14 days|Participants included are those meeting all eligibility criteria, and who have received at least one immunization with any of the study or control vaccines and for whom immunogenicity data at the indicated time point is available.||log anti-FMP2.1 titer||95% Confidence Interval|Mean
726840|NCT00358332|Secondary|Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 272.|This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA.|Day 272 +/- 14 days|Participants included are those meeting all eligibility criteria, and who have received at least one immunization with any of the study or control vaccines and for whom immunogenicity data at the indicated time point are available.||log anti-FMP2.1 titer||95% Confidence Interval|Mean
726841|NCT00358332|Secondary|Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 180|This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA.|Day 180 +/- 14 days|Participants included are those meeting all eligibility criteria, and who have received at least one immunization with any of the study or control vaccines and for whom immunogenicity data at the indicated time point are available.||log anti-FMP2.1 titer||95% Confidence Interval|Mean
726842|NCT00358332|Secondary|Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 90|This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA.|Day 90 +/- 10 days|Participants included are those meeting all eligibility criteria, and who have received at least one immunization with any of the study or control vaccines and for whom immunogenicity data at the indicated time point are available.||log anti-FMP2.1 titer||95% Confidence Interval|Mean
726843|NCT00358332|Secondary|Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 60|This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA.|Day 60 +/- 7 days|Participants included are those meeting all eligibility criteria, and who have received at least one immunization with any of the study or control vaccines and for whom immunogenicity data at the indicated time point are available.||log anti-FMP2.1 titer||95% Confidence Interval|Mean
726844|NCT00358332|Secondary|Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 30|This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA.|Day 30 +/- 7 days|Participants included are those meeting all eligibility criteria, and who have received at least one immunization with any of the study or control vaccines and for whom immunogenicity data at the indicated time point are available.||log anti-FMP2.1 titer||95% Confidence Interval|Mean
726845|NCT00358332|Primary|Occurrence of Solicited Local Symptoms During a 7-day Surveillance Period (Systematically Collected) Following Vaccinations at Days 0, 30, and 60.|The number of participants reporting pain, swelling and erythema. Participants are counted only once but may have experienced symptoms on multiple occasions.|7 Days following any vaccination|This outcome includes all enrolled subjects.||Participants|||Number
726846|NCT00358332|Secondary|Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 0|This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA.|Day 0|Participants included are those meeting all eligibility criteria, and who have received at least one immunization with any of the study or control vaccines and for whom immunogenicity data at the indicated time point are available.||log anti-FMP2.1 titer||95% Confidence Interval|Mean
726847|NCT00358332|Primary|Number of Subjects Spontaneously Reporting Any Serious Adverse Event.|Any untoward medical occurrence that resulted in death, persistent/significant disability/incapacity, required in-patient hospitalization or prolongation thereof, was life threatening or a congenital anomaly/birth defect in offspring of a study subject; or may have jeopardized the participant or required intervention to prevent one of the outcomes.|1 year after the last vaccination.|This outcome includes all enrolled subjects.||Participants|||Number
726848|NCT00358332|Primary|Occurrence of Unsolicited Symptoms During a 30-day Surveillance Period Following Vaccinations at Days 0, 30, and 60.|The number of participants spontaneously reporting any symptom (defined as any Adverse Event considered associated with the product) within 30 days of any vaccination. Participants are counted only once but may have experienced events on multiple occasions.|Day of vaccination and 30 subsequent days.|This outcome includes all enrolled subjects.||Participants|||Number
726849|NCT00358332|Primary|Occurrence of Solicited Systemic Symptoms During a 7-day Surveillance Period (Systematically Collected) Following Vaccinations at Days 0, 30, and 60.|The number of participants reporting drowsiness irritability/fussiness, loss of appetite, vomiting, and feverishness. Participants are counted only once but may have experienced symptoms on multiple occasions.|7 Days following any vaccination|This outcome includes all enrolled subjects.||Participants|||Number
726850|NCT00358436|Primary|Trough FEV1 (L) at 12 Weeks on Treatment|Trough FEV1 (mean FEV1 value of the two highest FEV1 readings measured at 23 and 24 hours after inhalation) at 12 weeks|12 weeks|Intention-to-Treat (ITT) population: all randomised patients who took at least one dose of Investigational Medicinal Product and had at least the baseline and one post-baseline value available for the primary efficacy variable.||Liters||Standard Error|Least Squares Mean
726851|NCT00358436|Secondary|Percentage of Patients Who Achieved at Least a 4-unit Decrease From Baseline in the SGRQ Total Score at 52 Weeks on Treatment|Percentage of patients who achieved a clinically relevant improvement in health-related quality of life at 52 weeks, as measured by at least a 4-unit decrease from baseline in St George's Respiratory Questionnaire (SGRQ) total score|52 weeks|Intention-to-Treat (ITT) population: all randomised patients who took at least one dose of Investigational Medicinal Product and had at least the baseline and one post-baseline value available for the primary efficacy variable.||Percentage of Patients|||Number
726852|NCT00358436|Secondary|Time to First Moderate or Severe COPD Exacerbation at 52 Weeks on Treatment|Time to first moderate or severe exacerbation: Increase of COPD symptoms during at least 2 consecutive days, treated with antibiotics and/or systemic corticosteroids or an increase in dose of systemic corticosteroids, or leading to hospitalisation.|52 weeks|Intention-to-Treat (ITT) population: all randomised patients who took at least one dose of Investigational Medicinal Product and had at least the baseline and one post-baseline value available for the primary efficacy variable.||Days||95% Confidence Interval|Median
726853|NCT00358436|Primary|Trough FEV1 (L) at 28 Weeks on Treatment|Trough FEV1 (mean FEV1 value of the two highest FEV1 readings measured at 23 and 24 hours after inhalation) at 28 weeks|28 weeks|Intention-to-Treat (ITT) population: all randomised patients who took at least one dose of Investigational Medicinal Product and had at least the baseline and one post-baseline value available for the primary efficacy variable.||Liters||Standard Error|Least Squares Mean
726854|NCT00358449|Secondary|Plasma Concentration of Mepolizumab|Blood samples were obtained at pre-infusion and 5m, 2h, 24h, 72-96h post-infusion at Day 1, Weeks 4, 8; and Weeks 2, 6 10, 12, 16, 20, 24 and 34 to estimate the plasma concentration of mepolizumab. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).|Day 1, Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24 and 34|Pharmacokinetic Population: all participants who received study medication and for whom mepolizumab sample was obtained and analyzed.||Microgram per milliliter (µg/mL)||Standard Deviation|Mean
726855|NCT00358449|Secondary|Absolute Blood Eosinophils Count at the Indicated Time Points|Blood samples were obtained at Screening, pre-infusion and 24h and 72-96h post-infusion at Day 1, Weeks 4 and 8; and at Week 2, 6, 10, 12, 16, 20, 24 and 34 visits or Early Withdrawal Visit to estimate blood eosinophil count.|Screening, Day 1, Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24 and 34|ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).||Giga cells per liter (GI/L)||Standard Deviation|Mean
726856|NCT00358449|Secondary|Change From Baseline in Mean Esophageal Eosinophil Counts at Weeks 12 and 24|Participants underwent an EGD with biopsies at Screening and at Weeks 12 and 24. Mean esophageal eosinophils were calculated as the mean number across all esophageal biopsies at each time point. Screening value was considered as the Baseline value. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline, Weeks 12 and 24|ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).||Cells/HPF||Standard Error|Mean
726857|NCT00358449|Secondary|Mean Change From Baseline in Peak Esophageal Eosinophil Counts at Weeks 12 and 24|Participants underwent an esophagogastroduodenoscopy (EGD) with biopsies at Screening and at Weeks 12 and 24. Peak esophageal eosinophils were calculated as the maximum count across all esophageal biopsies at each time point. Screening value was considered as the Baseline value. Change from baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline, Weeks 12 and 24|ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).||Cells/HPF||Standard Error|Mean
726899|NCT00358579|Secondary|Neurological Status at 1 Year.|Neurological status is assessed by the Glasgow-Pittsburgh outcome categories, to evaluate quality of life after successful resuscitation. Good neurological status is defined as cerebral performance categories(CPC)/overall performance categories(OPC): 1 and 2. CPC/OPC 1 indicates good cerebral & overall performance. CPC/OPC 2 indicates moderate cerebral & overall disability. CPC/OPC 3 indicates severe cerebral & overall disability. CPC/OPC 4 indicates coma, vegetative state. CPC/OPC 5 indicates brain dead/death.|at 1 year post arrest|||Participants|||Number
727266|NCT00362375|Other Pre-specified|Sexual Abstinence|The percentage of women who did not engage in vaginal, oral or anal sexual intercourse with male partners|Past 3 months|Based on the number of women who provided valid data at the 3-month follow-up||Percent|||Number
726858|NCT00358449|Secondary|Number of Participants With Maintenance of Response|Participants who achieved a response of <5 esophageal eosinophils/HPF at Week 12 by worst case analysis, were evaluated for maintenance of response of <20 cells/HPF at Week 24. Response categories were defined as: non-responder (did not respond at Week 12 or Week 24); delayed responder (did not respond at Week 12 but responded at Week 24); relapsed (responded at Week 12 but not at Week 24); maintained (responded at Week 12 and Week 24). The following assumptions were made for worst case: if a Participant dropped out of the study due to lack of efficacy or an adverse event and had a missing response, their response was imputed as not achieved (i.e. failure). However for Participants withdrawn for other reasons (e.g. lost to follow-up) with a missing response (i.e. did not have the biopsy) the response was made as missing and not imputed.|Week 12 and Week 24|ITT Population. Only those participants were responders at Week 12 were analyzed.||Participants|||Number
726859|NCT00358449|Secondary|Change From Baseline in Percentage of Days With Feeling of Something Stuck in Throat (for Par. 8-17 Years)|The percentage of days with feeling of something stuck in throat during each analysis period (Baseline, Weeks 9-12 and Weeks 21-24) was calculated as the number of days the symptom was experienced divided by the number of days in the analysis interval, and presented as a percentage (ie, the proportion X 100%). Screening phase was considered as Baseline interval. Change from Baseline for each analysis interval was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA model with terms for Baseline score, treatment group, age group and treatment by age group interaction. The OC datasets with incorrect questionnaires excluded were used for the analysis.|Screening, Weeks 9-12 and Weeks 21-24|ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).||Percentage of days||95% Confidence Interval|Least Squares Mean
726860|NCT00358449|Secondary|Change From Baseline in Feeling of Something Stuck in Throat Bothersome Scores (for Par. 8-17 Years Only)|Par. and/or parent/guardian recorded daily symptoms of the feeling like something is stuck in throat on a hand held personal digital assistant (electronic diary) during the Screening Phase, TP, and FP. A score of 0 was assigned for days on which the symptom of feeling of something stuck was not experienced. On days that feeling of something stuck in the throat was experienced, the amount the symptom bothered the Par. was assessed as 1=not bothered at all, 2=bothered a little, 3=somewhat bothered, 4=bothered quite a bit, 5=bothered a whole lot. Average bothersome score was calculated as the sum of the respective scores for that interval divided by the number of days. Screening phase was considered as Baseline interval. Change from Baseline was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA models with terms for the relevant Baseline score, treatment group, age group and treatment by age interaction.|Screening, Weeks 9-12 and Weeks 21-24|ITT Population. The OC datasets with incorrect questionnaires excluded were the primary analysis. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).||Scores on a Scale||95% Confidence Interval|Least Squares Mean
726861|NCT00358449|Secondary|Change From Baseline in the Percentage of Days Participants Ate Solid Foods|The percentage of days with the symptom of difficulty and pain when eating solid foods during each analysis interval (Baseline, Weeks 9-12 and Weeks 21-24) was calculated as the number of days the symptom was experienced divided by the number of days in the analysis interval, and presented as a percentage (ie, the proportion X 100%). Screening phase was considered as Baseline interval. Change from Baseline for each analysis interval was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA model with terms for Baseline score, treatment group, age group and treatment by age group interaction. The OC datasets with incorrect questionnaires excluded were used for the analysis.|Screening, Weeks 9-12 and Weeks 21-24|ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).||Percentage of days||95% Confidence Interval|Least Squares Mean
726862|NCT00358449|Secondary|Change in Baseline in Pain With Eating Solid Foods Severity Scores|Par. and/or parent/guardian recorded daily symptoms of eosinophilic esophagitis on a hand held personal digital assistant (electronic diary) during the Screening Phase, TP, and FP. A score of 6 was assigned for that symptom when Par. did not eat. The severity of pain was assessed when Par. eats food as: 1=didn’t hurt at all, 2=hurt a little, 3=hurt somewhat, 4=hurt quite a bit, and 5=hurt a whole lot. The average pain severity for the interval (Baseline, Weeks 9-12, Weeks 21-24) was calculated as the sum of the pain severity scores for that interval (including days assigned as 6) divided by the number of days in the interval. Screening phase was considered as Baseline interval. Change from Baseline was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA models with terms for the relevant Baseline score, treatment group, age group and treatment by age group interaction.|Screening, Weeks 9-12 and Weeks 21-24|ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).||Scores on a scale||95% Confidence Interval|Least Squares Mean
726863|NCT00358449|Secondary|Change From Baseline in Difficulty With Eating Solid Foods|Par. and/or parent/guardian recorded daily symptoms of eosinophilic esophagitis on a hand held personal digital assistant (electronic diary) during the Screening Phase, TP and FP. A score of 6 was assigned for that symptom when Par. did not eat solid foods. When Par.eat solid foods, the amount of difficulty was assessed as 1=no difficulty, 2=a little difficulty, 3=some difficulty, 4=quite a bit of difficulty, 5=a whole lot of difficulty. The average pain severity for the interval (Baseline, Weeks 9-12, Weeks 21-24) was calculated as the sum of the pain severity scores for that interval (including days assigned as 6) divided by the number of days in the interval. Screening phase was considered as Baseline interval. Change from Baseline was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA models with terms for the relevant Baseline score, treatment group, age group and treatment by age group interactions.|Screening, Weeks 9-12 and Weeks 21-24|ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).||Scores on a scale||95% Confidence Interval|Least Squares Mean
726905|NCT00365976|Secondary|Roland Morris Low Back Pain Inventory (RMLBPI)|"The Roland-Morris Low Back Pain Disability Questionnaire (RMLBPDQ) is a 24-item instrument that assesses the extent to which activities of daily living are affected by LBP. It is composed of 24 “yes-no” items assessing potential disabilities.
Scores range from 0 (no disability) to 24 (severe disability)."|prenaprosyn baseline, postnaprosyn Baseline, Week 1, Week 2, week 4|||units on a scale||Standard Deviation|Mean
726864|NCT00358449|Secondary|Change From Baseline in Percentage of Days on Which the Participant Drank|The percentage of days with the symptom of difficulty and pain when participant drank during each analysis interval (Baseline, Weeks 9-12 and Weeks 21-24) was calculated as the number of days the symptom was experienced divided by the number of days in the analysis interval, and presented as a percentage (ie, the proportion X 100%). Screening phase was considered as Baseline interval. Change from Baseline for each analysis interval was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA model with terms for Baseline score, treatment group, age group and treatment by age group interaction. The OC datasets with incorrect questionnaires excluded were used for the analysis.|Screening, Weeks 9-12 and Weeks 21-24|ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).||Percentage of days||95% Confidence Interval|Least Squares Mean
726865|NCT00358449|Secondary|Change From Baseline in Pain With Drinking Severity Scores|Par. and/or parent/guardian recorded daily symptoms of eosinophilic esophagitis on a hand held personal digital assistant (electronic diary) during the Screening Phase, TP, and FP. A score of 6 was assigned the day participant did not drink. The severity of pain was assessed as: 1=didn’t hurt at all, 2=hurt a little, 3=hurt somewhat, 4=hurt quite a bit, and 5=hurt a whole lot. The average difficulty and pain severity scores was calculated as the sum of the respective scores for that interval divided by the number of days in the interval. . Screening phase was considered as Baseline interval. Change from Baseline was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA models with terms for the relevant Baseline score, treatment group, age group and treatment by age group interaction.|Screening, Weeks 9-12 and Weeks 21-24|ITT Population. The OC datasets with incorrect questionnaires excluded were used for the analysis. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).||Scores on a scale||95% Confidence Interval|Least Squares Mean
726866|NCT00358449|Secondary|Change From Baseline in Daily Degree of Difficulty With Drinking|Par. and/or parent/guardian recorded daily symptoms of eosinophilic esophagitis on a hand held personal digital assistant (electronic diary) during the Screening Phase, TP, and FP. A score of 6 was assigned days the participant did not drink. The amount of difficulty with drinking was assessed as 1=no difficulty, 2=a little difficulty, 3=some difficulty, 4=quite a bit of difficulty, 5=a whole lot of difficulty. The average difficulty for the interval (Baseline, Weeks 9-12, Weeks 21-24) was calculated as the sum of the drinking difficulty scores for that interval (including days assigned as 6) divided by the number of days in the interval. Screening phase was considered as Baseline interval. Change from Baseline was calculated as the value for that interval minus the value for the baseline interval. Analysis was performed using parametric ANCOVA models with terms for the relevant Baseline score, treatment group, age group and treatment by age group interaction.|Screening, Weeks 9-12 and Weeks 21-24|ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).||Scores on a Scale||95% Confidence Interval|Least Squares Mean
726867|NCT00358449|Secondary|Change From Baseline in Percentage of Days With Vomiting|The percentage of days with the symptom of vomiting during each analysis interval (Baseline, Weeks 9-12 and Weeks 21-24) was calculated as the number of days the symptom was experienced divided by the number of days in the analysis interval, and presented as a percentage (ie, the proportion X 100%). Screening phase was considered as Baseline interval. Change from Baseline for each analysis interval was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA model with terms for Baseline score, treatment group, age group and treatment by age group interaction. The OC datasets with incorrect questionnaires excluded were used for the analysis.|Screening, Weeks 9-12 and Weeks 21-24|ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).||Percentage of days||95% Confidence Interval|Least Squares Mean
726868|NCT00358449|Secondary|Change From Baseline in Frequency of Vomiting|Par. and/or parent/guardian recorded daily symptoms of eosinophilic esophagitis on a hand held personal digital assistant (electronic diary) during the Screening Phase, TP, and FP. A participant vomiting any time was counted as one episode of vomiting, irrespective of how close they are to each other. The daily frequency of vomiting was calculated as the total number of times the participant vomited during the interval divided by the number of days in the interval. Screening phase was considered as Baseline interval. Change from Baseline was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA models with terms for the relevant Baseline score, treatment group, age group and treatment by age group interaction.|Screening, Weeks 9-12 and Weeks 21-24|ITT Population. The OC datasets with incorrect questionnaires excluded were used for the analysis. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).||Occurrences of vomiting per day||95% Confidence Interval|Least Squares Mean
726869|NCT00358449|Secondary|Change From Baseline in Percentage of Days With Regurgitation Bothersome Scores|The percentage of days with the symptom of pain in regurgitation bothersome during each analysis interval (Baseline, Weeks 9-12 and Weeks 21-24) was calculated as the number of days the symptom was experienced divided by the number of days in the analysis interval, and presented as a percentage (ie, the proportion X 100%). Screening phase was considered as Baseline interval. Change from Baseline for each analysis interval was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA model with terms for Baseline score, treatment group, age group and treatment by age group interaction. The OC datasets with incorrect questionnaires excluded were used for the analysis.|Screening, Weeks 9-12 and Weeks 21-24|ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).||Percentage of days||95% Confidence Interval|Least Squares Mean
726900|NCT00358579|Secondary|Neurological Status on Discharge or at 30 Days Post Arrest, if Not Discharged.|Neurological status is assessed by the Glasgow-Pittsburgh outcome categories, to evaluate quality of life after successful resuscitation. Good neurological status is defined as cerebral performance categories(CPC)/overall performance categories(OPC):1 and 2.CPC/OPC 1 indicates good cerebral & overall performance. CPC/OPC 2 indicates moderate cerebral & overall disability. CPC/OPC 3 indicates severe cerebral & overall disability. CPC/OPC 4 indicates coma, vegetative state. CPC/OPC 5 indicates brain dead/death.|at 30 days post arrest|||Participants|||Number
726870|NCT00358449|Secondary|Change From Baseline in Regurgitation Bothersome Scores|Par. and/or parent/guardian recorded daily symptoms of eosinophilic esophagitis on a hand held personal digital assistant (electronic diary) during the Screening Phase, TP, and FP. A score of 0 was assigned for days on which the symptom regurgitation was not experienced. The days regurgitation experienced, the amount the symptom bothered the Par. was assessed as 1=not bothered at all, 2=bothered a little, 3=somewhat bothered, 4=bothered quite a bit, 5=bothered a whole lot. The average pain severity for the interval (Baseline, Weeks 9-12, Weeks 21-24) was calculated as the sum of the pain severity scores for that interval (including days assigned as 0) divided by the number of days in the interval. Screening phase was considered as Baseline interval. Change from Baseline was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA models with terms for Baseline score, treatment group, age group interactions|Screening, Weeks 9-12 and Weeks 21-24|ITT Population. The OC datasets with incorrect questionnaires excluded were the primary analysis. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).||Scores on a scale||95% Confidence Interval|Least Squares Mean
726871|NCT00358449|Secondary|Change From Baseline in Percentage of Days With Pain in Chest/Throat|The percentage of days with the symptom of pain in chest/throat during each analysis interval (Baseline, Weeks 9-12 and Weeks 21-24) was calculated as the number of days the symptom was experienced divided by the number of days in the analysis interval, and presented as a percentage (ie, the proportion X 100%). Screening phase was considered as Baseline interval. Change from Baseline for each analysis interval was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA model with terms for Baseline score, treatment group, age group and treatment by age group interaction. The OC datasets with incorrect questionnaires excluded were used for the analysis.|Screening, Weeks 9-12 and Weeks 21-24|ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).||Percentage of days||95% Confidence Interval|Least Squares Mean
726872|NCT00358449|Secondary|Change From Baseline in Percentage of Days With Pain in Stomach|The percentage of days with the symptom of pain in stomach during each analysis interval (Baseline, Weeks 9-12 and Weeks 21-24) was calculated as the number of days the symptom was experienced divided by the number of days in the analysis interval, and presented as a percentage (ie, the proportion X 100%). Screening phase was considered as Baseline interval. Change from Baseline for each analysis interval was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA model with terms for Baseline score, treatment group, age group and treatment by age group interaction. The OC datasets with incorrect questionnaires excluded were used for the analysis.|Screening, Weeks 9-12 and Weeks 21-24|ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).||Percentage of days||95% Confidence Interval|Least Squares Mean
726873|NCT00358449|Secondary|Change From Baseline in Pain in Chest/Throat Severity Scores|Par. and/or parent/guardian recorded daily symptoms of eosinophilic esophagitis on a hand held personal digital assistant (electronic diary) during the Screening Phase, TP, and FP. A severity score of 0 was assigned for days on which pain in chest/throat was not experienced. If pain in chest/throat was reported, severity of pain was assessed as: 1=hurt a little, 2=hurt somewhat, 3=hurt quite a bit, and 4=hurt a whole lot. The average pain severity for the interval (Baseline, Weeks 9-12, Weeks 21-24) was calculated as the sum of the pain severity scores for that interval (including days assigned as 0) divided by the number of days in the interval. Screening phase was considered as the Baseline interval. Change from Baseline was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA models with terms for the relevant Baseline score, treatment group, age group and treatment by age group interaction.|Screening, Weeks 9-12 and Weeks 21-24|ITT Population. The OC datasets with incorrect questionnaires excluded were used for the analysis. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).||Scores on a scale||95% Confidence Interval|Least Squares Mean
726874|NCT00358449|Secondary|Change From Baseline in Pain in Stomach Severity Scores|Par.and/or parent/guardian recorded daily symptoms of eosinophilic esophagitis on a hand held personal digital assistant (electronic diary) during the Screening Phase, TP, and FP. A severity score of 0 was assigned for days on which pain in stomach was not experienced. If pain in stomach was reported, severity of pain was assessed as: 1=hurt a little, 2=hurt somewhat, 3=hurt quite a bit, and 4=hurt a whole lot. The average pain severity for the interval (Baseline, Weeks 9-12, Weeks 21-24) was calculated as the sum of the pain severity scores for that interval (including days assigned as 0) divided by the number of days in the interval. Screening phase was considered as the Baseline interval. Change from Baseline was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric Analysis of Covariance (ANCOVA) models with terms for the relevant Baseline score, treatment group, age group and treatment by age group interaction|Screening, Weeks 9-12 and Weeks 21-24|ITT Population. The observed case (OC) datasets with incorrect questionnaires excluded were used for the analysis. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).||Scores on a scale||95% Confidence Interval|Least Squares Mean
726875|NCT00358449|Primary|Plasma Clearance (CL) of Mepolizumab|Clearance is defined as the removal of drug from a volume of plasma in a given unit of time (drug loss from the body). Blood samples were obtained at pre-infusion and 5m, 2h, 24h, 72-96h post-infusion at Day 1, Weeks 4, 8; and Weeks 2, 6 10, 12, 16, 20, 24 and 34 from each participant to estimate plasma clearance of mepolizumab.|Day 1, Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, and 34|Pharmacokinetic Population||Liters per Day (L/day)||95% Confidence Interval|Geometric Mean
726901|NCT00358579|Primary|Survival to Hospital Discharge.|Survival to hospital discharge is defined as the patient leaving the hospital alive or survival to 30 days post cardiac arrest,whichever came first. This therefore measures the number of participants who was discharged alive or survived to 30 days post cardiac arrest, whichever came first.|at 30 days post arrest|||Participants|||Number
726902|NCT00365976|Secondary|State-Trait Anxiety Inventory (STAI)|Self-rating assessment of anxiety measured by STAI, state anxiety inventory (Scale 40-160, where a lower value shows a larger improvement)|Baseline, week 1, week 2, week 4|Data not collected.|||||
726906|NCT00365976|Secondary|Patient Global Impression of Pain Ratings|Pain ratings included a global impression of pain rating (PGI) (1-5 rating with 1 being little pain and 5 is worst pain)|postnaprosyn Baseline, Week 1, Week 2 week 4|||units on a scale||Standard Deviation|Mean
726876|NCT00358449|Primary|Central (V1), Periperial (V2) and Steady-State (Vss) Volume of Distribution of Mepolizumab|Volume of distribution is defined as the theoretical volume in which the total amount of drug is uniformly distributed to produce the desired plasma concentration of a drug. Central volume of distribution is a hypothetical volume into which a drug initially distributes upon administration. Peripheral volume of distribution is the sum of all tissue spaces outside the central compartment. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state. Blood samples were obtained at pre-infusion and 5m, 2h, 24h, 72-96h post-infusion at Day 1, Weeks 4, 8; and Weeks 2, 6 10, 12, 16, 20, 24 and 34 from each participant to estimate central (V1) and periperial (V2) and Steady State (Vss) volume of distribution of mepolizumab.|Day 1, Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, and 34|Pharmacokinetic Population: all participants who received study medication and for whom mepolizumab sample was obtained and analyzed.||Liters||95% Confidence Interval|Geometric Mean
726877|NCT00358449|Primary|Number of Participants Achieving a Reduction in Peak Esophageal Eosinophil Count to < 5 Cells Per High Power Field (HPF) at Week 12|A responder was defined as a participant achieving a reduction in esophageal eosinophils to <5 cells per HPF as the highest count of eosinophils per HPF in all the esophageal sites biopsied at Week 12, confirmed by biopsy at Week 12 or at an early withdrawal visit prior to Week 12. A worst case (WC) approach was considered, if a particiapant withdrew prematurely : If a particiapnt dropped out of the study without having a biopsy taken, due to lack of efficacy or an adverse event, their response was imputed as not achieved. Participants who withdrew, without a biopsy, for other reasons (e.g. lost to follow-up) were considered non-evaluable for the primary analysis. For participants who withdrew early from the study and had a biopsy, the biopsy was used to determine their response.|Week 12|ITT Population-WC||Participants|||Number
726878|NCT00358449|Primary|Number of Participants With Positive and Negative Anti-mepolizumab Antibody Results at Any Visit and Repeat Visit.|Blood samples for testing anti-mepolizumab antibodies were collected on Day 1, Week 4 and 8 Infusion Visit (before the IV infusion) and at Week 12, 24 and 34 Week follow-up visits. The presence of anti-human mepolizumab antibodies was assessed using an immunoelectrochemiluminescent (ECL) assay. To address transient positive results, an assessment of repeated results were made. For any visit category: results were considered as positive if it was positive at any visit during the study, and results were considered as negative if it were negative at all visits during the study. For repeat visit category: results were considered as postive if the result was positive at >1 visit, and results were considered as negative if the result was negative at all visits or was positive at only one visit.|Day 1, Weeks 4, 8, 12, 24, and 34|ITT Population||Participants|||Number
726879|NCT00358449|Primary|Change From Baseline in Temperature at the Indicated Time Points|Temperature measurements were obtained at the following time points: Screening, Day 1, and Weeks 4, 8, 12, 16, 20 and 24. Screening value was considered as the Baseline value. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Screening, Day 1, Weeks 4, 8, 12, 16, 20 and 24|ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).||Degree Celsius (°C)||Standard Deviation|Mean
726880|NCT00358449|Primary|Change From Baseline in Heart Rate at the Indicated Time Points|Heart rate measurements were obtained at the following time points: Screening, pre-infusion, 10m, 30m, 1h, 2h post-infusion on Day 1, Week 4, Week 8; and Weeks 12, 16, 20 and 24. Screening value was considered as the Baseline value. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Screening, Day 1, Weeks 4, 8, 12, 16, 20, and 24|ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).||Beats per minutes||Standard Deviation|Mean
726881|NCT00358449|Primary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points|SBP and DBP measurements were obtained at the following time points: screening, pre-infusion, 10 minutes (m), 30m, 1 hour (h), 2h post-infusion on Day 1, Week 4, Week 8; and Weeks 12, 16, 20 and 24. Screening value was considered as the Baseline value. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Screening, Day 1, Weeks 4, 8, 12, 16, 20, and 24|ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).||Millimeters of mercury (mmHg)||Standard Deviation|Mean
726882|NCT00358449|Primary|Number of Participants With the Indicated Change From Baseline in ECG Findings at Any Time Post-Baseline|12-lead ECG assessments were obtained at the following time points: screening, and Weeks 4, 8 and 12.. Overall ECG findings were summarized using the worst case findings without regard to visits ie. “any time post Baseline”. Change from Baseline in ECG findings were categorized as clinically significant change from Baseline; no clinically significant change from Baseline and not applicable.|Screening, Weeks 4, 8 and 12|ITT Population||Participants|||Number
726883|NCT00358449|Primary|Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period.|Blood samples were collected pre-infusion at Day 1, Week 4 and Week 8; and 24h and 72h post-infusion at Day 1, Week 4 and Week 8 time points and at Weeks 2, 6, 10, 12, 16, 20, 24, and 34 to estimate the following hematology parameters: basophils (Bas), percentage of basophils (% Bas), lymphocytes (Lym), percentage of Lym (% Lym), monocytes (Mon), percentage of Mon (% Mon), platelet count (PC), total neutrophils (TN), percentage of TN (% TN), white blood cell count (WBC), hematocrit (He), hemoglobin (Hg), and red blood cell count (RBC). Laboratory abnormalities outside the reference range (high and low values) at any time post baseline were presented. Any time post Baseline = all visits (including scheduled and unscheduled). If participant had given both high and low value at least once then participant is counted under both high and low category for this visit.|From first dose of study treatment (Day 1) up to Long-term Follow-up Phase (Week 34)|ITT Population. Only those participants available at specified time points are analyzed.||Participants|||Number
726903|NCT00365976|Secondary|Short Form 36 Health Survey Questionnaire (SF-36)|The SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The vitality sub-score assesses energy and fatigue, and ranges from 0 (worst) - 100 (best).|Baseline, week 1, week 2, week 4|Data not collected.|||||
726904|NCT00365976|Secondary|Hamilton Depression Rating Scale (HAM-D-24)|The Hamilton Depression Scale - 24 Items (HAM-D-24) measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 76. The higher the score, the more severe.|prenaprosyn baseline, postnaprosyn Baseline, Week 1, Week 2, week 4|||units on a scale||Standard Deviation|Mean
726884|NCT00358449|Primary|Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period.|Blood samples were collected at Day 1, Weeks 4, 8, 12, 16, 20 and 24 to estimate the following biochemistry parameters: alanine amino transferase (ALT), aspartate amino transferase (AST), albumin (Ab), total protein (ToP), creatinine (Cr), total bilirubin (TB), calcium (Ca), bicarbonate (Bi), chloride (Cl), glucose (Glu), potassium (Pot), and sodium (Sod). Laboratory abnormalities outside the reference range (high and low values) at any time post baseline were presented. Any time post Baseline = all visits (including scheduled and unscheduled). If participant had given both high and low value at least once then participant is counted under both high and low category for this visit.|From first dose of study treatment (Day 1) up to Follow-up Phase (Week 24)|ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).||Participants|||Number
726885|NCT00358449|Primary|Number of Participants With Any Adverse Events (AE), Any Serious Adverse Event (SAE) and Drug-related AE During Treatment Phase (TP) and Follow-up Phase (FP)|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event is defined as any untoward medical occurrence that, at any dose that Results in death, life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; a congenital anomaly/birth defect. Drug-related AE’s were considered to have a reasonable possibility of being related to treatment by the investigator. AE, SAE and drug-related AEs are summarized by TP and FP.|From first dose of study treatment (Day 1) up to Follow-up Phase (Week 24)|Intention-to-Treat (ITT) Population: all participants who gave informed consent, were randomized and received at least one dose of medication.||Participants|||Number
726886|NCT00358462|Primary|mITT Analysis of Eradication of U. Urealyticum at First Follow-up Visit|Microbiologic cure, defined as negative PCR for U. urealyticum (if cultured), or negative culture at first follow-up visit|3 weeks (allowable window 2-5)|mITT population (defined as urethral symptoms or visible discharge plus >=5PMNs/HPF at baseline) who tested positive for U. urealyticum at baseline||participants|||Number
726887|NCT00358462|Secondary|Clinical Cure as Measured by the Absence of Recurrent or Persistent Signs and/or Symptoms of Urethral Infection Among Case Subjects Who Were Positive for M. Genitalium or Ureaplasmas at the Initial Study Visit||approximately 3 weeks after initial study visit (allowable window is 2-5 weeks after initial study visit)||||||
726888|NCT00358462|Secondary|Minimum Inhibitory Concentrations (MIC) of All Cultivable Strains of M. Genitalium and Ureaplasmas||on-going||||||
726889|NCT00358462|Primary|mITT Analysis of Eradication of M. Genitalium at First Follow-up Study Visit|Microbiologic cure of M. genitalium at first follow-up visit (defined as a negative in-house PCR test performed on urine)|approximately 3 weeks after initial study visit (allowable window is 2-5 weeks after initial study visit)|mITT population (defined as urethral symptoms or visible discharge plus >=5PMNs/HPF at baseline) who tested positive for M. genitalium at baseline||participants|||Number
726890|NCT00358501|Other Pre-specified|Historical Control Group Adverse Event Information|Historical Control group was not assessed for severity|Through 30 days from the last dose of Defibrotide|||Number of patients|||Number
726891|NCT00358501|Secondary|Percentage of Participants With Treatment-Emergent Adverse Events||Through 30 days from the last dose of Defibrotide|Safety population||percentage of participants|||Number
726892|NCT00358501|Secondary|Survival at Day+180 Post Hematopoietic Stem Cell Transplantation|The 95.1% CI instead of 95% CI is used for the final analysis to provide a small adjustment for the fact that an interim analysis was performed.|180 days post hematopoietic stem cell transplant|Intent-to-Treat||percentage of participants||95.1% Confidence Interval|Number
726893|NCT00358501|Primary|Complete Response by Day+100 Post Hematopoietic Stem Cell Transplant|The 95.1% CI instead of 95% CI is used for the final analysis to provide a small adjustment for the fact that an interim analysis was performed.|Day+100 post hematopoietic stem cell transplant|Intent-to-Treat||percentage of participants||95.1% Confidence Interval|Number
726894|NCT00358501|Primary|Survival at Day+100 Following Hematopoietic Stem Cell Transplant|The 95.1% CI instead of 95% CI is used for the final analysis to provide a small adjustment for the fact that an interim analysis was performed.|Day+100 post hematopoietic stem cell transplant|Intent-to-Treat||percentage of participants||95.1% Confidence Interval|Number
726895|NCT00358527|Primary|Mean Change From Baseline (Day 1/Visit 3) in the Sleep Problems Index II (SLP9) Score From the Medical Outcome Study Sleep Scale (MOS-SS) at the Day 29 Visit.|"Following Visit 2 (Screening), at Baseline, Day 15, and Day 29 visits, participants needed to complete the MOS-SS questionnaire with scores from 1 = all of the time to 6 = none of the time, according to their frequency of occurrence during the previous week. The analysis endpoint MOS-SS Sleep Problems Index II (SLP9) score was derived from MOS-SS questionnaire and scaled from 0 = none of the time to 100 = all of the time.
NOTE: Least squares means and standard errors were obtained from an ANCOVA model with the treatment effect and the variable specific Baseline as a covariate."|29 days|Modified Intent-to-Treat (MITT) Population: all randomized subjects with any post-baseline data and without concomitant medications that could significantly bias the co-primary endpoints.||Units on a scale||Standard Error|Least Squares Mean
726896|NCT00358527|Primary|Mean Change of the AM-PRIOR-reflective (Participant's Status Over the Previous 12 Hours) Total Nasal Symptoms Severity Score (TNSS) Averaged Over the Last 7 Days of Treatment From the Baseline Score.|"The TNSS score included the sum of nasal congestion/stuffiness, rhinorrhea/nasal discharge, sneezing, and nasal itching, each scored on a scale of 0 = absent, 1 = mild, 2 = moderate, 3 = severe. The TNSS score could range from 0 to 12.
NOTE: Least square means and standard errors were obtained from an ANCOVA model with the treatment effect and the variable specific Baseline as a covariate."|Average of the last 7 days of treatment|Modified Intent-to-Treat (MITT) Population: all randomized subjects with any post-baseline data and without concomitant medications that could significantly bias the co-primary endpoints.||Units on a scale||Standard Error|Least Squares Mean
726897|NCT00358579|Secondary|Survival to Admission.|Survival to admission is defined as the presence of pulse on admission to hospital (discharged from Emergency Department and admitted to Intensive Care Units /wards). This measures the number of participants with pulse and who were admitted to hospital.|No specific time frame. Survival to admission refers to sustained return of spontaneous circulation until admission and transfer of care to Intensive Care Units /wards|||Participants|||Number
726907|NCT00365976|Secondary|Insomnia Severity Index (ISI)|The ISI is a seven-item self-report questionnaire that provides a global measure of insomnia severity based on difficulty falling or staying asleep, satisfaction with sleep, or degree of impairment with daytime functioning. The total score ranges from 0–28: 0–7 (no clinical insomnia), 8–14 (subthreshold insomnia), 15–21 (insomnia of moderate severity), and 22–28 (severe insomnia).|Prenaprosyn Baseline, Postnaprosyn Baseline, Week 1, Week 2 week 4|||units on a scale||Standard Deviation|Mean
726908|NCT00365976|Secondary|Sleep Quality Ratings|Sleep quality ratings are based on a 1-10 Likert scale. Low scores represent poorer sleep quality and higher scores represent better quality sleep|Postnaprosyn Baseline, Week 1, Week 2 week 4|||units on a scale||Standard Deviation|Mean
726909|NCT00365976|Secondary|Number of Awakenings||Postnaprosyn Baseline, Week 1, Week 2 week 4|||awakenings||Standard Deviation|Mean
726910|NCT00365976|Secondary|Wake Time After Sleep Onset||Postnaprosyn Baseline, Week 1, Week 2 week 4|||minutes||Standard Deviation|Mean
726911|NCT00365976|Secondary|Mean Sleep Onset Latency (SOL)||Postnaprosyn Baseline, Week 1, Week 2 week 4|||minutes||Standard Deviation|Mean
726912|NCT00365976|Secondary|Visual Analog Scale Pain Ratings (VAS)|Scores are measured on a 100 mm Visual Analog Scale (VAS). The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain|Postnaprosyn baseline, Week 1, Week 2, Week 4|||units on a scale||Standard Deviation|Mean
726913|NCT00365976|Primary|Mean Subjective Sleep Diary Derived Total Sleep Time (TST)|Nightly total sleep time was averaged from diary entries.|Postnaprosyn baseline, Week 1, week 2, week 4|||Minutes||Standard Deviation|Mean
726914|NCT00366028|Primary|Effect Size of Improvement in Hand Hygiene Compliance|The effect size of improvement in hand-hygiene compliance was calculated by comparing the baseline three-month periods to the last three-month periods of the study. To evaluate the statistical significance of changes in proportion adherence over time, we ran a weighted least squares regression model with time (i.e. month) as the independent variable and adherence proportion as the dependent variable. The sample size in each data collection period was used as the weight. Our interest is in the statistical significance of the coefficient associated with time. To evaluate the practical significance of the change pre and post intervention, we examined the effect size associated with the change in proportion adherence in the first 3-month period of data collection and the last 3-month period. Effect size was calculated as 2*arcsin(sqr(p2)) - 2*arcsin(sqr(p1)). Using Cohen's criteria, an effect size of .2 is interpreted as small, .5 as medium and .8 as large.|3 months pre and post study intervention|This outcome measure was only assessed at the site (facility) level.||effect size|Participants||Number
726915|NCT00366028|Primary|Fidelity to the Organizational Model|"Final fidelity to the Organizational Model was assessed by averaging scores for each component of the model. Scores ranged from 0 (no evidence of that factor present) to 4 (factor fully present and used as intended). The 3 main components of the model included 1) active leadership commitment to quality, 2) robust clinical process redesign to incorporate evidence-based practices into routine operations, and 3) use of management structures and processes to support and align redesign. Scores for each component of the model were measured by the study team using structured rating instruments based on data collected during interviews.
Sites with an overall fidelity score above 3.0 were considered to have high fidelity to the organizational model."|Fidelity was assessed at the end of the 3 year study.|This outcome measure was only assessed at the site (facility) level.||units on a scale|Participants||Number
726916|NCT00366106|Secondary|Relative Dose Intensity of Bortezomib|Relative dose intensity is defined as actual dose/scheduled dose. Bortezomib is administered on Days 1, 4, 15, and 18 every 28 days.|Each dose of bortezomib (days 1, 4, 15, and 18 every 28 days)|Note that the sample sized varied at each dose and ranged from 32 patients to 1 patient.||Relative dose intensity||Standard Deviation|Mean
726917|NCT00366106|Secondary|Number of Participants With Treatment Response|Complete Response (CR), Partial Response (PR), and Minor Response (MR) each required stable bone disease and normal calcium levels. CR also required 100% serum protein electrophoresis (SPEP) reduction, negative immunofixation (IF), 100% urine protein electrophoresis (UPEP)reduction, and <5% plasma cells in bone marrow. PR also required >=50% SPEP reduction, >=90% UPEP reduction, and >=50% reduction in plasma cells in bone marrow. MR also required >=25% SPEP reduction, >=50% UPEP reduction, and > 25% reduction in plasma cells.|Every 8 weeks from start of treatment until end of treatment|||Participants|||Number
726918|NCT00366106|Secondary|Time to Progression (TTP)||TTP was measured from day 1 of treatment until time of progression, assessed up to 40 months|||Months||Standard Deviation|Mean
726919|NCT00366106|Primary|Incidence of Treatment-emergent Peripheral Neuropathy||Every 4 weeks from start of treatment until end of treatment|||Participants|||Number
726920|NCT00366249|Secondary|Number of Patients With Microbiologic Response of Eradication.|Eradication defined as: no pathogen is present in the repeat culture from the original site of infection, or a clinical response of the cure precludes the availability of a specimen for culture.|Test of cure visit (TOC): Assessed at least 12 days post last dose|Microbiologically evaluable population without osteomyelitis.||patients|||Number
726921|NCT00366249|Secondary|Number of Patients With Clinical Response of Cure Vs. Failure/Indeterminate Assessed at Least 25 - 27 Weeks Post Last Dose.|Cure: Recovery so no added antibiotic therapy. Failure: Added antibiotic therapy for no response or worsening after improvement, new purulence, >120% doses, non-routine surgical treatment or death related to DFI > 48 hrs. Indeterminate: Lost to follow-up, death<48 hours or noninfection related.|Test of cure visit (TOC): Assessed at least 25 - 27 weeks post last dose|Clinical modified intent to treat population with osteomyelitis.||patients|||Number
726922|NCT00366249|Primary|Number of Patients With Clinical Response of Cure Vs. Failure/Indeterminate.|Cure: Recovery so no added antibiotic therapy. Failure: Added antibiotic therapy for no response or worsening after improvement, new purulence, >120% doses, non-routine surgical treatment or death related to DFI > 48 hrs. Indeterminate: Lost to follow-up, death<48 hours or noninfection related.|Test of cure visit (TOC): Assessed at least 12 days post last dose|Clinical modified intent to treat population without osteomyelitis.||patients|||Number
726923|NCT00366249|Secondary|Number of Patients With Clinical Response of Cure Vs. Failure Assessed at Least 25 - 27 Weeks Post Last Dose.|Cure: Recovery so no added antibiotic therapy. Failure: Added antibiotic therapy for no response or worsening after improvement, new purulence, >120% doses, non-routine surgical treatment or death related to DFI > 48 hrs.|Test of cure visit (TOC): Assessed at least 25 - 27 weeks post last dose|Clinically evaluable population with osteomyelitis.||patients|||Number
726924|NCT00366249|Primary|Number of Patients With Clinical Response of Cure Vs. Failure.|Cure: Recovery so no added antibiotic therapy. Failure: Added antibiotic therapy for no response or worsening after improvement, new purulence, >120% doses, non-routine surgical treatment or death related to Diabetic Foot Infections (DFI) > 48 hrs.|Test of cure visit (TOC): Assessed at least 12 days post last dose|Clinically evaluable population without osteomyelitis.||patients|||Number
726925|NCT00366275|Primary|Progression-free Survival|"PFS is calculated according to the Kaplan-Meier estimator. The observation time of each subject is defined as the time from entry into the study until lymphoma progression or death as a result of any cause whichever occurs first.
The 5-year PFS is the estimated cumulative probability of surviving at least 5 years without progression."|every 3 months for the first year after autotransplant and every 6 months after the first year of follow up|||percent chance of PFS at 5 years||95% Confidence Interval|Number
726926|NCT00371839|Primary|Ability to Understand Speech in Noise Background|Measure speech perception for sentences in background noise|one year|||Percent correct of 100 presented words||Standard Deviation|Mean
726927|NCT00371865|Secondary|Pain Anxiety Symptom Scale - 20|This questionnaire measures pain-related anxiety. Scores range from 0 to 100, with higher scores indicating higher levels of anxiety.|12 weeks (post treatment)|||units on a scale||Standard Deviation|Mean
726928|NCT00371865|Secondary|Beck Depression Inventory|This questionnaire measures depressive symptoms. Scores range from 0 to 63, with higher scores indicating higher levels of depressive symptoms.|12 weeks (post treatment)|||units on a scale||Standard Deviation|Mean
726929|NCT00371865|Secondary|SF-12|This questionnaire measures quality of life. Scores range from 0 to 100, with higher scores indicating better quality of life.|12 weeks (post treatment)|||units on a scale||Standard Deviation|Mean
726930|NCT00371865|Secondary|West Haven-Yale Multidimensional Pain Inventory - Activity Subscales|This questionnaire measures levels of activity that can be affected by pain. Full measure has a range of 0-6, with higher scores indicating higher levels of activity.|12 weeks (post treatment)|||units on a scale||Standard Deviation|Mean
726931|NCT00371865|Primary|Brief Pain Inventory|This questionnaire measures pain severity and interference. Scores range from 0-10, with higher scores indicating more pain.|12 weeks (post treatment)|||units on a scale||Standard Deviation|Mean
726932|NCT00372060|Other Pre-specified|Change From Baseline in Hemoglobin A1c (HbA1c ) at Week 52|Change from the last value before receiving sitagliptin therapy: Week 0 for Sitagliptin/Sitagliptin group and Week 12 for the Placebo/Sitagliptin group.|Week 52 (reflecting change from Week 0) for Sitagliptin/Sitagliptin group; Weeks 52 (reflecting change from Week 12) for Placebo/Sitagliptin group.|The Completers Population (CP) includes all randomized patients who took at least 1 dose of sitagliptin and had [1] a baseline (Sitagliptin/Sitagliptin group) or Week 12 (Placebo/Sitagliptin group) value and [2] a value at Week 52.||Percent||95% Confidence Interval|Mean
726933|NCT00372060|Other Pre-specified|Change From Baseline in 2 Hour Postprandial Glucose at Week 12|Change from baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication.|12 weeks|Analysis in the Full Analysis Set without Last Observation Carried Forward (The Full Analysis Set population includes all randomized patients who took at least 1 dose of study medication and had both a baseline and at least one post-baseline values.).||mg/dL||95% Confidence Interval|Least Squares Mean
726934|NCT00372060|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 12|Change from baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication.|12 Weeks|Analysis in the Full Analysis Set with Last Observation Carried Forward (The Full Analysis Set population includes all randomized patients who took at least 1 dose of study medication and had both a baseline and at least one post-baseline value.)||mg/dL||95% Confidence Interval|Least Squares Mean
726935|NCT00372060|Primary|Change From Baseline in Hemoglobin A1c (HbA1c ) at Week 12|Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication.|12 Weeks|Analysis in the Full Analysis Set with Last Observation Carried Forward (The Full Analysis Set population includes all randomized patients who took at least 1 dose of study medication and had both a baseline and at least one post-baseline value.)||Percent||95% Confidence Interval|Least Squares Mean
726936|NCT00372190|Secondary|Bulge Symptoms|"Bulge symptoms defined as Prolapse domain score of the Urogenital Distress Inventory (UDI) at 12 months.
Scores range from 0 (least/no bother) to 100 (maximum bother)"|12 months|||units on a scale||Standard Deviation|Mean
726937|NCT00372190|Secondary|"Patient Global Impression of Improvement (PGI-I) at 12 Months"|Number of participants with much to very much improvement compared to baseline|at 12 months|||participants|||Number
726938|NCT00372190|Secondary|Mesh Exposure at 12 Months|cumulative number of patients with mesh exposure at 12 months (if diagnosed at 6 weeks or 6 months and treated, the exposure is calculated at 12 months, even if the exposure was not there anymore)|12 months|||participants|||Number
726939|NCT00372190|Primary|"Prolapse by Pelvic Organ Prolapse Quantification System (POP-Q), at 12 Months"|"Number of participants with anatomic failures defined as Pelvic Organ Prolapse (POP) stage II or higher"|12 months|||participants|||Number
726940|NCT00372385|Secondary|Maximum (Cmax), Minimum (Cmin) and Average (Cavg) Plasma Concentration of Telaprevir|Only subjects who received telaprevir were to be analyzed for this outcome. Maximum, minimum and average plasma concentrations observed during assessment period were reported.|Day 1, 4, 8, 15, 22, 29, 43, 57, 71, 85|Pharmacokinetic population included all subjects who provided pharmacokinetic assessments and had evaluable and interpretable data.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
726941|NCT00372385|Secondary|Number of Subjects With Viral Relapse|Viral relapse was defined as having detectable HCV RNA during antiviral follow-up. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).|After last dose of study drug up to antiviral follow-up (up to Week 72)|Analysis population included subjects who completed their assigned study drug treatment and had undetectable HCV RNA at the completion of treatment (up to Week 48).||participants|||Number
726979|NCT00372593|Secondary|Disease-free Survival (DFS)|Time from end of Intensification I to relapse, death or last contact|At 3 years from end of Intensification I|Ineligible (n=42) patients are excluded. Patients who did not continue on therapy at end of Intensification I are also excluded (n=247).||Percentage participants DFS at 3 years||95% Confidence Interval|Number
726942|NCT00372385|Secondary|Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)|"AE: any adverse change from the subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Study drug includes all investigational agents (including placebo, if applicable) administered during the course of the study."|Baseline up to Week 48|The Full Analysis set included all randomized subjects who received at least 1 dose of study drug.||participants|||Number
726943|NCT00372385|Secondary|Percentage of Subjects With Undetectable Plasma HCV RNA at Completion of Study Drug Dosing|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).|Completion of study drug dosing (up to Week 48)|The Full Analysis set included all randomized subjects who received at least 1 dose of study drug.||percentage of participants||95% Confidence Interval|Number
726944|NCT00372385|Secondary|Percentage of Subjects With Undetectable Plasma HCV RNA at Week 12 After the Completion of Study Drug Dosing|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).|12 weeks after the completion of study drug dosing (up to Week 60)|The Full Analysis set included all randomized subjects who received at least 1 dose of study drug.||percentage of participants||95% Confidence Interval|Number
726945|NCT00372385|Primary|Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Study Drug Dosing|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).|24 weeks after the completion of study drug dosing (up to Week 72)|The Full Analysis set included all randomized subjects who received at least 1 dose of study drug.||percentage of participants||95% Confidence Interval|Number
726946|NCT00372411|Secondary|Change in the Modified Ashworth Scale for Spasticity at 12 Weeks Relative to Baseline|The Modified Ashworth Scale for spasticity is a measurement of spasticity across 9 muscle groups. Each muscle group is scored on a 0 to 5 scale with higher scores indicating worse functioning. The total score is the average score from the 9 muscle groups and ranges from 0 to 5 with higher scores indicating worse functioning.|12 weeks minus baseline|||units on a scale||Standard Error|Least Squares Mean
726947|NCT00372411|Secondary|Change in the Numeric Rating Scale (NRS) at 12 Weeks Relative to Baseline|The Numeric Rating Scale (NRS) for pain is a self report scale ranging from 0 (no Pain) to 10 (pain as bad as you can imagine).|12 weeks minus baseline|||units on a scale||Standard Error|Least Squares Mean
726948|NCT00372411|Secondary|Wolf Motor Function Test|The Wolf Motor Function Test (WMFT) is a functionally-based test designed to provide an objective measure of both proximal (during tasks such as lifting the hand from table to box top) and distal control (grasping pencil, bringing soda can to mouth) of the paretic arm for patients after stroke or traumatic brain injury. The WMFT consists of 17 items, of which 15 measure time to perform functional tasks. The tasks are averaged to produce a score in seconds that ranges from 0 to 120 seconds, with higher scores indicating worse functioning. Outcome measure is the change in the Wolf score at 6, 12, 24 and 36 weeks relative to baseline.|6, 12, 24 and 36 weeks minus baseline|||Seconds||Standard Error|Least Squares Mean
726949|NCT00372411|Secondary|Stroke Impact Scale|The Stroke Impact Scale (SIS) is stroke specific, self-reported measure that evaluates function and quality of life in eight clinically relevant domains. The domains of hand function, activities of daily living, instrumental activities of daily living, mobility, and social participation were used; total score ranges from 0 to 100 with higher values indicating better functioning. Outcome is change at 6, 12, 24 and 36 weeks relative to baseline.|6, 12, 24 and 36 weeks minus baseline|||units on a scale||Standard Error|Least Squares Mean
726950|NCT00372411|Primary|Fugl-Meyer Assessment for Motor Recovery (FM) Scale|Fugl-Meyer (FM) is a standard instrument for the quantitative clinical assessment of motor impairment and function. In this study the upper extremity subsection of the FM was used. The FM assesses several impairment dimensions by using a 3 point ordinal scale: 0 = cannot perform, 1 = can perform partially and 2 = can perform fully. These measures are summed to an overall score is Scoring for upper extremity FM ranges from 0 (worst, completely plegic) to 66 (best, normal). Higher scores indicate better functioning. Outcome measure is the change in the FM score at 6, 12, 24 and 36 weeks relative to baseline.|6, 12, 24 and 36 weeks minus baseline|All participants with baseline and follow-up measures were included by intention-to-treat||units on a scale||Standard Error|Least Squares Mean
726951|NCT00372424|Other Pre-specified|Maximum Observed Plasma Concentration (Cmax) of Paclitaxel||End of infusion (1 H) on Day 1 of Cycle 1, 2, 4 and 6|Data not analyzed since paclitaxel was not administered in the study.|||||
726952|NCT00372424|Secondary|Plasma Trough Concentrations (Ctrough) of Trastuzumab|Ctrough = the concentration prior to study medication administration.|Weekly trastuzumab: Pre-dose (0 H) on Day 1 and 15 of Cycle 1, 2, 4 and 6; 3-weekly trastuzumab: Pre-dose (0 H) on Day 1 of Cycle 1, 2, 4 and 6|Data was not summarized since majority of observed Ctrough values were below lower limit of quantification.|||||
726953|NCT00372424|Secondary|Maximum Observed Plasma Concentration (Cmax) of Docetaxel|Concentration values below the lower limit of quantification were taken as zero.|End of infusion (1 H) on Day 1 of Cycle 1, 2, 4 and 6|PK analysis set included participants from study population who had completed sampling for pharmacokinetic profiles for study medication. 'n' is number of participants who were evaluable at given time points.||ng/mL||Standard Deviation|Mean
726954|NCT00372424|Secondary|Plasma Trough Concentrations (Ctrough) of SU011248 (Sunitinib), SU012662 (Sunitinib Metabolite) and Total Drug (SU011248+SU012662)|Ctrough = the concentration prior to study medication administration. Ctrough was calculated for SU011248 (Sunitinib), SU012662 (Sunitinib metabolite) and total drug (SU011248+SU012662). Concentration values below the lower limit of quantification were taken as zero.|Pre-dose (0 hours [H]) on Day 1 and Day 15 of Cycle 2, 4, 6 and additionally Day 15 of Cycle 1|Pharmacokinetic (PK) analysis set included participants from study population who had completed sampling for pharmacokinetic profiles for study medication. 'n' is number of participants who were evaluable at given time points.||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
726955|NCT00372424|Secondary|Duration of Response (DR)|Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Baseline, assessed every 6 weeks starting from Day1 of Cycle 3 up to end of treatment (Day 1344)|Study population, subgroup of participants with a confirmed objective tumor response (CR or PR).||weeks||95% Confidence Interval|Median
726956|NCT00372424|Secondary|Progression-free Survival (PFS)|"Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Baseline, assessed every 6 weeks starting from Day1 of Cycle 3 up to end of treatment (Day 1344)|Study population included all participants who received at least 1 dose of study medication.||weeks||95% Confidence Interval|Median
726957|NCT00372424|Secondary|Percentage of Participants With Objective Response (OR)|Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as disappearance of all target lesions. PR are those with at least 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Baseline, assessed every 6 weeks starting from Day1 of Cycle 3 up to end of treatment (Day 1344)|Per protocol (PP) population included all participants who received at least 1 dose of sunitinib and had at least a tumor assessment post baseline.||percentage of participants||95% Confidence Interval|Number
726958|NCT00372424|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|From screening until 28 days post last dose of study drug|Safety population included all participants enrolled in the study who received at least 1 dose of study medication.||participants|||Number
726959|NCT00372489|Primary|Proportion of Participants With Mean Hemoglobin in the Target Range of 10.0-12.0 Grams Per Deciliter (g/dL) After Dosing Guideline Change||Up to 54 months|Full Analysis - Number of participants with hemoglobin assessed after dosing guideline change||percentage of participants|||Number
726960|NCT00372528|Secondary|Mean Number of Seizures|Seizures were episodes of disturbed brain activity that cause changes in attention or behavior. The different types of seizures observed were complex partial, secondarily generalized tonic-clonic, simple partial and others. Mean number of seizures were calculated between each study visit.|Month 6 thereafter every 6 months up to Month 54 or End of Study (EOS) and follow-up (30 days after last dose)|SAS included all participants who had received at least 1 dose of study medication in the open label period. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here, 'n' signifies those participants who were evaluable between each visit.||Seizures||Standard Deviation|Mean
726961|NCT00372528|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to Year 5 and follow-up (30 days after last dose)|Safety Analysis Set (SAS) included all participants who had received at least 1 dose of study medication in the open label period.||Participants|||Number
726962|NCT00372567|Secondary|Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Imatinib Treatment Arm|EQ-5D: participant rated questionnaire assessed health-related quality of life in terms of a single index value. The VAS component rated current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicated a better health state.|Days 1 and 28 of each cycle|ITT; Number of participants analyzed: participants who completed the scale; n: participants who completed the scale at the respective cycle.||Scores on a scale||Standard Deviation|Mean
726963|NCT00372567|Secondary|Euro Quality of Life (EQ-5D) - Health State Profile Utility Score - Imatinib Treatment Arm|"EQ-5D: participant rated questionnaire assessed health-related quality of life in terms of a single utility score. Health State Profile component rated current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicated better health state (no problems); 3 indicated worst health state (eg, confined to bed). Scoring formula developed by EuroQol Group assigned utility value for each domain in the profile. Score was transformed and results in a total score ranged 0.21 to 1.000; higher score indicated a better health state."|Days 1 and 28 of each cycle|ITT; Number of participants analyzed: participants who completed the scale; n: participants who completed the scale at the respective cycle.||Scores on a scale||Standard Deviation|Mean
726964|NCT00372567|Secondary|Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Sunitinib Treatment Arm|EQ-5D: participant rated questionnaire assessed health-related quality of life in terms of a single index value. The VAS component rated current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicated a better health state.|Days 1 and 28 of each cycle|ITT; Number of participants analyzed: participants who completed the scale; n: participants who completed the scale at the respective cycle.||Scores on a Scale||Standard Deviation|Mean
728440|NCT00380250|Secondary|Month 3 Stool Consistency Change From Baseline|0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)|Change from baseline for month 3|ITT with LOCF||Scale score||Standard Deviation|Mean
726965|NCT00372567|Secondary|Euro Quality of Life (EQ-5D) - Health State Profile Utility Score- Sunitinib Treatment Arm|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component rated current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicated better health state (no problems); 3 indicated worst health state (eg, confined to bed). Scoring formula developed by EuroQol Group assigned utility value for each domain in profile. Score was transformed and results in a total score ranged 0.21 to 1.000; higher score indicated a better health state."|Days 1 and 28 of each cycle|ITT; Number of participants analyzed: participants who completed the scale; n: participants who completed the scale at the respective cycle.||Scores on a scale||Standard Deviation|Mean
726966|NCT00372567|Secondary|Number of Participants With Pain Progression|Pain progression defined as a 50% or more increase in MPQ-PPI score (0=no pain to 5=excruciating pain) or analgesic use from baseline for at least 3 consecutive weeks. Analgesic use scores were based on 1 point per non narcotic dose of medication and 4 points per dose of narcotic medication.|Day 28 of Cycle 1 up to 26|ITT; Number of participants analyzed: participants with MPQ-PPI and analgesic use data at baseline.||Participants|||Number
726967|NCT00372567|Secondary|Number of Participants With Pain Relief Response|Pain relief response defined as a 50% or more reduction in the McGill Pain Questionaire - Present Pain Intensity (MPQ-PPI) score (0=no pain to 5=excruciating pain) and/or analgesic use from baseline for at least 3 consecutive weeks. Analgesic use scores were based on 1 point per non narcotic dose of medication and 4 points per dose of narcotic medication.|Day 28 of Cycle 1 up to 26|ITT; Number of participants analyzed: participants with MPQ-PPI and analgesic use data at baseline.||Participants|||Number
726968|NCT00372567|Secondary|Time to Pain Progression (TTPP)|TTPP is the number of days from randomization to the first documentation of pain progression (defined as a 50% or more increase in MPQ-PPI score [0=no pain to 5=excruciating pain] or analgesic use from baseline for at least 3 consecutive weeks). Analgesic use scores were based on 1 point per non narcotic dose of medication and 4 points per dose of narcotic medication.|Day 28 of Cycle 1 up to 26|ITT; Number of participants analyzed: participants with an event.||Days||95% Confidence Interval|Median
726969|NCT00372567|Secondary|Duration of Response (DR)|"Time from start of first documentation of objective response(complete or partial response) that was subsequently confirmed to first documentation of objective tumor progression or death due to any cause, whichever occurred first.
Confirmed complete response (CR) and partial response (PR)according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as the disappearance of all target lesions. PR was defined as a greater than or equal to 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions."|Day 28 of Cycle 1 up to 26|ITT; Number of participants analyzed: participants with an objective tumor response. DR data censored on the day following the date of the last tumor assessment on study for participants who did not have objective tumor progression and who did not die due to any cause while on study.||Weeks||Full Range|Median
726970|NCT00372567|Secondary|Time to Tumor Response (TTR)|Time from date of randomization to first documentation of objective tumor response (partial or complete response). Confirmed complete response (CR) and partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as the disappearance of all target lesions. PR was defined as a greater than or equal to 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Day 28 of Cycle 1 up to 26|ITT||Weeks||95% Confidence Interval|Median
726971|NCT00372567|Secondary|Number of Participants With Objective Response of Complete Response or Partial Response|Number of participants with objective response based assessment of confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as the disappearance of all target lesions. PR was defined as a greater than or equal to 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Day 28 of Cycle 1 up to 26|ITT||Participants|||Number
726972|NCT00372567|Secondary|Time to Treatment Failure (TTF)|TTF included death for any reason, treatment termination due to intolerable toxicity, or withdrawal of consent, whichever occurred first.|Day 28 of Cycle 1 up to 26|ITT; Number of participants analyzed: participants with treatment failure.||Months||95% Confidence Interval|Median
726973|NCT00372567|Secondary|Time to Pain Relief Response (TTPR)|Pain relief response defined as a 50 percent (%) or more reduction in the McGill Pain Questionaire - Present Pain Intensity (MPQ-PPI) score (0=no pain to 5=excruciating pain) and/or analgesic use from baseline for at least 3 consecutive weeks. Analgesic use scores were based on 1 point per non narcotic dose of medication and 4 points per dose of narcotic medication.|Day 28 of Cycle 1 up to 26|ITT||Days||95% Confidence Interval|Median
726974|NCT00372567|Secondary|Overall Survival (OS)|Time from date of randomization to the date of death. In the absence of confirmation of death, survival time was censored to the last date the participant was known to be alive.|Baseline up to 2 years|ITT||Months||95% Confidence Interval|Median
726975|NCT00372567|Primary|Progression-Free Survival (PFS)|Time from randomization to the first documentation of tumor progression or death due to any cause in the absence of documented tumor progression, whichever was earlier.|Baseline, Week 5, and every 8 weeks until Year 2|Intention to treat (ITT): all participants in Main Study (Phase 3) who were randomized, regardless of whether the participant received any drug or received a different drug from that to which they were randomized. Number of participants analyzed: participants who had a PFS event (progressive disease or death).||Months||95% Confidence Interval|Median
726976|NCT00372593|Secondary|Toxicities, Including Infectious Complications|Number of participants with at least one grade 3 or higher adverse event during therapy.|From the time therapy is initiated, assessed up to 10 years|Ineligible (n=42) patients are excluded.||Number of participants|||Number
726977|NCT00372593|Secondary|Time to Marrow Recovery|Mean time to ANC recovery - defined as ANC greater than 500/MicroLiter for 3 consecutive days.|At 25 days after treatment with Induction I, Induction II, and Intensification I|Excluded: Ineligible patients (pts) (n=42) for overall number of pts analyzed. For Induction I: Pts who did not have ANC recovery (n=237) or w/unknown (w/unk) status (n=14). For Induction II: Pts who did not have ANC recovery (n=142) or w/unk status (n=82). For Intensification I: Pts who did not have ANC recovery (n=104) or w/unk status (n=182)||Mean days||Standard Deviation|Mean
726978|NCT00372593|Secondary|Mortality|Number of participants who died during the first three courses of therapy.|During the first three courses of therapy|Ineligible (n=42) patients are excluded.||Number of participants|||Number
726980|NCT00372593|Secondary|Remission Induction Rate After 2 Courses of Induction Therapy|Patients without an evaluable bone marrow at the end of Induction I will be excluded from the calculation of remission rate after 2 courses of therapy because their responses are not evaluable. The following patients will be considered to not be in complete remission (CR) after 2 courses of therapy: (1) patients who die during Induction I and II; (2) patients with ≥ 5% blasts or extramedullary disease at the end of Induction II.|After 2 courses of induction (I and II) therapy, assessed for up to 10 years|Ineligible (n=42) patients are excluded. Patients without an evaluable bone marrow at the end of Induction I or at the end of Induction II are excluded from the calculation of remission rate after 2 courses of therapy because their responses are not evaluable (n=45).||Proportion of participants|||Number
726981|NCT00372593|Primary|Overall Survival at 3 Years|The Kaplan-Meier method will be used to calculate estimates of OS. Analysis of OS of Down syndrome patients will be performed separately. Monitoring for efficacy of GMTZ with respect to OS and EFS will utilize monitoring based on the Lan-DeMets criterion with α-spending function αt^2 (truncated at 3 standard deviations) and 2.5% type I error.|Time from study entry, assessed at 3 years|Ineligible patients are excluded from analyses of Overall Survival and Event Free Survival.||percentage of participants||95% Confidence Interval|Number
726982|NCT00372593|Primary|Event-free Survival at 3 Years|The Kaplan-Meier method will be used to calculate estimates of Event Free Survival (EFS). The log-rank test will be used to compare survival between treatment groups. Analysis of EFS of Down syndrome patients will be performed separately. Monitoring for efficacy of GMTZ with respect to Overall Survival (OS) and EFS will utilize monitoring based on the Lan-DeMets criterion with α-spending function αt^2 (truncated at 3 standard deviations) and 2.5% type I error.|Time from study entry to time of induction failure, relapse, or death, assessed at 3 years|Ineligible patients are excluded from analyses of Overall Survival and Event Free Survival.||percentage of participants||95% Confidence Interval|Number
726983|NCT00372619|Secondary|Correlate the Expression of Apoptosis Specific Genes|Correlate the expression of apoptosis specific genes with chemoresistance and determine whether therapy with clofarabine is able to overcome blocks in apoptosis through modulation of gene expression. Gene expression analysis will be performed on specimens obtained during therapy. Apoptosis specific microarray data will be analyzed using GeneTraffic software (Iobion Informatics, La Jolla CA).|End of therapy|The analysis was not completed, because the tissue microarray was unsuccessful.|||||
726984|NCT00372619|Secondary|Safety and Tolerability as Measured by CTCAE v3.0|Number of participants with at least one grade 3 or higher adverse event during therapy.|End of therapy|Ineligible (n=2) and inevaluable (n=1) patients are excluded||number participants|||Number
726985|NCT00372619|Primary|Overall Response (CR for ALL Patients), (CR + CRp for AML Patients)|"Overall response for ALL patients: CR - complete remission (attainment of an M1 bone marrow (< 5% blasts) with no evidence of circulating blasts or extramedullary disease and with recovery of peripheral counts (absolute neutrophil count (ANC) > 750/μL and platelet count > 75,000/μL).
Overall response for AML patients: (CR + CRp), defined as:
CR - complete remission (attainment of an M1 bone marrow (<5% blasts) with no evidence of circulating blasts or extramedullary disease and with recovery of peripheral blood counts (absolute neutrophil count (ANC) > 1000/uL and platelet count > 100,000/uL)) or CRp - remission without platelet recovery (Attainment of an M1 bone marrow (<5% blasts) with no evidence of circulating blasts or extramedullary disease and with recovery of absolute neutrophil count (ANC) > 1000/uL and platelet transfusion independence (defined as: no platelet transfusions x 1 week))."|2 cycles or up to 84 days|||participants|||Number
726986|NCT00372697|Secondary|Acromegaly Quality of Life (AcroQoL) Questionnaire Psychological Scale Score at End of Study (Week 24)|The AcroQoL contains 14 items on Psychological aspects. Participants were asked to rate each item on a 1-5 Likert scale measuring either the frequency of occurrence (always, most of the time, sometimes, rarely, or never) or the degree of agreement (completely agree, moderately agree, neither agree nor disagree, moderately disagree, completely disagree). The score on the psychological scale ranges from 14-70. A higher score indicates better Quality of Life.|End of study (Week 24)|Intent-to-treat (ITT) population included all enrolled participants who received at least 1 dose of assigned study medication and who had data for this outcome measure.||Percent of maximum score||Standard Deviation|Mean
726987|NCT00372697|Secondary|Acromegaly Quality of Life (AcroQoL) Questionnaire Physical Scale Score at End of Study (Week 24)|The AcroQoL contains 8 items on Physical aspects. Participants were asked to rate each item on a 1-5 Likert scale measuring either the frequency of occurrence (always, most of the time, sometimes, rarely, or never) or the degree of agreement (completely agree, moderately agree, neither agree nor disagree, moderately disagree, completely disagree). The score on the physical scale can range from 8-40. A higher score indicates better Quality of Life.|End of study (Week 24)|Intent-to-treat (ITT) population included all enrolled participants who received at least 1 dose of assigned study medication.||Percent of maximum score||Standard Deviation|Mean
726988|NCT00372697|Secondary|Percentage of Participants Asymptomatic for Acromegaly Symptoms at Week 12 and End of Study (Week 24)|The investigator asked the participant to score the following symptoms of acromegaly: Headache, perspiration, paresthesia, fatigue, osteoarthralgia, and carpal tunnel syndrome on a 5-point scale (0=absent; 1=mild; 2=moderate; 3=severe, but not disabling; 4=severe and disabling). The percentage of asymptomatic participants, ie, with a score of 0 for all symptoms, was calculated.|Week 12 and end of study (Week 24)|Intent-to-treat (ITT) population included all enrolled participants who received at least 1 dose of assigned study medication.||Percentage of participants|||Number
726989|NCT00372697|Secondary|Percentage of Participants With > 20% Tumor Shrinkage From Screening to End of Study (Week 24)|A pre-treatment magnetic resonance image (MRI) assessment of the pituitary area was required within 12 weeks prior to Screening as a baseline evaluation. A second MRI was performed at the end of the study (Week 24). All MRIs were performed according to protocol-defined guidelines. The tumor volume (mm^3) was calculated from measurements obtained in 3 axes from the MRI images.|Screening to end of study (Week 24)|Intent-to-treat (ITT) population included all enrolled participants who received at least 1 dose of assigned study medication and who had data for this outcome measure.||Percentage of participants|||Number
727004|NCT00372775|Secondary|Number of Participants With Intracranial Objective Disease Response|Intracranial objective disease response defined as participants with confirmed CR or PR, according to WHO criteria. CR defined as disappearance of all enhancing tumor. PR defined as a ≥50% reduction from baseline in sum of the products of all enhancing tumors.|Baseline and Day 1 of Week 5, 9, 17, 25, 33, 41, and 49|ITT with measurable intracranial disease at baseline.||Participants|||Number
726990|NCT00372697|Secondary|Change in Tumor Volume From Screening to End of Study (Week 24)|A pre-treatment magnetic resonance image (MRI) assessment of the pituitary area was required within 12 weeks prior to Screening as a baseline evaluation. A second MRI was performed at the end of the study (Week 24). All MRIs were performed according to protocol-defined guidelines. The tumor volume (mm^3) was calculated from measurements obtained in 3 axes from the MRI images.|Screening to end of study (Week 24)|Intent-to-treat (ITT) population included all enrolled participants who received at least 1 dose of assigned study medication and who had data for this outcome measure.||mm^3||Standard Deviation|Mean
726991|NCT00372697|Primary|Change in Insulin-like Growth Factor 1 (IGF-1) Level From Screening to End of Study (Week 24)|Insulin-like growth factor 1 (IGF-1) level was measured in a blood sample with an automated immunometric assay in a central laboratory.|Screening to end of study (Week 24)|Intent-to-treat (ITT) population included all participants who received at least one dose of study medication and who had at least one post-baseline evaluation of the primary variable.||µg/L||Standard Deviation|Mean
726992|NCT00372697|Primary|Change in Growth Hormone (GH) Level From Screening to End of Study (Week 24)|Growth hormone (GH) level was the average value measured in 3 blood samples collected at 15 minute intervals at each visit. GH was measured with an automated immunometric assay in a central laboratory.|Screening to end of study (Week 24)|Intent-to-treat (ITT) population included all participants who received at least one dose of study medication and who had at least one post-baseline evaluation of the primary variable.||µg/L||Standard Deviation|Mean
726993|NCT00372775|Secondary|PFS in Subgroups Defined by RNA Expression Profiles of Tumors|PFS defined as time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was to be determined in subgroups defined by RNA Gene expression (CSF-1R, PDGFRalpha, PDGFRbeta, VEGF, VEGF-C, VEGFR1, VEGFR2, VEGFR3, FGF, FLT3, KIT, and RET) level (low/high relative to expression of Glyceraldehyde-3-Phosphate Dehydrogenase [GAPDH] reference gene). PFS calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7.02.|Day 1 of Week 1 and every 4 weeks up to 1 year|ITT. Only 4 RNA samples were collected and no statistical analyses performed.||weeks||90% Confidence Interval|Median
726994|NCT00372775|Secondary|Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile|Tumor samples were not anonymized. RNA expression profile was to include colony-stimulating factor 1 receptor (CSF-1R), platelet-derived growth factor receptor alpha and beta (PDGFRalpha and PDGFRbeta), vascular endothelial growth factor (VEGF), VEGF-C, VEGF receptor 1, 2, and 3 (VEGFR1, VEGFR2, and VEGFR3), fibroblast growth factor (FGF), FMS-like tyrosine kinase 3 (FLT3), KIT (stem cell factor receptor), and RET (rearranged during transfection).|Day 1 of Week 1 and every 4 weeks up to 1 year|ITT. Only 4 RNA samples were collected and no statistical analyses performed.||Percentage of participants|||Number
726995|NCT00372775|Secondary|Correlation of Polymorphisms in c-Kit, Flt-3 and c-Fms With Blood Counts|A blood sample (6mL) collected before treatment with Sunitinib and used to isolate deoxyribonucleic acid (DNA). These samples were not anonymized.|Day 1 prior to dosing|ITT. c-Kit, Flt-3 and c-Fms with blood count samples collected; however, no statistical analyses performed since power was insufficient.||picograms per milliliter (pg/mL)|||Number
726996|NCT00372775|Secondary|Ctrough of Sunitinib Metabolite (SU012662)|A single blood sample (4 mL) collected pre-dose on Day 1 of Cycles 2, 3, and 4 to determine Ctrough of Sunitinib and its metabolite SU12662. Each cycle = 28 days. Ctrough defined as plasma concentration prior to study drug administration. Trough plasma concentrations were dose-corrected.|Day 1 of Week 5, 9, and 13|ITT participants who had pharmacokinetic results for at least 1 day. Ctrough only calculated for subgroup of participants with observations (non-missing concentrations). n = number of participants with evaluable data.||ng/mL||Standard Deviation|Mean
726997|NCT00372775|Secondary|Trough Plasma Concentrations (Ctrough) of Sunitinib|A single blood sample (4 milliliters [mL]) collected pre-dose on Day 1 of Cycles 2, 3, and 4 to determine Ctrough of Sunitinib and its metabolite SU12662. Each cycle = 28 days. Ctrough defined as plasma concentration prior to study drug administration. Trough plasma concentrations were dose-corrected.|Day 1 of Week 5, 9, and 13|ITT participants who had pharmacokinetic results for at least 1 day. Ctrough only calculated for subgroup of participants with observations (non-missing concentrations). n = number of participants with evaluable data.||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
726998|NCT00372775|Secondary|Change From Baseline in FACT/NCCN Brain Symptom Index (FBrSI) Score|Change from baseline in FBrSI Score was calculated Day 1 of Cycle 2 to 13. Each cycle = 28 days. Scores ranged from 0 to 60. Higher scores indicated better outcomes.|Baseline, Day 1 of Week 5 and every 4 weeks to end of treatment (up to 1 year)|ITT population of participants with post baseline patient-reported outcome data||Scores on a scale||95% Confidence Interval|Mean
726999|NCT00372775|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy/National Comprehensive Cancer Network (FACT/NCCN) Lung Symptom Index (FLSI) Score|Change from baseline in FLSI Score was calculated Day 1 of Cycle 2 to 13. Each cycle = 28 days. Scores ranged from 0 to 24. Higher scores indicated better outcomes.|Baseline, Day 1 of Week 5 and every 4 weeks to end of treatment (up to 1 year)|ITT population of participants with post baseline patient-reported outcome data||Scores on a scale||95% Confidence Interval|Mean
727000|NCT00372775|Secondary|Number of Deaths Due to Intracranial Versus Systemic Progression|Number of deaths determined to be intracranial versus systemic progression, according to investigators’assessment.|Baseline until death (up to 1 year)|ITT||Participants|||Number
727001|NCT00372775|Secondary|Percentage of Participants Surviving at 1 Year|Percentage of those surviving at end of 1 year from the first dose of study treatment.|Year 1|ITT||Percentage of participants|||Number
727002|NCT00372775|Secondary|Overall Survival (OS)|OS calculated as: (date of death minus date of first dose plus 1)divided by 30.4.|Baseline until death (up to 1 year)|ITT. In the absence of confirmation of death, survival time was censored to last date of known contact.||Months||95% Confidence Interval|Median
727003|NCT00372775|Secondary|Duration of Response (DR)|DR defined as difference in weeks between first date criteria for progression occurred, or participant died due to any cause and first date that criteria for a PR or CR were met and subsequently confirmed ≥4 weeks later. Since day criteria for PR or CR were met and first day criteria for progression occurred (or participant died) were each counted as a full day, 1 day was added to each calculation. DR (in weeks) calculated as (first date of PD or death minus first date of CR or PR that was subsequently confirmed plus 1) divided by 7.02.|Day 7 of Week 4 and every 4 weeks up to 1 year|ITT. DR only calculated for the subgroup of participants with an objective tumor response.||Weeks|||Number
727005|NCT00372775|Secondary|Time to Objective Intracranial Progression|Time in weeks from start of study treatment to first documentation of objective intracranial tumor progression. Intracranial tumor progression defined as ≥25% increase from smallest size in sum of products of all enhancing tumors or appearance of any new tumor, according to World Health Organization (WHO) criteria. Since day of first dose of medication and day criteria for progression were met, were each counted as a full day, 1 day added to each calculation. Time to Objective Intracranial Progression = (first event date minus the date of first dose of study medication plus 1) divided by 7.02.|Baseline, Day 1 of Week 5, 9, 17, 25, 33, and 41 to intracranial tumor progression (up to 1 year)|ITT||Weeks||95% Confidence Interval|Median
727006|NCT00372775|Secondary|Number of Participants With Objective Disease Response|Objective disease response defined as participants with confirmed complete response (CR) or partial response (PR), according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as disappearance of all target lesions. PR defined as ≥30% decrease in sum of longest dimensions of target lesions taking as a reference the baseline sum longest dimensions.|Baseline and Day 1 of Week 5, 9, 17, 25, 33, 41, and 49|ITT with measurable disease at baseline.||Participants|||Number
727007|NCT00372775|Secondary|Time to Neurological Progression (TNP)|Time in weeks between first date criteria for focal neurological deficit were met and date of first dose of medication. Criteria for focal neurological deficit included speech or language difficulties, vision changes, loss of coordination or fine motor control, and seizures. Since day of first dose of medication and day criteria for focal neurological deficit were met were each counted as a full day, 1 day was added to each calculation. TNP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7.02.|Baseline, Day 28 to focal neurological deficit (up to 1 year)|ITT||Weeks||Full Range|Median
727008|NCT00372775|Secondary|Time to Tumor Progression (TTP)|Time from start of study treatment to first documentation of objective tumor progression. Tumor progression defined as greater than or equal to 20 percent (≥20%) increase in sum of longest dimensions of target lesions using as reference smallest sum of longest dimensions recorded since treatment started, or unequivocal progression of existing non-target lesions, or appearance of ≥1 new lesion, according to Response Evaluation Criteria in Solid Tumors (RECIST). TTP = (first event date minus date of first dose of study medication plus 1) divided by 7.02.|Baseline, Day 1 of Week 5, 9, 17, 25, 33, and 41 to tumor progression (up to 1 year)|ITT||Weeks||95% Confidence Interval|Median
727009|NCT00372775|Primary|Progression-Free Survival (PFS)|Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. Since day of first dose of medication and day criteria for progression were met, were each counted as a full day, 1 day was added to each calculation. PFS calculated as (first event date minus date of first dose of study medication plus 1) divided by 7.02. Used 7.02 days because it equals(=) 365 days per year divided by 52 weeks per year. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]).|Baseline, Day 1 of Week 5, 9, 17, 25, 33, and 41 to tumor progression or death (up to 1 year)|Intent-to-treat (ITT): all participants enrolled in the study who received at least 1 dose of study medication.||Weeks||90% Confidence Interval|Median
727010|NCT00372970|Primary|Symptom Response as Assessed by the Gastroparesis Cardinal Symptom Index.|"Scale for GI symptoms related to gastroparesis. For this we will use the gastroparesis cardinal symptom index (GCSI).
The GCSI is based on three subscales: post-prandial fullness/early satiety (4 items); nausea/vomiting (3 items), and bloating (2 items). Scores range from 0-5 for the nine items and an asymptomatic patient would have a score of 0 with a highly symptomatic patient having a score of 45. For this study the score had to be >=27. In a previous study internal consistency reliability was 0.84 for the GCSI total score and ranged from 0.83 to 0.85 for the subscale scores. Two week test retest reliability was 0.76 for the total score and ranged from 0.68 to 0.81 for subscale scores."|1 month|All patients had gastroparesis and underwent EGD. Injection double blinded.||units on a scale||Standard Deviation|Mean
727011|NCT00372996|Secondary|EORTC QLQ Breast Cancer Module (BR23) Scores|EORTC-QLQ-BR23: included functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions used 4-point Likert scale (1 â€˜Not at Allâ€™ to 4 â€˜Very Muchâ€™). Scores averaged and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems. Change from baseline=Cycle/Day score minus baseline score.|Predose on Day 1, at end of treatment, and at Follow-up, up to 60 months|The study was terminated early secondary to strategic reasons and the questionnaires were discontinued by Protocol Amendment 6. Therefore, the analysis was not performed and an incomplete data set was not reported because it would potentially skew the data, and is not statistically relevant, thus could be misleading.|||||
727012|NCT00372996|Secondary|European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 (QLQ-C30) Scores|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score equals (=) better level of functioning or greater degree of symptoms.|Predose on Day 1 of each cycle, at the end of treatment and at follow-up, up to 60 months|The study was terminated early secondary to strategic reasons and the questionnaires were discontinued by Protocol Amendment 6. Therefore, the analysis was not performed and an incomplete data set was not reported because it would potentially skew the data, and is not statistically relevant, thus could be misleading.|||||
727013|NCT00372996|Secondary|Percentage of Participants With Serum Markers Relevant to the IGF-1R Pathway||Predose on Day 1 of Cycles 1 and 4 and at end of treatment prior to beginning salvage therapy|The study was terminated early due to strategic reasons and biomarker sampling was discontinued by Protocol Amendment 6. Therefore, the analysis was not performed and an incomplete data set was not reported because it would potentially skew the data, and is not statistically relevant, thus could be misleading.|||||
727014|NCT00372996|Secondary|Percentage of Participants With Circulating Tumor Cells Expressing Insulin-Like Growth Factor 1 Receptor (IGF-IR)||Predose on Day 1 of Cycle 1|The study was terminated early due to strategic reasons and biomarker sampling was discontinued by Protocol Amendment 6. Therefore, the analysis was not performed and an incomplete data set was not reported because it would potentially skew the data, and is not statistically relevant, thus could be misleading.|||||
727015|NCT00372996|Secondary|Number of Participants With Negative Human Anti-Human Antibodies (HAHAs)|Negative human anti-human antibodies were defined as <6.64|Predose on Day 1 of Cycle 1 and at 150 days post last CP-751,871 infusion|All randomized participants who started treatment and who had at least 1 sample submitted for the biomarker; collection of samples for this analysis was stopped after Amendment 6. All samples were negative to HAHA.||participants|Participants||Number
727016|NCT00372996|Secondary|Area Under the Concentration Time Curve From Time 0 to the Last Time Point With Quantifiable Concentration||Predose on Day 1 at Cycles 1, 2, 4, and 5 and 150 days post last dose of CP-751,871 and for salvage therapy, at Day 1 and 150 days post last dose of CP-751,871|The study was terminated early due to strategic reasons and PK sampling was discontinued by Protocol Amendment 6. Therefore, the analysis was not performed and an incomplete data set was not reported because it would potentially skew the data, and is not statistically relevant, thus could be misleading.|||||
727017|NCT00372996|Secondary|Minimum Plasma Concentration of CP-751,871||Predose on Day 1 at Cycles 1, 2, 4, and 5 and 150 days post last dose of CP-751,871 and for salvage therapy, at Day 1 and 150 days post last dose of CP-751,871|The study was terminated early due to strategic reasons and PK sampling was discontinued by Protocol Amendment 6. Therefore, the analysis was not performed and an incomplete data set was not reported because it would potentially skew the data, and is not statistically relevant, thus could be misleading.|||||
727018|NCT00372996|Secondary|Maximum Plasma Concentration of CP-751,871||Predose on Day 1 at Cycles 1, 2, 4, and 5 and 150 days post last dose of CP-751,871 and for salvage therapy, at Day 1 and 150 days post last dose of CP-751,871|The study was terminated early due to strategic reasons and pharmacokinetic (PK) sampling was discontinued by Protocol Amendment 6. Therefore, the analysis was not performed and an incomplete data set was not reported because it would potentially skew the data, and is not statistically relevant, thus could be misleading.|||||
727019|NCT00372996|Secondary|Percentage of Participants Achieving Complete Response (CR), Partial Response (PR), or Stable Disease (SD) Maintained for at Least 6 Months|Objective responses were defined using RECIST as CR: disappearance of all target and nontarget lesions. PR: at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as a reference the baseline sum LD. Nontarget lesions may persist provided there is no unequivocal progression in these lesions. SD: measurements demonstrating neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify as progressive disease (PD) during the first 6 weeks after the start of treatment taking as reference the smallest sum LD since the treatment started. During this time, nontarget lesions may persist provided there is no unequivocal progression in these lesions.|Baseline, Day 1 of Cycles 2 and 4 and then Day 1 of every 3rd cycle starting at Cycle 7 up to 60 months|FAS||percentage of participants||95% Confidence Interval|Number
727020|NCT00372996|Primary|PFS in Participants With Hemoglobin A1c (HbA1c) Less Than (<) 5.7% at Baseline|PFS was calculated from the time of randomization to either progression of disease, death, or treatment discontinuation because of unsatisfactory therapy results (such as global deterioration of health status). Disease progression was defined as 1 or more of the following: radiographic progression (20% increase in measurable lesions, appearance of new lesions or unequivocal progression of evaluable lesions as defined by RECIST); occurrence of new pleural/pericardial effusions or ascites confirmed by positive cytology; persistent hypercalcemia requiring more than 2 IV treatments with bisphosphonates; intervention for any cancer-related events (radiations, surgery) or new symptoms related to tumor growth requiring participant discontinuation; development of brain metastasis; or death for any cause. Median PFS was estimated from the Kaplan-Meier curve. 95% CI is based on the Brookmeyer and Crowley method.|Baseline, Day 1 of Cycles 2 and 4 and then Day 1 of every 3rd cycle starting at Cycle 7 up to 60 months|FAS; only participants with baseline HbA1c <5.7% were included in the analysis.||months||95% Confidence Interval|Median
727021|NCT00372996|Primary|Progression-Free Survival (PFS)|PFS was calculated from the time of randomization to either progression of disease, death, or treatment discontinuation because of unsatisfactory therapy results (such as global deterioration of health status). Disease progression was defined as 1 or more of the following: radiographic progression (20 percent [%] increase in measurable lesions, appearance of new lesions or unequivocal progression of evaluable lesions as defined by Response Evaluation Criteria in Solid Tumors [RECIST]); occurrence of new pleural/pericardial effusions or ascites confirmed by positive cytology; persistent hypercalcemia requiring more than 2 IV treatments with bisphosphonates; intervention for any cancer-related events (radiations, surgery) or new symptoms related to tumor growth requiring participant discontinuation; development of brain metastasis; or death for any cause. Median PFS was estimated from the Kaplan-Meier curve. 95% confidence interval (CI) is based on the Brookmeyer and Crowley method.|Baseline, Day 1 of Cycles 2 and 4 and then Day 1 of every 3rd cycle starting at Cycle 7 up to 60 months|Full Analysis Set (FAS): all enrolled participants; grouped by randomized arm, where the first 10 participants enrolled but not randomly assigned to treatment were not included.||months||95% Confidence Interval|Median
727022|NCT00373113|Secondary|EORTC QLQ Breast Cancer Module (BR23)|"BR23: measured disease related symptoms of dry mouth, eye pain, hair loss, hot flushes, attractiveness, future health, sexual activity, arm/shoulder pain, breast pain, swollen breast, and skin problems on the breast. Recall period: past week; response range: not at all to very much.
Scale score range: 0 to 100. Higher symptom score implied a greater degree of symptoms."|From Day 1 of Cycle 1, then odd numbered cycles thereafter|The study was stopped early for futility and EORTC QLQ Cancer Module (BR23) analysis was not performed.||scores on a scale||Standard Deviation|Mean
727023|NCT00373113|Secondary|European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30)|"EORTC QLQ-C30 scales: functional (physical/role/cognitive/emotional/social), symptom (fatigue/nausea/vomiting/pain), global health/QOL, cancer symptom (dyspnea/insomnia/appetite loss/constipation/diarrhea).
Feelings in past week: response range: not at all to very much, global/QOL range: very poor to excellent. Scales/single-items averaged, score 0 to 100. Higher functional/global=better functioning and symptom=greater degree of symptoms."|From Day 1 of Cycle 1, then odd numbered cycles thereafter|The study was stopped early for futility and EORTC QLQ-C30 analysis was not performed.||scores on a scale||Standard Deviation|Mean
727024|NCT00373113|Secondary|Overall Survival (OS)|Average time from randomization to first documentation of death due to any cause.|From time of randomization until death|ITT population||Months||95% Confidence Interval|Median
728441|NCT00380250|Secondary|Month 2 Stool Consistency Change From Baseline|0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)|Change from baseline for month 2|ITT with LOCF||Scale score||Standard Deviation|Mean
727025|NCT00373113|Secondary|Time to Tumor Response (TTR)|Time from randomization to the first documentation of objective tumor response (CR or PR) that was subsequently confirmed. CR was defined as disappearance of all target lesions. PR was defined as a >= 30% decrease in sum of longest dimensions of target lesions taking as a reference baseline sum longest dimensions.|From time of randomization to every 6 weeks thereafter through 22 months|The study was stopped early for futility and TTR analysis was not performed.||Months||95% Confidence Interval|Median
727026|NCT00373113|Secondary|Duration of Response (DR)|Time from the first documentation of OR (CR or PR) that was subsequently confirmed to the first documentation of tumor progression or death due to any cause. CR was defined as disappearance of all target lesions. PR was defined as a >= 30% decrease in sum of longest dimensions of target lesions taking as a reference baseline sum longest dimensions.|From time of randomization to every 6 weeks thereafter through 22 months or death|ITT population. DR was calculated for the subgroup of participants with objective response. 27 participants in the sunitinib arm and 40 participants in the capecitabine arm reported CR or PR response and were analyzed for DR.||Months||95% Confidence Interval|Median
727027|NCT00373113|Secondary|Number of Participants With Overall Response (OR)|OR was defined as the number of participants with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST, Version 1.0) for at least 4 weeks, confirmed by repeat tumor assessments. CR was defined as the disappearance of all target lesions. PR was defined as a greater than or equal to (>=) 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|From time of randomization to every 6 weeks thereafter through 22 months|ITT population||Participants|||Number
727028|NCT00373113|Secondary|Time to Tumor Progression (TTP)|Time from randomization to first documentation of objective tumor progression.|From time of randomization to every 6 weeks thereafter through 22 months|ITT population||Months||95% Confidence Interval|Median
727029|NCT00373113|Primary|Progression-Free Survival (PFS)|Time from the date of randomization to the date of the first documentation of objective tumor progression or death due to any cause, whichever occured first.|From time of randomization to every 6 weeks thereafter through 22 months or until death|Intent-to-treat (ITT) population: included all participants who were randomized.||Months||95% Confidence Interval|Median
727030|NCT00373256|Secondary|Biomarkers|Concentrations of plasma proteins (eg, soluble Vascular Endothelial Growth Factor Receptor 2 [VEGFR2] and VEGFR3, VEGF-A, placental growth factor [PlGF], soluble KIT, and possibly soluble PDGFRβ and PDGF) that may be associated with angiogenesis and tumor proliferation.|Day 1 of Cycles 1 through 3 and 5, Day 8 of Cycle 1, and Day 15 of Cycle 1|ITT. Biomarker data were collected, but since the study was stopped early and there were too few events of OS, PFS, etc, data were not analyzed.|||||
727031|NCT00373256|Secondary|EQ - Visual Analog Scale (EQ-VAS)|EQ-VAS score on the self-rated “thermometer,” indicating the patient's own assessment of their health status from 0 (worst) to 100 (best) imaginable health state.|Day 1 of Cycles 1 through 7 and then odd-numbered cycles thereafter until 18 months|ITT. EQ-VAS evaluations were not analyzed since enrollment in this study was terminated early for futility at the first interim analysis.|||||
727032|NCT00373256|Secondary|Euro Quality of Life-5 Dimension (EQ-5D)|EQ-5D: health status in 5 dimensions (mobility, self-care, pain/discomfort, anxiety/depression, usual activities). Three-level scale (1=no problem, 2=some problem, and 3=extreme problem). A single score between 1 and 3 is generated for each domain. For each subject, the outcome rating on the 5 domains could be mapped to a single index through an algorithm. The index ranges between 0 and 1, with the higher score indicating a better health state perceived by the subject.|Day 1 of Cycles 1 through 7 and then odd-numbered cycles thereafter until 18 months|ITT. EQ-5D evaluations were not analyzed since enrollment in this study was terminated early for futility at the first interim analysis.|||||
727033|NCT00373256|Secondary|EORTC QLQ Breast Cancer Module (BR23)|BR23: measured disease related symptoms of dry mouth, eye pain, hair loss, hot flushes, attractiveness, future health, sexual activity, arm/shoulder pain, breast pain, swollen breast, and skin problems on the breast. Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.|Day 1 of Cycles 1 through 7 and then odd-numbered cycles thereafter until 18 months|ITT. BR23 evaluations were not analyzed since enrollment in this study was terminated early for futility at the first interim analysis.|||||
727034|NCT00373256|Secondary|European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30)|EORTC QLQ-C30: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Day 1 of Cycles 1 through 7 and then odd-numbered cycles thereafter until 18 months|ITT. EORTC QLQ-C30 evaluations were not analyzed since enrollment in this study was terminated early for futility.|||||
727035|NCT00373256|Secondary|Percentage of Participants Surviving at 1 and 2 Years|Percentage of those surviving at the end of one year or end of 2 years from the first dose of study treatment.|Year 1, Year 2|ITT.||percentage of participants|||Number
727036|NCT00373256|Secondary|Overall Survival (OS)|OS was defined as the time from date of randomization to death due to any cause. OS (in months) was calculated as (date of death minus randomization date +1) divided by 30.4.|From date of randomization up to 5 years. Survival follow-up changed to 28-days after treatment discontinuation when study was discontinued.|ITT. The median OS for bevacizumab + paclitaxel at the time of data cut off was not reached; therefore, it could not be calculated.||Months||95% Confidence Interval|Median
727037|NCT00373256|Secondary|Duration of Response (DR)|DR=time from the first documentation of objective tumor response (CR or PR) that was subsequently confirmed to first documentation of objective disease progression or death due to any cause, whichever was first. DR was calculated as [the date response ended (ie, date of progressive disease or death) minus first CR or PR date that was subsequently confirmed +1)] divided by 30.4.|From date of randomization through Day 1 and every 8 weeks thereafter up to 18 months or death due to any cause|ITT. DR was calculated for the subgroup of subjects with objective response. 78 subjects reported CR or PR response and were analyzed for DR in each treatment group.||Months||95% Confidence Interval|Median
727038|NCT00373256|Secondary|Number of Participants With Objective Response|Objective response = participants with confirmed complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all target lesions. A PR was defined as a > = 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|From date of randomization through Day 1 and every 8 weeks thereafter up to 18 months|ITT||participants|||Number
727039|NCT00373256|Primary|Progression-Free Survival (PFS)|Time from date of randomization to the date of the first documentation of objective tumor progression or death due to any cause, whichever occurred first. PFS = (first event date minus randomization date +1) divided by 30.4|From date of randomization through Day 1 and every 8 weeks thereafter up to 18 months or death|The intent-to-treat (ITT) population included all patients who were randomized.||Months||95% Confidence Interval|Median
727040|NCT00373269|Secondary|TF-PCA|TF-PCA levels compared between normoglycemic and hyperglycemic subjects.|Baseline|||U/ml||Standard Deviation|Mean
727041|NCT00373269|Primary|FVIIa|FVIIa levels were compared between the normoglycemic and hyperglycemic subjects.|Baseline|||mU/ml||Standard Deviation|Mean
727042|NCT00373295|Primary|Measure of Relapse: Change in Money Spent Between Baseline and Relapse Phase|"This is a measure of marijuana self-administration and relapse since each initial puff costs $7 and is a burden to overcome just to smoke.
Over each 3 day period, the puffs chosen by each participant is averaged for a single value."|Days 1-3 (Baseline) and Days 6-8 (Relapse Phase)|||dollars spent on marijuana||Standard Deviation|Mean
727043|NCT00373334|Secondary|Investigator Assessment of Gastroesophageal Reflux Disease (GERD) Severity|Subjective investigator assessment of GERD severity - rating categories were NONE, MILD, MODERATE, or SEVERE.|8 weeks|The analysis population includes all patients that took drug and reached the 8 week study timepoint.||participants|||Number
727044|NCT00373334|Secondary|Investigator Assessment of Gastroesophageal Reflux Disease (GERD) Relief|Subjective investigator assessment of GERD relief - rating categories were BETTER, NO CHANGE, or WORSE from baseline.|8 weeks|The analysis population includes all patients that took drug and reached the 8 week study timepoint.||participants|||Number
727045|NCT00373334|Primary|Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R) Success|The I-GERQ-R contains 12 questions assessing gastroesophageal reflux disease (GERD) frequency and severity. A low I-GERQ-R score (minimum = 0) indicates minimal symptoms and a high I-GERQ-R score (maximum = 42) indicates more frequent and/or severe symptoms. Success is defined as a reduction in I-GERQ-R score of at least 5 points from baseline, provided a subject did not discontinue due to lack of efficacy or adverse event, and had been treated for at least 4 weeks.|8 weeks|The analysis population includes all patients that took drug and had any efficacy data reported. 5 patients that were lost to follow up (1 nizatidine 2.5 group, 1 nizatidine 5.0 group, 3 placebo group) were not included because they had no efficacy data and had not reported any adverse events.||participants|||Number
727046|NCT00373360|Secondary|Change in Total Number of Times Daily Infusion Pump Alarms With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol||Baseline and Week 8|||number of times per day||Standard Deviation|Mean
727047|NCT00373360|Secondary|Change in Total Number of Times Daily Required to Check Infusion Pump With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol||Baseline and Week 8|||number of times per day||Standard Deviation|Mean
727048|NCT00373360|Secondary|Change in Total Number of Times Daily Required to Disconnect Infusion Pump With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol||Baseline and Week 8|||number of times per day||Standard Deviation|Mean
727049|NCT00373360|Secondary|Change in Total Weekly Time Spent to Prepare Drug With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol||Baseline and Week 8|||minutes||Standard Deviation|Mean
727050|NCT00373360|Secondary|Change in Total Weekly Time Spent to Change Dressing With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol||Baseline and Week 8|||minutes||Standard Deviation|Mean
727051|NCT00373360|Secondary|Change in Total Weekly Time Spent to Connect Drug With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol||Baseline and Week 8|||minutes||Standard Deviation|Mean
727052|NCT00373360|Secondary|Change in Total Weekly Time Spent to Gather/Set-up Materials Associated With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol||Baseline and Week 8|||minutes||Standard Deviation|Mean
727053|NCT00373360|Secondary|Change in Patient Impression of Change of Satisfaction With Therapy From Baseline to Week 8|Subjects were asked to compare their previous experience with Flolan and rate satisfaction with intravenous Remodulin therapy over the past two weeks as much more satisfied, more satisfied, about the same, less satisfied, or much less satisfied.|Baseline and Week 8|||participants|||Number
727054|NCT00373360|Secondary|Change in Patient Impression of Change on Time Spent Dealing With Therapy From Baseline to Week 8|Subjects were asked to compare their previous experience with Flolan and rate how much time was spent dealing with intravenous Remodulin therapy as much less, somewhat less, about the same, somewhat more, or much more.|Baseline and Week 8|||participants|||Number
727055|NCT00373360|Secondary|Change in Patient Impression of Change in Symptoms of PAH From Baseline to Week 8|Subjects were asked to compare their symptoms of PAH as compared to 8 weeks prior and rate as much better, somewhat better, about the same, somewhat worse, or much worse.|Baseline and Week 8|||participants|||Number
727056|NCT00373360|Secondary|Change in Total Score on Quality of Life Questionnaire From Baseline to Week 8|The Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) is a health related quality of life instrument specific to PAH. The total score can range from 0 -75; the higher the score, the worse the outcome.|Baseline and Week 8|||units on a scale||Standard Deviation|Mean
727057|NCT00373360|Secondary|Change in Global Satisfaction Score on Treatment Satisfaction Scale From Baseline to Week 8|The Treatment Satisfaction Questionnaire for Medication (TSQM) is a validated instrument that measures four major dimensions of patient satisfaction with medications: effectiveness, side effects, convenience, and global satisfaction. TSQM Scale scores are computed by adding the items loading on each factor. The lowest possible score is subtracted from this composite score and divided by the greatest possible score minus the lowest possible score. This provided a transformed score between 0 and 1 that should be multiplied by 100 (scale 0-100). A low score indicates low satisfaction and a high score indicates high satisfaction with treatment.|Baseline and Week 8|||units on a scale||Standard Deviation|Mean
727058|NCT00373360|Secondary|Change in Convenience Score on Treatment Satisfaction Scale From Baseline to Week 8|The Treatment Satisfaction Questionnaire for Medication (TSQM) is a validated instrument that measures four major dimensions of patient satisfaction with medications: effectiveness, side effects, convenience, and global satisfaction. TSQM Scale scores are computed by adding the items loading on each factor. The lowest possible score is subtracted from this composite score and divided by the greatest possible score minus the lowest possible score. This provided a transformed score between 0 and 1 that should be multiplied by 100 (scale 0-100). A low score indicates low satisfaction and a high score indicates high satisfaction with treatment.|Baseline and Week 8|||units on a scale||Standard Deviation|Mean
727059|NCT00373360|Secondary|Change in Side-Effects Score on Treatment Satisfaction Scale From Baseline to Week 8|The Treatment Satisfaction Questionnaire for Medication (TSQM) is a validated instrument that measures four major dimensions of patient satisfaction with medications: effectiveness, side effects, convenience, and global satisfaction. TSQM Scale scores are computed by adding the items loading on each factor. The lowest possible score is subtracted from this composite score and divided by the greatest possible score minus the lowest possible score. This provided a transformed score between 0 and 1 that should be multiplied by 100 (scale 0-100). A low score indicates low satisfaction and a high score indicates high satisfaction with treatment.|Baseline and Week 8|||units on a scale||Standard Deviation|Mean
727060|NCT00373360|Secondary|Change in Effectiveness Score on Treatment Satisfaction Scale From Baseline to Week 8|The Treatment Satisfaction Questionnaire for Medication (TSQM) is a validated instrument that measures four major dimensions of patient satisfaction with medications: effectiveness, side effects, convenience, and global satisfaction. TSQM Scale scores are computed by adding the items loading on each factor. The lowest possible score is subtracted from this composite score and divided by the greatest possible score minus the lowest possible score. This provided a transformed score between 0 and 1 that should be multiplied by 100 (scale 0-100). A low score indicates low satisfaction and a high score indicates high satisfaction with treatment.|Baseline and Week 8|||units on a scale||Standard Deviation|Mean
727061|NCT00373360|Secondary|Change in Symptoms of Chest Pain From Baseline to Week 8|The presence or absence of chest pain was documented. If present, the intensity of chest pain was rated mild, moderate, or severe.|Baseline and Week 8|||percentage of participants|||Number
727062|NCT00373360|Secondary|Change in Symptoms of Syncope From Baseline to Week 8|The presence or absence of syncope was documented. If present, the intensity of syncope was rated mild, moderate, or severe.|Baseline and Week 8|||percentage of participants|||Number
727063|NCT00373360|Secondary|Change in Symptoms of Fatigue From Baseline to Week 8|The presence or absence of fatigue was documented. If present, the intensity of fatigue was rated mild, moderate, or severe.|Baseline and Week 8|||percentage of participants|||Number
727064|NCT00373360|Secondary|Change in Symptoms of Dizziness From Baseline to Week 8|The presence or absence of dizziness was documented. If present, the intensity of dizziness was rated mild, moderate, or severe.|Baseline and Week 8|||percentage of participants|||Number
727065|NCT00373360|Secondary|Change in Symptoms of Orthopnea From Baseline to Week 8|The presence or absence of orthopnea was documented. If present, the intensity of orthopnea was rated mild, moderate, or severe.|Baseline and Week 8|||percentage of participants|||Number
727066|NCT00373360|Secondary|Change in Symptoms of Edema From Baseline to Week 8|The presence or absence of edema was documented. If present, the intensity of edema was rated mild, moderate, or severe.|Baseline to Week 8|||percentage of participants|||Number
727067|NCT00373360|Secondary|Change in Symptoms of Dyspnea From Baseline to Week 8|The presence or absence of dyspnea was documented. If present, the intensity of dyspnea was rated mild, moderate, or severe.|Baseline and Week 8|||percentage of participants|||Number
727068|NCT00373360|Secondary|Change in World Health Organization (WHO) Functional Classification of PAH From Baseline to Week 8|"Class I: Patients with pulmonary hypertension but without resulting limitation of physical activity. Ordinary physical activity does not cause undue dyspnea or fatigue, chest pain, or near syncope.
Class II: Patients with pulmonary hypertension resulting in slight limitation of physical activity. These patients are comfortable at rest, but ordinary physical activity causes undue dyspnea or fatigue, chest pain or near syncope.
Class III: Patients with pulmonary hypertension resulting in marked limitation of physical activity. They are comfortable at rest. Ordinary activity causes undue dyspnea or fatigue, chest pain, or near syncope.
Class IV: Patients with pulmonary hypertension with inability to carry out any physical activity without symptoms. These patients manifest signs of right heart failure. Dyspnea and/or fatigue may be present even at rest. Discomfort is increased by any physical activity."|Baseline and Week 8|||percentage of participants|||Number
727069|NCT00373360|Secondary|Change in Borg Dyspnea Score Immediately After Six Minute Walk Test From Baseline to Week 8|The Borg dyspnea score is a 10-point scale rating the maximum level of dyspnea experienced during the 6-minute walk test. The Borg dyspnea score was assessed immediately following the 6-minute walk test. Scores ranged from 0 (for no shortness of breath) to 10 (for greatest shortness of breath ever experienced).|Baseline and Week 8|||units on a scale||Standard Deviation|Mean
727070|NCT00373360|Primary|Change in the Distance Transversed During the 6 Minute Walk Test From Baseline to Week 8.||Baseline and Week 8|"As this was a small open label study, the statistics applied to the results were descriptive. For all efficacy endpoints, data obtained from study assessments during the treatment phase were compared to Baseline.
assessments"||meters||Standard Deviation|Mean
727080|NCT00373490|Secondary|Maximum Concentration (Cmax) at Day 21 (400 mg)||Day 21 (400 mg)|Six (6) participants received vorinostat at 400 mg once daily. Of these, four (4) participants had missing Pharmacokinetics Data on Day 21 because they did not receive study drug on day 21.||μM||Standard Deviation|Geometric Mean
727081|NCT00373490|Secondary|Maximum Concentration (Cmax) at Day 3 (600 mg)||Day 3 (600 mg)|||μM||Standard Deviation|Geometric Mean
727082|NCT00373490|Secondary|Maximum Concentration (Cmax) at Day 1 (600 mg and 400 mg)||Day 1 (600 mg and 400 mg)|Six (6) participants received vorinostat at 400 mg once daily. Of these, one (1) participant had missing Pharmacokinetics Data on Day 1 because the participant vomited after administration on Day 1.||μM||Standard Deviation|Geometric Mean
727223|NCT00362115|Secondary|Change From Baseline in Sitting Clinic Systolic Blood Pressure.|The change in sitting clinic systolic blood pressure measured at final visit or week 8 relative to baseline. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.|Baseline and Week 8|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
727071|NCT00373425|Secondary|Number of Participants With Adverse Events (AEs)|"An AE was defined as any untoward medical occurrence in a study participant and did not necessarily have a causal relationship with study treatment.
An AE was considered serious if it resulted in death, a life-threatening situation, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of a participant, other important medical events, or is on the Astellas Always Serious List.
A drug-related AE was any AE with at least a possible relationship to study treatment as assessed by the investigator. Severity was graded by the investigator according to the National Cancer Institute Common Terminology Criteria for Adverse Events, v3.0, where Grade 1=Mild AE; Grade=2 Moderate AE; Grade 3=Severe AE; Grade 4=Life-threatening or disabling; Grade 5=Death related to AE. AEs leading to death include deaths that occurred more than 30 days after the last dose of study drug."|From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 11.9 months for erlotinib and 21.9 months for placebo. Data are based off the 11 June 2014 data cut-off date.|Randomized Cohort, safety analysis set: all randomized participants who received at least one dose of study drug. One participant in the Randomized Cohort assigned to the erlotinib arm received placebo instead due to a dispensing error and is included in the placebo group for safety analyses.||participants|||Number
727072|NCT00373425|Secondary|Overall Survival in Participants With EGFR Mutation - Positive Tumors|"Overall survival is defined as the time from the date of randomization until the documented date of death. Participants who were still alive were censored on the last day they were known to be alive.
Activating EGFR mutation-positive is defined as exon 19 deletion or exon 21 L858R (or both) detected."|Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 11 June 2014 (maximum time on follow-up was 78 months)|Randomized cohort full analysis participants who were EGFR mutation positive||months||95% Confidence Interval|Median
727073|NCT00373425|Secondary|Overall Survival in Participants With EGFR Mutation - Positive Tumors|"Overall survival is defined as the time from the date of randomization until the documented date of death. Participants who were still alive were censored on the last day they were known to be alive.
Activating EGFR mutation-positive is defined as exon 19 deletion or exon 21 L858R (or both) detected."|Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 08 April 2013 (maximum time on follow-up was 64 months)|Randomized cohort full analysis participants who were EGFR mutation positive||months||95% Confidence Interval|Median
727074|NCT00373425|Primary|Disease Free Survival (DFS)|DFS is the time from the date of randomization until the first day that non-small cell lung cancer (NSCLC) relapse is documented by radiological exam and/or biopsy, or until death in the absence of relapse. After randomization, NSCLC relapse was based on radiological evidence or biopsy, as determined by the investigator. Participants without a DFS event were censored on the last adequate radiological assessment date.|Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cutoff date of 11 June 2014 (maximum time on follow-up was 78 months).|Randomized cohort full analysis set (all randomized participants).||months||95% Confidence Interval|Median
727075|NCT00373425|Secondary|Disease-free Survival in Participants With EGFR Mutation - Positive Tumors|Disease-free survival (DFS) is the time from the date of randomization until the first day NSCLC relapse is documented by radiological exam and/or biopsy, or until death in the absence of relapse. After randomization, NSCLC relapse was based on radiological evidence or biopsy, as determined by the investigator. Participants without a DFS event were censored on the last adequate radiological assessment date. Activating EGFR mutation-positive is defined as exon 19 deletion or exon 21 L858R (or both) detected.|Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 11 June 2014 (maximum time on follow-up was 78 months).|Randomized cohort full analysis set participants who are EGFR mutation positive||months||95% Confidence Interval|Median
727076|NCT00373425|Secondary|Disease-free Survival in Participants With EGFR Mutation - Positive Tumors|Disease-free survival (DFS) is the time from the date of randomization until the first day NSCLC relapse is documented by radiological exam and/or biopsy, or until death in the absence of relapse. After randomization, NSCLC relapse was based on radiological evidence or biopsy, as determined by the investigator. Participants without a DFS event were censored on the last adequate radiological assessment date. Activating EGFR mutation-positive is defined as exon 19 deletion or exon 21 L858R (or both) detected.|Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 08 April 2013 (maximum time on follow-up was 64 months).|Randomized cohort full analysis set participants who are EGFR mutation positive||months||95% Confidence Interval|Median
727077|NCT00373425|Secondary|Overall Survival (OS)|Overall survival was defined as the time from the date of randomization until the documented date of death. Participants who were still alive were censored on the last day they were known to be alive.|Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 11 June 2014 (maximum time on follow-up was 78 months).|Randomized cohort full analysis set||months||95% Confidence Interval|Median
727078|NCT00373425|Secondary|Overall Survival (OS)|Overall survival was defined as the time from the date of randomization until the documented date of death. Participants who were still alive were censored on the last day they were known to be alive.|Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 08 April 2013 (maximum time on follow-up was 64 months).|Randomized cohort full analysis set||months||95% Confidence Interval|Median
727079|NCT00373425|Primary|Disease Free Survival (DFS)|DFS is the time from the date of randomization until the first day non-small cell lung cancer (NSCLC) relapse is documented by radiological exam and/or biopsy, or until death in the absence of relapse. After randomization, NSCLC relapse was based on radiological evidence or biopsy, as determined by the investigator. Participants without a DFS event were censored on the last adequate radiological assessment date.|Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 08 April 2013 (maximum time on follow-up was 64 months).|Randomized cohort full analysis set (all randomized participants).||months||95% Confidence Interval|Median
728442|NCT00380250|Secondary|Month 3 Spontaneous Bowel Movement Frequency Rates Change From Baseline|Any bowel movement not associated with rescue medication use|Change from baseline for month 3|ITT with LOCF||SBM/week||Standard Deviation|Mean
727083|NCT00373490|Secondary|Area Under the Curve (AUC(0-infinity) at Day 21 (400 mg)|Area Under Curve (AUC(0-infinity))=Area under the plasma concentration versus time curve (AUC) from time zero to 24 ｈours. It is obtained from AUC (0 - 24) plus AUC (24 - ∞)|Day 21 (400 mg)|Six (6) participants received vorinostat at 400 mg once daily. Of these, four (4) participants had missing Pharmacokinetics Data on Day 21 because they did not receive study drug on day 21.||μM·hr||Standard Deviation|Geometric Mean
727084|NCT00373490|Secondary|Area Under the Curve (AUC(0-infinity)) at Day 3 (600 mg)|Area Under Curve (AUC(0-infinity))=Area under the plasma concentration versus time curve (AUC) from time zero to 24 ｈours. It is obtained from AUC (0 - 12) plus AUC (12 - ∞)|Day 3 (600 mg)|||μM·hr||Standard Deviation|Geometric Mean
727085|NCT00373490|Secondary|Area Under the Curve (AUC(0-infinity)) at Day 1 (600 mg and 400 mg)|Area Under Curve (AUC(0-infinity))=Area under the plasma concentration versus time curve (AUC) from time zero to extrapolated infinite time (o- ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). At 600 mg, t=12 hours and at 400 mg, t=24 hours.|Day 1 (600 mg and 400 mg)|Six (6) participants received vorinostat at 400 mg once daily. Of these, one (1) participant had missing Pharmacokinetics Data on Day 1 because the participant vomited after administration on Day 1.||μM·hr||Standard Deviation|Geometric Mean
727086|NCT00373490|Primary|Number of Participants With a Dose Limiting Toxicity (DLT)|Dose Limiting Toxicity = Drug-related side effects that are serious enough to prevent an increase in dose or level of that treatment|21 Days (first cycle)|Six (6) participants received vorinostat at 400 mg once daily. Of these, 2 participants did not complete the first cycle resulting in the drug compliance falling below 75%, and thus these participants were excluded from the DLT assessment.||Participants|||Number
727087|NCT00373529|Other Pre-specified|Number of Participants Achieving Overall Remission After A Maximum of Two Cycles by Subgroup of Baseline Prognostic Factors|The number of participants within each subgroup of baseline prognostic factors of the full analysis set who achieved a best response of either a complete response (CR) or a complete response in the absence of platelet recovery (CRp) as determined by the Independent Response Review Panel following a maximum of two cycles of treatment.|approximately Month 2|Full analysis set (FAS) of participants who achieved remission and had baseline prognostic factor||participants|||Number
727088|NCT00373529|Secondary|Percentage of Participants Who Died Within Thirty Days of Treatment (30-day Mortality Rate)|Percentage of participants who died within 30 days of the first dose of study drug, regardless of cause.|up to Day 30|Full analysis set||percentage of participants|||Number
727089|NCT00373529|Secondary|Overall Participant Counts Summarizing Adverse Events (AEs) During the Treatment and Follow-up Periods|"Participants with AEs that occurred during the treatment and follow-up periods. AEs were classified according to severity (graded using National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 3.0) and relationship to study drug. Treatment emergent is defined as any event that either first presents after baseline or worsens in severity after baseline.
NCI Common Terminology Criteria for Severity:
Grade 1= Mild AE, Grade 2= Moderate AE, Grade 3= Severe AE, Grade 4= Life-threatening or disabling AE, Grade 5= Death related to AE"|Up to 2 years|Full analysis set||participants|||Number
727090|NCT00373529|Secondary|Kaplan Meier Estimates for Overall Survival (OS)|OS was defined as the number of days from first dose of clofarabine until death for all participants, plus 1 day.|Up to 2 years|Full analysis set||weeks||95% Confidence Interval|Median
727091|NCT00373529|Secondary|Kaplan Meier Estimate for Disease-free Survival (DFS)|DFS was defined as the number of days from achievement of IRRP-determined overall response until IRRP-determined disease recurrence or death (any cause), regardless of intervening alternative antileukemic treatment, plus 1 day.|Up to 2 years|Full analysis set (FAS) of participants who achieved remission.||weeks||95% Confidence Interval|Median
727092|NCT00373529|Secondary|Kaplan Meier Estimate for Duration of Remission (DOR)|DOR was defined as the number of days from achievement of OR as assessed by the Independent Response Review Panel (IRRP) until IRRP-determined disease recurrence or death (any cause), plus 1 day. Participants who initiated alternative antileukemic treatment while in remission were censored on the date the therapy was initiated or on the date of last follow-up.|Up to 2 years|Full analysis set (FAS) of participants who achieved remission.||weeks||95% Confidence Interval|Median
727093|NCT00373529|Primary|Percentage of Participants Achieving Overall Remission (OR) After No More Than Two Cycles (Approximately Month 2)|Best response was assessed by the Independent Response Review Panel(IRRP) after two cycles of treatment. Overall remission(OR) is the sum of complete remission(CR) and complete remission in the absence of platelet recovery(CRp). CR includes normal values for peripheral blood cell counts (absolute neutrophil and platelet) and leukemic blast cells from bone marrow biopsy or aspirate, and absence of extramedullary disease. Partial remission(PR) includes recovery of peripheral blood cells with improved but still abnormal values in leukemic blast cells.|approximately Month 2|Full analysis set (FAS)||percentage of participants|||Number
727094|NCT00373685|Other Pre-specified|Percentage of Participants With Non-study Medication Utilization|Non-study medication utilization associated with initial treatment defined as narcotic analgesics and acetaminophen use.|Baseline through week 24 or ET|ITT; N= number of evaluable participants analyzed||Percentage of participants|||Number
727095|NCT00373685|Other Pre-specified|Percentage of Participants With Proton Pump Inhibitor (PPI) and Other Gastric Protective Drug Utilization|PPI and other gastric protective drug (defined as Histamine-2 receptor antagonists [H2RA], misoprostol, sucralfate, and others such as antacids) utilization.|Baseline through week 24 or ET|ITT; any randomized participant who received at least one dose of study medication; N= number of evaluable participants analyzed||Percentage of participants|||Number
727096|NCT00373685|Other Pre-specified|Percentage of Participants With Positive Blood Fecal Occult|Positive blood fecal occult; blood in feces that is not visibly apparent|Week 24 or ET|ITT||Percentage of participants|||Number
727097|NCT00373685|Secondary|Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Duration of Pain Relief|Percentage of participants who reported Very Satisfied or Satisfied with efficacy of current pain medication questions on the PTSS Efficacy, subscale for duration of pain relief provided by medication, scale ranged from Very Satisfied (1) to Very Dissatisfied (5). Possible range of scores 1 to 15.|Baseline, Weeks 8, 16, 24 or ET|ITT; N=number of evaluable participants analyzed; n= number of evaluable participants analyzed at specific time point; LOCF||Percentage of participants|||Number
728443|NCT00380250|Secondary|Month 2 Spontaneous Bowel Movement Frequency Rates Change From Baseline|Any bowel movement not associated with rescue medication use|Change from baseline for month 2|ITT with LOCF||SBM/week||Standard Deviation|Mean
727098|NCT00373685|Secondary|Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Amount of Pain Relief|Percentage of participants who reported Very Satisfied or Satisfied with efficacy of current pain medication questions on the PTSS Efficacy subscale for the amount of pain relief medication provided, scale ranged from Very Satisfied (1) to Very Dissatisfied (5). Possible range of scores 1 to 15.|Baseline, Weeks 8, 16, 24 or ET|ITT; N=number of evaluable participants analyzed; n= number of evaluable participants analyzed at specific time point; LOCF||Percentage of participants|||Number
727099|NCT00373685|Secondary|Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Time to Pain Relief|Percentage of participants who reported Very Satisfied or Satisfied with efficacy of current pain medication questions on the PTSS Efficacy subscale for the time it took medication to work, scale ranged from Very Satisfied (1) to Very Dissatisfied (5). Possible range of scores 1 to 15.|Baseline, Weeks 8, 16, 24 or ET|ITT; N=number of evaluable participants analyzed; n= number of evaluable participants analyzed at specific time point; LOCF||Percentage of participants|||Number
727100|NCT00373685|Secondary|Percentage of Participants Satisfied With Efficacy of Current Pain Medication Overall|Percentage of participants who reported Very Satisfied or Satisfied with current pain medication question on the Patient Treatment Satisfaction Scale (PTSS), scale ranged from Very Satisfied (1) to Very Dissatisfied (5).|Baseline, Weeks 8, 16, 24 or ET|ITT; N=number of evaluable participants analyzed; n=number of evaluable participants analyzed at specific time point; LOCF||Percentage of participants|||Number
727101|NCT00373685|Secondary|Percentage of Participants With Clinically Significant Decrease in Hct and/or Hb From Baseline|Clinically significant decrease in Hct (greater than or equal to 10 percent [≥10%]) and/or decrease in Hb (≥ 2 g/dL).|Baseline, Weeks 8, 16, 24 or ET|ITT; N=number of evaluable participants analyzed; n=number of evaluable participants analyzed at the specific time point; LOCF||Percentage of participants|||Number
727102|NCT00373685|Secondary|Change From Baseline Hct at Week 24||Week 24 or ET|ITT; N= number of evaluable participants analyzed; LOCF||Percent||Standard Error|Least Squares Mean
727103|NCT00373685|Secondary|Hematocrit (Hct) at Baseline||Baseline|ITT; N= number of evaluable participants analyzed||Percent||Standard Deviation|Mean
727104|NCT00373685|Secondary|Change From Baseline Hb at Week 24||Baseline and Week 24 or ET|ITT; N=number of evaluable participants analyzed; Last observation carried forward (LOCF)||g/dL||Standard Error|Least Squares Mean
727105|NCT00373685|Secondary|Hemoglobin (Hb) at Baseline||Baseline|ITT; N= number of evaluable participants analyzed||gram per deciliter (g/dL)||Standard Deviation|Mean
727106|NCT00373685|Secondary|Percentage of Participants Who Withdrew Due to GI Adverse Events (AEs)|GI AEs defined using MedDRA SOC 'Gastrointestinal Disorders' but excluding HLGT's: Benign Neoplasms Gastrointestinal, Dental and Gingival Conditions, Oral Soft Tissue Conditions, Salivary Gland Conditions and Tongue Conditions|Baseline through week 24 or ET|ITT||Percentage of participants|||Number
727107|NCT00373685|Secondary|Percentage of Participants With Moderate to Severe Abdominal Symptoms|"Abdominal symptoms coded using the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) 'Gastrointestinal Disorders' high level group term (HLGT) equal to “Gastrointestinal Signs and Symptoms; where moderate indicated the gastrointestinal adverse event (GI AE) interfered to some extent with the participants’ usual function and severe indicated the GI AE interfered significantly with participants’ usual function."|Baseline through week 24 or ET|ITT;||Percentage of participants|||Number
727108|NCT00373685|Primary|Percentage of Participants With Clinically Significant Upper and/or Lower Gastrointestinal Events (CSULGIEs)|CSULGIE defined as any of the following: gastroduodenal (GD) hemorrhage; gastric outlet obstruction; GD, small or large bowel perforation; small or large bowel hemorrhage; acute gastrointestinal (GI) hemorrhage of unknown origin; small bowel obstruction; clinically significant anemia/blood loss of defined GI origin or presumed occult GI origin.|Baseline through week 24 or Early Termination (ET)|Intent-to-Treat (ITT) Population: randomized participants||Percentage of participants|||Number
727109|NCT00373698|Secondary|SF-36 Physical Component||3 and 6 months after initial assessment|||units on a scale||Standard Deviation|Mean
727110|NCT00373698|Secondary|SF-36 Mental Component||3 and 6 months after initial assessment|||units on a scale||Standard Deviation|Mean
727111|NCT00373698|Secondary|Depression|Measure using the Hopkins Symptom Checklist-20|3 and 6 months after initial assessment|||units on a scale||Standard Deviation|Mean
727112|NCT00373698|Primary|PTSD Symptom Severity|PTSD Symptom Severity was measured using the Postraumatic Diagnostic Scale (PDS)|3 and 6 months after initial assessment|||units on a scale||Standard Deviation|Mean
727113|NCT00373880|Secondary|Plasma Cocaine|Mean plasma cocaine levels after a single administration of each cocaine dose as a function of aripiprazole and cocaine dose.|8 minutes|Eight participants were included in this within-subjects analysis.||ng/mL||Standard Deviation|Mean
727114|NCT00373880|Secondary|Subjective Effects of Cocaine|"Mean Visual Analog Scale (VAS) ratings (items: Quality, Pay for Dose, Good Drug Effect, and Cocaine Craving) from 0-100mm as a function of cocaine dose and aripiprazole dose 4 min following a single administration of cocaine (the “sample dose”) at the start of the session.
For Quality item, the perceived quality of the drug is rated. The higher the rating, the better quality the drug was perceived to be.
For Pay for Dose item, the likelihood that the participant would pay for the drug is indicated. Higher ratings indicate a better likelihood that the person would pay for the dose received.
For Good Drug Effect, the likelihood of feeling a good drug effect is indicated. The higher the number, the more of a good drug effect the person reported.
For Cocaine Craving, the intensity of craving is reported. Higher scores indicate more craving for cocaine."|5 days|Eight participants were included in this within-subjects analysis.||Scores on a scale of 0-100mm||Standard Error|Mean
727115|NCT00373880|Primary|Cocaine Self-administration|"Mean number of cocaine choices as a function of cocaine dose and aripiprazole dose (n=8).
Participants sampled the dose of cocaine available for the session and then had five choices to respond for money ($5.00) or cocaine using a modified progressive-ratio schedule."|5 days|Eight participants were included in this within-subjects analysis.||Number of Choices||Standard Error|Mean
727143|NCT00374244|Secondary|Trail Making Test: Trail A|Working memory by Digit Span and Letter Number Sequencing, and attention/executive functions were measured by the Trail Making Test (Parts A and B). This is an assessment of attention/executive function, it does not have an interpret-able range of scores like a traditional scale. Subjects makes trails on paper against time.|Baseline|Intent to Treat Analysis||seconds||Standard Deviation|Mean
727116|NCT00373958|Secondary|Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose|Geometric mean titer (GMT) as measured by opsonophagocytic activity assay (OPA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|one month after the infant series and the toddler dose|Evaluable immunogenicity (per protocol) population of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations, (n) = number of participants with a determinate antibody titer for the specified serotype.||titer||95% Confidence Interval|Geometric Mean
727117|NCT00373958|Secondary|Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose|Percentage of participants achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after infant series and one month after toddler dose|Evaluable immunogenicity (per protocol) population of eligible participants who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations;(n) = number of participants with a determinate postinfant series OPA antibody titer to the given serotype.||percentage of participants||95% Confidence Interval|Number
727118|NCT00373958|Primary|Percentage of Participants Reporting Pre-specified Local Reactions|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant ([Sig.], present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate ([Mod.], 2.5 to 7.0 cm); Severe ([Sev.], > 7.0 cm). Participants may have been represented in more than 1 category.|Within 7 days after each dose|Safety population who received the given vaccination. (n)= number of participants reporting yes for at least 1 day or no for all days.||Percentage of participants|||Number
727119|NCT00373958|Primary|Percentage of Participants Reporting Pre-specified Systemic Events|Systemic events (any fever [Fv] ≥ 38 degrees Celsius [C], decreased (decr.) appetite, irritability, increased (incr.) sleep, decreased sleep, and hives [urticaria], use of antipyretic medication [med] to treat or prevent symptoms [sx]) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 7 days after each dose|Safety population who received the given vaccination. (n)= number of participants reporting yes for at least 1 day or no for all days.||Percentage of participants|||Number
727120|NCT00373958|Secondary|Geometric Mean Antibody Concentration of Rubella in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose||one month after the toddler dose|The all-available toddler immunogenicity population included all subjects who had at least 1 valid and determinate assay result before (excluding postinfant) or after the toddler dose. N = number of participants with a determinate antibody concentration or index value for the specified concomitant antigen.||IU/mL||95% Confidence Interval|Geometric Mean
727121|NCT00373958|Secondary|Geometric Mean Antibody Concentration of Measles, Mumps, and Varicella ELISA in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose|"Normalization was performed for unit of measure index value as Index Value of 1.00 = 10 mIU/mL."|one month after the toddler dose|The all-available toddler immunogenicity population included all subjects who had at least 1 valid and determinate assay result before (excluding postinfant) or after the toddler dose. N = number of participants with a determinate antibody concentration or index value for the specified concomitant antigen.||index value||95% Confidence Interval|Geometric Mean
727122|NCT00373958|Secondary|Geometric Mean Antibody Concentration of Hib PRP in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose||one month after the toddler dose|The all-available toddler immunogenicity population included all subjects who had at least 1 valid and determinate assay result before (excluding postinfant) or after the toddler dose. N = number of participants with a determinate antibody concentration or index value for the specified concomitant antigen.||µg/mL||95% Confidence Interval|Geometric Mean
727123|NCT00373958|Secondary|Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Vaccine Antigens Induced by Measles, Mumps, Rubella, Varicella (MMR-V) and Haemophilus Influenzae Type b (Hib)||One month after toddler dose (13 to 16 months of age)|Evaluable immunogenicity (per protocol) population of eligible participants who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.(n)=number of participants with a determinate posttoddler dose antibody concentration to the given concomitant antigen.||percentage of participants||95% Confidence Interval|Number
727124|NCT00373958|Primary|Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series|Predefined Antibody Levels for Haemophilus Influenzae Type b ([Hib] 0.15 µg/mL or 1.0 µg/mL), Diphtheria Toxoid (0.1 International Units [IU]/mL), and Pertussis antigens (Pertussis filamentous hemagglutinin [FHA] 40.5 Elisa Units [EU]/mL, Pertussis toxoid [PT] 16.5 EU/mL, Pertussis pertactin [PRN] 26 EU/mL).|One Month After the Infant Series (7 months of age)|Evaluable immunogenicity (per protocol) population who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations. (n) = number of participants with a determinate postinfant series antibody concentration to the given concomitant antigen.||Percentage of participants||95% Confidence Interval|Number
727125|NCT00373958|Primary|Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose|Antibody concentration/geometric mean concentration as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|1 Month After the Toddler Dose|Evaluable immunogenicity (per protocol) population of eligible participants, had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate antibody concentration for the specified serotype.||μg/mL||95% Confidence Interval|Geometric Mean
727267|NCT00362375|Primary|Condom Use During Vaginal Sex With Any Male Partner|Percentage of women who used condoms during vaginal intercourse with any male partner during the past 3 months|Past 3 months|Women who were sexually active at 3-month follow-up and who provided data on outcome measure||Percent|||Number
727126|NCT00373958|Primary|Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series|Percentages of Participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35 μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after the 3-dose infant series (7 months of age)|Evaluable immunogenicity (per protocol) population consisting of participants who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate IgG antibody concentration to the given serotype.||percentage of participants||95% Confidence Interval|Number
727127|NCT00374088|Post-Hoc|Urine Output|Total urine output over the first 24 hours postoperative|24 hours|||mL||Standard Deviation|Mean
727128|NCT00374088|Post-Hoc|Max Creatinine|Maximum serum creatinine over first 3 days postoperative.|72 hours|||mg/dL||Standard Deviation|Mean
727129|NCT00374088|Primary|Maximum Decline in Measured Cardiac Output|Serial cardiac output was measured by thermodilution. The outcome of maximum decline in indexed cardiac output from 1 hour postoperative to lowest output within 24 hours postoperative was then calculated and compared between NAC and placebo groups.|24 hours|Patients in which the surgeon was technically able to place a 4 French thermodilution catheter into the pulmonary artery at the time of surgery had cardiac output measured.||L/min/m2||Standard Deviation|Mean
727130|NCT00374127|Secondary|Heart Rate|Heart rate averaged across all post-smoking time points when marijuana was smoked as joints and blunts.|180 minutes|Twenty-four participants were included in this analysis.||BPM||Standard Deviation|Mean
727131|NCT00374127|Secondary|Carbon Monoxide|Expired carbon monoxide averaged across all post-smoking time points when marijuana was smoked as joints and blunts for all participants.|180 minutes|Twenty-four participants were included in this analysis.||ppm||Standard Deviation|Mean
727132|NCT00374127|Secondary|Subjective Effects on VAS|Subjective VAS ratings of ‘Good Drug Effect’ and ‘High’ averaged across all post-smoking time points when marijuana was smoked as joints and blunts analyzed for all participants. Here, participants indicated how they were feeling on a 100-mm line anchored with ‘not at all’ at the left end and ‘extremely’ at the right end, when prompted by a statement|180 minutes|Twenty-four participants were included in this analysis.||Ratings (mm)||Standard Deviation|Mean
727133|NCT00374127|Secondary|Subjective Effects on MRF|"Using the Marijuana Rating Form (MRF), subjective effects of Take Again, Liking, and Strong were assessed. The MRF is a visual analog scale allowing patients to indicate how they feel on a 100-mm line anchored with ‘not at all’ at the left end and ‘extremely’ at the right end, when prompted by a statement."|180 minutes|Twenty four participants were included in this within-subjects analysis.||Ratings (mm)||Standard Deviation|Mean
727134|NCT00374127|Primary|Plasma THC|Plasma THC levels were analyzed to determine pharmacokinetic differences between marijuana cigarettes vs marijuana blunts.|180 minutes|Twenty four participants were included in this within-subjects analysis.||ng/mL||Standard Deviation|Mean
727137|NCT00374231|Other Pre-specified|Time Post Transplant Corticosteroid Withdrawal|The mean days from post transplant corticosteroid withdrawal.|12 months|||days||Standard Deviation|Mean
727138|NCT00374231|Secondary|Patient Survival.||12 months|||participants|||Number
727139|NCT00374231|Primary|Incidence of Biopsy Confirmed Acute Rejection at 12 Months.||12 months|||participants|||Number
727140|NCT00374244|Secondary|Trail Making Test: Trail B|"The Trail Making Test is a neuropsychological test of visual attention and task switching. It consists of two parts in which the subject is instructed to connect a set of 25 dots as fast as possible while still maintaining accuracy. ( Arnett, James A.; Seth S. Labovitz (1995). Effect of physical layout in performance of the Trail Making Test. Psychological Assessment 7 (2): 220–221. doi:10.1037/1040-3590.7.2.220. Retrieved 2012-02-22.)
Part A is used primarily to examine cognitive processing speed. Part B, in which the subject alternates between numbers and letters, is used to examine executive functioning. (Tombaugh, T.N.T.N (2004). Trail Making test A and B: Normative Data Stratified by Age and Education. Archives of Clinical Neuropsychology : The Official Journal of the National Academy of Neuropsychologists 19 (2): 203–214. doi:10.1016/s0887-6177(03)00039-8. Retrieved 2012-01-10.)"|Endpoint (12 weeks)|Intent to Treat Analysis||seconds||Standard Deviation|Mean
727141|NCT00374244|Secondary|Trail Making Test: Trail B|"The Trail Making Test is a neuropsychological test of visual attention and task switching. It consists of two parts in which the subject is instructed to connect a set of 25 dots as fast as possible while still maintaining accuracy. ( Arnett, James A.; Seth S. Labovitz (1995). Effect of physical layout in performance of the Trail Making Test. Psychological Assessment 7 (2): 220–221. doi:10.1037/1040-3590.7.2.220. Retrieved 2012-02-22.)
Part A is used primarily to examine cognitive processing speed. Part B, in which the subject alternates between numbers and letters, is used to examine executive functioning. (Tombaugh, T.N.T.N (2004). Trail Making test A and B: Normative Data Stratified by Age and Education. Archives of Clinical Neuropsychology : The Official Journal of the National Academy of Neuropsychologists 19 (2): 203–214. doi:10.1016/s0887-6177(03)00039-8. Retrieved 2012-01-10.)"|Baseline|Intent to Treat Analysis||seconds||Standard Deviation|Mean
727142|NCT00374244|Secondary|Trail Making Test: Trail A|"The Trail Making Test is a neuropsychological test of visual attention and task switching. It consists of two parts in which the subject is instructed to connect a set of 25 dots as fast as possible while still maintaining accuracy. ( Arnett, James A.; Seth S. Labovitz (1995). Effect of physical layout in performance of the Trail Making Test. Psychological Assessment 7 (2): 220–221. doi:10.1037/1040-3590.7.2.220. Retrieved 2012-02-22.)
Part A is used primarily to examine cognitive processing speed. Part B, in which the subject alternates between numbers and letters, is used to examine executive functioning. (Tombaugh, T.N.T.N (2004). Trail Making test A and B: Normative Data Stratified by Age and Education. Archives of Clinical Neuropsychology : The Official Journal of the National Academy of Neuropsychologists 19 (2): 203–214. doi:10.1016/s0887-6177(03)00039-8. Retrieved 2012-01-10.)"|Endpoint (12 weeks)|Intent to Treat Analysis||seconds||Standard Deviation|Mean
727144|NCT00374244|Secondary|Verbal Learning and Memory: List B|Verbal learning and memory were assessed by the Rey Auditory Verbal Learning Test (RAVLT) List B: Single Trial. This assessment consists of a list of words that the subject repeats back, it does not have an interpret-able range of scores like a traditional scale. Scores are based on number of words repeated back.|Endpoint (12 weeks)|Intent to Treat Analysis||words||Standard Deviation|Mean
727145|NCT00374244|Secondary|Verbal Learning and Memory: List B|Verbal learning and memory were assessed by the Rey Auditory Verbal Learning Test (RAVLT) List B: Single Trial. This assessment consists of a list of words that the subject repeats back, it does not have an interpret-able range of scores like a traditional scale. Scores are based on number of words repeated back.|Baseline|Intent to Treat Analysis||words||Standard Deviation|Mean
727146|NCT00374244|Secondary|Verbal Learning and Memory: List A|Verbal learning and memory were assessed by the Rey Auditory Verbal Learning Test (RAVLT) List A: Total Trials (1-5). This assessment consists of a list of words that the subject repeats back, it does not have an interpret-able range of scores like a traditional scale. Scores are based on number of words repeated back.|Endpoint (12 weeks)|Intent to Treat Analysis||words||Standard Deviation|Mean
727147|NCT00374244|Secondary|Verbal Learning and Memory: List A|Verbal learning and memory were assessed by the Rey Auditory Verbal Learning Test (RAVLT) List A: Total Trials (1-5). This assessment consists of a list of words that the subject repeats back, it does not have an interpret-able range of scores like a traditional scale. Scores are based on number of words repeated back.|Baseline|Intent to Treat Analysis||words||Standard Deviation|Mean
727148|NCT00374244|Secondary|Processing Speed|Processing speed was assessed using using Digit Symbol Coding from the Wechsler Adult Intelligence Scale, Revised (WAIS-R). The tool is used for the assessment of processing speed. The range of scores is 0 to 100- with the higher number indicating greater performance.|Endpoint (12 weeks)|Intent to Treat Analysis||units on a scale||Standard Deviation|Mean
727149|NCT00374244|Secondary|Processing Speed|Processing speed was assessed using using Digit Symbol Coding from the Wechsler Adult Intelligence Scale, Revised (WAIS-R). The tool is used for the assessment of processing speed. The range of scores is 0 to 100- with the higher number indicating greater performance.|Baseline|Intent to Treat Analysis||units on a scale||Standard Deviation|Mean
727150|NCT00374244|Secondary|QTc|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart. ECG machines calculate a corrected QT (QTc). QTc is the corrected QT interval in the EKG. Normal range is from 430-470ms.|Endpoint (12 weeks)|Intention to Treat||ms||Standard Deviation|Mean
727151|NCT00374244|Secondary|QTc|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart. ECG machines calculate a corrected QT (QTc). QTc is the corrected QT interval in the EKG. Normal range is from 430-470ms.|Baseline|Intention to Treat||ms||Standard Deviation|Mean
727152|NCT00374244|Secondary|Verbal Fluency|Verbal fluency was measured using the Controlled Word Association Test (COWAT). There is no range for this measure, as it is not a scale. The subjects can generate as many new words as they can, so there is no maximum. The greater the number of words one generates indicates better performance.|Endpoint (12 weeks)|Intent to Treat Analysis||words||Standard Deviation|Mean
727153|NCT00374244|Secondary|Verbal Fluency|Verbal fluency was measured using the Controlled Word Association Test (COWAT). There is no range for this measure, as it is not a scale. The subjects can generate as many new words as they can, so there is no maximum. The greater the number of words one generates indicates better performance.|Baseline|Intent to Treat Analysis||words||Standard Deviation|Mean
727154|NCT00374244|Primary|Scale for the Assessment of Negative Symptoms (SANS)|The Scale for the Assessment of Negative Symptoms (SANS) is a rating scale to measure negative symptoms in schizophrenia. The scale has 25 items (20 individual and 5 global) rated on scale of 0‐5 (higher rating: greater severity). SANS is split into 5 domains, and within each domain separate symptoms are rated from 0 (absent) to 5 (severe). Domains include: Affective Flattening or Blunting, Alogia, Avolition - Apathy, Anhedonia - Asociality, Attention. The total range of the SANS is from 0 to 120.|Endpoint (12 weeks)|Analyzed intent to treat.||units on a scale||Standard Error|Least Squares Mean
727155|NCT00374244|Primary|Scale for the Assessment of Negative Symptoms (SANS)|The Scale for the Assessment of Negative Symptoms (SANS) is a rating scale to measure negative symptoms in schizophrenia. The scale has 25 items (20 individual and 5 global) rated on scale of 0‐5 (higher rating: greater severity). SANS is split into 5 domains, and within each domain separate symptoms are rated from 0 (absent) to 5 (severe). Domains include: Affective Flattening or Blunting, Alogia, Avolition - Apathy, Anhedonia - Asociality, Attention. The total range of the SANS is from 0 to 120.|baseline|Analyzed intent to treat.||units on a scale||Standard Error|Least Squares Mean
727156|NCT00374244|Secondary|CGI Improvement Scale (CGI‐I)|"CGI Improvement Scale (CGI‐I) higher rating correlates with worsening of condition (vs. improvement with lower rating). The CGI-I is scored from 1 to 7 where 1 = 'very much improved' and 7 = 'very much worse'. Clinicians are asked to rate total improvement in the following manner: ...in your judgement, it is due entirely to drug treatment. Compared to his condition at admission to the project, how much has he changed?"|Endpoint (12 weeks)|Analyzed intent to treat.||units on a scale||Standard Error|Least Squares Mean
727157|NCT00374244|Secondary|CGI Severity of Illness Scale (CGI‐S)|CGI Severity of Illness Scale (CGI‐S) assesses severity of illness on 1‐7 scale. Clinicians' experience is used to gauge the severity of illness from 'normal' (value=1) to 'among the most extremely ill patients' (value=7). The higher rating correlates with more severely ill.|Endpoint (12 weeks)|Analyzed intent to treat.||units on a scale||Standard Error|Least Squares Mean
727158|NCT00374244|Secondary|CGI Severity of Illness Scale (CGI‐S)|CGI Severity of Illness Scale (CGI‐S) assesses severity of illness on 1‐7 scale. Clinicians' experience is used to gauge the severity of illness from 'normal' (value=1) to 'among the most extremely ill patients' (value=7). The higher rating correlates with more severely ill.|baseline|Analyzes intent to treat.||units on a scale||Standard Error|Least Squares Mean
727207|NCT00362115|Secondary|Change From Baseline in the 24-36-Hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 24-36-hour mean diastolic blood pressure measured at week 8 relative to the 12-hour mean measured at baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-36-hour mean is the average of all measurements recorded from 24 to 36 hours after dosing; the 12-hour mean is the average of the first 12 hours after dosing.|Baseline and Week 8.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
727159|NCT00374244|Primary|Brief Psychiatric Rating Scale (BPRS) Total Score|The Brief Psychiatric Rating Scale (BPRS) is an 18‐item instrument. The items are anchored on a 7‐point scale (higher rating: greater severity). Total scores range from 18 to 126 (higher score: greater severity). The instrument covers areas including: somatic concerns, anxiety, emotional withdrawal, conceptual disorganization, guilt feelings, tension, mannerisms and posturing, grandiosity, depressive mood, hostility, suspiciousness, hallucinatory behavior, motor retardation, uncooperativeness, unusual thought content, blunted affect, excitement and disorientation.|Endpoint (12 weeks)|Subjects were analyzed intent to treat.||units on a scale||Standard Error|Least Squares Mean
727160|NCT00374244|Primary|Brief Psychiatric Rating Scale (BPRS) Total Score|The Brief Psychiatric Rating Scale (BPRS) is an 18‐item instrument. The items are anchored on a 7‐point scale (higher rating: greater severity). Total scores range from 18 to 126 (higher score: greater severity). The instrument covers areas including: somatic concerns, anxiety, emotional withdrawal, conceptual disorganization, guilt feelings, tension, mannerisms and posturing, grandiosity, depressive mood, hostility, suspiciousness, hallucinatory behavior, motor retardation, uncooperativeness, unusual thought content, blunted affect, excitement and disorientation.|Baseline|Subjects were analyzed intent to treat.||units on a scale||Standard Error|Least Squares Mean
727161|NCT00374322|Secondary|Number of Participants With the Indicated Electrocardiogram (ECG) Findings|12-lead ECG measurements were taken at Screening and at study conclusion/withdrawal. The number of participants with normal, abnormal clinically significant (CS), and abnormal not clinically significant (NCS) ECG findings, as classified by the investigator, were summarized. Participants with missing values were categorized as missing. Data for the primary analysis (conducted in 2011) are reported.|Screening and Month 12/Early Withdrawal Visit|SP. Only those participants (par.) available at the specified time points were analyzed. Two par. were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.||Participants|||Number
727162|NCT00374322|Secondary|Number of Participants Experiencing Primary or Secondary Cardiac Events|A cardiac event is classified as a primary cardiac endpoint (PCE) or a secondary cardiac endpoint (SCE). PCE is defined as: cardiac death (cardiac death due to heart failure, myocardial infarction, or arrhythmia;or probable cardiac death defined as sudden, unexpected death within 24 hours of a definite or probable cardiac event); severe symptomatic congestive heart failure (CHF) (as per New York Heart Association [NYHA] Class III or IV and an absolute decrease in left ventricular ejection fraction [LVEF] of more than 10 percentage points from Baseline and to a left ventricular ejection fraction [LVEF] value below 50%). SCE is defined as asymptomatic or mildly symptomatic cardiac events (NYHA Class I or II) and a significant decrease in LVEF, defined as an absolute decrease in LVEF of more than 10 percentage points from Baseline and to an LVEF value below 50%.|From the date of randomization up to 12 months|Safety Population (SP). Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm. Data for the primary analysis (conducted in 2011) are reported.||Participants|||Number
727163|NCT00374322|Secondary|Number of Participants With Non-laboratory Toxicities of the Indicated Toxicity Grades|"Non-laboratory toxicities are defined as adverse events (AEs). The number of partcipants with any treatment-emergent AE of the indicated toxicity grade are summarized. Toxicity grading was according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 as follows: Grade 1=mild; Grade 2=moderate; Grade 3=severe; Grade 4=life threatening; Grade 5=death. The events that were not given a toxicity grade are categorized as Not Applicable."|From the first dose of study treatment up to 12 months|Safety Population. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm. Data for the primary analysis (conducted in 2011) are reported.||Participants|||Number
727164|NCT00374322|Secondary|Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters|"The clinical chemistry parameters assessed were: alanine amino transferase (ALT), albumin, alkaline phosphatase (ALP), aspartate amino transferase (AST), bicarbonate, blood urea nitrogen (BUN), bone alkaline phosphatase (Bone ALP), calcium, chloride, creatinine, creatinine clearance (Cr. Clearance), creatinine clearance estimated (Cr. Clrnc. est.), glucose, potassium, sodium, total bilirubin (Total Bln), total protein, urea, and uric acid. The Baseline (BL) value is the last available pre-treatment result recorded. Any post-Baseline value was based on results recorded at scheduled or unscheduled post-Baseline visits. The prevalence of values lying outside the reference (ref.) range (high or low) was presented for BL and any post-Baseline (APBL) visit. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm."|At Baseline and every 6 weeks thereafter up to Month 12/Early Withdrawal Visit|Safety Population (primary analysis [conducted in 2011]). Only those participants available (represented as n=X, X in the category titles) at the specified time points were analyzed. Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Safety Population.||Participants|||Number
727165|NCT00374322|Secondary|Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters|"The hematology parameters assessed were: basophils (Bs) in giga (10^9) per liter (GI/L) and in percentage (%), eosinophils (Eo) in GI/L and %, hematocrit, hemoglobin, lymphocytes (Lmph) in GI/L and %, monocytes (Mono) in GI/L and %, platelet count, Red Blood Cell (RBC) count, total neutrophil count (TNC) in GI/L and %, and White Blood Cell (WBC) count. The Baseline (BL) value is the last available pre-treatment result recorded. Any post-Baseline value was based on results recorded at any scheduled or unscheduled post-Baseline visits. The prevalence of values lying outside the reference (ref.) range (high or low) is presented for BL and any post-Baseline (APBL) visit. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm. Data for the primary analysis (conducted in 2011) are reported."|At Baseline and every 3 months thereafter up to Month 12/Early Withdrawal Visit|Safety Population (SP): all randomized participants (par.) who received >=1 dose of randomized treatment. Only those par. available (n=X, X in the category titles) at the specified time points were analyzed. Different par. may have been analyzed for different parameters, so the overall number of par. analyzed reflects everyone in the SP.||Participants|||Number
727224|NCT00362115|Primary|Change From Baseline in Sitting Clinic Diastolic Blood Pressure.|The change in sitting clinic diastolic blood pressure measured at final visit or week 8 relative to baseline. Diastolic blood pressure is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements.|Baseline and Week 8.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
727166|NCT00374322|Secondary|Change From Baseline in the SF-36 v2 Domain Scores for Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH)|The SF-36 v2 is a self-administered, health-related quality of life (QoL) metric. It is a 36-item questionnaire designed to measure 8 domains of functional health status and well-being: physical functioning (PF), role-physical (RP), bodily pain (BP), general health (GH) perceptions, vitality (VT), social functioning (SF), role-emotional (RE), and mental health (MH). Each domain is scored from 0 (poorer health) to 100 (better health); higher scores represent better health. Change from Baseline was calculated as the post-Baseline score minus the Baseline score. Missing post-Baseline data were imputed using the LOCF method. The scores were analyzed using an ANCOVA model, adjusting for Baseline sub-scale score, treatment, and country. Positive changes from Baseline indicate improvement.|Baseline, Month 6, Month 12, and every 6 months after discontinuation of study treatment for 24 months (up to a maximum of 3 study years)|ITT Population (primary analysis [conducted in 2011]). Only those participants available (represented as n=X, X in the category titles) at the specified time points were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
727167|NCT00374322|Secondary|Change From Baseline in SF-36 v2 Scores for the Mental Component Summary (MCS)|The SF-36 v2 is a self-administered, health-related quality of life (QoL) metric. It is a 36-item questionnaire designed to measure 8 domains of functional health status and well-being: physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. Each domain is scored from 0 (poorer health) to 100 (better health).The MCS score is a summary score representing overall mental health, which is derived from the 8 domain scores. As with each domain score, the MCS score ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as the post-Baseline score minus the Baseline score. Missing post-Baseline data were imputed using the LOCF method. The scores were analyzed using an ANCOVA model adjusting for Baseline sub-scale score, treatment, and country. Positive changes from Baseline indicate improvement.|Baseline, Month 6, Month 12, and every 6 months after discontinuation of study treatment for 24 months (up to a maximum of 3 study years)|ITT Population (primary analysis [conducted in 2011]). Only those participants available (represented as n=X, X in the category titles) at the specified time points were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
727168|NCT00374322|Secondary|Change From Baseline in Short Form-36 Version 2 (SF-36 v2) Scores for the Physical Component Summary (PCS)|The SF-36 v2 is a self-administered, health-related quality of life (QoL) metric. It is a 36-item questionnaire designed to measure 8 domains of functional health status and well-being: physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. Each domain is scored from 0 (poorer health) to 100 (better health).The PCS score is a summary score representing overall physical health, which is derived from the 8 domain scores. As with each domain score, the PCS score ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as the post-Baseline score minus the Baseline score. Missing post-Baseline data were imputed using the last observation carried forward (LOCF) method. The scores were analyzed using an analysis of covariance (ANCOVA) model, adjusting for Baseline sub-scale score, treatment, and country. Positive changes from Baseline indicate improvement.|Baseline, Month 6, Month 12, and every 6 months after discontinuation of study treatment for 24 months (up to a maximum of 3 study years)|ITT Population (primary analysis [conducted in 2011]). Only those participants available (represented as n=X, X in the category titles) at the specified time points were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
727169|NCT00374322|Secondary|Number of Participants With Any Recurrence of the Initial Disease, Contralateral Breast Cancer, or Death (Disease-free Survival [DFS])|DFS=interval between the date of randomization and the date of the first occurrence of an objective disease recurrence, a second primary cancer, or death from any cause. The date of the event is the earliest date of the occurrence of any of the following: local recurrence (LR) following mastectomy; LR in ipsilateral breast following lumpectomy; regional recurrence; distant recurrence and contralateral breast cancer, including ductal carcinoma in situ; or death from any cause without a prior event. Participants who started additional anti-cancer adjuvant therapy prior to the recurrence of their disease were to be censored. Participants who did not withdraw from the study and did not experience a specified event or death were to be censored (follow-up ongoing) at the last visit date available at which progression was assessed.|From the date of randomization until the date of the first occurrence of an objective disease recurrence, contralateral breast cancer, or death from any cause (assessed up to 6 years)|ITT Population. Data for the end-of-study analysis (conducted in 2013) are reported.||Participants|||Number
727170|NCT00374322|Secondary|Modified Disease-free Survival (MDFS)|Modified disease recurrence=interval between the date of randomization and the date of the first occurrence of an objective disease recurrence, contralateral breast cancer, or death from any cause. The date of the event=the earliest date of the occurrence of any of the following events: local recurrence following mastectomy; local recurrence in ipsilateral breast following lumpectomy; regional recurrence; distant recurrence; contralateral breast cancer, including DCIS; death from any cause without a prior event. MDFS was not calculated; data are presented as the number of participants with any recurrence of the initial disease, contralateral breast cancer, or death (disease-free survival) in the subsequent outcome measure table.|From the date of randomization until the date of the first occurrence of an objective disease recurrence, contralateral breast cancer, or death from any cause (assessed up to 6 years)||||||
727171|NCT00374322|Secondary|Number of Participants With CNS Recurrence|The number of participants experiencing a CNS recurrence was summarized.|From the date of randomization until the date of the first occurrence of a CNS recurrence (assessed up to 6 years [1 year of treatment and 5 years of follow-up; median of 5.3 years for final analysis])|ITT Population. Data for the end-of-study analysis (conducted in 2013) are reported.||Participants|||Number
727172|NCT00374322|Secondary|Time to Central Nervous System (CNS) Recurrence|Time to CNS recurrence is defined as the interval between the date of randomization and the date of the occurrence of a CNS recurrence if noted as part of the participant's first recurrence. Time to CNS recurrence was not calculated; data are presented as the number of participants with CNS recurrence in the subsequent outcome measure table.|From the date of randomization until the date of the first occurrence of a CNS recurrence (assessed up to 6 years [1 year of treatment and 5 years of follow-up; median of 5.3 years for final analysis])||||||
727225|NCT00362128|Primary|Number of Participants With Cardiovascular Risk Factors||4 years|||participants|||Number
727173|NCT00374322|Secondary|Percentage of Participants With the Indicated Period of Distant Recurrence-free Survival (Time to Distant Recurrence)|Distant recurrence (metastatic disease) is defined as a tumor in any area of the body not including those defined as local or regional recurrence. Sites of distant recurrence include: skin, subcutaneous tissue, and lymph nodes (excluding those described for local and regional recurrence); bone marrow; skeletal; lungs and pleural; ascites and pleural effusions; liver and other viscera; and central nervous system (CNS). Time to distant recurrence is defined as the interval between the date of randomization and the date of the first occurrence of a distant recurrence.|From the date of randomization until the date of the first occurrence of a distant recurrence (assessed up to 6 years; 1 year of treatment and 5 years of follow-up [median of 5.3 years for final analysis])|ITT Population. Data for the primary analysis (conducted in 2011) are reported.||Percentage of participants|||Number
727174|NCT00374322|Secondary|Percentage of Participants With the Indicated Period of Recurrence-free Survival (Time to First Recurrence)|Recurrence is defined as experiencing a recurrence of initial disease or contralateral breast cancer after randomization. Time to first recurrence is defined as the interval between the date of randomization and the date of the first occurrence of an objective disease recurrence or contralateral breast cancer. Time to first recurrence included the first occurrence at one of the following sites as an event: local recurrence following mastectomy; local recurrence in ipsilateral breast following lumpectomy; regional recurrence; distant recurrence; contralateral breast cancer, including ductal carcinoma in situ (DCIS).|From the date of randomization until the date of the first occurrence of an objective disease recurrence or contralateral breast cancer (assessed up to 6 years; 1 year of treatment and 5.3 years of follow-up [median of 5 years for final analysis])|ITT Population. Data for the primary analysis (conducted in 2011) are reported.||Percentage of participants|||Number
727175|NCT00374322|Secondary|Number of Participants Who Died (Overall Survival)|Overall Survival (OS) is defined as the time from randomization until death from any cause. Data are presented as the number of participants who died. For participants who did not die, time to death was censored at the last date the participant was known to be alive.|From the date of randomization until death from any cause (assessed up to 6 years; 1 year of treatment and 5 years of follow-up [median of 5.3 years for final analysis])|ITT Population. Data for the primary analysis (conducted in 2011) are reported.||Participants|||Number
727176|NCT00374322|Primary|Number of Participants (Par.) With Any Recurrence of the Initial Disease, Second Primary Cancer, Contralateral Breast Cancer, or Death (Disease-free Survival [DFS])|DFS=interval between the date of randomization and the date of the first occurrence of an objective disease recurrence, a second primary cancer, or death from any cause. The date of the event is the earliest date of the occurrence of any of the following: local recurrence (LR) following mastectomy; LR in ipsilateral breast following lumpectomy; regional recurrence; distant recurrence; contralateral breast cancer, including ductal carcinoma in situ; other second primary cancer (excluding squamous or basal cell carcinoma of the skin, melanoma in situ, carcinoma in situ of the cervix, or lobular carcinoma in situ of the breast); death from any cause without a prior event. Par. who started additional anti-cancer adjuvant therapy prior to the recurrence of their disease were to be censored. Par. who did not withdraw from the study and did not experience a specified event or death were to be censored (follow-up ongoing) at the last visit date available at which progression was assessed.|From randomization until date of the first occurrence of an objective disease recurrence, a second primary cancer, or death from any cause (assessed up to 6 years; 1 year of treatment, 5 years of follow-up [median of 5.3 years for final analysis])|Intent-to-Treat (ITT) Population: all randomized participants who received at least one dose of randomized treatment (lapatinib or placebo). Data for the end-of-study analysis (conducted in 2013) are reported.||Participants|||Number
727177|NCT00374335|Primary|Presence of Hepatic Hemangiomas on Abdominal Ultrasound|The number of participants with cutaneous infantile hemangiomas (1-4 cutaneous hemangiomas, greater than 5 cutaneous hemangiomas, or at least one large cutaneous hemangioma) who were found to have hepatic hemangiomas on abdominal ultrasound|2 years||||||
727178|NCT00374335|Secondary|Risk Factors Associated With the Development of Hepatic Hemangiomas|Which participants with cutaneous infantile hemangiomas (1-4 cutaneous hemangiomas, greater than 5 cutaneous hemangiomas, or at least 1 large cutaneous hemangioma) were found to have hepatic hemangiomas on abdominal ultrasound|2 years|||participants|||Number
727179|NCT00374335|Primary|Frequency of Hepatic Hemangiomas Identified on Abdominal Ultrasound|The number of participants with cutaneous infantile hemangiomas (1-4 cutaneous hemangiomas, greater than 5 cutaneous hemangiomas, or at least one large cutaneous hemangioma) who were found to have hepatic hemangiomas on abdominal ultrasound|2 years|||participants|||Number
727180|NCT00361569|Secondary|Safety and Tolerability of DR-2041 (Synthetic Conjugated Estrogens, A)|Any adverse event reported from the beginning of the 28-day screening through the subject's last report.|Up to Week 12|All randomized subjects who received at least one dose of study medication||Participants|||Number
727181|NCT00361569|Primary|Mean Change in Maturation Index|Change= Week 12 maturation index -baseline maturation index. Matuation index was calculated using the following equation: Maturation Index = (% Parabasal cells * 0) + (% Intermediate Cells * 0.5) + (% Superficial Cells * 1.0)|Baseline to Week 12|Modifed Intent-to-Treat: All subjects who met study protocol requirements at baseline for all 3 primary efficacy inclusion criteria, who were randomized to treatment, received at least 1 dose of study drug, for whom there were a baseline assessment and at least 1 post-randomization assessment of VVA consisting of all 3 co-primary efficacy endpoints||Index||Standard Error|Least Squares Mean
727182|NCT00361569|Primary|Mean Change in Vaginal pH|Change= Week 12 vaginal pH - Baseline vaginal pH|Baseline to Week 12|Modifed Intent-to-Treat: All subjects who met study protocol requirements at baseline for all 3 primary efficacy inclusion criteria, who were randomized to treatment, received at least 1 dose of study drug, for whom there were a baseline assessment and at least 1 post-randomization assessment of VVA consisting of all 3 co-primary efficacy endpoints||pH||Standard Error|Least Squares Mean
727208|NCT00362115|Secondary|Change From Baseline in the 24-36-Hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 24-36-hour mean systolic blood pressure measured at week 8 relative to the 12-hour mean measured at baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-36-hour mean is the average of all measurements recorded from 24 to 36 hours after dosing; the 12-hour mean is the average of the first 12 hours after dosing.|Baseline and Week 8.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
727183|NCT00361569|Primary|Mean Change in the Symptom Identified by the Patient to be Most Bothersome|Change= Week 12 score - Baseline Score. The most bothersome symptom was derived from the subject self-assessment of vaginal atrophy, which consisted of 5 questions concerning severity of symptoms graded on a scale of 0-3(none, mild, moderate or severe) or 7 for not applicable.|Baseline to Week 12|Modifed Intent-to-Treat: All subjects meeting study protocol requirements at baseline for all 3 primary efficacy inclusion criteria, randomized to treatment, received at least 1 dose of study drug, and had a baseline assessment and at least 1 post-randomization assessment of vulvovaginal atrophy consisting of all 3 co-primary efficacy endpoints||Scores on a scale||Standard Error|Least Squares Mean
727184|NCT00361595|Secondary|Change in Serum N-propeptide Type 1 Collagen (P1NP) (at Day 10 and Months 2, 6, 9 and 12)|Change in serum n-propeptide type 1 collagen (P1NP) (at day 10 and months 2, 6, 9 and 12. 12 month values reported based on 12 month duraton of zolendronic acid effect.|12 months|||mcg/ml||Standard Deviation|Mean
727185|NCT00361595|Secondary|Change in Serum C-telopeptide Type 1 Collagen (CTX) (at Day 10 and Months 2, 6, 9 and 12)|Change in serum c-telopeptide type 1 collagen (CTX) (at day 10 and months 2, 6, 9 and 12. 12 month values reported based on 12 month duraton of zolendronic acid effect.|12 months|||ng/ml||Standard Deviation|Mean
727186|NCT00361595|Secondary|Change in Bone Density (Grams/cm^2) at the Total Hip at 6 and 12 Months|Change in bone density (grams/cm^2) at the total hip at 6 and 12 months. 12 month reported based on usual interval for bone density follow-up in clinical practice.|6 months and 12 months|||grams/cm^2||Standard Deviation|Mean
727187|NCT00361595|Primary|Change in Lumbar Spine BMD (Bone Mineral Density) in g/cm^2 From Baseline to Month 12 Relative to Baseline as Measured by DXA (Dual-energy X-ray Absorptiometry)||Baseline and 12 months|||grams/cm^2||Standard Deviation|Mean
727188|NCT00361634|Secondary|Difference Between Percent Change in IAUC From Days -28 to 1 and Days 1 to 85|Difference in percent change between the synovial initial area under the contrast-time curve (IAUC) for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) from Day 1 to Day 85 and from Day -28 to Day 1|Day -28 to Day 85|Full Analysis Set, composed of all participants who had a baseline and at least one post-baseline measurement. Only participants with available data are included in the analysis.||percent change||Standard Deviation|Mean
727189|NCT00361634|Secondary|Difference Between Percent Change in IAUC From Days -28 to 1 and Days 1 to 57|Difference in percent change between the synovial initial area under the contrast-time curve (IAUC) for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) from Day 1 to Day 57 and from Day -28 to Day 1|Day -28 to Day 57|Full Analysis Set, composed of all participants who had a baseline and at least one post-baseline measurement. Only participants with available data are included in the analysis.||percent change||Standard Deviation|Mean
727190|NCT00361634|Secondary|Difference Between Percent Change in IAUC From Days -28 to 1 and Days 1 to 29|Difference in percent change between the synovial initial area under the contrast-time curve (IAUC) for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) from Day 1 to Day 29 and from Day -28 to Day 1|Day -28 to Day 29|Full Analysis Set, composed of all participants who had a baseline and at least one post-baseline measurement. Only participants with available data are included in the analysis.||percent change||Standard Deviation|Mean
727191|NCT00361634|Secondary|Difference Between Percent Change in Ktrans From Days -28 to 1 and Days 1 to 85|Difference in percent change between synovial transfer constant (Ktrans) for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) from study day 1 to study day 85 and from study day -28 to study day 1|Day -28 to Day 85|Full Analysis Set, composed of all participants who had a baseline and at least one post-baseline measurement. Only participants with available data are included in the analysis.||percent change||Standard Deviation|Mean
727192|NCT00361634|Secondary|Difference Between Percent Change in Ktrans From Days -28 to 1 and Days 1 to 57|Difference in percent change between synovial transfer constant (Ktrans) for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) from study day 1 to study day 57 and from study day -28 to study day 1.|Day -28 to Day 57|Full Analysis Set, composed of all participants who had a baseline and at least one post-baseline measurement. Only participants with available data are included in the analysis.||percent change||Standard Deviation|Mean
727193|NCT00361634|Secondary|Difference Between Percent Change in Ktrans From Days -28 to 1 and Days 1 to 29|Difference in percent change between synovial transfer constant (Ktrans) for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) from study day 1 to study day 29 and from study day -28 to study day 1.|Day -28 to Day 29|Full Analysis Set, composed of all participants who had a baseline and at least one post-baseline measurement. Only participants with available data are included in the analysis.||percent change||Standard Deviation|Mean
727194|NCT00361634|Secondary|Percent Change in Synovial Volume From Days 1-85|Percent change in the synovial volume for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) of the wrist from Day 1 to Day 85. Synovial volume was evaluated by image subtraction from the T1-weighted images pre-and post-administration of the contrast agent.|Day 1 to Day 85|Full Analysis Set, composed of all participants who had a baseline and at least one post-baseline measurement. Only participants with available data are included in the analysis.||Percent change||Standard Deviation|Mean
727195|NCT00361634|Secondary|Percent Change in Synovial Volume From Days 1-57|Percent change in the synovial volume for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) of the wrist from Day 1 to Day 57. Synovial volume was evaluated by image subtraction from the T1-weighted images pre-and post-administration of the contrast agent.|Day 1 to Day 57|Full Analysis Set, composed of all participants who had a baseline and at least one post-baseline measurement. Only participants with available data are included in the analysis.||Percent change||Standard Deviation|Mean
727196|NCT00361634|Primary|Percent Change in the Synovial Initial Area Under the Contrast-Time Curve (IAUC) From Days 1-85|Percent change in the synovial initial area under the contrast-time curve (IAUC) for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) of the wrist from Day 1 to Day 85. IAUC reflects the contrast distribution volume (extravascular extracellular space) in addition to contrast delivery and transport across the vascular endothelium. An IAUC value of zero indicates the absence of disease (ie, no leakage of the contrast agent into the synovial volume); therefore, an increase in this parameter indicates worsening disease (ie, greater permeability of the synovial membrane).|Day 1 to Day 85|Full Analysis Set, composed of all participants who had a baseline and at least one post-baseline measurement. Only participants with available data are included in the analysis.||Percent change||Standard Deviation|Mean
727197|NCT00361634|Primary|Percent Change in the Synovial Initial Area Under the Contrast-Tme Curve (IAUC) From Days 1-57|Percent change in the synovial initial area under the contrast-time curve (IAUC) for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) of the wrist from Day 1 to Day 57. IAUC reflects the contrast distribution volume (extravascular extracellular space) in addition to contrast delivery and transport across the vascular endothelium. An IAUC value of zero indicates the absence of disease (ie, no leakage of the contrast agent into the synovial volume); therefore, an increase in this parameter indicates worsening disease (ie, greater permeability of the synovial membrane).|Day 1 to Day 57|Full Analysis Set, composed of all participants who had a baseline and at least one post-baseline measurement. Only participants with available data are included in the analysis.||Percent change||Standard Deviation|Mean
727198|NCT00361634|Primary|Percent Change in Synovial Initial Area Under the (Contrast-time) Curve (IAUC) From Days 1-29|Percent change in the synovial initial area under the contrast-time curve (IAUC) for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) of the wrist from Day 1 to Day 29. IAUC reflects the contrast distribution volume (extravascular extracellular space) in addition to contrast delivery and transport across the vascular endothelium. An IAUC value of zero indicates the absence of disease (ie, no leakage of the contrast agent into the synovial volume); therefore, an increase in this parameter indicates worsening disease (ie, greater permeability of the synovial membrane).|Day 1 to Day 29|Full Analysis Set, composed of all participants who had a baseline and at least one post-baseline measurement. Only participants with available data are included in the analysis.||Percent change||Standard Deviation|Mean
727199|NCT00361634|Primary|Percent Change in Synovial Transfer Constant (Ktrans) From Days 1-85|Percent change in transfer constant (Ktrans) for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) of the wrist from study day 1 to study day 85. Ktrans reflects contrast delivery (capillary blood flow) and transport across the vascular endothelium (capillary permeability-surface area product), with the dominant factor depending on whether delivery is flow or permeability limited. A Ktrans value of zero indicates the absence of disease (ie, no leakage of the contrast agent into the synovial volume); therefore, increases in this parameter indicates worsening disease (ie, greater permeability of the synovial membrane).|Day 1 to Day 85|Full Analysis Set, composed of all participants who had a baseline and at least one post-baseline measurement. Only participants with available data are included in the analysis.||Percent change||Standard Deviation|Mean
727200|NCT00361634|Primary|Percent Change in Synovial Transfer Constant (Ktrans) From Days 1-57|Percent change in transfer constant (Ktrans) for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) of the wrist from study day 1 to study day 57. Ktrans reflects contrast delivery (capillary blood flow) and transport across the vascular endothelium (capillary permeability-surface area product), with the dominant factor depending on whether delivery is flow or permeability limited. A Ktrans value of zero indicates the absence of disease (ie, no leakage of the contrast agent into the synovial volume); therefore, an increase in this parameter indicates worsening disease (ie, greater permeability of the synovial membrane).|Day 1 to Day 57|Full Analysis Set, composed of all participants who had a baseline and at least one post-baseline measurement. Only participants with available data are included in the analysis.||Percent change||Standard Deviation|Mean
727201|NCT00361634|Secondary|Percent Change in Synovial Volume From Days 1-29|Percent change in the synovial volume for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) of the wrist from Day 1 to Day 29. Synovial volume was evaluated by image subtraction from the T1-weighted images pre-and post-administration of the contrast agent.|Day 1 to Day 29|Full Analysis Set, composed of all participants who had a baseline and at least one post-baseline measurement. Only participants with available data are included in the analysis.||Percent change||Standard Deviation|Mean
727202|NCT00361634|Primary|Percent Change in Synovial Transfer Constant (Ktrans) From Days 1-29|Percent change in transfer constant (Ktrans) for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) of the wrist from study day 1 to study day 29. Ktrans reflects contrast delivery (capillary blood flow) and transport across the vascular endothelium (capillary permeability-surface area product), with the dominant factor depending on whether delivery is flow or permeability limited. A Ktrans value of zero indicates the absence of disease (ie, no leakage of the contrast agent into the synovial volume); therefore, an increase in this parameter indicates worsening disease (ie, greater permeability of the synovial membrane).|Day 1 to Day 29|Full Analysis Set, composed of all participants who had a baseline and at least one post-baseline measurement. Only participants with available Day 29 data are included in the analysis.||Percent change||Standard Deviation|Mean
727203|NCT00361972|Secondary|Log Change in Tumor Necrosis Factor (TNF) Alpha Measurement|Change in TNF alpha cytokine expression from bronchoalveolar lavage aspirate samples between lansoprazole and placebo groups, measured in log picograms per milliliter (log (pg/mL)) units, pre- and post-intervention.|Baseline and 6 weeks|||log (pg/mL)||Inter-Quartile Range|Median
727204|NCT00361972|Primary|Change in Lymphocyte Count|Change in mean lymphocyte count in bronchus intermedius biopsies between lansoprazole and placebo groups, measured in lymphocytes per square millimeter. Overall mean differences were compared (post-intervention mean lymphocyte count minus pre-intervention mean lymphocyte count) between the two intervention groups.|Baseline and 6 weeks|||Lymphocytes per square millimeter||Standard Deviation|Mean
727205|NCT00362115|Secondary|Change From Baseline in the 34-36-Hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 34-36-hour mean diastolic blood pressure measured at week 8 relative to the 10-12-hour mean measured at baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-36-hour mean is the average of all measurements recorded from 34 to 36 hours after dosing; the 10-12-hour mean is the average from these 2 hours after dosing.|Baseline and Week 8.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
727206|NCT00362115|Secondary|Change From Baseline in the 34-36-Hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 34-36-hour mean systolic blood pressure measured at week 8 relative to the 10-12-hour mean measured at baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-36-hour mean is the average of all measurements recorded from 34 to 36 hours after dosing; the 10-12-hour mean is the average from these 2 hours after dosing.|Baseline and Week 8|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
727226|NCT00362180|Secondary|Percent Change in Total Cholesterol From Baseline to Day 99|Samples were taken following an overnight fast.|Day 26 and Day 99|Full analysis set with last observation carried forward.||percent change||Inter-Quartile Range|Median
727209|NCT00362115|Secondary|Change From Baseline in the Nighttime (12 am to 6 am) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 8.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
727210|NCT00362115|Secondary|Change From Baseline in the Nighttime (12 am to 6 am) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean systolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 8.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
727211|NCT00362115|Secondary|Change From Baseline in Daytime (6am to 10 pm) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 8.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
727212|NCT00362115|Secondary|Change From Baseline in Daytime (6am to 10 pm) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean systolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 8.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
727213|NCT00362115|Secondary|Change From Baseline in the Trough (22-24-hr) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough mean diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 8.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
727214|NCT00362115|Secondary|Change From Baseline in the Trough (22-24-hr) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough mean systolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 8|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
727215|NCT00362115|Secondary|Change From Baseline in the 10-12-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 10 to 12-hour mean diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 10-12-hour mean is the average of all measurements recorded after dosing during these 2 hours.|Baseline and Week 8.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
727216|NCT00362115|Secondary|Change From Baseline in the 10-12-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 10 to 12-hour mean systolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 10-12-hour mean is the average of all measurements recorded after dosing during these 2 hours.|Baseline and Week 8.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
727217|NCT00362115|Secondary|Change From Baseline in the 12-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 12-hour mean diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 8.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
727218|NCT00362115|Secondary|Change From Baseline in the 12-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 12-hour mean systolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 8.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
727219|NCT00362115|Secondary|Change From Baseline in 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 8.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
727220|NCT00362115|Secondary|Change From Baseline in 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean systolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 8.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
727221|NCT00362115|Secondary|Change From Baseline in Standing Clinic Diastolic Blood Pressure.|The change in standing clinic diastolic blood pressure measured at final visit or week 8 relative to baseline. Diastolic blood pressure is the arithmetic mean of the 3 trough standing diastolic blood pressure measurements.|Baseline and Week 8.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
727222|NCT00362115|Secondary|Change From Baseline in Standing Clinic Systolic Blood Pressure.|The change in standing clinic systolic blood pressure measured at final visit or week 8 relative to baseline. Systolic blood pressure is the arithmetic mean of the 3 trough standing systolic blood pressure measurements.|Baseline and Week 8.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
727227|NCT00362180|Secondary|Baseline Total Cholesterol|Samples were taken following an overnight fast.|Baseline|Full analysis set||mg/wk||Inter-Quartile Range|Median
727232|NCT00362180|Primary|Change From Baseline in Liver Triglyceride (TG) Content As Measured by Magnetic Resonance Spectroscopy (MRS)|Localized proton MRS was used to quantify liver TG concentration. All MRS imaging of the liver was performed using the same 1.5T scanner. The instructions were to cover the entire liver (from just above the dome to just below the inferior tip) using a qualified imaging technique (Yokoo, 2009, Radiology). Liver fat quantification was performed by determining the liver fat fraction (%) derived from MRS using selected Regions of Interest (ROI). The analyst typically looked for the branching of the right portal vein and mapped slices from one scan to the next. There were typically 2 ROIs in the right lobe and 1 in the left lobe. Magnetic resonance spectroscopy imaging ROIs between different scans were selected using anatomical landmarks for both time points.|Baseline, Day 26, Day 99|Full analysis set. In Cohort E: Placebo, Day 99 N=11 instead of 10 because participant did not have a post treatment MRS by Day 26.||percentage of total liver content||Full Range|Median
727233|NCT00362232|Secondary|Treatment-emergent Major Bleedings Per Safety Population.|Blinded, adjudicated assessments of all available information (eg, anesthesia and surgery reports, laboratory results, number of transfusions, autopsy report)|from start of double-blind study medication to last dose of double-blind study medication plus two days. The average duration of double-blind treatment was 12 days in each treatment group (safety population).|The safety population comprised those subjects who received at least 1 dose of study drug.||percentage of participants|||Number
727234|NCT00362232|Secondary|Incidence of the Composite Endpoint That Results From Major VTE by Substituting All Cause Mortality for VTE-related Death Per Modified Intent to Treat of Major VTE Population.|Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography|Up to 16 days after surgery|A subject was considered valid for the MITT analysis if the subject was valid for the safety analysis, had undergone the appropriate surgery, and had an adequate assessment of thromboembolism||percentage of participants|||Number
727235|NCT00362232|Secondary|Incidence of the Composite Endpoint That Results From Major VTE by Substituting All Cause Mortality for VTE-related Death Per Protocol of Major VTE Population.|Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography|Up to 16 days after surgery|The PP population included subjects who were valid for the modified intent to treat (MITT) population, had an adequate assessment of thromboembolism that, in case of a positive finding, was done not later than 36 hours after stop of study drug, and had no major protocol deviations||percentage of participants|||Number
727236|NCT00362232|Secondary|Incidence of the Composite Endpoint That Results From the Primary Endpoint by Substituting VTE Related Death for All Death Per Modified Intent to Treat Population.|Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography|Up to 16 days after surgery|A subject was considered valid for the MITT analysis if the subject was valid for the safety analysis, had undergone the appropriate surgery, and had an adequate assessment of thromboembolism||percentage of participants|||Number
727237|NCT00362232|Secondary|Incidence of the Composite Endpoint That Results From the Primary Endpoint by Substituting VTE Related Death for All Death Per Protocol Population.|Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography|Up to 16 days after surgery|The PP population included subjects who were valid for the modified intent to treat (MITT) population, had an adequate assessment of thromboembolism that, in case of a positive finding, was done not later than 36 hours after stop of study drug, and had no major protocol deviations||percentage of participants|||Number
727238|NCT00362232|Secondary|The Composite Endpoint Comprising Major VTE and Treatment-emergent Major Bleeding Per Subjects Valid for Analysis of Net Clinical Benefit|Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography, anesthesia and surgery reports, number of transfusions|Up to 47 days after surgery|The net clinical benefit population comprised all subjects either valid for MITT analysis of major VTE or who showed treatment-emergent major bleeding.||percentage of participants|||Number
727239|NCT00362232|Secondary|Incidence of Symptomatic VTE During Follow-up Per Modified Intent to Treat Population.|Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography|Up to 47 days after surgery|A subject was considered valid for the MITT analysis if the subject was valid for the safety analysis, had undergone the appropriate surgery, and had an adequate assessment of thromboembolism||percentage of participants|||Number
727240|NCT00362232|Secondary|Incidence of Symptomatic VTE During Follow-up Per Protocol Population.|Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography|Up to 47 days after surgery|The PP population included subjects who were valid for the modified intent to treat (MITT) population, had an adequate assessment of thromboembolism that, in case of a positive finding, was done not later than 36 hours after stop of study drug, and had no major protocol deviations||percentage of participants|||Number
727241|NCT00362232|Secondary|Incidence of DVT (Proximal, Distal) Per Modified Intent to Treat Population.|Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography|Up to 16 days after surgery|A subject was considered valid for the MITT analysis if the subject was valid for the safety analysis, had undergone the appropriate surgery, and had an adequate assessment of thromboembolism||percentage of participants|||Number
727242|NCT00362232|Secondary|Incidence of DVT (Proximal, Distal) Per Protocol Population.|Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography|Up to 16 days after surgery|The PP population included subjects who were valid for the modified intent to treat (MITT) population, had an adequate assessment of thromboembolism that, in case of a positive finding, was done not later than 36 hours after stop of study drug, and had no major protocol deviations||percentage of participants|||Number
727243|NCT00362232|Secondary|Incidence of Symptomatic VTE (DVT, PE) Per Modified Intent to Treat Population.|Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography|Up to 16 days after surgery|A subject was considered valid for the MITT analysis if the subject was valid for the safety analysis, had undergone the appropriate surgery, and had an adequate assessment of thromboembolism||percentage of participants|||Number
727244|NCT00362232|Secondary|Incidence of Symptomatic VTE (DVT, PE) Per Protocol Population.|Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography|Up to 16 days after surgery|The PP population included subjects who were valid for the modified intent to treat (MITT) population, had an adequate assessment of thromboembolism that, in case of a positive finding, was done not later than 36 hours after stop of study drug, and had no major protocol deviations||percentage of participants|||Number
727245|NCT00362232|Secondary|Incidence of the Composite Endpoint Comprising Proximal DVT, Non-fatal PE and VTE- Related Death (Major VTE) Per Modified Intent to Treat Population of Major VTE.|Blinded, adjudicated assessment of bilateral venography, clinical signs of deep vein thrombosis (DVT) and pulmonary embolism (PE), ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography|Up to 16 days after surgery|A subject was considered valid for the MITT analysis if the subject was valid for the safety analysis, had undergone the appropriate surgery, and had an adequate assessment of thromboembolism||percentage of participants|||Number
727246|NCT00362232|Secondary|Incidence of the Composite Endpoint Comprising Proximal DVT, Non-fatal PE and VTE- Related Death (Major VTE) Per Protocol Population of Major VTE|Blinded, adjudicated assessment of bilateral venography, clinical signs of deep vein thrombosis (DVT) and pulmonary embolism (PE), ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography|Up to 16 days after surgery|The PP population included subjects who were valid for the modified intent to treat (MITT) population, had an adequate assessment of thromboembolism that, in case of a positive finding, was done not later than 36 hours after stop of study drug, and had no major protocol deviations.||percentage of participants|||Number
727247|NCT00362232|Primary|Composite Endpoint of Total VTE i.e.: Any DVT (Proximal and/or Distal), Non Fatal PE, Death of All Causes Per Modified Intent to Treat Population.|Blinded, adjudicated assessment of bilateral venography, clinical signs of deep vein thrombosis (DVT) and pulmonary embolism (PE), ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography|Up to 16 days after surgery|A subject was considered valid for the MITT analysis if the subject was valid for the safety analysis, had undergone the appropriate surgery, and had an adequate assessment of thromboembolism||Percentage of participants|||Number
727248|NCT00362232|Primary|Composite Endpoint of Total Venous Thrombo Embolism (VTE) i.e.: Any Deep Vein Thromboembolism (DVT) (Proximal and/or Distal), Non Fatal Pulmonary Embolism (PE), Death of All Causes Per Protocol Population|Blinded, adjudicated assessment of bilateral venography, clinical signs of deep vein thrombosis (DVT) and pulmonary embolism (PE), ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography|Up to 16 days after surgery|The primary efficacy analysis was based on the per protocol (PP) population and included subjects who were valid for the modified intent to treat (MITT) population, had an adequate assessment of thromboembolism that, in case of a positive finding, was done not later than 36 hours after stop of study drug, and had no major protocol deviations.||Percentage of participants|||Number
727249|NCT00362297|Secondary|Number of Herpes Recurrences, Defined Clinically as >=1 Successive Day on Which Genital Lesions Are Present, in Participants Treated With High-dose Acyclovir as Compared to Once-daily Valacyclovir.||15 weeks||||||
727250|NCT00362297|Secondary|Frequency of Lesional Shedding From the Genital Tract as Measured by PCR, Calculated Using a Per Day Shedding Rate in Participants Treated With High-dose Acyclovir as Compared to Once-daily Valacyclovir.||15 weeks||||||
727251|NCT00362297|Secondary|Frequency of Subclinical Shedding From the Genital Tract as Measured by PCR, Calculated Using a Per-day Shedding Rate in Participants Treated With High-dose Acyclovir as Compared to Once-daily Valacyclovir.||15 weeks||||||
727252|NCT00362297|Primary|Frequency of HSV-2 Total Shedding From the Genital Tract as Measured by PCR, Calculated Using a Per-day Shedding Rate in Participants Treated With High-dose Acyclovir as Compared to Once-daily Valacyclovir.|Participants were treated with both interventions in a cross-over study design. Shedding rates on each drug arm per participant were compared by Poisson regression.|15 weeks|Participants who did not collect at least one swab on each arm of the cross-over were excluded from analysis.||percentage of swabs with HSV detected|||Number
727268|NCT00362401|Primary|Intensity (Highness) of the Sound From Mechanical Heart Valves|The measurements took place in a Bioacoustic laboratory. The total background noise was 9 dB(A). The valve closing sounds were recorded by a microphone placed 5 cm above the patient’s chest. This sound was pre-amplified, amplified, filtered and stored on an instrumentation recorder for later off-line analysis.|10.06.2007|Patients with a mechanical heart valve prosthesis recruited from a cardiology outpatient clinic following heart valve replacement at the same hospital between three months and four years prior to this investigation.||dB (decibel)||Standard Deviation|Mean
727253|NCT00362336|Secondary|Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV)|Solicited Injection Site Reactions: Pain, Erythema, Swelling, and Extensive swelling of vaccinated limb. Solicited System Reactions: Fever (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability. Grade 3 was defined as: Pain, crying when injected limb is moved or the movement reduced; Erythema and Swelling, ≥ 5 cm; Fever, temperature ≥ 39.0ºC; Vomiting, ≥ 6 episodes/24 hours or requiring parenteral hydration; Crying, > 3 hours; Somnolence, sleeping most of the time or difficulty to wake up; Anorexia, refusing ≥ 3 feeds or refusing most feeds/meals; and Irritability, inconsolable.|Day 0 up to 7 post-booster vaccination|Solicited reactions were assessed in all participants who received at least 1 dose of investigational or reference vaccine, according to the vaccine actually received (Safety Analysis Population).||Participants|||Number
727254|NCT00362336|Secondary|Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV).|Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited System Reactions: Fever (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability. Grade 3 was defined as: Pain - crying when injected limb is moved or the movement reduced; Erythema and Swelling - ≥ 5 cm; Fever - temperature ≥ 39.0ºC; Vomiting - ≥ 6 episodes/24 hours or requiring parenteral hydration; Crying abnormal - > 3 hours; Somnolence - sleeping most of the time or difficulty to wake up; Anorexia - refusing ≥ 3 feeds or refusing most feeds/meals; and Irritability - inconsolable.|Day 0 up to Day 7 post each dose|Solicited reactions were assessed in all participants who received at least 1 dose of investigational or reference vaccine, according to the vaccine actually received - Safety Analysis Population.||Participants|||Number
727255|NCT00362336|Secondary|Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV|Anti-Hepatitis B (Hep B) was measured by enhanced chemiluminescence detection, anti-Haemophilus influenzae type b (PRP) by Farr type radio immunoassay, anti-Diphtheria by toxin neutralization assay, anti-Tetanus (T) by indirect enzyme-linked immunosorbent assay (ELISA), anti-Poliovirus types 1, 2, and 3 by neutralization assay, and anti-Pertussis toxoid (PT) and anti-Filamentous hemagglutinin (FHA) by ELISA.|Day 540 pre-booster and Day 570, post-booster|GMTs were assessed in all participants who did not have any protocol violation that might have interfered with primary criteria evaluation (Per-Protocol Population).||Titers||95% Confidence Interval|Geometric Mean
727256|NCT00362336|Secondary|Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV|Antibodies were measured by the following methods: anti-Hepatitis B (Hep B) by enhanced chemiluminescence detection, anti-Haemophilus influenzae type b (PRP) by Farr type radio immunoassay, anti-Diphtheria by toxin neutralization assay, anti-Tetanus by indirect enzyme-linked immunosorbent assay (ELISA), anti-poliovirus types 1, 2, and 3 by neutralization assay. Persistence and response were defined as a titer ≥ 10 mIU/mL for anti-Hep B, ≥ 0.15 µg/mL for anti-PRP, ≥ 0.01 IU/mL for anti-Diphtheria and anti-Tetanus, ≥ 8 (1/dil) for anti-Poliovirus, and ≥ 4 EU/mL for anti-PT and anti-FHA.|Day 540 pre-booster and Day 570 post-booster|Seroprotection was assessed in all participants who did not have any protocol violation that might have interfered with primary criteria evaluation (Per-Protocol Population).||Participants|||Number
727257|NCT00362336|Secondary|Geometric Mean Titers (GMTs) of Antibodies After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV)|Anti-Hepatitis B (Hep B) was measured by enhanced chemiluminescence detection, anti-Haemophilus influenzae type b (Hib) by Farr type radio-immunoassay, anti-Diphtheria by toxin neutralization assay, anti-Tetanus by indirect enzyme-linked immunosorbent assay (ELISA), anti-Poliovirus types 1, 2, and 3 by neutralization assay, and anti-Pertussis toxoid (PT) and anti-Filamentous hemagglutinin (FHA) by ELISA.|Day 42 before Dose 1 and 1 month post-Dose 3|GMTs were assessed in all participants who did not have any protocol violation that might have interfered with primary criteria evaluation (Per-Protocol Population).||Titers||95% Confidence Interval|Geometric Mean
727258|NCT00362336|Secondary|Number of Participants Attaining Other Seroprotection and Seroconversion Titers After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV)|Anti-Hepatitis B (Hep B) was measured by enhanced chemiluminescence detection, anti-Haemophilus influenzae type b (Hib) by Farr type radio immunoassay, anti diphtheria by toxin neutralization assay, anti-Tetanus (T) by indirect enzyme-linked immunosorbent assay (ELISA), and anti-Pertussis toxoid (PT) and anti-Filamentous hemagglutinin (FHA) by ELISA. Seroprotection was defined as a titer ≥ 100 mIU/mL for anti-Hep B; ≥ 1 µg/mL for anti-PRP; ≥ 0.1 IU/mL (Level 1) and ≥ 1.0 IU/mL (Level 2) for anti-Diphtheria and anti-Tetanus. Seroconversion for anti-PT and anti-FHA was a ≥ 4-fold increase from baseline.|1 month post-Dose 3|Seroprotection was assessed in all participants who did not have any protocol violation that might have interfered with primary criteria evaluation (Per-Protocol Population).||Participants|||Number
727259|NCT00362336|Primary|Number of Participants With Seroprotection After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV)|Antibodies were measured by the following methods: anti-Hepatitis B (Hep B) by enhanced chemiluminescence detection, anti-Haemophilus influenzae type b (Hib) by Farr type radio immunoassay, anti-Diphtheria (D) by toxin neutralization assay, anti-Tetanus (T) by indirect enzyme-linked immunosorbent assay (ELISA), and anti-Poliovirus types 1, 2, and 3 by neutralization assay. Seroprotection was defined as the following antibody titers: Anti-Tetanus ≥ 0.01 International Unit (IU)/mL; Anti-Diphtheria ≥ 0.01 IU/mL; Anti-Hepatitis B ≥ 10 mIU/mL; Anti-Polyribosyl ribitol phosphate ≥ 0.15 µg/mL; Anti-polio 1, 2, and 3 ≥ 8 (1/dil).|1 month post-Dose 3|Seroprotection was assessed in all participants who did not have any protocol violation that might have interfered with primary criteria evaluation (Per-Protocol Population).||Participants|||Number
727260|NCT00362375|Secondary|Knowledge of HIV Test||current||||||
727261|NCT00362375|Secondary|Condom Use Self-efficacy||current||||||
727262|NCT00362375|Secondary|HIV Knowledge||current||||||
727263|NCT00362375|Secondary|HIV Testing and Receipt of Results|Percentage of women who reported testing for HIV infection and received their test results during the past 3 months|Past 3 months|Based on the number of women who provided data at the 3-month follow-up||Percent|||Number
727269|NCT00362414|Secondary|Trail Making B Test|Measure of memory and executive function where one is asked to connect dots with letters and numbers alternating between number and letter and connecting dots consecutively. Test taker is allowed 4 minutes to connect the dots with a maximum score of 25 for all dots connected correctly.|3 mo.|||correct connections||Full Range|Median
727270|NCT00362414|Secondary|Trail Making A Test|Measure of memory and executive function where one is asked to connect dots consecutively based on the number of the dot. Test taker is allowed 2 minutes to connect the dots with a maximum score of 25 for all dots connected correctly.|3 mo|||correct connections||Full Range|Median
727271|NCT00362414|Secondary|Infarct Volume Using Anatomical MRI|Measurement of infarct volume and percent change from baseline to Day 90.|3 mo|||percent change||Standard Error|Mean
727272|NCT00362414|Secondary|Barthel Index|Measure of disability in terms of performance of activities of daily living (ADL). The scores range from 0-100 with a higher score being associated with a higher level of independence.|3 mo|||Units on a scale||Full Range|Median
727273|NCT00362414|Secondary|Geriatric Depression Scale Short Form|Measure of depression done as a self-report. It is a series of 15 questions designed to be a screen for depression. The scores range from 0-15 with a higher score being more indicative of depression.|3 mo|||Units on a scale||Full Range|Median
727274|NCT00362414|Secondary|NIH Stroke Scale|Measure of global impairment post stroke. It includes 11 items to examine levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. The scoring scale is between 0-42 where a higher score is indicative of a more severe stroke.|3 mo|||Units on a scale||Full Range|Median
727275|NCT00362414|Secondary|Line Cancellation Test|Measure of spatial neglect where patients must cross out lines placed in a random orientation. Missed lines may indicate areas of spatial neglect.|3 mo|||ratio of canceled lines on each side||Full Range|Median
727276|NCT00362414|Secondary|Boston Naming Test|Measure of aphasia or other language disturbance caused by stroke or other dementing disorders. It consists of 60 line drawings graded in difficulty in which patients are to name each picture.|3 mo|||Units on a scale||Full Range|Median
727277|NCT00362414|Secondary|Fugl-Meyer Leg Scale|"Measure of leg motor impairment with three subsections which are Proximal, Hip/Knee, and Speed/Coordination. The scale ranges from 0-34 with a higher score being better. A score of 34 is considered normal."|3 mo.|||Units on a scale||Full Range|Median
727278|NCT00362414|Secondary|Fugl-Meyer Arm Scale|"Fugl-Meyer arm scale is a measurement scale of the upper body with three sections being Proximal, Wrist/Hand, and Coordination/Speed. The scores can range from 0-66 with a higher score being better. A score of 66 is considered normal with no impairments."|3 mo|||Units on a scale||Full Range|Median
727279|NCT00362414|Secondary|Action Research Arm Test|"The Action Research Arm Test is a 19 item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point ordinal scale ranging from: 3: Performs test normally 2: Completes test, but takes abnormally long or has great difficulty 1: Performs test partially 0: Can perform no part of test. Total scores range from 0-57 points, a higher score being better with 57 being considered normal."|3 mo|This number (9) is the total # subjects who could complete the test at all study time points; some subjects were unable to complete this test at one of the time points, especially the acute stroke assessment.||Units on a scale||Full Range|Median
727280|NCT00362414|Primary|Mortality|attributable to experimental intervention|3 mo|||participants|||Number
727281|NCT00362414|Primary|Morbidity|attributable to experimental intervention|3 mo|||participants|||Number
727282|NCT00362414|Primary|Safety|Safety through Day 90 was assessed through adverse event reporting, serial examinations, blood testing, and a leg vein Doppler at Day 42. Number of participants who experienced adverse events, had abnormality in serial examinations, blood testing, and a leg vein Doppler at Day 42.|3 mo|||participants|||Number
727283|NCT00362440|Secondary|Body Composition (Fat Mass)||At the end of each 3 month intervention|||kg||Standard Error|Mean
727284|NCT00362440|Secondary|Cholesterol Levels||At the end of each 3 month intervention|||mg/dl||Standard Error|Mean
727285|NCT00362440|Primary|Insulin Resistance (HOMA Index)||At the end of each 3 month intervention|||units on a scale||Standard Error|Mean
727286|NCT00362453|Secondary|Change in Medical Outcome Study Short Form 36 (SF-36) Mental Component|Health related quality of life assessments were made using the SF-36. The SF-36 measures 8 domains: physical functioning, role-physician, bodily pain, general health, vitality, social function, emotional health and mental health. The Mental Component of the SF-36 had scores that ranged from 0 to 100; 0 equals worst health state. Change: Higher numbers reported here indicate more improvement in condition from baseline.|baseline to 12, 24, 48 weeks|||units on a scale||95% Confidence Interval|Mean
727287|NCT00362453|Secondary|Change in Medical Outcome Study Short Form 36 (SF-36) Physical Component From Baseline to 12, 24, and 48 Weeks.|Health related quality of life assessments were made using the SF-36. The SF-36 measures 8 domains: physical functioning, role-physician, bodily pain, general health, vitality, social function, emotional health and mental health. The Physical Component of the SF-36 had scores that ranged from 0 to 100; 0 equals worst health state. Change: Higher numbers reported here indicate more improvement in condition from baseline.|baseline, 12, 24, 48 weeks|||units on a scale||95% Confidence Interval|Mean
727288|NCT00362453|Secondary|Change in Self-Efficacy Scale From Baseline to 12, 24, and 48 Weeks.|"Self-efficacy is important for individuals to adopt and maintain a program of regular physical activity. The patient rates his/her confidence of being physically active in different types of situations on a 5-item scale with responses ranging from not at all confident to extremely confident. The total score is coputed by calculating the average of all 5 questions. A higher score indicates greater self-efficacy. Higher numbers reported here indicate more improvement from baseline."|baseline to 12, 24, 48 weeks|||units on a scale||95% Confidence Interval|Mean
727289|NCT00362453|Secondary|Change in Center for Epidemiology Studies Depression Index (CES-D)From Baseline to 12, 24, and 48 Weeks.|The CES-D was used to assess depressive symptoms. It included a 20-item Likert-type scale with scores ranging from 0 to 60. Higher scores indicated greater dysphoria. Negative numbers reported here indicate improvement in condition from baseline. (So -1 indicates a 1-point improvement from baseline.)|baseline to 12, 24, 48 weeks|||units on a scale||95% Confidence Interval|Mean
728444|NCT00380250|Secondary|Month 3 Abdominal Bloating Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|Change from baseline for month 3|ITT with LOCF||Scale score||Standard Deviation|Mean
727290|NCT00362453|Secondary|Change in Standing Balance From Baseline to 12, 24, and 48 Weeks.|The standing balance test included tandem, semi-tandem, side-by-side, and one-legged stands. Patients were asked to maintain each position for 30 seconds. For each task, the research staff first demonstrated the task, asked the patient if they felt comfortable and ready and then supported the patient while positioning themselves. One point was given if they exceeded 30 seconds and none if they could not or did not attempt the test. Higher numbers reported here indicate more improvement from baseline.|baseline to 12, 24, 48 weeks|Note: Data for only 19 patients in Attention Control group was analyzed for 48-week timepoint due to availability of data.||units on a scale||95% Confidence Interval|Mean
727291|NCT00362453|Secondary|Change in 6 Minute Walk Test From Baseline to 12, 24, and 48 Weeks.|The 6 minute walk test is a reliable measure of functional exercise capacity. Patients were asked to walk as fast and as far as possible within the 6-minute period and were accompanied by the research staff using a wheel measure that measured distance covered in inches and convereted to yards; higher scores indicated improved state. Higher numbers reported here indicate more improvement from baseline.|baseline to 12, 24, 48 weeks|Note: Data for only 18 patients from Tai chi group was analyzed for 12 week timepoint. Data for 19 patients from the Attention Control group was analyzed at 48 week timepoint.||yards||95% Confidence Interval|Mean
727292|NCT00362453|Secondary|Change in Timed Chair Stand From Baseline to 12, 24, and 48 Weeks.|Timed stand tests measure the time taken to complete ten full stands from a sitting position. Patients began the chair stand seated with their arms folded across their chests, then rose to a standing position and sat back down with their back against the back rest of the chair. The test was completed when the patient stood for the tenth repetition. Chair stand time was measured in seconds, with lower scores indicating improved state. Negative numbers reported here indicate improvement in condition from baseline. (So -10 indicates a 10-second improvement from baseline.)|baseline to 12, 24, 48 weeks|Note: Data for only 18 participants in the Attention Control group was analyzed for the 48-week timepoint to do availability of data.||seconds||95% Confidence Interval|Mean
727293|NCT00362453|Secondary|Change in Physician Global Knee Pain Assessment Visual Analogue Scale (VAS)From Baseline to 12, 24, and 48 Weeks.|The study physician who was blinded to group assignment completed a global knee pain assessment VAS with scores ranging from 0 to 10cm; 0 equals no pain. Negative numbers reported here indicate improvement in condition from baseline. (So -10 indicates a 10-point improvement from baseline.)|baseline to 12, 24, 48 weeks|Note: Data for only 19 participants in the Attention Control group was analyzed at 48 Weeks due to lack of available data.||cm||95% Confidence Interval|Mean
727294|NCT00362453|Secondary|Change in Patient Global Knee Pain Assessment Visual Analogue Scale (VAS)|Participants completed a self-reported knee-specific global pain VAS with scores ranging from 0 to 10 centimeters (cm); 0 equals no pain. Negative numbers reported here indicate improvement in condition from baseline. (So -10 indicates a 10-point improvement from baseline.)|baseline to 12, 24, 48 weeks|||cm||95% Confidence Interval|Mean
727295|NCT00362453|Secondary|Change in WOMAC Pain Scores From Baseline to 24 and 48 Weeks.|The WOMAC is a validated, self-administered instrument specifically designed to evaluate knee and hip OA. The WOMAC was administered to the participants at baseline, 12, 24 and 48 weeks. The pain subscale score range was 0-500mm, with higher scores indicating more severe disease. Negative numbers reported here (change in subscale score) indicate improvement in condition from baseline. (So -200 indicates a 200-point improvement from baseline.)|baseline to 24, 48 weeks|The 12-Week WOMAC scores are listed under Primary Outcome. The 24-Week and 48-Week scores are listed as Secondary Outcomes.||mm||95% Confidence Interval|Mean
727296|NCT00362453|Secondary|Change in WOMAC Stiffness From Baseline to 12, 24, and 48 Weeks.|The WOMAC is a validated, self-administered instrument specifically designed to evaluate knee and hip OA. The stiffness subscale has a score range 0-200mm, with higher scores indicating more severe disease. Negative numbers reported here (change in subscale score) indicate improvement in condition from baseline. (So -100 indicates a 100-point improvement from baseline.)|baseline to 12, 24, 48 weeks|||mm||95% Confidence Interval|Mean
727297|NCT00362453|Secondary|Change in WOMAC Function From Baseline to 12, 24, and 48 Weeks.|The WOMAC is a validated, self-administered instrument specifically designed to evaluate knee and hip OA. The function subscale had a score range 0-1700mm, with higher scores indicating more severe disease. Negative numbers reported here (change in subscale score) indicate improvement in condition from baseline. (So -200 indicates a 200-point improvement from baseline.)|from baseline to 12, 24, 48 weeks|||mm||95% Confidence Interval|Mean
727298|NCT00362453|Primary|Change in the Western Ontario and McMaster University Index (WOMAC) Pain Subscale Between Baseline and 12 Weeks|WOMAC scale range: 0 millimeters (no pain) to 500 millimeters (severe pain), ordinal. Change: score at 12 weeks minus score at baseline. Negative numbers reported here indicate improvement in condition from baseline. (So -100 indicates a 100-point improvement from baseline.)|between baseline and 12 weeks.|We analyzed the data on an intent-to-treat basis.||mm||95% Confidence Interval|Mean
727299|NCT00362466|Secondary|Best MMR Rates|MMR is defined as a 3-log reduction in BCR-ABL gene transcripts from a standardized baseline. Reductions in BCR-ABL transcripts on logarithmic scale are calculated based on the absolute values expressed as % of ratio of BCR-ABL gene transcripts to the control gene. In this study, ABL was used as the control gene.|throughout study|This analysis was not done. This study was terminated due to insufficient enrollment.||participants|||Number
727300|NCT00362466|Secondary|Duration of CCyR and MMR|Duration of CCyR computed for subjects with CCyR as best response; measured from time the criteria are first met for CCyR until date of progression or death. Duration of MMR computed for subjects with MMR as best response; measured from time the criteria are first met for MMR until date the MMR was first lost, disease progression or death.|Throughout the study|This analysis was not done. This study was terminated due to insufficient enrollment.||months|||Number
727301|NCT00362466|Secondary|Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs|An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a patient or clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.|From 2 weeks prior to randomization through Month 36. At least every 4 weeks until all study-related toxicities resolve to baseline, stabilize, or are deemed irreversible.|All treated participants||events|||Number
727302|NCT00362466|Secondary|Progression Free Survival (PFS)|PFS=time from randomization until progression or death. Participants who died without progression=progression on date of death. Participants who neither progressed nor died were censored on date of last hematologic assessment. Participants who did not receive study treatment and neither progressed nor died were censored on date of randomization.|at 36 months|This analysis was not done. This study was terminated due to insufficient enrollment.||participants|||Number
727303|NCT00362466|Secondary|Estimate Time to MMR and CCyR|Time to MMR is defined as the time from first treatment dose until measurement criteria are first met for MMR. Time to MMR is computed only for subjects who achieved a MMR. Time to CCyR is defined as the time from first treatment dose until measurement criteria are first met for CCyR. Time to CCyR is computed only for subjects who achieved a CCyR.|throughout the study|This analysis was not done. This study was terminated due to insufficient enrollment.||months|||Number
727304|NCT00362466|Secondary|CCyR Rates|CyR is based on the prevalence of Ph+ metaphases among cells in metaphase on a bone marrow sample. The criteria for CCyR is 0% Ph+ metaphases among cells in a bone marrow sample.|Month 3, Month 12, Month 24 and Month 36|This analysis was not done. This study was terminated due to insufficient enrollment.||Participants|||Number
727305|NCT00362466|Secondary|Major Molecular Response (MMR) Rates|MMR is defined as a 3-log reduction in BCR-ABL gene transcripts from a standardized baseline. Reductions in BCR-ABL transcripts on logarithmic scale are calculated based on the absolute values expressed as percent of ratio of BCR-ABL gene transcripts to the control gene. In this study,ABL was used as the control gene.|Month 3, Month 6, Month 12, Month 24 and Month 36|This analysis was not done. This study was terminated due to insufficient enrollment.||participants|||Number
727306|NCT00362466|Primary|Complete Cytogenetic Response (CCyR) Rate at Month 6|Cytogenetic Response (CyR) is based on the prevalence of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase on a bone marrow sample. The criteria for CCyR is 0% Ph+ metaphases among cells in a bone marrow sample.|Month 6|This analysis was not done. This study was terminated due to insufficient enrollment.||participants|||Number
727307|NCT00362609|Secondary|Half Life|Half life is the time required for half the quantity of absorbed drug to be metabolized or eliminated by normal biological processes. Half life was estimated from population pharmacokinetic (PK) modeling.|1 day|Single dose PK Valid-For-Efficacy patients (defined as those without any major protocol violations who completed the single-dose PK determinations and took the test article on the date the PK samples were taken) who also had measurable concentrations over the period of observation. 2 poor metabolizers were excluded from this analysis.||hours||Standard Deviation|Mean
727308|NCT00362609|Secondary|Apparent Oral Clearance (Cl/F)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling.|1 day|Single dose PK Valid-For-Efficacy patients (defined as those without any major protocol violations who completed the single-dose PK determinations and took the test article on the date the PK samples were taken) who also had measurable concentrations over the period of observation. 2 poor metabolizers were excluded from this analysis.||L/hr/kg||Standard Deviation|Mean
727309|NCT00362609|Secondary|Area Under the Concentration-time Curve (AUC)|AUC is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption. AUC was estimated from population pharmacokinetic (PK) modeling.|Baseline to 24 hours post dose on Day 1|Single dose PK Valid-For-Efficacy patients (defined as those without any major protocol violations who completed the single-dose PK determinations and took the test article on the date the PK samples were taken) who also had measurable concentrations over the period of observation. 2 poor metabolizers were excluded from this analysis.||ng*hr/mL||Standard Deviation|Mean
727310|NCT00362609|Primary|Variance of Oral Bioavailability|Samples were divided between 2 groups for each dose: Group A at baseline, 2, 8, 18 hours; Group B at baseline, 1, 4, 12 hours to reduce the number of blood draws per infant. The variance of oral bioavailability was assessed to determine if further PK assessment was appropriate. It would be considered highly variable if the square root of the sum of the standard deviation squares of the area under the concentration-time curves from time zero to the time of the last quantifiable concentration (AUCT) for group A and Group B divided by the sum of the mean AUCT for group A and Group B was >1.2.|1 day|Single dose PK Valid-For Efficacy patients (defined as those without any major protocol violations who completed the single-dose PK determinations and taken the test article on the date the PK samples were taken). 2 poor metabolizers were excluded from this analysis.||ratio|||Number
727311|NCT00362648|Secondary|Asia - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]|Induction of postdose 3 SNA response (Number of subjects with ≥ 3 fold rise in antibody titer)|14 days following the 3rd vaccination|Per Protocol Population||Subjects|||Number
727312|NCT00362648|Secondary|Africa - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]|Induction of postdose 3 SNA response (Number of subjects with ≥ 3 fold rise in antibody titer)|14 days following the 3rd vaccination|"Per Protocol Population
*N analyzed for Serotype P1A[8] is 188"||Subjects|||Number
727313|NCT00362648|Primary|Occurrence of Severe Clinical Rotavirus Disease Caused by Any Rotavirus Serotype More Than 14 Days Following the Third Dose||At least 14 days following the third vaccination|Per Protocol Population||Subjects|||Number
727314|NCT00362817|Secondary|Quality of Life Assessment|To determine the impact of treatment on quality of life.|up to 2 years|Quality of Life Assessment was not done.|||||
727315|NCT00362817|Secondary|The Incidence and Severity of Centeral Nervous System (CNS) Toxicities|To determine the incidence and severity of CNS toxicity in patients treated with intra-arterial carboplatin and oral temozolomide.|up to 24 weeks|||patients|||Number
727316|NCT00362817|Secondary|Determine the Cause of Death of Patients After Treatment|To determine the cause of death (i.e., CNS tumor versus systemic disease progression) in patients after treatment.|up to 1 year|||patients|||Number
727317|NCT00362817|Secondary|Determine the Overall Survival of Patients|From the time of protocol initiation|up to 64 weeks|||weeks||Full Range|Mean
727442|NCT00375505|Secondary|Change in Inhibin A and Inhibin B From Baseline to Month 24|Change in Inhibin A and Inhibin B from baseline to month 24|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.||pg/ml||Standard Deviation|Mean
727318|NCT00362817|Secondary|Analyze Patients Time to Progression|"Responses to treatment was determined by comparing new enhanced MRI scans with those obtained at the previous evaluation (i.e., 2 treatment cycles ago) or with the pre-IA chemotherapy baseline scan, if it is the first follow-up MRI scan during treatment.
MRI is the neuro-imaging modality of choice, since it is more accurate than CT for small tumors, multiple tumors, and tumors in the posterior fossa.58 The methodology used (techniques and equipment) must be identical for all scans. Lesions should be measured as the largest diameter seen on scan and the largest diameter perpendicular to that dimension."|up to 60 weeks|||weeks||Full Range|Mean
727319|NCT00362817|Primary|Affects of Response Rate of Chemotherapy With Intra-arterial Carboplatin and Oral Temozolomide|Response was evaluated by MRI Criteria (MacDonald Criteria). The MacDonald criteria for determining tumor progression is determined through assessing the increase in size of an enhancing tumor on consecutive MRI scans and clinical assessment. Complete response occurs when there is a disappearance of all enhancing tumor on consecutive MRI scans at least one month apart. Partial response occurs at a >50% reduction in size of enhancing tumor on consecutive MRI scans at least one month apart. Progressive disease occurs when there is a >25% increase in size of enhancing tumor on consecutive MRI scans. Stable disease occurs in all remaining situations.|up to 1 year|||percentage of patients with response|||Number
727320|NCT00362882|Secondary|Progression-free Survival||6 months||||||
727321|NCT00362882|Secondary|Disease Control Rate|Disease control rate was defined as the rate of partial response (PR) plus stable disease (SD; for at least 2 cycles).|Up to 4 years|||percentage of participants|||Number
727322|NCT00362882|Secondary|Overall Survival|Will be estimated using the product-limit method of Kaplan and Meier.|From first day of treatment to time of death due to any cause, up to 4 years|||Months||95% Confidence Interval|Median
727323|NCT00362882|Primary|Overall Response Rate for PS-341 and Docetaxel Given in Two Sequences and to Decide Whether This Combination Warrants Further Study|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT, MRI or X-ray: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Up to 4 years|||percentage of participants|||Number
727324|NCT00363038|Primary|Average Bruise Change|Mean change in bruising level detected by dermatologist rater on Visual Analogue Scale at 2 weeks compared with baseline for each of the four agents (Petrolatum USP, Vitamin K and retinol ointment, Vitamin K ointment, Arnica ointment). When responding to a VAS item, respondents specify the bruise severity by indicating a position along a continuous line between two end-points (0 and 10, 10 being the most bruised).|Baseline and 2 weeks|||Units on a Scale||Standard Deviation|Mean
727325|NCT00363051|Secondary|Effect of Octreotide Depot on the Trough Concentrations of Everolimus|The effect of Octreotide Depot on the trough concentrations of everolimus was assessed at Cycle 1 Day 15.|Cycle 1 Day 1, Cycle 2 Day 1|Full Analysis Set (FAS) is consisted of all patients who received at least one dose of everolimus. Patients with Octreotide Depot pharmacokinetic samples, with nonzero concentration, at Cycle 1 Day 1 or Cycle 2 Day 1 were included.||ng/ml||Standard Deviation|Mean
727326|NCT00363051|Secondary|Everolimus Trough Level Determination by Pharmacokinetics Parameter in Both Strata (Stratum 1 and 2)|For all patients in both strata, a blood sample for everolimus trough level determination will be collected immediately prior to the everolimus administration on Cycle 1 Day 15, Cycle 2 Day 1, and every month thereafter. A treatment cycle was defined as 28 days of consecutive daily treatment with everolimus and treatment continued until tumor progression. It is critical that patients not take their daily everolimus dose before the sample is drawn.|Cycle 1 Day 15|Full Analysis Set (FAS) is consisted of all patients who received at least one dose of everolimus. Patients with everolimus pharmacokinteic samples, with nonzero concentration, at Cycle 1 Day 15 were included||ng/ml||Standard Deviation|Mean
727327|NCT00363051|Secondary|Time to Overall Survival (OS) (Stratum 2)|"Overall survival measures the time of survival , with any response or disease progression, until death. The OS is defined as the time from date of start of treatment to date of death due to any cause.
If a patient is not known to have died, survival was censored at the date of last contact. In each treatment stratum, the Kaplan-Meier estimate of the overall survival function was constructed."|from randomisation to dates of disease progression, death from any cause, reported between day of first patient randomised, 26 June 2006, until cut-off date 13 April 2012|The full analysis set consisted of all patients who received at least one dose of everolimus.||months||95% Confidence Interval|Median
727328|NCT00363051|Secondary|Time to Overall Survival (OS)(Stratum 1)|"Overall survival measures the time of survival , with any response or disease progression, until death. The OS is defined as the time from date of start of treatment to date of death due to any cause.
If a patient is not known to have died, survival was censored at the date of last contact. In each treatment stratum, the Kaplan-Meier estimate of the overall survival function was constructed."|from randomisation to dates of disease progression, death from any cause, reported between day of first patient randomised, 26 June 2006, until cut-off date 13 April 2012|The full analysis set consisted of all patients who received at least one dose of everolimus.||months||95% Confidence Interval|Median
727329|NCT00363051|Secondary|Time to Progression Free Survival (PFS) Per Central Radiology Review (Stratum 2)|"Progression free survival (PFS) is defined as the time from randomization to the date of first documented disease progression or death from any cause. The Kaplan-Meier estimate of the PFS survival function was constructed.
Median PFS was obtained and displayed along with 95% confidence intervals."|from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 26 June 2006, until cut-off date 13 September 2010|The full analysis set (FAS) consisted of all patients who received at least one dose of everolimus.||Months||95% Confidence Interval|Median
727330|NCT00363051|Secondary|Time to Progression Free Survival (PFS) Per Central Radiology Review (Stratum 1)|"Progression free survival (PFS) is defined as the time from randomization to the date of first documented disease progression or death from any cause. The Kaplan-Meier estimate of the PFS survival function was constructed.
Median PFS was obtained and displayed along with 95% confidence intervals."|from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 26 June 2006, until cut-off date 13 September 2010|The full analysis set (FAS) consisted of all patients who received at least one dose of everolimus.||Months||95% Confidence Interval|Median
727331|NCT00363051|Secondary|Number of Participants With Adverse Events (AEs), Death, Serious Adverse Events (SAEs) [Stratum 2]|Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.|on or after the day of the first intake of study treatment to starting no later than 28 days after study treatment discontinuation, at least every month|The safety population consists of all patients who received at least one dose of everolimus and had at least one post-baseline safety assessment.||Participants|||Number
727332|NCT00363051|Secondary|Number of Participants With Adverse Events (AEs), Death, Serious Adverse Events (SAEs)[Stratum 1]|Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.|on or after the day of the first intake of study treatment to starting no later than 28 days after study treatment discontinuation, at least every month|The safety population consists of all patients who received at least one dose of everolimus and had at least one post-baseline safety assessment.||Participants|||Number
727333|NCT00363051|Secondary|Objective Response Rate: Percentage of Participants With Best Over All Response of Complete Response or Partial Response by Central Radiology Review (Stratum 2) Based on Response Evaluation Criteria in Solid Tumors (RECIST)|Objective response rate was defined by RECIST criteria: Partial response (PR) must have ≥ 30% decrease in the sum of longest diameter of all target lesions, from the baseline sum. Complete response (CR) must have disappearance of all target and non-target lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments within 4 weeks. Progression = 20% increase in the sum of longest diameter of all target lesions, from smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions.|from date of randomization/start of treatment until first documented response confirmed 4 weeks later (at least 3 months)|Full Analysis Set (FAS) was consisted of all patients who received at least one dose of everolimus.||percentage of participants||95% Confidence Interval|Number
727334|NCT00363051|Secondary|Duration of Overall Response (Stratum 2) Based on Response Evaluation Criteria in Solid Tumors (RECIST)- Central Radiology Review|"Duration of overall response applies only to patients whose best overall response was complete response (CR) or partial response (PR):
Complete Response (CR) = at least two determinations of CR at least 4 weeks apart before progression.
Partial response (PR) = at least two determinations of PR or better at least 4 weeks apart before progression.
Progression = 20% increase in the sum of the longest diameter of all target lesions, from the smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions"|from date of first documented confirmed response to time to progression, at least 3 months|Very low number of patients demonstrated a partial response, the median duration of response as per central review has not been calculated.|||||
727335|NCT00363051|Secondary|Duration of Overall Response (Stratum 1) Based on Response Evaluation Criteria in Solid Tumors (RECIST)- Central Radiology Review|"Duration of overall response applies only to patients whose best overall response was complete response (CR) or partial response (PR):
Complete Response (CR) = at least two determinations of CR at least 4 weeks apart before progression.
Partial response (PR) = at least two determinations of PR or better at least 4 weeks apart before progression.
Progression = 20% increase in the sum of the longest diameter of all target lesions, from the smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions"|from date of first documented confirmed response to time to progression, at least 3 months|Full Analysis Set (FAS) consisted of all patients who received at least one dose of everolimus. Only those patients whose best overall response was complete response (CR) or partial response (PR) were included in this analysis.||Months||95% Confidence Interval|Median
727336|NCT00363051|Primary|Objective Response Rate: Percentage of Participants With Best Over All Response of Complete Response or Partial Response by Central Radiology Review (Stratum 1) Based on Response Evaluation Criteria in Solid Tumors (RECIST)|Objective response rate was defined by RECIST criteria: Partial response (PR) must have ≥ 30% decrease in the sum of longest diameter of all target lesions, from the baseline sum. Complete response (CR) must have disappearance of all target and non-target lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments within 4 weeks. Progression = 20% increase in the sum of longest diameter of all target lesions, from smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions.|from date of randomization/start of treatment until first documented response confirmed 4 weeks later( at least 3 months)|The full analysis set (FAS) consisted of all patients who received at least one dose of everolimus.||percentage of participants||95% Confidence Interval|Number
727337|NCT00363077|Secondary|Number of Subjects With Any and Related Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related = SAE considered by the investigator to have a causal relationship to study vaccination.|During the entire study period (from Day 0 to Day 29)|The analysis was performed on the Total Vaccinated cohort, on all subjects with the documented dose.||subjects|||Number
727338|NCT00363077|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented everyday activities. Related = unsolicited AE assessed by the investigator as related to the vaccination.|During the 30-day (Days 0-29) post vaccination period|The analysis was performed on the Total Vaccinated cohort, on all subjects with the documented dose.||subjects|||Number
727339|NCT00363077|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.|Assessed solicited general symptoms were arthralgia, fatigue, fever [axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, muscle aches and shivering. Any = incidence of a particular symptom regardless of grade intensity or relationship with the study vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0°C. Related = symptom considered by the investigator to have a causal relationship to study vaccination.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, on all subjects with the documented dose.||subjects|||Number
727340|NCT00363077|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.|Assessed solicited local symptoms were ecchymosis, pain, redness and swelling at injection site. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling/ecchymosis = redness/swelling/ecchymosis spreading beyond 50 millimeters (mm) of the injection site. All solicited local symptoms were considered to be related to vaccination.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, on all subjects with the documented dose.||subjects|||Number
727341|NCT00363077|Secondary|Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.|The geometric mean was calculated for CD8 T-cells (per million CD8 T-cells) producing at least two different cytokines (All Doubles), at least CD40L, at least INF gamma (IFN-g), at least IL2 and at least TNF alpha (TNF-α).|At Days 0 and 21|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine, for whom administration site of study vaccine was known, who did not receive a vaccine forbidden in the protocol and for whom immunogenicity data were available.||cytokine-positive cells/million cells||Standard Deviation|Geometric Mean
727342|NCT00363077|Secondary|Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.|The geometric mean was calculated for CD4 T-cells (per million CD4 T-cells) producing at least two different cytokines (All Doubles), at least CD40L, at least INF gamma (IFN-g), at least IL2 and at least TNF alpha (TNF-α).|At Days 0 and 21|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine, for whom administration site of study vaccine was known, who did not receive a vaccine forbidden in the protocol and for whom immunogenicity data were available.||cytokine-positive cells/million cells||Standard Deviation|Geometric Mean
727343|NCT00363077|Primary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.|At Day 21|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine, for whom administration site of study vaccine was known, who did not receive a vaccine forbidden in the protocol and for whom immunogenicity data were available.||fold increase||95% Confidence Interval|Geometric Mean
727344|NCT00363077|Primary|Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.|A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.|At Day 0 and Day 21|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine, for whom administration site of study vaccine was known, who did not receive a vaccine forbidden in the protocol and for whom immunogenicity data were available.||subjects|||Number
727345|NCT00363077|Primary|Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.|At Day 21|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine, for whom administration site of study vaccine was known, who did not receive a vaccine forbidden in the protocol and for whom immunogenicity data were available.||subjects|||Number
727346|NCT00363077|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia. The seropositivity cut-off assay was 1:10.|At Days 0 and 21|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine, for whom administration site of study vaccine was known, who did not receive a vaccine forbidden in the protocol and for whom immunogenicity data were available.||titers||95% Confidence Interval|Geometric Mean
727347|NCT00363129|Secondary|Duration of Sensory Peripheral Neuropathy ≥ Grade 2|Duration of sensory peripheral neuropathy is the time from onset of grade 2+ neuropathy until the neuropathy is resolved to grade 1 or less during chemotherapy treatment.|6 months post completion of chemotherapy treatment|||days||95% Confidence Interval|Median
727348|NCT00363129|Secondary|Time to Onset of Sensory Peripheral Neuropathy ≥ Grade 2|Time to onset of sensory peripheral neuropathy was calculated using incidences of the adverse event while the patient was receiving chemotherapy.|6 months post completion of chemotherapy treatment|||days||95% Confidence Interval|Median
727349|NCT00363129|Secondary|Percentage of Patients Stopping Chemotherapy Before Treatment is Complete Due to Sensory Peripheral Neuropathy||6 months post completion of chemotherapy treatment|||percentage of participants|||Number
727350|NCT00363129|Secondary|Percentage of Patients Requiring Dose Reductions of Chemotherapy Due to Sensory Peripheral Neuropathy||6 months post completion of chemotherapy treatment|||percentage of patients|||Number
727351|NCT00363129|Primary|Percentage of Patients With Chemotherapy-induced Sensory Peripheral Neuropathy ≥ Grade 2|The chemotherapy-induced sensory peripheral neuropathy utilized the sensory neuropathy item from the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grading: Grade 0=none; grade 1=loss of deep tendon reflexes or paresthesia, including tingling, but not interfering with function; grade 2=objective sensory alteration or paresthesia, including tingling, interfering with function, but not with activities of daily living; grade 3=sensory alteration or paresthesia interfering with activities of daily living; grade 4=permanent sensory losses that are disabling; and grade 5=death.|6 months post completion of chemotherapy treatment|Participants who received at least one dose of assigned therapy.||percentage of participants|||Number
727352|NCT00363142|Secondary|Steady-State Plasma Levels of Amprenavir (APV) and Ritonavir (RTV) Ctau at Weeks 12 and 24|Blood samples were drawn at weeks 12 and 24 to determine the plasma levels of APV and RTV. Concentration at the end of the dosing interval at steady state (Ctau) was presented.|Weeks 12 and 24|PK Parameter (Ctau) Population - Participants in the ITT-E Population who underwent PK sampling and had evaluable APV or RTV Ctau data.||micrograms/mL||95% Confidence Interval|Geometric Mean
727353|NCT00363142|Secondary|Number of Participants With Plasma HIV-1 RNA Genotypic Mutations and Phenotypic Resistance at Time of Virologic Failure Not Present at Baseline|A blood sample was drawn for subjects failing to respond to therapy and the mutations present in the virus were identified. For each subject, the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New mutations that developed at the time of virologic failure were tabulated by drug class.|Baseline through Week 24|Participants in the ITT-E Population who met the virologic failure definition||Participants|||Number
727354|NCT00363142|Secondary|Percent Change From Baseline in Low Density Lipoprotein (LDL) at Week 24|A blood sample was drawn to determine the LDL level at Week 24. Percent change in LDL was defined as (LDL level at Week 24 minus level at baseline) divided by level at baseline x 100%.|Baseline and Week 24|Safety Population||Percent change||Full Range|Median
727355|NCT00363142|Secondary|Percent Change From Baseline in Total Cholesterol, High Density Lipoprotein (HDL), and Triglycerides at Week 24|A blood sample was drawn to determine the cholesterol, HDL, triglycerides levels at Week 24. Percent change in total blood cholesterol, HDL, and triglycerides was defined as (lipid level at Week 24 minus level at baseline) divided by level at baseline x 100%.|Baseline and Week 24|Safety Population||Percent change||Full Range|Median
727356|NCT00363142|Secondary|Number of Participants With Grade 2-4 Adverse Events Occurring in Greater Than or Equal to 2% of Subjects Through Week 24|The number of participants who experienced any grades 2 to 4 adverse events was tabulated. Adverse events were graded based on the Division of Acquired Immunodeficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events.|Baseline through Week 24|Safety Population||participants|||Number
727357|NCT00363142|Secondary|Number of Participants Who Discontinued Treatment Due to Adverse Events Through Week 24|The number of participants who prematurely discontinued study drug due to adverse events was tabulated. Data are summarized by individual adverse event. Adverse events were defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Baseline through Week 24|Safety Population: all randomized subjects who consumed at least one dose of study drug and was analyzed according to the treatment received.||participants|||Number
727358|NCT00363142|Secondary|Median Change From Baseline of CD4+ Cell Count at Week 24, Observed Analysis|A blood sample was drawn to determine the CD4+ cell count at week 24. Change from baseline was defined as CD4+ cell count at Week 24 minus CD4+ cell count at baseline.|Baseline and Week 24|ITT-E Population - Observed Analysis, available data from those subjects who had values at baseline and at Week 24||cells/mm3||Full Range|Median
727359|NCT00363142|Secondary|Mean Change From Baseline of log10 Copies/mL Plasma HIV-1 RNA Levels at Week 24, Observed Analysis|A blood sample was drawn to determine the amount of plasma HIV-1 RNA virus in copies/mL at week 24. Change from baseline was defined as plasma HIV-1 RNA level at Week 24 minus plasma HIV-1 RNA level at baseline.|Baseline and Week 24|ITT-E Population - Observed Analysis, available data from those subjects who had values at baseline and at Week 24||log10 copies/mL||Standard Deviation|Mean
727360|NCT00363142|Secondary|Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 24, TLOVR Analysis|A blood sample was drawn to determine the amount of plasma HIV-1 RNA virus in copies/mL at week 24. The percentage of participants plasma with HIV-1 RNA <50 copies/mL at Week 24 were determined by the TLOVR algorithm with stratification by the six randomization strata.|Week 24|ITT-E Population||Percentage of participants|||Number
727361|NCT00363142|Secondary|Percentage of Participants With Plasma Human Immunodeficiency Virus, Type 1, Ribonucleic Acid (HIV-1 RNA) <400 Copies/mL at Week 24, Time to Loss of Virologic Response (TLOVR) Analysis|A blood sample was drawn to determine the amount of plasma HIV-1 RNA virus in copies/mL at week 24. The percentage of participants with plasma HIV-1 RNA <400 copies/mL at Week 24 were determined by the TLOVR algorithm with stratification by the six randomization strata.|Week 24|ITT-E Population||Percentage of participants|||Number
727362|NCT00363142|Primary|Percentage of Participants Not Meeting the Definition of Virologic Failure at or Prior to Week 24|Virologic failure was defined as two consecutive plasma HIV-1 RNA measures greater than 400 copies/milliliter (mL) separated by at least 2 to 4 week. The percentage of participants not meeting the virologic failure definition was estimated with stratification by the six randomization strata using Mantel-Haenszel weights and the missing/discontinuation equals failure (MD=F) analysis. Missing/discontinuation values were considered failures.|Week 24|Intent-to-Treat Exposed (ITT-E) Population. Subjects who received at least one dose of investigational product.||Percentage of participants|||Number
727375|NCT00363311|Secondary|Change From Baseline in Total FACT-P Score (LOCF)|The FACT-P consists of a total of 39 questions. This scale is divided into five subscales: the Physical Well-Being Subscale (7 questions); the Social/Family Well-Being Subscale (7 questions); the Emotional Well-Being Subscale (6 questions); the Functional Well-Being Subscale (7 questions); and the Prostate Cancer Subscale (12 questions). The questionnaire was administered at baseline and at Months 18 and 36. The score for each of the 39 questions ranges from 0 to 4. The total FACT-P score thus ranges from 0 to156; a higher score indicates better QOL.|Baseline and Months 18 and 36|ITT Population. Only participants with both available baseline and post-baseline values were analyzed at the indicated time points. As the study progressed, participants dropped out of the study or did not complete the questionnaire.||points on a scale||Standard Deviation|Mean
727363|NCT00363168|Secondary|Number of Subjects Experiencing Complications Related to Drug or Its Administration|"Potential complications included:
Deterioration of best-corrected visual acuity by 3 or more lines
Development of intraocular inflammation
Development of elevated intraocular pressure
Development of other ocular or systemic adverse effects.
Subjects were monitored for potential drug-related ocular adverse effects: intraocular inflammation (uveitis), endophthalmitis, central retinal vein occlusion, transient elevation of IOP, acute reduction in the visual acuity, vitreous hemorrhage, injection-site pain, retinal hemorrhage, posterior vitreous detachment, and subconjunctival hemorrhage. Subjects were monitored for potential adverse effects of intravitreal injections: crystalline lens penetration, retinal break and/or detachment, vitreous hemorrhage, inflammation, and infection. Potential systemic adverse effects were captured by monitoring vital functions such as cardiovascular function, nervous system function, renal function, and gastrointestinal function."|12 months after last injection|||participants|||Number
727364|NCT00363168|Secondary|Fluorescein Leakage on Fluorescein Angiography||12 months||||||
727365|NCT00363168|Secondary|Retinal Thickness Measured by Optical Coherence Tomography (OCT)||12 months||||||
727366|NCT00363168|Secondary|Retinal Changes on Funduscopy||12 months||||||
727367|NCT00363168|Primary|Number of Subjects Avoiding 15 or More Letter Loss of Best Corrected Visual Acuity From Baseline to 12 Months on an Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity Chart Measured at 4 Meters.|Visual acuity measured prior to first treatment with ranibizumab and at 12 months following the first treatment were compared for each subject enrolled in the study. The 12 month follow-up visual acuity was subtracted from the baseline visual acuity. Avoiding a 15 or more letter loss in visual acuity was considered a successful outcome.|12 months|||participants|||Number
727368|NCT00363246|Primary|Wheelchair-related Falls|Wheelchair-related falls in 1 year follow-up period.|one year follow-up period|Older veterans who use a wheelchair for their primary means of mobility.||participants|||Number
727369|NCT00363246|Secondary|Injuries From Wheelchair-related Falls|Wheelchair-related falls that resulted in an injury in the one year follow up period|one year follow-up period|Older veterans who use a wheelchair for their primary means of mobility. Analyzed for wheelchair-related fall injury during 1-year follow-up period.||participants|||Number
727370|NCT00363298|Primary|Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) Score|"Yale-Brown Obsessive-Compulsive Scale score by blinded investigator in direct interview. The scale score is the sum of ten items (5 for obsessions and 5 for compulsions: time occupied, degree of interference with functioning, degree of distress, effort to resist the symptom, success in resisting), each rated from 0 to 4, with higher scores indicating more severe OCD. Maximum score is 40. Scores of 14 and below are often described as subclinical, though patients with these scores may still exhibit troubling symptoms and mild to moderate distress. A total score of 8 or less is often termed remission. A decrease in total score from baseline to endpoint of either 25% or 35% is often used as a responder criterion in clinical trials."|At end of week 5, except 1 d-amphetamine subject rated at end of week 2|Subjects who entered the 4-week double-blind study continuation phase, including a last observation carried forward for the one d-amphetamine subject who dropped out of this phase at the end of study week 2 (end of the first week of the continuation phase) for lack of efficacy.||units on a scale||Standard Deviation|Mean
727371|NCT00363298|Primary|Number of Subjects With Clinical Global Impressions Scale - Improvement (CGI-I) Score of 1 or 2|Clinical Global Impressions Scale Improvement Score = 1 (very much improved), or 2 (much improved). Additional possible scale scores are 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse) and 7 (very much worse).|At end of week 5, except 1 d-amphetamine subject rated at end of week 2|Subjects who met the study continuation phase entry criterion of >20% decrease in Y-BOCS score after 1 week of double-blind study medication, and entered this 4-week double-blind continuation phase||participants|||Number
727372|NCT00363311|Secondary|Change From Baseline in FACT-P Social Well-Being Subscale Score (LOCF)|"The FACT-P Social Well-Being subscale is divided into 7 questions, and the participants rated the outcome over the past 7 days; I feel close to my friends., I get emotional support from my family., I get support from my friends., My family has accepted my illness., I am satisfied with family communication about my illness., I feel close to my partner (or the person who is my main support)., I am satisfied with my sex life. The score for each question ranges from 0 to 4; a higher score indicates better social well-being. The total FACT-P score thus ranges from 0 to 156."|Baseline and Months 18 and 36|ITT Population. As the study progressed, participants dropped out of the study or did not complete the questionnaire.||points on a scale||Standard Deviation|Mean
727373|NCT00363311|Secondary|Change From Baseline in FACT-P Physical Well-Being Subscale Score (LOCF)|"The FACT-P Physical Well-Being subscale is divided into 7 questions, and the participants rated the outcome over the past 7 days; I have a lack of energy., I have nausea., Because of my physical condition, I have trouble meeting the needs of my family., I have pain., I am bothered by side effects of treatment., I feel ill., I am forced to spend time in bed. The score for each question ranges from 0 to 4; a lower score indicates better physical well-being. The total FACT-P score thus ranges from 0 to156; a higher score indicates a better quality of life."|Baseline and Months 18 and 36|ITT Population. As the study progressed, participants dropped out of the study or did not complete the questionnaire.||points on a scale||Standard Deviation|Mean
727374|NCT00363311|Secondary|Percent Change From Baseline in Total FACT-P Score (LOCF)|The FACT-P consists of a total of 39 questions. This scale is divided into five subscales: the Physical Well-Being Subscale (7 questions); the Social/Family Well-Being Subscale (7 questions); the Emotional Well-Being Subscale (6 questions); the Functional Well-Being Subscale (7 questions); and the Prostate Cancer Subscale (12 questions). The questionnaire was administered at baseline and at Months 18 and 36. The score for each of the 39 questions ranges from 0 to 4. The total FACT-P score thus ranges from 0 to156; a higher score indicates better QOL.|Baseline and Months 18 and 36|ITT Population. As the study progressed, participants dropped out of the study or did not complete the questionnaire.||points on a scale||Standard Deviation|Mean
727376|NCT00363311|Secondary|Total Functional Assessment of Cancer Therapy Scale, Prostate Module (FACT-P) Score|The FACT-P consists of a total of 39 questions. This scale is divided into five subscales: the Physical Well-Being Subscale (7 questions); the Social/Family Well-Being Subscale (7 questions); the Emotional Well-Being Subscale (6 questions); the Functional Well-Being Subscale (7 questions); and the Prostate Cancer Subscale (12 questions). The score for each of the 39 questions ranges from 0 to 4. The total FACT-P score thus ranges from 0 to156; a higher score indicates better quality of life.|Baseline and Months 18 and 36|ITT Population. As the study progressed, participants dropped out of the study or did not complete the questionnaire.||points on a scale||Standard Deviation|Mean
727377|NCT00363311|Secondary|Change From Baseline in MAX-PC Fear of Recurrence Subscale Score (LOCF)|"The MAX-PC fear of recurrence subscale consists of 4 questions related to fear of recurrence; Because cancer is unpredictable, I feel I cannot plan for the future., My fear of having my cancer getting worse gets in the way of my enjoying life., I am afraid of my cancer getting worse., I am more nervous since I was diagnosed with prostate cancer. A higher MAX-PC score indicates greater anxiety. Scores range from 0 to 3 for each question. The total score is the sum of the 4 question scores: 0 to 12."|Baseline and Months 3, 6, 12, 18, and 36|ITT Population. Only participants with both available baseline and post-baseline values were analyzed at the indicated time points. As the study progressed, participants dropped out of the study or did not complete the questionnaire.||points on a scale||Standard Deviation|Mean
727378|NCT00363311|Secondary|Total MAX-PC Fear of Recurrence Subscale Score|"The MAX-PC fear of recurrence subscale consists of 4 questions related to fear of recurrence; Because cancer is unpredictable, I feel I cannot plan for the future., My fear of having my cancer getting worse gets in the way of my enjoying life., I am afraid of my cancer getting worse., I am more nervous since I was diagnosed with prostate cancer. A higher MAX-PC score indicates greater anxiety. Scores range from 0 to 3 for each question. The total score is the sum of the 4 question scores: 0 to 12."|Baseline and Months 3, 6, 12, 18, and 36|ITT Population. As the study progressed, participants dropped out of the study or did not complete the questionnaire.||points on a scale||Standard Deviation|Mean
727379|NCT00363311|Secondary|Change From Baseline in MAX-PC Anxiety Subscale Score Related to PSA Testing (LOCF)|"The MAX-PC anxiety subscale consists of 3 questions related to PSA testing; I have been so anxious about my PSA test that I have thought about delaying it., I have been so worried about my PSA test result that I have thought about asking my doctor to repeat the test., I have been so concerned about my PSA test result that I have thought about having the test repeated at another laboratory to make sure the test results were accurate. A higher MAX-PC score indicates greater anxiety.Scores range from 0 to 3 for each question. The total score is the sum of the 3 question scores; 0 to 9."|Baseline and Months 3, 6, 12, 18, and 36|ITT Population. As the study progressed, participants dropped out of the study or did not complete the questionnaire.||points on a scale||Standard Deviation|Mean
727380|NCT00363311|Secondary|Total MAX-PC Anxiety Subscale Score Related to PSA Testing|"The MAX-PC anxiety subscale consists of 3 questions related to PSA testing; I have been so anxious about my PSA test that I have thought about delaying it., I have been so worried about my PSA test result that I have thought about asking my doctor to repeat the test., I have been so concerned about my PSA test result that I have thought about having the test repeated at another laboratory to make sure the test results were accurate. A higher MAX-PC score indicates greater anxiety.Scores range from 0 to 3 for each question. The total score is the sum of the 3 question scores; 0 to 9."|Baseline and Months 3, 6, 12, 18, and 36|ITT Population. As the study progressed, participants dropped out of the study or did not complete the questionnaire.||points on a scale||Standard Deviation|Mean
727381|NCT00363311|Secondary|Change From Baseline in Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC) LOCF|The MAX-PC is a self-reported measure evaluating three aspects of PC-related anxiety: general anxiety related to PC/treatment, fear of recurrence, and anxiety related to PSA testing. The MAX-PC consists of 18 questions, each score ranging from 0 (least anxiety) to 3 (maximum anxiety). Total score is the sum of each question score, thus ranging from 0 to 54. A higher MAX-PC score indicates greater anxiety. At Months 18 and 36, participants were given an additional copy of the questionnaire and were asked to complete at home once they were notified of their PSA result and to send back to clinic.|Baseline and Months 3, 6, 12, 18, and 36|ITT Population. Only participants with both available baseline and post-baseline values were analyzed at the indicated time points. As the study progressed, participants dropped out of the study or did not complete the questionnaire.||points on a scale||Standard Deviation|Mean
727382|NCT00363311|Secondary|Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC)|The MAX-PC is a self-reported measure evaluating three aspects of PC-related anxiety: general anxiety related to PC/treatment, fear of recurrence, and anxiety related to PSA testing. The MAX-PC consists of 18 questions, each score ranging from 0 (least anxiety) to 3 (maximum anxiety). Total score is the sum of each question score, thus ranging from 0 to 54. A higher MAX-PC score indicates greater anxiety. At Months 18 and 36, participants were given an additional copy of the questionnaire and were asked to complete at home once they were notified of their PSA result and to send back to clinic.|Baseline and Month 3, 6, 12, 18, and 36|ITT Population. As the study progressed, participants dropped out of the study or did not complete the questionnaire.||points on a scale||Standard Deviation|Mean
727383|NCT00363311|Secondary|Percent Change From Baseline in Prostate Volume at Years 1.5 and 3|"Prostate volume was determined at baseline, Year 1.5, and Year 3. The anteroposterior, cephalocaudal, and transverse diameters of the prostate were obtained by transrectal ultrasound (TRUS) to calculate the prostate volume using the following formula:
π/ 6 (anteroposterior width * cephalocaudal width * transverse width). Prostate volume calculated by pre-programmed equipment is unacceptable for the on-study prostate volume measurements."|Baseline and Years 1.5 and 3|ITT Population. As the study progressed, participants dropped out of the study.||percent change||Standard Deviation|Mean
727384|NCT00363311|Secondary|Change From Baseline in Prostate Volume at Years 1.5 and 3|"Prostate volume was determined at baseline, Year 1.5, and Year 3. The anteroposterior, cephalocaudal, and transverse diameters of the prostate were obtained by transrectal ultrasound (TRUS) to calculate the prostate volume using the following formula:
π/ 6 (anteroposterior width * cephalocaudal width * transverse width). Prostate volume calculated by pre-programmed equipment was unacceptable for the on-study prostate volume measurements."|Baseline and Years 1.5 and 3|ITT Population. As the study progressed, participants dropped out of the study.||cc||Standard Deviation|Mean
727385|NCT00363311|Secondary|Prostate Volume (PV) LOCF|"Prostate volume was determined at baseline, at Year 1.5, and at Year 3. The anteroposterior, cephalocaudal, and transverse diameters of the prostate were obtained by transrectal ultrasound (TRUS) to calculate the prostate volume using the following formula:
π/ 6 (anteroposterior width * cephalocaudal width * transverse width). Prostate volume calculated by pre-programmed equipment is unacceptable for the on-study prostate volume measurements."|Baseline and Years 1.5 and 3|ITT Population. As the study progressed, participants dropped out of the study. Last observation carried forward (LOCF) was used.||cubic centimeters (cc)||Standard Deviation|Mean
727386|NCT00363311|Secondary|Number of Post-baseline Biopsies With the Indicated Change From Baseline in Clinical Stage|"All on-study or for-cause biopsies were reviewed and analyzed by a central pathologist. The National Comprehensive Network (NCCN), 2005 clinical practices guidelines in Oncology-prostate cancer were used for clinical tumor staging. T0: no evidence of primary tumor; T1: clinically inapparent tumor, neither palpable nor visible by imaging; T2: tumor confined within the prostate; T3: tumor extends through the prostate capsule; T4: tumor is fixed or invades adjacent structures other than seminal vesicles. A clinical stage of T0 in post-baseline biopsies has been interpreted as No Worsening."|Months 0-18|ITT Population. As the study progressed, participants dropped out of the study.||biopsies|||Number
727387|NCT00363311|Secondary|Number of Biopsies With the Indicated Clinical Tumor Stage at Baseline|All on-study or for-cause biopsies were reviewed and analyzed by a central pathologist. The 2005 International Society of Urological Pathologists recommendations for clinical tumor staging were used. T1c = tumor identified by needle biopsy (e.g., because of elevated prostate-specific antigen [PSA]); T2 = tumor confined within the prostate; T2a = tumor involves one-half of one lobe, but not both lobes of the prostate.|Baseline|ITT Population||biopsies|||Number
727388|NCT00363311|Secondary|Number of Participants With the Indicated Total Gleason Score|All on-study or for-cause biopsies were reviewed and analyzed by a central pathologist. The 2005 International Society of Urological Pathologists recommendations for Gleason scoring were used to grade the tumor. A primary grade is assigned to the most common tumor pattern (how the cancer cells look under a microscope), and a secondary grade to the next most common tumor pattern. The two grades are added together to get a GS. The Gleason grade ranges from 1 to 5, with 5 having the worst prognosis. The Gleason score ranges from 2 to 10, with 10 having the worst prognosis.|Years 0-3 (Final Biopsy)|ITT Population. As the study progressed, participants dropped out of the study.||participants|||Number
727389|NCT00363311|Secondary|Number of Participants With the Indicated Change From Baseline in Gleason Score on Repeat Biopsy at Years 0-3|The 2005 International Society of Urological Pathologists recommendations for Gleason scoring were used to grade tumors. A primary grade is assigned to the most common tumor pattern (how the cancer cells look under a microscope), and a second grade to the next most common pattern. The two grades are added together to get a GS. Gleason grade range= 1-5; 5=worst prognosis. GS range=2-10; 10=worst prognosis. Improvement is defined as a decrease in GS from a baseline score of 6 (GS<=6; includes no cancer); worsening is defined as an increase in GS from a baseline score of 6 (GS >6).|Years 0-3 (Final Biopsy)|ITT Population. As the study progressed, participants dropped out of the study.||participants|||Number
727390|NCT00363311|Secondary|Number of Participants With the Indicated Change From Baseline in Gleason Score (GS) on Repeat Biopsy at Year 1.5|The 2005 International Society of Urological Pathologists recommendations for Gleason scoring were used to grade tumors. A primary grade is assigned to the most common tumor pattern (how the cancer cells look under a microscope), and a second grade to the next most common pattern. The two grades are added together to get a GS. Gleason grade range= 1-5; 5=worst prognosis. GS range=2-10; 10=worst prognosis. Improvement is defined as a decrease in GS from a baseline score of 6 (GS<=6; includes no cancer); worsening is defined as an increase in GS from a baseline score of 6 (GS >6).|Year 1.5|ITT Population. As the study progressed, participants dropped out of the study.||participants|||Number
727391|NCT00363311|Secondary|Change From Baseline in the Cumulative Length of Cancer Tumor Core at Years 1.5, 3, and 0-3|All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist.|Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)|ITT Population. As the study progressed, participants dropped out of the study.||millimeters||Standard Deviation|Mean
727392|NCT00363311|Secondary|Cumulative Length of Cancer Tumor Core|All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist. Tumor length is calculated as the number of cores (12) * total tumor length/number of evaluated cores.|Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)|ITT Population. As the study progressed, participants dropped out of the study.||millimeters||Standard Deviation|Mean
727393|NCT00363311|Secondary|Change From Baseline in the Percentage of Cancer-positive Cores in a 12-core Biopsy at Years 1.5, 3, and 0-3|All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist. (100 * number of positive cores/number of evaluated cores).|Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)|ITT Population. As the study progressed, participants dropped out of the study.||percentage of cores||Standard Deviation|Mean
727394|NCT00363311|Secondary|Mean Percentage of Cancer-positive Cores in a 12-core Biopsy|All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsies (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist. The sum of cancer positive cores and the sum of evaluated cores were used to compute the percentage (100* number of positive cores/number of evaluated cores).|Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)|ITT Population. As the study progressed, participants dropped out of the study.||percentage of cores||Standard Deviation|Mean
727443|NCT00375505|Secondary|Change in Anti-Mueller Hormone (AMH) From Baseline to Month 24|Change in anti-Mueller hormone (AMH) from baseline to month 24|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.||ng/ml||Standard Deviation|Mean
727395|NCT00363311|Secondary|Change From Baseline in the Number of Cancer-positive Cores in a 12-core Biopsy at Years 1.5, 3, and 0-3|All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist. Change from baseline was calculated as the number of cancer-positive cores at post-baseline biopsy minus the number of cancer-positive cores at baseline.|Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)|ITT Population. As the study progressed, participants dropped out of the study.||cores||Standard Deviation|Mean
727396|NCT00363311|Secondary|Number of Cancer-positive Cores in a 12-core Biopsy|All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist. . The final biopsy is defined as the latest post-baseline biopsy for which the results are available from the central pathology laboratory.|Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)|ITT Population. As the study progressed, participants dropped out of the study.||cores||Standard Deviation|Mean
727397|NCT00363311|Secondary|Participants With at Least One Post-baseline Biopsy With the Indicated Prostate Cancer (PCa) Diagnosis for Their Final Biopsy|All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. If a for-cause biopsy occurred within 6 months prior to the protocol-mandated biopsy, the biopsy was counted as the protocol-mandated biopsy. The final biopsy is defined as the latest post-baseline biopsy for which the results are available from the central pathology laboratory.|Years 0-3|ITT Population. As the study progressed, participants dropped out of the study.||participants|||Number
727398|NCT00363311|Secondary|Participants With at Least One Post-baseline Biopsy With the Indicated Prostate Cancer (PCa) Diagnosis|All participants were required by protocol to undergo a transrectal ultrasound (TRUS)-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. If a for-cause biopsy occurred within 6 months prior to the protocol-mandated biopsy, the biopsy was counted as the protocol-mandated biopsy. All biopsies were reviewed and analyzed by a central pathologist.|Baseline to Month 18|ITT Population. As the study progressed, participants dropped out of the study.||participants|||Number
727399|NCT00363311|Secondary|Number of Participants With Pathologic Progression|Pathological progression is defined as one of the following: >=4 cores involved; >=50% of any 1 core involved; or a Gleason pattern of >=4 as a result of any on-study/for-cause biopsy. The 2005 International Society of Urological Pathologists recommendations for Gleason scoring (GS) were used to grade tumors. A primary grade is assigned to the most common tumor pattern, and a second grade to the next most common tumor pattern. The two grades are added together to get a GS. The Gleason grade=1-5, with 5 having the worst prognosis. The Gleason score=2-10, with 10 having the worst prognosis.|Year 1.5 and Overall (Years 0-3)|ITT Population. As the study progressed, participants dropped out of the study prior to meeting the primary endpoint for reasons other than disease progression or refused to have a biopsy performed.||participants|||Number
727400|NCT00363311|Secondary|Number of Participants With Therapeutic Progression|Primary therapy, also referred to as therapeutic progression, for prostate cancer can be one of the following: prostatectomy, radiation, or hormonal therapy.|Year 1.5 and Overall (Years 0-3)|ITT Population||participants|||Number
727401|NCT00363311|Primary|Number of Participants With Prostate Cancer (PCa) Progression [Restricted Crude Rate Analysis: Number of Participants With PCa Divided by Number of Participants in the Intent-to-Treat (ITT) Population Who Had >=1 Post-baseline Biopsy or Had a Progression|PC progression (prog.) was defined as the earliest occurrence of primary therapy, also referred to as therapeutic prog., for PC (prostatectomy/radiation/hormonal therapy); or pathological prog., defined as 1 of the following: >=4 cores involved; >=50% of any 1 core involved; or a Gleason pattern of >=4 as a result of any on-study/for-cause biopsy. Primary Gleason grade is assigned to the most common tumor pattern; a second grade to the next most common tumor pattern. The two grades are added together to get a score. Gleason grade= 1-5; Gleason score=2-10; 5 and 10 indicate worst prognosis.|Year 1.5 and Overall (Years 0-3)|ITT Population: all participants randomized to study treatment. Some participants dropped out of the study prior to meeting the primary endpoint for reasons other than disease progression or refused to have a biopsy performed.||participants|||Number
727402|NCT00374543|Primary|Hamilton Anxiety Rating Scale (HAM-A)|"The 14-item Hamilton Anxiety Rating Scale (HAM-A) (Hamilton, 1959) was developed to assess anxiety in a clinical population. It is considered a measure of general anxiety across anxiety disorders, in addition to being a gold standard measure for GAD.
Due to study termination, there are not results for primary and secondary outcome measures."|8 weeks|Zero participants were analyzed because recruitment was very low. Due to this, we felt any analysis done would not be usable for accurate analyses.|||||
727403|NCT00374543|Secondary|Clinical Global Impression of Improvement (CGI-I)|"A secondary categorical outcome of response will be defined as a Clinical Global Impression Improvement Score (CGI-I) of 1 or 2. The CGI-I is a 7 point clinician-rated scale that assesses symptom improvement or worsening relative to a previous assessment. Lower ratings reflect greater improvement.
Due to study termination, there are not results for primary and secondary outcome measures."|8 weeks||||||
727426|NCT00375427|Secondary|Median Time to First Skeletal Related Event(s) (SRE)|Median Time to first skeletal related event (SRE) is defined as the time from randomization to the date of first occurrence of any SRE which includes at least one of the following: radiation therapy to bone, pathologic bone fracture, spinal cord compression, surgery to bone, and hypercalcemia of malignancy (HCM). Due to the few numbers of SRE, Kaplan-Meier estimate never reaches a failure probability >=25%; so median time, 25th and 75th percentiles are not determined.For this reason only the estimated percentage of patient SRE free are reported at each time point.|12 month|||Day|||Number
727421|NCT00375427|Secondary|Assessment of the Eastern Cooperative Oncology Group (ECOG) Performance Score|ECOG Performance Score has 4 grades. 0 = Fully active, able to carry out all pre-disease activities; 1 = Restricted in strenuous activity but ambulatory and able to carry out work of light or sedentary nature; 2 = Ambulatory and capable of all self-care but unable to carry out work activities. Active about 50% of waking hours; 3 = Capable of limited self-care, confined to bed/chair more than 50% of waking hours; 4 = Completely disabled; cannot carry on self-care. Totally confined to bed/chair. Outcome is given as median score for participants at Baseline and 3, 6 , 9 and 12 months of treatment|At Baseline, Month 3, Month 6, Month 9 and Month 12|Intent-to-treat (ITT) population will include all randomized patients.||score on a scale||Full Range|Median
727422|NCT00375427|Secondary|Use Of Analgesic Medications According to the Analgesic Score Scale|"The analgesic score used for this study is modified from the Radiation Therapy Oncology Group (RTOG) analgesic score scale. The scale represents type of medication administered from 0 to 4 where:
0 = None
= Minor analgesics (aspirin, NSAID, acetaminophen, propoxyphene, etc.)
= Tranquilisers, antidepressants, muscle relaxants, and steroids
= Mild narcotics (oxycodone, meperidine, codeine, etc.)
= Strong narcotics (morphine, hydromorphone, etc.) The outcome is given a the median score for the participants at Baseline and 3, 6, 9 and 12 months of treatment"|At Baseline, Month 3, Month 6, Month 9 and Month 12|Intent-to-treat (ITT) population will include all randomized patients.||score on a scale||Full Range|Median
727423|NCT00375427|Secondary|Evaluation of Pain According to Verbal Rating Scale (VRS) Based on Median Score Value|Pain intensity at rest and on movement is rated by the patient by means of a validated 6-point Verbal Rating Scale (VRS) and refers to the pain which occurred during the last week before the assessment. Median score value is the median of all the observed scores (none=0, very mild=1, mild=2, moderate=3, severe=5 and very severe=6) at each time point.|At Baseline, Month 3, Month 6, Month 9 and Month 12|Intent-to-treat (ITT) population will include all randomized patients.||score on a scale||Full Range|Median
727424|NCT00375427|Secondary|Composite Bone Pain Score According to the Brief Pain Inventory (BPI) Questionnaire|Bone pain was assessed by means of a pain score obtained using the Brief Pain Inventory (BPI) questionnaire. The BPI can produce three pain scores: worst pain, a composite pain score, and a pain interference score. The composite pain score, which is the average of questions 3, 4, 5 and 6 of the questionnaire was used in this study. Pain was rated on a scale of 0 (no pain) to 10 (pain as bad as you can imagine). The outcome is given as the median score for participants at baseline, and 3, 6, 9 and 12 months of treatment|At Baseline, Month 3, Month 6, Month 9 and Month 12|Intent-to-treat (ITT) population will include all randomized patients. All ITT patients with BPI questionnaire filled up at baseline were included.||score on a scale||Standard Deviation|Mean
727425|NCT00375427|Secondary|Percentage of Participants Skeletal Related Event (SRE) Free|"Percentage of participants SRE free is defined as the Kaplan-Meier estimate of participants free of any Skeletal Related Events(SRE) at each time point.
Skeletal Related Events (SREs) are:
pathologic bone fracture; non-vertebral and vertebral
spinal cord compression identified by X-rays
surgery to bone both curative and prophylactic
radiation therapy to bone (palliative, therapeutic or prophylactic)
hypercalcemia of malignancy, defined as a corrected serum calcium > 12 mg/dl (3.00 mmol/l) or a lower level which is symptomatic and requires treatment other than rehydration."|12 months|Intent-to-treat (ITT) population will include all randomized patients.||Percentage of participants||95% Confidence Interval|Number
728445|NCT00380250|Secondary|Month 2 Abdominal Bloating Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|Change from baseline for month 2|ITT with LOCF||Scale score||Standard Deviation|Mean
727427|NCT00375427|Secondary|Annual Incidence of Any Skeletal Related Events (SREs)|"Skeletal Related Events (SREs) are defined as a:
pathologic bone fracture such as non-vertebral and vertebral
spinal cord compression identified by X-rays evidence
surgery to bone both curative and prophylactic
radiation therapy to bone including palliative, therapeutic or prophylactic
hypercalcemia of malignancy, defined as a corrected serum calcium > 12 mg/dl (3.00 mmol/l) or a lower level of hypercalcemia which is symptomatic and which requires active treatment other than rehydration. Annual incidence for each SRE was computed in the same way as annual overall SMR."|12 months|Intent-to-treat (ITT) population will include all randomized patients.||Number of SRE per Year||Standard Deviation|Mean
727428|NCT00375427|Secondary|Percentage of Participants Experiencing Skeletal Related Event(s) (SREs)|"Skeletal Related Events (SREs) are defined as a:
pathologic bone fracture such as non-vertebral and vertebral compression fractures
spinal cord compression identified by positive diagnosis documented by X-ray evidence
surgery to bone both curative and prophylactic
radiation therapy to bone including palliative, therapeutic or prophylactic
hypercalcemia of malignancy, defined as a corrected serum calcium > 12 mg/dl (3.00 mmol/l) or a lower level of hypercalcemia which is symptomatic and which requires active treatment other than rehydration."|12 month|Intent-to-treat (ITT) population will include all randomized patients.||Percentage of Participants|||Number
727429|NCT00375427|Primary|Annual Overall Skeletal Morbidity Rate (SMR)|"The SMR was computed by summing all Skeletal Related Event(s) (SREs)which occurred during the observation period and dividing it by the ratio “days of observation period / 365.25”, for each participant. SRE was defined as: pathologic bone fracture, spinal cord compression, surgery to bone both curative and prophylactic, radiation therapy to bone, or hypercalcemia of malignancy.
SMR (years) = 365.25 x SMR(days) where SMR (days) = total number of SREs / total SRE risk period (days). Risk period for SMR was computed as the days from randomization date to the date of last visit."|12 months|Intent-to-treat (ITT) population will include all randomized patients.||Number of Skeletal Events per Year||Standard Deviation|Mean
727430|NCT00375492|Secondary|Rate of Hypoglycemic Events|Overall rate of hypoglycemia, adjusted for 1 year (ie., events of hypoglycemia per participant per year).|24 weeks|Intent to Treat population||events per patient per year||Standard Error|Least Squares Mean
727431|NCT00375492|Secondary|Number of Participants With Hypoglycemic Events During the Study|Number of participants experiencing one or more events of hypoglycemia at any point in the study|Baseline to 24 weeks|Intent to Treat population||participants|||Number
727432|NCT00375492|Secondary|Ratio of Triglycerides at Week 24 to Triglycerides at Baseline|Ratio of triglyceride levels at Week 24 to triglyceride levels at baseline, Week 0 (ie., triglycerides at Week 24 divided by triglycerides at baseline, Week 0). Triglycerides measured in mmol/L.|baseline, Week 24|Intent to Treat population||Ratio||Standard Error|Geometric Mean
727433|NCT00375492|Secondary|Change From Baseline in Total Cholesterol at Week 24|Change in total cholesterol from baseline after 24 weeks of treatment (i.e., total cholesterol at week 24 minus total cholesterol at week 0). Total cholesterol measured in mmol/L.|baseline, week 24|Intent to Treat population||mmol/L||Standard Error|Least Squares Mean
727434|NCT00375492|Secondary|Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol at Week 24|Change in LDL cholesterol from baseline (Week 0) after 24 weeks of treatment (ie., LDL cholesterol at week 24 minus LDL cholesterol at week 0). LDL cholesterol measured in mmol/L|baseline, Week 24|Intent to Treat population||mmol/L||Standard Error|Least Squares Mean
727435|NCT00375492|Secondary|Change From Baseline in High Density Lipoprotein (HDL) Cholesterol at Week 24|Change in HDL cholesterol from baseline after 24 weeks of treatment (i.e., HDL cholesterol at week 24 minus HDL cholesterol at week 0). HDL measured as mmol/L.|baseline, Week 24|Intent to Treat population||mmol/L||Standard Error|Least Squares Mean
727436|NCT00375492|Secondary|Ratio of Homeostatic Model Assessment-Insulin Sensitivity (HOMA-S) at Week 24 to HOMA-S at Baseline|Ratio of HOMA-S at Week 24 to HOMA-S at baseline, week 0. HOMA-S is a computer solved model used to predict the homeostatic concentrations which arise from varying degrees of insulin sensitivity. HOMA-S allows a quantitative assessment of the contributions of insulin sensitivity to the fasting hyperglycemia. HOMA-S is measured as a percent of the normal population (normal insulin sensitivity = 100%, which is used as a reference in the calculation). The higher the percent the better for the participant.|baseline, Week 24|Intent to Treat population||Ratio||Standard Error|Geometric Mean
727437|NCT00375492|Secondary|Ratio of Homeostatic Model Assessment-Beta Cell (HOMA-B) at Week 24 to HOMA-B at Baseline|Ratio of HOMA-B at Week 24 to HOMA-B at baseline (Week 0). HOMA-B is a computer solved model used to predict the homeostatic concentrations which arise from varying degrees beta-cell deficiency. HOMA-B allows a quantitative assessment of the contributions of deficient beta cell function to the fasting hyperglycemia. HOMA-B is measured as a percent of the normal population (normal beta cell function = 100%, which is used as a reference in the calculation). The higher the percent the better for the participant.|baseline, Week 24|Intent to Treat population||Ratio||Standard Error|Geometric Mean
727438|NCT00375492|Secondary|Change From Baseline in Waist Circumference at Week 24|Change in waist circumference from baseline after 24 weeks of treatment (i.e., waist circumference at week 24 minus waist circumference at week 0). Waist measured in centimeters (cm).|baseline, Week 24|Intent to Treat population||cm||Standard Error|Least Squares Mean
727439|NCT00375492|Secondary|Change From Baseline in 6-point Self Monitored Blood Glucose (SMBG) Profile at Week 24|Change in SMBG at each of 6 time points throughout a day (blood glucose measurements before and 2 hours after the start of the morning, mid-day, and evening meals); week 24 compared to week 0 (i.e., SMBG at week 24 minus SMBG at week 0). Fasting Glucose measured in millimoles per liter (mmol/L).|baseline, Week 24|Intent to Treat population||mmol/L||Standard Error|Least Squares Mean
727440|NCT00375492|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|Change in HbA1c from baseline (Week 0) after 24 weeks of treatment (i.e., HbA1c at week 24 minus HbA1c at week 0). HbA1c is measured as percent (%) of hemoglobin.|baseline, Week 24|Intent to Treat population||percent hemoglobin||Standard Error|Least Squares Mean
727441|NCT00375492|Primary|Change From Baseline in Body Weight|Change in body weight from baseline (Week 0) after 24 weeks of treatment (i.e., weight at week 24 minus weight at week 0). Body weight measured in kilograms (k).|Baseline, Week 24|Intent to Treat population||kg||Standard Error|Least Squares Mean
727444|NCT00375505|Secondary|Change in Vitamine D From Baseline to Month 24|Change in Vitamine D from baseline to month 24|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.||ng/ml||Standard Deviation|Mean
727445|NCT00375505|Secondary|Change in Parathyroid Hormone (PTH) From Baseline to Month 24|Change in Parathyroid Hormone (PTH) from baseline to month 24|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.||pg/ml||Standard Deviation|Mean
727446|NCT00375505|Secondary|Change in Sex Hormone Binding Globulin (SHGB) From Baseline to Month 24|Change in Sex Hormone binding globulin (SHGB) from baseline to month 24|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.||nmol/l||Standard Deviation|Mean
727447|NCT00375505|Secondary|Change in Testosterone From Baseline to Month 24|Change in Testosterone from baseline to month 24|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.||ng/ml||Standard Deviation|Mean
727448|NCT00375505|Secondary|Change in Follicle- Stimulating Hormone (FSH) From Baseline to Month 24|Change in Follicle- Stimulating Hormone (FSH) from baseline to month 24|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.||mIU/ml||Standard Deviation|Mean
727449|NCT00375505|Secondary|Change in Estradiol (E2) From Baseline to Month 24|Change in Estradiol from baseline to month 24|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.||ng/L||Standard Deviation|Mean
727450|NCT00375505|Secondary|Change in Aminoterminal Propeptide on Type I Procollagen (P1NP) From Baseline to Month 24|Change in Aminoterminal propeptide on type I procollagen (P1NP) from baseline to month 24. P1NP is a marker for bone formation. It is a specific indicator of type 1 collagen deposition. P1NP is increased in states of high bone turnover|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.||ng/ml||Standard Deviation|Mean
727451|NCT00375505|Secondary|Change in Serum CTX-carboxy-terminal Collagen Crosslinks From Baseline to Month 24|CTX is a telopeptide that can be used as a biomarker in the serum to measure the rate of bone turnover. The test used to detect the CTX marker is specific to bone resorption.|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.||ng/mL||Standard Deviation|Mean
727452|NCT00375505|Secondary|Change in Bone Mineral Density Phalanges II, III, IV, and V From Baseline to Month 24 or Last Visit as Measured by Amplitude-dependent Speed of Sound (ADSOS)|Bone mineral density (BMD) for Phalanges II, III, IV, and V is measured by ADSOS; ADSOS is a Quantitative ultrasonography scanning and measures bone mass and strength and assesses bone microarchitecture by detecting the transmission of high-frequency sound waves through bone.|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.||m/s||Standard Deviation|Mean
727453|NCT00375505|Secondary|Change in Bone Mineral Density Os Calcis (Right and Left Side) From Baseline to Month 24 as Measured by Broadband Ultrasound Attenuation (BUA)|Bone mineral density (BMD) for Os calcis (right and left side) is measured by BUA; BUA is a Quantitative ultrasonography scanning and measures bone mass and strength and assesses bone microarchitecture by detecting the transmission of high-frequency sound waves through bone.|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.||dB/MHz||Standard Deviation|Mean
727454|NCT00375505|Secondary|Change in Bone Mineral Density Os Calcis (Right and Left Side) From Baseline to Month 24 as Measured by Speed of Sound (SOS)|Bone mineral density (BMD) for Os calcis (right and left side) is measured by SOS; SOS is a Quantitative ultrasonography scanning and measures bone mass and strength and assesses bone microarchitecture by detecting the transmission of high-frequency sound waves through bone.|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.||m/s||Standard Deviation|Mean
727455|NCT00375505|Secondary|Percentage Change in Bone Mineral Density for Total Femoral Neck (Right and Left Side) From Baseline to Month 24|Bone mineral density (BMD) for total femoral neck (right and left side) is measured by using Lunar or Hologic dual-energy X-ray absorptiometry (DXA) Instruments. Measurements were done on femoral neck (right and left side)|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.||percentage change||Standard Deviation|Mean
727456|NCT00375505|Secondary|Percentage Change in Bone Mineral Density for Femoral Neck (Right and Left Side) From Baseline to Month 24|Bone mineral density (BMD) for femoral neck (right and left side) is measured by using Lunar or Hologic dual-energy X-ray absorptiometry (DXA) Instruments. Measurements were done on femoral neck (right and left side)|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.||Percentage Change||Standard Deviation|Mean
727457|NCT00375505|Primary|Percent Change in Bone Mineral Density for L2-L4 From Baseline to Month 24 or Last Visit|Bone mineral density (BMD) at lumbar spine (L2-L4) measured by using Lunar or Hologic dual-energy X-ray absorptiometry (DXA) Instruments. Measurements were done in the lumbar vertebrae (L2-L4)|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.||percentage change||Standard Deviation|Mean
727458|NCT00375505|Primary|Change in Bone Mineral Density (BMD) at Lumbar Spine (L2-L4) From Baseline to Month 24 or Last Visit Measure by Z-score|Bone mineral density (BMD) at lumbar spine (L2-L4) measured by Z-score. If Z-score is -2 or lower, it may suggest that something other than aging is causing abnormal bone loss.|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.||Z-score||Standard Deviation|Mean
727482|NCT00375934|Secondary|Number of Patients Who Required Rescue Medication on Day 3|Day 3 data reflect the use of rescue medication only up to the time of discharge.|Day 3|||participants|||Number
727483|NCT00375934|Secondary|Number of Patients Who Required Rescue Medication on Day 2||Day 2|||participants|||Number
727459|NCT00375505|Primary|Change in Bone Mineral Density (BMD) at Lumbar Spine (L2-L4) From Baseline to Month 24 or Last Visit Measure by T-score|Bone mineral density (BMD) at lumbar spine (L2-L4) by T-score. Your T-score is the number of units that your bone density is above or below the average. -1 and above-bone density is considered normal; Between -1 and -2.5-is a sign of osteopenia, a condition in which bone density is below normal and may lead to osteoporosis. -2.5 and below-indicates that it is likely osteoporosis.|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.||T-score||Standard Deviation|Mean
727460|NCT00375505|Primary|Change in Bone Mineral Density (BMD) Measured by Dual (Energy) X-ray Absorptiometry (DXA) at Lumbar Spine (L2-L4) From Baseline to Month 24|Bone mineral density (BMD) by DXA at lumbar spine (L2-L4); DXA assessments of the BMD at dual hips. (BMD). Two X-ray beams with different energy levels are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone.|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.||Z-score||Standard Deviation|Mean
727461|NCT00375518|Primary|Determine the Postoperative Complications Found in Each Group|To determine whether one week of preventive therapy with atorvastatin prior to surgery and one week after surgery reduced the composite rate of cardiovascular morbidity when compared to placebo.|one week (minimum of 5 days) before surgery and continued for one week (minimum of 5 days) after surgery|||participants|||Number
727462|NCT00375674|Secondary|Number of Participants With Tolerability Symptoms|"Participants were followed for AEs from the first day of study treatment until at least 28 days after the last on-study treatment administration, or until all serious or study medication-related toxicities had resolved or were determined to be “chronic” or “stable,” whichever was later.
The treatment was administered to the participants from cycle1/day 1 up to 9 cycles or until relapse, secondary malignancy, death or withdraw for other reasons such as toxicity or withdraw of consent. This table provides the summary of discontinuations de to adverse events. Participants were counted only once in each row."|Cycle 1(Day 1 & Day 28); subsequent cycles (Day 1); end of treatment/withdrawal and 28 days post treatment, or until all serious or study medication-related toxicities had resolved or were determined to be “chronic” or “stable,” whichever was later|ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.||Number of participants|||Number
727463|NCT00375674|Secondary|PROs- EuroQol European Quality of Life Questionnaire Variable Analogue Scale (EQ‑VAS) Observed Means|Patient‑reported outcomes (PROs) assessed health-related quality of life (QoL) by the EuroQoL Group health status questionnaire (EQ-5D), which was a brief self-administered, validated instrument with 2 parts. The first part assessed the current health state. In this outcome measure, the second part was applied to assess the general health status by using visual analog scale (EQ-5D VAS) which measured participant's self-rated health status on a scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).|Cycle 1(Day 1); subsequent cycles (Day 1) and end of treatment/withdrawal (ie, up to 1 year)|ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.||Units on a scale||Standard Error|Mean
727464|NCT00375674|Secondary|PROs- EuroQoL EQ‑5D Observed Means – Intent to Treat Population|Patient‑reported outcomes (PROs) assessed health-related quality of life (QoL) by the EuroQoL Group health status questionnaire (EQ-5D), which was a brief self-administered, validated instrument with 2 parts. In this outcome measure, the first part with 5 descriptors of current health state (mobility, self-care, usual activities, pain/discomfort, & anxiety/depression) was used; a participant was asked to rate each state on a 3-level scale (1=no problem, 2=some problem, & 3=extreme problem); higher levels indicated greater severity/impairment. The published weights allowed the creation of a single summary score called the EQ-5D index, which ranged from −0.594 to 1; low scores represented a higher level of dysfunction & 1 as perfect health.|Cycle 1(Day 1); subsequent cycles (Day 1) and end of treatment/withdrawal (ie, up to 1 year)|ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.||Units on a scale||Standard Error|Mean
727465|NCT00375674|Secondary|PROs- EORTC QLQ‑C30: Symptom Scale Scores Between Treatment Comparison|Patient‑reported outcomes (PROs) assessed health-related quality of life (QoL) by using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), which was a 3 multi-item symptom scales (fatigue, nausea/vomiting, & pain), and 6 single item symptom scales for other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, & the financial impact of cancer). The questionnaire includes 28 items with 4-point Likert type responses from “not at all” to “very much” to assess symptoms. All responses were converted to a 0 to 100 scale using a standard scoring algorithm, higher scores represented more severe symptoms.|Cycle 1(Day 1); subsequent cycles (Day 1) and end of treatment/withdrawal (ie, up to 1 year)|ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.||Scores on scale||95% Confidence Interval|Mean
727466|NCT00375674|Secondary|PROs- EORTC QLQ C30: Functional Scale Scores Between Treatment Comparison|Patient‑reported outcomes (PROs) assessed health-related quality of life (QoL) by using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), which was a 30-item questionnaire with global QoL scale & 5 multi-item functional scales (physical, role, emotional, cognitive, & social functioning). The questionnaire includes 28 items with 4-point Likert type responses from “not at all” to “very much” to assess functioning; 2 items with 7-point Likert scales for global health & overall QoL. All responses were converted to a 0 to 100 scale using a standard scoring algorithm, higher scores represented better level for functioning/QoL.|Cycle 1(Day 1); subsequent cycles (Day 1) and end of treatment/withdrawal (ie, up to 1 year)|ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.||Scores on scale||95% Confidence Interval|Mean
727467|NCT00375674|Secondary|Patient‑Reported Outcomes (PROs)- European Organization for Research and Treatment of Cancer (EORTC) QLQ C30: Observed Means in Global Health Status / Quality of Life Scale Scores|Patient‑reported outcomes (PROs) assessed health-related quality of life (QoL) by using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), which was a 30-item questionnaire with global QoL scale, 5 multi-item functional scales (physical, role, emotional, cognitive, & social functioning), 3 multi-item symptom scales (fatigue, nausea/vomiting, & pain), and 6 single item symptom scales for other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, & the financial impact of cancer). The questionnaire includes 28 items with 4-point Likert type responses from “not at all” to “very much” to assess functioning & symptoms; 2 items with 7-point Likert scales for global health & overall QoL. All responses were converted to a 0 to 100 scale using a standard scoring algorithm, higher scores represented better level for functioning/QoL & more severe for symptoms.|Cycle 1(Day 1); subsequent cycles (Day 1) and end of treatment/withdrawal (ie, up to 1 year)|ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.||Scores on scale||Standard Error|Mean
727468|NCT00375674|Secondary|Summary of Duration of Treatment‑Emergent Adverse Events of Special Interest by MedDRA Preferred Terms (All Causalities, All Cycles)|"TEAEs are all AEs (serious and non-serious) occurred, for the first time, on or after the first day of study treatment. AEs started before the first dose of study treatment but increased in severity (CTC grade) over the baseline will also be considered TEAEs.
Participants were followed for AEs from the first day of study treatment until at least 28 days after the last on-study treatment administration, or until all serious or study medication-related toxicities had resolved or were determined to be “chronic” or “stable,” whichever was later.
The treatment was administered to the participants from cycle1/day 1 up to 9 cycles or until relapse, secondary malignancy, death or withdraw for other reasons such as toxicity or withdraw of consent."|Cycle 1(Day 1 & Day 28); subsequent cycles (Day 1); end of treatment/withdrawal and 28 days post treatment, or until all serious or study medication-related toxicities had resolved or were determined to be “chronic” or “stable,” whichever was later|The AT population included all participants who received at least 1 dose of study drug with treatment assignments designated according to actual study treatment received. This population was the primary population for evaluating treatment administration/ compliance and safety.||Weeks||Standard Deviation|Mean
727469|NCT00375674|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity|"TEAEs are all AEs (serious and non-serious) occurred, for the first time, on or after the first day of study treatment. AEs started before the first dose of study treatment but increased in severity (CTC grade) over the baseline will also be considered TEAEs.
Participants were followed for AEs from the first day of study treatment until at least 28 days after the last on-study treatment administration, or until all serious or study medication-related toxicities had resolved or were determined to be “chronic” or “stable,” whichever was later. The treatment was administered to the participants from cycle1/day 1 up to 9 cycles or until relapse, secondary malignancy, death or withdraw for other reasons such as toxicity or withdraw of consent."|Cycle 1(Day 1 & Day 28); subsequent cycles (Day 1); end of treatment/withdrawal and 28 days post treatment, or until all serious or study medication-related toxicities had resolved or were determined to be “chronic” or “stable,” whichever was later|The As-Treated (AT) population included all participants who received at least 1 dose of study drug with treatment assignments designated according to actual study treatment received. This population was the primary population for evaluating treatment administration/ compliance and safety.||Number of participants|||Number
727470|NCT00375674|Secondary|Overall Survival (OS)- (Stratified by UISS High Risk Group-Intent to Treat Population)|OS was defined as the time from the date of randomization to the date of death due to any cause.|Every 12 weeks until the time for final analysis|ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.||Year||95% Confidence Interval|Median
727471|NCT00375674|Primary|DFS- Assessed by the Investigator (Stratified by UISS High Risk Group-Intent to Treat Population)|"DFS was defined as the time interval (in years) from the date of randomization to the first date of recurrence or occurrence of a secondary malignancy or death. Recurrence refers to relapse of the primary tumor in-situ or at metastatic sites.
Date of recurrence or occurrence: The date of the recurrence or occurrence of a secondary malignancy for the first time, either by BICR or investigator assessment for the respective analyses.
Patients were followed with tumor imaging for recurrence or occurrence of a secondary malignancy for the remainder of the follow-up period unless the patient had withdrawn consent.
According to the statistical analysis plan there are two cohorts: 1.Global Cohort: primary analysis of DFS was performed approximately 5 years after last subject in the Global Cohort is randomized; 2. China Cohort: primary analysis of DFS was performed approximately 3 years after the last subject in China Cohort was randomized."|Every 12 weeks during the first 3 years and every 6 months after that unless the patient had withdrawn consent. Performed 5 years after LSLV or when approximately 258 events survival status, whichever was later|ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.||Number of years||95% Confidence Interval|Median
727484|NCT00375934|Secondary|Number of Patients Who Required Rescue Medication on Day 1||Day 1|||participants|||Number
727485|NCT00375934|Secondary|Time to Onset of at Least 30% Reduction in Pain Intensity After First Dose of Study Drug||8 hours post single dose|Number of participants analyzed includes only the number of participants with at least 30% reduction in pain intensity after first dose of study drug (see previous outcome measure #7).||minutes||95% Confidence Interval|Median
727486|NCT00375934|Secondary|Number of Patients With at Least 30% Reduction in Pain Intensity After First Dose of Study Drug||8 hours post single dose|||participants|||Number
727640|NCT00377572|Secondary|Percent Prevalence: Asthma-Related Medical Care Resource Utilization - Hospitalizations|Percent participants with >=1 hospitalizations. A hospitalization is defined as an asthma-related, overnight hospitalization. . Results values are model predicted numbers,(e.g., odds ratios converted to percentages).|Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.|Intent-to-treat||percent prevalence|||Number
727472|NCT00375674|Primary|Disease-free Survival (DFS)- Assessed by Blinded Independent Central Review|"DFS was defined as the time interval (in years) from the date of randomization to the first date of recurrence or occurrence of a secondary malignancy or death. Recurrence refers to relapse of the primary tumor in-situ or at metastatic sites.
Date of recurrence or occurrence: The date of the recurrence or occurrence of a secondary malignancy for the first time, either by blinded independent central review (BICR) or investigator assessment for the respective analyses.
Participants were followed with tumor imaging for recurrence or occurrence of a secondary malignancy for the remainder of the follow-up period unless the patient had withdrawn consent.
According to the statistical analysis plan there are two cohorts: 1.Global Cohort: primary analysis of DFS was performed approximately 5 years after last subject in the Global Cohort is randomized; 2. China Cohort: primary analysis of DFS was performed approximately 3 years after the last subject in China Cohort was randomized."|Every 12 weeks during the first 3 years and every 6 months after that unless the patient had withdrawn consent. Performed 5 years after LSLV or when approximately 258 events survival status, whichever was later.|Intent to treat (ITT) population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.||Number of years||95% Confidence Interval|Median
727473|NCT00375713|Secondary|Global Improvement at Endpoint During the 14 Day Treatment Period|Global improvement is measured on an ordered nominal scale ranging from marked improvement to exacerbation (see categories in the table). The endpoint is visit 4 on day 14 or at an earlier time point at study completion.|At endpoint during the 14 day treatment period|All patients in modified ITT except 1 patient in levocetirizine group and 3 patients in cetirizine group who have missing values.||Participants|||Number
727474|NCT00375713|Secondary|Duration of Pruritus (Stated in Categories) at Endpoint During the 14 Day Treatment Period|Duration of pruritus was categorized as follows: 3 if > 6 hours/24hr, 2 if 1 to 6 hours/24hr, 1 if less than 1 hour/24hr, and 0 if No pruritus. The endpoint is visit 4 on day 14 or at an earlier time point at study completion.|At endpoint during the 14 day treatment period|All patients in modified Intent-to-treat population. Last Observation Carried Forward principle was applied to the missing data of the pruritus severity score on the previous day of the randomization.||Units on a scale||Standard Error|Mean
727475|NCT00375713|Secondary|Change From Baseline in the Mean Pruritus Severity Score at Endpoint During the 14 Day Treatment Period|The Pruritus Score Scale ranges from 0 to 3 (3 for Severe, 2 for Moderate, 1 for Mild and 0 for None). Endpoint is at visit 4 on day 14 or at an earlier timepoint at study completion.|Baseline and at endpoint during the 14 day treatment period|All patients in modified Intent-to-treat population. Last Observation Carried Forward principle was applied to the missing data of the pruritus severity score on the previous day of the randomization.||Units on a scale||Standard Error|Mean
727476|NCT00375713|Primary|Responder Status According to Pruritus Severity Score (Response = Mild or None in Pruritus Severity Score).|A participant is a responder if the pruritus severity score is assessed as mild or none, otherwise it is a non-responder. The responder status is defined at day 14, except if the investigator assessed the subject as a responder at day 7. The Pruritus Score is in general defined as: 3 for Severe, 2 for Moderate, 1 for Mild and 0 for None.|Day 7 and 14|The modified ITT population is defined as all randomized patients who received the study drug, except the patients who did not meet the entry criteria, took prohibited medication during the study period, did not have any available data for efficacy evaluation and who were enrolled with packing errors.||Participants|||Number
727487|NCT00375934|Secondary|Total Pain Relief (TOTPAR) Scores 8 Hours Post Initial Dose of Study Drug|Pain relief was rated using a 5-point categorial scale (0=none, 1=a little, 2=some, 3=a lot, and 4=complete) at time of dose (time=0) and over 15 time points afterwards (10, 15, 20, 30, 45, and 60 minutes and at 1.5, 2, 2.5, 3, 4, 5, 6, 7, and 8 hours after the initial dose on Day 1 or until time of re-medication). A score of 0 across all time points would be the lowest (worst) and a score of 60 (4 X 15 time points) would be the highest (best) possible score.|8 hourse post single dose|||units on a scale||Standard Deviation|Mean
727488|NCT00375934|Secondary|Median Time to Onset of Pain Relief in Patients With Meaningful Pain Relief on Day 1||8 hours post single dose|"Number of participants analyzed includes only the number of participants with meaningful pain relief on Day 1 (see previous outcome measure #4).
Number of patients in the placebo group is intentionally blank as the data (eg., median and upper CI) were not calculable (see post-hoc outcome measure #12 for available placebo results)."||minutes||95% Confidence Interval|Median
727489|NCT00375934|Secondary|Number of Patients With Meaningful Pain Relief on Day 1|Times to onset of Perceptible and Meaningful Relief were determined using the double-stopwatch method.|8 hours post single dose|||participants|||Number
727490|NCT00375934|Secondary|Median Time to Onset of Pain Relief in Patients With Perceptible Pain Relief on Day 1||8 hours post single dose|Number of participants analyzed includes only the number of participants with perceptible pain relief on Day 1 (see previous outcome measure #2).||minutes||95% Confidence Interval|Median
727491|NCT00375934|Secondary|Number of Patients With Perceptible Pain Relief on Day 1|Times to onset of Perceptible and Meaningful Relief were determined using the double-stopwatch method.|8 hours post single dose|||participants|||Number
727492|NCT00375934|Primary|Average Numeric Pain Rating Score (NPRS) Over 48 Hours After Bunionectomy|Pain intensity scores were measured using an 11-point numerical pain rating scale (NPRS) with 0=no pain to 10=worst possible pain|Over 48 hours after bunionectomy|||units on a scale||Standard Deviation|Mean
727493|NCT00375973|Secondary|Number of Participants Who Discontinued Use of Treatment Due to Adverse Events|Paticipants who dropped out of the study because of intolerable adverse events.|Any time after randomization up to 12 weeks.|One patient in the duloxetine group did not have post-baseline data.||participants|||Number
727494|NCT00375973|Secondary|Number of Participants Who Discontinued the Study for Any Reason|Description of discontinuation rates of participants; all participants who dropped out of the study after randomization were included. The reasons for drop outs included lack of efficacy, adverse event, lost to follow-up, personal conflict or other patient decision, withdrawal of informed consent, and non-compliance.|Any time after randomization up to 12 weeks.|||participants|||Number
727495|NCT00375973|Secondary|Patient Global Impression of Improvement (PGI-I)|Patient rated assessment of change on a 1 (very much better) to 7 (very much worse) scale.|baseline to endpoint at 12 weeks.|For the efficacy analysis, in the duloxetine group, 3 patients were not included in analysis for the following reasons: one patient's treatment group assignment was unblinded owing to a serious adverse event of suicidal ideation; 2 other patients did not have compliant postbaseline visits.||units on a scale||Standard Deviation|Mean
727496|NCT00375973|Secondary|Change From Baseline in the Clinical Global Impression of Severity (CGI-S)|Clinician rated assessment of severity on a 1 (normal)-7 (extremely ill) scale. A decrease in the score indicates improvement.|baseline to endpoint at 12 weeks|For the efficacy analysis, in the duloxetine group, 3 patients were not included in analysis for the following reasons: one patient's treatment group assignment was unblinded owing to a serious adverse event of suicidal ideation; 2 other patients did not have compliant postbaseline visits.||units on a scale||Standard Deviation|Mean
727497|NCT00375973|Secondary|Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) --Depression Subscale|The HADS is a self-reported instrument designed as a brief assessment tool of anxiety and depression in nonpsychiatric populations. It is a 14-item questionnaire that consistes of 2 subscales of 7 items designed to measure levels of both anxiety and depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. Higher scores indicate greater levels of anxiety or depression. A decrease in the score indicates improvement.|baseline to endpoint at 12 weeks|For the efficacy analysis, in the duloxetine group, 3 patients were not included in analysis for the following reasons: one patient's treatment group assignment was unblinded owing to a serious adverse event of suicidal ideation; 2 other patients did not have compliant postbaseline visits.||units on a scale||Standard Deviation|Mean
727498|NCT00375973|Secondary|Change From Baseline in Brief Pain Inventory (BPI) --Average Pain Severity Score|The BPI is a self-administered scale that measures the severity of pain. Pain severity is rated on a 0 [no pain] to 10 [pain as bad a you can imagine] scale. Average pain is rated over the previous 24 hours. Higher scores indicate greater pain severity. A decrease in the score indicates improvement (i.e. decrease in pain severity).|Baseline to endpoint at 12 weeks|For the efficacy analysis, in the duloxetine group, 3 patients were not included in analysis for the following reasons: one patient's treatment group assignment was unblinded owing to a serious adverse event of suicidal ideation; 2 other patients did not have compliant postbaseline visits.||units on a scale||Standard Deviation|Mean
727499|NCT00375973|Primary|Change From Baseline in Multidimensional Fatigue Inventory (MFI)--General Fatigue Subscale Score|"The MFI is a self-reported instrument that contains 20 statements covering different aspects of fatigue. The MFI consists of 5 subscales: general fatigue, physical fatigue, mental fatigue, reduced activity, and reduced concentration. Each subscale includes 4 items with 5-point Likert scales. Scores on each subscale range from 4-20 with higher scores indicating greater fatigue. A decrease in the score indicates improvement.
The general fatigue subscale (primary measure) includes general statements about tiredness, feeling rested, and overall feelings of being fit."|Baseline to endpoint at 12 weeks|For the efficacy analysis, in the duloxetine group, 3 patients were not included in analysis for the following reasons: one patient's treatment group assignment was unblinded owing to a serious adverse event of suicidal ideation; 2 other patients did not have compliant postbaseline visits.||units on a scale||Standard Deviation|Mean
727500|NCT00375999|Primary|Overall Survival||One year|||month||95% Confidence Interval|Median
727501|NCT00376168|Other Pre-specified|Change in Chitotriosidase|Change in Chitotriosidase from Baseline to Month 9|Baseline and Month 9|Intent to treat||nmol/ml/hr||Standard Deviation|Mean
727502|NCT00376168|Secondary|Change in Platelet Count|Change in Platelet count from Baseline to Month 9|Baseline and Month 9|Intent to treat||count/mm^3||Standard Deviation|Mean
727506|NCT00376220|Primary|Mean Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to the End of 8 Weeks of Therapy.|The Montgomery Asberg Depression Rating Scale measures symptoms of depression (MADRS) is a semi-structured interview rating scale for depression that assesses 10 symptoms. The scale is composed of 10 questions with a fixed 7 point scale (0-6). Total score ranges from 0-60. A higher score indicates more depressive symptoms. MADRS Response will be defined as a > 50% reduction in MADRS score from baseline.|8 weeks|Discrepancies in number of participants analyzed are due to subjects who dropped out and did not have final assessments. Imputed data was used for those participants.||units on a scale||Standard Deviation|Mean
727507|NCT00376259|Secondary|Proportion of Participants With Treatment-emergent HBV Resistance Mutations Associated With Virologic Breakthrough|The study was not completed as planned and was terminated early with agreement from the European Medicines Agency (EMEA). Patients did not receive 96 weeks of treatment. Therefore, the primary objective of evaluating virologic breakthrough by Week 96 could not be assessed. Consequently, all protocol-specified inferential analyses on the primary endpoint and all other key secondary efficacy endpoints could not be performed.|Week 96|||Proportion of Participants|||Number
727508|NCT00376259|Secondary|Percentage of Participants Achieving Specified Clinical and Laboratory Safety Criteria|Undetectable HBV DNA = HBV DNA <300 copies/ml. Serum aminotransferase (ALT) normalization is defined as ALT within normal limits on 2 successive visits for a pt. with an elevated ALT level (>=1.0 x ULN) at baseline (BL). Hepatitis B e antigen (HBeAg) loss is defined as the loss of detectable serum HBeAg in a pt. who was HBeAg +ve at BL. HBeAg seroconversion is defined as HBeAg loss with detectable HBeAb. Hepatitis B surface antigen (HBsAg) loss is defined as the loss of detectable serum HBsAg in a pt. who was HBsAg +ve at BL. HBsAg seroconversion is defined as HBsAg loss with detectable HBsAb.|12 week, 24 week, 48 week and 60 weeks|Analysis population consists of the intent-to-treat population. Analysis of data for each time point includes participants who had both baseline and post baseline observation for that timepoint.||Percentage of participants|||Number
727509|NCT00376259|Secondary|Change From Baseline in Mean Hepatitis B Virus (HBV) DNA Concentration|Efficacy was assessed by the change from baseline in mean HBV DNA concentration after 12, 24, 48 and 60 weeks of treatment.|Baseline to 12 weeks, 24 weeks, 48 weeks and 60 weeks|Analysis population consists of the intent-to-treat population. Analysis of data for each time point includes participants who had both baseline and post baseline observation.||Log10 Copies/mL||Standard Deviation|Mean
727510|NCT00376259|Primary|The Proportion of Participants Who Experienced Virologic Breakthrough|Virologic breakthrough is defined as a minimum of 1 log reduction from baseline followed by a 1 log increase from nadir on at least 2 consecutive visits including the last treatment visit.|96 Weeks|This study was terminated early and no patients received 96 weeks of treatment. Therefore, the primary objective of evaluating virologic breakthrough by Week 96 could not be assessed. Consequently, all protocol-specified inferential analyses on the primary endpoint and all other key secondary efficacy endpoints could not be performed.||Proportion of participants|||Number
727511|NCT00376363|Secondary|Visual Acuity|Snellen chart converted to logMAR (smaller logMAR values indicate better visual acuity logMar of 0 is Snellen 20/20; logMAR of 20/200 is 1.0)|5 years|"The failure rate is based on Kaplan Meier analysis of all patients enrolled (n=276).
The five-year intraocular pressure and visual acuity outcomes are based on those patients who received a five-year visit (n=174 for IOP; n=173 for visual acuity, 1 patient had missing data)"||logMAR||Standard Deviation|Mean
727512|NCT00376363|Primary|Failure Rate|5-year failure rate measured by Kaplan-Meier, defined as IOP>21 mm Hg or less than a 20% reduction below baseline on 2 consecutive study visits after 3 months, reoperation for glaucoma, loss of light perception, or removal of implant|5 years|Kaplan-Meier survival analysis||percent fail|||Number
727513|NCT00376363|Primary|Intraocular Pressure|intraocular pressure mmHg at 5 years|5 years|||mm Hg||Standard Deviation|Mean
727514|NCT00376506|Secondary|Quality of Life Patient Questionnaire|The SWAL-QOL (Swallowing Quality of Life) questionnaire was administered at baseline and every 3 months during the first year. The SWAL-QOL is a 44 item tool that measure 10 quality of life domains, i.e., food selection, burden, mental health, social functioning, fear, eating duration, eating desire, communication, sleep, and fatigue. Scores range from 0 to 100. A lower score indicates greater impairment.|Baseline and 12-months post-treatment|intention to treat||units on a scale||Standard Deviation|Mean
727515|NCT00376506|Secondary|Functional Oral Intake Scale (FOIS) for Dysphagia|The FOIS was administered at baseline and every 3 months post-treatment during the first year. The FOIS is a 7 point ordinal scale reflecting the functional oral intake of patients. A score of 1 indicates no oral nutrition; a score of 7 indicates all nutrition is taken orally.|Baseline and 12-months post-treatment|intention to treat||units on a scale||Standard Deviation|Mean
727516|NCT00376506|Primary|Swallowing Safety for 5 ml of Pudding|Every 3 months swallowing safety was measured using the Swallowing Safety Scale (SSS). The SSS measures 11 swallowing variables including: the presence of residue in the valleculae, laryngeal vestibule, and/or pyriform sinuses, the presence of penetration arising from the oropharynx and/or the hypopharynx, the number of aspiration events arising from the oropharynx and/or the hypopharynx, response to aspiration, degree of esophageal entry, presence of regurgitation, and the presence of >1 swallow per bolus. Scores range from 0 (safe swallowing) to >5 (severely impaired swallowing safety). The maximum score is infinite as the number of occurrences of aspiration is counted in the total score. A higher score on the SSS indicates reduced swallowing safety. Swallows of 10 ml thin liquid, were captured during videofluoroscopy. The SSS was scored from videotaped swallows, by speech pathologists. The raters were blinded to the identity of the patient, group, and time post training.|Baseline and 12-months post-treatment|intention to treat||Units on a scale||Standard Deviation|Mean
727517|NCT00376506|Secondary|Penetration-Aspiration Scale for 5 ml Pudding|Every 3 months swallowing was measured using the Penetration-Aspiration (P/A) Scale. The P/A scale is an 8-point interval scale measuring the depth to which material passes into the airway and the patients cough response. A score of 0 indicates no penetration or aspiration. A score of 8 indicates the presence of aspiration with no cough response. A higher score indicates reduced swallowing safety. Swallows of 5 ml pudding, were captured during videofluoroscopy. The P/A Scale was scored by speech pathologists blinded to the identity of the patient, group, and time post training, from videotaped swallows.|Baseline and 12-months post-treatment|intention to treat||units on a scale||Standard Deviation|Mean
727518|NCT00376506|Secondary|Penetration-Aspiration Scale for 10 ml Thin Liquid|Every 3 months swallowing was measured using the Penetration-Aspiration (P/A) Scale. The P/A scale is an 8-point interval scale measuring the depth to which material passes into the airway and the patients cough response. A score of 0 indicates no penetration or aspiration. A score of 8 indicates the presence of aspiration with no cough response. A higher score indicates reduced swallowing safety. Swallows of 10 ml thin liquid, were captured during videofluoroscopy. The P/A Scale was scored by speech pathologists blinded to the identity of the patient, group, and time post training, from videotaped swallows.|Baseline and 12-months post-treatment|intention to treat||units on a scale||Standard Deviation|Mean
727519|NCT00376506|Primary|Swallowing Safety for 10 ml of Thin Liquid|Every 3 months swallowing safety was measured using the Swallowing Safety Scale (SSS). The SSS measures 11 swallowing variables including: the presence of residue in the valleculae, laryngeal vestibule, and/or pyriform sinuses, the presence of penetration arising from the oropharynx and/or the hypopharynx, the number of aspiration events arising from the oropharynx and/or the hypopharynx, response to aspiration, degree of esophageal entry, presence of regurgitation, and the presence of >1 swallow per bolus. Scores range from 0 (safe swallowing) to >5 (severely impaired swallowing safety). The maximum score is infinite as the number of occurrences of aspiration is counted in the total score. A higher score on the SSS indicates reduced swallowing safety. Swallows of 10 ml thin liquid, were captured during videofluoroscopy. The SSS was scored from videotaped swallows, by speech pathologists. The raters were blinded to the identity of the patient, group, and time post training.|Baseline and 12-months post-treatment|Intention to treat||units on a scale||Standard Deviation|Mean
727520|NCT00376532|Primary|MMP-9|Serum MMP-9 levels determined by Aushon Biosystems Searchlight® Protein Array Analysis.|At time of enrollment|||pg/ml||Standard Deviation|Mean
727521|NCT00376532|Primary|MMP-2|Serum MMP-2 levels determined by Aushon Biosystems Searchlight® Protein Array Analysis.|At time of enrollment|||pg/ml||Standard Deviation|Mean
727522|NCT00376558|Secondary|Cocaine Craving, Withdrawal Symptoms, Pattern of Cocaine Use|measurement of abstinence, measured as vouchers earned and clinical appointments attended using CRA|2x/week for 24 weeks|The number of subjects was determined from previous studies using CM/CRA||dollars||Standard Deviation|Mean
727523|NCT00376558|Primary|Change From Baseline in the Binding Potential of [11C]Raclopride|The relationship between Methylphenidate-induced Dopamine Release in the Striatum (Measured by Displacement of [11C]-Raclopride by Oral Methylphenidate) and Treatment Response (Measured Using Community Reinforcement Approach and Contingency Management) was studied. Dopamine Function was assessed by evaluation of endogenous Dopamine release over the course of treatment (i.e., at 3 months as compared to baseline). Endogenous Dopamine release is inversely related to the change in binding potential (delta BPND) of [11C]raclopride, in that a negative delta BPND, or increased displacement of [11C]raclopride, reflects an increase in the release of endogenous dopamine over the course of treatment.|baseline and 3 months|Analysis for change in binding potential (binding potential difference; at baseline versus stimulant induced binding potential) was done with 24 cocaine users since one of the subjects only underwent baseline scanning. However, treatment data for all 25 cocaine users was used.||ratio||Standard Deviation|Mean
727524|NCT00376597|Secondary|Adherence to Lymphedema Prevention Exercises, Lymphedema Knowledge, Range of Motion, and Arm Strength|To characterize adherence to lymphedema prevention exercises, lymphedema knowledge and range of motion. The frequency of elastic sleeve use for heavy arm use/exercise/air travel will be reported here. Arm I did not receive a sleeve to wear, thus will not be reported.|from baseline up to 18 months|236 patients were analyzed for this endpoint.||Participants|||Count of Participants
727525|NCT00376597|Secondary|Health-related Quality of Life as Assessed by FACT-B +4 Score|To compare the health-related quality of life (FACT-B+4 score) between the two interventions. The change between baseline and month 18 for the total plus 4 score will be reported here. The total plus 4 score is an average of the physical, social, emotional, functional, FACT-G, and additional concerns sub-scales. Each sub-scale has questions ranging from 1-5. Once the average of all subscales is taken, the total plus 4 score is converted into a score out of 100. 100 being the best, 0 being the worst.|18 months|326 patients were analyzed for this measurement.||Units on a scale||Standard Deviation|Mean
727526|NCT00376597|Secondary|Agreement Between Patients' Self-report of Swelling and the Extent of Circumferential Measurement Difference Between the Treated Side and the Contralateral Arm|To assess the agreement between patients’ self-report of swelling (mild, moderation and severe) and the extent of circumferential measurement difference between treated side and the contralateral arm at the site of greatest difference. Per protocol, this analysis will include all patients and not be comparing the intervention arm with the control arm.|18 months|368 patients filled out a self assessment of swelling and were analyzed. This includes all patients that filled out a self-report of swelling, the two arms are combined because this is a comparison of actual swelling against self reported swelling, not a comparison of interventions.||Participants|||Count of Participants
727527|NCT00376597|Secondary|Change From Baseline at 18 Months in Arm Circumference at the Site of Greatest Difference|To compare the severity of lymphedema in terms of changes in arm circumference at the site of greatest difference as a continuous variable between the two interventions.|18 months|402 patients were analyzed for this endpoint.||cubic cm||Standard Deviation|Mean
727528|NCT00376597|Primary|Number of Participants Who Were Lymphedema-free 18 Months After Randomization|To test, in a group randomized controlled trial, the efficacy of this program versus education only in reducing the incidence of lymphedema. Reported here is the proportion of patients who are lymphedema-free 18 months after randomization between the two arms|18 months|554 patients completed treatment and were analyzed.||Participants|||Count of Participants
727529|NCT00376675|Secondary|Anchor-based Minimally Important Difference in SGIC Emotional State Based on Mean Changes From Baseline to Week 4 on BFI Usual Fatigue|"Perceived treatment efficacy was measured by the Subject Global Impression of Change (SGIC). The SGIC is a 3-point item in which the patient rates the change in the overall status since beginning the study drug (ranging from very much better, moderately better, a little better, about the same, a little worse, moderately worse, to very much worse). The average change in patient fatigue scores for those participants who express a perceived change of a little better via the SGIC scores were calculated. BFI usual fatigue item score was translated into 0 to 100 point scale for the analysis, with 0 (poor QOL or bad symptoms) and 100 (best QOL or no symptoms)."|Baseline and Week 4|"All participants who have provided a baseline and week 4 BFI usual fatigue scores and a perceived change of a little better via SGIC scores."||Units on scale||Standard Deviation|Mean
727530|NCT00376675|Secondary|Anchor-based Minimally Important Difference in SGIC Physical Condition Based on Mean Changes From Baseline to Week 4 on BFI Usual Fatigue|"Perceived treatment efficacy was measured by the Subject Global Impression of Change (SGIC). The SGIC is a 3-point item in which the patient rates the change in the overall status since beginning the study drug (ranging from very much better, moderately better, a little better, about the same, a little worse, moderately worse, to very much worse). The average change in patient fatigue scores for those participants who express a perceived change of a little better via the SGIC scores were calculated. BFI usual fatigue item score was translated into 0 to 100 point scale for the analysis, with 0 (poor QOL or bad symptoms) and 100 (best QOL or no symptoms)."|Baseline and Week 4|"All participants who have provided a baseline and week 4 BFI usual fatigue scores and a perceived change of a little better via SGIC scores."||Units on scale||Standard Deviation|Mean
727531|NCT00376675|Secondary|Anchor-based Minimally Important Difference in SGIC Overall Quality of Life Based on Mean Changes From Baseline to Week 4 on BFI Usual Fatigue|"Perceived treatment efficacy was measured by the Subject Global Impression of Change (SGIC). The SGIC is a 3-point item in which the patient rates the change in the overall status since beginning the study drug (ranging from very much better, moderately better, a little better, about the same, a little worse, moderately worse, to very much worse). The average change in patient fatigue scores for those participants who express a perceived change of a little better via the SGIC scores were calculated. BFI usual fatigue item score was translated into 0 to 100 point scale for the analysis, with 0 (poor QOL or bad symptoms) and 100 (best QOL or no symptoms)."|Baseline and Week 4|"All participants who have provided a baseline and week 4 BFI usual fatigue scores and a perceived change of a little better via SGIC scores."||units on a scale||Standard Deviation|Mean
727532|NCT00376675|Secondary|AUC of Other Fatigue Scores as Measured by Items of the Brief Fatigue Inventory (BFI) at Baseline and at Weeks 1-4|Area under the curve (AUC) for the other fatigue items of the BFI at baseline and at weeks 1-4 after being translated onto a 0 to 100 point scale was calculated. Higher scores are better.|Baseline to Week 4|All participants who have provided a baseline and one post-baseline BFI score were evaluable for this analysis.||units on a scale * weeks||Standard Deviation|Mean
727533|NCT00376675|Secondary|AUC of Overall Quality of Life (QOL) and QOL Domains as Measured by the Linear Analogue Self Assessment at Baseline and at Weeks 1-4|Linear Analogue Self Assessment (LASA) consists of 6 single-item numeric analogue scales. The AUC for the six-items at baseline and at weeks 1-4 after being translated onto a 0 to 100 point scale was calculated. Higher scores are better.|Baseline to Week 4|All participants who have provided a baseline and one post-baseline LASA score were evaluable for this analysis.||units on a scale * weeks||Standard Deviation|Mean
727534|NCT00376675|Secondary|AUC of Vitality as Measured by the Short Form-36 Vitality Subscale at Baseline and at Weeks 1-4|The SF-36 is a 36-item short form to measure health status in various populations. The vitality subscale is comprised of 4 items and is a measure of energy level as well as fatigue. The AUC for the vitality subscale at baseline and at weeks 1-4 after being translated onto a 0 to 100 point scale was calculated. Higher scores are better.|Baseline to Week 4|All participants who have provided a baseline and one post-baseline Vitality subscale score were evaluable for this analysis.||units on a scale * weeks||Standard Deviation|Mean
727535|NCT00376675|Secondary|AUC of Sleep Quality as Measured by the Pittsburgh Sleep Quality Index at Baseline and at Weeks 1-4|Pittsburgh Sleep Quality Index (PSQI) consists of 19 items and 7 scales. The AUC for the overall PSQI at baseline and at weeks 1-4 after being translated onto a 0 to 100 point scale was calculated. Higher scores are better.|Baseline to Week 4|All participants who have provided a baseline and one post-baseline PSQI score were evaluable for this analysis.||units on a scale * weeks||Standard Deviation|Mean
727536|NCT00376675|Secondary|Severity of Adverse Events as Measured by the Symptom Experience Diary Based on Mean Changes From Baseline to Week 4|The Symptom Experience Diary (SED) consists of 12 items. All scores were translated onto a 0-100 point scale, with 0 represent poor quality of life (QOL) or bad symptom and 100 is best QOL or no symptoms.The change in severity of adverse events was calculated as subtracting the item scores at baseline from the scores at week 4.|Baseline and Week 4|All participants who have provided a baseline and week 4 SED scores were evaluable for this analysis.||units on a scale||Standard Deviation|Mean
727537|NCT00376675|Primary|Prorated AUC of Total Fatigue as Measured by the Brief Fatigue Inventory (BFI) at Baseline and at Weeks 1-4|"The prorated area under the curve (AUC) for the usual fatigue question of the BFI at baseline and at weeks 1-4 after being translated onto a 0 (poor quality of life (QOL) or bad symptoms) to 100 (best QOL or no symptoms) point scale was calculated as the following:
For those completed 4 weeks item: AUC/4;
For those completed up to week 3 item: (AUC * 4) / 3;
For those completed up to week 2 item: AUC * 2;
For those completed up to week 1 item: AUC * 4;
The prorated AUC scores were then transformed onto 0 to 100 point scale with 0 (poor QOL or bad symptoms) and 100 (best QOL or no symptoms) for analysis."|Baseline to week 4|All participants meeting the eligibility criteria who have signed a consent form, started treatment, and provided a baseline and one post-baseline usual fatigue score were evaluable for this analysis.||units on a scale||Standard Deviation|Mean
727539|NCT00376805|Secondary|Overall Median Number of Days Patients Alive After Treatment|Calculated median number of days of survival (patients alive days after treatment).|First Day of Treatment Until Death|||Days||95% Confidence Interval|Median
727540|NCT00376805|Secondary|Number of Patients Who Died While on Study|Number of patients who died within 100 days and after 100 days of natural killer (NK) treatment with or without total body irradiation.|Within 100 days, After 100 days|||Participants|||Number
727541|NCT00376805|Secondary|Number of Patients by Disease Response|"Defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria:
Complete Response (CR: Disappearance of all target lesions
Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions
Stable Disease (SD): Neither sufficient shrinkage to qualify for PR or sufficient increase to qualify for PD
Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions of appearance of one or more new lesions
of clinical benefit (CB; stable disease for greater than 6 months."|6 Months, 1 Year|||Participants|||Number
727542|NCT00376805|Primary|Number of Patients Who Had Expansion of Natural Killer Cells|Successful Natural Killer (NK) cell expansion is defined as detection of an absolute circulating donor-derived NK cell count of >100 cells/ul of whole blood 14 days after infusion with <5% donor T and B cells in mononuclear population (in metastatic breast cancer patients).|Day 14|||Participants|||Number
727543|NCT00376935|Secondary|Number of Death From Randomization to Week 24|Number of subjects died.|From randomization to week 24|||participants|||Number
727544|NCT00376935|Secondary|Grade 3 or 4 Lab Toxicities From Randomization to Week 24|Number of subjects had a grade 3 or 4 toxicity for laboratory abnormalities. The toxicity grade scale has the following meaning: 1=mild, 2=moderate, 3=severe, 4=life-threatening.|From randomization to study week 24|||participants|||Number
727545|NCT00376935|Secondary|Change in Absolute CD4+ Lymphocyte Counts From Randomization to Day 2, Weeks 1, 2, 4, 8, 12, 24.||randomization, day 2, study weeks 1, 2, 4, 8, 12 and 24|This analysis was based on observed data only. No imputation was done for missing values. NOTE: The number of participants may vary in each study week for each treatment arm. The maximum number for each arm are showed above.||cells/mm^3||Inter-Quartile Range|Median
727546|NCT00376935|Secondary|Change in CT Thymic Index From Randomization|CT thymic index was evaluated at randomization and study week 12, ranging from 0 to 5 whereby 0 means lack of thymic tissue and an organ entirely replaced by fat, 1 means barely recognizable thymic tissue, 2 means minimal soft tissue, 3 means obvious thymic tissue, 4 means moderate thymic tissue, 5 means thymic mass of possible concern for thymoma. Change in CT thymic index from randomization to study week 12 was calculated for participants with both evaluations. The number of participants in each change group was reported by treatment arm.|randomization, study week 12|Participants who had CT thymus evaluations at both randomization and study week 12.||participants|||Number
727547|NCT00376935|Secondary|Change in Naive CD4+ Cell Counts From Randomization||randomization, day 2, study weeks 1, 2, 4, 8, 12 and 24|This analysis was based on observed data only. No imputation was done for missing values. NOTE: The number of participants may vary in each study week for each treatment arm. The maximum number for each arm are showed above.||cells/mm^3||Inter-Quartile Range|Median
727548|NCT00376935|Secondary|Grade 3 or 4 Toxicity for Signs and Symptoms From Randomization to Week 24|Number of subjects had a grade 3 or 4 toxicity for signs and symptoms. The toxicity grade scale has the following meaning: 1=mild, 2=moderate, 3=severe, 4=life-threatening.|From randomization to week 24|Numbers presented use the intent-to-treat approach (i.e. ignoring changes from randomized treatment).||participants|||Number
727549|NCT00376935|Secondary|Qualitative Hepatitis C Virus RNA||At study entry|||participants|||Number
727550|NCT00376935|Primary|Change in Absolute CD4+ Lymphocyte Counts From Baseline (Average of Pre-entry and Entry Values)|Median and inter-quartile range of the change in absolute CD4 count from baseline to study week 12 were calculated for each treatment arm. Baseline CD4+ count was defined as the average of pre-entry and entry CD4 count. If one evaluation was missing, the other one was used. If a subject missed a week 12 CD4 count evaluation, then the CD4 count evaluation obtained after starting study treatment and closest in time to week 12 (using the earlier evaluation if necessary to break a tie) was used in place of the missing week 12 evaluation.|Pre-entry, entry, study week 12|Numbers presented use the intent-to-treat.||cells/mm^3||Inter-Quartile Range|Median
727551|NCT00376948|Secondary|pAKT (Pichia Anomala Killer Toxin) and NF (Nuclear Factor)-kappaB Activation|Tumor tissue collected from paraffin|At start of study||||||
727552|NCT00376948|Secondary|Toxicity|Toxicity evaluation using NCI-CTC (Common Terminology Criteria) v.3 criteria; CBC (complete blood count) with differential white cell and platelet counts; Serum sodium, potassium, chloride, bicarbonate, AST, ALT, alkaline phosphatase, total bilirubin, blood urea nitrogen, creatinine, and albumin; Serum CA 19-9|First day of each cycle||||||
727553|NCT00376948|Secondary|Response Duration, Time to Treatment Failure, and Time to Progression|Imaging tests (CT scan, CXR, MRI or imaging studies as clinically indicated|Every 8 weeks||||||
727554|NCT00376948|Secondary|Overall Objective Response Rate (Complete and Partial Response)|Imaging tests (CT scan, CXR [Chest X-Ray], MRI or imaging studies as clinically indicated|Every 8 weeks||||||
727555|NCT00376948|Primary|Median Overall Survival Estimate||up to 17 months|||months||90% Confidence Interval|Median
727556|NCT00376948|Primary|Patients Alive||at 6 months|||participants|||Number
727557|NCT00376961|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|Assessed prior to each cycle (for Cycles 2-6), at restaging (between Cycle 6 and 7), every 3 months ( for Cycle 7-14), and at the end of protocol treatment.|Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.||Participants|||Number
727558|NCT00376961|Secondary|2-year Overall Survival in Patients Treated With Rituximab-CHOP-bortezomib Induction Therapy (RCHOP-V) Followed by Bortezomib Maintenance Therapy (VM)|Measured from date of registration to date of death due to any cause or last contact|0-2 years|All eligible patients who started treatment were included in the analysis.||percentage of participants||95% Confidence Interval|Number
727559|NCT00376961|Primary|2-year Progression-free Survival in Patients Treated With Rituximab-CHOP-bortezomib Induction Therapy (RCHOP-V) Followed by Bortezomib Maintenance Therapy (VM)|Measured from date of registration to date of first observation of relapsed or progressive disease, or death due to any cause.|0-2 years|All eligible patients who started treatment were included in the analysis||percentage of participants||95% Confidence Interval|Number
728509|NCT00367237|Secondary|Proportion of Subjects Achieving ACR50, ACR70, and PASI75 if Applicable|This is not a prespecified key secondary outcome; therefore, results will not be disclosed.|between baseline and week 16||||||
727560|NCT00376961|Secondary|Response Rate in Patients Treated With Rituximab-CHOPbortezomib Induction Therapy (R-CHOP-V) Followed by Bortezomib Maintenance Therapy(VM).|Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.|At the time of restaging (between Cycles 6 and 7), every 6 months during Cycles 7-14, and at the end of protocol treatment|All eligible patients who started treatment were included in the analysis.||participants|||Number
727561|NCT00377156|Secondary|Overall Survival|Overall survival, defined as the time from randomization until death due to any cause, was compared between the groups using stratified log-rank tests.|Up to 5 years|A survival comparison was performed on an intention-to-treat basis using the entire study population.||months||Full Range|Median
727562|NCT00377156|Secondary|Long-Term Neurocognitive Status (Long-Term Cognitive Status), as Measured by Percentage of Long-term Survivors With Cognitive Deterioration at 12 Months|Long-Term Neurocognitive Status > To ascertain in patients with one to three brain metastases whether there is better long-term neurocognitive status in patients who receive SRS alone (Arm A) compared to patients who receive SRS combined with WBRT (Arm B). Long-term survival status is defined as evaluable patients who survived for at least 12 months and had at least one cognitive assessment on or after 365 days.|From baseline to 12 months|Patients who survived for at least 12 months and had at least one cognitive assessment on or after 365 days were included in this analysis.||percentage of participants|||Number
727563|NCT00377156|Secondary|Overall Quality of Life, as Measured by Mean Change From Baseline [3 Month]|Quality of Life was assessed using the Functional Assessment of Cancer Therapy-Brain, for which the range is from 0 to 200 and higher scores indicate better QOL. The Quality of Life (QOL) scores were transformed to a 0- to 100-point scale (with 100 being most favorable), in which a 10-point change was considered clinically significant. Intergroup changes in QOL scores were compared using a 2-sample t test.|From Baseline to 3-Month Evaluation|All patients in the SRS and SRS+WBRT groups that had a baseline and 3-month QOL score were used in this analysis.||QOL score change from baseline points||95% Confidence Interval|Mean
727564|NCT00377156|Secondary|Number of Participants With Local and Distant Tumor Control up to 3 Months|Number of Participants with Local and Distant Tumor Control up to 3 months is defined as....|Up to 3 months|||Participants|||Count of Participants
727565|NCT00377156|Primary|Neurocognitive Progression as Measured by the Number of Participants With Cognitive Deterioration by 3 Months|The primary endpoint was cognitive deterioration (progression), defined as a decline of greater than 1 SD from baseline on at least 1 of 7 cognitive tests (all tests are standardized based on published norms and transformed so that higher values represent improved cognition) at the 3-month post-SRS evaluation. The number of participants who experienced cognitive deterioration by 3 months is reported for each arm below. For primary analysis of the 3-month cognitive deterioration endpoint, the Fisher exact 2-group binomial test was used to compare the proportion of evaluable patients with 3-month cognitive deterioration between the 2 groups.|3 months post radiosurgery|Patients who died prior to the 3-month evaluation, who did not return for the 3-month evaluation or a subsequent evaluation, or who did not complete the required baseline tests were excluded from the analysis population for the primary end point.||Participants|||Count of Participants
727566|NCT00377234|Secondary|Median Change From Baseline in Bone Resorption and Bone Formation Markers, Serum C-telopeptide of α-chain of Type I Collagen (CTX) and Bone Specific Alkaline Phosphatase (BSAP)|During the conduct of this study, it came to the attention of the sponsor that mislabeling of blood samples for the analysis of the bone turnover markers, serum CTX and BSAP, had occurred at more than half of the 44 clinical trial sites. As a result of this mislabeling, the bone turnover marker samples could not be assigned correctly to the two time points at which they were collected (samples collected at baseline and those collected at the crossover visit which occurred after 3 months following the start of trial treatment). Thus, the results of bone turnover markers could not be reliably assessed. Therefore, summary tables showing the mean and median change from baseline for both serum CTX and BSAP for patients randomized to Sequence A (3 months of ibandronate followed by 12 weeks of risedronate) or Sequence B (12 weeks of risedronate followed by 3 months of ibandronate) are not presented, as a valid interpretation of the data cannot be made.|3 months|Mislabeling of blood samples for analysis of bone turnover markers resulted in inability to correctly assign samples to two time points at which they were collected (baseline and crossover visit). Results could not be reliably assessed or reported.|||||
727567|NCT00377234|Secondary|Mean Change From Baseline in Bone Resorption and Bone Formation Markers, Serum C-telopeptide of α-chain of Type I Collagen (CTX) and Bone Specific Alkaline Phosphatase (BSAP)|During the conduct of this study, it came to the attention of the sponsor that mislabeling of blood samples for the analysis of the bone turnover markers, serum CTX and BSAP, had occurred at more than half of the 44 clinical trial sites. As a result of this mislabeling, the bone turnover marker samples could not be assigned correctly to the two time points at which they were collected (samples collected at baseline and those collected at the crossover visit which occurred after 3 months following the start of trial treatment). Thus, the results of bone turnover markers could not be reliably assessed. Therefore, summary tables showing the mean and median change from baseline for both serum CTX and BSAP for patients randomized to Sequence A (3 months of ibandronate followed by 12 weeks of risedronate) or Sequence B (12 weeks of risedronate followed by 3 months of ibandronate) are not presented, as a valid interpretation of the data cannot be made.|3 months|Mislabeling of blood samples for analysis of bone turnover markers resulted in inability to correctly assign samples to two time points at which they were collected (baseline and crossover visit). Results could not be reliably assessed or reported.|||||
727568|NCT00377234|Secondary|Intensity of Upper Gastrointestinal (GI) Symptoms|Patients were given a diary in which to record their upper GI events during the first 12 weeks of treatment. The diary was to be completed weekly and the occurrence of symptoms and their intensity recorded using a pre-defined list.|within 3 months|Safety analysis set||percentage of participants|||Number
727873|NCT00370682|Secondary|Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose|Incidence of abnormal dengue examination findings reported during the 31-Day (Days 0-30) post-vaccination period, per dose|31 days post-vaccination per dose|||% of subjects||95% Confidence Interval|Number
727569|NCT00377234|Secondary|Percentage of Participants Who Found Once-monthly Ibandronate to be More Convenient Than Once-weekly Risedronate|Patients who had taken at least one dose of each study medication were asked to answer a Preference Questionnaire (answered by patients before any study procedures took place at the 6 month visit or at the early termination visit). The questionnaire included three questions on the preferred dosing schedule, and one question asking which schedule was more convenient. No assistance was allowed in completing the questionnaire.|within 6 months|mITT, defined as the safety analysis set excluding those participants who did not express a preference for one treatment||percentage of participants|||Number
727570|NCT00377234|Primary|Percentage of Participants Who Preferred Ibandronate Monthly Dosing to Risedronate Weekly Dosing|Patients who had taken at least one dose of each study medication were asked to answer a Preference Questionnaire (answered by patients before any study procedures took place at the 6 month visit or at the early termination visit). The questionnaire included three questions on the preferred dosing schedule, and one question asking which schedule was more convenient. No assistance was allowed in completing the questionnaire.|at 6 months|Modified Intent to Treat (mITT), defined as the safety analysis set excluding those participants who did not express a preference for one treatment||percentage of participants|||Number
727571|NCT00377260|Primary|The Weighted Average Acute Otitis Media - Severity of Symptom (AOM-SOS) Score, According to Treatment Assignment|The AOM-SOS score is derived from parent scoring each of 7 symptoms (ear tugging, crying, irritability, difficulty sleeping, diminished activity, diminished appetite & fever) associated with AOM as 0, 1 or 2 (none, a little, a lot). The AOM-SOS was administered twice daily the first 3 days of follow-up, then daily for 4 additional days. Symptom burden for each child is determined by calculating the weighted average of symptom scores post-enrollment over the first 7 days of therapy. Scores are weighted by 1/k, where k is the number of post-enrollment assessments taken on that day.|During the first 7 days of therapy|The analysis was ITT. The number of participants equals the number of children with at least one AOM-SOS score post-enrollment in the first 7 days of therapy. The score was based on diaries completed at home by the child's parent.||AOM-SOS score||Standard Error|Mean
727572|NCT00377260|Secondary|The Mean Score Representing Parental Satisfaction With the Study Medication As Recorded at the Follow-up Visit According to Treatment Assignment|Parents were asked to circle the expression that best represented their satisfaction with the study medication. These expressions have an assigned value: Very dissatisfied = 1, Somewhat dissatisfied = 2, Neither satisfied nor dissatisfied = 3, Somewhat satisfied = 4 and Very satisfied = 5.|Follow-up visit. The mean day for this visit was 22.8.|The analysis was ITT. The number of participants equals the number of children whose parent reported a satisfaction score at the follow-up visit.||parental satisfaction score||Standard Deviation|Mean
727573|NCT00377260|Secondary|The Mean Score Representing Parental Satisfaction With the Study Medication As Recorded at the End-of-therapy Visit According to Treatment Assignment|Parents were asked to circle the expression that best represented their satisfaction with the study medication. These expressions have an assigned value: Very dissatisfied = 1, Somewhat dissatisfied = 2, Neither satisfied nor dissatisfied = 3, Somewhat satisfied = 4 and Very satisfied = 5.|End-of-therapy visit. The mean day for this visit was 11.6.|The analysis was ITT. The number of participants equals the number of children whose parent reported a satisfaction score at the end-of-therapy visit.||parental satisfaction score||Standard Deviation|Mean
727574|NCT00377260|Secondary|The Mean Score Representing Parental Satisfaction With the Study Medication As Recorded at the On-therapy Visit According to Treatment Assignment|Parents were asked to circle the expression that best represented their satisfaction with the study medication. These expressions have an assigned value: Very dissatisfied = 1, Somewhat dissatisfied = 2, Neither satisfied nor dissatisfied = 3, Somewhat satisfied = 4 and Very satisfied = 5.|On-therapy visit. The mean day for this visit was 5.0.|The analysis was ITT. The number of participants equals the number of children whose parent reported a satisfaction score at the on-therapy visit.||parental satisfaction score||Standard Deviation|Mean
727575|NCT00377260|Secondary|The Total Number of Visits, Summed Across All Participants, at Which a Family Member Reported Making Special Daycare Arrangements According to Treatment Assignment|At each visit, parent or parents were asked if their child's illness had caused them to make alternative daycare arrangements. The total number of visits is summed across all participants in the respective treatment arms.|This was assessed at each study visit, i.e. Day 4-5, Day 10-12, Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this latter visit was 22.8.|The analysis was ITT. The participants for analysis were the children with follow-up assessment visits.||visits|||Number
727576|NCT00377260|Secondary|The Total Number of Visits, Summed Across All Participants, at Which a Family Member Reported Having Missed Work According to Treatment Assignment|At each visit, parent or parents were asked if their child's illness had caused either parent to miss a day or partial day of work. The total number of visits is summed across all participants in the respective treatment arms.|This was assessed at each study visit, i.e. Day 4-5, Day 10-12, Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this latter visit was 22.8.|The analysis was ITT. The participants for analysis were the children with follow-up assessment visits.||visits|||Number
727577|NCT00377260|Secondary|The Mean Number of Antibiotic Prescriptions, Exclusive of Study Medication, According to Treatment Assignment|This is the number of times, in the course of the study, a child required treatment with an antibiotic other than the blinded study medication.|This was assessed at each study visit, i.e. Day 4-5, Day 10-12, Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this latter visit was 22.8.|The analysis was ITT. The participants for analysis were the children with follow-up.||antibiotic prescriptions||Standard Deviation|Mean
727578|NCT00377260|Primary|The Time to Resolution of Symptoms, Defined as Acute Otitis Media-Severity of Symptoms (AOM-SOS) Score of 0 or 1 on Two Consecutive Occasions, According to Treatment Assignment|Time to resolution of symptoms is defined as the time from randomization until a child's AOM-SOS score reaches <= 1 on two consecutive occasions. The parent rated each of 7 symptoms (ear tugging, crying, irritability, difficulty sleeping, diminished activity, diminished appetite & fever) as 0, 1 or 2 (none, a little, a lot) & recorded the ratings in a diary following enrollment on Day 1, twice daily Days 2 & 3, & once daily Days 4-7. Each set of ratings was summed to obtain an AOM-SOS score. The maximum possible was 14 and the minimum 0. A score >=3 was required to be enrolled in the study.|The first 7 days on therapy|||participants|||Number
727579|NCT00377260|Primary|The Time to Resolution of Symptoms, Defined as Acute Otitis Media-Severity of Symptoms (AOM-SOS) Score of 0 or 1, According to Treatment Assignment|Time to resolution of symptoms is defined as the time from randomization until a child's AOM-SOS score reaches 0 or 1. The parent rated each of 7 symptoms (ear tugging, crying, irritability, difficulty sleeping, diminished activity, diminished appetite & fever) as 0, 1 or 2 (none, a little, a lot) and recorded the ratings in a diary following enrollment on Day 1, twice daily Days 2 and 3, then once daily Days 4-7. Each set of ratings was summed to obtain an AOM-SOS score. The maximum possible score was 14 and the minimum was 0. A score >=3 was required to be enrolled in the study.|The first 7 days on therapy|The analysis was ITT. The number of participants is equal to the number of children randomized.||participants|||Number
727580|NCT00377260|Secondary|The Mean Number of Emergency Room Visits According to Treatment Assignment|At each visit we asked parents if they had to take their child to the emergency department. We also reviewed medical records to assure even more accurate reporting.|This was assessed at each study visit, i.e. Day 4-5, Day 10-12, Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this latter visit was 22.8.|The analysis was ITT. The participants for analysis were the children with follow-up assessment visits.||visits to ER||Standard Deviation|Mean
727581|NCT00377260|Secondary|The Mean Number of Visits to a Primary Care Provider (PCP) According to Treatment Assignment|At each visit parents were asked if they had taken their child to his/her primary care physician since the last contact. Medical records were also reviewed.|This was assessed at each study visit, i.e. Day 4-5, Day 10-12, Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this latter visit was 22.8.|The analysis was ITT. The participants for analysis were the children with follow-up assessment visits.||visits to PCP||Standard Deviation|Mean
727582|NCT00377260|Secondary|The Probability of Middle Ear Effusion, Based on an Algorithm That Estimates the Probability of Middle Ear Effusion From an Interpretable Tympanographic Configuration, at the Follow-up Visit According to Treatment Assignment|For tympanograms with values for height, middle-ear air pressure, and gradient width, the probability of Middle Ear Effusion (MEE) was estimated by applying an algorithm developed by Smith et al. If the tympanogram was flat and had no printed values for the 3 fields, the probability of MEE was estimated to be .802 based on the proportion of ears with flat graphs that were found otoscopically, by Smith et al, to have MEE.|Follow-up visit. The mean day for this visit was 22.8.|The analysis was ITT. The number of participants equals the number of children for which at least one ear has an interpretable tympanogram at the follow-up visit.||probability of effusion||Standard Deviation|Mean
727583|NCT00377260|Secondary|The Probability of Middle Ear Effusion, Based on an Algorithm That Estimates the Probability of Middle Ear Effusion From an Interpretable Tympanographic Configuration, at the End-of-therapy Visit According to Treatment Assignment|For tympanograms with values for height, middle-ear air pressure, and gradient width, the probability of Middle Ear Effusion (MEE) was estimated by applying an algorithm developed by Smith et al. If the tympanogram was flat and had no printed values for the 3 fields, the probability of MEE was estimated to be .802 based on the proportion of ears with flat graphs that were found otoscopically, by Smith et al, to have MEE.|End-of-therapy visit. The mean day for this visit was 11.6.|The analysis was ITT. The number of participants equals the number of children for which at least one ear has an interpretable tympanogram at the end-of-therapy visit.||probability of effusion||Standard Deviation|Mean
727584|NCT00377260|Secondary|The Probability of Middle Ear Effusion, Based on an Algorithm That Estimates the Probability of Middle Ear Effusion From an Interpretable Tympanographic Configuration, at the On-therapy Visit According to Treatment Assignment|For tympanograms with values for height, middle-ear air pressure, and gradient width, the probability of Middle Ear Effusion (MEE) was estimated by applying an algorithm developed by Smith et al. If the tympanogram was flat and had no printed values for the 3 fields, the probability of MEE was estimated to be .802 based on the proportion of ears with flat graphs that were found otoscopically, by Smith et al, to have MEE.|On-therapy visit. The mean day for this visit was 5.0.|The analysis was ITT. The number of participants equals the number of children for which at least one ear has an interpretable tympanogram at the on-therapy visit.||probability of effusion||Standard Deviation|Mean
727585|NCT00377260|Secondary|The Distribution of Children With Nasopharyngeal (NP) Colonization With Penicillin-susceptible Streptococcus Pneumoniae (S. pn) at the Follow-up Visit||Follow-up visit. The mean day for this visit was 22.8.|The analysis was ITT. The number of participants equals the number of children with NP culture results and results regarding penicillin susceptibility at the follow-up visit.||participants|||Number
727586|NCT00377260|Secondary|The Distribution of Children With Nasopharyngeal (NP) Colonization With AOM Pathogens at the Follow-up Visit According to Treatment Assignment|AOM pathogens are defined as Streptococcus Pneumoniae or Haemophilus Influenzae or Moraxella Catarrhalis or Streptococcus Pyogenes. Nasopharyngeal cultures were obtained at the follow-up visit.|Follow-up visit. The mean day for this visit was 22.8.|The analysis was ITT. The number of participants equals the number of children with NP culture results at the follow-up visit.||participant|||Number
727587|NCT00377260|Secondary|The Distribution of Children With Nasopharyngeal (NP) Colonization With Penicillin-susceptible Streptococcus Pneumoniae (S. pn) at the End-of-therapy Visit According to Treatment Assignment||End-of-therapy visit. The mean day for this visit was 11.6.|The analysis was ITT. The number of participants equals the number of children with NP culture results and results regarding penicillin susceptibility at the end-of-therapy visit.||participants|||Number
727588|NCT00377260|Secondary|The Distribution of Children With Nasopharyngeal (NP) Colonization With AOM Pathogens at the End-of-therapy Visit According to Treatment Assignment|AOM pathogens are defined as Streptococcus Pneumoniae or Haemophilus Influenzae or Moraxella Catarrhalis or Streptococcus Pyogenes. Nasopharyngeal cultures were obtained at the end of therapy visit.|End-of-therapy visit. The mean day for this visit was 11.6.|The analysis was ITT. The number of participants equals the number of children with NP culture results at the end-of-therapy visit.||participants|||Number
727641|NCT00377572|Secondary|Percent Prevalence: Prescribed Rescue Beta 2 Agonists|Percent of participants prescribed long-acting beta 2 agonists to maintain asthma control. Data represent an average of those collected in the time period (weeks 12-60), where at least one value was available in this assessment period and at baseline for a participant. Results values are model predicted numbers, (e.g.,odds ratios converted to percentages).|Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.|Intent-to-treat||percent prevalence|||Number
727589|NCT00377260|Secondary|The Distribution of Children With Observed or Parent Reported Adverse Events or Complications According to Treatment Assignment|Analysis was limited to those adverse events identified as being associated with either the study medication or the antimicrobials administered to children who were treatment failures or as being a complication of acute otitis media.|We monitored children and queried parents regarding adverse events at each study visit, i.e. Day 4-5, Day 10-12, and Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this visit was 22.8.|The analysis was ITT. The number of participants equals the number of children randomized.||participants|||Number
727590|NCT00377260|Secondary|The Mean Number of Times Analgesic Medication Was Administered to the Child According to Treatment Assignment|The parents were asked to complete a memory aid for the first 10 days of the study. One item asked them to record medications administered to the child in addition to the study medication. The data presented shows the mean number of times analgesic, i.e. ibuprofen or acetaminophen, was administered.|The first 10 days of follow-up|The analysis was ITT. The participants for analysis were the children with follow-up.||times analgesic was administered||Standard Deviation|Mean
727591|NCT00377260|Secondary|The Distribution of Children Developing Worsening Symptoms Prior to Receiving 72 Hours of Study Medication According to Treatment Assignment|The parent rated each of 7 symptoms (ear tugging, crying, irritability, difficulty sleeping, diminished activity, diminished appetite & fever) as 0, 1 or 2 (none, a little, a lot) and recorded the ratings in a diary following enrollment on Day 1 and twice daily Days 2 and 3. Each set of ratings was summed to obtain an Acute Otitis Media-Severity of Symptoms (AOM-SOS) score. We compared a child's AOM-SOS scores in the first 72 hours to his/her score at enrollment to determine if a child's symptoms got worse (score increased) or remained unchanged or improved (score remained same or decreased).|Before receiving 72 hours of study medication|The analysis was ITT. The number of participants equals the number of children with follow-up whose parent(s) recorded AM and/or PM symptom scores in the first 3 days of treatment.||Participants|||Number
727592|NCT00377260|Secondary|The Mean Acute Otitis Media - Severity of Symptom (AOM-SOS) Score, Post-enrollment, Over the First 7 Days of Therapy According to Treatment Assignment|The parent rated each of 7 symptoms (ear tugging, crying, irritability, difficulty sleeping, diminished activity, diminished appetite & fever) as 0, 1 or 2 (none, a little, a lot) and recorded the ratings in a diary following enrollment on Day 1, twice daily Days 2 and 3, then once daily Days 4-7. Each set of ratings was summed to obtain an AOM-SOS score as a measure of symptom burden. The maximum possible score was 14 and the minimum was 0.|During the first 7 days of therapy|The analysis was ITT. The number of participants equals the number of children with at least one AOM-SOS score post-enrollment in the first 7 days of therapy. The score was based on AM and PM diaries completed at home by the child's parent.||AOM-SOS score||Standard Deviation|Mean
727593|NCT00377260|Secondary|The Distribution of Clinical Failures by the End-of-therapy Visit According to Treatment Assignment|Clinical failure by the end of therapy visit is defined as failure to achieve complete or virtually complete resolution of symptoms and of otoscopic signs, but without regard to the persistence of middle ear effusion.|End-of-therapy visit. The mean day for this visit was 11.6.|The analysis was ITT. The number of participants equals the number of children evaluated post therapy plus the number of children who met the criteria for clinical failure prior to the end of therapy.||participants|||Number
727594|NCT00377260|Secondary|The Distribution of Clinical Failures by the On-therapy Visit According to Treatment Assignment|Clinical failure by the on-therapy visit is defined as either failure to achieve substantial improvement in symptoms, or worsening of otoscopic signs, or both.|On-therapy visit. The mean day for this visit was 5.0.|The analysis was ITT. The number of participants equals the number of children followed at least 72 hours after the initial dose of study medication plus the number of children meeting the criteria for clinical failure less than 72 hours after the initial dose of study medication.||participants|||Number
727595|NCT00377299|Secondary|Stroop Color Word Test|The Stroop Color Word Test measures the individual's ability to separate the word and color naming stimuli thus the ability to sort information from the environment and selectively react to this information. The scoring is a measure of time to complete 100 items and the numbers of items that can be completed. THe scores are converted into T-scores which have a mean of 50 and a standard deviation of 10.|12 weeks|||T score||Standard Error|Mean
727596|NCT00377299|Secondary|Hopkins Auditory Verbal Learning Test (HVLT)|The Hopkins Auditory Verbal Learning Test (HVLT) is a measure of cognition (memory/recall). Raw scores are derived for Total Recall, Delayed Recall, Retention (% retained), and a Recognition Discrimination Index. Raw scores are calculated into T-scores. T-scores are standardized scores on each dimension for each type. A score of 50 represents the mean. A difference of 10 from the mean indicates a difference of one standard deviation. Thus, a score of 60 is one standard deviation above the mean, while a score of 30 is two standard deviations below the mean.|12 weeks|ITT includes those returning for at least one post baseline visit. LOCF used for end point data.||T score||Standard Error|Mean
727597|NCT00377299|Secondary|Amphetamine Use|Participant reported days per 7-day week of methamphetamine use.|12 weeks|ITT includes those returning for at least one post baseline visit. LOCF used for end point data.||days per week||Standard Error|Mean
727598|NCT00377299|Secondary|Amphetamine Craving|Visual Analog Scale (VAS) assessing Methamphetamine craving with a 1-100 scale.Higher values on the VAS scale indicate a higher Methamphetamine craving(worse outcome).|12 Weeks|ITT includes those returning for at least one post baseline visit. LOCF used for end point data.||scores on a scale||Standard Error|Mean
727599|NCT00377299|Primary|Depression Symptoms|Inventory of Depressive Symptomatology-Clinician Rated (IDS-C), (a clinician-administered depression scale) is used to assess the severity of depressive symptoms.Scores can range from 0 to 84. The higher the score, the worse the depressive symptoms(worse outcome).|12 weeks|The intent to treat (ITT) group includes all who returned for at least one post baseline visit. Analysis uses Last Observation Carried Forward (LOCF) method.||scores on a scale||Standard Error|Mean
727600|NCT00377312|Secondary|Bone Specific Alkaline Phosphatase (BSAP)|% change from baseline|baseline, daily, one week follow-up|||% change from baseline||Standard Error|Mean
727601|NCT00377312|Secondary|Amino-terminal Peptides of Procollagen- 1(P1NP)|% change from baseline|baseline, daily, one week follow-up|||% change from baseline||Standard Error|Mean
727602|NCT00377312|Secondary|Serum Carboxy-terminal of Collagen- 1(sCTX)|% change from baseline|baseline, daily, one week follow-up|||% change from baseline||Standard Error|Mean
727612|NCT00377312|Primary|Participants With Dose Limiting Toxicity|DLT was defined as achieving one major criterion or two minor criteria rated at ≥ 2 on a scale of 0-5. The major criteria were defined as symptomatic orthostatic hypotension (systolic BP fall >30 mm/hg), tachycardia (pulse > 120), hypertension (systolic BP >160 mm/hg on 2 occasions), hypercalcemia (serum calcium ≥ 12 mg/dl), and hypophosphatemia (serum phosphorous < 1.5 mg/dl). Minor criteria included symptoms such as flushing, nausea, abdominal or muscle cramps, dizziness, lightheadedness, palpitations, etc.|12 hours after the infusion was started then q 8 hours for 7 days|||participants|||Number
727613|NCT00377364|Secondary|Asthma Control Questionnaire|This is a seven item assessment of symptoms pertinent to asthma management, including day and nighttime symptoms; activity limitation; use of prn bronchodilators; a physiological measure of asthma (spirometry), forced expiratory volume in 1 second percent predicted (FEV1% predicted), which is the percentile of FEV1 compared to normal controls matched for age, height, gender, and race, in the scoring. Total mean is interpreted on a scale between 0 (asthma completely controlled) and 6 (asthma severely uncontrolled).|Exit (Day 3 or Day 7)|ITT defined as any post baseline visit. Last Observation Carried Forward.||units on a scale||Standard Deviation|Mean
727614|NCT00377364|Secondary|Asthma Control Questionnaire (ACQ)|This is a seven item assessment of symptoms pertinent to asthma management, including day and nighttime symptoms; activity limitation; use of prn bronchodilators; a physiological measure of asthma (spirometry), forced expiratory volume in 1 second percent predicted (FEV1% predicted), which is the percentile of FEV1 compared to normal controls matched for age, height, gender, and race, in the scoring. Total mean is interpreted on a scale between 0 (asthma completely controlled) and 6 (asthma severely uncontrolled).|Baseline|||units on a scale||Standard Deviation|Mean
727615|NCT00377364|Primary|Young Mania Rating Scale (YMRS)|This is an 11-item, observer rated measure of the severity of manic symptoms on a 5 point scale. The total score indicates overall severity of mania with a minimum of zero (indicating normalcy) and a maximum of 60 (indicating very severe).|Exit (Day 3 or Day 7)|ITT defined as any post baseline visit. Last Observation Carried Forward.||units on a scale||Standard Deviation|Mean
727616|NCT00377364|Primary|Young Mania Rating Scale (YMRS)|This is an 11-item, observer rated measure of the severity of manic symptoms on a 5 point scale. The total score indicates overall severity of mania with a minimum of zero (indicating normalcy) and a maximum of 60 (indicating very severe).|Baseline|||units on a scale||Standard Deviation|Mean
727617|NCT00377364|Primary|Hamilton Rating Scale for Depression (HRSD-17)|The assessment is a clinician administered rating of depression with 17 questions. The total score is indicates level of depression within the following ranges: none (0-5), mild (6-10), moderate (11-15), severe (16-20), and very severe (21+).|Exit (Day 3 or Day 7)|ITT defined as any post baseline visit. Last Observation Carried Forward.||units on a scale||Standard Deviation|Mean
727618|NCT00377364|Secondary|Internal State Scale - Activation (ISS-ACT)|Activation subscale assesses (hypo)manic symptoms. There are 16 questions on the total ISS, each rated on a series of visual analogue scale (VAS) items consisting of statement followed by a 100 mm line with anchor points at 0 and 100. The 16 questions divide into four subscales measuring activation; depression, global psychopathology, and well being. Depression Index (DI): Scores for items 7 and 9 are added to give a DI score ranging from 0-200 with 0 being absence of depressive symptoms and 200 indicating severe depressive symptoms. Well-Being Index (WB): Scores for items 3, 5 and 15 are added to give a WB score ranging form 0-300, with >125 indicating euthymia. Activation Index (ACT): Scores for items 6, 8, 10, 12 and 13 are added to give an ACT score ranging from 0-500, with >155 indicating mania. Perceived Conflict Index (PC): Scores for items 1, 2, 4, 11 and 14 are added to give a PC score ranging from 0-500, with higher scores indicating greater severity of psychopathology.|Exit (Day 3 or Day 7)|ITT defined as any post baseline visit. Last Observation Carried Forward.||units on a scale||Standard Deviation|Mean
727619|NCT00377364|Secondary|Internal State Scale - Activation (ISS-ACT)|Activation subscale assesses (hypo)manic symptoms. There are 16 questions on the total ISS, each rated on a series of visual analogue scale (VAS) items consisting of statement followed by a 100 mm line with anchor points at 0 and 100. The 16 questions divide into four subscales measuring activation; depression, global psychopathology, and well being. Depression Index (DI): Scores for items 7 and 9 are added to give a DI score ranging from 0-200 with 0 being absence of depressive symptoms and 200 indicating severe depressive symptoms. Well-Being Index (WB): Scores for items 3, 5 and 15 are added to give a WB score ranging form 0-300, with >125 indicating euthymia. Activation Index (ACT): Scores for items 6, 8, 10, 12 and 13 are added to give an ACT score ranging from 0-500, with >155 indicating mania. Perceived Conflict Index (PC): Scores for items 1, 2, 4, 11 and 14 are added to give a PC score ranging from 0-500, with higher scores indicating greater severity of psychopathology.|Baseline|||units on a scale||Standard Deviation|Mean
727620|NCT00377364|Primary|Hamilton Rating Scale for Depression (HRSD-17)|The assessment is a clinician administered rating of depression with 17 questions. The total score is indicates level of depression within the following ranges: none (0-5), mild (6-10), moderate (11-15), severe (16-20), and very severe (21+).|Baseline|||units on a scale||Standard Deviation|Mean
727621|NCT00377364|Primary|Rey Auditory Verbal Learning Task (RAVLT)|This is a measure of declarative memory (associated with the hippocampus), using the mean number of words (0-75) recalled from Trials I-V of the RAVLT ± the standard deviation. The assessement was conducted using the same procedures as at baseline. RAVLT total score of ≥ 40 words on trials 1-5(from a range of 0 to 75 words possible)suggests relatively normal memory prior to prednisone therapy.|Exit (Day 3 or Day 7)|ITT defined as any post baseline visit. Last Observation Carried Forward.||words||Standard Deviation|Mean
727622|NCT00377364|Primary|Rey Auditory Verbal Learning Test (RAVLT)|This is a measure of declarative memory (associated with the hippocampus). The test consists of 15 nouns read aloud for five consecutive trials with each trial followed by a free-recall trial. Following the fifth trial, an interference list of 15 different words is presented followed by a free-recall trial of that list. Delayed recall of the first list is tested immediately following the interference list and after a 20-minute delay. A recognition test of 50 words including the 15 original words is presented after the delayed recall. RAVLT total score of ≥ 40 words on trials 1-5(from a range of 0 to 75 words possible)suggests relatively normal memory prior to prednisone therapy.|Baseline|||words||Standard Deviation|Mean
727814|NCT00369941|Secondary|Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 156|Antiretroviral activity was evaluated for participants who achieved HIV RNA level <50 copies/mL at Week 156.|156 Weeks|All participants who took study medication and had HIV RNA tests performed were included in the analysis.||Participants|||Number
727623|NCT00377403|Primary|SNOT-16 Score (Sino-Nasal Outcomes Test) at Day 3|The Sino-Nasal Outcomes Test (SNOT-16) assesses disease-specific quality of life for acute and chronic rhinosinusitis. This brief instrument assesses 16 sinus-related symptoms and was administered by phone. The respondent reported how much they were bothered by each item considering both its severity and frequency. Response options include no problem (0), mild or slight problem (1), moderate problem (2), severe problem (3). The SNOT-16 score is the mean score from all 16 items and ranges from 0 (minimal impact) to 3 (significant impact).|4 days|We analysed all participants for whom we had data at Day 3. We were unable to complete the telephone interview with 11 subjects.||Units on a scale||Standard Deviation|Mean
727624|NCT00377429|Secondary|Number of Participants With no Residual Disease at 3 Months After Catumaxomab Treatment Via 3rd-look Laparoscopy or Laparotomy (These Procedures Are Optional)||3 months|Only 1 patient received 3rd-look laparoscopy/laparotomy as determined by the investigator and no residual disease was found.||participants|||Number
727625|NCT00377429|Secondary|Number of Participants Who Survived (Post-study at 24 Month Visit)|Number of participants who survived (post-study at 24 month visit) is the number of participants who did not die|2 years|Post study full analysis set||participants|||Number
727626|NCT00377429|Secondary|Median Time of Progression-free Survival in Weeks (Post-study for 24 Months)||2 years|Post study full analysis set||weeks||Full Range|Median
727627|NCT00377429|Secondary|Number of Participants With no Residual Disease Prior to Catumaxomab Treatment Via 2nd-look Laparoscopy or Laparotomy (These Procedures Are Optional)||Baseline|2nd look laparoscopy/laparotomy||Participants|||Number
727628|NCT00377429|Secondary|Number of Participants With Negative (Undetectable) Humoral Immune Responses to Catumaxomab Therapy|Humoral immune response of participants with functional immune system to catumaxomab can provide important information regarding why a therapy may work for some participants and not for others. An undetectable humoral response by itself does not necessarily imply lack of study drug activity. Humoral response is one of the possible selected measurements of the study drug activity at a time point in the study.|2 months|Full analysis population||Participants|||Number
727629|NCT00377429|Primary|Number of Participants Who Completed a 4-dose Series of Catumaxomab Infusions (Defined as 10-20-50-150 Micrograms) Within 21 Days||21 days|Treated population||Participants|||Number
727630|NCT00377455|Secondary|Quality of Life (QOL)|QOL is measured using the Short Form 36 Health Survey (SF-36, which measures health on eight dimensions: general health perception, physical and social functioning, role limitations by physical or emotional problems, mental health, vitality, and bodily pain. For each dimension items are coded, summed, and transformed on to a scale from 0 (worst health) to 100 (best health).|16 weeks||||||
727631|NCT00377455|Secondary|Endothelin-1(ET-1) Level|From saved serum|16 weeks||||||
727632|NCT00377455|Secondary|Brain Natriuretic Peptide (BNP) Level|Serum BNP level|16 weeks||||||
727633|NCT00377455|Secondary|6-minute Walk Distance|The distance walked during a 6-minute walk test.|16 weeks||||||
727634|NCT00377455|Primary|Total Exercise Time on the Exercise Echocardiogram Using the Standard Bruce Stress Protocol.||This will be determined after 16 weeks on the study medication.||||||
727635|NCT00377520|Secondary|Number of Participants With Adverse Events by Grade (Measures of Toxicity)|Adverse events were graded using the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) for defining and grading specific adverse events. A grading (severity) scale is provided for each adverse event term. Grades range from 0 (none) to 5 (death). The worst grade event per cycle is reported.|every 21-day cycle (up to 24 months)|||participants|||Number
727636|NCT00377520|Primary|Tumor Response|"Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve (respond), stay the same (stable), or worsen (progression) during treatment. Complete response (CR) = disappearance of all target lesions; Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions; Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions; Stable disease (SD) = small changes that do not meet above criteria."|baseline to measured progressive disease (up to 24 months)|||participants|||Number
727637|NCT00377572|Secondary|Paediatric Asthma Quality of Life Questionnaire (PAQLQ) Overall Score|"Asthma-specific quality of life (QOL) validated tool designed for children 7 to 17 years of age. PAQLQ measures functional problems that are most troublesome to children with asthma. PAQLQ has 23 questions in 3 domains (activity limitation=5, emotional function=8, symptoms=10). Patients responded to each question on a 7-point Likert scale. Overall PAQLQ score is mean of 23 questions; each domain score is mean of questions in that domain. Minimum possible score is 1 (maximum impairment); maximum possible score is 7 (no impairment). Actual scores ranged from 2.1 to 7.
PAQLQ scores were available for 338 of 419 (81%) of study participants, 170 of whom were in the Omalizumab (Xolair) + Conventional Therapy arm."|Week 60|Intent-to-treat||units on a scale||Standard Deviation|Mean
727638|NCT00377572|Secondary|Asthma Caregiver’s Quality of Life Questionnaire (PACQLQ) Overall Score|"Asthma-Specific Quality of Life (QOL) Measure . The PACQLQ is a validated tool that measures limitations and anxieties faced by primary caregivers of children with asthma. Scores are calculated as the mean score within two domains of questions (re: activity limitation and emotional function) and overall scores represent the mean across all questions. The use of the PACQLQ is valid for use in the caretakers of children ages 7 to 17 years of age. Higher scores indicate better quality of life. Minimum possible score is 1 (maximum impairment); maximum possible score is 7 (no impairment). The range of actual scores were a minimum of 2.4 and a maximum of 7.
Method: Caretaker self-report. PACQLQ scores were available for 320 of 419 (76%) of study participant caretakers (159 in the Omalizumab (Xolair) + Conventional Therapy arm)."|Week 60|Intent-to-treat||units on a scale||Standard Deviation|Mean
727639|NCT00377572|Secondary|Percent Prevalence: Asthma Exacerbations|Percent participants with >=1 exacerbations. An exacerbation was defined as a prednisone burst (a minimum of 20 mg per day of prednisone, or the equivalent, taken for any 3 of 5 consecutive days) or hospitalization. Results values are model predicted numbers, (e.g.,odds ratios converted to percentages).|Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.|Intent-to-treat||percent prevalence|||Number
727888|NCT00370994|Primary|Numeric Pain Rating Score|Numeric rating scale represented 0 with no pain and 10 with the worst pain imaginable|3, 6, 12, 18 and 24 months post treatment.|Sample size is calculated based on reduction of NRS. A 25% clinical difference change of 1.15.||units on a scale||Standard Deviation|Mean
727642|NCT00377572|Secondary|Dose Inhaled Corticosteroids (Glucocorticoids)|Prescribed dose (mcg/day) of inhaled glucocorticoids to maintain asthma control. The dose of inhaled glucocorticoids was converted to the budesonide-equivalent dose. Data represent an average of those collected in the time period (weeks 12-60), where at least one value was available in this assessment period and at baseline for a participant.|Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.|Intent-to-treat||mcg/day||Standard Error|Least Squares Mean
727643|NCT00377572|Secondary|Percent Prevalence: Treatment Step Level 4 Through 6 (Severe Asthma)|Steps were established, per the National Asthma Education and Prevention Program Expert Panel Report 3 guidelines. Steps 1-2 apply to mild asthma, 3 to moderate asthma, and 4-6 to severe asthma. At Step 0, the recommendation is for no asthma-control medication or albuterol as needed; at 1, budesonide 180 mcg once a day; at 2, budesonide 180 mcg twice a day; at 3, budesonide 360 mcg twice a day; at 4, fluticasone–salmeterol (Advair, GlaxoSmithKline) 250 mcg fluticasone and 50 mcg salmeterol twice a day; at 5, Advair 250 mcg and 50 mcg twice a day plus montelukast once a day; and at 6, Advair 500 mcg and 50 mcg twice a day plus montelukast once a day. (The doses for montelukast are 5 mg per day for those <=14 years old and 10 mg per day for those >=15 years.) Data represent an average of those in the time period, where at least one value was available in this period and at baseline for a participant. Results values are model predicted numbers,(e.g, odds ratios converted to percentages).|Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment|Intent-to-treat||percent prevalence|||Number
727644|NCT00377572|Secondary|Percent Prevalence: Treatment Step Level 1 or 2 (Mild Asthma)|Treatment steps were established, per the National Asthma Education and Prevention Program Expert Panel Report 3 guidelines. Steps 1-2 apply to mild asthma, 3 to moderate asthma, and 4-6 to severe asthma. At Step 0, the recommendation is for no asthma-control medication or albuterol as needed; at 1, budesonide 180 mcg once a day; at 2, budesonide 180 mcg twice a day; at 3, budesonide 360 mcg twice a day; at 4, fluticasone–salmeterol (Advair, GlaxoSmithKline) 250 mcg fluticasone and 50 mcg salmeterol twice a day; at 5, Advair 250 mcg and 50 mcg twice a day plus montelukast once a day; and at 6, Advair 500 mcg and 50 mcg twice a day plus montelukast once a day. (The doses for montelukast are 5 mg per day for those <=14 years old and 10 mg per day for those >=15 years.) Data represent an average of those in the time period, where at >/= 1 value was available in this period and at baseline for a participant; results are model predicted numbers (e.g.,odds ratios converted to percentages).|Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment|Intent-to-treat||percent prevalence|||Number
727645|NCT00377572|Secondary|Percent Adherence to Asthma Medication|Adherence to the study regimen and other asthma treatments, assessed as percent of expected dose taken, by means of study interviews and study physician corroboration every 3 months. Adherence data as an outcome were available in 384 of the 419 participants, 193 of whom were in the Omalizumab (Xolair) + Conventional Therapy arm. Data represent an average of those collected in the time period (weeks 12-60), where at least one value was available in this assessment period and at baseline for a participant.|Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment|Intent-to-treat||percentage of expected dose taken||Standard Error|Least Squares Mean
727646|NCT00377572|Secondary|Exhaled Nitric Oxide|Exhaled nitric oxide is a biomarker of airway inflammation. Measurement (in parts per billion,ppb) of exhaled nitric oxide (eNO) prior to spirometry, employing a technique modified after Silkoff et al (1997) and following American Thoracic Society guidelines for eNO assessment (American Thoracic Society, 1999). Nitric oxide concentrations were measured using a rapid-response chemiluminescent analyzer (NIOX™ System, Aerocrine, Sweden) which has a response time of < 700 ms for 10-90% full scale. The Food and Drug Administration has approved this device for clinical application in asthma management. Data represent an average of those collected in the time period (weeks 12-60), where at least one value was available in this assessment period and at baseline for a participant.|Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.|Intent-to-treat||ppb||Standard Error|Least Squares Mean
727647|NCT00377572|Secondary|FEV1/FVC Ratio|"The FEV1 (forced expiratory volume 1))/ FVC (forced vital capacity) ratio is used to evaluate airways obstructions since pure restrictive ventilatory defects cause an equal reduction in the FEV1 and the FVC. An FEV1/FVC ratio below 80% indicates airflow obstruction. Normal FEV1/FVC: 8 – 19 years of age=85%.
FEV1/FVC ratio data as an outcome measure were available in 363 of the 419 participants, 190 of whom were in the Omalizumab (Xolair) + Conventional Therapy arm. Data represent an average of those collected in the time period (weeks 12-60), where at least one value was available in this assessment period and at baseline for a participant."|Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.|Intent-to-treat||Ratio (x100)||Standard Error|Least Squares Mean
727648|NCT00377572|Secondary|Forced Expiratory Volume in 1 Second (FEV1) % Predicted|FEV1 is air volume exhaled in 1 second during spirometry. For the trial, mild asthma is defined as pre-bronchodilator FEV1 ≥80% predicted, requiring no/low-moderate dose of inhaled glucocorticoids; moderate asthma and severe asthma, respectively, as pre-bronchodilator FEV1 <80% predicted requiring the same glucocorticoids as mild asthma and FEV1 <80% predicted requiring high-dose inhaled glucocorticoids (with/without continuous oral glucocorticoids) or uncontrolled despite treatment. FEV1 % of predicted is FEV1 converted to a percentage of normal, based on height, weight, and race. FEV1 percent predicted data as an outcome measure were available in 363 of the 419 participants, 190 of whom were in the Omalizumab (Xolair) + Conventional Therapy arm. Data represent an average of those collected in the time period (weeks 12-60), where at least one value was available in this assessment period and at baseline for a participant.|Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.|Intent-to-treat||Percent||Standard Error|Least Squares Mean
727659|NCT00369317|Secondary|Prevalence of of GATA1 Mutations of DS Patients < 4 Years of Age at Diagnosis|Proportion of participants having GATA1 mutation among patients with phenotype data available.|At baseline and at the end of therapy (intensification) or disease relapse|Ineligible patients (n=1) are excluded. Patients without available or evaluable phenotype data are excluded (n=158). Data are not available at end of therapy or relapse.||Proportion of participants|||Number
727660|NCT00369317|Secondary|Prevalence of Leukemia Phenotype of DS Patients < 4 Years of Age at Diagnosis by Flow Cytometry|Proportion of participants having megakaryoblastic subtype (AMkL) phenotype among patients with phenotype data available.|At the start of therapy|Ineligible patients (n=1) are excluded. Patients without available or evaluable phenotype data are excluded (n=40). Data are not available at end of therapy or relapse.||Proportion of participants|||Number
727649|NCT00377572|Secondary|Asthma Control Test (ACT) Score|The Asthma Control Test (ACT) is a validated tool to assess overall asthma control (over the last 4 weeks) in patients >= 12 years of age. It is a questionnaire comprised of 5 questions assessing: asthma symptoms, use of rescue medications, and the impact of asthma on everyday functioning. All questions are scored on a 5-point Likert scale, with a higher score indicating better control. All scores were added together to calculate a total score. Total scores can range from 5 to 25. A score of 19 or less is indicative of asthma that is not well controlled. The minimally important difference for ACT is 3 points. ACT scores as an outcome measure were available in 150 of the 419 participants, 77 of whom were in the Omalizumab (Xolair) + Conventional Therapy arm. Data represent an average of those collected in the time period (weeks 12-60), where at least one value was available in this assessment period and at baseline for a participant.|Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.|Intent-to-treat||ACT score||Standard Error|Least Squares Mean
727650|NCT00377572|Secondary|Child Asthma Control Test (C-ACT) Score|The Childhood Asthma Control Test (C-ACT) is a validated tool to assess overall asthma control (over the last 4 weeks) in patients ages 4 to 11 years. Scores can range from 0 to 27. A score of 19 or less is indicative of asthma that is not well controlled. The minimally important difference in C-ACT scores is not defined. C-ACT scores were available as an outcome measure in 236 of the 419 participants, 118 of whom were in the Omalizumab (Xolair) + Conventional Therapy arm. Data represent an average of those collected in the time period (weeks 12-60), where at least one value was available in this assessment period and at baseline for a participant.|Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of treatment.|Intent-to-treat||C-ACT score||Standard Error|Least Squares Mean
727651|NCT00377572|Secondary|Economic Outcome: Number of Missed Work Days by Caretaker Due to Asthma|The number of work days missed by the caretaker due to the study participant’s asthma was available for 138 of 419 (33%) study participant caretakers. Source of data: caretaker self-report. Data represent an average of those collected in the time period (weeks 12-60).|Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.|Intent-to-treat||Days||Standard Error|Least Squares Mean
727652|NCT00377572|Secondary|Economic Outcome: Comparison of Number of Missed School Days Due to Asthma|The number of school days missed was available for 307 of the 419 (73%) study participants, of which 152 were in the Omalizumab (Xolair) + Conventional Therapy arm. Source of data: caretaker/participant self-report. Data represent an average of those collected in the time period (weeks 12-60), where at least one value was available in this assessment period and at baseline for a participant.|Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.|Intent-to-treat||Days||Standard Error|Least Squares Mean
727653|NCT00377572|Primary|Maximum Number of Asthma Symptom Days|Maximum symptom days was calculated as the largest of the following variables: number of days with wheezing, chest tightness, or cough; number of nights of sleep disturbance; and number of days when activities were affected. This symptom scale ranges from 0 to 14 days per a 2-week look-back period. A higher score reflected a greater number of asthma symptoms. Data represent an average of those collected in the time period (weeks 12-60), where at least one value was available in this assessment period and at baseline for a participant.|Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.|Intent-to-treat||Days||Standard Error|Least Squares Mean
727654|NCT00369317|Secondary|Gene Expression Profiles by Microarrays|A hierarchical clustering algorithm is used to assemble the genes into a dendrogram or tree structure with branches containing genes with similar patterns of expression. This ordered representation can be graphically displayed with colors that reflect the qualitative and quantitative relationships of the expressed genes.|At baseline and at the time of relapse (if available)|The Microarray analysis secondary outcome is not available because the number of specimens with good quality wasn’t sufficient to yield meaningful results.|||||
727655|NCT00369317|Secondary|Cytarabine Drug Sensitivity by R-Strip (MicroMath) Curve Fitting Program|Mean and standard deviation of half-life of elimination. Specimen draws were performed only with dose 1, day 1 of induction II of AraC. First sample drawn pre-infusion, then drawn 30 mins prior to the end of the infusion, and then drawn for 6 time periods post infusion up to 8 hours post infusion (and before the 2nd dose of AraC). Results are based from these multiple time points on Day 1 of Induction II only.|Days 1, 2, 8, and 9 of induction II|Ineligible patients (n=1) are excluded. Patients without available data for half-life of elimination (n=146) are excluded.||Mean minutes||Standard Deviation|Mean
727656|NCT00369317|Secondary|Cytarabine Drug Sensitivity by R-Strip (MicroMath) Curve Fitting Program|Mean and standard deviation of area under the concentration time curve. Specimen draws were performed only with dose 1, day 1 of induction II of AraC. First sample drawn pre-infusion, then drawn 30 mins prior to the end of the infusion, and then drawn for 6 time periods post infusion up to 8 hours post infusion (and before the 2nd dose of AraC). Results are based from these multiple time points on Day 1 of Induction II only.|Days 1, 2, 8, and 9 of induction II|Ineligible patients (n=1) are excluded. Patients without available data for area under the concentration time curve (n=146) are excluded.||Mean micromolar x minutes||Standard Deviation|Mean
727657|NCT00369317|Secondary|Cytarabine Drug Sensitivity by R-Strip (MicroMath) Curve Fitting Program|Mean and standard deviation of peak plasma concentration. Specimen draws were performed only with dose 1, day 1 of induction II of AraC. First sample drawn pre-infusion, then drawn 30 mins prior to the end of the infusion, and then drawn for 6 time periods post infusion up to 8 hours post infusion (and before the 2nd dose of AraC). Results are based from these multiple time points on Day 1 of Induction II only.|Days 1, 2, 8, and 9 of induction II|Ineligible patients (n=1) are excluded. Patients without available data from peak plasma concentration (n=146) are excluded.||Mean micromolar||Standard Deviation|Mean
727658|NCT00369317|Secondary|Proportions of Patients in Morphologic Remission With Positive MRD by Flow Cytometry|Proportion of participants in complete remission by morphology and with positive MRD by flow cytometry among patients having evaluable remission and MRD assessment.|After Induction I therapy (day 28 from start of therapy)|Ineligible patients (n=1) are excluded. Patients without available MRD at end of Induction I (n=58) or not evaluable for morphologic remission assessment (n=7) are excluded. MRD data are not available at end of Induction IV or after completion of Intensification therapy.||Proportion of participants|||Number
727704|NCT00369590|Secondary|Overall Survival|all patients alive as of the last contact were censored for survival on the basis of that contact date|3 years|The 3 pts in Arm 2 were treated at 2nd recurrence and were excluded from final efficacy analysis||weeks||Full Range|Median
727661|NCT00369317|Secondary|Percentage of Patients Experiencing Grade 3 or 4 Toxicity Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0|Proportion of participants with at least one grade 3 or higher adverse event during therapy.|From the beginning of induction therapy to the end of intensification therapy|Ineligible patients (n=1) are excluded.||Proportion of participants|||Number
727662|NCT00369317|Secondary|Induction Remission Rate|Proportion of participants with a remission after four courses of Induction therapy.|End of induction therapy (day 112)|Ineligible (n=1) patients are excluded. Patients who withdrew from therapy before completing 4 courses of Induction and did not die or relapse are not evaluable (n=9) for Induction remission rate.||Proportion of participants|||Number
727663|NCT00369317|Primary|Overall Survival (OS) at 3 Years||Time from study entry to death, assessed at 3 years.|Ineligible patients are excluded from analyses of overall survival and event free survival.||percentage||95% Confidence Interval|Number
727664|NCT00369317|Primary|Event-free Survival (EFS) at 3 Years||Time from study entry to induction failure, relapse, or death assessed at 3 years.|Ineligible patients are excluded from analyses of event free survival and overall survival.||percentage||95% Confidence Interval|Number
727665|NCT00369343|Secondary|Discontinuation-Emergent Signs and Symptoms (DESS) Total Score|DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of “new symptoms” and “old (but worse) symptoms” (1) and 0 for “old and unchanged symptom,” “absent,” or “old symptom but improved” for a total possible range of 0 to 43. A higher score indicates more symptoms.|6 months|Open-label (OL) safety population: Patients completed double-blind and continued in OL with ≥1 dose study drug. Excluded patients lost to follow-up and discontinued with <4 wks therapy. Patients analyzed varied by time (0mg, 100mg, 200mg): Early Termination (n=9,98,207); Taper week 1 (n=4,76,193); Taper week 2 (n=5,75,195); Post-taper (n=5,71,192)||units on scale||Standard Deviation|Mean
727666|NCT00369343|Secondary|Change in Dimension Health State EuroQol (EQ-5D) Score From Open Label Baseline to 6 Months|EQ-5D is a standardized, subject-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point visual analog scale (0=worst, 100=best). EQ-5D summary index is obtained with a formula that weights each level of the dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health). Change=8 week score minus baseline score.|open label baseline to 6 months|Open-label phase safety population: All patients who completed the double-blind phase, elected to continue treatment in the open-label phase, and received at least 1 dose of study drug in the open-label phase. One patient did not have a baseline and at least 1 on therapy assessment.||units on scale||Standard Deviation|Mean
727667|NCT00369343|Secondary|Change in Hamilton Psychiatric Rating Scale for Anxiety (HAM-A) Score From Open Label Baseline to 6 Months|The HAM-A is a standardized, clinician-administered rating scale that assesses 14 items characteristically associated with major anxiety disorders. Items are scaled 0 - 4 (0=none and 4=very severe), with a maximum total score of 56. Change= Final Evaluation mean HAM-A score minus baseline mean score.|open label baseline to 6 months|Open-label phase safety population: All patients who completed the double-blind phase, elected to continue treatment in the open-label phase, and received at least 1 dose of study drug in the open-label phase. One patient did not have a baseline and at least 1 on therapy assessment.||units on scale||Standard Deviation|Mean
727668|NCT00369343|Secondary|Percentage of Patients Achieving a Response to Treatment|A responder is defined as a patient with ≥ 50% decrease from baseline on Hamilton Psychiatric Rating Scale for Depression - 17-item (HAM-D17) score. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total score of 50.|6 months|Open-label phase safety population: All patients who completed the double-blind phase, elected to continue treatment in the open-label phase, and received at least 1 dose of study drug in the open-label phase. One patient did not have a baseline and at least 1 on therapy assessment.||percentage of patients responding|||Number
727669|NCT00369343|Secondary|Percentage of Patients Achieving Remission|Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total s core of 50.|6 months|Open-label phase safety population: All patients who completed the double-blind phase, elected to continue treatment in the open-label phase, and received at least 1 dose of study drug in the open-label phase. One patient did not have a baseline and at least 1 on therapy assessment.||percentage of patients|||Number
727670|NCT00369343|Secondary|Clinical Global Impression Improvement (CGI-I) Score|CGI-I is a global rating scale that measures disease improvement. Using a 7-point scale the clinician rates how much the patient’s illness has improved or worsened relative to the baseline status (1= very much improved; 7= very much worse)|6 months|Open-label phase safety population: All patients who completed the double-blind phase, elected to continue treatment in the open-label phase, and received at least 1 dose of study drug in the open-label phase.||units on scale||Standard Deviation|Mean
727671|NCT00369343|Secondary|Change in Hamilton Psychiatric Rating Scale for Depression (HAM-D17) Score From Open Label Baseline to 6 Months|HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total s core of 50. Change= Final Evaluation mean HAM-D17 minus baseline mean HAM-D17.|open label baseline and 6 months|Open-label phase safety population: All patients who completed the double-blind phase, elected to continue treatment in the open-label phase, and received at least 1 dose of study drug in the open-label phase. One patient did not have a baseline and at least 1 on therapy assessment.||units on scale||Standard Deviation|Mean
727735|NCT00369824|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling.|During the 7-day period following each vaccination|Analysis was performed on the Total Vaccinated cohort including all vaccinated subjects receiving one dose at least||subjects|||Number
727672|NCT00369343|Secondary|Change in Dimension Health State EuroQol (EQ-5D) Score From Baseline to Week 8|EQ-5D is a standardized, subject-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point visual analog scale (0=worst, 100=best). EQ-5D summary index is obtained with a formula that weights each level of the dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health). Change=8 week score minus baseline score.|Baseline to 8 weeks|Double-blind phase; modified intent to treat population, which included all randomized patients with a baseline HAM-D17 score ≥18, took ≥1 dose of study drug and had ≥1 post-baseline HAM-D17 evaluation.||units on scale||Standard Error|Mean
727673|NCT00369343|Secondary|Change in Hamilton Psychiatric Rating Scale for Anxiety (HAM-A) Score From Baseline to Week 8|The HAM-A is a standardized, clinician-administered rating scale that assesses 14 items characteristically associated with major anxiety disorders. Items are scaled 0 - 4 (0=none and 4=very severe), with a maximum total score of 56. Change= 8 week adjusted mean HAM-A score minus baseline adjusted mean score.|Baseline to 8 weeks|Double-blind phase; modified intent to treat population, which included all randomized patients with a baseline HAM-D17 score ≥18, took ≥1 dose of study drug and had ≥1 post-baseline HAM-D17 evaluation. Mixed model repeated measures (MMRM) modeling included all available observed data for each patient and no missing values were imputed.||units on scale||Standard Error|Mean
727674|NCT00369343|Secondary|Percentage of Patients Achieving Response to Treatment|A response is defined as ≥ 50% decrease from baseline on Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total score of 50.|8 weeks|Double-blind phase, modified intent to treat population, which included all randomized patients with a baseline HAM-D17 score ≥18, took ≥1 dose of study drug and had ≥1 post-baseline HAM-D17 evaluation. Missing data handled by last observation carried forward (LOCF).||percentage of patients|||Number
727675|NCT00369343|Secondary|Percentage of Patients Achieving Remission|Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total score of 50.|8 weeks|Double-blind phase, modified intent to treat population, which included all randomized patients with a baseline HAM-D17 score ≥18, took ≥1 dose of study drug and had ≥1 post-baseline HAM-D17 evaluation. Missing data handled by last observation carried forward (LOCF).||percentage of patients|||Number
727676|NCT00369343|Secondary|Percentage of Patients With Each Clinical Global Impression Improvement (CGI-I) Score|CGI-I is a global rating scale that measures disease improvement. Using a 7-point scale, the clinician rates how much the patient’s illness has improved or worsened relative to the baseline status (1= very much improved; 7= very much worse).|8 weeks|Double-blind phase, modified intent to treat population, which included all randomized patients with a baseline HAM-D17 score ≥18, took ≥1 dose of study drug and had ≥1 post-baseline HAM-D17 evaluation. Missing data handled by last observation carried forward (LOCF).||percentage of patients|||Number
727677|NCT00369343|Primary|Change in Hamilton Psychiatric Rating Scale for Depression (HAM-D17) Score From Baseline to Week 8.|HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total score of 50. Change= 8 week adjusted mean HAM-D17 minus baseline adjusted mean HAM-D17|Baseline to 8 weeks|Double-blind phase; modified intent to treat population, which included all randomized patients with a baseline HAM-D17 score ≥18, who took ≥1 dose of study drug and had ≥1 post-baseline HAM-D17 evaluation. Mixed model repeated measures (MMRM) modeling included all available observed data for each patient and no missing values were imputed.||units on scale||Standard Error|Mean
727678|NCT00369382|Secondary|Number of Participants in Sirolimus Treatment Group Requiring Conversion Back to CNI Therapy||Baseline up to Week 52|Safety population.||Participants|||Number
727679|NCT00369382|Secondary|Number of Participants Requiring Antibody Use in Treatment of Acute Rejection|Number of participants requiring antilymphocyte antibody therapy with suspected or biopsy-proven, steroid-resistant, acute rejection with or without hemodynamic compromise. Acute rejection based on ISHLT 1990 criteria: all rejections Grade 3A or higher, any rejection accompanied by hemodynamic compromise, or any rejection requiring treatment. ISHLT Grade 3A or higher included: Multifocal aggressive infiltrates and/or myocyte damage, diffuse inflammatory process with necrosis, diffuse aggressive polymorphus with necrosis, increased infiltrates, and changes in edema, hemorrhage, or vasculitis.|Baseline to Week 52|Safety population; N=participants who had biopsy-confirmed acute rejection.||Participants|||Number
727680|NCT00369382|Secondary|Time to First Acute Rejection|Time from baseline to first biopsy-confirmed acute rejection defined as any of the following (based on ISHLT 1990 criteria): all rejections Grade 3A or higher, any rejection accompanied by hemodynamic compromise, or any rejection requiring treatment. ISHLT Grade 3A or higher included: Multifocal aggressive infiltrates and/or myocyte damage, diffuse inflammatory process with necrosis, diffuse aggressive polymorphus with necrosis, increased infiltrates, and changes in edema, hemorrhage, or vasculitis.|Baseline to Week 52|Safety population; not analyzed because actual start date of rejection was unknown for those diagnosed by site protocol (SOC) biopsy and protocol-required biopsy.||Weeks|||Number
727681|NCT00369382|Secondary|Number of Participants With Biopsy-confirmed Acute Rejection by Severity|Severity of acute rejection summarized using revised 2005 ISHLT criteria. Grade 0R: no rejection, Grade 1R: Focal (perivascular or interstitial) infiltrate without necrosis, diffuse but sparse infiltrate without necrosis, or one focus only with aggressive infiltration and/or focal myocyte damage, Grade 2R:Multifocal aggressive infiltrates and/or myocyte damage, and Grade 3R:Diffuse inflammatory process with necrosis, or diffuse aggressive polymorphous with necrosis, increased infiltrate, changes in edema, hemorrhage and vasculitis.|Baseline to Week 52|Safety population||Participants|||Number
727922|NCT00371254|Secondary|Number of Participants With Abnormalities (Grade 1 or 2) in Prothrombin Time (PT)|PT is a measure of the clotting ability of the blood. Abnormalities were graded according to the NCI CTC, version 3.0: Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life-threatening and 5=death.|Throughout study, from start of study drug therapy up to 30 days after the last dose.|All treated participants||participants|||Number
727682|NCT00369382|Secondary|Number of Participants With Acute Rejection|Based on International Society for Heart and Lung Transplantation [ISHLT] 1990 criteria: rejections Grade 3A or higher, rejection accompanied by hemodynamic compromise or requiring treatment. Grade 3A or higher included: multifocal aggressive infiltrates and/or myocyte damage, diffuse inflammatory process with necrosis, diffuse aggressive polymorphus with necrosis, increased infiltrates, and changes in edema, hemorrhage, or vasculitis. Biopsies performed for clinically suspected rejection (for cause), site’s standard of care (site protocol biopsy), or protocol mandated.|Baseline to Week 52|Safety population; n=number of participants analyzed for the specified type of biopsy.||Participants|||Number
727683|NCT00369382|Secondary|Overall Survival (OS)|Survival time from the start of study treatment to date of death due to any cause, censored at the last visit if no death. Death was determined from the Death report. The distribution of time to death was to be estimated using Kaplan-Meier method and compared between treatment groups with a proportional hazard model. The number and percent of survival at 6 and 12 months were to be reported.|Baseline until death (up to Week 56)|Safety population: all randomized participants who received at least 1 dose of study medication; not analyzed by Kaplan-Meier because number of events limited to 2 deaths in the sirolimus group.||Weeks|||Number
727684|NCT00369382|Secondary|Annual Change in Calculated Creatinine Clearance (Cockcroft-Gault Equation)|The change in creatinine clearance over time assessed using the random coefficient slope of the regression line with creatinine clearance as the dependent variable and study day as the independent variable. Time points calculated as study days, relative to time of randomization of study medication. Observed data multiplied by a scale factor of 365 to express an annual change.|Baseline to discontinuation (up to Week 52)|ITT; N=participants with all measurements required for calculated creatinine clearance. All observed data up to the point of discontinuation of the study were used.||mL/min/1.73m^2||95% Confidence Interval|Number
727685|NCT00369382|Secondary|Serum Creatinine Level at Baseline|Serum creatinine is an indicator of kidney function. Creatinine is a substance formed from the metabolism of creatine, commonly found in blood, urine, and muscle tissue. It is removed from the blood by the kidneys and excreted in urine.|Baseline|ITT.||mcmol/L||Standard Deviation|Mean
727686|NCT00369382|Secondary|Change From Baseline in Serum Creatinine Level at 4, 16, 24, 32, 40, and 52 Weeks Post-randomization|Serum creatinine is an indicator of kidney function. Creatinine is a substance formed from the metabolism of creatine, commonly found in blood, urine, and muscle tissue. It is removed from the blood by the kidneys and excreted in urine. Normal adult blood levels of creatinine=45 to 90 micromoles per liter (mcmol/L) for females, 60 to 110 mcmol/L for males, however normal values are age-dependent. Change from baseline=creatinine level at Week x minus baseline level where higher scores represented decreased kidney function. Least squares mean adjusted for treatment group and center.|Baseline and Weeks 4, 16, 24, 32, 40, and 52|ITT, All available data (on-therapy and off-therapy) were included; LOCF for data points missing due to skipped visits or participant withdrawal from study.||mcmol/L||Standard Error|Least Squares Mean
727687|NCT00369382|Secondary|Calculated Creatinine Clearance (Modification of Diet in Renal Disease [MDRD] Equation) at Baseline|Creatinine clearance calculated using MDRD equation. Calculated CC: method to approximate kidney function. It measures rate creatinine (substance formed from metabolism of creatine) is cleared from blood by kidneys. Normal adult creatinine clearance is ≥ 90 mL/min/1.73m^2.|Baseline|ITT.||mL/min/1.73m^2||Standard Deviation|Mean
727688|NCT00369382|Secondary|Change From Baseline in Calculated Creatinine Clearance (Modification of Diet in Renal Disease [MDRD] Equation) at 4, 16, 24, 32, 40 and 52 Weeks Post-randomization|Creatinine clearance calculated using MDRD equation. Normal adult creatinine clearance is ≥ 90 mL/min/1.73m^2. Change from baseline=CC at Week X minus CC at baseline where higher scores represented improved renal function. Least squares mean adjusted for baseline calculated creatinine clearance (MDRD) and center.|Baseline and Weeks 4, 16, 24, 32, 40 and 52|ITT; All available data (on-therapy and off-therapy) were included; LOCF for data points missing due to skipped visits or participant withdrawal from study.||mL/min/1.73m^2||Standard Error|Least Squares Mean
727689|NCT00369382|Secondary|Change From Baseline in Calculated Creatinine Clearance (Cockcroft-Gault Equation) at 4, 16, 24, 32, and 40 Weeks Post-randomization|Creatinine Clearance (CC) calculated using Cockcroft-Gault equation, adjusted for body surface area. Calculated CC: method to approximate kidney function. It measures rate creatinine (substance formed from metabolism of creatine) is cleared from blood by kidneys. Normal adult creatinine clearance is ≥ 90 mL/min/1.73m^2. Change from baseline=CC at Week X minus CC at baseline where higher scores represented improved renal function; Least squares mean adjusted for baseline calculated creatinine clearance and center.|Baseline and Weeks 4, 16, 24, 32, and 40|ITT; All available data (on-therapy and off-therapy) were included; LOCF for data points missing due to skipped visits or participant withdrawal from study; N=participants with all measurements required for calculated creatinine clearance.||mL/min/1.73m^2||Standard Error|Least Squares Mean
727690|NCT00369382|Primary|Calculated Creatinine Clearance (Cockcroft-Gault Equation) at Baseline|Creatinine clearance at baseline calculated using Cockcroft-Gault equation and adjusted for body surface area. Calculated CC: method to approximate kidney function. It measures rate creatinine (substance formed from metabolism of creatine) is cleared from blood by kidneys. Normal adult creatinine clearance is ≥ 90 mL/min/1.73m^2.|Baseline|ITT; N=participants with all measurements required for calculated creatinine clearance.||mL/min/1.73m^2||Standard Deviation|Mean
727691|NCT00369382|Primary|Change From Baseline in Calculated Creatinine Clearance (Cockcroft-Gault Equation) at 52 Weeks Post-randomization|Creatinine Clearance (CC) calculated using Cockcroft-Gault equation, adjusted for body surface area. Calculated CC: method to approximate kidney function. It measures rate creatinine (substance formed from metabolism of creatine) is cleared from blood by kidneys. Normal adult creatinine clearance is greater than or equal to (≥) 90 milliliters per minute per 1.73 meters squared (mL/min/1.73m^2). Change from baseline=CC at Week 52 minus CC at baseline where higher scores represented improved renal function; Least squares mean adjusted for baseline calculated creatinine clearance and center.|Baseline and Week 52|Intent-to-Treat (ITT) Population: all randomized participants; all available data (on-therapy and off-therapy) included; Last observation carried forward (LOCF) for data missing due to skipped visits or participant withdrawal from study. Number of participants analyzed (N)=those with all measurements required for calculated creatinine clearance.||mL/min/1.73m^2||Standard Error|Least Squares Mean
728583|NCT00368290|Primary|Percent of Participants Reporting no Cocaine Craving|Percent of participants reporting no cocaine craving based on Brief Substance Craving Scale (BSCS) - a 4 point likert scale.|8 weeks|||Percent of participants|||Number
727692|NCT00369486|Secondary|Central Subfield Thickness <250 Microns From Baseline Through 34 Weeks|Primary criterion for retreatment is central subfield thickness >=250 microns. Central subfield thickness of <250 microns indicates no need for retreatment. Change in Central Subfield Thickening from Baseline measured on Optical Coherence Tomography (OCT). OCT images were obtained at each visit following pupil dilation by a certified operator using the OCT3 machine (Carl Zeiss Meditec Inc., Dublin, CA). Scans were 6 mm length and included the 6 radial line pattern for quantitative measures and the cross hair pattern (6-12 to 9-3 o'clock) for qualitative assessment of retinal morphology.|4, 8, 17, 34 weeks|The correlation between eyes of patients who have two study eyes (one eye in the laser group and one eye in either of the Triamcinolone groups) was accounted for in the primary analysis. Primary analyses excluded patients who missed the visit||eyes|||Number
727693|NCT00369486|Secondary|Reduction of ≥ 50% in Retinal Thickening in the Central Subfield From Baseline Through 34 Weeks|Number of eyes that had a reduction in central subfield retinal thickness by ≥ 50% at each follow-up. Change in Central Subfield Thickening from Baseline measured on Optical Coherence Tomography (OCT). OCT images were obtained at each visit following pupil dilation by a certified operator using the OCT3 machine (Carl Zeiss Meditec Inc., Dublin, CA). Scans were 6 mm length and included the 6 radial line pattern for quantitative measures and the cross hair pattern (6-12 to 9-3 o'clock) for qualitative assessment of retinal morphology.|4, 8, 17, 34 weeks|The correlation between eyes of patients who have two study eyes (one eye in the laser group and one eye in either of the Triamcinolone groups) was accounted for in the primary analysis. Primary analyses excluded patients who missed the visit||eyes|Participants||Number
727694|NCT00369486|Primary|Mean Visual Acuity Letter Score at Each Follow-up Visit|Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) mean visual acuity letter score: best value = 97; letter score worst value = 0|4, 8, 17, and 34 weeks|The primary analysis included all randomized eyes and followed the intent-to-treat analysis. The correlation between eyes of patients who have two study eyes (one eye in the laser group and one eye in either of the Triamcinolone groups) was accounted for in the primary analysis. Primary analyses excluded patients who missed the visit.||letter score|Participants|Standard Deviation|Mean
727695|NCT00369486|Primary|Change in Visual Acuity Letter Score From Baseline Through 34 Weeks|Change in visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the electronic Early Treatment for Diabetic Retinopathy Study(E-ETDRS) technique. Letter score best value = 97 and worst value = 0; an increase in a letter score by 10 is considered clinically significant. Negative changes represent a worsening in visual acuity.|4, 8, 17, and 34 weeks|The primary analysis included all randomized eyes and followed the intent-to-treat analysis. The correlation between eyes of patients who have two study eyes (one eye in the laser group and one eye in either of the Triamcinolone groups) was accounted for in the primary analysis. Primary analyses excluded patients who missed the visit.||letter score|Participants|Standard Deviation|Mean
727696|NCT00369486|Secondary|Persistence/Recurrence of Diabetic Macular Edema (DME) Either Retreated or Meeting Criteria for Retreatment at 17 Weeks|Number of eyes that were retreated at 17 weeks. According to the protocol, primary criterion for retreatment was central subfield thickness >=250 microns or macular edema was still present according to the investigator's judgment.|17 weeks|The correlation between eyes of patients who have two study eyes (one eye in the laser group and one eye in either of the Triamcinolone groups) was accounted for in the primary analysis. Primary analyses excluded patients who missed the visit||eyes|Participants||Number
727697|NCT00369486|Primary|Change in Central Subfield Thickening From Baseline Through 34 Weeks|Change in Central Subfield Thickening from Baseline measured on Optical Coherence Tomography (OCT). OCT images were obtained at each visit following pupil dilation by a certified operator using the OCT3 machine (Carl Zeiss Meditec Inc., Dublin, CA). Scans were 6 mm length and included the 6 radial line pattern for quantitative measures and the cross hair pattern (6-12 to 9-3 o'clock) for qualitative assessment of retinal morphology. Negative changes represent a decrease in retinal thickening.|4, 8, 17, 34 weeks|Last Observation Carried Forward was used. The correlation between eyes of patients who have two study eyes (one eye in the laser group and one eye in either of the Triamcinolone groups) was accounted for in the primary analysis. Primary analyses excluded patients who missed the visit.||microns|Participants|Standard Deviation|Mean
727698|NCT00369512|Primary|Number of Patients With Recurrence at 2 Years|Rate of recurrence at 2 years.|2 years|||participants|||Number
727699|NCT00369512|Primary|Median Time to Cancer Recurrence|Per protocol, patients were followed every 3 months for recurrent disease by physical exam and imaging (MRI/CT). Recurrence, in most cases, is detected during routine history/physical exam. If disease was detected during follow-up, every attempt was made to obtain pathological confirmation of recurrence.|2 years|||months||Full Range|Median
727700|NCT00369512|Primary|Toxicities Associated With Combined Radiotherapy and Erlotinib Treatments.|Number of gradeable toxicities (via CTCAE manual) experienced by patients on this protocol--number of events|2 years|||number of adverse events|||Number
727701|NCT00369564|Secondary|Ability to Receive All Scheduled Doses of Vincristine|We will determine if a greater proportion of patients receiving l-glutamic acid hydrochloride are able to receive 100% of their scheduled doses of vincristine as compared to those in the placebo control group|10 weeks||||||
727702|NCT00369564|Secondary|Frequency and Types of Neurotoxicity Observed|Frequency and types of neurotoxicity observed among those children treated with l-glutamic acid hydrochloride as compared to those who are in the placebo control group|10 weeks||||||
727703|NCT00369564|Primary|Neurotoxicity as Measured by a Scored Neurologic Examination at Baseline, 5 Weeks, and 10 Weeks (if Applicable)|A neurological exam will be completed at baseline and at study week 5 for both strata. An additional exam at week 10 will be done for patients in Stratum 1. Additional exams will be done at any time if the treating oncologist deems it clinically necessary . Neurotoxicity will be scored using a standardized neurological exam form developed for the study that is based on the Modified “Balis” Pediatric Scale of Peripheral Neuropathies. Treatment groups will be compared with respect to the proportion experiencing a grade 2 or higher toxicity from the following list of neurologic toxicities captured on the Neurologic Exam Form including sensory neuropathy, motor neuropathy, laryngeal nerve, constipation/neuro-constipation, jaw pain, or other specified abnormalities noted by the attending physician. Percentage of patients with one or more Grade 2 or higher noted neurotoxicity symptoms on any item in the Balis scale will compared between arms.|10 weeks|Patients reporting baseline and post-baseline observation||percentage of participants||95% Confidence Interval|Number
727705|NCT00369590|Secondary|Progression Free Survival (PFS) Rate for Subjects With Radiographic Response|"pts with confirmed radiographic response and their rate of progression (PFS).
Response determined by modified MacDonald Criteria Complete Response (CR): Complete disappearance of all measurable and evaluable disease, no new lesions. no steroids Partial Response (PR): Greater than or equal to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable lesions. no new lesions. steroid dose no > than maximum dose used in first 8 weeks of treatment.
Stable: Does not qualify for CR, PR, or progression steroid dose no > than maximum dose used in first 8 weeks of treatment.
Progression: 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no increase) Clear clinical worsening."|up to 3 years|"Arm1 had total of 7 pts with response however, 2 pts stopped treatment early and were censored at 6 and 10 weeks.
Arm 2 had total to 7 pts with response however 1 pt stopped treatment after 2 weeks but had a 4 week scan showing PR. - pt was censored."||weeks||95% Confidence Interval|Median
727706|NCT00369590|Primary|Safety Profile - Events That Discontinued Treatment|number of patients who experienced toxicity that led to being taken off treatment|Approximately 1 year (start of treatment - end of treatment)|||participants|||Number
727707|NCT00369590|Primary|Safety Profile - Toxicities|number of cycles patient was able to have before developing a toxicity that required removing the patient from treatment. Treatment: Aflibercept 4mg/kg intravenously on day 1 of every 14-day cycle - 2 week cycle.|Start to End of treatment 39 cycles or 1yr 7.5months (78 weeks)|||cycles||Full Range|Median
727708|NCT00369590|Secondary|Response Rate Associated With VEGF Trap Therapy Defined as Proportions of Patients Experiencing Complete or Partial Response|"pts had MRIs at screening and at the 3rd and 5th cycles then every 8 weeks until progression. All responders were centrally reviewed for confirmation
Response determined by modified MacDonald Criteria Complete Response (CR): Complete disappearance of all measurable and evaluable disease, no new lesions. no steroids Partial Response (PR): Greater than or equal to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable lesions. no new lesions. steroid dose no > than maximum dose used in first 8 weeks of treatment.
Stable: Does not qualify for CR, PR, or progression steroid dose no > than maximum dose used in first 8 weeks of treatment.
Progression: 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no increase) Clear clinical worsening."|Up to 2 years|The 3 pts in Arm 2 were treated at 2nd recurrence and were excluded from final efficacy analysis||participants|||Number
727709|NCT00369590|Primary|Progression-free Survival (PFS) at 6 Months|"This design yields 85% power to detect a true 30% 6-month PFS rate, while maintaining .91 probability of rejecting for a true 15% 6-month PFS rate.
pts had MRIs at screening and at the 3rd and 5th cycles then every 8 weeks until progression.
Response determined by modified MacDonald Criteria Complete Response (CR): Complete disappearance of all measurable and evaluable disease, no new lesions. no steroids Partial Response (PR): Greater than or equal to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable lesions. no new lesions. steroid dose no > than maximum dose used in first 8 weeks of treatment.
Stable: Does not qualify for CR, PR, or progression steroid dose no > than maximum dose used in first 8 weeks of treatment.
Progression: 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no increase) Clear clinical worsening."|6 months|"pts not known to be progression free at time of the 6-month scan (24weeks) were considered to experienced treatment failure. If at least 10pts (24%) are progression-frree at 6months (GBM) the agent will be considered promising for futher study.
The 3 pts in Arm 2 were treated at 2nd recurrence and were excluded from final efficacy analysis"||percentage of participants|||Number
727710|NCT00369655|Secondary|Number of Participant With Previous Treatment of Anti-HER2 With Cardiac Events||Up to 5 years|All participants who have received previous treatment with anti-HER2.||Participants|||Number
727711|NCT00369655|Secondary|Median Duration of Response|Duration of response was defined as for all evaluable patients who have achieved an objective response as the date at which the patient's objective status is first noted to be either a complete response or partial response to the date progression is documented.|Up to 5 years|Analysis population included only patients who have achieved a confirmed tumor response. The duration of response of 4.6 months is reported from one patient.||Months||95% Confidence Interval|Median
727712|NCT00369655|Secondary|Overall Survival|Overall survival time was defined as the number of months from registration to the date of death or last follow-up|Time from registration to death or last follow up (up to 5 years)|||Months||95% Confidence Interval|Median
727713|NCT00369655|Secondary|Progression Free Survival|Progression-free survival was defined as the number of months from registration to the date of disease progression or death, with patients who died without documentation of progression being considered to have progressed on the date of their death.|Time from registration to disease progression or death (up to 5 years)|||Months||95% Confidence Interval|Median
727714|NCT00369655|Primary|Proportion of Patients Receiving Vascular Endothelial Growth Factor (VEGF) Trap With 6-month Progression-free Survival|The 6-month progression free survival rate was defined as the proportion of efficacy-evaluable patients on study treatment and progression-free 6 months from registration. Patients who died without documentation of progression will be considered to have progressed on the date of their death.|6 months|All participants who have met the eligibility criteria, who have signed a consent form and have begun treatment were evaluable for response.||Participants|||Number
727715|NCT00369655|Primary|Proportion of Patients With Confirmed Tumor Response|Confirmed tumor response was defined as the total number of efficacy-evaluable patients who achieved a complete or partial response according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria on 2 consecutive evaluations at least 8 weeks apart.|Up to 5 years|All participants who have met the eligibility criteria, who have signed a consent form and have begun treatment were evaluable for response.||Participants|||Number
727716|NCT00369668|Primary|Fractionated Reaction Time|Premotor reaction times in milliseconds were recorded for the impaired arm of each participant in the three intervention (arm) groups. Premotor reaction time represents central processes. Lower times are faster reaction times, indicating less time to initiate a movement.|Baseline/pretest; posttest given between days 17-22 (posttest days 3-8)|All participants who completed the bilateral training protocols were submitted to statistical analysis. Premotor reaction data for all participants were collected twice: (a) baseline/pretest: before treatment and (b) posttest: after treatment.||milliseconds||Standard Error|Median
727717|NCT00369668|Primary|Fugl-Meyer Upper Extremity Motor Test|FM motor test assesses functional impairments post stroke as participants attempt various movements from daily activities. Minimum score = 0; maximum score = 66; lower scores indicate more impairments and higher scores indicate less impairments.|Baseline/pretest; posttest given between days 17-22 (posttest days 3 -8)|All participants who completed the bilateral training protocols were submitted to statistical analysis. Data for all participants were collected twice: (a) baseline/pretest: before treatment and (b) posttest: after treatment.||units on a scale||Standard Deviation|Mean
727718|NCT00369668|Primary|Box and Block Test; Data Collected = Number of Blocks Moved|"A 60 second timed hand/arm manipulation test in which participants reach, grasp, lift, and release a 1 x 1 block of wood. They must lift a block from one side of a box, carry it over a low barrier and release the block into the other side of the box."|Baseline/pretest; posttest given between days 17-22 (posttest days 3 -8)|All participants who completed the bilateral training protocols were submitted to statistical analysis. Data for all participants were collected twice: (a) baseline/pretest: before treatment and (b) posttest: after treatment.||Blocks||Standard Deviation|Mean
727719|NCT00369681|Secondary|Addition of Information to Fludeoxyglucose F 18 Positron Emission Tomography (FDG-PET) by Plasma DNA Biomarkers||5 years||||||
727720|NCT00369681|Secondary|Event-free Survival|Percentage of participants who did not experience death, relapse, or progression (worsening) of their lymphoma.|3 years|All evaluable participants.||percentage of participants||95% Confidence Interval|Number
727721|NCT00369681|Primary|Relationship Between Marker Detection and Clinical Outcome|Number of relapses for participants who did and did not have re-emergence of clonal CD27(+) ALDH(+) B cells after completing study intervention.|3 years|Only 21 participants had a detectable CD27(+) ALDH(+) clone prior to study intervention. The remaining participants either did not have such a clone or did not have a sample tested to look for a clone.||relapses|||Number
727722|NCT00369681|Primary|Impact of Rituximab on Plasma DNA Biomarkers||5 years||||||
727723|NCT00369746|Secondary|Timeline Follow Back (TLFB) Maximum Drinks Per Drinking Day|This variable reports maximum drinks per drinking day in a pre-defined time frame.|30 days|Subjects who met entering criteria for alcohol abuse or alcohol dependence per protocol||drinks||Standard Deviation|Mean
727724|NCT00369746|Secondary|Timeline Follow Back (TLFB) Drinking Days Per 30 Days|This variable reports drinking days in a pre-defined time frame.|30 days|Subjects who met entering criteria for alcohol abuse or alcohol dependence per protocol||days||Standard Deviation|Mean
727725|NCT00369746|Secondary|Quantitative Substance Use Inventory ((SUI)|"Quantitative Substance Use Inventory ((SUI) Measure substance use
Administered at either week 12 or 14: Any Illicit Drug Using in last 30 days"|30 days|All participants who met entry criteria for alcohol abuse or dependence per protocol.||Days||Standard Deviation|Mean
727726|NCT00369746|Secondary|Timeline Follow Back (TLFB) Average Drinks Per Drinking Day|This variable reports average drinks/drinking day in a pre-defined time frame.|30 days|Subjects who met entering criteria for alcohol abuse or alcohol dependence per protocol||drinks per drinking day||Standard Deviation|Mean
727727|NCT00369746|Primary|Quick Inventory of Depression- Self Report 16|"Quick Inventory of Depression- Self Report assesses 16 depressive symptoms experienced in the past week, based on self-rating, measured at study exit visit
Scale range:
Each of the four possible answers to each quiz is given an ascending numerical value from 0 to 3, and the total test score is the sum of the following: The highest number from questions 1-4 The number from question 5 The highest number from questions 6-9 The total of each question from 10-14 The highest number from questions 15-16
Total scoring ranges (0-48):
0-5, No Depression Likely 6-10, Possibly Mildly Depressed 11-15, Moderate Depression 16-20, Severe Depression 21 or Over, Very Severe Depression"|study exit visit, at Week 12|All participants who met entry criteria for alcohol abuse or dependence per protocol.||units on a scale||Standard Deviation|Mean
727728|NCT00369785|Primary|Memory as Quantified by the HVLT-discrimination|In the Hopkins Verbal Learning Test - discrimination, participants are given lists of 12 correct words and 12 incorrect words. HVLT-discrimination is the number of correctly recognized words minus the number incorrectly recognized. The range for this outcome measure is -12 to 12. Higher scores represent better memory.|24 weeks|Number of participants with 24 week memory data||units on a scale||Standard Error|Least Squares Mean
727729|NCT00369785|Primary|Memory as Quantified by HVLT-immediate Recall|Memory is quantified using the Hopkins Verbal Learning Test (HVLT) - immediate recall. Participants are asked to recall 12 words. Each recalled word is given one point. They are given three trials. The total score is the sum of the recalled words. The range for HVLT-Immediate recall is 0 to 36. Higher scores represent better memory.|24 weeks|Participants with 24 week HVLT data.||units on a scale||Standard Error|Least Squares Mean
727730|NCT00369824|Secondary|Number of Subjects Reporting Medically Significant Adverse Events (AEs)|Medically significant AEs assessed include AEs prompting emergency room or physician visits that are not related to common diseases or SAEs that are not related to common diseases.|During the active phase (up to Month 7 or Month 8) and throughout the entire study (up to Month 12 or Month 13)|||subjects|||Number
727731|NCT00369824|Secondary|Number of Subjects Reporting Unsolicited Adverse Events as New Onset Chronic Diseases (NOCDs)|NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes|During the active phase of the study (up to Month 7 or Month 8) and throughout the entire study period (up to Month 12 or Month 13)|||subjects|||Number
727732|NCT00369824|Secondary|Number of Subjects Reporting Serious Adverse Events|Serious adverse events assessed include medical occurrences that results in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the active phase of the study (up to Month 7 or Month 8) and throughout the entire study (up to Month 12 or Month 13)|||subjects|||Number
727733|NCT00369824|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited adverse event = Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any “solicited” symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.|During the 30-day period following each vaccination|||subjects|||Number
727734|NCT00369824|Secondary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed include Arthralgia, fatigue, fever, gastrointestinal, headache, myalgia, rash and urticaria|During the 7-day period following each vaccination|Analysis was performed on the Total Vaccinated cohort including all vaccinated subjects receiving one dose at least||subjects|||Number
727736|NCT00369824|Secondary|Number of Subjects With Anti-A, Anti-C, Anti-Y and Anti-W135 Vaccine Response|"Vaccine responses for anti-A, C, Y and W-135 defined as:
For initially seronegative subjects (pre-vaccination titer below cut-off of 8): antibody titers at least 4 times the cut-off (post vaccination titer ≥ 32)
For initially seropositive subjects (pre-vaccination titer above 8): antibody titers at least 4 times the pre-vaccination antibody titer"|One month after vaccination with Menactra|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity Month 1, and only for Cervarix + Menactra/Boostrix, Cervarix + Boostrix + Menactra and Menactra/Cervarix groups||subjects|||Number
727737|NCT00369824|Secondary|Number of Subjects With Booster Response for Anti-PT, Anti-FHA and Anti-PRN|"Booster responses defined as:
For initially seronegative subjects (pre-vaccination titer below cut-off: < 5 EL.U/mL): antibody titers at least 4 times the cut-off,
For initially seropositive subjects with pre-vaccination titer above 5 EL.U/mL and < 20 EL.U/mL: an increase in antibody titers of at least 4 times the pre-vaccination titer,
For initially seropositive subjects with pre-vaccination titer ≥ 20 EL.U/mL: an increase in antibody titers of at least two times the pre-vaccination titer"|One month after vaccination with Boostrix|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity Month 1, and only for Cervarix + Boostrix/Menactra, Cervarix + Boostrix + Menactra and Boostrix + Cervarix groups.||subjects|||Number
727738|NCT00369824|Secondary|Number of Subjects With Booster Response for Anti-D and Anti-T|"Booster responses for anti-D and anti-T defined as:
For initially seronegative subjects (pre-vaccination titer below cut-off: < 0.1 IU/mL): antibody titer at least 4 times the cut-off (post-vaccination titer ≥ 0.4 IU/mL)
For initially seropositive subjects (pre-vaccination titer above 0.1 IU/mL): an increase in antibody titer of at least 4 times the pre-vaccination titer"|One month after vaccination with Boostrix|Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity Month 1, and only for Cervarix + Boostrix/Menactra, Cervarix + Boostrix + Menactra and Boostrix/Cervarix groups.||subjects|||Number
727739|NCT00369824|Secondary|Concentration of Anti-D and Anti-T Antibodies|Concentrations given as Geometric Mean Concentrations (GMCs)|Before and one month after vaccination with Boostrix|Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity Month 1, and only for Cervarix + Boostrix/Menactra, Cervarix + Boostrix + Menactra and Boostrix/Cervarix groups.||International Unit per Milliliter||95% Confidence Interval|Geometric Mean
727740|NCT00369824|Secondary|Number of Subjects With Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibody Concentrations Above 0.1 International Unit Per Milliliter (IU/mL)|Anti-D and anti-T antibodies cut-off values assessed include 0.1 international unit per milliliter (IU/mL)|Before and one month after vaccination with Boostrix|Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity Month 1, and only for Cervarix + Boostrix/Menactra, Cervarix + Boostrix + Menactra and Boostrix/Cervarix groups||subjects|||Number
727741|NCT00369824|Secondary|Number of Subjects With Anti-human Papilloma Virus 16 (Anti-HPV16) and Anti-human Papilloma Virus 18 (Anti-HPV18) Antibody Concentrations Above Pre-defined Cut-off Values|Cut-off values assessed include 8 enzyme-linked immunosorbent assay units Per Milliliter (EL.U/mL) for anti-HPV16 antibodies and 7 EL.U/mL for anti-HPV18 antibodies.|Before vaccination (PRE), one month post Dose 2 (Mth2) and one and six months post Dose 3 (Mth 7 and Mth 12)|Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity at Month 12/13||subjects|||Number
727742|NCT00369824|Primary|Titer of Meningococcal Serogroup A (Anti-A), Meningococcal Serogroup C (Anti-C), Meningococcal Serogroup Y (Anti-Y) and Meningococcal Serogroup W-135 (Anti-W135) Antibodies|Titers given as Geometric Mean Titers (GMTs)|Before and one month after vaccination with Menactra|Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity Month1 and only for Cervarix + Menactra/Boostrix, Cervarix + Boostrix + Menactra and Menactra/Cervarix groups.||Titer||95% Confidence Interval|Geometric Mean
727743|NCT00369824|Primary|Concentration of Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibodies|Concentrations given as Geometric Means Concentrations (GMCs)|Before and one month after vaccination with Boostrix|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity Month 1, and only for Cervarix + Boostrix/Menactra, Cervarix + Boostrix + Menactra and Boostrix/Cervarix groups.||International Units per Milliliter||95% Confidence Interval|Geometric Mean
727744|NCT00369824|Primary|Number of Subjects With Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibody Concentrations Above 1.0 International Unit Per Milliliter (IU/mL)|Anti-D and anti-T antibodies cut-off values assessed include 1.0 international unit per milliliter (IU/mL)|Before and one month after vaccination with Boostrix|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, Month 1 and only for Cervarix + Boostrix/Menactra, Cervarix + Boostrix + Menactra and Boostrix/Cervarix groups.||subjects|||Number
727745|NCT00369915|Secondary|Hamilton Anxiety Rating Scale|The Hamilton Anxiety Rating Scale (HARS) has a range of scores from 0 to 56 where the highest values indicate the most anxiety.|Each of 12 sessions.|Only study completers were analyzed.||units on a scale||Standard Deviation|Mean
727746|NCT00369915|Primary|Change in Depression Severity|The Montgomery-Asberg Depression Rating Scale (MADRS) has a range of scores from 0 to 60 where the highest values indicate the most depression.|Outcome measures obtained at each of 12 sessions|Only participants who completed the trial were included in the analysis.||units on a scale||Standard Deviation|Mean
727747|NCT00369928|Primary|Proportion of Patients Meeting American College of Rheumatology 20 Response Criteria (ACR20) at 12weeks|percent, relative to baseline, of patients meeting the American College of Rheumatology 20 response criteria (ACR20) at 12weeks|12 weeks|||percent meeting ACR 20||95% Confidence Interval|Number
727748|NCT00369941|Secondary|Number of Participants Discontinued With Drug-related LAEs at Week 240|"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.
Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|240 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.||Participants|||Number
728584|NCT00368316|Secondary|Percentage of Efficacy|Percent efficacy is defined as ((disease rate of controls minus disease rate of vaccinees) divided by disease rate of controls) times 100|During 2 years post vaccination|||Percent efficacy||95% Confidence Interval|Mean
727749|NCT00369941|Secondary|Number of Participants Discontinued With Drug-related LAEs at Week 156|"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.
Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|156 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.||Participants|||Number
727750|NCT00369941|Secondary|Number of Participants Discontinued With Drug-related LAEs at Week 96|"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.
Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|96 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.||Participants|||Number
727751|NCT00369941|Secondary|Number of Participants Discontinued With LAEs at Week 240|A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.|240 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.||Participants|||Number
727752|NCT00369941|Secondary|Number of Participants Discontinued With LAEs at Week 156|A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.|156 Weeks|All patients who took study medication and had any laboratory tests performed were included in the analysis.||Participants|||Number
727753|NCT00369941|Secondary|Number of Participants Discontinued With LAEs at Week 96|A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.|96 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.||Participants|||Number
727754|NCT00369941|Secondary|Number of Participants With Serious Drug-related LAEs at Week 240|"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.
Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.
Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|240 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.||Participants|||Number
727755|NCT00369941|Secondary|Number of Participants With Serious Drug-related LAEs at Week 156|"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.
Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.
Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|156 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.||Participants|||Number
727756|NCT00369941|Secondary|Number of Participants With Serious Drug-related LAEs at Week 96|"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.
Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.
Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|96 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.||Participants|||Number
727757|NCT00369941|Secondary|Number of Participants With Serious LAEs at Week 240|"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.
Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose."|240 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.||Participants|||Number
727758|NCT00369941|Secondary|Number of Participants With Serious LAEs at Week 156|"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.
Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose."|156 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.||Participants|||Number
727759|NCT00369941|Secondary|Number of Participants With Serious LAEs at Week 96|"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.
Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose."|96 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.||Participants|||Number
727760|NCT00369941|Secondary|Number of Participants With Drug-related LAEs at Week 240|"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.
Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|240 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.||Participants|||Number
727761|NCT00369941|Secondary|Number of Participants With Drug-related LAEs at Week 156|"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.
Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|156 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.||Participants|||Number
727762|NCT00369941|Secondary|Number of Participants With Drug-related LAEs at Week 96|"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.
Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|96 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.||Participants|||Number
727763|NCT00369941|Secondary|Number of Participants With LAEs at Week 240|A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.|240 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.||Participants|||Number
727764|NCT00369941|Secondary|Number of Participants With LAEs at Week 156|A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.|156 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.||Participants|||Number
727765|NCT00369941|Secondary|Number of Participants With LAEs at Week 96|A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.|96 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.||Participants|||Number
727766|NCT00369941|Secondary|Number of Participants That Discontinued With Serious Drug-related CAEs at Week 240|"Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.
Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|240 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
727767|NCT00369941|Secondary|Number of Participants That Discontinued With Serious Drug-related CAEs at Week 156|"Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.
Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|156 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
727768|NCT00369941|Secondary|Number of Participants That Discontinued With Serious Drug-related CAEs at Week 96|"Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.
Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|96 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
727769|NCT00369941|Secondary|Number of Participants That Discontinued With Serious CAEs at Week 240|Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.|240 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
728064|NCT00371826|Secondary|Number of Participants With Antibody-mediated Rejection Per Treatment Group (12 Months Analysis)||At Month 12|Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication.||Participants|||Number
727770|NCT00369941|Secondary|Number of Participants That Discontinued With Serious CAEs at Week 156|Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.|156 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
727771|NCT00369941|Secondary|Number of Participants That Discontinued With Serious CAEs at Week 96|Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.|96 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
727772|NCT00369941|Secondary|Number of Participants That Discontinued With Drug-related CAEs at Week 240|"Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|240 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
727773|NCT00369941|Secondary|Number of Participants That Discontinued With Drug-related CAEs at Week 156|"Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|156 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
727774|NCT00369941|Secondary|Number of Participants That Discontinued With Drug-related CAEs at Week 96|"Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|96 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
727775|NCT00369941|Secondary|Number of Participants That Discontinued With CAEs at Week 240|An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.|240 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
727776|NCT00369941|Secondary|Number of Participants That Discontinued With CAEs at Week 156|An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.|156 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
727777|NCT00369941|Secondary|Number of Participants That Discontinued With CAEs at Week 96|An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.|96 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
727778|NCT00369941|Secondary|Number of Participants That Died by Week 240|All participant deaths in the span of 240 weeks on study were recorded.|240 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
727779|NCT00369941|Secondary|Number of Participants That Died by Week 156|All participant deaths in the span of 156 weeks on study were recorded.|156 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
727780|NCT00369941|Secondary|Number of Participants That Died by Week 96|All participant deaths in the span of 96 weeks on study were recorded.|96 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
727781|NCT00369941|Secondary|Number of Participants With Serious Drug-related CAEs at Week 240|"Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.
Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|240 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
727782|NCT00369941|Secondary|Number of Participants With Serious Drug-related CAEs at Week 156|"Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.
Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|156 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
727783|NCT00369941|Secondary|Number of Participants With Serious Drug-related CAEs at Week 96|"Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.
Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|96 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
727784|NCT00369941|Secondary|Number of Participants With Drug-related CAEs at Week 240|"Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|240 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
727785|NCT00369941|Secondary|Number of Participants With Drug-related CAEs at Week 156|"Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|156 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
727786|NCT00369941|Primary|Number of Participants Discontinued With Drug-related LAEs at Week 48|"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.
Adverse events (AEs) in this study were defined as drug-related if the investigator considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone."|48 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.||Participants|||Number
727787|NCT00369941|Primary|Number of Participants Discontinued With LAEs at Week 48|A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.|48 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.||Participants|||Number
727788|NCT00369941|Primary|Number of Participants With Serious Drug-related LAEs at Week 48|"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.
Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.
Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|48 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.||Participants|||Number
727789|NCT00369941|Primary|Number of Participants With Drug-related LAEs at Week 48|"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.
Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|48 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.||Participants|||Number
727790|NCT00369941|Primary|Number of Participants With Serious LAEs at Week 48|"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.
Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose."|48 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.||Participants|||Number
727791|NCT00369941|Primary|Number of Participants With Laboratory Adverse Experiences (LAEs) at Week 48|A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.|48 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.||Participants|||Number
727792|NCT00369941|Primary|Number of Participants That Discontinued With Serious Drug-related CAEs at Week 48|"Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.
Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|48 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
727793|NCT00369941|Primary|Number of Participants That Discontinued With Drug-related CAEs at Week 48|"Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|48 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
727794|NCT00369941|Primary|Number of Participants That Discontinued With Serious CAEs at Week 48|Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.|48 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
727795|NCT00369941|Primary|Number of Participants That Discontinued With CAEs at Week 48|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.|48 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
727796|NCT00369941|Primary|Number of Participants That Died by Week 48|All participant deaths in the span of 48 weeks on study were recorded.|48 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
727812|NCT00369941|Secondary|Change From Baseline in CD4 Cell Count at Week 156|Mean change from baseline at Week 156 in CD4 cell count (cells/mm3)|Baseline and Week 156|Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 cell count (cells/mm3) was carried forward for participants who discontinued assigned therapy due to lack of efficacy.||CD4 Cell Count (cells/mm3)||95% Confidence Interval|Mean
727797|NCT00369941|Primary|Number of Participants With Serious Drug-related CAEs at Week 48|"Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.
Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|48 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
727798|NCT00369941|Primary|Number of Participants With Drug-related CAEs at Week 48|"Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|48 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
727799|NCT00369941|Primary|Number of Participants With Serious CAEs at Week 48|Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.|48 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
727800|NCT00369941|Primary|Number of Participants With Clinical Adverse Experiences (CAEs) at Week 48|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.|48 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
727801|NCT00369941|Secondary|Number of Participants With Drug-related CAEs at Week 96|"Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|96 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
727802|NCT00369941|Secondary|Number of Participants With Serious CAEs at Week 240|Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.|240 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
727803|NCT00369941|Secondary|Number of Participants With Serious CAEs at Week 156|Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.|156 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
727804|NCT00369941|Secondary|Number of Participants With Serious CAEs at Week 96|Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.|96 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
727805|NCT00369941|Secondary|Number of Participants With CAEs at Week 240|An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.|240 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
727806|NCT00369941|Secondary|Number of Participants With CAEs at Week 156|An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.|156 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
727807|NCT00369941|Secondary|Number of Participants With CAEs at Week 96|An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.|96 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
727808|NCT00369941|Secondary|Number of Participants With Nervous System Symptoms Assessed by Review of Accumulated Safety Data up to Week 8|Participants with dizziness, insomnia, somnolence, concentration impaired, depression, nightmare, confusional state, suicidal ideation, nervous system disorder, psychotic disorder, abnormal dreams, suicide attempt, acute psychosis, delirium, depressed level of consciousness, hallucination, auditory hallucination, completed suicide, and major depression|8 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
727809|NCT00369941|Secondary|Change From Baseline in CD4 Cell Count at Week 240|Mean change from baseline at Week 240 in CD4 cell count (cells/mm3)|Baseline and Week 240|Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 cell count (cells/mm3) was carried forward for participants who discontinued assigned therapy due to lack of efficacy.||CD4 Cell Count (cells/mm3)||95% Confidence Interval|Mean
727810|NCT00369941|Secondary|Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 240|Antiretroviral activity was evaluated for participants who achieved HIV RNA level <400 copies/mL at Week 240.|240 Weeks|All participants who took study medication and had HIV RNA tests performed were included in the analysis.||Participants|||Number
727811|NCT00369941|Secondary|Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 240|Antiretroviral activity was evaluated for participants who achieved HIV RNA level <50 copies/mL at Week 240.|240 Weeks|All participants who took study medication and had HIV RNA tests performed were included in the analysis.||Participants|||Number
727813|NCT00369941|Secondary|Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 156|Antiretroviral activity was evaluated for participants who achieved HIV RNA level <400 copies/mL at Week 156.|156 Weeks|All participants who took study medication and had HIV RNA tests performed were included in the analysis.||Participants|||Number
727815|NCT00369941|Secondary|Change From Baseline in CD4 Cell Count at Week 96|Mean change from baseline at Week 96 in CD4 cell count (cells/mm3)|Baseline and Week 96|Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 cell count (cells/mm3) was carried forward for participants who discontinued assigned therapy due to lack of efficacy.||CD4 Cell Count (cells/mm3)||95% Confidence Interval|Mean
727816|NCT00369941|Secondary|Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 96|Antiretroviral activity was evaluated for participants who achieved HIV RNA level <400 copies/mL at Week 96.|96 Weeks|All participants who took study medication and had HIV RNA tests performed were included in the analysis.||Participants|||Number
727817|NCT00369941|Secondary|Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 96|Antiretroviral activity was evaluated for participants who achieved HIV RNA level <50 copies/mL at Week 96.|96 Weeks|All participants who took study medication and had HIV RNA tests performed were included in the analysis.||Participants|||Number
727818|NCT00369941|Secondary|Change From Baseline in Cluster of Differentiation Antigen 4 (CD4) Cell Count at Week 48|Mean change from baseline at Week 48 in CD4 cell count (cells/mm3)|Baseline and Week 48|Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 cell count (cells/mm3) was carried forward for participants who discontinued assigned therapy due to lack of efficacy.||CD4 Cell Count (cells/mm3)||95% Confidence Interval|Mean
727819|NCT00369941|Secondary|Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 48|Antiretroviral activity was evaluated for participants who achieved HIV RNA level <400 copies/mL at Week 48.|48 Weeks|All participants who took study medication and had HIV RNA tests performed were included in this analysis.||Participants|||Number
727820|NCT00369941|Primary|Number of Participants Who Achieved Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) <50 Copies/mL at Week 48|Antiretroviral activity was evaluated for participants who achieved HIV RNA level <50 copies/mL at Week 48.|48 Weeks|All participants who took study medication and had HIV RNA tests performed were included in the analysis.||Participants|||Number
727821|NCT00369967|Secondary|Patient Satisfaction|Rating of patient satisfaction with method|3, 6, and 12 months|None of the participants returned their satisfaction survey|||||
727822|NCT00369967|Secondary|Bleeding Profile||3, 6, and 12 months|None of the participants returned their menstrual calendars to assess this outcome|||||
727823|NCT00369967|Secondary|Pregnancy|Number of pregnancies reported|3,6, and 12 mo|There were no reported pregnancies during the study period||participants|||Number
727824|NCT00369967|Primary|Method Continuation at 12 Months|Participants reporting continuation with method at 12 months|12 months|Participants enrolled||participants|||Number
727825|NCT00369967|Primary|Method Continuation at 6 Months|Participants reporting continuation of method at 6 months|6 months|Participants enrolled||participants|||Number
727826|NCT00369967|Primary|Continuation With the Contraceptive Method|Participants reporting continuation with contraceptive method at 3 months|3 months|Number using method at 3 months||participants|||Number
727827|NCT00370032|Secondary|Left Colon and Rectal Mucosal Blood Flow Cohort Comparisons|On Day 6 of each treatment period approximately 1 hour after dosing, subjects underwent a flexible sigmoidoscopy with Laser Doppler Flowmetry (LDF) to measure Mucosal Blood Flow (MBF). There was no pre-treatment LDF procedure, MBF was compared between the Healthy and d-IBS cohorts using the flow rates from the placebo treatment period.|Day 6 after each treatment period|Population: modified per protocol to include placebo information only.||ml per minute per 100 grams of tissue||Standard Deviation|Mean
727828|NCT00370032|Secondary|Rectal Mucosal Blood Flow (MBF)|On Day 6 of each treatment period approximately 1 hour after dosing, subjects underwent a flexible sigmoidoscopy with Laser Doppler Flowmetry (LDF) to measure Mucosal Blood Flow (MBF). There was no pre-treatment LDF procedure, MBF was compared between the Healthy and d-IBS cohorts using the flow rates from the placebo treatment period.|Day 6 after each treatment period|||ml per minute per 100 grams of tissue||Standard Deviation|Mean
727829|NCT00370032|Primary|Left Colon Mucosal Blood Flow (MBF)|On Day 6 of each treatment period; 1 hour after dosing, subjects underwent a flexible sigmoidoscopy with Laser Doppler Flowmetry (LDF) to measure Mucosal Blood Flow (MBF). There were no pre-treatment LDF procedure, MBF was compared between the Healthy volunteers and D-irritable bowel syndrome (IBS) cohorts using the flow rates from the placebo treatment period.|Day 6 after each treatment period|Per Protocol Population - the population used for the primary and secondary outcome analyses. The population consisted of all randomized subjects who completed the study with MBF measurements for both treatment periods.||ml per minute per 100 grams of tissue||Standard Deviation|Mean
727830|NCT00370071|Secondary|Percentage of Subjects Without EDSS Progression|The EDSS is a scale based on the standardized neurological examination which comprised of optic, brain stem/cranial nerves, pyramidal, cerebellar, sensory, vegetative, and cerebral functions, as well as walking ability.The EDSS scores range from 0.0 (normal) to 10.0 (dead). A score of 2 to 3 indicates minimal to moderate disability. An EDSS progression was defined as increase in EDSS greater than or equal to (>=) 1.0 points (in the treatment period as compared to baseline).|Baseline up to Week 24|FAS||percentage of subjects|||Number
727831|NCT00370071|Secondary|Expanded Disability Status Scale (EDSS)|The EDSS is a scale based on the standardized neurological examination which comprised of optic, brain stem/cranial nerves, pyramidal, cerebellar, sensory, vegetative, and cerebral functions, as well as walking ability. The EDSS scores range from 0.0 (normal) to 10.0 (dead). A score of 2 to 3 indicates minimal to moderate disability.|Pre-treatment on Day 1, Week 24|FAS subjects with EDSS assessments at the end of the study (Week 24)||Scores on a scale||Standard Deviation|Mean
727832|NCT00370071|Secondary|Assessment of Relapses: Relapse Severity|A relapse was defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical event. The abnormality must be present for at least 24 hours and occur in the absence of fever (axillary temperature >37.5 degree celsius / 99.5 degree fahrenheit) or known infection. A relapse must be confirmed by a documented report from a physician or by objective assessment. A major relapse was defined based on changes on EDSS with the following additional criteria to be met: objective neurological impairment, correlating with the subject’s reported symptoms, defined as either increase in at least one of the functional systems of the EDSS score or increase of the total EDSS score. Relapses which did not meet the criteria of major relapses were considered as non-major.|Baseline up to Week 24|FAS with all subjects who had reported relapses||relapses|||Number
727833|NCT00370071|Secondary|Assessment of Relapses: Percentage of Relapse-free Subjects After 24 Weeks|A relapse was defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical event. The abnormality must be present for at least 24 hours and occur in the absence of fever (axillary temperature >37.5 degree celsius / 99.5 degree fahrenheit) or known infection. A relapse must be confirmed by a documented report from a physician or by objective assessment.|After 24 weeks|FAS||percentage of subjects|||Number
727834|NCT00370071|Secondary|Assessment of Relapses: Number of Relapses|A relapse was defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical event. The abnormality must be present for at least 24 hours and occur in the absence of fever (axillary temperature >37.5 degree celsius / 99.5 degree fahrenheit) or known infection. A relapse must be confirmed by a documented report from a physician or by objective assessment. In the categories listed below, “N” signifies the number of subjects evaluable for the timepoints, and same subjects were counted more than once under each category.|3 and 6 months|FAS with all subjects who had reported relapses||relapses|||Number
727835|NCT00370071|Secondary|Assessment of Relapses: Relapse Rate|A relapse was defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical event. The abnormality must be present for at least 24 hours and occur in the absence of fever (axillary temperature more than (>) 37.5 degree celsius / 99.5 degree fahrenheit) or known infection. A relapse must be confirmed by a documented report from a physician or by objective assessment. The relapse rate was calculated on an annualized basis. Annualized relapse rate is the average number of relapses in a year calculated by negative binomial regression as the sum of confirmed relapses of all subjects in the group divided by the sum of the number of days on study of all subjects in the group and multiplied by 365.25.|Baseline up to Week 24|Full analysis set (FAS)||relapses per year|||Number
727836|NCT00370071|Secondary|Number of T2 Lesions at Baseline, Weeks 12 and 24|In the categories listed below, “N” signifies the number of subjects evaluable for the timepoints.|Baseline, Weeks 12 and 24|MRS||Lesions||Standard Deviation|Mean
727837|NCT00370071|Secondary|Number of New Gadolinium (T1)-Enhancing Lesions at Baseline, Weeks 12 and 24|In the categories listed below, “N” signifies the number of subjects evaluable for the timepoints.|Baseline, Weeks 12 and 24|MRS||Lesions||Standard Deviation|Mean
727838|NCT00370071|Secondary|Volume of Gadolinium-enhancing Lesions at Baseline, Weeks 12 and 24|In the categories listed below, “N” signifies the number of subjects evaluable for the timepoints.|Baseline, Weeks 12 and 24|MRS||cubic millimeter (mm^3)||Standard Deviation|Mean
727839|NCT00370071|Secondary|Difference Between the Number of New or Enlarging T2 Lesions Per 3 Months During the 6-month Treatment Period and the Number of New or Enlarging T2 Lesions During 3-month Pre-treatment|This secondary endpoint (component of the primary endpoint) was calculated by subtracting the number of new or enlarging T2 lesions during the 3-month pre-treatment period from the cumulative number of new or enlarging T2 lesions during the 6-month treatment period divided by 2 (number of new T2 lesions per three months) based on non-enhancing lesions on T1 weighted scans|after 6 months of treatment as compared to the 3-month pre-treatment|The primary analysis set included all MRS (MRI set) patients who had at least one dose of study drug and at least one evaluable post-baseline MRI scan. The primary endpoint data was missing for one patient.||lesions||Full Range|Median
727840|NCT00370071|Secondary|Difference Between the Number of New Gadolinium (Gd)-Enhancing Lesions Per 3 Months During the 6-month Treatment Period and the Number of New Gd-enhancing Lesions During 3-month Pre-treatment|This secondary endpoint (component of the primary endpoint) was calculated by subtracting the number of new Gd-enhancing lesions during the 3-month pre-treatment period from the cumulative number of new Gd-enhancing lesions during the 6-month treatment period divided by 2 (number of new Gd-enhancing lesions per three months)|after 6 months of treatment as compared to 3-month pre-treatment|The primary analysis set included all MRS (MRI set) patients who had at least one dose of study drug and at least one evaluable post-baseline MRI scan. The primary endpoint data was missing for one patient.||lesions||Full Range|Median
727841|NCT00370071|Primary|Difference Between the Number of Newly Active Lesions in Magnetic Resonance Imaging (MRI) Per Three Months During the 6-month Treatment Period and the Number of Newly Active Lesions During 3-month Pre-treatment|The primary efficacy variable was calculated by subtracting the number of newly active lesions during the 3-month pre-treatment period from the cumulative number of newly active lesions during the 6-month treatment period divided by 2 (number of newly active lesions per three months, new lesion frequency per 3 months)|after 6 months of treatment as compared to 3-month pre-treatment|The primary analysis set included all MRS (MRI set) patients who had at least one dose of study drug and at least one evaluable post-baseline MRI scan. The primary endpoint data was missing for one patient.||lesions||Full Range|Median
727842|NCT00370149|Secondary|Death|Patient Death during hospitalization.|Participants were followed for the duration of the hospital stay, an average of 6 days.|The intention-to-treat population consisted of all randomized participants with valid informed consent. Participants were analyzed according to treatment assigned at randomization.||participants|||Number
727843|NCT00370149|Secondary|Episodes of Clinical Sepsis and/or Infection With Identified Source Other Than Catheter|A secondary outcome measure was episodes of clinical sepsis and/or infection with identified source other than the CVC.|Participants were followed for the duration of hospital stay, an average of 6 days.|The intention-to-treat population consisted of all randomized participants with valid informed consent. Participants were analyzed according to treatment assigned at randomization.||participants|||Number
727844|NCT00370149|Primary|Incidence of Catheter-related Bloodstream Infections (CRBSI) Per 1000 Catheter Days|Rates of CRBSI defined as 1. micro-organism isolated from a blood culture; 2. Clinical manifestations of infection such as fever (≥38 C) and/or hypotension (defined according to age-related practice guidelines for systolic blood pressure); 3. No apparent source for the bloodstream infection except for the catheter.|Participants were followed for the duration of the hospital stay, an average of 6 days.|The intention-to-treat population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.||participants|||Number
727845|NCT00370292|Primary|Mean Human Equilibrative Nucleoside Transporter 1 (hENT) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3|dCK (see Outcome #1)and hENT expression (see Outcome #2) on normal lymphocytes were measured after Pemetrexed administration to evaluate if there was reproducible timing of maximum dCK expression, and to assess proper time interval between pemetrexed and gemcitabine for treatment of patients with advanced Non-Small Cell Lung Cancer (NSCLC). Values are calculated as ratio between thereshold cycles (number of polymerase chain reaction [PCR] cycles) with respect to a reference gene; in this case glyceraldehyde 3-phosphate dehydrogenase (GAPDH).|pre-dose, 1, 2, 4, 6, 24, and 48 hours post-dose (3 cycles)|Number of participants who received at least one dose of study drug.||mRNA relative values (ratio with GAPDH)||Standard Deviation|Mean
727846|NCT00370292|Secondary|Best Objective Tumor Response|Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.|baseline to measured response (every 14 days for 6 cycles)|Number of participants who received at least one dose of study drug.||participants|||Number
727847|NCT00370292|Primary|Mean Deoxycytidine Kinase (dCK) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3|dCK and hENT expression (see Outcome #2) on normal lymphocytes were measured after Pemetrexed administration to evaluate if there was reproducible timing of maximum dCK expression, and to assess proper time interval between pemetrexed and gemcitabine for treatment of patients with advanced Non-Small Cell Lung Cancer (NSCLC). Values are calculated as ratio between thereshold cycles (number of polymerase chain reaction [PCR] cycles) with respect to a reference gene; in this case glyceraldehyde 3-phosphate dehydrogenase (GAPDH).|pre-dose, 1, 2, 4, 6, 24, and 48 hours post-dose (3 cycles)|All participants who received at least one dose of study drug.||mRNA relative values (ratio with GAPDH)||Standard Deviation|Mean
727848|NCT00370331|Secondary|HR-QoL Instrument and Domain Scores From the MEI-SF Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment|Health-related quality of life (HR-QoL) patient reported outcomes from the motivation and energy inventory-short form (MEI-SF) questionnaire. Scores could range from 0 (worst possible) to 72 (best possible).|Baseline, Week 6, Week 14, and Week 26/Early Withdrawal|ITT Population||Points on a scale (0-72)||Standard Deviation|Mean
727849|NCT00370331|Secondary|HR-QoL Instrument and Domain Scores for the FACT-Th Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment|Health-related quality of life (HR-QoL) patient reported outcomes from the functional assessment of cancer therapy thrombocytopenia (FACT-Th) questionnaire (six selected items). Scores could range from 0 (worst possible) to 24 (best possible).|Baseline, Week 6, Week 14, and Week 26/Early Withdrawal|ITT Population||Points on a scale (0-24)||Standard Deviation|Mean
727850|NCT00370331|Secondary|HR-QoL Instrument and Domain Scores From the FACIT-F Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment|Health-related quality of life (HR-QoL) patient reported outcomes from the functional assessment of chronic illness therapy fatigue (FACIT-F) questionnaire. Scores could range from 0 (worst possible) to 52 (best possible).|Baseline, Week 6, Week 14, and Week 26/Early Withdrawal|ITT Population||Points on a scale (0-52)||Standard Deviation|Mean
727851|NCT00370331|Secondary|HR-QoL Instrument and Domain Scores From the SF-36v2 Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment|Health-related quality of life (HR-QoL) patient reported outcomes from the short form-36v2 (SF-36v2) questionnaire. Scores could range from 0 (worst possible) to 100 (best possible).|Baseline, Week 6, Week 14, and Week 26/Early Withdrawal|ITT Population||Points on a scale (0-100)||Standard Deviation|Mean
727852|NCT00370331|Secondary|WHO Bleeding Scale|Summary of World Health Organization (WHO) bleeding scores at each nominal visit. WHO Grades 1-4 = any bleeding; WHO Grades 2-4 = clinically significant bleeding|Baseline, all nominal visits on-therapy defined as Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Week 10, Week 14, Week 18, Week 22, Week 26, and 1, 2 and 4 week follow-up visits|ITT Population||Percentage of participants|||Number
727853|NCT00370331|Secondary|Percentage of Participants With a Reduction in Use of Baseline ITP Medication|Percentage of participants who experienced a reduction in their baseline concomitant ITP medication use|From Day 1 through Week 26 on-treatment|ITT Population||Percentage of participants|||Number
727854|NCT00370331|Secondary|Maximum and Total Weeks of Platelet Response|Response is defined as a platelet count between 50,000 and 400,000 platelets per microliter.|Day 1 through Week 26 on-treatment|ITT Population||Weeks||Full Range|Median
727855|NCT00370331|Secondary|Percentage of Participants Initiating Rescue Treatment On-therapy|Percentage of participants initiating new ITP medication, an increased dose of concomitant ITP medication from baseline, platelet transfusion, or splenectomy.|Anytime from Day 1 to Week 26|All participants randomized to receive placebo or eltrombopag treatment||Percentage of participants|||Number
727856|NCT00370331|Secondary|Summary of Median Platelet Counts|Platelet counts were measured by blood draw.|Baseline; Day 8 through Week 26 on-treatment; and 1, 2, 4 week follow-up visits|ITT Population||platelets/microliter (ul)||Full Range|Median
727857|NCT00370331|Primary|Percentage of Responders|The percentage of evaluable participants who achieved a platelet response (defined as a platelet count between 50,000 and 400,000 microliter) at each nominal on-therapy day and 4 weeks post-treatment|Baseline; each on-therapy treatment day; Weeks 10, 14, 18, 22, and 26; and Weeks 1, 2, and 4 post-treatment|Intent-to-Treat (ITT) Population: all randomized participants||Percentage of participants|||Number
727858|NCT00370552|Secondary|Number of Participants With Abnormalities in Renal Function by Worst CTC Grade|Creatine Gr 1: >ULN to 1.5*ULN, Gr 2: 1.5 to 3.0*ULN, Gr 3: >3.0 to 6.0*ULN, Gr 4: >6.0*ULN.|At initiation of treatment and throughout study, to a minimum of 30 days after last dose of study drug. Laboratory tests performed within 72 hours before start of each cycle|All randomized participants who received any study drug and had samples available.||Participants|||Number
727871|NCT00370682|Secondary|Percentage of Subjects With Neutralizing Antibodies to Each DEN Type, After Each Dose of Study Vaccines|"Percentage of subject with Tetravalent responses for neutralizing antibodies, according to pre-vaccination dengue immune status. There was no placebo run for DEN Monovalent.
PRE = Pre-vaccination PI(M1) = Post Dose 1, Month 1 PII(M7) = Post Dose 2, Month 7"|post dose 1 and 2|||% of subjects||95% Confidence Interval|Number
727859|NCT00370552|Secondary|Number of Participants With Abnormalities in Liver Function by Worst CTC Grade|ULN=Upper limit of normal.ALT Gr 1:>ULN to 2.5*ULN, Gr 2: >2.5 to 5.0*ULN, Gr 3: >5.0 to 20.0*ULN, Gr 4: >20.0*ULN; AST Gr 1: >ULN to 2.5*ULN, Gr 2: >2.5 to 5.0*ULN, Gr 3: >5.0 to 20.0*ULN, Gr 4: >20.0*ULN; ALP Gr 1:>ULN to 2.5*ULN, Gr 2: >2.5 to 5.0*ULN, Gr 3: >5.0 to 20.0*ULN, Gr 4: >20.0*ULN; Total bilirubin Gr 1: >ULN to 1.5*ULN, Gr 2: >1.5 to 3.0*ULN, Gr 3: >3.0 to 10.0*ULN, Gr 4: >10.0*ULN.|At initiation of treatment and throughout study, to a minimum of 30 days after last dose of study drug. Laboratory tests performed within 72 hours before start of each cycle|All randomized participants who received any study drug and had samples available.||Participants|||Number
727860|NCT00370552|Secondary|Number of Participants With Abnormalities in Hematology Laboratory Results by Worst Common Terminology Criteria (CTC) Grade|CTC, Version 3 used to assess parameters. CTC Gr=Grade; WBC=white blood cells; ANC=absolute neutrophil count. LLN=lower level of normal. WBC Gr 1:<LLN to 3.0*10^9/L, Gr 2:<3.0 to 2.0*10^9/L, Gr 3:<2.0 to 1.0*10^9/L, Gr 4:<1.0*10^9/L; ANC Gr 1:<LLN to 1.5*10^9/L, Gr 2:<1.5 to 1.0*10^9/L, Gr 3:<1.0 to 0.5*10^9/L, Gr 4:<0.5*10^9/L; Platelet count Gr 1:LLN to 75.0*10^9/L, Gr 2:<75.0 to 50.0*10^9/L, Gr 3:<50.0 to 25.0*10^9/L, Gr 4:<25.0 to 10^9/L; Hemoglobin Gr 1:<LLN to 10.0 g/dL, Gr 2:<10.0 to 8.0 g/dL, Gr 3:<8.0 to 6.5 g/dL, Gr 4:<6.5 g/dL.|At initiation of treatment and throughout study, to a minimum of 30 days after last dose of study drug. Laboratory tests performed within 72 hours before start of each cycle|All randomized participants who received any study drug.||Participants|||Number
727861|NCT00370552|Primary|Number of Participants With Best Response As Assessed With Response Evaluation Criteria in Solid Tumors (RECIST)|Best tumor response was assessed with RECIST. Complete response (CR)=Disappearance of all evidence of target lesions; Partial response (PR)=At least 30% reduction from baseline in the sum of the longest diameter (LD) of all target lesions; Progressive disease (PD)=At least a 20% increase from baseline in the sum of LD of target lesions or the appearance of 1 or more new lesions; Stable disease (SD)=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. A response was confirmed if noted on 2 examinations at least 4 weeks apart.|Baseline visit and then every 8 weeks to 12 months, then every 3 months until disease progression|All randomized participants||Participants|||Number
727862|NCT00370552|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs) Treatment-related SAEs, Treatment-related Adverse Events (AEs) Leading to Discontinuation, AEs Leading to Discontinuation, Treatment-related AEs|An AE is any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, drug dependency or abuse; is life-threatening, an important medical event, a congenital anomaly/birth defect; requires inpatient hospitalization; or prolongs existing hospitalization. Treatment related=possibly, probably, or certainly related to and of unknown relationship to study treatment.|At initiation of treatment throughout study, to a minimum of 30 days after last dose of study drug|All randomized participants who received any study drug.||Participants|||Number
727863|NCT00370552|Secondary|Percentage of Participants Surviving at 1 Year|One year survival rates were computed using Kaplan-Meier estimates.|Date first participant enrolled to 1 year|All randomized participants.||Percentage of participants||95% Confidence Interval|Number
727864|NCT00370552|Secondary|Median Duration of Response|Duration of response was computed for participants whose best response was either PR or CR. Duration of overall response was defined as the period from the time that measurement criteria were first met for PR or CR, whichever was recorded first, until the first date of documented PD or death. Participants who neither relapsed nor died were to be censored on the date of their last tumor assessment.|Date of first PR or CR assessment to date of progression, death, or last tumor assessment (maximum participant duration of response of 25 weeks)|Participants whose best response was CR or PR, as assessed by the investigator.||Months||95% Confidence Interval|Median
727865|NCT00370552|Secondary|Median Time to Response|Time to response was defined as the time from the first dose of study therapy until measurement criteria were first met for a PR or CR, whichever was recorded first. Time to response was computed only for participants whose best response was PR or CR.|Date of first PR or CR assessment to date of progression, death, or last tumor assessment (maximum participant time to response of 67 weeks)|Participants whose best response was CR or PR, as assessed by the investigator.||Weeks||Full Range|Median
727866|NCT00370552|Secondary|Median Progression-free Survival (PFS)|PFS was defined as the time from randomization to progression or to death from any cause without prior documentation of progression. Participants who did not progress or die were to be censored on the date of their last tumor assessment.|Date of randomization to date of progression, death, or last tumor assessment (maximum participant PFS of 29 months)|All randomized participants.||Months||95% Confidence Interval|Median
727867|NCT00370552|Secondary|Percentage of Participants With Progression-free Survival at Week 24|Week 24 Progression-free Survival was defined as the number of participants who neither progressed nor died before Week 24. Computed using Kaplan-Meier estimates, only at the time of Interim Analysis, when all participants had been followed for 6 months.|Date of randomization to Week 24|All randomized participants||Percentage of participants||95% Confidence Interval|Number
727868|NCT00370552|Primary|Percentage of Participants With Best Tumor Response of Partial Response (PR) or Complete Response (CR) While On-study|CR=Disappearance of all clinical and radiologic evidence of target lesions; PR=At least 30% reduction in the sum of the longest diameter of all target lesions.|Baseline visit and then every 8 weeks to 12 months, then every 3 months until disease progression|All randomized participants||Percentage of participants||95% Confidence Interval|Number
727869|NCT00370682|Secondary|Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose|"Percentage of subjects with incidence of measurable dengue viremia at specified time points after each dose.
Negative = GEQ/uL results is equal to zero Undetermined = GEQ/uL result is below LOD Positive = GEQ/uL result is >=LOD Missing = No data PI(M1) = Post Dose 1, Month 1 PII(D2,5,8,12) = Post Dose 2, Days 2, 5,8 and 12 PII(D5,8,12,14) = Post Dose 2, Days 5, 8, 12 and 14 PII(M7) = Post Dose 2, Month 7"|within 7 months|||% of subjects|||Number
727870|NCT00370682|Secondary|Neutralizing Antibody Sero-response to Each DEN Type (Increase Neut.) Antibody From pre-to Post-vaccination, to be Determined by a Qualified Assay) After Each Dose of Study Vaccines|"Seropositivity rates for neut. antibodies according to pre-vaccination flavivirus immune status-primed/unprimed subjects.
PRE = Pre-vaccination PI(M1) = Post Dose 1, Month 1 PII(M7) = Post Dose 2, Month 7 PII(M9) = Post Dose 2, Month 9"|9 months|||% of subjects||95% Confidence Interval|Number
727874|NCT00370682|Secondary|Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose|"Laboratory valuesabove the alert values within 31 days (days 0-30) after each vaccine dose. Change from baseline in hematological and biochemical levels with respect to normal ranges.
PI(D2, 5, 8, 12) = Post Dose 1, Days 2, 5, 8 and 12 PI(D5, 12,14) = Post Dose 1, Days 5, 12 and 14 PI(M1) = Post Dose 1, Month 1 PI(M6) = Post Dose 1, Month 6 PII(D2, 5, 8, 12) = Post Dose 2, Days 2, 5, 8 and 12 PII(D5, 8, 12, 14) = Post Dose 2, Days 5, 8, 12 and 14 PII(M7) = Post Dose 2, Month 7"|within 31 days after each vaccine dose|||subjects|||Number
727875|NCT00370682|Secondary|Incidence of Serious Adverse Events (SAEs) Throughout the Entire Study Period|Number of subjects experiencing serious adverse events (SAEs) throughout the entire 9 month study period|9 months|||Participants|||Count of Participants
727876|NCT00370682|Secondary|Incidence of Unsolicited AEs Within 31 Days (Days 0-30) After Any Study Vaccine Dose|Incidence of unsolicited AEs reported within the 31-day (Days 0-30) post-vaccination period for each study vaccine|0-30 days after each study vaccine dose|||unsolicited AEs|||Number
727877|NCT00370682|Secondary|Subjects With Any Adverse Events (AEs) Within 21 Days Follow-up After Dose 2 of Study Vaccine|Percentage of subjects with any adverse events (AEs) solicited and unsolicited reported during the 21-day post-vaccination period following dose 2|0-21 days after dose 2 of study vaccine|||percentage of subjects||95% Confidence Interval|Number
727878|NCT00370682|Primary|Neutralizing Antibody Geometric Mean Titer (GMT) to DEN Types 1, 2, 3 and 4; 30 and 90 Days After Dose 2|Neutralizing antibody geometric mean titer (GMT) to DEN types 1, 2, 3 and 4 will be measured 30 and 90 days following the administration of the 2nd dose (6 month)|30 and 90 days after dose 2|||GMTs||95% Confidence Interval|Mean
727879|NCT00370682|Primary|Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1|Percentage of subjects with any grade 3 adverse events (AEs) within 21 days follow-up after dose 1 (0 month)|0-21 days after dose 1|||percentage of subjects||95% Confidence Interval|Number
727880|NCT00370838|Primary|Total Tic Score|The TTS is a portion of the YGTSS [Leckman et al., 1989], and consists of separate rating of motor (0-25) and vocal (0-25) tics. Ratings are made along 5 discriminant dimensions, scaled 0-5 for each including number, frequency, intensity, complexity, and interference. Total of these scores (0-50) is a Total Tic Score (TTS). A score of 0 represent no tics present, a score of 50 represents the most severe tics in each category listed.|Baseline (Day 8 or Day 64), Final (6 weeks later: Day 50 or Day 106)|||scores on a scale||Standard Deviation|Mean
727881|NCT00370838|Secondary|Modified Pittsburgh Side Effect Scale|"Side effects will be assessed by an expanded (modified) Pittsburgh Side Effect Scale modified to include side effects of levetiracetam and clonidine. Significant adverse events will be reported to the UCB, JCCI, and FDA within 24 hours. Positive responses are tallied as number of side effects for the responding period."|Baseline (Day 8 or Day 64), Final (6 weeks later: Day 50 or Day 106)|||Number of Side Effects||Standard Deviation|Mean
727882|NCT00370838|Secondary|Multidimensional Anxiety Scale for Children (MASC):|"The child's anxiety will be followed using the multidimensional Anxiety Scale for Children (MASC) (Stallings and March, 1995) and is now considered the preferred instrument for rating childhood anxiety. It is a 39-item questionnaire, ranking each item as Never, Rarely, Sometimes, or Often (0, 1, 2, 3). The sum of all responses yeilds a score (maximum MASC score is 117). A score of 0 represents no anxiety, and a score of 117 represents severe anxiety."|Baseline (Day 8 or Day 64), Final (6 weeks later: Day 50 or Day 106)|||scores on a scale||Standard Deviation|Mean
727883|NCT00370838|Secondary|DuPaul Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale:|The presence of Attention Deficit Hyperactivity Disorder (ADHD) symptoms are assessed using the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) version of the DuPaul ADHD rating scale, which incorporates the symptom items for ADHD from the DSM into a rating scale format that quantifies symptom severity. Each item is rated as not at all, just a little, pretty much, and very much (0, 1, 2, and 3). There are 18 items in total are summed, with a minimum score of 0 (meaning no inattention or hyperactivity) with a maximum score of 54 (severe inattention and hyperactivity).|Baseline (Day 8 or Day 64), Final (6 weeks later: Day 50 or Day 106)|||scores on a scale||Standard Deviation|Mean
727884|NCT00370838|Secondary|Child Yale-Brown Obsessive Compulsive Scale (CY-BOCS):|The severity of obsessive-compulsive disorder (OCD) is evaluated using the CY-BOCS [Scahill et al 1997]. Obsessions and compulsions are rated on 5 separate scales yielding three summary scores: Obsessions (0-20), Compulsions (0-20) and Total score (0-40). The CY-BOCS is the most widely used instrument to assess the severity of OCD symptoms in research studies. It includes checklist of specific obsessions and compulsions followed by examiner ratings of time spent, interference, distress, resistance and control over the obsessions and compulsions.0=no obsessions or compulsions; 40=most severe OC|Baseline (Day 8 or Day 64), Final (6 weeks later: Day 50 or Day 106)|||scores on a scale||Standard Deviation|Mean
727885|NCT00370838|Secondary|Clinical Global Impression-Improvement (CGI-I):|"Clinical Global Impression-Improvement (CGI-I): The CGI-I is used to compare current severity to baseline. A score of 1 corresponds to very much improved; 2 equals much improved; 3 denotes minimal change; and 4 represents no change. Scores above 4 are used to indicate deterioration, i.e., 5 equals minimally worse; 6 is much worse; and 7 is very much worse."|Baseline (Day 8 or Day 64), Final (6 weeks later: Day 50 or Day 106)|||scores on a scale||Standard Deviation|Mean
727886|NCT00370838|Primary|Yale Global Tic Severity Scale (YGTSS):|The YGTSS is a semi-structured clinical interview designed to measure current tic severity [Leckman et al., 1989], and consists of separate rating of motor (0-25) and vocal (0-25) tics. Ratings are made along 5 discriminant dimensions, scaled 0-5 for each including number, frequency, intensity, complexity, and interference. Total of these scores (0-50) is a Total Tic Score (TTS). The YGTSS contains an impairment ranking, 0-50 points, based on the impact of the tic disorder on areas such as self esteem, family life, social acceptance, and school. 0=no tics present; 100=most severe tics.|Baseline (Day 8 or Day 64), Final (6 weeks later: Day 50 or Day 106)|||scores on a scale||Standard Deviation|Mean
727887|NCT00370994|Secondary|Functional Status|Oswestry Disability Index (ODI) – ODI score is ranged from 0 to 50. Total score is converted in to percent disability. ODI Scoring: 0% to 20% (minimal disability), 21%-40% (moderate disability), 41%-60% (severe disability), 61%-80% (crippled) and 81%-100 These patients are either bed-bound or exaggerating their symptoms.|3, 6, 12, 18 and 24 months post treatment.|||units on a scale||Standard Deviation|Mean
729353|NCT00389805|Secondary|Analysis of Molecular Determinants in Tumor Samples (Phase II)|Expression of relevant molecular targets of the proteasome, which is inhibited by bortezomib.|Up to 36 months|The Phase II study was not conducted.|||||
727889|NCT00371137|Primary|Pain VAS (Visual Analog Scale) Response. Percentage of Subjects With a Greater Than or Equal to 30% Reduction in Pain VAS From Baseline (BOCF).|Percentage of pain VAS responders. Subjects with a >= 30% reduction in pain VAS from baseline to endpoint (week 14) were considered responders; all other subjects were considered non-responders. Missing data were handled using BOCF (Baseline Observation Carried Forward). The pain VAS ranges from 0 (no pain) to 100 (worst imaginable pain). The pain VAS was collected morning, afternoon and evening. Baseline is the average value recorded for the measure during the week prior to the end-of-baseline visit. Endpoint is the average value recorded for the measure during the week prior to week 14.|Baseline to Week 14|||Percentage of Participants|||Number
727890|NCT00371150|Secondary|Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry|The modified World Health Oranization(WHO)grading system was used to grade the abnormalities. ULN=upper limit of normal. Alanine aminotransferase:>1.25xULN, Aspartate aminotransferase:>1.25xULN, Alkaline Phosphatase:>1.25xULN, Total Bilirubin:>1.1xULN, Serum Lipase:>1.10xULN, Creatinine:>1.1xULN, Blood Urea Nitrogen:1.25xULN, Hyperglycemia:>116 mg/dL, Hypoglycemia:<64 mg/dL, Hyponatremia:<132meq/L, Hypokalemia:<3.4 meq/L, Albumin:≥1g/dL decrease from baseline, <3 g/dL; Hypernatremia:>148 meq/L, Hyperkalemia:>5.6 meq/L, Hypokalemia:<3.4 meq/L, Hyperchloremia:>113 meq/L, Hypochloremia:<93 meq/L|OT: From start of study therapy through Week 52 + 5 days; OF= End of OT period + 24-week follow-up|All treated participants. n = number of participants in the OF period.||participants|||Number
727891|NCT00371150|Primary|Percentage of Participants With HBV Deoxyribonucleic Acid (DNA) < 50 IU/mL by Polymerase Chain Reaction (PCR) at Week 48|HBV DNA assessments were performed using the Roche COBAS® TaqMan AmpliPrep assay. HBV DNA < 50 IU/mL = approximately <300 copies/mL.|Week 48 of ETV treatment|All treated participants. If a participant is missing the efficacy assessments for a visit, this is considered a failure and is counted as evaluable.||percentage of participants||95% Confidence Interval|Number
727892|NCT00371150|Secondary|Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF): Hematology|Criteria for hematology abnormalities were graded using the modified WHO grading system. Hemoglobin: <=11.0 g/dL; White Blood Cells: <4000/mm^3; Absolute Neutrophils (includes absolute bands): <1500/mm^3; Platelets: <=99,000/mm^3; International Normalized Ratio: ≥ 1.5 and ≥ 0.5 from baseline.|OT: From start of study therapy through Week 52 + 5 days; OF= End of OT period + 24-week follow-up|All treated participants. n = number of participants in the OF period.||participants|||Number
727893|NCT00371150|Secondary|Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations From Study Drug Due to Adverse Events|AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to any AEs were recorded.|From enrollment through Week 52 + 5 days|All treated participants.||participants|||Number
727894|NCT00371150|Secondary|Percentage of Participants With HBV DNA < Other IU Cut-off Points That May be Clinically Relevant at the Time of Data Analysis||Week 48|Since there were no other cut-off points other than those at the time of data analysis, this outcome was not analysed.||percentage of participants|||Number
727895|NCT00371150|Secondary|Mean log10 Reduction From Baseline in HBV DNA at Week 48|HBV DNA was analyzed by PCR, using the Roche COBAS®TaqMan TaqMan AmpliPrep assay. Reduction in log10 HBV count=reduced viral load.|baseline, Week 48|All treated participants. The participants who discontinued prior to Week 48 were counted as failure.||log10 IU/mL||Standard Error|Mean
727896|NCT00371150|Secondary|Percentage of Participants With HBsAg Seroconversion at Week 48|HBsAg = a part of the hepatitis B virus that, when in the blood, is a of infection. HBs seroconversion is defined as HBsAg loss with positive HBsAb.|Week 48|All treated participants. If a participant was missing the efficacy assessments for a visit, this is considered a failure and was counted as evaluable.||percentage of participants|||Number
727897|NCT00371150|Secondary|Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 48|HBsAg = a part of the hepatitis B virus that, when in the blood, is a marker of infection. HBsAg loss = HBsAg-negative at the specified analysis week.|Week 48|All treated participants. If a participant was missing the efficacy assessments for a visit, this is considered a failure and was counted as evaluable.||percentage of participants|||Number
727898|NCT00371150|Secondary|Percentage of Participants With HBeAg Seroconversion at Week 48 (for HBeAg-positive Participants Only)|HBeAg is a hepatitis B viral protein. HBeAg Seroconversion = HBeAg Loss and Presence of Hepatitis B e Antibody (HBeAb).|Week 48|Treated HBeAg-positive participants. If a participant was missing the efficacy assessments for a visit, this is considered a failure and was counted as evaluable.||percentage of participants|||Number
727899|NCT00371150|Secondary|Percentage of Participants With Confirmed HBeAg Loss at Week 48 (for HBeAg-positive Participants Only)|HBeAg is a hepatitis B viral protein. HBeAg loss = HBeAg-negative at the specified analysis week|Week 48|Treated HBeAg-positive participants. If a participant was missing the efficacy assessments for a visit, this is considered a failure and was counted as evaluable.||percentage of participants|||Number
727900|NCT00371150|Secondary|Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48|ALT normalization=ALT level being less than or equal to 1 times the upper limit of normal (ULN). ULN for ALT is 37 U/L.|Week 48|All treated participants. If a participant is missing the efficacy assessments for a visit, this is considered a failure and is counted as evaluable.||percentage of participants|||Number
727901|NCT00371150|Secondary|Percentage of Participants With Virologic Rebound Through Week 48 While on Continued Dosing With ETV|Virologic rebound is defined as a confirmed increase of ≥ 1 log10 in HBV DNA from the participant’s nadir value (2 sequential HBV DNA measurements or last on-treatment measurement)|through Week 48|All treated participants. The participants who discontinued prior to Week 48 were counted as failure.||percentage of participants|||Number
727902|NCT00371150|Secondary|Percentage of Participants With HBV DNA by PCR Category at Week 48|HBV DNA assessments were performed using the Roche COBAS® TaqMan AmpliPrep assay.|Week 48|All treated participants. If a participant is missing the efficacy assessments for a visit, this is considered a failure and is counted as evaluable.||percentage of participants|||Number
728775|NCT00384956|Secondary|Rate of Relapse After Hematopoietic Stem Cell Transplant in Individuals Treated With 5-azacitidine Prior to Transplant.||2 years after first dose of study drug or until participant is lost to follow-up or dies|This secondary outcome was not analyzed.|||||
727903|NCT00371150|Secondary|Percentage of Participants Who Achieve HBV DNA < Lower Limit of Quantitation (LOQ = 29 IU/mL [Approximately 169 Copies/mL]) at Week 48|HBV DNA assessments were performed using the Roche COBAS® TaqMan AmpliPrep assay. LOQ is the level above which quantitative results may be obtained with a specified degree of confidence. The LOQ is mathematically defined as equal to 10 times the standard deviation of the results for a series of replicates used to determine a justifiable limit of detection.|Week 48|All treated participants. If a participant is missing the efficacy assessments for a visit, this is considered a failure and is counted as evaluable.||percentage of participants||95% Confidence Interval|Number
727904|NCT00371176|Secondary|Beck Depression Inventory|A 21-item, self-report measure of depression symptoms. The range of scores is 0-63, with a higher value representing a worse outcome.|6 month follow-up|||units on a scale||Standard Deviation|Mean
727905|NCT00371176|Secondary|Beck Depression Inventory|A 21-item, self-report measure of depression symptoms. The range of scores is 0-63, with a higher value representing a worse outcome.|3 month follow-up|||units on a scale||Standard Deviation|Mean
727906|NCT00371176|Secondary|Beck Depression Inventory|A 21-item, self-report measure of depression symptoms. The range of scores is 0-63, with a higher value representing a worse outcome.|Post intervention|||units on a scale||Standard Deviation|Mean
727907|NCT00371176|Secondary|Beck Depression Inventory|A 21-item, self-report measure of depression symptoms. The range of scores is 0-63, with a higher value representing a worse outcome.|Pre intervention|||units on a scale||Standard Deviation|Mean
727908|NCT00371176|Secondary|PTSD Checklist|A 17-item, self-report measure of PTSD symptoms. The range of scores is 17-85, with a higher value representing a worse outcome.|6 month follow-up|||units on a scale||Standard Deviation|Mean
727909|NCT00371176|Secondary|PTSD Checklist|A 17-item, self-report measure of PTSD symptoms. The range of scores is 17-85, with a higher value representing a worse outcome.|3 month follow-up|||units on a scale||Standard Deviation|Mean
727910|NCT00371176|Primary|Clinician Administered PTSD Scale-IV|A 17-item, semi-structured interview of PTSD symptoms. The range of scores is 0-136, with a higher value representing a worse outcome.|6 month follow-up|||units on a scale||Standard Deviation|Mean
727911|NCT00371176|Primary|Clinician Administered PTSD Scale-IV|A 17-item, semi-structured interview of PTSD symptoms. The range of scores is 0-136, with a higher value representing a worse outcome.|3 month follow-up|||units on a scale||Standard Deviation|Mean
727912|NCT00371176|Primary|Clinician Administered PTSD Scale-IV|A 17-item, semi-structured interview of PTSD symptoms. The range of scores is 0-136, with a higher value representing a worse outcome.|Post Intervention|||units on a scale||Standard Deviation|Mean
727913|NCT00371176|Secondary|PTSD Checklist|A 17-item, self-report measure of PTSD symptoms. The range of scores is 17-85, with a higher value representing a worse outcome.|Post intervention|||units on a scale||Standard Deviation|Mean
727914|NCT00371176|Secondary|PTSD Checklist|A 17-item, self-report measure of PTSD symptoms. The range of scores is 17-85, with a higher value representing a worse outcome.|Pre Intervention|||units on a scale||Standard Deviation|Mean
727915|NCT00371176|Primary|Clinician Administered PTSD Scale-IV|A 17-item, semi-structured interview of PTSD symptoms. The range of scores is 0-136, with a higher value representing a worse outcome.|Pre Intervention|||units on a scale||Standard Deviation|Mean
727916|NCT00371254|Secondary|Number of Participants With Abnormal Vital Signs Measurements|Vital signs included systolic and diastolic blood pressure and heart rate. The investigator used his or her judgement to decide whether or not the values were abnormal.|At each study visit (Week 3, 5, 7, 9, 13, 17 and 25) and end of treatment (up to 17 weeks)|All treated participants||participants|||Number
727917|NCT00371254|Secondary|Number of Participants With Identified Electrocardiogram (ECG) Abnormalities|ECGs were performed and all recordings were evaluated by the investigator. Abnormalities, if present at any study time point, were listed. The following ECG variables were collected: heart rate, PR interval, QRS width, and QT interval. Abnormalities in ECGs were defined by reference to institutional reports.|Baseline, Weeks 3, 9, 17 and 25, then every 8 weeks until the end of study treatment (up to 17 weeks).|All treated participants||participants|||Number
727918|NCT00371254|Secondary|Number of Participants With Grade 3 or 4 Serum Chemistry Abnormalities in Creatinine, Bicarbonate, Inorganic Phosphorous and Bilirubin (Total).|Abnormalities were graded according to the NCI CTC, version 3.0: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening. Grade 3 and 4 criteria are defined as follows: Creatinine: Grade 3-4 : > 3.0 -6.0 ULN (upper limit of normal),Bicarbonate: Grade 3-4: <16 -<22 mEq/L, Phosphorous: Grade 3-4 : <1.0 - <2.0 mg/dL, Bilirubin, total: Grade 3-4: >3.0 - >10.0 ULN.|Throughout study, from start of study drug therapy up to 30 days after the last dose.|All treated participants||participants|||Number
727919|NCT00371254|Secondary|Number of Participants With Grade 3 or 4 Serum Chemistry Abnormalities in Calcium, Potassium, Magnesium and Sodium|Abnormalities were graded according to the NCI CTC, version 3.0: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening. Grade 3 and 4 criteria are defined as follows: Calcium: Grade 3-4 : <6.0 – <7.0 or >12.5 – >13.5 mg/dL, Potassium: Grade 3-4 : <2.5 – <3.0 or >6.0 – >7.0 mEq/L, Magnesium: Grade 3-4 : <0.6 - <0.8 or >2.46 - >6.6 mEq/L, Sodium:< 120– 130 or >155 – >160 mEq/L.|Throughout study, from start of study drug therapy up to 30 days after the last dose.|All treated participants||participants|||Number
727920|NCT00371254|Secondary|Number of Participants With Grade 3 or 4 Serum Chemistry Abnormalities in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Alkaline Phosphatase|Abnormalities were graded according to the NCI CTC, version 3.0: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening. Grade 3 and 4 criteria are defined as follows: ALT, AST and alkaline phosphatase: Grade 3: >5-20 x upper limit of normal (ULN), Grade 4: >20 x ULN.|Throughout study, from start of study drug therapy up to 30 days after the last dose.|All treated participants||participants|||Number
727921|NCT00371254|Secondary|Number of Participants With Abnormalities (Grade 1 or 2) in Partial Thromboplastin Time (PTT)|PTT is a measure of the clotting ability of the blood. Abnormalities were graded according to the NCI CTC, version 3.0: Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life-threatening and 5=death.|Throughout study, from start of study drug therapy up to 30 days after the last dose.|All treated participants.||Participants|||Number
728076|NCT00371826|Secondary|Number of Participants With Erythropoietin Usage (12 Months Analysis)||Month 12|Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication.||participants|||Number
727923|NCT00371254|Secondary|Number of Participants With Grade 3 or 4 Abnormalities in Hematology Measurements|Abnormalities were graded according to the NCI CTC, version 3.0: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening. Grades 3 and 4 criteria are defined as follows: Granulocytes: Grade 3 <1.0 - 0.5 x 10^9/L; Grade 4, <0.5 x 10^9/L. Hemoglobin: Grade 3, <8.0 - 6.5 g/dL; Grade 4, <6.5 g/dL. Platelets: Grade 3, <50.0 - 25.0 x 10^9/L; Grade 4, <25.0 x 10^9/L. Leukocytes: Grade 3, <2.0 - 1.0 x 10^9/L; Grade 4, <1.0 x 10^9/L.|Throughout study, from start of study drug therapy up to 30 days after the last dose.|All treated participants||participants|||Number
727924|NCT00371254|Secondary|Most Frequent Drug-related Adverse Events (AEs)|Most frequent drug-related AEs are those AEs with frequency >=25% in either group. Drug-related AEs are those events with relationship to study therapy of certain, probable or possible.|From start of study drug therapy up to 30 days after the last dose.|All treated participants||participants|||Number
727925|NCT00371254|Secondary|Number of Participants Who Experienced Drug-related SAEs, Drug-related AEs, Drug-related Grade 3 AEs and Discontinuations Due to Drug-related AEs|AE=any new untoward medical occurrence/worsening of pre-existing medical condition.SAE=AE that resulted in death, was life-threatening, required hospitalization (or prolongation of existing hospitalization), or was an important medical event. Drug-related SAEs or AEs are those events with relationship to study therapy of certain, probable or possible.AEs were graded using the National Cancer Institute (NCI) Common Toxicity Criteria (CTC), v3: Grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death.Participants who discontinued the study due to any drug-related AEs were also recorded.|From start of study drug therapy up to 30 days after the last dose.|All treated participants||participants|||Number
727926|NCT00371254|Secondary|Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs) or Adverse Events (AEs)|An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition (even if not caused by the study drug). An SAE was defined as an AE that resulted in death, was life-threatening, required hospitalization (or prolongation of existing hospitalization), or was an important medical event.|From start of study drug therapy up to 30 days after the last dose.|All treated participants.||participants|||Number
727927|NCT00371254|Secondary|Profiling of Messenger-ribonucleic Acid (mRNA) Expression: mRNA Signal Intensity|Pharmacogenomic analysis included the assessment of the relationship between clinical benefit and mRNA expression levels and between clinical benefit and protein phosphorylation. Tumor mRNA expression was analyzed in all available tissues. mRNA was extracted from 96 formalin-fixed paraffin-embedded tissue (FFPET) samples, amplified, and fluorescently labeled. Gene expression profiling was conducted using Affymetrix Human Genome U133A 2.0 DNA microarrays. mRNA expression is reported as quantile normalized RMA values.|Baseline|All treated participants who were evaluable for the analysis. These data for pharmacogenomic analyses were integrated with those from other studies and are not reportable for this study alone.||log2 scale (unitless)|||Number
727928|NCT00371254|Secondary|Percentage Change in Tumor Biomarkers|Tumor markers are indicators of tumor activity which may be used to predict clinical benefit and circulating biomarkers may reveal key mechanisms of action. Tissue staining was performed for caveolin, phospho-caveolin, EphA2 and insulin-like growth factor binding protein 2 (IGFBP2) markers using immunohistochemistry assays.|Baseline|All treated participants who were evaluable for the analysis. These data for tumor markers were integrated with those from other studies and are not reportable for this study alone.||percentage||Inter-Quartile Range|Median
727929|NCT00371254|Secondary|Mean Change in Concentration of Vascular Endothelial Growth Factor Receptor-2 (VEGFR2) From Baseline|VEGFR2 is a measure of anti-angiogenic activity. Plasma samples for assessment of change in concentration of VEGFR2 were obtained and analyzed by enzyme-linked immunosorbent assay.|Baseline, Week 3 and Week 5|Participants who were evaluable for pharmacodynamic analysis.||percentage of baseline||90% Confidence Interval|Geometric Mean
727930|NCT00371254|Secondary|Mean Change in Concentration of Collagen Type IV From Baseline|Collagen Type IV is a measure of anti-angiogenic activity. Plasma samples for assessment of change in concentration of Collagen Type IV were obtained and analyzed by enzyme-linked immunosorbent assay.|Baseline, Week 3 and Week 5|Participants who were evaluable for pharmacodynamic analysis.||percentage of baseline||90% Confidence Interval|Geometric Mean
727931|NCT00371254|Secondary|Mean Plasma Concentration at Week 7|Mean plasma concentration was obtained directly from the concentration-time data.|At pre-dose and 1, 3, 6 and 12 hours after each dose administration|"Participants who were evaluable for pharmacokinetic analysis. n signifies the number of participants evaluable at each time point."||nanograms (ng)/mL||Standard Deviation|Mean
727932|NCT00371254|Primary|Percentage of Participants With Complete Response (CR) or Partial Response (PR)|The percentage of participants whose best response was CR or PR, per the RECIST: CR: disappearance of all target/non-target lesions; PR: >= 30% decrease in the sum of the LDs of target lesions relative to the baseline sum LD.|Baseline to end of study drug therapy (up to 65 weeks).|All response-evaluable participants i.e. all treated participants who had at least 1 measurable lesion at baseline, 1 on-study tumor assessment or discontinued before any on-study tumor assessment for reasons related to disease or study drug were included in this dataset.||percentage of participants||95% Confidence Interval|Number
727933|NCT00371254|Secondary|Mean Plasma Concentration at Week 3|Mean plasma concentration was obtained directly from the concentration-time data.|At pre-dose and 1, 3, 6 and 12 hours after each dose administration|"Participants who were evaluable for pharmacokinetic analysis. n signifies the number of participants evaluable at each time point."||nanograms (ng)/mL||Standard Deviation|Mean
727934|NCT00371254|Secondary|Mean Number of Weeks of Complete Response (CR) or Partial Response (PR)|Mean number of weeks of CR/PR (time from first date of CR/PR until first date PD observed. Tumor response defined per RECIST: CR: disappearance of all target/non-target lesions; PR: >=30% decrease in sum of LDs of target lesions relative to baseline sum LD; PD: appearance of new lesion or >=20% increase in sum of LD of target lesions relative to smallest sum LD or unequivocal progression of existing non-target lesions. Participants who died without reported PD were considered to have PD on date of death. For participants who neither progressed nor died, date of last tumor assessment used.|Baseline to end of study drug therapy (up to 53.86 weeks)|Response-evaluable participants who achieved a complete response (CR) or partial response (PR)||weeks||Full Range|Mean
728399|NCT00380068|Secondary|Failure-free Treatment Status|Defined by occurrence of death, lung transplantation, or study withdrawal due to the addition of other clinically approved PAH therapeutic agents|Baseline to Week 48|Full Analysis Set. Participants who were lost to follow-up were censored at the date of last contact.||Percentage of participants|||Number
727935|NCT00371254|Secondary|Proportion of Participants With Progression-Free Survival (PFS) at Weeks 9, 17, and 25|PFS:time from first dose until the date that progressive disease (PD) or clinical PD (cPD) observed,per RECIST criteria.PD:appearance of new lesion/s,or >=20% increase in the sum of the LD of target lesions,relative to smallest sum LD recorded since treatment start,or unequivocal progression of existing non-target lesions;cPD:deterioration related to disease requiring treatment discontinuation,but without radiographic PD.Participants who died without PD were considered to have PD on the date of death.For participants who neither progressed nor died,date of the last tumor assessment was used.|Weeks 9, 17, and 25|All treated participants||Proportion of Participants|||Number
727936|NCT00371254|Secondary|Percentage of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) at or After 16 Weeks on Study|The percentage of participants whose best response was CR, PR or SD (per the RECIST) at or after 16 weeks on study: CR: disappearance of all target/non-target lesions; PR: >=30% decrease in the sum of the LDs of target lesions relative to baseline sum LD; SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; PD: appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.|Baseline to 16 weeks|All response-evaluable participants i.e. all treated participants who had at least 1 measurable lesion at baseline, had at least 1 on-study tumor assessment or discontinued before any on-study tumor assessment for reasons related to disease or study drug.||percentage of participants||95% Confidence Interval|Number
727937|NCT00371254|Secondary|Number of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) at or After 16 Weeks on Study|The number of participants whose best response was CR, PR or SD (per the RECIST) at or after 16 weeks on study: CR: disappearance of all target/non-target lesions; PR: >=30% decrease in the sum of the LDs of target lesions relative to baseline sum LD; SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; PD: appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.|Baseline to 16 weeks.|All response-evaluable participants i.e. all treated participants who had at least 1 measurable lesion at baseline, had at least 1 on-study tumor assessment or discontinued before any on-study tumor assessment for reasons related to disease or study drug.||Participants|||Number
727938|NCT00371254|Primary|Number of Participants With Complete Response (CR) or Partial Response (PR)|Tumor response was defined as the number of participants whose best response was CR or PR, per the Response Evaluation Criteria in Solid Tumor (RECIST): CR: disappearance of all target/non-target lesions; PR: >= 30% decrease in the sum of the LDs of target lesions relative to the baseline sum LD.|Baseline to end of study drug therapy (up to 65 weeks).|All response-evaluable participants i.e. all treated participants who had at least 1 measurable lesion at baseline, had at least 1 on-study tumor assessment or discontinued before any on-study tumor assessment for reasons related to disease or study drug.||participants|||Number
727939|NCT00371267|Secondary|Pain Intensity Rating|Measure of rated pain intensity Score = mean Range: 0-5; higher scores = more intense pain|46 weeks|Veterans with chronic pain||units on a scale||Standard Deviation|Mean
727940|NCT00371267|Secondary|Pain Behavior Checklist Total Score|Assessment of behavioral expression of pain Total Score = mean of item scores Range: 0-6; higher = more pain behavior|46 weeks|Veterans with chronic pain||units on a scale||Standard Deviation|Mean
727941|NCT00371267|Primary|Short Form-12 Mental Health|Daily functioning, quality of life Range: 0-100; higher scores = higher level of functioning Score: sum of weighted subscale scores|46 weeks|Veterans with chronic pain||units on a scale||Standard Deviation|Mean
727942|NCT00371267|Secondary|Beck Depression Inventory (BDI)-2 Total Score|Measure of symptoms of depression indicating severity of depression Total Score = sum of item scores Range: 0-63; higher scores = greater severity of depression|46 weeks|Veterans with chronic pain||units on a scale||Standard Deviation|Mean
727943|NCT00371267|Primary|Short Form-12 Physical Health|Level of physical functioning in daily living, health-related quality of life Range: 0-100; higher score = higher functioning Score: Sum of weighted subscale scores|46 weeks|Veterans with chronic pain||units on a scale||Standard Deviation|Mean
727944|NCT00371293|Secondary|Change in HDL Cholesterol Levels||Measured at Baseline and Week 24|||mg/dL||95% Confidence Interval|Mean
727945|NCT00371293|Secondary|Change in Triglyceride Levels||Measured at Baseline and Week 24|||mg/dL||95% Confidence Interval|Mean
727946|NCT00371293|Secondary|Change in LDL Cholesterol Levels||Measured at Baseline and Week 24|||mg/dL||95% Confidence Interval|Mean
727947|NCT00371293|Secondary|Change in Insulin Resistance (Insulin Sensitivity Index, x10-4/Min−1/μU/ml)|Assessed using the frequently sampled intravenous glucose tolerance test (FSIGTT) which evaluates blood glucose and insulin levels. Insulin sensitivity is estimated using the Bergman’s minimal model.|Measured at Baseline and Week 24|||x10-4/min−1/μU/ml||95% Confidence Interval|Mean
727948|NCT00371293|Primary|Inflammation||Measured at Baseline and Week 24|||percentage of change in crp at week 24||95% Confidence Interval|Mean
727949|NCT00371345|Secondary|Pharmacodynamics: Percent Change From Baseline In Plasma Level of VEGFR2 at Week 5 in Participants With and Without DCR|VEGF-stimulated disruption of the cadherin-catenin complex leads to tumor cell invasion and metastasis. VEGFR2 plasma levels were assayed by ELISA as a marker of VEGF pathway modulation.|At Baseline and Week 5 of treatment|Number of Participants Analyzed=All Treated Participants with samples for PD analysis, n=number of participants at specified time point with samples for PD analysis||percent change||90% Confidence Interval|Mean
727950|NCT00371345|Primary|Best Overall Response|Response assessed using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)=disappearance of all target and non-target lesions; Partial Response (PR)=≥30% decrease in sum of longest diameter (LD) of target lesions; SD=small changes not meeting above criteria; Progressive Disease (PD)=appearance of new lesion(s), ≥ 20% increase in the sum of the LD of target lesions, or progression of existing non-target lesions; Clinical Progression (cPD)=deterioration related to disease requiring treatment without radiographic PD.|From day of first treatment through Week 25 or at time of discontinuation from study treatment|Evaluable population (n=69): Response Evaluable=treated participants with ≥1 measurable lesion at baseline and ≥1 on-study tumor assessment; Non-responders=treated participants with no on-study tumor response assessment due to rapid disease progression/dasatinib toxicity. One participant was not evaluable (no on-study tumor assessment).||participants|||Number
727951|NCT00371345|Secondary|Pharmacodynamics: Percent Change From Baseline In Plasma Level of VEGFR2 at Week 3 in Participants With and Without DCR|VEGF-stimulated disruption of the cadherin-catenin complex leads to tumor cell invasion and metastasis. VEGFR2 plasma levels were assayed by ELISA as a marker of VEGF pathway modulation.|At Baseline and Week 3 of treatment (Day 15 ±4 days)|Number of Participants Analyzed=All Treated Participants with samples for PD analysis, n=number of participants at specified time point with samples for PD analysis||percent change||90% Confidence Interval|Mean
727952|NCT00371345|Secondary|Pharmacodynamics: Percent Change From Baseline In Plasma Level of Collagen Type IV at Week 5 in Participants With and Without DCR|Collagen Type IV is a circulating marker related to the modulation of the vascular endothelial growth factor (VEGF)-pathway. An assay of Collagen Type IV in plasma was performed by ELISA.|Week 5|Number of Participants Analyzed=All Treated Participants with samples for PD analysis, n=number of participants at specified time point with samples for PD analysis||percent change||90% Confidence Interval|Mean
727953|NCT00371345|Secondary|Pharmacodynamics: Percent Change From Baseline In Plasma Level of Collagen Type IV at Week 3 in Participants With and Without DCR|Collagen Type IV is a circulating marker related to the modulation of the vascular endothelial growth factor (VEGF)-pathway. An assay of Collagen Type IV in plasma was performed by ELISA.|At Baseline and Week 3 of treatment (Day 15 ±4 days)|Number of Participants Analyzed=All Treated Participants with samples for PD analysis, n=number of participants at specified time point with samples for PD analysis||percent change||90% Confidence Interval|Mean
727954|NCT00371345|Secondary|PK: Plasma Concentration of Dasatinib at Week 7 or Week 9|Blood samples (3 mL) were used for measurement of dasatinib plasma concentration and metabolites.|PK assessment was performed at Week 7 or 9 visit. Blood samples were obtained at Time = 0 hours, and at 1, 3 and 6 hours after each dose, and a trough sample was obtained immediately prior to any dose (~12 hours).|Number of Participants Analyzed=All Treated Participants with samples for PK analysis, n=number of participants at specified time point with samples for PK analysis||ng/ml||Standard Deviation|Mean
727955|NCT00371345|Secondary|Pharmacokinetics (PK): Plasma Concentration of Dasatinib at Week 3|Blood samples (3 mL) were used for measurement of dasatinib plasma concentration and metabolites.|PK assessment was performed at Week 3 visit (Day 15 ±4 days). Blood samples were obtained at Time = 0 hours, and at 1, 3 and 6 hours after each dose, and a trough sample was obtained immediately prior to any dose (~12 hours).|Number of Participants Analyzed=All Treated Participants with samples for PK analysis, n=number of participants at specified time point with samples for PK analysis||ng/ml||Standard Deviation|Mean
727956|NCT00371345|Secondary|Number Of Participants With Notable Drug-related AEs|Notable drug-related AEs for dasatinib include gastrointestinal symptoms (diarrhea, nausea, vomiting and abdominal pain), fatigue, lethargy, headache, rash, fever, pleural effusion, and dyspnea.|Continuous assessment beginning at initiation of study drug until 30 days after the last dose of study drug|All-Treated participants: All participants who received at least one dose of dasatinib.||participants|||Number
727957|NCT00371345|Secondary|Number of Participants With Serious AEs (SAEs), Drug-related AEs, Drug-related SAEs, and Drug-Related Grade 3 AEs|AEs and SAEs considered possibly, probably, or certainly related to study treatment, graded according to CTCAE Version 3.0 (Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death). SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|Continuous assessment beginning at initiation of study drug until 30 days after the last dose of study drug|All-Treated participants: All participants who received at least one dose of dasatinib.||participants|||Number
727958|NCT00371345|Secondary|Number of Participants With On-study CTCAE Version 3.0 Grade 3-4 Laboratory Abnormalities|Normal ranges for laboratory abnormalities: granulocytes=1.5x10^3-8x10^3 mm^3 (range may have varied by institution); hemoglobin=12-16 g/dL; platelets=150-440x10^9c/L; partial thromboplastin time=27-37.1 seconds; alkaline phosphatase=38-126 U/L; alanine aminotransferase=15-48 U/L; aspartate aminotransferase=14-38 U/L; creatine=0.7-1.1 mg/dL; hypokalemia (potassium [K])=3.5-5mEq/L; hyponatremia (sodium [Na])=135-145 mEq/L; phosphorous=2.4-4.5 mg/dL; bilirubin=0-1.2. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening/disabling, Gr 5=Death.|Continuous assessment beginning at initiation of study drug until 30 days after the last dose of study drug|All-Treated participants: All participants who received at least one dose of dasatinib.||participants|||Number
727959|NCT00371345|Secondary|Number of Participants With Death, Adverse Events (AEs), and AEs Leading to Discontinuation|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.|Continuous assessment beginning at initiation of study drug until 30 days after the last dose of study drug|All-Treated participants: All participants who received at least one dose of dasatinib.||participants|||Number
727960|NCT00371345|Secondary|Duration Of Objective Response|Duration of objective response was defined as the time (in weeks) between the first date that criteria for CR or PR were met and the first date that progressive disease (PD) or clinical progressive disease (cPD) was observed. Date of death was used as PD date for participants who died before reporting PD. Participants who neither progressed nor died were censored at the date of their last tumor assessment.|the time (in weeks) between the first date that criteria for PR were met and the first date that PD or cPD was observed|Of 69 response-evaluable participants, three had an objective response of PR.||weeks|||Number
727961|NCT00371345|Secondary|Percentage of Participants With Progression-free Survival (PFS) at Weeks 9, 17, and 25|PFS was defined as time from first dosing date until the first date that progressive disease (PD) was observed.|At Weeks 9, 17, and 25|Evaluable population (n=69): Response Evaluable=treated participants with ≥1 measurable lesion at baseline and ≥1 on-study tumor assessment; Non-responders=treated participants with no on-study tumor response assessment due to rapid disease progression/dasatinib toxicity. One participant was not evaluable (no on-study tumor assessment).||percentage of participants|||Number
728259|NCT00379574|Primary|Number of Patients Who Achieved Complete Response|All patients,9 patients of phase I study and 40 patietns in phase II stuay, were assessed with International Working Group response criteria assessed by CT; Complete Response (CR), Disappearance of all detectable clinical and radiographic evidence of disease and diappearance of all disease-related symptoms.|14 weeks|||participants|||Number
727962|NCT00371345|Secondary|Median Progression Free Survival (PFS)|PFS was defined as time from first dosing date until the first date that PD was observed. The distribution of PFS was estimated using the Kaplan-Meier product limit method. A two-sided 95% confidence interval (Brookmeyer and Crowley method) for the median PFS was computed.|From Baseline (Week 0) to time of PD or discontinuation of last participant from study treatment (Week 45)|All-Treated subjects: All subjects who received at least one dose of dasatinib. The longest on-study observation for a participant was 45 weeks.||weeks||95% Confidence Interval|Median
727963|NCT00371345|Secondary|Number of Participants Who Progressed|PFS was defined as time from first dosing date until the first date that Progressive Disease (PD) was observed.|From Baseline (Week 0) to time of PD or discontinuation of last participant from study treatment (Week 45)|All-Treated subjects: All subjects who received at least one dose of dasatinib. The longest on-study observation for a participant was 45 weeks.||participants|||Number
727964|NCT00371345|Secondary|Percentage of Response-evaluable Participants With Disease Control (DCR)|Disease control was defined in response-evaluable participants as having a best response of objective response (CR or PR) or SD at/after 16 Weeks.|From day of first treatment through Week 25 or at time of discontinuation from study treatment.|Evaluable population (n=69): Response Evaluable=treated participants with ≥1 measurable lesion at baseline and ≥1 on-study tumor assessment; Non-responders=treated participants with no on-study tumor response assessment due to rapid disease progression/dasatinib toxicity. One participant was not evaluable (no on-study tumor assessment).||percentage of participants||95% Confidence Interval|Mean
727965|NCT00371345|Secondary|Number of Response-evaluable Participants With Disease Control (DCR)|Disease control was defined in response-evaluable participants as having a best response of CR or PR (or uPR), or SD at/after 16 Weeks.|From day of first treatment through Week 25 or at time of discontinuation from study treatment.|Evaluable population (n=69): Response Evaluable=treated participants with ≥1 measurable lesion at baseline and ≥1 on-study tumor assessment; Non-responders=treated participants with no on-study tumor response assessment due to rapid disease progression/dasatinib toxicity. One participant was not evaluable (no on-study tumor assessment).||participants|||Number
727966|NCT00371345|Primary|Percentage of Participants With Objective Response|Tumor response was assessed according RECIST criteria: PR=at least 30% reduction in the sum of the LD of all target lesions in reference to the baseline sum LD, CR=Disappearance of all non-target lesions. Percentage of participants with objective tumor response was determined by the number of participants with PR or CR divided by the total number of response-evaluable participants.|From day of first treatment through Week 25 or at time of discontinuation from study treatment|Evaluable population (n=69): Response Evaluable=treated participants with ≥1 measurable lesion at baseline and ≥1 on-study tumor assessment; Non-responders=treated participants with no on-study tumor response assessment due to rapid disease progression/dasatinib toxicity. One participant was not evaluable (no on-study tumor assessment).||percentage of participants||95% Confidence Interval|Number
727967|NCT00371345|Primary|Number of Participants With Objective Response|Tumor response was assessed according RECIST criteria: PR=at least 30% reduction in the sum of the LD of all target lesions in reference to the baseline sum LD, CR=Disappearance of all non-target lesions. Objective tumor response was defined as a PR or CR.|From day of first treatment through Week 25 or at time of discontinuation from study treatment.|Evaluable population (n=69): Response Evaluable=treated participants with ≥1 measurable lesion at baseline and ≥1 on-study tumor assessment. One participant was not evaluable (no on-study tumor assessment for other reason).||participants|||Number
727968|NCT00371397|Secondary|Mood: Positive and Negative Affect Schedule (PANAS)Negative|The Positive and Negative Affect Schedule (PANAS) includes two 10-item mood scales. Each item is rated on a 5-point scale ranging from 1 = very slightly or not at all to 5 = extremely, to indicate the extent to which the respondent has felt this way in the indicated time frame. Several additional words were added to better capture low positive affect: happy, satisfied, disappointed, discouraged, low, sad.|7:35, 11:45, 12:30 at each of the three visits, scheduled at least 2 weeks apart||||||
727969|NCT00371397|Secondary|Mood: Positive and Negative Affect Schedule (PANAS)Positive|The Positive and Negative Affect Schedule (PANAS) includes two 10-item mood scales. Each item is rated on a 5-point scale ranging from 1 = very slightly or not at all to 5 = extremely, to indicate the extent to which the respondent has felt this way in the indicated time frame. Several additional words were added to better capture low positive affect: happy, satisfied, disappointed, discouraged, low, sad.|7:35, 11:45, 12:30 at each of the three visits, scheduled at least 2 weeks apart||||||
727970|NCT00371397|Secondary|Blood Pressure||7:55 at each of the three visits, scheduled at least 2 weeks apart||||||
727971|NCT00371397|Secondary|Heart Rate||Day 1: 8:30, 9:15, 9:45, 10:00, 10:45, 11:35, 12:05, 12:15||||||
727972|NCT00371397|Primary|Catecholamine Production: Norepinephrine|All cortisol and catecholamine samples for a subject were frozen after collection and analyzed within the same assay run after the participant had completed the study.|8:30, 10:05, 10:28, 10:58, 11:35, 12:05||||||
727973|NCT00371397|Primary|Catecholamine Production: Epinephrine|All cortisol and catecholamine samples for a subject were frozen after collection and analyzed within the same assay run after the participant had completed the study.|8:30, 10:05, 10:28, 10:58, 11:35, 12:05 at each of the three visits, scheduled at least 2 weeks apart||||||
727974|NCT00371397|Primary|Immune Function: Interleukin-6 (IL-6)|Serum levels of TNF-α, IL-6, and the sIL-6r were assayed using Quantikine High Sensitivity Immunoassay kits (R&D), per kit instructions|Day 1 8:30, 11:35, 13:10. Day 2 7:30||||||
727975|NCT00371397|Primary|Immune Function: LPS-stimulated Production of TNF-α|Supernatants from PBLs stimulated with 5μg/ml lipopolysaccharide (LPS) for 72 h were assayed for IL-6 and TNF-α using ELISA kits (B-D Pharmingen).|Day 1 8:30, 10:05, 11:35, 13:10. Day 2 7:30||||||
727976|NCT00371397|Primary|Immune Function: Lipopolysaccharide (LPS) -Stimulated Production of Interleukin-6 (IL-6)|Supernatants from PBLs stimulated with 5μg/ml lipopolysaccharide (LPS) for 72 h were assayed for IL-6 and TNF-α using ELISA kits (B-D Pharmingen).|Day 1 8:30, 10:05, 11:35, 13:10. Day 2 7:30||||||
727977|NCT00371397|Primary|Immune Function: Tumor Necrosis Factor-alpha (TNF-α)|Serum levels of TNF-α were assayed using Quantikine High Sensitivity Immunoassay kits (R&D), per kit instructions.|Day 1 8:30, 11:35, 13:10. Day 2 7:30||||||
727978|NCT00371397|Primary|Immune Function: Soluble Interleukin-6 Receptor (sIL-6r)|Serum levels of the sIL-6r were assayed using Quantikine High Sensitivity Immunoassay kits (R&D), per kit instructions.|Day 1 8:30, 11:35, 13:10. Day 2 7:30||||||
727979|NCT00371397|Primary|Skin Barrier Repair: Trans-epidermal Water Loss (TEWL)|Cellophane tape stripping, a common dermatological paradigm for studying restoration of the skin barrier, was used to examine whether the time necessary for recovery from minor physical insults varied by condition or yoga expertise. Measurement of the rate of transepidermal water loss (TEWL) through human skin provides a noninvasive method to monitor changes in the skin’s barrier function. TEWL was measured twice during the session using a computerized evaporimetry instrument, the DermaLab® (CyberDERM, Media, PA), and barrier recovery was calculated.|11:50, 12:50 at each of the three visits, scheduled at least 2 weeks apart||||||
727980|NCT00371397|Primary|Cortisol|All cortisol and catecholamine samples for a subject were frozen after collection and analyzed within the same assay run after the participant had completed the study.|Day 1 8:30, 10:05, 10:58, 11:35, 12:05, 13:10. Day 2 7:30||||||
727981|NCT00371397|Primary|Number of Participants With Detectable C-Reactive Protein (CRP)|High sensitivity C-reactive protein (hsCRP) assessed once at baseline, at each of the three visits. The hsCRP assay was performed using chemiluminescence methodology with the Immulite 1000 (Siemens Medical Solutions, Los Angeles, Ca.) The lowest level of detection is .3 mg/dL. 43% of the values were below this lower bound, thus hsCRP was dichotomized as undetectable/detectable.|8:30 a.m. at each of the three visits, scheduled at least 2 weeks apart|||participants with CRP above 0.3|||Number
727982|NCT00371436|Primary|THI (Tinnitus Handicap Inventory)|The THI (Tinnitus Handicap Inventory) is a statistically validated tinnitus questionnaire that provides an index score, ranging from 0 to 100, with higher scores reflecting greater self-perceived tinnitus handicap.|Baseline, 6 months|The THI was completed by 58 of the 92 PATM patients at both baseline and 6 months. The THI was completed by 68 of the 89 Usual Care patients at both baseline and 6 months.||scores on a scale||Standard Deviation|Mean
727983|NCT00371449|Secondary|Speech Spatial and Qualities of Hearing Scale (SSQ)|The SSQ measures hearing abilities related to speech, spatial perception, and quality of sound using a 1-10 scale. Items are averaged across the test. Higher scores indicate better outcomes.|aided (after wearing hearing aids for at least 3 months)|||units on a scale (points)||Standard Deviation|Mean
727984|NCT00371449|Secondary|Satisfaction With Amplification in Daily Life (SADL)|Measures how satisfied listeners are with their current hearing aids. Total scale scores are computed by averaging the subscale (positive effect, negative features, personal image, and service & delivery) scores that range from 1 (no satisfaction) to 7 (high satisfaction).|aided (after wearing hearing aids for at least 3 months)|||units on a scale (points)||Standard Deviation|Mean
727985|NCT00371449|Secondary|Measure of Audiologic Rehabilitation Self-Efficacy for Hearing Aids (MARS-HA)|Measures hearing-aid self-efficacy over four subscales (basic handling, advanced handling, adjustment, and aided listening). Subscale scores are averaged to produce a total self-efficacy scores that can range from 0 (low self-efficacy) to 100 (high self-efficacy).|aided (after wearing hearing aids for at least 3 months)|||% level of self-efficacy||Standard Deviation|Mean
727986|NCT00371449|Secondary|International Outcomes Inventory for Hearing Aids (IOI-HA)|Overall/general hearing-aid outcome measure. Range in scores are 7-35 with higher scores representing better outcomes.|aided (after wearing hearing aids for at least 3 months)|||units on a scale (points)||Standard Deviation|Mean
727987|NCT00371449|Secondary|Acceptable Noise Level Test|"The ANL consists of a speech signal and a competing noise signal. The speech signal is a continuous monologue (Arizona Travelogue) by a male talker and the competing noise signal is the 12-talker babble from the Speech in Noise (SPIN) test (Kalikow et al, 1977). The speech and babble stimuli are recorded on separate channels on a compact disc (CD; Cosmos, Inc.). The task of the listener was to adjust the level of the travelogue to the most comfortable level (MCL) and then to adjust the level of the babble to the level the listener is willing to put up with and still follow the travelogue, or to the background noise level (BNL). The ANL (in dB) is the difference between the MCL and BNL."|aided (after wearing hearing aids for at least 3 months)|||dB||Standard Deviation|Mean
727988|NCT00371449|Primary|Words-in-noise Test|The WIN consists of two lists of 35 Northwestern University Auditory Test No. 6 words (NU-6; Tillman and Carhart, 1966) presented in a 6-talker babble at 7 SNRs ranging from 24- to 0-dB in 4-dB decrements. Thus for each list, five unique words spoken by a female talker are presented at each SNR with the level of the babble fixed (Department of Veterans Affairs, 2006). The SNR at which the 50% point occurs is calculated with the Spearman-Kärber equation (Finney, 1952). Normal performance on the WIN is between 0 and 6-dB S/N.|aided (after wearing hearing aids for at least 3 months)|||dB S/N||Standard Deviation|Mean
727989|NCT00371462|Primary|Weight (Measured at Assessment Visits) and Pain Intensity and Pain Related Disability (NRS-I)|Study was terminated by VA. No VA outcome data to report.|baseline, 3, 6, 9, and 12 months|No data were analyzed due to termination of the study.|||||
727990|NCT00371540|Secondary|Death||12 months|||participants|||Number
727991|NCT00371540|Primary|Lost to Follow-up|Number of Subjects Lost to follow-up|12 months|||participants|||Number
727992|NCT00371540|Secondary|Viral Load|Detectable VL at 12 months|12 months|||participants|||Number
727993|NCT00371566|Secondary|Relative Change From Baseline of Kep Median (1/Min) After 2 - 4 Weeks of Treatment|DCE-MRI tracks the diffusion of an intravascularly administered contrast agent into the extravascular tissue over time. Over a period of time, the contrast agent diffuses back into the vasculature (described by the rate constant or Kep). The lower the Kep, the longer the contrast remains in the extravascular space and is more prolonged. A volume transfer (i.e, 1/min) constant of contrast agent is used to determine vascular permeability. By plugging DCE-MRI results into an appropriate pharmacokinetic model, physiological parameters of the tumor (e.g., vessel permeability, etc.) are determined.|Baseline, and Week 2 - 4|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis. DCE-MRI population||Percent change||Standard Deviation|Mean
728010|NCT00371566|Secondary|Summary of Adverse Events Experienced by 15% or More Subjects in Either Treatment Group|Definition of an adverse event is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Week 1 through 25|Safety population consisted of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.||Participants|||Number
727994|NCT00371566|Secondary|Relative Change From Baseline of Whole IAUC(90) After 2 - 4 Weeks of Treatment|Dynamic Contrast - enhanced Magnetic Resonance Imaging (DCE-MRI) tracks the diffusion of an intravascularly administered contrast agent from intravascular into the extravascular tissue over time. Initial area under the contrast (IAUC), tracks the concentration versus time curve 90 seconds after contrast injection (IAUC90). By plugging DCE-MRI results into an appropriate pharmacokinetic model, physiological parameters of the tumor microenvironment (e.g., tissue perfusion, vessel permeability, vascular surface area, and extracellular-extra vascular volume fraction) are determined.|Baseline, and Week 2 - 4|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis. DCE-MRI population||Percent change||Standard Deviation|Mean
727995|NCT00371566|Secondary|Relative Change From Baseline of Perfused IAUC (90) After 2 - 4 Weeks of Treatment|Dynamic Contrast - enhanced Magnetic Resonance Imaging (DCE-MRI) tracks the diffusion of an intravascularly administered contrast agent from intravascular into the extravascular tissue over time. Initial area under the contrast (IAUC), tracks the concentration versus time curve 90 seconds after contrast injection (IAUC90). By plugging DCE-MRI results into an appropriate pharmacokinetic model, physiological parameters of the tumor microenvironment (e.g., tissue perfusion, vessel permeability, vascular surface area, and extracellular-extra vascular volume fraction) are determined.|Baseline, and Week 2 - 4|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis. DCE-MRI population||Percent change||Standard Deviation|Mean
727996|NCT00371566|Secondary|Relative Change From Baseline of IAUC Mean (90) After 2 - 4 Weeks of Treatment|Dynamic Contrast - enhanced Magnetic Resonance Imaging (DCE-MRI) tracks the diffusion of an intravascularly administered contrast agent from intravascular into the extravascular tissue over time. Initial area under the contrast (IAUC), tracks the concentration versus time curve 90 seconds after contrast injection (IAUC90). By plugging DCE-MRI results into an appropriate pharmacokinetic model, physiological parameters of the tumor microenvironment (e.g., tissue perfusion, vessel permeability, vascular surface area, and extracellular-extra vascular volume fraction) are determined.|Baseline, and Week 2 - 4|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis. DCE-MRI population||Percent change||Standard Deviation|Mean
727997|NCT00371566|Secondary|Relative Change From Baseline of IAUC Median (90) After 2 - 4 Weeks of Treatment|Dynamic Contrast - enhanced Magnetic Resonance Imaging (DCE-MRI) tracks the diffusion of an intravascularly administered contrast agent from intravascular into the extravascular tissue over time. Initial area under the contrast (IAUC), tracks the concentration versus time curve 90 seconds after contrast injection (IAUC90). By plugging DCE-MRI results into an appropriate pharmacokinetic model, physiological parameters of the tumor microenvironment (e.g., tissue perfusion, vessel permeability, vascular surface area, and extracellular-extra vascular volume fraction) are determined.|Baseline, and Week 2 - 4|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis. DCE-MRI population||Percent change||Standard Deviation|Mean
727998|NCT00371566|Secondary|Relative Change From Baseline of Ktrans Whole (1/Min) After 2 - 4 Weeks of Treatment|Dynamic Contrast enhanced Magnetic Resonance Imaging (DCE-MRI) tracks the diffusion of an administered contrast agent from -intra into the extravascular tissue over time. Ktrans estimates blood flow and relates to the ease of exchange into extravascular spaces. A volume transfer (i.e, 1/min) constant of contrast agent is used to determine vascular permeability. By plugging DCE-MRI results into an appropriate pharmacokinetic model, physiological parameters of the tumor (e.g.,tissue perfusion, vessel permeability, vascular surface area, and extracellular/vascular volume fraction) are determined.|Baseline, and Week 2 - 4|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis. DCE-MRI population||Percent change||Standard Deviation|Mean
727999|NCT00371566|Secondary|Relative Change From Baseline of Ktrans Perfused (1/Min) After 2 - 4 Weeks of Treatment|Dynamic Contrast enhanced Magnetic Resonance Imaging (DCE-MRI) tracks the diffusion of an administered contrast agent from -intra into the extravascular tissue over time. Ktrans estimates blood flow and relates to the ease of exchange into extravascular spaces. A volume transfer (i.e, 1/min) constant of contrast agent is used to determine vascular permeability. By plugging DCE-MRI results into an appropriate pharmacokinetic model, physiological parameters of the tumor (e.g.,tissue perfusion, vessel permeability, vascular surface area, and extracellular/vascular volume fraction) are determined.|Baseline, and Week 2 - 4|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis. DCE-MRI population||Percent change||Standard Deviation|Mean
728000|NCT00371566|Secondary|Relative Change From Baseline of Ktrans Mean (1/Min) After 2 - 4 Weeks of Treatment|Dynamic Contrast enhanced Magnetic Resonance Imaging (DCE-MRI) tracks the diffusion of an administered contrast agent from -intra into the extravascular tissue over time. Ktrans estimates blood flow and relates to the ease of exchange into extravascular spaces. A volume transfer (i.e, 1/min) constant of contrast agent is used to determine vascular permeability. By plugging DCE-MRI results into an appropriate pharmacokinetic model, physiological parameters of the tumor (e.g.,tissue perfusion, vessel permeability, vascular surface area, and extracellular/vascular volume fraction) are determined.|Baseline, and Week 2 - 4|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis. DCE-MRI population||Percent change||Standard Deviation|Mean
728166|NCT00378209|Secondary|Objective Response Rate|"Response assessed by the European Group for Blood and Marrow Transplant (EBMT) criteria, modified to include nCR and VGPR from the international uniform response criteria (IMWG).
Objective response was defined by the achievement of at least Partial Response (PR) or better (CR-complete response, nCR-near complete response, and VGPR-very good partial response)."|Assessed every cycle for up to 8 cycles and best response was reported|||percentage of treated patients||90% Confidence Interval|Number
728001|NCT00371566|Secondary|Relative Change From Baseline of Kep Whole (1/Min) After 2 - 4 Weeks of Treatment|DCE-MRI tracks the diffusion of an intravascularly administered contrast agent into the extravascular tissue over time. Over a period of time, the contrast agent diffuses back into the vasculature (described by the rate constant or Kep). The lower the Kep, the longer the contrast remains in the extravascular space and is more prolonged. A volume transfer (i.e, 1/min) constant of contrast agent is used to determine vascular permeability. By plugging DCE-MRI results into an appropriate pharmacokinetic model, physiological parameters of the tumor (e.g., vessel permeability, etc.) are determined.|Baseline, and Week 2 - 4|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis. DCE-MRI population||Percent change||Standard Deviation|Mean
728002|NCT00371566|Secondary|Relative Change From Baseline of Kep Perfused (1/Min) After 2 - 4 Weeks of Treatment|DCE-MRI tracks the diffusion of an intravascularly administered contrast agent into the extravascular tissue over time. Over a period of time, the contrast agent diffuses back into the vasculature (described by the rate constant or Kep). The lower the Kep, the longer the contrast remains in the extravascular space and is more prolonged. A volume transfer (i.e, 1/min) constant of contrast agent is used to determine vascular permeability. By plugging DCE-MRI results into an appropriate pharmacokinetic model, physiological parameters of the tumor (e.g., vessel permeability, etc.) are determined.|Baseline, and Week 2 - 4|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis. DCE-MRI population||Percent change||Standard Deviation|Mean
728003|NCT00371566|Secondary|Relative Change From Baseline of Kep Mean (1/Min) After 2 - 4 Weeks of Treatment|DCE-MRI tracks the diffusion of an intravascularly administered contrast agent into the extravascular tissue over time. Over a period of time, the contrast agent diffuses back into the vasculature (described by the rate constant or Kep). The lower the Kep, the longer the contrast remains in the extravascular space and is more prolonged. A volume transfer (i.e, 1/min) constant of contrast agent is used to determine vascular permeability. By plugging DCE-MRI results into an appropriate pharmacokinetic model, physiological parameters of the tumor (e.g., vessel permeability, etc.) are determined.|Baseline, and Week 2 - 4|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis. DCE-MRI population||Percent change||Standard Deviation|Mean
728004|NCT00371566|Secondary|Relative Change From Baseline of Ktrans Median (1/Min) After 2 - 4 Weeks of Treatment|Dynamic Contrast enhanced Magnetic Resonance Imaging (DCE-MRI) tracks the diffusion of an administered contrast agent from -intra into the extravascular tissue over time. Ktrans estimates blood flow and relates to the ease of exchange into extravascular spaces. A volume transfer (i.e, 1/min) constant of contrast agent is used to determine vascular permeability. By plugging DCE-MRI results into an appropriate pharmacokinetic model, physiological parameters of the tumor (e.g.,tissue perfusion, vessel permeability, vascular surface area, and extracellular/vascular volume fraction) are determined.|Baseline, and Week 2 - 4|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis. DCE-MRI population||Percent change||Standard Deviation|Mean
728005|NCT00371566|Secondary|Adverse Events by Maximum Toxicity Grade 5 During or After Chemoradiotherapy Phase|"Events which started during or after Chemoradiotherapy Phase. Grade 5 are death related to Adverse Event."|Week 10 through 25|Safety population consisted of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.||Participants|||Number
728006|NCT00371566|Secondary|Adverse Events (AEs) by Maximum Toxicity Grade 4 During or After Chemoradiotherapy Phase|"Events which started during or after Chemoradiotherapy Phase. Grade 4 are life-threatening or disabling Adverse Event (complicated by acute, life-threatening metabolic or cardiovascular complications such as circulatory failure, hemorrhage, sepsis. Life-threatening physiologic consequences; need for intensive care or emergent invasive procedure; emergent interventional radiological procedure, therapeutic endoscopy or operation)."|Week 10 through 25|Safety population consisted of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.||Participants|||Number
728007|NCT00371566|Secondary|Adverse Events by Maximum Toxicity Grade 3 During or After Chemoradiotherapy Phase|"Events which started during or after Chemoradiotherapy Phase. Grade 3 are severe and undesirable Adverse Event (significant symptoms requiring hospitalization or invasive intervention; transfusion; elective interventional radiological procedure; therapeutic endoscopy or operation)."|Week 10 through 25|Safety population consisted of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.||Participants|||Number
728008|NCT00371566|Secondary|Summary of Serious Adverse Events During or After Chemoradiotherapy Phase|Events which started during or After Chemoradiotherapy Phase. Definition of a serious adverse event is any untoward medicinal occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other.|Week 10 through 25|Safety population consisted of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.||Participants|||Number
728009|NCT00371566|Secondary|Summary of Fatal/Serious Adverse Events During or After Chemoradiotherapy Phase|Events which started during or After the Chemoradiotherapy Phase. Definition of a serious adverse event is any untoward medicinal occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other.|Week 10 through 25|Safety population consisted of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.||Participants|||Number
729354|NCT00389805|Secondary|Number of Participants With Toxicities (Phase II)|Each adverse event will be determined by using the NCI CTCAE, Version 3.0.|Up to 36 months|The Phase II study was not conducted.|||||
728011|NCT00371566|Secondary|Comparison of Overall Response During Follow up Phase Using CT/MRI and PET Information|Position Emission Tomography (PET) scans 3-D images are read alongside CT or magnetic resonance imaging (MRI) scans, the combination gives both anatomic and metabolic information. CT = Computerized axial tomography; a type of x-ray for dense areas of the body. MRI = Magnetic Resonance Imaging which captures a picture using Magnets. Better = improvement in response, Worse = response was downgraded.|weeks 19 - 25|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis.||Participants|||Number
728012|NCT00371566|Secondary|Comparison of Overall Response During Treatment Phase Using CT/MRI and PET Information|Position Emission Tomography (PET) scans 3-D images are read alongside CT or magnetic resonance imaging (MRI) scans, the combination gives both anatomic and metabolic information. CT = Computerized axial tomography; a type of x-ray for dense areas of the body. MRI = Magnetic Resonance Imaging which captures a picture using Magnets. Better = improvement in response, Worse = response was downgraded.|Week 2 - 4|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis.||Participants|||Number
728013|NCT00371566|Secondary|Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase|Toxicity Grading scale 0=none, 1= transient symptom, 2=mild symptom that does not interfere with activities of daily living (ADL's) 3=mild but interfers with ADL's w/o hospitalization. 4=requires hopitalization 5=Death.|Week 10 through 25|The Intent-to-treat (ITT) population comprised of all subjects who were randomised to study treatment, regardless of whether they actually received study medication.||Participants|||Number
728014|NCT00371566|Secondary|Summary of Adverse Events by Maximum Toxicity Grade Started During Treatment Phase|Toxicity Grading scale 0=none, 1=transient symptom, 2=mild symptom that does not interfere with activities of daily living (ADL's) 3=mild but interfers with ADL's w/o hospitalization. 4=requires hopitalization 5=Death.|Week 1 through Week 6|The Intent-to-treat (ITT) population comprised of all subjects who were randomised to study treatment, regardless of whether they actually received study medication.||Participants|||Number
728015|NCT00371566|Secondary|Number of Biomarkers Including Tumor Protein 53 and HPV During Treatment Phase|"Tumor Suppressor p53 is welcomed and described as the guardian angel gene, it conserves stability by preventing genome mutation. Human Papillomavirus (HPV) biomarker is un-welcomed and is found to be an important precursor cancers of the head and neck. HPV biomarkers have the ability to bind to and inactivate the Tumor Suppressor p53 biomarker."|Week 2|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis.||Participants|||Number
728016|NCT00371566|Secondary|Number of Biomarkers Including ErbB1, ErbB2, pErbB1, and pErb2 at Baseline and During Treatment Phase|Estrogen Receptor (ER) variants, ERB-B2 and ERB B-5 consist of the major proportion of ER expression both in normal and cancer tissues. The exact role of these markers are unknown. Acronyms defined: ICH (immunohistochemical) and FISH (fluorescence in situ hybridization).|Baseline and Week 2|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis.||Participants|||Number
728017|NCT00371566|Secondary|Number of Participants With Circulating Tumor Cells After Chemoradiotherapy Phase in mITT Population|This measures the participants with Circulating Tumor Cells (CTC's) after chemoradiotherapy numbers of 0 to >= 4. CTC's are tumor cells that escape from the primary tumor into the bloodstream and travel through the circulation to distant sites where they develop into secondary tumors.|End of Chemoradiotherapy (week 10 - 13)|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis.||Participants|||Number
728018|NCT00371566|Secondary|Number of Participants With Circulating Tumor Cells After Treatment Phase in mITT Population|This measures the participants with Circulating Tumor Cells (CTC's) after treatment numbers of 0 to >= 4. CTC's are tumor cells that escape from the primary tumor into the bloodstream and travel through the circulation to distant sites where they develop into secondary tumors.|End of Treatment (week 2 - 6)|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis.||Participants|||Number
728019|NCT00371566|Secondary|Number of Circulating Tumor Cells at Baseline in mITT Population|This measures the participants with Circulating Tumor Cells (CTC's)Pre-Treatment numbers of 0 to >= 4. CTC's are tumor cells that escape from the primary tumor into the bloodstream and travel through the circulation to distant sites where they develop into secondary tumors.|Baseline|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis. mITT FOLLOW-UP Population of Circulation Tumor Cells||Participants|||Number
728020|NCT00371566|Secondary|Overall Radiological Response After Follow-up Phase in ITT Population|Over all: Complete Response (CR) – absence of lesions. Partial Response (PR) - CR or PR of target lesions and incomplete response (IC) or stable disease (SD) in other lesions with no new lesions or progressive disease (PD). Stable Disease (SD)– no PD or Response. Progressive Disease (PD)– PD or new lesions. Not Evaluable(NE)– no other definitions.|Baseline and End of Follow-up (week 19 - 25)|The Intent-to-treat (ITT) population comprised of all subjects who were randomised to study treatment, regardless of whether they actually received study medication.||Participants|||Number
728021|NCT00371566|Secondary|Overall Radiological Response After Treatment Phase in ITT Population|Over all: Complete Response (CR)–absence of lesions. Partial Response (PR)- CR or PR of target lesions and incomplete response (IC) or stable disease (SD) in other lesions with no new lesions or progressive disease (PD). Stable Disease (SD)–no PD or Response. Progressive Disease (PD)–PD or new lesions. Not Evaluable(NE)– no other definitions.|Baseline and End of Treatment (Week 2 - 6)|The Intent-to-treat (ITT) population comprised of all subjects who were randomised to study treatment, regardless of whether they actually received study medication.||Participants|||Number
728022|NCT00371566|Secondary|Overall Radiological Response After Follow-up Phase in mITT Population|Over all: Complete Response(CR)–absence of lesions. Partial Response(PR)- CR or PR of target lesions and incomplete response (IC) or stable disease (SD)in other lesions with no new lesions or progressive disease (PD). Stable Disease(SD)–no PD or Response. Progressive Disease(PD)–PD or new lesions. Not Evaluable(NE)– no other definitions. Number of subjects included those who were considered evaluable if they completed a full course of chemoradiotherapy and were able to provide a baseline and follow-up scan following the completion of chemoradiation.|Baseline and End of Follow-up (Week 19 - 25)|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis.||Participants|||Number
728023|NCT00371566|Secondary|Overall Radiological Response After Treatment Phase in mITT Population|Over all: Complete Response (CR)– absence of lesions. Partial Response (PR)- CR or PR of target lesions and incomplete response (IC) or stable disease (SD) in other lesions with no new lesions or progressive disease (PD). Stable Disease (SD)–no PD or Response. Progressive Disease (PD)–PD or new lesions. Not Evaluable(NE)– no other definitions. Number of subjects included those who had a scan immediately post lapatanib/placebo monotherapy.|Baseline and End of Treatment (Week 2 - 6)|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis.||Participants|||Number
728024|NCT00371566|Secondary|Change From Baseline of Cell Proliferation Rate of the Ki-67 Proliferative Index in Tumour Biopsy Samples During Treatment Phase|The Ki-67 protein is expressed in all phases of the cell cycle except G0 (low level phase) and serves as a good marker for cell proliferation. Scoring is assessed by point counting 500 to 1000 cells, and is reported as percent positive cells. 20% positive cells to define “positive” (i.e. high risk)|Baseline and Week 2|The mITT (modified Intent-to-Treat) population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumor biopsy sample for the primary endpoint analysis.||Percent of positive cells||Standard Deviation|Mean
728025|NCT00371566|Primary|Change From Baseline of the Apoptotic Index During Treatment Phase|Apoptotic Index-TUNEL Assay is a method which counts a total of at least 1000 neoplastic nuclei(Cells with morphological changes defining cell death) subdivided in 10 fields chosen randomly at 400x magnification. A ‘responder’ was defined as having 20% cell death.|Baseline and Week 2|The Intent-to-treat (ITT) population comprised of all subjects who were randomised to study treatment, regardless of whether they actually received study medication.||Percentage of positive cells||Standard Deviation|Mean
728026|NCT00371631|Secondary|The Rate of Symptomatic UTI While Colonized|Symptomatic UTI was defined as significant bacteriuria (≥105 cfu/ml) and pyuria (>10 WBC/hpf) plus ≥1 of the following signs and symptoms for which no other etiology could be identified: fever (oral temperature >100°F), suprapubic or flank discomfort, bladder spasm, change in voiding habits, increased spasticity, or worsening dysreflexia. The rate of UTI (number) was calculated by dividing the total number of patient days by the total number of UTIs.|3 years|||UTI/per subject year|||Number
728027|NCT00371631|Primary|Bladder Colonization|Bladder colonization was defined when (≥102 cfu/ml) of E. coli 83972 was detected in urine cultures for > 3 days after catheter removal.|> 3 days, up to 197 days|||percentage of participants|||Number
728028|NCT00371644|Primary|PTSD Checklist (PCL)|The PCL is a 17-item self-report measure that is commonly used in clinical and research settings. All 17 items are summed to compute a total score of PTSD symptomatology. Scores for the PCL range from 17-85, with 85 indicating severe PTSD symptomatology. The PCL has strong psychometric properties and mirrors the symptomatology of the DSM.|Baseline assessment and then 4, follow-up assessments: at treatment completion, 2-month post treatment, 4-month post treatment, and 6-month post treatment|Numbers differ from enrollment due to participants excluded from data analysis for poor psychotherapeutic fidelity.||units on a scale||Standard Error|Mean
728029|NCT00371683|Secondary|Number of Participants With Other Chemistry Laboratory Marked Abnormalities During the Treatment Period|Treatment Period=the period from first dose of study drug through 2 days after discontinuation of study drug. Laboratory Chemistry profile was measured during screening (pre-operative, post-operative) and in the Treatment Period on Days 4, and 12 (end of treatment). Fasting Glucose: if pre-dose < LLN then use < 0.8*predose; or > ULN if pre-dose > ULN then use > 2.0*predose or <LLN. Total Protein: < 0.9*LLN or > 1.1*ULN, or if pre-dose < LLN then use 0.9*predose or > ULN if pre-dose > ULN then use 1.1*predose or < LLN. Uric Acid: > 1.5*ULN, or if pre-dose > ULN then use > 2*predose. Creatine Kinase (CK): > 5*ULN.|First dose to last dose of study drug (12 days), plus 2 days|All participants who received at least one dose of study drug and had available laboratory results for that analyte and treatment group.||participants|||Number
728030|NCT00371683|Secondary|Number of Participants With Electrolyte Chemistry Laboratory Marked Abnormalities During the Treatment Period|Laboratory Chemistry profile was measured during screening (pre-operative, post-operative) and in the Treatment Period on Days 4, and 12 (end of treatment). Potassium: < 0.9*LLN or > 1.1*ULN, or if pre-dose < LLN then use < 0.9*predose or > ULN if pre-dose > ULN then use > 1.1*predose or < LLN. Calcium: < 0.8*LLN or > 1.2*ULN, or if pre-dose < LLN then use < 0.75*predose or > ULN If pre-dose > ULN then use > 1.25*predose or < LLN. Chloride: < 0.9*LLN or > 1.1*ULN, or if pre-dose < LLN then use < 0.9*predose or > ULN if pre-dose > ULN then use > 1.1*predose or < LLN. Sodium: < 0.95*LLN or > 1.05*ULN, or if pre-dose < LLN then use < 0.95*predose or >ULN if pre-dose > ULN then use > 1.05*predose or < LLN. Bicarbonate: < 0.75*LLN or > 1.25*ULN, or if pre-dose < LLN then use < 0.75*predose or > ULN if pre-dose > ULN then use > 1.25*predose or < LLN.|First dose to last dose of study drug (12 days), plus 2 days|All participants who received at least one dose of study drug and had available laboratory results for that analyte and treatment group.||participants|||Number
728040|NCT00371683|Secondary|Event Rate for Participants With Proximal DVT, Distal DVT, Asymptomatic Proximal DVT, Asymptomatic Distal DVT With Onset During the Intended Treatment Period|ICAC adjudicated all venograms and suspected symptomatic DVT. Event rate was number of participants with the endpoint divided by the number of participant’s analyzed (%).|From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization|Randomized participants with either an adjudicated and evaluable bilateral proximal (or distal, as appropriate) venogram or an adjudicated event associated with the endpoint. n= number analyzed||percentage of participants||95% Confidence Interval|Number
728031|NCT00371683|Secondary|Number of Participants With Liver and Kidney Function Chemistry Laboratory Marked Abnormalities During the Treatment Period|Treatment Period=the period from first dose of study drug through 2 days after discontinuation of study drug. Laboratory Chemistry profile was measured during screening (pre-operative, post-operative) and in the Treatment Period on Days 4, and 12 (end of treatment). Bilirubin (direct) high: > 1.5*ULN. Total bilirubin: : > 2*ULN, Alanine Aminotransferase (ALT) high: > 3*ULN. Alkaline Phosphatase (ALP): > 2*ULN. Aspartate Aminotransferase (AST): > 3*ULN. Creatinine: > 1.5*ULN.|First dose to last dose of study drug (12 days), plus 2 days|All participants who received at least one dose of study drug and had available laboratory results for that analyte and treatment group.||participants|||Number
728032|NCT00371683|Secondary|Number of Participants With Hematology Laboratory Marked Abnormality During the Treatment Period|Treatment Period=the period from first dose of study drug through 2 days after discontinuation of study drug. Hematology profile was measured during screening (pre-operative, post-operative) and in the Treatment Period on Days 2, 3, 4, 12 (end of treatment). Upper limit of normal (ULN); lower limit of normal (LLN). Platelet Count low: < 100,000/mm^3 (or < 100*109 cells/L). Erythrocytes low: < 0.75 *pre-dose. Hemoglobin low: > 2 g/dL decrease compared to pre-dose or Value ≤ 8 g/dL. Hematocrit low: < 0.75*pre-dose . Leukocytes: < 0.75*LLN or > 1.25* ULN, or if pre-dose < LLN then use < 0.8*predose or > ULN if pre-dose > ULN then use > 1.2*predose or < LLN. Lymphocytes (absolute): < 0.750*10^3 cells/µL or > 7.50*10^3 cells/ µL. Eosinophils (absolute) high: > 0.750*10^3 cells/µL. Basophils(absolute) high: > 400/mm^3 (or > 0.4*103 cells/µL). Monocytes (absolute) high: > 2000/mm^3 (or > 2*103 cells/µL). Neutrophils(absolute) high: < 1.0*103 cells/µL.|First dose to last dose of study drug (12 days), plus 2 days|All participants who received at least one dose of study drug and had available laboratory results for that analyte and treatment group.||participants|||Number
728033|NCT00371683|Secondary|Mean Change From Baseline in Heart Rate During the Treatment Period|Treatment Period=the period from first dose of study drug through 2 days after discontinuation of study drug (12 + 2 days). Baseline=measurement prior to first dose of study drug. Heart rate was measured during screening (pre-operative, post-operative) and in the treatment period on Days 1 (day of first dose), 2, 3, 4,12 (end of treatment). Heart rate was measured in beats per minute (bpm).|Baseline to last dose of study drug, plus 2 days|All participants who received at least one dose of study drug and had heart rate measurements at baseline were summarized.||bpm||Standard Error|Mean
728034|NCT00371683|Secondary|Mean Change From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period|Treatment Period=the period from first dose of study drug through 2 days after discontinuation of study drug (12 + 2 days). Baseline=measurement prior to first dose of study drug. Blood pressures (BP) were measured during screening (pre-operative, post-operative) and in the treatment period on Days 1 (day of first dose), 2, 3, 4,12 (end of treatment). Systolic and diastolic pressures were measured in millimeters of mercury (mmHg).|Baseline to last dose of study drug, plus 2 days|All participants who received at least one dose of study drug and had blood pressure measurements at baseline were summarized.||mmHg||Standard Error|Mean
728035|NCT00371683|Secondary|Number of Participants With Serious Adverse Events (SAEs), Bleeding Adverse Events (AEs), AEs Leading to Discontinuation, and Deaths - Treated Population|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|First dose to last dose, plus 2 days for AEs (12 + 2 days) or plus 30 days for SAEs (12 + 30 days)|All participants who received at least 1 dose of study drug during the Treatment Period.||participants|||Number
728036|NCT00371683|Secondary|Event Rate of Adjudicated MI, Stroke, and Thrombocytopenia Events During the Follow-Up Period|A 60-day follow-up period started after the last dose of study drug and continued until the End of Study Visit on Day 72 (60 days ± 3 days, after the last dose of study drug). Event rate was number of participants with the endpoint divided by the number of participants analyzed (%). ICAC adjudicated acute clinically overt bleeding events, suspected thrombocytopenia, suspected acute MI, suspected acute stroke per ISTH guidelines modified for surgical patients.|Post last dose of study drug to Day 72 (60 days)|Participants who received at least one dose of study drug and entered the Follow-Up period||percentage of participants||95% Confidence Interval|Number
728037|NCT00371683|Primary|Event Rate for Participants With Major Bleeding, Clinically Relevant (CR) Non-Major (N-M) Bleeding , Major or Clinically Relevant (CR) Non-Major (N-M) Bleeding, Any Bleeding With Onset During the Follow-Up Period|ICAC adjudicated acute clinically overt bleeding events as per International Society on Thrombosis and Hemostasis (ISTH) guidelines modified for surgical patients. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed (%). Follow up Period was from the end of the treatment period (last dose) up to 60 days post last dose, Day 72.|Last dose of study drug to Day 72 (60 days)|All participants who received at least 1 dose of study drug during the Treatment Period and entered the Follow-Up Period.||percentage of participants||95% Confidence Interval|Number
728038|NCT00371683|Primary|Event Rate for Participants With Major Bleeding, Clinically Relevant Non-Major Bleeding, Major or Clinically Relevant Non-Major Bleeding, Any Bleeding With Onset During the Treatment Period - Treated Population|ICAC adjudicated acute clinically overt bleeding events as per International Society on Thrombosis and Hemostasis (ISTH) guidelines modified for surgical patients. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed (%). Clinically relevant (CR); Non-Major (N-M) Bleeding. Day 1=Day of surgery. Treatment started (first dose) day of surgery or next day. Treatment continued for 12 days.|First dose of study drug to last dose, plus 2 days post last dose|All participants who received at least one dose of study drug (Treated population).||percentage of participants||95% Confidence Interval|Number
728039|NCT00371683|Secondary|Event Rate for Participants With Adjudicated Myocardial Infarction (MI) Acute Ischemic Stroke and Thromboembolic Events With Onset During the Treatment Period|ICAC adjudicated acute clinically overt bleeding events, suspected thrombocytopenia, suspected acute MI, suspected acute stroke per International Society on Thrombosis and Hemostasis (ISTH) guidelines modified for surgical patients. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed (%).|From first dose to last dose, plus 2 days (12 days, plus 2)|All participants who received at least one dose of study drug were analyzed (Treated Population).||percentage of participants||95% Confidence Interval|Number
728041|NCT00371683|Secondary|Event Rate for Participants With PE (Fatal or Non-Fatal), DVT (All, Symptomatic Proximal, and Distal, Asymptomatic) With Onset During the Intended Treatment Period|An ICAC adjudicated all venograms, suspected symptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE), acute clinically overt bleeding events, suspected thrombocytopenia, suspected acute MI, suspected acute stroke, and cause of death. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed (%).|From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization|All randomized participants: PE, Symptomatic DVT, Symptomatic Proximal DVT, Symptomatic Distal DVT. Randomized with an adjudicated and evaluable bilateral venogram or an adjudicated event associated with the endpoint: All DVT, Asymptomatic DVT. n=number analyzed in each category||percentage of participants||95% Confidence Interval|Number
728042|NCT00371683|Secondary|Event Rate for Participants With VTE/Major Bleeding/All-Cause Death With Onset During the Intended Treatment Period|ICAC adjudicated VTE, acute clinically overt bleeding events, suspected thrombocytopenia, and cause of death. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed (%).|From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization|Randomized participants with an adjudicated and evaluable bilateral venogram or an adjudicated event associated with the endpoint, during the Intended Treatment Period, were analyzed.||percentage of participants||95% Confidence Interval|Number
728043|NCT00371683|Secondary|Event Rate for Participants With Symptomatic VTE/ VTE-Related Death With Onset During the Intended Treatment Period|ICAC adjudicated suspected symptomatic DVT and PE, and cause of death. Event rate was number of participants with the endpoint divided by the number of participant’s analyzed (%).|From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization|All randomized participants were analyzed.||percentage of participants||95% Confidence Interval|Number
728044|NCT00371683|Secondary|Event Rate for Participants With Symptomatic VTE/ All-Cause Death With Onset During the Intended Treatment Period|ICAC adjudicated suspected symptomatic DVT and PE, and cause of death. Event rate was number of participants with the endpoint divided by the number of participant’s analyzed (%).|From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization|All randomized participants were analyzed.||percentage of participants||95% Confidence Interval|Number
728045|NCT00371683|Secondary|Event Rate for Participants With VTE-Related Death With Onset During the Intended Treatment Period|ICAC adjudicated cause of death. Event rate was number of participants with the endpoint divided by the number of participant’s analyzed (%).|From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization|All randomized participants were analyzed.||percentage of participants||95% Confidence Interval|Number
728046|NCT00371683|Secondary|Event Rate for Participants With All-Cause Death During the Intended Treatment Period|Event rate was number of participants with all-cause death divided by the number of participant’s analyzed (%).|From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization|All Randomized participants were analyzed.||percentage of participants||95% Confidence Interval|Number
728047|NCT00371683|Secondary|Event Rate for Total Participants With VTE/ VTE-Related Death With Onset During the Intended Treatment Period|ICAC adjudicated all venograms, suspected symptomatic DVT and PE, and cause of death. VTE includes DVT and PE. Event rate was number of participants with the endpoint divided by the number of participant’s analyzed (%).|From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization|Randomized participants with either an adjudicated and evaluable bilateral proximal venogram or an adjudicated event associated with the endpoint, during the Intended Treatment Period, were analyzed.||percentage of participants||95% Confidence Interval|Number
728048|NCT00371683|Secondary|Event Rate for Total Participants With Adjudicated VTE/All-Cause Death With Onset During the Intended Treatment Period|ICAC adjudicated all venograms, suspected symptomatic DVT and PE, and cause of death. Event rate was number of participants with the endpoint divided by the number of participant’s analyzed (%).|From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization|Randomized participants with either an adjudicated and evaluable bilateral proximal venogram or an adjudicated event associated with the endpoint, during the Intended Treatment Period, were analyzed.||percentage of participants||95% Confidence Interval|Number
728049|NCT00371683|Secondary|Event Rate for Participants With Proximal DVT/Non-Fatal PE/ VTE-Related Death With Onset During the Intended Treatment Period|An ICAC adjudicated all venograms, suspected symptomatic DVT and PE, and cause of death. Event rate was number of participants with the endpoint divided by the number of participant’s analyzed (%).|From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization|Randomized participants with either an adjudicated and evaluable bilateral proximal venogram or an adjudicated event associated with the endpoint, during the Intended Treatment Period, were analyzed.||percentage of participants||95% Confidence Interval|Number
728050|NCT00371683|Secondary|Event Rate of Adjudicated VTE / VTE-related Death With Onset During the Treatment Period|VTE / VTE-related death was defined as the combination of fatal or non-fatal PE, and symptomatic or asymptomatic DVT. A mandatory bilateral ascending contrast venogram was performed on all participants after 12 days (±2 days) of study treatment. An ICAC adjudicated all venograms, suspected symptomatic DVT and PE, and cause of death. Event rate was number of participants with the endpoint divided by the number of participant’s analyzed (%).|From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization|Randomized participants with an adjudicated and evaluable bilateral venogram or an adjudicated event associated with the endpoint, during the Intended Treatment Period, were analyzed.||percentage of participants||95% Confidence Interval|Number
728051|NCT00371683|Secondary|Event Rate of Composite of Adjudicated Proximal DVT, Non-Fatal PE and All-Cause Death With Onset During the Intended Treatment Period PE and All-cause Death During the Intended Treatment Period|A mandatory bilateral ascending contrast venogram was performed on all participants after 12 days (±2 days) of study treatment. An ICAC adjudicated all venograms, suspected proximal DVT and non-fatal PE, and all-cause of death. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed and reported as percentage (%).|From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization|Randomized participants with either an adjudicated and evaluable bilateral proximal venogram or an adjudicated non-fatal PE or death, during the Intended Treatment Period, were analyzed.||percentage of participants||95% Confidence Interval|Number
728260|NCT00379587|Secondary|Incidence of Adverse Hematological Events|White blood cell decrease, neutrophil cell count decrease, or platelet cell decrease considered possibly or probably related to therapy with rituximab.|by 18 months after peripheral blood stem (PBSC) infusion|||participants|||Number
728052|NCT00371683|Primary|Event Rate of the Composite of Adjudicated Venous Thromboembolism (VTE) Events and All-Cause Death With Onset During the Intended Treatment Period - Primary Subjects|An Independent Central Adjudication Committee (ICAC) adjudicated all venograms, suspected symptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE), acute clinically overt bleeding events, suspected thrombocytopenia, suspected acute MI, suspected acute stroke, and cause of death. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed and reported as percentage (%). Surgery=Day 1; Randomization/Treatment started on Day of Surgery or the next day (Day 1 or Day 2). A mandatory bilateral ascending contrast venogram was performed on all participants after 12 days (±2 days) of study treatment. Intended Treatment Period=starts on the day of randomization; for treated participants, the period ends at the latter of 2 days after last dose of study drug or 14 days after the first dose of study drug; for randomized participants who were not treated, the period ends 14 days after randomization.|From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization|Primary Population=All randomized participants who: have an adjudicated and evaluable bilateral venogram performed during the Intended Treatment Period; or have an adjudicated VTE during the Intended Treatment Period; or die due to any cause during the Intended Treatment Period.||percentage of participants||95% Confidence Interval|Number
728053|NCT00371761|Primary|Number of Participants With a Combined Response Consisting of All Three Responses - (a) Serological Response, (b) Virological Response, and (c) Biochemical Response|"Serological response is defined as Loss of HBeAg (Hepatitis B e antigen) and Appearance of anti-HBe (Hepatitis B e antibodies); participant is HBeAg negative and anti-HBe positive.
Virological response was defined as having < 10^5 copies/mL of serum HBV DNA (Hepatitis B Virus Deoxyribonucleic Acid) by real-time PCR (Polymerase Chain Reaction).
Biochemical response was defined as acheiving normal levels of ALT (Alanine Aminotransferase) level in Units/L."|At Week 72 [for Pegylated interferon alfa-2b (PegIntron), at 48 weeks post PegIntron treatment for up to 24 weeks; for Adefovir, at 24 weeks post adefovir treatment for up to 48 weeks]|||Participants|||Number
728054|NCT00371787|Primary|Neovascularization|length of the blood vessels entering the superior cornea, higher number means longer blood vessel penetration.|9 month|||mm||Standard Deviation|Mean
728055|NCT00371787|Primary|Neovascularisation|length of the blood vessels entering the superior cornea, higher number means longer blood vessel penetration.|baseline|||mm||Standard Deviation|Mean
728056|NCT00371787|Primary|Visual Acuity|level of vision measured using high contrast acuity chart, higher (more positive)logMAR indicates worse vision.|9 month|||logMAR||Standard Deviation|Mean
728057|NCT00371787|Primary|Visual Acuity|level of vision measured using high contrast acuity chart, higher (more positive)logMAR indicates worse vision.|baseline|Per Protocol. Only the data from participants who completed all study visits were analyzed.||logMAR||Standard Deviation|Mean
728058|NCT00371826|Secondary|Change in Bone Mineral Density Between Week 2 and Month 24 (36 Months Analysis)|Measurements of bone mineral density (BMD) by Dual Energy X-ray Absorptiometry (DEXA) were done at Week 2 and Month 24. Change in BMD between week 2 and Month 24 were done for neck of femur and lumbar spine.|Week 2, Month 24|Safety population extension (SAF-EX): All patients who entered the extension period, who were treated with at least one dose of study medication during the extension period and had at least one safety/tolerability assessment after entering the extension period. Patients with week 2 and month 24 assessment for this analysis were included.||g/cm^2||Standard Deviation|Mean
728059|NCT00371826|Secondary|Number of Patient Survival and Graft Survival (36 Months Analysis)||At Month 12, 24 and 36|Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period. This population includes also all patients who were randomized but were not treated with study medication.||Participants|||Number
728060|NCT00371826|Secondary|Number of Patient Survival and Graft Survival (12 Months Analysis)||At Month 12|Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication.||Participants|||Number
728061|NCT00371826|Secondary|Number of Participants With Biopsy Proven Acute Rejection (BPAR) Influenced by Demographic Characteristics and Morbidities (36 Months Analysis)|The influence of demographic characteristics and comorbidities on incidence of BPAR were analyzed in the following way: Demographic characteristics were age (<55 years, ≥55 years), Expanded Criteria Donor [ECD] organ (donor age >60 years or donor non heart-beating and donor age >50), gender, living vs. deceased donor, Body Mass Index (BMI) classes (underweight <18.5, normal 18.5 - <25.0, overweight 25.0 - <30.0, obesity 30.0 and above), years on dialysis before transplantation (<1, 1-5, >5 years). Comorbidities were diabetes, hypertension, cardiovascular diseases/events, nephrosclerosis, glomerulonephritis/glomerular disease, polycystic disease, and Cytomegalovirus status.|At Month 36|Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period. This population includes also all patients who were randomized but were not treated with study medication||Participants|||Number
728062|NCT00371826|Secondary|Number of Participants With Biopsy Proven Acute Rejection (BPAR) Influenced by Demographic Characteristics and Morbidities (12 Months Analysis)|The influence of demographic characteristics and comorbidities on incidence of BPAR were analyzed in the following way: Demographic characteristics were age (<55 years, ≥55 years), Expanded criteria Donor (ECD) organ (donor age >60 years or donor non heart-beating and donor age >50), gender, living vs. deceased donor, Body Mass Index (BMI) classes (underweight <18.5, normal 18.5 - <25.0, overweight 25.0 - <30.0, obesity 30.0 and above), years on dialysis before transplantation (<1, 1-5, >5 years). Comorbidities were diabetes, hypertension, cardiovascular diseases/events, nephrosclerosis, glomerulonephritis/glomerular disease, polycystic disease, and Cytomegalovirus status.|At Month 12|Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication.||Participants|||Number
728063|NCT00371826|Secondary|Number of Participants With Antibody-mediated Rejection Per Treatment Group (36 Months Analysis)||At Month 12, 24 and 36|Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period. This population includes also all patients who were randomized but were not treated with study medication.||Participants|||Number
728065|NCT00371826|Secondary|Number of Participants With Notable Abnormalities in Total Cholesterol and Triglycerides as Measurement of Effect of Treatment on Cardiovascular Health (36 Months Analysis)|"Notable abnormal total cholesterol is defined as : High: >= 9.1 mmol/L , normal range is 0.00 - 5.17 mmol/L
Notable abnormal triglycerides is defined as : High: >= 8.5 mmol/L, normal range is 0.30 - 2.00 mmol/L"|Overall Post Baseline up to month 36|Safety population extension (SAF-EX): All patients who entered the extension period, treated with at least one dose of study medication during the extension period and had at least one safety/tolerability assessment after entering the extension period. Patients with serum lipid assessment anytime post baseline up to 36 month were included .||Participants|||Number
728066|NCT00371826|Secondary|Number of Participants With Notable Abnormalities in Total Cholesterol and Triglycerides as Measurement of Effect of Treatment on Cardiovascular Health (12 Months Analysis)|"Notable abnormal total cholesterol is defined as : High: >= 9.1 mmol/L , normal range is 0.00 - 5.17 mmol/L
Notable abnormal triglycerides is defined as : High: >= 8.5 mmol/L, normal range is 0.30 - 2.00 mmol/L"|Overall post baseline up to month 12|Safety population (SAF): All patients in whom transplantation was performed and who were treated with at least one dose of study medication and had at least one safety/tolerability assessment after randomization. Patients with serum lipid assessment anytime post baseline up to 12 month were included in this analysis.||Participants|||Number
728067|NCT00371826|Secondary|Number of Participants With Any Wound Problems (36 Months Analysis)|Patients with any wound healing problem such as infection related to kidney surgery, dehiscence, lymphocele, hernia, seroma, hematoma, ureteral anastomotic complication and other were reported in this analysis.|At Month 12, 24 and 36|Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period.||Participants|||Number
728068|NCT00371826|Secondary|Number of Participants With Wound Problems(12 Months Analysis)|Patients with any wound healing problem such as infection related to kidney surgery, dehiscence, lymphocele, hernia, seroma, hematoma, ureteral anastomotic complication and other were reported in this analysis.|At Month 12|Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication.||Participants|||Number
728069|NCT00371826|Secondary|Number of Participants With Employment Status (36 Months Analysis)|"The various employment status reported are:
Employed/self employed full time
Employed part time
Unemployed
Homemaker
Volunteer
Permanently disabled
Non-permanently disable
Retired
Other"|At screening (at day 0 +/- 7 days ), At Month 36|Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period. This population includes also all patients who were randomized but were not treated with study medication.||Participants|||Number
728070|NCT00371826|Secondary|Number of Participants With Employment Status (12 Months Analysis)|"The various employment status reported are:
Employed/self employed full time
Employed part time
Unemployed
Homemaker
Volunteer
Permanently disabled
Non-permanently disable
Retired
Other"|At screening (at day 0 +/- 7 days ), At Month 12|Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication.||Participants|||Number
728071|NCT00371826|Secondary|Number of Participants Hospitalized for Reasons Other Than Primary Transplantation (36 Months Analysis)|This analysis is reporting number of participants hospitalized for reasons (such as acute rejection, infection, gastrointestinal (GI) events, cardiovascular event, metabolic disorder and Other) other than primary transplantation.|Month 36|Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period.||Participants|||Number
728072|NCT00371826|Secondary|Number of Participants Hospitalized for Reasons Other Than Primary Transplantation (12 Months Analysis)|This analysis is reporting number of participants hospitalized for reasons (such as acute rejection, infection, gastrointestinal (GI) events, cardiovascular event, metabolic disorder and Other) other than primary transplantation.|Month 12|Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication.||Participants|||Number
728073|NCT00371826|Secondary|Mean Short-form 36 Health Survey (SF-36) Score as a Measure of Quality of Life Assessment (36 Months Analysis)|"SF-36 measures impact of disease on overall quality of life (QoL). 36-item survey has 8 subscales. The 8 subscales are : Physical functioning (PF), Role-physical (RP), Bodily pain (BP), General health (GH), Vitality (VT), Social functioning (SF), Role-emotional (RE) and Mental health (MH).
Score for each sub-scale has been standardized with the use of norm-based methods based on assessment of the general U.S. population free of chronic conditions. Scores range from 1-100 with a mean=50 and a standard deviation=10. A higher score indicates less impact on QoL."|At Month 24|Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period. This also includes patients who were randomized but were not treated with study drug. Patients with completed SF-36 assessment were included in this analysis.||units on a scale||Standard Deviation|Mean
728074|NCT00371826|Secondary|Mean Short-form 36 Health Survey (SF-36) Score as a Measure of Quality of Life Assessment (12 Months Analysis)|"SF-36 measures impact of disease on overall quality of life (QoL). 36-item survey has 8 subscales. The 8 subscales are: Physical functioning (PF), Role-physical (RP), Bodily pain (BP), General health (GH), Vitality (VT), Social functioning (SF), Role-emotional (RE) and Mental health (MH).
Score for eash sub-scale has been standardized with the use of norm-based methods based on assessment of the general U.S. population free of chronic conditions. Scores range from 1-100 with a mean=50 and a standard deviation=10. A higher score indicates less impact on QoL."|At Month 12|Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication. Only those patients who had completed the QoL assessment for Month 12 were included in this analysis.||units on a scale||Standard Deviation|Mean
728075|NCT00371826|Secondary|Number of Participants With Erythropoietin Usage (36 Months Analysis)||Month 36|Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period. This also includes patients who were randomized but were not treated with study drug.||participants|||Number
728077|NCT00371826|Secondary|Number of Participants With Notable Abnormal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as Measurement of Effect of Treatment on Cardiovascular Health (36 Months Analysis)|"Notable abnormal systolic blood pressure is defined as :
Either an increase of >=30 that results in >=180 or >200 (mm/Hg)
OR a decrease of >=30 that results in <=90 or <75 (mm/Hg) from baseline
Notable abnormal diastolic blood pressure is defined as :
Either an increase of >=20 that results in >=105 or >115 (mm/Hg)
OR a decrease of >=20 that results in <=50 or <40 (mm/Hg) from baseline"|Baseline, Overall post baseline up to Month 36|Safety population extension (SAF-EX): All patients who entered the extension period, treated with at least one dose of study medication during the extension period and had at least one safety/tolerability assessment after entering the extension period. Patients with baseline and overall post baseline up to month 36 assessment were included.||Participants|||Number
728078|NCT00371826|Secondary|Number of Participants With Notable Abnormal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as Measurement of Effect of Treatment on Cardiovascular Health (12 Months Analysis)|"Notable abnormal systolic blood pressure is defined as :
Either an increase of >=30 that results in >=180 or >200 (mm/Hg)
OR a decrease of >=30 that results in <=90 or <75 (mm/Hg)from baseline
Notable abnormal diastolic blood pressure is defined as :
Either an increase of >=20 that results in >=105 or >115 (mm/Hg)
OR a decrease of >=20 that results in <=50 or <40 (mm/Hg) from baseline"|Baseline, Overall post-baseline up to 12 month|Safety population (SAF): All patients in whom transplantation was performed and who were treated with at least one dose of study medication and had at least one safety/tolerability assessment after randomization. Patients with baseline and overall post baseline up to 12 month assessment for this analysis were included.||Participants|||Number
728079|NCT00371826|Secondary|Number of Participants With New Onset Diabetes Mellitus After Transplantation (NODAT) and Impaired Fasting Glucose (36 Months Analysis)|"The symptoms of new onset diabetes mellitus after transplantation (NODAT) and impaired fasting glucose are defined as any of the following conditions:
Patients receiving glucose lowering treatment
2 fasting plasma glucose (FPG) values >= 126 mg/dL or 2 random plasma glucose (RPG) values >= 200 mg/dL or FPG value >= 126 mg/dL and 1 RPG value >= 200 mg/dL
Diabetes reported as treatment emergent AE with end date > Day 15"|At Month 36|Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period. This also includes patients who were randomized but were not treated with study drug.||Participants|||Number
728080|NCT00371826|Secondary|Number of Participants With Post Transplant Diabetes Mellitus (PTDM) and Impaired Fasting Glucose (12 Months Analysis)|"The symptoms of post transplant diabetes mellitus (PTDM) and impaired fasting glucose are defined as any of the following conditions:
Patients receiving glucose lowering treatment
Fasting plasma glucose (FPG) >= 126 mg/dL on 2 separate occasions
Hemoglobin subtype A1c (HbA1c) > 6.5%
Diabetes reported as treatment emergent AE with end date > Day 15"|At Month 12|Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication. Patients with 12 month data on PTDM were included in this analysis.||Participants|||Number
728081|NCT00371826|Secondary|Mean Urine Albumin/Creatinine Ratio [ACR] as Measurement of Proteinuria (36 Months Analysis)|Proteinuria is measured by spot morning urine Albumin/Creatinine Ratio [ACR]. When the ACR is more than or equal to 30 mg/mmol then it is known as proteinuria.|At Month 12, 18, 24 and 36|Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment in extension period. This also includes all patients who were randomized but were not treated with study medication. Patients with ACR data at particular time point were included for analysis.||mg/mmol||Standard Deviation|Mean
728082|NCT00371826|Secondary|Mean Urine Albumin/Creatinine Ratio (ACR) as Measurement of Proteinuria (12 Months Analysis)|Proteinuria is measured by spot morning urine Albumin/Creatinine Ratio [ACR]. When the ACR is more than or equal to 30 mg/mmol then it is known as proteinuria.|At Month 12|Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication. Patients with 12 month data on Proteinuria were included in this analysis.||mg/mg||Standard Deviation|Mean
728083|NCT00371826|Secondary|Creatinine Clearance Calculated by the Cockcroft-Gault Formula (36 Months Analysis)|"Creatinine clearance were calculated according to the Cockcroft-Gault formula:
CrCl (males) = (140-A) × BW/(72 × Cr) CrCl (females) = CrCl (males) × 0.85 where A is age [years], BW is body weight [kg], and Cr is the serum concentration of creatinine [mg/dL].
The Cockcroft-Gault formula estimates creatinine clearance based on serum creatinine level, body weight, and age."|At Month 12, 24 and 36|Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period. Patients with data on creatinine clearance were included in this analysis. Last observation carried forward (LOCF) imputation technique was used.||mL/min||Standard Deviation|Mean
728084|NCT00371826|Secondary|Creatinine Clearance (CrCl) Calculated by the Cockcroft-Gault Formula (12 Months Analysis)|"Creatinine clearance were calculated according to the Cockcroft-Gault formula:
CrCl (males) = (140-A) × BW/(72 × Cr) CrCl (females) = CrCl (males) × 0.85 where A is age [years], BW is body weight [kg], and Cr is the serum concentration of creatinine [mg/dL].
The Cockcroft-Gault formula estimates creatinine clearance based on serum creatinine level, body weight, and age."|At Month 12|Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication. Patients with 12 month data on creatinine clearance were included in this analysis.||mL/min||Standard Deviation|Mean
728085|NCT00371826|Secondary|Mean Serum Creatinine (36 Months Analysis)||At Month 12, 18, 24 and 36|Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period. Patients with data on creatinine serum creatinine were included in this analysis. Last observation carried forward (LOCF) imputation technique was used.||umol/L||Standard Deviation|Mean
728086|NCT00371826|Secondary|Mean Serum Creatinine (12 Months Analysis)||At Month 12|Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication. Patients with 12 month data on serum creatinine were included in this analysis.||umol/L||Standard Deviation|Mean
728261|NCT00379587|Secondary|Incidence of Relapse or Progression of Disease|Percentage of participants with relapsed disease by year 4 post transplant.|by 4 years after peripheral blood stem cell (PBSC) infusion|||percentage of participants|||Number
728087|NCT00371826|Secondary|Number of Participants With Sub Clinical Acute Rejection (36 Months Analysis)|"Based on Banff 97 criteria, sub clinical acute rejection can be:
GRADE IA - Cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (>4 mononuclear cells/tubular cross section or group of 10 tubular cells).
GRADE IB - Cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (>10 mononuclear cells/tubular cross section or group of 10 tubular cells).
GRADE IIA - Cases with significant interstitial infiltration and mild to moderate intimal arteritis (v1).
GRADE IIB - Cases with moderate to severe intimal arteritis comprising >25% of the luminal area (v2).
GRADE III - Cases with transmural arteritis or fibrinoid change and necrosis of medial smooth muscle cells (v3).
Borderline' category is used when no intimal arteritis is present, but there are foci of mild tubulitis (1 to 4 mononuclear cells/tubular cross section)."|At Month 36|Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period.||Participants|||Number
728088|NCT00371826|Secondary|Number of Participants With Sub Clinical Acute Rejection (12 Months Analysis)|"Based on Banff 97 criteria, sub clinical acute rejection can be:
GRADE IA - Cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (>4 mononuclear cells/tubular cross section or group of 10 tubular cells).
GRADE IB - Cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (>10 mononuclear cells/tubular cross section or group of 10 tubular cells).
GRADE IIA - Cases with significant interstitial infiltration and mild to moderate intimal arteritis (v1).
GRADE IIB - Cases with moderate to severe intimal arteritis comprising >25% of the luminal area (v2).
GRADE III - Cases with “transmural” arteritis or fibrinoid change and necrosis of medial smooth muscle cells (v3).
Borderline category is used when no intimal arteritis is present, but there are foci of mild tubulitis (1 to 4 mononuclear cells/tubular cross section)."|At Month 12|Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication. For this analysis, only patients with available data were included. The analysis included biopsies of Month 12 visit that were done beyond month 12 cut-off date.||Participants|||Number
728089|NCT00371826|Secondary|Number of Participants With Histological Evidence Chronic Allograft Nephropathy (CAN) (36 Months Analysis)|"Chronic rejection is characterized by a slow progressive decline in renal function and is typically preceded by the histological picture of chronic allograft nephropathy. The presence of biopsy confirmed Grade I, II or III chronic allograft nephropathy by Banff 97 criteria was assessed on all optional biopsies obtained for clinical suspicion of chronic rejection.
Data summarized by 3 categories. Yes - Patients with histological evidence of CAN ; No - Patients with histological evidence of CAN and Not Done - Central protocol defined kidney allograft biopsies were not done."|At Month 36|Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period. Patients with data available at month 36 were included in this analysis.||Participants|||Number
728090|NCT00371826|Secondary|Number of Participants With Histological Evidence Chronic Allograft Nephropathy (CAN) (12 Months Analysis)|"A per-protocol biopsy was performed at Baseline and Month 12 and read by an independent blinded pathologist in order to assess chronic allograft nephropathy. Chronic rejection is characterized by a slow progressive decline in renal function and is typically preceded by the histological picture of chronic allograft nephropathy. The presence of biopsy confirmed Grade I, II or III chronic allograft nephropathy by Banff 97 criteria was assessed on all optional biopsies obtained for clinical suspicion of chronic rejection.
Data summarized by 3 categories. Yes - Patients with histological evidence of CAN ; No - Patients with histological evidence of CAN and Not Done - Central protocol defined kidney allograft biopsies were not done."|At Month 12|Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication. For this analysis, only patients with available data were included. The analysis included biopsies of Month 12 visit that were done beyond month 12 cut-off date.||Participants|||Number
728091|NCT00371826|Secondary|Number of Participants With Composite Endpoint of Treatment Failure (36 Months Analysis)|"Composite endpoint of treatment failure includes biopsy-proven acute rejection (BPAR), graft loss, death and loss-to-follow-up. A BPAR is defined as a biopsy graded IA, IB, IIA, IIB, or III as per Banff 97 classification.
The allograft was presumed to be lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis. If the patient underwent a graft nephrectomy, then the day of nephrectomy was the day of graft loss."|At Month 12, 24 and 36|Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period. This population includes also all patients who were randomized but were not treated with study medication.||Participants|||Number
728092|NCT00371826|Secondary|Number of Participants With Composite Endpoint of Treatment Failure (12 Months Analysis)|"Composite endpoint of treatment failure includes biopsy-proven acute rejection (BPAR), graft loss, death and loss-to-follow-up. A BPAR is defined as a biopsy graded IA, IB, IIA, IIB, or III as per Banff 97 classification.
The allograft was presumed to be lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis. If the patient underwent a graft nephrectomy, then the day of nephrectomy was the day of graft loss."|Month 12|Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication.||Participants|||Number
728093|NCT00371826|Secondary|Number of Participants With Biopsy Proven Acute Rejection (BPAR) Per Treatment Group (36 Months Analysis)|A biopsy-proven acute rejection is defined as a biopsy graded IA, IB, IIA, IIB, or III as per Banff 97 classification.|At Month 12, 24 and 36|Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period. This population includes also all patients who were randomized but were not treated with study medication.||Participants|||Number
728094|NCT00371826|Secondary|Number of Participants With Biopsy Proven Acute Rejection (BPAR) Per Treatment Group (12 Months Analysis)|A biopsy-proven acute rejection is defined as a biopsy graded IA, IB, IIA, IIB, or III as per Banff 97 classification.|At Month 12|Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication.||Participants|||Number
728095|NCT00371826|Secondary|Calculated Glomerular Filtration Rate (cGFR) After Kidney Transplant to Evaluate Kidney Function (36 Months Analysis)|The glomerular filtration rate (GFR) was calculated by the Nankivell formula: GFR = 6.7 / Scr + BW / 4 - Surea / 2-100 / (height)^ 2 + C where Scr is the serum creatinine concentration expressed in mmol/L, BW the body weight in kg, Surea the serum urea in mmol/L, height in m, and the constant C is 35 for male and 25 for female patients.|At Month 24 and 36|Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period. Missing values were imputed by last observation carried forward (LOCF) using values beyond Month 6||mL/min per 1.73 m^2||Standard Error|Mean
728096|NCT00371826|Primary|Calculated Glomerular Filtration Rate (cGFR) After Kidney Transplant to Evaluate Kidney Function (12 Months Analysis)|The glomerular filtration rate (GFR) was calculated by the Nankivell formula: GFR = 6.7 / Scr + BW / 4 - Surea / 2-100 / (height)^ 2 + C where Scr is the serum creatinine concentration expressed in mmol/L, BW the body weight in kg, Surea the serum urea in mmol/L, height in m, and the constant C is 35 for male and 25 for female patients.|At Month 12|Modified intent-to-treat (mITT)-Add population: All ITT patients who had a calculated GFR value recorded at Month 12 post-randomization including those collected after discontinuation of study medication and retrospectively collected creatinine and urea data||mL/min per 1.73 m^2||Standard Deviation|Mean
728097|NCT00377637|Secondary|Maintenance Phase: Participants With Major Extra-renal Flare|A major extra-renal flare is defined as a British Isles Lupus Assessment Group (BILAG) Score category A in one extrarenal organ or three organs with concurrent category B scores. BILAG indices provide a scoring system for the assessment of lupus disease activity in terms of the need for steroid treatment in 8 organs/systems. Eighty-six items were scored resulting in a classification of A (severe activity), B (moderate activity), C (mild activity), D (no current activity) and E (no activity ever observed) for each organ system.|From the start of the Maintenance Phase to Month 36|Maintenance Phase intent to treat population.||participants|||Number
728098|NCT00377637|Secondary|Maintenance Phase: Events Contributing to the Primary Endpoint: Kaplan-Meier Estimates of Percentage of Participants Not Receiving Rescue Therapy|The primary efficacy parameter was the time to treatment failure, adjudicated by the Clinical Endpoints Committee (CEC), defined as any of the following: death, end stage renal disease, sustained doubling of serum creatinine, renal flare, or requirement for rescue therapy to treat deterioration or exacerbation of Lupus nephritis. Kaplan-Meier survival curves were estimated from the observed time to rescue treatment for each patient. The data presented are the percentage of participants who were rescue treatment free at each time interval as estimated by Kaplan-Meier.|From the start of the Maintenance Phase to Month 36|Maintenance Phase intent to treat population. The analysis includes all event data, regardless of whether or not the event was the earliest Clinical Endpoints Committee-adjudicated reason for treatment failure.||Percentage of participants|||Number
728099|NCT00377637|Secondary|Maintenance Phase: Events Contributing to the Primary Endpoint: Kaplan-Meier Estimates of Percentage of Participants Renal Flare Free, by Time Interval|A proteinuric flare is defined as a doubling of the urine protein:creatinine ratio, and proteinuria ≥1 g/24 h in patients with urine protein ≤0.5 g/24 h at the end of the induction phase, or proteinuria ≥2 g/24 h if urine protein was >0.5 g/24 h at the end of the induction phase. A nephritic flare is defined as a 25% increase in serum creatinine accompanied by 1 or more of the following: (a) simultaneous doubling of the proteinuria reaching a minimum of 2 g/24 h (b) new/increased hematuria or (c) the appearance of cellular casts. All flares were adjudicated by a clinical endpoints committee.|From the start of the Maintenance Phase to Month 36|Maintenance Phase intent to treat population. The analysis includes all event data, regardless of whether or not the event was the earliest Clinical Endpoints Committee-adjudicated reason for treatment failure.||Percentage of participants|||Number
728100|NCT00377637|Secondary|Maintenance Phase: Events Contributing to the Primary Endpoint: Number of Participants With Sustained Doubling of Serum Creatinine|Sustained doubling of serum creatinine concentration is defined as the first serum creatinine value that is twice the mean of the lowest 2 values from screening to end of induction, as confirmed by a second serum creatinine value obtained at least 4 weeks after the initial doubling.|From the start of the Maintenance Phase to Month 36|Maintenance Phase intent to treat population. The analysis includes all event data, regardless of whether or not the event was the earliest Clinical Endpoints Committee-adjudicated reason for treatment failure.||participants|||Number
728101|NCT00377637|Secondary|Maintenance Phase: Events Contributing to the Primary Endpoint: Number of Participants With End-stage Renal Disease (ESRD)|Time to treatment failure, adjudicated by the Clinical Endpoints Committee (CEC), was defined as any 1 the following: death, ESRD, sustained doubling of serum creatinine, renal flare (proteinuric or nephritic), or requirement for rescue therapy to treat deterioration or exacerbation of Lupus nephritis. ESRD is defined as progression to chronic hemodialysis or renal transplant.|From the start of the Maintenance Phase to Month 36|Maintenance Phase intent to treat population. The analysis includes all event data, regardless of whether or not the event was the earliest Clinical Endpoints Committee-adjudicated reason for treatment failure.||participants|||Number
728102|NCT00377637|Secondary|Maintenance Phase: Events Contributing to the Primary Endpoint: Number of Deaths|Treatment Failure was adjudicated by a clinical endpoints committee (CEC) and was defined as the time to the earliest occurrence of any one of the following: death, end stage renal disease, sustained doubling of serum creatinine, renal flare, or a requirement for rescue therapy for exacerbation or deterioration of Lupus nephritis (LN).|From the start of the Maintenance Phase to Month 36|Maintenance Phase intent to treat population.||Deaths|||Number
728103|NCT00377637|Secondary|Induction Phase: Change From Baseline in Short-Form Health Survey (SF-36) Domain and Component Scores|The SF-36 is a 36 item quality of life questionnaire. The short-form version has eleven questions that permit the participant to rate how they feel that particular day. The SF-36 consists of eight scaled scores and two component scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 score with the higher scores indicating better quality of life.|Baseline and 24 weeks|"This analysis population is intention to treat. The analysis included only those patients for whom data was available at both time points, as indicated by n."||Scores on a scale||Standard Deviation|Mean
728262|NCT00379587|Secondary|Incidence of Grade 3 or Higher Infectious Complications||by 1 and 2 years after peripheral blood stem cell (PBSC) infusion|||percentage of participants|||Number
728104|NCT00377637|Secondary|Induction Phase: Change in Renal British Isles Lupus Assessment Group (BILAG) Score|"BILAG indices provide a scoring system for the assessment of lupus disease activity in terms of the need for steroid treatment in 8 organs/systems. Eighty-six items were scored resulting in a classification of A (severe activity), B (moderate activity), C (mild activity), D (no current activity) and E (no activity ever observed) for each organ system. The BILAG individual system summaries were calculated by a program supplied by ADS-Limathon (Sheffield, UK).
The score at baseline was compared to the score at the 24 week endpoint for each treatment group, reported here for the renal system."|Baseline, 24 weeks|Analysis population was intent to treat. The endpoint was defined using the last observation carried forward approach. If no post-Baseline value was available, endpoint was considered missing.||Percentage of participants|||Number
728105|NCT00377637|Secondary|Induction Phase: Change From Baseline to Week 24 in Serum Albumin||Baseline, Week 24|"Analysis population was intent to treat. The analysis included only those patients for whom data was available at both time points, as indicated by n."||g/L||Standard Deviation|Mean
728106|NCT00377637|Secondary|Induction Phase: Change From Baseline to Week 24 in 24-hour Urine Protein|24-hour urine protein was measured at Baseline and Week 24.|Baseline, Week 24|"Analysis population was intent to treat. The analysis included only those patients for whom data was available at both time points, as indicated by n."||mg/day||Standard Deviation|Mean
728107|NCT00377637|Secondary|Induction Phase: Change From Baseline to Week 24 in Serum Creatinine||Baseline, Week 24|"Analysis population was intent to treat. The analysis included only those patients for whom data was available at both time points, as indicated by n."||µmol/L||Standard Deviation|Mean
728108|NCT00377637|Secondary|Induction Phase: Number of Participants Achieving Complete Remission|Number of participants achieving complete remission as defined by return to normal serum creatinine, proteinuria ≤500 mg/24 hours and an inactive urinary sediment (absence of red blood cells, white blood cells or cellular or granular casts) after 24 weeks.|24 weeks|Analysis population was intent to treat.||participants|||Number
728109|NCT00377637|Primary|Maintenance Phase: Kaplan-Meier Estimates of Percentage of Participants Treatment Failure Free, by Time Interval|Treatment Failure was adjudicated by a clinical endpoints committee and was defined as the time to the earliest occurrence of any one of the following: death, end stage renal disease, sustained doubling of serum creatinine, renal flare, or a requirement for rescue therapy for exacerbation or deterioration of Lupus nephritis. Kaplan-Meier survival curves were estimated from the observed time to treatment failure for each patient. The data presented are the percentage of participants who were treatment-failure free at each time interval as estimated by Kaplan-Meier.|From the start of the Maintenance Phase to Month 36|Intent to treat analysis population which consisted of all subjects who were randomized to the maintenance phase of the study and had at least 1 maintenance efficacy assessment.||Percentage of participants|||Number
728110|NCT00377637|Primary|Induction Phase: Number of Patients Showing Treatment Response|Treatment response was adjudicated by a blinded clinical endpoints committee (CEC) and defined as: a) Decrease in proteinuria, defined as a decrease in the urine protein to creatinine ratio (UPCr) to <3 in subjects with baseline proteinuria ≥3 UPCr or a decrease in the UPCr by ≥50% in subjects with proteinuria <3 UPCr at Baseline, and b) Stabilization of serum creatinine or improvement. UPCr were derived from the 24 hour urine collection. Patients who did not show a treatment response at Week 24 or who withdrew earlier than Week 24 were considered non-responders.|24 weeks|Analysis population was intent to treat which comprised all subjects who were randomized into the study and had at least one post-baseline efficacy assessment.||participants|||Number
728111|NCT00377676|Secondary|Change in HbA1c From Baseline to Week 24 for Subjects With a Baseline HbA1c of ≥ 7.5% Who Were Taking at Least One Oral Hypoglycemia Agent (OHA) at Baseline.|The difference between Cycloset and placebo in the change in HbA1c from baseline to Week 24 was analyzed for subjects with a baseline HbA1c of ≥ 7.5% who were taking at least one oral hypoglycemia agent (OHA) at baseline. The primary analysis was based on subjects from the evaluable per protocol efficacy (EPPE) analysis set with a secondary analysis using subjects from the intent to treat efficacy (ITTE) analysis set for subjects completing 24 weeks of treatment. Change is reported as the absolute difference in % HbA1c.|Baseline to week 24|randomized subjects with a baseline HbA1c of >= 7.5 taking one or two oral diabetes agents (not insulin)||percent||Standard Deviation|Least Squares Mean
728112|NCT00377676|Secondary|Change in HbA1c From Baseline to Week 24 in Subjects Failing Treatment With Metformin Plus a Sulfonylurea|"Change in HbA1c from baseline to week 24 in subjects failing treatment with metformin plus a sulfonylurea with failure defined as having a baseline HbA1c value of ≥ 7.5%. Change was measured at week 24 after randomization in subjects having no major protocol violations.
Change is reported as the absolute difference in % HbA1c."|Baseline to week 24|subjects with baseline HbA1c of >= 7.5 and taking both metformin/sulfonylurea but not insulin. Analysis was conducted for those completing 24 weeks of treatment and on the ITT using the LOCF for those not completing 24 weeks of treatment.||percent||Standard Deviation|Least Squares Mean
728113|NCT00377676|Secondary|Number of Subjects Experiencing Serious Cardiovascular Adverse Events|The secondary safety endpoint is number subjects with occurrences of first cardiovascular SAE (myocardial infarction, stroke, in-patient hospitalization for heart failure, angina or revascularization surgery).|Baseline to week 52.|intent to treat||Subjects|||Number
728114|NCT00377676|Primary|Subjects Experiencing Serious Adverse Events|Number of subjects reporting all-cause Serious Adverse Events (SAEs) for usual drug therapy plus Cycloset vs. that for usual drug therapy (UDT) plus placebo from baseline to week 52.|From baseline to week 52.|||participants|||Number
728115|NCT00377741|Secondary|Plasma Half-Life (T1/2) of Ganciclovir|Plasma half-life is the time measured for the plasma concentration to decrease by one half. The pharmacokinetic parameters of Valganciclovir were measured in plasma of all participants following a single tablet dose Valganciclovir at 900 mg at start of treatment on Day 1. T1/2 was not reported for those participants for whom R-squared (adjusted) was lower than 0.70.|Pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12 and 24 hours post-dose|The Pharmacokinetic (PK) analysis population included all participants who received study medication and had at least one PK sample.||h||Standard Deviation|Mean
728263|NCT00379587|Primary|Incidence of Clinician-diagnosed Chronic GVHD at One and Two Years||by 1 and 2 years after peripheral blood stem cell (PBSC) infusion|||percentage of participants|||Number
729758|NCT00383110|Secondary|LDL-cholesterol||12-months after enrollment|Discrepancies in number of participants analyzed is due to some participants having no data in their medical record for this measure.||mg/dL||Standard Deviation|Mean
728116|NCT00377741|Secondary|Apparent Elimination Rate (Kelim) of Ganciclovir|The apparent elimination rate is equal to the magnitude of the slope from the log-linear regression of plasma concentration versus time over the interval t to 24, where t is the first time-point used for this regression. Kelim was not reported for those participants for whom R-squared (adjusted) was lower than 0.70.|Pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12 and 24 hours post–dose|The Pharmacokinetic (PK) analysis population included all participants who received study medication and had at least one PK sample.||1/h||Standard Deviation|Mean
728117|NCT00377741|Secondary|Time to Maximum Observed Plasma Concentration (Tmax) of Ganciclovir|The Tmax is defined as time to reach maximum observed Ganciclovir concentration. The pharmacokinetic parameters of Valganciclovir were measured in plasma of all participants following a single tablet dose Valganciclovir at 900 mg at start of treatment on Day 1.|Pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12 and 24 hours post–dose|The Pharmacokinetic (PK) analysis population included all participants who received study medication and had at least one PK sample.||h||Full Range|Median
728118|NCT00377741|Primary|Maximum Observed Plasma Concentration (Cmax) of Ganciclovir|The Cmax is defined as maximum observed Ganciclovir concentration. Cmax of valganciclovir were measured in plasma of all participants following a single tablet dose Valganciclovir at 900 mg at start of treatment on Day 1.|Pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12 and 24 hours post-dose|The Pharmacokinetic (PK) analysis population included all participants who received study medication and had at least one PK sample.||μg/mL||Standard Deviation|Mean
728119|NCT00377741|Primary|Area Under The Observed Plasma Concentration-Time Curve Between Dosing Intervals AUC(0-tau)|The area under the plasma concentration-time curve from time zero to end of dosing interval (AUC [0-tau]) is a measure of the plasma ganciclovir concentration from time zero to end of dosing interval. It was computed using the linear trapezoidal rule. The pharmacokinetic parameters of valganciclovir were measured in plasma of all participants following a single oral dose valganciclovir at 900 mg on Day 1.|Pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12 and 24 hours post–dose|The Pharmacokinetic (PK) analysis population included all participants who received study medication and had at least one PK sample.||h*mcg/mL||Standard Deviation|Mean
728120|NCT00377819|Secondary|Percent Change From Baseline in Serum C-Telopeptide-I (CTX-I)|Percent Change From Baseline to Month 3 in Serum CTX-I. Percent change calculated using [(3 month value - baseline value) / baseline value]*100.|Baseline, 3 months|Participants with non-missing baseline evaluation and non-missing post-baseline evaluation at month 3.||Percent Change||Inter-Quartile Range|Median
728121|NCT00377819|Secondary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change calculated using [(12 month value - baseline value) / baseline value]*100.|Baseline, 12 months|Participants with non-missing baseline evaluation and at least 1 non-missing post-baseline evaluation.||Percent Change||95% Confidence Interval|Least Squares Mean
728122|NCT00377819|Primary|Percent Change From Baseline in Total Hip Bone Mineral Density|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change calculated using [(12 month value - baseline value) / baseline value]*100.|Baseline, 12 months|Participants with non-missing baseline evaluation and at least 1 non-missing post-baseline evaluation.||Percent Change||95% Confidence Interval|Least Squares Mean
728123|NCT00377832|Secondary|Rate of Neonatal Sepsis|the number of participants who developed neonatal sepsis|7 days|||participants|||Number
728124|NCT00377832|Secondary|Rate of Diagnosis of Clinical Chorioamnionitis|Rate of diagnosis of clinical chorioamnionitis, i.e., the number of participants who developed chorioamnionitis.|Labor--up to 24 hours|||participants|||Number
728125|NCT00377832|Secondary|Rate of Subsequent Development of Maternal Fever|Rate of subsequent development of maternal fever, i.e., the number of participants who developed fever.|Labor--up to 24 hours|||participants|||Number
728126|NCT00377832|Secondary|Rate of Determination of Non-reassuring Fetal Status|Non-reassuring fetal status is when cesarean delivery or operative vaginal delivery (forceps or vacuum) are performed for fetal heart rate abnormalities.|Labor--up to 24 hours|||participants|||Number
728127|NCT00377832|Secondary|Rate of Cesarean Delivery|Rate of cesarean delivery|Labor--up to 24 hours|||participants|||Number
728128|NCT00377832|Secondary|Temperature Difference Before and After Treatment|Maternal temperature difference before randomization and 90 minutes after randomization in degrees Centigrade|90 minutes|||degrees Centigrade||Inter-Quartile Range|Median
728129|NCT00377832|Primary|Baseline Fetal Heart Rate (FHR) After Treatment||90 minutes|||beats per minute||Standard Deviation|Mean
728130|NCT00377832|Primary|Maternal Body Temperature 90 Minutes After Randomization|Fever in labor is identified,consenting and randomization occurs, either acetaminophen is given or no medication is given, then 90 minutes later maternal temperature is recorded.|90 minutes|||degrees centigrade||Inter-Quartile Range|Median
728131|NCT00377858|Secondary|Change From Baseline in Absolute Body Weight at 36 Week Endpoint|Change in body weight was calculated as weight at endpoint (last observation carried forward) minus weight at baseline.|Baseline, 36 Weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.||kilograms||Standard Error|Least Squares Mean
728132|NCT00377858|Secondary|Number of Insulin Injections Per Day||Weeks 12, 24, 30, 36|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. If the patient completed the trial, the endpoint was 36 weeks (Week 36), but if the patient dropped out of the study early, the last observation carried forward (LOCF) was considered as the endpoint (Endpoint).||insulin injections||Standard Error|Least Squares Mean
728133|NCT00377858|Secondary|Endpoint Insulin Dose; Total, Basal, and Prandial|Total daily insulin dose (Units of insulin per day [U/day]) was assessed. Basal insulin is the amount of insulin required to manage normal daily blood glucose fluctuations. Prandial insulin is taken at meal time. Insulin glargine is a basal insulin and insulin lispro is a prandial insulin. Insulin lispro mid-mix is a 50/50 mixture of a basal insulin and insulin lispro. Endpoint: last visit interval based on LOCF.|36 Weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.||U/day||Standard Error|Least Squares Mean
728400|NCT00380068|Secondary|Failure-free Treatment Status|Defined by occurrence of death, lung transplantation, or study withdrawal due to the addition of other clinically approved PAH therapeutic agents|Baseline to Week 24|Full Analysis Set. Participants who were lost to follow-up were censored at the date of last contact.||Percentage of participants|||Number
728134|NCT00377858|Secondary|Endpoint Insulin Dose Per Body Weight; Total, Basal, and Prandial|Total daily insulin dose adjusted for body weight (Units of insulin per kilogram per day [U/kg/day]) was assessed. Basal insulin is the amount of insulin required to manage normal daily blood glucose fluctuations. Prandial insulin is taken at meal time. Insulin glargine is a basal insulin and insulin lispro is a prandial insulin. Insulin lispro mid-mix is a 50/50 mixture of a basal insulin and insulin lispro. Endpoint: last visit interval based on LOCF.|36 Weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.||U/kg/day||Standard Error|Least Squares Mean
728135|NCT00377858|Secondary|Number of Patients With at Least One Severe Hypoglycemia Episode|Severe hypoglycemia was defined as hypoglycemic event that meets at least one of the following criteria: not capable of treating self and blood glucose <2.8 millimoles per liter (mmol/L); not capable of treating self, blood glucose is missing and prompt recovery after oral carbohydrate or glucagon or intravenous glucose; hypoglycemic event outcome was coma, hopitalization, emergency room visit, or automobile accident. The overall category is a severe hypoglycemic event that occurred at any time during the post-randomization visits. Endpoint: last visit interval based on LOCF.|Baseline to 36 Weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.||participants|||Number
728136|NCT00377858|Secondary|30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal and Non-Nocturnal)|Hypoglycemic episode defined: any time patient felt that he/she was experiencing a sign or symptom associated with hypoglycemia, or had old Roche blood glucose level <70 mg/dL even if not associated with signs, symptoms, or treatment consistent with current guidelines. Nocturnal hypoglycemia defined: any hypoglycemic event that occurred between bedtime and waking. Non-nocturnal hypoglycemia defined: any hypoglycemic event that occurred between waking and bedtime. Overall episodes: those that occurred at any time during the post-randomization visits. Endpoint: last visit interval based on LOCF.|Baseline to 36 Weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. The last visit of trial interval was used to calculate hypoglycemic episodes at Endpoint if patient completes trial and last observation carried forward was used if the patient dropped out of the study early.||hypoglycemic event per 30 days||Standard Deviation|Mean
728137|NCT00377858|Secondary|Number of Patients With at Least One Self-reported Hypoglycemic Episode, Including Nocturnal (and Non-nocturnal) Hypoglycemia|Hypoglycemic episode defined: any time patient felt that he/she was experiencing a sign or symptom associated with hypoglycemia, or had old Roche blood glucose level <70 mg/dL even if not associated with signs, symptoms, or treatment consistent with current guidelines. Nocturnal hypoglycemia defined: any hypoglycemic event that occurred between bedtime and waking. Non-nocturnal hypoglycemia defined: any hypoglycemic event that occurred between waking and bedtime. Overall episodes: those that occurred at any time during the post-randomization visits. Endpoint: last visit interval based on LOCF.|Baseline to 36 Weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. The last visit of trial interval was used to calculate hypoglycemic episodes at Endpoint if patient completes trial and last observation carried forward was used if the patient dropped out of the study early.||participants|||Number
728138|NCT00377858|Secondary|Glycemic Variability|Glycemic variability was measured by mean blood glucose value (M-value), which was the mean of the intra-days self-monitoring blood glucose values, and by the mean of daily difference (MODD), which was the mean of the between-days self-monitored blood glucose values.|Baseline, 12-24-36 weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. If the patient completed the trial, the endpoint was 36 weeks (Week 36), but if the patient dropped out of the study early, the last observation carried forward (LOCF) was considered as the endpoint (Endpoint).||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
728139|NCT00377858|Secondary|7-point Self-monitored Blood Glucose Profiles|Actual daily mean blood glucose levels at specified time points.|Baseline, 12-24-36 weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. If the patient completed the trial, the endpoint was 36 weeks (Week 36), but if the patient dropped out of the study early, the last observation carried forward (LOCF) was considered as the endpoint (Endpoint).||millimoles per Liter (mmol/L)||Standard Error|Least Squares Mean
728140|NCT00377858|Secondary|Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint||12-24-36 weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. If the patient completed the trial, the endpoint was 36 weeks (Week 36), but if the patient dropped out of the study early, the last observation carried forward (LOCF) was considered as the endpoint (Endpoint).||percentage of participants|||Number
728141|NCT00377858|Secondary|Hemoglobin A1c (HbA1c) at Interval Visits|Levels of HbA1c at 12 weeks and 24 weeks and 36 weeks.|12, 24, and 36 weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population.||percent HbA1c||Standard Error|Least Squares Mean
728142|NCT00377858|Primary|Hemoglobin A1c (HbA1c) at 36 Week Endpoint|Level of hemoglobin A1c at endpoint.|36 weeks|Number of participants in the per-protocol population. Last observation carried forward.||percent HbA1c||Standard Error|Least Squares Mean
728143|NCT00378014|Secondary|Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Death|Patients with all (serious and non-serious) adverse events, serious adverse events and death were reported.|Month 12 to Month 59 post-baseline|Safety population: This set included all randomized patients with at least one post-baseline measurement of GFR.||Number of participants|||Number
728144|NCT00378014|Secondary|Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Death|Patients with all (serious and non-serious) adverse events, serious adverse events and death were reported.|From randomization to Month 11|Safety population: This set included all randomized patients with at least one post-baseline measurement of GFR.||Number of participants|||Number
728145|NCT00378014|Secondary|Hepatitis C Virus (HCV) Replication in HCV-positive Patients|HCV ribonucleic acid (RNA) was measured by real time reverse transcriptase polymerase chain reaction (PCR; copies per mL).|Baseline, Month 5|ITT||Percentage of participants|||Number
728433|NCT00380250|Secondary|Month 1 Abdominal Bloating Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|Change from baseline for month 1|ITT with LOCF||Scale score||Standard Deviation|Mean
728146|NCT00378014|Secondary|Patient and Graft Survival|Patient survival was defined as the time from date of randomization to date of death from any cause. If a patient was not known to have died, patient survival was censored as the date of last contact. Graft survival was defined as the time from the date of randomization to the date of graft loss. If a patient was not known to suffer from a graft loss or died without graft loss, time to graft loss was censored with date of last contact or date of death, respectively. Patient and graft survival were analyzed using the Kaplan Meier method.|Month 11|ITT||Percentage of Participants|||Number
728147|NCT00378014|Secondary|Incidence of Treated BPAR|The incidence of treated BPAR was estimated using crude rate estimation (relative frequency).|Month 11|ITT||Percentage of Participants|||Number
728148|NCT00378014|Secondary|Renal Function (cGFR)|This outcome measure evaluated renal function by assessing the calculated GFR based on the Cockcroft-Gault formula.|Month 5|ITT||mL/min||Standard Deviation|Mean
728149|NCT00378014|Secondary|Incidence of Renal Deterioration|Renal deterioration was defined as a decrease by ≥25% in the cGFR compared to baseline and confirmed by one consecutive measurement. The analysis of this outcome measure was omitted because of missing relevance.|Baseline, Month 11||||||
728150|NCT00378014|Secondary|Incidence of the Need for a Change in the Immunosuppressive Regimen|The incidence of any changes in the immunosuppressive regimen other than allowed in the study protocol (for example, introduction of Mycophenolic acid (MPA) or sirolimus) was estimated using crude rate estimation (relative frequency).|Month 11|ITT||Percentage of participants|||Number
728151|NCT00378014|Secondary|Incidence of Efficacy Failure|Efficacy failure was defined as the composite endpoint of biopsy-proven acute rejection (BPAR), graft loss, death, lost to follow-up (from any reason), whichever occurred first. Incidence of efficacy failure was estimated using crude rate estimation (relative frequency).|Month 11|ITT||Percentage of participants|||Number
728152|NCT00378014|Primary|Calculated Glomerular Filtration Rate (cGFR)|This outcome measure evaluated renal function by assessing the calculated GFR based on the Cockcroft-Gault formula.|Month 11|ITT||mL/min||Standard Deviation|Mean
728153|NCT00378079|Secondary|Employment|number of days employed, past 30 days-self report, assessed one year post-prison release|one year|||number of days employed, past 30||Standard Deviation|Mean
728154|NCT00378079|Primary|Criminal Activity|self reported days of criminal activity|one year post prison release|||number of days||Standard Deviation|Mean
728155|NCT00378079|Primary|HIV-risk Behaviors||one year||||||
728156|NCT00378079|Primary|Cocaine Use|cocaine urine test results-percent of participants testing positive for cocaine|one year post prison release|Includes participants who provided urine samples at the time their 1-year post-prison release assessment was due, excludes those assessed later or reincarcerated||percent cocaine positive participants|||Number
728157|NCT00378079|Primary|Heroin Use|opioid urine test results-percent of participants who were opioid-positive|results at one year post prison release|Includes participants who provided urine samples at the time their 1-year post-prison release assessment was due-excludes those assessed later or reincarcerated||% participants opioid positive|||Number
728158|NCT00378079|Primary|Treatment Retention in the Community|days in community treatment|one year post prison release|||Days in community treatment||Standard Deviation|Mean
728159|NCT00378105|Secondary|Estimated 18-month Overall Survival Rate|Overall survival was measured from treatment initiation to death, censored at the date patients were last known to be alive for those who had not died.|Survival rate at 18 months|||Percentage of participants||95% Confidence Interval|Number
728160|NCT00378105|Secondary|Percentage of Patients Who Remained in Response for More Than 18 Months|Duration of response was measured from first response to progression or death, censored at the date patients were last known to be alive and disease free for patients who had not progressed or died.|Response rate at 18 months|||Percentage of participants||95% Confidence Interval|Number
728161|NCT00378105|Secondary|Estimated 18-month Progression Free Survival (PFS) Rate|"PD from European Bone Marrow Transplant (EBMT) Response Criteria Required one or more:
>25% increased in the level of serum monoclonal paraprotein, which must also be an absolute increase of at least 5 g/L and confirmed on a repeat investigation, or >25% increased in 24-hour urinary light chain excretion (must also be an absolute increase of at least 200 mg/24 h and confirmed on a repeat investigation), or >25% increased in plasma cells in a bone marrow aspirate or biopsy (must also be an absolute increase of at least 10%) Definite increase in the size of existing lytic bone lesions or soft tissue plasmacytomas.
Development of new bone lesions or soft tissue plasmacytomas (not including compression fracture).
Development of hypercalcemia (corrected serum calcium >11.5 mg/dL or 2.8 mmol/L not attributable to any other cause).
PFS was measured from treatment initiation to progression or death, censored at the date patients were last known to be alive and disease free"|PFS rate at 18 months|This numbers excluded 2 patients who went off study prior to start of therapy.||Percentage of participants||95% Confidence Interval|Number
728162|NCT00378105|Primary|Objective Response Rate of the Drug Combination in This Patient Populations.|Overall Response (OR) was defined as partial response (PR) or better. Response was assessed according to European Group for Blood and Marrow Transplant criteria, modified to include nCR and VGPR, from the International Uniform Response Criteria.|Full response assessment was conducted at the end of cycle 8 (average of168 days) and after cycle 4 (84 days) for patients proceeding to transplant.|The numbers excluded 2 patients who went off study prior to start of therapy||percentage of participants||90% Confidence Interval|Number
728163|NCT00378209|Secondary|Overall Survival|defined as time from treatment initiation to death, or last known to be alive for those who had not died|assesed at a median follow-up of 44 months|||month||95% Confidence Interval|Median
728164|NCT00378209|Secondary|Progression Free Survival|Progression-free survival is defined as the time from registration to the disease progression or death from any cause, censored at date last known progression-free for those who have not progressed or died.|aassesed at a median follow-up of 44 months|||months||95% Confidence Interval|Median
728165|NCT00378209|Secondary|Duration of Response|Duration of response will be measured as the time from initiation of a response to first documentation of disease progression or death, or date last known progression-free and alive for those who have not progressed or died.|Assessed at a median follow-up of 44 months|||months||95% Confidence Interval|Median
728434|NCT00380250|Secondary|Month 3 Symptom Relief|Significantly worse = -3; Moderately worse = -2; A little bit worse = -1; Unchanged = 0; A little bit relieved=1; Moderately relieved=2; Significantly relieved = 3|Change from baseline for month 3|ITT with LOCF||Scale score||Standard Deviation|Mean
728167|NCT00378209|Primary|The Proportion of Patients Alive and Without Progressive Disease (PD) for ≥6 Months|"Response assessed by the European Group for Blood and Marrow Transplant (EBMT) criteria, modified to include nCR and VGPR from the international uniform response criteria (IMWG).
Progressive disease (PD) required one or more of the following:
>25% increased in serum monoclonal paraprotein (must also be an absolute increase of at least 5 g/L and confirmed on a repeat investigation) >25% increased in 24-hour urinary light chain excretion (must also be an absolute increase of at least 200 mg/24 h and confirmed on a repeat investigation) >25% increased in plasma cells in a bone marrow aspirate or on trephine biopsy (must also be an absolute increase of at least 10%) Definite increase in the size of existing lytic bone lesions or soft tissue plasmacytomas.
Development of new bone lesions or soft tissue plasmacytomas (not including compression fracture).
Development of hypercalcemia (corrected serum calcium >11.5 mg/dL or 2.8 mmol/L not attributable to any other cause)."|6 months after therapy|||percentage of treated patients||90% Confidence Interval|Number
728168|NCT00378326|Primary|Survival of Patients With Paraneoplastic Disease Who Are Treated With Tacrolimus|Survival in patients with paraneoplastic disease who are treated with Tacrolimus, from time of tacrolimus treatment|through study completion, median 3 years of follow up|||months||95% Confidence Interval|Median
728169|NCT00378326|Secondary|Cerebrospinal Fluid (CSF) Pleocytosis||White blood cell count in CSF was measured at two time points, pre- and post-treatment|"19 treatment events in 16 patients at which both pre- and post-treatment CSF samples available.
The data are reported below, separately for pre-treatment samples and post-treatment samples."||cells/mm^3|Participants|Full Range|Median
728170|NCT00378352|Secondary|Number of Participants With Clinical Events||from randomization to second CMR|||Participants|||Count of Participants
728171|NCT00378352|Secondary|Reticulocyte Counts||baseline, 24 hours, 48 hours, 14 (+/- 5) days, and 30 (+/- 5) days|||percentage of red blood cells||Standard Deviation|Mean
728172|NCT00378352|Secondary|Hemoglobin Levels||baseline, 24 hours, 48 hours, 14 (+/- 5) days, and 30 (+/- 5) days|||g/dL||Standard Deviation|Mean
728173|NCT00378352|Secondary|Vital Signs||baseline, 24 hours, 48 hours, 14 (+/- 5) days, and 30 (+/- 5) days|||mmHg||Standard Deviation|Mean
728174|NCT00378352|Secondary|LV Mass Indexed to BSA||2 to 6 days after study medication administration (first CMR) and 12 ± 2 weeks later (second CMR)|Analysis only performed on subjects who completed this component of the CMR examination||g/m^2||Standard Deviation|Mean
728175|NCT00378352|Secondary|LV Volume Indexed to BSA||2 to 6 days after study medication administration (first CMR) and 12 ± 2 weeks later (second CMR)|Analysis only performed on subjects who completed this component of the CMR examination||ml/m^2||Standard Deviation|Mean
728176|NCT00378352|Secondary|LV Ejection Fraction||2 to 6 days after study medication administration (first CMR) and 12 ± 2 weeks later (second CMR)|Analysis only performed on subjects who completed this component of the CMR examination||percent||Standard Deviation|Mean
728177|NCT00378352|Secondary|Infarct Size in the Territory of the Infarct Related Artery|Infarct size, expressed as percentage of LV mass, assessed by cardiac magnetic resonance (CMR) imaging.|12 ± 2 weeks after study medication|Analysis only performed on subjects who completed the CMR examination||percentage of LV mass||Standard Deviation|Mean
728178|NCT00378352|Primary|Infarct Size in the Territory of the Infarct Related Artery|Infarct size, expressed as percentage of LV mass, assessed by cardiac magnetic resonance (CMR) imaging.|performed 2 to 6 days after study medication administration (first CMR)|Analysis only performed on subjects who completed the CMR examination||percentage of LV mass||Standard Deviation|Mean
728179|NCT00378378|Secondary|Change From Baseline 24-hour Urinary Free Cortisol Level Corrected for Creatinine|The key secondary objective of this study was the assessment of the 24-hour urinary free cortisol level (corrected for creatinine).|Baseline to Endpoint|||mcg/hour||Standard Deviation|Least Squares Mean
728180|NCT00378378|Primary|Change From Baseline 24-hour Urinary Free Cortisol Level|The primary objective of this study was to evaluate the safety of Mometasone Furoate Nasal Spray (MFNS) in the treatment of pediatric subjects 6 to <18 years of age. Primary safety was to be assessed by determining the subject’s 24-hour urinary free cortisol level.|Baseline to Endpoint|Not all participants that were randomized had both a baseline and an endpoint urine sample. Only participants with both were included in the participants analyzed.||mcg/hour||Standard Deviation|Least Squares Mean
728181|NCT00378508|Secondary|Baseline Hemoglobin A1c||At baseline (before treatment)|||percentage of hemoglobin A1c||95% Confidence Interval|Least Squares Mean
728182|NCT00378508|Secondary|Baseline Insulin Use||At baseline (before treatment)|This endpoint was compared in the modified intent to treat population which included all subjects with at least one post-randomization mixed meal tolerance test (MMTT)||U/kg/d||95% Confidence Interval|Least Squares Mean
728183|NCT00378508|Primary|C-peptide Area Under the Curve (AUC) Response to a Mixed Meal Tolerance Test (MMTT) at Baseline|"C-peptide secretory response was calculated as ln[(Area Under the Curve of the C-peptide from the 240 minute MMTT/240 +1]
For presentation, the C-peptide data were converted to the AUC as pmol/ml. This baseline data was used to adjust for the C-peptide AUC primary endpoint measure at 12 months."|At Baseline (before treatment)|This endpoint was compared in the modified intent to treat population which included all subjects with at least one post-randomization mixed meal tolerance test (MMTT)||pmol/ml||95% Confidence Interval|Least Squares Mean
728184|NCT00378508|Secondary|Average Insulin Use Over 12 Months||After 12 months post-treatment|This endpoint was compared in the modified intent to treat population which included all subjects with at least one post-randomization mixed meal tolerance test (MMTT)||U/kg/d||95% Confidence Interval|Least Squares Mean
728185|NCT00378508|Secondary|Hemoglobin A1c||At 12 months post-treatment|||percentage of hemogloblin A1c||95% Confidence Interval|Least Squares Mean
728186|NCT00378508|Primary|C-peptide Area Under the Curve (AUC) Response to a Mixed Meal Tolerance Test (MMTT) at 12 Months|"C-peptide secretory response was calculated as ln[(Area Under the Curve of the C-peptide from the 240 minute MMTT/240 +1]
For presentation, the C-peptide data were converted to the AUC as pmol/ml. This is adjusted for baseline."|At month 12 post-treatment|This endpoint was compared in the modified intent to treat population which included all subjects with at least one post-randomization mixed meal tolerance test (MMTT)||pmol/ml||95% Confidence Interval|Least Squares Mean
728187|NCT00378534|Secondary|Standard Transplant Outcome Variables Such as Non-hematologic Toxicity, Incidence and Severity of Acute and Chronic GVHD and Relapse of Disease.||3 years maximum||||||
728188|NCT00378534|Primary|Survival and Non-relapse Mortality at Day +200 Using the Miltenyi Reagent System|Subjects with hematological malignancies receiving a myeloablative conditioning regimen of cyclophosphamide, fludarabine and total body irradiation followed by an infusion of stem cell product prepared using the Miltenyi CliniMacs system for CD34 selection and a delayed T cell depletion add back as donor lymphocyte infucion at day 90. The subjects receiveing allogeneic stem cell transplantation will have stem cell product prepared using Miltenyi CliniMacs system to determine the overall survival and non-relapse mortality at day +200.|Day 200|||participants|||Number
728189|NCT00378560|Secondary|Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 18)|"Month 7 HPV cLIA Geometric Mean Titers by vaccine group.
The limit of detection of the assay was 10 mMU/ml. GMTs and confidence limits below the limit of detection are shown as 10.0."|At one month after completed vaccination series (Month 7)|Includes participants who were not general protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 for the relevant HPV type, and had a Month 7 serum sample collected within an acceptable time range||Geometric Mean Titers||95% Confidence Interval|Geometric Mean
728190|NCT00378560|Secondary|Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 16)|"Month 7 HPV cLIA Geometric Mean Titers by vaccine group.
The limit of detection of the assay was 11 mMU/ml. GMTs and confidence limits below the limit of detection are shown as 11.0."|At one month after completed vaccination series (Month 7)|Includes participants who were not general protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 for the relevant HPV type, and had a Month 7 serum sample collected within an acceptable time range||Geometric Mean Titers||95% Confidence Interval|Geometric Mean
728191|NCT00378560|Secondary|Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 11)|"Month 7 HPV cLIA Geometric Mean Titers by vaccine group.
The limit of detection of the assay was 8 mMU/ml. GMTs and confidence limits below the limit of detection are shown as 8.0."|At one month after completed vaccination series (Month 7)|Includes participants who were not general protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 for the relevant HPV type, and had a Month 7 serum sample collected within an acceptable time range||Geometric Mean Titers||95% Confidence Interval|Geometric Mean
728192|NCT00378560|Secondary|Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 6)|"Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers (GMTs) by vaccine group.
The limit of detection of the assay was 7 mMU/ml. GMTs and confidence limits below the limit of detection are shown as 7.0."|At one month after completed vaccination series (Month 7)|Includes participants who were not general protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 for the relevant HPV type, and had a Month 7 serum sample collected within an acceptable time range||Geometric Mean Titers||95% Confidence Interval|Geometric Mean
728193|NCT00378560|Primary|Combined Incidence of Persistent Human Papillomavirus (HPV) 6, 11, 16 and 18 Infection or HPV 6, 11, 16 and 18 Related-Disease as Determined by Clinical/Pathologic Criteria and Positive Polymerase Chain Reaction (PCR) Assay for Virus Subtype|Participants with HPV 6, 11, 16 or 18 persistent infection, and genital disease (e.g., cervical, vaginal or vulval intraepithelial neoplasia, or cancer, adenocarcinoma in situ and genital warts) per 100 person-years of follow up.|Over 30 months|Includes participants who were not general protocol violators, received all 3 vaccinations, and were seronegative at Day 1 and PCR negative through Month 7 for the relevant HPV type||Incidence per 100 person-years|||Number
728194|NCT00378573|Secondary|Overall Survival|Survival is defined as the time from the date of registration to the study to the date of death.|2 years post-registration|Due to early termination of the study only 17/90 subjects enrolled. Efficacy analysis of Progression Free Survival and Overall Survival were not performed. Efficacy results limited to a descriptive summary of best overall response for each subject.||Month|||Number
728195|NCT00378573|Secondary|Objective Response Rate (Complete Response [CR] Plus Partial Response [PR]) Using Response Evaluation Criteria in Solid Tumors (RECIST)|"Complete response is defined as disappearance of all target and nontarget lesions identified and reported at baseline (at or within 4 weeks before the beginning of treatment) by image-based evaluations such as computerized tomography (CT) or magnetic resonance imaging (MRI).
Partial response is defined as persistence of one or more nontarget lesions and at least 30 percent decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters."|1 year from start of treatment|Due to early termination of the study only 17/90 subjects enrolled. Efficacy analysis of Progression Free Survival and Overall Survival were not performed. Efficacy results limited to a descriptive summary of best overall response for each subject.||Participants|||Number
728196|NCT00378573|Primary|Progression Free Survival for Subjects With Locally Advanced or Metastatic (Stage IIIB or Stage IV) Non-Small Cell Lung Cancer (NSCLC) After Systemic Treatment With Gemcitabine, Docetaxel, and Bevacizumab as First Line Therapy||1 year post-registration|Due to early termination of the study only 17/90 subjects enrolled. Efficacy analysis of Progression Free Survival and Overall Survival were not performed. Efficacy results limited to a descriptive summary of best overall response for each subject.||Days||95% Confidence Interval|Median
728197|NCT00378599|Primary|A Sustained Virologic Response (SVR), Defined as a Plasma HCV RNA Level Below the Lower Level of Quantitation (LLQ) at 24 Weeks Post-treatment|Number of participants with SVR at 24-week follow up after treatment with PEG-Intron and Ribavirin in post-orthotopic liver transplant recipients with recurrent HCV.|24 weeks after completion of up to 48 weeks of therapy|Intent to Treat (ITT) Data Set: All enrolled subjects who received at least one dose of any study medication (PEG-Intron or Rebetol (RBV)). Analysis of all primary and secondary efficacy endpoints and safety variables was based on the ITT population.||Participants|||Number
728198|NCT00378703|Secondary|Objective Response Rate|Response was assessed using Solid Tumor Response Criteria (RECIST). Patients with complete responses or partial responses are considered having an objective response.|Assessed every 2 cycles for the first 12 cycles, then every 3 cycles until treatment discontinuation, then every 8 weeks until disease progression or up to 5 years|Eligible, treated patients||Proportion of patients||95% Confidence Interval|Number
728199|NCT00378703|Secondary|Overall Survival|Overall survival was defined as the time from randomization to death. Patients alive at last contact were censored on the date of last contact.|Assessed every 2 cycles for the first 12 cycles, then every 3 cycles until treatment discontinuation, then every 8 weeks until disease progression or up to 5 years|Eligible, treated patients||Months||90% Confidence Interval|Median
728200|NCT00378703|Secondary|Proportion of Patients With Stable Disease at 6 Months|Patients whose date of progression was after 6 months or who were disease-free at last follow-up beyond 6 months were considered to be stable at 6 months and all other patients were not.|Assessed every 2 cycles for the first 12 cycles, then every 3 cycles until treatment discontinuation, then every 8 weeks until disease progression or up to 5 years|Eligible, treated patients||Proportion of patients||95% Confidence Interval|Number
728201|NCT00378703|Primary|Progression-free Survival (PFS)|Progression-free survival is defined as time from randomization to clinical evidence of disease progression or death from any cause without progression. Patients alive without progression were censored at the date of last disease assessment.|Assessed every 2 cycles for the first 12 cycles, then every 3 cycles until treatment discontinuation, then every 8 weeks until disease progression or up to 5 years|Eligible, treated patients||Months||90% Confidence Interval|Median
728202|NCT00378898|Secondary|Subjects Reporting Chest Pain|Edmonton Symptom Assessment is used to measure the presence and change in symptoms.|48 hours|2 subjects had to have the BRAVO removed before 48 hours due to reported discomfort in the BRAVO placement group so chest pain scores were obtained for 9 of the 11 subjects.||Participants|||Count of Participants
728203|NCT00378898|Primary|Patients Requiring Endoscopic Removal of BRAVO Because of Reported Discomfort||48 hours|||participants|||Number
728204|NCT00379080|Secondary|Protein Expression Patterns Post Treatment - Loss or Gain|"serial blood samples over multiple time points (prior to treatment, 2 days post treatment, 8 days post treatment, 10 days post treatment and 28 days post treatment.
statistical analyses presented for the comparisons that yielded a p-value <=0.05"|baseline - cycle 2 (28 days)|peripheral blood was obtained from 20 patients enrolled in the phase 2 portion of the study.||hazard ratio||95% Confidence Interval|Number
728205|NCT00379080|Secondary|Proportion of Patients With Serious or Life Threatening Toxicities|Grade 3 or 4 toxicities related to treatment as determined by the CTCAE|2 year period|||percentage of participants|||Number
728206|NCT00379080|Secondary|Overall Failure Rate (Phase II)|The overall failure rate is expressed as hazard of failure per person-year of follow-up.|up to 4 years|||failure per person-year||95% Confidence Interval|Number
728207|NCT00379080|Secondary|Six-month Progression-free Survival Rate (Phase II)|"The probability of 6-momth progression-free survival will be estimated using binomial distribution.
Progression defined as: Progressive neurological abnormalities not explained by other causes or greater than 25% increase in size of tumor or if new lesion."|At 6 months|The probability of 6-momth progression-free survival will be estimated using binomial distribution.||percent probability||95% Confidence Interval|Number
728208|NCT00379080|Secondary|Overall Survival (Phase II)|Median time of survival along with 95% confidence interval will be estimated using Kaplan-Meier method. An overall failure rate will be estimated with 95% CI.|Up to 4 years|Median time of survival along with 95% confidence interval will be estimated using Kaplan-Meier method. An overall failure rate will be estimated with 95% CI. The overall failure rate is expressed as hazard of failure per person-year of follow-up.||months||95% Confidence Interval|Median
728209|NCT00379080|Primary|Pharmacokinetics; Steady-state Trough Concentration for Tandutinib in Phase 1 and Phase 2|pre-dose, 1,2,4,6,8 and 24 hrs post dose and days 8,15, 21 of cycle 1 and day one of cycle 2|28 days|56 enrolled pts, 40 evaluable PK sample sets, parameters not estimated for 16 pts. (Sample collected after next dose taken 3pts;1st dose given before collecting redose sample 1 pt; concentration sample 24h after dosing <LOQ 8 pts or samples not collected proper times 1pt. 2pts feasibility arm did not restart treatment post-surgery||ng/mL||Standard Deviation|Median
728210|NCT00379080|Primary|Pharmacokinetics; Apparent Oral Total Body Volume of Distribution for Tandutinib in Phase 1 and Phase 2|pre-dose, 1,2,4,6,8 and 24 hrs post dose and days 8,15, 21 of cycle 1 and day one of cycle 2|28 days|56 enrolled pts, 40 evaluable PK sample sets, parameters not estimated for 16 pts. (Sample collected after next dose taken 3pts;1st dose given before collecting redose sample 1 pt; concentration sample 24h after dosing <LOQ 8 pts or samples not collected proper times 1pt. 2pts feasibility arm did not restart treatment post-surgery||L||Standard Deviation|Median
728211|NCT00379080|Primary|Pharmacokinetics; Apparent Oral Clearance for Tandutinib in Phase 1 and Phase 2|pre-dose, 1,2,4,6,8 and 24 hrs post dose and days 8,15, 21 of cycle 1 and day one of cycle 2|28 days|56 enrolled pts, 40 evaluable PK sample sets, parameters not estimated for 16 pts. (Sample collected after next dose taken 3pts;1st dose given before collecting redose sample 1 pt; concentration sample 24h after dosing <LOQ 8 pts or samples not collected proper times 1pt. 2pts feasibility arm did not restart treatment post surgery||L/h||Standard Deviation|Median
728212|NCT00379080|Primary|Pharmacokinetics (Area Under the Plasma Concentration Time Profile From Zero to Infinity (AUC)) for Tandutinib in Phase 1 and Phase 2|pre-dose, 1,2,4,6,8 and 24 hrs post dose and days 8,15, 21 of cycle 1 and day one of cycle 2|28 days|56 enrolled pts, 40 evaluable PK sample sets, parameters not estimated for 16 pts. (Sample collected after next dose taken 3pts;1st dose given before collecting redose sample 1 pt; concentration sample 24h after dosing <LOQ 8 pts or samples not collected proper times 1pt. 2pts feasibility arm did not restart treatment post-surgery||ng*h/mL||Standard Deviation|Median
728213|NCT00379080|Primary|Pharmacokinetics (Apparent Terminal Phase Half-life) for Tandutinib in Phase 1 and Phase 2|pre-dose, 1,2,4,6,8 and 24 hrs post dose and days 8,15, 21 of cycle 1 and day one of cycle 2|28 days|56 enrolled pts, 40 evaluable PK sample sets, parameters not estimated for 16 pts. (Sample collected after next dose taken 3pts;1st dose given before collecting redose sample 1 pt; concentration sample 24h after dosing <LOQ 8 pts or samples not collected proper times 1pt. 2pts feasibility arm did not restart treatment post-surgery||h||Standard Deviation|Median
728214|NCT00379080|Primary|Pharmacokinetics (Max Concentration of Plasma) for Tandutinib in Phase 1 and Phase 2|pre-dose, 1,2,4,6,8 and 24 hrs post dose and days 8,15, 21 of cycle 1 and day one of cycle 2|28 days|56 enrolled pts, 40 evaluable PK sample sets, parameters not estimated for 16 pts. (Sample collected after next dose taken 3pts;1st dose given before collecting redose sample 1 pt; concentration sample 24h after dosing <LOQ 8 pts or samples not collected proper times 1pt. 2pts feasibility arm did not restart treatment post-surgery||ng/mL||Standard Deviation|Median
728229|NCT00379236|Secondary|Mean Change From Baseline in Short Form 36 Questionnaire (SF-36) Bodily Pain(BP) Score at Week 26|The SF-36 questionnaire yields a score for each domain of health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state. This table summarizes the change from baseline in participants' bodily pain scores. The questionnaire is completed by participants.|weeks 0 and 26|Intent to treat population||units on a scale||Standard Deviation|Mean
728215|NCT00379080|Primary|Tumor Response (Complete Response and Partial Response) Rate (Phase II)|"pts receive a scan baseline and prior to every odd cycle. All responses are centrally reviewed Complete response Complete disappearance of all tumor on MRI scan, off all glucocorticoids with stable or improving neurological exam minimum of 4 wks Partial response Greater than or equal 50% reduction in tumor size on MRI, on sable or decreasing glucocorticoids with stable or improving neurological exam for a minimum of 4 wks.
Progressive disease Progressive neurological abnormalities not explained by other causes or greater than 25% increase in size of tumor or if new lesion.
Stable disease Clinical status and MRI does not qualify for complete response, partial response or progression"|Up to 4 years|In the first stage, 31 patients would be enrolled and the trial would be terminated if 3 or fewer patients demonstrated objective responses (partial response or complete response)||participants with objective response|||Number
728216|NCT00379080|Primary|Number of Dose Limiting Toxicities Per Dose Level|"cohorts of 3-6 pts will recieve oral tandutinib starting at 500mg BID with a dose escalation in each cohort. Each treatment cycle is 28 days. Evaluation period for MTD is 1st cycle - 28 days.
dose limiting toxicity defined as: grades 3-4 severity (except vomiting and diarrhea without sufficient prophylaxis delay of treatment > 14 days. ANC less/equal 500m/mm3; Plts less/equal 25,000/mm3; febrile neutropenia or delay of treatment > 14 days"|28 days|all GBM, All prior treatment with RT. assessment was for 28 days, cycle 1. 3 dose levels 500, 600 and 700mg||participants|||Number
728217|NCT00379080|Primary|To Determine the Tumor/Plasma Ratio of in Subjects With Recurrent GBM Undergoing Resections (Phase 0)|participants are administered tandutinib (500mg BID) for 7 days prior to surgery and then undergo resection for recurrent glioblastoma. Tissue samples will be collected for correlative studies - determine tumor/plasma ratio.|7 days prior to surgery including surgery|a tandutinib tumor:plasma ratio of >/=0.33 was the objective in a minimum of 3/6 subjects in order to proceed with Phase 1/2 study. 6 samples received, but 2 samples were found to be thawed at receipt and not used in analysis||ratio||Standard Deviation|Mean
728218|NCT00379080|Primary|Maximum Tolerated Dose of Tandutinib Defined by Dose Limiting Toxicities (Phase 1)||cycle 1 - 28 days|19 patients enrolled in dose escalation but 4 were removed for reasons other than drug related toxicity||mg BID|||Number
728219|NCT00379197|Secondary|Median Time to Event|First time when maximum SUV is higher than that at baseline within 1 year of study entry.|From Baseline to 1 Year|One of the 8 participants did not have an increase in SUV above baseline at 8 weeks, but no further PET scans were performed after 8 weeks. The reported median value is for the remaining 7 participants.||weeks||Full Range|Median
728220|NCT00379197|Primary|Disease Response|A response is the number of participants whose tumor demonstrated a decrease in FDG uptake (SUV) by 50% or greater in at least one of the metastatic sites as measured by PET imaging at the end of 4 weeks of treatment compared to baseline.|Week 4|||participants|||Number
728221|NCT00379210|Primary|Reaction Times on the Sustained Attention to Response Task.|Single digits (0-9) are flashed on the screen one by one. The number 3 is the target and all other digits are non-targets. The participant is asked to press the space bar for nontargets and withhold from pressing the space bar for the target.|9 weeks|||milliseconds||Standard Deviation|Mean
728222|NCT00379236|Secondary|Change From Baseline (Extension Study Week 26) in Use of Rescue Medication at Week 52.|The change in the number of tablets of study-specific acetaminophen taken per week as a rescue medication from knee pain.|Extension baseline (week 26 pre-dose), week 52|Intent to treat population||tablets per week||Standard Deviation|Mean
728223|NCT00379236|Secondary|Number of Observed Osteoarthritis Research Society International (OARSI30) Responders Using the 50-Foot Walk Test at Week 52|Responders are identified based on a calculation of three scales: 50-foot walk test for pain, function and global assessment scales. Each of the individual scales was completed by the participant. A participant was a responder (answer:YES) if there was high improvement in pain or function (>=50 percent and absolute change of >=20 millimeters), or improvement in at least two of three categories: Pain and/or Function and/or Patient Global Assessment scales of >=20 percent and absolute change >=10 millimeter.|Week 52 (Extension Study)|Intent to treat population.||participants|||Number
728224|NCT00379236|Secondary|Mean Change From Baseline in Observed Pain Scores on 50-foot Walk Test During the Extension Study|The mean difference in participant pain as measured by participants during a walk of 50 feet in length between the baseline (week 26 pre-dose) and week 52 scores. Scores are measured on a visual analog scale of 100 millimeters, with a score of 0 millimeters meaning there was no pain observed; a score of 100 millimeters meaning extreme pain was observed.|Extension baseline (week 26), week 52|Intent to treat population. No imputation for missing values.||units on a scale||Standard Deviation|Mean
728225|NCT00379236|Secondary|Observed Pain Scores on the 50-foot Walk Test During the Extension Study|Participant pain during a walk of 50 feet in length was evaluated by participants on a 100 millimeter visual analog scale. A score of 0 millimeters means there was no pain observed; a score of 100 millimeters means extreme pain was observed.|Baseline (week 26), week 52|Intent to treat population. No imputation for missing values.||units on a scale||Standard Deviation|Mean
728226|NCT00379236|Secondary|Number of Participants With 20 Millimeter or Greater Improvement in Pain Scores on the 50-foot Walk Test|Yes represents the number of participants whose pain during a walk of 50 feet in length was improved at week 26 over baseline by at least 20 millimeters. Pain was evaluated on a 100 millimeter visual analog scale by participants. A score of 0 millimeters means there was no pain observed; a score of 100 millimeters means extreme pain was observed.|Weeks 0 and 26|Intent to treat population||participants|||Number
728227|NCT00379236|Secondary|Mean Change From Baseline in Short Form 36 Questionnaire (SF-36) Physical Component Summary (PCS) Score at Week 26|The SF-36 questionnaire yields a score for each domain of health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state. The questionnaire is completed by participants. This table summarizes the change from baseline in participants' physical health.|Weeks 0, 26|Intent to treat population||units on a scale||Standard Deviation|Mean
728228|NCT00379236|Secondary|Mean Change From Baseline in Short Form 36 Questionnaire (SF-36) General Health(GH) Score at Week 26|The SF-36 questionnaire yields a score for each domain of health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state. This table summarizes the change from baseline in participants' general health scores. The questionnaire is completed by participants.|weeks 0 and 26|Intent to treat population||units on a scale||Standard Deviation|Mean
728230|NCT00379236|Secondary|Mean Change From Baseline in Short Form 36 Questionnaire (SF-36) Physical Function (PF) Score at Week 26|The SF-36 questionnaire yields a score for each domain of health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state. This table summarizes the change from baseline in participants' physical function. The questionnaire is completed by participants.|Weeks 0, 26|Intent to treat population||units on a scale||Standard Deviation|Mean
728231|NCT00379236|Secondary|Change From Baseline in the Number of Tablets of Rescue Medication Used at Week 26.|The change in the number of tablets of 500 milligram acetaminophen used in a week as rescue medication is compared at weeks 0 and weeks 26.|Weeks 0 and 26|Intent to treat population||tablets per week||Standard Deviation|Mean
728232|NCT00379236|Secondary|Change From Baseline in Patient Global Assessment of Knee Pain at Week 26|Participant assessment of knee pain evaluated on a 100 millimeter visual analog scale. A score of 0 millimeters means there was no pain; a score of 100 millimeters means extreme pain.|Weeks 0 and 26|Intent to treat population||units on a scale||Standard Deviation|Mean
728233|NCT00379236|Primary|Shifts From Extension Study Baseline (Week 26) in Ratings of Knee Redness at Week 52|Number of participants in various categories of target knee joint examination findings from baseline (week 26 pre-injection) to week 52. Redness of the knee was subjectively rated as Yes (knee was red) and No (knee was not red).|weeks 26 and 52|Safety population which includes all participants who received at least one injection during the extension phase of the study.||participants|||Number
728234|NCT00379236|Primary|Shifts From Extension Study Baseline (Week 26) in Ratings of Knee Local Warmth at Week 52|Number of participants in various categories of target knee joint examination findings from baseline (week 26 pre-injection) to week 52. Local warmth of the target knee was recorded as Yes (warmth present) or No (knee was not warmer than expected).|weeks 26 and 52|Safety population which includes all participants who received at least one injection during the extension phase of the study.||participants|||Number
728235|NCT00379236|Primary|Shifts From Extension Study Baseline (Week 26) in Ratings of Knee Tenderness at Week 52|Number of participants in various categories of target knee joint examination findings from baseline (week 26 pre-injection) to week 52. Tenderness of the knee was subjectively rated by participants as none, mild, moderate or severe.|weeks 26 and 52|Safety population which includes all participants who received at least one injection during the extension phase of the study.||participants|||Number
728236|NCT00379236|Primary|Shifts From Extension Study Baseline (Week 26) in Range of Motion Findings at Week 52|Number of participants in various categories of target knee joint examination findings from baseline (week 26 pre-injection) to week 52. Range of motion indicates the flexibility of the knee, and is measured by the number of degrees between when the knee is hyper-extended and when the knee is flexed.|weeks 26 and 52|Safety population which includes all participants who received at least one injection during the extension phase of the study.||participants|||Number
728237|NCT00379236|Primary|Percent Change From Baseline in Observed Pain Scores on 50-foot Walk Test During the Double-blind Study|The percent difference in participant pain recorded by the participant during a walk of 50 feet in length between the baseline (week 0) and week 26 scores. Scores are measured on a visual analog scale of 100 millimeters; a score of 0 millimeters meaning no pain was observed; a score of 100 millimeters meaning extreme pain was observed.|Weeks 0 and 26|Intent to treat population.||percent change from baseline value||Standard Deviation|Mean
728238|NCT00379236|Secondary|Number of Observed Osteoarthritis Research Society International (OARSI30) Responders Using the Western Ontario McMaster University Osteoarthritis Index (WOMAC A) Pain Scale at Week 26|Responders are identified based on a calculation of three scales: WOMAC (A) pain, function and global assessment scales. Each of the individual scales was completed by the participant. A participant was a responder (answer: YES) if there was high improvement in pain or function (>=50 percent and absolute change of >=20 millimeters), or improvement in at least two of three categories: Pain and/or Function and/or Patient Global Assessment scales of >=20 percent and absolute change >=10 millimeter.|week 26|Intent to treat population||participants|||Number
728239|NCT00379236|Secondary|Number of Observed Osteoarthritis Research Society International (OARSI30) Responders Using the Western Ontario McMaster University Osteoarthritis Index (WOMAC A) Pain Scale at Week 12|Responders are identified based on a calculation of three scales: WOMAC (A) pain, function and global assessment scales. Each of the individual scales was completed by the participant. A participant was a responder (answer: YES) if there was high improvement in pain or function (>=50 percent and absolute change of >=20 millimeters), or improvement in at least two of three categories: Pain and/or Function and/or Patient Global Assessment scales of >=20 percent and absolute change >=10 millimeter.|Week 12|Intent to treat population||participants|||Number
728240|NCT00379236|Secondary|Number of Observed Osteoarthritis Research Society International (OARSI30) Responders Using the 50-Foot Walk Test at Week 26|Responders are identified based on a calculation of three scales: 50-foot walk test for pain, function and global assessment scales. Each of the individual scales was completed by the participant. A participant was a responder (answer: YES) if there was high improvement in pain or function (>=50 percent and absolute change of >=20 millimeters), or improvement in at least two of three categories: Pain and/or Function and/or Patient Global Assessment scales of >=20 percent and absolute change >=10 millimeter.|Week 26|Intent to treat population||participants|||Number
728241|NCT00379236|Secondary|Number of Observed Osteoarthritis Research Society International (OARSI30) Responders Using the 50-Foot Walk Test at Week 12|Responders are identified based on a calculation of three scales: 50-foot walk test for pain, function and global assessment scales. Each of the individual scales was completed by the participant. A participant was a responder (answer: YES) if there was high improvement in pain or function (>=50 percent and absolute change of >=20 millimeters), or improvement in at least two of three categories: Pain and/or Function and/or Patient Global Assessment scales of >=20 percent and absolute change >=10 millimeter.|Week 12|Intent to treat population||participants|||Number
728257|NCT00379353|Secondary|Functional Assessment of Anorexia/Cachexia Therapy (FAACT)|12-item symptom-specific subscale of the FACT-G designed to measure participants' additional concerns about their anorexia/cachexia during the previous 7 days. Participant rates concerns from 0 to 4 (0= not at all, 4= very much), combined are the 12 items subscales for a total of 0 to 48 where the higher number would represent greater concern.|Baseline to Day 29|||units on a scale||Full Range|Median
728258|NCT00379574|Secondary|Number of Patients Who Experienced Adverse Events||6 months|||participants|||Number
728242|NCT00379236|Secondary|Percent Change From Baseline in Observed Pain Scores on 50-foot Walk Test During the Double-blind Study for a Subpopulation of Participants With More Severe Knee Pain|Percent difference in participant pain during a walk of 50 feet in length between the mean screening (week -1) and baseline(week 0) scores, and week 26 scores. Scores are recorded by participants and measured on a visual analog scale of 100 millimeters, with 0 millimeters meaning there was no pain observed; 100 millimeters meaning extreme pain was observed.|weeks -1, 0, and 26|Intent to treat population. A subpopulation of patients with more severe knee pain, as measured by having a greater than or equal to 41 millimeter screening score on the 50-foot walk test.||percentage change from baseline score||Standard Deviation|Mean
728243|NCT00379236|Secondary|Percent Change From Screening in Observed Pain Scores on 50-foot Walk Test During the Double-blind Study|The percent difference in participant pain recorded by the participant during a walk of 50 feet in length between the screening (week -1) and week 26 scores. Scores are measured on a visual analog scale of 100 millimeters; a score of 0 millimeters means there was no pain observed; a score of 100 millimeters means extreme pain was observed.|weeks -1 and 26|Intent to treat population||percent change from screening value||Standard Deviation|Mean
728244|NCT00379236|Primary|Observed Pain Scores on 50-foot Walk Test During the Double-blind Study|The level of pain is estimated by the participant following a walk of 50 feet in length which is observed by the investigator. Pain estimates were evaluated on a 100 millimeter visual analog scale. A score of 0 millimeters means there was no pain observed; a score of 100 millimeters means extreme pain was observed.|Weeks 0, 26|Intent to treat (ITT) population.||units on a scale||Standard Deviation|Mean
728245|NCT00379288|Primary|The Number of All Randomized Subjects Reporting Adverse Events (AEs).|AEs that are considered Related, Severe, and Serious, as determined by the investigator and using specific criteria defined in the protocol, are included in the primary results.|1 year|||participants|||Number
728246|NCT00379340|Secondary|Event Free Survival Associated With the Burden of Pulmonary Metastatic Disease|Probability of no relapse, secondary malignancy, or death after 4 year in the study.|At 4 years|Analysis population is eligible stage (stg) IV patients (pts) with lung mets only. On Participant Flow table, these pts include 120 RCR, 135 SIR, 21 stg IV with LOH (of 52 when including stg III), and 23 stg IV with lung mets (off therapy before week 6). A total of 299 stg IV pts, exceeding the total number of participant (297) analyzed for OM 4.||Probability||95% Confidence Interval|Number
728247|NCT00379340|Primary|Event Free Survival Probability|Probability of no relapse, secondary malignancy, or death after 4 year in the study|At 4 years|All eligible patients were included in this analysis.||Probability of EFS at 4 years||95% Confidence Interval|Number
728248|NCT00379340|Primary|Event Free Survival (EFS) Probability|Probability of no relapse, secondary malignancy, or death after 4 year in the study.|At 4 years|Analysis includes only eligible patients.||Probability of EFS at 4 years||95% Confidence Interval|Number
728249|NCT00379340|Primary|Event Free Survival Probability|Probability of no relapse, secondary malignancy, or death after 4 year in the study.|4 years|||Probability||95% Confidence Interval|Number
728250|NCT00379353|Secondary|Change in Serum Cytokines and Receptors|Cytokines Levels of IL-1β and its receptor IL RA, IL-6 its receptor IL-6R, and TNF-α and its receptors (i.e. tumor necrosis factor receptor (TNFR)) of TNFR1, TNFR2, IL-10, IL-8(serum) measured at baseline, Days 15 and 29. Multiplex bead Immunoassay used to measure serum/plasma levels of IL-1, IL-6, TNF-α, IL-10, IL-8 and their receptors where assay sensitivity for the cytokines was 3-6 pg/mL. Serum IL-10, IL-1β, IL-1RA, IL-6R, sTNF-RI, sTNF-R2 were also analyzed using an enzyme-linked immunosorbent assay device. Lowering cytokine levels can decrease fatigue, increase appetite and decrease anxiety and depression.|Baseline to Day 15|||pg/mL||Inter-Quartile Range|Median
728251|NCT00379353|Secondary|Change in Body Composition as Measured by Body Mass Index (BMI)|BMI, commonly used to measure overweight and obesity, is a measure of body fat based on a person's weight and height.|Baseline to Day 29|||kg/m^2||Full Range|Median
728252|NCT00379353|Primary|Change in Symptoms as Measured by Edmonton Symptom Assessment Scale (ESAS)|ESAS assessment of appetite (symptom) where the severity at the time of assessment is rated from 0 to 10 on a numerical scale; with 0 meaning that the symptom is absent and 10 that it is the worst possible severity. Evaluated at baseline [± 3 days], 2 weeks[± 3 days] and 4 weeks [± 3 days]|Baseline to Day 29|||units on a scale||Full Range|Median
728253|NCT00379353|Secondary|Pittsburgh Sleep Quality Index (PSQI)|PSQI measures the quality and patterns of sleep. It differentiates poor from good sleep by measuring subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. A participant indicates how frequently each item was experienced on a scale from 0 to 3. The 7 component scores are then summed to obtain a global sleep score that can range from 0 to 21. A score of >/= 5 indicates poor sleepers.|Baseline to Day 29|||units on a scale||Full Range|Median
728254|NCT00379353|Secondary|Hospital Anxiety and Depression Scale (HADS) HADS-D (Depression)|The HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0–3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0–21). The higher the score, the more likely the patient is showing signs of depression and as a result may benefit from a counseling/supportive session.|Baseline to Day 29|||units on a scale||Full Range|Median
728255|NCT00379353|Secondary|Hospital Anxiety and Depression Scale (HADS) HADS-A (Anxiety)|The HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0–3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0–21). The higher the score The higher the score, the more likely the patient is showing signs of anxiety and as a result may benefit from a counseling/supportive session.|Baseline to Day 29|||units on a scale||Full Range|Median
728256|NCT00379353|Secondary|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)|The FACIT-F consists of 27 general quality of life questions divided into 4 domains (physical, social, emotional and functional), plus a 13-item fatigue subscore. The participant rates the intensity of fatigue and its related symptoms on a scale of 0-4 (0= not at all, 4= very much) where the 13-item fatigue subscore totals are combined for a total of 0 to 52, with the higher number representing greater fatigue.|Baseline to Day 29|||units on a scale||Full Range|Median
728264|NCT00379639|Primary|Best Overall Response|"Disease response was determined by the Investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria using computed tomography or magnetic resonance imaging:
Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions or the appearance of ≥1 new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD."|Disease assessments were performed within 4 weeks of first dose and every 8 weeks thereafter (up to 236 days).|The Efficacy Evaluable (EE) population consisted of all patients who completed at least 2 consecutive cycles of treatment, had at least 1 post-Baseline efficacy assessment performed, and did not have any major protocol violations.||participants|||Number
728265|NCT00379639|Primary|Number of Participants With Adverse Events (AEs)|"AEs were graded for severity according to the National Cancer Institute Common Terminology Criteria (NCI CTCAE), V 3.0: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe (prevents normal everyday activities); Grade 4: Life-threatening or disabling; Grade 5: Death.
A serious AE is associated with events that pose a threat to a patient’s life or functioning, require hospitalization, is a congenital anomaly/birth defect or is an important medical event or condition that may jeopardize the patient and may require medical or surgical intervention to prevent one of the above outcomes."|From the date of first dose to 30 days after last dose (up to 236 days).|Safety population.||participants|||Number
728266|NCT00379639|Primary|Number of Participants With a Dose-limiting Toxicity (DLT)|"Toxicities were assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), V 3.0. A DLT was one of the following, if considered at least possibly related to study treatment:
Grade 4 neutropenia for ≥5 days or febrile neutropenia; Grade 4 thrombocytopenia or need for a platelet transfusion; ≥ Grade 3 nausea and/or emesis despite using optimal antiemetic therapy; ≥ Grade 3 diarrhea despite using maximal supportive therapy; Any clinically significant Grade 3 or 4 nonhematologic toxicity; Inability to administer all doses in cycle 1."|28 days|Safety population - all participants who received at least one dose of study drug.||participants|||Number
728267|NCT00379769|Secondary|Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up|The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.|From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)|Observational Follow-up Population: all participants from the ITT Population of the RECORD study who provided data during the observational follow-up. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).||participants|||Number
728268|NCT00379769|Secondary|Number of Bone Fracture Events With the Indicated Outcome: Observational Follow-up|"The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The indicated fracture outcome was pre-specified in the CRF and included Unknown as a category. Fracture events with missing outcome data were reported as Data unavailable."|From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)|Observational Follow-up Population: all participants from the ITT Population of the RECORD study who provided data during the observational follow-up. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).||bone fracture events|||Number
728269|NCT00379769|Secondary|Number of Bone Fracture Events With the Indicated Outcome: Main Study + Observational Follow-up Combined|"The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The indicated fracture outcome was pre-specified in the CRF and included Unknown as a category. Fracture events with missing outcome data were reported as Data unavailable."|From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)|ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).||bone fracture events|||Number
728270|NCT00379769|Secondary|Number of Participants With Bone Fracture Events of the Indicated Cause: Observational Follow-up|"The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The indicated fracture outcome was pre-specified in the CRF and included Unknown as a category. Fracture events with missing outcome data were reported as Data unavailable."|From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)|Observational Follow-up Population: all participants from the ITT Population of the RECORD study who provided data during the observational follow-up. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).||participants|||Number
728271|NCT00379769|Secondary|Number of Participants With Bone Fracture Events of the Indicated Cause: Main Study + Observational Follow-up Combined|The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant.|From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)|ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).||participants|||Number
728272|NCT00379769|Secondary|Number of Participants With Potentially High Morbidity Fracture Events and Non-high Morbidity Fracture Events, in Participants With Prior Hand/Upper Arm/Foot Fractures (H/UA/FF): Main Study + Observational Follow-up Combined|The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The following bone fractures were grouped and were identified as potentially high morbidity bone fractures: hip, pelvis, upper leg, vertebral (lumbar spine, thoracic spine, cervical spine, spine - site unknown).|From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)|ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).||participants|||Number
728273|NCT00379769|Secondary|Number of Participants With Potentially High Morbidity Fractures: Main Study + Observational Follow-up Combined|The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The following bone fractures were grouped and were identified as potentially high morbidity bone fractures: hip, pelvis, upper leg, vertebral (lumbar spine, thoracic spine, cervical spine, spine - site unknown).|From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)|ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).||participants|||Number
728274|NCT00379769|Secondary|Number of Participants With the Indicated Bone Fracture by Fracture Site: Observational Follow-up|The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date that had the same Higher Level Group Term (HLGT) for fracture location, per participant.|From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)|Observational Follow-up Population: all participants from the ITT Population of the RECORD study who provided data during the observational follow-up. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).||participants|||Number
728275|NCT00379769|Secondary|Number of Participants With the Indicated Bone Fracture by Fracture Site: Main Study + Observational Follow-up Combined|The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date that had the same Higher Level Group Term (HLGT) for fracture location, per participant.|From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)|ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).||participants|||Number
728276|NCT00379769|Secondary|Number of Participants With an Event of Death Due to a Bone Fracture-related Event: Main Study + Observational Follow-up Combined|The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant.|From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)|ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).||participants|||Number
728287|NCT00379769|Primary|Independent Re-adjudication Outcome: Number of Participants With an Event of Stroke (Fatal and Non-fatal), Based on Contemporary Endpoint Definitions|The number of participants with a stroke (fatal or non-fatal) event as determined by independent re-adjudication using the Standard Data Collection for Cardiovascular Trials Initiative (draft October 2011) endpoint definitions was recorded. An event of stroke was defined as an acute episode of neurological dysfunction caused by focal or global brain, spinal cord, or retinal vascular injury.|Baseline through End of Study (up to 7.5 years)|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication||participants|||Number
728435|NCT00380250|Secondary|Month 2 Symptom Relief|Significantly worse = -3; Moderately worse = -2; A little bit worse = -1; Unchanged = 0; A little bit relieved=1; Moderately relieved=2; Significantly relieved = 3|Change from baseline for month 2|ITT with LOCF||Scale score||Standard Deviation|Mean
728277|NCT00379769|Secondary|Number of Participants With a Bone Fracture Event Reported as the Indicated Serious Adverse Event (by Higher Level Group Term) or Death: Observational Follow-up|The OFU was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the OFU. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.|From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)|Observational Follow-up Population: all participants from the ITT Population of the RECORD study who provided data during the observational follow-up. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).||participants|||Number
728278|NCT00379769|Secondary|Number of Participants With a Bone Fracture Event Reported as the Indicated Serious Adverse Event (by Higher Level Group Term) or Death: Main Study + Observational Follow-up Combined|The OFU was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the OFU. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.|From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)|ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).||participants|||Number
728279|NCT00379769|Secondary|Number of Participants With a Bone Fracture Event – Overall and by Gender: Observational Follow-up|The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant.|From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)|Observational Follow-up Population: all participants from the ITT Population of the RECORD study who provided data during the observational follow-up. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).||participants|||Number
728280|NCT00379769|Secondary|Number of Participants With a Bone Fracture Event – Overall and by Gender: Main Study and Observational Follow-up Combined|The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant.|From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)|ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).||participants|||Number
728281|NCT00379769|Secondary|Number of Participants Who Died Due to the Indicated Cancer-related Event: Observational Follow-up|The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.|From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)|Observational Follow-up Population: all participants from the ITT Population of the RECORD study who provided data during the observational follow-up. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).||participants|||Number
728288|NCT00379769|Primary|Independent Re-adjudication Outcome: Number of Participants (Par.) With an Event of Stroke (Fatal and Non-fatal), Based on Original RECORD Endpoint Definitions|Par. with a stroke (fatal or non-fatal) event as determined by independent re-adjudication using the original RECORD endpoint definitions was recorded. A stroke event=hospitalization plus rapidly developed clinical signs of focal (or global) disturbance of cerebral function lasting more than 24 hours (unless interrupted by thrombolysis, surgery, or death), with no apparent cause other than a vascular origin, including par. presenting clinical signs/symptoms suggestive of subarachnoid haemorrhage/intracerebral haemorrhage/cerebral ischemic necrosis or cause of death adjudicated as stroke.|Baseline through End of Study (up to 7.5 years)|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication||participants|||Number
728282|NCT00379769|Secondary|Number of Participants Who Died Due to the Indicated Cancer-related Event: Main Study + Observational Follow-up Combined|The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.|From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)|ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).||participants|||Number
728283|NCT00379769|Secondary|Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Observational Follow-up|The observational follow-up (OFU) was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the OFU. The neoplasms/cancer events of bladder, breast, colon, liver, pancreatic, prostate cancer, and melanoma were pre-specified as cancers of interest for the OFU. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.|From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)|Observational Follow-up Population: all participants from the ITT Population of the RECORD study who provided data during the observational follow-up. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).||participants|||Number
728284|NCT00379769|Secondary|Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Main Study + Observational Follow-up Combined|The observational follow-up (OFU) was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the OFU. The neoplasms/cancer events of bladder, breast, colon, liver, pancreatic, prostate cancer, and melanoma were pre-specified as cancers of interest for the OFU. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.|From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)|ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).||participants|||Number
728285|NCT00379769|Secondary|Number of Participants With the Indicated Type of Neoplasm/Cancer Event Reported as a Serious Adverse Event (SAE) or Death: Observational Follow-up|The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.|From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)|Observational Follow-up Population: all participants from the ITT Population of the RECORD study who provided data during the observational follow-up. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).||participants|||Number
728286|NCT00379769|Secondary|Number of Participants With the Indicated Type of Neoplasm/Cancer Event Reported as a Serious Adverse Event (SAE) or Death: Main Study + Observational Follow-up Combined|The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.|From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)|ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).||participants|||Number
728289|NCT00379769|Primary|Independent Re-adjudication Outcome: Number of Participants With an Event of Myocardial Infarction (Fatal and Non-fatal), Based on Contemporary Endpoint Definitions|The number of participants with an MI (fatal or non-fatal) event as determined by independent re-adjudication using the Standard Data Collection for Cardiovascular Trials Initiative (draft October 2011) endpoint definitions was recorded. An event of MI was defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.|Baseline through End of Study (up to 7.5 years)|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication||participants|||Number
728290|NCT00379769|Primary|Independent Re-adjudication Outcome: Number of Participants With an Event of Myocardial Infarction (Fatal and Non-fatal), Based on Original RECORD Endpoint Definitions|The number of participants with an MI (fatal or non-fatal) event as determined by independent re-adjudication using the original RECORD endpoint definitions was recorded. An event of MI was defined as hospitalization plus elevation of cardiac biomarkers troponin (TN) I and/or TNT above the upper limit of normal (ULN) or creatinine kinase (CK) MB (M=muscle type; B=brain type) isoenzyme >= 2x the ULN or CK > 2x the ULN plus typical symptoms of cardiac ischemia or new pathological electrocardiogram findings, or cause of death adjudicated as MI.|Baseline through End of Study (up to 7.5 years)|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication||participants|||Number
728291|NCT00379769|Primary|Independent Re-adjudication Outcome: Number of Participants With a CV (or Unknown) Death, Based on Contemporary Endpoint Definitions|The number of participants with a CV (or unknown) death as determined by independent re-adjudication using the Standard Data Collection for Cardiovascular Trials Initiative (draft October 2011) endpoint definitions was recorded. CV death included death resulting from an acute myocardial infarction (MI), sudden cardiac death, death due to heart failure, death due to stroke, and death due to other CV causes. Deaths of unknown cause were counted as CV deaths.|Baseline through End of Study (up to 7.5 years)|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication||participants|||Number
728292|NCT00379769|Primary|Independent Re-adjudication Outcome: Number of Participants With a CV (or Unknown) Death, Based on Original RECORD Endpoint Definitions|"The number of participants with a CV death (or unknown) as determined by independent re-adjudication using the original RECORD endpoint definitions was recorded. CV death was defined as any death for which an unequivocal non-CV cause could not be established. CV death included death following heart failure, death following acute myocardial infarction (MI), sudden death, death due to acute vascular events, and other CV causes. Deaths due to unknown causes were classified as unknown deaths, but were counted as CV deaths for the analysis of this endpoint."|Baseline through End of Study (up to 7.5 years)|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication||participants|||Number
728293|NCT00379769|Primary|Independent Re-adjudication Outcome: Number of Participants With a First Occurrence of a Major Adverse Cardiovascular Event (MACE) Defined as CV (or Unknown) Death, Non-fatal MI, and Non-fatal Stroke Based on Contemporary Endpoint Definitions|Independent re-adjudication was based on the Standard Data Collection for Cardiovascular Trials Initiative (draft October 2011) endpoint definitions. CV death included death resulting from an acute MI; sudden cardiac death and death due to heart failure, stroke, and to other CV causes. Deaths of unknown cause were counted as CV deaths. MI was defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Stroke was defined as an acute episode of neurological dysfunction caused by focal or global brain, spinal cord, or retinal vascular injury.|Baseline through End of Study (up to 7.5 years)|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication||participants|||Number
728294|NCT00379769|Primary|Independent Re-adjudication (IR) Outcome: Number of Participants With a First Occurrence of a Major Adverse Cardiovascular Event (MACE) Defined as CV (or Unknown) Death, Non-fatal MI, and Non-fatal Stroke Based on Original RECORD Endpoint Definitions|IR was based on original RECORD endpoint definitions. CV death= no unequivocal non-CV cause (sudden death, death from acute vascular events, heart failure, acute MI, other CV causes, and deaths adjudicated as unknown cause). MI event=hospitalization + elevation of specific cardiac biomarkers above the upper limit of normal + cardiac ischemia symptoms/new pathological electrocardiogram findings. Stroke event=hospitalization + rapidly developed clinical signs of focal/global disturbance of cerebral function for more than 24 hours, with no apparent cause other than a vascular origin.|Baseline through End of Study (up to 7.5 years)|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication||participants|||Number
728295|NCT00379769|Primary|Independent Re-adjudication Outcome: Number of Participants Who Died Due to Any Cause|All deaths identified during the original record study and discovered after the re-adjudication efforts began were included.|Baseline through End of Study (up to 7.5 years)|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication||participants|||Number
728296|NCT00379769|Secondary|Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Plasminogen Activator Inhibitor-1 (PAI-1) Antigen at Month 60|The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in plasminogen activator inhibitor-1 (PAI-1) antigen was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).|Baseline to Month 60 of the randomised dual therapy treatment phase|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication||percent change||95% Confidence Interval|Geometric Mean
728297|NCT00379769|Secondary|Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Fibrinogen at Month 60|The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in fibrinogen was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).|Baseline to Month 60 of the randomised dual therapy treatment phase|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication||percent change||95% Confidence Interval|Geometric Mean
728298|NCT00379769|Secondary|Model Adjusted Ratio to Baseline (Expressed as a Percentage) for C-Reactive Protein at Month 60|The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in C-Reactive Protein was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).|Baseline to Month 60 of the randomised dual therapy treatment phase|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication||percent change||95% Confidence Interval|Geometric Mean
728299|NCT00379769|Secondary|Model Adjusted Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Month 60|Model adjusted (adjusted for any imbalances in the baseline values between within treatment groups) change from baseline in SBP and DBP was calculated as the value at Month 60 minus the Baseline value.|Baseline to Month 60 of the randomised dual therapy treatment phase|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication||mmHg (millimeters of mercury)||Standard Error|Mean
728300|NCT00379769|Secondary|Model Adjusted Change From Baseline in Waist Circumference at Month 60|Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in waist circumference was calculated as the value at Month 60 minus the Baseline value.|Baseline to Month 60 of the randomised dual therapy treatment phase|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication||cm (centimeters)||Standard Error|Mean
728301|NCT00379769|Secondary|Model Adjusted Change From Baseline in Alanine Aminotransferase at Month 60|Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in alanine aminotransferase was calculated as the value at Month 60 minus the Baseline value.|Baseline to Month 60 of the randomised dual therapy treatment phase|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication||U/L (Units/Liter)||95% Confidence Interval|Mean
728302|NCT00379769|Secondary|Model Adjusted Change From Baseline in Body Weight at Month 60|Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in body weight was calculated as the value at Month 60 minus the Baseline value.|Baseline to Month 60 of the randomised dual therapy treatment phase|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication||kilograms||Standard Error|Mean
728303|NCT00379769|Secondary|Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Urinary Albumin Creatinine Ratio at Month 60|The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in urinary albumin creatinine ratio was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).|Baseline to Month 60 of the randomised dual therapy treatment phase|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication||percent change||95% Confidence Interval|Geometric Mean
728304|NCT00379769|Secondary|Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Apolipoprotein B (Apo-B) at Month 60|The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in Apo-B was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).|Baseline to Month 60 of the randomised dual therapy treatment period|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication||percent change||95% Confidence Interval|Geometric Mean
728305|NCT00379769|Secondary|Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Total Cholesterol (TC):High-density Lipoprotein (HDL) Cholesterol and Low-density Lipoprotein (LDL) Cholesterol:HDL Cholesterol Ratios at Month 60|The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in TC:HDL cholesterol and LDL cholesterol:HDL cholesterol was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).|Baseline to Month 60 of the randomised dual therapy treatment period|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication||percent change||95% Confidence Interval|Geometric Mean
728306|NCT00379769|Secondary|Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Total Cholesterol (TC), Low-density Lipoprotein (LDL) Cholesterol, High-density Lipoprotein (HDL) Cholesterol, Triglycerides, and Free Fatty Acids (FFAs) at Month 60|The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in TC, LDL cholesterol, HDL cholesterol, triglycerides, and FFAs was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).|Baseline to Month 60 of the randomised dual therapy treatment phase|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication||percent change||95% Confidence Interval|Geometric Mean
728307|NCT00379769|Secondary|Model Adjusted Ratio to Baseline (Expressed as a Percentage) Homeostasis Model Assessment (HOMA) Beta Cell Function and Insulin Sensitivity at Month 60|The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in HOMA beta-cell function and insulin sensitivity was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).|Baseline to Month 60 of the randomised dual therapy treatment phase|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication||percent change||95% Confidence Interval|Geometric Mean
728308|NCT00379769|Secondary|Number of HbA1c and Fasting Plasma Glucose (FPG) Responders at Month 60|Number of responders, i.e., participants meeting glycaemic targets (HbA1c less than or equal to 7 percent, FPG less than or equal to 7 mmol/L)|Baseline to Month 60 of the randomised dual therapy treatment period|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication||participants|||Number
728309|NCT00379769|Secondary|Model Adjusted Mean Change From Baseline in Insulin and Pro-insulin at Month 60|Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in insulin and pro-insulin was calculated as the value at Month 60 minus the Baseline value.|Baseline to Month 60 of the randomised dual therapy treatment period|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication||picamoles/liter (pmol/L)||Standard Error|Mean
728310|NCT00379769|Secondary|Model Adjusted Change From Baseline in Fasting Plasma Glucose at Month 60|Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in fasting plasma glucose was calculated as the value at Month 60 minus the Baseline value.|Baseline to Month 60 of the randomised dual therapy treatment period|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication||mmol/L (millimoles/Liter)||Standard Error|Mean
728311|NCT00379769|Secondary|Model Adjusted Change From Baseline in HbA1c at Month 60|Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in HbA1c was calculated as the value at Month 60 minus the Baseline value.|Baseline and Month 60 of randomised dual therapy treatment period|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication||Percent||Standard Error|Mean
728312|NCT00379769|Secondary|The Number of Participants Starting Insulin at Any Time During the Study|The number of participants starting insulin at any time during the study was recorded.|Baseline through End of Study (up to 7.5 years)|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication||participants|||Number
728313|NCT00379769|Secondary|Number of Participants With Addition of Third Oral Agent/Switch to Insulin|The number of participants with addition of a third oral agent or switch to insulin from randomised dual combination treatment were recorded.|Baseline through End of Study (up to 7.5 years)|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication||participants|||Number
728314|NCT00379769|Secondary|Number of Participants With Glycaemic Failure Events|Failure of glycaemic control was defined as two consecutive HbA1c values of ≥8.5 percent, or HbA1c ≥8.5percent at a single visit, after which the subject was either moved to the post-randomised treatment phase or triple therapy was started.|Baseline through to end of randomised dual therapy|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication||participants|||Number
728315|NCT00379769|Secondary|Number of Participants With CV/Microvascular Events|The number of participants with first cardiovascular or microvascular events (renal, foot, eye) were recorded.|Baseline through End of Study (up to 7.5 years)|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication||participants|||Number
728316|NCT00379769|Secondary|Number of Participants With First Cardiovascular Hospitalisations/Cardiovascular Deaths by Stratum|Participants with first cardiovascular death (death due to cardiovascular causes or deaths with insufficient information to rule out a cardiovascular cause) and cardiovascular hospitalisation (hospitalisation for a cardiovascular event, excluding planned admissions not associated with a worsening of the disease/condition of the participant) were recorded by study stratum.|Baseline through End of Study (up to 7.5 years)|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication||partcipants|||Number
728317|NCT00379769|Secondary|Total Number of Cardiovascular Hospitalisations and Cardiovascular Deaths|The total number of events for individual components of cardiovascular (CV) hospitalisations and cardiovascular deaths were recorded. MI, myocardial infarction.|Baseline through End of Study (up to 7.5 years)|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication||Number of events|||Number
728318|NCT00379769|Secondary|Number of Participants With Cardiovascular Events and All-cause Deaths|Composites of participants with first cardiovascular (CV) hospitalisations and CV death or all-cause death and individual first events of acute myocardial infarction (MI) , stroke, congestive heart failure (CHF), CV death, and all-cause death.|Baseline through End of Study (up to 7.5 years)|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication||participants|||Number
728319|NCT00379769|Primary|Number of Participants With Cardiovascular Death/Cardiovascular Hospitalisation Events|The number of participants with cardiovascular death events (death due to cardiovascular causes or deaths with insufficient information to rule out a cardiovascular cause) and cardiovascular hospitalisation events (hospitalisation for a cardiovascular event, excluding planned admissions not associated with a worsening of the disease/condition of the participant) was recorded.|Baseline through End of Study (up to 7.5 years)|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication||participants|||Number
728320|NCT00379795|Primary|Number of Participants With Positive Serum Antibodies to Ranibizumab at Month 12 and Month 24|Serum samples for the evaluation of antibodies to Ranibizumab were collected at Month 12 and Month 24 and were sent to a reference laboratory for analysis. If an injection of Ranibizumab was required at the visit, the samples were collected prior to the injection.|Month 12 and 24|"Population included all enrolled participants treated with Ranibizumab in the extension study or in one of the initial studies. The number of participants for whom data was available at Month 12 and Month 24 are represented by n"||participants|||Number
728321|NCT00379795|Secondary|Change From Baseline in Best Corrected Visual Acuity at a Starting Test Distance of 4 Meters|Change from baseline in Best corrected visual acuity (BCVA) was assessed by the number of letters a patient could read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) Eye Chart at a starting test distance of 4 meters. An increase in the number of letters read indicates improvement in visual acuity.|Extension study baseline, Months 12 and 24|"Enrolled participants. Observed data were used with no imputation. The number of participants for whom data was available for analyses is represented by n."||letters||Standard Deviation|Mean
728322|NCT00379795|Secondary|Change From Baseline in Best Corrected Visual Acuity (BCVA) at a Starting Test Distance of 2 Meters|Change from baseline in Best corrected visual acuity (BCVA) was assessed by the number of letters a patient could read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) Eye Chart at a starting test distance of 2 meters. An increase in the number of letters read indicates improvement in visual acuity.|Extension study baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24|"Enrolled participants. Observed data were used with no imputation. The number of participants for whom data was available for analyses is represented by n."||letters||Standard Deviation|Mean
728323|NCT00379795|Primary|Number of Participants With Non-ocular Adverse Events|"Number of participants with non-ocular adverse events (not occurring in the eye) in the following categories: any adverse events, serious adverse events, adverse events leading to study discontinuation and death.
Only adverse events that occurred during this extension study are reported. For subjects in the crossover groups who started their first ranibizumab injection in this extension study, adverse events that occurred prior to any ranibizumab injection were also excluded.
Additional information about adverse events can be found in the adverse events section."|36 months|Enrolled participants treated with Ranibizumab in this extension study or in one of the previous studies.||participants|||Number
728324|NCT00379795|Primary|Number of Participants With Ocular Adverse Events|"Number of participants with ocular adverse events in the following categories: any adverse events, serious adverse events, adverse events leading to study discontinuation, endophthalmitis and intraocular inflammation that occurred in the study eye (the eye that received all study drug injections) and the fellow eye (other eye).
Only adverse events that occurred during this extension study are reported. For subjects in the crossover groups who started their first ranibizumab injection in this extension study, adverse events that occurred prior to any ranibizumab injection were also excluded."|36 months|All enrolled participants treated with Ranibizumab in this extension study or in one of the previous studies.||participants|||Number
728325|NCT00379808|Other Pre-specified|Epithelial Cell-derived Neutrophil-activating Peptide 78 (ENA-78)|biomarker determined by enzyme-linked immunosorbant assay.|1 month|those completing the entire study||pg/ml||Inter-Quartile Range|Median
728326|NCT00379808|Other Pre-specified|Interleukin 1 Receptor Antagonist (IL1ra)|IL1ra was determined by enzyme-linked immunosorbant assay (ELISA)|1 month|all participants who completed the entire study||pg/ml||Inter-Quartile Range|Median
728327|NCT00379808|Other Pre-specified|Monocyte Chemotactic Protein-1 (MCP-1)|biomarker was measured by enzyme-linked immunosorbant assay (ELISA)|1 month|those who completed the entire study||pg/ml||Inter-Quartile Range|Median
728328|NCT00379808|Other Pre-specified|Triglycerides|measured by a clinical laboratory; Quest Laboratories|1 month|those completing the entire study||mg/dl||Inter-Quartile Range|Median
728329|NCT00379808|Secondary|High Density Lipoprotein (HDL)-Cholesterol|Lipid levels were determined at a clinical laboratory (Quest Diagnostics)|1 month|those completing entire study||mg/dl||Inter-Quartile Range|Median
728330|NCT00379808|Primary|High-sensitivity C-reactive Protein|measured in a CLIA clinical laboratory facility (Quest Diagnostics, Tampa, FL)|1 month|based on patients who completed the entire study||mg/dl||Inter-Quartile Range|Median
728436|NCT00380250|Secondary|Month 3 Constipation Severity Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|Change from baseline for month 3|ITT with LOCF||Scale score||Standard Deviation|Mean
728369|NCT00379834|Primary|Diurnal Intraocular Pressure Control|Change from baseline in mean diurnal IOP (measured every two hours from 8AM to 8PM) averaged across on-treatment study visits (week 1, months 1, 6, 12)|12 months|Selected by level funding available||millimeters of mercury||Standard Deviation|Mean
728370|NCT00379899|Secondary|Percent Change in Ca x P|Percent change from baseline in corrected serum calcium x phosphorus (Ca x P) to weeks 44 through 52|Baseline and Weeks 44 through 52|Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score||Percentage||Standard Error|Mean
728371|NCT00379899|Secondary|Absolute Change in Ca x P|Absolute change from baseline in corrected serum calcium x phosphorus to week 44 through week 52|Baseline and Weeks 44 through 52|Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score||(mg/dL)2||Standard Error|Mean
728372|NCT00379899|Secondary|Percent Change in Phosphorus|Percent change from baseline in serum phosphorus to weeks 44 through 52|Baseline and Weeks 44 through 52|Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score||Percentage||Standard Error|Mean
728373|NCT00379899|Secondary|Absolute Change in Phosphorus|Absolute change from baseline in serum phosphorus to weeks 44 through 52|Baseline and Weeks 44 through 52|Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score||mg/dL||Standard Error|Mean
728374|NCT00379899|Secondary|Percent Change in Calcium|Percent change from baseline in corrected serum calcium to weeks 44 through 52|Baseline and Weeks 44 through 52|Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score||Percentage||Standard Error|Mean
728375|NCT00379899|Secondary|Absolute Change in Calcium|Absolute change from baseline in serum calcium to weeks 44 through 52|Baseline and Weeks 44 through 52|Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score||mg/dL||Standard Error|Mean
728376|NCT00379899|Secondary|Percent Change in PTH|Percent change from baseline in intact Parathyroid Hormone (iPTH)|Baseline and Week 52|Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score||Percentage||Standard Error|Mean
728377|NCT00379899|Secondary|Change From Baseline of the Progression of AVC.|Change from baseline in the aortic valve calcification (AVC) score. AVC score ranges from 0 to >10,000, with 0 representing no calcification.|Baseline and Week 52|Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score||Units on a scale||Standard Error|Mean
728378|NCT00379899|Secondary|Change From Baseline in AC Score|Change from baseline in aortic calcification (AC) score at week 52. AC score ranges from 0 to >75,000, with 0 representing no calcification.|Baseline and Week 52|Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score||Units on a scale||Standard Error|Mean
728379|NCT00379899|Secondary|Absolute Change in PTH|Absolute change from baseline in intact Parathyroid Hormone (iPTH)|Baseline and Week 52|Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score||pg/mL||Standard Error|Mean
728380|NCT00379899|Secondary|Number of Participants Achieving > 15% Progression of CAC.|Number of participants achieving >15% progression of coronary artery calcification (CAC) at week 52|52 weeks|Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score||Participants|||Number
728437|NCT00380250|Secondary|Month 2 Constipation Severity Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|Change from baseline for month 2|ITT with LOCF||Scale score||Standard Deviation|Mean
728381|NCT00379899|Primary|Percent Change From Baseline in CAC Score|Percent Change from baseline to week 52 in coronary artery calcification (CAC) score. CAC score ranges from 0 to 7500, with 0 representing no calcification.|Baseline and Week 52|Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score||Units on a scale||Standard Error|Mean
728382|NCT00379912|Secondary|BclXL Expression||Six months|Analysis of BclXL expression was undertaken irrespective of arm assignment and categorized between responsers and non-responders||percentage L27 mRNA||Standard Error|Mean
728383|NCT00379912|Secondary|Percent Apoptosis in 34+36+71+ Cells at Baseline, Three Cycles and Six Cycles||Six months|Analysis of percent apoptosis was undertaken irrespective of arm assignment and categorized between responsers and non-responders||percentage of cells||Standard Error|Mean
728384|NCT00379912|Secondary|Analysis of CD34, CD71, CD36 Cells in Aspirated Bone Marrow for Both Responders and Non-responders at Baseline and After Three and Six Cycles||6 months|Analysis of CD34, CD71, and CD36 cells was undertaken irrespective of arm assignment.||cells of BM (10e^6/ML)||Standard Error|Mean
728385|NCT00379912|Secondary|Quality of Life|Data for this outcome measure was not collected or analyzed due to the termination of the study|24 months||||||
728386|NCT00379912|Secondary|Duration of Significant Responses|Data for this outcome measure was not collected or analyzed due to the termination of the study.|24 months||||||
728387|NCT00379912|Secondary|Safety Profile of the Modified Dose/Schedule of Azacitidine and Erythropoietin or a Modified Dose of Azacitidine Alone|Full adverse event information is submitted in the record below. A summary of the Significant Toxicities Rate (clinically significant myelosuppression (CTCAE Grade 3 or 4 neutropenia or thrombocytopenia)) over all patients receiving at least 1 dose of study medication at the time of interim analysis is reported in this outcome measure.|24 months|All patients receiving at least 1 dose of study medication at the time of interim analysis.||percentage of participants||90% Confidence Interval|Number
728388|NCT00379912|Primary|Overall Response Rate After Six Cycles|"Overall response rate for participants who have completed at least six cycles of protocol-specified therapy according to the International Working Group to Standardize Response Criteria for Myelodysplastic Syndromes criteria for Erythroid Response (HI-E) Major response: For patients with pretreatment hemoglobin less than 11 g/dL, greater than 2 g/dL increase in hemoglobin; for RBC transfusion-dependent patients, transfusion independence.
Minor response: For patients with pretreatment hemoglobin less than 11 g/dL, 1 to 2 g/dL increase in hemoglobin; for RBC transfusion-dependent patients, 50% decrease in transfusion requirements."|6 months|Participants completing at least six cycles at the time of analysis.||percentage of participants responding||90% Confidence Interval|Number
728389|NCT00379912|Primary|Overall Response After Cycle 3|"Overall response for participants who have completed at least three cycles of protocol-specified therapy according to the International Working Group to Standardize Response Criteria for Myelodysplastic Syndromes criteria for Erythroid Response (HI-E) Major response: For patients with pretreatment hemoglobin less than 11 g/dL, greater than 2 g/dL increase in hemoglobin; for RBC transfusion-dependent patients, transfusion independence.
Minor response: For patients with pretreatment hemoglobin less than 11 g/dL, 1 to 2 g/dL increase in hemoglobin; for RBC transfusion-dependent patients, 50% decrease in transfusion requirements."|3 months|Participants completing at least three cycles at the time of analysis.||percentage of participants responding||90% Confidence Interval|Number
728390|NCT00380029|Secondary|Number of Subjects Experiencing Adverse Events|The incidence of all toxicities observed during neoadjuvant and adjuvant treatment phase.Toxicity will be graded per the Common Terminology Criteria for Adverse Events (CTCAE) 2.0.|4 weeks - 2 years following surgery|All patients enrolled received the full 4-week neoadjuvant course of erlotinib. 12 patients continued on erlotinib in the adjuvant phase for a mean (range) duration of 29 (5-84) weeks.||Participants|||Count of Participants
728391|NCT00380029|Secondary|Overall Survival Rate|The number of patients who remained alive and with no evidence of disease at the mean (range) follow-up of 24.8 months (3.0-36.6).|25 months|||Participants|||Count of Participants
728392|NCT00380029|Secondary|Disease Recurrence and Progression Rates After Cystectomy|To determine disease recurrence/progression rates after cystectomy in patients treated with erlotinib|2 years|||Participants|||Count of Participants
728393|NCT00380029|Secondary|Pathological Complete Response Rate|Determine the pathological complete response rate (P0 rate) after undergoing radical cystectomy (RC). Evaluated using Response Evaluation Criteria In Solid Tumors (RECIST). Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|4 weeks|||Participants|||Count of Participants
728394|NCT00380029|Primary|EGFR Activation Signal (AKT2) Expression to Predict Sensitivity to Erlotinib|Determine the effect of neoadjuvant erlotinib hydrochloride on histopathological, molecular, and genetic correlates in patients undergoing radical cystectomy for muscle-invasive bladder cancer. Gene expression of pre-treatment and post-treatment tumor samples were analyzed to define molecular determinants of response or resistance to epidermal growth factor receptor (EGFR) inhibition. Both in vitro and in vivo EGFR-associated signatures were evaluated on pre-treatment bladder tumors. Candidate molecular determinants of sensitivity to EGFR inhibition were characterized and examined for their ability to predict sensitivity to EGFR inhibitors in vitro.|4 weeks before treatment and 4 weeks post treatment|Only patients with tumor samples with sufficient and high quality RNA were used to generate the in vivo signatures.||fold change||Full Range|Mean
728395|NCT00380068|Secondary|Long-term Survival|Defined as not dying during study participation|Baseline to Week 48|Full Analysis Set. Participants who were lost to follow-up were censored at the date of last contact.||Percentage of participants|||Number
728396|NCT00380068|Secondary|Long-term Survival|Defined as not dying during study participation|Baseline to Week 24|Full Analysis Set. Participants who were lost to follow-up were censored at the date of last contact.||Percentage of participants|||Number
728397|NCT00380068|Secondary|Monotherapy Treatment Status|Defined by no addition of sildenafil, iloprost, treprostinil, or epoprostenol to ongoing ambrisentan treatment|Baseline to Week 48|Full Analysis Set - Subset of participants who were not receiving other PH therapy at baseline.||Percentage of participants|||Number
728398|NCT00380068|Secondary|Monotherapy Treatment Status|Defined by no addition of sildenafil, iloprost, treprostinil, or epoprostenol to ongoing ambrisentan treatment|Baseline to Week 24|Full Analysis Set - Subset of participants who were not receiving other PH therapy at baseline.||Percentage of participants|||Number
728401|NCT00380068|Secondary|Percent of Participants With no Clinical Worsening of PH at Week 48|Clinical worsening: occurrence of death, lung transplantation, hospitalization for PH, atrial septostomy, a change to chronic prostanoid or sildenafil treatment due to protocol-defined worsening criteria, or study withdrawal due to the addition of other clinically approved PH therapeutic agents|Baseline to Week 48|Full analysis set. Participants who were lost to follow-up were censored at the date of last contact.||Percentage of participants|||Number
728402|NCT00380068|Secondary|Percent of Participants With no Clinical Worsening of Pulmonary Hypertension (PH) at Week 24|Clinical worsening: occurrence of death, lung transplantation, hospitalization for PH, atrial septostomy, a change to chronic prostanoid or sildenafil treatment due to protocol-defined worsening criteria, or study withdrawal due to the addition of other clinically approved PH therapeutic agents|Baseline to Week 24|Full analysis set. Participants who were lost to follow-up were censored at the date of last contact.||Percentage of participants|||Number
728403|NCT00380068|Secondary|Change From Baseline to Week 48 in SF-36 Health Survey Physical Functioning Scale|Change from baseline to Week 48 in the SF-36 health survey physical functioning scale. 10 activities are rated by health limitations using 3 categories (1= Yes, limited a lot; 2= Yes, limited a little; and 3= No, not limited at all). The best score is 3 and the worst score is 1. Scores are transformed by subtracting the unit by the lowest raw score and dividing by the raw score range. The scores are then standardized with the 1998 General US population mean and standard deviation. Finally, the scores are transformed to the norm-based scoring with a mean of 50 and standard deviation of 10.|Baseline to Week 48|Full Analysis Set. Last Observation Carried forward. 25 participants were excluded from the analysis due to lack of baseline or post-baseline SF-36 data.||Units on a scale||Standard Deviation|Mean
728404|NCT00380068|Secondary|Change From Baseline to Week 24 in SF-36 Health Survey Physical Functioning Scale|Change from baseline to Week 24 in the SF-36 health survey physical functioning scale. 10 activities rated by health limitations using 3 categories (1= Yes, limited a lot; 2= Yes, limited a little; and 3= No, not limited at all). The best score is 3 and the worst score is 1. Scores are transformed by subtracting the unit by the lowest raw score and dividing by the raw score range. The scores are then standardized with the 1998 General United States (US) population mean and standard deviation (SD). Finally, the scores are transformed to the norm-based scoring with a mean of 50 and SD of 10.|Baseline to Week 24|Full Analysis Set. Last Observation Carried forward. 26 participants were excluded from the analysis due to lack of baseline or post-baseline SF-36 data.||Units on a scale||Standard Deviation|Mean
728405|NCT00380068|Secondary|Change From Baseline to Week 48 in WHO Functional Class|Change from baseline in WHO at Week 48 is expressed as the incidence of participants that improved, had no change or worsened. WHO categories range from 1 to 4 with the worse category at 4. Improvement = a category change from baseline of <= -1: change of -3 (eg, WHO from 4 to 1), change of -2 (eg, WHO from 3 to 1), change of -1 (eg, WHO from 2 to 1). Inversely, participants worsening are those with a category change from baseline of at least +1. No change in WHO functional class represents the percentage of participants with a change in category from baseline of 0.|Baseline to Week 48|Full Analysis Set. Observed Data. 3 participants were not analyzed due to lack of post-baseline WHO functional class data.||Percentage of participants|||Number
728406|NCT00380068|Secondary|Change From Baseline to Week 24 in WHO Functional Class|Change from baseline in World Health Organization functional class (WHO) at Week 24 is the incidence of participants that improved, had no change, or worsened. WHO categories are 1 to 4 with the worse category at 4. Improvement = a category change from baseline of <= -1: change of -3 (eg, WHO from 4 to 1), change of -2 (eg, WHO from 3 to 1), change of -1 (eg, WHO from 2 to 1). Inversely, participants worsening are those with a category change from baseline of at least +1. No change in WHO functional class represents the percentage of participants with a change in category from baseline of 0.|Baseline to Week 24|Full Analysis Set. Last Observation Carried Forward. 3 participants were not analyzed due to lack of post-baseline WHO functional class data.||Percentage of participants|||Number
728407|NCT00380068|Secondary|Percent Change From Baseline to Week 48 in BNP||Baseline to Week 48|Full Analysis Set. Observed data. 111 participants were excluded from the analysis due to lack of baseline or Week 48 BNP data.||Percent change in BNP||95% Confidence Interval|Geometric Mean
728408|NCT00380068|Secondary|Percent Change From Baseline to Week 24 in B-type Natriuretic Peptide (BNP)||Baseline to Week 24|Full Analysis Set. Last Observation Carried forward. 10 participants were excluded from the analysis due to lack of baseline or post-baseline BNP data.||Percent change in BNP||95% Confidence Interval|Geometric Mean
728409|NCT00380068|Secondary|Change From Baseline to Week 48 in Borg Dyspnea Index|Change from Baseline to Week 48 in Borg Dyspnea Index. The Borg Dyspnea Index of Perceived Exertion Scores range from 0 to 10. Best and Worst values are: 0 (Best) to 10 (Worst). Scales are described as rating of breathlessness and its description: 0= none; 0.5= very,very slight (just noticeable); 1= very slight; 2=slight; 3= moderate; 4= somewhat severe; 5= severe; 6 (in between severe and very severe); 7= very severe; 8 (in between very, very severe and maximum); 9= very, very severe; and 10= maximum.|Baseline to Week 48|Full Analysis Set. Observed data. 114 participants were excluded from the analysis due to lack of Week 48 Borg Dyspnea Index data.||Units on a scale||Standard Deviation|Mean
728410|NCT00380068|Secondary|Change From Baseline to Week 24 in Borg Dyspnea Index|Change from Baseline to Week 24 in Borg Dyspnea Index. The Borg Dyspnea Index of Perceived Exertion Scores range from 0 to 10. Best and Worst values are: 0 (Best) to 10 (Worst). Scales are described as rating of breathlessness and its description: 0= none; 0.5= very,very slight (just noticeable); 1= very slight; 2=slight; 3= moderate; 4= somewhat severe; 5= severe; 6 (in between severe and very severe); 7= very severe; 8 (in between very, very severe and maximum); 9= very, very severe; and 10= maximum.|Baseline to Week 24|Full Analysis Set. Last Observation Carried forward. 4 participants were excluded from the analysis due to lack of post-baseline Borg Dyspnea Index data.||Units on a scale||Standard Deviation|Mean
728411|NCT00380068|Primary|Change From Baseline to Week 24 in 6 Minute Walk Distance (6MWD)||Baseline to Week 24|Full Analysis Set. Last Observation Carried forward. 4 participants were excluded from the analysis due to lack of post-baseline 6MWD data.||meters||Standard Deviation|Mean
728412|NCT00380081|Post-Hoc|Subjective Number of Awakenings After Middle-of-the-Night Awakening|Number of times a participant awoke following sleep onset after the middle-of-the-night awakening, as documented by the participant for each day of every two-day treatment period using the Treatment Morning Sleep Questionnaire.|Days 1 and 2 for each treatment|Intent to treat population||number of awakenings||95% Confidence Interval|Least Squares Mean
728413|NCT00380081|Secondary|Polysomnography Number of Awakenings After Middle-of-the-Night Awakening|Number of times a participant awoke following sleep onset after the middle-of-the-night awakening, as measured by polysomnography for each day of every two-day treatment period.|Days 1 and 2 for each treatment|Intent to treat population||number of awakenings||95% Confidence Interval|Least Squares Mean
728414|NCT00380081|Secondary|Subjective Wake Time After Sleep Onset After Middle-of-the-Night Awakening|Amount of time awake after sleep onset following a middle-of-the-night awakening was recorded by participants using the Treatment Morning Sleep Questionnaire for each day of every two-day treatment period.|Days 1 and 2 for each treatment|Intent to treat population||minutes||95% Confidence Interval|Least Squares Mean
728415|NCT00380081|Secondary|Polysomnography Wake Time After Sleep Onset Following Middle-of-the-Night Awakening|Amount of time awake after sleep onset following a middle-of-the-night awakening was measured by polysomnography for each day of every two-day treatment period.|Days 1 and 2 for each treatment|Intent to treat population||minutes||95% Confidence Interval|Least Squares Mean
728416|NCT00380081|Secondary|Subjective Sleep Onset Latency After Middle-of-the-Night Awakening|Participants documented the time to return to sleep after a middle-of-the-night (MOTN) awakening for each day of every two-day treatment period using the Treatment Morning Sleep Questionnaire.|Days 1 and 2 for each treatment|Intent to treat population||minutes||95% Confidence Interval|Least Squares Mean
728417|NCT00380081|Secondary|Polysomnography Sleep Efficiency After Scheduled Middle-of-the-Night Awakening|Sleep efficiency is a measurement of the percentage of time asleep to the total time in bed. It was measured by polysomnography for each day of every two-day treatment period.|Days 1 and 2 for each treatment|Intent to treat population||percentage of time asleep||95% Confidence Interval|Least Squares Mean
728418|NCT00380081|Secondary|Subjective Ability to Function|Ability to function was rated by participants for each day of every two-day treatment period using the Treatment Morning Sleep Questionnaire. The percentage of participants within each rating category is reported. The rating scale was poor, fair, good and excellent.|Days 1 and 2 for each treatment|Intent to treat population||percentage of participants|||Number
728419|NCT00380081|Secondary|Subjective Level of Refreshed Sleep|Level of refreshed sleep was rated by participants for each day of every two-day treatment period using the Treatment Morning Sleep Questionnaire. The percentage of participants within each rating category is reported. The rating scale was poor, fair, good and excellent.|Days 1 and 2 for each treatment|Intent to treat population||percentage of participants|||Number
728420|NCT00380081|Secondary|Subjective Sleep Quality Rating|Sleep quality was rated by participants for each day of every two-day treatment period using the Treatment Morning Sleep Questionnaire. The percentage of participants within each rating category is reported. The rating scale was poor, fair, good and excellent.|Days 1 and 2 for each treatment|Intent to treat population||percentage of participants|||Number
728421|NCT00380081|Other Pre-specified|Latency to Persistent Sleep After Middle-of-the-Night Awakening as Measured by Polysomnography for a Subpopulation of Participants With More Severe Insomnia|Polysomnography was used to measure the time to return to persistent sleep after a middle-of-the-night (MOTN) awakening for each day of every two-day treatment period in a subpopulation of patients with greater than 60 minutes to fall asleep after a MOTN awakening at baseline.|Days 1 and 2 for each treatment|Intent to treat population||minutes||95% Confidence Interval|Least Squares Mean
728422|NCT00380081|Secondary|Average Subjective Total Sleep Time After Scheduled Middle-of-the-Night Awakening|The time from return to persistent sleep after a middle-of-the-night (MOTN) awakening until final awakening for each day of every two-day treatment period was recorded by each participant using the Treatment Morning Sleep Questionnaire.|Days 1 and 2 for each treatment|Intent to treat population||minutes||95% Confidence Interval|Least Squares Mean
728423|NCT00380081|Other Pre-specified|Total Sleep Time After Scheduled Middle-of-the-Night Awakening Measured by Polysomnography for Participants With More Severe Insomnia|Polysomnography was used to measure the time from return to persistent sleep after a middle-of-the-night (MOTN) awakening until final awakening for each day of every two-day treatment period in the subpopulation of patients with greater than 60 minutes to fall asleep after a MOTN awakening at baseline.|Days 1 and 2 for each treatment|Intent to treat population||minutes||95% Confidence Interval|Least Squares Mean
728424|NCT00380081|Secondary|Total Sleep Time After Scheduled Middle-of-the-Night Awakening Measured by Polysomnography|Polysomnography was used to measure the time from return to persistent sleep after a middle-of-the-night (MOTN) awakening until final awakening for each day of every two-day treatment period.|Days 1 and 2 for each treatment|Intent-to-treat population.||minutes||95% Confidence Interval|Least Squares Mean
728425|NCT00380081|Secondary|Number of Treatment Responders Based on Polysomnography Latency to Persistent Sleep After Middle-of-the-Night Awakening|Polysomnography was used to measure the time to return to persistent sleep after a middle-of-the-night (MOTN) awakening for each day of every two-day treatment period. A participant was considered to be a responder if the time to return to persistent sleep was less than twenty minutes.|Days 1 and 2 for each treatment|Intent to treat population||participants|||Number
728426|NCT00380081|Primary|Latency to Persistent Sleep After Middle-of-the-Night Awakening as Measured by Polysomnography|Polysomnography was used to measure the time to return to persistent sleep after a middle-of-the-night (MOTN) awakening for each day of every two-day treatment period.|Days 1 and 2 for each treatment|Intent-to-treat population||minutes||95% Confidence Interval|Least Squares Mean
728427|NCT00380250|Secondary|Month 3 Abdominal Pain Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|Change from baseline for month 3|||Scale Score||Standard Deviation|Mean
728428|NCT00380250|Secondary|Month 2 Abdominal Pain Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|Change from baseline for month 2|||Scale Score||Standard Deviation|Mean
728429|NCT00380250|Secondary|Month 1 Abdominal Pain Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|Change from baseline for month 1|||Scale Score||Standard Deviation|Mean
728430|NCT00380250|Secondary|Month 3 Bowel Movement Frequency Rates Change From Baseline||Change from baseline for month 3|ITT, with LOCF||BM/week||Standard Deviation|Mean
728431|NCT00380250|Secondary|Month 2 Bowel Movement Frequency Rates Change From Baseline||Change from baseline for month 2|ITT, with LOCF||BM/week||Standard Deviation|Mean
728432|NCT00380250|Secondary|Month 1 Bowel Movement Frequency Rates Change From Baseline||Change from baseline for month 1|ITT, with LOCF||BM/week||Standard Deviation|Mean
728446|NCT00380250|Secondary|Month 1 Responder Rate|"Symptoms >= Moderately relieved for 4 weeks/month or Significantly relieved for >=2 weeks/month AND:
Rescue medication use does not increase during the month as compared to baseline;
No discontinuation during the month due to lack of efficacy;AND
No ratings during the month of Moderately worse or Significantly worse."|month 1 (28 days)|ITT without LOCF||percent of participants|||Number
728447|NCT00380250|Secondary|Month 3 Responder Rate|"Symptoms >= Moderately relieved for 4 weeks/month or Significantly relieved for >=2 weeks/month AND:
Rescue medication use does not increase during the month as compared to baseline;
No discontinuation during the month due to lack of efficacy;AND
No ratings during the month of Moderately worse or Significantly worse."|month 3 (28 days)|ITT without LOCF||percent of participants|||Number
728448|NCT00380250|Secondary|Month 2 Responder Rate|"Monthly responder: >=Moderately relieved symptoms 4 weeks/month or Significantly relieved >= 2 weeks/month IF:
Rescue med use did not increase during the month; AND did not discontinue during the month for lack of efficacy; AND no Moderately worse or Significantly worse response in month."|month 2 (28 days)|ITT without LOCF||percent of participants|||Number
728449|NCT00380250|Primary|Overall Responder Rate|"Monthly responder: >=Moderately relieved symptoms 4 weeks/month or Significantly relieved >= 2 weeks/month IF:
Rescue med use did not increase during the month; AND did not discontinue during the month for lack of efficacy; AND no Moderately worse or Significantly worse response in month.
Overall responder: responder for at least 2/3 months"|12 weeks|Intent-to-treat (ITT) without Last Observation Carried Forward (LOCF)||percentage of participants|||Number
728450|NCT00380250|Secondary|Quality of Life Change From Baseline|Irritable Bowel Syndrome Quality of Life (IBS-QOL) questionnaire included 34 questions with 5 possible responses yielding the following sub-categories: dysphoria, interference with activity, body image, health worry, food avoidance, social reaction, sexual, and relationship Results range from 34 (low) to 100 (high); meaningful clinical improvement=14 point increase|Change from baseline at 12 weeks|ITT without LOCF||Scale score||Standard Deviation|Mean
728451|NCT00380250|Secondary|Month 1 Symptom Relief|Significantly worse = -3; Moderately worse = -2; A little bit worse = -1; Unchanged = 0; A little bit relieved=1; Moderately relieved=2; Significantly relieved = 3|Change from baseline for month 1|ITT with LOCF||Scale score||Standard Deviation|Mean
728452|NCT00380250|Secondary|Month 1 Constipation Severity Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|Change from baseline at 28 days|ITT with LOCF||Scale score||Standard Deviation|Mean
728453|NCT00380250|Secondary|Month 1 Bowel Straining Change From Baseline|0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|Change from baseline for month 1|ITT with LOCF||Scale score||Standard Deviation|Mean
728454|NCT00380250|Secondary|Month 1 Stool Consistency Change From Baseline|0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)|Change from baseline for month 1|ITT with LOCF||Scale score||Standard Deviation|Mean
728455|NCT00380250|Secondary|Month 1 Spontaneous Bowel Movement (SBM) Frequency Rates Change From Baseline|SBMs are any bowel movement not associated with rescue medication use.|Change from baseline for month 1|ITT with LOCF||SBM/week||Standard Deviation|Mean
728456|NCT00380367|Primary|Number of Participants With Any Adverse Events (AEs), Injection-site AEs, Systemic AEs, or Vaccine-related AEs During the Study|"An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR’s product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the SPONSOR’s product, was also an AE. Pre-specified injection site AEs included pain, tenderness, erythema, and swelling. A vaccine-related AE was an AE considered by the investigator to be possibly, probably, or definitely related to the vaccine. All AEs collected on participant’s Vaccination Report Card daily for 14 days after each vaccination (Days 1-15).
The number of participants who experienced ≥1 AE, the number of participants who experienced ≥1 injection site AE, the number of participants who experienced ≥1 systemic AE, and the number of participants who experienced ≥1 vaccine-related AE were reported for the Safety Cohort."|Up to 7 months|Safety Cohort: All enrolled participants who received ≥1 injection and had safety follow-up data. Two participants did not have safety follow-up data and were excluded from safety analyses.||participants|||Number
728457|NCT00380367|Primary|Percentage of Participants Who Seroconvert to Each HPV Serotype (Types 6, 11, 16, 18) at Month 7|Month 7 HPV competitive Luminex Immunoassay (cLIA) seroconversion rates among participants who received Quadrivalent HPV (Types 6, 11, 16, 18) Late 1 (L1) capsid protein VLP vaccine were reported. The quadrivalent HPV competitive cLIA (v2.0) was used to detect antibody to HPV VLPs serotypes 6, 11, 16, 18 before and after vaccination with the HPV quadrivalent vaccine. Seropositivity cutoffs of the HPV cLIAs were assessed using a panel of sera from participants highly likely to be HPV naïve (children), and from participants who were highly likely to be seropositive. Any sample with a value less than the cutoffs was considered serostatus negative. Samples with values equal to or greater than the cutoff were considered serostatus positive. The cutoffs for the HPV 6, 11, 16, and 18 cLIAs were 20 milli‐Merck units per milli liter (mMU/mL), 16 mMU/mL, 20 mMU/mL, and 24 mMU/mL, respectively.|One month post-dose 3 (Month 7)|Per‐Protocol (P-P) immunogenicity population: All participants who were not general protocol violators, received all 3 vaccinations within acceptable day ranges, were sero-negative at Day 1 for the relevant HPV type(s), and had a Month 7 serum sample collected within an acceptable day range.||percentage of participants||95% Confidence Interval|Number
728458|NCT00366301|Primary|Percentage Reduction in C-reactive Protein (CRP)||14 weeks|As hsCRP was measured at both 6 and 14 weeks, linear mixed models conditioning on baseline hsCRP and adjusting for treatment stratum were constructed with the dependent variable being change in lnCRP. Any subject having either or both 6 week and 14 week measures was included.||Percent CRP Reduction||95% Confidence Interval|Mean
728459|NCT00366340|Primary|Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series)|Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may be represented in more than 1 category.|Day 1 through 4 after each dose|Safety population, participants who received given dose; (n)= number of participants reporting yes for at least 1 day or no for all days.||percentage of participants|||Number
728513|NCT00367380|Primary|Infection for P. Vivax|Thick blood smear was performed to patients daily on days 7 to 23, and every other day until day 29. Any prove of P. vivax infection was considered positive and confirmed later by real time polymerase chain reaction (rPCR).|Twenty eight days|||days||Standard Deviation|Mean
728460|NCT00366340|Primary|Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series)|Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may be represented in more than 1 category.|Day 1 through 4 after each dose|Safety population, participants who received given dose; (n)= number of participants reporting yes for at least 1 day or no for all days.||percentage of participants|||Number
728461|NCT00366340|Primary|Percentage of Participants Reporting Pre-Specified Local Reactions|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (Sig) (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (Mod)(2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Day 1 through 4 after each dose|Safety population, included participants who received given dose; (n) = number of participants reporting the specific characteristic.||percentage of participants|||Number
728462|NCT00366340|Primary|Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose|Antibody concentration/geometric mean concentration as measured by ELISA with their corresponding 95% CI immediately before and after the toddler dose for 7 common pneumococcal serotypes (Serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|Immediately before (12 months of age) and one month after the toddler dose (13 months of age)|Evaluable immunogenicity (per protocol) population of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n)= number of participants with a determinate antibody concentration for the specified concomitant antigen.||μg/mL||95% Confidence Interval|Geometric Mean
728463|NCT00366340|Primary|Geometric Mean Antibody Concentration of Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose|Antibody geometric mean concentration (GMC) as measured by mcg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age)|Evaluable immunogenicity (per protocol) population of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N)= number of participants with a determinate antibody concentration for the specified concomitant antigen.||mIU/mL||95% Confidence Interval|Geometric Mean
728464|NCT00366340|Primary|Geometric Mean Antibody Concentration of Diphtheria Toxoid in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose||One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age)|Evaluable immunogenicity (per protocol) population of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N)= number of participants with a determinate antibody concentration for the specified concomitant antigen.||IU/mL||95% Confidence Interval|Geometric Mean
728465|NCT00366340|Primary|Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose||One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age)|Evaluable immunogenicity (per protocol) population of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N)= number of participants with a determinate antibody concentration for the specified concomitant antigen.||μg/mL||95% Confidence Interval|Geometric Mean
728466|NCT00366340|Primary|Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose|Predefined Antibody Levels for Haemophilus Influenzae Type b (0.15 µg/mL or 1.0 µg/mL), for Diphtheria Toxoid (0.01 or 0.1 International units [IU]/mL) and for Hepatitis B (≥ 10.0 mIU/mL).|One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age)|Evaluable immunogenicity (per protocol) population of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N)= number of participants with a antibody concentration ≥ the prespecified level for the given concomitant antigen.||Percentage of Participants||95% Confidence Interval|Number
728467|NCT00366340|Primary|Geometric Mean Antibody Titer in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series|Antibody functionality/geometric mean titer (GMT) as measured by opsonophagocytic activity assay (OPA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after 3-dose infant series (5 months of age)|Evaluable immunogenicity (per protocol) population of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n)= number of participants with a determinate antibody titer for the specified serotype.||titer||95% Confidence Interval|Geometric Mean
728468|NCT00366340|Primary|Percentage of Participants Achieving Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series.|Percentage of Participants achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after 3-dose infant series (5 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n)=number of participants with a determinate postinfant series OPA antibody titer to the given serotype.||Percentage of Participants||95% Confidence Interval|Number
728510|NCT00367237|Primary|Number of Subjects Achieving ACR20 (at Least 20% Improvement in American College of Rheumatology Criteria From Baseline) at Week 16|>=20% improvement in swollen and tender joint count AND >=20% improvement in 3 of the following: visual analog scale (VAS) assessment of pain; subject VAS global assessment of disease activity; evaluator VAS global assessment of disease activity; Health Assessment Questionnaire (HAQ) disability index; C-Reactive Protein (CRP) level.|between baseline and week 16|Number of subjects from Intent-to-Treat population in each arm at Week 16||participants|||Number
728469|NCT00366340|Primary|Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series|Antibody concentration/geometric mean concentration (GMC) as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC ratios (13vPnC/7vPnC) and corresponding 2-sided 95% CI were evaluated.|One month after 3-dose infant series (5 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations.||μg/mL||95% Confidence Interval|Geometric Mean
728470|NCT00366340|Primary|Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series|Percentage of Participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35 μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after 3-dose infant series (5 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations.||Percentage of Participants||95% Confidence Interval|Number
728471|NCT00366444|Secondary|Number of Patients Who Required Rescue Medication on Day 3|Day 3 data reflect the use of rescue medication only up to the time of discharge|Day 3|||participants|||Number
728472|NCT00366444|Secondary|Number of Patients Who Required Rescue Medication on Day 2||Day 2|||participants|||Number
728473|NCT00366444|Secondary|Number of Patients Who Required Rescue Medication on Day 1||Day 1|||participants|||Number
728474|NCT00366444|Secondary|Time to Onset of at Least 30% Reduction in Pain Intensity After First Dose of Study Drug||8 hours post single dose|"Number of participants analyzed includes only the number of participants with at least a 30% reduction in pain intensity after the 1st dose (see previous outcome measure, #7).
Number of placebo patients is intentionally blank as the data (eg., upper CI) was not calculable."||minutes||95% Confidence Interval|Median
728475|NCT00366444|Secondary|Number of Patients With at Least 30% Reduction in Pain Intensity After First Dose of Study Drug||8 hours post single dose|||participants|||Number
728476|NCT00366444|Secondary|Total Pain Relief (TOTPAR) Scores 8 Hours Post Initial Dose of Study Drug|Pain relief was rated using a 5-point categorial scale (0=none, 1=a little, 2=some, 3=a lot, and 4=complete) at time of dose (time=0) and over 15 time points afterwards (10, 15, 20, 30, 45, and 60 minutes and at 1.5, 2, 2.5, 3, 4, 5, 6, 7, and 8 hours after the initial dose on Day 1 or until time of re-medication). A score of 0 across all time points would be the lowest (worst) and a score of 60 (4 X 15 time points) would be the highest (best) possible score.|8 hours post single dose|||units on a scale||Standard Deviation|Mean
728477|NCT00366444|Secondary|Median Time to Onset of Pain Relief in Patients With Meaningful Pain Relief on Day 1||8 hours post single dose|"Number of participants analyzed includes only the number of participants with meaningful pain relief on Day 1 (see previous outcome measure, #4).
Number of patients in the placebo group is intentionally blank as the data was not calculable since less than 50% of the patients reported meaningful relief (ie, median cannot be calculated)."||minutes||95% Confidence Interval|Median
728478|NCT00366444|Secondary|Number of Patients With Meaningful Pain Relief on Day 1|Times to onset of Perceptible and Meaningful Relief were determined using the double-stopwatch method.|8 hours post single dose|||participants|||Number
728479|NCT00366444|Secondary|Median Time to Onset of Pain Relief in Patients With Perceptible Pain Relief on Day 1||8 hours post single dose|Number of participants analyzed includes only the number of participants with perceptible pain relief on Day 1 (see previous Outcome Measure #2)||minutes||95% Confidence Interval|Median
728480|NCT00366444|Secondary|Number of Patients With Perceptible Pain Relief on Day 1|Times to onset of Perceptible and Meaningful Relief were determined using the double-stopwatch method.|8 hours post single dose|||participants|||Number
728481|NCT00366444|Primary|Average Numeric Pain Rating Score (NPRS) Over 48 Hours After Bunionectomy|Pain intensity scores were measured using an 11-point numerical pain rating scale (NPRS) with 0=no pain to 10=worst possible pain|Over 48 hours after bunionectomy|||units on a scale||Standard Deviation|Mean
728482|NCT00366457|Secondary|Overall Survival|overall survival (OS) = time from study entry until death from any cause|5 years|participants who started treatment||months||95% Confidence Interval|Median
728483|NCT00366457|Secondary|Toxicity Profile|Grade 3-4 treatment-related toxicities (treatment-related = possible, probable, or definite) Grading system: 1= mild, 2 = moderate, 3 = severe, 4 = life-threatening|during and after first 28-day cycle of treatment|participants who started treatment||Participants|||Count of Participants
728484|NCT00366457|Secondary|Response Rate|Response rate using RECIST criteria and latest time point available. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|after at least one 28-day cycle of treatment|participants with response data available||Participants|||Count of Participants
728485|NCT00366457|Primary|Time to Tumor Progression|"Time to tumor progression (TTP) = time from date of initial treatment to first objective documentation of progressive disease or death; patients who die without a reported prior progression will be considered to have progressed on the day of their death.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions."|all patients will be followed for a minimum of 4 months|participants who started treatment||months||95% Confidence Interval|Median
728486|NCT00366548|Secondary|Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose|GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|one month after the toddler dose (at 13 months of age)|Evaluable immunogenicity population had valid and determinate assay results, and had no other major protocol violations, (n) = number of participants with a determinate IgG antibody concentration for the specified serotype.||μg/mL||95% Confidence Interval|Geometric Mean
728487|NCT00366548|Primary|Geometric Mean Antibody Concentration (GMC) in 13vPnC+P80 Group Relative to 13vPnC-P80 Group After the 3-Dose Infant Series|GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after 3-dose infant series (at 5 months of age)|Evaluable immunogenicity population had valid and determinate assay results, and had no other major protocol violations, (n) = number of participants with a determinate antibody concentration for the specified serotype.||μg/mL||95% Confidence Interval|Geometric Mean
728488|NCT00366548|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events|Systemic events (fever [Fv] ≥ 37.5 degrees Celsius [C], fever ≥ 38 C but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased (decr)appetite, irritability, increased (incr)sleep, decreased sleep, hives, use of medication (meds) to treat symptoms (sx), and use of medication to prevent symptoms) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4-days after each dose|The safety population included all subjects who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.||Percentage of Participants|||Number
728489|NCT00366548|Other Pre-specified|Percent of Participants Reporting Pre-Specified Local Reactions|Local reactions were collected using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (Sig) (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (Mod) (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.|Within 4-days after each dose|The safety population included all participants who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.||Percentage of Participants|||Number
728490|NCT00366548|Secondary|Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose|Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥ 0.35 μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|one month after the toddler dose (at 13 months of age)|Evaluable immunogenicity population had valid and determinate assay results, and had no other major protocol violations, (n) = number of participants with a determinate IgG antibody concentration to the given serotype.||percentage of participants||95% Confidence Interval|Number
728491|NCT00366548|Primary|Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC+P80 Group Relative to 13vPnC-80 Group After the Infant Series|Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after 3-dose infant series (at 5 months of age)|Evaluable immunogenicity population had valid and determinate assay results, and had no other major protocol violations, (n) = number of participants with a determinate immunoglobulin G (IgG) antibody concentration to the given serotype.||percentage of participants||95% Confidence Interval|Number
728492|NCT00366626|Primary|Limited Access Alcohol Consumption Paradigm; Total Number of Drinks Consumed|Subjects were allowed to drink up to 8 alcohol drinks during 2 hours observation period being in bar/laboratory settings vs to get $2 per each not consumed drink.|On day 7 of treatment during limited access alcohol consuption in the bar/laboratory|All subjects who were randomized.||Total number of drinks consumed||Standard Deviation|Mean
728493|NCT00366626|Primary|"Natural Alcohol Consumption Period; Average Number of Drinks Per Day Consumed During the 5 Day Natural (Usual Environment) Drinking Observation Period"||treatment days 1 - 5|All subjects who were randomized.||Drinks per day||Standard Deviation|Mean
728494|NCT00366678|Primary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the 3-Dose Infant Series of 13vPnC|Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated.|One month after the 3-Dose Infant Series (at 5 months of age)|The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate antibody concentration for the specified serotype.||μg/mL||95% Confidence Interval|Geometric Mean
728495|NCT00366678|Primary|Percentage of Participants Reporting Pre-Specified Systemic Events|Systemic events (fever [fv] ≥ 37.5 degrees Celsius [C], fever ≥ 38 C but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased [decr] appetite, irritability, increased [incr] sleep, decreased sleep, hives, use of medication [med] to treat symptoms [sx], and use of medication to prevent symptoms) were reported using an electronic diary. Participants may be represented in more than 1 category.|During the 4-day period after each dose|The safety population included all subjects who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.||Percentage of Participants|||Number
728496|NCT00366678|Primary|Percentage of Participants Reporting Pre-Specified Local Reactions|Local reactions were collected using an electronic diary. Tenderness (Tender)was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (Sev) (>7.0 cm). Participants may be represented in more than 1 category.|During the 4-day period after each dose|The safety population included all participants who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.||Percentage of Participants|||Number
728511|NCT00367341|Secondary|Response Defined as 50% Change in Hamilton Depression Rating Scale-17 Score at 12 Weeks|Number of participants with a 50% change from Baseline on the Hamilton Depression Rating Scale-17-item score|Measured at week 12.|completers||participants|||Number
728512|NCT00367341|Primary|Remission Defined as Hamilton Depression Rating Scale-17 Score of Less Than or Equal to 7 at 12 Weeks|# of study participants with Hamilton Depression-17-item score less than or equal to 7.|Measured at week 12|completed study participants in 12-week-trial||participants|||Number
728497|NCT00366678|Primary|Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the 3-Dose Infant Series of 13vPnC|Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after the 3-Dose Infant Series (at 5 months of age)|Evaluable immunogenicity (per protocol) population adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate immunoglobulin G (IgG) antibody concentration to the given serotype.||percentage of participants||95% Confidence Interval|Geometric Mean
728498|NCT00366678|Primary|Geometric Mean Concentration (GMC) as Measured by ELISA for Pertussis Toxin (PT) and Pertussis Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group||One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)|Evaluable immunogenicity (per protocol) population adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.||EU/mL||95% Confidence Interval|Number
728499|NCT00366678|Primary|Geometric Mean Concentration (GMC) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) for Poliomyelitis (Type 1, Type 2 and Type 3) in 13vPnC Group Relative to 7vPnC Group||One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)|Evaluable immunogenicity (per protocol) population adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.||titer||95% Confidence Interval|Number
728500|NCT00366678|Primary|Geometric Mean Concentration (GMC) for Haemophilus Influenzae Type b (Hib) in 13vPnC Group Relative to 7vPnC Group||One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)|Evaluable immunogenicity (per protocol) population adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.||μg/mL||95% Confidence Interval|Number
728501|NCT00366678|Primary|Geometric Mean Concentration (GMC) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) for Diphtheria Toxoid and Tetanus Toxoid in 13vPnC Group Relative to 7vPnC Group||One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)|The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.||IU/mL||95% Confidence Interval|Geometric Mean
728502|NCT00366678|Secondary|Geometric Mean Titer (GMT) in 13vPnC/13vPnC and 7vPnC/13vPnC Groups After the Toddler Dose|GMT as measured by opsonophagocytic activity assay (OPA) for 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after the toddler dose (at 13 months of age)|The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.||titer||95% Confidence Interval|Geometric Mean
728503|NCT00366678|Secondary|Percentage of Participants Achieving Antibody Titer ≥1:8 After the Toddler Dose in 13vPnC/13vPnC and 7vPnC/13vPnC Groups|Percentage of participants achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) along with the corresponding 95% CI for the 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after the toddler dose (at 13 months of age)|The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.||Percentage of Participants||95% Confidence Interval|Number
728504|NCT00366678|Secondary|Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups|Antibody GMC as measured by ELISA for 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after the Toddler Dose (at 13 months of age)|The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.||μg/mL||95% Confidence Interval|Geometric Mean
728505|NCT00366678|Secondary|Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups|Percentages of participants achieving World health Organization (WHO) predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after the toddler dose (at 13 months of age)|Evaluable immunogenicity (per protocol) population who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate antibody concentration for the specified serotype.||percentage of participants||95% Confidence Interval|Number
728506|NCT00366678|Primary|Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group|Percentage of participants achieving predefined antibody threshold levels ≥0.1 IU/mL for diphtheria, ≥0.1 IU/mL for tetanus, ≥ 0.15 μg/mL for Hib polyribosylribitol phosphate (PRP), antibody titer ≥1:8 for polio and ≥5 EU/mL for pertussis (PT and FHA) with the corresponding 95% CI for each concomitant antigen are presented.|One Month After the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)|The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.||percentage of participants||95% Confidence Interval|Number
728507|NCT00367237|Secondary|Adverse Events|This is not a prespecified key secondary outcome; therefore, results will not be disclosed.|between baseline and week 16||||||
728508|NCT00367237|Secondary|Change in Disease Activity Score, Each of the ACR20 Domains, Dactylitis, Enthesitis, Fatigue and Duration of Morning Stiffness, Erythrocyte Sedimentation Rate, and Disability Index of the Health Assessment Questionnaire (HAQ)|This is not a prespecified key secondary outcome; therefore, results will not be disclosed.|between baseline and week 16||||||
728514|NCT00367432|Secondary|Change From Baseline in N01221 [NCT00280696] in Other Types of Seizure Frequency Per Week During the First 16-week Period in This Study|"Change in other types of seizure frequency is given as a percent reduction computed as (other types of seizure frequency:= B):
[ Weekly B (Baseline)- Weekly B (Evaluation Period)]/ [Weekly B (Baseline)] x 100.
Positive values in percent reduction means that the value has decreased from Baseline during the first 16-week Period.
Other types of Seizures are all seizures except Partial Seizures (Type 1)."|Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study|Subset of the FAS population excluding subjects with seizure counts equal to zero during Baseline and Evaluation Period for Other Types of Seizures.||Percent Reduction||Inter-Quartile Range|Median
728515|NCT00367432|Secondary|Change From Baseline in N01221 [NCT00280696] in Simple and Complex Partial Seizure Frequency Per Week During the First 16-week Period in This Study|"Change in simple and complex partial seizure frequency is given as a percent reduction computed as (simple and complex partial seizure frequency := A):
[ Weekly A (Baseline)- Weekly A (Evaluation Period)]/ [Weekly A (Baseline)] x 100.
Positive values in percent reduction means that the value has decreased from Baseline during the first 16-week Period.
Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures."|Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study|Subset of the FAS population excluding subjects with seizure counts equal to zero during Baseline and Evaluation Period for Simple and Complex Partial Seizures.||Percent Reduction||Inter-Quartile Range|Median
728516|NCT00367432|Secondary|Change From Baseline in N01221 [NCT00280696] in Secondary Generalized Seizure Frequency Per Week During the First 16-week Period in This Study|"Change in secondary generalized seizure frequency is given as a percent reduction computed as:
[ Weekly sec. generalized seizure frequency (Baseline)- Weekly sec. generalized seizure frequency (Evaluation Period)]/ [Weekly sec. generalized seizure frequency (Baseline)] x 100.
Positive values in reduction means the value decreased from Baseline during the first 16-week Period.
Secondary generalized seizures belong to one of the 3 groups:
Simple partial sz evolving to gen sz
Complex partial sz evolving to gen sz
Simple partial sz evolving to Complex partial sz evolving to gen sz"|Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study|Subset of the FAS population excluding subjects with seizure counts equal to zero during Baseline and Evaluation Period for Secondary Generalized Seizures.||Percent Reduction||Inter-Quartile Range|Median
728517|NCT00367432|Secondary|Change From Baseline in N01221 [NCT00280696] in Complex Partial Seizure Frequency Per Week During the First 16-week Period in This Study|"Change in complex partial seizure frequency is given as a percent reduction computed as:
[ Weekly complex partial seizure frequency (Baseline)- Weekly complex partial seizure frequency (Evaluation Period)]/ [Weekly complex partial seizure frequency (Baseline)] x 100.
Positive values in percent reduction means that the value has decreased from Baseline during the first 16-week Period.
Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures."|Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study|Subset of the FAS population excluding subjects with seizure counts equal to zero during Baseline and Evaluation Period for Complex Partial Seizures.||Percent Reduction||Inter-Quartile Range|Median
728518|NCT00367432|Secondary|Change From Baseline in N01221 [NCT00280696] in Simple Partial Seizure Frequency Per Week During the First 16-week Period in This Study|"Change in simple partial seizure frequency is given as a percent reduction computed as:
[ Weekly simple partial seizure frequency (Baseline)- Weekly simple partial seizure frequency (Evaluation Period)]/ [Weekly simple partial seizure frequency (Baseline)] x 100.
Positive values in percent reduction means that the value has decreased from Baseline during the first 16-week Period.
Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures."|Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study|Subset of the FAS population excluding subjects with seizure counts equal to zero during Baseline and Evaluation Period for Simple Partial Seizures.||Percent Reduction||Inter-Quartile Range|Median
728519|NCT00367432|Secondary|Response Status (Patients With a Percent Reduction in Partial Seizure Frequency of at Least 50% During the First 16-week Period in This Study From Baseline in N01221)|"The percent reduction from Baseline was computed as:
[ Weekly seizure frequency (Baseline)- Weekly seizure frequency (Evaluation Period)]/ [Weekly seizure frequency (Baseline)] x 100.
Responders are those patients with a percent reduction in partial seizure frequency of at least 50% from Baseline to first Evaluation Period in partial seizure frequency per week.
Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures."|Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study|Full Analysis Set (FAS).||Participants|||Number
728520|NCT00367432|Secondary|Seizure Frequency Per Week in Partial Seizures During the First 16-week Period in This Study|Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures.|First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 ( Week 16)|Full Analysis Set (FAS).||Seizures Per Week||Inter-Quartile Range|Median
728521|NCT00367432|Secondary|Change From Baseline in N01221 [NCT00280696] in Partial (Type 1) Seizure Frequency Per Week During the First 16-week Period in This Study|"The change in partial (type 1) seizure frequency from Baseline is given as a percent reduction computed as:
[ Weekly partial seizure frequency (Baseline)- Weekly partial seizure frequency (Evaluation Period)]/ [Weekly partial seizure frequency (Baseline)] x 100.
Positive values in percent reduction means that the value has decreased from Baseline during the first 16-week Period.
Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures."|Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study|Full Analysis Set (FAS).||Percent Reduction||Inter-Quartile Range|Median
728549|NCT00367835|Secondary|Change From Baseline in Pulse Rate at Up to 8 Weeks||Baseline and up to 8 weeks|Safety population||beats/min||Standard Deviation|Mean
728522|NCT00367432|Primary|Occurrence of Treatment-emergent Adverse Events During the Study Period (Until the Time of Approval Granted)|"An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with the pharmaceutical product.
Occurrence of treatment-emergent AEs is reported by the number of subjects with at least one treatment-emergent AE."|During the study period from Visit 1 (Week 0) to the Follow-up Visit (up to Month 60) until the time of approval granted|Safety Set includes all subjects from N01221 [NCT00280696] and N01020 [NCT00160615] administered the investigational products at least once.||participants|||Number
728523|NCT00367484|Primary|Number of Participants Testing Positive for Neutralising Antibody (NAb)|Participants who were NAb+ at 48 weeks (or at the last available NAb assessment up to Week 48). The NAb+ value was defined as NAb ≥ 20 NU/ml.|48 Weeks|Intent To Treat (ITT) population, Last Observation Carried Forward (LOCF)||NAb+ participants|||Number
728524|NCT00367601|Secondary|Overall Survival||12 months|||months||95% Confidence Interval|Median
728525|NCT00367601|Secondary|Time to Progression||12 months|||months||95% Confidence Interval|Median
728526|NCT00367601|Primary|To Establish Rate of Non-progressive Disease at 4 Months in Patients With Advanced NSCLC Who Have Been Designated PS2 by Their Treating Physician||4 months|||percentage of participants|||Number
728527|NCT00367640|Primary|Average Rhinoconjunctivitis Total Symptom Score|"Average Rhinoconjunctivitis Total Symptom Score during the pollen period while participant on treatment.
Participants assessed daily, during the pollen period, 6 rhinoconjunctivitis symptoms (sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes) each symptom is scored as follows: 0: no symptoms, 1: mild symptoms, 2: moderate symptoms, 3: severe symptoms. The sum of the 6 symptoms is the Rhinoconjunctivitis Total Symptom Score (RTSS) (range 0-18). The lower the score, the better the outcome."|Pollen period (average of 32 days in the ITT set)|The intent-to-treat (ITT) population included all patients who received at least one dose of investigational product and had a Retrospective Rhinoconjunctivitis Total Symptom Score (RRTSS) and at least one Rhinoconjunctivitis Total Symptom Score (RTSS) in the pollen period while on treatment.||Units on a scale (range: 0 to 18)||Standard Deviation|Mean
728528|NCT00367679|Secondary|Ratio of Post- to Pretreatment Expression Levels for Each of the Indicated Pazopanib Target Proteins|Baseline and post-therapy plasma samples were obtained from participants. Immunohistochemistry analyses were carried out using a BioPlex 200 machine (Bio-Rad) or by enzyme-linked immunoassays to evaluate levels of angiogenesis-related proteins and other relevant proteins. Post- and pre-treatment changes in cytokines and angiogenic factors in response to pazopanib were analyzed. A negative value indicates that the post-treatment level of the particular target protein was less than the pre-treatment level.|Baseline to at least two weeks and at most 6 weeks|Safety population: all participants who received at least one dose of pazopanib. Only 33 of 35 subjects had plasma samples from both pre- and post-treatment available for analysis.||ratio||Inter-Quartile Range|Median
728529|NCT00367679|Secondary|Semiquantitative Levels of Staining in Pre-treatment Tumor Biopsies (e.g. VEGF, VEGFR-1,VEGFR-2).|Analysis not performed as part of study. Appropriate material was not available for analysis.|Entire study interval|Safety Population: all participants who received at least one dose of pazopanib||Relative luminescence units||Standard Deviation|Mean
728530|NCT00367679|Secondary|Genetic Variations in Germline DNA|Plasma samples were collected from each consenting participant, generally at baseline, to permit evaluation of the presence or absence of genetic variations in select candidate genes in germline DNA. Analyses that could have been done might have examined the relationship between genetic variants and the safety or tolerability or the efficacy of pazopanib. Analyses have not yet been conducted, but a need to do so may yet be identified. The clinical study report indicated that results, if any, would be reported separately.|Baseline|Safety Population: all participants who received at least one dose of pazopanib||Sum of changes in gene (DNA) sequences||Standard Deviation|Mean
728531|NCT00367679|Secondary|Plasma Levels of Lactate Dehydrogenase-5 (LDH5)|LDH5 has been shown to be associated with activation of angiogenesis in lung cancer. Circulating levels of LDH5 were to have been measured at each scheduled visit through the post-treatment visit to determine if a correlation with drug effect existed. Levels of LDH5 were measured, but the team determined that greater value was to be derived from transcriptional and plasma biomarker analyses; thus, no analyses were conducted to examine the correlation of LDH5 levels with effects of pazopanib.|Baseline to at least three weeks and at most 8 weeks|Safety Population: all participants who received at least one dose of pazopanib||Units/Liter||Standard Deviation|Mean
728532|NCT00367679|Secondary|Intratumoral Levels of Specific Biomarkers|A pre-treatment tumor biopsy from each participant was to have been analyzed by Western blotting to semi-quantitate levels of various proteins related to angiogenesis and/or to the mechanism of action of pazopanib. These assays were not carried out due to insufficient quantity of tissue present in the pre-treatment biopsy (fine needle aspirate). The clinical study report indicates that results were to have been reported separately.|Baseline tumor biopsy|Safety Population: all participants who received at least one dose of pazopanib||nanograms/milliliter||Standard Deviation|Mean
728533|NCT00367679|Secondary|Gene Mutations in Pre- or Post-treatment Tumor Biopsies|Specific genes (KRAS, MYC, TP53, and others) were to have been analyzed for the presence or absence of amplifications or deletions and for the presence, absence, and sequence of point mutations in pre- or post-treatment tumor biopsies. These analyses were not conducted because the potential results were considered to provide overlapping information with those obtained in the transcriptional and proteomic profiling assays that were conducted. The clinical study report indicates that genetic measures were to have been reported separately.|Baseline to at least three weeks and at most 8 weeks (surgery date)|Safety Population: all participants who received at least one dose of pazopanib||Number of DNA sequence changes||Standard Deviation|Mean
728550|NCT00367835|Secondary|Change From Baseline in Electrocardiogram Results (QTcF Interval) at Up to 8 Weeks|QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate (e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.|Baseline and up to 8 weeks|Safety population defined as all randomized subjects who received at least one dose of any investigational product during this study.||msec||Standard Deviation|Mean
729759|NCT00383110|Secondary|Diastolic Blood Pressure||12-months after enrollment|Discrepancies in number of participants analyzed is due to some participants having no data in their medical record for this measure.||mmHg||Standard Deviation|Mean
728534|NCT00367679|Secondary|Ratio of Post- to Pretreatment Expression Levels for Each of the Indicated Pazopanib Target Genes|Gene expression data analysis was performed with GeneSpring GX 7.3.1 (Agilent Technologies). Data were preprocessed using the RMA algorithm. The Benjamini and Hochberg false discovery rate was used for multiple testing corrections. Data below are log-transformed ratios of the post-treatment to pre-treatment expression intensity, indicating the fold increase/decrease in expression of genes. PDGF, platelet-derived growth factor; VEGFR, vascular endothelial growth factor receptor; c-KIT, a protein tyrosine kinase that is a receptor for stem cell factor or “kit” ligand.|Baseline to at least three weeks and at most 8 weeks (surgery date)|Tumor tissue from Safety Population: all participants who received at least one dose of pazopanib. Only 26 of 35 subjects had sufficient tissue in both pre- and post-treatment samples for analysis.||ratio||Standard Deviation|Median
728535|NCT00367679|Secondary|Number of Cells Exhibiting Apoptosis in Participant Samples|Tumor cells from pre-treatment and post-operative biopsies were to have been analyzed to determine the number of cells that were exhibiting apoptosis. Due to the limited quantity of tissue in pre- and post-treatment biopsy samples, these assays were not performed.|Baseline to at least three weeks and at most 8 weeks (surgery date)|Tissue from Safety Population: all participants who received at least one dose of pazopanib||number of cells||Standard Deviation|Mean
728536|NCT00367679|Secondary|Number of Participants With the Indicated Change From Baseline in Systolic and Diastolic Blood Pressure|Increases in systolic or diastolic blood pressure values at any point in the study following baseline were summarized. mmHg = millimeters of mercury. Baseline blood pressure values as well as the change from baseline experienced are given in the category titles.|Baseline to at least three weeks and at most 8 weeks|Safety Population||participants|||Number
728537|NCT00367679|Secondary|Number of Participants With Shifts From Baseline to Grade 2 or Greater in Chemistry Values|Shifts in chemistry values by grade were summarized based on the NIH Common Terminology Criteria for Adverse Events (Version 3.0 – definitions provided with each parameter below). Shifts to Grade 2 or greater at any point in the study following baseline are reported here. ULN = upper limit of normal; Gr = grade; mg = milligrams; dL = deciliter; mmol = millimoles.|Baseline to at least three weeks and at most 8 weeks|Safety Population||participants|||Number
728538|NCT00367679|Secondary|Number of Participants With Shifts From Baseline to Grade 2 or Greater in Hematology Values|Shifts in hematology values by grade were summarized based on the National Institutes of Health (NIH) Common Terminology Criteria for Adverse Events (Version 3.0 – definitions provided with each parameter below). Shifts to Grade 2 or greater at any point in the study following baseline are reported here.|Baseline to at least three weeks and at most 8 weeks|Safety Population||participants|||Number
728539|NCT00367679|Secondary|Number of Participants Achieving a >=60% Reduction in Tumor Metabolic Activity Determined as Standard Uptake Value (SUV)|Response is the number of participants whose tumor demonstrated a 60% or greater reduction in metabolic activity (SUV) as measured by positron emission tomography (PET) or PET/computed tomography (PET/CT) at the end of treatment visit relative to baseline. This analysis was not conducted because insufficient data were collected: only three participants had PET/CT data.|Baseline to at least two weeks or at most six weeks|Safety Population: all participants who received at least one dose of pazopanib||participants|||Number
728540|NCT00367679|Secondary|Number of Participants Achieving a Clinical Response Based on RECIST|Response is the number of participants achieving either complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR, all detectable tumor has disappeared; PR, a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum; Progressive disease (PD), a >=20% increase in target lesions; Stable Disease, small changes not meeting previously given criteria. Confirmation requires at least 2 assessments (conducted by a central reviewer) of CR/PR with at least 4 weeks between the assessments.|Baseline to at least two weeks or at most six weeks|Safety population: all participants who received at least one dose of pazopanib||participants|||Number
728541|NCT00367679|Primary|Number of Participants Achieving Tumor Shrinkage Based on Change in Tumor Volume|"Tumor shrinkage was assessed as the change in tumor volume using high-resolution computed tomography scans of the thorax following treatment with pazopanib. Response is defined as the number of participants achieving at least 50% tumor volume reduction following pazopanib treatment. Responder is a participant whose tumor volume reduced at least 50% following pazopanib treatment. Non-responder is a participant whose tumor volume did not reduce at least 50% following treatment. Tumor assessments were conducted by a central reviewer."|Baseline to at least two weeks or at most six weeks|Safety Population: all participants who received at least one dose of pazopanib||participants|||Number
728542|NCT00367744|Secondary|the Change in the Carotid IMT of the Common Carotid Artery|Carotid IMT of the Common carotid artery (CCA) was measured at baseline and week 48, and change from baseline to week 48 (week 48 - baseline) was estimated for the treatment groups.|48 weeks|Intention to treat analysis with last observation carried forward if week 48 carotid IMT data was missing and post-baseline IMT data was available||mm||Inter-Quartile Range|Median
728543|NCT00367744|Primary|Change in Limb Fat at 48 Weeks|Limb fat was measured at baseline and visit week 48 using dual-energy x-ray absorptiometry (DEXA), and change from baseline to week 48 (week 48 - baseline) was estimated for the treatment groups.|48 weeks|Intention to treat analysis with last observation carried forward if week 48 limb fat data was missing and post-baseline limb fat was availble.||grams||Inter-Quartile Range|Median
728544|NCT00367770|Primary|Number of Participants With a Change in WHO Functional Class|"Number of participants with a change in WHO functional class from baseline to week 24.
A change from a higher to a lower functional class (i.e. III to II, III to I or II to I) is considered as an improvement."|from baseline to week 24|The analysis was done in the safety set.||participants|||Number
728545|NCT00367770|Primary|Change in Borg Dyspnea Index|Borg scale a numerical scale for assessing dyspnea, from 0 representing no dyspnea to 10 as maximal dyspnea.|from baseline to week 24|The analysis was done in the safety set.||units on a scale||Standard Deviation|Mean
728546|NCT00367770|Primary|Change in 6-minute Walk Distance||from baseline to week 24|The analysis was done in the safety set.||m||Standard Deviation|Mean
728547|NCT00367835|Secondary|Change From Baseline in Diastolic Blood Pressure at Up to 8 Weeks||Baseline and up to 8 weeks|Safety population||mmHg||Standard Deviation|Mean
728548|NCT00367835|Secondary|Change From Baseline in Systolic Blood Pressure at Up to 8 Weeks||Baseline and up to 8 weeks|Safety population||mmHg||Standard Deviation|Mean
728551|NCT00367835|Secondary|Number of Participants With Overall Satisfaction on the Medication Satisfaction Survey (MSS)|"The Medication Satisfaction Survey (MSS) consists of 11 questions each being answered with one of six responses (strongly agree, agree, somewhat agree, somewhat disagree, disagree, strongly disagree). Overall satisfaction with their child taking the study medication, Question #11, with a response of strongly agree or agree."|up to 8 weeks|FAS||Participants|||Number
728552|NCT00367835|Secondary|Change From Baseline in the Parent Stress Index-Short Form (PSI/SF) Score at Up to 8 Weeks|The response to each of the 36 items on the PSI/SF is converted to a five-point scale from 1 (strongly agree) to 5 (strongly disagree) with total scores ranging from 36 to 180. A higher score is reflective of less stress for the parents.|Baseline and up to 8 weeks|FAS||Units on a scale||Standard Deviation|Mean
728553|NCT00367835|Secondary|Change From Baseline in the 40-Item Conduct Problem Scale of the New York Parent's Rating Scale-School-aged (NYPRS-S) Score at Up to 8 Weeks|Each item on the NYPRS-S is scored from a range of 0 (not at all) to 3 (very much) with total scores ranging from 0 to 120. Higher scores are reflective of increased disease severity.|Baseline and up to 8 weeks|FAS||units on a scale||Standard Deviation|Mean
728554|NCT00367835|Secondary|Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I)|CGI-I consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|up to 8 weeks|FAS||Participants|||Number
728555|NCT00367835|Secondary|Assessment of Clinical Global Impression-Severity of Illness (CGI-S)|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|up to 8 weeks|FAS||Participants|||Number
728556|NCT00367835|Secondary|Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Total Score at Up to 8 Weeks|The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|Baseline and up to 8 weeks|FAS||Units on a scale||Standard Deviation|Mean
728557|NCT00367835|Primary|Change From Baseline in the Oppositional Subscale of the Conners' Parent Rating Scale-Revised Long Form (CPRS-R:L) Score at Up to 8 Weeks|The oppositional subscale of the CPRS-R:L contains 10 items designed to reflect criteria for oppositional defiance disorder (ODD). Each item is scored on a range from 0 (not true at all) to 3 (very much true) with total scores ranging from 0 to 30. Higher scores are reflective of more severe symptoms.|Baseline and up to 8 weeks|Full Analysis Set (FAS) defined as all randomized subjects who received at least one dose of any investigational product during this study and with a baseline and at least one post-baseline efficacy measurement.||Units on a scale||Standard Deviation|Mean
728558|NCT00367991|Secondary|Circulating Endothelial Progenitor Cells||Day 3 and Day 10||||||
728559|NCT00367991|Secondary|Serum Markers of Myocyte Damage and Apoptosis||Day 1 and Day 10||||||
728560|NCT00367991|Secondary|Left Ventricular Ejection Fraction||Day 1 and Day 10||||||
728561|NCT00367991|Primary|Platelet Function Assay Closure Time||Day 3 and Day 10||||||
728562|NCT00367991|Primary|Bleeding Time|An integrated measure of in vivo platelet function and tissue hemostasis|Day 3 and Day 10|ITT||seconds||Inter-Quartile Range|Median
728563|NCT00368069|Primary|Partial Onset Seizure (POS) Frequency Per Week - Per Protocol (PP) Population|Number of POS over the treatment period standardized to 1 week period|Treatment Period (12 weeks)|Per Protocol (PP) Population (Analyses were performed on subjects from the PP Population with non-missing information during both baseline and treatment period)||seizures per week (log-transformed data)||Standard Error|Least Squares Mean
728564|NCT00368069|Secondary|Response in Weekly POS Frequency (Categorized Into 6 Categories According to Reduction) Over the Treatment Period of 12 Weeks|The response is classified according to the percent reduction from baseline in the POS frequency per week over the Treatment Period of 12 weeks duration.|over the treatment period (12 weeks)|ITT Based on the number of evaluable patients. A patient is considered as evaluable for the response status if he has seizure information in at least one of the periods (baseline or treatment period).||Participants|||Number
728565|NCT00368069|Secondary|50% Response in Weekly POS Frequency|A subject is considered as a 50% responder in POS if he/she has a >= 50% decrease from Baseline in the POS frequency/week over Treatment period.|Treatment period (12 weeks)|ITT Based on the number of evaluable patients. A patient is considered as evaluable for the response status if he has seizure information in at least one of the periods (baseline or treatment period)||Participants|||Number
728566|NCT00368069|Secondary|All (Type I+II+III) Seizures Frequency Per Week|Number of All type Seizures over the treatment period standardized to 1 week period (Type I -Partial Onset Seizures, Type II - Generalized Seizures, Type III - Unclassified Epileptic Seizures)|Treatment period (12 weeks)|ITT (Analyses were performed on subjects from the ITT with non-missing information during baseline and treatment period.)||seizures per week (log-transformed data)||Standard Error|Least Squares Mean
728567|NCT00368069|Secondary|POS Seizure Frequency Per Week Over Baseline and Treatment Period||Baseline Period (8 weeks) - Treatment Period (12 weeks)|ITT Population - no imputation techniques used for missing data (number of subjects with non-missing data for Baseline = ITT Population and for Treatment period = 75 patients for Levetiractam and 78 patients for PBO) Clusters of type I count are included in the count of Type I seizures||seizures per week||Inter-Quartile Range|Median
728568|NCT00368069|Primary|Partial Onset Seizure (POS) Frequency Per Week - Intention-To-Treat (ITT) Population|Number of POS over the treatment period standardized to 1 week period.|Treatment period (12 weeks)|Intention-to-treat (ITT) (Analyses were performed on subjects from the ITT with non-missing information during baseline and treatment period.)||seizures per week (log-transformed data)||Standard Error|Least Squares Mean
728569|NCT00368108|Secondary|Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) to Week 20 (Including LOCF Data)|Patients described themselves in home diaries every 30 minutes during waking hours for 3 days prior to Baseline, Weeks 8, 12, 16, and 20. ON state is when medication is providing benefits to stiffness, slowness, and tremor.|Baseline and Week 20|ITT Population||Hours||95% Confidence Interval|Least Squares Mean
728582|NCT00368290|Primary|Cocaine Use as Measured by Urine Drug Screen|The primary outcome measure was cocaine use measured by self-report, and confirmed by twice weekly urine drug screens. The percentage of participants shows the percentage who were abstinent from cocaine during the last 3 weeks of the trial.|8 weeks|||Percentage of Participants|||Number
728570|NCT00368108|Secondary|Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) to Week 20 (Including LOCF Data)|Patients described themselves in home diaries every 30 minutes during waking hours for 3 days prior to Baseline, Weeks 8, 12, 16, and 20. UPDRS is a standardized assessment of the symptoms and signs of PD. Part III assesses motor activity, based on 14 items, such as gait, facial expression, and rigidity. Participants receive a score of 0-4 points per item, with a higher score indicating more severe symptoms. ON state is when medication is providing benefits to stiffness, slowness, and tremor.|Baseline and Week 20|ITT Population||Scores on a Scale||95% Confidence Interval|Least Squares Mean
728571|NCT00368108|Secondary|Mean Change From Baseline in Scale UPDRS Part II (ADL) Score in Total Daily OFF Time to Week 20 (Including LOCF Data)|Patients described themselves in home diaries every 30 minutes during waking hours for 3 consecutive days prior to Baseline, Weeks 8, 12, 16, and 20. Unified Parkinson's Disease (PD) Rating Scale (UPDRS) is a standardized assessment of the symptoms and signs of PD. Part II assesses Activities of Daily Living (ADL) based on 13 items, such as speech, hygiene, and falling. Participants receive a score of 0-4 points per item, with a higher score indicating more severe symptoms. Range of possible total scores, 0 to 52. ON state is when medication is providing benefits to mobility, slowness, and stiffness. OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor.|Baseline and Week 20|ITT Population||Scores on a scale||95% Confidence Interval|Least Squares Mean
728572|NCT00368108|Primary|Mean Change From Baseline in Total Daily OFF Time (Hours) to Week 20 (Including Last Observation Carried Forward [LOCF] Data)|"Patients described themselves in home diaries as OFF, ON without dyskinesias, ON with non troublesome dyskinesias, ON with troublesome dyskinesias, or Asleep, every 30 minutes during waking hours for 3 consecutive days prior to Baseline, Weeks 8, 10, 18, and 20. OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor."|Baseline and Week 20|The Intent-to-treat (ITT) Population for diary data consisted of all subjects who were randomized to either perampanel or placebo, had taken at least 1 dose, had a valid, nonmissing Baseline diary measurement and at least 1 valid, non-missing, postbaseline diary measurement at Last Observation Carried Forward (LOCF).||Hours||95% Confidence Interval|Least Squares Mean
728573|NCT00368251|Secondary|Global Evaluation Score (Investigator) at the End of Treatment Period|The Global Evaluation Scale Score (Investigator) ranges from 1 (Marked worsening) to 7 (Marked improvement).|End of Treatment Period (Week 14 or Early Discontinuation Visit)|The number of subjects is equal to the number of subjects in the Intent-To-Treat (ITT) population having non-missing post-baseline results for the Global Evaluation Score (I-GES). In case a subject drops out, the result at Early Discontinuation Visit (EDV) is used.||percentage of participants|||Number
728574|NCT00368251|Secondary|Percent Change From Baseline to the End of Treatment Period on the Myoclonus Patient Questionnaire (Unified Myoclonus Rating Scale (UMRS) Section 1)|The range for Myoclonus Patient Questionnaire is 0 (best) to 44 (worst). Percent change from Baseline = 100 X ((Baseline UMRS1 - Treatment UMRS1) / Baseline UMRS1). Baseline is defined as the last non-missing value prior to or on Randomization Visit.|Baseline to End of Treatment Period (Week 14 or Early Discontinuation Visit)|The number of subjects is equal to the number of subjects in the Intent-To-Treat (ITT) population having non-missing post-baseline results for the percent change from baseline on the Myoclonus Patient Questionnaire (UMRS section 1). In case a subject drops out, the result at Early Discontinuation Visit (EDV) is used.||Percent change||Full Range|Median
728575|NCT00368251|Secondary|Percent Change From Baseline to the End of Treatment Period on the Stimulus Sensitivity Score (Unified Myoclonus Rating Scale (UMRS) Section 3)|The range for Stimulus Sensitivity Score is 0 (best) to 17 (worst). Percent change from Baseline = 100 X ((Baseline UMRS3 - Treatment UMRS3) / Baseline UMRS3). Baseline is defined as the last non-missing value prior to or on Randomization Visit.|Baseline to End of Treatment Period (Week 14 or Early Discontinuation Visit)|The number of subjects is equal to the number of subjects in the Intent-To-Treat (ITT) population having non-missing post-baseline results for the percent change from baseline on the stimulus sensitivity score (UMRS section 3). In case a subject drops out, the result at Early Discontinuation Visit (EDV) is used.||Percent change||Full Range|Median
728576|NCT00368251|Secondary|Percent Change From Baseline to the End of Treatment Period on the Functional Disability Score (Unified Myoclonus Rating Scale (UMRS) Section 5)|The range for Functional Disability Score is 0 (best) to 28 (worst). Percent change from Baseline = 100 X ((Baseline UMRS5 - Treatment UMRS5) / Baseline UMRS5). Baseline is defined as the last non-missing value prior to or on Randomization Visit.|Baseline to End of Treatment Period (Week 14 or Early Discontinuation Visit)|The number of subjects is equal to the number of subjects in the Intent-To-Treat (ITT) population having non-missing post-baseline results for the percent change from baseline on the functional disability score (UMRS section 5). In case a subject drops out, the result at Early Discontinuation Visit is used.||Percent change||Full Range|Median
728577|NCT00368251|Primary|Percent Change From Baseline to the End of Treatment Period on the Action Myoclonus Score (Unified Myoclonus Rating Scale (UMRS) Section 4)|The range for Action Myoclonus Score (centrally read) is 0 (best) - 160 (worst). Percent change from Baseline = 100 X ((Baseline UMRS4 - Treatment UMRS4) / Baseline UMRS4). Baseline is defined as the last non-missing value prior to or on Randomization Visit.|From Baseline to End of Treatment Period (Week 14 or Early Discontinuation Visit)|The number of subjects is equal to the number of subjects in the Intent-To-Treat (ITT) population having non-missing post-baseline results for the percent change from baseline on the functional disability score (UMRS section 5). In case a subject drops out, the result at Early Discontinuation Visit is used.||Percent change||Full Range|Median
728578|NCT00368277|Secondary|Change From Baseline in the Mean Sitting Diastolic Blood Pressure to Week 36||Baseline and week 36|Intent to treat (ITT), Last Observation Carried forward (LOCF)||mm Hg||Standard Error|Least Squares Mean
728579|NCT00368277|Secondary|Percentage of Patients Achieving Blood Pressure Control at Weeks 12 and 36 Endpoints|Blood pressure control is defined as a mean sitting blood pressure < 140/90 mm Hg|Weeks 12 and 36|intent to treat (ITT), last observation carried forward (LOCF)||Percentage of participants|||Number
728580|NCT00368277|Secondary|Percentage of Patients With Cough||Weeks 12 and 36|Safety population||Percentage of Participants|||Number
728581|NCT00368277|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure to Week 12||Baseline and Week 12|Intent to treat (ITT), Last Observation Carried forward (LOCF)||mm Hg||Standard Error|Least Squares Mean
728585|NCT00368316|Secondary|Geometric Mean Immunoglobulin G (IgG) Anti-Lipopolysaccharide (LPS) Levels|Age-related homologous IgG anti-LPS levels|Injections were administered 6 weeks apart and IgG anti-LPS levels determined >2 weeks after second vaccine dose. Each of the 15 sites also took a sample/week randomly chosen, for 2 years of follow up and blood samples from patients with disease|||ELISA units||95% Confidence Interval|Geometric Mean
728586|NCT00368316|Primary|Number of Participants With Adverse Events|Number of participants with events per vaccine type and dose occuring in >=5% of participants|Monitored for 7 days per participant following each injection for initial group of 500, 2 days for extended study of up to 5500 additional children|||participants|||Number
728587|NCT00368459|Secondary|Cognition (Neuropsychological)|Global composite calculated as a weighted average of standardized scores of neuropsychological tests (weighted by the inverse intertest correlation matrix), change from baseline at 6 months. There is no theoretical maximum or minimum for this cognitive composite, with a score of 0 standardized units representing no change. For results below, positive change represents improvement/ better performance.|6 months|||units on a scale||Standard Deviation|Mean
728588|NCT00368459|Secondary|Behavior|Neuropsychiatric Inventory, change from baseline at 6 months, compared between groups. Range 0-120. For results below, positive change represents improvement/ better performance.|6 months|||units on a scale||Standard Deviation|Mean
728589|NCT00368459|Secondary|Function, Activities of Daily Living|Change from baseline at 6 months, compared between groups. Range 0-78. For results below, positive change represents improvement/ better performance.|6 months|||units on a scale||Standard Deviation|Mean
728590|NCT00368459|Secondary|Clinical Dementia Rating, Sum of Boxes|Change from baseline at 6 months, compared between groups. Range 0-5. For results below, positive change represents improvement/ better performance.|6 months|||units on a scale||Standard Deviation|Mean
728591|NCT00368459|Secondary|ADAS-cog|Change from baseline at 6 months, compared between groups. Error score range 0-70. For results below, positive change represents improvement/ better performance.|6 months|||units on a scale||Standard Deviation|Mean
728592|NCT00368459|Secondary|Cognitive (Neuropsychological)|Global composite calculated as a weighted average of standardized scores of neuropsychological tests (weighted by the inverse intertest correlation matrix), change from baseline at 12 months. There is no theoretical maximum or minimum for this cognitive composite, with a score of 0 standardized units representing no change. For results below, positive change represents improvement/ better performance.|12 months|||units on a scale||Standard Deviation|Mean
728593|NCT00368459|Secondary|Behavior|Neuropsychiatric Inventory, change from baseline at 12 months. Range 0-120. For results below, positive change represents improvement/ better performance.|12 months|||units on a scale||Standard Deviation|Mean
728594|NCT00368459|Secondary|Function, Activities of Daily Living (ADL)|ADL scale from the Alzheimer's Disease Cooperative Study, change from baseline at 12 months. Range 0-78. For results below, positive change represents improvement/ better performance.|12 months|||units on a scale||Standard Deviation|Mean
728595|NCT00368459|Secondary|Global Rating, Clinical Dementia Rating (CDR) Sum of Boxes|Global rating of dementia severity, change from baseline at 12 months. Range 0-5. For results below, positive change represents improvement/ better performance.|12 months|||units on a scale||Standard Deviation|Mean
728596|NCT00368459|Primary|Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-cog)|"ADAS-cog, change from baseline at 12 months, compared between treatment arms. The ADAS-cog is a neuropsychological battery commonly used in trials of AD patients. Error score range 0-70. For results below, positive change represents improvement/ better performance.
For the primary outcome, as well as for secondary outcomes, the reported p-values reflect the calculated p-values."|12 months|Intent-to-treat||units on a scale||Standard Deviation|Mean
728597|NCT00368472|Secondary|Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-perampanel Baseline|Seizure frequency was derived from information (seizure count and type) recorded in participant diary. The percentage of participants who experienced a 50% or greater reduction in seizure frequency per 28 days relative to the pre-perampanel Baseline (responders) was assessed. For participants who had been assigned to treatment with perampanel (previous treatment), pre-perampanel Baseline referred to the Prerandomization Phase of the Core Double Blind study. For participants who had been assigned to treatment with placebo (previous treatment), pre-perampanel Baseline was computed from all data during the Core Double Blind study (including Prerandomization Phase) prior to treatment with perampanel. The data is presented as percent responders.|Baseline up to week 221|The analysis was based on the Full Intent to Treat (ITT) Analysis Set, defined as participants who received at least 1 dose of open-label perampanel and had valid seizure data during the OLE study.||Percent responders|||Number
728598|NCT00368472|Secondary|Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline|Seizure frequency was derived from information (seizure count and type) recorded in participant diary. The seizure frequency per 28 days was calculated as the number of seizures divided by the number of days in the interval and multiplied by 28. The percent change in 28-day seizure frequency from baseline was assessed for all partial-onset seizures types. For participants who had been assigned to treatment with perampanel (previous treatment), pre-perampanel Baseline referred to the Prerandomization Phase of the Core Double Blind study. For participants who had been assigned to treatment with placebo (previous treatment), pre-perampanel Baseline was computed from all data during the Core Double Blind study (including Prerandomization Phase) prior to treatment with perampanel.|Baseline up to Week 221|The analysis was based on the Full Intent to Treat (ITT) Analysis Set, defined as participants who received at least 1 dose of open-label perampanel and had valid seizure data during the OLE study.||Percent Change||Full Range|Median
728610|NCT00368745|Secondary|Time to First Use of Rescue Medication|The 25th percentile estimate of time until first use of rescue medication is based on Kaplan-Meier estimates. Event day is the study day when the subject first used rescue medication. Rescue medication: packet with 2 doses alprazolam to take only in the event subject experiences severe symptoms of benzodiazepine withdrawal or rebound anxiety.|Baseline, Week 13 (Final Visit/Early Termination)|ITT; Week 13 (Final Visit/Early Termination) or LOCF||days|||Number
728611|NCT00368745|Secondary|Time to Discontinuation|The 25th percentile estimate of time until discontinuation is based on Kaplan-Meier estimates. Event day is the study day when the subject discontinued from study.|Baseline, Week 13 (Final Visit/Early Termination)|ITT; Week 13 (Final Visit/Early Termination) or LOCF.||days|||Number
728599|NCT00368472|Primary|Number of Participants With Treatment-emergent Non-serious Adverse Events (AEs) and Treatment-emergent Serious Adverse Events (SAEs)|An AE was defined as any untoward medical occurrence in a clinical investigation participant administered an investigational product. A SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening (ie, the participant was at immediate risk of death from the AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was as a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). In this study, treatment emergent AEs (defined as an AE (serious or non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed. The data is presented in the safety section of the results.|From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years|Safety Analysis Set was defined as participants who received at least 1 dose of open-label perampanel and had at least 1 safety assessment after the first dose of perampanel in the OLE study.||Participants|||Number
728600|NCT00368537|Secondary|Inpatient Healthcare Resource Utilization on or Before Test-of-Cure - Number of Patients|Healthcare resource utilization assessment included intensive care unit (ICU) and non-ICU inpatient hospitalization. TOC performed 8-50 days after last dose of study drug.|up to 6 weeks|All patients who received at least 1 dose of study article.||participants|||Number
728601|NCT00368537|Secondary|Minimum Inhibitory Concentration (MIC) 50 and 90 by Baseline Isolate|In vitro activity of the study drugs against a range of pathogenic bacteria that cause complicated skin and skin structure infection (cSSSI) were analyzed using MIC. MIC 50 and MIC 90 are the lowest concentrations of a drug that inhibit the growth of 50% and 90% of a microorganism, respectively. TOC performed 8-50 days after last dose of study drug.|up to 6 weeks|"m-mITT: Patients with ≥1 dose of study drug, had cSSSI and baseline isolate from infection site / blood. MIC reported for isolates present in ≥10 m-mITT patients. In the categories below n is the actual number of isolates used to caluculate the MIC 50 and MIC 90."||mcg/mL|||Number
728602|NCT00368537|Secondary|Number of Microbiologically Evaluable Patients by Microbiologic Response at Test-of-Cure (TOC) Visit|Microbiological response assessed at patient level. Eradication=baseline isolate not present in repeat culture from the original infection site; Presumed Eradication=clinical response of cure precluded the availability of a specimen for culture; Persistence=baseline isolate present in repeat culture from the original infection site; Presumed Persistence=culture data not available for patients with a clinical response of failure; Superinfection=culture from the primary infection site had new pathogen not identified as a baseline isolate and clinical response was failure.|up to 6 weeks|Microbiologically Evaluable patients:CE patients who had baseline culture with ≥1 identified pathogen susceptible to both study drugs (ie, the pathogen is susceptible to tigecycline and comparator). TOC performed 8-50 days after last dose of study drug.||participants|||Number
728603|NCT00368537|Secondary|Number of Microbiologically Evaluable Patients With Clinical Response of Cure at the Test-of-cure (TOC) Visit|Investigator assigned clinical response of cure of the cSSSI defined as: resolution of all clinical signs and symptoms of infection (healing of chronic underlying skin ulcer not required) or improvement of signs or symptoms of the infection to such an extent that no further antibacterial therapy was necessary. ME population were subjects who were CE and had baseline culture with at least 1 identified isolate that was susceptible to study drug and comparator. TOC performed 8-50 days after last dose of study drug.|up to 6 weeks|Microbiologically Evaluable patients:Clinically Evaluable (CE) patients who had baseline culture with ≥1 identified pathogen susceptible to both study drugs (ie, the pathogen is susceptible to tigecycline and comparator). Excludes indeterminates.||participants|||Number
728604|NCT00368537|Primary|Number of Clinically Evaluable (CE) Patients With Clinical Response of Cure at the Test-of-cure (TOC) Visit|Investigator assigned clinical response of cure of the cSSSI defined as: resolution of all clinical signs and symptoms of infection (healing of chronic underlying skin ulcer not required) or improvement of signs or symptoms of the infection to such an extent that no further antibacterial therapy was necessary. CE population were those who completed TOC assessment of cure or failure (but not indeterminate) or, in case of premature discontinuation due to lack of efficacy, had completed end of treatment assessment such that assessment of clinical response could be made.|up to 6 weeks|Clinically Evaluable (CE): Patients with cSSSI, no Pseudomonas aeruginosa as sole baseline isolate, met major inclusion/exclusion criteria, ≤24 hrs antibiotics pre-baseline, had ≥4 days of study drug, compliant with therapy. Excludes indeterminates.||participants|||Number
728605|NCT00368550|Secondary|Change in the Level of Alcohol-related Problems|Measured using the SIP (Short Inventory of Problems), which was administered at pretreatment and at the end of treatment. The range of scores on the SIP is 0 (no alcohol-related problems) to 45 (most severe alcohol-related problems) and the time frame for reporting is the preceding 3 months. The data presented here represent a difference score of treatment minus baseline.|12-week treatment period compared with baseline value|||Units on a scale||Standard Deviation|Mean
728606|NCT00368550|Secondary|Number of Days of Heavy Drinking (Defined as Days on Which Women Drank >= 4 Drinks and Men Drank >= 5 Drinks)|Obtained using daily interactive voice response data augmented by Timeline Followback data. Missing days were treated as heavy drinking days.|12-week treatment period|||days||Standard Deviation|Mean
728607|NCT00368550|Primary|Number of Days on Which Subjects Drank|Obtained using daily interactive voice response data augmented by Timeline Followback data. Missing days were treated as drinking days.|12-week treatment period|All randomized subjects with missing days imputed as drinking days.||days||Standard Deviation|Mean
728608|NCT00368641|Primary|All-cause Hospitalization (Unadjusted)|All-cause hospitalization was defined as (1) hospitalization for any cause of any duration or (2)any ER visit or any clinic visit specifically for congestive heart failure requiring intravenous administration of an inotrope, vasodilator or diuretic.|6 to 24 months|intent to treat population||hospitalizations per year||95% Confidence Interval|Mean
728609|NCT00368745|Secondary|Number of Subjects in Relapse Free State at 6-week Benzodiazepine-free Endpoint (Alprazolam Free Week 6)|Number of subjects benzodiazepine free: < 2 doses rescue medication; negative urine toxicology assay (each visit Alprazolam Free phase), negative urine alcohol assay (Alprazolam Free Week 6 = endpoint or LOCF). Relapse: > = 2 intakes rescue medication, positive urine and /or alcohol assays, unable to tolerate alprazolam taper, or discontinuation.|Alprazolam Free Week 6|ITT; endpoint = AF Week 6 or LOCF.||participants|||Number
728612|NCT00368745|Secondary|Mean Change From Baseline in Digit Symbol Substitution Test (DSST) Scores|DSST: subject-rated; evaluates aspects of cognition (includes attending to directions, processing speed, sustained attention, visual-motor integration, learning and psychomotor speed). Subject matches symbol (1 to 9) with corresponding number key (1 to 9); number of correct symbol-number pairs completed by subject over a 90-second test period determines DSST score. Change: mean at observation minus mean at baseline. Data summarized as change from baseline to endpoint.|Baseline, Endpoint (AF Week 6 )|ITT; subject has baseline and endpoint (final visit) measurement; endpoint = AF Week 6 or LOCF.||scores on scale||Standard Error|Least Squares Mean
728613|NCT00368745|Secondary|Mean Scores for Patient Global Impression-Improvement (PGI-I)|PGI-I: subject rated 7-point scale measures change in overall status; range 1 (very much improved) to 7 (very much worse).|Alprazolam Taper Weeks 1 through 6, Alprazolam Free Weeks 1 through 6, and Endpoint (AF Week 6 )|ITT; endpoint = AF Week 6 or LOCF; (n) = number of subjects with data for analysis for pregabalin and placebo, respectively.||scores on scale||Standard Error|Least Squares Mean
728614|NCT00368745|Secondary|Mean Scores for Clinical Global Impression-Improvement (CGI-I) Scale|CGI-I: 7-point scale to assess global change in subject condition compared to baseline; range 1 (very much improved) to 7 (very much worse); higher score = more affected.|Alprazolam Taper Weeks 1 through 6, Alprazolam Free Weeks 1 through 6, and Endpoint (AF Week 6 )|ITT; subject has a baseline and endpoint measurement; endpoint = AF Week 6 or LOCF; (n) = number of subjects with data for analysis for pregabalin and placebo, respectively.||scores on scale||Standard Error|Least Squares Mean
728615|NCT00368745|Secondary|Mean Change From Baseline in Clinical Global Impression Severity (CGI-S) Scale Scores.|CGI-S: 7-point scale to assess global change in subject condition compared to baseline; range 1 (no evidence of illness) to 7 (among the most severely ill); higher score = more affected. Change from baseline: mean at observation minus mean at baseline.|Baseline, Alprazolam Taper Weeks 1 through 6, Alprazolam Free Weeks 1 through 6, and Endpoint (AF Week 6 )|ITT; subject has a baseline and at least 1 post-baseline endpoint measurement; endpoint = AF Week 6 or LOCF; (n) = number of subjects with data for analysis for pregabalin and placebo, respectively.||scores on scale||Standard Error|Least Squares Mean
728616|NCT00368745|Secondary|Mean Change From Baseline in Physician's Withdrawal Checklist (PWC) Scores|PWC: 20 item physician rated interview (0 = not present; 3 = severe; score range: 0 to 60) measuring: signs of anxiolytic drug withdrawal and gastrointestinal (GI), mood, sleep, motor, somatic, perception and cognition symptoms. Change from baseline not analyzed as PWC was not measured at baseline. Mean PWS scores presented in Post-hoc outcome measure Mean PWS scores.|Baseline, Alprazolam Taper Weeks 1 through 6, Alprazolam Free Weeks 1 through 6, Endpoint (AF Week 6)|ITT; Change from baseline not analyzed as PWC was not measured at baseline. Mean PWS scores presented in Post-hoc outcome measure Mean PWS scores.||scores on scale||Standard Deviation|Mean
728617|NCT00368745|Post-Hoc|Mean Scores Physician's Withdrawal Checklist (PWC)|Mean scores at each visit for PWC: 20-item physician-rated interview measures presence of anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception, and cognition); range 0 (not present) to 3 (severe). Total score: 0 to 60; higher score = more affected. Mean scores entered as post-hoc analysis as Mean change from baseline in PWS scores not analyzed: PWS not measured at baseline.|Baseline, Alprazolam Taper Weeks 1 through 6, Alprazolam Free Weeks 1 through 6, Endpoint (AF Week 6 )|ITT; (n) = number of subjects with data for analysis for pregabalin and placebo, respectively. Endpoint = AF Week 6 or LOCF. Refer to measure Mean Change From Baseline in Physician's Withdrawal Checklist (PWC) Scores.||scores on scale||Standard Error|Least Squares Mean
728618|NCT00368745|Secondary|Number of Subjects With > = 5 New PWC Symptoms|PWC: 20 item physician rated interview (0 = not present; 3 = severe; score range: 0 to 60) measuring: signs of anxiolytic drug withdrawal and gastrointestinal (GI), mood, sleep, motor, somatic, perception and cognition symptoms. Data not analyzed: PWC not measured at baseline.|Baseline, Alprazolam Free Weeks 1 through 6, Endpoint (AF Week 6)|ITT; data not analyzed: PWC not measured at baseline.||particpants|||Number
728619|NCT00368745|Secondary|Number of Subjects With > = 6 Point Increase in Physician's Withdrawal Checklist (PWC) Scores|PWC: 20 item physician rated interview (0 = not present; 3 = severe; score range: 0 to 60) measuring: signs of anxiolytic drug withdrawal and gastrointestinal (GI), mood, sleep, motor, somatic, perception and cognition symptoms. Data not analyzed: PWC not measured at baseline.|Baseline, Alprazolam Free Weeks 1 through 6, Endpoint (AF Week 6)|ITT; data not analyzed: PWC not measured at baseline.||particpants|||Number
728620|NCT00368745|Secondary|Mean Change From Baseline in Hamilton Anxiety Scale (HAM-A) Scores|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); lower score indicates less affected. Change from baseline: mean at observation minus mean at baseline.|Baseline, Alprazolam Taper Weeks 1 through 6, Alprazolam Free Weeks 1 through 6, and Endpoint (Alprazolam Free [AF] Week 6)|ITT; subject has a baseline and at least 1 post-baseline measurement before week 13; endpoint = AF Week 6 or LOCF; (n) = number of subjects with data for analysis for pregabalin and placebo, respectively.||scores on scale||Standard Error|Least Squares Mean
728621|NCT00368745|Primary|Number of Subjects at Endpoint (Post Alprazolam Free Week 6 or Last Observation Carried Forward [LOCF] Post Alprazolam Free Week 1) Who Are Benzodiazepine Free|Number of subjects benzodiazepine free: < 2 doses rescue medication; negative urine benzodiazepine psychoactive toxicology assay (each visit Alprazolam Free phase); negative serum benzodiazepine alcohol assay (endpoint or LOCF).|Endpoint (Post Alprazolam Free Week 6 or LOCF Post Alprazolam Free Week 1)|Intent to Treat (ITT) population: received at least 1 dose pregabalin or placebo. Primary outcome ITT = all treated subjects in alprazolam free phase. Endpoint = Post Alprazolam Free Week 6 or LOCF Post Alprazolam Free Week 1.||participants|||Number
728622|NCT00368849|Secondary|Unified Huntington Disease Rating Scale (UHDRS) Total Motor Score|Although changes in motor symptoms were not hypothesized, the Unified Huntington Disease Rating Scale motor examination was administered at every visit. An experienced motor rater completes a motor examination and rates the participant on several motor tasks. Total score ranges from 0 - 124, with higher scores indicating a worse outcome. The outcome reported was change in score from baseline for each treatment arm.|There are two time points for this measure: baseline and after 4 weeks of treatment|Analysis was based on number of completers.||units on a scale||Standard Error|Mean
728637|NCT00368940|Primary|Montgomery Asberg Depression Scale (MADRS)|Montgomery Asberg Depression Scale (MADRS) is a depression rating scale. Range of scores (1-35). Higher scores represent worse outcome (depression).|12 week outcome|||Units on MADRS scale||Standard Error|Least Squares Mean
728623|NCT00368849|Secondary|Symptom Checklist-90-Revised (SCL-90-R)|Psychiatric symptoms were evaluated with the Symptom Checklist-90-Revised, a self report measure of psychiatric symptoms. The measure produces raw scores and normed scores (T scores Mean = 50), with higher values representing greater impairment. The outcome reported was change in score from baseline for each treatment arm.|There are two time points for this measure: baseline and after 4 weeks of treatment|Analysis was based on number of completers.||units on a scale||Standard Error|Mean
728624|NCT00368849|Primary|Executive Composite Score|The executive composite comprises performance on Trail Making Test Part B, Stroop Color and Word Test, and the Controlled Oral Word Association Test (i.e., Verbal Fluency). The composite score is the average combined z score for each test. Positive values indicate better than average performance and negative values worse than average. The outcome reported was change in score from baseline for each treatment arm.|There are two time points for this measure: baseline and after 4 weeks of treatment|Analysis was based on number of completers.||units on a scale||Standard Error|Mean
728625|NCT00368849|Primary|Attention Composite Score|The attention composite comprises performance on Wechsler Adult Intelligence Scale III Symbol-Digit and Letter Number Sequencing Subtests, Trail Making Test Part A, computerized simple-choice reaction time, and computerized working memory (i.e., 2-Back). The composite score is the average combined z score for each test. Higher, positive values indicate better than average performance and negative and lower values indicate worse than average. The outcome reported was change in score from baseline for each treatment arm.|There are two time points for this measure: baseline and after 4 weeks of treatment|Analysis was based on number of completers.||Units on a scale||Standard Error|Mean
728626|NCT00368849|Primary|Conners' Adult Attention Rating Scale (CAARS)|The Conners' Adult Attention Rating Scale (CAARS) is one of the most frequently used self-rating measures for adult Attention Deficit Hyperactivity Disorder (ADHD) and was given as a self-report measure of attention. It has 66 items with each item ranging from 0 to 3 points. Higher total scores represent greater impairment. The outcome reported was change in score from baseline for each treatment arm.|There are two time points for this measure: baseline and after 4 weeks of treatment|Analysis was based on number of completers||units on a scale||Standard Error|Mean
728627|NCT00368875|Secondary|Overall Survival(OS)|Assessed by Kaplan-Meier survival analysis and 95% confidence intervals will be calculated using Greenwood’s formulae.|Time from first treatment day until death, assessed up to 12 months|54 patients in the phase I and phase II portion were evaluated||months||95% Confidence Interval|Median
728628|NCT00368875|Secondary|Time to Treatment Failure (TTF)|Assessed by Kaplan-Meier survival analysis and 95% confidence intervals will be calculated using Greenwood’s formulae. Time to treatment failure was not reported for this study.|Time from the first treatment day until disease progression or discontinuation of treatment due to toxicity, assessed up to 12 months|Zero participants analyzed because time to treatment failure was not assessed.|||||
728629|NCT00368875|Secondary|Progression-free Survival (PFS),|Assessed by Kaplan-Meier survival analysis and 95% confidence intervals will be calculated using Greenwood’s formulae.|From first treatment day until objective or symptomatic progression, assessed up to 12 months|53 patients in the phase I and phase II portions were evaluated||months||95% Confidence Interval|Median
728630|NCT00368875|Primary|Objective Response Rate (CR + PR)|Estimated and a 95% confidence interval will be estimated via binomial proportions. Per Response Evaluation Criteria in Solid Tumors (RECIST) for target lesions and assessed by CT scan: Complete response (CR): Disappearance of all target lesions; Partial Response (PR): >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR+PR.|Up to 12 months|53 patients in the phase I and phase II portions were evaluated. One patient was not eligible to be evaluated for objective response rate.||percentage of participants||95% Confidence Interval|Number
728631|NCT00368875|Primary|Recommended Phase II Dose as Assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (Phase I)|Dose-limiting toxcities (DLT) were defined as grade 3-4 febrile neutropenia, thrombocytopenia and non-hemtological toxicity attributed to therapy (nausea, vomiting and diarrhea would be considered dose limiting only if not adequately controlled with therapy). Any toxicity occurring during cycle 1 that resulted in dose reduction of vorinostat or paclitaxel or failure to complete all protocol specificed doses in the first cycle was also considered a DLT|28 days|Three patients were treated at the first vorinostat dose level of 200 mg BID and three additional patients were treated at the second dose level of 300 mg BID||mg|||Number
728632|NCT00368927|Secondary|Percent Change in Number of Dysplastic Lesions (DL) as Measured by Mucosal Biopsy Samples Before and After the Intervention|The number of dysplastic lesions was recorded pre-intervention and post-intervention for each participant in each group. Change in the number of lesions was compared between the two intervention groups.|Baseline and 6 months|The population used for the analysis is patients completing both the pre- and post- intervention bronchoscopy.||Percent change in number of DL||Full Range|Median
728633|NCT00368927|Primary|Percentage of Participants With Response Determined by Change in Histologic Grade of Bronchial Dysplasia as Measured by Mucosal Biopsy Samples Before and After Treatment|Definition of response: complete response = regression of all dysplastic lesions (DL) to normal, hyperplasia or metaplasia with no new DL identified; partial response = regression of one or more, but not all of the DL with no new DL identified and no lesions worsening; progression = worsening at one or more sites by at least 2 histologic grades or appearance of any new DL that were not previously biopsied; stable disease = participants not classified as having a complete response, partial response, or progressive disease|Baseline and 6 months|The population used for the analysis is patients completing both the pre- and post-intervention bronchoscopy.||percentage of participants|||Number
728634|NCT00368940|Secondary|Sheehan Disability Scale.|Sheehan Disability Scale is a measure of disability. Range of scores: 0-20. Higher scores reflect worse outcome (disability).|Outcome at 12 weeks|||units on a scale||Standard Deviation|Mean
728635|NCT00368940|Secondary|Hamilton Depression Rating Scale|Hamilton Depression Rating Scale is a scale measuring depression severity. Range of scores: 1-33. Higher scores reflect worse outcome (depression).|Outcome at 12 weeks|||units on a scale||Standard Deviation|Mean
728636|NCT00368940|Primary|WHO Disability Assessment Schedule (WHODAS)-II|WHO Disability Assessment Schedule (WHODAS)-II is a disability scale. Range of scores: 12-43. Higher scores represent worse outcome (disability).|12-week outcome|||WHODAS-II units||Standard Error|Least Squares Mean
728638|NCT00368966|Primary|Percentage of Participants Achieving Antibody Level ≥ 0.35 Microgram Per Milliliter (μg/mL) in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose|Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥ 0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes, present in both 13vPnC and 7vPnC (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)|The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.||Percentage of Participants||95% Confidence Interval|Number
728639|NCT00368966|Primary|Geometric Mean Antibody Concentrations (GMC) for Pertussis in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose|GMCs with the corresponding 95% CI for each concomitant antigen pertussis antigens (PT, FHA, PRN, and FIM) as measured by EU/mL are presented.|One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age)|The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.||EU/mL||95% Confidence Interval|Geometric Mean
728640|NCT00368966|Primary|Geometric Mean Antibody Concentrations (GMC) for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose||One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age)|The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.||IU/mL||95% Confidence Interval|Geometric Mean
728641|NCT00368966|Primary|Geometric Mean Titers (GMT) for Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose||One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age)|The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.||titer||95% Confidence Interval|Geometric Mean
728642|NCT00368966|Primary|Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose|Percentage of participants achieving predefined antibody threshold levels with the corresponding 95% CI for each concomitant antigen (pertussis antigens including Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), and Pertactin (PRN); diphtheria; tetanus; and poliovirus types 1, 2, and 3) are presented.|One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age)|The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.||percentage of participants||95% Confidence Interval|Number
728643|NCT00368966|Primary|Geometric Mean Antibody Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose|GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes which are present in both 7vPnC and 13vPnC (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)|The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate IgG antibody concentration to the given serotype.||μg/mL||95% Confidence Interval|Geometric Mean
728644|NCT00368966|Primary|Percentage of Participants Reporting Pre-Specified Systemic Events|Systemic events (fever [Fv] ≥ 37.5 degrees Celsius [C], fever ≥ 38 C but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased [Decr] appetite, irritability, increased [Incr] sleep, decreased sleep, hives, use of medication [Med] to treat symptoms [sx], and use of medication to prevent symptoms) were reported using an electronic diary. Participants may be represented in more than 1 category.|During the 4-day period after each dose|The safety population included all subjects who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.||percentage of participants|||Number
728645|NCT00368966|Primary|Percentage of Participants Reporting Pre-Specified Local Reactions|Local reactions were collected using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (Sig) (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (Mod) (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.|During the 4-day period after each dose|The safety population included all participants who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.||percentage of participants|||Number
728646|NCT00368966|Primary|Geometric Mean Antibody Concentration (GMC) for Diphtheria in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series||One month after 2-doses of the infant series (5 months of age)|The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.||IU/mL||95% Confidence Interval|Geometric Mean
728647|NCT00368966|Primary|Geometric Mean Titer (GMT) of Meningococcal C in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series||One month after 2-doses of the infant series (5 months of age)|The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.||titer||95% Confidence Interval|Geometric Mean
729760|NCT00383110|Secondary|Systolic Blood Pressure||12-months after enrollment|Discrepancies in number of participants analyzed is due to some participants having no data in their medical record for this measure.||mmHg||Standard Deviation|Mean
728648|NCT00368966|Primary|Percentage of Participants Achieving Predefined Meningococcal C Serum Bactericidal Assay (SBA) Titer of ≥ 1:8, and a Predefined Antibody Level for Diphtheria in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series|Percentage of participants achieving predefined antibody threshold levels; greater than or equal to (≥) 1:8 for meningococcal C SBA titer and ≥ 0.10 or >=0.01 International Units Per Milliliter (IU/mL) for diphtheria along with the corresponding 95% Confidence Interval (CI) are presented.|One month after 2-doses of the infant series (5 months of age)|Evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.||Percentage of Participants||95% Confidence Interval|Number
728649|NCT00368979|Secondary|Number of Participants With Qmax Improvement From Baseline at Week 52|Improvement was defined as an increase in Qmax by greater than or equal to 1 mL/sec|Baseline and Week 52|The Full Analysis Set (FAS) which consisted of all randomized participants with a history excluding those who received no dose of the investigational product and who had no baseline or post baseline IPSS data. Last Observation Carried Forward (LOCF) method for lost data.||participants|||Number
728650|NCT00368979|Secondary|Change From Baseline in Maximum Urine Flow Rate (Qmax) at Week 52|Maximum Urine Flow Rate (Qmax) is the peak flow in milliliters per second.|Baseline and Week 52|The Full Analysis Set (FAS) which consisted of all randomized participants with a history excluding those who received no dose of the investigational product and who had no baseline or post baseline IPSS data. Last Observation Carried Forward (LOCF) method for lost data.||milliliters per second (mL/sec)||Standard Deviation|Mean
728651|NCT00368979|Secondary|Number of Participants With IPSS Improvement From Baseline at Week 52|Improvement is defined as greater than or equal to a 2 point increase in participants total score on the I-PSS questionaire.|Baseline and Week 52|The Full Analysis Set (FAS) which consisted of all randomized participants with a history excluding those who received no dose of the investigational product and who had no baseline or post baseline IPSS data. Last Observation Carried Forward (LOCF) method for lost data.||participants|||Number
728652|NCT00368979|Secondary|Percent Change From Baseline in Prostate Volume at Week 52|Prostate volume measurements by transrectal ultrasound (TRUS). Average prostate volume (55cc). The Ultrasound scans the prostate in the transverse plane while moving in the cephalocaudal direction of the prostate. The height and width of the prostate section with the greatest surface area is recorded.|Baseline and Week 52|The Full Analysis Set (FAS) which consisted of all randomized participants with a history excluding those who received no dose of the investigational product and who had no baseline or post baseline IPSS data. Last Observation Carried Forward (LOCF) method for lost data.||cubic centimeters (cc)||Standard Deviation|Mean
728653|NCT00368979|Primary|Change From Baseline in International Prostate Symptom Score (IPSS) at Week 52|The International Prostate Symptom Score (I-PSS) consists of 7 verified questions concerning urinary symptoms and one quality of life question scored from 0 to 5(0=Not at All, to 5=Almost Always). The total score can range from 0 to 35. Score of 1-7=Mild, 8-19=Moderate, 20-35=Severe.|Baseline and Week 52|The Full Analysis Set (FAS) which consisted of all randomized participants with a history excluding those who received no dose of the investigational product and who had no baseline or post baseline IPSS data. Last Observation Carried Forward (LOCF) method for lost data.||score on a scale||Standard Deviation|Mean
728654|NCT00368992|Secondary|Response Rate|Confirmed and unconfirmed complete and partial responses per RECIST in the subset of patients with at least one target lesion assessed by CT or MRI. A complete response (CR) was defined as disappearance of all disease, including non-target lesions. A partial response (PR) was defined as a >= 30% decrease in the sum of the longest diameters of all target lesions. A CR or PR was confirmed if documented a second time at least 4 weeks after the first documentation.|Every 6 weeks while on protocol treatment, up to 3 years.|Eligible patients who received protocol treatment and who had measurable disease (as defined by RECIST) at baseline were included in the analysis.||percentage of participants||95% Confidence Interval|Number
728655|NCT00368992|Secondary|Overall Survival|From date of enrollment to date of death due to any cause. Patients last known to be alive were censored at date of last contact.|Once a week, up to 3 years.|Eligible patients who received protocol treatment were included in the analysis.||months||95% Confidence Interval|Median
728656|NCT00368992|Secondary|Progression-Free Survival|From data of registration to date of disease progression (as defined by RECIST, i.e. a 20% increase in the sum of the longest diameters of target lesions, or unequivocal progression ina non-target lesion in the opinion of the treating investigator, or the appearance of new lesions), symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free were censored at the date of last contact.|Every 6 weeks until disease progression. After 9 months, every 12 weeks until disease progression, up to 3 years.|Eligible patients who received protocol treatment were included in the analysis.||Months||95% Confidence Interval|Median
728657|NCT00368992|Primary|The Percentage of Patients With Grade 4 (i.e. Life-threatening) Hemorrhage Toxicities Related to Protocol Treatment.|All patients who received protocol treatment were assessed for adverse events per the NCI Common Terminology Criteria for Adverse Events, Version 3.0. We counted the number of patients who reported at least one Grade 4 (i.e. life-threatening) hemorrhage adverse event that was possibly, probably, or definitely related to the study treatment.|Every week until removed from protocol therapy, up to 3 years.|Eligible patients who received protocol treatment were included in the analysis.||percentage of participants||95% Confidence Interval|Number
728658|NCT00369122|Secondary|Overall Survival (Failure: Death Due to Any Cause)|Estimated using the Kaplan-Meier method.|From registration to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for two years.||||||
728659|NCT00369122|Secondary|Disease-free Survival (Failure: Local, Regional or Distant Failure, or Death Due to Any Cause)|Estimated using the Kaplan-Meier method.|From registration to date of failure (any tumor recurrence, development of distant metastases, or death) or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years.||||||
728660|NCT00369122|Secondary|Treatment-related SAEs and AEs as Assessed by CTCAE v. 3.0 Criteria at Any Time.||From start of treatment to end of follow-up||||||
728675|NCT00369278|Secondary|Time to “Event” for the Composite Endpoint as Well as All Individual Components of That Endpoint “Treatment Failure” Including Clinical Rejections|Due to a small number of events, median time to <event> was not reached.|6 months||||||
728661|NCT00369122|Primary|Subjects With Treatment-related Serious Adverse Events (SAEs) and Adverse Events (AEs) as Assessed by CTCAE v. 3.0 Criteria Within the First 90 Days From Treatment Start.|Treatment-related SAEs defined as Grade (Gr) >= 4 vaginal bleeding, Gr >=4 thrombotic event, Gr >=3 arterial event, gastrointestinal (GI) bleeding , or bowel/bladder perforation, and any Gr 5 treatment-related AE. Treatment-related AEs defined as all SAEs, Gr 3-4 nausea, vomiting, or diarrhea persisting for >2 weeks depsite medical intervention, Gr 4 neutropenia or leukopenia persisiting for >7 days, febrile neutropenia defined as a temperature >38.5 degree Celsius and granulocytes < 1000/mm3, Grade 3-4 hematologic toxicity with the exception of neutropenia and leukopenia, and Grade 3-4 GI, renal, cardiac, pulmonary, hepatic, or neurologic AEs. Based on a report by Laciano, et al. an SAE rate of 5% and AE rate of 35% were considered tolerable and an SAE rate >=20% and AE rate >=55% excessive. If there were >=6 pts with SAES or >=22 pts with AEs then the treatment would be rejected. This study design provides alpha of 0.05 and power of 90%.|From start of treatment to 90 days.|Eligible patients who began study treatment.||participants|||Number
728662|NCT00369161|Secondary|Percentage of Participants With Efficacy Failure|Efficacy failure was a composite of BPAR, graft loss, death or lost to follow-up. BPAR was defined as a clinically suspected acute rejection confirmed by biopsy (performed by the local pathologist). For all clinically suspected rejection episodes a graft core biopsy must have been performed before or within a 24 hour period from the initiation of anti-rejection therapy. An allograft was presumed to be lost on the day a patient started dialysis and was unable to subsequently be removed from dialysis. If the patient underwent a graft nephrectomy, the day of nephrectomy was the day of graft loss.|Month 12|Intention to treat (ITT) population.||percentage of participants|||Number
728663|NCT00369161|Secondary|Number of Participants With Incidence of Biopsy-proven Acute Rejection (BPAR)|Biopsy-proven acute rejection (BPAR) was defined as a clinically suspected acute rejection confirmed by biopsy (performed by the local pathologist). For all clinically suspected rejection episodes a graft core biopsy must have been performed before or within a 24 hour period from the initiation of anti-rejection therapy.|from Month 4 through to Month 12|Intention to treat (ITT) population.||participants|||Number
728664|NCT00369161|Primary|Renal Function Assessed by Calculated Glomerular Filtration Rate (cGFR)|"Renal function was assessed by calculated glomerular filtration rate (cGFR) using Modification of Diet in Renal Disease (MDRD)formula.
GFR [mL/min/1.73m^2] = 186.3*(C-1.154)*(A-0.203)*G*R, where:
C is the serum concentration of creatinine [mg/dL],
A is patient age at sample collection date [years],
G=0.742 when gender is female, otherwise G=1,
R=1.21 when race is black, otherwise R=1"|12 months post -transplant|Modified Intent-to-treat (ITT) population i.e patients with an available cGFR at month 12.||mL/min/1.73m^2||Standard Deviation|Mean
728665|NCT00369226|Secondary|Overall Survival and Progression-free Survival.|Progression is defined as disease relapse or disease progression since transplant.|by 1 year after PBSC infusion|||percentage of participants||95% Confidence Interval|Number
728666|NCT00369226|Secondary|Incidence of Chronic Graft Versus Host Disease (Chronic GVHD).|Number of participants with chronic GVHD at 1 year post transplant.|by 1 year after PBSC infusion|||percentage of participants||95% Confidence Interval|Number
728667|NCT00369226|Secondary|Sustained Engraftment Following Transplant.|As measured by median total donor chimerism at day 100.|by day 100 post transplant|Several subjects experienced failure to graft, relapse or death prior to assessment and were removed from analysis.||percentage of participants|||Number
728668|NCT00369226|Primary|Incidence of Grade II-IV Acute Graft Versus Host Disease (GVHD) by Day 100.||by day 100 after peripheral blood stem cell (PBSC) infusion|||percentage of participants||95% Confidence Interval|Number
728669|NCT00369226|Primary|Successful Initial Engraftment by Day 45 Post Peripheral Blood Stem Cell (PBSC) Infusion and Administration of Bortezomib (Velcade), Tacrolimus and Methotrexate|Percentage of participants who did not experience failure to engraft or relapse or death before assessment.|by day 45 post PBSC infusion|||percentage of participants|||Number
728670|NCT00369226|Primary|The Maximally Tolerated Dose (MTD) of Bortezomib (Velcade) That Can be Administered With Tacrolimus and Methotrexate After Mismatched Allogeneic Non-myeloablative Peripheral Blood Stem Cell (PBSC) Transplantation|"The MTD of bortezomib was evaluated at 3 dose levels:
Dose level 1: 1.0 mg/m^2 Dose level 2: 1.3 mg/m^2 Dose level 3: 1.5 mg/m^2 Cohorts of 3-5 pts were enrolled at each dose level. At any dose level, if no DLT in the first 3, 4, or 5 pts, then dose escalation would occur.
If 3 evaluable pts in cohort, and 1 of 3 experiences DLT then 2 additional pts treated at the same dose level. If >=1 of 2 additional pts experience DLT then previous dose level will be MTD. If no DLT in additional 2 pts then dose escalation will occur. If 4 evaluable pts in cohort, and 1 of the 4 experiences DLT then 1 additional pt treated at same dose level. If this additional pt experiences DLT then the previous dose will be declared to be the MTD. If additional pt does not experience DLT, then dose escalation will take place. If 5 evaluable pts in cohort, and 1 experiences DLT, then dose escalation will take place. If >=2 of first 3, 4, or 5 pts experience DLT then the previous dose will be declared MTD."|by day 45 post PBSC infusion|||mg/m^2|||Number
728671|NCT00369265|Primary|Percentage of Participants With Improvement or Resolution of Arytenoid Erythema|Improvement was measured by score on an arytenoid erythema grading scale assigned by member of research staff and independent observers at 6 weeks|6 weeks|No results to report; Study was terminated|||||
728672|NCT00369278|Secondary|Renal Function as Measured by Glomerular Filtration Rate (GFR)|"The Glomerular Filtration Rate (GFR) was calculated using the following formulas:
Cockcroft-Gault formula: calculation using the participant's age, gender, weight, and serum creatinine levels.
MDRD formula: calculation using the participant's age, gender, serum creatinine, urea nitrogen, and albumin levels."|6 months|Intent-to-treat population for whom data was available. End of Study data was imputed using Last Observation Carried Forward (LOCF).||ml/min||Standard Deviation|Mean
728673|NCT00369278|Primary|Number of Participants With Any Treatment Failure|Treatment failures were defined as a composite endpoint of biopsy proven acute rejection (BPAR), graft loss, and death, loss to follow up and discontinuations from study drug treatment due to lack of efficacy or toxicity (at least one condition must be present) during the first 6 months or until final assessment. Any participants who were suspected of having acute rejection episodes had biopsies performed to prove whether a rejection had occurred. Graft loss was considered as the day the patient started dialysis and was not able to subsequently be removed or the day of graft nephrectomy.|6 months|||Participants|||Number
728674|NCT00369278|Secondary|Renal Function as Measured by Serum Creatinine||6 months|||mg/dL||Standard Deviation|Mean
728677|NCT00369278|Secondary|Number of Participants With Single Treatment Failures|"Rates for all individual components of the primary endpoint ‘treatment failure’ until day 180:
Acute rejection diagnosed by biopsy (BPAR)
graft loss
death
loss to follow up
discontinuation from study drug due to lack of efficacy or toxicity (adverse events, every adverse event had to be interpreted as toxicity)
conversion to another dosing regimen (conversion to tacrolimus, prograf, etc.)"|6 months|Intent-to-treat population||Participants|||Number
728678|NCT00369278|Primary|Time to First Occurrence of Any Treatment Failure During the First 6 Months Post-treatment or at Month 6 Post-treatment|Median time to first occurrence of treatment failure was not reached in this study.|6 months||||||
728679|NCT00369278|Primary|Time to First Occurrence of a Mycophenolic Acid (MPA) Plasma Concentration of ≥ 40 mg*h/L|Non-compartmental MPA pharmacokinetic parameters were derived from individual plasma concentration-time profiles using WinNonLin 5.2 software. The areas under the curve were calculated by means of the linear trapezoidal rule.|Assessed on day 3, 10, 21, 42, 56 and 84|Pharmacokinetic profiles were performed only in patients involved in Phase I of the study. The pharmacokinetic population consisted of 42 participants.||Days||95% Confidence Interval|Median
728680|NCT00374803|Secondary|GI Toxicities|Hospitalizations due to Gastrointestinal (GI) toxicities of mycophenolic acid enteric coated (Myfortic)|12 months|||participants|||Number
728681|NCT00374803|Secondary|Incidence of Post Transplant Infections|Incidence of post transplant infections that resulted in hospitalization|12 months|||participants|||Number
728682|NCT00374803|Secondary|Renal Function at 12 Months|Renal function measured by serum creatinine (SCr) at 12 months post-transplant|12 months|||mg/dL||Standard Deviation|Mean
728683|NCT00374803|Secondary|Patient and Allograft Survival 12 Months|Patient and allograft survival at 12 months post-transplant. Allograft survival is different from rejection. An allograft can have rejection, but the allograft can still have survival. If an allograft fails and is no longer functioning this would be considered allograft failure and non-survival.|12 months|||participants|||Number
728684|NCT00374803|Primary|Incidence of All Biopsy Proven Acute Rejection.|Treatment efficacy, defined as the incidence of all biopsy proven acute rejection. Biopsy was proven with tissue samples collected on patients with elevated serum creatinine|12 months|||Participants|||Number
728685|NCT00374842|Secondary|Number of Subjects With Any and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE = any occurrence of an SAE, regardless of relationship to study vaccination. A related SAE = an SAE assessed by the investigator as causally related to the study vaccination.|From study start to study end, from Day 0 to Day 30|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subject|||Number
728686|NCT00374842|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. Any AE = any occurrence of an AE, regardless of intensity or relationship to study vaccination. Grade 3 = an event that prevented normal activity. Related = event assessed by the investigator as causally related to the study vaccination.|Within the 30-day follow-up period (Days 0-29) after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subject|||Number
728687|NCT00374842|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, fever (axillary temperature higher than or equal to (>=) 37.5 degrees Celsius (°C)), headache, muscle aches, and shivering. Any = Occurrence of a particular symptom regardless of intensity or relationship to vaccination. Grade 3 symptom = Symptom which prevented normal activity. Related = Symptom assessed by the investigator as causally related to the study vaccination. Grade 3 fever = axillary temperature higher than 39.0°C.|Within the 7-day follow-up period (Days 0-6) after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subject|||Number
728688|NCT00374842|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were ecchymosis, pain, redness and swelling the site of injection. Any = occurrence of a solicited local symptom regardless of intensity grade. Grade 3 pain = Pain which prevented normal activity. Grade 3 ecchymosis/redness/swelling = ecchymosis/redness/swelling at injection site with a diameter larger than (>) 50 millimeters (mm). All solicited local symptoms assessed were considered by the investigator as causally related to the study vaccination.|Within the 7-day follow-up period (Days 0-6) after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subject|||Number
728689|NCT00374842|Primary|Seroconversion Factor Against Each of the 3 Influenza Strains Assessed.|Influenza strains assessed were the A/New Caledonia (A/CAL), A/Wisconsin (A/WIS), and B/Malaysia (B/MAL) strains. The seroconversion factor (SCF) was defined as a ratio, as the fold increase in serum haemagglutination-inhibition geometric mean titers (GMTs) post-vaccination compared to Day 0 (with GMTs in the above calculation expressed in haemagglutination-inhibition units (HIU) [e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenza antigen]).|At Day 21.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.||Fold increase||95% Confidence Interval|Geometric Mean
728690|NCT00374842|Primary|Number of Seroconverted Subjects Against Each of the 3 Influenza Strains Assessed|Influenza strains assessed were the A/New Caledonia (A/CAL), A/Wisconsin (A/WIS), and B/Malaysia (B/MAL) strains. A seroconverted subject was a subject who had either a pre-vaccination serum HI antibody titer lower than 10 haemagglutination-inhibition units (HIU) (e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenzae antigen) and a post-vaccination titer higher than or equal to 40 HIU, or a pre-vaccination titer >= 10 and at least a four-fold increase in post- vaccination titer.|At Day 21.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.||Subject|||Number
728691|NCT00374842|Primary|Number of Seroprotected Subjects Against Each of the 3 Influenza Strains Assessed.|A seroprotected subject was a subject whose antibody titer against each of the influenza strains assessed (A/New Caledonia (A/CAL), A/Wisconsin (A/WIS) and B/Malaysia (B/MAL) strains) was equal to or higher than (>=) the assay seroprotection cut-off value of 40 haemagglutination-inhibition units (HIU) (e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenzae antigen).|At Day 0 and at Day 21.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.||Subject|||Number
728692|NCT00374842|Primary|Titers of Serum Haemagglutination-inhibition (HI) Antibodies Against Each of the 3 Influenza Strains Assessed.|Influenza strains assessed were the A/New Caledonia (A/CAL), A/Wisconsin (A/WIS), B/Malaysia (B/MAL) strains. Titers were presented as geometric mean titers (GMTs) calculated on subjects with available results, and expressed in haemagglutination-inhibition unit (HIU), e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenzae antigen. The seropositivity cut-off value of the assay was 10 HIU.|At Day 0 and at Day 21.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.||HIU||95% Confidence Interval|Geometric Mean
728693|NCT00374868|Secondary|Overall Survival|Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.|baseline to date of death from any cause (up to 620 days)|20 patients were censored.||days||Standard Error|Mean
728694|NCT00374868|Secondary|Progression-Free Survival|Defined as the time from study enrollment until disease progression or death from any cause.|baseline to measured progressive disease (up to 620 days)|11 patients were censored||days||95% Confidence Interval|Median
728695|NCT00374868|Secondary|Time to Treatment Failure (TTF)|Time from study enrollment to first observation of disease progression, death from any cause, or early discontinuation of treatment (including toxicity or if patient had stable disease after 4 cycles). TTF was censored at date of last follow-up visit for patients who did not discontinue early, who were still alive, and who had not progressed.|baseline to stopping treatment (up to 620 days)|1 patient was censored||days||95% Confidence Interval|Median
728696|NCT00374868|Secondary|Time to Progressive Disease|Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause. Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions.|baseline to measured progressive disease (up to 620 days)|19 patients were censored||days||Standard Error|Mean
728697|NCT00374868|Secondary|Duration of Stable Disease|Defined as time from study enrollment to the first progression of disease, complete response, partial response, or death from any cause. Complete response (CR) = disappearance of all target lesions. Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions. Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions. Stable disease (SD) = small changes that do not meet above criteria.|time of no response or progression (up to 620 days)|1 patient was censored.||days||95% Confidence Interval|Median
728698|NCT00374868|Secondary|Duration of Response|The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. Complete response (CR) = disappearance of all target lesions. Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions.|time of response to progressive disease (up to 620 days)|10 patients were censored.||days||Standard Error|Mean
728699|NCT00374868|Secondary|Time to Response|Defined as time from study enrollment to the first Complete Response or Partial Response (using RECIST criteria). Complete response (CR) = disappearance of all target lesions. Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions.|baseline to response (up to 620 days)|16 patients were censored.||days||Standard Error|Mean
728700|NCT00374868|Primary|Best Overall Tumor Response|"Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve (respond), stay the same (stable), or worsen (progression) during treatment. Complete response (CR) = disappearance of all target lesions. Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions. Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions. Stable disease (SD) = small changes that do not meet above criteria."|baseline to measured progressive disease (up to 620 days)|||participants|||Number
728738|NCT00384241|Primary|Change in Urinary Sodium Excretion (UNaV)|The value of Stress induced UNaV as determined by delta UNaV = stress UNaV - baseline UNaV.|Baseline and 4 hour|All 500 subjects in the group Children were analyzed. This data was not intended to be analyzed for Arm 2 Parents.||pg/ml||Standard Deviation|Mean
728739|NCT00384293|Secondary|Change in Lipid Profile||after 96 weeks of postrandomization treatment|study prematurely terminated, no efficacy analyses were performed|||||
728705|NCT00380588|Other Pre-specified|Survival Time|Data of patients lost to follow-up were censored at the last date of confirmation of their survival.|baseline to date of death due to any cause (up to 2 years)|||months||95% Confidence Interval|Median
728706|NCT00380588|Secondary|Progression Free Survival|The period from study entry until disease progression, death or date of last contact.|baseline to measured progressive disease (up to 2 years)|Number of patients who received at least one dose of study drug.||months||95% Confidence Interval|Median
728707|NCT00380588|Secondary|Tumor Response|"Response Evaluation Criteria In Solid Tumors - define when cancer patients improve (respond), stay the same (stabilize), or worsen (progression) during treatments. Complete response (CR) = disappearance of all target lesions; Partial Response (PR) = 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) = 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD) = small changes that do not meet above criteria."|baseline to measured progressive disease (up to 2 years)|Number of patients who received at least one dose of study drug.||participants|||Number
728708|NCT00380588|Primary|Percentage of Patients Alive at 1 Year (1-Year Survival Rate)|Percentage of patients alive at 1 year.|1 year|Number of patients who received at least one dose of study drug.||percentage of participants|||Number
728709|NCT00380692|Secondary|Cytochrome P450 2D6 Genotype|Genotype characterization was used to determine participants' metabolic status.|baseline|All randomized participants.||participants|||Number
728710|NCT00380692|Secondary|Amsterdam Neuropsychological Tasks (ANT): Flanker Interference Task - Reaction Times|Task is the same as described in Outcome Measure #19. Mean reaction times (RTs) are computed for correct responses to compatible and incompatible flankers, respectively.|Baseline, 8 weeks|Number of participants with baseline and non-missing postbaseline value at visit.||milliseconds||Standard Deviation|Mean
728711|NCT00380692|Secondary|Amsterdam Neuropsychological Tasks (ANT): Flanker Interference Task - Error Rates|Measures ability to neglect stimuli interfering with predefined stimulus-response coupling. Child presented with displays of 9 colored squares. Child responds to color of central square by pressing left mouse key when blue, and right mouse key when yellow. Part 1 (40 trials), surrounding squares may be same color (compatible) or different (neutral). Part 2 (80 trials), in 50% of trials, surrounding squares have color corresponding to predefined key press for other hand (incompatible). Error rates are percentages of errors in response to compatible and incompatible signals, respectively.|Baseline, 8 weeks|Number of participants with baseline and one non-missing postbaseline value at visit.||error rate (percentages)||Standard Deviation|Mean
728712|NCT00380692|Secondary|Amsterdam Neuropsychological Tasks (ANT): Go/No-Go Response Inhibition Task - Error Rates|Measures inhibition of pre-potent responses. 24 Go signals (open squares) are presented, randomly mixed with 24 No-Go signals (closed squares). Subjects are required to press a key if a Go signal (target) appears on the screen but to withhold a response if they see a No-Go signal. Error rate is the percentage of key presses to No-Go signals/total number of trials X 100.|Baseline, 8 weeks|Number of participants with baseline and a non-missing postbaseline value at visit.||error rate (percentage)||Standard Deviation|Mean
728713|NCT00380692|Secondary|Amsterdam Neuropsychological Tasks (ANT): Pursuit Motor Control Task - Stability of Movement|A complex visuo-motor flexibility task that measures eye-hand co-ordination and fine motor control. By moving mouse cursor, the child is required to follow as closely as possible a target that randomly moves across the PC-screen. Stability is within subject variability of mean distance between cursor and target.|Baseline, 8 weeks|Number of participants with baseline and non-missing postbaseline value at visit.||millimeters||Standard Deviation|Mean
728714|NCT00380692|Secondary|Amsterdam Neuropsychological Tasks (ANT): Pursuit Motor Control Task - Accuracy|A complex visuo-motor flexibility task that aims at measuring eye-hand co-ordination and fine motor control. By moving mouse cursor, the child is required to follow as closely as possible a target that randomly moves across the PC-screen. Accuracy is the mean distance between the mouse cursor and the moving target.|Baseline, 8 weeks|Number of participants with baseline and non-missing postbaseline value at visit.||millimeters||Standard Deviation|Mean
728715|NCT00380692|Secondary|Amsterdam Neuropsychological Tasks (ANT): Memory Search Task - Standard Deviation (SD) of Reaction Times for Hits and Correct Rejections|Task is the same as described in Outcome Measure #14. Standard deviations of reaction times (RT) assess intraindividual variability in RT referring to the two conditions creating hits and correct rejections as mentioned in Outcome Measure #14.|Baseline, 8 weeks|Number of participants with baseline and a non-missing postbaseline value at visit.||milliseconds||Standard Deviation|Mean
728740|NCT00384293|Primary|Change in Mean Carotid Intima Media Thickness|change in mean carotid intima media thickness defined as a composite measure of the left and right common, bulb, and internal carotid artery.|after 96 weeks of postrandomization treatment|study prematurely terminated, no efficacy analyses were performed|||||
728716|NCT00380692|Secondary|Amsterdam Neuropsychological Tasks (ANT): Memory Search Task - Reaction Times for Hits and Correct Rejections|Memory search task aims at measuring serial search processes to be carried out in working memory. There are 2 blocks (loads) with 40 trials each. Load 1 has 1 target to remember (one animal). A “yes” is required whenever the target is part of displayed set of 4 animals. Load 2 has 2 animals. A “yes” is required whenever one of the animals appears in successively displayed sets of 4 animals. Targets are present in 50% of the trials. Reaction time (RT) for hits is mean RT of correct “yes” responses to targets. RT correct rejections are mean RTs of correct “no” responses when target was missing.|Baseline, 8 Weeks|Number of participants with baseline and a non-missing postbaseline value at visit.||milliseconds||Standard Deviation|Mean
728717|NCT00380692|Secondary|Amsterdam Neuropsychological Tasks (ANT): Memory Search Task - Error Rates|The memory search task aims at measuring serial search processes to be carried out in working memory. There are 2 blocks (loads) with 40 trials each. Load 1 has 1 target to identify (e.g., an animal). A “yes” is required whenever the target is part of the displayed set of four stimuli (all animals). Load 2 has 2 targets. Whenever 1 of the targets appears in the successively displayed sets of four animals, a “yes” is required. Targets are present in 50% of trials. Error rates are the percentages of errors made in each task condition, based on the number of errors/total number of trials X 100.|Baseline, 8 Weeks|Number of participants with baseline and a non-missing postbaseline value at visit.||error rate (percentage)||Standard Deviation|Mean
728718|NCT00380692|Secondary|Amsterdam Neuropsychological Tasks (ANT): Focused Attention Task - Standard Deviation of Reaction Times for Hits and Correct Rejections|Task is the same as described in Outcome Measure #10. Standard deviations of reaction times (RT) assess intraindividual variability in RT and refer to the same conditions as those for mean reaction times described in Outcome Measure #11.|Baseline, 8 Weeks|Number of participants with baseline and a non-missing postbaseline value at visit.||milliseconds||Standard Deviation|Mean
728719|NCT00380692|Secondary|Amsterdam Neuropsychological Tasks (ANT): Focused Attention Task - Reaction Times for Hits and Correct Rejections|Task is the same as described in Outcome Measure #10. Reaction times (RT) for hits are mean RTs of correct responses to relevant targets. RTs for correct rejections are mean RTs for correct rejections are mean RTs for correct no responses to irrelevant targets and relevant nontargets.|Baseline, 8 Weeks|Number of participants with baseline and a non-missing postbaseline value at visit.||milliseconds||Standard Deviation|Mean
728720|NCT00380692|Secondary|Amsterdam Neuropsychological Tasks (ANT): Focused Attention Task - Error Rates|Focused attention assessed distractibility. Child needs to identify a specific target (eg, Cherry); non-target is any other fruit. Child presses “yes” when target occurs in relevant position (eg, one of vertical positions on diamond). Child presses “no” when target is absent, or when target appears on horizontal position (irrelevant target). Error rates are percentage of missing relevant targets and percentage of false alarms in response to (irr)relevant (non)targets based on number of errors/total number of trials X 100.|Baseline, 8 Weeks|Number of participants with baseline and a non-missing postbaseline value at visit.||error rate (percentage)||Standard Deviation|Mean
728721|NCT00380692|Secondary|Nijmeegse Ouderlijke Stress Index (NOSI) Total Score|The NOSI contains 123 items to be completed by the primary caregiver. Individual item scores range from 1 (completely agree) to 6 (completely disagree). Total scores range from 123 to 738.|Baseline, 8 weeks, 28 weeks|Randomized participants with value at timepoint.||units on a scale||Standard Deviation|Mean
728722|NCT00380692|Secondary|General Health Questionnaire (GHQ) Total Score|Parental distress is measured with the GHQ. The raw total score (based on 0-0-1-1 scoring system) can be used as an overall index of psychological distress, ranging from 0 to 12 with higher scores indicating more distress.|Baseline, 8 weeks, 28 weeks|Randomized participants with value at timepoint.||units on a scale||Standard Deviation|Mean
728723|NCT00380692|Secondary|Children's Social Behavior Questionnaire (CSBQ) Total Score|CSBQ is filled out by parents and consists of 49 items. Items are rated in an ordinal rather than a discrete fashion in order to establish the extent to which problems are present. The CSBQ consists of six subscales. Individual item scores range from 0=does not apply to 2=applies clearly. Total score ranges from 0 to 98.|Baseline, 8 weeks, 28 weeks|Randomized participants with value at timepoint.||units on a scale||Standard Deviation|Mean
728724|NCT00380692|Secondary|Aberrant Behavior Checklist (ABC)|The ABC is a 58-item informant-based scale comprised of five subscales (Irritability [15 items], Lethargy [16], Stereotypic Behaviors [7], Hyperactivity [16], Inappropriate Speech [4]). Individual item scores range from 0 (no problem) to 3 (severe problem). Subscale scores are total of individual item scores in subscale: Irritability (0-45); Lethargy (0-48); Stereotypic (0-21); Hyperactivity (0-48); Inappropriate Speech (0-12).|Baseline, 8 weeks, 28 weeks|Randomized participants with values at timepoint.||units on a scale||Standard Deviation|Mean
728725|NCT00380692|Secondary|Sleep Measure Scale|10-item parent-based scale assessing sleep problems (6 point Likert scale). Scores: Difficulty falling asleep (1-6); Quality of sleep (3-18); Functional outcome (6-36). Lower scores indicate higher problems with item. Open-ended items: Time to fall asleep (1 [0-15 minutes] to 5 [>1 hour]); Total hours (numbers associated with hours of sleep).|Baseline, 8 weeks, 28 weeks|Randomized participants with a value at timepoint.||units on a scale||Standard Deviation|Mean
728726|NCT00380692|Secondary|ADHD Rating Scale-IV-Parent Version: Investigator Scored Total Score|Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54.|28 weeks|Randomized participants with a value at timepoint.||units on a scale||Standard Deviation|Mean
728727|NCT00380692|Secondary|Conners' Teacher Rating Scale - Revised: Short Form (CTRS-R:S)|A 28-item rating scale (0 [not at all/never] to 3 [very much true/very often]) completed by the teacher to assess problem behaviors related to ADHD. Subscale total scores range from 0 to 15 for Oppositional and Cognitive Problems, 0 to 21 for Hyperactivity, and 0 to 36 for ADHD Index.|Baseline, 8 weeks, 28 weeks|Number of randomized participants who had a value at timepoint.||units on a scale||Standard Deviation|Mean
728728|NCT00380692|Secondary|Clinical Global Impressions-ADHD-Improvement (CGI-ADHD - I)|Measures total improvement (or worsening) of a patient's ADHD symptoms from the beginning of treatment (1=very much improved, 7=very much worsened).|8 weeks, 28 weeks|Number of randomized participants with values at timepoint.||units on a scale||Standard Deviation|Mean
728760|NCT00384865|Secondary|Adverse Events|Please refer to the Adverse Event Tables for specific information|Measured at 6 months|||events|||Number
728729|NCT00380692|Primary|ADHD Rating Scale-IV-Parent Version: Investigator Scored - Total Score|Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders, Version IV (DSM-IV) diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54.|Baseline and 8 weeks|Number of randomized participants with a value at baseline and 8 week endpoint. Last Observation Carried Forward analysis.||units on a scale||Standard Deviation|Mean
728730|NCT00380718|Secondary|Time to Tumor Progression|Time to documented tumor progression was defined as the time from the date of enrollment to the first date of documented disease progression. Time to documented disease progression was censored at the date of death for participants who had not had documented disease progression. Otherwise, the censoring rules were the same as for Progression-Free Survival.|baseline to measured progressive disease (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until documented disease progression, or up to 18 months after enrollment)|Number of participants who received at least one dose of study drug. Sixteen participants were censored as they were alive at the time of analysis.||months||95% Confidence Interval|Median
728731|NCT00380718|Secondary|Time to Treatment Failure|Time to treatment failure was define as the time from the date of enrollment to the date of the first of the following events: objective disease progression, death due to any cause, treatment discontinuation for undocumented progression, early treatment discontinuation for toxicity or other reason, or new anticancer treatment started. Time to treatment failure for participants who were still participating in the study without treatment failure at the time of analysis were treated as censored at the date of the last tumor assessment.|baseline to early treatment discontinuation or measured progressive disease or death from any cause (assessments every 2 cycles during therapy and 6-8 weeks during post-therapy until documented disease progression, or up to 18 months after enrollment)|Number of participants who received at least one dose of study drug. One patient was censored as he/she was alive at time of analysis.||months||95% Confidence Interval|Median
728732|NCT00380718|Secondary|Duration of Response|Duration of overall tumor response was measured from the time of first documentation of complete response or partial response (whichever status was first recorded) until the date of progression-free survival, with censoring defined as: disease had not progressed, treatment was discontinued due to undocumented progression or toxicity/other reason, onset of new anti-tumor therapy or otherwise experienced death/progression after more than one missed (assessment) visit.|time of response to measured progressive disease or death from any cause (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until documented disease progression, or up to 18 months after enrollment)|Participants who received study drug and who had either a complete or partial response to treatment. Three participants were censored as they were alive at the time of analysis.||months||Full Range|Median
728733|NCT00380718|Secondary|Progression-Free Survival (PFS)|Time to PFS was defined as the time from the date of enrollment to the date of the first of the following events: objective disease progression or death due to any cause. Survival time frame includes post-treatment follow-up of up to 18 months post-Last Patient Entered Treatment. Patients were censored if their disease had not progressed, treatment was discontinued due to an undocumented progression or toxicity/other reason, onset of new anti-tumor therapy or otherwise experienced death/progression after more than one missed (assessment) visit.|baseline to measured progressive disease or death from any cause (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until documented disease progression, or up to 18 months after enrollment)|Number of participants who received at least one dose of study drug. Sixteen participants were censored as they were alive at the time of analysis.||months||95% Confidence Interval|Median
728734|NCT00380718|Secondary|Overall Survival|Overall survival is the duration from enrollment to death from any cause. For patients who are alive, overall survival is censored at the last follow-up visit.|baseline to date of death from any cause (includes post-treatment follow-up of up to 18 months post-Last Patient Entered Treatment)|Number of participants who received at least one dose of study drug. Sixteen participants were censored as they were alive at the time of analysis.||months||Full Range|Median
728735|NCT00380718|Secondary|Proportion of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), and Stable Disease (SD) (Disease Control Rate [DCR])|DCR was defined as the proportion of best overall response of CR, PR, and SD. DCR=(CR+PR+SD)/Number of participants. Response was evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.|baseline to measured progressive disease (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until documented disease progression, or up to 18 months after enrollment)|"Number of participants who received at least one dose of study drug. Participants who were classified as Unknown were considered nonresponders rather than missing."||proportion of participants||95% Confidence Interval|Mean
728736|NCT00380718|Primary|Proportion of Participants With a Complete or Partial Response (Objective Response Rate [ORR])|"The objective response rate (ORR) was defined as the proportion of participants who achieved a best response of either complete response (CR) or partial response (PR) (responders) based on the RECIST criteria. ORR=(CR+PR)/Number of Participants. The RECIST define when cancer patients improve (respond), stay the same (stabilize), or worsen (progression) during treatments."|baseline to measured progressive disease (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until documented disease progression, or up to 18 months after enrollment)|"Number of participants who received at least one dose of study drug. Participants who were classified as Unknown were considered nonresponders rather than missing."||proportion of responders||95% Confidence Interval|Mean
728737|NCT00384241|Secondary|The Effect of Change in Stress Induced IL-6 on Systolic Blood Pressure|Stress induced systolic blood pressure (SBP) data generated from two previous studies was collected. In the previous studies, systolic blood pressures were measured before and after completing a video game challenge. Stress induced SBP is defined as delta SBP = stress SBP - baseline SBP.|baseline and 4 hours|All 500 subjects in the group Children were analyzed. This data was not intended to be analyzed for Arm 2 Parents.||mmHg||Standard Deviation|Mean
728774|NCT00384956|Post-Hoc|Duration of Response (DOR)||2 years after first dose of study drug or until participant is lost to follow-up or dies|||days||Full Range|Median
728741|NCT00384332|Secondary|Change From Baseline Montgomery Asberg Depression Rating Scale|Montgomery Asberg Depression Rating Scale (MADRS) total score. Construct: Depression severity. Scores below represent mean change scores, endpoint minus baseline. Minimum total score: 0 (no depression). Maximum total score: 60 (severe depression). Lower (more negative) scores indicate a better outcome. There are no subscales.|10 weeks|Patients with bipolar disorder randomized to orally disintegrating versus regular olanzapine.||units on a scale||Standard Deviation|Mean
728742|NCT00384332|Primary|Weight in Kilograms at Baseline, Weeks 1, 4, 6, and 8|Change in weight from baseline to endpoint in kilograms. Reported as weight in Kilograms at Baseline, Weeks 1, 4, 6, and 8|10 weeks|||kilograms||Standard Error|Mean
728743|NCT00384397|Secondary|Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination|Injection site reactions: tenderness, erythema, and swelling at the Menactra site (Visits 1 and 2) and the measles-mumps-rubella, varicella (MMRV) and pneumococcal conjugate vaccine (PCV) sites (only Visit 2); Systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, and irritability following each vaccination.|0-7 days post-vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.||Percentage of Participants|||Number
728744|NCT00384397|Other Pre-specified|Meningococcal Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titers Following Visit 2 Vaccination(s) at 12 Months.||30 days post-Visit 2 Menactra®|Geometric mean titers and their 95% Confidence Intervals, measured by SBA-HC, were assessed in the per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
728745|NCT00384397|Other Pre-specified|Percentage of Participants With Antibody Titers ≥ 4 After Visit 2 Menactra® Vaccination as Measured by Serum Bactericidal Assay Using Human Complement (SBA-HC)||30 days post-Visit 2 Menactra®|Antibody titers were assessed in the per-protocol population.||Percentage of Participants|||Number
728746|NCT00384397|Primary|Percentage of Participants With Antibody Titers ≥ 8 After Visit 2 Menactra® Vaccination as Measured by Serum Bactericidal Assay Using Human Complement (SBA-HC)||30 days post-visit 2 Menactra®|Antibody titers were assessed in the per-protocol population.||Percentage of Participants|||Number
728747|NCT00384670|Secondary|Number of Solicited Symptoms 7 Days (0-6) After Second Dose of Japanese Encephalitis (JE) Vaccine.|Number of solicited general symptoms within the 7-day follow-up after the second dose of Japanese encephalitis (JE) vaccine doses (total vaccinated cohort)|Approximately Day 225 and Day 255|||Number of solicited general symptoms|||Number
728748|NCT00384670|Secondary|Number of Solicited Symptoms 7 Days (0-6) After First Dose of Japanese Encephalitis (JE) Vaccine.|Number of solicited general symptoms within the 7-day follow-up after the first dose of Japanese encephalitis (JE) vaccine doses (total vaccinated cohort)|Approximately Day 225 and Day 255|||adverse events|||Number
728749|NCT00384670|Secondary|Neutralizing Antibody (GMT) to JE and 4 Dengue Types, 30 Days After the Second Dose of JE Vaccine.|Geometric mean titers (GMT) for neutralizing (N) Ig to DEN-1, N Ig to DEN-2, N Ig to DEN-3, N Ig to DEN-4, and N Ig to JE vaccine antibody titers.|Approximately Day 225 and Day 255|1 subjects experience an asymptomatic, sub-clinical, DEN-2 virus infection prior to dengue vaccine dose 1 and was eliminated from the according to protocol (ATP) analysis of immunogenicity.||titer||95% Confidence Interval|Geometric Mean
728750|NCT00384670|Secondary|Percentage of Individuals With Neutralizing Antibody (Seroconversion) to Japanese Encephalitis (JE) and 4 Dengue Types, 30 Days After the Second Dose of JE Vaccine.|Percentage of individuals with ≥ 10 dilution (DIL) for neutralizing (N) Ig to DEN-1, N Ig to DEN-2, N Ig to DEN-3, N Ig to DEN-4, and N Ig to Japanese encephalitis (JE) vaccine antibody titers.|30 days after the second dose of JE vaccine|1 subjects experience an asymptomatic, sub-clinical, DEN-2 virus infection prior to dengue vaccine dose 1 and was eliminated from the according to protocol (ATP) analysis of immunogenicity.||percentage of participants||95% Confidence Interval|Number
728751|NCT00384670|Secondary|Number of Solicited Adverse Events for 21 Days (0-20) After the Second Dose of Dengue Vaccine|Number of solicited general symptoms within the 21-day follow-up of dengue dose 2 vaccine dose (total vaccinated cohort)|21 Days (0-20) After the Second Dose of Dengue Vaccine|||adverse events|||Number
728752|NCT00384670|Secondary|Number of Unsolicited Adverse Events Within 30 Days After Each Dose of Dengue Vaccine|Number of subjects with unsolicited symptoms classified by MedDRA Primary System Organ Class and Preferred Term, within 30 days after dengue vaccine (total vaccinated cohort)|30 days|||adverse events|||Number
728753|NCT00384670|Primary|Number of Solicited Adverse Events Within 21 Days After the First Dose of Dengue Vaccine.|Number of solicited general symptoms within the 21-day follow-up after dengue dose 1 (total vaccinated cohort).|21 days|||adverse events|||Number
728754|NCT00384748|Primary|Physical Function as Measured by Telephone Version of FIM|The FONEFIM was developed as a telephonic alternative and yields good concordance to the in-person, performance based FIM.12 The motor subscale of the FONEFIM (Motor FONEFIM) consists of 13 items encompassing four categories: 1) self-care; 2) sphincter control; 3) transfers; and 4) locomotion. Each item is scored on an ordinal scale from 1= total dependence to 7 = total independence. Possible scores range from 13 to 91, with higher scores indicating greater independence. The scoring considers the use of adaptive equipment and/or the extent of personal assistance or supervision required to complete the task.|6-month|||units on a scale||Standard Deviation|Mean
728755|NCT00384813|Secondary|Brief Symptom Inventory (BSI)||4 months, 10 months||||||
728756|NCT00384813|Secondary|Parenting Stress Index - SF (PSI-SF)||4 months, 10 months||||||
728757|NCT00384813|Primary|Asthma Morbidity, as Determined by Number of Asthma Symptom Days, Number of School Days Missed Due to Asthma, and Number of Emergency Department Visits for Acute Asthma||4 months, 10 months||||||
728758|NCT00384813|Primary|Metered Dose Inhaler Checklist (MDIC)|Observational rating scale assessing MDI/spacer technique|4 months, 10 months||||||
728759|NCT00384813|Primary|Mean Score on the Family Asthma Management System Scale (FAMSS)|Family Asthma Management System Scale is semi-structured clinical interview that includes open-ended questions assessing family management of pediatric asthma. The interview is recorded and rated using a standard manual on seven core subscales and two optional subscales.The interview is recorded and rated on seven to nine 9-point subscales that tap the various domains of asthma management, with higher scores indicating better management (1 being the worse asthma management and 9 being the best asthma management). Mean of all of the subscales used to compute a total score.|4 months from baseline|||units on a scale||Standard Error|Mean
728761|NCT00384865|Secondary|Time to Clinical Worsening Events (Number of Events)|Defined by the addition of new PAH therapies or dose increases in previously stable PAH therapy, hospitalization for right-sided heart failure, lung transplantation, atrial septostomy, and cardiovascular and all-cause death.|Measured at 6 months|||events|||Number
728762|NCT00384865|Primary|Distance Walked in Six Minutes||Measured at 6 months|||meters||95% Confidence Interval|Least Squares Mean
728763|NCT00384930|Primary|Change From Baseline to Week 12 in International Prostate Symptom Score (IPSS): Supportive Analysis|Assesses the severity of BPH-LUTS and the response to therapy. The total score was derived by summing the scores of the responses to the 7 component questions. Scores range from 0 to 35; 0-7 Mildly symptomatic; 8-19 moderately symptomatic; 20-35 severely symptomatic.|Baseline and 12 weeks|Primary analysis was performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
728764|NCT00384930|Secondary|Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF) EF Domain|Measures erectile function over the past 4 weeks on Questions 1-5 and 15 (6 questions) of the International Index of Erecile Function (IIEF) questionnaire. Scores range from 0 (low/no erectile function) to 5 (high erectile function), thus the 6 questions of the IIEF-EF domain range from 0 to 30.|baseline and 12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from all randomized and sexually active subjects with a history of ED and non-missing data at baseline and at least one postbaseline visit were used for the analysis. Last observation carried forward.||units on a scale||Standard Deviation|Mean
728765|NCT00384930|Secondary|Change From Baseline to 12 Week Endpoint in Peak Urinary Flow|Measures the maximum flow rate of urine (measured in mL/s). This is a continuous parameter with positive numeric values.|baseline and 12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward.||milliliter per second||Standard Deviation|Mean
728766|NCT00384930|Secondary|"Number of Participants Who Answer Yes to the Lower Urinary Tract Symptoms (LUTS) Global Assessment Question (LUTS-GAQ)"|LUTS-GAQ Question asks the participant if the treatment they have been on has improved their uninary symptoms.|12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward.||participants|||Number
728767|NCT00384930|Secondary|Change From Baseline to 12 Week Endpoint in Benign Prostatic Hyperplasia Impact Index (BII)|Measures the impact that symptoms of BPH has on the patients well being. This questionnaire has 4 questions assessing the level of urinary discomfort and it's impact on the patients. Three questions range from 0 (no impact) to 4 (high impact); one question ranges from 0 (low impact) to 4 (high impact). The BII score ranges from 0 to 16.|baseline and 12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward.||units on a scale||Standard Deviation|Mean
728768|NCT00384930|Secondary|Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Quality of Life (QoL) Index|Assessment of quality of life (QOL) by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible).|baseline and 12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward.||units on a scale||Standard Deviation|Mean
728769|NCT00384930|Secondary|Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Question 7 (Nocturia)|Measures nocturia (the need to get up at night to urinate) over the past 4 weeks. Scores range from 1 (few episodes of nocturia) to 5 (frequent episodes of nocturia).|baseline and 12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward.||units on a scale||Standard Deviation|Mean
728770|NCT00384930|Secondary|Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore|Measures obstructive symptoms over the past 4 weeks of the IPSS. IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 1 (few obstructive symptoms) to 5 (frequent obstructive symptoms), thus the 4 questions of the obstructive score range from 0 to 20.|12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward.||units on a scale||Standard Deviation|Mean
728771|NCT00384930|Secondary|Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) (Irritative) Subscore|Measures irritative symptoms over the past 4 weeks of the IPSS. IPSS irritative subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. Scores range from 1 (few irritative symptoms) to 5 (frequent irritative symptoms), thus the 3 questions of the irritative subscore range from 0 to 15.|baseline and 12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward.||units on a scale||Standard Deviation|Mean
728772|NCT00384930|Primary|Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS): Primary Analysis|Assesses the severity of BPH-LUTS and the response to therapy. The total score was derived by summing the scores of the responses to the 7 component questions. Scores range from 0 to 35; 0-7 Mildly symptomatic; 8-19 moderately symptomatic; 20-35 severely symptomatic.|Baseline and 12 weeks|Primary analysis was performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward.||units on a scale||Standard Deviation|Mean
728773|NCT00384956|Post-Hoc|Progression-free Survival (PFS)|"PFS is defined as the interval from the date of first dose of study drug to date of treatment failure, recurrence, or death due to any cause.
Disease progression
for patients w/ <5% blasts; a ≥50% increase in blasts to >5% blasts
for patients w/ 5% to 10% blasts; a ≥50 increase to >10% blasts
for patients w/ 10% to 20% blasts; a ≥50% increase to >20% blasts
for patients w/ 20% to 30% blasts; a ≥50% increase to >30% blasts
One or more of the following ≥50% decrement from maximum remission/response levels in granulocytes or platelets, reduction in hemoglobin concentration by ≥2 g/dL or transfusion dependence"|2 years after first dose of study drug or until participant is lost to follow-up or dies|||days||Full Range|Median
728776|NCT00384956|Secondary|Rate of Overall Survival|Overall survival is defined as the date of first dose of study drug to the date of death from any cause.|2 years after first dose of study drug or until participant is lost to follow-up or dies|||days||Full Range|Median
728777|NCT00384956|Secondary|Rate of Cytogenetic Response||2 years after first dose of study drug or until participant is lost to follow-up or dies|This secondary outcome was not analyzed.|||||
728778|NCT00384956|Post-Hoc|Time to Best Response||4 weeks following last dose of azacitidine [median number of cycles 4.5 (1-20)]|||days||Full Range|Median
728779|NCT00384956|Secondary|Rate of Transfusion Independence||4 weeks following last azacitidine dose [median number of cycles 4.5 (1-20)]|Only participants with baseline transfusion dependence were assessed for this outcome measure.||participants|||Number
728780|NCT00384956|Secondary|Rate of Hematologic Improvement|International Working Group (IWG) for Myelodysplasia (MDS).|4 weeks following last azacitidine dose [median number of cycles 4.5 (1-20)]|||participants|||Number
728781|NCT00384956|Primary|Rate of Complete Remission (CR) and Partial Remission (PR)|"Defined according to the modified International Working Group (IWG) (2006) response criteria for myelodysplasia:
CR=bone marrow with <5% myeloblasts and 0% peripheral blasts, hemoglobin ≥11g/dL, platelets ≥ 100 x 10^9/L, and neutrophils ≥1.0 x 10^9/L. Residual dysplasia was allowed.
PR= All of the CR criteria if abnormal before treatment except: bone marrow blasts decreased by ≥50% over pretreatment but still >5%."|After 4 cycles of therapy (up to 112 days after start of treatment)|||participants|||Number
728782|NCT00385138|Secondary|Incidence of Stroke|mITT population|randomization through 30 days post randomization|mITT population, based on available data||participants|||Number
728783|NCT00385138|Secondary|Incidence of Stent Thrombosis|mITT population|randomization through 30 days post randomization|mITT population, based on available data||participants|||Number
728784|NCT00385138|Secondary|Incidence of IDR|mITT population|randomization through 30 days post randomization|mITT population, based on available data||participants|||Number
728785|NCT00385138|Secondary|Incidence of MI|mITT population|randomization through 30 days post randomization|mITT population, based on available data||participants|||Number
728786|NCT00385138|Secondary|Incidence of All-cause Mortality|mITT population|randomization through 30 days post randomization|mITT population, based on available data||participants|||Number
728787|NCT00385138|Secondary|Incidence of All-cause Mortality or MI|mITT population|randomization through 30 days post randomization|mITT population, based on available data||participants|||Number
728788|NCT00385138|Secondary|Incidence of All-cause Mortality, MI, or IDR|mITT population|randomization through 30 days post randomization|mITT population, based on available data||participants|||Number
728789|NCT00385138|Secondary|Incidence of ACUITY Major Bleeding Without Hematoma >/= 5 cm|Major bleeding (non-CABG-related) - Safety population excludes ACUITY major bleeding for which the only qualifying event was hematoma >/= 5 cm.|randomization through 48 hours post randomization|Safety population||participants|||Number
728790|NCT00385138|Secondary|Incidence of ACUITY Major Bleeding|Major bleeding (non-CABG-related) - Safety population|randomization through 48 hours post randomization|Safety population||participants|||Number
728791|NCT00385138|Secondary|Incidence of Thrombolysis in Myocardial Infarction (TIMI) Major|Major bleeding (non-CABG-related) - Safety population|randomization through 48 hours post randomization|Safety population||participants|||Number
728792|NCT00385138|Secondary|Incidence of GUSTO Severe / Life-threatening|Major bleeding (non-CABG-related) - Safety population|randomization through 48 hours post randomization|Safety population||participants|||Number
728793|NCT00385138|Secondary|Incidence of Procedure Events [Abrupt Closure, Threatened Abrupt Closure, Need for Urgent Coronary Artery Bypass Graft (CABG) Surgery, Unsuccessful Procedure, New Thrombus or Suspected Thrombus, and/or Acute Stent Thrombosis]|mITT population A patient could have multiple procedural events.|During index PCI|mITT population, based on available data||participants|||Number
728794|NCT00385138|Secondary|Incidence of All-cause Mortality|mITT population|randomization through 1 year post randomization|mITT population, based on available data||participants|||Number
728795|NCT00385138|Secondary|Incidence of Stroke|mITT|randomization through 48 hours post randomization|mITT population, based on available data||participants|||Number
728796|NCT00385138|Secondary|Incidence of Stent Thrombosis|mITT population|randomization through 48 hours post randomization|mITT population, based on available data||participants|||Number
728797|NCT00385138|Secondary|Incidence of IDR|mITT population|randomization through 48 hours post randomization|mITT population, based on available data||participants|||Number
728798|NCT00385138|Secondary|Incidence of MI|mITT population|randomization through 48 hours post randomization|mITT population, based on available data||participants|||Number
728799|NCT00385138|Secondary|Incidence of All-cause Mortality|mITT population|randomization through 48 hours post randomization|mITT population, based on available data||participants|||Number
728800|NCT00385138|Secondary|Incidence of All-cause Mortality or MI|mITT population|randomization through 48 hours post randomization|mITT population, based on available data||participants|||Number
728801|NCT00385138|Primary|Incidence of All-cause Mortality, Myocardial Infarction (MI), and Ischemia-driven Revascularization (IDR)|mITT population; (composite incidence)|randomization through 48 hours post randomization|mITT population, based on available data||participants|||Number
728802|NCT00385203|Secondary|Anti-tumour Activity as Measured by Total Lesion Volume at Week 16 in GIST Patients by Central Review of CT Images.|Central review of CT images taking the total lesion volume at week 16 minus the total lesion volume at baseline.|CT assessments at Baseline and Week 16|As per the protocol formal statistical analysis was performed for the GIST group only, STS patients were summarised. For patients to be included in the analysis they had to have CT scans at both timepoints (baseline and week 8).||cm3||95% Confidence Interval|Mean
728803|NCT00385203|Secondary|Tumour Activity as Measured by Total Lesion Volume at Week 8 in GIST Patients by Central Review of CT Images.|Central review of CT images taking the total lesion volume at week 8 minus the total lesion volume at baseline.|CT assessments at Baseline and Week 8|As per the protocol formal statistical analysis was performed for the GIST group only, STS patients were summarised. For patients to be included in the analysis they had to have CT scans at both timepoints (baseline and week 8).||cm3||95% Confidence Interval|Mean
728804|NCT00385203|Secondary|Anti-tumour Activity as Measured by Major Axis (Axial Plane) at Week 16 in GIST/STS Patients by Central Review of CT Images.|Central review of CT images taking the longest diameter measured in millimetres at week 16 [major axis (axial plane)] minus the longest diameter measured in millimetres at baseline.|CT assessments at Baseline and Week 16.|As per the protocol formal statistical analysis was performed for the GIST group only, STS patients were summarised. For patients to be included in the analysis they had to have CT scans at both timepoints (baseline and week 8).||mm||95% Confidence Interval|Mean
728805|NCT00385203|Secondary|-Tumour Activity as Measured by Major Axis (Axial Plane) at Week 8 in GIST/STS Patients by Central Review of CT Images.|Central review of CT images taking the longest diameter measured in millimetres at week 8 [major axis (axial plane)] minus the longest diameter measured in millimetres at baseline.|CT assessments at Baseline and Week 8|As per the protocol the formal statistical analysis was performed for the GIST grouppatients only, STS patients were summarised (not STS patients). For patients to be included in the analysis they had to have CT scans at both timepoints (baseline and week 8).||mm||95% Confidence Interval|Mean
728806|NCT00385203|Secondary|Objective Tumour Response, Investigator Review|Number of patients with complete (CR) /partial response (PR) (based on RECIST) as assessed by the Investigator. CR is defined as Disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of Longest Diameter (LD) of target lesions taking as reference the baseline sum LD.|RECIST at Baseline, Weeks 8, 16 and every 12 weeks thereafter until progression.|||Participants|||Number
728807|NCT00385203|Primary|Tumour Metabolic Activity as Assessed by Change in Central Review of Standardised Uptake Value (SUVMax) at Day 29, in Patients With GIST Tumours. SUVmax at Day 29 Minus SUVmax at Baseline.|SUVmax at Day 29 minus SUVmax at baseline, based on central review, GIST patients|FDG-PET assessment at Baseline and 29 days after dosing.|As per the protocol the analysis was for GIST patients only (not STS patients). For patients to be included in the analysis they had to have scans with readable results at both timepoints (baseline and Day 29).||g/mL||95% Confidence Interval|Mean
728808|NCT00385203|Primary|Change in Standardised Uptake Value (SUV)Max at Day 8, Central Review, (GIST) Gastrointestinal Stromal Tumours Patients.|[F 18] Fluoro 2 Deoxy D Glucose - Positron Emission Tomography (FDG-PET). Tumour metabolic activity as assessed by Change in Standardised Uptake Value (SUVMax) at Day 8 (measured by central review), in Patients with GIST tumours. SUVmax at Day 8 minus SUVmax at Baseline.|Baseline and 8 days after dosing.|As per the protocol the analysis was for GIST patients only (not STS patients). For patients to be included in the analysis they had to have scans with readable results at both timepoints (baseline and Day 8).||g/mL||95% Confidence Interval|Mean
728809|NCT00385216|Secondary|Diastolic Blood Pressure|Diastolic blood pressure reported in Millimeters of Mercury (mmHg)|5 days|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
728810|NCT00385216|Secondary|Systolic Blood Pressure|Systolic blood pressure reported in Millimeters of Mercury (mmHg)|5 days|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
728811|NCT00385216|Secondary|Heart Rate|Heart rate reported in beats per minute (BPM)|5 days|||Beats per minute (BPM)||Standard Deviation|Mean
728812|NCT00385216|Secondary|hydrocodone5 mg/Acetaminopgen 325 mg Use||5 days||||||
728813|NCT00385216|Secondary|Nausea||5 days||||||
728814|NCT00385216|Primary|Pain Reported by Patient|Pain reported on the numerical rating scale for pain (NRS) with 0=no pain and 10=worst pain.|1 day|||Numeric Rating Scale (NRS)||Standard Deviation|Mean
728815|NCT00385268|Primary|Urine Benzoylecgonine Tests (UBT)|The primary outcome measure for this trial was qualitative urine benzoylecgonine tests (UBT) obtained twice weekly. Urine collection was monitored by temperature checks. Samples less than 90 degrees, or greater than 100 degrees Fahrenheit were considered invalid and were not accepted. Samples were analyzed for benzoylecgonine by fluorescent polarization assay. Samples containing equal to or greater than 300 ng/ml of benzoylecgonine were considered to be positive.|8 weeks|||% of negative UBT|||Number
728816|NCT00385268|Primary|Cocaine Use as Measured by Self Report on the Time-Line Follow Back and Confirmed With Urine Drug Screen.||8 weeks||||||
728817|NCT00385515|Secondary|Number of Participants With Ulcerative Oral Mucositis|All randomized subjects were directly observed by trained evaluators for at least 10 consecutive days during the chemotherapy cycle to identify recurrence of ulcerative oral mucositis.|At least 10 consecutive days beginning on Day 1 of a chemotherapy cycle|||Participants|||Number
728818|NCT00385515|Primary|Duration of Ulcerative Oral Mucositis|All randomized subjects were directly observed by trained evaluators for at least 10 consecutive days during the chemotherapy cycle to document the duration for those that developed recurrent ulcerative oral mucositis|At least 10 consecutive days beginning on Day 1 of a chemotherapy cycle|Analysis only includes subjects randomized to the 30mg dose of SNX-1012||Days||Standard Deviation|Mean
728819|NCT00385541|Secondary|Mean Score on the Ramsey Scale of Sedation|The Ramsey scale is used as a measure of sedation from 1 (the patient in anxious and agitated) to 6 (the patient exhibits no response).|1 hour after surgery, 8 hours after surgery|||score on scale||Standard Deviation|Mean
728820|NCT00385541|Secondary|The Number of Patients Who Vomited||1 hour after surgery, 8 hours after surgery|||participants|||Number
728821|NCT00385541|Secondary|Pain Assessment by Patient|Numeric Rating Scale for Pain: (0 = none, 10 = the worst), ordinal.|1 hour after surgery, 8 hours after surgery|||Units on a scale||Standard Deviation|Mean
728822|NCT00385541|Secondary|Mean Score on the Numeric Rating Scare (NRS) Pruritus Scale|The NRS Pruritus Scale was used to measure magnitude of pruritus (0 = none, 10 = the worst).|1 hour after surgery, 8 hours after surgery|||Units on a scale||Standard Deviation|Mean
728823|NCT00385541|Primary|Nausea Assessment by Patient|Nausea scale range: (0 = none, 10 = the worst), ordinal.|1 hour after surgery, 8 hours after surgery|Intention to treat (ITT)||Units on a scale||Standard Deviation|Mean
728824|NCT00385580|Secondary|Mean Plasma Concentration at Dose 50 mg (Week 6)|Mean plasma concentration was obtained directly from the concentration-time data.|At pre-dose, 1 hour, 3 hours, 6 hours and at 12 hours after any dose for BID and QD group.|All available concentration-time data from participants who received at least 1 dose of dasatinib. The 'n' is signifying those who were evaluated for this measure at timepoint for each group respectively. Data are split by actual dose administered. If there was dose modification, participant was grouped according to dose given on PK collection day.||ng/mL||Standard Deviation|Mean
728825|NCT00385580|Secondary|Mean Plasma Concentration at 50 mg Dasatinib Dose (Week 2)|Mean plasma concentration was obtained directly from the concentration-time data.|At pre-dose, 1 hour, 3 hours, 6 hours and at 12 hours after any dose for BID and QD group.|All available concentration-time data from participants who received at least 1 dose of dasatinib. The 'n' is signifying those who were evaluated for this measure at timepoint for each group respectively. Data are split by actual dose administered. If there was dose modification, participant was grouped according to dose given on PK collection day.||ng/mL||Standard Deviation|Mean
728826|NCT00385580|Secondary|Mean Plasma Concentration at 70 mg Dasatinib Dose (Week 6)|Mean plasma concentration was obtained directly from the concentration-time data.|At pre-dose, 1 hour, 3 hours, 6 hours and at 12 hours after any dose for BID group.|All available concentration-time data from participants who received at least 1 dose of dasatinib. The 'n' is signifying those who were evaluated for this measure at timepoint for each group respectively. Data are split by actual dose administered. In treatment group (100 mg, QD), no participant received a 70 mg at PK collection day.||ng/mL||Standard Deviation|Mean
728827|NCT00385580|Secondary|Mean Plasma Concentration at 70 mg Dasatinib Dose (Week 2)|Mean plasma concentration was obtained directly from the concentration-time data.|At pre-dose, 1 hour, 3 hours, 6 hours and at 12 hours after any dose for BID and QD group.|All available concentration-time data from participants who received at least 1 dose of dasatinib. The 'n' is signifying those who were evaluated for this measure at timepoint for each group respectively. Data are split by actual dose administered. If there was dose modification, participant was grouped according to dose given on PK collection day.||ng/mL||Standard Deviation|Mean
728828|NCT00385580|Secondary|Mean Plasma Concentration at 100 mg Dasatinib Dose (Week 6)|Mean plasma concentration was obtained directly from the concentration-time data.|At pre-dose, 1 hour, 3 hours, 6 hours and at 12 hours after any dose for BID and QD group.|All available concentration-time data from participants who received at least 1 dose of dasatinib. The 'n' is signifying those who were evaluated for this measure at timepoint for each group respectively. Data are split by actual dose administered. If there was dose modification, participant was grouped according to dose given on PK collection day.||ng/mL||Standard Deviation|Mean
728829|NCT00385580|Secondary|Mean Plasma Concentration at 100 mg Dasatinib Dose (Week 2)|Mean plasma concentration was obtained directly from the concentration-time data.|At pre-dose, 1 hour, 3 hours, 6 hours and at 12 hours after any dose for BID and QD group.|All available concentration-time data from participants who received at least 1 dose of dasatinib. The 'n' is signifying those who were evaluated for this measure at timepoint for each group respectively. Data are split by actual dose administered. If there was dose modification, participant was grouped according to dose given on PK collection day.||ng/mL||Standard Deviation|Mean
728830|NCT00385580|Secondary|Median Number of Months of BAP Response|The median number of months of the BAP response was calculated for participants with baseline BAP <= ULN, from first dose of dasatinib to the first time BAP is above ULN. For participants with baseline BAP > ULN, it was the time from BAP response to the first time BAP was above ULN. For participants with baseline BAP =< ULN or BAP, and no BAP above ULN, last BAP assessment date was used. The median number of months of response was not defined for participants with baseline value > ULN, that never achieved BAP response.|Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.|Participants who demonstrated a BAP response||months||95% Confidence Interval|Median
728831|NCT00385580|Secondary|Number of Participants With BAP Response|BAP is a measure of bone metabolism. A BAP response is calculated for participants with a baseline BAP value > ULN. It is defined as on-study BAP values within normal limits.|Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.|Participants with a baseline BAP value > ULN and at least 1 on-study value.||participants|||Number
728832|NCT00385580|Secondary|Number of Participants With a Baseline BAP Value > ULN, With a Decrease, Increase or no Change in BAP|BAP is a measure of bone metabolism. A decrease in BAP relative to baseline indicates a decrease in bone metabolism.|Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.|All treated participants who had a baseline BAP value >ULN and at least 1 on-study value.||participants|||Number
728833|NCT00385580|Secondary|Number of Participants With a Baseline BAP Value <= ULN, With a Decrease, Increase or no Change in BAP|BAP is a measure of bone metabolism. A decrease in BAP relative to the baseline indicates decrease in bone metabolism.|Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.|All treated participants who had a baseline BAP value <=ULN and at least 1 on-study value.||participants|||Number
728834|NCT00385580|Secondary|Median Number of Months of uNTx Response|uNTx is a measure of bone metabolism.The median number of months of uNTx response was calculated for participants with baseline uNTx =< ULN and uNTx progression during treatment, from first dose of dasatinib to uNTx progression.For participant with baseline uNTx above ULN, it was time from uNTx response to uNTx progression.For participants with baseline uNTx equal to or below ULN or uNTx response and no uNTx progression, the date of last uNTx assessment was used. Duration of uNTx response was not defined for participants with baseline value greater than ULN who never achieved uNTx responses.|Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.|Participants who demonstrated a uNTx response.||months||95% Confidence Interval|Median
728835|NCT00385580|Secondary|Number of Participants With a uNTx Response|uNTx is a measure of bone metabolism. uNTx response is defined for participants with baseline uNTx above ULN. It is defined as either on-study uNTx values decreasing to within normal limits or 35% or more decrease in uNTx from baseline, whichever happens first.|Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.|Participants with a baseline uNTx value > ULN and at least 1 on-study value.||participants|||Number
728836|NCT00385580|Secondary|Number of Participants With a Baseline uNTx Value >ULN, With a Decrease, Increase or no Change in uNTx|uNTx is a measure of bone metabolism. A decrease in the marker relative to baseline indicates a decrease in bone metabolism.|Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.|All treated participants who had a baseline uNTx value >ULN and at least 1 on-study value.||participants|||Number
728837|NCT00385580|Secondary|Number of Participants With a Baseline uNTx Value <=ULN, With a Decrease, Increase or no Change in uNTx|uNTx is a measure of bone metabolism. A decrease in the marker relative to baseline indicates a decrease in bone metabolism.|Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.|All treated participants who had a baseline uNTx value <=ULN and at least 1 on-study value.||participants|||Number
728838|NCT00385580|Secondary|Number of Participants With QTc Prolongation|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. QTc is the QT interval corrected for heart rate. A prolonged QT interval is a risk factor for ventricular tachyarrhythmias and sudden death.|From start of study drug therapy up to 30 days after the last dose.|All treated participants.||participants|||Number
728839|NCT00385580|Secondary|Number of Participants With Positive Urinalysis|Participants' urine samples were tested for the presence of blood, glucose and protein. If these substances were present in a participant’s urine, the results were given as “positive”.|Data was collected prior treatment with the study drug, Week 2, Week 4, Week 8, Week 12 , every 4 weeks thereafter and at the end of the treatment.|All treated participants.||participants|||Number
728840|NCT00385580|Secondary|Number of Participants With Abnormal Lactate Dehydrogenase (LD)|LDH is a laboratory safety parameter. Normal ranges for LD vary with both age and disease status, and another reason for variation in upper limit of normal (ULN) and lower limit of normal (LLN) is that LD was measured via a local (versus a standardized) laboratory. It is therefore not possible to provide one ULN and LLN for the population.|Data was collected prior treatment with the study drug, Week 2, Week 4, Week 8, Week 12, every 4 weeks thereafter and at the end of the treatment.|All treated participants.||participants|||Number
728841|NCT00385580|Secondary|Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Creatinine, Potassium, Sodium and Phosphorous|Abnormalities were graded per the NCI CTC, version 3.0 (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening). Grade 3 and 4 criteria are as follows: phosphorous: Grade 3: 1.0-<2.0 mg/dL, Grade 4: <1.0 mg/dL; sodium: Grade 3: 120-<130 or >155-160mEq/L, Grade 4: <120 or >160 mEq/L; creatinine: Grade 3: >3.0-6.0 * ULN, Grade 4: >6.0 * ULN; potassium: Grade 3: 2.5 -<3.0 or >6.0 -7.0 mEq/L, Grade 4: < 2.5 or >7.0 mEq/L.|Data was collected prior treatment with the study drug, Week 2, Week 4, Week 8, Week 12 , every 4 weeks thereafter and at the end of the treatment.|All treated participants.||participants|||Number
728842|NCT00385580|Secondary|Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Bilirubin and Calcium|Abnormalities were graded according to the NCI CTC, version 3.0 (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening). Grade 3 and 4 criteria are as follows: alanine aminotransferase, aspartate aminotransferase and alkaline phosphatase: Grade 3: 5.0-20.0 * ULN (upper limit of normal), Grade 4: >20.0 * ULN; calcium: Grade 3: 6.0-<7.0 or >12.5-13.5 mg/dL, Grade 4: <0.6->13.5 mg/dL; bilirubin: Grade 3: >3-10 * ULN, Grade 4: >10 * ULN.|Data was collected prior treatment with the study drug, Week 2, Week 4, Week 8, Week 12 , every 4 weeks thereafter and at the end of the treatment.|All treated participants.||participants|||Number
728843|NCT00385580|Secondary|Number of Participants With Grade 3-4 Hematology Abnormalities|Abnormalities were graded per the NCI CTC, version 3.0 criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening). Grade 3 and 4 criteria are as follows: Hemoglobin: Grade 3:6.5 - <8.0g/dL, Grade 4: <6.5g/dL. Platelets: Grade 3: 25.0 - <50.0*10^9/L, Grade 4: <25.0*10. Absolute Neutrophil Count (ANC): Grade 3: 0.5 - <1.0*10^9/L, Grade 4: <0.5*10^9/L. Leukocytes: Grade 3: 1.0 - <2.0*10^9/L, Grade 4: <1.0*10^9/L.|Data was collected prior treatment with the study drug, Week 2, Week 4, Week 8, Week 12 , every 4 weeks thereafter and at the end of the treatment.|All treated participants.||participants|||Number
728844|NCT00385580|Secondary|Number of Participants Who Experienced Drug-related SAEs, Drug-related AEs, Drug-related Grade 3/4 AEs and Discontinuations Due to Drug-related AEs.|Drug-related AEs are those events with a relationship to the study therapy of certain; probable; possible; or missing. Drug-related SAEs are those events with any relationship to the study therapy. Drug-related AEs were graded using the National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 3.0: Grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death. Participants who discontinued the study due to any drug-related AEs were also recorded.|From start of study drug therapy up to 30 days after the last dose.|All treated participants.||participants|||Number
728845|NCT00385580|Secondary|Number of Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AEs|AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to any AEs were recorded.|From start of study drug therapy up to 30 days after the last dose.|All treated participants.||participants|||Number
728846|NCT00385580|Secondary|Median Change From Baseline in Individual FAPSI Scores at Week 36|FAPSI-8:index of symptoms/concerns when assessing value of treatment for advanced prostate cancer.Participants respond to each item on 5-point Likert-type scale:0 (not at all) to 4 (very much).GP1:I have lack of energy,GP4:I have pain,GE6:I worry that my condition will get worse,C2:I am losing weight,P2:I have certain areas in my body where I experience significant pain,P3:My pain keeps me from doing things I want to do,P7:I have difficulty urinating,P8:My problems with urinating limit my activities. The number of participants for whom these data are available is too small for analysis.|Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.|All treated participants. The number of participants for whom this data are available is too small for analysis.|||||
728847|NCT00385580|Secondary|Median Change From Baseline in Individual FAPSI Scores at Week 24|FAPSI-8:symptom index of important clinician-rated symptoms/concerns to monitor when assessing value of treatment for advanced prostate cancer. Participants respond to each item on a 5-point Likert-type scale from 0 (not at all) to 4 (very much). GP1:I have lack of energy, GP4:I have pain, GE6:I worry that my condition will get worse, C2: I am losing weight, P2:I have certain areas in my body where I experience significant pain,P3:My pain keeps me from doing things I want to do, P7:I have difficulty urinating, P8:My problems with urinating limit my activities.|Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.|All treated participants.||Units on a scale||Full Range|Median
728859|NCT00385580|Secondary|Number of Months of Decrease in PSA by at Least 50% From Baseline|PSA is a marker of prostate cancer. The duration of PSA response is measured from the time that the first of the 2 consecutive measurements met the criteria for confirmed PSA response, until the date of the first of the 3 consecutive measurements that confirm PSA progression, or the date of disease progression, or the date of death.|Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.|Participants with a decrease in PSA by at least 50% from baseline||months|||Number
728848|NCT00385580|Secondary|Median Change From Baseline in Total FAPSI-8 Scores at Weeks 12, 24 and 36|The FAPSI-8 is a symptom index comprised of the most important clinician-rated symptoms or concerns to monitor when assessing the value of treatment for advanced prostate cancer. It includes 8 items developed to measure symptoms/concerns specific to prostate cancer such as fatigue, pain (3-items), weight loss, difficulty with urination (2-items) and concerns about the condition becoming worse. Participants respond to each item on a 5-point Likert-type scale from 0 (not at all) to 4 (very much).|Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.|All treated participants.||Units on a scale||Full Range|Median
728849|NCT00385580|Secondary|Median Change From Baseline in Individual FAPSI Scores at Week 12|FAPSI-8:symptom index of important clinician-rated symptoms/concerns to monitor when assessing value of treatment for advanced prostate cancer. Participants respond to each item on a 5-point Likert-type scale from 0 (not at all) to 4 (very much). GP1:I have lack of energy, GP4:I have pain, GE6:I worry that my condition will get worse, C2: I am losing weight, P2:I have certain areas in my body where I experience significant pain,P3:My pain keeps me from doing things I want to do, P7:I have difficulty urinating, P8:My problems with urinating limit my activities.|Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.|All treated participants.||Units on a scale||Full Range|Median
728850|NCT00385580|Secondary|Median Number of Months to Disease Progression|Measured from date of first dose to date of first 3 consecutive measurements that confirm PSA progression, date of disease progression,or death date.Disease progression:progression of target lesions or unequivocal progression of non-measurable lesions/disease as evaluated by computed tomography (CT) scan or magnetic resonance imaging (MRI),loss of PSA response or Investigator-defined clinical progression based on physical examination,history,symptoms,and ECOG-PS.For participants who did not progress or die,date of last PSA measurement or tumor assessment was used, whichever occurred first.|Prior to treatment with the study drug, Week 12 and every 12 weeks thereafter and at the end of the treatment.|All treated participants.||months||95% Confidence Interval|Median
728851|NCT00385580|Secondary|Number of Participants With Disease Progression|Disease progression: progression of target lesions or unequivocal progression of non-measurable lesions/disease as evaluated by computed tomography (CT) scan or magnetic resonance imaging (MRI), not as evaluated by bone scan (non-measurable lesions included visceral and bone lesions), loss of PSA response (only for participants who achieved a PSA response) or Investigator-defined clinical progression based on physical examination, history, symptoms, and ECOG-PS. For participants who did not progress or die, date of last PSA measurement or tumor assessment was used, whichever occurred first.|Prior to treatment with the study drug, Week 12 and every 12 weeks thereafter and at the end of the treatment.|All treated participants.||participants|||Number
728852|NCT00385580|Secondary|Percentage of Participants With Confirmed Improved Bone Scan|An improved bone scan was defined as 1 or more of the following: disappearance of at least 1 lesion, no new lesions appearing since the most recent prior assessment, or new pain not developing in an area that was previously visualized. A response is considered confirmed if it is noted on 2 examinations at least 4 weeks apart.|Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.|Participants with confirmed improved bone scan.||Percentage of Participants|||Number
728853|NCT00385580|Secondary|Number of Participants With a Confirmed Improved Bone Scan|An improved bone scan was defined as 1 or more of the following: disappearance of at least 1 lesion, no new lesions appearing since the most recent prior assessment, or new pain not developing in an area that was previously visualized. A response is considered confirmed if it is noted on 2 examinations at least 4 weeks apart.|Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.|All response-evaluable participants.||participants|||Number
728854|NCT00385580|Secondary|Number of Participants With CR, PR or SD|Disease control rate is defined as the number of participants whose best response was CR, PR or SD, per RECIST: CR: disappearance of all target/non-target lesions; PR: >= 30% decrease in the sum of the LDs of target lesions relative to the baseline sum LD; SD: neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR; PD: defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.|Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.|All response-evaluable participants.||participants|||Number
728855|NCT00385580|Secondary|Number of Participants With CR or PR|Tumor response was defined as the number of participants whose best response was CR or PR, per RECIST: CR: disappearance of all target/non-target lesions; PR: >= 30% decrease in the sum of the LDs of target lesions relative to the baseline sum LD|Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.|All response-evaluable participants.||participants|||Number
728856|NCT00385580|Secondary|Number of Participants With Increase in PSA Doubling Time|PSA is a marker of prostate cancer. PSA doubling time is defined as log 2 divided by the slope of the log PSA line. An increase in PSA doubling time indicates improvement in anti-tumor activity.|Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.|All PSA response-evaluable participants: participants who had 2 or more pre-treatment PSA measurements and at least 2 on-study PSA measurements and positive log slope pre-treatment and on-study measurements.||participants|||Number
728857|NCT00385580|Secondary|Number of Participants With Decrease in PSA Log Slope|PSA is a marker of prostate cancer. A decrease in PSA value is an early indicator of potential anti-tumor activity. Log (PSA) is assumed to have a linear relationship with time. The PSA log slope is defined as the slope of the log PSA line.|Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.|All PSA response-evaluable participants: participants who had 2 or more pre-treatment PSA measurements and at least 2 on-study PSA measurements.||participants|||Number
728858|NCT00385580|Secondary|Number of Participants With Decrease in PSA Velocity|PSA is a marker of prostate cancer. PSA velocity measures the rate of change of PSA values. A decrease in PSA values and hence PSA velocity is an early indicator of potential anti-tumor activity.|Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.|All PSA response-evaluable participants: participants who had 2 or more pre-treatment PSA measurements and at least 2 on-study PSA measurements.||participants|||Number
728948|NCT00385762|Primary|Sperm Morphology|percent of sperm with normal shape|2 months post initial visit|||percent of sperm with normal shape||Standard Deviation|Mean
728860|NCT00385580|Secondary|Percentage of Participants With a Decrease in PSA by at Least 50% From Baseline|PSA is a marker of prostate cancer and a PSA response is defined as a decrease in the PSA value by at least 50% from baseline for 2 successive evaluations, each at least 2 weeks apart, for a total of 3 measurements.|Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.|All PSA response-evaluable participants: participants who had pre-treatment PSA measurements and at least 2 on-study PSA measurements.||Percentage of Participants|||Number
728861|NCT00385580|Secondary|Number of Participants With a Decrease in PSA by at Least 50% From Baseline|PSA is a marker of prostate cancer and a PSA response is defined as a decrease in the PSA value by at least 50% from baseline, for 2 successive evaluations, each at least 2 weeks apart, for a total of 3 measurements.|Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.|All PSA response-evaluable participants: participants who had pre-treatment PSA measurements and at least 2 on-study PSA measurements.||participants|||Number
728862|NCT00385580|Primary|Percentage of Participants With a Response|Response = confirmed PSA response (decrease in PSA =>50% from baseline), confirmed improved bone scan (disappearance of => 1 lesion, no new lesions, new pain not developing), confirmed CR (disappearance of all lesions) or confirmed PR (=>30% in sum of LD of all lesions compared to baseline sum LD), SD (neither sufficient increase for PD [=>20% increase in sum of LD of all target lesions] nor sufficient shrinkage for PR), based on RECIST.|Within 2 weeks of first study drug administration, thereafter recorded every 4 weeks.|All treated participants.||Percentage of Participants||95% Confidence Interval|Number
728863|NCT00385580|Primary|Number of Participants With a Response|Response = confirmed prostate specific antigen (PSA) response (decrease in PSA =>50% from baseline), confirmed improved bone scan (disappearance of => 1 lesion, no new lesions, new pain not developing), confirmed complete response (CR: disappearance of all lesions) or confirmed partial response (PR: =>30% in sum of longest diameter [LD] of all lesions compared to baseline sum LD), stable disease (SD: neither sufficient increase for progressive disease [PD: =>20% increase in sum of LD of all target lesions] nor sufficient shrinkage for PR), based on Response Criteria in Solid Tumors [RECIST].|Within 2 weeks of first study drug administration, thereafter recorded every 4 weeks.|All treated participants.||participants|||Number
728864|NCT00385593|Secondary|Peak Expiratory Flow (PEF)|Peak expiratory flow (PEF)|6 months (end of the study)|||L/min||Full Range|Mean
728865|NCT00385593|Secondary|Change in the Asthma Control Questionnaire(ACQ) Score|The ACQ is a 7-point scale with scores ranging from 0 (very well controlled) to 6 (very badly controlled)|Daily 14 days prior to each of visit 2-4|||Scores on a scale||Full Range|Mean
728866|NCT00385593|Secondary|Use of Inhaled Steroids|Mean micrograms/day of inhaled steroids (beclomethasone dipropionate equivalents)|Baseline up to 6 months|||micrograms||Full Range|Mean
728867|NCT00385593|Secondary|Mean Use of as Needed Medication|Mean use of as needed medication during the treatment period|Baseline up to 6 months|||Inhalations||Full Range|Mean
728868|NCT00385593|Secondary|Total Number of Severe Exacerbations|Severe asthma exacerbation is defined as deterioration in asthma leading to at least one of Hospitalization/Emergency room (or equivalent) treatment due to asthma or Oral (GCS) treatment for at least 3 days.|Baseline up to 6 months|||Exacerbations|||Number
728869|NCT00385593|Primary|Time to First Severe Asthma Exacerbation|Severe asthma exacerbation is defined as deterioration in asthma leading to at least one of Hospitalization/Emergency room (or equivalent) treatment due to asthma or Oral Glucocorticosteroids (GCS) treatment for at least 3 days.|Baseline up to 6 months|||Days||Standard Deviation|Mean
728870|NCT00385671|Secondary|Number of Patients With Treatment-Emergent Elevated Laboratory Analytes|Treatment-emergent: within range at baseline, out of range after baseline. Ranges in Units/Liter (U/L). Aspartate Aminotransferase (AST): female (f): >34, male (m): >36. Alanine Aminotransferase (ALT): f:<69 years (yr) >34, ≥69yr >32; m: <69yr >43, ≥69yr >35. Total Bilirubin (TBili): >21. Gamma Glutamyl Transferase (GGT): f: <59yr >49, ≥59yr >50; m: <59yr >61, ≥59yr >50. Fasting Plasma Glucose (FPG): <59yr >6.4, ≥59yr >6.7. Hemoglobin A1C (HbA1C) >6%. Alkaline Phosphatase (AlkPhos): f: 18-50yr >106, 50-70yr >123, 70-80yr >164, ≥80yr >221; m: 18-50yr >129, 50-70yr >131, 70-80yr >156, ≥80yr >187|baseline through 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) and with baseline values within the normal range were included in the analysis.||participants|||Number
728871|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Hemoglobin A1C||baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||percent||Standard Deviation|Mean
728872|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Fasting Plasma Glucose||baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||millimole/liter||Standard Deviation|Mean
728873|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Total Bilirubin||baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||micromole/liter||Standard Deviation|Mean
728874|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Hepatic Enzyme Serum Levels|Aspartate aminotransferase = AST Alanine aminotransferase = ALT Gamma glutamyl transferase = GGT Alkaline phosphatase = AlkPhos|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||units/liter||Standard Deviation|Mean
728875|NCT00385671|Secondary|Number of Participants With Treatment-Emergent Changes in Body Weight|"Treatment-emergent high body weight: weight at last visit >=107% of baseline weight.
Treatment-emergent low body weight: weight at last visit <=93% of baseline weight."|baseline through 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||participants|||Number
728876|NCT00385671|Secondary|Number of Participants With Treatment-Emergent Elevated Heart Rate|Elevated heart rate: >=100 beats per minute (bpm) + an increase of >=10 bpm if baseline <100 bpm.|baseline through 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) and with baseline values within the normal range were included in the analysis.||participants|||Number
728949|NCT00385762|Primary|Sperm Motility|percent of sperm with movement|2 months post initial visit|||Percent of sperm with movement||Standard Deviation|Mean
728877|NCT00385671|Secondary|Number of Participants With Treatment-emergent Elevated Blood Pressure|"Elevated systolic blood pressure: >=130 millimeter mercury (mm Hg) + an increase of >=10 mm Hg if baseline <130 mm Hg.
Elevated diastolic blood pressure: >=85 mm Hg + an increase of >=10 mm Hg if baseline <85 mm Hg."|baseline through 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) and with baseline values within the normal range were included in the analysis.||participants|||Number
728878|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Body Weight|Least-squares means represent adjustment due to baseline severity and investigative site.|baseline through 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||kilogram||Standard Error|Least Squares Mean
728879|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Heart Rate|Least-squares means represent adjustment due to baseline severity and investigative site.|baseline through 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||beats per minute||Standard Error|Least Squares Mean
728880|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Blood Pressure|Least-squares means represent adjustment due to baseline severity and investigative site.|baseline through 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||millimeter mercury||Standard Error|Least Squares Mean
728881|NCT00385671|Secondary|Discontinuations for Abnormal Laboratory Analytes, Vital Signs, Overall and for Each Measure|Presented are numbers of participants who discontinued due to a change from baseline in laboratory analytes or vital signs.|baseline through 12 weeks|All randomized patients.||participants|||Number
728882|NCT00385671|Secondary|Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use)|This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represent the weekly mean of the scores of the average pain severity over the last 24 hours. Scores are based on daily assessments recorded by patients in their diaries. De novo: use of gabapentin for <56 contiguous days prior to randomization. Prior use: use of gabapentin for >=56 contiguous days prior to randomization. Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks, 9 weeks, 10 weeks, 11 weeks, 12 weeks|Analyzed were all participants with a baseline and at least 1 non-missing post-baseline value. Last observation carried forward analysis.||units on a scale||Standard Error|Least Squares Mean
728883|NCT00385671|Secondary|Weekly Mean Change From Baseline to 12 Weeks in 24 Hour Average Pain Severity - Only Participants Who Adhered to Key Protocol Requirements (Per-Protocol Population)|Ordinal scale: 0=no pain, 10=worst possible pain. Data=weekly mean of scores of average pain severity over last 24 hours (h). Scores: daily assessments recorded by patients in diaries. Only patients adhering to key protocol criteria included: baseline Weekly Mean 24h Average Pain Score ≥4; 80-120% compliant with study Drug, each visit; baseline Michigan Neuropathy Screening Instrument Physical Assessment Total Score ≥3; gabapentin taper ≤14 days, no HbA1c ≥12% post randomization; no contraindicated medications used. Least-squares means=adjustment due to baseline severity + investigative site.|baseline, 12 weeks|The per-protocol sub-population of all randomized participants with a baseline value and >= 1 non-missing post-baseline value (modified intent-to-treat population) was included in the analysis.||units on a scale||Standard Error|Least Squares Mean
728884|NCT00385671|Secondary|Weekly Mean Change in 24 Hour Average Pain Severity +/- Generalized Anxiety Disorder (GAD)|"This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represent the weekly mean of the scores of the average pain severity over the last 24 hours. Scores are based on daily assessments recorded by patients in their diaries.
It was planned to analyze participants stratified by the presence or absence of a co-morbidity with GAD. However, due to the low number of participants with GAD in the study this analysis was not possible."|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
728885|NCT00385671|Secondary|Time to First ≥ 2 Points Reduction in Weekly Mean 24 Hour Average Pain Score|This is the number of days required to first achieve a nominal outcome reflecting whether or not a clinically-important efficacy outcome was achieved. It is based on a comparison between baseline and post-baseline scores on an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Used were the weekly mean of the scores of the average pain severity over the last 24 hours. The weekly averages were based on daily assessments recorded by patients in their diaries.|baseline through 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||days||95% Confidence Interval|Median
728886|NCT00385671|Secondary|Time to First Sustained Response in Weekly Mean 24 Hour Average Pain Score|This is the number of days to first achieve an outcome using the weekly means of the 24-hour average pain severity via daily patient assessments using an ordinal scale (scores from 0 (no pain) to 10 (worst possible pain). Sustained response: ≥30% reduction, baseline to endpoint, with 30% reduction from baseline ≥2 weeks prior to endpoint, remaining at ≥20% reduction between. The median time to sustained response with some measure of dispersion could not be calculated for each treatment group.|baseline through 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||days||95% Confidence Interval|Median
728887|NCT00385671|Secondary|Time to First ≥ 50 % Reduction in Weekly Mean 24 Hour Average Pain Score|This is the number of days to first achieve ≥50% reduction, baseline to endpoint, in the weekly means of the 24-hour average pain severity via daily patient assessments using an ordinal scale (scores from 0 (no pain) to 10 (worst possible pain). The median time to first ≥50% reduction with some measure of dispersion could not be calculated for each treatment group. The number of patients who reached a ≥50% reduction in weekly mean 24 hour average pain score are presented in outcome measure 20.|baseline through 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||days||95% Confidence Interval|Median
728950|NCT00385762|Primary|Sperm Concentration|number of sperm per cubic centimeter of semen|2 months post initial visit|||number of sperm per cubic centimeter||Standard Deviation|Mean
728888|NCT00385671|Secondary|Time to First ≥ 30% Reduction in Weekly Mean 24 Hour Average Pain Score|This is the number of days required to first achieve a nominal outcome reflecting whether or not a clinically-important efficacy outcome was achieved. It is based on a comparison between baseline and post-baseline scores on an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Used were the weekly mean of the scores of the average pain severity over the last 24 hours. The weekly averages were based on daily assessments recorded by patients in their diaries.|baseline through 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||days||95% Confidence Interval|Median
728889|NCT00385671|Secondary|Summary of Number of Participants Who Discontinued|Number of participants who discontinued. The reasons for discontinuation are presented in the participant flow.|baseline through 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||participants|||Number
728890|NCT00385671|Secondary|Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale|The Resource Utilization Scale measures direct and indirect costs (collected only for US sites). Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Inpatient costs include costs associated with hospitalizations and time spent in emergency rooms and psychiatric rooms. Outpatient costs include costs associated with visits to various health care providers, home health care by health care providers, and partial care.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||participants|||Number
728891|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Beck Depression Inventory II (BDI-II) Total Score|A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe. Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
728892|NCT00385671|Secondary|Path Analysis of Improvement in Pain Through Improvement in Depressive Symptoms|Contribution to reduction in pain directly by treatment and indirectly by treatment through the reduction of depressive symptoms using path analysis. The direct treatment effect estimates the mean drug difference in pain reduction directly through treatment; the indirect treatment effect estimates the contribution that treatment plays to the mean drug difference in pain reduction indirectly through the reduction in mood symptoms; the total effect estimates the drug difference in reducing pain in sum through the specified path of direct and indirect treatment effects.|baseline through 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||coefficient|||Number
728893|NCT00385671|Secondary|Categorial Change From Baseline to 12 Weeks in Portland Neurotoxicity Scale - Total Score and Subscale Scores|The Portland Neurotoxicity Scale is a 15-item, patient-completed questionnaire designed to assess the degree of impact of anti-epileptic drug therapy on a number of cognitive and somatomotor parameters. Categories: better=negative change in score; same=no change in score; worse=positive change in score.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||participants|||Number
728894|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Portland Neurotoxicity Scale - Total Score and Subscale Scores|The Portland Neurotoxicity Scale is a 15-item, patient-completed questionnaire designed to assess the degree of impact of anti-epileptic drug therapy on a number of cognitive and somatomotor parameters. The total score ranges from 15-135 with higher scores indicating more toxicity. The cognitive toxicity score ranges from 10-90 and the somatomotor toxicity score ranges from 5-45, for both higher scores indicate more toxicity. Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
728895|NCT00385671|Secondary|Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores|14-item subject-rated scale assessing changes in sexual activity and functioning; structured interview/questionnaire, designed to measure medication related changes in sexual functioning. 5 dimensions of sexual behavior: pleasure; desire/frequency; desire/interest; arousal; orgasm. Total score: obtained across all 5 dimensions, ranges from 14 to 70. Subscale scores: desire/frequency=2-10; desire/interest=3-15; pleasure=1-5; arousal=3-15; orgasm=3-15. Higher scores = better sexual functioning. Categories: better=positive change in score; same=no change in score; worse=negative change in score.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) and with baseline values within the normal range were included in the analysis.||participants|||Number
728896|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores|14-item subject-rated scale assessing medication related changes in sexual activity + functioning. Structured interview/questionnaire. It measures five dimensions of sexual behavior: pleasure; desire/frequency; desire/interest; arousal; and orgasm. The total score is obtained across all 5 dimensions, ranging from 14 to 70. Subscale score ranges: desire/frequency=2-10; desire/interest=3-15; pleasure=1-5; arousal=3-15; orgasm=3-15. Higher scores = better sexual functioning. Least-squares means: adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
728897|NCT00385671|Secondary|Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation||baseline through 12 weeks|All participants who were enrolled in the study.||participants|||Number
728951|NCT00385762|Primary|Semen Volume|measured in mL|2 months post initial visit|||mL||Standard Deviation|Mean
728898|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Sheehan Disability Scale (SDS) - Total Score and Scores for Items 1 to 3|The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Total scores range from 0 to 30, higher values indicate greater disruption in the patient's life. Item 1 assesses the effect of the patient's symptoms on their work/school schedule, Item 2 on their social life/leisure activities, and Item 3 on their family life/home responsibilities. Subscales scores range: 0-10, higher values indicate greater disruption in the patient's life. Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
728899|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Leeds Sleep Evaluation Questionnaire (LSEQ) Subscales of Ease of Going to Sleep (GTS), Awakening (AFS), and Behavior Following Wakefulness (BFW), Quality of Sleep (QOS)|The LSEQ assesses the effects of psychoactive compounds on sleep and early morning behavior. Participants mark a series of 100 mm line analogue scales, indicating the direction and magnitude of any changes in behavioral state they experience following administration of the drug. Scores are represented in millimeters, higher scores indicate better sleep and better early morning behavior. Subscale score ranges: GTS=0-300, QOS=0-200, AFS=0-200, BFW=0-300. Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
728900|NCT00385671|Secondary|Number of Participants With a ≥ 2-points Reduction on the Weekly Average of the Daily 24-hour Average Pain Scale at 12 Weeks|This is a nominal outcome reflecting whether or not a clinically-important efficacy outcome was achieved at endpoint. It is based on a comparison between baseline and endpoint scores on an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Used were the weekly mean of the scores of the average pain severity over the last 24 hours. The weekly averages were based on daily assessments recorded by patients in their diaries.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||participants|||Number
728901|NCT00385671|Secondary|Number of Patients With a Reduction of ≥ 50% in Weekly Mean of 24 Hour Average Pain Score|This is a nominal outcome reflecting whether or not a clinically-important efficacy outcome was achieved at endpoint. It is based on a comparison between baseline and endpoint scores on an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Used were the weekly mean of the scores of the average pain severity over the last 24 hours. The weekly averages were based on daily assessments recorded by patients in their diaries.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||participants|||Number
728902|NCT00385671|Secondary|Number of Participants With ≥ 30% Reduction in the Weekly Mean 24 Hour Average Pain Score at 12 Weeks|This is a nominal outcome reflecting whether or not a clinically-important efficacy outcome was achieved at endpoint. It is based on a comparison between baseline and endpoint scores on an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Used were the weekly mean of the scores of the average pain severity over the last 24 hours. The weekly averages were based on daily assessments recorded by patients in their diaries.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||participants|||Number
728903|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Mean Interference Score|The Interference scores range from 0 (does not interfere) to 10 (completely interferes). There are 7 questions assessing the interference of pain in the past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
728904|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Enjoyment of Life|A self-reported scale that measures the interference of pain in the past 24 hours on enjoyment of life. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
728905|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Sleep|A self-reported scale that measures the interference of pain in the past 24 hours on sleep. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
728906|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Relations With Other People|A self-reported scale that measures the interference of pain in the past 24 hours on relations with other people. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
728907|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Normal Work|A self-reported scale that measures the interference of pain in the past 24 hours on normal work. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
728908|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Walking Ability|A self-reported scale that measures the interference of pain in the past 24 hours on walking ability. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
728909|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Mood|A self-reported scale that measures the interference of pain in the past 24 hours on mood. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
728910|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference: With General Activity|A self-reported scale that measures the interference of pain in the past 24 hours on general activity. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
728911|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: Pain Right Now|A self-reported scale that measures the severity of pain based on the pain right now. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
728912|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: Least Pain|A self-reported scale that measures the severity of pain based on the least pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
728913|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: Worst Pain|A self-reported scale that measures the severity of pain based on the worst pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 Weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
728914|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: 24-hour Average Pain|A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
728915|NCT00385671|Secondary|Patient's Global Impression of Improvement Scale (PGI - Improvement) at 12 Weeks|A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).|12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||units on a scale||Standard Deviation|Mean
728916|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Clinical Global Impression of Severity Scale (CGI Severity)|Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
728917|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Weekly Mean of the Daily Worst Pain Severity Score|This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represent the weekly mean of the scores of the daily worst pain severity over the last 24 hours. Scores are based on daily assessments recorded by patients in their diaries. Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
728918|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Weekly Mean of Nighttime Pain Severity|This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represent the weekly mean of the scores of the daily nighttime pain severity over the last 24 hours. Scores are based on daily assessments recorded by patients in their diaries. Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
728952|NCT00385801|Secondary|Amygdala Volume by MRI|Measure of Dispersion/Precision not calculated, and raw data are no longer available|12 weeks|Measure of Dispersion/Precision not calculated, and raw data are no longer available|||||
729355|NCT00389805|Secondary|Treatment Efficacy as Measured by RECIST (Phase I)|Response to therapy was evaluated every 2 cycles according to RECIST criteria.|Up to 36 months|All patients for whom response evaluation measurements were recorded at baseline and after 2 cycles.||Participants|||Count of Participants
728919|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Weekly Mean of Daily 24 Hour Average Pain Score, Duloxetine Compared With Duloxetine+Gabapentin|This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represent the weekly mean of the scores of the average pain severity over the last 24 hours. Scores are based on daily assessments recorded by patients in their diaries. Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
728920|NCT00385671|Primary|Mean Change From Baseline to 12 Weeks in Weekly Mean of Daily 24 Hour Average Pain Score, Pregabalin Compared With Duloxetine|This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represent the weekly mean of the scores of the average pain severity over the last 24 hours. Scores are based on daily assessments recorded by patients in their diaries. Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
728921|NCT00385684|Secondary|Pain Assessment in Advanced Dementia (PAINAD)|Pain intensity observational assessment for persons with severe dementia. Higher scores indicate more pain/discomfort.|6 weeks|||units on a scale||Standard Deviation|Mean
728922|NCT00385684|Primary|Pain Assessment in Advanced Dementia (PAINAD)|Pain intensity observational assessment for persons with severe dementia. Higher scores indicate more pain/discomfort. Scale range is 0-10.|Two (2) weeks|||units on a scale||Standard Deviation|Mean
728923|NCT00385723|Primary|ln(CES-D)|"log-transformed Center for Epidemiologic Studies Depression Scale (CES-D) score The CES-D is a self-report scale designed to measure current symptoms of depression rated on a four-point likert scale.
Scores range from 0-60, with higher scores indicating a higher frequency of depressive symptoms."|Baseline & 4 months|intention to treat||scores on a scale||Standard Error|Least Squares Mean
728924|NCT00385723|Primary|Serum ln(IL-6)|log-transformed serum Interleukin-6 (IL-6)|Baseline & 4 months|intention to treat||pg/ml (raw IL-6)||Standard Error|Least Squares Mean
728925|NCT00385723|Primary|Serum ln(TNF-a)|log-transformed serum Tumor Necrosis Factor-alpha (TNF-alpha)|Baseline & 4 months|intention to treat||pg/ml (raw TNF-a)||Standard Error|Least Squares Mean
728926|NCT00385736|Secondary|Proportion of Participants With Clinical Remission Per Mayo Score at Week 52 Among Participants Who Were Systemic Corticosteroid-free at Week 52|"Clinical remission per Mayo score is defined as a total Mayo score <= 2 and no individual subscore > 1.
The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores:
Stool Frequency Subscore, Rectal Bleeding Subscore, Endoscopy Subscore, and Physician's Global Assessment Subscore, each of which ranges from 0 (normal) to 3 (severe disease)."|Week 52|All randomized participants enrolled under any version of the protocol who took systemic corticosteroids (CS) at Baseline, received at least 1 dose of study drug, and were systemic CS-free at Week 52 were included. Nonresponder imputation was used; participants who dose escalated to adalimumab 40 mg ew were considered nonresponders post-escalation.||Proportion of participants|||Number
728927|NCT00385736|Secondary|Proportion of Participants With Stool Frequency Subscore Indicative of Mild Disease (<= 1) at Week 52|Stool Frequency Subscore ranges from 0-3 as follows: 0 = Normal number of stools for this participant, 1 = 1-2 stools more than normal, 2 = 3-4 stools more than normal, 3 = 5 or more stools more than normal|Week 52|All randomized participants (enrolled under any version of the protocol) who received at least 1 dose of study drug were included in this intent-to-treat analysis. Nonresponder imputation (NRI) was used; participants who dose escalated to adalimumab 40 mg ew were considered nonresponders after their dose escalation.||Proportion of participants|||Number
728928|NCT00385736|Secondary|Proportion of Participants With Physician's Global Assessment Subscore Indicative of Mild Disease (<= 1) at Week 52|"The Physician's Global Assessment Subscore acknowledges the 3 other subscores (Stool Frequency, Rectal Bleeding, and Endoscopy), the subject's daily record of abdominal discomfort and functional assessment, and other observations such as physical findings and the subject's performance status. Possible scores range from 0-3 as follows:
0 = Normal (other subscores are 0), 1 = Mild disease (other subscores are mostly 1), 2 = Moderate disease (other subscores are 1 to 2), 3 = Severe disease (other subscores are 2 to 3)"|Week 52|All randomized participants (enrolled under any version of the protocol) who received at least 1 dose of study drug were included in this intent-to-treat analysis. Nonresponder imputation (NRI) was used; participants who dose escalated to adalimumab 40 mg ew were considered nonresponders after their dose escalation.||Proportion of participants|||Number
728929|NCT00385736|Secondary|Proportion of Participants With Rectal Bleeding Subscore Indicative of Mild Disease (<= 1) at Week 52|"Rectal Bleeding Subscore ranges from 0-3 as follows:
0 = no blood seen, 1 = streaks of blood with stool less than half the time, 2 = obvious blood with stool most of the time, 3 = blood alone passed"|Week 52|All randomized participants (enrolled under any version of the protocol) who received at least 1 dose of study drug were included in this intent-to-treat analysis. Nonresponder imputation (NRI) was used; participants who dose escalated to adalimumab 40 mg ew were considered nonresponders after their dose escalation.||Proportion of participants|||Number
728930|NCT00385736|Secondary|Proportion of Participants With Mucosal Healing at Week 52|"Mucosal healing is defined as Endoscopy Subscore of 0 or 1 as assessed by flexible sigmoidoscopy. Possible scores range from 0-3 as follows:
0 = Normal or inactive disease, 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 2 = Moderate disease (marked erythema, absent vascular pattern, friability, erosions), 3 = Severe disease (spontaneous bleeding, ulceration)"|Week 52|All randomized participants (enrolled under any version of the protocol) who received at least 1 dose of study drug were included in this intent-to-treat analysis. Nonresponder imputation (NRI) was used; participants who dose escalated to adalimumab 40 mg ew were considered nonresponders after their dose escalation.||Proportion of participants|||Number
728953|NCT00385801|Secondary|Cocaine Craving|The University of Minnesota Cocaine Craving Scale was performed to assess cocaine craving. The scale contains 1 continuous scale for intensity and 2 categorical scales for frequency and duration of craving episodes. The continuous scale for craving intensity ranges from 0 (no craving at all in the past week) to 10 (a great deal of craving in the past week)|12 weeks|Mixed model repeated measures analysis of variance was performed.||units on a scale||Standard Deviation|Mean
728931|NCT00385736|Secondary|Proportion of Participants With Clinical Response Per Partial Mayo Score at Week 52|"Clinical response per partial Mayo score is defined as a decrease in partial Mayo score of >= 2 points and >= 30% from Baseline, plus either a decrease in rectal bleeding subscore of >= 1 point or an absolute rectal bleeding subscore of 0 or 1.
The partial Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 9 (severe disease) and is a composite of 3 subscores:
Stool Frequency Subscore, Rectal Bleeding Subscore, and Physician's Global Assessment Subscore, each of which ranges from 0 (normal) to 3 (severe disease)."|Week 52|All randomized participants (enrolled under any version of the protocol) who received at least 1 dose of study drug were included in this intent-to-treat analysis. Nonresponder imputation (NRI) was used; subjects who dose escalated to adalimumab 40 mg ew were considered nonresponders after their dose escalation.||Proportion of participants|||Number
728932|NCT00385736|Secondary|Proportion of Participants With Clinical Response Per Mayo Score at Week 52|"Clinical response per Mayo score is defined as a decrease in Mayo score of >= 3 points and >= 30% from Baseline, plus either a decrease in rectal bleeding subscore of >= 1 point or an absolute rectal bleeding subscore of 0 or 1.
The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores:
Stool Frequency Subscore, Rectal Bleeding Subscore, Endoscopy Subscore, and Physician's Global Assessment Subscore, each of which ranges from 0 (normal) to 3 (severe disease)."|Week 52|All randomized participants (enrolled under any version of the protocol) who received at least 1 dose of study drug were included in this intent-to-treat analysis. Nonresponder imputation (NRI) was used; participants who dose escalated to adalimumab 40 mg ew were considered nonresponders after their dose escalation.||Proportion of participants|||Number
728933|NCT00385736|Secondary|Proportion of Participants With Clinical Remission Per Partial Mayo Score at Week 52|"Clinical remission per partial Mayo score is defined as a partial Mayo score <= 2 and no individual subscore > 1.
The partial Mayo score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 9 (severe disease) and is a composite of 3 subscores:
Stool Frequency Subscore, Rectal Bleeding Subscore, and Physician's Global Assessment Subscore, each of which ranges from 0 (normal) to 3 (severe disease)."|Week 52|All randomized participants (enrolled under any version of the protocol) who received at least 1 dose of study drug were included in this intent-to-treat analysis. Nonresponder imputation (NRI) was used; participants who dose escalated to adalimumab 40 mg ew were considered nonresponders after their dose escalation.||Proportion of participants|||Number
728934|NCT00385736|Secondary|Proportion of Participants With Clinical Remission Per Mayo Score at Week 52|"Clinical remission per Mayo score is defined as a total Mayo score <= 2 and no individual subscore > 1.
The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores:
Stool Frequency Subscore, Rectal Bleeding Subscore, Endoscopy Subscore, and Physician's Global Assessment Subscore, each of which ranges from 0 (normal) to 3 (severe disease)."|Week 52|All randomized participants (enrolled under any version of the protocol) who received at least 1 dose of study drug were included in this intent-to-treat analysis. Nonresponder imputation (NRI) was used; participants who dose escalated to adalimumab 40 mg ew were considered nonresponders after their dose escalation.||Proportion of participants|||Number
728935|NCT00385736|Secondary|Ranked Secondary Endpoint #12: Proportion of IBDQ Responders at Week 8 (Adalimumab 80/40 Versus Placebo).|Response per the Inflammatory Bowel Disease Questionnaire (IBDQ) defined as a >= 16-point increase from Baseline in total IBDQ score. The IBDQ is a 32-item questionnaire consisting of 4 dimensions: bowel-related symptoms, systemic function, social function, and emotional status. The responses to each question within each domain range from 1 (significant impairment) to 7 (no impairment), with total score ranging from 32 (very poor) to 224 (perfect health-related quality of life).|Week 8|All participants enrolled after Amendment 3 to the study protocol (which introduced the adalimumab 80/40 treatment arm) and who received at least 1 dose of study drug were included in this intent-to-treat (ITT) analysis. Nonresponder imputation (NRI) was used.||Proportion of participants|||Number
728936|NCT00385736|Secondary|Ranked Secondary Endpoint #11: Proportion of IBDQ Responders at Week 8 (Adalimumab 160/80/40 Versus Placebo).|Response per the Inflammatory Bowel Disease Questionnaire (IBDQ) defined as a >= 16-point increase from Baseline in total IBDQ score. The IBDQ is a 32-item questionnaire consisting of 4 dimensions: bowel-related symptoms, systemic function, social function, and emotional status. The responses to each question within each domain range from 1 (significant impairment) to 7 (no impairment), with total score ranging from 32 (very poor) to 224 (perfect health-related quality of life).|Week 8|All participants enrolled after Amendment 3 to the study protocol (which introduced the adalimumab 80/40 treatment arm) and who received at least 1 dose of study drug were included in this intent-to-treat (ITT) analysis. Nonresponder imputation (NRI) was used.||Proportion of participants|||Number
728937|NCT00385736|Secondary|Ranked Secondary Endpoint #10: Proportion of Participants With Stool Frequency Subscore Indicative of Mild Disease (<= 1) at Week 8 (Adalimumab 80/40 Versus Placebo).|"Stool Frequency Subscore ranges from 0-3 as follows:
0 = Normal number of stools for this participant, 1 = 1-2 stools more than normal, 2 = 3-4 stools more than normal, 3 = 5 or more stools more than normal"|Week 8|All participants enrolled after Amendment 3 to the study protocol (which introduced the adalimumab 80/40 treatment arm) and who received at least 1 dose of study drug were included in this intent-to-treat (ITT) analysis. Nonresponder imputation (NRI) was used.||Proportion of participants|||Number
728938|NCT00385736|Secondary|Ranked Secondary Endpoint #9: Proportion of Participants With Physician's Global Assessment Subscore Indicative of Mild Disease (<= 1) at Week 8 (Adalimumab 80/40 Versus Placebo).|"The Physician's Global Assessment Subscore acknowledges the 3 other subscores (Stool Frequency, Rectal Bleeding, and Endoscopy), the subject's daily record of abdominal discomfort and functional assessment, and other observations such as physical findings and the subject's performance status. Possible scores range from 0-3 as follows:
0 = Normal (other subscores are 0), 1 = Mild disease (other subscores are mostly 1), 2 = Moderate disease (other subscores are 1 to 2), 3 = Severe disease (other subscores are 2 to 3)"|Week 8|All participants enrolled after Amendment 3 to the study protocol (which introduced the adalimumab 80/40 treatment arm) and who received at least 1 dose of study drug were included in this intent-to-treat (ITT) analysis. Nonresponder imputation (NRI) was used.||Proportion of participants|||Number
729356|NCT00389805|Secondary|Maximum Tolerated Dose of Bortezomib in Combination With Pemetrexel (Phase I)||Up to 36 months|||Mg/m^2|||Number
729357|NCT00389805|Secondary|Number of Patients With Toxicity by NCI CTC v3.0 (Phase I)|Adverse events possibly related to treatment, graded according to the NCI CTCAE v3.0.|Up to 36 months|||participants|||Number
728939|NCT00385736|Secondary|Ranked Secondary Endpoint #8: Proportion of Participants With Rectal Bleeding Subscore Indicative of Mild Disease (<= 1) at Week 8 (Adalimumab 80/40 Versus Placebo).|"Rectal Bleeding Subscore ranges from 0-3 as follows:
0 = no blood seen, 1 = streaks of blood with stool less than half the time, 2 = obvious blood with stool most of the time, 3 = blood alone passed"|Week 8|All participants enrolled after Amendment 3 to the study protocol (which introduced the adalimumab 80/40 treatment arm) and who received at least 1 dose of study drug were included in this intent-to-treat (ITT) analysis. Nonresponder imputation (NRI) was used.||Proportion of participants|||Number
728940|NCT00385736|Secondary|Ranked Secondary Endpoint #7: Proportion of Participants With Mucosal Healing at Week 8 (Adalimumab 80/40 Versus Placebo).|"Mucosal healing defined as Endoscopy Subscore of 0 or 1 as assessed by flexible sigmoidoscopy. Possible scores range from 0-3 as follows:
0 = Normal or inactive disease, 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 2 = Moderate disease (marked erythema, absent vascular pattern, friability, erosions), 3 = Severe disease (spontaneous bleeding, ulceration)"|Week 8|All participants enrolled after Amendment 3 to the study protocol (which introduced the adalimumab 80/40 treatment arm) and who received at least 1 dose of study drug were included in this intent-to-treat (ITT) analysis. Nonresponder imputation (NRI) was used.||Proportion of participants|||Number
728941|NCT00385736|Secondary|Ranked Secondary Endpoint #6: Proportion of Participants With Clinical Response Per Mayo Score at Week 8 (Adalimumab 80/40 Versus Placebo).|"Clinical response per Mayo score is defined as a decrease in Mayo score of >= 3 points and >= 30% from Baseline, plus either a decrease in rectal bleeding subscore of >= 1 point or an absolute rectal bleeding subscore of 0 or 1.
The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores:
Stool Frequency Subscore, Rectal Bleeding Subscore, Endoscopy Subscore, and Physician's Global Assessment Subscore, each of which ranges from 0 (normal) to 3 (severe disease)."|Week 8|All participants enrolled after Amendment 3 to the study protocol (which introduced the adalimumab 80/40 treatment arm) and who received at least 1 dose of study drug were included in this intent-to-treat (ITT) analysis. Nonresponder imputation (NRI) was used.||Proportion of participants|||Number
728942|NCT00385736|Secondary|Ranked Secondary Endpoint #5: Proportion of Participants With Stool Frequency Subscore Indicative of Mild Disease (<= 1) at Week 8 (Adalimumab 160/80/40 Versus Placebo).|Stool Frequency Subscore ranges from 0-3 as follows: 0 = Normal number of stools for this participant, 1 = 1-2 stools more than normal, 2 = 3-4 stools more than normal, 3 = 5 or more stools more than normal|Week 8|All participants enrolled after Amendment 3 to the study protocol (which introduced the adalimumab 80/40 treatment arm) and who received at least 1 dose of study drug were included in this intent-to-treat (ITT) analysis. Nonresponder imputation (NRI) was used.||Proportion of participants|||Number
728943|NCT00385736|Secondary|Ranked Secondary Endpoint #4: Proportion of Participants With Physician's Global Assessment Subscore Indicative of Mild Disease (<= 1) at Week 8 (Adalimumab 160/80/40 Versus Placebo).|"The Physician's Global Assessment Subscore acknowledges the 3 other subscores (Stool Frequency, Rectal Bleeding, and Endoscopy), the subject's daily record of abdominal discomfort and functional assessment, and other observations such as physical findings and the subject's performance status. Possible scores range from 0-3 as follows:
0 = Normal (other subscores are 0), 1 = Mild disease (other subscores are mostly 1), 2 = Moderate disease (other subscores are 1 to 2), 3 = Severe disease (other subscores are 2 to 3)"|Week 8|All participants enrolled after Amendment 3 to the study protocol (which introduced the adalimumab 80/40 treatment arm) and who received at least 1 dose of study drug were included in this intent-to-treat (ITT) analysis. Nonresponder imputation (NRI) was used.||Proportion of participants|||Number
728944|NCT00385736|Secondary|Ranked Secondary Endpoint #3: Proportion of Participants With Rectal Bleeding Subscore Indicative of Mild Disease (<= 1) at Week 8 (Adalimumab 160/80/40 Versus Placebo).|"Rectal Bleeding Subscore ranges from 0-3 as follows:
0 = no blood seen, 1 = streaks of blood with stool less than half the time, 2 = obvious blood with stool most of the time, 3 = blood alone passed"|Week 8|All participants enrolled after Amendment 3 to the study protocol (which introduced the adalimumab 80/40 treatment arm) and who received at least 1 dose of study drug were included in this intent-to-treat (ITT) analysis. Nonresponder imputation (NRI) was used.||Proportion of participants|||Number
728945|NCT00385736|Secondary|Ranked Secondary Endpoint #2: Proportion of Participants With Mucosal Healing at Week 8 (Adalimumab 160/80/40 Versus Placebo).|"Mucosal healing is defined as Endoscopy Subscore of 0 or 1 as assessed by flexible sigmoidoscopy. Possible scores range from 0-3 as follows:
0 = Normal or inactive disease, 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 2 = Moderate disease (marked erythema, absent vascular pattern, friability, erosions), 3 = Severe disease (spontaneous bleeding, ulceration)"|Week 8|All participants enrolled after Amendment 3 to the study protocol (which introduced the adalimumab 80/40 treatment arm) and who received at least 1 dose of study drug were included in this intent-to-treat (ITT) analysis. Nonresponder imputation (NRI) was used.||Proportion of participants|||Number
728946|NCT00385736|Secondary|Ranked Secondary Endpoint #1: Proportion of Participants With Clinical Response Per Mayo Score at Week 8 (Adalimumab 160/80/40 Versus Placebo).|"Clinical response per Mayo score is defined as a decrease in Mayo score of >= 3 points and >= 30% from Baseline, plus either a decrease in rectal bleeding subscore of >= 1 point or an absolute rectal bleeding subscore of 0 or 1.
The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores:
Stool Frequency Subscore, Rectal Bleeding Subscore, Endoscopy Subscore, and Physician's Global Assessment Subscore, each of which ranges from 0 (normal) to 3 (severe disease)."|Week 8|All participants enrolled after Amendment 3 to the study protocol (which introduced the adalimumab 80/40 treatment arm) and who received at least 1 dose of study drug were included in this intent-to-treat (ITT) analysis. Nonresponder imputation (NRI) was used.||Proportion of participants|||Number
728947|NCT00385736|Primary|Proportion of Participants With Clinical Remission Per Mayo Score at Week 8|"Clinical remission per Mayo score is defined as a total Mayo score <= 2 and no individual subscore > 1.
The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores:
Stool Frequency Subscore, Rectal Bleeding Subscore, Endoscopy Subscore, and Physician's Global Assessment Subscore, each of which ranges from 0 (normal) to 3 (severe disease)."|Week 8|All participants enrolled after Amendment 3 to the study protocol (which introduced the adalimumab 80/40 treatment arm) and who received at least 1 dose of study drug were included in this intent-to-treat (ITT) analysis. Nonresponder imputation (NRI) was used.||Proportion of participants|||Number
728954|NCT00385801|Primary|Cocaine Use by Quantitative Urine Samples|After randomization, participants provided urine samples every week for the first 3 weeks and then every 2 weeks for 8 weeks, up to 7 samples per participant. The average visits with cocaine negative urine samples per participant are reported below|12 weeks|Mean number of visits at which participants submitted urine samples with undetectable urine benzoylecgonine (UBE)||visit with negative UBE||Standard Deviation|Mean
728955|NCT00385801|Primary|Functional MRI Activation Patterns in the Nucleus Accumbens and Amygdala in Response to Cocaine Cues|Measure of Dispersion/Precision not calculated, and raw data are no longer available|12 weeks|Measure of Dispersion/Precision not calculated, and raw data are no longer available|||||
728956|NCT00385827|Secondary|Overall Survival (OS)|The OS is defined as the time from the date of start of treatment (for participants in Part 1) or randomization (for participants in Part 2) to death due to any cause. For participants who were alive at the time of analysis, OS was censored at the last contact date.|Start of treatment (Part 1)/Randomization (Part 2) until death, up to 2 years|Analysis population included all participants who received at least one dose of study drug in Part 1 and all randomized participants in Part 2.||days||95% Confidence Interval|Median
728957|NCT00385827|Secondary|Number of Participants With Prostate Specific Antigen (PSA) Response|The PSA response is defined as at least a 50% reduction in PSA from the Baseline value, confirmed by a second PSA value at least 3 weeks after initial documentation of PSA response.|Start of treatment (Part 1)/Randomization (Part 2), Week 1 of each cycle up to 1 month after last dose administration, and thereafter every 3 months until disease progression, up to 2 years|Analysis population included all participants who received at least one dose of study drug in Part 1 and all randomized participants in Part 2. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.||participants|||Number
728958|NCT00385827|Secondary|Number of Participants With Palliative Response|Palliative response was defined as a 2-point or greater reduction from baseline pain, without a categorical increase in prescribed disease-related analgesic (drug used to control pain) use or at least a categorical decrease in disease-related analgesic use without a concomitant (given at the same time) increase in pain. Each component required confirmation at least 3 weeks later.|Start of treatment (Part 1)/Randomization (Part 2), Week 1 of each cycle up to 1 month after last dose administration, and thereafter every 3 months up to 2 years|Data for this outcome measure was not analyzed because minimal efficacy analysis (primary and key secondary endpoints) was done due to early termination of study.|||||
728959|NCT00385827|Secondary|Time to Clinical Deterioration (TtCD)|The TtCD is defined as the time from the start of treatment (for participants in Part 1) or randomization (for participants in Part 2) until the first documented clinical deterioration (consists of pain requiring palliative (intended to relieve pain) intervention (a treatment given during the course of a research study), or death due to any cause, whichever occurs earlier.|Start of treatment (Part 1)/Randomization (Part 2), Week 1 of each cycle up to 1 month after last dose administration, and thereafter every 3 months until clinical deterioration or death, up to 2 years|Analysis population included all participants who received at least one dose of study drug in Part 1 and all randomized participants in Part 2.||days||95% Confidence Interval|Median
728960|NCT00385827|Primary|Part 2: Progression Free Survival (PFS)|The PFS is the time from the date of randomization until the first documented sign of progression (at least a 20 percent increase in the sum of the longest diameter [LD] of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new target or non-target lesions as per Response Evaluation Criteria in Solid Tumors [RECIST] or 3 or more new skeletal lesions on bone scan with confirmation of second bone scan or with clinical deterioration) or death, whichever occurs first.|Randomization, Week 12, then every 9 weeks until 1 month after last dose administration, then every 3 months until disease progression or death, up to 2 years|Intent-to-treat (ITT) population in Part 2 included all randomized participants.||days||95% Confidence Interval|Median
728961|NCT00385827|Primary|Part 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.|Baseline up to 12 weeks after last dose administration|Safety population in Part 1 included all participants who received at least one dose of study drug.||participants|||Number
728962|NCT00385840|Secondary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.|At Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom results were available for antibodies against at least one study vaccine antigen component.||fold increase||95% Confidence Interval|Mean
728963|NCT00385840|Secondary|Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.|A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.|At Day 0 and Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom results were available for antibodies against at least one study vaccine antigen component.||subjects|||Number
728964|NCT00385840|Secondary|Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.|At Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom results were available for antibodies against at least one study vaccine antigen component.||subjects|||Number
728965|NCT00385840|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia. The seropositivity cut-off assay was 1:10.|At Day 0 and Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom results were available for antibodies against at least one study vaccine antigen component.||titers||95% Confidence Interval|Geometric Mean
728966|NCT00385840|Primary|Number of Subjects With Any and Related Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE = Occurrence of any SAE regardless of intensity grade or relation to vaccination Related = SAE considered by the investigator to have a causal relationship to study vaccination.|During the entire study period (from Day 0 to Day 29)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||subjects|||Number
728967|NCT00385840|Primary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = Any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = Unsolicited AE that prevented normal activity. Related = Unsolicited AE assessed by the investigator as causally related to the vaccination.|During the 30-day (Days 0-29) post vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||subjects|||Number
728968|NCT00385840|Primary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.|Assessed solicited general symptoms were arthralgia, fatigue, fever, headache, muscle aches and shivering. Any = Incidence of a particular solicited general symptom regardless of intensity grade or relationship with the study vaccination. Any Fever = Axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C). Grade 3 symptom = Symptom that prevented normal activity. Grade 3 fever = Axillary temperature > 39.0°C. Related = Symptom considered by the investigator to have a causal relationship to study vaccination.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, on all vaccinated subjects with the vaccine administration documented and symptom sheet completed.||subjects|||Number
728969|NCT00385840|Primary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms.|Assessed solicited local symptoms were ecchymosis, pain, redness and swelling. Any = Incidence of a particular solicited local symptom regardless of intensity grade. Grade 3 pain = Pain that prevented normal everyday activity. Grade 3 redness/swelling/ecchymosis = Redness/swelling/ecchymosis above 50 millimeters (mm).|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, on all vaccinated subjects with the vaccine administration documented and symptom sheet completed.||subjects|||Number
728970|NCT00385918|Secondary|Step Activity Monitor|"The step activity monitor measures the total steps taken by an individual over a 48 hour time frame in the home environment.
This measure was only done on those participants that were able to walk in the community and did not use a wheelchair for community mobility, which represented 7 in the Lokomat training group out of the 12 total randomized to Lokomat training and 5 out of 6 of the people randomized to home stretching.
Please note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues."|Measured at Baseline (Time point 0) and 3 months|||steps||Standard Deviation|Mean
728971|NCT00385918|Secondary|10-meter Walk|"A functional capacity test to measure speed.
This measure was only done on those participants that were able to walk, which represented 9 in the Lokomat training group out of the 12 total randomized to Lokomat training, and 5 out of the 6 who were randomized to home stretching.
Note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues."|Measured at Baseline (Time point 0) and 3 months|||seconds||Standard Deviation|Mean
728972|NCT00385918|Secondary|Six Minute Walk|"A functional capacity test to evaluate walking distance during a 6-minute time frame.
This measure was only done on those participants that were able to walk for 6 minutes, which represented 9 in the Lokomat training group out of the 12 total randomized to Lokomat training, and 5 out of the 6 randomized to the home stretching group.
Please note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues."|Measured Baseline (Time point 0) and 3 months|||meters||Standard Deviation|Mean
728973|NCT00385918|Secondary|Bone Mineral Content|"DXA assessment of bone mineral content.
Please note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues."|Measured at Baseline (Time point 0), 3, and 6 months|||kg||Standard Deviation|Mean
728974|NCT00385918|Secondary|Lean Muscle Mass|"DXA measurement of total lean muscle mass.
Please note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues."|Measured at Baseline (Time point 0) and 3 months|||kg||Standard Deviation|Mean
729378|NCT00390182|Other Pre-specified|Time of Advanced/Recurrent Disease Without Distant Metastases.|Locally advanced/recurrent disease without distant metastases.|Participants were followed for an average of 8 years|||months||95% Confidence Interval|Median
728975|NCT00385918|Primary|Cardiovascular Fitness as Determined by Arm Cycle Ergometry VO2 Peak Assessments.|"Peak oxygen consumption during arm cycle ergometry as a measure of cardiovascular fitness.
Please note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues."|0, 1.5 and 3, 4.5, and 6 months|||ml/kg/min||Standard Deviation|Mean
728976|NCT00385918|Secondary|Percent Body Fat|"An assessment of percent body fat as determined by DXA analysis.
Please note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues."|Measured at Baseline (Time point 0), 3, and 6 months|||percent of total mass||Standard Deviation|Mean
728977|NCT00385918|Secondary|Body Mass|"DXA assessment of total body mass.
Please note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues."|Measured at Baseline (Time point 0), 3, and 6 months|||kg||Standard Deviation|Mean
728978|NCT00385918|Primary|Cardiovascular Fitness as Determined by Lokomat Peak VO2 Assessments|"Peak V02 measurements taken during Lokomat exercise in order to measure cardiovascular fitness.
Please note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues."|0, 1.5 and 3, 4.5, and 6 months|A single outlier point in the baseline data in one control subject was noted. Laboratory journal notes for this subject indicated that this individual had far more episodes of robotic treadmill stops during his baseline testing due to a high degree of spasticity. Given this, we felt justified in excluding this outlier from further data analysis.||ml/kg/min||Standard Deviation|Mean
728979|NCT00385944|Secondary|Correlation of MPA to 20 μM ADP and PRU|Pearson-correlation estimated between MPA to 20 μM ADP and Accumetrics VerifyNowTM P2Y12 PRU|Baseline through 29 days of treatment|||Correlation coefficient|||Number
728980|NCT00385944|Secondary|Number of Participants With Bleeding Events According to Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO)|Bleeding events will be classified according to the GUSTO definitions as follows: Severe or Life-Threatening Bleeding: any ICH OR any bleeding event resulting in substantial hemodynamic compromise requiring treatment. Moderate Bleeding: any bleeding event resulting in the need for transfusion. Minor bleeding: any other bleeding event that does not require transfusion or cause hemodynamic compromise.|14 days after maintenance dose (MD)|||Participants|||Number
728981|NCT00385944|Secondary|Number of Participants With Bleeding Events According to Thrombolysis in Myocardial Infarction Study Group (TIMI) Criteria|Bleeding events will be classified as Major Bleeding, Minor Bleeding, or Insignificant Bleeding according to the TIMI criteria. Major bleeding: any intracranial hemorrhage (ICH) OR any clinically overt bleeding (including bleeding evident on imaging studies) associated with a fall in hemoglobin (Hgb) of ≥5 gm/dL from baseline. Minor Bleeding: any clinically overt bleeding associated with a fall in Hgb of ≥3 grams/deciliter (gm/dL) but <5 gm/dL from baseline. Insignificant bleeding: any bleeding event that does not meet criteria for a Major or Minor bleed.|14 days after maintenance dose (MD)|||Participants|||Number
728982|NCT00385944|Secondary|MPA to 20 μM ADP at 14 Days After the Second Maintenance Dose (MD)|Maximum platelet aggregation to 20 μM ADP was assessed by LTA.|14 days after the second maintenance dose (MD)|Subjects providing evaluable MPA to 20 μM ADP at Day 29.||Percentage aggregation||Standard Deviation|Mean
728983|NCT00385944|Secondary|MPA to 20 μM ADP at 14 Days After the First Maintenance Dose (MD)|Maximum platelet aggregation to 20 μM ADP was assessed by LTA.|14 days after the first maintenance dose (MD)|Subjects providing evaluable MPA to 20 μM ADP at 14 days after the first maintenance dose (MD)||Percentage aggregation||Standard Deviation|Mean
728984|NCT00385944|Secondary|Change in MPA to 20 μM ADP From 6-18 Hrs Post Loading Dose (LD) to 14 Days After the First Maintenance Dose (MD)|Maximum platelet aggregation to 20 μM ADP was assessed by LTA.|6-18 hrs post loading dose (LD) to 14 days after the first maintenance dose (MD)|||Percentage aggregation||Standard Deviation|Mean
728985|NCT00385944|Secondary|Change in MPA to 20 μM ADP From Baseline to 6-18 Hrs Post Loading Dose (LD)|Maximum platelet aggregation to 20 μM ADP was assessed by LTA.|Baseline to 6-18 hrs post loading dose (LD)|Note: This was calculated only for subjects with a true clopidogrel-free measure at baseline (Visit 1)||Percentage aggregation||Standard Deviation|Mean
728986|NCT00385944|Secondary|Poor Responder of MPA to 20 μM ADP Following Maintenance Dose (MD)|Poor responder is defined as MPA to 20 μM ADP >75th percentile of the value at 6-18 hours post-clopidogrel LD.|14 days after maintenance dose (MD)|||Participants|||Number
728987|NCT00385944|Secondary|P2Y12 Reaction Units (PRU)|P2Y12 Reaction Units (PRU) assessed by Accumetrics Verify NowTM P2Y12. PRU represents the rate and extent of adenosine (ADP)-stimulated platelet aggregation. Lower values indicate greater P2Y12 platelet inhibition.|14 days after maintenance dose (MD)|||PRU||Standard Deviation|Mean
728988|NCT00385944|Secondary|Platelet Reactivity Index (PRI)|"Platelet Reactivity Index percentage was assessed by Vasodilator-stimulated phosphoprotein (VASP). PRI percent (%) was calculated using the median fluorescence intensity (MFI) of samples included with prostaglandin E1 (PGE1) and ADP, according to the following formula:
PRI%=[(MFI(PGE1)-MFI(PGE1 + ADP)/MFI(PGE1)]x100
Lower PRI% values indicate greater P2Y12 receptor blockade."|14 days after maintenance dose (MD)|||Percentage PRI||Standard Deviation|Mean
728989|NCT00385944|Secondary|Inhibition of Residual Platelet Aggregation (IRPA) to 5 μM ADP|"IRPA is calculated as a percent decrease of RPA from baseline using the following formula:
([RPA at baseline – RPA at time of postbaseline] / RPA at baseline) x 100%"|14 days after maintenance dose (MD)|Note: This was calculated only for subjects with a true clopidogrel-free measure at baseline (Visit 1)||Percentage inhibition||Standard Deviation|Mean
728990|NCT00385944|Secondary|Inhibition of Residual Platelet Aggregation (IRPA) to 20 μM ADP|"IRPA is calculated as a percent decrease of RPA from baseline using the following formula:
([RPA at baseline – RPA at time of postbaseline] / RPA at baseline) x 100%"|14 days after maintenance dose (MD)|Note: This was calculated only for subjects with a true clopidogrel-free measure at baseline (Visit 1)||Percentage inhibition||Standard Deviation|Mean
728991|NCT00385944|Secondary|Inhibition Platelet Aggregation (IPA) to 5 μM ADP|"IPA is calculated as a percent decrease of MPA from baseline using the following formula:
([MPA at baseline – MPA at time of postbaseline] / MPA at baseline) x 100%"|14 days after maintenance dose (MD)|Note: This was calculated only for subjects with a true clopidogrel-free measure at baseline (Visit 1)||Percentage inhibition||Standard Deviation|Mean
728992|NCT00385944|Secondary|Inhibition Platelet Aggregation (IPA) to 20 μM ADP|"IPA is calculated as a percent decrease of MPA from baseline using the following formula:
([MPA at baseline – MPA at time of postbaseline] / MPA at baseline) x 100%"|14 days after maintenance dose (MD)|Note: This was calculated only for subjects with a true clopidogrel-free measure at baseline (Visit 1)||Percentage inhibition||Standard Deviation|Mean
728993|NCT00385944|Secondary|Mean Residual Platelet Aggregation (RPA) to 5 µM ADP|Residual platelet aggregation is the percentage (%) aggregation value as measured by LTA at 6 minutes after the addition of ADP.|14 days after maintenance dose (MD)|||Percentage aggregation||Standard Deviation|Mean
728994|NCT00385944|Secondary|Mean Residual Platelet Aggregation (RPA) to 20 µM ADP|Residual platelet aggregation is the percentage (%) aggregation value as measured by LTA at 6 minutes after the addition of ADP.|14 days after maintenance dose (MD)|||Percentage aggregation||Standard Deviation|Mean
728995|NCT00385944|Secondary|MPA to 5 μM ADP|Maximum platelet aggregation to 5 μM ADP was assessed by LTA.|14 days after maintenance dose (MD)|||Percentage aggregation||Standard Deviation|Mean
728996|NCT00385944|Primary|Maximum Platelet Aggregation (MPA) to 20 Micromolar (μM) Adenosine Diphosphate (ADP)|Maximum platelet aggregation (MPA) to 20 μM adenosine diphosphate (ADP) was assessed by light transmission aggregometry (LTA).|14 days after maintenance dose (MD)|The primary analysis was performed on the intent-to-treat (ITT) population, that is, all randomized subjects with a maintenance dose MPA measured for at least one of the treatments.||Percentage aggregation||Standard Deviation|Mean
728997|NCT00385996|Primary|Safety of Tarceva in the Neoadjuvant Setting|Safety will be evaluated by describing the incidence of AEs, including SAEs and discontinuation of study drug due to AEs, and incidence of abnormal clinical laboratory values from day 1 of treatment.|From the onset of the AE until 30 days after the last study drug dose, until recovery is noted, or until the Investigator determines the patient's condition is stable.|Per protocol||Participants|||Number
728998|NCT00385996|Secondary|Safety||Day 1 of treatment to 2 years.||||||
728999|NCT00385996|Secondary|Time-to-progression and Disease-free Survival.||Every 3 months for the first 6 months, then yearly for 2 years.||||||
729000|NCT00385996|Primary|Response Rate Defined as the Percentage of Subjects Achieving at Least 50% Tumor Volume Reduction.|High resolution CT scans for response assessment were obtained at baseline and within 1 week after completion of erlotinib treatment. Volumetric and maximum diameter (RECIST) response criteria was determined by a radiologist blinded to the sequence of treatment. Response rate (RR) is defined as the percentage of subjects achieving at least 50% tumor volume reduction.|High resolution CT scans for response assessment will be obtained after 3 weeks of treatment with Tarceva®.|Per protocol||Percentage of participants|||Number
729001|NCT00386009|Secondary|Clinically Adverse and Statistically Significant Changes From Baseline to 12 Week Endpoint in Laboratory Tests|Laboratory tests that were statistically significant and clinically adverse would be reported for safety.|Baseline and 12 weeks|All randomized participants.||significant and clinically adverse labs|||Number
729002|NCT00386009|Secondary|Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Total Score|The IPSS Total Score is obtained by combining the scores of the responses to the 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.|12 weeks|Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.||units on a scale||Standard Deviation|Mean
729003|NCT00386009|Secondary|Change From Baseline to 12 Week Endpoint in Bladder Volume at First Involuntary Detrusor Contraction|Assessed in participants with involuntary detrusor contractions during the bladder filling at both baseline and endpoint.|Baseline and 12 weeks|Number of participants in the Primary Analysis Population with involuntary detrusor contractions during bladder filling at both baseline and endpoint.||milliliters||Standard Deviation|Mean
729004|NCT00386009|Secondary|Presence of Involuntary Detrusor Contractions During Bladder Filling||Baseline and 12 weeks|Number of participants randomized, had started study medication, had both a baseline and an end of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.||participants|||Number
729005|NCT00386009|Secondary|Change From Baseline to 12 Week Endpoint in Bladder Outlet Obstruction Index (BOOI) Measured During Pressure-Flow Studies|BOOI, formerly known as the Abrams-Griffith number, was derived from the equation PdetQmax - 2Qmax. Scores: <20 means unobstructed, 20-40 means equivocol, >40 means obstructed. An increase means worsening of obstruction, a decreased means lessening of obstruction (improvement).|Baseline and 12 weeks|Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.||units on a nomogram||Standard Deviation|Mean
729006|NCT00386009|Secondary|Change From Baseline to 12 Week Endpoint in Bladder Contractility Index (BCI) Measured During Pressure-Flow Studies|BCI was derived from the equation PdetQmax + 5Qmax. Scores: <100 means weak, 100-150 menas normal, >150 means strong. A decrease means a decrease in contractility of the bladder.|Baseline and 12 weeks|Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.||units on a nomogram||Standard Deviation|Mean
729007|NCT00386009|Secondary|Change From Baseline to 12 Week Endpoint in Maximum Detrusor Pressure (Max Pdet) Measured During Pressure-Flow Studies|Max Pdet was defined as the maximum detrusor pressure observed during voiding.|Baseline and 12 weeks|Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.||centimeters of water (cm H20)||Standard Deviation|Mean
729008|NCT00386009|Secondary|Change From Baseline to 12 Week Endpoint in Volume of Voided Urine (Vcomp) Measured During Pressure-Flow Studies|Vcomp was defined as the volume of voided urine measured during pressure-flow tests.|Baseline and 12 weeks|Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.||milliliters||Standard Deviation|Mean
729009|NCT00386009|Secondary|Change From Baseline to 12 Week Endpoint in Mean Urinary Flow Rate (Qave) Measured During Pressure-Flow Studies|Qave was measured during pressure-flow tests.|Baseline and 12 weeks|Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.||milliliters per second||Standard Deviation|Mean
729010|NCT00386009|Secondary|Change From Baseline to 12 Week Endpoint in Peak Urinary Flow Rate (Qmax) Measured During Pressure-Flow Studies|Qmax was measured duirng pressure-flow tests.|Baseline and 12 weeks|Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.||milliliters per second||Standard Deviation|Mean
729011|NCT00386009|Secondary|Change From Baseline to 12 Week Endpoint in Bladder Voiding Efficiency (BVE) Measured During Free-Flow Studies|Bladder voiding efficiency was defined as (Vcomp/total bladder capacity) X 100 (obtained when the bladder was full).|Baseline and 12 weeks|Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.||milliliters||Standard Deviation|Mean
729012|NCT00386009|Secondary|Change From Baseline to 12 Week Endpoint in Total Bladder Capacity Measured During Free-Flow Studies|Total bladder capacity was defined as Vcomp + PVRcath (obtained when the bladder was full).|Baseline and 12 weeks|Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.||milliliters||Standard Deviation|Mean
729013|NCT00386009|Secondary|Change From Baseline to 12 Week Endpoint in Postvoid Residual Volume (PVRcath) Measured During Free-Flow Studies|PVRcath is the volume of urine remaining int he bladder after voiding, measured by catheterization.|Baseline and 12 weeks|Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.||milliliters||Standard Deviation|Mean
729014|NCT00386009|Secondary|Change From Baseline to 12 Week Endpoint in Volume of Voided Urine (Vcomp) Measured During Free-Flow Studies||Baseline and 12 weeks|Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.||milliliters||Standard Deviation|Mean
729015|NCT00386009|Secondary|Change From Baseline to 12 Week Endpoint in Mean Urinary Flow Rate (Qave) Measured During Free-Flow Studies|Qave was measured during free-flow tests using a standard calibrated flow meter.|Baseline and 12 weeks|Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.||millilters per second||Standard Deviation|Mean
729016|NCT00386009|Secondary|Change From Baseline to 12 Week Endpoint in Peak Urinary Flow Rate (Qmax) Measured During Free-Flow Studies|Qmax was measured during free-flow tests using a standard calibrated flow meter.|Baseline and 12 weeks|Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.||milliliters per second||Standard Deviation|Mean
729017|NCT00386009|Primary|Change From Baseline to 12 Week Endpoint in Detrusor Pressure at Peak Urinary Flow Rate (PdetQmax)||Baseline and 12 weeks|Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.||centimeters of water (cm H20)||Standard Deviation|Mean
729018|NCT00386022|Primary|Effect of Estrogen on Pituitary Response to GnRH|LH and FSH responses to each of 4 GnRH doses, expressed as change in amplitude [amp] from peak to nadir between plus estrogen and baseline conditions|Peak hormone level within 2 hours post GnRH doses|||IU/L||Standard Error|Mean
729019|NCT00386022|Primary|Pituitary Response to GnRH|Baseline LH and FSH responses to each of 4 GnRH doses - peak to nadir amplitude expressed as percent (%) change from nadir|Peak hormone level within 2 hours post GnRH doses|||Percent change||Standard Error|Mean
729020|NCT00386100|Secondary|Percent Change From Baseline in Bone Alkaline Phosphatase (BSAP) at Weeks 20, 56, and 80|Blood was taken for measurement of BSAP. Percent change from baseline was based on log transformed data. Standard error, SE; Wk, Week; %, percent. This outcome measure was analyzed for a subset of participants in the bone study only. n is the number of evaluable participants, which is the number of participants with a value at baseline and at the specified visit for the parameter of interest.|Baseline and Weeks 20, 56, and 80|Week 20 Evaluable for the Bone Sub-study Population. This is a subset of the bone sub-study with LOCF from Week 20. Only participants with BSAP measurements at Week 20 or later were included.||percent change|||Number
729021|NCT00386100|Secondary|Percent Change From Baseline in Procollagen Type-1 N-propeptide (P1NP) at Weeks 20, 56, and 80|Blood was taken for measurement of P1NP. Percent change from baseline was based on log transformed data. Standard error, SE; Wk, Week; %, percent. This outcome measure was analyzed for a subset of participants in the bone study only. n is the number of evaluable participants, which is the number of participants with a value at baseline and at the specified visit for the parameter of interest.|Baseline and Weeks 20, 56, and 80|Week 20 Evaluable for the Bone Sub-study Population. This is a subset of the bone sub-study with LOCF from Week 20. Only participants with P1NP measurements at Week 20 or later were included.||percent change|||Number
729022|NCT00386100|Secondary|Percent Change From Baseline in C-terminal Telopeptide (CTX) at Weeks 20, 56, and 80|Blood was taken for measurement of CTX. Percent change from baseline was based on log transformed data. Standard error, SE; Wk, Week; %, percent. This outcome measure was analyzed for a subset of participants in the bone study only. n is the number of evaluable participants, which is the number of participants with a value at baseline and at the specified visit for the parameter of interest.|Baseline and Weeks 20, 56, and 80|Week 20 Evaluable for the Bone Sub-study Population. This is a subset of the bone sub-study with LOCF from Week 20. Only participants with CTX measurements at Week 20 or later were included.||percent change|||Number
729023|NCT00386100|Secondary|Percent Change From Baseline in Estradiol at Weeks 20, 56, and 80|Blood was taken for measurement of estradiol. Percent change from baseline was based on log transformed data. Standard error, SE; Wk, Week; %, percent. This outcome measure was analyzed for a subset of female participants in the bone study only. n is the number of evaluable participants, which is the number of female participants with a value at baseline and at the specified visit for the parameter of interest.|Baseline and Weeks 20, 56, and 80|Week 20 Evaluable for the Bone Sub-study Population. This is a subset of the bone sub-study with LOCF from Week 20. Only participants with estradiol measurements at Week 20 or later were included.||percent change|||Number
729024|NCT00386100|Secondary|Percent Change From Baseline in 25-hydroxy Vitamin D at Week 80|Blood was taken for measurement of 25-hydroxy vitamin D. Percent change from baseline was based on log transformed data. Standard error, SE; Wk, Week; %, percent. This outcome measure was analyzed for a subset of participants in the bone study only. n is the number of evaluable participants, which is the number of participants with a value at baseline and at the specified visit for the parameter of interest.|Baseline and Week 80|Week 20 Evaluable for the Bone Sub-study Population. This is a subset of the bone sub-study with LOCF from Week 20. Only participants with 25-hydroxy vitamin D measurements at Week 20 or later were included.||percent change|||Number
729025|NCT00386100|Secondary|Percent Change From Baseline in Intact Parathyroid Hormone at Week 80|Blood was taken for measurement of intact parathyroid hormone. Percent change from baseline was based on log transformed data. Standard error, SE; Wk, Week; %, percent. This outcome measure was analyzed for a subset of participants in the bone study only. n is the number of evaluable participants, which is the number of participants with a value at baseline and at the specified visit for the parameter of interest.|Baseline and Week 80|Week 20 Evaluable for the Bone Sub-study Population. This is a subset of the bone sub-study with LOCF from Week 20. Only participants with intact parathyroid hormone measurements at Week 20 or later were included.||percent change|||Number
729026|NCT00386100|Secondary|Percent Change From Baseline in Serum Calcium at Weeks 12, 32, 56, and 80|Blood was taken for measurement of serum calcium. Percent change from baseline was based on log transformed data. Geometric mean, GM; standard error, SE. This outcome measure was analyzed for a subset of participants in the bone study only. n is the number of evaluable participants, which is the number of participants with a value at baseline and at the specified visit for the parameter of interest.|Baseline and Weeks 12, 32, 56, and 80|Week 20 Evaluable for the Bone Sub-study Population. This is a subset of the bone sub-study with LOCF from Week 20. Only participants with serum calcium measurements at Week 20 or later were included.||percent change|||Number
729027|NCT00386100|Secondary|Percent Change From Baseline in Total Body BMD at Weeks 20, 56, and 80 (Bone Sub-study Subset of Participants)|BMD was measured by dual X-ray absorptiometry (DXA). The percent change from baseline in BMD at a given timepoint was defined at the participant level by the following formula: percent change = (BMD at given week minus BMD at baseline)/BMD at baseline x 100. This outcome measure was analyzed for a subset of participants in the bone study only.|Baseline and Weeks 20, 56, and 80|Week 20 Evaluable for the Bone Sub-study Population. This is a subset of the bone sub-study with LOCF from Week 20. Only participants with BMD assessment(s) at Week 20 or later were included.||percent change||Standard Error|Mean
729028|NCT00386100|Secondary|Percent Change From Baseline in Distal Radius BMD at Weeks 20, 56, and 80 (Bone Sub-study Subset of Participants)|BMD was measured by dual X-ray absorptiometry (DXA). The percent change from baseline in BMD at a given timepoint was defined at the participant level by the following formula: percent change = (BMD at given week minus BMD at baseline)/BMD at baseline x 100. This outcome measure was analyzed for a subset of participants in the bone study only.|Baseline and Weeks 20, 56, and 80|Week 20 Evaluable for the Bone Sub-study Population. This is a subset of the bone sub-study with LOCF from Week 20. Only participants with BMD assessment(s) at Week 20 or later were included.||percent change||Standard Error|Mean
729029|NCT00386100|Secondary|Percent Change From Baseline in Femoral Neck BMD at Weeks 20, 56, and 80 (Bone Sub-study Subset of Participants)|BMD was measured by dual X-ray absorptiometry (DXA). The percent change from baseline in BMD at a given timepoint was defined at the participant level by the following formula: percent change = (BMD at given week minus BMD at baseline)/BMD at baseline x 100. This outcome measure was analyzed for a subset of participants in the bone study only.|Baseline and Weeks 20, 56, and 80|Week 20 Evaluable for the Bone Sub-study Population. This is a subset of the bone sub-study with LOCF from Week 20. Only participants with BMD assessment(s) at Week 20 or later were included.||percent change||Standard Error|Mean
729030|NCT00386100|Secondary|Percent Change From Baseline in Trochanter BMD at Weeks 20, 56, and 80 (Bone Sub-study Subset of Participants)|BMD was measured by dual X-ray absorptiometry (DXA). The percent change from baseline in BMD at a given timepoint was defined at the participant level by the following formula: percent change = (BMD at given week minus BMD at baseline)/BMD at baseline x 100. This outcome measure was analyzed for a subset of participants in the bone study only.|Baseline and Weeks 20, 56, and 80|Week 20 Evaluable for the Bone Sub-study Population. This is a subset of the bone sub-study with LOCF from Week 20. Only participants with BMD assessment(s) at Week 20 or later were included.||percent change||Standard Error|Mean
729031|NCT00386100|Secondary|Percent Change From Baseline in Total Hip BMD at Weeks 20, 56, and 80 (Bone Sub-study Subset of Participants)|BMD was measured by dual X-ray absorptiometry (DXA). The percent change from baseline in BMD at a given timepoint was defined at the participant level by the following formula: percent change = (BMD at given week minus BMD at baseline)/BMD at baseline x 100. This outcome measure was analyzed for a subset of participants in the bone study only.|Baseline and Weeks 20, 56, and 80|Week 20 Evaluable for the Bone Sub-study Population. This is a subset of the bone sub-study with LOCF from Week 20. Only participants with BMD assessment(s) at Week 20 or later were included.||percent change||Standard Error|Mean
729032|NCT00386100|Secondary|Percent Change From Baseline in Lumbar Spine Bone Mass Density (BMD) at Weeks 20, 56, and 80 (Bone Sub-study Subset of Participants)|BMD was measured by dual X-ray absorptiometry (DXA). The percent change from baseline in BMD at a given timepoint was defined at the participant level by the following formula: percent change = (BMD at given week minus BMD at baseline)/BMD at baseline x 100%. This outcome measure was analyzed for a subset of participants in the bone study only.|Baseline and Weeks 20, 56, and 80|Week 20 Evaluable for the Bone Sub-study Population. This is a subset of the bone sub-study with LOCF from Week 20. Only participants with BMD assessment(s) at Week 20 or later were included.||percent change||Standard Error|Mean
729033|NCT00386100|Secondary|Number of Participants at Final Dose Level||Baseline to Week 80 or withdrawal|Safety population. This population consisted of all participants who were randomized and received at least one dose of the study medication.||participants|||Number
729034|NCT00386100|Secondary|Slope of Delta-cell Function as Estimated by the Ratio deltaI/deltaG|The ratio Delta I/Delta G is calculated based on the oral glucose tolerance test (OGTT), where Delta I = (30 minute immunoreactive insulin minus 0 minute immunoreactive insulin) and Delta G = (30 minute plasma glucose minus 0 minute plasma glucose). The 0 minute values are fasting insulin and glucose; the 30 minute values are taken 30 minutes after the oral glucose challenge. This outcome measure was analyzed for a subset of participants in the US and Mexico only.|Baseline and Week 80|Week 32 Evaluable Population with LOCF. Only evaluable participants, defined as participants from US and Mexico sites with a value at baseline and at the specified visit, were analyzed.||ratio||Standard Error|Mean
729035|NCT00386100|Secondary|Percent Change From Baseline in in HOMA-S and HOMA-B to Week 80 (US and Mexico Subset of Participants)|Blood was taken for measurement of homeostasis model assessment for insulin sensitivity (HOMA-S) and beta-cell function (HOMA-B). Percent change from baseline at Week 80 was based on log transformed data. This outcome measure was analyzed for a subset of participants in the US and Mexico only. GM, geometric mean; SE, standard error.|Baseline and Week 80|Week 32 Evaluable Population with LOCF for US and Mexico subset. Only evaluable participants, defined as participants with a value at baseline and at the specified visit for the parameter of interest, were analyzed.||percent change|||Number
729036|NCT00386100|Secondary|Change in C-peptide From Baseline at Week 80 (US and Mexico Subset of Participants)|Blood was taken for C-peptide measurements. Change from baseline was calculated as the Week 80 value minus the baseline value with LOCF from Week 32 for withdrawn participants or missing values. This outcome measure was analyzed for a subset of participants in the US and Mexico only.|Baseline and Week 80|Week 32 Evaluable Population with LOCF for US and Mexico subset. Only evaluable participants, defined as participants with a value at baseline and at the specified visit for the parameter of interest, were analyzed.||mmol/l||Standard Error|Mean
729037|NCT00386100|Secondary|Change in Fasting Insulin From Baseline at Week 80 (US and Mexico Subset of Participants)|Blood was taken for fasting insulin measurements. Change from baseline was calculated as the Week 80 value minus the baseline value, with LOCF from Week 32 for withdrawn participants or missing values. This outcome measure was analyzed for a subset of participants in the US and Mexico only.|Baseline and Week 80|Week 32 Evaluable Population with LOCF for US and Mexico subset. Only evaluable participants, defined as participants with a value at baseline and at the specified visit for the parameter of interest, were analyzed.||picomoles per Liter (pmol/l)||Standard Error|Mean
729038|NCT00386100|Secondary|Percent Change in Free Fatty Acids (FFA) From Baseline at Week 80 (US and Mexico Subset of Participants).|Blood was taken for measurement of FFA. Percent change from baseline at Week 80 was based on log transformed data. This outcome measure was analyzed for a subset of participants in the US and Mexico only.|Baseline and Week 80|Week 32 Evaluable Population with LOCF for US and Mexico subset. Only evaluable participants, defined as participants with a value at baseline and at the specified visit for the parameter of interest, were analyzed.||percent change|||Number
729039|NCT00386100|Secondary|Percent Change From Baseline in C-reactive Protein (CRP) at Week 80 (US and Mexico Subset of Participants)|Blood was taken for measurement of CRP. Percent change from baseline at Week 80 was based on log transformed data. This outcome measure was analyzed for a subset of participants in the US and Mexico only.|Baseline and Week 80|Week 32 Evaluable Population with LOCF for US and Mexico subset. Only evaluable participants, defined as the number of participants with a value at baseline and at the specified visit for the parameter of interest, were analyzed.||percent change|||Number
729040|NCT00386100|Secondary|Percent Change From Baseline in Adiponectin at Week 80 (United States [US] and Mexico Subset of Participants )|Blood was taken for measurement of adiponectin. Percent change from baseline at Week 80 was based on log transformed data. This outcome measure was analyzed for a subset of participants in the US and Mexico only.|Baseline and Week 80|Week 32 Evaluable Population with LOCF for US and Mexico subset. Only evaluable participants, defined as the number of participants with a value at baseline and at the specified visit for the parameter of interest, were analyzed.||percent change|||Number
729041|NCT00386100|Secondary|Percent Change From Baseline in Total Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Triglycerides at Week 80|Blood was taken for measurement of total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides. Percent change from baseline at Week 80 was based on log transformed data. Geometric mean, GM; standard error, SE. n is the number of evaluable participants, which is the number of participants with a value at baseline and at the specified visit for the parameter of interest.|Baseline and Week 80|Week 32 evaluable population with LOCF from Week 32. n is the number of evaluable participants, which is defined as the number of participants with a value at baseline and at the specified visit for the parameter of interest.||percent change|||Number
729379|NCT00390182|Other Pre-specified|Percentage of Participants With Distant Mestastases - Liver|Patients with distant mestastases to the liver|Participants were followed for an average of 8 years|||percentage of participants||95% Confidence Interval|Number
729042|NCT00386100|Secondary|Number of Participants Achieving Treatment Failure|Treatment failure was defined as an HbA1c level >= 7% after Week 32 or withdrawal due to insufficient therapeutic effect (ITE) at any time.|Randomization to treatment failure (up to Week 80)|ITT Population. Only evaluable participants, defined as the number of subjects with a baseline and at least one post baseline assessment, were analyzed. Last observation carried forward (LOCF) was not used for this analysis||participants|||Number
729043|NCT00386100|Secondary|Number of Participants Achieving FPG <=6 mmol/L (110 mg/dL) and <=7 mmol/L (126 mg/dL) at Week 80|Blood was taken for serum FPG measurements. FPG responders were described as participants having achieved FPG <=6 mmol/L (110 mg/dL) and <7 mmol/L (126 mg/dL) Hb1AC at Week 80 with LOCF from Week 32.|Week 80|Week 32 Evaluable Population with LOCF. Only evaluable participants, defined as participants with a value at baseline and at the specified visit for the parameter of interest, were analyzed.||participants|||Number
729044|NCT00386100|Secondary|Change From Baseline in FPG at Week 80|Blood was taken for serum FPG measurements. Change from baseline was calculated as the Week 80 value minus the baseline value with LOCF from Week 32 for withdrawn participants or missing values.|Baseline and Week 80|Week 32 Evaluable Population with LOCF. Only evaluable participants, defined as participants with a value at baseline and at the specified visit for the parameter of interest, were analyzed.||mmol/l||Standard Deviation|Mean
729045|NCT00386100|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline at Week 80|Blood was taken for serum FPG measurements. Change from baseline was calculated as the Week 80 value minus the baseline value.|Baseline and Week 80|ITT Population. Only evaluable participants, defined as the number of participants with a baseline and at least one post baseline assessment, were analyzed. Last observation carried forward (LOCF) was not used for this analysis.||millimoles per Liter (mmol/l)||Standard Error|Mean
729046|NCT00386100|Secondary|Number of Participants Achieving HbA1c <=6.5% and <7% at Week 80|Blood was taken for serum Hb1AC measurements. Hb1AC responders were described as participants having achieved Hb1AC <=6% and <7% at Week 80 with LOCF from Week 32.|Week 80|Week 32 Evaluable Population with LOCF. Only evaluable participants, defined as participants with a value at baseline and at the specified visit for the parameter of interest, were analyzed.||participants|||Number
729047|NCT00386100|Primary|Change From Baseline in HbA1c at Week 80|Blood was taken for serum HbA1c measurements. Change from baseline was calculated as the Week 80 value minus the baseline value. Last observation carried forward (LOCF) was not used for this analysis.|Baseline and Week 80|Intent-to-Treat (ITT) Population: all participants who were randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value. Only evaluable participants, defined as the number of participants with a baseline and at least one post baseline assessment, were analyzed.||percent change||Standard Error|Mean
729048|NCT00386100|Secondary|Mean Change From Baseline in HbA1c at Week 80|Blood was taken for serum Hb1AC measurements. Change from baseline was calculated as the Week 80 value minus the baseline value, with LOCF from Week 32 for withdrawn participants or missing values.|Baseline and Week 80|Week 32 Evaluable Population with LOCF: a subset of the ITT Population with LOCF starting at Week 32. Only participants with assessment(s) at Week 32 or later were included in this population. Only evaluable participants, defined as participants with a value at baseline and at the specified visit for the parameter of interest, were analyzed.||percent change||Standard Deviation|Mean
729049|NCT00386152|Secondary|Number of Patients (Hb >= 11 g/dL) During Study.||up to 16 weeks|modified intention-to-treat (mITT) population that includes the subjects who were randomized, received at least one dose of study medication, and had transfusion-unrelated Hb values obtained at baseline and at least one post baseline visit||participants|||Number
729050|NCT00386152|Secondary|Time to Achieve Hb >= 11 g/dL During Study||up to 16 weeks|modified intention-to-treat (mITT) population that includes the subjects who were randomized, received at least one dose of study medication, and had transfusion-unrelated Hb values obtained at baseline and at least one post baseline visit||days||95% Confidence Interval|Median
729051|NCT00386152|Primary|Hemoglobin (Hb) Change From Baseline to Study Week 7|Baseline Hb was the Hb value that was consistent with the inclusion criteria and which was obtained within 72 hours of the first dose of study medication|Baseline (Week 1) and Week 7|per-protocol (PP) population that includes a subset of the modified intent-to-treat (mITT) population with subjects who were randomized and received at least one dose of study medication, had transfusion-unrelated Hb values obtained at both baseline and Week 7, met inclusion and exclusion criteria, and had no major protocol violations up to Week 7||g/dL||Standard Deviation|Mean
729052|NCT00386152|Secondary|Number of Patients Receiving at Least 1 Packed Red Blood Cell (PRBC) Transfusion During Study||up to 16 weeks|modified intention-to-treat (mITT) population that includes the subjects who were randomized, received at least one dose of study medication, and had transfusion-unrelated Hb values obtained at baseline and at least one post baseline visit||participants|||Number
729053|NCT00386243|Primary|Brief Pain Inventory (Interference)|"This is an 7-item measure that provides scores for pain-related functional impairment. The seven (7) pain interference items are rated on a simple numeric rating scale from 0-10. On the scale 0 represents no interference and 10 is completely interferes. The pain interference score is achieved by taking the total of all seven (7) scores and dividing it by the number of items (7)."|Baseline and 9 months|||units on a scale||Standard Deviation|Mean
729054|NCT00386243|Secondary|Pain Self-efficacy (Arthritis Self-efficacy Scale)||at baseline, 3, 6, and 9 months||||||
729055|NCT00386243|Secondary|Generic HRQL (SF-12)||at baseline, 3, 6, and 9 months||||||
729056|NCT00386243|Secondary|Work Function (Work and Health Interview)||at baseline, 3, 6, and 9 months||||||
729057|NCT00386243|Secondary|Clinical Response (Global Rating of Change)||at baseline, 3, 6, and 9 months||||||
729058|NCT00386243|Secondary|Psychological Distress (PHQ-9, MCS Score of SF-12, PRIME-MD Anxiety, PTSD Checklist (PCL-17))||at baseline, 3, 6, and 9 months||||||
729059|NCT00386243|Primary|Roland-Morris Disability Questionnaire|This is a 24-item pain specific disability questionnaire consisting of 24 questions which are related specifically to physical functions that are likely to be affected by back pain. The questionnaire is scored by adding up the number of items checked by the subject (0-24 range). Greater levels of disability are reflected by higher numbers.|at baseline and 9 months|||scores on a scale||Standard Deviation|Mean
729816|NCT00383331|Secondary|Overall Survival|Survival time is defined as the time from date of randomization to death due to any cause.|baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up|||months||95% Confidence Interval|Median
729060|NCT00386256|Primary|HB/Phone Adherence|An 11-week text messaging or phone adherence rate was calculated by dividing the number of response days via the HB or phone divided by 77 days and multiplied by 100. This first calculation estimated the text messaging or phone adherence rate for the full intervention period regardless of participant dropout. Eleven weeks rather than 12 weeks was used in the denominator because subjects received their HB units some time during the first week of study enrollment and may have missed some days during this first week.|Monthly over 3 months|||percentage of days adhered||Standard Deviation|Mean
729061|NCT00386256|Primary|Exercise Adherence|An 11-week exercise adherence rate was calculated by dividing the total number of days that the participant reported exercising by 77 days and multiplying by 100. This first calculation estimated the exercise adherence rate for the full intervention period regardless of participant dropout. Eleven weeks rather than 12 weeks was used in the denominator because subjects received their HB units some time during the first week of study enrollment and may have missed some days during this first week.|at monthly intervals, for 3-months|||percentage of days adhered||Standard Deviation|Mean
729062|NCT00386308|Primary|Mean Reduction From Baseline in Menstrual Blood Loss (MBL)|reduction of menstrual blood loss in mL|Baseline MBL over 6 menstrual cycles|modified intent to treat population||mL||Standard Deviation|Least Squares Mean
729063|NCT00386308|Secondary|Responder Analysis - Reduction in Large Stains|Percentage of subjects who experienced a reduction from baseline in the frequency of large stains|Reduction from Baseline over 6 menstrual cycles|modified intent to treat population (reflects those subjects who met the criteria for the primary efficacy analysis)||percentage of subjects|||Number
729064|NCT00386308|Secondary|Patient Reported Outcome Measure of Limitations in Physical Activities Associated With Heavy Menstrual Bleeding|A positive unit change mean relects an improvement from baseline. Patient reported outcome scores had the following response categories: 1=not limited at all; 2=slightly limited; 3=moderately limited; 4=quite a bit limited; and 5=extremely limited|Change from Baseline scores over 6 menstrual cycles|modified intent to treat population (reflects those subjects who met the criteria for the primary efficacy analysis)||units on a scale||Standard Deviation|Least Squares Mean
729065|NCT00386308|Secondary|Patient Reported Outcome Measure of Limitations in Social or Leisure Activities Associated With Heavy Menstrual Bleeding|A positive unit change mean relects an improvement from baseline. Patient reported outcome scores had the following response categories: 1=not limited at all; 2=slightly limited; 3=moderately limited; 4=quite a bit limited; and 5=extremely limited|Change from Baseline scores over 6 menstrual cycles|modified intent to treat population (reflects those subjects who met the criteria for the primary efficacy analysis)||units on a scale||Standard Deviation|Least Squares Mean
729066|NCT00386334|Secondary|Mean Sheehan Disability Total Scores|Sheehan Disability Scale Total Score (range 0-30) measures subject's level of disability; includes work/school, social life, family life/home responsibilities, days lost, days underproductive; higher scores represent higher degree of disability/impairment. Mean values reported: baseline, double-blind(weeks 6,12)& follow-up(weeks 14,16).|Weeks 0,6,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.||units on a scale||Standard Deviation|Mean
729067|NCT00386334|Secondary|Mean Change From Baseline in the Sheehan Disability Scale Total Score.|Sheehan Disability Scale Total Score (range 0-30)measures subject's level of disability & includes: work/school, social life, family life/home responsibilities, days lost &days underproductive; higher scores represent higher degree of disability/impairment. Change is calculated as time point value minus baseline value.|Baseline (week 0), Weeks 6,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.||units on a scale||Standard Deviation|Mean
729068|NCT00386334|Secondary|Mean Mental Component Summary of the Short Form-36 Scale Scores|This scale measures subject's perception of their physical health, where normal mean for general US population is 50. Scores above/below 50 represent better/worse than general US population. Change calculated: time point value minus baseline value. Mean values: baseline(week0), double-blind phase(weeks 6,12)& non-drug treatment follow-up(week 16).|Weeks 0,6,12,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.||units on a scale||Standard Deviation|Mean
729069|NCT00386334|Secondary|Mean Change From Baseline in Mental Component Summary of the Short Form-36 Scale Scores|Mental component summary of Short Form-36 Scale measures subject's perception of their physical health, where the normal mean for general US population is 50. Scores above/below 50 represent better than/worse than the general US population. Higher scores represent better outcomes. Change is calculated as time point value minus baseline value.|Baseline (week 0), Weeks 6,12,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.||units on a scale||Standard Deviation|Mean
729070|NCT00386334|Secondary|Mean Physical Component Summary of the Short Form-36 Scale Scores.|This scale measures subject's perception of their physical health, where the normal mean for general US population is 50.Scores above/below 50 represent better/worse than general US population. Change calculated as time point value minus baseline value: baseline(week0), double-blind (weeks 6,12)and non-drug treatment follow-up(week16).|Weeks 0,6,12,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.||units on a scale||Standard Deviation|Mean
729071|NCT00386334|Secondary|Mean Change From Baseline in Physical Component Summary of the Short Form-36 Scale|Physical component summary of Short Form-36 Scale measures subject's perception of their physical health, where the normal mean for general US population is 50.Scores above/below 50 represent better than/worse than the general US population. Higher scores represent better outcomes. Change is calculated as time point value minus baseline value.|Baseline (week 0), Weeks 6, 12, 16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.||units on a scale||Standard Deviation|Mean
729225|NCT00386880|Primary|Correlation Between Phonophobia (Sound Sensitivity) and Allodynia (Skin Sensitivity) in Subjects With Episodic Migraine|Measurement of phonophobia: determine sound aversion threshold (SAT), measured in dB during a migraine attack in subjects with and in subjects without allodynia.|Subjects with or without allodynia return during a migraine attack and are tested for Phonophobia.|||participants|||Number
729072|NCT00386334|Secondary|Mean Insomnia Severity Index Total Scores at Various Study Time Points|The Insomnia Severity Index Total Score ranges from 0-28. Lower scores represent better sleep. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).|Weeks 0,3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.||units on a scale||Standard Deviation|Mean
729073|NCT00386334|Secondary|Mean Change From Baseline in Insomnia Severity Index Total Score at Various Study Time Points|Change from baseline in the Insomnia Severity Index Total Score which ranges from 0-28. Lower scores represent better sleep. The change is calculated as time point value minus the baseline value.|Baseline (week 0), Weeks 3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.||units on a scale||Standard Deviation|Mean
729074|NCT00386334|Secondary|Mean Change From Baseline in Insomnia Severity Index Total Score Averaged Over the 12 Week Double Blind Study Period|Change from baseline in the Insomnia Severity Index Total Score which ranges from 0-28. Lower scores represent better sleep. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.|Baseline (week 0), Day 1 (post first dose) - week 12|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.||units on a scale||Standard Deviation|Mean
729075|NCT00386334|Secondary|Mean Total Nap Time Per Week as a Percentage of Total Asleep Time Measured Using Actigraphy at Various Study Time Points|The total time spent napping per week as a percent of the total time asleep for subjects who napped during the baseline period. Mean values reported: baseline(week 0), double-blind phase(weeks 1,4,7,12), single-blind follow-up(week 13), non-drug treatment follow-up(week 15) & average for double-blind phase(average of weeks 1,4,7,12 values).|Week 0,1,4,7,12,13,15|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.||percentage of total asleep time||Standard Deviation|Median
729076|NCT00386334|Secondary|Mean Change From Baseline in Total Nap Time Per Week as a Percentage of Total Asleep Time as Measured by Actigraphy at Various Study Time Points|Change from baseline in total time spent napping per week as a percent of total time asleep for subjects who napped during the baseline period. Change is calculated as time point value minus the baseline value.|Baseline (week 0), Weeks 1,4,7,12,13,15|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.||percentage of total asleep time||Standard Deviation|Mean
729077|NCT00386334|Secondary|Mean Change From Baseline in Total Nap Time Per Week as a Percentage of Total Asleep Time Measured by Actigraphy and Averaged Over the 12 Week Double Blind Study Period.|Change from baseline in the total time spent napping per week as a percent of the total time asleep for subjects who napped during the baseline period. Change is calculated as the average over the double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.|Baseline (week 0), Day 1 (post first dose) - week 12|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.Actigraphy population N=72,69.||percentage of total asleep time||Standard Deviation|Mean
729078|NCT00386334|Secondary|Mean Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points.|The total nap time per week for subjects who napped during the baseline period. Mean values are reported at baseline(week 0), double-blind phase(weeks 1,4,7,12), single-blind follow-up(week 13), non-drug treatment follow-up(week 15), and the average for the double-blind phase(average of weeks 1,4,7,12 values).|Week 0,1,4,7,12,13,15|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.||minutes||Standard Deviation|Mean
729079|NCT00386334|Secondary|Mean Change From Baseline in Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points|Change from baseline in the total nap time per week for subjects who napped during the baseline period. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as time point value minus the baseline value.|Baseline (week 0), Weeks 1,4,7,12,13,15|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.||minutes||Standard Deviation|Mean
729080|NCT00386334|Secondary|Mean Change From Baseline Total Nap Time Per Week Measured by Actigraphy Averaged Over the 12 Week Double Blind Study Period|Change from baseline in the total nap time per week for subjects who napped during the baseline period. Change is calculated as the average over the double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.|Baseline (week 0), Day 1 (post first dose) - week 12|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.Actigraphy population N=72,69.||minutes||Standard Deviation|Mean
729090|NCT00386334|Secondary|Mean Sleep Latency Values Measured Using Actigraphy at Various Study Time Points.|Sleep latency:measurement of time to fall asleep. Values are for subset who wore an actigraph wrist monitor which monitors rest and activity cycles; sleep parameters calculated by Central Reader.|Weeks 0,1,4,7,12,13,15|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. Mean values reported:baseline(week0), double-blind (weeks 1,4,7,12), single-blind follow-up(week13), non-drug treatment follow-up(week15) & average for double-blind (average of weeks 1,4,7,12 values). Last Observation Carried Forward.||minutes||Standard Deviation|Mean
729081|NCT00386334|Secondary|Mean Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points|The number of naps per week for subjects who napped during the baseline period. Mean values are reported at baseline(week 0), double-blind phase(weeks 1,4,7,12), single-blind follow-up(week 13), non-drug treatment follow-up(week 15), and the average for the double-blind phase(average of weeks 1,4,7,12 values).|Week 0,1,4,7,12,13,15|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.||number of naps||Standard Deviation|Mean
729082|NCT00386334|Secondary|Mean Change From Baseline in the Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points|Change from baseline in the number of naps per week for subjects who napped during the baseline period. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as time point value minus the baseline value.|Baseline (week 0), Weeks 1,4,7,12,13,15|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.||number of naps||Standard Deviation|Mean
729083|NCT00386334|Secondary|Mean Change From Baseline in Number of Naps Per Week Measured Using Actigraphy Averaged Over the 12 Week Double Blind Study Period|Change from baseline in the number of naps per week for subjects who napped during the baseline period. Change is calculated as the average over the double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.|Baseline (week 0), Day 1 (post first dose) - week 12|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.Actigraphy population N=72,69.||number of naps||Standard Deviation|Mean
729084|NCT00386334|Secondary|Mean Number of Awakenings Measured Using Actigraphy at Various Study Time Points|Number of awakenings refers to the number of times a subject awakens between first sleep onset to final awakening. Mean values are reported at baseline(week 0), double-blind phase(weeks 1,4,7,12), single-blind follow-up(week 13), non-drug treatment follow-up(week 15), and the average for the double-blind phase(average of weeks 1,4,7,12 values).|Weeks 0,1,4,7,12,13,15|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.||number of awakenings||Standard Deviation|Mean
729085|NCT00386334|Secondary|Mean Change From Baseline in the Number of Awakenings Measured Using Actigraphy at Various Study Time Points.|Number of awakenings refers to the number of times a subject awakens between first sleep onset to final awakening. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as time point value minus the baseline value.|Baseline (week 0), Weeks 1,4,7,12,13,15|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.||number of awakenings||Standard Deviation|Mean
729086|NCT00386334|Secondary|Mean Change From Baseline in Number of Awakenings Using Actigraphy Averaged Over the 12 Week Double Blind Study Period|Number of awakenings refers to the number of times a subject awakens between first sleep onset to final awakening. Change is calculated as average over double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.|Baseline (week 0), Day 1 (post first dose) - week 12|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.Actigraphy population N=72,69.||number of awakenings||Standard Deviation|Mean
729087|NCT00386334|Secondary|Mean Values for Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points|Wake time after sleep onset is time spent awake from sleep onset to final awakening. Mean values reported: baseline(week 0), double-blind phase(weeks 1,4,7,12), single-blind follow-up(week 13), non-drug treatment follow-up(week 15) & average for double-blind phase(average of weeks 1,4,7,12 values).|weeks 0,1,4,7,12,13,15|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.||minutes||Standard Deviation|Mean
729088|NCT00386334|Secondary|Mean Change From Baseline in Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points|Wake time after sleep onset is the time spent awake from sleep onset to final awakening. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as time point value minus the baseline value.|Baseline (week 0), Weeks 1,4,7,12,13,15|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.||minutes||Standard Deviation|Mean
729089|NCT00386334|Secondary|Mean Change From Baseline in Wake Time After Sleep Onset (WASO) Measured by Actigraphy Averaged Over the 12 Week Double Blind Study Period|Wake time after sleep onset is the time spent awake from sleep onset to final awakening. Change is calculated as average over double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.|Baseline (week 0), Day 1 (post first dose) - week 12|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.Actigraphy population N=72,69.||minutes||Standard Deviation|Mean
730335|NCT00387647|Secondary|Number of Participants With Adverse Events|Safety and tolerability of treatment as measured by NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0|48 months|All participants||participants|||Number
729091|NCT00386334|Secondary|Mean Change From Baseline in Sleep Latency Measured Using Actigraphy at Various Study Time Points|Sleep latency is a measurement of the time it takes to fall asleep. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as time point value minus the baseline value.|Baseline (week 0), Weeks 1,4,7,12,13,15|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.||minutes||Standard Deviation|Mean
729092|NCT00386334|Secondary|Mean Change From Baseline in Sleep Latency Measured Using Actigraphy Averaged Over the 12 Week Double Blind Study Period|Sleep latency is the time it takes to fall asleep. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as the average over the double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.|Baseline (week 0), Day 1 (post first dose) - week 12|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.Actigraphy population N=72,69.||minutes||Standard Deviation|Mean
729093|NCT00386334|Secondary|Mean Total Sleep Time Measured by Actigraphy at Various Study Time Points|Total sleep time for subset who wore actigraph wrist monitor which monitors rest and activity cycles, sleep parameters calculated by Central Reader. Mean values reported:baseline(week0), double-blind(weeks1,4,7,12), single-blind follow-up(week13), non-drug follow-up(week15) & average for double-blind(average of weeks1,4,7,12 values).|Weeks 0,1,4,7,12,13,15|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.||minutes||Standard Deviation|Mean
729094|NCT00386334|Secondary|Mean Change From Baseline in Total Sleep Time Measured by Actigraphy at Various Study Time Points|Change from baseline in total sleep time for the subset population who wore an actigraph wrist monitor. The actigraph monitors rest and activity cycles; the resultant data had sleep parameters calculated by a Central Reader. The change is calculated as time point value minus the baseline value.|Baseline (week 0), Weeks 1,4,7,12,13,15|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.||minutes||Standard Deviation|Mean
729095|NCT00386334|Secondary|Mean Change From Baseline in Total Sleep Time Measured by Actigraphy Averaged Over the 12 Week Double Blind Study Period|Participants who wore an actigraph wrist monitor, which monitors rest and activity cycles are included; the resultant data had total sleep time calculated by a Central Reader. The change is calculated as the average over the double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.|Baseline (week 0), Day 1 (post first dose) - week 12|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.Actigraphy population N=72,69.||minutes||Standard Deviation|Mean
729096|NCT00386334|Secondary|Mean Subject-Reported Total Nap Time Per Week Stated as a Percentage of the Total Asleep Time at Various Study Time Points|Total time spent napping per week stated as a percentage of total time asleep for subjects who napped during baseline period. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week14), non-drug treatment follow-up(week 16), & average for double-blind phase(average of weeks 3,6,9,12 values).|Weeks 0,3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward.||percentage of total asleep time||Standard Deviation|Median
729097|NCT00386334|Secondary|Mean Change From Baseline in Subject-Reported Total Nap Time Stated as a Percentage of the Total Asleep Time at Various Study Time Points|Change from baseline in the total time spent napping per week stated as a percentage of the total time asleep for subjects who napped during the baseline period. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.|Baseline (week 0), Weeks 3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward.||percentage of total asleep time||Standard Deviation|Mean
729098|NCT00386334|Secondary|Mean Change From Baseline in Subject-Reported Total Nap Time Per Week as a Percent of Total Asleep Time Averaged Over the 12 Week Double Blind Study Period|Change from baseline in the total time spent napping per week stated as a percentage of the total time asleep for subjects who napped during the baseline period. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.|Baseline (week 0), Day 1 (post first dose) - week 12|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.||percentage of total asleep time||Standard Deviation|Mean
729099|NCT00386334|Secondary|Mean Subject-Reported Total Nap Time at Various Study Time Points|The total time (minutes) spent napping per week for subjects who napped during the baseline period. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).|Weeks 0,3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward.||minutes||Standard Deviation|Mean
729267|NCT00388947|Secondary|Prolapse Efficacy Success Rate|Success was defined as either (1) Baden-Walker grade 0 or 1 or (2) (Pelvic Organ Prolapse Quantification System) POP-Q stage 0 or 1. If a site reported both measurements, then the POP-Q score was used.|24 months|Patients returning for a visit between 19-24 months post-procedure.||percentage of participants||95% Confidence Interval|Number
729100|NCT00386334|Secondary|Mean Change From Baseline in Subject-Reported Total Nap Time Per Week at Various Study Time Points.|Change from baseline in the total time (minutes) spent napping per week for subjects who napped during the baseline period. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.|Baseline (week 0), Weeks 3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward.||minutes||Standard Deviation|Mean
729101|NCT00386334|Secondary|Mean Change in Subject-Reported Total Nap Time Per Week Averaged Over the 12 Week Double Blind Study Period|Change from baseline in the total time (minutes) spent napping per week for subjects who napped during the baseline period. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.|Baseline (week 0), Day 1 (post first dose) - week 12|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.||minutes||Standard Deviation|Mean
729102|NCT00386334|Secondary|Mean Subject-Reported Number of Naps Each Week at Various Study Time Points.|The mean number of naps per week for subjects who napped during the baseline period. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).|Weeks 0,3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward.||number of naps||Standard Deviation|Mean
729103|NCT00386334|Secondary|Mean Change From Baseline In Subject-Reported Counts of Number of Naps Per Week at Various Study Time Points|Change from baseline in the number of naps per week for subjects who napped during the baseline period. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.|Baseline (week 0), Weeks 3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward.||number of naps||Standard Deviation|Mean
729104|NCT00386334|Secondary|Mean Change From Baseline in Subject-Reported Counts of Number of Naps Per Week Averaged Over the 12 Week Double Blind Study Period|Change from baseline in the number of naps per week for subjects who napped during the baseline period. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.|Baseline (week 0), Day 1 (post first dose)- week 12|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.||number of naps||Standard Deviation|Mean
729105|NCT00386334|Secondary|Mean Subject-reported Physical Well-Being at Various Study Time Points|Physical well-being was rated by study participants on a scale of 0-10, with higher scores representing better well-being. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), & average for double-blind phase(average of weeks 3,6,9,12 values).|Weeks 0,3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.||units on a scale||Standard Deviation|Mean
729106|NCT00386334|Secondary|Mean Change From Baseline in Subject-reported Physical Well-being at Various Study Time Points.|Physical well-being was rated by study participants on a scale of 0-10, with higher scores representing better well-being. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.|Baseline (week 0), Weeks 3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.||units on a scale||Standard Deviation|Mean
729107|NCT00386334|Secondary|Mean Change From Baseline in Subject-reported Physical Well-Being Averaged Over the 12 Week Double Blind Study Period|Physical well-being was rated by study participants on a scale of 0-10, with higher scores representing better well-being. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.|Baseline (week 0), Day 1 (post first dose) - week 12|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.||units on a scale||Standard Deviation|Mean
729108|NCT00386334|Secondary|Mean Subject-reported Ability to Concentrate at Various Study Time Points|Ability to concentrate was rated by study participants on a scale of 0-10, with higher scores representing better concentration. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16) & average for the double-blind phase(average of weeks 3,6,9,12 values).|Weeks 0,3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.||units on a scale||Standard Deviation|Mean
729109|NCT00386334|Secondary|Mean Change From Baseline in Subject-reported Ability to Concentrate at Various Study Time Points.|Ability to concentrate was rated by study participants on a scale of 0-10, with higher scores representing better concentration. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.|Baseline (week 0), Weeks 3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.||units on a scale||Standard Deviation|Mean
729110|NCT00386334|Secondary|Mean Change From Baseline in Subject-reported Ability to Concentrate Averaged Over the 12 Week Double Blind Study Period.|Ability to concentrate was rated by study participants on a scale of 0-10, with higher scores representing better concentration. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.|Baseliine (week 0), Day 1 (post first dose) - week 12|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.||units on a scale||Standard Deviation|Mean
729111|NCT00386334|Secondary|Mean Subject-reported Ability to Function at Various Study Time Points|Ability to function was rated by study participants on a scale of 0-10, with higher scores representing better ability to function. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16) & average for double-blind phase(average of weeks 3,6,9,12 values).|Weeks 0,3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.||units on a scale||Standard Deviation|Mean
729112|NCT00386334|Secondary|Mean Change From Baseline in Subject-reported Ability to Function at Various Study Time Points|Ability to function was rated by study participants on a scale of 0-10, with higher scores representing better ability to function. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.|Baseline (week 0), Weeks 3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.||units on a scale||Standard Deviation|Mean
729113|NCT00386334|Secondary|Mean Change From Baseline in Subject-Reported Ability to Function Averaged Over the 12 Week Double Blind Period|Ability to function was rated by study participants on a scale of 0-10, with higher scores representing better ability to function. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.|Baseline (week 0), Day 1 (post first dose) - week 12|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.||units on a scale||Standard Deviation|Mean
729114|NCT00386334|Secondary|Mean Subject-reported Daytime Alertness at Various Study Time Points.|Daytime alertness was rated by study participants on a scale of 0-10, with higher scores representing better alertness. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).|Weeks 0,3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.||units on a scale||Standard Deviation|Mean
729115|NCT00386334|Secondary|Mean Change From Baseline in Subject-reported Daytime Alertness at Various Study Time Points|Daytime alertness was rated by study participants on a scale of 0-10, with higher scores representing better alertness. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.|Baseline (week 0), Weeks 3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.||units on a scale||Standard Deviation|Mean
729116|NCT00386334|Secondary|Mean Change in Subject-reported Daytime Alertness Averaged Over the 12 Week Double Blind Study Period|Daytime alertness was rated by study participants on a scale of 0-10, with higher scores representing better alertness. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.|Baseline (week 0), Day 1 (post first dose) - week 12|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.||units on a scale||Standard Deviation|Mean
729117|NCT00386334|Secondary|Mean Subject-reported Depth of Sleep at Various Study Time Points|Depth of sleep was reported by study participants using a scale from 0-10, with higher scores representing better sleep. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).|weeks 0,3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.||units on a scale||Standard Deviation|Mean
729118|NCT00386334|Secondary|Mean Change From Baseline in Subject-reported Depth of Sleep at Various Study Time Points|Depth of sleep was reported by study participants using a scale from 0-10, with higher scores representing better sleep. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.|Baseline (week 0), Weeks 3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.||units on a scale||Standard Deviation|Mean
729119|NCT00386334|Secondary|Mean Change From Baseline in Subject-Reported Depth of Sleep for the Average Reported During the Double-blind Period.|Depth of sleep was reported by study participants using a scale from 0-10, with higher scores representing better sleep. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.|Baseline (week 0), Day 1 (post first dose) - week 12|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.||units on a scale||Standard Deviation|Mean
729120|NCT00386334|Secondary|Mean Ratings of Subject-reported Quality of Sleep at Various Study Time Points|Quality of sleep was rated by participants on a scale of 0-10, with higher scores representing better quality sleep. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).|weeks 0,3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.||units on a scale||Standard Deviation|Mean
729121|NCT00386334|Secondary|Mean Change From Baseline in Subject-reported Quality of Sleep at Various Study Time Points.|Sleep quality was rated by subjects on a scale from 0-10, with higher scores representing better quality sleep. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.|Baseline (week 0), Weeks 3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.||units on a scale||Standard Deviation|Mean
729122|NCT00386334|Secondary|Mean Change From Baseline in Subject-reported Quality of Sleep Averaged Over the 12 Week Double Blind Study Period|Quality of sleep was rated by participants on a scale of 0-10, with higher scores representing better quality sleep. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.|Baseline (week 0), Day 1 (post first dose) - Week12|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.||units on a scale||Standard Deviation|Mean
729123|NCT00386334|Secondary|Mean Number of Awakenings (Subject-reported) at Various Study Time Points|Number of awakenings is number of times a subject wakes up between initial onset of sleep and final awakening. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).|Weeks 0,3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.||number of awakenings||Standard Deviation|Mean
729124|NCT00386334|Secondary|Mean Change From Baseline in the Number of Subject-reported Awakenings at Various Study Time Points.|The number of awakenings refers to the number of times a subject wakes up between the initial onset of sleep and the final awakening. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.|Baseline (week 0), Weeks 3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.||number of awakenings||Standard Deviation|Mean
729125|NCT00386334|Secondary|Mean Change From Baseline in Subject-reported Number of Awakenings Averaged Over the 12 Week Double Blind Study Period.|The number of awakenings is the number of times a subject wakes up between the initial onset of sleep and the final awakening. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.|Baseline (week 0), Day 1 (post first dose) - Week12|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.||number of awakenings||Standard Deviation|Mean
729126|NCT00386334|Secondary|Mean Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points|Wake time after sleep onset is the time spent awake from sleep onset to final awakening. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the entire double-blind phase(average of weeks 3,6,9,12 values).|Weeks 0,3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.||minutes||Standard Deviation|Mean
729127|NCT00386334|Secondary|Mean Change From Baseline in Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points.|Wake time after sleep onset is the time spent awake from sleep onset to final awakening. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.|Baseline (week 0), weeks 3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.||minutes||Standard Deviation|Mean
729128|NCT00386334|Secondary|Mean Change From Baseline in Subject-reported Wake Time After Sleep Onset (WASO) Averaged Over the 12 Week Double-blind Study Period.|Wake time after sleep onset (WASO) is the time spent awake from sleep onset to final awakening. The difference between WASO at baseline and the average WASO over the double blind period(average of post-dose values from weeks 3,6,9,12). The change is calculated as the average over the double blind period minus the baseline value.|Baseline (week 0), Day 1 (post first dose) -week 12|Intent to treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last observation carried forward (LOCF). Number of participants in each arm 194, 194.||minutes||Standard Deviation|Mean
729129|NCT00386334|Secondary|Mean Subject-reported Sleep Latency Reported at Various Study Time Points.|Sleep latency answers the question: How long did it take you to fall asleep last night? Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the entire double-blind phase(average of weeks 3,6,9,12 values).|Weeks 0,3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.||minutes||Standard Deviation|Mean
729130|NCT00386334|Secondary|Mean Change From Baseline in Subject-reported Sleep Latency at Various Study Time Points|Sleep latency answers the question: How long did it take you to fall asleep last night? The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.|Baseline (week 0), Weeks 3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.||minutes||Standard Deviation|Mean
729131|NCT00386334|Secondary|Mean Change From Baseline in Subject-reported Sleep Latency (SL) Averaged Over the 12 Week Double Blind Period.|Sleep latency answers how long it takes to fall asleep. The difference between the sleep latency at baseline and the average sleep latency over the double blind period(average of post-dose values from weeks 3,6,9,12) reported by the participant. The change is calculated as the average over the double blind period minus the baseline value.|Baseline (week 0), Day 1 (post first dose) - Week12|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.||minutes||Standard Deviation|Mean
729132|NCT00386334|Secondary|Mean Subject-reported Total Sleep Time in Minutes at Various Study Time Points.|The mean total minutes asleep each night at different time points: baseline(week 0), double-blind phase(weeks 3,6,9,12), the single-blind follow-up(week 14),the non-drug treatment follow-up(week 16), and the double-blind average(average of weeks 3,6,9,12 values).|Weeks 0, 3, 6, 9, 12, 14, 16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.||minutes||Standard Deviation|Mean
729133|NCT00386334|Secondary|Mean Change From Baseline in Subject-reported Total Sleep Time at Various Study Time Points.|The difference between the total sleep time at baseline and at different time points in the double-blind period (weeks 3,6,9,12), the single-blind follow-up (week 14) and the non-drug treatment follow-up (week 16). The change is calculated as the time point value minus the baseline value.|Weeks 0, 3, 6, 9, 12, 14, 16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Change calculated as the post-dose measure minus the baseline measure.||minutes||Standard Deviation|Mean
729134|NCT00386334|Primary|Mean Change From Baseline in Subject-Reported Total Sleep Time (TST) Averaged Over the 12 Week Double Blind Study Period.|The difference between the total sleep time at baseline and the average total sleep time over the double blind period(average of post-dose values from weeks 3,6,9,12) reported by the participant. The change is calculated as the average over the double blind period minus the baseline value.|Baseline (week 0), Day 1 (post first dose)-12 weeks|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Change calculated as the post-dose measure minus the baseline measure. Number of participants in each arm 194, 194.||minutes||Standard Deviation|Mean
729135|NCT00386360|Secondary|Height, Percent Change From Baseline to Month 12||Baseline and Month 12|PP - all patients in ITT population who had no major protocol violations.||Percent Change||95% Confidence Interval|Least Squares Mean
729136|NCT00386360|Secondary|Procollagen Type 1 N-Propeptide, Percent Change From Baseline to Month 12|Electrochemiluminescence assay method by central lab|Baseline and Month 12|PP - all patients in ITT population who had no major protocol violations.||Percent Change||95% Confidence Interval|Least Squares Mean
729137|NCT00386360|Secondary|Type I Collagen C-Telopeptides, Serum, Percent Change From Baseline to Month 12|ELISA / enzyme-linked immunosorbent assay method by central lab|Baseline and Month 12|PP - all patients in ITT population who had no major protocol violations.||Percent Change||95% Confidence Interval|Least Squares Mean
729138|NCT00386360|Secondary|Greater Trochanter BMD, Percent Change From Baseline to Month 12||Baseline and Month 12|PP - all patients in ITT population who had no major protocol violations.||Percent Change||95% Confidence Interval|Least Squares Mean
729139|NCT00386360|Secondary|Femoral Neck BMD, Percent Change From Baseline to Month 12||Baseline and Month 12|PP - all patients in ITT population who had no major protocol violations.||Percent Change||95% Confidence Interval|Least Squares Mean
729140|NCT00386360|Secondary|Total Proximal Femur BMD (Bone Mineral Density), Percent Change From Baseline to Month 12||Baseline and Month 12|PP - all patients in ITT population who had no major protocol violations.||Percent Change||95% Confidence Interval|Least Squares Mean
729141|NCT00386360|Secondary|Lumbar Spine BMD, Percent Change From Baseline to Month 12||Baseline and Month 12|PP - all patients in ITT population who had no major protocol violations.||Percent Change||95% Confidence Interval|Least Squares Mean
729142|NCT00386360|Secondary|Trabecular Bone Density at Distal Tibia, Percent Change From Baseline to Month 12||Baseline and Month 12|PP - all patients in ITT population who had no major protocol violations.||Percent Change||95% Confidence Interval|Least Squares Mean
729143|NCT00386360|Secondary|Compact Bone Density at Distal Tibia, Percent Change From Baseline to Month 12||Baseline and Month 12|PP - all patients in ITT population who had no major protocol violations.||Percent Change||95% Confidence Interval|Least Squares Mean
729144|NCT00386360|Secondary|Average Bone Density at Distal Tibia, Percent Change From Baseline to Month 12||Baseline and Month 12|PP - all patients in ITT population who had no major protocol violations.||Percent Change||95% Confidence Interval|Least Squares Mean
729145|NCT00386360|Secondary|Trabecular Bone Density at Distal Radius, Percent Change From Baseline to Month 12||Baseline and Month 12|PP - all patients in ITT population who had no major protocol violations.||Percent Change||95% Confidence Interval|Least Squares Mean
729146|NCT00386360|Secondary|Compact Bone Density at Distal Radius, Percent Change From Baseline to Month 12||Baseline and Month 12|PP - all patients in ITT population who had no major protocol violations.||Percent Change||95% Confidence Interval|Least Squares Mean
729147|NCT00386360|Secondary|Average Bone Density at Distal Radius, Percent Change From Baseline to Month 12||Baseline and Month 12|Per Protocol (PP) Population - all patients in ITT population who had no major protocol violations.||Percent Change||95% Confidence Interval|Least Squares Mean
729148|NCT00386360|Primary|Trabecular Bone Volume to Tissue Volume at Distal Radius, Percent Change From Baseline to Month 12||Baseline and Month 12|Primary Efficacy Population - all patients in ITT population who had no major protocol violations and had an evaluable distal radius BV/TV (trabecular bone volume to tissue volume) at baseline and Month 12.||Percent Change||95% Confidence Interval|Least Squares Mean
729149|NCT00386425|Post-Hoc|Mortality for Moderate Protein C Deficiency by Infusion Duration||28 Days|ITT Population - ITT Switch-No Population, ITT patients who did not answer yes to the switch question.||percent participants deceased|||Number
729150|NCT00386425|Other Pre-specified|Mortality for Severe Protein C Deficiency|Twenty-eight day mortality is the patient's mortality status at the predefined timepoint of 672 hours from the start of study drug infusion. Hospital mortality is the patient's survival status at the end of the hospital stay or study day 90 (if the patient remains in the hospital).|28 Days, up to 90 days|ITT Population - All patients who are randomly assigned to treatment and receive any amount of randomized therapy. ITT patients with severe protein C deficiency. Severe deficiency is defined by the 24-hour local laboratory protein C value reported to the Interactive voice response system (IVRS).||Percentage of participants|||Number
729151|NCT00386425|Secondary|Mortality by Protein C Normalized Versus Not-normalized|Normalization was defined as having 2 consecutive protein C measurements above the lower limit of normal through Study Day 7.|28 days|ITT Population - All patients who are randomly assigned to treatment and receive any amount of randomized therapy||Percentage of participants|||Number
729180|NCT00366899|Primary|Percentage of Participants Reporting Pre-Specified Local Reactions|Local reactions were collected using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.|During the 4-day period after each dose|The safety population included all participants who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.||Percentage of Participants|||Number
729152|NCT00386425|Secondary|Number of Participants With Serious Adverse Events (SAE) and Serious Bleeding Events (SBE) by Time Period|Serious bleeding events (SBE): intracranial hemorrhage, life-threatening or fatal bleed, or bleeding event assessed as an SAE. Patients may have multiple events with onset in different time periods. SAEs include SBEs. The 3 SBEs in Alternative-Moderate Deficiency arm (days 5-8) occurred after completion of study drug infusion. One event (pleural haemorrhage) occurred same day of completion of infusion and 2 events (cerebral haemorrhage, shock haemorrhagic) occurred day after completion.|Day 0 through Day 28|Randomized participants who received randomized therapy (intention to treat population).||number of patients with at least 1 event|||Number
729153|NCT00386425|Secondary|28-Day Time Averaged Sequential Organ Failure (SOFA) Score|The presence of 5 organ dysfunctions (cardiovascular, respiratory, renal, hepatic, coagulation) was assessed using a Sequential Organ Failure Assessment (SOFA) score. Each organ has a possible dysfunction score of 0 to 4, for a total SOFA score range of 0 (no organ dysfunction) to 20 (all organs with dysfunction). SOFA scores were time-averaged.|Day 0, Day 28|ITT population||Units on a scale||Standard Deviation|Mean
729154|NCT00386425|Secondary|Hospital Mortality (up to Day 90)||Day 0 to hospital discharge or Day 90|ITT population||Percentage of participants|||Number
729155|NCT00386425|Secondary|Day 28 All-Cause Mortality||Day 0 through Day 28|ITT population||percentage of participants|||Number
729156|NCT00386425|Secondary|Mean Change in Protein C Level From Study Day 1 to Study Day 7 in Patients With Moderate and Severe Protein C Deficiency|"Moderate Protein C Deficiency: A protein C level greater than half the lower limit of normal.
Severe Protein C Deficiency: A protein C level less than or equal to half the lower limit of normal."|Day 1, Day 7|ITT moderately deficient population, ITT severely deficient population||Percent Protein C Activity||Standard Deviation|Mean
729157|NCT00386425|Primary|Mean Change in Protein C Levels From Day 1 to Day 7|Mean change in protein C from Study Day 1 to Study Day 7 was tested using an unadjusted two-sample t-test with a two-sided alpha of 0.05. To be included in the primary analysis, Intention-to-Treat (ITT) patients must have at least 1 protein C value available at 24 hours or earlier and at least 1 protein C value at a post-24-hour timepoint.|Day 1, Day 7|Intent to Treat (ITT) Last Observation Carried Forward (LOCF) population.||Percent Protein C Activity||Standard Deviation|Mean
729158|NCT00386477|Primary|Number of Participants Who Experienced Composite Endometritis Plus Wound Complications.|Endometritis was diagnosed clinically as uterine pain and fever requireing antibiotics. Wound complications included wound infection, seroma, hematoma, or separation.|1 month|Randomization||participants|||Number
729159|NCT00386607|Secondary|Percentage of Patients Achieving Blood Pressure Control Target of < 140/90 mmHg in Extension Treatment||Month 18|Treated population||Percentage of patients|||Number
729160|NCT00386607|Secondary|Change From Baseline in Mean Sitting Systolic Blood Pressure||Baseline and Month 18|Treated population||mmHg||Standard Deviation|Mean
729161|NCT00386607|Primary|Overall Percentage of Patients With Adverse Events|adverse event data obtained from both the core study and the 6 month extension study.|Month 18|||percentage of patients|||Number
729162|NCT00386607|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure||Baseline and Month 18|Treated population||mmHg||Standard Deviation|Mean
729163|NCT00386607|Secondary|Percentage of Patients Achieving Blood Pressure Control Target of < 140/90 mmHg||.Weeks 2, 4, 6, 10, 14, 18, 28, 41, and 54|Treated population||Percentage of patients|||Number
729164|NCT00386607|Secondary|Change From Baseline in Mean Sitting Systolic Blood Pressure.||Baseline and Weeks 2, 4, 6, 10, 14, 18, 28, 41 and 54|Treated population||mmHg||Standard Deviation|Mean
729165|NCT00386607|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure.||Baseline and Weeks 2, 4, 6, 10, 14, 18, 28, 41, and 54|Treated population||mmHg||Standard Deviation|Mean
729166|NCT00386607|Primary|Overall Percentage of Patients With Adverse Events||Month 12|Treated population: All patients who received at least one dose of Aliskiren/Valsartan||percentage of patients|||Number
729167|NCT00366899|Secondary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Relative to 7vPnC Group After the Toddler Dose|Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after toddler dose (12 months of age)|Evaluable pneumococcal immunogenicity (per protocol) had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate antibody concentration for the specified serotype.||μg/mL||95% Confidence Interval|Geometric Mean
729168|NCT00366899|Secondary|Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Relative to the 7vPnC Group After the Toddler Dose|Percentages of Participants achieving WHO predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after the toddler dose (12 months of age)|Evaluable pneumococcal immunogenicity (per protocol) population had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate IgG antibody concentration to the given serotype.||percentage of participants||95% Confidence Interval|Number
729169|NCT00366899|Primary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the 2-Dose Infant Series and Before Toddler Dose|Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after infant series dose 2 (6 months of age) and before the toddler dose (11 months of age)|Evaluable pneumococcal immunogenicity (per protocol) had valid and determinate assay results, and had no other major protocol violations.||μg/mL||95% Confidence Interval|Geometric Mean
729181|NCT00367055|Secondary|Mean Change From Baseline in Insulin Sensitivity Index at Months 18 and 36|Change from baseline was calculated as the Month 18 and 36 values minus the baseline value. Insulin sensitivity is measured as the quantity of glucose metabolized per unit of plasma insulin concentration.|Baseline and Months 18 and 36|ITT Population||micromoles (umol)/kilogram/min/pmol/L||Standard Deviation|Mean
729182|NCT00367055|Secondary|Mean Change From Baseline in CPP Concentration Peak and Incremental Concentration Peak T0-T30 After a 36-month Treatment||Baseline and Month 36||||||
729183|NCT00367055|Secondary|Mean Change From Baseline in CPP Total and Incremental AUC T0-T30 After a 36-month Treatment||Baseline and Month 36||||||
729170|NCT00366899|Primary|Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Group After the 2-Dose Infant Series and Before the Toddler Dose|Percentages of Participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|one month after infant series dose 2 (6 months of age) and before the toddler dose (11 months of age)|The evaluable pneumococcal immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.||percentage of participants||95% Confidence Interval|Number
729171|NCT00366899|Primary|Geometric Mean Antibody Concentration (GMC) of Polio Types 1, 2, and 3 in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose|GMC of Polio as measured using a polio in vitro plaque neutralization.|one month after infant series dose 2 (6 months of age) and after the toddler dose (12 months of age)|Evaluable immunogenicity (per protocol) population had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate antibody concentration/titer for the specified concomitant antigen.||Titers||95% Confidence Interval|Geometric Mean
729172|NCT00366899|Primary|Geometric Mean Antibody Concentration (GMC) of Diptheria and Tetanus in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose|GMC of anti-diphtheria and anti-tetanus toxoids as measured by ELISA (IU/mL).|one month after infant series dose 2 (6 months of age) and after the toddler dose (12 months of age)|Evaluable immunogenicity (per protocol) population had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate antibody concentration/titer for the specified concomitant antigen.||IU/mL||95% Confidence Interval|Geometric Mean
729173|NCT00366899|Primary|Geometric Mean Antibody Concentration (GMC) of Haemophilus Influenzae Type b (Hib) in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose|GMC for Hib polyribosylribitol phosphate as measured by ELISA, expressed in micrograms per milliliter (μg/mL).|one month after infant series dose 2 (6 months of age) and after the toddler dose (12 months of age)|Evaluable immunogenicity (per protocol) population had valid and determinate assay results, and had no other major protocol violations.||μg/mL||95% Confidence Interval|Geometric Mean
729174|NCT00366899|Primary|Geometric Mean Antibody Concentration (GMC) for Hepatitis B in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After Toddler Dose|GMC of anti-hepatitis B surface antigen (HBsAg)using an Food and Drug Administration (FDA) approved in vitro diagnostic kit.|One month after the infant series (6 months of age) and the toddler dose (12 months of age)|Evaluable immunogenicity (per protocol) population had valid and determinate assay results, and had no other major protocol violations.||mIU/mL||95% Confidence Interval|Number
729175|NCT00366899|Other Pre-specified|Geometric Mean Antibody Titer (OPA) in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose|Antibody functionality/geometric mean titer (GMT) as measured by opsonophagocytic activity assay(OPA) for7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|one month after infant series dose 2 and after the toddler dose|OPAS were done in a subset of approximately 100 subjects (range 90-100 per serotype) in the 13vPnC group||Titers||95% Confidence Interval|Geometric Mean
729176|NCT00366899|Other Pre-specified|Percentage of Subjects Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose|Percentage of subjects achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. (This is not a geometric mean comparison as suggested by the table row heading).|one month after infant series dose 2 and after the toddler dose|OPAs were done in a subset of approximately 100 subjects (range 90-100 per serotype) in the 13vPnC group||% Achieving OPA Titer ≥1:8||95% Confidence Interval|Geometric Mean
729177|NCT00366899|Primary|Geometric Mean Antibody Concentration (GMC) of Pertussis in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose|GMC of Pertussis (PT, FHA, PRN) were measured using an anti-Bordetella pertussis enzyme-linked immunosorbent assay (ELISA). Results were recorded in ELISA units per milliliter (EU/mL)|one month after infant series dose 2 (6 months of age) and after the toddler dose (12 months of age)|Evaluable immunogenicity (per protocol) population adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.||EU/mL||95% Confidence Interval|Geometric Mean
729178|NCT00366899|Primary|Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose|Percentage of Participants achieving predefined antibody threshold levels for Pertussis Toxoid (PT) ≥5 ELISA units per milliliter (EU/mL), Filamentous Haemagglutinin (FHA) ≥5 or ≥7.82 EU/mL, and Pertactin (PRN) ≥5 EU/mL, ≥10.0 Milli-International Units Per Milliliter (mIU/mL) for Hepatitis B, Haemophilus Influenzae type b (Hib) 0.15 μg/ml, 0.01 or 0.1 IU/mL for Diphtheria, 0.1 IU/mL for Tetanus, and ≥1:8 titer for Polio (Type 1, 2, and 3) with the corresponding 95% CI for antigens are presented.|One month after the infant series (6 months of age) and after the toddler dose (12 months of age)|Evaluable immunogenicity (per protocol) population who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate postinfant antibody concentration/titer for the given concomitant antigen.||percentage of participants||95% Confidence Interval|Number
729179|NCT00366899|Primary|Percentage of Participants Reporting Pre-Specified Systemic Events|Systemic events (fever ≥ 37.5 degrees Celsius [C], fever ≥ 38 C but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased appetite, irritability, increased sleep, decreased sleep, hives, use of medication (meds) to treat symptoms, and use of medication to prevent symptoms) were reported using an electronic diary. Participants may be represented in more than 1 category.|During the 4-day period after each dose|The safety population included all subjects who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.||Percentage of Participants|||Number
729186|NCT00367055|Secondary|Mean Change From Baseline in FBG at Month 36|Change from baseline was calculated as the Month 36 value minus the baseline value. FBG levels were measured by blood draw.|Baseline and Month 36|Intent-to-Treat (ITT) Population: all participants who received at least one dose of study drug and had an available efficacy evaluation (hyperglycaemic clamp at M18 or M36). This measurement was conducted on participants in the ITT Population who had baseline and M18 and M36 clamp test data available.||millimoles per Liter (mmol/L)||Standard Deviation|Mean
729187|NCT00367055|Secondary|Mean Change From Baseline in HbA1c at Month 36|Change from baseline was calculated as the Month 36 value minus the baseline value. HbA1c levels were measured by blood draw.|Baseline and Month 36|Intent-to-Treat (ITT) Population: all participants who received at least one dose of study drug and had an available efficacy evaluation (hyperglycaemic clamp at M18 or M36). This measurement was conducted on participants in the ITT Population who had baseline and M18 and M36 clamp test data available.||percent change||Standard Deviation|Mean
729188|NCT00367055|Secondary|Median Change From Baseline in the Insulin Secretion Capacity After an 18-month Treatment|Change from baseline was calculated as the Month 18 value minus the baseline value. Insulin secretion capacity is measured in blood (blood level of insulin) and is a response of the pancreatic beta-cells to hyperglycemia induced by a glucose IV bolus, then infusion. Hyperglycemic clamp (HC) is a reference technique to evaluate the initial and the secondary phases of insulin secretion.|Baseline and Month 18|"Intent-to-Treat (ITT) Population: participants receiving at least one dose of study drug with an available efficacy evaluation (HC at M18 or M36). The measurement was conducted on participants who had baseline and M18 and M36 HC test data available. Each HC was validated at both Baseline and Month 36, resulting in different ns for each category."||pmol/L*min||Full Range|Median
729189|NCT00367055|Secondary|Median Change From Baseline in the Ratio M/I After a 36-month Treatment||Baseline and Month 36||||||
729190|NCT00367055|Primary|Median Change From Baseline in the Insulin Secretory Capacity After a 36-month Treatment|Change from baseline in the insulin secretory capacity was measured by the assesment of blood insulin concentrations (conc.) using the hyperglycaemic clamp (HC) technique, per intravenous glucose perfusion by a catheter. Change from baseline for insulin conc peaks (highest conc level) was calculated as the Month 36 value minus the baseline value. Insulin secretion was assessed by calculating AUC during the first 10 minutes of HC (incremental and total AUC0-10 min) and the AUC after the first 10 minutes of the HC (10-180min).|Baseline and Month 36|"Intent-to-Treat (ITT) Population: participants receiving at least one dose of study drug with an available efficacy evaluation (HC at M18 or M36). The measurement was conducted on participants who had baseline and M18 and M36 HC test data available. Each HC was validated at both Baseline and Month 36, resulting in different ns for each category."||picomoles/L per minute (pmol/L*min)||Full Range|Median
729191|NCT00367133|Secondary|Percentage of Eyes With a Change in Central Subfield Thickness on OCT <250 Microns From Baseline to 3 Years|Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. The average of 2 baseline central subfield thickness measurements was used for analysis.If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield. Negative change denotes an improvement.|Baseline to 3 years|The study discontinued early. Only subjects with 3 years data are included in 3 year analysis.||Percentage of Eyes|||Number
729192|NCT00367133|Secondary|Change in Central Subfield Thickness on OCT Baseline to 3 Years|Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. The average of 2 baseline central subfield thickness measurements was used for analysis.If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield. Negative change denotes an improvement.|baseline to 3 years|The study discontinued early. Only subjects with 3 years data are included in 3 year analysis.||Microns||Inter-Quartile Range|Median
729193|NCT00367133|Secondary|Change in Central Subfield Thickness on OCT Baseline to 3 Years|Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. The average of 2 baseline central subfield thickness measurements was used for analysis.If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield. Negative change denotes an improvement.|Baseline to 3 years|The study discontinued early. Only subjects with 3 years data are included in 3 year analysis.||Microns||Standard Deviation|Mean
729194|NCT00367133|Secondary|Central Subfield Thickness on Optical Coherence Tomography (OCT) at Three Years|Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield.|3 years|The study discontinued early. Only subjects with 3 years data are included in 3 year analysis.||Microns||Inter-Quartile Range|Median
729195|NCT00367133|Secondary|Distribution of Visual Acuity Change Baseline to 3 Years|Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale=97, worst=0|Baseline to 3 years|The study discontinued early. Only subjects with 3 years data are included in 3 year analysis.||Percentage of Eyes|||Number
729196|NCT00367133|Secondary|Change in Visual Acuity From Baseline to 3 Years|Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best Value on the scale=97, Worst Value=0|Baseline to 3 year|The study discontinued early. Only subjects with 3 years data are included in 3 year analysis.||Letter Score||Inter-Quartile Range|Median
729197|NCT00367133|Secondary|Change in Visual Acuity From Baseline to 3 Years|Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement.|Baseline to 3 year|The study discontinued early. Only subjects with 3 years data are included in 3 year analysis.||Letter Score||Standard Deviation|Mean
729198|NCT00367133|Secondary|Central Subfield Thickness < 250 Microns at 2 Years|Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield.|2 Years|Only subjects with available OCTs at baseline and 2 years are included in the OCT analysis.||Percentage of Eyes|||Number
729199|NCT00367133|Secondary|Overall Central Subfield Thickening Decreased by >=50% Baseline to 2 Years|Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield.|Baseline to 2 Years|Only subjects with available OCTs at baseline and 2 years are included in the OCT analysis.||Percentage of Eyes|||Number
729200|NCT00367133|Secondary|Median Change in Central Subfield Thickness Baseline to 2 Years|Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. The average of 2 baseline central subfield thickness measurements was used for analysis.If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield. Negative change denotes an improvement.|Baseline to 2 Years|Only subjects with an available OCT's at baseline and 2 years are included in the OCT analysis.||Microns||Inter-Quartile Range|Median
729201|NCT00367133|Secondary|Mean Change in Central Subfield Thickness Baseline to 2 Years|Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. The average of 2 baseline central subfield thickness measurements was used for analysis.If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield. Negative change denotes and improvement.|Baseline to 2 years|Only subjects with available OCTs at baseline and 2 years are included in the OCT analysis.||Microns||Standard Deviation|Mean
729202|NCT00367133|Primary|Distribution of Change in Visual Acuity Baseline to 2 Years|Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method.|baseline to 2 years|The primary analysis included all randomized eyes and followed the intent-to-treat principle||Percentage of Eyes|||Number
729203|NCT00367133|Primary|Median Change in Visual Acuity Baseline to 2 Years|Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement.|Baseline to 2 Years|The primary analysis included all randomized eyes and followed the intent-to-treat principle.||Letter score||Inter-Quartile Range|Median
729204|NCT00367133|Secondary|Central Subfield Thickness at 2 Years|Median central subfield thickness at two-years. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield.|2 Years|Only subjects with an available Optical coherence tomography (OCT) at baseline and 2 years are included in the OCT analysis.||Microns||Inter-Quartile Range|Median
729205|NCT00367133|Primary|Change In Visual Acuity [Measured With Electronic-Early Treatment Diabetic Retinopathy Study (E-ETDRS)]Baseline to 2 Years.|Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale 97, worst 0.|Baseline to 2 Years|The primary analysis included all randomized eyes and followed the intent-to-treat principle.||Letter score||Standard Deviation|Mean
729206|NCT00377962|Secondary|Number of Patients Discontinued From the Study Due to Adverse Events From Month 12 to End of Study (Month 24)||Month 12 to end of study (Month 24)|Intent-to-treat (ITT) population: All randomized patients who were given at least 1 dose of study drug and had at least 1 post-baseline assessment.||Participants|||Number
729207|NCT00377962|Secondary|Mean Days of Hospitalization From Baseline to End of Study (Month 24)||Baseline to end of study (Month 24)|Intent-to-treat (ITT) population: All randomized patients who were given at least 1 dose of study drug and had at least 1 post-baseline assessment.||Days||Standard Deviation|Mean
729208|NCT00377962|Secondary|Change in Left Ventricular Function (Filling and Ejection Fraction Parameters) From Baseline to End of Study (Month 24) in the Heart Transplant Subgroup|Left ventricular function was assessed by echocardiography which was performed according to local routine practice. Echocardiography parameters were filling fraction (FF) and ejection fraction (EF). A positive change score indicates improved left ventricular function.|Baseline to end of study (Month 24)|Patients in the heart transplant subgroup of the intent-to-treat (ITT) population which included all randomized patients who were given at least 1 dose of study drug and had at least 1 post-baseline assessment.||%||Standard Deviation|Mean
729209|NCT00377962|Secondary|Change in Left Ventricular Function (Diameter and Thickness Parameters) From Baseline to End of Study (Month 24) in the Heart Transplant Subgroup|Left ventricular function was assessed by echocardiography which was performed according to local routine practice. Echocardiography parameters were left ventricular end diastolic diameter (LVEDD), left ventricular end systolic diameter (LVESD), interventricular septal wall thickness (IVSTd), and posterior wall thickness (PWTd). A positive change score indicates improved left ventricular function.|Baseline to end of study (Month 24)|Patients in the heart transplant subgroup of the intent-to-treat (ITT) population which included all randomized patients who were given at least 1 dose of study drug and had at least 1 post-baseline assessment.||cm||Standard Deviation|Mean
729224|NCT00386776|Primary|Patient Post Medical History Assessment Questionnaire|"The questionnaire consisted of 10 Likert scales questions assessing the computer-based history. The Likert scale ranged from 1 for 'Not at all' to 10 for 'Very'.
We computed the mean of the responses to the question “How helpful were the questions when thinking about your health? We also calculated a total score by averaging the mean scores of the 10 questions."|Immediately after taking the medical history|We analyzed post medical history questionnaire responses for the 32 patients who completed the medical history patients.||units on a scale||Full Range|Mean
729210|NCT00377962|Secondary|Change in Forced Vital Capacity (FVC) From Baseline to End of Study (Month 24) in the Lung Transplant Subgroup|Forced vital capacity (FVC) was measured by spirometry conducted according to internationally accepted standards. FVC is the volume delivered during an expiration made as forcefully and completely as possible starting from full inspiration. A positive change score indicates improved lung function.|Baseline to end of study (Month 24)|Patients in the lung transplant subgroup of the intent-to-treat (ITT) population which included all randomized patients who were given at least 1 dose of study drug and had at least 1 post-baseline assessment.||Liters||Standard Deviation|Mean
729211|NCT00377962|Secondary|Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to End of Study (Month 24) in the Lung Transplant Subgroup|Forced expiratory volume in 1 second (FEV1) was measured by spirometry conducted according to internationally accepted standards. FEV1 is the volume delivered in the first second of a forced vital capacity (FVC) maneuver. A positive change score indicates improved lung function.|Baseline to end of study (Month 24)|Patients in the lung transplant subgroup of the intent-to-treat (ITT) population which included all randomized patients who were given at least 1 dose of study drug and had at least 1 post-baseline assessment.||Liters||Standard Deviation|Mean
729212|NCT00377962|Secondary|Number of Patients in Need of Dialysis From Month 12 to End of Study (Month 24)||Month 12 to end of study (Month 24)|The intent-to-treat (ITT) population consisted of all patients as randomized, who were given at least one dose of study drug and had at least one post-baseline assessment. (Extension study)||Participants|||Number
729213|NCT00377962|Secondary|Number of Patients Who Died and Number of Patients With Graft Loss From Month 12 to End of Study (Month 24)|Number of patients not alive and number of patients with loss of their graft.|Month 12 to end of study (Month 24)|Intent-to-treat (ITT) population: All randomized patients who were given at least 1 dose of study drug and had at least 1 post-baseline assessment.||Participants|||Number
729214|NCT00377962|Secondary|Number of Patients With Biopsy-proven Acute Rejection From Month 12 to End of Study (Month 24)|Biopsy-proved acute rejection was defined as a treated acute rejection confirmed by biopsy, graded locally according to the International Society for Heart & Lung Transplantation (ISHLT) criteria. A treated acute rejection was defined as an acute rejection clinically suspected, whether biopsy-proven or not, which had been treated and confirmed by the investigator according to the response to therapy.|Month 12 to end of study (Month 24)|Intent-to-treat (ITT) population: All randomized patients who were given at least 1 dose of study drug and had at least 1 post-baseline assessment.||Participants|||Number
729215|NCT00377962|Secondary|Change in Serum Creatinine From Baseline to End of Study (Month 24)|Renal function was assessed by determining serum creatinine using standard laboratory methods. A positive change score indicates improved renal function.|Baseline to end of study (Month 24)|Intent-to-treat (ITT) population: All randomized patients who were given at least 1 dose of study drug and had at least 1 post-baseline assessment.||μmol/L||Standard Deviation|Mean
729216|NCT00377962|Secondary|Change in Measured Glomerular Filtration Rate (mGFR) From Baseline to End of Study (Month 24)|Renal function was assessed by determining the measured glomerular filtration rate (mGFR) using creatinine ethylenediamine tetraacetic acid (Cr-EDTA) clearance or an equivalent method. A positive change score indicates improved renal function.|Baseline to end of study (Month 24)|Intent-to-treat (ITT) population: All randomized patients who were given at least 1 dose of study drug and had at least 1 post-baseline assessment.||mL/min||Standard Deviation|Mean
729217|NCT00377962|Primary|Change in Measured Glomerular Filtration Rate (mGFR) From Baseline to Month 12|Renal function was assessed by determining the measured glomerular filtration rate (mGFR) using creatinine ethylenediamine tetraacetic acid (Cr-EDTA) clearance or an equivalent method. A positive change score indicates improved renal function.|Baseline to Month 12|Intent-to-treat (ITT) population: All randomized patients who were given at least 1 dose of study drug and had at least 1 post-baseline assessment.||mL/min||Standard Deviation|Mean
729218|NCT00386776|Secondary|Completeness of Patients' Problem Lists|The experimental design was revised from a two arm experimental and control study to a one arm experimental study. Therefore this secondary measure no longer applied.|||||||
729219|NCT00386776|Secondary|Number of Telephone Calls and E-mail Messages Between Patients and Physicians|The experimental design was revised from a two arm experimental and control study to a one arm experimental study. Therefore this secondary measure no longer applied.|||||||
729220|NCT00386776|Secondary|Time Per Visit|The experimental design was revised from a two arm experimental and control study to a one arm experimental study. Therefore this secondary measure no longer applied.|||||||
729221|NCT00386776|Secondary|Number of Office Visits by Patients|The experimental design was revised from a two arm experimental and control study to a one arm experimental study. Therefore this secondary measure no longer applied.|||||||
729222|NCT00386776|Primary|Physician Post Visit Questionnaire|"The questionnaire consisted of 6 Likert scales questions assessing helpfulness of the computer-based history for the physician at the time of the patient visit. The Likert scale ranged from 1 for 'Not at all helpful' to 10 for 'Very helpful'. We computed the mean of the responses to the questions “How helpful was it for your patient to have taken the computer interview before seeing you?
” and the question To what extent do you think the computer summary helped you to provide better care to your patient? We also calculated a total score by averaging the mean scores of the 6 questions. In addition we calculated the combined mean of the physician responses to the post-visit questionnaires when physicians filled out the questionnaire but their patients did not."|One day after the patient visit|We analyzed post visit physician questionnaire responses for the patients who completed the medical history and who showed up for their appointment.||units on a scale||Full Range|Mean
729223|NCT00386776|Primary|Patient Post Visit Questionnaire|The questionnaire consisted of 6 Likert scales questions assessing helpfulness of the computer-based history for the patient at the time of the visit. The Likert scale ranged from 1 for 'Not at all helpful' to 10 for 'Very helpful'. We computed the mean of the responses to the question “How helpful was it for you to have taken the computer interview before seeing your doctor?” We also calculated a total score by averaging the mean scores of the 6 questions. In addition we calculated the combined mean of the responses of three of the patients whose doctors did not complete their post-visit questionnaire.|One day after the visit with the physician|We analyzed post medical history questionnaire responses for the 23 patients who completed the medical history patients.||units on a scale||Full Range|Mean
729226|NCT00387010|Secondary|Summary of Participants' Successful Dosing Levels of Fentanyl Buccal Tablets to Control Episodes of Breakthrough Pain (BTP)|During the dose titration period, participants self-administered FBT, starting at 100, 200 or 400 mcg (depending on analgesic used pre-study) and titrated to 600 and 800 mcg if needed. For each breakthrough pain (BTP) episode, participants took a dose, and did not take further study drug if adequate pain relief was achieved. If pain was not controlled within 30 minutes, the same dose level was repeated. If pain relief was inadequate 30 minutes after the second dose, usual rescue medication was taken for that BTP episode. Doses were adjusted until pain relief was adequate and side effects were tolerated. This outcome summarizes the successful dose levels identified during the titration period.|up to 10 days|Safety analysis set||participants|||Number
729227|NCT00387010|Secondary|Clinical Assessment of Patient Function - Patient's Enjoyment of Life - at Approximately Week 5|At the endpoint of the study (week 4 of Treatment period or last post baseline visit) investigators completed the Clinical Assessment of Patient Function Scale which asks 5 questions about the effect of study treatment on the patient's ability to function. This question asks about the patient's enjoyment of life.|approximately week 5|Full analysis set||participants|||Number
729228|NCT00387010|Secondary|Clinical Assessment of Patient Function - Patient's Relationship With Others - at Approximately Week 5|At the endpoint of the study (week 4 of Treatment period or last post baseline visit) investigators completed the Clinical Assessment of Patient Function Scale which asks 5 questions about the effect of study treatment on the patient's ability to function. This question asks about the patient's relationship with others.|approximately week 5|Full analysis set||participants|||Number
729229|NCT00387010|Secondary|Clinical Assessment of Patient Function - Patient's Ability to Work/Perform Activities of Daily Living - at Approximately Week 5|At the endpoint of the study (week 4 of Treatment period or last post baseline visit) investigators completed the Clinical Assessment of Patient Function Scale which asks 5 questions about the effect of study treatment on the patient's ability to function. This question asks about the patient's ability to work and perform activities of daily living.|approximately week 5|Full analysis set||participants|||Number
729230|NCT00387010|Secondary|Clinical Assessment of Patient Function - Patient's Walking Ability - at Approximately Week 5|At the endpoint of the study (week 4 of Treatment period or last post baseline visit) investigators completed the Clinical Assessment of Patient Function Scale which asks 5 questions about the effect of study treatment on the patient's ability to function. This question asks about the patient's walking ability.|approximately week 5|Full analysis set. One participant was not assessed by the investigator.||participants|||Number
729231|NCT00387010|Secondary|Clinical Assessment of Patient Function - General Activities - at Approximately Week 5|At the endpoint of the study (week 4 of Treatment period or last post baseline visit) investigators completed the Clinical Assessment of Patient Function Scale which asks 5 questions about the effect of study treatment on the patient's ability to function. This question asks about the patient's general activities.|approximately week 5|Full analysis set||participants|||Number
729232|NCT00387010|Secondary|Patient Assessment of Ability to Enjoy Life at Approximately Week 5|At the endpoint of the study (week 4 of Treatment period or last post baseline visit) participants completed the Patient Assessment of Function Scale which asks 7 questions about the effect of study treatment on the patient's ability to function. This question asks about the ability to enjoy life.|approximately week 5|Full analysis set of participants who answered the question||participants|||Number
729233|NCT00387010|Secondary|Patient Assessment of Ability to Have Sex at Approximately Week 5|At the endpoint of the study (week 4 of Treatment period or last post baseline visit) participants completed the Patient Assessment of Function Scale which asks 7 questions about the effect of study treatment on the patient's ability to function. This question asks about the ability to have sex.|approximately week 5|Full analysis set of participants who answered the question||participants|||Number
729234|NCT00387010|Secondary|Patient Assessment of Ability to Participate in Social Events at Approximately Week 5|At the endpoint of the study (week 4 of Treatment period or last post baseline visit) participants completed the Patient Assessment of Function Scale which asks 7 questions about the effect of study treatment on the patient's ability to function. This question asks about the ability to participate in social events.|approximately week 5|Full analysis set of participants who answered the question||participants|||Number
729235|NCT00387010|Secondary|Patient Assessment of Ability to Exercise at Approximately Week 5|At the endpoint of the study (week 4 of Treatment period or last post baseline visit) participants completed the Patient Assessment of Function Scale which asks 7 questions about the effect of study treatment on the patient's ability to function. This question asks about the ability to exercise.|approximately week 5|Full analysis set of participants who answered the question||participants|||Number
729236|NCT00387010|Secondary|Patient Assessment of Ability to Walk at Approximately Week 5|At the endpoint of the study (week 4 of Treatment period or last post baseline visit) participants completed the Patient Assessment of Function Scale which asks 7 questions about the effect of study treatment on the patient's ability to function. This question asks about the ability to walk.|approximately week 5|Full analysis set of participants who answered the question||participants|||Number
729237|NCT00387010|Secondary|Patient Assessment of Ability to Perform at Work at Approximately Week 5|At the endpoint of the study (week 4 of Treatment period or last post baseline visit) participants completed the Patient Assessment of Function Scale which asks 7 questions about the effect of study treatment on the patient's ability to function. This question asks about the ability to perform at work and includes both work outside the home and housework.|approximately week 5|Full analysis set of participants who answered the question||participants|||Number
729238|NCT00387010|Secondary|Patient Assessment of Ability to Go to Work at Approximately Week 5|At the endpoint of the study (week 4 of Treatment period or last post baseline visit) participants completed the Patient Assessment of Function Scale which asks 7 questions about the effect of study treatment on the patient's ability to function. This question asks about the ability to go to work.|approximately week 5|Full analysis set of participants who answered the question||participants|||Number
729239|NCT00387010|Secondary|Medication Preference From the Pain Flare Treatment Satisfaction Questionnaire at Approximately Week 5|The summary question from the Pain Flare Treatment Satisfaction Questionnaire asked participants which medication they preferred to use for their break-through pain. Options were 1) Prior medication 2) Study medication 3) no preference|approximately week 5|Full analysis set of participants who answered the questions.||participants|||Number
729240|NCT00387010|Secondary|Change From Baseline in the West Haven-Yale Multidimensional Pain Inventory Subscales at Approximately Week 5|Change from baseline to endpoint (week 4 of Treatment period or last post baseline visit) in the Multidimensional Pain Inventory Subscales. Answers to questions in the MPI are captured on a 7-point scale, with 0=most positive answer and 6= least positive answer. Twenty questions focus on pain, fourteen on a significant other's response when participant is in pain, and eighteen questions about daily activities. There are a total of 13 subscales with variable ranges. Subscales and corresponding ranges are listed in the results table. The General Activity category combines the Household Chores, Outdoor Work, Activities Away from Home, and Social Activities categories.|Day 0 (baseline), approximately week 5|Full analysis set||units on a scale||Standard Deviation|Mean
729241|NCT00387010|Secondary|Change From Baseline in the Beck Depression Inventory at Approximately Week 5|Change from baseline to endpoint (week 4 of Treatment period or last post baseline visit) in the Beck Depression Inventory (BDI). The BDI is a self-reporting instrument that asks 21 questions regarding how the participant felt in the past few days. Answers are in sentence form, and offer a scale where the first answer (worth 0 points) indicates no depression and the fourth answer (worth 3 points) indicates significant depression. Totals (0-63) are grouped so that totals of 1-10 are interpreted as 'These ups and downs are considered normal' and scores >40 indicate extreme depression.|Day 0 (baseline), approximately week 5|Full analysis set of participants who answered the questions.||units on a scale||Standard Deviation|Mean
729242|NCT00387010|Secondary|Change From Baseline in the Pain Anxiety Symptoms Scale (PASS) Subscale Scores at Approximately Week 5|The change from baseline to approximately week 5 in the PASS subscale scores. PASS asks participants to indicate how often they engage in each of the 40 thoughts or activities that represent anxiety symptoms on a scale of 0=never to 5=always. Those 40 questions are organized into four subscales: fear, cognitive anxiety, somatic anxiety, and escape/avoidance. Each subscale score is obtained by summing the answers to the ten items in the subscore resulting in a range of 0-50.|Day 0 (baseline), approximately week 5|Full analysis set||units on a scale||Standard Deviation|Mean
729243|NCT00387010|Primary|Change From Baseline in the Pain Anxiety Symptoms Scale (PASS) Total Score at Approximately Week 5|The change from baseline to approximately week 5 in the PASS total score. PASS asks participants to indicate how often they engage in each of the 40 thoughts or activities that represent anxiety symptoms on a scale of 0=never to 5=always. The total score has a range of 0-200.|Day 0 (baseline), approximately week 5|Full analysis set||units on a scale||Standard Deviation|Mean
729244|NCT00387023|Primary|Number of Participants With Complete Response (CR) or Partial Response (PR)|Tumor response to therapy measured by tumor size as measured radiographically at baseline and at three months from baseline. Tumor response classified as complete response (CR) or partial response (PR), or stable disease (SD), or progressive disease (PD) using International Workshop Standardized Response Criteria (IWC) for Non-Hodgkin's Lymphomas. If the orbital/ocular adnexal lymphoma was not evaluable radiographically, clinical evaluation using slit lamp biomicroscopy was used to assess PR or CR.|3 months|||participants|||Number
729245|NCT00387036|Secondary|Exercise Endurance Time|Difference in exercise endurance time between Fluticasone Propionate treatment and placebo treatment at the end of the treatment period.|2 Weeks|Intention to treat analysis. All patients were included.||Minutes||Standard Deviation|Mean
729246|NCT00387036|Primary|Standardized Dyspnea Score at Isotime During Exercise|"Difference in standardized dyspnea rating at isotime during constant load exercise in patients with COPD between Fluticasone Propionate treatment and placebo treatment at the end of the treatment period.
Isotime is the duration of the shortest exercise test on all treatment days (or the longest exercise time point common to all constant-load exercise tests). The standardized dyspnea score will be measured with the modified 10-point Borg Scale (0 [Best] - 10 [Worst] )."|2 Weeks|Intention to treat analysis. All patients were included.||Units on a Scale||Standard Deviation|Mean
729247|NCT00387088|Secondary|Clinically Relevant Findings in Physical Examination and ECG|Clinically relevant findings in Physical Examination and ECG at end of treatment|End of treatment|Treated set||participants|||Number
729248|NCT00387088|Secondary|Marked Changes From Baseline in Vital Signs at End of Treatment|"Marked changes from baseline in vital signs (diastolic and systolic blood pressure (DBP and SBP) and pulse rate (PR)) at end of treatment.
SBP - Increase means SBP >150 mmHg and an increase above baseline of >25 mmHg. SBP - Decrease means SBP <100 mmHg and a decrease below baseline of >10 mmHg.
DBP - Increase means DBP >90 mmHg and an increase above baseline of >10 mmHg. DBP - Decrease means DBP <60 mmHg and a decrease below baseline of >10 mmHg.
PR - Increase means PR >100 bpm and an increase above baseline of >10 bpm. PR - Decrease means PR <60 bpm and a decrease below baseline of >10 bpm."|Baseline and end of treatment|Treated set||participants|||Number
729249|NCT00387088|Secondary|Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 337|Trough FVC is the mean maximum volume of air that can be forcibly expired from the lungs; measured approximately 24 hours after the last administration of study drug.|Baseline and Day 337|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. 133 participants from the FAS were excluded due to insufficient FVC data.||Litres||Standard Error|Least Squares Mean
729250|NCT00387088|Secondary|Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 169|Trough FVC is the mean maximum volume of air that can be forcibly expired from the lungs; measured approximately 24 hours after the last administration of study drug.|Baseline and Day 169|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. 133 participants from the FAS were excluded due to insufficient FVC data.||Litres||Standard Error|Least Squares Mean
729251|NCT00387088|Secondary|Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 29|Trough FVC is the mean maximum volume of air that can be forcibly expired from the lungs; measured approximately 24 hours after the last administration of study drug.|Baseline and Day 29|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. 147 participants from the FAS were excluded due to insufficient FVC data.||Litres||Standard Error|Least Squares Mean
729252|NCT00387088|Secondary|Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Domain Score at Day 169|The SGRQ domain score (symptom, activity and impact) measures quality of life on a continuous scale ranging from 0=best state to 100=worst state|Baseline and Day 169|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. Up to 534 participants from the FAS were excluded due to insufficient SGRQ data.||Units on a scale||Standard Error|Least Squares Mean
729253|NCT00387088|Secondary|Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Domain Score at Day 337|The SGRQ domain score (symptom, activity and impact) measures quality of life on a continuous scale ranging from 0=best state to 100=worst state|Baseline and Day 337|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. Up to 534 participants from the FAS were excluded due to insufficient SGRQ data.||Units on a scale||Standard Error|Least Squares Mean
729254|NCT00387088|Secondary|Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at Day 169|The SGRQ total score measures quality of life on a continuous scale ranging from 0=best state to 100=worst state|Baseline and Day 169|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. 534 participants from the FAS were excluded due to insufficient SGRQ data.||Units on a scale||Standard Error|Least Squares Mean
729255|NCT00387088|Secondary|Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at Day 337|The SGRQ total score measures quality of life on a continuous scale ranging from 0=best state to 100=worst state|Baseline and Day 337|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. 534 participants from the FAS were excluded due to insufficient SGRQ data.||Units on a scale||Standard Error|Least Squares Mean
729256|NCT00387088|Secondary|Number of Patients With at Least One Hospitalisation for a COPD Exacerbation|Number of patients with at least one hospitalisation for a COPD exacerbation (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment)|During actual study treatment period (planned Day 1 to Day 337)|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data.||participants|||Number
729257|NCT00387088|Secondary|Number of Hospitalisations for COPD Exacerbations Per Patient - naïve Estimate|Number of hospitalisations for COPD exacerbations (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient not adjusted for treatment exposure (i.e. naïve estimate)|During actual study treatment period (planned Day 1 to Day 337)|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data.||hospitalisations for COPD exacerbations||Full Range|Median
729258|NCT00387088|Secondary|Number of Hospitalisations for COPD Exacerbations Per Patient - Exposure Adjusted|Number of hospitalisations for COPD exacerbations (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient adjusted by length of treatment exposure (i.e. no. of exacerbations multiplied by 365.25 and then divided by days of treatment exposure)|During actual study treatment period (planned Day 1 to Day 337)|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data.||hospitalisations for COPD exacerbations||Full Range|Median
729259|NCT00387088|Secondary|Time to First Hospitalisation for COPD Exacerbation|Time to first hospitalisation for COPD exacerbation (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment). Time is days from start of study treatment to onset of exacerbation|During actual study treatment period (planned Day 1 to Day 337)|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data.||Days||95% Confidence Interval|Median
729260|NCT00387088|Secondary|Number of Patients With at Least One COPD Exacerbation|Number of patients with at least one COPD exacerbation (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment)|During actual study treatment period (planned Day 1 to Day 337)|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data.||participants|||Number
729261|NCT00387088|Secondary|Number of COPD Exacerbations Per Patient - naïve Estimate|Number of COPD exacerbations (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient not adjusted for treatment exposure (i.e. naïve estimate)|During actual study treatment period (planned Day 1 to Day 337)|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data.||COPD exacerbations||Full Range|Median
729262|NCT00387088|Secondary|Number of COPD Exacerbations Per Patient - Exposure Adjusted|Number of COPD exacerbations (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient adjusted by length of treatment exposure (i.e. number of exacerbations multiplied by 365.25 and then divided by days of treatment exposure)|During actual study treatment period (planned Day 1 to Day 337)|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data.||COPD exacerbations per year||Full Range|Median
729263|NCT00387088|Secondary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 169|Trough FEV1 is the mean volume of air that can be forced out in one second after taking a deep breath approximately 24 hours after the last administration of study drug.|Baseline and Day 169|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. 133 participants from the FAS were excluded due to insufficient FEV1 data.||Litres||Standard Error|Least Squares Mean
729264|NCT00387088|Secondary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 29|Trough FEV1 is the mean volume of air that can be forced out in one second after taking a deep breath approximately 24 hours after the last administration of study drug.|Baseline and Day 29|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. 147 participants from the FAS were excluded due to insufficient FEV1 data.||Litres||Standard Error|Least Squares Mean
729265|NCT00387088|Primary|Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation|Time to first COPD exacerbation (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment). Time is days from start of study treatment to onset of exacerbation.|During actual study treatment period (planned Day 1 to Day 337)|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data.||Days||95% Confidence Interval|Median
729266|NCT00387088|Primary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 337|Trough FEV1 is defined as the FEV1 measured at the -10 min time point at the end of the dosing interval (24 h post drug administration).|Baseline and Day 337|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. 133 participants from the FAS were excluded due to insufficient FEV1 data.||Litres||Standard Error|Least Squares Mean
729270|NCT00388973|Secondary|Change From Baseline in Somatic Symptoms Cluster From the Hamilton Anxiety Scale (HAM-A)|The Somatic symptom Cluster of the Hamilton Anxiety Scale is a 7 item cluster associated with somatic symptoms *somatic muscular, somatic sensory, cardiovascular system, respiratory system, gastrointestinal system, genitourinary system, autonomic system) with a range of values from 0 to 28, worst value 28, best value 0|Baseline to Week 9|All randomized patients who took at least one dose of study medication and had at least one post baseline assessment, with last observation carried forward to week 9 for patients who did not complete the study.||units on scale||Full Range|Median
729271|NCT00388973|Secondary|Change From Baseline in Suicidal Thoughts as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Item 10|The suicide item is a single item of the Montgomery-Asberg Depression Rating Scale with a range of values from 0 to 6, worst value 6, best value 0|Baseline to Week 9|All randomized patients who took at least one dose of study medication and had at least one post baseline assessment, with last observation carried forward to week 9 for patients who did not complete the study.||units on scale||Full Range|Median
729272|NCT00388973|Secondary|Change From Baseline in Sleep Quality as Measured by the Pittsburgh Sleep Quality Index|The Pittsburgh Sleep Quality Index is an eighteen questionnaire scored with 7 sleep component scores each on a 0 to 3 scale, total score range from 0 to 21, worst value 21, best value 0|Baseline to Week 9|All randomized patients who took at least one dose of study medication and had at least one post baseline assessment, with last observation carried forward to week 9 for patients who did not complete the study.||units on scale||Standard Deviation|Least Squares Mean
729273|NCT00388973|Secondary|Change From Baseline in Anxiety Symptoms Measured by Hamilton Anxiety 14 Item Scale (HAM-A)|Change in HAM-A total score (total score 0-56), calculated as Week 9 value - baseline value, where lower scores indicate less anxiety.|Baseline to Week 9|All randomized patients who took at least one dose of study medication and had at least one post baseline assessment, with last observation carried forward to week 9 for patients who did not complete the study.||units on a scale||Standard Deviation|Least Squares Mean
729274|NCT00388973|Secondary|Change From Baseline for Satisfaction With Medication From Quality of Life, Enjoyment, Satisfaction Questionaire (Q-LES-Q)|Item 15 the Quality of Life, Enjoyment Satisfaction Questionnaire (score 1 least -5 best) on Q-LES-Q, calculated as Week 9 value - baseline value|Baseline to Week 9|All randomized patients who took at least one dose of study medication and had at least one post baseline assessment, with last observation carried forward to week 9 for patients who did not complete the study. Patients not on medication at baseline would have left the item blank and therefore no change from baseline could be calculated||units on scale||Full Range|Median
729275|NCT00388973|Secondary|Change From Baseline in Health-related Quality of Life, Enjoyment and Satisfaction (Q-LES-Q)|Q-LES-Q as percent of maximum (0 to 100%) calculated as Week 9 - baseline, where higher values indicate better quality of life.|Baseline to Week 9|All randomized patients who took at least one dose of study medication and had at least one post baseline assessment, with last observation carried forward to week 9 for patients who did not complete the study.||Percentage of Improvement||Standard Deviation|Least Squares Mean
729276|NCT00388973|Primary|Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to Week 9.|MADRS total score (0-60 units), where lower scores indicate less depressive symptoms, calculated as Week 9 value - baseline value.|Baseline to Week 9|All randomized patients who took at least one dose of study medication and had at least one post baseline assessment, with last observation carried forward to week 9 for patients who did not complete the study.||units on scale||Standard Deviation|Least Squares Mean
729277|NCT00389064|Secondary|Safety and Well Tolerated as Measured by Extra Pyramidal Symptoms (EPS)|Number of patients have adverse events associated with EPS|From start of the study teatment to last dose plus 30 days|Safety population||Patients|||Number
729278|NCT00389064|Secondary|Safety and Well Tolerated as Measured in Adverse Event|Number of patients have at least one adverse event|From the start of treatment to last dose plus 30 days|Safety population||Participants|||Number
729279|NCT00389064|Secondary|Change in the Visual Analogue Scale (VAS) Measuring Pain|Visual Analogue Scale (VAS) measuring pain (0-100 mm), 0 is best Change : scale at week 9 minus scale at randomization|Randomization to week 9|Modified Intent to Treat (MITT) population.||mm||Standard Deviation|Least Squares Mean
729280|NCT00389064|Secondary|Change in Montgomery-Asberg Depression Rating Scale (MADRS)|MADRS total score (0-60), 0 is best Change : score at week 9 minus score at randomization|Randomization to week 9|Modified Intent to Treat (MITT) population.||units on scale||Standard Deviation|Least Squares Mean
729281|NCT00389064|Secondary|Number of Patients Reaching Hamilton Rating Scale for Anxiety (HAM-A) Remission|"HAM-A remission, defined as HAM-A total score less or equal to 7. An indicator of HAM-A remission is calculated as:
If HAM-A total score≤7, THEN indicator=1
If HAM-A total score >7, THEN indicator=0"|Week 9|Modified Intent to Treat (MITT) population.||Number of participants.|||Number
729282|NCT00389064|Secondary|Hamilton Rating Scale for Anxiety (HAM-A) Response.|HAM-A response, defined as 50% or greater reduction from randomization in HAM-A total score.|Week 9|||Number of participants.|||Number
729283|NCT00389064|Secondary|Change in Somatic Symptoms as Measured by HAM-A Somatic Cluster Score|HAM-A somatic cluster score (0-28), 0 is the best Change : score at week 9 minus score at randomization|Randomization to Week 9|Modified Intent to Treat (MITT) population.||units on scale||Standard Deviation|Least Squares Mean
729284|NCT00389064|Secondary|Change in Psychic Anxiety Factor as Measured by HAM-A Psychic Cluster Score|HAM-A psychic cluster score ( 0-28), 0 is the best Change : score at week 9 minus score at randomization|Randomization to Week 9|Modified Intent to Treat (MITT) population.||units on scale||Standard Deviation|Least Squares Mean
729285|NCT00389064|Secondary|Change in the Clinical Global Impression - Severity of Illness (CGI-S) Score|CGI-S score is accessed on a seven-graded scale ranging from most extremely ill/ very much worse (7) to normal/very much improved (1) , 1 is best Change : score at week 9 minus score at randomization|Randomization to Week 9|Modified Intent to Treat (MITT) population.||units on scale||Standard Deviation|Least Squares Mean
729304|NCT00389207|Secondary|Time to Treatment Failure|Treatment failure is defined as the occurrence of the first of at least one of the following events: early discontinuation of trial drug, change in ARV therapy, failure to achieve an HIV RNA count < 50 copies/mL up to Visit 10 (week 48) or loss of virologic response|baseline to week 144|Full Analysis Set (FAS) defined as all randomized and treated patients but numbers are reduced as indicated due to empty cells in analyses adjusting for baseline categories||weeks||Inter-Quartile Range|Median
729286|NCT00389064|Secondary|Change in Health-related Quality of Life as Measured by Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Percent Maximum Total Score|"Q-LES-Q total score is the sum of the first 14 items of Q-LES-Q, and this total score is converted to a % maximum total score by : (Q-LES-Q total score -14) /56 x 100%, Larger values indicate a higher perceived quality of life enjoyment and satisfaction.
Change : percentage at week 9 minus percentage at randomization"|Randomization to Week 9|In reporting Q-LES-Q there was missing data even with last observation carried forward (LOCF), so the total number of patients analyzed is 428 ( 211 Quetiapine XR and 217 Placebo).||Percentage of Maximum Total Score||Standard Deviation|Least Squares Mean
729287|NCT00389064|Primary|Change in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score|HAM-A total score ( 0-56 units), 0 is the best, Change : score at week 9 minus score at randomization|Randomization to Week 9|Modified Intent to Treat (MITT) population.||units on scale||Standard Deviation|Least Squares Mean
729288|NCT00389168|Secondary|Effects on Carotid Artery Wall Thickness|Changes in common carotid artery intima-media thickness, assessed by ultrasonography.|Baseline to 48 weeks|||mm||Standard Deviation|Mean
729289|NCT00389168|Secondary|Changes of Venous Plasma Angiotensin II as a Marker of the Renin-Angiotensin-Aldosterone System|Venous plasma concentrations of angiotensin II were measured in order to study the possible associations between the activity of the renin-angiotensin-aldosteone system and changes in left ventricular mass. Further analyses of other components of the renin-angiotensin-aldosterone system and of other hormonal system (e.g. the sympathetic nervous system) have also been performed and published. Repeated measures MANOVA at time points 0, 12, 24, and 48 weeks. Data were log-transformed to avoid skewness before statistical evaluation. However, tabular data are given as mean values with 95% confidence to improve readability.|Baseline to 48 weeks|||pmol/L||95% Confidence Interval|Mean
729290|NCT00389168|Secondary|Blood Pressure|Difference in Diastolic Blood Pressure. Repeated measures multivariable analysis of variance (MANOVA) at time points 0, 12, 24, and 48 weeks|Baseline to 48 weeks|||mm Hg||95% Confidence Interval|Mean
729291|NCT00389168|Secondary|Left Ventricular Diastolic Function Assessed by the E/A Ratio|Changes in left ventricular diastolic function from baseline to week 48 will be evaluated as the difference in E/A ratio. Conventional pulsed wave Doppler echocardiography was used for recordings of mitral inflow in. The peak of early (E) and late (A) mitral flow velocities were measured, and the E/A-ratio was calculated. Repeated measures MANOVA at time points 0, 12, 24, and 48 weeks. Some echocardiographic recordings at some time point may be of insufficient quality or missing, and the number of observations may not always correspond to the total number of participants at all time points.|Baseline to 48 weeks|||ratio||Standard Deviation|Mean
729292|NCT00389168|Primary|Changes in Left Ventricular Mass Index|Repeated measures multivariate analysis of variance (MANOVA) at time points 0, 12, 24, and 48 weeks. Data are presented as left ventricular mass in gram (g) indexed for body mass index (in m^2).|Baseline and 48 weeks|Data on echocardiography is not always available at all time points and for all participants. This is reflected by the number of observations, which sometimes are less than the number of participants.||g/m^2||95% Confidence Interval|Mean
729293|NCT00389168|Secondary|Number of Participants With Serious Adverse Events|Safety was assessed by non-directed questions, and all observed and volunteered adverse events were recorded at each study visit. Serious adverse events were defined by, and reported according to the regulations of good clinical practice (GCP). none were considered related to the study medication.|Treatment period was baseline to 48 weeks|||Participants|||Number
729294|NCT00389207|Secondary|Change of Total Cholesterol to HDL-cholesterol Ratio From Baseline to Week 48, 96, 144|Change of Total cholesterol to HDL-cholesterol ratio from baseline to week 48, 96, 144|baseline to week 48, 96, 144|FAS, where only patients with corresponding laboratory values for the considered time point are considered||ratio||Standard Deviation|Mean
729295|NCT00389207|Secondary|Change of Total Triglycerides From Baseline to Week 48, 96, 144|Change of total triglycerides from baseline to week 48, 96, 144|baseline to week 48, 96, 144|FAS, where only patients with corresponding laboratory values for the considered time point are considered||mg/dL||Standard Deviation|Mean
729296|NCT00389207|Secondary|Change of hsCRP From Baseline to Week 48, 96, 144|Change of hsCRP from baseline to week 48, 96, 144|baseline to week 48, 96, 144|FAS, where only patients with corresponding laboratory values for the considered time point are considered||mg/L||Standard Deviation|Mean
729297|NCT00389207|Secondary|Changes of Apolipoprotein Values From Baseline to Week 48, 96, 144|Changes frombaseline apolipoprotein A1 & B|baseline to week 48, 96, 144|FAS, where only patients with corresponding laboratory values for the considered time point are considered||g/L||Standard Deviation|Mean
729298|NCT00389207|Secondary|Change of Cholesterol Values From Baseline to Week 48, 96, 144|Changes frombaseline in total cholesterol, LDL-cholesterol(LDL-c) and HDL|baseline to week 48, 96, 144|FAS, where only patients with corresponding laboratory values for the considered time point are considered||mg/dL||Standard Deviation|Mean
729299|NCT00389207|Secondary|Proportion of Patients Reporting CNS (Central Nervous System) Side Effects of Any Severity|Proportion of Patients reporting CNS (central nervous system) side effects of any severity|week 148|Full Analysis Set (FAS) defined as all randomized and treated patients.||participants|||Number
729300|NCT00389207|Secondary|Proportion of Patients Reporting Hepatic Events of Any Severity|Proportion of Patients reporting hepatic events of any severity|week 148|Full Analysis Set (FAS) defined as all randomized and treated patients.||participants|||Number
729301|NCT00389207|Secondary|Proportion of Patients Reporting Rash of Any Severity|Proportion of Patients reporting rash of any severity|week 148|Full Analysis Set (FAS) defined as all randomized and treated patients.||participants|||Number
729302|NCT00389207|Secondary|Proportion of Patients With >= DAIDS Grade 2 Laboratory Abnormalities||week 148|Full Analysis Set (FAS) defined as all randomized and treated patients.||participants|||Number
729303|NCT00389207|Secondary|Change in the Calculated Glomerular Filtration Rate (GFR) at Week 48, 96 and 144|Calculations based on the MDRD algorithm.|From baseline to Week 48, 96, 144|Full Analysis Set (FAS) defined as all randomized and treated patients but numbers are reduced as indicated due to empty cells in analyses adjusting for baseline categories||mL/min/1.73 m^2||Standard Deviation|Mean
729324|NCT00389207|Secondary|Proportion of Patients With VL < 400 Copies/ml|VL <400 copies/mL among observed patients on treatment at each visit, with the final visit at Week 144 or end of trial (EOT)|From baseline to Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144/EOT|FAS with varying numbers missing or not on treatment per visit||Proportion of patients|||Number
729305|NCT00389207|Secondary|Time to Loss of Virologic Response (Rebound)|Time to loss of virologic response (TLOVR) was defined as the time from start of treatment to the first measurement showing VL ≥ 50 copies/mL in the first virologic rebound, after having a confirmed virological response.|Baseline to week 144|Full Analysis Set (FAS) defined as all randomized and treated patients but numbers are reduced as indicated due to empty cells in analyses adjusting for baseline categories||weeks||Inter-Quartile Range|Median
729306|NCT00389207|Secondary|Time to Treatment Response (First Confirmed VL<50 Copies/mL)|Time to treatment response was defined as the time from start of treatment until the first measurement of the first confirmed virological response|baseline to week 144|Full Analysis Set (FAS) defined as all randomized and treated patients but numbers are reduced as indicated due to empty cells in analyses adjusting for baseline categories||weeks||Inter-Quartile Range|Median
729307|NCT00389207|Secondary|Proportion of Patients With Virologic Failure at Week 48, 96, 144||at Week 48, 96, 144|Full Analysis Set (FAS) defined as all randomized and treated patients but numbers are reduced as indicated due to empty cells in analyses adjusting for baseline categories||participants|||Number
729308|NCT00389207|Secondary|Proportion of Patients With Virological Rebound With VL >=400 Copies/mL After CVR at Week 24, 48, 96, 144|The analyses of virologic rebound were performed on the original values at each visit(ORGV) rather than calculated results within time windows (CAL)|at Week 24, 48, 96, 144|Full Analysis Set (FAS) defined as all randomized and treated patients.||participants|||Number
729309|NCT00389207|Secondary|Proportion of Patients With Virological Rebound With VL >=50 Copies/mL After CVR (Confirmed Virological Response) at Week 24, 48, 96, 144|The analyses of virologic rebound were performed on the original values at each visit(ORGV) rather than calculated results within time windows (CAL)|at Week 24, 48, 96, 144|Full Analysis Set (FAS) defined as all randomized and treated patients.||participants|||Number
729310|NCT00389207|Secondary|Treatment Response at Week 144|Treatment response is defined as a viral load (VL) <50 copies/mL measured at two consecutive visits prior to Week 144 and without subsequent rebound or change of antiretroviral (ARV) therapy prior to Week 144.|From baseline to Week 144|Full Analysis Set (FAS) defined as all randomized and treated patients but numbers are reduced as indicated due to empty cells in analyses adjusting for baseline categories.||participants|||Number
729311|NCT00389207|Secondary|Treatment Response at Week 96|Treatment response is defined as a viral load (VL) <50 copies/mL measured at two consecutive visits prior to Week 96 and without subsequent rebound or change of antiretroviral (ARV) therapy prior to Week 96.|From baseline to Week 96|Full Analysis Set (FAS) defined as all randomized and treated patients but numbers are reduced as indicated due to empty cells in analyses adjusting for baseline categories||participants|||Number
729312|NCT00389207|Secondary|Glycaemic Abnormalities|Number of patients with AE elevated serum glucose|From baseline to Week 144|FAS||Patients|||Number
729313|NCT00389207|Secondary|Serum Lipid Abnormalities|Number of patients with AE elevated serum lipids (i.e. hypercholesterolaemia)|From baseline to Week 144|FAS||patients|||Number
729314|NCT00389207|Secondary|Lipodystrophy|Number of patients with AE lipodystrophy|From baseline to Week 144|FAS||Patients|||Number
729315|NCT00389207|Secondary|Treatment-emergent AIDS-defining Illness Leading to Death|Patients with an AIDS-defining illness leading to death broken out by treatment. Statistical analysis shows time to death from AIDS-defining illness.|From baseline to Week 144|FAS||Patients|||Number
729316|NCT00389207|Secondary|Treatment-emergent AIDS-defining Illness|Treatment-emergent AIDS-defining illness (tr.-emerg. AIDS-def.illness) including worsening during treatment|From baseline to Week 144|FAS||Patients|||Number
729317|NCT00389207|Secondary|Genotypic Resistance Associated With Virologic Failure|Number of treatment-emergent drug-associated substitutions in patients with virological failure up to Week 48. The total number of genotypic mutations in those patients who were virologic failures is given, not the number of patients with mutations.|From baseline to Week 48|All patients with virologic failure assessed for genotypic resistance||Number of substitutions|||Number
729318|NCT00389207|Secondary|Non-scheduled Physician Visits|Cost effectiveness assessment by number of patients with non-scheduled physician visits|From baseline to Week 24, Week 24 to 48, Week 48 to 96, and Week 96 to 144/EOT|FAS with varying numbers missing||patients|||Number
729319|NCT00389207|Secondary|Number of Patients Hospitalized|Cost effectiveness assessment by number of patients hospitalized|From baseline to Week 24, Week 24 to 48, Week 48 to 96, and Week 96 to 144/EOT|FAS with varying numbers missing||Patients|||Number
729320|NCT00389207|Secondary|Change in Physical Health Summary (PHS) Score From Baseline|QoL assessment by change in PHS score from baseline to after 48, 96 and 144 weeks (observed cases), from the MOS-HIV, a 35-item self-administered questionnaire including 10 scales covering: health perceptions, pain, physical functioning, role functioning, social and cognitive functioning, mental health, energy/fatigue, health distress, and QoL. The PHS is a weighted average of the 10 scales and ranges from 0 to 100 with higher scores indicating better QoL.|From baseline to Weeks 48, 96 and 144/EOT|FAS with varying numbers missing||Units on a scale||Standard Deviation|Mean
729321|NCT00389207|Secondary|Change in Mental Health Summary (MHS) Score From Baseline|Quality of life (QoL) assessment by change in MHS score from baseline to after 48, 96 and 144 weeks (observed cases), from the Medical Outcomes Study HIV Health Survey (MOS-HIV), a 35-item self-administered questionnaire including 10 scales covering: health perceptions, pain, physical functioning, role functioning, social and cognitive functioning, mental health, energy/fatigue, health distress, and QoL. The MHS is a weighted average of the 10 scales and ranges from 0 to 100 with higher scores indicating better QoL.|From baseline to Weeks 48, 96 and 144/EOT|FAS with varying numbers missing||Units on a scale||Standard Deviation|Mean
729322|NCT00389207|Secondary|Change in Framingham Score From Baseline|Change in the estimated risk of cardiovascular disease using the Framingham algorithm from baseline to after 48, 96 and 144 weeks, last observation carried forward (LOCF). The score is based on age, gender, systolic blood pressure, total cholesterol, high density lipoprotein cholesterol and smoking status. Scores range from 0 to 21 with higher scores indicating a greater risk.|From baseline to Weeks 48, 96 and 144/EOT|FAS with varying numbers missing||Units on a scale||Standard Deviation|Mean
729323|NCT00389207|Secondary|Change in CD4+ Count From Baseline|Change in CD4+ cell count from baseline among patients on treatment at each visit, with the final visit at Week 144 or EOT|From baseline to Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144/EOT|FAS with varying numbers missing or not on treatment per visit||cells/mm^3||Standard Deviation|Mean
729325|NCT00389207|Secondary|Proportion of Patients With VL < 50 Copies/ml|VL <50 copies/mL among observed patients on treatment at each visit, with the final visit at Week 144 or end of trial (EOT) for the patient|From baseline to Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144/EOT|FAS with varying numbers missing or not on treatment per visit||Proportion of patients|||Number
729326|NCT00389207|Secondary|Treatment Response at Week 48 (TLOVR Algorithm)|Treatment response is defined as a VL <50 copies/mL measured at two consecutive visits up to Week 48 and without subsequent rebound or change of ARV therapy up to Week 48, based on time to loss of virologic response (TLOVR) algorithm, as a sensitivity analysis for the primary analysis.|From baseline to Week 48|FAS but numbers are reduced as indicated due to empty cells in analysis adjusting for baseline categories||Patients|||Number
729327|NCT00389207|Primary|Treatment Response at Week 48|Treatment response is defined as a viral load (VL) <50 copies/mL measured at two consecutive visits prior to Week 48 and without subsequent rebound or change of antiretroviral (ARV) therapy prior to Week 48.|From baseline to Week 48|Full Analysis Set (FAS) defined as all randomized and treated patients but numbers are reduced as indicated due to empty cells in analyses adjusting for baseline categories||Patients|||Number
729328|NCT00389324|Primary|Geometric Least Square Means of Area Under the Curve (AUC) for Plasma Total Immunoglobulin G (IgG)|Geometric least-squares mean of steady-state plasma concentration of total IgG vs. time profile (AUC).|IV Phase (21 or 28 days) at IV Visit #1, pre- and post-dose: 0 hr., 1 hr., and 1, 2, 3, 5, 7, 14, 21, and 28 days; SC Phase at Week #17, pre- and post-dose: 0 hr., and 1, 3, 4, 5, and 7 days|A total of 32 subjects in the IV phase and 26 subjects in the SC phase had sufficient plasma concentration of total IgG vs. time profiles (AUC) for assessment of steady-state PK parameters.||mg*hr/ml||Standard Deviation|Least Squares Mean
729329|NCT00389441|Secondary|Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score|Symptom interference score is comprised of average of 6 function items from MDASI core (general activity, mood, work, relations with others, walking, and enjoyment of life). Participants were asked to rate how much symptoms have interfered in last 24 hours; each item rated from 0 to 10, with 0 = did not interfere and 10 = interfered completely. Total average score range: 0 to 10. Lower scores indicated better outcome.|Baseline, Cycle 1 Day 15 (C1D15), C2D1, C2D15, thereafter D1 of each cycle up to 28 days after last dose (follow-up)|ITT population included all participants who were enrolled in the study and received at least 1 dose of study treatment. Here ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants evaluable at each time point.||units on a scale||Standard Deviation|Mean
729330|NCT00389441|Secondary|Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score|Symptom severity score is comprised of average of 13 MDASI core items (pain, fatigue, nausea, disturbed sleep, distressed, shortness of breath, remembering things, lack of appetite, drowsy, dry mouth, sadness, vomiting, numbness or tingling). Participants were asked to rate severity of each symptom at their worst in last 24 hours; each item rated from 0 to 10, with 0 = symptom not present and 10 = as bad as you can imagine. Total average score range: 0 to 10. Lower scores indicated better outcome.|Baseline, Cycle 1 Day 15 (C1D15), C2D1, C2D15, thereafter D1 of each cycle up to 28 days after last dose (follow-up)|ITT population included all participants who were enrolled in the study and received at least 1 dose of study treatment. Here ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants evaluable at each time point.||units on a scale||Standard Deviation|Mean
729331|NCT00389441|Secondary|Overall Survival (OS)|Time in weeks from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Baseline to death due to any cause or at least 2 year after the first dose for the last participant|ITT population included all participants who were enrolled in the study and received at least 1 dose of study treatment.||weeks||95% Confidence Interval|Median
729332|NCT00389441|Secondary|Duration of Response (DR)|Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Baseline until disease progression or initiation of antitumor therapy or death due to any cause, assessed every 8 weeks up to 28 days after last dose (follow-up)|Subgroup of participants from the ITT population, with a confirmed objective tumor response (CR or PR).||weeks||95% Confidence Interval|Median
729333|NCT00389441|Secondary|Progression Free Survival (PFS)|PFS: Time in weeks from the start of study treatment to first documentation of objective disease progression or to death due to any cause, whichever occurred first. PFS was calculated as (first event date minus the date of first dose of study treatment plus 1) divided by 7. Progression is defined using RECIST, as >=20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD since start of study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.|Baseline until disease progression or initiation of antitumor therapy or death due to any cause, assessed every 8 weeks up to 28 days after last dose (follow-up)|ITT population included all participants who were enrolled in the study and received at least 1 dose of study treatment.||weeks||95% Confidence Interval|Median
729334|NCT00389441|Primary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST). CR: disappearance of all target/non-target lesions and no appearance of new lesions. PR: at least (>=)30 percent(%) decrease in sum of the longest dimensions (LDs) of the target lesions (taking as a reference the baseline sum), without progression of non-target lesions and no appearance of new lesions. Confirmed responses: those persist on repeat imaging study >=4 weeks after initial documentation of response.|Baseline until disease progression or initiation of antitumor therapy or death due to any cause, assessed every 8 weeks up to 28 days after last dose (follow-up)|Intent-to-Treat (ITT) population included all participants who were enrolled in the study and received at least 1 dose of study treatment.||percentage of participants||95% Confidence Interval|Number
729335|NCT00389467|Secondary|Day 90 Mortality||at day 90|||participants|||Number
729336|NCT00389467|Secondary|Symptomatic Hemorrhagic Transformation|"Symptomatic intracranial hemorrhage is defined as 4 point neurologic worsening on the National Institutes of Health Stroke Scale (NIHSS) score associated with parenchymal hematoma type 2 (PH-2*), remote intracerebral hemorrhage, subarachnoid hemorrhage, or intraventricular hemorrhage on imaging. The NIHSS is a scale measuring specific neurologic deficits caused by a stroke with scores ranging from 0 to 42, and higher scores indicating more severe neurologic deficits.
*from the modified European Cooperative Acute Stroke Study (ECASS) II criteria"|from baseline to day 7|||participants|||Number
729337|NCT00389467|Primary|The Modified Rankin Scale Score|"Scale name is provided (Modified Rankin Scale) which is a standard measure of functional neurologic outcome in stroke. The scale runs from 0-6, running from perfect health without symptoms to death.
0 - No symptoms.
1 - No significant disability. Able to carry out all usual activities, despite some symptoms.
2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
3 - Moderate disability. Requires some help, but able to walk unassisted.
4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
6 - Dead."|at 90 days post-stroke|||units on a scale||95% Confidence Interval|Mean
729338|NCT00389493|Secondary|Brown Assessment of Beliefs (BABS)|"Scale ranges from 0 to 24 where 0 is beliefs are false and 24 is convinced beliefs = reality"|Week 0 and Week 8|||units on a scale||Standard Deviation|Mean
729339|NCT00389493|Secondary|Hamilton Depression Rating Scale (Ham-D)|Ham-D ranges from 0=no symptoms to 52 with higher numbers indicating more severe depression|Week 0 and Week 8|||units on a scale||Standard Deviation|Mean
729340|NCT00389493|Secondary|Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form|QLESQ ranges from 14-70, with higher scores meaning more enjoyment and satisfaction with quality of life|Week 0 and Week 8|||units on a scale||Standard Deviation|Mean
729341|NCT00389493|Secondary|Social Adjustment Scale-SR|SAS-SR yields a mean score between 1 and 5; the higher the score, the more severe the social adjustment problems|Week 0 and Week 8|||units on a scale||Standard Deviation|Mean
729342|NCT00389493|Primary|Score on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)|Y-BOCS ranges from 0-40, with 0 meaning no symptoms and higher numbers meaning greater symptom severity|Week 0 and Week 8|||units on a scale||Standard Deviation|Mean
729343|NCT00389519|Secondary|Change From Baseline to 4 Weeks in Schwartz Formula Glomerular Filtration Rate (GFR)|Value at end of treatment (up to 4 weeks) minus value at baseline; GFR is a measure of kidney function.|Baseline up to 4 weeks|Number of participants analyzed is less than number treated in the participant flow section because analysis includes only treated participants who had both a baseline and a post-baseline assessment; LOCF||mL/min per 1.73 m2||Standard Deviation|Mean
729344|NCT00389519|Secondary|Change From Baseline to 4 Weeks in Serum Potassium|Value at end of treatment (up to 4 weeks) minus value at baseline|Baseline up to 4 weeks|Number of participants analyzed is less than number treated in the participant flow section because analysis includes only treated participants who had both a baseline and a post-baseline assessment; LOCF||mg/dL||Standard Deviation|Mean
729345|NCT00389519|Secondary|Change From Baseline to 4 Weeks in Serum Creatinine|Value at end of treatment (up to 4 weeks) minus value at baseline|Baseline up to 4 weeks|Number of participants analyzed is less than number treated in the participant flow section because analysis includes only treated participants who had both a baseline and a post-baseline assessment; LOCF||mg/dL||Standard Deviation|Mean
729346|NCT00389519|Secondary|Change From Baseline to 4 Weeks in Trough Sitting Diastolic Blood Pressure|Value at end of treatment minus value at baseline, comparing the high-dose ramipril group with placebo|Baseline to 4 weeks|Intent to treat (ITT) analysis including only treated participants who had at least one post-baseline assessment (1 placebo patient was treated but had no post-baseline assessment); last observation carried forward (LOCF)||mm Hg||Standard Deviation|Mean
729347|NCT00389519|Primary|Change From Baseline to 4 Weeks in Trough Sitting Systolic Blood Pressure|Value at end of treatment minus value at baseline, comparing the high-dose ramipril group with placebo|Baseline to 4 weeks|Intent to treat (ITT) analysis including only treated participants who had at least one post-baseline assessment (1 placebo patient was treated but had no post-baseline assessment); last observation carried forward (LOCF)||mm Hg||Standard Deviation|Mean
729348|NCT00389532|Primary|Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition Antibodies Pre-vaccination and Post-vaccination|GMTs and their 95% confidence intervals for each of the 3 antigens in the Fluzone® vaccine (2006-2007 formulation) pre-vaccination and 21 days post-vaccination.|21 days post-vaccination|Geometric Mean Titers were evaluated in the per-protocol immunogenicity Population||Titer||95% Confidence Interval|Geometric Mean
729349|NCT00389532|Primary|Percentage of Participants With Solicited Injection Site or Systemic Reaction(s) After Fluzone® Vaccination|Percentage of Participants with Solicited Injection Site or Systemic Reaction(s) within 0-3 days after vaccination with Fluzone® (2006-2007 formulation)|0-3 days post-vaccination|Analysis was on all enrolled and vaccinated participants, Intend-to-treat population.||Percentage of Participants|||Number
729350|NCT00389597|Primary|Composite Definition of Study Success|"An individual subject in either treatment group was considered a success if the following criteria were met at 24 months:
Improvement in Neck Disability Index of at least 15/50 points in subjects with baseline Neck Disability Index scores of >= 30/50 points, or a 50% improvement in subjects with a baseline Neck Disability Score score of <30/50 where the Neck Disability Index is a measure designed to enable the physician to understand how much a subject's neck pain has affected his ability to manage everyday activities.
No study failures due to secondary surgical interventions at the index level
Absence of major complications defined as radiographic failure, neurologic failure, or failure by adverse event as adjudicated by the CEC"|2 Years|includes study failures, per protocol, that are carried forward for overall success||percentage of subjects analyzed|||Number
729351|NCT00389805|Secondary|Effect of Bortezomib on Over Expression of NF-kB, BCL-2, and BCL-xL (Phase II)|Tumor levels of BCL-2, BCL-xL and BAX will be assessed by immunohistochemistry (IHC).|Up to 36 months|The Phase II study was not conducted.|||||
729352|NCT00389805|Secondary|Importance of Folate-associated Gene Expression and Response or Outcome (Phase II)|Overexpression of reduced folate carrier (RFC) protein is thought to contribute to decreased resistance to pemetrexed. Levels of expression will be studied by measuring mRNA transcripts using quantitative Reverse Transcriptase-Polymerase Chain Reaction in archival patient tumor specimens.|Up to 36 months|The Phase II study was not conducted.|||||
729358|NCT00389805|Primary|Number of Patients Who Responded to Study Treatment (Phase II)|To determine the response rate of bortezomib in combination with pemetrexed in patients with advanced NSCLC. Response rate was assessed by CT scan. CT scans was performed at baseline and every two cycles (prior to 3rd and 5th cycle). The evaluation of response was based on standard RECIST criteria.|From start of treatment until disease progression/recurrence.|The Phase II study was not conducted.|||||
729359|NCT00389805|Primary|Number of Patients With Grade ≥ 3 Toxicity (Phase I)|Grade 3/4 toxicity occurring in a patient within 1 cycle.|First cycle of treatment (3 weeks)|||participants|||Number
729360|NCT00389805|Primary|Number of Participants Who Experience Adverse Events (Phase I)|Number of participants with treatment-related adverse events as assessed by CTCAE v3.0 (Phase I).|Throughout the entire study (up to 36 months).|||Participants|||Count of Participants
729361|NCT00389805|Primary|Number of Patients Experiencing a Dose-limiting Toxicity (Phase I)|Grade 4 thrombocytopenia or grade 3 thrombocytopenia associated with bleeding, requirement for transfusion or lasting >7 days; febrile neutropenia; grade 3 neutropenia associated with infection; any other grade >/=3 non-hematologic toxicity considered by the investigator to be related to study drug.|Up to 36 months|||Participants|||Count of Participants
729362|NCT00389818|Secondary|Event-free Survival at 1 Year||1 year post-treatment||||||
729363|NCT00389818|Secondary|Mortality and Cause of Death||At any time through the third year after treatment discontinuation||||||
729364|NCT00389818|Secondary|Relationship Between Development of Bacterial, Fungal, and/or Opportunistic Infections and Baseline CD4 Lymphocyte Count, HIV-1 RNA Level, and Quantitative Immunoglobin Level, or Changes in Quantitative Immunoglobin Levels Over Time||After every cycle of treatment, 1 month after treatment discontinuation, every 2 months for 1 year after treatment discontinuation, every 6 months during the second and third years after treatment discontinuation||||||
729365|NCT00389818|Secondary|Relationship Between Response and Survival and BCL-2 Expression in Tumor Tissue||Baseline, after cycles 4 and 6, 1 month after treatment discontinuation||||||
729366|NCT00389818|Secondary|Relationship Between MDR-1 Expression and Response to Treatment||Baseline||||||
729367|NCT00389818|Primary|Rate of Bacterial, Fungal, and Opportunistic Infections||After every cycle of treatment, 1 month after treatment discontinuation, every 2 months for 1 year after treatment discontinuation, every 6 months during the second and third years after treatment discontinuation||||||
729368|NCT00389818|Primary|Median Survival Time||After cycles 2, 4, 6, 1 month after treatment discontinuation, every 2 months for 1 year after treatment discontinuation, every 6 months during the second and third years after treatment discontinuation||||||
729369|NCT00389818|Primary|Duration of Response||After cycles 2, 4, 6, 1 month after treatment discontinuation, every 2 months for 1 year after treatment discontinuation, every 6 months during the second and third years after treatment discontinuation||||||
729370|NCT00389818|Primary|Complete Response Rate (Complete Response and Complete Response Unconfirmed) Defined as Disappearance of All Evidence of Disease Based on Radiographic Findings on CT or MRI .||After cycles 2, 4, 6, 1 month after treatment discontinuation, every 2 months for 1 year after treatment discontinuation, every 6 months during the second and third years after treatment discontinuation|||proportion of patients||95% Confidence Interval|Number
729371|NCT00389831|Primary|Average PLMWI (Periodic Leg Movement Index During Wakefulness) After Single Dose of Rotigotine Nasal Spray or Matching Placebo.|The Periodic Limb Movement (PLM) during Wakefulness Index (PLMWI) measures the number of limb movements per hour and indicates the frequency of PLMs when the subject is awake and the degree of motor symptoms of the disorder during wake time. No movements would result in a score of 0 PLM per hour. Outcome is the average movements per hour in the 4 hour post-dose period per subject.|4 hours post-treatment period at each treatment day|Full Analysis Set||PLM per hour||Standard Deviation|Mean
729372|NCT00389831|Primary|Average Numeric Symptom Severity Score After Single Dose of Rotigotine Nasal Spray or Matching Placebo|Subjects rate the severity of the RLS symptoms at the start of each pre dose and post dose Suggested Immobilization Test (SIT-0 to SIT-6) and every 5min during each SIT, using a numeric symptoms severity scale, where 0=not severe and 10=very severe.|4 hours post-treatment period at each treatment day|Full Analysis Set||score on a scale||Standard Deviation|Mean
729373|NCT00389857|Other Pre-specified|Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 2.|"Solicited injection site reactions: Erythema, swelling, tenderness for infants/toddlers, and pain for children Solicited systemic reactions: For infants/toddler: fever (temperature), irritability, abnormal crying, drowsiness, lost appetite, vomiting; For children: fever (temperature), headache, malaise, myalgia).
Note: Influenza vaccine-primed group did not receive vaccination 2"|0 to 3 days post-vaccination 2|"Safety analysis was on all enrolled and vaccinated participants, intend to treat population.
Influenza vaccine-primed group did not received vaccination 2"||Participants|||Number
729374|NCT00389857|Other Pre-specified|Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1.|Solicited injection site reactions: Erythema, swelling, tenderness for infants/toddlers, and pain for children Solicited systemic reactions: For infants/toddler: fever (temperature), irritability, abnormal crying, drowsiness, lost appetite, vomiting; For children: fever (temperature), headache, malaise, myalgia).|0 to 3 days post-vaccination 1|Safety analysis was on all enrolled and vaccinated participants, intent-to-treat population||Participants|||Number
729375|NCT00389857|Primary|Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies Before and After Fluzone® Vaccination|"GMTs and their 95% Confidence Interval are presented for each of the 3 antigens in the Fluzone vaccine 2006-2007 Pediatric formulation.
Post-dose 1 (Influenza vaccine-primed group); Post-dose 2 (Influenza vaccine-naive group)"|14 days post-vaccination|Geometric mean titers were evaluated in the per-protocol population.||Titer||95% Confidence Interval|Geometric Mean
729376|NCT00389974|Primary|Objective Response Rate (PR or CR)|It is defined as per the Response Evaluation Criteria In Solid Tumors criteria for at least 4 weeks. The 95% confidence interval for response rate will be calculated.|Up to 2 years|All patients evaluable for response||percentage of evalubale patients||95% Confidence Interval|Number
729377|NCT00390013|Primary|Change From Baseline in Vulvar Pain|change in vulvar pain following gabapentin compared to placebo - will evaluate the efficacy of gabapentin to decrease vulvar pain compared to placebo. end of 1st treatment (after 8 weeks) and end of 2nd treatment (after 19 weeks). Pain was assessed using ordinal scale (0-10): 0 = no pain, 10 = most severe pain.|19 weeks|study terminated early due to poor recruitment||units on a scale||Full Range|Mean
729380|NCT00390182|Primary|Overall Response|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|3 weeks|||participants|||Number
729381|NCT00390221|Secondary|Mean Change From Baseline in Multiple Sclerosis Impact Scale (MSIS)-29 Physical Impact Score at Week 52|The 29-item Multiple Sclerosis Impact Scale (MSIS-29) is a disease specific patient-reported outcome measure that has been developed and validated to examine the physical and psychological impact of MS from a patient’s perspective; it measures 20 physical items and 9 psychological items. Responses use a 5 point Likert scale range from 1 to 5. All questions are to be answered. The total score is the sum of points for all 29 questions, with a minimum score of 29, and a maximum score of 145. A lower total score indicates less physically-related impact while a higher total score indicates greater physically-related impact on a subject's functioning.|Baseline and Week 52|Intent to treat population: all randomized subjects who received at least 1 dose of study medication (excluding 21 subjects from a single site due to a protocol violation in dosing).||units on a scale||Standard Deviation|Mean
729382|NCT00390221|Secondary|Proportion of Participants Who Relapsed at Week 52|Estimated cumulative proportion of participants relapsed at Week 52, based on the Kaplan-Meier product limit method. Only relapses confirmed by the Independent Neurology Evaluation Committee were included in the analysis.|Week 52|Intent to treat population: all randomized subjects who received at least 1 dose of study medication (excluding 21 subjects from a single site due to a protocol violation in dosing). Participants who did not experience a relapse prior to switching to alternative MS medications or withdrawal from study were censored.||proportion of participants|||Number
729383|NCT00390221|Secondary|Adjusted Mean Number of New or Newly-enlarging T2 Hyperintense Lesions at Week 52|Lesions detected on T2-weighted sequences represent a range of histopathology related to MS, including edema, inflammation, demyelination, gliosis, and axon loss.|Week 52|Intent to treat population: all randomized subjects who received at least 1 dose of study medication (excluding 21 subjects from a single site due to a protocol violation in dosing) with a non-missing value at baseline.||lesions||95% Confidence Interval|Mean
729384|NCT00390221|Secondary|Adjusted Mean Number of New Gadolinium (Gd)-Enhancing Lesions Between Week 8 and Week 24|Gd-enhancing lesions are detected when Gd leaks into a perivascular space due to local breakdown of the blood-brain barrier, indicating the presence of active inflammation. For participants with missing data the last valid nonbaseline measurement was carried forward if the participant was missing only 1 or 2 consecutive postbaseline scans. Otherwise the mean based on treatment group and visit was used as the imputed value. Estimated from a negative binomial model adjusted for the baseline number of Gd-enhancing lesions.|Week 8 through Week 24|Magnetic Resonance Imaging (MRI) Intensive Population: a protocol-defined subset of participants consisting of the first 307 participants enrolled in the study with non-missing baseline values.||lesions||95% Confidence Interval|Mean
729385|NCT00390221|Primary|Adjusted Annualized Relapse Rate Between Baseline and Week 52|Relapses are defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the examining neurologist. The annualized relapse rate was calculated as the total number of relapses that occurred during the study divided by the total number of subject-years followed in the study.|Baseline through Week 52|Intent to treat population: all randomized participants who received at least 1 dose of study medication (excluding 21 participants from a single site due to a protocol violation in dosing).||relapses per person-years||95% Confidence Interval|Number
729386|NCT00390234|Secondary|Survival (Carcinosarcoma Group)|Survival statistics will be estimated using the Kaplan-Meier method. Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. 95% confidence intervals will be provided for estimates of interest where possible.|Up to 3 years|||months||95% Confidence Interval|Median
729387|NCT00390234|Primary|Incidence of Disease Stabilization, as Measured by Progression-free Survival at 6 Months (Carcinosarcoma Group)||6 months|||months||95% Confidence Interval|Median
729388|NCT00390234|Secondary|Survival (Leiomyosarcoma Group)|Survival statistics will be estimated using the Kaplan-Meier method. Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. 95% confidence intervals will be provided for estimates of interest where possible.|Up to 3 years|||months||95% Confidence Interval|Median
729389|NCT00390234|Primary|Incidence of Disease Stabilization, as Measured by Progression-free Survival at 6 Months (Leiomyosaroma Group)||6 months|||months||95% Confidence Interval|Median
729390|NCT00390234|Primary|Objective Response Rate, Evaluated According to the RECIST Criteria||Up to 3 years|||participants|||Number
729391|NCT00390364|Primary|Response Rate: The Total Number of Participants With Progression of Disease|"To determine response rate and time to tumor progression of patients with colorectal cancer and mutations in the PI3KCA gene who are treated with RAD001. Response and progression will be evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions assessed by CT (or MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesion. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesion.
The outcome measure will be the total number of subjects who show progression of disease."|1 month|||participants with progression of disease|||Number
729392|NCT00390416|Primary|1-year Survival||1 year|||months||95% Confidence Interval|Median
729393|NCT00390416|Secondary|Patients With Measurable Disease the Confirmed Response Rate||up to 2 years|||percentage of participants||95% Confidence Interval|Number
729394|NCT00390416|Primary|6 Month Progression Free Survival|as measured from the start of the treatment to the date of either documentation of disease progression or death. As we have previously, we will define progression of disease as per RECIST criteria. As per RECIST criteria, any evidence of progression in non-measurable lesions, measurable lesions, or the development of new lesions, would qualify as disease progression .RECIST criteria as defined by CTEP (http://ctep.info.nih.gov/Policies).|6 months|||percentage of participants||95% Confidence Interval|Number
729395|NCT00390455|Other Pre-specified|Objective Tumor Response Rate for Participants With HER2-positive Tumors|Response was defined by the RECIST. A responding participant had either a Complete Response (disappearance of all target lesions) or Partial Response (30% decrease in sum of longest diameter of target lesions). The response rate of measurable tumors will be estimated with its 95% confidence interval according to treatment arm.|Up to 5 years|Participants who started protocol therapy, had measurable disease and HER-2 positive disease were analyzed.||percentage of participants||95% Confidence Interval|Number
729396|NCT00390455|Other Pre-specified|Objective Tumor Response Rate for Participants With HER2-negative Tumors|Response was defined by the RECIST. A responding participant had either a Complete Response (disappearance of all target lesions) or Partial Response (30% decrease in sum of longest diameter of target lesions). The response rate of measurable tumors will be estimated with its 95% confidence interval according to treatment arm.|Up to 5 years|Participants who started protocol therapy, had measurable disease and HER-2 negative disease were analyzed.||percentage of participants||95% Confidence Interval|Number
729397|NCT00390455|Other Pre-specified|Progression-free Survival for Participants With HER2-positive Tumors|PFS was defined as the interval from study entry until disease progression or death resulting from any cause, whichever occurred first.|Up to 5 years|Participants who started protocol therapy and had HER2-positive disease were analyzed.||months||95% Confidence Interval|Median
729398|NCT00390455|Other Pre-specified|Progression-free Survival for Participants With HER2-negative Tumors|PFS was defined as the interval from study entry until disease progression or death resulting from any cause, which ever occurred first.|Up to 5 years|Participants who began protocol therapy with HER-2 negative tumors were analyzed.||months||95% Confidence Interval|Median
729399|NCT00390455|Secondary|Overall Survival (OS)|Overall survival was measured as the interval from study entry until death, from any cause, or last contact.|Study entry to death or last follow-up, up to 5 years|4 participants who never started protocol therapy were excluded.||months||95% Confidence Interval|Median
729400|NCT00390455|Secondary|Objective Tumor Response Rate|Response was defined by the Response Evaluation Criteria in Solid Tumors (RECIST). A responding participant had either a Complete Response (disappearance of all target lesions) or Partial Response (30% decrease in sum of longest diameter of target lesions). The response rate of measurable tumors will be estimated with its 95% confidence interval according to treatment arm.|Up to 5 years|Participants who started protocol therapy and had measurable disease were evaluated.||percentage of participants||95% Confidence Interval|Number
729401|NCT00390455|Primary|Progression-free Survival (PFS)|PFS was defined as the interval from study entry until disease progression or death resulting from any cause, which ever occurred first. Progression is defined as a 20% increase in the sum of longest diameter of target lesions (per RECIST criteria).|Interval from randomization until disease progression or death, whichever occurs first, assessed up to 5 years|4 participants who never received protocol therapy were excluded.||months||95% Confidence Interval|Median
729402|NCT00390468|Primary|8-week Freedom-From-Progression (FFP)|Simon 2 stage design for freedom from progression at 8 weeks where time-to-progression defined as time of initiation of therapy to first determination of progression of disease by clinical, radiological or serological criteria: Frequency of p-PDGFR (phosphorylated platelet-derived growth factor receptor) expression in bone marrow biopsy specimens, prostate-specific antigen (PSA) declines by 50% sustained for 4 weeks, measurable disease outcomes by RECIST (Response Evaluation Criteria In Solid Tumors) criteria, and quantitative/qualitative toxicities assessed.|8 weeks; repeat assessments performed every 8 weeks after criteria for response first met.|Analysis was per protocol; Of 18 participants, only 15 were evaluable for efficacy.||participants|||Number
729403|NCT00390546|Secondary|Incidence of Adverse Outcomes in Infants With Propranolol or Digoxin|In relation to the study drugs|12 months|||participants|||Number
729404|NCT00390546|Secondary|Number of Treated Patients Experiencing First SVT Recurrence|Infants treated with propranolol or digoxin|up to 110 days of treatment|||participants|||Number
729405|NCT00390546|Primary|Incidence of Recurrent Supraventricular Tachycardia (SVT) Requiring Medical Intervention to Terminate the Episode.||6 months or until study endpoints were reached|||percentage of participants|||Number
729406|NCT00390559|Primary|Subjective Effects|"The full scale name is the Urge to smoke visual analog scale (VAS). It measures self-reported urge to smoke. As with any VAS a word or phrase (in this case, Urge to Smoke is centered over a horizontal line anchored on the left by “not at all” and on the right by “extremely.” In this study, participants used a mouse to produce a vertical mark on the horizontal line, and the score was the distance of the mark from the left anchor expressed as a percentage of total line length. Thus, the minimum was 0 (“not at all”) and the maximum score was 100 (“extremely”)."|6 hours|"Those who completed all four arms of the crossover study."||units on a scale||Standard Deviation|Mean
729407|NCT00390572|Primary|Sleep Quality|Changes in overall sleep quality were evaluated using the Pittsburgh Sleep Quality Index (PSQI). The PSQI is a self-rating scale that yields a quantitative index of general sleep quality/disturbances. The PSQI is composed of 4 open-ended questions and 19 self-rated items (0-3 scale) assessing sleep quality and disturbances over a 1-month interval. The PSQI yields a global score of sleep quality ranging from 0 to 21. A score of <= 5 on the PSQI is considered normal sleep quality.|10 Months|Data from all participants were included in analyses.||units on a scale||Standard Deviation|Mean
729408|NCT00390572|Primary|Sleep Efficiency|Changes in sleep from baseline to subsequent follow-up periods were evaluated using both actigraphy and electronic diaries via a personal digital assistant (PDA). Primary outcome measures derived from the PDA included total sleep time (TST), total wake time (TWT: SOL+WASO), and sleep efficiency (SE). Wrist Actigraphy. Mini-Mitter® Actiwatch actigraphs were used to derive the primary objective estimates of TST, TWT, and SE. Mean values of TST, TWT and SE were obtained for each participant at baseline, 5 months and 10 months post-randomization and served as the actigraphic dependent measures in study analyses.|10 Months after Baseline|Data from all participants was included.||percentage of time in bed spent sleeping||Standard Deviation|Mean
729409|NCT00390572|Secondary|Sleepiness|Changes in subjectively assessed daytime sleep propensity were measured using the Epworth Sleepiness Scale (ESS), a commonly employed in both sleep research and clinical applications. The ESS items inquire about the chance of dozing off in each 8 different situations. Responses are rated on a 4 point scale reflecting the respondents perceived likelihood of falling asleep. To quanitfy this outcome, the percentage of participants achieving normal sleep (less than 10 on ESS) was compared across arms at 10 months.|10 months|||percentage of participants|||Number
729410|NCT00390572|Primary|Diary Sleep: Total Wake Time and Total Sleep Time|Changes in sleep from baseline to subsequent follow-up periods were evaluated using both actigraphy and electronic diaries via a personal digital assistant (PDA). Primary outcome measures derived from the PDA included total sleep time (TST), total wake time (TWT: SOL+WASO), and sleep efficiency (SE). Wrist Actigraphy. Mini-Mitter® Actiwatch actigraphs were used to derive the primary objective estimates of TST, TWT, and SE. Mean values of TST, TWT and SE were obtained for each participant at baseline, 5 months and 10 months post-randomization and served as the actigraphic dependent measures in study analyses.|10 months|||minutes||Standard Deviation|Mean
729411|NCT00390572|Primary|Provider Adherence to Sleep Specialist Recommendations|Provider outcomes included the provider’s number of participant sleep lab referrals, referrals to other specialty clinics for evaluation/treatment participant sleep problems, and presence of newly initiated sleep-focused therapies for participants. Information about these outcomes was obtained via review of provider orders and information included in notes entered into the VA’s computerized medical record system (CPRS). To quantify this outcome, the number of participants referred by providers for sleep-focused diagnostic tests and interventions was compared across arms.|10 months after baseline|Data was included for all participants.||participants|||Number
729412|NCT00390611|Secondary|Toxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/Sorafenib|Number of patients experiencing treatment-related adverse events|18 months|||participants|||Number
729413|NCT00390611|Secondary|Overall Survival (OS)|Overall survival was measured from the date of study entry until the date of death|18 months|||months||95% Confidence Interval|Median
729414|NCT00390611|Secondary|Overall Response Rate (ORR)|Number of patients with either complete response (CR) or partial response (PR) as defined in Response Evaluation Criteria in Solid Tumors (for patients with measurable disease) or determined by CA-125 levels (for patients without measurable disease). Complete Response: Disappearance of all target lesions, disappearance of all non-target lesions, and normalization of CA-125 for at least 4 weeks. In patients who have only elevated CA-125, the CA-125 must normalize (< 23U/mL) for more than 4 weeks. Partial Response: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters. For patients with elevated CA-125 only, partial response will be defined as a > 50% decrease in the serum CA-125 level.|18 months|||participants|||Number
729415|NCT00390611|Primary|2-year Progression-free Survival|The proportion of patients with progression-free survival at 2 years. Progression-free survival is measured from Day 1 of study drug administration to disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death on study. Progression is defined in RECIST v1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|2 years|||percentage of participants|||Number
729416|NCT00390689|Secondary|Possible Augmentation in RLS Symptoms at 52 Weeks for Open-Label Period|Possible augmentation defined as persistence of a state in which RLS symptoms begin to occur 2 hours earlier than the usual time zone for 5 days or more a week|baseline to week 52|Full Analysis Set (FAS).||Percentage of patients|||Number
729417|NCT00390689|Secondary|Patient Global Impression (PGI) Responder at 52 Weeks for Open-Label Period|PGI is used to evaluate a global impression by patients themselves in 7 ranks. Rating scale from 1 (very much better) to 7 (very much worse). The percentage of patients where the patient evaluated himself/herself as 1(very much better) or 2(much better)were considered responders.|baseline to week 52|Full Analysis Set (FAS).||Percentage of patients|||Number
729418|NCT00390689|Secondary|Clinical Global Impression Global Improvement (CGI-I) Responder at 52 Weeks for Open-label Period|CGI is extensively used for risk-benefit evaluation (efficacy) of drug therapies. The CGI evaluates the severity and improvement in 7 ranks. It also evaluates the therapeutic effect and side effects in 4 ranks, separately. Rating scale from 1 (very much improved) to 7 (very much worse). The percentage of patients who were evaluated as 1(very much improved) or 2(much improved) by the investigator were considered responders.|baseline to week 52|Full Analysis Set (FAS).||Percentage of patients|||Number
729419|NCT00390689|Secondary|Change From Baseline in Japanese Version of the Epworth Sleepiness Scale (JESS) Total Score at 52 Weeks for Open-Label Period|ESS is a self-recording scale used to evaluate sleepiness experienced in daily activities and it consists of 8 items focused on specific situations such as reading books and watching television. Each score (0-3 points) to 8 questions was added simply to calculate the total ESS score. A Japanese translation of the ESS (a provisional version provided by the Japanese Respiratory Society) used so far had not been prepared through the international scale development and validation process, but the version prepared through this process was published at the 31st meeting of the Japanese Society of Sleep Research. The questions in JESS had been discussed with the original author of the ESS and their measurement concepts had been confirmed. The JESS is the Japanese version of ESS prepared through the international scale development and validation process. Rating scale scored from 0 (no daytime sleep) to 24 (worst daytime sleep)|Week 52 - change from baseline|Full Analysis Set (FAS).||Points on a scale||Standard Deviation|Mean
729420|NCT00390689|Secondary|Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Score at 52 Weeks for Open-Label Period|PSQI developed to evaluate the quality of sleep is a self-recording questionnaire consisting of 18 questions focused on 7 factors such as sleep quality, sleep period time, sleep latency, sleep efficiency, sleep difficulty, use of hypnotics, and hindrance to activities of daily living due to daytime sleepiness. Each score (0-3 points) in the respective factors was added to calculate the total score (0-21 points). Rating scale scored from 0 (best sleep) to 21 (worst sleep).|Week 52 - change from baseline|Full Analysis Set (FAS).||Points on a scale||Standard Deviation|Mean
729421|NCT00390689|Secondary|IRLS Responder for Open-label Period|The percentage of patients with 50 % or more reduction of IRLS (The measure means the percentage of high responder on the trial medications)|baseline to week 52|Full Analysis Set (FAS).||Percentage of patients|||Number
729422|NCT00390689|Secondary|Change From Baseline in International Restless Legs Syndrome (IRLS) Total Score at 52 Weeks for Open-Label Period|The International Restless Legs Syndrome Study Group (IRLSSG) proposes classification of severity based on the total score on the IRLS (0-10, mild; 11-20, moderate; 21-30, severe; 31-40, very severe).|Week 52 - change from baseline|Full Analysis Set (FAS).||Points on a scale||Standard Deviation|Mean
729423|NCT00390689|Secondary|Clinically Significant Abnormalities in Vital Signs (Blood Pressure and Pulse Rate in Both Supine and Standing Positions), ECG, Laboratory Tests - Double Blind Period.||baseline to 6 weeks|||participants|||Number
729424|NCT00390689|Secondary|Patient Global Impression (PGI) Responder|PGI is used to evaluate a global impression by patients themselves in 7 ranks. Rating scale from 1 (very much better) to 7 (very much worse). The percentage of patients where the patient evaluated himself/herself as 1(very much better) or 2(much better)were considered responders.|baseline to week 6|Full Analysis Set (FAS).||Percentage of patients|||Number
729425|NCT00390689|Secondary|Clinical Global Impression Global Improvement (CGI-I) Responder|CGI is extensively used for risk-benefit evaluation (efficacy) of drug therapies. The CGI evaluates the severity and improvement in 7 ranks. It also evaluates the therapeutic effect and side effects in 4 ranks, separately. Rating scale from 1 (very much improved) to 7 (very much worse). The percentage of patients who were evaluated as 1(very much improved) or 2(much improved) by the investigator were considered responders.|baseline to week 6|Full Analysis Set (FAS).||Percentage of patients|||Number
729426|NCT00390689|Secondary|Change From Baseline in Japanese Version of the Epworth Sleepiness Scale (JESS) Total Score at 6 Weeks|ESS is a self-recording scale used to evaluate sleepiness experienced in daily activities and it consists of 8 items focused on specific situations such as reading books and watching television. Each score (0-3 points) to 8 questions was added simply to calculate the total ESS score. A Japanese translation of the ESS (a provisional version provided by the Japanese Respiratory Society) used so far had not been prepared through the international scale development and validation process, but the version prepared through this process was published at the 31st meeting of the Japanese Society of Sleep Research. The questions in JESS had been discussed with the original author of the ESS and their measurement concepts had been confirmed. The JESS is the Japanese version of ESS prepared through the international scale development and validation process. Rating scale scored from 0 (no daytime sleep) to 24 (worst daytime sleep)|Week 6 - change from baseline|Full Analysis Set (FAS).||Points on a scale||Standard Error|Least Squares Mean
729427|NCT00390689|Secondary|Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Score at 6 Weeks|PSQI developed to evaluate the quality of sleep is a self-recording questionnaire consisting of 18 questions focused on 7 factors such as sleep quality, sleep period time, sleep latency, sleep efficiency, sleep difficulty, use of hypnotics, and hindrance to activities of daily living due to daytime sleepiness. Each score (0-3 points) in the respective factors was added to calculate the total score (0-21 points). Rating scale scored from 0 (best sleep) to 21 (worst sleep).|Week 6 - change from baseline|Full Analysis Set (FAS).||Points on a scale||Standard Error|Least Squares Mean
729428|NCT00390689|Secondary|IRLS Responder|The percentage of patients with 50 % or more reduction of IRLS (The measure means the percentage of high responder on the trial medications)|baseline to week 6|Full Analysis Set (FAS).||Percentage of patients|||Number
729429|NCT00390689|Primary|Change From Baseline in International Restless Legs Syndrome (IRLS) Total Score at 6 Weeks|The International Restless Legs Syndrome Study Group (IRLSSG) proposes classification of severity based on the total score on the IRLS (0-10, mild; 11-20, moderate; 21-30, severe; 31-40, very severe). A decrease in the score of the IRLS by 10 or more points corresponds to the improvement of severity by one rank and has clinical importance. Therefore, the primary endpoint in the double-blind period was set as a decrease by 10 or more points in the mean change on the total score of the IRLS from the baseline to Visit 5 (last observation day in the double-blind period) at all doses of 0.25 mg, 0.5 mg, and 0.75 mg/day of pramipexole.|Week 6 - change from baseline|Full Analysis Set (FAS).||Points on a scale||Standard Error|Least Squares Mean
729430|NCT00390780|Secondary|Treatment Compliance|Number of patients who were 100% compliant with the treatment regimen|Initiation of treatment to Day 14|ITT (all randomized patients who took at least 1 dose of study medication)||participants compliant|||Number
729431|NCT00390780|Secondary|Susceptibility of Candida Species by Microdilution Test|minimum inhibitory concentration (MIC) in nonresponders at test-of-cure visit|Initiation of treatment to Day 17 to 22|ITT (all randomized patients who took at least 1 dose of study medication), nonresponders (participants with progression to a higher visible lesion extent score or no reduction in oral lesion extent score at the test of cure [Day 17 to 22] visit)||mcg/ml||Standard Deviation|Mean
729432|NCT00390780|Secondary|Systemic Exposure of Miconazole Lauriad 50 mg Bioadhesive Buccal Tablet|Number of patients with detectable plasma concentration at Visit 3 (day 7)|7 days|ITT (all randomized patients who took at least 1 dose of study medication)||participants|||Number
729433|NCT00390780|Secondary|Duration of Adhesion of Miconazole Lauriad 50 mg Mucoadhesive Buccal Tablet|The mean durations of adhesion from initiation of treatment to Day 14 of miconazole Lauriad 50 mg mucoadhesive buccal tablet (or, in the case of the Clotrimazole troches treatment arm, the placebo mucoadhesive buccal tablet) were rounded to the nearest hour|14 days|ITT (all randomized patients who took at least 1 dose of study medication)||hours||Full Range|Mean
729434|NCT00390780|Secondary|General and Local Tolerability and Oral Discomfort|Overall local adverse reactions, including gingival inflammation, gum pain, alterations in taste of food when eating, alterations in taste when not eating, and dry mouth. Visit 4 occurred on Day 14.|14 days|Safety Population (same as ITT population, includes all randomized patients who took at least one dose of the study medication)||participants|||Number
729435|NCT00390780|Secondary|Oral Discomfort Using Visual Analog Scale (VAS)|Visual analog scale was used by the patient in the patient diary. The scale ranged from 0 (no oral discomfort) to 10 (maximum oral discomfort)|14 days|Intent-to-Treat (ITT, all randomized patients who took at least 1 dose of study medication)||units on a scale||Full Range|Mean
729436|NCT00390780|Secondary|Relapse at the Late Post-Therapy Visit (Day 35-38)|"Number of patients represents the number of participants who completed visit 6 (the late post-therapy visit on Days 35-38) and had been a clinical success at test-of-cure visit (visit 5). For this subset of participants, relapse was defined as a patient who responded to treatment by clinical cure or improvement (i.e., clinical success) on Days 17-22 at the test-of-cure visit (visit 5) and subsequently had an increase in the extent of oral lesions or symptoms, as assessed at the late post-therapy visit on Days 35-38 (visit 6). No relapse indicates participants who were considered a clinical success at visit 5 and did not have a subsequent increase in the extent of oral lesions or symptoms, as assessed at the late post-therapy visit (visit 6). The remaining number of participants in the Intent-to-Treat population who did not meet the criteria for relapse assessment at visit 6 is listed under Not Analyzed-ITT."|35 to 38 days|"ITT (all randomized patients who took at least 1 dose of study medication)
PP (all patients in ITT without major protocol deviation, with positive fungal culture, completed at least 10 days of treatment, had main efficacy criteria at test of cure, compliant within 71.4% to 120%, and no forbidden medications taken)"||participants|||Number
729437|NCT00390780|Secondary|Mycological Cure at the Test of Cure Visit (Day 17-22)|"Mycological cure was defined as a patient who had no yeast isolated when oral specimens were cultured for fungi."|17 to 22 days|"ITT (all randomized patients who took at least 1 dose of study medication)
PP (all patients in ITT without major protocol deviation, with positive fungal culture, completed at least 10 days of treatment, had main efficacy criteria at test of cure, compliant within 71.4% to 120%, and no forbidden medications taken)"||participants|||Number
729438|NCT00390780|Secondary|Partial Response at Test of Cure Visit (Days 17-22) Using Murray Scoring Scale|Murray scoring scale range: extent of oral lesions (signs) 0 (none) to 3 (extensive or confluent), ordinal; symptoms (soreness/burning) 0 (absent) to 3 (severe), ordinal. Clinical success was defined as clinical cure or clinical improvement. Partial response is having decrease in Murray extent of oral lesions score by at least 1 level and a stable Murray symptoms score, with partial symptom response defined as having a decrease in the Murray symptoms (soreness/burning) score by at least 1 level and a stable Murray extent of oral lesions score, and partial clinical/symptom response defined as decrease in Murray extent of oral lesions score by at least 1 level and a decrease in the Murray symptoms (soreness/burning) score by at least 1 level|17 to 22 days|"ITT (all randomized patients who took at least 1 dose of study medication)
PP (all patients in ITT without major protocol deviation, with positive fungal culture, completed at least 10 days of treatment, had main efficacy criteria at test of cure, compliant within 71.4% to 120%, and no forbidden medications taken)"||participants|||Number
729439|NCT00390780|Secondary|Clinical Success at Day 7 (Using Murray Scoring Scale)|Murray scoring scale range: extent of oral lesions (signs) 0 (none) to 3 (extensive or confluent), ordinal; symptoms (soreness/burning) 0 (absent) to 3 (severe), ordinal. Clinical success was defined as clinical cure or clinical improvement. Clinical cure was defined as a complete resolution of signs and symptoms (extent of oral lesions score = 0, symptoms score = 0). Clinical improvement was defined as having no visible lesion (extent of lesions score = 0) and minimal symptoms (soreness/burning score <2). Clinical failure was defined as any patient who failed to be clinically cured by the treatment.|7 days|"ITT (all randomized patients who took at least 1 dose of study medication)
PP (all patients in ITT without major protocol deviation, with positive fungal culture, completed at least 10 days of treatment, had main efficacy criteria at test of cure, compliant within 71.4% to 120%, and no forbidden medications taken)"||participants|||Number
729440|NCT00390780|Secondary|Clinical Success at Test-of-cure Visit (Day 17-22) (Using Murray Scoring Scale)|Murray scoring scale range: extent of oral lesions (signs) 0 (none) to 3 (extensive or confluent), ordinal; symptoms (soreness/burning) 0 (absent) to 3 (severe), ordinal. Clinical success was defined as clinical cure or clinical improvement. Clinical cure was defined as a complete resolution of signs and symptoms (extent of oral lesions score = 0, symptoms score = 0). Clinical improvement was defined as having no visible lesion (extent of lesions score = 0) and minimal symptoms (soreness/burning score <2). Clinical failure was defined as any patient who failed to be clinically cured by the treatment.|17 to 22 days|"ITT (all randomized patients who took at least 1 dose of study medication)
PP (all patients in ITT without major protocol deviation, with positive fungal culture, completed at least 10 days of treatment, had main efficacy criteria at test of cure, compliant within 71.4% to 120%, and no forbidden medications taken)"||participants|||Number
729441|NCT00390780|Secondary|Clinical Cure at Day 7 (Using Murray Scoring Scale)|Murray scoring scale range: extent of oral lesions (signs) 0 (none) to 3 (extensive or confluent), ordinal; symptoms (soreness/burning) 0 (absent) to 3 (severe), ordinal. Clinical cure was defined as a complete resolution of signs and symptoms (extent of oral lesions score = 0, symptoms score = 0). Clinical failure was defined as any patient who failed to be clinically cured by the treatment.|7 days|"ITT (all randomized patients who took at least 1 dose of study medication)
PP (all patients in ITT without major protocol deviation, with positive fungal culture, completed at least 10 days of treatment, had main efficacy criteria at test of cure, compliant within 71.4% to 120%, and no forbidden medications taken)"||participants|||Number
729442|NCT00390780|Primary|Clinical Cure (Defined as a Complete Resolution of Signs and Symptoms) After 14 Days of Treatment at the Test of Cure Visit (Day 17-Day 22) Using Murray Scoring Scale|Murray scoring scale range: extent of oral lesions (signs) 0 (none) to 3 (extensive or confluent), ordinal; symptoms (soreness/burning) 0 (absent) to 3 (severe), ordinal. Clinical cure was defined as a complete resolution of signs and symptoms (extent of oral lesions score = 0, symptoms score = 0). Clinical failure was defined as any patient who failed to be clinically cured by the treatment.|17 to 22 days|"Intent-to-Treat (ITT, all randomized patients who took at least 1 dose of study medication)
Per Protocol (PP, all patients in ITT without major protocol deviation, with positive fungal culture, completed at least 10 days of treatment, had main efficacy criteria at test of cure, compliant within 71.4% to 120%, and no forbidden medications taken)"||participants|||Number
729443|NCT00390806|Secondary|Number of Participants Who Died or Progressed|Disease-related events were measured as the number of participants who died or progressed. Progressive disease (PD) is defined as an increase >=25% in any measurable lesion or, in participants with non-measurable disease only, an estimation of an increase >=25%. In both cases, determination of progression included the appearance of any new lesions, or signification worsening of conditions presumed to be related to malignancy. Participants with clinical or laboratory evidence of possible disease progression were to be evaluated radiologically. Data were analyzed with censoring for extended loss to follow-up to account for two or more missed assessments before an event. The date of the last adequate CNS assessment before extended loss to follow-up was used for censored participants.|From Randomization until the last clinic visit associated with the study, up until 35 days after the start of the last course of treatment (up to 75 weeks)|mITT Population||participants|||Number
729444|NCT00390806|Secondary|Brain Symptoms|"Brain symptoms were assessed as the number of participants with neurological signs and symptoms. For brain symptom data, see the outcome measures entitled Number of participants with the indicated investigator assessment for the neurological sign and symptom of X at Baseline, Month 1, and Month 3."|Baseline, Month 1, and Month 3||||||
729445|NCT00390806|Secondary|Lesion Assessment and Measurement|"Lesions were assessed per WHO criteria. For lesion assessment data, see the outcome measure entitled Number of participants with a complete response (CR) or a partial response (PR) (central nervous system [CNS]-radiologic)."|From the time of Randomization until the time of CR or PR (up to 75 weeks)||||||
729817|NCT00383331|Secondary|Time to Treatment Failure|Time to treatment failure was not analyzed because the trial was stopped early due to low enrollment.|baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up|||months||95% Confidence Interval|Median
729446|NCT00390806|Secondary|Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range|"The worst-case change from Baseline in chemistry parameters was measured as decrease to low (DTL), change to normal or no change (CTN/NC), or increase to high (ITH). The worst-case change value could have been measured at any point during the on-therapy period. Participants are counted twice if the participant Decreased to Low and Increased to High during the on-therapy period."|From Randomization until the last clinic visit associated with the study, up until 35 days after the start of the last course of treatment (up to 75 weeks)|"Modified ITT Population. Only those participants with available laboratory values (indicated by the n in the category titles) were analyzed. Different participants may have been analyzed for different parameters; therefore, the overall number of participants analyzed reflects everyone in the Modified ITT Population."||participants|||Number
729447|NCT00390806|Secondary|Number of Participants With Any Adverse Event (AE; Both Serious and Non-serious) or Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect. For a list of all SAEs and AEs, see the SAE/AE module of this results summary.|From Randomization until the last clinic visit associated with the study, up until 35 days after the start of the last course of treatment (up to 75 weeks)|Modified ITT Population: all randomized participants who received at least one dose of randomized therapy. Participants were analyzed by the actual treatment received, even if this differed from the treatment to which they were randomized.||participants|||Number
729448|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment of Ataxia (Balance) at Baseline, Month 1, and Month 3|The investigator assessed participants' status of ataxia (balance) and assigned each participant to one of the following categories: normal; Grade 1, asymptomatic but abnormal on physical examination, and not interfering with function; Grade 2, mild symptoms interfering with function, but not interfering with ADLs; Grade 3, moderate symptoms interfering with ADLs; Grade 4, bedridden or disabling.|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular status at a particular time point, then no participants had that status at that time point.||participants|||Number
729449|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment of Ataxia (Gait) at Baseline, Month 1, and Month 3|The investigator assessed participants' status of ataxia (gait) and assigned each participant to one of the following categories: normal; Grade 1, asymptomatic but abnormal on physical examination, and not interfering with function; Grade 2, mild symptoms interfering with function, but not interfering with ADLs; Grade 3, moderate symptoms interfering with ADLs; Grade 4, bedridden or disabling.|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular status at a particular time point, then no participants had that status at that time point.||participants|||Number
729450|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment of Ataxia (Left Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3|The investigator assessed participants' status of ataxia (left upper extremity: finger to nose testing) and assigned each participant to one of the following categories: normal; Grade 1, asymptomatic but abnormal on physical examination, and not interfering with function; Grade 2, mild symptoms interfering with function, but not interfering with ADLs; Grade 3, moderate symptoms interfering with ADLs; Grade 4, bedridden or disabling.|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular status at a particular time point, then no participants had that status at that time point.||participants|||Number
729451|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment of Ataxia (Right Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3|The investigator assessed participants' status of ataxia (right upper extremity: finger to nose testing) and assigned each participant to one of the following categories: normal; Grade 1, asymptomatic but abnormal on physical examination, and not interfering with function; Grade 2, mild symptoms interfering with function, but not interfering with ADLs; Grade 3, moderate symptoms interfering with ADLs; Grade 4, bedridden or disabling.|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular status at a particular time point, then no participants had that status at that time point.||participants|||Number
729452|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment of Sensation at Baseline, Month 1, and Month 3|The investigator assessed participants' status of sensation and assigned each participant to one of the following categories: normal; loss of deep tendon reflexes or paresthesia, but not interfering with function (not interfering with function); objective sensory loss or paresthesia interfering with function, but not interfering with ADLs (interfering with function); sensory loss or paresthesia interfering with ADLs (intefering with ADLs); permanent sensory loss that interferes with function (permanent sensory loss).|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular status at a particular time point, then no participants had that status at that time point.||participants|||Number
729453|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment of Strength (Left Lower Extremity) at Baseline, Month 1, and Month 3|The investigator assessed participants' status of strength (left lower extremity) and assigned each participant to one of the following categories: normal; Grade 1, asymptomatic with weakness on physical examination; Grade 2, symptomatic and interfering with function, but not interfering with ADLs; Grade 3, symptomatic and interfering with ADLs; Grade 4: bedridden or disabling.|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular status at a particular time point, then no participants had that status at that time point.||participants|||Number
729596|NCT00381303|Secondary|Number of Etravirine-TMC125 (ETR) Subgroup- VL < 50 HIV-1 RNA Copies/mL (TLOVR) Subjects|The Etravirine-TMC125 (ETR Subgroup population was defined as all ITT subjects who took at least 1 dose of ETR)|Week 48|ETR Subgroup- Intention to Treat population (ITT)||participants|||Number
729454|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment of Strength (Right Lower Extremity) at Baseline, Month 1, and Month 3|The investigator assessed participants' status of strength (right lower extremity) and assigned each participant to one of the following categories: normal; Grade 1, asymptomatic with weakness on physical examination; Grade 2, symptomatic and interfering with function, but not interfering with ADLs; Grade 3, symptomatic and interfering with ADLs; Grade 4: bedridden or disabling.|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular status at a particular time point, then no participants had that status at that time point.||participants|||Number
729455|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment of Strength (Left Upper Extremity) at Baseline, Month 1, and Month 3|The investigator assessed participants' status of strength (left upper extremity) and assigned each participant to one of the following categories: normal; Grade 1, asymptomatic with weakness on physical examination; Grade 2, symptomatic and interfering with function, but not interfering with ADLs; Grade 3, symptomatic and interfering with ADLs; Grade 4: bedridden or disabling.|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular status at a particular time point, then no participants had that status at that time point.||participants|||Number
729456|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment of Strength (Right Upper Extremity) at Baseline, Month 1, and Month 3|The investigator assessed participants' status of strength (right upper extremity) and assigned each participant to one of the following categories: normal; Grade 1, asymptomatic with weakness on physical examination; Grade 2, symptomatic and interfering with function, but not interfering with ADLs; Grade 3, symptomatic and interfering with ADLs; Grade 4: bedridden or disabling.|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular status at a particular time point, then no participants had that status at that time point.||participants|||Number
729457|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment of Language (Dysphasia or Aphasia) at Baseline, Month 1, and Month 3|The investigator assessed participants' status of language (dysphasia or aphasia) and assigned each participant to one of the following categories: absent; awareness of receptive or expressive aphasia, not impairing ability to communicate (not impaired); receptive or expressive dysphasia, impairing ability to communicate (impaired); inability to communicate (unable).|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular status at a particular time point, then no participants had that status at that time point.||participants|||Number
729458|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment of Cranial Nerves II-XII at Baseline, Month 1, and Month 3|The investigator assessed participants' status of cranial nerves II-XII and assigned each participant to one of the following categories: normal; present, not interfering with ADLs; present, interfering with ADLs; life threatening, disabling.|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular status at a particular time point, then no participants had that status at that time point.||participants|||Number
729459|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Other Neurological Symptoms at Baseline, Month 1, and Month 3|The investigator (per CTCAE, version 3.0) assessed participants for other neurological symptoms and assigned each participant to one of the following categories: absent, G 1, G 2, G 3, G 4, and G 5. Grade refers to the severity of the AE. The CTCAE displays G 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: G 1: mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; G 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental ADL; G 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self care ADL; G 4: life-threatening consequences, urgent intervention indicated; G 5: death related to AE.|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular grade at a particular time point, then no participants had an event of that grade at that time point.||participants|||Number
729460|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Seizure at Baseline, Month 1, and Month 3|The investigator (per CTCAE, version 3.0) assessed participants for seizure and assigned each participant to one of the following categories: absent, G 1, G 2, G 3, G 4, and G 5. Grade refers to the severity of the AE. The CTCAE displays G 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: G 1: mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; G 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental ADL; G 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self care ADL; G 4: life-threatening consequences, urgent intervention indicated; G 5: death related to AE.|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular grade at a particular time point, then no participants had an event of that grade at that time point.||participants|||Number
729467|NCT00390806|Secondary|Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3|Neurological signs and symptoms data were derived from a participant-reported diary. The participants were asked to assess the following signs and symptoms on a scale of none, mild, moderate, or severe at Months 1 and 3: headache, problems with balance/coordination (PB/C), leg weakness, arm weakness, loss of feeling/numbness (LofF/N), speech difficulty (SD), confusion, loss of memory (LofM), drowsiness, nausea, vomiting, dizziness, visual problems (VP), seizures, leg/ankle swelling (L/AS), heart burn, difficulty sleeping (DS), tiredness, and appetite/weight gain (A/WG).|Months 1 and 3|ITT Population. Only those participants who were assessed for the indicated sign and symptom at the indicated time point were analyzed.||participants|||Number
729597|NCT00381303|Secondary|Number of VL < 50 HIV-1 RNA Copies/mL (TLOVR) Subjects by Race|Intention to Treat population (ITT)|Week 48|ITT||participants|||Number
729461|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Visual Problem at Baseline, Month 1, and Month 3|The investigator (per CTCAE, version 3.0) assessed participants for visual problem and assigned each participant to one of the following categories: absent, G 1, G 2, G 3, G 4, and G 5. Grade refers to the severity of the AE. The CTCAE displays G 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: G 1: mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; G 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental ADL; G 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self care ADL; G 4: life-threatening consequences, urgent intervention indicated; G 5: death related to AE.|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular grade at a particular time point, then no participants had an event of that grade at that time point.||participants|||Number
729462|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Nausea/Vomiting at Baseline, Month 1, and Month 3|The investigator (per CTCAE, version 3.0) assessed participants for nausea/vomiting and assigned each participant to one of the following categories: absent, G 1, G 2, G 3, G 4, and G 5. Grade refers to the severity of the AE. The CTCAE displays G 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: G 1: mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; G 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental ADL; G 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self care ADL; G 4: life-threatening consequences, urgent intervention indicated; G 5: death related to AE.|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular grade at a particular time point, then no participants had an event of that grade at that time point.||participants|||Number
729463|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Vertigo at Baseline, Month 1, and Month 3|The investigator (per CTCAE, version 3.0) assessed participants for vertigo and assigned each participant to one of the following categories: absent, G 1, G 2, G 3, G 4, and G 5. Grade refers to the severity of the AE. The CTCAE displays G 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: G 1: mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; G 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental ADL; G 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self care ADL; G 4: life-threatening consequences, urgent intervention indicated; G 5: death related to AE.|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular grade at a particular time point, then no participants had an event of that grade at that time point.||participants|||Number
729464|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Dizziness/Lightheadedness at Baseline, Month 1, and Month 3|The investigator (per CTCAE, version 3.0) assessed participants for dizziness/lightheadedness and assigned each participant to one of the following categories: absent, G 1, G 2, G 3, G 4, and G 5. Grade refers to the severity of the AE. The CTCAE displays G 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: G 1: mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; G 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental ADL; G 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self care ADL; G 4: life-threatening consequences, urgent intervention indicated; G 5: death related to AE.|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular grade at a particular time point, then no participants had an event of that grade at that time point.||participants|||Number
729465|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Headache at Baseline, Month 1, and Month 3|The investigator (per Common Terminology Criteria for Adverse Events [CTCAE], version 3.0) assessed participants for headache and assigned each participant to one of the following categories: absent, Grade (G) 1, G 2, G 3, G 4, and G 5. Grade refers to the severity of the AE. The CTCAE displays G 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: G 1: mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; G 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental ADL; G 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self care ADL; G 4: life-threatening consequences, urgent intervention indicated; G 5: death related to AE.|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular grade at a particular time point, then no participants had an event of that grade at that time point.||participants|||Number
729466|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Level of Consciousness at Baseline, Month 1, and Month 3|The investigator assessed participants for the neurological sign and symptom of level of consciousness and assigned each participant to one of the following categories: normal; somnolence or sedation not interfering with function (not intefering); somnolence or sedation interfering with function, but not activities of daily living (ADLs) (interfering); obtundation or stupor, difficult to arouse, inteferring with ADLs (obtundation or stupor); coma.|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular status at a particular time point, then no participants had that status at that time point.||participants|||Number
729537|NCT00380861|Secondary|KOOS Score||Pre-operative, 2 and 6 weeks and 6 and 12 months follow up||||||
729538|NCT00380861|Secondary|AKS Score||Pre-operative, 2 and 6 weeks and 6 and 12 months follow up||||||
729468|NCT00390806|Secondary|Time to Progression (TTP) (All Sites of Disease-radiologic)|TTP is defined as the time from Randomization until the first documented sign of disease progression in all sites of disease. Progressive disease (PD) is defined as an increase >=25% in any measurable lesion or, in participants with non-measurable disease only, an estimation of an increase >=25%. In both cases, determination of progression included the appearance of any new lesions, or signification worsening of conditions presumed to be related to malignancy. Participants with clinical or laboratory evidence of possible disease progression were to be evaluated radiologically. TTP was analyzed with censoring for extended loss to follow-up to account for two or more missed assessments before a TTP event. The date of the last adequate CNS assessment before extended loss to follow-up was used for censored participants.|From the time of Randomization until the first documented sign of disease progression (up to 75 weeks)|ITT Population||weeks||95% Confidence Interval|Median
729469|NCT00390806|Secondary|Time to Progression (TTP) (CNS-radiologic)|TTP is defined as the time from Randomization until the first documented sign of disease progression in the CNS. Progressive disease (PD) is defined as an increase >=25% in any measurable lesion or, in participants with non-measurable disease only, an estimation of an increase >=25%. In both cases, determination of progression included the appearance of any new lesions, or signification worsening of conditions presumed to be related to malignancy. Participants with clinical or laboratory evidence of possible disease progression were to be evaluated radiologically. TTP was analyzed with censoring for extended loss to follow-up to account for two or more missed assessments before a TTP event. The date of the last adequate CNS assessment before extended loss to follow-up was used for censored participants.|From the time of Randomization until the first documented sign of disease progression (up to 75 weeks)|ITT Population||weeks||95% Confidence Interval|Median
729470|NCT00390806|Secondary|Time to Response (TTR) (CNS-radiologic)|TTR is defined as the time from Randomization until the first documented evidence of CR or PR in the CNS. CR is defined as the complete disappearance of all known measurable (Must be accurately measured in >=1 dimension) and nonmeasurable disease, without clinical, laboratory, or radiological evidence of recurrence for at least 4 weeks. CR may have been defined in participants with measurable and/or non-measurable disease at Screening. PR is defined as at least a 50% decrease in the sum of the products of the greatest length and perpendicular width of all measurable disease with no clear increase in nonmeasurable disease in participants without measurable disease. In both cases, there must have been no appearance of new disease, and no clinical, laboratory, or radiological evidence of disease progression for at least 4 weeks. Assessment of response was performed by the investigator and was based on unconfirmed responses.|From the time of Randomization until the first documented evidence of CR or PR (up to 75 weeks)|ITT Population. Only those participants with a CR, PR, or a missing response were assessed. TTR was analyzed with censoring for extended loss to follow-up to account for two or more missed response assessments before a TTR event. The date of the last adequate CNS assessment before extended loss to follow-up was used for censored participants.||weeks||95% Confidence Interval|Median
729471|NCT00390806|Secondary|Number of Participants With a Complete Response (CR) or a Partial Response (PR) (Central Nervous System [CNS]-Radiologic)|The number of participants achieving either a CR or PR, per World Health Organization (WHO) Criteria, in the CNS was assessed. CR is defined as the complete disappearance of all known measurable (Must be accurately measured in >=1 dimension) and nonmeasurable disease, without clinical, laboratory, or radiological evidence of recurrence for at least 4 weeks. CR may have been defined in participants with measurable and/or non-measurable disease at Screening. PR is defined as at least a 50% decrease in the sum of the products of the greatest length and perpendicular width of all measurable disease with no clear increase in nonmeasurable disease in participants without measurable disease. In both cases, there must have been no appearance of new disease, and no clinical, laboratory, or radiological evidence of disease progression for at least 4 weeks. Assessment of response was performed by the investigator and was based on unconfirmed responses.|From the time of Randomization until the time of CR or PR (up to 75 weeks)|ITT Population||participants|||Number
729472|NCT00390806|Secondary|Six-month Survival|Six-month survival is defined as the percentage of participants alive at 6 months following randomization. The date of last contact was used for those participants who had not died or were lost to follow-up. These participants were classified as having been censored.|Month 6|ITT Population||percentage of participants|||Number
729473|NCT00390806|Primary|Overall Survival|Overall survival is defined as the time from randomization until the date of death due to any cause. The date of last contact was used for those participants who had not died or were lost to follow-up. These participants were classified as having been censored.|From the time of Randomization until the date of death due to any cause (up to 195 weeks)|Intent-to-Treat (ITT) Population: all randomized participants. Participants were analyzed by the treatment to which they were randomized, even if this differed from the treatment they actually received.||months||95% Confidence Interval|Median
729474|NCT00390858|Secondary|Relative Change in Serum Ferritin Level|Serum levels were drawn at the baseline of the Core Study up to 18 months of the Extension Study. Levels were analyzed for serum ferritin measured in micrograms per Liter. Relative change (%) in serum ferritin level was assessed from Baseline to Extension 18 months. Relative Change = 1 - (Change in ferritin level from Baseline/Baseline level) x 100.|Baseline of Core Study to Extension 18 months, up to 2.5 years.|The safety set was used for all analyses. This comprised of all 40 patients who received at least one dose of deferasirox during the core or extension study.||percent change||Standard Deviation|Mean
729475|NCT00390858|Secondary|Total Body Iron Elimination (TBIE) Rate (mg/kg/Day)|Total Iron Body Elimination (TBIE) Rate [mg/kg/Day] was calculated for each patient based on SQUID ( Superconducting Quantum Interference Device) results.|Baseline of Core Study to End of Extension Study, up to 5 years|The safety set was used for all analyses. This comprised of all 40 patients who received at least one dose of deferasirox during the core or extension study.||mg/kg/Day||Standard Deviation|Mean
729476|NCT00390858|Primary|Change in Liver Iron Concentration (LIC)|Change in Liver Iron Concentration [LIC] measured by means of SQUID (Superconducting Quantum Interference Device). LIC is expressed in milligrams of iron per gram of liver dry weight (mg Fe/g dw)|Baseline of Core Study to End of Extension Study, up to 5 years.|The safety set was used for all analyses. This comprised of all 40 patients who received at least one dose of deferasirox during the core or extension study.||mg Fe/g dw||Standard Deviation|Mean
729539|NCT00380861|Secondary|Effect of Subject Demographics and Anthropometrics on ROM||Pre-operative, 2 and 6 weeks and 6 and 12 months follow up||||||
729477|NCT00390858|Primary|Participants With Adverse Events by Primary System Organ Class (SOC)|Safety parameters were measured by the number and type of adverse events (AEs). An adverse event is any untoward medical occurence in a patient administered a medicinal product that does not necessarily have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign ( for example, an abnormal laboratory finding), symptom or disease temporally associated with the use of the medicinal product, whether or not this is associated with the use of this medicinal product.|4 year extension + core 1 year|The safety set comprising of all the 40 patients who received at least one dose of deferasirox during the core or extension study was used in all analyses.||participants|||Number
729478|NCT00390884|Other Pre-specified|Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone®|Solicited injection site: tenderness, erythema, and swelling; Solicited systemic reactions: fever, vomiting, abnormal crying, drowsiness, appetite loss, and irritability, after each vaccination|Days 0-7 Post-vaccination|The safety analysis was on all enrolled and vaccinated participants, intent-to-treat population.||Percentage of Participants|||Number
729479|NCT00390884|Secondary|Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Post-vaccination With Fluzone®|Antibodies against Influenza virus in Fluzone® Vaccine determined by the Hemagglutination inhibition (HAI) assay method.|Day 28 Post-vaccination|The Geometric Mean Titers were analyzed in the per-protocol immunogenicity population||Titers||95% Confidence Interval|Geometric Mean
729480|NCT00390884|Primary|Percentage of Seroprotected Participants Post-vaccination With Fluzone®|Seroprotection was defined as a Post-vaccination Hemagglutination Inhibition titer of greater than or equal to 1:40.|Day 28 Post-vaccination|Hemagglutination inhibition titers to the Fluzone® vaccine antigens were assessed in the per-protocol immunogenicity population.||Percentage of Participants|||Number
729481|NCT00391027|Secondary|Change From Baseline in Urinary Free 8-iso Prostaglandin F2-alpha (α) in a Subset of Subjects|Urinary free 8-iso prostaglandin F2-alpha (α): compare glucose fluctuations and activation of oxidative stress as assessed by urinary isoprostanes in a subset of subjects randomized to either Exubera® or subcutaneous insulin glargine. The substudy was offered to all subjects. Data not summarized due to cancellation of Exubera® program.|Baseline, Week 26||||||
729482|NCT00391027|Secondary|Change From Baseline in CV Biomarkers - Soluble Tissue Factor (STF)|Change from baseline in soluble tissue factor (pg/ml) calculated as STF at observation minus STF at baseline.|Baseline, Week 26|FAS; LOCF.||pg/ml||Standard Deviation|Mean
729483|NCT00391027|Secondary|Change From Baseline in CV Biomarkers - Thrombin-antithrombin Complexes (Tat-complexes)|Change from baseline in tat-complexes (nanograms per milliliter [ng/ml]) calculated as tat-complexes at observation minus tat-complexes at baseline.|Baseline, Week 26|FAS; LOCF.||ng/ml||Standard Deviation|Mean
729484|NCT00391027|Secondary|Change From Baseline in CV Biomarkers - Interleukin 6 (IL-6)|Change from baseline in IL-6 (picograms per milliliter [pg/ml]) calculated as IL-6 at observation minus IL-6 at baseline.|Baseline, Week 26|FAS; LOCF.||pg/ml||Standard Deviation|Mean
729485|NCT00391027|Secondary|Change From Baseline in Cardiovascular (CV) Biomarkers - High Sensitive C-reactive Protein (Hs-CRP)|Change from baseline in CV biomarker hs-CRP (milligrams per deciliter [mg/dl]) calculated as hs-CRP at observation minus hs-CRP at baseline.|Baseline, Week 26|FAS; LOCF.||mg/dl||Standard Deviation|Mean
729486|NCT00391027|Secondary|Continuous Glucose Monitoring System (CGMS) 24-hour Glucose Profile in a Subset of Patients|The mean of the 24-hour mean and the mean of the 24-hour standard deviation (SD) (variability around the average glucose concentration) calculated on glucose values (mg/dl) collected during inpatient evaluation of glycemic stability. Interstitial glucose assessed at 5 minute intervals starting pre-supper on Day 1 of evaluation; ending on Day 3 pre-breakfast. Analysis is on data generated between 6:00 am on Day 2 and 6:00 am on Day 3.|Baseline, Week 26|FAS; (n) = number of subjects with analyzable data at observation for inhaled insulin and insulin glargine, respectively. Revised table rectifies a programming code error that was determined post-Clinical study report (CSR) approval.||mg/dl||Standard Deviation|Mean
729487|NCT00391027|Secondary|Change From Baseline in Treatment Satisfaction, Quality of Life, and Mental Health|Subject reported outcomes for Diabetes Treatment Satisfaction Questionnaire-Status (DTSQs), DTSQ-change, Patient Satisfaction with Insulin Therapy-16 item, Mental Health Inventory-17 item, and Euro Quality of life 5-Dimensions (EuroQol 5-D) Questionnaire not summarized due to cancellation of Exubera® program.|Week 26||||||
729488|NCT00391027|Secondary|Number of Subjects Discontinued Due to Insufficient Clinical Response|Number of subjects discontinued due to signs and symptoms of persistent hyperglycemia or HbA1c > 12.0 % or frequent and unexplained severe hypoglycemic events (> 3 events per month for 2 or more months); subject's HbA1c not < = 7 % at Week 12.|Week 26|Safety population: all subjects who received at least 1 dose of study medication.||participants|||Number
729489|NCT00391027|Secondary|Change From Baseline in Body Mass Index (BMI)|BMI measured as kilograms per meter squared (kg/m2). Change calculated as BMI at observation minus BMI at baseline.|Baseline, Week 26|FAS; LOCF.||kg/m2||Standard Deviation|Mean
729490|NCT00391027|Secondary|Change From Baseline in Body Weight|Change from baseline calculated as body weight at observation minus body weight at baseline.|Baseline, Week 26|FAS; LOCF.||kilograms (kg)||Standard Deviation|Mean
729491|NCT00391027|Secondary|Number of Events of Nocturnal Hypoglycemia|Number of events of nocturnal hypoglycemia, incidence: midnight to 6:00 am. Hypoglycemia: characteristic symptoms of hypoglycemia with no blood glucose check; resolved with food intake, SC glucagon, or intravenous (IV) glucose; or symptoms with glucose <3.27 mmol/L (59 mg/dL); or any glucose measurement <=2.72 mmol/L (49 mg/dl). Severity of nocturnal glycemia not summarized.|Week 26|FAS||events|||Number
729492|NCT00391027|Secondary|Number of Subjects With Hypoglycemic Events by Severity|Number of subjects with hypoglycemic events by severity. Severe hypoglycemia: subject unable to treat self; exhibits a neurological symptom; and blood glucose <=2.72 mmol/L or blood glucose not measured but symptoms reversed with food intake, SC glucagon, or intravenous glucose. If all 3 criteria not met, hypoglycemia defined as mild or moderate.|Week 26|FAS||participants|||Number
729540|NCT00380861|Secondary|Single Leg Passive Flexion at All Scheduled Follow-up Visits: 2 Weeks, 6 Weeks, 6 Months and 12 Months.||Pre-operative, 2 and 6 weeks and 6 and 12 months follow up||||||
729818|NCT00383331|Secondary|Duration of Response|Duration of response was not analyzed because the trial was stopped early due to low enrollment.|baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up|||months||95% Confidence Interval|Median
729493|NCT00391027|Secondary|Analysis of Home Blood Glucose Monitoring (HBGM) (7 & 8 Point)|Blood glucose (BG) self-monitored by subject at home; measured at least once between Visits 2, 3 and between Visits 8, 9 (8-point: fasting, pre-meal, post-meal, bedtime, 2:00 am); between each visit: Visit 3 to 8 (7-point: fasting, post-meal, pre-lunch, pre-dinner, bedtime). Post-meal: 2-hour period after breakfast, lunch, dinner. Change: average overall absolute, pre-meal, and post-meal blood glucose = HBGM at observation minus HBGM at baseline; pre-meal to post-meal blood glucose = HBGM at post-meal minus HBGM at pre-meal.|Baseline, Week 26|FAS; LOCF; (n) = number of subjects with analyzable data at observation for inhaled insulin and insulin glargine, respectively.||mg/dl||Standard Deviation|Mean
729494|NCT00391027|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) Level|FPG measured as milligrams/deciliter (mg/dl). Change from baseline calculated as FPG at observation minus FPG at baseline.|Baseline, Week 26|FAS; LOCF.||mg/dl||Standard Deviation|Mean
729495|NCT00391027|Secondary|Number of Subjects With HbA1c < 8.0 %|Number of subjects with glycemic control HbA1c measurement of < 8.0 % at observation.|Week 26|FAS||participants|||Number
729496|NCT00391027|Secondary|Number of Subjects With HbA1c < 7.0 %|Number of subjects with glycemic control HbA1c measurement of < 7.0 % at observation.|Week 26|FAS||participants|||Number
729497|NCT00391027|Secondary|Number of Subjects With HbA1c < 6.5 %|Number of subjects with glycemic control HbA1c measurement of < 6.5 % at observation.|Week 26|FAS||participants|||Number
729498|NCT00391027|Secondary|Change From Baseline in HbA1c Prior to Week 26|Change (measured as percent) from baseline calculated as HbA1c at observation minus HbA1c at baseline.|Baseline, Week 2, Week 4, Week 8, Week 12, and Week 18|FAS; LOCF; (n) = number of subjects with analyzable data at observation for inhaled insulin and insulin glargine, respectively.||percent||Standard Deviation|Mean
729499|NCT00391027|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26|Change (measured as percent): HbA1c at observation minus HbA1c at baseline. Primary objective to demonstrate non-inferiority of inhaled insulin compared to insulin glargine for glycemic control after 26 weeks of treatment not attainable due to early termination of study; analyses were descriptive and graphical.|Baseline, Week 26|Full analysis set (FAS) all randomized subjects with at least 1 dose of study medication, baseline and post-baseline HbA1c measurement. Last observation carried forward (LOCF).||percent||Standard Deviation|Mean
729500|NCT00391053|Secondary|Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone® High-Dose or Standard Fluzone® Vaccination|The occurrence, time to onset, number of days of occurrence, and severity of solicited injection site reactions: Injection Site Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia were collected.|Day 0 to Day 7 Post-vaccination|The safety analysis was performed on the Full Analysis Set according to the participants who actually received a vaccine, whether or not the subject received the assigned vaccine. A total of 3,833 participants were included in the analysis set for the evaluation of all safety.||Percentage of Participants|||Number
729501|NCT00391053|Secondary|Percentage of Participants With Seroprotection Pre- and Post-Vaccination With Fluzone® High-Dose or Standard Fluzone® Vaccines.|Seroprotection was defined as a Hemagglutination Inhibition Titers of at least 40 (≥ 1:40) for each of the Influenza vaccine antigens (A/H1N1 New-Caledonia; A/H3N2 Wisconsin; and B Malaysia) pre- or post-vaccination with Fluzone® High-Dose or Standard Fluzone® vaccines.|Day 0 and Day 28 Post-vaccination|The immunogenicity analysis was performed on the Full Analysis Set according to the vaccine the subjects were randomized to receive. A total of 3851 participants were included in this analysis.||Percentage of Participants|||Number
729502|NCT00391053|Primary|Percentage of Participants With Seroconversion Post-vaccination With Fluzone® High-Dose or Standard Fluzone® Vaccines.|Seroconversion was defined as a Hemagglutination Inhibition Antibody Titers of Titer ≥40 (1/dil) on Day 28 if pre-vaccination (Day 0) titer <10 (1/dil); or a four-fold increase of titer on Day 28, if pre-vaccination (Day 0) titer is ≥10 (1/dil) for each of the three Influenza vaccine antigens (A/H1N1 New-Caledonia; A/H3N2 Wisconsin; and B Malaysia).|Day 28 Post-vaccination|The immunogenicity analysis was performed on the Full Analysis Set according to the vaccine the subjects were randomized to receive. A total of 3851 participants were included in this analysis.||Percentage of Participants|||Number
729503|NCT00391053|Primary|Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibody Titers Pre- and Post-vaccination With Fluzone® High Dose or Standard Fluzone® Vaccines.|Antibodies against each of three Influenza antigens (virus) in Fluzone® High-Dose and Standard Fluzone® vaccines (A/H1N1 New-Caledonia; A/H3N2 Wisconsin; and B Malaysia) were determined by the Hemagglutination inhibition assay method.|Day 0 and Day 28 Post-vaccination|The geometric mean titers was assessed in the Full Analysis Set according to the vaccine the subjects were randomized to receive. A total of 3851 participants were included in this analysis.||Titers||95% Confidence Interval|Geometric Mean
729504|NCT00391079|Secondary|Change in Sleep Disruption NRS|"The sleep disruption NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate how your pain disrupted your sleep last night? where 0 = did not disrupt sleep and 10 = completely disrupted (unable to sleep at all). A negative value indicates an improvement in sleep disruption score from baseline."|14 weeks; Baseline to end of treatment (last 7 days)|||points on a scale||Standard Deviation|Mean
729505|NCT00391079|Secondary|Change in Subject Global Impression of Change (SGIC)|A 7-point Likert-type scale was used, with the question: ‘Please assess the status of your pain due to multiple sclerosis since entry into the study using the scale below’ with the markers “very much improved, much improved, slightly improved, no change, slightly worse, much worse or very much worse”. At baseline subjects wrote a brief description of their pain caused by multiple sclerosis which was used at Week 14 to aid their memory regarding their symptoms at study start. For each of above markers the number of participants were reported.|Week 14|All subjects who completed the question were included in the analysis. Two subjects from the Sativex group and six subjects from the placebo group did not complete the question.||percentage of subjects|||Number
729554|NCT00380978|Primary|Delivered by Cesarean Section|The decision to proceed to operative delivery was made by the obstetric team for maternal or fetal indications.|Time form initiation of labor analgesia to delivery (up to 24 hours)|Analysis per protocol. 10 did not receive intervention in combined spinal epidural group and 2 in the systemic analgesia group||participants|||Number
729506|NCT00391079|Secondary|Change From Baseline to End of Treatment in BPI (Brief Pain Inventory) Short Form|The BPI-SF is a 14-item questionnaire that asks patients to rate pain over the prior week and the degree to which it interferes with activities on a 0 to 10 scale, where 0=no pain and 10=pain as bad as you can imagine. Severity is measured as worst pain, least pain, average pain, and pain right now. The severity composite score was calculated as the arithmetic mean of the four severity items(range 0-10). The minimum value is zero and maximum is 10. A higher score represents a poor outcome.|14 weeks: Baseline to end of treatment (last 7 days of treatment)|All subjects who completed the BPI-short form were included in the analysis. Four subjects from the sativex group and three subjects from the placebo group did not complete the form.||Points on a scale||Standard Deviation|Mean
729507|NCT00391079|Secondary|Change From Baseline to End of Treatment in Break-through Analgesia Usage|Use of break through medication was recorded daily during the 14 weeks of the study as the number of paracetamol tablets taken. The change in mean daily quantities of tablets used was calculated from baseline to the last seven days of treatment.|14 weeks: baseline - end of treatment (last 7 days)|||tablets||Standard Deviation|Mean
729508|NCT00391079|Secondary|Change in Pain From Baseline to End of the Treatment Using the NPS (Neuropathic Pain Scale)|The NPS score is 0-100 sum of 10 individual pain scores (0-10 NRS, 0= no pain to 10 = most pain imaginable). A negative change from baseline indicates an improvement in pain.|14 weeks: Baseline - End of treatment (Week 14)|||Points on a scale||Standard Deviation|Mean
729509|NCT00391079|Primary|Number of Patients With at Least 30% Improvement in Numerical Rating Scale (NRS) Pain Score From Baseline|"A positive 30% pain response is defined as a reduction of at least 30% in the mean NRS pain score from baseline to week 14 (last 7 days). The patient was asked on a scale of '0 to 10', please indicate the number that best describes your pain in the last 24 hours where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain due to multiple sclerosis. The pain NRS was completed at the same time each day, i.e. bedtime in the evening."|14 weeks: Baseline - end of treatment (last 7 days)|||participants|||Number
729510|NCT00391079|Primary|Change in Mean Pain Due to MS NRS Score|"The pain NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate the number that best describes your pain in the last 24 hours where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain due to multiple sclerosis. A negative value indicates an improvement in pain score from baseline."|14 weeks: Baseline - End of Treatment (last 7 days of treatment)|Change in mean daily NRS score||units on a scale||Standard Deviation|Mean
729511|NCT00391092|Secondary|Change From Baseline for FACT-G and FACT-B|FACT-G is core questionnaire of Functional Assessment of Chronic Illness Therapy (FACIT) measurement system to evaluate quality of life (QoL) in cancer population. FACT-G consisted of 27 questions grouped in 4 domains of general Health-Related QoL (HRQoL): Physical Well-being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB) and Functional Well-Being (FWB); each ranged from 0 (not at all) to 4 (very much). FACT-G ranged between 0-108. Since questions could be reversed coded, as appropriate, before calculating FACT-G, 0 and 108 could be considered worst and best health states. FACT -B is used for assessment of HRQoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: 7 items for each physical, functional, social/family; all 3 ranged from 0-28, emotional (6 items) ranged from 0-24, and breast cancer subscale (9 items) ranged from 0-36. All single-item measures ranges from 0-144. High scale score represents a better QoL.|Baseline, Cycles 3, 5, 11, and post PD (14 to 28 days after disease progression [up to the clinical cutoff of 30 June 2011, up to 4.75 years])|ITT Population; n (number) = number of participants assessed for the given parameter at the specified visit.||units on a scale||Standard Deviation|Mean
729512|NCT00391092|Secondary|Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores|FACT-G is core questionnaire of Functional Assessment of Chronic Illness Therapy (FACIT) measurement system to evaluate quality of life (QoL) in cancer population. FACT-G consisted of 27 questions grouped in 4 domains of general Health-Related QoL (HRQoL): Physical Well-being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB) and Functional Well-Being (FWB); each ranged from 0 (not at all) to 4 (very much). FACT-G ranged between 0-108. Since questions could be reversed coded, as appropriate, before calculating FACT-G, 0 and 108 could be considered worst and best health states. FACT -B is used for assessment of HRQoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: 7 items for each physical, functional, social/family; all 3 ranged from 0-28, emotional (6 items) ranged from 0-24, and breast cancer subscale (9 items) ranged from 0-36. All single-item measures ranges from 0-144. High scale score represents a better QoL.|Baseline, Cycles 3, 5, 11, and post progressive disease (PD; 14 to 28 days after disease progression [up to the clinical cutoff of 30 June 2011, up to 4.75 years])|ITT Population; n (number) = number of participants assessed for the given parameter at the specified visit.||units on a scale||Standard Deviation|Mean
729513|NCT00391092|Secondary|Time to Treatment Failure (TTF)|TTF was defined as the time between randomization and date of disease progression (per RECIST v1.0; unequivocal progression of existing non-target lesions), death, or withdrawal of treatment due to adverse events, withdrawal of informed consent, insufficient therapeutic response, refusal of treatment/failure to co-operate, or failure to return, whichever occurred first. Progressive disease is defined using RECIST v1.0 as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started.|Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)|ITT Population||months||95% Confidence Interval|Median
729514|NCT00391092|Secondary|Duration of Response (DR)|DR was defined as the time when response (CR or PR per RECIST v1.0) was first documented to the date of disease progression per RECIST v1.0 (unequivocal progression of existing non-target lesions) or death. Progressive disease is defined using RECIST v1.0 as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started.|Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)|ITT Population: only participants with a best OR of CR or PR were included in the analysis.||months||95% Confidence Interval|Median
729819|NCT00383331|Secondary|Time to Progressive Disease|Time to progressive disease not analyzed because trial was stopped early due to low enrollment.|baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up|||months||95% Confidence Interval|Median
729515|NCT00391092|Secondary|Percentage of Participants With a Best Overall Response (OR) of Confirmed Complete Response (CR) or Partial Response (PR) in Participants With Measurable Disease at Baseline|Best OR was assessed using RECIST v1.0 criteria. Participants were classified as responders if their best OR was either confirmed CR (disappearance of all target lesions) or confirmed PR (at least a 30% decrease in the sum of the longest diameter [LD] of target lesions, taking as reference the baseline sum LD). Participants without any post-baseline assessments were regarded as non-responders. The 95% CI for the one sample binomial using Pearson-Clopper method.|Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)|ITT Population; only participants with measurable disease at baseline were included in the analysis.||percentage of participants||95% Confidence Interval|Number
729516|NCT00391092|Secondary|Overall Survival (OS)|OS was defined as the time from randomization to the date of death, regardless of the cause of death. OS was estimated using Kaplan-Meier methods.|Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)|ITT Population||months||95% Confidence Interval|Median
729517|NCT00391092|Primary|Progression Free Survival (PFS)|PFS was defined as the time from randomization to time of first documented disease progression (unequivocal progression of existing non-target lesions) or death, whichever occurred first as assessed by Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0). Progressive disease is defined using RECIST v1.0 as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started. Primary PFS variable was defined based on the investigators’ assessments and the statistical conclusions on the primary efficacy endpoint were based on investigator assessed PFS. PFS was estimated using Kaplan-Meier methods.|Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)|ITT Population||months||95% Confidence Interval|Median
729518|NCT00391222|Secondary|Time to Recurrence of a Mood Episode (Exploratory/Olanzapine)|Recurrence was defined as for the risperidone LAI and placebo arms (meeting any of 5 criteria). Since the study was designed to compare the efficacy of risperidone LAI versus placebo, this olanzapine analysis was exploratory in nature.|Assessed at every visit from the moment of randomization to a treatment arm (baseline Period III) until the end of treatment (Month 21 or earlier)|ITT analysis set for Period III: all randomized patients who received at least one dose of double-blind study medication and who had at least one post-baseline visit. This excluded 1 patient in the olanzapine arm (discontinued the study due to non-compliance to the study medication).||days||Standard Error|Mean
729519|NCT00391222|Secondary|Change From Double-blind Baseline to Endpoint in Montgomery Åsberg Depression Rating Scale (MADRS)|The MADRS was assessed by an adequately trained clinician who did not provide psychotherapy or psycho-education to the patient. The scale consists of 10 items that cover all of the core depressive symptoms. Each item is scored from 0 to 6 and a total score is calculated by adding the scores of all 10 items. For each individual item as well as for the total score, a higher score represents a more severe condition.|Assessed at every visit from the moment of randomization to a treatment arm (baseline Period III) until the end of treatment (Month 21 or earlier)|ITT analysis set for Period III: all randomized patients who received at least one dose of double-blind study medication and who had at least one post-baseline visit. This excluded 2 patients in both the risperidone LAI arm (discontinued the study due to withdrawal of consent or adverse event) and placebo arm (both withdrew consent).||units on a scale||Standard Error|Mean
729520|NCT00391222|Secondary|Change From Double-blind Baseline to Endpoint in Young Mania Rating Scale (YMRS)|The 11-item YMRS was administered by an adequately trained clinician who did not provide psychotherapy or psycho-education to the patient. A severity rating was assigned to each of the items, based on the patient's subjective report of his or her condition over the previous 7 days or since the last visit (whichever was shorter) and the clinician’s behavioral observations during the interview, with emphasis on the latter. The total YMRS score included the score of all 11 items ranging from 0 to 60, a higher score indicating a more severe condition.|Assessed at every visit from the moment of randomization to a treatment arm (baseline Period III) until the end of treatment (Month 21 or earlier)|ITT analysis set for Period III: all randomized patients who received at least one dose of double-blind study medication and who had at least one post-baseline visit. This excluded 2 patients in both the risperidone LAI arm (discontinued the study due to withdrawal of consent or adverse event) and placebo arm (both withdrew consent).||units on a scale||Standard Error|Mean
729521|NCT00391222|Secondary|Time to Early Study Discontinuation for Any Reason|The robustness of the primary outcome analysis was tested by means of a sensitivity analysis: patients who discontinued the study during Period III for any reason were analyzed as having a recurrence of a mood episode at the time of their study discontinuation. The same survival analysis method as for the primary outcome was applied.|Assessed at every visit from the moment of randomization to a treatment arm (baseline Period III) until the end of treatment (Month 21 or earlier)|ITT analysis set for Period III: all randomized patients who received at least one dose of double-blind study medication and who had at least one post-baseline visit. This excluded 2 patients in both the risperidone LAI arm (discontinued the study due to withdrawal of consent or adverse event) and placebo arm (both withdrew consent).||days||Standard Error|Mean
729522|NCT00391222|Secondary|Time to Recurrence of a Depressive Episode|Recurrences were classified as elevated mood or depressive by the investigator based on the patient's data at the time of the event. Time to recurrence of a depressive episode was estimated by means of the same survival analysis method as for the primary outcome.|Assessed at every visit from the moment of randomization to a treatment arm (baseline Period III) until the end of treatment (Month 21 or earlier)|ITT analysis set for Period III: all randomized patients who received at least one dose of double-blind study medication and who had at least one post-baseline visit. This excluded 2 patients in both the risperidone LAI arm (discontinued the study due to withdrawal of consent or adverse event) and placebo arm (both withdrew consent).||days||Standard Error|Mean
729571|NCT00381095|Secondary|Change From Baseline in Average Pain Scores at Weeks 1, 2, 3 and 4|Change from baseline in daily average pain score NRS 0 (no pain) to 10 (pain as bad as you can imagine) for pain intensity over past 24 hours recorded every evening before bedtime. Change was week x average minus baseline average.|Baseline, Weeks 1, 2, 3 and 4 or ET|Data not analyzed due to early study termination.||Units on a scale||Standard Deviation|Mean
729523|NCT00391222|Secondary|Time to Recurrence of an Elevated Mood (Hypomanic, Manic, or Mixed) Episode|Recurrences were classified as elevated mood or depressive by the investigator based on the patient's data at the time of the event. Time to recurrence of an elevated mood episode was estimated by means of the same survival analysis method as for the primary outcome.|Assessed at every visit from the moment of randomization to a treatment arm (baseline Period III) until the end of treatment (Month 21 or earlier)|ITT analysis set for Period III: all randomized patients who received at least one dose of double-blind study medication and who had at least one post-baseline visit. This excluded 2 patients in both the risperidone LAI arm (discontinued the study due to withdrawal of consent or adverse event) and placebo arm (both withdrew consent).||days||Standard Error|Mean
729524|NCT00391222|Primary|Time to Recurrence of a Mood Episode (Risperidone LAI Versus Placebo)|Recurrence was estimated using the Kaplan-Meier method and defined as meeting any of the following: DSM-IV-TR criteria for a hypomanic, manic, mixed, or depressive episode; in need of mood stabilizer, antipsychotic medication, benzodiazepine or antidepressant; requiring hospitalization for mood episode; either Young Mania Rating Scale (YMRS) >12 or Montgomery-Åsberg Depression Rating Scale (MADRS) >12 combined with Clinical Global Impression – Severity (CGI-S) >=4; in need of increase in study medication dose or supplementation with oral risperidone or another antipsychotic or mood stabilizer.|Assessed at every visit from the moment of randomization to a treatment arm (baseline Period III) until the end of treatment (Month 21 or earlier)|ITT analysis set for Period III: all randomized patients who received at least one dose of double-blind study medication and who had at least one post-baseline visit. This excluded 2 patients in both the risperidone LAI arm (discontinued the study due to withdrawal of consent or adverse event) and placebo arm (both withdrew consent).||days||Standard Error|Mean
729525|NCT00391274|Post-Hoc|Number of Patients With Disease Progression|Number of patients who have died or have had progression of disease. This outcome substitutes for the outcome on Duration of Response.|time of response to progressive disease (up to 12 months)|Patients who qualified for response (met following criteria: histologic or cytologic diagnosis of NSCLC that was not amenable to curative therapy; no concurrent systemic chemotherapy; presence of measurable or evaluable disease). Patients censored: pemetrexed=6, docetaxel=3.||participants|||Number
729526|NCT00391274|Primary|Overall Survival|Overall survival was defined as the time from the date of study enrollment to the date of death due to any cause. Survival time was censored at the date of last contact for patients who were still alive or lost to follow-up. An amendment allowed for the collection of overall survival on an additional 43 survival events. At the time the original record was released, it was not possible to provide results with the 95% Confidence Interval (CI) since the upper limit was not calculable. The median and 95% CIs are now reported.|baseline to date of death from any cause (up to 24 months after study enrollment); amendment (up to 30 months after study enrollment)|Intent to treat population. Number of patients censored (up to 24 months): pemetrexed = 51, docetaxel = 55. Number of participants censored (up to 30 months): pemetrexed = 30, docetaxel = 32.||months||95% Confidence Interval|Median
729527|NCT00391274|Secondary|Pharmacology Toxicity|Maximum common terminology criteria (CTC) Grade 3 or 4 toxicities possibly related to study drug are reported. The worst grade event per cycle is reported. Grades range from 0 (none) to 5 (death). Grade 3 events are severe and Grade 4 events are life-threatening.|first dose of study drug up to 24 months|Patients who received at least one dose of study drug.||participants|||Number
729528|NCT00391274|Secondary|Duration of Response|"Duration of tumor response is the duration from date of first objective status assessment of a complete or partial response to the first date of progression or death from any cause. For each patient who is not known to have died or to have had a progression of disease as of the data inclusion cut-off date, duration of tumor response was censored at the time of last prior contact. Due to the low number of patients in the analysis, the median duration of tumor response could not be calculated for the docetaxel arm. Available data are presented as Number of Patients with Disease Progression."|time of response to progressive disease (up to 24 months)|Patients who qualified for response (met following criteria: histologic or cytologic diagnosis of NSCLC that was not amenable to curative therapy; no concurrent systemic chemotherapy; presence of measurable or evaluable disease). Results not presented because median was not calculable for the docetaxel arm.||months||95% Confidence Interval|Median
729529|NCT00391274|Secondary|Progression-Free Survival (PFS)|Progression-free survival (PFS) time was defined as the time from the date of study enrollment to the date of the first of the following events: objective disease progression or death due to any cause. For patients who were alive and had not progressed, PFS was censored at the last contact.|baseline to measured progressive disease (up to 24 months after study enrollment)|"Intent to treat population. Patient censored:
pemetrexed=25, docetaxel=39."||months||95% Confidence Interval|Median
729530|NCT00391274|Secondary|Overall Tumor Response|"Response based on Response Evaluation Criteria In Solid Tumors (RECIST), which define when cancer patients improve (respond), stay the same (stabilize), or worsen (progression) during treatments. CR (complete response) = disappearance of all target lesions; PR (partial response) = 30% decrease in the sum of the longest diameter of target lesions; PD (progressive disease) = 20% increase in the sum of the longest diameter of target lesions; SD (stable disease) = small changes that do not meet above criteria."|baseline to measured tumor response (up to 24 months after study enrollment)|Patients who received at least one dose of study drug and qualified for tumor response analysis (met following criteria: histologic or cytologic diagnosis of NSCLC that was not amenable to curative therapy; no concurrent systemic chemotherapy; presence of measurable or evaluable disease).||participants|||Number
729531|NCT00380861|Secondary|Single Leg Active Flexion at 2 Weeks, 6 Weeks, 6 Months and 12 Months.||2 weeks, 6 weeks, 6 months and 12 months||||||
729532|NCT00380861|Primary|Knee Society Passive Flexion at 6 Months|The patient lies supine (on their back) on the table and a medically trained professional moves the limb to bend the knee to a maximum flexion position. The angle of flexion is measured with a goniometer, which is an angle-measuring device.|6 months|||Degrees of passive flexion||Standard Deviation|Mean
729533|NCT00380861|Secondary|Subject Satisfaction||Pre-operative, 2 and 6 weeks and 6 and 12 months follow up||||||
729534|NCT00380861|Secondary|Crepitus||Pre-operative, 2 and 6 weeks and 6 and 12 months follow up||||||
729535|NCT00380861|Secondary|Ability to Perform Activities||Pre-operative, 2 and 6 weeks and 6 and 12 months follow up||||||
729536|NCT00380861|Secondary|Knee Pain||Pre-operative, 2 and 6 weeks and 6 and 12 months follow up||||||
729541|NCT00380874|Primary|Duration Adjusted Average Change (DAAC) of Paresthesia From the Onset of Chemotherapy Measured by Numeric Rating Scale (NRS)|Least squares mean of change: mean at cycle minus mean at Baseline. Paresthetic duration Adjusted Average Change (DAAC) endpoint was computed based on Numeric Rating Scale (NRS) of paresthesia (collected 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-10=severe pain). DAAC endpoint is defined as the Area Under Curve (AUC) of the collected NRS over time, divided by the collection time period (up to 10 days).|Period of 10 days from the onset of chemotherapy to the last cycle: Last Observation Carried Forward (LOCF)|Intent-to-Treat (ITT) population: subjects with at least 1 dose of study medication and for whom at least 1 post-baseline efficacy evaluation was obtained; Last Observation Carried Forward (LOCF): last recorded cycle. Primary analysis timeframe: 10 days of paresthesia scores from the onset of chemotherapy to the last cycle of chemotherapy (LOCF).||score on scale||Standard Error|Least Squares Mean
729542|NCT00380874|Secondary|Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms|Number of participants with persistent paresthesic, dyesthesic, and pain symptoms at chemotherapy Cycle 9 and last observation carried forward (LOCF) endpoint. Numeric rating scale of symptoms: >=1: mild symptoms to >=4: moderate severe symptoms. Subjects rated their average severity of symptoms over the last 24 hours every evening before bedtime.|Cycle 9 and Last Observation Carried Forward (LOCF) cycle endpoint|ITT population, subjects with at least 1 dose of study medication and for whom at least 1 post-baseline efficacy evaluation was obtained.||participants|||Number
729543|NCT00380874|Secondary|Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle|Least squares (LS) mean of change: mean at cycle minus mean at Baseline. Neuropathic Pain Symptom Inventory (NPSI) = questionnaire designed to evaluate symptoms of neuropathic pain. 11-point numeric rating scale, range: 0 (no pain) to 10 (worst pain imaginable) best describing their average pain for last 24 hours.|Baseline to Cycle 9, Last Observation Carried Forward (LOCF) cycle endpoint|ITT population: subjects with at least 1 dose of study medication and for whom at least 1 post-baseline efficacy evaluation was obtained.||score on scale||Standard Error|Least Squares Mean
729544|NCT00380874|Secondary|Duration Adjusted Average Change (DAAC) of Pain Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS)|Least squares (LS) mean of change: mean at cycle minus mean at Baseline. Pain Duration Adjusted Average Change (DAAC) endpoint was computed based on Numeric Rating Scale (NRS) of pain (collected 0=no pain; 1-3=mild pain; 4–6=moderate pain; 7-10=severe pain). DAAC endpoint was defined as the Area Under Curve (AUC) of the collected NRS over time, divided by collection time period (up to 10 days).|Baseline to Cycle 9, LOCF cycle endpoint|ITT population: subjects with at least 1 dose of study medication and for whom at least 1 post-baseline efficacy evaluation was obtained.||score on scale||Standard Error|Least Squares Mean
729545|NCT00380874|Secondary|Duration Adjusted Average Change (DAAC) of Dysesthesia Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS)|Least squares (LS) mean of change: mean at cycle minus mean at Baseline. Dysesthesic Duration Adjusted Average Change (DAAC) endpoint was computed based on Numeric Rating Scale (NRS) of dysesthesis (collected 0=no pain; 1-3=mild pain; 4–6=moderate pain; 7-10=severe pain). DAAC endpoint was defined as the Area Under Curve (AUC) of the collected NRS over time, divided by collection time period (up to 10 days).|Baseline to Cycle 9, LOCF cycle endpoint|ITT population, subjects with at lest 1 dose of study medication and for whom at least 1 post-baseline efficacy evaluation was obtained.||score on scale||Standard Error|Least Squares Mean
729546|NCT00380874|Secondary|Duration Adjusted Average Change (DAAC) of Paresthesic Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS)|Least squares mean of change: mean at cycle minus mean at Baseline. Paresthetic Duration Adjusted Average Change (DAAC) endpoint was computed based on Numeric Rating Scale (NRS) of paresthesia (collected 0=no pain; 1-3=mild pain; 4–6=moderate pain; 7-10=severe pain). DAAC endpoint is defined as the Area Under Curve (AUC) of the collected NRS over time, divided by collection time period (up to 10 days).|Baseline to Cycle 9|Intent-to-Treat (ITT) population: subjects with at least 1 dose of study medication and for whom at least 1 post-baseline efficacy evaluation was obtained.||score on scale||Standard Error|Least Squares Mean
729547|NCT00380978|Secondary|Vomiting|Vomiting during labor analgesia|Vomiting at second analgesia request|||participants|||Number
729548|NCT00380978|Secondary|Neonatal Outcome (APGAR Score < 7 at 5 Minutes)|Infant's Apgar scores measured at 5 minutes of life and were assigned by nurses and pediatricians responsible for neonatal assessment. The Apgar score is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing the five values. The categories are skin color, pulse, reflex to stimulation, muscle tome, and breathing. The test was done at one and five minutes after birth, and may be repeated later if the score is and remains low. Scores 3 and below are generally regarded as critically low, 4 to 6 fairly low, and 7 to 10 generally normal.|APGAR score at 5 minutes|||participants|||Number
729549|NCT00380978|Secondary|Nausea|Participants were asked to rate their nausea (as none, mild, moderate, or severe) and report the presence or absence of vomiting.|At second analgesia request|||participants|||Number
729550|NCT00380978|Secondary|Analgesia Efficacy|Patients were asked to rate their average pain score using an 11-point verbal rating score (VRS)for pain (0 - 10: 0= no pain, 10= worst pain imaginable) between 1st and 2nd analgesia request.|At first and second analgesia requests|||Scores on a scale||Inter-Quartile Range|Median
729551|NCT00380978|Secondary|Indication for Cesarean Delivery|The decision to proceed to operative delivery was made by the obstetric team for maternal or fetal indications.|At time of decision for delivery|Number of cesarean deliveries||participants|||Number
729552|NCT00380978|Secondary|Duration of Labor|Labor was induced by initiating an oxytocin infusion or by infusing extra-amniotic saline followed by oxytocin. All participants had continuous external electronic fetal heart rate (FHR) monitoring and tocodynamometry. Internal fetal scalp electrodes were placed when the external tracing was not interpretable, and intrauterine pressure catheters were used to measure the intensity of contractions when deemed necessary by the obstetricians. Artificial rupture of membranes was performed, and nurses titrated oxytocin infusions according to institutional protocol.|Initiation of induction of labor to time of delivery|Per protocol||minutes||Inter-Quartile Range|Median
729553|NCT00380978|Secondary|Instrumented Vaginal Delivery|The decision to proceed to assisted/instrumental delivery was made by the obstetric team for maternal or fetal indications.|At time of decision for delivery|Per protocol - subjects that delivered vaginally||participants|||Number
729555|NCT00381004|Primary|Number of Participants With Overall Response Includes Complete Remissions, Partial Remission, or Nodule Partial Remissions.|Complete Remission:Normal exam/No symptoms; Absolute lymphocyte count (ALC)</=4x10^9/L, Hb>11 g/dL, absolute neutrophil count (ANC)>/=1.5x109/L, & platelet count>100x109/L. Bone marrow:<30% lymphocytes aspirate no biopsy evidence disease; Disappearance palpable lymph nodes/spleen/liver, no new lesions. Partial Remission:ALC reduced 50%,either Hb>11 g/dL or 50% improvement (imp.) in deviation, or ANC>/=1.5x109/L or 50% imp., or platelet>100x109/L or 50% imp. in deviation from normal. Reduced 50% palpable lymph nodes/spleen/liver no new lesions. Nodular Partial Response:ALC</=4x109/L + Hb>11 g/dL, ANC>/=1.5x109/L & platelet count>100x109/L; <30% lymphocytes - bone marrow biopsy aspirate + lymphoid nodules;No palpable lymph nodes/spleen/liver tumors without new lesions. Progressive Disease:50% increase (incr.) ALC>10x109/L twice; tumor lesion incr. 50% over entry or responder size at time max regression &/or appearance new malignant disease; Reappearance bone marrow disease.|Baseline to 6 Months|||Participants|||Number
729556|NCT00381004|Secondary|Number of Participants Progression-free|Participants progression free as measured at six months following start of treatment. Criteria for Progressive Disease (PD): Peripheral blood: 50% increase in ALC with a level > 10 x 109/L on at least 2 occasions 2 weeks apart. Tumor: An increase of a lesion by 50% over the size present at entry on study or for patients who respond, the size at the time of maximum regression and/or the appearance of new areas of malignant disease. Reappearance of bone marrow disease. A deterioration in performance status or increasing symptoms do not constitute disease progression.|6 months or until disease progression if earlier|||participants|||Number
729557|NCT00381004|Primary|Participant Overall Response Rate (ORR) at 6 Months Includes Complete Remissions, Partial Remission, or Nodule Partial Remissions.|Complete Remission:Normal exam/No symptoms; Absolute lymphocyte count (ALC)</=4x10^9/L, Hb>11 g/dL, absolute neutrophil count (ANC)>/=1.5x109/L, & platelet count>100x109/L. Bone marrow:<30% lymphocytes aspirate no biopsy evidence disease; Disappearance palpable lymph nodes/spleen/liver, no new lesions. Partial Remission:ALC reduced 50%,either Hb>11 g/dL or 50% improvement (imp.) in deviation, or ANC>/=1.5x109/L or 50% imp., or platelet>100x109/L or 50% imp. in deviation from normal. Reduced 50% palpable lymph nodes/spleen/liver no new lesions. Nodular Partial Response:ALC</=4x109/L + Hb>11 g/dL, ANC>/=1.5x109/L & platelet count>100x109/L; <30% lymphocytes - bone marrow biopsy aspirate + lymphoid nodules;No palpable lymph nodes/spleen/liver tumors without new lesions. Progressive Disease:50% increase (incr.) ALC>10x109/L twice; tumor lesion incr. 50% over entry or responder size at time max regression &/or appearance new malignant disease; Reappearance bone marrow disease.|Baseline to 6 Months|||Percentage of Participants|||Number
729558|NCT00381043|Secondary|% Compliant With Medication|% of individuals with evidence for 80% compliance with medication based on returned blister packs and weekly diaries.|12 weeks|||percentage of participants|||Number
729559|NCT00381043|Secondary|Clinical Global Impression Scale|Range of overall severity of illness: 1, normal, not at all ill; 2, borderline ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill|12 weeks|||units on a scale||Standard Deviation|Mean
729560|NCT00381043|Secondary|% Heavy Drinking Days During Trial|% of Heavy drinking days (5 or more drinks/d for a man or 4 or more drinks/d for a woman) over the 12 weeks of the trial.|12 weeks|||percentage of heavy drinking days||Standard Deviation|Mean
729561|NCT00381043|Secondary|Percent With Complete Abstinence|% of subjects with no drinking during the 12 week treatment trial|12 weeks|||percentage of participants|||Number
729562|NCT00381043|Primary|Percent Days Abstinent|%Days without any alcohol consumption over the treatment period|12 weeks|||percentage of days||Standard Deviation|Mean
729563|NCT00381043|Primary|% Dropout|Percentage of participants who dropped out of study by drug condition|12 weeks|||percentage of participants|||Number
729564|NCT00381043|Secondary|Retention|Number of individuals retained in the trial by acamprosate vs placebo group|12 weeks|||participants|||Number
729565|NCT00381095|Secondary|Change From Baseline in Eastern Cooperative Oncology Group Performance (ECOG) Status Scale at Day 28|ECOG - assessed disease progression and how disease affected the daily living abilities of the participant and determined appropriate treatment and prognosis. Graded 0 (fully active able to carry on all pre-disease performance without restrictions) to 5 (dead). Change was day 28 minus baseline.|Baseline, Day 28 or ET|Data not analyzed due to early study termination.||Scores on a scale||Standard Deviation|Mean
729566|NCT00381095|Secondary|Change From Baseline in Opioid-Related Symptoms Distress Scale (OR-SDS) at Day 14 and Day 28|OR-SDS included OR-SDS individual items by dimension of frequency (rarely to almost constantly), severity (slight to very severe), and degree of bother (not at all to very much), number of episodes of retching/vomiting, OR-SDS dimension composite and overall composite scores. Change was scores at occurance minus score at baseline.|Baseline, Day 14, Day 28 or ET|Data not analyzed due to early study termination.||Units on a scale||Standard Deviation|Mean
729567|NCT00381095|Secondary|Patient Global Impression of Change (PGIC)|PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse).|Weeks 2 and 4 or ET|ITT; LOCF; n=number of evaluable participants analyzed at each time point; N= the number of participants with evaluable data analyzed||Units on a scale||Standard Deviation|Mean
729568|NCT00381095|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Week 4|HADS: participant rated questionnaire with 2 subscales. HADS-Anxiety assessed generalized anxiety (anxious mood/ restlessness/ anxious thoughts/panic attacks); HADS-Depression assessed lost interest/diminished pleasure response (lowering of hedonic tone). Each subscale has 7 items which ranged from 0 (no presence of anxiety or depression) to 3 (severe feeling anxiety/depression). Total 0-21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms. Change was week x minus baseline.|Baseline, Week 4 or ET|ITT; LOCF; n= number of evaluable participants analyzed at each time point; N= number of participants with evaluable data analyzed; individual symptoms not analyzed||Units on a scale||Standard Deviation|Mean
729569|NCT00381095|Secondary|Change From Pre-Baseline in Total Daily Dose of Morphine Equivalents Day 0 Through Day 28|IR and SR formulations separately and combined. Change was day x minus baseline.|Baseline, Day 0 through Day 28 or ET|Data not analyzed due to early study termination.||mg/day||Standard Deviation|Mean
729570|NCT00381095|Secondary|Change From Baseline in Total Daily Dose of Opioids Day 0 Through Day 28|Change from baseline in total daily dose of opioids immediate release (IR), sustained release (SR) formulations separately and combined.|Baseline, Day 0 through Day 28 or ET|Data no analyzed due to early study termination.||milligrams/day (mg/day)||Standard Deviation|Mean
729572|NCT00381095|Secondary|Change From Baseline in mBPI-sf Interference Index Score at Week 4|m-BPI-sf: participant-rated 11 point Likert rating scale ranging from 0 (does not interfere) to 10 (completely intereres) with functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Change was score at each observation minus baseline score.|Baseline, Week 4 or ET|ITT; LOCF; n= number of evaluable participants analyzed at each time point; N= number of participants with evaluable data analyzed||Units on a scale||Standard Deviation|Mean
729573|NCT00381095|Secondary|Change From Baseline in Modified Brief Pain Inventory (mBPI-sf) Pain Severity Index Score at Week 4|m-BPI-sf: participant rated 11-point Likert rating scale ranging from 0 (no pain) to 10 (worst pain possible). Pain severity index was the mean of item scores 1, 2, 3, and 4 (worst, least, average and current pain scores). Change was scores at observation minus scores at baseline.|Baseline, Week 4 or ET|ITT; LOCF= Last observation carried forward; n= number of evaluable participants analyzed at each time point; N= number of participants with evaluable data analyzed||Units on a scale||Standard Deviation|Mean
729574|NCT00381095|Secondary|DAAC From Baseline in Daily Worst Pain 14 Days After Fixed Dosing Date Up to Day 28|DAAC from baseline in the daily worst pain based on the NRS Worst Pain at Reference Site score collected from participant’s daily diary 14 days after dosing stabilized (fixed dosing date) up to Day 28. Pain rated on an 11 point scale ranged from 0 (no pain) to 10 (worst possible pain). DAAC defined as AUC of daily worst pain score divided by pain measurement duration. Change was week x minus baseline.|Baseline, 14 Days After Fixed Dosing Date up to Day 28 or ET|ITT; N= number of participants with evaluable data analyzed||Units on a scale||Standard Deviation|Mean
729575|NCT00381095|Secondary|DAAC From Baseline in Daily Worst Pain, Day 1 to End of Dose Adjustment|DAAC from baseline in the daily worst pain based on the NRS Worst Pain at Reference Site score collected from participant’s daily diary. Pain rated on an 11 point scale ranged from 0 (no pain) to 10 (worst possible pain). DAAC defined as AUC of daily worst pain score divided by pain measurement duration. Change was week x minus baseline.|Baseline, Day 1 to End of Dose Adjustment or ET|ITT; N= number of participants with evaluable data analyzed||Units on a scale||Standard Deviation|Mean
729576|NCT00381095|Secondary|DAAC From Baseline in Daily Worst Pain, Days 1 Through 28|DAAC from baseline in the daily worst pain based on the NRS Worst Pain at Reference Site score collected from participant’s daily diary. Pain rated on an 11 point scale ranged from 0 (no pain) to 10 (worst possible pain). DAAC defined as AUC of daily worst pain score divided by pain measurement duration. Change was week x minus baseline.|Baseline, Days 1 through 28 or ET|ITT; N= number of participants with evaluable data analyzed||Units on a scale||Standard Deviation|Mean
729577|NCT00381095|Primary|Duration Adjusted Average Change (DAAC) From Baseline in Daily Worst Pain, Fixed Dosing Date to Day 28|DAAC from baseline based on Numeric Rating Scale (NRS) score for Worst Pain at Reference site from the last day dose adjustment was needed (fixed dosing date) to day 28. DAAC defined as area under the curve (AUC) of change in worst pain divided by pain measurement duration. Pain rated on an 11 point scale ranged from 0 (no pain) to 10 (worst possible pain). Change was week x minus baseline.|Baseline, Fixed Dosing Date to Day 28 or Early Termination (ET)|Intent-To-Treat population (ITT): all randomized participants for whom at least one post-baseline efficacy evaluation was obtained; N= the number of participants with evaluable data analyzed; n= number of participants with evaluable data at the specific time point.||Units on a scale||Standard Deviation|Mean
729578|NCT00381238|Secondary|Number of Participant's With Hematology Parameters of Clinical Concern|Participant data for clinical concern hematology parameters, were reported for hematocrit (Hct) (unit:1): low concern (LC) and high concern (HC) values as 0.8 and 1.2 respectively, hemoglobin (Hb) (unit: gram per deciliter): LC and HC values as value for female (F) 10 (AB) , value for male (M) 11; and value for F 16.5 (AB), value for M 18 respectively; lymphocytes absolute(LA) (unit: giga cells per litre [GI/L]) : LC and HC value as 0.75 and 1.5 respectively; monocytes absolute (MA) (unit: GI/L) LC and HC value as 0.75 and 2 respectively, platelet count (PC) (unit: x103/mm3): LC and HC value as 100 (AB) and 500(AB) respectively, red blood cell count (RBC) (unit: x106 micro litre): LC and HC value as 0.8 and 1.2 respectively, segmented neutrophils absolute (SNA) (unit: GI/L) LC and HC value as 0.75 and 1.3 respectively, total neutrophils absolute (TNA) (unit : GI/L) LC and HC value as 0.75 and 1.5 respectively; White blood cell (WBC) (unit: GI/L) LC and HC value as 3 and 15.|Up to Wk 50|All subjects population. ‘n’ is participants available at the particular time of assessment which were included in analysis.||participant|||Number
729579|NCT00381238|Secondary|Number of Participants With Clinical Chemistry Parameters of Clinical Concern-lipids|Participant data for clinical concern lipid parameters for Total cholesterol, high density lipoprotein, low density lipoprotein, triglycerides was to be collected. However this data was not collected.|Up to Wk 50|All subject population. The data for 'The number of participants with clinical chemistry parameters of clinical concern- Lipids' was not collected.|||||
729580|NCT00381238|Secondary|Number of Participants With Clinical Chemistry Parameters of Clinical Concern|The data for participants for clinical parameters, with values only of potential clinical concern (PCI) were reported for creatine, creatinine kinase(CK), urea and glucose. Creatinine(unit: micromoles per litre) : low concern and high concern values were considered as 22 absolute value (AB) (<50% lower limit of RR ) and 155 (AB) (>125% upper limit of RR) respectively. CK (unit: international unit per litre ): low concern value and high concern values was none and 1.25 respectively. Glucose (unit: millimole per litre): low concern and high concern values were considered as 3.6 (AB) and 7.8 (AB) respectively.|Up to Wk 50|All subjects population. 'n’ is participants available at the particular time of assessment which were included in analysis.||participants|||Number
729581|NCT00381238|Secondary|Mean Change From Baseline in Vital Signs- Weight|The weight for the participant, was measured without wearing shoes and with light clothing. There was no particular RR, reported for weight; however, the increase from baseline was reported to be >=7 % and the decrease also reported as >=7 %. The values as of potential clinical concern were ‘both’ outside of RR, or met a change from baseline criterion.|Baseline (Wk 0) to Wk 50|All subject population. ‘n’ is participants available at the particular time of assessment which were included in analysis.||kilograms||Standard Deviation|Mean
729595|NCT00381303|Secondary|Descriptive Statistics of [TLOVR Non-virologic Failure (VF) Censored] - VL < 50 HIV-1 RNA by Race|TLOVR non-virologic failure (VF) censored. This imputation method differs from the TLOVR algorithm, because subjects that dropped out for reasons other than virologic failure were censored from the time of discontinuation onwards.|Week 48|TLOVR Non-virologic Failure(VF) Censored||participants|||Number
729582|NCT00381238|Secondary|Number of Participants With Vital Signs of Clinical Concern.|The data for number of participants with vital sign data, outside the range of potential clinical concern for SBP, DBP, HR and body weight were reported. The values as of potential clinical concern were ‘both’ outside of reference range or met a change from baseline criterion. The RR, for SBP was 90-140 mmHg for which the increase from baseline was reported to be >= 40 mmHg and decrease from baseline reported as >=30 mmHg; the RR for DBP was 50-90 mmHg for which the increase from baseline was reported to be >= 30 mmHg and decrease from baseline reported as >=20 mmHg; and the RR, for HR was 50-100 bpm for which the increase from baseline was reported to be >= 30 bpm and the decrease from baseline reported as >=30 bpm. The data of number of participants with > clinical concern range (CCR) or < CCR were reported.|Up to Wk 50|All subject population. ‘n’ is participants available at the particular time of assessment which were included in analysis.||participants|||Number
729583|NCT00381238|Secondary|Mean Change From Baseline in Vital Signs-heart Rate (HR)|The HR for the participant’s, were collected after the participant sat quietly for at least five minutes. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. The HR was measured in beats per minute (bpm).|Baseline (Wk 0) to Wk 50|All subject population. ‘n’ is participants available at the particular time of assessment which were included in analysis.||bpm||Standard Deviation|Mean
729584|NCT00381238|Secondary|Mean Change From Baseline in Vital Signs- Systolic and Diastolic Blood Pressure|Participants systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured in mm of mercury (mmHg). These were collected after the participant sat quietly for at least five minutes. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values.|Baseline (Wk 0) to Wk 50|All subject population. ‘n’ is participants available at the particular time of assessment which were included in analysis.||mmHg||Standard Deviation|Mean
729585|NCT00381238|Secondary|Number of Participants With AE of Peripheral Edema by Grade|Participants with AE of peripheral edema were evaluated. The test was performed by firmly pressing the thumb anterior to the participants ankle until further pressure produced no greater indentation. The depth of the pit was estimated and it was graded using below 5 point scale; where estimated depth of indentation corresponded to a particular grade (G). G 0 as depth of <1 millimeter (mm); G1 as depth of 1-2 mm; G2 as depth of 3-5 mm; G3 as depth of 6-10 mm; and G4 as depth of > 10 mm. The data for only the participants who had peripheral edema on more than one visit, then their most severe G were presented.|Up to Wk 50|All subject population||participants|||Number
729586|NCT00381238|Secondary|Number of Participants With SAEs|An SAE, is any untoward medical occurrence, that at any dose may result in death, is life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability or incapacity, is congenital anomaly or birth defect, and medically important events. The number of participants with any SAE, were reported.|From start of study medication (Wk 0) to Wk 50|All subject population||participants|||Number
729587|NCT00381238|Secondary|Mean Change From Baseline in Mini Mental State Examination (MMSE) Total Score|The MMSE, is a score scale which consists of 11 tests of orientation (to time and place), memory (recent and immediate), concentration, language and praxis. The scoring ranged from 0 to 30, with lower scores indicative of greater cognitive impairment (more severe disease) and higher scores indicative less cognitive impairment (less severe disease). The total score was calculated by summing the scores from each of the tests. The investigator questioned the participants individually with set of questions and scored the participant, based on his performance. The baseline was defined as Wk 0. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values.|From baseline to Wk 48|Intent to treat (ITT). The ITT population consisted of all participants in the safety population who also had at least one post-dose efficacy assessment within this study.||score on scale||Standard Deviation|Mean
729588|NCT00381238|Primary|Number of Participants With Adverse Events (AE's)|An AE was defined as any untoward medical occurrence or clinical investigation in a participant, temporally associated with the use of a medicinal product, whether or not, considered related to the medicinal product. For marketed medicinal products, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. The number of participants with all AEs, drug related AEs, serious adverse events (SAEs), AE leading to permanent (prm) discontinuation (disc) of study drug or withdrawal were reported.|From start of study medication (Wk 0) to Wk 50|All subject population, is defined as all the participants who received at least one dose of study drug.||participants|||Number
729589|NCT00381303|Secondary|Descriptive Statistics of ETR Subgroup - Change From Baseline in CD4+ Cell Count Using the Imputation Method of LOCF|The Etravirine-TMC125 (ETR Subgroup population was defined as all ITT subjects who took at least 1 dose of ETR). The Last Observation Carried Forward (LOCF) imputation method was applied.|Week 48|Etravirine-TMC125 (ETR Subgroup) Intention to Treat population (ITT)||x10^6 Cells/L||Standard Error|Mean
729590|NCT00381303|Primary|Number of TLOVR Non-virologic Failure (VF) Censored - VL < 50 HIV-1 RNA Subjects by Sex|TLOVR non-virologic failure (VF) censored. This imputation method differs from the TLOVR algorithm, because subjects that dropped out for reasons other than virologic failure were censored from the time of discontinuation onwards.|Week 48|TLOVR non-virologic failure (VF) censored||participants|||Number
729591|NCT00381303|Secondary|Descriptive Statistics of Change From Baseline in CD4+ Cell Count Using the Imputation Method of Last Observation Carried Forward (LOCF)|Last Observation Carried Forward (LOCF) imputation method applied.|Week 48|ITT LOCF||x10^6 cells/L||Standard Error|Mean
729592|NCT00381303|Secondary|Descriptive Statistics of ETR Subgroup - Change From Baseline in CD4+ Cell Using Observed Values|The Etravirine-TMC125 (ETR Subgroup population was defined as all ITT subjects who took at least 1 dose of ETR)|Week 48|Etravirine-TMC125 (ETR Subgroup) Intention to Treat population (ITT)||x10^6 cells/L||Standard Error|Mean
729593|NCT00381303|Secondary|Descriptive Statistics of Change From Baseline in CD4+ Cell Count Using Observed Values|Observed obsevations have no imputation methods applied.|Baseline, Week 48|ITT||x10^6 cells/L||Standard Error|Mean
729594|NCT00381303|Secondary|Descriptive Statistics of ETR Subgroup [TLOVR Non-virologic Failure (VF) Censored] - VL < 50 HIV-1 RNA|"The Etravirine-TMC125 (ETR Subgroup population was defined as all ITT subjects who took at least 1 dose of ETR)
TLOVR non-virologic failure(VF) censored. This imputation method differs from the TLOVR algorithm, because subjects that dropped out for reasons other than virologic failure were censored from the time of discontinuation onwards."|Week 48|Etravirine-TMC125 (ETR) Subgroup [TLOVR Non-virologic Failure (VF) Censored]||participants|||Number
729598|NCT00381303|Primary|Number of Viral Load (VL) < 50 HIV-1 RNA Copies/mL (Time to Loss of Virologic Response[TLOVR]) Subjects by Sex|TLOVR - responders/non-responders per FDA TLOVR response algorithm. A subject was considered a responder at that time point and that subsequent. A subject was considered a non-responder at a time point in the following situations: discontinued treatment at that time point, a rebound value at that time point and that subsequent or at that time point and that followed by treatment discontinuation, intermittent missing values were considered a response if the immediately preceding and following visits were a response, rebound at earlier time point, or any new, unplanned ARV except in tolerability|Week 48|Intention to Treat (ITT)||participants|||Number
729639|NCT00381888|Secondary|Number of Patients Who Achieved Thromboembolism Prophylaxis at Week 4.|This is a count of patients who did not have a clot (thromboembolism) occur during the 4 weeks of study - attributed to the use of Fondaparinux (study dry). Prophylaxis is a measure taken for the prevention of a disease or condition.|Week 4|These patients completed the study and are considered evaluable for this outcome measure.||Participants|||Number
729640|NCT00381888|Primary|Number of Patients With Venous Thromboembolism at Week 4|Venous thromboembolism is the formation of a blood clot (thrombus) inside a blood vessel, obstructing the flow of blood through the circulatory system.|Week 4 (Days 28-35)|The number includes those patients who completed the study and are evaluable for this outcome measure.||Participants|||Number
729641|NCT00381940|Secondary|Biological Markers|Assessing baseline NF-kB protein levels in tumor tissue|Before, during, and after treatment||||||
729626|NCT00381810|Primary|Percentage of Participants With at Least 1 Serious Adverse Event|A serious adverse event is defined as an adverse event that results in death, is life threatening, requires hospitalization, results in significant disability, results in birth defect, or is considered a significant medical event by the investigator.|Baseline to the end of the study (up to 52 weeks)|||Percentage of participants|||Number
729627|NCT00381849|Primary|Volume of Kidney Stones as Measured on Computerized Tomography|Measurement of kidney stone volume in cubic millimeters.|Baseline, approximately 52 weeks after baseline|One subject was excluded from CT analysis because of bilateral stone removal surgery during the study.||mm^3||Standard Deviation|Mean
729628|NCT00381849|Primary|Stone Density as Measured by Agatston Score Via Computerized Tomography|Agatston results are a measure of calcium typically used for measuring coronary artery calcification.|Baseline, approximately 52 weeks after baseline|One subject was excluded from CT analysis because of bilateral stone removal surgery during the study||Agatston Score||Standard Deviation|Mean
729629|NCT00381849|Primary|24 Hour Urinary Cystine Excretion||baseline, after 6 weeks treatment on placebo, after 6 weeks treatment on cystone, at end of 46 weeks of open label cystone treatment|Cystine excretion was not applicable to the Calcium Stone subjects.||mcmol/24 hours||Standard Deviation|Mean
729630|NCT00381849|Secondary|Change in Stone Burden as Assessed by Radiologist at One Year|Stone burden will be quantitated using the stone quantification protocol currently available at Mayo that quantitates kidney stones both by volume and by density measured in Agatston units.|Baseline, approximately 52 weeks after baseline|One subject in the Calcium group was excluded from the CT analysis because of bilateral stone removal surgery during the study.||Kidneys|||Number
729631|NCT00381849|Primary|24 Hour Urine Supersaturation of Calcium Phosphate (Hydroxyapatite)|Urine is often supersaturated, which favors precipitation of crystalline phases such as calcium oxalate. However, crystals do not always form in supersaturated urine because supersaturation is balanced by crystallization inhibitors that are also present. Supersaturation is calculated by measuring the concentration of all the ions that can interact. Once these concentrations are known, a computer program can calculate the theoretical supersaturation with respect to the important crystalline phases, eg, calcium oxalate.|baseline, after 6 weeks treatment on placebo, after 6 weeks treatment on cystone, at end of 46 weeks of open label cystone treatment|Hydroxyapatite was not analyzed for the Cystine Stone subjects.||KJoules/mol||Standard Deviation|Mean
729632|NCT00381849|Primary|24 Hour Urine Supersaturation of Calcium Phosphate (Brushite)|Urine is often supersaturated, which favors precipitation of crystalline phases such as calcium oxalate. However, crystals do not always form in supersaturated urine because supersaturation is balanced by crystallization inhibitors that are also present. Supersaturation is calculated by measuring the concentration of all the ions that can interact. Once these concentrations are known, a computer program can calculate the theoretical supersaturation with respect to the important crystalline phases, eg, calcium oxalate.|baseline, after 6 weeks treatment on placebo, after 6 weeks treatment on cystone, at end of 46 weeks of open label cystone treatment|Brushite was not analyzed for the Cystine Stone subjects.||KJoules/mol||Standard Deviation|Mean
729633|NCT00381849|Primary|24 Hour Urine Supersaturation of Calcium Oxalate (CaOx)|Urine is often supersaturated, which favors precipitation of crystalline phases such as calcium oxalate. However, crystals do not always form in supersaturated urine because supersaturation is balanced by crystallization inhibitors that are also present. Supersaturation is calculated by measuring the concentration of all the ions that can interact. Once these concentrations are known, a computer program can calculate the theoretical supersaturation with respect to the important crystalline phases, eg, calcium oxalate.|baseline, after 6 weeks treatment on placebo, after 6 weeks treatment on cystone, at end of 46 weeks of open label cystone treatment|CaOx was not analyzed for the Cystine Stone subjects.||KJoules/mol||Standard Deviation|Mean
729634|NCT00381862|Secondary|Percentage of Patients With no Emesis and no Rescue Therapy Within 5 Days of the First Course of Chemotherapy||within 5 days of chemotherapy||||||
729635|NCT00381862|Secondary|To Assess the Safety of the Combination of Aprepitant, Palonosetron, and Dexamethasone in the Colorectal Cancer(CRC) Population in the First and Subsequent Cycles of Chemotherapy.||Duration of time patient is on study||||||
729636|NCT00381862|Secondary|Effects of Aprepitant on Nausea, Appetite, Taste Changes, (Via Visual Analogue Scale [VAS]), Nutritional Intake, and Mucositis in the Colorectal Cancer (CRC) Population.||Duration of time the patient is on study||||||
729637|NCT00381862|Secondary|Percentage of Patients With no Emesis and no Rescue Therapy During Repeated Courses of Chemotherapy||Duration of time that the patient is on study||||||
729638|NCT00381862|Primary|Number of Participants With no Emesis and no Rescue Therapy Within 5 Days of Receiving FOLFOX and FOLFIRI in the First Cycle of Chemotherapy.||Up to 24 weeks|||Participants|||Number
729642|NCT00381940|Secondary|Rate of Successful PBSC Harvest|Success is defined as the ability to harvest 2x10^6 CD34+ cells/kg within 5 collection days.|After 2 cycles||||||
729643|NCT00381940|Secondary|Induction Success Rate|Induction success is defined as achieving CR or PR without a targeted primary toxicity.|After 2 cycles and 4 cycles||||||
729646|NCT00381940|Primary|Complete Response (CR)|CR is defined as at least 80% reduction in the sum of the products of the perpendicular diameters of each of the nodal masses or return to normal size, along with negative nuclear medicine imaging.|After 2 cycles of treatment|Analysis population includes all patients evaluable for tumor response. Three enrolled patients are excluded: 1 ineligible, 1 who was removed from treatment after 1 dose of bortezomib, and 1 who received only 1/3 dose of bortezomib in cycle 1 and part of cycle 2 due to pharmacy error.||participants|||Number
729647|NCT00382018|Other Pre-specified|Correlation of CTC Levels With Breast Cancer Tumor Markers||Baseline, Weeks 4, 8, 13, 25, 37 and at progression||||||
729648|NCT00382018|Secondary|Number of Patients With Adverse Events That Are Related to Study Drugs|Adverse Events (AEs) are reported by CTCAE Version 3.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.|Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression|Patients in 'Arm A (Baseline CTCs < 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. And only patients who were evaluable for Adverse Event Assessment were included in the following analysis results.||Participants|||Number
729649|NCT00382018|Primary|Progression Free Survival|From date of registration to date of first documentation of progressive disease, death due to any cause or symptomatic deterioration, whichever occurs first. Patients last known to be alive and progression-free are censored at date of last contact.|every 3 months until progression|Three patients in Arm C were judged as progressing on day 22 and were excluded from the PFS analysis but were included in the OS analysis.||months||95% Confidence Interval|Median
729650|NCT00382018|Primary|Overall Survival|From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Every 3 months until progression then every 6 months for 5 years or until death|||months||95% Confidence Interval|Median
729651|NCT00382018|Primary|Progression-free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|every 3 months until progression. From date of registration to date of first documentation of progressive disease, death due to any cause or symptomatic deterioration, whichever occurs first, assessed up to five years.|Three patients in Arm C2 were judged as progression on day 22 and were excluded from the PFS analysis but were included in the OS analysis.||months||95% Confidence Interval|Median
729652|NCT00382018|Primary|Overall Survival|From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Every 3 months until progression then every 6 months for 5 years or until death|||months||95% Confidence Interval|Median
729653|NCT00382031|Secondary|Progression Free Survival (PFS)|PFS (defined as the time from randomization until disease progression or death). The progression events were defined by well-documented and verifiable imaging data. In case of censoring, the date of censoring had to be the last time point documenting the status of the patient.|From randomization until disease progression or death, assessed up to 41 months.|The full analysis set (FAS) was based on the intent-to-treat principle and thus comprised all randomized patients. The FAS was used for evaluation of all efficacy endpoints and was the primary analysis population.||weeks||95% Confidence Interval|Median
729654|NCT00382031|Secondary|Duration of Response|Duration of response defined as the time from the first date where measurement criteria for complete or partial response (whichever status is recorded first) are met until the first date that death, recurrence or progressive disease is objectively documented.|Time from complete or partial response until death, recurrence or progressive disease, assessed up to 41 months.|The full analysis set (FAS) was based on the intent-to-treat principle and thus comprised all randomized patients. The FAS was used for evaluation of all efficacy endpoints and was the primary analysis population.||month||95% Confidence Interval|Median
729655|NCT00382031|Secondary|Objective Tumor Response|Objective tumor response assessed according to Response Evaluation Criteria in Solid Tumours (RECIST v 1.0) J Natl Cancer Inst 2000;92:205-16 assessed by CT/MRI. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the longest diameter of target lesions; Overall Response (OR), CR+PR|From date of randomization until the date of death from any cause, assessed up to 41 months.|The full analysis set (FAS) was based on the intent-to-treat principle and thus comprised all randomized patients. The FAS was used for evaluation of all efficacy endpoints and was the primary analysis population.||participants|||Number
729656|NCT00382031|Primary|Overall Survival|A patient’s overall survival was defined as the time from the date of randomization until the date of death from any cause, assessed up to 41 months. Overall survival was censored if the patient was lost to follow-up or refused to continue in the trial.|From randomization until death|The full analysis set (FAS) was based on the intent-to-treat principle and thus comprised all randomized patients. The FAS was used for evaluation of all efficacy endpoints and was the primary analysis population.||months||95% Confidence Interval|Median
729657|NCT00382109|Secondary|Chimerism|Evaluate the relative contribution of resistance by ALL blasts to the donor immune response as a cause of relapse post transplantation.|Up to 12 months|We are not able to perform this analysis given the low numbers of blast samples available.|||||
729658|NCT00382109|Secondary|Relative Contribution of ALL Blasts to the Donor Immune Response as a Cause of Relapse Pre-Transplantation (MRD)|An event is defined as relapse; relapse risk is reported. Not able to be performed given the low numbers of blast samples available.|At 2 months|The two treatment regimens were intended to be analyzed together (combined data), as pre-specified in the study protocol. However, we are not able to perform this analysis given the low numbers of blast samples available.|||||
729659|NCT00382109|Secondary|Relative Contribution of ALL Blasts to the Donor Immune Response as a Cause of Relapse Post Transplantation (Correlating Development of aGVHD With Relapse)|An event is defined as relapse; estimated probability of relapse.|At 1 year|Number at risk among no aGVHD and number at risk among aGVHD at 1 year. The two treatment regimens were intended to be analyzed together (combined data), as pre-specified in the study protocol, therefore results are not reported for each Arm of study.||percentage of participants|||Number
729820|NCT00383331|Secondary|Progression Free Survival|baseline to measured progressive disease|baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up|||months||95% Confidence Interval|Median
729660|NCT00382109|Secondary|Relative Contribution of Resistance by Acute Lymphoblastic Leukemia (ALL) Blasts to Cytolytic Therapy (e.g., Chemotherapy/Irradiation) as a Cause of Relapse Post-transplantation|An event is defined as relapse or transplant-related mortality.|Up to 1 year|We made a large number of xenograft models but were not able to correlate resistance to rapamycin in mice with outcome on the trial with the numbers that we had. For this reason, no specific publications addressing this aim were put forward.|||||
729661|NCT00382109|Secondary|Estimated Rate of Overall Chronic Graft VS Host Disease|Chronic graft vs host disease is defined in APPENDIX III of study protocol.|At 2 years|2 ineligible patients on experimental arm excluded from analysis. Definition of Chronic GVHD: APPENDIX III: DEFINING CHRONIC GRAFT VS. HOST DISEASE (FROM BMT CTN MOP SEPT. 2005) on page 97 protocol.||percentage of participants||95% Confidence Interval|Number
729662|NCT00382109|Secondary|Estimated Rate of Acute Graft VS Host Disease (GVHD)|Any grade acute graft vs host disease (defined in APPENDIX II study protocol).|At 200 days|2 ineligible patients on experimental arm excluded from analysis. Definition of Acute GVHD: APPENDIX II: COG STEM CELL COMMITTEE CONSENSUS GUIDELINES FOR ESTABLISHING ORGAN STAGE AND OVERALL GRADE OF ACUTE GRAFT VERSUS HOST DISEASE (GVHD) page 90-96 protocol.||percentage of participants||95% Confidence Interval|Number
729663|NCT00382109|Secondary|Estimated Transplant Related Mortality Percentage|Death in a patient who had not relapsed after transplant is defined as transplant-related mortality event.|100 days|2 ineligible patients on experimental arm excluded from analysis.||percentage of participants||95% Confidence Interval|Number
729664|NCT00382109|Secondary|Rate of Relapses|An event is defined as relapse.|At 2 years|2 ineligible patients on experimental arm excluded from analysis.Testing for recurrent malignancy in the blood, marrow or other sites will be used to assess relapse after transplantation. For the purpose of this study, relapse is defined by either morphological or cytogenetic evidence of ALL consistent with pre-transplant features.||percentage of participants||95% Confidence Interval|Number
729665|NCT00382109|Primary|Estimated Percentage of Participants With Event Free Survival|An event is defined as relapse or transplant-related mortality. Relapse is defined in section 3.3 study protocol.|at 2 years|Two ineligible patients on experimental arm excluded from analysis.||percentage of participants||95% Confidence Interval|Number
729666|NCT00382148|Secondary|Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs|All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0. All AEs that do not meet any of the criteria for serious should be regarded as nonserious AEs.|Through Week 52|safety-evaluable population||participants|||Number
729667|NCT00382148|Secondary|Food-allergic Reactions As Assessed by the Ewan Scale|"The Ewan scale has five ascending grades of severity from Grade 1 to Grade 5 (as well, there is a possible value of Not Applicable). Following a report of an allergic reaction to food on a patient-reported questionnaire, the reaction is graded by the study coordinator or Principle Investigator"|Through Week 52|safety-evaluable population||participants|||Number
729668|NCT00382148|Secondary|Food Allergen Exposure, Assessed on Patient-reported Questionnaire|"Participants were asked to record every 4 weeks in the food-related allergic event questionnaire: Whether you were exposed to peanut, tree nut (cashew, almond, etc.), shellfish (shrimp, crab, etc.), eggs, milk, or other (please specify) and Did you have a reaction? (Yes/No)."|Every 4 weeks through Week 52|||participants|||Number
729669|NCT00382148|Primary|Serious Adverse Events|All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0. An SAE is defined as an adverse event that results in death, is life threatening, requires hospitalization, results in significant disability, results in birth defect, or is considered a significant medical event by the investigator|Through Week 52|Safety-analysis population||participants|||Number
729670|NCT00382174|Secondary|Wound Healing Effectiveness of Tβ4 Applied for up to 84 Days|Incidence of wound healing at the end of the study, Day 84|Up to 84 days|Analysis was per protocol,ITT, and using LOCF||Number of healed participants|||Number
729671|NCT00382174|Primary|Safety and Tolerability of Thymosin Beta 4 (Tβ4)Applied for up to 84 Days|All Treatment-Emergent Serious Adverse Events (SAEs) and AEs by treatment dose safety population|Up to 84 days|||participants|||Number
729672|NCT00382291|Primary|Children’s Yale-Brown Obsessive Compulsive Scale (CY-BOCS) Total Score|The CY-BOCS (Scahill et al., 1997) is a semi-structured, clinician rated instrument to measure OCD symptom severity in youth. The CY-BOCS contains a symptom checklist and a severity scale. Through the symptom checklist the clinician assesses current and past experiences of over 60 potential obsessions and compulsions. The Total Score represents the sum of obsession severity and compulsion severity which each consist of five clinician ratings on a Likert scale (range from 0 (none) to 4 (extreme), for time spent, interference, distress, resistance and control over symptoms). Summing of obsession and compulsion severity (range 0-20 on each) produces the Total CY-BOCS score (range 0-40, with 0 representing the best and 40 the worst outcome). Studies have documented good psychometric properties of the CY-BOCS (Gallant et al., 2008; Scahill et al., 1997; Storch et al., 2004).|Measured at Week 18 or End of Study|||units on a scale||Standard Deviation|Mean
729673|NCT00382291|Primary|Clinical Global Impression – Severity of Activation (CGI-SA)|The CGI-SA was adapted from the Clinical Global Impressions – Severity of Illness (CGI-SI) rating (Guy, 1976). The CGI-SI is commonly used in clinical studies of children and adults and has been extensively validated (Zaider et al., 2003). On the CGI-SA clinicians rate the severity of activation symptoms on a range from 0 (no activation) to 7 (extremely severe symptoms, functionally highly impaired and/or extreme distress). We report values representing Median+/-Std Dev for the maximum CGI-SA obtained over the course of study.|Measured at screening, baseline and weekly until end of week 8 after baseline, then monthly for two months and finally at end of study|Per protocol, Intent to treat||units on a scale||Standard Deviation|Median
729674|NCT00382408|Secondary|Percentage of Participants Showing ADV Type-7 Booster at Week 4|ADV-7 booster effect is defined as the development of ADV Type-7 neutralizing antibody at Week 4 (Day 26) that represented at least a fourfold increase in titer from baseline (Visit 0) in a participant whose baseline Type-7 titer is ≥1:4.|Baseline, Week 4|Type-7 ADV Booster Cohort included subjects who had a positive Type-7 ADV serum neutralizing antibody status at baseline (≥ 1:4) and at least one titer value for ADV Type-7 at the subsequent visits following study medication administration.||percentage of participants||95% Confidence Interval|Number
729675|NCT00382408|Secondary|Number of Participants With Wild Type-7 Adenovirus (ADV) Acute Respiratory Disease (ARD) -- ITT Cohort|For the oral Type-7 vaccine, the number of cases of ADV-7 acute respiratory disease (ARD) regardless of whether the participant was febrile or not. Therefore includes participants with one or more clinical signs and symptoms of ARD and throat culture positive for wild ADV Type-7 infection. This outcome used the intent-to-treat cohort.|Day 0 - Day 56|The intent-to-treat (ITT) cohort included all participants randomized and treated in the study.||participants|||Number
729676|NCT00382408|Secondary|Number of Participants With Wild Type-7 Febrile Adenovirus (ADV) Acute Respiratory Disease (ARD) -- ITT Cohort|For the oral Type-7 vaccine, a secondary outcome is the number of cases of ADV-7 febrile acute respiratory disease (ARD), defined as a subject with one or more clinical signs and symptoms of ARD and an oral temperature ≥ 100.5°F (38.06°C) and throat culture positive for wild ADV Type-7 infection. This outcome used the intent-to-treat cohort.|Day 0 - Day 56|The intent-to-treat (ITT) cohort included all participants randomized and treated in the study.||participants|||Number
729677|NCT00382408|Secondary|Percentage of Participants Showing ADV Type-4 Booster at Week 4|ADV-4 booster effect is defined as the development of ADV Type-4 neutralizing antibody at Week 4 (Day 26) that represented at least a fourfold increase in titer from baseline (Visit 0) in a participant whose baseline Type-4 titer is ≥1:4.|Baseline, Week 4|Type-4 ADV Booster Cohort included subjects who had a positive Type-4 ADV serum neutralizing antibody status at baseline (≥ 1:4) and at least one titer value for ADV Type-4 at the subsequent visits following study medication administration.||percentage of participants||95% Confidence Interval|Number
729678|NCT00382408|Secondary|Number of Participants With Wild Type-4 Adenovirus (ADV) Acute Respiratory Disease (ARD) -- ITT Cohort|For the oral Type-4 vaccine, the number of cases of ADV-4 acute respiratory disease (ARD) regardless of whether the participant was febrile or not. Therefore includes participants with one or more clinical signs and symptoms of ARD and throat culture positive for wild ADV Type-4 infection. This outcome used the intent-to-treat cohort.|Day 0 - Day 56|The intent-to-treat (ITT) cohort included all participants randomized and treated in the study.||participants|||Number
729679|NCT00382408|Secondary|Percentage of Participants Showing ADV-4 Seroconversion at Week 4|ADV-4 seroconversion was defined as the development of ADV Type-4 neutralizing antibody at Week 4 (Day 26) after study medication that represented at least a fourfold increase in titer from baseline (visit 0) in a subject whose baseline Type-4 titer was <1:4.|Week 4|Type-4 ADV Seroconversion Cohort: Included those subjects who had a negative Type-4 ADV serum neutralizing antibody status at baseline (<1:4) and at least one titer value for ADV-4 at the subsequent visits following vaccination.||percentage of participants||95% Confidence Interval|Number
729680|NCT00382408|Primary|Percentage of Participants Showing ADV-7 Seroconversion at Week 4|ADV-7 seroconversion was defined as the development of ADV Type-7 neutralizing antibody at Week 4 (Day 26) after study medication that represented at least a fourfold increase in titer from baseline (visit 0) in a subject whose baseline Type-7 titer was <1:4.|Week 4|Type-7 ADV Seroconversion Cohort: Included those subjects who had a negative Type-7 ADV serum neutralizing antibody status at baseline (<1:4) and at least one titer value for ADV-7 at the subsequent visits following vaccination.||percentage of participants||95% Confidence Interval|Number
729681|NCT00382408|Primary|Number of Participants With Wild Type-4 Febrile Adenovirus (ADV) Acute Respiratory Disease (ARD) -- ITT Cohort --- Day 11-56|For the oral Type-4 vaccine, the primary outcome is the number of cases of ADV-4 febrile acute respiratory disease (ARD), defined as a subject with one or more clinical signs and symptoms of ARD and an oral temperature ≥ 100.5°F (38.06°C) and throat culture positive for wild ADV Type-4 infection. This outcome used the intent-to-treat cohort; further, this outcome omitted ARD cases from Day 0-Day 10 because the protective effect of the vaccine was unlikely to take place during that time period.|Day 11 - Day 56|The intent-to-treat (ITT) cohort included all participants randomized and treated in the study.||participants|||Number
729682|NCT00382408|Primary|Number of Participants With Wild Type-4 Febrile Adenovirus (ADV) Acute Respiratory Disease (ARD) -- PP Cohort|For the oral Type-4 vaccine, the primary outcome is the number of cases of ADV-4 febrile acute respiratory disease (ARD), defined as a subject with one or more clinical signs and symptoms of ARD and an oral temperature ≥ 100.5°F (38.06°C) and throat culture positive for wild ADV Type-4 infection. This outcome used the per protocol cohort.|Day 0 - Day 56|The per-protocol (PP) cohort included all participants who met the eligibility criteria set forth in the protocol, did not have any significant violations or deviations from the protocol, and completed the final study visit (Day 56). Subjects who vomited within 24 hours after taking the study medication were excluded from the PP cohort.||participants|||Number
729683|NCT00382408|Primary|Number of Participants With Wild Type-4 Febrile Adenovirus (ADV) Acute Respiratory Disease (ARD) -- ITT Cohort|For the oral Type-4 vaccine, the primary outcome is the number of cases of ADV-4 febrile acute respiratory disease (ARD), defined as a subject with one or more clinical signs and symptoms of ARD and an oral temperature ≥ 100.5°F (38.06°C) and throat culture positive for wild ADV Type-4 infection. This outcome used the intent-to-treat cohort.|Day 0 - Day 56|The intent-to-treat (ITT) cohort included all participants randomized and treated in the study.||participants|||Number
729684|NCT00382590|Primary|Number of Participants With Response|Patient response defined by: Death, Resistant to Therapy [no major hematologic improvement using International Myelodysplastic Syndromes (MDS) Working Group (Cheson B, Bennett J, Kantarjian H et al, Blood 2006) criteria after a maximum of 4 courses], or Relapse.|Evaluated every 3 weeks, following 4 courses (16/24 weeks ) and till study end|The analysis was per intention to treat. One participant was inevaluable for response.||Participants|||Number
729685|NCT00382720|Secondary|Overall Survival (OS)|The number of months measured from the date of randomization to the date of death due to any cause.|up to a maximum of 36 months|248 participants in the full analysis population (FAP).||months||95% Confidence Interval|Median
729686|NCT00382720|Secondary|Best Overall Response Rate (ORR)|"Percentage of partial and complete responses, according to WHO criteria:
Complete Response: Disappearance of all known disease, determined by 2 observations not less than 4 weeks apart.
Partial Response: Decrease by at least 50% of the diameters of all measurable lesions, determined by 2 observations not less than 4 weeks apart."|every 8 weeks up to a maximum of 36 months|248 participants in the full analysis population (FAP).||percentage of participants||95% Confidence Interval|Number
729687|NCT00382720|Primary|Time to Progression|"The number of months measured from the day of randomization to the first tumor progression according to World Health Organization (WHO) criteria evaluation of cancer response, or death from any cause.
WHO Criteria for Progressive Disease: ≥ 25% increase in the size of at least one bidimensionally or unidimensionally measurable lesion."|every 8 weeks up to a maximum of 36 months|248 participants in the full analysis population (FAP).||Months||95% Confidence Interval|Median
729688|NCT00382733|Secondary|Best Overall Response|Best overall response is defined as the best response across all time points. Response was evaluated via changes from baseline in radiological tumor measurements performed after every two treatment cycles and at the end of treatment or time of disease progression. Response was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is >=30% decrease in the sum of the longest diameter (LD) of target lesions; Stable Disease (SD) is neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of >=20%; Progressive Disease (PD) is the increase in existing lesions or new lesions.|Best overall response was assessed after every 8 weeks of treatment and at the end of treatment or time of disease progression, up to 1 year.|All enrolled subjects were analyzed for this outcome.||participants|||Number
729689|NCT00382733|Secondary|Dose Limiting Toxicities (DLT)|DLTs were assessed using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. This measure reports the number of subjects who experienced DLT at each dose level during the dose finding portion of the study.|DLTs were assessed during the first cycle of treatment (days 1-28).|Number of participants analyzed refers to those for whom DLT information was available during the dose finding portion of the study.||participants|||Number
729690|NCT00382733|Primary|Maximum Tolerated Dose (MTD) of Single Agent Metronomic Oral Topotecan|The MTD of metronomic oral topotecan was determined using a standard 3+3 dose escalation cohort design. The total sample and the number of subjects who receive each dose in this design depends on the frequency of dose limiting toxicities (DLTs)at each dose level. If 0 out of 3 subjects experience a DLT at a given dose level, 3 subjects will be enrolled at the next higher dose level. If greater than or equal to 2 subjects experience a DLT at a given dose level, dose escalation will be stopped. If 1 out of 3 subjects experience a DLT at a given dose level, 3 subjects are enrolled at the same dose level.|MTD was assessed during the first cycle of treatment (days 1-28).|DLT information was available for 3 subjects who received a topotecan dose of 0.25 mg/day, 3 subjects who received a topotecan dose of 0.50 mg/day, 3 subjects who received a topotecan dose of 0.75 mg/day, 3 subjects who received a topotecan dose of 1.0 mg/day, and 2 subjects who received a topotecan dose of 1.25 mg/day.||mg/day|||Number
729691|NCT00382785|Primary|Scores on the Quality of Life (QOL) Question on the Rotterdam Symptom Check List (RSCL).|The Rotterdam Symptom Checklist (RSCL) measures quality of life in cancer patients. The RSCL checklist includes a QOL life question on a scale of 1 (excellent) to 7 (extremely poor). This was used as a measure of overall QOL.|16 weeks|||Scores on a scale||Standard Error|Mean
729692|NCT00382785|Primary|Scores on the CES-D Scale|The Center for Epidemiologic Studies Depression Scale (CES-D) is a 20-item self-report scale widely used in the assessment of depression. Each item is given a rating of 0 to 3, with a potential range of 0 to 60 for the entire scale. Higher scores are associated with depression. The cutoff for the diagnosis of Major Depressive Disorder on the CES-D is 16. The instrument is a reliable measure (Alpha >.85) of depression|16 weeks|Same as number of participants analyzed||Scores on a scale||Standard Error|Mean
729693|NCT00382785|Primary|Scores on the Personal Resource Questionnaire 85.|The Personal Resource Questionnaire 85 (PRQ85), Part II measures perceived social support and consists of 25 items in a seven-point Likert format which are rated from seven (7) strongly agree, to one (1) strongly disagree. Scores range from 25 to 175 with higher scores indicative of higher levels of perceived social support. Alpha reliability of the PRQ 85 has been demonstrated at >.90|16 weeks|||Scores on a scale||Standard Error|Mean
729694|NCT00382863|Secondary|Days Alive Out of Hospital|Median number of days participants were not hospitalized within the first 12 months after enrollment. Within the Treatment Arm, hospitalization for the implant procedure was not included in this analysis.|12 months|Population is intent to treat.||days||Full Range|Median
729695|NCT00382863|Secondary|Serious Adverse Events - Actuarial Analysis|Kaplan-Meier actuarial time-to-first-event analysis of serious adverse events|12 months|Population is intent to treat.||participants|||Number
729696|NCT00382863|Secondary|Participants Experiencing Serious Adverse Events|Number of participants who experienced a serious adverse event (as classified by an independent Clinical Events Committee) within the first 12 months after enrollment|12 months|Population is intent to treat.||participants|||Number
729697|NCT00382863|Secondary|All-Cause Hospitalization - Actuarial Analysis|Kaplan-Meier actuarial time-to-first-event analysis of all-cause hospitalizations|12 months|Population is intent to treat.||participants|||Number
729698|NCT00382863|Secondary|All-Cause Hospitalization|Number of participants who experienced a hospitalization (for any cause) within the first 12 months after enrollment. Within the Treatment Arm, hospitalization for the implant procedure was not included in this analysis.|12 months|Population is intent to treat.||participants|||Number
729699|NCT00382863|Secondary|Heart Failure Hospitalization|Number of participants who experienced a heart failure hospitaliz (as classified by an independent Clinical Events Committee) within the first 12 months after enrollment.|12 months|Population is intent to treat.||participants|||Number
729700|NCT00382863|Secondary|Heart Failure Death - Actuarial Analysis|Kaplan-Meier actuarial time-to-event analysis of deaths classified, by an independent Clinical Events Committee, as due to heart failure|12 months|Population is intent to treat.||participants|||Number
729701|NCT00382863|Secondary|Heart Failure Death|Number of participants who died within 12 months of enrolling in the study and whose cause of death was classified, by an independent Clinical Events Committee, as heart failure|12 months|Population is intent to treat.||participants|||Number
729702|NCT00382863|Secondary|Technical Success (Number of Treatment Arm Participants Successfully Implanted)|"Technical success refers to the ability to successfully deliver a device onto the epicardial surface and leave the device in a satisfactory position. Participants who did not undergo an implant procedure were excluded from this analysis."|1 day|Population is as treated, treatment only.||participants|||Number
729703|NCT00382863|Secondary|Change in Left Ventricular End Systolic Diameter|The difference between each participant's baseline and 6-month echocardiographic measure of left ventricular end systolic diameter was calculated. The median change for each treatment arm is presented. A decrease in diameter indicates an improvement in the participant's structural heart failure.|baseline to 6 months|Population is intent to treat.||centimeters||Full Range|Median
729704|NCT00382863|Secondary|Change in Left Ventricular End Diastolic Diameter|The difference between each participant's baseline and 6-month echocardiographic measure of left ventricular end diastolic diameter was calculated. The median change for each treatment arm is presented. A decrease in diameter indicates an improvement in the participant's structural heart failure.|baseline to 6 months|Population is intent to treat.||centimeters||Full Range|Median
729705|NCT00382863|Secondary|Change in Ejection Fraction|The difference between each participant's baseline and 6-month echocardiographic measure of left ventricular ejection fraction was calculated. The median change for each treatment arm is presented.|baseline to 6 months|Population is intent to treat.||percent||Full Range|Median
729706|NCT00382863|Secondary|Change in Left Ventricular End Systolic Volume|The difference between each participant's baseline and 6-month echocardiographic measure of left ventricular end systolic volume was calculated. The median change for each treatment arm is presented. A decrease in volume indicates an improvement in the participant's structural heart failure.|baseline to 6 months|Population is intent to treat.||milliliters||Full Range|Median
729707|NCT00382863|Secondary|Change in Left Ventricular End Diastolic Volume|The difference between each participant's baseline and 6-month echocardiographic measure of left ventricular end diastolic volume was calculated. The median change for each treatment arm is presented. A decrease in volume is associated with an improvement in the participant's structural heart failure.|baseline to 6 months|Population is intent to treat.||milliliters||Full Range|Median
729708|NCT00382863|Secondary|Heart Failure Hospitalization - Actuarial Analysis|Kaplan-Meier actuarial analysis of heart failure hospitalization (as classified by an independent Clinical Events Committee) within the first 12 months after enrollment|12 months|Population is intent to treat.||participants|||Number
729709|NCT00382863|Secondary|Responder Analysis - Minnesota Living With Heart Failure (MLWHF) Quality of Life Overall Score|"A participant was considered a responder if the MLHF overall score had improved by at least 7 points at 12 months as compared to baseline. THE MLHF questionnaire evaluates the impact of heart failure (HF) on a subject's physical, emotional, social and mental aspects of quality of life. Each of 21 questions about how much HF impacts daily activities is scored from 0-no impact to 5-very much (overall score can range from 0 to 105). Improvement is indicated by a decrease in score."|baseline to 12 months|Population is intent to treat.||participants|||Number
729710|NCT00382863|Secondary|Responder Analysis - Six (6) Minute Walk (6MW) Distance|"A participant was considered a responder if 6MW distance at 12 months was at least 45 meters more than at baseline."|baseline to 12 Months|Population is intent to treat||participants|||Number
729711|NCT00382863|Secondary|Responder Analysis - Peak Oxygen Uptake (Peak VO2)|"A participant was considered a responder if cardiopulmonary exercise testing demonstrated an improvement in peak VO2 of at least 1.0 ml/kg/min at 12 months as compared to baseline."|baseline to 12 months|Population is intent to treat.||participants|||Number
729712|NCT00382863|Secondary|Change in Left Ventricular Mass|The difference between each participant's baseline and 6-month echocardiographic measure of left ventricular mass was calculated. The median change for each treatment arm is presented. A decrease in mass is associated with an improvement in the participant's structural heart failure.|baseline to 6 months|Population is intent to treat.||grams||Full Range|Median
729713|NCT00382863|Secondary|Change in Quality of Life as Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)|The KCCQ is a 23-item questionnaire that quantifies physical function, symptoms, social function, self-efficacy/knowledge and quality of life. Scores range from 0 to 100, where higher scores reflect better health status. For this outcome measure, the difference between each participant's baseline and 6-month KCCQ scores was calculated. The mean change for each treatment arm is presented.|baseline to 6 months|Population is intent to treat||score on a scale||Standard Deviation|Mean
729714|NCT00382863|Secondary|Change in New York Heart Association (NYHA) Functional Class|"Change in NYHA functional class between baseline and 6 months. Maintained means the participant's functional class remained the same as baseline. Improved means the participant's functional class improved (became lower in number) by at least one class. Worsened means the participant's functional class deteriorated (became higher in number) by at least one class."|baseline to 6 months|Population is intent to treat.||participants|||Number
729715|NCT00382863|Primary|Number of Participant Deaths|Total number of participants who died within 12 months of enrollment into the trial.|12 months|The population is intent to treat.||participants|||Number
729716|NCT00382863|Primary|Responder Analysis - Minnesota Living With Heart Failure (MLWHF) Quality of Life Overall Score|"A participant was considered a responder if the MLHF overall score had improved by at least 7 points at 6 months as compared to baseline. THE MLHF questionnaire evaluates the impact of heart failure (HF) on a subject's physical, emotional, social and mental aspects of quality of life. Each of 21 questions about how much HF impacts daily activities is scored from 0-no impact to 5-very much (overall score can range from 0 to 105). Improvement is indicated by a decrease in score."|baseline to 6 months|The population is intent to treat.||participants|||Number
729717|NCT00382863|Primary|Responder Analysis - Six (6) Minute Walk (6MW) Distance|"A participant was considered a responder if 6MW distance at 6 months was at least 45 meters more than at baseline."|Baseline to 6 months|The population is intent to treat.||participants|||Number
729718|NCT00382863|Primary|Responder Analysis - Peak Oxygen Uptake (Peak VO2)|"A participant was considered a responder if cardiopulmonary exercise testing demonstrated an improvement in peak VO2 of at least 1.0 ml/kg/min at 6 months as compared to baseline."|Baseline to 6 months|The population is intent to treat.||participants|||Number
729736|NCT00382993|Secondary|Migraine-Associated Sinus Pain Assessed at Baseline, 2, 4, and 8 Hours Post-dose|Number of participants who had sinus pain at the time of assessment.|Baseline, 2, 4, and 8 hours post-dose|ITT Population - included subjects in the Safety Population who provided an evaluation of their study drug for at least one treated attack.||Participants|||Number
729737|NCT00382993|Secondary|Sustained Freedom From Migraine-Associated Sinus Pain|Sustained Freedom from Migraine-Associated Sinus Pain was defined as the absence of sinus pain from 2 to 24 hours post-dose.|2 - 24 hours post-dose|||Participants|||Number
729719|NCT00382928|Secondary|Cerebral Performance at Discharge|"Cerebral Performance Categories/CPC scale:
CPC 1: Good cerebral performance – conscious, alert, able to work, might have mild neurologic or psychological deficit.
CPC 2: Moderate cerebral disability – conscious, sufficient cerebral function for independent activities of daily life. Able to work in sheltered environment.
CPC 3: Severe cerebral disability – conscious, dependent on others for daily support because of impaired brain function. Ranges from ambulatory state to severe dementia or paralysis.
CPC 4: Coma or vegetative state – any degree of coma without the presence of all brain death criteria. Unawareness, even if appears awake (vegetative state) without interaction with environment; may have spontaneous eye opening and sleep/awake cycles. Cerebral unresponsiveness.
CPC 5: Brain death – apnea, areflexia, electroencephalogram (EEG) silence, etc."|At discharge|Only 1 patient in the Intervention group had defibrillation during hospital admission and his CPC was 1.||units on a scale: CPC 1|||Number
729720|NCT00382928|Secondary|Survival to Discharge||At discharge|||participants|||Number
729721|NCT00382928|Secondary|Frequency of Abnormal Rhythms Monitored by the AECD||During the duration of hospital admission on the telemetry ward.|Only the AECD+Standard of Care Group was monitored in this portion of the study.||participants|||Number
729722|NCT00382928|Primary|Number of Participants Without Defibrillation|Time to defibrillation: interval between onset of VT/VF and delivery of first shock. Expected time to defibrillation for AECD group: 30±30 seconds; expected time to defibrillation for Standard of Care group: 180±180.|10 minutes|"There was only one patient in the Intervention group who received defibrillation.
No patients had CPR or defibrillation in the standard of care group."||participants|||Number
729723|NCT00382967|Secondary|Changes That the Doctor Made in the Clinical Management of Subjects Based Upon the Impact of the Imaging Product.|The impact the Datscan image had on the Doctor's decisions on the clinical management of subjects. A record of the number of changes in the Doctor's clinical management. From the first patient visit (baseline) to the fourth patient visit, which was 12 months. This was a 1 year time period being assessed.It is possible for a subject to have multiple changes in Clinical management and other subjects to have no change in their management.|From the first patient Visit 1 (1 month) to Visit 4 (12 months). This goes from the baseline (visit 1) up to 1 year post contrast administration.|The numbers represent the number of changes in decisions that the Doctor made in the clinical management of the patient with Clinically Uncertain Parkinsonism||Number of changes in clinical management|||Number
729724|NCT00382967|Primary|Changes That the Doctor Made in the Clinical Management of Subjects Based Upon the Impact of the Imaging Product.|The impact the Datscan image had on the Doctor's decisions on the clinical management of subjects. A record of the number of changes in the Doctor's clinical management. It is possible for a subject to have multiple changes in Clinical management and other subjects to have no change in their management.|Changes in clinical management made from Visit 1 (baseline) to Visit 3 (a 3 month period)|||Number of changes in clinical management|||Number
729725|NCT00382993|Secondary|Recurrence of Any Migraine Headache Pain|Recurrence is defined as the return of any migraine headache pain during the specified post-dose period, following a pain-free response at 2 hours.|24 hours and 48 hours|Subpopulation of the Intent-to-Treat population of subjects who were pain-free at 2 hours post-dose.||Participants|||Number
729726|NCT00382993|Secondary|Complete Pain/Symptom-Free Assessed at Baseline, 2, 4, and 8 Hours Post-dose|Number of participants who were completely symptom-free (migraine-free plus neck and sinus pain-free) at time of assessment. “Complete pain/symptom-free” was defined as migraine-free, neck pain-free, and sinus pain free.|Baseline, 2, 4, and 8 hours post-dose|ITT Population - included subjects in the Safety Population who provided an evaluation of their study drug for at least one treated attack.||Participants|||Number
729727|NCT00382993|Secondary|Sustained Complete Pain/Symptom-Free|Sustained Complete Pain/Symptom-Free was defined as completely symptom-free (migraine-free plus neck and sinus pain-free) at 2 hours and sustained from 2 to 24 hours without the use of rescue medication.|2 - 24 hours post-dose|||Participants|||Number
729728|NCT00382993|Secondary|Migraine-Associated Nausea Assessed at Baseline, 2, 4, and 8 Hours Post-dose|Number of participants who had nausea at the time of assessment. Resolution of an associated symptom was defined as a migraine headache symptom that was present at the time of treatment that was not present post-dose. Symptom resolution was defined only among subjects who treated while their symptom was present.|Baseline, 2, 4, and 8 hours|ITT Population - included subjects in the Safety Population who provided an evaluation of their study drug for at least one treated attack.||Participants|||Number
729729|NCT00382993|Secondary|Sustained Freedom From Migraine-Associated Nausea|Sustained Freedom from Migraine-Associated Nausea was defined as the absence of nausea from 2 to 24 hours post-dose.|2 - 24 hours post-dose|||Participants|||Number
729730|NCT00382993|Secondary|Migraine-Associated Phonophobia Assessed at Baseline, 2, 4, and 8 Hours Post-dose|Number of participants who had phonophobia (sensitivity to noise) at the time of assessment.|Baseline, 2, 4, and 8 hours post-dose|ITT Population - included subjects in the Safety Population who provided an evaluation of their study drug for at least one treated attack.||Participants|||Number
729731|NCT00382993|Secondary|Sustained Freedom From Migraine-Associated Phonophobia|Sustained Freedom from Migraine-Associated Phonophobia was defined as the absence of phonophobia (sensitivity to noise) from 2 to 24 hours post-dose.|2 - 24 hours post-dose|||Participants|||Number
729732|NCT00382993|Secondary|Migraine-Associated Photophobia Assessed at Baseline, 2, 4, and 8 Hours Post-dose|Number of participants who had photophobia (sensitivity to light) at the time of assessment.|Baseline, 2, 4, and 8 hours post-dose|ITT Population - included subjects in the Safety Population who provided an evaluation of their study drug for at least one treated attack.||Participants|||Number
729733|NCT00382993|Secondary|Sustained Freedom From Migraine-Associated Photophobia|Sustained Freedom from Migraine-Associated Photophobia was defined as the absence of photophobia (sensitivity to light) from 2 to 24 hours post-dose.|2 - 24 hours post-dose|||Participants|||Number
729734|NCT00382993|Secondary|Migraine-Associated Neck Pain Assessed at Baseline, 2, 4, and 8 Hours Post-dose|Number of Participants with neck pain at the time of assessment.|Baseline, 2, 4, and 8 hours post-dose|ITT Population - included subjects in the Safety Population who provided an evaluation of their study drug for at least one treated attack.||Participants|||Number
729735|NCT00382993|Secondary|Sustained Freedom From Migraine-Associated Neck Pain|Sustained Freedom from Migraine-Associated Neck Pain was defined as the absence of neck pain from 2 to 24 hours post-dose.|2 - 24 hours post-dose|||Participants|||Number
729738|NCT00382993|Secondary|Migraine-Free Assessment at 2, 4, and 8 Hours Post-dose|Migraine-free was defined as pain-free with no traditional migraine-associated symptoms (i.e.,photophobia, phonophobia, nausea and vomiting) at the time of the assessment.|2, 4 , and 8 hours post-dose|ITT Population - included subjects in the Safety Population who provided an evaluation of their study drug for at least one treated attack.||Participants|||Number
729739|NCT00382993|Secondary|Sustained Freedom From Migraine|Migraine-free was defined as pain-free with no traditional migraine-associated symptoms (i.e.,photophobia, phonophobia, nausea). Sustained migraine-free was defined as migraine-free at 2 hours and sustained from 2 to 24 hours post dose without the use of rescue medication.|2 - 24 hours post-dose|||Participants|||Number
729740|NCT00382993|Secondary|Migraine Headache Pain Free at 0.5, 1, 4, and 8 Hours Post-Dose|Participants rated their pain severity using a four point scale where 0=no pain, 1=mild pain, 2=moderate pain, and 3=severe pain. Pain-free was a rating of 0 (no pain) at the specified time.|0.5, 1, 4, and 8 Hours Post-Dose|ITT Population - included subjects in the Safety Population who provided an evaluation of their study drug for at least one treated attack.||Participants|||Number
729741|NCT00382993|Secondary|Rescue Medication Use During 0 - 24 Hours Post-Dose|A rescue medication was defined as an additional medication taken for the treatment of migraine headache pain symptoms associated with the attack. Allowed were a single dose of either: sumatriptan (50mg or 100mg), OR naproxen sodium (max 550mg), OR, an over-the-counter pain-reliever (per label).|0-24 Hours Post-Dose|ITT Population - included subjects in the Safety Population who provided an evaluation of their study drug for at least one treated attack.||Participants|||Number
729742|NCT00382993|Secondary|Migraine Headache Pain Free at 2 Hours Post-Dose|Participants rated their pain severity using a four point scale where 0=no pain, 1=mild pain, 2=moderate pain, and 3=severe pain. Pain-free was a rating of 0 (no pain) at the specified time.|2 Hours Post-Dose|ITT Population - included subjects in the Safety Population who provided an evaluation of their study drug for at least one treated attack.||Participants|||Number
729743|NCT00382993|Primary|Sustained Freedom From Migraine Pain Between 2-24 Hours Post-dose|Sustained freedom from migraine pain was defined as having no pain at 2 hours post-dose without the use of rescue medication; and without the recurrence of any pain or the use of any rescue medication 2 to 24 hours post-dose.|2 - 24 Hours Post-Dose|ITT (Intent-to-Treat) Population - included subjects in the Safety Population who provided an evaluation of their study drug for at least one treated attack.||Participants|||Number
729744|NCT00383019|Secondary|Number of Subjects With an IOP Reduction of >=3 mmHg From Baseline to Week 8|Number of subjects whose IOP were reduced by 3 mmHg or more at Week 8 from baseline|Baseline to Week 8|The efficacy analysis population was ITT. If there were any missing IOP values at Week 8, the data were supplemented by LOCF using data at Week 4.||participants|||Number
729745|NCT00383019|Secondary|Number of Subjects With an IOP Reduction of >=2 mmHg From Baseline to Week 8|Number of subjects whose IOP were reduced by 2 mmHg or more at Week 8 from baseline|Baseline to Week 8|The efficacy analysis population was ITT. If there were any missing IOP values at Week 8, the data were supplemented by LOCF using data at Week 4.||participants|||Number
729746|NCT00383019|Secondary|Number of Subjects With an IOP of <=18 mmHg at Week 8|Number of subjects who achieved IOP reduction to 18 mmHg or below at Week 8|Week 8|The efficacy analysis population was ITT. If there were any missing IOP values at Week 8, the data were supplemented by LOCF using data at Week 4.||participants|||Number
729747|NCT00383019|Secondary|Number of Subjects With an IOP of <=17 mmHg at Week 8|Number of subjects who achieved IOP reduction to 17 mmHg or below at Week 8|Week 8|The efficacy analysis population was ITT. If there were any missing IOP values at Week 8, the data were supplemented by LOCF using data at Week 4.||participants|||Number
729748|NCT00383019|Secondary|Number of Subjects With an IOP of <=16 mmHg at Week 8|Number of subjects who achieved IOP reduction to 16 mmHg or below at Week 8|Week 8|The efficacy analysis population was ITT. If there were any missing IOP values at Week 8, the data were supplemented by LOCF using data at Week 4.||participants|||Number
729749|NCT00383019|Secondary|Number of Subjects With an IOP of <=15 mmHg at Week 8|Number of subjects who achieved IOP reduction to 15 mmHg or below at Week 8|Week 8|The efficacy analysis population was ITT. If there were any missing IOP values at Week 8, the data were supplemented by LOCF using data at Week 4.||participants|||Number
729750|NCT00383019|Secondary|Percent Change of IOP From Baseline to Week 8|Value at Week 8 minus value at baseline was divided by baseline value, then multiplied by 100|Baseline to Week 8|The efficacy analysis population was ITT. If there were any missing IOP values at Week 8, the data were supplemented by LOCF using data at Week 4.||percent change||95% Confidence Interval|Least Squares Mean
729751|NCT00383019|Secondary|Change of IOP From Baseline to Week 4|Value at Week 4 minus value at baseline|Baseline to Week 4|ITT||mmHg||95% Confidence Interval|Least Squares Mean
729752|NCT00383019|Primary|Change of Intraocular Pressure (IOP) From Baseline to Week 8|Value at Week 8 minus value at baseline|Baseline to Week 8|The primary efficacy analysis population was the Intent-to-treat population (ITT) which consisted of all subjects treated with the study drug as randomized. If there were any missing IOP values at Week 8, the data were supplemented by LOCF (Last Observation Carried Forward) using data at Week 4.||mmHg||95% Confidence Interval|Least Squares Mean
729753|NCT00383071|Primary|Safety of H5N1 Vaccine as Measured by Adverse Events|The number of subjects experiencing adverse events after receiving H5N1 vaccine|Day 28, 56, 84|Primary outcome measure was safety, so below listed numbers are safety population used in AE list.||participants|||Number
729754|NCT00383084|Secondary|Functional Capacity (Higher Scores Indicative of Poorer Functioning)|Fibromyalgia Impact Questionnaire (a higher total score indicates poorer functioning). The range of possible scores is 0 to 100|Baseline and after 12-weeks|||units on a scale||Standard Deviation|Mean
729755|NCT00383084|Secondary|Number of Tender Points on the Body|Number of tender points on physical examination (maximum number is 18)|Baseline and after 12-weeks|||tender points||Standard Deviation|Mean
729756|NCT00383084|Primary|Ambulatory Fatigue, Higher Values Indicate Greater Fatigue|0-100 fatigue ratings, higher scores indicative of greater levels of fatigue|Baseline and after 12-weeks|||units on a scale||Standard Deviation|Mean
729757|NCT00383084|Primary|Ambulatory Pain (Higher Values Indicate Greater Pain)|0 to 100 pain rating, higher numbers indicate greater pain|Baseline and after 12-weeks|||units on a scale||Standard Deviation|Mean
729761|NCT00383110|Primary|Health Care System Distrust Scale|Health Care System Distrust Scale is a valid and reliable 10-item measure of distrust of the health care system, measuring honesty confidentiality and confidence. All questions are measured on a Likert scale, with scores ranging from a minimum of 10 to a maximum of 50. Higher scores indicate more distrust in the health care system.|12 months after enrollment|Discrepancies in number of participants analyzed is due to some participants choosing not to answer all questions.||units on a scale||Standard Deviation|Mean
729762|NCT00383110|Secondary|Hemoglobin A1c||12 months after enrollment|Discrepancies in number of participants analyzed is due to some participants having no data in their medical record for this measure.||% HbA1c||Standard Deviation|Mean
729763|NCT00383110|Primary|General Trust in Physicians Scale (GTIPS)|The GTIPS is a valid and reliable 11-item measure of general trust in physicians in the domains of dependability, confidence, and confidentiality of information. All items are fashioned in a 5-point Likert format with a minimum score of 11 and maximum of 55. Higher scores indicate more trust in physicians.|12 months following enrollment|Discrepancies in number of participants analyzed is due to some participants choosing not to answer all questions.||units on a scale||Standard Deviation|Mean
729764|NCT00383123|Secondary|Number of Subjects Reporting New Onset Chronic Illnesses and/or Serious Adverse Events (SAE)|"SAE: any untoward medical occurrence that
resulted in death,
was life-threatening,
required hospitalization or prolongation of existing hospitalization,
resulted in disability/incapacity, or
was a congenital anomaly/birth defect in the offspring of a study subject.
Examples of possible new onset chronic illnesses include but are not limited to diabetes, asthma, allergies, autoimmune disease, cancer, neuropathic disorders."|Up to 6 months after vaccination|||subjects|||Number
729765|NCT00383123|Secondary|Number of Subjects Reporting Unsolicited Adverse Events|"An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Any = at least one symptom irrespective of intensity and relationship to vaccination; Grade 3 = preventing normal activity; Related = considered by the investigator to be causally related to the study vaccination."|Within 28 days following vaccination|||subjects|||Number
729766|NCT00383123|Secondary|Number of Subjects Reporting Solicited Local and General Symptoms|"Solicited local symptoms assessed include pain, redness, and swelling. Solicited general symptoms assessed include drowsiness, fever, irritability, loss of appetite, arthralgia, fatigue, headache, muscle aches, and shivering.
Data across doses are presented. Any = at least one symptom irrespective of intensity/relationship to vaccination; Grade 3: symptom that prevented normal everyday activities; Related: considered by the investigator as related to the study vaccination."|During a 4-day follow-up period after each vaccination|"Analysis was performed on vaccinated subjects with available data.
Pain, redness, swelling and fever were assessed in all age cohorts.
Drowsiness, irritability and loss of appetite were assessed in the 6 months to < 5 years cohort only.
Arthralgia, fatigue, headache, muscle aches and shivering were assessed in the 5 to < 18 years cohort only."||subjects|||Number
729767|NCT00383123|Secondary|Number of Initially Unprotected Subjects With at Least a 4 Fold Increase in HI Titer|Initially unprotected subjects are subjects with a baseline HI titer < 1:40. Data are presented for all 3 viral strains comprised in the vaccine.|21 or 28 days after last vaccine dose|As per protocol, only subjects from the ATP cohort for immunogenicity aged 6 months to < 5 years and with a baseline titre < 1:40 were analysed for this Outcome Measure.||subjects|||Number
729768|NCT00383123|Secondary|Number of Seroprotected Subjects|Seroprotected subjects are defined as vaccinees with a serum HI titer ≥ 1:40. Data are presented for all 3 viral strains comprised in the vaccine.|Before (PRE) and 21 or 28 days after (POST) the last vaccine dose|As per protocol, seroprotection was assessed in part of the ATP cohort for immunogenicity: children aged 6 months to < 5 years for whom results were available.||subjects|||Number
729769|NCT00383123|Primary|Number of Subjects Reporting Rare Serious Events|"Rare serious event is defined as any untoward medical event with an occurrence rate of ≥1/300 that:
resulted in death,
was life-threatening,
required hospitalization or prolongation of existing hospitalization,
resulted in disability/incapacity, or
was a congenital anomaly/birth defect in the offspring of a study subject."|Up to 6 months after vaccination|||subjects|||Number
729770|NCT00383123|Primary|Number of Seroconverted Subjects|"Seroconverted subjects are defined as subjects with either a pre-vaccination HI titer <1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum 4-fold increase at post-vaccination titer.
Data are presented for all 3 viral strains comprised in the vaccine."|21 or 28 days after last vaccine dose|As per protocol, seroconversion was assessed in part of the ATP cohort for immunogenicity: children aged 6 months to < 5 years for whom post-vaccination results were available.||subjects|||Number
729771|NCT00383123|Primary|Geometric Mean Titer (GMT) of Serum Haemagglutination-inhibition (HI) Antibodies|GMTs and their 95% confidence interval are presented for all 3 viral strains comprised in the vaccine.|21 or 28 days after last vaccine dose|Per protocol, GMTs were assessed only in part of the According-To-Protocol (ATP) cohort for immunogenicity (children aged 6 months to < 5 years).||Titer||95% Confidence Interval|Geometric Mean
729772|NCT00383149|Secondary|Change From Baseline in FHSI-8 Total Score by Time-point|The FHSI-8 includes eight items representing pancreatic-related symptoms; each symptom is rated by participants on a scale of from 0 to 4. The FHSI-8 total score ranges in value from 0 to 32, with higher scores representing fewer symptoms and lower scores representing more symptoms. Scoring of the FHSI-8 was to be conducted according to the Functional Assessment of Chronic Illness Therapy (FACIT) manual. The symptom assessment was to include treated participants who had baseline measurement and at least one on-study measurement of FHSI-8 questionnaire.|Baseline, Week 3, Week 6, Week 9, Week 12, Week 12, Week 18, Week 24 and every 3 weeks through end of study (participant death/withdrawal from study)|Since the combination of ixabepilone and cetuximab tested in this trial failed to meet the primary objective of sufficiently improving 6-month survival rate relative to historical control in participants with metastatic pancreatic cancer, FHSI-8 score data were collected but not summarized.|||||
729773|NCT00383149|Secondary|Percentage of Participants With Baseline Epidermal Growth Factor Receptor (EGFR) Tumor Expression|EGFR expression was evaluated by means of an immunohistochemical assay using tumor tissue collected prior to receiving first dose.|Baseline|Tissue was available for a small proportion of patients and only 1 out of 11 was EGFR positive, hence EFGR expression analysis was not performed.|||||
729774|NCT00383149|Secondary|Number of Participants With Dose Reduction, Dose Delay, or Dose Interruption|Dose reduction of ixabepilone and/or cetuximab due to toxicity was permitted for participants deriving benefit from therapy. Each drug could be dose modified independently of the others. Participants unable to start a cycle due to unacceptable toxicity related to ixabepilone or cetuximab could have therapy delayed for up to 4 weeks. If toxicities prevented the administration of ixabepilone or cetuximab therapy, participants continued receiving the other therapy as scheduled. A dose interruption for ixabepilone or cetuximab was defined as any interruption during the infusion period.|From the first dosing date of Cycle 1 until the last dosing date of the last cycle. Last dosing cycle for a participant was Cycle 21.|Since the combination of ixabepilone and cetuximab tested in this trial failed to meet the primary objective of sufficiently improving 6-month survival rate relative to historical control in participants with metastatic pancreatic cancer, dose modification data were collected but not summarized.|||||
729775|NCT00383149|Secondary|Number of Participants With Hematology, Liver Function, and Renal Laboratory Abnormalities By CTC v3 Grade (Gr)|Laboratory results were graded according to CTC v 3.0. Hematology laboratory evaluations included absolute neutrophil count (ANC), white blood cell count (WBC), platelets (PLT), and hemoglobin (HGB). Liver function laboratory evaluations included alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, and total bilirubin. Renal function laboratory evaluation included creatinine.|From the time of first dose of study drug to ≤30 days after the end of the last dose of study drug or until resolution of study drug-related toxicity.|Treated participants; all participants who received at least one dose of ixabepilone or cetuximab. n= number of participants with laboratory data available||participants|||Number
729776|NCT00383149|Secondary|Number of Participants With Most Common Treatment-related Nonhematologic AE (>25%) By CTC v3 Grade (Gr)|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition not necessarily having a causal relationship with this treatment. Acneform rash and peripheral neuropathy were captured by multiple MedDRA preferred terms. Acneform rash included rash, rash pustular, and rash pruritic preferred terms. Peripheral neuropathy included neuromuscular toxicity, peripheral motor neuropathy, and peripheral sensorimotor neuropathy preferred terms.|From the time of first dose of study drug to ≤30 days after the end of the last dose of study drug or until resolution of study drug-related toxicity.|Treated participants; all participants who received at least one dose of ixabepilone or cetuximab.||participants|||Number
729777|NCT00383149|Secondary|Number of Participants With Death Within 30 Days of Last Dose, Any Serious Adverse Event (SAE), Any Adverse Event (AE) Leading to Discontinuation (DC), or Any Treatment-related AEs By Common Terminology Criteria Version 3.0 (CTC v3) Grade (Gr)|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition not necessarily having a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization/causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, or is an important medical event.|From the time of first dose of study drug to ≤30 days after the end of the last dose of study drug or until resolution of study drug-related toxicity.|Treated participants; all participants who received at least one dose of ixabepilone or cetuximab. The 53 participants reporting treatment-related AEs included 1 additional participant who also developed Grade 5 viscous intestinal perforation, which was also captured under death within 30 days of last dose category.||participants|||Number
729778|NCT00383149|Secondary|Median Time to Response|Time to response was defined as the number of weeks from first dose of study therapy (ixabepilone or cetuximab) until measurement criteria were first met for PR or CR, whichever status was recorded first. Complete Response (CR)= disappearance of all non-target lesions, Partial Response (PR)= at least 30% reduction in the sum of the longest diameter (LD) of all target lesions in reference to the baseline sum LD.|Time from first dose of study therapy until first date of PR or CR. Maximum time to response was 19 months.|Response-evaluable participants whose best response was PR or CR.||weeks||Full Range|Median
729779|NCT00383149|Secondary|Median Duration of Response|Duration of response was defined as the number of months from when measurement criteria were first met for CR or PR (whichever was recorded first) until the first date of disease progression or death. Complete Response (CR)= disappearance of all non-target lesions, Partial Response (PR)= at least 30% reduction in the sum of the longest diameter (LD) of all target lesions in reference to the baseline sum LD.|From first date recorded for CR or PR until the first date of disease progression or death (last participant with tumor response progressed 6.5 months after documented response).|Response-evaluable participants whose best response was PR or CR. Participants without disease progression or death were censored at the last tumor assessment date.||months||95% Confidence Interval|Median
729780|NCT00383149|Secondary|Median Overall Survival Time|Overall survival time was defined as the time in months from the first dosing date to the date of death.|From the first dosing date until death (last reported death was 21 months after first dose).|Treated participants; all participants who received at least one dose of ixabepilone or cetuximab. Participants without a reported date of death were censored at the last known alive date.||months||95% Confidence Interval|Median
729781|NCT00383149|Secondary|Median Progression Free Survival Time|Progression-Free Survival (PFS) time was defined as the time, in months, from the first dosing date until the date of disease progression or death from any cause.|From time of first dose of study until 16.49 months (longest period for participant between first dose and documented disease progression|Treated participants; all participants who received at least one dose of ixabepilone or cetuximab. Participants without disease progression or death were censored at the last tumor assessment.||months||95% Confidence Interval|Median
729782|NCT00383149|Secondary|Percentage of Participants With Objective Tumor Response|Percentage of participants with objective tumor response was determined by the number of participants with PR or CR divided by the total number of response-evaluable participants. Tumor response was assessed according RECIST criteria: PR=at least 30% reduction in the sum of the LD of all target lesions in reference to the baseline sum LD, CR=Disappearance of all non-target lesions.|From time of first dose of study until 16.49 months (longest period for participant between first dose and documented disease progression|Response-evaluable participants; all participants with measurable disease who received at least one dose of ixabepilone or cetuximab and who had at least one on-treatment tumor assessment.||percentage of participants||95% Confidence Interval|Number
729783|NCT00383149|Secondary|Best Overall Tumor Response|Tumor response was assessed according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)= disappearance of all non-target lesions, Partial Response (PR)= at least 30% reduction in the sum of the longest diameter (LD) of all target lesions in reference to the baseline sum LD; Stable Disease (SD)= neither PR nor progressive disease (PD) criteria were met; PD = at least 20% increase in the sum of the LD of all target lesions, taking as reference the smallest sum LD recorded at or following baseline.|From time of first dose of study until 16.49 months (longest period for participant between first dose and documented disease progression)|Response-evaluable participants; all participants with measurable disease who received at least one dose of ixabepilone or cetuximab and who had at least one on-treatment tumor assessment.||participants|||Number
729784|NCT00383149|Primary|Percentage of Participants Surviving at 6 Months|The percentage of participants surviving at 6 months was defined as the number of treated participants who had not died prior to 6 months from the date of their first dose divided by the total number of treated participants.|From time of first dose of study drug through 6 months|Treated participants; all participants who received at least one dose of ixabepilone or cetuximab. Participants who did not die prior to 6 months but dropped out of the study were not included in the numerator.||percentage of participants||95% Confidence Interval|Number
729785|NCT00383162|Secondary|Recurrence of Any Migraine Headache Pain|Recurrence is defined as the return of any migraine headache pain during the specified post-dose period, following a pain-free response at 2 hours.|24 hours and 48 hours|Subpopulation of the Intent-to-Treat population of subjects who were pain-free at 2 hours post-dose. Placebo-23 subjects and Sumatriptan/Naproxen Sodium 54 subjects||Participants|||Number
729786|NCT00383162|Secondary|Complete Pain/Symptom-Free Assessed at Baseline, 2, 4, and 8 Hours Post-dose|Number of participants who were completely symptom-free (migraine-free plus neck and sinus pain-free) at time of assessment.“Complete pain/symptom-free” was defined as migraine-free, neck pain-free, and sinus pain free.|Baseline, 2, 4, and 8 hours post-dose|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.||Participants|||Number
729787|NCT00383162|Secondary|Sustained Complete Pain/Symptom-Free|Sustained Complete Pain/Symptom-Free was defined as completely symptom-free (migraine-free plus neck and sinus pain-free) at 2 hours and sustained from 2 to 24 hours without the use of rescue medication.|2 - 24 hours post-dose|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.||Participants|||Number
729788|NCT00383162|Secondary|Migraine-Associated Nausea Assessed at Baseline, 2, 4, and 8 Hours Post-dose|Number of participants who had nausea at the time of assessment. Resolution of an associated symptom was defined as a migraine headache symptom that was present at the time of treatment that was not present post-dose. Symptom resolution was defined only among subjects who treated while their symptom was present.|Baseline, 2, 4, and 8 hours|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.||Participants|||Number
729789|NCT00383162|Secondary|Sustained Freedom From Migraine-Associated Nausea|Sustained Freedom from Migraine-Associated Nausea was defined as the absence of nausea from 2 to 24 hours post-dose.|2 - 24 hours post-dose|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.||Participants|||Number
729790|NCT00383162|Secondary|Migraine-Associated Phonophobia Assessed at Baseline, 2, 4, and 8 Hours Post-dose|Number of participants who had phonophobia (sensitivity to noise) at the time of assessment.|Baseline, 2, 4, and 8 hours post-dose|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.||Participants|||Number
729791|NCT00383162|Secondary|Sustained Freedom From Migraine-Associated Phonophobia|Sustained Freedom from Migraine-Associated Phonophobia was defined as the absence of phonophobia (sensitivity to noise) from 2 to 24 hours post-dose.|2 - 24 hours post-dose|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.||Participants|||Number
729792|NCT00383162|Secondary|Migraine-Associated Photophobia Assessed at Baseline, 2, 4, and 8 Hours Post-dose|Number of participants who had photophobia (sensitivity to light) at the time of assessment.|Baseline, 2, 4, and 8 hours post-dose|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.||Participants|||Number
729793|NCT00383162|Secondary|Sustained Freedom From Migraine-Associated Photophobia|Sustained Freedom from Migraine-Associated Photophobia was defined as the absence of photophobia (sensitivity to light) from 2 to 24 hours post-dose.|2 - 24 hours post-dose|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.||Participants|||Number
729794|NCT00383162|Secondary|Migraine-Associated Neck Pain Assessed at Baseline, 2, 4, and 8 Hours Post-dose|Number of Participants with neck pain at the time of assessment.|Baseline, 2, 4, and 8 hours post-dose|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.||Participants|||Number
729795|NCT00383162|Secondary|Sustained Freedom From Migraine-Associated Neck Pain|Sustained Freedom from Migraine-Associated Neck Pain was defined as the absence of neck pain from 2 to 24 hours post-dose.|2 - 24 hours post-dose|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.||Participants|||Number
729796|NCT00383162|Secondary|Migraine-Associated Sinus Pain Assessed at Baseline, 2, 4, and 8 Hours Post-dose|Number of participants who had sinus pain at the time of assessment.|Baseline, 2, 4, and 8 hours post-dose|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.||Participants|||Number
729797|NCT00383162|Secondary|Sustained Freedom From Migraine-Associated Sinus Pain|Sustained Freedom from Migraine-Associated Sinus Pain was defined as the absence of sinus pain from 2 to 24 hours post-dose.|2 - 24 hours post-dose|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.||Participants|||Number
729798|NCT00383162|Secondary|Migraine-Free Assessment at 2, 4, and 8 Hours Post-dose|Migraine-free was defined as pain-free with no traditional migraine-associated symptoms (i.e.,photophobia, phonophobia, nausea and vomiting) at the time of the assessment.|2, 4 , and 8 hours post-dose|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.||Participants|||Number
729799|NCT00383162|Secondary|Sustained Freedom From Migraine|Migraine-free was defined as pain-free with no traditional migraine-associated symptoms (i.e.,photophobia, phonophobia, nausea). Sustained migraine-free was defined as migraine-free at 2 hours and sustained from 2 to 24 hours post dose without the use of rescue medication.|2 - 24 hours post-dose|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.||Participants|||Number
729800|NCT00383162|Secondary|Pain-Free Assessment at 1/2, 1, 4, 8 Hours Post-dose|Participants rated their pain severity using a four point scale where 0=no pain, 1=mild pain, 2=moderate pain, and 3=severe pain. Pain-free was a rating of 0 (no pain) at the specified time.|1/2, 1, 4, and 8 hours post-dose|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.||Participants|||Number
729801|NCT00383162|Secondary|Rescue Medication Used up to 24 Hours Post-dose|A rescue medication was defined as an additional medication taken for the treatment of migraine headache pain symptoms associated with the attack. Allowed were a single dose of either: sumatriptan (50mg or 100mg), OR naproxen sodium (max 550mg), OR, an over-the-counter pain-reliever (per label).|Dosing to 24 hours post-dose|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.||Participants|||Number
729802|NCT00383162|Secondary|Pain-Free Assessment at 2 Hours Post-dose|Participants rated their pain severity using a four point scale where 0=no pain, 1=mild pain, 2=moderate pain, and 3=severe pain. Pain-free was a rating of 0 (no pain) at the specified time.|2 hours post-dose|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.||Participants|||Number
729803|NCT00383162|Primary|Sustained Freedom From Migraine Pain Between 2-24 Hours Post-dose|Sustained freedom from migraine pain was defined as having no pain at 2 hours post-dose without the use of rescue medication; and without the recurrence of any pain or the use of any rescue medication 2 to 24 hours post-dose.|2 - 24 hours post-dose|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.||Participants|||Number
729804|NCT00383240|Other Pre-specified|Number of Participants With at Least One Severe Asthma Exacerbation|"A severe asthma exacerbation was defined as a clinically judged deterioration of asthma or a meaningful reduction in lung function based on any of the following criteria during the Treatment Period:
A decrease in FEV1 below the Treatment Period stability limit at any visit,
A decrease in AM or PM peak flow below the Treatment Period stability limits on any 2 consecutive days,
An occurrence of any clinical deterioration of asthma (ie, asthma attack) that resulted in emergency treatment, hospitalization due to asthma, or treatment with additional, excluded asthma medication."|Baseline to Week 26|All Randomized Subjects||participants|||Number
729805|NCT00383240|Secondary|Change From Baseline in Proportion of Nights Across the Treatment Period With Nocturnal Awakenings Due to Asthma Which Require Use of Short-acting Beta 2-agonist (SABA)|Baseline is the proportion of nights of last week (Days -7 to 1) prior to first dose with nocturnal awakenings. Scale is measured as 0 to 1 with 0=no awakenings to 1=awakenings every night. Standard deviation is pooled.|Baseline to Endpoint|ITT population from the entire 26-week treatment period||Ratio||Standard Deviation|Least Squares Mean
729806|NCT00383240|Secondary|Change From Baseline to Week 26 in the Asthma Control Questionnaire (ACQ) Score|ACQ consists of seven questions each scaled from 0 (best case) to 6 (worst case).|Baseline to week 26|ITT population with non-missing post-baseline ACQ result||units on a scale||Standard Deviation|Least Squares Mean
729807|NCT00383240|Primary|Time-to-first Asthma Exacerbation Over the 26-week Treatment Period for the Comparison of MF/F Versus F|This endpoint was to measure the time it took for 50% of subjects in a treatment arm to experience a severe asthma exacerbation (also see the posted Other Pre-specified Outcome: Number of Participants With at Least One Severe Asthma Exacerbation)|26-week Treatment Period|All Randomized Subjects||days||Inter-Quartile Range|Median
729808|NCT00383240|Secondary|Change From Baseline to Week 26 in Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ[S]) Total Score|AQLQ(S) consists of 32 questions each scaled from 1 (worst case) to 7 (best case). Standard deviations are pooled.|Baseline to Week 26|ITT population with non-missing post-baseline AQLQ result||units on a scale||Standard Deviation|Least Squares Mean
729809|NCT00383240|Primary|Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 12 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) for MF/F Versus MF||Baseline to Endpoint (12 weeks)|Intent to Treat (ITT) population||liters x hours||Standard Deviation|Least Squares Mean
729810|NCT00383266|Secondary|Overall Survival (OS)|OS is defined as the time from initiation of treatment to the date of any reason death while those living subjects will be censored at the last assessment date.|Until patient's death (median follow-up 293 days -- range (63-632 days))|||months||95% Confidence Interval|Median
729811|NCT00383266|Secondary|Overall Survival Rate||2 years|||percentage of participants|||Number
729812|NCT00383266|Secondary|Toxicities||30 days following completion of treatment (maximum number of cycles = 6)|||participants|||Number
729813|NCT00383266|Secondary|Overall Survival Rate||1 year|||percentage of participants|||Number
729814|NCT00383266|Secondary|Time to Disease Progression|-Progressive disease=at least a 20% increase in the sum of the LD of the target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions|Until patient progresses (median follow-up 293 days -- range (63-632 days)|||months||95% Confidence Interval|Median
729815|NCT00383266|Primary|Overall Response Rate (ORR)|"Overall response rate = complete response (CR) + partial response (PR) using RECIST.
CR=disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level
PR=at least a 30% decrease in the sum of the longest diameter (LD) of the target lesions taking as reference the baseline sum LD"|Until patient progresses or dies (median follow-up 293 days -- range (63-632 days)|||percentage of participants|||Number
729821|NCT00383331|Primary|Best Overall Tumor Response|"Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve (respond), stay the same (stable), or worsen (progression) during treatment."|baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up|||participants|||Number
729822|NCT00383435|Secondary|Number of Participants With Mild, Moderate, or Severe COPD Exacerbations|Mild = 12 or more inhalations/day of inhaled rescue medication or 2 or more nebulized treatments/day of inhaled rescue medication. Moderate = treatment with antibiotics or oral steroids. Severe = emergency room treatment or hospitalizations of survival curves. If an event was composed of multiple criteria, the most severe criteria was assigned to the event.|Endpoint (26 weeks)|ITT population||Participants|||Number
729823|NCT00383435|Secondary|Number of Participants With Partly Stable COPD|"Partly stable COPD was a composite measure that included the following COPD
outcomes: (1) No oral steroid rescue medication; (2) No AM or PM COPD weekly average symptom score greater than 2 during at least 7 of 8 weeks; (3) No moderate or severe exacerbations; (4) No unscheduled visits due to COPD worsenings; (5) No study discontinuation due to treatment failure or
treatment-related adverse event as determined by the investigator."|Endpoint (26 weeks)|ITT population||Participants|||Number
729824|NCT00383435|Secondary|Change From Baseline in Proportion of Chronic Obstructive Pulmonary Disease (COPD) Symptom-Free Nights (AM Diary Symptoms)|Prior to the use of study drug rescue medication (in the morning upon awakening) the participant evaluated the COPD symptoms of wheezing, cough, and difficulty breathing. A symptom-free night was defined as a combined score of 0 (no symptoms) across all three COPD symptoms evaluated the following morning. Proportion for Baseline included data from the last week before the first dose. Proportion for Endpoint included data across the entire 26-week treatment period.|Baseline to Endpoint (26 weeks)|ITT population.||Proportion of symptom-free nights||Standard Deviation|Least Squares Mean
729825|NCT00383435|Secondary|Change From Baseline to Endpoint in St George's Respiratory Questionaire (SGRQ) Total Score|SGRQ consisted of 76 items aggregated into 3 component scores: symptoms (frequency/severity), activity (cause or limited by breathlessness), impact (social functioning, psychological disturbances from airway disease), & total score. Best health scores have a low numeric value. All component scores & total score range from 0-100, with a higher score indicating greater disease burden. A 4-point increase over placebo (and Baseline) was considered the minimum clinically important difference. Endpoint is the last post-baseline non-missing result through the 26 week evaluation carried forward.|Baseline to Endpoint (26 weeks)|ITT population||Score on a scale||Standard Deviation|Least Squares Mean
729826|NCT00383435|Primary|Mean Change From Baseline to Week 13 Endpoint in AM Predose FEV1|"Endpoint was the last post-baseline non-missing result through Week 13 carried
forward."|Baseline to Endpoint (13 weeks)|ITT population||Liters||Standard Deviation|Least Squares Mean
729827|NCT00383435|Primary|Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 13 in Forced Expiratory Volume (Liters) in 1 Second (FEV1)|FEV1 AUC was standardized to liters. Endpoint was the last post-baseline non-missing result through Week 13 carried forward.|Baseline to Endpoint (13 weeks)|Intent-to-treat (ITT) population||Liters||Standard Deviation|Least Squares Mean
729828|NCT00383500|Primary|Incidence of Lymphedema (Newly-developing)|Incidence of newly-developing lymphedema for each study cohort, as detected by serial multiple frequency bioimpedance spectroscopy scans for increased interstitial fluid within regional tissues.|3 years of semi-annual follow-up|||participants|||Number
729829|NCT00383500|Primary|Number of Participants With Successful Assessment of Lymphedema by Multiple Frequency Bioimpedance Spectroscopy|Successful, serial multiple frequency bioimpedance assessment for newly developing lymphedema in the 3 study groups|36 months|All enrolled patients in the trial who did not withdraw or were lost to follow-up||participants|||Number
729830|NCT00383552|Primary|Number of Participants With at Least One Severe Asthma Exacerbation at Week 26|Severe asthma exacerbation refers to an occurrence of a decrease below 80% of Baseline in FEV1, a decrease below 70% of Baseline in PEF on 2 consecutive days and or a clinical deterioration of asthma resulting in emergency treatment, hospitalization or treatment with asthma medication.|Week 26|||participants|||Number
729831|NCT00383552|Secondary|AUC(0-12 Hour) of the Change From Baseline to Week 12 in FEV1 for Each Body Mass Index (BMI) Subgroup|The average of the two predose FEV1 measurements (30 minutes prior to dosing and 0 hour, immediately prior to dosing) at the Baseline Visit were subtracted from each of the serial measurements over the 12-hour period. The AUC was calculated based on these changes from Baseline evaluations. BMI is a number calculated from a person's weight and height. The higher the number, the higher the amount of fat. The comparison was for MF/F vs placebo. Standard deviation was pooled.|Baseline to Week 12|Efficacy analyses were based on randomized participants with Baseline and any post-baseline data (intent-to-treat principle).||liters * hours||Standard Deviation|Least Squares Mean
729832|NCT00383552|Secondary|Change From Baseline in AM FEV1 Pre-dose Assessment, or Trough FEV1, at Week 12|Trough FEV1 is a measure of the end-of-dosing interval. The comparison was for MF/F vs F. Standard deviation was pooled.|Baseline to Week 12|Efficacy analyses were based on randomized participants with Baseline and any post-baseline data (intent-to-treat principle).||liters||Standard Deviation|Least Squares Mean
729833|NCT00383552|Secondary|Change From Baseline in Proportion of Nights Across the Treatment Period With Nocturnal Awakenings Due to Asthma Which Require Use of Short-acting Beta Agonists (SABA)|Baseline is the proportion of nights of the last week (Days -7 to 1) prior to first dose with nocturnal awakenings. Scale is measured as 0 to 1 with 0=no awakenings to 1=awakenings every night. The comparison was for MF/F vs placebo. Standard deviation was pooled.|Baseline to Endpoint|Efficacy analyses were based on randomized participants with Baseline and any post-baseline data (intent-to-treat principle).||Proportion of Nights||Standard Deviation|Least Squares Mean
729834|NCT00383552|Secondary|Change From Baseline to Week 26 in Asthma Quality of Life Questionnaire With Standarized Activities (AQLQ[S]) Total Score|AQLQ(S) consists of 32 questions each scaled from 1 (worst case) to 7 (best case). The comparison was for MF/F vs placebo. Standard deviation was pooled.|Baseline to Week 26|Efficacy analyses were based on randomized participants with Baseline and any post-baseline data (intent-to-treat principle).||units on a scale||Standard Deviation|Least Squares Mean
729835|NCT00383552|Primary|Median Time-to-first Severe Asthma Exacerbation Over the 26-week Treatment Period|Severe asthma exacerbation refers to an occurrence of a decrease below 80% of Baseline in FEV1, a decrease below 70% of Baseline in PEF on 2 consecutive days or a clinical deterioration of asthma resulting in emergency treatment, hospitalization or treatment with asthma medication.|Across the 26 week treatment period|Medians for time-to-event outcomes are estimated for those who had events.||Days||Inter-Quartile Range|Median
729836|NCT00383552|Secondary|Change From Baseline to Week 26 in the Asthma Control Questionnaire (ACQ) Total Score|ACQ consists of seven questions each scaled from 0 (best case) to 6 (worst case). The comparison was for MF/F vs placebo. Standard deviation was pooled.|Baseline to Week 26|Efficacy analyses were based on randomized participants with Baseline and any post-baseline data (intent-to-treat principle).||units on a scale||Standard Deviation|Least Squares Mean
729837|NCT00383552|Primary|Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 12 in Forced Expiratory Volume (Liters) in 1 Second (FEV1)|The average of the two predose FEV1 measurements (30 minutes prior to dosing and 0 hour, immediately prior to dosing) at the Baseline Visit were subtracted from each of the serial measurements over the 12-hour period. The AUC was calculated based on these changes from Baseline evaluations. The comparison was for MF/F vs MF. Standard deviation was pooled.|Baseline to Week 12|Efficacy analyses were based on randomized participants with Baseline and any post-baseline data (intent-to-treat principle).||liters * hours||Standard Deviation|Least Squares Mean
729838|NCT00383565|Secondary|Median Overall Survival|Survival time is defined as the time from registration to death due to any cause, measured in months. The distribution of survival time estimated using the method of Kaplan-Meier.|5 Years|||months||Full Range|Median
729839|NCT00383565|Secondary|Median Progression Free-survival (PFS)|Time to disease progression is defined as the time from registration to documentation of disease progression.|2 Years|||months||Full Range|Median
729840|NCT00383565|Primary|Overall Objective Response Rate (Complete Response [CR] and Partial Response [PR]) After 6 Courses of Treatment|International Working Group response for non- Hodgkin's lymphoma: Complete Response (CR) - disappearance all detectable clinical/radiographic evidence of disease and disappearance of all disease-related symptoms (present before therapy) and normalization of those biochemical abnormalities; Partial Response (PR) - ≥50% decrease in sum products of greatest diameters (SPD) of 6 largest dominant nodes or nodal masses, selected by clearly measurable in at least two perpendicular dimensions, from disparate regions of body and no decrease in size of other nodes, liver, or spleen.|24 weeks (6 courses of 4 week cycles)|||participants|||Number
729841|NCT00383643|Primary|Assessment of Sleepiness|Current self-report on Epworth Sleepiness Scale (ESS) at week 12 of intervention. This measure consists of 8 scenarios in which the participant is asked to assess how likely s/he is to fall asleep. Scale: 0 = would never doze; 1 = slight chance of dozing; 2 = moderate chance of dozing; 3 = high chance of dozing. Responses are summed for a total score ranging from 0 to 24. The higher the score, the greater the self-reported sleepiness. Scores of 9 and below are considered in the normal range.|One month|All analysis are intent to treat. In the case of missing data, an average value of the available data points (weeks 4 & 8) were used to replace the missing value.||units on a scale||Standard Deviation|Mean
729842|NCT00383643|Primary|Assessment of Fatigue|Current self-report on Profile of Mood State -- Fatigue (POMS-F) at week 12 of intervention. This subscale of the POMS consists of 7 items each scored on a scale of 0 (not at all) to 4 (extremely) which are summed to provide a composite score of fatigue. The range is 0 to 28 for this subscale. Higher scores indicate more fatigue.|One month|All analysis are intent to treat. In the case of missing data, an average value of the available data points (weeks 4 & 8) were used to replace the missing value.||units on a scale||Standard Deviation|Mean
729843|NCT00383643|Primary|Assessment of Pittsburgh Sleep Quality Index (PSQI)|"Current self-report on Pittsburgh Sleep Quality Index (PSQI) at week 12 of intervention. Consisting of 19 items, the PSQI measures several different aspects of sleep which can be combined into one global score.
Each item measure is scored on a scale of 0 to 3 where 3 is the extreme negative. The composite PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality. Based on this questionnaire, a composite score of 5 or greater is indicative of poor sleep quality."|One month|All analysis are intent to treat. In the case of missing data, an average value of the available data points (weeks 4 & 8) were used to replace the missing value.||units on a scale||Standard Deviation|Mean
729844|NCT00383643|Primary|Assessment of Insomnia Severity Index|"Current self-report on Insomnia Severity Index at week 12 of treatment intervention. This is a seven-item questionnaire where the sum of the answers indicate the severity of insomnia. Total score categories:
0–7 = No clinically significant insomnia 8–14 = Subthreshold insomnia 15–21 = Clinical insomnia (moderate severity) 22–28 = Clinical insomnia (severe)"|12 weeks|All analysis are intent to treat. In the case of missing data, an average value of the available data points (weeks 4 & 8) were used to replace the missing value.||units on a scale||Standard Deviation|Mean
729845|NCT00383643|Primary|Assessment of Clinical Global Impression-change.|Clinician assessment of Clinical Global Impression-Change score at week 12 of treatment intervention. The Clinical Global Impression – Change scale is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the current time point. It is rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. One one clinician provided the ratings in this trial.|Baseline to week 12|All analysis are intent to treat. In the case of missing data, an average value of the available data points (weeks 4 & 8) were used to replace the missing value.||units on a scale||Standard Deviation|Mean
729846|NCT00383721|Secondary|Number of Participants With Mild, Moderate, or Severe COPD Exacerbations|"Mild = 12 or more inhalations/day of inhaled rescue medication or 2 or more
nebulized treatments/day of inhaled rescue medication. Moderate = treatment with
antibiotics or oral steroids. Severe = emergency room treatment or hospitalizations of survival curves. If an event was composed of multiple criteria, the most severe criteria was assigned to the event."|Endpoint (26 weeks)|ITT population||Participants|||Number
729847|NCT00383721|Secondary|Number of Participants With Partly Stable COPD|"Partly stable COPD was a composite measure that included the following COPD
outcomes: (1) No oral steroid rescue medication; (2) No AM or PM COPD weekly
average symptom score greater than 2 during at least 7 of 8 weeks; (3) No moderate or severe exacerbations; (4) No unscheduled visits due to COPD worsenings; (5) No study discontinuation due to treatment failure or treatment-related adverse event as determined by the investigator."|Endpoint (26 weeks)|ITT population||Participants|||Number
729848|NCT00383721|Secondary|Change From Baseline in Proportion of Chronic Obstructive Pulmonary Disease (COPD) Symptom-Free Nights (AM Diary Symptoms)|Prior to the use of study drug rescue medication (in the morning upon awakening) the participant evaluated the COPD symptoms of wheezing, cough, and difficulty breathing. A symptom-free night was defined as a combined score of 0 (no symptoms) across all three COPD symptoms evaluated the following morning. Proportion for Baseline included data from the last week before the first dose. Proportion for Endpoint included data across the entire 26-week treatment period.|Baseline to Endpoint (26 weeks)|ITT population||Proportion of symptom-free nights||Standard Deviation|Least Squares Mean
729849|NCT00383721|Secondary|Change From Baseline to Endpoint in St George's Respiratory Questionaire (SGRQ) Total Score|"SGRQ consisted of 76 items aggregated into 3 component scores: symptoms
(frequency/severity), activity (cause or limited by breathlessness), impact (social functioning, psychological disturbances from airway disease), & total score. Best health scores have a low numeric value. All component scores & total score ranged from 0-100, with a higher score indicating greater disease burden. A 4-point increase over placebo (and Baseline) was considered the minimum clinically important difference. Endpoint was the last post-baseline non-missing result through the 26 week evaluation carried forward."|Baseline to Endpoint (26 weeks)|ITT population||Score on a scale||Standard Deviation|Least Squares Mean
729850|NCT00383721|Primary|Mean Change From Baseline to Week 13 Endpoint in AM Predose FEV1|Endpoint was the last post-baseline non-missing result through Week 13 carried forward.|Baseline to Endpoint (13 weeks)|ITT population||Liters||Standard Deviation|Least Squares Mean
729851|NCT00383721|Primary|Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 13 in Forced Expiratory Volume (Liters) in 1 Second (FEV1)|FEV1 AUC was standardized to liters. Endpoint was the last post-baseline non-missing result through Week 13 carried forward.|Baseline to Endpoint (13 weeks)|Intent-to-treat (ITT) population||Liters||Standard Deviation|Least Squares Mean
729852|NCT00383747|Secondary|Effects of Nicotine Patch Compared With Placebo in Non- Smokers With Schizophrenia and Control Groups on Lateralized Psychomotor Speed Measured by the Grooved Pegboard|The Grooved Pegboard (model 32025 Lafayette Instrument Company, Lafayette, IN, USA). In this test of lateralized psychomotor speed, participants had 45 s to place as many pegs as possible into grooves on a board using their dominant hand. The number of correctly placed pegs were recorded for each of the two trials.It was measured 3 hrs after application of the patch after CPT, Stroop and Letter number sequencing|Visit 1 and visit 2 (separated by an interval of 7-10 days)|||number of pegs into grooves||Standard Deviation|Mean
729853|NCT00383747|Secondary|Effects of Nicotine Patch Compared With Placebo in Non- Smokers With Schizophrenia and Control Groups on Letter Number Sequencing|This measure of working memory and auditory attention was performed under two conditions. In the first condition, participants were read progressively longer lists of letters and numbers and instructed to repeat these exactly as given, without reordering. In the second condition, participants were read progressively longer lists of numbers and letters and instructed to re-order the list and give the numbers first in ascending order and then the letters in alphabetical order (WMS-III). The sum of the trial scores provided the item score and the sum of the item scores provided the total score.It was measured 3 hrs after application of the patch, after CPT and Stroop. The total score ranges from 0 to 21.Higher scores of Letter number sequencing means better working memory and auditory attention|Visit 1 and visit 2 (separated by an interval of 7-10 days)|||units on a scale||Standard Deviation|Mean
729854|NCT00383747|Secondary|Effects of Nicotine Patch Compared With Placebo in Non- Smokers With Schizophrenia and Control Groups on Visual Attention and Cognitive Interference as Measured by Three Card Stroop|This standard test of visual attention, processing speed and cognitive interference was performed, in which three cards (Stoelting Co., Wood Dale, IL, USA) were presented in order: the first card with color names, the second with colored patches of ink and the third with color namesprinted in incongruously colored ink. Participants were asked to read or name as many colors as possible in 45 s for each condition. The raw interference score was calculated by subtracting the predicted color-word score (calculated using raw word and color scores) from the observed raw color-word score. This value was converted to an interference T score by referring to a standardized table. A higher interference T score indicates better task performance with less interference. It was measured 3 hrs after application of the patch, after CPT|Visit 1 and visit 2 (separated by an interval of 7-10 days)|||score||Standard Deviation|Mean
729855|NCT00383747|Primary|Effects of Nicotine Patch Compared With Placebo in Non- Smokers With Schizophrenia and Control Groups on Attention Measured by the Continuous Performance Test Identical Pairs Version|The primary outcome measure was attention as measured by the Continuous Performance Test Identical Pairs (CPT-IP) Version 4.0 (Biobehavioral Technologies, New York, USA), developed for use in patients with schizophrenia and normal controls. In this task, participants were asked to respond when two identical pairs of numbers were presented in sequence by pressing a mouse key as quickly as possible using the dominant hand.The stimuli were presented with increasing cognitive load in successive blocks: two-,three- and four-digit target in the first, second and third block, respectively. Hit reaction time, a standard outcome variables on the CPTIP, is presented here. It was measured 3 hrs after application of the patch|Visit 1 and visit 2 (separated by an interval of 7-10 days)|||milliseconds||Standard Deviation|Mean
729868|NCT00383786|Primary|Changes in CAPS Scores.|"The Clinician-Administered PTSD Scale (CAPS) is the gold standard in PTSD assessment. The CAPS is a 30-item structured interview that corresponds to the DSM-IV criteria for PTSD. This is a 17-item core symptom scale, measuring both frequency and intensity of symptoms, with the most frequently used scoring rule is to count a symptom as present if it has a frequency of 1 or more and an intensity of 2 or more. A PTSD diagnosis is made if there is at least 1 B symptom, 3 C symptoms, and 2 D symptoms as well as meeting the other diagnostic criteria. Scores range from 0-136 0 (best possible outcome) to 136 (worst possible outcome). The relevant time-points for reporting change were at baseline and 8 weeks."|Baseline, 8 weeks|20 patients randomized to drug were included in the primary analysis as 2 our of the 22 randomized were excluded because they did not receive a week 1 assessment. 19/25 randomized to placebo were included in the analysis after 6 were excluded due to not receiving week 1 assessments.||scores on a scale||Standard Deviation|Mean
729869|NCT00383942|Primary|Proportion of Women Undergoing Cesarean Section for Fetal Intolerance of Labor|The number of women undergoing cesarean section will be compared between the misoprostol arm and EASI arm. The primary hypothesis is that the odds of receiving a cesarean section is lower among patients assigned to EASI when compared to patients who receive misoprostol.|At time of delivery|No participants are included in this analysis because the trial was terminated prematurely.|||||
729870|NCT00384033|Secondary|Change From Baseline in Visual Analog Scale-Pain Intensity (VAS-PI) Overall and Subcomponent Score at Week 8 or FOT Evaluation|VAS-PI scale assesses intensity of back pain, chest pain, arms, legs or joint pain as well as overall pain intensity where 100 mm line (VAS) is marked by participant and intensity of pain ranges from 0 millimetre (mm) = no pain to 100 mm = worst possible pain. There were separate 0 to 100 mm VAS lines for each subcomponent of VAS-PI.|Baseline and Week 8 or FOT|ITT population included all randomized participants who had a baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study medication, and had at least 1 primary efficacy evaluation after the first dose of double-blind study medication.||mm||Standard Error|Mean
729871|NCT00384033|Secondary|Change From Baseline in Covi Anxiety Scale at Week 8 or FOT Evaluation|COVI anxiety scale measures the severity of anxiety symptoms on 3 items: verbal report, behavior and somatic complaints. Each dimension is assessed using a 5-point scale: 1 = not at all, 2 = somewhat, 3 = moderately, 4 = considerably, to 5 = Very much. Worst value is 15 and best value is 3.|Baseline and Week 8 or FOT|ITT population included all randomized participants who had a baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study medication, and had at least 1 primary efficacy evaluation after the first dose of double-blind study medication.||Units on a Scale||Standard Error|Mean
729872|NCT00384033|Secondary|Change From Baseline in the HAM-D Energy Subscale Score at Week 8 or FOT Evaluation|HAM-D energy subscale is a subset of the HAM-D17 that assesses 4 items associated with major depression. The scale uses HAM- D17 items 1, 7, 8 and 14. Item 14 is scored 0 to 2 (0=none/absent to 2=most severe) and all others are scored 0 to 4 (0=none/absent to 4=most severe).|Baseline and Week 8 or FOT|ITT population included all randomized participants who had a baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study medication, and had at least 1 primary efficacy evaluation after the first dose of double-blind study medication.||Units on a Scale||Standard Error|Mean
729873|NCT00384033|Secondary|Change From Baseline in HAM-D6 Total Score at Week 8 or FOT Evaluation|HAM-D6: a standardized, clinician-administered rating scale that assesses 6 items characteristically associated with major depression and is a subset of HAM-D17. HAM-D6 score ranges from 0-22. The scale uses HAM-D17 items: 1, 2, 7, 8, 10 and 13. Item 13 is scored 0-2 (0=none and 2=severe) and all others are scored 0-4 (0=none/absent and 4=most severe).|Baseline and Week 8 or FOT|ITT population included all randomized participants who had a baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study medication, and had at least 1 primary efficacy evaluation after the first dose of double-blind study medication.||Units on a Scale||Standard Error|Mean
729874|NCT00384033|Secondary|Change From Baseline in the Lassitude Item of the MADRS Scale at Week 8 or FOT Evaluation|Lassitude item of MADRS represents a difficulty in getting started or slowness in initiating and performing everyday activities. It is rated on a scale of 0-6: 0 = hardly any difficulty in getting started/no sluggishness; 2 = difficulties in starting activities; 4 = difficulties in starting simple routine activities which are carried out with effort; 6 = complete lassitude/unable to do anything without help.|Baseline and Week 8 or FOT|ITT population included all randomized participants who had a baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study medication, and had at least 1 primary efficacy evaluation after the first dose of double-blind study medication.||Units on a Scale||Standard Error|Mean
729875|NCT00384033|Secondary|Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score at Week 8 or FOT Evaluation|MADRS measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline and Week 8 or FOT|ITT population included all randomized participants who had a baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study medication, and had at least 1 primary efficacy evaluation after the first dose of double-blind study medication.||Units on a Scale||Standard Error|Mean
729876|NCT00384033|Secondary|Change From Baseline in Mean CGI-S Score at Week 8 or FOT Evaluation|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill participants). Higher score = more affected.|Baseline and Week 8 or FOT|ITT population included all randomized participants who had a baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study medication, and had at least 1 primary efficacy evaluation after the first dose of double-blind study medication.||Units on a Scale||Standard Error|Mean
729877|NCT00384033|Secondary|Number of Participants With Categorical Scores on CGI-Improvement (CGI-I) Score at Week 8 or FOT Evaluation|CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale relative to the baseline assessment. Higher score = more affected.|Week 8 or FOT|ITT population included all randomized participants who had a baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study medication, and had at least 1 primary efficacy evaluation after the first dose of double-blind study medication.||Participants|||Number
729878|NCT00384033|Primary|Change From Baseline in HAM-D17 Total Score at Week 8 or Final On-therapy (FOT) Evaluation|HAM-D17: a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0 = none/absent and 4 = most severe, for a maximum total score of 50.|Baseline and Week 8 or FOT|Intent-to-treat (ITT) population included all randomized participants who had a baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study medication, and had at least 1 primary efficacy evaluation after the first dose of double-blind study medication.||Units on a Scale||Standard Error|Mean
729879|NCT00384059|Secondary|Geometric Mean Titer (GMT) of Meningococcal C Antigen as Measured by SBA in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose||one month after toddler dose (13 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations;(N)= number of participants with a determinate antibody concentration/titer for the specified concomitant antigen.||titer||95% Confidence Interval|Geometric Mean
729880|NCT00384059|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events|Systemic events (fever ≥ 38 degrees Celsius [C] but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased appetite, irritability, increased sleep, decreased sleep, use of medication (Meds) to prevent symptoms, and use of medication to treat symptoms) were collected using an electronic diary; percentage of participants with each event was evaluated.|During the 4-day period after each dose|Safety population included all participants who received at least 1 dose of vaccine; (n) = number of participants reporting yes for at least 1 day or no for all days.||Percentage of Participants|||Number
729881|NCT00384059|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Local Reactions|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|During the 4-day period after each dose|The safety population included all participants who received at least 1 dose of vaccine; (n)= number of participants reporting yes for at least 1 day or no for all days.||Percentage of Participants|||Number
729882|NCT00384059|Primary|Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose.|Antibody concentration/geometric mean concentration (GMC) as measured by ELISA for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented with corresponding 2-sided 95% CI.|one month after infant series dose 2 (5 months of age) and before and after toddler dose (12 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate antibody concentration for the specified serotype.||μg/mL||95% Confidence Interval|Geometric Mean
729883|NCT00384059|Primary|Percentage of Participants in the 13vPnC Group Achieving a Serotype-specific IgG Antibody Concentration ≥0.35 µg/mL Measured 1 Month After the 2-dose Infant Series, Before and After the Toddler Dose|Percentages of participants achieving WHO predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|one month after infant series dose 2 (5 months of age), before and after toddler dose (12 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate igG antibody concentration to the given serotype.||Percentage of Participants||95% Confidence Interval|Number
729884|NCT00384059|Secondary|Geometric Mean Antibody Concentration for Haemophilus Influenzae Type b PRP in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose.||one month after toddler dose (13 months of age)|Evaluable immunogenicity (per protocol) population of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N) = number of participants with a determinate antibody concentration/titer to the specific concomitant antigen.||μg/mL||95% Confidence Interval|Geometric Mean
729885|NCT00384059|Primary|Geometric Mean Antibody Concentration of Pertusis Filamentous Haemagglutinin (FHA), Pertussis Toxoid (PT), Pertactin (PRN), and Fimbrial Agglutinogens (FIM) as Measured by ELISA in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series||one month after infant series dose 2 (5 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations;(n) = number of participants with a determinate antibody concentration/titer for the specified concomitant antigen.||EU/mL||95% Confidence Interval|Geometric Mean
729886|NCT00384059|Primary|Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series||one month after infant series dose 2 (5 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations;(N) = number of participants with a determinate antibody concentration/titer for the specified concomitant antigen.||μg/mL||95% Confidence Interval|Geometric Mean
729887|NCT00384059|Primary|Geometric Mean Titer (GMT) of Meningococcal C Antigen as Measured by SBA in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series||one month after infant series dose 2 (5 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations;(N) = number of participants with a determinate antibody concentration/titer for the specified concomitant antigen.||titer||95% Confidence Interval|Geometric Mean
729931|NCT00391586|Primary|Toxicity Profile|Toxicities are assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events, version 3.0. Toxicities are reported as the number of patients who experienced grade 3 or grade 4 adverse events after receiving at least one dose of on-study treatment.|28 days after last on-study treatment|||participants|||Number
729888|NCT00384059|Secondary|Percentage of Participants Achieving a Predefined Antibody Level for Haemophilus Influenzae Type b in the 13vPnC Group Relative to the 7vPnC Group After the Toddler Dose.||one month after toddler dose (13 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N) = number of participants with a determinate posttoddler dose antibody concentration to the given concomitant antigen.||Percentage of Participants||95% Confidence Interval|Number
729889|NCT00384059|Secondary|Percentage of Participants Achieving an SBA Titer ≥1:8 for Meningococcal C in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose.||one month after the toddler dose (13 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n)= number of participants with a determinate posttoddler dose antibody concentration to the given concomitant antigen.||Percentage of Participants||95% Confidence Interval|Number
729890|NCT00384059|Primary|Percentage of Participants Achieving a Meningococcal C Serum Bactericidal Assay (SBA) Titer ≥1:8 and Predefined Antibody Levels for Pertussis and Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series.|Percentage of participants achieving a meningococcal C SBA serum antibody titer ≥1:8 and predefined antibody threshold levels with the corresponding 95% CI for concomitant antigens polyribosylribitol phosphate (PRP) in haemophilus influenzae type b [Hib](≥0.15 μg/mL or ≥ 1.0 μg/mL), pertussis toxoid [PT], filamentous haemagglutinin, pertactin [FHA], and pertactin (PRN) (≥5 Elisa Units EU/mL) and fimbrial agglutinogens [FIM] (≥2.2 EU/mL) are presented.|One month after infant series dose 2 (5 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate postinfant series antibody concentration to the given concomitant antigen.||Percentage of participants||95% Confidence Interval|Number
729891|NCT00384085|Secondary|Adjusted Hypoglycemic Event Rates (Event/Patient-year)|"Adjusted Hypoglycemic event rate: Total # of events for a given type of hypoglycemia divided by the total exposure to study drug (patient-years). Rates are estimated from a general linear model adjusted for baseline BMI and oral agent combination of antidiabetic medications on which the patient entered the study.
An event is included if the hypoglycemic event start date is within the treatment period (i.e., from the Randomization date to & including 1 day after the date of last dose of study drug)."|Week 60|The analysis was performed on the exposed population (i.e. safety population) regardless of enrollment in a non-GCP compliant site.||event per patient year||Standard Error|Mean
729892|NCT00384085|Secondary|Adjusted Incidence Rate of Hypoglycemia|"Adjusted incidence rate of hypoglycemia: estimated percent of patients having at least 1 event of a given type of hypoglycemia.
A severe Hypoglycemic Event (HE) is one where patient requires assistance. It is confirmed either by a prompt response to certain countermeasures or by a blood Glucose (BG) <36 mg/dL during or soon after the event.
A serious HE is one where the patient has loss of consciousness, coma, seizure, or convulsion.
Nocturnal = events occurring between 00:00 & 06:00 based on a 24-hour clock.
An event is included if the HE start date is within the treatment period."|Week 60|The analysis was performed on the exposed population (i.e. safety population) regardless of enrollment in a non-GCP compliant site.||estimated percentage per patient||Standard Error|Mean
729893|NCT00384085|Secondary|Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) <7.0% at Week 60 Without a Severe Hypoglycemic Event or a Symptomatic Hypoglycemic Event With an Self Monitoring Blood Glucose (SMBG) <50 mg/dl|"Severe hypoglycemia was defined as an event with clinical symptoms that are considered to result from hypoglycemia in which the patient required assistance of another person and one of the following: the event was associated with a measured blood glucose level below 36 mg/dL or the event was associated with prompt recovery after oral carbohydrate, iv glucose, or glucagon administration.
A symptomatic hypoglycemic event was defined as a hypoglycemic episode with an associated SMBG value of <50 mg/dL with reported symptoms."|At week 60|Analysis was performed on the mITT population. Patients from non-GCP compliant sites (8 from Lantus/Apidra-3, 9 from Lantus/Apidra-1 & 7 from Novolog Mix arms) were excluded from this analysis.||percentage of participants|||Number
729894|NCT00384085|Secondary|Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) <7.0% at Week 60 (Lantus/Apidra-1 Versus Novolog Mix 70/30)|Patients who achieved an HbA1c value <7.0% were defined as responders. Patients who did not achieve HbA1c values <7.0% and patients with missing HbA1c values were considered nonresponders.|At week 60|Analysis was performed on the modified intent-to-treat population which consisted of all patients who were randomized & for whom there was a baseline observation & at least 1 postbaseline (on therapy) observation for HbA1c. Patients from non-GCP compliant sites (9 for Lantus/Apidra-1 & 7 for Novolog Mix arms) were excluded from this analysis.||percentage of participants|||Number
729895|NCT00384085|Secondary|Absolute Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 60 (Lantus/Apidra-3 Versus Novolog Mix 70/30)|Absolute Change in HbA1c from Baseline to Week 60.|From baseline to week 60|Analysis was performed on the modified ITT (mITT) population which consisted of all patients who were randomized, and for whom there was a baseline observation and at least 1 postbaseline (on therapy) observation for HbA1c. Patients from non-GCP compliant sites (8 from Lantus/Apidra-3 & 7 from Novolog Mix arms) were excluded from this analysis.||percent HbA1c||Standard Error|Least Squares Mean
729896|NCT00384085|Primary|Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) < 7.0% at Week 60 (Lantus/Apidra-3 Versus Novolog Mix 70/30 - ITT Population With All Sites) (Sensitivity Analysis)|Responders defined as patients who achieved an HbA1c value <7.0% versus nonresponders. Patients who did not achieve an HbA1c value <7.0% and patients with a missing HbA1c value at Week 60 were considered to be nonresponders.|At week 60|Analysis was performed on the Intent To Treat (ITT) population which consisted of all patients who were randomized, and for whom there was any post-baseline follow-up information. Patients from non-GCP compliant sites were included in this analysis. This analysis was performed to ensure that study results were not compromised.||percentage of participants|||Number
729932|NCT00391586|Primary|Progression-free Survival (PFS)||5 years|This study was terminated early; no results are available. The number of patients who completed treatment and therefore the number of evaluable patients was too low to accurately calculate endpoints.|||||
729933|NCT00391599|Primary|Number of Participants Had Spontaneous Feces|occurrence of spontaneous feces|On postoperative day 1|||participants|||Number
729897|NCT00384085|Primary|Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 60 (Lantus/Apidra-1 Versus Novolog Mix 70/30)Per Protocol Population|Absolute Change in HbA1c from Baseline to Week 60. If the Week 60 HbA1c evaluation was missing, the patient was counted as having not completed per protocol.|At week 60|Analysis was performed on the Per Protocol (PP) population which included randomized patients who had no major protocol violation and who had HbA1c recorded for both Baseline & Week 60. Patients from non-GCP compliant sites were, by population definition, excluded from this analysis.||percent HbA1c||Standard Error|Least Squares Mean
729898|NCT00384085|Primary|Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) < 7.0% at Week 60 (Lantus/Apidra-3 Versus Novolog Mix 70/30 - Intent To Treat (ITT) Population Without Good Clinical Practices (GCP) Noncompliant Sites)|Responders defined as patients who achieved an HbA1c value <7.0% versus nonresponders. Patients who did not achieve an HbA1c value <7.0% and patients with a missing HbA1c value at Week 60 were considered to be nonresponders.|At week 60|Analysis was performed on Intent-To-Treat population which consisted of all patients who were randomized and for whom there was any post-baseline follow-up information. Patients from nonGCP compliant sites were excluded from this analysis. Additional analysis including those patients were completed to ensure that study results were not compromised.||percentage of participants|||Number
729899|NCT00384176|Secondary|Time to Worsening of Health Related Quality of Life (QOL) Based on the FACT Colorectal Symptom Index (FCSI)|Time to worsening of symptoms, as measured by the FACT colorectal symptom index (FCSI), will be defined as the time when a sustained clinically important deterioration in the total score from the FCSI has been recorded.|Baseline through to data cut-off|||Days||Inter-Quartile Range|Median
729900|NCT00384176|Secondary|Percentage Change in Tumour Size|Percentage change in tumour size from baseline to first RECIST assessment (Week 8) ((Week 8 - baseline)/baseline)*100|Baseline to Week 8|No statistical analyses were performed on the 30mg group. Patients had to have both a baseline and post-baseline (week 8) value to be included in the analysis. If patients did not have a week 8 assessment they were not included.||Percentage change in tumour size||Standard Deviation|Mean
729901|NCT00384176|Secondary|Duration of Response|Duration of Response is calculated as the time from the first recording of CR/PR until the patient progresses, regardless of whether the patient was still taking study medication. Only confirmed responses are included in the calculation. For patients who had not progressed, the end date used in the calculation of duration of response is the data cut-off date of 15th November 2009.|Up until data cut-off date of 15/11/2007|Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation. The decision was taken to continue with cediranib 20 mg. No statistical analyses were performed on the 30mg group.||Months||Inter-Quartile Range|Median
729902|NCT00384176|Secondary|Objective Response Rate|"Objective response rate is Complete Response (CR) + Partial Response (PR) as defined below:
CR = Disappearance of all target lesions. PR = At least a 30% decrease in the sum of longest diameters (LDs) of target lesions, taking as reference the baseline sum of LDs."|Up until data cut-off|Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation. The decision was taken to continue with cediranib 20 mg. No statistical analyses were performed on the 30mg group.||Participants|||Number
729903|NCT00384176|Secondary|Overall Survival|Number of months from randomisation to the date of death from any cause|Randomisation until data cut-off|Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation. The decision was taken to continue with cediranib 20 mg. No statistical analyses were performed on the 30mg group.||Months||Inter-Quartile Range|Median
729904|NCT00384176|Primary|Progression Free Survival|Progression is defined as the number of months from randomisation until progressive disease based on RECIST (progression of target lesions, clear progression of existing non-target lesions or the appearance of one or more new lesions) or death in the absence of progression.|Baseline then at Weeks 8, 16, 24 and then every 12 weeks until progression|Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation. The decision was taken to continue with cediranib 20 mg. No statistical analyses were performed on the 30mg group.||Months||Inter-Quartile Range|Median
729905|NCT00384189|Secondary|Change From Baseline in Pediatric Asthma Caregiver’s Quality of Life Questionnaire (PACQLQ) Overall|PACQLQ assesses the impact of the child’s asthma on the quality of life of the caregiver. The PACQLQ consists of 13 items in 2 domains evaluating activity limitations and emotional function. Caregivers answered each question using a 7-point scale from 1= maximum impairment to 7=no impairment about their experience during the previous week. Total possible score ranging from 13 (worst) to 91(best). Higher change from Baseline scores are the best. Analysis of covariance (ANCOVA) model with the baseline value and age as covariates was used for analysis.|Baseline and Week 12|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis.||score on a scale||Standard Error|Least Squares Mean
729906|NCT00384189|Secondary|Change From Baseline in Pediatric Asthma Quality of Life Questionnaire Standard [PAQLQ(S)] Overall Score|PAQLQS is a disease specific instrument to assess the impact of asthma on the patient’s quality of life. The PAQLQS consists of 23 items in 3 domains evaluating activity limitations, symptoms and emotional function. Patients answered each question using a 7-point scale from 1= maximum impairment to 7=no impairment) about their experience during the previous week. Total possible score ranging from 23 (worst) to 161(best). Higher change from Baseline scores are the best. Analysis of covariance (ANCOVA) model with the baseline value and age as covariates was used for analysis.|Baseline and Week 12|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis.||score on a scale||Standard Error|Least Squares Mean
729907|NCT00384189|Secondary|Percentage of Days With Asthma Control Based on Symptoms, Use of Rescue Medication and Morning PEF|Control of asthma was evaluated on a daily basis (24 hours) using the following variables: asthma symptoms, use of rescue medication, and morning (am) PEF. The median percentage of days with asthma control is presented.|28 days prior to last visit (Up to 12 Weeks)|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis.||percentage of days||Full Range|Median
729908|NCT00384189|Secondary|Change in Use of Rescue Medications|The daily use of rescue medication (salbutamol) was recorded in the electronic diary in the morning and the evening. A negative change from Baseline indicates improvement.|Baseline and Week 12|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis. Last Observation carried forward.||puffs/day||Standard Deviation|Mean
729909|NCT00384189|Secondary|Change in Asthma Symptom Total Score|Measurements of both nighttime and daytime asthma symptoms were assessed on a daily basis by the patient in the electronic diary, according to the following scales: Nighttime Asthma Score using a 5 point scale: 0=no asthma symptoms, slept through the night to 4=bad night, awake most of the night because of asthma. Daytime Asthma Score using a 5 point scale: 0=very well, no asthma symptoms to 4=asthma very bad, unable to carry out daily activities as usual. Total possible overall daily score range from 0(best) to 4 (worst). A negative change from Baseline indicated improvement.|Baseline and Week 12|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis. Last observation carried forward.||score on a scale||Standard Deviation|Mean
729910|NCT00384189|Secondary|Change From Baseline in Diurnal PEF Fluctuations|PEF is the maximum speed of expiration. A portable electronic PEF meter was used for the home PEF readings. The patients recorded PEF daily, in the morning immediately after getting up. Readings were done preferably at least 4 hours after use of rescue medication and before inhalation of the study medication. At each measurement, three readings were obtained in the standing position. All three values were recorded in the diary; the highest value was used for evaluation. A negative change from Baseline indicates improvement. Analysis of covariance (ANCOVA) model with the Baseline value and age as covariates was used for analysis.|Baseline and Week 12|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis.||percent change||Standard Deviation|Mean
729911|NCT00384189|Secondary|Change From Baseline in Evening PEF From Diary|PEF is the maximum speed of expiration. A portable electronic PEF meter was used for the home PEF readings. The patients recorded PEF daily, in the morning immediately after getting up. Readings were done preferably at least 4 hours after use of rescue medication and before inhalation of the study medication. At each measurement, three readings were obtained in the standing position. All three values were recorded in the diary; the highest value was used for evaluation. The higher change from Baseline values are the best. Analysis of covariance (ANCOVA) model with the Baseline value and age as covariates was used for analysis.|Baseline and Week 12|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis. Last observation carried forward.||liters/minute||Standard Error|Least Squares Mean
729912|NCT00384189|Secondary|Change From Baseline in Morning PEF From Diary|PEF is the maximum speed of expiration. A portable electronic PEF meter was used for the home PEF readings. The patients recorded PEF daily, in the morning immediately after getting up. Readings were done preferably at least 4 hours after use of rescue medication and before inhalation of the study medication. At each measurement, three readings were obtained in the standing position. All three values were recorded in the diary; the highest value was used for evaluation. The higher change from Baseline values are the best. Analysis of covariance (ANCOVA) model with the Baseline value and age as covariates was used for analysis.|Baseline and Weeks 1 thru 12|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis.||liters/minute||Standard Error|Least Squares Mean
729913|NCT00384189|Secondary|Change From Baseline in Lung Function Variable PEF by Spirometry|Spirometry was performed according to local standards. PEF is the maximum speed of expiration. Analysis was ANCOVA with factors value at Baseline, treatment, age, sex, center pool, ICS pretreatment, spacer use and asthma severity. Higher change numbers indicate better lung function.|Baseline and Week 12|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis. Last Observation carried forward.||liters/minute||Standard Error|Least Squares Mean
729914|NCT00384189|Secondary|Change From Baseline in Lung Function Variable Forced Expiratory Volume in One Second (FEV1)|Spirometry was performed according to local standards. FEV1 is the maximal amount of air forcefully exhaled from the lungs in one second. Higher change numbers indicate better lung function.|Baseline and Week 12|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis.||liters||Standard Error|Least Squares Mean
729915|NCT00384189|Secondary|Percentage of Days With Asthma Control Based on Symptoms, Use of Rescue Medication, Morning PEF and PEF Fluctuation|Control of asthma was evaluated on a daily basis (24 hours) using the following variables: asthma symptoms, use of rescue medication, morning (am) PEF and PEF fluctuation. The median percentage of days with asthma control is presented.|28 days prior to last visit (Up to 12 Weeks)|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis.||percentage of days||Full Range|Median
729916|NCT00384189|Secondary|Time to First Event of Lack of Efficacy (LOE) by Week 12|Kaplan Meier Estimates of the probability of not experiencing LOE by Week 12 was measured. LOE was reached if any of the following criteria occurred during the treatment period: • asthma exacerbation (a worsening of asthma symptoms requiring a change in medication; • nocturnal awakenings due to asthma on any 4 or more nights during any 7-consecutive-day period; • use of more than 8 puffs/day of salbutamol on any 4 or more days during any 7-consecutive-day period; • decrease in morning PEF to <80% of randomization value on any 4 consecutive days during the treatment period.|12 weeks|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis.||Percent|||Number
729934|NCT00391599|Primary|Number of Participants With Gas Passage|gas passage: present|On postoperative day 1|||participants|||Number
729935|NCT00391599|Primary|Number of Participants With Bowel Sounds|bowel sounds: present|On postoperative day 1|||participants|||Number
729917|NCT00384189|Primary|Change From Baseline in Morning Peak Expiratory Flow (PEF)|PEF is the maximum speed of expiration. A portable electronic PEF meter was used for the home PEF readings. The patients recorded PEF daily, in the morning immediately after getting up. Readings were done preferably at least 4 hours after use of rescue medication and before inhalation of the study medication. At each measurement, three readings were obtained in the standing position. All three values were recorded in the diary; the highest value was used for evaluation. The higher change from Baseline values are the best. Analysis of covariance (ANCOVA) model with the baseline value and age as covariates was used for analysis. Last observation carried forward.|Baseline and Week 12|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis.||liters/minute||Standard Error|Least Squares Mean
729918|NCT00391365|Secondary|Bodily Pain Section of Short Form-36 (SF-36)|"Patient reported bodily pain data from the SF-36, a thirty-six item survey evolved from the RAND 36.
Number shows change in outcome from pre-op to 3 years by surgery type, with a higher score implying an improved outcome (scale range 0 - 100.)"|Over the course of 3 years.|The study started with 103 subjects in the arthrodesis group, and 170 in the arthroplasty group. 78 subjects in the arthrodesis group completed the Year 3 assessment, and 151 in the arthroplasty group. Analysis was done on the SF-36 bodily pain data collected from 93 arthrodesis subjects, and 157 arthroplasty subjects.||units on a scale||Standard Error|Mean
729919|NCT00391365|Secondary|Physical Function Section of Short Form-36 (SF-36)|"Patient reported physical function data from the SF-36, a thirty-six item survey evolved from the RAND 36.
Change in outcome from pre-op to 3 years by surgery type, with a higher score implying an improved outcome (scale range 0 - 100.)"|Over the course of 3 years.|The study started with 103 subjects in the arthrodesis group, and 170 in the arthroplasty group. 78 subjects in the arthrodesis group completed the Year 3 assessment, and 151 in the arthroplasty group. Analysis was done on the SF-36 physical function data collected from 93 arthrodesis subjects, and 157 arthroplasty subjects.||units on a scale||Standard Error|Mean
729920|NCT00391365|Primary|Musculoskeletal Functional Assessment (MFA)|"Patient reported data using the MFA, a general functional assessment intended as a tool for evaluation of patients' perceptions of their physical, psychological, and social well-being that asks patients to assess their function on 100 items.
Number shows change in outcome from pre-op to 3 years by surgery type, with a lower score implying an improved outcome (scale range 0 -100.)"|Over the course of 3 years|The study started with 103 subjects in the arthrodesis group, and 170 in the arthroplasty group. 78 subjects in the arthrodesis group completed the Year 3 assessment, and 151 in the arthroplasty group. Analysis was done on the MFA data collected from 99 arthrodesis subjects, and 165 arthroplasty subjects.||units on a scale||Standard Error|Mean
729921|NCT00391391|Secondary|Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds|Solicited injection site reactions: Pain, Redness, Swelling, Induration and Ecchymosis. Solicited Systemic reaction: Fever (Temperature), Headache, Malaise, and Myalgia.|Day 0 to Day 7 post-vaccination|Safety parameters were determined post-vaccination in the safety, intend-to-treat population.||Participants|||Number
729922|NCT00391391|Secondary|Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.|Solicited injection site reactions: Tenderness, Redness, Swelling, Induration and Ecchymosis. Solicited Systemic reaction: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of Appetite, and Irritability.|Day 0 to Day 7 post-vaccination|Safety parameters were determined post-vaccination in the safety, intend-to-treat population.||Participants|||Number
729923|NCT00391391|Secondary|Percentage of Participants That Achieved Seroconversion Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine|Seroconversion was defined as the conversion to a post-vaccination titer of ≥ 40 for subjects with pre-vaccination titer < 10, or at least a 4-fold increase in post vaccination titer for subjects with pre vaccination titer ≥ 10.|Day 28 post-vaccination|Seroconversion to vaccine antigens were determined in the per-protocol population||Percentage of Participants|||Number
729924|NCT00391391|Secondary|Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine|"Seroprotection was defined as participants achieving a post-dose antibody titers ≥40.
Antibody titers against each strain of influenza hemagglutinin were measured in the sera using the hemagglutination inhibition (HI) technique."|Day 28 post-vaccination|Seroprotection to vaccine antigens were determined in the per-protocol population||Percentage of Participants|||Number
729925|NCT00391391|Secondary|Percentage of Participants That Achieved A 4-Fold Rise in Serum HAI Antibody Titer Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine|Antibody titers against each strain of influenza hemagglutinin were measured in the sera using the hemagglutination inhibition (HI) technique.|Day 28 post-vaccination|4-Fold Rise in Serum HAI Antibody Titers were determined in the per-protocol population||Percentage of Participants|||Number
729926|NCT00391391|Primary|Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine|Antibody titers against each strain of influenza hemagglutinin were measured in the sera using the hemagglutination inhibition (HI) technique.|Day 0 and Day 28 post-vaccination|Geometric Mean Titers were determined in the per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
729927|NCT00391443|Secondary|Percentage of Patients Who Experienced Either Disease Worsening or Death at 1 Year.|Disease worsening was defined as an event of worsening of pulmonary function tests (PFT) or acute exacerbation of idiopathic pulmonary fibrosis (IPF).|12 months|ITT population||percentage of participants with event||95% Confidence Interval|Number
729928|NCT00391443|Primary|Time to Occurrence of Disease Worsening or Death up to End of Study.|Disease worsening was defined as an event of worsening of pulmonary function tests (PFT) or acute exacerbation of idiopathic pulmonary fibrosis (IPF).|36 months|The primary analysis was performed on the Intent To Treat (ITT) population.||participants with event|||Number
729929|NCT00391469|Secondary|Neurologic Status at Discharge-full Recovery||at time of discharge|||participants|||Number
729930|NCT00391469|Primary|Number Alive at Hospital Discharge||at hospital discharge|||participants|||Number
729959|NCT00392678|Secondary|Need for Rescue Therapy|This aim was proposed for the TINSAL-T2D stage 2 trial and is separately reported.|14 weeks||||||
729936|NCT00391625|Secondary|Percent Change From Baseline in Spleen Size||Baseline, Month 24, then every 9 or 12 months|ITT (One patient was excluded due to an intravascular metallic device that prevented accurate spleen evaluation.)||Percent Change from Baseline||Standard Error|Mean
729937|NCT00391625|Secondary|Percent Change From Baseline in Liver Volume||Baseline, Month 24, then every 9 or 12 months|ITT||Percent Change from Baseline||Standard Error|Mean
729938|NCT00391625|Secondary|Percent Change From Baseline in Platelet Counts||Baseline, then every 12 months|ITT patient population||Percent Change from Baseline||Standard Error|Mean
729939|NCT00391625|Secondary|Percent Change From Baseline in Hemoglobin Concentration||Baseline, then every 12 months|Intent to treat (ITT) patient population||Percent Change from Baseline||Standard Error|Mean
729940|NCT00391625|Primary|Evaluation of Long Term Safety|Overall Summary of Treatment-emergent Adverse Events-Safety Population|Up to 84 months|ITT patient population||Participants|||Number
729941|NCT00392288|Secondary|Change From Baseline in Use of Albuterol/Salbutamol at Week 12.|Change in albuterol/salbutamol use from baseline to week 12|Baseline and Week 12|Analyses are based on children of the ITT population. It includes all randomized patients who have a baseline and a valid post-randomization lung function measurement.||Puffs per day||Standard Error|Least Squares Mean
729942|NCT00392288|Secondary|Change From Baseline in Total Daily Asthma Symptom Score at Week 12.|Change in total daily asthma symptom score from baseline to week 12. 5-Point, ordinal scale specifying patient's experience of symptoms during day and night from 0 (no symptoms) to 4 (symptoms that prevent the patient from engaging in daily activities or sleep)|Baseline and Week 12|Analyses are based on children of the ITT population. It includes all randomized patients who have a baseline and a valid post-randomization lung function measurement.||Scores on a scale||Standard Error|Least Squares Mean
729943|NCT00392288|Primary|Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Week 12.|Change in FEV1 (Percent of predicted) from baseline to week 12. FEV1 was measured only in children between 6 to <12 years only. Least Squares Mean were adjusted for Baseline FEV1, age [yrs], pooled center, previous corticosteroid therapy and holding chamber.|Baseline and Week 12|Analyses are based on children of the ITT population. It includes all randomized patients who have a baseline and a valid post-randomization lung function measurement. The primary analysis was restricted to an age range between 6 and <12 years.||Percent of predicted FEV1||Standard Error|Least Squares Mean
729944|NCT00392379|Secondary|Prolonged Smokeless Tobacco Abstinence at 6 Months|Participants had to have self-reported not having used any tobacco from 2 weeks after the target quit date to 6 months after baseline (22 weeks).|6 months|||Participants|||Number
729945|NCT00392379|Secondary|Self-reported Point Prevalence All Tobacco Abstinence at 3 Months|Participants had to have self-reported not having used any tobacco for the 7 days prior to the 3 month visit.|3 months|||Participants|||Number
729946|NCT00392379|Primary|Prolonged Smokeless Tobacco Abstinence at 3 Months|Participants had to have self-reported not having used any tobacco from two weeks past the target quit date to the 3-months post baseline.|3 months|ITT||Participants|||Number
729947|NCT00392392|Primary|Pathologic Complete Response Rate (PCRR), the Percentage of Patients Who Have No Evidence of Cancer in the Breast or Lymph Nodes Following Surgery|Pathologic complete response was defined as the absence of residual invasive cancer in the breast (pT0) and axillary lymph nodes (pN0).|18 months|Two patients refused surgery after completing six cycles of pre-operative (neoadjuvant) therapy.||percentage of participants|||Number
729948|NCT00392444|Primary|Objective Response (Partial and Complete) Per RECIST|Number of patients who had objective responses after radiology review|Up to 3 years|1 cancelled patient and 4 ineligible patients were excluded from analysis.||participants|||Number
729949|NCT00392496|Primary|Objective Tumor Response|It is defined as per the Report of the International workshop to standardize response criteria for non-Hodgkin’s lymphoma and reviewed independently|Up to 3 years|patients evaluable for response||participants|||Number
729950|NCT00392665|Secondary|Number of Participants With Toxicities According to Severity|Toxicities by Grades 1 or 2 and Grades 3 or 4 in each arm. Grade 4 = life-threatening, Grade 3 = serious, Grade 2 = moderate, Grade 1 = Mild|2 years|||Participants|||Count of Participants
729951|NCT00392665|Secondary|Duration of Overall Survival|Median overall survival (OS), determined by the Kaplan-Meier method.|2 years|||months||95% Confidence Interval|Median
729952|NCT00392665|Secondary|Overall Response Rate (ORR)|"Overall response rate (complete plus partial response=ORR), as determined by RECIST.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|2 years|Two of eighteen patients in both arms had radiographic partial responses, for an overall response rate of 11% for both arms, (95% CI 1.2%, 34.7%). The identical results below are not typos or placeholder values.||percentage of participants||95% Confidence Interval|Number
729953|NCT00392665|Primary|Efficacy of Erlotinib Plus Bevacizumab (Arm A) or Erlotinib Plus Sulindac (Arm B) as Measured by Progression-free Survival.|The primary outcome will be measured by median progression-free survival (PFS), determined by the Kaplan-Meier method for both Arm A and Arm B. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|1 year|||months||95% Confidence Interval|Median
729954|NCT00392678|Secondary|Change in Insulin, C-peptide, Homeostasis Model [HOMA] Index|HOMA-IR was not calcuated due to potential confounding effect of salicylates to inhibit insulin clearance. Change in C-peptide from Baseline to Week 14 is in the data table below|Baseline, week 14|||C-peptide in nmol/l||95% Confidence Interval|Mean
729955|NCT00392678|Secondary|Safety and Tolerability of Salsalate Compared to Placebo as Assessed by Adverse Events.|See adverse event module for details.|14 weeks|||participants|||Number
729956|NCT00392678|Secondary|Response Rates for a Reduction in HbA1c for Obese vs Non-obese Participants|This aim was proposed for the TINSAL-T2D stage 2 trial and is separately reported.|14-26 week||||||
729957|NCT00392678|Secondary|Response Rates in Patients Initially Treated With Lifestyle Modification, Insulin Secretagogue, Metformin or Combination Therapy|This aim was proposed for the TINSAL-T2D stage 2 trial and is separately reported.|14-26 week||||||
729958|NCT00392678|Secondary|Need for Discontinuation of Study Medication|This aim was proposed for the TINSAL-T2D stage 2 trial and is separately reported.|14 week||||||
729961|NCT00392678|Secondary|Change in Insulin, C-peptide, Homeostasis Model [HOMA] Index|HOMA-IR was not calcuated due to potential confounding effect of salicylates to inhibit insulin clearance. Change in insulin from Baseline to Week 14 in data table below.|Baseline, week 14|||pmol/l||Inter-Quartile Range|Median
729962|NCT00392678|Secondary|Change in Lipids (Low-density Lipoprotein Cholesterol [LDL-C], Non-high-density Lipoprotein Cholesterol [Non-HDL-C], Triglycerides [TG], Total Cholesterol [TC], High-density Lipoprotein Cholesterol [HDL C], TC/HDL-C Ratio, and LDL-C/HDL-C Ratio)|LDL-C/HDL-C ratio not calculated|14 week|||mg/dl||95% Confidence Interval|Mean
729963|NCT00392678|Secondary|Response Rates for Reduction in Fasting Glucose of ≥20 mg/dl, a Reduction in HbA1c of ≥0.5%, and a Reduction in HbA1c of ≥0.8%|This was an aim proposed for the longer duration study and is reported under TINSAL-T2D stage 2.|14-26 week||||||
729964|NCT00392678|Secondary|Change From Baseline and Trends in Fasting Glucose Over Time||14 week|||mg/dl||95% Confidence Interval|Mean
729965|NCT00392678|Secondary|Change From Baseline to Either 14 or 26 Weeks, or Last HbA1c Measurement Prior to Rescue Therapy|see primary outcome|14 week|||% HbA1c||95% Confidence Interval|Mean
729966|NCT00392678|Primary|The Primary Outcome for the TINSAL-T2D Study is Change in HbA1c Level From Baseline to Week 14 (Stage 1) in the Intent-to-treat (ITT) Population With Last Observation Carried Forward.||14 week|||% (units of HbA1c)||95% Confidence Interval|Mean
729967|NCT00392704|Secondary|Overall Survival (OS)Probability, the Percentage of Patients Estimated to be Alive Two Years After Beginning Protocol Treatment|The Percentage of Patients Estimated to be Alive Two Years After Beginning Protocol Treatment|24 Months|||percentage of patients|||Number
729968|NCT00392704|Primary|Two-Year Progression Free Survival (PFS) Probability, the Percentage of Patients Estimated to be Alive Without Worsening of Their Disease Two Years After Beginning Protocol Treatment|The percentage of patients estimated to be alive 2 years after beginning protocol treatment|24 months|All participants in this study were assessed and included in the progression free survival analysis||percentage of participants|||Number
729969|NCT00392769|Primary|Overall Disease Control Rate|Overall disease control rate also called the Clinical Benefit Response (CBR) is defined as Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) evaluated within 8 weeks (CR or PR) and 12 weeks (SD) of initial treatment, using Bayesian design.|Overall disease control rate (CR + PR + SD) evaluated within 8 weeks (CR or PR) and 12 weeks (SD) of initial treatment.|There were ten inevaluable participants (completing less than 1 cycle).||percentage of participants|||Number
729970|NCT00392782|Secondary|Overall Survival|Number of patients who were deceased at 1 year post transplant.|1 Year|||Participants|||Number
729971|NCT00392782|Secondary|Transplant-related Mortality|Number of patients with treatment related death at 1 year post transplant.|1 Year|||Participants|||Number
729972|NCT00392782|Secondary|Incidence of Graft Failure|Number of patients with graft failure is defined by lack of neutrophil engraftment by 100 days after transplant in patients surviving a minimum of 14 days.|Day 100|||Participants|||Number
729973|NCT00392782|Secondary|Incidence of Chronic Graft-versus-host Disease (GVHD)|"Number of patients with chronic graft-versus-host disease at 1 year post transplant. Graft-versus-host disease (GVHD) is a common complication of allogeneic bone marrow transplantation in which functional immune cells in the transplanted marrow recognize the recipient as foreign and mount an immunologic attack. Grade I=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening. Chronic GVHD is an extension of acute GVHD."|1 Year|||Participants|||Number
729974|NCT00392782|Secondary|Incidence of Grade II-IV Acute Graft-vs-host Disease (GVHD)|"Number of patients with grade II-IV acute graft-versus-host disease at Day 100 post transplant. Graft-versus-host disease (GVHD) is a common complication of allogeneic bone marrow transplantation in which functional immune cells in the transplanted marrow recognize the recipient as foreign and mount an immunologic attack. Grade I=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening."|Day 100|||Participants|||Number
729975|NCT00392782|Secondary|Incidence of Disease Relapse|Number of patients with disease at 1 year.|1 Year|||Participants|||Number
729976|NCT00392782|Primary|Incidence of Disease-free Survival|Number of patients alive and without disease at 1 year after transplant.|1 Year|||Participants|||Number
729977|NCT00392808|Primary|Serum Antibody Titers Against Haemophilus Influenzae Type b.||One year|||GMCs||95% Confidence Interval|Geometric Mean
729978|NCT00392808|Primary|Serum Bactericidal Activity Against MenC||One month after booster dose|||GMTs||95% Confidence Interval|Geometric Mean
729979|NCT00392821|Secondary|Progression-Free Survival.|Progression is Defined Using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% Increase in the Sum of the Longest Diameter of Target Lesions, or a Measurable Increase in a Non-target Lesion, or the Appearance of New Lesions.|18 months|||Months||95% Confidence Interval|Median
729980|NCT00392821|Primary|Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment||18 months|||percentage of evaluable patients||95% Confidence Interval|Number
729981|NCT00392834|Secondary|Correlation of EBV Load Measurements With OS, FFS, and EFS||baseline through 2 years post-treatment||||||
729982|NCT00392834|Secondary|Biologic and Prognostic Significance of Epstein-Barr Virus (EBV) at Diagnosis and Correlation With OS, FFS, and EFS||baseline through 2 years post-treatment||||||
729983|NCT00392834|Secondary|Degree of Disconcordance Between Flow Cytometry and CNS Cytology Results||baseline||||||
729984|NCT00392834|Secondary|Utility of Flow Cytometry in Detecting Leptomeningeal Disease||baseline and 6-8 weeks post-treatment||||||
729985|NCT00392834|Secondary|Correlation of C-flip Expression, p53 Mutations, and Multidrug Resistance Expression With OS, FFS, and EFS||baseline through 2 years post-treatment||||||
729986|NCT00392834|Secondary|Incidence of Infection-related Deaths||baseline through 2 years post-treatment||||||
729987|NCT00392834|Secondary|Toxicity||baseline through 2 years post-treatment||||||
729988|NCT00392834|Secondary|Event-free Survival (EFS)||6-8 weeks post treatment, every 4 months post-treatment for 2 years||||||
729989|NCT00392834|Secondary|Failure-free Survival (FFS)||6-8 weeks post treatment, every 4 months post-treatment for 2 years||||||
729990|NCT00392834|Secondary|Complete Response Rate||6-8 weeks post treatment, every 4 months post-treatment for 2 years||||||
729991|NCT00392834|Primary|Overall Survival (OS) at 1 Year||1 year post treatment|||Cumulative proportion surviving at 1 yr||95% Confidence Interval|Number
729992|NCT00392860|Primary|Change in Functional Status Score|The Functional Status Scale, which measures hand and wrist symptoms.|Baseline, 4 Months|Zero participants were analyzed because only 4 participants were enrolled in this trial. Analyzing the results would not result in any meaningful information. The manufacturer of the PalmRim decided not to pursue the design and development of the product. As a result, the PalmRim experiment arm did not enroll any participants.|||||
729993|NCT00392925|Secondary|Number of Participants With Treatment-emergent Anti-Leptin Antibodies by Week 4, Week 8, Week 12, Week 16 - Intent to Treat Population|Serum titer determinations for antibodies to leptin were made using a validated electrochemical luminescence (ECLA) bridging assay. Antibody titers were assessed according to the following dilutions: 0, 5, 25, 125, 625, 3125, 15625, and 78125. Participants were considered to have a positive titer to treatment-emergent antibodies to leptin at a given visit if they had a titer >=5 following a negative or missing titer at baseline or if they had a titer that had increased by at least 2 dilutions from a detectable level at baseline. All participants were evaluated (including those who did not receive metreleptin as their randomized study drug). Baseline was Day 1 (randomization).|Baseline up to Week 16|The Intent-To-Treat (ITT) Population includes all randomized participants who received at least 1 injection of any component of the randomized study medication; n=number with non-missing data at visit in each treatment group.||participants|||Number
729994|NCT00392925|Secondary|Number of Participants With Clinically Significant Abnormal ECG at Weeks 16, 20, or Early Termination - Randomized Population|A 12-Lead electrocardiogram (ECG) was obtained at Week -4, Day 1, Week 16, Week 20 or early termination and the overall interpretation of the ECG was made by the investigator as normal, abnormal (not clinically significant) and abnormal (clinically significant). The ECG consisted of the PR interval = time from beginning of the P wave to the beginning of the QRS complex; (Note: QRS complex is a name for the combination of 3 of the graphical deflections seen in an ECG); QRS (time from the beginning to the end of the QRS complex) interval; QT interval (measure between Q wave and T wave in the heart's electrical cycle); and QT interval corrected for heart rate using Fridericia's formula (QTcF) were measured in milliseconds (msec). .|Weeks 16, 20, early termination|All participants who were enrolled and randomized and had ECGs performed at Weeks 16, 20, or early termination. n=number of participants with ECGs at visit by treatment group.||participants|||Number
729995|NCT00392925|Secondary|Number of Hematology and Urinalysis Values of Potential Clinical Importance - Enrolled Population|Number of laboratory values of potential clinical importance (not participants) observed. Criteria for laboratory values of potential clinical importance for obese and overweight (BMI >= 25 kg/m^2) participants: Platelets high (H) >500,000/µL; low (L) <75,000/µL. Hematocrit males <36%, females <30%. Hemoglobin males <12 g/dL, females <10 g/dL. White blood cell count (WBC) H >18,000/µL; L <1,500/µL. Urine protein H >= 3+ or >= 500 mg/dL. Urine glucose H >= 3+ or >= 500 mg/dL. Urine ketones >= 3+ or Large. Time frame of evaluation differs depending on randomization status.|Enrollment up to Week 20(Randomized Group) or Enrollment up to, not including Day 1(Non-Randomized Group)|The Enrolled Population includes all enrolled participants who received at least 1 dose of pramlintide during the 4-week lead-in period or who had nonmissing vital signs data at Week -4. n=number with non-missing data in each treatment group||participants|||Number
729996|NCT00392925|Secondary|Number of Chemistry Values of Potential Clinical Importance - Enrolled Population|Number of values (not participants). Greater than (>), Less than (<), high (H), low (L). Criteria for laboratory values of potential clinical importance for obese and overweight (BMI>=25 kg/m^2) participants: Total bilirubin H > 2 mg/dL; glucose fasting or non-fasting H >200 mg/dL, L <60 mg/dL; Albumin L <2.5 g/dL; Creatine Phosphokinase (CPK) H >3*Upper limit of Normal (ULN); Sodium L<130 milliequivalents per liter (mEq/L), H >150 mEq/L; potassium L<3.0 mEq/L, H>5.5 mEq/L;bicarbonate L<18 mEq/L, H>35 mEq/L;calcium L <8 mg/dL, H>11 mg/dL; triglycerides H>500 mg/dL; Cholesterol L < 100 mg/dL, H > 350 mg/dL; Alkaline phosphatase H >3*ULN; Gamma-glutamyltransferase (GGT) H>3*ULN; creatinine males >1.6 mg/dL, females >1.4 mg/dL; alanine aminotransferase (ALT) H >3*ULN; aspartate aminotransferase (AST) H >3*ULN; urea nitrogen H >45 mg/dL; uric acid males >10.0 mg/dL, females > 8.0 mg/dL; Phosphorus L <1.0 mg/dL H >6.0 mg/dL. Time frame differs depending on randomization status.|Enrollment up to Week 20(Randomized Group) or Enrollment up to, not including Day 1(Non-Randomized Group)|The Enrolled Population includes all enrolled participants who received at least 1 dose of pramlintide during the 4-week lead-in period or who had nonmissing data at Week -4. n=number with non-missing data in each treatment group who were in the analysis.||laboratory values|||Number
729997|NCT00392925|Secondary|Absolute Change From Enrollment to Week -2, Week 16 and Week 20 in Heart Rate - Enrolled Population|Enrollment was Visit 2 (Week -4). Heart rate was measured after the participant rested for 5 minutes and was sitting. Heart Rate was measured in beats per minute (bpm). Vital signs were taken at each visit (screening, Week -4, Week -2, Day 1, Weeks 4, 8, 12, 16, 20 (or early termination). After the Lead-In Period, participants were either randomized to one of the 3 arms of the study or they were dropped from the study so the time frame for evaluation of all participants in the study was either: enrollment up to Week 20 for Randomized participants or enrollment up to, but not including Day 1 for Non-Randomized participants who participated only in the Lead-In Period.|Enrollment up to Week 20(Randomized Group) or Enrollment up to, not including Day 1(Non-Randomized Group)|ITT: those randomized, received at least 1 injection of any component of the randomized medication. Enrolled not randomized: those who received at least 1 dose of pramlintide in 4-week lead-in period. n=number with non-missing data at visit in each treatment group.||beats/min||Standard Deviation|Mean
729998|NCT00392925|Secondary|Mean Absolute Change From Enrollment to Week -2, Week 16 and Week 20 in Systolic and Diastolic Blood Pressure - Enrolled Population|Enrollment was Visit 2 (Week -4). Blood pressure (BP) was measured after 5 minutes of quiet rest with the participant in a sitting position and was measured in millimeters of mercury (mm Hg). Blood pressure was taken at each visit (screening, Week -4, Week -2, Day 1, Weeks 4, 8, 12, 16, 20 (or early termination). After the Lead-In Period, participants were either randomized to one of the 3 arms of the study or they were dropped from the study so the time frame for evaluation of all participants in the study was either: enrollment up to Week 20 for Randomized participants or enrollment up to, but not including Day 1 for Non-Randomized participants who participated only in the Lead-In Period.|Enrollment up to Week 20(Randomized Group) or Enrollment up to, not including Day 1(Non-Randomized Group)|ITT:those randomized, received at least 1 injection of any component of the randomized medication. Enrolled not randomized: those who received at least 1 dose of pramlintide in 4-week lead-in period. n=number with non-missing data at visit in each treatment group.||mm Hg||Standard Deviation|Mean
729999|NCT00392925|Secondary|LS Mean Absolute Change From Enrollment to Week 16 in Hospital Anxiety and Depression Scale (HADS) - Evaluable Population|The HADS is a questionnaire that uses 14 items to assess both anxiety and depression over the past week. The odd numbered items constitute the anxiety subscale, and the even numbered items constitute the depression subscale. The individual response scores for each subscale component are added together to obtain the individual subscale scores. The minimum and maximum score for each subscale is 0 and 21, respectively. The lower the score the more improvement a participant shows.|Enrollment to Week 16|Evaluable: randomized participants with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with the protocol (per sponsor). Those excluded from Evaluable were identified prior to unblinding. Number with non-missing data in each treatment group were analyzed (n).||units on a scale||Standard Error|Least Squares Mean
730000|NCT00392925|Secondary|LS Mean Absolute Change From Enrollment to Week 16 in Patient Reported Outcomes (PRO) for Eating Behavior - Evaluable Population|Enrollment was Visit 2 (Week -4). PRO for eating behavior: Binge Eating Scale (BES) Total Score (16-item questionnaire assessed the behavioral and cognitive correlates of binge eating, including participants' perceived self-control over eating behavior using a range of 1 to 4 with 1=positive perceptions and 4= negative perceptions. Minimum and maximum scores were 0 and 55, respectively); Susceptibility to Eating Questionnaire (SEQ) Total Score (measure of appetite, satiety, and perceived control over portion size using 10 VAS items with each response measured on a 100 mm visual analogue scale [ranges vary from Never to Very Often; Not at All Difficult to Extremely Difficult; Not at all Strong to Very Strong]. Responses to these items rated over the past 7 days;|Enrollment to Week 16|Evaluable: randomized participants with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with the protocol (per sponsor). Those excluded from Evaluable were identified prior to unblinding. n=number with non-missing data at visit in each treatment group.||units on a scale||Standard Error|Least Squares Mean
730001|NCT00392925|Secondary|LS Mean Absolute Change From Enrollment to Week 16 in Patient Reported Outcome (PRO) Instruments Measuring Quality of Life and Mood - Evaluable Population|Enrollment was Visit 2 (Week -4). PRO: Total Score in Impact of Weight on Quality of Life Questionnaire-lite Version (IWQOL-Lite), 31-item instrument used to assess the effect of weight on physical function, self-esteem, sexual life, public distress, and work. Individual items range from 1 to 5 with 5=always true and 1= never true. Total score measured on scale from 0 (worst) to 100 (best). Higher scores indicate improvement; Profile of Mood States (POMS), 65 mood adjectives that assess participants' mood over the past seven days. The POMS-B is an authorized, 30-item brief version of the POMS consisting of five items for each: Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment. Scores range from 0= Not at All to 4=Extremely. Factor scores added for total score. Lower score indicates improvement. 0=best outcome; 120=worst outcome.|Enrollment to Week 16|Evaluable: randomized participants with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with the protocol (per sponsor). Those excluded from Evaluable were identified prior to unblinding. n=number with non-missing data at visit in each treatment group. (POMS)n=19, 38, 36; (IWQOL-Lite)n=19, 38, 36||units on a scale||Standard Error|Least Squares Mean
730002|NCT00392925|Secondary|Mean Absolute Change From Enrollment to Baseline and Week 16 in Fasting Total Insulin - Evaluable Population|Enrollment was Visit 2 (Week -4). Baseline refers to Visit 4 (Day 1 of randomization period). Total insulin was measured in micro international units per milliliter (µIU/mL)|Enrollment to Week 16|Evaluable: randomized participants with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with the protocol (per sponsor). Those excluded from Evaluable were identified prior to unblinding. n=number with non-missing data at visit in each treatment group.||µIU/mL||Standard Deviation|Mean
730003|NCT00392925|Secondary|Mean Absolute Change From Enrollment to Baseline and Week 16 in Fasting Total Amylin -Evaluable Population|Enrollment was Visit 2 (Week -4). Baseline refers to Visit 4 (Day 1 of randomization period). Fasting total plasma amylin (peptide produced by beta cells in the pancreas) concentration was measured in picomolar (pM) and samples were obtained at screening, enrollment, baseline, Week 4 and Week 16.|Enrollment to Week 16|Evaluable: randomized participants with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with the protocol (per sponsor). Those excluded from Evaluable were identified prior to unblinding. n=number analyzed with non-missing data at visit.||pM||Standard Deviation|Mean
730004|NCT00392925|Secondary|Mean Absolute Change From Enrollment to Baseline, Weeks 4 and 16 in Fasting Total Leptin Concentration - Evaluable Population|Enrollment was Visit 2 (Week -4). Baseline refers to Visit 4 (Day 1 of randomization period). Leptin was measured in nanograms per milliliter (ng/mL). Plasma total leptin (including endogenous leptin and exogenous metreleptin) concentrations were measured using a validated sandwich-type immunoenzymetric assay utilizing polyclonal capture antibody, monoclonal detection antibody, and colorimetric readout by Amylin Pharmaceuticals, Inc. This assay is not specific for metreleptin and detects both endogenous leptin and exogenous recombinant-methionyl human leptin [metreleptin]).|Enrollment to Week 16|Evaluable: randomized participants with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with the protocol (per sponsor). Those excluded from Evaluable were identified prior to unblinding. n=number with non-missing data at visit in each treatment group.||ng/mL||Standard Deviation|Mean
730005|NCT00392925|Secondary|Mean Absolute Change From Enrollment to Week 16 in Fasting Glucose and Lipids - Evaluable Population|Enrollment was Visit 2 (Week -4). Baseline refers to Visit 4 (Day 1 of randomization period). Fasting Lipids included: total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, and Triglycerides. Fasting Glucose and Lipids were measured in milligrams per deciliter (mg/dL).|Enrollment to Week 16|Evaluable: randomized participants with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with the protocol (per sponsor). Those excluded from Evaluable were identified prior to unblinding. n=number with non-missing data for lipids and glucose in each treatment group.||mg/dL||Standard Deviation|Mean
730025|NCT00393042|Secondary|ADHD Parent Rating Scale-IV|Measures the severity of Total ADHD symptoms, Inattention and Hyperactivity/Impulsive symptoms. The Inattention and Hyperactivity/Impulsive symptoms can range from 0 to 27 each, with a higher score reflecting more severe ADHD symptoms. The total score is calculated by summing the inattention and Hyperactivity/Impulsive subscales. The total score can range from 0 to 54 with a higher score reflecting more severe ADHD symptoms.|completed weekly over 8-10 weeks|||units on a scale||Standard Deviation|Mean
730006|NCT00392925|Secondary|Number of Participants With BMI Change From Enrollment to Week 20 - Evaluable Population|BMI was measured as kilogram per meter of height squared (kg/m^2). Enrollment was Visit 2 (Week -4). Participants who were obese (BMI of 30 kg/m^2 to <35 kg/m^2) at enrollment were evaluated at Week 20 to see if the same number who were obese at enrollment were still obese at Week 20 or if they had changed to an BMI of overweight (BMI of 25 kg/m^2 to <30 kg/m^2) or a BMI of normal (BMI of <25 kg/m^2) or a greater obesity (BMI >35 kg/m^2). Participants who were overweight (BMI of 25 kg/m^2 to <30 kg/m^2) at enrollment were evaluated at Week 20 to see if the same number who were overweight at enrollment were still overweight at Week 20 or if they had changed to normal (or obese).|Enrollment up to Week 20|Evaluable: randomized participants with at least 1 dose of any treatment; completed Week 20 procedures and adequately complied with the protocol (per sponsor). Those excluded from Evaluable were identified prior to unblinding. Number analyzed were those participants with non-missing BMI data at enrollment and Week 20.||participants|||Number
730007|NCT00392925|Secondary|Number of Participants With BMI Change From Enrollment to Week 16 - Evaluable Population|BMI was measured as kilogram per meter of height squared (kg/m^2). Enrollment was Visit 2 (Week -4). Participants who were obese (BMI of 30 kg/m^2 to <35 kg/m^2) at enrollment were evaluated at Week 16 to see if the same number who were obese at enrollment were still obese at Week 16 or if they had changed to an BMI of overweight (BMI of 25 kg/m^2 to <30 kg/m^2) or a BMI of normal (BMI of <25 kg/m^2) or a greater obesity (BMI >35 kg/m^2). Participants who were overweight (BMI of 25 kg/m^2 to <30 kg/m^2) at enrollment were evaluated at Week 16 to see if the same number who were overweight at enrollment were still overweight at Week 16 or if they had changed to normal (or obese).|Enrollment up to Week 16|Evaluable: randomized participants with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with the protocol (per sponsor). Those excluded from Evaluable were identified prior to unblinding. Number analyzed were those participants with non-missing BMI data at enrollment and Week 16.||participants|||Number
730008|NCT00392925|Secondary|LS Mean Absolute Change in Hip Circumference From Screening up to Week 20 - Evaluable Population|Screening (Week -5 or -6) was the first visit for a participant. This first visit determined participant eligibility and occurred prior to enrollment (Week -4). Hip circumference was measured in centimeters (cm).|Screening up to Week 20|Evaluable: randomized participants with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with the protocol as per the sponsor. Those excluded from the Evaluable Population were identified prior to the unblinding process. Number with non-missing anthropometric data in each treatment group were analyzed.||cm||Standard Error|Least Squares Mean
730009|NCT00392925|Secondary|LS Mean Absolute Change in Waist Circumference From Baseline to Weeks 4, 8, 12, 16, 20 - Evaluable Population|Baseline was Visit 4 (Day 1 of randomization period). Waist circumference was measured in centimeters (cm).|Baseline to Week 20|Evaluable: randomized participants with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with the protocol (per sponsor). Those excluded from Evaluable were identified prior to unblinding. n=number with non-missing anthropometric data at visit in each treatment group.||cm||Standard Error|Least Squares Mean
730010|NCT00392925|Secondary|LS Mean Absolute Change in Waist Circumference From Enrollment to Weeks 4, 8, 12, 16, 20 - Evaluable Population|Waist circumference was measured in centimeters (cm). Least Squares mean = LS mean. Enrollment was Visit 2 (Week -4) which was the start of the 4 week Lead-In Period. At Day 1, the participant was randomized to one of the 3 study arms and the participant was treated up to Week 20.|Enrollment to Week 20|Evaluable: randomized participants with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with the protocol (per sponsor). Those excluded from Evaluable were identified prior to unblinding. n=number with non-missing anthropometric data at visit in each treatment group.||cm||Standard Error|Least Squares Mean
730011|NCT00392925|Secondary|LS Mean Percent Change in Weight From Enrollment to Baseline and LS Mean Percent Change in Excess Weight From Enrollment to Baseline - Evaluable Population|Excess body weight: the difference between a participant’s actual body weight and the weight a participant of his/her height would have if his/her BMI were 24.9 kg/m2. Excess body weight at a given visit was calculated as body weight in kilograms (kg) at that visit minus 24.9 × height in meters (m)^2 or 0, whichever was greater. If a participant achieved a normal BMI (24.9 kg/m^2), that subject was considered to have no excess weight. Additional weight loss that occurred after a normal BMI was achieved was not included in the calculation of excess weight loss. Enrollment was Visit 2 (Week -4), the start of the Lead-In Period. Baseline was Day 1 of the randomization to a study arm.|Enrollment to Baseline|Evaluable: randomized with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with protocol (per sponsor). Those excluded were identified prior to the unblinding process. Number with non-missing body weight data at Day 1 of Randomization were analyzed.||percentage of change||Standard Error|Least Squares Mean
730012|NCT00392925|Secondary|Number of Participants Achieving at Least 5% and at Least 10% Body Weight Loss From Baseline to Weeks 16 and 20, and Number of Participants With Sustained Weight Loss in Each Category - Evaluable Population|Baseline refers to Visit 4 (Day 1 of randomization period). Number of participants with 5% or more and 10% or more change in weight from baseline at each visit. Number of participants with 5% or more change in weight that was sustained through Week 16. Number of participants with 10% or more change in weight that was sustained through Week 20.|Baseline to Weeks 16 and Weeks 20|Evaluable: randomized with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with protocol (per sponsor). Those excluded were identified prior to the unblinding process. n=number with non-missing body weight data (at visit) in each treatment group.||participants|||Number
730013|NCT00392925|Secondary|Initial, Late, and Overall Rates of LS Mean Absolute Change in Body Weight From Day 1 to Week 20 - Evaluable Population|Initial (Day 1 through Week 12), late (Week 12 through Week 20), and overall (Day 1 through Week 20) rates of Least squares (LS) mean absolute change in body weight were defined by the slopes of the regression lines fitted to the observed body weights during the periods from Baseline (Day 1) through each visit to Week 20. Initial, late and overall absolute change was measured in kilograms of body weight per week (kg/week). Baseline refers to Visit 4 (Day 1 of randomization period).|Baseline to Week 20|Evaluable: randomized with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with protocol (per sponsor). Those excluded were identified prior to the unblinding process.||kg/week||Standard Error|Least Squares Mean
730014|NCT00392925|Secondary|LS Mean Percent Change in Body Weight From Enrollment to Weeks 4, 8, 12, 16, and 20 - Evaluable Population|Least Squares (LS) mean percent change is percentage that body weight changed over time at each visit. Enrollment was Visit 2 (Week -4) which was the start of the Lead-In Period. After the 4 week Lead-In Period, at Day 1, the participant was randomized to one of the 3 study arms and treated up to Week 20.|Enrollment to Week 20|Evaluable: randomized with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with protocol (per sponsor). Those excluded were identified prior to the unblinding process. n=number with non-missing body weight data (at visit) in each treatment group.||percentage of change||Standard Error|Least Squares Mean
730015|NCT00392925|Secondary|LS Mean Absolute Change in Body Weight From Enrollment to Weeks 4, 8, 12, 16, and 20 - Evaluable Population|Least Squares (LS) mean change in body weight as measured in kilograms (kg) from enrollment to each study visit. Enrollment was Visit 2 (Week -4) which was the start of the Lead-In Period. After the 4 week Lead-In Period, at Day 1, the participant was randomized to one of the 3 study arms and the participant was treated as per that arm up to Week 20.|Enrollment to Week 20|Evaluable: randomized with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with protocol (per sponsor). Those excluded were identified prior to the unblinding process. n=number with non-missing body weight data (at visit) in each treatment group.||kg||Standard Error|Least Squares Mean
730016|NCT00392925|Secondary|LS Mean Absolute Change From Baseline to Weeks 4, 8, 12, 20 in Body Weight - Evaluable Population|Least Squares (LS) mean absolute change in body weight as measured in kilograms (kg) from baseline to Weeks 4, 8, 12, 20. Baseline defined as Day 1 of randomized treatment|Baseline to Week 20|Evaluable: randomized with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with protocol (per sponsor). Those excluded were identified prior to the unblinding process. n=number with non-missing body weight data (at visit) in each treatment group.||kg||Standard Error|Least Squares Mean
730017|NCT00392925|Secondary|LS Mean Percent Change in Body Weight From Baseline to Weeks 4, 8, 12, 16, and 20 - Evaluable Population|Least Squares (LS) mean percent change in body weight from baseline to Weeks 4 through 20. Baseline defined as Day 1 of randomized treatment.|Baseline up to Week 20|Evaluable: randomized with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with protocol (per sponsor). Those excluded were identified prior to the unblinding process. n=number with non-missing body weight data (at visit) in each treatment group.||percentage of change||Standard Error|Least Squares Mean
730018|NCT00392925|Primary|Mean Absolute Change From Baseline to Week 16 in Body Weight - Evaluable Population|Absolute change in body weight as measured in kilograms (kg) from baseline to Week 16. Baseline defined as Day 1 of randomized treatment.|Baseline to Week 16|Evaluable: randomized participants with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with the protocol as per the sponsor. Participants excluded from the Evaluable Population were identified prior to the unblinding process. n=number with non-missing body weight data at Week 16 in each treatment group.||kg||Standard Error|Least Squares Mean
730019|NCT00393029|Secondary|In Vivo Survival of T-cell Receptor (TCR) Gene-engineered Cells in Participants|Survival of TCR gene-engineered cells is defined as >10% murine TCR positive cells.|3-12 months|||participants|||Number
730020|NCT00393029|Primary|The Number of Participants With Adverse Events|Here are the total number of participants with adverse events. Adverse events were described using the Common Terminology Criteria for Adverse Events (CTCAE) version 3. For the detailed list of adverse events see the adverse event module.|events related to all components of the treatment regimen were reported from the start of the non-myeloablative conditioning regiment through 30 days following treatment or resolution.|||participants|||Number
730021|NCT00393029|Primary|Clinical Tumor Regression|"Response Evaluation Criteria In Solid Tumors (RECIST).
See the protocol Link module for full criteria if desired."|1-11 months|||Participants|||Number
730022|NCT00393042|Secondary|Weiss Functional Impairment Rating Scale (WFIRS)|The WFIRS consists of 50 questions where respondents are asked to rate their child's functional impairment. The items of the WFIRS are scored on a four point Likert-type rating scale: 0 (never or not at all), 1 (sometimes or somewhat), 2 (often or much) or 3 (very often or very much) and aggregated to produce six domain scores: Family (ranges between 0-24), Learning or School (ranges between 0-33), Self-Concept (ranges between 0-15), Social Activities (ranges between 0-27), Life Skills (ranges between 0-36), and Risky Activities (ranges between 0-42). The subscales are scored by summing the responses in the subsection. The Total score is the sum of all the responses and it ranges between 0-150. The higher the score in each of the subscales the more impairment is recorded, this is also true for the total score.|8-10 weeks|The number of participants analyzed differs from the participant flow in all of the groups besides the Adderall XR - 10mg group because the WFIRS was not completed for every participant.||units on a scale||Standard Deviation|Mean
730023|NCT00393042|Secondary|Clinical Global Impression - Severity|The CGI-S scale summarizes the clinician's impression of the participant's symptom severity and ranges from 1-7 with 1 representing normal (not at all ill) and 7 representing extremely ill.|8-10 weeks|The number of participants analyzed differs from the participant flow in the Focalin XR groups because the CGI-S was not completed for every participant. The same is true for the Adderall XR - 25/30mg group.||units on a scale||Standard Deviation|Mean
730024|NCT00393042|Secondary|Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms|Three variations of the DAT 1 gene were observed, the 9/9 allele, the 9/10 allele and the 10/10 allele. The ADHD Rating Scale (ADHD-RS) and Clinical Global Impressions - Severity (CGI-S) measures were used to evaluate how the DAT 1 gene allele type altered the efficacy of the medication. The DAT 1 genotype did not predict differential response to Focalin XR or Adderall XR so the dose levels of each drug was combined to examine how the genotype interacted with the dose level. The ADHD-RS evaluates the severity of the participant's ADHD symptoms and includes two subscales: Inattention and Hyperactivity/Impulsivity. Both subscale scores range from 0 to 27 with a higher score representing more severe symptoms. The subscales are summed to calculate the total score which can range from 0 to 54. The CGI-S scale summarizes the clinician's impression of the participant's symptom severity and ranges from 1-7 with 1 representing normal (not at all ill) and 7 representing extremely ill.|8-10 weeks|The number of participants analyzed differs from the participant flow because some participants refused to provide a DNA sample for analysis or some participants did not have the allele type that was being observed. Of those that provided a DNA sample, 6 had the 9/9 allele on the DAT 1 gene, 15 had the 9/10 allele and 30 had the 10/10 allele.||units on a scale||Standard Deviation|Mean
730026|NCT00393042|Primary|Sleep Duration|Actigraphs (AW64 series) were worn each night and were used to assess participant's sleep patterns in their natural home environment. These computerized wristwatch-like devices collect data generated by movements. They are minimally invasive and allow sleep to be recorded reliably without interfering with the family's routine. One-minute epochs were used to analyze actigraphic sleep sata. Bedtimes and wake times were reported for each participant using sleep logs, and these times were used as the start and end times for the analyses. For each 1-min epoch, the total sum of activity counts were computed. If they exceeded a threshold (threshold sensitivity value = mean score in active period/45), then the epoch was considered waking. If it fell below that threshold, then it was considered sleep.The data for Adderall XR and Focalin XR was combined to look at the cumulative effects that medication has on sleep.|8-10 weeks|participants with sufficient sleep actigraphy data for analysis (n=37)||minutes||Standard Deviation|Mean
730027|NCT00393042|Primary|Sleep Start Time, and End Time as Determined by Actigraph and Sleep Diary Over 8 Weeks.|Actigraphs (AW64 series) were worn each night and were used to assess participant's sleep patterns in their natural home environment. These computerized wristwatch-like devices collect data generated by movements. They are minimally invasive and allow sleep to be recorded reliably without interfering with the family's routine. One-minute epochs were used to analyze actigraphic sleep sata. Bedtimes and wake times were reported for each participant using sleep logs, and these times were used as the start and end times for the analyses. For each 1-min epoch, the total sum of activity counts were computed. If they exceeded a threshold (threshold sensitivity value = mean score in active period/45), then the epoch was considered waking. If it fell below that threshold, then it was considered sleep. The data for Adderall XR and Focalin XR was combined to look at the cumulative effects that medication has on sleep.|8-10 weeks|Subjects with complete and valid actigraphy (n = 37) and sleep diaries were used to calculate sleep onset latency and sleep duration.||HHMM.SS||Standard Deviation|Mean
730028|NCT00393068|Secondary|Overall Survival||32 months||||||
730029|NCT00393068|Secondary|Progression-Free Survival||32 months||||||
730030|NCT00393068|Primary|Pathologic Complete Response (pCR) Rate||18 months|||participants|||Number
730031|NCT00393094|Primary|Radiographic Response Rate (Glioblastoma Multiforme Participants)|Definition of response: complete response (CR) is the complete disappearance of all measurable and evaluable disease. Partial response (PR) is greater than or equal to a 50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable lesions. Stable/No response (SD, NR)does not qualify for CR, PR, or progression. Progression is a 25% increase in the sum of products of all measurable lesions (or two target lesions if too numerous over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline.|23 months (date of first enrollment to 1 month after last progression)|||Percent of participants|||Number
730032|NCT00393094|Primary|Radiographic Response Rate (Anaplastic Glioma Participants)|Definition of response: complete response (CR) is the complete disappearance of all measurable and evaluable disease. Partial response (PR) is greater than or equal to a 50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable lesions. Stable/No response (SD, NR)does not qualify for CR, PR, or progression. Progression is a 25% increase in the sum of products of all measurable lesions (or two target lesions if too numerous over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline.|23 months (date of first enrollment to 1 month after last progression)|Analysis is per protocol (N=30), excluding the 1 patient who progressed and withdrew consent prior to any treatment but after enrollment.||Percent of participants|||Number
730033|NCT00393094|Primary|Number of Participants With Toxicity as Measured by The National Cancer Institute (NCI) Common Toxicity Criteria v. 3.0.|Here is the number of participants with any toxicity, defined as any adverse events possibly, probably or definitely related to the investigational drugs. For the detailed list of investigational new drug (IND)-related toxicities and other serious adverse events, see the adverse event module.|23 months (date of first enrollment to 1 month after last progression)|Analysis is per protocol (N=30), excluding the 1 patient who progressed and withdrew consent prior to any treatment but after enrollment.||Participants|||Number
730034|NCT00393094|Primary|Radiographic Response Rate (Malignant Glioma Participants)|Definition of response: complete response (CR) is the complete disappearance of all measurable and evaluable disease. Partial response (PR) is greater than or equal to a 50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable lesions. Stable/No response (SD, NR)does not qualify for CR, PR, or progression. Progression is a 25% increase in the sum of products of all measurable lesions (or two target lesions if too numerous over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline.|23 months (date of first enrollment to 1 month after last progression)|Analysis is per protocol (N=30), excluding the 1 patient who progressed and withdrew consent prior to any treatment but after enrollment.||Percent of participants|||Number
730035|NCT00393367|Secondary|Serious Adverse Events|Serious Adverse Events|0-5 days|89 of the 91 patients randomized to BIS were available for follow-up. 85 of the 89 patients randomized to placebo were available.||participants|||Number
730036|NCT00393367|Secondary|Number of Participants With Adverse Events (Non-serious).||within 30 days of the ED visit|Of the 180 patients randomized, 91 were to BIS, 89 were to placebo. Two patients were lost to follow-up in the BIS group and 4 in the placebo group.||Participants|||Number
730037|NCT00393367|Primary|Mean Change in Asthma Score at 2 Hours|The scale used is the Asthma Score published by Qureshi et al. The Asthma Score ranges from a low of 5 to maximum of 15 points. One to 3 points are given for each of 5 categories: age-based respiratory rate, oxygen saturation, wheeze, retractions, and dyspnea. For category detalails, please see the Qureshi reference. Scores of 5-7 are considered mild, 8-11 moderate, and 12-15 severe. Asthma Scores are recorded prior to any intervention and at 2 hours after budesonide inhalation suspension/albuterol intervention or saline placebo/albuterol comparator.|Initial asthma score minus score 2 hours after budesonide/albuterol intervention or saline placebo/albuterol comparator|88 of the 91 patients randomized to budesonide were evaluable for the primary outcome (1 was discharged home, 1 had no 2 hour score, and 1 did not have a valid initial score). 81 of the 89 patients randomized to placebo were evaluable (1 inadvertently received standard therapy, 2 withdrew, and 5 were admitted before a 2 hour score evaluation).||Units on a scale||95% Confidence Interval|Mean
730336|NCT00387647|Secondary|Overall Survival (OS)|The secondary efficacy variable is overall survival measured as time to death, which is the time from remission until death from any cause.|48 months|All participants||months||95% Confidence Interval|Median
730038|NCT00393367|Secondary|Relapse / Readmission Numbers.|Participants admitted to the hospital within 5 days of the ED visit|within 5 days of ED visit|89 of the 91 patients randomized to BIS were available for follow-up. 85 of the 89 patients randomized to placebo were available.||Participants|||Number
730039|NCT00393367|Secondary|Number of Subjects Moving From the Severe Asthma to Mild Asthma Category|Of the patients who presented in the severe asthma category (Asthma Severity score of 12-15), those who moved to the mild category (Asthma Severity score 5-7) 2 hours after the budesonide/albuterol intervention or saline/albuterol comparator.|From the initial score to 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator|Number of patients who presented in the severe asthma category (Asthma Score 12-15) who moved to the moderate asthma category (Asthma Score 8-11) 2 hours after either the intervention with budesonide/albuterol or saline/albuterol comparator.||Participants|||Number
730040|NCT00393367|Secondary|Number of Subjects Moving From the Severe Asthma to Moderate Asthma Category|Of the patients who presented in the severe asthma category (Asthma Severity score of 12-15), those who moved to the moderate category (Asthma Severity score 8-11) 2 hours after the budesonide/albuterol intervention or saline/albuterol comparator.|From the initial score to 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator|Number of patients who presented in the severe asthma category (Asthma Score 12-15) who moved to the moderate asthma category (Asthma Score 8-11) 2 hours after either the intervention with budesonide/albuterol or saline/albuterol comparator.||Participants|||Number
730041|NCT00393367|Secondary|Number of Subjects Remaining in the Severe Asthma Category|Of the patients who presented in the severe asthma category (Asthma Severity score of 12-15), those who remained in this category 2 hours after the budesonide/albuterol intervention or saline/albuterol comparator.|From the initial score to 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator|Number of patients who presented in the severe asthma category (Asthma Score 12-15) who remained in that category 2 hours after either the intervention with budesonide/albuterol or saline/albuterol comparator.||Participants|||Number
730042|NCT00393367|Secondary|Oxygen Saturation.|Mean oxygen saturation (non-invasive pulse-oximetry, % hemoglobin saturation) 2 hours after treatment with either budesonide/albuterol or saline/albuterol comparator minus mean oxygen saturation before treatment.|2 hours after treatment with either budesonide/albuterol or saline/albuterol comparator|||Percent Hemoglobin Saturation||95% Confidence Interval|Mean
730043|NCT00393367|Secondary|Mean Change in Respiratory Rate.|Mean respiratory rate in breaths per minute before treatment minus respiratory rate 2 hours after treatment with either budesonide/albuterol or saline/albuterol comparator.|Initial rate, minus rate taken 2 hours after budesonide/albuterol intervention or saline/albuterol comparator|||Breaths per minute||95% Confidence Interval|Mean
730044|NCT00393367|Secondary|Change in Mean Heart Rate|Mean of heart rate in beats per minute before treatment minus mean of heart rate 2 hours after treatment with either budesonide/albuterol or saline/albuterol|From the initial heart rate to heart rate 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator|||Beats per minute||95% Confidence Interval|Mean
730045|NCT00393367|Secondary|Number of Patients Hospitalized|The number of patients requiring hospital admission 4 hours after budesonide/albuterol intervention or saline/albuterol comparator. All hospitalization decisions are made at the discretion of the attending physician.|within 4 hours after the budesonide/albuterol intervention or saline/albuterol placebo|||Participants|||Number
730046|NCT00393367|Primary|Median Change in Asthma Score 2 Hours After Intervention|The scale used is the Asthma Score published by Qureshi et al. The Asthma Score ranges from a low of 5 to maximum of 15 points. One to 3 points are given for each of 5 categories: age-based respiratory rate, oxygen saturation, wheeze, retractions, and dyspnea. For category detalails, please see the Qureshi reference. Scores of 5-7 are considered mild, 8-11 moderate, and 12-15 severe. Asthma Scores are recorded prior to any intervention and at 2 hours after budesonide inhalation suspension/albuterol intervention or saline placebo/albuterol comparator.|Initial asthma score minus score 2 hours after budesonide/albuterol intervention or saline placebo/albuterol comparator|88 of the 91 patients randomized to budesonide were evaluable for the primary outcome (1 was discharged home, 1 had no 2 hour score, and 1 did not have a valid initial score). 81 of the 89 patients randomized to placebo were evaluable (1 inadvertently received standard therapy, 2 withdrew, and 5 were admitted before a 2 hour score evaluation).||Units on a scale||Full Range|Median
730047|NCT00393380|Secondary|Disease-free Survival|Disease-free survival|Measured at 1 year|13 patients were transplanted.||percentage of participants||95% Confidence Interval|Number
730048|NCT00393380|Secondary|Overall Survival|Overall Survival|Measured at 2 years|13 patients were transplanted.||percentage of participants||95% Confidence Interval|Number
730049|NCT00393380|Secondary|Cumulative Incidence of Relapse|Cumulative Incidence of Relapse|Measured at 2 years|13 patients were transplanted.||percentage of participants||95% Confidence Interval|Number
730050|NCT00393380|Secondary|100-day Transplant-related Mortality|100-day transplant-related mortality|Measured at Day 100|13 patients were transplanted||participants|||Number
730051|NCT00393380|Secondary|Platelet Engraftment (Greater Than 20,000)|Platelet engraftment (greater than 20,000)|Measured at Day 180|13 patients were transplanted.||percentage of participants||95% Confidence Interval|Number
730052|NCT00393380|Secondary|Cumulative Incidence of Chronic GVHD|Cumulative Incidence of Chronic GVHD|Measured at 2 years|13 patients were transplanted.||percentage of participants||95% Confidence Interval|Number
730053|NCT00393380|Secondary|Cumulative Incidence of Acute GVHD Grades II-IV at Day 100|Cumulative Incidence of Acute GVHD Grades II-IV at day 100|Measured at Day 100|13 patients were transplanted||percentage of participants||95% Confidence Interval|Number
730054|NCT00393380|Primary|Median Time to Neutrophil Engraftment (Defined as an Absolute Neutrophil Count [ANC] Greater Than 500)|Median time to neutrophil engraftment (defined as an absolute neutrophil count [ANC] greater than 500)|Statistic is calculated at Day 42 but ANC counts are measured daily up through discharge.|13 patients received the transplant.||days||Full Range|Median
730068|NCT00393484|Secondary|Mean Log10 Reduction From Baseline in Hepatitis B Virus (HBV) DNA at Weeks 24, 48, 96, 144, 192, and 240|Mean log10 reduction from Baseline in HBV DNA virus by the Roche Comprehensive Bio-Analytical System Amplicor polymerase chain reaction (PCR) assay at Week 24. The extent of the decrease was estimated by comparing HBV DNA levels of all participants in each group with a linear regression model with covariates of treatment and baseline HBV DNA by PCR assay.|At Weeks 24, 48, 96, 144, 192, and 240|Randomized participants who received at least 1 dose of study drug||log10 copies/mL||Standard Deviation|Mean
730055|NCT00393458|Secondary|Percentage of Days of Poor Control During 52 Weeks of Treatment|Percentage of days of poor control was defined as the number of days in the patient diary with a score ≥ 2 (scale of 0-3, a higher number means more severe symptoms) for at least 2 of 5 symptoms (cough, wheeze, production of sputum, color of sputum, breathlessness) over 52 weeks divided by the number of evaluable days (days with ≥ 2 symptoms with scores). The analysis included baseline percentage of days of poor control, FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|Baseline to end of study (Week 52)|Modified intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug, excluding patients from a number of centers.||Percentage of days||Standard Error|Least Squares Mean
730056|NCT00393458|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 + 1 Day, Day 85|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|Week 12 + 1 day, Day 85|Modified intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug, excluding patients from a number of centers.||Liters||Standard Error|Least Squares Mean
730057|NCT00393484|Secondary|Number of Participants With Grade 3 or 4 Abnormalities in Laboratory Test Results by World Health Organization (WHO) Criteria at Week 96|ULN=upper limit of normal; ALT=alanine transaminase. WHO criteria: Grade 3=Severe (inability to carry out usual activity); Grade 4=Very severe (debilitating or significantly incapacitating patient despite symptomatic treatment).|Start of dosing (Day 1) until Week 96|Randomized participants who received at least 1 dose of study drug and who were evaluable.||Participants|||Number
730058|NCT00393484|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Most Common AEs, and Grade 3/4 AEs at Week 240|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|Start of dosing (Day 1) until end of treatment (Week 240) + 5 days|Participants who were randomized and received at least 1 dose of study drug||Participants|||Number
730059|NCT00393484|Secondary|Number of Participants With Viral Rebound and Drug-resistant Hepatitis B Virus (HBV) DNA Mutations at Week 96|Virologic rebound was defined as a confirmed ≥1 log10 increase in HBV DNA from nadir on blinded treatment (as determined by 2 sequential HBV DNA values or last on-treatment measurement).|At 96 weeks|All participants who received study drug and who had samples of measureable HBV DNA values||Participants|||Number
730060|NCT00393484|Secondary|Percentage of Participants With a Virologic Response as Defined by Undetectable Hepatitis B Virus DNA at Weeks 48, 96, 144, 192, and 240|Undetectable HBV DNA= <300 copies/mL by polymerase chain reaction assay|At Weeks 48, 96, 144, 192, and 240|Randomized participants who received at least 1 dose of study drug||Percetage of participants|||Number
730061|NCT00393484|Secondary|Number of Participants With Virologic Rebound at Week 24|Virologic rebound was defined as a confirmed ≥1 log10 increase in hepatitis B virus (HBV) DNA from nadir on blinded treatment (as determined by 2 sequential HBV DNA measurements or last on-treatment measurement).|At Week 24|||Participants|||Number
730062|NCT00393484|Secondary|Number of Participants With Clinically or Statistically Significant Changes in Vital Sign Measurements at Week 24|Vital signs assessed included blood pressure, heart rate, body temperature, and respiration rate.|Start of dosing (Day 1) until end of treatment (Week 24) + 5 days and to end of 24-week follow-up period|Randomized participants who received at least 1 dose of study drug||Participants|||Number
730063|NCT00393484|Secondary|Number of Participants With Grade 3 or 4 Abnormalities in Laboratory Test Results by World Health Organization (WHO) Criteria at Week 24|ULN=upper limit of normal; ALT=alanine transaminase. WHO criteria: Grade 3=Severe (inability to carry out usual activity); Grade 4=Very severe (debilitating or significantly incapacitating patient despite symptomatic treatment).|Start of dosing (Day 1) until end of treatment (Week 24) + 5 days and to the end of the 24-week follow-up period|Randomized participants who received at least 1 dose of study drug||Participants|||Number
730064|NCT00393484|Secondary|Number of Participants With Elevations in Alanine Transaminase (ALT) and Aspartate Aminoaminase (AST) Levels, Elevations in ALT and AST Levels,Simultaneous Elevations in ALT and Total Bilirubin Levels, and ALT Flares at Week 24|ALT flares=ALT>2*Baseline and 10*upper limit of normal. Serious adverse events/deaths reported for enrolled patients regardless of treatment status.|Start of dosing (Day 1) until end of treatment (24 weeks) + 5 days and to end of 24-week follow-up period|Randomized participants who received at least 1 dose of study drug||Participants|||Number
730065|NCT00393484|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Most Common AEs, and Grade 3/4 AEs at Week 24|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Most common AEs=AEs affecting ≥3 participants. Grade 3 (Severe)/Grade 4 (Very Severe)AEs per World Health Organization (WHO) criteria.Serious adverse events/deaths reported for enrolled patients regardless of treatment status.|Start of dosing (Day 1) until end of treatment (Week 24) + 5 days and to end of 24-week follow-up period|Treated cohort: includes participants who are randomized and received at least 1 dose of study drug (ETV or LVD).||Participants|||Number
730066|NCT00393484|Secondary|Number of Participants With Normalization of Serum Alanine Aminotransferase (ALT) Levels at Weeks 24, 48, and 96|Normalization of serum ALT= ≤*institutional upper limit of normal.|At Weeks 24, 48, and 96|Randomized participants who received at least 1 dose of study drug||Participants|||Number
730067|NCT00393484|Secondary|Mean Laboratory Test Values for Alanine Aminotransferase (ALT) at Week 24|Mean ALT values from baseline by laboratory test. .|At Week 24|Randomized participants who received at least 1 dose of study drug||U/L||Standard Deviation|Mean
730069|NCT00393484|Secondary|Number of Participants With Hepatitis B Virus (HBV) DNA <10^3, <10^4, or < 10^5 Copies/mL by Polymerase Chain Reaction (PCR) Assy at Weeks 24, 48, and 96|The number and percentage of participants achieving the following endpoints will be tabulated at each visit through Week 240 by treatment group: HBV DNA <300 copies/mL by PCR assay; HBV DNA <10^3, <10^4, or < 10^5 copies/mL by PCR assay. Treatment comparisons will be assessed using the same method as the primary endpoint.|At Weeks 24, 48, and 96|Randomized participants who received at least 1 dose of study drug||Participants|||Number
730070|NCT00393484|Primary|Percentage of Participants Who Achieved a Virologic Response at Week 24|Virologic response=Hepatitis B virus DNA <300 copies/mL by polymerase chain reaction assay.|At Week 24|Randomized participants who received at least 1 dose of study drug||Percentage of participants|||Number
730071|NCT00393510|Secondary|Time of Ulcer Healing|Time taken for maturation of granulation to enable skin grafting.|24 week|||Weeks||Standard Deviation|Mean
730072|NCT00393510|Secondary|Tumour Necrosis Factor-alpha Levels in Serum|The state of inflammation at baseline and at 4 weeks after treatment. TNF-alpha are in value of serum level.|Baseline and 4 week|||pg/mL||Standard Deviation|Mean
730073|NCT00393510|Primary|Number of Participants With Limb Salvage|The number of successful limb rescued (without amputation).|24 weeks|||Participants|||Number
730074|NCT00393523|Other Pre-specified|Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of ENGERIX-B in Infancy|Geometric Mean Titer (GMT) for all subjects who completed a 3-dose primary vaccination series of ENGERIX-B™ and who received a booster dose of either modified process hepatitis B vaccine or ENGERIX-B™|4 weeks after vaccination with either modified process hepatitis B vaccine or ENGERIX-B|Per-protocol population (defined as the subjects that completed the study as defined by the protocol). Subjects were excluded from the analysis population mainly because they did not receive the primary series vaccination series as defined in the protocol or the study vaccine was not maintained at proper temperature as defined in the protocol.||mIU/mL||95% Confidence Interval|Geometric Mean
730075|NCT00393523|Other Pre-specified|Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of RECOMBIVAX HB in Infancy|Geometric Mean Titer (GMT) for all subjects who completed a 3-dose primary vaccination series of RECOMBIVAX HB™ and who received a booster dose of either modified process hepatitis B vaccine or ENGERIX-B™|4 weeks after vaccination with either modified process hepatitis B vaccine or ENGERIX-B|Per-protocol population (defined as the subjects that completed the study as defined by the protocol). Subjects were excluded from the analysis population mainly because they did not receive the primary series vaccination series as defined in the protocol or the study vaccine was not maintained at proper temperature as defined in the protocol.||mIU/mL||95% Confidence Interval|Geometric Mean
730076|NCT00393523|Secondary|Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of ENGERIX-B in Infancy|Number of subjects who received a 3-dose primary series of ENGERIX-B ™ in infancy and who demonstrated antibodies to hepatitis B surface antigen ≥10 mIU/mL at 4 weeks after receiving a booster dose of modified process hepatitis B vaccine or ENGERIX-B™.|4 weeks after vaccination with either modified process hepatitis B vaccine or ENGERIX-B|Per-protocol population (defined as the subjects that completed the study as defined by the protocol). Subjects were excluded from the analysis population mainly because they did not receive the primary series vaccination series as defined in the protocol or the study vaccine was not maintained at proper temperature as defined in the protocol.||Participants|||Number
730077|NCT00393523|Primary|Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of RECOMBIVAX HB in Infancy|Number of subjects who received a 3-dose primary series of RECOMBIVAX HB™ in infancy and who demonstrated antibodies to hepatitis B surface antigen ≥10 mIU/mL at 4 weeks after receiving a booster dose of modified process hepatitis B vaccine or ENGERIX-B™.|4 weeks after vaccination with either modified process hepatitis B vaccine or ENGERIX-B|Per-protocol population (defined as the subjects that completed the study as defined by the protocol). Subjects were excluded from the analysis population mainly because they did not receive the primary series vaccination series as defined in the protocol or the study vaccine was not maintained at proper temperature as defined in the protocol.||Participants|||Number
730078|NCT00393705|Secondary|Total Daily Insulin Dose at 4 Weeks and 12 Weeks||4 weeks and 12 weeks|Number of patients who received at least one dose of study drug and had a post-baseline insulin measurement at week 4 and week 12.||International Units (IU)||Standard Deviation|Mean
730079|NCT00393705|Secondary|Change From Baseline in Weight at 16 Week Endpoint||Baseline, 16 weeks|Number of patients who received at least one dose of study drug and had at least one post-baseline weight value at week 16.||kilograms (kg)||Standard Deviation|Mean
730080|NCT00393705|Secondary|30-Day Adjusted Rate of Hypoglycemic Events|Hypoglycemia: any time a patient feels, or another person observes, that patient is experiencing a sign/symptom that he or she would associate with hypoglycemia or a plasma-equivalent glucose measurement ≤70 mg/dL. Nocturnal hypoglycemia: hypoglycemia occurring after bedtime and prior to morning meal and morning dose of insulin or metformin. Severe hypoglycemia: hypoglycemia where patient requires assistance from another person and which is associated with either a blood glucose level less than 50 mg/dL or prompt recovery after oral carbohydrate, intravenous glucose or glucagon administration.|Baseline through 16 weeks|Number of patients who received at least one dose of study drug and had at least one assessment after randomization.||number of events per 30 days||Standard Deviation|Mean
730081|NCT00393705|Secondary|Number of Patients With Self-reported Hypoglycemic Episodes|Hypoglycemia: any time a patient feels, or another person observes, that patient is experiencing a sign/symptom that he or she would associate with hypoglycemia or a plasma-equivalent glucose measurement ≤70 mg/dL. Nocturnal hypoglycemia: hypoglycemia occurring after bedtime and prior to morning meal and morning dose of insulin or metformin. Severe hypoglycemia: hypoglycemia where patient requires assistance from another person and which is associated with either a blood glucose level less than 50 mg/dL or prompt recovery after oral carbohydrate, intravenous glucose or glucagon administration.|Baseline through 16 weeks|Number of patients who received at least one dose of study drug and had at least one assessment after randomization.||participants|||Number
730082|NCT00393705|Secondary|Mean Daily Blood Glucose Values at 16 Week Endpoint||16 weeks|Number of patients who received at least one dose of study drug and had a post-baseline blood glucose reading at week 16 for the respective variable.||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
730083|NCT00393705|Secondary|Mean 2-hour Postprandial Blood Glucose Excursions After Midday Meal at 16 Week Endpoint|Participants self-monitored their blood glucose concentrations at 7 time points: three premeal and three 2-hour postprandial meal measurements for the morning (breakfast), midday (lunch), and evening (dinner) meals, as well as a 3:00 AM measurement. Results presented here are for the difference (excursion) between midday premeal and 2-hour postprandial midday meal blood glucose concentrations at Week 16.|16 weeks|Number of patients who received at least one dose of study drug and had a post-baseline 2-hour postprandial blood glucose reading after the midday meal at week 16.||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
730084|NCT00393705|Secondary|2-hour Postprandial Plasma Glucose Concentrations After the Midday Meal From Self-monitored 7-point Plasma Glucose at 16 Week Endpoint|Participants self-monitored their blood glucose concentrations at 7 time points: three premeal and three 2-hour postprandial meal measurements for the morning (breakfast), midday (lunch), and evening (dinner) meals, as well as a 3:00 AM measurement. Results presented here are for the blood glucose concentrations 2-hours after the midday meal at Week 16.|16 weeks|Number of patients who received at least one dose of study drug and had a post-baseline 2-hour postprandial plasma glucose reading after the midday meal at week 16.||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
730085|NCT00393705|Secondary|Change From Baseline in Hemoglobin A1c (HbA1c) at 16 Week Endpoint||Baseline, 16 Weeks|Number of patients who received at least one dose of study drug and a post-baseline HbA1c value at endpoint.||percent HbA1c||Standard Deviation|Mean
730086|NCT00393705|Secondary|Percentage of Patients Achieving Hemoglobin A1c (HbA1c) <7% and HbA1c ≤6.5% at 16 Week Endpoint||16 weeks|Number of patients who received at least one dose of study drug and had a post-baseline HbA1c value at endpoint.||percentage of participants|||Number
730087|NCT00393705|Primary|Hemoglobin A1c (HbA1c) at 16 Week Endpoint||16 weeks|Number of patients who received at least one dose of study drug and had an HbA1c measure at endpoint.||percent HbA1c||Standard Deviation|Mean
730088|NCT00393718|Secondary|Hypoglycaemic Episodes|Hypoglycaemic episodes measured over 52 weeks of treatment. Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|over 52 weeks of treatment|Full Analysis Set (FAS) consists of all subjects who received at least one dose of study drug.||number of events per year of exposure|||Number
730089|NCT00393718|Secondary|Body Weight After 52 Weeks of Treatment||after 52 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.||kg||Standard Error|Least Squares Mean
730090|NCT00393718|Secondary|Body Weight After 24 Weeks of Treatment||after 24 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.||kg||Standard Error|Least Squares Mean
730091|NCT00393718|Secondary|Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 52 Weeks of Treatment|Mean postprandial plasma glucose (PG) increment in 7-point plasma glucose profile, ie the mean of the difference of plasma glucose measured before and after a meal, after 52 weeks of treatment. The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime.|after 52 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.||mg/dL||Standard Error|Least Squares Mean
730092|NCT00393718|Secondary|Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 24 Weeks of Treatment|Mean postprandial plasma glucose (PG) increment in 7-point plasma glucose profile, ie the mean of the difference of plasma glucose measured before and after a meal, after 24 weeks of treatment. The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime.|after 24 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.||mg/dL||Standard Error|Least Squares Mean
730093|NCT00393718|Secondary|Mean PG in 7-point Plasma Glucose Profile After 52 Weeks of Treatment|Mean plasma glucose(PG) in 7-point plasma glucose profile measured after 52 weeks of treatment. The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime.|after 52 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.||mg/dL||Standard Error|Least Squares Mean
730094|NCT00393718|Secondary|Mean PG in 7-point Plasma Glucose Profile After 24 Weeks of Treatment|Plasma glucose (PG) profile measured after 24 weeks of treatment. The time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime.|after 24 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.||mg/dL||Standard Error|Least Squares Mean
730095|NCT00393718|Secondary|Postprandial Glucose AUC After 52 Weeks of Treatment|Postprandial glucose AUC measured 0-3 hours after a meal after 52 weeks of treatment|after 52 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.||mg/dL *h||Standard Error|Least Squares Mean
730096|NCT00393718|Secondary|Postprandial Glucose AUC After 24 Weeks of Treatment|Postprandial glucose AUC measured 0-3 hours after a meal after 24 weeks of treatment|after 24 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.||mg/dL *h||Standard Error|Least Squares Mean
730097|NCT00393718|Secondary|Fasting Plasma Glucose After 52 Weeks of Treatment||after 52 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.||mg/dL||Standard Error|Least Squares Mean
730098|NCT00393718|Secondary|Fasting Plasma Glucose After 24 Weeks of Treatment||after 24 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.||mg/dL||Standard Error|Least Squares Mean
730099|NCT00393718|Secondary|Glycosylated Haemoglobin A1c (HbA1c) After 52 Weeks of Treatment||after 52 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.||percentage of total haemoglobin||Standard Error|Least Squares Mean
730100|NCT00393718|Primary|Glycosylated Haemoglobin A1c (HbA1c) After 24 Weeks of Treatment||after 24 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.||percentage of total haemoglobin||Standard Error|Least Squares Mean
730101|NCT00393796|Primary|Percentage of Participants That Experience Progression by 6 Months for Participants Receiving Sunitinib and Participants Receiving Placebo|"The primary endpoint of this unblinded, randomized trial is to compare the 6-month progression rate in patients randomized to maintenance SU011248 as compared with placebo following primary chemotherapy.
Progression is defined as a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions."|6 Months Post Treatment|||percentage of participants||95% Confidence Interval|Number
730102|NCT00393848|Secondary|Change in Maximal Voluntary Contraction||Baseline and 6 weeks post surgery|Measure not performed in Experiment 2||kg/kg leg lean mass||Standard Error|Mean
730103|NCT00393848|Primary|Muscle Protein Synthesis||Perioperative and discharge|||%/d||Standard Error|Mean
730104|NCT00393861|Secondary|Overall Survival|Will be examined using Kaplan-Meier estimates. Time until death or last evaluation will be calculated. If a patient did not die, they will be censored in the analysis.|completion of study, up to 5 years|All patients enrolled and received treatment.||months||95% Confidence Interval|Median
730105|NCT00393861|Secondary|Duration of Remission (CR + PR)|Will be examined using Kaplan-Meier estimates. Time from earliest confirmed remission criteria until death or progression will be calculated. If a patient continued to be in remission at the end of the study, they will be censored at their last evaluation in the analysis.|completion of study, up to 5 years|All patients enrolled and received treatment.||months||95% Confidence Interval|Median
730106|NCT00393861|Secondary|Objective Response Rate (Complete and Partial Response)|The percent of patients having an objective response (complete or partial response) will be estimated with a 90% exact binomial confidence interval for the percent of patients receiving drug per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|completion of study, up to 5 years|All patients enrolled and received treatment.||percentage of participants||90% Confidence Interval|Number
730107|NCT00393861|Primary|Twelve Month Disease-free Survival Rate|The percent of patients being disease-free at 12 months after treatment initiation will be estimated with a 90% exact binomial confidence interval for the percent of patients receiving drug.|12 month post completion of treatment|All patients enrolled and received treatment.||percentage of participants||90% Confidence Interval|Number
730108|NCT00393874|Primary|PSQI|"Self-report sleep quality measure. Scores range between 0 and 21, with higher scores reflecting poor sleep quality.
A score of < or = to 5 reflects good sleep quality."|Baseline, post, 4 months post-treatment|For the medication arm, 18 participants completed PSQI at screening, 14 at post, and 12 at follow-up. For the Behavioral arm, 17 participants completed ISI at screening, 13 at post, and 12 at follow-up. For the placebo arm, 15 participants completed ISI at screening, 13 at post, and 11 at follow-up.||units on a scale||Standard Deviation|Mean
730109|NCT00393874|Primary|PSG Composite Measure|"Sleep Efficiency (SE) is the ratio of total time spent asleep over total time spent in bed.
For PSG studies, (SE) typically vary between 50% and 95%. Greater values indicated more consolidated sleep."|Baseline sleep study and post sleep study|For the medication arm, 18 participants completed a PSG study at baseline and 13 completed a PSG post treatment. For the Behavioral arm, 17 participants completed a PSG at baseline and 12 completed a PSG post-treatment. For the placebo arm, 15 participants completed a PSG at baseline and 12 completed a PSG post-treatment.||percentage of time asleep vs time in bed||Standard Deviation|Mean
730110|NCT00393874|Primary|Sleep Diary Measures|"Sleep diary SE, nightmare frequency Sleep diary sleep efficiency can range from 0 to 100%, and typically varies between 50% and 95%. Higher % values reflect greater sleep consolidation, i.e., greater ratio of time asleep/time in bed.
Nightmare frequency varies between 0 and no upper limit is provided. Greater frequency of nightmares reflects greater nightmare severity."|baseline and post|For the medication arm, 15 participants completed the sleep diary (SD) at baseline and 13 returned a SD post treatment. For the Behavioral arm, 15 participants completed the SD at baseline, and 12 returned it at follow-up. For the placebo arm, 12 participants completed the diary at baseline and 10 returned one at follow-up.||units on a scale||Standard Deviation|Mean
730111|NCT00393874|Primary|Insomnia Severity Index|Self-report measures of insomnia severity. Scores range from 0 to 28, with higher scores indicated more severe insomnia. A score < 8 is considered to reflect no significant insomnia.|Screening, Post, and Follow-up|For the medication arm, 18 participants completed ISI at screening, 15 at post, and 12 at follow-up. For the Behavioral arm, 17 participants completed ISI at screening, 13 at post, and 12 at follow-up. For the placebo arm, 15 participants completed ISI at screening, 13 at post, and 11 at follow-up.||units on a scale||Standard Deviation|Mean
730112|NCT00393887|Primary|Number of Patients With Inguinal Hernia Recurrence||1 year|||participants|||Number
730125|NCT00394082|Secondary|Kaplan-Meier Estimates for Participant Survival|Participant survival is the time from the first dose of study drug to patient death from any cause. Patients that did not die were censored at the last known time the patient was alive.|up to 39 months|Treated population||months||95% Confidence Interval|Median
730113|NCT00393913|Primary|Vigilance|Vigilance is measured using the psychomotor vigilance task which is a portable reaction time test that is contained in a small, programmable, portable electronic box that requires only a single switch to start. The task consists of responding to a small bright red light stimulus by pressing a response button as soon as the stimulus appears. This stops the stimulus counter and displays the reaction time (RT) in milliseconds for a 2-second period and the task duration is 20 minutes. The subject is instructed to press the button as soon as each stimulus appears in order to keep the reaction time as low as possible. The PVT yields highly informative metrics on the capacity for sustained attention including the frequency of lapses (reaction time > 500 milliseconds). The higher the number of lapses the greater the impairment. Well rested (non-sleepy) subjects have almost no lapses(<2) during the 20min test.|Baseline, CPAP (4-6 weeks), CPAP withdrawal (2 nights)|Per protocol||Lapses||Standard Deviation|Mean
730114|NCT00393913|Primary|Objective Sleepiness|Multiple Sleep Latency Test (MSLT) measures the latency to sleep onset in minutes. The shorter the latency to sleep the more sleepy the subject.|Measured at baseline, on CPAP (4-6 weeks), CPAP withdrawal (2 nights)|||minutes||Standard Deviation|Mean
730115|NCT00393913|Primary|Subjective Sleepiness|Measured using the Epworth sleepiness scale (ESS). The Epworth sleepiness scale is used in the assessment of daytime sleepiness and measures the general level of sleepiness.The ESS presents the subject with eight situations and asks how likely they are to fall asleep (0= never, 1 =slight chance of dozing, 2= moderate chance of dozing and 3 =high chance of dozing) in these situations. The sum of the 8 answers is used as the score and ranges from 0 (not sleepy) to 24 (extremely sleepy), and a score of greater than 10 is an indication that a person may be excessively sleepy.|Baseline, CPAP( 4 -6 weeks), Off CPAP ( 2 nights)|||units on a scale||Standard Deviation|Mean
730116|NCT00393939|Secondary|Change From Baseline European Quality of Life 5-dimensional Self-Report Questionnaire (EQ-5D) Score|EQ-5D: standardized, participant-administered 2 part measure of health outcome. Part 1: descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), used 3 levels (no, some, extreme problems) and a single index value characterized current health status using formula that weighted the dimensions. Part 2: overall rating of participant's current health used Visual Analog Scale with endpoints labeled ‘best imaginable health state’ and ‘worst imaginable health state’. Change from baseline = score for Cycle/Day minus baseline score.|Baseline, every 6 weeks up to end of treatment or early termination (up to Month 33)|ITT population; data not analyzed because study failed its primary endpoint.||units on a scale||95% Confidence Interval|Mean
730117|NCT00393939|Secondary|Change From Baseline in EORTC-QLQ Breast Cancer Module (EORTC-QLQ-BR23) Score|EORTC-QLQ-BR23 measured multi-item functional scales for body image, sexual functioning, sexual enjoyment, and future perspective and measured single item symptoms scales which assessed systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss. For functional scales, scores ranged from 0 to 100 where higher scores represented a better level of functioning. For symptoms scales, scores ranged from 0 to 100 where higher scores represented a greater degree of symptoms. Change from baseline = score for Cycle/Day minus baseline score.|Baseline, every 6 weeks up to end of treatment or early termination (up to Month 33)|ITT population; data not analyzed because study failed its primary endpoint.||units on a scale||95% Confidence Interval|Mean
730118|NCT00393939|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionaire-C30 (EORTC- QLQ-C30) Score|EORTC QLQ-C30 measured 5 functional domains (physical, role, cognitive, emotional, and social), global health status, and symptom scales of fatigue, pain, nausea and vomiting, dyspnoea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties. For functional domains and global health status, scores ranged from 0 to 100 where higher scores represented a better level of functioning. For symptoms scales, scores ranged from 0 to 100 where higher scores represented a greater degree of symptoms. Change from baseline = score for Cycle/Day minus baseline score.|Baseline, every 6 weeks up to end of treatment or early termination (up to Month 33)|ITT population; data not analyzed because study failed its primary endpoint.||units on a scale||95% Confidence Interval|Mean
730119|NCT00393939|Secondary|Overall Survival (OS)|Time from randomization to date of death due to any cause. OS calculated as (Months) = (death date minus date of first dose of study medication plus 1) divided by 30.4. For participants who were alive, overall survival was censored at last contact.|Baseline to date of death from any cause (up to Month 33)|ITT population||months||95% Confidence Interval|Median
730120|NCT00393939|Secondary|Duration of Response (DR)|DR defined as time from first objective documentation of complete or partial response that was subsequently confirmed to first documentation of disease progression or to death due to any cause, whichever occurred first. DR calculated (Months) = (the date of the first documentation of objective tumor progression or death due to any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4.|Baseline up to Month 33|ITT population. Number of participants analyzed = number of participants with confirmed objective tumor response.||months||95% Confidence Interval|Median
730121|NCT00393939|Secondary|Percentage of Participants With Objective Response|Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as the disappearance of all tumor lesions (target and non-target). PR defined as greater than or equal to 30 percent (≥30%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions with a non-progressive disease status of the non-target lesions.|Baseline up to Month 33|ITT population||percentage of participants|||Number
730122|NCT00393939|Primary|Progression-Free Survival (PFS)|PFS defined as time from date of randomization to date of the first documentation of objective tumor progression or death due to any cause, whichever occurred first. PFS calculated as (Months) = (first event date minus randomization date plus 1) divided by 30.4.|Baseline up to Month 33|Intent-to-Treat (ITT) Population: all randomized participants||months||95% Confidence Interval|Median
730123|NCT00393978|Primary|Change in Percent Days of Cannabis Use Per Week|Change in percent days of cannabis use per week from baseline to week 16.|16 weeks|||cannabis use||Standard Deviation|Mean
730124|NCT00393978|Primary|Change in Joints Per Week|Change in timeline follow-back self-reported of joint equivalents per week from baseline to 16 weeks.|16 weeks|||joints||Standard Deviation|Mean
730159|NCT00394329|Secondary|Spirometry, Pre- and Post-bronchodilator||Measured during the 44-week treatment period||||||
730160|NCT00394329|Secondary|Albuterol Use||Measured during the 44-week treatment period||||||
730126|NCT00394082|Secondary|Kaplan-Meier Estimate for Duration of Response|"Duration of response is defined as progression-free survival in responders, i.e. as the time between the start of a complete response (CR) or partial response (PR) and the start of progressive disease (PD) or patient death from any cause, whichever occurred first. Patients that did not have progression or have not died were censored at the last known time the patient was progression free. Patients that initiate other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated.
Progressive disease is defined in outcome #2. Complete response (CR) and partial response (PR) are defined in outcome #3."|up to 39 months|Treated population of participants who had a response.||months||95% Confidence Interval|Median
730127|NCT00394082|Secondary|Percentage of Participants With Stable Disease for >= 16 Weeks, or Complete or Partial Response According to Response Evaluation Criteria in Solid Tumors (RECIST)|Disease control is stable disease (SD) for >=16 weeks + complete response (CR) + partial response (PR). RECIST defines SD as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease and no new lesions. Definitions for CR and PR can be found in outcome #3.|up to 39 months|Treated population||percentage of participants||95% Confidence Interval|Number
730128|NCT00394082|Secondary|Percentage of Participants With Objective Confirmed Complete or Partial Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST)|Objective response is complete response (CR) + partial response (PR). RECIST defines overall response of CR as the disappearance of all target and non-target lesions and no appearance of new lesions, confirmed at least 4 weeks after initial documentation. Overall response of PR is defined as >= 30% decrease from baseline in the sum of the longest diameters of target lesions and no progression of non-target lesions and no appearance of new lesions, confirmed at least 4 weeks after initial documentation. PR is also recorded when all measurable disease has completely disappeared, but a non-measurable component (i.e., ascites) is still present but not progressing and no appearance of new lesions. The objective response is determined by combining the response of target and non-target lesions and the appearance of new lesion(s) or not together.|up to 39 months|Treated population.||percentage of participants||95% Confidence Interval|Number
730129|NCT00394082|Primary|Kaplan-Meier Estimates for Progression-free Survival|"Progression-free survival is defined as the time from first dose of study drug to the start of disease progression or patient death, whichever occurs first. Patients who do not have disease progression or have not died at the end of follow-up were censored at the last known time the patient was progression free. Patients that initiate other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated.
Response Evaluation Criteria in Solid Tumors (RECIST) defines progressive disease (PD) as a >= 20% increase taking as reference the smallest sum of the longest diameters recorded since the treatment started; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion."|up to 39 months|Treated population.||months||95% Confidence Interval|Median
730130|NCT00394082|Primary|Participants With At Least One Treatment-Emergent Adverse Event (TEAE)|Count of study participants who had at least one treatment-emergent adverse event (TEAE) defined as any adverse event that began or worsened in grade after the start of study drug through 30 days after the last dose of study drug.|up to 25 months|Safety population||participants|||Number
730131|NCT00394095|Primary|Change in Body Weight|For all participants, change in body weight in kg over 12 weeks from Baseline to Week 12.|12 weeks|Bipolar youth (ages 12-17) who were taking olanzapine (10-20 mg/day) for a manic episode, were given topiramate (300-400mg/day) or comparable dose placebo for 12 weeks. Analysis was per protocol.||kg||95% Confidence Interval|Mean
730132|NCT00394095|Secondary|Tolerability of Topiramate|To examine the tolerability of topiramate in combination with olanzapine for the prevention of weight gain in youth with bipolar disorder.|12 weeks||||||
730133|NCT00394095|Primary|Change in Body Mass Index (BMI)|For all participants, BMI was computed using Change in BMI [kg/m2 (weight/height2)] over 12 weeks from Baseline to Week 12.|12 weeks|The analysis was per protocol based on change in BMI over 12 weeks in the Experimental sample (N=16) compared to the Placebo group (N=14).||kg/m2||95% Confidence Interval|Mean
730134|NCT00394212|Secondary|Subjects Achieving 20% Excess Weight Loss at 6 Months|%Excess Weight Loss (%EWL) is computed as: [(Weight at Baseline - Weight at 6 months)/(Weight at Baseline - Ideal Weight at BMI of 25)]*100|6 months|ITT, Last Observation Carried Forward||percentage of participants|||Number
730135|NCT00394212|Secondary|Subjects Achieving Weight Stabilization at 6 Months|Weight is stabilized if 6 month weight is +/- 2% from baseline weight.|6 months|ITT, Last Observation Carried Forward||percentage of participants|||Number
730136|NCT00394212|Secondary|Subjects Achieving 15% Excess Weight Loss (EWL)|%Excess Weight Loss (%EWL) is computed as:[(Weight at Baseline - Weight at 6 months)/(Weight at Baseline - Ideal Weight at BMI of 25)]*100.|6 months|ITT, Last Observation Carried Forward||percentage of participants|||Number
730137|NCT00394212|Primary|Weight Loss (%)|Percent Weight Loss is computed as [(Baseline weight - 6 mo. weight) / Baseline weight] * 100|6 months|ITT using Last Observation Carried Forward (LOCF)||percentage of weight lost||Standard Deviation|Mean
730138|NCT00394251|Primary|Participants With Treatment-Emergent Toxicities With a Frequency >=20% at 6 Months Post Chemotherapy|"Toxicities are summarized using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) terms. Participants with treatment-emergent toxicities with a frequency of >=20% in any treatment arm, and participants with at least one toxicity are reported.
Taxane subsets (ABI-007 subset and Taxol subset treatment arms) summarize participants with treatment-emergent toxicities defined as any AEs that begin or worsen in severity grade after the start of taxane treatment (cycle 5, week 9) through 30 days after the last dose of taxane (week 20) and were ongoing 6 months after chemotherapy (month 10).
Entire regiments (AC --> ABI-007 and AC --> Taxol treatment arms) summarize participants with treatment-emergent toxicities defined as any AEs that begin or worsen in severity grade after the start of chemotherapy (cycle 1, week 1) through 30 days after the last dose of chemotherapy (week 20) and were ongoing 6 months after chemotherapy (month 10)."|Month 10|Participants in the Treated Population for whom safety data was available 6 months post-chemotherapy||participants|||Number
730161|NCT00394329|Secondary|Asthma Control Days||Measured during the 44-week treatment period||||||
730162|NCT00394329|Primary|Participants Experiencing an Asthma Exacerbation That Requires Systemic Corticosteroid Therapy||Measured during the 44-week treatment period|All randomized participants were included in the time-to-event analysis||participants||95% Confidence Interval|Number
730139|NCT00394251|Secondary|Summary of Participants’ Most Severe Grade for Liver and Renal Function Laboratory Adverse Experiences During Study (All Treatment Cycles)|"Summary of the most severe grades using the National Cancer Institute’s Common Terminology Criteria for Adverse Events v3.0 (CTCAE) for the following liver and renal function tests.
Grade 0 = within normal range for all measurements.
Alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST):
Grade 1 = > upper limit of normal (ULN) – 2.5*ULN
Grade 2= >2.5-5.0*ULN
Grade 3= >5.0-20.0*ULN
Grade 4= >20.0*ULN
Bilirubin:
Grade 1= >ULN – 1.5*ULN
Grade 3= >3.0 – 10.0*ULN
Creatinine:
- Grade 1= >ULN – 1.5*ULN"|Week 1 up to week 50|Treated population with at least one post-treatment laboratory measure.||participants|||Number
730140|NCT00394251|Secondary|Change From Baseline in Percent Left Ventricular Ejection Fraction (% LVEF) at the Final Evaluation|Decreased left ventricular ejection fraction (LVEF) is an indication of cardiotoxicity. Change from baseline measurements to the final evaluation are summarized.|up to week 46|Participants in the treated population who had both baseline and one treatment measurement for %LVEF||percentage of healthy LVEF||Full Range|Median
730141|NCT00394251|Secondary|Myelosuppression During Taxane Dosing Cycles|"Myelosuppression represented by neutropenia (low absolute neutrophil counts (ANC)) with severity grades according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
Grade 1 = <lower limit of normal (LLN)-1.5*10^9/L
Grade 2 = <1.5 - 1.0*10^9/L
Grade 3 = <1.0 - 0.5*10^9/L
Grade 4 = <0.5*10^9/L
Values are reported across all severity grades without assessment of relationship to taxane treatment, and also by relation to taxane treatment as reported by investigators."|Weeks 9-16|Participants in the treated population who received at least 1 dose of taxane and had laboratory values.||participants|||Number
730142|NCT00394251|Secondary|Summary of Participant Treatment Exposure, Dose Interruptions, Dose Reductions, and Dose Delays|"Counts of participants who
completed the protocol-defined treatment cycles,
had a dose interruption
had a dose reduction
had a dose delay. A dose delay refers to the delay of all interventions in the cycle.
Dose modifications are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities.
Use of pegfilgrastim is included in the summary."|up to Week 46|Treated population||participants|||Number
730143|NCT00394251|Secondary|Percent of Protocol Taxane Dose|Percent of the protocol-defined taxane (ABI-007 or Taxol) dose that was actually taken by study participants.|approximately week 9-16|Participants in the treated population who received at least 1 dose of taxane.||percentage of protocol-defined taxane||Standard Deviation|Mean
730144|NCT00394251|Primary|Participants With Treatment-Emergent Toxicities With a Frequency >=20% at 3 Months Post Chemotherapy|"Toxicities are summarized using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) terms. Participants with treatment-emergent toxicities with a frequency of >=20% in any treatment arm, and participants with at least one toxicity are reported.
Taxane subsets (ABI-007 subset and Taxol subset treatment arms) summarize participants with treatment-emergent toxicities defined as any AEs that begin or worsen in severity grade after the start of taxane treatment (cycle 5, week 9) through 30 days after the last dose of taxane (week 20) and were ongoing 3 months after chemotherapy (month 7).
Entire regiments (AC --> ABI-007 and AC --> Taxol treatment arms) summarize participants with treatment-emergent toxicities defined as any AEs that begin or worsen in severity grade after the start of chemotherapy (cycle 1, week 1) through 30 days after the last dose of chemotherapy (week 20) and were ongoing 3 months after chemotherapy (month 7)."|Month 7|Participants in the Treated Population for whom safety data was available 3 months post-chemotherapy||participants|||Number
730145|NCT00394251|Secondary|Mean Taxane Dose Intensity Per Week|Cumulative taxane (ABI-007 or Taxol) dose divided by the number of weeks on taxane treatment.|approximately week 9-16|Participants in the treated population who received at least 1 dose of taxane.||mg/m^2/week||Standard Deviation|Mean
730146|NCT00394251|Secondary|The Cumulative Dose of Taxane Delivered During Study|The cumulative dose of taxane (Taxol or ABI-007) taken during the study (cycles 4-8 which is approximately weeks 9-16).|approximately week 9-16|Participants in the treated population who received at least 1 dose of taxane.||mg/m^2||Standard Deviation|Mean
730147|NCT00394277|Secondary|SVR-12 (Actual Treatment Period)|SVR-12 according to the actual treatment period was defined as the percentage of patients with undetectable HCV RNA at least 12 weeks after the last dose of study drug.|12 weeks after end of treatment|Intent-to-treat population (all patients treated with at least one dose of either study medication)||Percentage of patients|||Number
730148|NCT00394277|Secondary|SVR-12 (Scheduled Treatment Period)|SVR-12 according to the scheduled treatment period was defined as the percentage of patients with undetectable HCV RNA at 12 weeks after the scheduled treatment period (a single last HCV RNA PCR <15 IU/mL measured at or after week 60).|12 weeks after end of treatment|Intent-to-treat population (all patients treated with at least one dose of either study medication)||Percentage of patients|||Number
730149|NCT00394277|Secondary|SVR-24 (Actual Treatment Period)|SVR-24 according to the actual treatment period was defined as the percentage of patients with undetectable HCV RNA at least 20 weeks after the last dose of study drug.|24 weeks after end of treatment|Intent-to-treat population (all patients treated with at least one dose of either study medication)||Percentage of patients|||Number
730150|NCT00394277|Primary|Sustained Virological Response (SVR)-24 (Scheduled Treatment Period)|SVR-24 according to the scheduled treatment period was defined as the percentage of patients with undetectable HCV RNA at 24 weeks after completion of the treatment period (a single last HCV RNA PCR <15 IU/mL measured at or after week 68 (ie, on or after study day 477).|Week 72|Intent-to-treat population (all patients treated with at least one dose of either study medication)||Percentage of patients|||Number
730151|NCT00394329|Secondary|Adverse Events||Measured during the 44-week treatment period||||||
730152|NCT00394329|Secondary|Asthma Control Test||Measured during the 44-week treatment period||||||
730153|NCT00394329|Secondary|Asthma-specific Quality of Life Assessment||Measured during the 44-week treatment period||||||
730154|NCT00394329|Secondary|Exhaled Nitric Oxide||Measured during the 44-week treatment period||||||
730155|NCT00394329|Secondary|Methacholine Provocative Concentration at 20% (PC20)||Measured during the 44-week treatment period||||||
730156|NCT00394329|Secondary|Impulse Oscillometry||Measured during the 44-week treatment period||||||
730157|NCT00394329|Secondary|Peak Expiratory Flow Rate Variability||Measured during the 44-week treatment period||||||
730158|NCT00394329|Secondary|Morning (AM) and Evening (PM) Peak Expiratory Flow Rate||Measured during the 44-week treatment period||||||
730163|NCT00394355|Secondary|Summary of Change From Baseline to Endpoint in FEV1 (Forced Expiratory Volume in One Second).|Mean percent change from Baseline (the last non-missing value prior to treatment) in pulmonary function test FEV1 from in-office visits and at Endpoint (last non-missing postbaseline value carried forward)|Baseline and up to ~ one year of treatment|||percentage of FEV1||Standard Deviation|Mean
730164|NCT00394355|Secondary|Mean Percent Change in the Femoral Neck BMD From the Averaged Baseline Value to the Averaged Value at the Endpoint of Treatment Time Point|The averaged baseline value is the average of the two scan results prior to treatment. The endpoint of treatment time point is the average of the last two valid post baseline BMD scans during the treatment period carried forward.|Baseline and up to ~ one year of treatment|All randomized participants||percentage of BMD||Standard Deviation|Mean
730165|NCT00394355|Secondary|Mean Percent Change in the Left Total Femur From the Averaged Baseline Value to the Averaged Value at the Endpoint of Treatment Time Point|The averaged baseline value is the average of the two scan results prior to treatment. The endpoint of treatment time point is the average of the last two valid post baseline BMD scans during the treatment period carried forward.|Baseline and up to ~ one year of treatment|All randomized participants||percentage of BMD||Standard Deviation|Mean
730166|NCT00394355|Primary|Mean Percent Change in Lumbar Spine Bone Mineral Density (BMD) From the Averaged Baseline Value to the Endpoint of Treatment Time Point|The averaged baseline value is the average of the two scan results prior to treatment. The endpoint of treatment time point is the average of the last two valid post baseline BMD scans during the treatment period carried forward.|Baseline and up to ~ one year of treatment|All randomized participants||percentage of BMD||Standard Deviation|Mean
730167|NCT00394433|Secondary|Progression-Free Survival|Progression-free survival based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study or death. Patients alive and progression-free at last follow-up are censored. Per RECIST 1.0 criteria: progressive disease is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.|Disease was evaluated radiologically at baseline and every 2 cycles on treatment. Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 6 cycles/18 weeks given 3-week cycle length (range 1-26 cycles).|The analysis dataset is comprised of all enrolled patients.||months||95% Confidence Interval|Median
730168|NCT00394433|Secondary|Overall Survival|Overall survival is defined as the time from study entry to death or date last known alive and estimate using Kaplan-Meier (KM) methods.|Patients in the study cohort were followed for a median of 12.2 month (up to 40 months).|The analysis dataset is comprised of all enrolled patients.||months||95% Confidence Interval|Median
730169|NCT00394433|Secondary|Best Response|Best response on treatment was based on RECIST 1.0 criteria: Complete Response (CR) is complete disappearance of all target lesions; Partial Response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. Both require confirmation no fewer than 4 weeks apart. CR/PR assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. Progressive disease (PD) is at least a 20% increase in the sum of longest diameter of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions. Stable disease is defined as any condition not meeting above criteria.|Disease was evaluated radiologically at baseline and every 2 cycles on treatment. Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 6 cycles/18 weeks given 3-week cycle length (range 1-26 cycles).|The analysis dataset is comprised of all treated and evaluable patients.||participants|||Number
730170|NCT00394433|Primary|10-month Progression-Free Survival Rate|10-month progression-free survival rate is the probability of patients remaining alive and progression-free at 10-months from study entry estimated using Kaplan-Meier methods. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.|Disease was evaluated radiologically at baseline and every 2 cycles on treatment; Treatment continued until disease progression or unacceptable toxicity. Relevant for this endpoint was disease status at 10 months.|The analysis dataset is comprised of all enrolled patients.||probability (%)||95% Confidence Interval|Number
730171|NCT00394472|Secondary|Plasma Concentration (µmol/L) of AZD3355 Analysed From Blood Sample Taken in the Interval One to Two Hours After the First Intake of AZD3355 65 mg Capsule||An interval of one to two hours after the first intake of AZD3355 65 mg capsule|||μmol/L||Standard Deviation|Mean
730172|NCT00394472|Primary|Number of Participants With at Most One Day With Not More Than Mild Intensity of the Symptoms ‘a Burning Feeling Behind the Breastbone’ and ‘Unpleasant Movement of Material Upwards From the Stomach’ During the Last Seven Days of Treatment|Symptom intensity rated by participants twice daily on a six-graded Likert scale (Did not have; Very mild; Mild; Moderate; Moderately severe; Severe) using an electronic Reflux Disease Questionnaire (RDQ) diary|Twice daily during the last seven days on treatment|||Participants|||Number
730173|NCT00394524|Secondary|Mean Hospital Length of Stay in Days|mean number of days in the hospital|during the entire hospitalization|||days||Standard Deviation|Mean
730174|NCT00394524|Secondary|Length of Intensive Care Unit (ICU) Stay|average number of days in the intensive care unit|mean number of days in the ICU during the hospital stay|||days||Standard Deviation|Mean
730175|NCT00394524|Secondary|Differences Between Treatment Groups in Hypoglycemia||daily||||||
730176|NCT00394524|Primary|Mean Glucose|glucose in mg/dl assessed with inpatient calibrated glucometers|daily mean blood glucose during the insulin infusion|||mg/dl||Standard Deviation|Mean
730201|NCT00394654|Primary|Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 56|Change from baseline (percent reduction) in mean maximum decline of AUC of the participants FEV1 during LAR at 3 to 7 hours after an inhaled allergen challenge.|Day 56|All participants who were randomized into the study and completed the second allergen challenge on Day 7.||Percent||Standard Deviation|Mean
730177|NCT00394589|Primary|Change in Disease Activity Score Based on 28 Joint Count (DAS28) Score.|Descriptive summary of DAS28 (Disease Activity Score Based on 28 Joint Count)change from Baseline to the end of study (Week 24) in the population with available data at both Baseline and Week 24 (increased dose group, n=5; increased frequency group, n=7; and control group, n=5). DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value).|Between Screening (Week <=1) and Week 24|Intent-to-treat population; subjects with available data at both Baseline and Week 24||Score on a Scale||Standard Deviation|Mean
730178|NCT00394654|Secondary|Terminal Phase Volume of Distribution (Vz)|Vz of MEDI-528 in serum|Days 0, 6, 7, 27, 55, 84, and 126|All participants who were randomized and received any MEDI-528||Liter||Geometric Coefficient of Variation|Geometric Mean
730179|NCT00394654|Secondary|Total Body Clearance (CL)|CL of MEDI-528 in serum|Days 0, 6, 7, 27, 55, 84, and 126|All participants who were randomized and received any MEDI-528||Liter per day||Geometric Coefficient of Variation|Geometric Mean
730180|NCT00394654|Secondary|Terminal Phase Half-Life (T1/2)|T1/2 of MEDI-528 in nasal lavage|Days -6 to -1, 8, 29, and 57|All participants who were randomized, received any MEDI-528, and had nasal lavage samples obtained||Day||Geometric Coefficient of Variation|Geometric Mean
730181|NCT00394654|Secondary|Terminal Phase Half-Life (T1/2)|T1/2 of MEDI-528 in sputum|Days -21 to -7, 7, 28, and 56|All participants who were randomized, received any MEDI-528, and had sputum samples obtained||Day||Geometric Coefficient of Variation|Geometric Mean
730182|NCT00394654|Secondary|Terminal Phase Half-Life (T1/2)|T1/2 of MEDI-528 in serum|Days 0, 6, 7, 27, 55, 84, and 126|All participants who were randomized and received any MEDI-528||Day||Geometric Coefficient of Variation|Geometric Mean
730183|NCT00394654|Secondary|Percent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)]|AUC(ext) of MEDI-528 in nasal lavage|Days -6 to -1, 8, 29, and 57|All participants who were randomized, received any MEDI-528, and had nasal lavage samples obtained||Percent||Geometric Coefficient of Variation|Geometric Mean
730184|NCT00394654|Secondary|Percent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)]|AUC(ext) of MEDI-528 in sputum|Days -21 to -7, 7, 28, and 56|All participants who were randomized, received any MEDI-528, and had sputum samples obtained||Percent||Geometric Coefficient of Variation|Geometric Mean
730185|NCT00394654|Secondary|Percent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)]|AUC(ext) of MEDI-528 in serum|Days 0, 6, 7, 27, 55, 84, and 126|All participants who were randomized and received any MEDI-528||Percent||Geometric Coefficient of Variation|Geometric Mean
730186|NCT00394654|Secondary|Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)]|AUC(0-infinity) of MEDI-528 in nasal lavage|Days -6 to -1, 8, 29, and 57|All participants who were randomized, received any MEDI-528, and had nasal lavage samples obtained||Nanogram times day per milliliter||Geometric Coefficient of Variation|Geometric Mean
730187|NCT00394654|Secondary|Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)]|AUC(0-infinity) of MEDI-528 in sputum|Days -21 to -7, 7, 28, and 56|All participants who were randomized, received any MEDI-528, and had sputum samples obtained||Nanogram times day per milliliter||Geometric Coefficient of Variation|Geometric Mean
730188|NCT00394654|Secondary|Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)]|AUC(0-infinity) of MEDI-528 in serum|Days 0, 6, 7, 27, 55, 84, and 126|All participants who were randomized and received any MEDI-528||Microgram times day per milliliter||Geometric Coefficient of Variation|Geometric Mean
730189|NCT00394654|Secondary|Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)]|AUC(0-t) of MEDI-528 in nasal lavage|Days -6 to -1, 8, 29, and 57|All participants who were randomized and received any MEDI-528||Nanogram times day per milliliter||Geometric Coefficient of Variation|Geometric Mean
730190|NCT00394654|Secondary|Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)]|AUC(0-t) of MEDI-528 in sputum|Days -21 to -7, 7, 28, and 56|All participants who were randomized and received any MEDI-528||Nanogram times day per milliliter||Geometric Coefficient of Variation|Geometric Mean
730191|NCT00394654|Secondary|Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)]|AUC(0-t) of MEDI-528 in serum|Days 0, 6, 7, 27, 55, 84, and 126|All participants who were randomized and received any MEDI-528||Microgram times day per milliliter||Geometric Coefficient of Variation|Geometric Mean
730192|NCT00394654|Secondary|Observed Maximum Nasal Lavage Concentration (Cmax)|Cmax of MEDI-528 in nasal lavage|Days -6 to -1, 8, 29, and 57|All participants who were randomized and received any MEDI-528||Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
730193|NCT00394654|Secondary|Observed Maximum Sputum Concentration (Cmax)|Cmax of MEDI-528 in sputum|Days -21 to -7, 7, 28, and 56|All participants who were randomized and received any MEDI-528||Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
730194|NCT00394654|Secondary|Observed Maximum Serum Concentration (Cmax)|Cmax of MEDI-528 in serum|Days 0, 6, 7, 27, 55, 84, and 126|All participants who were randomized and received any MEDI-528||Microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
730195|NCT00394654|Secondary|Time to Observed Maximum Nasal Lavage Concentration (Tmax)|Tmax of MEDI-528 in nasal lavage|Days -6 to -1, 8, 29, and 57|All participants who were randomized and received any MEDI-528||Day||Geometric Coefficient of Variation|Geometric Mean
730196|NCT00394654|Secondary|Time to Observed Maximum Sputum Concentration (Tmax)|Tmax of MEDI-528 in sputum|Days -21 to -7, 7, 28, and 56|All participants who were randomized and received any MEDI-528||Day||Geometric Coefficient of Variation|Geometric Mean
730197|NCT00394654|Secondary|Time to Observed Maximum Serum Concentration (Tmax)|Tmax of MEDI-528 in serum|Days 0, 6, 7, 27, 55, 84, and 126|All participants who were randomized and received any MEDI-528||Day||Geometric Coefficient of Variation|Geometric Mean
730198|NCT00394654|Secondary|Incidence of Anti-drug Antibodies (ADA) to MEDI-528|Number of participants with ADA to MEDI-528|Days 0, 27, 55, 84, and 126|All subjects who received at least one dose of investigational product (MEDI-528 or placebo)||Participants|||Number
730199|NCT00394654|Secondary|Incidence of Serious Adverse Events|Number of participants experiencing serious adverse events|Days 0 - 126|All subjects who received at least one dose of investigational product (MEDI-528 or placebo)||Participants|||Number
730200|NCT00394654|Secondary|Incidence of Adverse Events|Number of participants experiencing adverse events (includes both adverse events and serious adverse events)|Days 0 - 126|All subjects who received at least one dose of investigational product (MEDI-528 or placebo)||Participants|||Number
730202|NCT00394654|Primary|Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 28|Change from baseline (percent reduction) in mean maximum decline of AUC of the participants FEV1 during LAR at 3 to 7 hours after an inhaled allergen challenge.|Day 28|All participants who were randomized into the study and completed the second allergen challenge on Day 7.||Percent||Standard Deviation|Mean
730203|NCT00394654|Primary|Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 7|Change from baseline (percent reduction) in mean maximum decline of area under the concentration-time curve (AUC) of the participants FEV1 during LAR at 3 to 7 hours after an inhaled allergen challenge.|Day 7|All participants who were randomized into the study and completed the second allergen challenge on Day 7.||Percent||Standard Deviation|Mean
730204|NCT00394654|Primary|Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 56|Change from baseline (percent reduction) in mean maximum decline of FEV1 during LAR at 3 to 7 hours after an inhaled allergen challenge.|Day 56|All participants who were randomized into the study and completed the second allergen challenge on Day 7.||Percent||Standard Deviation|Mean
730205|NCT00394654|Primary|Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 28|Change from baseline (percent reduction) in mean maximum decline of FEV1 during LAR at 3 to 7 hours after an inhaled allergen challenge.|Day 28|All participants who were randomized into the study and completed the second allergen challenge on Day 7.||Percent||Standard Deviation|Mean
730206|NCT00394654|Primary|Effect of MEDI-528 on Late Asthmatic Response (LAR) After Inhaled Allergen Challenge at Day 7|Change from baseline (percent reduction) in mean maximum decline of forced expiratory volume in one second (FEV1) during LAR at 3 to 7 hours after an inhaled allergen challenge.|Day 7|All participants who were randomized into the study and completed the second allergen challenge on Day 7.||Percent||Standard Deviation|Mean
730207|NCT00394706|Secondary|Health Utilities Index III Score and Geriatric Depression Scale Score 6 Months||6 months post hospital discharge||||||
730208|NCT00394706|Secondary|Adult Lifestyle and Function Version of Mini-Mental Status Exam at 6 Months||6 months post hospital discharge||||||
730209|NCT00394706|Secondary|Modified Rankin Score at 6 Months After Hospital Discharge|The modified Rankin Score (mRS) measures the ability of patients to function independently. The scale goes from 0 (no symptoms) to 6 (death).|6 months post hospital discharge||||||
730210|NCT00394706|Secondary|Survival to Hospital Discharge||Survival to hospital discharge or death before discharge|Analyses of both interventions excluded subjects who suffered arrest secondary to drowning, strangulation, or electrocution; or for whom the primary outcome was unknown. Additionally, the ITD vs. Sham analysis excluded subjects who did not have the device applied, had study exclusions, or who had a response time of more than 15 minutes.||participants|||Number
730211|NCT00394706|Primary|Survival to Hospital Discharge With Satisfactory Function (Modified Rankin Scale [MRS] of Less Than or Equal to 3).|The modified Rankin Score (mRS) measures the ability of patients to function independently. The scale goes from 0 (no symptoms) to 6 (death). Subjects with a mRS scores of three or less (i.e. better) at the time of hospital discharge were considered to have a positive outcome, resulting in a binary measure.|Hospital discharge or death prior to discharge|Analyses of both interventions excluded subjects who suffered arrest secondary to drowning, strangulation, or electrocution; or for whom the primary outcome was unknown. Additionally, the ITD vs. Sham analysis excluded subjects who did not have the device applied, had study exclusions, or who had a response time of more than 15 minutes.||participants|||Number
730212|NCT00394771|Other Pre-specified|Number of Moderate to Heavy Bleeding Days During Active Cycle 2 (Day 92-176)|Bleeding is defined as a flow heavy enough to require sanitary protection. Participants recorded in the diary days when they had bleeding, and whether they considered the bleeding to be light, moderate or heavy.|Day 92-176|Intent to treat (ITT) population of participants who were still active in the study and who completed the relevant pages in the patient diary.||days||Full Range|Median
730213|NCT00394771|Other Pre-specified|Number of Moderate to Heavy Bleeding Days During Active Cycle 1 (Day 1-84)|Bleeding is defined as a flow heavy enough to require sanitary protection. Participants recorded in the diary days when they had bleeding, and whether they considered the bleeding to be light, moderate or heavy.|Day 1-84|Intent to treat (ITT) population of participants who completed the relevant pages in the patient diary.||days||Full Range|Median
730214|NCT00394771|Secondary|Participants Reporting Hormone-Related Symptoms During the 7-day Withdrawal Cycle 2 (Day 177-183)|Hormone-related symptoms include breast tenderness/pain, headache, bloating, pelvic pain, anxiety, depression, and irritability.|Day 177-183|Intent to treat (ITT) population of participants who were still active in the study and who completed the relevant pages in the patient diary.||participants|||Number
730215|NCT00394771|Secondary|Participants Reporting Hormone-Related Symptoms During the 7-day Withdrawal Cycle 1 (Day 85-91)|Hormone-related symptoms include breast tenderness/pain, headache, bloating, pelvic pain, anxiety, depression, and irritability.|Day 85-91|Intent to treat (ITT) population of participants who completed the relevant pages in the patient diary.||participants|||Number
730216|NCT00394771|Secondary|Participants Reporting Hormone-Related Symptoms During Active Cycle 2 (Day 92-176)|Hormone-related symptoms include breast tenderness/pain, headache, bloating, pelvic pain, anxiety, depression, and irritability.|Day 92-176|Intent to treat (ITT) population of participants who were still active in the study and who completed the relevant pages in the patient diary.||participants|||Number
730217|NCT00394771|Secondary|Participants Reporting Hormone-Related Symptoms During Active Cycle 1 (Day 1-84)|Hormone-related symptoms include breast tenderness/pain, headache, bloating, pelvic pain, anxiety, depression, and irritability.|Day 1-84|Intent to treat (ITT) population of participants who completed the relevant pages in the patient diary.||participants|||Number
730218|NCT00394771|Secondary|Participants With Bleeding and/or Spotting Days During the 7-day Withdrawal During Cycle 2 (Day 177-183)|Participants are categorized by the duration of bleeding that occurred during the scheduled 7-day withdrawal period for Cycle 2.|Day 177-183|Intent to treat (ITT) population of participants who were still active in the study and who completed the relevant pages in the patient diary.||participants|||Number
730219|NCT00394771|Secondary|Participants With Bleeding and/or Spotting Days During the 7-day Withdrawal During Cycle 1 (Day 85-91)|Participants are categorized by the duration of bleeding that occurred during the scheduled 7-day withdrawal period for Cycle 1.|Day 85-91|Intent to treat (ITT) population of participants who completed the relevant pages in the patient diary.||participants|||Number
730220|NCT00394771|Primary|Days With Bleeding and/or Spotting During Active Cycle 2 (Day 92-176)|Bleeding is defined as a flow heavy enough to require sanitary protection. Spotting does not require sanitary protection.|Day 92-176|Intent to treat (ITT) population of participants who were still active in the study and who completed the relevant pages in the patient diary.||days||Full Range|Median
730221|NCT00394771|Secondary|Maximum Bleeding Severity During Active Cycle 1 (Day 1-84)|"Bleeding is defined as a flow heavy enough to require sanitary protection. Participants recorded in the diary days when they had bleeding, and whether they considered the bleeding to be light, moderate or heavy.
Data was not summarized due to limitations in the diary data, and an inability to accurately determine the maximum bleeding severity.
See pre-specified analyses for Number of Moderate to Heavy Bleeding Days."|Day 1-84|ITT population. However data was not summarized due to limitations in the diary data.|||||
730222|NCT00394771|Secondary|Time to First Bleeding Day|"Time to first bleeding day was defined as the time between the start of intervention until the first day when bleeding was heavy enough to require the use of sanitary protection.
Data are not summarized due to limitations in the diary data and an inability to accurately determine a participant's first day of bleeding."|Day 1-84|ITT population. However this data was not summarized due to limitations in the diary data.|||||
730223|NCT00394771|Secondary|Days With Bleeding During Active Cycle 2 (Day 92-176)|Bleeding is defined as a flow heavy enough to require sanitary protection.|Day 92-176|Intent to treat (ITT) population of participants who were still active in the study and who completed the relevant pages in the patient diary.||days||Full Range|Median
730224|NCT00394771|Secondary|Days With Bleeding During Active Cycle 1 (Day 1-84)|Bleeding is defined as a flow heavy enough to require sanitary protection.|Day 1-84|Intent to treat (ITT) population of participants who completed the relevant pages in the patient diary.||days||Full Range|Median
730225|NCT00394771|Primary|Days With Bleeding and/or Spotting During Active Cycle 1 (Day 1-84)|Bleeding is defined as a flow heavy enough to require sanitary protection. Spotting does not require sanitary protection.|Day 1-84|Intent to treat (ITT) population of participants who completed the relevant pages in the patient diary.||days||Full Range|Median
730226|NCT00394836|Secondary|Vss After the Eighth Infusion (Visit 9, Week 7)|Vss is the volume of distribution at steady state of ofatumumab.|Visit 9 (Week 7; to up 10 months after dose)|FAS. Data were provided for the number of participants for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed. Interim results; data of 28 April 2009.||mL||Geometric Coefficient of Variation|Geometric Mean
730227|NCT00394836|Secondary|CL After the Eighth Infusion (Visit 9, Week 7)|CL is the clearance of drug from plasma, which is defined as the volume of plasma from which drug is removed per unit time.|Visit 9 (Week 7; up to 10 months after dose)|FAS. Data were provided for the number of participants for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed. Interim results; data as of 28 April 2009.||Milliliters per hour (mL/h)||Geometric Coefficient of Variation|Geometric Mean
730228|NCT00394836|Secondary|t1/2 After the Eighth Infusion (Visit 9, Week 7)|t1/2 is defined as terminal half-life, which is the time required for the amount of the drug in the body to decrease by half.|Visit 9 (Week 7; up to 10 months after dose)|FAS. Data were provided for the number of participants for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed. Interim results; data as of 28 April 2009.||hours||Geometric Coefficient of Variation|Geometric Mean
730229|NCT00394836|Secondary|AUC(0-inf) and AUC(0-168) After the Eighth Infusion (Visit 9, Week 7)|AUC is defined as the area under the ofatumumab concentration-time curve as a measure of drug exposure. AUC(0-168) is AUC from the start of infusion to 168 hours after the start of the infusion; AUC(0-inf) is AUC from the start of infusion extrapolated to infinity.|Visit 9 (Week 7; up to 10 months after dose)|FAS. Data were provided for the number of participants for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed. Interim results; data as of 28 April 2009.||Milligrams * hour per liter (mg.h/L)||Geometric Coefficient of Variation|Geometric Mean
730230|NCT00394836|Secondary|Ctrough and Cmax at the Eighth Infusion (Visit 9, Week 7)|Cmax is defined as the maximum concentration of drug in plasma samples. Ctrough is defined as the trough plasma concentration (measured concentration at the end of a dosing interval [taken directly before the start of the next infusion]).|Visit 9 (Week 7; up to 10 months after dose)|FAS. Data were provided for the number of participants who had a value. Cmax was not reported for one participant due to missing data. Participants withdrawn during the study were not analyzed. Interim results; data as of 28 April 2009.||Milligrams per liter (mg/L)||Geometric Coefficient of Variation|Geometric Mean
730231|NCT00394836|Secondary|Number of Participants Classified as Responders for Fragment C Receptor (FcR) Polymorphism (Poly.)|FcR poly. affect the affinity with which FcRs interact with immunoglobulin molecules and are prognostic factors that are indicative of altered responsiveness to treatment and/or survival. A blood sample was drawn at Visit 1 for analysis (done in batches of several samples) of FcR poly. (Fcgamma RIIIa Valine/Phenylalanine genotypes [TT=thymidine/thymidine, TG=thymidine/guanine, GG=guanine/guanine] and Fcgamma RIIa Arginine/Histidine genotypes [AA=adenine/adenine, AG=adenine/guanine, GG=guanine/guanine]). Responders must have met the criteria for CR, CRu, or PR at either Month 3 or Month 6. Fc receptor polymorphisms and C1qA-276 results are not included in this results summary.|From first treatment (Visit 2) until Visit 12 (Month 6)|FAS. Data were provided for the number of participants attending each visit. Participants withdrawn during the study were not analyzed.||participants|||Number
730232|NCT00394836|Secondary|Complement (CH50) Levels at Visit 1 and at the End of Infusion at Visit 2|Blood samples were drawn from participants at Visits 1 and 2 for analysis of complement (CH50) levels. Analysis of CH50 was done in batches, and CH50 levels were measured two hours after the end of study medication infusion. Percent change from Screening (Visit 1, Week -2) = (value at Visit 2 minus the value at Visit 1 divided by the value at Visit 1) * 100.|Visits 1 (Week -2) and 2 (Week 0)|FAS. Data were provided for the number of participants attending each visit. Participants withdrawn during the study were not analyzed.||Units per milliliter (U/mL)||Full Range|Median
730233|NCT00394836|Secondary|Number of Participants With Positive Human Anti-human Antibodies (HAHA) at Visits 1, 12, 13, and 14|HAHA are indicators of immunogenicity to ofatumumab. Blood samples were withdrawn from participants at Visits 1, 12, 13, and 18 for analysis of HAHA. Analysis of HAHA was done in batches.|Visits 1 (Screening), 12 (Month 6), 13 (Month 9), and 18 (Month 24)|FAS. Data were provided for the number of participants attending each visit. Participants withdrawn during the study were not analyzed.||participants|||Number
730234|NCT00394836|Secondary|Number of Participants Who Experienced Any Adverse Event From First Treatment (Visit 2) to Visit 18 (Month 24)|An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. A list of AEs experienced in the study at a frequency threshold of 5% can be found in the AE section.|From first treatment (Visit 2) until Visit 18 (Month 24)|FAS||participants|||Number
730235|NCT00394836|Secondary|Number of Participants With Conversion and no Conversion of BCL2 Positive to BCL2 Negative in Peripheral Blood|"B-cell lymphoma 2 (BCL2) is the second member of a range of proteins initially described in chromosomal translocations involving chromosomes 14 and 18 in follicular lymphomas. BCL2 mitochondrial ribonucleic acid (mRNA) was measured by polymerase chain reaction (PCR) from peripheral blood. Participants who had no post-screening data were categorized as Missing."|Screening (Visit 1) until Month 24 (Visit 18)|FAS. Only those participants who were BCL2 positive at Screening were analyzed.||participants|||Number
730236|NCT00394836|Secondary|Percent Change From Baseline (Visit 2) in CD19+ and CD20+ Cells in Peripheral Blood at Visits 11 and 12|CD19 and CD20 are proteins found on the cell surface of B cells, and they can be detected in peripheral blood by flow cytometry. Flow cytometry of peripheral blood was performed for immediate analysis of cells with cluster of differentiation 19 (CD19+) and CD20+. The analysis will be done until a value is reached that is in the normal range. Percent change from Baseline (Visit 2) = (value at Visits 11 and 12 minus the value at Visit 2 divided by the value at Visit 2) * 100.|Visits 2 (Baseline), 11 (Month 3), and 12 (Month 6)|FAS. Data were provided for the number of participants attending each visit. Participants withdrawn during the study were not analyzed.||percent change in cells||95% Confidence Interval|Median
730237|NCT00394836|Secondary|Percent Change From Screening (Visit 1) in Tumor Size as Assessed by Radiologist 1 (R1) and Radiologist 2 (R2) at Months 3, 6, 9, 12, 18, and 24|Tumor size was measured by computed tomography (CT) scan and was computed as the sum of product of diameters (SPD) for the indicator lesions. CT scans with contrast of the neck, thorax, abdomen, and pelvis were performed at Screening and during the follow-up period (Month 3, 6, 9, 12, 18, and 24). The change in tumor size from Screening (Visit 1) was presented per Radiologist 1 (R1) and Radiologist 2 (R2). Percent change from Screening (Visit 1, Week -2) = (value at Visits 11, 12, 13, 14, 16, and 18 minus the value at Visit 1 divided by the value at Visit 1) * 100.|Visits 1 (Week -2), 11 (Month 3), 12 (Month 6), 13 (Month 9), 14 (Month 12), 16 (Month 18), and 18 (Month 24)|FAS. Data were provided for the number of participants attending each visit. Participants withdrawn during the study were not analyzed.||percent change in tumor size||Full Range|Median
730238|NCT00394836|Secondary|Overall Survival|Overall survival is defined as the time from randomization until death. For participants who are lost to follow-up, overall survival will be censored at the date of the last attended visit at which the endpoint was assessed.|First dose (Week 0) until 5 years|FAS. As of the time of data cut-off, data for Overall Survival was not estimable because too few deaths have occurred at the time of study completion.||Months||95% Confidence Interval|Median
730239|NCT00394836|Secondary|Time to Next Follicular Lymphoma (FL) Therapy|Time to next FL (anti-lymphoma) therapy is defined as the time from randomization until the time of first administration of the next anti-lymphoma therapy other than ofatumumab. For participants who were lost to follow-up, the time was censored at the date of the last attended visit at which the endpoint was assessed.|From start of treatment (Week 0) until Month 24|FAS||Months||95% Confidence Interval|Median
730240|NCT00394836|Secondary|Progression-Free Survival|Progression-free survival (PFS) is defined as the time from randomization until the first radiologically or clinically documented evidence of progression or death due to any cause, if sooner. For participants who were lost to follow-up, PFS was censored at the date of the last attended visit at which the endpoint was assessed. The Kaplan-Meier method was used to estimate PFS.|From start of treatment (Week 0) until Month 24|FAS||Months||95% Confidence Interval|Median
730241|NCT00394836|Secondary|Duration of Response|The duration of response is defined as the time from the initial response (the first visit at which response was observed) to progression or death. For participants who were lost to follow-up, duration of response was censored at the date of the last attended visit at which the endpoint was assessed. The Kaplan-Meier method was used to estimate duration of response.|From start of treatment (Week 0) until Month 24|FAS. Only those participants classified as responders were analyzed.||months||95% Confidence Interval|Median
730242|NCT00394836|Primary|Number of Participants Classified as Responders and Non-responders for Objective Response (OR)|Based on OR over a 6-month period from start of treatment, participants were classified as responders/non-responders as follows: participants with CR, CRu, or PR were classified as responders, whereas participants with Stable Disease (SD; achieving less than PR but not consistent with PD), Progressive Disease (PD; 50% increase from nadir in the products of the greatest perpendicular diameters of any previously identified node or appearance of any new node >1 cm), or Not Evaluable (NE) participants were classified as non-responders.|6-month period from the start of treatment. There was a median time of response at Month 5.5 (participants were followed for up to 24 months).|FAS||participants|||Number
730243|NCT00394836|Primary|Number of Participants With Objective Response (OR)|OR was assessed by an Independent endpoints Review Committee (IRC) according to the standardized response criteria for Non-Hodgkin's lymphoma. Participants with Complete Response (CR; complete disappearance of all detectable disease), Complete Response unconfirmed (CRu; any residual lymph node/nodal mass >1.5 centimeters [cm] in its longest transverse diameter that regressed >75% compared to baseline), or Partial Response (PR; >=50% decrease in the sum of the product of diameters of indicator lesions) were defined as responders for OR.|Start of treatment (Day 1 of Week 0) until 3 months after start of last infusion (up to Week 32)|Full Analysis Set (FAS): all participants who were exposed to study drug irrespective of their compliance to the planned course of treatment||participants|||Number
730244|NCT00381381|Primary|CERAD-K|CERAD-K includes: Trail making test A and B is scored by the time spent to link randomly arranged numbers and alphabets in correct order. Except Trail making test A and B, higher score presents better condition.|26 weeks|||Second||Standard Deviation|Mean
730245|NCT00381381|Secondary|GDS-K (Geriatric Depression Scale-Korean) Score After Treatment|GDS-K score after treatment. Geriatric Depression Scale is a basic screening measure for depression in older adults. It ranges from 0 to 30, and higher score represents more depressed.|26 weeks|||Units on Scale||Standard Deviation|Mean
730246|NCT00381381|Secondary|Neuropsychiatry Inventory (NPI)|NPI score after treatment. NPI includes 12 sections which are Delusions, Hallucinations, Agitation, Depression, Anxiety, Euphoria, Apathy, Disinhibition, Irritability, Aberrant motor behavior, Night-time behaviors and Appetite and eating disorders. The score of each section ranges from 0 to 12, and higher score means higher severity and frequency of the neuropsychiatric disturbances.|26 weeks|||Units on Scale||Standard Deviation|Mean
730247|NCT00381381|Primary|CERAD-K (the Korean Version of the Consortium to Establish a Registry for Alzheimer’s Disease)|CERAD-K includes: Verbal Fluency-number of kinds of animal patients listed per minute, ranges from 0, no maximum point fixed.Boston Naming Test is naming objects (0-15). Mini-Mental State Examination in the Korean version of CERAD Assessment Packet (0-30). Word List Memory (0-30). Construction Praxis is from 0-11. Word List Recall and Word List Recognition ranges from 0-10.Construction Recall (0-11).|26 weeks|||Units on Scale||Standard Deviation|Mean
730248|NCT00381485|Secondary|Change From Baseline in Proportion of Nights Across the Treatment Period With Nocturnal Awakenings Due to Asthma That Require Use of Short-Acting Beta Agonists (SABA)|Baseline was the proportion of nights of the last week (Days -7 to 1) prior to first dose with nocturnal awakenings. Scale is measured as 0 to 1 with 0 = no awakenings to 1 = awakenings every night. The comparison was for MF/F versus placebo. Standard deviation was pooled.|12-week Treatment Period|Efficacy analyses were based on randomized subjects with Baseline and any post-baseline data (intent-to-treat principle).||Proportion of nights||Standard Deviation|Least Squares Mean
730249|NCT00381485|Secondary|Change From Baseline to Week 12 in Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ[S]) Total Score|AQLQ(S) consists of 32 questions each scaled from 1 (worst case) to 7 (best case). The AQLQ(S) Total score was the mean of the individual 32 questions. The comparison was for MF/F versus placebo. Standard deviation was pooled.|Baseline to Week 12|Efficacy analyses were based on randomized subjects with Baseline and any post-baseline data (intent-to-treat principle).||Units on a Scale||Standard Deviation|Least Squares Mean
730250|NCT00381485|Secondary|Change From Baseline to Week 12 in Asthma Control Questionnaire (ACQ) Total Score|ACQ consists of seven questions each scaled from 0 (best case) to 6 (worst case). The ACQ Total score was the mean of the individual seven questions. The comparison was for MF/F versus placebo. Standard deviation was pooled.|Baseline to Week 12|Efficacy analyses were based on randomized subjects with Baseline and any post-baseline data (intent-to-treat principle).||Units on a Scale||Standard Deviation|Least Squares Mean
730251|NCT00381485|Primary|Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 12 in Forced Expiratory Volume (Liters) in 1 Second (FEV1)|The average of the two predose FEV1 measurements (30 minutes prior to dosing and 0 hour, immediately prior to dosing) at the Baseline Visit were subtracted from each of the serial measurements over the 12-hour period. The AUC was calculated based on these changes from Baseline evaluations. The comparison was for MF/F versus MF. Standard deviation was pooled.|Baseline to Week 12|Efficacy analyses were based on randomized subjects with Baseline and any post-baseline data (intent-to-treat principle).||Liter x hour||Standard Deviation|Least Squares Mean
730252|NCT00381550|Primary|Incidence of Grade 3 or 4 Drug-related Non-hematologic Toxicity as Assessed by NCI CTCAE v3.0||Up to 4 years|||participants|||Number
730253|NCT00381550|Primary|Response Rate Including Complete Response, Partial Response, and Hematological Improvement Assessed by Blood Cell Counts, Number of Blasts in Bone Marrow, and Clinical Evaluation|Bone marrow aspiration and biopsies were performed prior to treatment, during week 3 of the first cycle, at the time of hematologic recovery from all cycles of therapy (defined as neutrophil count >500/mm3 and platelets >20,000/mm3 independently of transfusion), or at any time that leukemia regrowth was suspected. The overall response rate was defined as complete remission, partial remission, or hematologic improvement, lasting for ≥30 days. Given the different subsets of diseases, standardized response criteria were used for CMML (the Myelodysplastic Syndrome International Working Group criteria),33 CMML transforming to acute myeloid leukemia (standard AML response criteria) , accelerated MPN (Giles et al.), and transformation of MPN to secondary AML (Mascarenhas et al.).|Up to 4 years|||participants|||Number
730254|NCT00381563|Secondary|Change in WOMAC Function Scale|The WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) is a self-administered health status measure for pain, stiffness, and function in patients with knee or hip OA. It measures Pain (5 questions), Stiffness (2 questions), and Function (17 questions). The WOMAC function score ranges from 0-68, all items are scored on a scale of 0-4 (0 = None, 1 = Slight, 2 = Moderate, 3 = Very, 4 = Extremely) for difficulty of specific functions. Lower overall function scores indicate higher levels of functioning or less difficulty performing a list of 17 specific activities.|6 weeks|"In this cross-over design where in one arm participants received the neutral brace with a realigning strap for the first 6 weeks then the neutral brace without a realigning strap for the second 6 weeks and the other arm used them in the opposite order, all 67 participants who completed the trial are re-grouped into the intervention brace group."||units on a scale change from baseline||95% Confidence Interval|Mean
730255|NCT00381563|Primary|Change in WOMAC Pain Scale|The WOMAC (Western Ontario and McMaster Osteoarthritis Index) is a widely used self-administered health status measure used in assessing pain, stiffness, and function in patients with OA of the hip or knee. It measures Pain (5 questions), Stiffness (2 questions), and Function (17 questions). The WOMAC pain scale ranges from 0-20. All the items are scored on a scale of 0-4 (0 = None, 1 = Slight, 2 = Moderate, 3 = Very, 4 = Extremely). Lower scores indicate lower levels of pain.|6 weeks|"In this cross-over design where in one arm participants received the neutral brace with a realigning strap for the first 6 weeks then the neutral brace without a realigning strap for the second 6 weeks and the other arm used them in the opposite order, all 67 participants who completed the trial are re-grouped into the intervention brace group."||units on a scale change from baseline||95% Confidence Interval|Mean
730256|NCT00381563|Primary|Change in Pain on the VIsual Analog Scale (VAS)|The pain VAS is a unidimensional measure of pain intensity, which has been widely used in diverse adult populations, including those with rheumatic diseases. It is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (pain) orientated from the left (best) to the right (worst).The visual analog scale (VAS) pain ranges from 0-100|6 weeks|"In this cross-over design where in one arm participants received the neutral brace with a realigning strap for the first 6 weeks then the neutral brace without a realigning strap for the second 6 weeks and the other arm used them in the opposite order, all 67 participants who completed the trial are re-grouped into the intervention brace group."||change in units on a scale from baseline||95% Confidence Interval|Mean
730257|NCT00381615|Secondary|Percentages of Subjects With Bactericidal Titers, BCA, ≥1:4 After the Second Immunization and at 12 Months Age|Percentages of subjects treated with Novartis rMenB Vaccine +/- OMV NZ (Groups I and II) with a BCA titer ≥1:4 for the three meningococcal B strains (Strain 44/76-SL, Strain 5/99, Strain NZ98/254) at 30 days after the second vaccination and at 12 months age, and 1 month after fourth (booster) vaccination. The analysis was done on the Per Protocol population.|At baseline (pre-vaccination) and 30 days after the second vaccination and at 12 months age.|||Percentages of Subjects||95% Confidence Interval|Number
730258|NCT00381615|Secondary|Percentages of Subjects With Fourfold Rises in Bactericidal Titers After the Second Immunization and at 12 Months Age|Percentages of subjects treated with Novartis rMenB Vaccine +/- OMV NZ (Groups I and II) with fourfold rises in bactericidal titers for the three meningococcal B strains (Strain 44/76-SL, Strain 5/99, Strain NZ98/254) at 30 days after the second vaccination and at 12 months age, i.e. 6 months after third (pre-booster) vaccination, and 1 month after fourth (booster) vaccination. The analysis was done on the Per Protocol population 30 days after the second vaccination and at 12 months age.|At pre-vaccination and 30 days post the 2nd vaccination and at 12 months age, and 1 month post 4th (booster) vaccination.|||Percentages of Subjects||95% Confidence Interval|Number
730259|NCT00381615|Secondary|Geometric Mean Ratios to Baseline Against a Panel of Genetically Distinct Meningococcal Strains 30 Days After a Single Dose Administered at 12 Months of Age|Geometric Mean Ratios to baseline against a panel of genetically distinct meningococcal strains 30 days after a single dose administered at 12 months of age.|1 month after first vaccination|||Ratio||95% Confidence Interval|Geometric Mean
730260|NCT00381615|Primary|Geometric Mean Ratios to Baseline Against a Panel of Genetically Distinct Meningococcal Strains 30 Days After the Third Immunization.|Geometric Mean Ratios (GMRs) as measure of the bactericidal activity against the for the three major meningococcal B strains (Strain 44/76-SL, Strain 5/99, Strain NZ98/254) in subjects treated with Novartis rMenB Vaccine +/- OMV NZ (Groups I and II) at 30 days after the third immunization. The analysis was done on the Per Protocol population at one month after third injection.|At baseline (pre-vaccination) and 30 days after the third vaccination|||Ratio||95% Confidence Interval|Geometric Mean
730261|NCT00381615|Primary|Percentage of Subjects With Fourfold Rises in Bactericidal Titers Against Meningococcal Strains One Month After Third-Dose of Infants Series Vaccination or rMenB Vaccine With and Without OMV-NZ.|Percentage of subjects fourfold increase in bactericidal titers against meningococcal strains 44/76-SL, 5/99 and NZ98/254 were measured at one month after third-dose and calculated respect to baseline titers.|30 days after the third vaccination|Analysis was performed on the Per Protocol Set (PP) set, i.e. all subjects in the enrolled population who received all the relevant doses of vaccine correctly; provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to analysis.||Percentage of Subjects||95% Confidence Interval|Number
730262|NCT00381615|Primary|Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study|Safety was assessed as the number of subjects who reported solicited systemic reactions and other indicator of reactogenicity from day 1 through day 7 after each vaccination administered during study as follow: rMenB vaccine with and without OMV, PC7, DTaP-Hib-IPV at 2 months (vaccination 1), MenC-CRM, DTaP-Hib-IPV at 3 months (vaccination 2), rMenB vaccine with and without OMV, PC7, DTaP-Hib-IPV at 4 months (vaccination 3), MenC-CRM at 5 months (vaccination 4), rMenB vaccine with and without OMV at 6 months (vaccination 5; rMenB and rMenB+OMV groups only), rMenB vaccine with and without OMV at 12 months (vaccination 5; routine and routine+OMV groups only), and rMenB vaccine with and without OMV (vaccination 6; rMenB and rMenB+OMV groups only).|Day 1 through day 7 after each vaccination|Analysis was performed on the safety set.||Number of subjects|||Number
730263|NCT00381615|Primary|Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of MenC-CRM or MenC-Hib|Safety was assessed as the number of subjects who reported solicited local reactions from day 1 through day 7 after each vaccination of MenC-CRM administered at 2 months (vaccination 1) and 5 months (vaccination 2). MenC-Hib was administered at 12 months of age (vaccination 3).|Day 1 through day 7 after each vaccination|Analysis was performed on the safety set.||Number of subjects|||Number
730264|NCT00381615|Primary|Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of DTaP-Hib-IPV Pentavalent Vaccine|Safety was assessed as the number of subjects who reported solicited local reactions from day 1 through day 7 after each vaccination of the pentavalent vaccine DTaP-Hib-IPV administered at 2 months (vaccination 1), 3 months (vaccination 2) and 4 months (vaccination 3).|Day 1 through day 7 after each vaccination|Analysis was performed on the safety set.||Number of subjects|||Number
730265|NCT00381615|Primary|Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of PC7|Safety was assessed as the number of subjects who reported solicited local reactions from day 1 through day 7 after each vaccination of PC7 administered at 2 months (vaccination 1) and 4 months (vaccination 3).|Day 1 through day 7 after each vaccination|Analysis was performed on the safety set.||Number of subjects|||Number
730266|NCT00381615|Primary|Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV|Safety was assessed as the number of subjects who reported solicited local reactions from day 1 through day 7 after each vaccination of rMenB vaccine with and without OMV administered at 2 months (vaccination 1), 4 months (vaccination 2), 6 months (vaccination 3) and 12 months (vaccination 4; vaccination 1 for Routine and Routine+OMV groups).|Day 1 through day 7 after each vaccination|Analysis was performed on the safety set, i.e. the subjects in the exposed population who provided postvaccination safety data.||Number of subjects|||Number
730267|NCT00381615|Secondary|Percentages of Subjects With Bactericidal Titers ≥1:4 at 12 Months Age|Percentages of subjects treated with Routine + Novartis rMenB Vaccine +/- OMV NZ (Groups III and IV) with a bactericidal activity (BCA) measured as BCA titer ≥1:4 for the for three major meningococcal B strains (Strain 44/76-SL, Strain 5/99, Strain NZ98/254) at 12 months age, i.e. pre-first vaccination, and 1 month after first vaccination. The analysis was done on the Per Protocol population at 12 months age, i.e. pre-first vaccination, and 1 month after first vaccination.|pre-first vaccination and 1 month after first vaccination|Analysis was performed on the PP set after booster vaccination.||Percentage of subjects||95% Confidence Interval|Number
730372|NCT00387881|Secondary|Incidence of Headache Associated: Neck Pain, Sinus Pain, Photophobia, Phonophobia, Nausea at Time Intervals of 4 and 2 Hours After Treatment|Neck pain, sinus pain, photophobia, phonophobia and nausea are considered headache-associated symptoms.(Headache-associated=Headache-Assoc.)|2 and 4 hours after treatment|ITT Population||Participants|||Number
730268|NCT00381615|Secondary|Geometric Mean Ratios (GMRs) to Baseline Against a Panel of Genetically Distinct Meningococcal Strains 30 Days After the Second Immunization and 1 Month After Fourth (Booster) Vaccination|Geometric Mean Ratios (GMRs) as measure of the bactericidal activity against meningococcal B strains (Strain 44/76-SL, Strain 5/99, Strain NZ98/254) in subjects treated with Novartis rMenB Vaccine +/- OMV NZ (Groups I and II) at 30 days after the second immunization and 1 month after fourth (booster) vaccination. The analysis was done on the Per Protocol population at 30 days after the second immunization and 1 month after fourth (booster) vaccination.of age.|30 days after the second vaccination and 1 month after fourth (booster) vaccination|Analysis was performed on the PP set.||ratios||95% Confidence Interval|Geometric Mean
730269|NCT00381615|Secondary|Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to and 30 Days After a Single Dose Administered at 12 Months of ageVaccination of rMenB Vaccine With and Without OMV-NZ|Geometric Mean Titers (GMTs) as measure of the bactericidal activity against the for the three major meningococcal B strains (Strain 44/76-SL, Strain 5/99, Strain NZ98/254) in subjects treated with Routine +Novartis rMenB Vaccine +/- OMV NZ (Groups III and IV) at 12 months age, i.e. pre-first vaccination and 1 month after first vaccination. The analysis was done on the Per Protocol population.|pre-first vaccination and 1 month after first vaccination|Analysis was performed on the PP set.||titers||95% Confidence Interval|Geometric Mean
730270|NCT00381615|Secondary|Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to the First Dose, 30 Days After the Second Immunization and at 12 Months Age|Geometric mean bactericidal titers as measure of the Bactericidal activity against meningococcal strains 44/76-SL, 5/99 and NZ98/254, before vaccination (baseline) and at 30 days after second immunization, at 12 months age,and 30 days after the fourth (booster) vaccination.|prior 1st dose, 30 days post-2nd vaccination, 12 months age to 1 month post 4th vaccination|Analysis was performed on the PP set.||titers||95% Confidence Interval|Geometric Mean
730271|NCT00381615|Primary|Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Third-Dose of Infants Series Vaccination of rMenB Vaccine With and Without OMV-NZ|The immune response was measured as the geometric mean bactericidal titers directed against meningococcal strains 44/76-SL, 5/99 and NZ98/254, before vaccination (baseline) and at one month after third-dose of infants series vaccination of rMenB vaccine with and without OMV administered at 6 months of age.|Baseline and one month after third-dose of infants series|Analysis was performed on the PP set.||titers||95% Confidence Interval|Geometric Mean
730272|NCT00381615|Secondary|Percentages of Subjects With Fourfold Rises in Bactericidal Titers 1 Month After First Vaccination|Percentages of subjects treated with Routine + Novartis rMenB Vaccine +/- OMV NZ (Groups III and IV) with fourfold rises in bactericidal titers for the three major meningococcal B strains (Strain 44/76-SL, Strain 5/99, Strain NZ98/254) 1 month after first vaccination. The analysis was done on the Per Protocol population 1 month after first vaccination.|1 month after first vaccination|Analysis was performed on the PP set.||Percentage of subjects||95% Confidence Interval|Number
730273|NCT00381615|Primary|Percentage of Subjects With Bactericidal Titers, BCA ≥1:4, 30 Days After the Third Immunization|Immunogenicity was measured as percentage of subjects who achieved bactericidal titers ≥1:4 against meningococcal strains 44/76-SL, 5/99 and NZ98/254, evaluated using serum bactericidal assay, before vaccination (baseline) and at one month after third-dose of Infants series vaccination of rMenB vaccine with and without OMV administered at 6 months of age.|Baseline and one month after third-dose of infants series|Analysis was performed on the per protocol (PP) set, i.e. all subjects in the enrolled population who received all the relevant doses of vaccine correctly; provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to analysis.||Percentage of subjects||95% Confidence Interval|Number
730274|NCT00381628|Primary|The Number of Participants With Blood and Sputum Samples Collected|Blood and sputum samples for general science research collaborators|Baseline|These samples were to be distributed to research collaborators and were not part of a clinical trial. These samples were not analyzed for a specific outcome.||Participants|||Count of Participants
730275|NCT00381641|Other Pre-specified|Changes in Laboratory Correlates Analyzed Using Paired T-tests|Relevant laboratory correlates will be compared between responders and non-responders using the Wilcoxon rank sum test. The association between the presence or absence of RET gene rearrangements/mutations and tumor response, as well as the association between germ-line polymorphisms in the RET gene and response, will be analyzed using Fisher’s exact test. The correlative and genetic data will also be entered as covariates (univariate analyses only due to the small sample size) in a Cox regression model of progression-free survival.|Baseline to 2 years||||||
730276|NCT00381641|Secondary|Time to Progression or Death Evaluated Using the RECIST||Time from start of treatment to time of progression or death of any cause, assessed up to 10 years|||Months||95% Confidence Interval|Median
730277|NCT00381641|Secondary|Overall Survival|Kaplan-Meier curves will be generated and 95% confidence intervals will be derived for median overall survival.|Up to 10 years|||Months||95% Confidence Interval|Median
730278|NCT00381641|Secondary|Incidence of Toxicity, Graded According to the Common Terminology Criteria for Adverse Events Version 3.0|Any grade toxicity of any type, regardless of attribution|From time of first treatment with sunitinib, assessed up to 2 years|||Participants|||Count of Participants
730279|NCT00381641|Primary|Objective Response Rate, Assessed Using the Response Evaluation Criteria in Solid Tumors (RECIST)|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|Up to 2 years|||Participants|||Count of Participants
730280|NCT00381680|Secondary|Adjusted Event Free Survival|Adjusted percentage of patients who were event free at 3 years. For patients who received matched donor SCT, EFS was adjusted to start from the actual SCT date. For patients who did not undergo SCT, EFS was adjusted to start from median time to SCT based on patients who received matched related SCT (where patients who had events prior to SCT date were excluded from the calculation of median time to SCT).|3 years|The analysis is limited to eligible patients on Standard VCR dosing who received matched related SCT, excluding patients who had events prior to receiving SCT. And those patients on Regimen A who did not undergo SCT, excluding patients who went off therapy prior to the adjusted starting time.||adjusted percentage of participants||95% Confidence Interval|Number
730281|NCT00381680|Secondary|Event Free Survival (EFS)|Percentage of patients who were event free at 3 years among those with isolated BM or combined BM relapse >= 36 months.|3 years|The percentage of patients (pts) who were event free at 3 years among those with isolated BM or combined BM relapse >= 36 months. Pts with MRD <0.01% at the end of Block 1 (MRD < 0.01% BL1); MRD >= 0.01% at the end of Block 1 (MRD>= 0.01% BL1); MRD < 0.01% at the end of Block 3 (MRD < 0.01% BL3);MRD >=0.01% at the end of Block 3.||percentage of participants||95% Confidence Interval|Number
730282|NCT00381680|Secondary|Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 3|Percentage of patients who had minimal residual disease (MRD) < 0.01% among those with isolated BM or combined BM relapse >= 36 months and had successful MRD determinations at End Block 3.|End of Block 3 (105 days) of Induction therapy|This analysis is limited to all eligible patients with isolated BM or combined BM relapse >= 36 months and had successful MRD determinations at End Block 3.||percentage of participants|||Number
730283|NCT00381680|Secondary|Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 1|Percentage of patients who had minimal residual disease (MRD) < 0.01% among those with isolated BM or combined BM relapse >= 36 months and had successful MRD determinations at End Block 1|End of Block 1 (35 days) of Induction therapy|This analysis is limited to all eligible patients with isolated BM or combined BM relapse >= 36 months and had successful MRD determinations at End Block 1.||percentage of participants|||Number
730284|NCT00381680|Secondary|Gene Expression Profile|Percent of unfavorable gene expression profile of early versus late marrow relapse.|Up to 36 months|The data were not collected due to the lack of funds.|||||
730285|NCT00381680|Secondary|Frequency and Severity of Adverse Effects|Percentage of patients who developed at least 1 episode of grade 2 to 4 neuropathy.|Up to 107 weeks|The total number of patients for CC or CT genotype is 81 and for high-risk CEP72 genotype is 18. No related by arm data were provided.||percentage of participants||95% Confidence Interval|Number
730286|NCT00381680|Primary|Event Free Survival. EFS|Percentage of patients who were event free at 3 years among those on Standard VCR dosing who did not undergo Hematopoietic Stem Cell Transplant (SCT).|3 years after enrollment|The analysis is limited to eligible patients on regimen A (Standard VCR dosing) who did not undergo SCT.||percentage of participants EFS at 3 yrs3||95% Confidence Interval|Number
730287|NCT00381693|Secondary|Number of Participants With Treatment Related Adverse Events|"Adverse events (AE) that are classified as either possibly, probably, or definitely related to study treatment according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE version 3.0). The maximum grade for each type of AE will be recorded for each patient. Grade refers to the severity of the AE.
Grade 1: Mild AE, Grade 2: Moderate AE, Grade 3: Severe AE, Grade 4: Life-threatening or disabling AE, Grade 5: Death related AE"|Every 4 weeks during treatment|||Participants|||Number
730288|NCT00381693|Secondary|Time to Progression|Time to progression was defined as the time from registration to progression of disease. Those who die without documentation of disease progression will be considered to have had disease progression at the time of their death unless documented evidence clearly indicates no progression has occured.|up to 3 years|Only 2 out of 10 patients had disease progression. One patient progressed at 0.5 months after registration and one patient progressed at 2.8 months after registration. Thus, median of time to progression and upper limit of 95% confidence interval are not attainable.||months||95% Confidence Interval|Median
730289|NCT00381693|Secondary|Overall Survival (OS)|OS was defined as the time from registration to death due to any cause or time from registration to 3 years after registration if patient is still alive.|From date of registration until death or 3 years after registration if patient is still alive|||months||95% Confidence Interval|Median
730290|NCT00381693|Primary|Patients With Confirmed Response (Complete Remission or Partial Remission on 2 Consecutive Evaluation at Least 4 Weeks Apart) During the First 4 Months of Treatment|"Response Definitions:
Completion Remission (CR):complete resolution of disease-related symptoms, ultrasound-documented resolution of hepastosplenomegaly, normalization of the peripheral blood count, white cell differential, and smear, normalization of bone marrow histology including disappearance of fibrosis and osteosclerosis. Residual cytogenetic abnormalities are allowed.
Partial Remission (PR): a major response in any baseline applicable criteria (except constitutional symptoms) without progression in any other category."|4 months|||participants|||Number
730291|NCT00381706|Secondary|Time to Treatment Failure in Patients With Adenocarcinoma|Time to treatment failure (TTF) was measured from study entry until documented progression, death resulting from any cause, or end of protocol therapy because of unacceptable toxicity. The median TTF with 95% CI was estimated using the Kaplan Meier method.|Up to 2 years post-treatment|||months||95% Confidence Interval|Median
730292|NCT00381706|Secondary|Progression-free Survival in Patients With Adenocarcinoma|Progression free survival (PFS) was defined as the time from study entry to progression or death of any cause. The median PFS with 95% CI was estimated using the Kaplan Meier method.|Up to 2 years post-treatment|||months||95% Confidence Interval|Median
730293|NCT00381706|Secondary|Overall Survival in Patients With Adenocarcinoma|Overall survival (OS) was defined as the time from study entry to death of any cause. The median OS with 95% CI was estimated using the Kaplan Meier method.|Up to 2 years post-treatment|||months||95% Confidence Interval|Median
730294|NCT00381706|Secondary|Tumor Response Rate (Complete and Partial) in Patients With Squamous Cell Carcinoma|Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD): 20% increase in sum of longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria. Overall tumor response is the total number of CR and PRs in participants with squamous cell carcinoma who have received at least one cycle of therapy.|Up to 2 years post-treatment|4 participants did not meet the protocol defined requirements to be evaluated for response (measurable squamous cell carcinoma receiving at least 1 cycle of chemotherapy).||percentage of participants|||Number
730305|NCT00387127|Secondary|Number of Participants With Distant Recurrence of Initial Disease|Participants were analyzed for the occurrence of distant metastasis (spread of a disease from one organ or part to another non-adjacent organ or part) after randomization in the study until data cut-off date 1-Aug-2014. Participants who died or had recurrence of disease in the T or N sites or secondary primary malignancies in the head and neck region outside of the original T and N site were not counted as an event and were instead treated as competing risks.|From the date of randomization until the first occurrence of distant metastasis, assessed after a median of 30.9 months|ITT Population||Participants|||Number
730295|NCT00381706|Primary|Response Rate (Complete and Partial) in Patients With Measurable Esophageal or GE Junction Adenocarcinoma|Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD): 20% increase in sum of longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria. Overall tumor response is the total number of CR and PRs in participants with adenocarcinoma who have received at least one cycle of therapy.|Up to 2 years post-treatment|13 participants did not meet the protocol defined requirements to be evaluated for response (measurable adencarcinoma receiving at least 1 cycle of chemotherapy).||percentage of participants||95% Confidence Interval|Number
730296|NCT00387127|Other Pre-specified|Number of Participants Classified as Responders, as Per Volumetric Tumor Response|No analysis was not performed.|From the date of randomization until 6 months post chemoradiation treatment, assessed for a median of 13 months|ITT Population. A formal analysis of this outcome measure was never performed; thus data are not available and cannot be reported.|||||
730297|NCT00387127|Secondary|Number of Participants Positive and Negative for Biomarker HER1/ErbB1 Categorized in the Indicated Independent Review Panel-assessed Tumor Responses by Expression of Biomarkers From Tumor Tissues: Sensitivity Analysis - 0, 1, 2 Versus 3|Tumor tissue (fresh or archived) was sent to a central laboratory for biomarker HER1/ErbB1 and tumor genetics analysis up to 1 week after randomization. Per RECIST: CR, disappearance of all lesions; PR, a >=30% decrease in the sum of the longest dimensions (LD) of the target lesions (TLs) taking as a reference the baseline sum LD; Progressive disease (PD), a >=20% increase in the sum of the LD of TLs, or the appearance of >=1 new lesion; Stable Disease (SD), neither PR nor PD, persistence of >=1 non-TL. 0=negative; 1, 2, 3=positive (increasing level of biomarker expression).|From the date of randomization until 6 months post chemoradiation treatment, assessed for up to 24 weeks|ITT Population. Participants assessed for HER1/ ErbB1 expression were analyzed.||Participants|||Number
730298|NCT00387127|Secondary|Number of Participants Positive and Negative for Biomarker HER1/ErbB1 Categorized in the Indicated Independent Review Panel-assessed Tumor Responses by Expression of Biomarkers From Tumor Tissue: Sensitivity Analysis - 0 Versus (1, 2, 3)|Tumor tissue (fresh or archived) was sent to a central laboratory for biomarker HER1/ErbB1 and tumor genetics analysis up to 1 week after randomization. Per RECIST: CR, disappearance of all lesions; PR, a >=30% decrease in the sum of the longest dimensions (LD) of the target lesions (TLs) taking as a reference the baseline sum LD; Progressive disease (PD), a >=20% increase in the sum of the LD of TLs, or the appearance of >=1 new lesion; Stable Disease (SD), neither PR nor PD, persistence of >=1 non-TL. 0=negative; 1, 2, 3=positive (increasing level of biomarker expression).|From the date of randomization until 6 months post chemoradiation treatment, assessed for up to 24 weeks|ITT Population. Participants assessed for HER1/ ErbB1 expression were analyzed.||Participants|||Number
730299|NCT00387127|Secondary|Number of Participants Negative and Positive for Human Papilloma Virus (HPV) Infection, as Determined From Tumor Samples|"Analysis was performed for HPV infection analysis from the tumor biopsy samples obtained during the Screening period. p16 was used as a marker for HPV; thus, negative participants did not have the p16 marker."|Up to 28 days prior to the first dose of lapatinib/placebo|ITT Population||Participants|||Number
730300|NCT00387127|Secondary|Analysis of Deoxyribonucleic Acid (DNA) and Ribonucleic Acid (RNA) From Tumor Samples|No analysis was performed for tumor sample RNA/DNA.|Screening|ITT Population. DNA/RNA from tumors has not been analyzed (tested); therefore, data are not available. No suitable analyses of DNA/RNA have been proposed for this small sample size of tumor samples.|||||
730301|NCT00387127|Secondary|Plasma Proteome Analysis|Proteomic analyses of blood plasma samples were to be conducted to identify any changes in the proteome profile that could be related to the treatment response. Examination of pre-dosing (screening) plasma protein profiles could uncover novel blood-borne protein candidate biomarkers/profiles, which could be used to predict drug response.|From up to 28 days prior to the first dose of lapatinib/placebo start to 8 weeks after the first dose|ITT Population. Plasma proteome data have not been analyzed (tested); thus, data are not available to disclose. Based on the negative outcome of Study EGF102988 (NCT00424255), no suitable analyses have been proposed for this small sample size.|||||
730302|NCT00387127|Secondary|Number of Participants Positive and Negative for the Expression of Biomarkers in Tumor Tissue: Human Epidermal Growth Factor Receptor (HER)-1, HER2, HER3, HER4, P16, and Transforming Growth Factor (TGF-alpha)|Paraffin-embedded tissue block (or sections) from archived tumor tissue sample, if available (from time of original diagnosis) or fresh tumor tissue, was sent for testing to determine intra-tumoral biomarker expression by immunohistochemistry (IHC) or fluorescent in situ hybridization (FISH) assay. Stained tumor slides or tissue micro arrays (TMAs) were scored by a pathologist from 0 (no expression) to 3+ (high expression). An expression level of >=2+ was considered positive.|Up to 28 days prior to the date of the first dose of lapatinib/placebo start|ITT Population. Only those participants who had sufficient tumor sample for testing were analyzed.||Participants|||Number
730303|NCT00387127|Secondary|Number of Participants With Overall Response (OR), as Assessed by the Investigator|Participants with OR were those who achieved either a CR or partial response (PR) from the assessment of overall tumor response at 6 months (24 weeks) following completion of CRT (data cut-off 30-Sep-2010). Per RECIST, CR is defined as the disappearance of all target and non-target lesions; PR is defined as at least a 30% decrease in the sum of the long diameter (LD) of target lesions, taking as a reference, the baseline sum LD. Data are based on Week 24 scans from participants receiving study treatment at that time point.|From the date of randomization until 6 months post chemoradiation treatment, assessed for a median of 13 months|ITT Population||Participants|||Number
730304|NCT00387127|Secondary|Distant Relapse|Distant relapse is defined as the time from the date of randomization until the first occurrence of distant metastasis (spread of a disease from one organ or part to another non-adjacent organ of part). Participants who died or had recurrence of disease in the T or N sites or secondary primary malignancies in the head and neck region outside of the original T and N site were not counted as an event and were instead treated as competing risks.|From the date of randomization until the first occurrence of distant metastasis, assessed after a median of 30.9 months|ITT Population. If a participant had a distant metastasis and then died, then the participant was counted as having had an event of interest.||Months||Inter-Quartile Range|Median
730319|NCT00387335|Primary|Feasibility of Treatment|Ability to remain on treatment without dose reduction|While patient remains on treatment, up to 30 weeks|||percentage of participants||95% Confidence Interval|Number
730306|NCT00387127|Secondary|Loco-regional Control|Loco-regional control is defined as the time from the date of randomization until progression in the T or N site. Participants who died or had secondary primary malignancies in the head and neck region outside of the T and N site or distant metastasis were not counted as an event and were instead treated as competing risks. Per the TNM staging of tumors: T describes the size of the tumor and whether it has invaded nearby tissue, and N describes regional lymph nodes that are involved. Due to the minimal events reported (data cut-off 30-Sep-2010), valid analysis could not be performed for loco-regional control rate.|From the date of randomization until progression in the T or N site or death due to any cause, assessed after a median of 30.9 months|ITT Population|||||
730307|NCT00387127|Secondary|Number of Participants With Loco-regional Recurrence of Initial Disease|Participants with loco-regional recurrence were those who had progression of disease in the T and N sites. Per the Tumor, Node, and Metastases (TNM) staging of tumors: T describes the size of the tumor and whether it has invaded nearby tissue, and N describes regional lymph nodes that are involved. If a participant had progression in the T or N sites, then the participant was counted as having had an event of interest.|From the date of randomization until progression in the T or N site or death due to any cause, assessed after a median of 30.9 months|ITT Population||Participants|||Number
730308|NCT00387127|Secondary|Disease-specific Survival|Disease-specific survival is defined as the time from randomization until death due to head and neck cancer.|From the date of randomization until the date of death due to disease, assessed after a median of 13 months of follow-up|ITT Population. For participants who did not die, time to death was censored at the time of last contact.||Months||Inter-Quartile Range|Median
730309|NCT00387127|Secondary|Number of Participants Who Died Due to Progressive Disease|The number of participants who died due to progressive disease (a >=20% increase in the sum of the longest diameter of target lesions, or the appearance of >=1 new lesion, symptomatic progression and/or unequivocal progression of existing non-target lesions), or died due to head and neck cancer without evidence of disease progression, after randomization in the study is presented, using a data cut of 1 August 2014.|From the date of randomization until the date of death due to disease under study, assessed after a median of 30.9 months|ITT Population||Participants|||Number
730310|NCT00387127|Secondary|Overall Survival (OS)|OS is defined as the time from randomization until death due to any cause. Time to death (data cut-off 1-Aug-2014) was censored at the time of last contact for participants who did not die.|From the date of randomization until the date of death due to any cause, assessed after a median of 30.9 months|ITT Population||Months||95% Confidence Interval|Median
730311|NCT00387127|Secondary|Progression-Free Survival (PFS), as Assessed by the Investigator|PFS=the time from randomization until the earliest date of disease progression or death due to any cause, if sooner. Per RECIST, progressive disease=a >=20% increase in the sum of the longest diameter of target lesions (TLs), or the appearance of >=1 new L, symptomatic progression and/or unequivocal progression of existing non-TLs. For participants who did not progress or die at the time of reporting (data cut-off 1-Aug-2014), PFS data were censored at the time of the last investigator assessed radiological scan preceding the initiation of any alternative anti-cancer therapy.|From the date of randomization until the date of disease progression or death due to any cause, assessed after a median of 22 months of follow-up|ITT Population||Months||95% Confidence Interval|Median
730312|NCT00387127|Secondary|Number of Participants With CR, as Assessed by the Investigator|Participants with CR are defined as those who achieved a complete tumor response at 6 months after the completion of the CRT, as determined by the investigator. Tumor response was assessed using modified RECIST criteria. Per RECIST, CR is defined as the disappearance of all target and non-target lesions. Data are based on Week 24 scans from participants receiving study treatment at that time and on those in follow-up.|From the date of randomization until 6 months post chemoradiation treatment, assessed after a median time of 13 months of follow-up|ITT Population||Participants|||Number
730313|NCT00387127|Primary|Number of Participants (Par.) With Complete Response (CR), as Assessed by Independent Radiological Review|Participants with CR are defined as those who achieved a complete tumor response at 6 months after the completion of the chemoradiation treatment (CRT), as assessed by independent radiological review. Tumor response was assessed using modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Per RECIST, CR is defined as the disappearance of all target and non-target lesions. Data are based on Week 24 scans from participants receiving study treatment at that time and on those in follow-up.|From the date of randomization until 6 months post chemoradiation treatment, assessed for a median time of 13 months|Intent-to-Treat (ITT) Population: all participants who were randomized to study treatment, regardless of whether they actually received study medication||Participants|||Number
730314|NCT00387153|Secondary|Antiproliferative Activity|Observation for any evidence of antiproliferative activity of MPC-2130 in treatment of a variety ofrefractory neoplasias.|Every 42 days||||||
730315|NCT00387153|Primary|Pharmacokinetics|Characterization of MPC-2130 pharmamcokinetics consisting of AUC, tmax, Cmax, half-life and clearance.|First 5 days of treatment (Cycle 1)||||||
730316|NCT00387153|Primary|Number of Subjects With Dose Limiting Toxicities and Grade 3/4 Adverse Events. As a General Guideline, a Severe Adverse Event is Considered Grade 3, and a Life Threatening or Disabling Adverse Event is Considered Grade 4.|"Dose limiting toxicities include any grade 3 nonhematological toxicity(excluding nausea/vomiting or alopecia); greater than grade 3 nausea/vomiting uncontrolled by aggressive antiemetic support; grade 4 neutropenia lasting more than 5 days, or any febrile (38.5° C or 101° F) grade 3/4 neutropenia; grade 4 thrombocytopenia.
An adverse event is any reaction, side effect, or other untoward event, regardless of relationship to MPC-2130 that occurs any time after the beginning of the first IV infusion of MPC-2130 until 30 days after MPC-2130 discontinuation."|First 21 days on treatment (Cycle 1)|A total of 8 subjects were enrolled in the study. Statistical analyses were intended to be descriptive since the goal for the study was to determine the maximum tolerated dose and general safety and tolerability of MPC-2130.||Participants|||Number
730317|NCT00387335|Secondary|Overall Survival|Time from start of treatment until death from any cause.|Up to two years|||weeks||Full Range|Median
730318|NCT00387335|Secondary|Progression-free Survival|Time to disease progression or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Up to 2 years|||weeks||Full Range|Median
730320|NCT00387335|Primary|Objective Tumor Response Rate (Complete Response [CR] and Partial Response [PR]) Using RECIST Criteria|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|While patient remains on treatment, up to 30 weeks|||percentage of participants||95% Confidence Interval|Number
730321|NCT00387348|Primary|Change in Hamilton Depression Rating Scale (HAM-D) Scores|The change in HAM-D scores was calculated by subtracting the score at 4 weeks from the score at baseline. The HAM-D can have total scores that range from 0 to 50, with higher scores indicating greater depression. Scores over 14 are considered to be in the depressed range.|4 weeks|Participants who had at least 1 follow up HAM-D assessment were included. Two participants died, one without a follow up assessment and one with a HAM-D at 2 weeks. For the participant who had the HAM-D at 2 weeks and then died, the last endpoint was carried forward.||Change in HAM-D scores||Standard Deviation|Mean
730322|NCT00387348|Secondary|Side Effect Burden|Side efect burden was defined as the total score of the UKU Side Effects Rating Scale. This scale contains 48 items corresponding to side effects which are rated from 0-3, with 0 meaning not present and 1-3 rating the severity of the side effect. Higher scores represented greater side effect burden. The scale range is 0 to 144.|4 weeks|Participants who completed the 4 week assessment were analyzed||units on a scale||Standard Deviation|Mean
730323|NCT00387348|Primary|Depression Response Rate of Escitalopram Oxalate 10 mg Once Daily Compared to Placebo Once Daily for Major Depressive Disorder|Response rate was defined as a 50% reduction in the Hamilton Depression Rating Scale (HAM-D) scores over 4 weeks. The HAM-D can have total scores that range from 0 to 50, with higher scores indicating greater depression. Scores over 14 are considered to be in the depressed range.|4 weeks|The efficacy analysis was intent to treat and all randomized participants were analyzed||number of participants with response|||Number
730324|NCT00387426|Primary|Number of Participants With Objective Clinical Response to Sunitinib Therapy|Participant response assessed after two cycles of therapy according to categories: 1) complete response, 2) partial response, 3) clinical improvement, 4) stable disease 5) progressive disease, 6) early death from malignant disease, 7) early death from toxicity, 8) early death because of other cause, or 9) unknown (not assessable, insufficient data).|After two 6-week treatment courses (12 weeks)|All participants assessed for response.||participants|||Number
730325|NCT00387621|Primary|Nesiritide Pre-Treatment Urinary cGMP Excretion After Volume Expansion (UcGMPV)|Subjects received subcutaneous Nesiritide in the abdomen. After 15 minutes, the acute saline load (volume expansion, VE) was administered. Subjects were asked to empty bladder spontaneously every 30 min (if unable to void every 30 min, a urinary catheter was placed). Adequate bladder emptying was insured by ultrasonography. UcGMPV was collected at baseline (immediately before VE) and at 30 and 60 min after initiation of VE.|Baseline, 30 min, 60 min|||pmol/min||Standard Deviation|Mean
730326|NCT00387621|Primary|Nesiritide Pre-Treatment Urinary Sodium Excretion After Volume Expansion (UNaV)|Subjects received subcutaneous Nesiritide in the abdomen. After 15 minutes, the acute saline load (volume expansion, VE) was administered. Subjects were asked to empty bladder spontaneously every 30 min (if unable to void every 30 min, a urinary catheter was placed). Adequate bladder emptying was insured by ultrasonography. UNaV was collected at baseline (immediately before VE) and at 30 and 60 min after initiation of VE.|Baseline, 30 min, 60 min|||uEq/min||Standard Deviation|Mean
730327|NCT00387621|Primary|Placebo Pre-Treatment Urinary cGMP Excretion After Volume Expansion (UcGMPV)|Subjects received subcutaneous placebo in the abdomen. After 15 minutes, the acute saline load (volume expansion, VE) was administered. Subjects were asked to empty bladder spontaneously every 30 min (if unable to void every 30 min, a urinary catheter was placed). Adequate bladder emptying was insured by ultrasonography. UcGMPV was collected at baseline (immediately before VE) and at 30 and 60 min after initiation of VE.|Baseline, 30 min, 60 min|||pmol/min||Standard Deviation|Mean
730328|NCT00387621|Primary|Placebo Pre-Treatment Urinary Sodium Excretion After Volume Expansion (UnaV)|Subjects received subcutaneous placebo in the abdomen. After 15 minutes, the acute saline load (volume expansion, VE) was administered. Subjects were asked to empty bladder spontaneously every 30 min (if unable to void every 30 min, a urinary catheter was placed). Adequate bladder emptying was insured by ultrasonography. UNaV was collected at baseline (immediately before VE) and at 30 and 60 min after initiation of VE.|Baseline, 30 min, 60 min|||uEq/min||Standard Deviation|Mean
730329|NCT00387621|Secondary|Change in Urinary Cyclic Guanosine Monophosphate (cGMP) at 60 Minutes in Response to Nesiritide Treatment Compared to Placebo Treatment|Value of cGMP at 60 min on nesiritide treatment minus value of cGMP at 60 min on placebo treatment (per subject group). The baseline was not involved in this calculation.|60 minutes|||pmol/min||Standard Error|Mean
730330|NCT00387621|Secondary|Change in Urinary Cyclic Guanosine Monophosphate (cGMP) at 30 Minutes in Response to Nesiritide Treatment Compared to Placebo Treatment|Value of cGMP at 30 min on nesiritide treatment minus value of cGMP at 30 min on placebo treatment (per subject group). The baseline was not involved in this calculation.|30 minutes|intention to treat (ITT)||pmol/min||Standard Error|Mean
730331|NCT00387621|Secondary|Change in Natriuresis (Urinary Sodium Excretion) at 60 Minutes in Response to Nesiritide Treatment Compared to Placebo Treatment|Value of natriuresis at 60 min on nesiritide treatment minus value of natriuresis at 60 min on placebo treatment (per subject group). The baseline was not involved in this calculation.|60 minutes|intention to treat (ITT)||mEq/min||Standard Error|Mean
730332|NCT00387621|Secondary|Change in Natriuresis (Urinary Sodium Excretion) at 30 Minutes in Response to Nesiritide Treatment Compared to Placebo Treatment|Value of natriuresis at 30 min on nesiritide treatment minus value of natriuresis at 30 min on placebo treatment (per subject group). The baseline was not involved in this calculation.|30 minutes|intention to treat (ITT)||mEq/min||Standard Error|Mean
730333|NCT00387621|Secondary|Change in Urinary Cyclic Guanosine Monophosphate (cGMP) in Control Subjects at 60 Minutes After Volume Expansion Compared to Baseline in Response to Placebo Treatment|Value at 60 minutes minus value at baseline|baseline and 60 minutes|intention to treat (ITT)||pmol/min||Standard Error|Mean
730334|NCT00387621|Primary|Change in Natriuresis (Urinary Sodium Excretion) in Control Subjects at 60 Minutes After Volume Expansion Compared to Baseline in Response to Placebo Treatment|Value at 60 minutes minus value at baseline.|baseline and 60 minutes|per protocol||mEq/min||Standard Error|Mean
730337|NCT00387647|Primary|Rate of Disease Free Survival at One Year|The primary efficacy variable is disease free survival measured at one year, which is the percentage of patients who remain alive and disease free one year after the confirmation of remission by bone marrow biopsy. Relapse is defined by a bone marrow specimen with >5% blasts or the presence of Auer rods.|1 year|All participants||percentage of participants|||Number
730338|NCT00387660|Secondary|Number of Participants With Toxicity|All adverse events were graded according to the National Cancer InstituteCommon Toxicity Criteria, version 2.0. All 80 patients were assessable for toxicity at least for the first cycle.|Up to 36 months|||Participants|||Count of Participants
730339|NCT00387660|Secondary|Median Survival of Patients Treated With This Regimen|The length of time from the start of treatment that half of the patients in a group of patients diagnosed with the disease are still alive.|Up to 36 months|All participants for whom response evaluation measurements were recorded at Baseline and after 2 cycles.||months||95% Confidence Interval|Median
730340|NCT00387660|Primary|Overall Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria for target lesions and assessed by radiographic techniques. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 36 months|All participants for whom response evaluation measurements were recorded at Baseline and after 2 cycles.||percentage of participants|||Number
730341|NCT00387673|Primary|Conduct pre-and Post-training Assessments of Behavioral Outcomes Using Wolf Motor Function Test and Jebsen Taylor Hand Function Test to Measure Upper Extremity Function, Hand-held Dynamometry to Measure Pinch Grip Strength, and Semmes-Weinstein Monofilam||Outcome measures: baseline, 6 weeks after baseline, post testing, 6 weeks post testing|Project has officially closed. PI for this project has left VA without forwarding information.|||||
730342|NCT00387712|Secondary|30 Foot Walk Time (Sec)|Participants are instructed to walk fast as comfortable on a straight pathway on the floor demarcated by cones. They may use their usual canes, walkers, and orthotics while they walk. The walks are timed, the value is the mean of three trials with an interval rest between each trial.|baseline to 6 month|Randomized study design with intent to treat group by time analysis of change in floor walking time between the higher-intensity treadmill training group and the lower intensity training group across baseline to 6 months post-exercise time points.||sec||Standard Error|Mean
730343|NCT00387712|Primary|Paretic Thigh Skeletal Muscle Myosin Heavy Chain Myosin Heavy Chain Isoform 2a|Skeletal muscle punch biopsies are obtained from the bilateral (paretic and non-paretic) vastus lateralis thigh muscle, at baseline and after 6 month interventions. Homogenized muscle messenger ribonucleic acid (mRNA) for myosin heavy chain isoforms are analyzed by real time polymerase chain reaction as fluorescent units with normalization to an acidic ribosomal protein, a housekeeping gene.|Baseline to 6 month|"The difference muscle and participant number reflects those that participated and completed pre/post biopsies.
Paretic thigh muscle, at baseline and after 6 month interventions, are analyzed for myosin heavy chain proportions. Values were the mean of duplicates run on polymerase chain reaction were normalized to a ribosomal protein mRNA."||PCR flourescence units||Standard Error|Mean
730344|NCT00387712|Primary|Cardiovascular Fitness (VO2 Peak)|Cardiovascular fitness is measured by collecting the expired gases during a progressive graded treadmill test.|Baseline to 6 month|Randomized study design with Intent to treat group by time analysis of change in peak cardiovascular fitness levels between the higher-intensity treadmill training group and the lower intensity training group across baseline to 6 months post-exercise time points.||ml/kg/min||Standard Error|Mean
730345|NCT00387725|Primary|Percentage of Participants With at Least One Adverse Event (AE)||Dose 1 up to 1 month after Dose 3|||percentage of participants|||Number
730346|NCT00387725|Primary|Percentage of Participants With Seroconversion in rLP2086 Specific SBA Titer 1 Month After Dose 3||1 month after Dose 3|||percentage of participants|||Number
730347|NCT00387725|Primary|Percentage of Participants With Seroconversion in rLP2086 Specific Serum Bactericidal Assay (SBA) Titer 1 Month After Dose 2||1 month after Dose 2|||percentage of participants|||Number
730348|NCT00387751|Secondary|Survival|Determined by time to progression, progression-free suvival, and overall survival.|6 months||||||
730349|NCT00387751|Secondary|Safety and Tolerability|Safety and tolerability of treatment, in terms of toxicity profile and incidence and rating of toxicity, according to NCI CTCAE v3.0 criteria.|6 months||||||
730350|NCT00387751|Primary|Response|"Clinical biologic activity of treatment, defined as the sum of complete response, partial response, and prolonged stable disease for ≥ 16 weeks, upon treatment with the combination of sorafenib and bevacizumab, in patients with advanced metastatic melanoma previously treated with immunotherapy or in previously untreated patients who are not appropriate candidates to receive IL-2-based treatment.
Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started of the appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started."|4 months|||participants|||Number
730351|NCT00387764|Secondary|Percentage of Participants Who Survived Until Month 12|For participants who did not die, time to death was censored at the time of last contact. The last date of contact was defined as the maximum date of any visit date or the survival follow-up date.|From the first dose of study medication to Month 12|ATS Population||Percentage of participants|||Number
730352|NCT00387764|Secondary|Overall Survival (OS)|OS is defined as the interval between the date of the first dose of study medication to the date of death due to any cause. For participants who did not die, time to death was censored at the time of last contact. The last date of contact was defined as the maximum date of any visit date or the survival follow-up date.|From the first dose of study medication to the earliest date of disease progression (PD) or death due to any cause (up to 3.460 years)|ATS Population||months||95% Confidence Interval|Median
730373|NCT00387881|Secondary|Intermediate Sustained Pain-Free: Post-dose at Intervals of 2-4 Hours and 1-2 Hours|Intermediate sustained pain free was defined as achieving headache pain-free (moderate or severe pain to no pain) prior to the specified timepoint (1 or 2 hours) and maintaining it to the specified timepoint (2-4 hours).(Intermediate=Intermed.)|1-2 and 2-4 hours after treatment|ITT Population||Participants|||Number
730353|NCT00387764|Secondary|Progression-free Survival (PFS)|PFS is defined as the interval between the date of the first dose of study medication and the date of disease progression as defined by the investigator or death due to any cause. RECIST was used to evaluate the measurability of tumor lesions, to determine target and non-target lesions at Baseline, and to evaluate tumor response or disease progression after study start. Per RECIST, PD is defined as at least a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum of the LD recorded since the treatment started or the appearance of >=1 new lesion and/or unequivocal progression of existing non-target lesions. Participants who did not have disease progression or did not die were censored at the follow-up visit as either follow-up ended or follow-up ongoing. Participants who received non-study anti-cancer therapies before disease progression were treated as censored.|From the first dose of study medication to the earliest date of disease progression (PD) or death due to any cause (up to 3.460 years)|ATS Population||months||95% Confidence Interval|Median
730354|NCT00387764|Secondary|Number of Participants With the Indicated Best Overall Response|The best overall response is defined as the best response recorded from the start of the treatment until disease progression (PD)/recurrence. Per RECIST: CR, the disappearance of all target and non-target lesions; PR, at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD; SD, neither sufficient shrinkage in target lesions to qualify for PR, nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started and the persistence of one or more non-target lesion(s); PD, at least a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum of the LD recorded since the treatment started or the appearance of >=1 new lesion and/or unequivocal progression of existing non-target lesions. Unknown/not evaluable is used for those participants who cannot be classified as achieving CR, PR, SD, or PD.|From the Baseline to Week 24/investigational product discontinuation (up to 3.460 years)|ATS Population||participants|||Number
730355|NCT00387764|Secondary|Number of Participants With a Response of Confirmed CR+PR+6-month Stable Disease (SD)|The number of participants who achieved either a CR, a PR, or a best response of SD that occurred at least 6 months after screening per RECIST criteria was assessed. CR is defined as the disappearance of all target and non-target lesions; PR is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD; and SD is defined as neither sufficient shrinkage in target lesions to qualify for PR, nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started and the persistence of one or more non-target lesion(s), as assessed by the investigator. Confirmation of a CR/PR required a subsequent assessment of the same response or better at least 28 days after the original response. A confirmed response of SD required that the SD assessment occurred no earlier than 12 weeks after the screening scans.|From the Baseline to Week 24/investigational product discontinuation (up to 1.65 years)|ATS Population. An analysis was performed on 71 participants.||participants|||Number
730356|NCT00387764|Secondary|Number of Participants With a Complete Response (CR) or Partial Response (PR)|Overall tumor response is defined as the number of participants achieving either a confirmed complete or partial tumor response per Response Evaluation Criteria in Solid Tumors (RECIST). RECIST guidelines were used to evaluate the measurability of tumor lesions, to determine target and non-target lesions at Baseline, and to evaluate tumor response or disease progression after study start. CR is defined as the disappearance of all target and non-target lesions, and PR is defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions, taking as a reference the Baseline sum LD, as assessed by the investigator. Confirmation of a CR/PR required a subsequent assessment of the same response or better at least 28 days after the original response.|From Baseline to Week 24/investigational product discontinuation (up to 3.460 years)|ATS Population||participants|||Number
730357|NCT00387764|Primary|Number of Participants With a Change From Baseline to the Indicated Worst-case Post-Baseline Bazett's Heart Rate-corrected QT Interval (QTc) Value|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. A lengthened QT interval can be a biomarker for ventricular tachyarrhythmias. The QT interval corrected for heart rate using Bazett’s formula (QTcB) was calculated; the faster the heart rate, the shorter the QT interval. Electrocardiogram values (Bazett’s QTc value) were summarized using the following reference ranges: <450, 450 to 479, 480 to 499, 500 to 549, and >550 milliseconds.|From Baseline to investigational product discontinuation (up to 6.230 years)|ATS Population. Only those participants available at the specified time points were analyzed; 3 participants did not have post-Baseline results.||participants|||Number
730358|NCT00387764|Primary|Number of Participants With the Indicated Shift in Heart Rate From Baseline at Any Time Post-Baseline|Heart rate is the measure of heart beats per minute (bpm). The number of participants with a post-Baseline shift from Baseline in heart rate of <44 bpm, 44 to 100 bpm, 101 to 120 bpm, and >120 bpm was assessed.|From Baseline to investigational product discontinuation (up to 6.230 years)|ATS Population. Only those participants available at the specified time points were analyzed.||participants|||Number
730359|NCT00387764|Primary|Number of Participants With the Indicated Shift From Baseline in Blood Pressure at Any Time Post-Baseline|Blood pressure measurements included systolic blood pressure (SBP, millimeters of mercury [mmHg]) and diastolic BP (DBP). The number of participants with a post-Baseline shift from Baseline in blood pressure (<90 mmHg, 90 to 139 mmHg, 140 to 169 mmHg, >=170 mmHg) was assessed.|From Baseline to investigational product discontinuation (up to 6.230 years)|ATS Population||participants|||Number
730360|NCT00387764|Primary|Number of Participants With the Indicated Worst-case Grade Increase From Baseline for the Indicated Hematology Parameters at Any Time Post-Baseline|Hematology parameters were summarized according to NIH CTCAE, version 4.0. Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling; Grade 5, death. Data are presented for only those parameters for which an increase from Baseline occurred. Hematology parameters included: hemoglobin (anemia), lymphocytes (lymphocytopenia), neutrophils (neutropenia), platelets (thrombocytopenia), white blood cells (WBC [leukopenia]), and prothrombin time international normalized ratio (PT [INR]). Participants with missing Baseline grades are assumed to have a Baseline grade of 0.|From Baseline to investigational product discontinuation (up to 6.230 years)|ATS Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ATS Population.||participants|||Number
730361|NCT00387764|Primary|Number of Participants With the Indicated Worst-case Toxicity Grade Increase From Baseline for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline|Clinical chemistry parameters were summarized according to NCI CTCAE, version 4.0: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling; Grade 5, death. Data are presented for only those parameters for which an increase from Baseline occurred. Clinical chemistry parameters included: alkaline phosphatase (ALP), alanine amino transferase (ALT), aspartate amino transferase (AST), total bilirubin (TB), calcium (hypercalcemia and hypocalcemia), creatinine, glucose (hyperglycemia and hypoglycemia), potassium (hyperkalemia and hypokalemia), magnesium (hypermagnesemia and hypomagnesemia), sodium (hypernatremia and hyponatremia), and phosphate.|From Baseline to investigational product discontinuation (up to 6.230 years)|ATS Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ATS Population.||participants|||Number
730362|NCT00387764|Primary|Median Time on Investigational Product|The time on investigational product (including dose interruptions) is defined as the difference between the date of the last dose of investigational product and the date of the first dose of investigational product plus one.|From Baseline to investigational product discontinuation (up to 6.230 years)|ATS Population||Months||Inter-Quartile Range|Median
730363|NCT00387764|Primary|Number of Participants With Adverse Events Related to Investigational Product|An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The investigator assessed relatedness between the AE and the investigational product.|From Baseline to Follow-up (up to 6.230 years)|ATS Population||participants|||Number
730364|NCT00387764|Primary|Number of Participants With Any Adverse Event (Serious and Non-serious) of the Indicated Severity, Per National Cancer Institute (NCI) Common Terminology Criteria in Adverse Events (CTCAE)|An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in other situations. Adverse events were graded for severity according to the NCI CTCAE, version 3.0: Grade 1, mild; Grade 2, moderate; Grade 3 (G3), severe; Grade 4 (G4), life-threatening or disabling; Grade 5, death.|From Baseline to Follow-up (up to 6.230 years)|ATP Population||participants|||Number
730365|NCT00387764|Primary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in other situations.|From Baseline to Follow-up (up to 6.230 years)|All Treated Participants (ATP) Population: all enrolled participants who received at least one dose of open-label investigational product||participants|||Number
730366|NCT00387790|Secondary|Occurrence of Serious Toxicity|Occurrence of serious toxicity defined as any grade 4 hematologic toxicity that persists for more than 7 days or requires platelet transfusions for a time period exceeding 7 days; any grade 3 or 4 non-hematologic toxicity with the exception of grade 3 nausea or vomiting which can be controlled within 7 days; grade 3 skin reaction; grade 3 transaminitis.|Up to 1 year after enrollment||||||
730367|NCT00387790|Secondary|One Year Overall Survival||Time to death from any cause, assessed up to 1 year after enrollment||||||
730368|NCT00387790|Primary|One Year Event-free Survival (EFS)||Time to disease progression, disease relapse, occurrence of a second neoplasm, or death from any cause, assessed up to 1 year after enrollment.|Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome. The 2 patients who are ineligible were excluded from the Outcome Measure analysis.||participants|||Number
730369|NCT00387829|Secondary|Radiological, Pain, and Functional Outcome Assessments|"Radiological score (MRI Outcome score): MRI peridural fibrosis in 5 consecutive 2-D axial Spin Echo T1 axial slices. Score consists of the ratio of total available space in each image and the amount of scar identified (percentage).
Pain (VAS): Visual Analog Score used to rate the subject’s pain.VAS scale is a 100 mm horizontal line, where the far left side of the scale equals (0) no pain and the far right side of the scale (100) equals the worst possible pain.
Functional outcome score (ODI): Used to assess the effect leg or back pain on everyday life. Questions relate to areas such as walking, lifting, sitting, ability to travel as well as other common activities. Ten questions with scores from 0-5. Calculated as percentage: (Actual score /Maximum overall score (worst disability))*100."|12 months|Data reported for patients evaluable at 12 months.||Outcome scores||Standard Error|Least Squares Mean
730370|NCT00387829|Primary|Radiological, Pain, and Functional Outcome Assessments|"Radiological score (MRI Outcome score): MRI peridural fibrosis in 5 consecutive 2-D axial Spin Echo T1 axial slices. Score consists of the ratio of total available space in each image and the amount of scar identified (percentage).
Pain (VAS): Visual Analog Score used to rate the subject’s pain.VAS scale is a 100 mm horizontal line, where the far left side of the scale equals (0) no pain and the far right side of the scale (100) equals the worst possible pain.
Functional outcome score (ODI): Used to assess the effect leg or back pain on everyday life. Questions relate to areas such as walking, lifting, sitting, ability to travel as well as other common activities. Ten questions with scores from 0-5. Calculated as percentage: (Actual score /Maximum overall score (worst disability))*100."|6 months|Data reported for patients evaluable at 6 months.||Outcome scores||Standard Error|Least Squares Mean
730371|NCT00387881|Secondary|Medication Satisfaction: Mean Patient Perception of Migraine (PPMQ-R) Subscale Score|Patient Perception of Migraine Questionnaire-Revised(PPMQ-R) evaluates subject satisfaction with treatment 24 hours post-dose using validated questions. Questions are analyzed on 4 subscale scores (efficacy, functionality, ease-of-use, and tolerability) and total score. Scores range from 0-100, with the higher scores indicating better satisfaction.|0 - 24 hours after treatment|ITT Population - Actual numbers of subjects who took questionnaire were Placebo 199 and Sumatriptan/Naproxen=188||Score in scale||Standard Error|Mean
730374|NCT00387881|Secondary|Intermediate Sustained Pain Relief: Post-dose at Intervals of 2-4 Hours and 1-2 Hours After Treatment|Intermediate sustained pain relief was defined as achieving headache pain relief (from moderate or severe pain at baseline to mild or no pain) prior to the specified timepoint (1 or 2 hours) and maintaining it to the specified timepoint (2-4 hours). (Intermediate=Intermed.)|1-2, and 2- 4 hours after treatment|ITT Population||Participants|||Number
730375|NCT00387881|Secondary|Subjects Who Used Rescue Medication From 0 - 24 Hours After Treatment|Rescue medication defined as additional medication (i.e. sumatriptan/naproxen sodium as open-label rescue or other medication as permitted per protocol), taken by subject for the treatment of headache pain or other symptoms associated with the headache attack.|0 - 24 hours after treatment|ITT Population||Participants|||Number
730376|NCT00387881|Secondary|Headache Relief at 4, 2, 1 and 0.5 Hours After Treatment|Pain relief was defined as reduction of headache pain from a baseline severity of moderate or severe to none or mild at the given time.|0.5, 1, 2, and 4 hours after treatment|ITT Population||Participants|||Number
730377|NCT00387881|Secondary|Sustained Headache Relief 2-24 Hours After Treatment|Sustained pain relief was defined as having pain relief (mild or no pain) at 2 hours w/o any moderate or severe pain during 2-24 hour period post-treatment, without rescue medication.|2-24 hours after treatment|ITT Population||Participants|||Number
730378|NCT00387881|Secondary|Freedom From Headache Pain at 0.5, 1, and 4 Hours After Treatment|Pain-Free is defined as post-treatment headache pain severity of none in subjects who have not used rescue medication prior to or at the time of the assessment.|0.5, 1, and 4 hours after Treatment|ITT Population||Participants|||Number
730379|NCT00387881|Primary|Pain-Free at 2 Hours Post-dose and Sustained Pain-Free From 2-24 Hours Post-dose.|Pain-free was defined as a headache severity of no pain (grade 0) at 2 hours post-treatment in subjects who have not used rescue medication prior to or at the time of the assessment. Sustained pain-free response was defined as pain-free at 2 hours post-treatment through 24 hours post-treatment without rescue medicine.|2 hours through 24 hours after Treatment|The Intent to Treat (ITT) Population was the primary analysis population for assessing efficacy and included subjects who treated at least 1 headache attack with randomized treatment and provided at least one post dose evaluation.||Participants|||Number
730380|NCT00387894|Secondary|Duration of Progress-free Survival (PFS)|Patients with stable or responding disease will continue treatment until tumor progression is determined|Until first observation of progressive disease, non-reversible neurologic progression or permanently increased steroid requirement (stable disease only), death due to any cause (up to 16 weeks)|||participants|||Number
730381|NCT00387894|Primary|Disease Response Measured Objectively by MRI of Brain|Lack of disease progression indicates response to treatment|Every 8 weeks or as indicated|5 participants evaluable while receiving study treatment||participants|||Number
730382|NCT00387959|Primary|Survival at 1 Year After Transplantation|The number of patients survival status 1 year after transplantation|1 Year after transplant|||participants|||Number
730383|NCT00388037|Primary|Objective Response (Partial Response or Complete Response) as Per the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria|Partial response is defined as a 30% decrease in the sum of the longest diameters of the target lesion maintained for at least 4 weeks; complete response is defined as complete disappearance of disease and cancer related symptoms maintained for at least 4 weeks. The 95% confidence interval for response rate will be calculated. The median and range of the duration of response will be assessed.|Up to 3 years|All response evaluable patients||percentage of evalubale patients||95% Confidence Interval|Number
730384|NCT00388154|Primary|Overall Objective Response Rate (CR + PR)|Objective response (OR) defined as percentage of participants with RECIST Complete Response (CR) and Partial Response (PR), defined as CR: Disappearance all target and non-target lesions, no evidence of new lesions documented by 2 disease assessments at least 4 weeks apart. Normalization of CA-125, if elevated at baseline, is required; PR: 30% decrease in sum of longest dimensions (LD) of all target measurable lesions reference baseline sum of LD, no unequivocal progression of non-target lesions; no new lesions documented by 2 disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical examination, which is not radiographically measurable, a 50% decrease in the LD is required. 21-day cycle assessments or until either disease progression or adverse effects prohibit further treatment.|Responses required confirmation by imaging after 4-week+ interval following 3 week (21 day) therapy course.|Participants who received one or more course(s) of chemotherapy and survived at least 4 weeks were considered evaluable for response; One participant was not evaluable.||percentage of participants|||Number
730385|NCT00388154|Primary|Participant Responses|Response Evaluation Criteria In Solid Tumors (RECIST): Complete Response (CR): disappearance all target & nontarget lesions, absence new lesions, documented by 2 disease assessments 4 weeks apart; Partial response (PR): 30% decrease in sum longest diameter (LD) all measurable target lesions (baseline sum LDs as reference) & absence of progression of nontarget lesions or development of new, documented by 2 disease assessments 4 weeks apart. When only target lesion solitary pelvic mass measurable by physical examination but not radiography, a 50% decrease in LD required to be PR; Progressive disease (PD): 20% increase in sum LDs of target lesions (reference smallest sum of LDs at any assessment) or appearance of new lesions within 9 weeks of study entry, and unequivocal progression of existing nontarget lesions, other than pleural effusions without cytological proof of neoplastic origin within 9 weeks of enrollment; Stable disease (SD): any condition not meeting above CR, PR, or PD.|Responses required confirmation by imaging after 4-week+ interval following 3 week (21 day) therapy course.|Participants who received one or more course(s) of chemotherapy and survived at least 4 weeks were considered evaluable for response; One participant was not evaluable.||participants|||Number
730386|NCT00388349|Secondary|Survival Measures|"Reports the survival measures:
Freedom from progression (FFP)
Event-free survival (EFS)
Overall survival (OS)
EFS and OS were estimated by Kaplan-Meier method
Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions"|2 years|Lists the results as included in the publication, which included 92 participants who received the MTD treatment; completed the study; and had all data points collected||percentage of patients||95% Confidence Interval|Number
730387|NCT00388349|Secondary|Relapse Post-transplant|Reports the percentage of participants that experienced relapse post-transplant.|2 years|All participants||percentage of participants|||Number
730389|NCT00388349|Secondary|Pulmonary Toxicity (BCNU Pneumonitis)|Pulmonary toxicity as assessed by the number of participants that experience BCNU pneumonitis, ie, pneumonitis due to carmustine (BCNU).|2 years|Patients who completed the study regardless of gemcitabine dose, and had all data points collected.||participants|||Number
730390|NCT00388349|Primary|Dose-limiting Toxicity of Gemcitabine Due to Non-hematologic Toxicity|Reported as the number of Phase 1 participants by gemcitabine dose that experienced non-hematologic toxicity, ie, drug-related adverse events.|6 months|7 patients received 1 of 2 dose levels during the Phase 1 dose-escalation component of the study||participants|||Number
730391|NCT00388362|Secondary|Overall Survival|Administration of Sirolimus and Prednisone|3 month intervals after the initiation of sirolimus until 2 years after the initiation of sirolimus|23 patients that remained on the study for a median of 514 days (96-814 days), 2 died (1- second cancer and 1- progressive cardiac failure)||participants|||Number
730392|NCT00388362|Primary|Clinical Activity|Determined by discontinuation of immunosuppression with resolution of all reversible CGVHD manifestations. Evaluated at 2 years after enrollment|3 month intervals after the initiation of sirolimus until 2 years after the initiation of sirolimus|23 patients that remained on the study for a median of 514 days (96-814 days). Numbers based on resolution/ improvement in clinical manifestations of cGVHD with a median of 90% reduction in prednisone dose and no additional immunosuppressive therapy over a two year treatment period.||participants|||Number
730393|NCT00388453|Secondary|Number of Reflux Events|Reflux event was calculated for a drop in pH from baseline to <6 and each event had to last more than 5 seconds and could not be during the meals.|24 hours|||reflux events||Inter-Quartile Range|Median
730394|NCT00388453|Primary|Decrease in pH From Baseline to <6|The three study groups underwent dual pH measurements of the oropharyngeal as well as esophageal acid exposure employing the regular length probe for the oropharynx and the custom-designed long probe for the distal esophagus. The reason for the custom-designed esophageal measurement was to ensure that events noted in the oropharynx originated distally and were of gastric source. Measurements for the two locations were time synchronized to ensure accuracy. Calculations were based on length of time spent in upright and supine positions, and a combination of the two positions. Reflux event was calculated for a drop in pH from baseline to either <4, or <5, or <6 and each event had to last more than 5 seconds and could not be during the meals.|24 hours|Calculations were based on length of time spent in upright and supine positions, and a combination of the two positions. Reflux event was calculated for a drop in pH from baseline to either <4, or <5, or <6 and each event had to last more than 5 seconds and could not be during the meals.||distal esophagus total % time pH <6||Inter-Quartile Range|Median
730395|NCT00388453|Primary|Decrease in pH From Baseline to <5|The three study groups underwent dual pH measurements of the oropharyngeal as well as esophageal acid exposure employing the regular length probe for the oropharynx and the custom-designed long probe for the distal esophagus. The reason for the custom-designed esophageal measurement was to ensure that events noted in the oropharynx originated distally and were of gastric source. Measurements for the two locations were time synchronized to ensure accuracy. Calculations were based on length of time spent in upright and supine positions, and a combination of the two positions. Reflux event was calculated for a drop in pH from baseline to either <4, or <5, or <6 and each event had to last more than 5 seconds and could not be during the meals.|24 hours|Calculations were based on length of time spent in upright and supine positions, and a combination of the two positions. Reflux event was calculated for a drop in pH from baseline to either <4, or <5, or <6 and each event had to last more than 5 seconds and could not be during the meals.||distal esophagus total % time pH <5||Inter-Quartile Range|Median
730396|NCT00388453|Primary|Decrease in pH From Baseline to <4|The three study groups underwent dual pH measurements of the oropharyngeal as well as esophageal acid exposure employing the regular length probe for the oropharynx and the custom-designed long probe for the distal esophagus. The reason for the custom-designed esophageal measurement was to ensure that events noted in the oropharynx originated distally and were of gastric source. Measurements for the two locations were time synchronized to ensure accuracy. Calculations were based on length of time spent in upright and supine positions, and a combination of the two positions.|24 hours|Calculations were based on length of time spent in upright and supine positions, and a combination of the two positions.||distal esophagus total % time pH <4||Inter-Quartile Range|Median
730397|NCT00388505|Secondary|Hospitalization Due to Respiratory Events During the Study|The average number of days patients were hospitalized due to respiratory events during the course of the study.|25 Weeks|Patients in the intent-to-treat population who were hospitalized due to respiratory events.||days||Standard Deviation|Mean
730398|NCT00388505|Secondary|Antipseudomonal Antibiotic Usage During the Study|The average number of days patients required antipseudomonal antibiotics during the course of the study.|25 Weeks|Patients in the intent-to-treat population who required antipseudomonal antibiotics.||days||Standard Deviation|Mean
730399|NCT00388505|Secondary|Change From Baseline in Tobramycin Minimum Inhibitory Concentration|The minimum inhibitory concentration (MIC) is the lowest concentration of an antimicrobial that will inhibit the visible growth of a microorganism after overnight incubation. The MIC of tobramycin against total Pseudomonas aeruginosa colonization was assessed over the course of the study.|Baseline and Day 28 of Cycles 1, 2 and 3 (Weeks 5, 13 and 21) and Final Visit (Week 25)|Intent to treat population for patients with available data. For Final Visit, the last available post-baseline measurement is reported.||μg/mL||Standard Deviation|Mean
730400|NCT00388505|Secondary|Change From Baseline in Pseudomonas Aeruginosa Sputum Density|Three Pseudomonas aeruginosa biotypes were assessed in patient’s sputum; mucoid, dry and small colony variant. Overall density is defined as the sum of all bio-types in Pseudomonas aeruginosa density.|Baseline and Day 28 of Cycles 1, 2 and 3 (Weeks 5, 13 and 21) and Final Visit (Week 25).|Intent to treat population for patients with available data. For Final Visit, the last available post-baseline measurement is reported.||log10 Colony forming units/g||Standard Deviation|Mean
730416|NCT00394888|Primary|Frequency of Hepatic Hemangiomas Detected Via Abdominal Ultrasound|The number of participants with multiple (greater than or equal to 5) cutaneous infantile hemangiomas who were found to have hepatic hemangiomas via the us abdominal ultrasound.|2 years|Subjects enrolled in the hepatic hemangioma arm (n= 151) were analyzed for this outcome measure.||Participants|||Number
730437|NCT00394901|Primary|Mean Pain Scores at Week 11|Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.|Week 11|Full analysis set. Observed case.||score on scale||Standard Error|Least Squares Mean
730401|NCT00388505|Secondary|Patient Satisfaction Assessed Using the Treatment Satisfaction Questionnaire for Medication|Patient’s self-reported treatment satisfaction was measured using the Treatment Satisfaction Questionnaire for Medication (TSQM, a validated instrument) which was modified by adding four study-specific questions; the standard fourteen questions of the TSQM were not altered. Responses to nearly all items are rated on a five-point or seven-point rating scale and the items are factored into 4 domains. The TSQM domain scores range from 0 to 100 with higher scores representing higher satisfaction for that domain.|Day 28 of Cycles 1, 2 and 3 (Weeks 5, 13 and 21).|Intent-to-treat population for whom data were available.||Scores on a scale||Standard Deviation|Mean
730402|NCT00388505|Secondary|Relative Change From Baseline in Percent Predicted Forced Expiratory Volume in One Second (%FEV1)|"Forced expiratory volume in one second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEV1 is then converted to a percentage of normal (percent predicted) based on height, weight, and race. FEV1 was measured at Baseline (prior to beginning study treatment) and predose on Day 28 of Cycles 1, 2 and 3 and at the follow-up visit.
Relative change = 100 * ((Day 28 of Cycle 3 value – Baseline value)/ Baseline value)."|Baseline and Day 28 of Cycles 1, 2 and 3 (Weeks 5, 13 and 21) and Final Visit (Week 25)|Intent to treat population for patients with available data. For Final Visit, the last available post-baseline measurement is reported.||percent of predicted||Standard Deviation|Mean
730403|NCT00388505|Secondary|Percentage of Participants With a Decrease From Baseline in Auditory Acuity|Audiology testing was performed only at selected centers. Auditory acuity was measured from 250 to 8000 Hertz using a standard dual-channel audiometer.|Baseline and Day 28 of Cycles 1, 2 and 3 (Weeks 5, 13 and 21)|Audiology subpopulation||percentage of participants|||Number
730404|NCT00388505|Secondary|Serum Tobramycin Concentrations|Serum tobramycin concentrations were measured in a subset of participants at Week 1 (start of cycle 1), Week 5 (End of Cycle 1), Week 17 (start of cycle 3) and Week 21 (end of cycle 3). Serum samples were collected at pre-dose and post-dose at specified intervals; one specimen between 0 to 2 hours; two additional specimens between 2 and 5 hours (sample times must have been a minimum of 2 hours apart).|Weeks 1, 5, 17 and 21|Pharmacokinetic subpopulation||μg/mL||Standard Deviation|Mean
730405|NCT00388505|Primary|Number of Participants With Treatment-emergent Adverse Events|An adverse event (AE) is any untoward medical occurrence, including any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication that does not necessarily have a causal relationship with study medication. A serious AE (SAE) is an event that results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability, is a congenital anomaly or defect, or is a significant medical event that may jeopardize the patient or require intervention to prevent one of the outcomes listed above.|25 weeks|All Randomized Safety population.||participants|||Number
730406|NCT00388583|Secondary|Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine|"Solicited injection site reactions: Pain, Erythema, Swelling, Induration, Ecchymosis, and Pruritus.
Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia."|Day 0 up to 7 days post-vaccination|Safety analysis was on all enrolled and vaccinated participants, intend-to-treat population||Participants|||Number
730407|NCT00388583|Primary|Number of Participants Who Achieved Seroprotection Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine.|Seroprotection was defined as a post-vaccination Hemagglutinin inhibition (HAI) antibody titer ≥ 40|Day 28 post-vaccination|Immunogenicity determination was in all per protocol population||Participants|||Number
730408|NCT00388583|Secondary|Geometric Mean Antibody Titers (GMTs) Before and Post-vaccination With Either Fluzone Intradermal and Fluzone Intramuscular Vaccine.|The serological determinations of total anti influenza antibodies were performed using an Hemagglutinin inhibition (HAI) test.|Pre- and Day 28 post-vaccination|Immunogenicity determination was in all per protocol population||Titers||95% Confidence Interval|Geometric Mean
730409|NCT00388583|Primary|Number of Participants With at Least a 4-Fold Increase in Serum HAI Antibody Titer Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine.|The serological determinations of total anti-influenza antibodies were performed using an Hemagglutinin inhibition (HAI) test.|Pre-vaccination and Day 28 post-vaccination|Immunogenicity determination was in all per protocol population||Participants|||Number
730410|NCT00388726|Secondary|Safety Parameters: Adverse Events (AEs), Laboratory Parameters, Concomitant Medication, Electrocardiograms (ECGs), and Study Drug Exposure.||AEs and conmeds – until study termination; lab tests – Day 1 and weekly until study termination; ECGs - Day 1 and at study termination.||||||
730411|NCT00388726|Secondary|Duration of Response.|As measured by RECIST criteria and defined as the time from the first documented CR or PR until disease progression or death from any cause.|From first documented CR or PR until disease progression or death.|Response Evaluable Population||Days||Full Range|Median
730412|NCT00388726|Secondary|Best Overall Response|Measured by RECIST criteria and defined as the best response from the start of treatment until disease progression or recurrence. Lesions measured by computed tomography (CT) scan and magnetic resonance imaging (MRI). Objective response rate: complete response (CR-disappearance of all lesions)+ partial response (PR-30% decrease in lesion diameter), Progressive Disease (PD-20% increase in lesion diameter), stable disease (SD-neither shrinkage nor increase of lesions).|Until Day 30 or every 3 months during Follow-up period for patients who complete study without PD.|Response Evaluable Population||Percent of Participants|||Number
730413|NCT00388726|Secondary|Progression-Free Survival.|Measured using Response Evaluation Criteria in Solid Tumors (RECIST) and defined as the time from the date of randomization until progressive disease or death from any cause in the absence of of progressive disease.|Until disease progression or death.|Intent to Treat||Days||Full Range|Median
730414|NCT00388726|Primary|Overall Survival|Defined as the time from the date of randomization until the date of death from any cause.|From date of randomization until death from any cause|Intent to Treat||Days||Full Range|Median
730415|NCT00388804|Primary|Prostate Specific Antigen (PSA) Failures|Baseline + Post-radiation PSA levels at three month intervals for initial two years then every 6 months thereafter. Participants with a rising PSA and no evidence of local or distant recurrence considered PSA failures.|3 months up to 2 years|One person was not treated and therefore excluded from the analysis.||participants|||Number
730417|NCT00394888|Primary|Cardiac Abnormalities Detected Via Clinical Examination|The number of subjects with clinically definite PHACE syndrome who were identified as having cardiac abnormalities following clinical examination.|2 years|Subjects diagnosed with clinically definite PHACE syndrome, enrolled in the large facial hemangioma arm (n= 33) were analyzed for this outcome measure.||Participants|||Number
730418|NCT00394888|Primary|Cerebrovascular and Structural Brain Abnormalities|The number of PHACE subjects identified with cerebrovascular and/or structural brain abnormalities detected using MRI.|2 years|Subjects diagnosed with clinically definite PHACE syndrome, enrolled in the large facial hemangioma arm (n= 33) were analyzed for this outcome measure.||Participants|||Number
730419|NCT00394888|Primary|Spinal Abnormalities|The number of lumbrosacral hemangioma subjects with confirmed spinal abnormalities detected via lumbrosacral MRI.|2 years|Subjects enrolled in the lumbrosacral hemangioma arm (n= 48) were analyzed for this outcome measure||Participants|||Number
730420|NCT00394888|Primary|Clinical Diagnosis of PHACE Syndrome|For subjects in the large facial hemangioma arm of the study, a clinical assessment by trained physicians was conducted to determine whether or not each subject met diagnostic criteria for PHACE syndrome.|2 years|Subjects enrolled in the large facial hemangioma arm (n= 108) were analyzed for this outcome measure.||Participants|||Number
730421|NCT00394888|Primary|MRI/MRA of Head/Neck/Chest.||2 years|||participants|||Number
730422|NCT00394901|Secondary|Mean Sleep Interference Scores at Week 13|Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.|week 13|Full analysis set. Observed case.||score on scale||Standard Error|Least Squares Mean
730423|NCT00394901|Secondary|Mean Sleep Interference Scores at Week 12|Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.|week 12|Full analysis set. Observed case.||score on scale||Standard Error|Least Squares Mean
730424|NCT00394901|Secondary|Mean Sleep Interference Scores at Week 11|Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.|week 11|Full analysis set. Observed case.||score on scale||Standard Error|Least Squares Mean
730425|NCT00394901|Secondary|Mean Sleep Interference Scores at Week 10|Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.|week 10|Full analysis set. Observed case.||score on scale||Standard Error|Least Squares Mean
730426|NCT00394901|Secondary|Mean Sleep Interference Scores at Week 9|Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.|week 9|Full analysis set. Observed case.||score on scale||Standard Error|Least Squares Mean
730427|NCT00394901|Secondary|Mean Sleep Interference Scores at Week 8|Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.|week 8|Full analysis set. Observed case.||score on scale||Standard Error|Least Squares Mean
730428|NCT00394901|Secondary|Mean Sleep Interference Scores at Week 7|Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.|week 7|Full analysis set. Observed case.||score on scale||Standard Error|Least Squares Mean
730429|NCT00394901|Secondary|Mean Sleep Interference Scores at Week 6|Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.|week 6|Full analysis set. Observed case.||score on scale||Standard Error|Least Squares Mean
730430|NCT00394901|Secondary|Mean Sleep Interference Scores at Week 5|Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.|week 5|Full analysis set. Observed case.||score on scale||Standard Error|Least Squares Mean
730431|NCT00394901|Secondary|Mean Sleep Interference Scores at Week 4|Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.|week 4|Full analysis set. Observed case.||score on scale||Standard Error|Least Squares Mean
730432|NCT00394901|Secondary|Mean Sleep Interference Scores at Week 3|Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.|week 3|Full analysis set. Observed case.||score on scale||Standard Error|Least Squares Mean
730433|NCT00394901|Secondary|Mean Sleep Interference Scores at Week 2|Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.|week 2|Full analysis set. Observed case.||score on scale||Standard Error|Least Squares Mean
730434|NCT00394901|Secondary|Mean Sleep Interference Scores at Week 1|Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.|week 1|Full analysis set. Observed case.||score on scale||Standard Error|Least Squares Mean
730435|NCT00394901|Primary|Mean Pain Scores at Week 13|Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.|Week 13|Full analysis set. Observed case.||score on scale||Standard Error|Least Squares Mean
730436|NCT00394901|Primary|Mean Pain Scores at Week 12|Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.|Week 12|Full analysis set. Observed case.||score on scale||Standard Error|Least Squares Mean
730438|NCT00394901|Primary|Mean Pain Scores at Week 10|Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.|Week 10|Full analysis set. Observed case.||score on scale||Standard Error|Least Squares Mean
730439|NCT00394901|Primary|Mean Pain Scores at Week 9|Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.|Week 9|Full analysis set. Observed case.||score on scale||Standard Error|Least Squares Mean
730440|NCT00394901|Primary|Mean Pain Scores at Week 8|Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.|Week 8|Full analysis set. Observed case.||score on scale||Standard Error|Least Squares Mean
730441|NCT00394901|Primary|Mean Pain Scores at Week 7|Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.|Week 7|Full analysis set. Observed case.||score on scale||Standard Error|Least Squares Mean
730442|NCT00394901|Primary|Mean Pain Scores at Week 6|Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.|Week 6|Full analysis set. Observed case.||score on scale||Standard Error|Least Squares Mean
730443|NCT00394901|Primary|Mean Pain Scores at Week 5|Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.|Week 5|Full analysis set. Observed case.||score on scale||Standard Error|Least Squares Mean
730444|NCT00394901|Primary|Mean Pain Scores at Week 4|Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.|Week4|Full analysis set. Observed case.||score on scale||Standard Error|Least Squares Mean
730445|NCT00394901|Secondary|Number of Patients Not Reporting Hyperalgesia|Participants not reporting hyperalgesia.|Week13/discontinuation|Full analysis set. Last observation carried forward.||participants|||Number
730446|NCT00394901|Secondary|Number of Patients Not Reporting Allodynia|Participants not reporting allodynia.|Week13/discontinuation|Full analysis set. Last observation carried forward.||participants|||Number
730447|NCT00394901|Secondary|Endpoint Short-Form 36-Item Health Survey Scores: Mental Health|Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.|Week13/discontinuation|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
730448|NCT00394901|Secondary|Endpoint Short-Form 36-Item Health Survey Scores: Vitality|Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.|Week13/discontinuation|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
730449|NCT00394901|Secondary|Endpoint Short-Form 36-Item Health Survey Scores: Role Limitations-Emotional|Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.|Week13/discontinuation|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
730450|NCT00394901|Secondary|Endpoint Short-Form 36-Item Health Survey Scores: Social Functioning|Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.|Week13/discontinuation|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
730451|NCT00394901|Secondary|Endpoint Short-Form 36-Item Health Survey Scores: General Health Perception|Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.|Week13/discontinuation|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
730452|NCT00394901|Secondary|Endpoint Short-Form 36-Item Health Survey Scores: Bodily Pain|Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.|Week13/discontinuation|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
730453|NCT00394901|Secondary|Endpoint Short-Form 36-Item Health Survey Scores: Role Limitations-Physical|Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.|Week13/discontinuation|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
730454|NCT00394901|Secondary|Endpoint Short-Form 36-Item Health Survey Scores: Physical Functioning|Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.|Week13/discontinuation|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
730455|NCT00394901|Secondary|Endpoint Clinical Global Impression Change|Clinical Global Impression Change is scaled from 1 to 7. 1=very much improved, 7=very much worse.|Week13/discontinuation|Full analysis set. Last observation carried forward.||score on scale||Standard Deviation|Mean
730456|NCT00394901|Secondary|Endpoint Patient Global Impression Change|Patient Global Impression Change is scaled from 1 to 7. 1=very much improved, 7=very much worse.|Week13/discontinuation|Full analysis set. Last observation carried forward.||score on scale||Standard Deviation|Mean
730457|NCT00394901|Secondary|Endpoint Medical Outcomes Study Sleep Scale: Number of Participants With Optimal Sleep|Number of participants who reported Optimal Sleep|Week13/discontinuation|Full analysis set. Last observation carried forward.||participants|||Number
730458|NCT00394901|Secondary|Endpoint Medical Outcomes Study Sleep Scale Scores:Overall Sleep Problem Index|Score range for overall sleep problem index is 0-100. Higher scores indicate more of the attribute.|Week13/discontinuation|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
730459|NCT00394901|Secondary|Endpoint Medical Outcomes Study Sleep Scale Scores:Somnolence|Score range for Somnolence is 0-100. Higher scores indicate more of the attribute.|Week13/discontinuation|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
730460|NCT00394901|Secondary|Endpoint Medical Outcomes Study Sleep Scale Scores:Sleep Adequacy|Score range for sleep adequacy is 0-100. Higher scores indicate more of the attribute.|Week13/discontinuation|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
731047|NCT00401414|Secondary|Per-patient Percentage of INRs Out of the Therapeutic Range|The INR (international normalized ratio) is a derived measure of the prothrombin time. In this trial, a therapeutic INR was considered 1.8 to 3.2|90 Days|||percentage of INRs out of range||Standard Deviation|Mean
730461|NCT00394901|Secondary|Endpoint Medical Outcomes Study Sleep Scale Scores:Quantity of Sleep|Sleep Quantity subscale is scored from 0-24 indicating the number of hours of sleep. Higher scores indicate more of the attribute named in the subscale.|Week13/discontinuation|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
730462|NCT00394901|Secondary|Endpoint Medical Outcomes Study Sleep Scale Scores:Awaken Short of Breath or With Headache|Score range for awaken short of breath or with headache is 0-100. Higher scores indicate more of the attribute.|Week13/discontinuation|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
730463|NCT00394901|Secondary|Endpoint Medical Outcomes Study Sleep Scale Scores:Snoring|Score range for snoring is 0-100.Higher scores indicate more of the attribute.|Week13/discontinuation|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
730464|NCT00394901|Secondary|Endpoint Medical Outcomes Study Sleep Scale Scores:Sleep Disturbance|Score range for sleep disturbance is 0-100.Higher scores indicate more of the attribute.|Week13/discontinuation|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
730465|NCT00394901|Secondary|Mean Sleep Interference Scores at Endpoint|Scores range from 0-10. Higher scores indicate more severe interference with sleep.|Week13/discontinuation|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
730466|NCT00394901|Secondary|Endpoint Present Pain Intensity Scores of the Short-Form McGill Pain Questionnaire|Present pain intensity score range from 0-5. Higher scores indicate more severe pain.|Week13/discontinuation|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
730467|NCT00394901|Secondary|Endpoint Visual Analogue Scale Scores of the Short-Form McGill Pain Questionnaire|Visual Analogue Scale Score range from 0-100mm. Higher scores indicate more severe pain.|Week13/discontinuation|Full analysis set. Last observation carried forward.||mm||Standard Error|Least Squares Mean
730468|NCT00394901|Secondary|Endpoint Total Scores of the Short-Form McGill Pain Questionnaire|Total score range from 0-45. Higher scores indicate more severe pain.|Week13/discontinuation|Full analysis set. Last observation carried forward||score on scale||Standard Error|Least Squares Mean
730469|NCT00394901|Secondary|Endpoint Affective Scores of the Short-Form McGill Pain Questionnaire|Affective score range from 0-12. Higher scores indicate more severe pain.|Week13/discontinuation|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
730470|NCT00394901|Secondary|Endpoint Sensory Scores of the Short-Form McGill Pain Questionnaire|Sensory score range from 0-33. Higher scores indicate more severe pain.|Week13/discontinuation|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
730471|NCT00394901|Primary|Mean Pain Scores at Week 3|Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.|Week 3|Full analysis set. Observed case.||score on scale||Standard Error|Least Squares Mean
730472|NCT00394901|Primary|Mean Pain Scores at Week 2|Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.|Week 2|Full analysis set. Observed case.||score on scale||Standard Error|Least Squares Mean
730473|NCT00394901|Primary|Mean Pain Scores at Week 1|Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.|Week 1|Full analysis set. Observed case.||score on scale||Standard Error|Least Squares Mean
730474|NCT00394901|Primary|Number of Responders|A responder is defined as a subject with a 50% reduction in weekly mean pain score from baseline to endpoint.|Week13/discontinuation|Full analysis set. Last observation carried forward.||participants|||Number
730475|NCT00394901|Primary|Mean Pain Score at Endpoint by Groups of Subjects With Expected Similar Plasma Concentrations|Endpoint mean pain score is defined as the mean of the last 7 daily pain diary rating while taking the study medication, up to and including day after last dose. Scores range from 0-10 (11 points ordinal) with higher scores indicating increased pain.|Week13/discontinuation|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
730476|NCT00394901|Primary|Mean Pain Scores at Endpoint|Endpoint mean pain score is defined as the mean of the last 7 daily pain diary rating while taking the study medication, up to and including day after last dose. Scores range from 0-10 (11 points ordinal) with higher scores indicating increased pain.|Week13/discontinuation|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
730477|NCT00394914|Secondary|LS Mean Change From Baseline in Asthma-Related Sleep Interference|Participants entered their asthma-related changes in sleep into an e-diary once daily (in the morning) beginning at the Screening Visit through completion of the study. Changes from Baseline in asthma-related sleep interference were determined using the following question: How did cold and asthma symptoms interfere with your sleep? The question was scored as follows: 0 = None, no interference with sleep at all, 1 = Mild, not annoying or troublesome, adequate amount of sleep, 2 = Moderate, interfered somewhat with sleep, woke up a few times, average sleep, 3 = Severe, substantially interfered with sleep, poor sleep. The Baseline for diary symptoms was the average of the last seven assessments prior to Randomization. Pooled SDs and LS means were calculated based on an ANOVA model.|Baseline through the Final Visit (Day 21)|Efficacy analyses were based on all randomized participants (intent-to-treat principle) with at least some sleep follow-up information.||units on a scale||Standard Deviation|Least Squares Mean
730478|NCT00394914|Secondary|LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage|SABAs such as albuterol were permitted during the study as rescue medication and required a 6-hour washout prior to each visit. Participants entered their asthma medication use into an e-diary twice daily beginning at the Screening Visit through completion of the study. The Baseline for diary symptoms was the average of the last seven assessments prior to Randomization. Pooled SDs and LS means were calculated based on an ANOVA model.|Baseline through the Final Visit (Day 21)|Efficacy analyses were based on all randomized participants (intent-to-treat principle) with at least some SABA follow-up information.||number of puffs of SABA||Standard Deviation|Least Squares Mean
731048|NCT00401414|Secondary|Time to the First Therapeutic INR.|The INR (international normalized ratio) is a derived measure of the prothrombin time. In this trial, a therapeutic INR was considered 1.8 to 3.2|90 Days|||Days||Standard Deviation|Mean
730479|NCT00394914|Secondary|LS Mean Change From Baseline in Total Asthma Symptom Score|Participants entered their asthma symptoms into an e-diary twice daily beginning at the Screening Visit through completion of the study. The total asthma symptom score was the sum of 3 scores for wheeze, cough, and dyspnea. Each symptom is scored as follows: 0 = none-sign/symptom is not present, 1 = mild-sign/symptom noticeable but did not bother me or interfere with my normal daily activities/sleep, 2 = moderate- sign/symptom annoying and may have interfered with my normal daily activities/sleep, or 3 = severe-symptom very uncomfortable and interfered with most or all of my normal daily activities/sleep. The total score ranges from 0 to 9, with increasing scores reflecting more severe asthma. Baseline values were defined as the average of the last seven assessments prior to randomization (before exposure to an index case). Pooled SDs and LS means were calculated based on an ANOVA model.|Baseline through the Final Visit (Day 21)|Efficacy analyses were based on all randomized participants (intent-to-treat principle) with at least some asthma symptom score follow-up information.||units on a scale||Standard Deviation|Least Squares Mean
730480|NCT00394914|Secondary|LS Mean Change From Baseline in Total Cold Symptom Score|Participants entered their cold symptoms into an e-diary twice daily beginning at the Screening Visit through completion of the study. The total cold symptom score was the sum of 6 scores for rhinorrhea, nasal congestion, cough, score throat, malaise, and myalgia. Each symptom is scored as follows: 0 = none-sign/symptom is not present, 1 = mild-sign/symptom noticeable but did not bother me or interfere with my normal daily activities/sleep, 2 = moderate- sign/symptom annoying and may have interfered with my normal daily activities/sleep, or 3 = severe-symptom very uncomfortable and interfered with most or all of my normal daily activities/sleep. The total score ranges from 0 to 18, with increasing scores reflecting more severe colds. Baseline values were defined as the average of the last seven assessments prior to randomization (before exposure to an index case). Pooled SDs and LS means were calculated based on an ANOVA model.|Baseline through the Final Visit (Day 21)|Efficacy analyses were based on all randomized participants (intent-to-treat principle) with at least some cold symptom score follow-up information.||units on a scale||Standard Deviation|Least Squares Mean
730481|NCT00394914|Secondary|LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM|PEF is a person's maximum speed of expiration as measured with a peak flow meter and was measured twice daily in the morning (AM) and evening (PM). Pooled SDs and LS means were calculated based on an ANOVA model.|Baseline through the Final Visit (Day 21)|Efficacy analyses were based on all randomized participants (intent-to-treat principle) with at least some PEF follow-up information.||L/min||Standard Deviation|Least Squares Mean
730482|NCT00394914|Secondary|LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM|PEF is a person's maximum speed of expiration as measured with a peak flow meter and was measured twice daily in the morning (AM) and evening (PM). Pooled SDs and LS means were calculated based on an ANOVA model.|Baseline through the Final Visit (Day 21)|Efficacy analyses were based on all randomized participants (intent-to-treat principle) with at least some PEF follow-up information.||L/min||Standard Deviation|Least Squares Mean
730483|NCT00394914|Secondary|LS Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Pooled SDs and LS means were calculated based on an ANOVA model.|Baseline through the Final Visit (Day 21)|Efficacy analyses were based on all randomized participants (intent-to-treat principle) with at least some FEV1 follow-up information.||liters||Standard Deviation|Least Squares Mean
730484|NCT00394914|Secondary|LS Mean Change From Baseline in the Asthma Control Questionnaire (ACQ)|The ACQ is a validated instrument containing 7 questions to assess asthma control which incorporates symptoms, beta-agonist use, and spirometry. Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of the 7 items and therefore ranges between 0 (well controlled) and 6 (extremely poorly controlled). The ACQ completed on the day of exposure was the Baseline ACQ. Pooled standard deviations (SDs) and least square (LS) means were calculated based on an analysis of variates (ANOVA) model.|Baseline through the Final Visit (Day 21)|Efficacy analyses were based on all randomized participants (intent-to-treat principle) with at least some ACQ follow-up information.||units on a scale||Standard Deviation|Least Squares Mean
730485|NCT00394914|Primary|Percentage of Participants With Asthma Exacerbations Together With Rhinovirus-Positive PCR|"Asthma exacerbation was defined as a participant having one of the following:
0.5 point or more increase in the Asthma Control Questionnaire (ACQ) from Baseline at Day 7. The ACQ is a validated instrument containing 7 questions to assess asthma control which incorporates symptoms, beta-agonist use, and spirometry. Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of the 7 items and therefore ranges between 0 (well controlled) and 6 (extremely poorly controlled). The ACQ completed on the day of exposure was the Baseline ACQ.
Any change to asthma treatment as prescribed by a physician, unscheduled contact (either office visit or phone contact where medication was changed for asthma symptoms), emergency room visit, or hospitalization.
PCR+ was defined as positive or equivocal outcome of the picornavirus test any time after randomization."|From time of exposure to index case to end of Follow-up Period (21 days)|Efficacy analyses were based on all randomized participants (intent-to-treat principle) with at least some follow-up information. Randomized participants with no follow-up information were included in the number of participants assigned to each treatment group to determine exacerbation.||percentage of participants|||Number
730486|NCT00394914|Primary|Percentage of Participants With Rhinovirus PCR-Positive Colds|The common cold was defined as moderate or severe rhinorrhea and at least one other cold symptom of moderate to severe intensity for at least 1 day, together with rhinovirus-positive polymerase chain reaction (PCR), after a participant had temporal exposure to an index case. PCR+ was defined as positive or equivocal outcome of the picornavirus test any time after randomization.|From time of exposure to index case to end of Follow-up Period (21 days)|Efficacy analyses were based on all randomized participants (intent-to-treat principle) with at least some follow-up information. Randomized participants with no follow-up information were included in the number of participants assigned to each treatment group to determine rhinovirus cold.||percentage of participants|||Number
730487|NCT00394953|Secondary|Number of Participants With Any Adverse Events, Serious Adverse Events, and Deaths|An adverse event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. A serious adverse event (SAE) is any adverse event that can result in death or is life-threatening or required in participants hospitalization or prolongation of existing hospitalization or results in persistent or significant disability/incapacity; or is a congenital anomaly/birth defect; or is medically significant or requires intervention to prevent one or other of the outcomes listed above. SAEs were reported up to Week 56, while nonserious AEs up to Week 52.|From screening to Week 56|The Safety Population was defined as all participants who received at least one dose of MIRCERA or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not. Among the 14 deaths in Darbepoetin alfa group, 3 participants died after withdrawal from the study and within 30 days after last dose of study drug.||Participants|||Number
730488|NCT00394953|Secondary|Mean Pulse Rate Over Time|Pulse rate is defined as the number of heartbeats in a minute and was assessed in sitting position of the participants at every week from Baseline (Week -4 to Week -1) to Week 53. Summary data of mean values of pulse rate are presented at Baseline (Week -4 to Week -1), Week 28 and Week 52.|Baseline (Week -4 to Week -1), Week 28, and Week 52|The Safety population was defined as all participants who received at least one dose of MIRCERA or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not. The 'n' represents the number of participants at a specified time point.||beats per minute||Standard Deviation|Mean
730489|NCT00394953|Secondary|Median Blood Pressure Over Time|Systolic and diastolic blood pressures (BP) were measured before and after the dialysis session at every week from Baseline (Week -4 to Week -1) to Week 53. Median pre-dialysis diastolic blood pressure (PrD DBP) , median post-dialysis diastolic blood pressure (PoD DBP), median pre-dialysis systolic blood pressure (PrD SBP), and post-dialysis systolic blood pressure (PoD SBP) were reported at Baseline (Week -4 to Week -1) , Week 28 and Week 52.|Baseline (Week -4 to Week -1), Week 28, and Week 52|Safety Population included all participants who received at least one dose of MIRCERA or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not. The 'n' represents the number of participants at a specified time point.||millimeter of mercury||Full Range|Median
730490|NCT00394953|Secondary|Number of Participants With Marked Laboratory Abnormality Over Time|Values of laboratory parameters higher (H) or lower (L) than the Roche defined reference range were considered as abnormality. The laboratory parameters with abnormality were platelets, white blood cells (WBC), albumin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), and potassium. Blood samples were drawn before drug administration and before the dialysis session.|Up to Week 53|The Safety Population was defined as all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not. The 'n' represents the number of participants at a specified time point.||participants|||Number
730491|NCT00394953|Secondary|Mean Percentage Change in MIRCERA and Darbepoetin Alpha Dose Over Time|All participants received once monthly treatment schedule of both MIRCERA and darbepoetin alpha for the respective treatment arms after Week 27 and these analyses are based on the absolute doses. The average dose in Months 11 and 12 was defined as the mean of all administered doses between study Days 302 and 363. The change in dose was calculated as the percentage change between the respective dose at Week 27 and the average corresponding dose during Months 11 and 12 in each treatment group.|Week 27 to Month 12|ITT population included all randomized participants. Data is presented for the participants available at the time of assessment.||percent change||Standard Deviation|Mean
730492|NCT00394953|Primary|Percentage of Participants With Lesser Than or Equal to One Gram Per Deciliter Decrease in Average Hemoglobin From Baseline and Maintaining Average Hemoglobin Level Greater Than or Equal to 10.5 g/dL Over Evaluation Period|Randomized participants with an average hemoglobin (Hb) decrease from Baseline (Week -4 to Week -1) not exceeding 1.0 gram per deciliter (g/dL) and an absolute average Hb >= 10.5 g/dL during the evaluation period (Weeks 50-53) were defined as responders. Non-responders included participants without any Hb data during the second treatment period and those who did not meet the response criteria and thus were not included in the analysis.|Baseline (Week -4 to Week -1) and Evaluation period (Weeks 50 to 53)|ITT population included all randomized participants.||Percentage of participants||95% Confidence Interval|Number
730493|NCT00395018|Primary|Number of Participants With HBV DNA by PCR >= 50 IU/mL Through Week 72|HBV DNA assessments were performed using the Roche COBAS® TaqMan High+Pure system (HPS) assay. HBV DNA => 50 IU/mL = approximately => 300 copies/mL.|At baseline (day 1), week 12, 24, 36, 48, 60, and 72|Evaluable population: Treated participants who received at least 1 month of ETV therapy. Non-Completer = Missing (NC = M) approach was used where participants who discontinued early or were missing the measurement were excluded from the specific analysis.||participants||95% Confidence Interval|Number
730494|NCT00395018|Secondary|Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) Follow-up: Serum Chemistry (All Grades)|Normal ranges are local lab data and vary according to the site. Criteria for laboratory abnormalities:ALT:>1.25xULN;AST:>1.25xULN;ALP:>1.25xULN;Total Bilirubin:>1.1xULN;Serum Lipase:>1.10xULN;Creatinine:>1.1xULN;Blood Urea Nitrogen:>1.25xULN;Hyperglycemia:>116mg/dL;Hypoglycemia:<64mg/dL;Hyponatremia:<132meq/L;Hypernatremia:>148meq/L;Hypokalemia:<3.4meq/L;hyperkalemia:>5.6meq/L;Hypochloremia:<93meq/L;Hyperchloremia:>113meq/L;Albumin: Decrease >= 1g/dL from baseline and < 3 g/dL. HYPER=value>ULN(upper limit of normal). HYPO=value<LLN (lower limit of normal).|OT:From start of dosing through Week 72 + 5 days; OF:End of OT through 24-weeks follow-up|Treated population: Participants who received atleast 1 dose of study drug.||participants|||Number
730495|NCT00395018|Secondary|Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment Follow-up(OF): Hematology (All Grades)|Criteria for hematology abnormalities were: Hemoglobin : <11.0 g/dL; White Blood Cells : <4000/mm^3; Neutrophils : <1500/mm^3; Platelets : < 99,000/mm^3; International Normalized Ratio (INR) : increase >= 0.5 from baseline.|OT:From start of dosing through Week 72 + 5 days; OF:End of OT through 24-weeks follow-up|Treated population: All subjects who received atleast 1 dose of study drug.||participants|||Number
730953|NCT00398632|Secondary|Inventory of Depressive Symptomology||baseline and last visit||||||
731248|NCT00402688|Primary|Clinical Success|Defined as cured or improved. Response is based on the resolution of signs and symptoms at post-therapy.|Posttherapy Visit (Study Day 33-36)|Modified Intent to Treat (mITT)||Participants|||Number
730496|NCT00395018|Secondary|Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations From Study Drug Due to AEs (On-treatment [OT] and Off-treatment Follow-up [OF])|AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or an overdose. Toxicity grading by modified WHO grade system. Grade (GR) 2=moderate; GR3=severe; GR4=very severe. OT=from start of dosing to end of dosing+5 days; OF=from end of dosing+6 days to start of other anti-HBV therapy or end of follow-up.|OT:From start of dosing through Week 72 + 5 days; OF:End of OT through 24-weeks follow-up|Treated population: Participants who received atleast 1 dose of study drug.||participants|||Number
730497|NCT00395018|Secondary|Number of Participants With Re-transplantation Through Week 72||Through week 72|Treated population: Participants who received atleast 1 dose of study drug.||participants|||Number
730498|NCT00395018|Secondary|Number of Participants With Liver Rejection Through Week 72||Through week 72|Treated participants: Participants who received atleast 1 dose of study drug.||participants|||Number
730499|NCT00395018|Secondary|Prothrombin Time (PT) at Week 72|Prothrombin, a liver protein, plays an important role in the extrinsic pathway of clotting. Increased prothrombin time indicates abnormal liver functioning. Normal prothrombin time varies from laboratory to laboratory. Generally, normal prothrombin time varies between 10 to 13.2 seconds. Abnormal PT: > 1.01 x ULN.|At week 72|Treated participants with measures available at week 72.||seconds||Standard Error|Mean
730500|NCT00395018|Secondary|Total Bilirubin at Week 72|Bilirubin measures are used to diagnose or monitor liver functioning or diseases that include hepatitis. Viral hepatitis is one of the condition in which bilirubin levels are elevated. Normal range varies from laboratory to laboratory. Bilirubin abnormality : => 1.1 x ULN mg/dL.|At week 72|Treated participants with measures available at week 72.||mg/dL||Standard Error|Mean
730501|NCT00395018|Secondary|Percentage of Participants With HBsAg Recurrence At Week 72|HBsAg = a part of the hepatitis B virus that, when in the blood, is an early marker of infection. HBsAg recurrence is defined as having detectable HBsAg among participants who have already experienced loss of HBsAg on-treatment. HBsAg recurrence = HBsAg-positive at the specified analysis week.|At week 72|Evaluable participants: Treated participants who received at least 1 month of ETV therapy. LOCF approach was used for participants with no measurement in the specified visit window.||percentage of participants||95% Confidence Interval|Number
730502|NCT00395018|Secondary|Percentage of Participants With HBsAg Seroconversion at Week 72|HBsAg = a part of the hepatitis B virus that, when in the blood, is an early marker of infection. HBs seroconversion is defined as HBsAg loss with positive HBsAb.|At week 72|Evaluable participants: Treated participants who received at least 1 month of ETV therapy. LOCF approach was used for participants with no measurement in the specified visit window.||percentage of participants||95% Confidence Interval|Number
730503|NCT00395018|Secondary|Percentage of Participants With HBsAg Loss at Week 72|HBsAg = a part of the hepatitis B virus that, when in the blood, is an early marker of infection. HBsAg loss = HBsAg-negative at the specified analysis week.|At week 72|Evaluable participants: Treated participants who received at least 1 month of ETV therapy. LOCF approach was used for participants with no measurement in the specified visit window.||percentage of participants||95% Confidence Interval|Number
730504|NCT00395018|Secondary|Percentage of Participants With HBeAg Seroconversion at Week 72 (for HBeAg-positive Participants)|HBeAg is a hepatitis B viral protein. HBeAg Seroconversion = HBeAg Loss and Presence of Hepatitis B e Antibody (HBeAb).|At week 72|HBeAg-positive participants at baseline who received at least 1 month of ETV therapy. LOCF approach was used for participants with no measurement in the specified visit window.||percentage of participants||95% Confidence Interval|Number
730505|NCT00395018|Secondary|Percentage of Participants With HBeAg Loss at Week 72 (for HBeAg-positive Participants)|HBeAg is a hepatitis B viral protein. HBeAg loss = HBeAg-negative at the specified analysis week.|At week 72|HBeAg positive participants at baseline who received at least 1 month of ETV therapy. LOCF approach was used for participants with no measurement in the specified visit window.||percentage of participants||95% Confidence Interval|Number
730506|NCT00395018|Secondary|Percentage of Participants With HBV DNA < 50 IU/mL (Approximately 300 Copies/mL) by PCR at the End of Post-dosing Follow-up|HBV DNA assessments were to be performed using the Roche COBAS® TaqMan AmpliPrep assay. HBV DNA < 50 IU/mL = approximately 300 copies/mL.|At 72 weeks + 24 weeks follow-up|This analysis was planned if > 10% of treated participants had HBV DNA measurements during the off-treatment follow-up period.||percentage of participants|||Number
730507|NCT00395018|Secondary|Distribution of ALT Levels Through 72 Weeks: Overall|ALT is an enzyme present in serum and various tissues of the body, associated commonly with the liver. Elevated levels of ALT often suggests existence of medical problems which includes viral hepatitis. Normal range varies from laboratory to laboratory. Values of 5-60 U/L is usually considered normal. ALT abnormality = >1.25 x ULN (upper limit of normal).|On Day 1 (baseline) and at week 4, 12, 24, 36, 48, 60, 72|Evaluable population: Treated participants who received at least 1 month of ETV therapy.||U/L||Standard Error|Mean
730508|NCT00395018|Primary|Percentage of Participants With HBV Deoxyribonucleic Acid (DNA) => 50 IU/mL by Polymerase Chain Reaction (PCR) at Week 72|HBV DNA assessments were performed using the Roche COBAS® TaqMan High+Pure system (HPS) assay. HBV DNA => 50 IU/mL = approximately => 300 copies/mL.|At 72 weeks|Evaluable population: Treated participants who received at least 1 month of ETV therapy. Last observation carried forward (LOCF) approach was used for participants with no measurement in the specified visit window.||percentage of participants||95% Confidence Interval|Number
730509|NCT00395044|Secondary|Change From Baseline in Cognitive Functioning Using the Delis-Kaplan Executive Function System (D-KEFS) at Week 4|The D-KEFS is a testing battery designed to measure executive functioning, a critical component of participating in cognitive behavioral therapy used to treat marijuana dependence. Data were obtained from the D-KEFS test instruments completed at baseline and week 4, which included the Trail Making Test, Verbal Fluency Test, and Color-Word Interference Test. Scaled scores range from 1 (worst) to 19 (best). Change = (Week 4 score - Week 0 score). Positive values indicate increased executive functioning.|Week 0 and Week 4|Cognitive testing was done in a subset of participants enrolled in the study, beginning with randomized subject #21 and continuing until the 50th subject was randomized. The number analyzed is the total number available for analysis that completed both the Baseline and Week 4 assessment.||scores on a scale||Standard Deviation|Mean
730510|NCT00395044|Secondary|Change From Week 0 in Cannabis-related Problems on the Marijuana Problem Scale (MPS) at Week 12|The MPS is an instrument to assess the incidence of physical, psychological, social, and functioning problems that can result from cannabis dependence. The Total score ranges from 0-38 where 0=best outcome and 38=worst outcome. Change = (Week 12 score - Week 0 score).|Week 0 and Week 12|||units on a scale||Standard Deviation|Mean
730511|NCT00395044|Secondary|Change From Week 0 in Craving on the Marijuana Withdrawal Checklist Marijuana Craving Question at Week 12|The Marijuana Craving question of the Marijuana Withdrawal Checklist assesses severity of craving to smoke marijuana. The craving question is rated on a scale of 0-3 where 0=best outcome (no symptoms) and 3=worst outcome (severe symptoms). Change = (Week 12 score - Week 0 score).|Week 0 and Week 12|||units on a scale||Standard Deviation|Mean
730512|NCT00395044|Secondary|Change From Week 0 in Mood on the Beck Depression Inventory (BDI-II) at Week 12|The BDI-II is a self-rating of severity of depressive symptoms. The Total score range on the BDI-II is from 0-63; 0=best outcome; 63=worst outcome. Change = (Week 12 score - Week 0 score).|Week 0 and Week 12|||units on a scale||Standard Deviation|Mean
730513|NCT00395044|Secondary|Change in Sleep Quality on the Pittsburgh Sleep Quality Index (PSQI) at Week 12|The PSQI is an instrument to assess subjective sleep quality and disturbance. The range on the measure is from 0-21: 0=best outcome; 21=worst outcome. Change = (Week 12 score - Week 0 score).|Week 0 and Week 12|||units on a scale||Standard Deviation|Mean
730514|NCT00395044|Secondary|Change From Week 0 in Withdrawal Symptom Severity on the Marijuana Withdrawal Checklist (MWC) at Week 12|The MWC is an instrument to assess the severity of frequently reported cannabis withdrawal symptoms. Each question on the measure is recorded as a severity rating between 0-3: 0=best outcome; 3=worst outcome. The severity rating of each question was averaged to obtain a single marijuana withdrawal severity score. Change = (Week 12 score - Week 0 score).|Week 0 and Week 12|||units on a scale||Standard Deviation|Mean
730515|NCT00395044|Primary|Change From Week 0 in Cannabis Use Using Urinary CN-THCCOOH Levels at Week 12|Urinary THC/Cr ratio, also known as CN-THCCOOH (creatinine normalized tetrahydrocannabinol carboxylic acid), is a highly sensitive and specific quantitative analytic procedure to determine current marijuana metabolite levels in the urine as well as new marijuana use or abstinence. Gas chromatography-mass spectrometric levels of 11-nor-9-carboxy-9-THC (THC-COOH), the primary marijuana metabolite, are normalized to the urine creatinine (CN) concentration to reduce the variability of drug measurement attributable to urine dilution. Negative values indicate decreased use.|Week 0 and Week 12|||ng/ml||Standard Deviation|Mean
730516|NCT00395057|Secondary|Time to Treatment With Standard of Care at Month 6|Time to treatment with standard-of-care at month 6, defined as the number of days before the use of rescue therapy occurred.|Month 6|Intent-To-Treat (ITT). The ITT population included all patients who started the study (randomized).||Number of Days||95% Confidence Interval|Median
730517|NCT00395057|Secondary|Visual Functioning Questionnaire (VFQ) at Month 3|Visual Functioning Questionnaire (VFQ) at Month 3. The VFQ includes 25 questions which assess visual impairment on functioning and specific aspects of health-related quality of life. Study terminated; data for this outcome measure were not analyzed.|Month 3|Intent-To-Treat (ITT). The ITT population included all patients who started the study (randomized). Data for this outcome measure were not analyzed as the study was terminated early.|||||
730518|NCT00395057|Secondary|Foveal Thickness as Assessed by Optical Coherence Tomography (OCT) at Month 3|Foveal thickness as assessed by OCT at month 3. The fovea is a part of the eye, located in the center of the macula region of the retina. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. The fovea is responsible for sharp central vision, which is necessary for reading or any activity where visual detail is of primary importance. Normal foveal thickness ranges from 175 to 250 microns. A foveal thickness greater than 250 microns represents worsening vision.|Month 3|Intent-To-Treat (ITT). The ITT population included all patients who started the study (randomized).||Microns||Standard Deviation|Mean
730519|NCT00395057|Secondary|Lesion Size as Assessed by Fluorescein Angiography (FA) and Photography at Month 3|Lesion size as assessed by FA and photography at month 3. FA is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. Photographs are taken with a specialized low-power microscope with an attached camera designed to photograph the interior of the eye, including the retina and optic disc.|Month 3|Intent-To-Treat. The ITT population included all patients who started the study (randomized).||Millimeters squared (mm^2)||Standard Deviation|Mean
730520|NCT00395057|Primary|Percentage of Patients With Improvement in Best Corrected Visual Acuity (BCVA) of 15 or More Letters at Month 3|Percentage of patients with improvement in BCVA of 15 or more letters at Month 3. BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|Month 3|Intent-To-Treat (ITT). The ITT population included all patients who started the study (randomized).||Percentage of Patients|||Number
730521|NCT00395083|Secondary|Time to All-Cause Death||From randomization until death, assessed up to 26 months|||years||95% Confidence Interval|Median
730522|NCT00395083|Secondary|Hazard Ratio for All-Cause Mortality||26 months|||participants|||Number
730523|NCT00395083|Primary|Hazard Ratio for First COPD Hospitalization||26 months|||participants|||Number
730524|NCT00395083|Primary|Hospitalization-free Survival - Time to Event||From randomization until date of first hospitalization for COPD, assessed up to 26 months|||years||95% Confidence Interval|Median
731249|NCT00402714|Secondary|Overall Survival||2 years following stem cell transplant|||participants|||Number
730529|NCT00395161|Secondary|All-cause 28-day Mortality Rate.||28 days after admission to the PICU|This safety outcome was analyzed by treatment received, among a total of 284 children who received treatment and had known 28-day status.||participants|||Number
730530|NCT00395161|Secondary|Incidence of Prolonged Lymphopenia (Absolute Lymphocyte Count Less Than or Equal to 1,000/mm³ for > or Equal to 7 Days)|What is reported is the number of participants with counts qualifying as lymphopenia.|from time of PICU admission till discharge from PICU|All randomized patients (intention to treat analysis)||participants|||Number
730531|NCT00395161|Secondary|Antibiotic-free Days||48 hours after admission until PICU discharge|All randomized patients per intention to treat analysis||Days||Inter-Quartile Range|Median
730532|NCT00395161|Secondary|Rate of Nosocomial Infection or Clinical Sepsis Per 100 Study Days||48 hours after PICU admission till discharge from PICU|All randomized patients analyzed by intention to treat||Mean number of events per 100 study days||95% Confidence Interval|Mean
730533|NCT00395161|Primary|The Primary Endpoint of This Study is the Median Time Between Admission to the PICU and Occurrence of Nosocomial Infection or Clinical Sepsis in PICU Patients Who Have Endotracheal Tubes, Central Venous Catheters, or Urinary Catheters.||48 hours after admission until 5 days after discharged from the PICU|Intention to treat analysis of all randomized patients.||Days||95% Confidence Interval|Median
730534|NCT00396084|Secondary|Percent Dosing Interval Above Minimum Inhibitory Concentration (MIC)|Determined by linear extrapolation of concentration-versus-time curve to intersection with MIC.|Day 5 (7 time points)|Twenty-nine patients underwent pharmacodynamic (PD) sampling after receiving 5 daily doses of study drug. One subject in the linezolid twice daily arm withdrew from the study after randomization before receiving any doses of study drug.||Percentage||Inter-Quartile Range|Mean
730535|NCT00396084|Secondary|Area Under the Curve (AUC) Adjusted for Free Drug Concentrations/Minimum Inhibitory Concentration (MIC)|Area Under the Curve 0-12 (AUC 0-12) Adjusted for Free Drug Concentrations/Minimum Inhibitory Concentration (MIC) and AUC 0-24/MIC|Day 5 (7 time points)|Twenty-nine patients underwent pharmacodynamic (PD) sampling after receiving 5 daily doses of study drug. One subject in the linezolid twice daily arm withdrew from the study after randomization before receiving any doses of study drug.||ug/h/ml||Inter-Quartile Range|Median
730536|NCT00396084|Secondary|Area Under the Curve (AUC) During First 12 and 24 Hours Adjusted for Free Drug Concentrations|Median pharmacodynamic parameters (range) adjusted for free drug concentrations. AUC 0-12 and AUC 0-24 = area under the curve during the first 12 and 24 hours after dosing, respectively|Day 5 (7 time points)|Twenty-nine patients underwent pharmacodynamic (PD) sampling after receiving 5 daily doses of study drug. One subject in the linezolid twice daily arm withdrew from the study after randomization before receiving any doses of study drug.||ug/h/ml||Inter-Quartile Range|Median
730537|NCT00396084|Secondary|Maximum Plasma Drug Concentration/Minimum Inhibitory Concentration (Cmax/MIC) Adjusted for Free Drug Concentrations||Day 5 (7 time points)|Twenty-nine patients underwent pharmacodynamic sampling after receiving 5 daily doses of study drug. One subject in the linezolid twice daily arm withdrew from the study after randomization before receiving any doses of study drug.||ug/ml||Inter-Quartile Range|Median
730538|NCT00396084|Secondary|Maximum Plasma Drug Concentrations (Cmax), Adjusted for Free Drug Concentration|Cmax adjusted for free drug concentrations after 5 days of monotherapy with study drugs|Day 5 (7 time points)|Twenty-nine patients underwent pharmacokinetic (PK) sampling after receiving 5 daily doses of study drug. One subject in the linezolid twice daily arm withdrew from the study after randomization before receiving any doses of study drug.||ug/ml||Full Range|Median
730539|NCT00396084|Secondary|Pharmacokinetic Parameters: Area Under the Curve During First 12 and 24 Hours|Median pharmacokinetic parameters (range). AUC 0-12 and AUC 0-24 = area under the curve during the first 12 and 24 hours after dosing, respectively|Day 5 (7 time points)|Twenty-nine patients underwent pharmacokinetic (PK) sampling after receiving 5 daily doses of study drug. One subject in the linezolid twice daily arm withdrew from the study after randomization before receiving any doses of study drug.||ug/h/ml||Full Range|Median
730540|NCT00396084|Secondary|Time to Maximum Plasma Drug Concentration (Tmax) and Half-life||Day 5 (7 time points)|Twenty-nine patients underwent pharmacokinetic (PK) sampling after receiving 5 daily doses of study drug. One subject in the linezolid twice daily arm withdrew from the study after randomization before receiving any doses of study drug.||hours||Full Range|Median
730541|NCT00396084|Secondary|Maximum Plasma Drug Concentration (Cmax)|Maximum Plasma Drug Concentration (Cmax), given sampling scheme|Day 5 (7 time points)|Twenty-nine patients underwent pharmacokinetic (PK) sampling after receiving 5 daily doses of study drug. One subject in the linezolid twice daily arm withdrew from the study after randomization before receiving any doses of study drug.||ug/ml||Full Range|Median
730542|NCT00396084|Secondary|Area Under the Curve During First 12 or 24 Hours / Minimum Inhibitory Concentration (AUC/MIC)|Area Under the Curve (AUC) During First 12 or 24 Hours /Minimum Inhibitory Concentration. AUC reflects total drug (bound and unbound). MIC values were determined using protein-containing media.|Day 5 (7 time points)|Thirty-nine patients underwent pharmacokinetic (PK) sampling after receiving 5 daily doses of study drug. One subject in the moxifloxacin arm was discontinued from the study before day 5 and did not undergo PK sampling||ug/ml||Inter-Quartile Range|Median
730543|NCT00396084|Secondary|Pharmacokinetic Parameters: Area Under the Curve (AUC) During First 12 and 24 Hours|Area under the curve (AUC), from time 0-12 hours for INH or 0-24 hours for gatifloxacin, levofloxacin, and moxifloxacin.|Day 5 (7 time points)|Thirty-nine patients underwent pharmacokinetic (PK) sampling after receiving 5 daily doses of study drug. Plasma samples were collected at 7 time points on the 5th day after beginning study drug monotherapy. One subject in the moxifloxacin arm was discontinued from the study before day 5 and did not undergo PK sampling.||ug/h/ml||Full Range|Median
730576|NCT00396201|Secondary|Participant Counts Grouped by Number of Apheresis Days Required to Collect ≥ 5*10^6 CD34+ Cells/kg|Counts of participants grouped by the number of apheresis days needed to collect a target for transplantation of ≥5*10^6 CD34+ cells/kg as determined by local laboratory data.|Day 5 up to day 9|Intent to treat population which included all participants who received plerixafor and achieved a target of ≥5*10^6 CD34+cells/kg||participants|||Number
730544|NCT00396084|Primary|Difference in Sputum Bacillary Loads: Extended Early Bactericidal Activity (EBA) From Days 2 to 7; Linezolid Once Daily/Linezolid Twice Daily/INH Comparison|The rate of fall in sputum cfu between day 2 and day 7 of monotherapy was estimated by the slope of the linear regression obtained by fitting the 6 sputum cfu values corresponding to Days 2 through 7.|Day 2 to Day 7 Monotherapy|One patient in the INH arm discontinued the study drug after 5 days. Days 3 and 7 cultures for another patient in the INH arm were contaminated and cfu data are not available for this patient. One patient in the linezolid twice daily arm withdrew from the study after randomization before receiving any doses of study drug.||log10 cfu/ml||Standard Deviation|Mean
730545|NCT00396084|Secondary|Maximum Plasma Drug Concentration/Minimum Inhibitory Concentration (Cmax/MIC)||Day 5 (7 time points)|Thirty-nine patients underwent pharmacokinetic (PK) sampling after receiving 5 daily doses of study drug. One subject in the moxifloxacin arm was discontinued from the study before day 5 and did not undergo PK sampling.||ug/ml||Inter-Quartile Range|Median
730546|NCT00396084|Secondary|Time to Maximum Plasma Drug Concentration (Tmax) and Half-life||Day 5 (7 time points)|Thirty-nine patients underwent pharmacokinetic (PK) sampling after receiving 5 daily doses of study drug. One subject in the moxifloxacin arm was discontinued from the study before day 5 and did not undergo PK sampling.||hours||Full Range|Median
730547|NCT00396084|Primary|Difference in Sputum Bacillary Loads: Early Bactericidal Activity (EBA) Days 0 to 2; Linezolid Once Daily/Linezolid Twice Daily/Isoniazid (INH) Comparison|Early bactericidal activity (EBA 0-2) was calculated as the rate of fall in sputum cfu (expressed in log10 units) during the first 2 days of monotherapy. Mean values for the 3 treatment groups were compared.|Day 0 to Day 2 Monotherapy|EBA 0-2 comparisons across groups were done for 29 patients. One patient in the linezolid twice daily arm withdrew from the study after randomization before receiving any doses of study drug.||log10 cfu/ml/day||Standard Deviation|Mean
730548|NCT00396084|Primary|Sputum Bacillary Loads: Adjusted Area Under the Curve (aAUC)|The adjusted area under the curve (aAUC) for sputum colony forming unit (cfu) for each day on treatment was calculated for patients in the INH arm and those in the Linezolid once daily and Linezolid twice daily arms. The aAUC represents the percentage of the expected AUC given no change in log cfu in response to study drug administration.|Study drug administration duration - 7 days monotherapy|The aAUC was calculated for 29 patients. One patient in the linezolid twice daily arm withdrew after randomization before receiving any doses of study drug.||Percentage||Standard Deviation|Mean
730549|NCT00396084|Primary|Extended Early Bactericidal Activity (EBA) From Days 2 to 7; Fluoroquinolones/Isoniazid (INH) Comparison|The rate of fall in sputum cfu between day 2 and day 7 of monotherapy was estimated by the slope of the linear regression obtained by fitting the 6 sputum cfu values corresponding to Days 2 through 7.|Day 2 to Day 7 Monotherapy|A total of 38 patients were analyzed for Early Bactericidal Activity (EBA) Days 2-7. One patient in the moxifloxacin arm discontinued the study drug after 4 days. One patient in the INH arm discontinued the study drug after 6 days.||log10 cfu/ml/day||Standard Deviation|Mean
730550|NCT00396084|Primary|Difference in Sputum Bacillary Loads: Early Bactericidal Activity (EBA) Days 0 to 2; Fluoroquinolones/Isoniazid (INH) Comparison|Early bactericidal activity (EBA 0-2) was calculated as the rate of fall in sputum colony forming units (cfu) (expressed in log10 units) during the first 2 days of monotherapy.|Day 0 to Day 2 Monotherapy|Early bactericidal activity (EBA 0-2) was calculated for 10 subjects per treatment arm (n=40).||log10 cfu/ml/day||Standard Deviation|Mean
730551|NCT00396084|Secondary|Maximum Plasma Drug Concentration (Cmax)|Maximum plasma concentration, given sampling scheme|Day 5 (7 time points)|Thirty-nine patients underwent pharmacokinetic (PK) sampling after receiving 5 daily doses of study drug. Plasma samples were collected at 7 time points on the 5th day after beginning study drug monotherapy. One subject in the moxifloxacin arm was discontinued from the study before day 5 and did not undergo PK sampling.||ug/ml||Full Range|Median
730552|NCT00396084|Secondary|Sputum Cytokine Proteins - Results Are Pending.||Study drug administration duration||||||
730553|NCT00396084|Secondary|Sputum mRNA Clearance Rate - Results Are Pending.||Study drug administration duration||||||
730554|NCT00396084|Primary|Sputum Bacillary Loads: Adjusted Area Under the Curve (aAUC)|The adjusted area under the curve (aAUC) for sputum colony forming units (cfu) for each day on treatment was calculated. The aAUC represents the percentage of the expected AUC given no change in log cfu in response to study drug administration.|Study drug administration duration - 7 days monotherapy|The aAUC was calculated for 10 subjects per treatment arm (n=40).||Percentage||Standard Deviation|Mean
730555|NCT00396097|Secondary|Change From Baseline in Height SDS at 48 Months.|Change in height SDS was measured at 48 months.|4 years|FAS included all randomized subjects who received at least 1 dose of study treatment and had at least 1 post-baseline height SDS value available. LOCF rule was applied to impute Month 24 missing height SDS data.||Standard Deviation Score (SDS)||Standard Deviation|Mean
730556|NCT00396097|Secondary|Estimated Cost of Height Gain Estimated Until Full Adult Height (FAH) at 48 Months|The estimated cost of long-term height gain until FAH was calculated.|4 years|Full analysis set (FAS) included all randomized subjects who received at least 1 dose of study treatment and had at least 1 post-baseline height SDS value available. LOCF rule was applied to impute Month 24 missing height SDS data.||mg/cm||Standard Deviation|Mean
730557|NCT00396097|Secondary|Computed Cost of Height Gain at 48 Months|The computed cost of height gain was defined as the amount of drug used relative to the observed height-gain, in terms of mg/cm, this was calculated at Month 48.|4 years|FAS included all randomized subjects who received at least 1 dose of study treatment and had at least 1 post-baseline height SDS value available. LOCF rule was applied to impute Month 24 missing height SDS data.||mg/cm||Standard Deviation|Mean
730558|NCT00396097|Secondary|Time Cost (Months Until >= -2 SDS)|Time cost was defined as the number of months needed until height SDS was within the normal limit (ie, >= -2SDS).|2 years|Full analysis set (FAS) included all randomized subjects who received at least 1 dose of study treatment and had at least 1 post-baseline height SDS value available.||Months||95% Confidence Interval|Median
730559|NCT00396097|Secondary|Variability of Height SDS at 24 Months|The continuous endpoint of variability of height SDS at 24 months was defined as the SD of the 24 month height SDS.|2 years|FAS included all randomized subjects who received at least 1 dose of study treatment and had at least 1 post-baseline height SDS value available. LOCF rule was applied to impute Month 24 missing height SDS data.||Standard Deviation Score (SDS)||Standard Deviation|Mean
730560|NCT00396097|Primary|Absolute On-target Difference (AOTD) at 24 Months|This was defined as an absolute difference between the 24-month height standard deviation score (SDS) and targeted 24-month height SDS (10th percentile (%), or –1.3 SDS). SDS indicates how similar the participant was to the reference population. These were calculated using 2000 Center for the Disease Control (CDC) growth reference tables (by age and gender).|2 years|The Full Analysis Set (FAS) included all randomized subjects who received at least 1 dose of study treatment and had at least 1 post-baseline height SDS value available. Last observation carried forward (LOCF) rule was applied to impute Month 24 missing height SDS data.||Standard Deviation Score (SDS)||Standard Deviation|Mean
730561|NCT00396136|Primary|Safety of the COROX OTW Steroid LV Pacing Lead|Number of participants with LV lead related adverse events requiring additional invasive intervention to resolve.|3 years post implant|All study participants.||participants|||Number
730562|NCT00396136|Primary|Long-term Effectiveness of the COROX Over-the-wire (OTW) Steroid in Providing Biventricular Pacing|Evaluate threshold voltage of the COROX OTW Unipolar Lead.|All follow-ups for 3 years post implant|All study participants.||Threshold Voltage|Participants|Standard Deviation|Mean
730563|NCT00396162|Secondary|Mean Number of Days of Steroid Spray Use for Each Group||8 weeks|||days||Standard Deviation|Mean
730564|NCT00396162|Secondary|Mean Number of Days of Antibiotic Use During the Study Period (0-8 Weeks)|Mean number of days that antibiotics were used in the subgroup (placebo vs Probiotic arm)|At 8 weeks after baseline measures|||days||Standard Deviation|Mean
730565|NCT00396162|Secondary|Side Effect Summary|Totals of all side effects for placebo group and treatment group over the course of the eight week trial (including patients who dropped from the study after baseline measurement). Individual categories of side-effects are listed in Adverse events section.|8 weeks|The sample size on the placebo side is reduced due to some study participants not reporting their 8 week survey||participants|||Number
730566|NCT00396162|Primary|Mean Reduction in SNOT-20 Scores|Mean reduction (and Standard deviation) in SNOT-20 scores, from baseline to 8 week measurements. SinoNasal Outcome Test measures symptom severity. It is a summary score, ranging from 0 to 100 with 100 indicating worse symptoms. Since 100 represents more severe symptoms, the changes represented here are reductions in SNOT-scores, even though they are not expressed as negative numbers.|8 weeks|||units on a scale||Standard Deviation|Mean
730567|NCT00396201|Secondary|Apparent Volume of Distribution (Vz/F) Following a Single-dose of Plerixafor|The volume of distribution (Vz/F) was calculated as apparent clearance divided by the terminal elimination rate constant.|Day 4|The last nine study participants had pharmacokinetic blood samples taken, as reflected in a protocol amendment. Results include participants from the last nine participants who had the relevant test data.||mL||Standard Deviation|Mean
730568|NCT00396201|Secondary|Apparent Clearance (CL/F) of Single-dose Plerixafor|Apparent clearance was calculated the mean dose of plerixafor divided by the area under the plasma concentration-time curve from 0 hours to infinity (AUC0-inf).|Day 4-5|The last nine study participants had pharmacokinetic blood samples taken, as reflected in a protocol amendment. Results include participants from the last nine participants who had the relevant test data.||mL/hr||Standard Deviation|Mean
730569|NCT00396201|Secondary|Area Under the Plasma Concentration-time Curve From 0 to 10 Hours (AUC0-10) Following a Single Dose of Plerixafor|Area under the plasma concentration-time curve from 0 to 10 hours (AUC0-10) following the first single dose of 240 ug/kg plerixafor.|Days 4-5|The last nine study participants had pharmacokinetic blood samples taken, as reflected in a protocol amendment. Results include participants from the last nine participants who had the relevant test data.||ng*hr/mL||Standard Deviation|Mean
730570|NCT00396201|Secondary|Half-life (T1/2) Following a Single Dose of Plerixafor|Plasma elimination half-life (T1/2) following a single dose of 240 ug/kg plerixafor.|Day 4|The last nine study participants had pharmacokinetic blood samples taken, as reflected in a protocol amendment. Results include participants from the last nine participants who had the relevant test data.||hours||Standard Deviation|Mean
730571|NCT00396201|Secondary|Time to Maximum Plasma Concentration (Tmax) Following a Single Dose of Plerixafor|Time to maximum plasma concentration (Tmax) of plerixafor following the first single dose of 240 ug/kg plerixafor was determined from direct observation of the data.|Day 4|The last nine study participants had pharmacokinetic blood samples taken, as reflected in a protocol amendment. Results include participants from the last nine participants who had the relevant test data.||hours||Standard Deviation|Mean
730572|NCT00396201|Secondary|Maximum Plasma Concentration (Cmax) Following a Single Dose of Plerixafor|Maximum plasma concentration (Cmax) of plerixafor following the first single dose of 240 ug/kg plerixafor administered.|Day 4|The last nine study participants had pharmacokinetic blood samples taken, as reflected in a protocol amendment. Results include participants from the last nine participants who had the relevant test data.||ng/mL||Standard Deviation|Mean
730573|NCT00396201|Secondary|Number of Participants With a Durable Graft at 12 Months|Graft durability was assessed by the Investigator based on complete blood count (CBC) and differential analyses at 12 months post transplantation. A graft was considered durable if blood counts were normal (acceptable) and still met the criteria for PLT and PMN engraftment.|13 months|Intent to treat population which included all participants who received plerixafor and had a transplant.||participants|||Number
730574|NCT00396201|Secondary|Number of Days Post Transplantation to Platelet (PLT) Engraftment|Median number of days to PLT engraftment following transplantation. Engraftment success was evaluated according to local site practice. Time to engraftment corresponded to the first day that criteria were met.|Up to Month 13 (up to 12 months post transplant)|Intent to treat population which included all participants who received plerixafor and had a transplant. One participant's time to engraftment was unknown due to missing lab values.||days||Full Range|Median
730575|NCT00396201|Secondary|Number of Days Post-Transplantation to Polymorphonuclear Leukocyte (PMN) Engraftment|Median number of days to PMN engraftment following transplantation. Engraftment was defined as PMN counts ≥ 0.5*10^9/L for 3 consecutive days or ≥ 1.0*10^9/L for 1 day. Time to engraftment corresponded to the first day that the criteria were met.|Up to Month 13 (up to 12 months post transplant)|Intent to treat population which included all participants who received plerixafor and had a transplant.||days||Full Range|Median
730601|NCT00396279|Secondary|Number of Participants With Anti-Denosumab Antibodies|Validated immunoassays were used to test for the presence of anti-denosumab antibodies throughout the study.|From enrollment until the data cut-off date of April 7 2008; a maximum time of 18 months.|Participants who received at least 1 dose of denosumab and had at least 1 anti-denosumab antibody sample.||participants|||Number
730577|NCT00396201|Secondary|Fold (Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL|The fold increase was measured by fluorescence activated cell sorting (FACS) analysis using local laboratory data and was expressed as a ratio. Fold increase = (pre-apheresis PB CD34+ cells/µL)/(pre-plerixafor dosing PB CD34+ cells/µL).|Days 4-5 (first dose of plerixafor to apheresis)|Intent to treat population which included all participants who received plerixafor and had pre- and post-plerixafor CD34+ cell counts available; 3 participants had missing results data and were not included.||ratio||Standard Deviation|Mean
730578|NCT00396201|Secondary|Proportion of Participants Who Achieved ≥2*10^6 CD34+ Cells/kg Following Treatment With Plerixafor and G-CSF|The proportion of total participants who mobilized ≥2*10^6 CD34+ cells/kg based on data from local laboratories.|Day 5 up to day 9|Intent to treat population which included all participants who received plerixafor.||proportion of participants|||Number
730579|NCT00396201|Secondary|Overall Participant Counts of Adverse Events During the Treatment Period|"Adverse Events were graded by the investigator using the World Health Organization (WHO) Adverse Event Grading Scale and were assessed for severity (mild, moderate, severe and life-threatening) and relatedness (5 steps from 'not related' to 'definitely related') to study treatment. Time frame starts on the first day of G-CSF mobilization to the day prior to chemotherapy/ablative treatment in preparation for transplant.
See the separate Serious Adverse Event section for a summary of AEs the investigator assessed as serious."|Day 0 - approximately day 38|Safety population consisting of all participants who received G-CSF and/or plerixafor.||participants|||Number
730580|NCT00396201|Primary|Proportion of Participants Who Achieved ≥5*10^6 CD34+ Cells/kg Following Treatment With Plerixafor and G-CSF|The proportion of total participants who mobilized ≥5*10^6 CD34+ cells/kg based on data from local laboratories.|Day 5 up to Day 9|Intent to treat population which included all participants who received plerixafor.||proportion of participants|||Number
730581|NCT00396253|Secondary|Change in Blood Flow Rate From Baseline to the End of HD at Visit 2|Change in Blood flow rate (BFR) is the BFR at the end of HD for Visit 2 – BFR at Baseline.|Baseline (beginning of HD at Visit 1) to the end of HD at Visit 2 (2nd consecutive HD session, within 72 hours of Visit 1).|Subjects in the MITT Population Treated with Extended-Dwell Tenecteplase at Visit 1||mL/minute||Standard Deviation|Mean
730582|NCT00396253|Secondary|Percentage of Participants Who Failed Treatment at Visit 1 With a Urea Reduction Ratio ≥ 65% at Visits 2 and 3|"Patients who experienced treatment failure at the end of Visit 1 and were eligible for and treated with extended-dwell tenecteplase at Visit 1 were assessed for Urea Reduction Ratio (URR) at Visits 2 and 3. URR was calculated from blood urea nitrogen (BUN) measurements according to the following:
(Pre-HD BUN) − (Post-HD BUN) * 100% / (Pre-HD BUN)"|Blood urea nitrogen measurements were taken prior to HD and at the end of HD at Visits 2 (2nd HD session, within 72 hours after visit 1) and 3 (3rd HD session, within 72 hours of Visit 2)|Subjects in the MITT Population who were Treated with Extended-Dwell Tenecteplase at Visit 1.||percentage of participants||95% Confidence Interval|Number
730583|NCT00396253|Secondary|Percentage of Participants Who Failed Treatment at Visit 1 With Treatment Success at Visit 2|Patients who failed treatment at Visit 1 and were treated with extended-dwell tenecteplase were analyzed for Treatment Success at Visit 2. Treatment success at Visit 2 was defined as a BFR ≥ 300 mL/min, without line reversal, and increase of ≥ 25 mL/min from baseline BFR, at an associated target arterial pressure in the range of 0 to −280 mmHg, 30 (± 10) minutes prior to the end of HD and at the end of HD.|BFR was measured 30 minutes before the end of HD and at the end of HD at Visit 2 (2nd consecutive HD session, within 72 hours of Visit 1). Baseline BFR was measured at the beginning of HD at Visit 1.|Subjects in the MITT Population who were Treated with Extended-Dwell Tenecteplase at Visit 1.||percentage of participants||95% Confidence Interval|Number
730584|NCT00396253|Secondary|Change in Blood Flow Rate From Baseline to the End of Hemodialysis at Visit 1|Change in Blood flow rate (BFR) is the BFR at the end of HD for Visit 1 – BFR at Baseline.|Baseline (beginning of HD at Visit 1) to the end of HD at Visit 1.|Modified intent to treat (MITT) population||mL/min||Standard Deviation|Mean
730585|NCT00396253|Secondary|Percentage of Participants With Urea Reduction Ratio ≥ 65% at Visit 2|"The urea reduction ratio (URR) at Visit 2 was calculated for those participants who did not receive extended-dwell tenecteplase at Visit 1 from measurements of blood urea nitrogen (BUN) as follows:
(Pre-HD BUN) − (Post-HD BUN) * 100% / (Pre-HD BUN)"|At Visit 2 (2nd consecutive HD session, within 72 hours of Visit 1) samples for blood urea nitrogen measurements were taken prior to HD and after HD was completed.|Modified intent to treat (MITT) population who did not receive extended-dwell tenecteplase at Visit 1.||percentage of participants||95% Confidence Interval|Number
730586|NCT00396253|Secondary|Percentage of Participants With Urea Reduction Ratio ≥ 65% at Visit 1|"The urea reduction ratio (URR) was calculated from measurements of blood urea nitrogen (BUN) as follows:
(Pre-treatment BUN) − (Post-HD BUN) * 100% / (Pre-treatment BUN)
Pre-treatment URR was assessed within 30–60 minutes after the initiation of HD and does not represent a true baseline value."|At Visit 1 (first hemodialysis session in which treatment was administered) samples for blood urea nitrogen measurements were taken at the beginning of HD (prior to treatment administration) and after HD was completed.|Modified intent to treat (MITT) population||percentage of participants||95% Confidence Interval|Number
730587|NCT00396253|Secondary|Percentage of Participants Who Maintained Catheter Function at Visits 2 and 3|For patients with treatment success at Visit 1 or Visit 2, maintenance of catheter function at subsequent visits was defined as a BFR ≥ 300 mL/min and an increase of ≥ 25 mL/min from baseline BFR (without reversal of lines), at an associated target arterial pressure in the range of 0 to -280 mmHg at the beginning of that HD session (within the first 30 minutes).|Maintenance BFR measurements were taken at the beginning of HD at Visit 2 (2nd consecutive HD session, within 72 hours of Visit 1) and Visit 3 (3rd consecutive HD session, within 72 hours of Visit 2).|Modified intent to treat (MITT) population, who had treatment success at Visit 1. The n equals the number of subjects who had treatment success at Visit 1 and had assessment of catheter function for the given visit or who had a missing assessment due to starting the Retreatment course.||percentage of participants||95% Confidence Interval|Number
730613|NCT00396318|Secondary|Percentage of Patients Who Had Cumulative Restoration Rates of CVC Function Following a Single Administration of Tenecteplase|Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|30 minutes after first dose|Modified intent to treat (MITT) population||percentage of participants|||Number
730588|NCT00396253|Primary|Targeted Adverse Events From the Initial Study Drug Administration Through the Start of Visit 2 or Until Instillation of Extended-Dwell Tenecteplase|The primary outcome measure was the number of targeted adverse events, occurring from initial study drug administration through the end of Visit 1 (prior to administration of open-label, extended-dwell tenecteplase) or, for subjects who did not receive open-label, extended-dwell tenecteplase, from initial study administration through the start of Visit 2. Targeted adverse events were defined as intracranial hemorrhage, major bleeding and embolic events, thrombosis, Catheter-related blood stream infection (CRBSIs), and catheter-related complications.|From initial study drug administration to the end of Visit 1 (prior to administration of open-label, extended-dwell tenecteplase) or, for patients who did not receive extended-dwell tenecteplase, from initial study administration to the start of Visit 2.|Modified intent to treat (MITT) population||Events|||Number
730589|NCT00396253|Primary|Percentage of Participants Who Had Treatment Success With Respect to Blood Flow Rate (BFR) at Visit 1|Treatment success is defined as Blood Flow Rate (BFR) ≥ 300 mL/min and an increase of ≥ 25 mL/min from baseline BFR (without reversal of lines), at an associated arterial pressure in the range of 0 to −280 mmHg, 30 (± 10) minutes prior to the end of hemodialysis and at the end of hemodialysis.|Visit 1 (the first hemodialysis session in which treatment was administered). BFR was measured at the beginning of hemodialysis (Baseline measurement) and at 30 minutes prior to the end of hemodialysis and at the end of hemodialysis.|Modified intent to treat (MITT) population, consisting of all enrolled patients who received at least one dose of study drug (tenecteplase).||Percentage of participants|||Number
730590|NCT00396266|Secondary|Maximum Fold Increase in Peripheral Blood CD34+ Cells From Baseline Following Initial Administration of Plerixafor|A pharmacodynamic evaluation to determine the maximum fold increase in peripheral blood CD34+ cells following the initial administration of plerixafor by measuring the fold increase at time points up to 10 hours post plerixafor relative to baseline (immediately prior to plerixafor).|Day 4 (10 hours post first plerixafor dose)|Pharmacodynamic analysis was performed on a subgroup of participants from both treatment arms (1 NHL and 3 MM). The maximum fold increase was observed at 10 hours for all participants.||ratio||Full Range|Median
730591|NCT00396266|Secondary|Single-dose Apparent Volume of Distribution of Plerixafor (Vz/F) in NHL and MM Patients|Evaluation of Vz/F following a single dose of 240 µg/kg plerixafor administered after 4 days of G-CSF mobilization. Vz/F was determined from non-compartmental analysis.|Day 5 - 0 to 10 hours post-first plerixafor dose.|Pharmacokinetic analysis was performed on a subgroup of participants from both treatment arms (5 NHL and 8 MM).||mL||Standard Deviation|Mean
730592|NCT00396266|Primary|Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE)|Number of participants with treatment emergent adverse events (TEAEs) collected from Day 1 (start of G-CSF mobilization) to the day before starting chemotherapy. AEs were graded by the investigator using the World Health Organization (WHO) Adverse Event Grading Scale and were assessed for severity (mild, moderate, severe) and relatedness to study treatment (5 point scale from 'not related' to 'definitely related').|Day 1 to approximately Day 38 (before start of chemotherapy)|Safety population - all participants who received at least 1 dose of plerixafor.||participants|||Number
730593|NCT00396266|Secondary|Single-dose Apparent Clearance of Plerixafor (CL/F)|Evaluation of Cl/F following a single dose of 240 µg/kg plerixafor administered after 4 days of G-CSF mobilization. Cl/F was determined from non-compartmental analysis.|Day 5 - 0 to 10 hours post-first plerixafor dose.|Pharmacokinetic analysis was performed on a subgroup of participants from both treatment arms (5 NHL and 8 MM).||mL/hour||Standard Deviation|Mean
730594|NCT00396266|Secondary|Single-dose Area Under the Concentration-time Curve of Plerixafor From Time 0 to 10 Hours Post-dose (AUC0-10)|Evaluation of AUC0-10 following a single dose of 240 µg/kg plerixafor administered after 4 days of G-CSF mobilization. AUC0-10 was determined from non-compartmental analysis.|Day 5 - 0 to 10 hours post-first plerixafor dose.|Pharmacokinetic analysis was performed on a subgroup of participants from both treatment arms (5 NHL and 8 MM).||ng•h/mL||Standard Deviation|Mean
730595|NCT00396266|Secondary|Single-dose Half-life of Plerixafor (T1/2)|Evaluation of T1/2 following a single dose of 240 µg/kg plerixafor administered after 4 days of G-CSF mobilization. T1/2 was determined from non-compartmental analysis.|Day 5 - 0 to 10 hours post-first plerixafor dose.|Pharmacokinetic analysis was performed on a subgroup of participants from both treatment arms (5 NHL and 8 MM).||hours||Standard Deviation|Mean
730596|NCT00396266|Secondary|Single-dose Time to Maximum Concentration of Plerixafor (Tmax)|Evaluation of Tmax following a single dose of 240 µg/kg plerixafor administered after 4 days of G-CSF mobilization. Tmax was determined from direct observation of the data.|Day 5 - 0 to 10 hours post-first plerixafor dose|Pharmacokinetic analysis was performed on a subgroup of participants from both treatment arms (5 NHL and 8 MM).||hours||Full Range|Median
730597|NCT00396266|Secondary|Single-dose Maximum Observed Concentration of Plerixafor (Cmax)|Evaluation of Cmax following a single dose of 240 µg/kg plerixafor administered after 4 days of G-CSF mobilization. Cmax was determined from direct observation of the data.|Day 5 - 0 to 10 hours post-first plerixafor dose.|Pharmacokinetic analysis was performed on a subgroup of participants from both treatment arms (5 NHL and 8 MM).||ng/mL||Standard Deviation|Mean
730598|NCT00396266|Secondary|Tumor Cell Mobilization in Non-Hodgkin's Lymphoma (NHL) Participants Following Plerixafor Treatment|In a subpopulation of NHL participants, the mobilization of NHL cells was to be evaluated. None of the samples were analyzed due to sample degradation.|Prior to the first (Day 4) and last dose of plerixafor, immediately prior to each apheresis, and 24 hours after the last apheresis.|This analysis was not performed due to sample degradation.|||||
730599|NCT00396266|Secondary|Number of Transplants Resulting In Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post-Transplant|Participants were monitored for polymorphonuclear leukocyte (PMN) engraftment as per the local standard of care. The target for engraftment was 12 days after PBSC transplant and no transplant taking longer than 21 days for engraftment.|2 months|Intent to treat population of participants who had transplants. One participant received a tandem transplant.||number of transplants|Participants||Number
730600|NCT00396266|Secondary|Number of Participants Who Had a ≥ 2-fold Increase in Circulating CD34+ Cells|To determine if NHL and MM patients mobilized with G-CSF (10 µg/kg QD) plus plerixafor will have a ≥2-fold increase in circulating CD34+ cells from time 0 to 11 hours after a dose of plerixafor.|Time 0 to 11 hours after the first dose of plerixafor|"The intent-to-treat population (defined as participants who received at least 1 dose of plerixafor).
One participant excluded from the analysis because data was missing."||participants|||Number
730602|NCT00396279|Secondary|Number of Participants With Adverse Events (AEs)|An adverse event is defined as an undesirable medical occurrence (e.g., sign, symptom, or diagnosis) or worsening of a pre-existing medical condition. A serious adverse event (SAE) is defined by regulatory authorities as one that • is fatal • is life threatening (places the participant at immediate risk of death) • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • other significant medical hazard. The severity of adverse events was assessed according to the Common Terminology Criteria for Adverse Events (CTCAE, version 3.0) based on the following general guideline: Grade 1: Mild AE Grade 2: Moderate AE Grade 3: Severe AE Grade 4: Life-threatening or disabling AE Grade 5: Death related to AE. AEs were assessed by the Investigator for relatedness to study drug.|From the first dose of study drug until the data cut-off date of April 7 2008; a maximum of 18 months|All participants who received at least 1 dose of denosumab.||participants|||Number
730603|NCT00396279|Secondary|Serum Denosumab Trough Concentrations|Serum concentrations of denosumab were measured by a validated conventional sandwich enzyme-linked immunosorbent assay (ELISA).|Blood samples were collected on Days 1 (baseline), 8, 15 and Weeks 5 (Day 29), 9, 13, 25, and 49.|The pharmacokinetics analysis set included participants who received at least 1 dose of denosumab and for whom at least 1 serum denosumab trough concentration was available. 'n' indicates the number of participants with available data at each time point.||ng/mL||Standard Deviation|Mean
730604|NCT00396279|Secondary|Percent Change From Baseline in Serum C-terminus Peptide (of Type 1 Collagen)|Serum C-terminus peptide (of type 1 collagen; CTX1) is a bone turnover marker used to measure the activity of denosumab. Percent change from Baseline in CTX was measured over time.|Baseline and Weeks 5, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, and 81|Efficacy Analysis Set with available data at each time point (n).||percent change||Inter-Quartile Range|Median
730605|NCT00396279|Secondary|Percent Change From Baseline in Urinary N-telopeptide Corrected for Urine Creatinine|Urinary N-telopeptide (of type 1 collagen) corrected for urine creatinine (uNTX/Cr) is a bone turnover marker used to measure the activity of denosumab. Percent change from Baseline in uNTX/Cr was measured over time.|Baseline and Weeks 5, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, and 81|Efficacy Analysis Set with available data at each time point (n).||percent change||Inter-Quartile Range|Median
730606|NCT00396279|Primary|Percentage of Participants With Giant Cell Tumor Response|A treatment response was defined for participants with tissue samples obtained and measured by histopathology as: • at least 90% elimination of giant cells relative to Baseline, or • complete elimination of giant cells in cases where giant cells represent < 5% of tumor cells. A response was defined for participants who have only radiographs (histopathology not available) as lack of progression of the target lesion at week 25 by radiographic measurements compared with Baseline. For participants with both a core biopsy and resected tissue obtained, the sample closest to week 25 was used in the analysis.|From enrollment until 25 weeks|The efficacy analysis set included participants with a Baseline histology assessment and at least 1 postdose histology assessment from weeks 5-25; or a Baseline radiology assessment and at least 1 postdose radiology assessment from weeks 5-25. Evaluable participants had to be on study for at least 28 days after administration of the first dose.||percentage of participants||95% Confidence Interval|Number
730607|NCT00396292|Primary|Number of Subjects Who Achieved 'Success' Meaning a ≥ 2.0 Increase in Hemoglobin||anytime between baseline and the end of study or time to intervention|Modified Intent to Treat Population defined as subjects who received at least 1 dose of randomized study medication, had at least 1 post-baseline hemoglobin assessment, and had postpartum anemia characterized by an average of the 2 baseline central laboratory hemoglobin being <11.0 g/dL||participants|||Number
730608|NCT00396318|Secondary|Percentage of Patients Who Had Cumulative Restoration Rates Restoration Rates of CVC Function at Any Time During the Study and Who Maintained Catheter Patency the Next Time the Catheter Was Assessed, up to 7 Days Following the Last Dose of Tenecteplase|Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|Up to 7 days post-treatment|Number of patients (from MITT population) with restored CVC function during the treatment period||percentage of participants|||Number
730609|NCT00396318|Secondary|Percentage of Patients Who Had Cumulative Restoration Rates of CVC Function Following Administration of One or Two Doses of Tenecteplase|Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|Up to 120 minutes post-treatment (Dose 1 or Dose 2)|Modified intent to treat (MITT) population||percentage of participants|||Number
730610|NCT00396318|Secondary|Percentage of Patients Who Had Cumulative Restoration Rates of CVC Function Following a Second Administration of Tenecteplase|Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|120 minutes after second dose|Modified intent to treat (MITT) population||percentage of participants|||Number
730611|NCT00396318|Secondary|Percentage of Patients Who Had Cumulative Restoration Rates of CVC Function Following a Second Administration of Tenecteplase|Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|30 minutes after second dose|Modified intent to treat (MITT) population||percentage of participants|||Number
730612|NCT00396318|Secondary|Percentage of Patients Who Had Cumulative Restoration Rates of CVC Function Following a Second Administration of Tenecteplase|Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|15 minutes after second dose|Modified intent to treat (MITT) population||percentage of participants|||Number
731071|NCT00401622|Primary|To Assess the Change in A1C From Baseline to Week 52 Between the OneTouch® Ultra®2 and Control BGMS.||From baseline to 52 wks|The study was designed to give 84% power to detect a 0.5% difference in the change of A1C between both groups||Percentage||Standard Error|Least Squares Mean
730614|NCT00396318|Secondary|Percentage of Patients Who Had Cumulative Restoration Rates of CVC Function Following a Single Administration of Tenecteplase|Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|15 minutes after first dose|Modified intent to treat (MITT) population||percentage of participants|||Number
730615|NCT00396318|Primary|Percentage of Patients Who Had Cumulative Restoration Rates of Central Venous Catheter (CVC) Function Following a Single Administration of Tenecteplase|Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|120 minutes after first dose|Modified intent to treat (MITT) population||percentage of participants|||Number
730616|NCT00396331|Secondary|Area Under the Steady-state Plasma Concentration Time Curve From Time Zero to the Last Quantifiable Sample (AUC0-last) on Day 7|Area under the steady-state plasma concentration time curve from time zero to the last quantifiable sample after each plerixafor daily dose of 240 µg/kg, determined using the linear trapezoidal rule.|Days 7-8 (following fourth plerixafor administration)|Participants who provided blood samples for pharmacokinetic (PK) analysis.||ng*h/mL||Standard Deviation|Mean
730617|NCT00396331|Secondary|Area Under the Steady-state Plasma Concentration Time Curve From Time Zero to the Last Quantifiable Sample (AUC0-last) on Day 4|Area under the steady-state plasma concentration time curve from time zero to the last quantifiable sample after each plerixafor daily dose of 240 µg/kg, determined using the linear trapezoidal rule.|Days 4 -5 (following first plerixafor administration)|Participants who provided blood samples for pharmacokinetic (PK) analysis.||ng*h/mL||Standard Deviation|Mean
730618|NCT00396331|Secondary|Time to Maximum Plasma Concentration (Tmax) on Day 7|Time to maximum plasma concentration (Tmax) of plerixafor following daily doses of 240 µg/kg plerixafor, determined directly from the concentration-time data|Day 7 (following fourth plerixafor administration)|Participants who provided blood samples for pharmacokinetic (PK) analysis.||Hours||Full Range|Median
730619|NCT00396331|Secondary|Time to Maximum Plasma Concentration (Tmax) on Day 4|Time to maximum plasma concentration (Tmax) of plerixafor following daily doses of 240 µg/kg plerixafor, determined directly from the concentration-time data|Day 4 (following first plerixafor administration)|Participants who provided blood samples for pharmacokinetic (PK) analysis.||Hours||Full Range|Median
730620|NCT00396331|Secondary|Maximum Observed Plasma Concentration (Cmax) on Day 7|Maximum plasma concentration (Cmax) of plerixafor following daily doses of 240 µg/kg plerixafor, determined directly from the concentration-time data.|Day 7 (following fourth plerixafor administration)|Participants who provided blood samples for pharmacokinetic (PK) analysis.||ng/mL||Standard Deviation|Mean
730621|NCT00396331|Secondary|Maximum Observed Plasma Concentration (Cmax) on Day 4|Maximum plasma concentration (Cmax) of plerixafor following daily doses of 240 µg/kg plerixafor, determined directly from the concentration-time data.|Day 4 (following first plerixafor administration)|Participants who provided blood samples for pharmacokinetic (PK) analysis.||ng/mL||Standard Deviation|Mean
730622|NCT00396331|Secondary|Number of Participants Who Achieved ≥5*10^6 CD34+ Cells/kg Collected During Both Courses of Treatment With Plerixafor and G-CSF|Number of participants who had at least 5*10^6 CD34+ cells/kg collected by apheresis during both the first and the second courses of treatment together.|Day 5 up to Month 6 (up to 7 aphereses in each course of treatment)|Participants who received one course or two courses of plerixafor. Four NHL participants and 3 HD participants had two courses of plerixafor and the sum of CD34+ cells/kg collected in both courses is included.||Participants|||Number
730623|NCT00396331|Secondary|Number of Participants Who Achieved ≥2*10^6 CD34+ Cells/kg Collected During Both Courses of Treatment With Plerixafor and G-CSF|Number of participants who had at least 2*10^6 CD34+ cells/kg collected by apheresis during both the first and the second courses of treatment together.|Day 5 up to Month 6 (up to 7 aphereses in each course of treatment)|Participants who received one course or two courses of plerixafor. Four NHL participants and 3 HD participants had two courses of plerixafor and the sum of CD34+ cells/kg collected in both courses is included.||Participants|||Number
730624|NCT00396331|Secondary|Number of Participants With Non-Hodgkin's Lymphoma (NHL) Who Had Evidence of Tumor Cell Mobilization After G-CSF or Plerixafor Administration|The number of participants with Bcl2 translocation in post-treatment samples.|Up to Day 7|"NHL participants with known follicular or transformed (follicular to diffuse large cell) lymphoma who provided samples for tumor cell mobilization analysis.
Outcome is not reported because there were insufficient samples for analysis."|||||
730625|NCT00396331|Primary|Proportion of Participants Who Achieved ≥5*10^6 CD34+ Cells/kg Following Treatment With Plerixafor and G-CSF|Proportion of participants who reached the target of at least 5*10^6 CD34+ cells/kg collected during up to 7 apheresis.|Day 5 to Day 11 (up to 7 aphereses)|Full analysis set of participants who received at least 1 dose of plerixafor. These results do not include results from the second course of plerixafor treatment and second course of apheresis for the 7 participants who had two courses of apheresis.||Proportion of Participants|||Number
730626|NCT00396331|Secondary|Number of Participants With Durable Engraftment 12 Months After Autologous Transplantation|The number of participants maintaining a durable graft 12 months after transplantation. A durable graft was defined as maintenance of normal blood counts: PLT >50*10^9/L without transfusion for at least 2 weeks prior to the visit; hemoglobin level >= 10 g/dL with no erythropoietin or transfusions for at least 1 month prior to the visit; and absolute neutrophil count (ANC) > 1,000 (1*10^9/L) with no G-CSF for at least 1 week prior to the visit.|Approximately 13 months (12 months post transplant )|Participants who received autologous stem cell transplantation and were evaluable 12 months post transplant. The 3 participants who did not have durable grafts included 2 participants whose PLT level never recovered to >50*10^9/L and 1 who had low hemoglobin at the 12-month visit.||Participants|||Number
730627|NCT00396331|Secondary|Median Number of Days to Platelet (PLT) Engraftment|The number of days from transplantation to successful engraftment as measured by platelet value of >=20*10^9/L for 7 days without transfusion.|Approximately 2 months (1 month post transplant)|Participants who received a transplant and had a successful PLT engraftment. Seven participants (4 with HD, 2 with MM, and 1 with testicular cancer) received a second transplant. Four transplants (2 in participants with NHL and 2 in participants with MM) did not result in PLT engraftment and are therefore not included in the analysis.||Days|Participants|Full Range|Median
730628|NCT00396331|Secondary|Median Number of Days to Polymorphonuclear Leukocyte (PMN) Engraftment|The number of days from transplantation to successful engraftment as measured by PMN >=0.5*10^9 /L for 3 days or >=1.0*10^9 /L for 1 day.|approximately 2 months (1 month post transplant)|Participants who received a transplant and had a successful PMN engraftment. Seven participants (4 with HD, 2 with MM, and 1 with testicular cancer) received a second transplant. Two transplants (1 in a participant with NHL and 1 in a participant with MM) did not result in PMN engraftment and are therefore not included in the analysis.||Days|Participants|Full Range|Median
730629|NCT00396331|Primary|Proportion of Participants Who Achieved ≥2*10^6 CD34+ Cells/kg Following Treatment With Plerixafor and G-CSF|Proportion of participants who reached the target of at least 2*10^6 CD34+ cells/kg collected during up to 7 aphereses.|Day 5 to Day 11 (up to 7 apheresis)|Full analysis set of participants who received at least 1 dose of plerixafor. These results do not include results from the second course of plerixafor treatment and second course of apheresis for the 7 participants who had 2 courses of apheresis.||Proportion of Participants|||Number
730630|NCT00396331|Primary|Overall Participant Counts Summarizing Adverse Events (AEs) During the Treatment Period|Number of participants with adverse events (AEs) collected from Day 1 (start of G-CSF mobilization) to the day before starting chemotherapy. AEs were graded by the investigator using the World Health Organization (WHO) Adverse Event Grading Scale and were assessed for severity (mild, moderate, severe, life-threatening) and relatedness to study treatment (5 point scale from 'not related' to 'definitely related').|Day 1 to approximately day 38|Safety population of all participants who received at least 1 dose of plerixafor.||Participants|||Number
730631|NCT00396383|Post-Hoc|Number of Participants Who Achieved ≥2*10^6 CD34+ Cells/kg|Number of participants achieving ≥ 2*10^6 CD34+ cells/kg during apheresis for up to 4 consecutive days. Apheresis was performed six hours following treatment with plerixafor 240 µg/kg (alone). Total was calculated as the sum of all daily values collected from central laboratory data over up to 4 apheresis days.|Day 1 up to day 4|All participants who received plerixafor||participants|||Number
730632|NCT00396383|Secondary|Number of Participants With a Durable Graft at 12 Months Post Transplantation|Graft durability was assessed by the Investigator based on complete blood count (CBC) and differential analyses at 12 months post transplantation.|Approximately month 13|Intent to treat population includes participants who received plerixafor, underwent transplantation, and were evaluable 12 months post transplant.||participants|||Number
730633|NCT00396383|Secondary|Number of Transplantations That Achieved Platelet (PLT) Engraftment Grouped by Days to Engraftment|Platelet (PLT) engraftment was defined as a PLT count of ≥ 20*10^9/L for 7 days without transfusion. Days to engraftment corresponded to the first day that the criteria were met after transplantation.|Approximately 2 months|Intent to treat population includes participants who received plerixafor and underwent transplantation. One participant had two transplants. One participant did not have PLT samples collected (included as 'unknown' in data table).||transplantations|Participants||Number
730634|NCT00396383|Secondary|Number of Transplantations That Achieved Polymorphonuclear Leukocyte (PMN) Engraftment Grouped by Days to Engraftment|Polymorphonuclear cell (PMN) engraftment was defined as a PMN count ≥ 0.5*10^9/L for 3 consecutive days or ≥ 1*10^9/L for 1 day. Days to engraftment corresponded to the first day that the criteria were met after transplantation.|Approximately 2 months|Intent to treat population includes participants who received plerixafor and underwent transplantation. One participant had two transplants.||transplantations|Participants||Number
730635|NCT00396383|Primary|Participant Counts of Summarized Adverse Events (AE) During Treatment|Participant counts of summarized adverse events (AEs) which occurred from the first dose of plerixafor up to the day prior to chemotherapy/ablative treatment. Events were graded according to World Health Organization criteria: Mild (awareness of sign or symptom, but easily tolerated), Moderate (discomfort enough to cause interference with usual activity), Severe (incapacitating with inability to work or do usual activity).|1 month|All participants who received plerixafor||participants|||Number
730636|NCT00396383|Primary|Number of Participants Who Achieved ≥4*10^6 CD34+ Cells/kg|Number of participants achieving a target of ≥ 4*10^6 CD34+ cells/kg during apheresis for up to 4 consecutive days. Apheresis was performed six hours following treatment with plerixafor 240 µg/kg (alone). Target was calculated as the sum of all daily values collected from central laboratory data over up to 4 apheresis days.|Day 1 up to day 4|All participants who received plerixafor||participants|||Number
730637|NCT00396409|Secondary|Lung Function as Assessed by Peak Expiratory Flow (PEF)|The spirometric parameter Peak Expiratory Flow (PEF) was measured during grass pollen season before each injection of Depigoid. PEF was collected in the patient diary at seven days after visit 22, 23 and 24 as well as 35, 36 and 37. For analyzing purposes these data were averaged after the respective visits. Missing PEF-values from the patient diary were not replaced.|Assist during 2007 and 2008 pollen season|Intent-to-Treat (ITT)||liters per minute (L/min)||Standard Deviation|Mean
730638|NCT00396409|Secondary|Lung Function as Assessed by Forced Expiratory Volume in One Second (FEV1)|The spirometric parameter Forced Expiratory Volume in One Second (FEV1) was measured during grass pollen season before each injection of Depigoid.|Assist during 2007 and 2008 pollen season|Intent-to-Treat (ITT)||milliliters (mL)||Standard Deviation|Mean
730639|NCT00396409|Secondary|Work Productivity and Activity Impairment|The Work Productivity and Activity Impairment questionnaire measures time missed from work, impairment of work and regular activities. It consists of 6 items. The outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity. The minimum value is 0 (0 %), the maximum value is 1 (100%). The recall time is 1 week. For this study WPAI-AA was used defining the specific health problem as allergic asthma, which has been validated by the instrument owner.|52 Weeks (2007) and 104 Weeks (2008) after completion of core study|Intent-to-Treat (ITT)||units on a scale||Standard Deviation|Mean
730640|NCT00396409|Secondary|Asthma Quality of Life Questionnaire (AQLQ) and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) - Clinical Differences to Baseline|Both the AQLQ and RQLQ clinical differences were categorized as important, moderate, or meaningful improvement; no clinical change; meaningful, moderate, or important impairment. Clinically important differences in scores between any two assessments have been determined by the authors of the AQLQ and RQLQ. Changes in scores of 0.5 to 1.0 are considered clinically meaningful; 1.0 to 1.5 as moderate and > 1.5 as marked clinically important differences for any individual domain or for the overall summary score.|Baseline of core study and 52 Weeks (2007) and 104 Weeks (2008) after completion of core study|Intent-to-Treat (ITT)||participants|||Number
730641|NCT00396409|Secondary|Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)|The Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) is a 28-item disease specific questionnaire designed to measure functional impairments that are most important to patients with rhinoconjunctivitis. It consists of 7 domains (activities, sleep, common complaints, practical problems, nasal symptoms, ocular symptoms, and emotions). Patients recall their experiences during the previous week and to score each item on a 7-point scale. The overall RQLQ score is the mean response to all 28 questions (low=1, high=7). Higher values represent worse quality of life.|52 Weeks (2007) and 104 Weeks (2008) after completion of core study|Intent-to-Treat (ITT)||units on a scale||Standard Deviation|Mean
730642|NCT00396409|Secondary|Asthma Quality of Life Questionnaire (AQLQ)|The Asthma Quality of Life Questionnaire (AQLQ) is a 32-item disease specific questionnaire designed to measure functional impairments that are most important to patients with asthma. It consists of 4 domains (symptoms, emotions, exposure to environmental stimuli and activity limitation). Patients are asked to recall their experiences during the previous 2 weeks and to score each item on a 7-point scale. The overall AQLQ score is the mean response to all 32 questions (low=1, high=7). Higher values represent better quality of life.|52 Weeks (2007) and 104 Weeks (2008) after completion of core study|Intent-to-Treat (ITT)||units on a scale||Standard Deviation|Mean
730643|NCT00396409|Secondary|Asthma Control Questionnaire (ACQ)|The Asthma Control Questionnaire (ACQ) was developed and validated for assessing asthma symptom control in patients in clinical trials as well as for individuals in clinical practice. It is a simple questionnaire consisting of seven questions assessing symptoms, airway caliber and rescue β2-agonist use. It uses a 7-point scale. The possible minimum value is 1, the possible maximum value is 7. Higher values represent worse asthma control and quality of life, respectively.|52 Weeks (2007) and 104 Weeks (2008) after completion of core study|Intent-to-Treat (ITT)||units on a scale||Standard Deviation|Mean
730644|NCT00396409|Secondary|Percentage of Participants by Global Evaluation of Treatment Effectiveness (GETE) Assessment Category Performed by the Patient|The patient's assessment of the global evaluation of treatment effectiveness (GETE) using a five point scale, which evaluates change in asthma control/symptoms. GETE is scored as 1=’excellent’, 2=’good’, 3=’moderate’, 4=’poor’, 5=’worsening’ and (.)=’missing’).|52 Weeks (2007) and 104 Weeks (2008) after completion of core study|Intent-to-Treat (ITT)||percentage of participants|||Number
730645|NCT00396409|Secondary|Percentage of Participants by Global Evaluation of Treatment Effectiveness (GETE) Assessment Category Performed by the Investigator|The investigator's assessment of the global evaluation of treatment effectiveness (GETE) using a five point scale, which evaluates change in asthma control/symptoms. GETE is scored as 1=’excellent’, 2=’good’, 3=’moderate’, 4=’poor’, 5=’worsening’ and (.)=’missing’).|52 Weeks (2007) and 104 Weeks (2008) after completion of core study|Intent-to-Treat (ITT)||percentage of participants|||Number
730646|NCT00396409|Secondary|Asthma/Rhinoconjunctivitis Rescue Medication Score|Asthma/Rhinoconjunctivitis rescue medication score is a component of symptom load. Patients were advised that between visits they could take short acting β-2 agonist rescue medication as initial rescue medication for symptoms of intercurrent bronchospasm. Patients were advised that between visits they could take rescue medication (systemic antihistamines) on an as-needed basis for symptoms of grass pollen allergic rhinoconjunctivitis. The symptom load and all its components were based on the patient’s entries in their diaries.|Recorded daily during the 2007 and 2008 pollen season|Intent-to-Treat (ITT)||units on a scale||Standard Deviation|Mean
730647|NCT00396409|Secondary|Asthma/Rhinoconjunctivitis Symptom Severity Score|The symptom severity score was defined as the mean of the daily symptom severity scores (asthma symptoms during the day, asthma symptoms at night, rhinitis symptoms, and conjunctivitis symptoms) during the pollen season. The daily symptom severity scores were evaluated daily by the patient using a 4-point scale (0 = none (no symptom), 1 = mild, 2 = moderate, 3 = severe) and were recorded in a patient diary. The possible minimum value for the Asthma/Rhinoconjunctivitis Symptom Severity Score is 0, and the possible maximum value is 3. Higher values represent a worse outcome.|Recorded daily during the 2007 and 2008 pollen season|Intent-to-Treat (ITT)||units on a scale||Standard Deviation|Mean
730648|NCT00396409|Primary|Daily Symptom Load|The daily symptom load (low=0, high=unbounded) represents the daily combined asthma and rhinoconjunctivitis symptom severity scores plus the daily asthma rescue medication score based on patient diary entries. A higher score indicates a worse patient asthma condition. Symptoms (e.g. - difficulty breathing, cough, tightness of chest, sneezing, itchy nose, red eyes, etc.) were evaluated daily by the patient using a 4-point scale (0=no symptom, 1=mild, 2=moderate, 3=severe). Point values were assigned by specific rescue medication usage. The daily scores were averaged over pollen days by site.|Recorded daily during the 2007 and 2008 pollen season|Intent-to-Treat (ITT). The complete analysis population who consisted of all patients that received at least one dose of study drug was used for all efficacy and safety evaluations in this extension period.||units on a scale||Standard Deviation|Mean
730649|NCT00396565|Secondary|Change From Baseline in Clinical Global Impression Scale (CGI-S)|The CGI-S rating scale is a 7-point global assessment with scores as follows: 1 – Not ill, 2 – Very Mild, 3 – Mild, 4 – Moderate, 5 – Marked, 6 – Severe, and 7 – Extremely Severe.|Baseline and 6 weeks|Full Analysis Set excludes subjects who didn’t receive test drug or didn't have post-treatment efficacy data. The Olanzapine(OLZ) group was set as an active drug group to examine clinical position of paliperidone(PAL) ER, and the superiority or non-inferiority of PAL ER 6mg to OLZ 10mg wasn't verified. LOCF imputation method was applied.||scores on a scale||Standard Error|Mean
730650|NCT00396565|Secondary|Proportion of Responders (≥30% Decrease in Total Positive and Negative Syndrome Scale [PANSS])|Responders are subjects with 30% or more reduction from baseline in total PANSS score. PANSS is a medical scale that assesses various symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill).|Baseline and 6 weeks|Full Analysis Set excludes subjects who didn’t receive test drug or didn't have post-treatment efficacy data. The Olanzapine(OLZ) group was set as an active drug group to examine clinical position of paliperidone(PAL) ER, and the superiority or non-inferiority of PAL ER 6mg to OLZ 10mg wasn't verified. LOCF imputation method was applied.||Percentage of participants|||Number
731043|NCT00401401|Secondary|Overall Response|Tumour response according to RECIST criteria J Natl Cancer Inst 2000;92:205-16 assessed by CT/MRI. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the longest diameter of target lesions; Overall Response (OR), CR+PR|Up to 3 years|||Participants|||Number
730651|NCT00396565|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - General Psychopathology Subscale Score|The PANSS General Psychopathology Subscale Score assesses 16 general psychopathology symptoms. The symptoms are rated on a 7-point scale, with a range of 16 (absent) to 112 (extreme psychopathology).|Baseline and 6 weeks|Full Analysis Set excludes subjects who didn’t receive test drug or didn't have post-treatment efficacy data. The Olanzapine(OLZ) group was set as an active drug group to examine clinical position of paliperidone(PAL) ER, and the superiority or non-inferiority of PAL ER 6mg to OLZ 10mg wasn't verified. LOCF imputation method was applied.||scores on a scale||Standard Deviation|Mean
730652|NCT00396565|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score|The PANSS Negative Subscale assesses seven negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).|Baseline and 6 weeks|Full Analysis Set excludes subjects who didn’t receive test drug or didn't have post-treatment efficacy data. The Olanzapine(OLZ) group was set as an active drug group to examine clinical position of paliperidone(PAL) ER, and the superiority or non-inferiority of PAL ER 6mg to OLZ 10mg wasn't verified. LOCF imputation method was applied.||scores on a scale||Standard Deviation|Mean
730653|NCT00396565|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score|The PANSS Positive Subscale assesses seven positive-symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).|Baseline and 6 weeks|Full Analysis Set excludes subjects who didn’t receive test drug or didn't have post-treatment efficacy data. The Olanzapine(OLZ) group was set as an active drug group to examine clinical position of paliperidone(PAL) ER, and the superiority or non-inferiority of PAL ER 6mg to OLZ 10mg wasn't verified. LOCF imputation method was applied.||scores on a scale||Standard Deviation|Mean
730654|NCT00396565|Primary|Change From Baseline in the Total Positive and Negative Syndrome Scale (PANSS).|PANSS is a medical scale that assesses various symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill).|Baseline and 6 weeks|Full Analysis Set excludes subjects who didn’t receive test drug or didn't have post-treatment efficacy data. The Olanzapine (OLZ) group was set as an active drug group to examine clinical position of paliperidone (PAL) ER, and the superiority or non-inferiority of PAL ER 6mg to OLZ 10mg wasn't verified. LOCF imputation method was applied.||scores on a scale||Standard Deviation|Mean
730655|NCT00396591|Secondary|Safety - Number of Participants With Adverse Events (AE)|All AEs regardless of seriousness or relationship to study treatment, spanning from the first administration of study treatment until 60 days after the last administration of study treatment, were recorded, and followed until resolution or stabilization. The number of participants with all treatment emergent adverse events (TEAE), serious adverse events (SAE), TEAE leading to death, and TEAE leading to permanent treatment discontinuation are reported.|up to 60 days after last dose of treatment (approximately 2 years), or until TEAE was resolved or stabilized|All participants who received at least part of 1 dose of the study treatment.||participants|||Number
730656|NCT00396591|Secondary|Number of Participants With a Positive Anti-drug Antibody Response|"Anti-drug antibodies in participant's serum were measured using 2 different methods
an Enzyme Linked Immunosorbent Assay (ELISA) in which the lower limit of detection (LLOD) was 238.4 ng/mL; and
an Electrochemiluminescence-based, Bridging Assay in which the validated LLOD was about 5.4 ng/mL in the absence of aflibercept and about 25.2 ng/mL in the presence of 20 μg/mL of aflibercept.
Participants with detectable anti-drug antibodies by either method were considered to have a positive anti-drug antibody response."|up to 60 days after the last dose of treatment|Participants who received at least part of 1 dose of aflibercept and had evaluable blood samples||participants|||Number
730657|NCT00396591|Secondary|Overall Survival (OS) Time|OS time was the time interval between the date of registration to the date of death from any cause. Median OS was estimated from Kaplan-Meier curves. Participants who died after efficacy data cutoff date (6 months postregistration) were censored at the data cutoff date.|up to 6 months post-registration|All participants were analyzed. 5 participants who died after efficacy data cutoff date (6 months postregistration) were censored at the data cutoff date.||days|Participants|95% Confidence Interval|Median
730658|NCT00396591|Secondary|Progression-free Survival (PFS) Time|"According to the Response Evaluation Criteria in Solid Tumors [RECIST], progression was at least a 20% increase in the sum of the longest diameter (LD) of tumors, compared to smallest sum LD recorded since treatment started, or the appearance of one or more new tumors.
PFS time was interval from the date of registration to the date of tumor progression or death from any cause, whichever was earlier. Median PFS time was estimated from Kaplan-Meier Plots.
If participants were alive and progression-free at 6 months postregistration, they were censored for PFS."|up to 6 months post-registration|Participants with a PFS event (tumor progression or death) were analyzed.||days||95% Confidence Interval|Median
730659|NCT00396591|Secondary|60-day Frequency of Paracentesis (FOP)|FOP was the total number of paracenteses performed within the first 60 days postregistration. For participants who had withdrawn after registration but prior to the 60-day cutoff date, the withdrawal would have been regarded as a paracentesis event and the 60-day FOP normalized and calculated as the nearest integer of the value corresponding to 60 × number of paracenteses / x, where x represents the number of days on study.|up to 60 days post-registration|||paracenteses||Standard Deviation|Mean
730660|NCT00396591|Secondary|Time to Repeat Paracentesis (TRP)|TRP is the number of days between the date of registration and the date of the first postregistration paracentesis. Median TRP was estimated from Kaplan-Meier curves. For participants who did not undergo a postregistration paracentesis while on study, TRP was censored at the end of the treatment period (last dose + 1 cycle), at the last visit known without repeat paracentesis, at 6 months postregistration, or at death, whichever was earlier.|up to 6 months from registration|All participants were analyzed. 8 had one or more paracentesis events. Participants with no paracentesis events were censored at the end of the treatment period (last dose + 1 cycle).||days|Participants|95% Confidence Interval|Median
730996|NCT00400881|Primary|Duration of Weaning Time|Weaning time was determined as number of days from the day of the first SBT(spontaneous breathing trial) to the day of extubation. All patients were followed until extubation.|days|All patients completing the SBT were analysed except for two patients in each group that were excluded from analysis per protocol due to re-intubation due to upper airway obstruction.||days||Standard Deviation|Mean
730661|NCT00396591|Primary|Percentage of Participants With a Repeat Paracentesis Response (RPR)|"RPR was defined as at least a two-fold increase in the time to repeat paracentesis (TRP) as compared to the average duration of the 2 intervals between the 3 most recent paracenteses prior to study registration (ie, the baseline interval of paracentesis).
Percentage of participants with a repeat paracentesis response were the number of participants with RPR / number of total participants * 100."|up to 2 years post-registration|||percentage of participants||95% Confidence Interval|Number
730662|NCT00396630|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs).|"A serious adverse event (SAE) is any untoward medical occurrence that:
results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above."|Up to Visit 4.|The analyses were performed on the Total Vaccinated Cohort||subjects|||Number
730663|NCT00396630|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs).|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Within 31 days after any doses.|The analyses were performed on the Total Vaccinated Cohort||subjects|||Number
730664|NCT00396630|Secondary|Number of Subjects With Gastroenteritis (GE) and Rotavirus Gastroenteritis (RV GE) Episodes.|"GE episodes were defined as diarrhea (passage of three or more looser than normal stools within a day) with or without vomiting.
RV GE episodes were defined as GE episodes for which the stool sample temporally closest to the onset day of the GE episode was positive for rotavirus by Enzyme Linked Immunosorbent Assay (ELISA)."|Until Visit 4 (Week 17) for GE and until Visit 3 (Week 13) for RV GE.|The analyses were performed on the Total Vaccinated Cohort||subjects|||Number
730665|NCT00396630|Secondary|Anti-rotavirus IgA Antibody Concentration.|Anti-rotavirus IgA antibody concentrations are given as geometric mean concentrations (GMC) with 95% Confidence Intervals.|At Visit 3 (Week 13).|The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity.||U/mL||95% Confidence Interval|Geometric Mean
730666|NCT00396630|Secondary|Anti-rotavirus Immunoglobulin A (IgA) Antibody Seroconversion.|Number of initially seronegative subjects with anti-rotavirus IgA antibody concentration ≥ 20 Units/milliliter (U/mL), 1 month after the second dose.|At Visit 3 (Week 13).|The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity.||subjects|||Number
730667|NCT00396630|Secondary|Live Viral Vaccine Load in the Stool of the Twin Receiving Placebo in Case of Transmission.||During the entire study period.||||||
730668|NCT00396630|Secondary|Analysis by Sequencing of Genomic Mutations in the HRV Vaccine Strain After Transmission.||During the entire study period.||||||
730669|NCT00396630|Secondary|Duration of Human Rotavirus (HRV) Shedding Per Study Group.|Duration of shedding in the Placebo Group= number of days between first and last stool sample positive (+) for rotavirus (RV) antigen and in the Rotarix Group= number of days between the day of vaccination and the date of last stool sample + for RV antigen.|From Day 0 up to Week 13|The analysis was performed on the According To Protocol analysis for immunogenicity, on the twins whose placebo recipient had at least one stool sample positive for the rotavirus strain.||Number of days||Inter-Quartile Range|Median
730670|NCT00396630|Primary|Presence of Rotavirus Vaccine Strain in Any Stool Sample From Twin Receiving Placebo.|Number of subjects in the Placebo Group with rotavirus vaccine strain in at least one stool sample.|On the day of each vaccine/placebo dose, then three times weekly for 6 consecutive weeks starting after each vaccine/placebo dose and on the day of Visit 3.|The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity.||subjects|||Number
730671|NCT00396656|Secondary|Arterial Pressure Waveform Pulse Wave Velocity at the End of Treatment|Using applanation tonometry, the arterial pulse form measured at the wrist was analyzed using computerized pulse wave analysis. The arterial pressure waveform has two components; the first is the forward traveling wave when the left ventricle contracts and the second is the reflected wave returning from the periphery. Pulse wave velocity is the speed of the forward traveling wave and can be used as a measure of arterial stiffness since the more rigid the wall of the artery, the faster the wave moves.|At end of each treatment period (Week 21 and Week 43)|Intent-to-treat (ITT) population: All randomized patients with at least one valid post-baseline primary efficacy measurement in both treatment periods.||Meters per second||Standard Deviation|Mean
730672|NCT00396656|Secondary|Arterial Pressure Waveform Augmentation Index at the End of Treatment|Using applanation tonometry, the arterial pulse form measured at the wrist was analyzed using computerized pulse wave analysis. The arterial pressure waveform has two components; the first is the forward traveling wave when the left ventricle contracts and the second is the reflected wave returning from the periphery. The augmentation index is the ratio of the first and second systolic peaks and is used as a surrogate measure of arterial stiffness.|At end of each treatment period (Week 21 and Week 43)|Intent-to-treat (ITT) population: All randomized patients with at least one valid post-baseline primary efficacy measurement in both treatment periods.||Ratio||Standard Deviation|Mean
730673|NCT00396656|Secondary|Mean Post-treatment Microcirculation at NaCl Injected Sites|10 µl of NaCl was injected intra-dermally at 2 sites on the forearms. Microcirculation was measured using laser doppler velocimetry before and 12 times in the 30 minutes following injection. The mean difference of the 12 post-injection measurements to the pre-injection measurement was calculated. A mean for the 2 NaCl sites was calculated. Microcirculation was measured in perfusion units which is an arbitrary measure specific to each laser doppler scanner.|At end of each treatment period (Week 21 and Week 43)|Intent-to-treat (ITT) population: All randomized patients with at least one valid post-baseline primary efficacy measurement in both treatment periods.||Perfusion units||Standard Deviation|Mean
730674|NCT00396656|Secondary|Difference in Mean Post-treatment Microcirculation at a Sodium Nitroprusside Injected Site Compared to NaCl Injected Sites|10 µl of sodium nitroprusside at a concentration of 10-7 M was injected intra-dermally at 1 site on the forearms. NaCl was injected at 2 sites on the forearms. Microcirculation was measured using laser doppler velocimetry before and 12 times in the 30 minutes following injection. The mean difference of the 12 post-injection measurements to the pre-injection measurement was calculated. A mean for the 2 NaCl sites was calculated and compared to the sodium nitroprusside mean. Microcirculation was measured in perfusion units which is an arbitrary measure specific to each laser doppler scanner.|At end of each treatment period (Week 21 and Week 43)|Intent-to-treat (ITT) population: All randomized patients with at least one valid post-baseline primary efficacy measurement in both treatment periods.||Perfusion units||Standard Deviation|Mean
730675|NCT00396656|Secondary|Difference in Mean Post-treatment Microcirculation at Acetylcholine (ACH) Plus L-NMMA Injected Sites Compared to NaCl Injected Sites|10 µl of acetylcholine (ACH) at 3 concentrations (10-7, 10-8, 10-9 M) plus 10 µl L-NMMA (10-6 M) was injected intra-dermally at 3 sites on the forearms. NaCl was injected at 2 sites. Microcirculation was measured using laser doppler velocimetry before and 12 times in the 30 minutes following injection. The mean difference of the 12 post-injection measurements to the pre-injection measurement was calculated. Means for the 3 ACH and the 2 NaCl sites were calculated and compared. Microcirculation was measured in perfusion units which is an arbitrary measure specific to each laser doppler scanner.|At end of each treatment period (Week 21 and Week 43)|Intent-to-treat (ITT) population: All randomized patients with at least one valid post-baseline primary efficacy measurement in both treatment periods.||Perfusion units||Standard Deviation|Mean
730676|NCT00396656|Primary|Difference in Mean Post-treatment Microcirculation at Acetylcholine (ACH) Injected Sites Compared to NaCl Injected Sites|10 µl of acetylcholine (ACH) at 3 concentrations (10-7, 10-8, 10-9 M) was injected intra-dermally at 3 sites on the forearms. NaCl was injected at 2 sites on the forearms. Microcirculation was measured using laser doppler velocimetry before and 12 times in the 30 minutes following injection. The mean difference of the 12 post-injection measurements to the pre-injection measurement was calculated. Means for the 3 ACH and the 2 NaCl sites were calculated and compared. Microcirculation was measured in perfusion units which is an arbitrary measure specific to each laser doppler scanner.|At end of each treatment period (Week 21 and Week 43)|Intent-to-treat (ITT) population: All randomized patients with at least one valid post-baseline primary efficacy measurement in both treatment periods.||Perfusion units||Standard Deviation|Mean
730677|NCT00396812|Primary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 48|ESR is a blood test used to monitor therapy in inflammatory diseases such as rheumatoid arthritis and reflects acute phase reactant levels. Active disease in RA is defined by an ESR greater than 30 mm/hr. Change from baseline is computed as the value at Week 48 minus the baseline value. A negative value in change from baseline indicates an improvement.|Baseline (Day 0), Week 48|All subjects who receive at least one dose of study treatment and attended Day 0 and Week 48 visits||mm/hr||Standard Deviation|Mean
730678|NCT00396812|Primary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 48|HAQ-DI is derived based on the mean of individual scores in 8 categories of daily living activities (using 20 questions). Each question is scored 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do). In addition, category scores are modified if an aid or device is used, for example, a walker or wheelchair, or help is received from another person in the daily living activities. If an aid or device is used or help is received then a category score of 0 or 1 increases to a category score of 2. A category score of 3 remains a 3 regardless of aids, devices, or help. Scores from each of the 8 categories are totaled. The total score can range from 0 to 24. Change from baseline is computed as the total score at Week 48 minus the baseline total score. A negative value in change from baseline indicates an improvement.|Baseline (Day 0), Week 48|All subjects who receive at least one dose of study treatment and attended Day 0 and Week 48 visits||Units on a scale||Standard Deviation|Mean
730679|NCT00396812|Primary|Change From Baseline in the Short Form 36 (SF-36) Physical and Mental Health Component Summary Scores (PCS and MCS) at Week 48|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from baseline is computed as the value at Week 48 minus the baseline value. A positive value in change from Baseline indicates an improvement and a negative value worsening.|Baseline (Day 0), Week 48|All subjects who receive at least one dose of study treatment and attended Day 0 and Week 48 visits||Units on a scale||Standard Deviation|Mean
730680|NCT00396812|Primary|Change From Baseline in Physician’s Global Assessment of Patient’s Disease Activity- Visual Analog Scale (PhGADA-VAS) at Week 48|Change from Baseline in PhGADA-VAS (0 to 100 millimeters visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as the value at Week 48 minus the Baseline value. A negative value in change from Baseline indicates an improvement.|Baseline (Day 0), Week 48|All subjects who receive at least one dose of study treatment and attended Day 0 and Week 48 visits||mm||Standard Deviation|Mean
730681|NCT00396812|Primary|Change From Baseline in Patient’s Global Assessment of Disease Activity- Visual Analog Scale (PtGADA-VAS) at Week 48|Change from Baseline in PtGADA-VAS (0 to 100 millimeters visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as the value at Week 48 minus the Baseline value. A negative value in change from Baseline indicates an improvement.|Baseline (Day 0), Week 48|All subjects who receive at least one dose of study treatment and attended Day 0 and Week 48 visits||mm||Standard Deviation|Mean
730682|NCT00396812|Primary|Change From Baseline in Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS) at Week 48|Change from Baseline in PAAP-VAS (0 to 100 millimeters visual analog scale, 0 being no pain and 100 being most severe pain) is computed as the value at Week 48 minus the Baseline value. A negative value in change from Baseline indicates an improvement.|Baseline (Day 0), Week 48|All subjects who receive at least one dose of study treatment and attended Day 0 and Week 48 visits||mm||Standard Deviation|Mean
730683|NCT00396812|Primary|Change From Baseline in Swollen Joint Count at Week 48|Swollen Joint Count (SJC) is calculated based on swelling response of 28 joints. SJC possible values range from 0 to 28. A lower SJC indicates less joint swelling. Change from baseline is computed as Week 48 value minus baseline value. A negative value in change from baseline indicates an improvement.|Baseline (Day 0), Week 48|All subjects who receive at least one dose of study treatment and attended Day 0 and Week 48 visits||Units on a scale||Standard Deviation|Mean
730684|NCT00396812|Primary|Change From Baseline in Tender Joint Count Score at Week 48|Tender Joint Count (TJC) is calculated based on tenderness response of 28 joints. TJC possible values range from 0 to 28. A lower TJC indicates less joint tenderness. Change from baseline is computed as Week 48 value minus baseline value. A negative value in change from baseline indicates an improvement.|Baseline (Day 0), Week 48|All subjects who receive at least one dose of study treatment and attended Day 0 and Week 48 visits||Units on a scale||Standard Deviation|Mean
731035|NCT00401258|Secondary|Hamilton Anxiety Rating Scale||At visits 2, 5, 7, and 9||||||
731036|NCT00401258|Secondary|Hamilton Depression Rating Scale||At first visit only||||||
731037|NCT00401258|Secondary|Clinical Global Impression Scale||At each visit||||||
730685|NCT00396812|Primary|Change From Baseline in the Disease Activity Score- Erythrocyte Sedimentation Rate (DAS28-ESR) at Week 48|The DAS28-ESR is a score on a scale (0 to 10) that is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity (mm), and ESR (mm/hour). Lower score indicates less disease activity. Flares in disease activity are defined as an increase in this score of greater than 1.2 and remission is defined as achieving a DAS28-ESR score of less than 2.6.|Baseline (Day 0), Week 48|All subjects who receive at least one dose of study treatment and attended Day 0 and Week 48 visits||Score on a scale||Standard Deviation|Mean
730686|NCT00396877|Secondary|Number of Participants According to Bleeding Type/Etiology|For all reported bleeding events, the type and the etiology of the bleeding event were collected. Participants who experienced bleeding events during the 'on-treatment period' were counted by bleeding type and etiology. Participants who had multiple bleedings could be counted several times.|From randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever comes first|The analysis was performed on the same population as previously (i.e. exposed population).||participants|||Number
730687|NCT00396877|Secondary|Number of Participants With Bleeding Events|"Bleeding events spanning from signature of the Informed Consent Form up to the last visit were collected as for any Adverse Event.
The 'on-treatment' period was defined as the period from randomization up until 28 days after treatment discontinuation or final follow-up visit, whichever came first, and participants who experienced bleeding events during that period were counted."|From randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever comes first|The analysis was performed on the exposed population (i.e. all randomized participants who received at least one dose of study drug regardless of the amount of treatment received). Participants were included in the treatment group according to the treatment received.||participants|||Number
730688|NCT00396877|Primary|Number of Participants Reaching Primary Endpoint Criteria (First Occurrence of Death / Shunt Thrombosis / Cardiac Procedure < 120 Days Considered of Thrombotic Nature)|"The primary endpoint was the first occurence of any of the following events: Death (including heart transplant); Shunt thrombosis requiring intervention; Hospitalization for bi-directional Glenn procedure or any cardiac related intervention prior to 120 days of age following an event or a shunt narrowing considered to be of thrombotic nature by the blinded adjudication committee.
Only the first event was counted."|Median follow-up of 5.8 months (up to a maximum of 12 months after randomization)|The analysis was performed on the intent-to-treat (ITT) population (i.e. all randomized participants irrespective of whether or not the participant actually received study drug or the participant's compliance with the study protocol). Participants were included in the treatment group to which they were originally allocated.||participants|||Number
730689|NCT00396981|Secondary|Target Aneurysm Recurrence||5 years|||participants|||Number
730690|NCT00396981|Secondary|Target Aneurysm Recurrence||3 years|||participants|||Number
730691|NCT00396981|Secondary|Target Aneurysm Recurrence||2 years|||participants|||Number
730692|NCT00396981|Secondary|Technical Procedure Success||Post-procedure|||percentage of participants|||Number
730693|NCT00396981|Secondary|Neurological Assessments|"The changes in modified Rankin Scores from pre-procedure to 12-month were measured. the outcome below reflects same or better."|12 months|||percentage of participants|||Number
730694|NCT00396981|Secondary|Angiographic Assessments|"Number of participants with angiographic assessment of complete obliteration."|Reintervention or 12 months|||participants|||Number
730695|NCT00396981|Primary|Target Aneurysm Recurrence (TAR) Defined as Clinically Relevant Recurrence Resulting in Target Aneurysm Reintervention, Rupture/Re-rupture and/or Death From an Unknown Cause.||12 months|A totoal of 630 subjects were planned for the study. All enrolled MAPS trial subjects' data is included in the ITT anaylsis except for four subjects who were excluded due to the following reasons: one subject did not have an aneurysm and three subjects', a the request of the IRB, due to non GCP compliance in obtaining the inofrmed consent.||participants|||Number
730696|NCT00397033|Other Pre-specified|Change in Young Mania Rating Scale (YMRS) With Baseline YMRS Total Score >= 16|11-item scale (elevated mood, increased motor activity, sexual interest, sleep, irritability, speech [rate/amount], language-thought disorder, content, disruptive-aggressive behaviors, appearance, and insight) based on subject’s report of his or her condition and clinician’s behavioral observations during the interview, with emphasis on the latter. Higher scores indicate worsening. The responses are summed to yield the YMRS total score, which ranges from 0 to 60.|Baseline to Week 6 LOCF End Point|Intent-to-Treat population with a baseline YMRS total score of >= 16.||points on scale||Standard Deviation|Mean
730697|NCT00397033|Other Pre-specified|Young Mania Rating Scale (YMRS) With Baseline YMRS Total Score >= 16|11-item scale (elevated mood, increased motor activity, sexual interest, sleep, irritability, speech [rate/amount], language-thought disorder, content, disruptive-aggressive behaviors, appearance, and insight) based on subject’s report of his or her condition and clinician’s behavioral observations during the interview, with emphasis on the latter. Higher scores indicate worsening. The responses are summed to yield the YMRS total score, which ranges from 0 to 60.|Baseline|Intent-to-Treat population with a baseline YMRS total score of >= 16.||points on a scale||Standard Deviation|Mean
730698|NCT00397033|Secondary|Clinical Global Impression (CGI-C) - Change for Schizoaffective Disorder|The CGI-C rating scale is a 7 point global assessment that measures the clinician’s impression of the change occurring in the illness over a course of treatment, relative to baseline. A rating of 4 is equivalent to “No change”. Ratings of <4 are equivalent to “improvement” and ratings of > 4 are equivalent to “worsening”.|Week 6 LOCF End Point|Intent-to-Treat population. One patient was not evaluable in the Paliperidone ER Low Dose treatment group.||points on a scale||Standard Deviation|Mean
730699|NCT00397033|Primary|The Change From Baseline to Week 6 or the Last Post-randomization Assessment During Double-blind Treatment in the Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score.|The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.|Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point|Intent-to-Treat population||points on scale||Standard Deviation|Mean
731038|NCT00401258|Secondary|Short Form McGill Pain Questionnaire||At each visit||||||
731039|NCT00401258|Secondary|Brief Pain Inventory||At each visit||||||
730700|NCT00397033|Secondary|Change in Clinical Global Impression (CGI-S) - Severity for Schizoaffective Disorder|The CGI-S rating scale is a 7 point global assessment that measures the clinician’s impression of the severity of illness exhibited by a subject. A rating of 1 is equivalent to “Normal, not at all ill” and a rating of 7 is equivalent to “Among the most extremely ill subjects”.|Baseline to Week 6 LOCF End Point|Intent-to-Treat population. One patient was not evaluable in the Paliperidone ER Low Dose treatment group.||points on scale||Standard Deviation|Mean
730701|NCT00397033|Secondary|Clinical Global Impression (CGI-S) - Severity for Schizoaffective Disorder Score at Baseline|The CGI-S rating scale is a 7 point global assessment that measures the clinician’s impression of the severity of illness exhibited by a subject. A rating of 1 is equivalent to “Normal, not at all ill” and a rating of 7 is equivalent to “Among the most extremely ill subjects”.|Baseline|Intent-to-Treat population.||points on a scale||Standard Deviation|Mean
730702|NCT00397033|Secondary|Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Anxiety/Depression Factor Score|Anxiety/Depression PANSS Factor Score (range 4-28): Sum of scores for items 2, 3, 4, and 6 in general psychopathology subscale: Anxiety, Guilt feelings, Tension, Depression. Higher scores indicate worsening.|Baseline to Week 6 LOCF End Point|Intent-to-Treat population||points on a subscale||Standard Deviation|Mean
730703|NCT00397033|Secondary|Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Uncontrolled Hostility/Excitement Factor Score|Uncontrolled Hostility/Excitement PANSS Factor Score (range 4-28): Sum of scores for items 4 and 7 in positive subscale: excitement, hostility; and items 8 and 14 in general psychopathology subscale: uncooperativeness, and poor impulse control. Higher scores indicate worsening.|Baseline to Week 6 LOCF End Point|Intent-to-Treat population||points on a subscale||Standard Deviation|Mean
730704|NCT00397033|Secondary|Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Disorganized Thought Factor Score|Disorganized Thoughts PANSS Factor Score (range 7-49): Sum of scores for item 2 in positive subscale:Conceptual disorganization; item 5 in negative subscale:difficulty in abstract thinking; and items 5, 10, 11, 13, and 15 in general psychopathology subscale: mannerisms/posturing, disorientation, poor attention, disturbance of volition, and preoccupation. Higher scores indicate worsening.|Baseline to Week 6 LOCF End Point|Intent-to-Treat population||points on a subscale||Standard Deviation|Mean
730705|NCT00397033|Secondary|Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Negative Factor Score|Negative PANSS Factor Score (range 7-49): Sum of scores for items 1, 2, 3, 4, and 6 in negative subscale: blunted affect, emotional withdrawal, poor rapport, passive social withdrawal, lack of spontaneity; and items 7 and 16 in general psychopathology subscale: motor retardation, and active social avoidance. Higher scores indicate worsening.|Baseline to Week 6 LOCF End Point|Intent-to-Treat population||points on a subscale||Standard Deviation|Mean
730706|NCT00397033|Other Pre-specified|Change in Hamilton Rating Scale for Depression (HAM-D-21) With Baseline HAM-D-21 Total Score >= 16|Clinician-rated scale that evaluates depressed mood as well as the vegetative and cognitive symptoms of depression. The items are rated on either a 5-point (0 to 4) or a 3-point (0 to 2) scale. The 5-point scale uses a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). Higher scores indicate worsening. The responses are summed to yield the HAM-D-21 score that ranges from 0-63.|Baseline to Week 6 LOCF End Point|Intent-to-Treat population with a baseline HAM-D-21 total score of >= 16.||points on scale||Standard Deviation|Mean
730707|NCT00397033|Other Pre-specified|Hamilton Rating Scale for Depression (HAM-D-21) With Baseline HAM-D-21 Total Score >= 16|Clinician-rated scale that evaluates depressed mood as well as the vegetative and cognitive symptoms of depression. The items are rated on either a 5-point (0 to 4) or a 3-point (0 to 2) scale. The 5-point scale uses a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). Higher scores indicate worsening. The responses are summed to yield the HAM-D-21 score that ranges from 0-63.|Baseline|Intent-to-Treat population with a baseline HAM-D-21 total score of >= 16.||points on a scale||Standard Deviation|Mean
730708|NCT00397033|Secondary|Positive and Negative Symptoms of Schizophrenia (PANSS) Positive Factor Score|Positive PANSS Factor Score (range 8-56): Sum of scores for items 1, 3, 5, and 6 in positive subscale: delusions, hallucinatory behavior, grandiosity, suspiciousness; item 7 in negative subscale: stereotyped thinking; and items 1, 9, and 12 in general psychopathology subscale: somatic concern, unusual thought content, lack of judgment, and insight. Higher scores indicate worsening.|Baseline to Week 6 LOCF End Point|Intent-to-Treat population.||points on a subscale||Standard Deviation|Mean
730709|NCT00397033|Secondary|Change in Positive and Negative Symptoms of Schizophrenia (PANSS) General Psychopathology Subscale Score|General Psychopathology (range 16-112): Sum of scores for somatic concern, anxiety, guilt feelings, tension, mannerisms/posturing, depression, motor retardation, uncooperativeness, unusual thought content, disoriented, poor attention, lack of judgment/insight, disturbance of volition, poor impulse control, preoccupation, and active social avoidance. Higher scores indicate worsening.|Baseline to Week 6 LOCF End Point|Intent-to-Treat population||points on a subscale||Standard Deviation|Mean
730710|NCT00397033|Secondary|Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Negative Subscale Score|Negative Syndrome Scale (range 7-49): Sum of scores for items 1-7 in negative subscale: blunted effect, emotional withdrawal, poor rapport, passive apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Higher scores indicate worsening.|Baseline to Week 6 LOCF End Point|Intent-to-Treat population||points on a subscale||Standard Deviation|Mean
730711|NCT00397033|Secondary|Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Positive Subscale Score|Positive Syndrome Scale (range 7-49): Sum of scores for items 1-7 in positive subscale: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. Higher scores indicate worsening.|Baseline to Week 6 LOCF End Point|Intent-to-Treat population.||points on subscale||Standard Deviation|Mean
730712|NCT00397033|Secondary|Number of Participants With Response|Response is defined as a 30% or more reduction from baseline in PANSS total score and a CGI-C score of <= 2. (CGI-C-SCA: Clinical Global Impression of Change for Schizoaffective Disorder). The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a subject.|Baseline to Week 6 LOCF End Point|Intent-to-Treat population. One patient was not evaluable in the Paliperidone ER Low Dose treatment group.||count of participants|||Number
730713|NCT00397033|Primary|Baseline Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score|The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.|Baseline|The Intent-to-Treat population included all randomized participants who received at least 1 dose of study medication (or any portion of a dose) and had both baseline and at least 1 postbaseline PANSS assessment.||points on a scale||Standard Deviation|Mean
730714|NCT00397150|Primary|Exclusive Breastfeeding Rates in South Africa|The EBF prevalences based on 24-h recall at 12 weeks in the intervention and control clusters.|at 3 months of age|ITT||participants|||Number
730715|NCT00397150|Primary|Exclusive Breastfeeding Rates in Uganda|The EBF prevalences (24-h recall) at 12 weeks in the intervention and control clusters.|at 3 months of age|ITT||participants|||Number
730716|NCT00397150|Secondary|Per Protocol Analysis of Infant Morbidity||at 3 months of age||||||
730717|NCT00397150|Secondary|Per Protocol Analysis of EBF Rates||at 3 months of age||||||
730718|NCT00397150|Secondary|Growth||(up to 6 months of age)||||||
730719|NCT00397150|Primary|Infant Morbidity, 2 Week Diarrhoea Prevalence||at 3 months of age|||participants|||Number
730720|NCT00397150|Primary|Exclusive Breastfeeding Rates in Burkina Faso|The EBF prevalences (24-h recall) at 12 weeks in the intervention and control clusters.|at 3 months of age|ITT||participants|||Number
730721|NCT00397189|Secondary|The Change From Baseline in Subjective Sleep Maintenance.||3 weeks||||||
730722|NCT00397189|Primary|The Change From Baseline in Subjective Sleep Latency.|Sleep latency (SL) after 3 weeks of treatment was assessed by Patient Daily Sleep Diary. The patients reported subjectively of their SL. The Sleep Diary question 3 (SL) was summarised at baseline (end of the two-week run-in period) and after three weeks double-blind treatment (actual and change from baseline) for each treatment group using descriptive statistics. At each visit, the mean of the seven days prior to the visit were used. For each treatment group, the mean score at visit 3 was compared, adjusting for the visit 2 score. An ANCOVA model was used.|Baseline and 3 weeks|Pre-planned analysis on ITT population age 65-80||minutes||Standard Deviation|Mean
730723|NCT00397215|Primary|Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:28. This outcome only covers results from the adjuvanted groups.|At Day 180|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.||Titer||95% Confidence Interval|Geometric Mean
730724|NCT00397215|Primary|Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:28. This outcome only covers results from the adjuvanted groups.|At Month 24|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.||Titer||95% Confidence Interval|Geometric Mean
730725|NCT00397215|Primary|Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:28. This outcome only covers results from the adjuvanted groups.|At Month 12|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.||Titer||95% Confidence Interval|Geometric Mean
730726|NCT00397215|Primary|Number of Seroconverted Subjects for Neutralizing Antibody Response Against 2 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). This outcome only covers results from the adjuvanted groups.|At Month 24|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.||Subjects|||Number
730727|NCT00397215|Primary|Number of Seroconverted Subjects for Neutralizing Antibody Response Against 2 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). This outcome only covers results from the adjuvanted groups.|At Month 12|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.||Subjects|||Number
730738|NCT00397215|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.|At Month 24|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.||Titer||95% Confidence Interval|Geometric Mean
730728|NCT00397215|Primary|Number of Seroconverted Subjects for Neutralizing Antibody Response Against 2 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). This outcome only covers results from the adjuvanted groups.|At Day 180|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.||Subjects|||Number
730729|NCT00397215|Primary|Number of Seroprotected Subjects Against 2 Strains of Influenza Disease|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).|At Month 24|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.||Subjects|||Number
730730|NCT00397215|Primary|Number of Seroprotected Subjects Against 2 Strains of Influenza Disease|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).|At Month 12|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.||Subjects|||Number
730731|NCT00397215|Primary|Number of Seroprotected Subjects Against 2 Strains of Influenza Disease|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).|At Day 180|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.||Subjects|||Number
730732|NCT00397215|Primary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).|At Month 24|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.||Fold||95% Confidence Interval|Geometric Mean
730733|NCT00397215|Primary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).|At Month 12|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.||Fold||95% Confidence Interval|Geometric Mean
730734|NCT00397215|Primary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease.|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).|At Day 180|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.||Fold||95% Confidence Interval|Geometric Mean
730735|NCT00397215|Primary|Number of Seroconverted Subjects Against 2 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).|At Month 24|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.||Subjects|||Number
730736|NCT00397215|Primary|Number of Seroconverted Subjects Against 2 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).|At Month 12|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.||Subjects|||Number
730737|NCT00397215|Primary|Number of Seroconverted Subjects Against 2 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).|At Day 180|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.||Subjects|||Number
730739|NCT00397215|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.|At Month 12|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.||Titer||95% Confidence Interval|Geometric Mean
730740|NCT00397215|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.|At Day 180|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.||Titers||95% Confidence Interval|Geometric Mean
730741|NCT00397215|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.|Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, myalgia, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day follow-up period (Days 0 to 6) after any vaccination|The analysis was based on the Total Vaccinated Cohort, which included all subjects with at least one documented dose, for whom data were available.||Subjects|||Number
730742|NCT00397215|Secondary|Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells|The geometric mean was calculated for cluster of differentiation (CD) 4/CD 8 T-cells (per million) producing at least one cytokine beside either of the following: CD40 ligand [CD40L], interleukin-2 [IL-2], tumor necrosis factor-alpha [TNF-α] or interferon-gamma [IFN-γ].|At Day 180|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.||Cells||Standard Deviation|Geometric Mean
730743|NCT00397215|Secondary|Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells.|The geometric mean was calculated for cluster of differentiation (CD) 4/CD 8 T-cells (per million) producing at least one cytokine beside either of the following: CD40 ligand [CD40L], interleukin-2 [IL-2], interferon gamma [INF-g] and tumor necrosis factor-alpha [TNF-α].|At Days 0, 21 and 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||Cells||Standard Deviation|Geometric Mean
730744|NCT00397215|Secondary|Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters.|Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (HEM), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Per parameter and range, it was assessed whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents NEU, PLA, RBC, URE and WBC results.|At Days 0, 2, 21 and 23.|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.||Subjects|||Number
730745|NCT00397215|Secondary|Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells.|The geometric mean was calculated for cluster of differentiation (CD) 4/CD 8 T-cells (per million) producing at least one cytokine beside either of the following: CD40 ligand [CD40L], interleukin-2 [IL-2], tumor necrosis factor-alpha [TNF-α] or interferon-gamma [IFN-γ].|At Month 24|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available||Cells||Standard Deviation|Geometric Mean
730746|NCT00397215|Secondary|Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells.|The geometric mean was calculated for cluster of differentiation (CD) 4/CD 8 T-cells (per million) producing at least one cytokine beside either of the following: CD40 ligand [CD40L], interleukin-2 [IL-2], tumor necrosis factor-alpha [TNF-α] or interferon-gamma [IFN-γ].|At Month 12|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.||Cells||Standard Deviation|Geometric Mean
730747|NCT00397215|Secondary|Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters.|Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS), creatinine phosphokinase (CRPH), creatinine (CREA), eosinophils (EOS), haemoglobin (HEM), lactate dehydrogenase (LDE), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), urea (URE) and white blood cells (WBC). Per parameter and range, it was assessed whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents EOS, HEM, LDE, LYM and MON results.|At Days 0, 2, 21 and 23.|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.||Subjects|||Number
730758|NCT00397215|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.|At Days 0, 21 and 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||Titer||95% Confidence Interval|Geometric Mean
730748|NCT00397215|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 21-day (Days 0-20) follow-up period after first vaccination and during the 30-day (Days 0-29) follow-up period after second vaccination|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.||Subjects|||Number
730749|NCT00397215|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|"Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Note: The study period was divided into 4 consecutive periods (Days 0-51, Days 52-180 [Month 6], Months 6-12 and Months 12-24), for which SAEs were collected."|During the entire study period (Day 0 to Month 24).|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.||Subjects|||Number
730750|NCT00397215|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms.|Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 ecchymosis/induration/redness/swelling = ecchymosis/induration/redness/swelling spreading beyond 100 millimeters (mm) of injection site.|During the 7-day follow-up period (Days 0 to 6) after any vaccination|The analysis was based on the Total Vaccinated Cohort, which included all subjects with at least one documented dose, for whom data were available.||Subjects|||Number
730751|NCT00397215|Secondary|Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters.|Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS), creatinine phosphokinase (CRPH), creatinine (CREA), eosinophils (EOS), haemoglobin (HEM), lactate dehydrogenase (LDE), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), urea (URE) and white blood cells (WBC). Per parameter and range, it was assessed whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for ALT, AST, BAS, CREA and CRPH.|At Days 0, 2, 21 and 23|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Subjects|||Number
730752|NCT00397215|Secondary|Number of Subjects With Adverse Events of Specific Interest (AESIs)|"An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.
Note: No AESIs were reported during the entire study period."|During the entire study period (Day 0 to Month 24)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available, on a subset of subjects enrolled for this study in Belgium.|||||
730753|NCT00397215|Primary|Number of Seroconverted Subjects for Neutralizing Antibody Response Against 2 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). This outcome only covers results from the adjuvanted groups.|At Day 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||Subjects|||Number
730754|NCT00397215|Primary|Number of Seroconverted Subjects Against 2 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).|At Days 21 and 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||Subjects|||Number
730755|NCT00397215|Primary|Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:28. This outcome only covers results from the adjuvanted groups.|At Days 0 and 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||Titer||95% Confidence Interval|Geometric Mean
730756|NCT00397215|Primary|Number of Seroprotected Subjects Against 2 Strains of Influenza Disease|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).|At Days 0, 21 and 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||Subjects|||Number
730757|NCT00397215|Primary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease.|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).|At Days 21 and 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||Fold||95% Confidence Interval|Geometric Mean
730759|NCT00397254|Secondary|Adverse Experiences|Participants with one or more Adverse Experiences (AEs) in Formulary Limit Group versus Clinical Limit Group collected from time patient provided informed consent until return at Visit 7 or through 14 days post-dosing of the last dose of study medication if serious adverse experience. Defined as any unfavorable and unintended change in structure, function, or chemistry of the body temporally associated with use of provided product whether or not considered related to use of the product. Includes any worsening of a preexisting condition temporally associated with use of provided product.|6 months|197 enrolled in Baseline(BL). Analysis of BL Characteristics on 197. 42 discontinued (2 Adverse Event(AE),10 Lost to followup(LFU),11 Withdrew consent,1 Pregnant,16 Failed randomization criteria,2 Other). 155 randomized. 4/155 LFU. 151 in analysis(77 Clinical Limit/74 Formulary Limit). 143 completed all visits(74 Clinical Limit/69 Formulary Limit).||Participants|||Number
730760|NCT00397254|Secondary|Percentage of Attacks With Return to Normal Ability to Perform Activities at 2 Hours Post-dose|Percentage of attacks with mild, moderate or severely impaired ability to perform activities pre-treatment with return to normal function at 2 hours post-dose in Formulary Limit Group versus Clinical Limit Group|6 months|197 enrolled in Baseline(BL). Analysis of BL Characteristics on 197. 42 discontinued (2 Adverse Event(AE),10 Lost to followup(LFU),11 Withdrew consent,1 Pregnant,16 Failed randomization criteria,2 Other). 155 randomized. 4/155 LFU. 151 in analysis(77 Clinical Limit/74 Formulary Limit). 143 completed all visits(74 Clinical Limit/69 Formulary Limit).||Percentage of attacks|||Number
730761|NCT00397254|Secondary|Percentage of Attacks With Symptom Elimination at 2 Hours|Percentage of attacks with elimination of all associated symptoms at 2 hours post-treatment in Formulary Limit Group versus percentage of attacks with elimination of all associated symptoms at 2 hours post-treatment in Clinical Limit Group|6 months|197 enrolled in Baseline(BL). Analysis of BL Characteristics on 197. 42 discontinued (2 Adverse Event(AE),10 Lost to followup(LFU),11 Withdrew consent,1 Pregnant,16 Failed randomization criteria,2 Other). 155 randomized. 4/155 LFU. 151 in analysis(77 Clinical Limit/74 Formulary Limit). 143 completed all visits(74 Clinical Limit/69 Formulary Limit).||Percentage of attacks|||Number
730762|NCT00397254|Secondary|Headache Severity of All Attacks|4-Point Headache Severity Scale (0 = No Pain / 1 = Mild Pain / 2 = Moderate Pain / 3 = Severe Pain)|6 months|197 enrolled in Baseline(BL). Analysis of BL Characteristics on 197. 42 discontinued (2 Adverse Event(AE),10 Lost to followup(LFU),11 Withdrew consent,1 Pregnant,16 Failed randomization criteria,2 Other). 155 randomized. 4/155 LFU. 151 in analysis(77 Clinical Limit/74 Formulary Limit). 143 completed all visits(74 Clinical Limit/69 Formulary Limit).||Units on a scale||Full Range|Median
730763|NCT00397254|Secondary|Average Attack Duration||6 months|197 enrolled in Baseline(BL). Analysis of BL Characteristics on 197. 42 discontinued (2 Adverse Event(AE),10 Lost to followup(LFU),11 Withdrew consent,1 Pregnant,16 Failed randomization criteria,2 Other). 155 randomized. 4/155 LFU. 151 in analysis(77 Clinical Limit/74 Formulary Limit). 143 completed all visits(74 Clinical Limit/69 Formulary Limit).||Hours||Standard Deviation|Mean
730764|NCT00397254|Secondary|Percentage of Responders|Percentage of Responders (50% decrease in attack frequency) of Formulary Limit Group versus Percentage of Responders (50% decrease in attack frequency) in Clinical Limit Group|6 months|197 enrolled in Baseline(BL). Analysis of BL Characteristics on 197. 42 discontinued (2 Adverse Event(AE),10 Lost to followup(LFU),11 Withdrew consent,1 Pregnant,16 Failed randomization criteria,2 Other). 155 randomized. 4/155 LFU. 151 in analysis(77 Clinical Limit/74 Formulary Limit). 143 completed all visits(74 Clinical Limit/69 Formulary Limit).||Percentage of Participants|||Number
730765|NCT00397254|Secondary|Number of Migraine Attacks||6 months|197 enrolled in Baseline(BL). Analysis of BL Characteristics on 197. 42 discontinued (2 Adverse Event(AE),10 Lost to followup(LFU),11 Withdrew consent,1 Pregnant,16 Failed randomization criteria,2 Other). 155 randomized. 4/155 LFU. 151 in analysis(77 Clinical Limit/74 Formulary Limit). 143 completed all visits(74 Clinical Limit/69 Formulary Limit).||Migraine attacks||Standard Deviation|Mean
730766|NCT00397254|Primary|Number of Days With Migraine||6 months|197 enrolled in Baseline(BL). Analysis of BL Characteristics on 197. 42 discontinued (2 Adverse Event(AE),10 Lost to followup(LFU),11 Withdrew consent,1 Pregnant,16 Failed randomization criteria,2 Other). 155 randomized. 4/155 LFU. 151 in analysis(77 Clinical Limit/74 Formulary Limit). 143 completed all visits(74 Clinical Limit/69 Formulary Limit).||Days||Standard Deviation|Mean
730767|NCT00397462|Secondary|Proximal Tibia Bone Density|Proximal tibia bone mineral density by dual energy x-ray absorptiometry (DXA)|One year|||percent change in bone density||Standard Error|Mean
730768|NCT00397462|Primary|Bone Density of Proximal Femur|Proximal femur bone mineral density by dual energy x-ray absorptiometry (DXA)|One year|||percent change in bone density||Standard Error|Mean
730769|NCT00397488|Primary|Overall Objective Response|Response rate as measured by RECIST criteria. The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started). In general, the patient's best response assignment will depend on the achievement of both measurement and confirmation criteria|2 years|||participants|||Number
730770|NCT00397514|Secondary|Cardio-pulmonary Bypass Time||Baseline and after 20 minutes|||min.||Full Range|Median
730771|NCT00397514|Secondary|QRS Duration||Baseline and after 20 minutes of pacing|||ms||Full Range|Median
730772|NCT00397514|Secondary|Ventilatory Support||Unspecified||||||
730773|NCT00397514|Secondary|Inotropic Support||Unspecified||||||
730774|NCT00397514|Secondary|TDI Indices (Tissue Velocities, Tissue Tracking, Regional Strain, and Regional Strain Rates)||Unspecified||||||
730775|NCT00397514|Secondary|Incidence of Low Output Syndrome||Unspecified||||||
730776|NCT00397514|Secondary|Systolic Blood Pressure||Unspecified||||||
730777|NCT00397514|Primary|Cardiac Index||Baseline and after 20 minutes of pacing|||L/min/m2||Full Range|Median
730778|NCT00397540|Secondary|1,3,5-year Overall Survival||1,3,5-year||05/2018||||
730779|NCT00397540|Primary|1,3,5 Year-Disease Free Survival (or Recurrence Free Survival)|The disease free survival is defined as the total number of surviving participants without intrahepatic recurrence of hepatocellular carcinoma for 1, 3, and 5 years.|1,3,5 year|ITT analysis||participants|||Number
730806|NCT00397891|Primary|Number of Participants With Clinically Significant Changes in Neurological Examinations|Neurological examination included the assessment of mental status, cranial nerves, visual fields, sensory, motor, gait, primitive reflexes and tendon reflexes.|Screening up to Week 52|Safety data set included all randomized participants who received at least 1 dose of study medication.||participants|||Number
730780|NCT00397631|Secondary|Change From Baseline in 2-hour PPG (Post-prandial Glucose) at Week 24|Change from baseline at Week 24 is defined as Week 24 minus Week 0.|Baseline and Week 24|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. For FAS patients with no data at Week 24, the last observed measurement was carried forward to Week 24.||mg/dL||95% Confidence Interval|Least Squares Mean
730781|NCT00397631|Secondary|Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24|Change from baseline at Week 24 is defined as Week 24 minus Week 0.|Baseline and Week 24|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. For FAS patients with no data at Week 24, the last observed measurement was carried forward to Week 24.||mg/dL||95% Confidence Interval|Least Squares Mean
730782|NCT00397631|Primary|Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24|HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent.|Baseline and 24 weeks|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. For FAS patients with no data at Week 24, the last observed measurement was carried forward to Week 24.||Percent||95% Confidence Interval|Least Squares Mean
730783|NCT00397839|Secondary|Responder Rate of Subjects Who Remained the Same or Had Any Improvement in BMD (>= Baseline) at 6 Months and 12 Months|Responders are defined as participants who have BMD values >= their baseline values at Months 6 and 12, and not any pre-defined percentage increase in BMD values of clinical significance.|12 months|Intent-to-treat population||participants|||Number
730784|NCT00397839|Secondary|Mean Percent Change in BMD of Proximal Femur Sites (Total Hip, Trochanter, Femoral Neck) From Baseline to Month 6|BMD will be assessed using an analysis of covariance model (ANCOVA) with datea obtained from dual-Energy X-ray absorptiometry scans.|6 months|Intent-to-treat population. Includes patients with measurements at Baseline and Month 6.||percent||Standard Error|Least Squares Mean
730785|NCT00397839|Secondary|Mean Percent Change in BMD of Proximal Femur Sites (Total Hip, Trochanter, Femoral Neck) From Baseline to Month 12|BMD will be assessed using an analysis of covariance model (ANCOVA) with datea obtained from dual-Energy X-ray absorptiometry scans.|12 months|Intent-to-treat population. Includes patients with measurements at Baseline and Month 12.||percent||Standard Error|Least Squares Mean
730786|NCT00397839|Secondary|Mean Percent Change in BMD of the Lumbar Spine From Baseline to Month 6|BMD will be assessed using an analysis of covariance model (ANCOVA) with datea obtained from dual-Energy X-ray absorptiometry scans.|6 months|Intent-to-treat population. Includes patients with measurements at Baseline and Month 6.||percent||Standard Error|Least Squares Mean
730787|NCT00397839|Primary|Mean Percent Change in BMD of the Lumbar Spine From Baseline to Month 12|BMD will be assessed using an analysis of covariance model (ANCOVA) with datea obtained from dual-Energy X-ray absorptiometry scans.|12 months|Intent-to-treat population. Includes participants with measurements at Baseline and Month 12.||percent||Standard Error|Least Squares Mean
730788|NCT00397878|Secondary|Pre- and Post-treatment Expression Values for Each Biological Correlate|Statistical significance of the associations assessed using a nonparametric Sign Test performed on the difference of the post-treatment and pre-treatment values. A two-sided .05 significance level to be used.|Up to 2 weeks||||||
730789|NCT00397878|Secondary|Time to Progression|Length of time from the start of treatment until disease progression using Kaplan-Meier estimates.|Up to 5 years||||||
730790|NCT00397878|Secondary|Overall Survival|Length of time from start of treatment that participants are still alive using Kaplan-Meier estimates.|Up to 5 years||||||
730791|NCT00397878|Primary|Median Progression Free Survival (PFS)|Proportion of metastatic colorectal patients with one previous chemotherapy treatment for metastatic disease who are alive and progression free after commencing the experimental therapy. A 95% posterior credible intervals used.|Time from start of treatment to time of progression, up to 4 months|||weeks||Full Range|Median
730792|NCT00397891|Secondary|Plasma Amyloid-beta (x-40) Concentrations|Amyloid-beta (A-beta) is a peptide fragment of the amyloid precursor protein which is one of the characteristic hallmarks of Alzheimer's disease (AD). Total plasma amyloid-beta (x-40) was determined using a validated ELISA method.|0 (pre-infusion), 1, 6, 24, 336, 1008, 2184, 2688, 4368, 8736 hours post start of infusion|PK data set included all randomized participants who had at least 1 available data of serum bapineuzumab, serum anti-bapineuzumab antibody or plasma amyloid beta concentration. Here ‘n’ signifies those participants who were evaluable for this measure at the specified time point for each arm, respectively.||picogram per milliliter (pg/mL)||Standard Deviation|Mean
730793|NCT00397891|Secondary|Number of Participants With Positive Serum Anti-Bapineuzumab Antibody|Serum anti-bapineuzumab antibody concentration was determined by using a validated ELISA method.|Baseline (Day 1) up to Week 52|PK data set included all randomized participants who had at least 1 available data of serum bapineuzumab, serum anti-bapineuzumab antibody or plasma amyloid beta concentration.||participants|||Number
730794|NCT00397891|Secondary|Serum Bapineuzumab Concentrations|Serum bapineuzumab concentration was determined by using a validated enzyme-linked immunosorbent assay (ELISA) method. Participants who received bapineuzumab were reported.|0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6, 24, 48, 168, 336, 672, 1008, 1344, 1848, 2184, 2688, 4368, 8736 hours post start of infusion|PK data set included all randomized participants who had at least 1 available data of serum bapineuzumab, serum anti-bapineuzumab antibody or plasma amyloid beta concentration. Here ‘n’ signifies those participants who were evaluable for this measure at the specified time point for each arm, respectively.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
730795|NCT00397891|Secondary|Serum Decay Half-Life (t1/2) of Bapineuzumab|Serum decay half-life is the time measured for the serum concentration to decrease by one half. Participants who received bapineuzumab were reported.|0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6 hours post start of infusion on Day 1; Day 2, 3; Week 1, 2, 4, 6, 8, 11, 13, 16, 26, 52|PK data set included all randomized participants who had at least 1 available data of serum bapineuzumab, serum anti-bapineuzumab antibody or plasma amyloid beta concentration.||days||Standard Deviation|Mean
730846|NCT00398216|Secondary|Adjudicated Incidence of Major or Clinically Relevant Non-major Bleeding Events|adjudicated incidence of major or clinically relevant non-major bleeding events through 10 days after first dose|10 days after first dose|safety analysis dataset||percentage of subjects with bleed events||95% Confidence Interval|Number
731072|NCT00401622|Secondary|To Assess the Change in Daily Glycemic Excursions Between the OneTouch® Ultra®2 and Control BGMS.||52 wks|||mg/dL||Standard Deviation|Mean
730796|NCT00397891|Secondary|Mean Residence Time of Bapineuzumab|MRT is average time for which the drug molecules resides in the body, after administration. It is calculated as area under the serum concentration versus time first moment curve from time zero (pre-dose) to extrapolated infinite time (AUMC [0 - ∞]) divided by area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (AUC[0 - ∞]). AUMC (0-∞) is calculated as AUMC(0-inf)= AUMCt + [(t x Ct) / kel] + (Ct / kel^2). AUMCt is the area under the first moment curve from zero time to time t calculated using the trapezoidal method, Ct is the concentration at time t and kel is the terminal phase rate constant. Participants who received bapineuzumab were reported.|0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6 hours post start of infusion on Day 1; Day 2, 3; Week 1, 2, 4, 6, 8, 11, 13, 16, 26, 52|PK data set included all randomized participants who had at least 1 available data of serum bapineuzumab, serum anti-bapineuzumab antibody or plasma amyloid beta concentration.||days||Standard Deviation|Mean
730797|NCT00397891|Secondary|Volume of Distribution at Steady State (Vss) of Bapineuzumab|Volume of distribution is defined as the theoretical blood volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state. Participants who received bapineuzumab were reported.|0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6 hours post start of infusion on Day 1; Day 2, 3; Week 1, 2, 4, 6, 8, 11, 13, 16, 26, 52|PK data set included all randomized participants who had at least 1 available data of serum bapineuzumab, serum anti-bapineuzumab antibody or plasma amyloid beta concentration.||mL||Standard Deviation|Mean
730798|NCT00397891|Secondary|Systemic Clearance (CL) of Bapineuzumab|CL is a quantitative measure of the rate at which a drug substance is removed from the body. Participants who received bapineuzumab were reported.|0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6 hours post start of infusion on Day 1; Day 2, 3; Week 1, 2, 4, 6, 8, 11, 13, 16, 26, 52|PK data set included all randomized participants who had at least 1 available data of serum bapineuzumab, serum anti-bapineuzumab antibody or plasma amyloid beta concentration.||mL/hour||Standard Deviation|Mean
730799|NCT00397891|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Bapineuzumab|AUC is a measure of the serum concentration of the drug over time. AUC (0 - ∞) is area under the serum concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). Participants who received bapineuzumab were reported.|0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6 hours post start of infusion on Day 1; Day 2, 3; Week 1, 2, 4, 6, 8, 11, 13, 16, 26, 52|PK data set included all randomized participants who had at least 1 available data of serum bapineuzumab, serum anti-bapineuzumab antibody or plasma amyloid beta concentration.||mcg*hour/mL||Standard Deviation|Mean
730800|NCT00397891|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of Bapineuzumab|AUC is a measure of the serum concentration of the drug over time. AUC (0-t) is area under the serum concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t). Participants who received bapineuzumab were reported.|0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6 hours post start of infusion on Day 1; Day 2, 3; Week 1, 2, 4, 6, 8, 11, 13, 16, 26, 52|PK data set included all randomized participants who had at least 1 available data of serum bapineuzumab, serum anti-bapineuzumab antibody or plasma amyloid beta concentration.||mcg*hour/mL||Standard Deviation|Mean
730801|NCT00397891|Secondary|Time to Reach Maximum Observed Serum Concentration (Tmax) of Bapineuzumab|Participants who received bapineuzumab were reported.|0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6 hours post start of infusion on Day 1; Day 2, 3; Week 1, 2, 4, 6, 8, 11, 13, 16, 26, 52|PK data set included all randomized participants who had at least 1 available data of serum bapineuzumab, serum anti-bapineuzumab antibody or plasma amyloid beta concentration.||hours||Full Range|Median
730802|NCT00397891|Secondary|Maximum Observed Serum Concentration (Cmax) of Bapineuzumab|Participants who received bapineuzumab were reported.|0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6 hours post start of infusion on Day 1; Day 2, 3; Week 1, 2, 4, 6, 8, 11, 13, 16, 26, 52|Pharmacokinetic (PK) data set included all randomized participants who had at least 1 available data of serum bapineuzumab, serum anti-bapineuzumab antibody or plasma amyloid beta concentration.||microgram per milliliter (mcg/mL)||Standard Deviation|Mean
730803|NCT00397891|Primary|Change From Baseline in Mini-Mental State Examination (MMSE) Score at Week 52|MMSE measures general cognitive functioning: orientation to time (range: 0 to 5) and orientation to place (range: 0 to 5), registration of 3 words (range: 0 to 3), attention and calculation (range: 0 to 5), recall of 3 words (range: 0 to 3), naming (range: 0 to 2), repetition (range: 0 to 1), comprehension (range: 0 to 3), reading (range: 0 to 1), writing (range: 0 to 1) and drawing (range: 0 to 1). Total score is the sum of sub-scores; total score ranges from 0 to 30, higher score indicates better cognitive state.|Baseline, Week 52|Safety data set included all randomized participants who received at least 1 dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
730804|NCT00397891|Primary|Change From Baseline in Mini-Mental State Examination (MMSE) Score at Week 16|MMSE measures general cognitive functioning: orientation to time (range: 0 to 5) and orientation to place (range: 0 to 5), registration of 3 words (range: 0 to 3), attention and calculation (range: 0 to 5), recall of 3 words (range: 0 to 3), naming (range: 0 to 2), repetition (range: 0 to 1), comprehension (range: 0 to 3), reading (range: 0 to 1), writing (range: 0 to 1) and drawing (range: 0 to 1). Total score is the sum of sub-scores; total score ranges from 0 to 30, higher score indicates better cognitive state.|Baseline, Week 16|Safety data set included all randomized participants who received at least 1 dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
730805|NCT00397891|Primary|Change From Baseline in Mini-Mental State Examination (MMSE) Score at Week 6|MMSE measures general cognitive functioning: orientation to time (range: 0 to 5) and orientation to place (range: 0 to 5), registration of 3 words (range: 0 to 3), attention and calculation (range: 0 to 5), recall of 3 words (range: 0 to 3), naming (range: 0 to 2), repetition (range: 0 to 1), comprehension (range: 0 to 3), reading (range: 0 to 1), writing (range: 0 to 1) and drawing (range: 0 to 1). Total score is the sum of sub-scores; total score ranges from 0 to 30, higher score indicates better cognitive state.|Baseline, Week 6|Safety data set included all randomized participants who received at least 1 dose of study medication.||units on a scale||Standard Deviation|Mean
730807|NCT00397891|Primary|Number of Participants With Laboratory Test Results of Potential Clinical Importance|Criteria for PCI laboratory results: hematology (hematocrit [decrease >=5%], hemoglobin [decrease >=20gram/liter {g/L}] from baseline, white blood cells [<3], neutrophils [<1.5], platelet [<100], eosinophils [>0.5] *10^9/L); blood chemistry (sodium [>5], potassium [>0.5], fasting glucose [>0.83], phosphorous [>0.162] millimole/L [mmol/L] above upper limit of normal [ULN] and below lower limit of normal [LLN], non-fasting glucose >5 mmol/L above ULN, >0.56 mmol/L below LLN, creatinine >1.36*ULN, blood urea nitrogen >1.5*ULN, calcium [change of >=0.25 mmol/L], total protein [change of >=20g/L], albumin [change of >=10g/L], uric acid [change of >0.119mmol/L] from baseline and outside normal limits); Liver function tests (alanine aminotransferase/serum glutamic pyruvic transaminase [ALT/SGPT] and aspartate aminotransferase/serum glutamic oxaloacetic transaminase [AST/SGOT] >2*ULN, total bilirubin >2*ULN, alkaline phosphatase >1.5*ULN, gamma-glutamyl-transpeptidase [GGT] >3*ULN).|Week 1 up to Week 52|Safety data set included all randomized participants who received at least 1 dose of study medication.||participants|||Number
730808|NCT00397891|Primary|Number of Participants With Electrocardiogram (ECG) Results of Potential Clinical Importance|Criteria for determining PCI ECG result was described as: heart rate (>=120 bpm or <=45 bpm and increase or decrease of >15 bpm compared to baseline value), PR interval (>=220 millisecond (msec) and change of >=20 msec compared to baseline value), QRS interval (>=120 msec), corrected QT (QTc) interval for men (>450 msec), QTc interval for women (>470 msec).|Screening up to Week 16|Safety data set included all randomized participants who received at least 1 dose of study medication.||participants|||Number
730809|NCT00397891|Primary|Number of Participants With Vital Signs of Potential Clinical Importance|Criteria for determining potentially clinically important (PCI) vital signs was described as: supine blood pressure (BP)- systolic (greater than or equal to [>=]160 millimeter mercury [mm Hg] or less than or equal to [<=]90 mm Hg and increase or decrease of >=20 mm Hg compared to baseline value), supine diastolic BP (>=100 mm Hg or <= 50 mm Hg and increase or decrease of >=15 mm Hg compared to baseline value), supine pulse rate (>=120 beats per minute (bpm) or <=45 bpm and increase or decrease of >15 bpm compared to baseline value), body temperature (>38.3 degree Celsius and <35 degree Celsius).|Baseline up to Week 52|Safety data set included all randomized participants who received at least 1 dose of study medication.||participants|||Number
730810|NCT00397891|Primary|Number of Participants With Clinically Significant Changes in Physical Examinations|Physical examination included the assessment of abdomen, back/spinal, breasts, external genitalia, extremities, general appearance, head, eyes, ears, nose, throat (HEENT), heart, lungs, lymph nodes and skin.|Screening up to Week 52|Safety data set included all randomized participants who received at least 1 dose of study medication.||participants|||Number
730811|NCT00397891|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between dose of study medication and up to 52 weeks after the dose that were absent before treatment or that worsened relative to pre-treatment state.|Baseline up to Week 52|Safety data set included all randomized participants who received at least 1 dose of study medication.||participants|||Number
730812|NCT00397904|Primary|Complete and Partial Response Rate||2 years|||participants|||Number
730813|NCT00397930|Primary|Mean Post-Pre Change for the Pittsburgh Sleep Quality Inventory (PSQI)|"Pittsburgh Sleep Quality Index: Measures sleep disturbance and usual sleep habits during the prior month only using seven clinically derived domains of sleep difficulties: sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction. Global PSQI is a summary of the seven domains. Each Domain is scored from 0 to 3, therefore PSQI has a range of 0 (better) to 21 (worse). Interpretation of the PSQI is that a score less than 5 is associated with good sleep quality and a score of 5 or greater is associated with poor sleep quality.
PSQI was calculated at both pre- and post-intervention for both arms. Pre-intervention PSQI was recorded during the week immediately before commencing the 4-week intervention. Post-intervention PSQI was recorded during the week immediately following the intervention. Mean post-pre change was calculated for both arms."|2-24 months after surgery, chemotherapy, and/or radiation therapy|||units on a scale||Standard Error|Mean
730814|NCT00397982|Secondary|Progression-free Survival|Defined as the duration of time from start of treatment to time of progression, death or date of last follow-up.|Day 11 of courses 4, 8, 12, 16, 20, and 24, and then annually for up to 5 years|Entire study||months||Full Range|Median
730815|NCT00397982|Secondary|Comparison of Pre- vs Post-treatment Measurements of Biomarkers and Vascular System/Immune System Parameters|Biomarker expression in tumor and normal skin will be assessed by immunohistochemistry (IHC) or Western blotting, using marker-specific antibodies.|Day 1 of course 1 and day 8 of course 2|Detailed vascular changes were not assessed.|||||
730816|NCT00397982|Secondary|Comparison of Biomarkers to Antitumor Activity/Patient Outcomes|Assessed in both tumor tissue pretreatment. Mutations in BRAF were assessed in all 16 of the patients and were assessed for any association with clinical response|Day 1 of course 1 and day 8 of course 2|Patients evaluable for clinical outcome with BRAF mutation status.||Participants|||Count of Participants
730817|NCT00397982|Secondary|Association Between Expression or Activation of One Biomarker With Another, With Biochemical and Clinical Responses, With Alterations in Cell Proliferation and Apoptotic Markers, and With Time to Progression|Changes in the ratio of phospho-S6Kinase (pS6K) S240/244 to total S6, in the tumor, from day 1 to day 23. These were assessed by reverse-phase protein array. A linear model was fit with PROC MIXED in SAS 9.3 using the log base 10 of expression as the outcome measure. This measure type is not listed in the data table form; so the number of patients who had decreases in that ratio is listed.|Day 1 of course 1 and day 8 of course 2|This analysis was performed for those participants with sufficient tumor available for analysis.||participants who had decreases in ratio|||Number
730847|NCT00398216|Secondary|Change in Activated Partial Thromboplastin Time (aPTT) From Baseline|change in Activated Partial Thromboplastin Time (aPTT) from baseline to end of treatment end of treatment defined as 6-8 hours after hip replacement surgery to 7 to 10 days after the surgery|end of treatment|perp protocol analysis set||seconds||Standard Deviation|Mean
730818|NCT00397982|Secondary|Adverse Events in Participants With Stage III or IV Melanoma Treated With Temsirolimus and Bevacizumab|Defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome, or disease which either occurs during the study (having been absent at baseline) or if present at baseline, appears to worsen. Graded using scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Tabulated by type and severity: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.|On days 1 and 8 of each cycle, and up to 2 years after registration.|Treatment related adverse events.||participants|||Number
730819|NCT00397982|Primary|Objective Tumor Response (Complete Response and Partial Response) and Progression in Participants With Stage III or IV Melanoma Following Treatment With Temsirolimus and Bevacizumab|Evaluated using Response Evaluation Criteria In Solid Tumor (RECIST) criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (POD); POD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions.|Up to 18 weeks after registration.|||participants|||Number
730820|NCT00398047|Secondary|Expression of p53 and p21||Approximately 12 months|Because no patients completed therapy, no analysis was possible|||||
730821|NCT00398047|Secondary|Change in Bone Marrow Apoptosis||Baseline and approximately 12 months|Because no patients completed therapy, no analysis was done|||||
730822|NCT00398047|Secondary|Overall Survival||Approximately 12 months|Because no patients completed therapy, and the protocol was closed early, analysis was not performed|||||
730823|NCT00398047|Secondary|Time to Progression to Acute Myeloid Leukemia (Blast ≥ 20%) or Death|Death during treatment or disease progression characterized by worsening of cytopenias, increase in the percentage of the blasts, reduction of hemoglobin concentration by at least 2 g/dl or transfusion dependence in the absence of another explanation, such as acute infection, gastrointestinal bleeding, hemolysis.|Approximately 12 months|Because no patients completed therapy, no analysis was possible|||||
730824|NCT00398047|Secondary|Minor Hematological Improvements|For patients with pretreatment platelet count less than 100,000/mm3, a 50% or more increase in platelet count with a net increase greater than 10,000/mm3 but less than 30,000/mm3|Approximately 112 days|Because no patients completed therapy, no analysis was possible|||||
730825|NCT00398047|Primary|Rate of Major Hematological Improvement|For patients with pretreatment hemoglobin less than 11 g/dL, greater than 2 g/dL increase in hemoglobin; for red cell transfusion-dependent patients, transfusion independence.|Approximately 112 days|Because no patients completed therapy, no analysis was possible|||||
730826|NCT00398047|Primary|Number of Participants With Complete Response|Complete response is normalization of abnormal blood counts, and disappearance of signs of morphological changes in the bone marrow. If the previously present cytogenetic abnormalities are absent then it is referred also as a cytogenetic complete remission.|Approximately 112 days|There were a total of 3 patients accrued on this trial. All were eligible and evaluable for response and evaluable for toxicity, as per protocol.||Participants|||Number
730827|NCT00398073|Secondary|Number of Participants With Response|In patients with measurable disease, the RECIST criteria for anti-tumor effect will be used. Lesions will be defined as measurable if they can be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm with conventional techniques or as > 10 mm by spiral CT scan.Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|2 years|||participants|||Number
730828|NCT00398073|Primary|Number of Participants With a T-cell Response|T-cell response: Peripheral blood lymphocytes will be tested for reactivity against gp100 using an IFN-y ELISPOT, intracellular cytokine staining or MHC tetramer assay. If T-cell reactivity is induced, additional samples may be drawn to determine the duration of this reactivity. Follow-up blood samples require only 20-30 ml. MHC tetramer assays and intracellular flow cytometry studies may also be performed.|2 years|||participants|||Number
730829|NCT00398073|Primary|Number of Patients Evulated for Toxicity and Safety|All toxicity will be graded according to the National Cancer Institute (NCI) Common Toxicity Criteria v3.0.|2 years|||participants|||Number
730830|NCT00398086|Secondary|Maximal Degree of Anemia|The maximal degree of anemia (and myelosuppression) was assessed by the overall (any time after first dose of study drug) nadir of hemoglobin levels based on clinical laboratory measurements.|During the treatment phase, up to a maximum of 24 months.|Treated patients with available data||g/L||Standard Deviation|Mean
730831|NCT00398086|Secondary|Maximal Degree of Myelosuppression|The maximal degree of myelosuppression was assessed by the overall nadir of absolute neutrophil count (ANC), white blood cell count and platelet count based on clinical laboratory measurements.|During the treatment phase, up to a maximum of 24 months.|Treated patients with available data||x10^9/L||Standard Deviation|Mean
730832|NCT00398086|Secondary|Overall Survival|Overall survival was defined as the time from the date of first dose of study drug to the date of patient death from all causes. Participants who did not die were censored at the last known time the patient was alive. Patient survival was summarized using Kaplan-Meier methods.|Up to approximately 4 years|Treated patients||months||95% Confidence Interval|Median
730833|NCT00398086|Secondary|Duration of Response|Duration of response was assessed by progression-free survival for participants who achieved a confirmed Complete Response or Partial Response, assessed by an Independent Radiological Reviewer.|Up to approximately 4 years|Treated patients with an overall confirmed Complete Response or Partial Response.||months||95% Confidence Interval|Median
730848|NCT00398216|Secondary|Change in Prothrombin Time (PT) From Baseline|change in prothrombin time (PT) from baseline to end of treatment end of treatment defined as 6-8 hours after hip replacement surgery to 7 to 10 days after the surgery|end of treatment|perp protocol analysis set||seconds||Standard Deviation|Mean
730834|NCT00398086|Secondary|Progression-free Survival|"Progression-free survival is defined as the time from first dose of study drug to the start of disease progression or patient death, whichever occurs first, assessed by an Independent Radiological Reviewer. Participants who do not have disease progression or have not died were censored at the last known time that the participant was progression free. Progression-free survival was summarized using Kaplan-Meier methods.
Progressive Disease is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of the longest diameters recorded since the treatment started; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion."|Up to approximately 4 years|Treated patients||months||95% Confidence Interval|Median
730835|NCT00398086|Secondary|Percentage of Participants With Disease Control|"Disease control is defined as participants with Stable Disease for at least 16 weeks, or confirmed complete or partial overall response, based on RECIST guidelines and assessed by an Independent Radiological Reviewer.
Stable disease is defined as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for Progressive Disease, and no new non-target lesions or unequivocal progression of existing non-target lesions. Progressive Disease is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of the longest diameters recorded since the treatment started; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion."|Up to approximately 4 years|Treated patients||percentage of participants||95% Confidence Interval|Number
730836|NCT00398086|Secondary|Percentage of Participants Who Achieved an Objective Confirmed Overall Response|"Overall Response is defined as the percent of participants who achieve an objective confirmed complete (CR) or partial response (PR). Response was determined according to Response Evaluation Criteria in Solid Tumors (RECIST) guidelines, assessed by an Independent Radiological Reviewer.
CR: The disappearance of all known disease and no new sites or disease-related symptoms confirmed at least 4 weeks after initial documentation. All sites must be assessed, including non-measurable sites, such as effusions, or markers.
PR: At least a 30% decrease in the sum of the longest diameters of target lesions, taking as a reference the baseline sum of the longest diameters confirmed at least 4 weeks after initial documentation and no new non-target lesions and/or unequivocal progression of existing non-target lesions. PR is also recorded when all measurable disease has completely disappeared, but a non-measurable component (i.e., ascites) is still present but not progressing."|Up to approximately 4 years|Treated patients||percentage of participants||95% Confidence Interval|Number
730837|NCT00398086|Secondary|Number of Participants With Adverse Events (AE)|"An AE was any untoward medical occurrence, not necessarily having a causal relationship with the patient’s treatment, that began or worsened in grade after the start of study drug through 30 days after the last dose.
A serious AE (SAE) is any untoward medical occurrence that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above.
Treatment-related AEs (TRAEs) include those assessed by the Investigator as possibly, probably, or definitely related to study treatment.
Severity was graded according to the NCI CTCAE based on the following: Grade 1- Mild; Grade 2 -Moderate; Grade 3 - Severe; Grade 4 - Life-threatening or disabling; Grade 5 - Death related to AE."|Up to 25 months|Treated patients: all enrolled patients who received at least one dose of study drug.||participants|||Number
730838|NCT00398086|Primary|Number of Participants With Dose-limiting Toxicities|"A dose-limiting toxicity (DLT) is defined as one or more of the following toxicities related to study drug during Cycle 1, according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE), Version 3:
Grade 4 neutropenia lasting >3 days in the absence of growth factor support;
Grade 4 neutropenia associated with fever >38.5°C;
Any other Grade 4 hematological toxicity;
Grade 3 thrombocytopenia with hemorrhage;
Grade 3 or 4 nausea, vomiting or diarrhea despite prophylaxis or treatment with an optimal anti-emetic or anti-diarrhea regimen;
Any other Grade 3 or higher non-hematological toxicity attributable to the study drug, excluding alopecia and fatigue."|Cycle 1 (Days 1-28)|Phase 1 treated population||participants|||Number
730839|NCT00398112|Secondary|Duration of Response|Duration of response was calculated from the documentation (date) of first response (CR or PR) until the date of progression or last follow-up in the subset of patients who responded. The median duration of response with 95%CI was estimated using the Kaplan Meier method|Duration on study (up 2 years)|No participants had a confirmed response, there for this analysis cannot be completed.|||||
730840|NCT00398112|Secondary|Progression-free Survival|Progression-free survival (PFS) was defined as the time from registration to progression or death due to any cause. The distribution of PFS was estimated using the Kaplan-Meier method.|Duration of study (up to 2 years)|||months||95% Confidence Interval|Median
730841|NCT00398112|Secondary|Survival Time|Survival time was defined as the time from registration to death due to any cause. The distribution of survival time was estimated using the Kaplan-Meier method.|Duration of study (up to 2 years)|||Months||95% Confidence Interval|Median
730842|NCT00398112|Secondary|Complete Response Rate in Patients With B-cell Chronic Lymphocytic Leukemia|Complete response is described in the primary outcome|Duration of Treatment (up to 12 cycles)|No participants had a confirmed response, there for this analysis cannot be completed.|||||
730843|NCT00398112|Primary|Number of Participants With a Confirmed Response [Complete Response (CR) and Partial Response (PR)] on 2 Consecutive Evaluations at Least 4 Weeks Apart|"National Cancer Institute working group criteria (NCIWG) was used to assess response. >
CR: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count; confirmed by bone marrow (BM) aspirate & biopsy >
PR: 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence/absence of constitutional symptoms; plus ≥1 of the following: ≥1500/μL polymorphonuclear leukocytes, >100000/μL platelets, >11.0 g/dL hemoglobin or 50% improvement for these parameters without transfusions"|Duration of Treatment (up to 12 cycles)|||participants|||Number
730844|NCT00398138|Primary|Immune Response|Immune reactivity to the peptides will be measured in the same fashion for patients with hematologic or thoracic malignancies. Immune responses will be measured by T cell proliferative response and DTH against WT-1 peptides. In patients with adequate samples, T cell gamma interferon release as measured by ELISPOT will be performed as well.|2 years|||participants|||Number
730845|NCT00398138|Primary|Safety|Toxicities will be tabulated according to the NCI Common Toxicity (version 3.0).|2 years|||participants|||Number
730849|NCT00398216|Primary|Adjudicated Incidence of VTE|"Assess the efficacy of DU-176b in the prevention of venous thromboembolism (VTE) from 6 to 8 hours after hip replacement surgery to 7 to 10 days after the surgery.
A subject was judged to have a VTE if one or more of the following criteria were met:
Observed lower extremity deep vein thrombosis (DVT) (either proximal, distal, or both ) as assessed by bilateral or unilateral ascending contrast venography prior to or at the end-of-treatment (EOT) visit
Symptomatic and objectively proven pulmonary embolism prior to or at the EOT visit
Symptomatic and objectively proven DVT prior to or at EOT visit end of treatment defined as 6 to 8 hours after after hip replacement surgery to 7 to 10 days after the surgery."|end of treatment|per protocol analysis set||percentage of participants with VTE||95% Confidence Interval|Number
730850|NCT00398320|Secondary|Biochemical Markers||Assessed every 3 weeks while on treatment|18 of 40 patients had elevated baseline hormone markers, including Chromogranin A, Gastrin, Glucagon, Pancreatic Polypeptide, vasoactive intestinal peptide (VIP), Urine 5HIAA||participants|||Number
730851|NCT00398320|Secondary|Overall Survival (OS)|OS is defined as time from enrollment until death from any cause.|Continuous|||months||Full Range|Median
730852|NCT00398320|Secondary|Response Rates|Response rate is defined as percent of patients with complete response (CR) and partial response (PR) as their best response as defined by RECIST criteria (version 1). Complete response (CR) is defined as disappearance of all target lesions. Partial Response (PR) is defined as ≥ 30 decrease in the sum of longest diameters of target lesions (SLD). Overall response (OR) = CR + PR.|Response rates by RECIST criteria assessed every 3 months while on treatment|||percentage of participants|||Number
730853|NCT00398320|Primary|Number of Patients Who Experienced Treatment-related Grade 3 or Higher Adverse Events by CTCAE Version 3.0|Participants were monitored every 3 weeks while on study. Toxicity and attributions were as per CTCAE version 3.0 guidelines. Analysis population below is patient who experienced related Grade 3 or higher AE; denominator is 40 total patients enrolled.|30 days after last treatment|||participants|||Number
730854|NCT00398320|Primary|12-month Progression Free Survival (PFS)|Percentage of participants with 12-month progression-free survival (PFS) was assessed. PFS is defined as the time from enrollment until documented disease progression or death (whichever occurred first). RECIST criteria (version 1). Complete response (CR) defined as disappearance of all target lesions. Partial Response (PR) defined as ≥ 30% decrease of SLD. Progressive disease (PD) defined as ≥ 20% increase in Sum Longest Diameters (SLD). Stable Disease (SD) defined as being between 20% increase and < 30% decrease in SLD.|PFS assessed every 3 months through 12 months|||percentage of participants w/ 12 mo PFS|||Number
730855|NCT00398398|Secondary|Toxicity Profile|Number of patients who experienced toxicity from study treatment to evaluate the safety and tolerability of XELOX plus Cetuximab|1 years|||participants|||Number
730856|NCT00398398|Secondary|Overall Survival||1 year|||months||95% Confidence Interval|Median
730857|NCT00398398|Secondary|Progression-free Survival||1 year|||months||95% Confidence Interval|Median
730858|NCT00398398|Primary|Overall Response Rate|Tumor response was evaluated every two cycles by CT scans and other indicated methods, and the patients with complete or partial response required a confirmatory response evaluation at least 4 weeks later. Patients without confirmatory evaluation were not regarded as responders.|6 months|||participants|||Number
730859|NCT00398411|Secondary|Overall Survival||follow up visit (at discharge from hospital up to a maximum of 28 days after transplantation)|intention to treat (ITT)||participants|||Number
730860|NCT00398411|Secondary|Type of Infection||follow up visit (at discharge from hospital up to a maximum of 28 days after transplantation)|intention to treat (ITT)||participants|||Number
730861|NCT00398411|Secondary|Reason for Discontinuation of Treatment|Absolute neutrophil count (ANC) recovered to > 500 /µl on two consecutive days Maximum of 20 days of treatment Occurrence of fever >= 38°C Systemic antibiotic treatment despite patient being afebrile Death Other adverse event (AE) Other reason|end of treatment (mean duration of treatment was 9.7 days; 10.2 days in moxifloxacin arm, 9.2 days in placebo arm)|intention to treat (ITT)||participants|||Number
730862|NCT00398411|Secondary|Time to Occurrence of Fever >= 38°C||end of treatment (mean duration of treatment was 9.7 days; 10.2 days in moxifloxacin arm, 9.2 days in placebo arm)|intention to treat (ITT)||days||Standard Deviation|Mean
730863|NCT00398411|Secondary|Type of Isolates and Infections||end of treatment (mean duration of treatment was 9.7 days; 10.2 days in moxifloxacin arm, 9.2 days in placebo arm)|intention to treat (ITT)||participants|||Number
730864|NCT00398411|Primary|Incidence of Clinically Significant Bacteremia|"Failure was defined as clinically significant bacteraemia occurring in the period of neutropenia and an intervention with a systemic antibacterial becoming necessary.
With this being a discontinuation criteria and the outcome being measured at end of treatment, only one episode is taken into account for each participant."|end of treatment (mean duration of treatment was 9.7 days; 10.2 days in moxifloxacin arm, 9.2 days in placebo arm)|intention to treat (ITT)||participants|||Number
730865|NCT00391716|Secondary|Craving|Alcohol Craving Questionnaire has 12 questions about alcohol craving which are each scored 1-7, then summed for a weekly score between 7 and 84, with higher scores indicating greater craving. Cumulative mean total craving scores are tested by ANOVA for differences between treatment groups.|12-week|||units on a scale||Standard Error|Mean
730866|NCT00391716|Secondary|Sleep|The Pittsburgh Sleep Questionnaire Inventory consists of 9 questions about sleep habits which are answered on a scale of 0-3. Results are sorted into 7 sub scales re-scored 0-3, then sub scales are summed for a weekly total score between 0 and 21, with higher total scores indicating greater sleep impairment. Cumulative mean total sleep scores over the 12 weeks of study are assessed by ANOVA for differences between treatment groups.|12-week|||units on a scale||Standard Error|Mean
730867|NCT00391716|Secondary|Mood|Beck Depression Inventory II consists of 21 questions assessing depression symptoms answered with scores between 0 and 3, summed for a weekly total score between 0 and 63; higher scores indicate more depression. The cumulative mean total depression scores over the 12 week study are tested by ANOVA for differences in cumulative means between treatment groups.|12-week|||units on a scale||Standard Error|Mean
730868|NCT00391716|Primary|Drinking|Rate of complete abstinence was defined as the number of participants who drank no alcohol during 12 weeks of treatment, where the denominator is the intent to treat population. Rate of heavy drinking abstinence is defined as no heavy drinking days while on study (4 or more for women, 5 or more for men).|12-week|All randomized subjects included in denominator for rate determination.||participants|||Number
730869|NCT00391768|Secondary|Correlation of Clearance of Viral RNA by Polymerase Chain Reaction (PCR) to Pharmacokinetic Parameters by Cohort.|The Spearman coefficient and the p-values were computed between the clearance of viral RNA and oseltamivir carboxylate Area Under the Curve from 0 to 12 hours (AUC 0-12)|From date of enrollment until the date of first documented absence of viral load by culture, assessed up to 10 days after enrollment.|Subjects included in this analysis are those who had viral loads at baseline (day 0) and had a non-detectable viral load on one of the following study visit days: day 3, day 5, or day 10. Virus was obtained from a nasal swab. Subjects also would have had evaluable PK samples on study day 3.||correlation measure|||Number
730870|NCT00391768|Secondary|Correlation of Clearance of Viral RNA by Culture With Pharmacokinetic Parameters by Cohort|The Spearman coefficient and the p-values were computed between the clearance of Viral RNA and Oseltamivir Carboxylate Area under the curve from 0 to 12 hours (AUC0-12)|Day to negative viral load for subjects positive at baseline|Subjects included in this analysis are those who had positive culture at baseline (day 0) and had a negative culture on one of the following study visit days: Day 3, Day 5 or Day 10. Culture was obtained from a a nasal swab. Subjects also would have had evaluable PK samples on study day 3.||Spearman coefficient|||Number
730871|NCT00391768|Secondary|Incidence of All Serious Adverse Events by Cohort and System Organ Class (SOC)|Serious Adverse Event (SAE) were classified by MedDRA System Organ Class (SOC). An SAE was reported if it met the following criteria and occurred after the first dose of study medication through the end of the study: death throughout study participation; life threatening; requires inpatient hospitalization or prolongation of existing hospitalization during the period of protocol defined surveillance; results in congenital anomaly or birth defect; results in a persistent or significant disability; and an event considered serious by the PI.|Duration of study, from receipt of the first dose of study drug and continuing through study visit Day 30 plus or minus 3 days|||Participants|||Number
730872|NCT00391768|Secondary|Incidence of Treatment Emergent AEs and Drug Related AEs by Cohort Leading to Discontinuation of Study Medication|Study drug was administered for 5 days; any event that occurred prior to the last dose of study medication that was considered related to an AE and that caused the subject to stop taking study drug.|Duration of study, from receipt of the first dose of study drug and continuing through study visit Day 5 plus or minus 1 day|||events|||Number
730873|NCT00391768|Secondary|Incidence of Treatment Emergent AEs and Drug Related AEs by Cohort and Toxicity Grade|Any event considered to be related to the study drug that occurred post first dose of drug administration that was not present at baseline was considered an AE. Expected flu symptoms were not reported as AEs but were collected separately. The Division of AIDS Toxicity Tables (DIAIDS) were used to grade the events.|Duration of study, from receipt of the first dose of study drug and continuing through study visit Day 30 plus or minus 3 days|Intention to treat (ITT)||Participants|||Number
730874|NCT00391768|Secondary|Number and Characteristics of Adverse Events (AEs) Described as Neurological Events.|Any neurological event that occurred post first dose of drug administration that was not present at baseline was considered an AE. Expected flu symptoms were not reported as AEs but were collected separately.|Duration of study, from receipt of the first dose of study drug and continuing through study visit Day 30 plus or minus 3 days.|Intention to treat (ITT)||participants|||Number
730875|NCT00391768|Secondary|Overall Reported Adverse Events (AEs) Thought to be Associated With Study Therapy.|Any event considered associated with drug that occurred post first dose of drug administration that was not present at baseline was considered an AE. Expected flu symptoms were not reported as AEs but were collected separately.|Duration of study, from receipt of the first dose of study drug and continuing through study visit Day 30 plus or minus 3 days.|Intention to treat (ITT)||participants|||Number
730876|NCT00391768|Primary|Oseltamivir Carboxylate AUC12 (Area Under the Curve).|The oseltamivir carboxylate AUC12 was derived from a series of five blood draws over 10 to 12 hours.|Day 3 of drug administration|Subjects that received 3 days study drug administration and had successful PK draws on study day 3.||participants|||Number
730877|NCT00391807|Secondary|Percentage of Subjects With Amenorrhea, Cycle 13, MITT Population||13 cycles, 28 days each (1 year)|MITT Population||Percentage of Participants|||Number
730878|NCT00391807|Secondary|Percentage of Subjects With Amenorrhea, Cycle 6, MITT Population||6 cycles, 28 days each (168 days)|MITT Population||Percentage of Participants|||Number
730879|NCT00391807|Secondary|Percentage of Subjects With Amenorrhea, Cycle 2, MITT Population||2 cycles, 28 days each (56 days)|MITT Population||Percentage of Participants|||Number
730880|NCT00391807|Secondary|Total Number of Bleeding Days Per Cycle, Cycle 13, MITT Population||13 cycles, 28 days each (1 year)|MITT Population||Days||Standard Deviation|Mean
730881|NCT00391807|Secondary|Total Number of Bleeding Days Per Cycle, Cycle 6, MITT Population||6 cycles, 28 days each (168 days)|MITT Population||Days||Standard Deviation|Mean
730882|NCT00391807|Secondary|Total Number of Bleeding Days Per Cycle, Cycle 2, MITT Population||2 cycles, 28 days each (56 days)|MITT Population||Days||Standard Deviation|Mean
730883|NCT00391807|Secondary|Median Duration of Withdrawal Bleeding, Cycle 12, MITT Population||12 cycles, 28 days each (336 days)|MITT Population||Days||Standard Deviation|Median
730884|NCT00391807|Secondary|Median Duration of Withdrawal Bleeding, Cycle 6, MITT Population||6 cycles, 28 days each (168 days)|MITT Population||Days||Standard Deviation|Median
730885|NCT00391807|Secondary|Median Duration of Withdrawal Bleeding, Cycle 2, MITT Population||2 cycles, 28 days each (56 days)|MITT Population||Days||Standard Deviation|Median
730886|NCT00391807|Secondary|Percentage of Subjects With Withdrawal Bleeding (%), Cycle 13, MITT Population||13 cycles, 28 days each (1 year)|MITT Population||Percentage of Participants|||Number
730887|NCT00391807|Secondary|Percentage of Subjects With Withdrawal Bleeding (%), Cycle 6, MITT Population||6 cycles, 28 days each (168 days)|MITT Population||Percentage of Participants|||Number
730888|NCT00391807|Secondary|Percentage of Subjects With Withdrawal Bleeding (%), Cycle 2, MITT Population||2 cycles, 28 days each (56 days)|MITT Population||Percentage of Participants|||Number
730889|NCT00391807|Secondary|Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 13, MITT Population|MITT Population|13 cycles, 28 days each (1 year)|MITT Population||Bleeding/Spotting Days||Standard Deviation|Mean
730890|NCT00391807|Secondary|Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 6, MITT Population|MITT Population|6 cycles, 28 days each (168 days)|MITT Population||Bleeding/Spotting Days||Standard Deviation|Mean
730891|NCT00391807|Primary|Pregnancy Rate (Expressed as Pearl Index) in Women Aged 18-45, MITT Population||13 Cycles, 28 days each (1 year)|MITT Population, All Subjects 18-45 years old, 27 women had no cycles evaluable for pregnancy because they used alternative contraceptive methods in all cycles - 1555 subjects evaluable in MITT population. Number of pregnancies per 100 women-years of treatment in MITT Population||Pregnancy Rate|Participants||Number
730892|NCT00391807|Secondary|Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 2, MITT Population|MITT Population|2 Cycles, 28 days each (56 days)|MITT Population||Bleeding/Spotting Days||Standard Deviation|Mean
730893|NCT00391807|Primary|Pregnancy Rate (Expressed as Pearl Index) in Women Aged 18 to 35, MITT Population,||13 cycles, 28 days each (1 year)|Modified Intent to Treat Population (MITT), Women Aged 18-35, 27 women had no cycles evaluable for pregnancy because they used alternative contraceptive methods in all cycles - 1555 subjects evaluable in MITT population. Number of pregnancies per 100 women-years of treatment in MITT Population||Pregnancy Rate|Participants||Number
730894|NCT00391846|Secondary|Discontinuations|Number of patients discontinued due to adverse events’|9 months|In the above analysis regarding The number of participants analyzed the ‘last observation carried forward’ principle is used, as pre-specified in the protocol.||Participants|||Number
730895|NCT00391846|Secondary|Total Number of Titration Steps in Prescribed Heart Failure Treatment|Each titration step in prescribed medication is counted as one step, either up or down. One step up indicates an increase of dose in prescribed medication and one step down indicates a decrease of dose in prescribed medication. The sum of steps is given as a score. Score is given for each arm as a total number of titration steps for all patients in arm.|9 months|In the above analysis regarding The number of participants analyzed the ‘last observation carried forward’ principle is used, as pre-specified in the protocol.||Titration steps|||Number
730896|NCT00391846|Secondary|Changes in Health-related Quality of Life|Change range –100 to 100. The higher the better.|9 months and baseline|In the above analysis regarding The number of participants analyzed the ‘last observation carried forward’ principle is used, as pre-specified in the protocol.||KCCQ overall score||Standard Error|Mean
730897|NCT00391846|Secondary|Changes in NT-proBNP Values Over Time in All Patients|The 95% confidential interval (CI) is given as measure of dispersion|9 months and baseline|In the above analysis regarding The number of participants analyzed the ‘last observation carried forward’ principle is used, as pre-specified in the protocol.||ng/L||95% Confidence Interval|Geometric Mean
730898|NCT00391846|Secondary|Changes in Heart Failure Symptoms|Changes from baseline in the symptom score subset (question 3, 5, 7 and 9) of KCCQ (swelling, fatigue, shortness of breath, shortness of breath night time). KCCQ is a self-administered by patient symptom score, where higher score reflect better health status. Scale scores are transformed to a 0 to 100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100. This mean that the KCCQ scale is from 0 to 100 with the higher value showing a better health status.|9 months and baseline|In the above analysis regarding The number of participants analyzed the ‘last observation carried forward’ principle is used, as pre-specified in the protocol.||Categorial scale||Standard Deviation|Mean
730899|NCT00391846|Secondary|Number of Days in Hospital for CV Reason|Each overnight stay is counted as one day. The lower the better|9 months|In the above analysis regarding The number of participants analyzed the ‘last observation carried forward’ principle is used, as pre-specified in the protocol.||Days in hospital||Standard Deviation|Mean
730900|NCT00391846|Secondary|Number of CV Deaths|Number of deaths|9 months|In the above analysis regarding The number of participants analyzed the ‘last observation carried forward’ principle is used, as pre-specified in the protocol.||Participants|||Number
730901|NCT00391846|Primary|Composite Value of 3 Variables After 9 Months: Cardiovascular Death (Days Alive), Cardiovascular Hospitalization (Days Out of Hospital), Heart Failure Symptoms (Symptom Score Subset of the Kansas City Cardiomyopathy Questionnaire - Questions 3,5,7,9)|The non-parametric scale is constructed from 3 variables, modified after Cleland. Each patient receives a rank score from 1 to 246 (246-number of patients in the study). The lowest score receive patients who die (due to CV event), next patients still alive at end-of-study with the worst composite score, the best alive patients with 0 days in hospital and the largest improvement in the KCCQ (self-administered by patient symptom score, where the higher score reflect better health status). Scores will be summarized using non-parametric calculations. The mean of non-parametric scores is presented|9 months|In the above analysis regarding The number of participants analyzed the ‘last observation carried forward’ principle is used, as pre-specified in the protocol.||Scores on a scale||Standard Deviation|Mean
730902|NCT00391872|Secondary|Participants With Ventricular Pauses of Greater Than or Equal to 3 Seconds in Patients Monitored by Holter 24 Hour ECG Recorders for 1 Week at 1 Month Following Randomization|Number of participants who were observed to have at least 1 ventricular pause of at least 3 seconds. Population is all patients who were observed over 2 week-long periods. Pauses were flagged algorithmically and confirmed by TIMI cardiologists.|1-week period following randomization|Patients who were monitored for one week following randomization (and for one week one month later).||Participants|||Number
730903|NCT00391872|Secondary|Participants With Ventricular Pauses of Greater Than or Equal to 3 Seconds in Patients Monitored by Holter 24-hour ECG Recorders for 1 Week Following Randomization|Number of participants who were observed to have at least 1 ventricular pause of at least 3 seconds. Population is all patients who were observed over 2 week-long periods. Pauses were flagged algorithmically and confirmed by Thrombolysis in Myocardial Infarction (TIMI) group cardiologists.|1-week period following randomization|Participants with Holter data in the week after Randomization||Participants|||Number
730904|NCT00391872|Secondary|Participants With Coronary Artery Bypass Graft (CABG) Major Fatal/Life-threatening Bleeding|Number of participants with a major fatal/life-threatening CABG-related bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. All CABG surgeries were submitted for adjudication by an endpoint committee as potential bleeds.|First dosing up to 12 months|Population is all patients who underwent CABG surgery within 7 days of last dose of active study medication.||Participants|||Number
731040|NCT00401258|Primary|Abdominal Pain, as Determined by Daily Pain Diaries (Patterned After Item 3 From the Brief Pain Inventory; Cleeland and Ryan, 1994).|Subjects rated abdominal pain daily on a scale of 0-10 (0 being no pain and 10 being worst pain). The pain score at each visit represented the mean score from all days since the previous visit.|baseline and week 12|||Units on a scale||95% Confidence Interval|Mean
730905|NCT00391872|Secondary|Participants With Coronary Artery Bypass Graft (CABG) Major Bleeding|Participants with a major CABG-related bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. All CABG surgeries were submitted for adjudication by an endpoint committee as potential bleeds.|First dosing up to 12 months|Population is all patients who underwent CABG surgery within 7 days of last dose of active study medication.||Participants|||Number
730906|NCT00391872|Secondary|Participants With Non-procedural Major Bleeding|Participants with non-procedural major bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. Events were adjudicated by an endpoint committee.|First dosing up to 12 months|The population was the safety analysis set, which included all randomized patients who took at least one dose of study drug||Participants|||Number
730907|NCT00391872|Secondary|Participants With Major or Minor Bleeding|Participants with major (fatal/life-threatening or other) or minor bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. Events were adjudicated by an endpoint committee.|First dosing up to 12 months|The population was the safety analysis set, which included all randomized patients who took at least one dose of study drug||Participants|||Number
730908|NCT00391872|Secondary|Participants With Non-CABG (Coronary Artery Bypass Graft) Related Major Bleeding|Participants with non CABG related major (fatal/life-threatening or other) bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. Events were adjudicated by an endpoint committee.|First dosing up to 12 months|The population was the safety analysis set, which included all randomized patients who took at least one dose of study drug||Participants|||Number
730909|NCT00391872|Secondary|Participants With Death From Any Cause|Participants with death from any cause. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT (intention to treat) analysis of whole population. Events were adjudicated by an endpoint committee.|Randomization up to 12 months|The population was the full analysis set, which included all randomized patients||Participants|||Number
730910|NCT00391872|Secondary|Participants With Stroke|Participants with stroke. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT (intention to treat) analysis of whole population. Events were adjudicated by an endpoint committee.|Randomization up to 12 months|The population was the full analysis set, which included all randomized patients||Participants|||Number
730911|NCT00391872|Secondary|Participants With Death From Vascular Causes|Participants with death from vascular causes. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT (intention to treat) analysis of whole population. Events were adjudicated by an endpoint committee.|Randomization up to 12 months|The population was the full analysis set, which included all randomized patients||Participants|||Number
730912|NCT00391872|Secondary|Participants With MI Event|Participants with MI event. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT (intention to treat) analysis of whole population. Events were adjudicated by an endpoint committee.|Randomization up to 12 months|The population was the full analysis set, which included all randomized patients||Participants|||Number
730913|NCT00391872|Secondary|Participants With Any Event From the Composite of Death From Vascular Causes, MI (Including Silent), Stroke, Recurrent Ischemia, Transient Ischemic Attack (TIA) and Other Arterial Thrombotic Events.|Participants with death from vascular causes, MI, stroke, recurrent ischemia, or other thrombotic events. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT analysis of whole population. Events were adjudicated.|Randomization up to 12 months|The population was the full analysis set, which included all randomized patients||Participants|||Number
730914|NCT00391872|Secondary|Participants With Any Event From the Composite of All-cause Mortality, MI, and Stroke|Participants with death from any cause, MI, or stroke. If no event, censoring occurs at the earliest of patient withdrawal of consent or date of scheduled withdrawal from therapy. ITT analysis of whole population. Events were adjudicated by an endpoint committee.|Randomization up to 12 months|The population was the full analysis set, which included all randomized patients||Participants|||Number
730915|NCT00391872|Secondary|Participants With Any Event From the Composite of Death From Vascular Causes, MI, and Stroke for the Subgroup of Patients With Intent for Invasive Management at Randomization|Participants with death from vascular causes, MI, or stroke. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT analysis of intent for invasive management population. Events were adjudicated by an endpoint committee.|Randomization up to 12 months|The subgroup of patients with intent for invasive management at randomization||Participants|||Number
730916|NCT00391872|Primary|Participants With Any Major Bleeding Event|Participants with major (fatal/life-threatening or other) bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. Events were adjudicated by an endpoint committee.|First dosing up to 12 months|The population was the safety analysis set, which included all randomized patients who took at least one dose of study drug||Participants|||Number
730917|NCT00391872|Primary|Participants With Any Event From the Composite of Death From Vascular Causes, Myocardial Infarction (MI), and Stroke|Participants with death from vascular causes, MI, or stroke. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. Intention To Treat (ITT) analysis of whole population. Events were adjudicated by an endpoint committee.|Randomization up to 12 months|The population was the full analysis set, which included all randomized patients||Participants|||Number
730918|NCT00391898|Secondary|Change on the QUICK Questionnaire (QQ) Score From Baseline to Month 3|The QQ is a self-administered questionnaire that includes 19 wearing-off (WO) symptoms (motor and non-motor). A positive answer to each of the 19 symptoms is given by patients if they presented with a symptom and the symptom disappeared after the next drug dose. Two positive answers are diagnostic of wearing-off (WO). A negative change score indicates improvement.|Baseline to end of study (Month 3)|Per Protocol set with LOCF||Positive answers||Standard Deviation|Mean
731041|NCT00401401|Secondary|Best Overall Tumor Response|Tumour response according to RECIST criteria J Natl Cancer Inst 2000;92:205-16 assessed by CT/MRI. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the longest diameter of target lesions; Overall Response (OR), CR+PR|Up to 3 years|||Participants|||Number
730919|NCT00391898|Secondary|Patient and Investigator Global Evaluation of the Patient|Both the patient and the investigator made an evaluation of the change in the patient’s condition by rating the condition of the patient at the end of the study compared to patient’s condition at baseline. The rating was made on a scale ranging from -3 to +3: (-3: Very much improved, -2: much improved, -1: mild improvement, 0: no change, +1: mild deterioration, +2: much deterioration, +3: very much deterioration). A negative score indicates improvement.|Baseline to end of study (Month 3)|Per Protocol set with LOCF||Units on a scale||Standard Deviation|Mean
730920|NCT00391898|Secondary|Change in the 39-item Parkinson's Disease Questionnaire (PDQ-39) Total Score From Baseline to Month 3|The PDQ-39 is an instrument used to assess quality of life in individuals with Parkinson’s disease. The questionnaire provides scores on eight scales: Mobility, activities of daily living, emotions, stigma, social support, cognitions, communication, and bodily discomfort. Questions are scored on a 5-point Likert scale ranging from 1 (never) to 3 (sometimes) to 5 (always). The total score can range from 39 to 195. A lower score indicates better quality of life. A positive change score indicates an improvement.|Baseline to end of study (Month 3)|Per Protocol set with LOCF||Units on a scale||Standard Deviation|Mean
730921|NCT00391898|Secondary|Change in the UPDRS Part IV (Complications of Therapy) Score From Baseline to Month 3|Part IV of the UPDRS measures complications the patient may be experiencing with therapy and was only collected at and after the visit at which the first dyskinesia or episode of wearing-off was recorded. Part IV is composed of 3 sections and 11 items: A (32-35, dyskinesia), B (36-39, clinical fluctuations, C (40-42, other complications) (total score 0-23, calculated as the sum of the individual items). A lower total score indicates greater symptom control. A negative change score indicates improvement.|Baseline to end of study (Month 3)|Per Protocol set with LOCF||Units on a scale||Standard Deviation|Mean
730922|NCT00391898|Secondary|Change in the UPDRS Part III (Motor Function) Score From Baseline to Month 3|The UPDRS is a standardized assessment scale used to measure a patient's disease state. It is completed by a blinded rater. There are 6 parts to the UPDRS. Part III (items 18-31; total score 0-56, calculated as the sum of the individual items) measures the patient’s motor function. A lower total score indicates greater symptom control. A negative change score indicates improvement.|Baseline to end of study (Month 3)|Per Protocol set with LOCF||Units on a scale||Standard Deviation|Mean
730923|NCT00391898|Secondary|Change in the UPDRS Part I (Mentation, Behavior, and Mood) Score From Baseline to Month 3|The UPDRS is a standardized assessment scale used to measure a patient's disease state. It is completed by a blinded rater. There are 6 parts to the UPDRS. Part I (items 1-4; total score 0-16, calculated as the sum of the individual items) measures the patient’s mentation, mood and behavior. A lower total score indicates greater symptom control. A negative change score indicates improvement.|Baseline to end of study (Month 3)|Per Protocol set with LOCF||Units on a scale||Standard Deviation|Mean
730924|NCT00391898|Primary|Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living [ADL]) Score From Baseline to Month 3|The UPDRS is a standardized assessment scale used to measure a patient's disease state. It is completed by a blinded rater. There are 6 parts to the UPDRS. Part II (items 5-17; total score 0-52, calculated as the sum of the individual items) measures the patient's activities of daily living. A lower total score indicates greater symptom control. A negative change score indicates improvement.|Baseline to end of study (Month 3)|Per Protocol set with the last observation carried forward (LOCF)||Units on a scale||Standard Deviation|Mean
730925|NCT00391976|Secondary|Number of Participants Hospitalized for Pulmonary Exacerbations|Core study defined as from Baseline through to one month after the end of treatment (Day 56 for the 28-day treatment group and Month 3 for the 56-day treatment group). Follow-up phase began at the end of the core study through to the end of the study (Month 27).|From Baseline to end of study (27 months)|All patients who were randomized and received at least one dose of study medication. Non-randomized patients were not included in the analysis.||Participants|||Number
730926|NCT00391976|Secondary|Percentage of Patients With Pseudomonas (P.) Aeruginosa Having an Increased, Decreased, or Unchanged Tobramycin Minimum Inhibitory Concentration (MIC) Value at the Final Visit Compared to Baseline|The percentage of patients with changes in tobramycin MIC values from Baseline to the final visit could not be compared as there was insufficient data.|From Baseline to the final visit (end of the study, Month 27)|Safety population: All patients who were enrolled in the study and received at least 1 dose of study medication.||Percentage of participants|||Number
730927|NCT00391976|Secondary|Time to Recurrence of Pseudomonas (P.) Aeruginosa (New or Same Genotype) in Sputum or Deep Throat Cough Swab Based on Confirmatory Assessment by the Central Laboratory|Time to recurrence was defined as the time between the visit at 1 month after the end of treatment (when eradication was confirmed) and the time of the first positive culture with any genotype of P. aeruginosa. Time zero was Day 56 (Month 2) for the 28-day treatment group and Month 3 for the 56-day treatment group.|From 1 month after the end of treatment until the end of the study (Month 27)|Efficacy evaluable population: All randomized patients who had microbiological assessments 1 month after their last dose of study drug, except for patients with no eradication 1 month after the last dose of study drug, low compliance (> 50% of capsules returned unused), or violation of protocol procedure in relation to the efficacy analysis.||Months||95% Confidence Interval|Median
730928|NCT00391976|Secondary|Percentage of Patients With Pseudomonas (P.) Aeruginosa Eradicated From Deep Throat Cough Swab or Sputum|One month after the end of treatment was Day 56 (Month 2) for the 28-day treatment group and Month 3 for the 56-day treatment group.|From 1 month after the end of treatment until the end of the study (Month 27)|Efficacy evaluable population: All randomized patients who had microbiological assessments 1 month after their last dose of study drug, except for patients with no eradication 1 month after the last dose of study drug, low compliance (> 50% of capsules returned unused), or violation of protocol procedure in relation to the efficacy analysis.||Percentage of participants|||Number
730946|NCT00392223|Primary|Change From Baseline to End of Treatment in Global Acne Grading System (GAGS) Score|GAGS used to assess 6 locations on face/chest/upper back; factor for each location based on surface area, distribution, density of pilosebaceous units. Locations graded separately 0 - 4 (hi). Global score factored based on summing of local scores. Change: (Global) score at observation minus (global) score at baseline.|Baseline, Week 8 End of Treatment (EOT)|Full Analysis Set, Last Observation Carried Forward (LOCF)||score on scale||95% Confidence Interval|Least Squares Mean
730929|NCT00391976|Primary|Time to Recurrence of Pseudomonas (P.) Aeruginosa (Any Genotype) in Sputum or Deep Throat Cough Swab|Microbiological samples were obtained from sputum or by deep throat cough swab technique. Time to recurrence was defined as the time between the visit at 1 month after the end of treatment (when eradication was confirmed) and the time of the first positive culture with any genotype of P. aeruginosa. Time zero was Day 56 (Month 2) for the 28-day treatment group and Month 3 for the 56-day treatment group. Kaplan-Meier estimates were used.|From 1 month after the end of treatment (Day 56 for the 28-day treatment group and Month 3 for the 56-day treatment group) until the end of the study (Month 27)|Efficacy evaluable population: All randomized patients who had microbiological assessments 1 month after their last dose of study drug, except for patients with no eradication 1 month after the last dose of study drug, low compliance (> 50% of capsules returned unused), or violation of protocol procedure in relation to the efficacy analysis.||Months||95% Confidence Interval|Median
730930|NCT00391989|Secondary|OS, Defined as the Time Interval Between Inclusion and Death for Any Cause.||End of study||||||
730931|NCT00391989|Secondary|the Cumulative Incidence of Relapse;||End of study||||||
730932|NCT00391989|Secondary|DFS, Defined as the Time Interval Between the Evaluation of HCR and Hematological Relapse of the Disease or Death in First HCR;||End of study||||||
730933|NCT00391989|Secondary|the Best Molecular Response Obtained During BMS Treatment Within Day +85, Whenever Achieved From the Start of the Experimental Drug;||End of study||||||
730934|NCT00391989|Secondary|The Best Cytogenetic Response Obtained During BMS Treatment Within Day +85, Whenever Achieved From the Start of the Experimental Drug;||End of study||||||
730935|NCT00391989|Secondary|The Incidence of Grade >2 CTC-NCI Side Effects and Toxicities;||End of study||||||
730936|NCT00391989|Primary|Rate of Hematological Complete Remission (HCR) Obtained During the BMS Induction Treatment Within Day +85 From the Start of BMS (i.e., Whenever Achieved From the Start of the Experimental Drug).||End of the study, up to day 85|||Patients|||Number
730937|NCT00392171|Primary|Percentage of Participants Surviving at Six Months of Treatment Without Evidence of Disease Progression.|Progression-free survival as determined by Kaplan-Meier method.|6 months|"Participants who received allocated intervention.
The percentage of participants reported is based on the number of participants within each category (not total number of all categories combined)."||Percentage of Participants|||Number
730938|NCT00392197|Secondary|HbA1c|The number of subjects with an HbA1c value of 6.5% or higher were calculated. In addition, for 5.8% and above, the number of subjects were also calculated, in the same way|Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 52, or discontinuation|||participants|||Number
730939|NCT00392197|Primary|Fasting Blood Glucose (FBS) Level (if Fasting Blood Glucose Level Was Not Available, Non-fasting Blood Glucose (Non-FBS) Level)|The number of subjects whose FBS level reached or exceeded 126 mg/dL (200 mg/dL, non-FBS level) at least once during the test product administration period as well as the incidence were determined. Also, for 110 mg/dL and above (140 mg/dL, non-FBS level), the number of subjects were determined in the same way.|Prior to the start of administration (Baseline) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 52, or discontinuation|Subjects who were treated with at least 1 tablet of the test product, and whose blood glucose level was measured at least once after test product administration were included in the glucose metabolism analysis set. However, subjects who violated inclusion criteria and exclusion criteria were excluded.||participants|||Number
730940|NCT00392210|Primary|Number of Participants Who Passed Bladder Trial|Voiding trial 1 was performed according to the patient assignment to group 1 or 2. Voiding trial 2 was done immediately after completion of trial 1. A successful trial was defined as a void of greater than two-thirds of total bladder volume (voided volume + post-void residual urine).|postoperatively after surgery on day1 or 2|||participants|||Number
730941|NCT00392223|Secondary|Change From Baseline in Acne Graded by Leeds Technique|Leeds Grading technique: evaluates three sites (face, back, chest) on a 0 to 10 grading scale where 0 equals to no acne and 10 equals to most severe acne.|Baseline, Week 4, Week 8 End of Treatment (EOT), 8 weeks after EOT|Full Analysis Set. Where noted: LOCF = Last Observation Carried Forward technique was used. Number of subjects with analyzable data: n=azithromycin, minocycline (respectively).||score on scale||95% Confidence Interval|Mean
730942|NCT00392223|Primary|Change From Baseline to End of Treatment (EOT) in Global Acne Grading System (GAGS) Score - Per Protocol Population|GAGS used to assess 6 locations on face/chest/upper back; factor for each location based on surface area, distribution, density of pilosebaceous units. Locations graded separately 0 - 4 (hi). Global score factored based on summing of local scores. Change: (Global) score at observation minus (global) score at baseline.|Baseline, Week 8 EOT|Per Protocol population||score on scale||95% Confidence Interval|Least Squares Mean
730943|NCT00392223|Secondary|Improvement of Global Acne Grading System (GAGS) Score|Number of subjects by improvement category of GAGS score: Best improvement = reduction of GAGS score >75% (pre-post evaluation); Good improvement = reduction score > 50 – 75%; Moderate improvement : reduction score > 25 – 50%; Light improvement : reduction score > 0 – 25%; No change = reduction score = 0%; Worsening = increase score > 0 %.|Week 4, Week 8 End of Treatment (EOT), 8 weeks after EOT|Full Analysis Set. Where noted: LOCF = Last Observation Carried Forward technique was used.||participants|||Number
730944|NCT00392223|Post-Hoc|Number of Subjects With Mild, Moderate, and Severe Acne|Global Acne Grading System score used to assess 6 locations on face/chest/upper back; factor for each based on area, distribution, density of pilosebaceous units. Locations graded separately 0 - 4 (hi). Global score factored based on sum of local scores and se verity: 0=no acne, 1-18=mild, 19-30=moderate, 31-38=severe, >39=very severe.|Baseline, Week 8 End of Treatment (EOT)|Full Analysis Set. Where noted: LOCF = Last Observation Carried Forward technique was used.||participants|||Number
730945|NCT00392223|Secondary|Change From Baseline in Global Acne Grading System (GAGS) Score|GAGS used to assess 6 locations on face/chest/upper back; factor for each location based on surface area, distribution, density of pilosebaceous units. Locations graded separately 0 - 4 (hi. Global score factored based on summing of local scores. Change: mean at observation minus baseline.|Baseline, Week 4, Week 8 End of Treatment (EOT), 8 weeks after EOT|Full Analysis Set. Where noted: LOCF = Last Observation Carried Forward technique was used. Number of subjects with analyzable data: n=azithromycin, minocycline (respectively).||score on scale||95% Confidence Interval|Mean
730954|NCT00398632|Primary|Global Clinical Impressions Improvement Score re Sexual Functioning|The GCI-I score is a global clinical impression score regarding a patient's symptom severity change rated by the treating clinician. The score can be 0 (not assessed), 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse) or 7 (very much worse). In this study clinicians made ratings based on interviewing the patient and reviewing the patient's self ratings on the the Arizona Sexual Experiences Scale (ASEX). No formal cut point scores on the ASEX were established. The ASEX is a 5-item slef rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach organism, and satisfaction from orgasm. Each item is rated from 1 to 6 (total scores from 5 to 30), with higher scores indicating greater sexual dysfunction.|baseline and last observation (4 subjects at end of week 12, 2 subjects at end of week 6)|Four subjects completed the study; two withdrew at end of week six. CGI-I ratings for two subjects were done at end of week 6 and this last observation was carried forward in the analysis. CGI-I ratings for the 4 completing subjects were done at end of week 12.||participants|||Number
730955|NCT00398866|Secondary|Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire|Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire measures degree of disability on a scale of 0 to 100, with a higher score indicating greater disability.|Baseline, 26 Weeks|Patients who completed follow-up through 26 weeks||units on a scale||Standard Deviation|Mean
730956|NCT00398866|Primary|Pain Visual Analogue Scale (VAS)|Pain intensity measured on a Visual Analog Scale with scores ranging from 0 to 100, with 100 = severe pain.|Baseline, 26 Weeks|Patients who completed follow-up through 26 weeks||Units on a scale||Standard Deviation|Mean
730957|NCT00398918|Secondary|Score Digit Symbol Modalities Test|Difference score between zonisamide and placebo treatment conditions for the Digit Symbol Modalities Test scores obtained 40 minutes after ingestion of a priming dose of ethanol.This test involves transcribing from a key in which numbers appear below a series of symbols to boxes below symbols matched to those in the key. This task must be completed in 90 nseconds. This test measures visuomotor speed and aspects of attention. Scoring is the total number of correctly transcribed numbers. The maximum score on this test 110 points.|40 minutes post alcohol ingestion|ITT||Numeric Score||Standard Error|Mean
730958|NCT00398918|Primary|Grams Ethanol Consumed During Second Hour of the Alcohol Self-Administration Sessions|Grams Ethanol Consumed During Second Hour of the Alcohol Self-Administration Sessions for Zonisamide and Placebo Conditions|1 day|This was a laboratory based study. An ITT analysis was used.||Grams||Standard Error|Mean
730959|NCT00400569|Secondary|Number of Participants With Serious Adverse Events (SAEs)|Determine the number of participants who experience Serious Adverse events while on sunitinib malate study.|4 years, 7 months|All Participants||participants|||Number
730960|NCT00400569|Secondary|Participants' Overall Survival (OS)|The median OS times (months) for liposarcoma, leiomyosarcoma and MFH.|From On Treatment to Off Study - average of 6 months|All participants who completed the study||months||95% Confidence Interval|Median
730961|NCT00400569|Secondary|Participants' Progression Free Survival (PFS)|Time to tumor progression defined as the duration of time from start of treatment to time of progression. Response assessments were based on the longest diameter tumor measurements in accordance with Response Evaluation Criteria in Solid Tumors (RECIST).|From On Treatment to Off Study - average of 6 months|All participants who completed the study||months||95% Confidence Interval|Median
730962|NCT00400569|Primary|Number of Participants With Overall Response (OR)|Objective Radiographic Response Rate. Response assessments were based on the longest diameter tumor measurements in accordance with Response Evaluation Criteria in Solid Tumors (RECIST).|From On Treatment to Off Study - average of 6 months|All participants assessable for response||participants|||Number
730963|NCT00400634|Other Pre-specified|UPDRS Part III OFF|"The UPDRS (Unified Parkinson's Disease Rating Scale) is a clinical rating scale that assesses the symptomatic burden of Parkinson's Disease. The scale has four main sections, and each item is scored from a 0 to a 4 (higher number is more severe manifestation). Part III is a subsection devoted to motor function, has 14 questions, resulting in a score range of 0 (unaffected) to 56 (severely affected). The scale is administered by a trained clinician, and patients were assessed in a practically defined off condition, 12 hours or more after the last administration of medication."|Change from Baseline to 18 Month Visit|Subjects who completed the 12-month double-blind posttreatment period of the study continued to undergo double-blind assessments every 3 months until the last subject had completed the end-of-study visit at month 12. The LOCF method was used to impute data at month 18 for the subjects who had blinded data through month 15.||units on a scale||Standard Error|Least Squares Mean
730964|NCT00400634|Primary|UPDRS Part III OFF|"The UPDRS (Unified Parkinson's Disease Rating Scale) is a clinical rating scale that assesses the symptomatic burden of Parkinson's Disease. The scale has four main sections, and each item is scored from a 0 to a 4 (higher number is more severe manifestation). Part III is a subsection devoted to motor function, has 14 questions, resulting in a score range of 0 (unaffected) to 56 (severely affected). The scale is administered by a trained clinician, and patients were assessed in a practically defined off condition, 12 hours or more after the last administration of medication."|Change from Baseline to 12 Month Visit|Subjects who completed the end-of-study visit at month 12 and had no important protocol deviations that potentially could have affected the efficacy assessment of the study drug.||units on a scale||95% Confidence Interval|Least Squares Mean
730965|NCT00400686|Primary|Number of Patients With an at Least 2gm/dL Increase in Hgb||Baseline to Day 28|||participants|||Number
730966|NCT00400686|Primary|Number of Patients With an at Least 1gm/dL Increase in Hgb||Baseline to Day 28|||participants|||Number
730967|NCT00400686|Primary|Change From Baseline in Hemoglobin at Day 28|Change from baseline in hemoglobin after treatment with high-dose Epoetin Alfa.|Baseline to Day 28|||g/dL||Full Range|Median
730968|NCT00400712|Primary|Subjective Index of Physical Integration (Subscale of SIPSO)|see 'Subjective Index of Physical and Social Outcome (SIPSO) above|baseline and one year|those who completed 1 year testing||points on a scale||Standard Deviation|Mean
730969|NCT00400712|Primary|Subjective Index of Social Integration (Subscale of SIPSO)|see Subjective Index of Physical and Social Outcome (SIPSO) above|baseline and one year|those who completed 1 year testing||points on a scale||Standard Deviation|Mean
731044|NCT00401401|Primary|Adverse Events|Number of participants with at least one adverse event. All adverse events were collected during the 8 week treatment period and the following 4 weeks. Serious adverse events were collected during 3 years after the patient was allocated to the trial.|Overall Study|||participants|||Number
730970|NCT00400712|Secondary|Health-related Quality of Life - Mental|The SF-36 contains 36 questions pertaining to 8 health-related domains (physical and social function, emotional and physical limitation (role-emotional/role-physical), mental health, vitality, bodily pain, and general health). The derivation of the Mental component summary (MCS) score takes into account the mental health domains (social function, role-emotional and mental health) and scores self-reported mental health on a scale from 0 to 100, where 0 is the lowest rating of mental health and 100, the highest.|baseline and one year|those enrolled at 1 year (primary endpoint)||points||Standard Deviation|Mean
730971|NCT00400712|Secondary|Health-related Quality of Life - Physical|The SF-36 contains 36 questions pertaining to 8 health-related domains (physical and social function, emotional and physical limitation (role-emotional/role-physical), mental health, vitality, bodily pain, and general health). The derivation of the Physical component summary (PCS) score takes into account the physical health domains (physical function, role-physical and bodily pain) and scores self-reported physical health on a scale from 0 to 100, where 0 is the lowest rating of physical health and 100, the highest or best.|baseline and one year|those enrolled at primary endpoint (one year)||points||Standard Deviation|Mean
730972|NCT00400712|Secondary|Physical Capacity|6 minute walk test (6MWT). Subjects were instructed to walk as far as possible over 6 minutes with rests as needed and the distance traveled was recorded.|baseline and 12 months|all those enrolled at primary endpoint - 1 year||meters||Standard Deviation|Mean
730973|NCT00400712|Secondary|Mobility Function|Timed up and go - participants stand from a seated position on a chair with armrests, walk 3 meters, turn and return to a seated position (measured in seconds)|baseline and 1 year|those still enrolled at primary endpoint (one year)||seconds||Standard Deviation|Mean
730974|NCT00400712|Primary|Subjective Index of Physical and Social Outcome (SIPSO)|The SIPSO is a 10-item measure developed specifically for stroke that includes a Physical Integration Subscale relating to activities and daily living and a Social Integration subscale relating to social adaptation. Each item is assessed on an ordinal scale from 0 (cannot perform the task or activity/completely dissatisfied) to 4 (no difficultly/completely satisfied) such that the minimum score is 0 and the maximum for each subscale is 20 and the maximum total score is 40 (sum of subscales). The total score reflects reintegration.|baseline and 1 year|those who completed 1 year testing||scores on a scale||Standard Deviation|Mean
730975|NCT00400764|Primary|Mean Serum Concentration of Dulanermin|The dulanermin serum concentration was measured using enzyme linked immunosorbent assay (ELISA).|Blood samples were taken 0.5, 1.5, 2, 3, 5, 7 and 24 hours after the start of the infusion on Day 1 of Cycle 1.|Safety-evaluable population||µg/ml||Standard Deviation|Mean
730976|NCT00400764|Primary|Number of Participants With a Clinically Significant Laboratory Abnormality|Laboratory Parameters were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE). A clinically significant abnormality was defined as a Grade 3 (severe) or Grade 4 (very severe, life threatening, or disabling) laboratory toxicity according to the NCI CTCAE v3.0.|Baseline and Treatment Termination visit (8 weeks for Rituximab arm and 12 weeks for combination and Dulanermin arms).|Safety Evaluable population consisting of all randomized patients who received at least one dose of study drug.||participants|||Number
730977|NCT00400764|Primary|Vital Signs: Change From Baseline in Body Temperature at Treatment Termination Visit|Body temperature was measured at baseline and throughout the study. Change from baseline was calculated using the patients last recorded measurement at the completion of treatment visit - baseline measurement.|Baseline and Treatment Termination visit (8 weeks for Rituximab arm and 12 weeks for combination and Dulanermin arms)|Safety Evaluable population, consisting of all randomized patients who received at least one dose of treatment.||degrees Celsius||Standard Deviation|Mean
730978|NCT00400764|Secondary|Phase II: Duration of Response as Assessed by the Investigator|"An event was defined as documented disease progression or death on study, whichever occurred first. Duration of objective response was defined only for patients with an objective response as determined by the investigator and was the time from the initial response to disease progression or death on study.
Kaplan−Meier methods were used to estimate median, percentiles, and range of duration of response."|From Baseline through Study Termination (up to approximately 33 months)|Safety-evaluable patients with an objective response determined by the Investigator.||months||95% Confidence Interval|Median
730979|NCT00400764|Secondary|Phase II: Objective Response as Assessed by the Investigator|Objective response was defined as a confirmed or unconfirmed complete response(CR, CRu) or partial response (PR) assessed on the basis of clinical, radiographic (computed tomography (CT) scans of the neck, chest, abdomen, pelvis and inguinal region), and pathologic (i.e., bone marrow) criteria and according to the modified International Working Group (IWG) criteria. Patients without a post-baseline tumor assessment were considered non-responders.|From Baseline through Study Termination (up to approximately 33 months)|Safety Evaluable population, consisting of all randomized patients who received at least one dose of treatment.||participants|||Number
730980|NCT00400764|Secondary|Phase II: Overall Survival|Median overall survival could not be estimated because of the low number of deaths at the time of study termination.|From Baseline through Study Termination (up to approximately 33 months)|||months||95% Confidence Interval|Median
730981|NCT00400764|Secondary|Phase II: Progression Free Survival|Progression free survival (PFS) was defined as the time from randomization to documented disease progression or death, whichever occurred first and was based on the investigator's assessment using the modified IWG criteria. Kaplan−Meier methods were used to estimate median time to PFS. Data for patients without disease progression or death on study were censored at the time of the last tumor assessment.|From Baseline through Study Termination (up to approximately 33 months)|Safety-Evaluable population consisting of all randomized patients who received at least one dose of study treatment||months||95% Confidence Interval|Median
730982|NCT00400764|Primary|Vital Signs: Change From Baseline in Heart Rate at Treatment Termination Visit|Heart rate was measured at baseline and throughout the study. Change from baseline was calculated using the patient's last recorded measurement at the completion of treatment visit - baseline measurement.|Baseline and Treatment Termination visit (8 weeks for Rituximab arm and 12 weeks for combination and Dulanermin arms)|Safety Evaluable population, consisting of all randomized patients who received at least one dose of treatment.||beats/minute||Standard Deviation|Mean
731045|NCT00401414|Secondary|Proportion of Patients With Serious Adverse Clinical Events.|Defined as an INR>4.0, use of vitamin K, major bleeding events (as defined by the Thrombolysis in Myocardial Infarction [TIMI] criteria), thromboembolic events, stroke (all cause), myocardial infarction, and death (all cause).|90 Days|||participants|||Number
730983|NCT00400764|Primary|Vital Signs: Change From Baseline in Diastolic and Systolic Blood Pressure at Treatment Termination Visit|Blood pressure was measured at baseline and throughout the study. Change from baseline was calculated using the patient's last recorded measurement at the completion of treatment visit - baseline measurement.|Baseline and Treatment Termination visit (8 weeks for Rituximab arm and 12 weeks for combination and Dulanermin arms)|Safety Evaluable population, consisting of all randomized patients who received at least one dose of treatment.||mmHg||Standard Deviation|Mean
730984|NCT00400764|Primary|Phase II: Objective Response as Assessed by the Independent Review Facility (IRF)|"Objective response was defined as a confirmed or unconfirmed complete response (CR, CRu) or partial response (PR) assessed on the basis of clinical, radiographic (computed tomography (CT) scans of the neck, chest, abdomen, pelvis and inguinal region), and pathologic (i.e., bone marrow) criteria and according to the modified International Working Group (IWG) criteria. All radiographic and clinical data for the evaluation of objective response were submitted to an IRF for blinded and impartial assessment.
Patients without a post-baseline tumor assessment were considered non-responders."|From Baseline through Study Termination (up to approximately 33 months)|The phase II Efficacy-Evaluable population consisted of all randomized patients who received at least one dose of study treatment and had measurable disease at baseline, as assessed by the IRF.||participants|||Number
730985|NCT00400764|Primary|Number of Participants With Treatment-Emergent Adverse Events by Severity Grade|Safety was assessed through summaries of treatment-emergent adverse events (AEs); AEs were graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0, according to the following guidelines: Grade 1 (Mild); Grade 2 (Moderate); Grade 3 (Severe); Grade 4 (Life-threatening or disabling) and Grade 5 (Death related to AE).|From Baseline through Study Termination (up to a maximum of approximately 13 months for phase Ib and up to approximately 33 months for phase II)|Safety Evaluable population, consisting of all randomized patients who received at least one dose of treatment.||participants|||Number
730986|NCT00400764|Primary|Phase Ib: Number of Participants With a Dose-limiting Toxicity|A dose-limiting toxicity (DLT) was defined as a National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0 Grade ≥ 3 hematologic or major organ toxicity that was related to study drug (i.e., dulanermin). Although a patient may have experienced a DLT at any time during the study, only events that occurred within the DLT assessment window were considered for dose-escalation decisions and determination of the maximum tolerated dose (MTD).|The DLT assessment window was defined as the duration required to complete two full cycles of treatment with dulanermin (2 * 21 days) and four doses of rituximab (usually through Day 28).|The DLT-evaluable population consisted of all patients enrolled in the Phase Ib who received at least two complete cycles of dulanermin and four doses of rituximab and complete study assessments through the DLT Assessment Window without a DLT (usually through Day 28) or experienced a DLT and withdrew from the study within the DLT Assessment Window.||participants|||Number
730987|NCT00400803|Secondary|Time to Best Response|Time to best response is defined as the time from the start of treatment until first documented evidence of tumor response (30% decrease or complete disappearance of tumor). For subjects who do not show a tumor response, the time will be censored at the time of last contact.|From Enrollment to First Tumor Response|||Days||Full Range|Median
730988|NCT00400803|Secondary|Overall Survival Time|Overall survival is defined as the time from the start of treatment until death due to whatever cause. For subjects alive at study completion, time to death will be censored at the time of last contact.|Baseline to Death|||Months||Standard Error|Mean
730989|NCT00400803|Secondary|Duration of Response|For subjects who show a response, duration of response is defined to be the time from first documented evidence of response(30% decrease or complete disappearance of tumor) until the first documented sign of disease progression or death due to any cause. For subjects who do not progress or die, duration of response will be censored at the time of last tumor assessment.|From Enrollment through Date of First Documented Disease Progression or Date of Death From Any Cause, Whichever Came First, Up to 100 Months|||Days||Full Range|Median
730990|NCT00400803|Secondary|Best Overall Response by Cycle|Number of patients and their best response recorded from the state of treatment until disease progression. Response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST): Complete Response-disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that did not meet above criteria.|After Cycle 4, Cycle 6 and Cycle 7 of Therapy|For subjects who show a response, duration of response is defined to be the time from first documented evidence of response until the first documented sign of disease progression or death due to any cause. For subjects who do not progress or die, duration of response will be censored at the time of last tumor assessment. 5 patients = missing data.||Participants|||Number
730991|NCT00400803|Primary|Time to Progression|Time to progression (progression free survival)is defined as the time from the start of treatment until first documented sign of disease progression or death due to any cause. For subjects who do not progress, time to progression will be censored at the time of last tumor assessment.|From Enrollment Through 2 Years|||Months||Standard Error|Mean
730992|NCT00400829|Secondary|Progression Free Survival|Will be estimated using the product-limit method of Kaplan and Meier.|From start of treatment to the time of documented progression, assessed up to 5 years|||Months||95% Confidence Interval|Median
730993|NCT00400829|Secondary|Overall Survival|Will be estimated using the product-limit method of Kaplan and Meier.|From start of treatment to death from any cause, assessed up to 5 years|||Months||95% Confidence Interval|Median
730994|NCT00400829|Primary|Objective Response Rate (CR or PR) According to RECIST Criteria|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT, MRI or X-ray: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Tumor measurements repeated every 6 weeks|||percentage of patients responding|||Number
730995|NCT00400881|Secondary|Duration of Mechanical Ventilation|Duration in days from day of intubation to day of extubation.|days|Analysis per protocol. All patients completing the SBT were analysed except for two patients in each group that were excluded from analysis per protocol due to re-intubation due to upper airway obstruction.||days||Standard Deviation|Mean
731046|NCT00401414|Secondary|Time to Stable Anticoagulation (in Days).|Defined as two consecutive INRs within the therapeutic range >7 days apart and with no dose change during this time.|90 Days|||Days||Standard Deviation|Mean
730997|NCT00400946|Secondary|5-year Disease-Free Survival by CNS Directed Treatment Group|Disease-free survival (DFS) in a landmark analysis is defined as the duration of time from asparaginase randomization (which occurred after patients achieved complete remission and were assigned to a final risk group) to documented relapse, death during remission or second malignant neoplasm. DFS is estimated based on the Kaplan-Meier method and 5-year DFS is the probability of patients remaining alive, relapse-free and without occurrence of second malignant neoplasm 5 years from asparaginase randomization. Disease relapse is defined as >25% lymphoblasts identified morphologically in bone marrow aspirate/biopsy, or identification of lymphoblasts in marrow (any percentage) identified to be leukemic by flow cytometry, cytogenetics, FISH, immunohistochemistry, or other tests. Appearance of leukemic cells at any extramedullary site (a single, unequivocal lymphoblast in the CSF may qualify as CNS leukemia) also qualifies if confirmed by the PI.|Disease evaluations occurred continuously on treatment. Suggested long-term follow-up was monthly for 6m, bi-monthly for 6m, every 4 months for 1y, semi-annually for 1y, then annually. Median follow-up in this study cohort is 6 yrs, up to 10y.|The analysis dataset is comprised of patients who achieved an induction complete remission with an evaluable sample at diagnosis for analysis of CNS-directed therapy .||probability||95% Confidence Interval|Number
730998|NCT00400946|Secondary|5-Year Disease-Free Survival by Bone Marrow Day 18 Status|Disease-free survival (DFS) in a landmark analysis is defined as the duration of time from asparaginase randomization (which occurred after patients achieved complete remission and were assigned to a final risk group) to documented relapse, death during remission or second malignant neoplasm. DFS is estimated based on the Kaplan-Meier method and 5-year DFS is the probability of patients remaining alive, relapse-free and without occurrence of second malignant neoplasm 5 years from asparaginase randomization. Disease relapse is defined as >25% lymphoblasts identified morphologically in bone marrow aspirate/biopsy, or identification of lymphoblasts in marrow (any percentage) identified to be leukemic by flow cytometry, cytogenetics, FISH, immunohistochemistry, or other tests. Appearance of leukemic cells at any extramedullary site (a single, unequivocal lymphoblast in the CSF may qualify as CNS leukemia) also qualifies if confirmed by the PI.|Disease evaluations occurred continuously on treatment. Suggested long-term follow-up was monthly for 6m, bi-monthly for 6m, every 4 months for 1y, semi-annually for 1y, then annually. Median follow-up in this study cohort is 6 yrs, up to 10y.|The analysis dataset is comprised of patients who achieved an induction complete remission with an evaluable sample at day 18 (optional submission) for analysis of marrow morphology.||probability||95% Confidence Interval|Number
730999|NCT00400946|Secondary|5-Year Disease-Free Survival by MRD Day 32 Status|Disease-free survival (DFS) in a landmark analysis is defined as the duration of time from asparaginase randomization (which occurred after patients achieved complete remission and were assigned to a final risk group) to documented relapse, death during remission or second malignant neoplasm. DFS is estimated based on the Kaplan-Meier method and 5-year DFS is the probability of patients remaining alive, relapse-free and without occurrence of second malignant neoplasm 5 years from asparaginase randomization. Disease relapse is defined as >25% lymphoblasts identified morphologically in bone marrow aspirate/biopsy, or identification of lymphoblasts in marrow (any percentage) identified to be leukemic by flow cytometry, cytogenetics, FISH, immunohistochemistry, or other tests. Appearance of leukemic cells at any extramedullary site (a single, unequivocal lymphoblast in the CSF may qualify as CNS leukemia) also qualifies if confirmed by the PI.|Disease evaluations occurred continuously on treatment. Suggested long-term follow-up was monthly for 6m, bi-monthly for 6m, every 4 months for 1y, semi-annually for 1y, then annually. Median follow-up in this study cohort is 6 yrs, up to 10y.|The analysis dataset is comprised of B cell ALL patients who achieved an induction complete remission with an evaluable sample at day 32 for analysis of MRD.||probability||95% Confidence Interval|Number
731000|NCT00400946|Secondary|Induction Therapeutic Nadir Serum Asparaginase Activity Rate|Nadir serum asparaginase activity (NSAA) levels were estimated based on established methods. Induction therapeutic NSAA rate is defined as the percentage of patients achieving a NSAA level above 0.1 IU/mL at a given timepoint.|Samples for serum asparaginase activity analyses were obtained days 4, 11, 18 and 25 post one-dose of IV-PEG on day 7 of the induction phase.|The analysis dataset is comprised of all randomized patients who consented to research studies with an evaluable sample for analysis of serum asparaginase activity at the respective induction assessment timepoints.||percentage of participants|||Number
731001|NCT00400946|Secondary|Induction Serum Asparaginase Activity Level|Serum asparaginase activity (NSAA) levels were estimated based on established methods.|Samples for serum asparaginase activity analyses were obtained days 4, 11, 18 and 25 post one-dose of IV-PEG on day 7 of the induction phase.|The analysis dataset is comprised of all randomized patients who consented to research studies with an evaluable sample for analysis of serum asparaginase activity at the respective induction assessment timepoints.||IU/mL||Inter-Quartile Range|Median
731002|NCT00400946|Secondary|Induction Infection Toxicity Rate|Infection toxicity rate is defined as the percentage of patients who experience bacterial or fungal infection of grade 3 or higher with treatment attribution of possibly, probably or definite based on CTCAEv3 during remission induction phase of combination chemotherapy.|Assessed daily during remission induction days 4-32.|The analysis dataset is comprised of eligible and treated patients. This excludes the 6 enrolled but ineligible patients. Rates in this overall study cohort will be compared against historical controls (in particular patients treated with a more intensive induction regimen).||percentage of participants||95% Confidence Interval|Number
731003|NCT00400946|Secondary|Post-Induction Therapeutic Nadir Serum Asparaginase Activity Rate|Nadir serum asparaginase activity (NSAA) levels were estimated based on established methods. Post-Induction therapeutic NSAA rate is defined as the percentage of patients achieving a NSAA level above 0.1 IU/mL ever during post-induction therapy.|Samples for nadir serum asparaginase activity analyses were obtained before doses administered at weeks 5, 11, 17, 23 and 29 of post-induction asparaginase treatment.|The analysis dataset is comprised of all randomized patients who consented to research studies with a one post-induction evaluable sample for analysis of serum asparaginase activity.||percentage of participants||95% Confidence Interval|Number
731004|NCT00400946|Secondary|Post-Induction Nadir Serum Asparaginase Activity Level|Nadir serum asparaginase activity (NSAA) levels were estimated based on established methods.|Samples for nadir serum asparaginase activity analyses were obtained before doses administered at weeks 5, 11, 17, 23 and 29 of post-induction asparaginase treatment.|The analysis dataset is comprised of all randomized patients who consented to research studies with an evaluable sample for analysis of serum asparaginase activity at the respective post-induction assessment timepoints.||IU/mL||Standard Deviation|Mean
731005|NCT00400946|Secondary|5-Year Disease-Free Survival|Disease-free survival (DFS) in a landmark analysis is defined as the duration of time from asparaginase randomization (which occurred after patients achieved complete remission and were assigned to a final risk group) to documented relapse, death during remission or second malignant neoplasm. DFS is estimated based on the Kaplan-Meier method and 5-year DFS is the probability of patients remaining alive, relapse-free and without occurrence of second malignant neoplasm 5 years from asparaginase randomization. Disease relapse is defined as >25% lymphoblasts identified morphologically in bone marrow aspirate/biopsy, or identification of lymphoblasts in marrow (any percentage) identified to be leukemic by flow cytometry, cytogenetics, FISH, immunohistochemistry, or other tests. Appearance of leukemic cells at any extramedullary site (a single, unequivocal lymphoblast in the CSF may qualify as CNS leukemia) also qualifies if confirmed by the PI.|Disease evaluations occurred continuously on treatment. Suggested long-term follow-up was monthly for 6m, bi-monthly for 6m, every 4 months for 1y, semi-annually for 1y, then annually. Median follow-up in this study cohort is 6 yrs, up to 10y.|The analysis dataset is comprised of all randomized patients.||probability||95% Confidence Interval|Number
731006|NCT00400946|Primary|Asparaginase-Related Toxicity Rate|Asparaginase-related toxicity rate is defined as the percentage of patients who experience allergy (all grades), symptomatic pancreatitis (grade 2 or worse), thrombotic or bleeding complications requiring intervention (grade 2 or worse) with treatment attribution of possibly, probably or definite based on CTCAEv3.|30-week post-induction asparaginase treatment period|The analysis dataset is comprised of all randomized patients.||percentage of participants||95% Confidence Interval|Number
731007|NCT00401102|Secondary|Multidimensional Anxiety Scale for Children||recently||||||
731008|NCT00401102|Secondary|Beck Depression Inventory||2 weeks||||||
731009|NCT00401102|Primary|Self-injury Monitoring Card||1 month||||||
731010|NCT00401102|Primary|Self-Injurious Thoughts and Behaviors Interview||8 weeks|Data for all subjects who completed the study was examined - however because this was a small pilot study and only 5 subjects completed treatment, no statistical tests were completed.||episodes of self-injury past month||Standard Deviation|Mean
731011|NCT00401102|Primary|CDRS||1 week||||||
731012|NCT00401102|Primary|C-GAS||1 month||||||
731013|NCT00401102|Primary|CGI||1 week||||||
731014|NCT00401193|Secondary|Responder Analysis - Reduction in Large Stains|Percentage of subjects who experienced a reduction from baseline in the frequency of large stains|Baseline over 3 mentrual cycles|modified intent to treat population (reflects those subjects who met the criteria for the primary efficacy analysis)||percentage of participants|||Number
731015|NCT00401193|Secondary|Patient Reported Outome Measure of Limitations in Physical Activities Associated With Heavy Menstrual Bleeding|A positive unit change of the mean relects an improvement from baseline. Patient reported outcome scores had the following response categories: 1=not limited at all; 2=slightly limited; 3=moderately limited; 4=quite a bit limited; and 5=extremely limited|Baseline scores over 3 menstrual cycles|modified intent to treat population (reflects those subjects who met the criteria for the primary efficacy analysis)||units on a scale||Standard Deviation|Least Squares Mean
731016|NCT00401193|Secondary|Patient Reported Outcome Measure of Limitations in Social or Leisure Activities Associated With Heavy Menstrual Bleeding|A positive unit change of the mean relects an improvement from baseline. Patient reported outcome scores had the following response categories: 1=not limited at all; 2=slightly limited; 3=moderately limited; 4=quite a bit limited; and 5=extremely limited|Baseline scores over 3 menstrual cycles|modified intent to treat population (reflects those subjects who met the criteria for the primary efficacy analysis)||units on a scale||Standard Deviation|Least Squares Mean
731017|NCT00401193|Primary|Mean Reduction From Baseline in Menstrual Blood Loss (MBL)|reduction of menstrual blood loss in mL|Baseline MBL over 3 menstrual cycles|modified intent to treat population||mL||Standard Deviation|Least Squares Mean
731018|NCT00401245|Other Pre-specified|Gender of the Participants in Tapering Phase|Participants were re-randomized to tapering phase after OL phase.|Week 17|The tapering population included all participants who had completed at least 6 weeks of treatment and taken at least 1 dose of double-blind test article during the tapering phase.||Participants|||Number
731019|NCT00401245|Other Pre-specified|Mean Age of the Participants in Tapering Phase|Participants were re-randomized to tapering phase after OL phase.|Week 17|The tapering population included all participants who had completed at least 6 weeks of treatment and taken at least 1 dose of double-blind test article during the tapering phase.||Years||Standard Deviation|Mean
731020|NCT00401245|Secondary|Change From Baseline in Menopause-specific Quality of Life Questionnaire (MenQOL) Score at Week 4, Week 8, Week 12 and Week 16|MenQOL questionnaire assessed how bothered participants were with 31 symptoms. It contains domains: vasomotor (items 1-3); psychosocial (items 4-10); physical (items 11-26); sexual (items 27-29); in addition to nausea and indigestion. 31 individual symptoms are rated on a scale of 0 (not at all bothered) to 6 (extremely bothered). Total possible score ranged from 0 to 186. MenQOL summary score was calculated as mean of four domain scores (Physical function, Psychosocial function, Sexual function and Vasomotor function) ranging from 1 to 8, with higher scores indicating worse quality of life.|Baseline, Week 4, Week 8, Week 12 and Week 16|The OL population included all participants who had taken at least 1 dose of open label test article. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time points for each group respectively.||Units on a scale||Standard Deviation|Mean
731021|NCT00401245|Secondary|Menopause Symptoms-treatment Satisfaction Questionnaire (MS-TSQ) Score|MS-TSQ is a questionnaire assessing participants’ degree of satisfaction with regard to the test article which was administered to the participants via an IVRS/IWRS. The questionnaire comprised 8 questions and each was rated on a scale from 0 (extremely dissatisfied) to 4 (extremely satisfied).|Week 16|The OL population included all participants who had taken at least 1 dose of open label test article. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure at the specified time point for each group respectively.||Units on a scale||Standard Deviation|Mean
731042|NCT00401401|Secondary|Time to Response|Tumour response according to RECIST criteria J Natl Cancer Inst 2000;92:205-16 assessed by CT/MRI. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the longest diameter of target lesions; Overall Response (OR), CR+PR|Up to 3 years|Number of months between date of first infusion and date of best response||months||Full Range|Median
731022|NCT00401245|Secondary|Number of Participants Showing Satisfaction With Tolerability at the End of Tapering|Satisfaction with tolerability (lack of bothersomeness) was assessed using a questionnaire via an IVRS/IWRS and evaluated based on participants’ response of extremely satisfied, satisfied, neutral, dissatisfied or extremely dissatisfied with the study medication.|Week 19|Tapering population included all participants who had completed at least 6 weeks of treatment and taken at least 1 dose of double-blind test article during the tapering phase. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure at the specified time point for each group respectively.||Participants|||Number
731023|NCT00401245|Secondary|Number of Participants Showing Satisfaction With Tolerability During the First Two Weeks of Treatment|Satisfaction with tolerability (lack of bothersomeness) was assessed using a questionnaire via an interactive voice response system (IVRS)/interactive web based response system (IWRS), and evaluated based on participants’ response of extremely satisfied, satisfied, neutral, dissatisfied or extremely dissatisfied with the study medication.|Week 1 and Week 2|The titration population included all randomly assigned participants who had taken at least 1 dose of double-blind test article during the double-blind titration period. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time points for each group respectively.||Participants|||Number
731024|NCT00401245|Secondary|Number of Participants With Each DESS One Week After End of Tapering|DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article.|Week 19|Tapering population included all participants who had completed at least 6 weeks of treatment and taken at least 1 dose of double-blind test article during the tapering phase. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure at the specified time point for each group respectively.||Participants|||Number
731025|NCT00401245|Secondary|Number of Participants With Each DESS at the End of Second Week of Tapering|DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article.|Week 18|Tapering population included all participants who had completed at least 6 weeks of treatment and taken at least 1 dose of double-blind test article during the tapering phase. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure at the specified time point for each group respectively.||Participants|||Number
731026|NCT00401245|Secondary|Number of Participants With Each DESS at the End of First Week of Tapering|DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article.|Week 17|The tapering population included all participants who had completed at least 6 weeks of treatment and taken at least 1 dose of double-blind test article during the tapering phase.||Participants|||Number
731027|NCT00401245|Secondary|Percentage of Participants Discontinuing Treatment Due to AEs in First 2 Weeks of Treatment|Any untoward medical occurrence in a participant who received study drug was considered an AE, without regard to possibility of causal relationship.|Baseline up to Week 2|The titration population included all randomly assigned participants who had taken at least 1 dose of double-blind test article during the double-blind titration period.||Percentage of participants|||Number
731028|NCT00401245|Secondary|Number of Participants With Other Spontaneously Reported Adverse Events (AEs) in First 2 Weeks of Treatment|Any untoward medical occurrence in a participant who received study drug was considered an AE, without regard to possibility of causal relationship.|Baseline up to Week 2|The titration population included all randomly assigned participants who had taken at least 1 dose of double-blind test article during the double-blind titration period.||Participants|||Number
731029|NCT00401245|Primary|DESS Total Score at 1 Week After the End of Tapering|"DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of new symptoms and old (but worse) symptoms (1) and 0 for old and unchanged symptom, absent, or old symptom but improved for a total possible range of 0 to 43. A higher score indicates more symptoms."|Week 19|Tapering population included all participants who had completed at least 6 weeks of treatment and taken at least 1 dose of double-blind test article during the tapering phase. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure at the specified time point for each group respectively.||Units on a scale||Standard Deviation|Mean
731030|NCT00401245|Primary|DESS Total Score at End of Second Week of Tapering|"DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of new symptoms and old (but worse) symptoms (1) and 0 for old and unchanged symptom, absent, or old symptom but improved for a total possible range of 0 to 43. A higher score indicates more symptoms."|Week 18|Tapering population included all participants who had completed at least 6 weeks of treatment and taken at least 1 dose of double-blind test article during the tapering phase. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure at the specified time point for each group respectively.||Units on a scale||Standard Deviation|Mean
731031|NCT00401245|Primary|Discontinuation Emergent Signs and Symptoms (DESS) Total Score at the End of First Week of Tapering|"DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of new symptoms and old (but worse) symptoms (1) and 0 for old and unchanged symptom, absent, or old symptom but improved for a total possible range of 0 to 43. A higher score indicates more symptoms."|Week 17|The tapering population included all participants who had completed at least 6 weeks of treatment and taken at least 1 dose of double-blind test article during the tapering phase.||Units on a scale||Standard Deviation|Mean
731032|NCT00401245|Primary|Number of Participants With Nausea During the First 2 Weeks of Treatment|Nausea by spontaneous reports to the investigators was counted if it was reported during first 2 weeks of treatment, and it was not seen before the first dose of treatment, or if it was seen before the first dose and the symptoms got worse. If multiple incidences occurred on the same participant during the 2 weeks, only 1 incidence was counted.|Baseline up to Week 2|The titration population included all randomly assigned participants who had taken at least 1 dose of double-blind test article during the double-blind titration period.||Participants|||Number
731033|NCT00401258|Secondary|Sheehan Disability Scale||At each visit||||||
731034|NCT00401258|Secondary|Irritable Bowel Syndrome-Quality of Life Scale||At each visit||||||
731049|NCT00401414|Primary|Mean Percentage of Time That INR Within Therapeutic Range Using Linear Interpolation (Rosendaal et al).|"Primary end point: mean percentage of time INR is within therapeutic range. Though target INR was 2.0-3.0, therapeutic INR is considered 1.8-3.2 (allows for INR measurement error and avoids problems inherent in overcorrection).
The international normalized ratio (INR) is one way of presenting prothrombin time test results for people taking the blood-thinning medication warfarin. The INR formula adjusts for variation in laboratory testing methods so that test results can be comparable."|90 Days|||percentage of time||Standard Deviation|Mean
731050|NCT00401531|Secondary|Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™|"Solicited Injection Site Reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Pyrexia, Vomiting, Crying, Somnolence, Anorexia, and Irritability Grade 3: Pain, cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, ≥5 cm.
Grade 3: Pyrexia, >39°C; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying, >3 hours; Somnolence, Sleeping most of the time or difficult to wake up; Anorexia, Refuses ≥3 feeds/meals or refuses most feeds/meals; and Irritability, Inconsolable."|Day 0 up to Day 7 post-vaccination|Solicited reactions were assessed in all participants that were enrolled and vaccinated, intent-to-treat population.||Participants|||Number
731051|NCT00401531|Secondary|Geometric Mean Titers (GMTs) of Vaccine Antibodies Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™|Anti-hepatitis B antibodies were measured using chemiluminescence detection technology. Anti-Haemophilus influenzae type b (anti-PRP) antibodies were measured by radioimmunoassay, anti-Diphtheria by toxin neutralization assay, anti-Tetanus and anti-Pertussis by enzyme-linked immunosorbent assay (ELISA), and anti-Polio by neutralization assay.|Day 150 post-dose 1|Antibody titers were assessed in participants who had not committed any protocol violation that could have interfered with the primary criteria evaluation, the per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
731052|NCT00401531|Secondary|Number of Participants With Seroconversion Against Pertussis Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™|Anti pertussis toxoid (PT) and anti-filamentous hemagglutinin (FHA) antibodies were measured by enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as ≥ 4 fold increase over baseline.|Day 150 post-dose 1|Seroconversion was assessed in participants who had not committed any protocol violation that could have interfered with the primary criteria evaluation per-protocol population.||Participants|||Number
731053|NCT00401531|Secondary|Number of Participants With Seroprotection Against Poliovirus Types 1, 2, and 3 Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™|Anti poliovirus types 1, 2, and 3 antibodies were measured by neutralization assay. Seroprotection was defined as a titer ≥ 8 1/dil|Day 150 post-dose 1|Seroprotection was assessed in participants who had not committed any protocol violation that could have interfered with the primary criteria evaluation, per-protocol population.||Participants|||Number
731054|NCT00401531|Secondary|Number of Participants With Seroprotection Against Diphtheria and Tetanus Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™|Anti-Diphtheria antibodies were measured by a toxin neutralization test. Anti-Tetanus antibodies were measured by an indirect enzyme-linked immunosorbent assay (ELISA). Seroprotection was defined for both as a titer ≥ 0.01 IU/mL.|Day 150 post-dose 1|Seroprotection was assessed in the participants who had not committed any protocol violation that could have interfered with the primary criteria valuation, per-protocol population.||Participants|||Number
731055|NCT00401531|Primary|Number of Participants Achieving Seroprotection Against Hepatitis B and Haemophilus Influenzae Type b Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™|Anti-Hepatitis B antibodies were measured using chemiluminescence detection technology; seroprotection was defined as a titer ≥ 10 mIU/mL. Anti-Haemophilus influenzae type b (anti-PRP) antibodies were measured by radioimmunoassay; seroprotection was defined as a titer ≥ 0.15 µg/mL.|Day 150 post-dose 1|Seroprotection was assessed in the participants who had not committed any protocol violation that could have interfered with the primary criteria evaluation, per-protocol population.||Participants|||Number
731056|NCT00401544|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy (FACT) - Fatigue Score, by IV Iron Usage|Health related quality of life was measured using the Functional Assessment of Cancer Therapy (FACT) - Fatigue subscale. The FACT-F includes 13 fatigue items, with each item assessed on a 5-point scale (ie, response values of 0 to 4). The FACT-F subscale score ranges from 0 to 52, where a higher score represents less fatigue.|Baseline and Week 16|Patient-Reported Outcomes (PRO) Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug, and who completed at least one baseline and one post-baseline PRO assessment.||Units on a scale||Standard Deviation|Mean
731057|NCT00401544|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy (FACT) - Fatigue Score, by Darbepoetin Alfa Dose|Health related quality of life was measured using the Functional Assessment of Cancer Therapy (FACT) - Fatigue subscale. The FACT-F includes 13 fatigue items, with each item assessed on a 5-point scale (ie, response values of 0 to 4). The FACT-F subscale score ranges from 0 to 52, where a higher score represents less fatigue.|Baseline and Week 16|Patient-Reported Outcomes (PRO) Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug, and who completed at least one baseline and one post-baseline PRO assessment.||Units on a scale||Standard Deviation|Mean
731058|NCT00401544|Secondary|Time to Hematopoietic Response, by IV Iron Usage|The time to hematopoietic response is the interval in weeks between study day 1 and the first day that a hematopoietic response is observed during the treatment period. Hematopoietic response is defined as an increase in hemoglobin concentration of ≥ 2.0 g/dL from baseline or a hemoglobin concentration ≥ 12.0 g/dL in the absence of RBC transfusions on the day of measurement and during the preceding 28 days of the treatment period. If a participant did not achieve a hematopoietic response by the time of withdrawal or the end of the treatment period (EOTP), the time to hematopoietic response was censored on the day of the last hemoglobin measurement or the EOTP, whichever was earlier. Median was calculated using using Kaplan-Meier estimates.|From Week 1 to Week 16|Subset of Primary Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug, who had a baseline hemoglobin value.||Weeks||95% Confidence Interval|Median
731059|NCT00401544|Secondary|Time to Hematopoietic Response, by Darbepoetin Alfa Dose|The time to hematopoietic response is the interval in weeks between study day 1 and the first day that a hematopoietic response is observed during the treatment period. Hematopoietic response is defined as an increase in hemoglobin concentration of ≥ 2.0 g/dL from baseline or a hemoglobin concentration ≥ 12.0 g/dL in the absence of RBC transfusions on the day of measurement and during the preceding 28 days of the treatment period. If a participant did not achieve a hematopoietic response by the time of withdrawal or the end of the treatment period (EOTP), the time to hematopoietic response was censored on the day of the last hemoglobin measurement or the EOTP, whichever was earlier. Median was calculated using using Kaplan-Meier estimates.|From Week 1 to Week 16|Subset of Primary Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug, who had a baseline hemoglobin value.||Weeks||95% Confidence Interval|Median
731060|NCT00401544|Secondary|Number of Participants With a Hematopoietic Response, by IV Iron Usage|Number of participants with a hematopoietic response, defined as > 2 g/dL increase from baseline or hemoglobin ≥ 12 g/dL during the treatment period in the absence of a red blood cell transfusion within the prior 28 days. Assessing the effect of iron in a factorial experiment.|From Week 1 to Week 16|Subset of Primary Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug, who had a baseline hemoglobin value.||Participants|||Number
731061|NCT00401544|Secondary|Number of Participants With a Hematopoietic Response, by Darbepoetin Alfa Dose|Number of participants with a hematopoietic response, defined as > 2 g/dL increase from baseline or hemoglobin ≥ 12 g/dL during the treatment period in the absence of a red blood cell transfusion within the prior 28 days.|From Week 1 to Week 16|Subset of Primary Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug, who had a baseline hemoglobin value.||Participants|||Number
731062|NCT00401544|Secondary|Number of Participants With ≥ 1 Red Blood Cell Transfusion From Week 5 to End of Study|Number of participants with ≥ 1 RBC transfusion from Week 5 to end of study (Week 16)). Participants with a hemoglobin value ≤ 8 g/dL but no RBC transfusion were counted as having had a transfusion.|From Week 5 to Week 16|Subset of Primary Analysis Set, composed of all randomized participants who received at least one dose of blinded study medication, and who were eligible for an RBC transfusion at week 5.||Participants|||Number
731063|NCT00401544|Secondary|Number of Participants With ≥ 1 Red Blood Cell Transfusion From Week 1 to End of Study, by IV Iron Usage|The number of participants with ≥ 1 red blood cell (RBC) transfusion from week 1 to end of study (EOS). Participants with a hemoglobin value ≤ 8 g/dL but no RBC transfusion were counted as having had a transfusion.|From Week 1 to Week 16|Primary Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug.||Participants|||Number
731064|NCT00401544|Secondary|Number of Participants With ≥ 1 Red Blood Cell Transfusion From Week 1 to End of Study, by Darbepoetin Alfa Dose|The number of participants with ≥ 1 red blood cell (RBC) transfusion from week 1 to end of study (EOS). Participants with a hemoglobin value ≤ 8 g/dL but no RBC transfusion were counted as having had a transfusion.|From Week 1 to Week 16|Primary Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug.||Participants|||Number
731065|NCT00401544|Secondary|Change From Baseline in Hemoglobin Concentration, by IV Iron Usage|Change in hemoglobin concentration from Baseline to the end of the treatment period (Week 16).|Baseline and Week 16|Primary Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug. Imputation by last value carried forward (LVCF) was applied.||g/dL||Standard Deviation|Mean
731066|NCT00401544|Secondary|Change From Baseline in Hemoglobin Concentration, by Darbepoetin Alfa Dose|Change in hemoglobin concentration from Baseline to the end of the treatment period (Week 16).|Baseline and Week 16|Primary Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug. Imputation by last value carried forward (LVCF) was applied.||g/dL||Standard Deviation|Mean
731067|NCT00401544|Secondary|Time to Achieve the Target Hemoglobin Level, by IV Iron Usage|The time to target hemoglobin is the interval in weeks between study day 1 and the first day that a hemoglobin value ≥ 11.0 g/dL is observed during the treatment period. If a participant did not achieve the target hemoglobin by the time of withdrawal or the end of the treatment period (EOTP), the time to target hemoglobin was censored on the day of the last hemoglobin measurement or the EOTP, whichever was earlier. Median was calculated using Kaplan-Meier estimates.|From Week 1 to Week 16|Subset of Primary Analysis Set, composed of all randomized participants who received at least one dose of blinded study medication, who had baseline hemoglobin values < 11.0 g/dL.||Weeks||95% Confidence Interval|Median
731068|NCT00401544|Secondary|Time to Achieve Target Hemoglobin Level, by Darbepoetin Alfa Dose|The time to target hemoglobin is the interval in weeks between study day 1 and the first day that a hemoglobin value ≥ 11.0 g/dL is observed during the treatment period. If a participant did not achieve the target hemoglobin by the time of withdrawal or the end of the treatment period (EOTP), the time to target hemoglobin was censored on the day of the last hemoglobin measurement or the EOTP, whichever was earlier. Median was calculated using Kaplan-Meier estimates.|From Week 1 to Week 16|Subset of Primary Analysis Set, composed of all randomized participants who received at least one dose of blinded study medication, who had baseline hemoglobin values < 11.0 g/dL.||Weeks||95% Confidence Interval|Median
731069|NCT00401544|Primary|Number of Participants Who Achieved the Target Hemoglobin Levels, by IV Iron Usage|Target hemoglobin was defined as ≥ 11 g/dL during the treatment period in the absence of a red blood cell (RBC) transfusion on the day of measurement or during the preceding 28 days.|From Week 1 to Week 16|Subset of Primary Analysis Set, composed of all randomized participants who received at least one dose of blinded study medication, who had baseline hemoglobin values < 11.0 g/dL.||Participants|||Number
731070|NCT00401544|Primary|Number of Participants Who Achieved the Target Hemoglobin Level, by Darbepoetin Alfa Dose|Target hemoglobin was defined as ≥ 11 g/dL during the treatment period in the absence of a red blood cell (RBC) transfusion on the day of measurement or during the preceding 28 days.|From Week 1 to Week 16|Subset of Primary Analysis Set, composed of all randomized participants who received at least one dose of blinded study medication, who had baseline hemoglobin values < 11.0 g/dL.||Participants|||Number
731073|NCT00401726|Secondary|Number of Patients by Clinical Global Improvement - Global Improvement Score at 16 Weeks|CGI-I is a global rating scale that measures disease improvement. Using a 7-point scale, the clinician rates how much the patient’s illness has improved or worsened relative to the baseline status (1=very much improved, 7=very much worse).|112 days|The analysis population was the Modified Intent to Treat population, which included all patients who received a prescription and had at least 1 post-baseline efficacy evaluation; last observation carried forward. Data not available for one participant.||patients|||Number
731074|NCT00401726|Secondary|Change in Sheehan Disability Scale Score From Baseline to 16 Weeks|The Sheehan Disability Scale is a self-administered tool that measures functional impairment in 3 domains: Work/School, Social Life and Family Life/Home Responsibilities. The patient rates the extent to which each of these domains are impaired by his/her symptoms using a 10 point visual analog scale: (0=not at all impaired and 10=extremely impaired) for a total maximum score of 30.|Baseline and 112 days|The analysis population was the Modified Intent to Treat population, which included all patients who received a prescription and had at least 1 post-baseline efficacy evaluation; last observation carried forward.||units on scale||Standard Error|Mean
731075|NCT00401726|Secondary|Change in Inventory of Depressive Symptomatology - Self-Report (IDS-SR) Score From Baseline to 16 Weeks|IDS-SR is a patient self-administered tool used to measure the severity of depressive symptoms. Each symptom is assessed on a scale of 0 to 3 (0=absence of symptom to 3=sever symptom) for a total maximum score of 84.|Baseline and 112 days|The analysis population was the Modified Intent to Treat population, which included all patients who received a prescription and had at least 1 post-baseline efficacy evaluation; last observation carried forward.||units on scale||Standard Error|Mean
731076|NCT00401726|Secondary|Number of Patients Compliant With Therapy|Patient compliance with therapy was assessed using a Medical Adherence Questionnaire (MAQ). MAQ consisted of 5 levels of compliance with taking medicine: Never miss, Sometimes miss, Miss half of the time, Miss most of the time, Always miss. Compliance with therapy was defined as a response of “Never miss” or “Sometimes miss”.|112 days|The analysis population was the Modified Intent to Treat population, which included all patients who received a prescription and had at least 1 post-baseline efficacy evaluation; last observation carried forward.||participants|||Number
731077|NCT00401726|Secondary|Change in WHO 5-item Well Being Index Score From Baseline to 16 Weeks|WHO 5-item Well Being Index (WHO-5) evaluates positive psychological well-being. WHO-5 consists of 5 questions and each is rated on a 6-point scale. The total score ranges from 0 to 25 (0=worst possible quality of life, 25=best possible quality of life). Change = 16 week adjusted mean WHO-5 score minus baseline.|Baseline and 112 days|The analysis population was the Modified Intent to Treat population, which included all patients who received a prescription and had at least 1 post-baseline efficacy evaluation; last observation carried forward.||units on scale||Standard Error|Mean
731078|NCT00401726|Secondary|Patient Global Impression of Improvement (PGI-I) Score|PGI-I is a global rating scale that measures disease improvement. Using a 7-point scale (1=very much improved, 7=very much worse), the patients rate how much their illness has improved or worsened relative to their baseline status.|112 days|The analysis population was the Modified Intent to Treat population, which included all patients who received a prescription and had at least 1 post-baseline efficacy evaluation; last observation carried forward.||units on scale||Standard Error|Mean
731079|NCT00401726|Secondary|Change in 17-item Hamilton Depression Scale Score From Baseline to 16 Weeks|HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2 or 4 scale (0 = none/absent and 4 = most severe) with a maximum total score of 50. Change = 16 week adjusted mean HAM-D17 score minus baseline.|Baseline and 112 days|The analysis population was the Modified Intent to Treat population, which included all patients who received a prescription and had at least 1 post-baseline efficacy evaluation; last observation carried forward.||units on scale||Standard Error|Mean
731080|NCT00401726|Primary|Number of Patients Responding “Very Satisfied” on Satisfaction With Depression Care Scale (SDCS)|Patient satisfaction with depression care treatment was evaluated by patient self-assessment using the SDCS, a 10-point visual analog scale (0=not at all satisfied, 10=extremely satisfied). “Very satisfied” was defined as a score of greater than or equal to 8.|112 days|The analysis population was the Modified Intent to Treat population, which included all patients who received a prescription and had at least 1 post-baseline efficacy evaluation; last observation carried forward.||participants|||Number
731081|NCT00401752|Secondary|The Percentage of Participants Whose GU(s) and DU(s) in Combination Were Healed at Week 4 and Week 8 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily NSAID Therapy|Healed was defined as the absence of ulcers (Ulcers were on S stage or absent). It was calculated as the proportion of subjects whose gastric and duodenal ulcer healed after 4 and 8 weeks treatment.|4 & 8 weeks|||Percentage of participants|||Number
731082|NCT00401752|Secondary|The Percentage of Participants Whose Duodenal Ulcer(s) (DUs) Was (Were) Healed at Week 4 and Week 8 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily NSAID Therapy.|Healed was defined as the absence of ulcers (Ulcers were on S stage or absent). It was calculated as the proportion of subjects whose duodenal ulcer healed after 4 and 8 weeks treatment.|4 and 8 week|||Percentage of participants|||Number
731083|NCT00401752|Secondary|Percentage of Participants With the Occurance of Any Adverse Event.|Safety evaluation including vital signs, physical examination, ECG, adverse events and clinical laboratory evaluations during 8 weeks treatment.|8 weeks|Patients included in safety population||Percentage of participants|||Number
731084|NCT00401752|Secondary|The Resolution of Heartburn Symptoms at Week 4 and Week 8 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily NSAID Therapy.|Resolution rate of investigator-assessed GI symptoms, including heartburn, acid regurgitation, nausea, abdominal fullness and sleep disorder. It was calculated as the percentage of subjects whose heartburn symptoms were resolved at Week 8.|week 4 and week 8|||Percentage of participants|||Number
731085|NCT00401752|Secondary|The Percentage of Subjects Whose Gastric Ulcer(s) Was (Were) Healed at Week 8 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily NSAID Therapy.|Healed was defined as the absence of gastric ulcers (Ulcers were on S stage or absent). It was calculated as the proportion of subjects whose gastric ulcer(s) healed after 8 weeks treatment.|8 weeks|||Percentage of participants|||Number
731086|NCT00401752|Primary|The Percentage of Subjects Whose Gastric Ulcer(s) (GUs) Was (Were) Healed at Week 4 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily Non-steroidal Anti-inflammatory Drug (NSAID)Therapy.|"Healed was defined as the absence of gastric ulcers. It was calculated as the proportion of subjects whose gastric ulcer(s) healed after 4 weeks treatment.
(Ulcers were on S stage, stage 1 = Nonblanchable erythema of intact skin, stage 2 = Partial thickness skin loss involving epidermis, dermis, or both, stage 3 = Full thickness skin loss involving damage to or necrosis of subcutaneous tissue, stage 4 = Full thickness skin loss with extensive destruction, tissue necrosis, or damage to muscle, bone, or supporting structures or absent)."|4 weeks|||Percentage of participants|||Number
731087|NCT00401778|Secondary|Duration of Hospital Stay Following Surgery.||6 months|||days||Full Range|Median
731088|NCT00401778|Secondary|Safety and Tolerability of RAD001 as Pre-operative Therapy.||6 months||||||
731089|NCT00401778|Primary|Inhibition of Proliferation (Ki67) and Induction of Apoptosis (TUNEL Assay) in Tumor Specimens and Buccal Mucosa.||6 months||||||
731090|NCT00401778|Primary|Effects of RAD001 on the Regulation of Key Proteins Involved With the Mammalian Target of Rapamycin (mTOR) Axis in Tumor Specimens and Buccal Mucosa in Patients With Operable Non-small Cell Lung Cancer (NSCLC).|Changes in the expression of key signaling proteins in the mTOR/phosphatidylinositol 3-kinase (PI3K) pathway were determined by immunohistochemistry using previously published protocols and manufacturers’ recommendations for antigen retrieval and antibody dilution along with positive and negative controls. Two investigators assessed protein expression jointly by light microscopy. The degree of expression was assessed by intensity (0, 1+, 2+, 3+) and percentage of cell staining in line with published algorithm. A derivative score (immunoscore) ranging between 0 and 300 was calculated as the product of intensity and percent cell staining.|6 months|||% change in immunoscore||Standard Deviation|Mean
731091|NCT00401778|Primary|Clinical Response as Assessed Metabolically by Changes in Positron Emission Tomography (PET) Scan Between Baseline and Immediately Prior to Surgery.|All patients had baseline imaging in a fasted state with 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (18FDG)-PET scan and a repeat scan at 3 to 4 weeks later using routine clinical protocol for patient preparation, radiotracer administration and data acquisition. The repeat imaging occurred no longer than 24 hours before surgical resection.|Day 21|||percentage of patients|||Number
731092|NCT00401830|Secondary|Lacosamide Plasma Concentration at the End of the Maintenance Phase/ Week 12||End of the Maintenance Phase/Week 12|The number of patients in the Placebo treatment group has been presented as 0 as this outcome measure is not applicable for this treatment group. Of the 78 patients in the Lacosamide treatment group (Safety Set) data were available at the end of Maintenance Phase/Week 12 for the 45 patients remaining in the study.||ug/ML||Standard Deviation|Mean
731093|NCT00401830|Secondary|Change From Baseline in Fibromyalgia Symptom Scores to the Last Assessment in the 12-week Treatment Phase|All scores range from 0 to 10 with higher scores corresponding to a greater level of symptom severity.|Baseline, Last assessment in the 12-week Treatment Phase|Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 61 and 60 patients respectively are included in this summary based on the Full Analysis Set and have the Last Assessment in the 12-week Treatment Phase.||Score on a scale||Standard Deviation|Mean
731094|NCT00401830|Secondary|Percentage of Patients Using Alcohol for Pain During the 12-week Treatment Phase|Use of alcohol to treat pain in the past 24 hours was recorded (Yes/No response).|12-week Treatment Phase|Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in this summary based on the Full Analysis Set.||Percentage of patients|||Number
731095|NCT00401830|Secondary|Percentage of Patients Using Rescue Medication During the 12-week Treatment Phase|Subjects recorded use of rescue medication for pain in the diary daily in the evening with a Yes/No response.|12-week Treatment Phase|Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in this summary based on the Full Analysis Set.||Percentage of patients|||Number
731096|NCT00401830|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Scores to the Last Assessment in the 12-week Treatment Phase|The Hospital Anxiety and Depression Scale (HADS) is a self-administered instrument for detecting anxiety and depression in medical outpatients. Scores range from 0 to 21 for each subscale with higher scores reflecting a greater level of anxiety or depression.|Baseline, Last assessment in the 12-week Treatment Phase|Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in the Full Analysis Set (FAS). A total of 67 subjects in each treatment group in the FAS have change from Baseline data for depression. One subject in the Lacosamide group had a missing anxiety score.||Score on a scale||Standard Deviation|Mean
731097|NCT00401830|Secondary|Patient Global Impression of Change (PGIC) Assessment From Baseline to the Last Assessment in the 12-week Treatment Phase|The PGIC is a 7-point self-administered categorical rating scale in which the subject rated the change in pain since starting trial medication (from much worse [score of 1] to much better [score of 7]).|Baseline, Last assessment in the 12-week Treatment Phase|Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in the Full Analysis Set (FAS). A total of 67 subjects in each treatment group in the FAS have this assessment.||Patients|||Number
731098|NCT00401830|Secondary|Change From Baseline in Evening Pain Score to the Last 2 Weeks of the 12-week Treatment Phase|An 11-point Likert scale was used for subjects to assess pain, from 0 (no pain) to 10 (worst pain ever experienced).|Baseline, Last 2 weeks of the 12 week Treatment Phase|Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Full Analysis Set.||Score on a scale||Standard Deviation|Mean
731099|NCT00401830|Secondary|Change From Baseline in Morning Pain Score to the Last 2 Weeks of the 12-week Treatment Phase|An 11-point Likert scale was used for subjects to assess pain, from 0 (no pain) to 10 (worst pain ever experienced).|Baseline, Last 2 weeks of the 12 week Treatment Phase|Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Full Analysis Set.||Score on a scale||Standard Deviation|Mean
731129|NCT00401973|Primary|Change From Baseline to Endpoint in Weight||Baseline to endpoint (22 weeks)|All randomized participants with baseline and at least one postbaseline measurement.||kilograms||Standard Error|Least Squares Mean
731100|NCT00401830|Secondary|Change From Baseline in Daily Interference With General Activity to the Last 2 Weeks of the 12-week Treatment Phase|General activity scale - the subject rated how the pain had interfered with general activity, from 0 (did not interfere) to 10 (completely interfered)|Baseline, Last 2 weeks of the 12-week Treatment Phase|Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Full Analysis Set.||Score on a scale||Standard Deviation|Mean
731101|NCT00401830|Secondary|Change From Baseline in Average Daily Interference With Sleep to the Last 2 Weeks of the 12-week Treatment Phase|Sleep scale - the subject rated quality of sleep, from 0 (very good sleep) to 10 (very poor sleep)|Baseline, Last 2 weeks of the 12-week Treatment Phase|Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Full Analysis Set.||Score on a scale||Standard Deviation|Mean
731102|NCT00401830|Secondary|Change From Baseline in Total Myalgic Score to the Last Assessment in the 12-week Treatment Phase|Total Myalgic Score ranges from 0 to 54 with higher scores corresponding to a greater level of pain.|Baseline, Last assessment in the 12-week Treatment Phase|Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 79 and 78 patients respectively are included in this summary based on the Full Analysis Set and have the Last Assessment in the 12-week Treatment Phase.||Score on a scale||Standard Deviation|Mean
731103|NCT00401830|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score to the Last Assessment in the 12-week Treatment Phase|The Fibromyalgia Impact Questionnaire (FIQ) Total Score ranges from 0 to 100 with higher scores corresponding to a greater impact of fibromyalgia|Baseline, Last assessment in the 12-week Treatment Phase|Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 79 and 78 patients respectively are included in this summary based on the Full Analysis Set and have the Last Assessment in the 12-week Treatment Phase.||Score on a scale||Standard Deviation|Mean
731104|NCT00401830|Primary|Change From Baseline in Average Daily Pain Score to the Last 2 Weeks of the 12-week Treatment Phase (Based on the Per Protocol Set)|The average daily pain score is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst pain ever experienced).|Baseline, Last 2 weeks of the 12-week Treatment Phase|Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 36 and 41 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Per Protocol Set.||Score on a scale||Standard Deviation|Mean
731105|NCT00401830|Primary|Change From Baseline in Average Daily Pain Score to the Last 2 Weeks of the 12-week Treatment Phase (Based on the Full Analysis Set)|The average daily pain score is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst pain ever experienced).|Baseline, Last 2 weeks of the 12-week Treatment Phase|Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Full Analysis Set.||Score on a scale||Standard Deviation|Mean
731106|NCT00401843|Primary|Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|up to 5 years|The safety population included all participants who received at least 1 dose of study treatment in Part 1 or Part 2. Participants were analyzed as per actual treatment received.||participants|||Number
731107|NCT00401843|Secondary|Overall Survival|Overall survival was defined as the interval between the first administration of study agent or randomization (Part 2) and the participant’s death from any cause. For participants with unknown survival status as of the data cut-off date, overall survival was censored at the last date known to be alive.|up to 5 years|ITT population included all participants randomized in Part 2. Participants were analyzed as per initial randomization.||days||95% Confidence Interval|Median
731108|NCT00401843|Secondary|Percentage of Participants With Confirmed Complete Response (CR Rate)|CR rate was defined as the percentage of participants who achieved a confirmed CR before dexamethasone was added. CR: Absence of original M-protein in serum/urine by immunofixation,maintained for minimum of 6 weeks. The presence of oligoclonal bands consistent with oligoclonal immune reconstitution does not exclude CR; Less than 5 percent (%) plasma cells in bone marrow aspirate and also on trephine bone biopsy if biopsy is performed; No increase in size/number of lytic bone lesions; Disappearance of soft tissue plasmacytomas.|Randomization until disease progression (maximum up to 5 years)|Response-evaluable population:all participants in Part 2 with confirmed diagnosis of multiple myeloma and measurable,secretory disease:either serum M-protein 1 >= gram per deciliter(g/dL)/urine M-protein >200 mg per 24 hours,at study entry;had at least 1 study agent administration;at least 1 post-baseline disease assessment before dexamethasone.||percentage of participants|||Number
731109|NCT00401843|Secondary|Percentage of Participants With Best Confirmed Response of Complete Response (CR) or Partial Response (PR) (Overall Response Rate)|Overall response rate was defined as best response (CR/PR confirmed) for a participant recorded from first administration of study agent or randomization (Part 2) until disease progression/recurrence and before dexamethasone was added. CR: Absence of original M-protein in serum/urine by immunofixation,maintained for minimum of 6 weeks. The presence of oligoclonal bands consistent with oligoclonal immune reconstitution does not exclude CR; Less than 5 percent (%) plasma cells in bone marrow aspirate and also on trephine bone biopsy if biopsy is performed; No increase in size/number of lytic bone lesions; Disappearance of soft tissue plasmacytomas. PR: Greater than or equal to (>=) 50% reduction in level of serum M-protein, maintained for minimum of 6 weeks. Reduction in 24 hour urinary light chain excretion either by >= 90% or to < 200 mg, maintained for minimum of 6 weeks; >= 50% reduction in size of soft tissue plasmacytomas; No increase in size/number of lytic bone lesions.|Randomization until disease progression (maximum up to 5 years)|Response-evaluable population:all participants in Part 2 with confirmed diagnosis of multiple myeloma and measurable,secretory disease:either serum M-protein 1 >= gram per deciliter(g/dL)/urine M-protein >200 mg per 24 hours,at study entry;had at least 1 study agent administration;at least 1 post-baseline disease assessment before dexamethasone.||percentage of participants|||Number
731250|NCT00402714|Primary|Incidence of Grade 2-4 Acute Graft Versus Host Disease Following Allogeneic Stem Cell Transplantation in Patients Randomized to Photopheresis vs. no Photopheresis||Day +100 following allogeneic stem cell transplant|||participants|||Number
731110|NCT00401843|Primary|Progression-free Survival|Progression-free survival was defined as the time interval between randomization and the first documented sign of disease progression (including relapse from complete response [CR]) by the European Bone Marrow Transplant (EBMT) criteria or death, whichever occurred first. Relapse from CR requires at least 1 of the following: Reappearance of serum or urinary M-protein on immunofixation or routine electrophoresis, confirmed by at least 1 further investigation and excluding oligoclonal immune reconstitution; Greater than or equal to (>=) 5 percent (%) plasma cells either in a bone marrow aspirate or on trephine bone biopsy; Development of new lytic bone lesions or soft tissue plasmacytomas or definite increase in the size of residual bone lesions (development of a compression fracture does not exclude continued response and may not indicate progression); Development of hypercalcemia not attributable to any other cause.|Randomization until disease progression or death, which ever occured first (maximum up to 5 years)|Intent-to-treat (ITT) population included all participants randomized in Part 2. Participants were analyzed as per initial randomization.||days||95% Confidence Interval|Median
731111|NCT00401882|Secondary|Need for Additional Antiarrhythmic Drugs||120 minutes|Data point not analyzed|||||
731112|NCT00401882|Secondary|Total Duration of Resuscitative Efforts||120 minutes|Data point not analyzed|||||
731113|NCT00401882|Secondary|Number of Precordial Shocks Required After the Administration of Metoprolol or Epinephrine||120 minutes|Data point not analyzed|||||
731114|NCT00401882|Secondary|Adverse Effects||30 days|||Participants|||Count of Participants
731115|NCT00401882|Secondary|Survival to Hospital Discharge|the number of patients who are alive at hospital discharge|from time of arrest to discharge or death|||Participants|||Count of Participants
731116|NCT00401882|Primary|Return of Spontaneous Circulation|The patient will be evaluated for sufficiently stable and organized rhythm and blood pressure.|After electrical defibrillation|||Participants|||Count of Participants
731117|NCT00401960|Primary|Number of Participants With Muscle Toxicity or Renal Toxicity, as Determined by Predefined Criteria|Number of Participants with creatine kinase elevation > 3x upper limit of normal or elevations of serum Cr >= 30% above baseline|weekly|study terminated due to inadequate enrollment; therefore data not sufficient for planned analysis||Participants|||Count of Participants
731118|NCT00401960|Primary|Number of Participants With Any Grade 3 or 4 Toxicity (DAIDS Scale)|Number of Participants any Grade 3 or 4 toxicity (DAIDS scale); please see adverse event table for details|weekly|Study terminated due to insufficient enrollment; therefore data not sufficient for planned analysis||Participants|||Count of Participants
731119|NCT00401973|Secondary|Correlations Between Weight Changes and Changes in Eating Inventory (EI) and Food Craving Inventory (FCI) at 2 Weeks and 22 Weeks|To understand the drivers of weight gain as indicated by the correlation between weight changes and changes in the Eating Inventory (EI) and Food Craving Inventory (FCI). The EI is a 51-item inventory that measures dietary restraint, disinhibition, and perceived hunger. The FCI is a 28-item instrument measuring the frequency over the past month of general cravings and cravings for specific types of foods, namely: high fats, sweets, carbohydrates/starches, and fast-food fats. Correlations were computed on the combined treatment groups.|Baseline to endpoint (22 weeks)|N=Pairs of Observations for the combined treatment groups.||correlation|||Number
731120|NCT00401973|Secondary|Change From Baseline to Endpoint in Clinical Global Impression - Severity Scale (CGI-S)|Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Baseline to endpoint (22 weeks)|Number of participants with a baseline and at least one post baseline measurement. Last post-baseline measurement carried forward.||units on a scale||Standard Deviation|Mean
731121|NCT00401973|Secondary|Change From Baseline to Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline to endpoint (22 weeks)|Number of participants with a baseline and at least one post baseline measurement. Last post-baseline measurement carried forward.||units on a scale||Standard Deviation|Mean
731122|NCT00401973|Secondary|Change From Baseline to Endpoint in Brief Psychiatric Rating Scale (BPRS) Total Score|The BPRS is an 18-item clinician-administered scale used to assess the degree of severity of a subject's general psychopathological symptoms. Each item is rated on a scale from 1 (symptom not present) to 7 (symptom extremely severe). The BPRS total score ranges from 18 to 126.|Baseline to endpoint (22 weeks)|Number of participants with a baseline and at least one post baseline measurement. Last post-baseline measurement carried forward.||units on a scale||Standard Deviation|Mean
731123|NCT00401973|Secondary|Mean Change From Baseline to Endpoint in Hemoglobin A1c||Baseline to endpoint (22 weeks)|All randomized participants with baseline and at least one postbaseline measurement. Last post-baseline measurement carried forward.||percent hemoglobin A1c||Standard Deviation|Mean
731124|NCT00401973|Secondary|Mean Change From Baseline to Endpoint in Fasting Glucose||Baseline to endpoint (22 weeks)|All randomized participants with baseline and at least one postbaseline measurement. Last post-baseline measurement carried forward.||millimole per Liter (mmol/L)||Standard Deviation|Mean
731125|NCT00401973|Secondary|Mean Change From Baseline to Endpoint in Fasting Low Density Lipoprotein (LDL) Cholesterol||Baseline to endpoint (22 weeks)|All randomized participants with baseline and at least one postbaseline measurement. Last post-baseline measurement carried forward.||millimole per Liter (mmol/L)||Standard Deviation|Mean
731126|NCT00401973|Secondary|Mean Change From Baseline to Endpoint in Fasting High Density Lipoprotein (HDL) Cholesterol||Baseline to endpoint (22 weeks)|Number of randomized participants with a baseline and at least one post-baseline measurement. Last post-baseline measurement carried forward.||millimole per liter (mmol/L)||Standard Deviation|Mean
731127|NCT00401973|Secondary|Mean Change From Baseline to Endpoint in Fasting Total Cholesterol||Baseline to endpoint (22 weeks)|All randomized participants with baseline and at least one postbaseline measurement. Last post-baseline measurement carried forward.||millimole per Liter (mmol/L)||Standard Deviation|Mean
731128|NCT00401973|Secondary|Mean Change From Baseline to Endpoint in Fasting Triglycerides||Baseline to endpoint (22 weeks)|All randomized participants with baseline and at least one postbaseline measurement. Last post-baseline measurement carried forward.||millimoles per Liter (mmol/L)||Standard Deviation|Mean
731130|NCT00402025|Secondary|Change From Baseline in Pain Intensity|Pain was assessed by the participant using a validated Visual Analog Scale (VAS) pain assessment instrument. A single 10-cm line was used with the leftmost end (0 cm) representing “no pain” and the rightmost end (10 cm) representing “worst pain”. The distance was measured from the leftmost part of the scale to the mark made by the participant indicating pain level.|Baseline and Weeks 3 and 6|ITT population with available VAS data; this assessment was added in the third protocol amendment and change from baseline could only be assessed for participants in cohort 3.||cm||Standard Deviation|Mean
731131|NCT00402025|Primary|Number of Participants Positive for Anti-herpes Simplex Virus-1 (HSV-1) Antibodies|Anti-HSV-1 antibodies were detected using an enzyme-linked immunosorbent assay (ELISA).|Week 0 (Day 1, predose) and Week 3|ITT population with available antibody results (indicated by N)||participants|||Number
731132|NCT00402025|Primary|Number of Participants With Talimogene Laherparepvec Detected in Blood and Urine|Samples of blood and urine collected before and up to 24 hours after dosing were tested for the presence of talimogene laherparepvec deoxyribonucleic acid (DNA) using a validated quantitative polymerase chain reaction (qPCR) assay.|Treatment Day 1 predose and 2, 6, 12 and 24 hours postdose, and Week 3 and 6 at (predose and 2 hours postdose.|ITT population||participants|||Number
731133|NCT00402025|Secondary|Number of Participants With Overall Objective Response|"Tumor response was assessed via CT scan by the investigator using Response Evaluation Criteria In Solid Tumors (RECIST) v1.0 guidelines. Objective response is defined as a complete response (CR) or partial response (PR).
CR: Disappearance of all target and non-target lesions, normalization of tumor marker level and no new lesions and with confirmation no less than 4 weeks after the criteria for CR is first met.
PR: At least a 30% decrease in the sum of longest diameters of target lesions taking as reference the baseline sum of the longest diameters, absence of non-target lesion progression, and no new lesions. These criteria must be confirmed no less than 4 weeks after they are first met."|Every 6 weeks until 12 weeks after the last dose; the median duration of treatment was 44.0 days, 22.0 days, and 11.5 days in each group respectively.|ITT population||participants|||Number
731134|NCT00402025|Secondary|Change From Baseline in Sum of Longest Diameters of Injected Tumors|Spiral computed tomography (CT) scans were performed to assess tumors at screening and at Weeks 6, 12 and 18 after the initial dose.|Baseline and Week 6, 12 and 18|"ITT population with available data at each time point (indicated by N)."||mm||Standard Deviation|Mean
731135|NCT00402025|Primary|Number of Participants With Adverse Events|A serious adverse event is defined as any untoward medical occurrence that at any dose results in death, is life threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is an important and significant medical event that, based upon appropriate medical judgment, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed above.|From first dose of talimogene laherparepvec until 30 days after the last dose; the median duration of treatment was 44.0 days, 22.0 days, and 11.5 days in each group respectively.|ITT population||participants|||Number
731136|NCT00402051|Secondary|Pharmacology Toxicities|Number of patients experiencing Grade 3 or 4 hematologic and non-hematologic adverse events (AEs) possibly related to study drug or protocol procedures in this study (a subset of those listed in the AE Module). AEs were graded using the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) for defining and grading specific adverse events. A grading (severity) scale is provided for each adverse event term. Grades range from 0 (none) to 5 (death). Grade 3 AEs are severe and undesirable; Grade 4 AEs are life-threatening or disabling.|Every 21-day cycle for up to 6 cycles|Full Analysis Set: All patients randomized who received at least one dose of study drug||participants|||Number
731137|NCT00402051|Secondary|Time to Treatment Failure (TTF)|Defined as time from randomization to the first date of disease progression, death due to any cause, or early discontinuation of treatment (any reason), whichever occurred first|Randomization to stopping of treatment, progression, death or initiation of further chemotherapy, whichever occurs first (up to 1 year)|Full Analysis Set: All patients randomized who received at least one dose of study drug||months||95% Confidence Interval|Median
731138|NCT00402051|Secondary|Number of Participants With Tumor Response (as Basis for Response Rate)|"Best overall response was evaluated using RECIST Criteria which define when cancer patients improve (respond), stay the same (stabilize), or worsen (progression) during treatment. CR: complete response, disappearance of all target lesions; PR: partial response, 30% decrease in sum of the longest diameter of target lesions; PD: progressive disease, 20% increase in sum of the longest diameter of target lesions; SD: stable disease, small changes not meeting above criteria. Response Rate: number of participants with response(CR+PR)per total population, multiplied by 100 to give a percentage."|Every 6 weeks for 6 months during the treatment period, and every 3 months during the follow-up period, until disease progression|Full Analysis Set: All patients randomized who received at least one dose of study drug||participants|||Number
731139|NCT00402051|Secondary|Overall Survival|Defined as the time from randomization to the date of death from any cause.|Randomization to date of death from any cause (up to 1 year)|Full Analysis Set: All patients randomized who received at least one dose of study drug||months||95% Confidence Interval|Median
731140|NCT00402051|Primary|Percentage of Participants Surviving Progression-Free at 6 Months (Progression Free Survival [PFS] Rate)|For this study, we used the exponential distribution (assumption done for the calculation of the sample size) to estimate the PFS rate. The PFS rate (%) and the 95% confidence intervals were calculated based on the following formula: exp(-6 λ) ± 1.96 * exp(-6 λ) * (-6 λ)/√r. Where λ was calculated based on the Maximum-Likelihood estimator for ln(λ) as given by (Collett 2003): ln(λ) = ln[ r / ∑ti ] with r = number of patients with events up to 6 months, ti = survival time of patient i (i=1,…,n), event or censored up to 6 months, and n= total number of patients per treatment group.|Randomization to Month 6|Full Analysis Set: All patients randomized who received at least one dose of study drug||percentage|||Number
731141|NCT00402103|Secondary|Percentage of Patients Achieving a Response in Mean Sitting Diastolic Blood Pressure (msDBP)||Baseline, Week 2, Week 10, Week 28 and Week 54|Treated Population, Last observation carried forward (LOCF). Total combined treated patients are 556 out of which 470 patients are treated with Aliskiren and Amlodipine combination only and 86 patients are treated with Ali/Amlo/HCTZ combination.||Percentage of patients|||Number
731142|NCT00402103|Secondary|Percentage of Patients Achieving a Blood Pressure Control Target of <140/90 mmHg||Baseline, Week 2, Week 10, Week 28 and Week 54|Treated Population, Last observation carried forward (LOCF). Total combined treated patients are 556 out of which 470 patients are treated with Aliskiren and Amlodipine combination only and 86 patients are treated with Ali/Amlo/HCTZ combination.||Percentage of patients|||Number
731143|NCT00402103|Secondary|Change in Mean Sitting Diastolic Blood Pressure (msDBP)From Baseline to the Indicated Time Points||Baseline, Week 2, Week 4, Week 6, Week 10, Week 14, Week 28, Week 41 and Week 54|Treated population, Last observation carried forward (LOCF). Total combined treated patients are 556 out of which 470 patients are treated with Aliskiren and Amlodipine combination only and 86 patients are treated with Ali/Amlo/HCTZ combination.||mm Hg||Standard Deviation|Mean
731144|NCT00402103|Primary|Overall Percentage of Patients With Adverse Events||52 weeks|Treated Population||Percentage of Participants|||Number
731171|NCT00402194|Primary|Insulin-stimulated Leg Glucose Uptake||3 months|||mmol/min||Standard Deviation|Mean
731172|NCT00402194|Primary|Leg Blood Flow Response to Insulin||3 months|||Liters/minute||Standard Deviation|Mean
731173|NCT00402233|Secondary|Beck Depression Inventory II|Total score ranges from zero (best) to 63 (worst); scale has 21 items, each rated from zero (absent) to 3 (severe)|From baseline to week 12|Treated set||units on a scale||Standard Deviation|Mean
731174|NCT00402233|Secondary|Epworth Sleepiness Scale|Total score ranges from zero (best) to 24 (worst); scale has 8 items, each rated from zero (no chance of dozing) to 3 (high chance of dozing)|From baseline to week 12|Treated set||units on a scale||Standard Deviation|Mean
731175|NCT00402233|Secondary|Modified Hoehn and Yahr Stage|Score ranges from best 0 (no signs of disease) to worst 5 (wheelchair bound or bedridden unless aided)|From baseline to week 12|Treated set||units on a scale||Standard Deviation|Mean
731176|NCT00402233|Primary|Unified Parkinson's Disease Rating Scale (UPDRS) Total Score|Total score ranges from zero (best) to 176 (worst), as the sum of Parts I (Mental questions), II (Activity of Daily Living questions), and III (Motor examination)|From baseline to week 12|Treated set||units on a scale||Standard Deviation|Mean
731177|NCT00402246|Secondary|In-office Follow-up Burden: Hours Absent From Work Due to Visit|Subjects were asked at their one month visit to indicate on a survey how many hours of work they were missing to attend that visit.|1 month|All enrolled subjects who completed some portion of the caregiver burden survey and satisfied the inclusion/exclusion criteria were included.||Hours||Standard Deviation|Mean
731178|NCT00402246|Secondary|In-office Follow-up Burden: Patient Expenses|On a survey at the one month visit, the patient estimated their expenses in traveling to that visit.|1 month|All enrolled subjects who completed some portion of the caregiver burden survey and satisfied the inclusion/exclusion criteria were included.||Dollars||Standard Deviation|Mean
731179|NCT00402246|Secondary|In-office Follow-up Burden: Distance Traveled|Subjects' responses to the survey. Subjects were asked to provide the distance (in miles) from their home to the clinic/hospital.|1 month visit|All enrolled subjects who completed some portion of the caregiver burden survey and satisfied the inclusion/exclusion criteria were included.||Miles||Standard Deviation|Mean
731180|NCT00402246|Secondary|Clinic Personnel Satisfaction With Wireless Telemetry (Telemetry + Leadless ECG).|Following the completion of enrollment in the study, participating clinicians were asked to complete a survey assessing their overall satisfaction with the wireless telemetry feature. Clinicians' rating (1=strongly disagree, 5=strongly agree) of the overall satisfaction with the wireless telemetry feature of the device|After study enrollment has been completed; on average 15.8 months after the center had enrolled its first subject|All surveys in which clinician completed at least a subset of the questions were included.||Units on a scale||Standard Deviation|Mean
731181|NCT00402246|Secondary|Trait-Anxiety Scale|The Trait-Anxiety scales for each subject were obtained at multiple time points. The Trait-Anxiety scale was derived by summing the 20 scores in the Trait section of the STAI questionnaire. The Trait-Anxiety scales can vary from a minimum of 20 (best possible) to a maximum of 80 (worst possible).|1, 3, 6, 9, 12, and 15 months visits|All enrolled subjects who completed the STAI questionnaire for all scheduled follow-up visits/transmissions that occurred within specified visit windows and satisfied the inclusion/exclusion criteria were included in the analysis.||Scores on a scale||Standard Deviation|Mean
731182|NCT00402246|Secondary|State-Anxiety Scale|The State-Anxiety scales for each subject were obtained at multiple time points. The State-Anxiety scale was derived by summing the 20 scores in the State section of the State-Trait Anxiety Inventory (STAI) questionnaire. The State-Anxiety scales can vary from a minimum of 20 (best possible) to a maximum of 80 (worst possible).|1, 3, 6, 9, 12, and 15 month visit|All enrolled subjects who completed the STAI questionnaire for all scheduled follow-up visits/transmissions that occurred within specified visit windows and satisfied the inclusion/exclusion criteria were included in the analysis.||Scores on a scale||Standard Deviation|Mean
733705|NCT00422097|Secondary|Area Under the Concentration-time Curve in 1 Dosing Interval (AUC[TAU])of Ixabepilone||Days 1 and 5 of Cycle 1|All participants who received ixabepilone and who had adequate concentration profiles.||ng*h/mL||Standard Deviation|Mean
731183|NCT00402246|Secondary|Variability in Left Ventricular (LV) Threshold as Measured by Left Ventricular Capture Management (LVCM)|"LV Capture Threshold is the required energy(volts) necessary to cause the left ventricule to contract. It is important that a device which paces the left ventricule be set to a threshold such that current conducted through the left ventricular lead will induce contraction in the left ventricle. However, these thresholds may vary over time.
The standard deviation and range (maximum LVCM threshold - minimum LVCM threshold) of the most recent 14 days of LVCM results prior to each follow-up visit were determined for each subject and used to assess within-patient variability in LV thresholds."|1, 3, 6, 9, 12, and 15 months visits|All enrolled subjects who were implanted with a Concerto CRT-D (Cardiac Resynchronization Therapy with Defibrillation)device, met inclusion/exclusion criteria, and had daily LVCM measurement for at least one of the 6 scheduled visits/transmissions were included in the analysis.||Volts||Standard Deviation|Mean
731184|NCT00402246|Secondary|CareLink Transmission Compliance|The CareLink Transmission Compliance Rate for a particular visit (e.g. 3 month visit) is the proportion (ranging from 0 to 1) of subjects with device interrogation data remotely transmitted via the CareLink system on the date it was scheduled to be sent for that visit. The proportion is a fraction in which the denominator is the number of subjects in the Remote Arm who were not exited from the trial prior to the visit of interest, and the numberator is the number of Remote Arm subjects who successfully transmitted device data via the CareLink system on the date it was scheduled to be sent.|3, 6, 9, 12 months visits|9 of 1014 remote arm subjects did not meet the inclusion/exclusion criteria and were excluded from the analysis. The remaining 1005 remote arm subjects were included in the analysis.||Proportion of subjects||95% Confidence Interval|Mean
731185|NCT00402246|Other Pre-specified|Length of Hospital Stay (LOS)|LOS per cardiovascular hospitalization|Enrollment to last visit (up to 15 month post-implant)|All enrolled subjects who satisfied the inclusion/exclusion criteria and had at least one cardiovascular hospitalization were included in the analysis.||Days||Standard Error|Mean
731186|NCT00402246|Secondary|Time Per Patient From a Clinical Event Onset to a Clinical Decision for Both Device Events and Symptom-driven Device Interrogations|Days from device detection of a clinical event or a symptom-driven device interrogation event onset to a clinical decision, as reported by the clinician or as evidenced by device data obtained at interrogation. A clinical event is an event as defined in the primary objective. A symptom-driven device interrogation event is defined as a subject complaint received by the managing clinician in which the clinician determines that he/she must interrogate the subject's device to properly treat the subject.|From event onset to clinical decision|All enrolled subjects who experienced at least one event and satisfied the inclusion/exclusion criteria were included in the analysis.||Days||Standard Deviation|Mean
731187|NCT00402246|Secondary|Time Per Patient From a Clinical Event Onset to a Clinical Decision for Symptom-driven Device Interrogations|Days from a symptom-driven device interrogation event onset to a clinical decision being made in response to the event as reported by the clinician. An event is defined as a subject complaint received by the managing clinician in which the clinician determines that he/she must interrogate the subject's device to properly treat the subject.|Enrollment to last visit (up to 15 month post-implant)|All enrolled subjects who experienced at least one event and satisfied the inclusion/exclusion criteria were included in the analysis.||Days||Standard Deviation|Mean
731188|NCT00402246|Secondary|AT/AF Alert Treatment|Count of the treatment (i.e. hospitalization, ED visit, unscheduled clinic office/urgent care visits) in response to the AT/AF alerts|Enrollment to last visit (up to 15 month post-implant)|All enrolled remote patients who had at least one AT/AF alert were included in the analysis.||Alerts|Participants||Number
731189|NCT00402246|Secondary|Symptomatic AT/AF Alerts|AT/AF represents atrial tachycardia or atrial fibrillation which are arrhythmias involving rapid beating of the atrial chambers of the heart. The devices in this study store how many hours each day that a patient experiences AT/AF. The patient may not be aware they are experiencing these atrial arrhythmias, but if the AT/AF is accompanied by symptoms, the AT/AF is said to be symptomatic AT/AF. Devices in this study have an alert that fires if the patient experiences at least a programmed amount of AT/AF in a day. Measure is count of symptomatic AT/AF alerts as classified by the clinician|Enrollment to last visit (up to 15 month post-implant)|All enrolled remote patients who experienced at least one AT/AF alert were included in the analysis. AT/AF alerts there were not classified by the clinician as symptomatic or asymptomatic were excluded from the analysis.||Alerts|Participants||Number
731190|NCT00402246|Secondary|Clinically Meaningful Alerts|Count of clinically meaningful alerts as classified by the clinician|Enrollment to last visit (up to 15 month post-implant)|All enrolled remote subjects who experienced at least one alert were included in the analysis. Alerts that were not classified by the clinician as clinically meaningful or not were excluded from the analysis.||Alerts|Participants||Number
731191|NCT00402246|Secondary|Actions Taken for HCU Visits|Count of HCU visits that involved specific actions taken|Enrollment to last visit (up to 15 month post-implant)|||Visits|||Number
731192|NCT00402246|Secondary|Health Care Utilization: TEEs|Count of Transesophageal echocardiograms (TEEs) performed|Enrollment to last visit (up to 15 months post-implant)|9 remote arm patients and 8 in-office arm patients did not meet the inclusion/exclusion criteria. The remaining 1005 remote arm patients and 975 in-office arm patients were included in the analysis. An intention to treat analysis was performed for this objective.||Procedures|||Number
731193|NCT00402246|Secondary|Health Care Utilization (HCU)|Count of HCU visits for each HCU type (cardiovascular (CV) hospitalizations, cardiovascular (CV) emergency department (ED), and cardiovascular (CV) unscheduled clinic office/urgent care visits)|Enrollment to last visit (up to 15 month post-implant)|9 remote arm patients and 8 in-office arm patients did not meet the inclusion/exclusion criteria. The remaining 1005 remote arm patients and 975 in-office arm patients were included in the analysis. An intention to treat analysis was performed for this objective.||Visits|||Number
731209|NCT00402337|Secondary|Change From Baseline in Straining Score for the Treatment Period|Straining was assessed using a 5-point ordinal scale, whereby a score of 1 = not at all, 2 = a little bit, 3 = a moderate amount, 4 = a great deal, and 5 = an extreme amount.|Change from Baseline to Week 4|"307 patients who received ≥ 1 capsule of study drug and had ≥ 1 post-baseline response to the IVRS Treatment Period Question #12 How many bowel movements did you have today or yesterday since your last call? were included in the ITT Population. 29 patients with no pretreatment spontaneous bowel movements were excluded from the Straining analysis."||units on a scale||Standard Error|Least Squares Mean
731194|NCT00402246|Primary|Time Per Patient From a Clinical Event to a Clinical Decision in Response to Arrhythmias, Cardiovascular (CV) Disease Progression, and Device Issues|Days from device detection of a clinical event to a decision being made in response to the event, as reported by the clinician or as evidenced by device data obtained at interrogation. A clinical event could be any of the following that satisfied pre-specified thresholds: arrhythmias (e.g. at least 12 hours of atrial tachycard/atrial fibrillation in a day), cardiovascular disease progression (e.g. multiple device shocks delivered to terminate a single episode), or device issues (e.g. low battery).|Enrollment to last visit (up to 15 month post-implant)|All enrolled subjects who experienced at least one event and satisfied the inclusion/exclusion criteria were included in the analysis. An intention to treat analysis was performed for this objective.||days||Inter-Quartile Range|Median
731195|NCT00402285|Primary|Changes in Normal Prostate Tissue Gene Expression Between the Baseline and 3-month Biopsies in IGF -1 and COX -2|Comparisons of the change in deltaCT were between the placebo and Lycopene arms for IGF-1 and IGF-1R and between the placebo and fish oil arms for COX-2. Data in the table are mean changes in qRTPCR gene expression (normalized to GUSb) for IGF1, Cox2, and IGF1R.|baseline through 3 month|1 ppt randomized to fish oil had un-evaluable COX-2 at 3 months.||fold change||Standard Deviation|Mean
731196|NCT00402324|Secondary|Clinically Significant Vital Signs - Percentage of Participants With Baseline-to-Endpoint Weight Increase of at Least Seven Percent (7%)|Percentages of participants in each group who experienced an increase in weight of at least 7% from baseline to endpoint.|Baseline to endpoint (6 weeks)|All randomized participants with both baseline and post-baseline measures. Intention to Treat analysis.||percentage of participants|||Number
731197|NCT00402324|Secondary|Clinically Significant Vital Signs - Weight Change From Baseline|Change from baseline to endpoint: Value of weight measure at endpoint minus value at baseline.|Baseline to endpoint (6 weeks)|All randomized participants with both baseline and post-baseline measures. Intention to Treat analysis.||kilograms||Standard Error|Least Squares Mean
731198|NCT00402324|Secondary|Clinically Significant Vital Signs - Body Mass Index Change From Baseline|Change from baseline to endpoint in body mass index (an estimate of body fat derived by dividing body weight by height squared): Value of body mass index measure at endpoint minus value at baseline.|Baseline to endpoint (6 weeks)|All randomized participants with both baseline and post-baseline measures. Intention to Treat analysis.||kilograms per square meters||Standard Error|Least Squares Mean
731199|NCT00402324|Secondary|Clinically Significant Laboratory Values - Bilirubin Total Change From Baseline|Change from baseline to endpoint in bilirubin total: Value of bilirubin total measure at endpoint minus value at baseline.|Baseline to endpoint (6 weeks)|All randomized participants with both baseline and post-baseline measures. Intention to Treat analysis.||micromoles per Liter||Standard Deviation|Mean
731200|NCT00402324|Secondary|Clinically Significant Laboratory Values - Fasting Blood Glucose Change From Baseline|Change from baseline to endpoint in fasting blood glucose: Value of fasting blood glucose measure at endpoint minus value at baseline.|Baseline to endpoint (6 weeks)|All randomized participants with both baseline and post-baseline measures. Intention to Treat analysis.||milligrams per deciliter||Standard Deviation|Mean
731201|NCT00402324|Secondary|Clinically Significant Laboratory Values - Fasting Triglycerides Change From Baseline|Change from baseline to endpoint in triglycerides: Value of triglyceride measure at endpoint minus value at baseline.|Baseline to endpoint (6 weeks)|All randomized participants with both baseline and post-baseline measures. Intention to Treat analysis.||milligrams per deciliter||Standard Deviation|Mean
731202|NCT00402324|Secondary|Clinically Significant Laboratory Values - Fasting Cholesterol Change From Baseline|Change from Baseline to endpoint in cholesterol: value of cholesterol measure at endpoint minus the value at baseline.|Baseline to endpoint (6 weeks)|All randomized participants with both baseline and at least one post-baseline measure. Intention to Treat analysis.||milligrams per deciliter||Standard Deviation|Mean
731203|NCT00402324|Secondary|Number of Patients Hospitalized Due to Relapse of Mania or Depression.|Number of participants hospitalized as a result of relapse of mania or depression.|Baseline to endpoint (6 weeks)|Intent to Treat analysis. All randomized patients.||participants|||Number
731204|NCT00402324|Secondary|Mean Change in Clinical Global Impression for Bipolar Illness Severity (CGI-BP) From Baseline to Endpoint|CGI-BP Severity is used by the clinician to record the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Baseline to endpoint (6 weeks)|Intent to Treat analysis. Number of randomized patients with baseline and at least one nonmissing postbaseline value. Last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
731205|NCT00402324|Secondary|Number of Participants Meeting the Criteria for Mixed Response|The original outcome measure was Time to Mixed Response(at least a 50% reduction on HAMD and YMRS total scores from baseline); however since upper limit of measure of dispersion could not be computed by observed data, which is not allowed on this system, number of patients with event are presented instead.|baseline to endpoint (6 weeks)|All randomized participants with both baseline and post-baseline measures. Intention to Treat analysis.||participants|||Number
731206|NCT00402324|Secondary|Number of Participants Meeting the Criteria for Mixed Onset of Action|The original outcome measure was Time to Mixed Onset of Action (at least a 25% reduction on HAMD and YMRS total scores from baseline); however since upper limit of measure of dispersion could not be computed by observed data, which is not allowed on this system, number of patients with event are presented instead.|Baseline to endpoint (6 weeks)|All randomized participants with both baseline and post-baseline measures. Intention to Treat analysis.||participants|||Number
731207|NCT00402324|Primary|Mean Change in Hamilton Depression Rating Scale-21 (HAMD) Scores From Baseline to Endpoint.|The 21-item HAMD measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 60.|Baseline to endpoint (6 weeks)|Intent to Treat analysis. All randomized patients with baseline & at least one post-baseline measure.||units on a scale||Standard Error|Least Squares Mean
731208|NCT00402324|Primary|Mean Change in Young Mania Rating Scale (YMRS) Scores From Baseline to Endpoint.|The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.|Baseline to endpoint (6 weeks)|Intent to Treat analysis. All randomized patients with baseline & at least one post-baseline measure.||units on a scale||Standard Error|Least Squares Mean
731210|NCT00402337|Secondary|Change From Baseline in Stool Consistency (BSFS) Score for the Treatment Period|Stool consistency analyses were performed using the 7-point BSFS, whereby a score of 1 = difficult to pass; 2 = sausage shaped but lumpy; 3 = like a sausage but with cracks on surface; 4 = like a sausage or snake, smooth and soft; 5 = soft blobs with clear-cut edges (passed easily); 6 = fluffy pieces with ragged edges, a mushy stool; and 7 = entirely liquid.|Change from Baseline to Week 4|"307 patients who received ≥ 1 capsule of study drug and had ≥ 1 post-baseline response to the IVRS Treatment Period Question #12 How many bowel movements did you have today or yesterday since your last call? were included in the ITT. 29 patients with no pretreatment spontaneous bowel movements were excluded from the Stool Consistency analysis."||units on a scale||Standard Error|Least Squares Mean
731211|NCT00402337|Secondary|Change From Baseline in the Weekly Normalized CSBM Rate for the Treatment Period|CSBMs measured daily during the treatment period. During each daily phone call into the IVRS, patients were asked: How many bowel movements did you have today or yesterday after your last call?|Change from Baseline to Week 4|"307 patients who received ≥ 1 capsule of study drug and had ≥ 1 post-baseline response to the IVRS Treatment Period Question #12 How many bowel movements did you have today or yesterday since your last call? were included in the ITT Population."||CSBMs per week||Standard Error|Least Squares Mean
731212|NCT00402337|Secondary|CSBM 75% Responder for the Treatment Period (Based on the Normalized Rate)|"A patient was a complete spontaneous bowel movement (CSBM) 75% Responder if the patient was a CSBM Responder for ≥3 of the 4 treatment period weeks.
For each week of the treatment and postreatment periods, a patient was considered a CSBM Responder if for that week the patient 1) completed ≥4 days of IVRS questions,2) had a CSBM rate of ≥ 3 for the week, and 3) had an increase in CSBM rate of ≥ 1 from their baseline weekly CSBM rate."|Change from Baseline to Week 4|"307 patients who received ≥ 1 capsule of study drug and had ≥ 1 post-baseline response to the IVRS Treatment Period Question #12 How many bowel movements did you have today or yesterday since your last call? were included in the ITT Population."||participants|||Number
731213|NCT00402337|Secondary|SBM 75% Responder for the Treatment Period (Based on the Normalized Rate)|"A patient was an SBM 75% Responder if the patient was an SBM Responder for ≥3 of the 4 treatment period weeks.
For each week of the treatment and postreatment periods, a patient was considered an SBM Responder if for that week the patient 1) completed ≥4 days of IVRS questions,2) had an SBM rate of ≥ 3 for the week, and 3) had an increase in SBM rate of ≥ 1 from their baseline weekly SBM rate."|Change from Baseline to Week 4|"307 patients who received ≥ 1 capsule of study drug and had ≥ 1 post-baseline response to the IVRS Treatment Period Question #12 How many bowel movements did you have today or yesterday since your last call? were included in the ITT Population."||participants|||Number
731214|NCT00402337|Primary|Change From Pretreatment in Weekly Normalized Spontaneous Bowel Movement (SBM) Frequency|Change in SBM frequency during Weeks 1 through 4 of the treatment period from the weekly SBM rate obtained during the pretreatment period.|Change from Baseline to Week 4|307 patients who received ≥ 1 capsule of study drug and had ≥ 1 post-baseline response to the IVRS Treatment Period Question #12 “How many bowel movements did you have today or yesterday since your last call?” were included in the intent-to-treat (ITT) Population.||SBMs per week||Standard Error|Least Squares Mean
731215|NCT00402363|Secondary|Annualized Cumulative Frequency of Symptomatic AF Recurrences During the Treatment Period|Values were annualized by counting the number of episodes of symptomatic AF recurrences (maximum of one per day), dividing by the number of days on treatment, then multiplying this number by 365.25.|From first dose of study drug (Day 1) to the last dose of study drug (up to Week 24)|MITT Population. The number analyzed represents those participants with an event.||recurrences||Inter-Quartile Range|Median
731216|NCT00402363|Secondary|Annualized Cumulative Frequency of Symptomatic AF/Flutter Recurrences During the Treatment Period|Values were annualized by counting the number of episodes of symptomatic AF/flutter recurrences (maximum of one per day), dividing by the number of days on treatment, then multiplying this number by 365.25.|From first dose of study drug (Day 1) to the last dose of study drug (up to Week 24)|MITT Population. The number analyzed represents those participants with an event.||recurrences||Inter-Quartile Range|Median
731217|NCT00402363|Secondary|Annualized Number of AF/Flutter Rescue Episodes During the Treatment Period|Rescue was defined as any pharmacological/electrical/surgical intervention for the termination/prevention of AF/flutter with a maximum of one rescue episode counted per day. Note: all annualized values were calculated by counting the number of rescue episodes, dividing by the number of days on treatment, then multiplying that number by 365.25.|From first dose of study drug (Day 1) to the last dose of study drug (up to Week 24)|MITT Population. The number analyzed represents those participants who had a rescue episode.||rescue episodes||Inter-Quartile Range|Median
731218|NCT00402363|Secondary|Number of Participants in the Combined AF Subgroups With an Event That Occurred After Completion of Day 7 to the Occurrence of Symptomatic AF (Exclusive of Flutter)|"A documented episode of symptomatic AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Censored in the table below refers to participants who did not have a documented episode of symptomatic AF."|From completion of Day 7 of study drug to the first symptomatic recurrence of AF (up to Week 24)|MITT Population. Participants with events that occurred in the first 7 days were excluded from analysis.||participants|||Number
731219|NCT00402363|Secondary|Number of Participants With Paroxysmal or Persistent AF With an Event That Occurred After Completion of Day 7 to the Occurrence of Symptomatic AF (Exclusive of Flutter)|"A documented episode of symptomatic AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Censored in the table below refers to participants who did not have a documented episode of symptomatic AF."|From completion of Day 7 of study drug to the first symptomatic recurrence of AF (up to Week 24)|MITT Population. Participants with events that occurred in the first 7 days were excluded from analysis.||participants|||Number
731244|NCT00402688|Secondary|Clinical Success (Non-Relapse) or Failure (Relapse)|Number of Clinical Successes or Failures at the 6-month Poststudy Telephone Contact For Participants Cured/Improved at the Posttherapy Visit|Poststudy Telephone Contact at 6 Months|Modified Intent to Treat (mITT) (Participants Cured/Improved at the Posttherapy Visit)||Participants|||Number
731245|NCT00402688|Secondary|Clinical Success (Non-Relapse) or Failure (Relapse)|Number of Clinical Successes or Failures at 3 Month Poststudy Telephone Contact for Participants Cured/Improved at the Posttherapy Visit|Poststudy Telephone contact at 3 Months|Modified Intent to Treat (mITT) (Participants Cured/Improved at the Posttherapy Visit)||Participants|||Number
731220|NCT00402363|Secondary|Number of Participants in the Combined AF Subgroups With an Event After Completion of Day 7 to the Occurrence of Symptomatic AF/Flutter|"A documented episode of symptomatic AF/flutter was defined as AF/flutter documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Atrial flutter, a closely related rhythm disorder, was distinguished from AF by the presence of distinctive flutter p-waves at regluar intervals. Censored in the table below refers to participants who did not have a documented episode of symptomatic AF/flutter."|From completion of Day 7 of study drug to the first symptomatic recurrence of AF/flutter (up to Week 24)|MITT Population. Participants with events that occurred in the first 7 days were excluded from analysis.||participants|||Number
731221|NCT00402363|Secondary|Number of Participants With Paroxysmal or Persistent AF With an Event After Completion of Day 7 to the Occurrence of Symptomatic AF/Flutter|"A documented episode of symptomatic AF/flutter was defined as AF/flutter documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Atrial flutter, a closely related rhythm disorder, was distinguished from AF by the presence of distinctive flutter p-waves at regluar intervals. Censored in the table below refers to participants who did not have a documented episode of symptomatic AF/flutter."|From completion of Day 7 of study drug to the first symptomatic recurrence of AF/flutter (up to Week 24)|MITT Population. Participants with events that occurred in the first 7 days were excluded from analysis.||participants|||Number
731222|NCT00402363|Secondary|Number of Participants in Both AF Subgroups Combined With an Event of Documented Symptomatic or Asymptomatic AF (Exclusive of Flutter)|"A documented episode of symptomatic or asymptomatic AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Asymptomatic episodes of AF were recorded by TTM during routine bi-weekly transmissions. Censored in the table below refers to participants who did not have a documented episode of symptomatic or asymptomatic AF/flutter."|From first dose of study drug (Day 1) to the first symptomatic or asymptomatic recurrence of AF (up to Week 24)|MITT Population||participants|||Number
731223|NCT00402363|Secondary|Number of Participants With Paroxysmal or Persistent AF With an Event of Documented Symptomatic or Asymptomatic AF (Exclusive of Flutter)|"A documented episode of symptomatic or asymptomatic AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Asymptomatic episodes of AF were recorded by TTM during routine bi-weekly transmissions. Censored in the table below refers to participants who did not have a documented episode of symptomatic or asymptomatic AF/flutter."|From first dose of study drug (Day 1) to the first symptomatic or asymptomatic recurrence of AF (up to Week 24)|MITT Population||participants|||Number
731224|NCT00402363|Secondary|Number of Participants in Both AF Subgroups Combined With an Event of Documented Symptomatic or Asymptomatic AF/Flutter|"A documented episode of symptomatic or asymptomatic AF/flutter was defined as AF/flutter documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Asymptomatic episodes of AF or flutter were recorded by TTM during routine bi-weekly transmissions. Atrial flutter, a closely related rhythm disorder, was distinguished from AF by the presence of distinctive flutter p-waves at regluar intervals. Censored in the table below refers to participants who did not have a documented episode of symptomatic or asymptomatic AF/flutter."|From first dose of study drug (Day 1) to the first symptomatic or asymptomatic recurrence of AF/flutter (up to Week 24)|MITT Population||participants|||Number
731225|NCT00402363|Secondary|Number Participants With Paroxysmal or Persistent AF With an Event of Documented Symptomatic or Asymptomatic AF/Flutter|"A documented episode of symptomatic or asymptomatic AF/flutter was defined as AF/flutter documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Asymptomatic episodes of AF or flutter were recorded by TTM during routine bi-weekly transmissions. Atrial flutter, a closely related rhythm disorder, was distinguished from AF by the presence of distinctive flutter p-waves at regluar intervals. Censored in the table below refers to participants who did not have a documented episode of symptomatic or asymptomatic AF/flutter."|From first dose of study drug (Day 1) to the first symptomatic or asymptomatic recurrence of AF/flutter (up to Week 24)|MITT Population||participants|||Number
731226|NCT00402363|Secondary|Number of Participants in Both AF Subgroups Combined With an Event of Documented Symptomatic AF (Exclusive of Atrial Flutter)|"A documented episode of symptomatic AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Censored in the table below refers to participants who did not have a documented episode of symptomatic AF."|From first dose of study drug (Day 1) to the first symptomatic recurrence of AF (up to Week 24)|MITT Population||participants|||Number
731227|NCT00402363|Secondary|Number of Participants With Paroxysmal AF or Persistent AF With an Event of Documented Symptomatic AF (Exclusive of Atrial Flutter)|"A documented episode of symptomatic AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Censored in the table below refers to participants who did not have a documented episode of symptomatic AF."|From first dose of study drug (Day 1) to the first symptomatic recurrence of AF (up to Week 24)|MITT Population||participants|||Number
731228|NCT00402363|Secondary|Number of Participants With Persistent AF and in Both AF Subgroups Combined With an Event of Documented Symptomatic AF/Flutter|"A documented episode of symptomatic AF/flutter was defined as AF/flutter documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Atrial flutter, a closely related rhythm disorder, was distinguished from AF by the presence of distinctive flutter p-waves at regluar intervals. The occurrence of symptomatic atrial flutter was treated as an occurrence of symptomatic AF for this outcome measure. Censored in the table below refers to participants who did not have a documented episode of symptomatic AF or flutter."|From first dose of study drug (Day 1) to the first symptomatic recurrence of AF/flutter (up to Week 24)|MITT Population||participants|||Number
731246|NCT00402688|Secondary|Clinical Success (Non-Relapse) or Failure (Relapse)|Number of Clinical Successes or Failures at the 6-Week Poststudy Telephone Contact for Participants Cured/Improved at the Posttherapy Visit|Poststudy Telephone contact at 6 weeks|Modified Intent-to-Treat Population (mITT) (Participants Cured/Improved at the Posttherapy Visit)||participants|||Number
733706|NCT00422097|Secondary|Time of Maximum Plasma Concentration (Tmax) of Ixabepilone||Days 1 and 5 of Cycle 1|All participants who received ixabepilone and who had adequate concentration profiles||Hour||Full Range|Median
731229|NCT00402363|Primary|Number of Participants With Paroxysmal AF With an Event of Documented Symptomatic Atrial Fibrillation (AF)/Flutter|"A documented episode of symptomatic AF /Flutter was defined as AF/Flutter documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Atrial flutter, a closely related rhythm disorder, was distinguished from AF by the presence of distinctive flutter p-waves at regluar intervals. The occurrence of symptomatic atrial flutter was treated as an occurrence of symptomatic AF for this outcome measure. Censored in the table below refers to participants who did not have a documented episode of symptomatic AF or flutter."|From first dose of study drug (Day 1) to the first symptomatic recurrence of AF/flutter (up to Week 24)|Modified Intent-to-Treat (MITT) Population: all randomized participants who provided at least one post-randomization TTM ECG data transfer or equivalent||participants|||Number
731230|NCT00402597|Secondary|The Composite Endpoint of Death (All Cause), MI (or reMI), Stroke, Severe Recurrent Ischemia Requiring Revascularization, or Thrombolysis in Myocardial Infarction (TIMI) (Major or Minor Bleeding) to Assess the Net Clinical Benefit|The number of patients who died due to any cause or had a first occurrence of MI (or repeat MI), or stroke, or severe recurrent ischemia requiring revascularization, or TIMI (major or minor bleeding) from the time of randomization to the last date of patient contact to assess the net clinical benefit of rivaroxaban.|Day 1 to Day 210|The ITT population consisted of all patients who were randomized to treatment, regardless of study drug intake.||Patients|||Number
731231|NCT00402597|Secondary|The Number of Deaths (All Cause)|The number of patients who died due to any cause from the time of randomization to the last date of patient contact.|Day 1 to Day 210|The ITT population consisted of all patients who were randomized to treatment, regardless of study drug intake.||Patients|||Number
731232|NCT00402597|Secondary|The Composite Endpoint of Cardiovascular Death, Myocardial Infarction (MI), or Stroke|The number of patients with the composite endpoint of cardiovascular death or MI or stroke that occurred from the time of randomization to the last date of patient contact.|Day 1 to Day 210|The ITT population consisted of all patients who were randomized to treatment regardless of study drug intake.||Patients|||Number
731233|NCT00402597|Secondary|The Composite Endpoint of Death (All Cause), Myocardial Infarction (MI) (or Repeat MI), or Stroke|The number of patients who died due to any cause or had a first occurrence of MI (or repeat MI) or stroke from the time of randomization to the last date of patient contact.|Day 1 to Day 210|The ITT population consisted of all patients who were randomized to treatment, regardliess of study drug intake.||Patients|||Number
731234|NCT00402597|Primary|The Composite Endpoint of All Cause Death, Myocardial Infarction (MI) (Including Repeat MI), Stroke (Ischemic, Hemorrhagic or Unknown), or Severe Recurrent Ischemia Requiring Revascularization (Primary Efficacy)|The number of patients who died due to any cause or had a first occurrence of MI (including repeat MI) or stroke (ischemic, hemorrhagic or unknown) or severe recurrent ischemia requiring revascularization from the time of randomization to the last date of patient contact.|Day 1 to Day 210|The intent-to-treat (ITT) population consisted of all patients who were randomized to treatment, regardless of study drug intake.||Patients|||Number
731235|NCT00402597|Primary|Thrombolysis in Myocardial Infarction (TIMI) Clinically Significant Bleeding Events (Primary Safety)|The number of patients with a first occurrence of a TIMI clinically significant bleeding event that occurred from the time of randomization to the time of the last patient contact. TIMI clinically significant bleeding events included TIMI minor bleeding events, TIMI major bleeding events, or any bleeding that required medical attention.|Day 1 to Day 210|The safety population consisted of all randomized patients who took at least 1 dose of study medication after randomization during the double-blind treatment period.||Patients|||Number
731236|NCT00402649|Primary|Occurrence of Serious Adverse Events|Number of subjects with Serious Adverse Events during the 6 months after the first vaccination.|6 months after the first vaccination|||Participants|||Number
731237|NCT00402649|Primary|Occurrence of Unsolicited Adverse Events|Number of subjects with spontaneous reports of Adverse Events of any and severe severities. Events reported by more than 5.6% of subjects in any group are reported by MedDRA Preferred Term.|Through Day 28 after second vaccination|||Participants|||Number
731238|NCT00402649|Primary|Occurrence of the Solicited Adverse Event of Body Aches, Solicited Only From Children Age 6-10|Number of subjects reporting solicited Adverse Event of Body Aches, collected on Memory Aid for Days 0-7 post each vaccination for children age 6-10 only (systematic assessment), of any and severe severities.|Days 0-7 post each vaccination|Solicited symptom of Body Aches was collected from subjects age 6-10 only||Participants|||Number
731239|NCT00402649|Secondary|Number of Participants With a Four-fold or Greater Increase in Hemagglutination Inhibition Antibody Titers|Number of subjects with a 4-fold or greater increase, relative to baseline, in hemagglutination inhibition antibody titers after receipt of two doses of vaccine.|Day 28 after second vaccination|Blood draw was optional - blood collected from 16 participants post vaccination, but missing baseline assessment for 3 of 16 subjects||Participants|||Number
731240|NCT00402649|Secondary|Geometric Mean Titer of Hemagglutination Inhibition Antibody Titers|Geometric mean titer of hemagglutination inhibition antibody titers after receipt of two doses of vaccine.|Day 28 after second vaccination|Blood draw was optional - blood collected from 16 participants||Titer||95% Confidence Interval|Geometric Mean
731241|NCT00402649|Secondary|Number of Participants With Serum Hemagglutination Inhibition (HAI) Antibody Titers of 1:40 or Greater|Number of subjects achieving serum hemagglutination inhibition antibody titer of 1:40 or greater against the influenza A/H5N1 virus after receipt of two doses of vaccine.|Day 28 after second vaccination|Blood draw was optional - blood collected from 16 participants||Participants|||Number
731242|NCT00402649|Primary|Occurrence of Solicited Adverse Events Among All Subjects|Number of subjects reporting solicited Adverse Events collected on Memory Aid for Days 0-7 post each vaccination for all subjects (systematic assessment), for any and severe severities.|Days 0-7 post each vaccination|||Participants|||Number
731243|NCT00402688|Secondary|Total NIH-CPSI Score|National Institute of Health-Chronic Prostatitis Symptom Index numerically rates a total score (0-43) where 0 indicates no symptoms across any of the domains (pain or discomfort, urination, quality of life).|Screening/Admission, On-Therapy, Week 3, Week 4, Posttherapy (Study Day 33-36)|Modified Intent to Treat (mITT)||Score on a scale||Full Range|Mean
731247|NCT00402688|Secondary|Symptom Relief (Resolved)|Participants With Resolution of Prostatitis Signs and Symptoms; Resolution is defined as symptoms present (mild, moderate or severe) at Screening/Admission and absent (none) at the Posttherapy evaluation.|Posttherapy Visit (Study Day 33-36)|Modified Intent to Treat (mITT)||Participants|||Number
731251|NCT00402727|Secondary|Percentage of Participants With Bacteriological Success (BS) After 14 – 28 Days After Last Dose of Study Medication in the Microbiological Valid (MBV) Population|BS is presumed eradication or eradication without recurrence, super- or reinfection. Presumed eradication was defined as clinical cure in absence of a culture, eradication as a negative culture, recurrence as reappearance of organism present at start of study; super-, reinfection as appearance of a new organism during/after treatment.|14 - 28 days after last dose of study medication|Microbiologically valid subjects were defined as all valid PP subjects in whom at least one causative organism could be cultured from an appropriate specimen within 48 hours prior to or following randomization and where a bacteriological evaluation at TOC visit was available and different from “indeterminate”.||percentage of participants|||Number
731252|NCT00402727|Secondary|Percentage of Participants With Bacteriological Success (BS) After 14 – 28 Days After Last Dose of Study Medication in the ITT Population With Causative Organisms|BS is presumed eradication or eradication without recurrence, super- or reinfection. Presumed eradication was defined as clinical cure in absence of a culture, eradication as a negative culture, recurrence as reappearance of organism present at start of study; super-, reinfection as appearance of a new organism during/after treatment.|14 - 28 days after last dose of study medication|The ITT population with causative organism population included all ITT subjects with least one causative organism that could be cultured from an appropriate specimen within 48 hours prior to or following randomization.||percentage of participants|||Number
731253|NCT00402727|Secondary|Percentage of Participants With Bacteriological Success (BS) After 7 – 21 Days of Treatment in the Microbiological Valid (MBV) Population|Bacteriological success is presumed eradication or eradication without recurrence or superinfection. Presumed eradication was defined as clinical cure in absence of a culture, eradication as a negative culture, recurrence as reappearance of organism present at start of study, superinfection as appearance of a new organism.|after 7 - 21 days of treatment|Microbiologically valid subjects were defined as all valid PP subjects in whom at least one causative organism could be cultured from an appropriate specimen within 48 hours prior to or following randomization and where a bacteriological evaluation at TOC visit was available and different from “indeterminate”.||percentage of participants|||Number
731254|NCT00402727|Secondary|Percentage of Participants With Bacteriological Success (BS) After 7 – 21 Days of Treatment in the ITT Population With Causative Organisms|Bacteriological success is presumed eradication or eradication without recurrence or superinfection. Presumed eradication was defined as clinical cure in absence of a culture, eradication as a negative culture, recurrence as reappearance of organism present at start of study, superinfection as appearance of a new organism.|after 7 - 21 days of treatment|The ITT population with causative organism population included all ITT subjects with least one causative organism that could be cultured from an appropriate specimen within 48 hours prior to or following randomization.||percentage of participants|||Number
731255|NCT00402727|Secondary|Percentage of Participants With Bacteriological Success (BS) at 3 to 5 Days After Start of Treatment in the Microbiological Valid (MBV) Population|Bacteriological success was defined as presumed eradication or eradication without superinfection. Presumed eradication was defined as clinical cure in absence of a culture, eradication as a negative culture, superinfection as appearance of a new organism.|3 - 5 days after start of treatment|Microbiologically valid subjects were defined as all valid PP subjects in whom at least one causative organism could be cultured from an appropriate specimen within 48 hours prior to or following randomization and where a bacteriological evaluation at TOC visit was available and different from “indeterminate”.||percentage of participants|||Number
731256|NCT00402727|Secondary|Percentage of Participants With Bacteriological Success (BS) at 3 to 5 Days After Start of Treatment in the ITT Population With Causative Organisms|Bacteriological success was defined as presumed eradication or eradication without superinfection. Presumed eradication was defined as clinical cure in absence of a culture, eradication as a negative culture, superinfection as appearance of a new organism.|3 - 5 days after start of treatment|The ITT population with causative organism population included all ITT subjects with least one causative organism that could be cultured from an appropriate specimen within 48 hours prior to or following randomization.||percentage of participants|||Number
731257|NCT00402727|Secondary|Percentage of Participants Assessed as Resolution by the Data Review Committee (DRC) at End of Therapy in the Intent to Treat (ITT) Population|Clinical response was evaluated by the investigator and graded as “resolution”, or “failure to respond,” or “indeterminate” at the end of therapy based on subject data for clinical signs and symptoms at each visit, concomitant medication, microbiology results, laboratory tests and interpretation of photographs.|after 7 - 21 days of treatment|The intent-to-treat population was the analysis set used for the assessment of clinical response and was defined as those subject with no major protocol deviations that would have influenced the secondary outcome.||percentage of participants|||Number
731258|NCT00402727|Secondary|Percentage of Participants Assessed as Resolution by the Data Review Committee (DRC) at End of Therapy in the Per Protocol (PP) Population|Clinical response was evaluated by the investigator and graded as “resolution,” or “failure to respond,” or “indeterminate” at the end of therapy based on subject data for clinical signs and symptoms at each visit, concomitant medication, microbiology results, laboratory tests and interpretation of photographs.|after 7 - 21 days of treatment|The per protocol population was the main analysis set for the assessment of clinical response and was defined as those subject with no major protocol deviations that would have influenced the primary outcome.||percentage of participants|||Number
731259|NCT00402727|Secondary|Percentage of Participants Assessed as Improvements by the Data Review Committee (DRC) at the During Treatment Day 3-5 in the Intent to Treat (ITT) Population|Clinical response was evaluated by the investigator and graded as “improvement in signs and symptoms,” or “failure to respond,” or “indeterminate” at Day 3 to 5 after treatment start based on subject data for clinical signs and symptoms at each visit, concomitant medication, microbiology results, laboratory tests and interpretation of photographs|3 - 5 days after start of treatment|The intent-to-treat population was the analysis set used for the assessment of clinical response and was defined as those subject with no major protocol deviations that would have influenced the secondary outcome.||percentage of participants|||Number
731278|NCT00395291|Secondary|Change in IL-1 After 30 Days of Intervention Compared to Baseline Level.|Looking for a change in the IL-1 levels after the subject has been on intervention for 30 days compared to baseline levels.|Baseline and after 30 days of intervention|22 subjects had samples available for the MK-0677 intervention, and 21 samples were available for the placebo intervention.||pg/ml||Standard Deviation|Mean
731260|NCT00402727|Secondary|Percentage of Participants Assessed as Improvements by the Data Review Committee (DRC) at the During Treatment Day 3-5 in the Per Protocol (PP) Population|Clinical response was evaluated by the investigator and graded as “improvement in signs and symptoms,” or “failure to respond,” or “indeterminate” at Day 3 to 5 after treatment start based on subject data for clinical signs and symptoms at each visit, concomitant medication, microbiology results, laboratory tests and interpretation of photographs.|3 - 5 days after start of treatment|The per protocol population was the main analysis set for the assessment of clinical response and was defined as those subject with no major protocol deviations that would have influenced the primary outcome.||percentage of participants|||Number
731261|NCT00402727|Secondary|Percentage of Cured Participants as Determined by the Data Review Committee (DRC) at Test of Cure Visit in the Intent to Treat (ITT) Population|Clinical response was evaluated by the DRC and graded as “cure”, “failure” or “indeterminate” at the TOC visit. Members of the DRC were provided with subject data from the study database that included clinical signs and symptoms at each visit, concomitant medication, microbiology results, laboratory tests and interpretation of photographs.|14 - 28 days after last dose of study medication|The intent-to-treat population was the analysis set used for the assessment of clinical response and was defined as all randomized subject that received at least one dose of study medication and had at least one observation after intake of study drug.||percentage of participants|||Number
731262|NCT00402727|Primary|Percentage of Cured Participants as Determined by the Data Review Committee (DRC) at Test of Cure Visit in the Per Protocol (PP) Population|Clinical response was evaluated by the DRC and graded as “cure”, “failure” or “indeterminate” at the TOC visit. Members of the DRC were provided with subject data from the study database that included clinical signs and symptoms at each visit, concomitant medication, microbiology results, laboratory tests and interpretation of photographs.|14 - 28 days after last dose of study medication|The per protocol population was the main analysis set for the assessment of clinical response and was defined as those subject with no major protocol deviations that would have influenced the primary outcome.||percentage of participants|||Number
731263|NCT00402740|Secondary|Kapan-Meier Estimate of Freedom From Clinically Driven Target Lesion Revascularization Through Three Years.||3 years|ITT||Event-free percentage|||Number
731264|NCT00402740|Secondary|Composite of Any Transient Ischemic Attack (TIA) and Amaurosis Fugax|Includes only each subject's first occurrence of each event.|≤30 days|ITT||percentage of participants||95% Confidence Interval|Number
731265|NCT00402740|Secondary|Procedural Success|Defined as the attainment of less than 50% residual stenosis (per angiographic core lab) of the target lesion and the absence of DSMI at 30 days post-index procedure.|30 Days|ITT||percentage of participants||95% Confidence Interval|Number
731266|NCT00402740|Secondary|Acute Device Success|Defined by the attainment of <50% residual stenosis covering an area no longer than the original lesion treated with the stent.|Post-procedure|ITT||percentage of participants||95% Confidence Interval|Number
731267|NCT00402740|Primary|Kaplan-Meier Estimate of Freedom From the Composite of Any Death, Stroke and MI During the 30 Day Post Procedural Period (DSMI), Plus Fatal and Non-fatal Ipsilateral Stroke From 31-365 Days and Annually Thereafter for a Total of 3 Years.|Freedom from DSMI to 30 days or ipsilateral stroke from 31 days to 3 years. KM event free (%) curve.|3 years|Intent to Treat (ITT)||Event-free percentage|||Number
731268|NCT00402883|Secondary|Overall Survival||18 months||||||
731269|NCT00402883|Secondary|To Evaluate the Objective Response Rates||18 months||||||
731270|NCT00402883|Primary|Time to Progression||18 months|No patients were analyzed due to the fact that the study ended early because of the formation of tracheoesophageal fistulas.|||||
731271|NCT00402896|Primary|Median Time to Pleurodesis|Time to pleurodesis from initiation of treatment to catheter removal as measure of pleural effusion Improvement (amount of pleural fluid drainage) where objective was to examine whether ZD6474 would help participants to improve the condition of pleural effusion, and thus remove the catheter earlier. Cox model analysis applied to examine the effect of covariates on the time to catheter removal.|Time from initiation of treatment and catheter insertion up to a maximum of 10 weeks|Twenty eligible participants were analyzed for the primary outcome in the trial, eleven completed 10 weeks of treatment. All twenty participants completed the study.||Days||95% Confidence Interval|Median
731272|NCT00395226|Primary|Severity of Facial Rosacea After 90 Days of Treatment|Modified Rosacea Severity Scoring System evaluating four signs of rosacea, flushing (transient erythema or redness), erythema (redness), papules and pustules and telangiectasia (spider-veins) ranges from 0 (best, absent) to 12 (worst, severe on all items)|90 days|||units on scale 0 to 12||95% Confidence Interval|Mean
731273|NCT00395291|Secondary|Change in Ghrelin After 30 Days of Intervention Compared to Baseline Level.|Looking for a change in the Ghrelin levels after the subject has been on intervention for 30 days compared to baseline levels.|Baseline and after 30 days of intervention|22 subjects completed both interventions and lab results were available for all 22.||pg/ml||Standard Deviation|Mean
731274|NCT00395291|Secondary|Change in Adiponectin After 30 Days of Intervention Compared to Baseline Level.|Looking for a change in the Adiponectin levels after the subject has been on intervention for 30 days compared to baseline levels.|Baseline and after 30 days of intervention|22 subjects had samples available for the MK-0677 intervention, and 21 samples were available for the placebo intervention.||ng/ml||Standard Deviation|Mean
731275|NCT00395291|Secondary|Change in Esterase After 30 Days of Intervention Compared to Baseline Level.|Looking for a change in the Esterase levels after the subject has been on intervention for 30 days compared to baseline levels.|Baseline and after 30 days of intervention|22 subjects completed both interventions and results were available.||units/ml||Standard Deviation|Mean
731276|NCT00395291|Secondary|Change in IL-10 After 30 Days of Intervention Compared to Baseline Level.|Looking for a change in the IL-10 levels after the subject has been on intervention for 30 days compared to baseline levels.|Baseline and after 30 days of intervention|22 subjects had samples available for the MK-0677 intervention, and 21 samples were available for the placebo intervention.||pg/ml||Standard Deviation|Mean
731277|NCT00395291|Secondary|Changes in the Following Level: IL-6|Change in IL-6 after 30 days of intervention.|After the subject has comleted their last visit|22 subjects had samples available for the MK-0677 intervention, and 21 samples were available for the placebo intervention.||pg/mL||Standard Deviation|Mean
731279|NCT00395291|Secondary|Change in CRPs After 30 Days of Intervention Compared to Baseline Level.|Looking for a change in the CRPs levels after the subject has been on intervention for 30 days compared to baseline levels.|Baseline and after 30 days of intervention|22 Subjects completed both interventions.||mg/ml||Standard Deviation|Mean
731280|NCT00395291|Secondary|Change in TNF-alpha After 30 Days of Intervention Compared to Baseline Level.|Looking for a change in the TNF-alpha levels after the subject has been on intervention for 30 days compared to baseline levels.|Baseline and after 30 days of intervention|22 subjects had samples available for the MK-0677 intervention, and 21 samples were available for the placebo intervention.||pg/ml||Standard Deviation|Mean
731281|NCT00395291|Secondary|Change in Des-Acyl Ghrelin After 30 Days of Intervention Compared to Baseline Level.|Looking for a change in the Des-Acyl Ghrelin levels after the subject has been on intervention for 30 days compared to baseline levels.|Baseline and after 30 days of intervention|22 Subjects completed both interventions.||pg/ml||Standard Deviation|Mean
731282|NCT00395291|Secondary|Change in Insulin After 30 Days of Intervention Compared to Baseline Level.|Looking for a change in the Insulin levels after the subject has been on intervention for 30 days compared to baseline levels.|Baseline and after 30 days of intervention|22 subjects completed both interventions.||uIU/ml||Standard Deviation|Mean
731283|NCT00395291|Secondary|Change in Leptin After 30 Days of Intervention Compared to Baseline Level.|Looking for a change in the Leptin levels after the subject has been on intervention for 30 days compared to baseline levels.|Baseline and after 30 days of intervention|22 subjects completed both interventions.||ng/ml||Standard Deviation|Mean
731284|NCT00395291|Secondary|Change in Acyl-Ghrelin After 30 Days of Intervention Compared to Baseline Level.|Looking for a change in the Acyl-Ghrelin levels after the subject has been on intervention for 30 days compared to baseline levels.|Baseline and after 30 days of intervention.|22 subjects completed both interventions.||pg/ml||Standard Deviation|Mean
731285|NCT00395291|Primary|Change in IGF-1 After 30 Days of Intervention Compared to Baseline Level.|Looking for a change in the IGF-1 levels after the subject has been on intervention for 30 days compared to baseline levels.|Baseline and after 30 days of intervention|22 Subjects completed both interventions and lab results were available.||ng/ml||Standard Deviation|Mean
731286|NCT00395304|Secondary|Adverse Events||Measured during each 16-week treatment period||||||
731287|NCT00395304|Secondary|Time Until First Asthma Exacerbation||Measured during the last 12 weeks of each 16-week treatment period||||||
731288|NCT00395304|Secondary|Asthma Quality of Life||Measured during the last 12 weeks of each 16-week treatment period||||||
731289|NCT00395304|Secondary|Asthma Control Test||Measured during the last 12 weeks of each 16-week treatment period||||||
731290|NCT00395304|Secondary|Exhaled Nitric Oxide||Measured during the last 12 weeks of each 16-week treatment period||||||
731291|NCT00395304|Secondary|Methacholine PC20||Measured during the last 12 weeks of each 16-week treatment period||||||
731292|NCT00395304|Secondary|Impulse Oscillometry||Measured during the last 12 weeks of each 16-week treatment period||||||
731293|NCT00395304|Secondary|PEFR Variability||Measured during the last 12 weeks of each 16-week treatment period||||||
731294|NCT00395304|Secondary|Evening PEFR||Measured during the last 12 weeks of each 16-week treatment period||||||
731295|NCT00395304|Secondary|Morning Peak Expiratory Flow Rate (PEFR)||Measured during the last 12 weeks of each 16-week treatment period||||||
731296|NCT00395304|Secondary|FEV1/FVC||Measured during the last 12 weeks of each 16-week treatment period||||||
731297|NCT00395304|Secondary|Forced Vital Capacity (FVC)||Measured during the last 12 weeks of each 16-week treatment period||||||
731298|NCT00395304|Secondary|Post-bronchodilator Forced FEV1||Measured during the last 12 weeks of each 16-week treatment period||||||
731299|NCT00395304|Secondary|Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1)||Measured during the last 12 weeks of each 16-week treatment period||||||
731300|NCT00395304|Primary|The Number of Participants With a Differential Response to the Three Step-up Therapies Based on Fixed Threshold Criteria for the Following Three Asthma Control Measures: Use of Oral Prednisone for Acute Asthma Exacerbations, Asthma Control Days and FEV1.|One treatment period was ranked as better than another if the total amount of prednisone received during the period was at least 180 mg less, if the number of annualized asthma-control days during the final 12 weeks of the period was increased by at least 31 days, or if the FEV1 at the end of the period was at least 5% higher. If the prednisone threshold was met, then we ignored the number of asthmacontrol days and the FEV1. If the threshold for asthma-control days was met, then we ignored the FEV1. Otherwise, the order of response was determined by the FEV1.|Measured during the last 12 weeks of each 16-week treatment period|ITT. Although only 157 participants completed all three treatment periods, there was sufficient data on 8 additional participants to include them in the analysis of the primary outcome.||Participants|||Number
731301|NCT00395343|Other Pre-specified|Change From Baseline in A1C at Week 24|"A1C in subset of patients on long-acting or intermediate-acting insulin.
A1C is measured as a percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent."|Baseline and Week 24|The Full Analysis Set (FAS) included the subset of patients on long-acting or intermediate-acting insulin with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last non-baseline observed measurement was carried forward to Week 24.||Percent||95% Confidence Interval|Least Squares Mean
731302|NCT00395343|Secondary|Percent of Patients With A1C < 6.5% at Week 24||Week 24|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last non-baseline observed measurement was carried forward to Week 24.||Percent|||Number
731303|NCT00395343|Secondary|Percent of Patients With A1C < 7.0% at Week 24||24 Weeks|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last non-baseline observed measurement was carried forward to Week 24.||Percent|||Number
731613|NCT00405288|Primary|Birth-weight|Weight of the baby measured in grams at time of birth.|until delivery|Estimated number of 200 patients per arm, to detect significant difference of 200g in birth weight at a power of 80% and alpha of 5%. Seven pairs of twin pregnancies were excluded from the comparison of birth weight.||grams||Standard Deviation|Mean
731304|NCT00395343|Secondary|Percent Change From Baseline in Index of Static Beta-Cell Sensitivity to Glucose at Week 24|Static sensitivity is a measure of the effect of glucose on beta-cell secretion and is the ratio between the insulin secretion rate and glucose concentration above the threshold level at steady state. (See Breda and Cobelli, Annals of Biomedical Engineering 29, 692-700 (2001) for more details.)|Baseline and Week 24|The Full Analysis Set (FAS) included all patients who participated in the 10-point meal tolerance test and had a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last non-baseline observed measurement was carried forward to Week 24.||Percent||95% Confidence Interval|Least Squares Mean
731305|NCT00395343|Secondary|Change From Baseline in 2-hour Post-meal Glucose (PMG) at Week 24|Change from baseline at Week 24 is defined as Week 24 minus Week 0.|Baseline and Week 24|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last non-baseline observed measurement was carried forward to Week 24.||mg/dL||95% Confidence Interval|Least Squares Mean
731306|NCT00395343|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Change from baseline at Week 24 is defined as Week 24 minus Week 0.|Baseline and Week 24|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last non-baseline observed measurement was carried forward to Week 24.||mg/dL||95% Confidence Interval|Least Squares Mean
731307|NCT00395343|Primary|Change From Baseline in A1C at Week 24|A1C is measured as a percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.|Baseline and Week 24|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last non-baseline observed measurement was carried forward to Week 24.||Percent||95% Confidence Interval|Least Squares Mean
731308|NCT00395447|Primary|Percentage of Subjects Experiencing a Complication During Generator Replacement Without a Planned Lead Revision or Addition (Straight-forward Device Replacment) or With a Planned Lead Revision or Addition (Planned System Modification)|The percentage of subjects experiencing one of the pre-defined complications is presented. The percentage of subjects experincing a complication is presented separately for subjects with a straight-forward device replacment (generator replacement procedure plan did not include a lead addition or revision) and subjects with a planned system modification (generator replacement procedure plan did include a lead addition or revision).|6 months|||Percentage of participants (%)||95% Confidence Interval|Mean
731309|NCT00395460|Other Pre-specified|Change in Number of Detected Lesions From Pre- to Post-contrast MRI Scan of Participants With CNS Lesions Other Than Primary Malignant Brain Tumor(s) / Brain Metastases|Investigators and blinded readers (reader 2, 3 and 4= were to record the number of lesions in the magnetic resonance scans before and after injection of contrast agent.|Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)|Per Protocol Set (PPS): All patients who have received contrast injection and are not invalid cases. Subgroup: participants with CNS lesions other than primary malignant brain tumor(s) / brain metastases||Lesions||Standard Deviation|Mean
731310|NCT00395460|Other Pre-specified|Change in Number of Detected Lesions From Pre- to Post-contrast MRI Scan of CNS Lesions in Participants With Malignant Brain Tumor(s) / Brain Metastases|Investigators and blinded readers (reader 2, 3 and 4) were to record the number of lesions in the magnetic resonance scans before and after injection of contrast agent.|Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)|Per Protocol Set (PPS): All patients who have received contrast injection and are not invalid cases. Subgroup: participants with primary malignant brain tumor(s) / brain metastases||Lesions||Standard Deviation|Mean
731311|NCT00395460|Other Pre-specified|Change in Contrast to Noise Ratio (CNR) Between Pre- and Post-contrast MRI Scan of Participants With CNS Lesions Other Than Primary Malignant Brain Tumor(s) / Brain Metastases|CNR = (SI lesion – SI normal tissue) / SD background. SI lesion is the signal intensity in the lesion, SI normal tissue is the signal intensity in the normal tissue, and SD background is the standard deviation of the background noise. The signal intensity (SI) on the pre-contrast and on the post-contrast MR scans was to be measured in the enhanced lesion, normal tissue and background.|Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)|Per Protocol Set (PPS): All valid case participants who received contrast injection. Subgroup: those with CNS lesions other than primary malignant brain tumor(s) / brain metastases. 1 (Gadavist) and 2 participants (Magnevist) had missing values for signal intensity for CNS lesions pre- and post-contrast and could not be considered for evaluation.||Contrast to Noise ratio||Standard Deviation|Mean
731312|NCT00395460|Other Pre-specified|Change in Contrast to Noise Ratio (CNR) Between Pre- and Post-contrast MRI Scan of CNS Lesions in Participants With Malignant Brain Tumor(s) / Brain Metastases|CNR = (SI lesion – SI normal tissue) / SD background. SI lesion is the signal intensity in the lesion, SI normal tissue is the signal intensity in the normal tissue, and SD background is the standard deviation of the background noise. The signal intensity (SI) on the pre-contrast and on the post-contrast MR scans was to be measured in the enhanced lesion, normal tissue and background.|Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)|Per Protocol Set (PPS): All valid case participants who received contrast injection. Subgroup: those with primary malignant brain tumor(s) / brain metastases. One participant in the Gadavist group had missing values for signal intensity for central nervous system lesions at pre- and post-contrast and could thus not be considered for evaluation.||Contrast to Noise ratio||Standard Deviation|Mean
731330|NCT00395512|Secondary|Change From Baseline in Mean HDL Particle Size|Change from Baseline in mean HDL particle size was assessed by NMR lipid fractionation at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline mean HDL particle size as a covariate.|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||nm||Standard Error|Least Squares Mean
731496|NCT00402987|Secondary|Sore Throat Relief Rating Scale (STRRS) Within 6 Hours Post-First Dose|STRRS score (scale: 0 no relief to 6 complete relief); a higher pain score indicated a greater reduction in pain.|within the first 6 hours|"Subjects evaluated at each timepoint varied from: 90-85 for 50mg/50mg; 90-87 for 100mg (pooled); 89-85 for Placebo.
MITT population"||scores on a scale||Standard Error|Least Squares Mean
731313|NCT00395460|Secondary|Change in Lesion Delineation Between Pre- and Post-contrast MRI Scan of CNS Lesions|Lesion delineation was recorded on a 4-point scale as follows: 1 = None: no or unclear delineation of the boundary between lesion and surrounding tissue; 2 = Moderate: some aspects of border delineation covered; 3 = Good: almost clear delineation, but not complete on relevant slices; 4 = Excellent: sharp and complete delineation. In case of more than one lesion, the lesion with maximum enhancement was assessed. Change in lesion delineation was assessed based on post-contrast in comparison to pre-contrast scans for investigators and all 3 blinded readers (reader 2, reader 3 and reader 4).|Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)|Per Protocol Set (PPS): All patients who have received contrast injection and are not invalid cases. Lesion contrast enhancement of 1 participant in the Gadavist group was assessed by the investigator (but not the blinded readers) as 'not applicable'.||Lesion delineation score||Standard Deviation|Mean
731314|NCT00395460|Secondary|Change in Lesion Contrast Enhancement From Pre- to Post-contrast MRI|The degree of contrast enhancement was recorded on a 4-point scale as follows: 1 = No: lesion is not enhanced. 2 = Moderate: lesion is weakly enhanced. 3 = Good: lesion is clearly enhanced. 4 = Excellent: lesion is clearly and brightly enhanced. In case of more than one lesion, the lesion with maximum enhancement was to be assessed. The change in lesion contrast enhancement was assessed based on post-contrast in comparison to pre-contrast scans for the investigators and all 3 blinded readers (reader 2, reader 3 and reader 4).|Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)|Per Protocol Set (PPS): All patients who have received contrast injection and are not invalid cases. Lesion contrast enhancement of 1 participant in the Gadavist group was assessed by the investigator (but not the blinded readers) as 'not applicable'.||Contrast enhancement score||Standard Deviation|Mean
731315|NCT00395460|Secondary|Change in Diagnostic Confidence From Pre- to Post-contrast Magnetic Resonance Imaging by Treatment|The change in diagnostic confidence was assessed based on post-contrast compared to pre-contrast scans as “improved”, “unchanged” or “worsened” for the investigators and all 3 blinded readers (reader 2, reader 3 and reader 4).|Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)|Per Protocol Set (PPS): All patients who have received contrast injection and are not invalid cases.||Participants|||Number
731316|NCT00395460|Secondary|Change in Number of Detected Lesions From Pre- to Post-contrast MRI Scan|The number of lesions in the magnetic resonance scans was recorded before and after injection of contrast agent for the investigators and all 3 blinded readers (reader 2, reader 3 and reader 4).|Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)|Per Protocol Set (PPS): All patients who have received contrast injection and are not invalid cases||Lesions||Standard Deviation|Mean
731317|NCT00395460|Primary|Change in Contrast to Noise Ratio (CNR) Between Pre- and Post-contrast Magnetic Resonance Imaging (MRI) Scan of Central Nervous System (CNS) Lesions|CNR = (signal intensity [SI] lesion – SI normal tissue) / standard deviation (SD) background. SI lesion is the signal intensity in the lesion, SI normal tissue is the signal intensity in the normal tissue, and SD background is the standard deviation of the background noise. The signal intensity (SI) on the pre-contrast and on the post-contrast MR scans was to be measured in the enhanced lesion, normal tissue and background.|Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)|Per Protocol Set (PPS): All patients who have received contrast injection and are not invalid cases. Two participants in each treatment group had missing values for signal intensity for central nervous system lesions at pre- and post-contrast and could thus not be considered for evaluation.||Contrast to Noise ratio||Standard Deviation|Mean
731318|NCT00395486|Secondary|Percentage Change of Apolipoprotein B (ApoB)|Calculate the percentage change of apolipoprotein B|Baseline and 6 weeks|||percentage change||Standard Deviation|Mean
731319|NCT00395486|Secondary|Percentage Change of Apolipoprotein A1 (ApoA1)|Calculate the percentage change of Apolipoprotein A1|Baseline and 6 weeks|||percentage change||Standard Deviation|Mean
731320|NCT00395486|Secondary|Percentage Change of Triglycerides (TG)|Calculate the percentage change of Triglycerides.|Baseline and 6 weeks|||percentage change||Standard Deviation|Mean
731321|NCT00395486|Secondary|Percentage Change of High-Density Lipoprotein-C (HDL-C)|Calculate the percentage change of HDL-C level|Baseline and 6 weeks|||percentage change||Standard Deviation|Mean
731322|NCT00395486|Secondary|Percentage Change of Total Cholesterol (TC)|Calculate the percentage change of total cholesterol level|Baseline and 6 weeks|||percentage change||Standard Deviation|Mean
731323|NCT00395486|Secondary|Percentage Reduction of Low-Density Lipoprotein-C (LDL-C)|Calculate the percentage reduction of LDL-C|Baseline and 6 weeks|||percentage reduction||Standard Deviation|Mean
731324|NCT00395486|Secondary|Percentage Change of Insulin Resistance Using QUICKI|QUICKI was calculated using insulin and glucose levels derived by laboratory test. The formula is as following: QUICKI = 1/[log(insulin) + log(glucose)].|Baseline and 6 weeks|||percentage change||Standard Deviation|Mean
731325|NCT00395486|Secondary|Percentage Change of Insulin Resistance Using HOMA-R|HOMA-R was calculated using insulin and glucose levels derived by laboratory test. The formula is as following: HOMA-R = insulin* glucose/22.5|Baseline and 6 weeks|||percentage change||Standard Deviation|Mean
731326|NCT00395486|Secondary|Percentage Change of Glucose Level|Using laboratory test, mean change of glucose level was investigated.|Baseline and 6 weeks|||Percentage change||Standard Deviation|Mean
731327|NCT00395486|Secondary|Percentage of Subjects Reaching Their Low-Density Lipoprotein-C (LDL-C) and Non High-Density Lipoprotein-C (HDL-C) Target Goal|Based on NCEP ATP III guideline, calculate the percentage of subjects reaching their LDL-C & non HDL-C target goal.|Baseline and 6 weeks|||percentage of participants|||Number
731328|NCT00395486|Secondary|Percentage of Subjects Reaching Their LDL-C Target Goal|Based on NCEP ATP III guideline, calculate the percentage of subjects reaching their LDL-C target goal. LDL-C target goals are <70mg/dl, <100mg/dl and <130mg/dl according to their baseline conditions (presence of Coronary heart disease and risk factors and grade of Framingham 10-Year risk).|Baseline and 6 weeks|||percentage of participants|||Number
731329|NCT00395486|Primary|Percentage Change From Baseline in Ratio of Apolipoprotein (ApoB/ApoA1) at Week 6|Samples for evaluation from all investigational sites will be delivered by courier to the central laboratory within 24 hours of blood being drawn. This outcome will be calculated by using the result of ApoB and ApoA1.|Baseline and 6 weeks|||percent change||Standard Deviation|Mean
733707|NCT00422097|Secondary|Maximum Plasma Concentration (Cmax) of Ixabepilone||Days 1 and 5 of Cycle 1|All participants who received ixabepilone and who had adequate concentration profiles||ng/mL||Standard Deviation|Mean
731331|NCT00395512|Secondary|Change From Baseline in High Density Lipoprotein (HDL) Particles|"The change from Baseline in levels of total, large, medium and small HDL particles was assessed by NMR fractionation at Weeks 12 and 26.
Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline HDL particles as a covariate."|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||µmol/L||Standard Error|Least Squares Mean
731332|NCT00395512|Secondary|Change From Baseline in Mean LDL Particle Size|Change from Baseline in mean LDL particle size was assessed by NMR lipid fractionation at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline mean LDL particle size as a covariate.|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||nm||Standard Error|Least Squares Mean
731333|NCT00395512|Secondary|Change From Baseline in Low Density Lipoprotein (LDL) Particles|"The change from Baseline in levels of total, large, medium-small, total small and very small LDL particles was assessed by NMR fractionation at Weeks 12 and 26.
Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline LDL particles as a covariate."|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||nmol/L||Standard Error|Least Squares Mean
731334|NCT00395512|Secondary|Change From Baseline in Intermediate Density Lipoprotein (IDL) Particles|"The change from Baseline in levels of IDL particles was assessed by NMR fractionation at Weeks 12 and 26.
Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline IDL particles as a covariate."|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||nmol/L||Standard Error|Least Squares Mean
731335|NCT00395512|Secondary|Change From Baseline in Mean VLDL Particle Size|Change from Baseline in mean VLDL particle size was assessed by NMR lipid fractionation at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline mean VLDL particle size as a covariate.|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||nm||Standard Error|Least Squares Mean
731336|NCT00395512|Secondary|Change From Baseline in VLDL Particles|"The change from Baseline in levels of medium VLDL particles and small VLDL particles was assessed by NMR fractionation at Weeks 12 and 26.
Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline VLDL particles as a covariate."|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||nmol/L||Standard Error|Least Squares Mean
731337|NCT00395512|Secondary|Change From Baseline in VLDL / Chylomicron Triglycerides|"The change from Baseline in levels of VLDL/chylomicron triglycerides was assessed by NMR lipid fractionation at Weeks 12 and 26.
Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline VLDL/chylomicron triglycerides as a covariate."|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
731338|NCT00395512|Secondary|Change From Baseline in Very Low Density Lipoprotein (VLDL) / Chylomicron Particles|"The change from Baseline in levels of total VLDL/chylomicron particles and large VLDL/chylomicron particles was assessed by NMR lipid fractionation at Weeks 12 and 26.
Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline VLDL/chylomicron particles as a covariate."|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||nmol/L||Standard Error|Least Squares Mean
731339|NCT00395512|Secondary|Change From Baseline in Nuclear Magnetic Resonance Lipid Fractionation Total Triglycerides|Nuclear Magnetic Resonance (NMR) lipid fractionation was used to assess the change from Baseline in total triglyceride levels at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline NMR total triglycerides as a covariate.|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
731340|NCT00395512|Secondary|Change From Baseline in Apolipoprotein C-III|Change from Baseline in apolipoprotein C-III was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline apolipoprotein C-III as a covariate.|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
731341|NCT00395512|Secondary|Change From Baseline in Apolipoprotein B|Change from Baseline in apolipoprotein B was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline apolipoprotein B as a covariate.|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
731342|NCT00395512|Secondary|Change From Baseline in Apolipoprotein A2|Change from Baseline in apolipoprotein A2 was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline apolipoprotein A2 as a covariate.|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
731343|NCT00395512|Secondary|Change From Baseline in Apolipoprotein A1|Change from Baseline in Apolipoprotein A1 was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and Baseline apolipoprotein A1 as a covariate.|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
731344|NCT00395512|Secondary|Change From Baseline in Adiponectin|Change from Baseline in adiponectin was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline adiponectin as a covariate.|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||μg/mL||Standard Error|Least Squares Mean
731345|NCT00395512|Secondary|Change From Baseline in High-sensitivity C-Reactive Protein|Change from Baseline in high-sensitivity C-Reactive Protein (hsCRP) was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline hsCRP as a covariate.|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||mg/L||Standard Error|Least Squares Mean
731346|NCT00395512|Secondary|Change From Baseline in Plasminogen Activator Inhibitor-1|Change from Baseline in plasminogen activator inhibitor-1 was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline plasminogen activator inhibitor-1 as a covariate.|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||ng/mL||Standard Error|Least Squares Mean
731347|NCT00395512|Secondary|Change From Baseline in Free Fatty Acids|Change from Baseline in free fatty acids (FFA) was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline free fatty acid as a covariate.|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||mmol/L||Standard Error|Least Squares Mean
731348|NCT00395512|Secondary|Change From Baseline in Triglyceride Levels|Change from Baseline in triglycerides was assessed at Weeks 4, 8, 12, 16, 20 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline triglycerides as a covariate.|Baseline and Weeks 4, 8, 12, 16, 20 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
731349|NCT00395512|Secondary|Change From Baseline in High-Density Lipoprotein Cholesterol|Change from Baseline in high-density lipoprotein cholesterol (HDL-C) was assessed at Weeks 4, 8, 12, 16, 20 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline HDL cholesterol as a covariate.|Baseline and Weeks 4, 8, 12, 16, 20 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
731350|NCT00395512|Secondary|Change From Baseline in Low-Density Lipoprotein Cholesterol|Change from Baseline in low-density lipoprotein cholesterol (LDL-C) was assessed at Weeks 4, 8, 12, 16, 20 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline LDL cholesterol as a covariate.|Baseline and Weeks 4, 8, 12, 16, 20 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
731351|NCT00395512|Secondary|Change From Baseline in Total Cholesterol Level|Change from Baseline in total cholesterol level was assessed at Weeks 4, 8, 12, 16, 20 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline total cholesterol as a covariate.|Baseline and Weeks 4, 8, 12, 16, 20 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
731352|NCT00395512|Secondary|Change From Baseline in Body Weight|Change from Baseline in body weight was assessed at Weeks 8, 12, 20 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and Baseline weight as a covariate.|Baseline and Weeks 8, 12, 20 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||kg||Standard Error|Least Squares Mean
731353|NCT00395512|Secondary|Change From Baseline in Homeostatic Model Assessment Beta Cell Function|"The Homeostasis Model Assessment (HOMA) estimates steady state beta cell function (%B) as a percentage of a normal reference population.
HOMA %B = 20 * insulin (µIU/mL) / fasting plasma glucose (mmol/L) - 3.5
The change from Baseline in the homeostasis model assessment of beta cell function was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline HOMA beta cell function as a covariate."|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||percentage beta cell function||Standard Error|Least Squares Mean
731354|NCT00395512|Secondary|Change From Baseline in Calculated Homeostatic Model Assessment Insulin Resistance|"The Homeostasis Model Assessment of insulin resistance (HOMA IR) measures insulin resistance based on fasting glucose and insulin measurements:
HOMA IR = fasting plasma insulin (µIU/mL) * fasting plasma glucose (mmol/L) / 22.5
A higher number indicates a greater degree of insulin resistance. The change from Baseline in HOMA IR was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline HOMA IR as a covariate."|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||insulin resistance||Standard Error|Least Squares Mean
731355|NCT00395512|Secondary|Change From Baseline in C-peptide Levels|C-peptide is a byproduct created when the hormone insulin is produced and is measured by a blood test. Change from Baseline was assessed at Weeks 4, 8, 12, 16, 20 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline C-peptide as a covariate.|Baseline and Weeks 4, 8, 12, 16, 20 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||ng/mL||Standard Error|Least Squares Mean
731512|NCT00403273|Secondary|Number of Participants With Occurrence of Joint Erythema, Warmth, Swelling or Tenderness|Occurence of any of the above clinical features (erythema, warmth, swelling or tenderness) as a new finding compared to the absence of the same feature at baseline|Upto 6 months|patients providing data||participants|||Number
731356|NCT00395512|Secondary|Change From Baseline in Proinsulin/Insulin Ratio|The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (μIU/mL) at weeks 4, 8, 12, 16, 20 and 26 relative to the Baseline value. Least squares means were from an ANCOVA model with treatment and geographic region as class variables and Baseline proinsulin/insulin ratio as a covariate.|Baseline and Weeks 4, 8, 12, 16, 20 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||ratio||Standard Error|Least Squares Mean
731357|NCT00395512|Secondary|Change From Baseline in Insulin|The change from Baseline in fasting insulin was assessed at Weeks 4, 8, 12, 16, 20 and 26. Least Squares Means were from an ANCOVA model with treatment and geographic region as class variables and baseline insulin as a covariate.|Baseline and Weeks 4, 8, 12, 16, 20 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||μIU/mL||Standard Error|Least Squares Mean
731358|NCT00395512|Secondary|Change From Baseline in Fasting Proinsulin|Proinsulin is a precursor to insulin, and was measured as an indicator of pancreatic function. The change from Baseline in fasting proinsulin was assessed at Weeks 4, 8, 12, 16, 20 and 26. Least Squares Means were from an ANCOVA model with treatment and geographic region as class variables and baseline proinsulin as a covariate.|Baseline and Weeks 4, 8, 12, 16, 20 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||pmol/L||Standard Error|Least Squares Mean
731359|NCT00395512|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin Greater Than or Equal to 2.0%|Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of ≥ 2.0%.|Baseline and Week 26|Full Analysis Set. Participants who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.||percentage of participants|||Number
731360|NCT00395512|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin Greater Than or Equal to 1.5%.|Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of ≥ 1.5%.|Baseline and Week 26|Full Analysis Set. Participants who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.||percentage of participants|||Number
731361|NCT00395512|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin Greater Than or Equal to 1.0%|Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of ≥ 1%.|Baseline and Week 26|Full Analysis Set. Participants who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.||percentage of participants|||Number
731362|NCT00395512|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin Greater Than or Equal to 0.5%|Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of ≥ 0.5%.|Baseline and Week 26|Full Analysis Set. Participants who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.||percentage of participants|||Number
731363|NCT00395512|Secondary|Percentage of Participants With Glycosylated Hemoglobin Less Than or Equal to 7.5%|Clinical response at Week 26 was assessed by the percentage of participants with HbA1c ≤ 7.5%.|Week 26|Full Analysis Set. Participants who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.||percentage of participants|||Number
731364|NCT00395512|Secondary|Percentage of Participants With Glycosylated Hemoglobin Less Than or Equal to 7.0%|Clinical response at Week 26 was assessed by the percentage of participants with HbA1c ≤ 7%.|Week 26|Full Analysis Set. Participants who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.||percentage of participants|||Number
731365|NCT00395512|Secondary|Percentage of Participants With Glycosylated Hemoglobin Less Than or Equal to 6.5%|Clinical response at Week 26 was assessed by the percentage of participants with HbA1c ≤6.5%.|Week 26|Full Analysis Set. Participants who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.||percentage of participants|||Number
731366|NCT00395512|Secondary|Percentage of Participants Meeting Rescue Criteria|"Rescue was defined as meeting 1 of the following criteria, confirmed by a 2nd sample drawn within 5 days after the first sample and analyzed by the central laboratory:
After more than 4 weeks of treatment but prior to the Week 8 Visit: a single fasting plasma glucose ≥310 mg/dL (≥17.5 mmol/L);
From the Week 8 Visit but prior to the Week 12 Visit: a single fasting plasma glucose ≥275 mg/dL (≥15.27 mmol/L);
From the Week 12 Visit through the End-of-Treatment Visit: HbA1c ≥8.5% and ≤0.5% reduction in HbA1c as compared with the Baseline HbA1c."|Weeks 4, 8, 12, 16, 20 and 26.|Full analysis set including patients with visits during or after the specified interval in each treatment group.||percentage of participants|||Number
731367|NCT00395512|Secondary|Percentage of Participants With Marked Hyperglycemia|Marked Hyperglycemia is defined as fasting plasma glucose greater than or equal to 200 mg/dL. Study week windows are defined to place hyperglycemia into visit categories.|Weeks 1, 2, 4, 8, 12, 16, 20 and 26.|Full analysis set including patients with at least one non-missing fasting plasma glucose result in the specified interval in each treatment group.||percentage of participants|||Number
731368|NCT00395512|Secondary|Change From Baseline in Fasting Plasma Glucose Over Time|The change from Baseline in fasting plasma glucose was assessed at weeks 1, 2, 4, 8, 12, 16, 20 and 26. Least Squares Means were from an ANCOVA model with treatment and geographic region as class variables and baseline plasma glucose as a covariate.|Baseline and Weeks 1, 2, 4, 8, 12, 16, 20 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
731369|NCT00395512|Secondary|Change From Baseline in HbA1c Over Time|The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at 4 week intervals during the study. Least Squares Means were from an Analysis of Covariance (ANCOVA) model with treatment and geographic region as class variables and baseline HbA1c as a covariate.|Baseline and Weeks 4, 8, 12, 16 and 20.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
731370|NCT00395512|Primary|Change From Baseline to Week 26 in Glycosylated Hemoglobin (HbA1c)|The change from Baseline to Week 26 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound).|Baseline and Week 26|The Full analysis Set (all randomized patients who took at least 1 dose of double-blind study drug) where a Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
731371|NCT00395629|Secondary|Trough Concentrations of Deferasirox (ICL670), by Dose Cohort (Per-protocol Population)|A blood sample was collected just prior to administration of the next dose of Deferasirox (pre-dose trough level) or approximately 24 hours after the previous dose at weeks 4, 8, 12, 16, 20 and 24. The mean trough concentration at each time point was calculated.|4, 8, 12, 16, 20, and 24 weeks|Per-protocol population included all participants of the safety population; who received at least one dose of study drug within the core study and had at least one safety assessment, and who did not have any major protocol deviation. n in each of the Categories is the number of participants in each arm/group who had data for that time point.||µmol/L||Standard Deviation|Mean
731372|NCT00395629|Primary|Absolute Change of Serum Ferritin From Baseline to the End of Extension, by Dose Cohort (Extension Per-protocol Population)|Mean absolute change in serum ferritin from baseline to the end of the extension study.|0 to 48 weeks|Extension Per-protocol population including all participants of the per protocol population who also were part of the extension safety population.||µg/L||Standard Deviation|Mean
731373|NCT00395642|Primary|Patient Compliance of Weight and Blood Pressure External Monitoring and Home Monitoring Transmissions. Percentage of Days Transmitted.|Analyzed transmission periods for weight, blood pressure (BP) and Home Monitoring (HM) started with the respective first transmission. In patients where neither system transmitted data, the date of enrollment was taken as the start date of the analyzed period for all systems. If only one remote system transmitted data (e.g. HM or weight and BP data only), the first transmission date from the corresponding, successfully transmitting system was assumed as the start date of the analyzed period for the non-transmitting system. Analyzed transmission period ended with study exit or completion.|6 months|All Enrolled Participants||Percent of days|||Number
731374|NCT00395694|Secondary|Percentage of Participants With Monocyte Values Outside the Normal Range (Shifted High) at Weeks 4 and 8|Monocytes are a type of white blood cell (WBC; typically comprising 2%-8% of total WBCs) and are a part of the immune system. The normal range for adults is 0.2 to 0.95 * 10^3 cells per microliter (µL); the normal range for adolescents is 0 to 0.8 * 10^3 cells per µL. The monocyte count may increase during chronic inflammation, stress response, immune-mediated disease, viral fever, etc. The percentage of participants (par.) with monocyte values outside the normal range was calculated as 100 * (number of par. with monocyte values outside the normal range) divided by the total number of par.|Week 4 and Week 8|Safety Population||percentage of participants|||Number
731375|NCT00395694|Secondary|Number of Rash Events (Including SJS and Any Other Serious Drug Eruption) Adjudicated by the Rash Adjudication Committee in Participants Taking VPA|The rash adjudication committee reviewed all rash events from a dermatologic standpoint based on the nature, onset site, affected area, time to onset, outcome, and the investigator's comments to adjudicate whether or not the reported event was a drug eruption. A drug eruption is an eruption or a solitary lesion caused by a drug taken internally, often a result of allergic sensitization.|Up to Week 8 of the Maintenance Phase (Study Week 14)|Safety Population. Only those participants who had experienced any rash event were evaluated.||adjudicated rash events|Participants||Number
731376|NCT00395694|Secondary|Number of Drug-related and Not Related Rash Events (Including SJS and Any Other Serious Drug Eruption) up to the End of the Maintenance Phase|"The adverse event of rash was considered to be drug-related when the Investigator answered Yes to the following question: Is there a reasonable possibility that the adverse event may have been caused by the investigational product?."|Up to Week 8 of the Maintenance Phase (Study Week 14)|Safety Population. Only those participants who had experienced any rash event were evaluated.||rash events|||Number
731377|NCT00395694|Secondary|Number of Participants With the Indicated Intensity of Rash (Including SJS and Any Other Serious Drug Eruption) up to the End of the Maintenance Phase|The rash events (including SJS and any other serious drug eruption) were classified into severe (rash prevents participant from leading a normal life), moderate (participant's discomfort due to rash interferes with daily life), and mild (no interference with participant's daily life due to rash), based on the intesity of the event.|Up to Week 8 of the Maintenance Phase (Study Week 14)|Safety Population. Only those participants who had experienced any rash event were evaluated.||participants|||Number
731378|NCT00395694|Secondary|Number of Rash Events Experienced (Including SJS and Any Other Serious Drug Eruption) up to the End of the Maintenance Phase|"Any rash event (including SJS or any other serious drug eruption) includes: all event terms containing rash; drug eruption; SJS; toxic epidermal necrolysis; rash generalized; and events grouped into the Skin and Subcutaneous Tissue Disorders system organ class per the Medical Dictionary for Regulatory Activities (MedDRA), including the above-mentioned events that the GSK medical advisors judged to be included as any rash event. SJS, also called as erythema multiforme, is a skin disorder resulting from an allergic reaction or infection."|Up to Week 8 of the Maintenance Phase (Study Week 14)|Safety Population. Only those participants who had experienced any rash event were evaluated.||rash events|||Number
731379|NCT00395694|Secondary|Number of Participants With Any Rash Event (Including SJS and Any Other Serious Drug Eruption) up to the End of the Maintenance Phase|"Any rash event (including SJS or any other serious drug eruption) includes: all event terms containing rash; drug eruption; SJS; toxic epidermal necrolysis; rash generalized; and events grouped into the Skin and Subcutaneous Tissue Disorders system organ class per the Medical Dictionary for Regulatory Activities (MedDRA), including the above-mentioned events that the GSK medical advisors judged to be included as any rash event. SJS, also called as erythema multiforme, is a skin disorder resulting from an allergic reaction or infection."|Up to Week 8 of the Maintenance Phase (Study Week 14)|Safety Population||participants|||Number
731417|NCT00395863|Secondary|Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 2|Change from predose to postdose in lesion-to-brain ratio computed. Comparison of the differences in change were analyzed.|Predose and immediately postdose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. Lesion-level analysis.||[ratio]|Participants|Standard Deviation|Mean
731380|NCT00395694|Secondary|Percent Change in Seizure Frequency of the Indicated Types of Seizures|Percent change in seizure frequency was calculated as 100 * (pre-treatment seizures minus MP seizures)/pre-treatment seizures. Partial seizures are seizures that affect only a part of the brain at onset. Tonic-clonic seizures (grand mal seizures) affect the entire brain and are characterized by a generalized involuntary muscular contraction and cessation of respiration followed by tonic and clonic spasms of the muscles. Lennox-Gastaut syndrome (LGS) is a pediatric epilepsy syndrome characterized by multiple seizure types, mental retardation or regression, and abnormal findings on an ECG.|Pre-treatment (Day 0) and Week 8 of the Maintenance Phase (Study Week 14)|FAS Population||percent change||95% Confidence Interval|Median
731381|NCT00395694|Secondary|Percentage of Participants With at Least a 50 Percent Reduction in Seizure Frequency for the Indicated Types of Seizures|Partial seizures are seizures that affect only a part of the brain at onset. Tonic-clonic seizures (grand mal seizures) affect the entire brain and are characterized by a generalized involuntary muscular contraction and cessation of respiration followed by tonic and clonic spasms of the muscles. Lennox-Gastaut syndrome (LGS) is a pediatric epilepsy syndrome characterized by multiple seizure types; mental retardation or regression; and abnormal findings on an electroencephalogram (EEG), with paroxysms of fast activity and generalized slow spike-and-wave discharges.|8 weeks|Full Analysis Set (FAS) Population: all enrolled participants except those who had no assessments of the main efficacy variable (percent reduction in seizure frequency).||percentage of participants|||Number
731382|NCT00395694|Secondary|Number of Drug-related and Not Related Rash Events (Including SJS and Any Other Serious Drug Eruption) During the Initial 8 Weeks of Study Treatment|"The adverse event of rash was considered to be drug-related when the Investigator answered Yes to the following question: Is there a reasonable possibility that the adverse event may have been caused by the investigational product?."|8 weeks|Safety Population. Only those participants who had experienced any rash event were evaluated.||rash events|||Number
731383|NCT00395694|Secondary|Number of Participants With the Indicated Intensity of Rash (Including SJS and Any Other Serious Drug Eruption) During the Initial 8 Weeks of Study Treatment|The rash events (including SJS and any other serious drug eruption) were classified into severe (rash prevents participant from leading a normal life), moderate (participant's discomfort due to rash interferes with daily life), and mild (no interference with participant's daily life due to rash), based on the intesity of the event.|8 weeks|Safety Population. Only those participants who had experienced any rash event were evaluated.||participants|||Number
731384|NCT00395694|Secondary|Number of Rash Events Experienced (Including SJS and Any Other Serious Drug Eruption) During the Initial 8 Weeks of Study Treatment|"Any rash event (including SJS or any other serious drug eruption) includes: all event terms containing rash; drug eruption; SJS; toxic epidermal necrolysis; rash generalized; and events grouped into the Skin and Subcutaneous Tissue Disorders system organ class per the Medical Dictionary for Regulatory Activities (MedDRA), including the above-mentioned events that the GSK medical advisors judged to be included as any rash event. SJS, also called as erythema multiforme, is a skin disorder resulting from an allergic reaction or infection."|8 weeks|Safety Population. Only those participants who had experienced any rash event were evaluated.||rash events|||Number
731385|NCT00395694|Primary|Number of Participants With Any Rash Event (Including Stevens–Johnson Syndrome [SJS] and Any Other Serious Drug Eruption) During the Initial 8 Weeks of Study Treatment|"Any rash event (including SJS or any other serious drug eruption) includes: all event terms containing rash; drug eruption; SJS; toxic epidermal necrolysis; rash generalized; and events grouped into the Skin and Subcutaneous Tissue Disorders system organ class per the Medical Dictionary for Regulatory Activities (MedDRA), including the above-mentioned events that the GSK medical advisors judged to be included as any rash event. SJS, also called as erythema multiforme, is a skin disorder resulting from an allergic reaction or infection."|8 weeks|Safety Population: all participants enrolled in the study who received at least one dose of study medication||participants|||Number
731386|NCT00395733|Secondary|MRA Diagnosis by Blinded Reader 3|The MRA diagnosis describes the pathology with regard to the extent of a stenosis, i.e., normal (no relevant disease), advanced arteriosclerosis but stenosis <= 50% (exemption: internal carotid artery: stenosis <= 70%), advanced arteriosclerosis, stenosis >50% but <99% (stenosis 50-99%) (exemption: internal carotid artery >70%), occlusion, and not assessable.|20-30 seconds after injection|Per Protocol Set (PPS): All participants who have received contrast injection and are not invalid cases. Note: The contrast enhanced MR image from one participant was lost after assessment by the investigator, i.e. the PPS analysis for the blinded readers is based on the images of 66 participants only.||Vessels|||Number
731387|NCT00395733|Secondary|MRA Diagnosis by Blinded Reader 2|The MRA diagnosis describes the pathology with regard to the extent of a stenosis, i.e., normal (no relevant disease), advanced arteriosclerosis but stenosis <= 50% (exemption: internal carotid artery: stenosis <= 70%), advanced arteriosclerosis, stenosis >50% but <99% (stenosis 50-99%) (exemption: internal carotid artery >70%), occlusion, and not assessable.|20-30 seconds after injection|Per Protocol Set (PPS): All participants who have received contrast injection and are not invalid cases. Note: The contrast enhanced MR image from one participant was lost after assessment by the investigator, i.e. the PPS analysis for the blinded readers is based on the images of 66 participants only.||Vessels|||Number
731388|NCT00395733|Secondary|MRA Diagnosis by Blinded Reader 1|The MRA diagnosis describes the pathology with regard to the extent of a stenosis, i.e., normal (no relevant disease), advanced arteriosclerosis but stenosis <= 50% (exemption: internal carotid artery: stenosis <= 70%), advanced arteriosclerosis, stenosis >50% but <99% (stenosis 50-99%) (exemption: internal carotid artery >70%), occlusion, and not assessable.|20-30 seconds after injection|Per Protocol Set (PPS): All participants who have received contrast injection and are not invalid cases. Note: The contrast enhanced MR image from one participant was lost after assessment by the investigator, i.e. the PPS analysis for the blinded readers is based on the images of 66 participants only.||Vessels|||Number
731389|NCT00395733|Secondary|MRA Diagnosis by Investigators|The MRA diagnosis describes the pathology with regard to the extent of a stenosis, i.e., normal (no relevant disease), advanced arteriosclerosis but stenosis <= 50% (exemption: internal carotid artery: stenosis <= 70%), advanced arteriosclerosis, stenosis >50% but <99% (stenosis 50-99%) (exemption: internal carotid artery >70%), occlusion, and not assessable.|20-30 seconds after injection|Per Protocol Set (PPS): All participants who have received contrast injection and are not invalid cases.||Vessels|||Number
731390|NCT00395733|Secondary|Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 3|Independent blinded reader 3 assessed the change in diagnostic confidence in the assessment of MRA scans before and after injection with Gadavist and Magnevist for each participant on a three-point scale as improved, unchanged or worsened.|immediately before and 20-30 seconds after injection (precontrast and postcontrast)|Per Protocol Set (PPS): All participants who have received contrast injection and are not invalid cases. Note: The contrast enhanced MR image from one participant was lost after assessment by the investigator, i.e. the PPS analysis for the blinded readers is based on the images of 66 participants only.||Participants|||Number
731391|NCT00395733|Secondary|Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 2|Independent blinded reader 2 assessed the change in diagnostic confidence in the assessment of MRA scans before and after injection with Gadavist and Magnevist for each participant on a three-point scale as improved, unchanged or worsened.|immediately before and 20-30 seconds after injection (precontrast and postcontrast)|Per Protocol Set (PPS): All participants who have received contrast injection and are not invalid cases. Note: The contrast enhanced MR image from one participant was lost after assessment by the investigator, i.e. the PPS analysis for the blinded readers is based on the images of 66 participants only.||Participants|||Number
731392|NCT00395733|Secondary|Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 1|Independent blinded reader 1 assessed the change in diagnostic confidence in the assessment of MRA scans before and after injection with Gadavist and Magnevist for each participant on a three-point scale as improved, unchanged or worsened.|immediately before and 20-30 seconds after injection (precontrast and postcontrast)|Per Protocol Set (PPS): All participants who have received contrast injection and are not invalid cases. Note: The contrast enhanced MR image from one participant was lost after assessment by the investigator, i.e. the PPS analysis for the blinded readers is based on the images of 66 participants only.||Participants|||Number
731393|NCT00395733|Secondary|Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Investigator|The on-site investigators assessed the change in diagnostic confidence in the assessment of MRA scans before and after injection with Gadavist and Magnevist for each participant on a three-point scale as improved, unchanged or worsened.|immediately before and 20-30 seconds after injection (precontrast and postcontrast)|Per Protocol Set (PPS): All participants who have received contrast injection and are not invalid cases.||Participants|||Number
731394|NCT00395733|Primary|Number of Vessel Segments Visualized With Diagnostic Quality|Each arterial segment visualized in magnetic resonance angiography (MRA) enhanced by Gadavist and Magnevist was characterized by the on-site investigators and by three independent blinded readers (reader 1, 2 and 3) according to a five-point scale (none/not assessable, poor, moderate, good, excellent), which takes into consideration intravascular contrast quality as well as vessel border delineation. The number of vessel segments with adequate diagnostic quality, i.e. good or excellent scores, was determined for each MRA image.|20-30 seconds after injection|Per Protocol Set (PPS): All participants who have received contrast injection and are not invalid cases. Note: The contrast enhanced MR image from one participant was lost after assessment by the investigator, i.e. the PPS analysis for the blinded readers is based on the images of 66 participants only.||vessel segments||Standard Deviation|Mean
731395|NCT00395746|Secondary|Hypoglycaemic Episodes|Hypoglycaemic episodes measured over 52 weeks of treatment. Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|over 52 weeks of treatment|Full Analysis Set (FAS) consists of all subjects who received at least one dose of study drug.||number of events per year of exposure|||Number
731396|NCT00395746|Secondary|Body Weight After 52 Weeks of Treatment||after 52 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.||kg||Standard Error|Least Squares Mean
731397|NCT00395746|Secondary|Body Weight After 24 Weeks of Treatment||after 24 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.||kg||Standard Error|Least Squares Mean
731398|NCT00395746|Secondary|Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 52 Weeks of Treatment|Mean postprandial plasma glucose (PG) increment in 7-point plasma glucose profile, ie the mean of the difference of plasma glucose measured before and after a meal, after 52 weeks of treatment. The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime.|after 52 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.||mg/dL||Standard Error|Least Squares Mean
731399|NCT00395746|Secondary|Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 24 Weeks of Treatment|Mean postprandial plasma glucose (PG) increment in 7-point plasma glucose profile, ie the mean of the difference of plasma glucose measured before and after a meal, after 24 weeks of treatment. The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime.|after 24 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.||mg/dL||Standard Error|Least Squares Mean
731400|NCT00395746|Secondary|Mean PG in 7-point Plasma Glucose Profile After 52 Weeks of Treatment|7-point plasma glucose (PG) profile measured after 52 weeks of treatment. The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime.|after 52 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.||mg/dL||Standard Error|Least Squares Mean
731401|NCT00395746|Secondary|Mean PG in 7-point Plasma Glucose Profile After 24 Weeks of Treatment|Plasma glucose (PG) profile measured after 24 weeks of treatment. The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime.|after 24 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.||mg/dL||Standard Error|Least Squares Mean
731402|NCT00395746|Secondary|Postprandial Glucose AUC After 52 Weeks of Treatment|Postprandial Glucose AUC measured 0-3 hours after a meal after 52 weeks of treatment|after 52 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.||mg/dL *h||Standard Error|Least Squares Mean
731403|NCT00395746|Secondary|Postprandial Glucose AUC After 24 Weeks of Treatment|Postprandial glucose AUC measured 0-3 hours after a meal after 24 weeks of treatment|after 24 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.||mg/dL *h||Standard Error|Least Squares Mean
731404|NCT00395746|Secondary|Fasting Plasma Glucose After 52 Weeks of Treatment||after 52 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.||mg/dL||Standard Error|Least Squares Mean
731405|NCT00395746|Secondary|Fasting Plasma Glucose After 24 Weeks of Treatment||after 24 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.||mg/dL||Standard Error|Least Squares Mean
731406|NCT00395746|Secondary|Glycosylated Haemoglobin A1c (HbA1c) After 52 Weeks of Treatment||after 52 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.||percentage of total haemoglobin||Standard Error|Least Squares Mean
731407|NCT00395746|Primary|Glycosylated Haemoglobin A1c (HbA1c) After 24 Weeks of Treatment||after 24 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.||percentage of total haemoglobin||Standard Error|Least Squares Mean
731408|NCT00395850|Secondary|Retention||14 weeks|those who were entered the disulfiram phase,e tc.||Weeks||Standard Deviation|Mean
731409|NCT00395850|Primary|Cocaine Use Over Time|Urine toxicology results (dichotomous: positive or negative) for the presence of cocaine/cocaine metabolite during the disulfiram phase of the study. The change in the probability of a cocaine positive urine sample per day was assessed for each dose compared with placebo and slopes for each dose condition were calculated from Repeated Measures Genearlized Linear Models on a Binomial distribution (thus a Repeated Measures Logistic Regression)|thrice weekly for 12 weeks|number is based on those who participated long enough to have assessments completed at two time points during the disulfiram phase||slope (change in prob of coc-pos utox/d)|||Number
731410|NCT00395863|Secondary|Percentage of Contrast Enhancement of the Lesion - Reader 3|Quantitative parameter derived from signal intensity (SI) measurements. LCE ([SI of lesion (postdose)-SI of lesion (predose)]/Standard SI of lesion (predose)]|Postdose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. Lesion-level analysis.||[percent]|Participants|Standard Deviation|Mean
731411|NCT00395863|Secondary|Percentage of Contrast Enhancement of the Lesion - Reader 2|Quantitative parameter derived from signal intensity (SI) measurements. LCE ([SI of lesion (postdose)-SI of lesion (predose)]/Standard SI of lesion (predose)]|Postdose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. Lesion-level analysis.||[percent]|Participants|Standard Deviation|Mean
731412|NCT00395863|Secondary|Percentage of Contrast Enhancement of the Lesion - Reader 1|Quantitative parameter derived from signal intensity (SI) measurements. LCE ([SI of lesion (postdose)-SI of lesion (predose)]/Standard SI of lesion (predose)]|Postdose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. Lesion-level analysis.||[percent]|Participants|Standard Deviation|Mean
731413|NCT00395863|Secondary|Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 3|Change from predose to postdose in contrast-to-noise ratio computed. Comparison of the differences in change were analyzed.|Predose and immediately postdose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. Lesion-level analysis.||[ratio]|Participants|Standard Deviation|Mean
731414|NCT00395863|Secondary|Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 2|Change from predose to postdose in contrast-to-noise ratio computed. Comparison of the differences in change were analyzed.|Predose and immediately postdose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. Lesion-level analysis.||[ratio]|Participants|Standard Deviation|Mean
731415|NCT00395863|Secondary|Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 1|Change from predose to postdose in contrast-to-noise ratio computed. Comparison of the differences in change were analyzed.|Predose and immediately postdose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. Lesion-level analysis.||[ratio]|Participants|Standard Deviation|Mean
731416|NCT00395863|Secondary|Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 3|Change from predose to postdose in lesion-to-brain ratio computed. Comparison of the differences in change were analyzed.|Predose and immediately postdose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. Lesion-level analysis.||[ratio]|Participants|Standard Deviation|Mean
731493|NCT00402987|Secondary|Sore Throat Relief Rating Scale (STRRS) - ‘Moderate Relief’ at 12 Hours Post-First Dose|Subjects Achieving at Least ‘Moderate Relief’ as Measured by STRRS (range: 0=no relief to 6=complete relief); Moderate relief is defined as STRRS = 3).|12 hours|MITT population||subjects|||Number
731418|NCT00395863|Secondary|Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 1|Change from predose to postdose in lesion-to-brain ratio computed. Comparison of the differences in change were analyzed.|Predose and immediately postdose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. Lesion-level analysis.||[ratio]|Participants|Standard Deviation|Mean
731419|NCT00395863|Secondary|Lesion Contrast Enhancement Between the Two Exams|Assessed by 3 blinded Readers for each of the 41 patients who had both MultiHance and Magnevist post dose MRI exam to assess whether the image with MultiHance was preferreed, both contrast agents were equal, or the image with Magnevist was preferred.|Postdose Images for MultiHance Exam and for Magnevist Exam Compared|Include all ITT population. The number of units analyzed is the total number of technically adequate postdose images assessed by the reader from the total number of participants with both MultiHance- and Magnevist-enhanced images. Patient-level analysis.||Contrast-enhanced Images|Participants||Number
731420|NCT00395863|Secondary|Lesion Border Delineation|Assessed by 3 blinded Readers for each of the 41 patients who had both MultiHance and Magnevist post dose MRI exam to assess whether the image with MultiHance was preferreed, both contrast agents were equal, or the image with Magnevist was preferred.|Postdose Images for MultiHance Exam and for Magnevist Exam Compared|Include all ITT population. The number of units analyzed is the total number of technically adequate postdose images assessed by the reader from the total number of participants with both MultiHance- and Magnevist-enhanced images. Patient-level analysis.||Contrast-enhanced Images|Participants||Number
731421|NCT00395863|Primary|Global Diagnostic Preference Between the Two Exams|Assessed by 3 blinded Readers for each of the 41 patients who had both MultiHance and Magnevist post dose MRI exam to assess whether the image with MultiHance was preferreed, both contrast agents were equal, or the image with Magnevist was preferred.|Postdose Images for MultiHance Exam and for Magnevist Exam Compared|Include all ITT population. The number of units analyzed is the total number of technically adequate postdose images assessed by the reader from the total number of participants with both MultiHance- and Magnevist-enhanced images. Patient-level analysis.||Contrast-enhanced Images|Participants||Number
731422|NCT00395876|Secondary|Percentage of Patients Who Had Restoration of CVC Function at Any Time During the Study and Who Maintained Catheter Patency the Next Time the Catheter Was Assessed, up to 7 Days Following the Last Dose of Tenecteplase|Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|Up to 7 days post-treatment|Number of patients (from MITT population) with restored CVC function during the treatment period||Percentage of patients||95% Confidence Interval|Number
731423|NCT00395876|Secondary|Percentage of Patients Who Had Restoration of CVC Function Following Administration of One or Two Doses of Tenecteplase|Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|Up to 120 minutes post-treatment|Modified intent to treat (MITT) population||percentage of participants||95% Confidence Interval|Number
731424|NCT00395876|Secondary|Percentage of Patients Who Had Restoration of CVC Function Following a Third Administration of Study Drug|Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|120 minutes after third dose|Modified intent to treat (MITT) population||Percentage of patients||95% Confidence Interval|Number
731425|NCT00395876|Secondary|Percentage of Patients Who Had Restoration of CVC Function Following a Third Administration of Study Drug|Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|30 minutes after third dose|Modified intent to treat (MITT) population||Percentage of patients||95% Confidence Interval|Number
731426|NCT00395876|Secondary|Percentage of Patients Who Had Restoration of CVC Function Following a Third Administration of Study Drug|Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|15 minutes after third dose|Modified intent to treat (MITT) population||percentage of participants||95% Confidence Interval|Number
731427|NCT00395876|Secondary|Percentage of Patients Who Had Restoration of CVC Function Following a Second Administration of Study Drug|Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|120 minutes after second dose|Modified intent to treat (MITT) population||Percentage of patients||95% Confidence Interval|Number
731428|NCT00395876|Secondary|Percentage of Patients Who Had Restoration of CVC Function Following a Second Administration of Study Drug|Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|30 minutes after second dose|Modified intent to treat (MITT) population||Percentage of patients||95% Confidence Interval|Number
731429|NCT00395876|Secondary|Percentage of Patients Who Had Restoration of CVC Function Following a Second Administration of Study Drug|Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|15 minutes after second dose|Modified intent to treat (MITT) population||percentage of participants||95% Confidence Interval|Number
731430|NCT00395876|Secondary|Percentage of Patients Who Had Restoration of CVC Function Following a Single Administration of Study Drug|Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|30 minutes after first dose|Modified intent to treat (MITT) population||Percentage of patients|||Number
731431|NCT00395876|Secondary|Percentage of Patients Who Had Restoration of CVC Function Following a Single Administration of Study Drug|Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|15 minutes after first dose|Modified intent to treat (MITT) population||percentage of participants|||Number
731432|NCT00395876|Primary|Percentage of Patients Who Had Restoration of Central Venous Catheter (CVC) Function Following a Single Administration of Study Drug|Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|120 minutes after first dose|Modified intent to treat (MITT) population||percentage of participants|||Number
731433|NCT00395967|Secondary|Graft Durability at 12 Months After Transplantation|"Participants with durable grafts. Graft durability was assessed by complete blood count (CBC) and differential analysis at 12 months post-transplantation.
This study was terminated early and analysis was not done."|13 months|This study was terminated early and analysis was not done.|||||
731434|NCT00395967|Secondary|Number of Days to Platelet (PLT) Engraftment|"The median number of days to platelet (PLT) engraftment criteria was ≥ 20*10^9/L platelets without transfusion for the preceding 7 days. Time to engraftment corresponded to the first day that criteria were met.
This study was terminated early and analysis was not done."|2 months|This study was terminated early and analysis was not done.|||||
731435|NCT00395967|Secondary|Number of Days to Polymorphonuclear Leukocyte (PMN) Engraftment|"The median number of days to PMN engraftment criteria was PMN counts ≥ 0.5*10^9/L for 3 consecutive days or ≥ 1.0*10^9/L for 1 day. Time to engraftment corresponded to the first day that criteria were met.
This study was terminated early and analysis was not done."|2 months|This study was terminated early and analysis was not done.|||||
731436|NCT00395967|Secondary|The Fold Increase in Peripheral Blood CD34+ Cells Following the First Dose of Plerixafor|"The fold increase was measured by fluorescence activated cell sorting (FACS) analysis and expressed as a ratio. Fold increase = pre-apheresis PB CD34+ cells/µL)/(pre-plerixafor dosing PB CD34+ cells/µL).
This study was terminated early and analysis was not done."|Days 5-6|This study was terminated early and analysis was not done.|||||
731437|NCT00395967|Secondary|Overall Participants Counts of Adverse Events|Numbers of participants with adverse events (AEs) collected from Day 1 (start of G-CSF Mobilization) to 12 months after transplantation. AEs were reported regardless of relationship to study treatment. The investigator graded each AE using the World Health Organization (WHO) Adverse Event Grading Scale and provided assessments of seriousness and relatedness to study treatment.|up to 13 months|Safety Population defined as all participants who received G-CSF and/or plerixafor.||participants|||Number
731438|NCT00395967|Primary|Number of Patients Who Achieved ≥2*10^6 CD34+ Cells/kg Following Treatment With Plerixafor 240 µg/kg and G-CSF for up to 3 Consecutive Days|The number of patients with a circulating CD34+ count >= 5 and < 20 cells/ml after 5 days of mobilization with G-CSF alone who achieved cumulative apheresis yields of ≥2*10^6 CD34+ cells/kg within 3 days of apheresis after receiving G-CSF plus plerixafor. Outcome was based on laboratory results from a central lab.|approximately days 6-9|All patients who received plerixafor.||participants|||Number
731439|NCT00395993|Primary|Number of Subjects Achieving 'Clinical Success'. Clinical Success is Defined as an Increase in Hemoglobin of ≥ 2.0 g/dL||Any time between baseline and the end of study or time to intervention|Modified Intent-to-Treat Population defined as subjects from the Safety Population who received at least 1 dose of study medication, had average baseline hemoglobin, TSAT, and ferritin levels, had heavy uterine bleeding, and had at least 1 post-baseline hemoglobin assessment.||participants|||Number
731452|NCT00396032|Secondary|Percentage of Subjects Who Had Treatment Success With Respect to BFR at Visit 2 (MITT Population With Open-label Tenecteplase at Visit 2)|Treatment success is defined as BFR of ≥300 mL/min and an increase from baseline BFR of ≥25 mL/min at an associated target arterial pressure in the range of 0 to -280 mmHg 30 (±10) minutes prior to the end of HD and at the end of HD.|Visit 2 of consecutive HD treatments|MITT population with open-label tenecteplase at Visit 2||percentage of success|||Number
731453|NCT00396032|Secondary|Percentage of Subjects Who Had Treatment Success With Respect to BFR at Visit 2 (MITT Population With Extended Dwell Tenecteplase at Visit 1)|Treatment success is defined as BFR of ≥300 mL/min and an increase from baseline BFR of ≥25 mL/min at an associated target arterial pressure in the range of 0 to -280 mmHg 30 (±10) minutes prior to the end of HD and at the end of HD.|Visit 2 of consecutive HD treatments|MITT population with extended-dwell tenecteplase at Visit 1||percentage of success|||Number
731454|NCT00396032|Secondary|Change in BFR From Baseline to the End of HD at Visit 1|BFR is measured in mL/minute.|Visit 1 of HD treatment|MITT population||percentage of participants|||Number
731455|NCT00396032|Primary|Incidence of Targeted Adverse Events (AEs) From Initial Study Drug Administration Through the Start of Visit 2|Targeted AEs were intracranial hemorrhages (ICHs), major bleeding, embolic events, thrombosis, catheter-related bloodstream infections (CRBSIs), and catheter related complications|Visits 1 and 2 of consecutive HD treatments|MITT population||percentage of participants|||Number
731456|NCT00396032|Primary|Percentage of Subjects Who Had Treatment Success With Respect to Blood Flow Rate (BFR) at Visit 1|Treatment success is defined as BFR of ≥300 mL/min and an increase from baseline BFR of ≥25 mL/min at an associated target arterial pressure in the range of 0 to -280 mmHg 30 (±10) minutes prior to the end of HD and at the end of HD.|Visit 1 of HD treatment|Modified intent to treat (MITT) population||percentage of success|||Number
731457|NCT00402987|Other Pre-specified|No Perceptible Relief|Subjects having No Perceptible Relief at each time point. No Perceptible relief is score = 0 on Sore Throat Relief Rating Scale (STRRS)(range: 0=no relief to 6=complete relief).|up to 24 hours|"MITT population
Number of subjects at each time point (in hour) is: N = Celecoxib 50mg/50mg, Celecoxib 100mg/Placebo, Celecoxib 100mg/50mg, Placebo"||subjects|||Number
731458|NCT00402987|Other Pre-specified|First Perceptible Relief|Subjects having First Perceptible Relief at each time point. Perceptible relief is score >0 on Sore Throat Relief Rating Scale(STRRS)(range: 0=no relief to 6=complete relief).|up to 24 hours|"MITT population
Number of subjects assessed at each hour is: N = Celecoxib 50mg/50mg, Celecoxib 100mg/Placebo, Celecoxib 100mg/50mg, Placebo"||subjects|||Number
731459|NCT00402987|Other Pre-specified|Treatment Satisfaction Questionnaire for Medication (TSQM vII)|11 questions scored on factors: effectiveness, side effects, convenience, overall satisfaction. TSQM vII scores range 0 to 100, with higher scores indicating a higher level of global satisfaction with treatment.|24 hours or immediately prior to taking rescue medication|MITT population||scores on a scale||Standard Deviation|Mean
731460|NCT00402987|Other Pre-specified|Subjects Taking Rescue Medication|Subjects were allowed to use rescue medication at any time during the trial, but were discouraged from taking rescue medication within 2 hours of administration of the first dose of study drug.|Within 24 hours Post-First Dose|MITT population||subjects|||Number
731461|NCT00402987|Other Pre-specified|Treatment Failures on STRRS Questionnaire|Subjects were considered treatment failures if all of the STRRS scores were less than each individual's 'meaningful relief' scores. STRRS score ranges from 0=no relief to 6=complete relief.|24 hours Post-First Dose|MITT population||subjects|||Number
731462|NCT00402987|Other Pre-specified|Median Offset Time of No Perceptible Relief in Subjects Who Achieved Their Own Level of 'Meaningful Relief' Within 6 Hours Post-First Dose|Offset time is time of first no perceptible relief (STRRS score=0) with meaningful relief (score>0) at earlier time. STRRS score ranges from 0=no relief to 6=complete relief.|24 Hours|Number of subjects who achieved Meaningful Relief within 6 hours||hours||Full Range|Median
731463|NCT00402987|Other Pre-specified|Median Onset Time of First Perceptible Relief in Subjects Who Achieved Their Own Level of 'Meaningful Relief' Within 6 Hours Post-First Dose|Perceptible Relief is score >0 on STRRS. Individual level of meaningful relief had to be reached within 6 hours. Meaningful Relief was achieved if Sore Throat Relief Rating Scale (STRRS)(range: 0=no relief to 6=complete relief)score at the end of the study was the same or higher than individually defined meaningful relief score during the study.|24 Hours|Number of subjects who achieved meaningful relief within 6 hours||hours||Full Range|Median
731464|NCT00402987|Other Pre-specified|Subjects Who Achieved Their Own Level of 'Meaningful Relief' Within 6 Hours Who Still Had Perceptible Relief at 12 and 24 Hours Post-First Dose|At end of study subjects defined meaningful pain relief by completing the Meaningful Relief Scale. Meaningful relief was achieved if Sore Throat Relief Rating Scale (STRRS)(range: 0=no relief to 6=complete relief) score at end of the study was the same or higher than individually defined relief score during the study. Perceptible relief is STRRS >0|12 and 24 hours Post-First Dose|MITT population||subjects|||Number
731494|NCT00402987|Secondary|Sore Throat Relief Rating Scale (STRRS) - ‘Moderate Relief’ at 6 Hours Post-First Dose|Subjects Achieving at Least ‘Moderate Relief’ as Measured by STRRS (range: 0=no relief to 6=complete relief); Moderate relief is defined as STRRS = 3).|at 6 hours|MITT population||subjects|||Number
731465|NCT00402987|Other Pre-specified|Subjects Who Achieved Their Own Level of 'Meaningful Relief' Within 6 Hours Who Had Perceptible Relief Onset Time Within 1 Hour|At end of study subjects defined meaningful pain relief by completing Meaningful Relief Scale. Meaningful relief was achieved if Sore Throat Relief Rating Scale (STRRS) score (range: 0=no relief to 6=complete relief) at end of the study was the same or higher than individually defined relief score during the study. Perceptible relief is STRRS >0.|Within 6 hours Post-First Dose|MITT population||subjects|||Number
731466|NCT00402987|Other Pre-specified|Subjects Who Achieved Their Own Level of 'Meaningful Relief' and 'Much Improvement' at 12 Hours Post-First Dose|Symptom relief measured as self-directed endpoints defined by each individual at end of study using Sore Throat Relief Rating Scale (STRRS); STRRS score ranges from 0=no relief to 6=complete relief. If subject scored same or greater in their STRRS during the study then they achieved their 'Meaningful Relief' or 'Much Improvement'.|12 hours Post-First Dose|MITT population||subjects|||Number
731467|NCT00402987|Other Pre-specified|Subjects Who Achieved Their Own Level of 'Meaningful Relief' and 'Much Improvement' at 2 and 6 Hours Post-First Dose|Symptom relief measured as self-directed endpoints defined by each individual at end of study using Sore Throat Relief Rating Scale (STRRS); STRRS score ranges from 0=no relief to 6=complete relief. If subject scored same or greater in their STRRS during the study then they achieved their 'Meaningful Relief' or 'Much Improvement'.|2 and 6 hours Post-First Dose|MITT population||subjects|||Number
731468|NCT00402987|Other Pre-specified|Subjects With Sore Throat Pain at Least 35% Gone and at Least 50% Gone at 12 Hours Post-First Dose|>= 35% and 50% Pain Intensity Difference (PID) on the Pain Intensity-Visual Analog Scale (PI-VAS) (scale: 0mm=no pain, 100mm=worst possible pain). The PID was calculated as the difference between the pain intensity at 12 hours and at baseline.|12 hours Post-First Dose|MITT population||subjects|||Number
731469|NCT00402987|Other Pre-specified|Subjects With Sore Throat Pain at Least 35% Gone and at Least 50% Gone at 2 and 6 Hours Post-First Dose|>= 35% and 50% Pain Intensity Difference (PID) on the Pain Intensity-Visual Analog Scale (PI-VAS) (scale: 0mm=no pain, 100mm=worst possible pain). The PID was calculated as the difference between the pain intensity at the time and at baseline.|2 and 6 hours Post-First Dose|MITT population||subjects|||Number
731470|NCT00402987|Other Pre-specified|Number Needed to Treat (NNT) to Achieve at Least 50% of Maximum Total Pain Relief (TOTPAR) at 12 Hours Post-First Dose|NNT is number of subjects needed to treat to have one subject report a 50% or better pain relief over 12 hours based on maximum possible pain relief on Sore Throat Relief Rating Scale. Maximum TOTPAR over 12 hours is 72. If the subject TOTPAR is greater than or equal to 50% of the maximum TOTPAR then the subject has achieved >=50% TOTPAR.|12 hours Post-First Dose|MITT population Comparison Celecoxib 100mg/50mg - Placebo: the NNT value was non-estimable||subjects|||Number
731471|NCT00402987|Other Pre-specified|Number Needed to Treat (NNT) to Achieve at Least 50% of Maximum Total Pain Relief (TOTPAR) at 6 Hours Post-First Dose|NNT is number of subjects needed to treat to have one extra subject report a 50% or better pain relief over 6 hours based on maximum possible pain relief on Sore Throat Relief Rating Scale. Maximum TOTPAR over 6 hours is 36. If the subject TOTPAR is greater than or equal to 50% of the maximum TOTPAR then the subject has achieved >=50% TOTPAR.|6 hours Post-First Dose|MITT population||subjects|||Number
731472|NCT00402987|Other Pre-specified|Subjects With >= 50% Total Pain Relief (TOTPAR) at 12 Hours Post-First Dose|TOTPAR is time-interval-weighted sum of accumulated Sore Throat Relief Rating Scale (STRRS) scores (scale: 0 no relief to 6 complete relief). Maximum TOTPAR over 12 hours is 72. If the subject calculated TOTPAR is greater than or equal to 50% of the maximum TOTPAR then the subject is said to have achieved >=50% TOTPAR.|12 hours Post-First Dose|MITT population||subjects|||Number
731473|NCT00402987|Other Pre-specified|Subjects With >= 50% Total Pain Relief (TOTPAR) at 6 Hours Post-First Dose|TOTPAR is time-interval-weighted sum of accumulated Sore Throat Relief Rating Scale (STRRS) scores (scale: 0 no relief to 6 complete relief). Maximum TOTPAR over 6 hours is 36. If the subject calculated TOTPAR is greater than or equal to 50% of the maximum TOTPAR then the subject is said to have achieved >=50% TOTPAR.|6 hours Post-First Dose|MITT population||subjects|||Number
731474|NCT00402987|Other Pre-specified|Total Pain Relief (TOTPAR) at 12 and 24 Hours Post-First Dose|TOTPAR is time-interval-weighted sum of accumulated Sore Throat Relief Rating Scale (STRRS) scores (scale: 0 no relief to 6 complete relief).|12 and 24 hours Post-First Dose|"Subjects evaluated at 24 hours: 84 for 50mg/50mg; 43 for 100mg/Placebo; 44 for 100mg/50mg; 81 for Placebo.
MITT population"||scores on a scale||Standard Error|Least Squares Mean
731475|NCT00402987|Other Pre-specified|Total Pain Relief (TOTPAR) at 2 and 6 Hours Post-First Dose|TOTPAR is time-interval-weighted sum of accumulated Sore Throat Relief Rating Scale (STRRS) scores (scale: 0 no relief to 6 complete relief).|2 and 6 hours Post-First Dose|"Subjects evaluated at 6 hours: 85 for 50mg/50mg; 87 for 100mg (pooled); 85 for Placebo.
MITT population"||scores on a scale||Standard Error|Least Squares Mean
731476|NCT00402987|Other Pre-specified|Difficulty Swallowing Scale (DSS) Difference at Least 50% Gone at 12 Hours Post-First Dose|Number of Subjects with >= 50% Pain Intensity Difference (PID) on the DSS. The Difficulty Swallowing PID was calculated as the difference between the pain intensity (DSS scale: 0mm=not difficult, 100mm=very difficult) at 12 hours and at baseline.|At 12 Hours|MITT population||subjects|||Number
731477|NCT00402987|Other Pre-specified|Difficulty Swallowing Scale (DSS) Difference at Least 50% Gone at 6 Hours Post-First Dose|Number of Subjects with >= 50% Pain Intensity Difference (PID) on the DSS. The Difficulty Swallowing PID was calculated as the difference between the pain intensity (DSS scale: 0mm=not difficult, 100mm=very difficult) at 6 hours and at baseline.|At 6 hours|MITT population||subjects|||Number
731478|NCT00402987|Other Pre-specified|Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose|The sum of pain intensity differences (SPID) was calculated as the AUC of the Pain Intensity Difference (PID) scores. The Difficulty Swallowing PID was calculated as the difference between the pain intensity (DSS range: 0mm=not difficult, 100mm=very difficult) at the time and at baseline.|7 to 24 hours Post-First Dose|"Subjects evaluated at each timepoint varied from: 85-80 for 50mg/50mg; 43-39 for 100mg/Placebo; 44-43 for 100mg/50mg; 82-73 for Placebo.
MITT population"||units on a scale * hours||Standard Error|Least Squares Mean
731495|NCT00402987|Secondary|Sore Throat Relief Rating Scale (STRRS) From 7 to 24 Hours Post-First Dose|STRRS score (scale: 0 no relief to 6 complete relief); a higher score indicated a greater reduction in pain.|7 to 24 hours|"Subjects evaluated at each timepoint varied from: 85-80 for 50mg/50mg; 43-39 for 100mg/Placebo; 44-43 for 100mg/50mg; 82-73 for Placebo.
MITT population"||scores on a scale||Standard Error|Least Squares Mean
731479|NCT00402987|Other Pre-specified|Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose|The sum of pain intensity differences (SPID) was calculated as the AUC of the Pain Intensity Difference (PID) scores. The Difficulty Swallowing PID was calculated as the difference between the pain intensity (DSS range: 0mm=not difficult, 100mm=very difficult) at the time and at baseline.|Within 6 hours Post-First Dose|"Subjects evaluated at each timepoint varied from: 90-85 for 50mg/50mg; 90-87 for 100mg (pooled); 89-85 for Placebo.
MITT population"||units on a scale * hours||Standard Error|Least Squares Mean
731480|NCT00402987|Other Pre-specified|Sum of Sore Throat Pain Intensity Difference (SPID2) as Measured by Difficulty Swallowing Scale (DSS) at 2 Hours Post-First Dose|SPID2 was calculated as the AUC of the Pain Intensity Difference (PID) scores. The Difficulty Swallowing PID was calculated as the difference between the pain intensity (DSS scale: 0mm=not difficult, 100mm=very difficult) at 2 hours post dose and at baseline.|Over 2 hour Period Post-First Dose|MITT population||units on a scale * hours||Standard Error|Least Squares Mean
731481|NCT00402987|Other Pre-specified|Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose|The Difficulty Swallowing Pain Intensity Difference (PID) was calculated as the difference between the pain intensity (DSS range: 0mm=not difficult, 100mm=very difficult) at the time and at baseline.|7 to 24 hours Post-First Dose|"Subjects evaluated at each timepoint varied from: 85-80 for 50mg/50mg; 43-39 for 100mg/Placebo; 44-43 for 100mg/50mg; 82-73 for Placebo.
MITT population"||units on a scale||Standard Error|Least Squares Mean
731482|NCT00402987|Other Pre-specified|Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose|The Difficulty Swallowing Pain Intensity Difference (PID) was calculated as the difference between the pain intensity (DSS range: 0mm=not difficult, 100mm=very difficult) at the time and at baseline.|Within 6 hours Post-First Dose|"Subjects evaluated at each timepoint varied from: 90-85 for 50mg/50mg; 90-87 for 100mg (pooled); 89-85 for Placebo.
MITT population"||units on a scale||Standard Error|Least Squares Mean
731483|NCT00402987|Other Pre-specified|Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) From 7 to 24 Hours Post-First Dose|The sum of sore throat pain intensity differences (SPID) was calculated as the AUC of the Pain Intensity Difference (PID) scores. The Sore Throat PID was calculated as the difference between the pain intensity (TSS range: 0=not sore to 10=very sore) at the time and at baseline.|7 to 24 hours Post-First Dose|"Subjects evaluated at each timepoint varied from: 85-80 for 50mg/50mg; 43-39 for 100mg/Placebo; 44-43 for 100mg/50mg; 82-73 for Placebo.
MITT population"||units on a scale * hours||Standard Error|Least Squares Mean
731484|NCT00402987|Other Pre-specified|Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) Within 6 Hours Post-First Dose|The sum of sore throat pain intensity differences (SPID) was calculated as the AUC of the Pain Intensity Difference (PID) scores. The Sore Throat PID was calculated as the difference between the pain intensity (TSS range: 0=not sore to 10=very sore) at the time and at baseline.|Within 6 hours Post-First Dose|"Subjects evaluated at each timepoint varied from: 90-85 for 50mg/50mg; 90-87 for 100mg (pooled); 89-85 for Placebo.
MITT population
At 15min the SE was <0.01 for all 3 groups"||units on a scale * hours||Standard Error|Least Squares Mean
731485|NCT00402987|Other Pre-specified|Sore Throat Pain Intensity Difference (SPID2) as Measured by Throat Soreness Scale (TSS) at 2 Hours Post-First Dose|SPID2 was calculated as the AUC of the Pain Intensity Difference (PID) scores. The Sore Throat PID was calculated as the difference between the pain intensity (TSS scale: 0=not sore to 10=very sore) at 2 hours post dose and at baseline.|2 hour period Post-First Dose|MITT population||units on a scale * hours||Standard Error|Least Squares Mean
731486|NCT00402987|Other Pre-specified|Throat Soreness Scale (TSS) Difference From 7 to 24 Hours Post-First Dose|The Pain Intensity Difference (PID) based on TSS (scale: 0=not sore to 10=very sore) was calculated as the difference between the pain intensity at the time and at baseline.|7 to 24 hours post-first dose|"Subjects evaluated at each timepoint varied from: 85-80 for 50mg/50mg; 43-39 for 100mg/Placebo; 44-43 for 100mg/50mg; 82-73 for Placebo.
MITT population"||scores on a scale||Standard Error|Least Squares Mean
731487|NCT00402987|Other Pre-specified|Throat Soreness Scale (TSS) Difference Within 6 Hours Post-First Dose|The Pain Intensity Difference (PID) based on TSS (scale: 0=not sore to 10=very sore) was calculated as the difference between the pain intensity at the time and at baseline.|Within first 6 hours post-first dose|"Subjects evaluated at each timepoint varied from: 90-85 for 50mg/50mg; 90-87 for 100mg (pooled); 89-85 for Placebo.
MITT population"||scores on a scale||Standard Error|Least Squares Mean
731488|NCT00402987|Secondary|Patient’s Global Evaluation of Study Medication at 12 and 24 Hours Post-First Dose|Subject assessment of overall impression of study drug on 4 point scale from 1 (poor) to 4 (excellent)|12 and 24 hours Post-First Dose|"Subjects analyzed at 24 hours were different for 2 groups: Celecoxib 100mg/Placebo=45 and Placebo=87.
MITT population"||subjects|||Number
731489|NCT00402987|Secondary|Patient’s Global Evaluation of Study Medication at 6 Hours Post-First Dose|Subject assessment of overall impression of study drug on 4 point scale from 1 (poor) to 4 (excellent)|6 Hours Post-First Dose|MITT population||subjects|||Number
731490|NCT00402987|Secondary|Time to Onset of Analgesia|Equal to time of perceptible pain relief when both perceptible pain relief and meaningful pain relief were experienced- the median time was not estimable thus the number of subjects with onset of analgesia within 2 hours of first dose is reported|Within 2 Hours Post-First Dose|"MITT population.
The median time to onset of analgesia, including all subjects, was >2 hours in each group (time was censored at 2 hours).
Median time and CI were not estimable."||subjects|||Number
731491|NCT00402987|Secondary|Time to Meaningful Pain Relief|The time (measured by stopwatch) when the subject felt their pain relief was meaningful to them was not estimable thus the number of subjects experiencing meaningful pain relief within 2 hours of first dose is reported|Within 2 Hours Post-First Dose|"MITT population.
The median time to meaningful pain relief, including all subjects, was >2 hours in each group (time was censored at 2 hours)
Median time and CI were not estimable"||subjects|||Number
731492|NCT00402987|Secondary|Time to Perceptible Pain Relief|Defined as time (measured by stopwatch) when subject began to feel any pain relieving effect from the drug|Within 2 Hours Post-First Dose|"MITT population.
Number of Subjects achieving perceptible pain relief: 77 for celecoxib 50mg/50mg; 67 for celecoxib 100mg (pooled); 46 for placebo
Upper 95% CI for placebo group was >120"||minutes||95% Confidence Interval|Median
731497|NCT00402987|Secondary|Sum of Sore Throat Pain Intensity Difference (SPID) From 7 to 24 Hours Post-First Dose|The sum of pain intensity differences (SPID) was calculated as the AUC of the Pain Intensity Difference (PID) scores. The PID [based on PI-VAS scale: 0mm=no pain, 100mm=worst possible pain] was calculated as the difference between the pain intensity at the time and at baseline.|7 to 24 hours|"Subjects evaluated at each timepoint varied from: 85-80 for 50mg/50mg; 43-39 for 100mg/Placebo; 44-43 for 100mg/50mg; 82-73 for Placebo.
MITT population"||units on a scale * hours||Standard Error|Least Squares Mean
731498|NCT00402987|Secondary|Sum of Sore Throat Pain Intensity Difference (SPID) Within 6 Hours Post-First Dose|The sum of pain intensity differences (SPID) was calculated as the AUC of the Pain Intensity Difference (PID) scores. The PID [based on PI-VAS scale: 0mm=no pain, 100mm=worst possible pain] was calculated as the difference between the pain intensity at the time and at baseline.|up to 6 hours|"Subjects evaluated at each timepoint varied from: 90-85 for 50mg/50mg; 90-87 for 100mg (pooled); 89-85 for Placebo.
MITT population"||units on a scale * hours||Standard Error|Least Squares Mean
731499|NCT00402987|Secondary|Sore Throat Pain Intensity Difference (PID) From 7 to 24 Hours Post-First Dose|Pain intensity (PI) on Swallowing as Measured by PI-VAS scale: 0mm=no pain, 100mm=worst possible pain. PID score was obtained by subtracting the PI at each time point from the Baseline PI score. An increase in scores indicated a lessening of subjects' pain as compared to Baseline scores, thus, higher scores indicated a greater reduction in pain.|7 to 24 hours|"Subjects evaluated at each timepoint varied from: 85-80 for 50mg/50mg; 43-39 for 100mg/Placebo; 44-43 for 100mg/50mg; 82-73 for Placebo.
MITT population"||units on a scale||Standard Error|Least Squares Mean
731500|NCT00402987|Secondary|Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose|Pain intensity (PI) on Swallowing as Measured by PI-VAS scale: 0mm=no pain, 100mm=worst possible pain. Sore throat PID score was obtained by subtracting the PI at each time point from the Baseline PI score. Increase in scores indicated a lessening of subjects' pain compared to baseline scores; higher scores indicated a greater reduction in pain.|Within First 6 hours Post-First Dose|"Subjects evaluated at each timepoint varied from: 90-85 for 50mg/50mg; 90-87 for 100mg (pooled); 89-85 for Placebo.
MITT population"||units on a scale||Standard Error|Least Squares Mean
731501|NCT00402987|Primary|Sum of Sore Throat Pain Intensity Difference (SPID2) on Swallowing at 2 Hours Post-First Dose|Based on the Pain Intensity scores measured on a Visual Analogue Scale (PI-VAS: 0mm=no pain,100mm=worst possible pain), assessed by the subjects, the SPID2 is the area under the curve (AUC) over the 2-hour period post-first dose of the Pain Intensity Difference (PID) scores using the trapezoidal rule.|2 hours Post-First Dose|Modified intent-to-treat (MITT) population, defined as all subjects randomized to treatment who received at least 1 dose of study drug and had at least 1 post-treatment efficacy assessment. The celecoxib 100mg (pooled) treatment group and placebo were compared for the primary endpoint. Celecoxib 50mg/50mg group was not in this analysis.||units on a scale * hours||Standard Error|Least Squares Mean
731502|NCT00403130|Secondary|Overall Survival (OS), All Participants|Overall Survival (OS), based on date of death or last known date alive|6 years|||months||Full Range|Median
731503|NCT00403130|Secondary|Overall Survival (OS), Confirmed|Overall Survival (OS) as determined by confirmed date of death|6 years|||months||Full Range|Median
731504|NCT00403130|Secondary|Response Rates|"The best overall response was recorded for each participant from randomization until disease progression/recurrence, using any increase from the smallest measurements recorded since randomization as the indicator of Progressive Disease (PD).
Overall response was determined on the basis of response at the target and non-target lesions, and the appearance of new lesions, as follows.
Target Nontarget New Lesions Overall Response
Complete Complete None Overall Complete Response
Complete Incomplete response/ None Overall Partial Response Stable Disease (SD)
Partial Not PD None Overall Partial Response
SD Not PD None Overall Stable Disease
PD Any Yes/No Overall PD
Any PD Yes/No Overall PD
Any Any Yes Overall PD
Overall Response Rate (ORR) was assessed as the sum of the Complete Response (CR) rate and the Partial Response (PR) rate."|24 weeks|Although 24 participants completed treatment, only 13 were evaluable for treatment effect.||Participants|||Count of Participants
731505|NCT00403130|Primary|Time-to-Progression (TTP)|Time-to-Progression (TTP) was assessed as the time from start of treatment to progression, as observed on radiographic scans.|2 years|Disease progression was documented for 9 participants.||months||Standard Deviation|Median
731506|NCT00403234|Primary|Number of Participants With Adverse Events (AEs) as a Measure of Safety|Adverse Events that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved.|From signed informed consent to 7 days after end of study (approx. 35 days)|The Safety Population consisted of subjects who were randomized, received at least 1 dose of double-blind study drug and had at least 1 safety assessment during double-blind treatment.||participants|||Number
731507|NCT00403273|Secondary|McGill Sensory Pain Score|McGill Sensory pain score on 0-33 at 2-month FU visit (higher score is worse)|2-month|patients providing data||units on a scale||Standard Deviation|Mean
731508|NCT00403273|Secondary|Correlation of Change in Joint Fluid Cytokine Levels With Improvement in Pain|Change in pain on WOMAC pain subscale score (range 0-100; higher number is worse); sensitivity analyses change in numeric rating scale (NRS) pain score (range 0-100; higher number is worse)|Baseline to 2-months||06/2017||||
731509|NCT00403273|Secondary|Correlation of Baseline Joint Fluid Cytokine Levels With Baseline Pain|Baseline pain on the WOMAC pain subscale score (range 0-100; higher number is worse)|Baseline values||06/2017||||
731510|NCT00403273|Secondary|McGill Affective Dimension|McGill Affective Dimension Score on 0-12 scale at 2-months (higher number is worse)|2-month|patients providing data||units on a scale||Standard Deviation|Mean
731511|NCT00403273|Secondary|Manual Muscle Strength Testing of Knee Flexion and Extension|Occurence of decrease in strength of knee flexion or extension at any of the follow-up visits, as measured by the Manual muscle strength testing (MMT) with scores ranging 0-5; 0 indicates None: No visible or palpable contraction; 1 indicates Trace: Visible or palpable contraction with no motion; 2 indicates Poor: Full range of motion (ROM) gravity eliminated; 3 indicates Fair: Full ROM against gravity; 4 indicates Good: Full ROM against gravity, moderate resistance; and 5 indicates Normal: Full ROM against gravity, maximal resistance|Upto 6-months|patients providing the data||participants|||Number
731606|NCT00405288|Post-Hoc|Cardiovascular Neonatal Health Concerns in the First Two Weeks After Birth|Assessment of neonate's morphology and function of cardiovascular system in the first two weeks after birth|neonatal period|||participants|||Number
731513|NCT00403273|Secondary|QOL: SF-36 Score Physical Functioning Scale, a Generic Health Status Measure|Short Form (SF)-36 physical functioning subscale on 0-100, at 2-month FU visit, as a generic health status measure, with a score ranging from 0 (worst physical functioning) to 100 (best physical functioning), with higher score indicating better physical functioning (higher number is better)|2-month|patients providing data||units on a scale||Standard Deviation|Mean
731514|NCT00403273|Secondary|Timed Up-and-go (TUG) Test|Time to get up from a chair, walk 3 meters turn back and sit in the chair in seconds at the 2-month visit (higher number is worse, i.e., taking a longer time to complete the task is worse)|2-month|patients providing data||seconds||Standard Deviation|Mean
731515|NCT00403273|Secondary|WOMAC Stiffness (0-100)|WOMAC stiffness subscale score on 0-100 scale at 2-month follow-up visit with scores ranging 0 (no joint stiffness) to 100 (worst joint stiffness), with higher score indicating worse joint stiffness|2-months|patients providing the data||units on a scale||Standard Deviation|Mean
731516|NCT00403273|Secondary|Physical Function Subscale of the WOMAC at 2-months|Physical Function subscale score of the WOMAC at 2-months on a 0 (best physical function) to 100 (worst physical function), with higher score indicating worse physical function|2-month|people providing data at 2-months||units on a scale||Standard Deviation|Mean
731517|NCT00403273|Secondary|Physician Global Assessment of Response to Treatment|Physician global assessed on an ordinal scale with very much improved category as the outcome of interest (compared to all other categories of global assessment as reference category)|2-month (primary end-point)|2 patients did not have the outcome assessment; 1 lost to FU||participants|||Number
731518|NCT00403273|Secondary|Mean Pain VAS (0-10)|VAS pain score at 2-month post-injection; Pain Severity on VAS ranges from 0 (no pain) to 10 (maximum pain) with higher score indicating worse pain|2-months post-injection|patients providing pain VAS data at 2-month FU visit||units on pain VAS scale||Standard Deviation|Mean
731519|NCT00403273|Primary|Participants With Clinically Meaningful Improvement in Pain Severity (0-10 cm; Higher Score on Pain Scale is Worse)|2-point reduction in pain Visual Analog Scale (VAS) from baseline to the 2-month follow-up visit, which is considered clinically meaningful Change in Pain Severity; Pain Severity on VAS ranges from 0 (no pain) to 10 (maximum pain)|2-month post-injection|all with follow-up data, allowing only single TKA per participant||participants|||Number
731520|NCT00403585|Secondary|Safety Assessment: Number of Participants With a Serious Adverse Event and an Adverse Event|The number of participants with a serious adverse event and an adverse event is reported. Refer to the adverse event section for details.|Treatment Phase (Weeks 53-156)|ITT Population||participants|||Number
731521|NCT00403585|Secondary|Number of Participants With HBeAg Loss, HBeAg Seroconversion, HBsAg Loss and HBsAg Seroconversion at Week 104 & 156|Hepatitis B e antigen (HBeAg) loss, HBeAg seroconversion (defined as HBeAg negative and hepatitis B e antibody [HBeAb] positive), hepatitis B surface antigen (HBsAg) loss and HBsAg seroconversion (defined as HBsAg negative and hepatitis B surface antibody [HBsAb] positive). HBeAg and HBsAg seroconversion are defined as the loss (becoming negative) of HBeAg and the concurrent appearance of antibodies against HBeAg and the loss of HBsAg and the concurrent appearance of antibodies against HBsAg, respectively.|Week 104 and 156|All participants achieving viological response, defined as an HBV DNA level ≤ 300. Some participants were not tested at various weeks.||Participants|||Number
731522|NCT00403585|Secondary|HBV DNA Levels at Each Collection Time Point From Baseline Through Week 156|Serum HBV DNA. Baseline is defined as the first day of study ADF103814, of which Study 108005 is an extension.|Baseline, Weeks 68, 80, 92, 104, 120, 132, 144, 156|Study ADF103814 ITT Population. As baseline is defined as the first day of study ADF103814, all 104 subjects enrolled in this study were analyzed. Some participants were not tested at various weeks.||log 10 copies/mL||Standard Deviation|Mean
731523|NCT00403585|Secondary|Number of Participants Achieving Virological Response at Week 104 & 156|Virological response is defined as HBV DNA level<300 copies/ml|Week 104, Week 156|ITT Population: some participants were not tested at Weeks 104 or 156.||Participants|||Number
731524|NCT00403585|Secondary|Number of Participants Achieving ALT Normalization at Week 104 & 156|Alanine aminotransferase (ALT) normalization is defined as a value <= upper limit of normal (ULN) range based on the set of subjects with ALT>ULN at baseline. The normal range for ALT is 0-40 Units/Liter.|Week 104, Week 156|ITT Population: some participants were not tested at Weeks 104 or 156.||Participants|||Number
731525|NCT00403585|Primary|Hepatitis B Virus (HBV) DNA (log10 Copies/mL) Change From Baseline at Week 156 of Adefovir Therapy|HBV DNA was tested with Roche Cobas Amplicor HBV monitor test, Lower Limit of Detection 300 copies/mL) after 3 years (156 weeks: Weeks 1-52 in Study ADF103814; Weeks 53-156 in Study 108005) of adefovir therapy). Change from baseline was calculated as the Week 156 value minus the Baseline value. Baseline is defined as the first day of study ADF103814, of which Study 108005 is an extension.|Baseline, Week 156|Study ADF103814 Intent-to-Treat (ITT) Population: All subjects regardless of whether or not the subject completed the planned duration of the study will be analyzed with no data exclusion. As baseline is defined as the first day of study ADF103814, all 104 subjects enrolled in this study were analyzed.||log10 copies/mL||Standard Deviation|Mean
731526|NCT00403754|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 5 Minutes Post-dose on Day 1 to 24 Hours Post-dose on Day 2|Spirometry was conducted according to internationally accepted standards. Standardized area under the curve (AUC0-24h) of FEV1 values taken at pre-dose to 24 hours post dose was calculated based on the trapezoidal rule. Analysis of Covariance was carried out with a mixed model that used (period) baseline, defined as the value of FEV1 measured prior to the first study drug intake in the period, as a covariate.|5 minutes to 12 hours post-dose on Day 1; and 22 to 24 hours post-dose on Day 2|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.||Liters||Standard Error|Least Squares Mean
731527|NCT00403754|Secondary|Peak Forced Expiratory Volume in 1 Second (FEV1) From 5 Minutes to 4 Hours Post-dose on Day 1|Spirometry was conducted according to internationally accepted standards. Peak FEV1 is the maximum FEV1 recorded in the period between 5 minutes and 4 hours post dose. Analysis of Covariance was carried out with a mixed model that used (period) baseline, defined as the value of FEV1 measured prior to the first study drug intake in the period, as a covariate.|5 minutes to 4 hours post-dose on Day 1|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.||Liters||Standard Error|Least Squares Mean
731528|NCT00403754|Secondary|Forced Expiratory Volume in 1 Second (FEV1) by Time Point From 5 Minutes to 12 Hours Post-dose on Day 1 and From 22 to 24 Hours Post-dose on Day 2|Spirometry was conducted according to internationally accepted standards. FEV1 by time point was calculated using a mixed model with (period) baseline, defined as the value measured prior to the first study drug intake in the period, as a covariate.|5, 15, and 30 minutes; and 1, 2, 4, 8, and 12 hours post-dose on Day 1; and 22, 23, and 24 hours post-dose on Day 2|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.||Liters||90% Confidence Interval|Least Squares Mean
731529|NCT00403754|Primary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 22 to 24 Hours Post-dose on Day 2|Spirometry was conducted according to internationally accepted standards. Standardized area under the curve (AUC22-24h) of FEV1 values taken at 22, 23 and 24 hours post dose, was calculated based on the trapezoidal rule. Analysis of Covariance was carried out with a mixed model that used (period) baseline, defined as the value of FEV1 measured prior to the first study drug intake in the period, as a covariate.|22, 23, and 24 hours post-dose on Day 2|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.||Liters||Standard Error|Least Squares Mean
731530|NCT00403767|Secondary|All-cause Mortality|The number of patients who died due to any cause while on treatment. The statistical analysis is based on time from randomization to the event while on treatment.|Up to 4 years|The safety population consisted of all randomized unique patients who took at least 1 dose of study medication after randomization during the double-blind treatment period. Site 042012 with GCP violation was excluded.||Patients|||Number
731531|NCT00403767|Secondary|The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Vascular Death|The number of patients with the occurrence of vascular death while on treatment. The statistical analysis is based on time from randomization to the event while on treatment.|Up to 4 years|The safety population consisted of all randomized unique patients who took at least 1 dose of study medication after randomization during the double-blind treatment period. Site 042012 with GCP violation was excluded.||Patients|||Number
731532|NCT00403767|Secondary|The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Myocardial Infarction|The number of patients with the first occurrence of a myocardial infarction while on treatment. The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment.|Up to 4 years|The safety population consisted of all randomized unique patients who took at least 1 dose of study medication after randomization during the double-blind treatment period. Site 042012 with GCP violation was excluded.||Patients|||Number
731533|NCT00403767|Secondary|The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Non-CNS Systemic Embolism|The number of patients with the first occurrence of a non-CNS systemic embolism while on treatment. The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment.|Up to 4 years|The safety population consisted of all randomized unique patients who took at least 1 dose of study medication after randomization during the double-blind treatment period. Site 042012 with GCP violation was excluded.||Patients|||Number
731534|NCT00403767|Secondary|The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Stroke|The number of patients with the first occurrence of a stroke while on treatment. The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment.|Up to 4 years|The safety population consisted of all randomized unique patients who took at least 1 dose of study medication after randomization during the double-blind treatment period. Site 042012 with GCP violation was excluded.||Patients|||Number
731535|NCT00403767|Secondary|The Composite Event of Stroke/Non-CNS Systemic Embolism/Myocardial Infarction/Vascular Death|The number of patients with the first occurrence of a stroke, non-CNS systemic embolism, myocardial infarction, or vascular death while on treatment. The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment.|Up to 4 years|The safety population consisted of all randomized unique patients who took at least 1 dose of study medication after randomization during the double-blind treatment period. Site 042012 with GCP violation was excluded.||Patients|||Number
731536|NCT00403767|Secondary|The Composite Event of Stroke/Non-CNS Systemic Embolism/Vascular Death|The number of patients with the first occurrence of a stroke, non-CNS systemic embolism, or vascular death while on treatment. The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment.|Up to 4 years|The safety population consisted of all randomized unique patients who took at least 1 dose of study medication after randomization during the double-blind treatment period. Site 042012 with GCP violation was excluded.||Patients|||Number
731537|NCT00403767|Primary|The Composite Event of Major/Non-major Clinically Relevant Bleeding Events: Primary Safety|The number of patients with the first occurrence of a major or non-major clinically relevant bleeding event while on treatment. The statistical analysis is based on time from the first dose of study drug to the first occurrence of the event while on treatment.|Up to 4 years|The safety population consisted of all randomized unique patients who took at least 1 dose of study medication after randomization during the double-blind treatment period.||Patients|||Number
731538|NCT00403767|Primary|The Composite of Event of Stroke/Non-CNS Systemic Embolism: Primary Efficacy (Superiority)|The number of patients with the first occurrence of a stroke or non-CNS systemic embolism while on treatment (defined as the time interval from the first dose to the last dose of study drug plus 2 days). The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment.|Up to 4 years|The safety population consisted of all randomized unique patients who took at least 1 dose of study medication after randomization during the double-blind treatment period. Site 042012 with GCP violation was excluded.||Patients|||Number
731539|NCT00403767|Primary|The Composite Event of Stroke/Non-CNS Systemic Embolism: Primary Efficacy (Non-Inferiority)|The number of patients with the first occurrence of a stroke or non-CNS systemic embolism while on treatment (defined as the time interval from the first dose to the last dose of study drug plus 2 days). The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment.|Up to 4 years|The per-protocol (PP) population consisted of all randomized unique patients excluding those who had specific pre-defined major protocol deviations that occurred by the time of enrollment into the study or during the trial. Site 042012 with GCP violation was excluded.||Patients|||Number
731540|NCT00403845|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 5 Minutes to 12 Hours Post-dose on Day 1 and From 22 to 24 Hours Post-dose on Day 2|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made in each treatment period at 5, 15, and 30 minutes and 1, 2, 4, 8, and 12 hours on Day 1 and 22, 23, and 24 hours on Day 2. Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included baseline FEV1 prior to drug administration in the treatment period as a covariate.|From 5 minutes to 12 hours post-dose on Day 1 and from 22 to 24 hours post-dose on Day 2|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were included in the analysis if they had at least 1 FEV1 value at 22, 23, or 24 hours post-dose, and the data were not collected within 6 hours after the use of rescue medication.||Liters||Standard Error|Least Squares Mean
731541|NCT00403845|Secondary|Forced Expiratory Volume in 1 Second (FEV1) by Time Point From 5 Minutes to 12 Hours Post-dose on Day 1 and From 22 to 24 Hours Post-dose on Day 2|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made in each treatment period at 5, 15, and 30 minutes and 1, 2, 4, 8, and 12 hours on Day 1 and 22, 23, and 24 hours on Day 2. The analysis included baseline FEV1 prior to drug administration in the treatment period as a covariate.|From 5 minutes to 12 hours post-dose on Day 1 and from 22 to 24 hours post-dose on Day 2|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.||Liters||90% Confidence Interval|Least Squares Mean
731542|NCT00403845|Secondary|Peak Forced Expiratory Volume in 1 Second (FEV1) From 5 Minutes to 4 Hours Post-dose on Day 1|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made in each treatment period at 5, 15, and 30 minutes and 1, 2, and 4 hours post-dose on Day 1. The analysis included baseline FEV1 prior to drug administration in the treatment period as a covariate.|From 5 minutes to 4 hours post-dose on Day 1|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.||Liters||Standard Error|Least Squares Mean
731543|NCT00403845|Primary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 22 to 24 Hours Post-dose on Day 2|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made in each treatment period at 22, 23, and 24 hours post-dose on Day 2. Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included patient, period, and treatment group as fixed effects and baseline FEV1 prior to drug administration in the treatment period as a covariate.|From 22 to 24 hours post-dose on Day 2|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were included in the analysis if they had at least 1 FEV1 value at 22, 23, or 24 hours post-dose, and the data were not collected within 6 hours after the use of rescue medication.||Liters||Standard Error|Least Squares Mean
731544|NCT00404079|Secondary|EuroQol-5D||1 year||||||
731545|NCT00404079|Secondary|Visual Analogue Scale||1 year||||||
731546|NCT00404079|Primary|Roland Morris Disability Questionnaire|The primary outcome was scores on the Norwegian version of Roland Morris Disability Questionnaire (RMDQ). RMDQ is a widely used back-specific, self-administered measure of pain-related disability. Greater levels of disability give higher numbers on a 24-point scale. RMDQ has content and construct validity and internal consistency. It is also reproducible and sensitive to change over time for LBP patients. A 3-point reduction in the total RMDQ was a priori classified as a response to treatment.|1 year|The number of participants for analysis followed the intention to treat principle. Imputation was performed with mulitple imputation.||units on a scale (0-24)||Standard Deviation|Mean
731547|NCT00404092|Primary|Safety and Tolerability of Caspofungin in Four Escalating Dosages in Adult Patients With Hematologic Malignancies and Proven or Probable Invasive Aspergillosis|Endpoints of safety and tolerability are the number of toxicity-related study therapy discontinuations and grade III and IV clinical and laboratory events, as evaluated on the basis of current NCI criteria.|End of caspofungin treatment, treatment duration varied between 3 and 29 days (mean: 20.5; median: 24.5)|||events|||Number
731548|NCT00404092|Secondary|Efficacy of Caspofungin in Four Escalating Dosages in the Treatment of Proven or Probable Invasive Aspergillosis.|"Numbers of patients in each dose cohort according to invasive aspergillosis (IA) outcome at end of protocol treatment (EOT), 4 weeks follow-up (4w FU) and 12 weeks follow-up (12w FU), respectively. 12w FU was only required for patients with a CR or PR at the 4w FU.
Definitions:
CR: resolution of all attributable symptoms, signs, and radiographic or bronchoscopic abnormalities.
PR: clinically meaningful improvement in attributable symptoms, signs, and radiographic (min. 50% decrease) or bronchoscopic abnormalities.
Stable disease (SD): no improvement in attributable symptoms, signs, and radiographic or bronchoscopic abnormalities.
Failure: deterioration in attributable clinical or radiographic abnormalities necessitating alternative antifungal therapy or resulting in death.
Relapse: reemergence of IA after EOT following CR, PR or SD or early withdrawal."|End of caspofungin treatment; 4 weeks follow-up; 12 weeks follow-up|All 46 recruited patients were included in the analysis. 2 (EOT), 16 (4w FU) and 23 (12w FU) outcomes out of 46 were not recorded.||participants|||Number
731549|NCT00404248|Secondary|Survival|Survival measured from first day of treatment to date of death|time to death - up to 12 months|3 pts still alive at time of analysis||months||Standard Deviation|Median
731550|NCT00404248|Secondary|Efficacy - Best Overall Response|Response Criteria: Complete Response (CR): complete disappearance of all tumor, off all steroids, stable or improving neuro exam for min of 4wks; Partial Response (PR): Greater than 50% reduction in tumor size, bi-dimensional MRI/CT, stable steroids, stable or improving neuro for min of 4 wks; Progressive Disease (PD): Progressive neurologic abnormalities not explanined by causes unrelated to tumor progression, or 25% increase in size of tumor by MRI/CT scan, or if new lesion appears; Stable Disease (SD): patient whose clinical status and MRI/CT measurements do not meet the criteria for CR, PR or PD.|About 2 years|3 pt did not have proper scans to be evaluable for analysis||participants|||Number
731551|NCT00404248|Secondary|Pharmacokinetics - Terminal Phase Half-life|effect of hepatic enzyme-inducing drugs on PKs|Cycle 1 Day 1- Predose: 1hour(hr) prior, 15minutes(min) prior; postdose: 1 hr15 min; 1.5hr, 2, 3,4, 6, 24 hrs. and Cycle 1 Day 5 Predose: 1hour(hr) prior, 15minutes(min) prior; postdose: 1 hr15 min; 1.5hr, 2, 3,4, 6, 24 hrs.|no PKs for Arm 3 (All EIASD) were collected. Due to incomplete collection of PKs on Cycle 1 Day 5 only the PKs from Cycle 1 Day 1 were used in the analysis||Hour||Standard Deviation|Mean
731552|NCT00404248|Secondary|Pharmacokinetics - Steady-State Apparent Volume Distribution|"effect of hepatic enzyme-inducing drugs on PKs
Cycle 1 Day 1 of treatment: Predose: 1hour(hr) prior, 15minutes(min) prior; postdose: 1 hr15 min; 1.5hr, 2, 3,4, 6, 24 hrs.
Cycle Day 5 of treatment: Predose: 1hour(hr) prior, 15minutes(min) prior; postdose: 1 hr15 min; 1.5hr, 2, 3,4, 6, 24 hrs."|Cycle 1 Day 1- Predose: 1hour(hr) prior, 15minutes(min) prior; postdose: 1 hr15 min; 1.5hr, 2, 3,4, 6, 24 hrs. and Cycle 1 Day 5 Predose: 1hour(hr) prior, 15minutes(min) prior; postdose: 1 hr15 min; 1.5hr, 2, 3,4, 6, 24 hrs.|no PKs were collected for Arm 3. Due to incomplete collection of PKs on Cycle 1 Day 5 only the PKs from Cycle 1 Day 1 were used in the analysis||Liters||Standard Deviation|Mean
731553|NCT00404248|Secondary|Pharmacokinetics - Total Body Clearance|"effect of hepatic enzyme-inducing drugs on PKs
Cycle 1 Day 1 of treatment: Predose: 1hour(hr) prior, 15minutes(min) prior; postdose: 1 hr15 min; 1.5hr, 2, 3,4, 6, 24 hrs.
Cycle Day 5 of treatment: Predose: 1hour(hr) prior, 15minutes(min) prior; postdose: 1 hr15 min; 1.5hr, 2, 3,4, 6, 24 hrs."|Cycle 1 Day 1- Predose: 1hour(hr) prior, 15minutes(min) prior; postdose: 1 hr15 min; 1.5hr, 2, 3,4, 6, 24 hrs. and Cycle 1 Day 5 Predose: 1hour(hr) prior, 15minutes(min) prior; postdose: 1 hr15 min; 1.5hr, 2, 3,4, 6, 24 hrs.|No PKs were collected for the three patients who were treated on Arm 3 (all EIASD). Due to incomplete collection of PKs on Cycle 1 Day 5 only the PKs from Cycle 1 Day 1 were used in the analysis||Liters/hour||Standard Deviation|Mean
731554|NCT00404248|Primary|Maximum Tolerated Dose (Phase I) - Dose Limiting Toxicity (DLT)|Dose limiting Toxicity defined as: Treatment related events; absolute neutrophil count </=500 /mm3; platelets count </=25,000/mm3; febrile neutropenia; any grade 3 or 4 non-hematologic toxicity; any delay in starting subsequent course of treatment for >14 days because of incomplete recovery from treatment|First 30 days|"+EIASD on hepatic enzyme-inducing drugs; -EIASE not on hepatic enzyme-induzing drug or drugs that significantly induce the hepatic enzyme.
IV Formulations: +PEG; 10mg/mL solution of PEG 300, hydroxypropyl-B-cyclodextrin & water ; -PEG; 6mg/mL, hydroxypropyl-B-cyclodextrin & water - NEW TC6 formulation"||Dose Limiting Toxicities (DLT)|||Number
731555|NCT00404248|Primary|Maximum Tolerated Dose (Phase I)|Using the PEG formulation pts both with and without enzyme inducing antiseizure drugs (EIASD) were treated at Doses 750, 1100, 1700, 2200 mg/day for five days = 28pts Using the PEG free formulation pts with and without EIASD) were treated at 1700 and 2200 mg/day X 5 days = 8pgs|first 30 days of treatment|||mg/day x 5 days|||Number
731556|NCT00404352|Secondary|Change From Baseline in Expanded Disability Status Score (EDSS) Score at Month 36|EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. The change in EDSS at Month 36 was calculated as EDSS at Month 36 minus EDSS at baseline.|Baseline, Month 36|"OL ITT population included all participants who were randomized at baseline in core REFLEX trial and entered the 12 months OLE period. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."||unit on a scale||Standard Deviation|Mean
731557|NCT00404352|Primary|Time to Conversion to Multiple Sclerosis (MS) According to the McDonald Criteria (2005)|The McDonald criteria use dissemination in time and space established by MRI findings to provide a clinical diagnosis for MS. Dissemination in time is established by a T2 or Gd+ lesion found on a repeat MRI. Dissemination in space is established by the presence of any 3 of the following: 1 Gd+ lesion or 9 T2 bright lesions if there is no enhancement; greater than or equal to 1 infratentorial lesion; greater than or equal to 1 juxtacortical lesion; greater than or equal to 3 periventricular lesions.|Various time points from randomization up to 36 months|Open label (OL) ITT population included all participants who were randomized at baseline in core REFLEX trial and entered the 12 months OLE period.||days||95% Confidence Interval|Median
731558|NCT00404352|Secondary|Change From Baseline in Time Constant 2 (T2) Lesion Volume , Time Constant 1 (T1) Hypointense Lesion Volume and Gadolinium Enhanced (Gd+) Lesion Volume at Month 36|Change from baseline in lesion volume was measured by using MRI scans for T2 lesions, T1 hypointense lesions and (Gd+) lesions.|Baseline, Month 36|"OL ITT population included all participants who were randomized at baseline in core REFLEX trial and entered the 12 months OLE period. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."||cubic millimeter (mm^3)||Standard Deviation|Mean
731559|NCT00404352|Secondary|Mean Number of Combined Unique Active (CUA) Lesions, New Time Constant 2 (T2) Lesions, Gadolinium Enhanced (Gd+) Lesions and New Time Constant 1 (T1) Hypointense Lesions Per Participant Per Scan|Number of CUA lesions, new T2 lesions, Gd+ lesions and new T1 hypointense lesions were measured by using MRI scans.|Month 24 up to Month 36|"OL ITT population included all participants who were randomized at baseline in core REFLEX trial and entered the 12 months OLE period. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."||lesions||Standard Deviation|Mean
731560|NCT00404352|Secondary|Time to Conversion to Clinically Definite Multiple Sclerosis (CDMS) Defined by Either a Second Attack or a 3-Month Sustained Increase (Greater Than or Equal to 1.5 Points) in the Expanded Disability Status Scale (EDSS) Score|CDMS was defined by the occurrence of a second exacerbation or relapse over 36 months in participants who presented with FCDE accompanied by an abnormal MRI scan. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated.|Various time points from randomization up to 36 months|OL ITT population included all participants who were randomized at baseline in core REFLEX trial and entered the 12 months OLE period.||days||95% Confidence Interval|Median
731561|NCT00404352|Secondary|Time to Conversion to Clinically Definite Multiple Sclerosis (CDMS) Defined by Either a Second Attack or a 3-Month Sustained Increase (Greater Than or Equal to 1.5 Points) in the Expanded Disability Status Scale (EDSS) Score|CDMS was defined by the occurrence of a second exacerbation or relapse over 24 months in participants who presented with first clinical demyelinating event (FCDE) accompanied by an abnormal MRI scan. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated.|Various time points from randomization up to 24 months|ITT population included all participants who were randomized to the assigned study treatment.||days||95% Confidence Interval|Median
731607|NCT00405288|Secondary|Neonatal Health|Neonatal health at birthyes=need for medical attention or intervention after birth, abnormalities detected, no= no need for medical attention, no abnormalities detected at birth|at birth|||participants|||Number
731608|NCT00405288|Secondary|Low Birth Weight at Birth|Low birth weight (birth weights <2500 grams)|at birth|Per protocol, the estimated number of 200 patients per arm, to detect significant difference of 200g in birth weight (primary outcome) for a power of 80% and alpha of 5% was used.||participants|||Number
731562|NCT00404352|Primary|Time to Conversion to Multiple Sclerosis (MS) According to the McDonald Criteria (2005)|The McDonald criteria use dissemination in time and space established by magnetic resonance image (MRI) findings to provide a clinical diagnosis for MS. Dissemination in time is established by a new time constant 2 (T2) or gadolinium-enhancing (Gd+) lesion found on a repeat MRI. Dissemination in space is established by the presence of any 3 of the following: 1 Gd+ lesion or 9 T2 bright lesions if there is no enhancement; greater than or equal to 1 infratentorial lesion; greater than or equal to 1 juxtacortical lesion; greater than or equal to 3 periventricular lesions.|Various time points from randomization up to 24 months|Intent-to-treat (ITT) population included all participants who were randomized to the assigned study treatment.||days||95% Confidence Interval|Median
731563|NCT00404495|Secondary|Overall Survival (OS)|Time in months from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 7 multiplied by 4.33. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death). Investigator's assessment.|Baseline to Date of Death (Up to 1 Year After Treatment)|All participants. One participant in the Temozolomide + Irinotecan for Medulloblastoma cohort did not have recurrent or refractory medulloblastoma and 3 participants in the Temozolomide + Irinotecan for High-Grade Glioma cohort did not have high-grade glioma, and were not considered evaluable for survival.||months||95% Confidence Interval|Median
731564|NCT00404495|Secondary|Time to Tumor Progression (TTP)|TTP was defined as the time in months from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever came first. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7 multiplied by 4.33. Tumor progression was determined from oncologic assessment data (where data met the criteria for PD). Investigator's assessment.|Baseline to Date of Progression (Up to 1 Year)|Evaluable local population||months||95% Confidence Interval|Median
731565|NCT00404495|Secondary|Time to Treatment Failure (TTF)|TTF was defined as the time from the date of first dose of study treatment to the date of the first documentation of progressive disease (PD), the date of treatment discontinuation except completion of treatment, or date of death due to cancer. Investigator's assessment.|Baseline to Date of Treatment Failure (Up to 1 Year)|Evaluable local population||months||95% Confidence Interval|Median
731566|NCT00404495|Secondary|Duration of Response|Median duration (50%) of tumor response for participants with objective disease response: who have not progressed or died due to any cause; with a response and subsequent progression or death due to any cause for duration of response (DR). DR was defined as time from start of first documented objective tumor response (CR or PR) to first documented objective tumor progression or death due to any cause, whichever occurred first. DR (calculated in Weeks) = (the end date for DR minus first subsequent confirmed CR or PR plus 1) divided by 7. Investigator's assessment.|Baseline to Date of Tumor Response (Up to 1 Year)|Evaluable local population. Number of participants analyzed=number of participants who responded.||weeks||Full Range|Median
731567|NCT00404495|Secondary|Percentage of Participants With Objective Response of Complete Response or Partial Response, Investigator's Assessment|Percentage of participants with objective response based assessment of confirmed CR or confirmed PR. CR persisted on repeat imaging study ≥4 weeks after initial documentation of response. PR, in case of bidimensionally measurable disease, was a decrease by ≥50% of the sum of the products of the largest perpendicular diameters of all measurable lesions as determined by 2 observations not less than 4 weeks apart. Best overall response could be recorded any time while the participant was receiving treatment. Investigator's assessment.|Baseline to 1 Year (medulloblastoma), Baseline to 6 Weeks (high-grade glioma)|Evaluable local population: Participants received at least 1 dose of study medication, had measurable disease under study, at least 1 on-study objective tumor assessment, completed at least 2 cycles of study treatment or progressed. Based on investigator's assessment.||percentage of participants||95% Confidence Interval|Number
731568|NCT00404495|Primary|Percentage of Participants With Objective Response of Complete Response or Partial Response|Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR). CR persisted on repeat imaging study at least (≥) 4 weeks after initial documentation of response. PR, for bidimensionally measurable disease, was a decrease by ≥50% of the sum of the products of the largest perpendicular diameters of all measurable lesions as determined by 2 observations not less than 4 weeks apart. Best overall response recorded any time while the participant was receiving treatment. External Response Review Committee (ERRC) assessment.|Baseline to 1 Year (medulloblastoma), Baseline to 6 Weeks (high-grade glioma)|Primary Evaluable Population: subset of evaluable population predetermined by 2-stage Optimum Simon design. Medulloblastoma cohort: n=consecutive evaluable participants up to 46 if 6 responses obtained in first 15 evaluable participants. Glioma cohort: n=consecutive evaluable participants up to 29 if 1 response in first 10 evaluable participants.||percentage of participants||95% Confidence Interval|Number
731573|NCT00404651|Secondary|Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine|Solicited Injection Site Reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Fever ([pyrexia] - temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability|Day 0 (pre-each vaccination) up to 7 days post-each dose|Solicited reactions were assessed in all subjects who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two batch 1 subjects got batch 2 vaccine, and 1 batch 1 got batch 3 vaccine. Total number (N) are those with available data for the outcome||Participants|||Number
731574|NCT00404651|Secondary|Geometric Mean Titers of Antibodies After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine|Antibody titers were measured for hepatitis B (Hep B) by enhanced chemiluminescence detection, for Haemophilus influenzae type b (PRP) by Farr type radioimmunoassay, for diphtheria (D) by toxin neutralization test, and for tetanus by enzyme linked immunosorbent assay. Antibody titers were measured for poliovirus types 1, 2, and 3 by neutralization assay. Antibody titers were measured for pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by enzyme linked immunosorbent assay (ELISA).|Day 150 (one month post-dose 3)|Geometric Mean Titers were assessed in all participants with endpoint data who did not have any protocol deviation that might have interfered with primary criteria evaluation (Per-Protocol Population).||Titers||95% Confidence Interval|Geometric Mean
731575|NCT00404651|Primary|Equivalence of Seroprotection Against Poliovirus Types 1, 2, and 3 in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine|Antibody titers were measured for poliovirus types 1, 2, and 3 by Enzyme immuno assay. Seroprotection against Poliovirus Types 1, 2, and 3 was defined as a titer ≥ 8 (1/dilutions).|Day 150 (one month post-dose 3)|Seroprotection was assessed in all participants who did not have any protocol deviation that might have interfered with primary criteria evaluation (Per-Protocol Population).||Participants|||Number
731576|NCT00404651|Primary|Equivalence of Seroprotection Against Pertussis in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine.|Antibody titers were measured for pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as a ≥ 4 fold increase in titer from Day 0 (before dose 1) to Day 150, one month post-dose 3.|Day 150 (one month post-dose 3)|Seroconversion was assessed in all participants who did not have any protocol deviation that might have interfered with primary criteria evaluation (Per-Protocol Population).||Participants|||Number
731577|NCT00404651|Primary|Equivalence of Seroprotection Against Vaccine Antigens in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine|Antibody titers were measured for hepatitis B (Hep B) by enhanced chemiluminescence detection, for Haemophilus influenzae type b (PRP) by Farr type radioimmunoassay, for Diphtheria (D) by toxin neutralization test, and for Tetanus (T) by enzyme-linked immunosorbent assay (ELISA). Seroprotection was defined as a titer ≥ 0.10 mIU/mL for Hep B, ≥ 0.15 µg/mL for PRP, and ≥ 0.01 IU/mL for D and T antibodies.|Day 150 (one month post-dose 3)|Seroprotection was assessed in participants that received a vaccine who did not have any protocol deviation that might have interfered with primary criteria evaluation (Per-Protocol Population). Total number (N) are those with available data for the endpoint.||Participants|||Number
731578|NCT00404820|Primary|Change of Cross-linked N-telopeptide of Type I Collagen (NTx) Level Assessed as Standardized Area Under the Curve From Screening to Month 12 in the Per Protocol Population|The level of bone activity as measured by NTx over the course of 12 months was assessed using the standardized area under the curve. Blood samples were collected after an overnight fast of at least 8 hours between 7:00 and 11:00 AM at Screening and Months 1.5, 3, 6, 9, and 12 months after baseline. Serum was analyzed at a central lab using commercially available ELISA kits. Standardized AUC was calculated by the AUC divided by the number of days the patient participated in the study.|Screening to end of study (Month 12)|Per Protocol population: All intent-to-treat patients who did not show major deviations from the protocol procedures that may have had an impact on the study outcome.||ng/ml||Standard Deviation|Mean
731579|NCT00404820|Secondary|Therapy Preference at End of Study (Month 12)|Patients were administered a questionnaire at the end of the study in which they were asked which type of therapy, weekly oral or yearly iv, they preferred.|Month 12|Intent-to-treat sample (ITT) population: All patients who received at least 1 dose of study medication and who had at least 1 post-baseline determination of cross-linked N-telopeptide of type I collagen (NTx) level.||Participants|||Number
731580|NCT00404820|Secondary|Change in Body Height From Baseline to Month 12|Body height was measured at Baseline and at the end of the study (Month 12) and the change in height calculated.|Baseline to end of study (Month 12)|Intent-to-treat sample (ITT) population: All patients who received at least 1 dose of study medication and who had at least 1 post-baseline determination of cross-linked N-telopeptide of type I collagen (NTx) level.||cm||Standard Deviation|Mean
731581|NCT00404820|Secondary|Number of Patients With a Clinical Fracture From Baseline to Month 12|A diagnosis of clinical fracture was based on physical examination findings, ie, swelling, tenderness, limited movement, pain.|Baseline to end of study (Month 12)|Intent-to-treat sample (ITT) population: All patients who received at least 1 dose of study medication and who had at least 1 post-baseline determination of cross-linked N-telopeptide of type I collagen (NTx) level.||Participants|||Number
731582|NCT00404820|Secondary|Change in the Qualeffo-41 Quality of Life (QoL) Questionnaire Score From Baseline to Month 12|The Qualeffo-41 QoL questionnaire was completed by the patient at Baseline and at Month 12. The questionnaire includes 41 questions covering 7 domains (pain, physical function and activities of daily living, physical function and jobs around the house, physical function and mobility, leisure and social activities, general health perception, mental function). Scores on each question range from 1 to 3, 4, or 5. The total score summed over all questions ranges from 41-205 points; the lower the score the higher the quality of life. A negative change score indicates improvement.|Baseline to end of study (Month 12)|Intent-to-treat sample (ITT) population: All patients who received at least 1 dose of study medication and who had at least 1 post-baseline determination of cross-linked N-telopeptide of type I collagen (NTx) level.||Units on a scale||Standard Deviation|Mean
731583|NCT00404820|Secondary|Change of Procollagen Type I Nitrogenous Propeptide (P1NP) Level Assessed as Standardized Area Under the Curve From Screening to Month 12|The level of bone activity as measured by P1NP over the course of 12 months was assessed using the standardized area under the curve. Blood samples were collected after an overnight fast of at least 8 hours between 7:00 and 11:00 AM at Screening and Months 1.5, 3, 6, 9, and 12 months after baseline. Serum was analyzed at a central lab using commercially available ELISA kits. Standardized AUC was calculated by the AUC divided by the number of days the patient participated in the study.|Screening to end of study (Month 12)|Intent-to-treat sample (ITT) population: All patients who received at least 1 dose of study medication and who had at least 1 post-baseline determination of cross-linked N-telopeptide of type I collagen (NTx) level.||ng/ml||Standard Deviation|Mean
731609|NCT00405288|Secondary|Fetal Distress|Presence of fetal distress at birth: heart deceleration/acceleration, meconium/amniotic fluid|at birth|||participants|||Number
731584|NCT00404820|Primary|Change of Cross-linked N-telopeptide of Type I Collagen (NTx) Level Assessed as Standardized Area Under the Curve From Screening to Month 12 in the Intent-to-Treat Population|The level of bone activity as measured by NTx over the course of 12 months was assessed using the standardized area under the curve. Blood samples were collected after an overnight fast of at least 8 hours between 7:00 and 11:00 AM at Screening and Months 1.5, 3, 6, 9, and 12 months after baseline. Serum was analyzed at a central lab using commercially available ELISA kits. Standardized AUC was calculated by the AUC divided by the number of days the patient participated in the study.|Screening to end of study (Month 12)|Intent-to-treat sample (ITT) population: All patients who received at least 1 dose of study medication and who had at least 1 post-baseline determination of cross-linked N-telopeptide of type I collagen (NTx) level.||ng/ml||Standard Deviation|Mean
731585|NCT00404924|Secondary|Time to Deterioration of Disease-related Symptoms (TDS) by Questionnaire - the Lung Cancer Subscale (LCS) a Selection of the FACT-L Focusing on Symptoms of Lung Cancer Plus Pain and Fatigue (LCS-PF)|Time to deterioration in symptoms is defined as the interval from the date of randomization to the first assessment of ‘worsened’ with no visit assessment of ‘improved’ within the next 28 days. Where assessment is by a selection of questions from the Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) questionnaire.|Disease-related symptom assessments are to be administered at screening (within 7 days before the first dose of study medication) and every 4 weeks thereafter, at discontinuation of study treatment and at the 30-day follow-up visit|||weeks||Inter-Quartile Range|Median
731586|NCT00404924|Primary|Overall Survival (OS)|Overall Survival (OS) is defined as the time from date of randomization until death. Any blinded/unknown patient which have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive (ie, their status must be known at the censored date and should not be lost to follow up or unknown).|Time to death in months|||Months||95% Confidence Interval|Median
731587|NCT00404924|Secondary|Duration of Response (DoR)|Response is defined as a confirmed best objective response of CR or PR. Duration of response is defined as time from the date of first documented response until date of documented progression or death in the absence of disease progression (provided death is within 3 months of last RECIST assessment)|RECIST tumour assessments carried out every 8 weeks from randomisation until objective disease progression|||Weeks||95% Confidence Interval|Median
731588|NCT00404924|Secondary|Disease Control Rate (DCR)|Disease control rate is defined as the number of patients who achieved disease control at 8 weeks following randomisation. Disease control at 8 weeks is defined as a best objective response of complete response (CR), partial response (PR) or stable disease (SD) >= 8 weeks|RECIST tumour assessments carried out every 8 weeks from randomisation until objective disease progression|||Participants|||Number
731589|NCT00404924|Secondary|Objective Response Rate (ORR)|"The ORR is the number of patients that are responders ie those patients with a confirmed best objective response of complete response (CR) or partial response (PR) as defined by RECIST criteria.
The categories for best objective response are CR, PR, stable disease (SD)>= 8 weeks, progressive disease (PD) or NE."|Each patient was assessed for objective response from the sequence of RECIST scan data up to data cut off. RECIST tumour assessments carried out every 8 weeks from randomisation until objective disease progression.|||Participants|||Number
731590|NCT00404924|Secondary|Progression-Free Survival (PFS)|Median time (in months) from randomisation until objective disease progression (determined by RECIST assessments) or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment|RECIST tumour assessments carried out every 8 weeks from randomisation until objective disease progression|||month||95% Confidence Interval|Median
731591|NCT00405067|Secondary|Percent Change in Body Weight at 12 Weeks as Compared to Baseline||Baseline and 12 weeks of treatment|||Percent Change||Standard Deviation|Mean
731592|NCT00405067|Secondary|Percent Change in High-sensitivity C-reactive Protein (Hs-CRP) at 12 Weeks as Compared to Baseline||Baseline and 12 weeks of treatment|||Percent Change||Standard Deviation|Mean
731593|NCT00405067|Secondary|Percent Change in Apolipoprotein B (Apo B) at 12 Weeks as Compared to Baseline||Baseline and 12 weeks of treatment|||Percent Change||Standard Deviation|Mean
731594|NCT00405067|Secondary|Percent Change in Apolipoprotein A1 (Apo A1) at 12 Weeks as Compared to Baseline||baseline and 12 weeks of treatment|||Percent Change||Standard Deviation|Mean
731595|NCT00405067|Secondary|Percent Change in Lipoprotein(a)[Lp(a)]at 12 Weeks as Compared to Baseline||Baseline and 12 weeks of treatment|||Percent Change||Standard Deviation|Mean
731596|NCT00405067|Secondary|Percent Change in HDL-C at 12 Weeks Compared to Baseline||Baseline and 12 weeks of treatment|||Percent Change||Standard Deviation|Mean
731597|NCT00405067|Secondary|Percent Change in Tryglycerides (TGs) at 12 Weeks Compared to Baseline||Baseline and 12 weeks of treatment|||Percent Change||Standard Deviation|Mean
731598|NCT00405067|Secondary|Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at 12 Weeks as Compared to Baseline.||Baseline and 12 weeks of treatment|||Percent Change||Standard Deviation|Mean
731599|NCT00405067|Secondary|Percent of Change at 12 Weeks Therapy Compared to Baseline Between Treatments for the Following Parameters: Total Cholesterol (TC)||Baseline and 12 weeks of treatment|||Percent Change||Standard Deviation|Mean
731600|NCT00405067|Primary|Percent Change in LDL-C at 12 Weeks Therapy Compared to Baseline Between Treatments||Baseline and 12 weeks of treatment|||Percent Change||Standard Deviation|Mean
731601|NCT00405275|Primary|Mean 48-week Change in DAS28|"Average difference between 48-week and Baseline DAS28.
The Disease Activity Score for 28 Joints (DAS28) is a well-validated composite outcome measure ranging from 2-10 (higher scores indicating more disease) that incorporates a tender and swollen joint count of 28 joints, a laboratory measure of systemic inflammation (ESR) and a patient-reported general assessment of health on a visual analog scale (ranging from 0-10cm) all into one measure.
Low disease activity is defined as DAS28 ≤ 3.2 units."|48 weeks after baseline assessment|Intention to treat analysis was performed on participants with Week 48 DAS28 data.||units on a scale||Standard Deviation|Mean
731602|NCT00405288|Post-Hoc|Other Neonatal Health Concerns||neonatal period|||participants|||Number
731603|NCT00405288|Post-Hoc|Skin Conditions in Neonatal Period||neonatal period|||participants|||Number
731604|NCT00405288|Post-Hoc|Neonatal Health Concerns-infections|Infections occuring in the neonatal period|neonatal period|||participants|||Number
731605|NCT00405288|Post-Hoc|Respiratory Neonatal Health Concerns||neonatal period|||participants|||Number
731614|NCT00405509|Secondary|Severity of Symptom Score - SNEEZING|Sneezing symptoms were rated by participants once a day for six days and on Day 30, symptoms were rated from 0 - 3 corresponding to none, mild, moderate and severe, respectively.|once a day for six days and on Day 30|||units on a scale||Standard Deviation|Mean
731615|NCT00405509|Secondary|Severity of Symptom Score - NASAL CONGESTION|nasal congestion symptoms were rated by the participant once a day for six days and on day 30. Symptoms were rated from 0 - 3 corresponding to none, mild, moderate and severe, respectively.|once a day for six days and on day 30|||units on a scale||Standard Deviation|Mean
731616|NCT00405509|Secondary|Severity of Symptom Scores - COUGH|Cough symptoms were rated by the participant each day for 6 days and on day 30. Symptoms were rated from 0 - 3 corresponding to none, mild, moderate and severe, respectively.|once a day for six days and on day 30|||units on a scale||Standard Deviation|Mean
731617|NCT00405509|Secondary|Nasal Secretion Weights|Nasal secretions were collected in pre-weighed tissues and then weighed upon return for nasal secretion weight|each day for 5 days|||grams||Standard Deviation|Mean
731618|NCT00405509|Primary|Local Leukotriene Levels|nasal secretions were collected once a day for the first six days of the respiratory infection and on day 30 then measured for leukotriene levels|once a day for 6 days and on day 30|||pg/ml||Standard Deviation|Mean
731619|NCT00405548|Secondary|Left Ventricular (LV) Filling Pressure|LV diastolic function as measured by Doppler echocardiography. E/e' is the ratio of the mitral inflow velocity (E) to the mitral annulus tissue Doppler velocity (e'). A decrease in the ratio indicates a lower filling pressure and improved LV diastolic function.|Baseline, 12 weeks|||E/e'||Standard Deviation|Mean
731620|NCT00405548|Primary|Change in Urinary Sodium Excretion in Response to Saline Load|Renal (or kidney) function was measured by the sodium or salt in the urine, following administration of a pre-specified amount of saline (salt).|Baseline, 12 weeks|||mEq/minute||Standard Deviation|Mean
731621|NCT00405548|Secondary|Change in Glomerular Filtration Rate (GFR) in Response to Saline Load|Renal or kidney function was measured by GFR determined by iothalamate clearance. GFR describes the flow rate of filtered fluid through the kidney measured in milliliters per minute per 1.73 m^2 of body surface area. A lower GFR means the kidney is not filtering normally. An estimated GFR of less than 60 mg/ml/1.73 m^2 of body surface area is considered to be impaired kidney function.|Baseline, 12 weeks|||ml/min/1.73 m^2 body surface area||Standard Deviation|Mean
731622|NCT00405548|Secondary|Change in Urinary Flow in Response to Saline Load|Urinary flow is a measure of renal (or kidney) function and was measured in milliliters per minute.|Baseline, 12 weeks|||ml/minute||Standard Deviation|Mean
731623|NCT00405587|Secondary|Tumor Levels of Phosphorylated Extracellular Signal-Regulated Kinapse (ERK), Cyclin D1, and Ki-67|The immunohisto-chemical analyses of the expression of phosphorylated ERK, cyclin D1, and Ki-67 in tumor-biopsy specimens was performed using hematoxylin and eosin staining.|BL and Day 15||||||
731624|NCT00405587|Secondary|Cmax of RO5185426 – Food Effect||Pre-morning dose, 0.5, 1, 2, 4, and 8 hour post-morning dose on Day 1 and 15, pre-morning dose on Day 2, Day 8, and Day 16||||||
731625|NCT00405587|Secondary|Decrease in Tumor Uptake of 18F-fluorodeoxyglucose (FDG)|Tumor uptake of FDG was assessed by means of positron-emission tomography (PET)|BL and Day 15||||||
731626|NCT00405587|Secondary|Mean Dose-Normalized Steady-State Cmax of RO5185426 80 mg and 120 mg Capsules - Dose Escalation: MBP Formulation and Extension: BRAFV600E- Positive Melanoma||Pre-morning dose, 0.5, 1, 2, 4, and 8 hour post-morning dose on Day 1 and 15, pre-morning dose on Day 2 and Day 8, and Day 16|PK Population: The analysis was planned only for those participants who received 80 or 120 mg dose of RO5185426 up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome.||ug/mL||Standard Deviation|Mean
731627|NCT00405587|Secondary|Mean Dose-Normalized Steady-State AUC of RO5185426 80 mg and 120 mg Capsules - Dose Escalation: MBP Formulation and Extension: BRAFV600E- Positive Melanoma|AUC (0-8 hour) was defined as the area under the plasma concentration-time curve from time equals 0 to 8 hours post-dose. AUC (0-24 hour) was defined as the area under the plasma concentration-time curve from time equals 0 to 24 hours post-dose. AUC (0-8 hour) and AUC (0-24 hour) were computed using the linear trapezoidal rule.|Pre-morning dose and at 0.5, 1, 2, 4, and 8, and 24 hours post-morning dose|The analysis was planned only for those participants who received 80 or 120 mg dose of RO5185426 up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome; n=participants evaluable for specified category.||ug*hr/mL||Standard Deviation|Mean
731628|NCT00405587|Secondary|Time to CR or PR Using RECIST v1.0 – Extension: BRAFV600E- Positive Melanoma|Time to CR or PR was defined as the interval between the date of the first treatment to the date of the first documentation of confirmed CR or PR whichever occurred first, and not the date of confirmation at the subsequent tumor assessment. Time to response = Date of first response – initial dose date + 1.|Screening, BL, and up to 168 days|Modified ITT population: Participants with a confirmed CR or PR with a measurable disease at BL and completed at least one post-baseline radiographic assessment or discontinued study medication early due to disease progression were considered.||days||Full Range|Median
731629|NCT00405587|Secondary|Overall Survival (OS) – Extension: BRAFV600E- Positive Melanoma|OS was the period of time measured from the date of initiation of therapy to the date of the death. In the event of no death prior to study termination or analysis data cutoff, OS was censored at the last known date that the patient was alive as documented on the follow-up case report form. If this date was not available, then the last known alive date from the database was used.|Screening, BL, until PD, or end of efficacy follow-up, up to 444 days|Modified ITT Population: All participants with a measurable disease at BL and completed at least one post-baseline radiographic assessment or discontinued study medication early due to disease progression were considered. Twenty participants were censored for analysis.||days||95% Confidence Interval|Median
731630|NCT00405587|Secondary|Percentage of Participants Who Died – Extension: BRAFV600E- Positive Melanoma||Screening, BL, until PD, or end of efficacy follow-up, up to 444 days|Modified ITT Population: All participants with a measurable disease at BL and completed at least one post-baseline radiographic assessment or discontinued study medication early due to disease progression were considered.||percentage of participants|||Number
733753|NCT00422383|Secondary|Change From BL in Activated Complement Component 3a (C3a) Protein Level in g/L||BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint||g/L||Standard Deviation|Mean
731631|NCT00405587|Secondary|PFS Using RECIST v1.0 – Extension BRAFV600E Positive Melanoma|PFS was the period of time measured from the date of initiation of therapy to the date of the appearance of new metastatic lesions, objective tumor progression, or death if before progression. PD was at least a 20% increase in the sum of longest diameters of TLs taking as reference the smallest sum of longest diameters recorded since the baseline measurements, or the appearance of one or more new lesion(s). For Non-TLs, disease progression was defined as the appearance of one or more new lesions and/or unequivocal progression of existing non-TLs. In the event of no disease progression or documented death prior to study termination, analysis cutoff, or start of confounding anticancer therapy, PFS was censored at the date of the last evaluable tumor assessment.|Screening, BL, until PD, or end of efficacy follow-up, up to data cutoff (up to 421 days)|Modified ITT population: All participants with a measurable disease at BL and completed at least one post-baseline radiographic assessment or discontinued study medication early due to disease progression were considered. Eight participants were censored for analysis.||days||95% Confidence Interval|Median
731632|NCT00405587|Secondary|Percentage of Participants With Progression-Free Survival (PFS) Using RECIST v 1.0 - Melanoma Extension Cohort|PFS was the period of time measured from the date of initiation of therapy to the date of the appearance of new metastatic lesions, objective tumor progression, or death if before progression. PD was defined according to the RECIST criteria (v 1.0) as increase by at least 20% in the sum of the longest diameters of each TL, taking as a reference the smallest sum of the longest diameters, reported since the start of treatment, or appearance of one or more new lesions. For Non-TLs, PD was defined as the appearance of one or more new lesions and/or unequivocal progression of existing non-TLs.|Month 1, 3, 4, 6, 9, and Last event (350) days|Modified ITT population: All participants with a measurable disease at BL and completed at least one post-baseline radiographic assessment or discontinued study medication early due to disease progression were considered. Eight participants were censored for analysis.||percentage of participants|||Number
731633|NCT00405587|Secondary|Duration of CR or PR Using RECIST v 1.0 – Extension BRAFV600E- Positive Melanoma|Duration of response for participants with confirmed CR or PR was the period of time measured between the date that the criteria for objective CR or PR (whichever status was recorded first) was met, and the first date that recurrent or PD was objectively documented (or death if before progression). PD was at least a 20% increase in the sum of longest diameters of TLs taking as reference the smallest sum of longest diameters recorded since the baseline measurements, or the appearance of one or more new lesion(s). In the event of no disease progression or documented death prior to study termination, analysis cutoff, or initiation of confounding anticancer therapy, duration of response was censored at the date of the last evaluable tumor assessment.|Screening, BL, until PD, or end of efficacy follow-up, up to data cutoff (up to 337 days)|Modified ITT population: Participants with confirmed CR or PR with a measurable disease at BL, and completed at least one post-baseline radiographic assessment or discontinued study medication early due to disease progression were considered. Seven participants were censored for analysis.||days||95% Confidence Interval|Median
731634|NCT00405587|Primary|Percentage of Participants With BOR of CR or PR According to RECIST v1.0 – Dose Escalation: MBP Formulation|BOR of CR or PR was recorded from baseline until disease progression/recurrence according to RECIST v 1.0 criteria. For TLs, CR was defined as the disappearance of all TLs, and PR was defined as at least a 30% decrease in the sum of longest diameters of the TLs, taking as a reference the BL sum of longest diameters. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. Percentage of participants with best overall response rate was calculated as the (number of participants with CR or PR) divided by (total number of participants in the cohort), and then multiplied by 100. The 95% Cl was determined using the Pearson-Clopper method.|Screening, BL, until PD, or end of efficacy follow-up, up to data cutoff (up to 337 days)|Modified ITT population: All participants with a measurable disease at BL and completed at least one post-baseline radiographic assessment or discontinued study medication early due to disease progression were considered evaluable for efficacy.||percentage of participants||95% Confidence Interval|Number
731635|NCT00405587|Primary|Percentage of Participants With BOR of CR or PR According to RECIST v1.0 – Dose Escalation: Original Formulation|BOR of CR or PR was recorded from baseline until disease progression/recurrence according to RECIST v 1.0 criteria. For TLs, CR was defined as the disappearance of all TLs, and PR was defined as at least a 30% decrease in the sum of longest diameters of the TLs, taking as a reference the BL sum of longest diameters. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. Percentage of participants with best overall response rate was calculated as the (number of participants with CR or PR) divided by (total number of participants in the cohort), and then multiplied by 100. The 95% Cl was determined using the Pearson-Clopper method.|Screening, BL, until PD, or end of efficacy follow-up, up to data cutoff (up to 337 days)|Modified ITT population: All participants with a measurable disease at BL and completed at least one post-baseline radiographic assessment or discontinued study medication early due to disease progression were considered evaluable for efficacy.||percentage of participants||95% Confidence Interval|Number
731636|NCT00405587|Primary|Percentage of Participants With BOR of CR or PR According to RECIST v1.0 – Extension: BRAFV600E- Positive CRC|BOR of CR or PR was recorded from baseline until disease progression/recurrence according to RECIST v 1.0 criteria. For TLs, CR was defined as the disappearance of all TLs, and PR was defined as at least a 30% decrease in the sum of longest diameters of the TLs, taking as a reference the BL sum of longest diameters. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. Confirmed responses were those which were confirmed by repeat assessments performed no less than four weeks after the criteria for response are first met Percentage of participants with best overall response rate was calculated as the (number of participants with CR or PR) divided by (total number of participants in the cohort), and then multiplied by 100. The 95% Cl was determined using the Pearson-Clopper method.|Screening, BL, until PD, or end of efficacy follow-up, up to data cutoff (up to 337 days)|Modified ITT population: All participants with a measurable disease at BL and completed at least one post-baseline radiographic assessment or discontinued study medication early due to disease progression were considered evaluable for efficacy.||percentage of participants||95% Confidence Interval|Number
731694|NCT00405756|Secondary|Time to First Response|Data as of 11 May 2010 cutoff. Time to first response was defined as the time from start of treatment until first response as assessed by the Central Assessment Committee (CMC) based on European Group for Blood and Marrow Transplantation (EBMT) criteria.|Up to 66 weeks|Participants who had a partial response (PR) or complete response (CR)||weeks||Standard Deviation|Mean
731637|NCT00405587|Primary|Percentage of Participants With a Confirmed and an Unconfirmed Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) According to RECIST Version (v) 1.0 – Extension: BRAFV600E- Positive Melanoma|BOR of confirmed /unconfirmed (total) response was defined as CR or PR recorded from baseline until disease progression/recurrence according to Response Evaluation Criteria In Solid Tumors (RECIST) v 1.0 criteria. For target lesions (TLs), CR was defined as the disappearance of all TLs, and PR was defined as at least a 30 percent (%) decrease in the sum of longest diameters of the TLs, taking as a reference the baseline (BL) sum of longest diameters. For non-target lesions (NTLs), CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. Confirmed responses were those which were confirmed by repeat assessments performed no less than four weeks after the criteria for response are first met. Percentage of participants with best overall response rate was calculated as the (number of participants with CR or PR) divided by (total number of participants in the cohort), and then multiplied by 100. The 95% Cl was determined using the Pearson-Clopper method.|Screening, BL, until PD, or end of efficacy follow-up, up to data cutoff (up to 337 days)|Modified ITT population: All participants with a measurable disease at BL and completed at least one post-baseline radiographic assessment or discontinued study medication early due to disease progression were considered evaluable for efficacy.||percentage of participants||95% Confidence Interval|Number
731638|NCT00405587|Primary|Tmax of RO5185426 on Day 15 – Extension: BRAFV600E- Positive Melanoma and BRAFV600E- CRC||Pre-morning dose, 0.5, 1, 2, 4, and 8 hour post-morning dose on Day 15, and pre-morning dose on Day 16|Phamacokinetic (PK) Population: Participants who received all RO5185426 doses without dose reduction up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome.||hours||Full Range|Median
731639|NCT00405587|Primary|Tmax of RO5185426 on Day 1 – Extension: BRAFV600E- Positive Melanoma and BRAFV600E- CRC||Pre-morning dose, 0.5, 1, 2, 4, and 8 hour post-morning dose on Day 1, pre-morning dose on Day 2 and Day 8|Phamacokinetic (PK) Population: Participants who received all RO5185426 doses without dose reduction up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome.||hours||Full Range|Median
731640|NCT00405587|Primary|Cmax of RO5185426 on Day 15 – Extension: BRAFV600E- Positive Melanoma and BRAFV600E- Positive CRC||Pre-morning dose, 0.5, 1, 2, 4, and 8 hour post-morning dose on Day 15 and pre-morning dose on Day 16|Phamacokinetic (PK) Population: Participants who received all RO5185426 doses without dose reduction up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome.||microgram/milliliter||Standard Deviation|Mean
731641|NCT00405587|Primary|Cmax of RO5185426 on Day 1 – Extension: BRAFV600E- Positive Melanoma and BRAFV600E- Positive CRC||Pre-morning dose, 0.5, 1, 2, 4, and 8 hour post-morning dose on Day 1, pre-morning dose on Day 2 and Day 8|Phamacokinetic (PK) Population: Participants who received all RO5185426 doses without dose reduction up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome.||microgram/milliliter||Standard Deviation|Mean
731642|NCT00405587|Primary|AUC of RO5185426 on Day 15 – Extension: BRAFV600E- Positive Melanoma and BRAFV600E- Positive CRC|AUC (0-8 hour) was defined as the area under the plasma concentration-time curve from time equals 0 to 8 hours post-dose. AUC (0-24 hour) was defined as the area under the plasma concentration-time curve from time equals 0 to 24 hours post-dose. AUC (0-8 hour) and AUC (0-24 hour) were computed using the linear trapezoidal rule.|Pre-morning dose and at 0.5, 1, 2, 4, and 8, and 24 hours post-morning dose|Phamacokinetic (PK) Population: Participants who received all RO5185426 doses without dose reduction up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome; n=participants evaluable for specified category.||ug*hr/mL||Standard Deviation|Mean
731643|NCT00405587|Primary|AUC of RO5185426 on Day 1 – Extension: BRAFV600E- Positive Melanoma and BRAFV600E- Positive CRC|AUC (0-8 hour) was defined as the area under the plasma concentration-time curve from time equals zero (0) to 8 hours post-dose. AUC (0-24 hour) was defined as the area under the plasma concentration-time curve from time equals 0 to 24 hours post-dose. AUC (0-8 hour) and AUC (0-24 hour) were computed using the linear trapezoidal rule.|Pre-morning dose and at 0.5, 1, 2, 4, and 8, and 24 hours post-morning dose|Phamacokinetic (PK) Population: Participants who received all RO5185426 doses without dose reduction up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome; n=participants evaluable for specified category.||mcg*hr/mL||Standard Deviation|Mean
731644|NCT00405587|Primary|Tmax of RO5185426 on Day 15 – Dose Escalation: MBP Formulation||Pre-morning dose, 0.5, 1, 2, 4, and 8 hour post-morning dose on Day 15, and pre-morning dose on Day 16|Pharmacokinetic (PK) Population: Participants who received all RO5185426 doses without dose reduction up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome.||hours||Full Range|Median
731645|NCT00405587|Primary|Tmax of RO5185426 on Day 1 – Dose Escalation: MBP Formulation||Pre-morning dose, 0.5, 1, 2, 4, and 8 hour post-morning dose on Day 1, pre-morning dose on Day 2 and Day 8|Pharmacokinetic (PK) Population: Participants who received all RO5185426 doses without dose reduction up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome.||hours||Full Range|Median
731646|NCT00405587|Primary|Cmax of RO5185426 on Day 15 – Dose Escalation: MBP Formulation||Pre-morning dose, 0.5, 1, 2, 4, and 8 hour post-morning dose on Day 15, and pre-morning dose on Day 16|Pharmacokinetic (PK) Population: Participants who received all RO5185426 doses without dose reduction up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome; n=participants evaluable for specified category.||micrograms per milliliter||Standard Deviation|Mean
731742|NCT00399308|Secondary|Secondary Efficacy: Proportion of Patients Achieving 90% Re-epithelialization After 12 Weeks of Active Treatment.|Re-epithelialization was judged by the Medical Monitor based upon computerized planimetry of serial wound photographs.|12 Weeks|Intent-to-Treat population||participants|||Number
731647|NCT00405587|Primary|Cmax of RO5185426 on Day 1 – Dose Escalation: MBP Formulation||Pre-morning dose, 0.5, 1, 2, 4, and 8 hour post-morning dose on Day 1, pre-morning dose on Day 2 and Day 8|Pharmacokinetic (PK) Population: Participants who received all RO5185426 doses without dose reduction up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome; n=participants evaluable for specified category.||micrograms per milliliter||Standard Deviation|Mean
731648|NCT00405587|Primary|Mean RO5185426 Accumulation Ratios – Extension: BRAFV600E- Positive Melanoma and BRAFV600E- Positive CRC|Accumulation ratio is the ratio of AUC (0-8 hour) on Day 15 / AUC (0-8 hour) on Day 1.|Day 1 and Day 15: pre-morning dose and at 0.5, 1, 2, 4, and 8 hours post-morning dose|Pharmacokinetic (PK) Population: Participants who received all RO5185426 doses without dose reduction up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome; n=participants evaluable for specified category.||ratio||Standard Deviation|Mean
731649|NCT00405587|Primary|Mean RO5185426 Accumulation Ratios – Dose Escalation: MBP Formulation|Accumulation ratio is the ratio of AUC (0-8 hour) on Day 15 / AUC (0-8 hour) on Day 1.|Day 1 and Day 15: pre-morning dose and at 0.5, 1, 2, 4, and 8 hours post-morning dose|Pharmacokinetic (PK) Population: Participants who received all RO5185426 doses without dose reduction up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome; n=participants evaluable for specified category.||ratio||Standard Deviation|Mean
731650|NCT00405587|Primary|AUC of RO5185426 on Day 15 – Dose Escalation: MBP Formulation|AUC (0-8 hour) was defined as the area under the plasma concentration-time curve from time equals zero (0) to 8 hours post-dose. AUC (0-24 hour) was defined as the area under the plasma concentration-time curve from time equals 0 to 24 hours post-dose. AUC (0-8 hour) and AUC (0-24 hour) were computed using the linear trapezoidal rule.|Pre-morning dose and at 0.5, 1, 2, 4, and 8, and 24 hours post-morning dose|Pharmacokinetic (PK) Population: Participants who received all RO5185426 doses without dose reduction up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome; n=participants evaluable for specified category.||mcg*hr/mL||Standard Deviation|Mean
731651|NCT00405587|Primary|AUC of RO5185426 on Day 1 – Dose Escalation: MBP Formulation|AUC (0-8 hour) was defined as the area under the plasma concentration-time curve from time equals zero (0) to 8 hours post-dose. AUC (0-24 hour) was defined as the area under the plasma concentration-time curve from time equals 0 to 24 hours post-dose. AUC (0-8 hour) and AUC (0-24 hour) were computed using the linear trapezoidal rule.|Pre-morning dose and at 0.5, 1, 2, 4, and 8, and 24 hours post-morning dose|Pharmacokinetic (PK) Population: Participants who received all RO5185426 doses without dose reduction up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome; n=participants evaluable for specified category.||ug*hr/mL||Standard Deviation|Mean
731652|NCT00405587|Primary|Time to Peak Concentration (Tmax) of RO5185426 on Day 15 – Dose Escalation: Original Formulation||Pre-morning dose, 0.5, 1, 2, 4, and 8 hour post-morning dose on Day 15, pre-morning dose on Day 16|PK Population: Participants who received all RO5185426 doses without dose reduction up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome.||hours||Full Range|Median
731653|NCT00405587|Primary|Time to Peak Concentration (Tmax) of RO5185426 on Day 1 – Dose Escalation: Original Formulation||Pre-morning dose, 0.5, 1, 2, 4, and 8 hour post-morning dose on Day 1, pre-morning dose on Day 2 and Day 8|PK Population: Participants who received all RO5185426 doses without dose reduction up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome.||hours||Full Range|Median
731654|NCT00405587|Primary|Peak Concentration (Cmax) of RO5185426 on Day 15 – Dose Escalation: Original Formulation||Pre-morning dose and at 0.5, 1, 2, 4, and 8 hours post-morning dose on Day 15, pre-morning dose on Day 16|PK Population: Participants who received all RO5185426 doses without dose reduction up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome.||Micrograms per milliliter||Standard Deviation|Mean
731655|NCT00405587|Primary|Peak Concentration (Cmax) of RO5185426 on Day 1 – Dose Escalation: Original Formulation||Pre-morning dose and at 0.5, 1, 2, 4, and 8 hours post-morning dose on Day 1, pre-morning dose on Day 2 and Day 8|PK Population: Participants who received all RO5185426 doses without dose reduction up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome.||Micrograms per milliliter||Standard Deviation|Mean
731656|NCT00405587|Primary|Area Under the Plasma Concentration-Time Curve (AUC) of RO5185426 on Day 15 – Dose Escalation: Original Formulation|AUC (0-8 hour) was defined as the area under the plasma concentration-time curve from time equals 0 to 8 hours post-dose. AUC (0-24 hour) was defined as the area under the plasma concentration-time curve from time equals 0 to 24 hours post-dose. AUC (0-8 hour) and AUC (0-24 hour) were computed using the linear trapezoidal rule.|Pre-morning dose and at 0.5, 1, 2, 4, and 8, and 24 hours post-morning dose|PK Population: Participants who received all RO5185426 doses without dose reduction up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome; n=participants evaluable for specified category.||ug*hr/mL||Standard Deviation|Mean
731673|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Future Perspective Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale. For the future perspective scale, higher score = better perspective of the future.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population||units on a scale||Standard Deviation|Mean
731657|NCT00405587|Primary|Area Under the Plasma Concentration-Time Curve (AUC) of RO5185426 on Day 1 – Dose Escalation: Original Formulation|AUC (0-8 hour) was defined as the area under the plasma concentration-time curve from time equals zero (0) to 8 hours post-dose. AUC (0-24 hour) was defined as the area under the plasma concentration-time curve from time equals 0 to 24 hours post-dose. AUC (0-8 hour) and AUC (0-24 hour) were computed using the linear trapezoidal rule.|Pre-morning dose and at 0.5, 1, 2, 4, and 8, and 24 hours post-morning dose|Pharmacokinetic (PK) Population: Participants who received all RO5185426 doses without dose reduction up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome; n=participants evaluable for specified category.||ug*hr/mL||Standard Deviation|Mean
731658|NCT00405639|Primary|Change in Urinary Sodium Excretion in Response to Saline Load||baseline, 12 weeks|||mEq/min||Standard Deviation|Mean
731659|NCT00405639|Secondary|Change in Left Ventricular Mass Index|Left ventricular mass index (LVMI) is a surrogate of left ventricular hypertrophy and a predictor of cardiac morbidity and mortality in adults with hypertension. LVMI was measured with echocardiography, indexed to body surface area estimated by left ventricular (LV) cavity dimension and wall thickness at end-diastole.|baseline, 12 weeks|||g/m^2||Standard Deviation|Mean
731660|NCT00405639|Secondary|Change in Renal Function as Measured by Glomerular Filtration Rate (GFR) in Response to Saline Load|Kidney function was measured by GFR determined by iothalamate clearance. GFR describes the flow rate of filtered fluid through the kidney measured in milliliters per minute per 1.73 m^2 of body surface area. A lower GFR means the kidney is not filtering normally. An estimated GFR of less than 60 mg/min/1.73 m^2 of body surface area is considered to be impaired kidney function.|baseline, 12 weeks|||ml/min/1.73 m^2||Standard Deviation|Mean
731661|NCT00405639|Secondary|Change in Urine Flow in Response to Saline Load||baseline, 12 weeks|||ml/min||Standard Deviation|Mean
731662|NCT00405652|Secondary|The Number of Participants With Subclinical Rejection as Evaluated by a Change in Liver Enzymes|The number of participants with subclinical rejection episodes as defined by a steroid-sensitive, clinically relevant increase of AST, ALT, gamma-GT, AP or bilirubin (i.e., elevation of one or more of these enzymes that was considered clinically relevant and showed resolution upon treatment with a slight increase of steroid dosage).|12-20 weeks|Intent to Treat||Participants|||Number
731663|NCT00405652|Primary|Changes in Gastrointestinal Symptom Severity and Health Related Quality of Life|Change in Gastrointestinal symptom rating scale (GSRS) total score from baseline visit to follow-up visit 6-8 weeks after treatment. The GSRS has 5 subscales (reflux, diarrhea, constipation, abdominal pain, and indigestion) producing a mean subscale score ranging from 1 (no discomfort) to 7 (very severe discomfort). The GSRS total score was computed by the mean of the subscale scores.|Baseline, End of Study (6-8 weeks)|Intent to Treat Population (No last Observation Carried Forward). The number of participants completing the GSRS at Baseline = 31 and at the End of Study= 29.||Scores on a Scale||Standard Deviation|Mean
731664|NCT00405704|Secondary|Recurrent Febrile or Symptomatic UTI With Any Resistant Pathogen||2 years|The analysis population is restricted to the 38 subjects in the trimethoprim-sulfamethoxazole (TMP-SMZ) group and 69 subjects in the placebo group who had a recurrent UTI with an organism for which sensitivity to TMP-SMZ was assessed.||participants|||Number
731665|NCT00405704|Secondary|Recurrent Febrile or Symptomatic UTI With Resistant E. Coli||2 years|The analysis population is restricted to the 30 subjects in the trimethoprim-sulfamethoxazole (TMP-SMZ) group and 57 subjects in the placebo group who had a recurrent UTI with E. coli for which sensitivity to TMP-SMZ was assessed.||participants|||Number
731666|NCT00405704|Secondary|Presence of E.Coli Resistant to Trimethoprim-Sulfamethoxazole (TMP-SMZ) (Based on Rectal Swab)||2 years|The analysis population excluded 99 subjects in the trimethoprim-sulfamethoxazole group and 95 subjects in the placebo group who did not have stool analyzed at the outcome visit.||participants|||Number
731667|NCT00405704|Secondary|Treatment Failure Composite|Treatment failure was defined as the occurrence of two febrile urinary tract infections (UTIs), one febrile UTI and three symptomatic UTIs, four symptomatic UTIs, or new or worsening renal scarring on an interim scan (e.g,, the 12-month visit); renal scans from the 2-year visit are NOT considered in the treatment failure criteria.|2 years|||participants|||Number
731668|NCT00405704|Secondary|New Renal Scarring on Outcome Scan|New renal scarring was defined as scarring on the outcome renal scan with technetium -99m-labeled dimercaptosuccinic acid that was not present at baseline. Outcome DMSA scan performed at 2 years after enrollment or 3-4 months after the child had met treatment failure criteria.|2 years|The analysis population excluded 82 subjects in the trimethoprim-sulfamethoxazole group and 78 subjects in the placebo group who did not have an outcome dimercaptosuccinic acid scan.||participants|||Number
731669|NCT00405704|Secondary|Severe Renal Scarring on Outcome Scan|Severe renal scarring was defined as scarring in more than 4 of 12 segments in at least one kidney or global atrophy characterized by diffusely scarred and shrunken kidney. Outcome DMSA scan performed at 2 years after enrollment or 3-4 months after the child had met treatment failure criteria.|2 years|The analysis population excluded 75 subjects in the trimethoprim-sulfamethoxazole group and 70 subjects in the placebo group who did not have an outcome dimercaptosuccinic acid scan.||participants|||Number
731670|NCT00405704|Secondary|Outcome Renal Scarring|Renal scarring was defined as a decreased uptake of tracer that was associated with loss of contours or the presence of cortical thinning. Outcome dimercaptosuccinic acid (DMSA) scan was performed at 2 years after enrollment or 3-4 months after the child had met treatment failure criteria.|2 years|The analysis population excluded 75 subjects in the trimethoprim-sulfamethoxazole group and 70 subjects in the placebo group who did not have an outcome dimercaptosuccinic acid scan.||participants|||Number
731671|NCT00405704|Primary|Recurrent Febrile or Symptomatic Urinary Tract Infection During 2-year Follow-up||2 years|||participants|||Number
731672|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Body Image Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale. For the body image scale, higher scores = better body image.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population||units on a scale||Standard Deviation|Mean
731674|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Side Effects of Treatment Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale; higher score for the side effects scale = higher level of symptomatology.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population||units on a scale||Standard Deviation|Mean
731675|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale; higher score for the disease symptoms scale = higher level of symptomatology.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population||units on a scale||Standard Deviation|Mean
731676|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Financial Difficulties Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a problem scale like the financial problems scale = higher level of financial problems.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population||units on a scale||Standard Deviation|Mean
731677|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Diarrhoea Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the diarrhea scale = higher level of symptomatology/problems.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population||units on a scale||Standard Deviation|Mean
731678|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Constipation Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the constipation scale = higher level of symptomatology/problems.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population||units on a scale||Standard Deviation|Mean
731679|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Appetite Loss Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the appetite loss scale = higher level of symptomatology/problems.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population||units on a scale||Standard Deviation|Mean
731680|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Insomnia Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the insomnia scale = higher level of symptomatology/problems.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population||units on a scale||Standard Deviation|Mean
731681|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Dyspnoea Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the dyspnoea scale = higher level of symptomatology/problems.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population||units on a scale||Standard Deviation|Mean
731682|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Pain Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the pain scale = higher level of symptomatology/problems.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population||units on a scale||Standard Deviation|Mean
731683|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Nausea and Vomiting Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the nausea/vomiting scale = higher level of symptomatology/problems.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population||units on a scale||Standard Deviation|Mean
731762|NCT00399542|Secondary|Month 2 Constipation Severity Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|28 days|ITT with LOCF||units on a scale||Standard Deviation|Mean
731684|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the fatigue scale = higher level of symptomatology/problems.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population||units on a scale||Standard Deviation|Mean
731685|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Social Functioning Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better level of social functioning.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population||units on a scale||Standard Deviation|Mean
731686|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Congitive Functioning Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better level of cognitive functioning.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population||units on a scale||Standard Deviation|Mean
731687|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Emotional Functioning Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better level of emotional functioning.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population||units on a scale||Standard Deviation|Mean
731688|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Role Functioning Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score=better level of role functioning.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population||units on a scale||Standard Deviation|Mean
731689|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Physical Functioning Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score=better level of physical functioning.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population||units on a scale||Standard Deviation|Mean
731690|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Quality of Life Scale|Data as of 11 May 2010 cutoff. EORTC QLC-C30 is a 30-item questionnaire to assess the quality of life in cancer patients. EORTC QLQ-C30 includes functional scales (physical, role, cognitive, emotional, social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and other (dyspnoea, appetite loss, insomnia, constipation/diarrhea, financial difficulties). Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); two used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better quality of life.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population||units on a scale||Standard Deviation|Mean
731691|NCT00405756|Secondary|Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period|Data as of 11 May 2010 cutoff. Participant counts in different categories of TEAEs during the double-blind treatment period. A TEAE is as any AE occurring or worsening on or after the first treatment of any study drug, and within 30 days after the last dose of the last study drug. Severity grades according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE) on a 1-5 scale: Grade 1= Mild AE, Grade 2= Moderate AE, Grade 3= Severe AE, Grade 4= Life-threatening or disabling AE, Grade 5=Death related to AE. Dose reduction includes reduction with or without interruption.|Up to 169 weeks (Double-blind therapy period plus 4 weeks)|Safety population||participants|||Number
731692|NCT00405756|Secondary|Kaplan Meier Estimates for Time to Next Antimyeloma Therapy|Data as of 11 May 2010 cutoff. Time to the next antimyeloma therapy was defined as time from randomization to the start of another non-protocol antimyeloma therapy. Participants who do not receive another anti-myeloma therapy were censored at the last assessment or follow-up visit known to have received no new therapy.|Up to 168 weeks|Intent to treat population||weeks||95% Confidence Interval|Median
731693|NCT00405756|Secondary|Kaplan Meier Estimates for Duration of Response as Determined by the Central Adjudication Committee (CAC)|"Data as of 11 May 2010 cutoff. Duration of myeloma response was defined as the time from the initial response date to the earlier of progressive disease (PD) as determined by the CAC or death on study. PD was based on the European Group for Blood and Marrow Transplantation/International Bone Marrow Transplant Registry/Autologous Bone Marrow Transplant Registry [EBMT/IBMTR/ABMTR] criteria.
PD criteria includes increasing monoclonal paraprotein levels, bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia."|Up to 149 weeks|Population: Participants who achieved a partial response (PR) or complete response (CR).||weeks||95% Confidence Interval|Median
731763|NCT00399542|Secondary|Month 3 Bowel Straining Change From Baseline|0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|28 days|ITT with LOCF||units on a scale||Standard Deviation|Mean
731695|NCT00405756|Secondary|Number of Participants in Disease Response Categories Representing Their Best Response During the Double-blind Treatment Period|Data as of 11 May 2010 cutoff. Best response was determined by the Central Assessment Committee (CAC) based on the European Group for Blood and Marrow Transplantation (EBMT) criteria: Complete Response (CR)-absence of serum and urine monoclonal paraprotein for 6 weeks, plus no increase in size or number of bone lesions, plus other factors); Partial Response (PR)-not all CR criteria, plus >=50% reduction in serum monoclonal paraprotein plus others; Stable Disease (SD)- not PR or PD; Progressive Disease (PD)- reappearance of monoclonal paraprotein, bone lesions, other; Not Evaluable (NE).|Up to 165 weeks|Intent to treat population||participants|||Number
731696|NCT00405756|Secondary|Kaplan Meier Estimates of Time to Progression (TTP) Based on the Response Assessment by the Central Adjudication Committee (CAC)|"Data as of 11 May 2010 cutoff. TTP was the time between randomization and disease progression as determined by the CAC. PD was based on the European Group for Blood and Marrow Transplantation/International Bone Marrow Transplant Registry/Autologous Bone Marrow Transplant Registry [EBMT/IBMTR/ABMTR] criteria.
PD criteria includes increasing monoclonal paraprotein levels, bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia."|up to 165 weeks|Intent to treat population||weeks||95% Confidence Interval|Median
731697|NCT00405756|Secondary|Kaplan Meier Estimates of Overall Survival (OS)|Data as of 11 May 2010 cutoff. Overall survival (OS) was defined as the time between randomization and death. Participants who died, regardless of the cause of death, were considered to have had an event. Participants who were lost to follow-up prior to the end of the trial, or who were withdrawn from the trial, were censored at the time of last contact. Participants who were still being treated were censored at the last available date available, or clinical cut-off date, if it was earlier.|up to 177 weeks|Intent to treat population||weeks||95% Confidence Interval|Median
731698|NCT00405756|Secondary|Kaplan Meier Estimates of Progression-free Survival (PFS) From Start of Maintenance Therapy Period Based on the Response Assessment by the Central Adjudication Committee (CAC)|"Data as of 11 May 2010 cutoff. PFS calculated from the start of the Maintenance period to the earlier of the first documentation of progressive disease (PD) as determined by the CAC, or death on study due to any cause.
PD was based on the European Group for Blood and Marrow Transplantation/International Bone Marrow Transplant Registry/Autologous Bone Marrow Transplant Registry [EBMT/IBMTR/ABMTR] criteria.
PD criteria includes increasing monoclonal paraprotein levels, bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia."|Approximately week 37 (start of cycle 10) to week 165|Intent to treat (ITT) population of participants in Arms MPR+R and MPR+p who entered maintenance within the Double-blind Treatment Period||weeks||95% Confidence Interval|Median
731699|NCT00405756|Primary|Kaplan Meier Estimates of Progression-free Survival (PFS) Based on the Response Assessment by the Central Adjudication Committee (CAC)|"Data as of 11 May 2010 cutoff. PFS was calculated as the time from randomization to the earlier of the first documentation of progressive disease (PD) as determined by the CAC, or death on study due to any cause. PD was based on the European Group for Blood and Marrow Transplantation/International Bone Marrow Transplant Registry/Autologous Bone Marrow Transplant Registry [EBMT/IBMTR/ABMTR] criteria.
PD criteria includes increasing monoclonal paraprotein levels, bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia."|up to 165 weeks|Intent-to-treat population||weeks||95% Confidence Interval|Median
731700|NCT00405821|Secondary|Virologic and Immunologic Responses to ART in Those Who Progress to CD+4 Less Than 250cells/mL||6 months and 12 moths post ART initiation||||||
731701|NCT00405821|Secondary|Adherence to Acyclovir||2 years||||||
731702|NCT00405821|Secondary|Toxicity of Acyclovir||2 years||||||
731703|NCT00405821|Secondary|HIV-1 Viral Load Difference Between Arms|We measured mean annual rate of change in log10 viral load (copies/mL) for each group. We assessed difference in annual rate of change in log10 viral load (copies/mL) between groups.|baseline, 6 months, 12 months, 18 months, 24 months|We measured viral load at baseline and at 6 monthly follow-up visits during 24 months of follow-up for all subjects randomized on this study.||log10 (copies/mL)||95% Confidence Interval|Mean
731704|NCT00405821|Secondary|Difference in Number of Episodes of Genital Ulcer Disease Between Arms|We calculated incidence rate for each treatment arm for episodes of genital ulcer disease, and incidence rate ratio.|2 years|We conducted monthly clinical assessment for GUD on all randomized subjects during their entire follow-up period on this trial. The number of episodes of GUD is shown below.||episodes|||Number
731705|NCT00405821|Primary|Progression to AIDS (CD4+ Less Than 250 Cells/Microliter or World Health Org Stage IV dx, Excluding Esophageal Candidiasis)|Evaluate the effect of acyclovir prophylaxis vs placebo among HIV-1/HSV-2 co-infected individuals on the progression to AIDS (CD4+ less than 250 cells/microliter or World Health Org stage IV disease, excluding esophageal candidiasis)|2 years|Intention to treat analysis of all subjects randomized on the trial meeting the primary endpoint||participants|||Number
731706|NCT00405912|Primary|Biochemically Confirmed 7-day Point Prevalence Abstinence From Tobacco|"Point prevalence tobacco abstinence was adjudicated if the following conditions were met:(a) self-reported tobacco abstinence for the previous 7 days with a negative response to the question Have you used any type of tobacco,even a puff, in the past 7 days? and (b) Expired Carbon Monoxide equal or less then 8 parts per million."|12 weeks following start of medication|||participants|||Number
731707|NCT00405912|Secondary|Number of Subjects With Prolonged Abstinence From Tobacco|tobacco abstience during the 12-week course of SJW in two different oral doses of 300-mg three times a day or 600-mg three times a day compared to placebo at six months.|24 weeks after the start of medication|||participants|||Number
731708|NCT00405938|Secondary|Objective Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment|The Percentage of Patients Who Experience an Objective Benefit From Treatment|18 months||||||
731709|NCT00405938|Primary|Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease|Defined as the interval, in months, from the date of first treatment to the date of disease progression or death, whichever occurred first.|18 months|||months||95% Confidence Interval|Median
731764|NCT00399542|Secondary|Month 2 Bowel Straining Change From Baseline|0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|28 days|ITT with LOCF||units on a scale||Standard Deviation|Mean
731710|NCT00405964|Secondary|Change From Baseline in Participant's AM/PM PRIOR T5SS Over Days 1 to 85 of Treatment|AM/PM PRIOR (the participant’s status over previous 12 hours) T5SS from the participant's daily diary averaged over treatment Days 1 to 85. AM/PM is the average of separate AM and PM evaluations. Scores were defined for T5SS as 0: no symptoms to 15: all severe symptoms. A two-way analysis of variance (ANOVA) model with treatment and site effects was used to examine the treatment difference.|Baseline and Days 1-85|All randomized participants||units on a scale||Standard Error|Least Squares Mean
731711|NCT00405964|Secondary|Change From Baseline in the Total Rhinoconjunctivitis Quality of Life Questionnaire-Standarized Version (RQLQ-S) After 29 Days of Treatment|The RQLQ-S was only completed for participants above 18 years of age. The RQLQ-S was not available for participants 12 to 17 years of age. This questionnaire asked questions pertaining to daily activities, sleep, non-nose eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotions. The scale went from 0 (not troubled) to 6 (extremely troubled). A two-way analysis of variance (ANOVA) model with treatment and site effects was used to examine the treatment difference.|Baseline and Day 29|All randomized participants||units on a scale||Standard Error|Least Squares Mean
731712|NCT00405964|Primary|Change From Baseline in Participant's AM/PM PRIOR Total 5 Symptom Score (T5SS) Over Days 1 to 29 of Treatment|AM/PM PRIOR (the participant’s status over previous 12 hours) T5SS from the participant's daily diary averaged over treatment Days 1 to 29. AM/PM is the average of separate morning (AM) and evening (PM) evaluations. Scores were defined for T5SS as 0: no symptoms to 15: all severe symptoms. A two-way analysis of variance (ANOVA) model with treatment and site effects was used to examine the treatment difference.|Baseline and Days 1-29|All randomized participants||units on a scale||Standard Error|Least Squares Mean
731713|NCT00406029|Secondary|Change From Baseline in UPDRS Part 4|The UPDRS is a frequently used multi-item 4-part questionnaire designed to assess various aspects of Parkinson's disease severity. A total of 42 items are assessed divided across Parts 1 to 4. The Part 4 subscale assesses complications of therapy over the past week for a total of eleven question items. The first three questions and question 8 are rated from 0 (best) to 4 (worst), and the remaining seven questions are simple no (0) / yes (1) questions. The total subscale score ranges from 0 to 23. Assessments were obtained at baseline (predose Day 1) and 2 hours postdose at Weeks 2, 4, 6, 8, 10, and 12. For endpoint, the last postbaseline visit while on study medication was used. Change from baseline in LS means and pooled SD were obtained from an ANCOVA model with effect for treatment and baseline covariate. Negative change from baseline indicates a decrease in severity.|Baseline (predose Day 1) and 2 hours postdose at Weeks 2, 4, 6, 8, 10, 12|The Efficacy Population consisting of all treated participants who had post-baseline date (UPDRS Part 4) for the assessment week was used for analysis.||Units on a Scale||Standard Deviation|Least Squares Mean
731714|NCT00406029|Secondary|Change From Baseline in UPDRS Part 3 (2 Hours Post-dose)|The UPDRS is a frequently used multi-item 4-part questionnaire designed to assess various aspects of Parkinson's disease severity. A total of 42 items are assessed divided across Parts 1 to 4. The Part 3 subscale assesses motor function across 14 categories for 27 items. Scores for each item range from 0 (best) to 4 (worst) with a total range of 0-108. Assessments were obtained at baseline (predose Day 1) and 2 hours postdose at Weeks 2, 4, 6, 8, 10, and 12. For endpoint, the last postbaseline visit while on study medication was used. Change from baseline in LS means and pooled standard deviation were obtained from an ANCOVA model with effect for treatment and baseline covariate. Negative change from baseline indicates a decrease in severity.|Baseline (predose Day 1) and 2 hours postdose at Weeks 2, 4, 6, 8, 10, 12|The Efficacy Population consisting of all treated participants who had post-baseline data (UPDRS Part 3) for the assessment week was used for analysis.||Units on a Scale||Standard Deviation|Least Squares Mean
731715|NCT00406029|Secondary|Change From Baseline in UPDRS Part 3 (1 Hour Post-dose)|The UPDRS is a frequently used multi-item 4-part questionnaire designed to assess various aspects of Parkinson's disease severity. A total of 42 items are assessed divided across Parts 1 to 4. The Part 3 subscale assesses motor function across 14 categories for 27 items. Scores for each item range from 0 (best) to 4 (worst) with a total range of 0-108. Assessments were obtained at baseline (predose Day 1) and 1 hour postdose at Weeks 2, 4, 6, 8, 10, and 12. For endpoint, the last postbaseline visit while on study medication was used. Change from baseline in LS means and pooled SD were obtained from an ANCOVA model with effect for treatment and baseline covariate. Negative change from baseline indicates a decrease in severity.|Baseline (predose Day 1) and 1 hour postdose at Weeks 2, 4, 6, 8, 10, 12|The Efficacy Population consisting of all treated participants who had post-baseline data (UPDRS Part 3) for the assessment week was used for analysis.||Units on a Scale||Standard Deviation|Least Squares Mean
731716|NCT00406029|Secondary|Change From Baseline in UPDRS Part 2|The UPDRS is a frequently used multi-item 4-part questionnaire designed to assess various aspects of Parkinson's disease severity. A total of 42 items are assessed divided across Parts 1 to 4. Part 2 assesses daily living (13 items scored from 0 [best] to 4 [worst]; total range 0-52). Assessments were obtained at baseline (predose Day 1) and 2 hours postdose at Weeks 2, 4, 6, 8, 10, and 12. For endpoint, the last postbaseline visit while on study medication was used. Change from baseline in LS means and pooled SD were obtained from an ANCOVA model with effect for treatment and baseline covariate. Negative change from baseline indicates a decrease in severity.|Baseline (predose Day 1) and 2 hours postdose at Weeks 2, 4, 6, 8, 10, 12|The Efficacy Population consisting of all treated participants who had post-baseline data (UPDRS Part 2) for the assessment week was used for analysis.||Units on a Scale||Standard Deviation|Least Squares Mean
731717|NCT00406029|Secondary|Change From Baseline in Unified Parkinson’s Disease Rating Scale (UPDRS) Part 1|The UPDRS is a frequently used multi-item 4-part questionnaire designed to assess various aspects of Parkinson's disease severity. A total of 42 items are assessed divided across Parts 1 to 4. Part 1 assesses mentation (4 items scored from 0 [best] to 4 [worst]; total range 0-16). Assessments were obtained at baseline (predose Day 1) and 2 hours postdose at Weeks 2, 4, 6, 8, 10, and 12. For endpoint, the last postbaseline visit while on study medication was used. Change from baseline in LS means and pooled SD were obtained from an ANCOVA model with effect for treatment and baseline covariate. Negative change from baseline indicates a decrease in severity.|Baseline (predose Day 1) and 2 hours postdose at Weeks 2, 4, 6, 8, 10, 12|The Efficacy Population consisting of all treated participants who had post-baseline data (UPDRS Part 1) for the assessment week was used for analysis.||Units on a Scale||Standard Deviation|Least Squares Mean
731765|NCT00399542|Secondary|Month 3 Stool Consistency Change From Baseline|0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)|28 days|ITT with LOCF||units on a scale||Standard Deviation|Mean
731718|NCT00406029|Secondary|Change From Baseline in Frequency of Sleep Attacks at Week 12|Sleep attacks are uncontrollable episodes of sleep that occur during the daytime lasting a few seconds to several minutes. A questionnaire to determine sleep attacks over the prior 2 week period was administered at baseline and at 2-week intervals during the treatment period. Frequency of sleep attacks over the two-week treatment period intervals were tabulated in relation to the baseline assessment. Results are presented as participants showing the respective change in frequency of sleep attacks at baseline to the week of assessment (Week 12) (as reported by the participant). For example, someone who had >2 sleep attacks at BL who had a decrease of 1-2 by Week 12 would be reported as BL >2 to WK12 1-2. BL = baseline. WK = week.|Baseline (predose Day 1) and 2 hours postdose at Week 12|The Efficacy Population consisting of all treated participants who had post-baseline data (sleep attacks) for the assessment week was used for analysis.||Participants|||Number
731719|NCT00406029|Secondary|Change From Baseline in Frequency of Sleep Attacks at Week 10|Sleep attacks are uncontrollable episodes of sleep that occur during the daytime lasting a few seconds to several minutes. A questionnaire to determine sleep attacks over the prior 2 week period was administered at baseline and at 2-week intervals during the treatment period. Frequency of sleep attacks over the two-week treatment period intervals were tabulated in relation to the baseline assessment. Results are presented as participants showing the respective change in frequency of sleep attacks at baseline to the week of assessment (Week 10) (as reported by the participant). For example, someone who had >2 sleep attacks at BL who had a decrease of 1-2 by Week 10 would be reported as BL >2 to WK10 1-2. BL = baseline. WK = week.|Baseline (predose Day 1) and 2 hours postdose at Week 10|The Efficacy Population consisting of all treated participants who had post-baseline data (sleep attacks) for the assessment week was used for analysis.||Participants|||Number
731720|NCT00406029|Secondary|Change From Baseline in Frequency of Sleep Attacks at Week 8|Sleep attacks are uncontrollable episodes of sleep that occur during the daytime lasting a few seconds to several minutes. A questionnaire to determine sleep attacks over the prior 2 week period was administered at baseline and at 2-week intervals during the treatment period. Frequency of sleep attacks over the two-week treatment period intervals were tabulated in relation to the baseline assessment. Results are presented as participants showing the respective change in frequency of sleep attacks at baseline to the week of assessment (Week 8) (as reported by the participant). For example, someone who had >2 sleep attacks at BL who had a decrease of 1-2 by Week 8 would be reported as BL >2 to WK8 1-2. BL = baseline. WK = week.|Baseline (predose Day 1) and 2 hours postdose at Week 8|The Efficacy Population consisting of all treated participants who had post-baseline data (sleep attacks) for the assessment week was used for analysis.||Participants|||Number
731721|NCT00406029|Secondary|Change From Baseline in Frequency of Sleep Attacks at Week 6|Sleep attacks are uncontrollable episodes of sleep that occur during the daytime lasting a few seconds to several minutes. A questionnaire to determine sleep attacks over the prior 2 week period was administered at baseline and at 2-week intervals during the treatment period. Frequency of sleep attacks over the two-week treatment period intervals were tabulated in relation to the baseline assessment. Results are presented as participants showing the respective change in frequency of sleep attacks at baseline to the week of assessment (Week 6) (as reported by the participant). For example, someone who had >2 sleep attacks at BL who had a decrease of 1-2 by Week 6 would be reported as BL >2 to WK6 1-2. BL = baseline. WK = week.|Baseline (predose Day 1) and 2 hours postdose at Week 6|The Efficacy Population consisting of all treated participants who had post-baseline data (sleep attacks) for the assessment week was used for analysis.||Participants|||Number
731722|NCT00406029|Secondary|Change From Baseline in Frequency of Sleep Attacks at Week 4|Sleep attacks are uncontrollable episodes of sleep that occur during the daytime lasting a few seconds to several minutes. A questionnaire to determine sleep attacks over the prior 2 week period was administered at baseline and at 2-week intervals during the treatment period. Frequency of sleep attacks over the two-week treatment period intervals were tabulated in relation to the baseline assessment. Results are presented as participants showing the respective change in frequency of sleep attacks at baseline to the week of assessment (Week 4) (as reported by the participant). For example, someone who had >2 sleep attacks at BL who had a decrease of 1-2 by Week 4 would be reported as BL >2 to WK4 1-2. BL = baseline. WK = week.|Baseline (predose Day 1) and 2 hours postdose at Week 4|The Efficacy Population consisting of all treated participants who had post-baseline data (sleep attacks) for the assessment week was used for analysis.||Participants|||Number
731723|NCT00406029|Secondary|Change From Baseline in Frequency of Sleep Attacks at Week 2|Sleep attacks are uncontrollable episodes of sleep that occur during the daytime lasting a few seconds to several minutes. A questionnaire to determine sleep attacks over the prior 2 week period was administered at baseline and at 2-week intervals during the treatment period. Frequency of sleep attacks over the two-week treatment period intervals were tabulated in relation to the baseline assessment. Results are presented as participants showing the respective change in frequency of sleep attacks at baseline to the week of assessment (Week 2) (as reported by the participant). For example, someone who had >2 sleep attacks at BL who had a decrease of 1-2 by Week 2 would be reported as BL >2 to WK2 1-2. BL = baseline. WK = week.|Baseline (predose Day 1) and 2 hours postdose at Week 2|The Efficacy Population consisting of all treated participants who had post-baseline data (sleep attacks) for the assessment week was used for analysis.||Participants|||Number
731724|NCT00406029|Secondary|Change From Baseline in Total Sleep Time|Hours spent in the sleep state were recorded using a daily diary at least 3 full days before scheduled visit. For baseline, the 24-hour average over 3 consecutive days was derived for Week -1. For endpoint, the 24-hour average was derived for the last available 3 consecutive days with postbaseline data available during the treatment period. For treatment period visits, the 24-hour average was derived for the final 3 consecutive days with data available for the particular visit. Change from baseline in LS means & pooled SD were obtained using ANCOVA with treatment effect & baseline covariate. A positive change from baseline means more time asleep and a negative change means less time asleep.|Baseline (Week -1) and Weeks 2, 4, 6, 8, 10, 12|The Efficacy Population consisting of all treated participants who had post-baseline data (total sleep time) for the assessment week was used for analysis.||hours/day||Standard Deviation|Least Squares Mean
731741|NCT00399308|Secondary|Secondary Efficacy: Durability of Wound Closure Through 12 Weeks After the End of the Treatment Period.|The proportion of patients who had a recurrence of the study ulcer during follow-up after achieving wound closure during the active treatment period.|Variable - minimum of 12 weeks of follow-up.|Intent-to-treat population achieving primary outcome||participants|||Number
731725|NCT00406029|Secondary|Change From Baseline in Absolute Duration of Dyskinesias|Dyskinesias refers to maintenance therapy side effects of chorea, dystonia, or in combination (that occur in the ON time). Hours spent with dyskinesias (troublesome and not troublesome) were recorded in half-hour time intervals using a daily diary at least 3 full days before scheduled visits. For baseline, the 24-hour average over 3 consecutive days was derived for Week -1. For endpoint, the 24-hour average was derived for the last available 3 consecutive days with postbaseline data available during the treatment period. For treatment period visits, the 24-hour average was derived for the final 3 consecutive days with data available for the particular visit. Change from baseline in LS means & pooled SD were obtained using ANCOVA with treatment effect & baseline covariate. A negative change from baseline signifies less time spent with dyskinesia.|Baseline (Week -1) and Weeks 2, 4, 6, 8, 10, 12|"The Efficacy Population consisting of all treated participants who had post-baseline data (awake time per day in the on state with troublesome and not troblesome dyskinesias) for the assessment week was used for analysis."||hours/day||Standard Deviation|Least Squares Mean
731726|NCT00406029|Secondary|"Change From Baseline in Awake Time Per Day Spent in the on State (Without Troublesome Dyskinesias)"|"On time refers to periods of adequate control of Parkinson disease symptoms (better/absent). Troublesome dyskinesias refers to maint. therapy side effects of chorea, dystonia, or in combination that impair function. Hours spent in the on state without troubles. dyskinesias during awake time were recorded in half-hour time intervals using a daily diary at least 3 full days before scheduled visits. For baseline, the 24-hour average over 3 consecutive days was derived for Week -1. For endpoint, the 24-hour average was derived for the last available 3 consecutive days with postbaseline data available during the treatment period. For treatment period visits, the 24-hour average was derived for the final 3 consecutive days with data available for the particular visit. Change from baseline in LS means & pooled SD were obtained using ANCOVA with treatment effect & baseline covariate. A (+) change from baseline signifies more time spent in the on state (without troubles. dyskinesias)."|Baseline (Week -1) and Weeks 2, 4, 6, 8, 10, 12|"The Efficacy Population consisting of all treated participants who had post-baseline data (awake time per day in the on state without troublesome dyskinesias) for the assessment week was used for analysis."||hours/day||Standard Deviation|Least Squares Mean
731727|NCT00406029|Secondary|"Change From Baseline in Awake Time Per Day Spent in the on State (With Troublesome Dyskinesias)"|"On time refers to periods of adequate control of Parkinson disease symptoms (better/absent). Troublesome dyskinesias refers to maintenance therapy side effects of chorea, dystonia, or in combination that impair function. Hours spent in the on state with troublesome dyskinesias during awake time were recorded in half-hour time intervals using a daily diary at least 3 full days before scheduled visits. For baseline, the 24-hour average over 3 consecutive days was derived for Week -1. For endpoint, the 24-hour average was derived for the last available 3 consecutive days with postbaseline data available during the treatment period. For treatment period visits, the 24-hour average was derived for the final 3 consecutive days with data available for the particular visit. Change from baseline in LS means & pooled SD were obtained using ANCOVA with treatment effect & baseline covariate. A (+) change from baseline signifies more time spent in the on state (troublesome dyskinesias)."|Baseline (Week -1) and Weeks 2, 4, 6, 8, 10, 12|"The Efficacy Population consisting of all treated participants who had post-baseline data (awake time per day in the on state with troublesome dyskinesias) for the assessment week was used for analysis."||hours/day||Standard Deviation|Least Squares Mean
731728|NCT00406029|Secondary|"Change From Baseline in Awake Time Per Day Spent in the on State (no Dyskinesias)"|"On time refers to periods of adequate control of Parkinson disease symptoms (better/absent). Dyskinesias refers to maintenance therapy (e.g., L-dopa) side effects of chorea, dystonia, or in combination. Hours spent in the on state with no dyskinesias during awake time were recorded in half-hour time intervals using a daily diary at least 3 full days before scheduled visits. For baseline, the 24-hour average over 3 consecutive days was derived for Week -1. For endpoint, the 24-hour average was derived for the last available 3 consecutive days with postbaseline data available during the treatment period. For treatment period visits, the 24-hour average was derived for the final 3 consecutive days with data available for the particular visit. Change from baseline in LS means & pooled SD were obtained from an ANCOVA model with effect for treatment & baseline covariate. A (+) change from baseline signifies more time spent in the on state (no dyskinesias)."|Baseline (Week -1) and Weeks 2, 4, 6, 8, 10, 12|"The Efficacy Population consisting of all treated participants who had post-baseline data (awake time per day in the on state with no dyskinesias) for the assessment week was used for analysis."||hours/day||Standard Deviation|Least Squares Mean
731729|NCT00406029|Secondary|"Change From Baseline in Awake Time Per Day Spent in the on State"|"On time refers to periods of adequate control of Parkinson disease symptoms (symptoms better or absent). Hours spent in the on state during awake time were recorded in half-hour time intervals using a daily diary at least 3 full days before scheduled visits. For baseline, the 24-hour average over 3 consecutive days was derived for Week -1. For endpoint, the 24-hour average was derived for the last available 3 consecutive days with postbaseline data available during the treatment period. For treatment period visits, the 24-hour average was derived for the final 3 consecutive days with data available for the particular visit. Change from baseline in LS means and pooled SD were obtained from an ANCOVA model with effect for treatment and baseline covariate. A positive (+) change from baseline signifies more time spent in the on state."|Baseline (Week -1) and Weeks 2, 4, 6, 8, 10, 12|"The Efficacy Population consisting of all treated participants who had post-baseline data (awake time per day in the on state) for the assessment week was used for analysis."||hours/day||Standard Deviation|Least Squares Mean
731730|NCT00406029|Secondary|"Change From Baseline in Awake Time Per Day Spent in the Off State at Each Visit"|"Off time refers to periods of inadequate control of Parkinson disease symptoms (worsening or presence of symptoms). Hours spent in the off state during awake time were recorded in half-hour time intervals using a daily diary at least 3 full days before scheduled visits. For baseline, the 24-hour average over 3 consecutive days was derived for Week -1. For treatment period visits, the 24-hour average was derived for the final 3 consecutive days with data available for the particular visit. Change from baseline in LS means and pooled SD were obtained from an ANCOVA model with treatment effect and baseline covariate. A negative change from baseline signifies less time spent in the off state."|Baseline (Week -1) and Weeks 2, 4, 6, 8, 10, 12|"The Efficacy Population consisting of all treated participants who had post-baseline data (awake time per day in the off state) for the assessment week was used for analysis."||hours/day||Standard Deviation|Least Squares Mean
731731|NCT00406029|Primary|"Change From Baseline to Endpoint of 12 Weeks in the 3-day Average of Awake Time Per Day Spent in the Off State"|"Off time refers to periods of inadequate control of Parkinson disease symptoms (worsening or presence of symptoms). For baseline and the 12 weeks treatment period, hours spent in the off state during awake time were recorded in half-hour time intervals using a daily diary at least 3 full days before scheduled visits. For baseline, the 24-hour average over 3 consecutive days was derived for Week -1. For endpoint, the 24-hour average was derived for the last available 3 consecutive days with postbaseline data available during the treatment period. Change from baseline in least squares (LS) means and pooled standard deviation (SD) were obtained from an analysis of covariance (ANCOVA) model with effect for treatment and baseline covariate. A negative change from baseline signifies less time spent in the off state."|Baseline (Week -1) and up to 12 weeks|"The Efficacy Population consisting of all treated participants who had post-baseline data (awake time per day in the off state) was used for analysis."||hours/day||Standard Deviation|Least Squares Mean
731732|NCT00398983|Primary|Number of Participants With Relapse-Free Response at 1 Year|Relapse free response defined an absence of relapse at one year of follow up.|Baseline to 1 year|||participants|||Number
731733|NCT00399035|Secondary|Time to Wound Healing Complications|Number of days from post-randomisation surgery until wound healing complications|Post-randomisation until end of study|Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation. The decision was taken to continue with cediranib 20 mg. All efficacy analyses compared cediranib 20mg to placebo. No statistical analyses were performed on the 30mg group.||Days||Full Range|Median
731734|NCT00399035|Secondary|Rate of Resection of Liver Metastases|Number of patients undergoing liver resection, based on patients with liver disease at baseline|Post-randomisation until end of study|Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation. The decision was taken to continue with cediranib 20 mg. All efficacy analyses compared cediranib 20mg to placebo. No statistical analyses were performed on the 30mg group.||Participants|||Number
731735|NCT00399035|Secondary|Duration of Response|Based on RECIST measurements taken throughout the study and best objective tumour response at the defined analysis cut-off point. Measured from the time the criteria for CR/PR are first met (whichever is recorded first) until the patient progresses or dies.|Treatment period from initial response up until data cut-off date of 21/03/10|Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation. The decision was taken to continue with cediranib 20 mg. All efficacy analyses compared cediranib 20mg to placebo. No statistical analyses were performed on the 30mg group.||Months||Inter-Quartile Range|Median
731736|NCT00399035|Secondary|Best Percentage Change in Tumour Size|Maximum percentage reduction or minimum percentage increase in tumour size where size is the sum of the longest diameters of the target lesions|Baseline through to date of death upto and including data cut off date of 21/03/10|Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation. The decision was taken to continue with cediranib 20 mg. All efficacy analyses compared cediranib 20mg to placebo. No statistical analyses were performed on the 30mg group.||Percentage [change in tumour size (mm) ]||Standard Deviation|Mean
731737|NCT00399035|Secondary|Overall Response Rate|Objective tumour response(defined as a confirmed response of CR or PR).The definition for a confirmed response was met when an initial RECIST response of PR/CR was confirmed at the next scheduled visit as a PR/CR according to an evaluable assessment.Intervening assessments of non-evaluable or stable disease were allowable as long as the initial RECIST response was confirmed.RECIST criteria defined as follows: Target lesions Complete Response(CR)Disappearance of all target lesions Partial Response (PR).At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD. Progressive Disease (PD) At least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded (either at baseline or at previous assessment since treatment began).Stable Disease (SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.Non-target lesions Complete Response (CR) Disappearance of all non-target lesi|Baseline through to date of death upto and including data cut off date of 21/03/10|Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation. The decision was taken to continue with cediranib 20 mg. All efficacy analyses compared cediranib 20mg to placebo. No statistical analyses were performed on the 30mg group.||Participants|||Number
731738|NCT00399035|Primary|Overall Survival|Number of months from randomisation to the date of death from any cause|Baseline through to date of death upto and including data cut off date of 21/03/10|Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation. The decision was taken to continue with cediranib 20 mg. All efficacy analyses compared cediranib 20mg to placebo. No statistical analyses were performed on the 30mg group.||Months||Inter-Quartile Range|Median
731739|NCT00399035|Primary|Progression-free Survival|RECIST criteria defined as follows: Target lesions Complete Response (CR) Disappearance of all target lesions Partial Response (PR) At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD.Progressive Disease (PD) At least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded (either at baseline or at previous assessment since treatment began).Stable Disease (SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Non-target lesions Complete Response (CR) Disappearance of all non-target lesions Non-Complete Response (non-CR/Non- Progression [non-PD]) Persistence of one or more non-target lesion or/and maintenance of tumour marker level above the normal limits. Progression (PD) Unequivocal progression of existing nontarget lesions.|RECIST assessed at baseline every 6 weeks through to week 24 and 12 week thereafter through to progression or data cut off date of 21/03/10 whichever was earliest.|Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation.The decision was taken to continue with cediranib 20 mg. All efficacy analyses compared cediranib 20mg to placebo. No statistical analyses were performed on the 30mg group.||Months||Inter-Quartile Range|Median
731740|NCT00399308|Secondary|Secondary Efficacy: Cumulative Proportion of Patients Completely Healed by the End of the Follow-up Period (24 Weeks).|The proportion of patients achieving wound closure by the end of the study follow-up period, 90 days after the end of the active treatment period.|24 weeks|Intent-to-Treat population||participants|||Number
731743|NCT00399308|Primary|Primary Efficacy: Cumulative Proportion of Patients Completely Healed by the End of the Treatment Period, as Judged by the Investigator’s Direct Observation.|The primary efficacy observation was the proportion of wounds that achieved complete wound closure after 12 weeks of active treatment (i.e. of of Week 15 including screening/wash-in phase.)|12 weeks|Intent-to-Treat population (i.e. all subjects randomized to treatment)||participants|||Number
731744|NCT00399360|Secondary|Intramyocellular Lipid|Intramyocellular lipid (IMCL) of the tibialis anterior was determined using 1H-magnetic resonance spectroscopy (Siemens, Munich, Germany). The change in the intramyocellular lipid measurement between baseline and 12 months is reported.|baseline and 12 months|||mmol/kg||Standard Error|Mean
731745|NCT00399360|Secondary|Cardiorespiratory Fitness|A submaximal exercise stress test was conducted on a cycle ergometer to measure endurance. Subjects cycled between 50-60 revolutions per minute and the workload was progressively increased in increments of 50 watts in stages lasting 3 minutes. Once subjects became fatigued or reached their submaximal heart rate (220-age x 85), the test was stopped and separate readings of heart rate and blood pressure were measured at 1, 3, and 5 min of recovery. Weight-adjusted maximum oxygen consumption (VO2max; ml/kg per minute) was determined. The change in cardiorespiratory fitness between baseline and 12 months is reported.|baseline and 12 months|All data were included in the analysis by intention to treat principle. For participants who did not complete a 12-month visit, last observation carried forward was performed for those participants for whom interim data post the baseline visit was available.||ml/kg/min||Standard Error|Mean
731746|NCT00399360|Secondary|Abdominal Visceral Adiposity|Abdominal visceral adipose area was assess by magnetic resonance imaging at the lvel of the L4 pedicle. The change in abdominal visceral adiposity between baseline and 12 months is reported.|baseline and 12 months|||cm2||Standard Error|Mean
731747|NCT00399360|Secondary|C-reactive Protein|High sensitivity C-reactive protein was determined by R&D Systems (Minneapolis, MN) kit. The change in C-reactive protein between baseline and 12 months is reported.|baseline and 12 months|||mg/l||Standard Error|Mean
731748|NCT00399360|Primary|Coronary Artery Calcium Score|Computed tomography (CT) imaging was performed using a SOMATOM Sensation (Siemens Medical Solutions, Forcheim, Germany) 64-slice CT scanner. Agatston calcium score was calculated using CT images. The total Agatston score is calculated by summing up the scores of the individual calcifications in all slices of the CT scan. An absolute Agatston score of less than 10 indicates minimal overall atherosclerosis (plaques) in the coronary arteries. The change in the coronary artery calcium score between baseline and 12 months is reported.|baseline and 12 months|All data were included in the analysis by intention to treat principle. For participants who did not complete a 12-month visit, last observation carried forward was performed for those participants for whom interim data post the baseline visit was available.||Agatston score||Standard Error|Mean
731749|NCT00399360|Primary|Systolic Blood Pressure|Systolic blood pressure was measured after 5 minutes rest. The in systolic blood pressure between baseline and 12 months is reported.|baseline and 12 months|||mm Hg||Standard Error|Mean
731750|NCT00399360|Primary|Glucose|Glucose level was determined after an overnight fast. The change in glucose between baseline and 12 months is reported.|baseline and 12 months|||mg/dL||Standard Error|Mean
731751|NCT00399360|Primary|High Density Lipoprotein (HDL)|High density lipoprotein (HDL) was determined after an overnight fast. The change in HDL between baseline and 12 months is reported.|baseline and 12 months|All data were included in the analysis by intention to treat principle. For participants who did not complete a 12-month visit, last observation carried forward was performed for those participants for whom interim data post the baseline visit was available.||mg/dL||Standard Error|Mean
731752|NCT00399360|Primary|Waist Circumference|Iliac waist circumference measurements were obtained using an inelastic tape measure. All measurements were obtained in triplicate, with the patient undressed, and then averaged. The change of the waist circumference measurement between baseline and 12 months is reported.|baseline and 12 months|All data were included in the analysis by intention to treat principle. For participants who did not complete a 12-month visit, last observation carried forward was performed for those participants for whom interim data post the baseline visit was available.||cm||Standard Error|Mean
731753|NCT00399360|Primary|Carotid Intima Media Thickness|Carotid intima media thickness imaging of the common carotid artery was conducted using a high-resolution 7.5-MHz phased-array transducer (SONOS 2000/2500. The change of the carotid intima media thickness measurement between baseline and 12 months is reported.|baseline and 12 months|All data were included in the analysis by intention to treat principle. For participants who did not complete a 12-month visit, last observation carried forward was performed for those participants for whom interim data post the baseline visit was available.||mm||Standard Error|Mean
731754|NCT00399516|Primary|Pain Severity, as Measured on the 11-point (0-10) Numerical Rating Scale (NRS)|"Pain severity as measured by NRS quantifies pain, where 0 is no pain and 10 is worst pain imaginable"|Within 6 months post-implantation|||Percent Change in Pain Rating||Standard Deviation|Mean
731755|NCT00399542|Secondary|Month 3 Bowel Movement Rates Change From Baseline||28 days|ITT, with LOCF||BMs/week||Standard Deviation|Mean
731756|NCT00399542|Secondary|Month 2 Bowel Movement Rates Change From Baseline||28 days|ITT, with LOCF||BMs/week||Standard Deviation|Mean
731757|NCT00399542|Secondary|Month 1 Bowel Movement Rates Change From Baseline||28 days|ITT, with LOCF||bowel movements (BMs)/week||Standard Deviation|Mean
731758|NCT00399542|Secondary|Month 3 Quality of Life Change From Baseline|IBS-QOL questionnaire included 34 questions with 5 possible responses yielding the following sub-categories: dysphoria, interference with activity, body image, health worry, food avoidance, social reaction, sexual, and relationship Results range from 34 (low) to 100 (high); meaningful clinical improvement=14 point increase|12 weeks|ITT without LOCF||units on a scale||Standard Deviation|Mean
731759|NCT00399542|Secondary|Month 3 Symptom Relief|"3 = Significantly worse, -2 = Moderately worse,
1 = A little bit worse, 0 = Unchanged, 1 = A little bit relieved, 2 = Moderately relieved, 3 = Significantly relieved"|28 days|ITT with LOCF||units on a scale||Standard Deviation|Mean
731760|NCT00399542|Secondary|Month 2 Symptom Relief|"3 = Significantly worse, -2 = Moderately worse,
1 = A little bit worse, 0 = Unchanged, 1 = A little bit relieved, 2 = Moderately relieved, 3 = Significantly relieved"|28 days|ITT with LOCF||units on a scale||Standard Deviation|Mean
731761|NCT00399542|Secondary|Month 3 Constipation Severity Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|28 days|ITT with LOCF||units on a scale||Standard Deviation|Mean
731775|NCT00399542|Secondary|Month 3 Responder Rate|"Monthly responder: >=Moderately relieved symptoms 4 weeks/month or Significantly relieved >= 2 weeks/month IF:
Rescue med use did not increase; AND patient did not discontinue during the month for lack of efficacy; AND no Moderately worse or Significantly worse response in month."|28 days|ITT without LOCF||percentage of participants|||Number
731776|NCT00399542|Secondary|Month 2 Responder Rate|"Monthly responder: >=Moderately relieved symptoms 4 weeks/month or Significantly relieved >= 2 weeks/month IF:
Rescue med use did not increase; AND patient did not discontinue during the month for lack of efficacy; AND no Moderately worse or Significantly worse response in month."|28 days|ITT without LOCF||percentage of participants|||Number
731777|NCT00399542|Secondary|Month 1 Responder Rate|"Monthly responder: >=Moderately relieved symptoms 4 weeks/month or Significantly relieved >= 2 weeks/month IF:
Rescue med use did not increase; AND patient did not discontinue during the month for lack of efficacy; AND no Moderately worse or Significantly worse response in month."|28 days|ITT without LOCF||percentage of participants|||Number
731778|NCT00399542|Secondary|Month 1 Symptom Relief|"3 = Significantly worse, -2 = Moderately worse,
1 = A little bit worse, 0 = Unchanged, 1 = A little bit relieved, 2 = Moderately relieved, 3 = Significantly relieved"|28 days|ITT with LOCF||units on a scale||Standard Deviation|Mean
731779|NCT00399542|Secondary|Month 1 Constipation Severity Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|28 days|ITT with LOCF||units on a scale||Standard Deviation|Mean
731780|NCT00399542|Secondary|Month 1 Bowel Straining Change From Baseline|0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|28 days|ITT with LOCF||units on a scale||Standard Deviation|Mean
731781|NCT00399542|Secondary|Month 1 Stool Consistency Change From Baseline|0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)|28 days|ITT with LOCF||units on a scale||Standard Deviation|Mean
731782|NCT00399542|Secondary|Month 1 Spontaneous Bowel Movement Rates Change From Baseline|Any bowel movement not associated with rescue medication use|28 days|ITT with LOCF||spontaneous bowel movements (SBMs)/week||Standard Deviation|Mean
731783|NCT00399542|Primary|Overall Responder Status|"Overall responder: monthly responder for at least 2 out of 3 months
Monthly responder: >=Moderately relieved symptoms 4 weeks/month or Significantly relieved >= 2 weeks/month IF:
Rescue med use did not increase; AND patient did not discontinue during the month for lack of efficacy; AND no Moderately worse or Significantly worse response in month."|12 weeks|Intention to treat (ITT), without Last Observational Carried Forward (LOCF).||percentage of participants|||Number
731784|NCT00399568|Secondary|Subjects Who Experienced at Least One Treatment-emergent Serious Adverse Event.|"Number of subjects who reported SAEs during the study.
A serious Adverse event (SAE) is defined as any untoward medical occurence at any dose of study medication that:
Results in Death, Is Life Threatening, Requires inpatient hospitalization or causes prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Is a congenital anomaly/birth defect, or Is an important medical event"|32 days following first dose of study medication.|||Subjects|||Number
731785|NCT00399568|Primary|Sum Pain Intensity at Rest-Baseline to 48 Hours (SPI48rest), 1 Gram IV Acetaminophen vs. Placebo|"The Sum of Pain Intensity (SPI) score incorporates the analgesic effects on pain intensity (PI) from Baseline to 48 hours. SPI was measured by the 100 millimeter (mm) long Visual Analog Scale (VAS) over 48 hours after treatment. Subjects were asked to mark the level of pain they were experiencing at a certain timepoint on the scale The 100 mm VAS scale was used with the left terminus (0 mm) of the scale No Pain and the right terminus (100 mm) with Worst Pain Imaginable. The range of measurement is 0-4800 mm for 48 hours."|Baseline (just prior to the first dose) through 48 hours|All efficacy analyses were conducted using the mITT population, defined as those subjects who received a complete dose of study medication prior to a request for rescue medication.||units on a scale (in millimeters)||Standard Deviation|Mean
731786|NCT00399568|Secondary|Subjects Who Experienced at Least One Treatment-emergent Adverse Event (TEAE)|Number of subjects who experienced at least one treatment emergent adverse event (TEAE) A TEAE is an adverse event that occurs on or after administration of the first dose of study medication (T0)|First dose through 7 day follow up|All analyses of safety were conducted on the Safety population, which included those subjects who received any portion of a dose of study medication.||Subjects|||Number
731787|NCT00399568|Primary|Sum of Pain Intensity at Rest-Baseline to 24 Hours (SPI24rest), 1 Gram IV Acetaminophen vs. Placebo.|"The Sum of Pain Intensity (SPI) score incorporates the analgesic effects on pain intensity (PI) from Baseline to 24 hours. SPI was measured by the 100 millimeter (mm) long Visual Analog Scale (VAS) over 24 hours after treatment. Subjects were asked to mark the level of pain they were experiencing at a certain timepoint on the scale The 100mm VAS scale was used with the left terminus (0 mm) of the scale No Pain and the right terminus (100 mm) with Worst Pain Imaginable. The range of measurement is 0-2400 mm for 24 hours."|Baseline (just prior to the first dose) through 24 hours|All efficacy analyses were conducted using the mITT population, defined as those subjects who received a complete dose of study medication prior to a request for rescue medication.||units on a scale (in millimeters)||Standard Deviation|Mean
731788|NCT00399763|Secondary|Side Effect Form for Children and Adolescents (SEFCA)|The SEFCA is a clinician-administered instrument that systematically assesses 52 possible side effects and rates them on a scale of 0 (not present) to 3 (severe). The instrument relies on confidential, self-report of the adolescent.The number of serious adverse events was recorded by intervention assignment.|weekly from randomization to 12 weeks post-randomization|||Number of serious adverse events|||Number
731789|NCT00399763|Secondary|Time Line Followback Interview (TLFB)|The TLFB assesses the number of days in which a substance was used in the past 28 days. The TLFB is administered by the clinician and uses a 28-day calendar with anchor points to record this information. This instrument relies on confidential self-report of the adolescent participant. The result is reported as mean change in the number of days used substances in the past 28 days from baseline to the end of treatment using linear mixed models in an intent-to-treat analysis.|12 weeks|||days||95% Confidence Interval|Mean
731790|NCT00399763|Primary|Change in Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) Attention-deficit/Hyperactivity Disorder (ADHD) Checklist|All 18 ADHD symptoms are rated on a scale of 0 (none) to 3 (severe) since the previous study visit. The scores are summed to create a total ADHD severity scale score ranging from 0 (none) to 54 (most severe). A single value of mean change in ADHD severity for each group (placebo and atomoxetine) was calculated using linear mixed models in an intent-to-treat an analysis.|baseline and weekly through week 12 post randomization|||units on a scale||95% Confidence Interval|Mean
731791|NCT00399880|Secondary|Self-Efficacy for Appropriate Medication Use Scale (SEAMS)|Validated measure of confidence in taking medications correctly. Possible range 13-39, with higher values indicating greater confidence.|Approximately 2 weeks after hospital discharge|Participants who were able to be contacted and provided outcome data.||units on a scale||Standard Deviation|Mean
731792|NCT00399880|Primary|Adherence to Refills and Medications Scale (ARMS)|Validated self-report measure of medication adherence. Possible range 12-48, with lower values indicating better adherence.|Approximately 2 weeks after hospital discharge|Participants who were able to be contacted and provided outcome data.||units on a scale||Standard Deviation|Mean
731793|NCT00399893|Primary|Number of Participants With Improved Peptide YY (PYY) Regulation From Baseline to 6 Months|Number of participants with improved Peptide YY (PYY) regulation from baseline to 6 months of Octreotide or Placebo therapy|6 months|Participant withdrew but data was used for analysis||participants|||Number
731794|NCT00399893|Primary|Number of Participants With Improved Leptin Regulation From Baseline to 6 Months|Number of participants with improved Leptin regulation from baseline to 6 months of Octreotide or Placebo therapy|6 months|||participants|||Number
731795|NCT00399893|Primary|Number of Participants With Improved Adiponectin Regulation From Baseline to 6 Months|Number of participants with improved Adiponectin regulation from baseline to 6 months of Octreotide or Placebo therapy|6 months|A participant withdrew but data was used for analysis||participants|||Number
731796|NCT00399893|Primary|Number of Participants With Improved Insulin Regulation From Baseline to 6 Months|Number of participants with improved Insulin regulation from baseline to 6 months of Octreotide or Placebo therapy. Insulin regulation was measured by immunochemiluminescent assay.|6 months|Participant withdrew but was used in the data analysis||participants|||Number
731797|NCT00399893|Secondary|Number of Participants With Decreased Body-composition From Baseline to 6 Months by DEXA|Number of participants with decreased body-composition as Measured by Dual Energy X-ray Absorptiometry (DEXA) scan from baseline to 6 months of Octreotide or Placebo therapy|6 months|Data for this outcome was not analyzed||participants|||Number
731798|NCT00399893|Primary|Number of Participants With Decrease in Hunger and Food Intake|Measured by hunger and hyperphagia by questionnaires and parent-reported 72-hour food recall from baseline to 6 months. Multiple questionnaires consisting of a battery of free text answer questions and food diaries are combined in order to make a behavioral assessment of the participants food state of hunger and food intake. There is no defined scale for this assessment. Each participants responses and parent responses are combined.|6 months|For this outcome measure, data from questionnaires and forms was not completed. Data for all questionnaires is not available to report.|||||
731799|NCT00399893|Primary|Number of Participants With Decreased Skin-fold Measurements From Baseline to 6 Months|Number of participants with decreased skin-fold measurements from baseline to 6 months of Octreotide or Placebo therapy|6 months|The skin fold measurements were performed; however, the data was not completed in a manner that could be analyzed; therefore we could not analyze the data. Completed data is not available to complete this outcome.|||||
731800|NCT00399893|Primary|Number of Participants With Decreased BMI Z-score From Baseline to 6 Months|Number of participants with decreased BMI z-score from baseline to 6 months of Octreotide or Placebo therapy|6 months|A participant withdrew but was included in analysis||participants|||Number
731801|NCT00399893|Primary|Number of Participants With Decrease in Weight From Baseline to 6 Months|Number of participants who had a decrease in weight from baseline to 6 months of Octreotide or placebo therapy|6 months|||participants|||Number
731802|NCT00399893|Secondary|Number of Participants With Decreased Body Composition From Baseline to 6 Months by BOD POD®|Number of participants with decreased body-composition as Measured by BOD POD® body composition tracking system from baseline to 6 months of Octreotide or Placebo therapy|6 months|Participant withdrew but data was used for analysis||participants|||Number
731803|NCT00399893|Primary|Number of Participants With Decrease in Fasting Total Ghrelin|Number of participants showing a decrease in Fasting total ghrelin from baseline to 6 months of treatment with Octreotide or placebo|6 months|"Descriptive statistics or percent of change from the baseline for the 5 patients was used.
A patient withdrew but included in analysis."||Participants|||Number
731804|NCT00400153|Secondary|Cumulative Amounts of Albuterol [μg] Excreted in Urine for 0-6 Hours|Cumulative amounts of Albuterol [μg] excreted in urine - Planned time intervals 0−6, ss|Before drug administration to 6 hours after drug administration on Day 29|All patients in FAS who were from U.S. study sites and whose blood and/or urine samples were collected at Visit 3 according to the protocol||μg||Geometric Coefficient of Variation|Geometric Mean
731805|NCT00400153|Secondary|Cumulative Amounts of Ipratropium [μg] Excreted in Urine for 0-6 Hours|Cumulative amounts of Ipratropium [μg] excreted in urine - Planned time intervals 0−6,ss|Before drug administration to 6 hours after drug administration on Day 26|All patients in FAS who were from U.S. study sites and whose blood and/or urine samples were collected at Visit 3 according to the protocol||μg||Geometric Coefficient of Variation|Geometric Mean
731806|NCT00400153|Secondary|Cumulative Amounts of Albuterol [μg] Excreted in Urine for 0-2 Hours|Cumulative amounts of Albuterol [μg] excreted in urine - Planned time intervals 0−2,ss.|Before drug administration to 2 hours after drug administration on Day 29|All patients in FAS who were from U.S. study sites and whose blood and/or urine samples were collected at Visit 3 according to the protocol||μg||Geometric Coefficient of Variation|Geometric Mean
731807|NCT00400153|Secondary|Cumulative Amounts of Ipratropium [μg] Excreted in Urine for 0-2 Hours|Cumulative amounts of Ipratropium [μg] excreted in urine - Planned time intervals 0-2, ss|Before drug administration to 2 hours after drug administration on Day 29|All patients in FAS who were from U.S. study sites and whose blood and/or urine samples were collected at Visit 3 according to the protocol||μg||Geometric Coefficient of Variation|Geometric Mean
731808|NCT00400153|Secondary|Noncompartmental Parameters of Albuterol at Steady State|Geometric mean area under the plasma drug concentration time curve over one dosing interval (AUCτ). Each patient had eight plasma samples (trough pre-dose, 5, 15, 30, and 60 minutes post-dose, as well as 2, 4, and 6 hours post-dose).|Before drug administration to 6 hours after drug administration on Day 29|All patients in FAS who were from U.S. study sites and whose blood and/or urine samples were collected at Visit 3 according to the protocol||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
734974|NCT00429364|Secondary|Annual Rate of Change in Height||Up to 3 years following randomization.|All randomized participants whose heights were measured at baseline and at any of the follow-up visits.||cm/year||Standard Error|Least Squares Mean
731809|NCT00400153|Secondary|Noncompartmental Pharmacokinetic Parameters of Ipratropium at Steady State|Geometric mean area under the plasma drug concentration time curve over one dosing interval (AUCτ). Each patient had eight plasma samples (trough pre-dose, 5, 15, 30, and 60 minutes post-dose, as well as 2, 4, and 6 hours post-dose).|Before drug administration to 6 hours after drug administration on Day 29|All patients in FAS who were from U.S. study sites and whose blood and/or urine samples were collected at Visit 3 according to the protocol.||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
731810|NCT00400153|Secondary|Rating of Action of Turning Clear Base of Respimat|Frequency of patients due to rating of action of turning clear base of Respimat|12 weeks|Treated set (US patients)||participants|||Number
731811|NCT00400153|Secondary|Device Preference (Respimat or MDI)|Frequency of patients due to device preference|12 weeks|Treated set (US patients)||participants|||Number
731812|NCT00400153|Secondary|Mean Rating Scores of Satisfaction With Inhaler - Overall Satisfaction With Inhaler|"Patients rated their response on a seven point Likert scale:
1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied."|12 weeks|Treated set (US patients)||units on a scale||Standard Error|Mean
731813|NCT00400153|Secondary|Mean Rating Scores of Satisfaction With Inhaler - Speed of Medicine Coming Out of the Inhaler|"Patients rated their response on a seven point Likert scale:
1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied."|12 weeks|Treated set (US patients)||units on a scale||Standard Error|Mean
731814|NCT00400153|Secondary|Mean Rating Scores of Satisfaction With Inhaler - Using the Inhaler|"Patients rated their response on a seven point Likert scale:
1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied."|12 weeks|Treated set (US patients)||units on a scale||Standard Error|Mean
731815|NCT00400153|Secondary|Mean Rating Scores of Satisfaction With Inhaler - The Inhaler is Durable|"Patients rated their response on a seven point Likert scale:
1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied."|12 weeks|Treated set (US patients)||units on a scale||Standard Error|Mean
731816|NCT00400153|Secondary|Mean Rating Scores of Satisfaction With Inhaler - Instructions for Use|"Patients rated their response on a seven point Likert scale:
1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied."|12 weeks|Treated set (US patients)||units on a scale||Standard Error|Mean
731817|NCT00400153|Secondary|Mean Rating Scores of Satisfaction With Inhaler - Ease of Inhaling a Dose From the Inhaler|"Patients rated their response on a seven point Likert scale:
1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied."|12 weeks|Treated set (US patients)||units on a scale||Standard Error|Mean
731818|NCT00400153|Secondary|Mean Rating Scores of Satisfaction With Inhaler - The Inhaler Works Reliably|"Patients rated their response on a seven point Likert scale:
1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied."|12 weeks|Treated set (US patients)||units on a scale||Standard Error|Mean
731819|NCT00400153|Secondary|Mean Rating Scores of Satisfaction With Inhaler - Telling the Amount of Medication Left|"Patients rated their response on a seven point Likert scale:
1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied."|12 weeks|Treated set (US patients)||units on a scale||Standard Error|Mean
731820|NCT00400153|Secondary|Mean Rating Scores of Satisfaction With Inhaler - Feeling That the Inhaled Dose Goes to the Lung|"Patients rated their response on a seven point Likert scale:
1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied."|12 weeks|Treated set (US patients)||units on a scale||Standard Error|Mean
731821|NCT00400153|Secondary|Mean Rating Scores of Satisfaction With Inhaler - Overall Feeling of Inhaling Medicine|"Patients rated their response on a seven point Likert scale:
1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied."|12 weeks|Treated set (US patients)||units on a scale||Standard Error|Mean
731822|NCT00400153|Secondary|Frequency Distribution of Satisfaction Rating With Inhaler Attributes||12 weeks|Treated set (US patients)||participants|||Number
731823|NCT00400153|Secondary|COPD Exacerbation During the On-treatment Period|COPD exacerbation is defined as an increase or new onset of more than one of the following respiratory symptoms (cough, sputum, sputum purulence, wheezing, dyspnea, and chest tightness) having a duration of three or more days requiring treatment with an antibiotic and/or systemic steroids with or without hospital admission.|During the 12-week on-treatment period|Treated Set||Percentage of patients|||Number
731824|NCT00400153|Secondary|COPD Exacerbation Rate During the On-treatment Period|Proportion of patients experiencing a COPD exacerbation per patient year. COPD exacerbation is defined as an increase or new onset of more than one of the following respiratory symptoms (cough, sputum, sputum purulence, wheezing, dyspnea, and chest tightness) having a duration of three or more days requiring treatment with an antibiotic and/or systemic steroids with or without hospital admission.|During the 12-week on-treatment period|Treated Set||Proportion of patients|||Number
731825|NCT00400153|Secondary|Percentage of Patients With Chronic Obstructive Pulmonary Disease (COPD) Exacerbation During the On-treatment Period|COPD exacerbation is defined as an increase or new onset of more than one of the following respiratory symptoms (cough, sputum, sputum purulence, wheezing, dyspnea, and chest tightness) having a duration of three or more days requiring treatment with an antibiotic and/or systemic steroids with or without hospital admission.|During the 12-week on-treatment period|Treated Set||Percentage of patients|||Number
731826|NCT00400153|Secondary|Physician's Global Evaluation Score on Pulmonary Function Testing Day 85|"Physician's Global Evaluation score is based on the need for concomitant medication, number and severity of exacerbations since the last visit, severity of cough, ability to exercise, amount of wheezing, etc.
Score: 1,2 = poor; 3,4 = fair; 5,6 =good; 7,8 = excellent."|Prior to pulmonary function test on Day 85|Treated Set||units on a scale||Standard Error|Least Squares Mean
731827|NCT00400153|Secondary|Physician's Global Evaluation Score on Pulmonary Function Testing Day 57|"Physician's Global Evaluation score is based on the need for concomitant medication, number and severity of exacerbations since the last visit, severity of cough, ability to exercise, amount of wheezing, etc.
Score: 1,2 = poor; 3,4 = fair; 5,6 =good; 7,8 = excellent."|Prior to pulmonary function test on Day 57|Treated Set||units on a scale||Standard Error|Least Squares Mean
731828|NCT00400153|Secondary|Physician's Global Evaluation Score on Pulmonary Function Testing Day 29|"Physician's Global Evaluation score is based on the need for concomitant medication, number and severity of exacerbations since the last visit, severity of cough, ability to exercise, amount of wheezing, etc.
Score: 1,2 = poor; 3,4 = fair; 5,6 =good; 7,8 = excellent."|Prior to pulmonary function test on Day 29|Treated Set||units on a scale||Standard Error|Least Squares Mean
731829|NCT00400153|Secondary|Trough Peak Expiratory Flow Rate (PEFR)|The weekly mean trough PEFR during the entire study (including baseline and on-treatment period)|During the 2-week baseline washout period and the 12-week treatment period and PEFR taken before administration of study medication|Full Analysis Set for Diary Data||liters/min||Standard Error|Least Squares Mean
731830|NCT00400153|Secondary|Daytime Symptom Score|"The weekly mean daytime symptom score per week during the entire study (including baseline and on-treatment period).
Daytime COPD symptoms: 0=none 1=occasional 2=frequent, no interference with activities 3=most of day, interference with activities 4=prevent working and activities"|During the 2-week baseline washout period and the 12-week treatment period|Full Analysis Set for Diary Data||units on a scale||Standard Error|Least Squares Mean
731831|NCT00400153|Secondary|Night-time Symptom Score|"The weekly mean night-time symptom score per week during the entire study (including baseline and on-treatment period).
Night−time COPD symptoms: 0=none 1=some − slept well 2=woke once 3=woke several times 4=woke most of night"|During the 2-week baseline washout period and the 12-week treatment period|Full Analysis Set for Diary Data||units on a scale||Standard Error|Least Squares Mean
731832|NCT00400153|Secondary|Daytime Rescue Medication Use|The mean number of puffs of rescue medication used during the daytime per week during the entire study (including baseline and on-treatment period)|During the 2-week baseline washout period and the 12-week treatment period|Full Analysis Set for Diary Data||puffs||Standard Error|Least Squares Mean
731833|NCT00400153|Secondary|Night-time Rescue Medication Use|The mean number of puffs of rescue medication used during the night-time per week during the entire study (including baseline and on-treatment period)|During the 2-week baseline washout period and the 12-week treatment period|Full Analysis Set for Diary Data||puffs||Standard Error|Least Squares Mean
731834|NCT00400153|Secondary|Rescue Medication Use on Pulmonary Test Day 85|Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 85|During the 6-hour pulmonary function testing after drug administration on Day 85|Treated Set||patients|||Number
731835|NCT00400153|Secondary|Rescue Medication Use on Pulmonary Test Day 57|Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 57|During the 6-hour pulmonary function testing after drug administration on Day 57|Treated Set||patients|||Number
731836|NCT00400153|Secondary|Rescue Medication Use on Pulmonary Test Day 29|Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 29|During the 6-hour pulmonary function testing after drug administration on Day 29|Treated Set||patients|||Number
731837|NCT00400153|Secondary|Rescue Medication Use on Pulmonary Test Day 1|Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 1|During the 6-hour pulmonary function testing after drug administration on Day 1|Treated Set||patients|||Number
731838|NCT00400153|Secondary|Peak FVC Response at Day 85|Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 85|Within the first 2-hour post-treatment interval at Day 85|Full Analysis Set for Pulmonary Function Test Data||liters||Standard Error|Least Squares Mean
731839|NCT00400153|Secondary|Peak FVC Response at Day 57|Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 57|Within the first 2-hour post-treatment interval at Day 57|Full Analysis Set for Pulmonary Function Test Data||liters||Standard Error|Least Squares Mean
731840|NCT00400153|Secondary|Peak FVC Response at Day 29|Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 29|Within the first 2-hour post-treatment interval at Day 29|Full Analysis Set for Pulmonary Function Test Data||liters||Standard Error|Least Squares Mean
731841|NCT00400153|Secondary|Peak FVC Response at Day 1|Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 1|Within the first 2-hour post-treatment interval at Day 1|Full Analysis Set for Pulmonary Function Test Data||liters||Standard Error|Least Squares Mean
731842|NCT00400153|Secondary|Peak FVC Response at Day 85|Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 85|Within the first 2-hour post-treatment interval at Day 85|Full Analysis Set for Pulmonary Function Test Data||liters||Standard Error|Least Squares Mean
731843|NCT00400153|Secondary|Peak FVC Response at Day 57|Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 57|Within the first 2-hour post-treatment interval at Day 57|Full Analysis Set for Pulmonary Function Test Data||liters||Standard Error|Least Squares Mean
731844|NCT00400153|Secondary|Peak FVC Response at Day 29|Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 29|Within the first 2-hour post-treatment interval at Day 29|Full Analysis Set for Pulmonary Function Test Data||liters||Standard Error|Least Squares Mean
731845|NCT00400153|Secondary|Peak FVC Response at Day 1|Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 1|Within the first 2-hour post-treatment interval at Day 1|Full Analysis Set for Pulmonary Function Test Data||liters||Standard Error|Least Squares Mean
731846|NCT00400153|Secondary|FVC AUC4-6 at Day 85|Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 85|Between 4 hours and 6 hours after drug administration on Day 85|Full Analysis Set for Pulmonary Function Test Data 4-6 hours||liters||Standard Error|Least Squares Mean
731847|NCT00400153|Secondary|FVC AUC4-6 at Day 57|Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 57|Between 4 hours and 6 hours after drug administration on Day 57|Full Analysis Set for Pulmonary Function Test Data 4-6 hours||liters||Standard Error|Least Squares Mean
731848|NCT00400153|Secondary|FVC AUC4-6 at Day 29|Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 29|Between 4 hours and 6 hours after drug administration on Day 29|Full Analysis Set for Pulmonary Function Test Data 4-6 hours||liters||Standard Error|Least Squares Mean
731849|NCT00400153|Secondary|FVC AUC4-6 at Day 1|Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 1|Between 4 hours and 6 hours after drug administration on Day 1|Full Analysis Set for Pulmonary Function Test Data 4-6 hours||liters||Standard Error|Least Squares Mean
731850|NCT00400153|Secondary|FVC AUC0-4 at Day 85|Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 85|Before drug administration to 4 hours after drug administration on Day 85|Full Analysis Set for Pulmonary Function Test Data||liters||Standard Error|Least Squares Mean
731851|NCT00400153|Secondary|FVC AUC0-4 at Day 57|Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 57|Before drug administration to 4 hours after drug administration on Day 57|Full Analysis Set for Pulmonary Function Test Data||liters||Standard Error|Least Squares Mean
731852|NCT00400153|Secondary|FVC AUC0-4 at Day 29|Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 29|Before drug administration to 4 hours after drug administration on Day 29|Full Analysis Set for Pulmonary Function Test Data||liters||Standard Error|Least Squares Mean
731853|NCT00400153|Secondary|FVC AUC0-4 at Day 1|Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 1|Before drug administration to 4 hours after drug administration on Day 1|Full Analysis Set for Pulmonary Function Test Data||liters||Standard Error|Least Squares Mean
731854|NCT00400153|Secondary|FVC AUC0-6 at Day 85|Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 85|Before drug administration to 6 hours after drug administration on Day 85|Full Analysis Set for Pulmonary Function Test Data||liters||Standard Error|Least Squares Mean
731855|NCT00400153|Secondary|FVC AUC0-6 at Day 57|Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 57|Before drug administration to 6 hours after drug administration on Day 57|Full Analysis Set for Pulmonary Function Test Data||liters||Standard Error|Least Squares Mean
731856|NCT00400153|Secondary|FVC AUC0-6 at Day 29|Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 29|Before drug administration to 6 hours after drug administration at Day 29|Full Analysis Set for Pulmonary Function Test Data||liters||Standard Error|Least Squares Mean
731857|NCT00400153|Secondary|FVC AUC0-6 at Day 1|Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 1|Before drug administration to 6 hours after drug administration at Day 1|Full Analysis Set for Pulmonary Function Test Data||liters||Standard Error|Least Squares Mean
731858|NCT00400153|Secondary|Time to Peak FEV1 Response at Day 85|The first time point at which the maximum change in recorded FEV1 data from the corresponding test-day baseline occurred during the 6-hours observation period after drug administration at Day 85|Within the 6-hour post-treatment observation period at Day 85|Full Analysis Set for Pulmonary Function Test Data||Minutes||Inter-Quartile Range|Median
731859|NCT00400153|Secondary|Time to Peak FEV1 Response at Day 57|The first time point at which the maximum change in recorded FEV1 data from the corresponding test-day baseline occurred during the 6-hours observation period after drug administration at Day 57|Within the 6-hour post-treatment observation period at Day 57|Full Analysis Set for Pulmonary Function Test Data||Minutes||Inter-Quartile Range|Median
731860|NCT00400153|Secondary|Time to Peak FEV1 Response at Day 29|The first time point at which the maximum change in recorded FEV1 data from the corresponding test-day baseline occurred during the 6-hours observation period after drug administration at Day 29|Within the 6-hour post-treatment observation period at Day 29|Full Analysis Set for Pulmonary Function Test Data||Minutes||Inter-Quartile Range|Median
731861|NCT00400153|Secondary|Time to Peak FEV1 Response at Day 1|The first time point at which the maximum change in recorded FEV1 data from the corresponding test-day baseline occurred during the 6-hours observation period after drug administration at Day 1|Within the 6-hour post-treatment observation period at Day 1|Full Analysis Set for Pulmonary Function Test Data||Minutes||Inter-Quartile Range|Median
731862|NCT00400153|Secondary|Duration of Therapeutic FEV1 Response at Day 85|The time interval between the onset and the the termination of a therapeutic FEV1 response (at least 1.15 times the corresponding test-day baseline value) during the 6-hour observation period at Day 85|During the 6-hour observation period after drug administration at Day 85|Full Analysis Set for Pulmonary Function Test Data||Minutes||Inter-Quartile Range|Median
731863|NCT00400153|Secondary|Duration of Therapeutic FEV1 Response at Day 57|The time interval between the onset and the the termination of a therapeutic FEV1 response (at least 1.15 times the corresponding test-day baseline value) during the 6-hour observation period at Day 57|During the 6-hour observation period after drug administration at Day 57|Full Analysis Set for Pulmonary Function Test Data||Minutes||Inter-Quartile Range|Median
731864|NCT00400153|Secondary|Duration of Therapeutic FEV1 Response at Day 29|The time interval between the onset and the the termination of a therapeutic FEV1 response (at least 1.15 times the corresponding test-day baseline value) during the 6-hour observation period at Day 29|During the 6-hour observation period after drug administration at Day 29|Full Analysis Set for Pulmonary Function Test Data||Minutes||Inter-Quartile Range|Median
731865|NCT00400153|Secondary|Duration of Therapeutic FEV1 Response at Day 1|The time interval between the onset and the the termination of a therapeutic FEV1 response (at least 1.15 times the corresponding test-day baseline value) during the 6-hour observation period at Day 1|During the 6-hour observation period after drug administration at Day 1|Full Analysis Set for Pulmonary Function Test Data||Minutes||Inter-Quartile Range|Median
736550|NCT00442689|Primary|Change in Low-density Lipoprotein (LDL) Levels Over the Study Period|Change in low-density lipoprotein (LDL) levels over the study period (LDL level at study endpoint - baseline LDL level)|6 months|||mg/dL||Standard Deviation|Mean
731866|NCT00400153|Secondary|Time to Onset of Therapeutic FEV1 Response at Day 85|Achievement of recorded FEV1 measurement of at least 1.15 times of the corresponding test-day baseline value at any time during the first 2 hours of observation after drug administration at Day 85|Within the first 2-hour post-treatment interval at Day 85|Full Analysis Set for Pulmonary Function Test Data||Minutes||Inter-Quartile Range|Median
731867|NCT00400153|Secondary|Time to Onset of Therapeutic FEV1 Response at Day 57|Achievement of recorded FEV1 measurement of at least 1.15 times of the corresponding test-day baseline value at any time during the first 2 hours of observation after drug administration at Day 57|Within the first 2-hour post-treatment interval at Day 57|Full Analysis Set for Pulmonary Function Test Data||Minutes||Inter-Quartile Range|Median
731868|NCT00400153|Secondary|Time to Onset of Therapeutic FEV1 Response at Day 29|Achievement of recorded FEV1 measurement of at least 1.15 times of the corresponding test-day baseline value at any time during the first 2 hours of observation after drug administration at Day 29|Within the first 2-hour post-treatment interval at Day 29|Full Analysis Set for Pulmonary Function Test Data||Minutes||Inter-Quartile Range|Median
731869|NCT00400153|Secondary|Time to Onset of Therapeutic FEV1 Response at Day 1|Achievement of recorded FEV1 measurement of at least 1.15 times of the corresponding test-day baseline value at any time during the first 2 hours of observation after drug administration at Day 1|Within the first 2-hour post-treatment interval at Day 1|Full Analysis Set for Pulmonary Function Test Data||Minutes||Inter-Quartile Range|Median
731870|NCT00400153|Secondary|Peak FEV1 Response at Day 85|Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 85|Within the first 2-hour post-treatment interval on Day 85|Full Analysis Set for Pulmonary Function Test Data||liters||Standard Error|Least Squares Mean
731871|NCT00400153|Secondary|Peak FEV1 Response at Day 57|Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 57|Within the first 2-hour post-treatment interval on Day 57|Full Analysis Set for Pulmonary Function Test Data||liters||Standard Error|Least Squares Mean
731872|NCT00400153|Secondary|Peak FEV1 Response at Day 29|Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 29|Within the first 2-hour post-treatment interval on Day 29|Full Analysis Set for Pulmonary Function Test Data||liters||Standard Error|Least Squares Mean
731873|NCT00400153|Secondary|Peak FEV1 Response at Day 1|Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 1|Within the first 2-hour post-treatment interval on Day 1|Full Analysis Set for Pulmonary Function Test Data||liters||Standard Error|Least Squares Mean
731874|NCT00400153|Secondary|Peak FEV1 Response at Day 85|Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 85|Within the first 2-hour post-treatment interval on Day 85|Full Analysis Set for Pulmonary Function Test Data||liters||Standard Error|Least Squares Mean
731875|NCT00400153|Secondary|Peak FEV1 Response at Day 57|Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 57|Within the first 2-hour post-treatment interval on Day 57|Full Analysis Set for Pulmonary Function Test Data||liters||Standard Error|Least Squares Mean
731876|NCT00400153|Secondary|Peak FEV1 Response at Day 29|Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 29|Within the first 2-hour post-treatment interval on Day 29|Full Analysis Set for Pulmonary Function Test Data||liters||Standard Error|Least Squares Mean
731877|NCT00400153|Secondary|Peak FEV1 Response at Day 1|Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 1|Within the first 2-hour post-treatment interval on Day 1|Full Analysis Set for Pulmonary Function Test Data||liters||Standard Error|Least Squares Mean
731878|NCT00400153|Secondary|FEV1 AUC4-6 at Day 57|Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 57|Between 4 hours and 6 hours after drug administration on Day 57|Full Analysis Set for Pulmonary Function Test Data 4-6 hours||liters||Standard Error|Least Squares Mean
731879|NCT00400153|Secondary|FEV1 AUC4-6 at Day 29|Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 29|Between 4 hours and 6 hours after drug administration on Day 29|Full Analysis Set for Pulmonary Function Test Data 4-6 hours||liters||Standard Error|Least Squares Mean
731880|NCT00400153|Secondary|FEV1 AUC4-6 at Day 1|Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 1|Between 4 hours and 6 hours after drug administration on Day 1|Full Analysis Set for Pulmonary Function Test Data 4-6 hours||liters||Standard Error|Least Squares Mean
731881|NCT00400153|Secondary|FEV1 AUC0-4 at Day 57|Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 57|Before drug administration to 4 hours after drug administration on Day 57|Full Analysis Set for Pulmonary Function Test Data||liters||Standard Error|Least Squares Mean
731882|NCT00400153|Secondary|FEV1 AUC0-4 at Day 29|Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 29|Before drug administration to 4 hours after drug administration on Day 29|Full Analysis Set for Pulmonary Function Test Data||liters||Standard Error|Least Squares Mean
731883|NCT00400153|Secondary|FEV1 AUC0-4 at Day 1|Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 1|Before drug administration to 4 hours after drug administration on Day 1|Full Analysis Set for Pulmonary Function Test Data||liters||Standard Error|Least Squares Mean
731884|NCT00400153|Secondary|FEV1 AUC0-6 at Day 57|Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 57|Before drug administration to 6 hours after drug administration on Day 57|Full Analysis Set for Pulmonary Function Test Data||liters||Standard Error|Least Squares Mean
731885|NCT00400153|Secondary|FEV1 AUC0-6 at Day 29|Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 29|Before drug administration to 6 hours after drug administration on Day 29|Full Analysis Set for Pulmonary Function Test Data||liters||Standard Error|Least Squares Mean
736585|NCT00443040|Secondary|Nausea Score||Daily for 38 days||||||
731886|NCT00400153|Secondary|FEV1 AUC0-6 at Day 1|Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 1|Before drug administration to 6 hours after drug administration on Day 1|Full Analysis Set for Pulmonary Function Test Data||liters||Standard Error|Least Squares Mean
731887|NCT00400153|Primary|FEV1 AUC4-6 at Day 85|Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 85|Between 4 hours and 6 hours after drug administration on Day 85|Full Analysis Set for Pulmonary Function Test Data 4-6 hours||liters||Standard Error|Least Squares Mean
731888|NCT00400153|Primary|FEV1 AUC0-4 at Day 85|Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 85|Before drug administration to 4 hours after drug administration on Day 85|Full Analysis Set for Pulmonary Function Test Data||liters||Standard Error|Least Squares Mean
731889|NCT00400153|Primary|FEV1 AUC0-6 at Day 85|Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 85|Before drug administration to 6 hours after drug administration on Day 85|Full Analysis Set for Pulmonary Function Test Data||liters||Standard Error|Least Squares Mean
731890|NCT00400179|Primary|Median Survival|Survival was defined as the time from the date of randomization to the time of death (from any cause) for each patient.|The cutoff date for survival analysis was 07 March 2008 (12 months after last patient randomized).|||Months||95% Confidence Interval|Median
731891|NCT00400179|Secondary|Time to Treatment Failure (TTF)|The time from randomization to date of permanent discontinuation of S-1 or 5-FU, first documented PD, or death, whichever occurred first.|From date of randomization until date of permanent discontinuation of S-1 or 5-FU, first documented PD, death, or data cutoff on 07 March 2008 (12 months after last patient randomized), whichever came first.|||Months||95% Confidence Interval|Median
731892|NCT00400179|Secondary|Progression-free Survival (PFS)|The time from randomization to date of first documented PD or date of death, whichever occurred first.|From date of randomization until date of first documented PD, date of death, or until data cutoff on 07 March 2008 (12 months after last patient randomized), whichever came first.|||Months||95% Confidence Interval|Median
731893|NCT00400179|Secondary|Duration of Response (DR)|Duration of response was defined as the time from date of first confirmed response (CR or PR) to date of first progressive disease (PD) or death. Per the RECIST criteria, definitions were as follows: CR was the disappearance of all target lesions for at least 4 weeks, PR was at least a 30% decrease in the sum of the longest diameter of target lesions, and PD was at least a 20% increase in the sum of the longest diameter of target lesions.|Data cutoff was 07 March 2008 (12 months after last patient was randomized).|||Months||95% Confidence Interval|Median
731894|NCT00400179|Secondary|Overall Response Rate (ORR)|The proportion of patients with objective evidence of complete response (CR) or partial response (PR) based on tumor response assessments. Per the Response Evaluation Criteria in Solid tumors (RECIST), CR was defined as the disappearance of all target lesions for at least 4 weeks, and PR was defined as at least a 30% decrease in the sum of the longest diameter of target lesions.|Data cutoff was 07 March 2008 (12 months after last patient randomized).|||Percentage of patients in each group||95% Confidence Interval|Number
731895|NCT00400205|Secondary|Measure the Acetylated Tubulin Expression and Correlate With Clinical Outcome.|IHC analysis of AT expression was performed in formalin-fixed, paraffin-embedded tissues. The staining was scored based upon intensity according to the following criteria: 0=no staining, 1+=weak tumor staining, 2+=moderate tumor staining, 3+=moderate to high tumor staining, and 4+=high tumor staining.|at baseline||||||
731896|NCT00400205|Primary|Number of Patients Who Had Response by RECIST Criteria (Response Evaluation Criteria in Solid Tumors)|Complete remission (complete disappearance of disease), partial remission [more than 30% decrease in tumor measurement by RECIST (Response evaluation criteria in solid tumors)].|every 3 months|||participants|||Number
731897|NCT00400400|Secondary|Change From Baseline (BL) to Day 30 in the Gastrointestinal Quality of Life Index (GIQLI) Total Score and Subscale Scores|The GIQLI is a 36-item questionnaire to assess the impact of GI disease on daily life. The GIQLI has 5 different subscales (GI symptoms, emotional status, physical and social functions, and stress of medical treatment) that are rated on a 5-point scale from 0 to 4. The individual scores are summed to produce a total score of the 36 items for a total possible score of 0 to 144. Lower scores represent greater dysfunction.|Baseline, Day 30|"Participants from the Intention-to-treat (ITT) population consisting of all randomized participants who received at least one dose of study drug for whom data was available for analysis. n in each of the categories is the number of participants with data available."||Score on a scale||Standard Deviation|Mean
731898|NCT00400400|Secondary|Change in Gastrointestinal Symptom Rating Scale Subscale Scores After 30 Days of Treatment|The GSRS has five subscales (reflux, diarrhea, constipation, abdominal pain, indigestion) producing a mean subscale score ranging from 1 (=no discomfort at all) to 7 (very severe discomfort). The mean score at baseline (BL), the mean score at Day 30 and the mean Change from BL to Day 30 is presented for each of the five subscales.|Baseline to Day 30|Intention-to-treat (ITT) population consisted of all randomized participants who received at least one dose of study drug. 2 participants in the enteric-coated mycophenolate sodium group were excluded from the analysis because they had no baseline data.||Score on a scale||Standard Deviation|Mean
731899|NCT00400400|Secondary|Change From Baseline in Lower and Upper GI Symptom Burden Measured by GI Symptom Rating Scale Score|This is reflected by the total score. The total score incorporates lower and upper GI elements. GSRS overall score is the mean of 15 individual GI symptom scores, each rated on a 7- point scale: 1 = no discomfort, 2= minor discomfort, 3 = mild discomfort, 4 = moderate discomfort, 5 = moderately sever discomfort, 6 = severe discomfort and 7 = very severe discomfort. Change from Baseline was calculated using ANCOVA, model includes GSRS, center and treatment group.|Baseline, Day 30|Intention-to-treat (ITT) population consisted of all randomized participants who received at least one dose of study drug. 2 participants in the enteric-coated mycophenolate sodium group were excluded from the analysis because they had no baseline data.||change in score on a scale||Standard Deviation|Mean
731914|NCT00406133|Post-Hoc|26-week A1c Level <7.0%, With no Severe Hypoglycemic Events for Cohort With Baseline HbA1c >=7.0%)|A post-hoc defined binary outcome of 26-week glycated hemoglobin <7.0% with no severe hypoglycemic events was analyzed in logistic regression models, adjusted for baseline glycated hemoglobin level and clinical center.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.||participants|||Number
731900|NCT00400400|Secondary|Number of Participants With Reported Dose Changes or Interruption of Study Medication During the 30 Days of Treatment|The number of participants with reported dose changes or interruption of study medication during the 30 days of treatment.The most common dose adjustments were dose increases back to baseline levels following a decrease or interruption and decreases due to abnormal laboratory value Adverse Events (leucopenia, thrombocytopenia, neutropenia, or anemia).|30 days|Intention to treat (ITT) population consisted of all randomized participants who received at least one dose of study drug.||Participants|||Number
731901|NCT00400400|Secondary|Change From Baseline to Day 30 in the Severity of Gastrointestinal Symptoms Overall Total Score|The Severity Score for each GI symptom for each participant was calculated based on the physician's evaluation of current GI symptoms recorded at Baseline and Day 30. For each of the 16 individual GI symptoms the severity score ranged from 0 (absent) to 3 (severe). The Overall Total Score is the Mean of severity ratings of the 16 individual symptoms.|Baseline, Day 30|"Intention to treat (ITT) population consisted of all randomized participants who received at least one dose of study drug. n in each of the categories is the number of participants with data."||Score on a scale||Standard Deviation|Mean
731902|NCT00400400|Secondary|Number of Participants With Biopsy-proven Acute Rejection (BPAR) and Treated Acute Rejection (TAR)|"TAR was defined as an episode of acute rejection that was suspected on clinical grounds and was treated and confirmed by the investigator according to the patient's response to therapy.
BPAR was defined a treated acute rejection that was confirmed by biopsy. A graft core biopsy was performed before or within 24 hours of initiation of anti-rejection therapy and was assessed by the pathologist at the center according to the BANFF 1997 criteria."|30 days|Intent-to-treat population consisted of all randomized participants who received at least one dose of study drug.||Participants|||Number
731903|NCT00400400|Primary|The Number of Participants Who Responded to the Conversion to Mycophenolate Sodium (EC-MPS) Therapy|Response assessed using the Gastrointestinal Symptom Rating Scale (GSRS), designed to assess common symptoms with gastrointestinal (GI) disorders. The GSRS has 5 subscales (reflux, diarrhea, constipation, abdominal pain and indigestion) producing a mean subscale score ranging from 1 (no discomfort) to 7 (very severe discomfort). The total score is an average of scores across all 15 items; a higher score indicates more GI symptoms. Response was defined as Day 30 improvement in the GSRS Total Score (change from baseline) of greater than or equal to 0.3. Minimum score is 1; maximum score is 7.|Baseline, Day 30|Intention-to-treat (ITT) population consisted of all randomized participants who received at least one dose of study drug. 2 participants in the enteric-coated mycophenolate sodium group were excluded from the analysis because they had no baseline data.||Participants|||Number
731904|NCT00406107|Secondary|Change in Macular Volume on OCT From Baseline to Week 54||54 Weeks|||mm cubed||Standard Deviation|Mean
731905|NCT00406107|Secondary|Change in Central Subfield Thickness on OCT From Baseline to Week 54||54 Weeks|||microns||Standard Deviation|Mean
731906|NCT00406107|Secondary|Safety Parameters|Safety endpoints incuded all investigator reported ocular and systemic adverse events. All events were graded as mild moderate or severe and assessed as related or unrelated to the injection procedure and the study drug.|54 Weeks|||percentage of participants|||Number
731907|NCT00406107|Secondary|Standardized Change From Baseline in Macular Thickening Measured by OCT3 Using the Central Point of the Central Subfield||54 Weeks|Fifteen patients were enrolled in the pegaptanib 0.3 mg dose group and 5 patients were enrolled in the 1.0 mg dose group.||microns||Standard Deviation|Mean
731908|NCT00406107|Primary|Change in ETDRS Best Corrected Visual Acuity From Baseline at 54 Weeks||54 Weeks|||ETDRS letters||Standard Deviation|Mean
731909|NCT00406133|Secondary|Total Costs: Direct and Indirect Costs|Investigators reported time spent with patients on CGM training and diabetes management excluding research time. Adult patients (or caregivers of children) self-reported health service utilization including routine office visits, after-hours clinic visits, emergency room visits, 911 calls, and hospitalizations. The daily cost of CGM technology was calculated based on FDA recommended frequency of sensor replacement and the expected frequency of receiver and transmitter replacement. The costs of the three devices used during the trial were averaged to arrive at a daily cost of CGM of $13.85. This daily cost was multiplied by the reported weekly use of CGM to arrive at an overall cost of CGM technology. Indirect costs: self-reported number of hours devoted to diabetes care per day, number of days missed from work or school due to diabetes, and number of days of work underperformance. Unit costs available at: http://care.diabetesjournals.org/cgi/content/full/dc09–2042/DC1 (Table 1).|26 weeks|Baseline A1c < 7.0%||dollars||Standard Error|Mean
731910|NCT00406133|Secondary|QALW|Quality Adjusted Life Weeks: We collected experienced utility data by eliciting time tradeoff (TTO) utilities for overall experience. Patients were asked to consider their current state of health in comparison to life in perfect health. Experienced utilities were elicited at baseline, 13 weeks, and 26 weeks. For children aged <18 years, parents served as surrogates. The total quality-adjusted life weeks (QALWs) were calculated as the area under the quality-of-life time trends under each arm.|26 weeks|Baseline A1c <7.0%||weeks||Standard Error|Mean
731911|NCT00406133|Other Pre-specified|26-week A1c Level <7.0% (for Cohort With Baseline HbA1c <7.0%)|Other preplanned secondary outcomes included change in HbA1c from baseline to 26 weeks in an ANCOVA model (adjusted for baseline HbA1c and clinical center) and 26-week binary HbA1c outcomes evaluated similarly in logistic regression models.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.||participants|||Number
731912|NCT00406133|Other Pre-specified|Increase in A1c From Baseline by >=0.3% (for Cohort With Baseline HbA1c <7.0%)|Other preplanned secondary outcomes included change in HbA1c from baseline to 26 weeks in an ANCOVA model (adjusted for baseline HbA1c and clinical center) and 26-week binary HbA1c outcomes evaluated similarly in logistic regression models.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.||participants|||Number
731913|NCT00406133|Other Pre-specified|Decrease in A1c From Baseline by >=0.3% (for Cohort With Baseline HbA1c <7.0%)|Other preplanned secondary outcomes included change in HbA1c from baseline to 26 weeks in an ANCOVA model (adjusted for baseline HbA1c and clinical center) and 26-week binary HbA1c outcomes evaluated similarly in logistic regression models.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.||participants|||Number
732430|NCT00403403|Primary|Progression-free Survival (PFS)|Duration of PFS, defined as the time from randomization to disease progression or on-study death, whichever occurred first.|Randomization until progression or lost to follow-up (up to 2 years)|Intent-to-treat population||Months||95% Confidence Interval|Median
731915|NCT00406133|Other Pre-specified|26-week A1c Level <7.0% (for Cohort With Baseline HbA1c >=7.0%)|A 26-week A1c level <7.0% was evaluated in logistic-regression models, adjusted for the baseline glycated hemoglobin level and clinical center.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.||participants|||Number
731916|NCT00406133|Other Pre-specified|Relative Increase in A1c Level by >=0.5% (for Cohort With Baseline HbA1c >=7.0%)|A relative increase by in A1c level >=0.5% was evaluated in logistic-regression models, adjusted for the baseline glycated hemoglobin level and clinical center.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.||participants|||Number
731917|NCT00406133|Other Pre-specified|Relative Decrease in A1c Level by >=0.5% (for Cohort With Baseline HbA1c >=7.0%)|A relative decrease A1c level by >=0.5% was evaluated in logistic-regression models, adjusted for the baseline glycated hemoglobin level and clinical center.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.||participants|||Number
731918|NCT00406133|Secondary|Cost-effectiveness of CGM.|Estimated total costs divided by estimated Quality-Adjusted Life Weeks (QALW) calculated per group|26 weeks|Baseline A1c<7%.||dollars per QALY|||Number
731919|NCT00406133|Secondary|Quality of Life|Hypoglycemia Fear Survey Total Score Average score of all items giving equal weight to each item. Scale 0-100 with higher score denoting more fear or more likely to avoid low blood glucose.|26 weeks|Participants >= 18 years of age. Pools participants with baseline HbA1c <7.0% and >=7.0%.||units on a scale||Standard Deviation|Mean
731920|NCT00406133|Secondary|Absolute Rate of Change (mg/dl/Min) at 26 Weeks (for Cohort With Baseline HbA1c <7.0%)|Glucose variability was assessed by computing the absolute rate of change.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.||mg/dl/min||Inter-Quartile Range|Median
731921|NCT00406133|Secondary|Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=50 mg/dL (for Cohort With Baseline HbA1c <7.0%)|Data regarding continuous glucose monitoring in both groups after the 26-week visit were used to estimate the amount of time per day the glucose level was hypoglycemic (<=50 mg/dL)|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.||minutes/day||Inter-Quartile Range|Median
731922|NCT00406133|Secondary|Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >250 mg/dL (for the Cohort With Baseline HbA1c <7.0% Cohort|Data regarding continuous glucose monitoring were obtained after completion of the 26-week visit with the use of an unblinded device in the RT-CGM group and a blinded device in the Control group. Measure consists of minutes/day in range.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.||minutes/day||Inter-Quartile Range|Median
731923|NCT00406133|Other Pre-specified|Relative Increase in A1c Level by >=10% (for Cohort With Baseline HbA1c >=7.0%)|A relative increase in A1c level by >=10% was evaluated in logistic-regression models, adjusted for the baseline glycated hemoglobin level and clinical center.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.||participants|||Number
731924|NCT00406133|Other Pre-specified|Relative Decrease in A1c Level by >=10% (for Cohort With Baseline HbA1c >=7.0%)|A relative decrease in A1c level >=10% was evaluated in logistic-regression models, adjusted for the baseline glycated hemoglobin level and clinical center.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.||participants|||Number
731925|NCT00406133|Secondary|Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >180 mg/dL (for Cohort With Baseline HbA1c <7.0%)|Data regarding CGM were obtained after completion of the 26-week visit with the use of an unblinded device in the RT-CGM group and a blinded device in the Control group. Measure consists of minutes/day in range.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.||minutes/day||Inter-Quartile Range|Median
731926|NCT00406133|Secondary|Minutes Per Day of Continuous Glucose Monitoring (CGM) Glucose Values 71-180 mg/dL (for Cohort With Baseline HbA1c <7.0%)|Data regarding CGM were obtained after completion of the 26-week visit with the use of an unblinded device in the RT-CGM group and a blinded device in the Control group. Measure consists of minutes/day in range.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.||minutes/day||Inter-Quartile Range|Median
731927|NCT00406133|Secondary|Change in Glycated Hemoglobin (HbA1c) From Baseline to 26 Weeks in the Continuous Glucose Monitoring (CGM) and Control Groups (for the Cohort With Baseline HbA1c <7.0% Cohort)|The secondary outcome was the change in glycated hemoglobin (HbA1c) from baseline to 26 weeks in the Continuous Glucose Monitoring (CGM) and Control groups (for the cohort with baseline HbA1c <7.0% cohort), as determined by a central laboratory.|Baseline and 26 weeks|Analysis was performed according to Intention to Treat principle. Results based on non-missing data were reported. Imputation for missing data using Rubin's method did not alter the results (data not shown).||Percent||Standard Deviation|Mean
731928|NCT00406133|Secondary|Glucose (mg/dl) at Baseline and 26 Weeks (for Cohort With Baseline HbA1c >=7.0%)|Glucose variability was assessed by computing the absolute rate of change.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.||Mean mg/dl/minute||Standard Deviation|Mean
731929|NCT00406133|Secondary|Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=50 mg/dL (for Cohort With Baseline HbA1c >=7.0%)|Data regarding continuous glucose monitoring in both groups after the 26-week visit were used to estimate the amount of time per day the glucose level was hypoglycemic (<=50 mg/dL)|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.||minutes/day||Standard Deviation|Mean
731930|NCT00406133|Secondary|Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=70 mg/dL (for Cohort With Baseline HbA1c >=7.0%)|Data regarding continuous glucose monitoring in both groups after the 26-week visit were used to estimate the amount of time per day the glucose level was hypoglycemic (<=70 mg/dL)|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.||minutes/day||Standard Deviation|Mean
731931|NCT00406133|Secondary|Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >250 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort|Data regarding continuous glucose monitoring were obtained after completion of the 26-week visit with the use of an unblinded device in the RT-CGM group and a blinded device in the Control group. Measure consists of minutes/day in range.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.||minutes/day||Standard Deviation|Mean
732431|NCT00403455|Secondary|(Short Form -36 Health Care Quality of Life Scale).||12 weeks||||||
732432|NCT00403455|Secondary|DTS||12 weeks||||||
731932|NCT00406133|Secondary|Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >180 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort)|Data regarding CGM were obtained after completion of the 26-week visit with the use of an unblinded device in the RT-CGM group and a blinded device in the Control group. Measure consists of minutes/day in range.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.||minutes/day||Standard Deviation|Mean
731933|NCT00406133|Secondary|Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values 71-180 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort)|Data regarding CGM were obtained after completion of the 26-week visit with the use of an unblinded device in the RT-CGM group and a blinded device in the Control group. Measure consists of minutes/day in range.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.||minutes/day||Standard Deviation|Mean
731934|NCT00406133|Secondary|Severe Hypoglycemia (for the Cohort With Baseline HbA1c >=7.0% Cohort)|Measure of the number of severe hypoglycemic events in the cohort with baseline HbA1c >=7.0% cohort|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.||subjects with event|||Number
731935|NCT00406133|Primary|Time With Glucose Level <=70 mg/dL (for the Cohort With Baseline HbA1c <7.0%)|The primary outcome was the change in the time per day with glucose values <=70mg/dL comparing baseline sensor values with those obtained following the 26-week visit.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.||minutes/day||Inter-Quartile Range|Median
731936|NCT00406133|Primary|Change in Glycated Hemoglobin (HbA1c) From Baseline to 26 Weeks in the Continuous Glucose Monitoring (CGM) and Control Groups (for the Cohort With Baseline HbA1c >=7.0% Cohort)|The primary outcome was the Change in glycated hemoglobin (HbA1c) from baseline to 26 weeks, as determined by a central laboratory (for the cohort with baseline HbA1c >=7.0% cohort).|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.||Percent||Standard Deviation|Mean
731937|NCT00406276|Primary|Time to Progression:Time Period (in Months) From Study Entry Until Disease Progression, Death, or Last Date of Contact.|"Period from study entry until disease progression, death, or last date of contact.
Progressive Disease: Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions."|6 months|||Months||Full Range|Median
731938|NCT00406276|Primary|Number of Subjects Showing Partial Response and Stable Disease With the Combination of RAD001 and Docetaxel.|"Partial response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of LD.
Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive disease (PD), taking as reference the smallest sum Longest diameter(LD) since treatment started."|6 weeks|24 patients received at least 2 cycles of therapy and underwent imaging studies to assess response.||participants|||Number
731939|NCT00406315|Secondary|Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TQSM) Effectiveness, Side Effect, Convenience, and Global Satisfaction Subscales at Week 16|The TSQM is a 13-item subject-rated scale that evaluates the effectiveness, side effects and convenience of the medication over the past 2-3 weeks. Likert scale: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 0 and best value is 100. TSQM Effectivenss, Side Effect, Convenience, and Global Satisfaction scores: Change: score at Week 16 or Week 16 LOCF minus score at Baseline.|Baseline, Week 16, Week 16 LOCF|ITT. LOCF was used to impute missing values. The LOCF value was the last non-missing, post-baseline observation carried forward for each subject.||scores on a scale||Standard Deviation|Mean
731940|NCT00406315|Secondary|Change From Baseline in Global Assessment of Function Scale (GAF) Score at Week 16|GAF Scale measures the severity of illness-related impairment in psychological, social, and occupational functioning using a 100-point scale. Total possible score ranges from 0 (not enough information available to provide GAF) to 100 (Superior functioning in a wide range of activities, life's problems never seem to get out of hand, is sought out by others because of his or her many qualities. No symptoms). The assessment was done by a trained assessor. GAF scale score: Change: score at Week 16 or Week 16 LOCF minus score at Baseline.|Baseline, Week 16, Week 16 LOCF|ITT. LOCF was used to impute missing values. LOCF value was the last non-missing, post-baseline observation carried forward for each subject.||scores on a scale||Standard Deviation|Mean
731941|NCT00406315|Secondary|Change From Baseline in Schizophrenia Cognition Rating Scale (SCoRS) Total Score and Global Rating at Week 16|The SCoRS is a 20-question rating scale completed via interviews with the subject and an informant, focusing on cognitive impairment and its impact on daily functioning. Each question was completed using a 4-point scale (ranging from 1=none to 4=severe). Total possible score ranged from 20 to 80. At the end of the 20 questions, the interviewer completed a Global Scale of 1-10, rating subject's overall difficulty. Higher scores on both indicated greater cognitive impairment. SCoRS total score and global rating: Change: score at Week 16 or Week 16 LOCF minus score at Baseline.|Baseline, Week 16, Week 16 LOCF|ITT. LOCF was used to impute missing values. The LOCF value was the last non-missing, post-baseline observation carried forward for each subject.||scores on a scale||Standard Deviation|Mean
731942|NCT00406315|Secondary|Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Week 16|The CDSS is a 9-item, clinician-rated scale validated for rating the severity of depressive symptoms in subjects diagnosed with schizophrenia, and independent of confounding negative and extrapyramidal symptoms. The CDSS rates the severity of depressive symptoms on a 4-point scale ranging from 0 (absent) to 3 (severe). The CDSS depression total score is obtained by adding each of the item scores. Total possible score ranges from 0 to 27. CDSS possible total score: Change: score at Week 16 or Week 16 LOCF minus score at Baseline.|Baseline, Week 16, Week 16 LOCF|ITT. LOCF was used to impute missing values. The LOCF value was the last non-missing, post-baseline observation carried forward for each subject.||scores on a scale||Standard Deviation|Mean
731943|NCT00406315|Secondary|Observed Cases of Clinical Global Impression Improvement Scale (CGI-I) Scores at Week 16|The CGI-I is a 7-point, single-item, clinician-rated scale that assesses global improvement in the subject’s clinical state in response to study treatment, and as compared to their status at pre-treatment baseline. Possible CGI-I scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse).|Week 16, Week 16 LOCF|ITT. LOCF was used to impute missing values. The LOCF value was the last non-missing, post-baseline observation carried forward for each subject.||scores on a scale||Standard Deviation|Mean
732433|NCT00403455|Secondary|Q-LES-Q||12 weeks||||||
732434|NCT00403455|Secondary|Ham-D||12 weeks||||||
731944|NCT00406315|Secondary|Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) at Week 16|The CGI-S is a single item, clinician-rated scale that assesses the global severity of the subject’s overall illness. The CGI-S ratings range from 1 (normal, not at all ill) to 7 (among the most severely ill subjects). CGI-S score: Change: score at Week 16 or Week 16 LOCF minus score at Baseline.|Baseline, Week 16, Week 16 LOCF|ITT. LOCF was used to impute missing values. The LOCF value was the last non-missing, post-baseline observation carried forward for each subject.||scores on a scale||Standard Deviation|Mean
731945|NCT00406315|Secondary|Change From Baseline in Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score, and Positive and Negative Subscale Scores at Week 16|PANSS measures severity of psychopathology in subjects with schizophrenia, schizoaffective disorder and other psychotic disorders. It includes 3 scales and a total of 30 items: 7 items comprise the positive scale, 7 comprise the negative scale, and 16 items measure general psychopathology. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210. PANSS total score and positive and negative scores: Change = score at Week 16 or Week 16 LOCF minus score at Baseline.|Baseline, Week 16, Week 16 LOCF|Intent-to-treat population (ITT) = all enrolled subjects with baseline and at least 1 post baseline efficacy evaluation. LOCF was used to impute missing values. LOCF value was the last non-missing, post-baseline observation carried forward for each subject.||scores on a scale||Standard Deviation|Mean
731946|NCT00406315|Secondary|Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score, Global Severity Score, and Global Incapacitation Score at Week 16|AIMS: a 12-item clinician administered instrument assessing observed abnormal movements in different parts of body. Ten items scored on a 5-point scale (0 = none/normal, 4 = severe) evaluate abnormal movements in three main anatomic areas (orofacial area, extremities, and trunk). Two items are yes/no questions regarding dentures. Total scores range from 0 to 42. Item 8 indicates severity, item 9 indicates Incapacitation. AIMS total, global severity, or global incapacitation score: Change = score at Week 16 minus score at Baseline.|Baseline, Week 16|Safety population.||scores on a scale||Standard Deviation|Mean
731947|NCT00406315|Secondary|Change From Baseline in Waist and Hip Circumference at Week 16|Waist and hip circumference value: Change = value at Week 16 minus value at Baseline.|Baseline, Week 16|Safety population.||centimeter||Standard Deviation|Mean
731948|NCT00406315|Secondary|Change From Baseline in Fasting Insulin at Week 16|Fasting insulin value: Change = value at Week 16 minus value at Baseline.|Baseline, Week 16|Safety population.||microinternational (mciu)/milliliter(mL)||Standard Deviation|Mean
731949|NCT00406315|Secondary|Change From Baseline in Fasting Glucose at Week 16|Fasting glucose value: Change = value at Week 16 minus value at Baseline.|Baseline, Week 16|Safety population.||mg/dL||Standard Deviation|Mean
731950|NCT00406315|Secondary|Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 16|HbAlc value: Change = value at Week 16 minus value at Baseline.|Baseline, Week 16|Safety population.||percent||Standard Deviation|Mean
731951|NCT00406315|Secondary|Change From Baseline in High-Density Lipoprotein (HDL), Low-Density Lipoprotein (LDL), and Triglycerides at Week 16|HDL, LDL, and triglyceride value: Change = value at Week 16 minus value at Baseline.|Baseline, Week 16|Safety population.||mg/dL||Standard Deviation|Mean
731952|NCT00406315|Secondary|Change From Baseline in Fasting Lipid Profile (Total Cholesterol) at Week 16|Total cholesterol value: Change = value at Week 16 minus value at Baseline.|Baseline, Week 16|Safety population.||milligram (mg)/deciliter (dL)||Standard Deviation|Mean
731953|NCT00406315|Primary|Change From Baseline in Weight at Week 16|Weight value: Change = value at Week 16 or Week 16 Last Observation Carried Forward (LOCF) minus value at Baseline.|Baseline, Week 16, Week 16 LOCF|Safety population = all enrolled subjects who took at least 1 dose of study medication. LOCF was used to impute missing values. LOCF value was the last non-missing, post-baseline observation carried forward for each subject.||kilogram||Standard Deviation|Mean
731954|NCT00406354|Secondary|Number of Patients Who Experienced Clinically Relevant Categories of Adverse Events During Nine-Week Study Treatment Period|Number of participants who experienced pre-specified categories of clinically relevant adverse events during the nine-week study treatment period. NOTE: this is a subset of the overall adverse events which are reported by participant and event.|9 weeks|All randomized participants who received at least one dose of study drug.||participants|||Number
731955|NCT00406354|Secondary|Number of Patients Who Experienced Clinically Relevant Categories of Adverse Events During Initial Three Weeks of Study Treatment|Number of participants who experienced pre-specified categories of clinically relevant adverse events during the initial three-weeks of study treatment. NOTE: this is a subset of the overall adverse events which are reported by participant and event.|3 weeks|All randomized participants who received at least one dose of study drug.||participants|||Number
731956|NCT00406354|Secondary|Number of Participants Discontinuing Treatment|Originally, time to treatment discontinuation was analyzed, deeming participants 'censored' if they reached the end of the observation period, were lost to followup, or withdrew informed consent. Because the median was not reached, the number of participants who discontinued (i.e., those who were not censored) is reported here.|9 weeks|All participants randomized and receiving at least one dose of study drug.||participants|||Number
731957|NCT00406354|Secondary|German Revised Children's Quality of Life Questionnaire (KINDL-R): School Score|"KINDL-R (Revidierter KINDer Lebensqualitatsfragebogen, revised version), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL. It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness. Each item is rated on a 5-point scale (1= never; 5= all the time). The lowest possible score on the School subscore is 0; the highest possible score is 100. Scores were normalized between 0 and 100, irrespective of the number of items per subscore. Higher scores indicate better QOL."|9 weeks|All participants randomized and receiving at least one dose of study drug.||units on a scale||Standard Error|Least Squares Mean
731968|NCT00406354|Secondary|Investigator-Rated Individual Target Behaviors (ITB-Inv): Frequency Score|ITB-Inv assesses frequency and intensity of individually-defined target behaviors. The investigator defines 3 individual behavior problems based on interviews and additional information. Those most impairing for the child or stressful for the parents will be chosen as target behavior. Frequency of each target behavior during the last 7 days is rated on a 6-point scale (0=never to 5=always) with 0 as lowest possible score and 15 the highest possible score.|9 weeks|All participants randomized and receiving at least one dose of study drug.||units on a scale||Standard Error|Least Squares Mean
731958|NCT00406354|Secondary|German Revised Children's Quality of Life Questionnaire (KINDL-R): Friends Score|"KINDL-R (Revidierter KINDer Lebensqualitatsfragebogen, revised version), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL. It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness. Each item is rated on a 5-point scale (1= never; 5= all the time). The lowest possible score on the Friends subscale is 0; the highest possible score is 100. Scores were normalized between 0 and 100, irrespective of the number of items per subscore. Higher scores indicate better QOL."|9 weeks|All participants randomized and receiving at least one dose of study drug.||units on a scale||Standard Error|Least Squares Mean
731959|NCT00406354|Secondary|German Revised Children's Quality of Life Questionnaire (KINDL-R): Family Score|"KINDL-R (Revidierter KINDer Lebensqualitatsfragebogen, revised version), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL. It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness. Each item is rated on a 5-point scale (1=never; 5=all the time). The lowest possible score on the Family subscale is 0; the highest possible score is 100. Scores were normalized between 0 and 100, irrespective of the number of items per subscore. Higher scores indicate better QOL."|9 weeks|All participants randomized and receiving at least one dose of study drug.||units on a scale||Standard Error|Least Squares Mean
731960|NCT00406354|Secondary|German Revised Children's Quality of Life Questionnaire (KINDL-R): Self Esteem Score|"KINDL-R (Revidierter KINDer Lebensqualitatsfragebogen, revised version), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL. It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness. Each item is rated on a 5-point scale (1= never; 5= all the time). The lowest possible score on the Self Esteem subscale is 0; the highest possible score is 100. Scores were normalized between 0 and 100, irrespective of the number of items per subscore. Higher scores indicate better QOL."|9 weeks|All participants randomized and receiving at least one dose of study drug.||units on a scale||Standard Error|Least Squares Mean
731961|NCT00406354|Secondary|German Revised Children's Quality of Life Questionnaire (KINDL-R): Emotional Well-Being Score|"KINDL-R (Revidierter KINDer Lebensqualitatsfragebogen, revised version), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL. It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness. Each item is rated on a 5-point scale (1= never; 5= all the time).The lowest possible score for the Emotional Well-Being subscale is 0; highest possible score is 100. Scores were normalized between 0 and 100, irrespective of the number of items per subscore. Higher scores indicate better QOL."|9 weeks|All participants randomized and receiving at least one dose of study drug.||units on a scale||Standard Error|Least Squares Mean
731962|NCT00406354|Secondary|German Revised Children's Quality of Life Questionnaire (KINDL-R): Physical Well-Being Score|"KINDL-R (Revidierter KINDer Lebensqualitatsfragebogen, revised version), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL. It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness. Each item is rated on a 5-point scale (1= never; 5= all the time). The lowest possible score on the Physical Well-Being subscale is 0; highest possible score is 100. Scores were normalized between 0 and 100, irrespective of the number of items per subscore. Higher scores indicate better QOL."|9 weeks|All participants randomized and receiving at least one dose of study drug.||units on a scale||Standard Error|Least Squares Mean
731963|NCT00406354|Secondary|German Revised Children's Quality of Life Questionnaire (KINDL-R): Total Quality of Life Score|"KINDL-R (Revidierter KINDer Lebensqualitatsfragebogen, revised version), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL. It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness. Each item is rated on a 5-point scale (1= never; 5= all the time). The lowest possible score in the Total QOL score is 0; the highest possible score is 100. Scores were normalized between 0 and 100, irrespective of the number of items per subscore. Higher score indicates better QOL."|9 weeks|All participants randomized and receiving at least one dose of study drug.||units on a scale||Standard Error|Least Squares Mean
731964|NCT00406354|Secondary|Clinical Global Impressions - Severity (CGI-S): Combined ADHD and ODD Scores|The physician-rated CGI-S Combined ADHD and ODD measures the participant's overall severity of both ADHD and ODD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients) during the last 7 days.|9 weeks|All participants randomized and receiving at least one dose of study drug.||units on a scale||Standard Error|Least Squares Mean
731965|NCT00406354|Secondary|Clinical Global Impressions - Severity (CGI-S): ODD Score|The physician-rated CGI-S ODD measures the participant's overall severity of ODD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients) during the last 7 days.|9 weeks|All participants randomized and receiving at least one dose of study drug.||units on a scale||Standard Error|Least Squares Mean
731966|NCT00406354|Secondary|Clinical Global Impressions - Severity (CGI-S): ADHD Score|The physician-rated CGI-S ADHD measures the participant's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients) during the last 7 days.|9 weeks|All participants randomized and receiving at least one dose of study drug.||units on a scale||Standard Error|Least Squares Mean
731967|NCT00406354|Secondary|Impact on Family Scale (FaBel), Total Impact Score|Family burden is assessed by the FaBel questionnaire (German version of the Impact on Family Scale). Questionnaire is answered by participant's caregiver and contains 33 Likert-scaled items to assess general negative impact (of a disability, disorder, disease) on parents, description of social relationships, concern for siblings, financial impact, problems in coping as well as a total score. Each item is rated on a 4-point scale (1=fully applies, 4=applies not at all). Total scores range from 24-96. Higher scores correspond to higher family burden.|9 weeks|All participants randomized and receiving at least one dose of study drug.||units on a scale||Standard Error|Least Squares Mean
731980|NCT00406393|Secondary|Time to Discharge After Transplant||Measured at Year 2|Insufficient data to report on this outcome measure|||||
731981|NCT00406393|Secondary|Infections||Measured at Year 2|Insufficient data to report on this outcome measure|||||
731982|NCT00406393|Secondary|Overall Survival||Measured at Year 2|||percentage of participants||95% Confidence Interval|Number
732435|NCT00403455|Secondary|CGI-I||12 weeks||||||
732436|NCT00403455|Secondary|CGI-S||12 weeks||||||
731969|NCT00406354|Secondary|Investigator-Rated Individual Target Behaviors (ITB-Inv): Intensity Score|ITB-Inv assesses frequency and intensity of individually-defined target behaviors. The investigator defines 3 individual behavior problems based on interviews and additional information. Those most impairing for the child or stressful for the parents will be chosen as target behavior. Intensity during the last 7 days is rated on a 10-point scale (0=no problems to 9=most severe problems) with the lowest possible score of 0 and the highest possible of 27.|9 weeks|All participants randomized and receiving at least one dose of study drug.||units on a scale||Standard Error|Least Squares Mean
731970|NCT00406354|Secondary|Parent-Rated Oppositional Defiant/Conduct Disorders Scale (FBB-SSV): Total Score, Severity|"FBB-SSV (Fremdbeurteilungsbogen fur Storungen des Sozialverhaltens), the German, parent-rated oppositional defiant/conduct disorders scale, covers 23 criteria for ODD and 25 for conduct disorder (CD) in four sections. Parents rated symptom severity of each item during the last 7 days on a 0 to 3 scale (0=not at all to 3=very much). The total score was calculated for ODD/CD overall (sum of ratings for items 1-17, divided by 17). Higher scores indicate higher severity of symptoms."|9 weeks|All participants randomized and receiving at least one dose of study drug.||units on a scale||Standard Error|Least Squares Mean
731971|NCT00406354|Secondary|Parent-Rated Attention-Deficit Scale (FBB-HKS), Total Score: Severity|"FBB-HKS (Fremdbeurteilungsbogen fur Hyperkinetische Storungen), the German, parent-rated scale for attention-deficit, is a 20-item rating scale which describes ADHD symptom criteria of DSM-IV and is grouped based upon the 3 ADHD domains: inattention (items 1-9); hyperactivity (items 10-16); impulsivity (items 17-20). Parents rated symptom severity of each item during the last 7 days on a 0 to 3 scale (0=not at all to 3=very much). The total score was calculated for ADHD overall (sum of ratings for items 1-20, divided by 20). Higher scores indicate higher severity of symptoms."|9 weeks|All participants randomized and receiving at least one dose of study drug.||units on a scale||Standard Error|Least Squares Mean
731972|NCT00406354|Secondary|Swanson, Nolan & Pelham Rating Scale - Revised (SNAP-IV): Hyperactivity/Impulsivity Score|The SNAP-IV: ADHD Hyperactivity/Impulsivity Subscale (items 10-18) scores the intensity of each item during the last seven days on a 0 to 3 scale (0=not at all, 1=just a little, 2=pretty much, 3=very much). The lowest possible score is 0; highest is 27.|9 weeks|All participants randomized and receiving at least one dose of study drug.||units on a scale||Standard Error|Least Squares Mean
731973|NCT00406354|Secondary|Swanson, Nolan & Pelham Rating Scale - Revised (SNAP-IV): ADHD Inattention Score|The SNAP-IV: ADHD Inattention Subscale (items 1-9) scores the intensity of each item during the last seven days on a 0 to 3 scale (0=not at all, 1=just a little, 2=pretty much, 3=very much). The lowest possible score is 0; highest is 27.|9 weeks|All participants randomized and receiving at least one dose of study drug.||units on a scale||Standard Error|Least Squares Mean
731974|NCT00406354|Secondary|Swanson, Nolan & Pelham Rating Scale - Revised (SNAP-IV): ADHD Combined Score|The SNAP-IV: ADHD Combined Subscale for inattention (items 1-9) and hyperactivity/impulsivity (items 11-19) scores the intensity of each item during the last seven days on a 0 to 3 scale (0=not at all, 1=just a little, 2=pretty much, 3=very much). The lowest possible score is 0; highest is 54.|9 weeks|All participants randomized and receiving at least one dose of study drug.||units on a scale||Standard Error|Least Squares Mean
731975|NCT00406354|Primary|Swanson, Nolan and Pelham Rating Scale Revised (SNAP-IV) Oppositional Defiant Disorder: (ODD) Score|The SNAP-IV, a 26-item scale, includes 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD and 1 item for each of the 8 symptoms contained in the DSM-IV diagnosis of ODD. Each item is scored on a 0 to 3 scale (0=Not at All, 1=Just a Little, 2=Pretty Much, 3=Very Much). The SNAP-IV yields scores in three domains: Inattention (items 1-9: subscore range=0-27), Hyperact-ivity/Impulsivity (items 10-18: subscale range=0-27), and Oppositional (items 19-26: subscale range=0-24). SNAP-IV: ADHD Combined Scale score (inattention + hyperactivity/impulsivity) ranges from 0-54.|9 weeks|All participants randomized and receiving at least one dose of study drug.||units on a scale||Standard Error|Least Squares Mean
731976|NCT00406367|Secondary|Patient Evaluation of Global Response (PEGR) at Final Visit|"The PEGR is a descriptive subjective 9-point response scale ranging from complete abolishment of signs and symptoms (value=+4) down to very marked worsening (value=-4)."|Final visit (up to week 20 after injection of the Main Period)|"Intention to treat population with missing values imputed by no effect."||Points on a scale||Standard Deviation|Mean
731977|NCT00406367|Secondary|Blepharospasm Disability Index (BSDI) Change From Baseline in the BSDI at Week 6 After Injection|The Blepharospasm Disability Index is a scale for the assessment of impairment of specific activities of daily living caused by blepharospasm. The BSDI consists of six items (driving a vehicle; reading; watching TV; shopping; getting about on foot (walking); doing everyday activities), each ranges from 0 (=no impairment) to 4 (=no longer possible due to illness). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.|Baseline, week 6|Intention to treat population by using the Last Observation Carried Forward (LOCF) imputation technique for missing values||Points on a scale||Standard Deviation|Mean
731978|NCT00406367|Secondary|Jankovic Rating Scale (JRS) Change From Baseline in the JRS Severity Subscore at Week 6 After Injection (Assessed by Subject Diary)|"The Jankovic Rating Scale (JRS) is used for classification of the patient's individual symptoms of blepharospasm and for determination of the therapeutic efficacy of study medication. The JRS sumscore is the sum of the two components of the scale:
JRS-Severity score which ranges from 0 (=absence of severity) to 4 (=maximum severity)
JRS-Frequency score which ranges from 0 (=no frequency) to 4 (=maximum frequency) The change from baseline was calculated as the score at the corresponding visit minus the baseline score."|Baseline, week 6|Intention to treat population by using the Last Observation Carried Forward (LOCF) imputation technique for missing values||Points on a scale||Standard Deviation|Mean
731979|NCT00406367|Primary|Jankovic Rating Scale (JRS) Change From Baseline in the JRS Severity Subscore at Week 6 After Injection (Assessed by a Blinded Independent Rater)|"The Jankovic Rating Scale (JRS) is used for classification of the patient's individual symptoms of blepharospasm and for determination of the therapeutic efficacy of study medication. The JRS sumscore is the sum of the two components of the scale:
JRS-Severity score which ranges from 0 (=absence of severity) to 4 (=maximum severity)
JRS-Frequency score which ranges from 0 (=no frequency) to 4 (=maximum frequency) The change from baseline was calculated as the score at the corresponding visit minus the baseline score."|Baseline, week 6|Intention to treat population: all participants randomized were included in the primary efficacy analysis; Last Observation Carried Forward (LOCF) imputation technique used for missing values||Points on a scale||Standard Error|Least Squares Mean
731983|NCT00406393|Secondary|Malignant Disease Relapse|Testing for recurrent malignancy in the blood, marrow or other sites will be used to assess relapse after transplantation. For the purpose of this study, relapse is defined by either morphological or cytogenetic evidence of AML, ALL, CML, MDS or CMML consistent with pre-transplant features.|Measured at Year 2|||percentage of participants||95% Confidence Interval|Number
731984|NCT00406393|Secondary|Treatment-related Mortality||Measured at Day 100 and Year 2|||percentage of participants||95% Confidence Interval|Number
731985|NCT00406393|Secondary|Reactivation of Cytomegalovirus (CMV) Infection||Measured at Year 2|||percentage of participants||95% Confidence Interval|Number
731986|NCT00406393|Secondary|Thrombotic Microangiopathy (TMA) Infection|The occurrence of TMA within the first 100 days after stem cell transplantation will be recorded. The first day of onset will be used for reporting purposes.|Measured through Day 100|||percentage of participants||95% Confidence Interval|Number
731987|NCT00406393|Secondary|Rate of Veno-occlusive Disease (VOD)|VOD will be defined as the occurrence of VOD (based on the Baltimore Criteria for the diagnosis of VOD) in conjunction with other end-organ dysfunction.|Measured through Day 100|||percentage of participants||95% Confidence Interval|Number
731988|NCT00406393|Secondary|Mucositis Severity|Mucositis severity will be scored per the modified Oral Mucositis Assessment Scale (OMAS) scoring system on a scale of 0 - 4, where 0 equals normal mucosa and 4 represents severe mucosa.|Measured at Day 21|||units on a scale||Standard Deviation|Mean
731989|NCT00406393|Secondary|Time to Neutrophil and Platelet Engraftment|Neutrophil engraftment is defined as achieving an Absolute Neutrophil Count (ANC) > 500/mcL for three consecutive measurements on different days. Platelet engraftment is defined as a platelet count > 20,000/mcL for three consecutive measurements over three or more days.|Measured through Day 100|||days||Full Range|Median
731990|NCT00406393|Secondary|Incidence of Acute GVHD|Cumulative incidence of acute GVHD (grade II-IV) occurring 100 days from transplantation.|Measured at Day 100|||percentage of participants||95% Confidence Interval|Number
731991|NCT00406393|Primary|Rate of Grades II-IV Acute GVHD-free Survival|The primary objective is to compare rates of 114-day Grades II-IV acute GVHD-free survival post randomization for HLA-matched, related donor allogeneic peripheral blood stem cell transplantation using two different GVHD prophylaxis regimens. Participants are graded on a scale of 1 to 4 according to their symptoms and organs involved, where 4 represents a worse grade.|Day 114|||percentage of participants||95% Confidence Interval|Number
731992|NCT00407797|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale (HADS)|Participant rated questionnaire with 2 subscales: HADS-A assesses generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D: state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale has 7 items; range: 0 (no anxiety or depression) to 3 (severe anxiety or depression). Total score 0 to 21 for each subscale; higher score = greater severity of symptoms. Negative value = reduction from baseline (b), positive value = increase from b. Change = (HADS score at observation period minus HADS score at b) divided by HADS score b.|Week 21, LOCF|FAS. LOCF = Last Observation Carried Forward.||scores on scale||Standard Deviation|Mean
731993|NCT00407797|Secondary|Change From Baseline in Sleep Interference: Medical Outcome Sleep Scale (MOS): Optimal Sleep Subscale|Optimal Sleep subscale of the MOS subject rated questionnaire to assess sleep quality and quantity. Optimal Sleep (1 of 7 subscales) was derived from sleep quantity: average hours of sleep each night during the past week. Number of subjects with response: YES=1 (optimal sleep: quantity of sleep was 7 or 8 hours per night) or No= 0 (no optimal sleep). Negative value indicates a decrease in attribute; positive value indicates an increase in attribute. Change = (MOS score at observation period minus MOS score at baseline [b]) divided by MOS score b.|Week 21, LOCF|FAS. LOCF=Last Observation Carried Forward.||scores on scale||Standard Deviation|Mean
731994|NCT00407797|Secondary|Change From Baseline in Sleep Interference: Medical Outcome Sleep Scale (MOS)|Participant rated questionnaire to assess sleep quality and quantity; 9-item overall sleep problems index and 7 subscales. Sleep disturbance, snoring, awaken short of breath, somnolence, and adequacy subscale scores (s) rated 1 (all the time) to 6 (none of the time); transformed s; total range (r): 0 to 100; higher s = greater intensity of attribute; negative values (v) = reduction from baseline (b), positive v = increase from b. Sleep Quantity score r: 0-24 hours. Higher s = greater quantity of sleep. Change = (MOS score at observation period minus MOS score at b) divided by MOS score b.|Week 21, LOCF|FAS. LOCF = Last Observation Carried Forward.||scores on scale||Standard Deviation|Mean
731995|NCT00407797|Secondary|Treatment Satisfaction: Patient General Impression to Change (PGIC)|Patient General Impression to Change (PGIC): participant rated instrument to measure participant's change in overall status since beginning study medication on a 7-point scale; range: 1 (very much improved) to 7 (very much worse). Not done = participant did not complete the PGIC.|Week 21, LOCF|FAS. LOCF = Last Observation Carried Forward.||percent of participants|||Number
731996|NCT00407797|Secondary|Percent of Participants With >=75% Reduction in Seizure Frequency (28-day Seizure Rate) Between Baseline and Final 4 Weeks of the Treatment Observation Period||Week 17 through Week 21 (or Last 4 Weeks of Treatment after Week 9)|FAS. N=number of subjects with evaluable data.||percent of participants|||Number
731997|NCT00407797|Secondary|Percent of Participants With >=50% Reduction in Seizure Frequency (28-day Seizure Rate) Between Baseline and Final 4 Weeks of the Treatment Observation Period||Week 17 to Week 21 (or Last 4 Weeks of Treatment after Week 9)|FAS. N=number of subjects with evaluable data.||percent of participants|||Number
731998|NCT00407797|Secondary|Percent of Seizure Free Participants During the Last 4 Weeks of the Treatment Observation Period|Seizure-free = no seizures during last 4 weeks of observation period (100 percent reduction in seizures from baseline).|Week 17 to Week 21 (or Last 4 Weeks of Treatment after Week 9)|FAS. N=number of subjects with evaluable data.||percent of participants|||Number
731999|NCT00407797|Secondary|Percent of Seizure- Free Participants During the Treatment Observation Period|Seizure-free = no seizures during observation period (100 percent reduction in seizures from baseline).|Week 9 to Week 21 or Early Termination (end of treatment)|FAS. N=number of subjects with evaluable data.||percent of participants|||Number
732000|NCT00407797|Secondary|Percent Change From Baseline in Seizure Frequency in Participants Who Had <=6 Seizures and >6 Seizures During the Baseline Period|Negative values indicate a decrease in seizure frequency; positive values reflect an increase in seizure frequency.|Week 9 to Week 21 or End of Treatment (early termination)|FAS. N=number of subjects with evaluable data.||percent change||Standard Deviation|Mean
732001|NCT00407797|Secondary|Percent Change From Baseline in 28-Day Partial Seizure Frequency at Week 21|Percent change from Baseline = [(28-day seizure rate at 21 weeks minus 28-day seizure rate at baseline [b]) divided by (28-day seizure rate b) * 100. Negative values indicate a decrease in seizure frequency, positive values reflect an increase in seizure frequency.|Week 21 or End of Treatment (early termination)|FAS.||percent change||Standard Deviation|Mean
732002|NCT00407797|Secondary|Response Ratio (RR)|Response ratio (RR) = comparison between baseline 28-seizure frequency with the 12 week observation phase. RR = [(28-day seizure rate in observation period [obs] minus 28-day seizure rate at baseline [b] ) divided by (28-day seizure rate obs plus 28-day seizure rate b)] * 100. Range: -100 to 100; negative values for the RR indicate reductions in seizures.|Week 9 to Week 21 or End of Treatment (early termination)|FAS. N=number of subjects with evaluable data.||ratio||Standard Deviation|Mean
732003|NCT00407797|Primary|Percent Change From Baseline in 28 Day Partial Seizure Rate During Treatment Observation Phase|28-day seizure rate (at observation period [obs]) = [(number of seizures obs ) divided by (duration of period based on observed last dosing date and Visit 3 [Week 9] date)] * 28. Percent change = [(28-day seizure rate obs minus 28-day seizure rate at baseline [b]) divided by 28-day seizure rate b] * 100. Negative values indicate a decrease in seizure frequency and positive values reflect an increase in seizure frequency.|Week 9 to Week 21 or End of Treatment (early termination)|Full Analysis Set (FAS): all subjects who received at least 1 dose of assigned treatment, had valid baseline seizure data, and had at least 1 subsequent rating of seizure frequency (modified intent to treat population). N=number of subjects with evaluable data.||percent change||Standard Deviation|Mean
732004|NCT00407888|Secondary|Overall Survival|Count of surviving patients at two years and six years|Up to 6 years.|||Participants|||Count of Participants
732005|NCT00407888|Secondary|Time to Treatment Failure|Median time from date of start of therapy to date of removal from therapy for reason other than completion, date of first observation of recurrent disease or date of death due to any cause whichever comes first.|Up to 6 years|Outcome measure reported only for those that had an event (death, recurrent disease or removal).||years||Full Range|Median
732006|NCT00407888|Secondary|Toxicity Associated With This Regimen||After at least one course of Adriamycin, up to 12 weeks.|Some results reported are only considered amongst patients receiving Trastuzumab (n = 15).||Participants|||Count of Participants
732007|NCT00407888|Secondary|Delivered Dose Intensity of the Regimen||After at least one course of Adriamycin, up to 12 weeks.|||percentage of mean administered dose|||Number
732008|NCT00407888|Primary|Disease-free Survival Following a Dose-intensive Weekly Regimen of Adriamycin + Oral Cyclophosphamide Augmented With G-CSF Support Followed by Abraxane and Herceptin||2 years|||Participants|||Count of Participants
732009|NCT00407966|Primary|Complete Response|Bone marrow showing less than 5% myeloblasts with normal maturation of all cell lines, an Absolute Neutrophil Count of at least 1000/mililiter and a platelet count of 100,000 mililiter, absence of blast in peripheral blood, absence of identifiable leukemic cells in the bone marrow, clearance of disease-associated cytogenetic abnormalities, and clearance of any previously existing extramedullary disease. A complete remission must be confirmed 4 to 6 weeks after the initial documentation. If possible, at least one bone marrow biopsy should be performed to confirm the complete remission.|6 months|Total number of participants entered between December 2006 and June 2008||participants|||Number
732010|NCT00408070|Secondary|Determine Tolerability to 12 Months (q 3 Weeks) of Bevacizumab Maintenance Therapy||12 months||||||
732011|NCT00408070|Secondary|To Determine the Degree and Type of Toxicity of This Combined Regimen||weekly||||||
732012|NCT00408070|Secondary|Rate of Decline of CA-125||not assessed; study terminated early||||||
732013|NCT00408070|Secondary|Response to Treatment (Clinical/Pathological)||not assessed; study terminated early||||||
732014|NCT00408070|Primary|Progression Free Survival Rate at 9 Months|This Outcome is measuring the number of particpants who have survived.|9 months|||participants|||Number
732015|NCT00408200|Secondary|Freedom From Atrial Arrhythmia at 6 Months Post Procedure.||6 weeks|Assuming an incidence of the composite primary end point of 40% in the control group and a 50% reduction in the composite primary end point in the drug treatment group, we calculated that 160 patients would have to be included in the study in order to obtain a power of 80% and with a 2-tailed error of 0.05.||participants|||Number
732016|NCT00408200|Primary|Composite Endpoint: Atrial Arrhythmias Lasting >24 Hrs or Requiring Antiarrhythmic Drug Therapy; Need for Cardioversion/Repeat Ablation During the Study Period; Adverse Outcome/Intolerance of Antiarrhythmic Agent Requiring Cessation or Change of Drug||6 weeks|Assuming an incidence of the composite primary end point of 40% in the control group and a 50% reduction in the composite primary end point in the drug treatment group, we calculated that 160 patients would have to be included in the study in order to obtain a power of 80% and with a 2-tailed error of 0.05.||participants|||Number
732017|NCT00408317|Other Pre-specified|Percentage of Stool Categorized by Consistency|Stool consistency was categorized as hard, formed/normal, soft or watery stool. Percentage of stools of a specific consistency of each participant was calculated as the number of stools with a specific consistency relative to the total number of stools during the collection period. Mean percentage of stool with specific consistency on Day 4 for the first treatment period and second treatment period period for total participants was summarized.|Day 4 on first intervention period and second intervention period|ITT population included all randomized participants. Here, 'N' (number of participants analyzed) signifies those participants who were evaluated for this outcome measure.||percentage of stools||Standard Deviation|Mean
732018|NCT00408317|Other Pre-specified|Number of Bowel Movements|Number of bowel movements of each participant was calculated from frequency of stools by the participant per day. Mean daily number of bowel movements on Day 3 for the first treatment period and second treatment period was summarized.|Day 3 on first intervention period and second intervention period|ITT population included all randomized participants. Here, 'N' (number of participants analyzed) signifies those participants who were evaluated for this outcome measure.||bowel movements||Standard Deviation|Mean
732032|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure (BP) Systolic|Systolic blood pressure measured in the sitting position.|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.||mm Hg||Standard Deviation|Mean
732019|NCT00408317|Secondary|Percent Coefficient of Nitrogen Absorption (CNA)|Percent (%) CNA was calculated as [(nitrogen intake-nitrogen excretion)/nitrogen intake]*100, determined by the stools collected during the 72-hour period which could extend to 96 hours during both intervention periods. Nitrogen intake was calculated as protein intake/6.25. Mean percent CNA was calculated for 72-hour/96-hour period during Day 3 to Day 7 in the first and second intervention periods.|Day 3 to Day 7 in first intervention period and second intervention period|ITT population included all randomized participants. Here, 'N' (number of participants analyzed) signifies those participants who were evaluated for this outcome measure.||Percent CNA||Standard Deviation|Mean
732020|NCT00408317|Primary|Percent Coefficient of Fat Absorption (CFA)|Percent (%) CFA was calculated as ([fat intake - fat excretion]/fat intake)*100, determined by the stools collected during the 72-hour period which could extend to 96 hours during both intervention periods. Mean CFA percent was calculated for 72-hour/96-hour period during Day 3 to Day 7 in the first and second intervention periods.|Day 3 to Day 7 in first intervention period and second intervention period|Intent-to-Treat (ITT) population included all randomized participants. Here, 'N' (number of participants analyzed) signifies those participants who were evaluated for this outcome measure.||Percent CFA||Standard Deviation|Mean
732021|NCT00408408|Secondary|Disease-free Survival (DFS)|Percentage of patients free from local recurrence following mastectomy, local recurrence in the ipsilateral breast following lumpectomy, regional recurrence, distant recurrence, contralateral breast cancer, second primary cancer after 5 years.|Measured through 5 years after study enrollment|For Arm 1A there is no follow up data for 2 patients; Arm 1B no follow up data for 4 patients; Arm 2B no follow up data for 6 patients; Arm 3A no follow up data for 7 patients; Arm 3B no follow up data for 3 patients||percentage of patients||95% Confidence Interval|Number
732022|NCT00408408|Secondary|Toxicities Including Events Other Than Congestive Heart Failure, of Chemotherapy Alone, Bevacizumab With Chemotherapy, and Bevacizumab Alone|The number of patients who experienced Grade 1 or above Adverse Events. Referring to the Adverse Events tables for specifics.|24 months after study entry|For Arm 1A there is no followup data for 2 patients; for Arm 2A there is no followup data for 1 patient; for Arm 3A there is no followup data for 3 patients; for Arm 1B there is no followup data for 3 patients; for Arm 2B there is no followup data for 5 patients; and for Arm 3B there is no followup data for 2 patients.||participants|||Number
732023|NCT00408408|Secondary|Surgical Complication|Number of patients with Grade 4 or above surgery-related toxicities|24 months after study entry|For Arm 1A there is no follow up data for 8 patients; Arm 1B no follow up data for 8 patients; Arm 2A no follow up data for 6 patients; Arm 2B no follow up data for 12 patients; Arm 3A no follow up data for 11 patients; Arm 3B no follow up data for 7 patients||participants|||Number
732024|NCT00408408|Secondary|Percentage of Cardiac Events||After each cycle, 3-5 weeks postoperative, 9 and 12 months from study entry, every 6 month years 2-5, and annually years 6-10, for postoperative bevacizumab patients, every 6 weeks during postoperative therapy and at 18 months following study entry.||||||
732025|NCT00408408|Secondary|Clinical Complete Resonse: cCR as Assessed by Physical Exam at the Completion of the Sequential Chemotherapy Regimens|The percentage of patients assessed by physical exam as Clinical Complete Response according to RECIST.|Three to four weeks after the last chemotherapy dose, on average at 6 or 13 months|For Arm 1A there is no follow up data for 2 patients; Arm 1B no follow up data for 4 patients; Arm 2A no follow up data for 5 patients; Arm 2B no follow up data for 8 patients; Arm 3A no follow up data for 5 patients; Arm 3B no follow up data for 4 patients||percentage of patients||95% Confidence Interval|Number
732026|NCT00408408|Secondary|Clinical Complete Response (cCR) Following Docetaxel Alone, Docetaxel/Capecitabine, and Docetaxel/Gemcitabine Hydrochloride, With or Without Bevacizumab, as Assessed by Physical Exam at Completion of Therapy|Percentages of patients assessed as Clinical Complete Response or Clinical Partial Response according to RECIST.|Assessed at cycle 5 of chemotherapy, on average at 15 weeks|For Arm 1A there is no follow up data for 2 patients; Arm 1B no follow up data for 4 patients; Arm 2A no follow up data for 5 patients; Arm 2B no follow up data for 8 patients; Arm 3A no follow up data for 5 patients; Arm 3B no follow up data for 4 patients||percentage of patients||95% Confidence Interval|Number
732027|NCT00408408|Secondary|Clinical Overall Response: cOR as Assessed by Physical Exam at the Completion of the Sequential Chemotherapy Regimens|The percentage of patients assessed by physical exam as Clinical Complete Response or Clinical Partial Response according to RECIST.|Three to four weeks after the last chemotherapy dose on average 6 or 13 months|For Arm 1A there is no follow up data for 2 patients; Arm 1B no follow up data for 4 patients; Arm 2A no follow up data for 5 patients; Arm 2B no follow up data for 8 patients; Arm 3A no follow up data for 5 patients; Arm 3B no follow up data for 4 patients||percentage of patients||95% Confidence Interval|Number
732028|NCT00408408|Secondary|Clinical Overall Response (cOR) Following Docetaxel Alone, Docetaxel/Capecitabine, and Docetaxel/Gemcitabine Hydrochloride, With or Without Bevacizumab, as Assessed by Physical Exam at the Completion of the Docetaxel-based Portion of Chemotherapy|Percentages of patients assessed as Clinical Complete Response or Clinical Partial Response according to RECIST.|Assessed at cycle 5 of chemotherapy, on average at 15 weeks|For Arm 1A there is no follow up data for 1 patient; Arm 1B no follow up data for 5 patients; Arm 2A no follow up data for 6 patients; Arm 2B no follow up data for 7 patients; Arm 3A no follow up data for 7 patients; Arm 3B no follow up data for 4 patients||percentage of patients||95% Confidence Interval|Number
732029|NCT00408408|Secondary|pCR in the Breast and Nodes|Percentage of patients absent of histologic evidence of invasive tumor cells in the surgical breast specimen and axillary lymph nodes.|Time of surgery, on average 6 or 13 months|Arm 1A there is no follow up data for 3 patients; Arm 1B no follow up date for 6 patients; Arm 2A no follow up data for 1 patient; Arm 2B no follow up data for 11 patients; Arm 3A no follow up data for 9 patients; and Arm 3B no follow up data for 6 patients||percentage of patients||95% Confidence Interval|Number
732030|NCT00408408|Primary|Pathologic Complete Response (pCR) of the Primary Tumor in the Breast|Percentage of patients absent of histologic evidence of invasive tumor cells in the surgical breast specimen.|Time of surgery, on average 6 or 13 months|||percentage of patients||95% Confidence Interval|Number
732031|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Vital Signs - Weight||Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.||kilograms||Standard Deviation|Mean
732033|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure (BP) Diastolic|Diastolic blood pressure measured in the sitting position.|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.||mm Hg||Standard Deviation|Mean
732034|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Vital Signs - Pulse Rate|Pulse rate (heart rate) measured in the sitting position.|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.||beats per minute||Standard Deviation|Mean
732035|NCT00408421|Secondary|Statistically Significant Change From Baseline to 13 Week Endpoint in Laboratory Data - Chemistry Analytes: Uric Acid|Change from baseline to endpoint in uric acid using central laboratory reference ranges.|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.||micromole/Liter||Standard Deviation|Mean
732036|NCT00408421|Secondary|Statistically Significant Change From Baseline to 13 Week Endpoint in Laboratory Data - Chemistry Analytes: Alkaline Phosphatase|Change from baseline to endpoint in alkaline phosphatase using central laboratory reference ranges.|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.||Units/Liter||Standard Deviation|Mean
732037|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale|A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.'|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.||units on a scale||Standard Deviation|Mean
732038|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Beck Depression Inventory-II - Total Score|A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.||units on a scale||Standard Deviation|Mean
732039|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Euro-Quality of Life - 5 Dimensions (EQ-5D): US Based Index Score|The EQ-5D is an assessment of one's overall health. Consists of 5 items. Patients choose 1 of 3 options that best describe the status of each item. The EQ-5D US based index scores range from -0.11 to 1.0 where a score of 1.0 indicates perfect health. A positive change from baseline indicates health improvement.|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.||units on a scale||Standard Deviation|Mean
732040|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) - Physical Component Summary|A self-reported questionnaire that consists of 36 questions covering 8 health domains. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. The physical component summary (PCS) has been constructed based on the 8 SF-36 domains.|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.||units on a scale||Standard Deviation|Mean
732041|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) - Mental Health Component Summary|A self-reported questionnaire that consists of 36 questions covering 8 health domains. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. The mental component summary (MCS) has been constructed based on the 8 SF-36 domains.|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.||units on a scale||Standard Deviation|Mean
732042|NCT00408421|Secondary|Response to Treatment - The Number of Participants With a >=30% Reduction of Weekly Mean in 24-Hour Average Pain Severity Ratings in the Re-Randomized Treatment Phase|Number of participants who experienced a response to treatment, which was defined as having a >=30% reduction of the weekly mean in 24-hour average pain severity ratings. Response to treatment over the last 6 weeks of the trial (after patients were re-randomized) were compared to baseline measures.|Over 13 Weeks|Number of re-randomized patients with non-missing response values.||participants who responded|||Number
732064|NCT00408421|Secondary|Patient Global Impression of Improvement at 13 Week Endpoint|A scale that measures the patient's perception of improvement at the time of assessment. The score ranges from 1 (very much better) to 7 (very much worse).|13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
732043|NCT00408421|Secondary|Response to Treatment - The Number of Participants With a >= 30% Reduction of Weekly Mean in 24-Hour Average Pain Severity Ratings|Number of participants who experienced a response to treatment, which was defined as having a >=30% reduction of the weekly mean in 24-hour average pain severity ratings. This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain).|Over 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.||participants who responded|||Number
732044|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Average Interference|A self-reported scale that measures interference of pain on average of the 7 questions assessing the interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The average Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.||units on a scale||Standard Deviation|Mean
732045|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Enjoyment of Life|A self-reported scale that measures the interference of pain in the past 24 hours on enjoyment of life. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.||units on a scale||Standard Deviation|Mean
732046|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Sleep|A self-reported scale that measures the interference of pain in the past 24 hours on sleep. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.||units on a scale||Standard Deviation|Mean
732047|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Relations With Other People|A self-reported scale that measures the interference of pain in the past 24 hours on relations with other people. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.||units on a scale||Standard Deviation|Mean
732048|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Normal Work|A self-reported scale that measures the interference of pain in the past 24 hours on normal work. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.||units on a scale||Standard Deviation|Mean
732049|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Walking Ability|A self-reported scale that measures the interference of pain in the past 24 hours on walking ability. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.||units on a scale||Standard Deviation|Mean
732050|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Mood|A self-reported scale that measures the interference of pain in the past 24 hours on mood. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.||units on a scale||Standard Deviation|Mean
732051|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - General Activity|A self-reported scale that measures the interference of pain in the past 24 hours on general acitivity. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.||units on a scale||Standard Deviation|Mean
732052|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Pain Right Now Score|A self-reported scale that measures the severity of pain based on the pain right now. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.||units on a scale||Standard Deviation|Mean
732053|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Average Pain Score|A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.||units on a scale||Standard Deviation|Mean
732054|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Least Pain Score|A self-reported scale that measures the severity of pain based on the least pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.||units on a scale||Standard Deviation|Mean
732055|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) - Worst Pain Score|A self-reported scale that measures the severity of pain based on the worst pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.||units on a scale||Standard Deviation|Mean
732056|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Clinical Global Impression of Severity|Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients.|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.||units on a scale||Standard Deviation|Mean
732057|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Weekly Mean of 24-Hour Average Pain in the Re-Randomized Treatment Phase|This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). This value is the change from baseline in the weekly mean of the 24-hour average pain score on the scale.|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis in the re-randomized patients. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.||units on a scale||Standard Deviation|Mean
732058|NCT00408421|Secondary|Weekly Change From Baseline in the 24-Hour Worst Pain Score|This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). The value is the change from baseline in the weekly mean of the 24-hour worst pain score on the scale.|Over 13 Weeks|Analyses were conducted on an intent-to-treat basis. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific outcome measure were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
732059|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Weekly Mean of the 24-Hour Worst Pain Score|This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). The value is the change from baseline in the weekly mean of the 24-hour worst pain score on the scale.|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.||units on a scale||Standard Deviation|Mean
732060|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Total Score|The WOMAC index (pain, stiffness, physical function subscales) will be completed by the patient. The index has 24 questions. Each question is answered using a 5-point Likert scale (0 to 4). The Total score has a range from 0 (none) to 96 (extreme).|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.||units on a scale||Standard Deviation|Mean
732061|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Physical Function Subscale|The WOMAC index (pain, stiffness, physical function subscales) will be completed by the patient. The physical function subscale has 17 questions on physical function difficulties with every day tasks. Each question is answered using a 5-point Likert scale (0 to 4). The physical function subscale has a range of scores of 0 (none) to 68 (extreme).|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.||units on a scale||Standard Deviation|Mean
732062|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Stiffness Subscale|The WOMAC index (pain, stiffness, physical function subscales) will be completed by the patient. The stiffness subscale has 2 questions on stiffness associated with time of day (morning versus later in the day). Each question is answered using a 5-point Likert scale (0 to 4). The pain subscale has a range of scores of 0 (none) to 8 (extreme).|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.||units on a scale||Standard Deviation|Mean
732063|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Pain Subscale|The WOMAC index (pain, stiffness, physical function subscales) will be completed by the patient. The pain subscale has 5 questions on pain associated with every day tasks. Each question is answered using a 5-point Likert scale (0 to 4). The pain subscale has a range of scores of 0 (none) to 20 (extreme).|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.||units on a scale||Standard Deviation|Mean
732169|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Average Pain Score||Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
732065|NCT00408421|Primary|Weekly Change From Baseline in the 24-Hour Average Pain Rating Using an 11-Point Numerical Likert Scale Patient Diary|This is an ordinal scale assessing the 24-hour average pain with scores from 0 (no pain) to 10 (worst possible pain).|Over 13 Weeks|Analyses were conducted on an intent-to-treat basis. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific outcome measure were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
732066|NCT00408460|Secondary|Overall Survival||Every 3 months for 5 years|||months||Full Range|Median
732067|NCT00408460|Secondary|Time to Tumor Progression|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Baseline and every 2 months post treatment until the date of first documented tumor progression or date of death from any cause, whichever came first, assessed up to 5 years.|||months||Full Range|Median
732068|NCT00408460|Primary|Overall Response Rate (Complete and Partial Responses) as Assessed by RECIST Criteria|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Baseline, Week 4 of courses 2, 4 and 6|||Participants|||Count of Participants
732069|NCT00408499|Secondary|Patient Outcome|In the Phase II portion of the study, patients will be followed for both disease free progression by capturing disease progression date and for over all survival by capturing death date.|Patients will be followed until death|44 patients were enrolled into the Phase II portion of the study||Participants|||Count of Participants
732070|NCT00408499|Primary|Number of Patients Correlated With Best Overall Response.|To determine the efficacy, as measured by objective tumor response rate (RICIST criteria), of daily oral erlotinib and weekly intravenous cetuximab in patients with advanced NSCLC. Best overall response per patient will be reported below.|Every two cycles from first dose to last dose of study drugs|||Participants|||Count of Participants
732071|NCT00408499|Primary|Number of Patients Experiencing a DLT|Patients will be followed during cycle 1 for the occurrence of a protocol defined dose limiting toxicity|baseline through cycle 1 of treatment|||Participants|||Count of Participants
732072|NCT00408590|Secondary|Time to Progression|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|up to 12 months after last treatment|||Days||Full Range|Median
732073|NCT00408590|Secondary|Change in CA-125 Levels From Baseline to Last Recorded Value (up to 18 Months)|CA-125 tests are measured in units per milliliter (U/mL) and taken every cycle (up to 6-28 day cycles) during treatment and every three months up to 12 months after treatment. The change in CA-125 is calculated as the baseline CA-125 value subtracted by the last recorded value of CA-125 (up to 18 months from baseline.|baseline and up to 18 months|||U/ml||Full Range|Median
732074|NCT00408590|Secondary|Number of Responses (Complete and Partial, Stable and Progressive Disease)|Responses will be summarized separately for the MV-CEA virus and MV-NIS virus by simple descriptive summary statistics delineating complete and partial responses as well as stable and progressive disease. CA125 levels and time to progression will also be summarized descriptively. Modified Response Evaluation Criteria in Solid Tumors(RECIST v1.0) criteria will be used. For target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter(LD) of target lesions; Progression (PD): As least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD|up to 12 months after last treatment|||participants|||Number
732075|NCT00408590|Primary|Dose Limiting Toxicity|If one patient experiences a Dose limiting Toxicity(DLT), up to three additional patients will be treated at the same dose level. If DLT is observed in only one of six patients treated at a given dose level, the next cohort of three patients will be treated at the next higher dose level. If two or more patients experience DLT at a particular dose level, then the dose escalation will cease and any subsequent patients will be treated at a lower dose level. Thus finding the Max tolerated dose|up to 12 months after last treatment|All patients that received study drug for at least 4 weeks were evaluated for dose limiting toxicities.||participants with DLTs|||Number
732076|NCT00408603|Secondary|Progression-free Survival (PFS) Using Kaplan-Meier Methods|"PFS is the the time between the date the patient first received Vosaroxin and the earliest date of disease progression.
For patients who experienced disease progression, the date of disease progression will be the earliest date on which disease progression is indicated based on the rules.
For patients who died with no indication of disease progression, the date of death will be the earliest date on which death is documented based on the rules.
For patients who have no indication of disease progression or death, the censoring date will be the Date of Confirmed Contact from the last Survival Follow-Up CRF, or if not in survival follow-up, then the Assessment Date from the last GOG-RECIST CRF, or if no response assessment available, Date of Last Visit / Contact from Extended Treatment Completion CRF if in extended treatment, or from Cycle 6 Completion / Early Termination CRF if not in extended treatment."|From the first teratment of Vosaroxin to the end of Cycle 6 or 28 days after the last treatment at the end of safety follow up period if continued in the extended treatment period|Safety population which included all patients who received any amount of vosaroxin||Days||95% Confidence Interval|Median
732086|NCT00408629|Secondary|Proportion of Participants Who Achieved Sustained Mucosal Healing at Both Week 8 and Week 52|"Mucosal healing is defined as an Endoscopy Subscore of 0 or 1 as assessed by flexible sigmoidoscopy. Possible scores range from 0-3 as follows:
0 = Normal or inactive disease, 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 2 = Moderate disease (marked erythema, absent vascular pattern, friability, erosions), 3 = Severe disease(spontaneous bleeding, ulceration)."|Week 8, Week 52|Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.||Percentage of Participants|||Number
734203|NCT00425061|Secondary|Serum Interleukin-13 (IL-13) Level - Stage 2/3||Baseline, Day 8, 28, 56, 84, 112|Data for this outcome measure was not analyzed as the study was stopped early and sponsor’s decision to analyze only safety and key efficacy outcomes.|||||
732077|NCT00408603|Primary|Overall Response Rate (CR+PR) Per Investigator Assessment Based on GOG-RECIST Criteria|Response rate was calculated per investigator's tumor assessment based on GOG-RECIST, which includes radiographic imaging, physical examination results, and CA-125 levels. No independent review of CT scans (lesion assessments) was performed. CR: disappearance of all target and nontarget lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Normalization of CA125, if elevated at baseline, is required for ovarian carcinoma studies. PR is >= 30% decrease in the sum of LD of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of nontarget lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required.|GOG-RECIST assessment obtained on cycle2, 4 and 6 Day 21for patients treated with 48 mg/m2 SNS-595 and Day 28 for patients treated with 60 mg/m2, through 28 (±14) days afte the last treatment at the end of safety follow up period|Safety Population which included all patients who received any amount of vosaroxin||Participants|||Count of Participants
732078|NCT00408629|Secondary|Proportion of Inflammatory Bowel Disease Questionnaire Responders at Week 8|Response per the Inflammatory Bowel Disease Questionnaire (IBDQ) was defined as at least a 16-point increase from Baseline in total IBDQ score. The IBDQ is a 32-item questionnaire consisting of 4 dimensions: bowel-related symptoms, systemic function, social function, and emotional status. The responses to questions within each domain range from 1 (significant impairment) to 7 (no impairment), with total score ranging from 32 (very poor) to 224 (perfect health-related quality of life).|Week 8|Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.||Percentage of Participants|||Number
732079|NCT00408629|Secondary|Proportion of Inflammatory Bowel Disease Questionnaire Responders at Week 52|Response per the Inflammatory Bowel Disease Questionnaire (IBDQ) was defined as at least a 16-point increase from Baseline in total IBDQ score. The IBDQ is a 32-item questionnaire consisting of 4 dimensions: bowel-related symptoms, systemic function, social function, and emotional status. The responses to questions within each domain range from 1 (significant impairment) to 7 (no impairment), with total score ranging from 32 (very poor) to 224 (perfect health-related quality of life).|Week 52|Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.||Percentage of Participants|||Number
732080|NCT00408629|Secondary|Proportion of Participants Who Discontinued Corticosteroid Use and Achieved Clinical Remission Per Mayo Score (Sustained) at Both Weeks 32 and 52|"Clinical remission per Mayo score is defined as a total Mayo score of at least 2 and no individual subscore greater than 1. The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores:
SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease)."|Week 32, Week 52|Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.||Percentage of Participants|||Number
732081|NCT00408629|Secondary|Proportion of Participants Who Discontinued Corticosteroid Use for At Least 90 Days and Achieved Clinical Remission Per Mayo Score at Week 52|"Clinical remission per Mayo score is defined as a total Mayo score of at least 2 and no individual subscore greater than 1. The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores:
SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease)."|Baseline to Week 52|Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.||Percentage of Participants|||Number
732082|NCT00408629|Secondary|Proportion of Participants With Rectal Bleeding Subscore Indicative of Mild Disease (a Score of 0 or 1) at Week 8|"RBS ranges from 0-3 as follows:
0 = no blood seen, 1 = streaks of blood with stool less than half the time, 2 = obvious blood with stool most of the time, 3 = blood alone passed"|Week 8|Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.||Percentage of Participants|||Number
732083|NCT00408629|Secondary|Proportion of Participants With Stool Frequency Subscore Indicative of Mild Disease (a Score of 0 or 1) at Week 8|"SFS ranges from 0-3 as follows:
0 = Normal number of stools for this participant, 1 = 1-2 stools more than normal, 2 = 3-4 stools more than normal, 3 = 5 or more stools more than normal. The participant served as his/her own control."|Week 8|Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.||Percentage of Participants|||Number
732084|NCT00408629|Secondary|Proportion of Participants With Physician's Global Assessment Subscore Indicative of Mild Disease (a Score of 0 or 1) at Week 8|"The PGA includes the 3 other subscores (SFS, RBS, and Endoscopy), the participant's daily record of abdominal discomfort and functional assessment, and other observations such as physical findings and the participant's performance status. Possible scores range from 0-3 as follows:
0 = Normal (other subscores are 0), 1 = Mild disease (other subscores are mostly 1), 2 = Moderate disease (other subscores are 1 to 2), 3 = Severe disease (other subscores are 2 to 3)."|Week 8|Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.||Percentage of Participants|||Number
732085|NCT00408629|Secondary|Proportion of Participants Who Discontinued Corticosteroid Use Before Week 52 and Achieved Clinical Remission Per Mayo Score at Week 52|"Clinical remission per Mayo score is defined as a total Mayo score of at least 2 and no individual subscore greater than 1. The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores:
SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease)."|Baseline to Week 52|Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.||Percentage of Participants|||Number
732112|NCT00408694|Secondary|One- and Two-year Distant Metastases-free Rates|Estimated using the cumulative incidence method. Estimated along with their associated 95% confidence intervals.|From registration to two years.||||||
732087|NCT00408629|Secondary|Proportion of Participants Who Achieved Mucosal Healing at Week 52|"Mucosal healing is defined as an Endoscopy Subscore of 0 or 1 as assessed by flexible sigmoidoscopy. Possible scores range from 0-3 as follows:
0 = Normal or inactive disease, 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 2 = Moderate disease (marked erythema, absent vascular pattern, friability, erosions), 3 = Severe disease(spontaneous bleeding, ulceration)."|Week 52|Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.||Percentage of Participants|||Number
732088|NCT00408629|Secondary|Proportion of Participants Who Achieved Mucosal Healing at Week 8|"Mucosal healing is defined as an Endoscopy Subscore of 0 or 1 as assessed by flexible sigmoidoscopy. Possible scores range from 0-3 as follows:
0 = Normal or inactive disease, 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 2 = Moderate disease (marked erythema, absent vascular pattern, friability, erosions), 3 = Severe disease(spontaneous bleeding, ulceration)."|Week 8|Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.||Percentage of Participants|||Number
732089|NCT00408629|Secondary|Proportion of Participants Who Achieved Sustained Clinical Response Per Mayo Score at Both Week 8 and Week 52|"Clinical response per Mayo score is defined as a decrease in Mayo score of at least 3 points and at least 30% from Baseline, plus either a decrease in RBS of at least 1 point from Baseline or an absolute RBS of 0 or 1. The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores:
SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease)."|Week 8, Week 52|Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.||Percentage of Participants|||Number
732090|NCT00408629|Secondary|Proportion of Participants Who Achieved Clinical Response Per Mayo Score at Week 52|"Clinical response per Mayo score is defined as a decrease in Mayo score of at least 3 points and at least 30% from Baseline, plus either a decrease in RBS of at least 1 point from Baseline or an absolute RBS of 0 or 1. The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores:
SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease)."|Week 52|Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.||Percentage of Participants|||Number
732091|NCT00408629|Secondary|Proportion of Participants Who Achieved Clinical Response Per Mayo Score at Week 8|"Clinical response per Mayo score is defined as a decrease in Mayo score of at least 3 points and at least 30% from Baseline, plus either a decrease in rectal bleeding subscore (RBS) of at least 1 point from Baseline or an absolute RBS of 0 or 1. The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores:
SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease)."|Week 8|Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.||Percentage of Participants|||Number
732092|NCT00408629|Secondary|Proportion of Participants Who Achieved Sustained Clinical Remission Per Mayo Score at Both Week 8 and Week 52|"Clinical remission per Mayo score is defined as a total Mayo score of at least 2 and no individual subscore greater than 1. The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores:
SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease)."|Week 8, Week 52|Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.||Percentage of Participants|||Number
732093|NCT00408629|Primary|Proportion of Participants Who Achieved Clinical Remission Per Mayo Score at Week 52|"Clinical remission per Mayo score is defined as a total Mayo score of at least 2 and no individual subscore greater than 1. The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores:
SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease)."|Week 52|Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to OL treatment were considered to be non-remission.||Percentage of Participants|||Number
732094|NCT00408629|Primary|Proportion of Participants Who Achieved Clinical Remission Per Mayo Score at Week 8|"Clinical remission per Mayo score is defined as a total Mayo score of at least 2 and no individual subscore greater than 1. The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores:
Stool Frequency Subscore (SFS), Rectal Bleeding Subscore (RBS), Endoscopy Subscore, and Physician's Global Assessment Subscore (PGA), each of which ranges from 0 (normal) to 3 (severe disease)."|Week 8|Intent-to-treat (ITT) analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label (OL) treatment were considered to be non-remission.||Percentage of Participants|||Number
732095|NCT00408681|Other Pre-specified|Agents Added to Treat GVHD More Than 3 Days After Enrollment|Any systemic medication given in an effort to control graft-versus-host disease|Up to 100 days after enrollment|||Participants|||Count of Participants
732096|NCT00408681|Secondary|Causes of Death|Medical condition that made the greatest contribution in causing death|up to 6 years after enrollment|||Participants|||Count of Participants
732097|NCT00408681|Secondary|Survival|Patients who were alive at the specified time point|2 years after enrollment|||Participants|||Count of Participants
732098|NCT00408681|Secondary|Survival|Patients who were alive at the specified time point|1 year after enrollment|||Participants|||Count of Participants
732099|NCT00408681|Secondary|Survival|Patients who were alive at the specified time after enrollment|6 months after enrollment|||Participants|||Count of Participants
732100|NCT00408681|Secondary|Non-relapse Mortality|Death without prior recurrent or progressive malignancy after transplantation.|2 years after enrollment|||Participants|||Count of Participants
732101|NCT00408681|Secondary|Recurrent or Progressive Malignancy|Recurrence or progression of the malignant disease that was the reason for hematopoietic cell transplantation|2 years after enrollment|||Participants|||Count of Participants
732102|NCT00408681|Secondary|Mucosal Anatomic Recovery|Endoscopic evaluation of improvement. Categories include 1) no improvement, 2) regenerative changes, 3) limited improvement, 4) partial improvement and 5) complete response. Endoscopic manifestations of acute graft-versus-host disease include edema, erythema, mucosal ulceration and denudation. Complete mucosal recovery was defined as the appearance of intact mucosa with at least 98% of the luminal surface covered by epithelium. Partial response was defined as the appearance of mostly intact mucosa with at least 80% improvement or less than 10% denuded. Limited response was retrospectively designated to describe visible improvement that was less than partial response. Regenerative change was retrospectively designated to describe early reappearance of mucosal integrity in a previously denuded area but not sufficient to meet criteria for partial response. Failure to respond was defined as failure to meet partial response criteria.|9 to 11 weeks after starting treatment with the study product|Only 4 patients had endoscopic evaluation during this time window.||Participants|||Count of Participants
732103|NCT00408681|Secondary|Mucosal Anatomic Recovery|Endoscopic evaluation of improvement. Categories include 1) no improvement, 2) regenerative changes, 3) limited improvement, 4) partial improvement and 5) complete response. Endoscopic manifestations of acute graft-versus-host disease include edema, erythema, mucosal ulceration and denudation. Complete mucosal recovery was defined as the appearance of intact mucosa with at least 98% of the luminal surface covered by epithelium. Partial response was defined as the appearance of mostly intact mucosa with at least 80% improvement or less than 10% denuded. Limited response was retrospectively designated to describe visible improvement that was less than partial response. Regenerative change was retrospectively designated to describe early reappearance of mucosal integrity in a previously denuded area but not sufficient to meet criteria for partial response. Failure to respond was defined as failure to meet partial response criteria.|6 to 7 weeks after starting treatment with the study product|Only 3 patients had endoscopic evaluation during this time window.||Participants|||Count of Participants
732104|NCT00408681|Secondary|Mucosal Anatomic Recovery|Endoscopic evaluation of improvement. Categories include 1) no improvement, 2) regenerative changes, 3) limited improvement, 4) partial improvement and 5) complete response. Endoscopic manifestations of acute graft-versus-host disease include edema, erythema, mucosal ulceration and denudation. Complete mucosal recovery was defined as the appearance of intact mucosa with at least 98% of the luminal surface covered by epithelium. Partial response was defined as the appearance of mostly intact mucosa with at least 80% improvement or less than 10% denuded. Limited response was retrospectively designated to describe visible improvement that was less than partial response. Regenerative change was retrospectively designated to describe early reappearance of mucosal integrity in a previously denuded area but not sufficient to meet criteria for partial response. Failure to respond was defined as failure to meet partial response criteria.|5 weeks after starting treatment with the study product|Only 1 patient had endoscopic evaluation during this time window.||Participants|||Count of Participants
732105|NCT00408681|Secondary|Mucosal Anatomic Recovery|Endoscopic evaluation of improvement. Categories include 1) no improvement, 2) regenerative changes, 3) limited improvement, 4) partial improvement and 5) complete response. Endoscopic manifestations of acute graft-versus-host disease include edema, erythema, mucosal ulceration and denudation. Complete mucosal recovery was defined as the appearance of intact mucosa with at least 98% of the luminal surface covered by epithelium. Partial response was defined as the appearance of mostly intact mucosa with at least 80% improvement or less than 10% denuded. Limited response was retrospectively designated to describe visible improvement that was less than partial response. Regenerative change was retrospectively designated to describe early reappearance of mucosal integrity in a previously denuded area but not sufficient to meet criteria for partial response. Failure to respond was defined as failure to meet partial response criteria.|4 weeks after starting treatment with the study product|Only 2 patients had endoscopic evaluation during this time window.||Participants|||Count of Participants
732106|NCT00408681|Secondary|Mucosal Anatomic Recovery|Endoscopic evaluation of improvement. Categories include 1) no improvement, 2) regenerative changes, 3) limited improvement, 4) partial improvement and 5) complete response. Endoscopic manifestations of acute graft-versus-host disease include edema, erythema, mucosal ulceration and denudation. Complete mucosal recovery was defined as the appearance of intact mucosa with at least 98% of the luminal surface covered by epithelium. Partial response was defined as the appearance of mostly intact mucosa with at least 80% improvement or less than 10% denuded. Limited response was retrospectively designated to describe visible improvement that was less than partial response. Regenerative change was retrospectively designated to describe early reappearance of mucosal integrity in a previously denuded area but not sufficient to meet criteria for partial response. Failure to respond was defined as failure to meet partial response criteria.|2 to 3 weeks after starting treatment with the study product|Only 8 of the 20 enrolled patients had endoscopic evaluation during this time window.||Participants|||Count of Participants
732107|NCT00408681|Secondary|Duration of Treatment With the Study Product|Number of days from beginning of orally administered lithium carbonate to the end of orally administered lithium carbonate|Up to 6 months|||days||Full Range|Median
732108|NCT00408681|Primary|Functional Recovery|Functional recovery was defined as partial or complete resolution of gastrointestinal manifestations of acute graft-versus-host disease. Gastrointestinal manifestations of acute graft-versus-host disease include anorexia, nausea, vomiting, diarrhea, abdominal pain and bleeding. Complete response (CR) of intestinal GVHD was defined as the absence of any symptoms referable to intestinal GVHD. Partial response (PR) was defined as clearing of abdominal pain (or withdrawal of opioid analgesic requirements in patients treated for abdominal pain) and of grossly visible bleeding if present, and resolution of diarrhea or decrease in the three day average stool volume by ≥ 500 mL in patients with stool volumes of ≥ 500 mL. Progression of GVHD was defined as an increase in the three day average stool volume by > 500 mL, or the development of new abdominal pain (or new opioid analgesic requirements) or new intestinal bleeding.|at 28 days after starting treatment with the study product|||Participants|||Count of Participants
732109|NCT00408694|Secondary|One- and Two-year Overall Survival Rates|Estimated using the Kaplan-Meier method. Estimated along with their associated 95% confidence intervals.|From registration to two years.||||||
732110|NCT00408694|Secondary|One- and Two-year Progression-free Survival Rates|Estimated using the Kaplan-Meier method. Estimated along with their associated 95% confidence intervals.|From registration to two years.||||||
732111|NCT00408694|Secondary|One- and Two-year Loco-regional Progression-free Rates|Estimated using the cumulative incidence method. Estimated along with their associated 95% confidence intervals.|From registration to two years.||||||
732114|NCT00408694|Secondary|Patient Tolerability to Each Component (Concurrent and Adjuvant) of the Protocol Treatment Regimen|Estimated using a binomial distribution along with their associated 95% confidence intervals. Evaluated in terms of protocol treatment delivery. Measured by the percentage of patients who received 2 or more cycles of cisplatin (CDDP) and bevacizumab (BV) during concurrent treatment with RT and RT scored by the study chair as no variation or minor variation. Tolerability for the adjuvant component will be measured by the percentage of patients who received 2 or more cycles of CDDP and 5-FU and BV during the adjuvant treatment phase.|109 From start of treatment to end of treatment (approximately day 109).||||||
732115|NCT00408694|Secondary|Grade 4 Hemorrhage or Any Grade 5 Adverse Event Assessed to be Definitely, Probably, or Possibly Related to Protocol Treatment After the First Year.|Estimated using a binomial distribution along with their associated 95% confidence intervals. Graded using the CTCAE version 3.0.|From day 366 to end of follow-up.||||||
732116|NCT00408694|Primary|Grade 4 Hemorrhage or Any Grade 5 Adverse Event Assessed to be Definitely, Probably, or Possibly Related to Protocol Treatment During the First Year.|Estimated using a binomial distribution along with their associated 95% confidence intervals. Graded using the CTCAE version 3.0.|From start of treatment to one year.|Eligible patients who started study treatment.||participants|||Number
732117|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Vital Signs - Weight||Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||kilograms||Standard Error|Least Squares Mean
732118|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Vital Signs - Diastolic Blood Pressure||Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||mm Hg||Standard Error|Least Squares Mean
732119|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Vital Signs - Systolic Blood Pressure||Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||mm Hg||Standard Error|Least Squares Mean
732120|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Vital Signs - Pulse Rate||Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||beats per minute||Standard Error|Least Squares Mean
732121|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Uric Acid||Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||micromole/Liter||Standard Deviation|Mean
732122|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Potassium||Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||millimole/Liter||Standard Deviation|Mean
732123|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Creatinine||Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||micromole/Liter||Standard Deviation|Mean
732124|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Cholesterol||Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||millimole/Liter||Standard Deviation|Mean
732125|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Chloride||Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||millimole/Liter||Standard Deviation|Mean
732126|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Bilirubin, Total||Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||micromole/Liter||Standard Deviation|Mean
732127|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Bilirubin, Direct||Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||micromole/Liter||Standard Deviation|Mean
732128|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Bicarbonate, HCO3||Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||millimole/Liter||Standard Deviation|Mean
732129|NCT00408876|Secondary|Change From Baseline to 13 Week Endpoint in Laboratory Assessments - Alanine Transaminase||Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||Units/Liter||Standard Deviation|Mean
732130|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Laboratory Assessments - Alkaline Phosphatase||Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||Units/Liter||Standard Deviation|Mean
732131|NCT00408876|Secondary|Adverse Events Reported as Reason for Discontinuation||Baseline to Week 13|Number of all randomized patients.||participants|||Number
732132|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale|A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.'|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
732133|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Beck Depression Inventory-II Total Score|A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
732134|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in the Euro-Quality of Life Questionnaire - 5 Dimension - US Based Index Score|The EuroQoL Questionnaire – 5 Dimension (EQ-5D) is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows patients to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 is generated for each domain. For each patient, the outcome rating on the 5 domains will be mapped to a single index through an algorithm. The index ranges between 0 and 1, with the higher score indicating a better health state perceived by the patient.|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
732135|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Vitality|The SF-36 Health Status Survey is a generic, health-related scale assessing subjects’ quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). Vitality scores range from 4-24 (higher scores indicate better health status).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
732136|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Social Functioning|The SF-36 Health Status Survey is a generic, health-related scale assessing subjects’ quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). Social functioning scores range from 2-10 (higher scores indicate better health status).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
732137|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Role-Physical|The SF-36 Health Status Survey is a generic, health-related scale assessing subjects’ quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). Role-physical scores range from 4-8 (higher scores indicate better health status).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
732138|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Role-Emotional|The SF-36 Health Status Survey is a generic, health-related scale assessing subjects’ quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). Role-emotional scores range from 3-6 (higher scores indicate better health status).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
732139|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Physical Functioning|The SF-36 Health Status Survey is a generic, health-related scale assessing subjects’ quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). Physical functioning scores range from 10-30 (higher scores indicate better health status).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
732140|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Mental Health|The SF-36 Health Status Survey is a generic, health-related scale assessing subjects’ quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). Mental health scores range from 5-30 (higher scores indicate better health status).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
732141|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - General Health|The SF-36 Health Status Survey is a generic, health-related scale assessing subjects’ quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). General health scores range from 5-25(higher scores indicate better health status).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
733246|NCT00415597|Secondary|Mean Percent Change From Baseline to 52 Weeks in Brief Pain Inventory Score (BPI) of Average Pain|Percent change in pain intensity scale. Average pain intensity over last 24 hours rated at each visit from 0=no pain to 10=worst pain.|52 weeks|Patients with data at Week 52||Percent change||Standard Deviation|Mean
732142|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Bodily Pain|The SF-36 Health Status Survey is a generic, health-related scale assessing subjects’ quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). Bodily pain scores range from 2-11 (higher scores indicate better health status).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
732143|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Physical Component Summary (PCS)|The SF-36 Health Status Survey is a generic, health-related scale assessing subjects’ quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). MCS and PCS scores=0-100 (higher scores indicate better health status).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
732144|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in the 36-item Short-Form Health Survey (SF36)- Mental Component Summary (MCS)|The SF-36 Health Status Survey is a generic, health-related scale assessing subjects’ quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). MCS and PCS scores=0-100 (higher scores indicate better health status).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
732145|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Athens Insomnia Scale|Estimates sleep difficulty. Consists of 8 items rated on a 4-point scale of 0 (no problem at all) to 3 (very serious problem). Total score of the 8-item version ranges from 0-24.|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
732146|NCT00408876|Secondary|Response to Treatment, as Defined by a 50% Reduction of Weekly Mean Score in 24-hour Average Pain Severity Ratings, Last Observation Carried Forward||Baseline to Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||participants|||Number
732147|NCT00408876|Secondary|Response to Treatment, as Defined by a 30% Reduction of Weekly Mean Score in 24-hour Average Pain Severity Ratings, Last Observation Carried Forward||Baseline to Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||participants|||Number
732148|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Average Interference|A self-reported scale that measures interference of pain on average of the 7 questions assessing the interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The average Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
732149|NCT00408876|Primary|Change From Baseline to Week 13 Endpoint in Weekly Mean of the 24-Hour Average Pain Scores|24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 13), with scores ranging from 0 (no pain) to 10 (worst possible pain).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Error|Least Squares Mean
732150|NCT00408876|Primary|Change From Baseline to Week 12 in Weekly Mean of the 24-Hour Average Pain Scores|24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 12), with scores ranging from 0 (no pain) to 10 (worst possible pain).|Baseline, Week 12|Number of randomized patients with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Error|Least Squares Mean
732151|NCT00408876|Primary|Change From Baseline to Week 11 in Weekly Mean of the 24-Hour Average Pain Scores|24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 11), with scores ranging from 0 (no pain) to 10 (worst possible pain).|Baseline, Week 11|Number of randomized patients with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Error|Least Squares Mean
732152|NCT00408876|Primary|Change From Baseline to Week 10 in Weekly Mean of the 24-Hour Average Pain Scores|24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 10), with scores ranging from 0 (no pain) to 10 (worst possible pain).|Baseline, Week 10|Number of randomized patients with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Error|Least Squares Mean
732153|NCT00408876|Primary|Change From Baseline to Week 9 in Weekly Mean of the 24-Hour Average Pain Scores|24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 1), with scores ranging from 0 (no pain) to 10 (worst possible pain).|Baseline, Week 9|Number of randomized patients with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Error|Least Squares Mean
732154|NCT00408876|Primary|Change From Baseline to Week 8 in Weekly Mean of the 24-Hour Average Pain Scores|24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 8), with scores ranging from 0 (no pain) to 10 (worst possible pain).|Baseline, Week 8|Number of randomized patients with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Error|Least Squares Mean
733340|NCT00410813|Secondary|Change in Serum Bone Turnover Markers Over Time -- TRAP|Analysis included mean values of the serum biomarker TRAP at baseline, 4, and 8 weeks.|at baseline, 4, and 8 weeks|Number of patients with samples to analyze: baseline n=66, 4 weeks n=54, 8 weeks n=52.||U/L||Standard Deviation|Mean
732155|NCT00408876|Primary|Change From Baseline to Week 7 in Weekly Mean of the 24-Hour Average Pain Scores|24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 7), with scores ranging from 0 (no pain) to 10 (worst possible pain).|Baseline, Week 7|Number of randomized patients with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Error|Least Squares Mean
732156|NCT00408876|Primary|Change From Baseline to Week 6 in Weekly Mean of the 24-Hour Average Pain Scores|24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 6), with scores ranging from 0 (no pain) to 10 (worst possible pain).|Baseline, Week 6|Number of randomized patients with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Error|Least Squares Mean
732157|NCT00408876|Primary|Change From Baseline to Week 5 in Weekly Mean of the 24-Hour Average Pain Scores|24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 5), with scores ranging from 0 (no pain) to 10 (worst possible pain).|Baseline, Week 5|Number of randomized patients with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Error|Least Squares Mean
732158|NCT00408876|Primary|Change From Baseline to Week 4 in Weekly Mean of the 24-Hour Average Pain Scores|24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 4), with scores ranging from 0 (no pain) to 10 (worst possible pain).|Baseline, Week 4|Number of randomized patients with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Error|Least Squares Mean
732159|NCT00408876|Primary|Change From Baseline to Week 3 in Weekly Mean of the 24-Hour Average Pain Scores|24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 3), with scores ranging from 0 (no pain) to 10 (worst possible pain).|Baseline, Week 3|Number of randomized patients with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Error|Least Squares Mean
732160|NCT00408876|Primary|Change From Baseline to Week 2 in Weekly Mean of the 24-Hour Average Pain Scores|24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 2), with scores ranging from 0 (no pain) to 10 (worst possible pain).|Baseline, Week 2|Number of randomized patients with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Error|Least Squares Mean
732161|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Enjoyment of Life|A self-reported scale that measures the interference of pain in the past 24 hours on enjoyment of life. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
732162|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Sleep|A self-reported scale that measures the interference of pain in the past 24 hours on sleep. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
732163|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Relations With Other People|A self-reported scale that measures the interference of pain in the past 24 hours on relations with other people. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
732164|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Normal Work|A self-reported scale that measures the interference of pain in the past 24 hours on normal work. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
732165|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Walking Ability|A self-reported scale that measures the interference of pain in the past 24 hours on walking ability. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
732166|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Mood|A self-reported scale that measures the interference of pain in the past 24 hours on mood. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
732167|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - General Activity|A self-reported scale that measures the interference of pain in the past 24 hours on general acitivity. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
732168|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Pain Right Now Score|A self-reported scale that measures the severity of pain based on the pain right now. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
736586|NCT00443040|Secondary|Time to Writing of Hospital Discharge Order||Daily for 38 days||||||
732170|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Least Pain Score|A self-reported scale that measures the severity of pain based on the least pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
732171|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Worst Pain Score|A self-reported scale that measures the severity of pain based on the worst pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
732172|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Clinical Global Impression of Severity|Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
732173|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in the 11-point Likert Scale, Weekly Mean of Worst Pain Score|The 11-point Likert scale was used for assessment of 24-hour worst pain and evaluated as weekly means. Scores range from from 0 (no pain) to 10 (worst possible pain).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
732174|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in the 11-point Likert Scale, Weekly Mean 24-Hour Night Pain Score|The 11-point Likert scale was used for assessment of 24-hour night pain and evaluated as weekly means. Scores range from from 0 (no pain) to 10 (worst possible pain).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
732175|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Roland-Morris Disability Questionnaire (RMDQ) Total Score|Roland-Morris questionnaire was completed by the patient and measured the degree of disability due to back pain. The questionnaire consists of 24 statements and the patient was instructed to put a mark next to each appropriate statement. The number of statements marked was added up by the clinician and a total score was given. The total score ranges from 0 (no disability) to 24 (severe disability).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
732176|NCT00408876|Secondary|Patient's Global Impression - Improvement (PGI-I) at Week 13 Endpoint|"A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from
1 (very much better) to 7 (very much worse)."|Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
732177|NCT00408876|Primary|Change From Baseline to Week 1 in Weekly Mean of the 24-hour Average Pain Scores|24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 1), with scores ranging from 0 (no pain) to 10 (worst possible pain).|Baseline, Week 1|Number of randomized patients with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Error|Least Squares Mean
732178|NCT00408902|Secondary|Progression-free Survival|Estimated time to progression using the method of Kaplan and Meier.|Up to 4 weeks after completion of study treatment|Intent to treat||months||Full Range|Median
732179|NCT00408902|Secondary|Overall Survival|Estimated using the method of Kaplan and Meier.|Up to 4 weeks after completion of study treatment||||||
732180|NCT00408902|Primary|Overall Efficacy, Taking Into Account Both Objective Response and Meaningful Reductions in Tumor Burden That do Not Meet the RECIST Criteria for PR or CR (e.g., 5-30% Reduction in RECIST Defined Tumor Burden)|The number of patients that reach complete response (CR)defined as the disappearance of all target lesions or partial response (PR)defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.|Up to 4 weeks after completion of study treatment|Intent to treat||participants|||Number
732181|NCT00408928|Secondary|Number of Toxicities Related to Bortezomib (VELCADE®)|Observe the toxicities of VELCADE® when administered to recipients of allogeneic hematopoietic stem cell transplant in the setting of steroid refractory or steroid dependent acute graft-versus-host disease.|Through 30 days post-traeatment|||toxicities|||Number
732182|NCT00408928|Primary|Response to Bortezomib (VELCADE®)|"Response is the primary endpoint of this study and will be scored on day 21 (3 weeks after the first dose of VELCADE) and every 3 weeks subsequently. Patients who progress or expire before the end of the study will be considered non-responders.
Patients are evaluated for response in an organ if they have AGVHD in that organ at the start of treatment with VELCADE or if AGVHD develops after the start of VELCADE, but before the time period of evaluation. Complete response in an organ is defined as no evidence clinical or biochemical signs of AGVHD. For the overall assessment, it is defined as complete resolution of rash, abnormal LFTs, and absence of diarrhea attributed to AGVHD.
Partial response is defined as a one stage decrease in any organ system without worsening in other organ systems."|Through 30 days post-treatment|||participants|||Number
732183|NCT00408993|Secondary|Statistically Significant Change From Baseline to 12 Week Endpoint in Laboratory Measures - Uric Acid|Significantly different laboratory values between the two groups in baseline to endpoint changes|Baseline and 12 weeks|Number of randomized patients with a baseline and at least one non-missing post-baseline value, based on first values at scheduled visits.||micromole/Liter||Standard Deviation|Mean
734204|NCT00425061|Secondary|Serum Interleukin-13 (IL-13) Level - Stage 1||Baseline, Day 8, 28, 56, 84, 112|Data for this outcome measure was not analyzed as the study was stopped early and sponsor’s decision to analyze only safety and key efficacy outcomes.|||||
732184|NCT00408993|Secondary|Statistically Significant Change From Baseline to 12 Week Endpoint in Laboratory Measures - Chloride, High Density Lipoprotein, Sodium, and Triglycerides|Significantly different laboratory values between the two groups in baseline to endpoint changes in chloride, high density lipoprotein, sodium, and triglycerides.|Baseline and 12 weeks|Number of randomized patients with a baseline and at least one non-missing post-baseline value, based on first values at scheduled visits.||millimole/Liter||Standard Deviation|Mean
732185|NCT00408993|Secondary|Vital Signs - Blood Pressure|Change from baseline to endpoint in systolic and diastolic blood pressure.|Baseline and 12 weeks|Number of randomized patients with a baseline and at least one non-missing post-baseline value.||mm Hg||Standard Error|Least Squares Mean
732186|NCT00408993|Secondary|Vital Signs - Pulse Rate|Change from baseline to endpoint in pulse rate.|Baseline and 12 weeks|Number of randomized patients with a baseline and at least one non-missing post-baseline value.||beats per minute||Standard Error|Least Squares Mean
732187|NCT00408993|Secondary|Vital Signs - Weight|Change from baseline to endpoint in body weight.|Baseline and 12 weeks|Number of randomized patients with a baseline and at least one non-missing post-baseline value.||kilograms||Standard Error|Least Squares Mean
732188|NCT00408993|Secondary|Change From Baseline to 12 Week Endpoint in Athens Insomnia Scale 8-item and 5-item|Estimates sleep difficulty. Consists of 8 items rated on a 4-point scale of 0 (no problem at all) to 3 (very serious problem). Total score of the 8-item version (sum of items 1-8) ranges from 0-24, while total score of the 5-item (sum of items 1-5) ranges from 0-15.|Baseline and 12 weeks|Intention to Treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Error|Least Squares Mean
732189|NCT00408993|Secondary|Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening)|Tolerability of morning versus evening dosing, as assessed by the number of participants with spontaneously reported adverse events.|over 12 weeks|Number of randomized patients in each treatment arm for each dosing group||participants|||Number
732190|NCT00408993|Secondary|Number of Participants Discontinuing Due to Adverse Events||over 12 weeks|Intention to Treat Analysis. All randomized patients.||participants|||Number
732191|NCT00408993|Secondary|Change From Baseline to 12 Week Endpoint in EuroQoL Questionnaire – 5 Dimensions (EQ-5D) (US Based Index Score)|The EQ-5D is an assessment of one's overall health. Consists of 5 items. Patients choose 1 of 3 options that best describe the status of each item. The EQ-5D US based index scores range from -0.11 to 1.0 where a score of 1.0 indicates perfect health. A positive change from baseline indicates health improvement.|Baseline and 12 weeks|Intention to Treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Error|Least Squares Mean
732192|NCT00408993|Secondary|Time Course of Change in Patient Global Impression - Improvement Scale|A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).|baseline, over 12 weeks|Intention to Treat analysis. Number of randomized patients with at least one non-missing post-baseline data.||units on a scale||Standard Error|Least Squares Mean
732193|NCT00408993|Secondary|Change From Baseline to 12 Week Endpoint in Clinical Global Impression of Severity|Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients.|Baseline and 12 weeks|Intention to Treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Error|Least Squares Mean
732194|NCT00408993|Secondary|Change From Baseline to 12 Week Endpoint in Brief Pain Inventory (BPI) Worst Pain, Least Pain, and Current Pain Severity and Average Interference Scores|Measures severity of pain and interference of pain on function. Each severity of pain (worst, least, and current) scores range from 0 (no pain) to 10 (pain as severe as you can imagine). The 7 separate Interference item scores range from 0 (does not interfere) to 10 (completely interferes) and were averaged to provide a single score (0 to 10).|Baseline and 12 weeks|Intention to Treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Error|Least Squares Mean
732195|NCT00408993|Primary|Change From Baseline to 12 Week Endpoint in Brief Pain Inventory 24-hour Average Pain Score|A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline and 12 weeks|Intention to Treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Error|Least Squares Mean
732196|NCT00409006|Secondary|Overall Survival|Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact. Median overall survival could not be estimated as most participants were living at the end of the study. 25 participants from each treatment group were censored. In place of this outcome measure, the percentage of participants who died during the study are provided in the Post-Hoc Analysis Outcome Measure: Percentage of Participants Who Died During the Study.|Baseline to date of death from any cause, 12 weeks up to 31 months|Randomized and treated population includes all randomized patients. Patients are analyzed according to the treatment they actually received (ITT population). Median overall survival could not be estimated as most participants were living at the end of the study.||Months||95% Confidence Interval|Median
732197|NCT00409006|Post-Hoc|Percentage of Participants Who Died During the Study|This outcome measure takes the place of the outcome measure for Overall Survival, which could not be reported since the median value could not be calculated.|Baseline up to 31 months|Randomized and treated population includes all randomized patients. Patients are analyzed according to the treatment they actually received (ITT population). 25 participants from each treatment group were censored.||Percentage of Participants|||Number
732198|NCT00409006|Secondary|Duration of Response for Responders|The duration of a complete response (CR; the disappearance of all target lesions) or partial response (PR; at least a 30% decrease in the sum of the longest diameter of target lesions) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. A responder is a patient exhibiting a best overall study response of CR or PR.|Time of response to progressive disease or death, 12 weeks up to 31 months|Qualified for Response population includes all treated patients with measurable disease prior first dose of study therapy. Patients were censored for this analysis (2 pemetrexed/cisplatin/gefitinib and 2 pemetrexed/cisplatin).||Months||95% Confidence Interval|Median
732199|NCT00409006|Secondary|Number of Participants With Tumor Response|Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes not meeting above criteria. Responder is a participant exhibiting a best overall study response of CR or PR.|Baseline to measured response or death, 12 weeks up to 31 months|Qualified for Response population includes all treated patients with measurable disease prior first dose of study therapy.||Participants|||Number
732200|NCT00409006|Primary|Progression-Free Survival (PFS)|Defined as the time from randomization to the first observation of disease progression, or death due to any cause.|Baseline to first observation of disease progression or death, 12 weeks up to 31 months|Randomized and treated (RT) population includes all randomized patients. Patients are analyzed according to the treatment they actually received (intent-to-treat [ITT] analysis). Patients were censored from this analysis (8 pemetrexed/cisplatin/gefitinib and 11 pemetrexed/cisplatin).||Months||95% Confidence Interval|Median
732201|NCT00409175|Secondary|Percentage of Participants With Stabilized Transthyretin (TTR) Tetramer|TTR tetramer was assessed using a validated immunoturbidimetric assay. The Fraction of Initial (FOI) is the ratio of the measured TTR tetramer concentration after denaturation to the measured TTR tetramer concentration before denaturation. TTR tetramer stabilization is based on the difference between the on-treatment FOI and the baseline FOI expressed as a percentage of the baseline FOI.|Week 8, Month 6, 12, 18|ITT population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ = those participants who were evaluable for this measure at given time points for each group respectively.||percentage of participants||95% Confidence Interval|Number
732202|NCT00409175|Secondary|Change From Baseline in Modified Body Mass Index (mBMI) at Month 6, 12 and 18|BMI was calculated by weight divided by height squared. mBMI was calculated by multiplying BMI by serum albumin levels to compensate for edema formation associated with malnutrition. A progressive decline in mBMI indicated worsening of disease severity.|Baseline, Month 6, 12, 18|ITT population included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy assessment for NIS-LL and Norfolk QOL-DN or discontinued study due to death/LT. ‘n’ = those participants who were evaluable for this measure at given time points for each group respectively.||(kilogram/square meter)*(gram/liter)||Standard Deviation|Mean
732203|NCT00409175|Secondary|Change From Baseline in Summated 3 Score for Small Nerve Fiber Function at Month 6, 12 and 18|Summated 3 Nerve Tests Small Fiber Normal Deviates Score (NTSFnds) included cooling threshold for the lower limbs, heat pain threshold for the lower limbs and HRDB. Total score range= -11.2 to 11.2, where higher score=worse nerve function.|Baseline, Month 6, 12, 18|ITT population included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy assessment for NIS-LL and Norfolk QOL-DN or discontinued study due to death/LT. ‘n’ = those participants who were evaluable for this measure at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
732204|NCT00409175|Secondary|Change From Baseline in Summated 7 Score for Large Nerve Fiber Function at Month 6, 12 and 18|Summated 7 score: composite score included five Nerve Conduction Studies (NCS) attributes (peroneal nerve distal motor latency, peroneal nerve compound muscle action potential, peroneal nerve motor conduction velocity, tibial nerve distal motor latency, and sural nerve sensory nerve action potential amplitude) along with Vibration Detection Threshold (VDT) obtained in great toes, and Heart Rate Response to Deep Breathing (HRDB) value. Score was determined through reference to normal values for age, sex and height. Total score range= -26 to 26, where higher score=worse nerve function.|Baseline, Month 6, 12, 18|ITT population included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy assessment for NIS-LL and Norfolk QOL-DN or discontinued study due to death/LT. ‘n’ = those participants who were evaluable for this measure at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
732205|NCT00409175|Secondary|Change From Baseline in Norfolk Quality of Life - Diabetic Neuropathy (QOL-DN) Domain Scores at Month 6, 12 and 18|Norfolk QOL-DN:35-item participant-rated questionnaire to assess impact of DN on QOL; Item 1-7:scored as 1=symptom present, 0=symptom absent. Item 8-35: scored on 5-point Likert scale: 0=no problem, 4=severe problem (except item 32: -2=much better, 0=about same, 2=much worse). Norfolk QOL-DN summarized in 5 domains(score range):physical functioning/large fiber neuropathy(-2 to 58), activities of daily living(ADLs) (0 to 20), symptoms(0 to 32), small fiber neuropathy(0 to 16), autonomic neuropathy(0 to 12); higher score=greater impairment, for each. Total score=-2 to138(higher score=worse QOL).|Baseline, Month 6, 12, 18|ITT population included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy assessment for NIS-LL and Norfolk QOL-DN or discontinued study due to death or LT. ‘n’ = those participants who were evaluable for this measure at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
732206|NCT00409175|Secondary|Change From Baseline in Norfolk Quality of Life - Diabetic Neuropathy (QOL-DN) Total Quality of Life (TQOL) Score at Month 6 and 12|Norfolk QOL-DN: 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy; Item 1 to 7: related to symptoms and presence of symptom was assessed as 1 and absence was assessed as 0. Item 8-35: related to activities of daily living and scored on a 5-point Likert scale, where 0= no problem and 4= severe problem (except item 32, where -2= much better, 0=about the same, 2=much worse). TQOL= sum of all the items, total possible score range= -2 to 138, where higher score=worse quality of life.|Baseline, Month 6, 12|ITT population included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy assessment for NIS-LL and Norfolk QOL-DN or discontinued study due to death/LT. ‘n’ = those participants who were evaluable for this measure at given time point for each group respectively.||units on a scale||Standard Deviation|Mean
732215|NCT00409188|Primary|Overall Survival|Overall survival time was defined as the time from randomization to death. Participants without events were censored at the last date they were known to be alive or the clinical cut-off date, whatever was earlier.|Up to 66 months|Primary analysis set (modified intention-to-treat [ITT] population) was based on the ITT population but prospectively excluded all participants (274 participants) that were randomized during the 6 months (22 Sep 2009 to 22 Mar 2010) prior to the effective date of clinical hold.||months||95% Confidence Interval|Median
734273|NCT00425269|Secondary|Triglycerides, Baseline||baseline|||mmol/L||95% Confidence Interval|Mean
732207|NCT00409175|Secondary|Percentage of Participants With Response to Treatment as Measured by Neuropathy Impairment Score - Lower Limb (NIS-LL) at Month 6 and 12|Response to treatment was indicated by either improvement (decrease from baseline) or stabilization (change from baseline of 0 to <2) in NIS-LL score, based on mean of 2 scores in 1 week period. NIS-LL: assessed muscle weakness, reflexes, sensation. Each item scored separately for left, right limbs. Components of muscle weakness scored on 0 (normal) to 4 (paralysis) scale, higher score=greater weakness. Components of reflexes, sensation scored 0=normal, 1=decreased, or 2=absent. Total NIS-LL score range 0-88, higher score=greater impairment.|Month 6, 12|ITT population included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy assessment for NIS-LL and Norfolk QOL-DN or discontinued study due to death/LT. LOCF method was used; participant who discontinued due to death/LT was set non-responder.||percentage of participants||95% Confidence Interval|Number
732208|NCT00409175|Secondary|Change From Baseline in Neuropathy Impairment Score- Lower Limb (NIS-LL) Score at Month 6, 12 and 18|NIS-LL: assessed muscle weakness, reflexes and sensation; scored separately for left and right limbs. Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) are scored on 0(normal) to 4(paralysis) scale, higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae) and sensation (touch pressure, pin-prick, vibration, joint position) were scored 0 = normal, 1= decreased, or 2 = absent. Total possible NIS-LL score range 0-88, higher score=greater impairment.|Baseline, Month 6, 12, 18|ITT population included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy assessment for NIS-LL and Norfolk QOL-DN or discontinued study due to death/LT. ‘n’ = those participants who were evaluable for this measure at given time point for each group respectively.||units on a scale||Standard Deviation|Mean
732209|NCT00409175|Primary|Change From Baseline in Norfolk Quality of Life- Diabetic Neuropathy (QOL-DN) Total Quality of Life (TQOL) Score at Month 18|Norfolk QOL-DN: 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy; Item 1 to 7: related to symptoms and presence of symptom was assessed as 1 and absence was assessed as 0. Item 8-35: related to activities of daily living and scored on a 5-point Likert scale, where 0= no problem and 4= severe problem (except item 32, where -2= much better, 0=about the same, 2=much worse). TQOL= sum of all the items, total possible score range= -2 to 138, where higher score=worse quality of life.|Baseline, Month 18|ITT population included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy assessment for NIS-LL and Norfolk QOL-DN or discontinued study due to death or LT. LOCF method was used.||units on a scale||Standard Deviation|Mean
732210|NCT00409175|Primary|Percentage of Participants With Response to Treatment as Measured by Neuropathy Impairment Score - Lower Limb (NIS-LL) at Month 18|Response to treatment was indicated by either improvement (decrease from baseline) or stabilization (change from baseline of 0 to less than[<] 2) in NIS-LL score, based on mean of 2 scores in 1 week period. NIS-LL: assessed muscle weakness, reflexes, sensation. Each item scored separately for left, right limbs. Components of muscle weakness scored on 0(normal) to 4(paralysis) scale, higher score=greater weakness. Components of reflexes, sensation scored 0=normal, 1=decreased, or 2=absent. Total NIS-LL score range 0-88, higher score=greater impairment.|Month 18|ITTset:randomized participants received atleast(>=)1 dose of study drug, had >=1 post-baseline efficacy assessment for NIS-LL,Norfolk Quality of Life-Diabetic Neuropathy(QOL-DN) or discontinued study due to death/liver transplant(LT).Last-observation-carried-forward(LOCF) used;participant who discontinued due to death/LT was set non-responder.||percentage of participants||95% Confidence Interval|Number
732211|NCT00409188|Secondary|Number of Participants With Treatment Emergent Adverse Events and Injection Site Reactions|Treatment -emergent adverse events were defined as those with onset or worsening occurring at or after the first dosing day of study medication and up to 42 days after the last administration of any study drug or the clinical cut-off date. Injection site reactions were reported as assessed by the Investigator.|From first dose up to 42 days after the last dose of the trial treatment|Safety analysis set included all participants who received at least 1 dose of trial treatment (cyclophosphamide, tecemotide, saline, or placebo). Participants were reported based on the actual treatment received (as-treated).||participants|||Number
732212|NCT00409188|Secondary|One-, Two- and Three-year Survival Rate|The percentages of participants who were alive at 1, 2, and 3 years were calculated as a cumulative percentage by Kaplan-Meier survival analysis approach.|Years 1, 2, and 3|Primary analysis set (modified ITT population) was based on the ITT population but prospectively excluded all participants (274 participants) that were randomized during the 6 months (22 Sep 2009 to 22 Mar 2010) prior to the effective date of clinical hold.||percentage of participants|||Number
732213|NCT00409188|Secondary|Time To Progression (TTP)|Time from randomization to disease progression. Disease progression was defined based on Response Evaluation Criteria in Solid Tumors Version 1.0 [RECIST v1.0]) as at least a 20% increase in the sum of the longest diameter of target lesions from nadir, or the appearance of one or more new lesions.|Up to 66 months|Primary analysis set (modified ITT population) was based on the ITT population but prospectively excluded all participants (274 participants) that were randomized during the 6 months (22 Sep 2009 to 22 Mar 2010) prior to the effective date of clinical hold.||months||95% Confidence Interval|Median
732214|NCT00409188|Secondary|Time To Symptom Progression (TTSP) as Measured by the Lung Cancer Symptom Scale (LCSS)|Time to symptom progression (TTSP) was measured by LCSS. Symptomatic progression was defined as an increase (worsening) of the Average Symptomatic Burden Index (ASBI that is, the mean of the six major lung cancer specific symptom scores of the LCSS patient scale – ranging from 0 to 100 where higher score indicates worst outcome). Worsening was defined as a 10% increase in the scale breadth from the baseline score. TTSP is defined as the time from randomization to worsening in ASBI. Participants without event are censored at the date of the last LCSS assessment.|Up to 66 months|"Primary analysis set (modified ITT population) was based on the ITT population but prospectively excluded all participants (274 participants) that were randomized during the 6 months (22 Sep 2009 to 22 Mar 2010) prior to the effective date of clinical hold. N signifies the number of participants who were evaluable for this outcome measure."||months||95% Confidence Interval|Median
733247|NCT00415597|Secondary|Mean Percent Change From Baseline to 12 Weeks in Brief Pain Inventory Score (BPI) of Average Pain|Percent change in pain intensity scale. Average pain intensity over last 24 hours rated at each visit from 0=no pain to 10=worst pain.|12 weeks|Patients with data at Week 12||Percent change||Standard Deviation|Mean
732216|NCT00409240|Primary|Percent of Patients Achieving Hemoglobin A1C Goal, LDL Cholesterol Goal, and Systolic Blood Pressure Goal From the Enrollment Until the End of the Study|Hemoglobin A1C target was < 7% LDL cholesterol goal of < 100mg/dl or <70mg/dl for patients at high risk-current cardiovascular disease Systolic blood pressure goal of <130mm Hg|6 months|||participants|||Number
732217|NCT00409292|Secondary|to Assess Overall Survival Associated With RAD001 in This Patient Population.|Overall survival was defined as the time from study entry until death from any cause.|2 years|||months||Full Range|Median
732218|NCT00409292|Secondary|to Assess Response Rate Associated With RAD001 in This Patient Population.|The secondary objectives of the study were to assess tumor response rate and overall survival. Patients were required to have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST). Per RECIST, for target lesions assessed by CT: Complete Response (CR) is Disappearance of all target lesions; Partial Response (PR) is >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) equals CR + PR.|2 years|Of the 33 patients enrolled, 29 reached restaging. Three patients who did not reach restaging were removed from study because of withdrawal of consent. One patient was removed from study after 8 days of treatment because of worsening of a preexisting perirectal fistula, requiring surgical intervention.||participants|||Number
732219|NCT00409292|Secondary|To Assess the Safety of RAD001 in Patients With Metastatic Pancreatic Cancer|Patients were followed for the duration of their time on treatment and 30 days after their last dose of RAD001. The number of patients with treatment-related adverse events are reported.|Patients were followed for the duration of their time on treatment and 30 days after their last dose of RAD001.|A total of 33 eligible patients received at least 1 week of study drug and are included in our toxicity analyses.||participants|||Number
732220|NCT00409292|Primary|To Assess Progression-free Survival of RAD001 at Two Months in Patients With Metastatic Pancreatic Cancer Whose Disease Has Progressed on Gemcitabine Chemotherapy.|"The Outcome Measure is reporting the number of participants experiencing Progression-free Survival at 2 months after treatment.
The study was designed with a primary end point of progression-free survival (PFS), defined as the time from study entry to documentation of progressive disease or death from any cause. On the basis of prior studies of second-line treatment in metastatic pancreatic cancer, we estimated that such treatment has been associated with a median PFS of 2 months. Our study design used a one-stage design with a target accrual of 35 eligible patients, with the assumption that an improvement in PFS at 2 months from 50% to 71% would warrant further study in this patient population."|two months|On the basis of prior studies of 2nd line treatment in metastatic pancreatic cancer, we estimated a median PFS of 2 months. Our study design used a one-stage design with a target accrual of 35 eligible patients, with the assumption that an improvement in PFS at 2 months from 50% to 71% would warrant further study in this population.||participants|||Number
732221|NCT00409331|Primary|12-month Clinically Relevant Salivary Flow (CRSF)|Primary endpoint is bilateral, 12-month Clinically Relevant Salivary Flow (CRSF) by the submandibular and sublingual salivary glands, collectively. Saliva production will be quantified using selective quantitative submandibular sialometry (total collection time of 5 minutes). A CRSF is equivalent to production of 0.05 mL of saliva post-radiation in a 5-minute collection period.|12 months|No analysis performed; study terminated early due to change in sponsor.|||||
732222|NCT00409344|Primary|Intensive Care Unit Length of Stay|The number of days each patient was in the Intensive Care Unit. Unable to measure this outcome due to no enrollment of participnats.|1/1/2008|||Days|||Number
732223|NCT00409344|Secondary|Incidence of Delirium; Number of Shifts During Which Delirium Was Diagnosed|Did not achieve this outcome due to no enrollment of participants. Was unable to measure this outcome.|1/1/2008|||participants|||Number
732224|NCT00409344|Secondary|Pharmaco-economics|Did not achieve this outcome due to no enrollment of participants|1/1/2008|||participants|||Number
732225|NCT00409344|Secondary|Amount of Vasoactive Substances Used to Achieve Hemodynamic Stability|Did not achieve this outcome due to no enrollment of participants, unable to measure this outcome|1/1/2008|||participants|||Number
732226|NCT00409344|Secondary|Time to Extubation|Did not achieve this outcome due to no enrollment of participants|1/1/2008|||hours|||Number
732227|NCT00409344|Secondary|Secondary Endpoints Include:Amount of Sedative and Opiates Given|Did not achieve this outcome due to no enrollment of participants|1/1/2008|||milligram of sedative an opiate|||Number
732228|NCT00409344|Primary|Time to a Successful Spontaneous Breathing Trial.|Did not achieve this primary outcome due to no enrollment of participants. Unable to measure this outcome.|1/1/2008|||hours|||Number
732229|NCT00409409|Primary|Average Rhinoconjunctivitis Total Symptom Score (ARTSS)|"Average Rhinoconjunctivitis Total Symptom Score during the pollen period while participant on treatment.
Participants assessed daily, during the pollen period, 6 rhinoconjunctivitis symptoms (sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes) each symptom is scored as follows: 0: no symptoms, 1: mild symptoms, 2: moderate symptoms, 3: severe symptoms. The sum of the 6 symptoms is the Rhinoconjunctivitis Total Symptom Score (RTSS) (range 0-18). The lower the score, the better the outcome."|Pollen period (average of 38.6 days)|The Intent-to-treat (ITT) population included all patients who received at least one dose of the investigational product and had a Retrospective Rhinoconjunctivitis Total Symptom Score (RRTSS) and at least one Rhinoconjunctivitis Total Symptom Score (RTSS) in the pollen period while on treatment.||Units on a scale (range: 0 to 18)||Standard Deviation|Mean
733248|NCT00415597|Primary|Subjects With Treatment Emergent Adverse Events|Number of subjects with adverse events (any unfavorable and unintended sign, symptom, or disease temporally associated with the use of the product whether or not related to the product).|up to 12 months|Patients treated with study drug||participants|||Number
732237|NCT00409578|Secondary|Percentage of Patients With a Composite Clinical-biochemical Event|A composite clinical-biochemical event was defined as at least one of the following events: cardiovascular death confirmed by adjudication, recurrent MI confirmed by adjudication, hospitalization for CHF confirmed by adjudication, and/or NT-proBNP => 200 pg/mL.|Baseline to Week 8|Full analysis set: All patients who were correctly randomized. Missing baseline values were not imputed. The last post-baseline biomarker measurement collected was used for analysis. In the aliskiren treated group, 4 patients never received study drug but were included in the full analysis set but were not included in any efficacy analyses.||Percentage of patients|||Number
732238|NCT00409578|Secondary|Percentage of Patients With a Cardiac Event|A cardiac event was defined as at least one of the following events: Cardiovascular death, recurrent myocardial infarction (MI), or hospitalization for congestive heart failure (CHF), all to be confirmed by adjudication.|Baseline to Week 8|Full analysis set: All patients who were correctly randomized. Missing baseline values were not imputed. The last post-baseline biomarker measurement collected was used for analysis. In the aliskiren treated group, 4 patients never received study drug but were included in the full analysis set but were not included in any efficacy analyses.||Percentage of patients|||Number
732239|NCT00409578|Secondary|Change From Baseline in B-type Natriuretic Peptide (BNP) at Week 8|Blood samples for the measurement of BNP were collected, processed, and shipped to the TIMI Biomarker Core Laboratory, Boston MA for storage and analysis. The change from baseline to Week 8 was expressed as the geometric mean of the ratio: Week 8/Baseline.|Baseline to Week 8|Full analysis set: All patients who were correctly randomized. Missing baseline values were not imputed. The last post-baseline biomarker measurement collected was used for analysis. In the aliskiren treated group, 4 patients never received study drug but were included in the full analysis set but were not included in any efficacy analyses.||pg/mL||95% Confidence Interval|Geometric Mean
732240|NCT00409578|Primary|Change From Baseline in N-terminal proB-type Natriuretic Peptide (NT-proBNP) at Week 8|Blood samples for the measurement of NT-proBNP were collected, processed, and shipped to the TIMI Biomarker Core Laboratory, Boston MA for storage and analysis. The change from baseline to Week 8 was expressed as the geometric mean of the ratio: Week 8/Baseline.|Baseline to Week 8|Full analysis set: All patients who were correctly randomized. Missing baseline values were not imputed. The last post-baseline biomarker measurement collected was used for analysis. In the aliskiren treated group, 4 patients never received study drug but were included in the full analysis set but were not included in any efficacy analyses.||pg/mL||95% Confidence Interval|Geometric Mean
732241|NCT00409617|Secondary|Mean Change in Activity Impairment Score From Baseline to Week 20|Daily activity is one component of the Work Productivity and Activity Impairment Questionnaire. 0% = no impairment. A decrease in the mean indicates improvement.|Week 20 of treatment|The ITT population, defined as participants who received at least 1 injection of adalimumab, was used. Data for 902 participants were available for calculating change from Baseline at Week 20 of treatment. Missing values were imputed by LOCF.||Percent activity impairment||Standard Deviation|Mean
732242|NCT00409617|Secondary|Mean Change in Overall Work Productivity and Activity Impairment Score From Baseline to Week 20|6-items that assess impairment in work productivity and daily activity during the 7 days before the assessment. It measures the percentage of overall impairment in work productivity and daily activity due to CD. A WPAI score of 0% = no impairment and a score of 100% = total loss of work productivity or activity. An absolute change in WPAI score of 7% is considered the minimum clinically important difference (MCID).|Week 20 of treatment|The ITT population, defined as participants who received at least 1 injection of adalimumab, was used in the analysis. Data were available for 346 participants for the calculation of mean change in Overall Impairment from Baseline to Week 20. Data were imputed using LOCF.||Percent total impairment||Standard Deviation|Mean
732243|NCT00409617|Secondary|Mean Change in Percent Impairment While Working From Baseline to Week 20 of Treatment|Percent impairment while working is a component of the Work Productivity and Activity Impairment measure. A score of 0% = no impairment. A decrease in mean score indicates lessening of impairment.|Week 20 of treatment|The ITT population, defined as participants who received at least 1 injection of adalimumab, was used in the analysis. Data were available for 382 participants for the calculation of mean change in Percent Impairment While Working from Baseline to Week 20. Data were imputed using LOCF.||Percent impairment at work||Standard Deviation|Mean
732244|NCT00409617|Secondary|Mean Change in Percent Work Time Missed Due to Crohn's Disease From Baseline to Week 20 of Treatment|Percent Work Time Missed (Absenteeism) due to CD is one component of the Work Productivity and Activity Impairment (WPAI) Questionnaire. Score of 0% = no impairment. A decrease in the mean indicates improvement.|Week 20 of treatment|The ITT population, defined as participants who received at least 1 injection of adalimumab, was used in the analysis. 369 participants had data available for calculating change in Percent Work Time Missed. Missing values were imputed using LOCF.||Percent of work time missed||Standard Deviation|Mean
732245|NCT00409617|Secondary|Mean Change in Total Score of Short Inflammatory Bowel Disease Questionnaire (SIBDQ) From Baseline to Week 20|10-item assessment of health-related quality of life (QoL) in patients with inflammatory bowel disease. Participant marks an option from 1 to 7 for each item. For some items, 1=None of the time; for other items, 1=All of the time. Value for all items are summed. Total score=10 to 70; a high score=good quality of life (QoL). An increase in score indicates improvement. An absolute change in the SIBDQ score of 9 is considered a minimum clinically important difference (MCID) for a patient.|Week 20 of treatment|The ITT population, defined as participants who received at least 1 injection of adalimumab, was used in the analysis. 907 participants had data available for calculating change in total score of SIBDQ. Missing values were imputed using LOCF.||Change in total score||Standard Deviation|Mean
732246|NCT00409617|Secondary|Number of Participants Who Had Extra-intestinal Manifestations (EIM) at Baseline and Resolution by Week 20.|Number of participants who had EIM at baseline and had resolution of those manifestations at Week 20. EIM were skin lesions, eye lesions, joint complaints, CD-related hepatic disease, thrombosis, and nephrolithiasis. EIMs were determined by physical examination.|Week 20 of treatment|"497 participants who received at least 1 injection of adalimumab (ITT population) had baseline EIM data. Missing data were imputed using non-responder imputation; participants who discontinued the study before Week 20 and participants with missing value at Week 20 were counted as no for resolution."||Participants|||Number
732247|NCT00409617|Secondary|Number of Participants Who Had a Reduction in Number of Draining Fistulas of at Least 50% From Baseline to Week 20|A count of the number of cutaneous fistulas draining was performed during each physical examination. Among participants who had draining fistulas at Baseline, the number of participants who had a reduction in the number of draining fistulas of at least 50% from Baseline to Week 20 of treatment was determined. Fistulas were classified as abdominal or perianal.|Week 20 of treatment|171 participants in the ITT population (participants who received at least 1 injection of adalimumab) had draining fistulas at baseline. Data were available for 148 of the 171 participants at Week 20 of treatment. Missing values were not imputed.||Participants|||Number
732248|NCT00409617|Secondary|Number of Participants Who Were Responders at Week 20 of Treatment. A Responder Was Defined as a Participant Who Had a Decrease of 3 or More on the HBI.|5-items that assess general well-being, abdominal pain, diarrhea, abdominal mass, and complications. Score is total of 1) subject well-being (0=very well; 4=terrible); 2) abdominal pain (0=none; 3=severe); 3) diarrhea (number of time per day); 4) abdominal mass (0=none; 3=definite and tender); 5) complications (number). Participants who had a decrease from Baseline of at least 3 points in HBI total score were considered responders. Missing data were imputed using non-responder imputation (NRI).|Week 20 of treatment|"ITT Population, defined as all participants who received at least 1 injection of adalimumab. Missing data were imputed using non-responder imputation; participants who discontinued the study prior to Week 20 and participants with no score on the Harvey-Bradshaw Index (missing value) at Week 20 were counted as no for response."||Participants|||Number
732249|NCT00409617|Primary|Number of Participants in Clinical Remission at Treatment Week 20. Clinical Remission Defined as Harvey Bradshaw Index (HBI) Score Less Than 5.|5-items that assess general well-being, abdominal pain, diarrhea, abdominal mass, and complications. Score is total of 1) subject well-being (0=very well; 4=terrible); 2) abdominal pain (0=none; 3=severe); 3) diarrhea (number of time per day); 4) abdominal mass (0=none; 3=definite and tender); 5) complications (number). Maximum total score for HBI is not specified, is dependent on number of diarrhea times each day and number of complications. Clinical remission = HBI less than 5. Highest total score at Baseline was 47. Missing data were imputed using non-responder imputation (NRI).|Week 20 of treatment|"Intent-to-treat (ITT) population, defined as all participants who received at least 1 injection of adalimumab. Missing data were imputed using non-responder imputation; participants who discontinued the study prior to Week 20 and participants with no score on the Harvey-Bradshaw Index (missing value) at Week 20 were counted as no for remission."||Participants|||Number
732250|NCT00409682|Secondary|Change From Baseline IMPACT III Scores at Week 52 (Observed Case)|The IMPACT III questionnaire is a 35-item assessment of health-related quality of life in patients with inflammatory bowel disease (Crohn's disease [CD] or ulcerative colitis). In this study, subjects greater than or equal 10 years old who had CD at baseline completed an IMPACT III questionnaire at Baseline, Week 26, and Week 52. Subjects marked an option from 1 to 5 for each item left to right with numbers 5 (good 'quality of life' condition) through 1 (bad 'quality of life' condition). The total scores, range from 35 to 175 with higher scores representing a better quality of life.|Baseline and Week 52|Intent-to-treat (ITT) population for observed case (OC).||Scores on a scale||Standard Deviation|Mean
732251|NCT00409682|Secondary|Change From Baseline IMPACT III Scores at Week 26 (Observed Case)|The IMPACT III questionnaire is a 35-item assessment of health-related quality of life in patients with inflammatory bowel disease (Crohn's disease [CD] or ulcerative colitis). In this study, subjects greater than or equal 10 years old who had CD at baseline completed an IMPACT III questionnaire at Baseline, Week 26, and Week 52. Subjects marked an option from 1 to 5 for each item left to right with numbers 5 (good 'quality of life' condition) through 1 (bad 'quality of life' condition). The total scores, range from 35 to 175 with higher scores representing a better quality of life.|Baseline and Week 26|Intent-to-treat (ITT) population for observed case (OC).||Scores on a scale||Standard Deviation|Mean
732252|NCT00409682|Secondary|Percent of Participants With Clinical Response as Defined by Pediatric Crohn's Disease Activity Index (PCDAI) Score at Week 52|Pediatric Crohn's Disease Activity Index (PCDAI) is an index used to measure disease activity of pediatric patients with Crohn's Disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, examination of abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. Clinical response was defined as a decrease from Baseline in the PCDAI score of at least 15 points. The comparison was High-Dose adalimumab versus Low-Dose in the ITT population.|Week 52|Intent-to-treat population using non-responder imputation (NRI) method.||percent of participants|||Number
732253|NCT00409682|Secondary|Percent of Participants With Clinical Response as Defined by Pediatric Crohn's Disease Activity Index (PCDAI) Score at Week 26|Pediatric Crohn's Disease Activity Index (PCDAI) is an index used to measure disease activity of pediatric patients with Crohn's Disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, examination of abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. Clinical response was defined as a decrease from Baseline in the PCDAI score of at least 15 points. The comparison was High-Dose adalimumab versus Low-Dose in the ITT population.|Week 26|Intent-to-treat population using non-responder imputation (NRI) method.||percent of participants|||Number
732254|NCT00409682|Secondary|Percent of Participants With Clinical Remission as Defined by Pediatric Crohn's Disease Activity Index (PCDAI) Score ≤ 10 at Week 52|"Pediatric Crohn's Disease Activity Index (PCDAI) is an index used to measure disease activity of pediatric patients with Crohn's Disease assessing abdominal pain, stool frequency, patient functioning, hematocrit erythrocyte sedimentation rate, albumin, weight, height, examination of abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100 with higher scores indicating more active disease. Clinical remission was defined as PCDAI score of ≤ 10.
The comparison was between High-Dose adalimumab versus Low-Dose adalimumab in the intent-to treat population."|Week 52|Intent-to-treat population using non-responder imputation method.||percent of participants|||Number
732255|NCT00409682|Primary|Percent of Participants With Clinical Remission as Defined by Pediatric Crohn's Disease Activity Index (PCDAI) Score ≤ 10 at Week 26|Pediatric Crohn's Disease Activity Index (PCDAI) is an index used to measure disease activity of pediatric patients with Crohn's Disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. The primary endpoint was clinical remission as defined by PCDAI score ≤ 10. The comparison was between High-Dose adalimumab versus Low-Dose adalimumab in the intent-to-treat population.|Week 26|Comparison of adalimumab High-Dose versus Low-Dose with respect to the primary efficacy endpoint in the intent-to-treat analysis set as all randomized subjects who received at least one dose of double-blind study medication.||percent of participants|||Number
732256|NCT00409708|Primary|The Number of Micronuclei Per 1000 Binucleated Cells Endpoints at Baseline and at the End of Treatment i.e Day 84 (Week 12)|The number of micronuclei per 1000 binucleated cells was measured at Baseline ( n=34 , n=29 ) and at the end of treatment, Week 12 (n =34, n= 29), in blood cultured for 48 hours using a standard protocol.|baseline and at end of treatment (Week 12)|||number of micronuclei per 1000 binucleat||Standard Deviation|Mean
732257|NCT00409708|Secondary|Change From Baseline to the End of Treatment (Week 12) on the Severity of Illness Rating of the Clinical Global Impression Scale (CGI-S)|The Clinical Global Impression scale (CGI-S) is a clinician-rated instrument designed to assess the severity of illness. The CGI-S rating indicates illness severity at each time-point on a scale as follows: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = extremely ill. CGI-S assessments are relative to the patient’s status at the Baseline visit.|From baseline to the end of treatment (Week 12)|Per-Protocol-2 (PP2) Population: The PP2 population consisted of all subjects who were randomized and provided at least one post-baseline efficacy assessment.||Units on a rating scale||Standard Deviation|Mean
732258|NCT00409708|Secondary|Change From Baseline to the End of Treatment (Week 12) on the Global Improvement Rating of the Clinical Global Impression Scale (CGI-I)|The Clinical Global Impression scale (CGI-I) is a clinician-rated instrument designed to assess the overall change of illness relative to baseline. The CGI-I consists of 7 ratings as follows: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. CGI-I assessments are relative to the patient’s status at the Baseline visit.|From baseline to the end of treatment (Week 12)|Per-Protocol-2 (PP2) Population: The PP2 population consisted of all subjects who were randomized and provided at least one post-baseline efficacy assessment.||Units on a rating scale||Standard Deviation|Mean
732259|NCT00409708|Secondary|Change From Baseline to End of Treatment (Week 12) on the Conners' ADHD/DSM-IV Scale for Parents (CADS-P)|"Parents completed the Conners' ADHD/DSM-IV Scale for Parents (CADS-P) consisting of the ADHD Index (12 items) and the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)( 18 items). Parents rated their child's behavior of the previous week from a list of common problems. When asked How much of a problem has this been in the last week?” parents selected 0 = none, not at all, seldom, or very infrequently; 3 = very much true, or it occurs very often or frequently; or 1 or 2 for ratings in between. A score of 50 is considered normal and more than 70 markedly atypical."|Baseline to end of treatment (Week 12)|Per-Protocol-2 (PP2) Population: The PP2 population consisted of all subjects who were randomized and provided at least one post-baseline efficacy assessment.||Units on a rating scale||Standard Deviation|Mean
732260|NCT00409708|Secondary|Pharmacokinetic/Pharmacodynamic Relationship of Methylphenidate Blood Levels and Cytogenetic Changes|Since no cytogenetic effects were observed, blood samples were not analyzed for pharmacokinetics/pharmacodynamics.|End of treatment (Week 12)|||Number|||Number
732261|NCT00409708|Secondary|Number of Sister Chromatoid Exchanges Per Cell|Blood collected at baseline (n=20, n=14) and at the end of treatment, Week 12, (n= 20, n= 14) was cultured for 48 hours using a standard protocol. Giemsa staining and/or fluorescent in situ hybridization (FISH) chromosome painting was done on the cells in metaphase and the number of chromatoid exchanges per cell was recorded by blinded raters.|baseline and at end of treatment (Week 12)|Per-Protocol-2 population: The PP2 population consisted of all subjects who were randomized and provided at least one post-baseline efficacy assessment.||number of sister chromatoid exchanges||Standard Deviation|Mean
732262|NCT00409708|Primary|The Number of Chromosomal Aberrations Per 100 Cells Excluding Gaps at Baseline and at the End of Treatment i.e Day 84 (Week 12)|The number of chromosomal aberrations per 100 cells excluding gaps at Baseline (n=33, n=32) and at Week 12 (n=33, n=32) was counted in blood samples cultured for 48 hours using a standard protocol. The types of abnormalities included translocations (reciprocal and non-reciprocal), insertions, dicentrics, fragments, inversions, chromatid exchanges (quadriradials and triradials), breaks, and other unusual observations, eg, aneuploidy, tetraploidy or endoreduplication.|baseline and at end of treatment (Week 12)|Per-Protocol-1 (PP1) population: The PP1 population consisted of all patients who were randomized and provided cytogenetic data for at least one of the primary endpoints at baseline and at the Week 12 evaluation.||number of abnormalities||Standard Deviation|Mean
732263|NCT00409747|Secondary|Clinical Global Impressions Scale-Severity (CGI). (Connors & Barkley, 1985)|This instrument has two scales – Severity (CGI-S). The CGI-S is a seven point scale with a minimum score of 1 and a maximum score as 7 as follows: 1 = normal, not at all ill; 2 = borderline ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill patients.|Baseline and 6 months|All children completing 6 months of drug and participating in final evaluation||mean scores on global impression scale||Standard Deviation|Mean
732264|NCT00409747|Primary|z Score|"The Mann–Whitney U-test was used to compare pre-/post-treatment differences in analyte concentrations in serum, plasma and CSF. The Mann-Whitney U test generates a z-score test statistic with an associated p value. A negative z-statistic reflects a decrease in analyte level from pre- to post-treatment. Statistical significance level was set at 0.05. There is one test statistic (z-score) per analyte, reflecting the pre-post comparison across all subjects.
Pre and post treatment measurements of csf analytes: TNF alpha, Il-6, CCL-2(MCP-1), CCL3 (MIP-1alpha), CCL5(RANTES), CXCL(IL-8), BDNF, CD40L, GDNF, HGF, Leptin"|Pre and post treatment with minocyline at 6 months for 10 subjects|10 subjects completed six months of minocycline and have pre-/post-minocycline CSF samples for analysis.||Z-score|||Number
732265|NCT00409773|Secondary|Percent Change From Baseline in High-Sensitivity C-reactive (Hs-CRP) (mg/dL) at Week 6||Baseline and 6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Median
732266|NCT00409773|Secondary|Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 6 in Patients Without Atherosclerotic Vascular Disease (AVD)||Baseline and 6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
732267|NCT00409773|Secondary|Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 6 in Patients With Atherosclerotic Vascular Disease (AVD)||Baseline and 6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
732268|NCT00409773|Secondary|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol: High Density Lipoprotein Cholesterol (Non-HDL-C:HDL-C) at Week 6||Baseline and 6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
732269|NCT00409773|Secondary|Percent Change From Baseline in Apolipoprotein-B: Apolipoprotein-A1 (Apo-B:Apo-A1) at Week 6||Baseline and 6 weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
732270|NCT00409773|Secondary|Percent Change From Baseline in Low Density Lipoprotein Cholesterol: High Density Lipoprotein Cholesterol (LDL-C: HDL-C) at Week 6||Baseline and 6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
732271|NCT00409773|Secondary|Percent Change From Baseline in Total-Cholesterol: High Density Lipoprotein-Cholesterol (Total-C:HDL- C) at Week 6||Baseline and 6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
732272|NCT00409773|Secondary|Percent Change From Baseline in Apolipoprotein-A1 (Apo-A1) at Week 6||Baseline and 6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
732273|NCT00409773|Secondary|Percent Change From Baseline in Apolipoprotein- B (Apo-B) at Week 6||Baseline and 6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
732274|NCT00409773|Secondary|Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 6||Baseline and 6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
732275|NCT00409773|Secondary|Percent Change From Baseline in Non- High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6||Baseline and 6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
732391|NCT00410202|Secondary|Percentage of Participants With Confirmed HBeAg Loss at Week 96 (Treated HBeAg Positive Participants Only)|HBeAg is a hepatitis B viral protein. HBeAg loss = HBeAg-negative at the specified analysis week|Week 96|Participants who received at least 1 dose of study therapy and were HBeAG positive. Participants with missing efficacy assessments were considered as a failure.||percentage of participants|||Number
732276|NCT00409773|Secondary|Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 6||Baseline and 6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
732277|NCT00409773|Secondary|Percent Change From Baseline in Triglyceride (TG) (mg/dL) at Week 6||Baseline and 6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Median
732278|NCT00409773|Secondary|Percent Change From Baseline in Total Cholesterol(mg/dL) at Week 6||Baseline and 6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
732279|NCT00409773|Primary|Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 6||Baseline and 6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
732280|NCT00409786|Secondary|Physical Activity||1 year||||||
732281|NCT00409786|Secondary|Health Related Quality of Life||1 year||||||
732282|NCT00409786|Secondary|Fat Consumption||1 year||||||
732283|NCT00409786|Secondary|A1C (if Applicable)||1 year||||||
732284|NCT00409786|Secondary|Lipid||1 year||||||
732285|NCT00409786|Secondary|Blood Pressure||1 year||||||
732286|NCT00409786|Primary|Change in Weight||Baseline and 1 year|Of the original 50 participants, 12 month data was collected for 45 (90%) of them. Analysis was conducted on those participants with 12 month data.||kg||95% Confidence Interval|Mean
732287|NCT00409825|Primary|Change in the Area Under the Concentration vs. Time Curve in the Second and Third Trimesters of Pregnancy.|"Change in the area under the concentration vs. time curve in the second and third trimesters of pregnancy.
We compared AUC at each PK study visit. Measurements were obtained at 0, 1, 2, 3, 4, 5, 6, 7 days."|Second and third trimesters of pregnancy|||ng/ML/day||Standard Deviation|Mean
732288|NCT00409838|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate||Days 169 to 1569|Participants who completed the Short-term Period. n=Number of evaluable participants.||mm/h||Standard Error|Mean
732289|NCT00409838|Secondary|Change From Baseline in Levels of C-reactive Protein (CRP)||Days 169 to 1569|Participants who completed the Short-term Period. n=Number of evaluable participants.||mg/dL||Standard Error|Mean
732290|NCT00409838|Secondary|Percentage of Participants With Low Disease Activity Score (LDAS) or Who Are in Remission|LDAS is defined as a Disease Activity Score C-reactive protein (DAS28-CRP) level <=3.2. Remission is defined as a DAS28-CRP level <2.6.|At Days 169, 337, 729, 1149, and 1485|All participants who finished the Short-term period. n=Number of evaluable participants||Percentage of participants||95% Confidence Interval|Number
732291|NCT00409838|Secondary|Changes From Baseline in the Simplified Disease Activity Index (SDAI) and the Clinical Disease Activity Index (CDAI) Scores|The SDAI is the sum of 5 parameters: Tender joint (TJC) and swollen joint(SJC)counts, based on a 28-joint assessment; patient global (PtGA)and physician global assessments (PGA), assessed on 0-10 cm visual analog scale (VAS), on which higher scores=greater affection due to disease activity DA); and C-reactive protein level. SDAI total score=0-86. SDAI <=3.3 indicates disease remission, >3.4 to 11=low DA, >11 to 26=moderate DA, and >26=high DA. SJC is assessed at each visit, with no swelling=0, swelling=1. TJC is assessed through identification of joints painful under pressure or to passive motion at each visit, with no tenderness=0, tenderness=1. Higher score=greater affection due to DA. CDAI is sum of 4 parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PGA (assessed on 0-10 cm VAS; higher scores=greater affection due to disease activity). CDAI total score=0-76. CDAI <=2.8 indicates disease remission, >2.8 to 10=low DA, >10 to 22=moderate DA, and >22=high DA.|At Days 169 and 1569|All participants who received study drug and who were evaluable||Units on a scale||95% Confidence Interval|Mean
732292|NCT00409838|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR)-Defined Low Disease Activity Score (LDAS) and With EULAR-defined Remission|EULAR defines LDAS as a disease activity score as measured by c-reactive protein (DAS28-CRP) ≤3.2 and remission as DAS28-CRP <2.6|At Days 169 and 1485|All participants who received study drug and who were evaluable||Percentage of participants|||Number
732293|NCT00409838|Secondary|Changes From Baseline in Short-Form 36 (SF-36) Physical and Mental Health Summaries|The SF-36 is a 36-item questionnaire used to measure Quality of Life over 8 physically and emotionally based areas: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. Answers to each question correspond to a precoded numeric value. An aggregate percentage score is reached for each of the 8 sections and is based on answers to questions. The mean average is worked out for each section. Scores range from 0% (lowest level of functioning) to 100% (highest level of functioning, with higher score indicated increasing levels of functioning.|At Day 1485|All participants who received study drug and who were evaluable||Units on a scale||Standard Error|Mean
732294|NCT00409838|Secondary|Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score|The HAQ-DI assesses a patient's level of functional ability via 20 questions in 8 categories of functioning. Patients respond on a scale from 0 (no disability) to 3 (completely disabled); total possible score=24. Higher score indicates greater disability. Change from baseline= postbaseline - baseline value.|Day 1485|All participants who received study drug and who were evaluable||Units on a scale||Standard Error|Mean
732392|NCT00410202|Secondary|Percentage of Participants With Confirmed HBeAg Loss at Week 48 (Treated HBeAg Positive Participants Only)|HBeAg is a hepatitis B viral protein. HBeAg loss = HBeAg-negative at the specified analysis week|Week 48|Participants who received at least 1 dose of study therapy and were HBeAG positive. Participants with missing efficacy assessments were considered as a failure.||percentage of participants|||Number
732295|NCT00409838|Secondary|Percentage of Participants With Physical Function Response as Assessed Using the Health Assessment Questionnaire Disability Index (HAQ-DI)|Improvement is measured by an improved response of at least 0.3 units from baseline on the HAQ-DI score. The HAQ-DI assesses a patient's level of functional ability via 20 questions in 8 categories of functioning. Patients respond on a scale from 0 (no disability) to 3 (completely disabled); total possible score=24. Higher score indicates greater disability. Change from baseline= postbaseline - baseline value.|At Day 1485|All participants who received study drug and who were evaluable||Percentage of participants|||Number
732296|NCT00409838|Secondary|Percentage of Participants Achieving ACR20, ACR50, and ACR70 Over Time|The ACR 20, ACR50, and ACR70 are based on 20%, 50% and 70% improvement, respectively, (compared with baseline values) in tender and swollen joint counts and on 20%, 50% and 70%, respectively, improvement in 3 of the remaining 5 core set measures (participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function) and 1 acute phase reactant value.|Days 15 through 1569|All participants who completed the ST period and received at least 1 infusion of abatacept during the LTE period. n=evaluable participants at that timepoint for that measure.||Percentage of participants||95% Confidence Interval|Number
732297|NCT00409838|Secondary|LTE Period: Overall Number of Participants With Positive Results of Immunogenicity Samples|Positive antibody titers were identified by validated enzyme-linked immunosorbent assay results. On-treatment samples were obtained during the LTE period, and posttreatment samples were following the last infusion of study medication.|Days 169, at 6-month intervals on-treatment, and at Days 28, 56, and 85 after the last infusion of study medication in the LTE period|All participants who during the LTE period, received at least 1 infusion of abatacept and had at least 1 immunogenicity sample collected.||Participants|||Number
732298|NCT00409838|Primary|Long-term Extension (LTE) (Open-Label) Period: Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Related SAEs, Discontinuatons Due to SAEs, Adverse Events (AEs), Related AEs, and Discontinuations Due to AEs|AE=any new untoward medical occurrence or worsening of a preexisting medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|Day 169 to up to 56 days post the last dose (Day 1485) in the LTE period|All participants who completed the short-term period and received at least 1 infusion of abatacept during the LTE period||Participants|||Number
732299|NCT00409838|Secondary|Change From Baseline in Surrogate Marker Rheumatoid Factor (RF) at Day 169|Mean change in RF. A surrogate marker is an indirect measurement of effectiveness. Mean change from Baseline = postbaseline - baseline value.|Baseline, Day 169|All Randomized and Treated Participants. The summary was based on the last observation carried forward (LOCF) procedure. Participants with baseline and post-baseline measurements were included, not the participants who had only baseline measurements.||IU/mL||Standard Error|Mean
732300|NCT00409838|Secondary|Change From Baseline in Surrogate Marker Erythrocyte Sedimentation Rate (ESR) at Day 169|Mean change in surrogate marker mean ESR. A surrogate marker is an indirect measurement of effectiveness. Change from Baseline = postbaseline - baseline value.|From Baseline to Day 169|All randomized participants who received study drug. Participants with baseline and post-baseline measurements were included, not the participants who had only baseline measurements.||mm/h||Standard Error|Mean
732301|NCT00409838|Secondary|Immunogenicity of Abatacept- Number of Participants With Reactivity Toward CTLA4-IG and CTLA4-T at Day 169|Immunogenicity was determined by measuring adult subject sera for reactivity against the whole Abatacept molecule (CTLA4Ig) and CTLA4-T (CTLA4 without the Ig regions).|Day 169|All participants who received study drug (abatacept)||participants|||Number
732302|NCT00409838|Secondary|Summary Statistics of Minimum Observed Serum Concentration (Cmin) for Abatacept|Minimum concentration (Cmin) of Abatacept 500 mg and 750 mg at given time points|At the end of infusion and 2 to 4 hours after the start of the infusion on Day 85|Participants with measurement at timepoint||μg/mL||Standard Deviation|Mean
732303|NCT00409838|Secondary|Abatacept Pharmacokinetic (PK) Parameters: Volume at Steady State (VSS)|The volume of distribution of drug at steady state (VSS). Steady-state PK parameters following administration of body-weight tiered doses approximating 10 mg/kg.|At the end of infusion, 2 to 4 hours after the start of infusion on Day 85, anytime between Day 92 and 96, and predose on Day 113|Participants with measurement at stated dose level||L/kg||Standard Deviation|Mean
732304|NCT00409838|Secondary|Abatacept Pharmacokinetic (PK) Parameters: Total Body Clearance (CLT)|Steady-state PK parameters following administration of body-weight tiered doses approximating 10 mg/kg. Clearance is a pharmacokinetic parameter that describes how quickly drugs are eliminated, metabolized or distributed throughout the body.|Day 29, every 28 days until Day 141|Participants with measurement at stated dose level||mL/h/kg||Standard Deviation|Mean
732305|NCT00409838|Secondary|Abatacept Pharmacokinetic (PK) Parameters - Area Under the Curve (AUC)|Area Under the Plasma Concentration-Time Curve (AUC), a measure of drug absorption, in a dosing interval of 28 days from Day 85 to Day 113. Steady-state PK parameters following administration of body-weight tiered doses approximating 10 mg/kg.|At the end of infusion, 2 to 4 hours after the start of infusion on Day 85, anytime between Day 92 and 96, and predose on Day 113|Participants with measurement at stated dose level||μg.h/mL||Standard Deviation|Mean
732306|NCT00409838|Secondary|Abatacept Pharmacokinetic (PK) Parameters - Maximum Concentration (Cmax)|Steady-state PK parameters following administration of body-weight tiered doses approximating 10 mg/kg. Maximum Concentration (Cmax)= the maximum plasma concentration of the drug.|At the end of infusion and 2 to 4 hours after the start of the infusion on Day 85, at anytime between Day 92 and 96, and pre-dose on Day 113|Participants with measurement at stated dose level||μg/mL||Standard Deviation|Mean
732393|NCT00410202|Secondary|Percentage of Participants With Alanine Aminotransferase (ALT) > 1 x Upper Limit of Normal (ULN) at Baseline Who Achieve ALT Normalization at Week 96|ALT normalization=ALT level being less than or equal to 1 times the upper limit of normal (ULN). ULN for ALT is 37 U/L.|Baseline, Week 96|Participants who received at least 1 dose of study therapy and had ALT > 1 x ULN at baseline (day 1) were analyzed. Participants with missing efficacy assessments were considered as a failure.||percentage of participants|||Number
732307|NCT00409838|Secondary|Abatacept Pharmacokinetic (PK) Parameters: Time to Maximum Concentration (Tmax) and Half-Life of Elimination (T-Half)|Steady-state PK parameters following administration of body-weight tiered doses approximating 10 mg/kg. Tmax = the time after administration of a drug when the maximum plasma concentration is reached; when the rate of absorption equals the rate of elimination. T-Half = the biological half-life or elimination half life of a substance is the time it takes for a substance to lose half of its pharmacologic, physiologic, or radiologic activity.|At the end of infusion and 2 to 4 hours after the start of infusion on Day 85, at anytime between Day 92 and 96, and pre-dose on Day 113|Participants with measurement at stated dose level||Hours||Standard Deviation|Mean
732308|NCT00409838|Secondary|Percentage of Participants Experiencing Deaths, Serious Adverse Events (SAEs), Adverse Events (AEs), Related SAEs and AEs, and Discontinuations Due to SAEs and AEs During the Double-Blind Period|AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|Throughout double-blind study period (up to Day 169); table includes data up to 56 days past double-blind period or start of the open-label period, whichever occurred first.|All randomized participants who received study drug.||Percentage of participants|||Number
732309|NCT00409838|Secondary|Change From Baseline to Day 169 in Analysis of Short-Form 36 (SF-36) Health Survey Questionnaire Domains|Adjusted mean change from baseline. The SF-36 is a 36-item self-administered questionnaire developed to assess health-related quality of life and comprised of 8 domains( including 4 physical and 4 mental subscales) used to derive the physical and mental component summary scores. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Change from baseline=postbaseline - baseline value.|From Baseline to Day 169|All randomized participants who received study drug and were evaluable.||Units on a scale||Standard Error|Mean
732310|NCT00409838|Secondary|Change From Baseline to Day 169 in Health Assessment Questionnaire Disability Index (HAQ-DI) Score|Adjusted mean change from baseline. The HAQ-DI assesses a patient's level of functional ability via 20 questions in 8 categories of functioning. Patients respond on a scale from 0 (no disability) to 3 (completely disabled); total possible score=24. Higher score indicates greater disability. Change from baseline= postbaseline - baseline value.|From Baseline to Day 169|All randomized participants who received study drug||Units on a scale||Standard Error|Mean
732311|NCT00409838|Secondary|Change From Baseline in Disease Activity Scores (DAS) Based on C-reactive Protein (DAS 28 [CRP]) Levels or Erythrocyte Sedimentation Rate (DAS 28[ESR])|Adjusted mean change from baseline. The DAS28 provides a score on a scale from 0 to 10 indicating the current activity of rheumatoid arthritis (>5.1=high disease activity; <3.2=low disease activity; <2.6=remission). CRP or ESR give estimations of DAS28 values on a group level. Change from Baseline=Postbaseline - Baseline value.|From Baseline to Days 169 and 1485|All randomized participants who received study drug and who were evaluable.||Units on a scale||Standard Error|Mean
732312|NCT00409838|Secondary|Percentage of Participants With at Least 20%, 50%, or 70% Improvement From Baseline in American College of Rheumatology (ACR) Core Components|The ACR defines improvement in core components as 20%, 50%, or 70% improvement in tender and swollen joint counts and 3 of the remaining core components: patient global assessment of disease activity, physician global assessment of disease activity, patient assessment of pain, patient self-assessed disability (Health Assessment Questionnaire Disability Index [HAQ-DI]), and levels of 1 acute phase reactant (C-reactive protein levels or erythrocyte sedimentation rate.) The HAQ-DI assesses a patient's level of functional ability via 20 questions in 8 categories of functioning; scale=0 (no disability) to 3 (completely disabled); total possible score=24. The higher the score, the greater the disability.|From Baseline to Day 169|All randomized participants who received study drug and who were evaluable.||Percentage of participants|||Number
732313|NCT00409838|Secondary|Percentage of Participants With American College of Rheumatology (ACR) ACR50 and ACR70 Response at Day 169|The ACR defines ACR 50 and ACR70 response as a 50% or 70% improvement (compared with baseline values) in tender and swollen joint counts and 50% or 70% improvement in 3 of the remaining 5 core set measures (patient global assessment of pain, patient global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function) and 1 acute phase reactant value (C-reactive protein).|At Day 169|All randomized participants who received study drug.||Percentage of participants|||Number
732314|NCT00409838|Primary|Percentage of Participants Meeting the Criteria of the American College of Rheumatology for 20% Improvement (ACR20)|The ACR 20 is based on 20% improvement (compared with baseline values) in tender and swollen joint counts and on 20% improvement in 3 of the remaining 5 core set measures (participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function) and 1 acute phase reactant value.|At Day 169|All randomized participants who received study drug.||percentage of participants|||Number
732315|NCT00410046|Secondary|Change From Baseline Haywood Quality of Life Score From Baseline to Week 38|Haywood quality of life instrument was utilized in the United Kingdom as the ASQoL measure. The ASQoL is an AS-specific measure of QoL, scores range from 0 (good QoL) to 80 (poor QoL). ASQoL is intended to measure the quality of life by means of questions about mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Patient's 0881A3-402 baseline score was used in the analysis. Change=baseline-week 38.|Baseline and 38 weeks|All patients from United Kingdom sites who completed study 0881A3-402 (NCT00247962), continued into this study, received at least 1 dose of study drug had at least 1 post-baseline assessment and completed 38 weeks.||units on scale||Standard Deviation|Mean
732350|NCT00410124|Secondary|Pharmacokinetics of RAD001: Time at Which C-Max Occurs (t-Max)|Blood samples will be collected by direct venipuncture during regularly scheduled visits according to the collection plan provided in the study protocol.|At pre-dose and post-dose: 1 hour, 2 hour, 5 hour, 24 hour of Cycle 1 Day 1, Cycle 1 Day 15 and at pre-dose of From Cycle 2 (Day 1) and all subsequent treatment cycles until data cut-off 28Feb2008.|The pharmacokinetics population consists of all patients who have a pharmacokinetic assessment with a sufficient number of evaluable blood samples. The analsyis was limited to RAD001 + BSC arm.||h||Full Range|Median
732316|NCT00410046|Secondary|Change in Baseline Ankylosing Spondylitis Quality of Life (ASQoL) Score From Baseline to Week 38|ASQoL is a questionnaire that assesses disease-specific quality of life (QoL). It consists of 18 statements that are relevant to the physical and mental conditions for a patient with Ankylosing Spondylitis (AS): mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each statement is answered by the patient as a ‘Yes’ (scored as 1) or ‘No’ (scored as 0). All item scores are summed to give a total score. Total score can range from 0 (good QoL) to 18 (poor QoL). The 0881A3-402 baseline score was used as the baseline for this analysis. Change = baseline - week 38.|Baseline and 38 weeks|All patients who completed study 0881A3-402 (NCT00247962), continued into this study, received at least 1 dose of study drug, had at least 1 post-baseline assessment, and completed 38 weeks.||units on scale||Standard Deviation|Mean
732317|NCT00410046|Secondary|Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score for Fatigue From Baseline to Week 38|BASDAI is a validated self assessment tool used to determine disease activity in patients with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) patient's answered 6 questions measuring discomfort, pain and fatigue. The fatigue-specific score is presented here. The 0881A3-402 (NCT00247962) baseline score was used as the baseline for this analysis. Change = baseline - week 38.|Baseline and 38 weeks|All patients who completed study 0881A3-402 (NCT00247962), continued into this study, received at least 1 dose of study drug and had at least 1 post-baseline assessment.||units on scale||Standard Deviation|Mean
732318|NCT00410046|Secondary|Change in Bath Ankylosing Spondylitis Metrology Index (BASMI) Score From Baseline to Weeks 38|BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10. The 0881A3-402 (NCT00247962) baseline score was used as the baseline for this analysis. Change = baseline - week 38.|Baseline and 38 weeks|All patients who completed study 0881A3-402 (NCT00247962), continued into this study, received at least 1 dose of study drug and had at least 1 post-baseline assessment.||units on scale||Standard Deviation|Mean
732319|NCT00410046|Primary|Number of Patients Taking Sick Leave in the 48 Weeks Before and During Treatment|Patients were asked whether or not they had taken sick leave during the 48 weeks preceding enrollment in study 0881A3-402 (NCT00247962) and during the 48 weeks of treatment in this extension study (0881A3-405).|96 weeks|All patients who completed study 0881A3-402 (NCT00247962), continued into this study, received at least 1 dose of study drug and had at least 1 post-baseline assessment.||patients|||Number
732320|NCT00410046|Primary|Number of Patients Using Healthcare Resources in the 48 Weeks Before and During Treatment|Healthcare resources were defined as hospital admissions, therapeutic warm baths, physiotherapist visits, and outpatient physician visits. Healthcare resource utilization was evaluated using a questionnaire asking patients whether or not they had used the healthcare resource during the 48 weeks preceding enrollment in study 0881A3-402 (NCT00247962) and during the 48 weeks of treatment in this extension study (0881A3-405).|96 weeks|All patients who took ETN and completed study 0881A3-402 (NCT00247962), continued into this study, received at least 1 dose of study drug and had at least 1 post-baseline assessment.||patients|||Number
732321|NCT00410046|Secondary|Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score From Baseline to Week 38|BASDAI is a validated self assessment tool used to determine disease activity in patients with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) patient's answered 6 questions measuring discomfort, pain and fatigue. The final BASDAI score averages the individual assessments for a final score range of 0-10. The 0881A3-402 (NCT00247962) baseline score was used as the baseline for this analysis. Change = baseline - week 38.|Baseline and 38 weeks|All patients who received at least 1 dose of study drug and had at least 1 post-baseline assessment.||units on scale||Standard Deviation|Mean
732322|NCT00410046|Secondary|Change in Bath Ankylosing Spondylitis Functional Index (BASFI) Score From Baseline to Week 38|BASFI is a validated self assessment tool that determines the degree of functional limitation in Ankylosing Spodylitis (AS) patients. Utilizing a VAS of 0-10 (0=easy, 10=impossible), patients answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions, with a maximum score of 100 mm. The 0881A3-402 (NCT00247962) baseline score was used as the baseline for this analysis. Change = baseline - week 38.|Baseline and 38 weeks|All patients who completed study 0881A3-402 (NCT00247962), continued into this study, received at least 1 dose of study drug and had at least 1 post-baseline assessment.||units on scale||Standard Deviation|Mean
732323|NCT00410046|Secondary|Change in Total Back Pain Score From Baseline to Week 38|Total Back Pain was measured on a 0 to 100 mm VAS, with 0 mm indicating no pain. The 0881A3-402 (NCT00247962) baseline score was used as the baseline for this analysis. Change = baseline - week 38.|Baseline and 38 weeks|All patients who completed study 0881A3-402 (NCT00247962), continued into this study, received at least 1 dose of study drug and had at least 1 post-baseline assessment.||units on scale||Standard Deviation|Mean
732324|NCT00410046|Secondary|Change in Patient Global Assessment of Disease Activity From Baseline to Week 38|Patient Global Assessment of Disease Activity was measured on a 0 to 100 mm Visual Analog Scale (VAS), with 0 mm = no disease activity. The 0881A3-402 (NCT00247962) baseline score was used as the baseline for this analysis. Change = baseline - week 38.|Baseline and 38 weeks|All patients who completed study 0881A3-402 (NCT00247962), continued into this study, received at least 1 dose of study drug and had at least 1 post-baseline assessment||units on scale||Standard Deviation|Mean
732325|NCT00410046|Secondary|Number of Sick Days Per Patient During the 48 Weeks of Treatment|Patients were asked whether or not they had taken sick leave during the 48 weeks of treatment, and if so, how many days. The mean number of days is based on those patients who had sick leave during the treatment period.|48 weeks|All patients who completed study 0881A3-402 (NCT00247962), continued into this study, received at least 1 dose of study drug and had at least 1 post-baseline assessment.||Sick days per patient||Full Range|Mean
732326|NCT00410046|Secondary|Number of Patients With Sick Leave During 48 Weeks Treatment|The impact of treatment on work productivity was assessed by sick leave. Patients were asked whether or not they had taken sick leave during the 48 weeks of treatment, and if so, how many days.|48 weeks|All patients who completed study 0881A3-402 (NCT00247962), continued into this study, received at least 1 dose of study drug and had at least 1 post-baseline assessment.||patients|||Number
736587|NCT00443040|Secondary|Time to First Bowel Movement||Daily for 38 days||||||
732327|NCT00410046|Secondary|Number of Times Healthcare Resources Were Used Per Patient During 48 Weeks of Treatment|Healthcare resources were defined as hospital admissions, therapeutic warm baths, physiotherapist visits, and outpatient physician visits. Healthcare resource utilization was evaluated using a questionnaire asking all patients whether or not they had used the healthcare resource during the 48 weeks of treatment, and if so, how many times the resource was used. The mean number of times is based on those patients who responded to the questionnaire stating they had utilized healthcare resources (see outcome measure 3).|48 weeks|All patients who completed study 0881A3-402 (NCT00247962), continued into study 0881A3-405, received at least 1 dose of study drug and had at least 1 post-baseline assessment.||# of times utilized per patient||Full Range|Mean
732328|NCT00410046|Secondary|Number of Patients Utilizing Healthcare Resources During 48 Weeks of Treatment|Healthcare resources were defined as hospital admissions, therapeutic warm baths, physiotherapist visits, and outpatient physician visits. Healthcare resource utilization was evaluated using a questionnaire asking patients whether or not they had used the healthcare resource during the 48 weeks of treatment.|48 weeks|All patients who completed study 0881A3-402 (NCT00247962), continued into this study, received at least 1 dose of study drug and had at least 1 post-baseline assessment.||patients|||Number
732329|NCT00410059|Primary|8 Week Progression-Free Survival Rate (i.e. Disease Control Rate)|Progression-free survival (i.e. disease control rate) defined as percentage of participants without progression at 8 weeks, evaluation after the second cycle of therapy (i.e., 8 weeks), with confirmation of efficacy 2 cycles after its initial assessment. A “success” or “disease control” to treatment is defined as a participant being progression free at 8 weeks after randomization.|Radiographic evaluation after cycle 2 (8 weeks of therapy)|One participant was not evaluable for outcome.||Participants|||Count of Participants
732330|NCT00410072|Secondary|Number of Participants With Virologic Breakthrough at Week 96|ETVr=entecavir resistance; TFDr=tenofovir resistance. Virologic breakthrough=confirmed >=1 log10 increase in HBV DNA from moving nadir|Week 96|Participants with confirmed >= 1 log10 increase in HBV DNA from moving nadir||Participants|||Number
732331|NCT00410072|Secondary|Number of Participants With Virologic Breakthrough at Week 48|ETVr=entecavir resistance; TFDr=tenofovir resistance. Virologic breakthrough= confirmed >= 1 log10 increase in HBV DNA from the on-treatment nadir|Week 48|Participants with confirmed >=1 log10 increase in HBV DNA from the on-treatment nadir||Participants|||Number
732332|NCT00410072|Secondary|Number of Participants With HBV Resistance at Week 96|ETVr=entecavir resistance; TFDr=tenofovir resistance. HBV polymerase using the Trugene® HBV Genotyping Kit. HBV resistance: genotyping of HBV polymerase will be performed on stored viral samples at any timepoint when considered appropriate based on virologic response, including any specimen with detectable HBV DNA. When appropriate, phenotyping will also be used.|Week 96|Participants who received study drug and with HBV DNA levels >=50 IU/mL.||Participants|||Number
732333|NCT00410072|Secondary|Number of Participants With HBV Resistance Through Week 48|ETVr=entecavir resistance; TDFr=tenofovir resistance. HBV polymerase using the Trugene® HBV Genotyping Kit. HBV resistance: genotyping of HBV polymerase will be performed on stored viral samples at any timepoint when considered appropriate based on virologic response, including any specimen with detectable HBV DNA. When appropriate, phenotyping will also be used.|Week 48|All participants who received study drug and with HBV DNA levels >=50 IU/mL||Participants|||Number
732334|NCT00410072|Secondary|Number of Participants With Adverse Events, Serious Adverse Events, and Discontinuations From Study Drug Due to Adverse Events or Laboratory Abnormalities|AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to any AEs were recorded.|From enrollment through Week 100 + 24-week follow-up|All treated participants.||Participants|||Number
732335|NCT00410072|Secondary|Number of Participants With HBV DNA in Relevant Categories at Weeks 48 and 96|Using the Roche COBAS TaqMan - HPS assay. Lower limit of Quantitation (LOQ) is the level above which quantitative results may be obtained with a specified degree of confidence. The LOQ is mathematically defined as equal to 10 times the standard deviation of the results for a series of replicates used to determine a justifiable limit of detection. Limits of quantitation are matrix-, method-, and analyte-specific.|At Weeks 48 and 96|All treated participants.||Percentage of participants|||Number
732336|NCT00410072|Secondary|Percentage of Participants With HBsAg Seroconversion at Weeks 48 and 96|HBsAg = a part of the hepatitis B virus that, when in the blood, is an early marker of infection.|At Weeks 48 and 96|Treated HBeAg-positive participants. If a participant was missing the efficacy assessments for a visit, this is considered a failure and was counted as evaluable.||Percentage of participants|||Number
732337|NCT00410072|Secondary|Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48 and 96|HBsAg = A part of the hepatitis B virus. When found in the blood, HBsAg is an early marker of infection. Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints.|At Weeks 48 and 96|Treated HBeAg-positive participants. If a participant was missing the efficacy assessments for a visit, this is considered a failure and was counted as evaluable.||Percent of participants|||Number
732338|NCT00410072|Secondary|Percentage of Participants With HBeAg Seroconversion [( at Weeks 48 and 96|HBeAg seroconversion=HBeAg loss and presence of hepatitis B e antibody (HBeAb). HBeAg is a hepatitis B viral protein and is an indicator of active viral replication.|At Weeks 48 and 96|Treated HBeAg-positive participants. A participant missing the efficacy assessments for a visit was considered a failure and was counted as evaluable.||Percentage of participants|||Number
732339|NCT00410072|Secondary|Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss at Weeks 48 and 96|HBeAg is a hepatitis B viral protein and is an indicator of active viral replication. Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints.|At Weeks 48 and 96|Treated HBeAg-positive participants. If a participant was missing the efficacy assessments for a visit, this is considered a failure and was counted as evaluable.||Percentage of participants|||Number
732340|NCT00410072|Secondary|Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 48 and 96|ALT normalization= ≤1*upper limit of normal (ULN). Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints.|At Weeks 48 and 96|Evaluable participants. A participant missing the efficacy assessments for a visit is considered a failure and counted as evaluable.||Percentage of participants|||Number
732341|NCT00410072|Secondary|Mean Log 10 HBV DNA at Weeks 48 and 96|HBV DNA was analyzed by PCR, using the Roche COBAS®TaqMan - HPS assay. Reduction in Log 10 HBV count=reduced viral load.|Baseline, Weeks 48 and 96|Evaluable participants at given time point. If a participant is missing the efficacy assessments for a visit, this is considered a failure and is counted as evaluable.||log10 copies/mL||Standard Error|Mean
732342|NCT00410072|Secondary|Percentage of Participants Who Achieved HBV DNA Levels <LOD by PCR at Weeks 48 and 96|LOD=Lower limit of detection. LOD) LOD=10 IU/mL, or approximately 58 copies/mL. LOD is the lowest concentration level that can be determined to be statistically different from a blank (99% confidence). The LOD is typically determined to be in the region where the signal to noise ratio is greater than 5. Limits of detection are matrix-, method-, and analyte-specific.Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints.|At Weeks 48 and 96|Evaluable participants. A participant missing the efficacy assessments for a visit is considered a failure and is counted as evaluable.||Percentage of participants|||Number
732343|NCT00410072|Secondary|Percentage of Participants Who Achieved HBV DNA Levels <LOQ by PCR at Weeks 48 and 96|LOQ=lower limit of quantitation. LOQ=29 IU/mL, or approximately 169 copies/mL. LOQ is the level above which quantitative results may be obtained with a specified degree of confidence. The LOQ is mathematically defined as equal to 10 times the standard deviation of the results for a series of replicates used to determine a justifiable limit of detection. Limits of quantitation are matrix-, method-, and analyte-specific.Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints.|At Weeks 48 and 96|Evaluable participants. A participant missing the efficacy assessments for a visit is considered a failure and is counted as evaluable.||Percentage of participants|||Number
732344|NCT00410072|Secondary|Percentage of Participants Who Achieved HBV DNA Levels <50 IU/mL by PCR at Week 48 and Week 96 by Hepatitis B e Antigen (HBeAg) Status|HBV DNA levels <50 IU/mL=approximately 300 copies/mL. Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints.|At Weeks 48 and 96|Evaluable participants. If a participant is missing the efficacy assessments for a visit, this is considered a failure and is counted as evaluable.||Percentage of participants|||Number
732345|NCT00410072|Primary|Percentage of Participants Who Achieved Hepatitis B Virus DNA (HBV DNA) Levels <50 IU/mL by Polymerase Chain Reaction (PCR) at Week 96|HBV DNA levels <50 IU/mL=approximately 300 copies/mL. Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints.|At Week 96|Evaluable participants. A participant missing the efficacy assessments for a visit is considered a failure and is counted as evaluable.||Percentage of participants|||Number
732346|NCT00410124|Secondary|Pharmacokinetics of RAD001: Normalized to Body Surface Area (CL/F)|Blood samples will be collected by direct venipuncture during regularly scheduled visits according to the collection plan provided in the study protocol.|At pre-dose and post-dose: 1 hour, 2 hour, 5 hour, 24 hour of Cycle 1 Day 1, Cycle 1 Day 15 and at pre-dose from Cycle 2 (Day 1) and all subsequent treatment cycles until data cut-off 28Feb2008.|The pharmacokinetics population consists of all patients who have a pharmacokinetic assessment with a sufficient number of evaluable blood samples. The analsyis was limited to RAD001 + BSC arm.||L/hour/m^2||Standard Deviation|Mean
732347|NCT00410124|Secondary|Pharmacokinetics of RAD001: Apparent Systemic Clearance From Blood Following Extravascular Administration (CL/F)|Blood samples will be collected by direct venipuncture during regularly scheduled visits according to the collection plan provided in the study protocol.Apparent oral clearance of RAD001 (CL/F) was calculated using AUC in a dosing interval of 24 hours (AUC0-24hours) value on Day 15 as: CL/F = dose/ AUC0-τ|At pre-dose and post-dose: 1 hour, 2 hour, 5 hour, 24 hour of Cycle 1 Day 1, Cycle 1 Day 15 and at pre-dose from Cycle 2 (Day 1) and all subsequent treatment cycles until data cut-off 28Feb2008.|The pharmacokinetics population consists of all patients who have a pharmacokinetic assessment with a sufficient number of evaluable blood samples. The analsyis was limited to RAD001 + BSC arm.||L/hour||Standard Deviation|Mean
732348|NCT00410124|Secondary|Pharmacokinetics of RAD001: Time of the Last Quantifiable Concentration in a Dosing Interval - (Tlast)|Blood samples will be collected by direct venipuncture during regularly scheduled visits according to the collection plan provided in the study protocol.|At pre-dose and post-dose: 1 hour, 2 hour, 5 hour, 24 hour of Cycle 1 Day 1, Cycle 1 Day 15 and at pre-dose from Cycle 2 (Day 1) and all subsequent treatment cycles until data cut-off 28Feb2008.|The pharmacokinetics population consists of all patients who have a pharmacokinetic assessment with a sufficient number of evaluable blood samples. The analsyis was limited to RAD001 + BSC arm.||hour||Full Range|Median
732349|NCT00410124|Secondary|Pharmacokinetics of RAD001: Area Under Curve (AUC) in a Dosing Interval From Time-zero to Time of the Last Quantifiable Concentration. (AUC 0-tlast)|Blood samples will be collected by direct venipuncture during regularly scheduled visits according to the collection plan provided in the study protocol.|At pre-dose and post-dose: 1 hour, 2 hour, 5 hour, 24 hour of Cycle 1 Day 1, Cycle 1 Day 15 and at pre-dose from Cycle 2 (Day 1) and all subsequent treatment cycles until data cut-off 28Feb2008.|The pharmacokinetics population consists of all patients who have a pharmacokinetic assessment with a sufficient number of evaluable blood samples. The analsyis was limited to RAD001 + BSC arm.||ng.h/mL||Standard Deviation|Mean
732351|NCT00410124|Secondary|Pharmacokinetics of RAD001:Peak Concentration in a Dosing Interval (C-max); Pre-dose Concentration at 24-h Time Point in Dosing Interval (C-min) and Average Concentration in a Dosing Interval =(C-avg)|Blood samples will be collected by direct venipuncture during regularly scheduled visits according to the collection plan provided in the study protocol. C-avg= Area under curve (AUC) in a dosing interval from time-zero to time of the last quantifiable concentration (AUC0-tlast)/ time of the last quantifiable concentration in a dosing interval (tlast)|At pre-dose and post-dose: 1 hour, 2 hour, 5 hour, 24 hour of Cycle 1 Day1, Cycle 1 Day 15 and at pre-dose from Cycle 2(day1) and all subsequent treatment cycles up until data cut-off 28 Feb 2008.|The pharmacokinetics population consists of all patients who have a pharmacokinetic assessment with a sufficient number of evaluable blood samples. The analsyis was limited to RAD001 + BSC arm.||ng/mL||Standard Deviation|Mean
732352|NCT00410124|Secondary|Time to Definitive Deterioration of the Physical Functioning Scale (PF)Score of the EORTC QLQ-C30 Questionnaire by at Least 10 Percent Using Kaplan_Meier Method, by Treatment.|The EORTC QLQ-C30 contains 30 items. These include five functional scales (physical, role, emotional, social and cognitive functioning), three symptom scales fatigue, pain, nausea, and vomiting), a global health status/QoL scale, and six single items (dyspnea, diarrhea, constipation, anorexia, insomnia and financial impact). Physical Functioning (PF) sub-scale, consisting of 5 questions each scored from 1 (not at all) to 4 (very much), and with possible values ranging from 5 to 20. Definitive deterioration by at least 10% is defined as a decrease in score by at least 10% compared to baseline, with no later increase above this threshold observed during the course of the study. A single measure reporting a decrease of at least 10% is considered definitive only if it is the last one available for the patient. Time to definitive deterioration is the number of days between the date of randomization and the date of the assessment at which definitive deterioration is seen.|"Baseline and every 28 days under treatment and at discontinuation from RAD001 until 28Feb2008 cutoff date"|Full Analysis Set was performed on the intent-to-treat population which consisted of all randomized patients.||months||95% Confidence Interval|Median
732353|NCT00410124|Secondary|Time to Definitive Deterioration of the FKS-DRS Risk Score by at Least 2 Score Units Using Kaplan-Meier Method, by Treatment.|"The Functional Assessment of Cancer Therapy – Kidney Symptom Index, Disease Related Symptoms (FKSI-DRS) is a set of items to assess symptoms experienced by patients with advanced kidney cancer. These symptoms include fatigue, pain, weight loss, dyspnea, cough, fever and hematuria. There were 4 response categories (1=Not at all, 2= A little, 3=Quite a bit, 4=Very much), sum of item responses can range from 0 to 36. 0= severely symptomatic patient and the highest score is an asymptomatic patient. Definitive deterioration of the FKSI-DRS score was defined as a decrease by at least 2 units compared to baseline, with no later increase above this threshold observed during the study. A single measure reporting a decrease of at least 2 units was considered definitive only if it is the last one available for the patient. Time to definitive deterioration is the number of days between the date of randomization and the date of the assessment at which definitive deterioration is seen."|"Baseline and every 28 days under treatment and at discontinuation from RAD001 until 28Feb2008 cutoff date"|Full Analysis Set was performed on the intent-to-treat population which consisted of all randomized patients.||months||95% Confidence Interval|Median
732354|NCT00410124|Secondary|Analysis of Time to Definitive Deterioration of the Global Health Status/QoL Scale(QL) Scores of the EORTC QLQ-30 Questionnaire by at Least 10 Percent Using Kaplan Meier Method, by Treatment.|The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) contains 30 items. These include a global health status/QoL scale, five functional scales, three symptom scales, and six single items. Global health status / QoL scale (QL), consisting of 2 questions each scored from 1 (very poor) to 7 (excellent), and with possible scores ranging from 2 to 14. Higher score indicates better functioning. Definitive deterioration by at least 10% is defined as a decrease in score by at least 10% compared to baseline, with no increase above this threshold observed during the course of the study. A single measure reporting a decrease of at least 10% is considered definitive only if it is the last one available for the patient. Time to definitive deterioration is the number of days between the date of randomization and date of assessment at which definitive deterioration is seen.|"Baseline and every 28 days under treatment and at discontinuation from RAD001 until 28Feb2008 cutoff date"|Full Analysis Set was performed on the intent-to-treat population which consisted of all randomized patients.||months||95% Confidence Interval|Median
732355|NCT00410124|Secondary|Duration of Response in Patients Who Receive RAD001 Plus BSC Versus Placebo Plus BSC|Duration of overall response (CR or PR) applies only to patients whose Best Overall Response (BOR) was Complete Response (CR) or Partial Response (PR). The start date is the date of first documented response (CR or PR) and the end date is the date of event defined as the first documented progression or death. Radiological assessments: every 8 weeks (+/-1 week) during the first year and every 12 weeks (+/- 1 week) during the second year and thereafter and at the end of the study.|Time from randomization to dates of disease progression, death from any cause or last tumor assessment reported, between date of first patient randomized until 28Feb2008 cutoff date|Full Analysis Set was performed on the intent-to-treat population which consisted of all randomized patients.||months||95% Confidence Interval|Median
732356|NCT00410124|Secondary|Best Overall Response Rate in Patients Who Receive RAD001 Plus BSC Versus Matching Placebo Plus BSC|The Best Overall Response rate (BOR) is defined as the percentage of patients having achieved confirmed Complete Response + Partial Response. Complete Response (CR) = at least two determinations of CR at least 4 weeks apart before progression. • Partial response (PR) = at least two determinations of PR or better at least 4 weeks apart before progression. Radiological assessments: every 8 weeks (+/-1 week) during the first year and every 12 weeks (+/- 1 week) during the second year and thereafter and at the end of the study.|Time from randomization to dates of disease progression, death from any cause or last tumor assessment reported, between date of first patient randomized until 28Feb2008 cutoff date|Full analysis set was performed on the intent-to-treat population which consisted of all randomized patients.||Percentage of Participants||95% Confidence Interval|Number
732357|NCT00410124|Secondary|Overall Survival (OS) Assessed by the Monthly Overall Survival Assessments|Overall survival (OS) was defined as the time from date of randomization to date of death due to any cause. Kaplan-Meier methodology was used to estimate the median overall survival for each treatment group|Assessed every month up to 2 years after the last patient was randomized into the study from the date of randomization to the time of death. (Data cutoff was 15Nov2009)|Full analysis set was performed on the intent-to-treat population which consisted of all randomized patients.||Months||95% Confidence Interval|Median
732358|NCT00410124|Primary|Progressive Free Survival (PFS) in Patients Who Receive RAD001 Plus Best Supportive Care(BSC) Versus Patients Who Receive Matching Placebo Plus BSC|Progression Free survival is defined as the time from randomization to the date of first documented disease progression or death from any cause. The primary statistical analysis of PFS was based on central radiological assessments using a one-sided stratified log-rank test. Radiological assessments: every 8 weeks (+/-1 week) during the first year and every 12 weeks (+/- 1 week) during the second year and thereafter and at the end of the study. Kaplan-Meier methodology was used to estimate the median PFS for each treatment group.|Time from randomization to dates of disease progression, death from any cause or last tumor assessment reported between date of first patient randomized until 28Feb2008 cut of date.|Full Analysis Set was performed on the intent-to-treat population which consisted of all randomized patients.||Months||95% Confidence Interval|Median
732359|NCT00410150|Primary|Length of Stay|Time to discharge eligibility (hours)|Hospital discharge|||hours||Standard Error|Mean
732360|NCT00410163|Secondary|Number of Participants With Progression or Death|Disease progression is characterized by at least one of the following, per the Guidelines for the Diagnosis and Treatment of Chronic Lymphocytic Leukemia: a >=50% increase in the sum of the products of at least two lymph nodes on two consecutive determinations 2 weeks apart (at least one node must be >=2 centimeters); or the appearance of new palpable lymph nodes; or a >=50% increase in liver and/or spleen size (measurement below the costal margin); or the appearance of palpable hepatomegaly or splenomegaly not previously present; or a >=50% increase in the numbers of circulating lymphocytes to at least 5.0 * 10^9/Liter; or transformation to a more aggressive histology (e.g., Richter’s syndrome or prolymphocytic leukemia with >55% prolymphocytes). For participants who were lost to follow-up, PFS was censored at the date of the last attended visit at which the endpoint was assessed. The Kaplan-Meier method was used to estimate PFS.|From time of randomization to first documented evidence of disease progression or death due to any cause, whichever came first, assessed over 2 years|FAS||Participants|||Number
732361|NCT00410163|Secondary|Vss After the First Infusion (Visit 2, Week 0) and Sixth Infusion (Visit 29, Week 20)|Vss is defined as the volume of distribution at steady state of ofatumumab.|Visit 2 (Week 0; up to 4 weeks after dose) and Visit 29 (Week 20; up to 9 months after dose)|FAS. Data were provided for the number of participants attending each visit for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed.||liters||Geometric Coefficient of Variation|Geometric Mean
732362|NCT00410163|Secondary|CL After the First Infusion (Visit 2, Week 0) and Sixth Infusion (Visit 29, Week 20)|CL is the clearance of drug from plasma, which is defined as the volume of plasma from which the drug is cleared per unit time.|Visit 2 (Week 0; up to 4 weeks after dose) and Visit 29 (Week 20; up to 9 months after dose)|FAS. Data were provided for the number of participants attending each visit for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed.||Milliliters per hour (mL/h)||Geometric Coefficient of Variation|Geometric Mean
732363|NCT00410163|Secondary|t1/2 After the First Infusion (Visit 2, Week 0) and Sixth Infusion (Visit 29, Week 20)|t1/2 is defined as terminal half-life and is the time required for the amount of drug in the body to decrease by half.|Visit 2 (Week 0; up to 4 weeks after dose) and Visit 29 (Week 20; up to 9 months after dose)|FAS. Data were provided for the number of participants attending each visit for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed.||hours||Geometric Coefficient of Variation|Geometric Mean
732364|NCT00410163|Secondary|AUC(0-inf) and AUC(0-672) After the First Infusion (Visit 2, Week 0) and Sixth Infusion (Visit 29, Week 20)|AUC is defined as the area under the ofatumumab concentration-time curve as a measure of drug exposure. AUC(0-672) is AUC from start of infusion to 672 hours after start of infusion; AUC(0-inf) is AUC from start of infusion extrapolated to infinity.|Visit 2 (Week 0; up to 4 weeks after dose) and Visit 29 (Week 20; up to 9 months after dose)|FAS. Data were provided for the number of participants attending each visit for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed.||Milligrams * hour per liter (mg.h/L)||Geometric Coefficient of Variation|Geometric Mean
732365|NCT00410163|Secondary|Ctrough and Cmax at the First Infusion (Visit 2, Week 0) and Sixth Infusion (Visit 29, Week 20)|Cmax is defined as the maximum concentration of drug in plasma samples. Ctrough is defined as the trough plasma concentration (measured concentration at the end of a dosing interval [taken directly before next administration]). No drug is present before the first infusion; therefore, there are no Ctrough results for the first infusion.|Visit 2 (Week 0; up to 4 weeks after dose) and Visit 29 (Week 20; up to 9 months after dose)|FAS. Data were provided for the number of participants attending each visit. Participants withdrawn during the study were not analyzed.||Milligrams per liter (mg/L)||Geometric Coefficient of Variation|Geometric Mean
732366|NCT00410163|Secondary|Number of Participants Classified as Responders Having CR Who Tested Negative for Minimal Residual Disease (MRD)|MRD refers to small number of leukemic cells that remain in the participant during treatment or after treatment when the participant has achieved CR. For all participants who achieved CR, the follow-up bone marrow sample was tested for malignant B cells (CD5+CD19+) to determine if there was any MRD.|From start of treatment (Day 1 of Week 0) until 3 months after start of last infusion (up to course 6 or Week 32)|FAS. Only participants with CR at Visit 34 were analyzed.||participants|||Number
732367|NCT00410163|Primary|Number of Participants (Par.) Who Were Classified as Responders and Non-responders|Par. were evaluated by an IRC in accordance with NCI-WG 1996 guideline. Responders: CR, Nodular Partial Remission (nPR, same as CR, but persistent bone marrow nodules), and Partial Remission (PR, >=50% decrease in lymphocytes from pretreatment baseline (BL) value, >=50% reduction in lymphadenopathy, >=50% reduction of liver/spleen and neutrophils >= 1.5*10^9/L or platelets >100*10^9/L or hemoglobin >11 g/dL (or 50% improvement over BL for neutrophils, platelets, hemoglobin); non-responders: Stable Disease (SD, did not achieve CR/PR, and no PD), Progressive Disease (PD), or Not Evaluable (NE).|From start of treatment (Day 1 of Week 0) until 3 months after start of last infusion (up to Week 32)|FAS||participants|||Number
732368|NCT00410163|Secondary|Percent Change From Screening (Visit 1) in Complement (CH50) Levels at Visit 9 (Week 4)|Blood samples were drawn from participants at Visits 1 and 9 for analysis of complement (CH50) levels. Analysis of CH50 was done in batches, and CH50 levels were measured two hours after the end of study medication infusion. Percent change from Screening (Visit 1, Week -2) = (value at Visit 9 minus value at Visit 1 divided by value at Visit 1) * 100.|Visit 1 (Week -2) and Visit 9 (Week 4)|FAS. Data were provided for the number of participants attending Visit 9. Participants withdrawn during the study were not analyzed.||Percent change in complement levels||Full Range|Median
732369|NCT00410163|Secondary|Number of Participants Who Reported Myelosuppression (Anemia, Leukopenia, Neutropenia, and Thrombocytopenia)|Myelosuppression is one of the expected AEs for FC treatment and is defined as the decrease in the ability of the bone marrow to produce blood cells. The number of participants with myelosuppression was assessed from laboratory measurements with Grades 3(severe)-4 (life-threatening/disabling) (1, mild; 2, moderate; 5, death) according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The CTCAE is issued by the National Cancer Institute (NCI) and is the standard classification used for the severity grading scale for AEs in cancer therapy clinical studies.|From first treatment (Visit 2) up to Visit 43 (Month 60)|FAS||participants|||Number
732370|NCT00410163|Secondary|Number of Participants With Positive Human Anti-human Anti Bodies (HAHA) at Visits 1, 21, 35, and 39|HAHA are indicators of immunogenicity to ofatumumab. Blood samples were drawn from participants at Visits 1, 21, 35, and 39 for analysis of HAHA. Analysis of HAHA was done in batches.|Visits 1 (Screening, Visit -2), 21 (Week 12), 35 (Month 6), and 39 (Month 18)|FAS. Data were provided for the number of participants attending each visit. Participants withdrawn during the study were not analyzed.||participants|||Number
732371|NCT00410163|Secondary|Number of Participants Who Experienced Any Adverse Event From First Treatment (Visit 2) to Visit 43 (Month 60)|An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. A list of AEs experienced in the study at a frequency threshold of 5% can be found in the AE section.|From first treatment (Visit 2) up to Visit 43 (Month 60)|FAS||participants|||Number
732372|NCT00410163|Secondary|Median Percent Change in CD5+CD19+ and CD5+CD20+ Cells in Peripheral Blood From Onset of Course 3 Throughout Follow-up (FU) Compared to Screening|Malignant B cells (CD5+CD19+ and CD5+CD20+) were measured in peripheral blood samples by flow cytometry. Percent change from Screening (Visit 1, Week -2) = (value at indicated visits minus value at Visit 1 divided by value at Visit 1) * 100. Visits 33 and 34 are measured in the number of months from the start of the last infusion. The start of the last infusion could have occurred up to Week 20.|Baseline Visit 2 (Week [Wk] 0); Visits 15 (Wk 8), 21 (Wk 12), 25 (Wk 16), 29 (Wk 20), 33 (Month [M] 1 after start of last infusion [LI]), 34 (M 3 after start of LI)|FAS. Data were provided for the number of participants attending each visit. Participants withdrawn during the study were not analyzed.||percent change in cells||Full Range|Median
732373|NCT00410163|Secondary|Median Percent Change in Tumor Size From Baseline (Visit 2, Wk 0) at Visits 9, 21, 25, 29, 33, 34, 35, and 37|Tumor size was measured by physical examination of palpable abnormal lymph nodes. Percent change from Baseline (Visit 2, Week 0) = (value at indicated visits minus value at Visit 2 divided by value at Visit 2) * 100. Visits 33, 34, 35, 36, and 37 are measured in the number of months from the start of the last infusion. The start of the last infusion could have occurred up to Week 20.|Baseline Visit 2 (Week [Wk] 0); Visits 9 (Wk 4), 21 (Wk 12), 25 (Wk 16), 29 (Wk 20), 33 (Month [M] 1 after start of last infusion [LI]), 34 (M 3 after start of LI), 35 (M 6 after start of LI), 36 (M 9 after start of LI), and 37 (M 12 after start of L|FAS. Data were provided for the number of participants attending each visit. Participants withdrawn during the study were not analyzed.||percent change in tumor size||Full Range|Median
732374|NCT00410163|Secondary|Time to Next Anti-chronic Lymphocytic Leukemia (CLL) Therapy or Death|Time to next anti-CLL (anti-lymphoma) therapy was defined as the time from randomization until the time of first administration of the next anti-lymphoma therapy other than ofatumumab or death. For participants who were lost to follow-up, the time was censored at the date of the last attended visit at which the endpoint was assessed.|From time of randomization to first administration of next anti-CLL therapy other than ofatumumab or death, assessed over 5 years|FAS||months||95% Confidence Interval|Median
732375|NCT00410163|Secondary|Progression-Free Survival|Progression-free survival (PFS) was defined as the time from randomization until the first radiologically or clinically documented evidence of progression or death due to any cause, if sooner. For participants who were lost to follow-up, PFS was censored at the date of the last attended visit at which the endpoint was assessed. The Kaplan-Meier method was used to estimate PFS.|From time of randomization to first documented evidence of disease progression or death due to any cause, whichever came first, assessed over 2 years|FAS||months||95% Confidence Interval|Median
732376|NCT00410163|Secondary|Duration of Response|The duration of response was defined as the time from the initial response (the first visit at which response was observed) to progression or death. For participants who were lost to follow-up, duration of response was censored at the date of the last attended visit at which the endpoint was assessed.|From time of initial response to disease progression or death, whichever came first, assessed over 2 years|FAS. Only those participants classified as responders were analyzed.||months||95% Confidence Interval|Median
732377|NCT00410163|Primary|Number of Participants (Par.) With Complete Remission (CR), Measured From Start of Treatment Until 3 Months After Last Infusion|"Par. were evaluated for response by an Independent Endpoint Review Committee (IRC) in accordance with the National Cancer Institute-sponsored Working Group (NCI-WG) 1996 guideline. Par. with Complete Remission (CR) were classified as complete responders. As per NCI-WG, CR requires all of the following criteria for a period of >=2 months: absence of lymphadenopathy (all lymph nodes <1.0 centimeters), no hepatomegaly/splenomegaly, absence of constitutional symptoms, lymphocytes <=4.0*10^9/liter (L), neutrophil leukocytes >=1.5*10^9/L, platelets >100*10^9/L, and hemoglobin >11 grams/deciliter."|Start of treatment (Day 1 of Week 0) until 3 months after start of last infusion (up to Week 32)|Full Analysis Set (FAS): all participants who had been exposed to study drug irrespective of their compliance to the planned course of treatment||participants|||Number
732378|NCT00410189|Primary|8-Week Disease Control Rate (Complete Response, Partial Response and Stable Disease)|The disease control rate (DCR) is the percentage of patients without progression at 8 weeks. Disease control rate defined as: Complete Response (CR): Disappearance of all non-target/target lesions and normalization of tumor marker level. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD since the treatment started.|Baseline to 8 Weeks|||percentage of participants|||Number
732379|NCT00410189|Secondary|8 Week Progression-Free Survival|Progression-free survival (PFS) was estimated using Kaplan-Meier method. PFS was defined as time from start of treatment to disease progression.|Every 8 weeks till disease progression.|||months||Full Range|Median
734274|NCT00425269|Secondary|High-Density Lipoprotein Cholesterol, Baseline||baseline|||mmol/L||95% Confidence Interval|Mean
732380|NCT00410202|Secondary|Number of Participants With Laboratory Abnormalities: Serum Chemistry|ULN=upper limit of normal (Normal ranges are Central lab data and vary according to the site). ALT:>1.25*ULN, AST:>1.25*ULN, ALP:>1.25*ULN, Total Bilirubin:>1.1*ULN, Serum Lipase:>1.10*ULN, Creatinine:>1.1*ULN, Blood Urea Nitrogen:1.25*ULN, Hyperglycemia:>116 mg/dL, Hypoglycemia:<64 mg/dL, Hyponatremia:<132meq/L, Hypokalemia:<3.4 meq/L, Albumin:≥1g/dL decrease from baseline, <3 g/dL; Hypernatremia:>148 meq/L, Hyperkalemia:>5.6 meq/L, Hypokalemia:<3.4 meq/L, Hyperchloremia:>113 meq/L, Hypochloremia:<93 meq/L; ALT flare: on treatment (OT), >2*Baseline and >10*ULN; off treatment (OF), 2*end of dosing value and >10*ULN|On treatment : Day 1 through Week 100 + 5 days; Offtreatment = End of OT period through 24 weeks|All treated participants. n = number of participants in the OF period.||participants|||Number
732381|NCT00410202|Secondary|Number of Participants With Laboratory Abnormalities: Hematology|Criteria for hematology abnormalities were: Hemoglobin: <=11.0 g/dL; White Blood Cells: <4000/mm^3; Absolute Neutrophils (includes absolute bands): <1500/mm^3; Platelets: <=99,000/mm^3; International Normalized Ratio: ≥ 1.5 and ≥ 0.5 from baseline.|From start of study through Week 100 + 5 days|All treated participants.||participants|||Number
732382|NCT00410202|Secondary|Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations Due to Adverse Events or Laboratory Abnormalities During Treatment|AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to any AEs were recorded. Grade 1 = mild, Grade 2= moderate, Grade 3 = severe, Grade 4 = life threatening/disabling, Grade 5 = death.|From start of study therapy through Week 100 + 5 days|All treated participants.||participants|||Number
732383|NCT00410202|Secondary|Cumulative Probability of Emergent Genotypic Resistance at Year 2|"Cumulative probability (CP): Ptotal=1-(1-Pyr1)*(1-Pyr2) where Pyear(i)= number of participants with events at Year i divided by number of participants at risk at Year i for i = 1,2. An event is defined as resistance or resistance with virologic breakthrough in a yearly interval. Participants 'at risk' are those who were treated during Year i and did not develop that resistance or resistance with virologic breakthrough prior to Year i. CP were calculated separately for ETV, ADV and TDF resistance. Participants who discontinue from study drug in Year i were assumed to be in follow up for the entire year. (VBT; a ≥ 1 log10 increase in HBV DNA from the on-treatment nadir, confirmed by 2 sequential HBV DNA results or observed at the last on-treatment HBV DNA). ETVr = ETV resistance (rtM204V/I/S plus any substitution at rtT184, rtS202, or rtM250); ADVr/TDFr = ADV/TDF resistance (rtA181T/V or rtN236T = ADVr and TDFr, rtA194T = TDFr only)."|Year 2|Treated participants who were tested for resistance were analyzed, ie. They met the following selection criteria: 1) participants with HBV DNA ≥ 50 IU/mL at Week 96 or at the last on-treatment visit and 2) who developed VBT. n=participants||percentage of participants|||Number
732384|NCT00410202|Secondary|Cumulative Probability of Emergent Genotypic Resistance at Year 1|"yr=year. Cumulative probability (CP): Ptotal=1-(1-Pyr1)*(1-Pyr2) where Pyear(i)= number of participants with events at Year i divided by number of participants at risk at Year i for i = 1,2. An event is defined as resistance or resistance with virologic breakthrough in a yearly interval. Participants 'at risk' are those who were treated during Year i and did not develop that resistance or resistance with virologic breakthrough prior to Year i. CP were calculated separately for ETV, ADV and TDF resistance. Participants who discontinue from study drug in Year i were assumed to be in follow up for the entire year. (VBT; a ≥ 1 log10 increase in HBV DNA from the on-treatment nadir, confirmed by 2 sequential HBV DNA results or observed at the last on-treatment HBV DNA). ETVr = ETV resistance (rtM204V/I/S plus any substitution at rtT184, rtS202, or rtM250); ADVr/TDFr = ADV/TDF resistance (rtA181T/V or rtN236T = ADVr and TDFr, rtA194T = TDFr only)."|Year 1|Treated participants who were tested for resistance, ie. met the following selection criteria. 1) participants with HBV DNA ≥ 50 IU/mL at Week 48 or at the last on-treatment visit and 2) who developed VBT . n=participants||percentage of participants|||Number
732385|NCT00410202|Secondary|Percentage of Participants With HBsAg Seroconversion at Week 96|HBsAg = a part of the hepatitis B virus that, when in the blood, is an early marker of infection. HBs seroconversion is defined as HBsAg loss with positive HBsAb.|Week 96|Participants who received at least 1 dose of study therapy were analyzed. Participants with missing efficacy assessments were considered as a failure.||percentage of participants|||Number
732386|NCT00410202|Secondary|Percentage of Participants With HBsAg Seroconversion at Week 48|HBsAg = a part of the hepatitis B virus that, when in the blood, is an early marker of infection. HBs seroconversion is defined as HBsAg loss with positive HBsAb.|Week 48|Participants who received at least 1 dose of study therapy. Participants with missing efficacy assessments were considered as a failure.||percentage of participants|||Number
732387|NCT00410202|Secondary|Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 96|HBsAg = a part of the hepatitis B virus that, when in the blood, is an early marker of infection. HBsAg loss = HBsAg-negative at the specified analysis week.|Week 96|Participants who received at least 1 dose of study therapy were analyzed. Participants with missing efficacy assessments were considered as a failure.||percentage of participants|||Number
732388|NCT00410202|Secondary|Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 48|HBsAg = a part of the hepatitis B virus that, when in the blood, is an early marker of infection. HBsAg loss = HBsAg-negative at the specified analysis week.|Week 48|Participants who received at least 1 dose of study therapy. Participants with missing efficacy assessments were considered as a failure.||percentage of participants|||Number
732389|NCT00410202|Secondary|Percentage of Participants With HBeAg Seroconversion at Week 96 (Treated HBeAg-positive Participants Only)|HBeAg is a hepatitis B viral protein. It is an indicator of active viral replication. HBeAg Seroconversion = HBeAg Loss and Presence of Hepatitis B e Antibody (HBeAb).|Week 96|Participants who received at least 1 dose of study therapy and were HBeAG positive. Participants with missing efficacy assessments were considered as a failure.||percentage of participants|||Number
732390|NCT00410202|Secondary|Percentage of Participants With HBeAg Seroconversion at Week 48 (Treated HBeAg-positive Participants Only)|HBeAg is a hepatitis B viral protein. It is an indicator of active viral replication. HBeAg Seroconversion = HBeAg Loss and Presence of Hepatitis B e Antibody (HBeAb).|Week 48|Participants who received at least 1 dose of study therapy and were HBeAG positive. Participants with missing efficacy assessments were considered as a failure.||percentage of participants|||Number
732394|NCT00410202|Secondary|Percentage of Participants With Alanine Aminotransferase (ALT) > 1 x Upper Limit of Normal (ULN) at Baseline Who Achieve ALT Normalization at Week 48|ALT normalization=ALT level being less than or equal to 1 times the upper limit of normal (ULN). ULN for ALT is 37 or 48 U/L.|Week 48|Participants who received at least 1 dose of study therapy and had ALT > 1 x ULN at baseline (day 1). Participants with missing efficacy assessments were considered as a failure.||percentage of participants|||Number
732395|NCT00410202|Secondary|Change in Mean log10 From Baseline in HBV DNA at Week 96|HBV DNA was analyzed by PCR, using the Roche COBAS® TaqMan HPS assay. Reduction in log10 HBV count=reduced viral load.|Baseline, Week 96|Participants who received at least 1 dose of study therapy and had both baseline and post-baseline values were analyzed. n= participants with baseline and Week 96 values.||participants||Standard Error|Mean
732396|NCT00410202|Secondary|Change in Mean log10 From Baseline in HBV DNA at Week 48|HBV DNA was analyzed by PCR, using the Roche COBAS®TaqMan TaqMan HPS assay. Reduction in log10 HBV count=reduced viral load, negative values means reduction.|Baseline, Week 48|Participants who received at least 1 dose of study therapy and had both baseline and post-baseline values. n=participants with baseline and Week 48 values.||log10 (IU/mL||Standard Error|Mean
732397|NCT00410202|Secondary|Percentage of Participants With HBV DNA by PCR Category at Week 96|HBV DNA assessments were performed using the Roche COBAS® TaqMan HPS assay.|Week 96|Participants who received at least 1 dose of study therapy were analyzed.||percentage of participants|||Number
732398|NCT00410202|Secondary|Percentage of Participants With HBV DNA by PCR Category at Week 48|HBV DNA assessments were performed using the Roche COBAS® TaqMan High Pure System (HPS) assay.|Week 48|Participants who received at least 1 dose of study therapy.||percentage of participants|||Number
732399|NCT00410202|Secondary|Percentage of Participants Who Achieve HBV DNA < Lower Limit of Detection (LOD = 10 IU/mL [Approximately 58 Copies/mL]) at Week 96|HBV DNA assessments were performed using the Roche COBAS® TaqMan HPS assay. LOD is the lowest amount or concentration of analyte in a sample, which can be reliably detected, but not necessarily quantified.|Week 96|Participants who received at least 1 dose of study therapy. Participants with missing efficacy assessments were considered as a failure.||percentage of participants|||Number
732400|NCT00410202|Secondary|Percentage of Participants Who Achieve HBV DNA < Lower Limit of Detection (LOD = 10 IU/mL [Approximately 58 Copies/mL]) at Week 48|HBV DNA assessments were performed using the Roche COBAS® TaqMan HPS assay. LOD is the lowest concentration level that can be determined to be statistically different from a blank (99% confidence). The LOD is typically determined to be in the region where the signal to noise ratio is greater than 5. Limits of detection are matrix-, method-, and analyte-specific.|Week 48|Participants who received at least 1 dose of study therapy. Participants with missing efficacy assessments were considered as a failure.||percentage of participants|||Number
732401|NCT00410202|Secondary|Percentage of Participants Who Achieve HBV DNA < Lower Limit of Quantitation (LOQ = 29 IU/mL [Approximately 169 Copies/mL]) at Week 96|HBV DNA assessments were performed using the Roche COBAS® TaqMan HPS assay. LOQ is the level above which quantitative results may be obtained with a specified degree of confidence. The LOQ is mathematically defined as equal to 10 times the standard deviation of the results for a series of replicates used to determine a justifiable limit of detection. Percentage n/N: n= number of participants with outcome result; N = number of participants analyzed.|Week 96|Participants who received at least 1 dose of study therapy. Participants with missing efficacy assessments were considered as a failure.||Percentage of participants|||Number
732402|NCT00410202|Secondary|Percentage of Participants Who Achieve HBV DNA < Lower Limit of Quantitation (LOQ = 29 IU/mL [Approximately 169 Copies/mL]) at Week 48|HBV DNA assessments were performed using the Roche COBAS® TaqMan HPS assay. LOQ is the level above which quantitative results may be obtained with a specified degree of confidence. The LOQ is mathematically defined as equal to 10 times the standard deviation of the results for a series of replicates used to determine a justifiable limit of detection. Percentage n/N: n= number of participants with outcome result; N = number of participants analyzed.|Week 48|Participants who received at least 1 dose of study therapy. Participants with missing efficacy assessments were considered as a failure.||percentage of participants|||Number
732403|NCT00410202|Secondary|Percentage of Participants With HBV DNA < 50 IU/mL (Approximately 300 Copies/mL) by PCR at Week 96|HBV DNA assessments were performed using the Roche COBAS® TaqMan HPS assay. HBV DNA < 50 IU/mL = approximately 300 copies/mL. Percentage n/N: n= number of participants with HBV DNA <50 IU/mL; N = number of participants analyzed.|Week 96|Participants who received at least 1 dose of study therapy. Participants with missing efficacy assessments were considered as a failure.||Percentage of participants|||Number
732404|NCT00410202|Primary|Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) < 50 IU/mL (Approximately 300 Copies/mL) by Polymerase Chain Reaction (PCR) at Week 48|HBV DNA assessments were performed using the Roche COBAS® TaqMan High Pure System (HPS) assay. HBV DNA less than (<)50 International units per milliliter (IU/mL) = approximately 300 copies/mL. Percentage of participants calculated n/N; n= number of participants with HBV DNA <50 IU/mL; N = number of participants analyzed.|Week 48|Participants who received at least 1 dose of study therapy. Participants with missing efficacy assessments were considered as a failure.||percentage of participants|||Number
732405|NCT00410280|Secondary|Number of Participants With Antibodies to IMA-638||Baseline up to Day 168|ITT population included all randomized participants who received at least 1 dose administration of the test article.||participants|||Number
732406|NCT00410280|Secondary|Serum Decay Half-Life (t1/2) for IMA-638|Serum decay half-life is the time measured for the serum concentration to decrease by one half.|Day 1, 8, 14, 21, 35, 56, 84, 112, 140, 168|Evaluable population included all randomized participants who received at least 1 dose administration of the test article and had evaluable pharmacokinetic data.||days||Standard Deviation|Mean
732407|NCT00410280|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] for IMA-638|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Day 1, 8, 14, 21, 35, 56, 84, 112, 140, 168|Evaluable population included all randomized participants who received at least 1 dose administration of the test article and had evaluable pharmacokinetic data.||mcg*hr/mL||Standard Deviation|Mean
734275|NCT00425269|Secondary|Insulin, 2-h, Baseline||baseline|||pmol/L||95% Confidence Interval|Mean
734276|NCT00425269|Secondary|Insulin, 0-h, Baseline||baseline|||pmol/L||95% Confidence Interval|Mean
732408|NCT00410280|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] for IMA-638|Area under the plasma concentration time-curve from zero to the last measured concentration (AUC0-t).|Day 1, 8, 14, 21, 35, 56, 84, 112, 140, 168|Evaluable population included all randomized participants who received at least 1 dose administration of the test article and had evaluable pharmacokinetic data.||microgram*hour/milliliter (mcg*hr/mL)||Standard Deviation|Mean
732409|NCT00410280|Secondary|Time to Reach Maximum Observed Serum Concentration (Tmax) for IMA-638||Day 1, 8, 14, 21, 35, 56, 84, 112, 140, 168|Evaluable population included all randomized participants who received at least 1 dose administration of the test article and had evaluable pharmacokinetic data.||days||Standard Deviation|Mean
732410|NCT00410280|Secondary|Maximum Observed Serum Concentration (Cmax) for IMA-638||Day 1, 8, 14, 21, 35, 56, 84, 112, 140, 168|Evaluable population included all randomized participants who received at least 1 dose administration of the test article and had evaluable pharmacokinetic data.||microgram/milliliter(mcg/mL)||Standard Deviation|Mean
732411|NCT00410280|Secondary|Protein Expression in Sputum and Blood|Sputum induction was performed after each methacholine challenge and at hour 7 after each allergen inhalation challenge. The baseline for this outcome measure was defined as the last value prior to dosing.|Screening (Day-13, -14, -15), Day 1, 13, 14, 15, 34, 35, 36, 112|Data for this outcome measure w as not analyzed because the study w as stopped early after interim analysis and only safety and key efficacy analyses w ere performed.|||||
732412|NCT00410280|Secondary|Messenger Ribonucleic Acid (mRNA) Gene Expression in Sputum and Blood|Sputum induction was performed after each methacholine challenge and at hour 7 after each allergen inhalation challenge. The baseline for this outcome measure was defined as the last value prior to dosing.|Screening (Day-13, -14, -15), Day 1, 13, 14, 15, 34, 35, 36, 112|Data for this outcome measure was not analyzed because the study was stopped early after interim analysis and only safety and key efficacy analyses were performed.|||||
732413|NCT00410280|Secondary|Blood Levels of Interleukin-13 (IL-13)||Screening, baseline, Day 1, 8, 14, 21, 35, 56, 84, 112, 140, 168|Data for this outcome measure was not analyzed because the study was stopped early after interim analysis and only safety and key efficacy analyses were performed.|||||
732414|NCT00410280|Secondary|Change From Baseline in Total Blood Eosinophil Counts at Day 8, 13, 21, 34, 56, 84 and 168|The baseline for the outcome measure was defined as the last post-dose measurement obtained prior to the allergen challenge (planned on Day 13 and 34).|Baseline, Day 8, 13, 21, 34, 56, 84, 168|"ITT population included all randomized participants who received at least 1 dose administration of the test article. Here, n signifies participants evaluated for this measure at the specified time point for each arm."||10^9 cells/Liter||Standard Error|Mean
732415|NCT00410280|Secondary|Total Blood Eosinophil Counts at Baseline|The baseline for the outcome measure was defined as the last post-dose measurement obtained prior to the allergen challenge (planned on day 13 and 34).|Baseline|ITT population included all randomized participants who received at least 1 dose administration of the test article.||10^9 cells/Liter||Standard Deviation|Mean
732416|NCT00410280|Secondary|Change From Baseline in Allergen Specific and Total Immunoglobulin E (IgE) Count at Day 13, 34, 56, 112 and 168|The baseline for the outcome measure was defined as the last post-dose measurement obtained prior to the allergen challenge (planned on Day 13 and 34). Results are reported for total IgE count.|Baseline, Day 13, 34, 56, 112, 168|"ITT population. Here, n signifies participants evaluated for this measure at the specified time point for each arm. Allergen-specific IgE was not analyzed because the study was stopped early after interim analysis and only safety and key efficacy analyses were performed."||kU/L||Standard Error|Mean
732417|NCT00410280|Secondary|Allergen Specific and Total Immunoglobulin E (IgE) Count at Baseline|The baseline for the outcome measure was defined as the last post-dose measurement obtained prior to the allergen challenge within a given challenge triad (planned on day 13 and 34). The challenge triad included pre-allergen methacholine inhalation challenge, allergen inhalation challenge, and post-allergen methacholine inhalation challenge. Results are reported for total IgE count.|Baseline|ITT population included all randomized participants who received at least 1 dose administration of the test article. Allergen-specific IgE was not analyzed because the study was stopped early after interim analysis and only safety and key efficacy analyses were performed.||kilo unit/liter (kU/L)||Standard Deviation|Mean
732418|NCT00410280|Secondary|Change From Baseline in Total and Differential Sputum Cell Counts at Day 14 and 35|The collected sputum was planned to be analyzed for epithelial cells, eosinophils, lymphocytes, neutrophils, metachromatic cells, or macrophages counts. Sputum induction was to be performed after each methacholine challenge and at 7 hours after each allergen inhalation challenge.|Baseline, Day 14, 35|Data was not analyzed because the study was stopped early after interim analysis and only safety and key efficacy analyses were performed.|||||
732419|NCT00410280|Secondary|Change From Pre-allergen Challenge in Provocative Concentration of Methacholine Causing a 20% Fall in FEV1 (PC20) to Post-allergen Challenge For Screening, Day 14 and 35 Challenge|Methacholine inhalation test was performed to determine airway hyper-reactivity using provocative concentration 20 (PC20). PC20 was the lowest concentration of methacholine at which participant had 20% decrease from baseline in FEV1. Pre-allergen challenge methacholine inhalation test was performed 1 day prior to the allergen challenge and post-allergen challenge methacholine inhalation test was performed 1 day after to the allergen challenge (that is, pre- and post-allergen methacholine inhalation test was conducted on Day -15 and -13 for Screening allergen challenge, Day 13 and 15 for Day 14 allergen challenge and Day 34 and 36 for Day 35 allergen challenge, respectively). For each methacholine inhalation test, baseline FEV1 was defined as the lowest value among the triplicate readings taken after administration of the diluent (saline administration). Difference between post-allergen challenge and pre-allergen challenge was expressed as log2 (post-allergen PC20 – pre-allergen PC20).|Day -15, -13 for Screening (Day -14) challenge; Day 13, 15 for Day 14 challenge; Day 34, 36 for Day 35 challenge|ITT population included all randomized participants who received at least 1 dose administration of the test article.||Log2 milligram/milliliter (log2 mg/mL)||Standard Deviation|Mean
732428|NCT00403403|Secondary|Percentage of Participants With an Objective Response|"Objective response was defined as a complete or partial response (per RECIST) determined by two investigator assessments conducted at least 4 weeks apart.
Complete Response (CR), Partial Response (PR), Incomplete Response (IR), Stable Disease (SD) (per RECIST):
Target Lesions Non-Target Lesions New Lesions Overall Response CR CR No CR CR IR/SD No PR PR Non-PD No PR"|Randomization until progression or lost to follow-up (up to 2 years)|Intent-to-treat population||Percentage of participants|||Number
732420|NCT00410280|Secondary|Area Under the Percent Drop in Forced Expiratory Volume in 1 Second Curve (AUC FEV1) From Time 0 to 3 Hours for Early-Phase Asthma Response (EAR)|Allergen inhalation test was performed at Screening, Day 14 and 35 to elicit airway responses similar to those that follow natural allergen exposure. FEV1 was the maximal volume of air exhaled in 1 second of a forced expiration from a position of full inspiration. EAR was characterized by a fall in FEV1 >=20% at 0 to 3 hours post-allergen inhalation. Area under the percent drop in FEV1 relative to the pre-allergen baseline FEV1 from 0 to 3 hours at each visit was computed using the linear trapezoidal rule. Pre-allergen baseline FEV1 was performed in triplicate using spirometry and the best of the 3 values was selected.|Pre-allergen baseline, 10, 20, 30, 45, 60, 90, 120, 180 minutes post-allergen inhalation Screening, Day 14, 35|ITT population included all randomized participants who received at least 1 dose administration of the test article.||percent drop*hour||Standard Deviation|Mean
732421|NCT00410280|Secondary|Maximum Percent Drop From Pre-allergen Baseline in Forced Expiratory Volume in 1 Second (FEV1) for Early-Phase Asthma Response (EAR) at Screening, Day 14 and 35|Allergen inhalation test was performed at Screening, Day 14 and 35 to elicit airway responses similar to those that follow natural allergen exposure. FEV1 was the maximal volume of air exhaled in 1 second of a forced expiration from a position of full inspiration. EAR was characterized by a fall in FEV1 >=20% at 0 to 3 hours post-allergen inhalation. Maximum drop in FEV1 relative to the pre-allergen baseline FEV1 between 0 to 3 hours was reported. Pre-allergen baseline FEV1 was performed in triplicate using spirometry and the best of the 3 values was selected.|Pre-allergen baseline, 10, 20, 30, 45, 60, 90, 120, 180 minutes post-allergen inhalation Screening, Day 14, 35|ITT population included all randomized participants who received at least 1 dose administration of the test article.||percent drop||Standard Deviation|Mean
732422|NCT00410280|Secondary|Area Under the Percent Drop in Forced Expiratory Volume in 1 Second Curve (AUC FEV1) From Time 3 to 7 Hours for Late-Phase Asthma Response (LAR)|Allergen inhalation test was performed at Screening, Day 14 and 35 to elicit airway responses similar to those that follow natural allergen exposure. FEV1 was the maximal volume of air exhaled in 1 second of a forced expiration from a position of full inspiration. LAR was characterized by a fall in FEV1 of >=15% at 3 to 7 hours post-allergen inhalation. Area under the percent drop in FEV1 relative to the pre-allergen baseline FEV1 from 3 to 7 hours was computed using the linear trapezoidal rule. Pre-allergen baseline FEV1 was performed in triplicate using spirometry and the best of the 3 values was selected.|Pre-allergen baseline, 3, 4, 5, 6, 7 hours post-allergen inhalation at Screening (Day -14), Day 14, 35|ITT population included all randomized participants who received at least 1 dose administration of the test article.||Percent drop*hour||Standard Deviation|Mean
732423|NCT00410280|Primary|Maximum Percent Drop From Pre-allergen Baseline in Forced Expiratory Volume in 1 Second (FEV1) for Late-Phase Asthma Response (LAR) at Day 35|Allergen inhalation test was performed at Screening, Day 14 and 35 to elicit airway responses similar to those that follow natural allergen exposure. FEV1 was the maximal volume of air exhaled in 1 second of a forced expiration from a position of full inspiration. LAR was characterized by a fall in FEV1 of more than or equal to (>=) 15 percent (%) at 3 to 7 hours post-allergen inhalation. Maximum drop in FEV1 relative to the pre-allergen baseline FEV1 between 3 to 7 hours on Day 35 was reported. Pre-allergen baseline FEV1 was performed in triplicate using spirometry and the best of the 3 values was selected.|Pre-allergen baseline, 3, 4, 5, 6, 7 hours post-allergen inhalation at Day 35|ITT population included all randomized participants who received at least 1 dose administration of the test article.||percent drop||Standard Deviation|Mean
732424|NCT00410280|Primary|Maximum Percent Drop From Pre-allergen Baseline in Forced Expiratory Volume in 1 Second (FEV1) for Late-Phase Asthma Response (LAR) at Day 14|Allergen inhalation test was performed at Screening, Day 14 and 35 to elicit airway responses similar to those that follow natural allergen exposure. FEV1 was the maximal volume of air exhaled in 1 second of a forced expiration from a position of full inspiration. LAR was characterized by a fall in FEV1 of more than or equal to (>=) 15 percent (%) at 3 to 7 hours post-allergen inhalation. Maximum drop in FEV1 relative to the pre-allergen baseline FEV1 between 3 to 7 hours on Day 14 was reported. Pre-allergen baseline FEV1 was performed in triplicate using spirometry and the best of the 3 values was selected.|Pre-allergen baseline, 3, 4, 5, 6, 7 hours post-allergen inhalation at Day 14|ITT population included all randomized participants who received at least 1 dose administration of the test article.||percent drop||Standard Deviation|Mean
732425|NCT00410280|Primary|Maximum Percent Drop From Pre-allergen Baseline in Forced Expiratory Volume in 1 Second (FEV1) for Late-Phase Asthma Response (LAR) at Screening|Allergen inhalation test was performed at Screening, Day 14 and 35 to elicit airway responses similar to those that follow natural allergen exposure. FEV1 was the maximal volume of air exhaled in 1 second of a forced expiration from a position of full inspiration. LAR was characterized by a fall in FEV1 of more than or equal to (>=) 15 percent (%) at 3 to 7 hours post-allergen inhalation. Maximum drop in FEV1 relative to the pre-allergen baseline FEV1 between 3 to 7 hours at Screening was reported. Pre-allergen baseline FEV1 was performed in triplicate using spirometry and the best of the 3 values was selected.|Pre-allergen baseline, 3, 4, 5, 6, 7 hours post-allergen inhalation at Screening (Day -14)|ITT population included all randomized participants who received at least 1 dose administration of the test article.||percent drop||Standard Deviation|Mean
732426|NCT00403403|Secondary|Duration of Objective Response|Duration of response was defined as time from the first response date to disease progression or on-study death (i.e., death occurring any time from randomization to 30 days after the final treatment with bevacizumab/placebo). Objective response was defined as a complete or partial response (per RECIST) determined by two investigator assessments conducted at least 4 weeks apart.|Randomization until progression or lost to follow-up (up to 2 years)|Randomized patients with measurable disease at baseline.||Months||95% Confidence Interval|Median
732427|NCT00403403|Secondary|Number of Participants With an Objective Response|"Objective response was defined as a complete or partial response (per RECIST) determined by two investigator assessments conducted at least 4 weeks apart.
Complete Response (CR), Partial Response (PR), Incomplete Response (IR), Stable Disease (SD) (per RECIST):
Target Lesions Non-Target Lesions New Lesions Overall Response CR CR No CR CR IR/SD No PR PR Non-PD No PR"|Randomization until progression or lost to follow-up (up to 2 years)|||number of participants|||Number
732429|NCT00403403|Secondary|Overall Survival|Duration of overall survival from randomization until death or loss to follow-up|Randomization until death or lost of follow-up (up to 27 months)|Intent-to-treat population||Months||95% Confidence Interval|Median
734277|NCT00425269|Secondary|C-peptid, 2-h, Baseline||baseline|||pmol/L||95% Confidence Interval|Mean
732437|NCT00403455|Primary|Clinician Administered PTSD Scale (CAPS)|The CAPS assessment is used to determine the severity of an individuals PTSD. The assessment examines Re-experiencing, Avoidance and Numbing, and Hyperarousal symptoms which total score in each of these categories are added together to achieve a total CAPS score. Scores on this assessment can range from 0-136 with 0 not having any PTSD symptoms and 136 having the most symptoms possible. The study uses this assessment at the baseline and at the end of treatment to determine the decrease in this score over the course of the study.|12 weeks|All participants analyzed had a CAPS score of >45 and were DSM-IV positive for PTSD. Both males and females with backgrounds in all ethnic groups were aloud to participate in the study.||Change in units on a scale||Full Range|Mean
732438|NCT00403481|Secondary|Change in Ambulatory BP (Diastolic) From Baseline to Week 12 During the Last (Week 12 ) 4 and 6 Hours of the Last 24-hour Dosing Period.|Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.|baseline and 12 weeks|A total of 192 participants started. Eighteen dropped out. All Ambulatory Blood Pressure Monitoring (ABPM) Subjects (N=172) consisted of all subjects in the efficacy cohort who had a baseline and week 12 ABPM. Of the 172 ABPM participants, only 171 had the required measurements for this outcome analysis.||mm Hg||Standard Error|Mean
732439|NCT00403481|Secondary|Change in Ambulatory Blood Pressure (Diastolic) From Baseline to Week 12 During the Last 2 Hours of the Last (Week 12 ) 24-hour Dosing Period.|Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.|baseline and 12 Weeks|A total of 192 participants started. Eighteen dropped out. All Ambulatory Blood Pressure Monitoring (ABPM) Subjects (N=172) consisted of all subjects in the efficacy cohort who had a baseline and week 12 ABPM.Of the 172 participants, only 169 had the required measurements for this outcome analysis.||mm Hg||Standard Error|Mean
732440|NCT00403481|Secondary|Change in Daytime and Nighttime Ambulatory Blood Pressure (Diastolic) From Baseline to Week 12|Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.|baseline and 12 weeks|A total of 192 participants started. Eighteen dropped out. All Ambulatory Blood Pressure Monitoring (ABPM) Subjects (N=172) consisted of all subjects in the efficacy cohort who had a baseline and week 12 ABPM.||mm Hg||Standard Error|Mean
732441|NCT00403481|Secondary|Change From Baseline to Week 12 in Mean 24-hour Ambulatory BP (Diastolic)|Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.|baseline and 12 weeks|A total of 192 participants started. Eighteen dropped out. All Ambulatory Blood Pressure Monitoring (ABPM) Subjects (N=172) consisted of all subjects in the efficacy cohort who had a baseline and week 12 ABPM.||mm Hg||Standard Error|Mean
732442|NCT00403481|Secondary|Change From Baseline to Week 12 in Ambulatory BP Measurement (Systolic)During the Last 6 Hours of the Last (Week 12 ) 24-hour Dosing Period.|Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.|baseline and 12 weeks|A total of 192 participants started. Eighteen dropped out. All Ambulatory Blood Pressure Monitoring (ABPM) Subjects (N=172) consisted of all subjects in the efficacy cohort who had a baseline and week 12 ABPM. Of the 172 ABPM participants, only 171 had the required measurements||mm Hg||Standard Error|Mean
732443|NCT00403481|Secondary|Change From Baseline to Week 12 in Ambulatory BP Measurement (Systolic)During the Last 4 Hours of the Last (Week 12 ) 24-hour Dosing Period.|Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.|baseline and 12 weeks|A total of 192 participants started. Eighteen dropped out. All Ambulatory Blood Pressure Monitoring (ABPM) Subjects (N=172) consisted of all subjects in the efficacy cohort who had a baseline and week 12 ABPM.Of the 172 ABPM participants, only 171 had the required measurements for this outcome analysis.||mm Hg||Standard Error|Mean
732444|NCT00403481|Secondary|Change From Baseline to Week 12 in Ambulatory BP Measurement (Systolic)During the Last 2 Hours of the Last (Week 12) 24-hour Dosing Period.|Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.|baseline and 12 weeks|A total of 192 participants started. Eighteen dropped out. All Ambulatory Blood Pressure Monitoring (ABPM) Subjects (N=172) consisted of all subjects in the efficacy cohort who had a baseline and week 12 ABPM. Of the 172 ABPM participants, only 169 had the required measurements for this outcome analysis.||mm Hg||Standard Error|Mean
732445|NCT00403481|Secondary|Change From Baseline to Week 12 in Mean Daytime and Nighttime Ambulatory Blood Pressure Measurement (Systolic).|Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.|baseline and 12 weeks|A total of 192 participants started. Eighteen dropped out. All Ambulatory Blood Pressure Monitoring (ABPM) Subjects (N=172) consisted of all subjects in the efficacy cohort who had a baseline and week 12 ABPM.||mm Hg||Standard Error|Mean
732446|NCT00403481|Primary|Change From Baseline to Week 12 in Systolic BP (SBP) as Measured by 24-hour ABPM.|Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.|baseline and 12 weeks|A total of 192 participants started. Eighteen dropped out. All Ambulatory Blood Pressure Monitoring (ABPM) Subjects (N=172) consisted of all subjects in the efficacy cohort who had a baseline and week 12 ABPM.||mm Hg||Standard Error|Mean
732447|NCT00403546|Secondary|Change in Schizophrenia Cognition Rating Scale (SCoRS) Score|SCoRS is a 20 item interview-based clinical assessment that evaluates cognitive deficits and the degree to which these deficits impair participants’ day-to-day functioning. The following cognitive domains are assessed: attention, memory, working memory, language production, reasoning, problem solving, motor skills, and social cognition. Score ranges from 1 to 10 with a higher score indicating a greater degree of impairment. A negative change from baseline indicates an improvement.|Baseline, Week 8|All participants with available data at each time point.||units on a scale||Standard Deviation|Mean
734278|NCT00425269|Secondary|C-peptide, 0-h, Baseline||baseline|||pmol/L||95% Confidence Interval|Mean
732448|NCT00403546|Secondary|Change From Baseline in Global Assessment of Functioning (GAF) Score|GAF is a numeric scale used to rate social, occupational, and psychological functioning of participants. Scores range from 100 (extremely high functioning) to 1 (severely impaired). A positive change from baseline indicates an improvement.|Baseline, Week 8|All participants with available data at each time point.||units on a scale||Standard Deviation|Mean
732449|NCT00403546|Secondary|Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Score|CGI-I is a 7 point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to baseline. Score ranges from 1 to 7 with a higher score indicating a worse outcome. A negative change from baseline indicates an improvement.|Baseline, Week 8|All participants with available data at each time point.||units on a scale||Standard Deviation|Mean
732450|NCT00403546|Secondary|Change From Baseline in Clinical Global Impression- Severity (CGI-S) Score|CGI-S is a 7-point scale that requires the clinician to rate the severity of the participant's illness at the time of assessment, relative to the clinician's past experience with subjects who have the same diagnosis. Score ranges from 1 to 7 with a higher score indicating a worse outcome. A negative change from baseline indicates an improvement.|Baseline, Week 8|All participants with available data at each time point.||units on a scale||Standard Deviation|Mean
732451|NCT00403546|Secondary|Change From Baseline in the Calgary Depression Rating Scale (CDRS) Total Score|The CDRS was used to assess the level of depression in participants with schizophrenia. The questionnaire consists of 9 questions rated on a 4-point scale from 0 to 3. Total range is 0 to 27 with a higher score indicating a worse outcome. A negative change from baseline indicates an improvement.|Baseline, Week 2, Week 4, Week 6, Week 8|All participants with available data at each time point.||units on a scale||Standard Deviation|Mean
732452|NCT00403546|Secondary|Change From Baseline in PANSS Negative Subscale Score|The PANSS is a medical scale and was used for measuring symptom severity of participants with schizophrenia in this study. Negative symptoms as defined by the American Psychiatric Association represent a diminution or loss of normal functions and include the following 7 items: blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation and stereotyped thinking. Score ranges from 7 to 49 with a higher score indicating a worse outcome. A negative change from baseline indicates an improvement.|Baseline, Week 2, Week 4, Week 6, Week 8|All participants with available data at each time point.||units on a scale||Standard Deviation|Mean
732453|NCT00403546|Secondary|Change From Baseline in Positive Subscale Score of PANSS|The PANSS is a medical scale and was used for measuring symptom severity of participants with schizophrenia in this study. Positive symptoms as defined by the American Psychiatric Association refer to an excess or distortion of normal functions and include the following 7 items: delusions, conceptual disorganization, hallucinations, excitement, grandiosity, suspiciousness/persecution and hostility. Score ranges from 7 to 49 with a higher score indicating a worse outcome. A negative change from baseline indicates an improvement.|Baseline, Week 2, Week 4, Week 6, Week 8|All participants with available data at each time point.||units on a scale||Standard Deviation|Mean
732454|NCT00403546|Primary|Number of Treatment-emergent Adverse Events During Randomized Trial|Adverse event: any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. Serious adverse event (SAE): significant hazard, contraindication, side effect, or precaution, which fulfilled any of the following criteria: fatal (resulted in death), life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was medically significant or required intervention to prevent any of the other outcomes listed here.|From Baseline up to Week 8|Safety population includes all participants who received at least one dose of study medication.||adverse events|||Number
732455|NCT00403546|Primary|Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Score|AIMS is a rating scale measuring involuntary movements known as tardive dyskinesia, that sometimes develop as a side effect of long-term treatment with antipsychotic medications. The AIMS score was calculated as the sum of questions 1 through 7 of the AIMS instrument, which includes assessments of involuntary movements in the face, lips, jaw, tongue, upper and lower extremities, and neck/shoulders/hips. Each item is rated on a five-point scale of severity from 0–4 with 0 (none), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe). Total scores range from 0 to 28. A negative change from baseline indicates an improvement.|Baseline, Week 2, Week 4, Week 6, Week 8|All participants with available data at each time point.||units on a scale||Standard Deviation|Mean
732456|NCT00403546|Primary|Percentage of Participants With Response|Response was defined as a reduction in the PANSS total score from baseline by 20% or greater, calculated by first subtracting 30 (the PANSS minimum possible total score). Response rate is the percentage of participants with a response.|Baseline, Week 2, Week 4, Week 6, Week 8|All participants with available data at each time point||percentage of participants|||Number
732457|NCT00403546|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score|The PANSS is a medical scale and was used for measuring symptom severity of participants with schizophrenia in this study. Total PANSS score consists of 7 items in the Negative subscale, 7 items in the Positive subscale and 16 items in the General Psychopathology scale. Total PANSS score ranges from 30 to 210. A higher score indicates a worse outcome. A negative change from baseline indicates an improvement.|Baseline, Week 2, Week 4, Week 6, Week 8|All participants with available data at each time point.||units on a scale||Standard Deviation|Mean
732458|NCT00403546|Primary|Electrocardiogram (EKG): Number of Participants With an Increase From Baseline to Corrected QT (QTc) Interval >/= 500 Milliseconds (Msec)|QT interval is a measure of the time between the start of the Q wave and the end of the T wave as determined by electrocardiogram (EKG). The corrected QT Interval (QTc) adjusts the QT interval for heart rate. The number of participants with an increase to QTc interval >/= 500 msec was reported.|6 hours after dosing of Weeks 1, 2 and 8|All participants with available data at each time point.||participants|||Number
733341|NCT00410813|Secondary|Change in Serum Bone Turnover Markers Over Time -- OPG|Analysis included mean values of the serum biomarker OPG at baseline, 4, and 8 weeks.|at baseline, 4, and 8 weeks|Number of patients with samples to analyze: baseline n=66, 4 weeks n=54, 8 weeks n=52.||pmol/L||Standard Deviation|Mean
732459|NCT00403546|Primary|Vital Signs: Systolic and Diastolic Blood Pressure Levels|Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured at regular times during the study. Normal SBP is defined as 120 millimeters of mercury (mmHg) or below and normal DBP is defined as 80 mmHg or below. Change from baseline is indicated for each time point. A positive change from baseline indicates and increase in blood pressure and a negative change from baseline indicates a decrease.|Baseline, Week 1, Week 2, Week 4, Week 6, Week 8|All participants with available data at each time point.||mmHg||Standard Deviation|Mean
732460|NCT00403546|Primary|Number of Participants With High and Low Levels in Serum Prolactin Concentration|Blood samples were taken at baseline and Week 8 to measure serum prolactin concentrations. Normal range for females (non-pregnant) is 2-29 nanograms per deciliter (ng/dL) and for males 2-18 ng/dL. Values above the normal range were reported as High and values below the normal range were reported as Low. Reported here is the number of participants with high prolactin concentration and the number of participants with low prolactin concentration.|Baseline, Week 8|All participants with available data at each time point.||participants|||Number
732461|NCT00403546|Primary|Change From Baseline in the Barnes Akathisia Scale (BAS)|BAS is a rating scale that is administered by physicians to assess the severity of drug-induced akathisia, which is a movement disorder characterized by a feeling of inner restlessness and a compelling need to be in constant motion, as well as by actions such as rocking while standing or sitting, lifting the feet as if marching on the spot, and crossing and uncrossing the legs while sitting. The following subcategories are scored: objective akathisia, subjective awareness of restlessness and subjective distress related to restlessness and are rated on a 4-point scale from 0 – 3. In addition, the global clinical assessment of akathisia uses a 6-point scale ranging from 0 – 5. Total score ranges from 0 to 14 with a higher score indicating increased severity. A positive change from baseline indicates a worse outcome.|Baseline, Week 2, Week 4, Week 6, Week 8|All participants who had available data at each time point.||units on a scale||Standard Deviation|Mean
732462|NCT00403546|Primary|Change From Baseline in Simpson Angus Scale for Extrapyramidal Symptoms (SAS)|The SAS is a 10-item testing instrument used to evaluate drug-related extrapyramidal syndromes. The following items are included in the SAS: gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, leg pendulousness, head dropping, glabella reflex, tremor, and salivation. Total score ranges from 0 to 40 with a higher score indicating increased severity. A positive change from baseline indicates a worse outcome.|Baseline, Week 2, Week 4, Week 6, Week 8|All study participants with available data at each time point.||units on a scale||Standard Deviation|Mean
732463|NCT00403546|Primary|Number of Events Recorded Based on Ziprasidone Side Effects Checklist During Randomized Trial|Side effects were tracked using the Side Effect Checklist for ziprasidone, which is a well-validated 17 item scale that records the presence or absence of side effects. Total number of side effect events is reported here.|From Baseline up to Week 8|All participants in the randomized trial.||side effect events|||Number
732464|NCT00410384|Other Pre-specified|Adverse Event (AE) Overview|SEE ALSO ADVERSE EVENT RESULTS SECTION|Up to 80 Weeks|||Percentage of participants|||Number
732465|NCT00410384|Secondary|Percent of Subjects Whose Average Prednisone Dose Has Been Reduced by ≥ 25% From Baseline to ≤ 7.5 mg/Day During Weeks 40 Through 52||Baseline, Weeks 40-52|Analysis was performed on a MITT population, defined as all subjects who were randomized and received at least 1 dose of study agent. Includes only subjects with baseline prednisone dose > 7.5 mg/day.||Percentage of participants|||Number
732466|NCT00410384|Secondary|Mean Change From Baseline in Medical Outcomes 36-Item Short Form Health Survey (SF-36) Physical Component Summary Score (PCS) at Week 24.|The SF-36 is a generic health related quality of life (HRQOL) measurement. The survey includes 36 questions grouped to 8 domains and 2 summary measures (physical and mental health component, PCS and MCS, respectively) assessing HRQOL. Responses are scored according to the SF-36v2™ manual. A score is calculated for each SF-36 domain based on the patient’s response to each question within it. This is then transformed to a scale ranging from 0 (worst) to 100 (best) points. The PCS is norm-based where the mean=50 and standard deviation (SD)=10. Higher scores represent better physical health.|Baseline, 24 Weeks|Analysis was performed on a MITT population, defined as all subjects who were randomized and received at least 1 dose of study agent.||Scores on a scale||Standard Error|Mean
732467|NCT00410384|Secondary|Mean Change in Physician's Global Assessment (PGA) at Week 24.|The PGA is a visual analog scale scored from 0 to 3. A score of 1 corresponds to mild lupus disease activity. A score of 2 correlates with moderate disease activity and a score of 3 with severe disease activity.|Baseline, 24 Weeks|Analysis was performed on a MITT population, defined as all subjects who were randomized and received at least 1 dose of study agent.||Scores on a 3-point scale||Standard Error|Mean
732468|NCT00410384|Secondary|Percent of Subjects With a ≥ 4 Point Reduction From Baseline in SELENA SLEDAI Score at Week 52.||Baseline, 52 Weeks|Analysis was performed on a MITT population, defined as all subjects who were randomized and received at least 1 dose of study agent.||Percentage of participants|||Number
732469|NCT00410384|Secondary|SRI Response Rate at Week 76|"Percentage of subjects with a ≥ 4 point reduction from baseline in SELENA SLEDAI score, and no worsening (increase of < 0.30 points from baseline) in PGA, and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with baseline.
SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare. PGA is a visual analog scale scored from 0 to 3 (1=mild, 2=moderate, 3=severe). BILAG uses a single score for each of the 8 organ domains; range is from severe to no disease (A to E)."|Baseline, 76 Weeks|Analysis was performed on a MITT population, defined as all subjects who were randomized and received at least 1 dose of study agent. Subjects who required rescue SLE medications were declared nonresponders, as were subjects who dropped out or were missing Week 76 data.||Percentage of participants|||Number
732479|NCT00410410|Secondary|OL; Number of Participants With Clinical Response Over Time|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. A clinical response is defined as a reduction from baseline in the Mayo score of ≥ 3 points and ≥ 30%, with an accompanying decrease in the rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point.|Day OL-1 through Day OL-729|All participants who received at least 1 infusion of open-label study medication at any time were included in the efficacy analyses of the OL. Number of Participants Analyzed=all participants in OL; n=number of evaluable participants.||participants|||Number
732470|NCT00410384|Primary|SLE Responder Index (SRI) Response Rate at Week 52|"Percentage of subjects with a ≥ 4 point reduction from baseline in SELENA SLEDAI score, and no worsening (increase of < 0.30 points from baseline) in PGA, and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with baseline.
SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare. PGA is a visual analog scale scored from 0 to 3 (1=mild, 2=moderate, 3=severe). BILAG uses a single score for each of the 8 organ domains; range is from severe to no disease (A to E)."|Baseline, 52 Weeks|Analysis was performed on a modified intention-to-treat (MITT) population, defined as all subjects who were randomized and received at least 1 dose of study agent. Subjects who required rescue SLE medications were declared nonresponders, as were subjects who dropped out or were missing Week 52 data.||Percentage of participants|||Number
732471|NCT00410410|Secondary|OL; Number of Participants Using Corticosteroids During OL|Participants taking oral corticosteroids (equivalent of ≤ 30 mg prednisone daily) must have met minimum treatment duration at entry into IP and had stable dose for ≥2 weeks prior to entry into the IP.|Day OL-1 through Day OL-729|Due to the early termination of the study after preliminary IP1C results were reviewed and the primary efficacy endpoint was not achieved, the secondary subgroup analyses of corticosteroid use was not conducted for the OL as planned.|||||
732472|NCT00410410|Secondary|OL; Number of Participants With Abatacept-Induced Antibodies|A electrochemiluminescent immunoassay screened sera for drug-specific antibodies, immunocompetition was used to identify specific anti-Abatacept reactivity. CTLA4 and Possibly Ig category=reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing.|For participants receiving OL medication, all measurements starting after Day OL-1 (including follow-up visits and at 56 and 85 days after last dose)|"All subjects with at least one post-baseline immunogenicity measurement during the study period were included in the immunogenicity data set. Positive was defined as positive post-baseline IP-1 and with a titer value greater than the baseline titer value. Participants with missing baseline titer were assumed negative at baseline."||participants|||Number
732473|NCT00410410|Secondary|OL; Number of Participants With Clinical Response or Clinical Remission Upon Retreatment With Abatacept Among Those Who Received Abatacept in the IP or MP Period|The Mayo Scoring system (range 0-12 points, high scores=greater severity of disease) is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Clinical response=reduction from baseline in the Mayo score of ≥ 3 points and ≥ 30%, with accompanying decrease in the rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point. Clinical remission = Mayo score of ≤ 2 points with no individual subscore exceeding 1 point. Change from Baseline= post-Baseline - Baseline value.|Last Study Visit (Day OL-729)|Due to the early termination of the study after preliminary IP1C results were reviewed and the primary efficacy endpoint was not achieved, the secondary subgroup analyses of clinical efficacy upon retreatment with abatacept among participants who received study drug during the IP or MP was not conducted for the OL as planned.|||||
732474|NCT00410410|Secondary|OL; Number of Participants With Mayo Endoscopic Subscores Indicating Mucosal Healing (≤1 Point) During OL|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. Mucosal healing was defined as endoscopic subscore ≤ 1 point|Open-Label Period (Day OL-1 through Day OL-729)|Due to the early termination of the study after preliminary IP1C results were reviewed and the primary efficacy endpoint was not achieved, the secondary subgroup analyses of mucosal healing was not conducted for the OL as planned.||participants|||Number
732475|NCT00410410|Primary|OL; Number of Participants With Chemistry and Urinalysis Laboratory Abnormalities|Low=lower than LLN, High=greater than ULN. LLN/ULN= serum glucose (Glu): <65 mg/dL/ >220 mg/dL; fasting serum Glu: <0.8 x LLN/ >1.5 x ULN; total protein: < 0.9 x LLN/ >1.1 x ULN; albumin:<0.9 x LLN; uric acid: >1.5 x ULN. For Urinalysis (Urine protein, urine Glu, urine blood, leukocyte esterase, Red Blood Cells [RBCs], White Blood Cells [WBCs]): Use ≥2 when BL value missing or value ≥4, or when pre-dose=0 or 0.5. Use ≥3 when pre-dose=1. Use ≥4 when pre-dose=2 or 3|Day OL-1 through Day OL-729|The As Treated analysis population was used for all safety summaries and was defined to include all participants who received at least one infusion of study medication.||participants|||Number
732476|NCT00410410|Primary|OL; Number of Participants With Liver and Kidney Function and Electrolyte Laboratory Abnormalities|Low=lower than LLN, High=greater than ULN. LLN/ULN= Alkaline phosphatase (ALP): >2 x ULN; aspartate aminotransferase (AST): >3 x ULN; alanine aminotransferase (ALT): >3 x ULN; G-Glutamyl transferase (GGT): >2 x ULN; Bilirubin: >2 x ULN; blood urea nitrogen (BUN): >2 x BL; creatinine: >4 x BL; potassium (K): <0.9 x LLN/ >1.1 x ULN; calcium (Ca): <0.8 x LLN/>1.2 x ULN; phosphorous (P): <0.75 x LLN/ >1.2 5 x ULN|Day OL-1 through Day OL-729|The As Treated analysis population was used for all safety summaries and was defined to include all participants who received at least one infusion of study medication.||participants|||Number
732477|NCT00410410|Primary|OL; Number of Participants With Marked Hematology Laboratory Abnormalities|High=greater than Upper Normal Limit (ULN), Low=lower than Lower Normal Limit (LLN). LLN/ULN= Hemoglobin (HGB): >3 g/dL decrease from Baseline (BL); Hematocrit: <0.75 x BL; Erythrocytes: <0.75 x BL; Platelets (PLT): <0.67 x LLN/>1.5 x ULN; Leukocytes: <0.75 x LLN/ >1.25 x ULN; neutrophils+bands: <1.0 x 10^3 c/uL; eosinophils: >0.750 x 10^3 c/uL; monocytes: >2000 mm3; lymphocytes: <0.750 x 10^3 c/uL/ >7.50 x 10^3 c/uL.|Day OL-1 through Day OL-729|The As Treated analysis population was used for all safety summaries and was defined to include all participants who received at least one infusion of study medication.||participants|||Number
732478|NCT00410410|Secondary|OL; Number of Participants With Clinical Remission Over Time|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. Clinical remission is defined as a Mayo score of ≤ 2 points with no individual subscore exceeding 1 point.|Day OL-1 through Day OL-729|All participants who received at least 1 infusion of open-label study medication at any time were included in the efficacy analyses of the OL. Number of Participants Analyzed=all participants in OL; n=number of evaluable participants.||participants|||Number
732480|NCT00410410|Primary|OL; Number of Participants With Physical Examination Findings|Complete physical examination was obtained at the Screening Visit, Day MP-365, and OL Final Visit/Early Termination visits. Interim physical examinations were performed at other study visits. Interim physical exam were not as comprehensive as the initial full examination but did note any changes in the participant's condition since the last assessment and did not preclude examination of any of the body systems as clinically indicated. Participants were observed for AEs and vital signs (blood pressure, heart rate, and temperature).|Day OL-1 through Day OL-729|As the results of this study were presented in a synoptic report, physical examination evaluations were not summarized. Laboratory abnormalities and vital signs were collected and summarized.|||||
732481|NCT00410410|Secondary|MP; Number of Participants With Marked Chemistry and Urinalysis Laboratory Abnormalities|Low=lower than LLN, High=greater than ULN. LLN/ULN= serum glucose (Glu): <65 mg/dL/ >220 mg/dL; fasting serum Glu: <0.8 x LLN/ >1.5 x ULN; total protein: < 0.9 x LLN/ >1.1 x ULN; albumin:<0.9 x LLN; uric acid: >1.5 x ULN. For Urinalysis (Urine protein, urine Glu, urine blood, leukocyte esterase, Red Blood Cells [RBCs], White Blood Cells [WBCs]): Use ≥2 when BL value missing or value ≥4, or when pre-dose=0 or 0.5. Use ≥3 when pre-dose=1. Use ≥4 when pre-dose=2 or 3|Day IP-85 through Day MP-365|The As Treated analysis population was used for all safety summaries and was defined to include all participants who received at least one infusion of study medication.||participants|||Number
732482|NCT00410410|Secondary|MP; Number of Participants With Marked Hematology Laboratory Abnormalities|High=greater than ULN, Low=lower than LLN. LLN/ULN= HGB: >3 g/dL decrease from Baseline (BL); Hematocrit: <0.75 x BL; Erythrocytes: <0.75 x BL; PLT: <0.67 x LLN/>1.5 x ULN; Leukocytes: <0.75 x LLN/ >1.25 x ULN; neutrophils+bands: <1.0 x 10^3 c/uL; eosinophils: >0.750 x 10^3 c/uL; monocytes: >2000 mm3; lymphocytes: <0.750 x 10^3 c/uL/ >7.50 x 10^3 c/uL; GGT: >2 x ULN; Bilirubin: >2 x ULN; BUN: >2 x BL; Na: <0.95 x LLN/ >1.05 x ULN; K: <0.9 x LLN/ >1.1 x ULN; Ca: <0.8 x LLN/>1.2 x ULN|Day IP-85 through Day MP-365|The As Treated analysis population was used for all safety summaries and was defined to include all participants who received at least one infusion of study medication.||participants|||Number
732483|NCT00410410|Secondary|MP; Number of Participants With Physical Examination Findings|Complete physical examination was obtained at the Screening Visit, Day MP-365, and OL Final Visit/Early Termination visits. Interim physical examinations were performed at other study visits. Interim physical exam were not as comprehensive as the initial full examination but did note any changes in the participant's condition since the last assessment and did not preclude examination of any of the body systems as clinically indicated. Participants were observed for AEs and vital signs (blood pressure, heart rate, and temperature).|Day IP-85 through Day MP-365|As the results of this study were presented in a synoptic report, physical examination evaluations were not summarized. Laboratory abnormalities and vital signs were collected and summarized.|||||
732484|NCT00410410|Secondary|MP; Number of Participants With AEs of Special Interest|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).|Day MP-1 through Day MP-365|The As Treated analysis population was used for all safety summaries and was defined to include all participants who received at least one infusion of study medication.||participants|||Number
732485|NCT00410410|Secondary|MP; Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and AEs Leading to Discontinuation|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|Day MP-1 through Day MP-365|The As Treated analysis population was used for all safety summaries and was defined to include all participants who received at least one infusion of study medication.||participants|||Number
732486|NCT00410410|Secondary|MP; Number of Participants With Abatacept-Induced Antibodies|A electrochemiluminescent immunoassay screened sera for drug-specific antibodies, immunocompetition was used to identify specific anti-Abatacept reactivity. CTLA4 and Possibly Ig category=reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing.|For participants not entering OL: All measurements starting after Day MP-1 (including follow-up visits). For participants entering OL: From first measurement after Day MP-1 to Day MP-365 (Day OL-1).|"All subjects with at least one post-baseline immunogenicity measurement during the study period were included in the immunogenicity data set. Positive was defined as positive post-baseline IP-1 and with a titer value greater than the baseline titer value. Participants with missing baseline titer were assumed negative at baseline."||participants|||Number
732487|NCT00410410|Secondary|MP; Number of Participants With Clinical Mucosal Healing at Month 12 Among Participants With Inadequate Response/Intolerance to Prior Anti-TNF Therapy (Infliximab)|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician’s Global Assessment). Higher Mayo scores indicate greater severity of disease. Mucosal healing was defined as endoscopic subscore ≤1 point. Inadequate response/intolerance = inadequate response/intolerance to an approved anti-TNF agent prior to this study at an approved labeled dose for ≥8 weeks.|Month 12 (Day MP-365)|Due to the early termination of the study after preliminary IP1C results were reviewed and the primary efficacy endpoint was not achieved, the secondary subgroup analyses of mucosal healing in subjects who have had an inadequate response and/or intolerance to anti-TNF therapy was not conducted for the MP as planned.|||||
733342|NCT00410813|Secondary|Change in Serum Bone Turnover Markers Over Time -- OC|Analysis included mean values of the serum biomarker OC at baseline, 4, and 8 weeks.|at baseline, 4, and 8 weeks|Number of patients with samples to analyze: baseline n=66, 4 weeks n=54, 8 weeks n=52.||ng/mL||Standard Deviation|Mean
732488|NCT00410410|Secondary|MP; Number of Participants With Clinical Remission at Month 12 Among Participants With Inadequate Response/Intolerance to Prior Anti-TNF Therapy (Infliximab)|The Mayo Scoring system (range 0-12 points, high scores=greater severity of disease) is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Clinical remission is defined as a Mayo score of ≤ 2 points with no individual subscore exceeding 1 point. Inadequate response/intolerance =inadequate response/intolerance to an approved anti-TNF agent prior to this study at an approved labeled dose for ≥8 weeks.|Month 12 (Day MP-365)|Due to the early termination of the study after preliminary IP1C results were reviewed and the primary efficacy endpoint was not achieved, the secondary subgroup analyses of clinical remission in subjects who have had an inadequate response and/or intolerance to anti-TNF therapy was not conducted for the MP as planned.|||||
732489|NCT00410410|Secondary|MP; Number of Participants With Clinical Response at Month 12 Among Participants With Inadequate Response/Intolerance to Prior Anti-TNF Therapy (Infliximab)|The Mayo Scoring system (range 0-12 points, high scores=greater severity of disease) is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Clinical response=reduction from baseline in the Mayo score of ≥ 3 points and ≥ 30%, with accompanying decrease in the rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point. Inadequate response/intolerance=inadequate response/intolerance to an approved anti-TNF agent prior to this study at an approved labeled dose for ≥8 weeks.|Month 12 (Day MP-365)|Due to the early termination of the study after preliminary IP1C results were reviewed and the primary efficacy endpoint was not achieved, the secondary subgroup analyses of clinical response in subjects who have had an inadequate response and/or intolerance to anti-TNF therapy was not conducted for the MP as planned.|||||
732490|NCT00410410|Secondary|MP; Number of Participants With Mayo PGA Subscores Indicating Mild Disease (≤1 Point) at Month 12|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. An absolute PGA subscore of ≤1 point was indicative of mild disease.|Day MP-365 (Month 12)|Due to the early termination of the study after preliminary IP1C results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analysis to determine the percentage of participants with PGA subscores indicating mild disease (≤1) was not conducted for the MP as planned.|||||
732491|NCT00410410|Secondary|MP; Number of Participants With Mayo Stool Frequency Subscores Indicating Mild Disease (≤1 Point) at Month 12|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. An absolute stool frequency subscore of ≤1 point was indicative of mild disease.|Day MP-365 (Month 12)|Due to the early termination of the study after preliminary IP1C results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analysis to determine the percentage of participants with stool frequency subscores indicating mild disease (≤1) was not conducted for the MP as planned.|||||
732492|NCT00410410|Secondary|MP; Number of Participants With Mayo Rectal Bleeding Subscores Indicating Mild Disease (≤1 Point) at Month 12|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. An absolute rectal bleeding subscore of ≤1 point was indicative of mild disease.|Day MP-365 (Month 12)|Due to the early termination of the study after preliminary IP1C results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analysis to determine the percentage of participants with rectal subscores indicating mild disease (≤1) was not conducted for the MP as planned.|||||
732493|NCT00410410|Secondary|MP; Number of Participants With Baseline Oral Corticosteroid Use Who Have Discontinued Corticosteroids for 90 Consecutive Days and Achieved Clinical Remission by Month 12|Baseline corticosteroids equivalent of ≤30 mg prednisone daily. The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater frequency or severity. Clinical remission is defined as a Mayo score of ≤ 2 points with no individual subscore exceeding 1 point.|Day MP-365 (Month 12)|Due to the early termination of the study after preliminary IP1C results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analyses for corticosteroid sparing were not conducted for the MP as planned.|||||
732494|NCT00410410|Secondary|MP; Mean Change From Baseline to Month 12 in Short Form-36 (SF-36)|The SF-36 is a validated instrument to measure health-related quality of life across multiple disease states. Individual subscale scores and 2 summary scores are calculated: (1) physical component summary (PCS) which includes physical functioning, role-physical, bodily pain, and general health; (2) mental component summary (MCS) which includes vitality, social functioning, role-emotional, and mental health. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight, with values ranging from worse health (0) to best health (100).|Day MP-365|Due to the early termination of the study after preliminary IP1C results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analysis for changes from baseline in SF-36 responses were not conducted for the MP as planned.|||||
732495|NCT00410410|Secondary|MP; Mean Change From Baseline to Month 12 in IBDQ|The Inflammatory Bowel Disease Questionnaire (IBDQ) was used to measure disease specific quality of life. The IBDQ consists of a self-administered 32-item questionnaire that evaluates quality of life across 4 dimensional scores: Bowel, Systemic, Social and Emotional. The response to each question can range from 1 to 7, with 1 indicating severe problem and 7 indicating normal health. The total IBDQ is computed as the sum of the responses to the individual IBDQ questions. The total score can range between 32 to 224 with higher scores indicating a better quality of life.|Day MP-365|Due to the early termination of the study after preliminary IP1C results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analysis for changes from baseline in IBDQ responses were not conducted for the MP as planned.|||||
733343|NCT00410813|Secondary|Change in Serum Bone Turnover Markers Over Time|Analysis included mean values of the serum biomarkers sRANKL, IL-6, DKK, VEGF at baseline, 4, and 8 weeks.|at baseline, 4, and 8 weeks|Number of patients with samples to analyze: baseline n=66, 4 weeks n=54, 8 weeks n=52.||pg/mL||Standard Deviation|Mean
732496|NCT00410410|Secondary|MP; Number of Participants With Baseline Oral Corticosteroid Use Who Have Discontinued Corticosteroids and Achieved Clinical Remission by Month 12|Baseline corticosteroids equivalent of ≤30 mg prednisone daily. The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician’s Global Assessment). Higher Mayo scores indicate greater frequency or severity. Clinical remission is defined as a Mayo score of ≤ 2 points with no individual subscore exceeding 1 point.|Day MP-365 (Month 12)|Due to the early termination of the study after preliminary IP1C results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analyses for corticosteroid sparing were not conducted for the MP as planned.|||||
732497|NCT00410410|Secondary|MP; Number of Participants in Clinical Remission at Both Month 6 and Month 12|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. Clinical remission is defined as a Mayo score of ≤ 2 points with no individual subscore exceeding 1 point.|Month 6 (Day MP-169), Month 12 (Day MP-365)|Due to the early termination of the study after preliminary IP1C results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analysis to determine the percentage of participants in clinical remission at both Month 6 and Month 12 was not conducted for the MP as planned.|||||
732498|NCT00410410|Secondary|MP; Number of Participants With Mayo Endoscopic Subscores Indicating Mucosal Healing (≤1 Point) at Month 12|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician’s Global Assessment). Higher Mayo scores indicate greater severity of disease. Mucosal healing was defined as endoscopic subscore ≤ 1 point|Month 12 (Day MP-365)|All participants in the ITT Population were included in the efficacy analyses. Participants with missing Mayo score were defined as not having achieved clinical response, remission, or mucosal healing.||participants|||Number
732499|NCT00410410|Secondary|MP; Number of Participants in Clinical Remission at Month 12|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. Clinical remission is defined as a Mayo score of ≤ 2 points with no individual subscore exceeding 1 point.|Month 12 (Day MP-365)|All participants in the ITT Population were included in the efficacy analyses. Participants with missing Mayo score were defined as not having achieved clinical response, remission, or mucosal healing.||participants|||Number
732500|NCT00410410|Secondary|IP; Number of Participants With Abatacept-Induced Antibodies: IP1C + IP2C|A electrochemiluminescent immunoassay screened sera for drug-specific antibodies, immunocompetition was used to identify specific anti-Abatacept reactivity. CTLA4 and Possibly Ig category=reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing.|For participants treated in MP: Day IP-1 (Baseline) to Day MP-1 (Day IP-85). For participants treated in OL directly after IP: Day IP-1 to Day OL-1. For participants treated only in IP: All measurements after Day IP-1 (including follow-up visits)|"All subjects with at least one post-baseline immunogenicity measurement during the study period were included in the immunogenicity data set. Positive was defined as positive post-baseline IP-1 and with a titer value greater than the baseline titer value. Participants with missing baseline titer were assumed negative at baseline."||participants|||Number
732501|NCT00410410|Secondary|IP; Number of Participants With Marked Chemistry and Urinalysis Laboratory Abnormalities: IP2C|Low=lower than LLN, High=greater than ULN. LLN/ULN= serum glucose (Glu): <65 mg/dL/ >220 mg/dL; total protein: < 0.9 x LLN/ >1.1 x ULN; albumin:<0.9 x LLN. For Urinalysis (Urine protein, urine Glu, urine blood, leukocyte esterase, Red Blood Cells [RBCs], White Blood Cells [WBCs]): Use ≥2 when BL value missing or value ≥4, or when pre-dose=0 or 0.5. Use ≥3 when pre-dose=1. Use ≥4 when pre-dose=2 or 3|Day IP-1 through Day IP-85|The As Treated analysis population was used for all safety summaries and was defined to include all participants who received at least one infusion of study medication.||participants|||Number
732502|NCT00410410|Secondary|IP; Number of Participants With Marked Hematology, Liver and Kidney Function, and Electrolyte Laboratory Abnormalities: IP2C|High=greater than Upper Normal Limit (ULN), Low=lower than Lower Normal Limit (LLN). LLN/ULN= Hemoglobin (HGB): >3 g/dL decrease from Baseline (BL); Hematocrit: <0.75 x BL; Erythrocytes: <0.75 x BL; Platelets (PLT): <0.67 x LLN/>1.5 x ULN; Leukocytes: <0.75 x LLN/ >1.25 x ULN; eosinophils: >0.750 x 10^3 c/uL; monocytes: >2000 mm3; lymphocytes: <0.750 x 10^3 c/uL/ >7.50 x 10^3 c/uL; blood urea nitrogen (BUN): >2 x BL; creatinine: >4 x BL; Sodium (Na): <0.95 x LLN/ >1.05 x ULN; potassium (K): <0.9 x LLN/ >1.1 x ULN; phosphorous (P): <0.75 x LLN/ >1.2 5 x ULN;|Day IP-1 through Day IP-85|The As Treated analysis population was used for all safety summaries and was defined to include all participants who received at least one infusion of study medication.||participants|||Number
732503|NCT00410410|Secondary|IP; Number of Participants With Marked Chemistry and Urinalysis Laboratory Abnormalities: IP1C|Low=lower than LLN, High=greater than ULN. LLN/ULN= serum glucose (Glu): <65 mg/dL/ >220 mg/dL; total protein: < 0.9 x LLN/ >1.1 x ULN; albumin:<0.9 x LLN; uric acid: >1.5 x ULN. For Urinalysis (Urine protein, urine Glu, urine blood, leukocyte esterase, Red Blood Cells [RBCs], White Blood Cells [WBCs]): Use ≥2 when BL value missing or value ≥4, or when pre-dose=0 or 0.5. Use ≥3 when pre-dose=1. Use ≥4 when pre-dose=2 or 3|Day IP-1 through Day IP-85|The As Treated analysis population was used for all safety summaries and was defined to include all participants who received at least one infusion of study medication.||participants|||Number
732504|NCT00410410|Secondary|IP; Number of Participants With Marked Liver and Kidney Function and Electrolyte Laboratory Abnormalities: IP1C|Low=lower than LLN, High=greater than ULN. LLN/ULN= Alkaline phosphatase (ALP): >2 x ULN; aspartate aminotransferase (AST): >3 x ULN; alanine aminotransferase (ALT): >3 x ULN; G-Glutamyl transferase (GGT): >2 x ULN; Bilirubin: >2 x ULN; blood urea nitrogen (BUN): >2 x BL; creatinine: >4 x BL; Sodium (Na): <0.95 x LLN/ >1.05 x ULN; potassium (K): <0.9 x LLN/ >1.1 x ULN; calcium (Ca): <0.8 x LLN/>1.2 x ULN; phosphorous (P): <0.75 x LLN/ >1.2 5 x ULN|Day IP-1 through Day IP-85|The As Treated analysis population was used for all safety summaries and was defined to include all participants who received at least one infusion of study medication.||participants|||Number
734279|NCT00425269|Secondary|HbA1c, Baseline||baseline|||percent of Hb||95% Confidence Interval|Mean
732505|NCT00410410|Secondary|IP; Number of Participants With Marked Hematology Laboratory Abnormalities: IP1C|High=greater than Upper Normal Limit (ULN), Low=lower than Lower Normal Limit (LLN). LLN/ULN= Hemoglobin (HGB): >3 g/dL decrease from Baseline (BL); Hematocrit: <0.75 x BL; Erythrocytes: <0.75 x BL; Platelets (PLT): <0.67 x LLN/>1.5 x ULN; Leukocytes: <0.75 x LLN/ >1.25 x ULN; neutrophils+bands: <1.0 x 10^3 c/uL; eosinophils: >0.750 x 10^3 c/uL; monocytes: >2000 mm3; lymphocytes: <0.750 x 10^3 c/uL/ >7.50 x 10^3 c/uL.|Day IP-1 through Day IP-85|The As Treated analysis population was used for all safety summaries and was defined to include all participants who received at least one infusion of study medication.||participants|||Number
732506|NCT00410410|Secondary|IP; Number of Participants With Physical Examination Findings: IP1C + IP2C|Complete physical examination was obtained at the Screening Visit, Day MP-365, and OL Final Visit/Early Termination visits. Interim physical examinations were performed at other study visits. Interim physical exam were not as comprehensive as the initial full examination but did note any changes in the participant's condition since the last assessment and did not preclude examination of any of the body systems as clinically indicated. Participants were observed for AEs and vital signs (blood pressure, heart rate, and temperature).|Day IP-1 through Day IP-85|As the results of this study were presented in a synoptic report, physical examination evaluations were not summarized. Laboratory abnormalities and vital signs were collected and summarized.|||||
732507|NCT00410410|Secondary|IP; Number of Participants With AEs Of Special Interest: IP1C + IP2C|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).|Day IP-1 through Day IP-85|The As Treated analysis population was used for all safety summaries and was defined to include all participants who received at least one infusion of study medication.||participants|||Number
732508|NCT00410410|Secondary|IP; Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and AEs Leading to Discontinuation: IP1C + IP2C|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|Day IP-1 through Day IP-85|The As Treated analysis population was used for all safety summaries and was defined to include all participants who received at least one infusion of study medication.||participants|||Number
732509|NCT00410410|Secondary|IP; Number of Participants in Mucosal Healing at Week 12 Among Participants With Anti-TNF (Infliximab) Failure/Intolerance: IP1C|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician’s Global Assessment). Higher Mayo scores indicate greater severity of disease. Mucosal healing was defined as endoscopic subscore ≤ 1 point. Inadequate response/intolerance = inadequate response/intolerance to an approved anti-TNF agent prior to this study at an approved labeled dose for ≥8 weeks.|Week 12 (Day IP-85)|All participants in ITT Population were included in the efficacy analyses. Participants with missing Mayo score were defined as not having achieved clinical response, remission, or mucosal healing. Prior inadequate response/intolerance was to an approved anti-TNF agent at an approved labeled dose for ≥8 weeks.||participants|||Number
732510|NCT00410410|Primary|OL; Number of Participants With AEs of Special Interest|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).|Day OL-1 through Day OL-729|All participants who received at least 1 infusion of open-label study medication at any time were included in the safety analyses of the Open-Label Extension phase.||participants|||Number
732511|NCT00410410|Primary|Open-Label Extension Period (OL); Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and AEs Leading to Discontinuation|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|Day OL-1 through the end of the OL|All participants who received at least 1 infusion of open-label study medication at any time were included in the safety analyses of the Open-Label Extension phase.||participants|||Number
732512|NCT00410410|Secondary|IP; Number of Participants in Clinical Remission at Week 12 Among Participants With Anti-TNF (Infliximab) Failure/Intolerance: IP1C|"The Mayo Scoring system (range 0-12 points, high scores=greater severity of disease) is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Clinical remission is defined as a Mayo score of ≤ 2 points with no individual subscore exceeding 1 point. Inadequate response/intolerance
=inadequate response/intolerance to an approved anti-TNF agent prior to this study at an approved labeled dose for ≥8 weeks."|Week 12 (Day IP-85)|All participants in ITT Population were included in the efficacy analyses. Participants with missing Mayo score were defined as not having achieved clinical response, remission, or mucosal healing. Prior inadequate response/intolerance was to an approved anti-TNF agent at an approved labeled dose for ≥8 weeks.||participants|||Number
732545|NCT00410605|Secondary|Effect of Bev/Rev on Markers of Myeloma Activity in Myeloma Cells and Stromal Cells at 3 Months Post-baseline|A Wilconxon signed-rank test conducted to determine if biomarker levels differed between baseline levels and those after three full cycles of treatment for all patients.|Up to Course 4 Day 1 (3 Months Post-baseline)|||mg per liter||Standard Deviation|Mean
732513|NCT00410410|Primary|Maintenance Period (MP); Number of Participants With Clinical Response (Per Mayo Score) at Month 12|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. A clinical response is defined as a reduction from baseline in the Mayo score of ≥ 3 points and ≥ 30%, with an accompanying decrease in the rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point.|Month 12 (Day MP-365)|All participants in the ITT Population were included in the efficacy analyses. Participants with missing Mayo score were defined as not having achieved clinical response, remission, or mucosal healing.||participants|||Number
732514|NCT00410410|Secondary|IP; Number of Participants With Clinical Response At Week 12 Among Participants With Anti-TNF (Infliximab) Failure/Intolerance: IP1C|The Mayo Scoring system (range 0-12 points, high scores=greater severity of disease) is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Clinical response=reduction from baseline in the Mayo score of ≥ 3 points and ≥ 30%, with accompanying decrease in the rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point. Inadequate response/intolerance=inadequate response/intolerance to an approved anti-TNF agent prior to this study at an approved labeled dose for ≥8 weeks.|Week 12 (Day IP-85)|All participants in ITT Population were included in the efficacy analyses. Participants with missing Mayo score were defined as not having achieved clinical response, remission, or mucosal healing. Prior inadequate response/intolerance was to an approved anti-TNF agent at an approved labeled dose for ≥8 weeks.||participants|||Number
732515|NCT00410410|Secondary|IP; Number of Participants Who Are Anti-TNF-Inadequate Responders/Anti-TNF Intolerant With Clinical Response At Week 12 Analyzed by Cochran-Armitage Trend Test for Dose-Response Relationship: IP1C|The Mayo Scoring system (range 0-12 points, high scores=greater severity of disease) is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Clinical response=reduction from baseline in the Mayo score of ≥ 3 points and ≥ 30%, with accompanying decrease in the rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point. Inadequate response/intolerance=inadequate response/intolerance to an approved anti-TNF agent prior to this study at an approved labeled dose for ≥8 weeks.|Week 12 (Day IP-85)|All participants in ITT Population were included in the efficacy analyses. Participants with missing Mayo score were defined as not having achieved clinical response, remission, or mucosal healing. Prior inadequate response/intolerance was to an approved anti-TNF agent at an approved labeled dose for ≥8 weeks.||participants|||Number
732516|NCT00410410|Secondary|IP; Number of Participants With Mayo Physician Global Assessment (PGA) Subscores Indicating Mild Disease (≤1 Point) at Week 12: IP1C|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician’s Global Assessment). Higher Mayo scores indicate greater severity of disease. An absolute PGA subscore of ≤1 point was indicative of mild disease.|Day IP-85 (Week 12)|All participants in the ITT Population were included in the efficacy analyses. Participants with missing Mayo score were defined as not having achieved clinical response, remission, or mucosal healing.||participants|||Number
732517|NCT00410410|Secondary|IP; Number of Participants With Mayo Stool Frequency Subscores Indicating Mild Disease (≤1 Point) at Week 12: IP1C|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician’s Global Assessment). Higher Mayo scores indicate greater severity of disease. An absolute stool frequency subscore of ≤1 point was indicative of mild disease.|Day IP-85 (Week 12)|All participants in the ITT Population were included in the efficacy analyses. Participants with missing Mayo score were defined as not having achieved clinical response, remission, or mucosal healing.||participants|||Number
732518|NCT00410410|Secondary|IP; Number of Participants With Mayo Rectal Bleeding Subscores Indicating Mild Disease (≤1 Point) at Week 12: IP1C|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician’s Global Assessment). Higher Mayo scores indicate greater severity of disease. An absolute rectal bleeding subscore of ≤1 point was indicative of mild disease.|Day IP-85 (Week 12)|All participants in the ITT Population were included in the efficacy analyses. Participants with missing Mayo score were defined as not having achieved clinical response, remission, or mucosal healing.||participants|||Number
732519|NCT00410410|Secondary|IP; Mean Change From Baseline To Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ): IP1C|The Inflammatory Bowel Disease Questionnaire (IBDQ) was used to measure disease specific quality of life. The IBDQ consists of a self-administered 32-item questionnaire that evaluates quality of life across 4 dimensional scores: Bowel, Systemic, Social and Emotional. The response to each question can range from 1 to 7, with 1 indicating severe problem and 7 indicating normal health. The total IBDQ is computed as the sum of the responses to the individual IBDQ questions. The total score can range between 32 to 224 with higher scores indicating a better quality of life.|Baseline (Day IP-1), Day IP-85 (Week 12)|All participants in the ITT Population were included in the efficacy analyses. Participants with missing Mayo score were defined as not having achieved clinical response, remission, or mucosal healing.||units on a scale||Standard Error|Mean
732520|NCT00410410|Secondary|IP; Baseline Inflammatory Bowel Disease Questionnaire (IBDQ) Score: IP1C|The Inflammatory Bowel Disease Questionnaire (IBDQ) was used to measure disease specific quality of life. The IBDQ consists of a self-administered 32-item questionnaire that evaluates quality of life across 4 dimensional scores: Bowel, Systemic, Social and Emotional. The response to each question can range from 1 to 7, with 1 indicating severe problem and 7 indicating normal health. The total IBDQ is computed as the sum of the responses to the individual IBDQ questions. The total score can range between 32 to 224 with higher scores indicating a better quality of life.|Baseline|The As Treated analysis population was used for all safety summaries and was defined to include all participants who received at least one infusion of study medication.||units on a scale||Standard Deviation|Mean
732546|NCT00410605|Secondary|Local Cytokine Milieu Using Tissue Micro Arrays of Bone Marrow Biopsy Specimens||Up to 5 years|Outcome measure data were not collected.|||||
732547|NCT00410605|Secondary|Effect of Bev/Rev on Markers of Myeloma Activity in Myeloma Cells and Stromal Cells at Baseline|A Wilconxon signed-rank test conducted to determine if biomarker levels differed between baseline levels and those after three full cycles of treatment for all patients.|Baseline|||mg per liter||Standard Deviation|Mean
732521|NCT00410410|Secondary|IP; Number of Participants With Clinical Response (Per Mayo Score) at Week 12 Analyzed by Cochran-Armitage Trend Test for Dose-Response Relationship: IP1C|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. A clinical response is defined as a reduction from baseline in the Mayo score of ≥ 3 points and ≥ 30%, with an accompanying decrease in the rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point.|Week 12 (Day IP-85)|All participants in the ITT Population were included in the efficacy analyses. Participants with missing Mayo score were defined as not having achieved clinical response, remission, or mucosal healing.||participants|||Number
732522|NCT00410410|Secondary|IP; Number of Participants in Mucosal Healing (Per Mayo Score) at Week 12: IP1C|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician’s Global Assessment). Higher Mayo scores indicate greater severity of disease. Mucosal healing was defined as endoscopic subscore ≤ 1 point|Week 12 (Day IP-85)|All participants in the ITT Population were included in the efficacy analyses. Participants with missing Mayo score were defined as not having achieved clinical response, remission, or mucosal healing.||participants|||Number
732523|NCT00410410|Secondary|IP; Number of Participants in Clinical Remission (Per Mayo Score) at Week 12: IP1C|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician’s Global Assessment). Higher Mayo scores indicate greater severity of disease. Clinical remission is defined as a Mayo score of ≤ 2 points with no individual subscore exceeding 1 point.|Week 12 (Day IP-85)|All participants in the ITT Population were included in the efficacy analyses. Participants with missing Mayo score were defined as not having achieved clinical response, remission, or mucosal healing.||participants|||Number
732524|NCT00410410|Secondary|IP; Baseline Mayo Score: IP1C|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. A clinical response is defined as a reduction from baseline in the Mayo score of ≥ 3 points and ≥ 30%, with an accompanying decrease in the rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point.|Baseline|The As Treated analysis population was used for all safety summaries and was defined to include all participants who received at least one infusion of study medication.||units on a scale||Standard Deviation|Mean
732525|NCT00410410|Primary|Induction Period (IP); Number of Participants With Clinical Response (Per Mayo Score) at Week 12: IP Cohort 1 (IP1C)|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician’s Global Assessment). Higher Mayo scores indicate greater severity of disease. A clinical response is defined as a reduction from baseline in the Mayo score of ≥ 3 points and ≥ 30%, with an accompanying decrease in the rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point.|Week 12 (Day IP-85)|All participants who were randomized and received at least one infusion of study medication (Intent To Treat Population, ITT) were included in the efficacy analyses. Participants with missing Mayo score were defined as not having achieved clinical response, remission, or mucosal healing.||participants|||Number
732526|NCT00410488|Primary|Palonosetron Response Rate in the 10 Day Study Cycle|Number of participants with dose of palonosetron who experienced response (no emesis) during acute and delayed time period of the study (10 days) divided by number of participants. Complete response defined as no emesis and no rescue medicines in 10 days from the start of chemotherapy in the first chemotherapy cycle.|10 days|||percentage of participants|||Number
732527|NCT00410514|Secondary|Change From Baseline to Weeks 4, 8, 12 and End of Treatment in International Consultation on Incontinence Questionnaire - Lower Urinary Tract Symptom Quality of Life (ICIQ-LUTSqol) Overall Symptom Interference of Life Score|"Participants were asked to rate how much their urinary symptoms interfered overall with their everyday life on a scale from 0 (not at all) to 10 (a great deal).
Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate."|Baseline and Weeks 4, 8 and 12|The Full Analysis Set included all patients who received at least 1 dose of double-blind study drug & had both Qmax & PdetQmax measurements at baseline & 1 or both at any postbaseline on-treatment visit. End of treatment (EOT) includes the last on-treatment assessment for patients who didn't complete Week 12; N is the number of patients included.||scores on a scale||Standard Error|Least Squares Mean
732528|NCT00410514|Secondary|Change From Baseline to Weeks 4, 8, 12 and End of Treatment in International Consultation on Incontinence Questionnaire - Lower Urinary Tract Symptom Quality of Life (ICIQ-LUTSqol) Symptom Score|"Quality of life was assessed by the ICIQ-LUTSqol questionnaire which consists of 19 questions each on a 1-4 scale (larger scores correspond to less quality of life). The total symptom score ranges from 19 - 76.
Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate."|Baseline and Weeks 4, 8 and 12|The Full Analysis Set included all patients who received at least 1 dose of double-blind study drug & had both Qmax & PdetQmax measurements at baseline & 1 or both at any postbaseline on-treatment visit. End of treatment (EOT) includes the last on-treatment assessment for patients who didn't complete Week 12; N is the number of patients included.||scores on a scale||Standard Error|Least Squares Mean
732529|NCT00410514|Secondary|Change From Baseline to Weeks 4, 8, 12 and End of Treatment in International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptom (ICIQ MLUTS) Total Bother Score|"The degree to which urinary symptoms bothered participants was assessed by the ICIQ MaleLUTS questionnaire which consists of 13 symptom bother questions each on a 0-10 scale (larger scores correspond to worse outcomes). The total bother score ranges from 0 to 130.
Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate."|Baseline and Weeks 4, 8 and 12|The Full Analysis Set included all patients who received at least 1 dose of double-blind study drug & had both Qmax & PdetQmax measurements at baseline & 1 or both at any postbaseline on-treatment visit. End of treatment (EOT) includes the last on-treatment assessment for patients who didn't complete Week 12; N is the number of patients included.||scores on a scale||Standard Error|Least Squares Mean
734280|NCT00425269|Primary|Plasma Glucose 2 h After Oral Glucose Tolerance Test, Baseline||baseline|||mmol/L||95% Confidence Interval|Mean
732530|NCT00410514|Secondary|Change From Baseline to Weeks 4, 8, 12 and End of Treatment in International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptom (ICIQ MLUTS) Total Symptom Score|"Male lower urinary tract symptoms were assessed by the ICIQ MaleLUTS questionnaire which consists of 13 questions each on a 0-4 scale (larger scores correspond to worse conditions). The total symptom score ranges from 0 to 52.
Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate."|Baseline and Weeks 4, 8 and 12|The Full Analysis Set included all patients who received at least 1 dose of double-blind study drug & had both Qmax & PdetQmax measurements at baseline & 1 or both at any postbaseline on-treatment visit. End of treatment (EOT) includes the last on-treatment assessment for patients who didn't complete Week 12; N is the number of patients included.||scores on a scale||Standard Error|Least Squares Mean
732531|NCT00410514|Secondary|Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Mean Voided Volume Per Micturition|"The mean volume voided per micturition was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate."|Baseline and Weeks 1, 4, 8 and 12|The Full Analysis Set included all patients who received at least 1 dose of double-blind study drug & had both Qmax & PdetQmax measurements at baseline & 1 or both at any postbaseline on-treatment visit. End of treatment (EOT) includes the last on-treatment assessment for patients who didn't complete Week 12; N is the number of patients included.||mL||Standard Error|Least Squares Mean
732532|NCT00410514|Secondary|Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours|"The mean number of incontinence episodes (the involuntary leakage of urine) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate."|Baseline and Weeks 1, 4, 8 and 12|Full Analysis Set included all patients who received at least 1 dose of double-blind study drug & had both Qmax & PdetQmax measurements at Baseline & 1 or both at any postbaseline on-treatment visit. The analysis only includes patients with >0 incontinence episodes at baseline. End of treatment (EOT) includes patients who didn't complete Week 12.||Incontinence episodes||Standard Error|Least Squares Mean
732533|NCT00410514|Secondary|Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Mean Number of Urgency Episodes With Urgency Severity ≥ 3 Per 24 Hours|"For each micturition and/or incontinence episode in the 3 days preceding the clinic visit, participants rated the degree of associated urgency (the sudden compelling desire to pass urine, which is difficult to defer) according to the following scale: 0: No Urgency, felt no need to empty my bladder but did so for another reason; 1: Mild Urgency, could postpone passing water for as long as necessary; 2: Moderate Urgency, could postpone passing water for a short while; 3: Severe Urgency, could not postpone passing water; 4: Urge Incontinence, leaked before reaching the toilet.
Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate."|Baseline and Weeks 1, 4, 8 and 12|The Full Analysis Set included all patients who received at least 1 dose of double-blind study drug & had both Qmax & PdetQmax measurements at baseline & 1 or both at any postbaseline on-treatment visit. End of treatment (EOT) includes the last on-treatment assessment for patients who didn't complete Week 12; N is the number of patients included.||Urgency episodes||Standard Error|Least Squares Mean
732534|NCT00410514|Secondary|Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Mean Number of Micturitions Per 24 Hours|"A micturition is any voluntary urination, excluding episodes of incontinence only. The mean number of micturitions per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate."|Baseline and Weeks 1, 4, 8 and 12|The Full Analysis Set included all patients who received at least 1 dose of double-blind study drug & had both Qmax & PdetQmax measurements at baseline & 1 or both at any postbaseline on-treatment visit. End of treatment (EOT) includes the last on-treatment assessment for patients who didn't complete Week 12; N is the number of patients included.||micturitions||Standard Error|Least Squares Mean
732535|NCT00410514|Secondary|Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Patient Perception of Bladder Condition (PPBC)|"The patient perception of bladder condition (PPBC) asks participants to assess their bladder condition using a 6-point validated Likert scale which ranges from 1 (does not cause me any problems at all) to 6 (causes me many severe problems).
Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate."|Baseline and Weeks 1, 4, 8 and 12|The Full Analysis Set included all patients who received at least 1 dose of double-blind study drug & had both Qmax & PdetQmax measurements at baseline & 1 or both at any postbaseline on-treatment visit. End of treatment (EOT) includes the last on-treatment assessment for patients who didn't complete Week 12; N is the number of patients included.||scores on a scale||Standard Error|Least Squares Mean
732536|NCT00410514|Secondary|Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in International Prostate Symptoms Score (IPSS) Storage Symptom Score|"The IPSS is a validated global questionnaire used to assess the degree of “bother” from benign prostatic hyperplasia symptoms based on the answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The storage symptom score is the sum of the responses to 3 questions relating to storage symptoms (frequency, urgency and nocturia) and ranges from 0 to 15 (asymptomatic to very symptomatic).
Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate."|Baseline and Weeks 1, 4, 8 and 12|The Full Analysis Set included all patients who received at least 1 dose of double-blind study drug & had both Qmax & PdetQmax measurements at baseline & 1 or both at any postbaseline on-treatment visit. End of treatment (EOT) includes the last on-treatment assessment for patients who didn't complete Week 12; N is the number of patients included.||scores on a scale||Standard Error|Least Squares Mean
732566|NCT00411216|Secondary|Eye Movements: Scleral Search Coil|eye movements are measured by having the participant sit within an electromagnetic field while wearing a scleral coil (like a contact lens but only in contact with the sclea, not the cornea); te coil moves with eye movement and distorts the electrimagnetic field|pre- and post-treatment||||||
732567|NCT00411216|Secondary|Fall Risk (Dynamic Gait Index)|performance test|pre-intervention, 2 weeks, 4 weeks and at discharge||||||
732537|NCT00410514|Secondary|Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in International Prostate Symptoms Score (IPSS) Voiding Score|"The IPSS is a validated global questionnaire used to assess the degree of “bother” from benign prostatic hyperplasia symptoms based on the answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The voiding score is the sum of the responses to 4 questions relating to urination (incomplete emptying, intermittency, weak stream and straining) and ranges from 0 to 20 (asymptomatic to very symptomatic).
Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate."|Baseline and Weeks 1, 4, 8 and 12|The Full Analysis Set included all patients who received at least 1 dose of double-blind study drug & had both Qmax & PdetQmax measurements at baseline & 1 or both at any postbaseline on-treatment visit. End of treatment (EOT) includes the last on-treatment assessment for patients who didn't complete Week 12; N is the number of patients included.||scores on a scale||Standard Error|Least Squares Mean
732538|NCT00410514|Secondary|Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in International Prostate Symptoms Score (IPSS) Total Score|"The IPSS is a validated global questionnaire used to assess the degree of “bother” from benign prostatic hyperplasia symptoms and is based on the answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).
Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate."|Baseline and Weeks 1, 4, 8 and 12|The Full Analysis Set included all patients who received at least 1 dose of double-blind study drug & had both Qmax & PdetQmax measurements at baseline & 1 or both at any postbaseline on-treatment visit. End of treatment (EOT) includes the last on-treatment assessment for patients who didn't complete Week 12; N is the number of patients included.||scores on a scale||Standard Error|Least Squares Mean
732539|NCT00410514|Secondary|Safety Assessed by Adverse Events (AEs), Electrocardiogram (ECG), Vital Signs, Physical Exam and Laboratory Tests|Abnormal laboratory parameters, vital signs or ECG data were defined as AEs if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. A serious AE was an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important. AEs were assessed by the Investigator for intensity as mild, moderate or severe and for causal relationship to study drug.|From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).|The Safety Analysis set included all participants who received at least one dose of study drug.||participants|||Number
732540|NCT00410514|Secondary|Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Postvoid Residual Volume (PVR)|"Healthy micturitions (urinations) result in complete emptying of the bladder. Post Void Residual (PVR) is the volume of urine retained after voiding and was assessed using abdominal ultrasound. An increasing PVR over time is an indicator of abnormal bladder function or detrusor decompensation.
Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate."|Baseline and Weeks 1, 4, 8 and 12|The Safety Analysis set included all participants who received at least one dose of study drug. End of treatment (EOT) analysis includes the last assessment for patients who did not complete the Week 12 visit; N indicates the number of patients included at each time point.||mL||Standard Error|Least Squares Mean
732541|NCT00410514|Secondary|Change From Baseline to End of Treatment in Bladder Voiding Efficiency (BVE)|"Bladder Voiding Efficiency (BVE) is a product of bladder contractility against the urethral resistance and is measured according to the degree of bladder emptying. BVE is expressed as a percentage and is calculated using the formula:
Bladder Voiding efficiency = (Voided volume x 100)/maximum cystometric capacity.
A higher number indicates a higher voiding efficiency. Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate."|Baseline and Week 12|The Full Analysis Set included all patients who received at least 1 dose of double-blind study drug & had both Qmax & PdetQmax measurements at Baseline & 1 or both at any postbaseline on-treatment visit. Data include the last on-treatment assessment for patients who did not complete the Week 12 visit.||Percent voiding efficiency||Standard Error|Least Squares Mean
732542|NCT00410514|Primary|Change From Baseline to End of Treatment in Detrusor Pressure at Maximum Flow Rate (PdetQmax)|"Detrusor pressure at maximum urinary flow rate (PdetQmax) was measured by the Investigator using cystometry and was sent to an independent central reading center for review and interpretation.
Least squares means (LSM) were derived from an analysis of covariance (ANCOVA) model with the pooled study center and treatment as factors and the baseline value as a covariate."|Baseline and Week 12|The Full Analysis Set included all patients who received at least 1 dose of double-blind study drug & had both Qmax & PdetQmax measurements at Baseline & 1 or both at any postbaseline on-treatment visit. Data include the last on-treatment assessment for patients who did not complete the Week 12 visit.||cmH2O||Standard Error|Least Squares Mean
732543|NCT00410514|Secondary|Change From Baseline to End of Treatment in Bladder Contractile Index (BCI)|"The Bladder Contractile Index (BCI) is a value used to measure the degree of contractility. BCI was calculated using the following formula:
BCI = pdetQmax + 5Qmax.
Strong contractility is a BCI > 150, normal contractility is a BCI of 100-150 and weak contractility is a BCI of < 100.
Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate."|Baseline and Week 12|The Full Analysis Set included all patients who received at least 1 dose of double-blind study drug & had both Qmax & PdetQmax measurements at Baseline & 1 or both at any postbaseline on-treatment visit. Data include the last on-treatment assessment for patients who did not complete the Week 12 visit.||Scores on a scale||Standard Error|Least Squares Mean
732544|NCT00410514|Primary|Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax)|"Maximum urinary flow rate (Qmax) was measured by the Investigator using cystometry and was sent to an independent central reading center for review and interpretation.
Least squares means (LSM) were derived from an analysis of covariance (ANCOVA) model with the pooled study center and treatment as factors and the baseline value as a covariate."|Baseline and Week 12|The Full Analysis Set included all patients who received at least 1 dose of double-blind study drug & had both Qmax & PdetQmax measurements at Baseline & 1 or both at any postbaseline on-treatment visit. Data include the last on-treatment assessment for patients who did not complete the Week 12 visit.||mL/sec||Standard Error|Least Squares Mean
732548|NCT00410605|Secondary|Toxicity and Tolerability of the Bevacizumab and Lenalidomide Combination|Adverse events/toxicities were collected during regular clinical visits. Confidence intervals for the estimate of the true number of patients suffereing from grade 3 or 4 toxicities per common terminology criteria were calculated using the Wilson interval. Ninety-five percent confidence intervals for the proportions of patients with complications (grade 3 or higher toxicities) were constructed.|Up to 5 years|||percentage of participants||95% Confidence Interval|Number
732549|NCT00410605|Primary|Progression Free Survival (Time to Progression)|Patient response to the treatment were determined by the definitions for complete response, partial response, marginal response, stable disease, and progressive disease outlined by IMBTR/ABMTR (Blade criteria). Progression free survival was summarized using point estimates of the median time to progression and associated 95% confidence intervals. The data was presented graphically using Kaplan-Meier plots. Exploratory analysis, including multivariate Cox regression with demographic variables and markers of myeloma activity as covariates was performed.|up to five years|||months||95% Confidence Interval|Median
732550|NCT00410605|Primary|Confirmed Anti-tumor Response Rate (Complete Response and Partial Response) to the Combination of Bevacizumab and Lenalidomide|Patient response to the treatment were determined by the definitions for complete response, partial response, marginal response, stable disease, and progressive disease outlined by IMBTR/ABMTR (Blade criteria). Responses were analyzed by descriptive statistics and summarized in tabular format (frequency tables). Furthermore, two-sided 95% confidence intervals for the proportions of subjects with a confirmed anti-tumor response were computed using the method proposed by Chang, which takes into account the multiplicity problem associated with the two-stage testing procedure. The objective response rate was estimated by using Whitehead's bias-adjustment approach.|Up to 5 years|||percentage of participants||95% Confidence Interval|Number
732551|NCT00410826|Secondary|Progression Free Survival of Patients With Locally Advanced Head and Neck Cancer Treated With Cisplatin and Radiotherapy, With and Without Erlotinib Hydrochloride|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Every 3 months for up to 5 years|||participants|||Number
732552|NCT00410826|Secondary|Safety as Assessed Through Summaries of Adverse Events and Laboratory Test Results by Treatment Arm||30 days after the completion of therapy||||||
732553|NCT00410826|Primary|Comparison of the Percentage of Participants With a Complete Response in Each Treatment Arm|Complete response requires both a pathological complete response (independent of observer) and a complete response radiologically (RECIST 1.0).|12 weeks after the completion of therapy|||percentage of participants|||Number
732554|NCT00410891|Primary|Positive Culture||2|||percentage of patients|||Number
732555|NCT00410891|Primary|Conjunctival Bacterial Flora|number of bacteria on the conjunctiva|3 days||||||
732556|NCT00410904|Secondary|Overall Survival|Estimated with the standard Kaplan-Meier method, from which summary statistics of interest (median, 1-year rate, etc.) will be derived. Both point and 95% confidence interval estimates of all PFS and OS statistics will be calculated.|The time from start of treatment to time of death, assessed up to 4 years||||||
732557|NCT00410904|Secondary|Progression-free Survival|Estimated with the standard Kaplan-Meier method, from which summary statistics of interest (median, 1-year rate, etc.) will be derived. Both point and 95% confidence interval estimates of all PFS and OS statistics will be calculated.|The duration of time from start of treatment to time of progression, assessed up to 4 years||||||
732558|NCT00410904|Primary|Response Rate (Complete and Partial) 2 Separate Cohorts of Relapsed NSCLC Cohort A: Pts Who Have Received Prior Chemo w/o Ever Having Received Bevacizumab. Cohort B: Pts Who Have Received Prior Bevacizumab.|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v 1.0) for target lesions and assessed by MRI or CT:
Complete Response (CR): Disappearance of all target lesions
Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD
Overall Response (OR) = CR + PR, the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started)"|Up to 4 years|||participants|||Number
732559|NCT00411151|Secondary|Safety and Tolerability: Adverse Events in ≥10% of Patients||one year|Safety population comprises all patients registered.||Participants|||Number
732560|NCT00411151|Secondary|Safety and Tolerability: Serious Adverse Events|The number of participants with at least one Serious Adverse Event was measured.|one year|Safety population comprises all patients registered.||Participants|||Number
732561|NCT00411151|Secondary|Adverse Events|The number of participants with at least one adverse event was measured.|one year|Safety population comprises all patients registered.||Participants|||Number
732562|NCT00411151|Secondary|One-Year Survival|One-year survival is defined as the percentage of participants surviving for at least one year after first dose of trial medication.|one year|Intention-to-treat (ITT) population comprises all patients registered, except one patient whose tumor diagnosis was not confirmed.||Participants (%)||95% Confidence Interval|Number
732563|NCT00411151|Secondary|Overall Survival (OS)|OS is defined as the time from the first dose of trial medication to date of death due to any cause.|one year|Intention-to-treat (ITT) population comprises all patients registered, except one patient whose tumor diagnosis was not confirmed.||Days||95% Confidence Interval|Median
732564|NCT00411151|Secondary|Progression-Free Survival (PFS)|PFS is defined as the time from first dose of trial medication to first documentation of objective tumor progression or to death due to any cause, whichever occurs first.|one year|Intention-to-treat (ITT) population comprises all patients registered, except one patient whose tumor diagnosis was not confirmed.||Days||95% Confidence Interval|Median
732565|NCT00411151|Primary|Objective Response Rate (ORR)|The primary endpoint is the ORR within the first 6 treatment cycles, defined as the percentage of participants with a confirmed reduction in tumor size fulfilling the criteria for complete or partial response (CR or PR) according to RECIST. CR=disappearance of all target lesions, PR=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions|one year|Intention-to-treat (ITT) population comprises all patients registered, except one patient whose tumor diagnosis was not confirmed.||Participants (%)||95% Confidence Interval|Number
732568|NCT00411216|Secondary|Balance and Gait|gait speed|pre-intervention, 2 weeks, 4 weeks and at discharge||||||
736588|NCT00443040|Secondary|Time to First Passage of Flatus||Daily for 38 days||||||
732573|NCT00411216|Primary|Change in Visual Acuity During Head Movement From Baseline to Discharge|"visual acuity is measured using a computerized system first with the head stationary and then with the head moving in yaw plane. Head velocity is measured using a rate sensor and optotype is displayed only when head velocity is between 120 and 180 degrees per second.
The change in visual acuity was calculated from subtracting the discharge measurement from the baseline measurement (pre-intervention)."|pre-intervention and at discharge|||LogMAR||Standard Deviation|Mean
732574|NCT00411398|Primary|Hamilton Anxiety Scale|Standard Clinical Depression Rating Scale. Clinician administered. Scale units are points/numbers. Possible range is 0 to 44 with the latter signifying more severe anxiety|10 wk|LOCF if at least one post baseline visit completed||units on a scale||Standard Deviation|Mean
732575|NCT00411411|Secondary|Examination of GLP-2, Somatostatin, Glucagon, Peptide-YY and Two Glycaemic Control Parameters (HbA1c and Fasting Plasma Glucose)|Secondary objectives are examination of GLP-2, somatostatin, glucagon, peptide-YY and two glycaemic control parameters (HbA1c and fasting plasma glucose). Patients will be followed for 12 weeks with three examinations; before, during and after the treatment|12 weeks||||||
732576|NCT00411411|Primary|Restoration of the Insulinotropic Effect of GIP|Restoration of the insulinotropic effect of GIP measured as the relative increase in GIP induced amplification of the late phase insulin secretion (AUC) response to glucose. Patients will be followed for 12 weeks with examinations after 1 and after 12 weeks of treatment.|12 weeks|||pM x 120 min||Standard Error|Mean
732577|NCT00411411|Primary|the Relative Increase in Meal-induced Total GLP-1 Secretion|Patients will be followed for 12 weeks with three meal test examinations; before treatment, after 1 week of treatment and after 12 weeks of treatment. Primary outcome is AUC GLP-1 (pM x 120 as stated).|12 weeks|||pM x 120 min||Standard Deviation|Mean
732578|NCT00411450|Secondary|Number of Participants Who Developed Antibodies to Panitumumab|The immunogenicity of panitumumab was evaluated using 2 different screening immunoassays for the detection of anti-panitumumab antibodies: an acid dissociation bridging enzyme-linked immunosorbent assay (ELISA; detecting high-affinity antibodies) and a Biacore® biosensor immunoassay (detecting both high and low-affinity antibodies). When either of the 2 screening assays yielded a positive result, that particular sample was subjected to an in vitro bioassay for the detection of neutralizing antibodies.|Prior to first dose and 28 days after the last dose of second-line treatment|Safety Analysis Set with baseline anti-panitumumab antibody testing sample available||participants|||Number
732579|NCT00411450|Secondary|Number of Participants With Grade 4 Laboratory Toxicities|Laboratory toxicities were graded according to CTCAE version 3.|From the first dose date to 30 days after the last dose date. The median time frame is 4.5 months.|Safety Analysis Set||participants|||Number
732580|NCT00411450|Primary|Time to Response|Time to response of second-line treatment is defined as the time from study Day 1 to the date of first documentation of CR or PR, calculated for those participants with an objective tumor response of CR or PR.|Tumor response was assessed at Weeks 9, 17, 25, and 33, and once every 12 weeks thereafter until the end of second-line treatment; maximum time on treatment was 77 weeks.|Responders in the Tumor Response Analysis Set||weeks||Full Range|Median
732581|NCT00411450|Primary|Time to Progression|Time to progression is defined as the time from study Day 1 to the date of observed disease progression. Time to progression was analyzed using Kaplan-Meier methods; participants who did not have disease progression were censored at the date of last evaluable tumor assessment.|From Study Day 1 until the data cut-off date of 2 January 2009; median follow-up time was 39 weeks, with a maximum of 93 weeks.|Primary Analysis Set||weeks||95% Confidence Interval|Median
732582|NCT00411450|Primary|Time to Treatment Failure|Time to failure of second-line treatment is defined as the time from study Day 1 to the date of the earliest of the following events: end of second-line therapy due to any reason except for complete response and curative surgery; progressive disease; or death due to any cause. Time to treatment failure was analyzed using Kaplan-Meier methods; participants who did not discontinue second-line treatment or discontinue due to complete response or curative surgery, who were still alive, and who did not have disease progression were censored at the date of the last contact.|Tumor response was assessed at Weeks 9, 17, 25, and 33, and once every 12 weeks thereafter until the end of second-line treatment; maximum time on treatment was 77 weeks.|Primary Analysis Set||weeks||95% Confidence Interval|Median
732583|NCT00411450|Primary|Overall Survival|Overall survival is defined as as the number of days from Study Day 1 to the date of death due to any cause. Overall survival was analyzed using the Kaplan-Meier method; participants who were lost to follow-up or who had not died at the end of the study (52 weeks after the last participant was enrolled) were censored at the date of last contact.|From Study Day 1 until the data cut-off date of 2 January 2009; median follow-up time was 39 weeks, with a maximum of 93 weeks.|Primary Analysis Set||weeks||95% Confidence Interval|Median
732584|NCT00411450|Primary|Duration of Response|Duration of response is defined as the time from the date of first response to the date of first progression of disease during second-line treatment (as evaluated by the investigator) or death (if the death was due to disease progression but not detected earlier) in the subset of participants who responded (CR or PR, as evaluated by the investigator). Duration of response was analyzed using Kaplan-Meier methods; participants who responded but did not progress while on study were censored at the date of last tumor assessment.|Tumor response was assessed at Weeks 9, 17, 25, and 33, and once every 12 weeks thereafter until the end of second-line treatment; maximum time on treatment was 77 weeks.|Responders of Tumor Response Analysis Set||weeks||95% Confidence Interval|Median
732585|NCT00411450|Primary|Disease Control Rate at Weeks 17 and 25|The percentage of participants whose best response was either a complete or partial response or stable disease, based on modified RECIST criteria as assessed by the investigator. Stable diease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD of target lesions and no progression of existing non-target lesions and no new lesions, or, the persistence of 1 or more non-target lesions not qualifying for either CR or PD if no target lesions were identified at Baseline.|Week 17 and Week 25|Tumor Response Analysis Set||percentage of participants||95% Confidence Interval|Number
732595|NCT00411554|Secondary|Change From Baseline in 2 Hour Postprandial Glucose at Week 12|Change from baseline at Week 12 is defined as 2-hour postprandial glucose Week 12 minus 2-hour postprandial glucose Week 0.|Baseline and Week 12|The Per Protocol Population included patients with baseline and Week 12 (i.e., final primary timepoint) values for this outcome and excluded patients who met predefined criteria for protocol violations.||mg/dL||95% Confidence Interval|Least Squares Mean
732586|NCT00411450|Primary|Progression-free Survival Time|Progression-free survival time was defined as the time from Study Day 1 to the date of disease progression (based on investigator assessment) or the date of death due to any cause. Participants who terminated from the study early (eg, prior to disease progression due to fully withdrawn informed consent) were censored at their last tumor assessment.|From Study Day 1 until the data cut-off date of 2 January 2009; median follow-up time was 39 weeks, with a maximum of 93 weeks.|Primary Analysis Set||weeks||95% Confidence Interval|Median
732587|NCT00411450|Primary|Progression-free Survival Rate at Weeks 17 and 25|"The progression-free survival rate is defined as the Kaplan-Meier (KM) estimator of progression-free survival at Week 17 and Week 25 reported as the probability of being event (disease progression or death)-free. Tumor assessments were evaluated by the investigator according to modified RECIST criteria.
PD: At least a 20% increase in the size of target lesions since the treatment started or at least a 25% increase in the size of non-target lesions and the lesion(s) measure ≥ 10 mm, or the appearance of any new lesions. Participants who withdraw from the study prior to completion of Week 17 or 25 radiographic tumor assessments were censored at the last evaluable tumor assessment."|Week 17 and Week 25|Primary Analysis Set (all participants who provided informed consent prior to the initiation of any study specific procedures, received at least 1 dose of panitumumab, and who had valid KRAS mutation status data available)||percent probability||95% Confidence Interval|Number
732588|NCT00411450|Primary|Best Response During Second-Line Treatment|"Objective response rate is defined as the percentage of participants with a best response of complete response or partial response based on investigator review of scans using modified RECIST criteria. A complete or partial response was confirmed no less than 4 weeks after the criteria for response were first met. Participants with no post-baseline radiographic tumor assessment(s) were considered non-responders.
CR: disappearance of all target and non-target lesions and no new lesions. PR: At least a 30% decrease in the size of target lesions with no progression of non-target lesions (defined as a ≥ 25% increase in lesion size) and no new lesions, or, the disappearance of all target lesions but persistence of 1 or more non-target lesions not qualifying for either CR or PD and no new lesions."|Tumor response was assessed at Weeks 9, 17, 25, and 33, and once every 12 weeks thereafter until the end of second-line treatment; maximum time on treatment was 77 weeks.|Tumor Response Analysis Set||percentage of participants||95% Confidence Interval|Number
732589|NCT00411450|Secondary|Number of Participants With Adverse Events|The severity of adverse events (AEs) was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, except for panitumumab related skin toxicities, where Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE; Grade 5 = Death related to AE. The relationship of each adverse event to the panitumumab and/or FOLFIRI regimen was assessed by the investigator. A serious adverse event was defined as an adverse event that • is fatal • is life threatening • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • other significant medical hazard.|From the first dose date to 30 days after the last dose date. The median time frame is 4.5 months.|Safety analysis set (all participants who provided informed consent prior to the initiation of any study specific procedure and who received at least 1 dose of panitumumab)||participants|||Number
732590|NCT00411450|Primary|Objective Response Rate at Weeks 17 and 25|Objective response rate is defined as the percentage of participants with a best response of complete response or partial response. Disease assessments were based on investigator review of scans using modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria. A complete or partial response was confirmed no less than 4 weeks after the criteria for response were first met. Participants with no radiographic tumor assessment(s) at Week 17 or 25 were considered non-responders. Complete Response (CR): disappearance of all target and non-target lesions and no new lesions. Partial Response (PR): At least a 30% decrease in the size of target lesions with no progression of non-target lesions (defined as a ≥ 25% increase in lesion size) and no new lesions, or, the disappearance of all target lesions but persistence of 1 or more non-target lesions not qualifying for either CR or progressive disease (PD) and no new lesions.|Week 17 and Week 25|Tumor Response Analysis Set (all participants who provided informed consent prior to the initiation of any study specific procedures, received at least 1 dose of panitumumab, who had valid KRAS mutation status data available and with at least 1 uni-dimensionally measurable lesion per the local investigator)||percentage of participants||95% Confidence Interval|Number
732591|NCT00411463|Secondary|Number of Participants With a Response|Number of participants with response defined as an average of 50% (or greater) reduction in the subject’s baseline HRSD-25 score over three consecutive weeks and a current YMRS score ≤ 10|Week 12|||Participants|||Count of Participants
732592|NCT00411463|Secondary|Descriptive Measures of the Feasibility of IPSRT-BPII|Feasibility was assessed by ability to enroll, randomize, and retain participants in this trial. Completion of the study was used as evidence of feasibility.|Week 12|||Participants|||Count of Participants
732593|NCT00411463|Secondary|Quality of Life (QOL) Collected Using the Q-LES-Q (Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form)|The total score is derived by summing item scores 1 to 14. Higher scores are indicative of greater enjoyment or satisfaction in each domain. The Q-LES-Q-SF % maximum total score is calculated as 100% × (Q-LES-Q-SF total score - 14) / 56, and can range from 0% to 100%.|Baseline and Week 12|||scores on Q-LES-Q scale||95% Confidence Interval|Least Squares Mean
732594|NCT00411463|Primary|Number of Participants With Greater Than or Equal to 50% Reduction in Depression Scores, With a Mania Score Less Than or Equal to 10|Overall response rates (defined as greater than or equal to 50% reduction in depression scores without an increase in mania scores) were 29% (n=4) in the IPSRT group and 27% (n=3) in the quetiapine group. HRSD-25 scores are based on first 17 responses. Eight items are scored on a 5-pt scale, from 0 (not present) to 4 (severe.) Other nine items on the assessment are scored from 0-2. The higher the score on the HRSD-25, the worse the outcome is considered to be. A score of 0-7 is considered to be normal; 8-13 indicates mild depression, 14-18 indicates moderate depression, 19-22 indicates severe depression, and any score greater than or equal to 23 indicates very severe depression. The YMRS is an 11 point assessment. There are 4 items assessed on a scale ranging from 0 to 8 and the other 7 items are graded on a 0 to 4 scale. As with the HRSD, the higher the score on the YMRS indicates the presence of more or more severe manic symptoms and is associated with a worse outcome.|Week 12|||participants|||Number
734281|NCT00425269|Primary|The Fasting Plasma Glucose Value, Baseline||baseline|||mmol/L||95% Confidence Interval|Mean
732596|NCT00411554|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 12|Change from baseline at Week 12 is defined as fasting plasma glucose at Week 12 minus fasting plasma glucose at Week 0.|Baseline and Week 12|The Per Protocol Population included patients with baseline and Week 12 (i.e., final primary timepoint) values for this outcome and excluded patients who met predefined criteria for protocol violations.||mg/dL||95% Confidence Interval|Least Squares Mean
732597|NCT00411554|Primary|Change From Baseline in HbA1c at Week 12|HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the Week 0 HbA1c percent.|Baseline and Week 12|The Per Protocol Population included patients with baseline and Week 12 (i.e., final primary timepoint) values for this outcome and excluded patients who met predefined criteria for major protocol violations.||Percent||95% Confidence Interval|Least Squares Mean
732598|NCT00411619|Secondary|Overall Reduction in SEGA Tumor Volume.||During the entire study|||participants|||Number
732599|NCT00411619|Primary|Number With Observed Adverse Side Effects||During the entire study|||participants|||Number
732600|NCT00411645|Secondary|Plasma Concentration of Maribavir Metabolite VP 44469 During Treatment|Pharmacokinetic (PK) profile sampling was performed to evaluate plasma concentrations of VP 44469, a metabolite of Maribavir. During the study drug administration period, blood samples for this purpose were collected on Day 7 (Week 1) and at Week 4. Every effort was made to ensure that doses were administered 12 hours apart on the day before and on the day of PK sampling. Permissible assessment windows for PK profile sampling purposes were +/- 3 days and +/- 5 days for the 1- and 4- week samples, respectively. Samples were analyzed by a validated liquid chromatography tandem mass spectrometry (LC/MS/MS) method. The validated lower limit of quantitation (LLOQ) in plasma was 0.2 μg/mL.|12 hours post-dose after 1 and 4 weeks of treatment|The PK population, defined as those participants in the ITT population from whom plasma samples were drawn, tested for maribavir concentrations, and complete, evaluable PK data were available.||μg/mL||Standard Deviation|Mean
732601|NCT00411645|Secondary|Plasma Concentration of Maribavir During Treatment|Pharmacokinetic (PK) profile sampling was performed to evaluate plasma concentrations of Maribavir. During the study drug administration period, blood samples for this purpose were collected on Day 7 (Week 1) and at Week 4. Every effort was made to ensure that doses were administered 12 hours apart on the day before and on the day of PK sampling. Permissible assessment windows for PK profile sampling purposes were +/- 3 days and +/- 5 days for the 1- and 4- week samples, respectively. Samples were analyzed by a validated liquid chromatography tandem mass spectrometry (LC/MS/MS) method. The validated lower limit of quantitation (LLOQ) in plasma was 0.2 μg/mL.|12 hours post-dose after 1 and 4 weeks of treatment|The pharmacokinetic (PK) population, defined as those participants in the ITT population from whom plasma samples were drawn, tested for maribavir concentrations, and complete, evaluable PK data were available.||μg/mL||Standard Deviation|Mean
732602|NCT00411645|Secondary|Number of Participants Who Died Within 12 Months Post-Transplantation||Through 12 months post-transplant (Days 1 to 100, 6 months, and 12 months post-transplant)|The ITT-S population, defined as participants in the ITT population who received at least one dose of study drug.||participants|||Number
732603|NCT00411645|Secondary|Percent of Participants With Chronic Graft-Versus-Host Disease (GVHD)|Analysis of chronic GVHD was based on reported adverse events that mapped to the relevant MedDRA dictionary terms for chronic GVHD. The percentage reported is for the occurrence of any grade of chronic GVHD.|Through 6 months post-transplant (Days 1 to 100 and 6 months post-transplant)|The ITT-S population, defined as participants in the ITT population who received at least one dose of study drug.||percentage of participants|||Number
732604|NCT00411645|Secondary|Percent of Participants With Acute Graft-Versus-Host Disease (GVHD)|Analysis of acute GVHD was based on reported adverse events that mapped to the relevant MedDRA dictionary terms for acute GVHD. The percentage reported is for the occurrence of any grade of acute GVHD.|Through 6 months post-transplant (Days 1 to 100 and 6 months post-transplant)|The ITT Safety (ITT-S) population, defined as participants in the ITT population who received at least one dose of study drug.||percentage of participants|||Number
732605|NCT00411645|Secondary|Number of Participants With EC-confirmed CMV Disease Within 12 Months Post-Transplantation|All investigator-determined cases of CMV disease (i.e., CMV infection or CMV organ disease), were adjudicated by an independent, blinded EC. CMV infection was assessed by (1) pp65 antigenemia assay; (2) CMV DNA polymerase chain reaction (PCR); (3) either assay (pp65 antigenemia or CMV DNA PCR); or (4) initiation of anti-CMV therapy. CMV infection was defined as: CMV infection detected by a positive result from a CMV laboratory assay from at least one central laboratory assay (pp65 antigenemia or CMV DNA PCR assay in plasma) and fever >/=38 °C on >/=2 occasions >/=24 hours apart within a 7-day period and at least one of the following: new or increased malaise, two successive measurements of leucopenia (white blood cell [WBC] count <3500/mm3 or a WBC count decrease of 20% if the cell count prior to onset of clinical symptoms was >4000/mm3) >/=24 hours apart, atypical lymphocytosis >/=5%, and thrombocytopenia. CMV organ disease was defined as described by Ljungman et al., 2002.|12 months post-transplant|The ITT population, defined as all participants who were randomized to one of the therapy groups, regardless of whether the participant received study drug or had any post-baseline evaluations.||participants|||Number
732606|NCT00411645|Secondary|Number of Participants With CMV Infection or EC-confirmed CMV Disease Within 100 Days Post-Transplantation|All investigator-determined cases of CMV disease (i.e., CMV infection or CMV organ disease), were adjudicated by an independent, blinded EC. CMV infection was assessed by (1) pp65 antigenemia assay; (2) CMV DNA polymerase chain reaction (PCR); (3) either assay (pp65 antigenemia or CMV DNA PCR); or (4) initiation of anti-CMV therapy. CMV infection was defined as: CMV infection detected by a positive result from a CMV laboratory assay from at least one central laboratory assay (pp65 antigenemia or CMV DNA PCR assay in plasma) and fever >/=38 °C on >/=2 occasions >/=24 hours apart within a 7-day period and at least one of the following: new or increased malaise, two successive measurements of leucopenia (white blood cell [WBC] count <3500/mm3 or a WBC count decrease of 20% if the cell count prior to onset of clinical symptoms was >4000/mm3) >/=24 hours apart, atypical lymphocytosis >/=5%, and thrombocytopenia. CMV organ disease was defined as described by Ljungman et al., 2002.|100 days post-transplant|The ITT population, defined as all participants who were randomized to one of the therapy groups, regardless of whether the participant received study drug or had any post-baseline evaluations.||participants|||Number
732659|NCT00412113|Secondary|Subjects With BP <140/90 mmHg and LDL-C <130 mg/dL at Week 6.|Subjects achieving both JNC-7 blood pressure goal of <140/90 mmHg and NCEP/ATP III LDL-C goal <130 mg/dL at Week 6.|Week 6|Full analysis set (FAS).||participants|||Number
732607|NCT00411645|Secondary|Number of Participants With Investigator-determined CMV Disease|CMV infection was assessed by (1) pp65 antigenemia assay; (2) CMV DNA polymerase chain reaction (PCR); (3) either assay (pp65 antigenemia or CMV DNA PCR); or (4) initiation of anti-CMV therapy. CMV infection was defined as: CMV infection detected by a positive result from a CMV laboratory assay from at least one central laboratory assay (pp65 antigenemia or CMV DNA PCR assay in plasma) and fever >/=38 °C on >/=2 occasions >/=24 hours apart within a 7-day period and at least one of the following: new or increased malaise, two successive measurements of leucopenia (white blood cell [WBC] count <3500/mm3 or a WBC count decrease of 20% if the cell count prior to onset of clinical symptoms was >4000/mm3) >/=24 hours apart, atypical lymphocytosis >/=5%, and thrombocytopenia. CMV organ disease was defined as described by Ljungman et al., 2002.|Through 12 months post-transplant (Day 1 to 100 days, 6 months, and 12 months post-transplant)|The ITT population, defined as all participants who were randomized to one of the therapy groups, regardless of whether the participant received study drug or had any post-baseline evaluations.||participants|||Number
732608|NCT00411645|Secondary|Time to Onset of CMV Infection or EC-confirmed CMV Disease Within 6 Months Post- Transplantation|All investigator-determined cases of CMV disease (i.e., CMV infection or CMV organ disease) were adjudicated by an independent, blinded EC. CMV infection was assessed by (1) pp65 antigenemia assay or (2) CMV DNA polymerase chain reaction (PCR). CMV infection was defined as: CMV infection detected by a positive result from a CMV laboratory assay from at least one central laboratory assay (pp65 antigenemia or CMV DNA PCR assay in plasma) and fever >/=38 °C on >/=2 occasions >/=24 hours apart within a 7-day period and at least one of the following: new or increased malaise, two successive measurements of leucopenia (white blood cell [WBC] count <3500/mm3 or a WBC count decrease of 20% if the cell count prior to onset of clinical symptoms was >4000/mm3) >/=24 hours apart, atypical lymphocytosis >/=5%, and thrombocytopenia. CMV organ disease was defined as described by Ljungman et al., 2002.|6 months post-transplant|The ITT population, defined as all participants who were randomized to one of the therapy groups, regardless of whether the participant received study drug or had any post-baseline evaluations.||days||Inter-Quartile Range|Median
732609|NCT00411645|Secondary|Number of Participants With CMV Infection or EC-confirmed CMV Disease Within 6 Months Post-transplant|All investigator-determined cases of CMV disease (i.e., CMV infection or CMV organ disease), were adjudicated by an independent, blinded EC. CMV infection was assessed by (1) pp65 antigenemia assay; (2) CMV DNA polymerase chain reaction (PCR); (3) either assay (pp65 antigenemia or CMV DNA PCR); or (4) initiation of anti-CMV therapy. CMV infection was defined as: CMV infection detected by a positive result from a CMV laboratory assay from at least one central laboratory assay (pp65 antigenemia or CMV DNA PCR assay in plasma) and fever >/=38 °C on >/=2 occasions >/=24 hours apart within a 7-day period and at least one of the following: new or increased malaise, two successive measurements of leucopenia (white blood cell [WBC] count <3500/mm3 or a WBC count decrease of 20% if the cell count prior to onset of clinical symptoms was >4000/mm3) >/=24 hours apart, atypical lymphocytosis >/=5%, and thrombocytopenia. CMV organ disease was defined as described by Ljungman et al., 2002.|6 months post-transplant|The ITT population, defined as all participants who were randomized to one of the therapy groups, regardless of whether the participant received study drug or had any post-baseline evaluations.||participants|||Number
732610|NCT00411645|Primary|Number of Participants With Endpoint Committee (EC)-Confirmed Cytomegalovirus (CMV) Disease Within 6 Months Post-Transplantation|All investigator-determined cases of CMV disease (i.e., CMV infection or CMV organ disease), were adjudicated by an independent, blinded EC. CMV infection was assessed by (1) pp65 antigenemia assay; (2) CMV DNA polymerase chain reaction (PCR); (3) either assay (pp65 antigenemia or CMV DNA PCR); or (4) initiation of anti-CMV therapy. CMV infection was defined as: CMV infection detected by a positive result from a CMV laboratory assay from at least one central laboratory assay (pp65 antigenemia or CMV DNA PCR assay in plasma) and fever >/=38 °C on >/=2 occasions >/=24 hours apart within a 7-day period and at least one of the following: new or increased malaise, two successive measurements of leucopenia (white blood cell [WBC] count <3500/mm3 or a WBC count decrease of 20% if the cell count prior to onset of clinical symptoms was >4000/mm3) >/=24 hours apart, atypical lymphocytosis >/=5%, and thrombocytopenia. CMV organ disease was defined as described by Ljungman et al., 2002.|6 months post-transplant|The Intent-to-Treat (ITT) population, defined as all participants who were randomized to one of the therapy groups, regardless of whether the participant received study drug or had any post-baseline evaluations.||participants|||Number
732611|NCT00411671|Secondary|Tumor Response Measured Every 8-weeks|Tumor responses was measured according to RECIST criteria. Tumor responses were defined as: Partial Response (PR): at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD. Stable Disease (SD): steady state of disease. Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Progressive Disease (PD): at least a 20% increase in the sum of LD of measured lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|At baseline and then every 8 weeks until treatment discontinuation.|Of the enrolled participants, only 98 were evaluable for the outcome.||participants|||Number
732612|NCT00411671|Secondary|Progression-Free Survival|The Progression-Free Survival (PFS) was measured from date of randomization until progressive disease (PD) or death respectively.|From date of randomization until PD or death respectively, up to 3 years|Of the enrolled participants, only 98 were evaluable for the outcome.||months||Full Range|Median
732613|NCT00411671|Primary|8-Week Disease Control Rate|The disease control rate (DCR) was defined as the proportion of patients who did not meet Response Evaluation Criteria in Solid Tumors (RECIST) criteria for progressive disease (PD) at 8 weeks. Progressive disease was defined as at least a 20% increase in the sum of longest diameter (LD) of measured lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Baseline to 8 weeks|Of the enrolled participants, 98 were evaluable for the outcome.||percentage of participants|||Number
732614|NCT00411749|Secondary|HPV 6, 11, 16 and 18 Serum Antibody Titer at 24 Month After Completed Vaccination Series|Month 30 HPV cLIA Geometric Mean Titers by vaccine group.|24 month after completed vaccination series (Month 30)|The per protocol immunogenicity population includes all subjects who were not general protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 for the relevant HPV type, and a Month 30 serum sample collected within an acceptable time range.||Geometric Mean Titers (mMU/mL)||95% Confidence Interval|Geometric Mean
732615|NCT00411749|Primary|Human Papilloma Virus (HPV) 18 Serum Antibody Titer at One Month After Completed Vaccination Series|"Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers by vaccine group.
The limit of detection of the assay was 10 mMU/ml. GMTs and confidence limits below the limit of detection are shown as 10.0."|At one month after completed vaccination series (Month 7)|The per protocol immunogenicity population includes all subjects who were not general protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 for the relevant HPV type, and a Month 7 serum sample collected within an acceptable time range.||Geometric Mean Titers (mMU/mL)||95% Confidence Interval|Geometric Mean
732616|NCT00411749|Primary|Human Papilloma Virus (HPV) 16 Serum Antibody Titer at One Month After Completed Vaccination Series|"Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers by vaccine group.
The limit of detection of the assay was 11 mMU/ml. GMTs and confidence limits below the limit of detection are shown as 11.0."|At one month after completed vaccination series (Month 7)|The per protocol immunogenicity population includes all subjects who were not general protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 for the relevant HPV type, and a Month 7 serum sample collected within an acceptable time range.||Geometric Mean Titers (mMU/mL)||95% Confidence Interval|Geometric Mean
732617|NCT00411749|Primary|Human Papilloma Virus (HPV) 11 Serum Antibody Titer at One Month After Completed Vaccination Series|"Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers by vaccine group.
The limit of detection of the assay was 8 mMU/ml. GMTs and confidence limits below the limit of detection are shown as 8.0."|At one month after completed vaccination series (Month 7)|The per protocol immunogenicity population includes all subjects who were not general protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 for the relevant HPV type, and a Month 7 serum sample collected within an acceptable time range.||Geometric Mean Titers (mMU/mL)||95% Confidence Interval|Geometric Mean
732618|NCT00411749|Primary|Human Papilloma Virus (HPV) 6 Serum Antibody Titer at One Month After Completed Vaccination Series|"Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers (GMT) by vaccine group.
The limit of detection of the assay was 7 mMU/ml. GMTs and confidence limits below the limit of detection are shown as 7.0."|At one month after completed vaccination series (Month 7)|The per protocol immunogenicity population includes all subjects who were not general protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 for the relevant HPV type, and a Month 7 serum sample collected within an acceptable time range.||Geometric Mean Titers (mMU/mL)||95% Confidence Interval|Geometric Mean
732619|NCT00411762|Secondary|Median Overall Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Up to 100 weeks|20 subjects received 2 cycles or more and were evaluated for response||weeks||Full Range|Median
732620|NCT00411762|Primary|Median Progression Free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Up to 100 weeks|20 subjects received 2 cycles or more and were evaluated for response||weeks||Full Range|Median
732621|NCT00411788|Secondary|To Evaluate the Use of FDG-PET as an Early Predictor of Response to the Combination of Rapamycin and Trastuzumab, be Assessing Changes in Glucose Metabolism and Cell Viability Between Pre- and Post-treatment||Upon completion of study|This outcome measure was not collected nor analyzed due to study closure and low sample size.|||||
732622|NCT00411788|Secondary|To Determine if Currently Available RNA Expression Profiles Associated With Response to Herceptin Will be Predictably Altered in Tumors Treated With Trastuzumab and Rapamycin, and Will Further Elucidate the Mechanism of Synergy of These Two Agents||study completion|This outcome measure was not collected nor analyzed due to study closure and low sample size.|||||
732623|NCT00411788|Secondary|To Determine Pre and Post Therapy Changes in the Levels, Phosphorylation Status and/or Subcellular Localization of the Affected Signal Transduction Molecules HER2, Akt, S6K and 4EBP1 in Blood and Tumor Tissues|These data were not collected and analyzed as described here in the initial protocol submission.|Upon completion of study||||||
732624|NCT00411788|Secondary|Incidence of Cardiac Dysfunction|"This safety measure was used to determine the number of patients treated with the combination of trastuzumab and rapamycin with cardiac dysfunction.
This secondary outcome measure was reworded from its original version when results were entered."|study completion up to 58 weeks|Safety population consisting of 9 of 11 patients that received treatment following first dose.||participants|||Number
732625|NCT00411788|Secondary|Objective Response Rate (ORR)|"ORR was determined according to RECIST criteria, duration of response, and time to progression in patients with HER2 overexpressing advanced breast cancer receiving trastuzumab and rapamycin. The objective response rate (ORR) by response evaluation criteria (RECIST) 1.0, duration of response, safety, and pharmacodynamic endpoints.
This secondary outcome measure was reworded from its original submission when results were entered."|study completion up to 58 weeks|||participants|||Number
732626|NCT00411788|Primary|Proportion of Patients Who Are Progression-free (CR, PR and Stable Disease)|"To determine the clinical activity of oral daily rapamycin administered in combination with weekly intravenous trastuzumab in patients with HER2 overexpressing advanced breast cancer, the primary outcome is to determine the proportion of patients who are progression-free at 16 weeks, defined by complete response (CR), partial response (PR), or stable disease (SD).who are progression free at 16 weeks, defined by complete response (CR), partial response (PR), or stable disease (SD). Response objectives assessed using response evaluation criteria (RECIST) 1.0
This primary outcome was reworded from its original format when results were entered."|16 weeks|Nine patients were evaluable for response assessment. Two patients withdrew from study before first response assessment (one for noncompliance and the other for toxicity).||participants|||Number
732660|NCT00412113|Secondary|Subjects With BP <140/90 mmHg and LDL-C <130 mg/dL at Week 4.|Subjects achieving both JNC-7 blood pressure goal of <140/90 mmHg and NCEP/ATP III LDL-C goal <130 mg/dL at Week 4.|Week 4|Full analysis set (FAS). All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS.||participants|||Number
733344|NCT00410813|Secondary|Change in Serum Bone Turnover Markers Over Time -- BAP|Analysis included mean values of the serum biomarker BAP at baseline, 4, and 8 weeks.|at baseline, 4, and 8 weeks|Number of patients with samples to analyze: baseline n=66, 4 weeks n=54, 8 weeks n=52.||ug/L||Standard Deviation|Mean
732627|NCT00412061|Secondary|Progression Free Survival (PFS) as Per Adjudicated Central Review by Baseline Chromogranin A (CgA)|"Serum CgA levels in urine are frequently elevated in patients with advanced carcinoid tumors. Baseline levels of serum CgA were characterized relative to the upper limited of normal (ULN). CgA levels exceeding 2 x ULN were considered to be ‘Elevated’; otherwise considered as Non-elevated."|If elevated at baseline, evaluated every cycle visit (28 days/cycle) reported between day of first patient randomised, 10 January 2007, until cut-off date 02 April 2010|The Full Analysis Set (FAS; Intent-to-treat Population) consists of all randomized patients. This analysis includes PFS patients with non missing baseline CgA data.||Months||95% Confidence Interval|Median
732628|NCT00412061|Secondary|Number of Patients With Adverse Events (AEs), Clinically Notable AE, Death, Serious Adverse Events (SAEs) (Open Label Phase)|AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. SAEs are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.|From first day of treatment up to 28 days after last day of treatment in double blind|The Safety Set consists of all patients who received at least one dose of study drug and who had at least one valid post-baseline safety assessment.||Patients|||Number
732629|NCT00412061|Secondary|Number of Patients With Adverse Events (AEs), Clinically Notable AE, Death, Serious Adverse Events (SAEs) (Double-Blind Phase)|AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. SAEs are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.|From first day of treatment up to 28 days after last day of treatment in double blind|The Safety Set consists of all patients who received at least one dose of study drug and who had at least one valid post-baseline safety assessment.||Patients|||Number
732630|NCT00412061|Secondary|Overall Survival Using Kaplan-Meier Methodology|Overall survival was defined as the time from the date of randomization to the date of death from any cause. If a patient was not known to have died, survival was censored at the date of last contact. Kaplan-Meier methodology was used to estimate the median overall survival for each treatment group.|Months 12, 24, 36, 48|The Full Analysis Set (FAS; Intent-to-treat Population) consists of all randomized patients.||Percentage of Participants||95% Confidence Interval|Number
732631|NCT00412061|Secondary|Progression Free Survival (PFS) as Per Adjudicated Central Review by Baseline 5-hydroxyindoleacetic Acid (5-HIAA) Level|5-HIAA levels in urine are frequently elevated in patients with advanced carcinoid tumors. Baseline levels of 5-HIAA in urine were defined as ‘High’ if they exceeded the median value, and ‘Low’ if they were lower than or equal to the median.|If elevated at baseline, evaluated every cycle visit (28 days/cycle) reported between day of first patient randomised, 10 January 2007, until cut-off date 02 April 2010|The Full Analysis Set (FAS; Intent-to-treat Population) consists of all randomized patients. This analysis includes PFS patients with non missing baseline 5-HIAA data.||Months||95% Confidence Interval|Median
732632|NCT00412061|Secondary|Best Overall Response Rate as Per Adjudicated Central Radiology Review Based on Response Evaluation Criteria in Solid Tumors (RECIST)|The best overall response rate is defined as the percentage of patients having achieved confirmed Complete Response + Partial Response. Complete Response (CR) = at least two determinations of CR at least 4 weeks apart before progression. • Partial response (PR) = at least two determinations of PR or better at least 4 weeks apart before progression.|Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 10 January 2007, until cut-off date 02 April 2010|The Full Analysis Set (FAS; Intent-to-treat Population) consists of all randomized patients.||Percentage of patients||95% Confidence Interval|Number
732633|NCT00412061|Primary|Progression Free Survival (PFS) as Per Adjudicated Central Radiology Review|Progression free survival (PFS) is defined as the time from randomization to the date of first documented disease progression or death from any cause. The primary analysis of PFS was based on the independent central adjudicated assessment using Kaplan-Meier method.|Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 10 January 2007, until cut-off date 02 April 2010|The Full Analysis Set (FAS) consisted of all randomized patients.||Months||95% Confidence Interval|Median
732634|NCT00412074|Secondary|Infant Health Status - Vitamin D Deficiency|Percentage of infants with 25-hydroxyvitamin D [25(OH)D] concentration <20 ng/mL at Visit 7|to 7 months of age|The number of infants analyzed in each group was fewer than the number of subjects analyzed for the maternal outcomes - though blood draws were attempted for all infants at Visit 7, we were unable to obtain blood from 14 infants in the 400 IU arm, 7 infants in the 2400 IU arm, and 14 infants in the 6400 IU arm.||percentage|||Number
732635|NCT00412074|Secondary|Maternal Health Status - Vitamin D Deficiency|Percentage of subjects with 25-hydroxyvitamin D [25(OH)D] concentration <20 ng/mL at Visit 7|to 7 months postpartum|||percentage|||Number
732636|NCT00412074|Primary|25-Hydroxyvitamin D Levels for Postpartum Mother 7 Months After Delivery||to 7 months postpartum|||ng/mL||Standard Deviation|Mean
732637|NCT00412087|Secondary|Parathyroid Hormone at Visit 7|Intact parathyroid hormone at Visit 7, one month prior to delivery|7 months|There was 1 subject in the 2000 IU group and 3 subjects in the 4000 IU group missing PTH measurements.||pg/mL||Standard Deviation|Mean
732638|NCT00412087|Primary|25-hydroxyvitamin D at Visit 7|25-hydroxyvitamin D at Visit 7, one month prior to delivery|7 months|||ng/mL||Standard Deviation|Mean
732661|NCT00412113|Secondary|Subjects With Blood Pressure of <140/90 mmHg and LDL-C <100 mg/dL at Week 4|Subjects achieving both the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC)-7 blood pressure goal of <140/90 mmHg and the National Cholesterol Education Program Adult Treatment Panel (NCEP/ATP) III Update low density lipoprotein-cholesterol (LDL-C) goal <100 mg/dL at Week 4.|Week 4|Full analysis set. All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS.||participants|||Number
732639|NCT00412113|Primary|Change From Baseline to Week 6 in Framingham Predicted Absolute 10-year Risk|Framingham prediction of absolute 10-year risk of Coronary Heart Disease (CHD) outcomes (myocardial infarction [MI] or CHD death) are calculations based on total point score (range less than negative 3 [best] to greater than or equal to 14 [worst] for men; less than or equal to negative 2 [best] and greater than or equal to 17 [worst] for women) of subject age, sex, current blood pressure treatment status, current smoking status, total cholesterol, high-density lipoprotein cholesterol, and systolic blood pressure calculated at Week 6. Mean at observation minus mean at baseline.|Week 6, baseline|The full analysis set of all randomized subjects who took at least one dose of study drug and had any post-baseline efficacy assessment||score on scale||Standard Deviation|Least Squares Mean
732640|NCT00412113|Secondary|Change From Baseline to Week 4 in Framingham Predicted Absolute 10-year Risk.|Framingham prediction of absolute 10-year risk of CHD outcomes (MI or CHD death) are calculations based on total point score (range less than negative 3 [best] to greater than or equal to 14 [worst] for men; less than or equal to negative 2 [best] and greater than or equal to 17 [worst] for women) of subject age, sex, current blood pressure treatment status, current smoking status, total cholesterol, high-density lipoprotein cholesterol and systolic blood pressure calculated at Week 4. Mean at observation minus mean at baseline.|Week 4, baseline|Full analysis set (FAS). All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS.||score on scale||Standard Deviation|Least Squares Mean
732641|NCT00412113|Secondary|Change From Baseline in Triglycerides (TG) at Week 6.|Mean change at observation minus mean baseline.|Week 6 , baseline|Full analysis set (FAS). All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS.||mg/dL||Standard Deviation|Mean
732642|NCT00412113|Secondary|Change From Baseline in Total Cholesterol (TC) to Week 6.|Mean change at observation minus baseline.|Week 6, baseline|Full analysis set (FAS) All randomized subjects who take at least one dose of study drug and have any post-baseline efficacy assessments.||mg/dL||Standard Deviation|Mean
732643|NCT00412113|Secondary|Change From Baseline in HDL at Week 6.|Mean change at observation minus baseline.|Week 6, baseline|Full analysis set (FAS). All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS.||mg/dL||Standard Deviation|Mean
732644|NCT00412113|Secondary|Change From Baseline in LDL at Week 6.|Mean change at observation minus baseline.|Week 6, baseline|Full analysis set. All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS.||mg/dL||Standard Deviation|Mean
732645|NCT00412113|Secondary|Change From Baseline in Triglycerides (TG) to Week 4.|Mean change at observation minus baseline|Week 4, baseline|Full analysis set (FAS). All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS.||mg/dL||Standard Deviation|Mean
732646|NCT00412113|Secondary|Change in Total Cholesterol (TC) From Baseline to Week 4.|Mean change at observation minus baseline.|Week 4, baseline|Full analysis set (FAS). All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS.||mg/dL||Standard Deviation|Mean
732647|NCT00412113|Secondary|Change From Baseline in High Density Lipoprotein (HDL) at Week 4.|Mean change at observation minus baseline.|Week 4, baseline|Full analysis set (FAS) All randomized subjects who take at least one dose of study drug and have any post-baseline efficacy assessments.||mg/dL||Standard Deviation|Mean
732648|NCT00412113|Secondary|Change From Baseline in LDL at Week 4.|Change: mean of observation minus mean at baseline.|Week 4, baseline|Full analysis set (FAS) All randomized subjects who take at least one dose of study drug and have any post-baseline efficacy assessments.||mg/dL||Standard Deviation|Mean
732649|NCT00412113|Secondary|Change From Baseline to Week 6 in Pulse Rate|Mean at observation minus mean at baseline|Week 6, baseline|Full analysis set (FAS). All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS.||bpm||Standard Deviation|Mean
732650|NCT00412113|Secondary|Change From Baseline to Week 6 in Diastolic Blood Pressue (DBP)|Change from mean at observation minus mean at baseline|Week 6, baseline|Full analysis set (FAS). All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS.||mmHg||Standard Deviation|Median
732651|NCT00412113|Secondary|Change From Baseline to Week 6 in Systolic Blood Pressure (SBP)|Mean change at observation minus mean baseline.|Week 6, baseline|Full analysis set: all randomized subjects who take at least one dose of study drug and have any post-baseline efficacy assessments.||mmHg||Standard Deviation|Mean
732652|NCT00412113|Secondary|Change From Baseline to Week 4 in Pulse Rate|Mean at observation minus mean at baseline measured in beats per minute (bpm).|Week 4, baseline|Full analysis set (FAS). All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS.||bpm||Standard Deviation|Mean
732653|NCT00412113|Secondary|Change From Baseline to Week 4 in Diastolic Blood Pressure (DBP)|Mean at observation minus mean at baseline|Week 4, baseline|Full analysis set (FAS). All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS.||mmHg||Standard Deviation|Mean
732654|NCT00412113|Secondary|Change From Baseline to Week 4 in Systolic Blood Pressure (SBP).|Mean at observation minus mean at baseline|Week 4, baseline|Full analysis set (FAS). All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS.||mmHg||Standard Deviation|Mean
732655|NCT00412113|Secondary|Subjects With BP < 140/90 mmHg at Week 6|Subjects achieving BP goal of <140/90 mmHg at week 6|Week 6|Full analysis set (FAS) All randomized subjects who take at least one dose of study drug and have any post-baseline efficacy assessments.||participants|||Number
732656|NCT00412113|Secondary|Subjects With BP < 140/90 mmHg at Week 4|Subjects achieving BP goal of <140/90 mmHg at week 4|Week 4|Full analysis set (FAS). All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS||participants|||Number
732657|NCT00412113|Secondary|Subjects With LDL-C < 100 mg/dL at Week 6|Subjects Who achieve a goal of LDL-C < 100 mg/dL at Week 6.|Week 6|Full analysis set (FAS) All randomized subjects who take at least one dose of study drug and have any post-baseline efficacy assessments.||participants|||Number
732658|NCT00412113|Secondary|Subjects With LDL-C < 100 mg/dL at Week 4|Subjects Who achieve a goal of LDL-C < 100 mg/dL at Week 4.|Week 4|Full analysis set (FAS). All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS.||participants|||Number
732662|NCT00412113|Primary|Subjects With Blood Pressure (BP) <140/90 Millimeters of Mercury (mmHg) and Low Density Lipoprotein Cholesterol (LDL-C) <100 Milligrams Per Deciliter(mg/dL) at Week 6|Number of subjects reaching dual goal of systolic blood pressure <140 millimeters of mercury (mmHg) and diastolic blood pressue of <90 mmHg and low density lipoprotein-cholesterol(LDL-C) <100 milligrams per deciliter(mg/dL)|Week 6|Full analysis set (FAS) is all randomized subjects who take at least one dose of study drug and and have any post-baseline efficacy assessments.||participants|||Number
732663|NCT00412217|Secondary|Overall Survival (OS)|OS was defined as the time from inclusion in the study to date of death for any reason. The median duration of OS and corresponding 95% CI were to be estimated by Kaplan-Meier analysis and expressed in months.|From inclusion in the study until death from any cause (maximum up to 3 years overall)|ITT Population.||months||95% Confidence Interval|Median
732664|NCT00412217|Secondary|Number of Participants Who Died|The number of participants who died from any cause was reported.|From inclusion in the study until death from any cause (maximum up to 3 years overall)|ITT Population.||participants|||Number
732665|NCT00412217|Primary|Time to Progression (TTP)|Tumor response was assessed by the Investigator according to standard-of-care criteria, as there were no protocol-specified criteria for the assessment of tumor response and the instrument for assessment was deferred to the Investigator. TTP was defined as the time from inclusion in the study to the time of disease progression, appearance of second tumor, or death from any cause, whichever occurred first. To ensure comparability, baseline radiological studies later used to verify progression must be performed using identical techniques. The median duration of TTP and corresponding 95% confidence interval (CI) were to be estimated by Kaplan-Meier analysis and expressed in months.|From inclusion in the study until disease progression, appearance of second tumor, or death from any cause (maximum up to 3 years overall)|ITT Population.||months||95% Confidence Interval|Median
732666|NCT00412217|Primary|Number of Participants With Disease Progression|Tumor response was assessed by the Investigator according to standard-of-care criteria, as there were no protocol-specified criteria for the assessment of tumor response and the instrument for assessment was deferred to the Investigator. To ensure comparability, baseline radiological studies later used to verify progression must be performed using identical techniques. The number of participants who experienced disease progression was reported.|From inclusion in the study until disease progression (maximum up to 3 years overall)|ITT Population.||participants|||Number
732667|NCT00412243|Primary|Maximum Tolerated Dose for Cyclophosphamide (MTD)|MTD is dose at which there are no dose limiting toxicity (DLT) defined as any =/> grade 3 drug-related non-hematologic toxicity that occurs within the first 14 days after start of treatment. Evaluation using continual reassessment method; 3-5 Day Cycle|First 14 days of each cycle|MTD calculated with first 8 study participants.||mg/m^2|||Number
732668|NCT00412360|Secondary|Immune Reconstitution||100 days, 6 months, 1 and 2 years||||||
732669|NCT00412360|Secondary|Chimerism||28, 42, 60, 180, 365 days||||||
732670|NCT00412360|Secondary|Engraftment Syndrome||Day 100|||participants|||Number
732671|NCT00412360|Secondary|Platelet Engraftment|Platelet engraftment to 50,000/mL|Day 180|||percentage of participants||95% Confidence Interval|Number
732672|NCT00412360|Secondary|Relapse|Testing for recurrent malignancy in the blood, marrow or other sites will be used to assess relapse after transplantation. For the purpose of this study, relapse is defined by either morphological or cytogenetic evidence of AML, ALL, CML, or MDS consistent with pre-transplant features.|Year 1|||percentage of participants||95% Confidence Interval|Number
732673|NCT00412360|Secondary|Infections||Year 2|||participants|Participants||Number
732674|NCT00412360|Secondary|Treatment-related Mortality||Year 1|||percentage of participants||95% Confidence Interval|Number
732675|NCT00412360|Secondary|Chronic GVHD|Incidences of chronic GVHD will be scored according to the BMT CTN MOP.|Year 1|||percentage of participants||95% Confidence Interval|Number
732676|NCT00412360|Secondary|Acute Graft-versus-host Disease (GVHD)|Incidences of grade II – IV and III – IV acute GVHD at Day 100 will be graded according to the BMT CTN Manual of Procedures (MOP).|Day 100|||participants|||Number
732677|NCT00412360|Secondary|Neutrophil Engraftment|Neutrophil engraftment is defined as achieving an ANC ≥ 500/mm3 for three consecutive measurements on different days. The first of the three days will be designated the day of neutrophil engraftment.|Day 180|||percentage of participants||95% Confidence Interval|Number
732678|NCT00412360|Secondary|Disease-free Survival|Disease-free survival is defined as the minimum time interval of the times to relapse/recurrence, to death or to last follow-up.|Year 1|||percentage of participants||95% Confidence Interval|Number
732679|NCT00412360|Primary|Overall Survival||Year 1|||percentage of participants||95% Confidence Interval|Number
732680|NCT00412373|Other Pre-specified|Young Mania Rating Scale (YMRS) With Baseline YMRS Total Score >= 16 - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.|11-item scale (elevated mood, increased motor activity, sexual interest, sleep, irritability, speech [rate/amount], language-thought disorder, content, disruptive-aggressive behaviors, appearance, and insight) based on subject's report of his or her condition and clinician's behavioral observations during the interview, with emphasis on the latter. Higher scores indicate worsening. The responses are summed to yield the YMRS total score, which ranges from 0 to 60.|Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment|Intent-to-Treat||points on a scale||Standard Deviation|Mean
732681|NCT00412373|Other Pre-specified|Baseline Young Mania Rating Scale (YMRS) With Baseline YMRS Total Score >= 16|11-item scale (elevated mood, increased motor activity, sexual interest, sleep, irritability, speech [rate/amount], language-thought disorder, content, disruptive-aggressive behaviors, appearance, and insight) based on subject's report of his or her condition and clinician's behavioral observations during the interview, with emphasis on the latter. Higher scores indicate worsening. The responses are summed to yield the YMRS total score, which ranges from 0 to 60.|Baseline|Intent-to-Treat||points on a scale||Standard Deviation|Mean
732707|NCT00412516|Secondary|Measles Seropositivity at 12 Months|Seropositivity defined as an anti-MV IgG concentration of 120 mIU/mL determined with the Siemens ELISA|12 months post vaccination|||percentage of subjects seropositive||95% Confidence Interval|Number
732708|NCT00412516|Primary|Measles Seropositivity at 24 and 36 Months|Seropositivity defined as an anti-MV IgG concentration of 120 mIU/mL determined with the Siemens ELISA|24, 36 months post vaccination|||percentage of participants seropositive||95% Confidence Interval|Number
732682|NCT00412373|Other Pre-specified|Hamilton Rating Scale for Depression (HAM-D-21) With Baseline HAM-D-21 Total Score >= 16 - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.|Clinician-rated scale that evaluates depressed mood as well as the vegetative and cognitive symptoms of depression. The items are rated on either a 5-point (0 to 4) or a 3-point (0 to 2) scale. The 5-point scale uses a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). Higher scores indicate worsening. The responses are summed to yield the HAM-D-21 score that ranges from 0-63.|Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment|Intent-to-Treat||points on a scale||Standard Deviation|Mean
732683|NCT00412373|Other Pre-specified|Baseline Hamilton Rating Scale for Depression (HAM-D-21) With Baseline HAM-D-21 Total Score >= 16|Clinician-rated scale that evaluates depressed mood as well as the vegetative and cognitive symptoms of depression. The items are rated on either a 5-point (0 to 4) or a 3-point (0 to 2) scale. The 5-point scale uses a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). Higher scores indicate worsening. The responses are summed to yield the HAM-D-21 score that ranges from 0-63.|Baseline|Intent-to-Treat||points on a scale||Standard Deviation|Mean
732684|NCT00412373|Secondary|Participants With Response|Response is defined as a 30% or more reduction from baseline PANSS total score and CGI-C score of <= 2 (CGI-C-SCA: Clinical Global Impression of Change for Schizoaffective Disorder).|Week 6 LOCF End Point|Intent-to-Treat||participants|||Number
732685|NCT00412373|Secondary|Clinical Global Impression (CGI-C) - Change for Schizoaffective Disorder|"The CGI-C rating scale is a 7 point global assessment that measures the clinician's impression of the change occurring in the illness over a course of treatment, relative to baseline. A rating of 4 is equivalent to No change. Ratings of <4 are equivalent to improvement and ratings of > 4 are equivalent to worsening. Higher scores indicate worsening."|Week 6 or the last post-randomization assessment during double-blind treatment|Intent-to-Treat||points on a scale||Standard Deviation|Mean
732686|NCT00412373|Secondary|Clinical Global Impression (CGI-S) - Severity for Schizoaffective Disorder - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a subject. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill subjects. Higher scores indicate worsening."|Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment|Intent-to-Treat||points on a scale||Standard Deviation|Mean
732687|NCT00412373|Secondary|Clinical Global Impression (CGI-S) - Severity for Schizoaffective Disorder Score at Baseline|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a subject. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill subjects. Higher scores indicate worsening."|Baseline|Intent-to-Treat||points on a scale||Standard Deviation|Mean
732688|NCT00412373|Secondary|Positive and Negative Symptoms of Schizophrenia (PANSS) Anxiety/Depression Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.|Anxiety/Depression PANSS Factor Score (range 4-28): Sum of scores for items 2, 3, 4, and 6 in general psychopathology subscale: Anxiety, Guilt feelings, Tension, Depression. Higher scores indicate worsening.|Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment|Intent-to-Treat||points on a scale||Standard Deviation|Mean
732689|NCT00412373|Secondary|Positive and Negative Symptoms of Schizophrenia (PANSS) Uncontrolled Hostility/Excitement Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.|Uncontrolled Hostility/Excitement PANSS Factor Score (range 4-28): Sum of scores for items 4 and 7 in positive subscale: excitement, hostility; and items 8 and 14 in general psychopathology subscale: uncooperativeness, and poor impulse control. Higher scores indicate worsening.|Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment|Intent-to-Treat||points on a scale||Standard Deviation|Mean
732690|NCT00412373|Secondary|Positive and Negative Symptoms of Schizophrenia (PANSS) Disorganized Thought Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.|Disorganized Thoughts PANSS Factor Score (range 7-49): Sum of scores for item 2 in positive subscale:Conceptual disorganization; item 5 in negative subscale:difficulty in abstract thinking; and items 5, 10, 11, 13, and 15 in general psychopathology subscale: mannerisms/posturing, disorientation, poor attention, disturbance of volition, and preoccupation. Higher scores indicate worsening.|Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment|Intent-to-Treat||points on a scale||Standard Deviation|Mean
732691|NCT00412373|Secondary|Positive and Negative Symptoms of Schizophrenia (PANSS) Negative Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.|Negative PANSS Factor Score (range 7-49): Sum of scores for items 1, 2, 3, 4, and 6 in negative subscale: blunted affect, emotional withdrawal, poor rapport, passive social withdrawal, lack of spontaneity; and items 7 and 16 in general psychopathology subscale: motor retardation, and active social avoidance. Higher scores indicate worsening.|Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment|Intent-to-Treat||points on a scale||Standard Deviation|Mean
732692|NCT00412373|Secondary|Positive and Negative Symptoms of Schizophrenia (PANSS) Positive Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.|Positive PANSS Factor Score (range 8-56): Sum of scores for items 1, 3, 5, and 6 in positive subscale: delusions, hallucinatory behavior, grandiosity, suspiciousness; item 7 in negative subscale: stereotyped thinking; and items 1, 9, and 12 in general psychopathology subscale: somatic concern, unusual thought content, lack of judgment, and insight. Higher scores indicate worsening.|Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment|Intent-to-Treat||points on a scale||Standard Deviation|Mean
732693|NCT00412373|Secondary|Positive and Negative Symptoms of Schizophrenia (PANSS) General Psychopathology Subscale Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.|General Psychopathology (range 16-112): Sum of scores for somatic concern, anxiety, guilt feelings, tension, mannerisms/posturing, depression, motor retardation, uncooperativeness, unusual thought content, disoriented, poor attention, lack of judgment/insight, disturbance of volition, poor impulse control, preoccupation, and active social avoidance. Higher scores indicate worsening.|Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment|Intent-to-Treat||points on a scale||Standard Deviation|Mean
732694|NCT00412373|Secondary|Positive and Negative Symptoms of Schizophrenia (PANSS) Negative Subscale Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.|Negative Syndrome Scale (range 7-49): Sum of scores for items 1-7 in negative subscale: blunted effect, emotional withdrawal, poor rapport, passive apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Higher scores indicate worsening.|Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment|Intent-to-Treat||points on a scale||Standard Deviation|Mean
732695|NCT00412373|Secondary|Positive and Negative Symptoms of Schizophrenia (PANSS) Positive Subscale Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.|Positive Syndrome Scale (range 7-49): Sum of scores for items 1-7 in positive subscale: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. Higher scores indicate worsening.|Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment|Intent-to-Treat||points on a scale||Standard Deviation|Mean
732696|NCT00412373|Primary|Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.|The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.|The primary efficacy endpoint was the change from baseline to week 6 or the last post-randomization assessment during double-blind treatment in the PANSS total score.|The Intent-to-Treat population included all randomly assigned subjects who received at least 1 dose of study medication (or any portion of a dose) and had both baseline and at least 1 postbaseline PANSS assessment.||points on a scale||Standard Deviation|Mean
732697|NCT00412373|Primary|Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score at Baseline.|The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.|Baseline|The Intent-to-Treat population included all randomly assigned subjects who received at least 1 dose of study medication (or any portion of a dose) and had both baseline and at least 1 postbaseline PANSS assessment.||points on a scale||Standard Deviation|Mean
732698|NCT00412425|Primary|Cumulative Participants Response to Palonosetron|Participants response measured as incidences biochemotherapy emesis and those of nausea interfering with appetite, sleep, physical activity, social life and enjoyment of life are summarized. Response evaluated during 5-day administration of biochemotherapy and the 23 subsequent days after therapy ends.|7 days|Analysis was per protocol.||episodes of nausea/vomiting|||Number
732699|NCT00412451|Primary|PVD Induction|The primary efficacy variable was the proportion of patients with total posterior vitreous detachment (PVD) on Day 14 as determined by a masked central reading center (CRC) using 4-quadrant B-scan and optical coherence tomography (OCT)|Day 14 post-injection|Intent-To-Treat (ITT), Last Observation Carried Forward (LOCF)||percentage of participants|||Number
732700|NCT00412464|Primary|Thrombocytopenic Events|Patient’s platelet counts should be kept above 50 x 10^9/L while on study with platelet transfusions as needed with the exception of patients enrolled under the HIT/ suspicion of HIT inclusion (platelet transfusions are contraindicated in HIT). With regards to study patients who experience progressive decreases in platelet count to below 50 x 10^9/L while receiving fondaparinux (excluding patients being treated for HIT or suspicion of HIT), fondaparinux will be discontinued.|Study period which was up to 21 days of fondaparinux|||Adverse Events|||Number
732701|NCT00412464|Primary|Adverse Events|Adverse events will be defined as any untoward or unexpected event which can be a symptom, physical exam sign or laboratory abnormality. Adverse events will be classified as serious if they lead to prolonged hospitalization, re-hospitalization, transfer to an intensive care unit, or death. Adverse events will be categorized in terms of their likely association with fondaparinux as probably related, possibly related, unrelated, or unknown, and will be recorded according to standard adverse reporting guidelines for clinical trials.|Study period which was up to 21 days of fondaparinux|||Adverse Events|||Number
732702|NCT00412464|Primary|Bleeding Events|Bleeding assessment Patients will be monitored for bleeding symptoms by physician and nursing assessment. Major bleeding will be defined as bleeding which is in a critical space (intracranial, retroperitoneal, or visceral) or leads to the need for blood transfusion. Minor bleeding will be all other bleeding and will be classified as clinically significant (i.e. If the physician has to take action to treat the minor bleed) or clinically insignificant (i.e. if the physician does not need to intervene to treat the minor bleed).|Study period which was up to 21 days of fondaparinux|||Adverse Events|||Number
732703|NCT00412464|Primary|Therapeutic Plasma Concentration of Fondaparinux at 21 Days|Subjects all had detailed pharmacokinetic measurements done which were subsequently analyzed in a population pharmacokinetic model. This model then informed the dosing recommendations that were published as a result of the study.|21 days|||mg/dL||Standard Deviation|Mean
732704|NCT00412464|Primary|Number of Abnormal Lab Results Resulting in Adverse Events.|The primary outcome measure was assessment of safety by reporting the number of abnormal lab results resulting in adverse events. Safety laboratory assessments are as follows: Liver and kidney toxicity will be determined by serial measurements of AST, ALT, total bilirubin, BUN and creatinine. Hematologic toxicity will be assessed by serial CBCs.|Study period which was up to 21 days of fondaparinux|||Adverse Events|||Number
732705|NCT00412516|Secondary|Geometric Mean Neutralizing Antibody Titer to Japanese Encephalitis (JE) Virus in Infants in the Philippines Who Received Measles Vaccine (MV) Before, With, or After SA 14-14-2 JE Vaccination by Month After JE Vaccination.|Neutralizing antibody titer determined using a 50% plaque-reduction neutralizing assay (PRNT-50) for JE virus|12, 24, 36 months post-JE vaccination|||GMT||95% Confidence Interval|Mean
732706|NCT00412516|Secondary|Seropositive Rate for Japanese Encephalitis (JE) Antibody in Infants in the Philippines Who Received Measles Vaccine (MV) Before, With, or After SA 14-14-2 JE Vaccination by Month After JE Vaccination.|“Seropositive” defined as a person with neutralizing antibody against JE virus at a titer ≥ 1:10 in a 50% plaque-reduction neutralizing assay (PRNT-50)|12 months, 24 months, and 36 months post vaccination|||percentage of subjects seropositive||95% Confidence Interval|Number
732709|NCT00412529|Secondary|Number of Patients Who Are Polymerase Chain Reaction (PCR) Negative|PCR negative was considered <300 copies/mL. PCR positive was considered =>300 copies/mL.|At Week 12|Intent to Treat (ITT) population included all patients who received at least one dose of study drug and had at least one post-baseline assessment of serum HBV DNA. The randomized treatment was used in the analyses of this population.||Participants|||Number
732710|NCT00412529|Secondary|Characterization of Very Early Viral Kinetics: Estimation of the Efficiency Factor of Blocking Virus Production|Viral kinetic parameters were estimated with a bi-phasic mathematical model of HBV DNA by using compartments of free virus, infected cells, and uninfected target cells. The model parameter of interest was the effectiveness of the drug in blocking virus production from infected cells (efficacy, ε). Blocking efficiency was within the range between 0 and 1.|Baseline to 12 weeks|Intent to Treat (ITT) population.||percentage of blocking efficiency||Standard Deviation|Mean
732711|NCT00412529|Secondary|Characterization of Very Early Viral Kinetics: Estimation of the Rate of Infected Cell Loss|"Viral kinetic parameters were estimated with a bi-phasic mathematical model:
V(t) = (1-ε)pI(t) – cV(t)
I(t) = (1- η)TV(t) – δI(t)
V serum viral load, I productively infected cells, ε efficiency factor of blocking virus production, p viral production rate, c viral clearance rate, η efficiency factor of blocking de novo infection, β de novo infection rate, T uninfected target cells, δ rate of infected cell loss. Maximum-likelihood estimation for the viral kinetic parameters entailed fitting a nonlinear differential equation system via the least-squares approach from serum HBV DNA data."|Baseline to 12 weeks|Intent to Treat (ITT) population. The value for the rate of infected cell loss for 1 patient in telbivudine arm was not used in calculation of summary statistics for this variable as this patient showed a deviation from the biphasic pattern in viral kinetic modeling.||infected cell loss per day||Standard Deviation|Mean
732712|NCT00412529|Secondary|Characterization of Very Early Viral Kinetics: Estimation of Viral Clearance|"Viral kinetic parameters were estimated with a bi-phasic mathematical model:
V(t) = (1-ε)pI(t) – cV(t)
I(t) = (1- η)TV(t) – δI(t)
V serum viral load, I productively infected cells, ε efficiency factor of blocking virus production, p viral production rate, c viral clearance rate, η efficiency factor of blocking de novo infection, β de novo infection rate, T uninfected target cells, δ rate of infected cell loss. Maximum-likelihood estimation for the viral kinetic parameters entailed fitting a nonlinear differential equation system via the least-squares approach from serum HBV DNA data."|Baseline to 12 weeks|Intent to Treat (ITT) population.||clearance per day||Standard Deviation|Mean
732713|NCT00412529|Secondary|Change in Alanine Aminotransferase (ALT) Levels||From Baseline to Week 12|Intention to treat (ITT) population included all patients who received at least one dose of study drug and had at least one post-baseline assessment of serum HBV DNA. The randomized treatment was used in the analyses of this population.||IU/L||Standard Deviation|Mean
732714|NCT00412529|Secondary|The Area Under the Curve (AUC) of HBV DNA Change.|In AUC efficacy analyses, all the visits from baseline to Week 12 visit (including the planned and the repeated) with a non-missing HBV DNA level were included.|From Baseline to Week 12|Intention-to-treat (ITT) population included all patients who received at least one dose of study drug and had at least one post-baseline assessment of serum HBV DNA. The randomized treatment was used in the analyses of this population.||(log10 copies/mL) * days||Standard Deviation|Mean
732715|NCT00412529|Secondary|Change in Mean HBV DNA Level|Baseline HBV DNA is defined as the last pre-dose assessment of HBV DNA.HBV DNA reductions, considered as the repeated measures, from baseline to Weeks 2, 4, 8.|Baseline (day 1) to Weeks 2, 4, 8|Intent to Treat (ITT) population included all patients who received at least one dose of study drug and had at least one post-baseline assessment of serum HBV DNA. The randomized treatment was used in the analyses of this population.||log10 copies/mL||Standard Deviation|Mean
732716|NCT00412529|Primary|Change in Mean Hepatitis B Virus (HBV) DNA Levels|Baseline HBV DNA is defined as the last pre-dose assessment of HBV DNA.|Baseline (day 1) to Week 12 (day 85)|Intent to Treat (ITT) population included all patients who received at least one dose of study drug and had at least one post-baseline assessment of serum HBV DNA. The randomized treatment was used in the analyses of this population.||log10 copies/mL||Standard Deviation|Mean
732717|NCT00412542|Primary|Number of Participants Progression Free at 6 Months With Malignant Gliomas|Progression-free Survival (PFS) measured as number of participants that are alive and progression-free at 6 months.|6 Months|7 participants enrolled were not evaluated as they were evaluable for toxicity only (not having completed the first cycle/clinical decline/etc.).||participants|||Number
732718|NCT00412607|Secondary|Change in Left Ventricular Ejection Fraction at 6 Month From Baseline|Change in Left Ventricular Ejection Fraction (LVEF) from baseline to 6 month follow up. LVEF is a measure of the percentage of blood leaving heart each time it contracts. Baseline LVEF data were collected at pre ablation procedure, at hospital discharge, and at the 6-month follow-up visit.|6-month follow up|Efficacy analysis cohort subjects with LVEF data available. The statistics for Baseline and 6-month were based on data available from 219 and 166 subjects respectively; the mean change was based on 163 subjects with data at both Baseline and 6-month. Hence the mean change is not the simple subtraction between Baseline and 6-month.||percentage of blood leaving the heart||Standard Deviation|Mean
732719|NCT00412607|Secondary|Number of Subjects Achieved Long-term Efficacy Success|Long-term success is defined as patient-reported non-recurrence of Ventricular Tachycardia (VT) at the12-month, second year, and third year phone follow-ups.|3-year follow up|Subjects in the efficacy analysis cohort who completed 12-month, 2-year, or 3-year follow-up and had available long-term efficacy outcomes at the corresponding time points were included.||participants|||Number
732720|NCT00412607|Secondary|Percentage of Subjects Who Achieved Chronic Effectiveness|Chronic effectiveness is defined as subjects without recurrence of sustained monomorphic ventricular tachycardia (SMVT) at 6 month follow-up. For subjects with Implantable Cardioverter Defibrillator (ICD), recurrences of SMVT were defined as appropriate ICD shock therapies. For subjects without ICDs, recurrences of SMVT were recorded in the follow-up visits form. Besides SMVT, recurrence of incessant VT was also captured in this study. Recurrence of incessant VT was recorded up to 6 month post ablation procedure but not beyond.|6-month follow up|Subjects in the Efficacy analysis cohort who had available chronic effectiveness outcomes were included||Percentage of participants|||Number
733345|NCT00410813|Secondary|Change in Serum Bone Turnover Markers Over Time -- NTx|Analysis included mean values of the serum biomarker NTx at baseline, 4, and 8 weeks.|at baseline, 4, and 8 weeks|Number of patients with samples to analyze: baseline n=66, 4 weeks n=54, 8 weeks n=52.||nM BCE||Standard Deviation|Mean
732721|NCT00412607|Primary|The Percentage of Subjects Who Experienced Cardiovascular-specific Adverse Events (CSAE) Within Seven Days of the Ablation Procedure.|The acute primary safety endpoint is the percentage of subjects who experienced cardiovascular-specific adverse events (CSAE) within seven days of the ablation procedure.|Seven days post ablation procedure|Safety Analysis Cohort - defined as subjects who underwent insertion of the study catheter.||percentage of Adverse Event||95% Confidence Interval|Number
732722|NCT00412607|Secondary|Percentage of Subjects Achieved Acute Success|Acute success was defined as the subjects receiving successful ablation of all targeted Ventricular Tachycardia (VT) and no recurrence prior to hospital discharge.|Duration from post-procedure to hospital discharge, up to 2 days|Subjects in the efficacy analysis cohort who had targeted ventricular tachycardia ablated were included. Efficacy Analysis Cohort includes subjects who are enrolled and treated with the study catheter in compliance with the protocol and treated specifically for the study-related arrhythmia.||Percentage of participants|||Number
732723|NCT00412607|Primary|The Percentage of Subjects That Expire From All-cause Mortality Within 12-months Post Ablation.|The long-term primary safety endpoint is the percentage of subjects that expire from all-cause mortality within 12-months post ablation.|12-month post ablation|Safety analysis population - subjects who underwent insertion of the study catheter.||percentage of mortality||95% Confidence Interval|Number
732724|NCT00412737|Secondary|Number of Participants With RT-PCR, or Serology/Viral Culture Confirmed Clinical Influenza, ITTNAB Population|RT-PCR, or serology/viral culture confirmed clinical influenza was defined as a confirmation of influenza by positive RT-PCR or culture within 2 days of symptoms/ last dose and/or positive serology result from baseline to any point during the study.|From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)|ITTNAB population.||participants|||Number
732725|NCT00412737|Secondary|Number of Participants With RT-PCR, or Serology/Viral Culture Confirmed Clinical Influenza, ITT Population|RT-PCR, or serology/viral culture confirmed clinical influenza was defined as a confirmation of influenza by positive RT-PCR or culture within 2 days of symptoms/ last dose and/or positive serology result from baseline to any point during the study.|From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)|ITT population.||participants|||Number
732726|NCT00412737|Secondary|Number of Participants With RT-PCR Confirmed Clinical Influenza, ITTNAB Population|RT-PCR confirmed clinical influenza was defined as a confirmation of influenza by positive RT-PCR result within 2 days of symptoms/last dose from baseline to any point during the study.|From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)|ITTNAB population.||participants|||Number
732727|NCT00412737|Secondary|Number of Participants With Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) Confirmed Clinical Influenza, ITT Population|RT-PCR confirmed clinical influenza was defined as a confirmation of influenza by positive RT-PCR result within 2 days of symptoms/last dose from baseline to any point during the study.|From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)|ITT population.||participants|||Number
732728|NCT00412737|Secondary|Number of Participants With Laboratory Confirmed Clinical Influenza, Intent-to-treat Virus Negative at Baseline (ITTNAB) Population|Laboratory-confirmed clinical influenza was defined as a fever (oral or otic temperature greater than 37.2 °C) and a symptom score for cough and/or coryza (nasal congestion on the diary cards, where 0=absent, 1=mild, 2=moderate, and 3=severe) of 1, 2 or 3 on the same day as fever, and laboratory confirmation of influenza either by detection of viral shedding by viral culture from nasopharyngeal swabs within two days of fever and symptoms, and/or by 4-fold or greater increase in serum HAI titers measured from baseline to any point during the study.|From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)|ITTNAB population was defined as the subset of the ITT population who were culture negative at baseline.||participants|||Number
732729|NCT00412737|Secondary|Number of Participants With Laboratory Confirmed Clinical Influenza, Per Protocol (PP) Population|Laboratory-confirmed clinical influenza was defined as a fever (oral or otic temperature greater than 37.2 °C) and a symptom score for cough and/or coryza (nasal congestion on the diary cards, where 0=absent, 1=mild, 2=moderate, and 3=severe) of 1, 2 or 3 on the same day as fever, and laboratory confirmation of influenza either by detection of viral shedding by viral culture from nasopharyngeal swabs within two days of fever and symptoms, and/or by 4-fold or greater increase in serum HAI titers measured from baseline to any point during the study.|From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)|Per-Protocol (PP) population was defined as the subset of the ITT population who did not have any major protocol violations which would impact the assessment of efficacy.||participants|||Number
732730|NCT00412737|Primary|Number of Participants With Laboratory-Confirmed Clinical Influenza, ITT Population|Laboratory-confirmed clinical influenza was defined as a fever (oral or otic temperature greater than [>] 37.2 degrees Celsius [°C]) and a symptom score for cough and/or coryza (nasal congestion on the diary cards, where 0=absent, 1=mild, 2=moderate, and 3=severe) of 1, 2 or 3 on the same day as fever, and laboratory confirmation of influenza either by detection of viral shedding by viral culture from nasopharyngeal swabs within two days of fever and symptoms, and/or by 4-fold or greater increase in serum hemagglutination inhibition (HAI) titers measured from baseline to any point during the study.|From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)|ITT population included all randomized participants who received at least 1 dose of study drug and had at least 1 post baseline efficacy assessment. Participants were analyzed as per initial randomization.||participants|||Number
732731|NCT00412750|Primary|Percentage of Participants With HBV DNA Non-detectability and Alanine Aminotransferase (ALT) Normalization at Week 12 and Week 24 in Participants With HBeAg-positive Chronic Hepatitis B (CHB)|The percentage of participants who achieved HBV DNA non-detectability using the COBAS Amplicor HBV Monitor assay utilizing polymerase chain reaction (PCR) (threshold for detection 300 copies/mL) and Alanine aminotransferase (ALT) normalization defined as ALT within normal limits on two successive visits for a patient with an elevated ALT (>1.0 x upper limit normal) at baseline summarized at Weeks 12 and 24.|Weeks 12 and 24|"Intent to Treat (ITT) population. The study was terminated and some participants did not complete all visits. n in each of the categories represents the number of participants in each arm with non-missing efficacy endpoint observations for the respective week."||Percentage of participants|||Number
733754|NCT00422383|Secondary|Change From BL in Complement C3 Protein Level in g/L|The LLN of C3 protein was defined as <0.9 g/L.|BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint||g/L||Standard Deviation|Mean
732732|NCT00412750|Secondary|Percentage of Participants Who Achieved HBV DNA Non-detectability With Peginterferon Alpha-2a Plus Telbivudine Combination Therapy Versus Telbivudine Monotherapy|Antiviral efficacy was assessed by percentage of patients achieving HBV DNA non-detectability assay utilizing polymerase chain reaction (PCR) (threshold for detection 300 copies/mL); however, this analysis was not performed due to premature study termination.|Week 52|The analysis was planned on intent to treat (ITT) population. Due to premature study termination, the analysis was not performed.||percentage of participants|||Number
732733|NCT00412750|Secondary|Percentage of Participants Who Achieved HBV DNA Non-detectability With Telbivudine Monotherapy Versus Peginterferon Alpha-2a Monotherapy|Antiviral efficacy was assessed by percentage of patients achieving HBV DNA non-detectability assay utilizing polymerase chain reaction (PCR) (threshold for detection 300 copies/mL); however, this analysis was not performed due to premature study termination.|Week 52|The analysis was planned on intent to treat (ITT) population. Due to premature study termination, the analysis was not performed.||Percentage of participants|||Number
732734|NCT00412750|Secondary|Percentage of Participants With Hepatitis B 'e' Antigen (HBeAg) Loss and HBeAg Seroconversion|HBeAg loss is defined as the loss of detectable serum HBeAg in a patient who was HBeAg positive at baseline. HBeAg seroconversion is defined as HBeAg loss with detectable Hepatitis B ‘e’ antibody (HBeAb). The efficacy was assessed for 18 weeks, 24 weeks, 48 weeks, 52 weeks and on treatment completion (TC).|Weeks 18, 24, 48, 52 and Treatment completion (TC)|"Intent to Treat (ITT) population. The study was terminated and some participants did not complete all visits. n in each of the categories represents the number of participants in each arm with non-missing efficacy endpoint observations for the respective week and on treatment completion (TC)."||Percentage of participants|||Number
732735|NCT00412750|Secondary|Percentage of Participants Who Experienced Virologic Breakthrough at Weeks 48 and 52|The percentage of participants with Virologic breakthrough at Week 48 and 52 by treatment. For the subgroup of patients on treatment who achieve HBV DNA >= 1 log10 copies/mL reduction from baseline on 2 consecutive visits, Virologic Breakthrough is defined as HBV DNA >= 1 log10 copies/mL from nadir on two consecutive visits.|Weeks 48 and 52|Intent to treat (ITT) population. As most patients did not reach Week 48 and Week 52, the LOCF was used.||Percentage of participants|||Number
732736|NCT00412750|Secondary|Change From Baseline in HBV DNA Concentration|The change from baseline in HBV DNA concentration at Weeks 12 and 24 was analyzed using an analysis of covariance (ANCOVA) model with baseline HBV DNA concentration (log10 copies/ml) as a covariate, treatment and country as factors.|Weeks 12 and 24|Intent to Treat (ITT) population. n= the number of patients who have both baseline and post baseline observation for the respective week||log 10 copies/ml||Standard Error|Least Squares Mean
732737|NCT00412750|Primary|Percentage of Participants Who Achieved HBV DNA Non-detectability With Peginterferon Alpha-2a Plus Telbivudine Combination Therapy Versus Peginterferon Alpha-2a Monotherapy|The original primary efficacy variable was the percentage of patients achieving HBV DNA non-detectability utilizing polymerase chain reaction (PCR) (threshold for detection 300 copies/mL); however, this analysis was not performed due to premature study termination.|At week 52|The analysis was planned on intention to treat (ITT) population. Due to premature study termination, the analysis was not performed.||Percentage of participants|||Number
732738|NCT00412841|Secondary|To Determine if Atorvastatin Has an Anti-inflammatory Effect in Active SLE That Reduces Biological Markers of the Inflammatory Process (ESR, Hs-CRP) and Reduces Disease Activity Assessed by Serology (C3, C4, Anti-dsDNA) or Clinical Instrument (SLEDAI)||6 years||||||
732739|NCT00412841|Secondary|To Determine if Atorvastatin is Effective in Lowering Serum Lipid Levels Chol, TG, HDL, & LDL in SLE Patients||6 years||||||
732740|NCT00412841|Secondary|Number of Participants With AVN After 4 Months||4 months|||participants|||Number
732741|NCT00412841|Primary|Number of Participants With AVN After 9 Months||9 months|||participants|||Number
732742|NCT00412854|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From receipt of first dose of study vaccine (Day 0) to study end (Month 3)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine administration documented.||Subjects|||Number
732743|NCT00412854|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Day 0-30) follow-up period after each vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine administration documented.||Subjects|||Number
732744|NCT00412854|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, fever [defined as axillary temperature equal to or above (≥) 37.1 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever above (>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 4-day (Day 0-3) follow-up period after each vaccine dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine administration documented and with the symptoms sheet filled in.||Subjects|||Number
732745|NCT00412854|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.|During the 4-day (Day 0-3) follow-up period after each vaccine dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine administration documented and with the symptoms sheet filled in.||Subjects|||Number
734282|NCT00425308|Secondary|Assessing Cardiovascular Risk Factors Based on Fasting C-reactive Protein (CRP).|Blood chemistry - C-reactive Protein (CRP) (mg/L)|From Baseline to Month 3, 6, and 12|Safety population||mg/L||Standard Deviation|Mean
732746|NCT00412854|Secondary|Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies|Anti-PT, anti-FHA and anti-PRN antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).|At Month 3|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||EL.U/mL||95% Confidence Interval|Geometric Mean
732747|NCT00412854|Secondary|Concentrations for Anti-PRP Antibodies|Anti-PRP antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in microgram/milliliter (µg/mL).|At Month 0 and Month 3|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||µg/mL||95% Confidence Interval|Geometric Mean
732748|NCT00412854|Secondary|Concentrations for Anti-D and Anti-T Antibodies|Anti-D and anti-T antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in International units per milliliter (IU/mL).|At Month 0 and Month 3|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||IU/mL||95% Confidence Interval|Geometric Mean
732749|NCT00412854|Secondary|Number of Subjects With Anti-PRP Antibody Concentrations ≥ 1.0 µg/mL|The number of subjects with anti-PRP antibody concentrations higher than or equal to (≥) 1.0 µg/mL post primary vaccination is reported.|At Month 3|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
732750|NCT00412854|Primary|Number of Subjects With a Vaccine Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antibodies|"The vaccine response was defined as it follows:
for PT and FHA, an antibody concentration higher than or equal to (≥) 20 EL.U/mL at post-vaccination;
for PRN, at least a 4-fold increase in antibody concentration from pre-vaccination to post-vaccination time points."|At Month 3|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
732751|NCT00412854|Primary|Number of Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (PRP)|A seroprotected subject was defined as a vaccinated subject with an anti-PRP antibody concentration higher than or equal to (≥) 0.15 microgram/milliliter (µg/mL).|At Month 3|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
732752|NCT00412854|Primary|Number of Seroprotected Subjects Against Diphteria Toxoid (D) and Tetanus Toxoid (T)|A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations higher than or equal to (≥) 0.1 international units per milliliter (IU/mL).|At Month 3|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
732753|NCT00412867|Secondary|Safety||3 months||||||
732754|NCT00412867|Secondary|Barthel Index (BI)||the day of discharge within 3 months after onset, and 3 months after onset||||||
732755|NCT00412867|Secondary|National Institutes of Health Stroke Scale (NIHSS) Score||within 6 hours, from 24 to 36 hours, 3 months after onset, etc.||||||
732756|NCT00412867|Primary|Number of Patients With Symptomatic Intracranial Hemorrhage (sICH) Within 36 Hours|The number of patients with sICH|within 36 hours after starting treatment|||participants|||Number
732757|NCT00412867|Primary|Number of Patients With a Modified Rankin Scale (mRS) Score of 0-1 a 3 Months|The number of patients with an mRS score of 0-1. The mRS has 6 items, where 0 = No symptoms at all, 1 = No significant disability despite symptoms, 2 = Slight disability, 3 = Moderate disability, 4 = Moderately severe disability, 5 = Severe disability. The higher scores reflect increased disability.|3 months after onset|||participants|||Number
732758|NCT00412867|Primary|Number of Patients With Valid Recanalization Assessed by Magnetic Resonance Angiography (MRA)|"Recanalization was evaluated according to the modified Mori grade: Grade 0, no reperfusion; Grade 1, movement of thrombus not associated with any flow improvement; Grade 2, partial (branch) recanalization in <50% of the branches in the occluded-arterial territory; Grade 3, nearly complete recanalization with reperfusion in ≥50% of the branches in the occluded-arterial territory.
The recanalization rate was estimated by regarding Grades 2 and 3 as valid recanalization."|within 6 hours, from 24 to 36 hours after onset|||participants|||Number
732759|NCT00412893|Secondary|Number of Participants With Adverse Events, Reported by System Organ Class||From the first study drug administration until 28 days after the last dose of study drug. The median duration of study drug administration was 45 days.|The safety analysis set consists of all randomized patients who received at least one dose of study drug according to the study drug that the participant actually received as the first dose. One participant was randomized to isavuconazole but received voriconazole treatment for the first 7 days and is included in the voriconazole arm for safety.||participants|||Number
732837|NCT00413153|Primary|Glucose Trafficking|"6 month mean and standard deviation for glucose uptake into anterior thigh muscle as measured by FDG/PET scanning during euglycemic hyperinsulinemic clamp. During the hyperinsulinemic conditions of the clamp, glucose and 18-FDG [labeled glucose] are taken up by muscle. The quantity of 18-FDG taken up is measured by the PET scan. Although there are no well-accepted norms for this measurement, a higher value indicates that more glucose is being taken up by (or trafficked to) muscle. Increased uptake of glucose indicates increased muscle insulin sensitivity."|6 months|Only data from subjects with 0 and 6 month Positron Emission Tomography (PET) scans were analyzed.||umol/kg/min||Standard Deviation|Mean
732760|NCT00412893|Secondary|Percentage of Participants With a Radiological Response Assessed by the Investigator|"Radiological assessments were performed by the investigator. Radiological response is defined as a ≥ 50% improvement from Baseline, or improvement of at least 25% from Baseline for the Day 42 analysis or if end of treatment occurred before Day 42. Failure is defined as a < 25% improvement at any time or results not available. Participants with no signs on radiological images at Baseline were considered Not Applicable. End of Treatment is the last day of study drug administration."|Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.|"Modified intent-to-treat population. Missing data for any participant at any visit was included as a failure. Participants with a Not Applicable assessment were excluded. The number of participants included in the analysis at each time point is indicated by n."||percentage of participants|||Number
732761|NCT00412893|Secondary|Percentage of Participants With a Mycological Response Assessed by the Investigator|"Mycological assessments of the participant’s invasive fungal disease status were performed by the investigator using the results from fungal culture and isolation and/or histology/cytology of biopsy or biological fluid samples from the infected site.
Mycological response is defined as eradication or presumed eradication of the original causative organism cultured or identified by histology/cytology at Baseline. Failure was defined as persistence or presumed persistence. Participants with no mycological evidence available at Baseline, or no mycological follow-up results available or indeterminate results were classified as Not Applicable.
End of treatment is the last day of study drug administration."|Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.|"Modified intent-to-treat population. Missing data for any participant at any visit was included as a failure; participants with a Not Applicable assessment were excluded. The number of participants included in the analysis at each time point in indicated by n."||percentage of participants|||Number
732762|NCT00412893|Secondary|Percentage of Participants With a Clinical Response Assessed by the Investigator|"Assessment of clinical symptoms and physical findings of invasive fungal disease were performed by the investigator.
Clinical response is defined as the resolution or partial resolution of all attributable clinical symptoms and physical findings. Failure is defined as no resolution of any attributable clinical symptoms and physical findings and/or worsening, or if results were unavailable or the participant was unevaluable. Participants with no attributable signs and symptoms present at Baseline were classified as Not Applicable. End of treatment is the last day of study drug administration."|Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.|"Modified intent-to-treat population. Missing data for any participant at any visit was included as a failure; participants with a Not Applicable assessment were excluded. The number of participants included in the analysis at each time point in indicated by n."||percentage of participants|||Number
732763|NCT00412893|Secondary|Percentage of Participants With a Radiological Response Assessed by the DRC|"Independent reviews of radiology assessments were completed by radiology experts which were provided to the independent, blinded DRC. Blinded radiological assessments were performed by the DRC.
Radiological response is defined as a ≥ 50% improvement from Baseline, or improvement of at least 25% from Baseline for the Day 42 analysis or if end of treatment occurred before Day 42. Participants without any radiology at Baseline were considered Not Applicable. End of Treatment is the last day of study drug administration."|Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.|"Modified intent-to-treat population. A participant with no post-baseline radiology data with evidence of radiologic disease at Baseline was considered a failure. Participants with a Not Applicable assessment were excluded. The number of participants included in the analysis at each time point is indicated by n."||percentage of participants|||Number
732764|NCT00412893|Secondary|Percentage of Participants With a Mycological Response Assessed by the DRC|"Blinded mycological assessments of the participant’s invasive fungal disease status were performed by the independent DRC using the results from fungal culture and isolation and/or histology/cytology of biopsy or biological fluid samples from the infected site.
Mycological response is defined as eradication or presumed eradication of the original causative organism cultured or identified by histology/cytology at Baseline. Failure was defined as persistence or presumed persistence. Participants with no mycological evidence available at Baseline were classified as Not Applicable.
End of treatment is the last day of study drug administration."|Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.|Modified intent-to-treat population. Any visits the DRC assessed as not done were considered as missing and included as a failure; participants with a Not Applicable assessment were excluded.||percentage of participants|||Number
732765|NCT00412893|Secondary|Percentage of Participants With a Clinical Response Assessed by the DRC|"Blinded assessments of clinical symptoms and physical findings of invasive fungal disease were performed by the independent DRC.
Clinical response is defined as the resolution or partial resolution of all attributable clinical symptoms and physical findings. Failure is defined as no resolution of any attributable clinical symptoms and physical findings and/or worsening. Participants with no attributable signs and symptoms present at Baseline and no symptoms attributable to invasive fungal disease (IFD) developed post-baseline were classified as Not Applicable. End of treatment is the last day of study drug administration."|Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.|"Modified intent-to-treat population. Any visits the DRC assessed as not done were considered as missing and included as a failure; participants with a Not Applicable assessment were excluded. The number of participants included in the analysis at each time point in indicated by n."||percentage of participants|||Number
732766|NCT00412893|Secondary|Percentage of Participants With an Overall Outcome of Success Evaluated by Investigator|Overall response based on investigators’ assessments was not derived as it was not deemed necessary because participants overall response status was determined by the DRC. All investigators' assessments of clinical, mycological and radiological responses are analyzed separately (see Outcome Measures 8-10).|Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.||||||
732767|NCT00412893|Secondary|All-cause Mortality Through Day 84|All-cause mortality is represented as the percentage of participants who died after first dose of study drug through Day 84 from any cause. Participants with unknown survival status through Day 84 were included as deaths in the calculation.|Through Day 84|Intent-to-treat population||percentage of participants|||Number
734283|NCT00425308|Secondary|Assessing Cardiovascular Risk Factors Based on Fasting Triglycerides.||From Baseline to Month 1, 3, 6, 9, and 12|Safety population||mmol/L||Standard Deviation|Mean
732768|NCT00412893|Secondary|Percentage of Participants With an Overall Outcome of Success Evaluated by the Data Review Committee (DRC)|"The DRC was an independent, blinded committee consisting of experts in the field of infectious disease who assessed patients' outcomes. The overall response was based on the DRC-assessed clinical, mycological and radiological responses.
Success was defined as the resolution or partial resolution of all attributable clinical symptoms and physical findings, the eradication or presumed eradication of the original causative organism cultured or identified by histology/cytology at Baseline and a > 50% improvement in radiological response from Baseline (or improvement of at least 25% from Baseline for the Day 42 analysis or End of Treatment if it occurred prior to Day 42).
End of treatment (EOT) is the last day of study drug administration. For the Day 42 and Day 84 analyses, any visits that the DRC assessed as Not Done were considered a failure for that visit. A death before Day 42 was also considered a failure, even if the DRC assessed the participant to be a success prior to death."|Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.|Modified Intent-to-treat (mITT) population consisted of ITT participants who had proven or probable IFD as determined by the DRC.||percentage of participants|||Number
732769|NCT00412893|Primary|All-cause Mortality Through Day 42|All-cause mortality is represented as the percentage of participants who died after first dose of study drug through Day 42 from any cause. Participants with unknown survival status through Day 42 were included as deaths in the calculation.|Through Day 42|Intent-to-treat population||percentage of participants|||Number
732770|NCT00412932|Secondary|Number of Subjects Who Achieved Mean Nighttime (10pm - 6am) Ambulatory Blood Pressure of <140/90 mm Hg, Systolic Blood Pressure <140 mm Hg, and Diastolic Blood Pressure <90 mm Hg After 12 Weeks of Active Treatment.|All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements.|baseline to 12 weeks|178 participants started the active treatment period. 23 dropped out. 150=The ambulatory blood pressure monitoring (ABPM) subset was defined as subjects who received at least one dose of active study medication and had a baseline and week 12 ABPM.||participants|||Number
732771|NCT00412932|Secondary|Number of Subjects Who Achieved Mean Daytime (8am - 4pm) Ambulatory Blood Pressure of <140/90 mm Hg, Systolic Blood Pressure <140 mm Hg, and Diastolic Blood Pressure <90 mm Hg After 12 Weeks of Active Treatment.|All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements.|baseline to 12 weeks|178 participants started the active treatment period. 23 dropped out. 150=The ambulatory blood pressure monitoring (ABPM) subset was defined as subjects who received at least one dose of active study medication and had a baseline and week 12 ABPM.||participants|||Number
732772|NCT00412932|Secondary|Number of Subjects Who Achieved Mean 24-hour Ambluatory Blood Pressure of <140/90 mm Hg, Systolic Blood Pressure <140 mm Hg, and Diastolic Blood Pressure <90 mm Hg After 12 Weeks of Active Treatment|All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements.|baseline to 12 weeks|178 participants started the active treatment period. 23 dropped out. 150=The ambulatory blood pressure monitoring (ABPM) subset was defined as subjects who received at least one dose of active study medication and had a baseline and week 12 ABPM.||participants|||Number
732773|NCT00412932|Secondary|Change From Baseline in Mean Daytime (8am-4pm) and Mean Nighttime (10 Pm-6am) Ambulatory Blood Pressure Monitored Diastolic Blood Pressure After 12 Weeks of Active Treatment|All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements.|baseline to 12 weeks|178 participants started the active treatment period. 23 dropped out. 150=The ambulatory blood pressure monitoring (ABPM) subset was defined as subjects who received at least one dose of active study medication and had baseline and week 12 ABPM measurements.||mm Hg||Standard Error|Mean
732774|NCT00412932|Secondary|Change From Baseline in Mean Daytime (8am-4pm) and Mean Nighttime (10pm-6am)Ambulatory Systolic Blood Pressure After 12 Weeks of Active Treatment|All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements.|baseline to 12 weeks|178 participants started the active treatment period. 23 dropped out. 150=The ambulatory blood pressure monitoring (ABPM) subset was defined as subjects who received at least one dose of active study medication and had a baseline and week 12 ABPM.||mm Hg||Standard Error|Mean
732807|NCT00413010|Primary|Change in Hamilton Anxiety Rating Scale (HAM-A) Total Scores|Change from baseline: average across visit weeks using mixed model. HAM-A=clinician-rated interview measuring presence of anxiety-related symptoms in 14 areas including anxiety, tension, depressed mood, palpitations, breathing difficulties, sleep disturbances, & restlessness. Total score ranges from 0 to 56; higher score indicates greater anxiety.|Baseline, 8 weeks|Intent-to-Treat (ITT) population included all randomized subjects who had received at least 1 dose of the double-blind treatment. All efficacy analyses included the ITT subjects who had a Baseline and a post-Baseline assessment of the respective efficacy endpoints.||score on scale||Standard Error|Least Squares Mean
732775|NCT00412932|Secondary|Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure After 12 Weeks of Active Treatment.|All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements.|baseline to 12 weeks|178 participants started the active treatment period. 23 dropped out. 150=The ambulatory blood pressure monitoring (ABPM) subset was defined as subjects who received at least one dose of active study medication and had a baseline and week 12 ABPM.||mm Hg||Standard Error|Mean
732776|NCT00412932|Primary|Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure After 12 Weeks of Active Treatment|All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements.|baseline to 12 weeks|178 participants started the active treatment period. 23 dropped out. 150=The ambulatory blood pressure monitoring (ABPM) subset was defined as subjects who received at least one dose of active study medication and had a baseline and week 12 ABPM.||mm Hg||Standard Error|Mean
732777|NCT00412958|Primary|Proportion of Patients Achieving Total Posterior Vitreous Detachment (PVD) Without Creation of an Anatomical Defect|The primary efficacy endpoint was the proportion of patients achieving total PVD without creation of an anatomical defect (ie, retinal hole, retinal detachment) based on surgeon visualization at the beginning of vitrectomy prior to suction or any other mechanical intervention.|Day 7|Intent-To-Treat (ITT). Full Analysis Set.||percentage of participants|||Number
732778|NCT00412971|Secondary|False Positive Detection Rate Patient Level||12 months|||percent of patients|||Number
732779|NCT00412971|Secondary|Proportion of Patients in the Hexvix Cystoscopy Group Who Had at Least One Additional Lesion Found by Hexvix Cystoscopy That Was Not Found by White Light Cystoscopy.||At day 0|ITT||percentage of participants||95% Confidence Interval|Number
732780|NCT00412971|Primary|Proportion of Patients With Histologically Confirmed Recurrence Within One 1 Year.|To compare tumour recurrence rates after standard (white light) and fluorescence guided transurethral resection of the bladder (TURB) in patients with macroscopic non-muscle invasive bladder tumour.|1 year|PP. 145 patients were eligible for tumor recurrence. 12 patients has their last follow up after 12 months. Recurrence after 12 months is based on a total of 133 patients.||precentage of participants||95% Confidence Interval|Number
732781|NCT00412984|Other Pre-specified|Rate of Net-Clinical Benefit During Treatment Period|Rate=number of events of net-clinical benefit per 100 patient years. Net-Clinical Benefit = Composite of stroke, systemic embolism and ISTH major bleeding|"Treatment Period started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group."|Treated participants. Participants who did not experience a bleeding endpoint were censored at the earlier of 2 days after discontinuation of study drug, or death date, or last-contact date (for participants who withdrew consent to be followed up or were lost to follow-up) at the end of the study.||Number of events per 100 patient years|||Number
732782|NCT00412984|Other Pre-specified|Number of Participants With Net-Clinical Benefit During Treatment Period|Net-Clinical Benefit = Composite of stroke, systemic embolism and ISTH major bleeding.|"Treatment Period started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group."|Treated participants. Participants who did not experience a bleeding endpoint were censored at the earlier of 2 days after discontinuation of study drug, or death date, or last-contact date (for participants who withdrew consent to be followed up or were lost to follow-up) at the end of the study.||participants|||Number
732783|NCT00412984|Other Pre-specified|Rate of Adjudicated Bleeding Endpoints Per Thrombolysis in Myocardial Infarction (TIMI) During the Treatment Period|Rate=number of adjudicated TIMI bleeding events per 100 patient years. TIMI Bleeding Criteria: Major bleeding=Intracranial bleeding and/or clinically overt bleeding associated with ≥5 gm/dL fall in Hgb or 15% fall in hematocrit (Hct) from baseline, accounting for transfusions. Minor bleeding=Clinically overt bleeding associated with ≥3 gm/dL fall in Hgb or a ≥10% fall in Hct from baseline, accounting for transfusions.|"Treatment Period started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group."|Treated participants. Participants who did not experience a bleeding endpoint were censored at the earlier of 2 days after discontinuation of study drug, or death date, or last-contact date (for participants who withdrew consent to be followed up or were lost to follow-up) at the end of the study. n=number of participants experiencing events.||Number of events per 100 patient years|||Number
732784|NCT00412984|Other Pre-specified|Rate of Adjudicated Bleeding Endpoints Per Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) During the Treatment Period|Rate=number of adjudicated GUSTO bleeding events per 100 patient years. GUSTO Bleeding Criteria: GUSTO severe (or life-threatening) bleeding: either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention. GUSTO moderate bleeding: bleeding that requires blood transfusion but does not result in hemodynamic compromise.|"Treatment Period started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group."|Treated participants. Participants who did not experience a bleeding endpoint were censored at the earlier of 2 days after discontinuation of study drug, or death date, or last-contact date (for participants who withdrew consent to be followed up or were lost to follow-up) at the end of the study. n=number of participants experiencing events.||Number of events per 100 patient years|||Number
732833|NCT00413153|Secondary|Body Composition - Visceral Adipose Tissue|6 month mean and standard deviation for visceral adipose tissue (VAT) as measured by single slice computed tomography (CT) scan at the L4 pedicle (pedicle of 4th lumbar vertebra).|6 months|Data from participants with 0 & 6 month data analyzed.||square centimeters||Standard Deviation|Mean
732785|NCT00412984|Secondary|Rate of All Bleeding Events During Treatment Period|"Rate=number of all bleeding events per 100 patient years. All bleeding events include major bleeding, CRNM bleeding (see Outcome Measure 12 Description for definitions), plus events of minor bleeding and fatal bleeding. Minor bleeding: All acute clinically overt bleeding events not meeting the criteria for either major bleeding or clinically relevant non-major bleeding will be classified as minor bleeding. Fatal bleeding is defined as a bleeding event that the Clinical Events Committee determines is the primary cause of death or contributes directly to death."|"Treatment Period started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group."|Treated participants. Participants who did not experience a bleeding endpoint were censored at the earlier of 2 days after discontinuation of study drug, or death date, or last-contact date (for participants who withdrew consent to be followed up or were lost to follow-up) at the end of the study.||number of events per 100 patient years|||Number
732786|NCT00412984|Secondary|Number of Participants With All Bleeding Events During Treatment Period|All bleeding events include major bleeding, CRNM bleeding (see Outcome Measure 12 Description for definitions), plus events of minor bleeding and fatal bleeding. Minor bleeding: All acute clinically overt bleeding events not meeting the criteria for either major bleeding or clinically relevant non-major bleeding will be classified as minor bleeding. Fatal bleeding is defined as a bleeding event that the Clinical Events Committee determines is the primary cause of death or contributes directly to death.|"Treatment Period started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group."|Treated participants. Participants who did not experience a bleeding endpoint were censored at the earlier of 2 days after discontinuation of study drug, or death date, or last-contact date (for participants who withdrew consent to be followed up or were lost to follow-up) at the end of the study.||participants|||Number
732787|NCT00412984|Secondary|Rate of Events of Major or Clinically Relevant Non-Major (CRNM) Bleed During Treatment Period|Rate=number of major or CRNM bleed events per 100 patient years. Major=clinically overt and either 1) resulted in a decrease in hemoglobin of 2 g/dL or more over a 24-hour period, or 2) led to a transfusion of 2 or more units of packed red blood cells, or 3) occurred in a critical site, or 4) led to death. CRNM bleeding=clinically overt, but satisfied no additional criteria required to be adjudicated as a major bleeding event, and led to either 1) hospital admission for bleeding or 2) physician guided medical or surgical treatment for bleeding or 3) a change in antithrombotic therapy.|"Treatment Period started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group."|Treated participants. Participants who did not experience a bleeding endpoint were censored at the earlier of 2 days after discontinuation of study drug, or death date, or last-contact date (for participants who withdrew consent to be followed up or were lost to follow-up) at the end of the study.||number of events / 100 patient years|||Number
732788|NCT00412984|Secondary|Number of Participants With Events of Major or Clinically Relevant Nonmajor (CRNM) Bleed During Treatment Period|Major bleeding=bleeding that is clinically overt and that either resulted in a decrease in hemoglobin of 2 g/dL or more over a 24-hour period, led to a transfusion of 2 or more units of packed red blood cells, occurred in a critical site, or led to death. CRNM bleeding=bleeding that is clinically overt, that satisfies none of the additional criteria required for the event to be adjudicated as a major bleeding event, that led to either hospital admission for bleeding, physician-guided medical or surgical treatment for bleeding, or a change in antithrombotic therapy.|"Treatment Period started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group."|Treated participants. Participants who did not experience a bleeding endpoint were censored at the earlier of 2 days after discontinuation of study drug, or death date, or last-contact date (for participants who withdrew consent to be followed up or were lost to follow-up) at the end of the study.||participants|||Number
732789|NCT00412984|Other Pre-specified|Number of Participants With Adverse Events (AEs), Bleeding AEs, Serious Adverse Events (SAEs), Discontinuations Due to AEs, or Deaths During the Treatment Period|AE: all SAEs or AEs with onset from first dose through 2 days (AEs) or 30 days (SAEs) after the last dose of blinded study drug (BSD). SAE: all SAEs with onset from first dose through 30 days after the last dose of BSD. Bleeding AE: all serious or non-serious bleeding-related AEs with onset from first dose through 2 days after the last dose of BSD. Discontinuations due to AE: all SAEs or AEs with onset from first dose of BSD and with action taken=drug discontinued. Deaths: all deaths occurring from first dose through 30 days after the last dose of BSD.|"Treatment Period started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group."|Treated participants. Participants who did not experience a bleeding endpoint were censored at the earlier of 2 days after discontinuation of study drug, or death date, or last-contact date (for participants who withdrew consent to be followed up or were lost to follow-up) at the end of the study.||participants|||Number
732790|NCT00412984|Secondary|Rate of Composite Stroke / Systemic Embolism / Major Bleeding in Warfarin/Vitamin K Antagonist (VKA) Naive Participants During the Intended Treatment Period||"Intended Treatment Period started on the day of randomization and ended at the efficacy cut-off date (date on which it was expected that the target number of primary efficacy events [448] would have occurred; set to 30-Jan-2011, prior to unblinding)."|Intention to treat analysis, randomized participants. Participants who did not experience an efficacy endpoint event were censored at the earlier of their death date, last contact date, or the efficacy cut-off date (30-Jan-2011).||Number of events per 100 patient years|||Number
732791|NCT00412984|Secondary|Number of Warfarin/Vitamin K Antagonist (VKA) Naive Participants With Composite Stroke / Systemic Embolism (SE) / Major Bleeding During the Intended Treatment Period|For descriptions of Stroke and SE, see Outcome Measure 1. For description of Major bleeding, see Outcome Measure 3.|"Intended Treatment Period started on the day of randomization and ended at the efficacy cut-off date (date on which it was expected that the target number of primary efficacy events [448] would have occurred; set to 30-Jan-2011, prior to unblinding)."|Intention to treat analysis, randomized participants who were Warfarin/Vitamin K Antagonist (VKA) naïve (a stratification variable, defined as receiving ≤30 consecutive days of prior warfarin/VKA treatment). Participants not experiencing efficacy endpoint event were censored at earlier of death, last contact, or efficacy cut-off date (30-Jan-2011).||participants|||Number
732792|NCT00412984|Secondary|Rate of Ischemic or Unspecified Stroke, Hemorrhagic Stroke, Systemic Embolism (SE), Myocardial Infarction (MI) and All-Cause Death (ACD) (as Composite Endpoints) During the Intended Treatment Period|Diagnosis for an acute or evolving MI=elevation of CK-MB or Troponin T or I ≥ 2 × the ULN, or if no CK-MB or troponin values are available, a total CK ≥ 2×ULN, or new, significant (≥0.04 s) Q waves in ≥2 contiguous leads. For descriptions of Stroke and SE, see Outcome Measure 1. For description of ACD, see Outcome Measure 5.|"Intended Treatment Period started on the day of randomization and ended at the efficacy cut-off date (date on which it was expected that the target number of primary efficacy events [448] would have occurred; set to 30-Jan-2011, prior to unblinding)."|Intention to treat analysis, randomized participants. Participants who didn't experience an efficacy endpoint event were censored at the earlier of their death date (when death is not part of the endpoint), last contact date, or the efficacy cut-off date (30-Jan-2011). n= number of participants experiencing stated combination of events.||Number of events per 100 patient years|||Number
732793|NCT00412984|Secondary|Rate of Ischemic or Unspecified Stroke, Hemorrhagic Stroke, Systemic Embolism (SE), and Myocardial Infarction (MI) (as Individual Endpoints) During the Intended Treatment Period|Diagnosis for an acute or evolving MI=elevation of creatine kinase-MB isoenzyme (CK-MB) or Troponin T or I ≥ 2 × the upper limit of normal (ULN), or if no CK-MB or troponin values are available, a total CK ≥ 2×ULN, or new, significant (≥0.04 s) Q waves in ≥2 contiguous leads. For descriptions of Stroke and SE, see Outcome Measure 1.|"Intended Treatment Period started on the day of randomization and ended at the efficacy cut-off date (date on which it was expected that the target number of primary efficacy events [448] would have occurred; set to 30-Jan-2011, prior to unblinding)."|Intention to treat analysis, randomized participants. Participants who did not experience an efficacy endpoint event were censored at the earlier of their death date (when death is not part of the endpoint), last contact date, or the efficacy cut-off date (30-Jan-2011). n=number of participants experiencing stated event.||Number of events per 100 patient years|||Number
732794|NCT00412984|Secondary|Rate of Adjudicated All-Cause Death During the Intended Treatment Period|All unobserved deaths were assumed to be cardiovascular in nature unless a non-cardiovascular cause could be clearly provided. Cardiovascular=deaths due to ischemic and hemorrhagic stroke, SE, MI, sudden death, heart failure, other cardiovascular, and unobserved deaths. Non-cardiovascular=all deaths due to a clearly documented non-cardiovascular cause (further classified into the categories: bleeding, study drug toxicity other than bleeding, malignancy, infection, trauma, and pulmonary causes of death).|"Intended Treatment Period started on the day of randomization and ended at the efficacy cut-off date (date on which it was expected that the target number of primary efficacy events [448] would have occurred; set to 30-Jan-2011, prior to unblinding)."|Intention to treat analysis, randomized participants. Participants who did not experience an efficacy endpoint event were censored at the earlier of their death date (when death is not part of the endpoint), last contact date (for subjects who withdrew consent to be followed up or were lost to follow-up) or the efficacy cut-off date (30-Jan-2011).||Number of events per 100 patient years|||Number
732795|NCT00412984|Secondary|Number of Participants With Events of All-Cause Death During the Intended Treatment Period|Death was defined as all-cause mortality. All unobserved deaths were assumed to be cardiovascular in nature unless a non-cardiovascular cause could be clearly provided. Cardiovascular=deaths due to ischemic and hemorrhagic stroke, SE, myocardial infarction (MI), sudden death, heart failure, other cardiovascular, and unobserved deaths. Non-cardiovascular=all deaths due to a clearly documented non-cardiovascular cause (further classified into the categories: bleeding, study drug toxicity other than bleeding, malignancy, infection, trauma, and pulmonary causes of death).|"Intended Treatment Period started on the day of randomization and ended at the efficacy cut-off date (date on which it was expected that the target number of primary efficacy events [448] would have occurred; set to 30-Jan-2011, prior to unblinding)."|Intention to treat analysis, randomized participants. Participants who did not experience an efficacy endpoint event were censored at the earlier of their death date (when death is not part of the endpoint), last contact date (for subjects who withdrew consent to be followed up or were lost to follow-up) or the efficacy cut-off date (30-Jan-2011).||participants|||Number
732796|NCT00412984|Primary|Rate of Adjudicated Major (ISTH) Bleed Events During Treatment Period|Rate=number of adjudicated major (ISTH) bleed events per 100 patient years. ISTH Bleeding Criteria: Major bleeding=a bleeding event that was: clinically overt bleeding accompanied by a decrease in hemoglobin (Hgb) of 2 g/dL or more and/or a transfusion of 2 or more units of packed red blood cells; bleeding that occurred in at least 1 of the following sites: intracranial, intraspinal, intraocular (within the corpus of the eye; a conjunctival bleed is not an intraocular bleed), pericardial, intra-articular, intramuscular with compartment syndrome, and retroperitoneal; bleeding that was fatal.|"Treatment Period started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group."|Treated participants. Participants who did not experience a bleeding endpoint were censored at the earlier of 2 days after discontinuation of study drug, or death date, or last-contact date (for participants who withdrew consent to be followed up or were lost to follow-up) at the end of the study.||Number of events per 100 patient years|||Number
732797|NCT00412984|Primary|Number of Participants With Event of Major (International Society on Thrombosis and Hemostasis [ISTH]) Bleeding During Treatment Period|ISTH Bleeding Criteria: Major bleeding=a bleeding event that was: clinically overt bleeding accompanied by a decrease in hemoglobin (Hgb) of 2 g/dL or more over a 24-hour period and/or a transfusion of 2 or more units of packed red blood cells; bleeding that occurred in at least 1 of the following critical sites: intracranial, intraspinal, intraocular (within the corpus of the eye; a conjunctival bleed is not an intraocular bleed), pericardial, intra-articular, intramuscular with compartment syndrome, and retroperitoneal; bleeding that was fatal.|"Treatment Period started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group."|Treated participants. Participants who did not experience a bleeding endpoint were censored at the earlier of 2 days after discontinuation of study drug, or death date, or last-contact date (for participants who withdrew consent to be followed up or were lost to follow-up) at the end of the study.||participants|||Number
732834|NCT00413153|Secondary|Lipid Metabolism - Serum Triglyceride|6 month mean and standard deviation for serum triglyceride.|6 months|Repeated measures analysis using all available data points for each participant||mg/dL||Standard Deviation|Mean
732798|NCT00412984|Primary|Rate of Adjudicated Stroke or Systemic Embolism (SE) During the Intended Treatment Period|Rate=Number of adjudicated stroke or SE events per 100 patient years. Diagnosis of stroke=the nontraumatic focal neurological deficit lasting at least 24 hours, and includes ischemic stroke, hemorrhagic stroke, ischemic stroke with hemorrhagic conversion, stroke of uncertain type, and retinal ischemic event (embolism, infarction). Diagnosis of SE=clinical history consistent with an acute loss of blood flow to a peripheral artery (or arteries), supported by evidence of embolism from surgical specimens, autopsy, angiography, vascular imaging, or other objective testing.|"Intended Treatment Period started on the day of randomization and ended at the efficacy cut-off date (date on which it was expected that the target number of primary efficacy events [448] would have occurred; set to 30-Jan-2011, prior to unblinding)."|Intention to treat analysis, randomized participants. Participants who did not experience an efficacy endpoint event were censored at the earlier of their death date (when death is not part of the endpoint), last contact date (for subjects who withdrew consent to be followed up or were lost to follow-up) or the efficacy cut-off date (30-Jan-2011).||Number of events per 100 patient years|||Number
732799|NCT00412984|Primary|Number of Participants With First Event of Ischemic/Unspecified Stroke, Hemorrhagic Stroke, or Systemic Embolism (SE) During the Intended Treatment Period|All suspected efficacy events were adjudicated by the Central Events Committee (CEC). Diagnosis of stroke=the nontraumatic focal neurological deficit lasting at least 24 hours, and includes ischemic stroke, hemorrhagic stroke, ischemic stroke with hemorrhagic conversion, stroke of uncertain type, and retinal ischemic event (embolism, infarction). Diagnosis of SE=clinical history consistent with an acute loss of blood flow to a peripheral artery (or arteries), supported by evidence of embolism from surgical specimens, autopsy, angiography, vascular imaging, or other objective testing.|"Time to first event in Intended Treatment Period: started on day of randomization, ended at efficacy cut-off date (date target number of primary efficacy events [448] was expected to have occurred; set to 30-Jan-2011, prior to unblinding)."|Intention to treat analysis, randomized participants. Participants who did not experience an efficacy endpoint event were censored at the earlier of their death date (when death is not part of the endpoint), last contact date (for subjects who withdrew consent to be followed up or were lost to follow-up) or the efficacy cut-off date (30-Jan-2011).||participants|||Number
732800|NCT00413010|Secondary|Change in Hamilton Depression Rating Scale (HAM-D) Total Score|Change: score at each study week minus score at baseline. HAM-D, clinician-rated interview, measures presence of depressive symptoms in 17 areas (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, & weight loss). Total score ranges from 0 to 52; higher scores indicate more depression.|Weeks 1 through Week 8|Intent-to-Treat (ITT) population included all randomized subjects who had received at least 1 dose of the double-blind treatment, and had a baseline and post-baseline efficacy assessment.||score on scale||Standard Error|Least Squares Mean
732801|NCT00413010|Secondary|Clinical Global Impression of Severity (CGI-S) Score|CGI-S is a clinician-rated instrument measuring the severity of a subject’s symptoms on a 7-point categorical scale. Scores range from 1 (not at all ill) to 7 (among the most extremely ill patients). Higher score indicates that the subject is more ill.|Week 8|Intent-to-Treat (ITT) population included all randomized subjects who had received at least 1 dose of the double-blind treatment, and had a baseline and post-baseline efficacy assessment.||participants|||Number
732802|NCT00413010|Secondary|Number of Responders Using Clinical Global Impression of Improvement (CGI-I) Score|Responders = YES using CGI-I if score indicated much improved or very much improved at the last study week. CGI-I is a clinician-rated instrument that measures change in subject’s overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).|Week 1 through Week 8|Intent-to-Treat (ITT) population included all randomized subjects who had received at least 1 dose of the double-blind treatment, and had a baseline and post-baseline efficacy assessment.||participants|||Number
732803|NCT00413010|Secondary|Time to Onset of Sustained Hamilton Anxiety Rating Scale (HAM-A) Improvement|Time to sustained improvement was defined as time to 50% or greater reduction in HAM-A total score from Baseline, which was sustained for the remainder of the study. HAM-A is a clinician-rated interview measuring the presence of anxiety-related symptoms in 14 areas. Total score ranges from 0 to 56; a higher score indicates greater anxiety.|Week 8|Intent-to-Treat (ITT) population included all randomized subjects who had received at least 1 dose of the double-blind treatment, and had a baseline and post-baseline efficacy assessment. CI for placebo patients was not estimable.||days||95% Confidence Interval|Median
732804|NCT00413010|Secondary|Subjects in Remission Using Hamilton Anxiety Rating Scale (HAM-A) Total Score|Participant in remission defined as HAM-A total score of <= 7. HAM-A=clinician-rated interview measuring presence of anxiety-related symptoms in 14 areas including anxiety, tension, depressed mood, palpitations, breathing difficulties, sleep disturbances, & restlessness. Total score ranges 0 - 56; higher score indicates greater anxiety.|Week 1 through Week 8|Intent-to-Treat (ITT) population included all randomized subjects who had received at least 1 dose of the double-blind treatment, and had a baseline and post-baseline efficacy assessment.||participants|||Number
732805|NCT00413010|Secondary|Number of Responders Using Hamilton Anxiety Rating Scale (HAM-A)|Responders = YES if subjects achieved a >= 50% decrease in HAM-A total score from Baseline to respective study week. HAM-A is a clinician-rated interview measuring the presence of anxiety-related symptoms in 14 areas. Total score ranges from 0 to 56; higher score indicates greater anxiety.|Weeks 1 through Week 8|Intent-to-Treat (ITT) population included all randomized subjects who had received at least 1 dose of the double-blind treatment, and had a baseline and post-baseline efficacy assessment.||participants|||Number
732806|NCT00413010|Secondary|Change in HAM-A Total Score at Weekly Visits|Change: score at each study week minus score at baseline. HAM-A, a clinician-rated interview, measures presence of anxiety-related symptoms in 14 areas including anxiety, tension, depressed mood, palpitations, breathing difficulties, sleep disturbances, & restlessness. Total score ranges from 0 to 56; higher score indicates greater anxiety.|Baseline, Weeks 1 through Week 8|Intent-to-Treat (ITT) population included all randomized subjects who had received at least 1 dose of the double-blind treatment. All efficacy analyses included the ITT subjects who had a Baseline and a post-Baseline assessment of the respective efficacy endpoints.||score on scale||Standard Error|Least Squares Mean
732835|NCT00413153|Secondary|Fasting Glucose|6 month mean and standard deviation for fasting glucose.|6 months|Repeated measures analysis using all available data points for each participant||mg/dL||Standard Deviation|Mean
732808|NCT00413036|Secondary|Proportion of Participants Who Experienced Stable Disease or Better as Determined by Central Review|"Response assessed according to Cheson, Journal of Clinical Oncology, 1999. Full definitions, refer to Cheson article.
Complete Response(CR): Complete disappearance of all detectable disease and disease-related symptoms if present before therapy; normalization of lab abnormalities assignable to NHL. If bone marrow involved before treatment, must be cleared on repeat biopsy.
Complete Response Unconfirmed(CRu): CR, with one of the following: 1)residual lymph node mass >1.5 cm that has decreased by 75% in the sum of the product of the diameters(SPD). Individual nodes previously confluent decreased by more than 75% in the SPD compared with original mass; 2)indeterminate bone marrow.
Partial Response(PR): >50% decrease in 6 largest nodes or nodal masses. Nodes selected according to Cheson.
Stable Disease(SD): Less than PR, but not progressive disease."|Up to 1459 days|Tumor Control Rate or Proportion of Participants Who Experienced Stable Disease or Better (SD+PR+CRu+CR) was not analyzed. Overall Response Rate (PR+CRu+CR) is presented as the primary endpoint, and because it is a more widely accepted/used efficacy endpoint than tumor control rate, a decision was made not to analyze tumor control rate.|||||
732809|NCT00413036|Secondary|Progression-free Survival as Determined by Central Review|"Kaplan-Meier estimate of progression-free survival is defined as start of study drug therapy to the first observation of progressive disease or death due to any cause, whichever comes first.
Response assessed according to Cheson, Journal of Clinical Oncology, 1999. Full definition of progressive disease, refer to Cheson article.
Progressive Disease(PD): Appearance of new lesion during/end of therapy; >=50% increase from lowest measurement in SPD."|Up to 1459 days|Intent-to-treat population||Months||95% Confidence Interval|Median
732810|NCT00413036|Secondary|Time to Progression as Determined by Central Review|"Kaplan-Meier estimate of time-to-progression is calculated as time from the start of study drug therapy to the first observation of disease progression.
Response assessed according to Cheson, Journal of Clinical Oncology, 1999. Full definition of progressive disease, refer to Cheson article.
Progressive Disease(PD): Appearance of new lesion during/end of therapy; >=50% increase from lowest measurement in SPD."|Up to 1459 days|Intent-to-treat population||Months||95% Confidence Interval|Median
732811|NCT00413036|Secondary|Duration of Response as Determined by Central Review|"Kaplan-Meier estimates for the duration of response were calculated for responders and defined as the time from at least a partial response (PR) to progression of disease (PD) or death due to Non-Hodgkin's lymphoma.
For response assessment criteria (per Cheson, 1999) see the primary outcome measure in this results posting."|Up to 1459 days|Intent-to-treat population||Months||95% Confidence Interval|Median
732812|NCT00413036|Primary|Participants Categorized by Best Response as Determined by Central Review|"Response assessed according to Cheson, Journal of Clinical Oncology, 1999. Full definitions, refer to Cheson article.
Complete Response(CR): Complete disappearance of all detectable disease and disease-related symptoms if present before therapy; normalization of lab abnormalities assignable to NHL. If bone marrow involved before treatment, must be cleared on repeat biopsy.
Complete Response Unconfirmed(CRu): CR, with one of the following: 1)residual lymph node mass >1.5 cm that has decreased by 75% in the sum of the product of the diameters(SPD). Individual nodes previously confluent decreased by more than 75% in the SPD compared with original mass; 2)indeterminate bone marrow.
Partial Response(PR): >50% decrease in 6 largest nodes or nodal masses. Nodes selected according to Cheson.
Stable Disease(SD): Less than PR, but not progressive disease.
Progressive Disease(PD): Appearance of new lesion during/end of therapy; >=50% increase from lowest measurement in SPD."|Up to 1459 days|Intent-to-treat population||Participants|||Number
732813|NCT00413049|Secondary|Change in 24-hour Mean Ambulatory Diastolic and Systolic BP From Baseline at the End of the Study (Week 8)|Two 24 hour ambulatory blood pressure monitoring (ABPM) evaluations were performed, one at baseline prior to randomization and one at Week 8 (end of study), in a subset of the intent-to-treat population of patients. For each evaluation, the ABPM device was attached to the non-dominant arm of the patient. A correlation was made between the ABPM device readings and measurements taken with a mercury sphygmomanometer and stethoscope. Following the correlation procedure, BP was measured at study specified intervals. A negative change score indicates lowered BP.|Baseline to end of study (Week 8)|||mmHg||Standard Deviation|Mean
732814|NCT00413049|Secondary|Percentage of Patients Achieving Overall Control at the End of the Study (Week 8)|A patient achieved overall control if the msSBP/msDBP < 140/90 mmHg at the end of the study (Week 8). Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated.|Baseline to end of study (Week 8)|Intent-to-Treat (ITT): All randomized patients who had baseline and at least one post-baseline efficacy measurement, ie, any post-baseline measurement of primary or secondary efficacy variables. For patients who did not complete the Week 8 assessment, a last observation carried forward (LOCF) approach was used.||Percentage of patients|||Number
732815|NCT00413049|Secondary|Percentage of Patients Achieving Diastolic Control at the End of the Study (Week 8)|A patient achieved diastolic control if their msDBP < 90 mmHg at the end of the study (Week 8). Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated.|Baseline to end of study (Week 8)|Intent-to-Treat (ITT): All randomized patients who had baseline and at least one post-baseline efficacy measurement, ie, any post-baseline measurement of primary or secondary efficacy variables. For patients who did not complete the Week 8 assessment, a last observation carried forward (LOCF) approach was used.||Percentage of patients|||Number
732836|NCT00413153|Secondary|Insulin Sensitivity|6 month mean and standard deviation for insulin-stimulated glucose uptake (M) per unit insulin at 120 minutes as measured by euglycemic hyperinsulinemic clamp.|6 months|Repeated measures analysis using all available data points for each participant||umol/kg/min per uU/mL insulin||Standard Deviation|Mean
732872|NCT00413231|Secondary|Percentage of Participants That Experienced Aneurysm-related Mortality|Percentage of subjects that experienced aneurysm-related mortality within 12 months post treatment|Within 12 months post treatment|Subjects treated or intended to treat with the test device, excluding subjects exited before 12 months and implant failures||Percentage of participants||95% Confidence Interval|Number
732816|NCT00413049|Secondary|Percentage of Patients Achieving a Diastolic Response at the End of the Study (Week 8)|A patient achieved a diastolic response if their msDBP < 90 mmHg at Week 8 or they had a ≥ 10 mmHg decrease in msDBP compared to baseline at the end of the study (Week 8). Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated.|Baseline to end of study (Week 8)|Intent-to-Treat (ITT): All randomized patients who had baseline and at least one post-baseline efficacy measurement, ie, any post-baseline measurement of primary or secondary efficacy variables. For patients who did not complete the Week 8 assessment, a last observation carried forward (LOCF) approach was used.||Percentage of patients|||Number
732817|NCT00413049|Secondary|Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8)|Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated. A negative change score indicates lowered BP.|Baseline to end of study (Week 8)|Intent-to-Treat (ITT): All randomized patients who had baseline and at least one post-baseline efficacy measurement, ie, any post-baseline measurement of primary or secondary efficacy variables. For patients who did not complete the Week 8 assessment, a last observation carried forward (LOCF) approach was used.||mmHg||Standard Error|Least Squares Mean
732818|NCT00413049|Primary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8)|Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated. A negative change score indicates lowered BP.|Baseline to end of study (Week 8)|Intent-to-Treat (ITT): All randomized patients who had baseline and at least one post-baseline efficacy measurement, ie, any post-baseline measurement of primary or secondary efficacy variables. For patients who did not complete the Week 8 assessment, a last observation carried forward (LOCF) approach was used.||mmHg||Standard Error|Least Squares Mean
732819|NCT00413062|Secondary|Average Number of Withdrawal Bleeding/Spotting Days|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Withdrawal bleeding was defined as bleeding/spotting episode that started during or continued into the expected bleeding period. Expected bleeding period: DRSP-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle."|Every 28-day cycle for 13 cycles (one year total)|"ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.
n= number of participants who had withdrawal bleeding/spotting for the respective cycle."||days||Standard Deviation|Mean
732820|NCT00413062|Secondary|Average Number of Breakthrough Bleeding/Spotting Days|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding/spotting was defined as any episode that occurred during the expected non-bleeding period that was neither an early nor a continued withdrawal bleeding. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle."|Every 28-day cycle for 13 cycles (one year total)|"ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.
n= number of participants who had breakthrough bleeding/spotting for the respective cycle."||days||Standard Deviation|Mean
732821|NCT00413062|Secondary|Number of Participants With an Occurrence of Continued Withdrawal Bleeding|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Continued withdrawal bleeding was defined as any withdrawal bleeding that continued into the expected non-bleeding period of the next cycle.
Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle."|Every 28-day cycle for 12 cycles|The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.||participants|||Number
732822|NCT00413062|Secondary|Number of Participants With an Occurrence of Early Withdrawal Bleeding|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Early withdrawal bleeding was defined as any withdrawal bleeding that started before the current expected bleeding period.
Expected bleeding period: DRSP-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle."|Every 28-day cycle for 13 cycles (one year total)|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.
n= number of participants with evaluable cycles."||participants|||Number
732873|NCT00413231|Secondary|Percentage of Participants That Experienced One or More Major Adverse Events|Percentage of subjects that experienced one or more major adverse events within 30 days post treatment, regardless of relatedness to study device|Within 30 days post treatment|Subjects treated or intended to treat with the test device||Percentage of participants||95% Confidence Interval|Number
736589|NCT00443040|Secondary|Time to Tolerating Solid Food|Time to tolerating solid food (toleration is defined as the absence of nausea or vomiting) within 4 hours of ingesting a meal|4 hours of ingesting a meal||||||
732823|NCT00413062|Secondary|Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only)|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough spotting was defined as any spotting episode that occurred during the expected non-bleeding period that was neither part of an early nor continued withdrawal bleeding.
Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle."|Every 28-day cycle for 13 cycles (one year total)|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.
n= number of participants with evaluable cycles."||participants|||Number
732824|NCT00413062|Secondary|Number of Participants With an Occurrence of Breakthrough Bleeding|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding was defined as any bleeding episode that occurred during the expected non-bleeding period that was neither part of an early nor continued withdrawal bleeding.
Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle."|Every 28-day cycle for 13 cycles (one year total)|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.
n= number of participants with evaluable cycles."||participants|||Number
732825|NCT00413062|Secondary|Number of Participants With an Occurrence of Absence of Withdrawal Bleeding|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Absence of withdrawal bleeding was defined as no bleeding/spotting episode that began during or continued into the expected bleeding period. Expected bleeding period: DRSP-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle."|Every 28-day cycle for 13 cycles (one year total)|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.
n= number of participants with evaluable cycles."||participants|||Number
732826|NCT00413062|Primary|Number of In-treatment Pregnancies (With +14 Day Window) Per 100 Woman Years of Exposure (Pearl Index)|In-treatment pregnancies were pregnancies with an estimated date of conception from the day of first intake of trial medication up to and including the day of last (active or placebo) intake of trial medication extended with a period of 14 days. Each 13 cycles (28 days per cycle) of exposure constitutes a woman year. The Pearl Index was obtained by dividing the number of in-treatment pregnancies that occurred by the time (in 100 women years) that the women were under risk of becoming pregnant.|1 year (13 cycles)|"The restricted ITT set included all participants treated except for 27 nonpregnant participants whose exposure was excluded due to limited credibility of diary data, & also excluded nonpregnant participants without >= 1 cycle expected to be at risk for pregnancy (with recorded use of condoms or w/o sexual intercourse, based on e-diary data)."||Pregnancies per 100 woman years|Participants|95% Confidence Interval|Number
732827|NCT00413062|Secondary|Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding/spotting was defined as any episode that occurred during the expected non-bleeding period that was neither an early nor a continued withdrawal bleeding. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle."|Every 28-day cycle for 13 cycles (one year total)|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.
n= number of participants with evaluable cycles."||participants|||Number
732828|NCT00413062|Primary|Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index)|In-treatment pregnancies were pregnancies with an estimated date of conception from the day of first intake of trial medication up to and including the day of last (active or placebo) intake of trial medication extended with a maximum of two days. Each 13 cycles (28 days per cycle) of exposure constitutes a woman year. The Pearl Index was obtained by dividing the number of in-treatment pregnancies that occurred by the time (in 100 women years) that the women were under risk of becoming pregnant.|1 year (13 cycles)|"The restricted ITT set included all participants treated except for 27 nonpregnant participants whose exposure was excluded due to limited credibility of diary data, & also excluded nonpregnant participants without >= 1 cycle expected to be at risk for pregnancy (with recorded use of condoms or w/o sexual intercourse, based on e-diary data)."||Pregnancies per 100 woman years|Participants|95% Confidence Interval|Number
732829|NCT00413153|Secondary|Total Bilirubin|6 month mean and standard deviation for total bilirubin.|6 months|Repeated measures analysis using all available data points for each participant||mg/dL||Standard Deviation|Mean
732830|NCT00413153|Secondary|Liver Enzymes -- Alanine Aminotransferase (ALT)|6 month mean and standard deviation for ALT.|6 months|Repeated measures analysis using all available data points for each participant||U/L||Standard Deviation|Mean
732831|NCT00413153|Secondary|Liver Enzymes -- Aspartate Aminotransferase (AST)|6 month mean and standard deviation for AST.|6 months|Repeated measures analysis using all available data points for each participant||U/L||Standard Deviation|Mean
732832|NCT00413153|Secondary|Immune Parameters -- CD4 Count|6 month mean and standard deviation for CD4+ count.|6 months|Repeated measures analysis using all available data points for each participant||cells/microL||Standard Deviation|Mean
732838|NCT00413192|Secondary|Summary of Adverse Events (AEs)|Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. TEAEs are defined as an adverse event (AE) that emerged during treatment, having been absent at baseline or: reemerged during treatment, having been present at pretreatment (baseline) but stopped before treatment, or worsened in severity during treatment relative to the pretreatment state, when the AE was continuous. All AEs and SAEs were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. A participant was counted only once within a System Organ Class (SOC) and preferred term (PT), even if the participant experienced more than one TEAE with a specific SOC and PT. Participants were summarized by treatment group according to the worst CTCAE grade assigned for each PT. Treatment-related TEAEs included TEAEs that were considered by the investigator to be possibly or probably related to study drug or TEAEs with a missing relationship.|Day 1 of study treatment until progressive disease, or up to cut-off date of 28 Jun 2012, up to approximately 5.5 years|Safety analysis set included all participants who received at least one dose of study drug, regardless of their eligibility to enter the study.||Percentage of participants|||Number
732839|NCT00413192|Secondary|Overall Survival (OS)|Participants still alive at the end of the study had their time to event censored at the day last known to be alive. Participants lost to follow-up were also censored at the date last known to be alive. 95% CIs for the percentage of participants still alive at the end of the study were presented as described for the primary endpoint, PFS at Week 12.|Date of first dose of study drug to date of death from any cause, or up to cut-off date of 28 Jun 2012, up to approximately 5.5 years|EES||Days||95% Confidence Interval|Median
732840|NCT00413192|Secondary|Duration of Response|Duration of response could be calculated only if a participant achieved a BOR of CR or PR, as defined previously. For consistency with the formula used by the European Organization for Research and Treatment of Cancer (EORTC), the duration was derived as “day of event minus day of first documented CR or PR” (one was not added to the calculation). Participants who were alive without documented progression had their duration of response censored at the day of last follow-up for progression. Participants who never achieved CR or PR were not included in the Kaplan-Meier survival estimates for the duration of response by strata. No adjustment was made for participants who started further anticancer therapy prior to disease progression.|Date of first documented CR or PR until the date of first document disease progression (or death), or up to data cutoff 28 Jun 2012, up to approximately 5.5 years|EES||Days||95% Confidence Interval|Median
732841|NCT00413192|Secondary|Time to Onset of Response|Time to onset of response could be calculated only if a participant achieved an objective response (BOR of CR or PR as defined previously). Participants who never achieved CR or PR were not included in the Kaplan-Meier survival estimates for the time to onset of response by strata. Given the small number of participants with these responses and the large variation in time to onset of response between participants, no comparison could be made among the strata.|Date of first dose of study drug to date of first documented CR or PR, or until data cutoff date 28 Jun 2012, up to approximately 5.5 years|EES||Days||95% Confidence Interval|Median
732842|NCT00413192|Secondary|Clinical Response Benefit (CRB)|CRB was defined as the percentage of participants with a BOR of CR or PR or SD as defined by RECIST, described previously. BOR was derived using the same hierarchy as used when determining the status at Week 12. No adjustments were made for participants who started further anticancer therapy prior to disease progression. 95% CIs were calculated using the exact method of binomial distribution. CRB = CR + PR + SD|Date of first dose of study drug to documentation of CR, PR, or SD, or until data cutoff date 28 Jun 2012, up to approximately 5.5 years|EES||Percentage of participants||95% Confidence Interval|Number
732843|NCT00413192|Secondary|Objective Response Rate (ORR)|ORR was defined as the percentage of participants in the analysis set who had a BOR of CR or PR based on RECIST v. 1.0 for target lesions. Tumors were assessed using x-rays, magnetic resonance imaging (MRI), or computed tomography (CT) scans, or both, as appropriate. ORR was documented and confirmed by two measurements taken at least 4 weeks apart. CR was defined as the disappearance of all target lesions. PR defined as ≥ 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD. Best overall response was derived using the same hierarchy as used when determining the PFS status at Week 12. No adjustments were made for participants who started further anticancer therapy prior to disease progression. 95% CIs were calculated using the exact method of binomial distribution. ORR = CR + PR|Date of first dose of study drug until documentation of CR or PR, or up to data cutoff 28 Jun 2012, up to approximately 5.5 years|EES||Percentage of participants||95% Confidence Interval|Number
732844|NCT00413192|Secondary|Overall Progression Free Survival|Overall PFS was determined from any evidence that the participant had progressed, along with whether or not the participant was still alive at the end of the study. Tumors were evaluated every 6 weeks during treatment, and at least 4 weeks after the first observation of a complete or partial response. After discontinuation of study drug, participants without PD were re-evaluated every 12 weeks, unless a new anticancer therapy was started. Participants were considered as having progressed if they were classed as PD at Week 12, or had a best overall response (BOR) of PD, or had a date of progression, if they discontinued due to PD, died due to PD, or if the PI had recorded a date of progression. A participant was determined progression free if they were alive without PD at the time of study cut-off. The number and percentage of successes were summarized by stratum and overall, together with 95% 2-sided CIs for the percentage of successes.|First dose of study drug to the date of disease progression or date of death, whichever occurs first, or date of study cut-off 28 Jun 2012, up to 5.5 years|EES||Days||95% Confidence Interval|Median
732845|NCT00413192|Primary|Progression Free Survival (PFS) at 12 Weeks|PFS was determined from the Week 12 visit tumor scan and the participant’s date of death. Progression was defined as complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), early death from any cause, or not assessable according to Response Evaluation Criteria In Solid Tumors (RECIST). CR defined as the loss of all target lesions. PR defined as ≥ 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD. PD defined as ≥ 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since treatment started or the appearance of new lesions. SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD since treatment started. The number and percentage of successes were summarized by stratum and overall, together with 95% 2-sided confidence intervals (CIs) for the percentage of successes.|Week 12|Efficacy evaluable set (EES) consisted of all registered, eligible subjects who had received at least one dose of study drug.||Percentage of participants||95% Confidence Interval|Number
732846|NCT00413218|Secondary|Time to First Confirmed Negative Culture|The first confirmed negative blood culture was defined as the first negative blood culture on or after first dose followed by a second negative blood culture at least 24 hours apart without any positive blood cultures in between. A participant without a confirmed negative blood culture was censored on the participant’s last visit day. This endpoint was analyzed for mITT participants with candidemia only using the Kaplan-Meier method. Only participants with at least one positive blood culture on or prior to first dose and the culture not resolved prior to first dose were included in this analysis|Day 1 up to FU1 (2 weeks after EOT (Day 56))|The mITT was the primary efficacy population and it consisted of ITT participants who had documented invasive candidiasis or candidemia at baseline based on the assessment of the independent blinded DRC.||Days||95% Confidence Interval|Median
732847|NCT00413218|Secondary|All-Cause Mortality (ACM) at Day 14 and Day 56|All-cause mortality is represented as the percentage of participants who died on or before the analysis day. Participants who were lost to follow-up (i.e., unknown survival status) before the analysis day were counted as death. All-cause mortality was examined on Day 14 and Day 56.|Day 14 and Day 56|The mITT was the primary efficacy population and it consisted of ITT participants who had documented invasive candidiasis or candidemia at baseline based on the assessment of the independent blinded DRC.||Percentage of Participants|||Number
732848|NCT00413218|Secondary|Percentage of Participants With Clinical Response of Success at Day 7 and EOT as Determined by The Investigator|Investigators defined clinical response as success if participants exhibited complete or partial clinical response after evaluation of clinical signs and symptoms.|Day 7 and EOT (Day 56)|The mITT was the primary efficacy population and it consisted of ITT participants who had documented invasive candidiasis or candidemia at baseline based on the assessment of the independent blinded DRC. The isavuconazole and caspofungin group included participants who switched to oral isavuconazol and voriconazole||Percentage of Participants|||Number
732849|NCT00413218|Secondary|Percentage of Participants With Mycological Response of Success at Day 7 and EOT as Determined by The Investigator|Success was defined as mycological response (eradication or presumed eradication).|Day 7 and EOT (Day 56)|The mITT was the primary efficacy population and it consisted of ITT participants who had documented invasive candidiasis or candidemia at baseline based on the assessment of the independent blinded DRC. The isavuconazole and caspofungin group included participants who switched to oral isavuconazol and voriconazole.||Percentage of Participants|||Number
732850|NCT00413218|Secondary|Percentage of Participants With Mycological Response of Success at EOIV, EOT, FU1 and FU2 as Determined by the Data Review Committee (DRC)|A data review committee (DRC) was established from independent experts in the field of fungal infections to determine diagnosis and outcomes independently of the investigators and sponsor. Success was defined as mycological response (Eradication or Presumed Eradication).|EOIV (Days 11-56), EOT (Day 56), FU1 (2 weeks after end of treatment) and FU2 (6 weeks after end of treatment)|The mITT was the primary efficacy population and it consisted of ITT participants who had documented invasive candidiasis or candidemia at baseline based on the assessment of the independent blinded DRC. The isavuconazole and caspofungin group included participants who switched to oral isavuconazol and voriconazole.||Percentage of Participants|||Number
732851|NCT00413218|Secondary|Percentage of Participants With Clinical Response of Success at EOIV, EOT, FU1 and FU2 as Determined by the Data Review Committee (DRC)|A data review committee (DRC) was established from independent experts in the field of fungal infections to determine diagnosis and outcomes independently of the investigators and sponsor. Success was defined as clinical response (complete or partial).|EOIV (Days 11-56), EOT (Day 56), FU1 (2 weeks after end of treatment) and FU2 (6 weeks after end of treatment)|The mITT was the primary efficacy population and it consisted of ITT participants who had documented invasive candidiasis or candidemia at baseline based on the assessment of the independent blinded DRC. The isavuconazole and caspofungin group included participants who switched to oral isavuconazol and voriconazole.||Percentage of Participants|||Number
732852|NCT00413218|Secondary|Percentage of Participants With Overall Response of Success at EOT and Follow Up Visit 2 (FU2) as Determined by the DRC Based on the Assessments of Clinical and Mycological Responses as Well as Alternative Systemic AFT Use at EOT and FU2|A data review committee (DRC) was established from independent experts in the field of fungal infections to determine diagnosis and outcomes independently of the investigators and sponsor. Success was defined as clinical response (complete or partial) and mycological response (eradication or presumed eradication), without the use of alternative systemic antifungal therapy AFT within 48 hours after the last dose of IV study medication (for EOT analysis) or for continued treatment of the primary infection, or for recurrent or emergent infection by FU2, with no recurrent or emergent infection by FU2 (for FU2 analysis).|EOT (Day 56) and FU2 (6 weeks after end of treatment)|The mITT was the primary efficacy population and it consisted of ITT participants who had documented invasive candidiasis or candidemia at baseline based on the assessment of the independent blinded DRC. The isavuconazole and caspofungin group included participants who switched to oral isavuconazol and voriconazole.||Percentage of Participants|||Number
732853|NCT00413218|Secondary|Percentage of Participants With Overall Response of Success at Follow Up Visit 1 (FU1-2 Weeks After End of Treatment (EOT)) as Determined by the DRC Based on the Assessments of Clinical, Mycological Responses and Antifungal Therapy (AFT)|A data review committee (DRC) was established from independent experts in the field of fungal infections to determine diagnosis and outcomes independently of the investigators and sponsor. Success was defined as clinical response (complete or partial) and mycological response (eradication or presumed eradication), without the use of alternative systemic AFT within 48 hours after the last dose of IV study medication.|End of Treatment (EOT) (Day 56) and FU1 (2 weeks after end of treatment)|The mITT was the primary efficacy population and it consisted of ITT participants who had documented invasive candidiasis or candidemia at baseline based on the assessment of the independent blinded DRC. The isavuconazole and caspofungin group included participants who switched to oral isavuconazol and voriconazole.||Percentage of Participants|||Number
732874|NCT00413231|Secondary|Percentage of Participants That Experienced Secondary Procedures Due to Endoleak After Discharge|Percentage of subjects that experienced secondary procedures due to endoleak after discharge within 30 days post treatment|Within 30 days post treatment|Subjects treated or intended to treat with the test device||Percentage of participants||95% Confidence Interval|Number
732875|NCT00413231|Secondary|Percentage of Participants That Experienced Paraparesis|Percentage of subjects that experienced paraparesis within 30 days post treatment|Within 30 days post treatment|Subjects treated or intended to treat with the test device||Percentage of participants||95% Confidence Interval|Number
732854|NCT00413218|Primary|Percentage of Participants With Overall Response of Success at the End of Intravenous Therapy (EOIV) as Determined by the Data Review Committee (DRC) Based on the Assessments of Clinical and Mycological Responses as Well as Alternative Systemic AFT Use|A Data Review Committee (DRC) was established from independent experts in the field of fungal infections to determine diagnosis and outcomes independently of the investigators and sponsor. Success was defined as clinical response (complete or partial) and mycological response (eradication or presumed eradication) without the use of alternative systemic antifungal therapy (AFT) within 48 hours after the last dose of IV study medication.|End of Intravenous Treatment (EOIV) (Days 11-56)|The ITT population consisted of all randomized participants who received at least one dose of study drug. The mITT population consisted of ITT participants who had documented invasive candidiasis or candidemia at baseline based on the assessment of the independent blinded DRC. Reporting arms included participants who switched to oral ISA and CAS.||Percentage of Participants|||Number
732855|NCT00413231|Secondary|Percentage of Participants That Experienced Loss of Stent Graft Patency|Percentage of subjects that experienced loss of stent graft patency within five years post implant|0 through 1825 days post treatment|Subjects treated or intended to treat with the test device||Percentage of participants|||Number
732856|NCT00413231|Secondary|Percentage of Participants That Experienced Stent Graft Migrations (Site Reported)|Percentage of subjects that experienced stent graft migrations within five years post implant, as reported by the clinical sites|0 through 1825 days post treatment|Subjects treated or intended to treat with the test device||Percentage of participants|||Number
732857|NCT00413231|Secondary|Percentage of Participants That Experienced Secondary Endovascular Procedures|Percentage of subjects that experienced secondary endovascular procedures within five years post implant|0 through 1825 days post treatment|Subjects treated or intended to treat with the test device||Percentage of participants|||Number
732858|NCT00413231|Secondary|Percentage of Participants That Experienced Type IV Endoleaks|Percentage of subjects that experienced type IV endoleaks within five years post implant|0 through 1825 days post treatment|Subjects treated or intended to treat with the test device||Percentage of participants|||Number
732859|NCT00413231|Secondary|Percentage of Participants That Experienced Type III Endoleaks|Percentage of subjects that experienced type III endoleaks within five years post implant|0 through 1825 days post treatment|Subjects treated or intended to treat with the test device||Percentage of participants|||Number
732860|NCT00413231|Secondary|Percentage of Participants That Experienced Type I Endoleaks|Percentage of subjects that experienced type I endoleaks within five years post implant|0 through 1825 days post treatment|Subjects treated or intended to treat with the test device||Percentage of participants|||Number
732861|NCT00413231|Secondary|Percentage of Participants That Experienced Conversions to Open Surgical Repair|Percentage of subjects that experienced conversions to open surgical repair within five years post implant|0 through 1825 days post treatment|Subjects treated or intended to treat with the test device||Percentage of participants|||Number
732862|NCT00413231|Secondary|Percentage of Participants That Experienced Aneurysm Ruptures|Percentage of subjects that experienced aneurysm ruptures within five years post implant|0 through 1825 days post treatment|Subjects treated or intended to treat with the test device||Percentage of participants|||Number
732863|NCT00413231|Secondary|Percentage of Participants That Experienced Aneurysm-related Mortality|Percentage of subjects that experienced aneurysm-related within five years post implant|0 through 1825 days post treatment|Subjects treated or intended to treat with the test device||Percentage of participants|||Number
732864|NCT00413231|Secondary|Percentage of Participants That Died (All-cause Mortality)|Percentage of subjects that died (all-cause mortality) five years post implant, regardless whether or not the cause of death was related to procedure, device, or condition treated|0 through 1825 days post treatment|Subjects treated or intended to treat with the test device||Percentage of participants|||Number
732865|NCT00413231|Secondary|Percentage of Participants That Experienced One or More Major Adverse Events|Percentage of subjects that experienced one or more Major Adverse Events within 12 months post treatment|Within 12 months post treatment|Subjects treated or intended to treat with the test device, excluded subjects that exited before 12 months||Percentage of participants||95% Confidence Interval|Number
732866|NCT00413231|Secondary|Percentage of Participants That Experience Loss of Stent Graft Patency|Percentage of subjects that experience loss of stent graft patency within 12 months post treatment|Within 12 months post treatment|Subjects treated or intended to treat with the test device, excluding subjects that did not have proper imaging||Percentage of participants||95% Confidence Interval|Number
732867|NCT00413231|Secondary|Percentage of Participants That Experienced Stent Graft Migration|Percentage of subjects that experienced stent graft migration within 12 months post treatment, as reported by the CEC. Of note, all migrations resulted from anatomical accommodation of the stent graft. All migrations were at the distal end of the stent graft, moving proximally. No endoleaks were associated to these migrations.|Within 12 months post treatment|Subjects treated or intended to treat with the test device, excluding subjects that did not have proper imaging||Percentage of participants||95% Confidence Interval|Number
732868|NCT00413231|Secondary|Percentage of Participants That Experienced Secondary Endovascular Procedures Due to Endoleak|Percentage of subjects that experienced secondary endovascular procedures due to endoleak between 30 days and 12 months|Between 30 days and 12 months|Subjects treated or intended to treat with the test device excluding censored subjects (those with no data within the time frame)||Percentage of participants||95% Confidence Interval|Number
732869|NCT00413231|Secondary|Percentage of Participants That Experienced Endoleak(s)|Percentage of subjects that experienced endoleak(s) of any type at 12 months|At 12 months|Subjects treated or intended to treat with the test device excluding subjects that did not have proper imaging to identify endoleaks||Percentage of participants||95% Confidence Interval|Number
732870|NCT00413231|Secondary|Percentage of Participants That Experienced Conversion to Open Surgical Repair|Percentage of subjects that experienced conversion to open surgical repair within 12 months post treatment|Within 12 months post treatment|Subjects treated or intended to treat with the test device excluding subjects exited before 12 months||Percentage of participants||95% Confidence Interval|Number
732871|NCT00413231|Secondary|Percentage of Participants That Experience Aneurysm Rupture|Percentage of subjects that experience aneurysm rupture within 12 months post treatment|Within 12 months post treatment|Subjects treated or intended to treat with the test device excluding subjects that exited before 12 months||Percentage of participants||95% Confidence Interval|Number
732876|NCT00413231|Primary|Percentage of Participants Who Died (Primary Safety Endpoint: All-Cause Mortality) > >|"The percentage of participants who died within 12-months of the initial procedure, whether or not the cause of death was related to the study device, procedure, or condition treated.
>
> Note: All-cause mortality endpoint is not directly related to successful aneurysm treatment, which pertains to the absence of aneurysm growth and secondary procedure due to Type I and III endoleaks."|Within 12-months post treatment|Subjects treated or intended to treat with the test device||Percentage of Participants||95% Confidence Interval|Number
732877|NCT00413231|Primary|Percentage of Participants With Successful Aneurysm Treatment (Primary Effectiveness Endpoint)|"Percentage of subjects with absence of both: a) aneurysm growth of more than 5 mm at the 12-month visit relative to the 1-month visit; and b) secondary procedure due to type I or III endoleak performed or recommended at or before the 12-month visit. Success means a subject experienced neither a nor b.
Type I: endoleak in continuity with the proximal anchoring site(proximal endoleak) or the distal anchoring site(distal endoleak)of the device.
Type III: endoleak is present in the mid-graft region due to defect of fabric or between the segments of the modular graft (junctional endoleak)."|At 12-month post procedure|Subjects treated or intended to treat with the test device||Percentage of Participants||95% Confidence Interval|Number
732878|NCT00413231|Secondary|Percentage of Participants That Experienced Paraplegia|Percentage of subjects that experienced paraplegia within 30 days post treatment|Within 30 days post treatment|Subjects treated or intended to treat with the test device||Percentage of participants||95% Confidence Interval|Number
732879|NCT00413231|Secondary|Percentage of Participants That Experienced Perioperative Mortality|Percentage of subjects that experienced perioperative mortality. Perioperative morality is defined as all-cause mortality within 30 days after index procedure.|Within 30 days post treatment|Subjects treated or intended to treat with the test device||Percentage of participants||95% Confidence Interval|Number
732880|NCT00413231|Secondary|Percentage of Subjects That Experienced Successful Deployment and Delivery of the Stent Graft at Implant|Percentage of subjects that experienced successful deployment and delivery of the stent graft at implant. Successful deployment and delivery of the stent graft is used to measure effectiveness.|At implant|Subjects treated or intended to treat with the test device||Percentage of participants||95% Confidence Interval|Number
732881|NCT00413231|Primary|Percentage of Participants That Did NOT Experience Aneurysm-Related Mortality (Post-market Primary Endpoint)|Evaluation of the ARM-free rate in subjects implanted with the Valiant Thoracic Stent Graft five years post-implantation by comparing it to a pre-defined performance goal (PG) based on an analysis of ARM-free rates from TEVAR data and on results from the VALOR (Talent Thoracic Endoluminal Stent Graft, IDE G980116) clinical study.|0 through 1825 days post treatment|Subjects treated or intended to treat with the test device||Percentage of participants||90% Confidence Interval|Number
732882|NCT00413244|Secondary|IIEF-V: Over-all Satisfaction|Questions 13,14 of the IIEF relates to specifically to overall satisfaction scale from 0 - 10 (very dissatisfied to very satisfied)|At baseline, 1 month, 3 months, and 6 months|||units on a scale||Standard Deviation|Mean
732883|NCT00413244|Secondary|IIEF-IV: Intercourse Satisfaction|Questions 6,7, 8 of the IIEF relates to intercourse satisfaction scale 0 - 15 (from very dissatisfied to very satisfied)|At baseline, 1 month, 3 months, and 6 months|||units on a scale||Standard Deviation|Mean
732884|NCT00413244|Secondary|IIEF -III: Sexual Desire|Questions 11-12 of the IIEF relates to sexual desire scale 0-10 (from very low to very high)|At baseline, 1 month, 3 months, and 6 months|||units on a scale||Standard Deviation|Mean
732885|NCT00413244|Secondary|IIEF-II Orgasmic Function|Questions 9-10 of the IIEF relates to orgasmic function scale 0 - 10 (from no impairment to severe impairment)|At baseline, 1 month, 3 months, and 6 months|||units on a scale||Standard Deviation|Mean
732886|NCT00413244|Secondary|International Index of Erectile Function (IIEF)|Questions 1-5 15 of the IIEF relates to erectile function scale 0 - 30 (severe erectile dysfunction to no erectile dysfunction).|At baseline, 1 month, 3 months, and 6 months|||units on a scale||Standard Deviation|Mean
732887|NCT00413244|Secondary|Aging Male Symptoms (AMS)|The scale assesses symptoms of aging and their impact on HRQoL in males, and increases with increasing severity (1 to 5) of subjectively perceived complaints in 17 items. Scale ranges from 17-85 (no symptoms to extremely severe symptoms.)|At baseline, 1 month, 3 months, and 6 months|||units on a scale||Standard Deviation|Mean
732888|NCT00413244|Secondary|Metabolic Equivalents of Task (METS)|The Metabolic Equivalent of Task (MET), or simply metabolic equivalent, is a physiological measure expressing the energy cost of physical activities and is defined as the ratio of metabolic rate (and therefore the rate of energy consumption) during a specific physical activity to a reference metabolic rate, set by convention to 3.5 ml O2·kg−1·min−1 or equivalently|6 months|Subjects analyzed were only those subjects with ST depression at baseline||METS units||Standard Deviation|Mean
732889|NCT00413244|Secondary|International Prostate Symptom Score (IPSS)|"IPSS has 7 questions related to symptoms, each item scored 1-5. Total score can range from 0 to 35 (asymptomatic to very symptomatic). The 8th question refers to the patient's perceived quality of life ranged from 0 to 6 (delighted to terrible.) Data not collected."|6 months||||||
732890|NCT00413244|Secondary|Reactive Hyperemia Index|The Reactive Hyperemia Index measures the endothelial function and predicts future coronary events. In general RHI values below 2 are categorized as endothelial dysfunction and have a greater plaque burden, whereas higher RHI values are considered normal or improved endothelial function. PAT is the technique to non-invasively assess endothelial function. It comprises finger probes to evaluate digital volume changes.|6 months|Subjects analyzed were only those subjects with ST depression at baseline||mls||Standard Deviation|Mean
732891|NCT00413244|Secondary|Seattle Angina Questionnaire (SAQ)|"A cardiac disease-related quality-of-life measure. The SAQ is a self-report instrument with 19 items that, yields five subscale scores: physical limitation, angina stability, angina frequency, treatment satisfaction, and disease perception. The possible range of scores for each of the five subscales is 0 to 100, with higher scores indicating better quality of life. A change of 10 points in any of the subscales is considered to be clinically important.
Data not collected."|up to 6 months||||||
732892|NCT00413244|Primary|Cardiac Stress Testing: Exercise Capacity|Exercise capacity was measured using exercise time.|At 1 month, 3 months, and 6 months|Subjects analyzed were only those subjects with ST depression at baseline||seconds||Standard Deviation|Mean
732893|NCT00413244|Primary|Cardiac Stress Test: Time to ST Depression|Treadmill exercise testing performed according to the Bruce protocol (MAX-1 Marquette advanced exercise system, software version 002E). The system analyzed the signal averaged ECG and produces a graphical display of the level of the ST segment 80 ms after the J point against time. Time to 1 mm ST depression was measured from computer derived analysis, effectively eliminating observer bias.|at 6 months|Subjects analyzed were only those subjects with ST depression at baseline||seconds||Standard Deviation|Mean
732894|NCT00413283|Secondary|Gemcitabine Dose Reduction on Day 8 of the First Chemotherapy Cycle|Number of participants who required a gemcitabine dose reduction on Day 8 of the first on study chemotherapy cycle.|8 days|Efficacy Analysis Set, composed of all randomized participants except those who were replaced.||Participants|||Number
732895|NCT00413283|Secondary|Platelet Count on Day 22|Platelet count on Day 22 of the first on study chemotherapy treatment cycle (planned Day 1 of next cycle) by treatment group|Day 22|Efficacy Analysis Set, composed of all randomized participants except those who were replaced||10^9/L||Standard Deviation|Mean
732896|NCT00413283|Secondary|Number of Participants With Platelet Transfusions|Number of participants who were administered platelet transfusions during first on study treatment cycle.|3 weeks|Efficacy Analysis Set, composed of all randomized participants except those who were replaced.||Participants|||Number
732897|NCT00413283|Secondary|Number of Participants Experiencing Grade 3 or 4 Thrombocytopenia During the First Treatment Cycle.|The number of participants in each treatment group with grade 3 or 4 thrombocytopenia during the first on study treatment cycle. Per the Common Terminology Criteria for Adverse Events (CTCAE) v3.0, participants with a platelet count < 50 x 10^9/L, but ≥ 25 x 10^9/L are considered to have Grade 3 thrombocytopenia and participants with a platelet count < 25 x 10^9/L are considered to have Grade 4 thrombocytopenia. Additionally, participants with a platelet transfusion during the first on-study treatment cycle were classified as having Grade 3/4 thrombocytopenia.|3 weeks|Efficacy Analysis Set, composed of all randomized participants except those who were replaced.||Participants|||Number
732898|NCT00413283|Secondary|Duration of Grade 3 or 4 Thrombocytopenia|The duration of grade 3 or 4 thrombocytopenia (defined as platelet count <50 x 10^9/L) experienced during the first on study chemotherapy cycle by treatment group.|3 weeks|Efficacy Analysis Set, composed of all randomized participants except those who were replaced (participants who discontinued prior to the completion of at least 1 romiplostim treatment cycle for non-platelet-related reasons).||days||Standard Deviation|Mean
732899|NCT00413283|Primary|Number of Participants With Adverse Events|This summary includes all treatment-emergent adverse events recorded from the start of investigational product on this study, or any worsening of adverse events initially experienced before initiation of this study.|4 months|Safety Analysis Set, composed of all randomized participants who received at least one dose of study medication.||Participants|||Number
732900|NCT00413335|Primary|Mean Percent Change From Baseline in Hepatic Fat Fraction (HFF)|It refers to the percent changes of hepatic fat content.|4 months|||percentage of change from baseline||Standard Deviation|Mean
732901|NCT00413335|Secondary|Mean Percent Change From Baseline in Adiponectin|This refers to the changes of adiponectin levels.|4 months|||percentage of change from baseline||Standard Deviation|Mean
732902|NCT00413335|Primary|Percentage of Subjects Who Converted Impaired Glucose Tolerance (IGT) to Normal Glucose Tolerance (NGT)|This refers to the number of subjects that converted from IGT to NGT. NGT is defined as fasting glucose lower than 100 mg/dl and 2 hours glucose lower than 140 mg/dl. IGT is defined as 2 hours glucose higher than 140 mg/dl.|4 months|||percentage of participants|||Number
732903|NCT00413335|Primary|Mean Percent Change in Visceral-to-subcutaneous Abdominal Fat|This describes the percent changes of the ratio between visceral and subcutaneous abdominal fat.|4 months|||percentage of change from baseline||Standard Deviation|Mean
732904|NCT00413335|Primary|Mean Percent Change From Baseline in Whole-body Insulin Sensitivity|This describes the percent changes in insulin sensitivity. Insulin sensitivity was expressed as whole body insulin sensitivity index (WBISI) which is based on the values of insulin (microunits per milliliter) and glucose (milligrams per deciliter) obtained from the OGTT and the corresponding fasting values.The formula is: WBISI=10.000/square root of (fasting glucose x fasting insulin)x(mean glucose x mean insulin).|4 months|||percentage of change from baseline||Standard Deviation|Mean
732905|NCT00413374|Primary|Death||30 Days||||||
732906|NCT00413374|Primary|Recurrent VTE|Major clotting complication (recurrent VTE) as defined as recurrent acute pulmonary embolism confirmed on chest CT or recurrent deep vein thrombosis in the contralateral extremity confirmed with venous ultrasound or CT scan while on once daily enoxaparin therapy.|30 Days|||participants|||Number
732907|NCT00413374|Primary|Major Bleeding Complication|Major bleeding complication as defined as spinal, retroperitoneal, or intracranial bleeding; drop in hemoglobin ≥2g/dl or transfusion ≥2U or surgical or medical intervention, death related to bleeding.|30 Days|||participants|||Number
732908|NCT00413400|Secondary|Adipocyte Messenger Ribonucleic Acid (mRNA) Levels of Adipocytokines Including Tumor Necrosis Factor (TNF) -Alpha|fold-change in subcutaneous adipose tissue expression of TNF-alpha (mRNA) after 6 months|6 months|||fold-change||Standard Error|Mean
732909|NCT00413400|Secondary|Lipid Levels|total cholesterol (mg/dL) at 6 months|6 months|||mg/dL||Standard Error|Mean
732910|NCT00413400|Secondary|Other Adipocytokines|circulating resistin at 6 months|6 months|||ng/mL||Standard Error|Mean
732911|NCT00413400|Secondary|Tumor Necrosis Factor (TNF) Receptor|Circulating concentrations of Tumor necrosis factor receptor 2 (TNFR2) at 6 months|6 months|||pg/mL||Standard Error|Mean
732912|NCT00413400|Secondary|Body Composition|6 month visceral adipose tissue (cm^2) - cross-sectional area of the visceral adipose tissue at the level of the 4th lumbar vertebrae was measured using single-slice abdominal computed tomography (CT) scan|6 months|||cm^2||Standard Error|Mean
732913|NCT00413400|Secondary|Cardiac Echo Ejection Fraction (EF)|change in EF (6mo - baseline). Please note that the value given is the absolute change in EF (which has units of percent), not the percent change in the variable.|Baseline to 6 months|||percent||Standard Error|Mean
732914|NCT00413400|Secondary|White Blood Cell (WBC) Count|Change in WBC during study (WBC at six months minus WBC at baseline)|Baseline to 6 months|||th/cumm||Standard Error|Mean
732990|NCT00406848|Secondary|Change From Baseline in Pulse Rate||baseline (Week 1), Week 13, Week 25|All randomized patients with a baseline and at least one non-missing post-baseline value.||beats per minute (bpm)||Standard Error|Least Squares Mean
732915|NCT00413400|Secondary|Endothelial Function|Reactive Hyperemia Index (RHI) using peripheral artery tonometry (using Endo-PAT 2000). Peripheral artery tonometry measures blood flow in the tip of the index finger at baseline and in response to vaso-occlusion (inflated blood pressure cuff). The reactive hyperemia index is an index of vasodilation after occlusion compared to baseline. A higher value indicates better vasoreactivity. As this is a relatively new test, there are no thoroughly validated clinically utilized norms.|6 months|||(index)||Standard Error|Mean
732916|NCT00413400|Secondary|Glucose Tolerance|Fasting glucose (mg/dL) at 6mo|6 months|||mg/dL||Standard Error|Mean
732917|NCT00413400|Primary|Adiponectin|The ratio of circulating high molecular weight (HMW) adiponectin to total adiponectin ratio (HMW:total Adiponectin) at 6 months is reported.|6 months|||(ratio)||Standard Error|Mean
732918|NCT00413400|Primary|Interleukin-6 (IL-6)|6 month value of IL-6 (pg/mL)|6 months|||pg/mL||Standard Error|Mean
732919|NCT00413400|Primary|C-reactive Protein (CRP)|As a measure of C-reactive protein (CRP), which is an inflammatory marker, Log10 of the CRP at 6 months is reported|6 months|||Log10 mg/L||Standard Error|Mean
732920|NCT00413413|Secondary|Percentage of Patients Achieving Overall Blood Pressure Control at the End of the Study (Week 8)|Overall blood pressure control rate was defined as a msSBP/msDBP < 140/90 mmHg at the end of the study (Week 8). Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated.|End of study (Week 8)|Full-set analysis population: All randomized patients who had a baseline and at least one post-baseline efficacy measurement. For patients who did not complete the Week 8 assessment, a last observation carried forward (LOCF) approach was used.||Percentage of patients|||Number
732921|NCT00413413|Secondary|Percentage of Patients Achieving Diastolic Blood Pressure Control at the End of the Study (Week 8)|Diastolic blood pressure control was defined as a msDBP < 90 mmHg at the end of the study (Week 8). Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated.|End of study (Week 8)|Full-set analysis population: All randomized patients who had a baseline and at least one post-baseline efficacy measurement. For patients who did not complete the Week 8 assessment, a last observation carried forward (LOCF) approach was used.||Percentage of patients|||Number
732922|NCT00413413|Secondary|Percentage of Patients Achieving a Diastolic Blood Pressure Response at the End of the Study (Week 8)|A diastolic blood pressure response was defined as a msDBP < 90 mmHg or a ≥ 10 mmHg decrease compared to baseline at the end of the study (Week 8). Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated.|Baseline to end of study (Week 8)|Full-set analysis population: All randomized patients who had a baseline and at least one post-baseline efficacy measurement. For patients who did not complete the Week 8 assessment, a last observation carried forward (LOCF) approach was used.||Percentage of patients|||Number
732923|NCT00413413|Secondary|Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8)|Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated.|Baseline to end of study (Week 8)|Full-set analysis population population: All randomized patients who had a baseline and at least one post-baseline efficacy measurement. For patients who did not complete the Week 8 assessment, a last observation carried forward (LOCF) approach was used.||mmHg||Standard Error|Least Squares Mean
732924|NCT00413413|Primary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8)|Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated.|Baseline to end of study (Week 8)|Full-set analysis population: All randomized patients who had a baseline and at least one post-baseline efficacy measurement. For patients who did not complete the Week 8 assessment, a last observation carried forward (LOCF) approach was used.||mmHg||Standard Error|Least Squares Mean
732925|NCT00406640|Secondary|Discontinuation-Emergent Signs and Symptoms (DESS) Total Score|DESS is a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of new symptoms and old (but worse) symptoms that appeared during tapering of the test article. A higher score indicates more symptoms. The DESS score was assessed by status of taper.|6 months|Safety population: Randomized patients who took ≥1 dose study drug. Excluded patients lost to follow-up and discontinued with < 4 wks therapy. Patients analyzed varied by time (DVS SR, ESC): End of Therapy (n=264, 267); Taper week 1 (n=217, 227); Taper week 2 (n=222, 223); Post-taper (n=219, 223).||units on scale||Standard Deviation|Mean
732926|NCT00406640|Secondary|Percentage of Non-Responders Achieving Remission at Final Evaluation of 6-month Open-Label Extension Phase|Patients who did not achieve a response to treatment at the end of the 8-week acute double blind phase entered into an open label (OL) treatment phase with DVS SR for 6 months and were evaluated to see if remission was achieved. Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most severe) for a maximum total score of 50.|6 months|All randomized patients who took at least 1 dose of study drug, who did not achieve a response to treatment (≥50% reduction of HAM-D17 total score from baseline) at the end of the acute phase (week 8), entered into the open label extension phase and had baseline and at least 1 post-baseline HAM-D17 evaluation in the acute and open label phase.||Percentage of Non-Responders|||Number
732927|NCT00406640|Secondary|Percentage of Non-Responders Achieving Response at Final Evaluation of 6-month Open-Label (OL)Extension Phase|Patients who didn't achieve a response to treatment at the end of the 8-week acute double blind phase entered into an OL treatment phase with DVS SR for 6 months and were evaluated to see if a response was achieved. A response is defined as ≥ 50% decrease from baseline on Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most severe) for a maximum total score of 50.|6 months|All randomized patients who took at least 1 dose of study drug, who did not achieve a response to treatment (≥50% reduction of HAM-D17 total score from baseline) at the end of the acute phase (week 8), entered into the open label extension phase and had baseline and at least 1 post-baseline HAM-D17 evaluation in the acute and open label phase.||Percentage of Non-Responders|||Number
732928|NCT00406640|Secondary|Percentage of Responders Improving Response to Remission During 6-month Double Blind Continuation Phase|Patients achieving a response to treatment (Responders) at the end of the 8-week acute double blind (DB) phase continued into a 6-month DB phase. Responders without remission at 8 weeks were assessed for remission status during the 6-month continuation. Remission defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale assessing 17 items characteristically associated with major depression. Individual items scored on a 0 to 2 or 4 scale (0=none/absent and 4=most severe) for a maximum total score of 50.|6 months|All randomized patients with baseline HAM-D17 score ≥18, who took ≥1 dose study drug, had ≥1 post-baseline HAM-D17 evaluation, achieved a response to treatment (≥50% reduction of HAM-D17 total score from baseline) but not remission (HAM-D17 score ≤ 7) at the end of the acute phase and continued treatment in the 6-month DB continuation phase.||percentage of responders|||Number
732929|NCT00406640|Secondary|Percentage of Responders Achieving Remission at Final On-therapy Evaluation (Double Blind Continuation Phase)|Patients achieving a response to treatment at the end of the 8-week acute double blind (DB) phase continued the same treatment in a 6-month DB continuation phase and were evaluated to see if remission was achieved. Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most severe) for a maximum total score of 50.|6 months|All randomized patients with a baseline HAM-D17 score ≥18, who took at least 1 dose of study drug, had at least 1 post-baseline HAM-D17 evaluation, achieved a response to treatment (≥50% reduction of HAM-D17 total score from baseline) at the end of the acute phase (week 8) and continued treatment in the double blind continuation phase.||percentage of responders|||Number
732930|NCT00406640|Secondary|Percentage of Responders Maintaining Response to Treatment at Final On-therapy Evaluation (Double Blind Continuation Phase)|Patients achieving a response to treatment at the end of the 8-week acute double blind (DB) phase continued the same treatment in a 6-month DB continuation phase and were evaluated to see if the response was maintained. A response is defined as ≥ 50% decrease from baseline on Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most severe) for a maximum total score of 50.|6 months|All randomized patients with a baseline HAM-D17 score ≥18, who took at least 1 dose of study drug, had at least 1 post-baseline HAM-D17 evaluation, achieved a response to treatment (≥50% reduction of HAM-D17 total score from baseline) at the end of the acute phase (week 8) and continued treatment in the double blind continuation phase.||percentage of responders|||Number
732931|NCT00406640|Secondary|Change in Dimension Health State EuroQol (EQ-5D) Score From Baseline to Week 8|EQ-5D is a standardized, subject-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point visual analog scale (0=worst, 100=best). EQ-5D summary index is obtained with a formula that weights each level of the dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health). Change=8 week score minus baseline score.|Baseline and week 8|Acute Double-blind phase; all randomized patients with a baseline HAM-D17 score ≥ 18, who took at least 1 dose of study drug and had at least 1 post-baseline HAM-D17 evaluation.||units on scale||Standard Error|Mean
732932|NCT00406640|Secondary|Change in Hamilton Psychiatric Rating Scale for Anxiety From Baseline to Week 8 (HAM-A) Score|The HAM-A is a standardized, clinician-administered rating scale that assesses 14 items characteristically associated with major anxiety disorders. Items are scaled 0 - 4 (0=none and 4=very severe), with a maximum total score of 56. Change= 8 week adjusted mean HAM-A total score minus baseline adjusted mean total score.|Baseline and Week 8|Acute Double-blind phase; all randomized patients with a baseline HAM-D17 score ≥ 18, who took at least 1 dose of study drug and had at least 1 post-baseline HAM-D17 evaluation.||units on scale||Standard Deviation|Mean
732933|NCT00406640|Secondary|Change in Clinical Global Impression Severity (CGI-S) Score From Baseline to Week|CGI-S is a global rating scale that measures the severity of a patient’s disease. Using a 7-point scale, the clinician rates the severity of the patient’s mental illness at the time of the assessment, relative to the clinician’s experience with patients who have the same diagnosis (1= normal; 7= extremely ill).|Baseline and 8 weeks|Acute double-blind phase; all randomized patients with a baseline HAM-D17 score ≥18, took at least1 dose of study drug and had at least1 post-baseline HAM-D17 evaluation.||units on scale||Standard Error|Mean
732934|NCT00406640|Secondary|Clinical Global Impression Improvement (CGI-I) Score at 8 Weeks|CGI-I is a global rating scale that measures disease improvement. Using a 7-point scale, the clinician rates how much the patient's illness has improved or worsened relative to the baseline status (1= very much improved; 7= very much worse).|8 weeks|Acute double-blind phase; all randomized patients with a baseline HAM-D17 score ≥18, took at least1 dose of study drug and had at least1 post-baseline HAM-D17 evaluation.||units on scale||Standard Error|Mean
732991|NCT00406848|Secondary|Change From Baseline in Supine Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)||baseline (Week 1), Week 13, Week 25|All randomized patients with a baseline and at least one non-missing post-baseline value.||mmHg||Standard Error|Least Squares Mean
732935|NCT00406640|Secondary|Percentage of Patients Achieving Remission at Final On-therapy Evaluation (Acute Phase)|Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most severe) for a maximum total score of 50.|8 weeks|Acute double-blind phase; all randomized patients with a baseline HAM-D17 score ≥18, who took at least 1 dose of study drug and had at least 1 post-baseline HAM-D17 evaluation.||Percentage of patients|||Number
732936|NCT00406640|Secondary|Percentage of Patients Achieving Response to Treatment at Final On-therapy Evaluation (Acute Phase)|A response is defined as ≥ 50% decrease from baseline on Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most severe) for a maximum total score of 50.|8 weeks|Acute double-blind phase; all randomized patients with a baseline HAM-D17 score ≥18, who took at least 1 dose of study drug and had at least 1 post-baseline HAM-D17 evaluation.||percentage of patients|||Number
732937|NCT00406640|Primary|Change in Hamilton Psychiatric Rating Scale for Depression (HAM-D17) Score From Baseline to Week 8|HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4) with 0=none/absent and 4=most severe,for a maximum total score of 50. Change= 8 week adjusted mean HAM-D17 minus baseline adjusted mean HAM-D17.|Baseline and 8 weeks|Acute Double-blind phase; all randomized patients with a baseline HAM-D17 score ≥ 18, who took at least 1 dose of study drug and had at least 1 post-baseline HAM-D17 evaluation.||units on scale||Standard Error|Mean
732938|NCT00406653|Secondary|OL; Number of Participants With Pharmacogenomic Marker Activity|Changes in the expression of individual ribonucleic acid (RNA) transcripts were to be evaluated from whole blood using both microarray transcriptional profiling and quantitative polymerase chain reaction (PCR) methods. Peripheral RNA transcriptional profiling was to be used only to identify individual RNA transcripts that differ in expression with respect to time, treatment and outcome.|Between Day OL-1 and Day OL-617|Due to the early termination of the study after the IP results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analysis of pharmacogenomic marker activity in participants was not conducted for the OL as planned.||participants|||Number
732939|NCT00406653|Secondary|OL; Number of Participants With Positive Antibody Response to Abatacept|A electrochemiluminescent immunoassay screened sera for drug-specific antibodies, immunocompetition was used to identify specific anti-Abatacept reactivity. CTLA4 and Possibly Ig category= reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing.|For participants receiving OL medication, all measurements starting after Day OL-1 (including follow-up visits and at 56 and 85 days after last dose)|All participants who received abatacept and for whom baseline and at least 1 additional measurement were available were included in the Immunogenicity Analysis Population.||participants|||Number
732940|NCT00406653|Secondary|OL; Number of Participants With CDAI-defined Clinical Response or Clinical Remission at Day OL-365|CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant’s Diary kept while on study. CDAI scores range from 0 to ~600 points. Clinical response=CDAI reduction ≥100 points or absolute CDAI <150 points. Clinical remission=CDAI <150 points. Moderate to severe disease=CDAI ≥220 and ≤450 points.|Day OL-365|All Randomized and Treated (receiving ≥1 infusion) Participants in Open-Label Extension Period.||participants|||Number
732941|NCT00406653|Secondary|OL; Number of Participants With CDAI-defined Clinical Response or Clinical Remission at Day OL-169|CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant’s Diary kept while on study. CDAI scores range from 0 to ~600 points. Clinical response=CDAI reduction ≥100 points or absolute CDAI <150 points. Clinical remission=CDAI <150 points. Moderate to severe disease=CDAI ≥220 and ≤450 points.|Day OL-169|All Randomized and Treated (receiving ≥1 infusion) Participants in Open-Label Extension Period.||participants|||Number
732942|NCT00406653|Secondary|OL; Number of Participants Who Were Not On Background Corticosteroid Therapy Among All Participants Who Received Baseline Corticosteroid Therapy|Background corticosteroid therapy included prednisone or budesonide.|Between Day OL-1 and Day OL-617|Due to the early termination of the study after the IP results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analysis of corticosteroid use in participants was not conducted for the OL as planned.||participants|||Number
732943|NCT00406653|Secondary|MP; Number of Participants in CDAI-Defined Clinical Remission Among Participants With Inadequate Response and/or Intolerance to Anti-TNF|CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant’s Diary kept while on study. CDAI scores range from 0 to ~600 points. Clinical response=CDAI reduction ≥100 points or absolute CDAI <150 points. Clinical remission=CDAI <150 points. Moderate to severe disease=CDAI ≥220 and ≤450 points.|Day MP-365|Due to the early termination of the study after the IP results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint subgroup analysis of clinical remission in participants who have had an inadequate response and/or intolerance to anti-TNF therapy was not conducted for the MP as planned.||participants|||Number
732944|NCT00406653|Secondary|MP; Number of Participants With CDAI-Defined Clinical Response Among Participants With Inadequate Response and/or Intolerance to Anti-Tumor Necrosis Factor (TNF)|CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant’s Diary kept while on study. CDAI scores range from 0 to ~600 points. Clinical response=CDAI reduction ≥100 points or absolute CDAI <150 points. Clinical remission=CDAI <150 points. Moderate to severe disease=CDAI ≥220 and ≤450 points.|Day MP-365|Due to the early termination of the study after the IP results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint subgroup analysis of clinical response in participants who have had an inadequate response and/or intolerance to anti-TNF therapy was not conducted for the MP as planned.||participants|||Number
732945|NCT00406653|Secondary|MP; Number of Participants Who Were Not On Background Corticosteroid Therapy at Day MP-365 Among Participants Who Received Baseline Corticosteroid Therapy and Who Achieved CDAI-Defined Clinical Remission|CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score is based partly on entries from participant’s Diary (7 days before evaluation) which is kept while on study. CDAI scores range from 0 to ~600. Clinical response=CDAI reduction ≥100 or absolute CDAI <150. Clinical remission=CDAI <150. Moderate to severe disease=CDAI ≥220 and ≤450.|Day MP-365|On/after Day MP-1, a defined tapering of corticosteroids was planned if the participant was in remission/had improved. Due to the early termination of the study after the IP results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analyses for corticosteroid sparing were not conducted for the MP as planned.||participants|||Number
732946|NCT00406653|Secondary|MP; Number of Participants Who Were Not On Background Corticosteroid Therapy at Day MP-365 Among All Participants Who Received Baseline Corticosteroid Therapy|Participants who received corticosteroid therapy (e.g. prednisone or budesonide) were to maintain a stable dose until Day MP-1. On or after Day MP-1, a recommended tapering regimen of corticosteroid therapy was planned if the participant was in remission (i.e., CDAI score < 150), or if the participant’s condition had satisfactorily improved according to investigators clinical assessment. Other CD therapy was to remain at a stable dose throughout the Maintenance Period, with the exception of decreases due to drug-related toxicities.|Day MP-365|On/after Day MP-1, a recommended tapering of corticosteroids was planned if participant was in remission/had improved. Due to the early termination of the study after the IP results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analyses for corticosteroid sparing were not conducted for the MP as planned||participants|||Number
732947|NCT00406653|Secondary|MP; Change From Baseline to Day MP-365 in Inflammatory Bowel Disease Questionnaire (IBDQ)|The Inflammatory Bowel Disease Questionnaire (IBDQ) consists of a self-administered 32-item questionnaire evaluating quality of life across 4 dimensional scores: Bowel, Systemic, Social and Emotional. Responses to each question can range from 1 to 7, with 1 indicating severe problem and 7 indicating normal health. The total IBDQ is computed as the sum of the responses to the individual IBDQ questions. The total score ranges between 32 to 224 with higher scores indicating a better quality of life. Change from Baseline= post-baseline - Baseline value.|Baseline, Day MP-365|Due to the early termination of the study after the IP results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analysis for changes from baseline in IBDQ responses were not conducted for the MP as planned.||units on a scale||Standard Deviation|Mean
732948|NCT00406653|Secondary|MP; Change From Baseline to Day MP-365 in Short Form-36 (SF-36)|The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.|Baseline, Day MP-365|Due to the early termination of the study after the IP results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analysis for changes from baseline in SF-36 responses were not conducted for the MP as planned.||units on a scale||Standard Deviation|Mean
732949|NCT00406653|Secondary|MP; Number of Participants in CDAI-defined Clinical Remission at Both Day MP-169 and Day MP-365|CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant’s Diary kept while on study. CDAI scores range from 0 to ~600 points. Clinical response=CDAI reduction ≥100 points or absolute CDAI <150 points. Clinical remission=CDAI <150 points. Moderate to severe disease=CDAI ≥220 and ≤450 points.|Day MP-169|Due to the early termination of the study after the IP results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analysis for the cohort of participants with clinical remission at both Day MP-169 and Day MP-365 was not conducted for the MP as planned.||participants|||Number
732950|NCT00406653|Primary|OL; Number of Participants With Adverse Events (AEs) of Special Interest|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).|Between Day OL-1 and Day OL-617|All participants who received at least 1 infusion of open-label study medication at any time, based on a participant’s received treatment (As Treated Analysis Population)||participants|||Number
733206|NCT00414908|Secondary|Abdominal Pain at the End of the Double-blind Period.|4- point ordinal scale on this symptom from 0 (No Abdominal pain) to 3 (Severe abdominal pain).|End of double-period (5-7 days)|The analysis was done on the Full Analysis sample. Full Analysis Population consists of all subjects who were allocated to the treatment and had data for at least one post-baseline assessment of any efficacy measurement.||Participants|||Number
732951|NCT00406653|Secondary|MP; Number of Participants With CDAI-defined Clinical Response at Day MP-365.|CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant’s Diary kept while on study. CDAI scores range from 0 to ~600 points. Clinical response=CDAI reduction ≥100 points or absolute CDAI <150 points. Clinical remission=CDAI <150 points. Moderate to severe disease=CDAI ≥220 and ≤450 points.|Day MP-365|All Randomized and Treated (receiving ≥1 infusion) Participants in Maintenance Period. Due to site non-compliance with the study protocol, 1 randomized and treated participant from Site 166 was excluded.||participants|||Number
732952|NCT00406653|Secondary|MP; Number of Participants With Positive Antibody Response to Abatacept|A electrochemiluminescent immunoassay screened sera for drug-specific antibodies, immunocompetition was used to identify specific anti-Abatacept reactivity. CTLA4 and Possibly Ig category= reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing.|For participants not entering OL: All measurements after Day MP-1 (including follow-up visits); For participants entering OL: From first measurement after Day MP-1 to Day MP-365 (Day OL-1)|All participants who received abatacept and for whom baseline and at least 1 additional measurement were available were included in the Immunogenicity Analysis Population. The placebo group was constituted by participants who received abatacept in the IP and underwent drug withdrawal in the MP.||participants|||Number
732953|NCT00406653|Secondary|MP; Number of Participants With Adverse Events (AEs) of Special Interest:|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).|Between Day IP-85 and Day MP-365|All participants who received at least 1 infusion of study medication during the MP, based on a participant’s received treatment (As Treated Analysis Population)||participants|||Number
732954|NCT00406653|Secondary|MP; Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and Discontinuation Due To AEs|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|Between Day IP-85 and Day MP-365|All participants who received at least 1 infusion of study medication during the Maintenance Period, based on a participant’s received treatment (As Treated Analysis Population)||Participants|||Number
732955|NCT00406653|Secondary|IP; Number of Participants Who Are Anti-TNF-Inadequate Responders/Anti-TNF Intolerant With CDAI-Defined Clinical Response at Both Day IP-57 and Day IP-85 Analyzed by Cochran-Armitage Trend Test for Dose-Response Relationship|CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant’s Diary kept while on study. CDAI scores range from 0 to ~600 points. Clinical response=CDAI reduction ≥100 points or absolute CDAI <150 points. Clinical remission=CDAI <150 points. Moderate to severe disease=CDAI ≥220 and ≤450 points.|At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12) of induction therapy|Participants in the All Randomized and Treated (receiving ≥1 infusion) Population who in the past had an inadequate response to, or who were intolerant to, an approved anti-TNF agent at an approved labeled dose for at least 8 weeks. Due to site non-compliance with the study protocol, 1 randomized and treated participant from Site 166 was excluded.||participants|||Number
732956|NCT00406653|Secondary|IP; Number of Participants in CDAI-Defined Clinical Remission at Both Day IP-57 and Day IP-85 Among Participants With Inadequate Response and/or Intolerance to Anti-TNF|CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant’s Diary kept while on study. CDAI scores range from 0 to ~600 points. Clinical response=CDAI reduction ≥100 points or absolute CDAI <150 points. Clinical remission=CDAI <150 points. Moderate to severe disease=CDAI ≥220 and ≤450 points.|At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12) of induction therapy|Participants in the All Randomized and Treated (receiving ≥1 infusion) Population who in the past had an inadequate response to, or who were intolerant to, an approved anti-TNF agent at an approved labeled dose for at least 8 weeks. Due to site non-compliance with the study protocol, 1 randomized and treated participant from Site 166 was excluded.||participants|||Number
732957|NCT00406653|Secondary|IP; Number of Participants With CDAI-Defined Clinical Response at Both Day IP-57 and Day IP-85 Among Participants With Inadequate Response and/or Intolerance to Anti-Tumor Necrosis Factor (TNF)|CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant’s Diary kept while on study. CDAI scores range from 0 to ~600 points. Clinical response=CDAI reduction ≥100 points or absolute CDAI <150 points. Clinical remission=CDAI <150 points. Moderate to severe disease=CDAI ≥220 and ≤450 points.|At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12) of induction therapy|Participants in the All Randomized and Treated (receiving ≥1 infusion) Population who in the past had an inadequate response to, or who were intolerant to, an approved anti-TNF agent at an approved labeled dose for at least 8 weeks. Due to site non-compliance with the study protocol, 1 randomized and treated participant from Site 166 was excluded.||participants|||Number
732958|NCT00406653|Secondary|IP; Number of Participants With Positive Antibody Response to Abatacept (ABA)|A electrochemiluminescent immunoassay screened sera for drug-specific antibodies, immunocompetition identified specific anti-ABA reactivity. Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) and Possibly immunoglobulin (Ig) category= reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing.|For participants treated in MP: Day IP-1 (Baseline) to Day MP-1 (Day IP-85); For participants treated in OL directly after IP: Day IP-1 to Day OL-1; For participants treated only in IP: All measurements after Day IP-1 (including follow-up visits)|All participants who received abatacept and for whom baseline and at least 1 additional measurement were available were included in the Immunogenicity Analysis Population.||participants|||Number
732959|NCT00406653|Secondary|IP; Number of Participants With Adverse Events (AEs) of Special Interest|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).|Day IP-1 through Day IP-85|All participants who received at least 1 infusion of study medication during the IP, based on a participant’s received treatment (As Treated Analysis Population)||participants|||Number
732960|NCT00406653|Secondary|IP; Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and Discontinuation Due to AEs|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|Day IP-1 through Day IP-85|All participants who received at least 1 infusion of study medication during the Induction Period, based on a participant’s received treatment (As Treated Analysis Population)||Participants|||Number
732961|NCT00406653|Secondary|IP; Change From Baseline to Day IP-85 In Inflammatory Bowel Disease Questionnaire (IBDQ)|The Inflammatory Bowel Disease Questionnaire (IBDQ) consists of a self-administered 32-item questionnaire evaluating quality of life across 4 dimensional scores: Bowel, Systemic, Social and Emotional. Responses to each question can range from 1 to 7, with 1 indicating severe problem and 7 indicating normal health. The total IBDQ is computed as the sum of the responses to the individual IBDQ questions. The total score ranges between 32 to 224 with higher scores indicating a better quality of life. Change from Baseline= post-Baseline - Baseline value.|Baseline, Day IP-85|All Randomized and Treated (receiving ≥1 infusion) Participants in Induction Period with both Baseline and post-Baseline measurements.||units on a scale||Standard Deviation|Mean
732962|NCT00406653|Secondary|IP; Number of Participants With CDAI-Defined Clinical Response at Both Day IP-57 and Day IP-85 Analyzed by Cochran-Armitage Trend Test for Dose-Response Relationship|CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant’s Diary kept while on study. CDAI scores range from 0 to ~600 points. Clinical response=CDAI reduction ≥100 points or absolute CDAI <150 points. Clinical remission=CDAI <150 points. Moderate to severe disease=CDAI ≥220 and ≤450 points.|At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12) of induction therapy|All Randomized and Treated (receiving ≥1 infusion) Participants in Induction Period||participants|||Number
732963|NCT00406653|Secondary|IP; Number of Participants in CDAI-defined Clinical Remission at Both Day IP-57 and Day IP-85 (Key Secondary Outcome)|CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant’s Diary kept while on study. CDAI scores range from 0 to ~600 points. Clinical response=CDAI reduction ≥100 points or absolute CDAI <150 points. Clinical remission=CDAI <150 points. Moderate to severe disease=CDAI ≥220 and ≤450 points.|At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12) of induction therapy|All Randomized and Treated (receiving ≥1 infusion) Participants in Induction Period||participants|||Number
732964|NCT00406653|Primary|Open-Label Extension Period (OL); Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and Discontinuation Due to AEs|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|Between Day OL-1 and Day OL-617|All participants who received at least 1 infusion of open-label study medication at any time, based on a participant’s received treatment (As Treated Analysis Population). The OL was not sized based on power considerations.||participants|||Number
732992|NCT00406848|Secondary|Probability of Efficacy Onset as Measured by at Least 20% Sustained Reduction From Baseline in the HAMD-17 Maier Subscale at Week 3|Patients are considered to have met onset (visitwise binary outcome, yes/no) criteria at a particular visit if they had at least 20% reduction from baseline in the HAMD-17 Maier subscale at that visit and at all subsequent visits in the acute phase. Maier subscale measures core symptoms of depression and scores range from 0 (normal) to 24 (severe). The visitwise probability of patients meeting onset criteria was analyzed using a categorical, pseudo-likelihood-based repeated measures approach.|Week 3|All participants randomized under protocol amendment c,d,e, and have a baseline observation and at least one post-randomization observation.||Probability of onset||Standard Error|Least Squares Mean
732965|NCT00406653|Primary|Maintenance Period (MP); Number of Participants In CDAI-Defined Clinical Remission (CDAI <150) at Day MP-365 (12 Months)|CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant’s Diary kept while on study. CDAI scores range from 0 to ~600 points. Clinical response=CDAI reduction ≥100 points or absolute CDAI <150 points. Clinical remission=CDAI <150 points. Moderate to severe disease=CDAI ≥220 and ≤450 points.|Day MP-365 (12 months) of maintenance therapy|All Randomized and Treated (receiving ≥1 infusion) Participants in Maintenance Period. The Maintenance Period was not sized based on power considerations, and thus, no formal statistical hypothesis testing was performed.||participants|||Number
732966|NCT00406653|Primary|Induction Period (IP); Number of Participants With Crohn's Disease Activity Index (CDAI)-Defined Clinical Response at Both Day IP-57 and Day IP-85|CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant’s Diary kept while on study. CDAI scores range from 0 to ~600 points. Clinical response=CDAI reduction ≥100 points or absolute CDAI <150 points. Clinical remission=CDAI <150 points. Moderate to severe disease=CDAI ≥220 and ≤450 points.|At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12).|All Randomized and Treated (receiving ≥1 infusion) Participants in Induction Period. Due to site non-compliance with the study protocol, 1 randomized and treated participant from Site 166 was excluded.||participants|||Number
732967|NCT00406692|Secondary|Symbol Digit Modalities Test (DSMT)|Number of correct digit substitutions on the DSMT per session with the possible maximum score being 188. The value shown is for difference between mean scores obtained for baseline and week 12 sessions.|Baseline, Week 12|ITT||Units on a scale||Standard Error|Mean
732968|NCT00406692|Primary|Difference in Mean Words for the Phonetic Portion of the Controlled Word Association Test (COWAT).|Subjects were asked to generate as many words as possible starting with a particular letter over a 60 second period. Three letters were used for each sessions. Values shown are the differences between values obtained for the baseline and week 12 test session.|Week 0- Baseline and Week 12|ITT||Number of Words||Standard Error|Mean
732969|NCT00406692|Primary|The Weekly Mean Number of Standard Drinks Consumed Per Day at Baseline and Treatment Phase|The mean daily standard alcoholic drinks were determined for the baseline period and each treatment week as a measure of alcohol intake. One standard drink=14g of alcohol. Mean value is the difference between mean standard drinks for the baseline period and week 12 of the study.|Baseline and Week 12|ITT||Standard Drinks||Standard Error|Mean
732970|NCT00406718|Secondary|Schizophrenia Symptoms|Brief Psychiatric Rating Scale (BPRS) expanded version psychosis subscale, mean of items for unusual thought content, auspiciousness, conceptual disorganization, and hallucinations. Higher scores mean greater level of symptomatology. Scores vary from 1 = absent to 7 = severe|Measured at Months 4, 7, and 10 months averaged across the treatment period which began 1 month after study baseline and ended at month 10 (total 9 mos of treatment)|All subjects with a baseline and at least one follow up rating||units on a scale||Standard Deviation|Mean
732971|NCT00406718|Primary|Social and Occupational Functioning Assessment Scale (SOFAS) Scores|Scale from 1-100 rating global social and occupational functioning. Higher scores indicate better functional outcomes|Measured at Months 4, 7, and 10 months averaged across the treatment period which began 1 month after study baseline and ended at month 10 (total 9 mos of treatment)|Patients with baseline and at least one follow up rating||Units on a scale||Standard Deviation|Mean
732972|NCT00406718|Primary|Adherence|Adherence derived from electronic monitoring. Percentage of medication taken during each preceding 3 month period, averaged across treatment period.|Measured at Months 4, 7, and 10 months averaged across the treatment period which began 1 month after study baseline and ended at month 10 (total 9 mos of treatment)|All individuals randomized who had a baseline and at least one follow-up rating||Percentage of medication taken||Standard Deviation|Mean
732973|NCT00406783|Other Pre-specified|Rhinoconjunctivitis Quality of Life Questionnaire-Standardized Version (RQLQ-S: BASELINE|The RQLQ-S questionnaire consists of 28 questions grouped into 7 domains. Each question is scored on a scale of 0 (not troubled with symptoms) to 6 (extremely troubled with symptoms). The total RQLQ-S score is the average score of the 28 questions which consisted of a total of 7 domains.|Baseline|Last Observation Carried Forward (LOCF) to the final visit. The RQLQ-S was only completed for subjects >=18 years of age and where available in the local language.||scores on a scale||Standard Error|Least Squares Mean
732974|NCT00406783|Other Pre-specified|Total 5 Symptom Score (T5SS) - Average AM/PM PRIOR (Reflective) 12 Hours Diary: BASELINE|AM/PM is the average of separate morning (AM) and evening (PM) evaluations. T5SS = the sum of the individual scores for nasal congestion/stuffiness, sneezing, rhinorrhea/nasal discharge, nasal pruritis, and ocular pruritis. Each individual symptom/sign was scored from 0 (none) to 3 (severe).|Baseline|Last Observation Carried Forward (LOCF) to the final visit. All randomized subjects with a non-missing baseline and at least some post-baseline data were included in the analyses.||scores on a scale||Standard Error|Least Squares Mean
732975|NCT00406783|Secondary|Change From Baseline in the Rhinoconjunctivitis Quality of Life Questionnaire-Standardized Version (RQLQ-S) at the Final Visit|The RQLQ-S questionnaire consists of 28 questions grouped into 7 domains. Each question is scored on a scale of 0 (not troubled with symptoms) to 6 (extremely troubled with symptoms). The total RQLQ-S score is the average score of the 28 questions which consisted of a total of 7 domains.|15 days|Last Observation Carried Forward (LOCF) to the final visit. The RQLQ-S was only completed for subjects >=18 years of age and where available in the local language.||scores on a scale||Standard Error|Least Squares Mean
732976|NCT00406783|Primary|The Change From Baseline in the 12-hour AM/PM-PRIOR (Reflective) Total 5 Symptom Score (T5SS) From Subject Daily Diaries Averaged Over Treatment Days 1 to 15|AM/PM is the average of separate morning (AM) and evening (PM) evaluations. T5SS = the sum of the individual scores for nasal congestion/stuffiness, sneezing, rhinorrhea/nasal discharge, nasal pruritis, and ocular pruritis. Each individual symptom/sign was scored from 0 (none) to 3 (severe).|15 days|Last Observation Carried Forward (LOCF) to the final visit. All randomized subjects with a non-missing baseline and at least some post-baseline data were included in the analyses.||scores on a scale||Standard Error|Least Squares Mean
732977|NCT00406848|Secondary|Change From Baseline on Cognitive Test Scores: Verbal Learning and Recall Test (VLRT), Symbol Digit Substitution Test (SDST), Trail Making Test (Part B), 2-Digit Cancellation Test (2DCT), and the Composite Cognitive Score Derived From the Above Scores|The cognitive assessment battery is composed of four tests: Verbal Learning (score 0-15)and Delayed Recall(score 0-15) test, SDST(Score 0-133),2DCT(score 0-40),Trail Making(Part B)(score 0-180).They are designed to challenge the patient's abilities in the following areas: verbal learning and memory; attention to visually presented material; and working memory and executive function. Composite Cognitive score(0-51)is derived from normalized individual test scores. For Trail Making Test,lower number indicates better cognition. For all other test scores,higher number indicates better cognition.|baseline (Week 1), Week 9, Week 25|All participants randomized under protocol amendment c,d,e, and have a baseline observation and at least one post-randomization observation.||units on a scale||Standard Error|Least Squares Mean
732978|NCT00406848|Secondary|Number of Participants With Successful Treatment Outcome|Successful treatment outcome defined as: Participant completed the study and being in remission (HAMD-17 Total score ≤7 and ≤10) at least for the last two visits (4 weeks)of the study. The HAMD-17 is used to assess the severity of depression. The total score ranges from 0 (not at all depressed) to 52 (severely depressed).|Baseline (Week 1) through Week 25|All participants randomized under protocol amendment c,d,e, and that have non-missing successful treatment values.||participants|||Number
732979|NCT00406848|Secondary|Change From Baseline in Electrocardiograms|The Electrocardiogram measures include the following time intervals: QT interval, QT Interval Corrected for Heart Rate Using Fridericia’s Formula (QTcF), QT Interval Corrected for Heart Rate Using Bazett's Formula (QTcB), PR interval and QRS interval.|baseline (Week 1), Week 25|Participants with a baseline and at least one non-missing post baseline value.||millisecond (msec)||Standard Error|Least Squares Mean
732980|NCT00406848|Secondary|Number of Participants With Abnormal Laboratory Values - Low Leukocyte Count|The number of participants with abnormal laboratory values at any time during the study period. Results are reported for laboratory analytes that exhibited statistically significantly different proportions of participants who had abnormal values between treatment groups. Statistical significance was considered at the 0.05 level. The lower limit of normal for leukocyte count is 3.8 Billion/Liter. Participants who had a value below that number were considered to have abnormally low leukocyte count.|baseline (Week 1) through Week 13|All randomized patients with a normal baseline and at least one post-baseline value in each treatment group.||participants|||Number
732981|NCT00406848|Secondary|Change From Baseline in Laboratory Values - Chloride and Fasting Glucose|Results are reported for laboratory analytes that exhibited statistically significantly different changes from baseline to endpoint between treatment groups. Statistical significance was considered at the 0.05 level.|baseline (Week 1), Week 25|All randomized patients with a baseline and at least one post-baseline value in each treatment group.||millimole/liter||Standard Deviation|Mean
732982|NCT00406848|Secondary|Change From Baseline in Laboratory Values - Hemoglobin, Mean Cell Hemoglobin Concentration (MCHC)|Results are reported for laboratory analytes that exhibited statistically significantly different changes from baseline to endpoint between treatment groups. Statistical significance was considered at the 0.05 level.|baseline (Week 1), Week 25|All randomized patients with a baseline and at least one post-baseline value in each treatment group.||Micromole/liter (Fe)||Standard Deviation|Mean
732983|NCT00406848|Secondary|Change From Baseline in Laboratory Values - Erythrocyte Count|Results are reported for laboratory analytes that exhibited statistically significantly different changes from baseline to endpoint between treatment groups. Statistical significance was considered at the 0.05 level.|baseline (Week 1), Week 25|All randomized patients with a baseline and at least one post-baseline value in each treatment group.||Trillion/Liter||Standard Deviation|Mean
732984|NCT00406848|Secondary|Change From Baseline in Laboratory Values - Uric Acid|Results are reported for laboratory analytes that exhibited statistically significantly different changes from baseline to endpoint between treatment groups. Statistical significance was considered at the 0.05 level.|baseline (Week 1), Week 13, Week 25|All randomized patients with a baseline and at least one post-baseline value in each treatment group.||micromole/liter||Standard Deviation|Mean
732985|NCT00406848|Secondary|Change From Baseline in Laboratory Values - Platelet Count|Results are reported for laboratory analytes that exhibited statistically significantly different changes from baseline to endpoint between treatment groups. Statistical significance was considered at the 0.05 level.|baseline (Week 1), Week 13, Week 25|All randomized patients with a baseline and at least one post-baseline value in each treatment group.||billions per liter (bill/L)||Standard Deviation|Mean
732986|NCT00406848|Secondary|Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation|Adverse Events and Serious Adverse Events leading to study discontinuation.|baseline (Week 1) through Week 25|All randomized patients.||participants|||Number
732987|NCT00406848|Secondary|Number of Participants Experiencing Sustained Hypertension (SH) or Orthostatic Hypotension (OH)|Sustained Hypertension is defined as supine systolic BP >= 140 (or diastolic BP >= 90) mm Hg and increase from baseline (highest value in baseline visit interval) >= 10 mm Hg for 3 or more consecutive visits in postbaseline visit interval. Orthostatic Hypotension is defined as standing diastolic BP at least 10 mm Hg less than the supine diastolic BP or the standing systolic BP at least 20 mm Hg less than the supine systolic BP at any time in postbaseline visit interval and a patient does not meet this criterion at any visit in baseline interval.|baseline (Week 1) through Week 25|All randomized patients with a normal baseline and at least one post-baseline value in each treatment group.||Participants|||Number
732988|NCT00406848|Secondary|Number of Participants With Abnormal Vital Signs and Weight at Any Time During the Study|"A patient has a treatment-emergent elevated supine systolic blood pressure if the value is ≥140 with an increase ≥10 from baseline. A patient has a treatment-emergent elevated supine diastolic blood pressure if the value is ≥90 with an increase ≥10 from baseline. A patient has a treatment-emergent elevated supine pulse if the value is ≥100 with an increase ≥10 from baseline.
A patient has abnormal weight change if the gain or loss is ≥7% compared to baseline."|Baseline (Week 1) through Week 25|All randomized patients with a normal baseline and at least one post-baseline value in each treatment group.||Participants|||Number
732989|NCT00406848|Secondary|Change From Baseline in Weight||baseline (Week 1), Week 13, Week 25|All randomized patients with a baseline and at least one non-missing post-baseline value.||kilograms (kg)||Standard Error|Least Squares Mean
733013|NCT00407355|Primary|Retinal Thickness Change From Baseline at All Visits||continuous through 72 mos|||microns||Standard Deviation|Mean
732993|NCT00406848|Secondary|Probability of Remission as Measured by the HAMD-17 Total Score ≤7 and ≤10 by Medical Comorbidity Severity as Assessed by the Cumulative Illness Rating Scale-Geriatric Version (CIRS-G)|Remission defined as HAMD-17 Total Score ≤7 and ≤10. HAMD-17 measures depression severity. Total score ranges: 0 (normal) to 52 (severe depression). Visitwise probability of patients achieving remission was analyzed using a categorical, pseudo-likelihood-based repeated measures approach. CIRS-G evaluates 14 organ-specific categories using a rating strategy of 0=no problems; 1=current mild problem/past significant problem; 2=moderate disability/morbidity; 3=severe/constant significant disability; and 4=extremely severe/immediate treatment required/end organ failure. Total score ranges: 0 to 56.|Week 13, Week 25|Randomized patients with non-missing data at baseline and post-baseline visit.||probability of remission||Standard Error|Least Squares Mean
732994|NCT00406848|Secondary|Probability of Response at Endpoint as Measured by ≥50% Improvement in the HAMD-17 Total Score|Response (visitwise binary outcome, yes/no) is defined as ≥ 50% reduction from baseline in the HAMD-17 total score. HAMD-17 measures depression severity. The total score can range from 0 (normal) to 52 (severe depression). The visitwise probability of patients meeting criteria for response was analyzed using a categorical, pseudo-likelihood-based repeated measures approach. This analysis included the fixed, categorical effects of treatment, investigator, visit, and treatment-by-visit interaction, as well as the continuous, fixed covariate of baseline score.|Week 13, Week 25|All participants randomized under protocol amendment c,d,e, and have a baseline observation and at least one post-randomization observation.||probability of response||Standard Error|Least Squares Mean
732995|NCT00406848|Secondary|Probability of Remission as Measured by the HAMD-17 Total Score ≤7 and ≤10|Remission (visitwise binary outcome, yes/no) is defined as HAMD-17 Total Score ≤7 and ≤10. HAMD-17 measures depression severity. The total score can range from 0 (normal) to 52 (severe depression). The visitwise probability of patients meeting criteria for remission (either Total Score ≤7 or ≤10) was analyzed using a categorical, pseudo-likelihood-based repeated measures approach. This analysis included the fixed, categorical effects of treatment, investigator, visit, and treatment-by-visit interaction, as well as the continuous, fixed covariate of baseline score.|Week 13, Week 25|All participants randomized under protocol amendment c,d,e, and have a baseline observation and at least one post-randomization observation.||probability of remission||Standard Error|Least Squares Mean
732996|NCT00406848|Secondary|Change From Baseline in the Quality of Life, Enjoyment, and Satisfaction Questionnaire (Q-LES-Q-SF)|The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF) measures the degree of enjoyment and satisfaction experienced in various areas of daily life. The short version is a self-administered 16 item scale evaluating satisfaction of general activities on a 5-point Likert scale that indicates the degree of enjoyment or satisfaction achieved during the past week (1 = very poor and 5 = very good).|baseline (Week 1), Week 13, Week 25|All participants randomized under protocol amendment c,d,e, and have a baseline observation and at least one post-randomization observation.||units on a scale||Standard Error|Least Squares Mean
732997|NCT00406848|Secondary|Change From Baseline in the Mini-Mental State Exam (MMSE)|Mini-Mental State Examination (MMSE)is a widely used rating measure of cognitive ability. Scores range from 0 to 30. The MMSE will be used to categorize patients as with or without dementia. Higher number indicates better cognitive ability. Patients with a MMSE score of 20 to 23 will be categorized as having mild dementia, while those with a score of ≥ 24 will be categorized as having no dementia.|baseline (Week 1), Week 9, Week 25|All participants randomized under protocol amendment c,d,e, and have a baseline observation and at least one post-randomization observation.||units on a scale||Standard Error|Least Squares Mean
732998|NCT00406848|Secondary|Change From Baseline in the Clinical Global Impression-Severity (CGI-S)|Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|baseline (Week 1), Week 13, Week 25|All participants randomized under protocol amendment c,d,e, and have a baseline observation and at least one post-randomization observation.||units on a scale||Standard Error|Least Squares Mean
732999|NCT00406848|Secondary|Patient's Global Impression of Improvement (PGI-I) at 13 Weeks and 25 Weeks|The PGI-Improvement scale is a patient-rated instrument that measures perceived improvement in symptoms. It is a 7-point scale where a score of 1 indicates that the patient is “very much improved,” a score of 4 indicates that the patient has experienced “no change,” and a score of 7 indicates that the patient is “very much worse.”|Week 13, Week 25|All participants randomized under protocol amendment c,d,e, and have at least one post-randomization observation.||units on a scale||Standard Error|Least Squares Mean
733000|NCT00406848|Secondary|Change From Baseline in the Numeric Rating Scales (NRS) for Pain Item Scores|Numeric Rating Scales (Semantic Differential Scales) for Pain are 6 self-administered scales that assesses experience of overall pain, back pain, headache, shoulder pain, time in pain while awake, and pain interference with daily activities, during the past week. Each item is scored on a numeric 11-point semantic differential scale (0-10) from 0 = no pain to 10 = pain as severe as you can imagine; or 0 = none of the time to 10 = all of the time; or 0 = no interference to 10 = unable to do any activities at all.|baseline (Week 1), Week 13, Week 25|All participants randomized under protocol amendment c,d,e, and have a baseline observation and at least one post-randomization observation.||units on a scale||Standard Error|Least Squares Mean
733001|NCT00406848|Secondary|Change From Baseline in the Brief Pain Inventory (BPI) Severity and Interference Scores|The Brief Pain Inventory (severity and interference scales) (BPI) is a self-reported scale that measures the severity of pain and the interference of pain on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life.|baseline (Week 1), Week 13, Week 25|All participants randomized under protocol amendment c,d,e, and have a baseline observation and at least one post-randomization observation.||units on a scale||Standard Error|Least Squares Mean
733014|NCT00407355|Primary|Best Corrected Visual Acuity Change From Baseline at All Visits||continuous through 72 mos|||ETDRS letters||Standard Deviation|Mean
733015|NCT00407381|Primary|Mean Change in Best Corrected Visual Acuity (BCVA) at Month 6|Mean change of best corrected visual acuity letters (BCVA) at month 6|6 months|Mean change in BCVA at month 6||Mean letter change in BCVA||Standard Deviation|Mean
733002|NCT00406848|Secondary|Change From Baseline in the HAMD-17 Total Score, Subscales, and Individual Items|Total Score assess depression severity (scores 0-52). Core, Maier and Bech subscales assess symptoms of depression (scores:0-20=Core; 0-24=Maier; 0-22=Bech). Anxiety/Somatization subscale assesses severity of anxiety (0-18). Retardation subscale assesses dysfunction in mood and work (0-14). Sleep subscale assesses insomnia (0-6). Individual item scores may range from 0-4 or 0-2. Higher numbers indicate more severe symptoms.|baseline (Week 1), Week 13, Week 25|Randomized patients with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
733003|NCT00406848|Secondary|Change From Baseline on the 30-item Geriatric Depression Scale (GDS)|The 30-item Geriatric Depression Scale (GDS) is a self-administered test of 30 questions to measure the severity of depression. The yes/no questions result in a range of scores from 0 (normal) to 30 (severe depression).|baseline (Week 1), Week 13, Week 25|All participants randomized under protocol amendment c,d,e, and have a baseline observation and at least one post-randomization observation.||units on a scale||Standard Error|Least Squares Mean
733004|NCT00406848|Primary|Change From Baseline to 13 Weeks in Hamilton Depression Rating Scale (HAMD-17) Maier Subscale|The Maier subscale (Items 1,2,7,8,9,10) represents symptoms of depression. Total subscale scores range from 0 (normal) to 24 (severe).|baseline (Week 1), Week 13|All participants randomized under protocol amendment c,d,e, and have a baseline observation and at least one post-randomization observation.||units on a scale||Standard Error|Least Squares Mean
733005|NCT00407030|Primary|Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Injection of the Main Period - Xeomin (240 Units) Versus Xeomin (120 Units)|"The TWSTRS-Total score is the sum of scores of the three components of the scale:
TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity)
TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain)
TWSTRS-Disability score which ranges from 0 (=no disability) to 30 (=maximum disability).
The TWSTRS total score ranges from 0 (=best value) to 85 (=worst value). The change from baseline was calculated as the score at the corresponding visit minus the baseline score."|Baseline, week 4|Intention to treat population: all participants randomized were included in the primary efficacy analysis; missing values were imputed using the worst case strategy, i.e. imputation by baseline value||points on a scale||Standard Error|Least Squares Mean
733006|NCT00407030|Primary|Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Injection of the Main Period - Xeomin (120 Units) Versus Placebo|"The TWSTRS-Total score is the sum of scores of the three components of the scale:
TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity)
TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain)
TWSTRS-Disability score which ranges from 0 (=no disability) to 30 (=maximum disability).
The TWSTRS total score ranges from 0 (=best value) to 85 (=worst value). The change from baseline was calculated as the score at the corresponding visit minus the baseline score."|Baseline, week 4|Intention to treat population: all participants randomized were included in the primary efficacy analysis; missing values were imputed using the worst case strategy, i.e. imputation by baseline value||points on a scale||Standard Error|Least Squares Mean
733007|NCT00407030|Secondary|Patient Evaluation of Global Response (PEGR) at Final Visit|"The PEGR is a descriptive subjective 9-point response scale ranging from complete abolishment of signs and symptoms (value=+4) down to very marked worsening (value=-4)."|Final visit (up to 20 weeks after injection of the Main Period)|"Intention to treat population with missing values imputed by no effect"||points on a scale||Standard Deviation|Mean
733008|NCT00407030|Secondary|Change From Baseline in the TWSTRS Pain Subscore|TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.|Baseline, week 4, week 8, final visit (up to 20 weeks after injection of the Main Period)|Intention to treat population with missing values imputed using the worst case strategy, i.e. imputation by baseline value||points on a scale||Standard Deviation|Mean
733009|NCT00407030|Secondary|Change From Baseline in the TWSTRS Severity Subscore|TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.|Baseline, week 4, week 8, final visit (up to 20 weeks after injection of the Main Period)|Intention to treat population with missing values imputed using the worst case strategy, i.e. imputation by baseline value||points on a scale||Standard Deviation|Mean
733010|NCT00407030|Secondary|Change From Baseline in the TWSTRS Disability Subscore|TWSTRS-Disability score which ranges from 0 (=no disability)to 30 (=maximum disability). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.|Baseline, week 4, week 8, final visit (up to 20 weeks after injection of the Main Period)|Intention to treat population with missing values imputed using the worst case strategy, i.e. imputation by baseline value||points on a scale||Standard Deviation|Mean
733011|NCT00407030|Secondary|Change From Baseline in the TWSTRS-Total Score|"The TWSTRS-Total score is the sum of scores of the three components of the scale:
TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity)
TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain)
TWSTRS-Disability score which ranges from 0 (=no disability) to 30 (=maximum disability).
The TWSTRS total score ranges from 0 (=best value) to 85 (=worst value). The change from baseline was calculated as the score at the corresponding visit minus the baseline score."|Baseline, week 8, final visit (up to 20 weeks after injection of the Main Period)|Intention to treat population with missing values imputed using the worst case strategy, i.e. imputation by baseline value||points on a scale||Standard Deviation|Mean
733012|NCT00407030|Primary|Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Injection of the Main Period - Xeomin (240 Units) Versus Placebo|"The TWSTRS-Total score is the sum of scores of the three components of the scale:
TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity)
TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain)
TWSTRS-Disability score which ranges from 0 (=no disability) to 30 (=maximum disability).
The TWSTRS total score ranges from 0 (=best value) to 85 (=worst value). The change from baseline was calculated as the score at the corresponding visit minus the baseline score."|Baseline, week 4|Intention to treat population: all participants randomized were included in the primary efficacy analysis; missing values were imputed using the worst case strategy, i.e. imputation by baseline value||points on a scale||Standard Error|Least Squares Mean
733016|NCT00407485|Primary|Progression-free Survival (PFS)|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions PFS using the product-limit method of Kaplan and Meier.|From start of treatment to time of progression, assessed up to 4 months|||Months||95% Confidence Interval|Median
733017|NCT00407485|Primary|Tumor Response Rate|"Response rate (RR) and progression free survival (PFS) were assessed in a 2-stage accrual design (22+18). A maximum of 40 patients were to be accrued to rule out a null hypothesized RR of 4% and PFS of 3 months versus alternative of 15% RR and 5.4 months PFS (corresponding to 4 month PFS of 40% vs 60%) with α=0.12 and β=0.19. If no more than 1 objective response (no more than 4.5%), and no more than 10 instances of 4-month PFS (no more than 45%), were observed among the initial 22 patients, the study would be terminated early and declared negative. Tumor response was evaluated by CT or MRI using RECIST v1.0 criteria.
Responders were confirmed partial or complete responses to treatment."|From the start of the treatment until disease progression or recurrence, assessed up to 4 years|||percentage of responders||95% Confidence Interval|Number
733018|NCT00407511|Secondary|Clinical Global Impression of Change (CGIC)|7-point investigator rating scale of change in participant's status since beginning study medication. Range: 1 (very much improved) to 7 (very much worse).|End of Treatment/ Last Observation Carried Forward (Week 12 or last post-baseline assessment)|Full Analysis Set (FAS)||participants|||Number
733019|NCT00407511|Secondary|Patient Global Impression of Change (PGIC)|7-point participant rating scale for change observed in their overall status since beginning of study medication. Range: 1 (very much improved) to 7 (very much worse)|End of Treatment/ Last Observation Carried Forward (Week 12 or last post-baseline assessment)|Full Analysis Set (FAS)||participants|||Number
733020|NCT00407511|Secondary|Change From Baseline in Mean Daily Sleep Interference Score (DSIS)|Daily sleep interference measured on an 11-point Likert scale. Range: 0 (pain did not interfere with sleep) to 10 (pain completely interfered with sleep). Change = mean at observation minus mean at Baseline. Evaluations recorded in patient's daily sleep diaries.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, EOT/LOCF|Full Analysis Set (FAS); End of Treatment/Last Observation Carried Forward (EOT/LOCF): last post-baseline assessment.||scores on scale||Standard Deviation|Mean
733021|NCT00407511|Secondary|Change From Baseline in Global Anxiety Visual Analogue Scale (GA-VAS)|100-mm line (Visual Analog Scale) marked by the subject to measure their degree of anxiety over past 24 hours. Range: 0 = not at all anxious to 100 = extremely anxious. Change = mean score at observation minus mean score at Baseline.|Baseline, Week 8, Week 12, EOT/LOCF|Full Analysis Set (FAS); End of Treatment/Last Observation Carried Forward (EOT/LOCF): last post-baseline assessment.||scores on scale||Standard Deviation|Mean
733022|NCT00407511|Secondary|Change From Baseline in Visual Analogue Scale for Pain (VAS-pain)|100 mm line (Visual Analog Scale) marked by subject; Intensity of pain range (over past week): 0 = no pain to 100 = worst possible pain. Change = observation mean minus Baseline mean.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12, EOT/LOCF|Full Analysis Set (FAS); End of Treatment/Last Observation Carried Forward (EOT/LOCF): last post-baseline assessment.||scores on scale||Standard Deviation|Mean
733023|NCT00407511|Secondary|Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication|Satisfaction with current pain medication response scale: 0 (worst possible response) to 100 (best possible response). Score=[(5-mean of non-missing items)*100]/4.|Baseline, Week 8, Week 12, EOT/LOCF|Full Analysis Set (FAS); End of Treatment/Last Observation Carried Forward (EOT/LOCF): last post-baseline assessment. Subjects were only included in the Week 8 analysis if their visit fell between Days 49 and 63, and were only included in the Week 12 analysis if their visit was after Day 78.||scores on scale||Standard Deviation|Mean
733024|NCT00407511|Secondary|Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication|Impact of current pain medication response scale: 0 (worst possible response) to 100 (best possible response). Score=[(5-mean of non-missing items)*100]/4.|Baseline, Week 8, Week 12, EOT/LOCF|Full Analysis Set (FAS); End of Treatment/Last Observation Carried Forward (EOT/LOCF): last post-baseline assessment. Subjects were only included in the Week 8 analysis if their visit fell between Days 49 and 63, and were only included in the Week 12 analysis if their visit was after Day 78.||scores on scale||Standard Deviation|Mean
733025|NCT00407511|Secondary|Change From Baseline in Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Interference Index Scores|Self-administered questionnaire: change from Baseline in mean pain interference with functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. 11-point scale from 0 (does not interfere) to 10 (completely interferes). Change = observation mean minus Baseline mean.|Baseline, Week 8, Week 12, End of Treatment/Last Observation Carried Forward (EOT/LOCF)|Full Analysis Set (FAS); End of Treatment/Last Observation Carried Forward (EOT/LOCF): last post-baseline assessment.||scores on scale||Standard Deviation|Mean
733026|NCT00407511|Secondary|Change From Baseline (BL) in Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores|Self-administered questionnaire: change from Baseline in mean pain severity index over past 24 hours; 11-point numeric rating scale ranging from 0 (no pain) to 10 (worst pain possible). Pain severity index is the mean of item scores 2, 3, and 4 (pain right now, worst pain, and average pain level). Change = mean score at observation minus mean score at Baseline.|Baseline, Week 8, Week 12, EOT/LOCF|Full Analysis Set (FAS); End of Treatment/Last Observation Carried Forward (EOT/LOCF): last post-baseline assessment.||scores on scale||Standard Deviation|Mean
733027|NCT00407511|Secondary|Change From Baseline in Mean Pain Score on the Daily Pain Rating Scale (DPRS)|11 point Likert scale; range: 0 to 10 (no pain to worst possible pain) over past 24 hours. Baseline score = mean score of preceding 7 days (including Visit 2). Weekly pain score = mean pain score from last 7 post-Baseline days preceding observation visit or last 7 days on study drug for early termination. Change = mean at observation minus mean at Baseline.|Week 4, Week 8, Week 12|Full Analysis Set (FAS).||scores on scale||Standard Deviation|Mean
733046|NCT00407537|Secondary|Framingham 10-year Risk of Stroke at Month 12|Stroke risk calculated from the Framingham risk for CVD (CHD, stroke, intermittent claudication, congestive heart failure) multiplied by a gender-specific “calibration factor” for the stroke component risk. Coefficients were used to derive the score calculated at the end of study treatment (Month 12).|Baseline, Month 12|FAS. Number of participants analyzed refers to number of participants contributing to data.||percent risk||Standard Deviation|Mean
733028|NCT00407511|Primary|Change From Baseline to End of Treatment (EOT) in Weekly Mean Pain Score on the Daily Pain Rating Scale (DPRS)|11 point Likert scale: range 0 to 10 (no pain to worst possible pain) over past 24 hours. Baseline score = mean score of preceding 7 days (including Visit 2). Final end of treatment (EOT) pain score = mean pain score from last 7 post-Baseline days preceding Visit 8 (Week 12) or last 7 days on study drug for those who did not complete the study. Change = mean at EOT minus mean at Baseline.|Baseline, End of Treatment|Full Analysis Set (FAS): patients who took at least one dose of study medication, had a baseline value, and had at least one post-baseline measurement; Last Observation Carried Forward (LOCF).||scores on scale||Standard Deviation|Mean
733029|NCT00407537|Secondary|Number of Participants With Increase of Treatment Dosages After 4 Months.|Treatments indicative of prescribed medications other than study provided Caduet.|Month 4|FAS. Number of participants analyzed refers to number of participants contributing data.||Participants|||Number
733030|NCT00407537|Secondary|Number of Participants With Lipid and Antihypertensive Treatments Used at 4 and 12 Months|Treatments indicative of prescribed medications other than study provided Caduet.|Month 4, Month 12|FAS. Number of participants analyzed refers to number of participants contributing data.||participants|||Number
733031|NCT00407537|Secondary|Percentage of Participants at Conventional Treatment Goals According to Global and Local Guidelines for LDL at 4 and 12 Months|Goal set at <100 mg/dL according to the United States (US) National Cholesterol Education Program Adult Treatment Panel 3 and at <80 mg/dL according to the European (EU) Society of Cardiology guidelines.|Month 4, Month 12|FAS. Number of participants analyzed refers to number of participants contributing data.||Percentage of participants|||Number
733032|NCT00407537|Secondary|Percentage of Participants at Conventional Treatment Goals According to Global and Local Guidelines for Blood Pressure at 4 and 12 Months|Goals set at <140/90 mmHg according to the seventh Joint National Committee (JNC) on prevention, detection, evaluation, and treatment of high blood pressure and <140/90 mm Hg or <130/80 mm Hg for diabetics ccording to the European Society of Cardiology (ESC) guidelines.|Month 4, Month 12|FAS. Number of participants analyzed refers to number of participants contributing data.||percentage of participants|||Number
733033|NCT00407537|Secondary|Change From Baseline in Lipid Parameters at Month 12|Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations.|Baseline, Month 12|FAS. Number of participants analyzed refers to number of participants contributing data.||mg/dL||95% Confidence Interval|Least Squares Mean
733034|NCT00407537|Secondary|Change From Baseline in Lipid Parameters at Month 4|Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations. Change from baseline measured as mean at Month 4 minus mean at Baseline.|Baseline, Month 4|FAS. Number of participants analyzed refers to number of participants contributing data.||mg/dL||95% Confidence Interval|Least Squares Mean
733035|NCT00407537|Secondary|Mean Lipid Parameters at Month 12|Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations.|Month 12|FAS. Number of participants analyzed refers to number of participants contributing data.||mg/dL||Standard Deviation|Mean
733036|NCT00407537|Secondary|Mean Lipid Parameters at Month 4|Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations.|Month 4|FAS. Number of participants analyzed refers to number of participants contributing data.||mg/dL||Standard Deviation|Mean
733037|NCT00407537|Secondary|Change From Baseline in DBP at Month 12||Baseline, Month 12|FAS. Number of participants analyzed refers to number of participants contributing to data.||mmHg||95% Confidence Interval|Least Squares Mean
733038|NCT00407537|Secondary|Change From Baseline in SBP at Month 12||Baseline, Month 12|FAS, number of participants analyzed refers to number of participants contributing to data.||mmHg||95% Confidence Interval|Least Squares Mean
733039|NCT00407537|Secondary|Change From Baseline in Diastolic Blood Pressure (DBP) at Month 4||Baseline, Month 4|FAS. Number of participants analyzed refers to number of participants contributing to data.||mmHG||95% Confidence Interval|Least Squares Mean
733040|NCT00407537|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) at Month 4||Baseline, Month 4|FAS. Number of participants analyzed refers to number of participants contributing to data.||mmHG||95% Confidence Interval|Least Squares Mean
733041|NCT00407537|Secondary|Mean Systolic and Diastolic Blood Pressure at Month 12||Month 12|FAS. Number of participants analyzed refers to number of participants contributing to data.||mmHg||Standard Deviation|Mean
733042|NCT00407537|Secondary|Mean Systolic and Diastolic Blood Pressure at Month 4||Month 4|FAS. Number of participants analyzed refers to number of participants contributing data.||mmHg||Standard Deviation|Mean
733043|NCT00407537|Secondary|Change From Baseline European SCORE 10-year Risk of Developing Fatal CVD|European SCORE: designed to measure cardiovascular disease mortality; computed using age, gender, whether a person lives in a low risk or high risk region, measured total cholesterol, measured HDL cholesterol, systolic blood pressure, and current smoking status. Change from baseline calculated as mean at observation minus mean at Baseline.|Baseline, Month 4, Month 12|FAS. Number of participants analyzed refers to number of participants contributing to data.||percent risk||95% Confidence Interval|Least Squares Mean
733044|NCT00407537|Secondary|Change From Baseline in Framingham 10-year Risk of Developing Total CHD|Framingham prediction of 10-year risk of CHD: Gender-specific prediction equations formulated to predict CHD risk according to age, diabetes, smoking, blood pressure categories, and total cholesterol and low density lipoprotein (LDL) cholesterol categories. Change from baseline calculated as mean at observation minus mean at Baseline.|Baseline, Month 4, Month 12|FAS. Number of participants analyzed refers to number of participants contributing to data.||percent risk||95% Confidence Interval|Least Squares Mean
733045|NCT00407537|Secondary|Framingham 10-year Risk of Stroke at Month 4|Stroke risk calculated from the Framingham risk for CVD (CHD, stroke, intermittent claudication, congestive heart failure) multiplied by a gender-specific “calibration factor” for the stroke component risk. Coefficients were used to derive the score calculated at the end of study treatment (Month 12).|Baseline, Month 4|FAS. Number of participants analyzed refers to number of participants contributing to data.||percent risk||Standard Deviation|Mean
733061|NCT00407654|Secondary|Overall Survival (Bevacizumab-treated Group)|Kaplan-Meier method will be used (Bevacizumab-treated Group)|12 months|||months||95% Confidence Interval|Median
733062|NCT00407654|Secondary|Overall Survival (Bevacizumab-treated Group)|Kaplan-Meier method will be used. (Bevacizumab-treated Group)|6 months|||months||95% Confidence Interval|Median
733047|NCT00407537|Secondary|European SCORE 10-year Risk of Fatal CVD at Month 4|European SCORE: designed to measure cardiovascular disease mortality; computed using age, gender, whether a person lives in a low risk or high risk region, measured total cholesterol, measured HDL cholesterol, systolic blood pressure, and current smoking status. The coefficients were used to derive the score calculated after 4 months of study treatment (Month 4).|Baseline, Month 4|FAS. Number of participants analyzed refers to number of participants contributing to data.||percent risk||Standard Deviation|Mean
733048|NCT00407537|Secondary|European Systematic COronary Risk Evaluation (SCORE) 10-year Risk of Fatal Cardiovascular Disease (CVD) at Month 12|European SCORE: designed to measure cardiovascular disease mortality; computed using age, gender, whether a person lives in a low risk or high risk region, measured total cholesterol, measured HDL cholesterol, systolic blood pressure, and current smoking status. The coefficients were used to derive the score calculated after 12 months of study treatment (Month 12).|Baseline, Month 12|FAS. Number of participants analyzed refers to number of participants contributing to data.||percent risk||Standard Deviation|Mean
733049|NCT00407537|Secondary|Framingham 10-year Risk of Total CHD at Month 4|Framingham prediction of 10-year risk of CHD: Gender-specific prediction equations formulated to predict CHD risk according to age, diabetes, smoking, blood pressure categories, and total cholesterol and low density lipoprotein (LDL) cholesterol categories. The coefficients were used to derive the score calculated after 4 months of treatment (Month 4).|Baseline, Month 4|FAS. Number of participants analyzed refers to number of participants contributing to data.||percent risk||Standard Deviation|Mean
733050|NCT00407537|Primary|Framingham 10-year Risk of Total Coronary Heart Disease (CHD) at Month 12|Framingham prediction of 10-year risk of CHD: Gender-specific prediction equations formulated to predict CHD risk according to age, diabetes, smoking, blood pressure categories, and total cholesterol and low density lipoprotein (LDL) cholesterol categories. The coefficients were used to derive the score calculated at the end of study treatment (Month 12).|Baseline, Month 12|Full Analysis Set (FAS) included all subjects, in either treatment group, who had blood pressure and lipid data from at least 1 follow-up visit. Number of participants analyzed refers to number of participants contributing to data.||percent risk||Standard Deviation|Mean
733051|NCT00407550|Secondary|Adverse Event|Number of patients that experienced adverse events (grade 4 or more) as measured by NCI CTCAE (Common Terminology Criteria for Adverse Events) v3.0|Gemzar x2 Arm every 21 days, Gemzar x1 Arm every 14 days (up to 2 years)||||||
733052|NCT00407550|Secondary|Overall Survival|Overall survival time was defined as the number of months from registration to the date of death or last follow-up|Death or last follow-up (up to 2 years)||||||
733053|NCT00407550|Secondary|Progression-free Survival|Progression-free survival was defined as the number of months from registration to the date of disease progression or death, with patients who are alive and progression free being censored on the date of their last evaluation.|Time from registration to progression or death (up to 2 years)||||||
733054|NCT00407550|Primary|Number of Patients With Confirmed Responses|"Confirmed tumor response (complete and partial) as measured by RECIST(Response Evaluation Criteria In Solid Tumors) criteria on 2 consecutive evaluations at least 6 weeks apart.
>
> Confirmed tumor response is at least a 30% decrease in the sum of the longest diameter of target lesions and no new lesions."|Two consecutive evaluations at least 6 weeks apart (up to 2 years)|||participants|||Number
733055|NCT00407563|Secondary|Best Overall Response at Six Months|The outcome measure assessed the percentage of participants who had achieved either a Partial or Complete Response over 6 months of treatment. Radiologic imaging was scheduled to be performed at baseline, after every third treatment cycle, and at the end of treatment or time of progression unless it was done in the previous four weeks. Response was evaluated using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is >=30% decrease in the sum of the longest diameter of target lesions; overall response (OR) = CR+PR.|Assessed over 6 months of study treatment|The 2 tailed, 95% confidence interval of the estimated response rate was calculated using the normal approximation to the binomial distribution.||percentage of patients||95% Confidence Interval|Number
733056|NCT00407563|Secondary|Progression-free Survival (PFS)|Disease progression was determined through radiology imaging measurements and by clinical or symptomatic progression during or after treatment. Progression is defined per RECIST criteria v1.0 as a measurable increase in the smallest diameter of any target lesion, progression of existing non-target lesions, or the appearance of 1 or more new lesions.|PFS was measured from day 1 of treatment until time of progression (assessed every 12 weeks) or death, whichever came first, assessed up to 30 months.|Participants who had not experienced either disease progression or death during or after stopping treatment were censored in the analysis.||Months||95% Confidence Interval|Median
733057|NCT00407563|Secondary|Overall Survival||Overall survival is defined as the time from treatment start until death from any cause, assessed up to 40 months.|Participants who had not experienced death during or after stopping treatment were censored in the analysis.||Months||95% Confidence Interval|Median
733058|NCT00407563|Secondary|Best Overall Response|Radiologic imaging was scheduled to be performed at baseline, after every third treatment cycle, and at the end of treatment or time of progression unless it was done in the previous four weeks. Response was evaluated using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is >=30% decrease in the sum of the longest diameter of target lesions; overall response (OR) = CR+PR.|Radiologic imaging was repeated after every 3 cycles (about every 12 weeks) during study treatment, up to 31 months.|||Participants|||Number
733059|NCT00407563|Primary|6-month Progression-Free Rate|Progression-free rate is defined as the percentage of participants with no progression event at 6 months after starting study treatment. An event for this endpoint was defined as a progression-free survival event occurring earlier than six months, or discontinuation of treatment earlier than six months for any other reason. Progression is defined per RECIST criteria v1.0 as a measurable increase in the smallest diameter of any target lesion, progression of existing non-target lesions, or the appearance of 1 or more new lesions.|6 months after initiation of study treatment|||percentage of patients||95% Confidence Interval|Number
733060|NCT00407654|Secondary|Number of Participants With Response (Bevacizumab-treated Group)|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions; Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD;
Stable disease for atleast 16 weeks"|Up to 6 years|||participants|||Number
733063|NCT00407654|Primary|Progression-free Survival (Bevacizumab-treated Group)|"Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Kaplan-Meier method will be used. Progression-free survival (Bevacizumab-treated group)"|4 months|||months||95% Confidence Interval|Median
733064|NCT00407654|Secondary|Number of Participants With Response (Bevacizumab-naïve Group)|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions; Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD;
Stable disease for atleast 16 weeks"|Up to 6 years|||participants|||Number
733065|NCT00407654|Secondary|Objective Stable Disease Rate||Up to 6 years||||||
733066|NCT00407654|Secondary|Time to Progression|Kaplan-Meier method will be used.|12 months||||||
733067|NCT00407654|Secondary|Overall Survival (Prior Bevacizumab Treated Group)|Kaplan-Meier method will be used (Bevacizumab-naïve Group)|12 months|||months||95% Confidence Interval|Median
733068|NCT00407654|Secondary|Overall Survival (Bevacizumab-naïve Group)|Kaplan-Meier method will be used. (Bevacizumab- naïve Group)|12 months|||months||95% Confidence Interval|Median
733069|NCT00407654|Primary|Progression-free Survival (Bevacizumab- naïve Group)|"Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Kaplan-Meier method will be used.Progression-free survival (Bevacizumab- naïve group)"|4 months|||months||95% Confidence Interval|Median
733070|NCT00407654|Primary|Objective Tumor Response (Defined as Partial or Complete Response as Defined by the RECIST Criteria)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions:Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions|Up to 6 years|||participants|||Number
733071|NCT00407745|Secondary|Change From Baseline in Hospital and Anxiety Depression Scale (HADS) - Depression|HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis||score on scale||Standard Deviation|Mean
733072|NCT00407745|Secondary|Change From Baseline in Hospital and Anxiety Depression Scale (HADS) - Anxiety|HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis||score on scale||Standard Deviation|Mean
733073|NCT00407745|Secondary|Number of Participants Having Optimal Sleep Based on Medical Outcomes Study Sleep Scale (MOS-SS)|Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.|Baseline, Week 16|mITT; LOCF; (N) = number of participants with data available for analysis||participants|||Number
733074|NCT00407745|Secondary|Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Somnolence|Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis||score on scale||Standard Deviation|Mean
733075|NCT00407745|Secondary|Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Quantity|Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis||score on scale||Standard Deviation|Mean
733076|NCT00407745|Secondary|Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Awaken Short of Breath or With a Headache|Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis||score on scale||Standard Deviation|Mean
733100|NCT00407745|Secondary|Change From Baseline in Weekly Mean Sleep Interference Score|Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]).|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis||score on scale||Standard Deviation|Mean
733077|NCT00407745|Secondary|Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Snoring|Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis||score on scale||Standard Deviation|Mean
733078|NCT00407745|Secondary|Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Adequacy|Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis||score on scale||Standard Deviation|Mean
733079|NCT00407745|Secondary|Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Disturbance|Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis||score on scale||Standard Deviation|Mean
733080|NCT00407745|Secondary|Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS)- 9-Item Overall Sleep Problems Index|Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis||score on scale||Standard Deviation|Mean
733081|NCT00407745|Secondary|Number of Participants With Improvement in the Number of Attacks Based on NPSI - Number of Attacks (Item 7)|NPSI – Temporal item which assesses the paroxysmal pain (number of pain attacks during the last 24 hours). Improvement in the number of attacks would be a decrease in the number of paroxysms during the last 24 hours compared to baseline.|Baseline, Week 16|MITT; LOCF; (N) = number of participants with data available for analysis||participants|||Number
733082|NCT00407745|Secondary|Number of Participants With Improved Duration of Brief Pain Attacks Based on NPSI - Duration (Item 4)|NPSI – Temporal item which assesses the duration (number of hours during the last 24 hours) of spontaneous ongoing pain. Improved duration would be a decrease in the number of hours of spontaneous ongoing pain during the last 24 hours compared to baseline.|Baseline, Week 16|MITT; LOCF; (N) = number of participants with data available for analysis||participants|||Number
733083|NCT00407745|Secondary|Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Individual Item (1, 2, 3, 5, 6, 8, 9, 10, 11, 12) Score|Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis||score on scale||Standard Deviation|Mean
733084|NCT00407745|Secondary|Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Paresthesia/Dysesthesia|Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis||score on scale||Standard Deviation|Mean
733085|NCT00407745|Secondary|Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Evoked Pain|Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis||score on scale||Standard Deviation|Mean
733086|NCT00407745|Secondary|Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Paroxysmal Pain|Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis||score on scale||Standard Deviation|Mean
733087|NCT00407745|Secondary|Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Pressing Spontaneous Pain|Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis||score on scale||Standard Deviation|Mean
733088|NCT00407745|Secondary|Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Burning Spontaneous Pain|Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.|Baseline, Week 16|mITT; LOCF;(n) = number of participants with data available for analysis||score on scale||Standard Deviation|Mean
733089|NCT00407745|Secondary|Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - 12 Items Total Intensity Score|Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis||score on scale||Standard Deviation|Mean
733090|NCT00407745|Secondary|Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Cold Hyperalgesia Subscales|Participant rated pain scale. The pain produced by the applied stimulus (Cold hyperalgesia - touch with cold metal rod 4 degrees celsius) was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain).|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis||score on scale||Standard Deviation|Mean
733091|NCT00407745|Secondary|Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Cold Allodynia|Participant rated pain scale. The pain produced by the applied stimulus (Cold allodynia - touch with cool metal rod 13-17 degrees celsius was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain).|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis||score on scale||Standard Deviation|Mean
733092|NCT00407745|Secondary|Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Temporal Summation to Tactile Stimuli|Participant rated pain scale. The pain produced by the applied stimulus (Temporal summation to tactile stimuli - repeated touching/tapping) was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain).|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis||score on scale||Standard Deviation|Mean
733093|NCT00407745|Secondary|Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Punctata Hyperalgesia|Participant rated pain scale. The pain produced by the applied stimulus (Punctata hyperalgesia - pinprick) was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain).|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis||score on scale||Standard Deviation|Mean
733094|NCT00407745|Secondary|Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP) - Dynamic Mechanical Allodynia|Participant rated pain scale. The pain produced by the applied stimulus (dynamic mechanical allodynia - gentle stroking with foam brush) was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain).|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis||score on scale||Standard Deviation|Mean
733095|NCT00407745|Secondary|Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP) - Static Mechanical Allodynia|Participant rated pain scale. The pain produced by the applied stimulus (static mechanical allodynia - gentle constant mechanical pressure) was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain).|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis||score on scale||Standard Deviation|Mean
733096|NCT00407745|Secondary|Change From Baseline in Modified Brief Pain Inventory Interference Scale (10-Item) (mBPI-10) Total Score|The Modified Brief Pain Inventory (mBPI-10) Interference Scale is a self administered questionnaire that assessed pain interference with functional activities over the past week. The items were measured on an 11 point scale, ranging from “does not interfere” (0) to “completely interferes” (10). A composite score, the pain interference index, was calculated by averaging the 10 items that comprised the scale.|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis||score on scale||Standard Deviation|Mean
733097|NCT00407745|Other Pre-specified|Change From Baseline in Weekly Mean Sleep Interference Score by Week|Pain related sleep interference was assessed on an 11 point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]).|Baseline, Week 1 through 16|ITT; (n) = number of participants with data available for analysis||score on scale||Standard Deviation|Mean
733098|NCT00407745|Secondary|Number of Participants With >=50% Reduction in Weekly Mean Pain Score From Baseline|Mean weekly score was calculated as the average of the available daily diary pain score values for the week. Pain score was measured on an 11-point numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain).|Baseline, Week 16|mITT; LOCF; (N) = number of participants with data available for analysis||participants|||Number
733099|NCT00407745|Secondary|Change From Baseline in Weekly Mean Pain Score by Week|Mean weekly score was calculated as the average of the available daily diary pain score values for the week. Pain score was measured on an 11-point numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain).|Baseline, Week 1 through16|ITT population: defined as all randomized participants who took at least one dose of study medication. (This population included the 8 participants who were randomized before the protocol amendment 2). (n) = number of participants with data for analysis.||score on scale||Standard Deviation|Mean
733101|NCT00407745|Secondary|Number of Participants With Categorical Scores on the Patient Global Impression of Change (PGIC) (Full Scale)|The PGIC is a participant-rated instrument measuring change in the participant’s overall status on a 7-point scale: 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse.|Baseline, Week 16|mITT; LOCF; (N) = number of participants with data available for analysis||participants|||Number
733102|NCT00407745|Secondary|Number of Participants With >=30% Reduction in Weekly Mean Pain Score From Baseline|Mean weekly score was calculated as the average of the available daily diary pain score values for the week. Pain score was measured on an 11-point numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain).|Baseline, Week 16|mITT; LOCF: LOCF Endpoint corresponded to the last 7 days of diary data up to and including Week 16 and applied if the Week 16 assessment was missing; (N) = number of participants that can be analyzed for the endpoint.||participants|||Number
733103|NCT00407745|Secondary|Change From Baseline in Weekly Mean Pain Score|Mean weekly score was calculated as the average of the available daily diary pain score values for the week. Pain score was measured on an 11-point numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain).|Baseline, Week 16|mITT; modified baseline observation carried forward (mBOCF) imputation: mBOCF mean pain score was defined as the baseline mean pain score for participants who discontinued double-blind treatment due to adverse event or who had no postbaseline observations and as the last observation carried forward (LOCF) mean pain score for all other participants.||score on scale||Standard Deviation|Mean
733104|NCT00407745|Primary|Duration Adjusted Average Change (DAAC) of Mean Pain Score|DAAC was derived from participant's daily pain diary, where pain was measured on an 11-point Numerical Rating Scale (NRS-Pain)ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]). The DAAC was calculated as the mean of all daily pain diary rating post baseline minus the baseline score then multiplied by the proportion of the planned study duration completed by the participant.|Baseline, Week 16|mITT: all randomized participants who received at least one dose of study medication except the 8 participants who were randomized before protocol amendment 2.||score on scale||Standard Error|Least Squares Mean
733105|NCT00413478|Primary|Tumor Response Rate (Complete, Partial) of Azacytidine|Overall response rate includes percentage of participants with complete response (CR) plus partial response (PR) responses using the National Cancer Institute (NCI) International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria for response: Complete response defined as no palpable lymph nodes, liver or spleen and absence of symptoms. Neutrophil count > 15,00/Mic L, and platelet count more than 100,000/MicL. Hemoglobin should be > 11g/dl without transfusions. Lymphocyte count <4000/micL. On bone marrow aspirate lymphocyte % should be <30%, and biopsy showing no lymphocyte infiltrate. A partial response was defined as more than or equal to 50% decrease in lymph nodes and liver and spleen size. Neutrophils > 1500/ micL or >50 % improvement from baseline, platelet count >100,000/micL or >50 % improvement from baseline. Hemoglobin >11g/dl or >50% improvement from baseline. A reduction of >50% in Leukocyte count or <30 % lymphocytes with residual disease on biopsy for nodular PR.|3 to 8 weeks treatment cycles, continuation up to 1 year|||percentage of participants|||Number
733106|NCT00413582|Secondary|Time in the Operating Room||1 week|||hours||Standard Deviation|Mean
733107|NCT00413582|Primary|Length of Hospitalization||1 week|||days||Standard Deviation|Mean
733108|NCT00413634|Secondary|Diastolic Blood Pressure|Diastolic blood pressures in patients with ET receiving Agrylin|over 1 day|Safety population||mmHg||Standard Deviation|Mean
733109|NCT00413634|Secondary|Systolic Blood Pressure|Systolic blood pressures in patients with ET receiving Agrylin|over 1 day|Safety population||mmHg||Standard Deviation|Mean
733110|NCT00413634|Primary|Vz/F of Active Metabolite||over 1 day|PK population||L||Standard Deviation|Geometric Mean
733111|NCT00413634|Primary|CL/F of Active Metabolite||over 1 day|PK population||L/h||Standard Deviation|Geometric Mean
733112|NCT00413634|Primary|T 1/2 of Active Metabolite||over 1 day|PK population||hours||Standard Deviation|Geometric Mean
733113|NCT00413634|Primary|AUC of Active Metabolite||over 1 day|PK population||ng.h/ml||Standard Deviation|Geometric Mean
733114|NCT00413634|Primary|Tmax of Active Metabolite||over 1 day|PK population||hours||Standard Deviation|Geometric Mean
733115|NCT00413634|Primary|Cmax of Active Metabolite|An active metabolite has therapeutic activity similar to the parent compound and must be considered in therapeutic pharmacokinetics.|over 1 day|PK population||ng/ml||Standard Deviation|Geometric Mean
733116|NCT00413634|Primary|Volume of Distribution (Vz/F) of Agrylin||over 1 day|PK population||L||Standard Deviation|Geometric Mean
733117|NCT00413634|Primary|Total Clearance (CL/F) of Agrylin||over 1 day|PK population||L/h||Standard Deviation|Geometric Mean
733118|NCT00413634|Primary|Terminal Half-life (T 1/2) of Agrylin||over 1 day|PK population||hours||Standard Deviation|Geometric Mean
733119|NCT00413634|Primary|Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Agrylin||over 1 day|PK population||ng.h/ml||Standard Deviation|Geometric Mean
733120|NCT00413634|Primary|Time of Maximum Plasma Concentration (Tmax) of Agrylin||over 1 day|PK population||hours||Standard Deviation|Geometric Mean
733121|NCT00413634|Secondary|Heart Rate|Heart rates in patients with ET receiving Agrylin|over 1 day|Safety population||beats/min||Standard Deviation|Mean
733122|NCT00413634|Secondary|Platelet Count|Platelet counts in patients with ET receiving Agrylin|over 1 day|Safety population (defined as all patients who received study treatment)||x 1,000,000,000/L||Standard Deviation|Mean
733123|NCT00413634|Primary|Maximum Plasma Concentration (Cmax) of Agrylin||over 1 day|PK population (defined as all patients with post-dose drug concentration data)||ng/ml||Standard Deviation|Geometric Mean
733131|NCT00413660|Secondary|36-Item Short-Form Health Survey (SF-36)|SF-36 is a standardized survey evaluating 8 domains (of 2 components [C]; physical [Ph] and mental [Mn]) of functional health and well being: physical and social (So) functioning (Fn), physical and emotional role (role-physical [R-P], role-emotional [R-E]) limitations, bodily pain (BP), general health (GH), vitality (Vit), mental health (MnH). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline, Week 12, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."||units on a scale||Standard Deviation|Mean
733124|NCT00413660|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Week 2, 12 and 24/ET|FACIT-FS is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-FS score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.|Baseline, Week 2, 12, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."||units on a scale||Standard Deviation|Mean
733125|NCT00413660|Secondary|Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale|FACIT-Fatigue scale (FS) is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-FS score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.|Baseline, Week 2, 12, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."||units on a scale||Standard Deviation|Mean
733126|NCT00413660|Secondary|Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET|Participant-rated questionnaire to assess key constructs of sleep over the past week. Consists of a 12-item based on 7 subscales: sleep disturbance (SD), snoring (Sno), awakened short of breath (ASOB) or with headache, sleep adequacy (Ade), and somnolence (Som) (range: 0-100); sleep quantity (Qua) (range: 0-24), and optimal (Opt) sleep (yes: 1, no: 0) and 9 item index measures of sleep disturbance were constructed to provide 2 composite scores: sleep problem summary (SPS) and overall sleep problems (OSP). Except sleep adequacy, optimal sleep and quantity, higher scores=greater impairment. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range*100); total score range: 0 to 100; higher score = greater intensity of attribute.|Baseline, Week 2, 12, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."||units on a scale||Standard Deviation|Mean
733127|NCT00413660|Secondary|Medical Outcome Study- Sleep Scale (MOS-SS)|Participant-rated questionnaire to assess key constructs of sleep over the past week. Consists of a 12-item based on 7 subscales: sleep disturbance (SD), snoring (Sno), awakened short of breath (ASOB) or with headache, sleep adequacy (Ade), and somnolence (Som) (range:0-100); sleep quantity (Qua)(range:0-24), and optimal (Opt) sleep (yes: 1, no: 0)and nine item index measures of sleep disturbance were constructed to provide composite scores: sleep problem summary (SPS) and overall sleep problems (OSP). Except sleep adequacy, optimal sleep and quantity, higher scores=greater impairment. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute.|Baseline, Week 2, 12, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."||units on a scale||Standard Deviation|Mean
733128|NCT00413660|Secondary|Change From Baseline in Euro Quality of Life-5 Dimentions (EQ-5D) - Health State Profile Utility at Week 12 and 24/ET|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Week 12, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."||units on a scale||Standard Deviation|Mean
733129|NCT00413660|Secondary|Euro Quality of Life-5 Dimentions (EQ-5D) - Health State Profile Utility Score|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Week 12, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."||units on a scale||Standard Deviation|Mean
733130|NCT00413660|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24/ET|SF-36 is a standardized survey evaluating 8 domains (of 2 components [C]; physical [Ph] and mental [Mn]) of functional health and well being: physical and social (So) functioning (Fn), physical and emotional role (role-physical [R-P], role-emotional [R-E]) limitations, bodily pain (BP), general health (GH), vitality (Vit), mental health (MnH). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline, Week 12, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."||units on a scale||Standard Deviation|Mean
733132|NCT00413660|Secondary|Percentage of Participants With Disease Remission Based on DAS28-3 (CRP)|DAS28-3 (CRP) defined remission was classified as a score of <2.6.|Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."||percentage of participants|||Number
733133|NCT00413660|Secondary|Percentage of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)|Disease improvement was classified as good, moderate, and none based on improvement in DAS 28-3 (CRP) from baseline and present DAS 28-3 (CRP) score. Good: an improvement from baseline of >1.2 and a present score of <=3.2; none: an improvement of <=0.6 or >0.6 to <=1.2 with a present score of >5.1; remaining participants were classified as having moderate (Mod) improvement. Scores of good and moderate were considered to have therapeutic response.|Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."||percentage of participants|||Number
733134|NCT00413660|Secondary|Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET|DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission.|Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."||units on a scale||Standard Deviation|Mean
733135|NCT00413660|Secondary|Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])|DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) less than or equal to (<=) 3.2 implied low disease activity and more than (>) 3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) less than (<) 2.6 = remission.|Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."||units on a scale||Standard Deviation|Mean
733136|NCT00413660|Secondary|Change From Baseline in C-Reactive Protein (CRP) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultra-sensitive assay. Normal range of CRP is 0 mg/dL to 10 mg/dL. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."||mg/dL||Standard Deviation|Mean
733137|NCT00413660|Secondary|C-Reactive Protein (CRP)|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is 0 milligram per deciliter (mg/dL) to 10 mg/dL. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."||mg/dL||Standard Deviation|Mean
733138|NCT00413660|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Change = scores at observation minus score at Baseline, and total possible score ranged from -3 to 3. A negative value in change from baseline indicates an improvement.|Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."||units on a scale||Standard Deviation|Mean
733139|NCT00413660|Secondary|Health Assessment Questionnaire-Disability Index (HAQ-DI)|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."||units on a scale||Standard Deviation|Mean
733140|NCT00413660|Secondary|Change From Baseline in Physician Global Assessment of Arthritis at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET|Physician global assessment of arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.|Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."||mm||Standard Deviation|Mean
733141|NCT00413660|Secondary|Physician Global Assessment of Arthritis|Physician global assessment of arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.|Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."||mm||Standard Deviation|Mean
733142|NCT00413660|Secondary|Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly."|Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."||mm||Standard Deviation|Mean
733143|NCT00413660|Secondary|Patient Global Assessment (PtGA) of Arthritis|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly."|Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."||mm||Standard Deviation|Mean
733144|NCT00413660|Secondary|Change From Baseline in Patient Assessment of Arthritis Pain at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET|Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.|Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."||mm||Standard Deviation|Mean
733145|NCT00413660|Secondary|Patient Assessment of Arthritis Pain|Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.|Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."||mm||Standard Deviation|Mean
733146|NCT00413660|Secondary|Change From Baseline in Swollen Joints Count (SJC) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET|Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1. A negative value in change from baseline indicates an improvement.|Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."||swollen joints||Standard Deviation|Mean
733147|NCT00413660|Secondary|Swollen Joints Count (SJC)|Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1.|Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."||swollen joints||Standard Deviation|Mean
733148|NCT00413660|Secondary|Change From Baseline in Tender Joints Count (TJC) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET|Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1. A negative value in change from baseline indicates an improvement.|Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."||tender joints||Standard Deviation|Mean
733149|NCT00413660|Secondary|Tender Joints Count (TJC)|Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.|Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."||tender joints||Standard Deviation|Mean
733150|NCT00413660|Secondary|Area Under the Numeric Index of American College of Rheumatology Response (ACR-n) Curve|ACR-n: calculated for each participant by taking the lowest percentage improvement in (1) SJC or (2) TJC or (3) the median of the remaining 5 components of the ACR response (participant’s assessment of disease activity; participant’s global assessment of pain; physician’s assessment of disease activity; participant’s assessment of physical function; an acute phase reactant value - CRP). Negative numbers indicate worsening. The area under the curve (AUC) for ACR-n is the measure of the area under the curve of the mean change from baseline in ACR-n. The trapezoidal rule was used to compute the AUC.|Baseline up to Week 2, 4, 6, 8, 12|FAS included all randomized participants who received at least 1 dose of study treatment. Missing values were imputed using Last Observation Carried Forward (LOCF).||units on a scale||Standard Deviation|Mean
733207|NCT00414908|Secondary|Change of Stool Frequency Between Baseline and End of Double-blind (DB) Period|Stool frequency is the average of the daily number of stools recorded during the treatment period. Lower values indicate a better response. Change was calculated as (DB stool frequency - Baseline Stool frequency).|End of double-period (5-7 days)|The analysis was done on the Full Analysis sample. Full Analysis Population consists of all subjects who were allocated to the treatment and had data for at least one post-baseline assessment of any efficacy measurement.||Number||Standard Error|Least Squares Mean
733151|NCT00413660|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response|ACR70 response: >= 70% improvement in TJC or SJC and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 2, 4, 6, 8, 12, 16, 20, 24/ET|FAS included all randomized participants who received at least 1 dose of study treatment. Missing values were imputed using BOCF. Here “n” is number of participants evaluable at specific time points for each arm group, respectively.||percentage of participants|||Number
733152|NCT00413660|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response|ACR50 response: >= 50% improvement in TJC or SJC and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 2, 4, 6, 8, 12, 16, 20, 24/ET|FAS included all randomized participants who received at least 1 dose of study treatment. Missing values were imputed using BOCF. Here “n” is number of participants evaluable at specific time points for each arm group, respectively.||percentage of participants|||Number
733153|NCT00413660|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response|ACR20 response: >= 20% improvement in TJC; >= 20% improvement in SJC; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 2, 4, 6, 8, 16, 20, 24/Early Termination (ET)|FAS included all randomized participants who received at least 1 dose of study treatment. Missing values were imputed using BOCF. Here “n” is number of participants evaluable at specific time points for each arm group, respectively.||percentage of participants|||Number
733154|NCT00413660|Primary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12|ACR20 response: >= 20% improvement in tender joints count (TJC); >= 20% improvement in swollen joints count (SJC); and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Week 12|Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study treatment. Missing values were imputed using Baseline Observation Carried Forward (BOCF).||percentage of participants|||Number
733155|NCT00414518|Primary|Viral Set Point|set point is reached after the immune system has developed HIV antibodies and begins to attempt to fight the virus|Throughout study|||Log 10 copies virus/ml||Standard Deviation|Mean
733156|NCT00414518|Primary|Number of Participants Experiencing Either an AIDS-defining Event, a Grade 3 or 4 Adverse Event, or Acute Retroviral Syndrome||At Week 24|||participants|||Number
733157|NCT00414518|Primary|Plasma HIV-1 Viral Load (Copies/ml) at Week 24 as Compared Between the Two Arms||At Week 24|||Log 10 copies of virus/ml||Standard Deviation|Mean
733158|NCT00414544|Secondary|Safety and Effectiveness of CosmetaLife at 3, 9 and 12 Months||3, 9 and 12 months||||||
733159|NCT00414544|Primary|Adverse Event Reporting||6 months||||||
733160|NCT00414544|Primary|Change in Wrinkle Severity Rating Scale|To determine if the mean change in the 5-point Wrinkle Severity Rating Scale (WSRS) score at 6 months was non-inferior to the contralateral Control Restylane treated side, where on this 5-point scale 1 has no measurable nasolabial fold, 2 has some fold, 3 has moderate fold, 4 has heavier moderate fold, and a 5 has deep to a very deep nasolabial fold. For this study only moderate nasolabial folds were included (i.e., 3 or 4), where subjects scored as 5 were excluded.|baseline and 6 months|Analysis was intention to treat (ITT) and each subject received both CosmetaLife and Control (Restylane) injections into contralateral nasolabial folds, respectively. WSRS units (change from baseline analyzed)||units on scale||Standard Deviation|Mean
733161|NCT00414596|Secondary|Number of Patients Who Withdraw From Study.|Total number of patients who withdrew during the 6 weeks of treatment.|6 weeks|||participants|||Number
733162|NCT00414596|Secondary|Number of Adverse Events Following 6 Weeks of DRX9000 Treatment.|Total number of adverse events reported following 6 weeks of DRX9000 treatment.|Six weeks|All subjects enrolled were included in the analysis. No adverse events related to study device were reported.||Number of Adverse Events|||Number
733163|NCT00414596|Secondary|Patient's Satisfaction With Treatment Procedures Following 6 Weeks of DRX9000 Treatment.|Patient's satisfaction with treatment procedures following 6 weeks of DRX9000 treatment was measured on a scale from 0-10 (0= very unsatisfied, 10=very satisfied).|Six weeks|||units on a scale||Inter-Quartile Range|Mean
733164|NCT00414596|Secondary|Change in Functional Capacity From Baseline to Six Weeks (The Revised Oswestry Pain Questionaire)|Subject functional capacity following 6 weeks of DRX9000 treatment will be measured as a numerical score by the Revised Oswestry Pain Questionaire (scale 0-50, 0=pain without effects). Functional capacity was assessed at Baseline, 3 Weeks and 6 Weeks.|Six weeks|||Change in units of scale||Inter-Quartile Range|Median
733165|NCT00414596|Secondary|Recurrence for Significant (VRS Greater Than or Equal to 4) LBP Following Completion of 6 Weeks of DRX9000 Treatment.|The number of Subjects reporting VRS greater than or equal to 4 for LBP following completion of 6 weeks of DRX9000 treatment will be recorded.|Six weeks|||participants|||Number
733166|NCT00414596|Primary|Post-treatment Numerical Pain Intensity Rating Scale (VRS), Which is a Scale From 0-10 (0=no Pain, 10= Worst Pain)|The numerical results of the post-treatment verbal numerical pain intensity rating scale (VRS) following completion of a standard six week series of 20 DRX9000 treatments.|Six weeks|||units on a scale||Inter-Quartile Range|Median
733176|NCT00414609|Secondary|Core Study: Change From Baseline in Left Ventricular End Diastolic Volume (LVEDV)|Change from baseline to end of study in left ventricular end diastolic volume (LVEDV) as measured by echocardiography. (LVEDV) is a measurement of the volume of blood in the heart’s left ventricular chamber at the beginning of the chamber’s filling with blood. This measurement was made by the echocardiography lab. LVEDV values between 67 to 155 mL for men and 56 to 104 mL for women are considered normal. Baseline LVEDV was a covariate.|Baseline and final visit (after 26 to 36 weeks of treatment)|Echocardiogram evaluable set: Patients who had acceptable echocardiogram measurements both at baseline and at post-baseline after receiving at least 26 weeks of treatment.||mL||Standard Error|Least Squares Mean
733167|NCT00414609|Secondary|Extension Study: Percentage of Participants With Specified Criteria in Selected Labs by Laboratory Parameter|"Fasting blood samples were collected throughout the study and were analyzed at a central laboratory. Percentage of participants with the following clinically significant laboratory values are reported:
Potassium <3.5 mmol/L; Low value (Normal reference range: 3.5- 5.3)
Potassium >5.5 mmol/L and Potassium >6.0 mmol/L; High values (Normal reference range: 3.5-5.3)
Creatinine >176.8 μmol/L; High value (Normal reference range= Male: 62- 106 and Female 44- 80)
Blood Urea Nitrogen (BUN) >14.28; High value (Normal reference range: 2.1- 8.9)"|24 Months|"Extension population (considered as Safety population) consisted of all enrolled patients who received at least one dose of study medication in the extension study. n in each of the categories is the number of participants with data available at the given time-point."||Percentage of participants|||Number
733168|NCT00414609|Secondary|Extension Study: Percentage of Participants With Orthostatic Blood Pressure Change|Orthostatic blood pressure change is defined as a decrease of at least 20 mmHg in systolic blood pressure or a decrease of at least 10 mmHg in diastolic blood pressure when a patient moves from a sitting position to a standing position. A patient could show orthostatic blood pressure change at more than one visit. End of study is Month 24 or early discontinuation.|Baseline (Day 0 Extension study), Week 2, Months 1, 3, 6, 9,16, 20, 24|"Extension population (considered as Safety population) consisted of all enrolled patients who received at least one dose of study medication in the extension study. n in each of the categories is the number of participants with data available at the given time-point."||Percentage of Participants|||Number
733169|NCT00414609|Secondary|Extension Study: Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Month 12|Change from baseline to Month 12 in left ventricular ejection fraction (LVEF) (%) as measured by echocardiography. LVEF is the fraction of blood (in percent) pumped out of the heart’s left ventricular chamber with each heart beat, and is a measure of cardiac output for the heart. This measurement was made by the echocardiography lab. Ejection fraction percentages > 55% are considered normal.|Baseline(extension study), Month 12 (extension study)|Echocardiogram Analysis Set consisting of all patients in the extension population who had acceptable ECHO measurements at extension baseline and Month 12.||percent of blood pumped from LV chamber||Standard Deviation|Mean
733170|NCT00414609|Secondary|Extension Study: Change From Baseline in Left Ventricular End Diastolic Volume (LVEDV) at Month 12|Change from baseline to Month 12 in left ventricular end diastolic volume (LVEDV) as measured by echocardiography. LVEDV is a measurement of the volume of blood in the heart’s left ventricular chamber at the beginning of the chamber’s filling with blood. This measurement was made by the echocardiography lab. LVEDV values between 67 to 155 mL for men and 56 to 104 mL for women are considered normal.|Baseline (extension study), Month 12 (extension study)|Echocardiogram Analysis Set consisting of all patients in the extension population who had acceptable ECHO measurements at extension baseline and Month 12.||Milliliter (mL)||Standard Deviation|Mean
733171|NCT00414609|Secondary|Extension Study: Change From Baseline in Left Ventricular End Systolic Volume (LVESV) at Month 12|Change from baseline to Month 12 in left ventricular end systolic volume (LVESV) as measured by echocardiography. LVESV is a measurement of the volume of blood in the heart’s left ventricular chamber at the end of the heart’s contraction. This measurement was made by the echocardiography lab. LVESV values between 22 to 58 mL for men and 19-49 mL for women are considered normal.|Baseline(extension study), Month 12 (extension study)|Echocardiogram Analysis Set consisting of all patients in the extension population who had acceptable ECHO measurements at extension baseline and Month 12.||Milliliter (mL)||Standard Deviation|Mean
733172|NCT00414609|Primary|Extension Study: Percentage of Participants With Deaths, Serious Adverse Events (SAEs), Discontinuation for Adverse Events (AEs) and Discontinuations for Abnormal Lab Values|AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.|Extension study (24 weeks)|Extension Population (considered as Safety population) consisting of all enrolled patients who received at least one dose of study medication in the extension study.||Percentage of participants|||Number
733173|NCT00414609|Secondary|Core Study: Change From Baseline to End of Study in Wall Motion Score (WMS) as Measured by Echocardiography|Change from baseline to end of study in Wall Motion Score (WMS) as measured by echocardiography. WMS was obtained by examining multiple segments of the left ventricle and assigning each segment a score based on myocardial thickening: 1 for normal, 2 for hypokinetic; 3 for akinetic; and 4 for dyskinetic. The WMS was obtained as the average score for the segments visualized and was calculated by the echocardiography lab. Possible values range from 1 to 5. Higher scores are considered worse. Baseline WMS was a covariate.|Baseline and final visit (after 26 to 36 weeks of treatment)|Echocardiogram evaluable set: Patients who had acceptable echocardiogram measurements both at baseline and at post-baseline after receiving at least 26 weeks of treatment.||Scores on a scale||Standard Error|Least Squares Mean
733174|NCT00414609|Secondary|Core Study: Change From Baseline to End of Study in Infarction Segment Length (ISL) as Measured by Echocardiography|Change from baseline to end of study in infarction segment length (ISL) (%) as measured by echocardiography. This is the length of the myocardial infarction segment as a percentage of the total cavity perimeter length as calculated by the echocardiography lab. Baseline ISL was a covariate.|Baseline and final visit (after 26 to 36 weeks of treatment)|Echocardiogram evaluable set: Patients who had acceptable echocardiogram measurements both at baseline and at post-baseline after receiving at least 26 weeks of treatment.||percent of total cavity perimeter length||Standard Error|Least Squares Mean
733175|NCT00414609|Secondary|Core Study: Change From Baseline in Left Ventricular Ejection Fraction (LVEF)|Change from baseline to end of study in left ventricular ejection fraction (LVEF) (%) as measured by echocardiography. LVEF is the fraction of blood (in percent) pumped out of the heart’s left ventricular chamber with each heart beat, and is a measure of cardiac output for the heart. This measurement was made by the echocardiography lab. Ejection fraction percentages > 55% are considered normal. Baseline LVEF was a covariate.|Baseline and final visit (after 26 to 36 weeks of treatment )|Echocardiogram evaluable set: Patients who had acceptable echocardiogram measurements both at baseline and at post-baseline after receiving at least 26 weeks of treatment.||percent of blood pumped from LV chamber||Standard Error|Least Squares Mean
733177|NCT00414609|Secondary|Core Study: Time to First Occurrence for the Composite Endpoints of Echocardiogram and Adjudicated Outcomes|Composite outcome 1 included: Cardiovascular (CV) Death, hospitalization for heart failure (HF), or absolute reduction in Left Ventricular Ejection Fraction (LVEF) greater than 6%. Composite outcome 2 included: CV Death, hospitalization for HF, recurrent Myocardial Infarction, Stroke, or Resuscitated Sudden Death. LVEF was measured at baseline and final visit. All other events were adjudicated by a blinded external committee. Each composite endpoint analysis was based on (a) the percent of patients with that endpoint and (b) days in study to 1st event (or last exposure if no event occurred).|LVEF was measured at baseline and at final visit (after 26 to 36 weeks of treatment). Other endpoint components were assessed from randomization until the end of the study (week 36).|Full Analysis Set (FAS) – All randomized patients who either (a) received study drug or (b) did not receive study drug but were not disqualified from randomization.||Percentage of participants|||Number
733178|NCT00414609|Primary|Core Study: Change From Baseline in Left Ventricular End Systolic Volume (LVESV) as Measured by Echocardiography at End of Study.|Change from baseline to end of study in left ventricular end systolic volume (LVESV) as measured by echocardiography. LVESV is a measurement of the volume of blood in the heart’s left ventricular chamber at the end of the heart’s contraction. This measurement was made by the echocardiography lab. LVESV values between 22 to 58 mL for men and 19-49 mL for women are considered normal. Baseline LVESV was a covariate.|Baseline and final visit (after 26 to 36 weeks of treatment)|Echocardiogram evaluable set (patients who had acceptable echocardiogram measurements both at baseline and at post-baseline after receiving at least 26 weeks of treatment)||mL||Standard Error|Least Squares Mean
733179|NCT00414635|Secondary|Deviation From FOTO Schedule by One Extra Dose|Percentage of FOTO participants who took a dose during weekend planned interuption period|4, 12, 24 weeks|||Percentage of Participants|||Number
733180|NCT00414635|Secondary|Self-reported Adherence Summary in Both Arms|Percentage of participants who missed one or more doses in weekly regimen.|4, 12 and 24 weeks|||percentage of participants|||Number
733181|NCT00414635|Secondary|Trough Blood Levels of Efavirenz in Both Arms|blood levels of efavirenz measured at 60 hours post last dose in FOTO arm and 12 hours post last dose in daily arm (control)|12 or 60 hours|||Percentage of Participants|||Number
733182|NCT00414635|Secondary|"Absolute Number of Virological Blip Events Occurring Over 24 Weeks"|"Total number of blip events in each arm. Blips are defined as HIV RNA > 50 and < 200 cps/ml"|Baseline to week 24|||blip events|||Number
733183|NCT00414635|Secondary|Quality of Life|"Participant preference of antiretroviral (ART) regimen determined on a scale ranging from 0 to 10. O was defined as I Perfer taking HIV medications 7 days/week and 10 was defined as I perfer 5 days on and 2 days off. We present results of a single question on quality of life experienced while on their study ART regimen."|4 weeks|The questionnaire was only applicable to FOTO arm||Units on a Scale||Inter-Quartile Range|Median
733184|NCT00414635|Secondary|Mean CD4+ T-cell Count Increases From Baseline to Week 24.||Baseline to Week 24|||cells/ml||95% Confidence Interval|Mean
733185|NCT00414635|Primary|Percentage of Participants Who Maintained Virologic Suppression (Less Than 50 RNA Cps/ml)|Percentage of Participants maintaining full Virologic Suppression (less than 50 RNA cps/ml)|24 weeks|Per protocol||Percentage of Participants|||Number
733186|NCT00414661|Other Pre-specified|Health Assessment Questionnaire-Disability Index (HAQ-DI) Score|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Month 6, 12, 18, 24|Safety analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for the measure and 'n' signifies participants evaluable at each time point for each arm respectively.||units on a scale||Standard Deviation|Mean
733187|NCT00414661|Primary|Incidence of Important Infections|Incidence rate was calculated separately for active treatment period and follow-up period in previous studies as number of participants with important infections by number of days while on active treatment or during follow-up period per 100 person-years. Standardization of incidence rates was based upon the age and sex distribution of the entire study population.|Up to Month 24|Safety analysis set included all participants who were previously enrolled in either randomized, controlled or open-label studies of CP-690,550 and had signed the informed consent form for this study.||Infections per 100 person-years||95% Confidence Interval|Number
733188|NCT00414661|Primary|Incidence of Lymphoma|Incidence rate was calculated separately for active treatment period and follow-up period in previous studies as number of participants with lymphoma by number of days while on active treatment or during follow-up period per 100 person-years. Standardization of incidence rates was based upon the age and sex distribution of the entire study population.|Up to Month 24|Safety analysis set included all participants who were previously enrolled in either randomized, controlled or open-label studies of CP-690,550 and had signed the informed consent form for this study.||Lymphoma per 100 person-years||95% Confidence Interval|Number
733189|NCT00414661|Primary|Incidence of Lymphoproliferative Disorders (LPD)|Incidence rate was calculated separately for active treatment period and follow-up period in previous studies as number of participants with LPD by number of days while on active treatment or during follow-up period per 100 person-years. Standardization of incidence rates was based upon the age and sex distribution of the entire study population.|Up to Month 24|Safety analysis set included all participants who were previously enrolled in either randomized, controlled or open-label studies of CP-690,550 and had signed the informed consent form for this study.||LPD per 100 person-years||95% Confidence Interval|Number
733190|NCT00414700|Post-Hoc|Number of Treatment Failures at 60 Months Post-surgery|"Participants with failed treatment - defined as the number of patients who underwent a reintervention of the index lesion - at 60 months.
The index lesion is the lesion that was initially treated in the study."|60 months|||participants|||Number
733205|NCT00414908|Secondary|Stool Consistency at the End of the Double-blind Period|4- point ordinal scale on this symptom from 0 (Hard) to 3 (Watery).|End of double-period (5-7 days)|The analysis was done on the Full Analysis sample. Full Analysis Population consists of all subjects who were allocated to the treatment and had data for at least one post-baseline assessment of any efficacy measurement.||Participants|||Number
733191|NCT00414700|Post-Hoc|Change From Baseline in Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) at 60 Months|Patient-administered instrument to assess the patients opinion about their knee and associated problems. It consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life QOL. The last week is taken into consideration when answering questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. The result can be plotted as an outcome profile.|60 months|FAS population with imputation for treatment failures by LOCF||units on a scale||Standard Error|Mean
733192|NCT00414700|Secondary|Safety: Adverse Events|Side effects are recorded as the number of patients with adverse events. These events are coded according to the Medical Dictionary for Regulatory Affairs (MedDRA terms).|continuous up to 60 months|||participants|||Number
733193|NCT00414700|Secondary|Number of Treatment Failures at 36 Months|"Participants with failed treatment - defined as the number of patients who underwent a reintervention of the index lesion - at 36 months.
The index lesion is the lesion that was initially treated in the study."|Continuous|||Participants|||Number
733194|NCT00414700|Secondary|Change From Baseline in Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) at 36 Months|Overall Knee injury and Osteoarthritis Outcome score (average of 4 KOOS subdomains: Activities of Daily Living, Quality of Life, Symptoms and Stiffness Pain; Sports not included) at 36 months (change from baseline). Best = 100; worst = 0.|Change from baseline in Overall KOOS at 36 months post-surgery|||Units on a scale||Standard Error|Mean
733195|NCT00414700|Primary|Change From Baseline in Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) at 12-18 Months (Average)|Overall Knee injury and Osteoarthritis Outcome score (average of 4 KOOS subdomains, Sports not included) at the average of 12-18 months (calculated by averaging change from baseline measurements at 12 and 18 months). Best score = 100; worst score = 0. The analysis was the average of the change from baseline at the 12 and 18 months timepoints.|Average change from baseline in Overall KOOS at 12-18 months post-surgery|FAS (with LOCF for treatment failures)||points on a scale (0-100)||Standard Error|Least Squares Mean
733196|NCT00414700|Primary|Overall Histology Assessment on First Subscale of ICRS II Score|Overall histology assessment of cartilage repair, first subscale of International Cartilage Repair Society II (ICRS II) score by two blinded independant histopathologists on a visual analogue scale (VAS 0-100mm) from worst (0) to best (100)|12 months post-surgery|FAS||Points on a scale||Standard Error|Least Squares Mean
733197|NCT00414700|Primary|Histomorphometry Safranin-O + Anti-Collagen II Antibody Staining|Histomorphometry on end point biopsies at 12 months post-surgery. Safranin-O (ratio 0-1)+ anti-Collagen II antibody (ratio 0-1) stain signal expressed as a ratio of the total cartilage surface area (Saf O + anti Coll II divided by total surface = ratio 0-2). Safranin-O stains proteoglycans and anti-Collagen II antibody reflects the presence of Collagen II.|12 months post-surgery|Full Analysis Set (FAS)||Ratio||Standard Error|Least Squares Mean
733200|NCT00414817|Secondary|Rate of Acute Health Care Visits for Asthma|annualized rate of acute asthma health care utilization events (urgent care, emergency department use, hospitalization) based on data derived from the electronic medical record. Each type of event was given equal weight for this analysis.|Measured over 19 months of follow-up|Study participants who were existing users of ICS at the outset of the study, qualified (or for UC would have qualified) for an intervention call at some point during the study, had at least 3 months of follow-up, and were not subsequently determined to be daily oral steroid users.||number of events per year||Standard Deviation|Mean
733201|NCT00414817|Secondary|Juniper Asthma Quality of Life Questionnaire (Global Score)|Asthma specific quality of life measurement developed by Dr. Elizabeth Juniper. This is the overall summary score and ranges from 1=poorest quality of life to 7=best quality of life.|Measured at 19 months|We assessed this outcome on a random sample of study participants that over-sampled intervention participants. All were existing users of ICS at the outset of the study who qualified for an intervention call at some point during the study, had at least 3 months of follow-up, and were not subsequently determined to be daily oral steroid users.||unitless scale ranging from 1-7||Standard Deviation|Mean
733202|NCT00414817|Primary|Modified Medication Possession Ratio|We used a modification of the Medication Possession Ratio (MPR) as our primary outcome measure. The MPR is computed as the number of days’ supply of medication dispensed during a given time window divided by the time between the first dispensing in the window and the end of the window. Our modified MPR (mMPR) also accounted for medication that was on hand at the start of the window and ignored any days’ supply that would extend beyond the end of the window. The MPR, and by extension the mMPR, assumes that medications were used as directed and that a new inhaled corticosteroid canister was not started until any medication on hand was exhausted.|Measured over 19 months|Study participants who were existing users of ICS at the outset of the study, qualified (or for UC would have qualified) for an intervention call at some point during the study, had at least 3 months of follow-up, and were not subsequently determined to be daily oral steroid users.||fraction of days with medication||Standard Deviation|Mean
733203|NCT00414908|Other Pre-specified|"Change of Stool Frequency Between Original Baseline and End of Open-label Period (OL)"|Stool frequency is the average of the daily number of stools recorded during the OL period. Lower values indicate a better response. Change was calculated as (OL stool frequency - Baseline stool frequency).|27 weeks|This analysis is done on the Open-Label period of 6 months.||Number||Standard Deviation|Mean
733204|NCT00414908|Secondary|Flatulence at the End of Double-blind Period|4- point ordinal scale on this symptom from 0 (None) to 3 (Severe).|End of double-period (5-7 days)|The analysis was done on the Full Analysis sample. Full Analysis Population consists of all subjects who were allocated to the treatment and had data for at least one post-baseline assessment of any efficacy measurement.||Participants|||Number
733208|NCT00414908|Secondary|Change From Baseline of Stool Nitrogen (g) Between Baseline and End of Double-blind (DB) Period.|Total amount of nitrogen excreted during the stool collection period. Lower values indicate a better response. Change was calculated as (DB Stool nitrogen - Baseline stool nitrogen).|End of double-period (5-7 days)|The analysis was done on the Full Analysis sample. Full Analysis Population consists of all subjects who were allocated to the treatment and had data for at least one post-baseline assessment of any efficacy measurement.||Grammes||Standard Error|Least Squares Mean
733209|NCT00414908|Secondary|Change From Baseline of Stool Fat (g) Between Baseline and End of Double-blind (DB) Period.|Total amount of fat excreted during the stool collection period. Lower values indicate a better response. Change was calculated as (DB Stool fat - Baseline stool fat).|End of double-blind period (5-7 days)|The analysis was done on the Full Analysis sample. Full Analysis Population consists of all subjects who were allocated to the treatment and had data for at least one post-baseline assessment of any efficacy measurement.||Grammes||Standard Error|Least Squares Mean
733210|NCT00414908|Secondary|Change of Coefficient of Nitrogen Absorption (CNA) (%) Between Baseline and End of Double-blind (DB) Period.|The CNA is calculated from nitrogen intake and nitrogen excretion : 100*[nitrogen intake-nitrogen excretion]/nitrogen intake. Higher values indicated a better response. Change is calculated as (DB CNA-Baseline CNA).|End of double-blind period (5-7 days)|The analysis was done on the Full Analysis sample. Full Analysis Population consists of all subjects who were allocated to the treatment and had data for at least one post-baseline assessment of any efficacy measurement.||Percentage||Standard Deviation|Mean
733211|NCT00414908|Primary|Change of Coefficient of Fat Absorption (CFA) (%) Between Baseline and End of Double-blind (DB) Period.|"The CFA is calculated from fat intake and fat excretion : 100*[fat intake-fat excretion]/fat intake. Higher values indicated a better response.
Change is calculated as (DB CFA-Baseline CFA)."|End of double-blind period (5-7 days)|The analysis was done on the Full Analysis sample. Full Analysis Population consists of all subjects who were allocated to the treatment and had data for at least one post-baseline assessment of any efficacy measurement.||Percentage||Standard Deviation|Mean
733212|NCT00414973|Secondary|Percentage Change From Baseline to 12 Weeks and 24 Weeks in Osteocalcin, Men|Measures of serum osteocalcin (nanograms per milliliter). Change = Endpoint minus baseline.|Baseline to 12 weeks and 24 weeks|Number of Intention to Treat patients with measurements at respective visit.||percentage change in osteocalcin||Inter-Quartile Range|Median
733213|NCT00414973|Secondary|Percentage Change From Baseline to 24 Week Endpoint in Total Hip Bone Mineral Density (BMD), Men|Total hip bone mineral density (milligrams per square centimeter) was measured by dual energy X-ray absorptiometry (DXA). Change = Endpoint minus baseline.|Baseline to 24 weeks|Number of Intention to Treat patients with baseline plus at least one post baseline measurement. Last Observation Carried Forward.||percentage change in total hip BMD||Standard Error|Least Squares Mean
733214|NCT00414973|Secondary|Percentage Change From Baseline to 24 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD), Men|Lumbar spine bone mineral density (milligrams per square centimeter) was measured by dual energy X-ray absorptiometry (DXA). Change = Endpoint minus baseline.|Baseline to 24 weeks|Number of Intention to Treat patients with baseline plus at least one post baseline measurement. Last Observation Carried Forward.||percentage change in lumbar spine BMD||Standard Error|Least Squares Mean
733215|NCT00414973|Secondary|Percentage Change From Baseline to 12 Weeks and 24 Weeks in Osteocalcin, Postmenopausal Women|Measures of serum osteocalcin (nanograms per milliliter). Change = Endpoint minus baseline.|Baseline to 12 weeks and 24 weeks|Number of Intention to Treat patients with measurements at respective visits.||percentage change in osteocalcin||Inter-Quartile Range|Median
733216|NCT00414973|Secondary|Percentage Change From Baseline to 24 Week Endpoint in Total Hip Bone Mineral Density (BMD), Postmenopausal Women|Total hip bone mineral density (milligrams per square centimeter) was measured by dual energy X-ray absorptiometry (DXA). Change = Endpoint minus baseline.|Baseline to 24 weeks|Number of Intention to Treat patients with baseline plus at least one post baseline measurement. Last Observation Carried Forward.||percentage change in total hip BMD||Standard Error|Least Squares Mean
733217|NCT00414973|Primary|Percentage Change From Baseline to 24 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD), Postmenopausal Women|Lumbar spine bone mineral density (milligrams per square centimeter) was measured by dual energy X-ray absorptiometry (DXA). Change = Endpoint minus baseline.|Baseline to 24 weeks|Number of Intention to Treat patients with baseline and at least one post baseline measurement. Last Observation Carried Forward.||percentage change in lumbar spine BMD||Standard Error|Least Squares Mean
733218|NCT00415051|Secondary|Genetic Stability - Characterize Viral Isolate (Plasma) Frequency|In vitro systems will be used to evaluate genetic stability (examining viremia levels in plasma by direct plaque assay techniques or by blind passage of plasma on Vero cells and sequencing the ribonucleic acid (RNA) and comparing these findings with those from the vaccine virus inoculum).|Days 0-14|1 subject was excluded for receiving another vaccination within 30 days of intended MP-12 vaccination.||Participants|||Count of Participants
733219|NCT00415051|Secondary|Immune Response Assessed by Measuring Days to Peak Response for (PRNT50) RVP MP-12 Vaccine|Immune response will be assessed by measuring days to peak response for PRNT50 antibodies to RVF virus|Days 0, 1, 2, 3, 7, 10, 14 and 28, Months 3, 6 and 12|||Days||Standard Deviation|Mean
733220|NCT00415051|Secondary|Immune Response Assessed by Measuring Days to Peak Response for PRNT80 Antibodies to RVF Virus|Immune response will be assessed by measuring days to peak response for PRNT80 antibodies to RVF virus|Days 0, 1, 2, 3, 7, 10, 14 and 28, Months 3, 6 and 12|||Days||Standard Deviation|Mean
733221|NCT00415051|Primary|Safety as Measured by the Number of Adverse Events|AE's will be assessed through study completion. Safety will be evaluated by recording the frequency of clinical reactions to the vaccine and by measuring complete blood counts and selected serum biochemistry (enzyme) values, rates of hospitalizations, and rates of lost duty/work time overall and by gender.|up to 1 year|||AEs|||Number
733222|NCT00415168|Secondary|Number of Participants Who Died During the Study||During study drug therapy up to six or eight 21-day cycles or treatment; maximum duration of study follow-up was 17.4 months|Full Analysis Set: This analysis set includes all data from all patients receiving at least one dose of the study drug.||participants|||Number
733223|NCT00415168|Secondary|Number of Participants With Pharmacology Toxicity - Grade 3 or 4 Non-Laboratory Toxicity Possibly Related to Study Therapy|Common toxicity criteria (CTC) Grade 3 (severe) or 4 (life-threatening or disabling) non-laboratory toxicity possibly related to study therapy. A grading (severity) scale is provided for each event term. Grades range from 0 (none) to 5 (death).|Baseline through six or eight 21-day cycles of treatment, up to 30 days after study drug discontinuation|Full Analysis Set: This analysis set includes all data from all patients receiving at least one dose of the study drug.||participants|||Number
733224|NCT00415168|Secondary|Number of Participants With Pharmacology Toxicity - Grade 3 or 4 Laboratory Toxicity Possibly Related to Study Therapy|Common toxicity criteria (CTC) Grade 3 (severe) or 4 (life-threatening or disabling) laboratory toxicity possibly related to study therapy. A grading (severity) scale is provided for each event term. Grades range from 0 (none) to 5 (death).|Baseline through six or eight 21-day cycles of treatment, up to 30 days after study drug discontinuation|Full Analysis Set: This analysis set includes all data from all patients receiving at least one dose of the study drug.||participants|||Number
733225|NCT00415168|Secondary|Overall Survival|Defined as the time from baseline to date of death due to any cause. Survival time is censored at the date of last contact for patients who are still alive or lost to follow up.|Baseline to date of death from any cause up to six or eight 21-day cycles of treatment; maximum duration of study follow-up was 17.4 months|Full Analysis Set: This analysis set includes all data from all patients receiving at least one dose of the study drug.||months||95% Confidence Interval|Median
733226|NCT00415168|Secondary|Progression Free Survival (PFS)|Defined as time from baseline to the date of disease progression or death on study, whichever occurs first. The PFS 1 definition from the United States Food and Drug Administration (FDA) draft guidance on clinical endpoints was used (FDA 2005).|Baseline to measured progressive disease or death up to six or eight 21-day cycles of treatment; maximum duration of study follow-up was 17.4 months|Full Analysis Set: This analysis set includes all data from all patients receiving at least one dose of the study drug.||months||95% Confidence Interval|Median
733227|NCT00415168|Secondary|Duration of Response|Measured from the time of first documentation of CR or PR (whichever status is first recorded) until the date of time to disease progression.|Time of response to progressive disease up to six or eight 21-day cycles of treatment; maximum duration of study follow-up was 17.4 months|Full Analysis Set: This analysis set includes all data from all patients receiving at least one dose of the study drug.||months||95% Confidence Interval|Median
733228|NCT00415168|Primary|Percentage of Participants With Objective Response (Objective Response Rate)|Tumor responder is defined as participants exhibiting a best overall study response of complete response (CR; disappearance of all target lesions) or partial response (PR; 30% decrease in sum of longest diameter of target lesions). Non-responders are those who did not meet the above criteria.|Baseline to time of response up to six or eight 21-day cycles of treatment|All patients enrolled in the study with a histologically confirmed diagnosis of adenocarcinoma of the gastric, disease status of measurable disease with presence of at least 1 measurable lesion, with no concurrent administration of any other tumor therapy or known or suspected brain metastasis who received at least 1 dose of study therapy.||percentage of responders||95% Confidence Interval|Number
733229|NCT00415194|Secondary|Correlation Between Biomarkers and Treatment Effect|"Correlation between highly up/downregulated genes and clinical response (Overall Survival (OS) and Progression-Free Survival (PFS)). OS is is defined as the time from the date of randomization to the date of death from any cause. PFS is defined as the time from the date of randomization to the date of objectively determined progressive disease or death from any cause, whichever comes first.
0 participants were analyzed; Reason: The relatively low number of samples collected would not have yielded a meaningful genomic analysis and the decision was made to not analyze the data."|Baseline|Zero participants were analyzed because the relatively low number of samples collected would not have yielded a meaningful genomic analysis.||correlation coefficient|||Number
733230|NCT00415194|Secondary|Time to Treatment Worsening in Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Total Score|FACT-H&N consists of 39 items with 5-point rating scale from 0 (not at all) to 4 (very much). FACT-H&N Total score ranges from 0 to 148. Higher score represents a better quality of life. Time to worsening was defined as the first date of worsening in the FACT H&N Total score that was considered at least the prospectively defined minimally important difference (MID) as compared with participant’s baseline score, or date of death from any cause. The MID for FACT H&N Total score was a decrease of 12 points.|Baseline (</=Day 1 of first dose) and Day 1 of every subsequent cycle to 30-day post-study completion up to 33 months|Intention to treat (ITT) population with at least Baseline data.||Months||95% Confidence Interval|Median
733231|NCT00415194|Secondary|Duration of Response (DoR)|DoR is time from first observation of complete response (CR) or partial response (PR) to first observation of PD or death. Response is objective status of CR or PR using RECIST criteria. CR is disappearance of lesions. PR is >30% decrease in size of lesions. Responder is any participant with CR or PR. PD is at least 20% increase in sum of longest diameter of target lesions. For participants alive as of data-inclusion cut-off date and who do not have PD, DoR will be censored at date of last objective progression-free disease assessment before date of any subsequent systemic anticancer therapy.|time of response to progressive disease up to 24 months|ITT population with a confirmed best response of complete response (CR) or partial response (PR).||Months||95% Confidence Interval|Median
733232|NCT00415194|Secondary|Percent of Participants With a Tumor Response (Response Rate)|Tumor Response is evaluated as CR (Complete Response) or PR (Partial Response) per Response Evaluation Criteria in Solid Tumors (RECIST criteria). Possible evaluations include: CR: Disappearance of all target lesions. PR: At least a 30% decrease in the size of target lesions. Response rate (%) = (number of participants with CR+PR/number of participants)*100|Baseline to progressive disease or discontinuation of study treatment up to 11 months|Intention to Treat (ITT) Population - defines the treatment group as those to which participants were assigned by random allocation, even if a participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol.||Percentage of participants|||Number
733244|NCT00415532|Primary|Number of Participants With Treatment Failure During 52-Week Treatment Period|Treatment failure was defined by platelet counts ≤ 20 x 10^9/L for 4 consecutive weeks at the highest recommended dose and schedule, a major bleeding event, or change in therapy due to an intolerable side effect or bleeding symptom.|52 weeks|Full analysis set. Participants who discontinued study during treatment period prior to experiencing treatment failure were considered as having had treatment failure.||Participants|||Number
733233|NCT00415194|Secondary|Progression-free Survival (PFS)|Objective PFS is defined as the time from date of randomization to date of objectively determined progressive disease (PD) or death from any cause, whichever comes first. PD was defined by Response Evaluation Criteria in Solid Tumors (RECIST). PD=at least a 20% increase in sum of longest diameter of target lesions. For participants who are not known to have died as of the data-inclusion cut-off date, and who do not have progressive disease, PFS will be censored at the date of the last objective progression-free disease assessment prior to the date of any subsequent systemic anticancer therapy.|baseline to measured progressive disease up to 33 months|Intention to Treat (ITT) Population - defines the treatment group as those to which participants were assigned by random allocation, even if a participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol.||months||95% Confidence Interval|Median
733234|NCT00415194|Primary|Overall Survival (OS)|OS duration is defined as the time from the date of randomization to the date of death from any cause. For each participant who is not known to have died as of the data-inclusion cut-off date, OS duration will be censored at the date of the participant’s last contact prior to that cut-off date.|Baseline to date of death from any cause up to 36 months|Intention to Treat (ITT) Population - defines the treatment group as those to which participants were assigned by random allocation, even if a participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol.||Months||95% Confidence Interval|Median
733235|NCT00415493|Primary|Net Proportional Change in Nasal Airway Resistance|Net proportional change in nasal airway resistance, pre- to post-exposure, cold air minus warm air day, calculated as a time-weighted average over the 1.0 h post-exposure. At each time point (pre-exposure, immediately post-exposure, and at 15-, 30-, 45- and 60 minutes post-exposure), nasal airway resistance (in Pa/L/sec) was measured in triplicate. The average of each of these measures was taken for each time point. The time-weighted average of these averages was then calculated for the post-exposure time points and compared with the baseline average for that individual on that testing day. The proportional change from baseline on that day was then calculated (unit-less measure). The difference between the pre-to-post change on the cold air day minus the pre-to-post change on the warm air day was then calculated (unit-less measure). The net proportional change corrects for both inter- and intra-individual variability, which in the case of nasal airway resistance is considerable.|One hour|||proportional change (unit-less)||Standard Error|Mean
733236|NCT00415506|Primary|Improved Control of Inflammation|"For patients with scleritis, disease activity as measured by a modified grading system first described by McCluskey et al. (McCluskey and Wakefield 1987; McCluskey and Wakefield 1991). Improvement in scleritis activity will be defined as a reduction in this grading score of 2 or more, or an overall score of 4 or less by 24 weeks.
For patients with orbital inflammation, disease activity as measured by a modified grading system first devised by Werner (Werner 1977). Improvement in orbital inflammation will be defined as a reduction in this grading score of 2 or more, or an overall score of 3 or less."|24 weeks|||participants|||Number
733237|NCT00415506|Primary|Reduction of Medications|Reduction (decrease in dosage) of systemic corticosteroids or immunosuppressive therapy by at least 50% by 24 weeks.|24 Weeks|Only patients currently on systemic corticosteroids were analyzed for this outcome point.||participants|||Number
733238|NCT00415532|Secondary|Change in ITP-PAQ Physical Health Domain of Activity|"Change from Baseline in the Immune Thrombocytopenic Purpura (ITP) Patient Assessment Questionnaire (PAQ) physical health domain of activity. This domain has a range of 0 to 100, with higher scores indicating a better health-related quality of life.
Model included fixed effects of baseline assessment, geographic region, treatment group, assessment week, splenectomy status and treatment group-by-assessment week interaction. Treatment group and splenectomy status are time-varying covariates."|Baseline and 52 weeks|Full analysis set||Units on a scale||Standard Error|Least Squares Mean
733239|NCT00415532|Secondary|Change in ITP-PAQ Physical Health Domain of Bother|Change from Baseline in the Immune Thrombocytopenic Purpura (ITP) Patient Assessment Questionnaire (PAQ) physical health domain of bother. This domain has a range of 0 to 100, with higher scores indicating a better health-related quality of life. Model included fixed effects of baseline assessment, geographic region, treatment group, assessment week, splenectomy status and treatment group-by-assessment week interaction. Treatment group and splenectomy status are time-varying covariates.|Baseline and 52 weeks|Full analysis set||Units on a scale||Standard Error|Least Squares Mean
733240|NCT00415532|Secondary|Change in ITP-PAQ Physical Health Domain of Fatigue|Change from Baseline in the Immune Thrombocytopenic Purpura (ITP) Patient Assessment Questionnaire (PAQ) physical health domain of fatigue. This domain has a range of 0 to 100, with higher scores indicating a better health-related quality of life. Model included fixed effects of baseline assessment, geographic region, treatment group, assessment week, splenectomy status and treatment group-by-assessment week interaction. Treatment group and splenectomy status are time-varying covariates.|Baseline and 52 weeks|Full analysis set.||Units on a scale||Standard Error|Least Squares Mean
733241|NCT00415532|Secondary|Change in ITP-PAQ Physical Health Domain of Symptoms|"Change from Baseline in the Immune Thrombocytopenic Purpura (ITP) Patient Assessment Questionnaire (PAQ) physical health domain of symptoms. This domain has a range of 0 to 100, with higher scores indicating a better health-related quality of life.
Model included fixed effects of baseline assessment, geographic region, treatment group, assessment week, splenectomy status and treatment group-by-assessment week interaction. Treatment group and splenectomy status are time-varying covariates."|Baseline and 52 weeks|Full analysis set||Units on a scale||Standard Error|Least Squares Mean
733242|NCT00415532|Secondary|Percentage of Participants With Platelet Response|Platelet response was defined as platelet counts > 50 x 10^9/L, measured at each study visit (excluding those within 8 weeks of prior rescue medication use) up to the time of splenectomy or the end of initial treatment period, whichever occurred first.|Weeks 1-8, and Weeks 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52|"Full analysis set. N indicates the number of participants with available data at each time point."||percentage of participants|||Number
733243|NCT00415532|Secondary|Time to Splenectomy|Time to splenectomy in days calculated from date of randomization to date of splenectomy, or censored at date of end of treatment visit if no splenectomy was done during treatment period.|52 weeks|Full analysis set||days||95% Confidence Interval|Median
733245|NCT00415532|Primary|Number of Participants With Splenectomy During 52-Week Treatment Period|Occurrence of a splenectomy. Participants who discontinued study during the treatment period prior to reporting a splenectomy were considered as having had a splenectomy.|52 weeks|The Full Analysis set includes all randomized patients.||Participants|||Number
733249|NCT00415610|Secondary|Tolerability, the Ability of Subjects to Tolerate Rapid Systolic Blood Pressure Reduction and Maintain Treatment Goals|The ability to maintain the Specified Systolic Blood Pressure Range for the 18-24 Hour Period without Neurological Deterioration or Side Effects|3 months|All subjects were analyzed by treatment arm for the presence of SAEs, neurological deterioration, symptomatic or asymptomatic hematoma expansion, and mortality in-hospital or within 3 months. Pre-specified safety stopping rules were used. The nature and relatedness of events was examined and overseen by an external Data safety and Monitoring Board.||participants|||Number
733250|NCT00415610|Primary|Safety, Acute, as Determined by the Amount of Neurological Deteriorations During the 24 Hour Treatment Period, Plus the Number of Serious Adverse Events.|Safety outcomes were defined as the rate of neurological deterioration during treatment, and the rate of serious adverse events related to nicardipine. Safety stopping rules were pre-specified and were overseen by an external DSMB. Because SBP reduction may progress variably, additional analyses were also done to examine the relationship between SBP reduction and safety events more closely. The average SBP change at 2 hours after treatment initiation was compared among subjects who did or did not have neurological deterioration within 24 hours to evaluate the relationship between early SBP reduction and safety events. For each subject who experienced neurological deterioration (ND) within 24 hours, a graph of average hourly SBP and nicardipine dose was examined with timing of the ND noted. Therefore safety was evaluated according to assigned treatment group and also according to actual treatment magnitude within a clinically meaningful timeline for all subjects enrolled.|within the first 72 hours of treatment initiation|All subjects entered in the trial were followed and their data analyzed for safety measures. Not all subjects entered in the trial survived or remained in the trial to assess final outcomes at 1 or 3 months. Because safety stopping rules could not have triggered after 18 initial subjects, recruitment was adjusted to weight the intensive tier.||participants|||Number
733251|NCT00415610|Primary|Feasibility, the Ability to Achieve and Maintain the Systolic Blood Pressure Goals for Each Treatment Tier.|Feasibility of treatment was assessed by whether SBP reduction and maintenance within the respective target range was achieved (treatment success) or not (treatment failure), and secondarily by whether a significant difference between treatment arms was achieved. Treatment failure was defined based on the observed hourly hourly minimum SBP remaining greater than the upper limit of the target range for 2 consecutive hours after initiation of nicardipine infusion. Spontaneous decline of SBP below the lower limit of the specific tier was not considered treatment failure as all such declines were asymptomatic.The lower number in the more intensive treatment groups reflects in part the greater challenge of rapidly lowering systolic blood pressure to a more intensive (lower) range, as a higher number of treatment failures as pre-defined by meeting the SBP range goal within 3 hours of symptom onset in this group predictably occurred.|Within 3 hours of symptom onset and sustained through 18-24 hours.|All subjects were evaluated for achievement of the treatment goals.||participants|||Number
733252|NCT00415623|Secondary|Trough Plasma Concentrations of Amlodipine -Amlodipine 10 mg||Baseline, Week 4, and Week 8|Plasma concentration obtained after temporarily dosing discontinuation or not matched with the following conditions were excluded from the analysis; Steady-state condition: at least 80% drug compliance from the previous visit to the day of sampling; Trough condition: samples taken within ±10% of 24 hours from last dosing.||ng/mL||95% Confidence Interval|Geometric Mean
733253|NCT00415623|Secondary|Trough Plasma Concentrations of Amlodipine -Amlodipine 5 mg||Baseline, Week 4 and Week 8|Plasma concentration obtained after temporarily dosing discontinuation or not matched with the following conditions were excluded from the analysis; Steady-state condition: at least 80% drug compliance from the previous visit to the day of sampling; Trough condition: samples taken within ±10% of 24 hours from last dosing.||ng/mL||95% Confidence Interval|Geometric Mean
733254|NCT00415623|Secondary|Combined Number of Subjects Achieving the Target Blood Pressure Reduction Value and Whose SBP Decreased From Baseline by >= 10 mmHg at Both Weeks 6 and 8|Target blood pressure reduction value based on Japan Society of Hypertension Guidelines for the Management of Hypertension 2004: SBP below 130 mmHg and DBP below 85 mmHg for <=64 years old; SBP below 140 mmHg and DBP below 90 mmHg for >=65 years old|Week 6 and Week 8|Full Analysis Set, Last Observation Carried Forward||participants|||Number
733255|NCT00415623|Secondary|Number of Subjects Achieving the Target Blood Pressure Reduction Value and Whose SBP Decreased From Baseline by >= 10 mmHg at Week 8|Target blood pressure reduction value based on Japan Society of Hypertension Guidelines for the Management of Hypertension 2004: SBP below 130 mmHg and DBP below 85 mmHg for <=64 years old; SBP below 140 mmHg and DBP below 90 mmHg for >=65 years old|Week 8|Full Analysis Set, Last Observation Carried Forward||participants|||Number
733256|NCT00415623|Secondary|Combined Number of Subjects Achieving the Target Blood Pressure Reduction Value at Both Weeks 6 and 8|Target blood pressure reduction value based on Japan Society of Hypertension Guidelines for the Management of Hypertension 2004: SBP below 130 mmHg and DBP below 85 mmHg for <=64 years old; SBP below 140 mmHg and DBP below 90 mmHg for >=65 years old|Week 6 and Week 8|Full Analysis Set, Last Observation Carried Forward||participants|||Number
733257|NCT00415623|Secondary|Number of Subjects Achieving the Target Blood Pressure Reduction Value at Week 8|Target blood pressure reduction value based on Japan Society of Hypertension Guidelines for the Management of Hypertension 2004: SBP below 130 mmHg and DBP below 85 mmHg for <=64 years old; SBP below 140 mmHg and DBP below 90 mmHg for >=65 years old|Week 8|Full Analysis Set, Last Observation Carried Forward||participants|||Number
733258|NCT00415623|Secondary|Combined Mean Change in DBP From Baseline to Week 6 and Week 8 (Mean by Patient)|Arithmetic mean of Week 6 & Week 8 by patient for “Change from baseline in DBP at Week 6” and “Change from baseline in DBP at Week 8”|Baseline to Week 6 and Week 8|Full Analysis Set, Last Observation Carried Forward||mmHg||95% Confidence Interval|Least Squares Mean
733259|NCT00415623|Secondary|Combined Mean Change in SBP From Baseline to Week 6 and Week 8 (Mean by Patient)|Arithmetic mean of Week 6 & Week 8 by patient for “Change from baseline in SBP at Week 6” and “Change from baseline in SBP at Week 8”|Baseline to Week 6 and Week 8|Full Analysis Set, Last Observation Carried Forward||mmHg||95% Confidence Interval|Least Squares Mean
733260|NCT00415623|Secondary|Change in Diastolic Blood Pressure (DBP) From Baseline to Week 8|Mean change in the trough DBP|Baseline to Week 8|Full Analysis Set, Last Observation Carried Forward||mmHg||95% Confidence Interval|Least Squares Mean
733261|NCT00415623|Primary|Change in Systolic Blood Pressure (SBP) From Baseline to Week 8|Mean change in the trough SBP|Baseline to Week 8|Full Analysis Set, Last Observation Carried Forward||mmHg||95% Confidence Interval|Least Squares Mean
733262|NCT00415857|Secondary|Number of Participants With Immunologic Response|Immunologic Response (immune response) is defined as an increase of ≥ 0.5 PR1-HLA-A2 [human leukocyte antigen-A2 (HLA-A2)] tetramer cells / μl at the time of either the 3rd or 4th vaccination compared to the pre study absolute PR1-HLA-A2 tetramer cells / μl. Participants receive a total of 4 vaccinations over a period of 18 weeks (i.e., one vaccination each on weeks 0, 3, 6, and 18). Participants assessed after 3rd and 4th vaccination for immunologic response.|Period of 18 weeks (i.e., one vaccination each on weeks 0, 3, 6, and 18).|||participants|||Number
733263|NCT00415857|Primary|Molecular Response Rate|Molecular response rate is number of respondents compared to total participants. Molecular Response is defined as a greater than a one-log reduction of Breakpoint Cluster Region-Abelson Murine Leukemia (BCR-ABL) transcript levels by quantitative polymerase chain reaction (PCR) from the baseline level at the time vaccination was initiated, or a disappearance of BCR-ABL transcripts, as measured by reverse transcription polymerase chain reaction (RT-PCR), occurring within 6 months from the last vaccination. Participants receive a series of 4 vaccinations administered at 3-week intervals and the fourth (final) vaccination administered 3 months after the third vaccination with blood draw to test PCR following every 3 months to test the level of leukemia in the blood and to see if disease is responding to the vaccine.|Baseline to 18 weeks, up to 6 months post final vaccination for overall study participation period.|||percentage of participants|||Number
733264|NCT00415870|Secondary|to Assess Satisfaction With mDIET. Satisfaction Will be Measured by Subjective Ratings of Intervention Components and Ease of Use, and Objective Measures of Frequency of Use.||4 months||||||
733265|NCT00415870|Secondary|to Assess Compliance With Food Monitoring Activities (e.g, Type of Food, Amount) Via the Cell Phone. Compliance Will be Measured as a Percentage of Monitoring Logs Completed and Submitted Via Phone||4 months||||||
733266|NCT00415870|Primary|The Primary Outcome Will be the Effect of the mDIET System in Comparison to a Control Group on BMI Among Overweight Men and Women.||4 months|||kg||Standard Deviation|Mean
733267|NCT00415909|Primary|Response Rate (Major and Complete Cytogenetic Response)|Rate is defined as number of participants with response of Major and Complete cytogenetic response out of total study participants. Response evaluated at one and 3 months from start of therapy, then every 3 months in patients with response, for one year, then every 6-12 months. Responses classified according to suppression of Philadelphia (Ph) chromosome by cytogenetic analysis: a) Complete cytogenetic response - Not Ph positive; b) Major cytogenetic response - Ph positive 1-34% of pretreatment value; c) Minor cytogenetic response - Ph positive 35-65% of pretreatment value; d) Minimal cytogenetic response - Ph positive 65-99% of pretreatment value; e) No cytogenetic response - Ph positive 100% of pretreatment value.|Evaluated at baseline (pretreatment) up to 12 months|All three patients received the planned 9 administrations of TALL-104.||percentage of participants|||Number
733268|NCT00416078|Other Pre-specified|Number of Participants Placed in Assisted Living or Nursing Homes 12 Months From Baseline|Frequency count of individuals placed in assisted living or nursing homes|baseline to end-of-follow-up (12 months from baseline)|Numbers vary; patients only at risk for out-of-home placement if alive and with data during follow-up periods||participants|||Number
733269|NCT00416078|Primary|Change in Caregiver Depression From Baseline|Total score on the Beck Depression Inventory. The Beck Depression Inventory is a 21 item likert scale instrument with a total range of 0 to 63. Higher scores are indicative of increased endorsement of depressive symptoms. Additionally, it utilizes a cutoff score of13 to indicate probable depression|baseline to end-of-treatment (6 months)|Data available for analyses vary due to missing data (lost to follow-up and deaths at different points in the protocol; incomplete forms)||units on a scale||Standard Error|Least Squares Mean
733270|NCT00416078|Primary|Change in Caregiver Negative Reactions to Problematic Behavioral Patterns From Baseline|Total Score on the Negative Reactions Scale from the Revised Memory and Behavior Problem Checklist. The scale measures the caregiver’s level of reaction to a series of potential problematic behaviors on a 0-4 likert scale; higher numbers indicate a greater degree of distress. The range is 0-96.|baseline to end of treatment (6 months)|Data available for analyses vary due to missing data (lost to follow-up and deaths at different points in the protocol; incomplete forms)||units on a scale||Standard Error|Least Squares Mean
733271|NCT00416078|Primary|Change in Frequency of Patient Problematic Behavioral Patterns From Baseline|Total Score on the Frequency of Problematic Behaviors on the Revised Memory and Behavior Problem Checklist. The Revised Memory and Behavior Checklist is a 24 item instrument that measures the frequency of a behavior on a 0-4 likert scale wherein higher numbers indicate greater frequency. The range is 0-96.|baseline to end of treatment (6 months)|Data available for analyses vary due to missing data (lost to follow-up and deaths at different points in the protocol; incomplete forms)||units on a scale||Standard Error|Least Squares Mean
733272|NCT00416078|Primary|Change in Caregiver Burden From Baseline|Total score on the Zarit Short Burden Scale, a 12 item instrument that utilizes a likert scale 1-5 rating of frequency. The range is 12 (never) to 60 (nearly always) wherein higher scores are more indicative of caregiver burden.|baseline to end-of-treatment (6 months)|Data available for analyses vary due to missing data (lost to follow-up and deaths at different points in the protocol; incomplete forms)||units on a scale||Standard Error|Least Squares Mean
733273|NCT00416078|Secondary|Change in Caregiver Report of Patient Medication Adherence From Baseline|Adherence to prescribed medication regimen rated by caregiver on a 1 (0%) to 5 (100%) scale. Higher scores indicate better adherence. Values in statistical table below are least square estimates, and thus may be slightly out-of-range of actual respondent choices on scale.|baseline to end-of-treatment (6 months)|measure was added to study while in process||units on a 1-5 scale||Standard Error|Least Squares Mean
733274|NCT00416182|Secondary|Pulmonary Function|prior to surgery and end of study spirometry as measured by forced expiratory volume in 1 second (FEV1) percent predicted. The change over the course of the study (1 year minus baseline) is reported. A higher value indicates a better outcome.|baseline and 1 year|||percentage of predicted FEV1||Full Range|Mean
733275|NCT00416182|Secondary|Chronic Sinusitis Survey Score|pre-surgery and end of trial (12 months) Reduction in scores (baseline minus 1 year) are recorded The chronic sinusitis survey consists of 6 questions, ranges from 0-24, a lower score indicates the best possible outcome.|baseline and 1 year|||units on a scale||95% Confidence Interval|Mean
734284|NCT00425308|Secondary|Assessing Cardiovascular Risk Factors Based on Fasting High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol.||From Baseline to Month 3, 6, and 12|Safety population||mmol/L||Standard Deviation|Mean
733276|NCT00416182|Primary|Improvement in Appearance of Nasal Passages/Sinuses|"periodic endoscopic photos of sinuses by ear-nose-throat (ENT) surgeon. The scale for scoring severity of disease ranges from 0 (best possible outcome) to 2 (worst possible outcome).
independent blinded scoring by 2 surgeons difference in scores pre and post are reported (1 year minus baseline)"|baseline and 1 year|||units||95% Confidence Interval|Mean
733277|NCT00416182|Primary|Computed Tomography Evidence of Less Sinus Disease|compare sinus CT pre-op (baseline) to one year after initiation of study drug Difference in pre and post scores by Lund-McKay scoring system are reported (1 year minus baseline) The Lund-Mackay scoring system was used to evaluate the extent and severity of sinusitis. The scale ranges from 0 (best possible outcome with complete lucency of all sinuses) to 24 (worst possible outcome with complete opacification of all sinuses)|baseline and 1 year|||units on a scale||95% Confidence Interval|Mean
733278|NCT00416195|Secondary|Percentage Change in the 28-day Seizure Frequency From Baseline in the Maintenance LOCF||Baseline, Day 85 through Day 112|ITT population (LOCF)||Percent change||Full Range|Median
733279|NCT00416195|Primary|Percentage of Responders During the Maintenance Phase|A patient is a responder if she/he experiences a 50% or greater reduction in seizure frequency from the baseline phase.|Day 85 through Day 112|ITT population- all subjects in the Safety Population (all randomized subjects who took at least 1 dose of study drug) who had at least 2 weeks of baseline seizure frequency data and at least 1 week of seizure frequency data after baseline (LOCF - last observation carried forward)||Percentage of Participants|||Number
733280|NCT00416455|Primary|Percent of Patients That DCT Will Indicate Positive Among Those With Lymph Node Metastasis in Pelvis||Before surgery (DCT) and after surgery (pathology)|Abdominal positive and negative patients. Cervical cancer cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 23 randomly selected abdominal negative patients.||percentage of patients||95% Confidence Interval|Number
733281|NCT00416455|Primary|Percent of Patients That FDG-PET-CT Will Indicate Positive Among Those With Lymph Node Metastasis in Pelvis||Before surgery (FDG-PET-CT) and after surgery (pathology)|Abdominal positive and negative patients. Cervix cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 23 randomly selected abdominal negative patients||percentage of patients||95% Confidence Interval|Number
733282|NCT00416455|Secondary|Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0||Up to 5 years||||||
733283|NCT00416455|Secondary|Cause(s) of Delay in the Initiation of Radiotherapy or Interruption in Radiotherapy in Patients With Locoregionally Advanced Cervical Cancer||Up to 5 years||||||
733284|NCT00416455|Secondary|Complications Associated With Extraperitoneal or Laparoscopic Abdominal and Pelvic Lymphadenectomy in Patients With Locoregionally Advanced Cervical Cancer||Up to 5 years||||||
733285|NCT00416455|Secondary|Accuracy of MRI in Determining the Depth of Myometrial Invasion and Involvement of Cervix in Patients With High-risk Endometrial Cancer||Up to 5 years||||||
733286|NCT00416455|Secondary|Percentage of Patients With Locoregionally Advanced Cervical Cancer or High-risk Endometrial Cancer Who Have Biopsy-proven Disease Outside the Abdominal or Pelvic Lymph Nodes Detected by PET/CT Scanning||Up to 5 years||||||
733287|NCT00416455|Secondary|Comparison of the Diagnostic Sensitivity and Specificity of Ferumoxtran-10 MRI vs MRI Alone, in Terms of Size Criteria in the Abdomen and Pelvis||Up to 5 years||||||
733288|NCT00416455|Secondary|Comparison of the Diagnostic Sensitivity and Specificity of PET/CT Scan vs PET Scanning Alone in Identifying Metastases to Pelvic, Abdominal, and Combined (All Regions) Lymph Nodes||Up to 5 years||||||
733289|NCT00416455|Primary|Percent of Patients That DCT Will Indicate Positive Among Those With Lymph Node Metastasis in Abdomen||Before surgery (DCT) and after surgery (pathology)|Abdominal positive and negative patients. Cervix cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 23 randomly selected abdominal negative patients.||percentage of patients||95% Confidence Interval|Number
733290|NCT00416455|Primary|Percent of Patients That FDG-PET-CT Will Indicate Positive Among Those With Lymph Node Metastasis in Abdomen||Before surgery (FDG-PET-CT) and after surgery (pathology)|Abdominal positive and negative patients. Cervix cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 23 randomly selected abdominal negative patients||percentage of patients||95% Confidence Interval|Number
733291|NCT00416494|Other Pre-specified|Effect on Wound Angiogenesis||After study completion||||||
733292|NCT00416494|Other Pre-specified|Effect on Angiogenesis Biomarkers||After study completion||||||
733293|NCT00416494|Secondary|Safety and Tolerability|Number of participants with adverse events|After all participants went off study drug regimine.|||participants with adverse event|||Number
733294|NCT00416494|Secondary|Overall Survival|Average months of survival of participants after receiving study drug.|From time of treatment until death from any cause, assesed up to 60 months.|||months||95% Confidence Interval|Median
733295|NCT00416494|Secondary|Disease Free Survival|"Disease assessment was performed and recorded according to the Response Evaluation Criteria in Solid Tumors (RECIST v.1.0) Guidelines.
Progressive disease is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions."|From time of treatment until documented progression or death from any cause, whichever came first, assesed up to 60 months.|||months||95% Confidence Interval|Median
733296|NCT00416494|Secondary|Time to Progression|"Disease assessment was performed and recorded according to the Response Evaluation Criteria in Solid Tumors (RECIST v.1.0) Guidelines.
Progressive disease is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions."|From time of treatment until documented progression, assesed up to 60 months.|||months||95% Confidence Interval|Median
733339|NCT00410813|Secondary|Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Up to 2 years|Eligible patients who received any treatment and were assessed for toxicity were included in the adverse event summaries. Any CTCAE v3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.||Participants|||Number
733297|NCT00416494|Primary|Response Rate (Percentage of Participants With Partial or Complete Response)|"Restaging scans occurred every 9 weeks from time of study drug initiation until disease progression.
Disease assessment was performed and recorded according to the Response Evaluation Criteria in Solid Tumors (RECIST v.1.0) Guidelines.
The definitions were:
Complete response (CR)- Disappearance of all target lesions Partial response (PD)- At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Stable disease (SD)- Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Progressive disease (PD) - At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions"|After all subjects were evaluated for restaging which occured every 9 weeks from drug initiation until disease progression, assesed up to 24 months.|All subjects who had restaging scans were included in the analysis.||percentage of participants with response||95% Confidence Interval|Number
733298|NCT00416520|Secondary|Change in Serum Phosphorus Levels From Baseline to Week 12 (LOCF) (ITT1)|ITT1 population included all subjects who received a randomisation number (at Week 0), took at least 1 dose of study medication and had at least 1 central serum phosphorus value after the start of study medication.|week12 minus week0|ITT1 population included all subjects who received a randomisation number (at Week 0), took at least 1 dose of study medication and had at least 1 central serum phosphorus value after the start of study medication.||mg / dL||Standard Deviation|Mean
733299|NCT00416520|Primary|Change in Serum Phosphorus Levels From Week 12 to Week 16 (LOCF) (ITT2)|ITT2 population included all re-randomised subjects who completed 12 weeks in the MCI-196 treatment group and received at least 1 dose of study medication in the placebo-controlled withdrawal period and had at least 1 central serum phosphorus value after 12 weeks.|week16 minus week12|ITT2 population included all re-randomised subjects who completed 12 weeks in the MCI-196 treatment group and received at least 1 dose of study medication in the placebo-controlled withdrawal period and had at least 1 central serum phosphorus value after 12 weeks.||mg / dL||Standard Deviation|Mean
733300|NCT00416572|Primary|Mental Health (Measured With the SF-36) at Baseline, Post-intervention (4-months Post-intervention) and Final Follow-up (13-months Post-intervention)|The Mental Health Component Scale of the Medical Outcomes Study Short Form 36 (SF-36) consists of a norm-based weighted average of the following subscales: vitality, social functioning, role limitations due to emotional problems and mental health. In the present study, scores ranged from a maximum of 68 (high levels of mental health) to a minimum of 15 (low levels of mental health).|Baseline, Post-intervention(4 months post-intervention), Final Follow-up(13 months post-intervention)|All women who agreed to random assignment and completed all three assessments were retained in the analysis regardless of their level of group attendance.||units on a scale||Standard Deviation|Mean
733301|NCT00416572|Primary|Perceived Physical Health (Measured With SF-36) at Baseline, Post-intervention (4-months Post-intervention) and Final Follow-up (13-months Post-intervention)|The Perceived Physical Health Component scale of the Medical Outcomes Study Short Form 36 (SF-36) consists of a norm-based weighted average of the following subscales: Physical functioning, bodily pain, role limitations due to physical problems and general health. In the present study, scores ranged from a maximum of 68 (high levels of perceived health) to a minimum of 24 (low levels of perceived health).|Baseline, Post-intervention(4 months post-intervention), and Final Follow-up(13 months post-intervention)|All women who agreed to random assignment and completed all three assessments were retained in the analysis regardless of their level of group attendance.||units on a scale||Standard Deviation|Mean
733302|NCT00416572|Primary|Depressive Symptoms (Measured With an Abbreviated 10-item CES-D) at Baseline, Post-intervention (4-months Post-intervention) and Final Follow-up (13-months Post-intervention).|Scores for the shortened form of the Center for Epidemiologic Studies Depression scale(CES-D) ranged from 0 (no depressive symptoms) to 24 (high levels of depressives symptoms) in the present sample.|Baseline, Post-intervention(4 months post-intervention) and Final Follow-up(13 months post-intervention).|All women who agreed to random assignment and completed all three assessments were retained in the analysis regardless of their level of group attendance.||units on a scale||Standard Deviation|Mean
733303|NCT00416598|Secondary|Relationship Between Busulfan Pharmacokinetics (Area Under the Curve) and Relapsed Disease|Results from busulfan pharmacokinetics will be pooled with those from CALGB 19808.|At baseline, after 2, 4, and 6 hours after the start of busulfan infusion||||||
733304|NCT00416598|Primary|Disease-free Survival (DFS) Rate at 1 Year|"For participants who achieved a complete remission (CR), this is the percentage of participants who were alive and relapse free at 1 year. The 1 year rate, with 95% confidence interval, was estimated using the Kaplan-Meier method
A CR is defined as those with > 20% cellularity of bone marrow biopsy, no presence of extramedullary leukemia for AML, <5 % myeloblast cells for bone marrow with peripheral blood and normal complete blood count (absolute neutrophils > 1000 mL and platelets >= 100,000 mL)."|At 1 year|||percentage of participants|||Number
733305|NCT00416598|Primary|Number of Participants Who Completed Maintenance Decitabine.|To determine feasibility of decitabine maintenance, this outcome measures the number of participants who completed all 8 planned cycles of decitabine maintenance as per protocol.|Up to 5 years|||participants|||Number
733306|NCT00416624|Secondary|Quality of Life as Measured by Symptom Distress Scale (SDS) Over All Follow-up Evaluations|To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule. SDS Scale range: 1 (No Symptom), 5 (Worst Symptom). Average scores across all time points for each item were calculated.|Weeks 4, 7, 10, 13 and 16|All patients that were evaluable per protocol with QOL data.||units on a scale||Standard Deviation|Mean
733307|NCT00416624|Secondary|Quality of Life as Measured by Brief Fatigue Inventory Overall All Follow-up Evaluations|To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule. Brief Fatigue Inventory (BFI) consist of 3 single-item numeric analogue scales on a scale of 0 to 10; and an interference scale formed by 6 single-item numeric scales on a scale of 0 to 10. Higher scores indicate fatigue as bad as you can imagine for fatigue now, usual fatigue and worse fatigue; and completely interferes for BFI interference. Average scores across all time points for fatigue now, usual fatigue, worst fatigue and BFI interference subscale were calculated.|Weeks 4, 7, 10, 13 and 16|All patients that were evaluable per protocol with QOL data.||units on a scale||Standard Deviation|Mean
734285|NCT00425308|Secondary|Assessing Cardiovascular Risk Factors Based on Fasting Total Cholesterol.|Blood chemistry - total cholesterol (mmol/L)|From Baseline to Month 1, 3, 6, 9, and 12|Safety population||mmol/L||Standard Deviation|Mean
733308|NCT00416624|Secondary|Quality of Life as Measured by Linear Analogue Self Assessment Over All Follow-up Evaluation|To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule. Linear Analogue Self Assessment (LASA) consists of 10 single-item numeric analogue scales on a scale of 0 to 10. Higher scores indicate better quality of life (QOL) on overall QOL, mental, physical, emotional spiritual QOL and Social activity; and constant pain, highest pain severity, level of fatigue and anxiety. Average scores across all time points for each item were calculated.|Weeks 4, 7, 10, 13 and 16|All patients that were evaluable per protocol with QOL data.||units on a scale||Standard Deviation|Mean
733309|NCT00416624|Secondary|Quality of Life as Measured by Functional Assessment of Cancer Therapy Scales for Anemia (FACT-AN) Over All Follow-up Evaluations|To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule. FACT-AN consist of Fatigue concerns subscale and non-fatigue concerns subscale. FACT Total Anemia score was calculated by adding the two subscales scores and transformed into 0-100 scale. FACT Total Anemia, Fatigue concerns scale and Non-Fatigue concerns scale are all ranges: 0 (Worst QOL) to 100 (Best QOL). Average scores across all time points for each subscale and total scale were calculated.|Weeks 4, 7, 10, 13 and 16|All patients that were evaluable per protocol with QOL data.||units on a scale||Standard Deviation|Mean
733310|NCT00416624|Secondary|The Percentage of Participants Reported Grade 3 or 4 Adverse Events|To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule. Adverse events were measured by Common Terminology Criteria for Adverse Events (CTCAE) v3.0.|16 weeks|All patients that were evaluable per protocol and reported at least one value after baseline.||percentage of participants|||Number
733311|NCT00416624|Secondary|The Percentage of Participants With Dose Omitted Due to Hematologic Reason|To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule|16 Weeks|All patients that were evaluable per protocol.||percentage of Participants|||Number
733312|NCT00416624|Secondary|The Total RBC Transfusion Needed|To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule|16 weeks|All patients that were evaluable per protocol and had RBC transfusions data.||g/dL||Standard Deviation|Mean
733313|NCT00416624|Secondary|The Percentage of Participants Requiring Red Blood Cell (RBC) Transfusions|To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule|16 weeks|All patients that were evaluable per protocol and had RBC transfusions data.||percentage of participants|||Number
733314|NCT00416624|Secondary|Mean Hemoglobin Change From Week 1 to Week 16|To compare the effects of the 3 different epoetin alfa dosing schedules and an every-3-weeks darbepoetin alfa schedule. The positive numbers represent hemoglobin increases and negative numbers represent hemoglobin decreases.|Week 1 and Week 16|All patients that were evaluable per protocol and had hemoglobin data.||g/dL||Standard Deviation|Mean
733315|NCT00416624|Secondary|Time Required to Achieve Hemoglobin Levels >= 11.5 g/dL|To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule|16 weeks|All patients that were evaluable per protocol and had hemoglobin levels data.||days||95% Confidence Interval|Median
733316|NCT00416624|Secondary|Weekly Change in Hemoglobin Levels|To compare the effects of the 3 different epoetin alfa dosing schedules and an every-3-weeks darbepoetin alfa schedule|Baseline and Week 4, 7, 10, 13, 16|All patients that were evaluable per protocol and had hemoglobin data at baseline, week 4, 7, 10, 13 or 16.||g/dL||Standard Deviation|Mean
733317|NCT00416624|Primary|The Percentage of Participants Who Exhibit a Hematopoietic Response|A hematopoietic response was defined as Hb rise >2 g/dL from baseline or achieving Hb ≥ 11.5 g/dL, whichever occurs first, in the absence of RBC transfusions within 14 days of measurement) during the treatment period|20 weeks|All patients that were evaluable per protocol.||Percentage of participants|||Number
733318|NCT00416715|Secondary|Letrozole Serum Levels Before and After Vitamin D Repletion|Letrezole serum level concentration in patients that were vitamin D deficient and experienced myalgias, arthralgias and/or joint stiffness.|Baseline and 1 month post vitamin D repletion|Only considering those patients who were baseline vitamin D deficient and experienced myalgias, arthralgias and/or joint stiffness.||micro-grams/mL||Inter-Quartile Range|Median
733319|NCT00416715|Primary|Number of Early Breast Cancer Patients Prescribed Adjuvant Letrozole That Are Vitamin D Deficient and Who Experience Myalgias, Arthralgias and/or Joint Stiffness|Count of early breast cancer patients prescribed adjuvant letrozole that are vitamin D deficient and who experience myalgias, arthralgias and/or joint stiffness, assessed at baseline and 1 month after vitamin D repletion.|Baseline and 1 month post vitamin D repletion|||Participants|||Count of Participants
733320|NCT00416793|Secondary|Overall Response Rate|Overall Response Rate measured by number of patients per the total treatment population who partially or completely responded to treatment. Participants reevaluated for response every 6 weeks. In addition to a baseline scan, confirmatory scans at 4 weeks following initial documentation of objective response.|Evaluated at end of every second 3 week cycle for response||||||
733321|NCT00416793|Primary|Overall Survival Rate at 6 Months|Overall survival (OS) at 6 months with the combination of bortezomib and carboplatin in participants who previously received 1 prior regimen for metastatic pancreatic cancer from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months. Rate equals number of participants living at 6 months following treatment divided by the total number of participants.|up to 6 months|Analysis was per protocol; Limited analysis due to study early termination.||Proportion of participants|||Number
733322|NCT00416884|Primary|Number of Participants With Treatment-related Mortality|Treatment related mortality is a consequence of both complications of the preparative regimen and systemic immunological rejection which is manifested as graft versus host disease(GVHD). The preparative regimens which include whole body radiation and/or high dose chemotherapy are complicated by single or multi-organ failure and by prolonged myelosuppression that can lead to infections and bleeding|lifetime followup, up to 100 years.|||Participants|||Number
733323|NCT00417027|Secondary|Overall Satisfaction Scores. Higher Scores Represent Greater Satisfaction With Analgesia During Labor and Delivery.|Patient satisfaction with analgesia management during labor and delivery. Scores are 0 to 100 with 0 complete dissatisfaction and 100 complete satisfaction with labor analgesia.|24 hours following labor analgesia|per protocal||Scores on a scale (0 toi 100)||Inter-Quartile Range|Median
734286|NCT00425308|Secondary|Assessing Cardiovascular Risk Factors Based on Fasting Glucose.|Blood chemistry - fasting glycemia (mmol/L)|From Baseline to Month 1, 3, 6, 9, and 12|Safety population||mmol/L||Standard Deviation|Mean
733324|NCT00417027|Secondary|Highest Thoracic Dermatome Sensory Level to Ice. Higher Levels Are Given by Lower Thoracic Vertebral Number.|Highest level of sensory loss to ice 3 hours after initiation of epidural analgesia. Thoracic dermatomes specify the level at which the nerves exit the spinal column. Higher thoracic spread of analgesia suggests greater dispersion of the epidural solution and may correlate with better analgesia. Higher levels are given by lower thoracic vertebral number. For example dermatome 4 has greater spread than dermatome 5.|3 hours after initiation of labor analgesia|||participants|||Number
733325|NCT00417027|Secondary|Manual Bolus Doses Administered||Duration of labor analgesia|||participants|||Number
733326|NCT00417027|Secondary|Number of Patient Controlled Bolus Doses of Bupivacaine/Fentanyl Administered|Patient controlled bolus of analgesic solution could be requested by activating a button. Bolus were 5ml of the epidural solution (bupivacaine 6.25mg/ml and fentanyl 1.96mgml). Patient requested administrations were allowed every 10 minutes to a maximum of 30 ml of epidural solution per hour.|Duration of labor analgesia|per protocal||participants||Inter-Quartile Range|Mean
733327|NCT00417027|Secondary|Patient Controlled Bolus Attempts|The number of attempted self administered bolus doses of epidural analgesia solution for control of pain.|Duration of labor analgesia|per protocal||number of bolus attempts||Inter-Quartile Range|Mean
733328|NCT00417027|Secondary|Area Under the Visual Analog Pain Scores (0 to 100mm) Per Hour of Labor Analgesia Curve|The pain burden calculated as the area under the visual analog pain scale (0 to 100 mm) patient self reported assessment of pain. Pain assessment were made at regular intervals during labor and the area under the pain score per time curve was calculated as the pain burden during labor. Greater pain would be indicated by a larger area. Possible range would be 0 for no pain to 100 for severe pain.|Duration of labor analgesia|per protocal||0 to 100 mm per hour||Inter-Quartile Range|Median
733329|NCT00417027|Primary|Total Bupivicaine in Milligrams Administered Per Hour of Labor for Analgesia.|Total bupivacaine from epidural solution administered for labor analgesia normalized per hour of labor.|From initiation of labor analgesia until delivery less than 24 hours|per protocal||mg bupivacaine per hour||Inter-Quartile Range|Median
733330|NCT00410761|Secondary|Time to Worsening of Pain (TWP)|TWP was derived using the worst pain score from brief pain inventory (BPI) and patient reported opioid analgesic use. BPI uses 0 to 10 numeric rating scales asking subjects to rate their pain.|During the last week of the screening period (Day -7 to Day 0), the brief pain inventory (BPI) and opioid analgesic use were self-reported once a day for 4 days to establish baseline, then every week during blinded study treatment, up to discontinuation.|||Weeks|||Number
733331|NCT00410761|Secondary|Biochemical Response Carcinoembryonic Antigen (CEA)|Best biochemical response was calculated from assessments at baseline and during treatment. Responders were those patients with a best biochemical response of CR or PR, confirmed by repeat assessments, which were to be performed no less than 4 weeks after the criteria for PR or CR were first met. CR and PR being defined according to level of CEA.|Blood samples for analysis of CEA were taken at screening baseline (average of 0, 1, 4 and 8 hours), then every 4 weeks until discontinuation and 60 day follow up|||Participants|||Number
733332|NCT00410761|Secondary|Biochemical Response Calcitonin (CTN)|Best biochemical response was calculated from assessments at baseline and during treatment. Responders were those patients with a best biochemical response of CR or PR, confirmed by repeat assessments, which were to be performed no less than 4 weeks after the criteria for PR or CR were first met. CR and PR being defined according to level of CTN.|Blood samples Blood samples for analysis of CTN were taken at screening baseline (average of 0, 1, 4 and 8 hours), then every 4 weeks until discontinuation and 60 day follow up|||Participants|||Number
733333|NCT00410761|Secondary|Overall Survival (OS)|As data was immature at data cut off, number of death events is quoted|Number of deaths since randomisation|||Participants|||Number
733334|NCT00410761|Secondary|Duration of Response (DoR)|Response is defined as a confirmed best objective response of CR or PR. Duration of response is defined as time from the date of first documented response until date of documented progression or death in the absence of disease progression (provided death is within 3 months of last RECIST assessment). Values are estimated as the medians weren't met|RECIST tumour assessments were performed at screening (within 3 weeks before date of randomisation), then once every 12 weeks up to and including discontinuation of blinded study treatment, unless patients had withdrawn consent|DoR is a time to event endpoint and because the medians were not met in this study there is no appropriate measure of dispersion of the median||Months||95% Confidence Interval|Median
733335|NCT00410761|Secondary|Disease Control Rate (DCR)|Disease control rate is defined as the number of patients who achieved disease control at 8 weeks following randomisation. Disease control at 8 weeks is defined as a best objective response of complete response (CR), partial response (PR) or stable disease (SD) >= 12 weeks|RECIST tumour assessments were performed at screening (within 3 weeks before date of randomisation), then once every 12 weeks up to and including discontinuation of blinded study treatment, unless patients had withdrawn consent|||Participants|||Number
733336|NCT00410761|Secondary|Objective Response Rate (ORR)|"The ORR is the number of patients that are responders ie those patients with a confirmed best objective response of complete response (CR) or partial response (PR) as defined by RECIST criteria.
The categories for best objective response are CR, PR, stable disease (SD)>= 12 weeks, progressive disease (PD) or NE."|RECIST assessments performed at screening (within 3 weeks before randomisation), then every 12 weeks. For patients with objective response of CR or PR, an additional confirmatory scan was performed ≥4 weeks following the date of first response.|||Participants|||Number
733337|NCT00410761|Primary|Progression-Free Survival(PFS)|Median time to progression (months) from randomisation until objective disease progression (determined by RECIST assessments) or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment. Values here are estimated (from a Weibull model) as the medians were not met.|RECIST tumour assessments were performed at screening (within 3 weeks before date of randomisation), then once every 12 weeks up to and including discontinuation of blinded study treatment, unless patients had withdrawn consent.|||Months||95% Confidence Interval|Median
733338|NCT00410813|Secondary|Mean Patient-reported Pain|"Patient's rating of worst pain experienced between prestudy and week 24. Changes of >=2 points on the Brief Pain Inventory (BPI) are of interest. Pain is self-reported on the Brief Pain Inventory Short Form, on a 0-10 response scale, with higher scores reflecting more pain and more interference with functioning."|Baseline, 8, 16, and 24 weeks|All patients with non-missing values were analyzed||units on a scale||Standard Deviation|Mean
733346|NCT00410813|Secondary|Circulating Tumor Cells (CTC) Response Rate|CTC response at 4 weeks is defined as the number of patients with initially elevated CTCs (>= 5 cells/7.5 ml), whose CTC level drops to < 5.|Up to 4 weeks|Treatment arms are combined in this analysis. Only eligible patients evaluated at both baseline and at 4 weeks were included. Patients analyzed for CTC response only includes patients who had elevated CTCs at baseline.||participants|||Number
733347|NCT00410813|Secondary|MUC-1 Antigen Response|MUC-1 Complete Response is reduction in MUC-1 such that MUC-1 <= ULN. MUC-1 Partial Response is greater than or equal to a 50% reduction in MUC-1 from baseline, but not qualifying as a CR. MUC-1 Progression is greater than or equal to a 50% increase in MUC-1 from baseline. MUC-1 Stable Disease is MUC-1 response not qualifying as CR, PR, or Progression.|at 4, 8, 16, and 24 weeks|MUC-1 Inadequate Assessment, response unknown: MUC-1 response has not been adequately assessed at indicated timepoints.|||||
733348|NCT00410813|Secondary|Response Rate (Complete and Partial, Confirmed and Unconfirmed)|Complete Response (CR) is complete disappearance of all measurable and non-measurable disease. No new lesions, no disease related symptoms, normalization of markers and other abnormal lab values. Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration. Progression is 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed, unequivocal progression of non-measurable disease, appearance of any new lesion/site, death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration is global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.|Up to 2 years|All eligible patients||participants|||Number
733349|NCT00410813|Primary|Progression-free Survival|RECIST progression defined as 20% increase in the sum of longest diameters of target measurable lesions over the smallest sum observed, unequivocal progression of non-measurable disease, the appearance of any new lesion/site, death due to disease without prior documentation of progression and without symptomatic deterioration, development of one or more new bone lesions from baseline, or symptomatic deterioration related to disease progression. Time from date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free are censored at last date of contact.|Up to 2 years|All eligible patients were included in this analysis.||weeks||95% Confidence Interval|Median
733350|NCT00417079|Secondary|Pain Response|Pain Response was defined as a two-point or greater reduction from baseline median Present Pain Intensity (PPI) score without an increased Analgesic Score (AS) or a decrease of ≥50% in the AS without an increase in the PPI score, maintained for at least 3 weeks.|from baseline up to 104 weeks (study cut-off)|Pain Response (applies only to patients, in the Intention-To-Treat (ITT) population, with median PPI ≥2 on McGill-Melzack scale and/or mean Analgesic Score ≥10 points at baseline)||Percentage of participants||95% Confidence Interval|Number
733351|NCT00417079|Secondary|Time to Pain Progression|"Pain Progression is defined as an increase of ≥1 point in the median Personal Pain Intensity (PPI) from its nadir noted on 2 consecutive 3-week-apart visits or ≥25 % increase in the mean analgesic score compared with the baseline score & noted on 2 consecutive 3-week-apart visits or requirement for local palliative radiotherapy.
Evaluation of the PPI & analgesic scores are based on the short-form McGill Pain Questionnaire which consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0=none (best) 1=mild 2=moderate 3=severe (worst) (TOTAL: 0=best 45=worst)"|from baseline up to 104 weeks (study cut-off)|Analysis was performed on the intention To Treat (ITT) population. Data from 265 and 279 patients in the cabazitaxel and mitoxantrone groups, respectively, were censored as a results of > 2 PPI and/or AS assessments being missed during the same week (unless a complete evaluation of ≥5 values showed pain progression).||Months||95% Confidence Interval|Median
733352|NCT00417079|Secondary|PSA (Prostate-Specific Antigen) Response|PSA response was defined as a ≥ 50% reduction in serum PSA, determined only for patients with a serum PSA ≥ 20ng/mL at baseline, confirmed by a repeat PSA ≥ 3 weeks later.|from baseline up to 104 weeks (study cut-off)|Prostate Specific Antigen (PSA) response was evaluated only in patients, in the Intention-To-Treat population, with a baseline PSA >20ng/mL.||Percentage of participants||95% Confidence Interval|Number
733353|NCT00417079|Secondary|Time to Prostatic Specific Antigen (PSA) Progression|"In PSA non-responders, progression will be defined as a 25% increase over nadir and increase in the absolute value PSA level by at least 5 ng/ml and confirmed by a second value at least 4 weeks later.
In PSA responders and in patients not evaluable for PSA response at baseline, progression will be defined as a ≥50% increase over nadir, provided that the increase is a minimum of 5 ng/ml and confirmed by a second value at least 1 week later."|at screening, day 1 of every treatment cycle, up to 104 weeks (study cut-off)|Analysis was performed on the intention To Treat (ITT) population. The ITT population is composed of all randomized patients (i.e. patients assigned to a treatment group by the randomization, regardless of whether patients received any study drug or received a different study drug from which they were randomized).||Months||95% Confidence Interval|Median
733354|NCT00417079|Secondary|Time to Tumor Progression|Time to tumor progression is defined as the number of months from randomization until evidence of progressive disease (RECIST)|From the date of randomization up to 104 weeks (study cut-off)|Analysis was performed on the intention To Treat (ITT) population. The ITT population is composed of all randomized patients (i.e. patients assigned to a treatment group by the randomization, regardless of whether patients received any study drug or received a different study drug from which they were randomized).||Months||95% Confidence Interval|Median
733355|NCT00417079|Secondary|Overall Tumor Response|"Tumor Overall Response Rate (ORR) (only in patients with measurable disease):
Objective responses (Complete Response and Partial Response) for measurable disease as assessed by investigators according to RECIST criteria.
Complete Response (CR) is defined as: Disappearance of all target lesions. Partial Response (PR) is defined as: At least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference baseline sum LD.
Confirmation of objective responses will be performed by repeat tumor imaging (CT scans, MRI, bone scans) after the first documentation of response."|From the date of randomization up to 104 weeks (study cut-off)|Tumor response rate was evaluated only for patients, in the Intention-To-Treat (ITT) population, with measurable disease by Response Evaluation Criteria in Solid Tumor (RECIST).||percentage of participants||95% Confidence Interval|Number
733356|NCT00417079|Secondary|Time to Progression Free Survival (PFS)|Progression free survival was defined as a composite endpoint evaluated from the date of randomization to the date of tumor progression, PSA progression, pain progression, or death due to any cause, whichever occurred first|From the date of randomization up to 104 weeks (study cut-off)|Analysis was performed on the intention To Treat (ITT) population. The ITT population is composed of all randomized patients (i.e. patients assigned to a treatment group by the randomization, regardless of whether patients received any study drug or received a different study drug from which they were randomized).||Months||95% Confidence Interval|Median
733357|NCT00417079|Primary|Overall Survival|"Overall survival was defined as the time interval from the date of randomization to the date of death due to any cause.
In the absence of confirmation of death, the survival time was censored at the last date patient was known to be alive or at the cut-off date, whichever had come first."|From the date of randomization up to 104 weeks (study cut-off)|Analysis was performed on the intention To Treat (ITT) population. The ITT population is composed of all randomized patients (i.e. patients assigned to a treatment group by the randomization, regardless of whether patients received any study drug or received a different study drug from which they were randomized).||Months||95% Confidence Interval|Median
733358|NCT00417170|Secondary|Mean Change in Arterial Compliance as Measured by Pulse Wave Analysis From Baseline and After 12 Weeks of Treatment|Arterial Compliance is determined by Pulse Wave Analysis measured by a detector placed at the carotid artery while taking ECG and tonometry at the same time. Procedure is repeated for the femoral artery. Pulse Wave data are calculated by dividing distance between 2 arteries by the difference between the rise delay of the distal pulse wave and the R wave of the QRS complex and the rise delay of the proximal pulse wave to the QRS complex. Data analysis used an analysis of variance (ANOVA) model including treatment and week as fixed factors and subject (nested in treatment) as a random factor.|At baseline and after 12 weeks of treatment|The Pharmacodynamic (PD) analysis set includes all participants with available PD data and no major protocol deviation with impact on PD data. Participants with observations at both baseline and endpoint were included in the analysis.||mmHg||Standard Error|Least Squares Mean
733359|NCT00417170|Secondary|Mean Change From Baseline in Inflammatory Marker ( C-peptide) as Measured During Oral Glucose Tolerance Test (OGTT) From Baseline and After 12 Weeks of Treatment [Time Frame: At Baseline and After 12 Weeks of Treatment|C-peptide level is determined by the Oral Glucose Tolerance Test (OGTT) which begins after a 10 hour overnight fast. Blood samples are taken at baseline and after an oral 75 gram dose of glucose. Additional samples of blood are taken to measure glucose and insulin levels at 30, 60, 120 and 180 minutes post glucose intake. Changes from pre-glucose intake values are analyzed by an analysis of variance (ANOVA) model including treatment, visit and post-dose time points ( 30, 60, 120 and 180 minutes) as fixed factors and subject (nested in treatment) as a random factor.|Baseline and after 12 weeks of treatment|The PD analysis set included all subjects with available PD data and no major protocol deviations with impact on PD data. During different time points, participants with observations at that time point were included in the analysis.||ng/mL||Standard Error|Least Squares Mean
733360|NCT00417170|Secondary|Mean Change in Insulin Concentration as Measured During Oral Glucose Tolerance Test (OGTT) From Baseline and After 12 Weeks of Treatment|Insulin Concentration is determined by the Oral Glucose Tolerance Test (OGTT) which begins after a 10 hour overnight fast. Blood samples are taken at baseline and after an oral 75 gram dose of glucose. Additional samples of blood are taken to measure glucose and insulin levels at 30, 60, 120 and 180 minutes post glucose intake. Changes from pre-glucose intake values are analyzed by an analysis of variance (ANOVA) model including treatment, visit and post-dose time points ( 30, 60, 120 and 180 minutes) as fixed factors and subject (nested in treatment) as a random factor.|At baseline and after 12 weeks of treatment|The Pharmacodynamic (PD) analysis set included all participants with available PD data and no major protocol deviation with impact on PD data. During different time points, participants with observations at that time point were included in the analysis.||mU/L||Standard Error|Least Squares Mean
733361|NCT00417170|Secondary|Mean Change in Insulin Sensitivity as Measured by Glucose Infusion Rate (Last 30 Minutes) From Baseline and After 12 Weeks of Treatment.|Insulin sensitivity is measured by the hyperglycemic euglycemic clamp procedure where a supine patient has 2 IV lines inserted for sampling blood. Regular human insulin (60mU/m^2 surface area/min) is infused for 120 minutes. Dextrose (20% w/v) is infused to maintain glycemia at < 100 mg/dL and is adjusted based on plasma glucose levels obtained every 5 minutes. Blood for glucose and insulin is taken at specified time intervals. Change from baseline data is analyzed by analysis of variance model including treatment and week as fixed factors, and subject (nested in treatment) as a random factor.|At baseline and after 12 weeks of treatment|The Pharmacodynamic (PD) analysis set includes all participants with available PD data and no major protocol deviation with impact on PD data. Participants with observations at both baseline and endpoint were included in the analysis.||mg/kg/min||Standard Error|Least Squares Mean
733362|NCT00417170|Primary|Mean Change in Endothelial Function as Measured by Myocardial Blood Flow (MBF) From Baseline and After 12 Weeks of Treatment|MBF is measured by Positron Emission Tomography (PET) first at rest, then 45 minutes later, during cold pressor testing (CPT). The patient is placed in the PET scanner and injected with N-13 ammonia as a tracer. PET images are taken to assess myocardial blood flow at rest. After 40 minutes, the patient immerses one hand in ice water and PET images are taken to assess myocardial blood flow at sympathetic activation. Change from baseline data is analyzed by an analysis of variance (ANOVA) model including treatment and week as fixed factors and subject (nested in treatment) as a random factor.|At baseline and after 12 weeks of treatment|The Pharmacodynamic (PD) analysis set includes all participants with available PD data and no major protocol deviation with impact on PD data. Participants with observations at both baseline and endpoint were included in the analysis.||mL/g/min||Standard Error|Least Squares Mean
733363|NCT00417248|Secondary|Overall Survival||18 months|Data for this outcome measure was not collected or analyzed due to the early termination of the study.|||||
733364|NCT00417248|Primary|Time to Disease Progression (TTP)||18 months|The primary objective for this study was not analyzed due to termination of the study. No participants were on-study for a sufficient period of time to collect or analyze the time to disease progression data.|||||
733365|NCT00417274|Primary|Efficacy of Quinacrine, Based on Prostate Specific Antigen (PSA) Response in Patients With Androgen-independent Metastatic Prostate Cancer|Patients who achieved a complete response (CR) or a partial response (PR) to therapy were allowed to continue to receive treatment until disease progression or unacceptable toxicity occurred, until the patient discontinued treatment for another reason, or for a total of 6 months. Patients who continued to show a CR or PR or who maintained stable disease (SD) after 6 months of therapy were to be allowed to continue therapy at the investigator’s discretion.|End of treatment|Based on clinical judgment||Participants|||Number
733366|NCT00419926|Primary|Number of Patients With Treatment Failure 6-months Post Transplant Measured by the Combined Incidence of Biopsy Proven Acute Rejection, Graft Loss, and Death|To evaluate therapeutic benefit by comparing the efficacy defined as the number of participants with treatment failure (biopsy-proven acute rejection [BPAR], graft loss [GFL] or death) at 6 months post-transplant. BPAR was defined as a biopsy graded IA, IB, IIA, IIB or III using Banff 2000 classification. A graft core biopsy was performed within 24 hours of initiation of anti-rejection therapy. GFL was defined as the day the allograft was presumed lost (the day the patient started dialysis, the day of nephrectomy or the day of irreversible graft loss demonstrated by imaging techniques.)|6 months|Per Protocol (PP) population.||number of participants|||Number
733367|NCT00419926|Secondary|Renal Function Assessed by Serum Creatinine at Each Visits||at 21 days, 84 days and 180 days||||||
733368|NCT00419926|Secondary|Renal Function Assessed by Glomerular Filtration Rate (GFR)at Each Visit|The Modification of Diet in Renal Disease (MDRD) formula was used to calculate the GFR. Serum creatinine levels, age, sex and race were used to estimate the GFR levels in mL/min/1.73m^2.|at 21 days, 84 days and 180 days|Intention to treat (ITT) population.||(mL/min/1.73m^2)||Standard Deviation|Mean
733369|NCT00419926|Secondary|Comparison of Overall Treatment Failure at Days 21 and 84 Post-transplantation Assessed by Biopsy Proven Acute Rejection (BPAR), GFL, and Death|The overall treatment differences of the number of participants with at least one occurrence of the composite event BPAR, GFL or death at study days 21 and 84 post-transplantation. BPAR was defined as a biopsy graded IA, IB, IIA, IIB or III using Banff 2000 classification. A graft core biopsy was performed within 24 hours of initiation of anti-rejection therapy. GFL was defined as the day the allograft was presumed lost (the day the patient started dialysis, the day of nephrectomy or the day of irreversible graft loss demonstrated by imaging techniques.)|21 and 84 days|Per Protocol (PP) population.||number of participants|||Number
733370|NCT00419926|Secondary|Comparison of Overall Treatment Failure at Days 21 and 84 Post-transplantation Assessed by Biopsy Proven Acute Rejection (BPAR), GFL, and Death|The overall treatment differences of the number of participants with at least one occurrence of the composite event BPAR, GFL or death at study days 21 and 84 post-transplantation. BPAR was defined as a biopsy graded IA, IB, IIA, IIB or III using Banff 2000 classification. A graft core biopsy was performed within 24 hours of initiation of anti-rejection therapy. GFL was defined as the day the allograft was presumed lost (the day the patient started dialysis, the day of nephrectomy or the day of irreversible graft loss demonstrated by imaging techniques.)|21 and 84 days|Intention to treat (ITT) population.||number of participants|||Number
733371|NCT00419926|Primary|Number of Patients With Treatment Failure 6-months Post Transplant Measured by the Combined Incidence of Biopsy Proven Acute Rejection, Graft Loss, and Death|To evaluate therapeutic benefit by comparing the efficacy defined as the number of participants with treatment failure (biopsy-proven acute rejection [BPAR], graft loss [GFL] or death) at 6 months post-transplant. BPAR was defined as a biopsy graded IA, IB, IIA, IIB or III using Banff 2000 classification. A graft core biopsy was performed within 24 hours of initiation of anti-rejection therapy. GFL was defined as the day the allograft was presumed lost (the day the patient started dialysis, the day of nephrectomy or the day of irreversible graft loss demonstrated by imaging techniques.)|6 months|Intention to treat (ITT) population.||number of participants|||Number
733372|NCT00419952|Secondary|Asthma Treatment Satisfaction Measure (ATSM)|Overall score - change from baseline to end of treatment. For 11 individual attributes, expectations were subtracted from the outcomes. This difference and the importance rating were combined in a weighted average which was then multiplied by the raw satisfaction measure. The final derived satisfaction measure was transformed to a 0 to 100 scale, with higher scores representing greater satisfaction.|Baseline and 52 weeks|The full analysis set, consisting of all randomized patients who received at least one dose of randomized study medication and for whom data were collected after randomization.||units on a scale||95% Confidence Interval|Least Squares Mean
733373|NCT00419952|Secondary|Forced Expiratory Volume in One Second (FEV1)|Change in pre-dose FEV1 from baseline (end of run-in, visit 3) to the average of the randomized treatment period|baseline and 52 weeks|The full analysis set, consisting of all randomized patients who received at least one dose of randomized study medication and for whom data were collected after randomization.||Litres||95% Confidence Interval|Least Squares Mean
733374|NCT00419952|Secondary|Peak Expiratory Flow (PEF) in Morning|Change in AM PEF from baseline (mean over the 2 weeks run-in) to the average of the randomized treatment period.|baseline and 52 weeks|The full analysis set, consisting of all randomized patients who received at least one dose of randomized study medication and for whom data were collected after randomization.||Liters/minute||95% Confidence Interval|Least Squares Mean
733375|NCT00419952|Secondary|Onset of Effect Questionnaire (OEQ)|Number of participants with positive response to Item 5 in questionnaire “During the past week, you were satisfied with how quickly you felt your study medication begin to work.” The scale was scored on a 5-point Likert scale from strongly agree to strongly disagree. A positive response was defined as a response of “strongly agree” or “somewhat agree”|1 week|The full analysis set, consisting of all randomized patients who received at least one dose of randomized study medication and for whom data were collected after randomization.||Participants|||Number
733376|NCT00419952|Secondary|Onset of Effect Questionnaire (OEQ)|Number of participants with positive response to Item 2 in questionnaire “During the past week,you could feel your study medication begin to work right away. A positive response was defined as a response of “strongly agree” or “somewhat agree”|1 week|The full analysis set, consisting of all randomized patients who received at least one dose of randomized study medication and for whom data were collected after randomization.||Participants|||Number
733755|NCT00422383|Secondary|Percentage of Participants With Complement Component 3 (C3) Protein Level ≤ LLN|The LLN for C3 protein was defined as <0.9 grams per liter (g/L).|BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint||percentage of participants|||Number
733377|NCT00419952|Secondary|Diary Assessments - Asthma-control Day|Calculated as the number of asthma control days divided by the number of non missing days in the baseline period times 100%. The results are expressed as the change in % asthma control days in the baseline period and the active treatment period. An asthma control day was one in which the patient answered “no” to having symptoms and “0” to the use of rescue medication that day|baseline and 52 weeks|The full analysis set, consisting of all randomized patients who received at least one dose of randomized study medication and for whom data were collected after randomization.||percentage of Asthma-control day||95% Confidence Interval|Least Squares Mean
733378|NCT00419952|Secondary|Diary Assessments - Symptom-free Day|Calculated as the number of symptom-free days divided by the number of non missing days in the baseline period times 100%. The results are expressed as the change in % symptom-free days in the baseline period and the active treatment period. A symptom-free day was one in which the patient answered “no” to having symptoms that day|baseline and 52 weeks|The full analysis set, consisting of all randomized patients who received at least one dose of randomized study medication and for whom data were collected after randomization.||percentage of Symptom-free day||95% Confidence Interval|Least Squares Mean
733379|NCT00419952|Secondary|Diary Assessments - Rescue-free Day|Calculated as the number of rescue-free days divided by the number of non missing days in the baseline period times 100%. The results are expressed as the change in % rescue-free days in the baseline period and the active treatment period. A rescue-free day was one in which the patient answered “no” to having used rescue medication that day|baseline and 52 weeks|The full analysis set, consisting of all randomized patients who received at least one dose of randomized study medication and for whom data were collected after randomization.||Percentage of Rescue Free Day||95% Confidence Interval|Least Squares Mean
733380|NCT00419952|Secondary|Total Number of Ventricular Runs as Measured by 24-hour Holter Monitor Assessment|Total ventricular runs – number of participants with shift normal (<1) to high (≥1) from baseline to week 2.|Baseline and 2 weeks (visit 4)|Data were available for a subset of patients.||Participants|||Number
733381|NCT00419952|Secondary|Number of Patients With Shift From Normal to High Rate of Total Ectopic Supraventricular Beats as Measured by 24-hour Holter Monitor Assessment|Total ectopic supraventricular (VE) beats – number of participants with shift normal (<50) to high (≥50) from baseline to visit 4.|Baseline and 2 weeks (visit 4)|Data were available for a subset of patients||Participants|||Number
733382|NCT00419952|Secondary|Number of Patients With Shift From Normal to High Rate of Total Ectopic Ventricular Beats as Measured by 24-hour Holter Monitor Assessment|Total ectopic ventricular (VE) beats – number of participants with shift from normal (<50) to high (≥50) from baseline to visit 4.|Baseline and 2 weeks (visit 4)|Data were available for a subset of patients.||Participants|||Number
733383|NCT00419952|Secondary|QT Interval Corrected Using the Fridericia Formula Measured Via Electrocardiogram (ECG)|QT interval corrected using the Fridericia formula [QTc (Frid)] – Change from baseline to end of treatment|Baseline and 52 weeks|The full analysis set, consisting of all randomized patients who received at least one dose of randomized study medication and for whom data were collected after randomization.||msec||95% Confidence Interval|Least Squares Mean
733384|NCT00419952|Secondary|Asthma Exacerbations|Number of participants with at least 1 exacerbation|52 Weeks|The full analysis set, consisting of all randomized patients who received at least one dose of randomized study medication and for whom data were collected after randomization.||Participants|||Number
733385|NCT00419952|Primary|Total Number of Asthma Exacerbations|An exacerbation was defined as symptomatic worsening requiring oral/systemic glucocorticoid therapy and/or emergency room visit and/or urgent care center visit and/or hospitalization.|52 Weeks|The full analysis set, consisting of all randomized patients who received at least one dose of randomized study medication and for whom data were collected after randomization.||Exacerbations|||Number
733386|NCT00420017|Secondary|Number of Participants With Adverse Effects|Adverse effects, including cardiovascular (hypotension, bradycardia, prolonged QT interval, ventricular tachycardia), respiratory (ARDS, pneumonia, atelectasis), and other (pericardial effusions, anastomotic leak)|7 days|Per protocol||patients|||Number
733387|NCT00420017|Secondary|Length of Post-surgical Intensive Care Unit Stay||7 days|||hours||Inter-Quartile Range|Median
733388|NCT00420017|Secondary|Length of Post-surgical Hospital Stay||Duration of hospitalization|||days||Inter-Quartile Range|Median
733389|NCT00420017|Primary|Incidence of Atrial Fibrillation||7 days|Analysis was per protocol||participants|||Number
733390|NCT00420056|Secondary|Correlation Coefficient Between Plasma PD 0332991 Concentration and Change From Baseline in Biomarkers and SUVmax at Cycle 1 Day 21|Plasma PD 0332991 concentration at Cycle 1 Day 21 was analyzed. Change from baseline in biomarkers (Ki-67 composite score, Cyclin D1 composite score, phospho-Rb positive cells) and SUVmax (FLT-PET SUVmax, FDG-PET SUVmax) at Cycle 1 Day 21 were analyzed. Correlation between PD 0332991 concentration and change in biomarkers (concentration versus Ki-67, concentration versus Cyclin, and concentration versus phospho-Rb) and SUVmax (concentration versus FLT-PET SUVmax, concentration versus FDG-PET SUVmax) was then assessed. Composite score = (sum of each intensity category multiplied by percent of cells in that category). Intensity categories of staining (0 = no staining; 1 = weak staining; 2 = moderate staining; 3 = strong staining). Here, ‘N’ (number of participants analyzed) signifies participants evaluable for this measure.|Baseline, Cycle 1 Day 21|PD 0332991 concentration was analyzed using pharmacokinetic analysis set (participants in FAS who had also completed pharmacokinetic blood sampling for at least 1 day); SUVmax and biomarkers were analyzed using imaging analysis set and tumor analysis set respectively. n= participants evaluable for this measure for specified comparisons.||correlation coefficient|||Number
733391|NCT00420056|Secondary|Time to Tumor Progression (TTP)|Time in months from date of first dose of study medication to first documentation of objective tumor progression (PD). TTP= (last known progression-free date minus date of first dose of study medication plus 1) divided by 30.44. PD was defined as greater than 50% increase in sum of products of diameters, of dominant nodes and documented non-nodal sites or appearance of new sites of disease.|Screening until tumor progression or death, assessed on Day 1 of every alternate cycle starting from Cycle 1 up to end of treatment (Day 609) or early withdrawal (if not completed during last 6 weeks)|Response analysis set included all participants enrolled in the study who received at least 1 dose of study medication in cycle 1 and for whom a post-treatment response assessment was completed.||months||95% Confidence Interval|Median
733392|NCT00420056|Secondary|Duration of Response (DR)|Time in months from first documentation of objective tumor response (CR or PR) that was subsequently confirmed, to objective tumor progression (PD) or death due to any cause. DR= (date of first documentation of PD or death, minus the date of first CR or PR plus 1) divided by 30.44. CR= disappearance of all detectable clinical/radiographic evidence of disease, disease related symptoms present before start of therapy and biochemical abnormalities attributable to disease, nodal masses regressed to normal size, if spleen and bone marrow were involved, spleen regressed to normal size and not palpable and clear infiltrate on repeated bone marrow aspiration. PR= dominant nodes decreased by >50% in sum of products of diameters (SPD), no increase in size of other nodes/liver/spleen, lesions in organs (spleen/liver) regressed by >50% in SPD, no new sites of disease. PD= >50% increase in SPD of dominant nodes and other nodes or appearance of new sites of disease.|Screening until tumor progression or death, assessed on Day 1 of every alternate cycle starting from Cycle 1 up to end of treatment (Day 609) or early withdrawal (if not completed during last 6 weeks)|For duration of response, the number of participants experiencing objective response was less than 50%, and therefore, it was not feasible to calculate duration of response using Kaplan-Meier method. Hence, no participant was analyzed for this outcome measure.|||||
733393|NCT00420056|Secondary|Percentage of Participants With Objective Response|OR is defined as the percentage of participants with confirmed complete response (CR) or confirmed partial response (PR). Confirmed responses are those that persist on repeat imaging study 4 weeks after initial documentation of response. Complete response (CR)= disappearance of all detectable clinical/radiographic evidence of disease, disease related symptoms present before therapy and biochemical abnormalities attributable to disease, nodal masses regressed to normal size, if spleen and bone marrow were involved, spleen regressed to normal size and not palpable and clear infiltrate on repeated bone marrow aspiration; Partial response (PR)= dominant nodes decreased by >50% in sum of products of diameters (SPD), no increase in size of other nodes/liver/spleen, lesions in organs (spleen/liver) regressed by >50% in SPD, no new sites of disease.|Screening until tumor progression or death, assessed on Day 1 of every alternate cycle starting from Cycle 1 up to end of treatment (Day 609) or early withdrawal (if not completed during last 6 weeks)|Response analysis set included all participants enrolled in the study who received at least 1 dose of study medication in cycle 1 and for whom a post-treatment response assessment was completed.||percentage of participants||95% Confidence Interval|Number
733394|NCT00420056|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time from first dose of study medication to the first documentation of objective tumor progression, or to death due to any cause, whichever occurred first. Tumor progression was defined as >50% increase in sum of products of diameters, of dominant nodes and documented non-nodal sites or appearance of new sites of disease. PFS= (first event date minus the first dose date plus 1) divided by 30.44.|Screening until tumor progression or death, assessed on Day 1 of every alternate cycle starting from Cycle 1 up to end of treatment (Day 609) or early withdrawal (if not completed during last 6 weeks)|Response analysis set included all participants enrolled in the study who received at least 1 dose of study medication in cycle 1 and for whom a post-treatment response assessment was completed.||months||95% Confidence Interval|Median
733395|NCT00420056|Primary|Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The events which were considered treatment-related by sponsor and/or investigator were reported.|Day 1 up to 28 days after last dose of study medication|Safety analysis set included all participants enrolled in the study who received at least 1 dose of study medication.||participants|||Number
733396|NCT00420056|Primary|Number of Participants With Treatment-Emergent Adverse Events by Severity|AE = any untoward medical occurrence in participant who received study medication without regard to possibility of causal relationship. Severity was assessed as: Grade 1 (Mild); Grade 2 (Moderate); Grade 3 (Severe) = unacceptable or intolerable events, significantly interrupting usual daily activity, and requiring systemic medication therapy/other treatment; Grade 4 (Life-threatening) = events causing participant to be in imminent danger of death; Grade 5 (Death) = death related to an AE. Treatment-emergent events = between first dose of study medication and up to 28 days after last dose, that were absent before treatment or that worsened relative to pre-treatment state. A participant may be represented in more than 1 category.|Day 1 up to 28 days after last dose of study medication|Safety analysis set included all participants enrolled in the study who received at least 1 dose of study medication.||participants|||Number
733397|NCT00420056|Primary|Number of Participants With Laboratory Test Abnormalities|Criteria for laboratory test abnormality: Hematology (Hemoglobin [<0.8*lower limit of normal {LLN}], Platelets [<0.5*LLN/ >1.75*upper limit of normal {ULN}], White blood cells [<0.6*LLN/ >1.5*ULN], Lymphocytes, Neutrophils [<0.8*LLN/ >1.2*ULN], Basophils, Eosinophils, Monocytes [>1.2*ULN]); Liver Function (Total bilirubin [>1.5*ULN], Aspartate aminotransferase, Alanine aminotransferase, Lactate dehydrogenase, Alkaline phosphatase [>0.3*ULN], Total protein, Albumin [<0.8*LLN/ >1.2*ULN]); Renal Function (Blood urea nitrogen, Creatinine [>1.3*ULN], Uric acid [>1.2*ULN]); Electrolytes (sodium [<0.95*LLN/ >1.05*ULN], potassium, chloride, calcium, magnesium [<0.9*LLN/ >1.1*ULN], phosphate [<0.8*LLN/ >1.2*ULN]); Other (Glucose [<0.6*LLN/ >1.5*ULN]).|Baseline up to 28 days after last dose of study medication|Safety analysis set included all participants enrolled in the study who received at least 1 dose of study medication.||participants|||Number
733398|NCT00420056|Primary|Cyclin D1 Composite Score at Cycle 1 Day 21|Percentage of Cyclin D1 positive cells was determined by Immunohistochemical staining technique. Composite score = (sum of each intensity category multiplied by percent of cells in that category). Intensity categories of staining (0 = no staining; 1 = weak staining; 2 = moderate staining; 3 = strong staining). Composite score ranges from 0 (no staining) to 300 (100% of cells with 3 staining intensity).|Cycle 1 Day 21|Tumor analysis set include all participants in FAS who completed tumor biomarker assessments at baseline and Day 21. Here, ‘N’ (number of participants analyzed) signifies participants evaluable for this measure.||units on a scale||Standard Deviation|Mean
733399|NCT00420056|Primary|Cyclin D1 Composite Score at Baseline|Percentage of Cyclin D1 positive cells was determined by Immunohistochemical staining technique. Composite score = (sum of each intensity category multiplied by percent of cells in that category). Intensity categories of staining (0 = no staining; 1 = weak staining; 2 = moderate staining; 3 = strong staining). Composite score ranges from 0 (no staining) to 300 (100% of cells with 3 staining intensity).|Baseline|Tumor analysis set include all participants in FAS who completed tumor biomarker assessments at baseline and Day 21. Here, ‘N’ (number of participants analyzed) signifies participants evaluable for this measure.||units on a scale||Standard Deviation|Mean
733400|NCT00420056|Primary|Ki-67 Composite Score at Cycle 1 Day 21|Percentage of Ki-67 positive cells was determined by Immunohistochemical staining technique. Composite score = (sum of each intensity category multiplied by percent of cells in that category). Intensity categories of staining (0 = no staining; 1 = weak staining; 2 = moderate staining; 3 = strong staining). Composite score ranges from 0 (no staining) to 300 (100% of cells with 3 staining intensity).|Cycle 1 Day 21|Tumor analysis set include all participants in FAS who completed tumor biomarker assessments at baseline and Day 21. Here, ‘N’ (number of participants analyzed) signifies participants evaluable for this measure.||units on a scale||Standard Deviation|Mean
733401|NCT00420056|Primary|Ki-67 Composite Score at Baseline|Percentage of Ki-67 positive cells was determined by Immunohistochemical staining technique. Composite score = (sum of each intensity category multiplied by percent of cells in that category). Intensity categories of staining (0 = no staining; 1 = weak staining; 2 = moderate staining; 3 = strong staining). Composite score ranges from 0 (no staining) to 300 (100% of cells with 3 staining intensity).|Baseline|Tumor analysis set include all participants in FAS who completed tumor biomarker assessments at baseline and Day 21. Here, ‘N’ (number of participants analyzed) signifies participants evaluable for this measure.||units on a scale||Standard Deviation|Mean
733402|NCT00420056|Primary|Phosphorylated Retinoblastoma (Phospho-Rb) Percent Positive Cells at Cycle 1 Day 21|Phosphorylation of retinoblastoma (Rb) protein in the tumor cells, expressed as phospho-Rb percent positive cells, was assessed using Immunohistochemical staining technique.|Cycle 1 Day 21|Tumor analysis set include all participants in FAS who completed tumor biomarker assessments at baseline and Day 21. Here, ‘N’ (number of participants analyzed) signifies participants evaluable for this measure.||percentage of tumor cells||Standard Deviation|Mean
733403|NCT00420056|Primary|Phosphorylated Retinoblastoma (Phospho-Rb) Percent Positive Cells at Baseline|Phosphorylation of retinoblastoma (Rb) protein in the tumor cells, expressed as phospho-Rb percent positive cells, was assessed using Immunohistochemical staining technique.|Baseline|Tumor analysis set include all participants in FAS who completed tumor biomarker assessments at baseline and Day 21. Here, ‘N’ (number of participants analyzed) signifies participants evaluable for this measure.||percentage of tumor cells||Standard Deviation|Mean
733404|NCT00420056|Primary|Correlation Between Positron Emission Tomography (PET) Response and Objective Response (OR)|OR: CR= disappearance of all clinical/radiographic evidence of disease, disease related symptoms and biochemical abnormalities, nodal masses regressed to normal size, if spleen and bone marrow were involved, spleen regressed to normal size and not palpable and clear infiltrate on repeat bone marrow aspiration; PR= dominant nodes decreased by >50% in sum of products of diameters (SPD), no increase in size of other nodes/liver/spleen, lesions regressed by >50% in SPD, no new sites of disease; SD= response <PR and no PD, documented >=1 time after start of therapy, no new sites of disease; PD= >50% increase in SPD of dominant nodes and other nodes or appearance of new sites of disease. PET response: CR= mean SUVmax same as background; PR= mean SUVmax <75% of baseline; PD= mean SUVmax >125% of baseline; SD= mean SUVmax >=75% of baseline but <=125% of baseline. Correlation was reported as conjoint number of participants with PET response at Cycle 1 Day 21 and OR at end of study.|Baseline, Cycle 1 Day 21 for PET response; Screening until tumor progression or death, assessed on Day 1 of every alternate cycle starting from Cycle 1 up to end of treatment (Day 609) or early withdrawal (if not completed during last 6 weeks) for OR|PET response was analyzed using Imaging analysis set and OR was analyzed using response analysis set (all participants enrolled in the study who received at least 1 dose of study medication in cycle 1 and for whom a post-treatment response assessment was completed).||participants|||Number
733405|NCT00420056|Primary|Correlation Between Positron Emission Tomography (PET) Response and Progression-Free Survival (PFS)|PET response was defined as complete response (CR) = mean SUVmax same as of background; partial response (PR) = mean SUVmax less than (<) 75 percent (%) of baseline; progressive disease (PD) = mean SUVmax greater than (>) 125% of baseline; stable disease (SD) = mean SUVmax greater than or equal to (>=) 75% of baseline and mean SUVmax less than or equal to (<=) 125% of baseline. PFS was defined as the time from first dose of study medication to the first documentation of objective tumor progression, or to death due to any cause, whichever occurred first. Tumor progression was defined as >50% increase in sum of products of diameters, of dominant nodes and documented non-nodal sites or appearance of new sites of disease.|Baseline, Cycle 1 Day 21 for PET response; Screening until tumor progression or death, assessed on Day 1 of every alternate cycle starting from Cycle 1 up to end of treatment (Day 609) or early withdrawal (if not completed during last 6 weeks) for PFS|Analysis for this outcome measure was not run as there were so few responders.|||||
733406|NCT00420056|Primary|Change From Baseline in Maximum Standard Uptake Value (SUVmax) at Cycle 1 Day 21|Maximum standard uptake value (SUVmax) was defined as the maximum value attained for the ratio of tissue radioactivity concentration at any time and the injected radioactivity concentration divided by the body weight (in kilogram [kg]). Change from baseline in SUVmax was assessed using [(18)F]-FLT-PET and [(18)F]-FDG-PET techniques.|Baseline, Cycle 1 Day 21|Imaging analysis set included participants in FAS who completed baseline [(18)F]-FDG-PET and [(18)F]-FLT-PET, and at least 1 on-treatment (Day 21) PET.||standard uptake value (SUV)||Standard Deviation|Mean
733418|NCT00420199|Secondary|Double-blind Period: Number of Participants With Positive Antibodies to Abatacept by Electrochemiluminescence (ECL) Assay|On-Rx=on treatment; post-Rx=post treatment. ECL screened sera for drug-specific antibodies; immunocompetition was used to identify specific anti-Abatacept reactivity. Cytotoxic leukocyte antigen 4 (CTLA4) and Possibly Immunoglobulin (Ig) Category=reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction Category=reactivity against constant regions and/or hinge region of human IgG1.|Day 1 to Day 113|All randomized participants who received at least 1 dose of study medication.||participants|||Number
733407|NCT00420056|Primary|Correlation Coefficient Between Change From Baseline in Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) Maximum Standard Uptake Value (SUVmax) and in Phosphorylated Retinoblastoma (Phospho-Rb) Percent Positive Cells at Cycle 1 Day 21|Maximum standard uptake value (SUVmax) was defined as the maximum value attained for the ratio of tissue radioactivity concentration at any time and the injected radioactivity concentration divided by the body weight (in kilogram [kg]). Phosphorylation of retinoblastoma (Rb) protein in the tumor cells, expressed as phospho-Rb percent positive cells, was assessed using Immunohistochemical staining technique. Change from baseline in [(18)F]-FDG-PET SUVmax at Cycle 1 Day 21 and change from baseline in Phospho-Rb percent positive cells at Cycle 1 Day 21 were analyzed. The change values of FLT-PET SUVmax and Phospho-Rb percent positive cells were then correlated. Here, ‘N’ (number of participants analyzed) signifies participants evaluable for this measure.|Baseline, Cycle 1 Day 21|SUVmax was analyzed using imaging analysis set (participants in FAS who completed baseline [(18)F]-FDG-PET and [(18)F]-FLT-PET, and at least 1 on-treatment [Day 21] PET) and phospho-Rb was analyzed using tumor analysis set (participants in FAS who completed tumor biomarker assessments at baseline and Day 21).||correlation coefficient|||Number
733408|NCT00420056|Primary|Correlation Coefficient Between Change From Baseline in Fluoro-L-thymidine Positron Emission Tomography (FLT-PET) Maximum Standard Uptake Value (SUVmax) and in Phosphorylated Retinoblastoma (Phospho-Rb) Percent Positive Cells at Cycle 1 Day 21|Maximum standard uptake value (SUVmax) was defined as the maximum value attained for the ratio of tissue radioactivity concentration at any time and the injected radioactivity concentration divided by the body weight (in kilogram [kg]). Phosphorylation of retinoblastoma (Rb) protein in the tumor cells, expressed as phospho-Rb percent positive cells, was assessed using Immunohistochemical staining technique. Change from baseline in [(18)F]-FLT-PET SUVmax at Cycle 1 Day 21 and change from baseline in Phospho-Rb percent positive cells at Cycle 1 Day 21 were analyzed. The change values of FLT-PET SUVmax and Phospho-Rb percent positive cells were then correlated. Here, ‘N’ (number of participants analyzed) signifies participants evaluable for this measure.|Baseline, Cycle 1 Day 21|SUVmax was analyzed using imaging analysis set (participants in FAS who completed baseline [(18)F]-fluorodeoxyglucose PET [FDG-PET] and [(18)F]-FLT-PET, and at least 1 on-treatment [Day 21] PET) and phospho-Rb was analyzed using tumor analysis set (participants in FAS who completed tumor biomarker assessments at baseline and Day 21).||correlation coefficient|||Number
733409|NCT00420095|Secondary|Hypoglycemia Rate Per Participant Per 30 Days|Hypoglycemia rate per patient per 30 days = (number of reported hypogylcemia events/number of days within the period) * 30 days. Since this was a 2x2 cross-over design (2 treatments and 2 periods), then the hypogyclemia rate was calculated per patient for each of the 2 periods by treatment.|over 12 weeks of each treatment period|Includes all randomized patients who had at least one dose. Crossover study design allows for the comparison of the effect of two treatments on the same patients, each patient served as own control for between-treatment comparisons. The data from two periods were combined and analyzed.||events/30 days||95% Confidence Interval|Mean
733410|NCT00420095|Secondary|Number of Participants With Laboratory Parameters Significantly Different From Baseline|Number of participants with laboratory parameters (hematology, chemistry, and urinalysis) that were significantly different from baseline after 12 weeks of each treatment.|Baseline and 12 weeks of each treatment|Includes all randomized patients receiving at least one dose. Crossover study design allows for the comparison of the effect of two treatments on the same patients, each patient served as own control for between-treatment comparisons. The data from two periods were combined and analyzed.||participants|||Number
733411|NCT00420095|Secondary|Number of Participants Achieving Target Glycosylated Hemoglobin (HbA1c) Values <=7% and <=6.5%|Number of patients in each treatment group achieving the target HbA1c value during 12 weeks of each treatment.|12 weeks of each treatment|Includes all randomized patients who completed the study with no major protocol violations. Crossover study design allows for the comparison of the effect of two treatments on the same patients, each patient served as own control for between-treatment comparisons. The data from two periods were combined and analyzed.||participants|||Number
733412|NCT00420095|Secondary|Change in Total Daily Insulin Dose Values From Baseline to 12 Weeks of Treatment|Insulin lispro low mix was to be administered within 15 minutes of morning and evening meals. Human insulin mix 30/70 was to be administered within 30 minutes of morning and evening meals. Change = Baseline - Endpoint|Baseline and 12 weeks of each treatment|Includes all randomized patients who completed the study with no major protocol violations. Crossover study design allows for the comparison of the effect of two treatments on the same patients, each patient served as own control for between-treatment comparisons. The data from two periods were combined and analyzed. LOCF within each period.||units of insulin||95% Confidence Interval|Mean
733413|NCT00420095|Secondary|Change in Fasting Blood Glucose Values From Baseline to 12 Weeks of Treatment|Values obtained after at least an 8 hour fast. Change = Baseline - Endpoint|Baseline and 12 weeks of each treatment|Includes all randomized patients who completed the study with no major protocol violations. Crossover study design allows for the comparison of the effect of two treatments on the same patients, each patient served as own control for between-treatment comparisons. The data from two periods were combined and analyzed. LOCF within each period.||millimoles/Liter||95% Confidence Interval|Mean
733414|NCT00420095|Secondary|Changes in Glycosylated Hemoglobin (HbA1c) From Baseline to 12 Weeks of Treatment|Changes in glycosylated hemoglobin reflect the change in average blood glucose level between baseline and 12 weeks of treatment. Change = Baseline - Endpoint.|Baseline and at 12 weeks of each treatment|Includes all randomized patients who completed the study with no major protocol violations. Crossover study design allows for the comparison of the effect of two treatments on the same patients, each patient served as own control for between-treatment comparisons. The data from two periods were combined and analyzed.||percent of glycosylated hemoglobin||95% Confidence Interval|Mean
733415|NCT00420095|Primary|Glycosylated Hemoglobin (HbA1c) Value at 12 Week Endpoint|Glycosylated hemoglobin reflects the average blood glucose level over the previous 12 weeks of treatment.|Baseline and 12 weeks of each treatment|Includes all randomized patients who completed the study with no major protocol violations. Crossover study design allows for the comparison of the effect of two treatments on the same patients, each patient served as own control for between-treatment comparisons. The data from two periods were combined and analyzed.||percent of glycosylated hemoglobin||95% Confidence Interval|Mean
733416|NCT00420147|Primary|Knee Adduction Moment After 12 Months||12 months|||Nm/(kg-m)||Standard Deviation|Mean
733417|NCT00420147|Primary|Knee Adduction Moment at Baseline||Baseline|||Nm/(kg-m)||Standard Deviation|Mean
733419|NCT00420199|Secondary|Double-blind Period:Number of Participants With Significantly Abnormal Changes in Vital Signs|Vital signs, which included blood pressure, heart rate, respiration, and temperature, were monitored predose and 1 hour after start of infusion. Changes in vital signs were determined to be significantly abnormal at the discretion of the investigator but were generally those that either exceeded, or failed to reach, normal parameters. Normal vital sign parameter ranges varied by site.|Days 1, 15, 29, 57, 85, and 113|All randomized participants who received at least 1 dose of study medication.||participants|||Number
733420|NCT00420199|Primary|Double-blind Period: Mean Change From Baseline in OMERACT 6 Wrist Synovitis Score: Post Hoc Sensitivity Analysis Using Parametric ANCOVA Analysis|Wrist synovitis was assessed by postgadolinium MRI enhancement according to OMERACT 6 RAMRIS in 3 wrist regions: distal radioulnar, radiocarpal, and intercarpal and carpometacarpal joints. For each wrist region, possible score ranges from 0–3, with 0=normal, 1=mild, 2=moderate, and 3=severe damage. The total synovitis score per wrist=the sum of the individual scores for the 3 wrist regions. Minimum score per wrist ranges from 0, indicating no damage, to 9 (score of 3*3 wrist regions), indicating most severe damage. Change in synovitis score=Follow-up synovitis score-baseline synovitis score.|Baseline to Day 113|All randomized participants who received at least 1 dose of study medication and who had wrist synovitis assessments available at baseline and Day 113.||units on a scale||Standard Deviation|Mean
733421|NCT00420199|Secondary|Double-blind Period: Number of Participants With Laboratory Test Results in Other Chemistries and Urinalysis Meeting the Criteria for Marked Abnormality|LLN=lower limit of normal; ULN=upper limit of normal; BL-baseline. Marked abnormality c: serum glucose:<65 mg/dL/>220 mg/dL; fasting serum glucose: <0.8* LLN/>1.5* ULN, or if BL<LLN, use 0.8*BL or >ULN, or if BL>ULN, use >2.0*BL or <LLN; total protein: <0.9*LLN/>1.1* ULN; albumin: <0.9*LLN,or if BL<LLN, use <0.75 BL; uric acid: >1.5* ULN, or if BL>ULN, use >2*BL. Urinalysis (Urine protein, urine Glu, urine blood, leukocyte esterase, red blood cells, white blood cells):Use ≥2 when BL value missing or value ≥4,or when predose=0 or 0.5. Use ≥3 when predose=1. Use ≥4 when predose=2 or 3|From Day 1 to Day 113, and up to 56 days post last dose of double-blind period, or start of first dose of open-label period|All randomized participants who received at least 1 dose of study medication.||participants|||Number
733422|NCT00420199|Secondary|Double-blind Period: Number of Participants With Laboratory Test Results for Electrolytes Meeting the Criteria for Marked Abnormality|LLN=lower limit of normal; ULN=upper limit of normal; BL=baseline. Marked abnormality: Sodium: <0.95*LLN/>1.05*ULN,or if BL<LLN, use 0.95*BL or >ULN,or if BL>ULN, use>1.05*BL or <LLN. Potassium: <0.9*LLN/>1.1* ULN,or if BL<LLN, use 0.9*BL or >ULN, or if BL>ULN, use>1.1*BL or <LLN. Chloride: <0.9*LLN/>1.1*ULN, or if BL<LLN, use 0.9*BL or >ULN, or if BL>ULN, use>1.1*BL or <LLN. Calcium: <0.8*LLN/>1.2*ULN, or if BL<LLN, use 0.75*BL or >ULN, or if BL>ULN, use>1.25*BL or <LLN. Phosphorous: <0.75*LLN/>1.25*ULN, or if BL<LLN, use 0.67*BL or >ULN, or if BL>ULN, use>1.33*BL or <LLN.|From Day 1 to Day 113, and up to 56 days post last dose of double-blind period, or start of first dose of open-label period|All randomized participants who received at least 1 dose of study medication.||participants|||Number
733423|NCT00420199|Secondary|Double-blind Period: Number of Participants With Laboratory Test Results for Liver and Kidney Function Meeting Criteria for Marked Abnormality|ULN=upper limit of normal; BL=baseline. Marked abnormality criteria: Alkaline phosphatase: >2*ULN, or if BL>ULN, use >3*BL; aspartate aminotransferase: >3*ULN, or if BL>ULN,use >4*BL; alanine aminotransferase: >3*ULN, or if BL>ULN, use >4*BL; G-Glutamyl transferase: >2*ULN, or if BL>ULN, use >3*BL; Bilirubin: >2*ULN, or if BL>ULN, use >4*BL; blood urea nitrogen: >2*BL; creatinine: >1.5*BL.|From Day 1 to Day 113, and including up to 56 days post last dose of double-blind period, or start of first dose of open-label period|All randomized participants who received at least 1 dose of study medication.||participants|||Number
733424|NCT00420199|Secondary|Double-blind Period: Number of Participants With Laboratory Test Results in Hematology Meeting the Criteria for Marked Abnormality|BL=baseline; LLN=lower limit of normal; ULN=upper limit of normal. Marked abnormality criteria: Hemoglobin: >3 g/dL decrease from BL. Hematocrit: <0.75*BL. Erythrocytes: <0.75*BL. Platelets: <0.67*LLN/>1.5*ULN, or if BL <LLN, use 0.5*BL/<100,000 mm^3. Leukocytes: <0.75*LLN/>1.25*ULN, or if BL<LLN, use <0.8*BL/>ULN, or if BL>ULN, use >1.2*BL/<LLN. Neutrophils+bands: <1.0*10^3 c/uL. Eosinophils: >0.750*10^3 c/uL. Basophils: > 400 mm^3. Monocytes: >2000 mm^3. Lymphocytes: <0.750*10^3 c/uL/>7.50*10^3 c/uL.|From Day 1 to Day 113, and up to 56 days post last dose of double-blind period, or start of first dose of open-label period|All randomized participants who received at least 1 dose of study medication.||participants|||Number
733425|NCT00420199|Secondary|Double-blind Period: Number of Participants With Peri-infusional AEs of Special Interest|Peri-infusional AEs are AEs occurring during the first 24 hours after the start of study drug infusion. An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. AEs considered possibly, probably, or certainly related to study treatment were graded according to Common Terminology Criteria for Adverse Events, Version 3.0 (Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death).|From Day 1 to Day 113, and up to 56 days post last dose of double-blind period, or start of first dose of open-label period|All randomized participants who received at least 1 dose of study medication.||participants|||Number
733426|NCT00420199|Secondary|Double-blind Period: Number of Participants With Acute Infusional AEs of Special Interest|Acute infusional AEs are AEs with onset during the first hour after the start of study drug infusion. An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. AEs considered possibly, probably, or certainly related to study treatment were graded according to Common Terminology Criteria for Adverse Events ,Version 3.0 (Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death).|From Day 1 to Day 113, and up to 56 days post last dose of double-blind period, or start of first dose of open-label period|All randomized participants who received at least 1 dose of study medication.||participants|||Number
733436|NCT00420199|Secondary|Double-blind Period: Number of Participants With Newly Involved Joints in Bone Erosion, Edema/Osteitis, and Synovitis|Bone erosion and osteitis were assessed at a total of 23 anatomic locations according to erosion (for bone erosion) or involvement (for osteitis) of the original articular bone. Synovitis assessed as above-normal post-gadolinium enhancement in 3 wrist regions: distal radioulnar joint, radiocarpal joint, and intercarpal and carpometacarpal joints.|Baseline to Day 113|All randomized participants who received at least 1 dose of study medication and had erosion, edema, and synovitis assessments available at baseline and Day 113.||participants|||Number
733427|NCT00420199|Secondary|Double-blind Period: Number of Participants With Infections/Infestations of Special Interest|Infections/Infestations of Special Interest are AEs and SAEs considered possibly, probably, or certainly related to study treatment, graded according to Common Terminology Criteria for Adverse Events Version 3.0 (Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death). AE=any new untoward medical occurrence or worsening of a preexisting medical condition which does not necessarily have a causal relationship with this treatment.|From Day 1 to Day 113, and up to 56 days post last dose of double-blind period, or start of first dose of open-label period|All randomized participants who received at least 1 dose of study medication.||participants|||Number
733428|NCT00420199|Secondary|Double-blind Period: Number of Participants With AEs of Special Interest|An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including serious, opportunistic, and all other infections; autoimmune disorders; neoplasms; acute infusional AEs (prespecified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (prespecified AEs occurring within 24 hours of start of infusion).|From Day 1 to Day 113, and up to 56 days post last dose of double-blind period, or start of first dose of open-label period|All randomized participants who received at least 1 dose of study medication.||participants|||Number
733429|NCT00420199|Secondary|Double-blind Period: Number of Participants With Death, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Treatment-related AEs, and AEs Leading to Discontinuation|An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=possibly, probably, or certainly related to and of unknown relationship to study treatment.|From Day 1 to Day 113, and up to 56 days post last dose of double-blind period, or start of first dose of open-label period|All randomized participants who received at least 1 dose of study medication.||participants|||Number
733430|NCT00420199|Secondary|Double-blind Period: Median Percent Change From Baseline in Systemic Marker of Synovial Tissue Metabolism (Creatinine-corrected Urinary Glucosyl-Galactosyl-Pyridinoline [UGGPC])|Glucosyl-galactosyl-pyridinoline (Glc-Gal-PYD) is a specific biochemical marker reflecting the degradation of the synovial tissue membrane. It is a glycosylated derivative of the collagen crosslink pyridinoline, and it is present in significant amounts only in the synovial membrane; it is absent from bone and present in minutes amounts in cartilage and other soft tissues. Increased urinary levels of Glc-Gal-PYD have been found in early and long-standing rheumatoid arthritis, high levels being associated with rapid destruction.|Baseline to Days 15, 29, 57, 85, and 113|All randomized participants who received at least 1 dose of study medication.||percent change||Inter-Quartile Range|Median
733431|NCT00420199|Secondary|Double-blind Period: Median Percent Change From Baseline in a Systemic Marker of Cartilage Degradation (Creatinine-corrected Urinary Carboxyterminal Crosslinking Telopeptide of Type II Collagen [UCTX2C])|Urinary CTX-II is a biochemical marker of type II collagen breakdown. In participants with early rheumatoid arthritis, increased levels of CTX-II can be predictive of rapid radiographic progression over periods of 1 to 5 years. These markers of cartilage destruction can predict progression of joint damage, independent of clinical and biologic indices of disease activity and baseline joint damage.|Baseline to Days 15, 29, 57, 85, and 113|All randomized participants who received at least 1 dose of study medication.||percent change||Inter-Quartile Range|Median
733432|NCT00420199|Secondary|Double-blind Period: Median Percent Change From Baseline in Systemic Markers of Bone Destruction (Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen [CTX-I] and Serum Pyridinoline Cross-linked Telopeptide Domain of Type I Collagen [ICTP])|CTX-I and ICTP are biochemical markers of bone resorption or bone degradation|Baseline to Days 15, 29, 57, 85, and 113|All randomized participants who received at least 1 dose of study medication.||percent change||Inter-Quartile Range|Median
733433|NCT00420199|Secondary|Double-blind Period: Median Percent Change From Baseline in Systemic Markers of Bone Formation: Osteocalcin and Serum Intact N-terminal Propeptide of Type I Procollagen (PINP)|PINP and osteocalcin are markers of bone formation. Osteocalcin is synthesized by osteoblasts and is associated with osteoblast synthetic activity. Osteoblasts secrete type 1 procollagen, and cleavage of large fragments from the carboxy and amino terminal ends result in formation of mature type 1 collagen and production of PINP fragments.|Baseline to Days 15, 29, 57, 85, and 113|All randomized participants who received at least 1 dose of study medication.||percent change||Inter-Quartile Range|Median
733434|NCT00420199|Secondary|Double-blind Period: Adjusted Mean Change From Baseline in RAMRIS Scores|RAMRIS Score=sum of core components: Synovitis (S), Osteitis (O), and Erosion (E) Scores. S scored 0 (none) to 9 (maximum distension of synovial cavity); O scored 0 (none) to 69 (maximum articular bone involvement); E scored 0 (none) to 230 (maximum erosion of articular bone). RAMRIS=S+O+E Scores. RAMRIS minimum score=0 (normal), maximum=308 (severe structural damage). Adjusted change from baseline in RAMRIS=mean RAMRIS at Day 113-mean RAMRIS at baseline. Adjustment based on ANCOVA model: treatment=factor, baseline value=covariate.|Baseline to Day 113|All randomized participants who received at least 1 dose of study medication and had RAMRIS assessments available at baseline and Day 113.||units on a scale||Standard Deviation|Mean
733435|NCT00420199|Secondary|Double-blind Period: Baseline Mean RAMRIS Scores|RAMRIS score is the sum of its core components: Synovitis Score, Osteitis Score, and Erosion Score. Synovitis scored from 0 (normal) to 9 (maximum distension of synovial cavity). Osteitis scored 0 (normal) to 69 (maximum articular bone involvement). Erosion scored from 0 (normal) to 230 (maximum erosion of articular bone). RAMRIS=Synovial Score + Osteitis Score + Erosion Score. Minimum RAMRIS score=0 (normal), maximum RAMRIS score=308 (severe structural damage). For Synovial Score, Osteitis Score, Erosion Score, and RAMRIS score, increasing number=increasing severity.|Baseline|All randomized participants who received at least 1 dose of study medication and had RAMRIS assessments available at baseline.||units on a scale||Standard Deviation|Mean
733457|NCT00420238|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 14, 18, 24|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. A higher rate is consistent with inflammation.|Week 14, Week 18, Week 24|Open-label population; LOCF.||millimeters per hour||95% Confidence Interval|Mean
733437|NCT00420199|Secondary|Double-blind Period: Adjusted Mean Change From Baseline in Osteitis OMERACT 6 Scores|Osteitis assessed at 23 anatomic locations: 15 in 1 wrist and 8 in attached. Each site scored in 1.0 increments, indicating involvement of original articular bone (0=none to 3=severe). Total score for hands/wrists is sum of scores for each location. Maximum score per hand/wrist is 23 (total anatomic locations)*3 (maximum score per joint)=69. Minimum score=0(normal). Increasing score=greater severity. Adjusted mean change from baseline in osteitis score=mean score at Day 113-mean score at baseline. Adjustment based on ANCOVA model with treatment=factor and baseline value=covariate.|Baseline to Day 113|All randomized participants who received at least 1 dose of study medication and had osteitis OMERACT 6 assessments available at baseline and Day 113.||units on a scale||Standard Deviation|Mean
733438|NCT00420199|Secondary|Double-blind Period: Baseline Mean Osteitis OMERACT 6 Scores|Osteitis assessed at a total of 23 anatomic locations: 15 in 1 wrist and 8 in the hand of the same side. Each site is scored in 1.0 increments from 0 to 3, indicating involvement of original articular bone. The total score for the hands/wrists is the sum of the individual scores for each location. Thus the maximum score achievable per hand/wrist is 23 (total number of anatomic locations) * 3 (maximum per joint)=69. Minimum score=0, indicating normal. Increasing score=greater severity.|At baseline|All randomized participants who received at least 1 dose of study medication and had osteitis OMERACT 6 assessments available at baseline.||units on a scale||Standard Deviation|Mean
733439|NCT00420199|Primary|Double-blind Period: Mean Change From Baseline in OMERACT 6 Wrist Synovitis Score: Planned Analysis Using Non-Parametric ANCOVA|Wrist synovitis was assessed by postgadolinium MRI enhancement according to OMERACT 6 RAMRIS in 3 wrist regions: distal radioulnar, radiocarpal, and intercarpal and carpometacarpal joints. For each wrist region, possible score ranges from 0–3, with 0=normal, 1=mild, 2=moderate, and 3=severe damage. The total synovitis score per wrist=the sum of the individual scores for the 3 wrist regions. Minimum score per wrist ranges from 0, indicating no damage, to 9 (score of 3*3 wrist regions), indicating most severe damage. Change in synovitis=Follow-up synovitis score-baseline score.|Baseline to Day 113|All randomized participants who received at least 1 dose of study medication and had wrist synovitis assessments available at baseline and Day 113.||units on a scale||Standard Deviation|Mean
733440|NCT00420199|Secondary|Double-blind Period: Adjusted Mean Change From Baseline in Erosion OMERACT 6 Scores|Bone erosion assessed at 23 anatomic locations: 15 in 1 wrist and 8 in attached hand. Each site is scored in 1.0 increments from 0 (no damage) to 10 (severe damage), indicating erosion (each unit=10% bone loss) of original articular bone. Total erosion score for hands/wrists is sum of the individual scores for each location. Thus the maximum score per hand/wrist is 230. Increasing score=greater severity. Adjusted change from baseline in erosion score=mean score at Day 113-mean erosion score at baseline. Adjustment based on ANCOVA model with treatment=factor and baseline value=covariate.|Baseline to Day 113|All randomized participants who received at least 1 dose of study medication and had erosion OMERACT 6 assessments available at baseline and Day 113.||units on a scale||Standard Deviation|Mean
733441|NCT00420199|Secondary|Double-blind Period: Baseline Mean Erosion OMERACT 6 Scores|Bone erosion assessed at a total of 23 anatomic locations: 15 in 1 wrist and 8 in the hand of the same side. Each site is scored in 1.0 increments from 0 (no damage) to 10 (severe damage) according to erosion of the original articular bone (each unit=10% loss of articular bone). The total erosion score for the hands/wrists is the sum of the individual scores for each location. Thus the maximum score achievable per hand/wrist is 230. Increasing score=greater severity.|At baseline|All randomized participants who received at least 1 dose of study medication and had erosion OMERACT 6 assessments available at baseline.||units on a scale||Standard Deviation|Mean
733442|NCT00420199|Primary|Double-blind Period: Mean Synovitis Scores at Baseline As Measured by the Rheumatoid Arthritis Clinical Trials 6 (OMERACT 6) Rheumatoid Arthritis Magnetic Resonance Imaging Score (RAMRIS)|Wrist synovitis was assessed by postgadolinium MRI enhancement according to OMERACT 6 RAMRIS in 3 wrist regions: distal radioulnar, radiocarpal, and intercarpal and carpometacarpal joints. For each wrist region, possible score ranges from 0–3, with 0=normal, 1=mild, 2=moderate, and 3=severe damage. The total synovitis score per wrist=the sum of the individual scores for the 3 wrist regions. Minimum score per wrist ranges from 0, indicating no damage, to 9 (score of 3*3 wrist regions), indicating most severe damage. Change in synovitis = Follow-up synovitis score - baseline score.|At baseline|All randomized participants who received at least 1 dose of study medication and had synovitis assessments available at baseline.||units on a scale||Standard Deviation|Mean
733443|NCT00420212|Secondary|Proportion of Subjects Experiencing Progression of Disability Assessed Using the Expanded Disability Status Scale (EDSS)|The EDSS is based on a standardized neurological examination and focuses on symptoms that commonly occur in MS. EDSS scores range from 0.0 (normal) to 10.0 (death due to MS). Disability progression was defined as ≥ 1.0 point increase in subjects with a baseline EDSS of ≥1.0, or a ≥1.5 point increase in subjects with a baseline EDSS = 0, and required that the increase from baseline was confirmed ≥12 weeks later. The proportion of subjects with confirmed (12-week) disability progression was estimated using the Kaplan-Meier method, which was based on the time-to-first-progression survival distribution.|2 years|The analysis population consisted of the ITT population (all subjects who were randomized and received at least 1 dose of study medication) who had a baseline EDSS assessment. Analysis were based on all observed data. Onset of disability progression must begin before a subject switched to alternative MS medication.||Proportion of participants|||Number
733444|NCT00420212|Secondary|Annualized Relapse Rate|A protocol-defined relapse was defined as new or recurrent neurologic symptoms not associated with fever or infection that lasted at least 24 hours, and were separated by at least 30 days from onset of a preceding relapse. All protocol-defined relapses were evaluated by an independent neurologic evaluation committee. The adjusted annualized relapse rate was calculated from a negative binomial regression model, adjusted for baseline EDSS (≤ 2.0 vs. >2.0), age (<40 versus ≥40 years), region, and the number of relapses in the 1 year prior to enrollment.|2 years|The ITT population was defined as all subjects who were randomized and received at least 1 dose of study medication. Among subjects who switched to an alternative therapy for multiple sclerosis, all the data before the switch were used for the analysis. In all other subjects, all relapses were included in the analysis.||Relapses per year||95% Confidence Interval|Mean
733493|NCT00420238|Secondary|Change From Baseline in Total Back Pain at Weeks 2, 4, 8, 12|Subject assessment of total back pain due to ankylosing spondylitis during the last 48 hours using a 100 millimeter (mm) Visual Analog Scale (VAS); range: 0=none to 100=extreme.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF.||units on scale||95% Confidence Interval|Least Squares Mean
733445|NCT00420212|Secondary|Number of Subjects With Gadolinium (Gd)-Enhancing Lesions|"Note: This outcome measure represents the categorical analysis for the previously listed secondary outcome measure Number of Gadolinium-enhancing T1-weighted lesions"|2 years|Of the 540 subjects included in the MRI cohort, 469 (165 placebo,152 BG00012 BID,152 BG00012 TID) had post-baseline Gd-enhancing lesion data & were included in the analysis. Missing data before the use of alternative MS medications & visits after patients switched to alternative MS medications were imputed with the use of a constant rate assumption||Number of subjects|||Number
733446|NCT00420212|Secondary|Number of Gadolinium-enhancing T1-weighted Lesions|The number of Gd-enhancing lesions was assessed using brain MRI scans following administration of gadolinium, a contrast agent. The mean number of Gd-enhancing lesions at 2 years was the average of the number of lesions at 2 years in a treatment group.|2 years|Of the 540 subjects included in the MRI cohort, 469 (165 placebo,152 BG00012 BID,152 BG00012 TID) had post-baseline Gd-enhancing lesion data & were included in the analysis. Missing data before the use of alternative MS medications & visits after patients switched to alternative MS medications were imputed with the use of a constant rate assumption||Number of lesions||Standard Deviation|Mean
733447|NCT00420212|Secondary|Number of New or Newly Enlarging T2 Hyperintense Lesions|The number of new or newly enlarging T2 hyperintense lesions at 2 years that developed in each subject compared to baseline assessed on brain magnetic resonance imaging (MRI) scans. The estimates of mean T2 lesion count were calculated from a negative binomial regression model adjusted for region and baselineT2 lesion volume|2 years|Of the 540 subjects included in the MRI cohort, 469 subjects (165 placebo, 152 BG00012 BID, 152 BG00012 TID) had post-baseline T2 data and were included in the analysis. Missing data before the use of alternative MS medications and visits after patients switched to alternative MS medications were imputed with the use of a constant rate assumption.||Number of lesions||95% Confidence Interval|Mean
733448|NCT00420212|Primary|Proportion of Subjects Relapsed|A protocol-defined relapse was defined as new or recurrent neurologic symptoms not associated with fever or infection that lasted at least 24 hours, and were separated by at least 30 days from onset of a preceding relapse. All protocol-defined relapses were evaluated by an independent neurolgic evaluation committee. The proportion of subjects with a relapse was estimated using the Kaplan-Meier method, which was based on the time-to-first-relapse survival distribution.|2 years|The analysis was based on the ITT population, defined as all subjects who were randomized and received at least 1 dose of study medication. Among subjects who switched to an alternative therapy for multiple sclerosis, all the data before the switch were used for the analysis. In all other subjects, all relapses were included in the analysis.||Proportion of subjects,confirmed relapse|||Number
733449|NCT00420238|Secondary|Percent of Subjects With Minimum Clinially Important Improvement (MCII) at Weeks 14, 18, 24|Subjects were asked how their pain had been during the last 48 hours compared to baseline. Those subjects that reported improvement assessed how important this improvement was to them; range: very important, moderately important, slightly important, or not at all important. Binary response options: 1=improved very important, or improved moderately important; 2=slightly important, not at all important, no change, or worse-more pain.|Week 14, Week 18, Week 24|Open-label population; in the case of missing data, no replacement or imputation method was performed. Abbreviation: Mod = moderately.||percent of participants|||Number
733450|NCT00420238|Secondary|Percent of Subjects With Minimum Clinically Important Improvement (MCII) in Pain Rating at Weeks 2, 4, 8, 12|Subjects were asked how their pain had been during the last 48 hours compared to baseline. Those subjects that reported improvement assessed how important this improvement was to them; range: very important, moderately important, slightly important, or not at all important. Binary response options: 1=improved very important, or improved moderately important; 2=slightly important, not at all important, no change, or worse-more pain.|Week 2, Week 4, Week 8, Week 12|mITT; in the case of missing data, no replacement or imputation method was performed. Abbreviation: Mod = moderately.||percent of participants|||Number
733451|NCT00420238|Secondary|Percent of Subjects With Patient Acceptable and Unacceptable Symptom State (PASS) at Weeks 14, 18, 24|"Percent of subjects reporting acceptable symptom state: acceptance to remain for the rest of their lives with the level of pain they had during the last 48 hours; and unacceptable symptom state: not able to remain for the rest of their lives with the level of pain they had during the last 48 hours. In the case of missing data, subjects who withdrew from the study because of inefficacy or toxicity were considered unacceptable."|Week 14, Week 18, Week 24|Open-label population. In the case of missing data, no replacement or imputation method was performed.||percent of participants|||Number
733452|NCT00420238|Secondary|Percent of Subjects With Patient Acceptable and Unacceptable Symptom State (PASS) at Weeks 2, 4, 8, 12|"Percent of subjects reporting acceptable symptom state: acceptance to remain for the rest of their lives with the level of pain they had during the last 48 hours; and unacceptable symptom state: not able to remain for the rest of their lives with the level of pain they had during the last 48 hours. In the case of missing data, subjects who withdrew from the study because of inefficacy or toxicity were considered unacceptable."|Week 2, Week 4, Week 8, Week 12|mITT. In the case of missing data, no replacement or imputation method was performed.||percent of participants|||Number
733453|NCT00420238|Secondary|Percent of Subjects With Normal and Abnormal C-Reactive Protein at Weeks 14, 18, 24|Percent of participants with normal (<6 milligrams per liter) and abnormal (>= 6 milligrams per liter) C-Reactive Protein.|Week 14, Week 18, Week 24|Open-label population; LOCF.||percent of participants|||Number
733454|NCT00420238|Secondary|Change From Baseline in C-reactive Protein (CRP) at Weeks 14, 18, 24|Change from baseline in C-reactive Protein (CRP).|Week 14, Week 18, Week 24|Open-label population; LOCF.||milligrams per liter||95% Confidence Interval|Mean
733455|NCT00420238|Secondary|Change From Baseline in C-reactive Protein (CRP) at Weeks 2, 4, 8, 12|CRP is a marker of inflammation. A higher level is consistent with inflammation.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT. LOCF.||milligrams per liter||95% Confidence Interval|Least Squares Mean
733456|NCT00420238|Secondary|Normalized Net Incremental Area Under the Curve (AUC) for C-reactive Protein Between Baseline and Week 12|Normalized net incremental area under the curve (AUC) = area between baseline and the C-reactive Protein curve as a function of time (randomization to Week 12); computed using the linear trapezoidal method. All areas above baseline and under the curve are positive and all areas below baseline and above the curve are negative. Net incremental AUC = sum of these areas; this result was then divided by the study duration of the patients; negative value = improvement.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF.||milligrams per liter||95% Confidence Interval|Least Squares Mean
733458|NCT00420238|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. A higher rate is consistent with inflammation.|Week 2, Week 4, Week 8, Week 12|mITT; LOCF. N = number of subjects with evaluable data.||millimeters per hour||95% Confidence Interval|Least Squares Mean
733459|NCT00420238|Secondary|Normalized Net Incremental Area Under the Curve (AUC) for Erythtocyte Sedimentation Rate Between Baseline and Week 12|Normalized net incremental area under the curve (AUC) = area between baseline and the Erythrocyte Sedimentation Rate curve as a function of time (randomization to Week 12); computed using the linear trapezoidal method. All areas above baseline and under the curve are positive and all areas below baseline and above the curve are negative. Net incremental AUC = sum of these areas; this result was then divided by the study duration of the patients; negative value = improvement.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF. N=number of subjects with evaluable data.||millimeters per hour||95% Confidence Interval|Least Squares Mean
733460|NCT00420238|Secondary|Change From Baseline in Self Assessment of Ability and or Easiness to Perform Physically Demanding Activities at Weeks 14, 18, 24|Subject evaluation of level of difficulty to perform daily physical activities and/or kinesitherapy for ankylosing spondylitis (AS) due to AS using a 100 millimeter Visual Analog Scale (VAS) ranging from 0=easy to 100=impossible. Subgroup of subjects who responded that they were able to perform daily physical activities and/or kinesitherapy for their ankylosing spondylitis at each visit.|Week 14, Week 18, Week 24|Open-label population; LOCF.||units on scale||95% Confidence Interval|Mean
733461|NCT00420238|Secondary|Change From Baseline in Level of Difficulty to Perform Physically Demanding Activities Due to Ankylosing Spondylitis at Weeks 2, 4, 8, 12|Subject evaluation of level of difficulty to perform daily physical activities and/or kinesitherapy for ankylosing spondylitis (AS) because of AS using a 100 millimeter Visual Analog Scale (VAS) ranging from 0=easy to 100=impossible. Subgroup of subjects who responded that they were able to perform daily physical activities and/or kinesitherapy for their ankylosing spondylitis at each visit.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF. N = subgroup of subjects who reported performing daily physical activities and/or kinesitherapy for their ankylosing spondylitis at each visit (Week 2 through Week 12).||units on scale||95% Confidence Interval|Least Squares Mean
733462|NCT00420238|Secondary|Change From Baseline in the Chest Expansion Test at Weeks 14, 18, 24|Measurement and remeasurement of standing maximal inspiration; chest circumference at nipple line or at 4th intercostal space in centimeters (cm).|Week 14, Week 18, Week 24|Open-label population; LOCF.||centimeters||95% Confidence Interval|Mean
733463|NCT00420238|Secondary|Change From Baseline in the Chest Expansion Test at Weeks 2, 4, 8, 12|Measurement and remeasurement of standing maximal inspiration; chest circumference at nipple line or at 4th intercostal space in centimeters.|Week 2, Week 4, Week 8, Week 12|mITT; LOCF. N=number of subjects with evaluable data.||centimeters||95% Confidence Interval|Least Squares Mean
733464|NCT00420238|Secondary|Normalized Net Incremental Area Under the Curve (AUC) for the Chest Expansion Test Between Baseline and Week 12|Normalized net incremental area under the curve (AUC) = area between baseline and the Chest Expansion Test curve as a function of time (randomization to Week 12); computed using the linear trapezoidal method. All areas above baseline and under the curve are positive and all areas below baseline and above the curve are negative. Net incremental AUC = sum of these areas; this result was then divided by the study duration of the patients; negative value = improvement.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF. N=number of subjects with evaluable data.||centimeters||95% Confidence Interval|Least Squares Mean
733465|NCT00420238|Secondary|Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Intermalleolar Distance at Weeks 14, 18, 24|Measurement in centimeters (cm) of the distance between the medial malleoli when subject is lying supine with knees and feet straight up with legs separated as far as possible. Measurement of two attempts. Mean of ordinal scores from 0: >= 120 cm, to 9: 30 to 39.9 cm.|Week 14, Week 18, Week 24|Open-label population; in the case of missing data, no replacement or imputation method was performed.||centimeters||95% Confidence Interval|Mean
733466|NCT00420238|Secondary|Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Intermalleolar Distance at Baseline and Weeks 2, 4, 8, 12|Measurement in centimeters (cm) of the distance between the medial malleoli when subject is lying supine with knees and feet straight up with legs separated as far as possible. Measurement of two attempts. Mean of ordinal scores from 0: >= 120 cm, to 9: 30 to 39.9 cm.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT. In the case of missing data, no replacement or imputation method was performed.||centimeters||95% Confidence Interval|Mean
733467|NCT00420238|Secondary|Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Modified Schober's Test at Weeks 14, 18, 24|Measurement in centimeters of the distance between marks originally placed while the subject was standing erect 10 centimeters (cm) above and 5 cm below the midpoint of a line that joints the posterior superior iliac spines. Distance between marks was remeasured with subject maximally bend forward, knees fully extended, with spine in full flexion. Measurement of two attempts. Mean of ordinal scores from 1: 5.7 to 6.3 cm, to 10: <=0.7 cm.|Week 14, Week 18, Week 24|Open-label population; in the case of missing data, no replacement or imputation method was performed.||centimeters||95% Confidence Interval|Mean
733468|NCT00420238|Secondary|Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Modified Schober's Test at Baseline and Weeks 2, 4, 8, 12|Measurement in centimeters of the distance between marks originally placed while the subject was standing erect 10 centimeters (cm) above and 5 cm below the midpoint of a line that joints the posterior superior iliac spines. Distance between marks was remeasured with subject maximally bend forward, knees fully extended, with spine in full flexion. Measurement of two attempts. Mean of ordinal scores from 1: 5.7 to 6.3 cm, to 10: <=0.7 cm.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT. In the case of missing data, no replacement or imputation method was performed.||centimeters||95% Confidence Interval|Mean
733469|NCT00420238|Secondary|Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Lateral Flexion at Weeks 14, 18, 24|Measurement in centimters (cm) of distance between subject's middle fingertip and the floor after bending sideways, without bending knees or lifting heels, while attempting to keep shoulders in same place (flexion position). Measurement of two attempts on each side (right and left). Mean of ordinal scores from 0: >=20 cm to 10: <=1.2 cm.|Week 14, Week 18, Week 24|Open-label population; in the case of missing data, no replacement or imputation method was performed.||centimeters||95% Confidence Interval|Mean
733470|NCT00420238|Secondary|Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Lateral Flexion at Baseline and Weeks 2, 4, 8, and 12|Measurement in centimters (cm) of distance between subject's middle fingertip and the floor after bending sideways, without bending knees or lifting heels, while attemting to keep shoulders in same place (flexion position). Measurement of two attempts on each side (right and left). Mean of ordinal scores from 0: >=20 cm to 10: <=1.2 cm.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT. In the case of missing data, no replacement or imputation method was performed.||centimeters||95% Confidence Interval|Mean
733471|NCT00420238|Secondary|Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Tragus-to-wall Measurement at Weeks 14, 18, 24|Measurement in centimeters (cm) of distance between the tragus and wall from right and left side while subject is standing with back against the wall; knees straight; scapulae, buttocks, and heels against the wall; with head in neutral position. Measurement of two tries on right and left sides. Mean of ordinal scores from 0: <= 10 cm to 10: >= 37 cm.|Week 14, Week 18, Week 24|Open-label population; in the case of missing data, no replacement or imputation method was performed.||centimeters||95% Confidence Interval|Mean
733472|NCT00420238|Secondary|Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Tragus-to-wall Distance at Baseline and Weeks 2, 4, 8, 12|Measurement in centimeters (cm) of distance between the tragus and wall from right and left side while subject is standing with back against the wall; knees straight; scapulae, buttocks, and heels against the wall; with head in neutral position. Measurement of two attempts on right and left sides. Mean of ordinal scores from 0: <= 10 cm to 10: >= 37 cm.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT. In the case of missing data, no replacement or imputation method was performed.||centimeters||95% Confidence Interval|Mean
733473|NCT00420238|Secondary|Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Cervical Rotation at Weeks 14, 18, 24|Cervical rotation: measurement in degree to which the subjects could turn their heads as far as possible to the right and then to the left. Mean of ordinal scores from 0: >= 85 degrees to 10: <= 8.5 degrees.|Week 14, Week 18, Week 24|Open-label population; in the case of missing data, no replacement or imputation method was performed.||units on scale||95% Confidence Interval|Mean
733474|NCT00420238|Secondary|Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Cervical Rotation at Weeks 2, 4, 8, 12|Cervical rotation: measurement of degrees to which the subjects could turn their heads as far as possible to the right and then to the left. Mean of ordinal scores from 0: >= 85 degrees to 10: <= 8.5 degrees.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF. In the case of missing data, no replacement or imputation method was performed.||units on scale||95% Confidence Interval|Mean
733475|NCT00420238|Secondary|Change From Baseline in Spinal Mobility Measured With the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Weeks 14, 18, 24|BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober’s test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10. Higher score = greater reduction in spinal mobility.|Week 14, Week 18, Week 24|Open-label population; LOCF.||units on scale||95% Confidence Interval|Mean
733476|NCT00420238|Secondary|Change From Baseline in Spinal Mobility Measured With the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Weeks 2, 4, 8, 12|BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10. Higher score = greater reduction in spinal mobility.|Week 2, Week 4, Week 8, Week 12|mITT; LOCF.||units on scale||95% Confidence Interval|Least Squares Mean
733477|NCT00420238|Secondary|Normalized Net Incremental Area Under the Curve (AUC) for the Bath Ankylosing Spondylitis Metrology Index (BASMI) Between Baseline and Week 12|BASMI was composed of 5 measures; each measure scored 0-2 (0=normal mobility, 2=severe reduction); final score range: 0 to 10. Normalized net incremental area under the curve (AUC) = area between baseline and the BASMI curve as a function of time (randomization to Week 12); computed using the linear trapezoidal method. All areas above baseline and under the curve are positive and all area below baseline and above the curve are negative. Net incremental AUC = sum of these areas; this result was then divided by the study duration of the patients; negative value = improvement.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF.||millimeters||95% Confidence Interval|Least Squares Mean
733478|NCT00420238|Secondary|Change From Baseline to Week 12 in Ratio Forced Expitatory Volume in One Second (FEV1)/Forced Vital Capacity (FVC) (%)||Baseline, Week 12|mITT; N=number of subjects with evaluable data. In the case of missing data, no replacement or imputation method was performed.||percent||95% Confidence Interval|Least Squares Mean
733479|NCT00420238|Secondary|Change From Baseline to Week 12 in Forced Vital Capacity (FVC), Vital Capacity (VC), and Forced Expiratory Volume in One Second (FEV1)||Baseline, Week 12|mITT. In the case of missing data, no replacement or imputation method was performed.||liters||95% Confidence Interval|Least Squares Mean
733480|NCT00420238|Secondary|Bath Ankylosing Spondylitis Global Score (BAS-G) Independent Component: Effect of Disease on Well-being at Weeks 2, 4, 8, 12|Subject evaluation of the effect of their disease on well-being over the last week using a using a 100 millimeter Visual Anaog Scale; range: 0=none to 100=very important.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF.||units on scale||95% Confidence Interval|Mean
733481|NCT00420238|Secondary|Change From Baseline in the Bath Ankylosing Spondylitis-Global Score (BAS-G) at Weeks 14, 18, 24|Subject assessment of the effect of their disease on well-being over last 48 hours using a 100 millimeter Visual Analog Scale (VAS); range: 0=none to 100=very important.|Week 14, Week 18, Week 24|Open-label population; LOCF.||units on scale||95% Confidence Interval|Mean
733482|NCT00420238|Secondary|Change From Baseline in the Bath Ankylosing Spondylitis-Global Score (BAS-G) at Weeks 2, 4, 8, 12|Subject assessment of the effect of their disease on well-being over last 48 hours using a 100 millimeter (mm) Visual Analog Scale (VAS); range: 0=none to 100=very important.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF. N=number of subjects with evaluable data.||units on scale||95% Confidence Interval|Least Squares Mean
733483|NCT00420238|Secondary|Normalized Net Incremental Area Under the Curve (AUC) for Bath Ankylosing Spondylitis-Global Score (BAS-G) Visual Analog Scale Between Baseline and Week 12|BAS-G was measured using a 100 millimeter Visual Analog Scale (VAS) ranging from 0=none to 100=very important. Normalized net incremental area under the curve (AUC) = area between baseline and the BAS-G curve as a function of time (randomization to Week 12); computed using the linear trapezoidal method. All areas above baseline and under the curve are positive and all area below baseline and above the curve are negative. Net incremental AUC = sum of these areas; this result was then divided by the study duration of the patients; negative value = improvement.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF. N=number of subjects with evaluable data.||millimeters||95% Confidence Interval|Least Squares Mean
733484|NCT00420238|Secondary|Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 14, 18, 24|BASDAI subject rated components over last 48 hours using a 100 millimeter Visual Analog Scale; components 1-5: range 0=none to 100=very severe; component 6: range:0=0 hours to 100=2 hours or more. 1) Overall level of fatigue/tiredness experienced; 2) Overall level of AS neck,back or hip pain experienced; 3)Overall level of pain/swelling in joints other than neck,back or hips; 4) Overall level of discomfort from any areas tender to touch or pressure; 5) Overall level of morning stiffness from time of awakening; 6) Duration of morning stiffness from time of awakening.|Week 14, Week 18, Week 24|Open-label population; in case of missing data, no replacement or imputation method was performed. Abbreviations: C=component, AS=Ankylosing Spondylitis.||units on scale||95% Confidence Interval|Mean
733485|NCT00420238|Secondary|Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12|BASDAI subject rated components over last 48 hours using 100 mm Visual Analog Scale; components 1-5: range 0=none to 100=very severe; component 6: range:0=0 hours to 100=2 hours or more. 1) Overall level of fatigue/tiredness experienced; 2) Overall level of AS neck,back or hip pain experienced; 3) Overall level of pain/swelling in joints other than neck, back or hips; 4) Overall level of discomfort from any areas tender to touch or pressure; 5) Overall level of morning stiffness from time of awakening; 6) Duration of morning stiffness from time of awakening, and morning stiffness subscale.|Week 2, Week 4, Week 8, Week 12|mITT; in case of mising data, no replacement or imputation method was performed. Abbreviations: C=component, AS=Ankylosing Spondylitis.||units on scale||95% Confidence Interval|Mean
733486|NCT00420238|Secondary|Change From Baseline in the Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) at Weeks 14, 18, 24|BASDAI is a validated self assessment tool used to determine disease activity in patients with ankylosing spondylitis (AS) in the last 48 hours. Utilizing a Visual Analog Scale (VAS) of 0–10 (0=none and 10=very severe) patient’s answered 6 questions measuring discomfort, pain and fatigue. The BASDAI final mean score was calculated taking all 6 VAS assessments.|Week 14, Week 18, Week 24|Open-label population; LOCF.||units on scale||95% Confidence Interval|Mean
733487|NCT00420238|Secondary|Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Weeks 2, 4, 8, 12|BASDAI is a validated self assessment tool used to determine disease activity in patients with ankylosing spondylitis in the last 48 hours. Utilizing a Visual Analog Scale (VAS) of 0–10 (0=none and 10=very severe) patient’s answered 6 questions measuring discomfort, pain and fatigue. The BASDAI final mean score was calculated taking all 6 VAS assessments.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF.||units on a scale||95% Confidence Interval|Least Squares Mean
733488|NCT00420238|Secondary|Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24|Subject rating of last 48 hours, 100 mm Visual Analog Scale; range 0=easy to 100=impossible: 1) Putting on socks/tights without (w/o) help; 2) Bending forward from waist to pickup pen from floor w/o aid; 3) Reaching to high shelf w/o aid; 4) Getting out of armless dining room chair w/o using hands/other help; 5) Getting up off floor w/o help from lying on back; 6) Standing unsupported 10 minutes w/o discomfort; 7) Climbing 12-15 steps w/o handrail or walking aid; 8) Looking over shoulder w/o turning body; 9) Doing physically demanding activities; 10) Doing full days activities (home or work).|Week 14, Week 18, Week 24|Open-label population; in the case of missing data, no replacement or imputation method was performed. Abbreviations: C=component (number), Act=Activities.||units on a scale||95% Confidence Interval|Mean
733489|NCT00420238|Secondary|Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12|Subject rating of last 48 hours, 100 millimeter Visual Analog Scale; range 0=easy to 100=impossible: 1)Putting on socks/tights without (w/o) help; 2)Bending forward from waist to pickup pen from floor w/o aid; 3)Reaching to high shelf w/o aid; 4)Getting out of armless dining room chair w/o using hands/other help; 5)Getting up off floor w/o help from lying on back; 6)Standing unsupported 10 minutes w/o discomfort; 7)Climbing 12-15 steps w/o handrail or walking aid; 8)Looking over shoulder w/o turning body; 9) Doing physically demanding activities; 10) Doing full days activities (home or work).|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; in the case of missing data, no replacement or imputation method was performed. Abbreviations: C = component (number), Act = Activities.||units on a scale||95% Confidence Interval|Mean
733490|NCT00420238|Secondary|Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, 8, 12|BASFI is a validated self assessment tool that determines the degree of functional limitation in ankylosing spondylitis (AS) patients using a 100 millimeter (mm) Visual Analog Scale (VAS) measuring level of ability with activities in the last 48 hours; range: 0=easy to 100=impossible. Higher score = greater limitation.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF. N = number of subjects with evaluable data.||units on scale||95% Confidence Interval|Least Squares Mean
733491|NCT00420238|Secondary|Normalized Net Incremental Area Under the Curve (AUC) for the Bath Ankylosing Spondylitis Functional Index (BASFI) Between Baseline and Week 12|BASFI was measured using a 100 millimeter Visual Analog Scale (VAS) ranging from 0 = easy to 100 = impossible. Normalized net incremental area under the curve (AUC) = area between baseline and the BASFI curve as a function of time (randomization to Week 12); computed using the linear trapezoidal method. All areas above baseline and under the curve are positive and all area below baseline and above the curve are negative. Net incremental AUC = sum of these areas; this result was then divided by the study duration of the patients; negative value = improvement.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF. N=number of subjects with evaluable data.||millimeters||95% Confidence Interval|Least Squares Mean
733492|NCT00420238|Secondary|Change From Baseline in Total Back Pain at Weeks 14, 18, 24|Subject assessment of total back pain due to ankylosing spondylitis during the last 48 hours using a 100 millimeter Visual Analog Scale (VAS); range: 0=none to 100=extreme.|Week 14, Week 18, Week 24|Open-label population; LOCF.||units on scale||95% Confidence Interval|Mean
733494|NCT00420238|Secondary|Normalized Net Incremental Area Under the Curve (AUC) for Total Back Pain Between Baseline and Week 12|Total back pain was measured using a 100 millimeter Visual Analog Scale (VAS); range: 0 = none to 100 = extreme. Normalized net incremental area under the curve (AUC) = area between baseline and the Total Back Pain curve as a function of time (randomization to Week 12); computed using the linear trapezoidal method. All areas above baseline and under the curve are positive and all area below baseline and above the curve are negative. Net incremental AUC = sum of these areas; this result was then divided by the study duration of the patients; negative value = improvement.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF. N=number of subjects with evaluable data.||millimeters||95% Confidence Interval|Least Squares Mean
733495|NCT00420238|Secondary|Change From Baseline in Nocturnal Back Pain at Weeks 14, 18, 24|Subject assessment of nocturnal back pain due to ankylosing spondylitis during the last 48 hours using a 100 millimeter (mm) Visual Analog Scale (VAS); range: 0=none to 100=extreme.|Week 14, Week 18, Week 24|Open-label population; LOCF.||units on scale||95% Confidence Interval|Mean
733496|NCT00420238|Secondary|Change From Baseline in Nocturnal Back Pain at Weeks 2, 4, 8, 12|Subject assessment of nocturnal back pain due to ankylosing spondylitis during the last 48 hours using a 100 millimeter (mm) Visual Analog Scale (VAS); range: 0=none to 100=extreme.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF.||units on scale||95% Confidence Interval|Least Squares Mean
733497|NCT00420238|Secondary|Normalized Net Incremental Area Under the Curve (AUC) for Nocturnal Back Pain Between Baseline and Week 12|Nocturnal back pain was measured using a 100 millimeter Visual Analog Scale (VAS); range: 0 = none to 100 = extreme. Normalized net incremental area under the curve (AUC) = area between baseline and the Nocturnal Back Pain curve as a function of time (randomization to Week 12); computed using the linear trapezoidal method. All areas above baseline and under the curve are positive and all area below baseline and above the curve are negative. Net incremental AUC = sum of these areas; this result was then divided by the study duration of the patients; negative value = improvement.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF. N=number of subjects with evaluable data.||millimeters||95% Confidence Interval|Least Squares Mean
733498|NCT00420238|Secondary|Change From Baseline in Physician Global Assessment at Weeks 14, 18, 24|Physician global assessment of all the ways ankylosing spondylitis has affected patient during the last 48 hours. 100 millimeter (mm) Visual Analog Scale (VAS); range: 0=very good to 100=very bad.|Week 14, Week 18, Week 24|Open-label population; LOCF.||units on scale||95% Confidence Interval|Mean
733499|NCT00420238|Secondary|Change From Baseline in Physician Global Assessment Visual Analog Scale at Weeks 2, 4, 8, 12|Physician global assessment of all the ways ankylosing spondylitis has affected patient during the last 48 hours. 100 millimeter (mm) Visual Analog Scale (VAS); range: 0=very good to 100=very bad.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF. N = number of subjects with evaluable data.||units on scale||95% Confidence Interval|Least Squares Mean
733500|NCT00420238|Secondary|Normalized Net Incremental Area Under the Curve (AUC) for Physician Global Assessment (PGA) Between Baseline and Week 12|PGA was measured using a 100 millimeter Visual Analog Scale (VAS) ranging from 0 = very good to 100 = very bad. Normalized net incremental area under the curve (AUC) = area between baseline and the Physician Global Assessment curve as a function of time (randomization to Week 12); computed using the linear trapezoidal method. All areas above baseline and under the curve are positive and all area below baseline and above the curve are negative. Net incremental AUC = sum of these areas; this result was then divided by the study duration of the patients; negative value = improvement.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF. N= number of subjects with evaluable data.||millimeters||95% Confidence Interval|Least Squares Mean
733501|NCT00420238|Secondary|Change From Baseline in Patient Global Assessment at Weeks 14, 18, 24|Patient global assessment of all the ways ankylosing spondylitis affected them in the last 48 hours using a 100 millimeter (mm) Visual Analog Scale (VAS); range 0=very good to 100=very bad.|Week 14, Week 18, Week 24|Open-label population; LOCF.||units on scale||95% Confidence Interval|Mean
733502|NCT00420238|Secondary|Change From Baseline in Patient Global Assessment Visual Analog Scale (VAS) at Weeks 2, 4, 8, 12|Patient global assessment of all the ways ankylosing spondylitis affected them in the last 48 hours using a 100 millimeter (mm) Visual Analog Scale (VAS); range 0=very good to 100=very bad.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF.||units on scale||95% Confidence Interval|Least Squares Mean
733503|NCT00420238|Secondary|Normalized Net Incremental Area Under the Curve (AUC) for Patient Global Assessment (PGA) Between Baseline and Week 12|PGA was measured using a 100 millimeter Visual Analog Scale (VAS) ranging from 0 = very good to 100 = very bad. Normalized net incremental area under the curve (AUC)=area between baseline and the Patient Global Asessment curve as a function of time (randomization to Week 12); computed using the linear trapezoidal method. All areas above baseline and under the curve are positive and all area below baseline and above the curve are negative. Net incremental AUC = sum of these areas; this result was then divided by the study duration of the patients; negative value = improvement.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF. N = number of subjects with evaluable data.||millimeters||95% Confidence Interval|Least Squares Mean
733504|NCT00420238|Secondary|Percent of Subjects Achieving Partial Remission at Weeks 14, 18, 24|Partial remission defined as a score of <20 millimeters (mm) on a scale of 0 to 100 mm in each of 4 domains: Visual Analog Scale (VAS) patient global assessment, VAS pain score (Total Back Pain), Bath Ankylosing Spondylitis Functional Index (BASFI) score, and Bath Ankylosing Spondylitis Disease Activities Index (BASDAI)-mean of two morning stiffness-related VAS scores. A negative score indicates an improvement in disease activity and a positive score indicates worsening.|Week 14, Week 18, Week 24|Open-label population; LOCF.||percent of participants|||Number
733505|NCT00420238|Secondary|Percent of Subjects Achieving Partial Remission at Weeks 2, 4, 8, 12|Partial remission defined as a score of <20 millimeters (mm) on a scale of 0 to 100 mm in each of 4 domains: Visual Analog Scale (VAS) patient global assessment, VAS pain score (Total Back Pain), Bath Ankylosing Spondylitis Functional Index (BASFI) score, and Bath Ankylosing Spondylitis Disease Activities Index (BASDAI)-mean of two morning stiffness-related VAS scores. A negative score indicates an improvement in disease activity and a positive score indicates worsening.|Week 2, Week 4, Week 8, Week 12|mITT; LOCF.||percent of participants|||Number
733506|NCT00420238|Secondary|Percent of Subjects Achieiving Assessment Ankylosing Spondylitis (ASAS) 70 at Weeks 14, 18, 24|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) patients; 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 70 = 70% improvement (vs. baseline) and an absolute change ≥ 20 units on a 0-100 scale (high disease activity) for ≥ 3 domains, and no worsening (absence of deterioration by >=20% and by >= 10 mm) in remaining domain.|Week 14, Week 18, Week 24|Open-label population; LOCF.||percent of participants|||Number
733507|NCT00420238|Secondary|Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 70 at Weeks 2, 4, 8, 12|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) patients; 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 70 = 70% improvement (vs. baseline) and an absolute change ≥ 20 units on a 0-100 scale (high disease activity) for ≥ 3 domains, and no worsening (absence of deterioration by >=20% and by >= 10 mm) in remaining domain.|Week 2, Week 4, Week 8, Week 12|mITT; LOCF.||percent of participants|||Number
733508|NCT00420238|Secondary|Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 50 at Weeks 14, 18, 24|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) patients; 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 50 = 50% improvement (vs. baseline) and an absolute (net) change ≥ 20 units on a 0-100 scale (high disease activity) for ≥ 3 domains, and no worsening (absence of deterioration by >=20% and by >=10 mm) in remaining domain.|Week 14, Week 18, Week 24|Open-label population; LOCF.||percent of particpants|||Number
733509|NCT00420238|Secondary|Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 50 at Weeks 2, 4, 8, 12|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) patients; 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 50 = 50% improvement (versus baseline) and an absolute (net) change ≥ 20 units on a 0-100 scale (high disease activity) for ≥ 3 domains, and no worsening (absence of deterioration by >=20% and by >=10 mm) in remaining domain.|Week 2, Week 4, Week 8, Week 12|mITT; LOCF.||percent of participants|||Number
733510|NCT00420238|Secondary|Percent of Subjects Acheiving Assessment Ankylosing Spondylitis (ASAS) 20 at Weeks 14, 18, 24|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) patients; 4 domains: patient global assessment of disease activity, pain, function, and inflammation. ASAS 20 = 20% improvement (versus baseline) and an absolute change (net improvement) ≥ 10 units (millimeters) on a 0-100 scale (100=high disease activity) for ≥ 3 domains, and no worsening (absence of deterioration by >=20% and by >=10 mm) in remaining domain.|Week 14, Week 18, Week 24|Open-label population: all subjects who received at least 1 dose of open test article (Etanercept). LOCF.||percent of participants|||Number
733511|NCT00420238|Secondary|Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 20 at Weeks 2, 4, 8, 12|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) patients; 4 domains: patient global assessment of disease activity, pain, function,and inflammation. ASAS 20 = 20% improvement (versus baseline) and an absolute change (net improvement) ≥ 10 millimeters (mm) on a 0-100 mm scale (100=high disease activity) for ≥ 3 domains, and no worsening (absence of deterioration by >=20% and by >= 10 mm) in remaining domain.|Week 2, Week 4, Week 8, Week 12|mITT; LOCF.||percent of participants|||Number
733512|NCT00420238|Secondary|Percent of Subjects Achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response|BASDAI subject assessment of discomfort, pain and fatigue was measured using a 100 millimeter Visual Analog Scale (VAS); range: 0=none to 100=very severe. BASDAI 50 response defined as at least a 50 percent (%) improvement (decrease) from baseline to observation (last observation carried forward) in the BASDAI. Baseline score minus score at observation divided by Baseline score * 100 = >=50%.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF.||percent of participants|||Number
733513|NCT00420238|Primary|Normalized Net Incremental Area Under the Curve (AUC) for the Bath Ankylosing Spondylitis Disease Activities Index (BASDAI) Between Randomization and Week 12|BASDAI subject asessment of discomfort, pain and fatigue measured using a 100 millimeter Visual Analog Scale; range: 0=none to 100=very severe. Normalized net incremental area under the curve (AUC) = area between baseline and the BASDAI curve as a function of time (randomization to Week 12); computed using the linear trapezoidal method. All areas above baseline and under the curve are positive and all areas below baseline and above the curve are negative. Net incremental AUC = sum of these areas; this result was then divided by the study duration of the patients; negative value = improvement.|Baseline, Week 2, Week 4, Week 8, Week 12|Modified Intent-To-Treat (mITT) population: includes all randomized subjects who received at least 1 dose of blinded study drug. Last observation carried forward (LOCF).||millimeters||95% Confidence Interval|Least Squares Mean
733514|NCT00420290|Secondary|Lean Body Mass (LBM)|LBM is a measurement of body composition in terms of lean body mass as determined using Dual Energy X-ray Absorptiometry (DEXA) performed 1 to 2 hours after dialysis.|month 1|The number of participants for analysis was based on those subjects who completed the 4-week study. The analysis was per protocol.||kg||Standard Deviation|Mean
733515|NCT00420290|Secondary|Serum Albumin|Albumin is a sensitive laboratory assay for serum levels of albumin, which is a biomarker of nutrition.|month 1|The number of participants for analysis was based on those subjects who completed the 4-week study. The analysis was per protocol.||g/dl||Standard Deviation|Mean
733516|NCT00420290|Secondary|Serum Prealbumin|Prealbumin is a sensitive laboratory assay for serum levels of prealbumin, which is a biomarker of nutrition.|month 1|The number of participants for analysis was based on those subjects who completed the 4-week study. The analysis was per protocol.||mg/dl||Standard Deviation|Mean
733517|NCT00420290|Secondary|Interleukin-6 (IL-6)|IL-6 is a sensitive laboratory assay for serum levels of interlukin-6, which is a pro-inflammatory cytokine that is used to evaluate the inflammatory response.|month 1|The number of participants for analysis was based on those subjects who completed the 4-week study. The analysis was per protocol.||pg/ml||Standard Deviation|Mean
733518|NCT00420290|Primary|High Sensitivity C-reactive Protein (hsCRP)|hsCRP is a sensitive laboratory assay for serum levels of C-reactive protein, which is a biomarker of inflammation.|month 1|The number of participants for analysis was based on those subjects who completed the 4-week study. The analysis was per protocol.||mg/dl||Standard Deviation|Mean
733519|NCT00420303|Primary|Change From Baseline in Patient Global Assessment of Disease Activity Score at Week 12|The patient global assessment of disease activity was measured using a 100mm Visual Analog Scale (VAS) ranging from 0=very good to 100=very bad. Change=12 week score minus baseline score. A negative score indicates an improvement in disease activity and a positive score indicates worsening.|Baseline and 12 weeks|All randomized patients who received at least 1 dose of test article.||units on scale||Standard Deviation|Mean
733520|NCT00420303|Secondary|Number of Patients Achieving a 50% Response on the Patient Global Assessment of Disease Activity|A response is defined as at least a 50% improvement (decrease) from baseline in the patient global assessment of disease activity. The patient global assessment of disease activity was measured using a 100mm Visual Analog Scale (VAS) ranging from 0=very good to 100=very bad.|12 weeks|All randomized patients who received at least 1 dose of test article.||patients|||Number
733521|NCT00420303|Primary|Normalized Net Incremental Area Under the Curve (AUC) for Patient Global Assessment of Disease Activity (PGA) Between Randomization and Week 12|PGA was measured using a 100mm Visual Analog Scale (VAS) ranging from 0=very good to 100=very bad. The normalized net incremental area under the curve of the PGA is the area between the baseline and the PGA curve as a function of time (week 2, 4, 8, 12). AUC was computed using the linear trapezoidal method. All the areas above the baseline and under the curve are positive and all the area below the baseline and above the curve are negative. The net incremental AUC is the sum of these areas. This result is then divided by the study duration of the patients. (negative value = improvement).|12 weeks|All randomized patients who received at least 1 dose of test article. Last observation carried forward (LOCF)||mm||Standard Deviation|Mean
733522|NCT00420316|Secondary|Number of Subjects Reporting Intussusception (IS)|Intussusception is defined as the telescoping of the intestine.|During the period starting from the end of the second follow-up up to the start of the study (end of July 2006 to beginning of January 2007)|The analysis was performed on the Total Cohort, which included all subjects who participated in this follow up study with at least one vaccine administration documented in the primary study.||Subjects|||Number
733523|NCT00420316|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|An SAE was any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.|During the study period for the long-term follow-up (i.e. 6 months)|The analysis was performed on the Total Cohort, which included all subjects who participated in this follow up study with at least one vaccine administration documented in the primary study.||Subjects|||Number
733524|NCT00420316|Secondary|Number of Subjects With Severe Gastroenteritis (GE)|Severe GE was defined as a GE episode requiring hospitalization and/or re-hydration therapy in a medical facility.|During the study period for the long-term follow-up (i.e. 6 months)|The analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all subjects from the ATP efficacy cohort of the primary study (102247) who entered into the efficacy surveillance period.||Subjects|||Number
733525|NCT00420316|Secondary|Number of Subjects With Severe Rotavirus Gastroenteritis (RVGE) With Non-G1 Serotype|Number of rotavirus gastroenteritis (RVGE) episodes caused by the wild-type rotavirus strain of non-G1 serotype and reported during the efficacy period, were presented by severity, using the Vesikari scale. The assessment of intensity of GE episodes was done using the 20-point Vesikari scale, according to which episodes with scores greater than or equal to (≥) 11 were labeled as severe.|During the study period for the long-term follow-up (i.e. 6 months)|The analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all subjects from the ATP efficacy cohort of the primary study (102247) who entered into the efficacy surveillance period.||Subjects|||Number
733526|NCT00420316|Secondary|Number of Subjects With Any Rotavirus Gastroenteritis (RVGE) With Non-G1 Serotype|Occurence of any rotavirus gastroenteritis (RVGE) caused by the circulating wild-type rotavirus strain of non-G1 serotype was assessed in terms of number of subjects experiencing diarrhoea with or without vomiting. Two occurrences of diarrhoea were classified as separate episodes if there were 5 or more diarrhoea-free days between the episodes.|During the study period for the long-term follow-up (i.e. 6 months)|The analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all subjects from the ATP efficacy cohort of the primary study (102247) who entered into the efficacy surveillance period.||Subjects|||Number
733527|NCT00420316|Secondary|Number of Subjects With Severe Rotavirus Gastroenteritis (RVGE) With G1 Serotype|Number of rotavirus gastroenteritis (RVGE) episodes caused by the wild-type rotavirus strain of serotype G1 and reported during the efficacy period, were presented by severity, using the Vesikari scale. The assessment of intensity of GE episodes was done using the 20-point Vesikari scale, according to which episodes with scores greater than or equal to (≥) 11 were labeled as severe.|During the study period for the long-term follow-up (i.e. 6 months)|The analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all subjects from the ATP efficacy cohort of the primary study (102247) who entered into the efficacy surveillance period.||Subjects|||Number
733528|NCT00420316|Secondary|Number of Subjects With Any Rotavirus Gastroenteritis (RVGE) With G1 Serotype|Occurence of any rotavirus gastroenteritis (RVGE) caused by the circulating wild-type rotavirus strain was assessed in terms of number of subjects experiencing diarrhoea with or without vomiting. Two occurrences of diarrhoea were classified as separate episodes if there were 5 or more diarrhoea-free days between the episodes. Only GE episodes in which wild-type RV strain of G1 serotype was identified in a stool specimen, were included in the efficacy analysis.|During the study period for the long-term follow-up (i.e. 6 months)|The analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all subjects from the ATP efficacy cohort of the primary study (102247) who entered into the efficacy surveillance period.||Subjects|||Number
733529|NCT00420316|Secondary|Number of Subjects With Severe Rotavirus Gastroenteritis (RVGE)|Number of rotavirus gastroenteritis (RVGE) episodes caused by the wild-type rotavirus strain and reported during the efficacy period, were presented by severity, using the Vesikari scale. The assessment of intensity of GE episodes was done using the 20-point Vesikari scale, according to which episodes with scores greater than or equal to (≥) 11 were labeled as severe.|During the study period for the long-term follow-up (i.e. 6 months)|The analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all subjects from the ATP efficacy cohort of the primary study (102247) who entered into the efficacy surveillance period.||Subjects|||Number
733530|NCT00420316|Primary|Number of Subjects With Any Rotavirus Gastroenteritis (RVGE)|Occurence of any rotavirus gastroenteritis (RVGE) caused by the circulating wild-type rotavirus strain was assessed in terms of number of subjects experiencing diarrhoea with or without vomiting. Two occurrences of diarrhoea were classified as separate episodes if there were 5 or more diarrhoea-free days between the episodes.|During the study period for the long-term follow-up (i.e. 6 months)|The analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all subjects from the ATP efficacy cohort of the primary study (102247) who entered into the efficacy surveillance period.||Subjects|||Number
733531|NCT00420342|Secondary|Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 130 mmHg (Posthoc Analysis)|Mean 24-hour ABPM SBP values were calculated in posthoc subgroup analyses for the following subgroups: Baseline mean 24-hour SBP from ABPM >112 mmHg, >116 mmHg, >120 mmHg, >124 mmHg, and >130 mmHg.|Baseline to Week 8|FAS population, for patients with baseline 24-hour ABPM means > 130 mmHg||mmHg||Standard Deviation|Mean
733532|NCT00420342|Secondary|Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 124 mmHg (Posthoc Analysis)|Mean 24-hour ABPM SBP values were calculated in posthoc subgroup analyses for the following subgroups: Baseline mean 24-hour SBP from ABPM >112 mmHg, >116 mmHg, >120 mmHg, >124 mmHg, and >130 mmHg.|Baseline to Week 8|FAS population, for patients with baseline 24-hour ABPM means > 124 mmHg||mmHg||Standard Deviation|Mean
733533|NCT00420342|Secondary|Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 120 mmHg (Posthoc Analysis)|Mean 24-hour ABPM SBP values were calculated in posthoc subgroup analyses for the following subgroups: Baseline mean 24-hour SBP from ABPM >112 mmHg, >116 mmHg, >120 mmHg, >124 mmHg, and >130 mmHg.|Baseline to Week 8|FAS population, for patients with baseline 24-hour ABPM means > 120 mmHg||mmHg||Standard Deviation|Mean
733534|NCT00420342|Secondary|Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 116 mmHg (Posthoc Analysis)|Mean 24-hour ABPM SBP values were calculated in posthoc subgroup analyses for the following subgroups: Baseline mean 24-hour SBP from ABPM >112 mmHg, >116 mmHg, >120 mmHg, >124 mmHg, and >130 mmHg.|Baseline to Week 8|FAS population, for patients with baseline 24-hour ABPM means > 116 mmHg||mmHg||Standard Deviation|Mean
733535|NCT00420342|Secondary|Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 112 mmHg (Posthoc Analysis)|Mean 24-hour ABPM SBP values were calculated in posthoc subgroup analyses for the following subgroups: Baseline mean 24-hour SBP from ABPM >112 mmHg, >116 mmHg, >120 mmHg, >124 mmHg, and >130 mmHg.|Baseline to Week 8|FAS population, for patients with baseline 24-hour ABPM means > 112 mmHg||mmHg||Standard Deviation|Mean
733536|NCT00420342|Secondary|Number of Subjects Who Are Sodium Sensitive at Baseline and Week 8|Sodium sensitivity was defined as ≥ 10 mmHg drop in mean arterial pressure, calculated from the office cuff BP values from Day 1 to Day 3. The number of subjects shifting from sodium sensitive at Baseline to sodium resistant at Week 8 or sodium resistant at Baseline to sodium sensitive at Week 8 by treatment group was reported.|8 weeks plus 3 days|FAS subjects from the one site which performed the sodium sensitivity analysis||participants|||Number
733537|NCT00420342|Secondary|Change From Baseline to Week 8 in Mean Day Time, Mean Nighttime and Mean Trough DBP From the ABPM Measurements|Diastolic blood pressure means were calculated during the intervals daytime (6 AM - 10 PM); nighttime (10 PM - 6 AM), and trough (mean of last 5 measurements in the 24-hour cycle)|Baseline to Week 8|Primary analysis used FAS; no imputation methods used; patients with missing data had no BP values after baseline; number of subjects analyzed was 27 in the 0.5mg DRSP group for nighttime values||mmHg||Standard Error|Median
733538|NCT00420342|Secondary|Change From Baseline to Week 8 in Mean Day Time, Mean Nighttime and Mean Trough SBP From the ABPM Measurements|Systolic blood pressure means were calculated during the intervals daytime (6 AM - 10 PM); nighttime (10 PM - 6 AM), and trough (mean of last 5 measurements in the 24-hour cycle)|Baseline to Week 8|Primary analysis used FAS; no imputation methods used; patients with missing data had no BP values after baseline; number of subjects analyzed was 27 in the 0.5mg DRSP group for nighttime values||mmHg||Standard Error|Mean
733539|NCT00420342|Secondary|Change From Baseline to Week 8 in Office Cuff SBP and DBP at Trough|Seated systolic and diastolic office cuff blood pressures were taken at each visit; the mean of three readings were used at each timepoint.|Baseline to Week 8|Primary analysis used FAS; no imputation methods used; patients with missing data had no BP values after baseline||mmHg||Standard Error|Mean
733540|NCT00420342|Secondary|Change From Baseline to Week 8 in Mean 24-hour DBP From the ABPM Measurements|The mean change in 24-hr Diastolic Blood Pressure (DBP) from Baseline to Week 8 was calculated for the full analysis set.|Baseline to Week 8|Primary analysis used FAS; no imputation methods used; patients with missing data had no BP values after baseline||mmHg||Standard Error|Mean
733541|NCT00420342|Primary|Change From Baseline to Week 8 in Mean 24-hour SBP From the ABPM Measurements in Per Protocol Population|The mean change in 24-hr ambulatory systolic blood pressure (SBP) from Baseline to Week 8 was calculated for the per protocol (PP) population. The change from baseline means was adjusted for center and baseline SBP.|Baseline to Week 8|Primary analysis was Per Protocol Population (PP); no imputation methods used; patients with missing data had no BP values after baseline.||mmHg||Standard Error|Mean
733542|NCT00420342|Primary|Change From Baseline to Week 8 in Mean 24-hour SBP From the Ambulatory Blood Pressure Monitoring (ABPM) Measurements in Full Analysis Set (FAS) Population|The mean change in 24-hr ambulatory systolic blood pressure (SBP) from Baseline to Week 8 was calculated for the full analysis set. The change from baseline means was adjusted for center and baseline SBP.|Baseline to Week 8|Primary analysis used Full Analysis Set (FAS), which follows ITT principles; no imputation methods used; patients with missing data had no Blood Pressure (BP) values after baseline||mmHg||Standard Error|Mean
733543|NCT00420407|Secondary|Secondary Objective is to Better Understand the Efficacy of Novel Endpoints of Resuscitation in the Management of Shock and the Ability of These Monitors to Predict Outcome After Trauma.||28 days||||||
733544|NCT00420407|Primary|The Primary Endpoint of This Study Will be Day 30 Mortality.||30 days|||Participants|||Number
733638|NCT00421408|Primary|Spine Bone Mineral Density Measured by Quantitative Computed Tomography (QCT) at 18 Months|There is no normative data for quantitative computed tomography it is based on local experience.|Measured at 18 months|All participants were analyzed using the mixed models method. For the Quantitative Computed Tomography (QCT) test only half of the participants were randomized to receive it.||mg/cm^3||Standard Error|Least Squares Mean
733545|NCT00420420|Other Pre-specified|Baseline: Cognition Summary Score (CSS)|The CSS was used to evaluate cognitive function as measured by the mean change from Baseline to Week 4 in the CSS total score. The CSS was derived from the correct sequence percentage from the Route Test and 6 of the CNTB scores (the CSS was scored as the mean of the 7 scores). CSS scores can range from 0 to 100, higher scores (and positive changes from baseline) indicate better performance.|Baseline|Full Analysis Set: All patients who were randomized, took at least one dose of study medication, and had at least one efficacy measurement at either Baseline, Week 2 or Week 4. Patients were counted in the treatment group to which they were randomized.||units on a scale||Standard Deviation|Mean
733546|NCT00420420|Other Pre-specified|Baseline: ADAS-Cog Total Score|The ADAS-Cog, scored as the total score of 11 tasks including mazes was used to evaluate cognitive function, as measured by the mean change from Baseline to Week 4 in the ADAS-Cog total score. The ADAS-Cog total score ranges from 0 to 70, with higher total scores indicating more impairment. Lower scores (and negative changes from Baseline) indicate better performance.|Baseline|Full Analysis Set: All patients who were randomized, took at least one dose of study medication, and had at least one efficacy measurement at either Baseline, Week 2 or Week 4. Patients were counted in the treatment group to which they were randomized.||units on a scale||Standard Deviation|Mean
733547|NCT00420420|Other Pre-specified|Baseline: Short CNTB Summary Score.|The CNTB was used to evaluate cognitive function, as measured by the mean change from Baseline to Week 4 in the short CNTB summary score. The short CNTB summary score was scored as the mean score across 5 modules: Word List Learning-Selective Reminding, Word List Learning-Delayed Recall, Simple Reaction Time, Choice Reaction Time, and Visual Memory subtests. The short CNTB summary score ranges from 0 to 100, with higher scores (and positive changes from baseline) indicating better performance.|Baseline|Full Analysis Set: All patients who were randomized, took at least one dose of study medication, and had at least one efficacy measurement at either Baseline, Week 2 or Week 4. Patients were counted in the treatment group to which they were randomized.||units on a scale||Standard Deviation|Mean
733548|NCT00420420|Primary|Week 4 Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog): ADAS-Cog Total Score|The ADAS-Cog, scored as the total score of 11 tasks including mazes was used to evaluate cognitive function, as measured by the mean change from Baseline to Week 4 in the ADAS-Cog total score. The ADAS-Cog total score ranges from 0 to 70, with higher total scores indicating more impairment. Lower scores (and negative changes from Baseline) indicate better performance.|Baseline and Week 4|Full Analysis Set: All patients who were randomized, took at least one dose of study medication, and had at least one efficacy measurement at either Baseline, Week 2 or Week 4. Patients were counted in the treatment group to which they were randomized.||units on a scale||Standard Error|Mean
733549|NCT00420420|Secondary|Week 4 Change From Baseline in Cognition Summary Score (CSS)|The CSS was used to evaluate cognitive function as measured by the mean change from Baseline to Week 4 in the CSS total score. The CSS was derived from the correct sequence percentage from the Route Test and 6 of the CNTB scores (the CSS was scored as the mean of the 7 scores). CSS scores can range from 0 to 100, higher scores (and positive changes from baseline) indicate better performance.|Baseline and Week 4|Full Analysis Set: All patients who were randomized, took at least one dose of study medication, and had at least one efficacy measurement at either Baseline, Week 2 or Week 4. Patients were counted in the treatment group to which they were randomized.||units on a scale||Standard Error|Mean
733550|NCT00420420|Primary|Week 4 Change From Baseline in Computerized Neuropsychological Test Battery (CNTB): Short CNTB Summary Score.|The CNTB was used to evaluate cognitive function, as measured by the mean change from Baseline to Week 4 in the short CNTB summary score. The short CNTB summary score was scored as the mean score across 5 modules: Word List Learning-Selective Reminding, Word List Learning-Delayed Recall, Simple Reaction Time, Choice Reaction Time, and Visual Memory subtests. The short CNTB summary score ranges from 0 to 100, with higher scores (and positive changes from baseline) indicating better performance.|Baseline and Week 4|Full Analysis Set: All patients who were randomized, took at least one dose of study medication, and had at least one efficacy measurement at either Baseline, Week 2 or Week 4. Patients were counted in the treatment group to which they were randomized.||units on a scale||Standard Error|Mean
733551|NCT00420459|Secondary|The Vineland Maladaptive Behavior Subscales|The Vineland Adaptive Behavior Scales include an optional Maladaptive Behavior Index with 27 items. The Maladaptive Behavior Index is a composite of Internalizing, Externalizing, and other types of undesirable behavior that may interfere with the individual's adaptive functioning. The Maladaptive Behavior subscale yields raw scores (0-27).|Week 12|Data for this outcome measure are unavailable because the data file was lost during a server migration.|||||
733552|NCT00420459|Secondary|The Vineland Adaptive Behavior Scales|Vineland Adaptive Behavior Scales are a valid and reliable test to measure a person's adaptive level of functioning. Vineland-II forms aid in diagnosing and classifying intellectual and developmental disabilities and other disorders, such as autism spectrum disorders and developmental delays. The content and scales are organized within a 4 domain structure: Communication, Daily Living, Socialization and Motor Skills. The adaptive behavior composite standard score is computed from the sum of standard scores from the domains and converted into the adaptive behavior composite standard score. Higher scores indicate a higher adaptive level of functioning.|Screen Visit|Data for this outcome measure are unavailable because the data file was lost during a server migration.|||||
733553|NCT00420459|Secondary|Social Responsiveness Scale|The 65-item SRS is a standardized measure of the core symptoms of autism. Each item is scored on a 4-point Likert scale. The score of each individual item is summed to create a total raw score. A total scores results are as follows: 0-62: Within normal limits 63-79: Mild range of impairment 80-108: Moderate range of impairment 109-149: Severe range of impairment|Obtained at Baseline and Week 12|||units on a scale||Standard Deviation|Mean
733554|NCT00420459|Secondary|The Children's Yale-Brown Obsessive Compulsive Scale|The CY-BOCS PDD has been utilized in a largescale clinical treatment study of repetitive behavior in idiopathic ASDs. CYBOCS-PDD scores range from 0 to 20 and measure repetitive/compulsive behavior and not obsessions. Higher score indicate worse outcome.|Obtained at Baseline and Week 12|||units on a scale||Standard Deviation|Mean
733639|NCT00421408|Primary|Spine Bone Mineral Density Measured by Quantitative Computed Tomography (QCT) at Baseline|There is no normative data for quantitative computed tomography it is based on local experience.|Measured at 0 months|All participants were analyzed using the mixed models method. For the Quantitative Computed Tomography (QCT) test only half of the participants were randomized to receive it.||mg/cm^3||Standard Error|Least Squares Mean
733555|NCT00420459|Primary|Clinical Global Impressions- Severity|The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.|Obtained at Baseline and Week 12|||units on a scale||Standard Deviation|Mean
733556|NCT00420459|Primary|Aberrant Behavior Checklist|The Aberrant Behavior Checklist (ABC) is a 58-item measure of maladaptive behaviors and is used as a measure of drug effects. The ABC has 5 subscales: Social Withdrawal (16 items) ranging from 0 (not at all) to 48 (severe), Irritability (15 items) ranging from 0 (not at all) to 45 (severe), Inappropriate Speech (4 items) ranging from 0 (not at all) to 12 (severe), Hyperactivity (16 items) ranging from 0 (not at all) to 48 (severe), and Stereotypy (7 items) ranging from 0 (not at all) to 21 (severe). Items are rated from 0 (not at all) to 3 (severe).|Obtained at Baseline and Week 12|||units on a scale||Standard Deviation|Mean
733557|NCT00420511|Secondary|Proportion of Patients Achieving Sustained Normoglycemia Off Medication at 1-week Post-insulin Therapy||1 year||||||
733558|NCT00420511|Secondary|Time to Loss of Glycemic Control||1 year||||||
733559|NCT00420511|Secondary|Area-under-the-glucose-curve (AUCglucose) on Meal Test at 1 Year||1 year||||||
733560|NCT00420511|Secondary|Fasting Blood Glucose at 48 Weeks||48 weeks|||mmol/l||Inter-Quartile Range|Median
733561|NCT00420511|Secondary|Insulinogenic Index Divided by HOMA-IR at 48 Weeks|Insulinogenic index was calculated as the incremental change in insulin from 0 to 30 minutes divided by the incremental change in glucose over the same period of time. Insulinogenic index divided by HOMA-IR provides an additional measure of beta-cell function. A higher value indicates better beta-cell function|48 weeks|||index of beta-cell function||Inter-Quartile Range|Median
733562|NCT00420511|Primary|Preservation of Beta-cell Function Measured by Area-under-the-curve (C-peptide/Glucose)/HOMA-IR|Area-under-the-C-peptide-curve (AUCCpep) and area-under-the-glucose-curve (AUCgluc) from 0 to 240 minutes during meal tests were calculated using the trapezoidal rule. Insulin resistance was assessed using the Homeostasis Model Assessment of Insulin Resistance (HOMA-IR). Beta-cell function was assessed using the ratio of total AUCCpep to AUCgluc divided by HOMA-IR (AUCCpep/gluc/HOMA-IR), a measure of insulin secretion in the context of ambient insulin sensitivity, analogous to the disposition index and adaptation index. Higher AUCCpep/gluc/HOMA-IR is indicative of better beta-cell function.|48 weeks|||index of beta-cell function||Inter-Quartile Range|Median
733563|NCT00420628|Secondary|Assessment of Ocular Signs in the Study Eye - Visit 3|Lid edema, lid erythema, palpebral conjunctival injection, meibomium plugging measured on a scale of 0-4 none, minimal, mild, moderate, severe.|Visit 3 (day 15)|Efficacy sample - Study eye||Units on a scale 0-4||Standard Deviation|Mean
733564|NCT00420628|Secondary|Assessment of Ocular Signs in the Study Eye - Visit 2|Lid edema, lid erythema, palpebral conjunctival injection, meibomium plugging measured on a scale of 0-4 none, minimal, mild, moderate, severe.|Visit 2 (day 8)|Efficacy population - Study eye||Units on a scale 0-4||Standard Deviation|Mean
733565|NCT00420628|Secondary|Assessment of Ocular Signs in the Study Eye - Visit 1|Lid edema, lid erythema, palpebral conjunctival injection, meibomium plugging measured on a scale of 0-4 none, minimal, mild, moderate, severe.|Visit 1 (day 1)|Efficacy sample, non-missing data||Units on a scale 0-4||Standard Deviation|Mean
733566|NCT00420628|Primary|Treatment Emergent Adverse Events|Study eye - Safety Population, At all visits 1,2,3|day 1, day 8, day 15|Safety population, Study eye||participants|||Number
733567|NCT00420628|Secondary|Investigators Global Assessment of the Clinical Condition|The efficacy endpoints for this study consisted of reduction of inflammation as measured by the IGA of the clinical condition. Changes in clinical condition measured as improved, unchanged or worsened.|Visit 3, day 8|Efficacy Sample, subjects with non-missing data. Day 15 (Visit 3)||Participants|||Number
733568|NCT00420745|Secondary|Serum Anti–Rotavirus IgA Antibody Concentration.|Anti-rotavirus IgA antibody concentrations are given as geometric mean concentrations (GMC) with 95% Confidence Intervals, calculated on all subjects.|At Visit 3, 1 month after Dose 2 of Rotarix vaccine/Placebo|The analyses were performed on the According-to-Protocol immunogenicity cohort. The anti-rotavirus IgA antibody GMC for Placebo Group was below the assay cut-off (<20 U/mL), so could not be computed.||U/mL||95% Confidence Interval|Geometric Mean
733569|NCT00420745|Secondary|Seroconversion to Anti-rotavirus Immunoglobulin A (IgA) Antibody.|Number of subjects with anti-rotavirus IgA antibody concentration ≥ 20 Units/milliliter (U/mL).|At Visit 3, 1 month after Dose 2 of Rotarix vaccine/Placebo|The analyses were performed on the According-to-Protocol immunogenicity cohort that included all subjects with at least one study vaccine or placebo administered, for whom immunogenicity data were collected and available and who complied with the inclusion criteria defined in the protocol.||subjects|||Number
733570|NCT00420745|Secondary|Number of Subjects for Whom Presence of Rotavirus (RV) Gastroenteritis (GE) Was Detected in Stools.|Gastroenteritis (GE): diarrhoea with or without vomiting. Rotavirus (RV) GE: A GE episode was a RV GE if a stool sample taken during or not later than 7 days after the episode was RV positive by Enzyme Linked Immunosorbent Assay.|From Dose 1 up to 1 month after Dose 2 of Rotarix vaccine/Placebo|The analyses were performed on the Total Vaccinated Cohort that included all the subjects with at least one study vaccine or placebo administration documented.||subjects|||Number
733571|NCT00420745|Secondary|Number of Subjects for Whom Each Type of Solicited Symptom Was Reported.|Solicited symptoms included Diarrhea (3 or more looser than normal stools/day), Fever (axillary temperature ≥ 37.5 degrees Celsius (°C)), Irritability, Loss of appetite, and Vomiting|Within 15 days after each Rotarix vaccine/Placebo dose.|The analyses were performed on the Total vaccinated cohort for the safety and the immunogenicity subset that included all subjects with at least one study vaccine or placebo administered and for whom solicited symptoms were collected.||subjects|||Number
733572|NCT00420745|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs), According to Medical Dictionary for Regulatory Activities (MedDRA) Classification.|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Within 31 days after any Rotarix vaccine/Placebo dose.|The analyses were performed on the Total Vaccinated Cohort that included all the subjects with at least one study vaccine or placebo administration documented.||subjects|||Number
733573|NCT00420745|Primary|Number of Subjects Reporting Any Serious Adverse Events (SAEs).|"An SAE is any untoward medical occurrence that:
results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above."|From Day 0 up to 1 month after Dose 2 of Rotarix vaccine/Placebo|The analyses were performed on the Total Vaccinated Cohort that included all the subjects with at least one study vaccine or placebo administration documented.||subjects|||Number
733574|NCT00420784|Secondary|Maximum (Cmax), Minimum (Cmin) and Average (Cavg) Plasma Concentration of Telaprevir|Only subjects who received telaprevir were to be analyzed for this outcome. Maximum, minimum and average plasma concentrations observed during assessment period were reported.|Week 2, 4, 8, 12, 16, 24|Pharmacokinetic population included all subjects who provided pharmacokinetic assessments and had evaluable and interpretable data.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
733575|NCT00420784|Secondary|Number of Subjects With Viral Relapse|Viral relapse was defined as having detectable HCV RNA during antiviral follow-up. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).|After last dose of study drug up to 24 week antiviral follow-up (up to Week 72)|Analysis population included subjects who completed their assigned study drug treatment and had undetectable HCV RNA at the completion of treatment (up to Week 48).||participants|||Number
733576|NCT00420784|Secondary|Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)|"AE: any adverse change from the subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Study drug includes all investigational agents (including placebo, if applicable) administered during the course of the study."|Baseline up to 2 weeks after last dose of study drug (up to Week 50)|Full Analysis Set = subjects who received at least 1 dose of study drug.||participants|||Number
733577|NCT00420784|Secondary|Percentage of Subjects With Undetectable Plasma HCV RNA|"Percentage of subjects with undetectable HCV RNA at 24 weeks after last dose of study drug for treatment group PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week and at 48 weeks after last dose of study drug for treatment groups Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week, Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week and Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week were presented. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL)."|Up to Week 96 (24 weeks after last dose of study drug for PBO group; 48 weeks after last dose of study drug for telaprevir groups)|Full Analysis Set = subjects who received at least 1 dose of study drug.||percentage of participants|||Number
733578|NCT00420784|Secondary|Percentage of Subjects With Undetectable Plasma HCV RNA at Completion of Study Drug Dosing|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).|Completion of study drug dosing (up to Week 48)|Full Analysis Set = subjects who received at least 1 dose of study drug.||percentage of participants|||Number
733579|NCT00420784|Primary|Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Study Drug Dosing|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).|24 weeks after the completion of study drug dosing (up to Week 72)|Full Analysis Set = subjects who received at least 1 dose of study drug||percentage of participants|||Number
733580|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Body Image Scale|EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale. For the body image scale, higher scores = better body image.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.||units on a scale||Standard Deviation|Mean
733581|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Future Perspective Scale|EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale. For the future perspective scale, higher score = better perspective of the future.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.||units on a scale||Standard Deviation|Mean
733582|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Side Effects Scale|EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale; higher score for the side effects scale = higher level of symptomatology.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.||units on a scale||Standard Deviation|Mean
733583|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale|EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale; higher score for the disease symptoms scale = higher level of symptomatology.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.||units on a scale||Standard Deviation|Mean
733584|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Quality of Life Scale|EORTQ QLC-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better quality of life.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.||units on a scale||Standard Deviation|Mean
733585|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Financial Problems Scale|EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a problem scale like the financial problems scale = higher level of financial problems.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.||units on a scale||Standard Deviation|Mean
733586|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Appetite Loss Scale|EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the appetite loss scale = higher level of symptomatology/problems.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.||units on a scale||Standard Deviation|Mean
733587|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Dyspnoea Scale|EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the dyspnoea scale = higher level of symptomatology/problems.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.||units on a scale||Standard Deviation|Mean
733588|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Insomnia Scale|EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the insomnia scale = higher level of symptomatology/problems.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.||units on a scale||Standard Deviation|Mean
733589|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Diarrhea Scale|EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the diarrhea scale = higher level of symptomatology/problems.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.||units on a scale||Standard Deviation|Mean
733590|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Constipation Scale|EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the constipation scale = higher level of symptomatology/problems.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.||units on a scale||Standard Deviation|Mean
733591|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Nausea/Vomiting Scale|EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the nausea/vomiting scale = higher level of symptomatology/problems.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.||units on a scale||Standard Deviation|Mean
733592|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Pain Scale|EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the pain scale = higher level of symptomatology/problems.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.||units on a scale||Standard Deviation|Mean
733593|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Scale|EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the fatigue scale = higher level of symptomatology/problems.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.||units on a scale||Standard Deviation|Mean
733594|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Social Functioning Scale|EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better level of social functioning.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.||units on a scale||Standard Deviation|Mean
733595|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Cognitive Functioning Scale|EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better level of cognitive functioning.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.||units on a scale||Standard Deviation|Mean
733596|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Emotional Functioning Scale|EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better level of emotional functioning.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.||units on a scale||Standard Deviation|Mean
733597|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Role Functioning Scale|EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score=better level of role functioning.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.||units on a scale||Standard Deviation|Mean
733598|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Physical Functioning Scale|EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. EORTC QLQ-C30 includes functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and other (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4-point scale (1 ‘Not at All’ to 4 ‘Very Much’); 2 questions used 7-point scale (1 ‘Very Poor’ to 7 ‘Excellent’). Scores are averaged, and transformed to 0-100 scale; higher score=better level of physical functioning.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.||units on a scale||Standard Deviation|Mean
733599|NCT00420849|Secondary|Time to First Venous Thromboembolic Treatment-Emergent Adverse Event (TEAE)|Time between first dose and when a TEAE for venous thromboembolic event was reported. The mean is the univariate mean without adjusting for censoring. The treatment duration was used for censored participants.|up to 124 weeks|Safety population||weeks||Standard Deviation|Mean
733600|NCT00420849|Secondary|Participants With Adverse Events of Special Interest: Venous Thromboembolic Events|Number of participants with at least one venous thromboembolic treatment-emergent adverse event (TEAE), and number of participants reporting AEs coded to preferred terms that comprise the search terms for venous thromboembolic events in MedDRA version 9.0 are listed. A participant with multiple occurrences of a TEAE was counted only once for that category.|up to 124 weeks|Safety population||participants|||Number
733601|NCT00420849|Secondary|Time to First Peripheral Neuropathy Treatment-Emergent Adverse Event (TEAE)|Time between first dose and when a TEAE for peripheral neuropathy was reported. The mean is the univariate mean without adjusting for censoring. The treatment duration was used for censored participants.|up to 124 weeks|Safety population||weeks||Standard Deviation|Mean
733602|NCT00420849|Secondary|Participants With Adverse Events of Special Interest: Peripheral Neuropathy|Number of participants with at least one peripheral neuropathy treatment-emergent adverse event (TEAE), and number of participants reporting AEs coded to preferred terms that comprise the search terms for peripheral neuropathy in MedDRA version 9.0 are listed. A participant with multiple occurrences of a TEAE was counted only once for that category.|up to 124 weeks|Safety population||participants|||Number
733603|NCT00420849|Primary|Overall Incidence of Treatment-emergent Adverse Events (TEAEs), by Severity, Seriousness, and Relationship to Treatment|"Counts of study participants who had treatment-emergent adverse events (TEAEs) defined as any reported AE that started on or after the first day of study drug dosing. A participant with multiple occurrences of an adverse event within a category is counted only once in that category.
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) was used by investigators to assess TEAEs. Severity scale ranges from 0 (none) to 5 (death). Grade 3=severe AE; Grade 4=life threatening or disabling AE; Grade 5=death."|up to 123 weeks|Safety population||participants|||Number
733604|NCT00420927|Secondary|Number of Subjects With No Radiographic Progression (Change From Baseline in mTSS of Less Than or Equal to 0.5), Normal Function (HAQ-DI Less Than 0.5), and DAS28 Remission (DAS28 Less Than 2.6) at Week 78|In the Health Assessment Questionnaire Disability Index (HAQ-DI), a score of 0-1 represents mild to moderate, 1-2 moderate to severe, 2-3 severe to very severe disability. The modified Total Sharp score (mTSS) ranges from 0 (no joint damage) to 448 (severe joint damage). The Disease Activity Score (DAS28) ranges from 0.49 to 9.07, with scores less than 2.6 indicating clinical remission.|Week 78|||Participants|||Number
733665|NCT00421928|Secondary|Change From Baseline in Sleep Latency Time in Hours Over the Last Week of the Maintenance Period at Week 12.|"A Sleep Questionniare addressed the following question: How long after bedtime/lights out did you fall asleep last night (hours)? 12 week endpoint-mean changes from baseline at endpoint for sleep latency. Decrease in time(hours) indicates improvement."|Baseline and 12 week endpoint|ITT||Hours||Standard Deviation|Mean
733605|NCT00420927|Secondary|Number of Subjects With No Radiographic Progression (Change From Baseline in mTSS of Less Than or Equal to 0.5), Normal Function (HAQ-DI Less Than or Equal to 0.5), and ACR70 Response at Week 78|In the Health Assessment Questionnaire Disability Index (HAQ-DI), a score of 0-1 represents mild to moderate, 1-2 moderate to severe, 2-3 severe to very severe disability. The modified Total Sharp score (mTSS) ranges from 0 (no joint damage) to 448 (worst joint damage). American College of Rheumatology 70% (ACR70) response indicates at least 70% improvement in tender and swollen joint counts and at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; HAQ-DI; and C-reactive protein.|Week 78|||Participants|||Number
733606|NCT00420927|Secondary|Number of Subjects With No Radiographic Progression (Change From Baseline in mTSS of Less Than or Equal to 0.5) and Normal Function (HAQ-DI Less Than 0.5) at Week 78|In the Health Assessment Questionnaire Disability Index (HAQ-DI), participants rated their ability to perform daily tasks on a scale of 0 (without any difficulty) to 3 (unable to do). A mean score of 0-1 represents mild to moderate functional disability, 1-2 represents moderate to severe, 2-3 severe to very severe disability. For the modified Total Sharp score (mTSS), x-rays of hand/wrist and feet joints are scored for erosions (0 to 5) and joint space narrowing (0 to 4). The erosion score and the narrowing score are added to determine the total score, which ranges from 0 (no damage) to 448.|Week 78|||Participants|||Number
733607|NCT00420927|Secondary|Change From Baseline in Synovitis Score According to the Rheumatoid Arthritis Magnetic Resonance Imaging (RA MRI) Scoring System (RAMRIS) at Week 78|Synovitis was assessed using high-field magnetic resonance imaging (MRI) of the hand and wrist. Images were read and scored according to the Outcomes Measures in Rheumatology Clinical Trials' Rheumatoid Arthritis MRI Scoring System (OMERACT RAMRIS). Synovitis in the wrist and finger joints in the most affected hand was scored from 0 (normal) to 3 (severe), for a maximum total score of 21.|Baseline to Week 78|The analysis is based on the Primary Analysis Set, a subset of the ITT Analysis Set that includes subjects who participated in the 78-week HF MRI substudy and whose Baseline HF MRI data were collected on or before the first study drug dose. Observed scores are used in the analysis.||Scores on a scale||Standard Deviation|Mean
733608|NCT00420927|Secondary|Change From Baseline in SDAI Score at Week 78|The SDAI is calculated using number of swollen joints (28 joints assessed), number of tender joints (28 joints assessed), patient's global assessment of disease activity, physician's global assessment of disease activity, and acute phase reactant (C-reactive protein). Scores range from 0.1 to 86.0, with a higher score reflecting worsening disease.|Baseline to Week 78|||Scores on a scale||Standard Deviation|Mean
733609|NCT00420927|Secondary|Change From Baseline in CDAI Score at Week 78|The CDAI is calculated using number of swollen joints (28 joints assessed), number of tender joints (28 joints assessed), patient's global assessment of disease activity, and physician's global assessment of disease activity. Scores range from 0 to 76.0, with a higher score reflecting worsening disease.|Baseline to Week 78|||Scores on a scale||Standard Deviation|Mean
733610|NCT00420927|Secondary|Number of Subjects With Simplified Disease Activity Index (SDAI) Remission (SDAI Less Than or Equal to 3.3) at Week 78|The SDAI is calculated using number of swollen joints (28 joints assessed), number of tender joints (28 joints assessed), patient's global assessment of disease activity, physician's global assessment of disease activity, and acute phase reactant (C-reactive protein). Scores range from 0.1 to 86.0, with a higher score reflecting worsening disease.|Week 78|||Participants|||Number
733611|NCT00420927|Secondary|Number of Subjects With Clinical Disease Activity Index (CDAI) Remission (CDAI Less Than or Equal to 2.8) at Week 78|The CDAI is calculated using number of swollen joints (28 joints assessed), number of tender joints (28 joints assessed), patient's global assessment of disease activity, and physician's global assessment of disease activity. Scores range from 0 to 76.0, with a higher score reflecting worsening disease.|Week 78|||Participants|||Number
733612|NCT00420927|Secondary|Number of Subjects With Simplified Disease Activity Index (SDAI) Low Disease Activity (SDAI Less Than or Equal to 11) at Week 78|The SDAI is calculated using number of swollen joints (28 joints assessed), number of tender joints (28 joints assessed), patient's global assessment of disease activity, physician's global assessment of disease activity, and acute phase reactant (C-reactive protein). Scores range from 0.1 to 86.0, with a higher score reflecting worsening disease.|Week 78|||Participants|||Number
733613|NCT00420927|Secondary|Number of Subjects With Clinical Disease Activity Index (CDAI) Low Disease Activity (CDAI Less Than or Equal to 10) at Week 78|The CDAI is calculated using number of swollen joints (28 joints assessed), number of tender joints (28 joints assessed), patient's global assessment of disease activity, and physician's global assessment of disease activity. Scores range from 0 to 76.0, with a higher score reflecting worsening disease.|Week 78|||Participants|||Number
733614|NCT00420927|Secondary|Change From Baseline in DAS28 Score at Week 78|The Disease Activity Score (DAS28) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein level, and the patient's global assessment of disease activity. The calculated range of DAS28 is 0.49 to 9.07. A DAS28 less than 2.6 indicates clinical remission, DAS28 2.6 to 3.2 indicates low disease activity, DAS28 3.2 to less than 5.1 indicates moderate disease activity, and DAS28 of 5.1 or greater indicates high disease activity.|Baseline to Week 78|||Scores on a scale||Standard Deviation|Mean
733615|NCT00420927|Secondary|Number of Subjects Meeting American College of Rheumatology 70% (ACR70) Response Criteria at Week 78|Subjects were responders if they had: greater than or equal to 70% improvement in tender joint count; greater than or equal to 70% improvement in swollen joint count; and greater than or equal to 70% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant (C-reactive protein).|Week 78|ITT Population, nonresponder imputation||Participants|||Number
733616|NCT00420927|Secondary|Number of Subjects Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 78|Subjects were responders if they had: greater than or equal to 50% improvement in tender joint count; greater than or equal to 50% improvement in swollen joint count; and greater than or equal to 50% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant (C-reactive protein).|Week 78|ITT Population, nonresponder imputation||Participants|||Number
733617|NCT00420927|Secondary|Number of Subjects Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 78|Subjects were responders if they had greater than or equal to 20% improvement in tender joint count; greater than or equal to 20% improvement in swollen joint count; and greater than or equal to 20% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant (C-reactive protein).|Week 78|ITT Population, nonresponder imputation||Participants|||Number
733618|NCT00420927|Secondary|Number of Subjects With No Radiographic Progression (Change From Baseline in mTSS Less Than or Equal to 0.5) at Week 78|For the modified Total Sharp score (mTSS), x-rays of hand/wrist and feet joints are scored for erosions (0 to 5) and joint space narrowing (0 to 4). The erosion score and the narrowing score are added to determine the total score, which ranges from 0 (no damage) to 448. An increase in mTSS from baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.|Week 78|ITT Population, nonresponder imputation||Participants|||Number
733619|NCT00420927|Secondary|Number of Subjects With DAS28 Remission (DAS28 Less Than 2.6) at Week 78|The Disease Activity Score (DAS28) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein level, and the patient's global assessment of disease activity. The calculated range of DAS28 is 0.49 to 9.07. A DAS28 less than 2.6 indicates clinical remission, DAS28 2.6 to 3.2 indicates low disease activity, DAS28 3.2 to less than 5.1 indicates moderate disease activity, and DAS28 of 5.1 or greater indicates high disease activity.|Week 78|ITT Population, nonresponder imputation||Participants|||Number
733620|NCT00420927|Secondary|Number of Subjects With DAS28 Low Disease Activity (DAS28 Less Than 3.2) at Week 78|The Disease Activity Score (DAS28) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein level, and the patient's global assessment of disease activity. The calculated range of DAS28 is 0.49 to 9.07. A DAS28 less than 2.6 indicates clinical remission, DAS28 2.6 to 3.2 indicates low disease activity, DAS28 3.2 to less than 5.1 indicates moderate disease activity, and DAS28 of 5.1 or greater indicates high disease activity.|Week 78|ITT Population, Nonresponder imputation||Participants|||Number
733621|NCT00420927|Secondary|Number of Subjects With Low Disease Activity (DAS28 Less Than 3.2) and No Radiographic Progression From Baseline (Change in mTSS Less Than or Equal to 0.5) at Week 78, Arm 2 vs. Arm 1|The Disease Activity Score (DAS28) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein level, and the patient's global assessment of disease activity. The calculated range of DAS28 is 0.49 to 9.07, with scores below 3.2 indicating low disease activity. For the modified Total Sharp score (mTSS), x-rays of hand/wrist and feet joints are scored for erosions (0 to 5) and joint space narrowing (0 to 4). The erosion score and the narrowing score are added to determine the total score, which ranges from 0 (no damage) to 448.|Week 78|||Participants|||Number
733622|NCT00420927|Primary|Number of Subjects With Low Disease Activity (DAS28 Less Than 3.2) and No Radiographic Progression From Baseline (Change in mTSS Less Than or Equal to 0.5) at Week 78, Arm 2 vs. Arm 4|The Disease Activity Score (DAS28) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein level, and the patient's global assessment of disease activity. The calculated range of DAS28 is 0.49 to 9.07, with scores below 3.2 indicating low disease activity. For the modified Total Sharp score (mTSS), x-rays of hand/wrist and feet joints are scored for erosions (0 to 5) and joint space narrowing (0 to 4). The erosion score and the narrowing score are added to determine the total score, which ranges from 0 (no damage) to 448.|Week 78|The analysis was performed on the ITT Population comprised of all subjects who entered Period 2 and received at least 1 dose of study drug (blinded or open-label) during Period 2. Nonresponder imputation was used for missing data.||Participants|||Number
733623|NCT00420992|Primary|Mean Change From Randomization to 12 Weeks Following Randomization in Diary Brief Pain Inventory Score of Average Pain (Daily Scores of Average Pain Averaged Over 7 Days)|Change in pain intensity scale. Average pain intensity over last 24 hours rated daily from 0=no pain to 10=worst pain.|randomization to 12 weeks following randomization|intent to treat (ITT)||units on scale||Standard Deviation|Mean
733624|NCT00421174|Secondary|Pro-inflammatory Markers of Pulmonary Disease, in Both BAL Fluid and Plasma||Day 28|No data collected|||||
733625|NCT00421174|Secondary|Dermatologic Reaction||Day 28|No data collected|||||
733626|NCT00421174|Secondary|Overall Mortality||Year 2|||participants|||Number
733627|NCT00421174|Secondary|Incidence of Relapse|Percentage of patients who experience relapse. Deaths without relapse are considered as a competing risk.|Year 1|||Participants|||Count of Participants
733628|NCT00421174|Secondary|Incidence of Graft-vs-Host-Disease (GVHD)||Year 1|||percentage of participants||95% Confidence Interval|Number
733629|NCT00421174|Secondary|Incidence of Toxicity||Day 56|||Toxcities|Total number of toxicities||Number
733630|NCT00421174|Secondary|Incidence of Infection||Day 56|||Infections|Total number of infections||Number
733631|NCT00421174|Secondary|Overall Survival|Percentage of patients that survived after one year|Year 1|||percentage of participants||95% Confidence Interval|Number
733632|NCT00421174|Secondary|Corticosteroid Dose|Patients were treated with systemic corticosteroids with methylprednisolone at 2 mg/kg/day on day 0, with taper allowed after day 7.|Day 14 and 28|||mg/kg/day||Full Range|Median
733633|NCT00421174|Secondary|Discontinuation of Supplemental Oxygen|The “time required to discontinue supplemental oxygen” will be measured in the number of days from study entry.|Day 56|||days||Full Range|Median
733634|NCT00421174|Secondary|Response to Therapy|Response will be defined as the ability to survive to Day 56 of study, plus the ability to completely discontinue all supplemental oxygen support for > 72 consecutive hours during this time period.|Day 56|||percentage of participants||95% Confidence Interval|Number
733635|NCT00421174|Primary|Response Rate|Response will be defined as survival to Day 28 of study, plus discontinuation of all supplemental oxygen support for more than 72 consecutive hours by Day 28.|Day 28|||percentage of participants||95% Confidence Interval|Number
733636|NCT00421343|Secondary|Reasons for Non-willingness to Particiapte and Non-adherence With Intervention|We asked participants who would not participate the primary reason for non-particiaption. We also asked participants who were not adherent with recommendations what the primary reason ws for non-adherence.|6 months||||||
733637|NCT00421343|Primary|Number Adherent With the Intervention||6 months|||participants|||Number
733640|NCT00421408|Primary|Anterior-posterior Spine Bone Mineral Density Measured by Dual Energy X-ray Absorptiometry (DXA) at 18 Months|There is no absolute normative range for bone mineral density. Population norms have been established for specific races and men and women for the hip based on data collected by National Health Examination Nutrition Surveys (NHANES) and for the spine based largely on data collected by individual manufacturers. Values within 1 standard deviation of the population mean are generally considered normal. Values below 1 standard deviation from the population mean are generally considered to reflect reduced bone mass.|Measured at 18 months|All participants were analyzed using the mixed models method.||g/cm^2||Standard Error|Least Squares Mean
733641|NCT00421408|Primary|Anterior-posterior Spine Bone Mineral Density Measured by Dual Energy X-ray Absorptiometry (DXA) at 9 Months|There is no absolute normative range for bone mineral density. Population norms have been established for specific races and men and women for the hip based on data collected by National Health Examination Nutrition Surveys (NHANES) and for the spine based largely on data collected by individual manufacturers. Values within 1 standard deviation of the population mean are generally considered normal. Values below 1 standard deviation from the population mean are generally considered to reflect reduced bone mass.|Measured at 9 months|All participants were analyzed using the mixed models method.||g/cm^2||Standard Error|Least Squares Mean
733642|NCT00421408|Primary|Anterior-posterior Spine Bone Mineral Density Measured by Dual Energy X-ray Absorptiometry (DXA) at Baseline|There is no absolute normative range for bone mineral density. Population norms have been established for specific races and men and women for the hip based on data collected by National Health Examination Nutrition Surveys (NHANES) and for the spine based largely on data collected by individual manufacturers. Values within 1 standard deviation of the population mean are generally considered normal. Values below 1 standard deviation from the population mean are generally considered to reflect reduced bone mass.|Measured at 0 months|All participants were analyzed using the mixed models method.||g/cm^2||Standard Error|Least Squares Mean
733643|NCT00421408|Primary|Change in Spine Bone Mineral Density Measured by Quantitative Computed Tomography (QCT) Compared to Baseline|There is no normative data for quantitative computed tomography it is based on local experience.|Measured at baseline and 18 months|Only participants with data at the baseline and 18 month timeframe were used in the analysis. Only half of the study partipants were randomized to receive Quantitative Computed Tomography testing.||percent change||Standard Error|Mean
733644|NCT00421408|Primary|Change in Anterior-posterior Spine Bone Mass Density Measured by Dual Energy X-ray Absorptiometry (DXA) Compared to Baseline|There is no absolute normative range for bone mineral density. Population norms have been established for specific races and men and women for the hip based on data collected by National Health Examination Nutrition Surveys (NHANES) and for the spine based largely on data collected by individual manufacturers. Values within 1 standard deviation of the population mean are generally considered normal. Values below 1 standard deviation from the population mean are generally considered to reflect reduced bone mass.|Measured at baseline and 18 months|Only participants with data at the baseline and 18 month timeframe were used in the analysis.||percentage change||Standard Error|Mean
733645|NCT00421603|Primary|Pattern of Cocaine Use as Measured by the TimeLine Followback||recorded daily for the 14 weeks of the trial or length of participation||||||
733646|NCT00421603|Primary|Three Weeks of Continuous Cocaine Abstinence as Measured by Urine Toxicology and Self Report|Cocaine use was assessed by using urine toxicology confirmed self-report. Self-reported cocaine use data was collected for each day of the study period. Urine samples were collected three times per week. A week was considered abstinence if no cocaine use was self reported during that week and if all urine samples collected that week were negative for cocaine. If a patient achieved three continuous weeks of abstinence based on this criteria they were considered cocaine abstinent in terms of this outcome measure.|3 weeks of abstinence during 14 weeks of trial or for length of participation|||participants|||Number
733647|NCT00421733|Secondary|Change From Baseline to the Last On-treatment Observation in Intact Parathyroid Hormone (iPTH) Levels.|Change is mean change in picograms of iPTH per milliliter of serum.|Baseline (screening period) through 24 weeks of treatment|Intent-to-treat population, which was all randomized subjects who received at least one dose of study drug. Subjects who did not have both a baseline and a last on-treatment measurement were excluded from the analyses.||picogram/milliliter||Standard Deviation|Mean
733648|NCT00421733|Secondary|Change From Baseline to the Last On-treatment Measurement in Albumin Levels Determined From 24-hour Urine Collection.|The change is mean change from baseline to the last on-treatment value, with the data being log transformed prior to analysis. Albumin values were determined from 24-hour urine collections from the baseline and last on-treatment visits.|Baseline (within 1 week prior to first treatment) through 24 weeks of treatment|Intent-to-treat population, which was all randomized subjects who received at least one dose of study drug. Subjects who did not have both a baseline measurement and a last on-treatment visit value were excluded from the analyses.||log milligrams of albumin per 24 hours||Standard Deviation|Mean
733649|NCT00421733|Secondary|Number of Participants Achieving a 15% or Greater Reduction From Baseline to Last On-treatment Urine Albumin to Creatinine Ratio (UACR) Levels.|Number of participants whose last on-treatment albumin to creatinine ratio (UACR) value was reduced at least 15% from the baseline value. Albumin values were determined from 24-hour urine collections from the baseline and last on-treatment visits.|Baseline (within 1 week prior to first treatment) through 24 weeks of treatment|Intent-to-treat population, which was all randomized subjects who received at least one dose of study drug. Subjects who did not have both a baseline measurement and a last on-treatment visit value were excluded from the analyses.||Participants|||Number
733666|NCT00421928|Secondary|Change From Baseline in Western Ontario McMaster Questionnaire (WOMAC) Assessing Pain, Disability and Joint Stiffness of the Knee Over the Last Week of the Maintenance Period at Week 12|Change from baseline to Week 12 of WOMAC Global Score: WOMAC is measure with a Likert ordinal scale from 0-4 with lower scores indicating lower levels of symptoms or physical disability|Baseline and 12 week endpoint|Intent To Treat (ITT), observed cases analysis conducted, no imputation performed.||Scores on a scale||Standard Deviation|Mean
733650|NCT00421733|Primary|Change From Baseline to the Last On-treatment Measurement in Urine Albumin to Creatinine Ratio (UACR) Levels Determined From the First Morning Void (FMV) Urine Collections Comparing Placebo to the Combined Paricalcitol Treatment Groups (1 Mcg and 2 Mcg).|UACR is defined as the ratio: milligram of albumin per gram of creatinine. Baseline UACR was determined as the mean of the 3 UACR measurements from FMV urine collections obtained within 1 week prior to the day of the first dose of study drug. The last on-treatment measurement was the mean of the 3 UACR measurements obtained from FMV urine collections obtained within 1 week of the final week of treatment. The UACR data were log transformed prior to analysis.|Baseline (within 1 week prior to first treatment) through 24 weeks of treatment|Intent-to-treat population, which was all randomized participants who received at least 1 dose of study drug. Subjects without both a baseline and last on-treatment measurement were excluded from the primary efficacy analysis. As such, sample size was N=88 for placebo, N=92 for 1 mcg and for 2 mcg paricalcitol, and N=184 for combined paricalcitol.||log milligram/gram creatinine||Standard Deviation|Mean
733651|NCT00421889|Primary|Dose Limiting Toxicities (DLT), Part A|To determine the number of participants experiencing dose limiting toxicities of belinostat (PXD101) in doses up to 1000 mg/m²/day administered in combination with standard doses of carboplatin and paclitaxel or both.|Cycle 1|||participants|||Number
733652|NCT00421889|Secondary|Belinostat AUC (0-infinity)||Cycle 1 Day 1: Cycle 1 day 1: Pre-Infusion, 0 min, 5 min, 15 min, 30 min, 1 h, 2 h, 3 h, 3 h 15 min, 3 h 30 min, 4 h, 5 h, 6 h, 6 h 15 min, 6 h 30 min, 7h, 8h, 9h, 24h|The Pharmacokinetic Analysis Subset consisted of 39 patients who enrolled in the study and provided a complete or partial set of pharmacokinetic parameters.||ng*h/mL||Standard Deviation|Mean
733653|NCT00421889|Secondary|Belinostat Mean t½||Cycle 1 Day 1: Cycle 1 day 1: Pre-Infusion, 0 min, 5 min, 15 min, 30 min, 1 h, 2 h, 3 h, 3 h 15 min, 3 h 30 min, 4 h, 5 h, 6 h, 6 h 15 min, 6 h 30 min, 7h, 8h, 9h, 24h|The Pharmacokinetic Analysis Subset consisted of 39 patients who enrolled in the study and provided a complete or partial set of pharmacokinetic parameters||hours||Standard Deviation|Mean
733654|NCT00421889|Secondary|Belinostat Cmax||Cycle 1 day 1: Pre-Infusion, 0 min, 5 min, 15 min, 30 min, 1 h, 2 h, 3 h, 3 h 15 min, 3 h 30 min, 4 h, 5 h, 6 h, 6 h 15 min, 6 h 30 min, 7h, 8h, 9h, 24h|The Pharmacokinetic Analysis Subset consisted of 41 patients who enrolled in the study and provided a complete or partial set of pharmacokinetic parameters.||ng/mL||Standard Deviation|Mean
733655|NCT00421889|Secondary|Duration of Response|Defined as interval from the time criteria for CR or PR are met, until the first date that recurrent or progressive disease is objectively documented.|Throughout study|Includes patients with response, i.e. 15 patients in Part B, 0 patients in Part C, and 4 patients in Part D. Not done for Part A.||days||Full Range|Median
733656|NCT00421889|Secondary|Time to Response|Time to response (RECIST) was assessed as the interval between the first dates of treatment until the first notation of response.|Throughout study|Includes patients with response, i.e. 15 patients in Part B, 0 patients in Part C, and 4 patients in Part D. Not done for Part A.||days||Full Range|Median
733657|NCT00421889|Secondary|Time to Progression|Time to progression, defined as the interval between the first dates of treatment until the first notation of disease progression. RECIST criteria|Throughout study|Per protocol Population, includes all patients who have received at least two cycles (complete treatment days, dose reductions per protocol allowed) of study treatment and who have also had at least one post-baseline tumor assessment. Not done for Part A.||days||95% Confidence Interval|Median
733658|NCT00421889|Secondary|To Determine the Pharmacodynamic Effects of Belinostat (in the Combination) on Histone Acetylation in Peripheral Blood Mononuclear Cells (Selected Sites)||Throughout the study|Histone acetylase analysis was planned, but not successful due to technical issues with the method.|||||
733659|NCT00421889|Secondary|Best Overall Response (CR or PR)|Best overall responses were assessed by RECIST (Response Evaluation Criteria in Solid Tumors) criteria. Clinical tumor evaluation will take place after each cycle. Formal radiological evaluation after every 2 cycles. If a response is noted, a follow-up radiographic assessment must be performed 4 weeks (+ 1 week) after the response is noted|Throughout study until PD (progressive disease) or lost to follow up|Primary efficacy analysis population, includes all patients who have been enrolled into the study and received at least one dose of study medication.||participants|||Number
733660|NCT00421889|Primary|Maximum Tolerable Dose (MTD) Belinostat, Part A,|To determine the maximum tolerated dose of belinostat (PXD101) in doses up to 1000 mg/m²/day administered in combination with standard doses of carboplatin (AUC of 5) and paclitaxel (175 mg/m2).|Cycle 1|||mg/m2|||Number
733661|NCT00421928|Secondary|Change From Baseline in Responder Analysis 50% Improvement to Week 12|"Defined by the percentage of subjects achieving at least 50% improvement from baseline in the primary endpoint based on the 11-point NRS at week 12. For this twice daily pain assessment, the subjects were to indicate the level of pain experienced over the previous 12 hours on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Baseline and Week 12|ITT. Subjects who discontinued from the study were considered non-responders.||Percentage of participants|||Number
733662|NCT00421928|Secondary|Change From Baseline in EuroQol-5 (EQ-5D) Health Status Index to Week 12|"Change from baseline to end point in EuroQol-5 (EQ-5D) Dimension Questionnaire. A higher score indicates an improvement in health in the Health Status Index. The EQ-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating full health and 0 representing dead"|Baseline and 12 week endpoint|ITT||scores on a scale||Standard Deviation|Mean
733663|NCT00421928|Secondary|Distribution of Time to Treatment Discontinuation Due to Lack of Efficacy|The median time to treatment discontinuation due to lack of efficacy from baseline to endpoint|Baseline to 12 weeks|ITT: The results for median and interquartile ranges were not estimable because insufficient number of subjects discontinued due to lack of efficacy to estimate the values.||median time|||Number
733664|NCT00421928|Secondary|Percentage of Patients Who Reported Very Much Improved or Much Improved From Baseline in Patient Global Impression of Change Over the Last Week of the Maintenance Period at Week 12|Ordinal measure indicating change from start of treatment (on a scale of 7 = Very much worse to 1 = Very much improved)|Baseline and 12 week endpoint|ITT||percentage of participants|||Number
733667|NCT00421928|Primary|Change From Baseline of the Average Pain Intensity Based on an 11-point Numerical Rating Scale(NRS) Over the Last Week of the Maintenance Period at Week 12.|"For this twice daily pain assessment, the subjects were to indicate the level of pain experienced over the previous 12 hours on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Baseline and 12 weeks (Primary endpoint is the average pain intensity score during the last week of the maintenance period).|Intent-to-treat (ITT) population. Last observation carried forward (LOCF) was used to impute pain score after discontinuation||Scores on a scale||Standard Deviation|Mean
733668|NCT00421954|Primary|Weight Gain and Other Side Effects||couple of months|P.I. has left the institution and NYSPI has no access to the data. Results will not be analyzed or presented.|||||
733669|NCT00421993|Secondary|Percent Change in Total Lesion Counts|Percent Changes in Total Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100|at week 12|ITT, LOCF||Percent change||Standard Deviation|Mean
733670|NCT00421993|Secondary|Percent Change in Noniflammatory Lesion Counts|Percent Changes in Noninflammatory Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100|at week 12|ITT, LOCF||Percent change||Standard Deviation|Mean
733671|NCT00421993|Secondary|Percent Change in Inflammatory Lesion Counts|Percent Changes in Inflammatory Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100|at week 12|ITT, LOCF||Percent change||Standard Deviation|Mean
733672|NCT00421993|Primary|Changes in Noninflammatory Lesion Counts|Change in Noninflammatory Lesion Counts equals Week 12 Noninflammatory Lesion Count minus Baseline Noninflammatory Lesion Count|from Baseline to week 12|ITT, LOCF||Lesion count||Full Range|Median
733673|NCT00421993|Primary|Changes in Inflammatory Lesion Counts|Changes in Inflammatory Lesion Counts equals Week 12 Inflammatory Lesion Counts minus Baseline Inflammatory Lesion Counts|from Baseline to week 12|ITT, LOCF||Lesion count||Full Range|Median
733674|NCT00421993|Primary|Success Rate on the Investigator's Global Assessment|Percentage of subjects rated “Clear” and “Almost Clear” on 5-point scale (0=clear; 4=severe)|at week 12|Intention to treat (ITT), last observation carried forward (LOCF).||Percentage of participants|||Number
733675|NCT00422032|Primary|Number of Participants With Response for Two Dose Schedules of Clofarabine|Response defined as Complete Remission (CR): Normalization of blood counts with neutrophils >/= 1 * 10^9/L and platelet counts >/= 100 * 10^9/L, and marrow blasts </=5%; Partial Remission: as above except for presence of 6-15% marrow blasts, or 50% reduction if <15% at start of treatment; or Hematologic Improvement (HI): Complete Response (CR) with the exception of a lack of platelet recovery to >/= 100 * 10^9/L. Repeat bone marrow samples collected every 1-3 cycles (4-8 week cycle).|4 weeks (minimum 1 cycle) up to 24 weeks (maximum 3 cycles of 8 weeks)|||Participants|||Number
733696|NCT00422097|Secondary|Number of Participants With Abnormal (CTC Grade 3 or Greater) Serum Chemistry Levels|Upper limit of normal (ULN)=upper level of normal among all laboratory ranges. Alkaline phosphatase(U/L): Gr 3: >5.0-20.0*ULN; Gr 4: >20.0*ULN. Sodium (mEq/L): Gr 3: 120-<130 or >155-160; Gr 4 <120. Potassium (mEq/L): Gr 3: 2.5-<3.0 or >6.0-7.0; Gr 4: <2.5 or >7.0. Calcium (mg/dL): Gr 3: 6.0-<7.0 or >12.5-13.5; Gr 4: <6.0 or >13.5. Inorganic phosphorus (mg/dL): Gr 3: 1.0-<2.0; Gr 4: <1.0. Albumin (g/dL): Gr 3: <2.0.|At screening and predose Day 1, Cycle 1 (21 days)|All Treated Subjects: All subjects who received at least one dose of ixabepilone were included.||Participants|||Number
733697|NCT00422097|Secondary|Number of Participants With Significant Findings on Physical Examination or Electrocardiogram (ECG)|Physical examination evaluated height, weight, Eastern Cooperative Oncology Group performance status, adverse events, and abnormal laboratory findings and included a neurologic examination to evaluate deep tendon reflexes, sensory modalities, and motor strength. Participants also underwent a 12-lead ECG screening. Physical examination findings and ECG findings were considered clinically significant at the investigator's discretion.|At screening and predose Day 1, Cycle 1 (21 days)|Although physical examinations and ECGs were performed, the findings were not summarized.||Participants|||Number
733698|NCT00422097|Secondary|Area Under the Curve in 1 Dosing Interval (AUC[TAU]) of Oral Ixabepilone With and Without Famotidine in Crossover Cohorts|After the ixabepilone MTD (25 mg) has been defined, participants who completed Cycle 1 (ixabepilone, 25 mg, given alone once daily orally on Days 1 through 5 of 21-day cycle, with participants fasting at least 4 hours before and 4 hours after treatment on all dosing days) then cross over to Cycle 2, during which they receive famotidine, 40 mg. Prior to dosing on Day 1 of Cycle 2, famotidine administered in an oral dose 2 hours before ixabepilone 25-mg dose.|Up to 24 hours postdose Day 1 of Cycle 1 (21 days) and Day 1 of Cycle 2 (21 days)|Participants who received ixabepilone, at the MTD of 25 mg, alone in Cycle 1 and had adequate concentration profiles. Participants then were crossed over to a cycle in which they received MTD (25 mg) ixabepilone with famotidine,40 mg, on Day 1 of Cycle 2.||ng*h/mL||Standard Deviation|Mean
733699|NCT00422097|Secondary|Time of Maximum Plasma Concentration (Tmax) of Oral Ixabepilone With and Without Famotidine in Crossover Cohorts|After the ixabepilone MTD (25 mg) has been defined, participants who completed Cycle 1 (ixabepilone, 25 mg, given once daily orally on Days 1 through 5 of 21-day cycle, with participants fasting at least 4 hours before and 4 hours after treatment on all dosing days) then cross over to Cycle 2, during which they receive famotidine, 40 mg. Prior to dosing on Day 1 of Cycle 2, famotidine administered in an oral dose 2 hours before ixabepilone 25-mg dose.|Up to 24 hours postdose Day 1 of Cycle 1 (21 days) and Day 1 of Cycle 2 (21 days)|Participants who received ixabepilone, at the MTD of 25 mg, alone in Cycle 1 and had adequate concentration profiles. Participants then were crossed over to a cycle in which they received MTD (25 mg) ixabepilone with famotidine,40 mg, on Day 1 of Cycle 2.||ng/mL||Full Range|Median
733700|NCT00422097|Secondary|Maximum Plasma Concentration (Cmax) of Oral Ixabepilone With and Without Famotidine in Crossover Cohorts|After the ixabepilone MTD (25 mg) has been defined, participants who completed Cycle 1 (ixabepilone, 25 mg, given once daily orally on Days 1 through 5 of 21-day cycle, with participants fasting at least 4 hours before and 4 hours after treatment on all dosing days) then cross over to Cycle 2, during which they receive famotidine, 40 mg. Prior to dosing on Day 1 of Cycle 2, famotidine administered in an oral dose 2 hours before ixabepilone 25-mg dose.|Up to 24 hours postdose Day 1 of Cycle 1 (21 days) and Day 1 of Cycle 2 (21 days)|Participants who received ixabepilone, at the MTD of 25 mg, alone in Cycle 1 and had adequate concentration profiles. Participants then were crossed over to a cycle in which they received MTD (25 mg) ixabepilone with famotidine,40 mg, on Day 1 of Cycle 2.||ng/mL||Standard Deviation|Mean
733701|NCT00422097|Secondary|Area Under the Curve in 1 Dosing Interval (AUC[TAU]) of Oral Ixabepilone at MTD in Fasted and Fed Participants in Crossover Cohorts|After the ixabepilone MTD (25 mg) has been defined, participants who completed Cycle 1 (ixabepilone, 25 mg, given once daily orally on Days 1 through 5 of 21-day cycle, with participants fasting at least 4 hours before and 4 hours after treatment on all dosing days) then cross over to Cycle 2, during which they consume a standard lowfat meal starting 30 minutes prior to ixabepilone, 25 mg, administration on Day 1 of Cycle 2 only. Meal is consumed within a 30-minute period. Administration of the total oral dose should not exceed more than 10 minutes from start to finish.|Up to 24 hours postdose Day 1 of Cycle 1 (21 days) and Day 1 of Cycle 2 (21 days)|All participants who received ixabepilone and who had adequate concentration profiles. Participants received MTD (25 mg).||ng*h/mL||Standard Deviation|Mean
733702|NCT00422097|Secondary|Time of Maximum Plasma Concentration (Tmax)of Oral Ixabepilone at MTD in Fasted and Fed Participants in Crossover Cohorts|After the ixabepilone MTD (25 mg) has been defined, participants who completed Cycle 1 (ixabepilone, 25 mg, given once daily orally on Days 1 through 5 of 21-day cycle, with participants fasting at least 4 hours before and 4 hours after treatment on all dosing days) then cross over to Cycle 2, during which they consume a standard lowfat meal starting 30 minutes prior to ixabepilone, 25 mg, administration on Day 1 of Cycle 2 only. Meal is consumed within a 30-minute period. Administration of the total oral dose should not exceed more than 10 minutes from start to finish.|Up to 24 hours postdose Day 1 of Cycle 1 (21 days) and Day 1 of Cycle 2 (21 days)|All participants who received ixabepilone and who had adequate concentration profiles. Participants received MTD (25 mg).||ng/mL||Full Range|Median
733703|NCT00422097|Secondary|Maximum Plasma Concentration (Cmax) of Oral Ixabepilone at MTD in Fasted and Fed Participants in Crossover Cohorts|After the MTD has been defined, participants who completed Cycle 1 (ixabepilone, 25 mg, given once daily orally on Days 1 through 5 of 21-day cycle, with participants fasting at least 4 hours before and 4 hours after treatment on all dosing days) then cross over to Cycle 2, during which they consume a standard lowfat meal starting 30 minutes prior to ixabepilone, 25 mg, administration on Day 1 of Cycle 2 only. Meal is consumed within a 30-minute period. Administration of the total oral dose should not exceed more than 10 minutes from start to finish.|Up to 24 hours postdose Day 1 of Cycle 1 (21 days) and Day 1 of Cycle 2 (21 days)|All participants who received ixabepilone and who had adequate concentration profiles. Participants received MTD (25 mg) ixabepilone without famotidine (Cycle 1) and then were crossed over to a cycle in which they received MTD (25 mg) ixabepilone with famotidine (Cycle 2).||ng/mL||Standard Deviation|Mean
733704|NCT00422097|Secondary|Plasma Half-life (T-Half) of Ixabepilone||Day 5 of Cycle 1|All participants who received ixabepilone and who had adequate concentration profiles||Hours||Standard Deviation|Mean
733756|NCT00422383|Secondary|Change From BL in Anti-CCP Antibody Titers in U/mL||Weeks 8, 24, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint.||U/mL||Standard Deviation|Mean
733708|NCT00422097|Primary|Number of Participants With DLTs by Worst Common Terminology Criteria (CTC) Grade|Adverse events (AEs) graded by CTC version 3. Grade (Gr) 1=mild; Gr 2=moderate; Gr 3=severe; Gr 4=life threatening; Gr 5=Death related to AE. DLT is defined as an event related to ixabepilone that occurs during the first course of treatment. Includes neutropenia; thrombocytopenia; Gr 3 or 4 nausea, vomiting, or diarrhea despite adequate medical intervention and prophylaxis; Gr 3 fatigue or asthenia; transient arthralgia or myalgia unresponsive to medical intervention; any Gr 3 nonhematologic toxicity; and prolonged recovery from a toxicity.|Days 1 through 21 (Cycle 1), continuously|All Treated Participants: All participants who received at least one dose of ixabepilone were included.||Participants|||Number
733709|NCT00422097|Secondary|Number of Participants With Abnormal Laboratory Values by Worst CTC Grade|Lower limit of normal (LLN)=lowest level of normal among all laboratory ranges. Hemoglobin (g/dL): Gr 1: 10.0-<LLN; Gr 2: 8.0-<10.0; Gr 3:6.5-<8.0; Gr 4: 6.5. Leukocytes (c/uL): Gr 1: 3.0-<LLN; Gr 2: 2.0-<3.0; Gr 3: 1.0-<2.0; Gr 4: <1.0. Lymphocytes (c/uL): Gr 1: 0.8-<1.5; Gr 2: 0.5-<0.8; Gr 3: 0.2-<0.5; Gr 4: <0.2. Neutrophils (Absolute)(c/uL): Gr 1: 1.5-<2.0; Gr 2: 1.0-<1.5; Gr 3: 0.5-<1.0; Gr 4: <0.5. Neutrophils + Bands (c/uL): Gr 1: 1.5-<2.0; Gr 2: 1.0-<1.5; Gr 3: 0.5-<1.0; Gr 4: <0.5. Platelet Count (c/uL):Gr 1: 75.0-<LLN; Gr 2: 50.0-<75.0; Gr 3: 25.0-<50.0; Gr 4: <25.0.|Baseline and Days 1, 8, and 15 of Cycle 1 (21 days)|All Treated Subjects: All subjects who received at least one dose of ixabepilone were included.||Participants|||Number
733710|NCT00422097|Primary|Maximum Tolerated Dose (MTD) of Ixabepilone|MTD is based on Cycle 1 data only and defined as the maximum dose that can be administered to 6 participants with no more than 1 experiencing a dose-limiting toxicity (DLT) (or fewer than one third of participants if more than 6 receive treatment) with at least 2 participants experiencing a DLT at the next higher dose level. DLT=an event, such as neutropenia; thrombocytopenia; Gr 3 or 4 nausea or diarrhea; Gr 3 fatigue or asthenia; transient arthralgia or recalcitrant myalgia; and prolonged recovery from a toxicity, that occurs during the first course of treatment.|Days 1 through 21 (Cycle 1)|All Treated Subjects: All subjects who received at least one dose of ixabepilone were included.||mg/d|||Number
733711|NCT00422097|Secondary|Number of Participants With Death as Outcome, Treatment-related Adverse Events (AEs), and AEs Leading to Discontinuation|An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with treatment. Treatment related=possibly, probably, or certainly related to and of unknown relationship to study treatment.|Days 1 through 21 (Cycle 1), continuously|All Treated Subjects: All subjects who received at least 1 dose of ixabepilone.||Participants|||Number
733712|NCT00422162|Secondary|Change From Baseline to Week 4 and Week 8 in Weight|Change in weight = Post-baseline visit minus baseline.|Baseline to Weeks 4 and 8|All randomized participants with at least one dose of study drug and a baseline and at least one post-baseline value. Last observation carried forward.||kilograms||Standard Deviation|Mean
733713|NCT00422162|Secondary|Number of Participants Experiencing High Values for Vital Signs at Any Time During the Study|Systolic and diastolic blood pressure and pulse rate were measured after 2 minutes rest in a supine position. High values were: diastolic blood pressure ≥90 mm Hg and increase from baseline of ≥10 mm Hg; systolic blood pressure ≥140 mm Hg and increase from baseline of ≥10 mm Hg; pulse rate ≥100 beats per minute (bpm) and an increase of ≥10 bpm from baseline.|over 8 weeks|All randomized participants with at least one dose of study drug.||participants|||Number
733714|NCT00422162|Secondary|Discontinuations Due to Adverse Events (AE)|Listing of adverse events (AE) that led to treatment discontinuation (DC).|over 8 weeks|All randomized participants with at least one dose of study drug.||participants|||Number
733715|NCT00422162|Secondary|Number of Patients With Potentially Clinically Significant Laboratory Findings|Laboratory results that were potentially clinically significant.|over 8 weeks|All randomized participants with at least one dose of study drug.||participants|||Number
733716|NCT00422162|Secondary|Utilization of Allowed Hypnotic and/or Anxiolytic Co-Medication|Number of participants using medication for anxiety and sleep disturbances.|over 8 weeks|All randomized participants who received at least one dose of study drug; had baseline and at least one post-baseline value. Last observation carried forward. The total number of patients with hypnotics and anxiolytics concomitant therapies was 125 (Duloxetine 60mg) and 123 (Duloxetine 120mg).||participants|||Number
733717|NCT00422162|Secondary|Reason for Living (RFL) Questionnaire Mean Scores at Baseline and Week 8|"The RFL questionnaire is an instrument that evaluates patient's reasons for not committing suicide using a 6-point rating scale, where 1 is not at all important and 6 is extremely important. The questionnaire required participants to rate how important each item would be for living, if suicide was contemplated. Mean scores could range from 0 to 6."|Baseline and Week 8|All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline value. Last observation carried forward. Participants were assigned their responder status at Week 4 and the data were retrospectively divided into these groups.||units on a scale||Standard Deviation|Mean
733718|NCT00422162|Secondary|Patients Reaching Remission|Major Depressive Disorder remission was defined as a total MADRS score ≤12 at Week 8.|Week 8|All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline value. Last observation carried forward. Participants were assigned their responder status at Week 4 and the data were retrospectively divided into these groups.||participants|||Number
733719|NCT00422162|Secondary|Percentage of Responders|Patients with reduction in MADRS score ≥50% after 4 weeks were to stay on previous dose of duloxetine. Those with reduction in MADRS <50% were to receive 120 mg for remaining 4 weeks of treatment (up-titration from 60 mg to 120 mg for those randomized to 60 mg, and addition of placebo to 120 mg dose for those randomized to 120 mg). However, 2/70 patients randomized to 60 mg and then up-titrated to 120 mg after 4 weeks had reduction in MADRS ≥50% after 4 weeks, and 3/64 patients randomized to 120 mg and then given placebo in addition after 4 weeks had reduction in MADRS ≥50% after 4 weeks.|4 to 8 weeks|All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline value. Last observation carried forward. Participants were assigned their responder status at Week 4 and the data were retrospectively divided into these groups.||percentage of participants|||Number
733757|NCT00422383|Secondary|Anti-Cyclic Citrullinated Peptide (CCP) Antibody Titers at BL in Units Per mL (U/mL)||BL|SAP. 3, 3, and 2 participants were not analyzed for this outcome measure from the Low Dose, Escalated Dose, and High Dose, groups, respectively.||U/mL||Standard Deviation|Mean
733720|NCT00422162|Secondary|Hamilton Anxiety Scale (HAMA) Score at Baseline and Weeks 4 and 8|The HAMA scale measures anxiety symptoms accompanying Major Depressive Disorder (MDD). Each item of the 14-item HAMA was scored from 0 (not present) to 4 (very severe), with a resulting maximum total score of 56.|Baseline and Weeks 4 and 8|All randomized participants who received at least one dose of study drug; had baseline and at least one post-baseline value. Last observation carried forward.||units on a scale||Standard Deviation|Mean
733721|NCT00422162|Secondary|Patient Global Impression of Improvement (PGI-I) Score at Each Visit|A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).|Weeks 1, 2, 3, 4, 6, 8|All randomized participants who received at least one dose of study drug; had baseline and at least one post-baseline value. Last observation carried forward.||units on a scale||Standard Deviation|Mean
733722|NCT00422162|Secondary|Clinical Global Impression of Improvement (CGI-I) at Each Visit|Measures clinician's perception of patient improvement at the time of assessment compared with the start of treatment. Scores range from 1 (very much better) to 7 (very much worse).|Weeks 1, 2, 3, 4, 6, 8|All randomized participants who received at least one dose of study drug; had baseline and at least one post-baseline value. Last observation carried forward.||units on a scale||Standard Deviation|Mean
733723|NCT00422162|Secondary|Clinical Global Impression of Severity (CGI-S) Scores at Each Visit|Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Baseline, Weeks 1, 2, 3, 4, 6, 8|All randomized participants who received at least one dose of study drug; had baseline and at least one post-baseline value. Last observation carried forward.||units on a scale||Standard Deviation|Mean
733724|NCT00422162|Secondary|Evaluation of Rescue Options Based on Changes in the Montgomery-Asberg Depression Rating Scale (MADRS) and the 6-Item Hamilton Depression Scale (HAMD-6)|"Changes in Montgomery-Åsberg Depression Rating Scale (MADRS) and 6-Item Hamilton Depression Scale (HAMD-6) total scores were evaluated following dose up-titration in those patients who did not achieve the minimum 50% response for primary endpoint. MADRS is a rating scale for severity of depressive mood symptoms. Total scores range from 0 (low severity of symptoms) to 60 (high severity of symptoms). The HAMD-6, derived by the sum of HAMD-17 items 1, 2, 7, 8, 10 and 13, evaluates core symptoms of Major Depressive Disorder (MDD). Total subscale scores range from 0 (normal) to 22 (severe)."|4 to 8 weeks|All randomized participants who received at least one dose of study drug and had a Week 4 and at least one following value. Last observation carried forward. Participants were assigned their responder status at Week 4 and the data were retrospectively divided into these groups.||units on a scale||Standard Deviation|Mean
733725|NCT00422162|Secondary|Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score From Baseline|Measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline to Weeks 1, 2, 3, 4, 6, 8|All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline value. Last observation carried forward. Participants were assigned their responder status at Week 4 and the data were retrospectively divided into these groups.||units on a scale||Standard Deviation|Mean
733726|NCT00422162|Secondary|Change in 6-Item Hamilton Depression Scale (HAMD-6) Total Scores From Baseline|"The HAMD-6 (Items 1,2,7,8,10,13 from the 17-item HAMD) evaluates core symptoms of Major Depressive Disorder (MDD). Total scores range from 0 (normal) to 22 (severe)."|Baseline to Weeks 1, 2, 3, 4, 6, 8|All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline value. Last observation carried forward. Participants were assigned their responder status at Week 4 and the data were retrospectively divided into these groups.||units on a scale||Standard Deviation|Mean
733727|NCT00422162|Primary|Change From Baseline to 4 Week Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|Measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline to Week 4|All randomized participants who received at least one dose of study drug; had baseline and at least one post-baseline value. Last observation carried forward.||units on a scale||Standard Deviation|Mean
733728|NCT00422201|Secondary|Features of Cushing's Syndrome||8 weeks at steady dose||||||
733729|NCT00422201|Primary|Glycemic Disorders Improved or Normalized|"Criteria for improvement or normalization of glycemic disorders:
A. For diabetic patients (known or diagnosed at pre-inclusion visit)
Decrease in HbA1c > 0.3% B. For patients with IGT
Normalization of OGTT (2-hour glucose plasma level after 75 g OGTT < 7.8 mmol/L (140 mg/dL) D. For patients with IFG
If impaired fasting glucose is also associated with impaired glucose tolerance during OGTT at pre-inclusion:
- Normalization of OGTT (2-hour glucose plasma level after 75 g OGTT < 7.8 mmol/L (140 mg/dL)
If impaired fasting glycemia is associated with normal OGTT at pre-inclusion (except at T0):
- Normalization of fasting plasma glucose (fasting plasma glucose < 5.5 mmol/L (100 mg/dL)"|8 weeks at steady dose|18 patients were recruited. 7 completed the study but only 3 according to the last protocol version (in which primary efficacy criteria were changed), so only these 3 patients were to be analysed||participants|||Number
733730|NCT00422227|Secondary|Percent Change From Baseline in General Health, Pain, and Fatigue, Visual Analog Scales|VAS, participant indicates by marking a vertical line at an appropriate position through a horizontal line. The length of the line measures from left (in mm) and the value (in mm) is recorded. General Health VAS, “in general how would you rate your heath over the last 2-3 weeks”, 0mm equals very well and 100mm equals extremely bad. Pain VAS: “indicate the amount of pain experienced during the last 2-3 days”, 0 mm equals no pain and 100 mm equals pain as bad as it can be. Fatigue VAS: “how fatigued or tired have you been over the last week”, range =No Fatigue - Extremely Fatigued.|Week 2, 4, 8, 12, 16|The mITT population, defined as all randomly assigned subjects who received at least 1 dose of ETN or MTX in the ETN group or 1 dose of usual DMARD therapy medication or MTX in the usual DMARD therapy group and had at least 1 postbaseline assessment.||Percent change|||Number
733759|NCT00422383|Secondary|Percentage of Participants With Total Immunoglobin (Ig), IgA, IgG, and IgM Results Below the LLN|The LLNs for total Ig, IgA, IgG, and IgM were defined as 6.75 grams per liter (g/L), 0.70 g/L, 65 g/L, and 0.40 g/L, respectively.|BL, Weeks 24 and 48|ITT-M2 population, n=number of participants assessed for the given parameter at the specified timepoint.||percentage of participants|||Number
733731|NCT00422227|Secondary|Percent Change From Baseline in Duration (Minutes) of Morning Stiffness|The duration of morning stiffness on the day of examination should be determined by asking the following two questions: When did you awaken this morning? When were you able to resume your normal activities without stiffness? Duration of morning stiffness is equal to the time elapsed between the above two times in minutes; If none is present enter 0, If morning stiffness is still continuing, please indicate average of duration of stiffness over the past 3 days. If stiffness persists the entire day 1440 minutes (24h x 60 minutes) should be recorded.|Week 2, 4, 8, 12, 16|The mITT population, defined as all randomly assigned subjects who received at least 1 dose of ETN or MTX in the ETN group or 1 dose of usual DMARD therapy medication or MTX in the usual DMARD therapy group and had at least 1 postbaseline assessment.||Percent change|||Number
733732|NCT00422227|Secondary|Percent Change From Baseline in Physician And Subject Global Assessments|The Physician Global Assessment of Disease Activity: The participant's disease activity is estimated over the last two - three days by the physician; A zero (0) means no disease activity and a ten (10) means extreme disease activity. The Subject Global Assessment of Disease Activity: The participant assesses overall arthritis activity. A zero (0) means no disease activity and a ten (10) means extreme disease activity.|Week 2, 4, 8, 12, 16|The mITT population, defined as all randomly assigned subjects who received at least 1 dose of ETN or MTX in the ETN group or 1 dose of usual DMARD therapy medication or MTX in the usual DMARD therapy group and had at least 1 postbaseline assessment.||Percent change|||Number
733733|NCT00422227|Secondary|Percent Change From Baseline in Painful and Swollen Joint Counts|Participant's assessment of pain - A horizontal pain visual analog scale (VAS) (0-100 mm) is used to assess the participants current level of pain; 0 = no pain and 100 = worst pain. Swollen joint count - ACR swollen joint count, an assessment of 28 joints. Joints are classified as either swollen or not swollen.|Week 2, 4, 8, 12, 16|The mITT population, defined as all randomly assigned subjects who received at least 1 dose of ETN or MTX in the ETN group or 1 dose of usual DMARD therapy medication or MTX in the usual DMARD therapy group and had at least 1 postbaseline assessment.||Percent change|||Number
733734|NCT00422227|Secondary|Percentage of Participants With DAS28 Improvement of ≥0.6 and ≥1.2|Disease Activity Score 28 based on 28 Joints (DAS28) is the calculation of DAS28: DAS28 = 0.56 sqrt (28 painful joint count) + 0.28 sqrt (28 swollen joint count) + 0.70 (ln erythrocyte sedimentation rate (ESR) + 0.014 (General Health) (GH). GH = Subject general health visual analog scale (0–10 mm).|Week 16|The mITT population, defined as all randomly assigned subjects who received at least 1 dose of ETN or MTX in the ETN group or 1 dose of usual DMARD therapy medication or MTX in the usual DMARD therapy group and had at least 1 postbaseline assessment.||Percentage of Participants|||Number
733735|NCT00422227|Secondary|Percentage of Participants Achieving European League Against Rheumatism (EULAR) Moderate or Good Response|EULAR Response Criteria DAS28) improvement at week 16. Good response was defined as >1.2 improvement in DAS from Baseline and DAS attained during follow-up of ≤2.4. Non-responders were participants with improvement of ≤0.6 or participants with improvement of >0.6 but ≤1.2 and DAS attained during follow-up of >3.7. Remaining participants were classified as moderate. Scores of good and moderate were considered to have therapeutic response.|Week 16|The mITT population, defined as all randomly assigned subjects who received at least 1 dose of ETN or MTX in the ETN group or 1 dose of usual DMARD therapy medication or MTX in the usual DMARD therapy group and had at least 1 postbaseline assessment.||Percentage of Participants|||Number
733736|NCT00422227|Secondary|Percent Change From Baseline in DAS28 at Week 16|Disease Activity Score 28 based on 28 Joints (DAS28) is the calculation of DAS28: DAS28 = 0.56 sqrt (28 painful joint count) + 0.28 sqrt (28 swollen joint count) + 0.70 (ln erythrocyte sedimentation rate (ESR)) + 0.014 (General Health) (GH). GH = Subject general health visual analog scale (0–10 mm).|Week 16|The mITT population, defined as all randomly assigned subjects who received at least 1 dose of ETN or MTX in the ETN group or 1 dose of usual DMARD therapy medication or MTX in the usual DMARD therapy group and had at least 1 postbaseline assessment.||Percent change|||Number
733737|NCT00422227|Secondary|Percentage of Participants Achieving DAS28 <3.2 (Low Disease Activity) and <2.6 (Remission)|Disease Activity Score 28 based on 28 Joints (DAS28) is the calculation of DAS28: DAS28 = 0.56 sqrt (28 painful joint count) + 0.28 sqrt (28 swollen joint count) + 0.70 (ln erythrocyte sedimentation rate (ESR)) + 0.014 (General Health) (GH). GH = Subject general health visual analog scale (0–10 mm).|Week 16|The mITT population, defined as all randomly assigned subjects who received at least 1 dose of ETN or MTX in the ETN group or 1 dose of usual DMARD therapy medication or MTX in the usual DMARD therapy group and had at least 1 postbaseline assessment.||Percentage of Participants|||Number
733738|NCT00422227|Secondary|Percentage of Participants Achieving ACR 20, 50, and 70 Responses|Response includes improvement in tender or swollen joints as well as 20 percent improvement in three of the other five criteria. Required: ≥ 20%, 50% or 70% improvement in tender joint count ≥ 20% , 50% or 70% improvement in swollen joint count and at least 20%, 50%, 70% improvement in 3 of the following 5:Patient pain assessment , Patient global assessment ,Physician global assessment, Patient self-assessed disability.|Week 16|The mITT population, defined as all randomly assigned subjects who received at least 1 dose of ETN or MTX in the ETN group or 1 dose of usual DMARD therapy medication or MTX in the usual DMARD therapy group and had at least 1 postbaseline assessment.||Percentage of Participants|||Number
733739|NCT00422227|Primary|Change From Baseline in Adjusted Mean of American College of Rheumatology Response (ACR-N) Area Under Curve (AUC) Over 16 Weeks|"ACR-N = the lowest of 3 values (percent change in the number of swollen joints, percent change in the number of tender joints, and median of the other 5 measures in the ACR core data set). Negative numbers indicate worsening.
The ACR-N AUC was calculated using the trapezoidal rule as the ACR-N multiplied by the duration of the assessment period (in weeks) and was presented as %-weeks."|16 weeks|The mITT population, defined as all randomly assigned subjects who received at least 1 dose of ETN or MTX in the ETN group or 1 dose of usual DMARD therapy medication or MTX in the usual DMARD therapy group and had at least 1 postbaseline assessment.||Units on a scale||Standard Error|Mean
733758|NCT00422383|Secondary|Percentage of Participants Who Were Rheumatoid Factor (RF) - Seronegative|Percentage of participants who were RF seropositive at BL who became RF seronegative over the course of the study. RF seropositive status was defined as RF ≥ 20 international units (IU) per mL. RF seronegative status was defined as RF < 20 IU/mL.|BL, Weeks 8, 24, and 48|RF seropositive participants from the ITT-M2 population, n=number of participants assessed for the given parameter at the specified timepoint.||percentage of participants|||Number
733740|NCT00422279|Primary|Primary Endpoint Was to Assess Implant Stability of the Implants( 4 Patients in Two Groups With a Total of 8 Implants) at Baseline and After 3 Months of Submerged Healing and After 6 Months of Prosthetic Loading|The following success criteria for the primary endpoint have been adopted and apply to both treatment groups. 1.The implant stability (ISQ) was recorded by means of resonance frequency analysis (RFA) at implant insertion, 3 months and after 6 months of loading 2. radiographic and computed tomography analyses shall not show any signs of peri-implant radiolucency at the 3 and 6 month time point 3. implant stability after 3 months shall allow tightening to 35Ncm without implant rotation by using a torque wrench|Implant insertion, 3 months, 6 months|Implant stability was measured using a torque wrench, Resonance frequency analysis was conducted, radiographs were analyzed and computed tomography was performed||implants|Participants||Number
733741|NCT00422279|Secondary|Number of Participants Showing Bone Growth With rhBMP-2 (15 and 30 µg Per Implant)|"The secondary endpoint of the study was to assess the minimum dose of rhBMP2 eliciting bone growth.The secondary endpoint was assessed by measuring using a probe the quantity of any newly formed bone 1.in the group where implants were placed in the supra alveolar position the treatment is successful if the bone exceeds 1.5 mm above the initial alveolar bone level in all measured points 1. in the group where implants were placed in extraction sockets the treatment is successful if the gap between the implant body and the extraction socket is filled with Bone.
Safety dose used:- In the dog model; seroma formation was extensive with higher rhBMP-2 concentrations (3.0 and 4.0 mg/mL.Seromas was also significant in the dog model for the 0.75 and 1.5 mg/mL rhBMP-2 concentrations, hence a minimum dose of 15 and 30 µg per implants was chosen)"|3 months|1.When implants were placed in the supraalveolar position the treatment was not successful 2. in the group where implants were placed in extraction sockets the treatment was not successful||Number of participants with bone grow|||Number
733742|NCT00422292|Other Pre-specified|Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age||Days 0 to 7 after vaccination|Solicited Injection Site and Systemic Reactions were assessed in the intend-to-treat population.||Percentage of Participants|||Number
733743|NCT00422292|Other Pre-specified|Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age|"Solicited injection site reactions: Injection site tenderness, injection site erythema, and injection site swelling.
Solicited systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, and irritability."|Days 0 to 7 after vaccination|||Percentage of Participants|||Number
733744|NCT00422292|Other Pre-specified|Percentage of Participants With Anti-Pneumococcal Concentrations ≥ 0.35 μg/mL After Pneumococcal Conjugate Vaccine (PCV) in Group 3 and Group 4||Day 30 after 12-month vaccination|||Percentage of Participants|||Number
733745|NCT00422292|Primary|Geometric Mean Concentrations (GMCs) of Anti-Pneumococcal Antibodies After Pneumococcal Conjugated Vaccine (PCV) in Groups 3 and 4||Day 30 after the 12-month vaccination|Geometric Mean Concentrations (GMCs) were determined in the per-protocol population Group 3 and Group 4.||Titers||95% Confidence Interval|Geometric Mean
733746|NCT00422292|Primary|Measles, Mumps, Rubella, and Varicella (MMRV) Antibody Values in Participants Who Received MMRV Vaccine (Groups 2 and 4 Only)|Percentage of participants who had a concentration of ≥ 300 mIU/mL in the enzyme-linked immunosorbent assay (ELISA) or ≥ 120 mIU/mL in the neutralization when the ELISA concentration was less than 300 mIU/mL - for measles; ≥ 500 U/mL (ELISA) or ≥ 60 (1/dil) in the neutralization assay when the ELISA concentration was less than 500 mIU/mL - for mumps; ≥ 10 IU/mL (ELISA) - for Rubella; and ≥ 300 mIU/mL (ELISA) or ≥ 4 (1/dil) Fluorescent antibody to membrane antigen (FAMA) when the ELISA concentration was less than 300 mIU/mL - for varicella.|Day 30 after the 12-month vaccination|Antibody responses were evaluated in the per-protocol population.||Percentage of Participants|||Number
733747|NCT00422383|Secondary|Percentage of Participants With Positive Recall Antigen Antibody Titers|A positive titer result to recall antigens was defined as a serum antibody level equal to or above the following protective levels: tetanus toxoid ≥ 0.1 IU/mL, influenza A > 12 U/mL, influenza B > 12 U/mL, and streptococcus (S.) pneumococcus ≥ 1.0 mg/L.|BL, Weeks 24 and 48|SAP, n=number of participants assessed for the given parameter at the specified timepoint.||percentage of participants|||Number
733748|NCT00422383|Secondary|Percentage of Participants With a Change From BL by Category in Anti-Nuclear Antibodies (ANA) Titers|ANA titers were obtained by the following serum dilution schema: negative = negative, borderline = 1 diluted to (:) 40 or 1:80, and positive ≥ 1:160. The change categories were defined for the change from BL to Weeks 24 and 48 according to this schema. Negative to borderline was defined as any change from negative to borderline as no dilution is given for negative results. Negative to positive was defined as at least a two-fold positive change in dilution from BL. Borderline to negative was defined as any change from borderline to negative as no dilution is given for negative results. Borderline to positive was defined as at least a two-fold positive change in dilution from BL. Positive to borderline was defined as at least a two-fold negative change in dilution from BL. Positive to negative was defined as at least a two-fold negative change in dilution from BL. Unchanged was defined as any difference in dilution less than two-fold.|BL, Weeks 24 and 48|SAP, n=number of participants assessed for the given parameter at the specified timepoint.||percentage of participants|||Number
733749|NCT00422383|Secondary|Percentage of Participants With Positive Human Anti-Chimeric Antibody (HACA) Titers|A participant was defined as being HACA positive if the HACA serum level was ≥ 5 relative units (RU) per mL and the physician comment read that participant was “immunodepletable with rituximab”.|BL, Weeks 24 and 48|SAP, n=number of participants assessed for the given parameter at the specified timepoint.||percentage of participants|||Number
733750|NCT00422383|Secondary|Change From BL in Activated Complement Component 4a (C4a) Protein Level in g/L||BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint||g/L||Standard Deviation|Mean
733751|NCT00422383|Secondary|Change From BL in Complement C4 Protein Level in g/L||BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint||g/L||Standard Deviation|Mean
733752|NCT00422383|Secondary|Percentage of Participants With Complement Component 4 (C4) Protein Level ≤ LLN|The LLN of C4 protein was defined as < 0.1 g/L.|BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint||percentage of participants|||Number
733760|NCT00422383|Secondary|Change From BL in Peripheral CD16+56+ Cell Count|Simultaneous surface expression of CD16 and CD56 was assessed by FACS analysis as a marker of NK cell count.|BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint.||cells/µL||Standard Deviation|Mean
733761|NCT00422383|Secondary|Peripheral CD16+56+ Natural Killer (NK) Cell Count in Cells/µL|Simultaneous surface expression of CD16 and CD56 was assessed by FACS analysis as a marker of NK cell count.|BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint.||cells/µL||Standard Deviation|Mean
733762|NCT00422383|Secondary|Change From BL in Peripheral CD8+ Cell Count|Surface expression of CD8 was assessed by FACS analysis as a marker of cytotoxic T lymphocyte count. The normal range of CD8+ T cells was defined as 220-1129 cells/µL.|BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint.||cells/µL||Standard Deviation|Mean
733763|NCT00422383|Secondary|Peripheral CD8+ T Cell Count in Cells/µL|Surface expression of CD8 was assessed by FACS analysis as a marker of cytotoxic T lymphocyte count. The normal range of CD8+ T cells was defined as 220-1129 cells/µL.|BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint.||cells/µL||Standard Deviation|Mean
733764|NCT00422383|Secondary|Change From BL in Peripheral CD4+ T Cell Count|Surface expression of CD4 was assessed by FACS analysis as a marker of T helper cell count. The normal range of CD4+ T cells was defined as 404-1612 cells/µL.|BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint.||cells/µL||Standard Deviation|Mean
733765|NCT00422383|Secondary|Peripheral CD4+ T Cell Count in Cells/µL|Surface expression of CD4 was assessed by FACS analysis as a marker of T helper cell count. The normal range of CD4+ T cells was defined as 404-1612 cells/µL.|BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint.||cells/µL||Standard Deviation|Mean
733766|NCT00422383|Secondary|Change From BL in Peripheral CD3+ T Cell Count|Surface expression of CD3 was assessed by FACS analysis as a marker of absolute T lymphocyte count. The normal range of CD3+ T cells was defined as 723-2737 cells/µL.|BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint.||cells/µL||Standard Deviation|Mean
733767|NCT00422383|Secondary|Peripheral CD3+ T Cell Count in Cells/µL|Surface expression of CD3 was assessed by FACS analysis as a marker of absolute T lymphocyte count. The normal range of CD3+ T cells was defined as 723-2737 cells/µL.|BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint.||cells/µL||Standard Deviation|Mean
733768|NCT00422383|Secondary|Peripheral CD19+CD27 Negative (-) B Cell Count in Cells/µL|Surface expression of CD19 in the absence of CD27 expression was assessed by FACS analysis as a marker of naive B lymphocyte count.|BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint.||cells/µL||Standard Deviation|Mean
733769|NCT00422383|Secondary|Peripheral CD19+CD27+ B Cell Count in Cells/µL|Simultaneous surface expression of CD19 and CD27 was assessed by FACS analysis as a marker of memory B lymphocyte count.|BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint.||cells/µL||Standard Deviation|Mean
733770|NCT00422383|Secondary|Peripheral CD22+ B Cell Count in Cells/µL|Surface expression of CD22 was assessed by FACS analysis as a marker of mature lymphocyte count.|BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint.||cells/µL||Standard Deviation|Mean
733771|NCT00422383|Secondary|Peripheral CD20+ B Cell Count in Cells/µL|Surface expression of CD20 was assessed by FACS analysis as a marker of mature and memory B lymphocyte count.|BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|The safety analysis population (SAP) = ITT-M2 population, n = number of participants assessed for the given parameter at the specified timepoint.||cells/µL||Standard Deviation|Mean
733772|NCT00422383|Secondary|Percentage of Participants With Peripheral CD19+ B Cell Counts Above BL or the Lower Limit of Normal (LLN)|Surface expression of CD19 was assessed by FACS analysis as a marker of absolute B lymphocyte count. The LLN was defined as < 80 cells/µL.|BL, Days 1 and 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|ITT-M2 population, n = number of participants assessed for the given parameter at the specified timepoint.||percentage of participants|||Number
733773|NCT00422383|Secondary|Peripheral Cluster of Differentiation (CD) 19 Positive (+) B Cell Count at BL in Cells Per Microliter (Cells/µL)|Surface expression of CD19 was assessed by fluorescence-activated cell sorting (FACS) analysis as a marker of absolute B lymphocyte count.|BL|ITT-M2 population. 7, 8, 3, 1, and 2 participants were not analyzed for this outcome measure from the Low Dose, Escalated Dose, High Dose, Placebo, and Decreased Dose groups, respectively.||cells/µL||Standard Deviation|Mean
733774|NCT00422383|Secondary|Terminal Elimination Half-Life (t1/2) in the 1st and 2nd Courses of Treatment in Days|t1/2 values were estimated from rituximab serum concentrations by non-compartmental methods using the software WinNonlin Enterprise Version 5.2.|Days 1 and 15 (before infusion and 30 minutes following infusion) and Weeks 4, 8, 16, 24, 26, 28, 32, 40, and 48 or early withdrawal and at Weeks 24 and 48 of safety follow-up (1 year period following the completion of study treatment).|ITT-M2 population, n = number of participants assessed for the given parameter at the specified timepoint.||days||Standard Deviation|Mean
733775|NCT00422383|Secondary|Maximum Observed Serum Concentrations Following the 2nd Infusion of Rituximab (Csecond) in the 1st and 2nd Courses of Treatment in µg/mL|Csecond values were estimated from rituximab serum concentrations by non-compartmental methods using the software WinNonlin Enterprise Version 5.2.|Days 1 and 15 (before infusion and 30 minutes following infusion) and Weeks 4, 8, 16, 24, 26, 28, 32, 40, and 48 or early withdrawal and at Weeks 24 and 48 of safety follow-up (1 year period following the completion of study treatment).|ITT-M2 population, n = number of participants assessed for the given parameter at the specified timepoint.||µg/mL||Standard Deviation|Mean
733801|NCT00413777|Secondary|Percent Change From Baseline in Renal Volume.|Total Kidney Volume (TKV) was assessed by the central magnetic resonance imaging (MRI) rater.|Baseline to Month 36|The ITT dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. OC dataset were used.||Percentage change per month||Standard Deviation|Mean
733776|NCT00422383|Secondary|Maximum Observed Serum Concentrations Following the 1st Infusion of Rituximab (Cfirst) in the 1st and 2nd Courses of Treatment in Micrograms Per mL (µg/mL)|Cfirst values were estimated from rituximab serum concentrations by non-compartmental methods using the software WinNonlin Enterprise Version 5.2.|Days 1 and 15 (before infusion and 30 minutes following infusion) and Weeks 4, 8, 16, 24, 26, 28, 32, 40, and 48 or early withdrawal and at Weeks 24 and 48 of safety follow-up (1 year period following the completion of study treatment).|ITT-M2 population, n = number of participants analyzed for the given parameter at the specified timepoint.||µg/mL||Standard Deviation|Mean
733777|NCT00422383|Secondary|Change in SF-36 Score From BL|SF-36 scores were obtained by scoring participants' responses to a 36 item questionnaire. SF-36 evaluated 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health from a range of 1 (better) to 5 (worst). The score for each section was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). These 8 aspects were summarized as physical and mental component scores.|BL, Weeks 24 and 48|ITT-M2 population, n = number of participants analyzed for the given parameter at the specified timepoint.||score on a scale||Standard Deviation|Mean
733778|NCT00422383|Secondary|Short-Form 36 Health Survey (SF-36) Score|SF-36 scores were obtained by scoring participants' responses to a 36 item questionnaire. SF-36 evaluated 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health from a range of 1 (better) to 5 (worst). The score for each section was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). These 8 aspects were summarized as physical and mental component scores.|BL, Week (Wk) 24 and 48|ITT-M2 population, n (number) = number of participants analyzed for the given parameter at the specified timepoint.||score on a scale||Standard Deviation|Mean
733779|NCT00422383|Secondary|Change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score From BL at Week 48|"FACIT-F scores were obtained from a 13 question self-administered participant questionnaire designed to measure the degree of fatigue experienced by participants in the previous 7 days. Participants responded to the questions using a value between 0 and 4, where 0 indicated not at all and 4 indicated very much. 11 of the 13 questions were negatively stated; indicating the higher the score of the participant's response, the greater their fatigue. These questions were calculated as 4 minus the participants' response, so that a higher score indicated an improvement in health. The scores for the 2 positively stated questions were not changed. The participants' responses were summed to result in an overall score, which are scored 0 to 52 (52 = highest level of functioning). A positive change from BL indicated improvement."|BL, Week 48|ITT-M2 population. 9, 4, 2, and 1 participants were not evaluated for this outcome measure from the Low Dose, Escalated Dose, High Dose, and Decreased Dose groups, respectively.||score on a scale||Standard Deviation|Mean
733780|NCT00422383|Secondary|Percentage of Participants With a Response at Week 48 by European League Against Rheumatism (EULAR) Category|EULAR responses were categorized according to DAS28-ESR score. DAS28-ESR ≤ 3.2 at Week 48 and a change from BL to Week 48 < -1.2 = good response, DAS28-ESR ≤ 3.2 or greater than (>) 3.2 and ≤ 5.1 at Week 48 and a change from BL to Week 48 < -0.6 and ≥ -1.2 = moderate response, DAS28-ESR > 3.2 and ≤ 5.1 at Week 48 and a change from BL to Week 48 < -1.2 = moderate response, DAS28-ESR > 5.1 at Week 48 and a change from BL to Week 48 < -1.2 = moderate response, DAS28-ESR ≤ 3.2 or > 3.2 and ≤ 5.1 at Week 48 and a change from BL to Week 48 ≥ -0.6 = no response, DAS28-ESR > 5.1 at Week 48 and a change from BL to Week 48 < -0.6 and ≥ -1.2 or ≥ -0.6 = no response.|Week 48|ITT-M2 population||percentage of participants|||Number
733781|NCT00422383|Secondary|Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR): Adjusted Mean Change From BL at Week 48|DAS28 was calculated according to the following formula: DAS28 equals (=) [0.56 multiplied by (*) the square root (√) of TJC] plus (+) [0.28 * √ of SJC] + (0.70 * the natural logarithm (ln) ESR in millimeters per hour (mm/h)] + [0.014 * participant's global assessment of disease activity (GH)]. DAS28-ESR ≥ 5.1 = high disease activity, DAS28-ESR less than or equal to (≤) 3.2 = low disease activity, DAS28-ESR less than (<) 2.6 = remission.|BL, Week 48|ITT-M2 population. Two participants from the Low Dose group and 1 participant from the Escalated Dose group were not evaluated for this outcome measure.||score on a scale||95% Confidence Interval|Mean
733782|NCT00422383|Secondary|Percentage of Participants With a ACR 70% Improvement Criteria (ACR70) Response at Week 48|ACR70 was defined as an overall score of 70 in the ACRn calculation. The Overall score defined as lowest percent improvement from BL of following 3 measures: TJC (68 joints), SJC (66 joints), and the 3rd lowest improvement achieved by at least 3 of 5 remaining ACR core parameters: physician’s global assessment of disease activity, participant’s global assessment of disease activity, participant's assessment of pain (VAS), HAQ, and CRP. If CRP missing, ESR was used. In order for improvements in the ACRn score to be expressed as a positive result, rather than the negative changes that improvements represent, the final ACRn results were multiplied by negative 1. LOCF for TJC/SJC, HAQ, CRP/ESR, VAS. If change in CRP incalculable, change in ESR used. ACR70 set to Non-Responder if ACRn missing.|Week 48|ITT-M2 population||percentage of participants|||Number
733783|NCT00422383|Secondary|Percentage of Participants With ACR 50% Improvement Criteria (ACR50) Response at Week 48|ACR50 was defined as an overall score of 50 in the ACRn calculation. Overall score defined as lowest percent improvement from BL of following 3 measures: TJC (68 joints), SJC (66 joints), and the 3rd lowest improvement achieved by at least 3 of 5 remaining ACR core parameters: physician’s global assessment of disease activity, participant’s global assessment of disease activity, participant's assessment of pain (VAS), HAQ, and CRP. If CRP missing, ESR was used. In order for improvements in the ACRn score to be expressed as a positive result, rather than the negative changes that improvements represent, the final ACRn results were multiplied by negative 1. LOCF for TJC/SJC, HAQ, CRP/ESR, VAS. If change in CRP incalculable, change in ESR used. ACR50 set to Non-Responder if ACRn missing.|Week 48|ITT-M2 population||percentage of participants|||Number
733812|NCT00413894|Secondary|Percentage of Participants With Hb Levels Within 10.0-13.0 g/dL During Screening Phase||Visits 1 to 2 (Months -2 to -1)|ITT Population||percentage of participants|||Number
733813|NCT00413894|Secondary|Percentage of Participants With Hb Levels Within 11.0-12.5 g/dL During Screening Phase||Visits 1 to 2 (Months -2 to -1)|ITT Population: All participants having received at least one dose of study medication and having at least one Hb value measurement under C.E.R.A. were included.||percentage of participants|||Number
733784|NCT00422383|Primary|Percentage of Participants With a Response as Determined by American College of Rheumatology (ACR) 20% Improvement (ACR20)|ACR20 defined as overall score of ≥20 in ACR number (ACRn) calculation. Overall score defined as lowest percent improvement from baseline (BL) of following 3 measures: tender joint count (TJC; 68 joints), swollen joint count (SJC: 66 joints), and the 3rd lowest improvement achieved by at least 3 of 5 remaining ACR core parameters: physician’s global assessment of disease activity, participant’s global assessment of disease activity, participant's assessment of pain (visual analog assessment [VAS]), Health Assessment Questionnaire (HAQ), and C-Reactive Protein (CRP). If CRP missing, erythrocyte sedimentation rate (ESR) was used. In order for improvements in the ACRn score to be expressed as a positive result, rather than the negative changes that improvements represent, the final ACRn results were multiplied by negative 1. Last observation carried forward (LOCF) for TJC/SJC, HAQ, CRP/ESR, VAS. If change in CRP incalculable, change in ESR used. ACR20 set to Non-Responder if ACRn missing|Week 48|ITT-M2 population||percentage of participants||95% Confidence Interval|Number
733785|NCT00413777|Secondary|Mean Change From Baseline in Abdominal Girth Measurement- Extension.|The participant had a measurement of their abdominal girth recorded. The measurement will be taken with a tape measure extending around the abdomen at the level of the iliac crests laterally and the umbilicus anteriorly. The examiner should also palpate for each kidney and liver edge, noting presence or enlargement. (By definition if the kidneys are palpable they are enlarged, the liver edge may be palpable but not enlarged).|Baseline to Extension Day 1, Extension Month 12|The ITT dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. OC dataset were used.||cm||Standard Deviation|Mean
733786|NCT00413777|Secondary|Mean Change From Baseline in Abdominal Girth Measurement.|The participant had a measurement of their abdominal girth recorded. The measurement will be taken with a tape measure extending around the abdomen at the level of the iliac crests laterally and the umbilicus anteriorly. The examiner should also palpate for each kidney and liver edge, noting presence or enlargement. (By definition if the kidneys are palpable they are enlarged, the liver edge may be palpable but not enlarged).|Baseline to Month 36|The ITT dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. OC dataset were used.||cm||Standard Deviation|Mean
733787|NCT00413777|Secondary|Mean Change From Baseline in Patient-assessed Renal Pain Scale- Extension.|Participants were asked the question to assess the relative level of pain attributed to their kidneys. This question was, “On a scale of 0 to 10, with zero represented no pain at all and 10 represented the worst pain ever experienced, what was the worst kidney pain experienced in the last 4 months?” If the latest assessment was less than 4 months prior, the question was substituted “since your last visit” for “in the last 4 months”. The same interrogator designated to this task was used throughout the study for each participant.|Baseline to Months 2, 6, 12, 24, 36, Extension Day 1, Extension Month 12|The ITT dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. OC dataset were used.||Units on a scale||Standard Deviation|Mean
733788|NCT00413777|Secondary|Mean Change From Baseline in Patient-assessed Renal Pain Scale.|Participants were asked the question to assess the relative level of pain attributed to their kidneys. This question was, “On a scale of 0 to 10, with zero represented no pain at all and 10 represented the worst pain ever experienced, what was the worst kidney pain experienced in the last 4 months?” If the latest assessment was less than 4 months prior, the question was substituted “since your last visit” for “in the last 4 months”. The same interrogator designated to this task was used throughout the study for each participant.|Baseline to Month 36|The ITT dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. OC dataset were used.||Units on a scale||Standard Deviation|Mean
733789|NCT00413777|Secondary|Mean Change From Baseline in MAP for Hypertension Assessment- Extension.|The participants were seated and resting systolic and diastolic BP for each scheduled assessment was recorded. At each assessment, participants were categorized (based on repeated blood pressure measurements as being normotensive (MAP < 100 mm Hg and off therapy), high normal (sBP > 129 and or dBP > 84 mm Hg off therapy) or hypertensive (sBP >140 and/or dBP > 90 mm Hg). The mean arterial pressure (MAP) was derived from these values and were not recorded (MAP = diastolic pressure + [1/3 x pulse pressure (ie systolic - diastolic pressure)] in mm Hg).|Baseline to Months 2, 6, 9, 12, 16, 20, 24, 28, 32, 36, Extension Day 1, Extension Month 4, Extension Month 8, Extension Month 12|The ITT dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. OC dataset were used.||mmHg||Standard Deviation|Mean
733790|NCT00413777|Secondary|Mean Change From Baseline in dBP for Hypertension Assessment- Extension.|The participants were seated and resting systolic and diastolic BP for each scheduled assessment was recorded. At each assessment, participants were categorized (based on repeated blood pressure measurements as being normotensive (MAP < 100 mm Hg and off therapy), high normal (sBP > 129 and or dBP > 84 mm Hg off therapy) or hypertensive (sBP >140 and/or dBP > 90 mm Hg). The mean arterial pressure (MAP) was derived from these values and were not recorded (MAP = diastolic pressure + [1/3 x pulse pressure (ie systolic - diastolic pressure)] in mm Hg).|Baseline to Months 2, 6, 9, 12, 16, 20, 24, 28, 32, 36, Extension Day 1, Extension Month 4, Extension Month 8, Extension Month 12|The ITT dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. OC dataset were used.||mmHg||Standard Deviation|Mean
733791|NCT00413777|Secondary|Mean Change From Baseline in sBP for Hypertension Assessment- Extension.|The participants were seated and resting systolic and diastolic BP for each scheduled assessment was recorded. At each assessment, participants were categorized (based on repeated blood pressure measurements as being normotensive (MAP < 100 mm Hg and off therapy), high normal (sBP > 129 and or dBP > 84 mm Hg off therapy) or hypertensive (sBP >140 and/or dBP > 90 mm Hg). The mean arterial pressure (MAP) was derived from these values and were not recorded (MAP = diastolic pressure + [1/3 x pulse pressure (ie systolic - diastolic pressure)] in mm Hg).|Baseline to Months 2, 6, 9, 12, 16, 20, 24, 28, 32, 36, Extension Day 1, Extension Month 4, Extension Month 8, Extension Month 12|The ITT dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. OC dataset were used.||mmHg||Standard Deviation|Mean
733860|NCT00422422|Primary|Mean Max Plasma Concentration for Age Range ≥2 to <12 Years||Day 21|||ug/mL||Full Range|Mean
733792|NCT00413777|Secondary|Mean Change From Baseline in Mean Arterial Pressure (MAP) for Hypertension Assessment.|The participants were seated and resting systolic and diastolic BP for each scheduled assessment was recorded. At each assessment, participants were categorized (based on repeated blood pressure measurements as being normotensive (MAP < 100 mm Hg and off therapy), high normal (sBP > 129 and or dBP > 84 mm Hg off therapy) or hypertensive (sBP >140 and/or dBP > 90 mm Hg). The mean arterial pressure (MAP) was derived from these values and were not recorded (MAP = diastolic pressure + [1/3 x pulse pressure (ie systolic - diastolic pressure)] in mm Hg).|Baseline to Month 36|The ITT dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. OC dataset were used.||mmHg||Standard Deviation|Mean
733793|NCT00413777|Secondary|Mean Change From Baseline in Diastolic Blood Pressure (dBP) for Hypertension Assessment.|The participants were seated and resting systolic and diastolic BP for each scheduled assessment was recorded. At each assessment, participants were categorized (based on repeated blood pressure measurements as being normotensive (MAP < 100 mm Hg and off therapy), high normal (sBP > 129 and or dBP > 84 mm Hg off therapy) or hypertensive (sBP >140 and/or dBP > 90 mm Hg). The mean arterial pressure (MAP) was derived from these values and were not recorded (MAP = diastolic pressure + [1/3 x pulse pressure (ie systolic - diastolic pressure)] in mm Hg).|Baseline to Month 36|The ITT dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. OC dataset were used.||mmHg||Standard Deviation|Mean
733794|NCT00413777|Secondary|Mean Change From Baseline in Systolic Blood Pressure (sBP) for Hypertension Assessment.|The participants were seated and resting systolic and diastolic BP for each scheduled assessment was recorded. At each assessment, participants were categorized (based on repeated blood pressure measurements as being normotensive (MAP < 100 mm Hg and off therapy), high normal (sBP > 129 and or dBP > 84 mm Hg off therapy) or hypertensive (sBP >140 and/or dBP > 90 mm Hg). The mean arterial pressure (MAP) was derived from these values and were not recorded (MAP = diastolic pressure + [1/3 x pulse pressure (ie systolic - diastolic pressure)] in mm Hg).|Baseline to Month 36|The ITT dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. OC dataset were used.||mmHg||Standard Deviation|Mean
733795|NCT00413777|Secondary|Change From Pre-dose Baseline in Renal Function Estimated by GFR- Extension.|GFR was estimated using reciprocal serum creatinine formula. The formula does not adjust for body weight or height, but this may be done to normalize to body surface area. The formula for reciprocal Serum creatinine is: 1/Pcr. (Pcr = serum creatinine concentration [mg/dL]). Clinic weight scales were calibrated at least yearly.|Baseline to Months 2, 6, 9, 12, 16, 20, 24, 28, 32, 36, Extension Day 1, Extension Month 12|The ITT dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. OC dataset were used.||dL/mg||Standard Deviation|Mean
733796|NCT00413777|Secondary|Percent Change From Baseline in Renal Volume-Extension.|TKV was assessed by the central magnetic resonance imaging (MRI) rater.|Baseline to Months 2, 12, 24, 36, Extension Day 1, Extension Month 12|The ITT dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. OC dataset were used.||Percentage change per month||Standard Deviation|Mean
733797|NCT00413777|Secondary|Mean Change From Baseline in Trough Urine Osmolality at Steady State Prior to Bedtime- Extension.|"Urine osmolality at steady state (after at least 4 days of dosing) including “average of troughs” (the mean urine osmolality prior to bedtime).
Samples for this assessment were to be taken as closely coincident to PK blood sample as practical. During Weeks 1, 2, 3 and 4 of the Titration Period and at Month 6, additional samples were collected for the preceding day at bedtime. These samples allowed derivation of an average nadir of spot urine osmolality concentrations at each dose level and while at steady state during extended tolvaptan administration."|Baseline to Month 24|The ITT dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. OC dataset were used.||mOsm/kg||Standard Deviation|Mean
733798|NCT00413777|Secondary|Mean Change From Baseline in Trough Urine Osmolality at Steady State Prior to Second Daily Dose- Extension.|"Urine osmolality at steady state (after at least 4 days of dosing) including “absolute trough” prior to the second daily dose.
Samples for this assessment were taken as closely coincident to PK blood sample as practical. During Weeks 1, 2, 3 and 4 of the Titration Period and at Month 6, additional samples were collected for the preceding day immediately preceding the second daily dose. These samples allowed derivation of an average nadir of spot urine osmolality concentrations at each dose level and while at steady state during extended tolvaptan administration."|Baseline to Month 24|The ITT dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. OC dataset were used.||mOsm/kg||Standard Deviation|Mean
733799|NCT00413777|Secondary|Mean Change From Baseline in Trough Urine Osmolality at Steady State Prior to First Daily Dose- Extension.|Spot urine osmolality at trough was determined for urine samples collected immediately prior to morning dosing for Day 1 (Baseline), Months 2, 6, 12, 24, 36, Extension Day 1, and Extension Month 12 for all participants. Sample was taken after the first morning’s void and was provided as a mid-stream, clean catch sample. During the titration period (Weeks 1, 2, 3 and 4) and at Month 6, additional samples were collected for the preceding day immediately preceding the 2nd daily dose and at bed-time. These samples allowed derivation of an average nadir of spot urine osmolality concentrations at each dose level and while at steady state during extended tolvaptan administration. At the Month 36 visit, participants were given a urine container and brought back the specimen at Extension Day 1. All participants were fasting.|Baseline to Months 2, 6, 12, 24, 36, Extension Day 1, Extension Month 12|The intent-to-treat (ITT) dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. Observed cases (OC) dataset were used.||mOsm/kg||Standard Deviation|Mean
733800|NCT00413777|Secondary|Change From Pre-dose Baseline in Renal Function Estimated by Glomerular Filtration Rate (GFR).|GFR was estimated using reciprocal serum creatinine formula. The formula does not adjust for body weight or height, but this may be done to normalize to body surface area. The formula for reciprocal Serum creatinine is: 1/Pcr. (Pcr = serum creatinine concentration [mg/dL]). Clinic weight scales were calibrated at least yearly.|Baseline to Month 36|The ITT dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. OC dataset were used.||dL/mg||Standard Deviation|Mean
733802|NCT00413777|Secondary|Mean Change From Baseline in Trough Urine Osmolality at Steady State Prior to Bedtime.|"Urine osmolality at steady state (after at least 4 days of dosing) including “average of troughs” (the mean urine osmolality prior to bedtime).
Samples for this assessment were to be taken as closely coincident to PK blood sample as practical. During Weeks 1, 2, 3 and 4 of the Titration Period and at Month 6, additional samples were collected for the preceding day at bedtime. These samples allowed derivation of an average nadir of spot urine osmolality concentrations at each dose level and while at steady state during extended tolvaptan administration."|Baseline to Month 24|The ITT dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. OC dataset were used.||mOsm/kg||Standard Deviation|Mean
733803|NCT00413777|Secondary|Mean Change From Baseline in Trough Urine Osmolality at Steady State Prior to Second Daily Dose.|"Urine osmolality at steady state (after at least 4 days of dosing) including “absolute trough” prior to the second daily dose.
Samples for this assessment were taken as closely coincident to PK blood sample as practical. During Weeks 1, 2, 3 and 4 of the Titration Period and at Month 6, additional samples were collected for the preceding day immediately preceding the second daily dose. These samples allowed derivation of an average nadir of spot urine osmolality concentrations at each dose level and while at steady state during extended tolvaptan administration."|Baseline to Month 24|The ITT dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. OC dataset were used.||mOsm/kg||Standard Deviation|Mean
733804|NCT00413777|Secondary|Mean Change From Baseline in Trough Urine Osmolality at Steady State Prior to First Daily Dose.|Spot urine osmolality at trough was determined for urine samples collected immediately prior to morning dosing for Day 1 (Baseline), Months 2, 6, 12, 24, 36 for all participants. Sample was taken after the first morning’s void and was provided as a mid-stream, clean catch sample. During the titration period (Weeks 1, 2, 3 and 4) and at Month 6, additional samples were collected for the preceding day immediately preceding the 2nd daily dose and at bed-time. These samples allowed derivation of an average nadir of spot urine osmolality concentrations at each dose level and while at steady state during extended tolvaptan administration. At the Month 36 visit, participants were given a urine container and brought back the specimen at Extension Day 1. All participants were fasting.|Baseline to Month 36|The intent-to-treat (ITT) dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. Observed cases (OC) dataset were used.||mOsm/kg||Standard Deviation|Mean
733805|NCT00413777|Primary|Safety Assessments Based on Vital Signs, Electrocardiogram (ECG's), Clinical Laboratory Tests, Physical Examinations Are Reported as Adverse Events (AEs) Upon Study Physician Discretion.|An AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a participant while enrolled in a study , whether or not it was considered drug-related by the study physician. A treatment-emergent AE (TEAE) was defined as an AE that started after start of study drug treatment; or if the event was continuous from Baseline and was serious, study drug related, or resulted in death, discontinuation.|AEs were recorded from screening (ICF was signed) until 7-Day follow-up|Safety dataset was defined as all participants who consumed at least 1 dose of study medication. Safety variables analyzed included physical examinations, laboratory tests, vital signs, ECG's and AEs.||participants|||Number
733806|NCT00413894|Secondary|Percentage of Participants Requiring Erythrocyte Transfusions||Visits 1 to 10 (Months -2 to 8)|Safety Population (SAF): All participants who received at least one dose of study medication independent from whether they completed the study or not were included into the safety analysis.||percentage of participants|||Number
733807|NCT00413894|Secondary|Percentage of Participants With Hb Fluctuations Within Screening Phase|Hematology and clinical chemistry were performed partially by a central laboratory as well as by the local laboratories by means of their established methods. Normal ranges and methods as well as quality assurance certificates had to be available to the sponsor prior to the start of the study. Hb fluctuation was defined as the deviation from individual mean Hb-value within the study phase (Screening Phase) and was categorized as ≤ ±1 g/dL, >±1.0 to ±1.5 g/dL, >±1.5 to ±2.0 g/dL, and >±2.0 g/dL. Percentage of participants within these deviation categories are reported for Screening Phase of the study.|Visits 1 to 2 (Months -2 to -1)|ITT Population||percentage of participants|||Number
733808|NCT00413894|Secondary|Percentage of Participants With Hb Fluctuations Within Evaluation Phase|Hb fluctuation was defined as the deviation from individual mean Hb-value within the study phase (Evaluation Phase) and was categorized as less than or equal to (≤) ±1 g/dL, greater than (>) ±1.0 to ±1.5 g/dL, > ±1.5 to ±2.0 g/dL, and > ±2.0 g/dL. Percentage of participants within these deviation categories were reported for Evaluation Phase of the study.|Visits 8 to 10 (Months 6 to 8)|ITT population||percentage of participants|||Number
733809|NCT00413894|Secondary|Percentage of Participants With Changes Between Screening and Evaluation Phase With Respect To Hb Levels|"Shifts in Hb levels between Screening and Evaluation Phase were classified as follows: Category A: Participants with Hb levels in both Screening and Evaluation Phase within 10-13 g/dL; Category B: Participants who had Hb values within 10-13 g/dL during Screening but shifted outside the range during Evaluation; Category C: Participants who had Hb values outside range during Screening but shifted to stable values (at least within 10 - 13 g/dL) during Evaluation.; Category D: Participants with less than two values available during Evaluation Phase.
Participants could appear in only 1 category. Participants had to have 2 or 3 values within range (depending on the number of measurements available) to be counted."|Visits 1 to 2 (Months -2 to -1) and Visits 8 to 10 (Months 6 to 8)|ITT Population;||percentage of participants|||Number
733810|NCT00413894|Secondary|Percentage of Participants With HbLevels Within 10.0-13.0 g/dL by Dose Modification During Screening Phase|Dose adjustment included increase or decrease in dose. Percentage of participants with Hb levels within 11.0-12.5 g/dL by dose adjustment categories (with dose adjustment and without dose adjustment) were reported.|Visits 1 to 2 (Months -2 to -1)|ITT Population; n = number of participants in the specified category||percentage of participants|||Number
733811|NCT00413894|Secondary|Percentage of Participants With Hb Levels Within 11.0-12.5 g/dL by Dose Modification During Screening Phase|Dose adjustment included increase or decrease in dose. Percentage of participants with Hb levels within 11.0-12.5 g/dL by dose adjustment categories (with dose adjustment and without dose adjustment) were reported.|Visits 1 to 2 (Months -2 to -1)|ITT Population; n = number of participants in the specified category||percentage of participants|||Number
733861|NCT00422422|Primary|Mean Max Plasma Concentration for Age Range ≥1 Month to <2 Years||Day 21|||ug/mL||Full Range|Mean
733814|NCT00413894|Primary|Percentage of Participants With Hemoglobin Levels Within 10.0-13.0 g/dL by Dose Modification During Evaluation Phase|Dose adjustment included increase or decrease in dose. Percentage of participants with Hb levels within 11.0-12.5 g/dL by dose adjustment categories (with dose adjustment and without dose adjustment) were reported.|Visits 8 to 10 (Months 6 to 8)|CP; n = number of participants in the specified category||percentage of participants|||Number
733815|NCT00413894|Primary|Percentage of Participants With Hb Levels Within 11.0-12.5 g/dL by Dose Modifications During Evaluation Phase|Dose adjustment included increase or decrease in dose. Percentage of participants with Hb levels within 11.0-12.5 g/dL by dose adjustment categories (with dose adjustment and without dose adjustment) were reported.|Visits 8 to 10 (Months 6 to 8)|CP; number (n) equals (=) number of participants in the specified category||percentage of participants|||Number
733816|NCT00413894|Primary|Percentage of Participants With Hb Levels Within 10.0-13.0 g/dL During Evaluation Phase||Visits 8 to 10 (Months 6 to 8)|CP||percentage of participants|||Number
733817|NCT00413894|Primary|Percentage of Participants With Hb Levels Within 11.0-12.5 Grams Per Deciliter (g/dL) During Evaluation Phase||Visits 8 to 10 (Months 6 to 8)|Completer Population (CP) included only participants who completed the study until Visit 10 (Month 8).||percentage of participants|||Number
733818|NCT00413920|Secondary|Number of Participants Requiring Steroids in Non-steroid Treatment Group||Months 3 and 6|||Number of participants|||Number
733819|NCT00413920|Secondary|Number of Participants With Treatment Failure at 3 Months by Graft Recovery Status|"The number of participants with treatment failure defined as a Biopsy Proven Acute Rejection (BPAR), a graft loss, a death, or a loss to follow-up at 3 months by graft recovery status.
Delayed graft function is defined as the need for dialysis within the first 7 days post-transplantation, excluding the first post-transplantation day.
Slow graft function is defined as a serum creatinine value > 250 µmol/L at day 5."|Month 3|Intent-to-treat population. N in the categories is the number of participants from the total population that fit into that category for each arm/group. For example: in the Delayed Graft Function category there were 25 participants in the Without steroid group and 24 participants in the With Steroid Group.||Number of participants|||Number
733820|NCT00413920|Secondary|Number of Participants With Subclinical Histological Rejections|The number of participants with subclinical histological rejections was determined by renal biopsy screening at 3 months in 125 patients, providing adequate samples for 112 biopsies.|Month 3|Intent-to-treat population on whom biopsies were performed at 3 months.||Number of participants|||Number
733821|NCT00413920|Secondary|Number of Participants With Treatment Failure, BPAR, Clinical Acute Rejection (AR) and Treated AR at 3 Months|A treatment failure is a Biopsy Proven Acute Rejection (BPAR), a graft loss, a death, or a loss to follow-up. Only BPAR from other biopsies than the protocol defined biopsy at Month 3 are described. Acute rejection: an episode of acute renal dysfunction diagnosed as rejection on the basis of biopsy or clinical observations, treated with anti-rejection medication. BPAR: renal transplant biopsy finding of acute cellular or antibody mediated rejection. Graft loss: The allograft will be presumed lost on the day the patient starts dialysis and is not able to subsequently be removed from dialysis.|Month 3|Intent-to-treat population||Number of participants|||Number
733822|NCT00413920|Secondary|The Number of Participants With BPAR, Clinical Acute Rejection (AR) and Treated AR at 6 Months|If a participant experienced several BPAR, only the rejection with highest grade is taken into account. Only events that occurred before study treatment discontinuation are taken into account. Only BPAR from other biopsies than the protocol defined biopsy at Month 3 are described. Acute rejection: an episode of acute renal dysfunction diagnosed as rejection on the basis of biopsy or clinical observations, treated with anti-rejection medication. BPAR: renal transplant biopsy finding of acute cellular or antibody mediated rejection.|Month 6|Intent-to-treat population||Number of participants|||Number
733823|NCT00413920|Primary|Number of Participants With the Occurrence of Treatment Failures at 6 Months Post-transplantation|Treatment failures defined as Biopsy Proven Acute Rejection (BPAR), graft loss, death or loss to follow-up. Only BPAR from other biopsies than the protocol defined biopsy at Month 3 are described. Acute rejection: an episode of acute renal dysfunction diagnosed as rejection on the basis of biopsy or clinical observations, treated with anti-rejection medication. BPAR: renal transplant biopsy finding of acute cellular or antibody mediated rejection. Graft loss: allograft will be presumed to be lost on the day the patient starts dialysis and is not able to subsequently be removed from dialysis.|6 months post transplantation|Intent-to-treat population||Number of participants|||Number
733824|NCT00413959|Secondary|Overall Survival|The study was closed prematurely due to slow accrual. When the study closed only two patients had died, making the OS 83%.|4 years|||percentage of participants|||Number
733825|NCT00413959|Primary|Overall Response Rate Using This Regimen in Patients With Low-grade B-Cell Non-Hodgkin's Lymphoma.|Percentage of complete responders plus percentage of partial responders equals overall response rate.|4 years|1 pt withdrew before completing two cycles and was not evaluable for OS.||percentage of patients|||Number
733826|NCT00413972|Primary|Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Endpoint After 8 Weeks of Treatment||Baseline, 8 weeks|The number of participants for analysis included those from the ITT data set. 392 subjects were randomized in the study, but 3 of the randomized subjects were not treated and were excluded from the ITT data set. Therefore, only 389 subjects were included in the ITT data set.||percent change of LDL-C||Standard Error|Mean
733827|NCT00414011|Primary|Corneal Epithelial Healing Time|patients' eyes will be observed daily after surgery until the corneal epithelium has completely healed (usually 3 to 4 days)|3 to 4 days after surgery|||days to complete epithelial healing|Participants|Full Range|Median
733828|NCT00414050|Secondary|Antibody to Hepatitis B Surface Antigen Geometric Mean Titer (Anti-HBs GMT) Responses for Modified Process Vaccine (5 μg and 10 μg), RECOMBIVAX™ Hepatitis B (Currently Licensed Vaccine), and ENGERIX-B®|Geometric Mean Titer - Antibody titer is a laboratory test that measures the presence and amount of antibodies in blood.|7 months of age (1 month after 3 doses)|Participants who follow the protocol, do not have major protocol deviations and have post-vaccination serology within specified day ranges.||mIU/mL||95% Confidence Interval|Geometric Mean
733862|NCT00422422|Primary|Mean Trough Plasma Concentration at 3rd Level for Age Range ≥12 to <16 Years||Day 21|||ug/mL||Standard Deviation|Mean
733863|NCT00422422|Primary|Mean Trough Plasma Concentration at 3rd Level for Age Range ≥2 to <12 Years||Day 21|||ug/mL||Standard Deviation|Mean
733864|NCT00422422|Primary|Mean Trough Plasma Concentration at 3rd Level for Age Range ≥1 Month to <2 Years||Day 21|||ug/mL||Standard Deviation|Mean
733829|NCT00414050|Primary|The Percentage of Seroresponders to the Modified Process Hepatitis B Vaccine (5 μg and 10 μg Dose), RECOMBIVAX HB™ Hepatitis B Vaccine (Currently Licensed Vaccine), and ENGERIX-B®|The percentage of participants as measured by Seroresponse. Seroresponse was defined as anti-hepatitis B surface antibodies greater than or equal to 10 milli-International Units (mIU)/mL. Success on the primary immunogenicity hypothesis required demonstrating an adequate anti-HBs seroprotection rate response for either modified process hepatitis B 5 μg vaccine or RECOMBIVAX HB™. Specifically, the lower bound of the multiplicity adjusted 95% confidence interval (CI) on the seroprotection rate for either vaccine was required to be above 90.0%.|7 months of age (1 month after 3 doses)|Participants who follow the protocol, do not have major protocol deviations and have post-vaccination serology within specified day ranges.||Percentage of participants||95% Confidence Interval|Number
733830|NCT00414167|Secondary|Percent BMI Loss|Percent loss in Body Mass Index|8 weeks (baseline and 8 weeks)|Baseline values imputed forward for missing data.||Percent loss||Standard Deviation|Mean
733831|NCT00414167|Primary|Frequency of Binge Eating Episodes||One week (at post treatment)|Baseline forward imputation for missing data.||episodes/week||Standard Deviation|Mean
733832|NCT00414206|Primary|Proportion of Subjects Losing Fewer Than 15 ETDRS Letters of Visual Acuity at 48 Weeks Compared to Baseline.||Baseline to Week 48|A modified MITT population was used, which was prospectively defined as all randomized patients who received at least one dose of study drug and had at least one post-baseline efficacy (visual acuity) assessment.||Percent of subjects|||Number
733833|NCT00414310|Secondary|Participant Response Durations/Length of Survival|The following scoring system used for patient outcomes: For a patient who died, his/her score is the actual number of weeks he/she survived since the beginning of treatment. For a patient who is still alive, his/her score is the number of weeks he/she has survived since the beginning of treatment plus a number which depends on his/her current status. Based on the median survival weeks in historical data, these numbers will be 40 for those patients who go off-study (resistant), 60 for patients without response but on study, 75 for patients with CRi or PR, and 110 for patients who have achieved CR.|1 Year or to disease progression||||||
733834|NCT00414310|Primary|Participant Response Rates to Decitabine With or Without Valproic Acid in MDS and AML|Complete Remission (CR): CR defined as normalization of peripheral blood and bone marrow with < 5% bone marrow blasts, a peripheral blood granulocyte count > (1.0 x 10^9/ L, and a platelet count > 100 x 10^9/L). CRi or complete remission with incomplete platelet recovery is defined as above, but platelets <100 x 109/L. Partial Remission: as above except for the presence of 6-15% marrow blasts, or 50% reduction if <15% at start of treatment. Clinical Benefit: In MDS/CMML, as per International Working Group (IWG) criteria, platelets increase by 50% and to above 30 x 10^9/L untransfused (if lower than that pretherapy); or granulocytes increase by 100% and to above 10^9/L (if lower than that pretherapy); or hemoglobin increase by 2 g/dl; or transfusion independent; or splenomegaly reduction by > 50%; or monocytosis reduction by > 50% if pretreatment > 5 x 10^9/L. In addition to IWG criteria, in AML, a decrease in bone marrow blasts to <5% also considered clinical benefit.|1 Year|One enrolled participant was not treated.||Percentage of Participants|||Number
733835|NCT00414388|Secondary|PSA -Biochemical Response|PSA Biochemical Response = PSA complete response + PSA partial response. A PSA complete response is defined as a non-detectable PSA (<4 ng/dl). A PSA partial response is defined as a PSA that decreases by greater than or equal to 50%.|1-10 months|||percentage of participants|||Number
733836|NCT00414388|Secondary|Overall Clinical Benefit (OCB)of This Combination as Calculated by the Sum of Complete Response (CR), Partial Response (PR), and Stable Disease (SD).|Assessment of response was done per Response Evaluation Criteria in Solid Tumors (RECIST) criteria as outlined in the protocol. Complete Response (CR) defined as disappearance of all measurable lesions. Partial Response (PR) more than 30% decrease in the sum of longest diameter of measurable lesions compared to baseline. Stable Disease (SD) lesions should have no sufficient decrease for PR any sufficient increase to meet criteria for PD. Progressive Disease (PD) more than 20% increase in the sum of longest diameter of measurable lesions compared to baseline, and/or evidence of new lesions on imaging studies or the appearance of 2 or more new bony lesions. For patient with measurable disease,prostate-specific antigen (PSA), progression in the absence of measurable disease progression will not be considered progressive disease. Overall Clinical Benefit (OCB) (CR + PR+ SD)/#participants.|3-10 months|||percentage of patients|||Number
733837|NCT00414388|Primary|Percentage of Patients Needing a Dose Reduction.|The actual percentage was determined by taking the number of patients requiring a dose reduction divided by the total number of patients multiplied by100%|participants were followed for an average of 25 months|15 patients required dose reductions.||percentage of participants|||Number
733838|NCT00414440|Secondary|Calculated GFR (mL/Min/1.73 m^2), Change From Baseline by Visit|Change in renal function was assessed by the Glomerular Filtration Rate (GFR) using the abbreviated (4 variables) Modification of Diet in Renal Disease (MDRD-4) formula which was developed by the MDRD Study Group and has been validated in patients with chronic kidney disease. The MDRD-4 formula used for the eGFR calculation is: eGFR (mL/min/1.73m^2) = 186.3*(C^-1.154)*(A^-0.203)*G*R, where C is the serum concentration of creatinine (mg/dL), A is age (years), G=0.742 when gender is female, otherwise G=1, R=1.21 when race is black, otherwise R=1. The changes in renal function were analyzed via analysis of covariance (ANCOVA) with treatment, pre-transplant hepatitis C virus status and randomization eGFR as covariates. Based on these ANCOVA analyses, the least-squares mean and standard errors of change were reported.|Months 3, 6, 9, 12, 18 and 24|ITT set, observed cases||mL/min/1.73m^2|Participants|Standard Deviation|Mean
733839|NCT00414440|Secondary|Changes in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Changes in systolic blood pressure (SBP) and diastolic blood pressure (DBP), at baseline and then months 12 and 24|Baseline, Months 12 and 24|ITT, observed cases||mmHG|Participants|Standard Deviation|Mean
733865|NCT00422448|Secondary|Frequency of NRAS Mutations Among Nevi|All nevi were analyzed for NRAS mutations using the (less sensitive) Sanger method. The (more sensitive) Ultradeep pyro-sequencing method (UDPS) is not applicable for this mutation. The frequency is reported here as the number of NRAS mutations from the analyzed nevi.|30 months|All nevi were analyzed for NRAS mutations using the (less sensitive) Sanger method. The (more sensitive) Ultradeep pyro-sequencing method (UDPS) is not applicable for this mutation. The frequency is reported here as the number of NRAS mutations from the analyzed nevi.||NRAS mutations|Participants||Number
733840|NCT00414440|Secondary|Calculated GFR, Change From Baseline at Month 60 by Baseline cGFR|Change in renal function was assessed by the estimated Glomerular Filtration Rate (eGFR) using the abbreviated (4 variables) Modification of Diet in Renal Disease (MDRD-4) formula which was developed by the MDRD Study Group and has been validated in patients with chronic kidney disease. The MDRD-4 formula used for the eGFR calculation is: eGFR (mL/min/1.73m^2) = 186.3*(C^-1.154)*(A^-0.203)*G*R, where C is the serum concentration of creatinine (mg/dL), A is age (years), G=0.742 when gender is female, otherwise G=1, R=1.21 when race is black, otherwise R=1. The changes in renal function were analyzed via analysis of covariance (ANCOVA) with treatment, pre-transplant hepatitis C virus status and randomization eGFR as covariates. Based on these ANCOVA analyses, the least-squares mean and standard errors of change were reported.|Months 24, 36, 48 and 60|ITT||mL/min/1.73 m^2||Standard Deviation|Mean
733841|NCT00414440|Secondary|Course of Calculated GFR (mL/Min/1.73 m^2) From Month 24 to Month 60|Course of calculated GFR (mL/min/1.73 m^2) at Months 24, 36, 48 and 60|Months 24, 36, 48 and 60|ITT||mL/min/1.73 m^2||Standard Deviation|Mean
733842|NCT00414440|Primary|Primary Efficacy Analysis of Total Kidney Volume (mITT Set, Multiple Imputation)|Everolimus (RAD001) compared to placebo with respect to the change from baseline in total kidney volume at Month 24.|Baseline, Month 24|mITT set||mL||95% Confidence Interval|Mean
733843|NCT00414453|Secondary|Kurtzke Expanded Disability Status Scale|Subject completes questionaire on functional status|Occurs at Visit 1|Data was not analyzed because we did not reach our enrollment goal and the study was terminated. Data was not analyzed because we the data is locked and is not available.|||||
733844|NCT00414453|Secondary|Patient Global Impression of Change Scale|Subject completes patient global impression questionaire of change scale|Occurs Visit 3, 4, 5|Data was not analyzed because we did not reach our enrollment goal and the study was terminated. Data was not analyzed because we the data is locked and is not available.|||||
733845|NCT00414453|Secondary|Short-Form McGill Pain Questionnaire|Subject completes short form McGill Pain questionaire|Occurs Visit 1, 3, 4 and 5|Data was not analyzed because we did not reach our enrollment goal and the study was terminated. Data was not analyzed because we the data is locked and is not available.|||||
733846|NCT00414453|Secondary|Short-form Health Survey 36 (SF-36)|Subject completes short form health survey 36 questionaire|Occurs at Visit 1, 3, 4 and 5|Data was not analyzed because we did not reach our enrollment goal and the study was terminated. Data was not analyzed because we the data is locked and is not available.|||||
733847|NCT00414453|Secondary|Beck Depression Inventory|Subject completes Beck questionaire|occurs at Visit 1, 3, 4 and 5|Data was not analyzed because we did not reach our enrollment goal and the study was terminated. Data was not analyzed because we the data is locked and is not available.|||||
733848|NCT00414453|Secondary|Daily Diary Sleep Interference Ratings|Subject identifies degree of sleep interference on a daily basis|daily|Data was not analyzed because we did not reach our enrollment goal and the study was terminated.. Data was not analyzed because we the data is locked and is not available.|||||
733849|NCT00414453|Secondary|Brief Pain Inventory Interference Items|subject completes the brief pain questionaire|occurs Visit 1, 3,4,5|Data was not analyzed because we did not reach our enrollment goal and the study was terminated. Data was not analyzed because we the data is locked and is not available.|||||
733850|NCT00414453|Secondary|Safety (i.e., Number of Serious Adverse Events)|Subject is asked about any adverse events that may have occurred since last contact; also subject can document any adverse events on daily pain diary scales|rating and review of any adverse events occurs at each visit|Data was not analyzed because we did not reach our enrollment goal and the study was terminated. Data was not analyzed because we the data is locked and is not available.|||||
733851|NCT00414453|Secondary|Tolerability (e.g., Number of Adverse Effects, Number of Drop-outs)|subject is questioned regarding any adverse events that have occured since the last contact; also subject can document any issues on daily pain rating diaries|rating of adverse events occur at each visit|Data was not analyzed because we did not reach our enrollment goal and the study was terminated. Data was not analyzed because we the data is locked and is not available.|||||
733852|NCT00414453|Primary|Mean Daily Diary Pain Ratings During Final Week of Each Treatment Period|subject identifies daily pain rating during final week of each treatment period using a numeric rating scale|Daily|Data was not analyzed because we the data is locked and is not available.|||||
733853|NCT00414466|Primary|Number of Participants With Treatment-emergent Adverse Events|Evaluation of adverse event profiles between placebo and active treatment groups.|Randomization to Post-randomization Day 29 (includes dose reduction)|All randomized subjects were included as per protocol.||Participants|||Number
733854|NCT00414466|Secondary|Responder Analysis Between Active Treatment and Placebo Groups.|Responders were subjects that reported at least a 30% decrease in average daily pain scores between baseline and Day 22.|Baseline to Post-randomization Day 22|All 170 randomized subjects were included as per protocol. Subjects experiencing an intolerable adverse event, discontinuing due to an adverse event or lack of efficacy, or not providing data were considered non-responders.||Participants|||Number
733855|NCT00414466|Primary|Changes in a Pain Rating Scale After 3 Weeks of Blinded Treatment.|Average pain score calculated over last 7 days of baseline minus average pain score calculated over last 7 days of follow-up using the Numeric Pain Rating Scale where 0=no pain, 10=worst possible pain.|Baseline and Post-randomization Day 22|Primary efficacy analysis was performed on the 167 randomized subjects that completed at least 4 days of the electronic pain diary during the last 7 days prior to the Day 22 or Early Termination Visit as per protocol. No imputation methods were used.||Scores on a scale||Standard Deviation|Mean
733856|NCT00422422|Secondary|Percent Compliance With Brivaracetam Oral Solution During the 3-week Evaluation Period||Baseline to the end of the 3-week evaluation period|Although 99 subjects were in the Safety Set and confirmed to have taken at least one dose of BRV, details on study drug intake were not able to be collected for 2 subjects. Therefore compliance could only be calculated for 97 subjects.||participants|||Number
733857|NCT00422422|Secondary|Number of Subjects With a 50 % Reduction in Seizures Based on Seizure Diary Data From Baseline to End of the 3-week Evaluation Period||Baseline to end of the 3-week evaluation period|||participants|||Number
733858|NCT00422422|Secondary|Number of Subjects With at Least One Treatment-emergent Adverse Event Reported During the 3-week Evaluation Period||Baseline to end of the 3-week evaluation period|||participants|||Number
733859|NCT00422422|Primary|Mean Max Plasma Concentration for Age Range ≥12 to <16 Years||Day 21|||ug/mL||Full Range|Mean
733866|NCT00422448|Primary|Frequency of BRAF Mutations Among Nevi|All nevi were analyzed for BRAF mutations using the (less sensitive) Sanger method. A random subset of nevi was also analyzed using the (more sensitive) Ultradeep pyro-sequencing method (UDPS). The frequency is reported here as the number of BRAF mutations found by each method.|up to 30 months|All nevi were analyzed for BRAF mutations using the (less sensitive) Sanger method. A random subset of nevi was also analyzed using the (more sensitive) Ultradeep pyro-sequencing method (UDPS). The frequency is reported here as the number of BRAF mutations found by each method.||BRAF mutations|Participants||Number
733867|NCT00422513|Secondary|The Number of Participants With Marked Laboratory Abnormalities Occurring in ≥5% of the Participants|A marked laboratory abnormality was defined as a test result that was outside of the marked abnormality range and that also represented a clinically relevant change from baseline of at least a designated amount.|Baseline, Month 1 to Month 7|Safety Population||number of participants|||Number
733868|NCT00422513|Secondary|Number of Participants Assessed for AEs|The adverse events are captured in the adverse event and serious adverse event section of this database.|Month 1 to 15 day follow up post month 7|Safety Population||number of participants|||Number
733869|NCT00422513|Primary|Change in Hemoglobin (Hb) Concentration From Baseline to the Average Over the Evaluation Period|Efficacy and pharmacoeconomics analyses were not performed.|Baseline, Months 5-7|The safety population was the anticipated population analyzed. Efficacy and pharmacoeconomics analyses were not performed.||g/dL|||Number
733870|NCT00422513|Primary|Time Spent on Anemia Treatment Over Evaluation Period|Efficacy and pharmacoeconomics analyses were not performed.|Months 5-7|The safety population was the anticipated population analyzed. Efficacy and pharmacoeconomics analyses were not performed.||months|||Number
733871|NCT00422656|Secondary|to Assess PFS and Duration of Response.||5 years||||||
733872|NCT00422656|Secondary|to Obtain Correlative Data in Patients With WM Treated With Perifosine||5 years||||||
733873|NCT00422656|Secondary|to Evaluate the Time to Progression in Patients With WM||5 years||||||
733874|NCT00422656|Secondary|To Evaluate the Toxicity of Perifosine in Patients With WM||1 year||||||
733875|NCT00422656|Primary|Response Rate Defined as Minimal, Partial or Complete Response in Patients With Relapsed or Refractory Waldenstrom’s Macroglobulinemia Receiving Daily Perifosine at 150mg Orally.|Participants will be formally evaluated for response after the second cycle and at each subsequent cycle using the criteria from the Second International Workshop on Waldenstrom's Macroglobulinemia. Response was determined through review of routine blood tests, serum protein electrophoresis with quantitative M-spike, quantitative IgM level, and serum free light chain as well as tumor measurements by CT scan and bone marrow aspirate/biopsy.|participants were followed for response for the duration of the study, approximately 2 years|Included all patients who received any treatment.||participants|||Number
733876|NCT00422669|Secondary|Clinical Event (Composite of Worsening of Heart Failure, Stroke or Death) Rate From Baseline to 2 Year Follow-up|Clinical event (composite of worsening of heart failure, stroke or death) rate from baseline to 2 year follow-up will be estimated and compared between the group of pacing at RV Mid-Septum and the group of pacing at Apex to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on clinical event(composite of worsening of heart failure, stroke or death)rate.|Baseline and 24 months|Data required for the analysis were not collected due to early study termination. Analysis will not be done.|||||
733877|NCT00422669|Secondary|Clinical Event (AT/AF Pnly or Composite of Worsening of Heart Failure, Stroke or Death) Rate From Baseline to Two Year Follow-up|Clinical event (AT/AF pnly or composite of worsening of heart failure, stroke or death) rate from baseline to two year follow-up will be estimated and compared between the group of pacing at RV Mid-Septum and the group of pacing at Apex to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on clinical event rate.|Baseline and 24 months|Data required for the analysis were not collected due to early study termination. Analysis will not be done.|||||
733878|NCT00422669|Secondary|The Change in Left Ventricular (LV) End Systolic Volume (Diastolic Volume) After Two Years Follow-up|LV end systolic volume (diastolic volume)will be measured at baseline and 2 year follow-up for the group of pacing at RV Mid-Septum and the group of pacing at Apex. The change in LV end systolic volume (diastolic volume)from two week visit to 2 year follow-up will be compared between two groups to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on the change in LV end systolic volume (diastolic volume).|Baseline and 24 months|Data required for the analysis were not collected due to early study termination. Analysis will not be done.|||||
733879|NCT00422669|Secondary|The Change in Six-minute Hall Walk Distance|The change in six-minute hall walk distance will be measured at two week visit and 2 year follow-up for the group of pacing at RV Mid-Septum and the group of pacing at Apex. The change in six-minute hall walk distance will be compared between two groups to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on the change in six-minute hall walk distance.|Baseline and 24 months|Data required for the analysis were not collected due to early study termination. Analysis will not be done.|||||
733880|NCT00422669|Secondary|The Change in LVEF From Two Week Visit to Two Year Follow-up|Left ventricular ejection fraction (LVEF) will be measured at two week visit and 2 year follow-up for the group of pacing at RV Mid-Septum and the group of pacing at Apex. The change in LVEF from two week visit to 2 year follow-up will be compared between two groups to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on the change in LVEF.|Baseline and 24 months|Data required for the analysis were not collected due to early study termination. Analysis will not be done.|||||
733881|NCT00422669|Primary|The Change in Left Ventricular (LV) Ejection Fraction From Baseline to Two Year Follow-up|Left ventricular ejection fraction (LVEF) will be measured at baseline and two year follow-up for the group of pacing at RV Mid-Septum and the group of pacing at Apex. The change in LVEF from baseline to two year follow-up will be compared between two groups to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on the change in LVEF.|Baseline and 24 months|Data required for the analysis were not collected due to early study termination. Analysis will not be done.|||||
734287|NCT00425308|Secondary|Change in Renal Function Assessed by Proteinuria at Month 3, Month 6 and Month 12|Change in proteinuria (g/24h) from baseline to M12|From Baseline to Month 3, 6, and 12|Intent to Treat Population||g/24h||Standard Deviation|Mean
733882|NCT00422695|Primary|Spontaneous Pain Intensity|"Pain intensity as measured with Visual Analog Scale during the time of examination.
The subjects were required to report their perceived level of pain on a 10 cm VAS scale from zero to 10 with zero being no pain and 10 representing the worst pain imaginable. Given the ease of use of this method and its current use to measure pain, VAS scales were adapted to measure patient perceived orofacial pain wherein subjects were asked to draw a vertical line at the point on the horizontal line which best represented their pain response. Where left 0 is no pain and right -10 is maximal pain."|The time of the examination|Comparison was made between control and HIV+ subjects||units on a scale (0 to 10)||Standard Deviation|Mean
733883|NCT00422695|Primary|Number of Participants With Chronic Myogenic Pain, TMJ Disoder, and Burning Mouth Syndrome|"To investigate the prevalence of orofacial pain in HIV infected patients during routine dental clinical assessment.
To study the sensory phenotype of HIV+ patients and healthy volunteers using Quantitative Sensory Testing:
To detect the presence of sensory aberrations in the orofacial complex;
To identify which nerve types are involved;
To identify the type of orofacial pain based on both sensory testing and clinical findings.
3.To determine psychological condition and nutrition status in patients with HIV.
4.To find associations between inherited traits and development of neuropathic pain."|Tests were performed during regular clinical visit. The test duration was about an hour|Comparisons of categorical variables were performed with Fischer’s exact test. Trends in ordered categorical variables were tested with the chi square test.||Participants|||Number
733884|NCT00422734|Secondary|Change From Baseline to 12 Week Endpoint in the Self-Esteem and Relationship (SEAR) Questionnaire - Confidence Domain Subscales|Measures improvement in confidence (items 9-14). Confidence domain consists of two subscales (Self-Esteem, items 9–12; Overall Relationship, items 13 and 14). Each domain score, subscale score, and overall score are transformed onto a 0 (least favorable) to 100 (most favorable) scale.|Baseline and 12 weeks|last observation carried forward for all randomized participants having both baseline and at least one post-baseline data measurement||units on a scale||Standard Error|Least Squares Mean
733885|NCT00422734|Secondary|Change From Baseline to 12 Week Endpoint in the Self-Esteem and Relationship (SEAR) Questionnaire|Measures improvement in self-esteem and relationship satisfaction. Questionnaire consists of two domains, Sexual Relationship (items 1–8) and Confidence (items 9–14). Overall score is transformed onto a 0 (least favorable) to 100 (most favorable) scale. Overall score was calculated from two domains and subscales scores.|Baseline and 12 weeks|last observation carried forward for all randomized participants having both baseline and at least one post-baseline data measurement||units on a scale||Standard Error|Least Squares Mean
733886|NCT00422734|Secondary|"Change From Baseline to 12 Week Endpoint in Percent of Yes Responses to Partner-Sexual Encounter Profile (SEP) Questions 1 and 2 - Partner Response"|The baseline and endpoint score for each SEP question 1 (Achieve some erection) and 2 (Insert penis into vagina) are the partner’s percentage of “yes” responses to those questions during the run-in period and postbaseline period, respectively.|Baseline and 12 weeks|all randomized participants having both baseline and at least one post-baseline data measurement||percent||Standard Error|Least Squares Mean
733887|NCT00422734|Secondary|"Percent of Partners With Yes Responses to Global Assessment Questionnaire (GAQ) - Partner Response"|"Percent of Partners with Yes responses to Question 1 (Improvement in Erections) and Question 2 (Improvement in the Ability to Engage in Sexual Activity)"|12 weeks|all randomized participants having post-baseline data measurement on this variable||percentage of partners answering Yes|||Number
733888|NCT00422734|Secondary|"Percent of Subjects With Yes Responses to Global Assessment Questionnaire (GAQ) - Subject Response"|"Percent of subjects with Yes responses to Question 1 (Improvement in Erections) and Question 2 (Improvement in the Ability to Engage in Sexual Activity)"|12 weeks|all randomized participants having post-baseline data measurement on this variable||percentage of subjects answering Yes|||Number
733889|NCT00422734|Secondary|Change From Baseline to 12 Week Endpoint in the Satisfaction Domain of the Female Sexual Function Index (FSFI) - Partner Response|The FSFI Satisfaction Domain (items 14-16) measures satisfaction with emotional closeness, sexual relationship, and overall sexual life. Each question is scored on a 0/1 to 5 scale and domain score is calculated by multiplying the total points by 0.4, for a total score range of 0.8 to 6, with higher scores indicating greater satisfaction.|Baseline and 12 weeks|last observation carried forward for all randomized participants having both baseline and at least one post-baseline data measurement||units on a scale||Standard Error|Least Squares Mean
733890|NCT00422734|Secondary|"Change From Baseline to 12 Week Endpoint in Percent of Yes Responses to Partner-Sexual Encounter Profile (SEP) Question 3 - Partner Response"|The baseline and endpoint score for partner SEP question 3 (Satisfied overall) are the partner's percentage of “yes” responses to the question during the run-in period and postbaseline period, respectively.|Baseline and 12 weeks|all randomized participants having both baseline and at least one post-baseline data measurement||percent||Standard Error|Least Squares Mean
733891|NCT00422734|Secondary|"Change From Baseline to 12 Week Endpoint in Percent of Yes Responses to Sexual Encounter Profile (SEP) Questions 4 and 5 - Subject Response"|The baseline and endpoint score for each SEP question 4 (Satisfied with hardness) and 5 (Satisfied overall) are the subject’s percentage of “yes” responses to those questions during the run-in period and postbaseline period, respectively.|Baseline and 12 weeks|all randomized participants having both baseline and at least one post-baseline data measurement||percent||Standard Error|Least Squares Mean
733892|NCT00422734|Primary|"Change From Baseline to Endpoint in the Percent of Yes Responses to Sexual Encounter Profile (SEP) Diary Questions 2 (SEP2) and 3 (SEP3)."|The baseline and endpoint score for each SEP question 2 (Insert penis into vagina) and 3 (Successful intercourse) are the subject’s percentage of “yes” responses to those questions during the run-in period and postbaseline period, respectively.|Baseline and 12 weeks|all randomized participants having both baseline and at least one post-baseline data measurement||percent||Standard Error|Least Squares Mean
733893|NCT00422734|Secondary|Sexual Life Quality Questionnaire (SLQQ) Treatment Satisfaction Domain|The 6 SLQQ-treatment satisfaction questions were answered by subject and partner at Visit 4/Final Visit. Original item scores (1 to 6 range) were converted to 0 to 5 scale by subtracting 1 to each recorded responses. Each transformed score was multiplied by 20. Total range of scores: 0 (low satisfaction) to 100 (high satisfaction).|12 weeks|all randomized participants having post-baseline data measurement on this variable||units on a scale||Standard Error|Least Squares Mean
733894|NCT00422734|Secondary|Change From Baseline to 12 Week Endpoint in Overall Satisfaction Domain of the International Index of Erectile Function (IIEF-OS) - Subject Response|Self-reported overall satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 2 questions of the IIEF-OS domain range from 0 to 10.|Baseline and 12 weeks|last observation carried forward for all randomized participants having both baseline and at least one post-baseline data measurement||units on a scale||Standard Error|Least Squares Mean
733895|NCT00422734|Secondary|Change From Baseline to Week 12 Endpoint in the International Index of Erectile Function - Intercourse Satisfaction Domain - Subject Response|Self-reported intercourse satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 3 questions of the IIEF-IS domain range from 0 to 15.|Baseline and 12 weeks|last observation carried forward for all randomized participants having both baseline and at least one post-baseline data measurement||units on a scale||Standard Error|Least Squares Mean
733896|NCT00422734|Primary|Improvement in the Sexual Quality of Life in the Subject and His Study Partner as Measured by the Sexual Quality of Life (SQoL) Domain of the Sexual Life Quality Questionnaire (SLQQ)|The original item scores (-4 to 4 range) were converted to 0 to 8 scale score by adding 4 to each recorded responses. Each transformed score was multiplied by 12.5 for a total range of 0 to 100. Higher scores are indicative of a higher sexual quality of life.|Baseline and 12 weeks|last observation carried forward for all randomized participants having both baseline and at least one post-baseline data measurement||units on a scale||Standard Error|Least Squares Mean
733897|NCT00422734|Primary|Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF)- Erectile Function Domain Score (Sum of IIEF Questions 1-5 and 15)|Measures erectile function over the past 4 weeks on Questions 1-5 and 15 (6 questions) of the International Index of Erecile Function (IIEF) questionnaire. Scores range from 0 (low/no erectile function) to 5 (high erectile function), thus the 6 questions of the IIEF-EF domain range from 0 to 30.|Baseline and 12 weeks|last observation carried forward for all randomized participants having both baseline and at least one post-baseline data measurement||units on a scale||Standard Error|Least Squares Mean
733898|NCT00423852|Primary|Maximum Tolerated Dose of Ifosfamide||4 years|||mg/m2|||Number
733899|NCT00423852|Primary|Response|"Response assessed at the completion of therapy (after four to five cycles of chemotherapy and after surgery if necessary)
Complete Response (CR): A complete response is defined as one of the following:
Complete disappearance of all clinical and radiographic and biochemical (normal AFP and HCG) evidence of disease for a minimum of 4 weeks (CR to chemotherapy).
Complete disappearance of all biochemical evidence of disease with resection of residual radiographic masses that prove to be negative for residual GCT; this includes both mature teratoma and necrotic debris (CR to chemotherapy) for a minimum of 4 weeks.
Complete disappearance of all biochemical evidence of disease with complete surgical excision of all residual radiographic masses that, if pathologically positive for residual malignant GCT, show margins to microscopically free of disease (CR to chemotherapy + surgery). Patients must be free of disease for a minimum of 4 weeks."|2 year|||participants|||Number
733900|NCT00423878|Secondary|Efficacy Failure, Defined as Psychiatric Hospitalization, a 25 Percent Increase From Baseline on the Positive and Negative Syndrome Scale or Substantial Clinical Deterioration on the Clinical Global Impressions-Change (CGI-C)||Measured at Month 6|2 participants who never took assigned study medication were excluded.||participants|||Number
733901|NCT00423878|Primary|Change in Non-HDL Cholesterol Level for Patients Assigned to Stay and Patients Assigned to Switch Over 24 Weeks|Change in non-HDL cholesterol measured at baseline and every 4 weeks for 24 weeks. The efficacy analysis corresponded to a comparison of change in non-HDL cholesterol from baseline to 24 weeks between treatment groups (stay versus switch). Repeated measurements mixed effects linear models were fit for the primary analysis.|24 weeks|The primary efficacy analysis was conducted on the efficacy evaluable population, defined as all patients randomly assigned to a study group who received at least one dose of study medication and completed at least one post-baseline efficacy assessment.||mg/dL non-HDL cholesterol||Standard Error|Least Squares Mean
733902|NCT00423891|Secondary|Number of Participants With Electrolyte Laboratory Abnormalities (Grades 1 - 4) - On Treatment - Treated Participants|Toxicity Scale: DAIDS Version 1.0 and modified World Health Organization (WHO) for chloride. Milliequivalents per liter (mEq/L); Grade (Gr). Chloride high (mEq/L): Gr1: 113-<117; Gr2: 117-<121; Gr3: 121-125; Gr4: >125. Potassium low (mEq/L): Gr1: 3.0-3.4; Gr2: 2.5-2.9; Gr3:2.0-<2.4; Gr4: <2.0. Potassium high: Gr1; 5.6- <6.0; Gr2: 6.1-<6.5; Gr3: 6.6-7.0; Gr4: >7.0. Sodium high (mEq/L): Gr1; 146-<150; Gr2: 151-<154; Gr3: 155-<159; Gr4: >=160.|Day 1 Week 120|Participants who received at least one dose of study drug, and had a measurement during the on-treatment period (i.e., after the first day of study therapy through 5 days after the last dose of study therapy).||participants|||Number
733903|NCT00423891|Secondary|Number of Participants With Chemistry Laboratory Abnormalities (Grades 1 - 4) - On Treatment - Treated Participants|Toxicity Scale: DAIDS Version 1.0 and modified World Health Organization (WHO). Grade (Gr). ALT: Gr1:1.25-<2.5*ULN; Gr2: 2.6-<5.0 *ULN; Gr3: 5.1-10.0*ULN; Gr4:>10.0*ULN. Aspartate aminotransferase (AST): Gr1: 1.25-<2.5*ULN; Gr2:2.6-<5.0*ULN; Gr 3: 5.1-10.0*ULN; Gr4>10.0*ULN. Alkaline phosphatase: Gr1:1.25-<2.5*ULN; Gr2: 2.6-<5.0*ULN; Gr3: 5.1-10.0*ULN; Gr4: >10.0*ULN. Lipase: Gr1:1.1-<1.5*ULN;Gr2:1.6-<3.0*ULN; Gr3: 3.1-5.0*ULN; Gr4: >5.0*ULN. Creatinine: Gr1: 1.1-1.3*ULN; Gr2: 1.4-<1.8*ULN; Gr3: 1.9 - <3.4*ULN; Gr4: >=3.5*ULN. Glucose mg/dL (high): Gr1:110-<125 (Fasting)/116-<160;Gr2:126-<250 (F)/161-<250; Gr3: 251-500; Gr4: >500.Glucose (low): Gr1: 55-64; Gr2: 40 - <54; Gr3: 30-39; Gr4: <30 mg/dL.|Day 1 to Week 120|Participants who received at least one dose of study drug, and had a measurement during the on-treatment period (i.e., after the first day of study therapy through 5 days after the last dose of study therapy).||participants|||Number
733904|NCT00423891|Secondary|Number of Participants With Hematology Laboratory Abnormalities (Grades 1 - 4) - On Treatment - Treated Participants|Toxicity Scale: Division of AIDs (DAIDS) grades Version 1.0. Upper limit of normal (ULN); lower limit of normal (LLN); Cells per Liter (c/L); cells per microliter (c/µL); grams per deciliter (g/dL); milliequivalents per liter (mEq/L); cells per microliter (c/µL): Grade (Gr). Hemoglobin g/dL: Gr1:10.0-10.9;Gr2: 9.0-9.9; Gr3:7.0-8.9; Gr4: <7.0. International normalization ratio (INR): Gr1:1.1-<1.5*ULN; Gr2: 1.6-<2.0*ULN; Gr3: 2.1-3.0*ULN;Gr4: >3.0*ULN. Neutrophils/bands c/µL: Gr1;1.0-1.3*10^3; Gr2: 0.75-0.99*10^3; Gr 3: 0.50-0.749*10^3; Gr4: <0.5*10^3.|Day 1 to Week 120|Participants who received at least 1 dose of study therapy, and had a measurement during the on-treatment period (i.e., after the first day of study therapy through 5 days after the last dose of study therapy).||participants|||Number
733905|NCT00423891|Secondary|Number of Participants With a Combination of ALT Normalization and HBV DNA Less Than 50 IU/mL, Without HBeAg Seroconversion, Through Week 48 (Non-Completer=Failure) in Treated Participants|Hepatitis B virus DNA by PCR was measured using the Roche COBAS TaqMan - HPS assay and was reported in IU/mL. Baseline was the last value measured prior to or on the date of the first dose of study therapy. Normalization in ALT= ALT ≤ 1.0*ULN. HBe seroconversion: loss of HBeAg (HBeAg negative) with positive HBeAb. The method used for the detection of HBeAg/Ab serologies was the DiaSorin enzyme immunoassay kit.|Baseline to Week 48|The intent-to-treat method of Non-Completer = Failure was used in which the number of participants analyzed was all treated participants, and participants who had missing data at the analysis week were considered failures.||participants|||Number
733906|NCT00423891|Secondary|Number of Participants With a Combination of ALT Normalization and HBV DNA Less Than 50 IU/mL, Plus HBeAg Seroconversion Through Week 48 (Non-Completer=Failure) in Treated Participants|Hepatitis B virus DNA by PCR was measured using the Roche COBAS TaqMan - HPS assay and was reported in IU/mL. Baseline was the last value measured prior to or on the date of the first dose of study therapy. Normalization in ALT= ALT ≤ 1.0*ULN. HBe seroconversion was determination of presence of HBeAb and loss of HBeAg. The method used for the detection of HBeAg seroconversion was the DiaSorin - Anti HBe enzyme immunoassay kit.|Baseline to Week 48|The intent-to-treat method of Non-Completer = Failure was used in which the number of participants analyzed was all treated participants, and participants who had missing data at the analysis week were considered failures.||participants|||Number
733907|NCT00423891|Secondary|Number of Participants With a Combination of ALT Normalization and HBV DNA Less Than 50 IU/mL Through Week 48 (Non-Completer=Failure) in Treated Participants|Hepatitis B virus DNA by PCR was measured using the Roche COBAS TaqMan - HPS assay and was reported in IU/mL. Baseline was the last value measured prior to or on the date of the first dose of study therapy. Normalization in ALT= ALT ≤ 1.0*ULN.|Baseline to Week 48|The intent-to-treat method of Non-Completer = Failure was used in which the number of participants analyzed was all treated participants, and participants who had missing data at the analysis week were considered failures.||participants|||Number
733908|NCT00423891|Secondary|Number of Participants With HBV DNA by PCR Categories (Non-Completer=Failure) at Week 48 in Treated Participants|Hepatitis B virus DNA by PCR was measured using the Roche COBAS TaqMan - HPS assay and was reported in IU/mL. LLQ = 29 IU/mL. Baseline was the last value measured prior to or on the date of the first dose of study therapy.|Baseline, Week 48|The intent-to-treat method of Non-Completer = Failure was used in which the number of participants analyzed was all treated participants, and participants who had missing data at the analysis week were considered failures.||participants|||Number
733909|NCT00423891|Secondary|Alanine Aminotransferase (ALT) Normalization From Baseline Through Week 48 (Non-Completer=Failure) in Treated Participants|Normalization in ALT= ALT ≤ 1.0*upper limit of normal (ULN). Baseline was the last value measured prior to or on the date of the first dose of study therapy.|Baseline to Week 48|The intent-to-treat method of Non-Completer = Failure was used in which the number of participants analyzed was all treated participants, and participants who had missing data at the analysis week were considered failures.||participants|||Number
733910|NCT00423891|Secondary|Mean Log10 Change From Baseline in HBV DNA Using Roche COBAS TaqMan - HPS Through Week 48 in Treated Participants|Hepatitis B virus DNA by PCR was measured using the Roche COBAS TaqMan - HPS assay and was reported in IU/mL. HBV DNA log10 changes from baseline were summarized over time.|Baseline to Week 48|Participants who received at least one dose of study drug, and had a measurement at baseline and at the specific analysis week.||IU/mL||Standard Error|Mean
733911|NCT00423891|Secondary|Number of Participants Who Had a Protocol Defined Response (PDR) Through Week 48 (Non-Completer=Failure) in Treated Participants|PDR was defined as confirmed HBV DNA < 50 IU/mL plus confirmed HBeAg seroconversion on 2 sequential measurements at least 14 days apart. Baseline was the last value measured prior to or on the date of the first dose of study therapy.|Baseline to Week 48|The intent-to-treat method of Non-Completer = Failure was used in which the number of participants analyzed was all treated participants, and participants who had missing data at the analysis week were considered failures.||participants|||Number
733912|NCT00423891|Secondary|Number of Participants With HB s Antigen (HBsAg) Seroconversion Through Week 48 (Non-Completer=Failure) in Treated Participants|HB s Ag seroconversion: loss of HBsAg (HBsAg negative) and presence of HB s antibodies (HBsAb). The method used for the detection of HBsAg seroconversion was the ADVIA Centaur iImmunoassay system. Baseline was the last value measured prior to or on the date of the first dose of study therapy.|Baseline through Week 48|The intent-to-treat method of Non-Completer = Failure was used in which the number of participants analyzed was all treated participants, and participants who had missing data at the analysis week were considered failures.||participants|||Number
733913|NCT00423891|Secondary|Number of Participants With HBV DNA Less Than Lower Limit of Quantification (LLQ) for the Roche COBAS TaqMan - HPS Assay (Non-Completer=Failure) Through Week 48 in Treated Participants|Hepatitis B virus DNA by PCR was measured using the Roche COBAS TaqMan - HPS assay and was reported in IU/mL. LLQ = 29 IU/mL. Baseline was the last value measured prior to or on the date of the first dose of study therapy.|Baseline through Week 48|The intent-to-treat method of Non-Completer = Failure was used in which the number of participants analyzed was all treated participants, and participants who had missing data at the analysis week were considered failures.||participants|||Number
733914|NCT00423891|Secondary|Number of Participants With HBV DNA Less Than Lower Limit of Detection (LLD) for the Roche COBAS TaqMan - HPS Assay (Non-Completer=Failure) at Week 48 in Treated Participants|Hepatitis B virus DNA by PCR was measured using the Roche COBAS TaqMan - HPS assay and was reported in IU/mL. LLD = 6 IU/mL). Baseline was the last value measured prior to or on the date of the first dose of study therapy.|Baseline to Week 48|The intent-to-treat method of Non-Completer = Failure was used in which the number of participants analyzed was all treated participants, and participants who had missing data at the analysis week were considered failures.||participants|||Number
733935|NCT00423943|Primary|Gamma Power Change in Count of Clusters|Power in Gamma frequency range by scalp electrophysiology after single-dose and after 4-week treatment: Count of Clusters (defined as those with statistically-significant Task-Related Increase, i.e. relatively larger value of wavelet coefficient in wavelet analysis of signal) for high-control (i.e. difficult) condition versus Low-control (i.e. easy) condition, in Oscillatory Power in Time-Frequency Spectrogram. Increased values indicate improved function.|4 weeks|2 subjects in the Drug arm refused to perform EEG.||Count of Positive Power Clusters||Standard Deviation|Mean
733915|NCT00423891|Primary|Number of Participants With Serious Adverse Events (SAE) and Discontinuations Due to Adverse Events (AEs) - On Treatment|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Medical Dictionary for Regulatory Activities (MedDRA) version 16.0 was used.|Day 1 to Week 120|All participants who received at least one dose of study drug. On-treatment period began on the first day of study therapy and ended 5 days after the last dose of study therapy.||participants|||Number
733916|NCT00423891|Secondary|Number of Participants With Hepatitis B e Antigen Seroconversion Through Week 48 (Non-Completer=Failure) in Treated Participants|HBe seroconversion: loss of HBeAg (HBeAg negative) with positive HB e antibodies (HBeAb), ie both the presence of HBeAb and the absence of HBeAg. The method used for the detection HBeAg seroconversion was the DiaSorin - Anti HBe enzyme immunoassay kit. Baseline was the last value measured prior to or on the date of the first dose of study therapy.|Baseline through Week 48|The intent-to-treat method of Non-Completer = Failure was used in which the number of participants analyzed was all treated participants, and participants who had missing data at the analysis week were considered failures.||participants|||Number
733917|NCT00423891|Secondary|Number of Participants With Hepatitis B s Antigen (HBsAg) Loss Through Week 48 (Non-Completer=Failure) in Treated Participants|HBsAg loss: HBsAg negative. The method used for detection of HBsAg was the ADVIA Centaur iImmunoassay system. Baseline was the last value measured prior to or on the date of the first dose of study therapy.|Baseline to Week 48|The intent-to-treat method of Non-Completer = Failure was used in which the number of participants analyzed was all treated participants, and participants who had missing data at the analysis week were considered failures.||participants|||Number
733918|NCT00423891|Secondary|Number of Participants With Hepatitis B e Antigen (HBeAg) Loss Through Week 48 (Non-Completer=Failure) in Treated Participants|HBeAg loss: HBeAg negative. The method used for the detection of HBe Ag was the DiaSorin - Anti HBe enzyme immunoassay kit. Baseline was the last value measured prior to or on the date of the first dose of study therapy.|Baseline to Week 48|The intent-to-treat method of Non-Completer = Failure was used in which the number of participants analyzed was all treated participants, and participants who had missing data at the analysis week were considered failures.||participants|||Number
733919|NCT00423891|Secondary|Number of Participants With HBV DNA Less Than 50 IU/mL Through Week 48 (Non-Completer=Failure) in Treated Participants|Hepatitis B virus DNA by polymerase chain reaction (PCR) was measured using the Roche COBAS TaqMan - high pure system (HPS) assay and was reported in international units per milliliter (IU/mL). Baseline was the last value measured prior to or on the date of the first dose of study therapy.|Baseline to Week 48|The intent-to-treat method of Non-Completer = Failure was used in which the number of participants analyzed was all treated participants, and participants who had missing data at the analysis week were considered failures.||participants|||Number
733920|NCT00423891|Primary|Mean Apparent Total Body Clearance (CLT/F) of Entecavir in LVD-naive and LVD-experienced Participants, by Age Cohort|CLT/F was calculated by dividing the dose of ETV by AUC(TAU) of ETV and was measured in liters per hour (L/h). Blood samples were obtained before study drug administration and at 0.5, 1, 2, 4, 8, and 24 hours after study drug administration on Day 14 (+/- 4 days) for the PK assessment. Plasma samples were analyzed for ETV with a validated method using liquid chromatography-tandem mass spectrometry detection. PK assessment was optional for Group C participants (NA-experienced participants who were included with the September 2011 country-specific protocol amendment). No Group C participants chose to participate in the PK assessment.|At 2 weeks|Participants in Groups A and B who received study drug and had PK assessment.||L/h||Standard Deviation|Mean
733921|NCT00423891|Primary|Mean Area Under the Concentration-Time Curve in One Dosing Interval [AUC(TAU)] of Entecavir in LVD-naive and LVD-experienced Participants, by Age Cohort|Area under the Curve (AUC) was derived from plasma concentration of ETV versus time. AUC(TAU) was calculated by log- and linear trapezoidal summations, TAU = 24 hours, and was measured in nanograms*hours per milliliter (ng*h/mL). Blood samples were obtained before study drug administration and at 0.5, 1, 2, 4, 8, and 24 hours after study drug administration on Day 14 (+/- 4 days) for the PK assessment. Plasma samples were analyzed for ETV with a validated method using liquid chromatography-tandem mass spectrometry detection. PK assessment was optional for Group C participants (NA-experienced participants who were included with the September 2011 country-specific protocol amendment). No Group C participants chose to participate in the PK assessment.|Day 14|Participants in Groups A and B who received study drug and had PK assessment.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
733922|NCT00423891|Primary|Median Time of Maximum Observed Plasma Concentration (Tmax) in LVD-naive and LVD-experienced Participants, by Age Cohort|Tmax was derived from plasma concentration of ETV versus time and measured in hours (h). Blood samples were obtained before study drug administration and at 0.5, 1, 2, 4, 8, and 24 hours after study drug administration on Day 14 (+/- 4 days) for the PK assessment. Plasma samples were analyzed for ETV with a validated method using liquid chromatography-tandem mass spectrometry detection. Age categories presented below: participants age as of first day of dosing. PK assessment was optional for Group C participants (NA-experienced participants who were included with the September 2011 country-specific protocol amendment). No Group C participants chose to participate in the PK assessment.|Day 14|Participants in Groups A and B who received study drug and had PK assessment.||h||Full Range|Median
733923|NCT00423891|Primary|Mean Maximum Observed Plasma Concentration (Cmax) and Mean Trough Observed Plasma Concentration (Cmin) of Entecavir in LVD-naive and LVD-experienced Participants, by Age Cohort|Cmax and Cmin were derived from plasma concentration of ETV versus time and measured in nanograms per milliliters (ng/mL). Blood samples were obtained before study drug administration and at 0.5, 1, 2, 4, 8, and 24 hours after study drug administration on Day 14 (+/- 4 days) for the PK assessment. Plasma samples were analyzed for ETV with a validated method using liquid chromatography-tandem mass spectrometry detection. Note: PK parameters were summarized for only Groups A and B. PK assessment was optional for Group C participants (NA-experienced participants who were included with the September 2011 country-specific protocol amendment). No Group C participants chose to participate in the PK assessment.|Day 14|Participants in Groups A and B who received study drug and had PK assessment.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
733924|NCT00423917|Secondary|Duration of Response/Time to Disease Progression in Patients With Measurable Disease|Duration of response is defined for all evaluable patients with measurable disease who have achieved a confirmed response as the date at which the patient’s earliest best objective status is first noted to be either a CR or PR to the earliest date progression is documented. If a patient dies subsequent to the confirmed response without a documentation of disease progression, the patient will be considered to have had disease progression at the time of their death. In the case of a patient failing to return for evaluations before a documentation of disease progression, the patient will be censored for progression on the date of last evaluation. The distribution of duration of response will be estimated using the method of Kaplan-Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Up to 5 years|Evaluable patients with measurable disease who experienced a confirmed response.||months||95% Confidence Interval|Median
733925|NCT00423917|Secondary|Time to First Cytotoxic Agent|Time to first dose of a cytotoxic agent is defined to be the time from the date of registration to the date at which a patient recieves the first dose of a cytotoxic agent. The distribution of time to first dose of a cytotoxic agent will be estimated using the method of Kaplan-Meier (1958).|Up to 5 years|||months||95% Confidence Interval|Median
733926|NCT00423917|Secondary|Objective Response Rate as Measured by RECIST Criteria in Patients With Measurable Disease|A confirmed response is defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart. The confirmed response rate will be estimated by the number of confirmed responses in evaluable patients with measurable disease divided by the total number of evaluable patients with measurable disease. The appropriate confidence interval will be calculated. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 5 years|||percentage of patients||95% Confidence Interval|Number
733927|NCT00423917|Secondary|Quality of Life, as Measured by the Largest Mean Change in LASA Overall QOL and Physical Well-being Items|Quality of life (QOL) assessment will be a secondary exploratory component of this trial. QOL of patients was measure using the 6-item Linear Analogue Self-Assessment (LASA).The LASA consists of six single-item numeric analog scales measuring overall QOL; mental, physical, emotional, and spiritual well-being; and level of activity each on a scale of 0 ('As bad as it can be') to 10 ('As good as it can be') during the past week. Items were transformed to a 0 (worst QOL or well-being) to 100 (best QOL or well-being) scale for statistical analysis. Mean change from baseline of the largest mean change in overall QOL and physical well-being are reported below.|Up to 5 years|||mean change in LASA QOL scaled score||Standard Deviation|Mean
733928|NCT00423917|Secondary|Overall Survival|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier (1958).|Up to 5 years|||months||95% Confidence Interval|Median
733929|NCT00423917|Secondary|Progression Free Survival|Time to disease progression is defined as the time from registration to the earliest date of documentation of disease progression. If a patient dies without a documentation of disease progression the patient will be considered to have had disease progression at the time of their death. If the patient is declared to be a major treatment violation, the patient will be censored on the date the treatment violation was declared to have occurred. In the case of a patient starting treatment and then never returning for any evaluations, the patient will be censored for progression 1 day post-registration. The distribution of time to progression will be estimated using the method of Kaplan-Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Up to 5 years|||months||95% Confidence Interval|Median
733930|NCT00423917|Primary|Six-month Progression-free Survival (PFS) Rate at 6 Months|The primary endpoint of this trial is the 6-month progression-free survival rate. A patient is considered to be a 6-month progression-free survivor if the patient is on study treatment 6 months from registration without a documentation of disease progression. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Additionally, if some patients are lost to follow-up not having been observed for at least 6 months, an estimate and 95% confidence interval for the 6-month progression-free survival rate incorporating censoring will be computed using the method of Kaplan-Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|at 6 months|||percentage of patients||95% Confidence Interval|Number
733931|NCT00423930|Secondary|Overall Survival Rate: Percentage of Participants Who Survived||2 years|||percentage of participants||95% Confidence Interval|Number
733932|NCT00423930|Primary|Progression-free Survival at 2 Years|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Percentage of Participants Experiencing Progression-free Survival at 2 Years|||percentage of participants||95% Confidence Interval|Number
733933|NCT00423943|Secondary|Change in Negative Symptoms|Change in average score, ranging from 0 (absent) to 5 (severe), on on Scale for the Assessment of Negative Symptoms (SANS) from baseline to 4-week time-point. Decreased values indicate improved clinical status (lesser symptom severity).|Baseline, 4 weeks|||units on SANS scale||Standard Deviation|Mean
733934|NCT00423943|Secondary|Change in Positive Symptoms|Change in Average score (range 0-5) on the Scale for Assessment of Positive Symptoms (SAPS) from baseline to 4 week time-point, ranging from 0 (absent) to 5 (severe). Decreased values indicate improved clinical status (lesser symptom severity).|Baseline, 4 weeks|||units on a scale||Standard Deviation|Mean
733936|NCT00423943|Primary|Control-related BOLD Signal Change in Locus Coeruleus|BOLD signal change on high-control (i.e. difficult) condition versus low-control (i.e. easy) condition, on Preparing to Overcome Prepotency Task, measured by fMRI after 4-week treatment.|4 weeks|||beta coefficient of BOLD signal change||Standard Deviation|Mean
733937|NCT00423943|Primary|Percent Change in Accuracy on High-control (i.e., Difficult) Condition of Preparing to Overcome Prepotency Task|Accuracy change on high-control (i.e., difficult) condition of Preparing to Overcome Prepotency (POP) Task. For high-control condition (red-cue), subjects responded in the incongruent direction (eg, for a right-pointing arrow, press the left button, and vice versa). Increased values indicate improved performance.|Baseline, 4 weeks|||percent change in accuracy||Standard Deviation|Mean
733938|NCT00424008|Secondary|The Proportion of Symptom-free Days and Nights (Combined) Over the 12-week Treatment Period.|For each day of the evaluation period, symptoms were collected in the morning for the night's evaluation, and in the evening for the day's evaluation. Symptoms included coughing, wheezing, and difficulty breathing, each integer-scaled from 0=none to 3=severe. A symptom-free Day/Night is defined as a combined score of 0 across the morning and evening evaluations. The proportion of 0 scores across the Baseline period, and across the 12-week treatment period, is calculated to determine the overall proportion of symptom-free Days/Nights for each of these periods.|Baseline to Week 12|"Efficacy analyses were based on randomized subjects with Baseline and any post-baseline data (intent-to-treat principle).
The standard deviation is pooled. Least Squares Mean scores are obtained from an analysis of covariance model correcting for treatment, site effects, and the Baseline proportion of symptom-free days/nights as a covariate."||Proportion of symptom-free days/nights||Standard Deviation|Least Squares Mean
733939|NCT00424008|Secondary|Change From Baseline in Asthma Control Questionnaire (ACQ) Total Score at Week 12 Endpoint|The Asthma Control Questionnaire (ACQ) by Juniper et al. is a mean of 7 equally weighted composite scores; each scaled from 0=best case scenario to 6=worst case scenario on an integer scale. Composites include the following: How Often Woken by Asthma, How Bad Were Asthma Symptoms When You Woke, Activity Limitations, Shortness of Breath, Wheezing, Average Daily Short-Acting Beta 2-Agonist (SABA) Puffs, and physician-evaluated lung function. With the exception of physician-evaluated lung function collected at the visit, evaluations were over the last week recall period.|Baseline to Week 12|"Efficacy analyses were based on randomized subjects with Baseline and any postbaseline data (intent-to-treat principle).
The standard deviation is pooled. Least Squares Mean scores are obtained from an analysis of covariance model correcting for treatment, site effects, and the Baseline ACQ score as a covariate."||Scores on a scale||Standard Deviation|Least Squares Mean
733940|NCT00424008|Secondary|Onset-of-action Based on Change From Baseline FEV1 at the 5 Min Pulmonary Function Test (PFT) Assessment on Day 1|PFTs, including FEV1, were done on Day 1. Evaluations included 30 min before and immediately before the first dose, the mean of which was Baseline, and at intervals from 5 min to 12 hrs postdose. Onset of action was defined as statistically significant improvement of MF/F over F/SC in Change from Baseline FEV1 at the 5-min postdose evaluation on Day 1. The same series of PFTs were done at Week 12. Change from Baseline to Week 12 evaluations were calculated using the same Day 1 predose scores for Baseline. The Week-12 evaluation consisted of AUC FEV1 scores across the 12-hour postdose interval.|Baseline to 5 minutes post-dose on Day 1|"Participants with data at Day One 5 minutes post-dose.
The standard deviation is pooled. Least Squares Mean scores are obtained from an analysis of covariance model correcting for treatment, site effects, and the Baseline FEV1 (liters) as a covariate."||Liters||Standard Deviation|Least Squares Mean
733941|NCT00424008|Primary|The Area Under the Curve From 0 to 12 Hours [AUC](0-12 hr) of the Change From Baseline to the Week 12 Endpoint in Forced Expiratory Volume in One Second (FEV1)||Baseline to Week 12|Efficacy analyses were based on randomized subjects with Baseline and any post-baseline data (intent-to-treat principle). The standard deviation is pooled. Least Squares Mean scores are obtained from an analysis of covariance model correcting for treatment, site effects, and the Baseline FEV1 (liters) as a covariate.||Liter x hour||Standard Deviation|Least Squares Mean
733942|NCT00424021|Primary|Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure|The number of participants in the AMB-220-E analysis set who experienced AEs (including serious AEs) of mild severity (ie, did not interfere with routine activities and the subject may have experienced slight discomfort) that began after entering AMB-220-E (treatment-emergent AEs) and that occurred in more than 1 participant are summarized by dose group. The AMB-220-E analysis set consisted of all participants who received at least 1 dose of study drug during the AMB-220-E study.|Week 24 (AMB-220-E baseline) to Week 329.3|The AMB-220-E population consisted of all subjects who received at least 1 dose of study drug during the AMB-220-E study.||Participants|||Number
733943|NCT00424021|Primary|Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure|The number of participants in the AMB-220-E analysis set who experienced AEs (including serious AEs) of moderate severity (ie, interfered with routine activities and subject may have experienced significant discomfort) that began after entering AMB-220-E (treatment-emergent AEs) and that occurred in more than 1 participant are summarized by dose group. The AMB-220-E analysis set consisted of all participants who received at least 1 dose of study drug during the AMB-220-E study.|Week 24 (AMB-220-E baseline) to Week 329.3|The AMB-220-E population consisted of all subjects who received at least 1 dose of study drug during the AMB-220-E study.||Participants|||Number
733944|NCT00424021|Secondary|Long-term Survival|Long-term survival was defined as the time from initiation of active treatment to death. Results are presented as the Kaplan-Meier estimate (% probability) of survival after a given time.|Week 24 (AMB-220-E baseline) to Week 329.3|The AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study) was evaluated during the AMB-220-E study period.||Probability (%)|||Number
733945|NCT00424021|Secondary|Failure-free Treatment Status|Failure-free treatment status was defined as the time from initiation of active treatment to the first occurrence of death, lung transplantation, the addition of approved prostanoid therapy, or study withdrawal due to the addition of other clinically approved PAH therapeutic agents. Results are presented as the Kaplan-Meier estimate (% probability) of not having treatment failure after a given time.|Week 0 (NCT00046319 baseline) to Week 360|The NCT00046319 analysis set (all subjects who received at least 1 dose of study drug during the NCT00046319 study) was evaluated during the NCT00046319 and AMB-220-E study periods.||Probability (%)|||Number
733985|NCT00424177|Secondary|Number of Participants Who Responded (Platelet Count Greater Than or Equal to 50 Gi/L and at Least 2x Baseline) for at Least 80 Percent of Their On-therapy Assessments During Weeks 2-6.|CBC, platelet counts|Up to 42 days of dosing|Cycle 1 responders||participants|||Number
733946|NCT00424021|Secondary|Time to Clinical Worsening of PAH|Clinical worsening of PAH was defined as death, lung transplantation, hospitalization for PAH, atrial septostomy, the addition of approved prostanoid therapy, or study withdrawal due to the addition of other clinically approved PAH therapeutic agents. Sildenafil, a type 5 phosphodiesterase (PDE-5) inhibitor, had not received regulatory approval for the treatment of PAH until late in the conduct of AMB 220 and AMB 220-E, and did not count toward clinical worsening. Results are presented as the Kaplan-Meier estimate (% probability) of not having clinical worsening after a given time.|Week 0 (NCT00046319 baseline) to Week 360|The NCT00046319 analysis set (all subjects who received at least 1 dose of study drug during the AMB-220 study) was evaluated during the NCT00046319 and AMB-220-E study periods.||Probability (%)|||Number
733947|NCT00424021|Secondary|Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the SGA (LOCF) (Week 204)|The SGA was determined using a visual-analog scale. Subjects were asked the question, “How are you feeling today?” and were asked to draw a vertical mark on a 100-mm horizontal line in which zero represented “very poor” and 100 represented “excellent.”|180 weeks (Week 24 to Week 204)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.||Units on a Scale||Standard Deviation|Mean
733948|NCT00424021|Secondary|Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the SGA (LOCF) (Week 156)|The SGA was determined using a visual-analog scale. Subjects were asked the question, “How are you feeling today?” and were asked to draw a vertical mark on a 100-mm horizontal line in which zero represented “very poor” and 100 represented “excellent.”|132 weeks (Week 24 to Week 156)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.||Units on a Scale||Standard Deviation|Mean
733949|NCT00424021|Secondary|Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the SGA (LOCF) (Week 108)|The SGA was determined using a visual-analog scale. Subjects were asked the question, “How are you feeling today?” and were asked to draw a vertical mark on a 100-mm horizontal line in which zero represented “very poor” and 100 represented “excellent.”|84 weeks (Week 24 to Week 108)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.||Units on a Scale||Standard Deviation|Mean
733950|NCT00424021|Secondary|Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the SGA (LOCF) (Week 48)|The SGA was determined using a visual-analog scale. Subjects were asked the question, “How are you feeling today?” and were asked to draw a vertical mark on a 100-mm horizontal line in which zero represented “very poor” and 100 represented “excellent.”|24 weeks (Week 24 to Week 48)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.||Units on a Scale||Standard Deviation|Mean
733951|NCT00424021|Secondary|Baseline Measurement in Exercise Capacity as Measured by the Subject Global Assessment (SGA) (Baseline [Week 24])|The SGA was determined using a visual-analog scale. Subjects were asked the question, “How are you feeling today?” and were asked to draw a vertical mark on a 100-mm horizontal line in which zero represented “very poor” and 100 represented “excellent.”|Week 24 (AMB-220-E baseline)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study).||Units on a Scale||Standard Deviation|Mean
733952|NCT00424021|Secondary|Exercise Capacity as Measured by the WHO Functional Classification (LOCF) After 180 Weeks of Treatment in AMB-220-E|Classes: I) PH; ordinary physical activity not limited or causes increased dyspnea, fatigue, chest pain, or presyncope. II) PH; ordinary physical activity mildly limited and causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. III) PH; physical activity markedly limited and less than ordinary physical activity causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. IV) PH; physical activity causes symptoms; signs of right heart failure; dyspnea/fatigue possibly at rest.|180 weeks (Week 24 of NCT00046319 to Week 204)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.||Participants|||Number
733953|NCT00424021|Secondary|Exercise Capacity as Measured by the WHO Functional Classification (LOCF) After 132 Weeks of Treatment in AMB-220-E|Classes: I) PH; ordinary physical activity not limited or causes increased dyspnea, fatigue, chest pain, or presyncope. II) PH; ordinary physical activity mildly limited and causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. III) PH; physical activity markedly limited and less than ordinary physical activity causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. IV) PH; physical activity causes symptoms; signs of right heart failure; dyspnea/fatigue possibly at rest.|132 weeks (Week 24 of NCT00046319 to Week 156)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.||Participants|||Number
733954|NCT00424021|Secondary|Exercise Capacity as Measured by the WHO Functional Classification (LOCF) After 84 Weeks of Treatment in AMB-220-E|Classes: I) PH; ordinary physical activity not limited or causes increased dyspnea, fatigue, chest pain, or presyncope. II) PH; ordinary physical activity mildly limited and causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. III) PH; physical activity markedly limited and less than ordinary physical activity causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. IV) PH; physical activity causes symptoms; signs of right heart failure; dyspnea/fatigue possibly at rest.|84 weeks (Week 24 of NCT00046319 to Week 108)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.||Participants|||Number
734288|NCT00425308|Secondary|Change in Renal Function Assessed by Creatinine Clearance at Month 3, Month 6 and Month 12|Change in creatinine clearance, Nankivell formula (mL/min/1.73m²) from baseline to M12|From Baseline to Month 3, 6, and 12|Intent to Treat Population||mL/min/1.73m²||Standard Deviation|Mean
733955|NCT00424021|Secondary|Exercise Capacity as Measured by the WHO Functional Classification (LOCF) After 24 Weeks of Treatment in AMB-220-E|Classes: I) PH; ordinary physical activity not limited or causes increased dyspnea, fatigue, chest pain, or presyncope. II) PH; ordinary physical activity mildly limited and causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. III) PH; physical activity markedly limited and less than ordinary physical activity causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. IV) PH; physical activity causes symptoms; signs of right heart failure; dyspnea/fatigue possibly at rest.|24 weeks (Week 24 [baseline of AMB-220-E] to Week 48)|||Participants|||Number
733956|NCT00424021|Secondary|Baseline Measurement in Exercise Capacity as Measured by the World Health Organization (WHO) Functional Classification (Baseline [Week 24])|Classes: I) pulmonary hypertension (PH); ordinary physical activity not limited or causes increased dyspnea, fatigue, chest pain, or presyncope. II) PH; ordinary physical activity mildly limited and causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. III) PH; physical activity markedly limited and less than ordinary physical activity causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. IV) PH; physical activity causes symptoms; signs of right heart failure; dyspnea/fatigue possibly at rest.|Week 24 (AMB-220-E baseline)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.||Participants|||Number
733957|NCT00424021|Secondary|Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the BDI (LOCF) (Week 204)|Change from baseline evaluated after 24 (baseline), 48, 108, 156, and 204 weeks of ambrisentan therapy in BDI (measured as units on a scale) immediately following exercise. Borg Dyspnea Index, a measure of perceived shortness of breath: 0 units on a scale (none) to 10 units on a scale (maximum breathlessness).|180 weeks (Week 24 to Week 204)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.||Units on a Scale||Standard Deviation|Mean
733958|NCT00424021|Secondary|Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the BDI (LOCF) (Week 156)|Change from baseline evaluated after 24 (baseline), 48, 108, 156, and 204 weeks of ambrisentan therapy in BDI (measured as units on a scale) immediately following exercise. Borg Dyspnea Index, a measure of perceived shortness of breath: 0 units on a scale (none) to 10 units on a scale (maximum breathlessness).|132 weeks (Week 24 to Week 156)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.||Units on a Scale||Standard Deviation|Mean
733959|NCT00424021|Secondary|Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the BDI (LOCF) (Week 108)|Change from baseline evaluated after 24 (baseline), 48, 108, 156, and 204 weeks of ambrisentan therapy in BDI (measured as units on a scale) immediately following exercise. Borg Dyspnea Index, a measure of perceived shortness of breath: 0 units on a scale (none) to 10 units on a scale (maximum breathlessness).|84 weeks (Week 24 to Week 108)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.||Units on a Scale||Standard Deviation|Mean
733960|NCT00424021|Secondary|Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the BDI (LOCF) (Week 48)|Change from baseline evaluated after 24 (baseline), 48, 108, 156, and 204 weeks of ambrisentan therapy in BDI (measured as units on a scale) immediately following exercise. Borg Dyspnea Index, a measure of perceived shortness of breath: 0 units on a scale (none) to 10 units on a scale (maximum breathlessness).|24 weeks (Week 24 to Week 48)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.||Units on a Scale||Standard Deviation|Mean
733961|NCT00424021|Secondary|Baseline Measurement in Exercise Capacity as Measured by the Borg Dyspnea Index (BDI) (Baseline [Week 24])|Change from baseline evaluated after 24 (baseline), 48, 108, 156, and 204 weeks of ambrisentan therapy in BDI (measured as units on a scale) immediately following exercise. Borg Dyspnea Index, a measure of perceived shortness of breath: 0 units on a scale (none) to 10 units on a scale (maximum breathlessness).|Week 24 (AMB-220-E baseline)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.||Units on a Scale||Standard Deviation|Mean
733962|NCT00424021|Secondary|Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Distance (LOCF) (Week 204)|The 6MWT was conducted according to the American Thoracic Society guidelines (ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med 2002; 166(1):111-117.) Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study).|180 weeks (Week 24 to Week 204)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.||Meters||Standard Deviation|Mean
733963|NCT00424021|Secondary|Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Distance (LOCF) (Week 156)|The 6MWT was conducted according to the American Thoracic Society guidelines (ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med 2002; 166(1):111-117.) Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study).|132 weeks (Week 24 to Week 156)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.||Meters||Standard Deviation|Mean
733986|NCT00424177|Primary|Number of Participants Who Responded (Platelet Count >=50 Gi/L and >=2x Baseline) to Eltrombopag Treatment in Cycle 2 or Cycle 3 Given Participants Responded in Cycle 1|Complete blood count, platelet count by blood draw|Day 42 of each cycle|Primary Analysis Population: All participants who entered the study, received at least 1 dose of eltrombopag, and responded in Cycle 1||participants|||Number
733964|NCT00424021|Secondary|Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Distance (LOCF) (Week 108)|The 6MWT was conducted according to the American Thoracic Society guidelines (ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med 2002; 166(1):111-117.) Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study).|84 weeks (Week 24 to Week 108)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.||Meters||Standard Deviation|Mean
733965|NCT00424021|Secondary|Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Distance (Last Observation Carried Forward [LOCF]) (Week 48)|The 6MWT was conducted according to the American Thoracic Society guidelines (ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med 2002; 166(1):111-117.) Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study).|24 weeks (Week 24 to Week 48)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.||Meters||Standard Deviation|Mean
733966|NCT00424021|Secondary|Baseline Measurement in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Distance (Baseline [Week 24])|The 6MWT was conducted according to the American Thoracic Society guidelines (ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med 2002; 166(1):111-117.) Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study).|Week 24 (AMB-220-E baseline)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.||Meters||Standard Deviation|Mean
733967|NCT00424021|Primary|Number of Participants With Pulmonary Arterial Hypertension (PAH) Who Completed the Phase II NCT00046319 Study and Who Experienced Severe Adverse Events (AEs) During Long-term Ambrisentan Exposure|The number of participants in the AMB-220-E analysis set who experienced AEs (including serious AEs) of severe severity (ie, made it impossible to perform routine activities and the subject may have experienced intolerable discomfort or pain) that began after entering AMB-220-E (treatment-emergent AEs) and that occurred in more than 1 participant are summarized by dose group. The AMB-220-E analysis set consisted of all participants who received at least 1 dose of study drug during the AMB-220-E study.|Week 24 (AMB-220-E baseline) to Week 334|The AMB-220-E population consisted of all subjects who received at least 1 dose of study drug during the AMB-220-E study.||Participants|||Number
733987|NCT00424190|Secondary|Assess Safety|Comparisons of the number of participants with Adverse Events|First dose of study drug through TOC visit||||||
733980|NCT00424177|Secondary|Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score|ITP Bleeding Score: Grade 0 = no bleeding, Grade 1 = mild bleeding, Grade 2 = severe bleeding|Baseline, on-treatment visits (Weeks 1-6), off-treatment visits (Weeks 1-4)|Participants who responded in Cycle 1||participants|||Number
733981|NCT00424177|Secondary|Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale|World health Organization (WHO) Bleeding Scale Grade 0 = no bleeding, Grade 1 = petechiae, Grade 2 = mild blood loss, Grade 3 = gross blood loss, Grade 4 = debilitating blood loss.|Baseline, on-treatment visits (Weeks 1-6), off-treatment visits (Weeks 1-4)|Participants who responded in Cycle 1||participants|||Number
733982|NCT00424177|Secondary|Change in Participants Anti-platelet Antibody Levels From Baseline Through Follow-up|Change in participants' anti-platelet antibody levels was measured as the number of samples positive for at least 1 glycoprotein from baseline to follow-up. Serum glycoprotein-specific antigens: GPIIb/IIIa, Ib/IX, and Ia/IIa|Up to 1 year|Safety Population: any participant who received at least 1 dose of study medication||participants|||Number
733983|NCT00424177|Secondary|Number of Participants Who Required Rescue Medication|New idiopathic thrombocytopenic purpura (ITP) medication, increase dose of a concomitant ITP medication from baseline, platelet transfusion, and/or splenectomy|Up to 3 cycles of treatment including follow-up visits following last dose of eltrombopag|ITT Population||participants|||Number
733984|NCT00424177|Secondary|Changes in Participants' Platelet Counts During 3 Cycles of Treatment|Changes from baseline, during on-therapy periods of a cycle, during off-therapy periods of a cycle, and within 4 weeks of permanent discontinuation of eltrombopag treatment.|Up to 1 year|Intent-to-Treat (ITT) Population: All participants who were dispensed study medication||Gi/L||Full Range|Median
733994|NCT00424190|Primary|Clinical Cure Rate at Test of Cure (TOC) (MITT Population)|"Cure: Total resolution of all signs and symptoms of the baseline infection, or improvement of the infection such that no further antimicrobial therapy was necessary.
Failure: Requirement of alternative antimicrobial therapy for primary infection of cSSSI due to inadequate response, recurrence, new infection at the same site; treatment-limiting adverse event (AE); requirement for surgery due to failure of study drug; diagnosis of osteomyelitis after Study Day 8; or death caused by cSSSI.
Indeterminate: Inability to determine an outcome"|8-15 days after the end of treatment|MITT (Modified Intent to Treat) - Any randomized subjects that received any amount of study drug||participants|||Number
733995|NCT00424255|Secondary|Number of Participants With the Indicated Worst-case On-therapy Left Ventricular Ejection Fraction (LVEF) Change From Baseline|LVEF is the measurement of how much blood is being pumped out of the left ventricle of the heart with each contraction. LVEF was assessed using echocardiogram (ECHO: a test of the action of the heart using ultrasound waves to produce a visual display, for the diagnosis or monitoring of heart disease ) and multigated acqusition scans (MUGA scan: a noninvasive diagnostic test used to evaluate the pumping function of the ventricles). Data from the ECHO and MUGA scans were combined, and the absolute change from Baseline (Abs) data are presented according to the following categories: No change or any increase, 0-<10% decrease, 10-19% decrease, >=20% decrease, >=10% decrease and >=the Lower Limit of Normal (LLN), >=10% decrease and below LLN, >=20% decrease and >=LLN, or >=20% decrease and below LLN. The relative percent change from Baseline (Rel) data are presented according to the following categories: >=20% decrease and >=LLN and >=20% decrease and below LLN.|From the end of the CRT until the last follow-up visit (average of 141 study weeks)|Safety Population. Only those participants available at the specified time points were analyzed.||Participants|||Number
733996|NCT00424255|Secondary|Number of Participants With the Indicated Biomarker Expression Status|Biomarkers (which influence clinical response) assessed from tumor tissues included P16, Human Papilloma virus (HPV), and Epidermal Growth Factor Receptor (EGFR)/Epidermal Growth Factor Receptor 1 (ErbB1). Biomarker expression is presented as positive, negative, or unknown. Participants in the ErbB1-positive category include those with results of positive or strongly positive.|Baseline (BL; within 8 weeks prior to randomization [Day 1]) (up to Study Week 1)|ITT Population||Participants|||Number
733997|NCT00424255|Secondary|Change From Baseline in Quality of Life Status as Assessed by the EuroQol-5D (EQ-5D) Scale|Change from Baseline in quality of life status was assessed using the EQ-5D scale, a 5-item health status measure and a visual analog rating scale. Change from Baseline was analyzed using parametric analysis of covariance (with the Baseline value as a covariate). The EQ-5D is a generic measure of self-reported health outcomes that is applicable to a wide range of health conditions and treatments. The EQ-5D covers health status in 5 domains (3 questions each): mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each item is scored as follows: 1, no problems; 2, some moderate problems; 3, extreme problems. The possible EQ-5D index utility values range from 0.594 to 1, and the thermometer score ranges from 0 to 100. Higher scores represent better quality of life. Data were adjusted for participant-reported quality of life scores at Baseline.|From randomization until the last follow-up/withdrawal visit (up to 62 study weeks)|Safety Population. Only those participants who had a Baseline and post-Baseline score at the specified time points were analyzed.||scores on a scale||Standard Error|Least Squares Mean
733998|NCT00424255|Secondary|Change From Baseline in Quality of Life Status as Assessed by the Functional Assessement of Cancer Therapy-Head and Neck (FACT-H&N) Questionnaire|Change from Baseline in quality of life status was assessed using the FACT-H&N questionnaire, which is designed to measure multidimensional quality of life in participants with head and neck cancer. Change from Baseline was analyzed using parametric analysis of covariance (with the Baseline value as a covariate). The FACT-H&N questionnaire contains 39 items (27 general questions and 12 head and neck cancer-specific items) covering 4 dimensions and 1 subscale: physical well-being, social/family well-being, emotional well-being, functional well-being, and a head and neck cancer subscale. Possible subscale scores range from 0 to 36. Higher scores represent better quality of life. Data were adjusted for participant-reported quality of life scores at Baseline.|From randomization until the last follow-up/withdrawal visit (up to 62 study weeks)|Safety Population. Only those participants who had a Baseline and post-Baseline score at the specified time points were analyzed.||scores on a scale||Standard Error|Least Squares Mean
733999|NCT00424255|Secondary|Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value|The Eastern Cooperative Oncology Group (ECOG) performance status scales and grades/criteria are used by doctors and researchers to assess how a participant's disease is progressing, to assess how the disease affects the daily living abilities of the participant, and to determine appropriate treatment and prognosis. Grade 0, fully active, able to carry on all pre-disease performance without restriction. Grade 1, restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. Grade 2, ambulatory and capable of all selfcare, but unable to carry out any work activities; up and about more than 50% of waking hours. Grade 3, capable of only limited selfcare; confined to bed or chair more than 50% of waking hours. Grade 4, completely disabled; cannot carry on any selfcare; totally confined to bed or chair. Grade 5, dead.|From Baseline (BL; within 8 weeks prior to randomization [Day 1]) until the end of the maintenance period/early withdrawal (up to Study Week 64)|Safety Population||Participants|||Number
734000|NCT00424255|Secondary|Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings at the Indicated Time Points|A 12-lead ECG was recorded at Baseline, at the end of the CRT, at Maintenance Week 56, at withdrawal from IP, and at anytime post-baseline. Data are presented as clinically significant (CS) or not clinically significant (NCS) abnormal findings. The study investigator determined if an abnormal ECG finding was CS or NCS.|Baseline (BL; within 8 weeks prior to randomization [Day 1]), End of CRT, Maintenance Week 56, Withdrawal from IP, and at any time Post-Baseline (up to Study Week 64)|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Safety Population.||Participants|||Number
734096|NCT00424476|Secondary|Percent of Subjects Whose Average Prednisone Dose Has Been Reduced by ≥ 25% From Baseline to ≤ 7.5 mg/Day During Weeks 40 Through 52||Baseline, Weeks 40 through 52|Analysis was performed on a MITT population, defined as all subjects who were randomized and received at least 1 dose of study agent. Includes only subjects with baseline prednisone dose > 7.5 mg/day||Percentage of participants|||Number
734001|NCT00424255|Secondary|Change From Baseline in Body Weight at the Indicated Time Points|Body weight was measured at Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, End of CRT, MW 8, MW 16, MW 24, MW 32, MW 40, MW 48, MW 56, and at the time of withdrawal from IP. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, End of chemoradiotherapy (CRT), Maintenance Week (MW) 8, MW 16, MW 24, MW 32, MW 40, MW 48, MW 56, Withdrawal from IP (up to Study Week 64)|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Safety Population.||Kilograms||Standard Deviation|Mean
734002|NCT00424255|Secondary|Change From Baseline in Body Temperature at the Indicated Time Points|Body temperature was measured at Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, End of CRT, MW 8, MW 16, MW 24, MW 32, MW 40, MW 48, MW 56, and at the time of withdrawal from IP. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, End of chemoradiotherapy (CRT), Maintenance Week (MW) 8, MW 16, MW 24, MW 32, MW 40, MW 48, MW 56, Withdrawal from IP (up to Study Week 64)|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Safety Population.||Degrees Centigrade||Standard Deviation|Mean
734003|NCT00424255|Secondary|Change From Baseline in Heart Rate at the Indicated Time Points|Heart rate (HR) was measured at Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, End of CRT, MW 8, MW 16, MW 24, MW 32, MW 40, MW 48, MW 56, and at the time of withdrawal from IP. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, End of chemoradiotherapy (CRT), Maintenance Week (MW) 8, MW 16, MW 24, MW 32, MW 40, MW 48, MW 56, Withdrawal from IP (up to Study Week 64)|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Safety Population.||Beats per minute||Standard Deviation|Mean
734004|NCT00424255|Secondary|Change From Baseline in Blood Pressure at the Indicated Time Points|Blood pressure measurement included systolic blood pressure (SBP) and diastolic blood pressure (DBP) at Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, End of CRT, MW 8, MW 16, MW 24, MW 32, MW 40, MW 48, MW 56, and at the time of withdrawal from IP. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, End of chemoradiotherapy (CRT), Maintenance Week (MW) 8, MW 16, MW 24, MW 32, MW 40, MW 48, MW 56, Withdrawal from investigational product (IP; up to Study Week 64)|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Safety Population.||Millimeters of mercury (mmHg)||Standard Deviation|Mean
734005|NCT00424255|Secondary|Number of Participants With On-therapy and Follow-up Late Radiation Morbidity Events|Late radiation morbidity event data are summarized as the number of participants with late radiation morbidity events per system organ class (SOC). Late radiation effects are defined as those that first occur 90 days or more after the initiation of radiation therapy.|From 180 days after completion of radiation until the last follow-up/withdrawal visit (average of 64 study weeks)|Safety Population||Participants|||Number
734006|NCT00424255|Secondary|Number of Participants With the Indicated Hematological Toxicities by Maximum Toxicity Grade (G3 and G4) at the Worst-case On-therapy Visit|Data are summarized using the NCI CTC version 3.0 toxicity grades. Data are reported as the number of participants who had a grade 3 (G3) or grade 4 (G4) toxicity for the indicated hematological parameters, where G3 indicates a severe toxicity and G4 indicates a life-threatening toxicity. The worst-case on-therapy visit includes any scheduled or unscheduled post-Baseline visit. Hematology parameter included: hemoglobin, total neutrophils (TN), platelet count (PC), and White Blood Cell (WBC) count.|From Baseline (within 8 weeks prior torandomization [Day 1]) until the end of the maintenance period/early withdrawal (up to Study Week 64)|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Safety Population.||Participants|||Number
734007|NCT00424255|Secondary|Number of Participants With the Indicated Chemistry Toxicities by Maximum Toxicity Grade (G3 and G4) at the Worst-case On-therapy Visit|Data are summarized using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3 (NCI CTC version 3.0) toxicity grades. Data are reported as the number of participants who had a grade 3 (G3) or grade 4 (G4) toxicity for the indicated chemistry parameters, where G3 indicates a severe toxicity and G4 indicates a life-threatening toxicity. Clinical chemistry parameters included: albumin, alkaline phosphatase (AP), alanine amino transferase (ALT), aspartate amino transeferase (AST), total bilirubin (TB), calcium, carbon dioxide content/bicarbonate (CO2/HCO3), creatinine, glucose, potassium, and sodium. The worst-case on-therapy visit includes any scheduled or unscheduled post-Baseline visit.|From Baseline (within 8 weeks prior to randomization [Day 1]) until the end of the maintenance period/early withdrawal (up to Study Week 64)|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Safety Population.||Participants|||Number
734008|NCT00424255|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in deciding whether reporting is appropriate in other situations. Refer to the General Adverse AE/SAE module for a complete list of non-serious AEs occurring at a frequency threshold of 5% and SAEs.|From the first dose of lapatinib/placebo until 5 days after the last dose (average of 141 study weeks)|Safety Population||Participants|||Number
734009|NCT00424255|Secondary|Extent of Exposure|Extent of exposure is defined as the duration of treatment administered during the study. The mean duration of treatment is calculated as the number of days between the start of treatment and the end of treatment inclusive (i.e., treatment stop date minus treatment start date + 1). Participants were counted in a treatment phase (monotherapy, chemoradiotherapy, and maintenance) if they had received any dose in that phase. Participants randomized to placebo who received >=1 dose of lapatinib in error were included in the lapatinib arm.|From randomization until end of 1year maintenance treatment (average of 63 study weeks)|Safety Population (SP): all participants (par.) who were randomized and took >=1 dose of study medication. Only par. available at the specified time points were analyzed (represented by n=X, X in the category titles). Different par. may have been analyzed for different parameters, so the overall number of par. analyzed reflects everyone in the SP.||Weeks||Standard Deviation|Mean
734010|NCT00424255|Secondary|Number of Participants With a Second Primary Tumor|Participants who developed a second primary tumor at the time of the first recurrence or within 28 days of the first recurrence were measured. The criteria for a second primary tumor are as follows: a distinct lesion separated from the primary tumor site by >2 centimeters of normal epithelium; or a new cancer with different histology; or any cancer, regardless of site, occurring >=3 years after initial treatment. Participants with baseline disease were included in the denominator when calculating the percentage.|From randomization until development of second primary tumor or within 28 days of first recurrence (average of 101 study weeks)|ITT Population||Participants|||Number
734011|NCT00424255|Secondary|Time to Distant Relapse (TTDR)|TTDR is defined as the time from randomization until the first occurrence that distant relapse is documented. Distant relapse is defined as clear evidence of distant metastases (lung, bone, brain, etc.). Metastasis is defined as the spread of a cancer from one organ or part to another non-adjacent organ or part. All other events prior to a distant relapse were treated as competing risks at the time they occured. All other participants were treated as censored at the time of their last disease assessment. Participants with malignant disease at Baseline according to the independent review were censored at the time of randomization for the analysis of independently reviewed data.|From randomization until the first documented occurrence that distant relapse is documented (average of 101 study weeks)|ITT Population||Months||95% Confidence Interval|Median
734012|NCT00424255|Secondary|Time to Locoregional Recurrence (TTLR)|TTLR is defined as the time from randomization until the first occurrence that local and/or regional recurrence is documented or the date of censor. Local relapse is defined as recurrent cancer in the primary tumor bed not clearly attributable to a second primary neoplasm. Regional relapse is defined as recurrent cancer in the neck not clearly attributable to a second primary neoplasm. All other events prior to locoregional recurrence were treated as competing risks at the time they occured. All other participants were treated as censored at the time of their last disease assessment. Participants with malignant disease at Baseline according to the independent review were censored at the time of randomization for the analysis of independently reviewed data.|From randomization until thefirst occurrence that local and/or regional recurrence is documented or the date of censor (average of 101 study weeks)|ITT Population||Months||95% Confidence Interval|Median
734013|NCT00424255|Secondary|Disease Specific Survival (DSS)|DSS is defined as the time from randomization until death due to head and neck cancer. Participants whose death was not related to the disease under study were treated as competing risks at the time death occured. Participants who were alive were censored at the time of their last visit.|From randomization until death due to head and neck cancer (average of 131 study weeks)|ITT Population||Months||95% Confidence Interval|Median
734014|NCT00424255|Secondary|Overall Survival (OS)|OS is defined as the time from randomization until death due to any cause. For participants who did not die, the time to death was censored at the time of last visit/contact.|From randomization until death due to any cause (average of 131 study weeks)|ITT Population||Months||95% Confidence Interval|Median
734015|NCT00424255|Primary|Disease Free Survival (DFS)|DFS is defined as the time from randomization until the earliest date of disease recurrence (evidence of local, regional, or distant disease progression, second primary tumor) or death due to any cause. Disease recurrence was based on the assessments from the blinded, independent reviewer (radiological and clinical). Participants who initiated alternative anti-cancer therapy prior to disease recurrence or death were treated as censored at the last assessment prior to the time of this initiation. For participants whose disease did not recur or who did not die, DFS was censored at the time of the last independently assessed radiological scan (where initiation of alternative anti-cancer therapy had not commenced). Participants who missed two or more consecutive disease assessments were censored at the last assessment prior to the missed assessments. Participants considered to have malignant disease at Baseline were censored at the time of randomization.|From randomization until the earliest date of disease recurrence or death due to any cause (average of 101 study weeks)|Intent-to-Treat (ITT) Population: all participants who were randomized to study treatment, irrespective of whether they actually received study medication||Months||95% Confidence Interval|Median
734016|NCT00424268|Secondary|Shortness of Breath Questionnaire (SOBQ) Total Score|"Mean change from baseline during the treatment period in SOBQ. This is a 24-item measure that assesses self-reported shortness of breath while performing a variety of activities of daily living. The questions were administered at visits V0, V2, V3, V4, V5, V6 and Vend to assess the perceived shortness of breath of the patient. For each activity listed in the questionnaire the patient should rate his/her breathlessness on a scale between zero and five, where zero is not at all breathless and five is maximally breathless or too breathless to do the activity."|Change from baseline over 24 weeks of treatment|ITT analysis. Number of participants analyzed = number of participants with data available.||scores on a scale||Standard Error|Least Squares Mean
734017|NCT00424268|Secondary|Transition Dyspnea Index (TDI) Focal Score|The TDI is a recognized questionnaire to measure dyspnea in an out patient COPD population. At baseline, 3 components of dyspnea, each graded with 4 questions, were asked: - Functional Impairment - Magnitude of Task - Magnitude of Effort At each of the post-randomization visits questions from the TDI were asked related to 3 components: Change in - Functional Impairment - Magnitude of Task - Magnitude of Effort Each question in the TDI is graded from –3 (major deterioration) to +3 (major improvement). This results in a TDI Focal Score ranging from –9 to +9.|Change from baseline over 24 weeks of treatment|ITT analysis. Number of participants analyzed = number of participants with data available.||scores on a scale||Standard Error|Least Squares Mean
734018|NCT00424268|Secondary|COPD Exacerbation Rate (Moderate or Severe)|Mean rate of COPD exacerbations requiring oral or parenteral glucocorticosteroids (=moderate COPD exacerbations), or requiring hospitalization, or leading to death (=severe COPD exacerbations), per patient per year. A COPD exacerbation is an event in the natural course of the disease characterized by a change in the patient's baseline dyspnea, cough and/or sputum beyond day-to-day variability sufficient to warrant a change in management [American Thoracic Society (ATS) / European Respiratory Society (ERS) 2005].|24 weeks treatment period|ITT analysis||exacerbations per patient per year||95% Confidence Interval|Mean
734019|NCT00424268|Secondary|Post-bronchodilator FEV1|Mean change from baseline during the treatment period in post-bronchodilator FEV1 [L]|Change from baseline over 24 weeks of treatment|ITT analysis. Number of participants analyzed = number of participants with data available.||mL||Standard Error|Least Squares Mean
734020|NCT00424268|Primary|Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1)|Mean change from baseline during the treatment period in pre-bronchodilator FEV1 [L]|Change from baseline over 24 weeks of treatment|ITT (Intention to Treat) analysis. Number of participants analyzed = number of participants with data available.||mL||Standard Error|Least Squares Mean
734021|NCT00424294|Other Pre-specified|Number of Participants With Categorical Vital Signs Data|Number of participants with maximum increase from Baseline in sitting SBP and DBP of greater than or equal to 30 mmHg at Week 12 was reported.|Baseline, Week 12|Safety analysis set is same as FAS. FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug. Detailed categorical data was not estimated since summarized continuous data of the vital signs were considered sufficient for the analysis as per investigator’s discretion.||participants|||Number
734022|NCT00424294|Other Pre-specified|Number of Participants With Abnormal Electrocardiogram (ECG)|Criteria for potential clinical concern in ECG parameters: Maximum corrected QT interval (QTc) in range of 450 to less than 480 millisecond (msec), Maximum QTcB interval (Bazett’s Correction) (msec) in range of 450 to less than 480 msec, Maximum QTcF interval (Fridericia’s Correction) in range of 450 to less than 480 msec, maximum QTc interval increase from baseline in range of 30 to less than 60 msec and >=60 msec.|Baseline up to Week 12|Safety analysis set is same as FAS. FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.||participants|||Number
734023|NCT00424294|Other Pre-specified|Change From Baseline in Heart Rate Day 7, 14, 21, 28, 42, 56, 84 and 91||Baseline, Day 7, 14, 21, 28, 42, 56, 84, 91|Safety analysis set is same as FAS. FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug. Here, “n” signifies those participants who were evaluable at specified time point for each arm, respectively.||beats per minute||Standard Deviation|Mean
734024|NCT00424294|Other Pre-specified|Change From Baseline in Systolic and Diastolic Blood Pressure at Day 7, 14, 21, 28, 42, 56, 84 and 91|Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were evaluated in sitting position.|Baseline, Day 7, 14, 21, 28, 42, 56, 84, 91|Safety analysis set is same as FAS. FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug. Here, “n” signifies those participants who were evaluable at specified time point for each arm, respectively.||millimeter of mercury (mmHg)||Standard Deviation|Mean
734025|NCT00424294|Secondary|Number of Participants With Clinical Laboratory Abnormalities|Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); liver function (aspartate aminotransferase, alanine aminotransferase, total bilirubin, lactate dehydrogenase, alkaline phosphatase, albumin, total protein); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (sodium, potassium, chloride, calcium, phosphate, bicarbonate); clinical chemistry (glucose, creatine kinase); immunology (CRP); urinalysis (dipstick [urine specific gravity, decimal logarithm of reciprocal of hydrogen ion activity {pH} of urine, glucose, protein, blood, ketones, bilirubin], microscopy [urine RBC, WBC, urate crystals, calcium, oxalate, miscellaneous [urine mucus and leucocytes]).|Baseline up to Week 13|Safety analysis set is same as FAS. FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.||participants|||Number
734026|NCT00424294|Other Pre-specified|Number of Adverse Events by Severity|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs are classified according to the severity in 3 categories a) mild – AEs does not interfere with participant’s usual function b) moderate – AEs interferes to some extent with participant’s usual function c) severe – AEs interferes significantly with participant’s usual function.|Baseline up to 28 days after last dose|Safety analysis set is same as FAS. FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.||adverse events|||Number
734027|NCT00424294|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to 28 days after last dose|Safety analysis set is same as FAS. FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.||participants|||Number
734028|NCT00424294|Secondary|Time to Withdrawal Due to Lack of Efficacy||Baseline up to Week 12|Median time and corresponding confidence interval (CI) were not estimable because only less than half of the participants withdrew from study due to lack of efficacy and hence, were insufficient for the analysis.|||||
734029|NCT00424294|Secondary|Number of Participants Who Withdrew From Study Due to Lack of Efficacy||Baseline up to Week 12|FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.||participants|||Number
734110|NCT00424528|Secondary|Percentage of Participants With a >=1 Unit Improvement in Transition Dysnea Index (TDI) Focal Score|A Greater than or Equal to 1 unit of Improvement in the TDI Focal Score is considered to be clinically important.|2 weeks|Total number of subjects in each arm: 76, 80, 78||Percentage of participants|||Number
734030|NCT00424294|Secondary|Change From Baseline in Duration of Morning Stiffness at Week 1, 2, 4, 8 and 12|Duration of morning stiffness was defined as the time elapsed between the time participant woke up and was able to resume normal activities without stiffness in hours (duration was recorded in hours to the nearest quarter. For those participants with unrelenting stiffness, duration was recorded as 24 hours).|Baseline, Week 1, 2, 4, 8, 12|FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.Here,“n” signifies those participants who were evaluable at specified time point for each arm,respectively. For descriptive data,observed cases were reported and for statistical data,LOCF imputation method was used.||hour||Standard Deviation|Mean
734031|NCT00424294|Secondary|Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 1, 2, 4, 8 and 12|DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP. It was calculated as DAS28-3 (CRP) = 1.15 + 1.10 * ([0.56 * square root of TJC] + [0.28 * square root of SJC] + [0.36 * natural logarithm of {CRP+1}]). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission.|Baseline, Week 1, 2, 4, 8, 12|FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.Here,“n” signifies those participants who were evaluable at specified time point for each arm,respectively. For descriptive data,observed cases were reported and for statistical data,LOCF imputation method was used.||units on a scale||Standard Deviation|Mean
734032|NCT00424294|Secondary|Change From Baseline in C-Reactive Protein (CRP) at Week 1, 2, 4, 8 and 12|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 1, 2, 4, 8, 12|FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.Here,“n” signifies those participants who were evaluable at specified time point for each arm,respectively. For descriptive data,observed cases were reported and for statistical data,LOCF imputation method was used.||milligram per deciliter (mg/dL)||Standard Deviation|Mean
734033|NCT00424294|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 1, 2, 4, 8 and 12|Health Assessment Questionnaire-Disability Index (HAQ-DI): participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3, where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Week 1, 2, 4, 8, 12|FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.Here,“n” signifies those participants who were evaluable at specified time point for each arm,respectively. For descriptive data,observed cases were reported and for statistical data,LOCF imputation method was used.||units on a scale||Standard Deviation|Mean
734034|NCT00424294|Secondary|Change From Baseline in Physician’s Global Assessment of Arthritis at Week 1, 2, 4, 8 and 12|Investigator assessed overall appearance of arthritis at the time of the visit. The response was scored on a 5-point scale: 1 = Very Good (Asymptomatic and no limitation of normal activities), 2 = Good (Mild symptoms and no limitation of normal activities), 3 = Fair (Moderate symptoms and limitation of some normal activities), 4 = Poor (Severe symptoms and inability to carry out most normal activities) and 5 = Very Poor (Very severe symptoms which are intolerable and inability to carry out all normal activities).|Baseline, Week 1, 2, 4, 8, 12|FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.Here,“n” signifies those participants who were evaluable at specified time point for each arm,respectively. For descriptive data,observed cases were reported and for statistical data,LOCF imputation method was used.||units on a scale||Standard Deviation|Mean
734035|NCT00424294|Secondary|Change From Baseline in Patient’s Global Assessment of Arthritis at Week 1, 2, 4, 8 and 12|Patient’s global assessment of arthritic condition assessed all the ways participants’ illness and health conditions affect them at the time of assessment. The response was scored on a 5-point scale: 1 = Very Good (Asymptomatic and no limitation of normal activities), 2 = Good (Mild symptoms and no limitation of normal activities), 3 = Fair (Moderate symptoms and limitation of some normal activities), 4 = Poor (Severe symptoms and inability to carry out most normal activities) and 5 = Very Poor (Very severe symptoms which are intolerable and inability to carry out all normal activities).|Baseline, Week 1, 2, 4, 8, 12|FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.Here,“n” signifies those participants who were evaluable at specified time point for each arm,respectively. For descriptive data,observed cases were reported and for statistical data,LOCF imputation method was used.||units on a scale||Standard Deviation|Mean
734036|NCT00424294|Secondary|Change From Baseline in Patient's Assessment of Arthritis Pain at Week 1, 2, 4, 8 and 12|Patient's assessment of arthritis pain was assessed using a 100 millimeter (mm) visual analogue scale (VAS) with range: 0 = no pain to 100 = worst possible pain.|Baseline, Week 1, 2, 4, 8, 12|FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.Here,“n” signifies those participants who were evaluable at specified time point for each arm,respectively. For descriptive data,observed cases were reported and for statistical data,LOCF imputation method was used.||mm||Standard Deviation|Mean
734037|NCT00424294|Secondary|Change From Baseline in Swollen Joint Count (SJC) at Week 1, 2, 4, 8 and 12|Participants were assessed for swollen joints using a 28-joint count comprised of left and right shoulders, elbows, wrists, proximal interphalangeal joints, metacarpophalangeal joints and knees. Artificial joints were not assessed.|Baseline, Week 1, 2, 4, 8, 12|FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.Here,“n” signifies those participants who were evaluable at specified time point for each arm,respectively. For descriptive data,observed cases were reported and for statistical data,LOCF imputation method was used.||swollen joints||Standard Deviation|Mean
734289|NCT00425308|Secondary|Number of Participants With Treatment Failures Assessed by Biopsy-proven Acute Rejection (BPAR), Graft Loss/Re-transplantation, Death or Lost to Follow-up at Month 12.||Month 12|Intent to Treat (ITT) Population||participants|||Number
734038|NCT00424294|Secondary|Change From Baseline in Tender/Painful Joint Count (TJC) at Week 1, 2, 4, 8 and 12|Participants were assessed for tender/painful joints using a 28-joint count comprised of left and right shoulders, elbows, wrists, proximal interphalangeal joints, metacarpophalangeal joints and knees. Artificial joints were not assessed.|Baseline, Week 1, 2, 4, 8, 12|FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.Here,“n” signifies those participants who were evaluable at specified time point for each arm,respectively. For descriptive data,observed cases were reported and for statistical data,LOCF imputation method was used.||tender/painful joints||Standard Deviation|Mean
734039|NCT00424294|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response|ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Week 1, 2, 4, 8, 12|FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug. Missing values were imputed using LOCF method.||percentage of participants|||Number
734040|NCT00424294|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response|ACR50 response: >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Week 1, 2, 4, 8, 12|FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug. Missing values were imputed using LOCF method.||percentage of participants|||Number
734041|NCT00424294|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 1, 2, 4 and 8|ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Week 1, 2, 4, 8|FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug. Missing values were imputed using LOCF method.||percentage of participants|||Number
734042|NCT00424294|Primary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12|ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Week 12|FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug. Missing values were imputed using last observation carried forward (LOCF) method.||percentage of participants|||Number
734043|NCT00424346|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate During the Extension Study|Erythrocyte sedimentation rate (ESR) indirectly measures how much inflammation is in the body. A higher ESR is indicative of increased inflammation. A negative change from Baseline score indicates improvement.|Baseline and Weeks 24, 36, 48, 60, 72 and 88.|The Extension Study ITT population. At each timepoint, only patients with a value at both Baseline and that timepoint are included (N).||mm/hr||Standard Deviation|Mean
734044|NCT00424346|Secondary|Change From Baseline in High-sensitive C-Reactive Protein (hsCRP) Levels During the Extension Study|HsCRP is a marker for inflammation and was measured from blood samples to identify the presence of inflammation, to determine its severity, and to monitor response to treatment.|Baseline and Weeks 24, 36, 48, 60, 72, 88, 100, 112 and 124.|The Extension Study ITT population. At each timepoint, only patients with a value at both Baseline and that timepoint are included (N).||mg/L||Standard Deviation|Mean
734045|NCT00424346|Secondary|Change From Baseline in Health Assessment Questionnaire (HAQ) Score During the Extension Study|The patient health assessment questionnaire (HAQ) was used to assess the physical ability and functional status of participants as well as quality of life. The disability dimension consists of 20 multiple choice items concerning difficulty in performing eight common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Participants choose from four response categories, ranging from 'without any difficulty' (Score=0) to 'unable to do' (Score=3). The overall score is the average of each of the 8 category scores and ranges from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A negative change from Baseline score indicates improvement in disability status.|Baseline and Weeks 24, 36, 48, 60, 72, 88, 100, 112 and 124.|The Extension Study ITT population. At each timepoint, only patients with a value at both Baseline and that timepoint are included (N).||scores on a scale||Standard Deviation|Mean
734046|NCT00424346|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity During the Extension Study|The physician's global assessment of disease activity was performed using a 100 mm visual analog scale (VAS) ranging from no arthritis activity (0) to maximal arthritis activity (100). To enhance objectivity, the physician was not aware of the specific patient's global assessment of disease activity when performing their own assessment on that patient. The distance in mm from the left edge of the scale was measured. A negative change from Baseline score indicates improvement in assessment of disease activity.|Baseline and Weeks 24, 36, 48, 60, 72, 88, 100, 112 and 124.|The Extension Study ITT population. At each timepoint, only patients with a value at both Baseline and that timepoint are included (N).||scores on a scale||Standard Deviation|Mean
734111|NCT00424528|Secondary|Number of Participants With a >= 1 Unit of Improvement in the TDI Focal Score|A Greater than or Equal to 1 unit of Improvement in the TDI Focal Score is considered to be clinically important.|2 weeks|Total number of subjects in each arm: 76, 80, 78||Participants|||Number
734290|NCT00425308|Secondary|Number of Participants With Biopsy-proven Acute Rejection (BPAR) at Month 6 and Month 12.||Month 6 and 12|Intent to Treat Population||participants|||Number
734047|NCT00424346|Secondary|Change From Baseline in Patient's Global Assessment of Disease Activity During the Extension Study|"The patient's global assessment of disease activity was performed using a 100 mm visual analog scale (VAS) ranging from no arthritis activity (0) to maximal arthritis activity (100), after the question Considering all the ways your arthritis affects you, draw a line on the scale for how well you are doing. The distance in mm from the left edge of the scale was measured. A negative change from Baseline score indicates improvement in assessment of disease activity."|Baseline and Weeks 24, 36, 48, 60, 72, 88, 100, 112 and 124.|The Extension Study ITT population. At each timepoint, only patients with a value at both Baseline and that timepoint are included (N).||scores on a scale||Standard Deviation|Mean
734048|NCT00424346|Secondary|Change From Baseline in Patient's Pain Intensity During the Extension Study|The patient's assessment of pain was performed using a 100 mm visual analog scale (VAS) ranging from no pain (0) to unbearable pain (100). The distance in mm from the left edge of the scale was measured. A negative change from Baseline score indicates improvement in pain intensity.|Baseline and Weeks 24, 36, 48, 60, 72, 88, 100, 112 and 124.|The Extension Study ITT population. At each timepoint, only patients with a value at both Baseline and that timepoint are included (N).||scores on a scale||Standard Deviation|Mean
734049|NCT00424346|Secondary|Change From Baseline in Tender 28-joint Count During the Extension Study|The following 28 joints were assessed by the physician for tenderness: metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2).|Baseline and Weeks 24, 36, 48, 60, 72, 88, 100, 112 and 124.|The Extension Study ITT population. At each timepoint, only patients with a value at both Baseline and that timepoint are included (N).||tender joints||Standard Deviation|Mean
734050|NCT00424346|Secondary|Change From Baseline in Swollen 28-joint Count During the Extension Study|The following 28 joints were assessed by the physician for swelling: metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2).|Baseline and Weeks 24, 36, 48, 60, 72, 88, 100, 112 and 124.|The Extension Study ITT population. At each timepoint, only patients with a value at both Baseline and that timepoint are included (N).||swollen joints||Standard Deviation|Mean
734051|NCT00424346|Secondary|Number of Distinct Responders According to ACR20, ACR50 and ACR70 Criteria at the End of the Extension Study|"To assess differences between the level of clinical response attained and not just whether the patient did or did not achieve a particular level of response, patients were categorized as follows:
Did not attain an ACR20 response;
Attained a 20% but not a 50% response;
Attained a 50% but not a 70% response;
Attained a 70% or greater response.
A participant was considered as improved according to the ACR20, ACR50 or ACR70 criteria if they had at least a 20, 50 or 70% improvement from Baseline, respectively, in both the tender and the swollen 28-joint count, and in at least 3 of the following 5 measures:
Patient's pain assessment (100 mm visual analog scale [VAS]);
Patient's global assessment of disease activity (VAS 100 mm);
Physician's global assessment of disease activity (VAS 100 mm);
Patient self-assessed disability (Health Assessment Questionnaire [HAQ] score);
Acute phase reactant (high sensitivity C-reactive Protein [hsCRP])."|Baseline and End of Study (up to 124 weeks)|Extension Study ITT population.||participants|||Number
734052|NCT00424346|Primary|Change From Baseline in Disease Activity Score (DAS) 28 During the Extension Phase|"The Disease Activity Score (DAS) 28 is a combined index to measure the disease activity in patients with rheumatoid arthritis, and includes the following variables:
The number of swollen and tender joints assessed using the 28-joint count;
C-reactive protein (CRP) in mg/L;
Patient's global assessment of disease activity measured on a 100 mm visual analog scale.
The DAS28 score ranges from zero to ten. DAS28 above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity. Remission is achieved by a DAS28 lower than 2.6"|Baseline and Weeks 24, 72 and 112|The Extension Study intent-to-treat (ITT) population consisted of all patients who entered the extension study and who received at least one dose of study drug in the extension studies. At each timepoint, only patients with a value at both Baseline and that timepoint are included (N).||scores on a scale||Standard Deviation|Mean
734053|NCT00424346|Primary|Percentage of American College of Rheumatology [ACR] 70 Criteria Responders During the Extension Phase|"Participants were defined as ACR70 responders if they had at least a 70% improvement from Baseline in both the tender and the swollen 28-joint count, and in at least 3 of the following 5 measures:
Patient's pain assessment (assessed using a 100 mm Visual Analog Scale [VAS])
Patient's global assessment of disease activity (VAS 100 mm)
Physician's global assessment of disease activity (VAS 100 mm)
Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)
Acute phase reactant (high sensitivity C-reactive Protein [hsCRP]).
Participants were considered as non-responders if they failed the ACR70 criteria. Participants who prematurely discontinued due to insufficient therapeutic effect were also considered non-responders."|Baseline and Weeks 24, 36, 48, 60, 72, 88, 100, 112 and 124|The Extension Study intent-to-treat (ITT) population consisted of all patients who entered the extension study and who received at least one dose of study drug in the extension studies. The number of patients in the analysis at each time point (N) includes those with ACR70 evaluation data available.||percentage of participants|||Number
734054|NCT00424346|Primary|Percentage of American College of Rheumatology [ACR] 50 Criteria Responders During the Extension Phase|"Participants were defined as ACR50 responders if they had at least a 50% improvement from Baseline in both the tender and the swollen 28-joint count, and in at least 3 of the following 5 measures:
Patient's pain assessment (assessed using a 100 mm Visual Analog Scale [VAS])
Patient's global assessment of disease activity (VAS 100 mm)
Physician's global assessment of disease activity (VAS 100 mm)
Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)
Acute phase reactant (high sensitivity C-reactive Protein [hsCRP]).
Participants were considered as non-responders if they failed the ACR50 criteria. Participants who prematurely discontinued due to insufficient therapeutic effect were also considered non-responders."|Baseline and Weeks 24, 36, 48, 60, 72, 88, 100, 112 and 124|The Extension Study intent-to-treat (ITT) population consisted of all patients who entered the extension study and who received at least one dose of study drug in the extension studies. The number of patients in the analysis at each time point (N) includes those with ACR50 evaluation data available.||percentage of participants|||Number
734112|NCT00424528|Secondary|Transition Dyspnea Index (TDI) Focal Score|TDI Focal score (range -9 to 9) is defined as the sum of function impairment, magnitude of task, and magnitude of effort (each on a -3 to 3 scale). A score of -9 is maximum worsening and 9 is maximum improvement.|2 weeks|Total number of subjects in each arm: 76, 80, 78||Units on a scale||Standard Deviation|Mean
734055|NCT00424346|Primary|Percentage of American College of Rheumatology [ACR] 20 Criteria Responders During the Extension Phase|"Participants were defined as ACR20 responders if they had at least a 20% improvement from Baseline in both the tender and the swollen 28-joint count, and in at least 3 of the following 5 measures:
Patient's pain assessment (assessed using a 100 mm Visual Analog Scale [VAS])
Patient's global assessment of disease activity (VAS 100 mm)
Physician's global assessment of disease activity (VAS 100 mm)
Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)
Acute phase reactant (high sensitivity C-reactive Protein [hsCRP]).
Participants were considered as non-responders if they failed the ACR20 criteria. Participants who prematurely discontinued due to insufficient therapeutic effect were also considered non-responders."|Baseline and Weeks 24, 36, 48, 60, 72, 88, 100, 112 and 124|The Extension Study intent-to-treat (ITT) population consisted of all patients who entered the extension study and who received at least one dose of study drug in the extension studies. The number of patients in the analysis at each time point (N) includes those with ACR20 evaluation data available.||percentage of participants|||Number
734056|NCT00424346|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-F)|"The fatigue subscale of the FACIT is a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants respond to each item on a 5-point Likert-type scale (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; 4 = very much) based on their experience of fatigue during the past 2 weeks. The scale score is computed by summing the item scores, after reversing those items that are worded in the negative direction. FACIT Fatigue subscale scores range from 0 to 52, where higher scores represent less fatigue.
Least squares means (LSMs) were derived from an Analysis of Covariance (ANCOVA) model adjusting for treatment and center with baseline FACIT-F value as a covariate."|Baseline and Weeks 2, 4, 8 and 12|"ITT Population, only patients with a value at both Baseline and post-baseline are included in the analysis. The number of patients included at each time point is indicated by N. Last observation carried forward was utilized."||scores on a scale||Standard Error|Least Squares Mean
734057|NCT00424346|Secondary|Change From Baseline in Short Form 36 Health Survey (SF-36)|The SF-36 measures the impact of disease on overall quality of life and consists of eight subscales (physical function, pain, general and mental health, vitality, social function, physical and emotional health) which can be aggregated to derive a physical-component summary score and a mental-component summary score. Scores for each subscale range from 0 to 10, and the composite scores range from 0 to 100, with higher scores indicating better health. A positive change from Baseline score indicates improvement in quality of life.|Baseline and Weeks 2, 4, 8 and 12|"ITT Population, only patients with a value at both Baseline and post-baseline are included in the analysis. The number of patients included at each time point is indicated by N. Last observation carried forward was utilized."||scores on a scale||Standard Deviation|Mean
734058|NCT00424346|Secondary|Change From Baseline in Rheumatoid Factor Concentration|Rheumatoid factor (RF) is an autoantibody (antibody directed against an organism's own tissues) that is an indicator of inflammation and rheumatoid arthritis.|Baseline and Weeks 4, 8 and 12|"ITT Population, only patients with a value at both Baseline and post-baseline are included in the analysis. The number of patients included at each time point is indicated by N. Last observation carried forward was utilized."||kIU/L||Standard Deviation|Mean
734059|NCT00424346|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate|Erythrocyte sedimentation rate (ESR) indirectly measures how much inflammation is in the body. A higher ESR is indicative of increased inflammation. A negative change from Baseline score indicates improvement.|Baseline and Weeks 2, 4, 8 and 12|"ITT Population, only patients with a value at both Baseline and post-baseline are included in the analysis. The number of patients included at each time point is indicated by N. Last observation carried forward was utilized."||mm/hr||Standard Deviation|Mean
734060|NCT00424346|Secondary|Change From Baseline in Disease Activity Score (DAS) 28|"The Disease Activity Score (DAS) 28 is a combined index to measure the disease activity in patients with rheumatoid arthritis, and includes the following variables:
The number of swollen and tender joints assessed using the 28-joint count;
C-reactive protein (CRP) in mg/L;
Patient's global assessment of disease activity measured on a 100 mm visual analog scale.
The DAS28 score ranges from zero to ten. DAS28 above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity. Remission is achieved by a DAS28 lower than 2.6.
Least squares means (LSMs) were derived from an Analysis of Covariance (ANCOVA) model adjusting for treatment and center with baseline DAS28 value as a covariate."|Baseline and Weeks 2, 4, 8 and 12|"ITT Population, only patients with a value at both Baseline and post-baseline are included in the analysis. The number of patients included at each time point is indicated by N. Last observation carried forward was utilized."||scores on a scale||Standard Error|Least Squares Mean
734061|NCT00424346|Secondary|Change From Baseline in High-sensitive C-Reactive Protein (hsCRP) Levels|"HsCRP is a marker for inflammation and was measured from blood samples to identify the presence of inflammation, to determine its severity, and to monitor response to treatment.
Least squares means (LSMs) were derived from an Analysis of Covariance (ANCOVA) model adjusting for treatment and center with baseline value as a covariate."|Baseline and Weeks 2, 4, 8 and 12|"ITT Population, only patients with a value at both Baseline and post-baseline are included in the analysis. The number of patients included at each time point is indicated by N. Last observation carried forward was utilized."||mg/L||Standard Error|Least Squares Mean
734062|NCT00424346|Secondary|Change From Baseline in Health Assessment Questionnaire (HAQ) Score|"The patient health assessment questionnaire (HAQ) was used to assess the physical ability and functional status of participants as well as quality of life. The disability dimension consists of 20 multiple choice items concerning difficulty in performing eight common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Participants choose from four response categories, ranging from ‘without any difficulty' (Score=0) to 'unable to do' (Score=3). The overall score is the average of each of the 8 category scores and ranges from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A negative change from Baseline score indicates improvement in disability status.
Least squares means (LSM) were derived from an Analysis of Covariance (ANCOVA) model adjusting for treatment and center with baseline value as a covariate."|Baseline and Weeks 2, 4, 8 and 12|"ITT Population, only patients with a value at both Baseline and post-baseline are included in the analysis. The number of patients included at each time point is indicated by N. Last observation carried forward was utilized."||scores on a scale||Standard Error|Least Squares Mean
734063|NCT00424346|Secondary|Change From Baseline in Physician’s Global Assessment of Disease Activity|"The physician’s global assessment of disease activity was performed using a 100 mm visual analog scale (VAS) ranging from no arthritis activity (0) to maximal arthritis activity (100). To enhance objectivity, the physician was not aware of the specific patient’s global assessment of disease activity when performing their own assessment on that patient. The distance in mm from the left edge of the scale was measured. A negative change from Baseline score indicates improvement in assessment of disease activity.
Least squares means (LSM) were derived from an Analysis of Covariance (ANCOVA) model adjusting for treatment and center with baseline value as a covariate."|Baseline and Weeks 2, 4, 8 and 12|ITT Population, only patients with a value at both Baseline and post-baseline are included in the analysis. The number of patients included at each time point is indicated by||scores on a scale||Standard Error|Least Squares Mean
734064|NCT00424346|Secondary|Change From Baseline in Patient’s Global Assessment of Disease Activity|"The patient’s global assessment of disease activity was performed using a 100 mm visual analog scale (VAS) ranging from no arthritis activity (0) to maximal arthritis activity (100), after the question Considering all the ways your arthritis affects you, draw a line on the scale for how well you are doing”. The distance in mm from the left edge of the scale was measured. A negative change from Baseline score indicates improvement in assessment of disease activity.
Least squares means (LSM) were derived from an Analysis of Covariance (ANCOVA) model adjusting for treatment and center with baseline value as a covariate."|Baseline and Weeks 2, 4, 8 and 12|ITT Population, only patients with a value at both Baseline and post-baseline are included in the analysis. The number of patients included at each time point is indicated by||scores on a scale||Standard Error|Least Squares Mean
734065|NCT00424346|Secondary|Change From Baseline in Patient’s Pain Intensity|"The patient’s assessment of pain was performed using a 100 mm visual analog scale (VAS) ranging from no pain (0) to unbearable pain (100). The distance in mm from the left edge of the scale was measured. A negative change from Baseline score indicates improvement in pain intensity.
Least squares means (LSM) were derived from an Analysis of Covariance (ANCOVA) model adjusting for treatment and center with baseline value as a covariate."|Baseline and Weeks 2, 4, 8 and 12|ITT Population, only patients with a value at both Baseline and post-baseline are included in the analysis. The number of patients included at each time point is indicated by||scores on a scale||Standard Error|Least Squares Mean
734066|NCT00424346|Secondary|Change From Baseline in Tender 28-joint Count|"The following 28 joints were assessed by the physician for tenderness: metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2).
Least squares means (LSM) were derived from an Analysis of Covariance (ANCOVA) model adjusting for treatment and center with baseline value as a covariate."|Baseline and Weeks 2, 4, 8 and 12|"ITT Population, the number of patients included in the analysis at each time point is indicated by N. Last observation carried forward was utilized."||tender joints||Standard Error|Least Squares Mean
734067|NCT00424346|Secondary|Change From Baseline in Swollen 28-joint Count|"The following 28 joints were assessed by the physician for swelling: metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2).
Least squares means (LSM) were derived from an Analysis of Covariance (ANCOVA) model adjusting for treatment and center with baseline value as a covariate."|Baseline and Weeks 2, 4, 8 and 12|"ITT Population, the number of patients included in the analysis at each time point is indicated by N. Last observation carried forward was utilized."||swollen joints||Standard Error|Least Squares Mean
734068|NCT00424346|Secondary|Number of Distinct Responders According to ACR20, ACR50 and ACR70 Criteria at Week 12|"To assess differences between the level of clinical response attained and not just whether the patient did or did not achieve a particular level of response, participants were categorized as follows:
Did not attain an ACR20 response;
Attained a 20% but not a 50% response;
Attained a 50% but not a 70% response;
Attained a 70% or greater response.
A participant was considered as improved according to the ACR20, ACR50 or ACR70 criteria if they had at least a 20, 50 or 70% improvement from Baseline, respectively, in both the tender and the swollen 28-joint count, and in at least 3 of the following 5 measures:
Patient’s pain assessment (100 mm visual analog scale [VAS]);
Patient’s global assessment of disease activity (VAS 100 mm);
Physician’s global assessment of disease activity (VAS 100 mm);
Patient self-assessed disability (Health Assessment Questionnaire [HAQ] score);
Acute phase reactant (high sensitivity C-reactive Protein [hsCRP])."|Baseline and Week 12|The intent-to-treat (ITT) population. The number of patients in the analysis includes those with ACR evaluation. Last observation carried forward was applied for all the component variables.||participants|||Number
734069|NCT00424346|Secondary|Percentage of American College of Rheumatology [ACR] 70 Criteria Responders|"Participants were defined as ACR70 responders if they had at least a 70% improvement from Baseline in both the tender and the swollen 28-joint count, and in at least 3 of the following 5 measures:
Patient's pain assessment (assessed using a 100 mm Visual Analog Scale [VAS]);
Patient's global assessment of disease activity (VAS 100 mm);
Physician's global assessment of disease activity (VAS 100 mm);
Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score);
Acute phase reactant (high sensitivity C-reactive Protein [hsCRP]).
Participants were considered ACR70 non-responders if they failed the ACR70 criteria. Patients who prematurely discontinued the study due to insufficient therapeutic effect were also considered non responders."|Baseline and Weeks 2, 4, 8 and 12|"The intent-to-treat (ITT) population. The number of patients in the analysis includes those with ACR70 evaluation. Last observation carried forward was applied for all the component variables. N indicates the number of patients included at each time point."||percentage of participants|||Number
734070|NCT00424346|Secondary|Percentage of American College of Rheumatology [ACR] 20 Criteria Responders|"Participants were defined as ACR20 responders if they had at least a 20% improvement from Baseline in both the tender and the swollen 28-joint count, and in at least 3 of the following 5 measures:
Patient's pain assessment (assessed using a 100 mm Visual Analog Scale [VAS]);
Patient's global assessment of disease activity (VAS 100 mm);
Physician's global assessment of disease activity (VAS 100 mm);
Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score);
Acute phase reactant (high sensitivity C-reactive Protein [hsCRP]).
Participants were considered ACR20 non-responders if they failed the ACR20 criteria. Patients who prematurely discontinued the study due to insufficient therapeutic effect were also considered non responders."|Baseline and Weeks 2, 4, 8 and 12|"The intent-to-treat (ITT) population. The number of patients in the analysis includes those with ACR20 evaluation. Last observation carried forward was applied for all the component variables. N indicates the number of patients included at each time point."||percentage of participants|||Number
734071|NCT00424346|Secondary|Percentage of American College of Rheumatology [ACR] 50 Criteria Responders at Weeks 2, 4 and 8|"Participants were defined as ACR50 responders if they had at least a 50% improvement from Baseline in both the tender and the swollen 28-joint count, and in at least 3 of the following 5 measures:
Patient's pain assessment (assessed using a 100 mm Visual Analog Scale [VAS]);
Patient's global assessment of disease activity (VAS 100 mm);
Physician's global assessment of disease activity (VAS 100 mm);
Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score);
Acute phase reactant (high sensitivity C-reactive Protein [hsCRP]).
Participants were considered as non-responders if they failed the ACR50 criteria. Participants who prematurely discontinued due to insufficient therapeutic effect were also considered non-responders."|Baseline and Weeks 2, 4 and 8|"The intent-to-treat (ITT) population. The number of patients in the analysis includes those with ACR50 evaluation. Last observation carried forward was applied for all the component variables. N indicates the number of patients included at each time point."||percentage of participants|||Number
734072|NCT00424346|Primary|Percentage of American College of Rheumatology [ACR] 50 Criteria Responders at Week 12|"Participants were defined as ACR50 responders if they had at least a 50% improvement from Baseline in both the tender and the swollen 28-joint count, and in at least 3 of the following 5 measures:
Patient’s pain assessment (assessed using a 100 mm Visual Analog Scale [VAS]);
Patient’s global assessment of disease activity (VAS 100 mm);
Physician’s global assessment of disease activity (VAS 100 mm);
Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score);
Acute phase reactant (high sensitivity C-reactive Protein [hsCRP]).
Details on each of these components are provided in Outcome Measures 10-16. Participants were considered as non-responders if they failed the ACR50 criteria. Participants who prematurely discontinued due to insufficient therapeutic effect were also considered non-responders."|Baseline and Week 12|The intent-to-treat (ITT) population consisted of all patients as randomized that received at least one dose of study drug and had at least one post-baseline efficacy assessment. The number of patients in the analysis includes those with ACR50 evaluation. Last observation carried forward was applied for all the component variables.||percentage of participants|||Number
734073|NCT00424372|Primary|Summary of Adverse Events|Number of subjects with all causality adverse events, serious adverse events, severe adverse events, adverse events resulted in discontinuation, dose reduced or temporary discontinuation. Subjects are counted only once per treatment in each row.|52 weeks|Safety population: all subjects who took at least 1 dose of study medication.||subjects|||Number
734074|NCT00424372|Secondary|Short-Form McGill Pain Questionnaire the Efficacy of Change: Visual Analog Scale|Ranges: 0-100 mm. Larger scale indicate more severe pain. Baseline: The last evaluation on or before Day 1 of double-blind for subjects that took pregabalin in double-blind and last visit <= Day 1 of open-label for subjects that took placebo in double-blind. Endpoint: The last evaluation during dose adjustment/maintenance step of open-label.|52 weeks|Full Analysis Set, N = Number of subjects assessed||mm||Standard Deviation|Mean
734075|NCT00424372|Secondary|Short-Form McGill Pain Questionnaire the Efficacy of Change: Present Pain Intensity|Score ranges: 0-5. Higher scores indicate more severe pain. Baseline: The last evaluation on or before Day 1 of double-blind for subjects that took pregabalin in double-blind and last visit <= Day 1 of open-label for subjects that took placebo in double-blind. Endpoint: The last evaluation during dose adjustment/maintenance step of open-label.|52 weeks|Full Analysis Set, N = Number of subjects assessed||score on scale||Standard Deviation|Mean
734076|NCT00424372|Secondary|Short-Form McGill Pain Questionnaire the Efficacy of Change: Total Score|Score ranges: 0-45. Higher scores indicate more severe pain. Baseline: The last evaluation on or before Day 1 of double-blind for subjects that took pregabalin in double-blind and last visit <= Day 1 of open-label for subjects that took placebo in double-blind. Endpoint: The last evaluation during dose adjustment/maintenance step of open-label.|52 weeks|Full Analysis Set, N = Number of subjects assessed||score on scale||Standard Deviation|Mean
734077|NCT00424372|Secondary|Short-Form McGill Pain Questionnaire the Efficacy of Change: Affective Score|Score ranges: 0-12. Higher scores indicate more severe pain. Baseline: The last evaluation on or before Day 1 of double-blind for subjects that took pregabalin in double-blind and last visit <= Day 1 of open-label for subjects that took placebo in double-blind. Endpoint: The last evaluation during dose adjustment/maintenance step of open-label.|52 weeks|Full Analysis Set, N = Number of subjects assessed||score on scale||Standard Deviation|Mean
734078|NCT00424372|Secondary|Short-Form McGill Pain Questionnaire the Efficacy of Change: Sensory Score|Score ranges: 0-33. Higher scores indicate more severe pain. Baseline: The last evaluation on or before Day 1 of double-blind for subjects that took pregabalin in double-blind and last visit <= Day 1 of open-label for subjects that took placebo in double-blind. Endpoint: The last evaluation during dose adjustment/maintenance step of open-label.|52 weeks|Full Analysis Set, N = Number of subjects assessed||score on scale||Standard Deviation|Mean
734079|NCT00424385|Secondary|Time to Disease Progression (TTP)|Medium TTP is 2 months (range 1-5). 10 patients were evaluable for disease progression for these patients occurred between 1-5 months after starting the study. The TTP was calculated per protocol. For radiographic assessment Response Evaluation Criteria in Solid Tumors (RECIST) was used. Complete response = disappearance of all lesions. Partial response (PR)=30% or greater decrease in sum of longest diameter of measureable lesions SD. Lesions have no sufficient decrease for progressive disease and no sufficient increase to meet Progressive Disease (PD). PD more than 20% increase in sum of longest diameter of measurable lesions or 2 or more new bone mets. prostate-specific antigen (PSA) assessment for patients with measurable disease, PSA progression in the absence of measurable disease progression will not be considered progressive disease.|up to 5 cycles, an average of 20 weeks, from the day of first treatment until the date of the last dose of study drug|||months||Full Range|Median
734080|NCT00424385|Secondary|Overall Clinical Benefit|Overall Clinical Benefit was measured as the sum of complete response (CR), partial response (PR), and stable disease (SD).|up to 20 weeks|There were 17 patients enrolled. 10 were evaluable for assessment of overall clinical benefit. 7 were not evaluable due to having received <1 cycle of drug.||percentage of evaluable participants|||Number
734113|NCT00424528|Secondary|Levalbuterol Metered Dose Inhaler (MDI) Rescue Medication Use in Actuations Per Day|Overall: Average of the usage in number of actuations per day over the 2 week period. An actuation is one puff of levalbuterol. Mean number of actuations/day=number actuations used during time period, divided by number of days in time period.|2 weeks|||Actuations per day||95% Confidence Interval|Mean
734081|NCT00424385|Primary|Number of Patients Experiencing Dose Limiting Toxicities (DLT's)|Eligible patients were enrolled in one of 4 cohorts, where each cohort allowed 3 evaluable patients to be on study, patients withdrawn from treatment for reasons other than toxicity were not considered evaluable. If one of the three evaluable patients experienced a dose limiting toxicity (DLT) the cohort was expanded to 6 evaluable patients. Patients will receive both study drugs on escalated dosing schedule until the maximum of 400 mg PO BID is reached for both drugs or toxicity is established. If 2 out of six evaluable patients experience a dose limiting toxicity this would show that the Maximum Tolerated Dose (MTD) was the dose from the prior cohort.|up to 20 weeks|Cohort 0: 6 evaluable patients were enrolled. Patients who withdrew for reasons other than toxicity were not considered evaluable for MTD. 1 out of 6 patients had a DLT, therefore Cohort 1 was started. Cohort 1: 2 DLTs were demonstrated from 5 evaluable patients. By definition the Maximum tolerated dose was the dosing schedule used in cohort 0.||participants|||Number
734082|NCT00424398|Secondary|Total Nasal Symptom|Total Nasal Symptom score (Composite of Rhinorrhea, Nasal Pruritus, Ear or Palate Pruritus, and Nasal Congestion): 0 = None; 1.0 = Mild; 2.0 = Moderate; 3.0 = Moderate/Severe; 4.0 = Severe|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model|||Units on a scale||Standard Deviation|Mean
734083|NCT00424398|Secondary|Eyelid Swelling|Eyelid Swelling score: 0 = None; 1.0 = Mild-Detectable swelling of lower and/or upper lid; 2.0 = Moderate-Definite swelling of lower and/or upper lid; 3.0 = Severe-Swelling of lower and/or upper lid to the point that there is a decrease in the space between your upper and lower lids|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model|||Units on a scale||Standard Deviation|Mean
734084|NCT00424398|Secondary|Ocular Mucus Discharge|Percent of Eyes with Ocular Mucus Discharge. Scored as absent or present|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model|||Percent of Eyes with OMD Present|||Number
734085|NCT00424398|Secondary|Tearing|Percent of Eyes with Tearing. Scored as absent or present|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model|||Percent of Eyes with Tearing Present|||Number
734086|NCT00424398|Secondary|Nasal Congestion|Nasal Congestion score: 0 = None-Breathes freely; 1.0 = Mild-Breathes with difficulty; 2.0 = Moderate-One nostril partially blocked; 3.0 = Moderate/Severe-Both nostrils partially blocked or one nostril completely blocked and the other nostril partially blocked; 4.0 = Severe-Both nostrils completely blocked|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen challenge (CAC) Model|||Units on a scale||Standard Deviation|Mean
734087|NCT00424398|Secondary|Ear or Palate Pruritus (Itchy Ear or Palate)|Ear or Palate Pruritus score: 0 = None; 1.0 = Mild-An intermittent tickle sensation; 2.0 = Moderate-A mild continuous itch; 3.0 = Moderate/Severe-A severe itch with desire to rub; 4.0 = Severe-Incapacitating itch with an irresistible urge to rub|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model|||Units on a scale||Standard Deviation|Mean
734088|NCT00424398|Secondary|Nasal Pruritus (Itchy Nose)|Nasal Pruritus score: 0 = None; 1.0 = Mild-An intermittent tickle sensation; 2.0 = Moderate-A mild continuous itch; 3.0 = Moderate/Severe-A severe itch with desire to rub; 4.0 = Severe-Incapacitating itch with an irresistible urge to rub|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model|||Units on a scale||Standard Deviation|Mean
734089|NCT00424398|Secondary|Rhinorrhea (Runny Nose)|Rhinorrhea score: 0 = None; 1.0 = Mild-Sensation of nasal mucus flowing down nasal passage; no discharge present; 2.0 = Moderate-May be associated with post-nasal drip; nasal mucus flow more pronounced; will need to blow nose soon; 3.0 = Moderate/Severe-Nasal mucus discharge requiring occasional wiping with Kleenex; 4.0 = Severe-Uncontrolled nasal discharge; requiring frequent wiping and blowing nose|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model|||Units on a scale||Standard Deviation|Mean
734090|NCT00424398|Secondary|Chemosis|Chemosis score: 0 = None; 1.0 = Mild-Detectable only by slit lamp beam; definite separation of conjunctiva from sclera; 2.0 = Moderate-Visible in normal room light; more diffuse edema; 3.0 = Severe-Conjunctival billowing at the limbus; very diffuse and noticeable; 4.0 = Extremely Severe-Overall ballooning of conjunctiva|15 Minutes, 8 Hours & s6 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model|||Units on a scale||Standard Deviation|Mean
734091|NCT00424398|Secondary|Episcleral Redness|Episcleral Redness score: 0=None; 1.0=Mild-Slightly dilated blood vessels; color of vessels typically pink; 2.0=Moderate-More apparent dilation of blood vessels; vessel color more intense (redder); 3.0=Severe-Numerous, obvious dilated blood vessels; absence of chemosis color is deep red, presence of chemosis may be less red or pink; 4.0=Extremely Severe-Large, numerous dilated blood vessels characterized by severe deep red color regardless of chemosis grade|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model|||Units on a scale||Standard Deviation|Mean
734092|NCT00424398|Secondary|Ciliary Redness|Ciliary Redness score: 0=None; 1.0=Mild-Slightly dilated blood vessels; color of vessels typically pink; 2.0=Moderate-More apparent dilation of blood vessels; vessel color more intense (redder); 3.0=Severe-Numerous, obvious dilated blood vessels; absence of chemosis color is deep red, presence of chemosis may be less red or pink; 4.0=Extremely Severe-Large, numerous dilated blood vessels characterized by severe deep red color regardless of chemosis grade|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model|||Units on a scale||Standard Deviation|Mean
734093|NCT00424398|Primary|Conjunctival Redness|Conjunctival Redness score: 0=None; 1.0=Mild-Slightly dilated blood vessels; color of vessels typically pink; 2.0=Moderate-More apparent dilation of blood vessels; vessel color more intense (redder); 3.0=Severe-Numerous, obvious dilated blood vessels; absence of chemosis color is deep red, presence of chemosis may be less red or pink; 4.0=Extremely Severe-Large, numerous dilated blood vessels characterized by severe deep red color regardless of chemosis grade|15 minutes, 8 hours & 16 hours post-dose from Conjunctival Allergen Challenge (CAC) Model|||Units on a scale||Standard Deviation|Mean
734094|NCT00424398|Primary|Ocular Itching|Ocular Itching score: 0=None; 0.5=Intermittent tickle sensation possibly localized in the corner of the eye; 1.0=Intermittent tickle sensation involving more than the corner of the eye; 1.5=Intermittent all-over tickling sensation; 2.0=Mild continuous itch (can be localized) without desire to rub; 2.5=Moderate, diffuse continuous itch with desire to rub; 3.0=Severe itch with desire to rub; 3.5=Severe itch improved with minimal rubbing; 4.0=Incapacitating itch with irresistible urge to rub|15 minutes, 8 hours & 16 hours post-dose from Conjunctival Allergen Challenge (CAC) Model|||Units on a scale||Standard Deviation|Mean
734095|NCT00424476|Other Pre-specified|Adverse Events (AE) Overview|SEE ALSO ADVERSE EVENTS RESULTS SECTION|Up to 56 Weeks|||Percentage of participants|||Number
734097|NCT00424476|Secondary|Mean Change From Baseline in Medical Outcomes 36-Item Short Form Health Survey (SF-36) Physical Component Summary Score (PCS) at Wk 24.|The SF-36 is a generic health related quality of life (HRQOL) measurement. The survey includes 36 questions grouped to 8 domains and 2 summary measures (physical and mental health component, PCS and MCS, respectively) assessing HRQOL. Responses are scored according to the SF-36v2™ manual. A score is calculated for each SF-36 domain based on the patient's response to each question within it. This is then transformed to a scale ranging from 0 (worst) to 100 (best) points. The PCS is norm-based where the mean=50 and standard deviation (SD)=10. Higher scores represent better physical health.|Baseline, 24 weeks|Analysis was performed on a MITT population, defined as all subjects who were randomized and received at least 1 dose of study agent.||Scores on a scale||Standard Error|Mean
734098|NCT00424476|Secondary|Mean Change in Physician's Global Assessment (PGA) at Wk 24.|The PGA is a visual analog scale scored from 0 to 3. A score of 1 corresponds to mild lupus disease activity. A score of 2 correlates with moderate disease activity and a score of 3 with severe disease activity.|Baseline, 24 weeks|Analysis was performed on a MITT population, defined as all subjects who were randomized and received at least 1 dose of study agent.||Scores on a 3-point scale||Standard Error|Mean
734099|NCT00424476|Secondary|Percent of Subjects With a ≥ 4 Point Reduction From Baseline in SELENA SLEDAI Score at Wk 52.||Baseline, 52 weeks|Analysis was performed on a MITT population, defined as all subjects who were randomized and received at least 1 dose of study agent.||Percentage of participants|||Number
734100|NCT00424476|Primary|SLE Responder Index (SRI) Response Rate at Week 52|"Percentage of subjects with a ≥ 4 point reduction from baseline in SELENA SLEDAI score, and no worsening (increase of < 0.30 points from baseline) in PGA, and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with baseline.
SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare. PGA is a visual analog scale scored from 0 to 3 (1=mild, 2=moderate, 3=severe). BILAG uses a single score for each of the 8 organ domains; range is from severe to no disease (A to E)."|Baseline, 52 weeks|Analysis was performed on a modified intention-to-treat (MITT) population, defined as all subjects who were randomized and received at least 1 dose of study agent. Subjects who required rescue SLE medications were declared nonresponders, as were subjects who dropped out or were missing Week 52 data.||Percentage of participants|||Number
734101|NCT00424502|Secondary|C-Reactive Protein (CRP)|CRP was measured in milligrams per liter (mg/L).|Day 0 and Week 24|All participants who received at least 1 dose of study drug.||mg/L||Standard Deviation|Mean
734102|NCT00424502|Secondary|Erythrocyte Sedimentation Rate (ESR)|ESR was measured in mm/hr.|Day 0 and Week 24|All participants who received at least 1 dose of study drug.||mm/hr||Standard Deviation|Mean
734103|NCT00424502|Secondary|Vascular Endothelial Growth Factor (VEGF)|VEGF was measured as picograms per milliliter (pg/mL).|Day 0 and Week 24|All participants who received at least 1 dose of study drug.||pg/mL||Standard Deviation|Mean
734104|NCT00424502|Secondary|Anti-cyclic Citrullinated Peptide (Anti-CCP)|Anti-CCP measured as absorbance units per milliliter (AU/mL).|Day 0 and Week 24|All participants who received at least 1 dose of study drug; n=number of participants assessed for the specified parameter at a given visit.||AU/mL||Standard Deviation|Mean
734105|NCT00424502|Secondary|Health Assessment Questionnaire - Disability Index (HAQ-DI) Scores|The HAQ-DI score consists of questions referring to 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. For each of the categories, participants reported the amount of difficulty they had in performing 2 or 3 specific subcategory items. The standard disability score was calculated from the 8 categories by dividing the sum of the individual categories by the number of categories answered, yielding a score from 0 (without any difficulty) to 3 (unable to do).|Day 0 and Week 24|All enrolled participants. n (number) = number of participants assessed for the specified parameter at a given visit.||units on a scale||Standard Deviation|Mean
734106|NCT00424502|Primary|Disease Activity Score Based on 28-Joint Count (DAS28)|DAS28 consists of swollen joint count (SJC) and tender joint count (TJC) measurements, erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]), and Patient Global Assessment of Disease Activity (participant-rated assessment of arthritis) with transformed scores ranging from 0 to 10. Higher scores indicated greater affectation due to disease activity. DAS28 equal to or less than (≤)3.2 equals (=) low disease activity, greater than (>)3.2 to 5.1 = moderate to high disease activity.|Day 0 and Week 24|All enrolled participants who received at least one dose of study treatment.||units on a scale||Standard Deviation|Mean
734107|NCT00424515|Secondary|Overall Survival|Overall survival (OS) is defined as the time from study entry to death or date last known alive.|Patients were followed long-term every 3 months until first progression, death or lost to follow-up. Median survival follow-up was 10.6 months (range 3.7-27.1).|The analysis dataset is comprised of treated patients.||months||95% Confidence Interval|Median
734108|NCT00424515|Secondary|Time to Progression|Time to progression (TTP) based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.|Disease was evaluated radiologically at baseline, after 6-weeks, and at 2-month intervals on treatment and every 3 months long-term. Mean treatment duration was 4 months (range 1-11; amplified/mutated 3m/ 6m).|The analysis dataset is comprised of treated patients.||months||95% Confidence Interval|Median
734109|NCT00424515|Primary|Best Overall Response|Best overall response (BOR) on treatment was based on RECIST 1.0 criteria. For target lesions, complete response (CR) is complete disappearance of all target lesions and partial response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. CR or PR confirmation required within 4 weeks. Progressive disease (PD) is at least a 20% increase in the sum LD of target lesions from smallest sum LD as reference or the appearance of one or more new lesions. Stable disease (SD) is neither meeting PR or PD. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions. CR is disappearance of all non-target lesions.|Disease was evaluated radiologically at baseline, after 6-weeks, and at 2-month intervals on treatment. Mean treatment duration was 4 months (range 1-11; amplified/mutated 3m/ 6m).|The analysis dataset is comprised of treated patients.||participants|||Number
734114|NCT00424528|Secondary|Levalbuterol Metered Dose Inhaler (MDI) (Rescue Medication) Use in Days Per Week|Overall: Average of the levalbuterol usage in days per week over the 2 week period. Mean number of days/week=number of days levalbuterol used during time period, divided by number of days in the period, multiplied by 7. An actuation is one puff of levalbuterol.|2 weeks|||Days per week||95% Confidence Interval|Mean
734115|NCT00424528|Secondary|Change in Forced Vital Capacity (FVC) From Study Baseline at Each Assessed Post Dose Timepoint||2 Weeks|||Liters||Standard Deviation|Mean
734116|NCT00424528|Secondary|Change in Inspiratory Capacity From Study Baseline to the 24 Hour Timepoint (Trough) Following 2 Weeks of Dosing|Trough Inspiratory Capacity is defined as the measurement collected approximately 24 hours after the first in clinic double-blind treatment dose at week 0. Change is calculated as Week 2 24 hr post dose IC - Week 0 pre first dose IC.|2 weeks|Total number of subjects in each arm: 76, 80, 78||Liters||95% Confidence Interval|Mean
734117|NCT00424528|Secondary|Time to Onset in Participants Who Achieved a 15% Increase in FEV1 From Visit Predose After 2 Weeks|Analyzed from end of dosing to 12 hours.|2 weeks|Total number of subjects in each arm: 76, 80, 78.||Hours||Full Range|Median
734118|NCT00424528|Secondary|Time to Onset in Participants Who Achieved a 10% Increase in FEV1 From Visit Predose After 2 Weeks|Analyzed from end of dosing to 12 hours.|2 weeks|Total number of subjects in each arm: 76, 80, 78.||Hours||Full Range|Median
734119|NCT00424528|Secondary|Peak Change in FEV1 Over 12 Hours Post Dose From Study Baseline|12 hour peak change in FEV1 is defined as maximum of the post dose changes through the nominal 12 hour assessment.|2 weeks|||Liters||95% Confidence Interval|Mean
734120|NCT00424528|Secondary|Change in FEV1 Percent of Predicted From Study Baseline at Each Assessed Timepoint Post First Dose of Study Medication|Baseline is FEV1 collected prior to first double-blind dose at week 0. Change is defined as Week 0 FEV1 percent predicted - Week 2 pre first dose FEV1 percent predicted.|2 weeks|||Percent of predicted FEV1||Standard Deviation|Mean
734121|NCT00424528|Secondary|Change in FEV1 From Study Baseline at Each Assessed Timepoint Post First Dose of Study Medication|Baseline is FEV1 measurement collected prior to the first double-blind dose at week 0. Change defined as Week 0 FEV1 - Week 2 pre first dose FEV1.|2 weeks|||Liters||Standard Deviation|Mean
734122|NCT00424528|Secondary|Change in FEV1 From Study Baseline to the 24-hour Timepoint (Trough)|Trough FEV1 is defined as the measurement collected approximately 24 hours after the first in-clinic double-blind dose at Week 0. Change is calculated as Week 2 24 hour post first dose FEV1 - Week 0 pre-first dose FEV1.|Following 2 weeks of dosing|Total number of subjects in each arm: 76, 80, 78||Liters||95% Confidence Interval|Mean
734123|NCT00424528|Secondary|Time Normalized Area Under the Change From Study Baseline Curve for FEV1 Over 12-24 Hours (nAUC12-24B)||Following 2 weeks of dosing|Total number of subjects in each arm: 76, 80, 78||Liters||95% Confidence Interval|Mean
734124|NCT00424528|Secondary|Time-normalized Area From Study Baseline Curve for FEV1 Over 0-12 Hours (nAUC0-12B)||0-12 hours following two weeks of dosing|Total number of subjects in each arm: 76, 80, 78||Liters||95% Confidence Interval|Mean
734125|NCT00424528|Primary|Time-normalized Area Under the Change From Study Baseline Curve for Forced Expiratory Volume in One Second (FEV1) Over 24 Hours (nAUC0-24B)||24 hours following two weeks of dosing.|Total number of subjects in each arm: 76, 80, 78||Liters||95% Confidence Interval|Mean
734131|NCT00424593|Other Pre-specified|Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of Patients During the Dose-Blind Extension Phase|Treatment-emergent adverse events during the extension phase reported based on the original treatment group to which the patient was randomized. Dictionary used was MedDRA 11.0.|Week 13 through Week 54|Number of randomized participants who entered the extension phase. Note: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported for all patients who entered extension phase regardless of their original randomization group.||participant|||Number
734132|NCT00424593|Other Pre-specified|Serious Adverse Events During the Dose-Blind Extension Phase|Serious adverse events during the extension phase reported based on the original treatment group to which the patient was randomized. Dictionary used was MedDRA 11.0.|Week 13 though Week 54|Number of randomized participants who entered the extension phase. Note: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported for all patients who entered extension phase regardless of their original randomization group.||participants|||Number
734133|NCT00424593|Secondary|Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Weight||Baseline, Week 13, Week 54|"Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward.
Note: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported per the original randomized group."||kilograms (kg)||Standard Deviation|Mean
734291|NCT00425308|Secondary|Change in Renal Function Assessed by Serum Creatinine at Month 3, Month 6 and Month 12||From Baseline to Month 3, 6, and 12|Intent to Treat Population||µmol/L||Standard Deviation|Mean
734134|NCT00424593|Secondary|Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Blood Pressure||Baseline, Week 13, Week 54|"Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward.
Note: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported per the original randomized group."||mm Hg||Standard Deviation|Mean
734135|NCT00424593|Secondary|Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Pulse Rate||Baseline, Week 13, Week 54|"Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward.
Note: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported per the original randomized group."||beats per minute (bpm)||Standard Deviation|Mean
734136|NCT00424593|Secondary|Laboratory Assessments That Were Statistically Significantly Different Between Treatment Groups in Change From Baseline to Week 13 Endpoint: Uric Acid||Baseline, Week 13|Number of participants with a baseline and at least one non-missing post-baseline value, based on first values at scheduled visits only. Last observation carried forward.||micromole per Liter (μmol/L)||Standard Deviation|Mean
734137|NCT00424593|Secondary|Laboratory Assessments That Were Statistically Significantly Different Between Treatment Groups in Change From Baseline to Week 13 Endpoint: Bicarbonate||Baseline, Week 13|Number of participants with a baseline and at least one non-missing post-baseline value, based on the first values at scheduled visits only. Last observation carried forward.||millimole per Liter (mmol/L)||Standard Deviation|Mean
734138|NCT00424593|Secondary|Change From Baseline to Week 13 Endpoint in Hospital Anxiety and Depression Scale (HADS) Scores|A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.'|Baseline, Week 13|Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward.||units on a scale||Standard Deviation|Mean
734139|NCT00424593|Secondary|Change From Baseline to Week 13 and Week 54 Endpoints in Beck Depression Inventory (BDI-II) Total Scores|A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.|Baseline, Week 13, Week 54|"Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward.
Note: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported per the original randomized group."||units on a scale||Standard Deviation|Mean
734140|NCT00424593|Secondary|Change From Baseline to Week 13 and Week 54 Endpoints in Work Productivity and Activity Impairment Instrument (WPAI) Scores|"WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Higher scores are indicative of greater impairment.
Absenteeism=(Q2/(Q2+Q4))*100
Presenteeism=(Q5/10)*100
Work productivity loss=(Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))x(Q5/10)])*100
Activity Impairment=(Q6/10)*100"|Baseline, Week 13, Week 54|"Number of participants currently being paid to work who had a baseline and at least one non-missing post-baseline value. Last observation carried forward.
Note: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported per the original randomized group."||units on a scale||Standard Deviation|Mean
734141|NCT00424593|Secondary|Change From Baseline to Week 13 Endpoint in EuroQoL Questionnaire - 5 Dimension (EQ-5D)|The EuroQoL Questionnaire – 5 Dimension (EQ-5D) is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows patients to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 is generated for each domain. For each patient, the outcome rating on the 5 domains will be mapped to a single index through an algorithm. The index ranges between 0 and 1, with the higher score indicating a better health state perceived by the patient. Scores presented used the UK Based Index Score.|Baseline, Week 13|Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward.||units on a scale||Standard Deviation|Mean
734142|NCT00424593|Secondary|Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)|The SF-36 Health Status Survey is a generic, health-related scale assessing subjects’ quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). MCS and PCS scores=0-100 (higher scores indicate better health status). Domain scores: general health=5-25; physical functioning=10-30; role-physical=4-8; role-emotional=3-6; social functioning=2-10; bodily pain=2-11; vitality=4-24; mental health=5-30.|Baseline, Week 13|Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward.||units on a scale||Standard Deviation|Mean
734143|NCT00424593|Secondary|Change From Baseline to Week 13 and Week 54 Endpoints in Athens Insomnia Scale|Estimates sleep difficulty. Consists of 8 items rated on a 4-point scale of 0 (no problem at all) to 3 (very serious problem). Total score of the 8-item version ranges from 0-24.|Baseline, Week 13, Week 54|"Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward.
Note: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported per the original randomized group."||units on a scale||Standard Deviation|Mean
734144|NCT00424593|Secondary|Number of Participants Who Responded to Treatment at Week 13 Endpoint Based on 50% Score Reduction Criteria|Response to treatment was defined as at least a 50% reduction of weekly mean score in in Brief Pain Inventory (BPI) Average Pain severity ratings from baseline to endpoint. The number of participants who met this criteria are presented.|Week 13|Number of randomized participants with non-missing response values.||participants|||Number
734145|NCT00424593|Secondary|Number of Participants Who Responded to Treatment at Week 13 Endpoint Based on 30% Score Reduction Criteria|Response to treatment was defined as at least a 30% reduction of weekly mean score in in Brief Pain Inventory (BPI) Average Pain severity ratings from baseline to endpoint. The number of participants who met this criteria are presented.|Week 13|Number of randomized participants with non-missing response values.||participants|||Number
734146|NCT00424593|Secondary|Change From Baseline to Week 13 and Week 54 Endpoints in Clinical Global Impression of Severity (CGI-Severity)|Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Baseline, Week 13, Week 54|"Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward.
Note: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported per the original randomized group."||units on a scale||Standard Deviation|Mean
734147|NCT00424593|Secondary|Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores|BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items.|Baseline, Week 13, Week 54|"Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward.
Note: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported per the original randomized group."||units on a scale||Standard Deviation|Mean
734148|NCT00424593|Secondary|Change From Baseline to Week 13 Endpoint in Weekly Mean of 24-hour Average Pain, Night Pain and Worst Pain by 11-Point Likert Scale|24-hour average pain severity scores recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Patients should complete the electronic diary at bedtime. The 11-point Likert scale will also be used for assessment of night pain and worst pain each day, and evaluated as weekly means. Average interference was calculated as the average of non-missing scores of individual interference items.|Baseline, Week 13|Number of randomized participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward.||units on a scale||Standard Deviation|Mean
734149|NCT00424593|Secondary|Change From Baseline to Week 13 and Week 54 Endpoints in Roland Morris Disability Questionnaire-24 Item (RMDQ-24) Total Score|Roland-Morris questionnaire will be completed by the patient and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the patient is instructed to put a mark next to each appropriate statement. The number of statements marked will be added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability).|Baseline, Week 13, Week 54|"Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward.
Note: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported per the original randomized group."||units on a scale||Standard Deviation|Mean
734150|NCT00424593|Secondary|Patient's Global Impression of Improvement (PGI-I)|A scale that measures the patient's perception of improvement at the time of assessment. The score ranges from 1 (very much better) to 7 (very much worse).|Week 13|Number of participants with at least one non-missing post-baseline value. Last observation carried forward.||units on a scale||Standard Deviation|Mean
734151|NCT00424593|Primary|Change From Baseline to Week 13 in Brief Pain Inventory (BPI), 24-hour Average Pain Scores|A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline, Week 13|Number of participants with baseline and at least one non-missing post-baseline value.||units on a scale||Standard Error|Least Squares Mean
734152|NCT00424619|Secondary|Functional Assessment Using the Two Minute Walk Test (2MWT)After 3 Months|The 2MWT was collected for patients who attended the 3-month clinic appointment by study coordinators or for patients who attended rehabilitation, it was abstracted from their charts. The 2MWT test was given in a carpeted corridor and the subject was instructed to wear regular footwear and to use their customary walking aid. The distance the participant could comfortably walk in two-minutes (without physical assistance) was measured in metres.|3 months|The number of participants who completed the 2WT is lower than the number of participants who completed the primary outcome at this time point. Not everyone chose to complete the functional 2WT test at this time point.||meters||Full Range|Mean
734153|NCT00424619|Primary|Creatinine|Baseline blood samples were drawn in-hospital. In additional creatinine was accessed at baseline.|Baseline|||µmol/L||Standard Deviation|Mean
734154|NCT00424619|Primary|Hemoglobin|Baseline blood samples were drawn in-hospital. In additional hemoglobin was accessed at baseline.|Baseline|||g/L||Standard Deviation|Mean
734155|NCT00424619|Primary|Alkaline Phosphatase|Baseline blood samples were drawn in-hospital. In additional Alkaline Phosphatase was accessed at baseline.|Baseline|||U/L||Standard Deviation|Mean
734156|NCT00424619|Primary|Phosphate|Baseline blood samples were drawn in-hospital. In additional phosphate was accessed at baseline.|Baseline|||mmol/L||Standard Deviation|Mean
734157|NCT00424619|Primary|Calcium|Baseline blood samples were drawn in-hospital. In additional Calcium was accessed at baseline and approximately 4 weeks.|Baseline, 4 weeks|||mmol/L||Standard Deviation|Mean
734158|NCT00424619|Primary|Parathyroid Hormone (PTH)|Baseline blood samples were drawn in-hospital. In additional PTH was accessed at baseline.|Baseline|||pmol/L||Standard Deviation|Mean
734159|NCT00424619|Primary|25-hydroxyvitamin D3 (25-OHD)|Serum 25-hydroxyvitamin D3 (25-OHD) was measured at baseline, at discharge from hospital (approximately 4-weeks), and at a follow-up study visit at approximately 3-months.Baseline and 4-week blood samples were drawn in-hospital; venipunctures performed at 3-months were either in-hospital (if patient remained in acute care or rehabilitation) or at the out-patient clinic visit.Serum 25-OHD was analyzed with the DiaSorin, 25-hydroxyvitamin D radioimmunoassay (Stillwater, Minnesota 55082-0285, U.S.A) at the central laboratory with the exception of 3 patients (data analyzed at other laboratories).|Baseline, 4 weeks and 3 months|Baseline data (n=59) was missing for two participants, and four outliers with 25-OHD taken at 6, 10 or 12 days were not included. 4-week data (n=50) was missing for 13 participants, and two outliers with 25-OHD taken at <13 days were not included. 3-month data (n=47) was missing for 18 participants.||nmol/L||95% Confidence Interval|Mean
734187|NCT00424775|Primary|Number of Participants With a Dose Limited Toxicity at First Cycle|Dose Limited Toxicity = Drug-related side effects that are serious enough to prevent an increase in dose or level of that treatment.|25 Days (first cycle)|All participants who received vorinostat 300 mg once daily.||Participants|||Number
734160|NCT00424619|Secondary|Functional Assessment Using the Timed Up and Go (TUG) Test After 3 Months|The Timed Up and Go (TUG) was collected for patients who attended the 3-month clinic appointment by study coordinators or for patients who attended the rehabilitation unit this is routinely collected and was abstracted from chart. The TUG was conducted using a standard armchair and a line marked 3-metres from the chair. Participants were given the following instructions (no physical assistance was given): “Rise from the chair, walk to the line on the floor, turn, return to the chair and sit down again”. Scores are measured as time in seconds to complete the task.|3 months|The number of participants who completed the TUG test is lower than the number of participants who completed the primary outcome at this time point. Not everyone chose to complete the functional TUG test at this time point.||seconds||Full Range|Mean
734161|NCT00424632|Secondary|Aurora Gene Somatic Mutations/Amplification and Pathway Genes in Tumor Tissue|Percentage of aurora gene somatic mutations/amplification and pathway genes in relation to clinical response. Responses include CR: disappearance of all target lesions; PR: ≥30% decrease in sum of longest dimensions (LD) of target lesions referencing baseline sum LD; Progressive disease: ≥20% increase in sum LD of target lesions from smallest sum LD recorded since Tx start or appearance of ≥1 new lesions; Stable disease: neither sufficient shrinkage to=PR nor sufficient increase to=PD during first 6 weeks after Tx start referencing smallest sum LD since Tx start.|Schedule A Cycle 1 or Cycle 2 /Day 4 or Day 5, Schedule B Cycle 1/Day 9 or Day 10 (each cycle=21 days)|Data was not summarized as the development of the compound was discontinued.||percentage of cells|||Number
734162|NCT00424632|Secondary|Germ Line Polymorphism of Candidate Genes Targeted by PF-03814735|Percentage of germ line polymorphism cell expression in relation to clinical response. Responses include CR: disappearance of all target lesions; PR: ≥30% decrease in sum of LD of target lesions referencing baseline sum LD; Progressive disease: ≥20% increase in sum LD of target lesions from smallest sum LD recorded since Tx start or appearance of ≥1 new lesions; Stable disease: neither sufficient shrinkage to=PR nor sufficient increase to=PD during first 6 weeks after Tx start referencing smallest sum LD since Tx start.|Schedule A Cycle 1 or Cycle 2 /Day 4 or Day 5, Schedule B Cycle 1/Day 9 or Day 10 (each cycle=21 days)|Data was not summarized as the development of the compound was discontinued.||percentage of cells|||Number
734163|NCT00424632|Secondary|Duration of Response|Duration of responses based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.|Every 2 cycles (each cycle=21 days) until disease progression or participant discontinuation; maximum follow-up was from baseline up to 12 cycles|Data was not summarized as the development of the compound was discontinued.||months|||Number
734164|NCT00424632|Secondary|Time to Progression|Time to Progression defined as the time from the date of enrollment to the date progressive disease first reported. If tumor progression data included more than 1 date, the first date was to be used. TTP = (first date of tumor progression – date of enrollment + 1). Progressive disease: ≥20% increase in sum LD of target lesions from smallest sum LD recorded since treatment start or appearance of ≥1 new lesions.|Baseline, every 2 cycles (each cycle=21 days) until disease progression or participant discontinuation; maximum follow-up was from baseline up to 12 cycles|Data was not summarized as the development of the compound was discontinued.||months|||Number
734165|NCT00424632|Secondary|Number of Participants With Objective Tumor Response|Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.|Every 2 cycles (each cycle=21 days) until disease progression or participant discontinuation; maximum follow-up was from baseline up to 12 cycles|Data was not summarized as the development of the compound was discontinued.||participants|||Number
734166|NCT00424632|Secondary|Target Modulation by Phosphohistone H3 (pH3) Expression in Tumor Tissue (IHC)|pH3 expression is a method to enable the quantification of the proliferative potential of tumor cells. Post-dose tumor tissue sampling occurred after FDG-PET. Biopsies were not to be taken from lesions which were used for PET analysis and were to be taken between 1 and 6 hours after study drug administration. Collected in the expanded MTD cohort only (≥ 10 participants in Sch A 80 mg and Sch B 50 mg groups).|Schedule A Cycle 1 or Cycle 2 /Day 4 or Day 5, Schedule B Cycle 1/Day 9 or Day 10|Data was not summarized as the development of the compound was discontinued.||percentage of cells||Standard Deviation|Mean
734167|NCT00424632|Secondary|Summary of Tumor Metabolism Assessed by Positron Emission Tomography With F-18-fluorodeoxyglucose (FDG-PET)|FTD-PET measured as standardized uptake volume (SUV) values corrected for lean body mass. Change from baseline categorized according to European Organization for Research and Treatment for Cancer (EORTC) criteria: Partial Metabolic Response (PMR): SUV value during treatment <75 percent (%) of baseline value; Progressive Metabolic Disease (PMD): SUV value during treatment >125% of baseline value; Stable Metabolic Disease (SMD): change in SUV value between PMR and PMD. Collected in the expanded MTD cohort only (≥ 10 participants in Sch A 80 mg and Sch B 50 mg groups).|Baseline (Schedule A or Schedule B Day -7) and Schedule A Cycle 1/Day 3 or Day 4, Schedule B Cycle 1/Day 8 or 9|Data was not summarized as the development of the compound was discontinued.||percent change||Standard Deviation|Mean
734168|NCT00424632|Secondary|Urine Pharmacokinetics|Urine PK for quantification of unchanged PF-03814375 and any identified metabolites. 24-hour urine collection at 8-hour intervals after the morning dose (Schedule [Sch] A Day 4, Sch B Day 9; last sample collected just prior to the morning dose on Sch A Day 5 or Sch B Day 10 in the expanded maximum tolerated dose (MTD) cohort only (≥ 10 participants in Sch A 80 mg and Sch B 50 mg groups). The lower limit of quantification (LLOQ) was 1 nanogram per milliliter (ng/mL). Clinical specimens with concentrations below the LLOQ were to be reported as below the limited of quantification (BLQ) 1 ng/mL.|Schedule A Cycle 1/Day 4, Schedule B Cycle 1/Day 9: pre-dose, 0.5, 1, 2, 4, 6, 10, and 24 hours post-dose|Data was not summarized as the development of the compound was discontinued.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
734188|NCT00424827|Secondary|Toxicity Associated With This Regimen.||1-Year|||participants|||Number
734189|NCT00424827|Secondary|Overall Survival||Up to 2 years|||months||95% Confidence Interval|Median
734169|NCT00424632|Secondary|Terminal Half-life (t 1/2)|Terminal half-life (serum decay half-life) is the time measured for the serum concentration to decrease by one half.|Schedule A Cycle 1/Day 4, Schedule B Cycle 1/Day 9: pre-dose, 0.5, 1, 2, 4, 6, 10, and 24 hours post-dose|Half-life (t ½) was not reported for multiple-dose data since the 24-hour sampling period was not long enough to adequately characterize t ½.||hours||Standard Deviation|Mean
734170|NCT00424632|Secondary|Observed Serum Accumulation Ratio (Rac)|Rac was the ratio of Schedule B Cycle 1/Day 9 to Day -5 (Day 9 AUCτ to Day -5 AUCτ).|Schedule B Day-5: pre-dose, 0.5, 1, 2, 4, 6, 10, 24, 32, 48, and 72 hours post-dose, Schedule B Cycle 1/Day 9: pre-dose, 0.5, 1, 2, 4, 6, 10, and 24 hours post-dose|PK parameter analysis set. N=number of participants in the indicated population contributing to the mean.||ratio||Geometric Coefficient of Variation|Geometric Mean
734171|NCT00424632|Secondary|Minimum Observed Serum Trough Concentration (Cmin)|Cmin defined as the lowest serum concentration observed during the dosing interval.|Schedule A Cycle 1/Day 4, Schedule B Cycle 1/Day 9: pre-dose, 0.5, 1, 2, 4, 6, 10, and 24 hours post-dose|PK parameter analysis set||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
734172|NCT00424632|Secondary|Area Under the Serum Concentration Time Profile From Time 0 to Time Tau (τ), the Dosing Interval, Where τ = 24 Hours (AUCτ).||Schedule A Cycle 1/Day 4, Schedule B Cycle 1/Day 9: pre-dose, 0.5, 1, 2, 4, 6, 10, and 24 hours post-dose|PK parameter analysis set||mcg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
734173|NCT00424632|Secondary|Area Under the Serum Concentration Time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast)|Area under the serum concentration time-curve from zero to the last measured concentration.|Schedule A Cycle 1/Day 4, Schedule B Cycle 1/Day 9: pre-dose, 0.5, 1, 2, 4, 6, 10, and 24 hours post-dose|Data was not summarized as the development of the compound was discontinued.||mcg*hr/mL||Full Range|Median
734174|NCT00424632|Secondary|Time for Maximum Observed Serum Concentration (Tmax)||Schedule A Cycle 1/Day 4, Schedule B Cycle 1/Day 9: pre-dose, 0.5, 1, 2, 4, 6, 10, and 24 hours post-dose|PK parameter analysis set||hours||Full Range|Median
734175|NCT00424632|Secondary|Maximum Observed Serum Concentration (Cmax)||Schedule A Cycle 1/Day 4, Schedule B Cycle 1/Day 9: pre-dose, 0.5, 1, 2, 4, 6, 10, and 24 hours post-dose|Pharmacokinetic (PK) parameter analysis set: Enrolled participants who received at least 1 dose of study treatment who had at least 1 of the PK parameters of interest estimated in at least 1 treatment period.||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
734176|NCT00424632|Primary|Number of Participants With First Cycle Dose Limiting Toxicities (DLTs) Graded According to Common Terminology Criteria Adverse Events (CTCAE), Version 3|DLT defined as any of the following during the first cycle of treatment and attributable to PF-03814735: Grade (Gr) 4 neutropenia (absolute neutrophil count [ANC] <500 cells/mm^3) for >7 days or febrile neutropenia (ANC <1000/mm^3, fever ≥38 degrees Celsius; neutropenic infection (ANC <1000/mm^3); Gr 4 thrombocytopenia (platelets <25,000 cells/mm^3); ≥Gr 3 nausea, vomiting, or diarrhea, despite optimal antiemetic, anti-diarrheal support; ≥20% decrease in left ventricular ejection fraction compared to baseline; other non-hematological toxicity; any Gr ≥3 adverse event; or failure to recover.|Day 1 up to Day 21 of first cycle|Safety population: Same as the As-treated population, defined as all patients enrolled in the study that received at least 1 dose of the study medication.||participants|||Number
734177|NCT00424645|Primary|Patient Response Rate (Percentage)|Response rate defined as proportion of patients that clear methotrexate (MTX) at 15 min and 24-hour post infusion of study drug, Glucarpidase (Voraxaze) to total patient number. Serum MTX levels (standard methods and mass spectrometry) at 15 minutes, 24 hours, or daily until MTX clearance defined as serum MTX level <0.1 µmol/L.|Study period 2 years|Analysis was to be per protocol, low accrual and early termination led too few responses for evaluation.|||||
734178|NCT00424749|Primary|Participants With Remission of Renal Disease Activity at 3 Months|Remission of renal disease activity was indicated by stable or falling creatinine, absence of active urinary sediment AND reduction of oral prednisone dose to less than 50% of average dose of preceding 3 months or less than 10 mg/day (whichever smaller)|3 months after beginning of remission induction regimen|||participants|||Number
734179|NCT00424749|Secondary|Participants With Normalization of Eosinophil Count at 6 Months|Normalization of eosinophil counts was defined as total eosinophil counts <1.5 x 10^9/L.|6 months after beginning of remission induction regimen|||participants|||Number
734180|NCT00424762|Secondary|Percentage of Patients Developing New or Worsening Peripheral Edema|clinical evaluation of peripheral edema by physical exam at each study visit by a cardiologist using standard clinical severity scale 0-4, with new/worsening edema defined as any edema in patients with none at baseline, OR increase in severity by 2 or more points in patients with edema at baseline|6 months|||percentage of patients|||Number
734181|NCT00424762|Primary|Peak Oxygen Uptake (VO2)|measurement of peak oxygen uptake (VO2peak) during treadmill exercise, in units of milliliters of oxygen per kilogram of fat-free mass per minute|6 months|completed baseline and end-of-study cardiopulmonary exercise test||ml O2 uptake/kg fat-free mass/minute||Standard Deviation|Mean
734182|NCT00424762|Secondary|Intra-myocardial Triglyceride Content Using in Vivo Magnetic Resonance Spectroscopy at 6 Months|proton magnetic resonance spectroscopy determination of intra-myocardial triglyceride content at baseline and after 6 months, with triglyceride quantified analyzing fat and water signals assuming monoexponential signal decay and expressed as a percentage of fat-to-water (%)|6 months|analysis limited to those with interpretable imaging data at baseline and end of study||percentage of fat-to-water; %||Standard Deviation|Mean
734183|NCT00424775|Secondary|Maximum Concentration (Cmax) at Day 5|Maximum Concentration (Cmax) = the maximum plasma concentration of the drug|Day 5|Participants who received vorinostat 300 mg once daily and had Pharmacokinetics Data on Day 5.||µM||Full Range|Mean
734184|NCT00424775|Secondary|Maximum Concentration (Cmax) at Day 4|Maximum Concentration (Cmax) = the maximum plasma concentration of the drug|Day 4|Participants who received vorinostat 300 mg once daily and had Pharmacokinetics Data on Day 4.||µM||Full Range|Mean
734185|NCT00424775|Secondary|Area Under the Curve (AUC(0-24 hr)) at Day 5|Area Under the Curve (AUC (0-24 hr)) = Area under the plasma concentration versus time curve (AUC) from time zero to 24 hour.|Day 5|Participants who received vorinostat 300 mg once daily and had Pharmacokinetics Data on Day 5.||µM hr||Full Range|Mean
734186|NCT00424775|Secondary|Area Under the Curve (AUC(0-24 hr)) at Day 4|Area Under the Curve (AUC (0-24 hr)) = Area under the plasma concentration versus time curve (AUC) from time zero to 24 hour.|Day 4|Participants who received vorinostat 300 mg once daily and had Pharmacokinetics Data on Day 4.||µM hr||Full Range|Mean
734192|NCT00424827|Primary|Progression-free Survival of Patients With Locally Advanced Pancreatic Cancer Treated With Concurrent Gemcitabine, 5-FU, Cetuximab and External Beam Radiation Therapy.|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|1-year|Must have histologic confirmation of pancreatic adenocarcinoma with measurable disease per RECIST criteria, with locoregional disease not amenable to surgery were enrolled: based on(1) size of the tumor, 5cm; (2) lymph nodes; (3) vascular involvement or impingement on major vessels; and (4) invasion into the adjacent structures.||months||95% Confidence Interval|Median
734193|NCT00425061|Other Pre-specified|Number of Participants With Laboratory Test Abnormalities of Potential Clinical Importance - Stage 2/3|Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, platelet count, white blood cell count, total neutrophils, eosinophils); hepatobiliary biochemistry: ALT, AST, alkaline phosphatase, total bilirubin, GGT, total LDH; renal function tests: BUN, creatinine, creatinine kinase, uric acid, albumin; electrolytes: sodium, potassium, calcium, magnesium, phosphorus; coagulation: prothrombin time and partial thromboplastin time; glucose: fasting, non-fasting; lipid profile: total cholesterol, triglycerides.|Baseline up to Day 112|mITT population (Stage 2 and 3) included all randomized participants who received at least 1 dose administration of the test article in Stage 2 and 3. LOCF method was used to impute missing values.||participants|||Number
734194|NCT00425061|Other Pre-specified|Number of Participants With Laboratory Test Abnormalities of Potential Clinical Importance - Stage 1|Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, platelet count, white blood cell count, total neutrophils, eosinophils); hepatobiliary biochemistry: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, total bilirubin, gamma glutamyl transferase (GGT), total lactate dehydrogenase (LDH); renal function tests: blood urea nitrogen (BUN), creatinine, creatinine kinase, uric acid, albumin; electrolytes: sodium, potassium, calcium, magnesium, phosphorus; coagulation: prothrombin time and partial thromboplastin time; glucose: fasting, non-fasting; lipid profile: total cholesterol, triglycerides.|Baseline up to Day 112|mITT population (Stage 1) included all randomized participants who received at least 1 dose administration of the test article in Stage 1.||participants|||Number
734195|NCT00425061|Other Pre-specified|Number of Participants With Injection Site Reaction - Stage 2/3||Baseline up to Day 112|mITT population (Stage 2 and 3) included all randomized participants who received at least 1 dose administration of the test article in Stage 2 and 3.||participants|||Number
734196|NCT00425061|Other Pre-specified|Number of Participants With Injection Site Reaction - Stage 1||Baseline up to Day 112|mITT population (Stage 1) included all randomized participants who received at least 1 dose administration of the test article in Stage 1.||participants|||Number
734197|NCT00425061|Other Pre-specified|Number of Participants With Electrocardiogram (ECG) Abnormalities of Potential Clinical Concern - Stage 2/3|Clinically significant ECG findings included - heart rate: >15 bpm increase from baseline and >=120 bpm, PR interval: >=20 msec change from baseline and >=220 msec: QRS interval: >=120 msec: QTc interval: >450 msec for males and >470 msec for females.|Baseline up to Day 112|mITT population (Stage 2 and 3) included all randomized participants who received at least 1 dose administration of the test article in Stage 2 and 3.||participants|||Number
734198|NCT00425061|Other Pre-specified|Number of Participants With Electrocardiogram (ECG) Abnormalities of Potential Clinical Concern - Stage 1|Clinically significant ECG findings included - heart rate: >15 bpm increase from baseline and >=120 bpm, PR interval: >=20 millisecond (msec) change from baseline and >=220 msec: QRS interval: >=120 msec: corrected QT (QTc) interval: >450 msec for males and >470 msec for females.|Baseline up to Day 112|mITT population (Stage 1) included all randomized participants who received at least 1 dose administration of the test article in Stage 1.||participants|||Number
734199|NCT00425061|Other Pre-specified|Number of Participants With Clinically Important Changes in Physical Findings - Stage 2/3|Physical examination included examination of general appearance, skin, head, ears, eyes, nose, throat, heart, lungs, breasts, abdomen, external genitalia, extremities, neurological exam, back/spine and lymph nodes.|Baseline up to Day 112|mITT population (Stage 2 and 3) included all randomized participants who received at least 1 dose administration of the test article in Stage 2 and 3.||participants|||Number
734200|NCT00425061|Other Pre-specified|Number of Participants With Clinically Important Changes in Physical Findings - Stage 1|Physical examination included examination of general appearance, skin, head, ears, eyes, nose, throat, heart, lungs, breasts, abdomen, external genitalia, extremities, neurological exam, back/spine and lymph nodes.|Baseline up to Day 112|mITT population (Stage 1) included all randomized participants who received at least 1 dose administration of the test article in Stage 1.||participants|||Number
734201|NCT00425061|Other Pre-specified|Number of Participants With Vital Sign Abnormalities of Potential Clinical Importance - Stage 2/3|Criteria for PCI vital sign abnormalities- heart rate: >15 bpm increase from baseline and >=120 bpm, >15 bpm decrease from baseline and <=45 bpm: SBP: >=20 mmHg increase from baseline and >=160 mmHg, >=20 mmHg decrease from baseline and <=90 mmHg: DBP: of >=15 mmHg increase from baseline and >=100 mmHg, >=15 mmHg decrease from baseline and <=50 mmHg, oral temperature <35 or >38.3 degrees centigrade: respiratory rate: <10 or >25 breaths/minute: body weight: >=7% increase or decrease from baseline.|Baseline up to Day 112|mITT population (Stage 2 and 3) included all randomized participants who received at least 1 dose administration of the test article in Stage 2 and 3.||participants|||Number
734202|NCT00425061|Other Pre-specified|Number of Participants With Vital Sign Abnormalities of Potential Clinical Importance Stage 1|Criteria for potentially clinically important (PCI) vital sign abnormalities- heart rate: greater than (>) 15 beats per minute (bpm) increase from baseline and greater than or equal to (>=) 120 bpm, >15 bpm decrease from baseline and less than or equal to (<=) 45 bpm: systolic blood pressure (SBP): >=20 millimeter of mercury (mmHg) increase from baseline and >=160 mmHg, >=20 mmHg decrease from baseline and <=90 mmHg: diastolic blood pressure (DBP): of >=15 mmHg increase from baseline and >=100 mmHg, >=15 mmHg decrease from baseline and <=50 mmHg, oral temperature <35 or >38.3 degrees centigrade: respiratory rate: <10 or >25 breaths/minute: body weight: >=7% increase or decrease from baseline.|Baseline up to Day 112|mITT population (Stage 1) included all randomized participants who received at least 1 dose administration of the test article in Stage 1.||participants|||Number
734205|NCT00425061|Secondary|Log 10-transformed Serum Total Immunoglobulin E (IgE) Levels - Stage 2/3|Log 10-transformed serum total IgE levels were expressed in Log-10 International units/milliliter (IU/mL).|Baseline, Day 28, 56, 84, 112|"mITT population (Stage 2 and 3) included all randomized participants who received at least 1 dose administration of the test article in Stage 2 and 3. LOCF method was used to impute missing values. n signifies participants evaluated for this measure at the specified time point for each arm."||log-10 IU/mL||Standard Deviation|Mean
734206|NCT00425061|Secondary|Log 10-transformed Serum Total Immunoglobulin E (IgE) Levels - Stage 1|Log 10-transformed serum total IgE levels were expressed in Log-10 International units/milliliter (IU/mL).|Baseline, Day 28, 56, 84, 112|"mITT population (Stage 1) included all randomized participants who received at least 1 dose of test article in Stage 1. LOCF method was used to impute missing values.'N' (Number of Participants Analyzed) signifies participants evaluable for this measure.n signifies participants evaluated for this measure at the specified time point for each arm."||log-10 IU/mL||Standard Deviation|Mean
734207|NCT00425061|Secondary|Blood Eosinophils Levels - Stage 2/3||Baseline, Day 8, 28, 56, 84, 112|mITT population (Stage 2 and 3) included all randomized participants who received at least 1 dose administration of the test article in Stage 2 and 3. LOCF method was used to impute missing values.||10^9 cells/L||Standard Deviation|Mean
734208|NCT00425061|Secondary|Blood Eosinophils Levels - Stage 1||Baseline, Day 8, 28, 56, 84, 112|mITT population (Stage 1) included all randomized participants who received at least 1 dose administration of the test article in Stage 1. LOCF method was used to impute missing values.||10^9 cells per liter (cells/L)||Standard Deviation|Mean
734209|NCT00425061|Secondary|Forced Mid-Expiratory Flow Rate 25 Percent (%) to 75% (FEF25-75) - Stage 2/3|FEF25-75 is the average expiratory flow over the middle half of the FVC. FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.|Baseline, Day 8, 28, 56, 84, 112|Data for this outcome measure was not analyzed as the study was stopped early and sponsor’s decision to analyze only safety and key efficacy outcomes.|||||
734210|NCT00425061|Secondary|Forced Mid-Expiratory Flow Rate 25 Percent (%) to 75% (FEF25-75) - Stage 1|FEF25-75 is the average expiratory flow over the middle half of the FVC. FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.|Baseline, Day 8, 28, 56, 84, 112|Data for this outcome measure was not analyzed as the study was stopped early and sponsor’s decision to analyze only safety and key efficacy outcomes.|||||
734211|NCT00425061|Secondary|Forced Vital Capacity (FVC) - Stage 2/3|FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.|Baseline, Day 8, 28, 56, 84, 112|Data for this outcome measure was not analyzed as the study was stopped early and sponsor’s decision to analyze only safety and key efficacy outcomes.|||||
734212|NCT00425061|Secondary|Forced Vital Capacity (FVC) - Stage 1|FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.|Baseline, Day 8, 28, 56, 84, 112|Data for this outcome measure was not analyzed as the study was stopped early and sponsor’s decision to analyze only safety and key efficacy outcomes.|||||
734213|NCT00425061|Secondary|Mean Number of Puffs of Rescue Medication Used - Stage 2/3|The rescue medication taken for needed symptoms was a SABA inhaler. Albuterol, 90 mcg/puff, was recommended for use.|Day 8, 28, 56, 84, 89, 91, 94, 98, 112|Data for this outcome measure was not analyzed as the study was stopped early and sponsor’s decision to analyze only safety and key efficacy outcomes.|||||
734214|NCT00425061|Secondary|Mean Number of Puffs of Rescue Medication Used - Stage 1|The rescue medication taken for needed symptoms was a short acting beta agonist (SABA) inhaler. Albuterol, 90 microgram (mcg)/puff, was recommended for use.|Day 8, 28, 56, 84, 89, 91, 94, 98, 112|Data for this outcome measure was not analyzed as the study was stopped early and sponsor’s decision to analyze only safety and key efficacy outcomes.|||||
734215|NCT00425061|Secondary|Percentage of Participants Who Required Treatment With Systemic Steroids for Clinical Exacerbation of Asthma - Stage 2/3||Baseline up to Day 112|mITT population (Stage 2 and 3) included all randomized participants who received at least 1 dose administration of the test article in Stage 2 and 3. LOCF method was used to impute missing values.||percentage of participant|||Number
734216|NCT00425061|Secondary|Percentage of Participants Who Required Treatment With Systemic Steroids for Clinical Exacerbation of Asthma - Stage 1||Baseline up to Day 112|mITT population (Stage 1) included all randomized participants who received at least 1 dose administration of the test article in Stage 1. LOCF method was used to impute missing values.||percentage of participants|||Number
734217|NCT00425061|Secondary|Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score at Day 8, 28, 56, 84 and 112 - Stage 2/3|ACQ-5 was a 5-item participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing). Participants were asked to recall how their asthma had been during the previous week. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score was the mean of the responses. Mean scores of =< 0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score >= 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful.|Baseline, Day 8, 28, 56, 84, 112|mITT population (Stage 2 and 3) included all randomized participants who received at least 1 dose administration of the test article in Stage 2 and 3. LOCF method was used to impute missing values.||units on a scale||Standard Deviation|Mean
734218|NCT00425061|Secondary|Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score at Day 8, 28, 56, 84 and 112 - Stage 1|ACQ-5 was a 5-item participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing). Participants were asked to recall how their asthma had been during the previous week. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score was the mean of the responses. Mean scores of less than or equal to (=<) 0.75 indicate well-controlled asthma, scores between 0.76 and less than (<) 1.5 indicate partly controlled asthma, and a score greater than or equal to (>=) 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful.|Baseline, Day 8, 28, 56, 84, 112|mITT population (Stage 1) included all randomized participants who received at least 1 dose administration of the test article in Stage 1. LOCF method was used to impute missing values.||units on a scale||Standard Deviation|Mean
734219|NCT00425061|Secondary|Change From Baseline in Airway Hyper-reactivity at Day 28 and 112|Airway hyper-reactivity was assessed using provocative concentration 20 (PC20). PC20 was the concentration of methacholine at which participants had 20 percent (%) decrease in FEV1. Results for PC20 were summarized together for all participants who received any dose of IMA-638 and for all participants who received placebo during any stage of the study as per investigator's discretion.|Baseline, Day 28, 112|mITT population included all randomized participants who received at least 1 dose administration of the test article. LOCF method was used to impute missing values. 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||milligram per milliliter (mg/mL)||Standard Deviation|Geometric Mean
734220|NCT00425061|Secondary|Change From Baseline in Pre-beta-agonist Forced Expiratory Volume in 1 Second (FEV1) at Day 8, 28, 56, 84 and 112 - Stage 2/3|FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FEV1 was obtained from spirometry, performed before study treatment administration. Participants performed the test in triplicate at each visit and the best of the 3 values was selected.|Baseline, Day 8, 28, 56, 84, 112|mITT population (Stage 2 and 3) included all randomized participants who received at least 1 dose administration of the test article in Stage 2 and 3. LOCF method was used to impute missing values.||liter||Standard Deviation|Mean
734221|NCT00425061|Secondary|Change From Baseline in Pre-beta-agonist Forced Expiratory Volume in 1 Second (FEV1) at Day 8, 28, 56, 84 and 112 - Stage 1|FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FEV1 was obtained from spirometry, performed before study treatment administration. Participants performed the test in triplicate at each visit and the best of the 3 values was selected.|Baseline, Day 8, 28, 56, 84, 112|mITT population (Stage 1) included all randomized participants who received at least 1 dose administration of the test article in Stage 1. LOCF method was used to impute missing values.||liter||Standard Deviation|Mean
734222|NCT00425061|Primary|Change From Baseline in Morning (Ante Meridiem) Peak Expiratory Flow Rate (AM PEFR) at Day 112 - Stage 2/3|The PEFR is a participant’s maximum speed of expiration, as measured with a peak flow meter. All participants were issued with the peak flow meter and instructed to perform the activity in triplicate in the morning prior to taking bronchodilator. The best among the 3 readings was selected.|Baseline, Day 112|"mITT population (Stage 2 and 3) included all randomized participants who received at least 1 dose administration of the test article in Stage 2 and 3. LOCF method was used to impute missing values. n signifies those participants who were evaluated for this measure at the specified time point for each arm."||L/min||Standard Deviation|Mean
734223|NCT00425061|Primary|Change From Baseline in Morning (Ante Meridiem) Peak Expiratory Flow Rate (AM PEFR) at Day 112 - Stage 1|The PEFR is a participant’s maximum speed of expiration, as measured with a peak flow meter. All participants were issued with the peak flow meter and instructed to perform the activity in triplicate in the morning prior to taking bronchodilator. The best among the 3 readings was selected.|Baseline, Day 112|mITT population (Stage 1) included all randomized participants who received at least 1 dose administration of the test article in Stage 1. Last observation carried forward (LOCF) method was used to impute missing values.||liter per minute (L/min)||Standard Deviation|Mean
734224|NCT00425100|Secondary|Treated Subjects Reporting Satisfaction With Their Current OAB Treatment (Supportive Analysis)|Number of participants who responded satisfied = (very satisfied or somewhat satisfied) or dissatisfied = (somewhat dissatisfied or very dissatisfied) to the treatment satisfaction question at Week 12 in the safety set.|Week 12|Subjects in safety set included subjects who took at least one dose of study drug. Missing responses to the Treatment Satisfaction Question at Week 12 were imputed as not satisfied for calculating the most conservative treatment satisfaction.||participants|||Number
734225|NCT00425100|Secondary|Sum Rating on the Urinary Sensation Scale|The sum rating per 24 hours was calculated as the mean rating score on the Urinary Sensation Scale multiplied by the mean number of micturitions per 24 hours at that visit. The scale ranges from 1 “no feeling of urgency” to 5 “unable to hold; leak urine.”|Baseline and Week 12|Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12 (LOCF). The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.||scores on a scale||Standard Deviation|Mean
734226|NCT00425100|Secondary|"Satisfaction With OAB Control Module of Overactive Bladder (OAB) Treatment Satisfaction Questionnaire (TSQ) (OAB-S)"|Module coded on scale (1-very satisfied to 5-very dissatisfied). Coding reversed algorithmically & results transformed: total score range 0-100. Higher final response value associated with better satisfaction. Satisfied on TSQ = very or somewhat satisfied; Not satisfied on TSQ =very or somewhat dissatisfied or neither dissatisfied nor satisfied.|Week 12|Population included subjects in FAS (described above) with non-missing values on OAB-S at Week 12, referred to in table below as All Subjects. Summary was presented for All Subjects and 2 subgroups, based on categorization for treatment satisfaction question used in primary endpoint assessing satisfaction.||scores on a scale||Standard Deviation|Mean
734227|NCT00425100|Secondary|Overactive Bladder Questionnaire (OAB-q) - Symptom Bother Scale|Each item rated by subject on a Likert scale 1 (least symptom bother) to 6 (most symptom bother). Raw scores were transformed to a score from 0 to 100. Once transformed, higher scores represent less favorable outcome.|Baseline and Week 12|Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12. The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.||scores on a scale||Standard Deviation|Mean
734228|NCT00425100|Secondary|Overactive Bladder Questionnaire (OAB-q) - Total Health Related Quality of Life (HRQL) Scale|Each item rated by subject on a Likert scale 1 (most favorable) to 6 (least favorable). Raw scores were transformed to a score from 0 to 100. Once transformed, higher scores represent more favorable outcome.|Baseline and Week 12|Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12. The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.||scores on a scale||Standard Deviation|Mean
734292|NCT00425308|Primary|Change in the Glomerular Filtration Rate Estimated by Iohexol Plasma Clearance 12 Months After Randomization Between the 2 Groups of Patients Who Completed Trial|Primary efficacy endpoint: between treatment analysis of change in iohexol plasmatic clearance (mL/min) from baseline to Month 12 (M12)|From Baseline to Month 12|Intent to Treat (ITT) Population: completed patients||(mL/min)||Standard Error|Least Squares Mean
734229|NCT00425100|Secondary|Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Social Interaction Domain|Each item rated by subject on a Likert scale 1 (most favorable) to 6 (least favorable). Raw scores were transformed to a score from 0 to 100. Once transformed, higher scores represent more favorable outcome.|Baseline and Week 12|Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12. The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.||scores on a scale||Standard Deviation|Mean
734230|NCT00425100|Secondary|Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Sleep Domain|Each item rated by subject on a Likert scale 1 (most favorable) to 6 (least favorable). Raw scores were transformed to a score from 0 to 100. Once transformed, higher scores represent more favorable outcome.|Baseline and Week 12|Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12. The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.||scores on a scale||Standard Deviation|Mean
734231|NCT00425100|Secondary|Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Coping Domain|Each item rated by subject on a Likert scale 1 (most favorable) to 6 (least favorable). Raw scores were transformed to a score from 0 to 100. Once transformed, higher scores represent more favorable outcome.|Baseline and Week 12|Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12. The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.||scores on a scale||Standard Deviation|Mean
734232|NCT00425100|Secondary|Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Concern Domain|Each item rated by subject on a Likert scale 1 (most favorable) to 6 (least favorable). Raw scores were transformed to a score from 0 to 100. Once transformed, higher scores represent more favorable outcome.|Baseline and Week 12|Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12. The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.||scores on a scale||Standard Deviation|Mean
734233|NCT00425100|Secondary|Urgency Perception Scale (UPS) at Week 12 Relative to Baseline (Categorical Change)|Improvement: positive score change; No improvement: zero or negative score change|Baseline and Week 12|Subjects in the Full Analysis Set (FAS) with non-missing change from baseline to Week 12 (LOCF). The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.||participants|||Number
734234|NCT00425100|Secondary|Urgency Perception Scale (UPS)|UPS scores range from 0 (“I am usually not able to hold urine”) to 2 (“I am usually able to finish what I am doing before going to the toilet [without leaking]”).|Baseline and Week 12|Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12 (LOCF). The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.||scores on a scale||Standard Deviation|Mean
734235|NCT00425100|Secondary|Patient Perception of Bladder Condition (PPBC) Score at Week 12 Relative to Baseline (Categorical Change)|Improvement: negative score change; No change: score change=0; Deterioration: positive score change|Baseline and Week 12|Subjects in the Full Analysis Set (FAS) with non-missing change from baseline to Week 12 (LOCF). The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.||participants|||Number
734236|NCT00425100|Secondary|Patient Perception of Bladder Condition (PPBC) Score|The PPBC score ranges from 1 “no problems at all” to 6 “many severe problems.”|Baseline and Week 12|Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12 (LOCF). The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.||scores on a scale||Standard Deviation|Mean
734237|NCT00425100|Secondary|Mean Rating on the Urinary Sensation Scale|The mean rating was calculated as the sum of rating scores on the Urinary Sensation Scale divided by the total number of micturitions with non-missing rating at that visit. The scale ranges from 1 “no feeling of urgency” to 5 “unable to hold; leak urine.”|Baseline and Week 12|Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12 (LOCF). The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.||scores on a scale||Standard Deviation|Mean
734238|NCT00425100|Secondary|Severe Urgency Episodes Per 24 Hours|Severe urgency episodes defined as Urinary Sensation Scale (USS) rating ≥4. Subjects rated the feeling of urgency associated with each micturition episode using USS provided in the bladder diary. Scale ranges from 1=no feeling of urgency to 5=unable to hold; leak urine; decrease indicates an improvement with respect to urgency symptoms.|Baseline and Week 12|Subjects in the Full Analysis Set (FAS) with baseline severe urgency episodes >0 and non-missing numerical change from baseline to Week 12 (LOCF). The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.||number of episodes||Standard Deviation|Mean
734239|NCT00425100|Secondary|Nocturnal Micturitions Per 24 Hours|Nocturnal micturitions (synonymous with the term “nighttime micturitions”) were those recorded in the bedtime section of the bladder diary.|Baseline and Week 12|Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12 (LOCF). The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.||number of nocturnal micturitions||Standard Deviation|Mean
734240|NCT00425100|Primary|Number of Participants Reporting Satisfaction With Current Overactive Bladder (OAB) Treatment|Number of Participants who responded satisfied = (very satisfied or somewhat satisfied) and dissatisfied = (somewhat dissatisfied or very dissatisfied) to the treatment satisfaction question.|Week 12|Subjects in the Full Analysis Set (FAS) with non-missing value at Week 12. The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.||participants|||Number
734340|NCT00425945|Secondary|Body Mass Index|Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).|three months|||kg/m^2||Standard Deviation|Mean
734241|NCT00425100|Primary|Mean Number of Urgency Episodes Per 24 Hours|The mean number of urgency episodes per 24 hours is calculated as the total number of micturitions with Bladder Sensation Scale (BSS) >= 3 divided by the total number of diary days collected at that visit. BSS: 5 point scale measuring need to urinate from 1=no urgency to 5=unable to hold; leak urine.|Baseline and Week 12|Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12 (last observation carried forward (LOCF)).The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.||number of episodes||Standard Deviation|Mean
734242|NCT00425100|Primary|Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours|The mean number of UUI episodes per 24 hours is calculated as the total number of micturitions with Bladder Sensation Scale (BSS) = 5 divided by the total number of diary days collected at that visit. BSS: 5 point scale measuring need to urinate from 1=no urgency to 5=unable to hold; leak urine.|Baseline and Week 12|Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12 (last observation carried forward (LOCF)). The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment. Restricted to subjects with UUI at baseline >0.||number of episodes||Standard Deviation|Mean
734243|NCT00425100|Primary|Mean Number of Micturition Episodes Per 24 Hours|The mean number of micturitions per 24 hours is calculated as the total number of micturitions divided by the total number of diary days collected at that visit.|Baseline and Week 12|Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12 (last observation carried forward (LOCF)). The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.||number of episodes||Standard Deviation|Mean
734244|NCT00425113|Secondary|Time to Sputum Culture Conversion to Negative on Solid Medium||2 months|||days||95% Confidence Interval|Median
734245|NCT00425113|Primary|Changes in TB Lesion Sizes Using High Resolution Computed Tomography (HRCT).|Lesions were defined as nodules (<2 mm, 2-<4 mm, and 4-10 mm), consolidations, collapse, cavities, fibrosis, bronchial thickening, tree-in-bud opacities, and ground glass opacities. Each CT was divided into six zones (upper, middle, and lower zones of the right and left lungs) and independently scored for the above lesions by three separate radiologists blinded to treatment arm. A fourth radiologist adjudicated any scores that were widely discrepant among the initial three radiologists. The HRCT score was determined by visually estimating the extent of the above lesions in each lung zone as follows: 0=0% involvement; 1= 1-25% involvement; 2=26-50% involvement; 3=51-75% involvement; and 4=76-100% involvement. A composite score for each lesion was calculated by adding the score for each specific abnormality in the 6 lung zones and dividing by 6, with the change in composite score measured at 2 and 6 months compared to baseline. Composite sums of all 10 composite scores are reported.|6 months.|||reader score||Standard Error|Mean
734246|NCT00425269|Secondary|Intake of Fish, Post Test||post-test, after completion of all six group sessions|||portions/week||Inter-Quartile Range|Mean
734247|NCT00425269|Secondary|Intake of Poultry, Post-test||post-test, after completion of all six group sessions|||portions/week||Inter-Quartile Range|Mean
734248|NCT00425269|Secondary|Intake of Red Meat, Post-test||post-test, after completion of all six group sessions|||portions/week||Inter-Quartile Range|Mean
734249|NCT00425269|Secondary|Intake of Soft Drinks With Added Sugar, Post-test||post-test, after completion of all six group sessions|||dl/week||Inter-Quartile Range|Mean
734250|NCT00425269|Secondary|Intake of Vegetables, Fruit and Fruit Juice, Post-test||post-test, after completion of all six group sessions|||grams per day||Inter-Quartile Range|Mean
734251|NCT00425269|Secondary|Body Mass Index, Post-test||post-test, after completion of all six group sessions|||kg/m^2||95% Confidence Interval|Mean
734252|NCT00425269|Secondary|Waist Circumference||post-test, after completion of all six group sessions|||cm||95% Confidence Interval|Mean
734253|NCT00425269|Secondary|Diastolic Blood Pressure, Post-test||post-test, after completion of all six group sessions|||mmHg||95% Confidence Interval|Mean
734254|NCT00425269|Secondary|Systolic Blood Pressure, Post-test||post-test, after completion of all six group sessions|||mmHg||95% Confidence Interval|Mean
734255|NCT00425269|Secondary|Triglycerides, Post-test||post-test, after completion of all six group sessions|||mmol/L||95% Confidence Interval|Mean
734256|NCT00425269|Secondary|High-Density Lipoprotein Cholesterol, Post-test||post-test, after completion of all six group sessions|||mmol/L||95% Confidence Interval|Mean
734257|NCT00425269|Secondary|Insulin, 2-h, Post-test||post-test, after completion of all six group sessions|||pmol/L||95% Confidence Interval|Mean
734258|NCT00425269|Secondary|Insulin, 0-h, Post-test||post-test, after completion of all six group sessions|||pmol/L||95% Confidence Interval|Mean
734259|NCT00425269|Secondary|C-peptid, 2-h, Post-test||post-test, after completion of all six group sessions|||pmol/L||95% Confidence Interval|Mean
734260|NCT00425269|Secondary|C-peptid, 0-h, Post-test||post-test, after completion of all six group sessions|||pmol/L||95% Confidence Interval|Mean
734261|NCT00425269|Secondary|HbA1C, Post-test||post-test, after completion of all six group sessions|||percent of Hb||95% Confidence Interval|Mean
734262|NCT00425269|Primary|Plasma Glucose, 2-h, Post-test||post-test|||mmol/L||95% Confidence Interval|Mean
734263|NCT00425269|Primary|The Fasting Plasma Glucose, Post-test||post-test|||mmol/L||95% Confidence Interval|Mean
734264|NCT00425269|Secondary|Intake of Fish, Baseline||baseline|||portions/week||Inter-Quartile Range|Mean
734265|NCT00425269|Secondary|Intake of Poultry, Baseline||baseline|||portions/week||Inter-Quartile Range|Mean
734266|NCT00425269|Secondary|Intake of Red Meat, Baseline||baseline|||portions/week||Inter-Quartile Range|Mean
734267|NCT00425269|Secondary|Intake of Soft Drinks With Added Sugar, Baseline||baseline|||dL/week||Inter-Quartile Range|Mean
734268|NCT00425269|Secondary|Intake of Vegetables, Fruit and Fruit Juice, Baseline||baseline|||gram per day||Inter-Quartile Range|Mean
734269|NCT00425269|Secondary|Body Mass Index, Baseline||baseline|||kg/m^2||95% Confidence Interval|Mean
734270|NCT00425269|Secondary|Waist Circumference, Baseline||baseline|||cm||95% Confidence Interval|Mean
734271|NCT00425269|Secondary|Diastolic Blood Pressure, Baseline||baseline|||mmHg||95% Confidence Interval|Mean
734272|NCT00425269|Secondary|Systolic Blood Pressure, Baseline||baseline|||mmHg||95% Confidence Interval|Mean
734293|NCT00425308|Primary|Change in Glomerular Filtration Rate Estimated by Iohexol Plasma Clearance 12 Months After Randomization Between the 2 Groups of Patients.|Primary efficacy endpoint: between treatment analysis of change in iohexol plasmatic clearance (mL/min) from baseline to Month 12 (M12)|From Baseline to Month 12|Intent to Treat (ITT) Population: all patients with a baseline value||(mL/min)||Standard Error|Least Squares Mean
734294|NCT00425373|Secondary|Percentage of Patients Achieving MSDBP < 90 mm Hg and MSSBP < 140 mm Hg at the End of the Study (Week 8)|At study entry, blood pressure was measured in both arms using a standard method described in the protocol. The arm with the higher diastolic BP reading was used for the measurements at all subsequent visits. Blood pressure in the sitting position was measured after resting in a seated position for at least 5 minutes. The measurement was repeated a total of 3 times at intervals of 1 to 2 minutes. A negative number indicates lowered blood pressure.|Baseline to end of study (Week 8)|Intent-to-treat (ITT): All randomized patients who had a baseline and at least one post-baseline assessment of the variable analyzed. Baseline is the Week 0 value and end of study is the value at Week 8 or the last observation carried forward (LOCF) value.||Percentage of patients|||Number
734295|NCT00425373|Secondary|Percentage of Patients Achieving MSDBP < 90mmHg at the End of the Study (Week 8)|At study entry, blood pressure was measured in both arms using a standard method described in the protocol. The arm with the higher diastolic BP reading was used for the measurements at all subsequent visits. Blood pressure in the sitting position was measured after resting in a seated position for at least 5 minutes. The measurement was repeated a total of 3 times at intervals of 1 to 2 minutes. A negative number indicates lowered blood pressure.|Baseline to end of study (Week 8)|Intent-to-treat (ITT): All randomized patients who had a baseline and at least one post-baseline assessment of the variable analyzed. Baseline is the Week 0 value and end of study is the value at Week 8 or the last observation carried forward (LOCF) value.||Percentage of patients|||Number
734296|NCT00425373|Secondary|Percentage of Patients Achieving MSDBP < 90 mmHg or a => 10 mm Hg Decrease Compared to Baseline at the End of the Study (Week 8)|At study entry, blood pressure was measured in both arms using a standard method described in the protocol. The arm with the higher diastolic BP reading was used for the measurements at all subsequent visits. Blood pressure in the sitting position was measured after resting in a seated position for at least 5 minutes. The measurement was repeated a total of 3 times at intervals of 1 to 2 minutes. A negative number indicates lowered blood pressure.|Baseline to end of study (Week 8)|Intent-to-treat (ITT): All randomized patients who had a baseline and at least one post-baseline assessment of the variable analyzed. Baseline is the Week 0 value and end of study is the value at Week 8 or the last observation carried forward (LOCF) value.||Percentage of patients|||Number
734297|NCT00425373|Secondary|Change in Mean Sitting Systolic Blood Pressure (MSSBP) From Baseline to End of Study (Week 8)|At study entry, blood pressure was measured in both arms using a standard method described in the protocol. The arm with the higher diastolic BP reading was used for the measurements at all subsequent visits. Blood pressure in the sitting position was measured after resting in a seated position for at least 5 minutes. The measurement was repeated a total of 3 times at intervals of 1 to 2 minutes. A negative number indicates lowered blood pressure.|Baseline to end of study (Week 8)|Intent-to-treat (ITT): All randomized patients who had a baseline and at least one post-baseline assessment of the variable analyzed. Baseline is the Week 0 value and end of study is the value at Week 8 or the last observation carried forward (LOCF) value.||mm Hg||Standard Error|Least Squares Mean
734298|NCT00425373|Primary|Change in Mean Sitting Diastolic Blood Pressure (MSDBP) From Baseline to End of Study (Week 8)|At study entry, blood pressure was measured in both arms using a standard method described in the protocol. The arm with the higher diastolic BP reading was used for the measurements at all subsequent visits. Blood pressure in the sitting position was measured after resting in a seated position for at least 5 minutes. The measurement was repeated a total of 3 times at intervals of 1 to 2 minutes. A negative number indicates lowered blood pressure.|Baseline to end of study (Week 8)|Intent-to-treat (ITT): All randomized patients who had a baseline and at least one post-baseline assessment of the variable analyzed. Baseline is the Week 0 value and end of study is the value at Week 8 or the last observation carried forward (LOCF) value.||mm Hg||Standard Error|Least Squares Mean
734299|NCT00425386|Secondary|Maximum Percent Change in Tumor Measurement|The maximum percent change in Tumor Measurement is the greatest percent change in longest diameter (LD) for the target lesions from the baseline LD. For patients with no change in LD, the maximum percent change is the lowest increase in LD from the baseline LD.|Baseline through end of study, up to 7 years|||percent change in size||Full Range|Mean
734300|NCT00425386|Secondary|Proportion of Patients Whose Best Overall Response is Complete Response, Partial Response, Stable Disease, or Progressive Disease||From the start of treatment until the criteria for response is met.|||percentage of participants|||Number
734301|NCT00425386|Secondary|Median Time to Progression|The Kaplan-Meier method will be used to estimate the median time to progression.|For the duration of the study, up to 7 years|||months||95% Confidence Interval|Median
734302|NCT00425386|Secondary|To Determine the Safety of Sunitinib in Combination With Erlotinib||For the duration of the study, up to 7 years|||participants|||Number
734303|NCT00425386|Primary|Progression-free Survival at 8 Months|Defined as the proportion of patients who are progression free (CR, PR and SD) at 8 months after initiating treatment with sunitinib in combination with erlotinib in patients with metastatic or unresectable clear cell or papillary carcinoma of the kidney. Complete Response (CR)= disappearance of all target lesions, Partial Response (PR)= At least a 30% decrease in the sum of the longest diameter of target lesions, and Stable Disease (SD)= Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (20% increase in the sum).|8 months after initiating treatment with sunitinib in combination with erlotinib in patients with metastatic or unresectable clear cell or papillary carcinoma of the kidney|||percentage of participants||95% Confidence Interval|Number
734304|NCT00425386|Primary|Maximum Tolerated Dose (MTD) of Erlotinib Hydrochloride When Used in Combination With Sunitinib.|The MTD is defined as the dose that produces dose limiting toxicity (DLT) in 33% of the patients.|Participants assessed for DLTs weekly during the first cycle of treatment and every 3 weeks in subsequent cycles until at least one DLT occurs in 33% or more of participants at that dose; participants assessed for the duration of the study, up to 7 years|||milligrams|||Number
734305|NCT00425438|Primary|Complete Response (CR) by the End of Treatment - Percentage of Participants With an Event|CR was defined as a urinary protein value of less than (<) 500 mg per 24 hours (mg/24h) and no hematuria or cellular casts in the urine, and a stable serum creatinine value within the range of plus or minus (±) 25 percent (%) of baseline (BL) or some improvement.|Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48|Efficacy data were not analyzed because of study termination. The study was terminated early for administrative reasons and no participants completed all planned study visits; therefore efficacy analyses could not be performed.|||||
734306|NCT00425438|Secondary|Time to Treatment Failure|Treatment failure was defined as the occurrence of any of the following: death; chronic renal failure requiring dialysis or kidney transplantation; an increase in average serum creatinine values by 2-fold for 2 consecutive measures from BL, and a increase by 2-fold for 2 consecutive measures in at least 4 weeks; recurrent kidney disease defined by, proteinuria, a doubling in the ratio of urine protein to creatinine from BL and a urinary protein value of <0.5 g/24h or greater than (>) 1 g/24h or >0.5 g/24h or >2 g/24h at Week 24, kidney disease, defined by an increase in serum creatinine of 25% from BL along with a doubling of urinary protein of at least 2 g/24h, and hematuria, 2 or more blood cells per urine dipstick test.|Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48|Efficacy data were not analyzed because of study termination. The study was terminated early for administrative reasons and no participants completed all planned study visits; therefore efficacy analyses could not be performed.|||||
734307|NCT00425438|Secondary|Percentage of Participants Terminating Treatment||Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48|Efficacy data were not analyzed because of study termination. The study was terminated early for administrative reasons and no participants completed all planned study visits; therefore efficacy analyses could not be performed.|||||
734308|NCT00425438|Secondary|Percentage of Participants With a Decrease of 25% or 50% in Glomerular Filtration Rate (GFR)|GFR was calculated according to the simplified modification of diet in renal disease (MDRD) formula.|Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48|Efficacy data were not analyzed because of study termination. The study was terminated early for administrative reasons and no participants completed all planned study visits; therefore efficacy analyses could not be performed.|||||
734309|NCT00425438|Secondary|Percentage of Participants With Treatment Response Event by End of Treatment|Treatment response was defined by a reduction in the ratio of urine protein to creatinine to <3 mg/mg for participants with nephrotic proteinuria and a decrease of more than 50% in their urine protein to creatinine value from BL for participants with non-nephrotic proteinuria; a stable serum creatinine value or an increase of more than 30% from BL; and having not received IV prednisone after Week 28.|Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48|Efficacy data were not analyzed because of study termination. The study was terminated early for administrative reasons and no participants completed all planned study visits; therefore efficacy analyses could not be performed.|||||
734310|NCT00425438|Secondary|Complete Response|The median time, in months, to CR was defined as the time from randomization to CR event.|Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48|Efficacy data were not analyzed because of study termination. The study was terminated early for administrative reasons and no participants completed all planned study visits; therefore efficacy analyses could not be performed.|||||
734311|NCT00425503|Primary|The Purpose of the Present Study is to Assess the Safety of PS-341 as a Pretreatment in Patients Who Are to Undergo a Radical Prostatectomy. Poor Wound Healing and Excessive Bleeding, With Historical Rates of <1% and 10% Respectively Will be Measured.|Pour wound healing is defined in the protocol as dehiscence of fascia during the first postoperative week. Excessive bleeding is defined in the protocol as greater than 2 units of blood required during the first 24 hours after surgery.|Poor wound healing (dehiscence of fascia during the first postoperative week) and bleeding 24 hours after surgery|||Events|||Number
734312|NCT00425607|Primary|Proportion of Participants With Successful Rate of Weight Gain|"Activity was assessed by determining the change in rate of weight gain over two years from baseline (determined pre-therapy for each patient).
Primary outcome success was predefined as a 50% increase over pre-therapy in estimated annual rate of weight gain, or change from pre-therapy weight loss to statistically significant on-study weight gain."|Assessed at weeks 16, 32, 52, 68, 84 and 104|Results are reported for the 25 patients with classic HGPS who completed at least 2y of therapy. One additional patient with a prior history of strokes died of a stroke after 5 mo on study and is not included in the analysis. Two additional patients had nonclassic mutations and are not included in this analysis.||proportion of participants||95% Confidence Interval|Number
734313|NCT00425672|Secondary|Anti-tumor Effects of ONTAK Determined by Tumor Response and Progression|Anti-tumor effects of ONTAK will be determined by evaluating tumor response and progression per RECIST. An objective response to ONTAK will be defined as achieving a CR or PR. Analysis of the data will include determination of complete (CR) and partial response (PR) rates, as well as stable (SD) and progressive disease (PD).|21 days after cycle 6|||Participants|||Count of Participants
734314|NCT00425672|Secondary|Presence of Endogenous Tumor-specific Immunity|Evaluate the effect of ONTAK on endogenous tumor specific immunity|21 days after cycle 6|||Participants|||Count of Participants
734315|NCT00425672|Secondary|Presence of Circulating sIL-2R in the Peripheral Blood|Evaluate levels of circulating sIL-2R (pg/ml) in the peripheral blood assessed before and after ONTAK therapy. Changes from baseline will be tabulated.|21 days after cycle 6|4/14 patients had peripheral blood available before and after ONTAK treatment.||pg/ml||Full Range|Median
734316|NCT00425672|Secondary|Incidence of Interleukin-2 (IL-2) and IL-2 Receptor (IL-2R) Expression in Tumor Samples by Immunohistochemical (IHC) Analysis|The incidence of IL-2 expression and its receptor complex, IL-2R in tumor samples will be evaluated by IHC analysis. Tumor sections will be interpreted as either positive or negative.|21 days after cycle 6|||Participants|||Count of Participants
734317|NCT00425672|Primary|Efficacy of ONTAK in Depleting T-regulatory Cells as a Decrease in Peripheral Blood Tregs Using Flow Cytometry|The efficacy of ONTAK in depleting Tregs will be defined as a decrease in peripheral blood Tregs by 25% of each individual subject’s baseline. All subjects will undergo blood draws at baseline and post ONTAK infusions at designated time points. Tregs from the peripheral blood will be quantitated using flow cytometry.|21 days after cycle 6|14 patients equals patients that had repeat blood draws taken but did not complete the treatment except for 4 patients who completed the study||Participants|||Count of Participants
734318|NCT00425672|Primary|Safety Evaluated by Collecting Study Related Toxicity as Assessed by CTCAE v3.0|Subjects are monitored for the development of end organ damage by assessing adverse events with serum chemistries, liver function studies, serum albumin, complete blood counts, symptom assessment, and physical exams performed at every cycle until 3 weeks after the final dose of ONTAK. All adverse events for all systems are graded on a scale of 1-5 using CTCAE v3.0.|7 Days after last dose of ONTAK|||Participants|||Count of Participants
734319|NCT00425698|Secondary|Kidney Graft Function by Estimated Glomerular Filtration Rate (eGFR)|Estimated glomerular filtration rate (eGFR) was assessed using the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration)equation|6 month after transplantation||||||
734320|NCT00425698|Primary|Kidney Graft Function by Estimated Glomerular Filtration Rate (eGFR)|Estimated glomerular filtration rate (eGFR) was assessed using the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration)equation|42 days after transplantation|||ml/min||Standard Deviation|Mean
734321|NCT00425750|Secondary|Progression-free Survival|Median duration of survival without disease progression, calculated as on-study date to date of progression or date of death (censored) or off-study date (censored)|7.55 months (average duration, on study to off study)|||Month||95% Confidence Interval|Median
734322|NCT00425750|Secondary|Overall Survival|Median survival time of patients, calculated as on-study date to date of death or off-study date (censored)|7.55 months (average duration, on study to off study)|||Month||95% Confidence Interval|Median
734323|NCT00425750|Primary|Patient Response to Treatment|Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.|7.55 months (average duration, on study to off study)|||participants|||Number
734324|NCT00425854|Secondary|Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 29 (Cpre,ss,29)|Cpre,ss,29 represents the pre-dose concentration of afatinib in plasma at steady state on day 29.|day 29|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
734325|NCT00425854|Secondary|Best Change From Baseline in ECOG Performance Status|Best change from baseline in ECOG (Eastern Cooperative Oncology Group) performance status. ECOG is measured as score between 0 (fully active) and 5 (dead).|baseline till end of treatment|||participants|||Number
734326|NCT00425854|Secondary|Significant Change in Cardiac Left Ventricular Ejection Fraction (LVEF)|LVEF as measured by echocardiography or Multiple Gated Acquisition (MUGA) scan. MUGA scan is an useful noninvasive tool for assessing the function of the heart. Significant change in LVEF values was defined as >=20 percent decrease from baseline or to below lower limit of normal, which was defined as 50 percent.|Baseline and last assessment|TS||Participants|||Number
734327|NCT00425854|Secondary|Overall Survival (OS)|OS is defined as time from randomisation to death.|From randomisation to end of follow-up.|TS. As only 9 patient (31 percent) of Cohort A had died the median OS time was not estimable for Cohort A.||days||95% Confidence Interval|Median
734328|NCT00425854|Primary|Clinical Benefit (CB)|CB was defined as CR, PR or stable disease (SD) for a minimum of 4 months (modified CB) and was assessed according to RECIST 1.0 criteria. CB was primary endpoint only for Cohort A.|Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.|TS. No data for Cohort B as CB was primary endpoint only for Cohort A.||Participants|||Number
734329|NCT00425854|Primary|Objective Response (OR)|OR is defined as complete response (CR) and partial response (PR) and was assessed according to the Response Evaluation Criteria in Solid Tumours version 1.0 (RECIST). OR was primary endpoint only for Cohort B.|Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.|Treated Set (TS). TS consisted of all patients who received at least one dose of trial medication. No data for Cohort A as OR was primary endpoint only for Cohort B.||Participants with OR|||Number
734330|NCT00425854|Secondary|Progression-free Survival (PFS)|PFS was defined as the time from the first treatment to the occurrence of tumour progression or death, whichever came first. It was assessed according to RECIST 1.0 criteria as well as by the investigators assessment. Median time results from unstratified Kaplan-Meier estimates.|Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.|TS||days||95% Confidence Interval|Median
734331|NCT00425854|Secondary|Duration of OR|Duration of OR was measured from the time the criteria for CR or PR (whichever was documented first) were first met until the first date that progressive disease or death was objectively documented.|Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.|TS. Median duration of OR was not calcuable as there was no OR observed.|||||
734332|NCT00425854|Secondary|Time to OR|The time to OR was the duration from the first treatment to the time when the measurement criteria for CR and/or PR were met according to RECIST 1.0 criteria.|Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.|TS. Median time to OR was not calcuable as there was no OR observed.|||||
734333|NCT00425854|Secondary|Clinical Benefit (CB)|CB was defined as CR, PR or stable disease (SD) for a minimum of 4 months (modified CB) and was assessed according to RECIST 1.0 criteria. CB was secondary endpoint only for Cohort B as it was primary endpoint for Cohort A.|Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.|TS. No data for Cohort A as CB was secondary endpoint only for Cohort B.||Participants with CB|||Number
734334|NCT00425945|Secondary|AST/SGOT|Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).|three months|||u/L||Standard Deviation|Mean
734335|NCT00425945|Secondary|ALT/SGPT|Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).|three months|||u/L||Standard Deviation|Mean
734336|NCT00425945|Secondary|Hemoglobin A1c|Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).|three months|The data was analyzed on an intent-to-treat basis, with the last observation collected carried forward for participants with missing data at follow-up.||mg/dL||Standard Deviation|Mean
734337|NCT00425945|Secondary|Fasting Insulin|Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).|three months|||mg/dL||Standard Deviation|Mean
734338|NCT00425945|Secondary|Fasting Blood Glucose|Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).|three months|||mg/dL||Standard Deviation|Mean
734339|NCT00425945|Secondary|Weight|Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).|3 months|||lb||Standard Deviation|Mean
734341|NCT00425945|Secondary|C-reactive Protein|Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).|three months|The data was analyzed on an intent-to-treat basis, with the last observation collected carried forward for participants with missing data at follow-up.||nmol/L||Standard Deviation|Mean
734342|NCT00425945|Secondary|Lipoprotein A|Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up). Calculated as (Pinebark_Followup - Pinebark_Baseline) - (Placebo_Follow-up - Placebo_Baseline)|three months|||nmol/L||Standard Deviation|Mean
734343|NCT00425945|Secondary|HDL Particle Size|Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).|3 months|||nm||Standard Deviation|Mean
734344|NCT00425945|Secondary|LDL Particle Size|Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).|3 months|||nm||Standard Deviation|Mean
734345|NCT00425945|Secondary|Triglycerides|Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).|three months|||mg/dL||Standard Deviation|Mean
734346|NCT00425945|Secondary|HDL|Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).|3 months|||mg/dL||Standard Deviation|Mean
734347|NCT00425945|Secondary|LDL|Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).|3 months|||mg/dL||Standard Deviation|Mean
734348|NCT00425945|Secondary|Total Cholesterol|Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).|3 months|||mg/dL||Standard Deviation|Mean
734349|NCT00425945|Primary|Combined Change in Systolic and Diastolic Blood Pressures From Baseline to Week 12.|Mean at Week 12 observation minus mean at Baseline observation.|three months|The data was analyzed on an intent-to-treat basis, with the last observation collected carried forward for participants with missing data at follow-up.||mm Hg||95% Confidence Interval|Mean
734350|NCT00426127|Secondary|Safety and Effect of Chemo Regimen on D-Dimer Measured by Drawing D-Dimer Levels Every Cycle||3 weeks|There was no analysis done|||||
734351|NCT00426127|Secondary|Incidence of Elevated D-Dimer Measured by Drawing D-Dimer Levels Every Cycle|Incidence of elevated D-Dimer was defined as >.50 as drawn every cycle. Incidence of elevated D-Dimer was tested to determine safety and efficacy of the treatment regimen on patients with advanced pancreatic cancer.|3 weeks|2 patients received at least one cycle of treatment and underwent blood draws testing D-Dimer levels||Blood draw|||Number
734352|NCT00426127|Primary|Tumor Response Measured by CT Scans After Each Set of 3 Cycles of Chemotherapy||9 weeks|One participant underwent 3 cycles of therapy and progressed as assessed by CT.||Participants|||Count of Participants
734353|NCT00426153|Secondary|Change in Subject Reported Outcomes Using Mean Health Related Quality of Life (HRQoL) Scores|Scores on the Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36), version 2. Subjects completed the SF-36 which consists of 8 sub-scales which are additionally summarized into 2 summary components (physical and mental). The subscales and the summary scales both range from 0 to 100, with (0 = worst imaginable, 100 = best imaginable).|Baseline, 12 months|||units on a scale||Standard Deviation|Mean
734354|NCT00426153|Secondary|Percent Change in Glomerular Filtration Rate (GFR)|Percent change from baseline in renal function/GFR, measured by clearance of iothalamate with monitoring of bladder emptying using ultrasound|Baseline, 12 months|13 subjects were excluded from the analysis of the kidney data: 4 subjects had renal transplant before enrollment (3 in octreotide and 1 in placebo groups), 8 subjects had a diagnosis of ADPLD (4 in each group), 1 placebo subject has missing kidney data due to incomplete image coverage.||percent change||Standard Deviation|Mean
734355|NCT00426153|Secondary|Percent Change in Renal Volume|Percent change from baseline in renal volume, measured in milliliters by MRI or CT scans|Baseline, 12 months|13 subjects were excluded from the analysis of the kidney data: 4 subjects had renal transplant before enrollment (3 in octreotide and 1 in placebo groups), 8 subjects had a diagnosis of ADPLD (4 in each group), 1 placebo subject has missing kidney data due to incomplete image coverage.||percent change||Standard Deviation|Mean
734356|NCT00426153|Primary|Percent Change in Liver Volume|Percent change from baseline in liver volume, measured in milliliters by Magnetic Resonance Imaging (MRI)or Computed Tomography (CT) scans|Baseline, 12 months|||percent change||Standard Deviation|Mean
734357|NCT00426231|Secondary|Self-reported Medication Adherence|Only individuals with 6-month follow-up data were included in this analysis|6 months|||participants|||Number
734358|NCT00426231|Primary|Achievement of LDL-cholesterol Goals|Achieving the goal of an LDL cholesterol level of < 100 mg/dL. For intention to treat analysis the randomization visit status is carried forward if data are missing for the 6-month follow-up visit.|6 months|||participants|||Number
734359|NCT00426270|Secondary|Percentage of Participants With None, Minor, Mild, or Moderate Bleeding at Day 7|The investigator evaluated the severity of bleeding using the following rating scale: None (definitely no haemorrhage of any kind), Minor (few petechiae [≤ 100 total] and/or ≤ 5 small bruises [≤ 3 cm diameter], no mucosal bleeding), Mild (many petechiae [> 100 total] and/or > 5 large bruises [> 3 cm diameter], no mucosal bleeding), Moderate (overt mucosal bleeding [epistaxis, gum bleeding, oropharyngeal blood blisters, menorrhagia, gastrointestinal bleeding, etc] that does not require immediate medical attention or intervention).|Day 7|Full analysis set: All participants who received at least 1 dose of study medication, satisfied all major entry criteria, and had at least 1 post-baseline measurement of platelet count.||Percentage of participants|||Number
734360|NCT00426270|Secondary|Duration of the Clinical Response|The duration of the clinical response was the number of days that the platelet count remained ≥ 50*10^9/L. Platelet count was assessed on Days 2 through 7 and on Days 14, 21, and 63. A conservative method was used to calculate the duration of the clinical response. For example, if the platelet count was ≥ 50*10^9/L on Day 7 and dropped below 50*10^9/L at Day 14, Day 7 was used as the last day to calculate the duration of the clinical response. The same procedure was used if the platelet count dropped below 50*10^9/L at Day 21 from Day 14 or Day 63 from Day 21.|Day 2 to the end of the study (Day 63)|Full analysis set: All participants who received at least 1 dose of study medication, satisfied all major entry criteria, and had at least 1 post-baseline measurement of platelet count. Only participants with a clinical response were included in the analysis.||Days||Standard Deviation|Mean
734361|NCT00426270|Secondary|Maximum Platelet Count|Platelet count was assessed on Days 2 through 7 and on Days 14, 21, and 63. The maximum measured platelet count is reported.|Day 2 to the end of the study (Day 63)|Full analysis set: All participants who received at least 1 dose of study medication, satisfied all major entry criteria, and had at least 1 post-baseline measurement of platelet count.||*10^9/L||Standard Deviation|Mean
734362|NCT00426270|Secondary|Time to Achieve a Clinical Response|A clinical response is defined as an increase in platelet count to ≥ 50*10^9/L on any day from Day 2 to Day 7.|Day 2 to Day 7|Full analysis set: All participants who received at least 1 dose of study medication, satisfied all major entry criteria, and had at least 1 post-baseline measurement of platelet count. Only participants with a clinical response were included in the analysis.||Days||Standard Deviation|Mean
734363|NCT00426270|Primary|Percentage of Participants With a Clinical Response|A clinical response is defined as an increase in platelet count to ≥ 50*10^9/L on any day from Day 2 to Day 7.|Day 2 to Day 7|Full analysis set: All participants who received at least 1 dose of study medication, satisfied all major entry criteria, and had at least 1 post-baseline measurement of platelet count.||Percentage of participants|||Number
734364|NCT00426283|Secondary|To Investigate the Change in Subject Symptoms and Response to FP.||3 months||||||
734365|NCT00426283|Secondary|To Investigate Subject Compliance and Response to FP.||3 months||||||
734366|NCT00426283|Secondary|To Investigate the Relationship Between Gene Expression, Blood Levels (CBC, Serum IL-5, Eotaxin-3 and IgE) Eosinophil Phenotype, (Via Flow Cytometry and Functional Responses) and Response to FP.||3 months||||||
734367|NCT00426283|Secondary|To Investigate the Relationship Between Subject Age, Height, Weight, Allergic Status and Response to FP.||3 months||||||
734368|NCT00426283|Secondary|To Investigate the Safety of 1760mcg FP in the Treatment of EE Using Measurement of Serial Salivary Cortisol Levels and Adverse Reaction Data.||3 months||||||
734369|NCT00426283|Primary|The Percentage of Participants Who Attained Remission.|Remission is considered achieved when the highest eosinophil count per high power field (hpf) in all esophageal biopsies is </= 1 eosinophil/hpf after 3 months of therapy.|3 months|||percentage of participants||95% Confidence Interval|Number
734370|NCT00426361|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|Serious adverse events assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the active phase of the study (up to Month 7/8) and during the safety follow-up (up to Month 12/13)|Analysis was performed on the Total Vaccinated Cohort (for the active phase) and on the Extended Safety Follow-up Vaccinated Cohort (for the safety follow-up).||Subjects|||Number
734371|NCT00426361|Secondary|Number of Subjects Reporting Unsolicited Adverse Events as New Onset Chronic Diseases (NOCDs) and Other Medically Significant Adverse Events (MSAEs)|NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes. MSAEs assessed include AEs prompting emergency room or physician visits that are not related to common diseases or SAEs that are not related to common diseases.|During the active phase of the study (up to Month 7/8) and during the safety follow-up (up to Month 12/13)|Analysis was performed on the Total Vaccinated Cohort (for the active phase) and on the Extended Safety Follow-up Vaccinated Cohort (for the safety follow-up).||Subjects|||Number
734372|NCT00426361|Secondary|Number of Subjects Reporting Unsolicited Adverse Events|"Unsolicited adverse event = Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event."|During the 30-day period (Day 0-29) following vaccination|||Subjects|||Number
734373|NCT00426361|Secondary|Number of Subjects Reporting Solicited Symptoms|"Solicited local symptoms assessed include pain, redness and swelling at the injection site.
Solicited general symptoms assessed include arthralgia, fatigue, fever (above 37.5 degree Celsius), gastrointestinal symptoms, headache, myalgia, rash and urticaria."|During the 7-day period (Day 0-6) following each vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.||Subjects|||Number
734374|NCT00426361|Secondary|Number of Subjects With Booster Response to Pertussis Toxoid (PT), Pertactin Toxoid (PRN) and Filamentous Hemagglutinin (FHA)|"Booster response to PT, FHA and PRN were defined as:
For initially seronegative subjects [pre-vaccination titer below cut-off value of 5 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL)]: antibody titers at least 4 times the cut-off,
For initially seropositive subjects with pre-vaccination titer above 5 EL.U/mL and < 20 EL.U/mL: an increase in antibody titers of at least 4 times the pre-vaccination titer,
For initially seropositive subjects with pre-vaccination titer above 20 EL.U/mL: an increase in antibody titers of at least 2 times the pre-vaccination titer."|One month after vaccination with Boostrix Polio|Analysis was performed on the Month 1 According-to-Protocol (ATP) cohort for analysis of immunogenicity and only on those subjects vaccinated with Boostrix Polio.||Subjects|||Number
734375|NCT00426361|Secondary|Number of Subjects With Booster Response to Diphtheria and Tetanus|"Booster responses to diphtheria and tetanus were defined as:
For initially seronegative subjects (pre-vaccination titer below cut-off value of 0.1 International Units per Milliliter): antibody titers at least four times the cut-off (post-vaccination titer greater than or equal to 0.4 IU/mL), and
For initially seropositive subjects (pre-vaccination titer greater than or equal to 0.1 IU/mL): an increase in antibody titers of at least four times the pre-vaccination titer."|One month after vaccination with Boostrix Polio|Analysis was performed on the Month 1 According-to-Protocol (ATP) cohort for analysis of immunogenicity and only on those subjects vaccinated with Boostrix Polio.||Subjects|||Number
734376|NCT00426361|Secondary|Anti-poliovirus Type 1 (Anti-polio 1), Anti-polio 2 and Anti-polio 3 Antibody Titers|Titers are given as Geometric Mean Titers (GMTs). The titer is a serum dilution giving 50 percent reduction of signal compared to control without serum.|One month after vaccination with Boostrix Polio|Analysis was performed on the Month 1 According-to-Protocol (ATP) cohort for analysis of immunogenicity and only on those subjects vaccinated with Boostrix Polio.||titer||95% Confidence Interval|Geometric Mean
734377|NCT00426361|Secondary|Number of Subjects With Anti-diphtheria and Anti-tetanus Antibody Titers Above 1.0 International Units Per Milliliter (IU/mL)|Anti-diphtheria and anti-tetanus antibodies cut-off value assessed include 1.0 IU/mL.|One month after vaccination with Boostrix Polio|Analysis was performed on the Month 1 According-to-Protocol (ATP) cohort for analysis of immunogenicity and only on those subjects vaccinated with Boostrix Polio.||Subjects|||Number
734378|NCT00426361|Secondary|Titers of Anti-diphtheria and Anti-tetanus Antibodies|Titers are given as Geometric Mean Titers (GMTs) and expressed as IU/mL.|One month after vaccination with Boostrix-Polio|Analysis was performed on the Month 1 According-to-Protocol (ATP) cohort for analysis of immunogenicity and only on those subjects vaccinated with Boostrix Polio.||IU/mL||95% Confidence Interval|Geometric Mean
734379|NCT00426361|Secondary|Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies After Completing the Cervarix Vaccination Course|Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).|One month post Cervarix Dose 3 (Month 7/8)]|||EL.U/mL||95% Confidence Interval|Geometric Mean
734380|NCT00426361|Secondary|Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies After Incomplete Cervarix Vaccination Course|Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination. Cut-off values assessed include 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.|One month post Dose 1|Analysis was performed on the Month 1 According-to-Protocol (ATP) cohort for analysis of immunogenicity and only on subjects from the Cervarix and Cervarix + Boostrix Polio groups with available results for the defined antibody.||Subjects|||Number
734381|NCT00426361|Secondary|Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-HPV-18 Antibodies After Completing the Cervarix Vaccination Course|Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination. Cut-off values assessed include 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.|One month post Cervarix Dose 3 (Month 7/8)|Analysis was performed on the Month 7/8 According-to-Protocol (ATP) cohort for analysis of immunogenicity on subjects with available results for the defined antibody.||Subjects|||Number
734382|NCT00426361|Primary|Number of Subjects Seroprotected Against Poliovirus Type 1 (Polio 1), Polio 2 and Polio 3|Seroprotection against polio 1, 2 and 3 is defined as anti-polio 1, 2 and 3 antibody titers greater than or equal to 8 Effective Dose 50% (≥ 8 ED50).|One month after vaccination with Boostrix Polio|Analysis was performed on the Month 1 According-to-Protocol (ATP) cohort for analysis of immunogenicity and only on those subjects vaccinated with Boostrix Polio and with available results for the defined antigen.||Subjects|||Number
734383|NCT00426361|Primary|Titers of Anti-pertussis Toxoid (Anti-PT), Anti-pertactin Toxoid (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibodies|Titers are given as geometric mean titers (GMTs) calculated on all subjects and expressed as Enzyme-linked Immunosorbent Assay Units per Milliliter (EL.U/mL).|One month after vaccination with Boostrix Polio|Analysis was performed on the Month 1 According-to-Protocol (ATP) cohort for analysis of immunogenicity and only on those subjects vaccinated with Boostrix Polio.||EL.U/mL||95% Confidence Interval|Geometric Mean
734384|NCT00426361|Primary|Number of Subjects Seroprotected Against Diphtheria and Tetanus|Seroprotection against diphtheria and tetanus is defined as anti-diphtheria and anti-tetanus antibody titres greater than or equal to 0.1 International Units per Milliliter (≥ 0.1 IU/mL).|One month after vaccination with Boostrix Polio|Analysis was performed on the Month 1 According-to-Protocol (ATP) cohort for analysis of immunogenicity and only on those subjects vaccinated with Boostrix Polio.||Subjects|||Number
734385|NCT00417482|Secondary|Weight|For each subject, the change in weight in pounds between week 16 and randomization was calculated by subtraction, so that a positive value indicates an increase in weight over time.|Phase B, weeks 1-16 (study weeks 16-32)|Available data from all randomized subject (N=110) was used in this analysis. Weight measurements were unavailable at one or more time points for 3 subjects in the placebo group and for 6 subjects in the risperidone group.||pounds||Standard Deviation|Mean
734386|NCT00417482|Secondary|Physical Self-Maintenance Scale (PSMS)|Physical Self-Maintenance Scale, which ranges from 1 to 30, with higher scores indicating WORSE functioning. For each subject, the change in PSMS between week 16 and randomization was calculated by subtraction, so that a positive value indicates an increase in PSMS (worse functioning) over time.|Phase B, weeks 1-16 (study weeks 16-32)|All randomized subjects were included in this analysis, with the exception of one placebo subject for whom PSMS data was not available at one time point||units on a scale||Standard Deviation|Mean
734387|NCT00417482|Secondary|AIMS|The Abnormal Involuntary Movement Scale (AIMS) assesses signs of tardive dyskinesia, a movement disorder that can occur with prolonged use of antipsychotic medication. The AIMS score ranges from 0 to 35, with higher scores indicating more severe symptoms. For each subject, the change in AIMS score between week 16 and randomization was calculated by subtraction, so that a positive value indicates an increase in AIMS over time.|Phase B, weeks 1-16 (study weeks 16-32)|All randomized subjects were included in this analysis (N=110).||units on a scale||Standard Deviation|Mean
734388|NCT00417482|Secondary|Extrapyramidal Signs (EPS)|Extrapyramidal signs, also known as Parkinsonian signs, refer to signs of tremor, rigidity, and bradykinesia (slowed movement) that are seen in Parkinson's disease. Assessment of extrapyramidal signs (EPS) were made with the use of the Simpson-Angus scale (which ranges from 1-40) with higher scores indicating more extrapyramidal signs. For each subject, the change in EPS between week 16 and baseline (randomization) was calculated by subtraction, so that a positive value indicates an increase in EPS over time.|Phase B, weeks 1-16 (study weeks 16-32)|All randomized subjects were included in the analysis (N=110).||units on a scale||Standard Deviation|Mean
734389|NCT00417482|Secondary|Treatment Emergent Symptoms Scale (TESS)|The Treatment Emergent Symptom Scale (TESS) assesses 26 somatic symptoms. Total scores range from 0-26, with a score of 0 or 1 for each item. Higher scores indicate more somatic symptoms. For each subject, the change in TESS between week 16 and baseline (randomization) was calculated by subtraction, so that a positive value indicates an increase in TESS over time.|Phase B, weeks 1-16 (study weeks 16-32)|All randomized subjects were included in this analysis (N=110)||units on a scale||Standard Deviation|Mean
734390|NCT00417482|Secondary|Mini Mental State Exam (MMSE)|The MMSE assesses cognition. Scores range from 0-30, with higher scores indicating better cognition. For each subject, the change in MMSE between week 16 and baseline (randomization) was calculated by subtraction, so that a positive value indicates an increase in MMSE over time.|Phase B, weeks 1-16 (study weeks 16-32)|MMSE data were missing for 2 subjects in the placebo group and 1 subject in the risperidone group, so the number of subjects in this analysis were 38 (placebo) and 69 (risperidone), for a total of 107.||units on a scale||Standard Deviation|Mean
734391|NCT00417482|Secondary|Relapse by Study Week 48|Same definition and criteria as the primary outcome|16-32 weeks in Phase B (32-48 weeks in study)|Randomized subjects in each Arm who had not relapsed or terminated the study by the end of the first 16 weeks of Phase B were analyzed in the second 16 weeks of Phase B using intent to treat (ITT) principles.||participants|||Number
734392|NCT00417482|Primary|Relapse by Study Week 32|"A relapse occurred in Phase B (post-randomization) if both of the following criteria were met:
Increase in the Neuropsychiatric Inventory (NPI) core score of 30% or more OR a 5-point increase from the baseline NPI score at the end of Phase A
A score of 6 (much worse) or 7 (very much worse) on the Clinical Global Impression-Change (CGI-C) at any visit."|0-16 weeks in Phase B (16-32 weeks in study)|Analysis was performed as per intention to treat (ITT) principles.||participants|||Number
734393|NCT00417612|Primary|Reduction of Parathyroid Hormone Area Under the Curve (PTHauc) of 20% or Greater|Clinically significant reduction of Mean PTHauc (% decrease >/= 20) for Paricalcitol (Active Drug) and Placebo from Baseline to Month 12.|Measured at baseline and Month 12|||percentage of participants|||Number
734394|NCT00417612|Primary|Area Under the Curve for Parathyroid Hormone (PTH; Percentage Decrease)|Mean PTHauc (% decrease) for Paricalcitol (Active Drug) and Placebo from Baseline to Month 12.|Measured at baseline and Month 12|||participants|||Number
734395|NCT00417612|Secondary|Serum 1,25 (OH)2D||Measured at baseline and Month 12|||pg/ml||Standard Deviation|Mean
734396|NCT00417612|Secondary|Serum Intact Fibroblast Growth Factor 23 (FGF23)||Measured at baseline and Month 12|||pg/ml||95% Confidence Interval|Mean
734397|NCT00417612|Secondary|Percent Change in Urinary Calcium Excretion From Baseline to 1 Year|Percent change in daily urinary calcium excretion, which is calculated the measurements of the calcium in the subject's 24-hr urine collections done at baseline and at the 1 year timepoints|Measured at baseline and Month 12|||percent change||Standard Deviation|Mean
734398|NCT00417612|Secondary|Bone Scan Severity Score|"99-Tc-methylenediphosphonate bone scans were completed and analyzed using the following scale*: Bone scan severity scale with minimum score of 0 and maximum score of 4 (0 is no disease and 4 is greatest severity of disease).
Appearance of lumbar spine and the sacroiliac region were used as internal references to which all suspected lesions were compared, and scored as follows:
grade 0, normal scan without suspicious lesions grade 1, lesion(s) less intense than normal lumbar spine grade 2, lesion(s) similar in intensity to normal lumbar spine grade 3, lesions more intense than normal lumbar spine but similar to the normal sacroiliac region grade 4, lesions more intense than the normal sacroiliac region.
*devised by nuclear medicine radiologist at Yale New Haven Hospital"|Measured at baseline and Month 12|||units on a scale||Standard Deviation|Mean
734399|NCT00417612|Secondary|Serum Calcium||Measured at baseline and Month 12|||mg/dl||Standard Deviation|Mean
734400|NCT00417612|Secondary|Static Parameters of Serum Alkaline Phosphatase at Baseline and 1 Year for Paricalcitol and Placebo Arms.||Measured at baseline and Month 12|Alkaline phosphatase activity was analyzed separately for children (less than 18 years of age) and adults as values varied considerably between these two groups. In other outcome measure modules the paricalcitol group is comprised of 19 participants analyzed which includes adults and children. In this module, the children (2) are their own arm.||mg/dl||Standard Deviation|Mean
734401|NCT00417612|Primary|Area Under the Curve for Parathyroid Hormone (PTHauc) Measurement|Mean area under the curve for parathyroid hormone levels (PTHauc) sampled during a 26 hour study period, for Paricalcitol (Active Drug) and Placebo groups at Baseline and Month 12 .|Measured at baseline and Month 12|||nlEq*26hr/ml||Standard Deviation|Mean
734402|NCT00417885|Secondary|Clinical Benefit Rate (CBR)|The clinical benefit rate (CBR) was the measure for clinical benefit (CB) and was defined as the percent of subjects with confirmed CR or confirmed PR, or confirmed SD according to RECIST, relative to the total analysis population. CRs were those that persisted on repeat imaging study ?4 weeks after initial documentation of response.|From start of treatment until Day 1 of every other cycle (8 weeks)|ITT. Data were not analyzed due to early termination.||rate|||Number
734403|NCT00417885|Secondary|Time to Tumor Progression (TTP)|TTP was defined as the time from enrollment to first documentation of objective tumor progression. If tumor progression data included more than 1 date, the first date was used. TTP was to be calculated as (first event date - the date of enrollment +1)/7.|From start of treatment until Day 1 of every other cycle (8 weeks)|ITT. Data were not analyzed due to early termination.||weeks||Standard Deviation|Mean
734404|NCT00417885|Secondary|Overall Survival (OS)|OS was defined as the time from date of enrollment to date of death due to any cause. OS was to be calculated as (the event date - the date of enrollment +1)/7.|From start of study treatment until death|ITT. Data were not analyzed due to early termination.||weeks||Standard Deviation|Mean
734405|NCT00417885|Secondary|Duration of Response (DR)|DR was defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression or to death on study. If tumor progression data included more than 1 date, the first date was used. DR was to be calculated as (the end date for DR - first CR or PR that was subsequently confirmed +1)/7.|From start of treatment until Day 1 of every other cycle (8 weeks) or death due to cancer|Analyses on DR were to be performed for overall responders only. Data were not analyzed due to early termination.||weeks||Standard Deviation|Mean
734406|NCT00417885|Secondary|Overall Response (OR) According to the Response Evaluation Criteria in Solid Tumors (RECIST)|OR=from start of treatment until disease progression/recurrence. Complete response (CR)=disappearance of all target lesions. Partial response (PR)= ? 30% decrease in sum of longest dimensions of lesions taking as reference baseline sum longest dimensions. Progressive disease (PD)= ? 20% increase in sum of longest dimensions of lesions taking as reference smallest sum of the longest dimensions since treatment started, or appearance of ? 1 new lesion. Stable disease (SD)=neither shrinkage for PR or increase for PD taking as reference smallest sum of longest dimensions since treatment start.|From start of treatment until Day 1 of every other cycle (8 weeks)|Analyses on OR were performed for subjects who received at least 1 dose of study medication.||participants|||Number
734407|NCT00417885|Primary|Progression Free Survival (PFS)|PFS was defined as the time from enrollment to first documentation of objective tumor progression or to death on study due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. PFS was to be calculated as (first event date – the date of enrollment +1)/7.|From start of treatment until Day 1 of every other cycle (8 weeks) or death|Intent-To-Treat (ITT) = all subjects who were enrolled in the trial. Data were not analyzed due to early termination.||weeks||Standard Deviation|Mean
734408|NCT00417963|Secondary|Number of Participants Experiencing Restenosis|Number of participants experiencing Restenosis following placement of the ViVexx Carotid Stent.|12 months after implantation|Number of participants experiencing restenosis through 12 months from implantation.||number of participants|||Number
734409|NCT00417963|Secondary|Number of Participants Experiencing Lesion Success|number of participants experiencing achievement of <50% final residual diameter stenosis in the stented segment using the VIVEXX Carotid Stent and the Emboshield Embolic Protection System.|at time of implantation|number of participants with lesion success defined as <50% residual stenosis.||number of participants|||Number
734410|NCT00417963|Secondary|Number of Participants Experiencing Device Success|Number of participants with successful delivery and deployment of device with <50% residual stenosis.|at time of implantation|Number of participants with successful delivery and deployment of device with <50% residual stenosis.||number of participants|||Number
734411|NCT00417963|Secondary|Number of Participants Experiencing Stroke Related Neurologic Deficit|Number of participants experiencing stroke related neurologic deficit persisting at 30 days and attributed to the index procedure.|30 days from implantation|Number of participants experiencing stroke related neurologic deficit persisting at 30 days and attributed to index procedure.||number of participants|||Number
734412|NCT00417963|Secondary|Number of Patients Experiencing Access Site Complications|Access site complications requiring blood transfusion (> 1 unit) or open surgical repair.|30 days following implantation|Number of participants experiencing access site complications requiring blood transfusion (>1 unit) or open repair.||Number of participants|||Number
734413|NCT00417963|Secondary|Number of Participants Experiencing Target Lesion Revascularization(s) (TLR)|Number of participants experiencing a Target lesion revascularization(s) up to 12 months after implantation|12 months from implantation|Number of participants experiencing target lesion revascularization up to 12 months from implantation||Number of participants|||Number
734414|NCT00417963|Primary|Percentage of Patients Experiencing Major Adverse Events (MAE)|A composite of major adverse events (MAE) including any death, any stroke and/or myocardial infarction occurring during the first 30 days post-procedure and ipsilateral stroke between 31 and 365 days post procedure.|365 days from implantation|All patients who were enrolled in the pivotal cohort were analyzed as an intention to treat population.||percentage of participants||95% Confidence Interval|Mean
734415|NCT00417976|Secondary|Response Rates Defined by RECIST 1.0|The National Cancer Institutes Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 was used in accessing response for patients|6 months|||patients|||Number
734416|NCT00417976|Primary|Rate of Progression Free Survival at 6 Months (24 Weeks) From Initiation of Therapy||6 months|||percent of patients|||Number
734417|NCT00417989|Secondary|Quality of Life - Insulin Delivery System Rating Questionnaire (IDSRQ) for Subject Satisfaction With Type of Insulin Therapy|Difference of Baseline and 52 Weeks in Insulin Delivery System Rating Questionnaire (IDSRQ) for Subject Satisfaction with Type of Insulin Therapy, between the two study arms is presented. Both baseline and 52 weeks scores range from 0-100, with higher scores suggest higher satisfaction. Therefore, a positive number in the difference suggests higher satisfaction at 52 Weeks than Baseline.|Baseline and 52 Weeks|||participants||Standard Deviation|Mean
734418|NCT00417989|Secondary|Quality of Life - Short Form-36 (SF-36v2™), General Health|Difference of Baseline and 52 Weeks in Short Form-36 (SF-36v2™), General Health, between the two study arms (adult subjects only) is presented. Both baseline and 52 weeks scores range from 0-100, with higher scores suggest higher satisfaction. Therefore, a positive number in the difference suggests higher satisfaction at 52 Weeks than Baseline.|Baseline and 52 Weeks|Adult population (18 and older) only||Participants||Standard Deviation|Mean
734419|NCT00417989|Secondary|Health Economic Outcomes (MRU)||Baseline and 52 weeks||07/2017||||
734420|NCT00417989|Secondary|Quality of Life - Hypoglycemia Fear Scale (HFS), Overall Score|Difference of Baseline and 52 Weeks in Hypoglycemia Fear Scale (HFS) Overall Score between the two study arms (adult subjects only) is presented. Both baseline and 52 weeks scores range from 0-100, with lower scores suggest higher satisfaction. Therefore, a negative number in the difference suggests higher satisfaction at 52 Weeks than Baseline.|Baseline and 52 weeks|Adult population (18 and older) only||participants||Standard Deviation|Mean
734421|NCT00417989|Secondary|Changes From Baseline in Hyperglycemia Area Under the Curve (AUC) From Baseline to Week 52|Hyperglycemia is defined as a recorded blood glucose event > 180 mg/dL. The amount of time spent above this parameter will be analyzed and compared between groups from Baseline to Week 52.|Baseline and 52 weeks|||mmol/dl*min||Standard Deviation|Mean
734422|NCT00417989|Secondary|Changes in Hypoglycemia Area Under the Curve (AUC) From Baseline to Week 52;|Hypoglycemia is defined as a recorded blood glucose event <70mg/dL. The amount of time spent below this parameter will be analyzed and compared between groups from Baseline to Week 52.|Baseline and 52 weeks|||mmol/dl*min||Standard Deviation|Mean
734423|NCT00417989|Secondary|Overall Difference in Rate of Severe Hypoglycemia Events Between Study Arms From Baseline to Week 52|Severe Hypoglycemia is defined as a hypoglycemic episode absolutely requiring assistance from another person and preferably accompanied by a confirmatory BG by finger stick of less than 50 mg/dL (2.8 mmol/L). The rate evaluates the number of participants that experienced at least one severe hypoglycemia event and compares this number between the two study arms from Baseline to week 52. This measure identifies the rate or frequency of unique participant events.|Baseline and 52 weeks|||participants|||Number
734424|NCT00417989|Secondary|Difference in Frequency of Severe Hypoglycemia From Baseline to Week 52;|Severe Hypoglycemia is defined as a hypoglycemic episode absolutely requiring assistance from another person and preferably accompanied by a confirmatory Blood Glucose (BG) by finger stick of less than 50 mg/dL (2.8 mmol/L). The frequency evaluates the total number of events. This will be analyzed and compared between the two study arms from baseline to week 52.|Baseline and 52 weeks|||number of events|||Number
734425|NCT00417989|Primary|Change in A1c From Baseline to 52 Weeks|Change is defined as A1c at Week 52 minus A1c at Baseline in each study arm. The difference between the change in each group will then be analyzed. A1c measure is defined as the percent of glycated hemoglobin using one standardized assay for all subjects.|Baseline and 52 weeks|||Percent glycated hemoglobin||Standard Deviation|Mean
734426|NCT00418015|Primary|Visual Analog Pain Scale (0 to 100) at Analgesia Request Following Intrathecal Intervention|Visual analog pain scale (0 to 100) at 1st request for supplemental analgesia|VAS at analgesia request|Analysis population per protocol.||Units on a scale||Inter-Quartile Range|Median
734427|NCT00418015|Secondary|Subjects With Pruritus at 24 Hours Post Morphine|Subjects reporting pruritus in the first 24 hours post cesarean delivery|24 hours post cesarean delivery|||participants|||Number
734428|NCT00418015|Secondary|Severity of Pruritus Following Fentanyl|Severity of pruritus during labor analgesia|Labor analgesia|||participants|||Number
734429|NCT00418015|Primary|Duration of Intrathecal Analgesia Following Cesarean Delivery|Time until request for supplemental analgesia following intrathecal morphine/fentanyl for cesarean delivery|0 to 72 hours following cesarean delivery|Subjects that received fentanyl and morphine for postpartum analgesia after planned cesarean delivery were analyzed per protocol.||Hours||Inter-Quartile Range|Median
734430|NCT00418015|Primary|Duration of Intrathecal Fentanyl Analgesia|Time from intrathecal drug administration to request for analgesia either in laboring women of after cesarean delivery|Time (0-1440 minutes) to first analgesia request|Laboring parturients that received intrathecal fentanyl (25 micrograms) for initiation of labor analgesia were evaluated for this outcome per protocol.||Minutes||95% Confidence Interval|Median
734431|NCT00418093|Secondary|Determine the Nature and Degree of Toxicities Following Treatment With Oxaliplatin, Gemcitabine, and Bevacizumab in This Patient Population.|The nature and toxicities of treatment were graded per the National Cancer Institute Common Terminology Criteria of Adverse Events version 3.0 Patients with grade 2 or higher toxicity were reported|Toxicities were assessed every cycle and for up to 30 days after being removed from the trial|All patients enrolled||percentage of participants|||Number
734432|NCT00418093|Secondary|Overall Survival|Duration of time participants are alive after enrolling on the study. Assessed by clinical records|Assessed every 3 months until death from disease, other causes, or loss to follow up at a median follow up of 24 months|All patients enrolled||weeks||95% Confidence Interval|Median
734433|NCT00418093|Secondary|Progression Free Survival|Time participant remains free of progression of her disease. Evaluated by RECIST criteria|Assessed every 2 cycles (every 8 weeks) of chemotherapy until progression of disease is documented with a median duration of follow up of 24 months|19||weeks||95% Confidence Interval|Median
734434|NCT00418093|Primary|Partial Response Rate|Precentage of women who responded to the treatment regimen Response was determined by RECIST criteria|Outcome was assessed every 2 cycles (every 8 weeks) for the duration on study, an average of 4.5 cycles (18 weeks)|||percentage of patients on study|||Number
734435|NCT00418145|Secondary|Improvement Using Targeted Neurological Deficits (TND).||Day 28 and day 90|Data is also no longer accessible. Data was with biostatistician who no longer has data.|||||
734436|NCT00418145|Secondary|Frequency of Relapse Over Time (up to One Year) When Subjects With Relapsing Forms of MS Are Administered One Course of Oral Methylprednisolone Compared to IV Administration.||Day 28 and day 90 and day 365|Data is also no longer accessible. Data was with biostatistician who no longer has data.|||||
734437|NCT00418145|Secondary|Clinical Parameters of the Multiple Sclerosis Functional Composite Scale (MSFC) Between Oral and IV Steroid Therapy in Subjects With Relapsing Forms of MS.||Day 28 and day 90|Data is also no longer accessible. Data was with biostatistician who no longer has data.|||||
734438|NCT00418145|Primary|Expanded Disability Status Scale (EDSS) Mean Recovery From Day 0 to Day 28.|There is no data analysis for this study|Day 28 and Day 90|Data is also no longer accessible. Data was with biostatistician who no longer has data.|||||
734439|NCT00418184|Secondary|Lipid Profile (Cholesterol, HDL, Triglycerides)||on weeks 0,15||||||
734440|NCT00418184|Secondary|Biochemical Parameters in Blood - Liver Functions (SGPT, SGOT, Total Bilirubin), Kidney Functions (BUN, Creatinine), Na, K, Cl, Ca||on weeks 0,15||||||
734441|NCT00418184|Secondary|Complete Blood Counts||on weeks 0,15||||||
734442|NCT00418184|Secondary|Barkley Side Effects Rating Scale (SERS)||on weeks 0,15||||||
734443|NCT00418184|Secondary|Essential Fatty Acid (EFA)-Deficiency Symptoms||on weeks 0,15||||||
734444|NCT00418184|Secondary|Vital Signs||on weeks 0,15||||||
734445|NCT00418184|Secondary|Blood Monoamines Metabolism||on week 0, 15||||||
734446|NCT00418184|Secondary|Plasma and Red Blood Cells Fatty Acid Profile||on weeks 0,15||||||
734447|NCT00418184|Secondary|Child Health Questionnaire (CHQ)- Parent-completed Form 50||on weeks 0,15||||||
734448|NCT00418184|Secondary|Test of Variables of Attention (TOVA)||on weeks 0,15||||||
734449|NCT00418184|Secondary|Clinical Global Impression of Improvement||on weeks 0,15||||||
734450|NCT00418184|Secondary|Strength and Difficulties Questionnaires - Home Version||on weeks 0,15||||||
734451|NCT00418184|Secondary|Strength and Difficulties Questionnaires - School Version||on weeks 0,15||||||
734452|NCT00418184|Secondary|Conners Rating Scale - Home Version|A questionnaire that assesses symptoms of ADHD in children and adolescents according to the DSM-IV guidelines. It consists of questions on the childs home behavior. Based on the questionnaire results, subscales and global indexes are calculated, including restless-impulsive index, emotional lability index and hyperactive/impulsive subscale. The lowest scale score is 40 (best)and the highest is 90 (worse). Usually, a score below 62 is considered normal and a score above 62 is considered abnormal.|change from baseline in conners raiting scale at 15 weeks|The analysis includes per-protocol (PP) population. Out of the 162 children who completed the study, 15 children were excluded from PP analysis due to low compliance or protocol violation.||Scores on a scale||Standard Error|Mean
734453|NCT00418184|Primary|Conners Rating Scale - School Version|A questionnaire that assesses symptoms of ADHD in children and adolescents according to the DSM-IV guidelines. It consists of questions on classroom behavior. Based on the questionnaire results, subscales and global indexes are calculated, including restless-impulsive index, emotional lability index and hyperactive/impulsive subscale. The lowest scale score is 40 (best)and the highest is 90 (worse). Usually, a score below 62 is considered normal and a score above 62 is considered abnormal.|change from baseline in conners raiting scale at 15 weeks|The analysis includes per-protocol (PP) population. Out of the 162 children who completed the study, 15 children were excluded from PP analysis due to low compliance or protocol violation.||Scores on a scale||Standard Error|Mean
734454|NCT00418262|Secondary|Compare Growth While on Atomoxetine With Growth Before Entry Into Study.|Height measured in centimeters at the time of each visit as part of the vital signs.|12 months or study duration|Measurements of height were not consistently obtained on all subjects.||cm||Standard Deviation|Mean
734455|NCT00418262|Secondary|Determine if Changes in Behavior Seen With Short-term (Eight Weeks) Treatment of Children Are Maintained Over a Twelve Month Period.|Parent rate the frequency of 18 of their child's behaviors from not at all (0), just a little (1) , pretty much (2) to very much (3) for each behavior. The Item scores were summed to arrive at a total score which ranged from 0 to 54. The higher the score, the worse the behavior.|12 months or study duration|ADHD Parent Rating Scale||units on a scale||95% Confidence Interval|Mean
734456|NCT00418262|Primary|Pittsburg Side-Effects Scale: Trouble Sleeping|Trouble Sleeping Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation.|12 months or study duration|One subject participating in the RCT did not participate in the open label||units on a scale||Standard Deviation|Mean
734457|NCT00418262|Primary|Pittsburg Side-Effects Scale: Loss of Appetite|"Loss of Appetite
Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation"|12 months or study duration|One subject in the RCT did not enroll in the open label study||units on a scale||Standard Deviation|Mean
734458|NCT00418262|Primary|Pittsburg Side-Effects Scale: Hallucinations|"Hallucinations
Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation"|12 months or study duration|One subject in the RCT did not enroll in the open label study||units on a scale||Standard Deviation|Mean
734459|NCT00418262|Primary|Pittsburg Side-Effects Scale: Socially Withdrawn|"Socially Withdrawn
Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation"|12 months or study duration|One subject in the RCT did not enroll in the open label study||units on a scale||Standard Deviation|Mean
734460|NCT00418262|Primary|Pittsburg Side-Effects Scale: Tearful/Sad/Depressed|"Tearful/Sad/Depressed
Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation"|12 months or study duration|One subject in RCT did not participate in the open label study||units on a scale||Standard Deviation|Mean
734461|NCT00418262|Primary|Pittsburg Side-Effects Scale: Crabby/Irritable|"Crabby/Irritable
Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation"|12 months or study duration|One Subject in the RCT did not enroll in the open label study||units on a scale||Standard Deviation|Mean
734462|NCT00418262|Primary|Pittsburg Side-Effects Scale: Stomachaches|"Stomachaches
Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation"|12 months or study duration|One subject in the RCT did not enroll in the Open Label Study||units on a scale||Standard Deviation|Mean
734463|NCT00418262|Primary|Pittsburg Side-Effects Scale: Headaches|"Headaches
Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation"|12 months or study duration|One subject from the RCT did not enter the open label study||units on a scale||Standard Deviation|Mean
734464|NCT00418262|Primary|Pittsburg Side-Effects Scale: Dull/Tired/Listless|"Dull/Tired/Listless
Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation"|12 months or study duration|One subject from the RCT did not enter the open label study||units on a scale||Standard Deviation|Mean
734465|NCT00418262|Primary|Pittsburg Side-Effects Scale: Worried/Anxious|"Worried/Anxious
Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation"|12 months or study duration|One subject from RCT did not enroll in the open label study||units on a scale||Standard Deviation|Mean
734466|NCT00418262|Primary|Pittsburg Side-Effects Scale: Movements, Picking/Chewing Skin or Fingers|"Movements, Picking/Chewing Skin or Fingers
Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation"|12 months or study duration|27 IN PCT and one subject did not enroll in the safety efficacy study||units on a scale||Standard Deviation|Mean
734467|NCT00418262|Primary|Pittsburg Side-Effects Scale-Buccal, Lingual Movements|"Buccal, Lingual Movements
Parent rating of none (0), mild (1), moderate (2) or severe (3) for each manifestation."|12 months or study duration|Attrition||units on a scale||Standard Deviation|Mean
734468|NCT00418262|Primary|Pittsburg Side-Effects Scale: Motor Tics|"Motor Tics
Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation"|12 months or study duration|Children with FAS participating in the extend safety efficacy study||units on a scale||Standard Deviation|Mean
734469|NCT00418314|Secondary|All Cause, Cardiovascular and Heart Failure Hospitalization||12 months|||participants|||Number
734470|NCT00418314|Secondary|All-cause, Cardiovascular and Heart Failure Mortality;||12 months|Per protocol||participants|||Number
734471|NCT00418314|Primary|Heart Failure Clinical Composite Score|The clinical composite score classifies each randomized patient as improved, unchanged, or worse depending on the clinical response during and the clinical status at the end of the trial. Patients are considered improved if at the final visit they experienced a favorable change in NYHA functional class or in the patient global assessment (or both) but did not experience any major adverse clinical events during the course of the trial. Patients are considered worse if they experienced a major clinical event during the study duration or reported worsening of their NYHA class or global assessment at the final visit. Patients are considered unchanged if they are neither improved nor worse.|12 months|||participants|||Number
734472|NCT00418379|Primary|Average Adjusted Symptom Score (AAdSS)|"The Adjusted Symptom Score (AdSS) is a subject-specific symptom score which is adjusted for rescue medication use.
Participants assessed daily, during the Year 3 pollen period while on treatment, 6 rhinoconjunctivitis symptoms (sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes) each symptom is scored as follows: 0: no symptoms, 1: mild symptoms, 2: moderate symptoms, 3: severe symptoms. The sum of the 6 symptoms is the Rhinoconjunctivitis Total Symptom Score (RTSS) (range 0-18). If the subject took rescue medication on a given day, the AdSS equals the RTSS of that day or the AdSS of the day before, whichever is higher. This adjustment applies to the day of rescue medication use and the following day. Like the RTSS, the AdSS ranges from 0 to 18. The lower the score, the better the outcome."|Pollen period (average of 33.8 days) of Year 3|Full Analysis Set Year 3 (FASY3). FASY3 included all patients who received at least one dose of the investigational product and had at least one Adjusted Symptom Score (AdSS) during the pollen period while on treatment during the Year 3.||Units on a scale (range: 0 to 18)||Standard Error|Least Squares Mean
734473|NCT00418522|Other Pre-specified|Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 26 for the FAS|HbA1c lab value: Change = value at Week 26 minus value at Baseline.|Baseline, Week 26|FAS=all subjects who took at least 1 dose of study drug and had at least 1 post-baseline measurement. LOCF imputed missing data with any post-baseline visit. Using the FAS yielded supplemental analyses for the primary efficacy endpoint.||percent||Standard Deviation|Mean
734474|NCT00418522|Secondary|Change From Baseline in Diabetes Treatment Satisfaction Questionnaire-Status, Diabetes Treatment Satisfaction Questionnaire-Change, Diabetes-39, Mental Health Inventory-17, and SF-36 Vitality Domain Questionnaire|Due to cancellation of the EXUBERA program, the collected Patient Reported Outcome (PRO) data, including the Diabetes Treatment Satisfaction Questionnaire-Status, Diabetes Treatment Satisfaction Questionnaire-Change, Diabetes-39, Mental Health Inventory-17, and SF-36 vitality domain questionnaire were not summarized, and no statistical analyses were performed.|Baseline, Week 26||||||
734475|NCT00418522|Secondary|Change From Baseline in Body Mass Index (BMI) at Week 26|BMI value (kg/m2): Change = value at Week 26 minus value at Baseline.|Baseline, Week 26|FAS=all subjects who took at least 1 dose of study drug and had at least 1 post-baseline measurement. LOCF imputed missing data with any post-baseline visit. Number of subjects with BMI measurements at Baseline and Week 26: inhaled human insulin n=192, insulin glargine n=183.||kg/m2||Standard Deviation|Mean
734476|NCT00418522|Secondary|Change From Baseline in Body Weight at Week 26|Body weight value: Change = value at Week 26 minus value at Baseline.|Baseline, Week 26|FAS=all subjects who took at least 1 dose of study drug and had at least 1 post-baseline measurement. LOCF imputed missing data with any post-baseline visit. Number of subjects with body weight measurements at Baseline and Week 26: inhaled human insulin n=192, insulin glargine n=183.||kg||Standard Deviation|Mean
734477|NCT00418522|Secondary|Number of Nocturnal Hypoglycemic Events|A hypoglycemic event was identified by characteristic symptoms or blood glucose levels. Severe=the subject was unable to treat him/herself; had at least 1 neurological symptom; or blood glucose of < = 49 mg/dL. Events not meeting all 3 criteria were considered mild-moderate. Nocturnal hypoglycemia=event occuring from midnight to 5:59 am.|Months 1 to 7|Safety population=all subjects who took at least 1 dose of study drug.||events|||Number
734478|NCT00418522|Secondary|Crude Hypoglycemic Event Rate|crude event rate=(events)/(subject-months). Severe=the subject was unable to treat him/herself; had at least 1 neurological symptom; or blood glucose of < = 49 mg/dL. Events not meeting all 3 criteria were considered mild-moderate. Overall=mild, moderate, and severe.|Months 1 to 7|Safety population=all subjects who took at least 1 dose of study drug. Number of subjects with at least 1 hypoglycemic event during the course of the study that were evaluable at the specified month: n=inhaled human insulin, insulin glargine.||events / subject-months|||Number
734479|NCT00418522|Secondary|Number of Total Subject Months of Treatment|Number of total subject months of treatment. Subject months = number of days from start of treatment to the last day of active treatment + 1 day lag, including off-drug time)/30.44. Severe=the subject was unable to treat him/herself; had at least 1 neurological symptom; or blood glucose of < = 49 mg/dL. Events not meeting all 3 criteria were considered mild-moderate. Overall=mild, moderate, and severe.|Months 1 to 7|Safety population=all subjects who took at least 1 dose of study drug. Number of subjects with at least 1 hypoglycemic event during the course of the study that were evaluable at the specified month: n=inhaled human insulin, insulin glargine.||subject months|||Number
734480|NCT00418522|Secondary|Number of Total Hypoglycemic Events|A hypoglycemic event was identified by characteristic symptoms or blood glucose levels. Severe=the subject was unable to treat him/herself; had at least 1 neurological symptom; or blood glucose of < = 49 mg/dL. Events not meeting all 3 criteria were considered mild-moderate. Overall=mild, moderate, and severe. Total=events during the study.|Months 1 to 7|Safety population=all subjects who took at least 1 dose of study drug. Number of subjects with at least 1 hypoglycemic event during the course of the study that were evaluable at the specified month: n=inhaled human insulin, insulin glargine.||events|||Number
734481|NCT00418522|Secondary|Number of Subjects With Hypoglycemic Events|A hypoglycemic event was identified by characteristic symptoms or blood glucose levels. An event was severe if the subject was unable to treat him/herself; had at least 1 neurological symptom; or blood glucose of < = 49 mg/dL. Events not meeting all 3 criteria were considered mild-moderate. Overall=mild, moderate, and severe.|Months 1 to 7|Safety population=all subjects who took at least 1 dose of study drug. Number of subjects with at least 1 hypoglycemic event during the course of the study that were evaluable at the specified month: n=inhaled human insulin, insulin glargine.||participants|||Number
734482|NCT00418522|Secondary|Change From Baseline in Mean Standard Deviation (SD) of 24-Hour Glucose Values Measured by CGMS at Week 26|SD of 24-Hour CGMS glucose lab value obtained using the Medtronic MiniMed CGMS. Not all subjects were offered the opportunity to participate in this assessment. Change = value at Week 26 minus value at Baseline.|Baseline, Week 26|FAS-CGMS=all subjects with at least 1 study drug dose, at least 1 post-baseline measurement, and who participated in a 24-hour CGMS substudy. LOCF imputed missing data with any post-baseline visit. Number of subjects who participated in the substudy with 24-hour CGMS values at Baseline and Week 26: inhaled human insulin n=2, insulin glargine n=8.||mg/dL||Standard Deviation|Mean
734483|NCT00418522|Secondary|Change From Baseline in 24-Hour Continuous Glucose Monitoring System (CGMS) Glucose Values at Week 26|24-Hour CGMS glucose lab value was obtained using the Medtronic MiniMed CGMS. Not all subjects were offered the opportunity to participate in this assessment. Change = value at Week 26 minus value at Baseline.|Baseline, Week 26|FAS-CGMS=all subjects with at least 1 study drug dose, at least 1 post-baseline measurement, and who participated in a 24-hour CGMS substudy. LOCF imputed missing data with any post-baseline visit. Number of subjects who participated in the substudy with 24-hour CGMS values at Baseline and Week 26: inhaled human insulin n=2, insulin glargine n=8.||mg/dL||Standard Deviation|Mean
734484|NCT00418522|Secondary|Change From Baseline in CV Biomarkers Adiponectin and Apolipoprotein B (ApoB) at Week 26|CV biomarker (adiponectin and ApoB) lab value: Change = value at Week 26 minus value at Baseline.|Baseline, Week 26|FAS=all subjects who took at least 1 dose of study drug and had at least 1 post-baseline measurement. LOCF imputed missing data with any post-baseline visit. Number of subjects with CV biomarker data (adiponectin and ApoB) at Baseline and Week 26: n=inhaled human insulin, insulin glargine.||mg/mL||Standard Deviation|Mean
734485|NCT00418522|Secondary|Change From Baseline in Cardiovascular (CV) Biomarkers High Sensitivity C-reactive Protein (Hs-CRP), Leptin, and Spot Urine Microalbumin at Week 26|CV biomarker (hs-CRP, Leptin, and Spot Urine Microalbumin) lab value: Change = value at Week 26 minus value at Baseline.|Baseline, Week 26|FAS=all subjects who took at least 1 dose of study drug and had at least 1 post-baseline measurement. LOCF imputed missing data with any post-baseline visit. Number of subjects with CV biomarker data (hs-CRP, leptin, and spot urine microalbumin) at Baseline and Week 26: n=inhaled human insulin, insulin glargine.||mg/L||Standard Deviation|Mean
734486|NCT00418522|Secondary|Change From Baseline in Lipids at Week 26|Lipid (total cholesterol, high density lipoprotein cholesterol [HDL-c], low density lipoprotein cholesterol [LDL-c], triglycerides) lab value: Change = value at Week 26 minus value at Baseline.|Baseline, Week 26|FAS=all subjects who took at least 1 dose of study drug and had at least 1 post-baseline measurement. LOCF imputed missing data with any post-baseline visit. Number of subjects with lipids data at Baseline and Week 26: n=inhaled human insulin, insulin glargine.||mg/dL||Standard Deviation|Mean
734487|NCT00418522|Secondary|Change From Baseline in Postprandial Blood Glucose as Measured by 8-Point Profiles at Week 26|Post-prandial=after a meal. 8-point scale: (1 = before breakfast, 2 = 2 hours post breakfast, 3 = before lunch, 4 = 2 hours post lunch, 5 = before dinner, 6 = 2 hours post dinner, 7 = at bedtime, 8 = overnight [between 2 and 4 am]). Postprandial blood glucose lab value: Change = value at Week 26 minus value at Baseline.|Baseline, Week 26|FAS = all subjects who took at least 1 dose of study drug and had at least 1 post-baseline measurement. LOCF imputed missing data with any post-baseline visit. Number of subjects with postprandial blood glucose measurements as measured by 8-point profiles at Baseline and Week 26: n=inhaled human insulin, insulin glargine.||mg/dL||Standard Deviation|Mean
734488|NCT00418522|Secondary|Change From Baseline in Fasting and Postprandial Blood Glucose as Determined by Standardized Meal Tolerance Tests at Week 26|Postprandial blood glucose lab value (Time 0 min [fasting], Time 30 min, Time 60 min, Time 90 min, Time 120 min, Time 180 min): Change = value at Week 26 minus value at Baseline.|Baseline, Week 26|FAS=all subjects who took at least 1 dose of study drug and had at least 1 post-baseline measurement. LOCF imputed missing data with any post-baseline visit. Number of subjects with fasting and postprandial blood glucose measurements determined by standardized meal tolerance tests at Baseline and Week 26: n=inhaled human insulin, insulin glargine.||mg/dL||Standard Deviation|Mean
734489|NCT00418522|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 26|Fasting plasma glucose lab value: Change = value at Week 26 minus value at Baseline.|Baseline, Week 26|FAS=all subjects who took at least 1 dose of study drug and had at least 1 post-baseline measurement. LOCF imputed missing data with any post-baseline visit. Number of subjects with fasting plasma glucose at Baseline and Week 26: inhaled human insulin n=202, insulin glargine n=189.||mg/dL||Standard Deviation|Mean
734490|NCT00418522|Secondary|Percentage of Subjects Achieving Glycemic Control (HbA1c < 8.0%) at Week 26|Number of subjects with glycosylated hemoglobin A1c lab value less than 8.0%.|Week 26|FAS=all subjects who took at least 1 dose of study drug and had at least 1 post-baseline measurement. LOCF imputed missing data with any post-baseline visit. Number of subjects with HbA1c < 8.0% at Week 26: inhaled human insulin n=162, insulin glargine n=158.||percentage of participants|||Number
734491|NCT00418522|Secondary|Percentage of Subjects Achieving Glycemic Control (HbA1c < 7.0%) at Week 26|Percentage of subjects with glycosylated hemoglobin A1c lab value less than 7.0%.|Week 26|FAS=all subjects who took at least 1 dose of study drug and had at least 1 post-baseline measurement. LOCF imputed missing data with any post-baseline visit. Number of subjects with HbA1c < 7.0% at Week 26: inhaled human insulin n=127, insulin glargine n=90.||percentage of participants|||Number
734492|NCT00418522|Secondary|Percentage of Subjects Achieving Glycemic Control (HbA1c < 6.5%) at Week 26|Percentage of subjects with glycosylated hemoglobin A1c lab value less than 6.5%.|Week 26|FAS=all subjects who took at least 1 dose of study drug and had at least 1 post-baseline measurement. LOCF imputed missing data with any post-baseline visit. Number of subjects with HbA1c < 6.5% at Week 26: inhaled human insulin n=72, insulin glargine n=42.||percentage of participants|||Number
734493|NCT00418522|Primary|Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 26 for the Per Protocol (PP) Population|HbA1c lab value: Change = value at Week 26 minus value at Baseline.|Baseline, Week 26|Per protocol (PP)=Full Analysis Set (FAS) subjects (i.e., had >=1 study drug dose and >=1 post-baseline measurement) with >=12 weeks treatment and no major protocol violation. LOCF imputed missing data with any post-baseline visit. Number of subjects with HbA1c values at Baseline and Week 26: inhaled human insulin n=154, insulin glargine n=157.||percent||Standard Deviation|Mean
734494|NCT00418561|Other Pre-specified|Physical Examination Results|Physical examination included general appearance, skin, head, ears, eyes, nose and throat, lymph nodes, heart, lungs, abdomen, extremities/joints, hip, neurological, mental status and, if appropriate, breasts, external genitalia, pelvic and rectal, and in addition weight, height and head circumference were recorded.|Baseline up to Week 26|Physical examination results were not summarized since data were collected in participant’s listing only as planned.|||||
734495|NCT00418561|Primary|Arylsulfatase A (ASA) Activity in Leukocytes||Pre-dose and post-dose at 24 hours on Day 0 and at Weeks 8 and 26|Data were not available to report as ASA activity in leukocytes was presented graphically, as per planned analysis.|||||
734496|NCT00418561|Primary|Maximum Plasma Drug Concentration (Cmax) of Recombinant Human Arylsulphatase A (rhASA)||Pre-dose and post-dose at 20, 40, 90 minutes, 3, 6 and 8 hours on Day 0, 40 minutes post-dose at Week 4, Pre-dose and post-dose at 20, 40, 90 minutes, 3, 6 and 8 hours at Week 8|Due to quick disappearance of rhASA from plasma, rhASA levels were not possible to report.|||||
734497|NCT00418561|Other Pre-specified|Change From Baseline in Amplitude at Week 26|Abbreviations: MN=Median Nerve; PN=Peroneal Nerve; SN=Sural Nerve; Dig.=Digit; APB=abductor pollicis brevis; EDB=extensor digitorum brevis.|Baseline, Week 26|"ITT. Here, N signifies the number of participants who were evaluable for the respective category."||millivolts||Standard Deviation|Mean
734498|NCT00418561|Other Pre-specified|Change From Baseline in Neurofilament Proteins (NFP), Glial Fibrillary Acidic Protein (GFAP) and Tauprotein in Cerebrospinal Fluid (CSF) at Week 26||Baseline, Week 26|"ITT. Here, N signifies the number of participants who were evaluable for the respective category."||nanogram/milliliter||Standard Deviation|Mean
734499|NCT00418561|Other Pre-specified|Change From Baseline in Chitotriosidase at Week 26||Baseline, Week 26|"ITT. Here, N signifies the number of participants who were evaluable for the respective category."||nanomole/hour/milliliter||Standard Deviation|Mean
734500|NCT00418561|Other Pre-specified|Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Findings|Abnormal ECG findings were considered as clinically significant at the discretion of investigator.|Baseline up to Week 26|ITT||participants|||Number
734501|NCT00418561|Other Pre-specified|Number of Participants With Abnormal Findings in Urine Analysis|The parameters analyzed in urine were albumin/protein, glucose, leucocytes, acetoacetate/ketones, nitrite and pH. Urine analysis findings were considered abnormal as judged by the investigator.|Baseline up to Week 26|ITT||participants|||Number
734502|NCT00418561|Other Pre-specified|Number of Participants With Shift From Baseline to Week 26 in Clinical Laboratory Evaluations: Hematology|"Number of participants with at least 1 shift from baseline to Week 26 are reported.
Abbreviations: Abs=Absolute count; ERCS=Erythrocytes; MCHC=Mean corpuscular hemoglobin concentration; MCH=Mean cell hemoglobin."|Baseline up to Week 26|"ITT. The number of participants analyzed in the Cohort 2 are the participants evaluable for this outcome. Here, N signifies the number of participants who were evaluable for the respective category."||participants|||Number
734503|NCT00418561|Other Pre-specified|Number of Participants With Shift From Baseline to Week 26 in Clinical Laboratory Evaluations: Genotyping|"Number of participants with at least 1 shift from baseline to Week 26 are reported.
Abbreviations: CSF=Cerebrospinal fluid; NFP=Neurofilament proteins."|Baseline up to Week 26|"ITT. The number of participants analyzed in the Cohort 2 are the participants evaluable for this outcome. Here, N signifies the number of participants who were evaluable for the respective category."||participants|||Number
734504|NCT00418561|Other Pre-specified|Number of Participants With Shift From Baseline to Week 26 in Clinical Laboratory Evaluations: Coagulation|Number of participants with at least 1 shift from baseline to Week 26 are reported. The shift reported below for Cohort 1 was from low level at baseline to low level at Week 26.|Baseline up to Week 26|ITT. Data for Cohorts 2 and 3 were not reported since there were no participants with shift from baseline to Week 26 in coagulation evaluations.||participants|||Number
734505|NCT00418561|Other Pre-specified|Number of Participants With Shift From Baseline to Week 26 in Clinical Laboratory Evaluations: Biochemistry|"Number of participants with at least 1 shift from baseline to Week 26, are reported.
Abbreviations: ALT=Alanine transaminase; CK=Creatine kinase; AP=Amyloid P component; LDH=Lactate dehydrogenase."|Baseline up to Week 26|ITT. Here, number of participants analyzed in the Cohort 2 are the participants evaluable for this outcome.||participants|||Number
734506|NCT00418561|Secondary|Change From Baseline in Paediatric Evaluation of Disability Inventory (PEDI) Scores at Week 26|PEDI is used for the clinical evaluation of functional capabilities, performance and changes in functional skills in children with disabilities. It consisted of 20 items scored on a scale from 0 (total assistance) to 5 (independent). Total score ranged from 0-100 with higher scores indicating better functioning. None, child, rehab, extensive are items in 3 domains (self-care, mobility and social functioning).|Baseline, Week 26|"ITT. Here, N signifies the number of participants who were evaluable for the respective category."||units on a scale||Standard Deviation|Mean
734507|NCT00418561|Secondary|Number of Participants With Shift From Baseline to Week 26 in Magnetic Resonance Imaging (MRI)-Loes Scores|Loes scoring system is used to grade the demyelinating abnormalities on brain MRI. A total of 17 locations of the brain were scored from 0 (normal appearance) to 2 (dense appearance). The total score ranged from 0 to 34 with a score of 14 or greater being considered severe. Number of participants with any shift of score between 0 to 2 for each of the 17 locations (Parieto Occipital [PO]-Periventricular [P], Central [C], Subcortical [Sc]; Anterior Temporal [AT]-P, C, Sc; Frontal [F]-P, C, Sc; Corpus Callosum [CC]-Splenium [S], Genus [G]; Projection Fibers [PF]-Capsular interna [CI] ant, CI post, Brainstem [B]; Cerebellum [Cb]-Cortex, Atrophy; Basal Ganglia [BG]-BG, Thalamus [T]; Cerebral Atrophy [CA]-CA), are only reported.|Baseline up to Week 26|ITT. Here, number of participants analyzed in the Cohort 2 are the participants evaluable for this outcome.||participants|||Number
734508|NCT00418561|Secondary|Number of Participants Who Had Undergone Nerve Biopsy and Had a Normal Nerve at Both Baseline and Week 26||Baseline, Week 26|ITT.||participants|||Number
734509|NCT00418561|Secondary|Change From Baseline in Nerve Conduction Velocity at Week 26|"An electrophysiological evaluation using standard electrophysiological and electromyography to measure the speed and extent of nerve conduction and units are expressed in meters per second.
Abbreviations: MN=Median Nerve; PN=Peroneal Nerve; SN=Sural Nerve; Dig.=Digit; FH=fibular hemimelia; L LM=left lateral medial; R LM=right lateral medial; MC=medial collateral."|Baseline, Week 26|"ITT. Here, N signifies the number of participants who were evaluable for the respective category."||meters per second||Standard Deviation|Mean
734510|NCT00418561|Primary|Change From Baseline in Mullen’s Scales of Early Learning at Week 26|Mullen's Scales of Early Learning is used to assess performance and learning ability in young children. The scale consisted of 144 items that had specific scoring criteria for each item. The scores were converted to T-scores with a decrease in score indicating worsening of disease. Relative change from baseline at Week 26 was calculated as percentage change from baseline divided by the age-difference in months between first and last visit. Adjusted mean and 95 percent (%) confidence intervals were reported.|Baseline, Week 26|ITT||percent (%) change||95% Confidence Interval|Mean
734511|NCT00418561|Primary|Number of Participants With Shift From Baseline to Week 26 in Sulfatide Levels in Urine|Number of participants with shifts between negative (value=0) and positive (value=1) values in urine sulfatide levels from baseline at Week 26 is reported.|Baseline up to Week 26|ITT. Here, the number of participants analyzed are the participants evaluable for this outcome.||participants|||Number
734512|NCT00418561|Primary|Change From Baseline in Cerebrospinal Fluid (CSF) Sulfatide at Week 26|Relative change from baseline at Week 26 was calculated as percentage change from baseline divided by the age-difference in months between first and last visit. Adjusted mean and 95 percent (%) confidence intervals were reported.|Baseline, Week 26|ITT||percent (%) change||95% Confidence Interval|Mean
734513|NCT00418561|Primary|Change From Baseline in Gross Motor Function Measure (GMFM) at Week 26|GMFM was measured using GMFM-88 item scores and summed to calculate a total GMFM-88 score. For each GMFM-88 item, the score was between 0 (minimal) to 3 (maximum). The total GMFM-88 score was between 0 (minimal) and 264 (maximum). The decrease in GMFM score over time indicates worsening of disease over time. Relative change from baseline at Week 26 was calculated as percentage change from baseline divided by the age-difference in months between first and last visit. Adjusted mean and 95 percent (%) confidence intervals were reported.|Baseline, Week 26|ITT||percent (%) change||95% Confidence Interval|Mean
734514|NCT00418561|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs)|An adverse event (AE) is any untoward, undesired, unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiological observations occurring in a participant, participating in a clinical study with study drug, regardless of causal relationship. TEAEs were AEs occurred after study drug administration that were absent before treatment or that worsened relative to pre-treatment state, up to Week 28 until evaluation (when last cohort had 26-week evaluation and data management performed within 4 weeks) completed.|From study drug administration up to Week 28|Intent-to-treat (ITT) population included all participants who received at least 1 dose of study drug.||participants|||Number
734527|NCT00418834|Other Pre-specified|Percent Change From Baseline in Ratio of Highly Selective C-Reactive Protein (Hs-CRP) at Week 12||Baseline and Week 12|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
734515|NCT00418574|Secondary|Time Course of Immunoresponse|Time course of immunologic parameters (anti-anti-idiotypic antibody - Ab3) will be assessed in all patients, by comparing levels at baseline (week 0), at week 10 after first dose administration and at end of treatment (at week 4 or week 12 after the last administered dose, as appropriate).|at baseline, at week 10 after first dose administration and at final study visit (at week 4 or week 12 after the last administered dose, as appropriate)|Participants who received abagovomab (evaluable population)and have baseline serum sample: 576 at baseline; 538 at week 10 after first dose intake; 449 at the final study visit||ng/ml||Full Range|Median
734516|NCT00418574|Secondary|Safety|"Safety was analyzed in all patients who received at least 1 dose administration.
Adverse event (AE) are defined as events which started on or after the first dose of study medication and on or before the date of the final study visit, or within 12 weeks of the last dose if the final study visit was not performed."|Along treatment administration and up to double blind observation period. i.e. for each patient after the first dose administration till the f inal study visit, or within 12 weeks of the last dose|Safety population (i.e. All randomized patients who received at least one dose treatment administration)||participants|||Number
734517|NCT00418574|Secondary|Overall Survival|2 years survival rate|2 years|intention to treat (ITT) population (i.e. all randomized patients)||Percentage of participants|||Number
734518|NCT00418574|Primary|Recurrence Free Survival Evaluated by Clinical Event Adjudication Committee (CEAC)|The Recurrence free survival correspond to the time from date of randomization to documented disease recurrence or death. Disease recurrence is defined as the appearance of any lesion or development of tumor-related symptoms evaluated by medical examination and must be confirmed by a documented CT scan.|Every 12 weeks up to recurrence or up to 3 months after last administered dose|intention to treat (ITT) population (i.e. all randomized patients)||days||95% Confidence Interval|Median
734519|NCT00418665|Secondary|Platelet Transfusion|Occurrence of one or more platelet transfusions during the treatment period|Treatment period (up to 16 weeks)|Full Analysis Set, composed of all randomized participants||Participants|||Number
734520|NCT00418665|Secondary|Achieving an Overall Response (Complete Response (CR) or Partial Response (PR)) Determined by the Investigator Based on Modified International Working Group 2006 Response Criteria Guidelines|CR = decrease in bone marrow blast (≤5%) and improvement in peripheral blood counts (Hgb ≥ 11 g/dL, platelets ≥ 100x10^9/L, neutrophils ≥ 1x10^9/L, peripheral blasts=0%). PR = improvement in peripheral blood counts plus a decrease in bone marrow blasts ≥50% but not ≤5, or decrease in International Prognostic Scoring System score.|Treatment period and post-treatment follow-up (up to 21 weeks)|Full Analysis Set, composed of all randomized participants||Participants|||Number
734521|NCT00418665|Secondary|Lenalidomide Dose Reduction and Delay Due to Thrombocytopenia|Occurrence of lenalidomide dose reduction and delay due to thrombocytopenia|Treatment period (up to 16 weeks)|Full Analysis Set, composed of all randomized participants||Participants|||Number
734522|NCT00418665|Primary|Occurrence of a Clinically Significant Thrombocytopenic Event|Occurrence of one or more clinically significant thrombocytopenic events, defined as either Common Terminology Criteria for Adverse Events (CTCAE) v. 3 grade 3 or 4 thrombocytopenia starting from week 3 of cycle 1 or receipt of platelet transfusions starting from week 1 of cycle 1 and continuing through the end of treatment visit.|Treatment period through interim follow-up visit (up to 16 weeks)|Full Analysis Set, composed of all randomized participants||Participants|||Number
734523|NCT00418691|Primary|Patient Cognitive Test Scores at End of Treatment Period|For cognitive assessment, set of widely used standardized psychometric instruments shown to be sensitive to neurotoxic effects of cancer treatment. Measures assess attention span (Digit Span), graphomotor speed (Digit Symbol), memory (Hopkins Verbal Memory Test-Revised), verbal fluency (Controlled Oral Words Association), visual motor scanning speed (Trail Making Test Part A), executive function (Trail Making Test Part B); motor speed and dexterity (Grooved Pegboard).|Baseline to end of Week 4 treatment period||||||
734524|NCT00418691|Primary|Mean Processing Speed Change From Baseline in the Trail-making Test Part A Score|'Trail Making Test Part A' is a neuropsychological test of visual attention and task switching, administered to measure processing speed, timed as participants follow “trail” made by consecutive numbers (1,2,3, etc.). The test is finished as quickly as possible, and the time taken to complete the test used as the primary performance metric (in seconds). Maximum time allowed is 300 seconds. A lower change score indicates improvement. Participants tested before starting study medication and 4-5 weeks later while on study medication, reflected in a z score (deviations from population mean).|Baseline to 4-5 weeks on study medication|Analysis were per protocol. The z-score reflects how many standard deviations above or below the population mean a raw score is for each participant.||z-scores||Standard Deviation|Mean
734525|NCT00418717|Secondary|Area Under the Concentration-Time Curve (AUC)|AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. In this analysis, the AUC is compared for 2 different treatment regimens (used sequentially by the same patient population): Treatment Period A: ETN 25 mg BW (at week 4) vs Treatment Period B: ETN 50 mg QW (at week 12). Blood samples were taken on day 0 of PK analysis and collected every day after for 7 days for weeks 4 and 12.|7 days after week 4 and 7 days after week 12|The analysis population was the Pharmacokinetic (PK) subset, which included all patients who completed the 25 mg BW dose treatment period, received at least 1 dose of 50 mg QW and elected to participate in the PK assessment. Data on observed cases: 18 patients from ETN 25 mg BW (week 4) and 17 patients from ETN 50 mg QW (week 12).||ug*Day/mL||Standard Deviation|Mean
734526|NCT00418717|Primary|Disease Activity Score Using 28-joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4ESR) by Treatment Period.|DAS28-4ESR is a clinical index of rheumatoid arthritis disease activity based on information from swollen joints, tender joints, acute phase response (Erythrocyte Sedimentation Rate) and general health. DAS28-4ESR scores range from 0 - 10, where a score of less than or equal to 3.2 implies well controlled disease and greater than or equal to 5.1 implies active disease. In this analysis, the DAS28-4ESR is compared for 2 different treatment regimens (used sequentially by the same patient population): Treatment Period A: ETN 25 mg BW (at week 4) vs Treatment Period B: ETN 50 mg QW (at week 12).|weeks 4 and 12|The analysis population was modified intent to treat (mITT), which included all patients who completed the 25 mg BW dose treatment period and received at least 1 dose of 50 mg OW. Data on observed cases: 41 patients from ENT 25 mg BW (week 4) and 39 patients from ETN 50 mg OW (week 12).||units on scale||Standard Deviation|Mean
734528|NCT00418834|Other Pre-specified|Percent Change From Baseline in Ratio of Highly Selective C-Reactive Protein (Hs-CRP) at Week 6||Baseline and Week 6|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
734529|NCT00418834|Other Pre-specified|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 12||Baseline and Week 12|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
734530|NCT00418834|Other Pre-specified|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6||Baseline and Week 6|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
734531|NCT00418834|Other Pre-specified|Percent Change From Baseline in Apo Lipoprotein B (Apo B):Apo Lipoprotein A-I (Apo A-I) Ratio at Week 12||Baseline and Week 12|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
734532|NCT00418834|Other Pre-specified|Percent Change From Baseline in Apo Lipoprotein B (Apo B):Apo Lipoprotein A-I (Apo A-I) Ratio at Week 6||Baseline and Week 6|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
734533|NCT00418834|Other Pre-specified|Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 12||Baseline and Week 12|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
734534|NCT00418834|Other Pre-specified|Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6||Baseline and Week 6|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
734535|NCT00418834|Other Pre-specified|Percent Change From Baseline in Total Cholesterol (TC):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 12||Baseline and Week 12|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
734536|NCT00418834|Other Pre-specified|Percent Change From Baseline in Total Cholesterol (TC): High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6||Baseline and Week 6|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
734537|NCT00418834|Other Pre-specified|Percent Change From Baseline in Apo Lipoprotein A-I (Apo A-I) at Week 12||Baseline and Week 12|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
734538|NCT00418834|Other Pre-specified|Percent Change From Baseline in Apo Lipoprotein A-I (Apo A-I) at Week 6||Baseline and Week 6|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
734539|NCT00418834|Other Pre-specified|Percent Change From Baseline in Apo Lipoprotein B (Apo B) at Week 12||Baseline and Week 12|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
734540|NCT00418834|Other Pre-specified|Percent Change From Baseline in Apo Lipoprotein B (Apo B) at Week 6||Baseline and Week 6|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
734541|NCT00418834|Other Pre-specified|Percent Change From Baseline in Triglycerides (TG) at Week 12||Baseline and Week 12|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
734542|NCT00418834|Other Pre-specified|Percent Change From Baseline in Triglycerides (TG) at Week 6||Baseline and Week 6|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
734543|NCT00418834|Other Pre-specified|Percent Change From Baseline in Total Cholesterol (TC) at Week 12||Baseline and Week 12|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
734544|NCT00418834|Other Pre-specified|Percent Change From Baseline in Total Cholesterol (TC) at Week 6||Baseline and Week 6|"Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL)
value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis."||Percent Change||95% Confidence Interval|Least Squares Mean
734545|NCT00418834|Other Pre-specified|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12||Baseine and Week 12|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
734546|NCT00418834|Other Pre-specified|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6||Baseline and Week 6|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
734547|NCT00418834|Other Pre-specified|Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12||Baseline and Week 12|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL)value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
734548|NCT00418834|Other Pre-specified|Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 6||Baseline and Week 6|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
734549|NCT00418834|Secondary|Number of Patients Who Achieved LDL-C<100 mg/dL for Patients Without AVD and LDL-C<70 mg/dL for Patients With AVD at Week 12||Week 12|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Participants|||Number
734550|NCT00418834|Secondary|Number of Patients Who Achieved LDL-C <100 mg/dL for Patients Without Atherosclerotic Vascular Disease (AVD) and LDL-C <70 mg/dL for Patients With Atherosclerotic Vascular Disease (AVD) at Week 6||Week 6|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Participants|||Number
734551|NCT00418834|Secondary|Number of Patients Who Achieved Low Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 12||Week 12|"Full Analysis Set (FAS): The FAS
population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL)
value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind
study medication were included in the analysis."||Participants|||Number
734552|NCT00418834|Secondary|Number of Patients Who Achieved Low Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 6||Week 6|"Full Analysis Set (FAS): The FAS population
includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at
least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication
were included in the analysis."||Participants|||Number
734553|NCT00418834|Secondary|Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12||Baseline and Week 12|"Full Analysis Set (FAS): The FAS
population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL)
value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind
study medication were included in the analysis."||Percent Change||95% Confidence Interval|Least Squares Mean
734554|NCT00418834|Primary|Percent Change From Baseline in LDL-C at Week 6||Baseline and Week 6|"Full Analysis Set (FAS): The FAS population
includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at
least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication
were included in the analysis."||Percent Change||95% Confidence Interval|Least Squares Mean
734555|NCT00418886|Secondary|Longitudinal Analysis of Average Symptom Burden Index (ASBI) Score|"The longitudinal data analysis will include all non-missing visit scores and the model will include only the first 12 weeks of data. ASBI is an average of the six symptom visual analogue patient scales from none (0 mm) to as much as it could be (100 mm)."|ASBI is a score taken from the Lung Cancer Symptom Scale (LCSS) questionnaires administered every 3 weeks after randomisation|||mms on a visual analogue scale||Standard Error|Least Squares Mean
734556|NCT00418886|Secondary|Longitudinal Analysis of Lung Cancer Symptom Scale (LCSS) Total Score|"The longitudinal data analysis will include all non-missing visit scores and the model will include only the first 12 weeks of data. LCSS total score is an average of all nine visual analogue patient scales from none (0 mm) to as much as it could be (100 mm)"|LCSS questionnaires are to be administered every 3 weeks after randomisation|||mms on a visual analogue scale||Standard Error|Least Squares Mean
734557|NCT00418886|Secondary|Time to Deterioration of Disease-related Symptoms (TDS) by Average Symptom Burden Index (ASBI) Score|Time to deterioration is defined as the interval from the date of randomization to the first assessment of worsened without an improvement in the next 21 days. A deterioration in symptoms is defined as a single visit assessment of ‘worsened’ with no visit assessment of ‘improved’ within the next 21 days. The ASBI is derived from 6 of LCSS’s 9 items|ASBI is a score taken from the LCSS questionnaires which are to be administered every 3 weeks after randomisation|||weeks||95% Confidence Interval|Median
734558|NCT00418886|Secondary|Time to Deterioration of Disease-related Symptoms (TDS) by Lung Cancer Symptom Scale (LCSS) Total Score|TDS is the interval from the date of randomization to the first assessment of worsened without an improvement in the next 21 days. A deterioration in symptoms is defined as a single visit assessment of ‘worsened’ with no visit assessment of ‘improved’ within the next 21 days. The LCSS scale measures changes in symptoms associated with lung cancer.|LCSS questionnaires are to be administered every 3 weeks after randomisation|||weeks||95% Confidence Interval|Median
734559|NCT00418886|Secondary|Duration of Response (DoR)|Response is defined as a confirmed best objective response of CR or PR. Duration of response is defined as time from the date of first documented response until date of documented progression or death in the absence of disease progression (provided death is within 3 months of last RECIST assessment)|RECIST tumour assessments carried out every 6 weeks (+/- 3 days) from randomisation until objective progression|||weeks||95% Confidence Interval|Median
734560|NCT00418886|Secondary|Disease Control Rate (DCR)|Disease control rate is defined as the number of patients who achieved disease control at 6 weeks following randomisation. Disease control at 6 weeks is defined as a best objective response of complete response (CR), partial response (PR) or stable disease (SD) >= 6 weeks|RECIST tumour assessments carried out every 6 weeks (+/- 3 days) from randomisation until objective progression|||Percentage of Participants|||Number
734561|NCT00418886|Secondary|Objective Response Rate (ORR)|"The ORR is the number of patients that are responders ie those patients with a confirmed best objective response of complete response (CR) or partial response (PR) as defined by RECIST criteria.
The categories for best objective response are CR, PR, stable disease (SD)>= 6 weeks, progressive disease (PD) or NE."|Each patient was assessed for objective response from the sequence of RECIST scan data up to data cut off. RECIST tumour assessments carried out every 6 weeks (+/- 3 days) from randomisation until objective progression|||Percentage of Participants|||Number
734562|NCT00418886|Secondary|Overall Survival (OS)|Overall survival is defined as the time from date of randomization until death. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive (ie their status must be known at the censored date and should not be lost to follow up or unknown).|Time to death in months|||months||95% Confidence Interval|Median
734563|NCT00418886|Primary|Progression-Free Survival (PFS) in the Female Population|Median time (in weeks) from randomisation until objective disease progression or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment|RECIST tumour assessments carried out every 6 weeks (+/- 3 days) from randomisation until objective progression|||weeks||95% Confidence Interval|Median
734564|NCT00418886|Primary|Progression-Free Survival (PFS) in the Overall Population|Median time (in weeks) from randomisation until objective disease progression or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment|RECIST tumour assessments carried out every 6 weeks (+/- 3 days) from randomisation until objective progression|||weeks||95% Confidence Interval|Median
734565|NCT00418938|Secondary|Duration of Response|Duration of response is defined as time from first confirmed objective response to disease progression per modified RECIST version 1.0 (by central assessment).|From randomization up to 65 months.|Analysis population include all enrolled subjects who received at least one dose of study therapy, who had at least one baseline uni-dimensionally measurable target lesion based on central (and investigator, respectively) assessment using a modified RECIST criteria version 1.0, and who had evaluable KRAS status.||months||95% Confidence Interval|Median
734566|NCT00418938|Secondary|Disease Control|Disease control is defined as incidence of objective response or stable disease on study up to starting a new anti-tumor therapy.|From randomization up to 65 months.|Analysis population include all enrolled subjects who received at least one dose of study therapy, who had at least one baseline uni-dimensionally measurable target lesion based on central (and investigator, respectively) assessment using a modified RECIST criteria version 1.0, and who had evaluable KRAS status.||% of participants||95% Confidence Interval|Number
734567|NCT00418938|Secondary|Time to Progression|Time to progression is defined as time from the date of randomization to the date of radiographic disease progression per modified RECIST version 1.0 (per central assessment).|From randomization up to 65 months.|Analysis population include all enrolled subjects who received at least one dose of study therapy and do not include subjects with unevaluable KRAS status.||months||95% Confidence Interval|Median
734568|NCT00418938|Secondary|Time to Response|Time to response is defined as time from the date of randomization to the date of first confirmed objective response|From randomization up to 65 months.|Analysis population include all enrolled subjects who received at least one dose of study therapy, who had at least one baseline uni-dimensionally measurable target lesion based on central (and investigator, respectively) assessment using a modified RECIST criteria version 1.0, and who had evaluable KRAS status.||months||Inter-Quartile Range|Median
734569|NCT00418938|Secondary|Objective Response Rate|Objective response rate is defined as incidence of either a confirmed complete response (CR) or partial response (PR) on study up to starting a new anti-tumor therapy and will be based on modified RECIST version 1.0 (responder) by central assessment.|From randomization up to 65 months.|Analysis population include all enrolled subjects who received at least one dose of study therapy, who had at least one baseline uni-dimensionally measurable target lesion based on central (and investigator, respectively) assessment using a modified RECIST criteria version 1.0, and who had evaluable KRAS status.||% of patients||95% Confidence Interval|Number
734570|NCT00418938|Secondary|Overall Survival|Overall survival is defined as time from the date of randomization to the date of death due to any cause. Subjects who have not died or are lost to follow-up at the analysis cutoff date will be censored at their last contact date.|From randomization up to 65 months.|Analysis population include all enrolled subjects who received at least one dose of study therapy and do not include subjects with unevaluable KRAS status.||months||95% Confidence Interval|Median
734571|NCT00418938|Primary|Progression-free Survival (PFS)|Progression-free survival is defined as time from the date of randomization to the date of first progression per modified RECIST version 1.0 (based on central review of the radiographic scans), or death within 60 days after the last evaluable tumor assessment or randomization date (whichever is later).|From randomization up to 65 months.|Analysis population include all enrolled subjects who received at least one dose of study therapy and do not include subjects with unevaluable KRAS status.||months||95% Confidence Interval|Median
734572|NCT00418951|Primary|Number of Participants With Invasive Fungal Infection|Endpoint was whether participant had an invasive fungal infection or not, a potentially fatal complication with leukemia patients. Efficacy defined as absence of proven and probable fungal infection. Probable fungal infection is: 1) Positive radiographic findings consistent with fungal infections documented on CT imaging: Lower respiratory tract infection: halo sign, air crescent-sign, or cavity within areas of consolidation; Sinus: erosion of sinus walls or extension of infection to neighboring structures, extensive skull base destruction; and/or 2) Two positive galactomannan index test.|35 days from the start of therapy for induction participants and 42 days for salvage participants.|Outcome evaluability required at least two doses of study drug.||participants|||Number
734573|NCT00418964|Secondary|Percentage Distal Femoral Bone Mineral Density (BMD)Decrease|% BMD decrease of distal femur of injured side with reference to the BMD at day 1 after surgery|1 year||||||
734574|NCT00418964|Primary|International Knee Documentation Committee (IKDC)Knee Form 2000 Score|It is a score on a scale from 0 to 100. It is a knee-specific measure of symptoms, function and sports activity of subjects based on self-report. 0 represents the worst while 100 represents the best score. The higher the score, the better the knee function.|1 year|||Score on a scale||Standard Deviation|Mean
734575|NCT00418977|Primary|Body Mass Index (BMI) Z-score|Z-score was calculated using the Baylor College of Medicine Children's Nutrition Research Center's online BMI calculator|up to 1 year|||z-score||Standard Deviation|Mean
734576|NCT00418977|Secondary|BMI Percentile|Body Mass Index (BMI) percentile. This is not a primary outcome variable.|up to 1 year|||percentile||Standard Deviation|Mean
734577|NCT00418977|Secondary|BMI|body mass index. This variable informs the calculation of the outcome variable of BMI Z-score.|up to 1 year|||kg/m^2||Standard Deviation|Mean
734578|NCT00418977|Secondary|Weight|This variable informs the calculation of the outcome variable of BMI Z-score.|up to 1 year|||pounds||Standard Deviation|Mean
734579|NCT00418977|Secondary|Height|This variable informs the calculation of the outcome variable of BMI Z-score.|up to 1 year|||inches||Standard Deviation|Mean
734580|NCT00419003|Secondary|Efficacy of Lamotrigine in Decreasing IV Ketamine Psychotomimetic Side Effects|Response rate and side effect differences to IV ketamine infusion based on lamotrigine and placebo pretreatment groups|24, 48, or 72-hrs||||||
734581|NCT00419003|Primary|Montgomery-Asberg Depression Rating Scale (MARDS) Score (Acute Response to IV Ketamine in Patients With Treatment Resistant Major Depression)|Montgomery-Asberg Depression Rating Scale, each of the ten items can be scored from 0 (absence of symptoms to 6 most severe) and has a total score range of 0-60. A lower score on a MADRS indicates a less severe depression. The primary outcome for the initial phase of the trial was the 24-h MADRS score, which included all 10 MADRS items.|24 Hours|||scores on a scale||95% Confidence Interval|Mean
734582|NCT00419094|Secondary|The Cumulative Exit Rate at 112 Days for the Keppra XR 1000 mg Group After the Beginning of the Previous Antiepileptic Drug (AED) Tapering Phase|Keppra XR 1000 mg arm was not intended for inferential analysis (planned 3 to 1 randomization, Keppra XR 2000 mg: 1000 mg). The Exit Rate was based on the duration between the start date of previous AED tapering to the earliest date an exit crterion was met. Subjects who prematurely discontinued for reasons unrelated to exit criteria were censored as of the last dose of study medication. Subjects who completed the study without meeting an exit criterion were censored as of Day 112.|112 days|Of the 57 (Keppra 1000 mg) subjects randomized, 54 subjects entered the Previous Antiepileptic Drug Tapering Phase and were included in the Efficacy Population.||proportion of subjects||95% Confidence Interval|Number
734583|NCT00419094|Secondary|The Cumulative Rate of Exit Events Due to Any Reasons at 112 Days After the Beginning of Previous Antiepileptic Drug (AED) Tapering Phase|The cumulative exit event rate at Day 112 was calculated using Kaplan Meier methods. The exit event rate estimate was based on the duration between the start date of previous AED tapering to the earliest date an exit event occured. Subjects who completed the study without having an exit event were censored as of Day 112.|112 days|Of the 171 (Keppra 2000 mg) subjects randomized, 158 subjects entered the Previous Antiepileptic Drug Tapering Phase and were included in the Efficacy Population. Evaluated for Keppra XR 2000 mg/day only.||proportion of subjects||95% Confidence Interval|Number
734584|NCT00419094|Secondary|The Cumulative Rate of Exit Events, Which Include Discontinuation Due to Exit Criteria, Withdrawal Due to Adverse Events (AE) and Withdrawal Due to Lack of Efficacy, at 112 Days After the Beginning of Previous Antiepileptic Drug (AED) Tapering Phase|The cumulative exit event rate at Day 112 was calculated using Kaplan Meier methods. The exit event rate estimate was based on the duration between the start date of previous AED tapering to the earliest date an exit event occured. Subjects who prematurely discontinued for reasons unrelated to exit criteria, adverse event, or lack of efficacy were censored as of the last dose of study medication. Subjects who completed the study without having an exit event were censored as of Day 112.|112 days|Of the 171 (Keppra 2000 mg) subjects randomized, 158 subjects entered the Previous Antiepileptic Drug Tapering Phase and were included in the Efficacy Population. Evaluated for Keppra XR 2000 mg/day only.||proportion of subjects||95% Confidence Interval|Number
734585|NCT00419094|Primary|The Cumulative Exit Rate at 112 Days After the Beginning of the Previous Antiepileptic Drug (AED) Tapering Phase|Cumulative exit rate at day 112, based on the duration between start date of previous AED tapering to the earliest date exit criterion was met; calculated using Kaplan Meier Methods. Subjects prematurely discontinued for reasons unrelated to exit criteria were censored as of last dose of study drug. Subjects who completed without meeting exit criteria were censored at Day 112. Exit criteria include increase in seizure frequency, severity, duration, status epilepticus, or new generalized seizure. Upper 95% 2-sided confidence limit for exit rate is compared to the historical control rate: 0.678.|112 days|Of the 171 (Keppra 2000 mg) subjects randomized, 158 subjects entered the Previous Antiepileptic Drug Tapering Phase and were included in the Efficacy Population. Primary Efficacy analysis was conducted for the Keppra XR 2000 mg/day group only.||proportion of subjects||95% Confidence Interval|Number
734586|NCT00419120|Secondary|Overall Safety Profile - Number of Participants Experiencing an Adverse Event|clinical evaluation of adverse events, laboratory parameters and urinary imaging to assess any safety issues emerging from this technology and to allow a comparison of a safety profile with standard of care enterocystoplasty. Please refer to the Adverse Event section for detailed information.|periodically within first 12 months as well as during long term follow up out to 5 years|||participants|||Number
734587|NCT00419120|Primary|Number of Responders as Assessed by Compliance|Efficacy of the autologous neo-bladder construct as assessed by a responder analysis (comparing each patient's baseline with 12 month data). Improvement in compliance (i.e. improved bladder pressure/volume relationship) was measured by urodynamics at predetermined bladder pressure points. This was coupled with an assessment of clinical benefit and used to determine responders versus non-responders|12 months|The analysis population of the primary outcome measure is the all implanted population (Intent to Treat - ITT). There was no imputation of analysis measures.||participants|||Number
734588|NCT00419159|Primary|The Number of Participants With Best Overall Response: Complete Response (CR, No Lesions), Partial Response (PR, 30% Decrease in Lesions), and Stable Disease (SD, None of the Above) According to Response Evaluation Criteria in Solid Tumors (RECIST)|"RECIST (Response Evaluation Criteria In Solid Tumors) is a set of published rules that define when cancer patients improve (respond), stay the same (stable) or worsen (progression) during treatments."|Imaging every 8 weeks|Full Analysis Set||Participants|||Number
734589|NCT00419159|Secondary|Biomarkers Predictive of Clinical Benefit on Everolimus (RAD001)||Screening and Day 1 of cycles 2, 3, 4 and end of treatment||||||
734590|NCT00419159|Secondary|Number of Patients Who Died, Had an Serious Adverse Event (SAE), Had Grade 3 to 4 Adverse Event (AE), Discontinued Due to an AE, or Had a Clinical Notable AE by Treatment (tr).|Toxicity assessed using the NIH-NCI Common Terminology Criteria for Adverse Events, Version 3.0 (CTCAEv3.0). On treatment death defined as deaths occurring no more than 28 days after the discontinuation of study treatment.|From the first day of treatment until 28 days after discontinuation of study treatment|Safety set analysis||Participants|||Number
734591|NCT00419159|Secondary|Overall Survival (OS)|Overall survival defined as the time from date of first study treatment to the date of death due to any cause.|Every 3 months|Overall Survival [OS] was analyzed in Full Analysis Set [FAS].||Months||95% Confidence Interval|Median
734592|NCT00419159|Secondary|Progression-free Survival (PFS)|Duration in months from the date of first study treatment to the date of the first documented disease progression or death due to any cause.|Imaging every 8 weeks|Progression- Free Survival (PFS) was analyzed in Full Analysis Set [FAS].||Months||95% Confidence Interval|Median
734593|NCT00419159|Primary|Disease Control Rate (DCR) and Objective Response Rate (ORR) According to the Response Evaluation Criteria in Solid Tumors (RECIST)|"RECIST (Response Evaluation Criteria In Solid Tumors) is a set of published rules that define when cancer patients improve (respond), stay the same (stable) or worsen (progression) during treatments.
Disease Control Rate (DCR) defined as the percentage of participants with Disease Control best overall response (complete response, partial response or stable disease)and Objective Response Rate (ORR) defined as the percentage of participants with best overall Objective Response (complete response or partial response)."|Imaging every 8 weeks|Per Protocol Set||Percentage of participants||95% Confidence Interval|Number
734594|NCT00419263|Secondary|Change From Baseline to Day 9 in Influenza Virus Titer|The change in viral titers was defined as the time-weighted change from baseline in log_10 tissue culture infective dose_50 (TCID_50/mL) and was summarized for each treatment group. The differences between the treatment groups were evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior. Specimens for virologic culture and determination of influenza virus TCID_50/mL were obtained on Day 2 (approximately 24 hours after treatment), on Day 3 (approximately 48 hours after treatment), on Day 5 (approximately 96 hours after treatment), and on Day 9 (approximately 192 hours after treatment).|Baseline and approximately 192 hours after treatment|The ITTI population included all subjects who were randomized, received study drug, and had proven influenza by any one of the following: culture, PCR, or paired serology showing ≥ 4-fold increase in antibody to influenza A or B. Subjects were analyzed according to the treatment to which they were randomized.||log10(TCID50/mL)||Full Range|Median
734595|NCT00419263|Secondary|Change From Baseline to Day 5 in Influenza Virus Titer|The change in viral titers was defined as the time-weighted change from baseline in log_10 tissue culture infective dose_50 (TCID_50/mL) and was summarized for each treatment group. The differences between the treatment groups were evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior. Specimens for virologic culture and determination of influenza virus TCID_50/mL were obtained on Day 2 (approximately 24 hours after treatment), on Day 3 (approximately 48 hours after treatment), on Day 5 (approximately 96 hours after treatment), and on Day 9 (approximately 192 hours after treatment).|Baseline and approximately 96 hours after treatment|The ITTI population included all subjects who were randomized, received study drug, and had proven influenza by any one of the following: culture, PCR, or paired serology showing ≥ 4-fold increase in antibody to influenza A or B. Subjects were analyzed according to the treatment to which they were randomized.||log10(TCID50/mL)||Full Range|Median
734596|NCT00419263|Secondary|Change From Baseline to Day 3 in Influenza Virus Titer|The change in viral titers was defined as the time-weighted change from baseline in log_10 tissue culture infective dose_50 (TCID_50/mL) and was summarized for each treatment group. The differences between the treatment groups were evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior. Specimens for virologic culture and determination of influenza virus TCID_50/mL were obtained on Day 2 (approximately 24 hours after treatment), on Day 3 (approximately 48 hours after treatment), on Day 5 (approximately 96 hours after treatment), and on Day 9 (approximately 192 hours after treatment).|Baseline and approximately 48 hours after treatment|The ITTI population included all subjects who were randomized, received study drug, and had proven influenza by any one of the following: culture, PCR, or paired serology showing ≥ 4-fold increase in antibody to influenza A or B. Subjects were analyzed according to the treatment to which they were randomized.||log10(TCID50/mL)||Full Range|Median
734620|NCT00419380|Secondary|Presence or Absence of Drainage in the Ear Canal and Fluid in the Middle Ear at the the Day-14 Visit.|Outcome measure data table represents the absence of drainage at day- 14|14 days|||Ear|||Number
734621|NCT00419380|Primary|Patency of the Tympanostomy Tube at the Day-14 Visit.||14 days|Analysis performed on ear level. Some participants received drops in both ears and thus both ears were included in analysis.||Ear|||Number
734597|NCT00419263|Secondary|Change From Baseline to Day 2 in Influenza Virus Titer|The change in viral titers was defined as the time-weighted change from baseline in log_10 tissue culture infective dose_50 (TCID_50/mL) and was summarized for each treatment group. The differences between the treatment groups were evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior. Specimens for virologic culture and determination of influenza virus TCID_50/mL were obtained on Day 2 (approximately 24 hours after treatment), on Day 3 (approximately 48 hours after treatment), on Day 5 (approximately 96 hours after treatment), and on Day 9 (approximately 192 hours after treatment).|Baseline and approximately 24 hours after treatment|The ITTI population included all subjects who were randomized, received study drug, and had proven influenza by any one of the following: culture, PCR, or paired serology showing ≥ 4-fold increase in antibody to influenza A or B. Subjects were analyzed according to the treatment to which they were randomized.||log10(TCID50/mL)||Full Range|Median
734598|NCT00419263|Secondary|Time to Resumption of Ability to Perform Usual Activities|The time to resumption of a subject’s self-assessed ability to perform his or her usual activities was estimated using the method of Kaplan-Meier. Differences between the treatment groups were assessed using the log rank statistic controlling for current smoking behavior. Subjects who were not able to resume performance of usual activities were censored at the time of the last assessment.|Up to 14 days|The ITTI population included all subjects who were randomized, received study drug, and had proven influenza by any one of the following: culture, PCR, or paired serology showing ≥ 4-fold increase in antibody to influenza A or B. Subjects were analyzed according to the treatment to which they were randomized.||Days||95% Confidence Interval|Median
734599|NCT00419263|Secondary|Time to Resolution of Fever|The time to resolution of fever (defined as the number of hours from initiation of study drug until temperature is less than 37.2 degrees C [99.0 degrees F] and no antipyretic medications had been taken in the previous 12 hours) was estimated using the method of Kaplan-Meier. Differences between the treatment groups were assessed using the log rank statistic controlling for current smoking behavior. Subjects who did not have resolution of fever were censored at the time of the last assessment. No adjustment for multiple comparisons was performed.|Up to 14 days|The ITTI population included all subjects who were randomized, received study drug, and had proven influenza by any one of the following: culture, PCR, or paired serology showing ≥ 4-fold increase in antibody to influenza A or B. Subjects were analyzed according to the treatment to which they were randomized.||Hours||95% Confidence Interval|Median
734600|NCT00419263|Primary|Time to Alleviation of Symptoms (Kaplan-Meier Estimate)|Descriptive statistics for the primary efficacy variables were tabulated by treatment group. Alleviation of symptoms was determined by data recorded in the Subject Diary. Treatment differences were assessed using a Cox Regression model with effects for current smoking behavior, treatment, and geographic region. Subjects who did not experience alleviation of symptoms were censored at the date of their last assessment. A Bonferroni adjustment for the primary comparisons of each active dose with placebo was performed.|Up to 14 days|The intent-to-treat infected (ITTI) population included all randomized subjects who received study drug and had proven influenza by culture, PCR, or paired serology showing ≥ 4-fold increase in antibody to influenza A or B. Of the 318 subjects in the ITTI population, one subject had insufficient data to determine Time to Alleviation of Symptoms.||Hours||95% Confidence Interval|Median
734601|NCT00419315|Secondary|Percent Days of Heavy Alcohol Use|This is a measure during the 6 month of the percentage of 30 days in which a subject had at least 1 day of heavy drinking as defined by drinking more than 4 standard drinks in a day (3 or more for women).|6 months|||percentage of heavy drinking days||Standard Deviation|Mean
734602|NCT00419315|Primary|Treatment Engagement|This measured the percentage of subjects who attended at least 2 clinical addiction sessions in a given month. The outcome presented is the percentage during the 6th month of the trial.|6 months|||percentage of participants engaged|||Number
734603|NCT00419341|Other Pre-specified|Rate of Mild, Moderate, or Severe Local Reactions|"In addition to the standard MedDRA System Organ Class (SOC) AE assignments, the category of 'local reactions' was defined to provide the possibility for a combined analysis of local reactions and included AEs of injection site reaction, injection site bruising, infusion site scab, injection site cyst, injection site eczema, injection site irritation, injection site nodule, and injection site pain.
Mild AE: Did not interfere with routine activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities."|For the duration of the study, up to 15 months|The ITT population included all subjects who were treated with IgPro20 during any study period.||local reactions per infusion|Participants||Number
734604|NCT00419341|Other Pre-specified|Rate of All AEs by Relatedness and Seriousness|The rate of AEs was the number of AEs over the number of infusions administered. At least possibly related AEs included possibly related AEs, probably related AEs, and related AEs.|For the duration of the study, up to 15 months|The ITT population included all subjects who were treated with IgPro20 during any study period.||AEs per infusion|Participants||Number
734605|NCT00419341|Other Pre-specified|Minimum Concentration (Cmin) of Total Serum IgG at Steady State||Week 28 ± 1 week of the treatment period|The PPK population included all subjects with the disease under study who fulfilled the requirements of the PK substudy, including PK sampling in a preceding study with IVIG (Privigen, CSL Behring), and fulfilling IgPro20 dosing requirements and providing adequate PK blood samples in the current study.||g/L||Standard Deviation|Mean
734606|NCT00419341|Secondary|Tmax at Steady State|Timepoint of maximum concentration (Cmax)|Week 28 ± 1 week of the treatment period|The PPK population included all subjects with the disease under study who fulfilled the requirements of the PK substudy, including PK sampling in a preceding study with IVIG (Privigen, CSL Behring), and fulfilling IgPro20 dosing requirements and providing adequate PK blood samples in the current study.||days||Full Range|Median
734607|NCT00419341|Secondary|Maximum Concentration (Cmax) of Total Serum IgG at Steady State||Week 28 ± 1 week of the treatment period|The PPK population included all subjects with the disease under study who fulfilled the requirements of the PK substudy, including PK sampling in a preceding study with IVIG (Privigen, CSL Behring), and fulfilling IgPro20 dosing requirements and providing adequate PK blood samples in the current study.||g/L||Standard Deviation|Mean
734608|NCT00419341|Secondary|Total Serum IgG Trough Levels|The IgG trough values per subject were aggregated to a median value, and then median values across subjects were summarized using descriptive statistics.|Every 4 weeks, throughout the 12-month efficacy period|The MITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with week 13) who had the disease under study.||g/L||Standard Deviation|Mean
734609|NCT00419341|Secondary|Use of Antibiotics for Infection Prophylaxis and Treatment|Annualized rate of days with antibiotics for infection prophylaxis and treatment. The annualized rate was based on the total number of days of antibiotic use for infection prophylaxis and treatment in the efficacy period, and the total number of subject study days for all subjects in the specified analysis population, and adjusted to 365 days.|Efficacy period: up to 12 months (week 13 to the completion visit)|The MITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with week 13) who had the disease under study.||days per subject year|Participants||Number
734610|NCT00419341|Secondary|Number of Days of Hospitalization Due to Infections|Total number of days of hospitalization due to infections for the specified analysis population|Efficacy period: up to 12 months (week 13 to the completion visit)|The MITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with week 13) who had the disease under study.||days|||Number
734611|NCT00419341|Secondary|Annualized Rate of Hospitalization Due to Infection|The annualized rate was based on the total number of days of hospitalization due to infection (N = 7) and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.|Efficacy period: up to 12 months (week 13 to the completion visit)|The MITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with week 13) who had the disease under study.||days per subject year|Participants||Number
734612|NCT00419341|Secondary|Number of Days Out of Work / School / Kindergarten / Day Care or Unable to Perform Normal Daily Activities Due to Infections|Total number of days out of work / school / kindergarten / day care or unable to perform normal daily activities due to infections, for the specified analysis population|Efficacy period: up to 12 months (week 13 to the completion visit)|The MITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with week 13) who had the disease under study.||days|||Number
734613|NCT00419341|Secondary|Annualized Rate of Days Out of Work / School / Kindergarten / Day Care or Unable to Perform Normal Daily Activities Due to Infections|The annualized rate was based on the total number of days out of work / school / kindergarten / day care or inability to perform normal activities due to infection (N = 71), and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.|Efficacy period: up to 12 months (week 13 to the completion visit)|The modified intention-to-treat (MITT) population included all subjects who were treated with IgPro20 during the efficacy period (starting with Week 13) who had the disease under study.||days per subject year|Participants||Number
734614|NCT00419341|Secondary|Number of Infection Episodes (Serious and Non-serious)|Total number of infections for the specified analysis population|Efficacy period: up to 12 months (week 13 to the completion visit)|The MITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with week 13) who had the disease under study.||infections|||Number
734615|NCT00419341|Secondary|Annualized Rate of Infection Episodes|The annualized rate was based on the total number of infection episodes occurring during the efficacy period (N = 96) divided by the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.|Efficacy period: up to 12 months (week 13 to completion visit)|The MITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with Week 13) who had the disease under study.||infection episodes per subject year|Participants|95% Confidence Interval|Number
734616|NCT00419341|Secondary|Annualized Rate of Clinically Documented SBIs (PPE Population)|"The annualized rate was based on the total number of SBIs and the total number of subject study days during the efficacy period for all subjects in the specified analysis population and adjusted to 365 days.
Potential SBIs included pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess. If an AE was identified as a potential SBI, the AE was adjudicated by a review committee to determine if the event fulfilled the predefined criteria for SBIs."|Efficacy period: up to 12 months (week 13 to the completion visit)|The Per Protocol Efficacy (PPE) population included all subjects who completed the 12-month efficacy period according to the protocol-defined requirements.||SBIs per subject year|Participants||Number
734617|NCT00419341|Secondary|Annualized Rate of Clinically Documented SBIs (ITT Population)|"The annualized rate was based on the total number of SBIs and the total number of subject study days during the study for all subjects in the specified analysis population and adjusted to 365 days.
Potential SBIs included pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess. If an AE was identified as a potential SBI, the AE was adjudicated by a review committee to determine if the event fulfilled the predefined criteria for SBIs."|For the duration of the study, up to 15 months|The Intention To Treat (ITT) population included all subjects who were treated with IgPro20 during any study period.||SBIs per subject year|Participants||Number
734618|NCT00419341|Primary|Area Under the Concentration-time Curve (AUC) of Total Serum Immunoglobulin G (IgG)|Evaluate non-inferiority of steady-state IgG area under the concentration-time curves standardized to a 7-day period (sAUCs) for subcutaneous immunoglobulin (SCIG) (IgPro20) versus the sAUC under intravenous immunoglobulin (IVIG) (Privigen) treatment. The sAUC under IVIG was taken from the same subjects in a preceding study (either ZLB03_002CR [NCT00168025] or ZLB05_006CR [NCT00322556]).|Measured during a single dosing interval after at least 12 weeks of stable subcutaneous (SC) dosing with IgPro20 treatment|The Per Protocol Pharmacokinetic (PPK) population included all subjects with the disease under study who fulfilled the requirements of the PK substudy, including PK sampling in a preceding study with IVIG (Privigen, CSL Behring), and fulfilling IgPro20 dosing requirements and providing adequate PK blood samples in the current study.||days*g/L||Standard Deviation|Mean
734619|NCT00419341|Primary|Annualized Rate of Clinically Documented Serious Bacterial Infections (SBIs) (MITT Population)|"The annualized rate was based on the total number of SBIs and the total number of subject study days during the efficacy period for all subjects in the specified analysis population and adjusted to 365 days.
Potential SBIs included pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess. If an adverse event (AE) was identified as a potential SBI, the AE was adjudicated by a review committee to determine if the event fulfilled the predefined criteria for SBIs."|Efficacy period: up to 12 months (week 13 to the completion visit)|The modified intention-to-treat (MITT) population included all subjects who were treated with IgPro20 during the efficacy period (starting with Week 13) who had the disease under study.||SBIs per subject year|Participants||Number
734622|NCT00419393|Secondary|Percentage of Subjects Remaining on Keppra XR Monotherapy From Study Entry Through 12 Months|Among subjects in the Efficacy (EFF) population entering the study on Keppra XR monotherapy and exposed for at least 6 months, is the percentage of subjects remaining on monotherapy treatment for at least 12 months.|Study entry through 12 months|Of the 190 subjects beginning the study, 49 are in the Efficacy (EFF) population, entered the study on Keppra XR monotherapy, and have been exposed to treatment for at least 12 months. The Efficacy population includes subjects that are in the Safety Set (SS) with at least one reported efficacy measure.||percentage of subjects|||Number
734623|NCT00419393|Secondary|Percentage of Subjects Remaining on Keppra XR Monotherapy From Study Entry Through 6 Months|Among subjects in the Efficacy (EFF) population entering the study on Keppra XR monotherapy and exposed for at least 6 months, is the percentage of subjects remaining on monotherapy treatment for at least 6 months.|Study entry through 6 months|Of the 190 subjects beginning the study, 139 are in the Efficacy (EFF) population, entered the study on Keppra XR monotherapy, and have been exposed to treatment for at least 6 months. The Efficacy population includes subjects that are in the Safety Set (SS) with at least one reported efficacy measure.||percentage of subjects|||Number
734624|NCT00419393|Primary|Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event During the Actual Treatment Period|An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.|Duration of the Treatment Period (6 months-2 years)|Of the 190 subjects beginning the study, 189 received at least one dose of study medication, placing them in the Safety Set (SS) analyzed here.||number of subjects|||Number
734625|NCT00419393|Primary|Number of Subjects Who Experienced at Least 1 Serious Treatment Emergent Adverse Event During the Actual Treatment Period (6 Months-2 Years)|A serious adverse event is any untoward medical occurrences in a subject administered study treatment, whether or not the event is related to treatment, with at least one of the follow outcomes: death, life-threatening, initial inpatient hospitalization or prolongation of hospitalization, significant or persistent disability/incapacity, congenital anomaly/birth defect, or an important medical event that may jeopardize the subject and require a medical/surgical intervention.|Duration of the Treatment Period (6 months-2 years)|Of the 190 subjects beginning the study, 189 received at least one dose of study medication, placing them in the Safety Set (SS) analyzed here.||number of subjects|||Number
734626|NCT00419393|Primary|Number of Subjects Who Experienced at Least 1 Treatment Emergent Adverse Event During the Actual Treatment Period (6 Months-2 Years)|An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.|Duration of the Treatment Period (6 months-2 years)|Of the 190 subjects beginning the study, 189 received at least one dose of study medication, placing them in the Safety Set (SS) analyzed here.||number of subjects|||Number
734627|NCT00419445|Primary|To Assess the Safety and Tolerability of GTS21 (25 mg Tid, 75 mg Tid, 150 mg Tid).|The proportion of subjects with Treatment Emergent Adverse Events.|Baseline to study completion|||% of subjects|||Number
734628|NCT00419744|Primary|Rate of Exacerbations Per Subject-year|Rate of exacerbations per subject-year|12 months|||Rate|||Number
734629|NCT00419744|Secondary|St. George's Respiratory Questionnaire (SGRQ) Score|Change from baseline in the SGRQ overall score, as calculated by averaging treatment period SGRQ scores and subtracting the baseline SGRQ scores. The SGRQ contains 3 domains: Symptoms (distress due to respiratory symptoms, 8 questions), Activity (disturbance of physical activity, 16 questions), and Impacts (overall impact on daily life and well-being, 26 questions). Lower scores are associated with less severe symptoms.|12 months|||Scores on a scale||Standard Deviation|Mean
734630|NCT00419744|Secondary|Use of Rescue Medication|Change from baseline in the use of beta-2 agonists, as calculated by averaging treatment period inhalations per day and subtracting the baseline number of inhalations per day.|12 months|||Number of inhalations||Standard Deviation|Mean
734631|NCT00419744|Secondary|Dyspnea Symptom Scores|Change from baseline of Dyspnea symptoms evaluated using the breathlessness diary, a 5-point Likert-type scale, ranging from 0 to 4 with higher scores indicating a more severe manifestation of the Dyspnea symptom. Change from baseline was calculated by averaging treatment period Dyspnea scores and subtracting the baseline Dyspnea scores.|12 months|||Scores on a scale||Standard Deviation|Mean
734632|NCT00419744|Secondary|Evening PEF|Change in evening PEF from baseline to the average of the randomized treatment period, as calculated by averaging treatment period PEF values and subtracting the baseline evening PEF value.|12 months|||L/min||Standard Deviation|Mean
734633|NCT00419744|Secondary|Morning Peak Expiratory Flow (PEF)|Change in morning PEF from baseline to the average of the randomized treatment period, as calculated by averaging treatment period PEF values and subtracting the baseline morning PEF value.|12 months|||L/min||Standard Deviation|Mean
734634|NCT00419744|Secondary|Pre-dose Forced Expiratory Volume in 1 Second (FEV1)|Change in pre-dose FEV1 from baseline to the average of the randomized treatment period, as calculated by averaging treatment period FEV1 values and subtracting the pre-dose value.|12 months|||Liters (L)||Standard Deviation|Mean
734635|NCT00419744|Primary|Total Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Patient-treatment Year|Number of COPD-related exacerbations per patient-treatment year. COPD-related exacerbation was defined as worsening COPD that required a course of oral steriods for treatment and/or hospitalization.|12 months|||Exacerbations|||Number
734636|NCT00419757|Secondary|Patient Satisfaction With Asthma Medication (PSAM) in Term of Domain: Comparison With Other Medications|Mean scores (5-points scale, where 1-means the most positive opinion and 5-the most negative opinion) were calculated for items in domain. 6-point response options were scored on a 0±100 scale, where 100 represented the highest level of satisfaction and 0 the lowest level of satisfaction.|Week 12|Only subjects 18 years and older, who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.||Units on a scale||Standard Error|Least Squares Mean
734649|NCT00419757|Secondary|"Percentage of Participants With Withdrawals Due to Pre-defined Asthma Events"|"Percentage of participants with Withdrawals Due to Pre-defined Asthma Events as recorded in CRF. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated."|12 weeks|Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.||Percentage of Participants|||Number
734637|NCT00419757|Secondary|Patient Satisfaction With Asthma Medication (PSAM) in Term of Domain: Overall Perception of Medication|Mean scores (6 or 5-points scale, where 1-means the most positive opinion and 5/6-the most negative opinion) were calculated for items in domain. 6-point response options were scored on a 0±100 scale, where 100 represented the highest level of satisfaction and 0 the lowest level of satisfaction.|Week 12|Only subjects 18 years and older, who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.||Units on a scale||Standard Error|Least Squares Mean
734638|NCT00419757|Secondary|Patient Satisfaction With Asthma Medication (PSAM) in Term of Domain: Control Relief Index|Mean scores (6-points scale, where 1-means the most positive opinion and 6-the most negative opinion) were calculated for items in domain. 6-point response options were scored on a 0±100 scale, where 100 represented the highest level of satisfaction and 0 the lowest level of satisfaction.|Week 12|Only subjects 18 years and older, who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.||Units on a scale||Standard Error|Least Squares Mean
734639|NCT00419757|Secondary|Physician Global Assessment|"The assessment was made using a 5-point scale with 1=much better, 2=somewhat better, 3=comparable, 4=somewhat worse, and 5=much worse transformed to a binary variable with points 1and 2 combined as “Yes” and points 3, 4, 5 as No. Percent of Participants that gave positive responses."|Baseline and week 12|Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.||Perscentage of Participants|||Number
734640|NCT00419757|Secondary|Subject Global Assessment|"The assessment was made using a 5-point Likert scale with 1=much better, 2=somewhat better, 3=comparable, 4=somewhat worse, and 5=much worse transformed to a binary variable with points 1 and 2 combined as “Yes” and points 3, 4, 5 as No. Percent of Participants that gave positive responses."|Baseline and week 12|Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.||Percent of Participants|||Number
734641|NCT00419757|Secondary|Change From Baseline in Symptom-free Days Over 12 Weeks of Treatment|Change from baseline in percentage of symptom-free days over 12 weeks of treatment, with baseline value as covariate. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.|Baseline (run-in) and throughout 12 weeks|Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.||Percentage of days||Standard Error|Least Squares Mean
734642|NCT00419757|Secondary|Change From Baseline in Rescue-free Days Over 12 Weeks of Treatment|Change from baseline in percentage of rescue-free days over 12 weeks of treatment, with baseline value as covariate. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.|Baseline (run-in) and throughout 12 weeks|Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.||Percentage of days||Standard Error|Least Squares Mean
734643|NCT00419757|Secondary|Change From Baseline in Rescue Medication Use Over 12 Weeks of Treatment|Change from baseline in rescue medication use over 12 weeks of treatment with baseline value as covariate. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.|Baseline (run-in) and throughout 12 weeks|Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.||puffs/day||Standard Error|Least Squares Mean
734644|NCT00419757|Secondary|Change in Asthma Related Awakenings Free Nights, From Baseline Through 12 Weeks|Change from baseline in percentage of nights with awakenings due to asthma over 12 weeks of treatment, with baseline value as covariate.|Baseline (run-in) and throughout 12 weeks|Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.||Percentage of nights||Standard Error|Least Squares Mean
734645|NCT00419757|Secondary|Change in Daytime Asthma Symptom Score From Baseline Through 12 Weeks|"Change from baseline in average of daily scores for daytime asthma over 12 weeks of treatment, with baseline value as covariate.
Daily scale:
0 = No symptoms
1 = Mild symptoms
2 = Moderate symptoms
3 = Severe symptoms"|Baseline (run-in) and throughout 12 weeks|Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.||Units on a scale||Standard Error|Least Squares Mean
734646|NCT00419757|Secondary|Change in Nighttime Asthma Symptom Score From Baseline Through 12 Weeks|"Change from baseline in average of daily scores for nighttime asthma over 12 weeks of treatment, with baseline value as covariate.
Daily scale:
0 = No symptoms
1 = Mild symptoms
2 = Moderate symptoms
3 = Severe symptoms"|Baseline (run-in) and throughout 12 weeks|Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.||Units on a scale||Standard Error|Least Squares Mean
734647|NCT00419757|Secondary|Change From Baseline in a Evening Peak Expiratory Flow (PM PEF)|Change from baseline (average of daily records over the 14 days of run-in) to the average of daily records over the treatment period of 12 weeks with baseline as covariate. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.|Baseline (run-in) and throughout 12 weeks|Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.||Liters/minutes||Standard Error|Least Squares Mean
734648|NCT00419757|Secondary|Changes Pre-dose Forced Expiratory Volume in 1 Second (FEV1)|Changes in pre-dose FEV1 from baseline to the average value over the treatment period, with baseline value as covariate. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.|Baseline, 2, 6 and 12 weeks|Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.||Liters||Standard Error|Least Squares Mean
734677|NCT00426660|Primary|Percentage of Participants With All Causality Treatment-emergent Adverse (AEs) Events by Gender|Treatment-emergent AEs by gender that occurred up to 30 days after the last dose of study medication.|Baseline up to Week 144|Safety analysis set; n = number of participants evaluable for adverse events.||percentage of participants|||Number
734650|NCT00419757|Secondary|Percentage of Participants With Pre-defined Asthma Events|Asthma Events, defined as any of: decrease in lung function (FEV1 or AM PEF), use of rescue medication over maximum allowed per day, night awakening requiring use of rescue medication, exacerbation of asthma requiring medical assistance, use of not allowed asthma medication|12 weeks|Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.||Percentage of Participants|||Number
734651|NCT00419757|Primary|Morning Peak Expiratory Flow (AM PEF)|Change from baseline (average of daily records over the 14 days of run-in) to the average of daily records over the treatment period of 12 weeks, with baseline value as covariate.|Baseline (run-in) and throughout 12 weeks|Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.||Liters/minutes||Standard Error|Least Squares Mean
734652|NCT00419770|Primary|Total Adverse Events||30 Days After End of Therapy|||Events|||Number
734653|NCT00419770|Secondary|Survival, Radiographic Improvement, Clinical Response, Time to Survival, Deferasirox vs. Free Iron Level Correlation||Up to 90 days||||||
734654|NCT00419770|Secondary|Deferasirox Pharmacokinetic and Pharmacodynamic Parameters||7 days||||||
734655|NCT00419770|Primary|Global Response Rate (Composite of Clinical and Radiographic Response) at End of Study Drug Administration, as Determined by a Blinded Adjudication Committee||14 days||||||
734656|NCT00419770|Primary|Safety and Tolerability of Adjunctive Deferasirox Therapy in Patients Being Treated With LAmB for Mucormycosis||14 days||||||
734657|NCT00426556|Secondary|Phase II: Overall Survival (OS)|Overall survival (OS) is defined as the time from start of treatment to the date of death due to any cause. If a patient is not known to have died, survival was censored at the last date of contact. OS was to be reported at extension and after 3-year follow-up. The Kaplan-Meier median was used to analyze the OS.|every 3 months until death|The Full Analysis Set (FAS) consisted of all patients who received a least one dose of any one compound of the study treatment. Patients were analyzed according to the everolimus dose level to which they enrolled.||Months||95% Confidence Interval|Median
734658|NCT00426556|Secondary|Phase II: Progression Free Survival (PFS)|PFS is defined as the time from start of treatment to the date of first documented progression or death due to any cause. If a patient has not had an event, PFS will be censored at the date of last adequate tumor assessment.|every 8 - 9 weeks until disease progression or a new lesion is identified|The Full Analysis Set (FAS) consisted of all patients who received a least one dose of any one compound of the study treatment. Patients were analyzed according to the everolimus dose level to which they enrolled.||Months||95% Confidence Interval|Median
734659|NCT00426556|Secondary|Phase I: Best Overall Response (BOR)|BOR was determined based on investigator assessment of overall lesion response using RECIST criteria guidelines. BOR = objective responses rate (ORR), disease control rate (DCR) or clinical benefit rate (CBR). ORR = (complete response (CR) or partial response(PR); DCR = (CR or PR or Stable disease (SD); CBR = (CR or PR or SD >= 24 weeks).CR = Disappearance of all target lesions; PR = At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters; SD = Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for partial disease (PD). PD = At least a 20% increase in the sum of the longest diameter of all measured target lesions, taking as reference the smallest sum of longest diameter of all target lesions recorded at or after baseline.|every 8 - 9 weeks until disease progression or a new lesion is identified|The Full Analysis Set (FAS) consisted of all patients who received a least one dose of any one compound of the study treatment. Patients were analyzed according to the everolimus dose level to which they enrolled.||Percentage of Participants|||Number
734660|NCT00426556|Primary|Phase II: Overall Response Rate|The primary objective of this phase II study was to evaluate the efficacy of the dose level/regimen of everolimus recommended from the Phase I with trastuzumab and paclitaxel (PT) therapy in patients with HER2-overexpressing metastatic breast cancer whose disease progressed on/after trastuzumab mono-and/or combination therapy based on the evaluation of objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Objective response rate (ORR) was defined as the proportion of patients with a best overall response (BOR) of complete response (CR) or partial response (PR). Only patients with measurable disease (the presence of at least one measurable lesion) at baseline were included in the study. CR = Disappearance of all target lesions; PR = At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters.|every 8 - 9 weeks until disease progression or a new lesion is identified|The Full Analysis Set (FAS) consisted of all patients who received a least one dose of any one compound of the study treatment. Patients were analyzed according to the everolimus dose level to which they enrolled.||Percentage of Participants|||Number
734661|NCT00426660|Secondary|Number of Participants With Emergence of Resistance to Maraviroc as Defined by Genotypic Changes in the V3 Loop of Glycoprotein 120 (gp 120)|Virus from participants who experienced virologic failure was analyzed for resistance to maraviroc. Resistance testing was performed on archived samples of participants which were available pre-­treatment at time of virologic failure. For participants who met definition of virologic failure during the trial, the sequencing of the V3 loop of HIV-­1 viral envelope gp 120 was evaluated to identify any amino acid changes concomitant with decreased susceptibility to maraviroc.|Baseline up to Week 144|"Safety analysis set. Here, number of participants analyzed signifies those participants who were assessed for genotypic changes in the V3 Loop of glycoprotein 120 (gp 120)."||participants|||Number
734662|NCT00426660|Secondary|Number of Participants With Reduced Maraviroc Susceptibility as Defined by Change From Baseline to Time of Virologic Failure in Inhibitory Concentration of 50% (IC 50) and Presence of Plateau|Resistance to maravroc in viruses from participants failing therapy with R5 virus was investigated using the in vitro phenotypic (drug susceptibility) assay. The number of participants who failed with R5 virus were assessed successfully for maraviroc susceptibility at Baseline and Last on-­treatment (Week 144). Samples were analyzed for change from Baseline to time of virologic failure in IC 50 and presence of plateau. A maximal percent inhibition (MPI) <95% established as a plateau in inhibition at high concentrations of maraviroc was used to identify viruses which had reduced phenotypic susceptibility to maraviroc.|Baseline up to Week 144|"Safety analysis set. Here, number of participants analyzed signifies those participants who were assessed for maraviroc susceptibility."||participants|||Number
734663|NCT00426660|Secondary|Percentage of Participants With Change in Chemokine Co-receptor Tropism From Screening to Time of Virologic Failure|Tropism status (CCR5 [R5], CXCR4 [X4], Dual Mixed [DM], or Non-reportable [NR]) at Screening (Scr) and time of virologic failure (V fail). Virologic failure defined as: failure to achieve a reduction from baseline (BL) in HIV 1 RNA ≥0.5 log10 copies/mL by second viral load determination (unless viral load was below lower limit level of quantification [LLOQ]); or a ≥ 0.5 log10 increase from nadir in HIV 1 RNA after achieving HIV 1 RNA reduction from BL >0.5 log10 copies/mL; or a HIV 1 RNA level of >1000 copies/mL after having achieved a HIV 1 RNA level below LLOQ.|Screening up to Week 144|Safety analysis set; N = participants with virologic failure (VF). Abbreviations: Scr = screening, R5 = CCR5 tropic HIV-1, X4=CXCR4 tropic HIV-1, DM = dual mixed, NR = non-reportable, Missing = participants with VF who did not have tropism result within specified screening period (Scr missing: -42 days to Day 0) or at the time of VF.||percentage of participants|||Number
734664|NCT00426660|Secondary|Percentage of Participants With Changes in HIV-1 RNA Level in Participants Meeting the Definition of Virologic Failure|Reasons for virologic failure: A) failure to achieve a reduction in HIV-1 RNA>=0.5 log10 copies/ml from baseline (BL) by second viral load determination (unless below level of quantification [LOQ]); B) >=0.5 log10 increase from nadir in HIV-1 RNA after achieving an HIV-1 RNA reduction from BL >0.5 log10 copies/ml ; C) HIV-1 RNA >1000 copies/ml after having achieved an HIV-1 RNA below LOQ.|Baseline up to Week 144|Safety analysis set; N = number of participants with virologic failure.||percentage of participants|||Number
734665|NCT00426660|Secondary|Median Time to Virologic Failure|Computed as time from the first dose of study medication to the loss of virologic response. Virologic failure defined as: failure to achieve a reduction from baseline (BL) in HIV 1 RNA ≥ 0.5 log10 copies /mL by the second viral load determination (unless viral load was below the lower limit level of quantification [LLOQ]); or a ≥ 0.5 log10 increase from nadir in HIV 1 RNA after achieving a HIV 1 RNA reduction from BL >0.5 log10 copies/mL; or a HIV 1 RNA level of >1000 copies/mL after having achieved a HIV 1 RNA level below LLOQ.|Day 1 up to Week 144|Safety analysis set. N = number of participants with virologic failure. For the calculation of the time to virologic failure, any visits with no data were excluded. Participants who were not virologic failures were censored at the last available observation.||days||Inter-Quartile Range|Median
734666|NCT00426660|Secondary|Change From Baseline in CD8 Cell Count Percent|Change from baseline in CD8 cell count percent . If baseline value was not available, it was taken from immediate preceding non-missing value.|Baseline up to Week 144|Safety analysis set; n = number of participants contributing to summary statistic at given timepoint.||percentage of lymphocytes||Standard Deviation|Mean
734667|NCT00426660|Secondary|Change From Baseline in CD8 Cell Count|Change from baseline in cluster of differentiation 8 suppressor T cells (CD8) cell count. If baseline value was not available, it was taken from immediate preceding non-missing value.|Baseline up to Week 144|Safety analysis set; n = number of participants contributing to summary statistic at given timepoint.||cells/uL||Standard Deviation|Mean
734668|NCT00426660|Secondary|Change From Baseline in CD4 Cell Count Percent|Change from baseline in CD4 cell count percent . If baseline value was not available, it was taken from immediate preceding non-missing value.|Baseline up to Week 144|Safety analysis set; n = number of participants contributing to summary statistic at given timepoint.||percentage of lymphocytes||Standard Deviation|Mean
734669|NCT00426660|Secondary|Change From Baseline in CD4 Cell Count|Change from baseline in cluster of differentiation 4 helper T cells (CD4) cell count. If baseline value was not available, it was taken from immediate preceding non-missing value.|Baseline up to Week 144|Safety analysis set; n = number of participants contributing to summary statistic at given timepoint.||cells/uL||Standard Deviation|Mean
734670|NCT00426660|Secondary|Percentage of Participants With HIV-1 RNA Levels Below the Limit of Quantification: <50 Copies/mL|Limit of quantification defined as <50 copies/mL. Baseline value calculated as average of the screening and baseline values if both values were within 1 log 10 difference.|Baseline up to Week 144|Safety analysis set; n = number of participants contributing to summary statistic at given timepoint.||percentage of participants|||Number
734671|NCT00426660|Secondary|Percentage of Participants With HIV-1 RNA Levels Below the Limit of Quantification: <400 Copies/mL|Limit of quantification defined as <400 copies/mL. Baseline value calculated as average of the screening and baseline values if both values were within 1 log 10 difference.|Baseline up to Week 144|Safety analysis set; n = number of participants contributing to summary statistic at given timepoint.||percentage of participants|||Number
734672|NCT00426660|Secondary|Percentage of Participants With ≥1.0 log10 Reduction From Baseline in HIV 1 RNA|Defined as HIV-1 RNA levels < 400 copies/mL or at least 1.0 Log 10-decrease from baseline in HIV-1 RNA levels. Baseline value calculated as average of the screening and baseline values if both values were within 1 log10 difference.|Baseline up to Week 144|Safety analysis set; n = number of participants contributing to summary statistic at given timepoint.||percentage of participants|||Number
734673|NCT00426660|Secondary|Percentage of Participants With ≥0.5 log10 Reduction From Baseline in Human Immunodeficiency Virus 1 Ribonucleic Acid (HIV 1 RNA)|"Defined as HIV-1 RNA levels < 400 Copies/mL or at least 0.5 Log 10-decrease from baseline in HIV-1 RNA levels.
Baseline value calculated as average of the screening and baseline values if both values were within 1 log10 difference."|Baseline up to Week 144|Safety analysis set; n = number of participants contributing to summary statistic at given timepoint.||percentage of participants|||Number
734674|NCT00426660|Primary|Percentage of Participants With Treatment-emergent Averse Events (AEs) by Baseline Hepatitis B and Hepatitis C Virus Serology Status|Treatment emergent AEs by hepatis B and hepatitis C serology status that occurred up to 30 days post last dose.|Baseline up to Week 144|Safety analysis set; n = number of participants evaluable for adverse events. Abbreviations: HBV = hepatitis B virus, HBC = hepatitis C virus.||percentage of participants|||Number
734675|NCT00426660|Primary|Percentage of Participants With Treatment-emergent Adverse Events (AEs) by Age|Treatment-emergent AEs by age that occurred up to 30 days after the last dose of study medication.|Baseline up to Week 144|Safety analysis set; n = number of participants evaluable for adverse events.||percentage of participants|||Number
734676|NCT00426660|Primary|Percentage of Participants With Treatment-emergent Adverse Events (AEs) by Race|Treatment-emergent AEs by race that occurred up to 30 days after the last dose of study medication.|Baseline up to Week 144|Safety analysis set; n = number of participants evaluable for adverse events.||percentage of participants|||Number
734724|NCT00427661|Primary|Development of GVHD Within 1 Year of BMT|GVHD is assessed by physical exam, bloodwork and biopsy.|1 year|||participants|||Number
734678|NCT00426660|Primary|Percentage of Participants With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Time on Therapy||Baseline up to Week 144|Safety analysis set. Data not analyzed; the number of possible AIDS-related infections and malignancies and limited data collection during the study by time on therapy were such that a summary of AIDS-related infections by this parameter was not clinically meaningful.|||||
734679|NCT00426660|Primary|Percentage of Participants With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Baseline/Nadir CD4 Cell Counts||Baseline up to Week 144|Safety analysis set. Data not analyzed; the number of possible AIDS-related infections and malignancies and limited data collection during the study in terms of baseline/nadir CD4 cell counts were such that a summary of AIDS-related infections by this parameter was not clinically meaningful.|||||
734680|NCT00426660|Primary|Percentage of Participants With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Baseline Viral Load||Baseline up to Week 144|Safety analysis set. Data not analyzed; the number of possible AIDS-related infections and malignancies and limited data collection during the study in terms of baseline viral load were such that a summary of AIDS-related infections by this parameter was not clinically meaningful.|||||
734681|NCT00426660|Primary|Percentage of Participants With Acquired Immunodeficiency Syndrome (AIDS)-Defining Illnesses|Treatment-emergent AIDS-defining opportunistic illnesses based on investigator classification guided by a predefined list of clinical Category C adverse events per Center for Disease Control (CDC) HIV Classification System. Includes events occurring up to 30 days after last dose of study drug.|Baseline up to Week 144|Safety analysis set.||percentage of participants|||Number
734682|NCT00426660|Primary|Percentage of Participants With Grade 4 Laboratory Abnormalities Without Regards to Baseline Abnormalities|Laboratory abnormalities as defined by the Division of AIDS (DAIDS) toxicity grading scale: Grade 4, Very Severe = events which were unacceptable and intolerable or were irreversible or caused the participant to be in imminent danger of death.|Baseline up to Week 144|Safety analysis set. N = number of participants evaluable for laboratory abnormalities (with at least one observation of a laboratory test while on study treatment or during lag time); n = number of participants with at least one observation of given laboratory test while on study treatment or during lag time.||percentage of participants|||Number
734683|NCT00426660|Primary|Percentage of Participants With Grade 3 Laboratory Abnormalities Without Regards to Baseline Abnormalities|Laboratory abnormalities as defined by the Division of AIDS (DAIDS) toxicity grading scale: Grade 3, Severe =events that interrupted participants usual daily activity and traditionally required systemic drug therapy or other treatment.|Baseline up to Week 144|Safety analysis set. N = number of participants evaluable for laboratory abnormalities (with at least one observation of a laboratory test while on study treatment or during lag time); n = number of participants with at least one observation of given laboratory test while on study treatment or during lag time.||percentage of participants|||Number
734684|NCT00426660|Primary|Percentage of Participants With Grade 3 and Grade 4 Adverse Events (AE)|AEs as defined by the Division of AIDS (DAIDS) toxicity grading scale: Grade 3 = severe: interrupted usual daily activity and traditionally required systemic drug therapy or other treatment. Grade 4 = very severe: events that were unacceptable and intolerable or were irreversable or caused imminent danger of death. If same participant had more than 1 occurrence in the same preferred term event category, only the most severe (grade 4) occurrence was taken. Treatment-related = investigator assessment of a reasonable possibility that the investigational product caused or contributed to the AE.|Baseline up to Week 144|Safety analysis set: all participants who were randomized and received at least one dose of study medication.||percentage of participants|||Number
734685|NCT00426751|Secondary|Mean Duration of Stay in the Ward|Costs were measured as the duration of stay in the ward (outpatient, normal ward, and intensive care unit) within the specified timeframe was measured.|until 6 months after index-MI|ITT Population||days||Standard Deviation|Mean
734686|NCT00426751|Secondary|Number of Participants With Minor Bleedings (TIMI Classification)|The number of participants with minor bleedings (according to TIMI classification: clinically overt bleeding [e.g., gross haematuria or haematemesis) associated with a drop in haematocrit of ≥ 9% or a drop in haemoglobin of ≥ 3 g/dL) within the specified timeframe was measured.|Day 7 or hospital discharge; Day 30 after index-MI|Safety Population||participants|||Number
734687|NCT00426751|Secondary|Number of Participants With Major Bleedings (TIMI Classification)|Number of participants with major bleedings (according to TIMI classification: intracranial haemorrhage, spontaneous bleeding, bleeding at any instrumented site, retroperitoneal bleeding, or clinically significant overt haemorrhage associated with a drop in haematocrit of ≥ 15% or a drop in haemoglobin of ≥ 5 g/dL) within the specified timeframe was measured.|Day 7 or hospital discharge; Day 30 after index-MI|Safety Population||participants|||Number
734688|NCT00426751|Secondary|Number of Participants With Heart Failure Until 6 Months After PCI|The number of participants with heart failure within 6 month after PCI was measured.|until 6 Months (Day 180) after index-MI|Safety Population||participants|||Number
734689|NCT00426751|Secondary|Number of Participants Who Died and or Experienced Re-MI Until 6 Months After PCI|The number of participants who died and/or experienced re-MI within 6 month after PCI was measured.|until 6 Month (Day 180) after index-MI|Safety Population||participants|||Number
734690|NCT00426751|Secondary|Number of Participants Who Experienced Stroke or Major Bleeding Complications|Number of participants who experienced stroke (hemorrhagic, non-hemorrhagic) or major bleedings (TIMI class: intracranial haemorrhage, spontaneous bleeding, bleeding at any instrumented site, retroperitoneal bleeding, or clinically significant overt haemorrhage associated with a drop in haematocrit of ≥ 15% or a drop in haemoglobin of ≥ 5 g/dL).|Day 7 or hospital discharge; Day 30 after index-MI|Safety Population||participants|||Number
734691|NCT00426751|Secondary|Number of Participants Who Died, and/or Experienced Re-MI and UTVR (Individually Counted)|The number of participants who died, and/or experienced re-MI or UTVR (individually counted) within the specified timeframe was measured.|Day 7 or hospital discharge; Day 30 after index-MI|Safety Population||participants|||Number
734725|NCT00427700|Secondary|Serum Levels of Progesterone|The level of serum progesterone that indicated ovulation was considered to be 3 ng/mL or greater, on days 8 to 10 after ovulation.|8-10 days after ovulation|Intention to treat.Cases that were lost to follow-up observation, dropped out of the study, failed to collect progesterone on days 22 to 24, and lacked menses after medroxyprogesterone acetate treatment were considered as failures according to the intention-to-treat analysis.||ng/mL||95% Confidence Interval|Mean
734692|NCT00426751|Secondary|Combined Endpoint: Number of Participants With Events of Death, Re-myocardial Infarction (MI), and Urgent Target Vessel Revascularisation (UTVR)|The number of participants who died, experienced re-MI, or experienced UTVR (necessity of re-PCI of the target vessel or coronary artery bypass graft [CABG] because of recurrent ischaemic angina within 30 days after PCI) within the specified timeframe was measured.|Day 7 or hospital discharge; Day 30 after index-MI|Safety Population: All participants who received at least one dose of study medication.||participants|||Number
734693|NCT00426751|Secondary|Number of Participants With the Indicated Myocardial Blush Grade (TIMI Myocardial Perfusion Grade [TMPG]) After PCI|The number of participants with the indicated myocardial blush grade (TMPG), used to assess the myocardial reperfusion in the infarcted myocardium following PCI (as assessed by the core angiography laboratory), was measured. Blush grades: 0 = failure of dye to enter the microvasculature; 1 = dye slowly enters but fails to exit the microvasculature; 2 = delayed entry and exit of dye from the microvasculature; 3: normal entry and exit of dye from the microvasculature. Blush that is of only mild intensity throughout the washout phase but fades minimally is also classified as grade 3.|after PCI|ITT Population||participants|||Number
734694|NCT00426751|Secondary|Mean Number of Corrected TIMI Frame Counts (cTIMI) Following PCI|cTIMI frame counts (number of cineframes needed for dye to reach standardized distal landmarks in a coronary vessel; objective index of coronary blood flow) following PCI, as assessed by core angiography lab.|after PCI|ITT Population. Participants with un-evaluable angiographies were excluded from analysis.||number of frame counts||Standard Deviation|Mean
734695|NCT00426751|Secondary|Number of Participants With TIMI 3 Patency of Infarcted Vessels Following PCI|The number of participants with TIMI grade 3 (complete perfusion) patency of the infarcted vessels following PCI, as assessed by core angiography lab, was measured.|after PCI|ITT Population||participants|||Number
734696|NCT00426751|Secondary|Number of Participants With the Indicated Patency of Infarcted Vessels According to Thrombolysis in Myocardial Infarction (TIMI) Classification Before PCI|Number of participants with the respective patency of the infarcted vessels was evaluated by TIMI (Thrombolysis In Myocardial Infarction) flow grades (Grade 0 = No perfusion, Grade 1 = Penetration with minimal perfusion, Grade 2 = Partial perfusion, Grade 3 = Complete perfusion), as assessed by core angiography lab.|immediately before PCI|ITT Population||participants|||Number
734697|NCT00426751|Secondary|Mean Maximum ST Deviation Existing (Max STE) 60 Min After PCI|Max STE is measured similarly to single-lead STR, but was not compared with the ST deviation on the baseline ECG I. It was the existing ST deviation on the single ECG lead of maximum ST deviation present at 60 minutes after the PCI (ECG III).|60 min +/- 15 min after PCI (ECG III)|ITT Population. Participants with unevaluable ECGs were excluded from analysis.||millimeters (mm)||Standard Deviation|Mean
734698|NCT00426751|Secondary|Mean Change From Baseline in the Sum ST Resolution (STR) Before PCI|Mean sum STR was calculated as the difference between baseline (ECGI) and ECG II: the mean of the sum of ST elevation resolution from all ECG leads associated with infarct location. ST resolution was expressed as a percentage from baseline.|Baseline (ECG I) and immediately prior to PCI (ECG II)|ITT Population. Participants who did not have an ECG II immediately before PCI were excluded from analysis.||percent change||Standard Deviation|Mean
734699|NCT00426751|Secondary|Mean Change From Baseline in Single Lead ST Resolution (STR) 60 Min After PCI|Single lead STR is calculated as the difference between baseline (ECG I) and ECG III of either the ST elevation on one of the leads (II, III, aVF, V5, and V6) or the ST depression of one of the precordial leads (V1 -V4), whichever lead showed the largest deviation either at baseline or at follow-up, respectively. STR was expressed as a percentage from baseline.|Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)|ITT Population. Participants with unevaluable ECGs were excluded from analysis.||percent change||Standard Deviation|Mean
734700|NCT00426751|Secondary|Mean Change From Baseline in the Sum ST Resolution 60 Min After PCI|Sum STR was calculated as the difference between baseline (ECGI) and ECG III. The sum STR is the segment elevation resolution from all ECG leads associated with infarct location. ST resolution, a method used to evaluate myocardial reperfusion, was expressed as a percentage of the baseline.|Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)|ITT Population. Some participants were un-evaluable with regard to the primary endpoint and were counted as failures. These participants were excluded from this analysis.||percent change||Standard Deviation|Mean
734701|NCT00426751|Secondary|Number of Participants With Complete Single Lead ST Resolution (STR) 60 Min After PCI|Single lead STR is calculated as the difference (as a percentage) between baseline (ECG I) and ECG III of either the ST elevation on one of the leads (II, III, aVF, V5, and V6) or the ST depression of one of the precordial leads (V1- V4), whichever lead showed the largest deviation either at baseline or at ECG III, respectively (Complete: ≥ 70%; Partial: ≥ 30% and <70%).|Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)|ITT Population||participants|||Number
734702|NCT00426751|Secondary|Number of Participants With Complete or Partial Sum ST Resolution (STR) 60 Min After PCI|Sum STR was calculated as the difference between baseline (ECGI) and ECG III. The sum STR is the segment elevation resolution from all ECG leads associated with infarct location. ST resolution, a method used to evaluate myocardial reperfusion, was expressed as a percentage of the baseline (Complete: ≥ 70% resolution; Partial: ≥ 30% and < 70% resolution; None: < 30% resolution).|Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)|ITT Population||participants|||Number
734703|NCT00426751|Primary|Number of Participants With Complete Sum ST Resolution (STR) 60 Min After Percutaneous Coronary Intervention (PCI) (Intent-to-Treat Population)|Sum STR was calculated as the difference between baseline (ECG I) and ECG III. The sum STR is the segment elevation resolution from all ECG leads associated with the infarct location. ST resolution, a method used to evaluate myocardial reperfusion, was expressed as a percentage of the baseline value (Complete: ≥ 70% resolution).|Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)|Intent-to-Treat (ITT) Population: All randomized participants who received at least one dose of study medication.||participants|||Number
734726|NCT00427700|Primary|Percentage of Participants With Ovulation Detected by Ultrasound|Ovulation detected by ultrasound was defined as the percentage of a participants with ovulation detected by ultrasound, defined as the dominant follicle and its subsequent collapse. If a dominant follicle was not observed by day 21 after menses, the ovulation induction was considered to be a failure.|cycle day 14-20|intention to treat.||percentage of participants||95% Confidence Interval|Number
734704|NCT00426751|Primary|Number of Participants With Complete Sum ST Resolution (STR) 60 Minutes (Min) After Percutaneous Coronary Intervention (PCI) (Per Protocol Population)|Sum STR was calculated as the difference between baseline (ECG I) and ECG III. The sum STR is the segment elevation resolution from all ECG leads associated with the infarct location. ST resolution, a method used to evaluate myocardial reperfusion, was expressed as a percentage of the baseline value (Complete: ≥ 70% resolution).|Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)|Per Protocol (PP) Population: All randomized participants who received at least one dose of study drug, who had data that were fully evaluable for the primary endpoint, and who did not show any major protocol violation.||participants|||Number
734705|NCT00427336|Primary|Number of Patients With Engraftment Response|Engraftment defined as (1) the first of three consecutive days of an Absolute neutrophil count (ANC) >500/mL (b) the first of seven consecutive days of an unsupported platelet count 20,000. Patient needs to survive at least 28 days to be evaluable for engraftment. Chimerism studies need to demonstrate donor-derived hematopoiesis (>90%)|First 100 days post transplant.|||Participants|||Number
734706|NCT00427349|Secondary|Objective Response Rate|Tumor response was evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. Objective response rate is defined as number of patients with complete response (CR) or partial response (PR) divided by the total number of analyzable patients. CR is defined as complete disappearance of all tumor lesions, and partial response is defined as at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter.|assessed every 8 weeks while on treatment, and frequency of tumor measurements during follow-up were determined by the treating physician, assessed up to 5 years|||percentage of participants||90% Confidence Interval|Number
734707|NCT00427349|Secondary|Overall Survival|Overall survival (OS) is defined as the time from registration until death (event), or censored at last date known alive. OS was estimated using the Kaplan-Meier method , with 95% confidence intervals calculated using Greenwood’s formula|assessed every 3 months if patient is < 2 years from study entry, then every 6 months up to 5 years|All eligible and treated patients||months||95% Confidence Interval|Median
734708|NCT00427349|Primary|Four-month Progression-free Survival Rate|Four-month progression-free survival (PFS) rate is defined as number of patients who are still progression free at 4 months after study entry divided by number of eligible and treated patients enrolled to the study. Progression is evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s), or unequivocal progression of existing non-target lesions.|assessed every 4 weeks while on treatment and at three months post-treatment for participants treated for one cycle, up to month four|The analysis population includes all 44 eligible and treated patients. But 2 patients did not have disease assessment after study entry and are excluded from the analysis.||percentage of participants||90% Confidence Interval|Number
734709|NCT00427557|Primary|Number of Participants With Engraftment|Engraftment defined as first of three (3) consecutive days with Absolute neutrophil count (ANC) equal to or more than 0.5 * 10^9/L; assessed from baseline to 100 days post-engraftment.|Baseline to 100 days post-engraftment|Analysis per protocol.||participants|||Number
734710|NCT00427635|Secondary|Change From Baseline in Percentage Time With pH Within 4.0-6.9|Percentage time with pH 4.0-6.9 during 24-hour pH monitoring|Baseline and end of treatment (10-14 days)|||Percentage||Standard Deviation|Mean
734711|NCT00427635|Secondary|Change From Baseline in Percentage Time With pH<4.0|Percentage time with pH<4 during 24-hour pH monitoring|Baseline and end of treatment (10-14 days)|||Percentage||Standard Deviation|Mean
734712|NCT00427635|Secondary|Change From Baseline in Mean Acid Clearance Time|Based on 24-hour impedance monitoring data|Baseline and end of treatment (10-14 days)|||Seconds||Standard Deviation|Mean
734713|NCT00427635|Secondary|Change From Baseline in Mean Bolus Clearance Time|Based on 24-hour impedance monitoring data|Baseline and end of treatment (10-14 days)|||Seconds||Standard Deviation|Mean
734714|NCT00427635|Secondary|Change From Baseline in Number of Mixed Gas/Liquid Acidic Reflux Episodes|Number of reflux episodes based on 24-hour impedance monitoring data|Baseline and end of treatment (10-14 days)|||Mean Number of Episodes||Standard Deviation|Mean
734715|NCT00427635|Secondary|Change From Baseline in Number of Liquid Acidic Reflux Episodes|Number of reflux episodes based on 24-hour impedance monitoring data|Baseline and end of treatment (10-14 days)|||Mean Number of Episodes||Standard Deviation|Mean
734716|NCT00427635|Secondary|Change From Baseline in Number of Non Acidic Reflux Episodes|Number of reflux episodes (pH>=7.0) based on 24-hour impedance monitoring data|Baseline and end of treatment (10-14 days)|||Mean Number of Episodes||Standard Deviation|Mean
734717|NCT00427635|Secondary|Change From Baseline in Number of Weakly Acidic Reflux Episodes|Number of reflux episodes (pH 4.0-6.9) based on 24-hour impedance monitoring data|Baseline and end of treatment (10-14 days)|||Mean Number of Episodes||Standard Deviation|Mean
734718|NCT00427635|Secondary|Change From Baseline in Number of Acidic Reflux Episodes|Number of reflux episodes (pH<4.0) based on 24-hour impedance monitoring data|Baseline and end of treatment (10-14 days)|||Mean Number of Episodes||Standard Deviation|Mean
734719|NCT00427635|Secondary|Change From Baseline in Number of Reflux Episodes (Acid or Non-acid)|Number of reflux episodes based on 24-hour impedance monitoring data|Baseline and end of treatment (10-14 days)|||Mean Number of Episodes||Standard Deviation|Mean
734720|NCT00427635|Secondary|Change From Baseline in Normalized Number of GERD Events During Video and Cardiorespiratory Monitoring Associated With Acid Reflux|Event considered associated with reflux if start time of GERD sign/symptom is within 2 minutes of start time of acid reflux. The number of events are normalized prior to summary to correspond to a complete 8-hour monitoring period. Only patients with data at both baseline and final assessment are included.|Baseline and end of treatment (10-14 days)|||Mean Number of Events||Standard Deviation|Mean
734721|NCT00427635|Primary|Change From Baseline in Normalized Number of GERD Events Observed From Video and Cardiorespiratory Monitoring|The number of events are normalized prior to summary to correspond to a complete 8-hour monitoring period. Only patients with data at both baseline and final assessment are included.|Baseline and end of treatment (10-14 days)|||Mean Number of Events||Standard Deviation|Mean
734722|NCT00427661|Secondary|Incidence of Grade 2-4 Acute GVHD.||100 days|||participants with grade 2-4 AGVHD|||Number
734723|NCT00427661|Primary|Engraftment at 1 Year Post BMT.|Measurement of total PBMC chimerism|1 year|||participants|||Number
734727|NCT00427765|Primary|Average Overall Survival Time|Average number of years for survival post transplant where overall survival time is measured from date of transplant to disease progression or death for any reason.|Baseline(transplantation) to disease progression or death for any reason, up to 6 years.|Analysis by protocol||years||Full Range|Mean
734728|NCT00427778|Secondary|Post Void Residual|Post void residual measured by catheter after free flow uroflowmetry|"The UDS while wearing the ring was done 2-4 weeks into the 'ring' treatment period, at patient's convenience, the UDS done at baseline was considered representative of no treatment UDS."|All uroflow were obtained on arrival of the patient in the UDS suite and prior to instrumentation. patients were asked to arrive with a full bladder, but some did not, explaining the lower number of women with available results.||ml||Standard Deviation|Mean
734729|NCT00427778|Secondary|Patient Acceptability (10 cm VAS)|participants completed a 10 cm visual analogue scale at the end of 4 weeks of ring use, rating their pelvic discomfort on a 10 cm scale; 0= none, 10= max.|4 weeks|Women did not fill out this VAS when not wearing the incontinence ring.||cm||Standard Deviation|Mean
734730|NCT00427778|Secondary|Impact on I-QOL|The I-QOL (Incontinence-Quality of Life) is a valid and reproducible self-administered measure for assessing quality of life of patients with urinary incontinence. Items are scored on a 4-point Likert response scale (very much, moderately, a little, not at all). Scoring the I-QOL questionnaire involves summing the responses into a single score. The sum score is transformed to a 0-100 scale, with a higher number representing a better quality of life|4 weeks|||units on a scale||Inter-Quartile Range|Median
734731|NCT00427778|Secondary|Urodynamic Effect of the Incontinence Ring on Flow Rate|Peak flow rate (ml/sec) during uninstrumented uroflow. The 'no treatment' flow rate was obtained during baseline urodynamic studies (UDS) and the 'incontinence ring' flow rate was obtained at the end of the ring period for each participants, while wearing the ring.|baseline and at 4 weeks of ring use.|||ml/sec||Standard Deviation|Mean
734732|NCT00427778|Secondary|Objective Cure Rate|Number of Participants Without Urinary Stress Incontinence During Provocation testing during urodynamic studies (UDS). Provocations included valsalva and cough, first at 300 ml while lying then standing, followed, if no leakage was seen, to provocations at maximum cystometric capacity while standing.|4 weeks|||Participants|||Count of Participants
734733|NCT00427778|Secondary|UDI Overall Score|Urogenital Distress inventory - short form. The UDI is a 6-question validated questionnaire assessing the urinary tract symptoms and their bothersomeness. Answers are scored from 0-3 (3 most bothersome). An average score is then obtained, ranging from 0-3.|4 weeks|||units on a scale||Inter-Quartile Range|Median
734734|NCT00427778|Secondary|Score on Question 3 of UDI 6|"Score (0-3) of response to question #3 (stress incontinence specific) of Urogenital Distress inventory - short form. The UDI is a 6-question validated questionnaire assessing the urinary tract symptoms and their bothersomeness. Question three asks specifically about Leakage related to activity, coughing, or sneezing, i.e. stress urinary incontinence. Answer is scored from 0-3 (3 most bothersome)."|4 weeks|||units on a scale||Inter-Quartile Range|Median
734735|NCT00427778|Primary|Number of Participants With 50% or More Reduction in Number of Incontinence Episode Per Week|number of women who experienced 50% or more reduction in number of incontinence episode per week on diary while using the incontinence ring, compared to baseline period.|baseline and 4 weeks|All participants who were randomized and fitted with a ring are included in this intent to treat analysis. Patients for whom a ring could not be successfully fitted were considered failure (<50%) improvement)||Participants|||Count of Participants
734736|NCT00427791|Secondary|Number of Participants With Incidence of Acute Graft Versus Host Disease During First 100 Days|Number of participants with incidence of acute graft versus host disease (aGVHD) during first 100 days following transplant.|During the first 100 days following transplant|Analysis was by protocol.||participants|||Number
734737|NCT00427791|Primary|Progression-free Survival (PFS)|Time from randomization to first progression or death, whichever comes first, measured in months.|2 Years post transplant or until disease progression or death|Analysis was by protocol. Participants were randomized between Etoposide + Total body irradiation and Etoposide + Total body irradiation + Rituximab using a Bayesian adaptive algorithm.||Months||Standard Deviation|Median
734738|NCT00427804|Primary|Fractional Absorption of Calcium|Fractional absorption of calcium (see citation for complete details)|7 week|||Percentage of absorption|||Number
734739|NCT00427804|Primary|Intestinal Absorption of Calcium||12 Weeks||||||
734740|NCT00427895|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2|Systemic events reported using an electronic diary. Systemic events are any fever >=38 degrees C, fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized muscle pain, aggravated generalized muscle pain , new generalized joint pain), and aggravated generalized joint pain.|Within 14 days after vaccination 2|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants with known values for any systemic events. 'n'=number of participants with known values for specified systemic events for each group respectively. Participants may be represented in more than 1 category.||Percentage of participants||95% Confidence Interval|Number
734741|NCT00427895|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1|Systemic events reported using an electronic diary. Systemic events are any fever greater than or equal to (>=) 38 degrees Celsius [C], fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized (gen) muscle pain, aggravated generalized muscle pain , new generalized joint pain), and aggravated generalized joint pain. All reports of fever >40 degrees C in 13vPnC and 23vPS for Cohort 1 were confirmed as data entry errors.|Within 14 days after vaccination 1|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed )=participants with known values for any systemic events. 'n'=number of participants with known values for specified systemic events for each group respectively. Participants may be represented in more than 1 category.||Percentage of participants||95% Confidence Interval|Number
734808|NCT00427973|Secondary|Response Rate|"Number of patients who achieve either complete or partial response based on RECIST Criteria for target lesions assessed by MRI.
Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR"|Up to 1 year|Patients receiving AZD2171 (cediranib maleate)||participants with confirmed response|||Number
734742|NCT00427895|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2|Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 cm; Moderate (5.1 to 10.0 cm); Severe (>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating); Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).|Within 14 days after vaccination 2|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants with known values for any local reaction. 'n'=number of participants with known values for specified local reaction for each group respectively. Participants may be represented in more than 1 category.||Percentage of participants||95% Confidence Interval|Number
734743|NCT00427895|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1|Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters [cm]; Moderate (5.1 to 10.0 cm); Severe (>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating); Limitation of arm movement scaled as Any (limitation [lim] present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).|Within 14 days after vaccination 1|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed )=participants with known values for any local reaction. 'n'=number of participants with known values for specified local reaction for each group respectively. Participants may be represented in more than 1 category.||Percentage of participants||95% Confidence Interval|Number
734744|NCT00427895|Secondary|Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination|Antibody geometric mean concentration (GMC) as measured by microgram/milliliter (mcg/mL) for 12 common pneumococcal serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.|One month after vaccination 1 and One month after vaccination 2/Year 3 to 4|Evaluable immunogenicity population; n= number of participants with a determinate IgG concentration to the given serotype.||mcg/mL||95% Confidence Interval|Geometric Mean
734745|NCT00427895|Secondary|Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2|Geometric mean fold rises (GMFRs) for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results. CI for the GMFRs are back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.|Prevaccination 1 to 1 month after vaccination 2/Year 3 to 4|Evaluable immunogenicity population; n= number of participants with valid and determinate assay results for the specified serotype at both sampling times.||Fold Rise||95% Confidence Interval|Geometric Mean
734746|NCT00427895|Secondary|Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1|Percentage of participants achieving OPA GMTs with at least LLOQ for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) determined in blood samples of all participants using mcOPA assay. Exact 2-sided CI based on observed proportion of participants. LLOQ for each serotype: 1=1:18, 3=1:12, 4=1:21, 5=1:29, 6A=1:37, 6B=1:43, 7F=1:210, 9V=1:345, 14=1:35, 18C=1:31, 19A=1:18, 19F=1:48, 23F=1:13.|One month after vaccination 1|Evaluable immunogenicity population:eligible participants, received vaccination to which randomized, blood drawn within required timeframes, at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, no major protocol violations. n= number of participants with determinate OPA antibody titer to given serotype.||Percentage of participants||95% Confidence Interval|Number
734747|NCT00427895|Primary|Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS Group and 23vPS/23vPS Group|Serotype-specific OPA GMTs for the 12 pneumococcal common serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using mcOPA assay. CIs for GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|One month after vaccination 1 and One month after vaccination 2/Year 3 to 4|Evaluable immunogenicity population:eligible participants, received vaccination to which randomized, blood drawn within required timeframes, at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, no major protocol violations. n= number of participants with determinate OPA antibody titer to given serotype.||titers||95% Confidence Interval|Geometric Mean
734748|NCT00427895|Primary|Percentage of Participants Achieving At Least a 4-fold Rise in OPA Titer for Serotype 6A 1 Month After Vaccination 1 in Cohort 1|For serotype 6A the percentage of participants achieving at least a 4-fold rise on the serotype-specific antibody titer from pre-vaccination to 1 month post-vaccination was computed along with exact, 2-sided 95% confidence interval for the proportion.|One month after vaccination 1|Evaluable immunogenicity population; N (number of participants analyzed) signifies participants with determinate OPA antibody titer to serotype 6A.||percentage of participants||95% Confidence Interval|Number
734749|NCT00427895|Primary|Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1|Serotype-specific OPA GMTs for the 13 pneumococcal common serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using microcolony OPA (mcOPA) assay. CIs for GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|One month after vaccination 1|Evaluable immunogenicity population:eligible participants, received vaccination to which randomized, blood drawn within required timeframes, at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, no major protocol violations. n= number of participants with determinate OPA antibody titer to given serotype.||titer||95% Confidence Interval|Geometric Mean
734750|NCT00427921|Secondary|Work Productivity and Activity Impairment - Change From Baseline in Activity Impairment|The Work Productivity and Activity Impairment (WPAI) questionnaire is a validated, self-administered tool used to assess the impact of disease on productivity. There are four component scores for WPAI: absenteeism, presenteeism, total work productivity impairment, daily activity impairment. The score for each component ranges from 0% to 100% (0%=no impairment; 100%=total loss of work productivity or activity). The minimal clinically important difference (MCID) is an absolute change of 7%.|Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value)|In addition to the Intent To Treat population, summaries for outcome measures were provided for the analyzable subsets, and subjects in the Per-Protocol analysis set.||Units on scale||Standard Deviation|Mean
734751|NCT00427921|Secondary|Work Productivity and Activity Impairment - Change From Baseline in Presenteeism|The Work Productivity and Activity Impairment (WPAI) questionnaire is a validated, self-administered tool used to assess the impact of disease on productivity. There are four component scores for WPAI: absenteeism, presenteeism, total work productivity impairment, daily activity impairment. The score for each component ranges from 0% to 100% (0%=no impairment; 100%=total loss of work productivity or activity). The minimal clinically important difference (MCID) is an absolute change of 7%.|Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value)|In addition to the ITT population, summaries for outcome measures were provided for the analyzable subsets, and subjects in the Per-Protocol analysis set.||Units on scale||Standard Deviation|Mean
734752|NCT00427921|Secondary|Work Productivity and Activity Impairment - Change From Baseline in Absenteeism|The Work Productivity and Activity Impairment (WPAI) questionnaire is a validated, self-administered tool used to assess the impact of disease on productivity. There are four component scores for WPAI: absenteeism, presenteeism, total work productivity impairment, daily activity impairment. The score for each component ranges from 0% to 100% (0%=no impairment; 100%=total loss of work productivity or activity). The minimal clinically important difference (MCID) is an absolute change of 7%.|Weeks 4, 8, 12, and 24, and Last Assessmentl Value (last nonmissing value)|In addition to the Intent To Treat population, summaries for outcome measures were provided for the analyzable subsets, and subjects in the Per-Protocol analysis set.||units on a scale||Standard Deviation|Mean
734753|NCT00427921|Secondary|Urinalysis - Change From Baseline to Final Visit|Changes from the Group mean at baseline are compared to the final visit Group mean value|Up to 24 weeks|||number||Standard Deviation|Mean
734754|NCT00427921|Secondary|Clinical Chemistry - Change From Baseline to Final Visit|Changes from the Group mean at Baseline are compared to the final visit Group mean value|Up to 24 weeks|||number||Standard Deviation|Mean
734755|NCT00427921|Secondary|Hematology - Change From Baseline to Final Visit|Changes from the Group mean at baseline are compared to the final visit Group mean value|Up to 24 weeks|||number||Standard Deviation|Mean
734756|NCT00427921|Secondary|Work Productivity and Activity Impairment - Change From Baseline in Overall Work Impairment|"Scores are expressed as impairment percentages, higher numbers indicate greater impairment and less productivity (0% = no impairment; 100% = total loss of work productivity).
Minimal clinically important difference = 7 points. Measure is Mean percent change."|Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value)|In addition to the Intent To Treat population, summaries for outcome measures were provided for the analyzable subsets, and subjects in the Per-Protocol analysis set.||Units on scale||Standard Deviation|Mean
734757|NCT00427921|Secondary|50% Improvement in Draining Fistula Count and Fistula Healing|"Decrease in draining fistula is beneficial. 50 percent improvement refers to a reduction in the number of baseline fistula by 50 percent."|Week 12, Week 24, Last Assessment Value (last nonmissing value)|Intent To Treat||participants|||Number
734758|NCT00427921|Secondary|Employment Status: Number of Subjects Employed|Summary of employment status of those employed.|Baseline, Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value)|In addition to the Intent To Treat population, summaries for outcome measures were provided for the analyzable subsets, and subjects in the Per-Protocol analysis set.||participants|||Number
734759|NCT00427921|Secondary|Overall Health Care Resource Utilization|"From the Overall Health Care Resource Utilization Questionnaire: Number visits to physician, number visits to Emergency Room, number of hospital admissions, number of days of hospitalization."|Up to 24 weeks|In addition to the Intent To Treat population, summaries for outcome measures were provided for the analyzable subsets, and subjects in the Per-Protocol analysis set.||number of visits||Standard Deviation|Mean
734760|NCT00427921|Post-Hoc|Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Mean Change From Baseline|Quality of life questionnaire for patients with IBD consisting of 4 domains: systemic, social, emotional, and bowel. This is a 10-item questionnaire, and all items are reported with a 7-point scale (ranging from 1 = poor HRQOL, to 7 = optimum HRQOL). Total SIBDQ score ranges from 10 (quality of life has been negatively affected tremendously by IBD) to 70 (quality of life is barely impacted by IBD). A change greater than 9 points was the minimal clinically important difference (MCID).|Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value)|In addition to the Intent To Treat population, summaries for outcome measures were provided for the analyzable subsets, and subjects in the Per-Protocol analysis set.||units on a scale||Standard Deviation|Mean
734761|NCT00427921|Primary|Compliance With Number of Injections of Adalimumab. Compliance Corresponds to Patients Who Received Their Injections.|Treatment compliance (%) = 100 * (Number of doses of study medication actually received)/(Number of doses planned during the subject's participation in the study).|Up to 24 weeks|In addition to the Intent To Treat population, summaries for outcome measures were provided for the analyzable subsets, and subjects in the Per-Protocol analysis set.||Percentage of injections||Standard Deviation|Mean
734762|NCT00427921|Primary|Total Number of Injections of Adalimumab|Extent of exposure for all adalimumab treated subjects|Up to 24 weeks|In addition to the Intent To Treat population, summaries for outcome measures were provided for the analyzable subsets, and subjects in the Per-Protocol analysis set.||injections||Standard Deviation|Mean
734763|NCT00427921|Secondary|Fistula Count Mean Change From Baseline (Change in Number of Fistulas From Baseline).|Draining fistula counts is the sum of abdominal and perianal fistulas for each subject at each visit.|Week 12, Week 24, and Last Assessment Value (last nonmissing value)|||number of fistulas||Standard Deviation|Mean
734972|NCT00429364|Secondary|Annual Rate of Change in Body Mass Index||Up to 3 years following randomization.|All randomized participants whose body mass indexes were measured at baseline and at any of the follow-up visits.||kg/m^2 per year||Standard Error|Least Squares Mean
734764|NCT00427921|Post-Hoc|Harvey-Bradshaw Index (HBI) Mean Change From Baseline|HBI score (range 0-30) sum subtotal of 5 parameters of subject's CD activity: a)Well being 0=very well-4=terrible b) Abdominal pain 0=none- 3=severe c) Number liquid stools per day d) Abdominal mass 0=none-3=tender e) Complications: 1 point each. Decrease indicates improvement. Absolute decrease of 3 units on scale is clinically important.|Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value)|Intent to Treat - subjects who received at least one dose of study drug.||Units on scale||95% Confidence Interval|Mean
734765|NCT00427921|Primary|Mean Extent of Exposure - Duration in Days|Extent of exposure for all adalimumab treated subjects|Up to 24 weeks|In addition to the Intent To Treat population, summaries for outcome measures were provided for the analyzable subsets, and subjects in the Per-Protocol analysis set.||days||Standard Deviation|Mean
734766|NCT00427934|Secondary|Time for Cmax (Tmax) for MTX at Screening and Week 1 and Maraviroc at Week 1|PK was assessed at screening (MTX) and at Week 1 (maraviroc and MTX).|Screening (1, 2, 3, and 4 hours post-dose), Week 1 (0.5, 1, 2, 3, and 4 hours post-dose)|All available PK data from the Safety/PK Component were included.||hr||Full Range|Median
734767|NCT00427934|Secondary|Maximum Observed Concentration (Cmax) During the Dosing Interval for MTX at Screening and Week 1 and Maraviroc at Week 1|Effect of maraviroc on the PK of MTX (comparison of Cmax of MTX at screening versus at Week 1 after coadministration with 150 mg or 300 mg of maraviroc). PK was assessed at screening (MTX) and at Week 1 (maraviroc and MTX).|Screening (1, 2, 3, and 4 hours post-dose), Week 1 (0.5, 1, 2, 3, and 4 hours post-dose)|All available PK data from the Safety/PK Component were included.||ng/mL||Standard Deviation|Geometric Mean
734768|NCT00427934|Secondary|Area Under the Plasma Concentration-Time Profile From Time Zero to Four Hours Postdose (AUC 0-4) for MTX at Screening and Week 1 and Maraviroc at Week 1|Effect of maraviroc on the PK of MTX (comparison of AUC0-4 of MTX at screening versus at Week 1 after coadministration with 150 mg or 300 mg of maraviroc). PK was assessed at screening (MTX) and at Week 1 (maraviroc and MTX).|Screening (1, 2, 3, and 4 hours post-dose), Week 1 (0.5, 1, 2, 3, and 4 hours post-dose)|All available PK data from the Safety/PK Component were included.||ng.hr/mL||Standard Deviation|Geometric Mean
734769|NCT00427934|Secondary|Survival Analysis of Time to Withdrawal: Proportion of Subjects Who Did Not Withdraw From the Study Due to Lack of Efficacy.|Withdrawal due to lack of efficacy was collected based on the investigator’s judgement. Time to withdrawal was measured by the probability that a subject did not withdraw due to lack of efficacy by a particular visit. This was a statistical estimate (Kaplan-Meier Survival Analysis) of the probability that a participant would not withdraw due to lack of efficacy.|Weeks 1 to 12|FAS||proportion|||Number
734770|NCT00427934|Secondary|Number of Subjects With Withdrawal From Study Due to Lack of Efficacy|Withdrawal is the total number of withdrawals from the study. Withdrawal due to lack of efficacy was collected based on the investigator’s judgement.|16 weeks|FAS||participants|||Number
734771|NCT00427934|Secondary|Change From Baseline in SF-36 Mental Component Summary at Weeks 4 and 12|The SF-36 v.2 (Acute version) [12] is a 36-item generic health status measure that measures 8 general health concepts: Physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each domain of the eight domains and the summary concept (mental component score) are scored to yield values between 0 (worst) and 100 (best). Change from baseline at Weeks 4 and 12 were analyzed for SF-36. Due to the termination of the study, SF-36 results for the PK component group were not analyzed.|Baseline, Weeks 4 and 12|FAS||scores on a scale||Standard Error|Least Squares Mean
734772|NCT00427934|Secondary|Change From Baseline in Short Form-36 (SF-36) Physical Component Summary at Weeks 4 and 12|The SF-36 v.2 (Acute version) is a 36-item generic health status measure that measures 8 general health concepts: Physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each domain of the eight domains and the summary concept (physical component score) are scored to yield values between 0 (worst) and 100 (best). Change from baseline at Weeks 4 and 12 were analyzed for SF-36. Due to the termination of the study, SF-36 results for the PK component group were not analyzed.|Baseline, Weeks 4 and 12|FAS||scores on a scale||Standard Error|Least Squares Mean
734773|NCT00427934|Secondary|Number of Subjects With Categorical Absolute ECG Parameters and ECG Changes Compared to Baseline|Maximum QTcB, QTcF, and QTc intervals were defined as 450 to < 480 msec, 480 to < 500 msec, or > = 500 msec.|Baseline, 16 weeks|FAS||Participants|||Number
734774|NCT00427934|Secondary|Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (Heart Rate).|Baseline was defined to be the latest non-missing value from a range of pre-treatment visits. Means of replicate values were used.|Baseline, 16 weeks|FAS||bpm||Standard Deviation|Mean
734775|NCT00427934|Secondary|Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (RR Interval, PR Interval, QRS Complex, QT Interval, Corrected QT [QTc] Interval, QTcB Interval [Bazett's Correction], QTcF Interval [Fridericia's Correction]).|Baseline was defined to be the latest non-missing value from a range of pre-treatment visits. Means of replicate values were used. QTc interval was not measured for the PK populations.|Baseline, 16 weeks|FAS||msec||Standard Deviation|Mean
734776|NCT00427934|Secondary|Number of Subjects With Categorical Absolute Vital Signs and Vital Sign Changes Compared to Baseline|Baseline was defined to be the latest non-missing value from a range of pre-treatment visits. Maximum increase from baseline in supine and standing systolic BP was > = 30 mmHg, and maximum increase from baseline in supine and standing diastolic BP was > = 20 mmHg.|Baseline, 16 weeks|FAS||Participants|||Number
734777|NCT00427934|Secondary|Change From Baseline in Mean Heart Rate|Heart rate = standing and supine at the same time the orthostatic BP measurements were obtained. Baseline was defined to be the latest non-missing value from a range of pre-treatment visits. Means of replicate values were not used.|Baseline, 16 weeks|FAS||beats per minute (bpm)||Standard Deviation|Mean
734778|NCT00427934|Primary|American College of Rheumatology (ACR) 20% Responders at Week 12|A subject was an ACR 20 responder if: the counts for both tender and swollen joints had reduced by 20% or more from baseline; and 3 out of the following 5 assessments showed reduction of 20% or more from baseline assessment: Patient’s Assessment of Arthritis Pain (Visual Analogue Scale [VAS]), Patient’s Global Assessment of Arthritis (VAS), Physician’s Global Assessment of Arthritis (Categorical), Health Assessment Questionnaire – Disability Index (HAQ-DI), and C-Reactive Protein (CRP).|Week 12|Full Analysis Set (FAS) was defined as an intent-to-treat analysis set that included all subjects randomized to treatment who had taken at least 1 dose of study medication. Missing values were imputed by the method of last observation carried forward (LOCF).||Participants|||Number
734779|NCT00427934|Secondary|Change From Baseline in Mean Orthostatic Blood Pressure (BP)|Supine BP was recorded after 5 minutes lying down; subjects then sat for 2 minutes then stood for 2 minutes and standing BP was recorded. Orthostatic BP = either a systolic BP drop > 20 mmHg, or diastolic BP drop > 10 mmHg and/or drop in systolic BP < 90 mmHg. If a subject met the orthostatic criteria, they were required to complete 2 additional readings to provide a triplicate reading. The means of replicate BP values were used in the analysis. Baseline = the latest non-missing value from a range of pre-treatment visits. Change from baseline to Week 16 was analyzed for orthostatic BP.|Baseline, 16 weeks|FAS||mmHg||Standard Deviation|Mean
734780|NCT00427934|Secondary|Change From Baseline in Disease Activity Score Using CRP (DAS28-4[CRP]) at Weeks 1, 2, 4, 8, and 12|"DAS28-4 (CRP) was calculated using the following formula:
DAS28- 4(CRP) = 0.56 √28 Tender Joint Count + 0.28 √28 Swollen Joint Count + 0.36*natural logarithm(CRP + 1) + 0.014*Patient Global Assessment + 0.96. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity. Change from baseline at each visit was analyzed for DAS28-4 (CRP). The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 DAS28-4 (CRP) data were collected, but not analyzed."|Baseline, Weeks 1, 2, 4, 8, and 12|FAS. Missing values were imputed by the method of LOCF.||mg/L||Standard Error|Least Squares Mean
734781|NCT00427934|Secondary|Change From Baseline in CRP at Weeks 1, 2, 4, 8, and 12|Change from baseline at each visit were analyzed for CRP. The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 CRP data were collected, but not analyzed.|Baseline, Weeks 1, 2, 4, 8, and 12|FAS. Missing values were imputed by the method of LOCF.||mg/L||Standard Error|Least Squares Mean
734782|NCT00427934|Secondary|Change From Baseline in HAQ-DI at Weeks 1, 2, 4, 8, and 12|HAQ-DI assesses degree of difficulty experienced in daily activity categories (dressing/grooming, arising, eating, walking, hygiene, reach, grip and other activities) over the past week. There are 20 questions and difficulty is scored from 0 (none), 1 (some), 2 (much) and 3 (unable to do). Scores were then averaged to give the disability index (scale of 0 to 3). Change from baseline at each visit was analyzed. The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 HAQ-DI data were collected but not analyzed.|Baseline, Weeks 1, 2, 4, 8, and 12|FAS.||scores on scale||Standard Error|Least Squares Mean
734783|NCT00427934|Secondary|Change From Baseline in Physician's Global Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, and 12|Physician's evaluation based on subject’s disease signs, functional capacity and physical exam. Response recorded using 5-point scale: 1=Very Good, 2=Good, 3=Fair, 4=Poor and 5=Very Poor. Change from baseline at each visit was analyzed for Physician’s Global Assessment. The Week 16 visit (follow-up) was designed for safety rather than efficacy thus Week 16 Physician's Global Assessment of Arthritis Pain data were collected but not analyzed.|Baseline, Weeks 1, 2, 4, 8, and 12|FAS. Missing values were imputed by the method of LOCF.||scores on scale||Standard Error|Least Squares Mean
734784|NCT00427934|Secondary|Change From Baseline in Patient's Global Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, and 12|Subjects answered: “Considering all the ways your arthritis affects you, how are you feeling today?” Subjects responded by using a 0 - 100 mm VAS where 0=very well and 100=very poorly. Change from baseline at each visit was analyzed for Patient’s Global Assessment. The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 Patient's Global Assessment of Arthritis Pain data were collected, but not analyzed.|Baseline, Weeks 1, 2, 4, 8, and 12|FAS. Missing values were imputed by the method of LOCF.||scores on scale||Standard Error|Least Squares Mean
734785|NCT00427934|Secondary|Change From Baseline in Patient's Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, and 12|The severity of arthritis was scored by the subject between 0 (no pain) and 100 (most severe pain) on a 100 mm VAS. Change from baseline at each visit was analyzed for Patient’s Assessment of Arthritis Pain. The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 Patient's Assessment of Arthritis Pain data were collected, but not analyzed.|Baseline, Weeks 1, 2, 4, 8, and 12|FAS. Missing values were imputed by the method of LOCF.||scores on scale||Standard Error|Least Squares Mean
734786|NCT00427934|Secondary|Change From Baseline in Swollen Joint Count at Weeks 1, 2, 4, 8, and 12|Change from baseline at each visit was analyzed for swollen joint count. Twenty-eight tender and swollen joint scores included the same joints: shoulders, elbows, wrists, MCP joints, PIP joints, and the knees. The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 swollen joint count data were collected, but not analyzed.|Baseline, Weeks 1, 2, 4, 8, and 12|FAS. Missing values were imputed by the method of LOCF.||joint count||Standard Error|Least Squares Mean
734787|NCT00427934|Secondary|Change From Baseline in Tender/Painful Joint Count at Weeks 1, 2, 4, 8, and 12|Change from baseline at each visit was analyzed for tender/painful joint count. Twenty-eight tender and swollen joint scores included the same joints: shoulders, elbows, wrists, metacarpophalangeal joints (MCP), proximal interphalangeal joints (PIP), and the knees. The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 tender/painful joint count data were collected, but not analyzed.|Baseline, Weeks 1, 2, 4, 8, and 12|FAS. Missing values were imputed by the method of LOCF.||joint count||Standard Error|Least Squares Mean
734788|NCT00427934|Secondary|ACR 70% Responders at Weeks 1, 2, 4, 8, and 12|A subject was an ACR 70 responder if: the counts for both tender and swollen joints had reduced by 70% or more from baseline; and 3 out of the following 5 assessments showed reduction of 70% or more from baseline assessment: Patient’s Assessment of Arthritis Pain, Patient’s Global Assessment of Arthritis, Physician’s Global Assessment of Arthritis, HAQ-DI, and CRP. The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 ACR 70% data were collected, but not analyzed.|Weeks 1, 2, 4, 8, and 12|FAS. Missing values were imputed by the method of LOCF.||Participants|||Number
734789|NCT00427934|Secondary|ACR 50% Responders at Weeks 1, 2, 4, 8, and 12|A subject was an ACR 50 responder if: the counts for both tender and swollen joints had reduced by 50% or more from baseline; and 3 out of the following 5 assessments showed reduction of 50% or more from baseline assessment: Patient’s Assessment of Arthritis Pain, Patient’s Global Assessment of Arthritis, Physician’s Global Assessment of Arthritis, HAQ-DI, and CRP. The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 ACR 50% data were collected, but not analyzed.|Weeks 1, 2, 4, 8, and 12|FAS. Missing values were imputed by the method of LOCF.||Participants|||Number
735312|NCT00434356|Secondary|Adverse Events Leading to Death|All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0|30 days following the last administration of study treatment|Treated patients||participants|||Number
734790|NCT00427934|Secondary|ACR 20% Responders at Weeks 1, 2, 4, and 8|A subject was an ACR 20 responder if: the counts for both tender and swollen joints had reduced by 20% or more from baseline; and 3 out of the following 5 assessments showed reduction of 20% or more from baseline assessment: Patient’s Assessment of Arthritis Pain, Patient’s Global Assessment of Arthritis, Physician’s Global Assessment of Arthritis, HAQ-DI, and CRP. The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 ACR 20% data were collected, but not analyzed.|Weeks 1, 2, 4, and 8|FAS. Missing values were imputed by the method of LOCF.||Participants|||Number
734791|NCT00427960|Secondary|The Percentage of Participants Reaching the European (EAS) Targets of LDL-C<2.5 or 3.00 mmol/L, Depending on Risk Category.|"Risk categories are:
Symptomatic Asymptomatic, total risk <5% Asymptomatic, total risk ≥5%, baseline LDL-C<3 mmol/L and baseline TC<5 mmol/L Asymptomatic, total risk ≥5%, baseline LDL-C ≥3 mmol/L or baseline TC ≥5 mmol/L
Patients are defined as symptomatic if they meet at least 1 of the following criteria:
History of cardiovascular disease Type II diabetes or diabetes of unknown type Baseline TC ≥8 mmol/l Baseline LDL-C ≥6 mmol/l Baseline systolic BP ≥180 mmHg Baseline diastolic BP ≥110 mmHg
Total risk is derived from age, sex, TC, systolic BP and smoking status."|6 weeks (baseline) and 12 weeks|Intention to treat (ITT) population (all randomized patients).||Percentage of Participants|||Number
734792|NCT00427960|Secondary|The Percentage Change From Baseline (Week 6) in ApoB/ApoA1 Ratio|Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6|6 weeks (baseline) and 12 weeks|Intention to treat (ITT) population (all randomized patients).||Percent Change in ApoB/ApoA1 Ratio|||Number
734793|NCT00427960|Secondary|The Percentage Change From Baseline(Week 6) in Non-HDL-C/HDL-C Ratio|Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6|6 weeks (baseline) and 12 weeks|Intention to treat (ITT) population (all randomized patients).||Percent Change in Non-HDL-C/HDL-C Ratio|||Number
734794|NCT00427960|Secondary|The Percentage Change From Baseline (Week 6) in TC/HDL-C Ratio|Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6|6 weeks (baseline) and 12 weeks|Intention to treat (ITT) population (all randomized patients).||Percent Change in TC/HDL-C Ratio|||Number
734795|NCT00427960|Secondary|The Percentage Change From Baseline (Week 6)in LDL-C/HDL-C Ratio|Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6|6 weeks (baseline) and 12 weeks|Intention to treat (ITT) population (all randomized patients).||Percent Change in LDL-C/HDL-C Ratio|||Number
734796|NCT00427960|Secondary|The Percentage Change From Baseline (Week 6) in Apolipoprotein-A1 (ApoA1)|Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6|6 weeks (baseline) and 12 weeks|Intention to treat (ITT) population (all randomized patients).||Percent Change in ApoA1|||Number
734797|NCT00427960|Secondary|The Percentage Change From Baseline (Week 6) in Apolipoprotein-B (ApoB)|Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6|6 weeks (baseline) and 12 weeks|Intention to treat (ITT) population (all randomized patients).||Percent Change in ApoB|||Number
734798|NCT00427960|Secondary|The Percentage Change From Baseline (Week 6)in Non-HDL-C|Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6|6 weeks (baseline) and 12 weeks|Intention to treat (ITT) population (all randomized patients).||Percent Change in Non-HDL-C|||Number
734799|NCT00427960|Secondary|The Percentage of Participants Reaching the Joint British Societies Guideline (JBS 2) Target of TC <4 mmol/L||6 weeks (baseline) and 12 weeks|Intention to treat (ITT) population (all randomized patients).||Percentage of Participants|||Number
734800|NCT00427960|Secondary|The Percentage Change From Baseline (Week 6) in High-density Lipoprotein Cholesterol (HDL-C)|Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6|6 weeks (baseline) and 12 weeks|Intention to treat (ITT) population (all randomized patients).||Percent Change in HDL-C|||Number
734801|NCT00427960|Secondary|The Percentage Change From Baseline(week6) in TC|Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6|6 weeks (baseline) and 12 weeks|Intention to treat (ITT) population (all randomized patients).||Percent Change in TC|||Number
734802|NCT00427960|Secondary|The Percentage of Participants Reaching the European (EAS) Targets of LDL-C<2.5 or 3.00 mmol/L, Depending on Risk Category, and the Combined LDL-C and TC Target of LDL-C<2.5 or 3.0 mmol/L and TC<4.5 or 5.0 mmol/L, Both Depending on Risk Category.|"Risk categories are:
Symptomatic Asymptomatic, total risk <5% Asymptomatic, total risk ≥5%, baseline LDL-C<3 mmol/L and baseline TC<5 mmol/L Asymptomatic, total risk ≥5%, baseline LDL-C ≥3 mmol/L or baseline TC ≥5 mmol/L
Patients are defined as symptomatic if they meet at least 1 of the following criteria:
History of cardiovascular disease Type II diabetes or diabetes of unknown type Baseline TC ≥8 mmol/l Baseline LDL-C ≥6 mmol/l Baseline systolic BP ≥180 mmHg Baseline diastolic BP ≥110 mmHg
Total risk is derived from age, sex, TC, systolic BP and smoking status."|6 weeks (baseline) and 12 weeks|Intention to treat (ITT) population (all randomized patients).||Percentage of Participants|||Number
734803|NCT00427960|Secondary|The Percentage of Participants Reaching the Joint British Societies’ Guideline (JBS 2) Targets of TC <4 mmol/L and LDL-C <2 mmol/L||6 weeks (baseline) and 12 weeks|Intention to treat (ITT) population (all randomized patients).||Percentage of Participants|||Number
734804|NCT00427960|Secondary|The Percentage of Participants Reaching the General Medical Services (GMS) Contract Target of Total Cholesterol (TC) <5 mmol/L||6 weeks (Baseline) and 12 weeks|Intention to treat (ITT) population (all randomized patients).||Percentage of Participants|||Number
734805|NCT00427960|Primary|Percentage Change in Low Density Lipoprotein - Cholesterol (LDL-C)|Calculated as LDL-C at Week 6 - LDL-C at Week 12] * 100|6 weeks (baseline) and 12 weeks|Intention to treat (ITT) population (all randomized patients).||Percent Change in LDL-C|||Number
734806|NCT00427973|Post-Hoc|Discontinued Treatment Due to SAE|Participants that discontinued treatment due to a Serious Adverse Event (SAE)|May 2009 through January 2010|||Participants|||Number
734807|NCT00427973|Secondary|Overall Survival|Overall survival will be calculated using the Kaplan-Meier method, and confidence limits for survival estimates will be calculated using the Greenwood formula.|The time from study entry until death from any cause, assessed up to 1 year|||months||95% Confidence Interval|Median
734973|NCT00429364|Secondary|Annual Rate of Change in Height-for-age Z-score||Up to 3 years following randomization.|All randomized participants who were between 0-20 years of age and whose heights were measured at baseline and at any of the follow-up visits.||z-score/year||Standard Error|Least Squares Mean
734809|NCT00427973|Primary|Progression-free Survival|"Progression is defined as a 20% increase in the sum of the of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions by conventional RECIST based criteria, or death, which ever comes first.
This design yields at least 90% power to detect a true 3-month PFS rate of at least 69%."|3 months|The number of patients who were progression free at 3 months was determined. 13 of 17 patients (77%) were progression free at 3 months.||percentage of participants||95% Confidence Interval|Number
734810|NCT00427999|Secondary|Quality of Life Assessed With EORTC-30|Health-related quality of life was assessed with the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-30) questionnaire and was presented descriptively. The EORTC QLQ-C30 is a questionnaire including following sub-scales: global health status, functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social activity), symptom scales (fatigue, nausea and vomiting, and pain) and single items (dyspnoea, insomnia, appetite loss, constipation, diarrhoea and financial difficulties). Scores are averaged for each scale and transformed to 0-100 scale; higher score indicates better quality of life on global health status and functional scales and worse quality of life on symptom scales and financial difficulty scale.|baseline and Final Visit (week 24)|Intent to Treat (ITT) includes the 61 patients treated||scores on a scale||Standard Deviation|Mean
734811|NCT00427999|Secondary|Overall Survival Rate|Overall survival (OS) is defined as time from randomization to death from any cause or last date known alive. The median time to overall survival rate was not achieved|every 4 weeks up to 24 weeks|Intent to Treat (ITT) includes the 61 patients treated.||days||95% Confidence Interval|Median
734812|NCT00427999|Secondary|Time to Progression-free Survival|Progression-free survival, defined as the time from first administration of study drugs to the first PSA value of a PSA non-responder. Responders will be censored with date of PSA response for the analysis. The median time to PSA progression free survival was not achieved|every 4 weeks up to 24 weeks|Intent to Treat (ITT) includes the 61 patients treated.||days||95% Confidence Interval|Median
734813|NCT00427999|Secondary|Time to PSA Response|Time to PSA response, defined as the time from first administration of study drugs to the first PSA value of a confirmed PSA response. Non-responders will be censored with date of final visit/premature discontinuation for the analysis. Median time to PSA response was not achieved|every 4 weeks up to 24 weeks|Intent to Treat (ITT) includes the 61 patients treated.||days||95% Confidence Interval|Median
734814|NCT00427999|Primary|PSA Response Rate|To investigate the effect of a treatment with Imatinib mesylate, Pioglitazone , Etoricoxib, and Dexamethasone in combination with metronomic chemotherapy (Treosulfane) on the PSA response rate in patients with hormone refractory prostate cancer. A patient will be defined as a responder if a PSA decline of at least 50%, which must be confirmed by a second PSA value 4 weeks later, is observed. A patient will be defined as a non-responder if PSA has not decreased during treatment. Non-response is defined as a 25% increase over the baseline on-study which is confirmed (equal or more) by a second value 4 weeks apart. The absolute increase must account for > 5 ng/ml.|up to 24 weeks|Intent to Treat (ITT) includes the 61 patients treated.||participants|||Number
734815|NCT00428077|Secondary|Safety of a Vaccine Containing Native and Synthetic Chronic Myeloid Leukemia (CML) Peptides Over 1 Year Treatment.||Weeks 2, 4, 6, 9, and monthly thereafter up to 2 years.||||||
734816|NCT00428077|Primary|Correlation of Response With Specific HLA Types||12-24 Months||||||
734817|NCT00428077|Primary|Immunologic Response Over 1 Year||12 months||||||
734818|NCT00428077|Primary|Comparison of Response in Patients With B3A2 Junctions vs B2A2 Junctions||12-24 Months||||||
734819|NCT00428077|Primary|Percentage of Patients Who Become RT-PCR-negative for BCR-ABL Transcripts||12-24 Months||||||
734820|NCT00428077|Primary|Number of Participants With One-log Decrease in Circulation Breakpoint Cluster Region-Abelson Murine Leukemia(BCR-ABL) Transcripts That Persists for at Least Three Months During the 1-year Treatment Period.|One-log decrease in circulating BCR-ABL transcripts (RT-PCR) that persists for at least three months during the 1-year treatment period.|Every 3 months for the duration of the 1-year treatment period. .|Per protocol.||Participants|||Number
734821|NCT00428090|Secondary|Number of Par. With Clinical Chemistry Values of Potential Clinical Concern Any Time on Treatment|Clinical chemistry parameters were identified as of PCC (H, L), if values were out of RR: Alanine aminotransferase (ALT, none-120 [250% upper limit of RR, ULRR]), Albumin (0.75-2), Aspartate aminotransferase (AST,none-105 (3-64y), 137.5 (65+y), >250%ULRR), Alkaline phosphatase (ALP,none-312.5 (20+y), >250%ULRR), blood urea nitrogen (BUN)/Creatinine ratio (none-1.25), BUN (none-11), Chloride (80-115), Calcium (0.75-1.25), Carbon dioxide (CO2, 15-40) content, Creatinine (22, <50% lower limit of RR [LLRR]-155, >125%ULRR), Creatine phosphokinase (CPK, none-1.25), Gamma glutamyl transferase (GGT,none-2.5), Glucose (3.6-7.8), High density lipoprotein (HDL,0.65-none), Lactate dehydrogenase (LDH,none-1.25), Low density lipoprotein (LDL,none-2), Magnesium (0.5-2), Potassium (3-5.5), Phosphorus inorganic (0.5-1.5), Sodium (130-150), Total protein (0.8-1.5), Total cholesterol (none-1.25), Total bilirubin (none-1.95), Triglycerides (none-9). Data for Creatinine clearance not reported.|Up to W24|Safety Population. Only those par. available at the specified time points were analyzed (represented as n=x,x,x,x in the category titles).||Participants|||Number
734822|NCT00428090|Secondary|Number of Par. With Hematology Data of Potential Clinical Concern Any Time on Treatment|Haematology parameters were identified as of PCC (high [H], low [L]), if the values were out of the reference range (RR). The range for parameters was: platelet (100AV-500AV), red blood cell (RBC, 0.8-1.2), hemoglobin (L: female [F]:10, male [M]:11; H: F:16.5–AV, M:18), hematocrit (0.8-1.2), white blood cell (WBC, 3-15), neutrophils (0.75-1.5), lymphocytes (0.75-1.5), monocytes (0.75-2), eosinophils (none-2), basophils (none-2), mean corpuscle volume (MCV, 0.8-1.2), mean corpuscular hemoglobin (MCH, 0.8-1.2), mean corpuscular hemoglobin concentration (MCHC, 0.8-1.2), red cell distribution width (RDW, 0.8-1.2). Data for mean platelet volume (reference range not established) not reported|Up to W24|Safety Population. Only those par. available at the specified time points were analyzed (represented as n=x,x,x,x in the category titles).||Participants|||Number
734823|NCT00428090|Secondary|Change From Baseline (W0) in Periodic HbA1c Assessment|HbA1c assessment was performed par. with type 2 diabetes mellitus or HbA1c >=6.5% at Screening only. HbA1c levels were assessed at Baseline, W12 and W24. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0.|Baseline (W0) and up to W24|Safety Population. Only those par. available at the specified time points were analyzed (represented as n=x,x,x,x in the category titles).||Percentage||Standard Deviation|Mean
734824|NCT00428090|Secondary|Change From Baseline (W0) in Hematocrit|Hematology parameters were assessed at Baseline, W4, W12 and W24. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0.|Baseline (W0) and Up to W24|Safety Population. Only those par. available at the specified time points were analyzed (represented as n=x,x,x,x in the category titles).||Percentage of red blood cells in blood||Standard Deviation|Mean
734825|NCT00428090|Secondary|Change From Baseline (W0) in Hemoglobin|Hematology parameters were assessed at Baseline, W4, W12 and W24. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0.|Baseline (W0) and up to W24|Safety Population. Only those par. available at the specified time points were analyzed (represented as n=x,x,x,x in the category titles).||Grams per liter (G/L)||Standard Deviation|Mean
734826|NCT00428090|Secondary|Change From Baseline (W0) in Body Weight|Body weight will be measured at all visits, without shoes and wearing light clothing. The assessments was performed at Baseline, W4, W8, W12, W16, and W24. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0.|Baseline (W0) and up to W24|Safety Population. Only those par. available at the specified time points were analyzed (represented as n=x,x,x,x in the category titles).||Kilogram (Kg)||Standard Deviation|Mean
734827|NCT00428090|Secondary|Change From Baseline (W0) in Heart Rate (HR) Measured From 12-lead Electrocardiogram (ECG)|Triplicate 12-lead ECG measures was obtained digitally, approximately one minute apart after the par. had rested in the supine position in a quiet room (no TV, minimal talking) for at least 10 minutes. Conduction intervals from the 12-lead ECGs were manually read and confirmed by an external cardiologist/vendor. The ECG HR of Central Cardiologist reported. The assessments was performed at Baseline and W24. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at Screening/Visit 1/W-6.|Baseline (W0) and up to W24|Safety Population. Only those par. available at the specified time points were analyzed (represented as n=x,x,x,x in the category titles).||Beats per minute||Standard Deviation|Mean
734828|NCT00428090|Secondary|Change From Baseline (W0) in 12-lead Electrocardiogram (ECG)|Triplicate 12-lead ECG measures was obtained digitally, approximately one minute apart after the par. had rested in the supine position in a quiet room (no TV, minimal talking) for at least 10 minutes. Conduction intervals from the 12-lead ECGs were manually read and confirmed by an external cardiologist/vendor. The ECG parameters includes PR interval, QRS duration, QT – uncorrected interval, QTc Bazett (QTcB), QTc Fridericia (QTcF) and RR interval of Central Cardiologist are reported. The assessments was performed at Baseline and W24. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at Screening/Visit 1/W-6.|Baseline (W0) and up to W24|Safety Population. Only those par. available at the specified time points were analyzed (represented as n=x,x,x,x in the category titles).||milliseconds (MSEC)||Standard Deviation|Mean
734829|NCT00428090|Secondary|Number of Participants With Systolic and Diastolic Blood Pressure (SBP and DBP), Heart Rate (HR) and Weight Values of Potential Clinical Concern (PCC) Any Time on Treatment (ATOT).|SBP, DBP and HR of par. were recorded in sitting posture as vital signs, while body weight was measured without shoes and wearing light clothing at each visit. The blood pressure (BP) and HR values were identified as of PCC if the vales were out of the reference range (for SBP, 90 to 140 millimeters of mercury (mmHg), DBP, 50 to 90 mmHg, and HR >100 or <50 beats per minute [bpm]) or meet a change from Baseline criterion. For SBP it was increase from Baseline (high) if increased by more than or equal to (>=) 40 mmHg; decrease from Baseline (low) if decreased by >=30 mmHg. For DBP, increase from Baseline (high) if increased by >=30 mmHg; decrease from Baseline (low) if decreased by >=20 mmHg. For HR, increase from Baseline (high) if increased by >=30 bpm; decrease from Baseline (low) if decreased by >=30 bpm. For weight, increase from Baseline (high) if increased by >=7%; decrease from Baseline (low) if decreased by >=7%. Baseline was defined as value at W0.|Up to W24|Safety Population. Only those par. available at the specified time points were analyzed (represented as n=x,x,x,x in the category titles).||Participants|||Number
734830|NCT00428090|Secondary|Number of Participants With Adverse Events Defined by Severity|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE included significant or unexpected worsening or exacerbation of the condition/indication under study, exacerbation of a chronic or intermittent pre-existing condition, new conditions detected or diagnosed, signs, symptoms, or the clinical sequelae of a suspected overdose of either investigational product or a concurrent medication. Number of participants with any AE and as per severity were reported. Refer to the general AE/SAE module for a list of AEs and SAEs.|Up to W24|Safety population: This included all par. randomized to treatment who have taken at least one dose of study medication.||Participants|||Number
734831|NCT00428090|Secondary|Change From Baseline (W0) in Glycosylated Hemoglobin (HbA1c) at W24.|The blood sample was collected for assessments of HbA1c levels at Baseline and W24. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0. Endpoint treatment differences which were adjusted to take account of missing data are derived.|Baseline (W0) and W24|ITT Population. Only those par. available at the specified time points were analyzed (represented as n=x,x,x,x in the category titles).||Percentage (%)||Standard Error|Least Squares Mean
734832|NCT00428090|Secondary|Change From Baseline (W0) in Mini Mental State Examination (MMSE) Total Score at W24.|The MMSE consists of 11 tests of orientation, memory (recent and immediate), concentration, language and praxis. Scores range from 0 to 30, with lower scores indicating greater cognitive impairment. The scale is completed by the investigator, based on the performance of the par. and takes approximately 5 to 10 minutes to administer. The assessments was performed at Baseline and W24. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0. Endpoint treatment differences which were adjusted to take account of missing data are derived|Baseline (W0) and W24|ITT Population. Only those par. available at the specified time points were analyzed (represented as n=x,x,x,x in the category titles).||Score on a scale||Standard Error|Least Squares Mean
734860|NCT00428298|Secondary|Change From Baseline in Montgomery Asberg Depression Score at 16 Weeks|The MADRS is a 10 item depression rating scale administered by a research team member. The MADRS is composed of 10 items with a 7 point fixed rating scale (0-6). A higher score indicates the presence of depressive symptoms.|16 weeks|Discrepancies in number of participants analyzed are due to subjects who dropped out and did not have final assessments. Imputed data was used for those participants.||units on a scale||Standard Deviation|Mean
734833|NCT00428090|Secondary|Change From Baseline (W0) in Alzheimer’s Carer’s Quality of Life Instrument (ACQLI) Score at W12 and W24.|The ACQLI was an assessment of caregiver quality of life. This instrument consists of 30 questions exploring various aspects of carer’s quality of life. Each of the questions had a two point response and the 30 questions were summed to provide a total score. Items are assumed to be unidimensional (i.e., represent a single variable) and are scored 0/1 (false/true) before summation into a total score with a 0–30 range. To ease comparisons between scales, ACQLI scores were transformed to range between 0–100 (100: worse). The assessments was performed at Baseline, W12 and W24. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0. Endpoint treatment differences which were adjusted to take account of missing data are derived.|Baseline (W0) and up to W24|ITT Population. Only those par. available at the specified time points were analyzed (represented as n=x,x,x,x in the category titles).||Score on a scale||Standard Error|Least Squares Mean
734834|NCT00428090|Secondary|Time Spent Caring for Basic and Instrumental Activities Resource Utilization in Dementia (RUD) Scale at W12 and W24|The RUD instrument was developed as a comprehensive tool to assess the amount of resource use among demented par. RUD assess both formal and informal resource use of the par. and the primary caregiver, making it possible to calculate costs from a societal perspective. Q1 relates to assisting par. with basic activities of daily living and Q2 relates to instrumental activities of daily living. The assessments was performed at Baseline, W12 and W24. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0. Endpoint treatment differences which were adjusted to take account of missing data are derived.|Baseline (W0) and up to W24|ITT Population. Only those par. available at the specified time points were analyzed (represented as n=x,x,x,x in the category titles).||Hours||Standard Deviation|Mean
734835|NCT00428090|Secondary|Change From Baseline (W0) in Mean European Quality of Life -5 Dimensions Proxy Version (EQ-5D Proxy) Total Score at W12, W24 Assessed by Thermometer (Visual Analog Scale [VAS])|The EQ-5D Proxy is a 2 part scale used to assess the quality of life and utility benefit. The data for Part 2 is presented. It is a the visual analogue scale Thermometer which assessed caregiver's impression of par. overall health. The Thermometer has endpoints of 100 (best imaginable health state) and 0 (worst imaginable health state). EQ-5D Proxy assessments was performed at Baseline, W12 and W24. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0. Endpoint treatment differences which were adjusted to take account of missing data are derived.|Baseline (W0) and up to W24|ITT Population. Only those par. available at the specified time points were analyzed (represented as n=x,x,x,x in the category titles).||Score on a scale||Standard Error|Least Squares Mean
734836|NCT00428090|Secondary|Change From Baseline (W0) in Mean European Quality of Life -5 Dimensions Proxy Version (EQ-5D Proxy) Total Score at W12, W24 Assessed by Utility|The EQ-5D Proxy was a 2 part scale used to assess the quality of life and utility benefit. The data for Part 1 is presented. It is a 5 dimensional Health State Classification. Caregivers were asked to respond as they feel the par. would on dimensions of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Answers to each question were recorded on a 3-point scale which indicates the level of impairment (level 1= no problem; level 2=some or moderate problem(s) and level 3=unable, or extreme problem with higher scores indicating greater dysfunction. EQ-5D Proxy assessments was performed at Baseline, W12 and W24. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0. Endpoint treatment differences which were adjusted to take account of missing data are derived.|Baseline (W0) and up to W24|ITT Population. Only those par. available at the specified time points were analyzed (represented as n=x,x,x,x in the category titles).||Score on a scale||Standard Error|Least Squares Mean
734837|NCT00428090|Secondary|Change From Baseline (W0) in Mean Short Term Memory Assessment Total Score (ADAS-Cog Q1 Plus Q7) at W8, W16, W24|Change from Baseline in short term memory assessment score was assessed from a combined analysis of items 1 (word recall task) and 7 (word recognition task) of ADAS-Cog scale. Word recall task consist of the participants score was the mean number of words not recalled on three trials (maximum score 10) and word recognition task, to score this item the number of incorrect responses was counted (maximum error score was 12). Higher score indicating greater dysfunction. Total score is sum of individual score. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0. Endpoint treatment differences which were adjusted to take account of missing data are derived.|Baseline (W0) and up to W24|ITT Population. Only those par. available at the specified time points were analyzed (represented as n=x,x,x,x in the category titles).||Score on a scale||Standard Error|Least Squares Mean
734838|NCT00428090|Secondary|Change From Baseline (W0) in Mean Disability Assessment for Dementia (DAD) Scale Total Score at W8, W16, W24|The DAD, assessed the ability of a par. to execute basic and instrumental activities of daily living (ADL) and leisure activities. The scale consists of 40 questions assessing basic and instrumental ADLs. This scale assesses a participants’ ability to initiate, plan, and perform activities related to hygiene, dressing, continence, eating, meal preparation, telephoning, going on an outing, finance and correspondence, medications, leisure, and housework. Each item was scored as yes: 1, no: 0 and N/A: not applicable. Higher scores indicate less disability with a score of 100 indicating no disability and 0 indicating no functional ability. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0. The percentage score was calculated as (DAD total score/total number of applicable items) multiplied by 100. Endpoint treatment differences which were adjusted to take account of missing data are derived.|Baseline (W0) and up to W24|ITT Population. Only those par. available at the specified time points were analyzed (represented as n=x,x,x,x in the category titles).||Score on a scale||Standard Error|Least Squares Mean
734859|NCT00428298|Other Pre-specified|Change From Baseline in Young Mania Rating Scale (YMRS) at 16 Weeks|"The Young Mania Rating Scale has 11 items that rate the subject's subjective experience and clinician observation. Four items are rated 0-8, the remaining are rated 0-4.
The score can range from 0 to 60. A higher score indicates the presence of manic symptoms."|16 weeks|Discrepancies in number of participants analyzed are due to subjects who dropped out and did not have final assessments. Imputed data was used for those participants.||units on a scale||Standard Deviation|Mean
734873|NCT00428441|Primary|Recurrent Deep Vein Thrombosis or Pulmonary Embolism in Patients With Persistently Negative D-dimer Levels|Objectively documented deep vein thrombosis, pulmonary embolism, superficial vein thrombosis|1 year|||participants|||Number
734839|NCT00428090|Secondary|Change From Baseline (W0) in Mean Neuropsychiatric Inventory (NPI) Total Score at W8, W16, W24|The NPI assessed behavioral disturbances comprises 10 dimensions: delusions, hallucinations, dysphoria, apathy, euphoria, disinhibition, aggressiveness and agitation, irritability, anxiety and aberrant motor activity. The par. caregiver asked about behavior in the par. If “Yes”, the informant then rates both the severity on a 3-point scale, 1: mild to 3: severe (total range: 0-36) and the frequency using a 4-point scale, 1: occasionally to 4: very frequently. The total domain score was frequency × severity. The distress was scored on 5-point scale, 0: no distress to 5 - very severe or extreme. A total NPI score can be calculated by adding all domain scores together; NPI total score: from 0-144 and NPI distress score: from 0-60, all with higher scores indicating more severe behavioral disturbance. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0.|Baseline (W0) and up to W24|ITT Population. Only those participants available at the specified time points were analyzed (represented as n=x,x,x,x in the category titles). Endpoint treatment differences which were adjusted to take account of missing data are derived.||Score on a scale||Standard Error|Least Squares Mean
734840|NCT00428090|Secondary|Change From Baseline (W0) in Mean CIBIC+ Global Functioning Total Score at W8, W16, W24|The CIBIC+ assessment comprised of a 7-point rating of severity (at baseline) and change (at indicated time points). It was rated on a scale of 1 to 7 as 1: markedly improved, 2.: moderately improved, 3: minimally improved, 4: no change, 5: minimally worse, 6: moderately worse and 7: markedly worse; higher score means more dysfunction. The scale was based on interviews with the par. and caregiver and was completed by an independent rater. It required separate structured 15-20 minute interviews with the par. and caregiver. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0. Endpoint treatment differences which were adjusted to take account of missing data are derived. It was evaluated at Baseline, W8, W16 and W24.|Baseline (W0) and up to W24|ITT Population. Only those participants available at the specified time points were analyzed (represented as n=x,x,x,x in the category titles).||Score on a scale||Standard Error|Least Squares Mean
734841|NCT00428090|Secondary|Change From Baseline (W0) in Mean ADAS-Cog Total Score at W8, W16, W24|The 11-item ADAS-Cog assessed a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Most items were evaluated by tests, but some were dependent on clinician ratings on a 5-point scale. Scores ranged from 0-70 with higher scores indicating greater dysfunction. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline is defined as value at W0. Endpoint treatment differences were adjusted to take account of missing data. It was evaluated at Baseline, W8, W16 and W24.|Baseline (W0) and up to W24|ITT Population. Only those participants available at the specified time points were analyzed (represented as n=x,x,x,x in the category titles).||Score on a scale||Standard Error|Least Squares Mean
734842|NCT00428090|Primary|Change From Baseline (W0) in Mean CIBIC+ Global Functioning Total Score at W24 as a Function of APOE e4 Status in Full Population Cohort|The CIBIC+ assessment comprised of a 7-point rating of severity (at baseline) and change (at indicated time points). It was rated on a scale of 1 to 7 as 1: markedly improved, 2.: moderately improved, 3: minimally improved, 4: no change, 5: minimally worse, 6: moderately worse and 7: markedly worse; higher score means greater dysfunction. It was based on interviews with the par. and caregiver by an independent rater. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0. Endpoint treatment differences which were adjusted to take account of missing data are derived. Estimated value was calculated by Active treatment minus Placebo. A hierarchical testing procedure was used to control for the two rosiglitazone dose groups and the three genetic subgroups. There was no adjustment for the donepezil versus placebo comparisons, which were included to assess the sensitivity of the trial to detect a treatment effect.|Baseline (W0) and W24|ITT Population. Only those par. available at the indicated time points were analyzed. These comparisons were conducted in full population.||Score on a scale||Standard Error|Least Squares Mean
734843|NCT00428090|Primary|Change From Baseline (W0) in Mean CIBIC+ Global Functioning Total Score at W24 as a Function of APOE e4 Status in All Except e4/e4’s Cohort|The CIBIC+ assessment comprised of a 7-point rating of severity (at baseline) and change (at indicated time points). It was rated on a scale of 1 to 7 as 1: markedly improved, 2.: moderately improved, 3: minimally improved, 4: no change, 5: minimally worse, 6: moderately worse and 7: markedly worse; higher score means greater dysfunction. It was based on interviews with the par. and caregiver by an independent rater. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0. Endpoint treatment differences which were adjusted to take account of missing data are derived. Estimated value was calculated by Active treatment minus Placebo. A hierarchical testing procedure was used to control for the two rosiglitazone dose groups and the three genetic subgroups. There was no adjustment for the donepezil versus placebo comparisons, which were included to assess the sensitivity of the trial to detect a treatment effect.|Baseline (W0) and W24|ITT Population. Only those par. available at the indicated time points were analyzed. These comparisons were conducted in all except e4/e4’s: comprised of APOE e4 neg par. (e2/e2, e2/e3, and e3/e3) and APOE e4 heterozygote par. (e2/e4, e3/e4)||Score on a scale||Standard Error|Least Squares Mean
734844|NCT00428090|Primary|Change From Baseline (W0) in Mean CIBIC+ Global Functioning Total Score at W24 as a Function of APOE e4 Status in APOE4 Negative Cohort|The CIBIC+ assessment comprised of a 7-point rating of severity (at baseline) and change (at indicated time points). It was rated on a scale of 1 to 7 as 1: markedly improved, 2.: moderately improved, 3: minimally improved, 4: no change, 5: minimally worse, 6: moderately worse and 7: markedly worse; higher score means greater dysfunction. It was based on interviews with the par. and caregiver by an independent rater. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0. Endpoint treatment differences which were adjusted to take account of missing data are derived. Estimated value was calculated by Active treatment minus Placebo. A hierarchical testing procedure was used to control for the two rosiglitazone dose groups and the three genetic subgroups. There was no adjustment for the donepezil versus placebo comparisons, which were included to assess the sensitivity of the trial to detect a treatment effect.|Baseline (W0) and W24|ITT Population. Only those par. available at the indicated time points were analyzed. These comparisons were conducted in APOE e4 negative (neg) par. (e2/e2, e2/e3, and e3/e3).||Score on a scale||Standard Error|Least Squares Mean
734845|NCT00428090|Primary|Change From Baseline (W0) in Mean ADAS-Cog Total Score at W24 as a Function of APOE e4 Status in Full Population Cohort|The 11-item ADAS-Cog assessed a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Items were evaluated by tests and clinician ratings on a 5-point scale. Scores ranged from 0-70 with higher scores indicates more dysfunction. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline is defined as value at W0. Estimated value was calculated by Active treatment minus Placebo. A hierarchical testing procedure was used to control for the two rosiglitazone dose groups and the three genetic subgroups. There was no adjustment for the donepezil versus placebo comparisons, which were included to assess the sensitivity of the trial to detect a treatment effect.|Baseline (W0) and W24|ITT Population||Score on a scale||Standard Error|Least Squares Mean
734846|NCT00428090|Primary|Change From Baseline (W0) in Mean ADAS-Cog Total Score at W24 as a Function of APOE e4 Status in All Except e4/e4’s Cohort|The 11-item ADAS-Cog assessed a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Items were evaluated by tests and clinician ratings on a 5-point scale. Scores ranged from 0-70 with higher scores indicates more dysfunction. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline is defined as value at W0. Estimated value was calculated by Active treatment minus Placebo. A hierarchical testing procedure was used to control for the two rosiglitazone dose groups and the three genetic subgroups. There was no adjustment for the donepezil versus placebo comparisons, which were included to assess the sensitivity of the trial to detect a treatment effect.|Baseline (W0) and W24|ITT Population. Only those par. available at the indicated time points were analyzed. These comparisons were conducted in all except e4/e4’s: comprised of APOE e4 neg par. (e2/e2, e2/e3, and e3/e3) and APOE e4 heterozygote par. (e2/e4, e3/e4)||Score on a scale||Standard Error|Least Squares Mean
734847|NCT00428090|Primary|Change From Baseline (W0) in Mean ADAS-Cog Total Score at W24 as a Function of APOE e4 Status in Apolipoprotein epsilon4 (APOE e4) Negative Cohort|The 11-item ADAS-Cog assessed a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Items were evaluated by tests and clinician ratings on a 5-point scale. Scores ranged from 0-70 with higher scores indicates more dysfunction. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline is defined as value at W0. Estimated value was calculated by Active treatment minus Placebo. The adjusted means were presented. A hierarchical testing procedure was used to control for the two rosiglitazone dose groups and the three genetic subgroups. There was no adjustment for the donepezil versus placebo comparisons, which were included to assess the sensitivity of the trial to detect a treatment effect.|Baseline (W0) and W24|ITT Population. Only those par. available at the indicated time points were analyzed. These comparisons were conducted for APOE e4 negative (neg) par. (e2/e2, e2/e3, and e3/e3) cohort||Score on a scale||Standard Error|Least Squares Mean
734848|NCT00428116|Secondary|Morbidity|severe adverse events including death, pneumonia, diarrhea, and other adverse events|18 months post-randomization|||participants|||Number
734849|NCT00428116|Primary|Growth at 18 Months Post-randomization|Weight and height will be transformed to the weight-for-age Z-score (i.e., WAZ) and height-for-age Z-score (i.e., HAZ) using World Health Organization Child Growth Standards, taking into account the infant's age and gender.|18 months of post-randomization follow-up|||z-score||Inter-Quartile Range|Median
734850|NCT00428207|Secondary|Frequency of Catheter Change|Recorded by the subjects who will use a checklist to document the reason for the catheter change (routine, insufficient insulin in infusion system, unexplained hyperglycemia, catheter site irritation, suspected occlusion/kinking of catheter, loosening of catheter.|48 to 96 hours|Data collection was incomplete/insufficient and therefore end points could not be evaluated for this assessment.|||||
734851|NCT00428207|Primary|Glycemic Stability|Glycemic stability will be assessed by MAGE (Mean Amplitude of Glycemic Excursion)(5), M value of Schlichtkrull, standard deviation & coefficient of variation using 7 point finger stick blood glucose measurements performed 48-96 hours after insertion of the pump infusion catheter. Data collected 48 to 72 hours post-catheter insertion will be analyzed separately from the data collected 72 to 96 hours post-catheter insertion. The mean of the measurements taken throughout the study will be used for calculation of the primary endpoint.|48 to 96 hours|"Data collection was incomplete/insufficient and therefore endpoint could not could not be evaluated"|||||
734852|NCT00428220|Other Pre-specified|Summary of Duration of Clinical Benefit|Duration of clinical benefit is defined as the length of time participants remain on sunitinib from the first day of treatment on the parent protocol until the end of sunitinib treatment in this study (A6181114). For participants who were on placebo or a comparator drug in the parent study, duration of clinical benefit is defined as the length of time participants are on sunitinib in this study.|From the first day of treatment in parent study until last day of treatment in A6181114 study.|The safety population was defined as all participants enrolled in the study who received at least one dose of study drug in this study.||Weeks||Standard Deviation|Mean
734853|NCT00428220|Primary|Number of Participants With Treatment-emergent AEs (Treatment-Related)|Assessment of AEs included type, incidence, severity (graded by the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], Version 3.0, timing, seriousness, and relatedness; and laboratory abnormalities.|From first day of treatment on the current study up to 28 days post the last dose of study treatment|The safety population was defined as all participants enrolled in the study who received at least one dose of study drug in this study.||participants|||Number
734854|NCT00428220|Primary|Number of Participants With Treatment-emergent Adverse Events (AEs) (All Causalities)|Assessment of AEs included type, incidence, severity (graded by the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], Version 3.0, timing, seriousness, and relatedness; and laboratory abnormalities.|From first day of treatment on the current study up to 28 days post the last dose of study treatment|The safety population was defined as all participants enrolled in the study who received at least one dose of study drug in this study.||participants|||Number
734855|NCT00428246|Secondary|Effect of Paricalcitol on Kidney Function||6 weeks||||||
734856|NCT00428246|Secondary|Effect of Paricalcitol on Hypertension||6 weeks||||||
734857|NCT00428246|Primary|Endothelial Protectant Effects of Paricalcitol||6 weeks||||||
734858|NCT00428246|Primary|Anti-Inflammatory Effects of Paricalcitol|change in hsCRP level from baseline to 4 weeks|6 weeks|||micrograms||95% Confidence Interval|Mean
734861|NCT00428298|Primary|Percent Change From Baseline in Repeatable Battery for the Assessment of Neuropsychological Status at 16 Weeks|"The RBANS is a brief, independently administered measurement of cognitive decline or improvement.
The test is comprised of 12 subtests which comprise 5 domains. The age of the participant and the scores from each domain inform the total RBANS score (Index Score) analyzed in this study. The range for total score is 40-160. If the total score for a subject increases this denotes improved performance on the RBANS.
The RBANS was administered at baseline and 16 weeks."|16 weeks|Participants who completed screening/first visit Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) and study completion/last visit RBANS. Discrepancies in number of participants analyzed are due to subjects who dropped out and did not have final RBANS scores. Imputed data was used for those participants.||percentage of change||95% Confidence Interval|Mean
734862|NCT00428389|Secondary|Mean Change From Baseline in the Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Total Score at Week 25 and at the End of Study|The ADCS-ADL scale is composed of 23 items to assess the basic and instrumental activities of daily living such as those necessary for personal care, communicating and interacting with other people, maintaining a household, conducting hobbies and interests, making judgments and decisions. Responses for each item are obtained through a caregiver interview. The total score is the sum of all items and sub-questions. The range for the total ADCS-ADL score is 0 to 78; a higher score indicates a more self-sufficient individual. A positive change from baseline indicates improvement.|Baseline, Week 25 (end of the extension phase) and at the end of Study|The Intent-to-Treat (ITT) population included all randomized patients who entered the switch period for at least 1 day and had at least 1 post-baseline assessment of tolerability/safety. This outcome used observed cases without imputation (OC).||Scores on a scale||Standard Deviation|Mean
734863|NCT00428389|Secondary|Mean Change From Baseline in Neuropsychiatric Inventory - 10 Item (NPI-10) Score at Week 25 and at the End of Study.|The NPI-10 assesses a wide range of behavior problems encountered in dementia patients. The 10 behavioral domains comprising the NPI-10 are evaluated through an interview of the caregiver by a mental health professional. The scale includes both frequency and severity ratings of each domain as well as a composite domain score (frequency x severity). The sum of the composite scores for the 10 domains yields the NPI total score, which ranges from 0 to 120, the lower the score the less severe the symptoms. A negative change score from baseline indicates improvement.|Baseline, Week 25 (end of the extension phase) and at End of Study|The Intent-to-Treat (ITT) population included all randomized patients who entered the switch period for at least 1 day and had at least 1 post-baseline assessment of tolerability/safety. This outcome used observed cases without imputation (OC).||Scores on a scale||Standard Deviation|Mean
734864|NCT00428389|Secondary|Mean Change From Baseline in Mini Mental State Exam (MMSE) Score at Week 25 and at the End of Study|The MMSE is a brief, practical screening test for cognitive dysfunction. The test consists of five sections (orientation, registration, attention-calculation, recall, and language); the total score can range from 0 to 30, with a higher score indicating better function. A positive change score indicates improvement.|Baseline and Week 25 (end of the extension phase) and at the end of study|The Intent-to-Treat (ITT) population included all randomized patients who entered the switch period for at least 1 day and had at least 1 post-baseline assessment of tolerability/safety. This outcome used observed cases without imputation (OC).||Scores on a scale||Standard Deviation|Mean
734865|NCT00428389|Secondary|Mean Change From Baseline in the Clinical Global Impression of Change (CGIC) Score at Week 5 and Week 25|The CGIC is an assessment tool used by a skilled clinician to make a judgment of the severity or a change of a patient’s condition. The clinician relies solely on information obtained from the patient at the Baseline visit as well as clinical information obtained throughout the study period. The clinician does not have access to any post-baseline cognitive testing data. The CGIC is rated on a seven-point scale, ranging from (1) “very much improved” to (4) “no change” to (7) “very much worse”.|Baseline, Week 5 (end of the core phase) and Week 25 (end of the extension phase)|The Intent-to-Treat (ITT) population included all randomized patients who entered the switch period for at least 1 day and had at least 1 post-baseline assessment of tolerability/safety. This outcome used observed cases without imputation (OC).||Scores on a scale||Standard Deviation|Mean
734866|NCT00428389|Secondary|Number of Participants Who Discontinued From Study Due to Any Reason During Extension Phase|A secondary assessment of the safety and tolerability of 2 paradigms for switching from donepezil to rivastigmine patch in patients with Alzheimer's disease (AD) was the number of participants who discontinued from the study due to any reason during extension phases of the study.|From week 5 through the end of extension phase (25 weeks)|The Safety population consisted of all randomized patients who had at least 1 post-baseline safety assessment. Patients were analyzed according to the treatment received.||Participants|||Number
734867|NCT00428389|Secondary|Number of Participants Who Discontinued From the Study Due to Any Adverse Event (AE) During the Combined Core and Extension Phases of the Study|A secondary assessment of the safety and tolerability of 2 paradigms for switching from donepezil to rivastigmine patch in patients with Alzheimer’s disease (AD) was the number of participants who discontinued from the study due to an AE during the combined core and extension phases of the study.|Baseline through the end of study (25 weeks)|The Safety population consisted of all randomized patients who had at least 1 post-baseline safety assessment. Patients were analyzed according to the treatment received.||Participants|||Number
734868|NCT00428389|Primary|Number of Participants Who Discontinued From the Study Due to Any Reason During the Core Phase of the Study|The primary objective of the study was to evaluate the safety and tolerability of 2 paradigms for switching from donepezil to rivastigmine patch in patients with Alzheimer’s disease (AD). The primary variable to assess tolerability of switching was the number of participants who discontinued from the study due to any reason during the core phase.|Baseline through the end of the core phase of the study (Week 5)|The Safety population consisted of all randomized patients who had at least 1 post-baseline safety assessment. Patients were analyzed according to the treatment received.||Participants|||Number
734869|NCT00428441|Secondary|Mortality||3 months||||||
734870|NCT00428441|Secondary|Incidence of Major Bleeding in Patients Who Resumed Oral Anticoagulant Therapy||3 months||||||
734871|NCT00428441|Secondary|Recurrent Deep Vein Thrombosis or Pulmonary Embolism in Patients Who Resumed Oral Anticoagulant Therapy||3 months||||||
734872|NCT00428441|Primary|Rate of Patients With Altered D-dimer Levels and Temporal Distribution of Alterations||3 months||||||
734874|NCT00428584|Other Pre-specified|Primary Outcome - Extension Phase: Visual Analog Scale (VAS) of Patients Reported Pain; Change in Mean VAS at Pre-injection and 30 Minutes Post Injection||Pre-injection and 30 minutes post injection|3 subjects discontinued and withdrew consent from the Betaseron to the new formulation of rebif group in the Extension Phase||Millimeters||Full Range|Mean
734875|NCT00428584|Other Pre-specified|Secondary Outcome - Extension Phase: Diameter in Injection Site Redness||1 to 72 hours post injection|3 subjects discontinued and withdrew consent from the Betaseron to Rebif New Formulation Group in the Extension Phase||Millimeters||Standard Deviation|Mean
734876|NCT00428584|Other Pre-specified|Secondary Outcome - Extension Phase: Number of Pain Free Patients at 30 Minutes Post Injection||Pain free patients at 30 minutes post injection|3 subjects discontinued and withdrew consent from the Betaseron to the new formulation of rebif group in the Extension Phase||Participants|||Number
734877|NCT00428584|Other Pre-specified|Secondary Outcome - Extension Phase: Change in Mean VAS at Pre-injection and 10 Minutes Post Injection||Pre-injection and 10 minutes post injection|3 subjects discontinued and withdrew consent from the Betaseron to the new formulation of rebif group in the Extension Phase||Millimeters||Full Range|Mean
734878|NCT00428584|Other Pre-specified|Secondary Outcome - Extension Phase: Change in Mean (mm) VAS for Pre-injection and Immediately After Injection Timepoints|A visual analog scale (VAS) ranging from 0 to 100 mm on which subjects rate pain from no pain (0 mm) to worst possible pain (100 mm) was used. Mean VAS of 21 injections for each patient at pre-injection compared to mean VAS of 21 injections for each patient immediately after injection.|Pre-injection and immediately after injection|3 subjects discontinued and withdrew consent from the Betaseron to the new formulation of rebif group in the Extension Phase||millimeters||Full Range|Mean
734879|NCT00428584|Secondary|Diameter of Injection Site Redness|Blinded assessment of mean change in diameter of redness (in mm) at an injection site following an injection|1-72 hours post injection over the first 12 weeks including the titration period|One subject from the new formulation of rebif group discontinued due to pregnancy||mm||Standard Deviation|Mean
734880|NCT00428584|Secondary|Number of Pain Free Patients at 30 Minutes Post-injection|"A visual analog scale (VAS) ranging from 0 to 100 mm on which subjects rate pain from no pain (0 mm) to worst possible pain (100 mm) was used.
Pain-free was defined as a VAS score of 0 for all 21 full-dose injections for the Intent-to-Treat (ITT) population."|30 minutes post injection|One subject from the new formulation of rebif group discontinued due to pregnancy||Participants|||Number
734881|NCT00428584|Secondary|Change in Mean VAS for the 21 Full-dose Injections at Pre-injection and 10 Minutes Post-injection Timepoints|A visual analog scale (VAS) ranging from 0 to 100 mm on which subjects rate pain from no pain (0 mm) to worst possible pain (100 mm) was used. Mean VAS of 21 injections for each patient at pre-injection compared to mean VAS of 21 injections for each patient 10 minutes post injection.|Pre-injection to 10 minutes post-injection|One subject from the new formulation of Rebif group discontinued due to pregnancy||Millimeters||Full Range|Mean
734882|NCT00428584|Secondary|Change in Mean VAS for the 21 Full-dose Injections at Pre-injection and Immediately After Injection Timepoints|A visual analog scale (VAS) ranging from 0 to 100 mm on which subjects rate pain from no pain (0 mm) to worst possible pain (100 mm) was used. Mean VAS of 21 injections for each patient at pre-injection compared to mean VAS of 21 injections for each patient immediately after injection.|Pre-Injection to Immediately after Injection|One subject from the new formulation of rebif group discontinued due to pregnancy||millimeters||Full Range|Mean
734883|NCT00428584|Primary|Visual Analog Scale (VAS) of Patient Reported Pain: Change in Mean VAS for the 21 Full-dose Injections at Pre-injection and 30 Minutes Post-injection Timepoints|Subject reported perception of pain on the VAS where the slash drawn by the patient represents pain of increasing intensity from 0 (no pain) to 100 (worse possible pain), measured in millimeters. Mean VAS of 21 injections for each patient at pre-injection compared to mean VAS of 21 injections for each patient 30 minutes post-injection|From pre-injection to 30 minutes post injection of the VAS pain scores across the first 21 injections of full dose therapy of a new formulation of rebif and Betaseron|One subject from the new formulation of rebif group discontinued due to pregnancy therefore, data for the Full Dose Calculation 30min Mean Change was not calculated||mm||Full Range|Mean
734884|NCT00428597|Secondary|EORTC QLQ-C30 - Pain Subscale|EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal|PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability.||scores on a scale||Standard Deviation|Mean
734885|NCT00428597|Secondary|EORTC QLQ-C30 - Nausea and Vomiting Subscale|EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal|PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability.||scores on a scale||Standard Deviation|Mean
734886|NCT00428597|Secondary|EORTC QLQ-C30 - Insomnia Subscale|EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal|PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability.||scores on a scale||Standard Deviation|Mean
734887|NCT00428597|Secondary|EORTC QLQ-C30 - Financial Difficulties Subscale|EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal|PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability.||scores on a scale||Standard Deviation|Mean
734888|NCT00428597|Secondary|EORTC QLQ-C30 - Fatigue Subscale|EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal|PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability.||scores on a scale||Standard Deviation|Mean
734889|NCT00428597|Secondary|EORTC QLQ-C30 - Dyspnea Subscale|EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal|PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability.||scores on a scale||Standard Deviation|Mean
734890|NCT00428597|Secondary|EORTC QLQ-C30 - Diarrhea Subscale|EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal|PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability.||scores on a scale||Standard Deviation|Mean
734891|NCT00428597|Secondary|EORTC QLQ-C30 - Constipation Subscale|EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal|PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability.||scores on a scale||Standard Deviation|Mean
734892|NCT00428597|Secondary|EORTC QLQ-C30 - Appetite Loss Subscale|EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal|PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability.||scores on a scale||Standard Deviation|Mean
734893|NCT00428597|Secondary|EORTC QLQ-C30 - Social Functioning Subscale|EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal|PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability.||scores on a scale||Standard Deviation|Mean
734894|NCT00428597|Secondary|EORTC QLQ-C30 - Role Functioning Subscale|EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal|PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability.||scores on a scale||Standard Deviation|Mean
734939|NCT00429143|Secondary|Incidence of Grades III-IV GVHD|"To determine the incidence and severity of GVHD in these patients using a combination of cyclophosphamide, tacrolimus and mycophenolate mofetil (MMF) as GVHD prophylaxis.'
Severity was graded using CTCAE 3.0 (1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death)"|6 months|Two patients died prior to expected engraftment. Two patients who rejected were retransplanted and were evaluable for GVHD.||participants|||Number
734940|NCT00429143|Secondary|Lymphoid Recovery|To assess the pace of lymphoid recovery in this patient population.|6 months|Two patients did not engraft, two patients died prior to expected day of engraftment||participants|||Number
734895|NCT00428597|Secondary|EORTC QLQ-C30 - Physical Functioning Subscale|EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal|PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability.||scores on a scale||Standard Deviation|Mean
734896|NCT00428597|Secondary|EORTC QLQ-C30 - Emotional Functioning Subscale|EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal|PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability.||scores on a scale||Standard Deviation|Mean
734897|NCT00428597|Secondary|EORTC QLQ-C30 - Cognitive Functioning Subscale|EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal|PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles with less than 10 subjects are not reported due to lack of statistical reliability.||scores on a scale||Standard Deviation|Mean
734898|NCT00428597|Secondary|European Organization for Research and Treatment of Cancer Quality of LifeQuestionnaire (EORTC QLQ-C30) - Global Quality of Life (QoL) Subscale|EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal|Patient Reported Outcome (PRO) population=subjects from the ITT population who had completed at least 1 EORTC QLQ-C30 assessment while on treatment. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability.||scores on a scale||Standard Deviation|Mean
734899|NCT00428597|Secondary|Overall Survival (OS)|Time in months from time of randomization to date of death due to any cause. The median number of months is provided; however, the study was terminated early. OS data was not mature by the time of analysis. Median OS time cannot be accurately estimated by Kaplan-Meier method for either treatment arm.|From start of study treatment up to 22 months|ITT. The median OS in months could not be calculated for placebo.||months||95% Confidence Interval|Median
734900|NCT00428597|Secondary|Time-to-Tumor Response (TTR)|Time from randomization to the first documentation of objective tumor response (CR or PR) that was subsequently confirmed.|From time of randomization through Day 1 of Week 5, 9, and every 8 weeks thereafter|ITT. TTR was calculated for the subgroup of subjects with objective response. 8 sunitinib subjects reported CR or PR response and were analyzed for TTR; no placebo subjects reported CR or PR.||Months||Full Range|Median
734901|NCT00428597|Secondary|Duration of Response (DR)|Time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause. DR was calculated as (the date of the first documentation of objective tumor progression or death due to any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4.|From start of treatment through Day 1 of Week 5, 9, and every 8 weeks thereafter until disease progression or death due to any cause|ITT. DR was calculated for the subgroup of subjects with objective response. 8 sunitinib subjects reported CR or PR response and were analyzed for DR; no placebo subjects reported CR or PR.||Months||Full Range|Median
734902|NCT00428597|Secondary|Number of Subjects With Objective Response|Objective response = subjects with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) for at least 4 weeks, confirmed by repeat tumor assessments. A CR was defined as the disappearance of all target lesions. A PR was defined as a > = 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|From time of randomization through Day 1 of Week 5, 9, and every 8 weeks thereafter|ITT. No placebo subjects had objective response.||participants|||Number
734903|NCT00428597|Primary|Progression Free Survival (PFS)|Time from randomization to first progression of disease (PD) or death for any reason in the absence of documented PD. PFS was calculated as (first event date minus first randomization date +1) divided by 30.4.|From time of randomization through Day 1 of Week 5, Week 9, and then every 8 weeks thereafter until disease progression or death|Intent-to-treat (ITT) population = all subjects who were randomized.||Months||95% Confidence Interval|Median
734912|NCT00428792|Secondary|Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Attention Deficit Subscale Teacher Rating|Teacher rating of the attention deficit subscale (9 items), one of 3 subscales in the FBB-ADHS. Each item is rated on a scale of 0 = not at all up to 3 = very much. The rating was completed by teachers on Friday afternoon of each week of the study. A total score (sum of all items divided by 9) was calculated. The total score can range from 0 to 3. A lower score indicates more ADHD.|Friday of each of the 2 treatment weeks|Intent to treat (ITT) population: All randomized patients with at least one post-baseline measurement of the primary endpoint in both study periods.||Units on a scale||Standard Deviation|Mean
734941|NCT00429143|Secondary|Engraftment Rates|To assess hematopoietic engraftment rates.|6 months|Two patients died prior to expected engraftment day||participants|||Number
734904|NCT00428792|Secondary|Clinical Global Impression (CGI-I) Scale Score – Physician Rating of Improvement (Change in State)|The CGI-I is a scale to assess improvement (change in state) of illness. The rating is based on the investigator answering one question: “Compared to the patient’s condition prior to medication, this patient’s condition is: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment.” The investigator compares the patient’s overall clinical condition to the 1 week period just prior to the initiation of medication.|Saturday of each of the 2 treatment weeks|Intent to treat (ITT) population includes all randomized patients with at least one post-baseline measurement of the primary endpoint in both study periods. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.||Units on a scale||Standard Deviation|Mean
734905|NCT00428792|Secondary|Clinical Global Impression Severity (CGI-S) Scale Score – Physician Rating of Severity|The CGI-S is a scale to assess the global severity of illness. The rating is determined by the investigator answering one question: “Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?” Ratings are on a 7-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. The rating is based upon the average observed and reported symptoms, behavior, and function in the past 7 days.|Saturday of each of the 2 treatment weeks|Intent to treat (ITT) population: All randomized patients with at least one post-baseline measurement of the primary endpoint in both study periods.||Units on a scale||Standard Deviation|Mean
734906|NCT00428792|Secondary|10-Minute Math Test – Problems Solved|The 10-Minute Math Test is a paper and pencil test consisting of several pages of math problems requiring addition, subtraction, multiplication and division calculations presented in ascending order of difficulty during a 10-minute period. Test difficulty was altered for subjects at different skill levels and ages. The number of problems attempted is an objective measure related to “academic productivity”. The math test was carried out on the Saturday visit at the end of each of the 2 treatment weeks under supervision of a teacher who had been trained on this test.|Saturday of each of the 2 treatment weeks|Intent to treat (ITT) population: All randomized patients with at least one post-baseline measurement of the primary endpoint in both study periods.||Problems solved||Standard Deviation|Mean
734907|NCT00428792|Secondary|10-Minute Math Test – Problems Attempted|The 10-Minute Math Test is a paper and pencil test consisting of several pages of math problems requiring addition, subtraction, multiplication and division calculations presented in ascending order of difficulty during a 10-minute period. Test difficulty was altered for subjects at different skill levels and ages. The number of problems attempted is an objective measure related to “academic productivity”. The math test was carried out on the Saturday visit at the end of each of the 2 treatment weeks under supervision of a teacher who had been trained on this test.|Saturday of each of the 2 treatment weeks|Intent to treat (ITT) population includes all randomized patients with at least one post-baseline measurement of the primary endpoint in both study periods. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.||Problems attempted||Standard Deviation|Mean
734908|NCT00428792|Primary|Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Teacher Rating in the Per Protocol (PP) Population|The FBB-ADHS is a 20-item rating scale. Each item describes a typical ADHD symptom. The 20 items are divided into 3 subscales: Attention deficits (9 items), hyperactivity (7 items), and impulsiveness (4 items). Each item is rated on a scale of 0 = not at all up to 3 = very much. The FBB-ADHS was completed by teachers on Friday afternoon of each week of the study. A total score (sum of all items divided by 20) was calculated. The total score can range from 0 to 3. A lower score indicates more ADHD.|Friday of each of the 2 treatment weeks|Per protocol (PP) population: All patients in the ITT population who (a) met the inclusion/exclusion criteria liable to affect the efficacy assessment and (b) did not violate the protocol in a manner liable to affect the efficacy assessment.||Units on a scale||Standard Deviation|Mean
734909|NCT00428792|Secondary|Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Parent Rating|The FBB-ADHS is a 20-item rating scale. Each item describes a typical ADHD symptom. The 20 items are divided into 3 subscales: Attention deficits (9 items), hyperactivity (7 items), and impulsiveness (4 items). Each item is rated on a scale of 0 = not at all up to 3 = very much. The FBB-ADHS was completed by teachers on Friday afternoon of each week of the study. A total score (sum of all items divided by 20) was calculated. The total score can range from 0 to 3. A lower score indicates more ADHD.|Saturday of each of the 2 treatment weeks|Intent to treat (ITT) population: All randomized patients with at least one post-baseline measurement of the primary endpoint in both study periods.||Units on a scale||Standard Deviation|Mean
734910|NCT00428792|Secondary|Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Impulsiveness Subscale Teacher Rating|Teacher rating of the hyperactivity subscale (4 items), one of 3 subscales in the FBB-ADHS. Each item is rated on a scale of 0 = not at all up to 3 = very much. The rating was completed by teachers on Friday afternoon of each week of the study. A total score (sum of all items divided by 4) was calculated. The total score can range from 0 to 3. A lower score indicates more ADHD.|Friday of each of the 2 treatment weeks|Intent to treat (ITT) population: All randomized patients with at least one post-baseline measurement of the primary endpoint in both study periods.||Units on a scale||Standard Deviation|Mean
734911|NCT00428792|Secondary|Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Hyperactivity Subscale Teacher Rating|Teacher rating of the hyperactivity subscale (7 items), one of 3 subscales in the FBB-ADHS. Each item is rated on a scale of 0 = not at all up to 3 = very much. The rating was completed by teachers on Friday afternoon of each week of the study. A total score (sum of all items divided by 7) was calculated. The total score can range from 0 to 3. A lower score indicates more ADHD.|Friday of each of the 2 treatment weeks|Intent to treat (ITT) population: All randomized patients with at least one post-baseline measurement of the primary endpoint in both study periods.||Units on a scale||Standard Deviation|Mean
734938|NCT00429104|Primary|Number of Participants With Tumor Response (Stable Disease)|Number of participants with response defined as stable disease or better using Response Evaluation Criteria In Solid Tumors (RECIST) at the month 2 evaluation.|2 months|Analysis was per protocol, and of 18 enrolled, one participant was inevaluable.||participants|||Number
734913|NCT00428792|Primary|Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Teacher Rating in the Intent-to-Treat (ITT) Population|The FBB-ADHS is a 20-item rating scale. Each item describes a typical ADHD symptom. The 20 items are divided into 3 subscales: Attention deficits (9 items), hyperactivity (7 items), and impulsiveness (4 items). Each item is rated on a scale of 0 = not at all up to 3 = very much. The FBB-ADHS was completed by teachers on Friday afternoon of each week of the study. A total score (sum of all items divided by 20) was calculated. The total score can range from 0 to 3. A lower score indicates more ADHD.|Friday of each of the 2 treatment weeks|Intent to treat (ITT) population: All randomized patients with at least one post-baseline measurement of the primary endpoint in both study periods.||Units on a scale||Standard Deviation|Mean
734914|NCT00428844|Secondary|Pharmacokinetic Parameter: Area Under the Concentration-time Curve During a Dosing Interval at Steady State (AUCss)|The pharmacokinetic (PK) parameters of daptomycin at steady state for the 6 mg/kg and 8 mg/kg dose groups. On treatment day 4, PK samples for daptomycin levels were to be obtained prior to start of daptomycin infusion (0 hr) and at 0.5 hr (end of infusion), 1-1.5 hr, 3-5 hr, 8-12 hr, and 24 hr after the start of daptomycin infusion.|Day 4 (steady state)|Pharmacokinetic evaluable population. Pharmacokinetics not analyzed for the comparator group.||µg•hr/mL||Full Range|Median
734915|NCT00428844|Secondary|Pharmacokinetic Parameter: Maximum Plasma Concentration (Cmax)|The pharmacokinetic (PK) parameters of daptomycin at steady state for the 6 mg/kg and 8 mg/kg dose groups. On treatment day 4, PK samples for daptomycin levels were to be obtained prior to start of daptomycin infusion (0 hr) and at 0.5 hr (end of infusion), 1-1.5 hr, 3-5 hr, 8-12 hr, and 24 hr after the start of daptomycin infusion.|Day 4 (steady state)|Pharmacokinetic evaluable population. Pharmacokinetics not analyzed for the comparator group.||µg/mL||Full Range|Median
734916|NCT00428844|Secondary|Microbiological Response|Sponsor’s assessment of subject-level microbiological response at the test-of-cure visit for the modified Intent-to-Treat (mITT) population.|Approximately 6 weeks post last dose (approximately week 12)|Modified Intent to Treat Population. Six treated patients in the ITT population were not included in the mITT population, as they did not have confirmed baseline staphylococcal infection.||Participants|||Number
734917|NCT00428844|Secondary|Overall Clinical Outcome|The sponsor determined overall clinical outcome based on blinded review of clinical, microbiological, and radiological response of the subject including, but not limited to, clinical signs and symptoms of PJI, microbiological assessments, radiographic findings, and surgical procedures performed. Subjects were a success if both clinical and microbiological responses were success. A subject who failed to respond clinically or microbiologically was a failure. If microbiological response was non-evaluable and/or clinical evaluation at TOC was not performed, the subject was non-evaluable.|Approximately 6 weeks post last dose (approximately week 12)|Modified Intent-to-Treat Population. Six treated patients in the ITT population were not included in the mITT population, as they did not have confirmed baseline staphylococcal infection.||Participants|||Number
734918|NCT00428844|Secondary|Safety - Notable Laboratory Abnormalities|Summary of Notable Laboratory Abnormalities - description of the proportion of subjects within each treatment group that had clinical laboratory values outside the reference range.|From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)|Safety Population||Participants|||Number
734919|NCT00428844|Primary|Any Creatine Phosphokinase (CPK) Elevation > 500 Units Per Liter (U/L)|Number of subjects with CPK >500 U/L between Day 3 and 7 days following the last dose of study medication (Day 7P) as measured by the central laboratory.|From the 3rd day of therapy to 1 week post last dose (approximately week 7)|Safety Population||Participants|||Number
734920|NCT00428922|Secondary|Changes in CECs as Predictors of PFS and Clinical Benefit|Circulating endothelial cells (CECs) are to be collected day 1 prior to treatment and day 22 prior to treatment. These samples are to be collected at the PI‘s discretion based upon the availability of the cell processing laboratory, the patients will be informed when consented if the samples will collected or not.|Day 1 and Day 22|CEC data was not collected and available for analysis|||||
734921|NCT00428922|Secondary|Overall Clinical Benefit Rate (CR+PR+SD)|Defined as best response of CR or PR or stable disease for at least 24 weeks. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (POD); POD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions|at least 24 weeks|||percent of patients||95% Confidence Interval|Number
734922|NCT00428922|Secondary|Changes in CTCs as Predictors of PFS and Clinical Benefit|Circulating tumor cells (CTCs) evaluated at baseline (day 1 of treatment) and after 1 treatment cycle (day 22 prior to cycle 2 treatment).|Day 1 and Day 22|Due to sample size, could not perform any statistical analysis to correlate the baseline CTCs with PFS and response rate. Samples only available for 50% of the patients.||patients with detected CTCs|||Number
734923|NCT00428922|Primary|Progression-free Survival (PFS) and to Evaluate Safety of the Trastuzumab, Bevacizumab and Docetaxel Regimen.|The trial was designed as a single-stage phase II rather then usual two-stage design because of the progression free survival (PFS) primary endpoint, as it is impractical to wait to assess PFS for patients in the first stage. We will consider a PFS of 50% at twelve months (median PFS of 12 months) or less uninteresting and a PFS of 70% at twelve months (median PFS of twenty months) worthy of pursuing the regimen in a future trials. The single-stage design is as follows: p0=0.50, p1=0.70, α=0.10, β= 0.10. This leads to a total sample size of 39 patients, 24 or higher of who are progression-free at 12 months.|up to 3 years|||months||95% Confidence Interval|Median
734924|NCT00428948|Secondary|Percentage of Participants With a Clinically Sustained Decrease of Blood Pressure Leading to a Sustained Reduction in Antihypertensive Therapy From Baseline to Month 36||Baseline to Month 36|Intent-to-treat population: All randomized participants with at least 4 months of follow-up. Only participants taking antihypertensive medication at Baseline with available data were included in the analysis.||Percentage of participants|||Number
734969|NCT00429364|Secondary|Annual Rate of Change in Upper to Lower Segment Ratio||Up to 3 years following randomization.|All randomized participants whose upper to lower segment ratios were measured at baseline and at any of the follow-up visits.||1/year||Standard Error|Least Squares Mean
734925|NCT00428948|Secondary|Number of Hypertensive Events Per 100 Follow-up Years in Non-hypertensive Participants From Baseline to Month 36|A hypertensive event was defined as a change from non-hypertensive (systolic BP ≤ 139 mmHg and diastolic BP ≤ 89 mmHg without taking antihypertensive medications) status to 1 of 3 conditions: (1) High pre-hypertensive (systolic BP [sBP] > 129 mmHg and/or diastolic BP [dBP] > 84 mmHg), (2) hypertensive (sBP > 139 mmHg and/or dBP > 89 mmHg), or (3) requiring antihypertensive therapy.|Baseline to Month 36|Intent-to-treat population: All randomized participants with at least 4 months of follow-up. Only non-hypertensive participants with available data were included in the analysis.||Events/100 follow-up years|||Number
734926|NCT00428948|Secondary|Area Under the Concentration-time Curve of Change in Renal Pain From Baseline to Month 36|Change from baseline in renal pain was assessed by a 0 to 10 pain scale as average area under the concentration-time curve (AUC) between baseline and the last trial visit or the last visit prior to initiating medical (eg, narcotic or anti-nociceptives [eg, tricyclic antidepressants]) or surgical therapy for pain. In the pain scale, score 0 represented no pain at all and score 10 represented the worst pain. A negative change score indicates less pain. AUC of renal pain was derived from renal pain scores within treatment period and was calculated using the trapezoidal rule, by dividing the number of days between the first and last assessment.|At screening, Baseline, Day 1, every 4 months up to month 36/early tremination (ET), follow-up visit 1 and 2|Intent-to-treat population: All randomized participants with at least 4 months of follow-up. Only participants with available data were included in the analysis.||units on a scale||Standard Deviation|Mean
734927|NCT00428948|Secondary|Change in Mean Arterial Blood Pressure Per Year in Non-hypertensive Participants From Baseline to Month 36|For participants who were non-hypertensive (systolic BP ≤ 139 mmHg and diastolic BP ≤ 89 mmHg without taking antihypertensive medications) at baseline, mean arterial blood pressure was measured at scheduled clinic visits up to the point of exposure to antihypertensive therapy for any reason. The change in mean arterial blood pressure per year was based on the slope of blood pressure, obtained by regressing blood pressure against time by subject.|Baseline to Month 36|Intent-to-treat population: All randomized participants with at least 4 months of follow-up. Only non-hypertensive participants with available data were included in the analysis.||mmHg||Standard Deviation|Mean
734928|NCT00428948|Secondary|Change in Renal Function Per Year From Week 3 to Month 36|Renal function was assessed using serum creatinine measurements and was estimated using 1/serum creatinine. The formula for 1/serum creatinine is: 1/Pcr, where Pcr = serum creatinine concentration (mg/dL). The change in renal function per year was based on the slope of change, obtained by regressing renal function data against time by subject.|Week 3 to Month 36|Intent-to-treat population: All randomized participants with at least 4 months of follow-up. Only participants with available data were included in the analysis.||(mg/mL)^-1 per year||Standard Deviation|Mean
734929|NCT00428948|Secondary|Number of ADPKD Clinical Progression Events Per 100 Follow-up Years From Baseline to Month 36|These ADPKD events in the key secondary Outcome Measure were selected on the basis of their potential relationship to progressing cystogenesis. Reducing the rate of cyst development and expansion would likely slow the progression of ADPKD. The 4 events were: (1) Onset or progression of hypertension (someone is hypertensive if they have > 139 mmHg systolic blood pressure [BP], > 89 mmHg diastolic BP, or if they are taking antihypertensive medication at any BP level); (2) severe renal pain requiring medical intervention; (3) worsening albuminuria (by category, see below); and (4) worsening renal function, defined as a 25% decrease in 1/serum creatinine from Baseline. Albuminuria was assessed using spot urine albumin/creatinine ratio measurements (all measurements in mg/mmol). Categories included normal (< 2.8 female or < 2.0 male), microalbuminuria (2.8-28 female or 2.0-20 male), and overt proteinuria (> 28 female or > 20 male.|Baseline to Month 36|Intent-to-treat population: All randomized participants. Only participants with available data were included in the analysis.||Events/100 follow-up years|||Number
734930|NCT00428948|Primary|Percentage Change Per Year in Total Kidney Volume From Baseline to Month 36|Kidney volume was assessed in T1-weighted magnetic resonance images collected at each study site and sent to a central reviewing facility. At the central reviewing facility, blinded radiologists used proprietary software to measure the volume of both kidneys.|Baseline to Month 36|Intent-to-treat population: All randomized participants who had Baseline and post-baseline observations of total kidney volume. Only participants with available data were included in the analysis.||Percentage change per year||Standard Deviation|Mean
734931|NCT00428974|Secondary|Relationship Between Peripheral Blood Mononuclear Cell Adenosine A3 Receptor (A3AR) Expression Level at Baseline and Response to Therapy.|A3AR is measured biochemically and the expression level on cells from patients with disease is compared to that from healthy volunteer levels and expressed as a ratio|12 weeks||||||
734932|NCT00428974|Secondary|Individual PASI Components Redness, Thickness, and Scale|Each component is scored as 0 (clear, no disease) to 24 (most severe score); lower scores indicate improvement|12 weeks||||||
734933|NCT00428974|Secondary|"The Number of Patients Who Achieve a Score of Almost Clear or Clear by Physician's Global Assessment (PGA)"|PGA is a scale from 0 (clear, no disease) to 5 (most severe score); patients who improve to 0 (clear) or 1 (minimal disease) are tabulated in this outcome|12 weeks|||Number of treated patients|||Number
734934|NCT00428974|Primary|Frequency and Nature of Adverse Events||12 weeks||||||
734935|NCT00428974|Primary|Change From Baseline (CFB) in Psoriasis Area and Severity Index (PASI) Score|PASI scale is sum of redness, thickness, and scale scores, ranging from 0 (no disease) to 72 (most severe possible score); lower scores, i..e., negative change from baseline, indicate improvement|12 weeks minus baseline|||Scores on a scale||Standard Deviation|Mean
734936|NCT00429026|Primary|Survival Rate|Number of participants surviving at 4 years compared to total participants, to compare the overall survival of metastatic renal cell carcinoma (RCC) patients undergoing HLA-matched related donor nonmyeloablative allogeneic hematopoietic stem cell transplantation (NST) using fludarabine-melphalan (FM) versus fludarabine-cyclophosphamide (FC) conditioning regimen. Evaulation after 1, 2, 3, 6, 9, & 12 months, then every 4 months for 4 years.|Up to 4 years|Primary outcome measure was not assessed due to early study termination, e.g. patients did not receive assigned treatment.|||||
734937|NCT00429104|Secondary|Duration of Stable Disease|Stable disease is measured from the start of the treatment until the RECIST criteria for disease progression is met.|6 Years|Analysis was per protocol, and of 18 enrolled, one participant was inevaluable.||weeks||Full Range|Median
734942|NCT00429143|Primary|Optimal Dose of CD3+ Donor Lymphocytes (T-cells) for Consistent Engraftment Without GVHD|"To determine the optimal dose of CD3+ donor lymphocytes required for consistent engraftment without the development of grade III/IV GVHD.
Measured as CD3+ donor lymphocytes given as n x 10^8/kg.
n was found to be 2 and was found to be the optimal dose and was the only dose given."|6 months|Two patients died prior to expected day of engraftment||lymphocytes x 10^8/kg|||Number
734943|NCT00429143|Primary|Overall Survival of Participants|To determine overall survival at 6 months post-transplant.|6 months|27 Patients undergoing haploidentical transplant at Thomas Jefferson University||participants|||Number
734944|NCT00429169|Secondary|Brain Activity Measured by BOLD Signal With fMRI During a Reward Processing Task.|Comparison of fMRI results at baseline and after 8 weeks of antidepressant pharmacotherapy with paroxetine vs. bupropion.|Baseline and Week 8.||||||
734945|NCT00429169|Primary|Occurrence of Suicidal Ideation or Acts Necessitating a Change in Treatment|Suicide attempts, other suicidal behavior, or increase in suicidal thoughts that required a change in clinical treatment.|Measured at Month 6|These were the number of subjects with analyzable data.||Events|||Number
734946|NCT00429169|Primary|Scale for Suicidal Ideation|The clinician-rated Beck Scale for Suicidal Ideation (SSI) (Beck et al 1979)was used weekly for 8 weeks. It has 19 items scaled 0 (least severe) to 2 (most severe) and total score is the sum, ranging 0 to 38 (Beck et al 1979). Items measure frequency, intensity, and attitudes toward suicidal thoughts, feelings of control over them, and suicide plans. Mean score in 90 inpatients hospitalized for suicidal ideation was 9.4±8.4, versus 4.4±5.8 in outpatients as cited in the study by Beck et al, 1979.|Baseline and Week 8|The study was powered for N=50 subjects per group based on naturalistic pilot data from our clinic. An interim data analysis showed an interaction of treatment with baseline suicidal ideation severity on follow-up ideation. After consulting with clinical colleagues, statisticians and the IRB, a decision was made to stop enrollment.||Points on Scale for Suicidal Ideation||Standard Deviation|Mean
734947|NCT00429169|Primary|Go-No go Test|Change in neuropsychological measure of impulsivity. Computer-based task involving induction of a dominant response tendency and testing of the subject's ability to withhold responding to less frequent non-target stimuli.|Measured at Baseline and Week 8|These were the number with analyzable data||Commission errors||Standard Deviation|Mean
734948|NCT00429182|Secondary|Median Progression Free Survival (PFS)|Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression. PFS time measured in months.|Overall study (baseline to disease progression)|Six participants were not evaluable for outcome assessment.||months||Full Range|Median
734949|NCT00429182|Primary|Number of Participants With Reduction in CTCs Following High-dose Chemotherapy With Purged Autologous Stem Cell Products|Number of circulating tumor cells (CTCs) measured at one month post autologous hematopoietic stem cell transplantation (AHST), considered both as longitudinal values and compared to the baseline number of CTCs.|Baseline to 1 month post AHST|Twenty-one participants provided blood samples for the enumeration of CTCs, before apheresis (baseline) and at one month after AHST.||participants|||Number
734950|NCT00429273|Primary|ADHD IV Rating Scale (Attention Deficit Hyperactivity Disorder Rating Scale)|"The primary clinical efficacy variable for treatment was the ADHD-RS-IV Total Score and two sub-scales (Inattentive and Hyperactive-Impulsive ).
The rating scale has 18 questions with answer options: None (0), Mild (1), Moderate (2) and Severe (3).
Scores are obtained by summing each item; The higher the score, the worse the outcome.
Total score range: 0-54 Total Inattentive score range: 0-27 Total Hyperactive/Impulsive score range: 0-27"|Measured at baseline Week 4 and Week 8|Every contrast includes estimates of maturation/time trend and the within subject covariance structure based on all participants using full information maximum likelihood estimation.||units on a scale||Standard Error|Least Squares Mean
734951|NCT00429299|Secondary|Number of Variations/Somatic Mutation in PI3KCA at Baseline|Analysis of mutations in the PI3KCA gene was performed from RNA extracted from frozen tumor tissue samples (sections). A gene is either a wild-type (no mutation) or mutated (presence of a mutation). Exons 9 and 20 of the PI3KCA gene were accessed (high frequency mutation at these two spots).|Baseline|ITT Population. Only those participants for which high-quality tumor tissue samples were available were analyzed.||Variations/Somatic mutations|||Number
734952|NCT00429299|Secondary|Number of Participants With Any Adverse Event (AE), Including Serious Adverse Events (SAEs), Occurring in >=5% of Participants|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment had been exercised in deciding whether reporting was appropriate in other situations.|From the first dose of randomized therapy to 30 days after the last dose of randomized therapy (assessed up to Study Week 29)|Safety Population: all randomized participants||Participants|||Number
734953|NCT00429299|Secondary|Percentage of Inhibition of Biomarkers Ki67, pAKT, pMAPK, Tunel Test, PTEN, and pEGFR After Treatment|The percentage of inhibition of intermediate (EGFR, HER2, pMAPK, pAKT, PTEN, and PI3KCA) and final (TUNEL and Ki67) biomarkers of the proliferation and apoptosis pathways was calculated as the difference between the staining scores before (Baseline [biopsy]) and after treatment (withdrawal).|At Baseline and Withdrawal (assessed up to Study Week 29)|ITT Population. Only those participants contributing data to the indicated time points were analyzed.||Percentage of inhibition||Full Range|Median
734954|NCT00429299|Secondary|Number of Participants With Treatment Failure|Treatment failure is defined as the occurrence of local tumor progression (including ipsilateral and controlateral breast), distant tumor progression, permanent treatment discontinuation (either for the experimental or conventional arm), or death due to any cause.|From randomization up to 29 weeks|ITT Population||Participants|||Number
734970|NCT00429364|Secondary|Annual Rate of Change in Arm Span to Height Ratio||Up to 3 years following randomization.|All randomized participants whose arm span to height ratios were measured at baseline and at any of the follow-up visits.||1/year||Standard Error|Least Squares Mean
734971|NCT00429364|Secondary|Annual Rate of Change in Body Mass Index for Age Z-score||Up to 3 years following randomization.|All randomized participants who were between 0-20 years of age and whose body mass index for age z-scores were measured at baseline and at any of the follow-up visits.||z-score/year||Standard Error|Least Squares Mean
734955|NCT00429299|Secondary|Time to Treatment Failure From the Start of Primary Therapy|Time to treatment failure (TTF) is defined as the interval of time between the date of randomization and the earliest date of disease progression, premature treatment discontinuation and death due to any cause. The overall disease progression date is the earlier of the two disease progression dates from ultrasonography and mammography assessments. For ultrasonography, disease progression is defined as at least 20% increase in the longest diameter of the primary lesion at pre-surgery comparing to Baseline. For mammography, disease progression is defined as at least 20% increase in the larger nodule dimension at pre-surgery comparing to Baseline. For participants who has neither progressed, pre-maturely withdrawn or died, time to treatment failure will be censored at the latest date of ultrasonography and mammography tumor assessments.|From randomization up to Study Week 307|ITT Population: all participants who were randomized||Months||95% Confidence Interval|Median
734956|NCT00429299|Secondary|Percentage of Participants Who Had Breast-conserving Surgery (BCS), Mastectomy, and Conversion From Mastectomy to BCS|The percentage of participants who had BCS and mastectomy and who were initiallycandidates for mastectomy and who actually had BCS was measured. At Baseline, the surgeon stated, within 4 weeks before starting the primary treatment, which type of surgical treatment he would perform in the absence of primary therapy and in the case of primary therapy (if the tumor size was reduced by the primary treatment to less than 3 centimeters), and the reasons for these choices. The rules for choosing the type of surgical treatment are reported in the Consensus Conference on Primary Treatment of Early Breast Cancer. The surgeon was to have re-evaluated the participant after primary treatment. In cases in which the type of surgical procedure was different from that originally programmed, the reason for this chance was to have been reported.|At Baseline and at surgery (up to Study Week 29)|Efficacy Analysis Population||Percentage of participants|||Number
734957|NCT00429299|Secondary|Percentage of Participants With the Indicated Clinical Objective Response (Complete Response and Partial Response), Stable Disease, and Progressive Disease, as Assessed by Ultrasonography|The clinical response was evaluated by comparing the tumor size (largest tumor diameter) before (at Baseline [biopsy]) and after treatment (before surgery), as assessed by ultrasonography examination. The clinical response was scored by Response Evaluation Criteria in Solid Tumors (RECIST) as follows: complete clinical response: the nodule is not detectable and all the ultrasound abnormality detected at diagnosis disappeared (margins circumscribed, round oval shape, parallel orientation, isoechoic echo pattern, no posterior acoustic features, echogenic lesion boundary, and tumor vascularity not present); partial clinical response: the longest diameter of the tumor has been reduced by >50%, and the ultrasound characteristics of the tumor persist; no response (stable disease): the longest diameter of the tumor has been reduced by <50% or has increased by no more than 20% from the starting value; progressive disease: tumor longest diameter has increased >20% from the starting value.|At Baseline and after primary treatment (within 2 weeks before surgery; up to Study Week 27)|Efficacy Analysis Population||Percentage of participants|||Number
734958|NCT00429299|Primary|Percentage of Participants With Pathological Complete Response (pCR) in the Breast and in the Lymph Nodes|Pathological Complete Response (pCR) is defined by the complete absence of infiltrating tumor cells in the breast and in the lymph nodes. The pathological response in the breast was evaluated according to the criteria of Miller and Payne as follows: Grade 1, no change or some alteration to individual malignant cells, but no reduction in overall cellularity; Grade 2, a minor loss in tumor cells (up to 30%); Grade 3, between an estimated 30% and 90% reduction in tumor cells; Grade 4, marked disappearance of tumor cells, with only a small cluster or a dispersed cell remaining (more than 90% loss); Grade 5, no identifiable malignant cells. Ductal carcinoma in situ (DCIS) may be present. Grades were interpreted as follows: Grade 1-2=no response; Grade 3-4=partial response; Grade 5=complete response. pCR was defined by comparing specimens obtained at Baseline (biopsy) to those obtained upon surgery.|At Baseline and surgery (within 5 weeks after the last chemotherapy administration) (assessed up to Study Week 29)|Efficacy Analysis Population: all participants in the Intent-to-Treat Population (all participants who were randomized), except for the 2 participants who were excluded because of withdraw of consent and major protocol deviation||Percentage of participants|||Number
734959|NCT00429364|Secondary|Adverse Drug Reactions Reported During Routine Follow-up Surveillance||From 6 months to 3 years following randomization.|All subjects who had any of the follow-up visits after 6 months post-randomization.||participants|||Number
734960|NCT00429364|Secondary|Adverse Drug Reactions Reported at the Baseline Visit||At baseline|All randomized participants.||participants|||Number
734961|NCT00429364|Secondary|Event Rate of the Composite Adverse Clinical Outcomes, Including Aortic Dissection, Aortic-root Surgery and Death.|Percentage of participants who had aortic dissection, aortic-root surgery or death over a 3-year period following randomization|Up to 3 years following randomization.|All randomized participants who received the treatment||Percentage of participants||95% Confidence Interval|Number
734962|NCT00429364|Secondary|Number of Participants With the Composite Adverse Clinical Outcomes, Including Aortic Dissection, Aortic-root Surgery and Death.||Up to 3 years following randomization.|All randomized participants who received the treatment||participants|||Number
734963|NCT00429364|Secondary|Event Rate of Death|Percentage of participants who died over a 3-year period following randomization.|Up to 3 years following randomization.|All randomized participants who received the treatment||Percentage of participants||95% Confidence Interval|Number
734964|NCT00429364|Secondary|Number of Death.||Up to 3 years following randomization.|All randomized participants who received the treatment||participants|||Number
734965|NCT00429364|Secondary|Event Rate of Aortic-Root Surgery|Percentage of participants who had aortic-root surgery over a 3-year period following randomization.|Up to 3 years following randomization.|All randomized participants who received the treatment||Percentage of participants||95% Confidence Interval|Number
734966|NCT00429364|Secondary|Number of Participants With Aortic-root Surgery.||Up to 3 years following randomization.|All randomized participants who received the treatment||participants|||Number
734967|NCT00429364|Secondary|Event Rate of Aortic Dissection.|Percentage of participants who had aortic dissection over a 3-year period following randomization.|Up to 3 years following randomization.|All randomized participants who received the treatment||Percentage of participants||95% Confidence Interval|Number
734968|NCT00429364|Secondary|Number of Participants With Aortic Dissection.||Up to 3 years following randomization.|All randomized participants who received the treatment||participants|||Number
734975|NCT00429364|Secondary|Annual Rate of Change in Weight-for-height Z-score||Up to 3 years following randomization.|All randomized participants who were <120 cm in heights and whose weight-for-height z-scores were measured at baseline or at any of the follow-up visits.||z-score/year||Standard Error|Least Squares Mean
734976|NCT00429364|Secondary|Annual Rate of Change in Weight-for-age Z-score||Up to 3 years following randomization.|All randomized participants who were between 0-20 years of age and whose weight-for-age z-scores were measured at baseline and at any of the follow-up visits.||z-score/year||Standard Error|Least Squares Mean
734977|NCT00429364|Secondary|Annual Rate of Change in Weight||Up to 3 years following randomization.|||kg/year||Standard Error|Least Squares Mean
734978|NCT00429364|Secondary|Annual Rate of Change in Total Aortic Proximal Regurgitant Jet Area Indexed to Body-surface-area||Up to 3 years following randomization.|All randomized participants whose total aortic proximal regurgitant jet area indexes were measured at baseline or at any of the follow-up visits.||(mm^2/m^2)/year||Standard Error|Least Squares Mean
734979|NCT00429364|Secondary|Annual Rate of Change in the Absolute Diameter of the Aortic Annulus||Up to 3 years following randomization.|All randomized participants whose absolute dimensions of the aortic annulus were measured at baseline and at any of the follow-up visits.||cm/year||Standard Error|Least Squares Mean
734980|NCT00429364|Secondary|Annual Rate of Change in Aortic-annulus-diameter Z Score, Adjusted by Body-surface Area||Up to 3 years following randomization.|All randomized participants whose aortic-annulus-diameter z scores were measured at baseline and at any of the follow-up visits.||z-score/year||Standard Error|Least Squares Mean
734981|NCT00429364|Secondary|Annual Rate of Change in the Absolute Diameter of the Ascending Aorta||Up to 3 years following randomization.|All randomized participants whose absolute dimensions of the ascending aorta were measured at baseline and at any of the follow-up visits.||cm/year||Standard Error|Least Squares Mean
734982|NCT00429364|Secondary|Annual Rate of Change in Ascending-aorta-diameter Z Score, Adjusted by Body-surface-area.||Up to 3 years following randomization.|All randomized participants whose ascending-aorta-diameter z scores were measured at baseline and at any of the follow-up visits.||z-score/year||Standard Error|Least Squares Mean
734983|NCT00429364|Secondary|Annual Rate of Change in Aortic Root (Sinuses of Valsalva) Absolute Dimension|The rate of change in the absolute dimension of the aortic root over a 3-year period following randomization|Up to 3 years following randomization.|||cm/year||Standard Error|Least Squares Mean
734984|NCT00429364|Primary|Annual Rate of Change in Aortic Root (Sinuses of Valsalva) Body-surface-area-adjusted Z-score|The rate of aortic root enlargement, expressed as the annual change in the maximum aortic-root-diameter z score indexed to body-surface area over a 3-year period following randomization|Up to 3 years following randomization.|||z-score/year||Standard Error|Least Squares Mean
734985|NCT00429403|Primary|Number of Patients With Response (FSH Level + Vaginal Bleeding)|Outcome characterized in terms of two variables, each measured repeatedly over time: Follicle-stimulating hormone (FSH) level and whether vaginal bleeding occurs, each to be measured from the end of chemotherapy. For treatment comparison, “response” defined as a composite event: both [FSH < 15] and vaginal bleeding observed within 12 months after the end of chemotherapy, with both FSH and vaginal bleeding baseline observed before start of chemotherapy.|Baseline prior to chemotherapy then every 3 months after chemotherapy for 1 year|Analysis was per protocol. Limited analysis due to low recruitment and early termination.||participants|||Number
734986|NCT00429416|Secondary|Number of Patients Who Achieve a CD4 Count > 200/Micro-liters|Determine the number of patients who achieve a CD4 count > 200/micro-liters by 60 days after transplant.|Through 60 Days Post Transplant|||participants|||Number
734987|NCT00429416|Secondary|Rate of Serious Infectious Complications|"Determine the rate of serious infectious complications. A serious infection will be defined as any requiring hospitalization or parenteral therapy.
CD4 counts will be measured monthly for the first 3 months after transplant."|Through 3 months post-transplant|||participants|||Number
734988|NCT00429416|Secondary|Incidence of Grade II-IV Acute Graft-Versus-Host-Disease (GVHD)|Determine the incidence of grade II-IV acute GVHD after administration of grafts when combined with Cyclosporine/Mycophenolate Mofetil for GVHD prophylaxis. GVHD assessments occur daily as an in patient and at each out patient visit.|Through 24 months post-treatment|||participants|||Number
734989|NCT00429416|Secondary|Rate of Engraftment of Non-Myeloablative Transplants|Determine the engraftment rate of non-myeloablative transplants using CD34+ stem cells and LLME treated CD34- products.|Through 30 days post-transplant|||participants|||Number
734990|NCT00429416|Primary|Safety of CD34+ Stem Cell Infusions Followed by LLME as Measured by 100-Day Mortality|"Determine the safety of CD34+ stem cell infusions followed by the LLME treated CD34- fraction. This includes monitoring the patients for any side effects associated with the LLME treated cell infusion or any other unexpected adverse events.
This regimen will be gauged as to its safety using 100 day mortality as the measured endpoint. Deaths from all causes will be included."|Through 100 days post-transplant or death|||participants|||Number
734991|NCT00429494|Primary|Number of Participants With Secondary Amenorrhea Following 3-month Depot Leuprolide|Hormonal profile blood tests including follicle-stimulating hormone (FSH) test, luteinizing hormone (LH) and estradiol levels done every two months with menstruation questionnaire, starting three months after the injection of the second dose of leuprolide until the restoration of spontaneous menstruation or the presence of ovarian failure. Any unexpected vaginal bleeding or side effects during the period covered by leuprolide injection, which is 6 months, is recorded by participants in a monitoring checklist sheet given to them.|6 months|Of the 59 patients who underwent HSCT, nine patients refused the second dose of leuprolide and were subsequently taken off study. Six patients died of either disease progression or transplantation-related complications before their ovarian function status was evaluated.||participants|||Number
734992|NCT00429507|Primary|Time to Progression|Time to progression is measured as the time from study entry to the development of disease progression.|7.5 Years, Study period was March 2007 to November 2014.|||Days||Full Range|Median
735047|NCT00423046|Secondary|Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA)|Other oncogenic types include HPV-31 and HPV-45. Cut-off values assessed were greater than or equal 59 EL.U/mL in the sera of subjects seronegative before vaccination.|At Month 6, 7, 12, 18, 24, 36 and 48|Analysis was performed by age group on subjects from the ATP cohort for immunogenicity who were seronegative (by ELISA) and DNA negative for the corresponding type at baseline.||subjects|||Number
734993|NCT00429572|Primary|Number of Participants With Acute or Chronic GVHD And Response to Therapy|"Participants diagnosed with Graft versus Host Disease (GVHD) post transplant were divided into either acute (aGVHD), normally observed within the first 100 days post-transplant; and chronic GVHD (cGVHD) cases, normally occur after 100 days, then evaluated and scored according to standard criteria from Consensus conference on acute GVHD grading, Bone Marrow Transplant 1995; 15: 825-828, noted is type of case and whether responds to therapy."|Transplant to 1 year post transplant|As treated: Eighteen received the allogeneic transplantation.||participants|||Number
734994|NCT00429572|Primary|Grade II-IV Toxicity|Non-hematopoietic toxicity within the first year of transplantation, acute Graft versus Host Disease (GVHD) above National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade I and chronic above Grade I are reported by participant incidence. Broad classification of adverse events (AE) categories based on anatomy and/or pathophysiology; within each category, AEs are listed accompanied by their descriptions of severity (Grade, Grade 1 least severe).|Up to one year.|As treated: Eighteen received the allogeneic transplantation.||Participants|||Number
734995|NCT00429572|Primary|Time to Progressive Disease|Progression-free was measured, by days, at time from transplantation to development to disease or death from any cause, which ever occurred first.|Transplant to Progression.|||Days||Full Range|Median
734996|NCT00429572|Primary|Overall Survival|Survival duration was calculated from time of transplantation by number of days.|Transplant until death.|As treated: Eighteen received the allogeneic transplantation.||Days||Full Range|Median
734997|NCT00429572|Primary|Number of Participants With Tumor Response|Best response recorded from start of treatment until disease progression/recurrence using World Health Organization (WHO) criteria of Complete Response: disappearance of all disease/symptoms > 4 weeks; Partial response, > 50% reduction in sum of products of diameters of each measurable lesion for more than 4 weeks; Stable Disease, no change in tumor size; and Progressive Disease, appearance of new lesions or > 25% increase in sum of products of diameters of any measurable lesions.|Baseline to measured progressive disease (post study follow-up period 24 months starting from the date of the last drug administration). Data collected every 4 months.|As treated: Eighteen received the allogeneic transplantation.||participants|||Number
734998|NCT00417417|Other Pre-specified|Brachial Artery Flow-mediated Dilation|Brachial artery flow-mediated dilation in respone to 5 minutes of forearm ischemia|Two weeks following final administration of drug|Per protocol||percent change||Standard Deviation|Mean
734999|NCT00417417|Primary|C-Reactive Protein (CRP)|C-reactive protein levels in subjects randomized to rilonacept versus placebo injections.|2 wks following last drug administration|per protocol||mg/L||Standard Deviation|Mean
735000|NCT00422903|Secondary|Time to Treatment Failure From the Start of the Primary Therapy|Time to treatment failure is calculated as the interval between the date of randomization and the occurrence of local tumor progression (including ipsilateral [on the same side] and controlateral breast tumor progression), distant tumor progression, permanent treatment discontinuation (either for the experimental or conventional treatment arm), or death for any cause.|From Baseline (Day 1) up to study withdrawal (approx. 66 months)|ITT Population. Only those participants contributing data were analyzed.||Months||95% Confidence Interval|Median
735001|NCT00422903|Secondary|Mean Left Ventricular Ejection Fraction (LVEF)|Cardiac safety was evaluated as any signs or symptoms of deterioration in LVEF. LVEF is the measurement of how much blood is being pumped out of the left ventricle of the heart (the main pumping chamber) with each contraction. LVEF was evaluated using NCI CTCAE.|Baseline (Day 1), after 12 weeks, and after 24 weeks|ITT Population. Only those participants contributing data were analyzed.||Percent volume||Full Range|Mean
735002|NCT00422903|Secondary|Number of Participants With the Indicated Adverse Events With a Classification of >=Grade 2|Toxicity was measured in grades (severity of the AE) as per National Cancer Institute Common Toxicity Criteria for Adverse Event (NCI CTCAE) version (v) 3.0. The CTCAE v3.0 displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening/disabling; Grade 5, death related to the AE. Mucositis is the painful inflammation and ulceration of the mucous membranes lining the digestive tract, and hypertension is high blood pressure.|From Baseline (Day 1) up to 6 months (until definitive surgery)|ITT Population. Only those participants contributing data were analyzed.||participants|||Number
735003|NCT00422903|Secondary|Percentage of Participants With Conversion From Planned Mastectomy at Baseline to BCS at Surgery|The percentage of participants who were planned to undergo a mastectomy at baseline but later underwent BCS was measured.|At the point of definitive surgery (up to 6 months after Baseline)|ITT Population. Only those participants contributing data were analyzed.||percentage of participants|||Number
735004|NCT00422903|Secondary|Number of Participants With the Indicated Type of Surgery|Mastectomy is the medical term for the surgical removal of one or both breasts. Breast-conserving surgery (BCS) involves removing only the affected part of the breast tissue during surgery, as opposed to removal of the entire breast.|At the point of definitive surgery (up to 6 months after Baseline 1)|ITT Population. Only those participants contributing data were analyzed.||participants|||Number
735005|NCT00422903|Secondary|Number of Participants With the Indicated Nodal Status at Surgery|The nodal status of cancer indicates the involvement of lymph nodes in the participant with cancer. N0 indicates no involvement of lymph nodes, and N+ indicates involvement of lymph nodes.|At the point of definitive surgery (up to 6 months after Baseline)|ITT Population. Only those participants contributing data were analyzed.||participants|||Number
735006|NCT00422903|Secondary|Number of Participants With Breast Tumors Per Pathological Stage at Surgery|Tumors were categorized as follows: T0, no evidence of primary tumor, but carcinoma of the milk ducts, accumulation of abnormal cells in the breast lobules, or Paget disease (cancer condition that appears like a skin disease involving the breast nipple) with no associated tumor mass; T1, tumor was <=2 centimeters (cm) across; T2, tumor was >2 cm but <5 cm across; T3, tumor was >5 cm across; T4, tumor of any size growing into the chest wall or skin, including inflammatory breast cancer.|At the point of definitive surgery (up to 6 months after Baseline)|ITT Population. Only those participants contributing data were analyzed.||participants|||Number
735114|NCT00423332|Secondary|Best Percentage Change From Baseline in Tumour Size During the Study|Maximum reduction or minimum increase in tumour size where size is the sum of the longest diameters of the target lesions|Treatment period up to Week 12 visit date for last patient in (LPI)|For patients to be included in the analysis they had to have been evaluable for RECIST with week 12 or progression tumour size data.||Percentage change from baseline||Standard Deviation|Mean
735007|NCT00422903|Secondary|Percentage of Participants With Pathological Complete Response (pCR) in the Breast and Axillary Nodes, Evaluated Using Miller and Payne Criteria|pCR is defined as the complete absence of infiltrating tumor cells (TCs) in the breast and lymph nodes. Miller and Payne criteria: Grade 1, no change/some alteration to individual malignant cells, but no reduction in overall cellularity; Grade 2, up to a 30% loss in TCs; Grade 3, between an estimated 30% and 90% reduction in TCs; Grade 4, more than a 90% reduction in TCs, only small cluster/dispersed cells remaining; Grade 5, no malignant identifiable cells; carcinoma in the milk ducts may be present. Grades 1 and 2 = No response; Grades 3 and 4= PR; Grade 5 = CR.|At the point of definitive surgery (up to 6 months after Baseline)|ITT Population||Percentage of participants||95% Confidence Interval|Number
735008|NCT00422903|Primary|Percentage of Participants With Various Responses in the Breast, Evaluated Using Per Protocol Criteria|Complete clinical response=nodule not detectable; all ultrasound abnormalities detected at diagnosis have disappeared. Partial clinical response=the tumor's longest diameter (LD) is reduced by 50% or more; ultrasound characteristics of the tumor persist. Minimal response=the tumor's LD is reduced by 25%-49%. Stable disease=the tumor's LD is decreased by less than 25% and is increased by no more than 25% from the starting value. Progressive disease=the tumor's LD is increased by more than 25% from the starting value. Participants who were not evaluable did not have data available.|From Baseline (Day 1) up to 6 months, evaluated every 12 weeks|ITT Population. Three participants withdrew consent and were not included in the efficacy analysis.||percentage of participants|||Number
735009|NCT00422903|Primary|Percentage of Participants With Clinical Objective Response (cOR) in the Breast, Evaluated by an Independent Radiological Evaluation Monitoring Committee|cOR is defined as the documented evidence of complete response (CR) and partial response (PR) as assessed by ultrasound examination using Response Evaluation Criteria In Solid Tumors (RECIST). CR is defined as the disappearance of all target lesions (TLs) and non-TLs and the appearance of no new lesions (NLs). PR for TLs is defined as a >=30% decrease in the sum of the longest diameter (LD) of TLs, taking as a reference the Baseline sum LD. For non-TLs, it is defined as the persistence of >=1 non-TL and no new TLs or non-TLs.|From Baseline (Day 1) up to 6 months, evaluated every 12 weeks|Intent-to-Treat (ITT) Population: all participants who entered the study and received at least one dose of letrozole. Three participants withdrew consent and were not included in the efficacy analysis.||percentage of participants|||Number
735010|NCT00422942|Primary|Change From Baseline in Absolute B Cell CD19+ Counts in Peripheral Blood|The change from baseline in absolute B cell (CD19+) count at each visit calculated as (B cell count at visit minus B cell count at baseline) for peripheral blood.|Weeks 4, 12, 24, 36, and 48|No participant data were analyzed. Study was terminated after enrollment of 3 participants as it was decided that it would not be appropriate to expose further participants to study drug since the objectives and data sought from this study had been published from other, independent sources and given the recruitment difficulties encountered.|||||
735011|NCT00422942|Secondary|Change From Baseline in Joint Space Narrowing (JSN) Score|Changes from baseline in modified Sharp radiographic JSN score from baseline to Weeks 24 and 48. The change in score at week X (where X=Week 24 or Week 48, as appropriate) calculated as: Change = week X score minus screening score.|Weeks 24 and 48|No participant data were analyzed. Study was terminated after enrollment of 3 participants as it was decided that it would not be appropriate to expose further participants to study drug since the objectives and data sought from this study had been published from other, independent sources and given the recruitment difficulties encountered.|||||
735012|NCT00422942|Secondary|Change From Baseline in Erosion Score|Changes from baseline in modified Sharp radiographic erosion score from baseline to Weeks 24 and 48. The change in score at week X (where X=Week 24 or Week 48, as appropriate) calculated as: Change = week X score minus screening score.|Weeks 24 and 48|No participant data were analyzed. Study was terminated after enrollment of 3 participants as it was decided that it would not be appropriate to expose further participants to study drug since the objectives and data sought from this study had been published from other, independent sources and given the recruitment difficulties encountered.|||||
735013|NCT00422942|Secondary|Change From Baseline in Modified Total Sharp Score (mTSS)|mTSS = sum of erosion and Joint Space Narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change: scores at observation minus score at baseline. An increase in mTSS from baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Weeks 24 and 48|No participant data were analyzed. Study was terminated after enrollment of 3 participants as it was decided that it would not be appropriate to expose further participants to study drug since the objectives and data sought from this study had been published from other, independent sources and given the recruitment difficulties encountered.|||||
735014|NCT00422942|Secondary|Change From Baseline in ACR Core Set|The changes from baseline in the ACR core set parameters at Week 48. Change from baseline to Week 48 over time in ACR core set: SJC, TJC, physician's global assessment of disease activity, patient's global assessment of disease activity, patient's assessment of pain, HAQ, ESR, and CRP. ACR20/50/70 response: ≥20%/50%/70% improvement in SJC; ≥20%/50%/70% improvement in TJC; and ≥20%/50%/70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; physician's global assessment of disease activity, participant's assessment of disease activity, participant assessment of functional disability via a HAQ, and CRP at each visit.|Week 48|No participant data were analyzed. Study was terminated after enrollment of 3 participants as it was decided that it would not be appropriate to expose further participants to study drug since the objectives and data sought from this study had been published from other, independent sources and given the recruitment difficulties encountered.|||||
735015|NCT00422942|Secondary|Percentage of Participants Achieving Response by European League Against Rheumatism (EULAR) Category|The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 ≤ 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to ≤ 5.1 or change from baseline >0.6 to ≤ 1.2 with DAS28 ≤ 5.1; non-responders: change from baseline ≤ 0.6 or change from baseline >0.6 and ≤ 1.2 with DAS28 >5.1.|Weeks 24, 36, and 48|No participant data were analyzed. Study was terminated after enrollment of 3 participants as it was decided that it would not be appropriate to expose further participants to study drug since the objectives and data sought from this study had been published from other, independent sources and given the recruitment difficulties encountered.|||||
735016|NCT00422942|Secondary|Change From Baseline in Disease Activity Score Based on 28 Joint Count (DAS28) Erythrocyte Sedimentation Rate (ESR) Score|The change in DAS28-ESR at Weeks 12, 24, 36, and 48, relative to baseline. DAS28-ESR was calculated from SJC and TJC using 28-joint count, ESR (millimeters per hour [mm/hour]) and patient global assessment of disease activity (participant-rated arthritis activity assessment). Total score range: 0-9.4, higher score equals (=) more disease activity. DAS28-ESR less than or equal to (≤) 3.2 implied low disease activity and greater than (>)3.2 to 5.1 implied moderate to high disease activity, and DAS28-ESR <2.6 = remission.|Weeks 12, 24, 36, and 48|No participant data were analyzed. Study was terminated after enrollment of 3 participants as it was decided that it would not be appropriate to expose further participants to study drug since the objectives and data sought from this study had been published from other, independent sources and given the recruitment difficulties encountered.|||||
735017|NCT00422942|Secondary|Percentage of Participants Achieving American College of Rheumatology 20 Percent (20%) 50%, and 70% (ACR20/50/70) Response|ACR20/50/70 response is greater than or equal to (≥) 20%, 50%, or 70% improvement, respectively, in tender joint count (TJC) and swollen joint count (SJC); and improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Week 48|No participant data were analyzed. Study was terminated after enrollment of 3 participants as it was decided that it would not be appropriate to expose further participants to study drug since the objectives and data sought from this study had been published from other, independent sources and given the recruitment difficulties encountered.|||||
735018|NCT00422942|Secondary|Change From Baseline in Myelocytomatosis Oncogene (C-myc) and BCL2-associated X Protein (BAX) in Peripheral Blood|The change in ribonucleic acid (RNA) expression of markers of apoptosis (C-myc and BAX) in peripheral blood at Days 15 and 183, relative to baseline.|Days 15 and 183|No participant data were analyzed. Study was terminated after enrollment of 3 participants as it was decided that it would not be appropriate to expose further participants to study drug since the objectives and data sought from this study had been published from other, independent sources and given the recruitment difficulties encountered.|||||
735019|NCT00422942|Secondary|Change From Baseline in Levels of Key Cytokines in (IL-1β, TNF-α, IL-6, and IL-10) in Synovial Tissues|The change in levels of key cytokines in (IL-1β, TNF-α, IL-6, and IL-10) in synovial tissues at Weeks 12, 24, and 36, relative to baseline.|Weeks 12, 24, and 36|No participant data were analyzed. Study was terminated after enrollment of 3 participants as it was decided that it would not be appropriate to expose further participants to study drug since the objectives and data sought from this study had been published from other, independent sources and given the recruitment difficulties encountered.|||||
735020|NCT00422942|Secondary|Change From Baseline in Levels of Key Cytokines (Interleukin [IL]-1beta [β], Tumor Necrosis Factor [TNF]-Alpha [α], IL-4, IL-6, IL-10, and IL-13) in Blood (Serum)|The change in levels of key cytokines (IL-1β, TNF-α, IL-4, IL-6, IL-10, and IL-13) in blood (serum) on Days 15 and 183 and at Weeks 4, 12, 24, 36, and 48, relative to baseline.|Days 15 and 183 and Weeks 4, 12, 24, 36, and 48|No participant data were analyzed. Study was terminated after enrollment of 3 participants as it was decided that it would not be appropriate to expose further participants to study drug since the objectives and data sought from this study had been published from other, independent sources and given the recruitment difficulties encountered.|||||
735021|NCT00422942|Secondary|Change From Baseline in Absolute Counts of Cells Expressing CD20+ and CD22+ in Absolute B Cell (CD19+) Counts in Peripheral Blood|The change in absolute counts of cells expressing the key B cell markers (CD20+ and CD22+) in absolute B cell (CD19+) counts in peripheral blood at Weeks 4,12, 24, 36, and 48, relative to baseline.|Weeks 4,12, 24, 36, and 48|No participant data were analyzed. Study was terminated after enrollment of 3 participants as it was decided that it would not be appropriate to expose further participants to study drug since the objectives and data sought from this study had been published from other, independent sources and given the recruitment difficulties encountered.|||||
735022|NCT00422942|Secondary|Change From Baseline in Absolute Counts of Cells Expressing CD20+ and CD22+ in Absolute B Cell (CD19+) Counts in Synovial Tissues|The change in absolute counts of cells expressing the key B cell markers (CD20+ and CD22+) in absolute B cell (CD19+) counts in synovial tissues at Weeks 12, 24, and 36, relative to baseline.|Weeks 12, 24, and 36|No participant data were analyzed. Study was terminated after enrollment of 3 participants as it was decided that it would not be appropriate to expose further participants to study drug since the objectives and data sought from this study had been published from other, independent sources and given the recruitment difficulties encountered.|||||
735023|NCT00422942|Primary|Change From Baseline in Absolute B Cell Cluster Differential 19 Positive (CD19+) Counts in Synovial Tissues|The change from baseline in absolute B cell (CD19+) counts at each visit calculated as (B cell count at visit minus B cell count at baseline) for synovial tissues.|Weeks 12, 24, and 36|No participant data were analyzed. Study was terminated after enrollment of 3 participants as it was decided that it would not be appropriate to expose further participants to study drug since the objectives and data sought from this study had been published from other, independent sources and given the recruitment difficulties encountered.|||||
735024|NCT00423046|Secondary|Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)|"SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related SAE = SAE assessed by the investigator as causally related to the study vaccination. Intensity of SAE(s) was not assessed.
Note: SAEs were unblinded at the Month 60 analysis."|Up to Month 60|Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.||subjects|||Number
735025|NCT00423046|Secondary|Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related SAE = SAE assessed by the investigator as causally related to the study vaccination. Intensity of SAEs was not assessed.|Up to Month 48|Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.||subjects|||Number
735026|NCT00423046|Secondary|Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related SAE = SAE assessed by the investigator as causally related to the study vaccination. Intensity of SAEs was not assessed.|Up to Month 36|Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.||Subjects|||Number
735027|NCT00423046|Secondary|Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related SAE = SAE assessed by the investigator as causally related to the study vaccination. Intensity of SAEs was not assessed.|Up to Month 24|Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.||Subjects|||Number
735028|NCT00423046|Secondary|Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related SAE = SAE assessed by the investigator as causally related to the study vaccination. Intensity of SAEs was not assessed.|Up to Month 18|Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.||Subjects|||Number
735029|NCT00423046|Secondary|Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related SAE = SAE assessed by the investigator as causally related to the study vaccination. Intensity of SAEs was not assessed.|Up to Month 12|Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.||Subjetcs|||Number
735030|NCT00423046|Secondary|Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related SAE = SAE assessed by the investigator as causally related to the study vaccination. Intensity of SAEs was not assessed.|Up to Month 7|Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.||Subjects|||Number
735031|NCT00423046|Secondary|Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs)|"NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. MSCs include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
Note: NOCD and MSC cases were unblinded at the Month 60 analysis."|Up to Month 60|Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.||subjects|||Number
735032|NCT00423046|Secondary|Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs)|NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. MSCs include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|Up to Month 48|Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.||subjects|||Number
735033|NCT00423046|Secondary|Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs)|NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. MSC include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|Up To Month 36|Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.||Subjects|||Number
735034|NCT00423046|Secondary|Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs)|NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. MSC include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|Up To Month 24|Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.||Subjects|||Number
735035|NCT00423046|Secondary|Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs)|NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. MSC include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|Up To Month 18|Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.||Subjects|||Number
735036|NCT00423046|Secondary|Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs)|NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. MSC include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|Up To Month 12|Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.||Subjects|||Number
735037|NCT00423046|Secondary|Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs)|NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. MSCs include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|Up to Month 7|Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.||Subjects|||Number
735038|NCT00423046|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.Grade 3 AE = AE that prevented normal activity. Related AE = AE assessed by the investigator as causally related to the study vaccination.|During the 30-day period (Day 0-29) following vaccination|Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.||subjects|||Number
735039|NCT00423046|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastrointestinal, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day period (Day 0-6) following vaccination|Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.||subjects|||Number
735040|NCT00423046|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. All solicited local symptoms were assessed as related to study vaccination.|During the 7-day period (Day 0-6) following vaccination|Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.||subjects|||Number
735041|NCT00423046|Secondary|Number of Subjects Completing the 3-dose Vaccination Schedule||Up to Month 7|The number of subjects completing the 3-dose vaccination schedule was defined as the number of subjects who received the 3 active doses (placebo administrations are not reflected).||subjects|||Number
735042|NCT00423046|Secondary|Titers of HPV-16 IgG and HPV-18 IgG (by ELISA) in Cervico-vaginal Secretions (CVS)|Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).|At Month 7, 12, 18, 24, 36 and 48|Analyses were done on those subjects from the ATP cohort for immunogenicity for whom CVS samples with less than 200 erythrocytes per microliter were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
735043|NCT00423046|Secondary|Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells|HPV-16 and HPV-18 Specific Memory B Cells were measured by Enzyme-linked immunosorbent spot (ELISPOT) assay and expressed as geometric mean, minimum and maximum values of specific B-cells per million of cells.|At Month 7, 12, 18, 24, 36 and 48|Results are presented by age group in subjects with detectable B-cells (>0) at defined time points, who were HPV-16/18 seronegative (by PSV neutralizing assay), DNA negative and HPV-16/18 specific B-cell negative at baseline from a subset of the ATP cohort for immunogenicity.||cells per million B-cells||Full Range|Geometric Mean
735044|NCT00423046|Secondary|Number of HPV-16 and HVP-18 Specific CD8 Cells Producing at Least 2 Different Cytokines Per Million of CD8 T Cells|"Data were expressed as geometric mean, minimum and maximum values of specific CD8 cells producing at least 2 cytokines (CD40 Ligand, Interleukin-2, Tumor Necrosis Factor Alpha or Interferon-gamma) per million of CD8 T-cells.
Analyses for further time points were not performed, as there was no response at these time points."|At Month 7, 12 and 18|Results are presented by age group for subjects HPV-16/18 seronegative (by PSV neutralizing assay), DNA negative and HPV-16/18 specific T-cell negative (i.e., with < 200 cells/million cells at baseline) from a subset of the ATP cohort for immunogenicity.||cells per million CD8 T-cells||Full Range|Geometric Mean
735045|NCT00423046|Secondary|Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells|Number of cells were expressed as geometric mean, minimum and maximum values of specific CD4 cells producing at least 2 cytokines (CD40 Ligand, Interleukin-2, Tumor Necrosis Factor Alpha or Interferon-gamma) per million of CD4 T-cells.|At Month 7, 12, 18, 24, 36 and 48|Results are presented by age group for subjects HPV-16/18 seronegative (by PSV neutralizing assay), DNA negative and HPV-16/18 specific T-cell negative (i.e., with < 500 cells/million cells at baseline) from a subset of the ATP cohort for immunogenicity.||cells per million CD4 T-cells||Full Range|Geometric Mean
735046|NCT00423046|Secondary|Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA)|Other oncogenic types include HPV-31 and HPV-45. Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).|At Month 6, 7, 12, 18, 24, 36 and 48|Analysis was performed by age group on subjects from the ATP cohort for immunogenicity who were seronegative (by ELISA) and DNA negative for the corresponding type at baseline.||EL.U/mL||95% Confidence Interval|Geometric Mean
736023|NCT00432458|Secondary|12-month Progression-free Survival (PFS)|PFS at 12 months is a dichotomized outcome indicating whether or not a participant was progression free (and alive) at 12 months from the date of randomization.|12 months|||participants|||Number
735048|NCT00423046|Secondary|Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA)|Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).|At Month 6, 7, 12, 18, 24, 36, 48 and 60|Analysis was performed by age group on subjects from the ATP cohort for immunogenicity who were seronegative (by ELISA) and DNA negative for the corresponding type at baseline.||EL.U/mL||95% Confidence Interval|Geometric Mean
735049|NCT00423046|Secondary|Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA)|Cut-off values assessed were greater than or equal to 8 ELISA units per milliliter (EL.U/mL) for HPV-16 and greater than or equal to 7 EL.U/mL for HPV-18.|At Month 6, 7, 12, 18, 24, 36, 48 and 60|Analysis was performed by age group on subjects from the ATP cohort for immunogenicity who were seronegative (by ELISA) and DNA negative for the corresponding type at baseline.||subjects|||Number
735050|NCT00423046|Secondary|Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value|The titer value (=serum dilution giving a 50 percent reduction of the signal compared to a control without serum) used as the cut-off for seroconversion was 40 for both HPV-16 and HPV-18.|At Month 6, 7, 12, 18, 24, 36, 48 and 60|Analysis was performed by age group on subjects from the According-to-Protocol (ATP) cohort for immunogenicity who were seronegative by Pseudovirion neutralizing assay and deoxyribonucleic acid (DNA) negative for the corresponding type at baseline.||subjects|||Number
735051|NCT00423046|Secondary|Titers of Antibodies to Other Oncogenic HPV Types Measured by Neutralization Assay|Other Oncogenic Types include HPV-31 and HPV-45. Titers were measured by neutralization assay and are given as Geometric Mean Titers (GMTs). The titer is the serum dilution giving a 50 percent reduction of the signal compared to a control without serum|At Month 7|Analysis was performed by age group on subjects from the According-to-Protocol (ATP) cohort for immunogenicity with titer greater than or equal to 40 ED50 and who were seronegative by Pseudovirion neutralizing assay and deoxyribonucleic acid (DNA) negative for the corresponding type at baseline.||titer||95% Confidence Interval|Geometric Mean
735052|NCT00423046|Secondary|Number of Subjects With Antibody Titers (Neutralizing Assay) Against Other Oncongenic HPV Types Greater Than or Equal to the Cut-off Value|Other oncogenic HPV types include HPV-31 and HPV-45. The titer value (=serum dilution giving a 50 percent reduction of the signal compared to a control without serum) used as the cut-off for seroconversion was 40 for both other oncogenic types HPV-31 and HPV-45.|At Month 7|Analysis was performed by age group on subjects from the According-to-Protocol (ATP) cohort for immunogenicity who were seronegative by Pseudovirion neutralizing assay and deoxyribonucleic acid (DNA) negative for the corresponding type at baseline.||subjects|||Number
735053|NCT00423046|Secondary|Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies|"Titers are given as Geometric Mean Titers (GMTs). Titer is the serum dilution giving a 50 percent reduction of the signal compared to a control without serum.
Data for Month 7 on subjects aged 18 to 26 years are given in the outcome above as a primary outcome measure."|At Month 6, 7, 12, 18, 24, 36, 48 and 60|Analysis was performed by age group on subjects from the According-to-Protocol (ATP) cohort for immunogenicity who were seronegative by Pseudovirion neutralizing assay and deoxyribonucleic acid (DNA) negative for the corresponding type at baseline.||Titer||95% Confidence Interval|Geometric Mean
735054|NCT00423046|Primary|Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies|Titers are displayed as Geometric Mean Titers (GMTs). The titer is the serum dilution giving a 50 percent reduction of the signal compared to a control without serum.|At Month 7|Analysis was performed on subjects from the According-to-Protocol (ATP) cohort for immunogenicity aged 18 to 26 years and who were seronegative by Pseudovirion (PSV) neutralizing assay and deoxyribonucleic acid (DNA) negative for the corresponding type at baseline.||titer||95% Confidence Interval|Geometric Mean
735055|NCT00423085|Secondary|Extension Phase: Change From Extension Phase Baseline to End of Extension in Modified Crichton Scale|The Modified Crichton Scale includes a total of seven items evaluated in eight grades that assess basic activities of daily living, communication functions, psychiatric symptoms and quality of life; the total score can range from 0 to 56, with a lower score indicating better function. A negative change score indicates an improvement from baseline.|Extension Phase Baseline and Week 52 of extension phase|Intent-to-treat population utilizing last observation carried forward.||units on a scale||Standard Deviation|Mean
735056|NCT00423085|Secondary|Extension Phase: Change From Extension Phase Baseline to End of Extension in CIBIC Plus-J Score Disability Assessment for Dementia (DAD)|The Disability Assessment for Dementia (DAD) was used to assess levels of difficulty in activities of daily living. The DAD is administered through an interview with the caregiver. A total score is obtained by adding the rating for each question and converting this to a total score out of 100 (%). Higher scores represent less disability in activities of daily living while lower scores indicate more dysfunction. A positive change score indicates an improvement from baseline.|Extension Phase Baseline and Week 52 of extension phase|Intent-to-treat population utilizing last observation carried forward.||units on a scale||Standard Deviation|Mean
735057|NCT00423085|Secondary|Extension Phase: Change From Extension Phase Baseline to End of Extension in Mini-Mental State Examination (MMSE)|The MMSE is a screening test for cognitive dysfunction. The test consists of five sections (orientation, registration, attention-calculation, recall, and language); the total score can range from 0 to 30, with a higher score indicating better function. A positive change score indicates improvement. This outcome measured the change in MMSE from the beginning of the open-label extension phase through to Week 52 of the extension phase.|Extension Phase Baseline and Week 52 of extension phase|Intent-to-treat population utilizing last observation carried forward. This population includes all patients who received at least one dose of open-label study medication and had at least one efficacy assessment on treatment in the open-label extension Phase.||units on a scale||Standard Deviation|Mean
735058|NCT00423085|Secondary|Change From Baseline in Mini-Mental State Examination (MMSE)|The MMSE is a screening test for cognitive dysfunction. The test consists of five sections (orientation, registration, attention-calculation, recall, and language); the total score can range from 0 to 30, with a higher score indicating better function. A positive change score indicates improvement from baseline.|Baseline and Week 24|Intent-to-treat population. Only patients with a valid baseline and post-baseline score were included.||units on a scale||Standard Deviation|Mean
735059|NCT00423085|Secondary|Change From Baseline in CIBIC Plus-J Score Mental Function Impairment Scale (MENFIS)|MENFIS was used to assess patient cognitive and psychiatric function, and evaluates core symptoms of dementia including cognitive, motivational and emotional aspects. The total score ranges from 0 to 78. The higher the score, the greater the functional deficit. A negative change score indicates an improvement from baseline.|Baseline and Week 24|Intent-to-treat population. Only patients with a valid baseline and post-baseline score were included.||units on a scale||Standard Deviation|Mean
735060|NCT00423085|Secondary|Change From Baseline in CIBIC Plus-J Score Behavioral Pathology in Alzheimer's Disease Rating Scale (Behave-AD)|BEHAVE-AD was used to assess patient behavior and psychiatric symptoms. It covers symptoms in seven categories: paranoid and delusional ideation, hallucinations, activity disturbances, diurnal rhythm disturbances, aggressiveness, affective disorders and anxieties, and phobias. Caregivers rate behavioral symptoms on a 0–3 scale. The total score can range from 0 to 66, with a lower score indicating better function. A negative change score indicates an improvement from baseline.|Baseline and Week 24|Intent-to-treat population. Only patients with a valid baseline and post-baseline score were included.||units on a scale||Standard Deviation|Mean
735061|NCT00423085|Secondary|Change From Baseline in CIBIC Plus-J Score Disability Assessment for Dementia (DAD)|The Disability Assessment for Dementia (DAD) was used to assess levels of difficulty in activities of daily living (ADL). The DAD is administered through an interview with the caregiver. A total score is obtained by adding the rating for each question and converting this to a total score out of 100 (%). Higher scores represent less disability in ADL while lower scores indicate more dysfunction. A positive change score indicates an improvement from baseline.|Baseline and Week 24|Intent-to-treat population. Only patients with a valid baseline and post-baseline score were included.||units on a scale||Standard Deviation|Mean
735062|NCT00423085|Primary|Overall Clinical Rating of Change From Baseline to Week 24 Measured by the Clinician's Interview-Based Impression of Change Plus - Japan (CIBIC Plus-J)|"The overall clinical rating of change from baseline to week 24 measured by the 7-point CIBIC plus-J scale. The Clinician's Interview-Based Impression of Change plus Caregiver Input consists of 3 subscales: Disability Assessment of Dementia Scale, Behavioral Pathology in Alzheimer's Disease Rating Scale and Mental Function Impairment Scale, as well as the Clinician's Global Impression of Change (CGIC). Participants are scored according to the following:
Markedly improved
Moderately improved
Minimally improved
Unchanged
Minimally worse
Moderately worse
Markedly worse"|Baseline and Week 24|Intent-to-treat population utilizing LOCF.||Participants|||Number
735063|NCT00423085|Primary|Change From Baseline in the Alzheimer's Disease Assessment Scale - Japan Cognitive Subscale (ADAS-J Cog)|The Alzheimer's Disease Assessment Scale - Japan cognitive subscale (ADAS-J cog) was used to measure change in cognitive function. The ADAS-J cog score ranges from 0-70, with higher total scores indicating more impairment. A negative change score indicates improvement from baseline.|Baseline and Week 24|The Intent-to-treat population: This population includes all randomized patients who received at least one dose of study drug and had at least a baseline and any post-baseline assessment on treatment (i.e. not more than 2 days after the last known date of study drug) for one of the primary efficacy variables. LOCF was utilized.||units on a scale||Standard Deviation|Mean
735064|NCT00423098|Secondary|Change From Baseline in Overall Disease Activity With British Isles Lupus Assessment Group (BILAG)|BILAG (British Isles Lupus Assessment Group) index divides lupus activity into 8 organs/systems and was based on the principle of the physician's intention to treat, assessing activity in the previous one month. Each organ or system was given a score of A to E, where A = disease that is sufficiently active to require disease modifying treatment; a B = problems requiring symptomatic treatment; C = stable mild disease; D = previously affected but currently inactive system; and E = the system or organ has never been involved. [A=9, B=3, C=1, D/E=0 the score range for each patient will be 0-72].|From Baseline to week 4, week 12 and week 24|Intent-to-treat (ITT) populationincluded all randomized patients who received at least one dose of study drug. Only patients with assessments at both baseline and post-baseline visits are summarized.||Units on a scale||Standard Deviation|Mean
735065|NCT00423098|Secondary|Change From Baseline in Overall Disease Activity With Systematic Lupus Erythematosus Disease Activity Index (SLEDAI)|SLEDAI stands for Systemic Lupus Erythematosus Disease Activity Index and was a well established global score index based on assessment of 24 items measuring a disease activity in the 10-day period prior to the assessment. SLEDAI item weights range from 1 for fever to 8 for seizures. A maximum theoretical score is 105. Total score range from 1 to 105. A flare has been defined as a SLEDAI score increase of 3 or more to a level of 8 or higher. During flares SLEDAI scores of 25 to 30 are common.|From Baseline to week 4, week 12 and week 24|Intent-to-treat (ITT) population included all randomized patients who received at least one dose of study drug. Only patients with assessments at both baseline and post-baseline visits are summarized.||Units on a scale||Standard Deviation|Mean
735066|NCT00423098|Secondary|Number of Patients With Treatment Failure|Treatment failure was defined as no therapeutic response (without complete or partial remission) or premature discontinuation during the first 24 weeks from study medication or the study for any reason except complete or partial remission.|12 Weeks and 24 Weeks|Safety Population: All patients who received at least one dose of study drug and had at least one post-baseline safety assessment.||participants|||Number
735067|NCT00423098|Secondary|Number of Patients With Adverse Events and Infections|Safety assessments included collecting all adverse events (AEs), serious adverse events (SAEs), with their severity and relationship to study drug. According to FDA 21CFR 314.80, a serious adverse event (SAE) is described as any adverse event that leads to death, is life threatening ( NIH criteria Grade 4), causes or prolongs hospitalization, results in a congenital anomaly, or any other important medical event not described above.|24 weeks|Safety population: All patients who received at least one dose of study drug and had at least one post-baseline safety assessment.||participants|||Number
735068|NCT00423098|Secondary|Duration of Exposure to Study Medication|The duration of exposure was calculated as the date of the last Mycophenolate sodium dose minus the date of the last Mycophenolate sodium dose +1.|24 weeks|Safety population: All patients who received at least one dose of study drug and had at least one post-baseline safety assessment.||days||Standard Deviation|Mean
735115|NCT00423332|Primary|Percentage Change From Baseline in Tumour Size at 12 Weeks|Sum of longest diameters of the target lesions, based on Response Evaluation Criteria in Solid Tumours (RECIST) criteria ((Week 12 - baseline)/baseline)*100|Baseline to Week 12|For patients to be included in the analysis they had to have been evaluable for RECIST with week 12 or progression tumour size data||Percentage change from baseline||Standard Deviation|Mean
735069|NCT00423098|Secondary|Number of Patients With Moderate to Severe Flares|A moderate to severe flare was defined as the occurrence of increased lupus activity after partial or complete remission, based on the presence of 1 BILAG A score or >=3 BILAG B scores. British Isles Lupus Assessment Group (BILAG) index divides lupus activity in 8 organs/systems which are each given a score of A to E. A=disease sufficiently active to need disease modifying treatment; B=problems requiring symptomatic treatment; C=mild stable disease; D=previously affected but currently inactive system; E=the system or organ has never been involved. BILAG score: A=9, B=3, C=1, D/E=0; range(0-72)|12 and 24 weeks|Intention to treat (ITT) population: All randomized patients who received at least one dose of study drug.||participants|||Number
735070|NCT00423098|Secondary|Cumulative Dose of Prednisone Equivalent Corticosteroids (CS)|Corticosteroid use was measured as cumulative dose until 12 and 24 weeks of treatment as well as daily doses at baseline, 12 and 24 weeks.|12 Weeks and 24 Weeks|Intention to treat (ITT) population: All randomized patients who received at least one dose of study drug.||mg/kg||Standard Deviation|Mean
735071|NCT00423098|Secondary|Number of Patients With Partial Remission|Partial remission was defined as urine protein/creatinine ratio reduced by at least 50% from baseline and stable serum creatinine within 10% of baseline value) or improved.|Baseline to 12 and 24 weeks|Intention to treat (ITT) population: All randomized patients who received at least one dose of study drug.||Participants|||Number
735072|NCT00423098|Secondary|Number of Patients With Complete Remission|Complete remission was defined as urine protein/urine creatinine ratio < 0.5 gram urine protein per gram urine creatinine, urine sediment normalized (no cellular casts, < 5 red cells per high power field), and serum creatinine within 10% of normal value.|12 Weeks|Intention to treat (ITT) population: All randomized patients who received at least one dose of study drug.||participants|||Number
735073|NCT00423098|Primary|Number of Patients With Complete Remission|Complete remission was defined as urine protein/urine creatinine ratio < 0.5 gram urine protein per gram urine creatinine, urine sediment normalized (no cellular casts, < 5 red cells per high power field), and serum creatinine within 10% of normal range according to local lab.|24 Weeks|Intention to treat (ITT) population: All randomized patients who received at least one dose of study drug.||Participants|||Number
735074|NCT00423150|Primary|Tumor Responses (Complete and Partial Response)|"Tumor response rate was based on Response Evaluation Criteria in Solid Tumors (RECIST).
Complete Response (CR): Disappearance of all target lesions.
Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD."|From start of treatment until participant's disease progression, intolerable toxicity or death, which ever comes first|"Population for the primary outcome measure is all evaluable participants per protocol definition (82 participants).
Complete response is defined as disappearance of all target lesions.
Partial response is defined as at least 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD."||Participants|||Number
735075|NCT00423176|Primary|Change From Baseline to Endpoint in Percent of Opacification of the Maxillary Sinus That Had the Maximum Opacification Score at Baseline|A coronal computerized tomography was obtained to visulaize all nasal sinuses and the ostiomeatal complex. Opacification was measured as a percentage of the area of the sinus that was occupied by either fluid or mucosal thickening. The change in percentage of opacification of one maxillary sinus (the one with the highest percentage of opacification) as compared to antibiotic treatment alone. The percentage of opacification was measured and the change from baseline for that percentage was reported.|29-day Treatment Period and 2-week no-treatment Follow-up Period.|Not every randomized subject had complete data therefore the number of participants analyzed and the number of participants in the participant flow do not match.||Percentage of opacification||Standard Deviation|Mean
735076|NCT00423176|Primary|Baseline Change in AM/PM PRIOR Major Symptoms Score (Mss) Minus Sinus Headache Averaged Over Days 1 to 29.|The least squares mean decrease from Baseline in AM/PM PRIOR MSS, excluding sinus headache, averaged over Days 1 to 29. PRIOR is the subject's status over the previous 12 hours (reflective). The MSS was defined as the sum of the following subject-evaluated symptoms: facial pain/pressure/tenderness, sinus headache, purulent rhinorrhea, post-nasal drip, and nasal stuffiness/congestion.MSS scores are as follows: 0=none, 1=mild, 2=moderate, 3=severe for each individual symptom.|29-day Treatment Period and 2-week no-treatment Follow-up Period.|Not every randomized subject had complete data therefore the number of participants analyzed and the number of participants in the participant flow do not match.||Units on a scale||Standard Deviation|Mean
735077|NCT00423189|Secondary|Safety of Combination Therapy With Verteporfin PDT and ITV Ranibizumab|Safety of combination therapy with verteporfin PDT and ITV ranibizumab was not determined due to lack of efficacy.|1 Year||||||
735078|NCT00423189|Secondary|Choroidal Perfusion as Assessed by ICG Angiography at 1, 2, 3, 6, and 12 Months|Choroidal perfusion as assessed by ICG angiography at 1, 2, 3, 6, and 12 months was not determined due to lack of efficacy|1 Year||||||
735079|NCT00423189|Secondary|OCT 3 Macular Thickness Improvement (Baseline-1month, 2months, 3months, 6months &12 Months)|OCT 3 macular thickness improvement at Baseline-1month, 2months, 3months, 6months &12 months was not determined due to lack of efficacy.|1 Year||||||
735080|NCT00423189|Secondary|Number of Intravitreal Injections With Ranibizumab Needed by Patients at 12 Months|Number of intravitreal injections with ranibizumab needed by patients at 12 months was not determined due to lack of efficacy.|1 Year|not determined due to lack of efficacy|||||
735081|NCT00423189|Primary|Best-corrected ETDRS Visual Acuity at 6 Months and 12 Months Only Time Points (Gain or Loss of >15 Letters at 12 Months)|Visual Acuity was measured by ETDRS by certified refractionists in certified lanes at 12 months. Visual Acuity was not measured by ETDRS at 6 months.|1 Year|As per subjects participated||participants|||Number
735082|NCT00423267|Secondary|Number of Participant Discontinuations Due to Adverse Events and/or Laboratory Evaluations of Safety in Period B||12 months|||Participants|||Number
735083|NCT00423267|Secondary|Number of Participant Discontinuations Due to Adverse Events and/or Laboratory Evaluations of Safety in Period A||12 months|||Participants|||Number
735116|NCT00423358|Secondary|Short Form 36 Survey|12 month score for physical function domain of SF36 survey; scale 0 to 100 with 0 indicating worst disability and 100 indicating best physical function|1 Year|Intent to treat analysis||units from 0 (worst) to 100 (best)||95% Confidence Interval|Mean
735117|NCT00423358|Secondary|Bone Mineral Density|one year change in mean total hip BMD|1 Year|Intent to treat analysis||g/cm2||Standard Deviation|Mean
735084|NCT00423267|Secondary|Number of Participants With Laboratory Abnormalities (at Least a 1 Grade Shift From Baseline) That Occurred With POS in Period B|Severity grading was based on Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. This is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE; Grade 2 Moderate AE; Grade 3 Severe AE; Grade 4 Life-threatening or disabling AE; Grade 5 Death related to AE.|12 months|||Participants|||Number
735085|NCT00423267|Primary|Number of Participants With Treatment-related Treatment-emergent Adverse Events (TRAEs) That Occurred With Posaconazole (POS) in Period B|"Treatment-emergent adverse events are defined as new events that occur following subject entry into the study or events that worsen following study entry state.
Treatment-related adverse events are defined as new events that occur following subject entry into the study or events that worsen following study entry state and are judged by the investigator to be possibly, probably or definitely related to study medication."|12 months|||Participants|||Number
735086|NCT00423267|Secondary|Number of Participants With Laboratory Test Abnormalities (at Least a 1 Grade Shift From Baseline) That Occurred With POS or FLU in Period A|Severity grading was based on Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. This is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE; Grade 2 Moderate AE; Grade 3 Severe AE; Grade 4 Life-threatening or disabling AE; Grade 5 Death related to AE.|12 months|||Participants|||Number
735087|NCT00423267|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) That Occurred With POS in Period B|Treatment-emergent adverse events are defined as new events that occur following subject entry into the study or events that worsen following study entry state.|12 months|||Participants|||Number
735088|NCT00423267|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs)That Occurred With POS or FLU in Period A|Treatment-emergent adverse events are defined as new events that occur following subject entry into the study or events that worsen following study entry state.|12 months|||Participants|||Number
735089|NCT00423267|Primary|Number of Participants With Treatment-related Treatment-emergent Adverse Events (TRAEs) That Occurred With Posaconazole (POS) or Fluconazole (FLU) in Period A|"Treatment-emergent adverse events are defined as new events that occur following subject entry into the study or events that worsen following study entry state.
Treatment-related adverse events are defined as new events that occur following subject entry into the study or events that worsen following study entry state and are judged by the investigator to be possibly, probably or definitely related to study medication."|12 months|||Participants|||Number
735090|NCT00423293|Secondary|Efficacy of Treatment, in Terms of Locoregional Failure, Disease-free Survival, Time to Colostomy, Colostomy-free Survival, and Overall Survival||From registration to date of failure, death or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years.||||||
735091|NCT00423293|Secondary|Radiotherapy Treatment Time||From start to end of radiation therapy||||||
735092|NCT00423293|Secondary|Clinical Complete Response Rate||From registration to 8 and 12 weeks after treatment completion||||||
735093|NCT00423293|Secondary|Adverse Event Rates as Defined by CTCAE v 3.0 Within 90 Days From the Start of Study Treatment||From the start of treatment to 90 days||||||
735094|NCT00423293|Secondary|Reproducibility of the Intensity-modulated Radiation Therapy Technique||IMRT planning and dosing data is centrally reviewed for quality assurance||||||
735095|NCT00423293|Primary|Gastrointestinal (GI) and Genitourinary (GU) Adverse Events (AE) ≥ Grade 2 as Defined by CTCAE v3.0 (Common Terminology Criteria for Adverse Events)||From the start of treatment to 90 days|Eligible patients with adverse event information.||percentage of participants||95% Confidence Interval|Number
735096|NCT00423319|Secondary|Rates of Adjudicated Myocardial Infarction (MI)/Stroke, MI, Stroke, and Thrombocytopenia During the Intended Treatment Period|Event rate=Number of events divided by the number of patients evaluated. All suspected events were reported by investigator. Acute MI=the presence of a clinical situation (eg, abnormal history, physical examination, new electrocardiogram changes) suggestive of an MI and at least 1 of the following: elevated creatine kinase (CK)-MB or troponin T or troponin I ≥2*upper limit of normal (ULN); if CK-MB or troponin values not available, total CK ≥2*ULN; or new significant (≥0.04 sec) Q waves in ≥2 contiguous leads. Stroke=a new focal neurologic deficit of sudden onset lasting at least 24 hours that was not due to a readily identifiable nonvascular cause. Adjudication classified each reported stroke as primary hemorrhagic, nonhemorrhagic, infarction with hemorrhagic conversion, or unknown type. Thrombocytopenia=after 3 days as drop in platelet count to <100,000/mm^3 for patients with a baseline value >150,000/mm^3 or a >50% decline, if the baseline value was ≤150,000/mm^3.|Day 1 (first dose of study drug) to later of 2 days after last dose or 38 days after first dose|All participants who received at least 1 dose of study drug||Percent of events/patients evaluated||95% Confidence Interval|Number
735097|NCT00423319|Secondary|Number of Participants With Adverse Events Related to Elevations in Liver Function Test Results With Onset During the Treatment Period|Treatment guidelines were provided for jaundice and elevated results of liver function tests.|First dose of study drug (presurgery) through 30 days after the last dose of study drug|All participants who received at least 1 dose of study drug||Participants|||Number
735105|NCT00423319|Secondary|Number of Participants With Serious Adverse Events (SAEs), Bleeding Adverse Events (AEs), and Death as Outcome|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. All suspected bleeding events were to be reported by the investigator as either an AE or SAE and adjudicated by the Independent Central Adjudication Committee (ICAC). Definitions of bleeding outcomes: Acute clinically overt bleeding =new onset, visible bleeding, or signs or symptoms suggestive of bleeding with confirmatory imaging techniques that could detect the presence of blood.|First dose of study drug (presurgery) through 30 days after the last dose of study drug|All participants who received at least 1 dose of study medication||Participants|||Number
735098|NCT00423319|Secondary|Number of Participants With Marked Abnormalities (MA) in Clinical Laboratory Test Results During the Treatment Period (Continued)|preRx=predose; LLN=lower limit of normal; ULN=upper limit of normal. Glucose, fasting (mg/dL): <.8*LLN or >1.5*ULN, or if preRx <LLN use <.8*preRx or >ULN if preRx >ULN use >2*preRx or <LLN; protein, total (g/L): If missing preRx use ≥2, or if value ≥4 or preRx =0 or .5 use ≥2, or if preRx=1 use ≥3, or if preRx =2 or 3 use ≥4; creatine kinase (U/L): >5*ULN; uric acid (mg/dL): >.5* ULN, or if preRx >ULN use >2*preRx; blood, urine: If missing preRx use ≥2, or if value ≥4, or if preRx=0 or 0.5 use ≥2, or if preRx=1 use ≥3, or if preRx =2 or 3 use ≥4; glucose, urine : If missing preRx use ≥2, or if value ≥4, or if preRx=0 or .5 use ≥2, or if preRx=1 use ≥3, or if preRx=2 or 3 use ≥4; RBC, urine (hpf): If missing preRx use ≥2, or if value ≥4, or if preRx=0 or 0.5 use ≥2, or if preRx dose= 1 use ≥3, or if preRx=2 or 3 use ≥4; WBC, urine (h): If missing preRx use ≥2, or if value ≥4, or if preRx =0 or .5 use ≥2, or if preRx =1 use ≥3, or if preRx=2 or 3 use ≥4.|First dose of study drug (presurgery) through 2 days after the last dose of study drug|All participants who received at least 1 dose of study drug||Participants|||Number
735099|NCT00423319|Secondary|Number of Participants With Marked Abnormalities (MA) in Clinical Laboratory Test Results During the Treatment Period (Continued)|preRx=predose; LLN=lower limit of normal; ULN=upper limit of normal. Alanine aminotransferase (ALT) (U/L): >3 *ULN: alkaline phosphatase (ALP) (U/L): >2* ULN; aspartate aminotransferase (ASP) (U/L): >3 *ULN; bilirubin, direct (mg/dL): >2*ULN; bilirubin, total (mg/dL): >2*ULN; BUN (mg/dL): >2*ULN; creatinine (mg/dL): >1.5*ULN; calcium (mg/dL): < 0.8*LLN or >1.2 *ULN, or if preRx <LLN use <0.75* preRx or >ULN if preRx >ULN use > 1.25*preRx or <LLN; chloride (mEq/L): <0.9*LLN or >1.1*ULN, or if preRx <LLN use <0.9*preRx or >ULN if preRx >ULN use >1.1* preRx or <LLN; bicarbonate (mEq/L): < 0.75* LLN or >1.25*ULN, or if preRx <LLN use <0.75*preRx or >ULN if preRx >ULN use >1.25*preRx or <LLN; potassium (mEq/L): < 0.9*LLN or >1.1*ULN, or if preRx <LLN use <0.9*preRx or >ULN if preRx >ULN use >1.1* preRx or < LLN; sodium (mEq/L): <0.95* LLN or >1.05×ULN, or if preRx <LLN use <0.95* predose or >ULN if preRx >ULN use >1.05 *preRx or < LLN.|First dose of study drug (presurgery) through 2 days after the last dose of study drug|All participants who received at least 1 dose of study drug||Participants|||Number
735100|NCT00423319|Secondary|Number of Participants With Marked Abnormalities (MA) in Clinical Laboratory Test Results During the Treatment Period|preRx=predose; LLN=lower limit of normal; ULN=upper limit of normal. MA criteria: Hemoglobin: >2 g/dL decrease from preRx or value ≤ 8 g/dL; hematocrit (%): <0.75*preRx; platelet count (*10^9 cells/L): <100,000/mm^3; erythrocytes (*10^6 cells/μL): <0.75*preRx level; leukocytes (*10^3 cells/μL): < 0.75*LLN or >1.25*ULN, or if preRx LLN use < 0.8*preRx or >ULN if preRx >ULN use >1.2*preRx or <LLN; basophils (*10^3 cells/μL): >400/mm^3; eosinophils (*10^3 cells/μL): > 0.75*10^3 cells/μL; lymphocytes (*10^3 cells/μL): >0.75*10^3 cells/μL; monocytes (*10^3 cells/μL): >2000/mm^3; neutrophils (*10^3 cells/μL): <1.0;|First dose of study drug (presurgery) through 2 days after the last dose of study drug|All participants who received at least 1 dose of study drug||Participants|||Number
735101|NCT00423319|Secondary|Number of Participants With Neurologic Adverse Events With Onset During the Treatment Period|Neurologic events were based on Medical Dictionary for Regulatory Activities search categories.For new or worsening events that were not related to the site of surgery, additional information was collected on a specific form. In addition, neurology consultation was to be obtained for these patients.|First dose of study drug (presurgery) through 2 days after the last dose of study drug|All participants who received at least 1 dose of study drug||Participants|||Number
735102|NCT00423319|Secondary|Number of Participants With a Bleeding-related Adverse Event During the Treatment Period (Continued)|All suspected bleeding events were to be reported by the investigator as either an adverse event or serious adverse event or and adjudicated by the Independent Central Adjudication Committee (ICAC). Definitions of bleeding outcomes: Acute clinically overt bleeding =new onset, visible bleeding, or signs or symptoms suggestive of bleeding with confirmatory imaging techniques that could detect the presence of blood. All acute clinically overt bleeding events were adjudicated by the ICAC as a major bleeding event or a clinically relevant nonmajor bleeding event; suspected minor bleeding events were not sent for adjudication.|First dose of study drug (presurgery) through 2 days after the last dose of study drug|All participants who received at least 1 dose of study drug||Participants|||Number
735103|NCT00423319|Secondary|Number of Participants With a Bleeding-related Adverse Events During the Treatment Period (Continued)|All suspected bleeding events were to be reported by the investigator as either an adverse event or serious adverse event or and adjudicated by the Independent Central Adjudication Committee (ICAC). Definitions of bleeding outcomes: Acute clinically overt bleeding =new onset, visible bleeding, or signs or symptoms suggestive of bleeding with confirmatory imaging techniques that could detect the presence of blood. All acute clinically overt bleeding events were adjudicated by the ICAC as a major bleeding event or a clinically relevant nonmajor bleeding event; suspected minor bleeding events were not sent for adjudication.|First dose of study drug (presurgery) through 2 days after the last dose of study drug|All participants who received at least 1 dose of study drug||Participants|||Number
735104|NCT00423319|Secondary|Number of Participants With a Bleeding-related Adverse Event During the Treatment Period|All suspected bleeding events were to be reported by the investigator as either an adverse event or serious adverse event or and adjudicated by the Independent Central Adjudication Committee (ICAC). Definitions of bleeding outcomes: Acute clinically overt bleeding =new onset, visible bleeding, or signs or symptoms suggestive of bleeding with confirmatory imaging techniques that could detect the presence of blood. All acute clinically overt bleeding events were adjudicated by the ICAC as a major bleeding event or a clinically relevant nonmajor bleeding event; suspected minor bleeding events were not sent for adjudication.|First dose of study drug (presurgery) through 2 days after the last dose of study drug|All participants who received at least 1 dose of study drug||Participants|||Number
735113|NCT00423332|Secondary|Duration of Response|Based on RECIST measurements taken throughout the study and best objective tumour response at the defined analysis cut-off point. Measured from the time the criteria for complete response (CR)/partial response (PR) are first met (whichever is recorded first) until the patient progresses or dies.|Treatment period up to 2nd data cut-off of 8th March 2009|"For patients to be included in the analysis they had to have been evaluable for RECIST and have been a responder (Complete response (CR) or Partial Response (PR)).
13 of the 19 responders had not progressed by the data cut off so their responses are ongoing and are censored at the date of the last evaluable visit before the data cut-off."||Months||Inter-Quartile Range|Median
735106|NCT00423319|Secondary|Rate of Major Bleeding, Clinically Relevant Nonmajor Bleeding (CRNM), Major or CRNM, and Any Bleeding During the Treatment Period|Event rate=Number of events divided by the number of patients evaluated. Major bleeding event defined as a bleeding event that was 1) Acute clinically overt bleeding accompanied by at least 1 of the following: decrease in hemoglobin of ≥ 2 g/dL over a 24-hour period, transfusion of ≥2 units of packed red blood cells; bleeding that occurred in at least 1 of the following sites: intracranial, intra-spinal, intraocular, pericardial, an operated joint and requires reoperation or intervention, intramuscular with compartment syndrome, or retroperitoneal; 2) Fatal. CRNM was defined as acute clinically overt bleeding that did not satisfy the criteria for a major bleeding event and met at least 1 of the following: epistaxis, gastrointestinal bleed, hematuria, bruising/ecchymosis, or hemoptysis. Minor bleeding was defined as an acute clinically overt bleeding event that did not meet the criteria for major bleeding or a CRNM. Fatal bleeding event was defined as bleeding that was the primary|First dose of study drug (presurgery) through 2 days after the last dose of study drug|All participants who received at least 1 dose of study drug||Percentage of events/patients evaluted||95% Confidence Interval|Number
735107|NCT00423319|Secondary|Rates of Adjudicated All-cause Death, VTE-related Death, Pulmonary Embolism (PE), Nonfatal PE, Deep Vein Thrombosis (DVT) (Symptomatic and Asymptomatic), Symptomatic and Asymptomatic Proximal and Distal DVT During the Intended Treatment Period|VTE=venous thromboembolic event; VTE-related death=combination of fatal or nonfatal PE and symptomatic or asymptomatic DVT. Event rate=Number of events divided by the number of patients evaluated.|Day 1 (first dose of study drug) to later of 2 days after last dose or 38 days after first dose|All participants randomized to treatment||Percentage of events/patients evaluated|||Number
735108|NCT00423319|Secondary|Rate of Composite of Adjudicated Proximal Deep Vein Thrombosis (DVT), Nonfatal Pulmonary Embolism, and Venous Thromboembolic Event-related Death With Onset During Intended Treatment Period|Event rate=Number of events divided by the number of patients evaluated. Each patient was categorized as having no proximal DVT, having proximal DVT, being nonevaluable for proximal DVT, having no distal DVT, having distal DVT, or being nonevaluable for distal DVT. Adjudication criteria were: Normal=All deep veins were visualized, and there was no intraluminal filling defect (ILFD). ILFD=An area of reduced, or absent filling, at least partially surrounded with contrast medium in ≥ 2 projections or a lack of filling in a vessel in which there was a cut-off that had the configuration of a thrombus. Indeterminate=A lack of filling of a region of the deep vein system, proximal or distal, without the presence of an ILFD elsewhere in the same region. Not Done=A venography was not performed. Proximal DVT was found if any of the proximal veins had an ILFD. Pulmonary embolism was radiographically (angiography, V/Q scan, computed tomography) determined.|Day 1 (first dose of study drug) to later of 2 days after last dose or 38 days after first dose|Randomized participants with either an adjudicated event or an adjudicated evaluable bilateral venogram||Percentage of events/patients evaluated||95% Confidence Interval|Number
735109|NCT00423319|Primary|Rate of Composite of Adjudicated Venous Thromboembolic Event (VTE)-Related (Pulmonary Embolism and Symptomatic and Asymptomatic Deep Vein Thrombosis[DVT]) and All-cause Death During the Intended Treatment Period|Event rate=Number of events divided by the number of patients evaluated. A mandatory bilateral ascending contrast venogram was to be obtained on Day 35 (± 3). Patients with confirmed symptomatic DVT at any time, or asymptomatic DVT upon venography, were to receive treatment for DVT according to the investigator’s standard of care. Signs and symptoms suggestive of VTE included, but were not limited to: 1) lower extremity DVT: erythema, warmth, pain, swelling, tenderness; and 2) PE: pleuritic chest pain, dyspnea, cough, hemoptysis, syncope, light-headedness/dizziness, tachypnea, and tachycardia. Intended Treatment Period started on day of randomization and, for patients who received treatment, ended at the later of 2 days after last dose of study drug or 38 days after the first dose (presurgery) of study drug. For randomized patients who did not receive study drug, the period ended 38 days after randomization.|Day 1 (first dose of study drug) to later of 2 days after last dose or 38 days after first dose|All randomized participants who, during the Intended Treatment Period, had an adjudicated and evaluable bilateral venogram, had an adjudicated venous thromboembolic event, or died of any cause.||Percentage of events/patients evaluated||95% Confidence Interval|Number
735110|NCT00423332|Secondary|Best Objective Tumour Response|Best Objective Tumour response as defined by RECIST. Patients were assigned to 1 of the following best objective tumour response categories: complete response (CR) defined as a Disappearance of all target lesions, partial response (PR), defined as At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD, stable disease (SD) defined as Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD since the treatment started, or progressive disease (PD) defined as At least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded (either at baseline or at previous assessment since treatment began). Patients who were evaluable for RECIST assessments, but who did not meet the criteria for CR, PR, SD, or PD, were assigned to the response category of not evaluable (NE).|Baseline, Week 12 and every 8 weeks thereafter or until progression.|For the patients who switched from placebo to cediranib after unblinding, the baseline RECIST assessment was not reset to their last scan placebo, owing to the methods of data collection; therefore, it was not possible to determine their subsequent response to cediranib treatment using a ‘best response’ summary.||Participants|||Number
735111|NCT00423332|Secondary|Objective Tumour Response at 12 Weeks|Number of patients with complete (CR) /partial response (PR) (based on RECIST). CR is defined as Disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of Longest Diameter (LD) of target lesions taking as reference the baseline sum LD. At 12 weeks, tumour responses would be unconfirmed, as this was the first post-baseline RECIST assessment, unless a patient had a RECIST assessment before Week 12 to confirm a suspected progression.|Response rate at 12 weeks was based on RECIST measurements taken at baseline and at Week 12, or upon progression if this was before Week 12.|||Participants|||Number
735112|NCT00423332|Secondary|Progression Free Survival|Number of months from randomisation until progressive disease based on RECIST (progression of target lesions, clear progression of existing non-target lesions or the appearance of one or more new lesions) or death in the absence of progression.|Treatment period up to 2nd data cut-off of 8th March 2009.|Comparison of PFS between patients randomised to cediranib 45 mg versus those randomised to placebo. All patients irrespective of whether they had a 12 week scan are included in this analysis. At week 12 placebo patients were able to switch to cediranib.||Months||Full Range|Median
735119|NCT00423436|Primary|Ratio of Number of Alerts Generated by Symptom Distress Over the Number of Available Assessments|Total number of alerts generated by symptom exceeding prespecified threshold for 7 symptoms - pain, fatigue, nausea, cough, constipation, vomiting and shortness of breath (Ratio alerts/number of assessments using IVR telephone triage/feedback versus IVR only). Reporting 0-10 severity scale of MD Anderson Symptom Inventory from 0 (symptom not present) to 10 (symptom bad as imagine it could be). Thresholds set at 4 on scale for all symptoms except shortness of breath and constipation where threshold set at 2. More than one symptom alert may appear per assessment causing ratio values to exceed 1.|Baseline to end of first chemotherapy cycle (generally chemotherapy and 1 assessment of response within 6-8 weeks)|Analysis was per protocol. Due to attrition, data from 61 participants were analyzed at end of first chemotherapy cycle and from 27 participants at the end of the study.||Ratio of alerts/number of assessments|Participants||Number
735120|NCT00423449|Primary|Maximum Tolerated Dose of Vorinostat Administered in Combination With Standard Doses of Gemcitabine Plus Either Cisplatin or Carboplatin in Patients With Advanced Stage Non-Small Cell Lung Cancer Who Have Not Received Chemotherapy for Advanced Disease|"Maximum tolerated dose (MTD) was defined as the highest dose level in which fewer than 2 patients among the first 6 enrolled experience a DLT (as defined in Outcome Measure 1) during the first cycle of treatment.
The MTD was 400 mg for up to 10 days in 21-day cycles."|every 21 days (every cycle), up to 126 days (6 cycles)|||mg|||Number
735121|NCT00423449|Secondary|Number of Participants With Laboratory Adverse Experiences (Safety and Tolerability)|"An adverse experience was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening (any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the sponsor's product, was also an adverse experience.
The AEs could have been any grade from 1 to 5 in severity (mild, moderate, severe, life-threatening, death, respectively)."|every 21 days (every cycle), up to 126 days (6 cycles)|||Participants|||Number
735122|NCT00423449|Secondary|Number of Participants With Clinical Adverse Experiences (Safety and Tolerability)|"An adverse experience (AE) was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening (any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the sponsor's product, was also an adverse experience.
The AEs could have been any grade from 1 to 5 in severity (mild, moderate, severe, life-threatening, death, respectively)."|every 21 days (every cycle), up to 126 days (6 cycles)|||Participants|||Number
735123|NCT00423449|Primary|Number of Participants With Dose-limiting Toxicities (DLT) Due to Vorinostat Administered in Combination With Standard Dose of Gemcitabine Plus Either Cisplatin or Carboplatin|DLT = any Common Terminology Criteria for Adverse Events Grade 3/4 drug related non-hematologic toxicity EXCEPT Grade 3 nausea/vomiting responsive to therapy, Grade 3 Fatigue responsive to management, transient electrolyte disorders that were corrected, any Grade 4 drug related hematologic toxicity EXCEPT lymphopenia/neutropenia, unless the neutropenia was febrile and/or was an infection requiring treatment, OR Any Grade 4 neutropenia lasting >=7 days, failure of absolute neutrophil count or platelets to recover, or any drug-related AE that led to a dose reduction of >=1 study drugs.|every 21 days (every cycle), up to 126 days (6 cycles)|||Participants|||Number
735124|NCT00423488|Primary|Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Endpoint, After 6 Weeks of Treatment||6 weeks of treatment (from Baseline to Endpoint)|Intent-to-treat population only.||percentage change||Standard Deviation|Mean
735125|NCT00423579|Primary|Change in Low-density-lipoprotein Cholesterol (LDL-C) at 6 Weeks|Percentage change in LDL C from baseline to endpoint after 6 weeks of treatment.|Baseline and 6 weeks|Intent-to-treat population only.||percentage change||Standard Deviation|Mean
735126|NCT00423592|Secondary|Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - Mental Health|The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). Each item is scored from 0 to 100 (least healthy to most healthy).|Baseline to Week 12|The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value.||Units on a scale||Standard Deviation|Mean
735127|NCT00423592|Secondary|Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - Role Emotional|The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). Each item is scored from 0 to 100 (least healthy to most healthy).|Baseline to Week 12|The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value.||Units on a scale||Standard Deviation|Mean
735128|NCT00423592|Secondary|Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - Social Functioning|The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). Each item is scored from 0 to 100 (least healthy to most healthy).|Baseline to Week 12|The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value.||Units on a scale||Standard Deviation|Mean
735138|NCT00423592|Secondary|A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in the 6-Minute Walk Distance Test (6MWD)|The 6MWD test is a measure of exercise tolerance, and measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface.|Baseline to Week 12|The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value.||meters||Standard Deviation|Mean
735129|NCT00423592|Secondary|Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - Vitality|The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). Each item is scored from 0 to 100 (least healthy to most healthy).|Baseline to Week 12|The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value.||Units on a scale||Standard Deviation|Mean
735130|NCT00423592|Secondary|Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - General Health|The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). Each item is scored from 0 to 100 (least healthy to most healthy).|Baseline to Week 12|The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value.||Units on a scale||Standard Deviation|Mean
735131|NCT00423592|Secondary|Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - Bodily Pain|The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). Each item is scored from 0 to 100 (least healthy to most healthy).|Baseline to Week 12|The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value.||Units on a scale||Standard Deviation|Mean
735132|NCT00423592|Secondary|Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - Role Physical|The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). Each item is scored from 0 to 100 (least healthy to most healthy).|Baseline to Week 12|The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value.||Units on a scale||Standard Deviation|Mean
735133|NCT00423592|Secondary|Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - Physical Functioning|The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). Each item is scored from 0 to 100 (least healthy to most healthy).|Baseline to Week 12|The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value.||Units on a scale||Standard Deviation|Mean
735134|NCT00423592|Secondary|Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - Composite Mental Health|The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). The last 5 concepts constitute the mental component summary. Each item is scored from 0 to 100 (least healthy to most healthy).|Baseline to Week 12|The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value.||Units on a scale||Standard Deviation|Mean
735135|NCT00423592|Secondary|A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in Short Form 36 (SF-36) Health Survey Scale - Composite Physical Health|The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). The first 6 concepts constitute the physical component summary. Each item is scored from 0 to 100 (least healthy to most healthy).|Baseline to Week 12|The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value.||Units on a scale||Standard Deviation|Mean
735136|NCT00423592|Secondary|A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in WHO Functional Class|Classes: I) pulmonary hypertension (PH); ordinary physical activity not limited or causes undue dyspnea or fatigue, chest pain, or near syncope. II) PH; ordinary physical activity slightly limited and causes undue dyspnea or fatigue, chest pain, or near syncope; comfortable at rest. III) PH; physical activity markedly limited and less than ordinary physical activity causes undue dyspnea or fatigue, chest pain, or near syncope; comfortable at rest. IV) PH; physical activity causes symptoms and increased discomfort; signs of right heart failure; dyspnea/fatigue possibly at rest.|Baseline to Week 12|The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value.||Participants|||Number
735137|NCT00423592|Secondary|A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in Borg Dyspnea Index Immediately Following Exercise|Change from baseline evaluated after 12 weeks of ambrisentan therapy in Borg dyspnea index (measured as units on a scale) immediately following exercise. Borg Dyspnea Index, a measure of perceived shortness of breath: 0 units on a scale (none) to 10 units on a scale (maximum breathlessness).|Baseline to Week 12|The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value.||Units on a scale||Standard Deviation|Mean
735139|NCT00423592|Secondary|The Incidence of Confirmed Serum ALT or AST Concentrations > 3 x ULN That Were Related to Ambrisentan and Resulted in Dose Reduction|The number of participants in the safety analysis set with confirmed serum ALT or AST concentrations > 3 x ULN during 12 weeks of ambrisentan therapy that were related to ambrisentan and resulted in dose reduction. Safety analysis set included all participants who received at least 1 dose of study drug.|Week 12|The Safety analysis set was defined as all subjects who received at least 1 dose of study drug. All subjects who received at least 1 dose of ambrisentan were followed (to the extent possible) to the end of the study and included in the analyses of safety.||participants|||Number
735140|NCT00423592|Secondary|The Incidence of Confirmed Serum ALT or AST Concentrations > 5 x ULN That Were Related to Ambrisentan and Resulted in Discontinuation of Study Drug.|The number of participants in the safety analysis set with confirmed serum ALT or AST concentrations > 5 x ULN during 12 weeks of ambrisentan therapy that were related to ambrisentan and resulted in discontinuation of drug. Safety analysis set included all participants who received at least 1 dose of study drug.|Week 12|The Safety analysis set was defined as all subjects who received at least 1 dose of study drug. All subjects who received at least 1 dose of ambrisentan were followed (to the extent possible) to the end of the study and included in the analyses of safety.||participants|||Number
735141|NCT00423592|Primary|The Incidence of Confirmed Serum Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) Concentrations > 3 x the Upper Limit of Normal (ULN) Considered to be Related to Ambrisentan and Resulted in Discontinuation of Study Drug.|The number of participants in the safety analysis set with confirmed serum ALT or AST concentrations > 3 x ULN during 12 weeks of ambrisentan therapy that were related to ambrisentan and resulted in discontinuation of study drug. Safety analysis set included all participants who received at least 1 dose of study drug.|Week 12|The Safety analysis set was defined as all subjects who received at least 1 dose of study drug. All subjects who received at least 1 dose of ambrisentan were followed (to the extent possible) to the end of the study and included in the analyses of safety.||Participants|||Number
735142|NCT00423605|Primary|Number of Subjects Reporting Adverse Events|Number of subjects reporting adverse events.|Treatment Period (38 weeks)|||Participants|||Number
735143|NCT00423657|Secondary|To Evaluate Safety||first study drug dose through TOC||||||
735144|NCT00423657|Secondary|To Evaluate Microbiological Reinfection or Recurrence at the LFU Visit||21-35 days after last dose of study drug||||||
735145|NCT00423657|Secondary|To Evaluate Clinical Relapse at the Late Follow Up (LFU) Visit||21 to 35 days after the last dose of study drug||||||
735146|NCT00423657|Secondary|To Evaluate the Clinical and Microbiological Response by Pathogen at the TOC Visit||8-15 days after last dose of study drug||||||
735147|NCT00423657|Secondary|To Evaluate the Clinical Response at the End of Therapy (EOT) Visit||last day of study drug administration||||||
735148|NCT00423657|Secondary|To Evaluate the Microbiological Success Rate at the TOC Visit||8-15 days after the last dose of study drug||||||
735149|NCT00423657|Primary|The Primary Efficacy Outcome Measure Was the Per-subject Clinical Cure Rate at the TOC Visit in the Clinically Evaluable (CE) Populations.||8-15 days after last dose of study drug||||||
735150|NCT00423657|Primary|Clinical Cure Rate at Test of Cure (TOC) (MITT Population)|"Cure: Total resolution of all signs and symptoms of the baseline infection, or improvement of the infection such that no further antimicrobial therapy was necessary.
Failure: Requirement of alternative antimicrobial therapy for primary infection of complicated skin and skin structure infection (cSSSI) due to inadequate response, recurrence, new infection at the same site; treatment-limiting adverse event (AE); requirement for surgery due to failure of study drug; diagnosis of osteomyelitis after Study Day 8; or death caused by cSSSI.
Indeterminate: Inability to determine an outcome"|8-15 days after last dose of study drug administration|MITT (Modified Intent to Treat) - all subjects that received any amount of study drug||participants|||Number
735151|NCT00423670|Secondary|Number of Participants With a Virologic Response at 72 Weeks Post Randomization That Achieved SVR|"Participants with undetectable HCV-RNA at 72 weeks post randomization that achieved SVR (have undetectable HCV-RNA at FW 24 up to EOF) are reported.
Participants missing data at FW 24 were considered to achieve SVR if
he/she had undetectable HCV-RNA at FW 12 or later
if he/she returned later to the study center and had undetectable HCV-RNA.
HCV-RNA in plasma samples was detected an the RT-PCR assay. The lower limit of detection (LLD) was 29 IU/mL."|At FW 24 up to EOF and at 72 weeks post randomization|Participants who achieved SVR.||Participants|||Number
735152|NCT00423670|Secondary|Number of Participants With a Virologic Response at Follow-up Week 12 That Achieved SVR|"Treatment-naïve adults with CHC genotype 1 were assigned study medication. Participants with undetectable HCV-RNA at FW 12 that achieved SVR (have undetectable HCV-RNA at FW 24 (up to EOF) are reported.
Participants missing data at FW 24 were considered to achieve SVR if
he/she had undetectable HCV-RNA at FW 12 or later
if he/she returned later to the study center and had undetectable HCV-RNA.
HCV-RNA in plasma samples was detected with an RT-PCR assay. The LLD for the assay was 29 IU/mL."|At FW 12 and FW 24 up to EOF|Participants with undetectable HCV-RNA at FW 12.||Participants|||Number
735153|NCT00423670|Secondary|Number of Participants With an Early Virologic Response (EVR) That Achieved SVR|"Participants with undetectable HCV-RNA at TW 12 have EVR, and with undetectable HCV-RNA at FW 24 (up to EOF) achieved SVR.
Participants missing data at FW 24 were considered to achieve SVR if
he/she had undetectable HCV-RNA at FW 12 or later
if he/she returned later to the study center and had undetectable HCV-RNA.
HCV-RNA in plasma samples was detected with an RT-PCR assay. The LLD for the assay was 29 IU/mL."|At TW 12, and at FW 24 up to EOF|Participants with an early virologic response (EVR).||Participants|||Number
735154|NCT00423670|Secondary|Number of Participants Negative for HCV-RNA at 72 Weeks Post Randomization|"Participants who had undetectable HCV-RNA at 72 weeks post randomization are reported. Participants with missing HCV-RNA values at 72 weeks post randomization are also reported.
HCV-RNA in plasma samples was detected with an RT-PCR assay. The LLD for the assay was 29 IU/mL."|72 weeks post randomization|||Participants|||Number
735155|NCT00423670|Secondary|Number of Participants Negative for HCV-RNA at FW 12|"Participants who had undetectable plasma HCV-RNA at FW 12. Also reported are participants for whom the HCV-RNA values were missing. 36 participant who switched over to Arm 8 from Arm 1, are included in the missing values for Arm 1.
HCV-RNA in plasma samples was detected with an RT-PCR assay. The LLD for the assay was 29 IU/mL."|At FW 12|Intent-to-Treat (ITT) population: All randomized participants who received at least one dose of any study medication (PegIntron, ribavirin, or boceprevir).||Participants|||Number
735156|NCT00423670|Secondary|Number of Participants With SVR Based on Duration of Boceprevir Treatment|"Number of participants with SVR (undetectable plasma HCV-RNA at FW 24 up to EOF). Participants from treatment arms receiving boceprevir for 28-weeks (Arm 2 and Arm 3) were pooled, and those receiving boceprevir for 48-weeks (Arm 4 and Arm 5) were pooled for the analysis.
Participants missing data at FW 24 were considered to achieve SVR if
he/she had undetectable HCV-RNA at FW 12 or later
he/she returned later to the study center and had undetectable HCV-RNA.
HCV-RNA in plasma samples was detected with an RT-PCR assay. The LLD for the assay was 29 IU/mL."|From FW 24 up to EOF|Intent-to-Treat (ITT) population: All randomized participants who received at least one dose of any study medication (PegIntron, ribavirin, or boceprevir).||Participants|||Number
735157|NCT00423670|Secondary|Number of Participants With SVR Based on a 4-week lead-in Treatment With PegIntron and Ribavirin|"Number of participants with SVR (undetectable plasma HCV-RNA at FW 24 up to EOF). To assess the effect of lead-in treatment on SVR, participants with (Arm 3 and Arm 5) or without (Arm 2 and Arm 4) lead-in were pooled.
Participants missing data at FW 24 were considered to achieve SVR if
he/she had undetectable HCV-RNA at FW 12 or later
he/she returned later to the study center and had undetectable HCV-RNA.
HCV-RNA in plasma samples was detected with an RT-PCR assay. The LLD for the assay was 29 IU/mL."|From FW 24 up to EOF|Intent-to-Treat (ITT) population: All randomized participants who received at least one dose of any study medication (PegIntron, ribavirin, or boceprevir).||Participants|||Number
735158|NCT00423670|Primary|Number of Participants With Sustained Virologic Response (SVR)|"Participants with undetectable HCV-RNA at FW 24 up to EOF had achieved SVR.
Participants missing data at FW 24 were considered to achieve SVR if
he/she had undetectable HCV-RNA at FW 12 or later
he/she returned later to the study center and had undetectable HCV-RNA.
HCV-RNA in plasma samples was detected with reverse-transcriptase-polymerase chain reaction (RT-PCR) assay, with a lower limit of detection (LLD) of 29 international units/mL (IU/mL).
A participant in Arm 2 with undetectable HCV-RNA at FW 24 had detectable HCV-RNA after FW 24. He is not considered to achieve SVR."|From follow-up week (FW) 24 up to end of follow-up (EOF)|Intent-to-Treat (ITT) population: All randomized participants who received at least one dose of any study medication (PegIntron, ribavirin, or boceprevir).||Participants|||Number
735159|NCT00423683|Secondary|Resolution of PE||3 years or until death|33 participants contributed 25 PE sites in Arm 1; 31 participants contributed 18 PE sites in Arm 2. Unit of analysis was PE sites||percentage of PE sites|Participants||Number
735160|NCT00423683|Secondary|Resolution of DVT||3 years or until death|33 participants contributed 59 DVT sites in Arm 1; 31 participants contributed 48 DVT sites in Arm 2. Unit of analysis was DVT sites||percentage of DVT sites|Participants||Number
735161|NCT00423683|Secondary|Overall Survival||3 years or until death|||days||95% Confidence Interval|Median
735162|NCT00423683|Primary|Adverse Outcomes|Rates of VCF complications, bleeding, and recurrent or residual DVTs or PEs|3 years or until death|||percentage of participants|||Number
735163|NCT00423722|Secondary|Change in Dehydration as Measured by Dehydration Assessment Scale|Dehydration was assessed by using the Dehydration Assessment Scale on the basis of three physical findings, moisture on the mucous membranes of the mouth (0=moist, 1=somewhat dry, 2=dry), axillary moisture (0=moist, 1=dry) and sunkenness of the eyes (0=normal, 1=slight sunken, 2=sunken). These signs are selected due to their significant correlations with biological dehydration, as previously confirmed by elderly patients. The dehydration score (range 0-7) is calculated as the total of these 3 scores, a higher score indicates a higher level of dehydration. The reported value was the mean of average change in patients' scores per group.|Baseline to Day 7|||units on a scale||Standard Deviation|Mean
735164|NCT00423722|Secondary|Reduced Symptom Burden (From Baseline to 7 Days Post Infusion)|Secondary outcomes included delirium, quality of life, and overall survival. The Nursing delirium screening scale (NuDESC) was used to assess delirium. NuDESC is a validated observational instrument conducted by research staff based on input from family caregivers. Five symptoms (disorientation, inappropriate behavior, inappropriate communication, illusions or hallucinations, and psychomotor retardation) are each given a score from 0 to 2, for a possible total score of 10. A higher NuDESC score indicates increased symptoms of delirium. It was observed a trend for lesser decline (delirium) in the hydration group, and significant worsening of night-time NuDESC scores in the placebo group.|Baseline to Day 7 (Daily assessments at 2 hours [+/- 3 hours] after the completion of 4-Hour infusion)|||units on a scale||Inter-Quartile Range|Mean
735165|NCT00423722|Secondary|Change in Quality of Life and Fatigue as Measured by FACIT-F and FACT-G From Baseline to Day 7|"Change between Day 7 to Baseline in FACIT-F (Functional Assessment of Chronic illness Therapy-Fatigue) & FACT-G (Functional Assessment of Cancer Therapy-General) scores. Participants rate quality of life using FACT-G consisting of 33 questions with 5 domains assessing physical and social, emotional & functional well being & relationship with physician, remaining 5 assess extent to which each domain affects overall quality of life on 5-point scale from 0 (not at all) to 4 (very much); total score obtained by summing individual subscale scores (0-132). FACIT-F consists of 13 items where participants rate intensity of fatigue & its related symptoms on a scale of 0-4 from 0 not at all to 4 very much. The responses to FACIT fatigue questionnaire are each measured on 4‐point Likert scale with total score ranges from 0 to 52. High scores represent less fatigue. Reported is the mean change of the summed value of all reported scores for the FACT-G or the FACIT-F from baseline to Day 7."|Baseline to Day 7|||units on a scale||Standard Deviation|Mean
735166|NCT00423722|Secondary|Reduced Symptom Burden as Measured by RASS, MDAS and UMRS|"Participants rated delirium, quality of life, and overall survival using Richmond agitation sedition scale (RASS) where +4 is Combative to -5 is Unarousable; Memorial delirium assessment scale (MDAS), a ten-item, clinician-rated scale from 0 (none) to 3 (severe) for severity of delirium, for a total range of 0-30; and Unified Myoclonus Rating Scale (UMRS) 5-functional scores rated 0 to 4, for a total range of 0-20 where higher scores indicate more severe involuntary movements. Higher scores indicate worse outcomes for each scale, i.e. RASS more agitation, MDAS more delirium and UMRS more severe involuntary movements. The mean represents change in combined participant daily scores for each scale between Baseline and Day 4 assessments then separately Day 7 assessments. Reported value is mean of average change in patients' scores per group. Reported values reflect changes from baseline, either median decreases (less than 0), no change (0) or increases (greater than 0)."|Baseline to Day 7|||units on a scale||Inter-Quartile Range|Median
736277|NCT00440271|Secondary|Occurrence of TPV Trough Concentration >120 μM||after 2 weeks of treatment (Weeks 2, 4, 8, 12, 24, 36, and 48)|The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.|||||
735167|NCT00423722|Primary|Participant Reduced Symptom Burden|Symptom burden, assessed using the Edmonton Symptom assessment scale, which has been validated in the cancer population. Participants are asked to rate the severity of their symptoms over the previous 24 hours using a numerical rating scale of 0-10, with 0 meaning that the symptom is absent and 10 meaning the worst possible symptom. The mean is a composite outcome where change in the sum of 4 dehydration symptoms (fatigue, myoclonus, sedation and hallucinations) between day 4 and baseline ranged from 0-40 daily. The reported value was the mean of average change in patients' scores per group.|From Baseline to 4 Days Later (Daily assessments at 2 hours [+/- 3 hours] after the completion of 4-Hour infusion)|||units on a scale||Standard Deviation|Mean
735168|NCT00423735|Secondary|Correlation of Pharmacokinetic Data With Dosing, Toxicity, and Efficacy|Sufficient pharmacokinetic data was not obtained.|Analysis occurs after all patients have been on study for at least 6 months. (Patients are followed from registration to death or study termination whichever occurs first.)||||||
735169|NCT00423735|Secondary|Correlation of Molecular Markers and Tumor Response|The following markers were examined: p-SRC, PDGFR, EPHA2, c-KIT. Patients were categorized based on the number of positive molecular markers they had: 2 vs. 3 and 4. Correlation of marker category and best tumor response was tested using Fisher’s exact test. The best tumor response is defined as the best radiographic response for patients evaluable for radiographic response prior to progression up to six months. Patients are combined from the two treatment arms.|From registration to 6 months|Eligible patients who started study treatment and whose response was assessed||Participants|||Count of Participants
735170|NCT00423735|Secondary|Rate of Adverse Events|The rate of patients' worst overall grade of adverse event is reported. Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. The study is not designed for a comparison of the treatment arms to each other.|Analysis occurs after all patients have been on study for at least 6 months. (Patients are followed from registration to death or study termination whichever occurs first.)|Eligible patients who started protocol treatment||percentage of participants|||Number
735171|NCT00423735|Secondary|Progression-free Survival|Progression-free survival time is measured from randomization to the date of first progression or death, else the last follow-up date on which the patient was reported alive, and is estimated by the Kaplan-Meier method. Progression is defined as ≥ 25% increase in the size of enhancing tumor or any new tumor, neurologically worse, or steroids stable/increased. The study is not designed for a comparison of the treatment arms to each other.|Analysis occurs after all patients have been on study for at least 6 months. (Patients are followed from registration to death or study termination whichever occurs first.)|Eligible patients who started study treatment||months||95% Confidence Interval|Mean
735172|NCT00423735|Secondary|Treatment Response Rates at Six Months|Best response is assessed using standard criteria for patients with malignant gliomas (Macdonald 1990) as reported by the site. Complete response (CR): Complete disappearance of all enhancing tumor on consecutive CT or MRI scans at least 1 month apart; off corticosteroids; neurologically stable/improved. Partial response (PR): ≥ 50% decrease in size of enhancing tumor on consecutive CT or MRI scans at least 1 month apart; corticosteroids stable/reduced; neurologically stable/improved. Stable disease (SD): Does not qualify for CR, PR, or PD. Progressive disease (PD): ≥ 25% increase in the size of enhancing tumor or any new tumor; neurologically worse; steroids stable/increased. The best tumor response is defined as the best radiographic response for patients evaluable for radiographic response prior to progression, up to six months. The study is not designed for a comparison of the treatment arms to each other.|From registration to 6 months|Eligible patients who started study treatment||percentage of participants|||Number
735173|NCT00423735|Secondary|Overall Survival|Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. The study is not designed for a comparison of the treatment arms to each other.|Analysis occurs after all patients have been on study for at least 6 months. (Patients are followed from registration to death or study termination whichever occurs first.)|Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. This analysis was planned to occur when all patients had been potentially followed for at least 6 months. Arms are not compared.||months||95% Confidence Interval|Median
735174|NCT00423735|Secondary|Number of Patients Achieving Objective Response (Partial or Complete Response) OR 6-month Progression-free Survival (6mPFS)|Study design and efficacy determination uses the hybrid endpoint of 6mPFS or complete/partial response of any duration prior to or at 6 months. Null hypothesis = 11%; alternative hypothesis = 25%. Simon’s minmax 2-stage design was used with type I and type II error both set at 10%. Stage 1 and 1B: If 2 or fewer patients were alive and progression-free at 6 months or achieved complete/partial response, then there would be no further accrual and the alternative hypothesis would be rejected. Otherwise accrual would continue to a total of 50 analyzable patients to address the primary endpoint. Complete Response: Complete disappearance of all enhancing tumor on consecutive CT or MRI scans at least 1 month apart; off corticosteroids; neurologically stable/improved. Partial Response: ≥ 50% decrease in size of enhancing tumor on consecutive CT or MRI scans at least 1 month apart; corticosteroids stable/reduced; neurologically stable/improved.|Registration to 6 months|Eligible patients who started protocol treatment.||participants|||Number
735175|NCT00423735|Primary|Number of Patients Achieving 6-month Progression-free Survival (6mPFS)|This study utilized a two-stage phase II design (Stage 1B and 2). The primary endpoint of 6-month progression-free survival (6mPFS) would be assessed based on the patients combined from 1B and 2 if the study continued to Stage 2. Null hypothesis = 11%; alternative hypothesis = 25%. Simon's minmax 2-stage design was used with type I and type II error both set at 10%. If the first stage met its criteria (see secondary outcome measure), then accrual would continue, otherwise there would be no further accrual and the alternative hypothesis would be rejected. Following Stage 2 accrual completion and 6 months of follow-up, if 9 or more patients were alive without progression by 6 months, the null hypothesis would be rejected in favor of the alternative.|Registration to 6 months|Eligible patients who started protocol treatment.||participants|||Number
735176|NCT00423800|Secondary|Number of Participants With a Virological Relapse|"Participants were tested for the presence of Hepatitis C Virus-Ribonucleic Acid (HCV-RNA) in blood by Qualitative Polymerase Chain Reaction (qPCR).
Virological relapse in participants was defined as having negative virology (HCV-RNA) at end of treatment, but positive virology (HCV-RNA) again at 24 weeks of follow up post treatment."|24 weeks following completion of 24 or 48 weeks of therapy|ITT population that completed the study.||Participants|||Number
735177|NCT00423800|Primary|Number of Participants With a Sustained Virologic Response|"Participants were tested for the presence of Hepatitis C Virus-Ribonucleic Acid (HCV-RNA) in blood by Qualitative Polymerase Chain Reaction (qPCR). If the HCV-RNA is not detectable, the participant is negative for HCV-RNA.
Sustained virologic responders were participants negative for HCV-RNA at 24 weeks following the completion of therapy. A Participant that withdrew prior to 24 weeks following the completion of therapy was considered a non-responder."|24 weeks following completion of 24 or 48 weeks of therapy|||Participants|||Number
735178|NCT00423813|Primary|Pain VAS (Visual Analog Scale) Response. Percentage of Subjects With a Greater Than or Equal to 30% Reduction in Pain VAS From Baseline (BOCF).|Percentage of pain VAS responders. Subjects with a >= 30% reduction in pain VAS from baseline to endpoint (week 14) were considered responders; all other subjects were considered non-responders. Missing data were handled using BOCF (Baseline Observation Carried Forward). The pain VAS ranges from 0 (no pain) to 100 (worst imaginable pain). The pain VAS was collected morning, afternoon and evening. Baseline is the average value recorded for the measure during the week prior to the end-of-baseline visit. Endpoint is the average value recorded for the measure during the week prior to week 14.|Baseline to Week 14|||Percentage of Participants|||Number
735179|NCT00429663|Secondary|Valgus of Over 5 Degrees|Valgus is a deformity involving oblique displacement of part of a limb away from the midline.|12 months|160 subjects were enrolled, but due to patient withdrawal or incomplete data from sites, only 126 subjects were followed.||participants|||Number
735180|NCT00429663|Primary|SMFA - Bother Index|The Bother Index is part of the SMFA. This section focuses on how much the injury is bothering the subject in terms of daily activities and use of injured area. The index totals are between 0-100. The lower the score, the less bothered the subject is by their injury.|3 months, 6 months, 12 months|160 subjects were enrolled, but due to patient withdrawal or incomplete data from sites, only 126 subjects were followed.||units on a scale||Standard Deviation|Mean
735181|NCT00429663|Primary|EQ Index|EQ Index is a visual analog scale that the subject uses to rank overall health and wellness on a scale of 0.00-1.00, 1.00 being best.|3 months, 6 months, 12 months|160 subjects were enrolled, but due to patient withdrawal or incomplete data from sites, only 126 subjects were followed.||units on a scale||Standard Deviation|Mean
735182|NCT00429663|Primary|Short Musculoskeletal Functional Assessment (SMFA) Score|The Short Musculoskeletal Functional Assessment (SMFA) score. The questionnaire consists of four categories: Daily Activities, Emotional Status, Arm and Hand Function, Mobility. All categories are scored together, totaling between 0-100. The lower the score, the better the subjects function.|3 months, 6 months, 12 months|160 subjects were enrolled, but due to patient withdrawal or incomplete data from sites, only 126 subjects entered were followed.||units on a scale||Standard Deviation|Mean
735183|NCT00429663|Primary|EQ-5D|EQ-5D (EuroQol) Health Index taken at 3 months, 6 months, 12 months follow up. The EQ-5D measures the subjects health status in 5 categories (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and totals them into 1 score. Scoring ranges from 0-100, 100 being best.|3 months, 6 months, 12 months|160 subjects were enrolled, but due to patient withdrawal or incomplete data from sites, only 126 subjects were followed.||units on a scale||Standard Deviation|Mean
735184|NCT00429702|Secondary|Proportion of Patients Requiring Rescue Medication for Breakthrough Nausea or Emesis After Completion of the First Course of Emetogenic Chemotherapy|CINV will be determined based on the number of rescue medications used during the 3 days following completion of chemotherapy cycle. Rescue medication is any medication administered by the treating team to control breakthrough nausea or emesis. Rescue medications were used to treat any patient who has enough symptoms requiring additional therapy. All patients were instructed to first use the push button on the pump. On-demand administration of study agent via the patient-controlled infusion pump will not be considered rescue therapy – it is part of the antiemetic treatment regimen. If on-demand administration is not successful in controlling the patient’s symptoms, then as-needed rescue medications are to be administered. The treating staff will administer additional (as needed) doses of intravenous antiemetics, depending on the institutional preference.|3 days of following completion of first chemotherapy cycle|||participants|||Number
735185|NCT00429702|Primary|Proportion of Patients Requiring Rescue Medication for Breakthrough Nausea or Emesis During Inpatient Chemotherapy|Rescue medication is any medication administered by the treating team to control breakthrough nausea or emesis. Rescue medications were used to treat any patient who has enough symptoms requiring additional therapy. All patients were instructed to first use the push button on the pump. On-demand administration of study agent via the patient-controlled infusion pump will not be considered rescue therapy – it is part of the antiemetic treatment regimen. If on-demand administration is not successful in controlling the patient’s symptoms, then as-needed rescue medications are to be administered. The treating staff will administer additional (as needed) doses of intravenous antiemetics, depending on the institutional preference.|during in-patient cycle of chemotherapy, up to 4 days|||participants|||Number
735186|NCT00429793|Other Pre-specified|Patient Vital Status|Patients alive or dead after 24 months from time of study entry|Study entry up to 2 years|||participants|||Number
735187|NCT00429793|Other Pre-specified|Reason Off Study Therapy||from study entry until end of study treatment|||participants|||Number
735188|NCT00429793|Secondary|Duration of Overall Survival|Characterized with Kaplan-Meier plots and estimates of the median time until death or progression.|Up to 5 years||||||
735189|NCT00429793|Secondary|Duration of PFS|Characterized with Kaplan-Meier plots and estimates of the median time until death or progression.|Up to 6 months||||||
735190|NCT00429793|Primary|Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0)||Up to 5 years||||||
735313|NCT00434356|Secondary|Grade ≥ 3 Adverse Events (AEs)|All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0. Grading: 1=Mild AE; 2=Moderate AE; 3=Severe AE; 4=Life-threatening or disabling AE; 5=Death related to AE|30 days following the last administration of study treatment|Treated patients||participants|||Number
735191|NCT00429793|Primary|Objective Tumor Response Based on the Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) Criteria|Number of participants who experienced an objective tumor response up to 5 years. Per RECIST version 1.0 criteria: each target lesion must be >= 20 mm when measured by conventional techniques, including palpation, plain x-ray, CT, and MRI, or >= 10 mm when measured by spiral CT. Complete Response is a disappearance of all target and non-target lesions. Partial Response is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions, taking as reference the baseline sum of LD. Increasing Disease is at least a 20% increase in the sum of LD of target lesions, taking as references the smallest sum LD or the appearance of new lesions.|Up to 5 years|||participants|||Number
735192|NCT00429793|Primary|6 Month Progression-free Survival (PFS)|Number of participants who survived progression-free for more than 6 months.|6 months|||participants|||Number
735193|NCT00429923|Primary|"Anterior Chamber Cell Grade of 0 on Day 8 (Difluprednate QID vs Placebo)."|Measured on a 0 to 4 scale: “0” is ≤ 1 cell; “1” is 2-10 cells; “2” is 11-20 cells; “3” is 21-50 cells; “4” is > 50 cells.|Day 8 (QID)|The ITT population was defined as all randomized subjects who received at least 1 administration of the study drug. Analysis of the ITT population, with LOCF for missing data, was conducted for all primary and secondary endpoints at Days 3, 8, 15, and 29.||participants|||Number
735194|NCT00429949|Secondary|Event-free Survival (EFS) for Participants With Relapsed Disease|EFS is defined as time from the start of the treatment until the first date that criteria for progressive disease are met, therapy was discontinued for toxicity, or death, whichever occurs first. Those patients alive will be censored at the date of last clinical contact. If progression is based upon serum or urine paraprotein measurements, which must be repeated for confirmation, event-free progression is still measured from the start of treatment until the first date that progression is detected.|Completion of treatment (median duration of therapy was 51 days)|||days||95% Confidence Interval|Median
735195|NCT00429949|Secondary|Event-free Survival (EFS) for Participants With Plateau Phase Disease|EFS is defined as time from the start of the treatment until the first date that criteria for progressive disease are met, therapy was discontinued for toxicity, or death, whichever occurs first. Those patients alive will be censored at the date of last clinical contact. If progression is based upon serum or urine paraprotein measurements, which must be repeated for confirmation, event-free progression is still measured from the start of treatment until the first date that progression is detected.|Completion of treatment (median duration of therapy was 51 days)|||days||95% Confidence Interval|Median
735196|NCT00429949|Secondary|Duration of Response|Duration of response is measured from the first date that criteria are met for complete response or partial response until the first date that criteria for relapse or progressive disease are met.|Completion of treatment (median duration of therapy was 51 days)|Only one patient achieved a partial response.||cycles|||Number
735197|NCT00429949|Secondary|Safety and Tolerability of Dasatinib (Grade III-IV Toxicities)|Toxicities were graded using the NCI Common Toxicity Criteria v3.0.|Up to 30 days following end of treatment (median duration of therapy was 51 days)|||participants|||Number
735198|NCT00429949|Secondary|Time to Response|Time to response is measured from the start of treatment until the first date that criteria are met for complete response or partial response.|Completion of treatment (median duration of therapy was 51 days)|Only one patient achieved a partial response.||cycles|||Number
735199|NCT00429949|Primary|Response Rate [Complete Response (CR) and Partial Response (PR)]|"CR requires all of the following:
Absence of the original monoclonal paraprotein in serum and urine by immunofixation, maintained for a minimum of 6 weeks. The presence of oligoclonal bands consistent with oligoclonal immune response reconstitution does not exclude CR.
< 5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy, if biopsy is performed. If absence of monoclonal protein is sustained for 6 weeks it is not necessary to repeat the bone marrow.
No increase in the size or number of lytic bone lesions (development of a compression fracture does not exclude response).
Disappearance of soft tissue plasmacytoma
PR requires all of the following:
50% reduction in the level of the serum monoclonal paraprotein maintained for a minimum of 6 weeks.
-Reduction in 24 hr urinary light chain excretion by either > 90% or to < 200 mg, maintained for a minimum of 6 weeks.
50% reduction in the size of soft tissue plas"|Completion of treatment (median duration of therapy was 51 days)|||participants|||Number
735200|NCT00433914|Secondary|Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ|Safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 through day 7 after each vaccination of rMenB vaccine with and without OMV-NZ administered at 6-8 months (vaccination 1), 2 months later (vaccination 2) and at 12 months (vaccination 3).|Day 1 through day 7 after each vaccination|Analysis was performed on the safety set, i.e. all subjects in the exposed population who provided post-baseline safety data.||Number of subjects|||Number
735201|NCT00433914|Secondary|Percentage of Subjects With Four-fold Rise in ELISA Concentration Against Meningococcal 287-953 Antigen One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ|Immunogenicity was measured as the percentage of subjects who achieved a four-fold increase in ELISA geometric mean concentrations against meningococcal 287-953 antigen, one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age).|One month after second and third vaccination|Analysis was performed on the per protocol (PP) population set.||Percentage of subjects||95% Confidence Interval|Number
735202|NCT00433914|Secondary|Geometric Mean ELISA Concentration Against Meningococcal 287-953 Antigen One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ|The immune response was measured as the geometric mean concentrations (GMCs) against the meningococcal antigen 287-953, evaluated using enzyme-linked immunosorbent assay (ELISA), before vaccination (baseline) and one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age).|Baseline and one month after second and third vaccination|Analysis was performed on the per protocol (PP) population set.||µg/mL||95% Confidence Interval|Geometric Mean
735283|NCT00434304|Secondary|Change From Baseline in Total Bilirubin, Blood Urea Nitrogen, and Creatinine at Weeks 16 and 52|Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.|Baseline (Screening) and Weeks 16 and 52|Safety Population: all participants who received at least one dose of study medication. Week 16 (Last observation carried forward [LOCF]) = 62 participants; Week 52 (Observed case [OC]) = 44 participants||micromoles per Liter (UMOL/L)||Standard Deviation|Mean
735203|NCT00433914|Secondary|Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ|The immune response was measured as the geometric mean bactericidal titers directed against meningococcal strains 44/76-SL, 5/99, NZ98/254 (major strains), UK P1.7-2,4, GB101, GB355 and GB364 (additional strains), before vaccination (baseline) and one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age).|Baseline and one month after second and third vaccination|Analysis was performed on the per protocol (PP) population set.||Geometric mean titers||95% Confidence Interval|Geometric Mean
735204|NCT00433914|Secondary|Percentage of Subjects With Four-fold Rise in Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ|Immunogenicity was measured as the percentage of subjects who achieved a four-fold increase in bactericidal titers against meningococcal strains 44/76-SL, 5/99, NZ98/254 (major strains), UK P1.7-2,4, GB101, GB355 and GB364 (additional strains), one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age).|One month after second and third vaccination|Analysis was performed on the per protocol (PP) population set.||Percentage of subjects||95% Confidence Interval|Number
735205|NCT00433914|Primary|Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ|Immunogenicity was measured as the percentage of subjects who achieved bactericidal titers ≥1:8 against meningococcal strains 44/76-SL, 5/99, NZ98/254 (major strains), UK P1.7-2,4, GB101, GB355 and GB364 (additional strains), before vaccination (baseline) and one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age).|Baseline and one month after second and third vaccination|Analysis was performed on the per protocol (PP) population set.||Percentage of subjects||95% Confidence Interval|Number
735206|NCT00433914|Primary|Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ|Immunogenicity was measured as the percentage of subjects who achieved bactericidal titers ≥1:4 against meningococcal strains 44/76-SL, 5/99, NZ98/254 (major strains), UK P1.7-2,4, GB101, GB355 and GB364 (additional strains), evaluated using serum bactericidal assay, before vaccination (baseline) and one month after second vaccination (2 months later after vaccination at 6-8 months of age) and third vaccination (at 12 months of age).|Baseline and one month after second and third vaccination|Analysis was performed on the per protocol (PP) population set, i.e. all subjects in the enrolled population who received all the relevant doses of vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violation as defined prior to analysis.||Percentage of subjects||95% Confidence Interval|Number
735207|NCT00433992|Secondary|Change in Fat Apoptosis|Changes in limb fat from 0 to 48 weeks measured with whole-body dual-energy x-ray absorptiometry|Entry, Week 48|||g||Inter-Quartile Range|Median
735208|NCT00433992|Primary|Change in Mitochondrial Activity|mtDNA content in adipose tissue was measured by quantitative real-time polymerase chain-reaction.|Entry, Week 96|||copies/cell||Inter-Quartile Range|Median
735209|NCT00434018|Secondary|Craig Handicap Assessment and Reporting Technique (CHART): Economic Self-Sufficiency Subscale|Use as a measure of handicap that captures the interaction of the person and the environment, and of community reintegration and participation. The CHART quantifies handicap by evaluating five domains: physical independence, mobility, occupation, social integration, and economic self-sufficiency. The CHART is made up of 27 questions with responses that are countable or in a yes/no format. Each of the five subscales has a maximum score of 100, and they may be summed to form a total score. High scores indicate lesser handicap. The CHART was developed as a specific instrument to measure handicap, is the only measure of that concept validated specifically for persons with SCI, and is currently the most widely used measure related to community reintegration in SCI. The Economic Self-Sufficiency subscale measures the ability to sustain customary socio-economic activity and independence.|long term (1 year)|||units on a scale||Standard Deviation|Mean
735210|NCT00434018|Secondary|Craig Handicap Assessment and Reporting Technique (CHART): Social Integration Subscale|Use as a measure of handicap that captures the interaction of the person and the environment, and of community reintegration and participation. The CHART quantifies handicap by evaluating five domains: physical independence, mobility, occupation, social integration, and economic self-sufficiency. The CHART is made up of 27 questions with responses that are countable or in a yes/no format. Each of the five subscales has a maximum score of 100, and they may be summed to form a total score. High scores indicate lesser handicap. The CHART was developed as a specific instrument to measure handicap, is the only measure of that concept validated specifically for persons with SCI, and is currently the most widely used measure related to community reintegration in SCI. The Social Integration Subscale measures the ability to participate in and maintain customary social relationships.|long term (1 year)|||units on a scale||Standard Deviation|Mean
735211|NCT00434018|Secondary|Craig Handicap Assessment and Reporting Technique (CHART): Occupation Subscale|Use as a measure of handicap that captures the interaction of the person and the environment, and of community reintegration and participation. The CHART quantifies handicap by evaluating five domains: physical independence, mobility, occupation, social integration, and economic self-sufficiency. The CHART is made up of 27 questions with responses that are countable or in a yes/no format. Each of the five subscales has a maximum score of 100, and they may be summed to form a total score. High scores indicate lesser handicap. The CHART was developed as a specific instrument to measure handicap, is the only measure of that concept validated specifically for persons with SCI, and is currently the most widely used measure related to community reintegration in SCI. The Occupation Subscale measures the ability to occupy time in the manner customary to that person's sex, age, and culture.|long term (1 year)|||units on a scale||Standard Deviation|Mean
735236|NCT00434148|Secondary|Percent Change From Baseline in Mean Adrenocorticotropic Hormone (ACTH)|Blood samples were drawn to obtain ACTH levels. A negative change from baseline indicates improvement.|baseline, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78 months|Only participants from the full analysis set, who had measurements at baseline and the post baseline time point, were included in the analysis for that post baseline time point. The full analysis set included all randomized participants who received at least one dose of study drug.||percent change||Standard Deviation|Mean
735212|NCT00434018|Secondary|Craig Handicap Assessment and Reporting Technique (CHART): Mobility Subscale|Use as a measure of handicap that captures the interaction of the person and the environment, and of community reintegration and participation. The CHART quantifies handicap by evaluating five domains: physical independence, mobility, occupation, social integration, and economic self-sufficiency. The CHART is made up of 27 questions with responses that are countable or in a yes/no format. Each of the five subscales has a maximum score of 100, and they may be summed to form a total score. High scores indicate lesser handicap. The CHART was developed as a specific instrument to measure handicap, is the only measure of that concept validated specifically for persons with SCI, and is currently the most widely used measure related to community reintegration in SCI. The Mobility Subscale measures the ability to move about effectively in his/her surroundings.|long term (1 year)|||units on a scale||Standard Deviation|Mean
735213|NCT00434018|Secondary|Craig Handicap Assessment and Reporting Technique (CHART): Physical Independence Subscale|Use as a measure of handicap that captures the interaction of the person and the environment, and of community reintegration and participation. The CHART quantifies handicap by evaluating five domains: physical independence, mobility, occupation, social integration, and economic self-sufficiency. The CHART is made up of 27 questions with responses that are countable or in a yes/no format. Each of the five subscales has a maximum score of 100, and they may be summed to form a total score. High scores indicate lesser handicap. The CHART was developed as a specific instrument to measure handicap, is the only measure of that concept validated specifically for persons with SCI, and is currently the most widely used measure related to community reintegration in SCI. The Physical Independence subscale measures the ability to sustain a customarily effective independent existence.|long term (1 year)|||units on a scale||Standard Deviation|Mean
735214|NCT00434018|Primary|Wheelchair Skills Test (WST)|The WST is a standardized evaluation method that permits a set of representative wheelchair skills to be objectively, simply and inexpensively documented. The WST is an instrument for the objective evaluation of wheelchair skills. The WST consists of a series of commonly used wheelchair skills spanning the spectrum from those as basic as applying brakes to those as difficult as climbing curbs and performing wheelies. The WSC encompasses 57 skills (in Version 4.1) which result in a total score. The WST provide a pass-fail score for each skill. Refusal to attempt a skill (e.g. because of fear) constitutes a failing grade. The numerator is the Total Raw Score (i.e., the number of individual skills awarded a passing score) and the denominator is the number of applicable skills (i.e., the total number of skills minus those awarded NP scores). 100% is the maximum possible percentage score.|long term (1 year)|||units on a scale||Standard Deviation|Mean
735215|NCT00434057|Secondary|Exploratory Analyses||Within 365 days of Data Lock||02/2010||||
735216|NCT00434057|Secondary|Biopsy Ratio|Number of lesions bioopsied to melanomas detected|Within 120 days of Data Lock||12/2009||||
735217|NCT00434057|Primary|Sensitivity and Specificity|Sensitivity is the fraction of correctly identified cases of melanoma. Specificity is the fraction of correctly identified cases of non-melanoma.|Within 120 days of Data Lock|All participants with eligible and evaluable lesions were used in analysis of primary outcome measures||Ratio * 100||95% Confidence Interval|Mean
735218|NCT00434109|Secondary|Percentage of Participants With Overall Survival (OS) at 4 Years|Participant overall survival at 48 months. OS was defined as time from start of treatment until death as a result of any cause, with patients censored at the date of last follow-up if still alive.|48 months|All Participants||percentage of participants||95% Confidence Interval|Number
735219|NCT00434109|Secondary|Number of Participants Requiring Dose Reduction|Treatment related toxicity. Participants requiring dose reductions of sunitinib to 25 mg due to side effects.|12 months|All participants||participants|||Number
735220|NCT00434109|Secondary|Number of Participants With Biochemical Response|Biochemical response rate (>50% reduction in tumor marker). Response and progression endpoints refer specifically to hepatic metastases.|12 months|All Participants||participants|||Number
735221|NCT00434109|Secondary|Number of Participants With Partial Radiographic Response|Objective radiographic response rate. Response and progression endpoints refer specifically to hepatic metastases. Extrahepatic metastases were included for assessment of response and progression by RECIST version 1.0. Partial Response (PR): At least a 30% decrease in the sum of longest diameter (SLD) of target lesions, taking as reference the baseline SLD.|12 months|All Participants||participants|||Number
735222|NCT00434109|Secondary|Percentage of Participants With Overall Survival (OS) at One Year|Overall survival at 12 months. OS was defined as time from start of treatment until death as a result of any cause, with patients censored at the date of last follow-up if still alive.|12 months|All participants||percentage of participants||95% Confidence Interval|Number
735223|NCT00434109|Primary|Percentage of Participants With Progression Free Survival (PFS) at 12 Months|Kaplan-Meier analysis of PFS. Progression-free survival rate at 12 months after first embolization. PFS was defined as time from start of treatment until disease progression or death as a result of any cause. Response and progression endpoints refer specifically to hepatic metastases. Extrahepatic metastases were included for assessment of response and progression by RECIST version 1.0. Progressive Disease (PD): At least a 20% increase in the SLD of target lesions, taking as reference the smallest SLD recorded since the treatment started.|12 months|All participants||percentage of participants||95% Confidence Interval|Number
735224|NCT00434122|Secondary|Frequency of Oocyte Donors With Adequate Secretory Transformation at the Endometrial Histology Evaluation 7 Days After Injection With Human Chorionic Gonadotrophin (hCG)|An adequate secretory endometrium 7 days after hCG injection was defined as secretory in the histological classification and with endometrial dating corresponding to the expected cycle day ±1 day.|7 days after hCG injection|Subjects with evaluable endometrial biopsies 7 days after injection with hCG.||Participants|||Number
735225|NCT00434122|Primary|Coefficient of Variation of Follicular Sizes on Stimulation Day 1 (Follicles ≥ 2 mm)|"Explanation of the term coefficient of variation: The coefficient of variation is a normalized measure of dispersion of a probability distribution."|Stimulation Day 1|||Percentage||Standard Deviation|Mean
735281|NCT00434304|Secondary|Change From Baseline in Prolactin at Weeks 16 and 52|Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.|Baseline (Screening) and Weeks 16 and 52|Safety Population: all participants who received at least one dose of study medication. Week 16 (Last observation carried forward [LOCF]) = 62 participants; Week 52 (Observed case [OC]) = 44 participants||micrograms per Liter (MCG/L)||Standard Deviation|Mean
735226|NCT00434148|Secondary|Percentage Change From Baseline in Health Related Quality of Life (HRQL) Score|A Cushing's syndrome health related quality of life (HRQL) questionnaire was completed. The Cushing’s Syndrome HRQL questionnaire contains 12 sentences with 5 possible answers each. The answers are based on Likert scales, with 5 response categories: Always, Often, Sometimes, Rarely and Never; or Very much, Quite a bit, Somewhat, Very little, and Not at all. The answers to each of the items are rated on a scale of 1 to 5. “1” corresponds to the response category “Always” or “Very much” and “5” corresponds to the category “Never” or “Not at all”. The score is the sum of all item responses and can range from 12 to 60 points. The lower the score, the greater the Cushing's Syndrome impacts on HRQoL. A positive change from baseline indicates improvement.|baseline, 3 months, 6 months, 12 months|Only participants from the full analysis set, who had measurements at baseline and the post baseline time point, were included in the analysis for that post baseline time point. The full analysis set included all randomized participants who received at least one dose of study drug.||Percentage change in HRQL score||Standard Deviation|Mean
735227|NCT00434148|Secondary|Change From Baseline in Tumor Volume|Pituitary magnetic resonance imaging (MRI) was performed to determine tumor volume. A negative change from baseline indicates imrpovement.|baseline, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78 months|Only participants from the full analysis set, who had measurements at baseline and the post baseline time point, were included in the analysis for that post baseline time point. The full analysis set included all randomized participants who received at least one dose of study drug.||cm^3||Standard Deviation|Mean
735228|NCT00434148|Secondary|Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Body Composition|Body composition as in percentage of body fat by region was assessed by total body scan. A negative change from baseline indicates improvement.|baseline, month 3, month 6, month 12, month 24, month 36, month 48, month 60|Only participants from the full analysis set, who had measurements at baseline and the post baseline time point, were included in the analysis for that post baseline time point. The full analysis set included all randomized participants who received at least one dose of study drug.||Percentage of body fat||Standard Deviation|Mean
735229|NCT00434148|Secondary|Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Bone Mineral Density (BMD)|BMD was measured using Lunar or Hologic dual-energy X-ray absorptiometry (DXA) Instruments. Measurements were done in the lumbar vertebrae (L1-L4), proximal femur (total hip) and proximal femur (femur neck). A negative change from baseline indicates imrpovement.|baseline, month 3, month 6, month 12, month 24, month 36, month 48, month 60|Only participants from the full analysis set, who had measurements at baseline and the post baseline time point, were included in the analysis for that post baseline time point. The full analysis set included all randomized participants who received at least one dose of study drug.||mg/cm^3||Standard Deviation|Mean
735230|NCT00434148|Secondary|Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Ferriman-Galway Hirsutism Score|The Ferriman Gallwey scoring system is used to score the degree of excess male pattern body hair. The scorecard of every body location under survey begins from 0 (no excessive terminal hair growth) to 4 (extensive terminal hair growth) and the numbers are added up to a maximum count of 36. A score >= 6 indicates the hirsutism. A negative change from baseline indicates imrpovement.|baseline, month 3, month 6, month 12, month 24, month 36, month 48, month 60|||score on a scale||Standard Deviation|Mean
735231|NCT00434148|Secondary|Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Beck Depression Inventory (BDI-II) Score|"The BDI-II is a 21 item self-report rating inventory measuring characteristic attitudes and symptoms of depression. The BDI-II contains 21 questions, each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms. The scores range as follows:
0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression; and 29-63: severe depression. A negative change from baseline indicates imrpovement."|baseline, month 3, month 6, month 12, month 18, month 24|Only participants from the full analysis set, who had measurements at baseline and the post baseline time point, were included in the analysis for that post baseline time point. The full analysis set included all randomized participants who received at least one dose of study drug.||score on a scale||Standard Deviation|Mean
735232|NCT00434148|Secondary|Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Total Cholesterol and Triglycerides|Blood samples were drawn to obtain total cholesterol and triglycerides' levels. A negative change from baseline indicates improvement.|baseline, month 3, month 6, month 12, month 24, month 36, month 48, month 60|Only participants from the full analysis set, who had measurements at baseline and the post baseline time point, were included in the analysis for that post baseline time point. The full analysis set included all randomized participants who received at least one dose of study drug.||mmol/L||Standard Deviation|Mean
735233|NCT00434148|Secondary|Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Waist Circumference|Waist circumference was measured with a measuring tape correctly positioned. A negative change from baseline indicates improvement.|baseline, month 3, month 6, month 12, month 24, month 36, month 48, month 60|Only participants from the full analysis set, who had measurements at baseline and the post baseline time point, were included in the analysis for that post baseline time point. The full analysis set included all randomized participants who received at least one dose of study drug.||cm||Standard Deviation|Mean
735234|NCT00434148|Secondary|Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Body Mass Index (BMI)|BMI was determined by using height and weight measurements. A negative change from baseline indicates improvement.|baseline, month 3, month 6, month 12, month 24, month 36, month 48 and month 60|Only participants from the full analysis set, who had measurements at baseline and the post baseline time point, were included in the analysis for that post baseline time point. The full analysis set included all randomized participants who received at least one dose of study drug.||kg/m^2||Standard Deviation|Mean
735235|NCT00434148|Secondary|Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Sitting Sytolic Blood Pressure (SBP) and Sitting Diastolic Blood Pressure (DBP)|Sitting blood pressure assessments were performed at every study visit. A negative change from baseline indicates improvement.|baseline, month 3, month 6, month 12, month 24, month 36, month 48, month 60|Only participants from the full analysis set, who had measurements at baseline and the post baseline time point, were included in the analysis for that post baseline time point. The full analysis set included all randomized participants who received at least one dose of study drug.||mmHg||Standard Deviation|Mean
735237|NCT00434148|Secondary|Percent Change From Baseline in Serum Cortisol|Blood samlpes were drawn to obtain serum cortisol levels. A negative change from baseline indicates improvement.|baseline, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78 months|Only participants from the full analysis set, who had measurements at baseline and the post baseline time point, were included in the analysis for that post baseline time point. The full analysis set included all randomized participants who received at least one dose of study drug.||Percent change||Standard Deviation|Mean
735238|NCT00434148|Secondary|Time to First UFC Response|Time to first UFC response is defined as the number of months from baseline to first attainment of UFC response.|12 months|Full Analysis Set (FAS): The full analysis set included all randomized participants who received at least one dose of study drug.||months||Inter-Quartile Range|Median
735239|NCT00434148|Secondary|Change From Baseline in mUFC|Twenty four hour urine samples were collected to obtain mUFC measurements. A negative change from baseline indicates improvement.|baseline, 3 months, 12 months|Only participants from the full analysis set, who had measurements at baseline and the post baseline time point, were included in the analysis for that post baseline time point. The full analysis set included all randomized participants who received at least one dose of study drug.||nmol/24h||Standard Deviation|Mean
735240|NCT00434148|Primary|Number of mUFC (Urinary Free Cortisol) Responders by Randomized Dose Group|A responder in the primary efficacy analysis was a patient with a mUFC≤ULN at Month 6 and whose dose was not increased prior to Month 6.|6 months|The full analysis set (FAS) was the primary population for efficacy and consisted of all 162 randomized patients who received at least one dose of paseriotide.||Responders||95% Confidence Interval|Number
735241|NCT00434161|Secondary|Incidence of Second Primary Malignancies or Other Malignancies|All comparisons for the long-term safety endpoints were based on the combined palifermin group versus placebo (placebo over palifermin). Incidence of new or secondary malignancies by treatment group was provided (incidence of new or secondary malignancies at the follow-up visit – yes, no, no assessment –, and number of subjects with new or secondary malignancies, per type of malignancies). The long-term safety evaluations were summarized for the subgroups defined by the factors used for randomization using descriptive statistics.|During long-term follow up phase (maximum of 10 years)|total of 277 subjects were included in the Safety subset of the original study report (220 Palifermin and 57 placebo). Follow-up time for all subjects, defined as the date of randomization to the last known alive date. For subjects who were alive at the last contact the number of subjects for the palifermin group was 162 and for the placebo 47.||participants|||Number
735242|NCT00434161|Secondary|Time Death or Disease Progression|For the analysis of time to disease progression, competing risks time-to-event analysis was used, since a subject destined to develop disease progression could die from unrelated causes before the disease progression event takes place. Kaplan-Meier survival estimates, with death due to other causes than progression considered as a competing risk, were provided: event rate at 3 month intervals, with 95% confidence interval, the number of subjects at risk at the beginning of the time period, and the number of events of interest.|During long-term follow up phase (maximum of 10 years)|A total of 277 subjects were included in the Safety subset of the original study report (220 Palifermin and 57 placebo). Follow-up time for all subjects, defined as the date of randomization to the last known alive date. For subjects who were alive at the last contact the number of subjects for the palifermin group was 162 and for the placebo 47.||months||Inter-Quartile Range|Median
735243|NCT00434161|Secondary|Progression Free Survival|Progression-free survival (PFS) is the length of time during and after the treatment during which the disease being treated does not get worse. In this study the event for Progression-free survival was death from all causes or disease progression. Time to each event was defined as the time elapsed between the date of the first dose of investigational product, and the date of the given event.|During long-term follow up phase (maximum of 10 years)|A total of 277 subjects were included in the Safety subset of the original study report (220 Palifermin and 57 placebo). Follow-up time for all subjects, defined as the date of randomization to the last known alive date. For subjects who were alive at the last contact the number of subjects for the palifermin group was 162 and for the placebo 47.||Months||Inter-Quartile Range|Median
735244|NCT00434161|Primary|Incidence of Cataract Development or Progression at Month 12.|Number of participants from the primary cataract subset showing an increase from baseline of >= 0.3 in the Lens Opacities Classification System III (LOCS III score). The LOCS III is a standard system used for grading and comparison of cataract severity and type. The ophthalmologist trained in LOCS III uses a slit lamp for examining the lens of the eye. The classification evaluates four features: posterior subcapsular cataract(P),cortical cataract(C),nuclear opalescence(NO) and nuclear color(NC). NO and NC are graded on a decimal scale of 0.1 to 6.9, based on a set of 6 standardized photographs. C and P are graded on a decimal scale of 0.1 to 5.9, based on a set of 5 standardized photographs each. In the current study, cataract development or progression was defined as an increase from baseline of ≥ 0.3 on any of the three features P, C or NO (NC is of less importance and has not been analysed further in this study).|12 months|Of the 281 subjects who participated in the acute phase of the study a total of 101 subjects study were eligible for participation in the cataract assessment procedures, 22 in the placebo group and 79 in the palifermin group.||Participants|||Number
735245|NCT00434161|Secondary|Overall Survival|Overall survival (OS) is based on death from any cause, not just the condition being treated, thus it picks up death from side effects of the treatment, and effects on survival after relapse.|During long-term follow up phase (maximum of 10 years)|A total of 277 subjects were included in the Safety subset of the original study report (220 Palifermin and 57 placebo). Follow-up time for all subjects, defined as the date of randomization to the last known alive date. For subjects who were alive at the last contact the number of subjects for the palifermin group was 162 and for the placebo 47||Months||Inter-Quartile Range|Median
735246|NCT00434161|Secondary|Incidence of Adverse Events and Laboratory Abnormalities|Incidence of Adverse Events CTCAE grade 3 or higher reported|at Day 32|||Participants|||Number
735282|NCT00434304|Secondary|Change From Baseline in Blood Urea Nitrogen, Cholesterol, Chloride, Potassium, and Sodium at Weeks 16 and 52|Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.|Baseline (Screening) and Weeks 16 and 52|Safety Population: all participants who received at least one dose of study medication. Week 16 (Last observation carried forward [LOCF]) = 62 participants; Week 52 (Observed case [OC]) = 44 participants||millimoles per Liter (MMOL/L)||Standard Deviation|Mean
735247|NCT00434161|Secondary|Incidence of a Decreased From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by a Change of 10 Letters on the ETDRS (Early Termination Diabetic Retinopathy Study) at 4 Meters at Months 12.|To study if the treatment has effected on the visual acuity from baseline to months 12, by using Best Corrected Visual Acuity (BCVA) as measured by a Change of 10 Letters on the ETDRS (Early Termination Diabetic Retinopathy Study) at 4 Meters. To assess the effect of palifermin on the incidence of cataract development or progression at Month 6 and Month 12 based on an increase of ≥ 0.3 in the Lens Opacities Classification System (LOCS III) score for Posterior Subcapsular cataract (P), Cortical Cataract (C) and Nuclear Opalescence (NO).|Month 12|All subjects in the acute phase study were also assessed for their eligibility for cataract assessment procedures according to predefined criteria. If a subject was not eligible for cataract assessment procedures, the subject could still have been eligible for inclusion in the study but was exempt from the cataract assessments.||participants|||Number
735248|NCT00434161|Secondary|Incidence of a Decreased From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by a Change of 10 Letters on the ETDRS (Early Termination Diabetic Retinopathy Study) at 4 Meters at Months 6|To study if the treatment has effected on the visual acuity from baseline to months 6, by using Best Corrected Visual Acuity (BCVA) as measured by a Change of 10 Letters on the ETDRS (Early Termination Diabetic Retinopathy Study) at 4 Meters. To assess the effect of palifermin on the incidence of cataract development or progression at Month 6 and Month 12 based on an increase of ≥ 0.3 in the Lens Opacities Classification System (LOCS III) score for Posterior Subcapsular cataract (P), Cortical Cataract (C) and Nuclear Opalescence (NO).|Months 6|All subjects in the acute phase study were also assessed for their eligibility for cataract assessment procedures according to predefined criteria. If a subject was not eligible for cataract assessment procedures, the subject could still have been eligible for inclusion in the study but was exempt from the cataract assessments.||participants|||Number
735249|NCT00434161|Secondary|Change From Baseline in Posterior Subcapsular (P), Cortical (C) Cataract and Nuclear Opalescence (NO) on the Lens Opacities Classification System III (LOCS III) Scale at Months 12.|"To study the change in cataract from baseline visit to months 12, regarding the three cataract main types: nuclear, cortical and posterior subcapsular measured on the Lens Opacities Classification System III (LOCS III) Scale. To assess the effect of palifermin on the incidence of cataract development or progression at Month 6 and Month 12 based on an increase of ≥ 0.3 in the Lens Opacities Classification System (LOCS III) score for Posterior Subcapsular cataract (P), Cortical Cataract (C) and Nuclear Opalescence (NO).
The LOCS III is a standard system used for grading and comparison of cataract severity and type. The ophthalmologist uses a slit lamp for examining the lens of the eye. The classification evaluates: P,C and NO. NO is graded on a decimal scale of 0.1 to 6.9, based on a set of 6 standardized photographs. C and P are graded on a decimal scale of 0.1 to 5.9, based on a set of 5 standardized photographs each."|Months 12|All subjects in the acute phase study were also assessed for their eligibility for cataract assessment procedures according to predefined criteria. If a subject was not eligible for cataract assessment procedures, the subject could still have been eligible for inclusion in the study but was exempt from the cataract assessments.||units on a scale||Standard Deviation|Mean
735250|NCT00434161|Secondary|Change From Baseline in Posterior Subcapsular (P), Cortical (C) Cataract and Nuclear Opalescence (NO) on the Lens Opacities Classification System III (LOCS III) Scale at Months 6.|"To study the change in cataract from baseline visit to months 6, three cataract main types: nuclear, cortical and posterior subcapsular measured on the Lens Opacities Classification System III (LOCS III) Scale.
To assess the effect of palifermin on the incidence of cataract development or progression at Month 6 and Month 12 based on an increase of ≥ 0.3 in theLOCS III score for Posterior Subcapsular cataract (P), Cortical Cataract (C) and Nuclear Opalescence (NO).
The LOCS III is a standard system used for grading and comparison of cataract severity and type. The ophthalmologist uses a slit lamp for examining the lens of the eye. The classification evaluates: P,C and NO. NO is graded on a decimal scale of 0.1 to 6.9, based on a set of 6 standardized photographs. C and P are graded on a decimal scale of 0.1 to 5.9, based on a set of 5 standardized photographs each."|Months 6|All subjects in the acute phase study were also assessed for their eligibility for cataract assessment procedures according to predefined criteria. If a subject was not eligible for cataract assessment procedures, the subject could still have been eligible for inclusion in the study but was exempt from the cataract assessments.||units on a scale||Standard Deviation|Mean
735251|NCT00434161|Secondary|Incidence of an Increase Posterior Subcapsular Cataract (P), Cortical Cataract (C) and Nuclear Opalescence (NO) at Month 6 and 12|"To assess the effect of palifermin on the incidence of cataract development or progression at Month 6 and Month 12 based on an increase of ≥ 0.3 in the Lens Opacities Classification System (LOCS III) score for Posterior (P), Cortical Cataract (C) and Nuclear Opalescence (NO).
For Subcapsular cataract (P), Cortical Cataract (C) and Nuclear Opalescence (NO): at month 6 and 12 adjusted difference of rate of cataract, Palifermin - Placebo were used and the confidence interval were calculated on the adjusted difference."|at Month 6 and Month 12|281 subjects participated in the acute phase study of those 101 subjects were eligible for the cataract assessment study, 22 placebo and 79 palifermin. Month 6: 69 completed (17/22 [77.3%] in the placebo, 52/79 [65.8%] in the palifermin. Month 12: 66 completed (14/22 [63.6%] in the placebo, 52/79 [65.8%] in the palifermin group.||participants|||Number
735252|NCT00434161|Secondary|Incidence of Cataract Development or Progression (Change of ≥0.3 in Lens Opacities Classification System III (LOCS III Score)) at Month 6.|Number of participants from the primary cataract subset showing an increase from baseline of >= 0.3 in the Lens Opacities Classification System III (LOCS III score). The LOCS III is a standard system used for grading and comparison of cataract severity and type. The ophthalmologist trained in LOCS III uses a slit lamp for examining the lens of the eye. The classification evaluates four features: posterior subcapsular cataract(P),cortical cataract(C),nuclear opalescence(NO) and nuclear color(NC). NO and NC are graded on a decimal scale of 0.1 to 6.9, based on a set of 6 standardized photographs. C and P are graded on a decimal scale of 0.1 to 5.9, based on a set of 5 standardized photographs each. In the current study, cataract development or progression was defined as an increase from baseline of ≥ 0.3 on any of the three features P, C or NO (NC is of less importance and has not been analysed further in this study).|6 Months|Of the 281 subjects who participated in the acute phase of the study a total of 101 subjects study were eligible for participation in the cataract assessment procedures, 22 in the placebo group and 79 in the palifermin group. Number of patients with non-missing values at Months 6; were 17 in the placebo group and 53 in the palifermin group.||participants|||Number
735253|NCT00434161|Secondary|The Area Under the Curve (AUC) Was Calculated From the Patient-reported Outcome Mouth and Throat Soreness (MTS) Score.|"The mean daily scores were calculated using the subject daily assessment of Patient-reported mouth and throat soreness (MTS) on the 5 point scale with higher values in MTS indicating a worse self assessed MTS. A 5-grade WHO scale (0, 1, 2, 3, or 4). 0=no findings or erythema only, 1=soreness present with or without erythema, 2=ulcers present but able to take solid food, 3=ulcers present and only able to take liquids, 4=ulcers present/not able to take anything orally. The incidence of ulcerative mucositis WHO grades 2, 3, and 4. Measured the number of participants who had WHO grades 2, 3, and 4:
2=ulcers present but able to take solid food, 3=ulcers present and only able to take liquids, 4=ulcers present/not able to take anything orally. The area under the curve were calculated at the time points; Day(D)-2, up to Day 32."|at Day 32|||units on a scale * days||Standard Deviation|Mean
735254|NCT00434161|Secondary|Duration of Ulcerative Mucositis (WHO Grades 2, 3, and 4)|"The duration of ulcerative mucositis measured the number of days the participants had different WHO grades 2, 3, and 4:
2=ulcers present but able to take solid food, 3 =ulcers present and only able to take liquids, 4 =ulcers present/not able to take anything orally. Patients that did not have any ulcerative mucositis were given a value of 0 days."|at Day 32|Full analysis set that includes all randomized subjects (total 281 subjects), and was used to compare treatment effects for all efficacy endpoints. This set of subjects was analyzed according to their randomized treatment assignment.||Days||Full Range|Mean
735255|NCT00434161|Secondary|Incidence Ulcerative Mucositis (WHO Grades 2, 3, and 4)|"The incidence of ulcerative mucositis WHO grades 2, 3, and 4. Measured the number of participants who had WHO grades 2, 3, and 4:
2=ulcers present but able to take solid food, 3=ulcers present and only able to take liquids, 4=ulcers present/not able to take anything orally."|at Day 32|Full analysis set that includes all randomized subjects (total 281 subjects), and was used to compare treatment effects for all efficacy endpoints. This set of subjects was analyzed according to their randomized treatment assignment.||participants|||Number
735256|NCT00434161|Primary|Maximum Severity of Oral Mucositis (World Health Organization (WHO) Grades 0/1, 2, 3, or 4)|"For the primary efficacy endpoint maximum severity of Oral Mucositis (OM) was assessed, the number of participants who had the different severity. To assess severity of OM, a 5-grade WHO scale (0, 1, 2, 3, or 4) was used.
0 = no findings or erythema only, 1= soreness present with or without erythema, 2=ulcers present but able to take solid food, 3 =ulcers present and only able to take liquids, 4 =ulcers present/not able to take anything orally."|at Day 32|Full analysis set that includes all randomized subjects, and was used to compare treatment effects for all efficacy endpoints. This set of subjects was analyzed according to their randomized treatment assignment.||Participants|||Number
735257|NCT00434213|Secondary|Contact Sensitization to Methylphenidate|Contact sensitization to methylphenidate through skin patch testing.|7 weeks|Safety population||Participants|||Number
735258|NCT00434213|Primary|Dermal Reactions|Dermal reactions were graded on a scale ranging from 0 (no irritation) to 7 (strong reaction) for observed findings of erythema, edema, papules, and vesicles.|7 weeks|Safety population||Participants|||Number
735259|NCT00434226|Secondary|Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption|All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0|60 days following the last administration of study treatment|Treated patients||participants|||Number
735260|NCT00434226|Secondary|Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction|All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0|60 days following the last administration of study treatment|Treated patients||participants|||Number
735261|NCT00434226|Secondary|Incidence of Grade ≥ 3 Adverse Events|All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0|60 days following the last administration of study treatment|Treated patients||participants|||Number
735262|NCT00434226|Secondary|Serious Adverse Events|All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0|60 days following the last administration of study treatment|Treated patients||participants|||Number
735263|NCT00434226|Primary|Best Response|The best overall response is the best response, per RECIST criteria, recorded from randomization until disease progression/recurrence (includes both confirmed and unconfirmed responses). Although the original primary outcome was progression-free survival, there was insufficient data available to report on that outcome.|From randomization until disease progression/recurrence|Randomized patients with at least one scan available at baseline and post-baseline||participants|||Number
735264|NCT00434252|Secondary|Number of Participants With Select Adverse Events|"Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0. Select adverse events included arterial thromboembolic events (any grade), bleeding other than pulmonary or central nervous system (CNS) bleeding (Grade >= 3), CNS bleeding (any grade), febrile neutropenia (any grade), hypertension (Grade >= 3), neutropenia (Grade >= 3), pulmonary bleeding (any grade) and wound dehiscence (Grade >= 3).
*All serious adverse events are listed in the Adverse Event Reporting section."|Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination.|The Safety-evaluable population consisted of all patients who received at least one full or partial dose of any component of study treatment.||participants|||Number
735265|NCT00434252|Secondary|Twenty−Four Week Landmark Stable Disease|"As assessed by the investigator using RECIST and defined as the absence of disease progression for 24 weeks from the time of randomization.
The percentage of patients who did not experience disease progression or death at 24 weeks following randomization was estimated using Kaplan-Meier methodology. If no tumor assessments were performed after the baseline visit, the patient will be censored at the date of randomization plus 1 day."|24 weeks|Intent-to-treat (randomized) patients||percentage of participants||95% Confidence Interval|Number
735266|NCT00434252|Secondary|Six-month Landmark Survival Rate|Six-month Landmark Survival Rate was defined as the percentage of participants surviving at 6 months following randomization. Overall Survival was estimated using the Kaplan−Meier method.|6 months|Intent-to-treat (randomized) population||percentage of participants||95% Confidence Interval|Number
735311|NCT00434356|Secondary|Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction|All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0|30 days following the last administration of study treatment|Treated patients||participants|||Number
735267|NCT00434252|Secondary|Duration of Objective Response|Duration of objective response was defined as the time from the initial objective response to documented disease progression or death, whichever occurred first, assessed by the investigator using RECIST. Progressive disease was defined as at least 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started, or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Duration of response was estimated using the Kaplan-Meier method.|Up to 102 weeks|Intent-to-treat (randomized) population. Only patients with measurable disease who achieved a response (either partial or complete) were included in the analysis of duration of response||months||95% Confidence Interval|Median
735268|NCT00434252|Secondary|Percentage of Participants With an Objective Response|"Objective response was defined as a complete or partial response according to RECIST criteria as assessed by the investigator on two consecutive assessments conducted at least 4 weeks apart.
The 95% Confidence Interval (CI) was calculated using the normal approximation to the binomial distribution."|Up to 102 weeks|Randomized Patients with Measurable Disease at Baseline||percentage of participants||95% Confidence Interval|Number
735269|NCT00434252|Secondary|Number of Participants With Objective Response|Objective response was assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) criteria and was inclusive of complete and partial response determined on two consecutive investigator assessments conducted ≥ 4 weeks apart.|Up to 102 weeks|Intent-to-treat (randomized) population.||participants|||Number
735270|NCT00434252|Secondary|Overall Survival (OS)|Overall survival was defined as the time from randomization to death from any cause. Median OS was estimated using the Kaplan−Meier method. For patients without documentation of death, overall survival will be censored at the time of the last known contact.|Up to 102 weeks|Intent-to-treat (randomized) population||months||95% Confidence Interval|Median
735271|NCT00434252|Primary|Progression-free Survival|Progression-free survival (PFS) was defined as the time from randomization to documented disease progression (at least a 20% increase in the sum of the longest diameter of target lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions) or death on study (death from any cause occurring no later than 30 days after last dose of any study treatment), whichever occurred first, as determined by the investigator using the Response Evaluation Criteria in Solid Tumors (RECIST). Median PFS was estimated using the Kaplan−Meier method.|From randomization up to102 weeks. As of the clinical cut-off date (April 2009), the maximum time on treatment was 88 weeks, median time was 12.4 weeks for the Placebo arm and 16.1 weeks for the bevacizumab arm.|Intent-to-treat (randomized) population. For patients without documentation of disease progression or death on study, PFS was censored at the time of the last tumor assessment.||months||95% Confidence Interval|Median
735272|NCT00434278|Secondary|Change in Pulmonary Function as Measured by FEV1 and FVC|FEV1 (forced expiratory volume in 1 second) and FVC (forced vital capacity) were recorded at Day 0 (baseline) and Day 14. Change in FEV1 and FVC from baseline to Day 14 was reported as a percentage of values predicted for age, height, and race.|From baseline to Day 14|Randomized patients. Patients not included in this analysis did not meet ATS reproducibility criteria. Two patients in the placebo arm whose screening visit values did not meet ATS reproducibility criteria were randomized in error and completed the study.||Percentage of predicted value||Standard Deviation|Mean
735273|NCT00434278|Primary|Change in Distance Walked in the 6-minute Walk Test|Change in distance walked was defined as (distance walked in 6 minutes at baseline [Day 0]) − (distance walked in 6 minutes at Day 14) in meters.|From baseline to Day 14|Randomized patients. For placebo arm: 2 placebo patients who were randomized did not complete the study and therefore had no values to calculate change from baseline computation.||Meters||Standard Deviation|Mean
735274|NCT00434304|Secondary|Change From Baseline in Supine and Standing Pulse Rate at Weeks 16 and 52|Change from baseline was calculated as Week 16 and Week 52 values minus baseline values.|Baseline (Screening) and Weeks 16 and 52|Safety Population: Week 16 (LOCF) = 62 participants; Week 52 (OC) = 44 participants||beats per minute (bpm)||Standard Deviation|Mean
735275|NCT00434304|Secondary|Change From Baseline in Supine and Standing Systolic and Diastolic Blood Pressure at Weeks 16 and 52|Change from baseline was calculated as Week 16 and Week 52 values minus baseline values.|Baseline (Screening) and Weeks 16 and 52|Safety Population: Week 16 (LOCF) = 62 participants; Week 52 (OC) = 44 participants||millimeters of mercury (mmHg)||Standard Deviation|Mean
735276|NCT00434304|Secondary|Number of Participants With the Indicated Shift From Baseline in 12-Lead Electrocardiogram (ECG) Findings at Weeks 16 and 52|Baseline Finding/Time Period Finding. Abbreviations: N = normal; A = abnormal; CS = clinically significant; NCS = not clinically significant. Options include N/N, N/ANCS, N/ACS, ANCS/N, ANCS/ANCS, ANCS/ACS, ACS/N, ACS/ANCS, and ACS/ACS.|Baseline (Screening) and Weeks 16 and 52|Safety Population: Week 16 (LOCF) = 62 participants; Week 52 (OC) = 44 participants||participants|||Number
735277|NCT00434304|Secondary|Urinalysis Data|The number of participants with the indicated dipstick test values were measured. Dipstick test values: Neg Value, Trace, +1, +2, +3, +4. No participants had a score of +5.|Screening, Week 16, and Week 52|Safety Population: Screening Week 16 (LOCF) = 62 participants; Week 52 (OC) = 44 participants||participants|||Number
735278|NCT00434304|Secondary|Change From Baseline in Red Blood Cell Count at Weeks 16 and 52|Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.|Baseline (Screening) and Weeks 16 and 52|Safety Population: all participants who received at least one dose of study medication. Week 16 (Last observation carried forward [LOCF]) = 62 participants; Week 52 (Observed case [OC]) = 44 participants||tera per Liter (TI/L)||Standard Deviation|Mean
735279|NCT00434304|Secondary|Change From Baseline in Platelet Count and White Blood Cell Count at Weeks 16 and 52|Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.|Baseline (Screening) and Weeks 16 and 52|Safety Population: all participants who received at least one dose of study medication. Week 16 (Last observation carried forward [LOCF]) = 62 participants; Week 52 (Observed case [OC]) = 44 participants||giga per Liter (GI/L)||Standard Deviation|Mean
735280|NCT00434304|Secondary|Change From Baseline in Hematocrit at Weeks 16 and 52|Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.|Baseline (Screening) and Weeks 16 and 52|Safety Population: all participants who received at least one dose of study medication. Week 16 (Last observation carried forward [LOCF]) = 62 participants; Week 52 (Observed case [OC]) = 44 participants||proportion of 1 (SI)||Standard Deviation|Mean
735284|NCT00434304|Secondary|Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase, and Lactate Dehydrogenase at Weeks 16 and 52|Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.|Baseline (Screening) and Weeks 16 and 52|Safety Population: all participants who received at least one dose of study medication. Week 16 (Last observation carried forward [LOCF]) = 62 participants; Week 52 (Observed case [OC]) = 44 participants||international units per Liter (IU/L)||Standard Deviation|Mean
735285|NCT00434304|Secondary|Change From Baseline in Albumin, Total Protein, and Hemoglobin at Weeks 16 and 52|Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.|Baseline (Screening) and Weeks 16 and 52|Safety Population: all participants who received at least one dose of study medication. Week 16 (Last observation carried forward [LOCF]) = 62 participants; Week 52 (Observed case [OC]) = 44 participants||grams per Liter (G/L)||Standard Deviation|Mean
735286|NCT00434304|Secondary|Percentage of Participants Who Remained in the Study on the Indicated Days|The percentage of participants remaining in the study was examined using the Kaplan-Meier method, in which a premature discontinuation will be considered as an event.|Days 0-364|FAS. Participants dropped out of the study each week.||percentage of participants|||Number
735287|NCT00434304|Secondary|Number of Participants Scored as Responders on the Clinician's Global Impression (CGI) Scale|"CGI is measured on a 7-point scale. 1: Very much improved, 2: Much Improved, 3: Minimally improved, 4: No change, 5: Minimally worse, 6: Much worse, 7: Very much worse. Responders are defined as those participants scored as very much improved or much improved."|Weeks 1-52|FAS. Participants dropped out of the study each week.||participants|||Number
735288|NCT00434304|Secondary|Summary of the Modified Hoehn & Yahr Criteria Stages|Hoehn & Yahr criteria were measured on an 8-point scale. 0: No signs of disease, 1: Unilateral disease, 1.5: Unilateral plus axial involvement, 2: Bilateral disease, 2.5: Mild bilateral disease, 3: Mild to moderate bilateral disease. No subjects evaluated had a score of 4 (severe disability) or 5 (wheelchair bound or bedridden unless aided).|Screening-Week 52|FAS. Participants dropped out of the study each week.||points on a scale|||Number
735289|NCT00434304|Secondary|Percent Change From Baseline in the Japanese UPDRS Part IV|The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per each item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications.|Baseline (Week 0) and Weeks 1-52|FAS. Participants dropped out of the study each week.||percent change||Standard Deviation|Mean
735290|NCT00434304|Secondary|Change From Baseline in the Japanese UPDRS Part IV|The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per each item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications.|Baseline (Week 0) and Weeks 1-52|FAS. Participants dropped out of the study each week.||points on a scale||Standard Deviation|Mean
735291|NCT00434304|Secondary|Total Score in the Japanese UPDRS Part IV|The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per each item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications.|Baseline (Week 0) and Weeks 0-52|FAS. Participants dropped out of the study each week.||points on a scale||Standard Deviation|Mean
735292|NCT00434304|Secondary|Percent Change From Baseline in the Japanese UPDRS Part II|The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per each item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms.|Baseline (Week 0) and Weeks 1-52|FAS. Participants dropped out of the study each week.||percent change||Standard Deviation|Mean
735293|NCT00434304|Secondary|Change From Baseline in the Japanese UPDRS Part II|The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per each item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms.|Baseline (Week 0) and Weeks 1-52|FAS. Participants dropped out of the study each week.||points on a scale||Standard Deviation|Mean
735294|NCT00434304|Primary|Plasma Trough Concentrations of SKF101468 (Ropinirole) and Its Metabolites|Blood sampling in the fixed titration phase will be performed at 24 hour post dose of the last dose of 2, 4, and 8 mg (immediately before the morning dose). Blood sampling in the maintenance dose phase will be performed at 24 hour post dose of 10 mg or more for one week or longer (immediately before the morning dose), as sampling needs to be conducted at steady state.|Weeks 1-16|PK Population. Blood sampling was performed in all participants in the Fixed titration phase and Maintenance dose phase to measure trough concentration. The maintenance dose differs for individual participants.||pg/mL||Standard Deviation|Mean
735295|NCT00434304|Primary|Food Effects on Tmax of SKF101468 (Ropinirole) and Its Metabolites|The dose of SKF101468 and its metabolites was normalized to 1 mg. Blood sampling at steady state up to 24 hours post dose after receiving the maintenance dose was conducted. In order to investigate the effect of a meal on pharmacokinetics, blood was sampled twice (after a standard morning meal and at fasted state) from identical participants. Tmax: time of maximum concentration. Data are presented as the median difference between fed and fasted states for ropinirole and each metabolite.|Weeks 5-16|PK Population||hours||90% Confidence Interval|Median
735296|NCT00434304|Primary|Food Effects on AUC0-24 of SKF101468 (Ropinirole) and Its Metabolites|The dose of SKF101468 and its metabolites was normalized to 1 mg. Blood sampling at steady state up to 24 hours (hr) post dose after receiving the maintenance dose was conducted. In order to investigate the effect of a meal on pharmacokinetics, blood was sampled twice (after a standard morning meal and at fasted state) from identical participants. AUC0-24: area under the drug concentration 24 hr curve.|Weeks 5-16|PK Population||hours*pg/mL||95% Confidence Interval|Geometric Mean
735297|NCT00434304|Secondary|Total Score in the Japanese UPDRS Part II|The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per each item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms.|Weeks 0-52|FAS. Participants dropped out of the study each week.||points on a scale||Standard Deviation|Mean
735298|NCT00434304|Secondary|Percent Change From Baseline in the Japanese UPDRS Part I|The UPDRS (Unified Parkinson's Disease Rating Scale) assesses the status of PD patients objectively. The Japanese UPDRS Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per each item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms.|Baseline (Week 0) and Weeks 1-52|FAS. Participants dropped out of the study each week.||percent change||Standard Deviation|Mean
735299|NCT00434304|Secondary|Change From Baseline in the Japanese UPDRS Part I|The UPDRS (Unified Parkinson's Disease Rating Scale) assesses the status of PD patients objectively. The Japanese UPDRS Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per each item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms.|Baseline (Week 0) and Weeks 1-52|FAS. Participants dropped out of the study each week.||points on a scale||Standard Deviation|Mean
735300|NCT00434304|Secondary|Total Score in the Japanese UPDRS Part I|The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per each item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms.|Weeks 0-52|FAS. Participants dropped out of the study each week.||points on a scale||Standard Deviation|Mean
735301|NCT00434304|Secondary|Percentage of Responders of the Total Score in the Japanese UPDRS Total Score in Part III|A responder is defined as a participant with a 30% or more reduction at baseline. The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per each item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms.|Baseline (Week 0) and Weeks 1-52|FAS. Participants dropped out of the study each week.||percentage of responders|||Number
735302|NCT00434304|Secondary|Percent Change From Baseline in the Japanese UPDRS Part III|The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per each item. A maximum total score is 108 points.The higher score indicates more severe PD symptoms.|Baseline (Week 0) and Weeks 1-52|FAS. Participants dropped out of the study each week.||percent change||Standard Deviation|Mean
735303|NCT00434304|Secondary|Change From Baseline in the Japanese UPDRS Part III|The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per each item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms.|Baseline (Week 0) and Weeks 1-52|FAS. Participants dropped out of the study each week.||points on a scale||Standard Deviation|Mean
735304|NCT00434304|Secondary|Total Score in the Japanese UPDRS Part III|The Unified Parkinson's Disease Rating Scale (UPDRS) assesses the status of Parkinson's Disease (PD) patients objectively. The Japanese UPDRS Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per each item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms.|Weeks 0-52|Full Analysis Set (FAS): all participants who progressed to the treatment phase, excluding those who did not fulfill major registration criteria, those who had not received at least one dose of the investigational drug, and those whose measured data were not available after treatment initiation. Participants dropped out of the study each week.||points on a scale||Standard Deviation|Mean
735305|NCT00434304|Primary|Food Effects on Cmax and Cmin of SKF101468 (Ropinirole) and Its Metabolites|The dose of SKF101468 and its metabolites was normalized to 1 mg. Blood sampling at steady state up to 24 hours post dose after receiving the maintenance dose was conducted. In order to investigate the effect of a meal on pharmacokinetics, blood was sampled twice (after a standard morning meal and at fasted state) from identical participants. Cmax: maximum concentration, Cmin: trough plasma concentration.|Weeks 5-16|Pharmacokinetic (PK) Population: participants who underwent blood sampling for PK research, excluding those who did not fulfill inclusion criteria and those who were considered to affect the evaluation of the PK research due to drug incompliance or other protocol violation.||picograms/milliliter (pg/mL)||95% Confidence Interval|Geometric Mean
735306|NCT00434330|Other Pre-specified|Proportion of Participants Who Maintain Hemoglobin Within 9.5 to 13.0 g/dL Throughout the Trial|Hemoglobin relative to baseline: Hemoglobin at a given time point was considered to be not within the specified range (within the range of 9.5 g/dL to 13.0 g/dL) if the hemoglobin value at the time point was not within the range and the next available hemoglobin value within 14 days after the time point also was not within the specified range. These calculations were determined for all time points within a specified time period.|Weeks 2 to 29|mITT population||percentage of participants|||Number
735307|NCT00434330|Other Pre-specified|Proportion of Participants Who Maintained Hemoglobin Within 10 to 12.5 g/dL Throughout the Trial|Hemoglobin relative to baseline: Hemoglobin at a given time point was considered to be not within the specified range (within the range of 10 g/dL to 12.5 g/dL) if the hemoglobin value at the time point was not within the range and the next available hemoglobin value within 14 days after the time point also was not within the specified range. These calculations were determined for all time points within a specified time period.|Weeks 2 to 29|mITT population||percentage of participants|||Number
735308|NCT00434330|Other Pre-specified|Proportion of Participants With Hemoglobin Within 1.0 g/dL Below Baseline to 1.5 g/dL Above Baseline Throughout the Trial (Weeks 2-29)|Hemoglobin relative to baseline: Hemoglobin at a given time point was considered to be not within the specified range (within 1 g/dL below to 1.5 g/dL above baseline) if the hemoglobin value at the time point was not within the range and the next available hemoglobin value within 14 days after the time point also was not within the specified range. These calculations were determined for all time points within a specified time period.|Weeks 2 to 29|mITT population||percentage of participants|||Number
735309|NCT00434330|Primary|Mean Hemoglobin Throughout the Trial and Mean Hemoglobin Change From Baseline Throughout the Trial.|The Baseline hemoglobin was the mean of the four most recent mid- or end-of-week predialysis hemoglobin values collected prior to study start. Study start was the date of the first dose of peginesatide injection in participants who did not have a one-week transition period, or the date when Epoetin treatment was first withheld in participants who did have a one-week transition period.|Baseline and Weeks 2-29|Modified intent-to-treat (mITT) population||g/dL||Standard Deviation|Mean
735310|NCT00434356|Secondary|Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption|All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0|30 days following the last administration of study treatment|Treated patients||participants|||Number
735314|NCT00434356|Secondary|Serious Adverse Events (SAEs)|All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0. An SAE is defined as an adverse event that results in death, is life threatening, requires hospitalization, results in significant disability, results in birth defect, or is considered a significant medical event by the investigator|30 days following the last administration of study treatment|Treated patients||participants|||Number
735315|NCT00434356|Primary|Best Response|The best overall response is the best response, per the Response Evaluation Criteria In Solid Tumors (RECIST) criteria, recorded from randomization until disease progression/recurrence (includes both confirmed and unconfirmed responses). Although the original primary outcome was progression-free survival, there was insufficient data available to report on that outcome.|From randomization until disease progression/recurrence (by patient)|Randomized patients with at least one scan available at baseline and post-baseline||participants|||Number
735316|NCT00434421|Primary|Proportion of Participants Who Discontinue Study|Proportion of participants who discontinued study for any reason following initiation of treatment (any participant who receives the initial placebo dose will be considered initiated onto treatment)|Initial placebo dose to end of 2-week treatment course (maximum study dose)|Safety Population: All study participants who were initiated onto the initial placebo study||Percentage of Participants|||Number
735317|NCT00434434|Secondary|Ratio of the Allergen Forced Expiratory Volume at One Second (FEV1) Two-point Slope at the Week 16 Allergen Challenge to the Allergen FEV1 Two-point Slope at the Baseline Allergen Challenge|FEV1 is the volume exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity, measured in liters. The allergen FEV1 two-point slope is defined as the final percent change in FEV1 from pre-challenge value divided by the final value of allergen concentration used in the challenge.|From baseline to Week 16|Modified ITT population||ratio of FEV1||Full Range|Median
735318|NCT00434434|Primary|Change in Logarithmically Transformed (log2) Allergen PC15 Concentration (Allergen Concentration Required to Evoke a 15% Decrease in FEV1)|The primary analysis included two tests: a test for superiority of the lyophilized formulation of omalizumab compared with placebo in the change of allergen concentration and a test for the superiority of the aged liquid omalizumab compared with placebo. The difference for the change in the allergen concentration between the lyophilized formulation of omalizumab and placebo, and between the aged liquid omalizumab and placebo were assessed by the exact Wilcoxon-Mann-Whitney test.|From baseline to Week 16|Modified intent-to-treat (ITT) population||concentration change||Full Range|Median
735319|NCT00434590|Secondary|Chronic Rejection as Confirmed by Renal Biopsy at 12 Months||12 months||||||
735320|NCT00434590|Secondary|Biopsy Proven Acute Rejections and Clinically Confirmed Acute Rejection at 12 Months||12 months||||||
735321|NCT00434590|Secondary|Reciprocal Slope of Serum Creatinine (mg/dL) or Micromole/l at 12 Months||12 months||||||
735322|NCT00434590|Secondary|Serum Creatinine at 12 Months||12 months||||||
735323|NCT00434590|Secondary|Creatinine Clearance at 12 Months||12 months||||||
735324|NCT00434590|Primary|Renal Function, as Assessed by Glomerular Filtration Rate (GFR) at 12 Months|The 12 month change from baseline (visit 2) in the glomerular filtration rate using the abbreviated Modification of Diet in Renal Disease (MDRD) formula to calculate GFR using the participant's serum creatinine, age, gender and ethnicity.|12 months|Study was terminated without analysis (small sample size).||mL/min||Standard Deviation|Mean
735325|NCT00434642|Secondary|Percentage of Patients Who Had at Least 1 Adverse Event||From randomization through July 19, 2013 (up to 6 years, 3 months)|Safety population: All patients who received at least 1 dose of protocol treatment. Due to errors in drug administration, the safety population included 247 patients in the carboplatin and gemcitabine + bevacizumab group and 233 patients in the carboplatin and gemcitabine + placebo group.||Percentage of participants|||Number
735326|NCT00434642|Secondary|Percentage of Patients Who Had a Gastrointestinal Perforation (GIP)|A gastrointestinal perforation is a hole that develops through the entire wall of the stomach, small intestine, large bowel, or gallbladder.|From randomization through September 17, 2010 (up to 3 years, 5 months)|Safety population: All patients who received at least 1 dose of protocol treatment. Due to errors in drug administration, the safety population included 247 patients in the carboplatin and gemcitabine + bevacizumab group and 233 patients in the carboplatin and gemcitabine + placebo group.||Percentage of participants|||Number
735327|NCT00434642|Secondary|Overall Survival|Overall survival was defined as the time from randomization to death from any cause.|From randomization through July 19, 2013 (up to 6 years, 3 months)|Intent-to-treat population: All patients randomized to treatment (242 patients in each treatment group).||Months||95% Confidence Interval|Median
735328|NCT00434642|Secondary|Duration of Objective Response (OR) as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST)|Duration of OR was analyzed in the subset of patients who achieved an OR. The duration of OR was defined as the time from the initial CR or PR until documented PD or death. Lesions were assessed by computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound every 9 weeks.|From randomization through September 17, 2010 (up to 3 years, 5 months)|Subset of the intent-to-treat population: All patients randomized to treatment who achieved an objective response.||Months||95% Confidence Interval|Median
735329|NCT00434642|Secondary|Percentage of Patients With an Objective Response as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST)|An objective response was the occurrence of either a partial response (PR) or complete response (CR). PR: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. CR: The disappearance of all target and non-target lesions. Lesions were assessed by computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound every 9 weeks.|From randomization through September 17, 2010 (up to 3 years, 5 months)|Intent-to-treat population: All patients randomized to treatment (242 patients in each treatment group).||Percentage of participants|||Number
735346|NCT00434954|Secondary|7 Point Self-monitored Blood Glucose (SMBG) Profiles|7-point self-monitored blood glucose profiles at baseline and the end of the study, measured at 7 times during the day (pre-breakfast, 2 hours post-breakfast, pre-lunch, 2 hours post-lunch, pre-dinner, 2 hours post-dinner, and 3:00am).|Baseline and 26 weeks|All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS); last observation carried forward||mg/dL||Standard Deviation|Mean
735330|NCT00434642|Primary|Progression Free Survival (PFS) as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST)|PFS was defined as the time from randomization to disease progression (PD), as determined by the investigator, or death due to any cause. PD: At least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started; the appearance of 1 or more new lesions; and/or the unequivocal progression of existing non-target lesions. Lesions were assessed by computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound every 9 weeks.|From randomization through September 17, 2010 (up to 3 years, 5 months)|Intent-to-treat population: All patients randomized to treatment (242 patients in each treatment group).||Months||95% Confidence Interval|Median
735331|NCT00434759|Primary|Change From Baseline in Liebowitz Social Anxiety Scale (LSAS)|The scale measures social anxiety and avoidance on a 4-point-scale (range of scores is 0-3). Blinded raters assessed social anxiety and avoidance behaviour relating to 24 social situations. Minimum for all 24 situations is 0, maximum for all 24 situations including the assessments for anxiety and avoidance is 144). Lower scores consider better outcome.|baseline to post-treatment (on average 24 weeks)|Intention-to-Treat||units on a scale||Standard Deviation|Mean
735332|NCT00434759|Primary|Change From Baseline in Social Phobia Scale (SPS)|The scale measures social anxiety on a 5-point scale (range of score is 0-4) ; the number of items is 20; the total minimum for all 20 items is 0 and the total maximum is 80; lower values consider better outcome.|baseline to post-treatment (on average 24 weeks)|Intention-to-Treat||units on a scale||Standard Deviation|Mean
735333|NCT00434759|Secondary|Change on Baseline in Center for Epidemiologic Studies Depression Scale (CES-D)|The scale measures depressive symptoms on 20 items on a 4-point scale (range of scores is 0-3; minimum for all 20 items is 0, maximum 60). Lower scores consider better outcome.|baseline to post-treatment (on average 24 weeks)|Intention-to-Treat||units on a scale||Standard Deviation|Mean
735334|NCT00434759|Secondary|Change From Baseline in Brief Symptom Inventory (BSI)|The scale measures general psychopathology on 53 items on a 5-point scale (range of scores is 0-4). Minimum for all 53 items is 0, maximum is 212. Lower scores consider better outcome.|baseline to post-treatment (on average 24 weeks)|Intention-to-Treat||units on a scale||Standard Deviation|Mean
735335|NCT00434759|Primary|Change From Baseline in Social Interaction Anxiety Scale (SIAS)|This scale measures interaction anxiety on a 5-point scale (range of scores is 0-4); the number of items is 20; the total minimum for all 20 items is 0 and the total maximum is 80; lower values consider better outcome.|baseline to post-treatment (on average 24 weeks)|Intention-to-Treat||units on a scale||Standard Deviation|Mean
735336|NCT00434876|Secondary|Wake After Sleep Onset Time (WASO) From an In-laboratory Polysomnogram.|The amount of time spent awake after initially falling asleep and before final awakening (in minutes). None to a fewer minutes is better (than a higher number of minutes).|Baseline, and week 8|||minutes||Standard Deviation|Mean
735337|NCT00434876|Secondary|Pittsburgh Sleep Quality Index (PSQI)|"PSQI total score (range 0-21). A PSQI total score > 5 indicates insomnia, with higher scores denoting a decrease in sleep quality.
The PSQI global score assesses for the overall quality of sleep and is computed by adding the 7 component scale scores. This widely used 19-item self-rated scale evaluates the subjective quality of sleep over the last 4 weeks. The PSQI was administered at baseline, and weeks 4, and 9."|Baseline, weeks 4, and 9.|||units on a scale||Standard Deviation|Mean
735338|NCT00434876|Secondary|Insomnia Severity Index (ISI)|ISI total score; this scale assesses for global insomnia severity (range 0-24). Higher scale scores indicate higher insomnia severity.|Baseline, weeks 1, 3, 5, and 7 of treatment.|||units on a scale||Standard Deviation|Mean
735339|NCT00434876|Primary|Sleep Efficiency (From an In-laboratory Polysomnogram)|The fraction of time spent asleep to the total time in bed (%).|Baseline, and week 8 of treatment.|||percentage||Standard Deviation|Mean
735340|NCT00434954|Secondary|Patient Reported Outcomes: Quality of Life (SF-12)|SF-12 Physical and Mental Component Summary Scores at baseline (week 0) and after 26 weeks of treatment (LOCF). SF-12 Physical and Mental Component Summary Scores are normalized scores ranging from 0 (worst case) to 100 (best case), and are derived from responses to 12 questions. Scores > 50 indicate an above-average health status.|Baseline and 26 weeks|All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS); last observation carried forward||scores on SF-12 scale||Standard Deviation|Mean
735341|NCT00434954|Secondary|Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire (DTSQ)|Total DTSQ treatment satisfaction score at baseline (week 0) and after 26 weeks of treatment (LOCF). Total DTSQ treatment satisfaction score is derived as sum score of the individual components 1 and 4-8 of the DTSQ questionnaire. Each component is scored on a scale of 0 (worst case) to 6 (best case). Higher values represent higher treatment satisfaction.|Baseline and 26 weeks|All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS); last observation carried forward||scores on DTSQ scale||Standard Deviation|Mean
735342|NCT00434954|Secondary|Change in Body Mass Index (BMI)|Change in BMI from baseline after 26 weeks of treatment (i.e., BMI at week 26 minus BMI at week 0)|Baseline and 26 weeks|All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS) and had baseline and at least one post-baseline value available; last observation carried forward||kg/m^2||Standard Error|Least Squares Mean
735343|NCT00434954|Secondary|Change in Body Weight|Change in body weight from baseline after 26 weeks of treatment (i.e., body weight at week 26 minus body weight at week 0)|Baseline and 26 weeks|All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS) and had baseline and at least one post-baseline value available; last observation carried forward||kg||Standard Error|Least Squares Mean
735344|NCT00434954|Primary|Incidence of Hypoglycemia (Percentage of Participants With at Least One Hypoglycemic Episode)|Risk for first hypoglycemic episode (blood glucose <=3.9 mmol/L or severe episode) to occur up to week 26|26 weeks|All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS)||Percentage of participants|||Number
735345|NCT00434954|Secondary|Blood Lipid Levels|Total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol (calculated), and triglyceride levels at baseline (week 0) and the end of the study (week 26)|Baseline and 26 weeks|All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS); last observation carried forward||mmol/L||Standard Deviation|Mean
735347|NCT00434954|Secondary|Incidence of Nocturnal Hypoglycemia (Percentage of Subjects Who Experienced at Least One Episode of Nocturnal Hypoglycemia During the 26 Week Treatment Period)|Risk for first nocturnal (night-time) hypoglycemic episode to occur up to week 26 (percentage of subjects who experienced at least one episode of nocturnal hypoglycemia during the 26 week treatment period) [i.e., number of subjects who experienced nocturnal hypoglycemia divided by total number of subjects times 100%].|26 weeks|All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS)||Percentage of participants|||Number
735348|NCT00434954|Secondary|Incidence of Hypoglycemic Episodes [Blood Glucose <= 3.0 mmol/L or Severe] (Percentage of Subjects Who Experienced at Least One Treatment-emergent Hypoglycemic Episode During the 26-week Treatment Period)|Risk for the first hypoglycemic episode to occur up to Week 26 (percentage of subjects who experienced at least one treatment-emergent hypoglycemic episode during the 26-week treatment period)[ i.e., number of subjects experiencing at least one hypoglycemic episode divided by total number of subjects times 100%]|26 weeks|All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS)||Percentage of participants|||Number
735349|NCT00434954|Secondary|Percentage of Subjects Achieving HbA1c Target of < 7.0%|Percentage of subjects achieving HbA1c target of < 7.0% at the end of study (week 26) [i.e., number of subjects who achieved HbA1c < 7.0% divided by total number of subjects times 100%].|26 weeks|All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS); last observation carried forward||Percentage of participants|||Number
735350|NCT00434954|Secondary|Percentage of Subjects Achieving HbA1c Target of < 6.5%|Percentage of subjects achieving HbA1c target of < 6.5% at the end of study (week 26) [i.e., number of subjects who achieved HbA1c < 6.5% divided by total number of subjects times 100%].|26 weeks|All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS); last observation carried forward||Percentage of participants|||Number
735351|NCT00434954|Primary|Change in Glycosylated Hemoglobin (HbA1c)|Change in HbA1c from baseline after 26 weeks of treatment (i.e., HbA1c at week 26 minus HbA1c at week 0)|Baseline and 26 weeks|All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS) and had baseline and at least one post-baseline value available||Percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
735352|NCT00434967|Secondary|To Compare Candesartan/HCT 32/25 mg to Its Components and to Placebo With Regard to Sitting DBP Responder Rate (Decrease in Sitting DBP ≥10 mmHg From Baseline to the End of the Study or a Sitting DBP <90 mmHg at the End of the Study).||Baseline to 8 weeks||||||
735353|NCT00434967|Secondary|To Compare Candesartan/HCT 32/25 mg to Its Components and to Placebo With Regard to Sitting DBP Control Rate at the End of the Study (Patients With Controlled Sitting DBP Are Defined as Having a Sitting DBP <90 mmHg at the End of the Study).||Baseline to 8 weeks||||||
735354|NCT00434967|Secondary|To Compare Treatment With Candesartan/HCT 32/25 mg to Each of Its Components With Regard to Change From Baseline to Week 8 in Standing DBP and Standing SBP.||Baseline to 8 weeks||||||
735355|NCT00434967|Secondary|To Describe Safety and Tolerability of the Study Treatments With Regard to Adverse Events Including Those That Lead to Treatment Discontinuation as Well as With Regard to Pulse Rate, Laboratory, Electrocardiographic and Physical Examination Findings.||Baseline to 8 weeks||||||
735356|NCT00434967|Secondary|Compare Candesartan/HCT 32/25 mg to Its Components and to Placebo With Regard to Hypertension Control Rate at the End of the Study (Patients With Controlled Sitting SBP and Sitting DBP).||Baseline to 8 weeks||||||
735357|NCT00434967|Secondary|The Number of Patients With Controlled Sitting DBP and Sitting SBP in Each Treatment Group at the End of the Study|Controlled sitting SBP and sitting DBP are defined as having sitting SBP < 140 mmHg and sitting DBP < 90 mmHg at the end of the study|8 weeks|||participants|||Number
735358|NCT00434967|Primary|Change in Sitting Systolic Blood Pressure (SBP) From Baseline to the End of the Study (Baseline to 8 Weeks)|Change (reduction) in sitting SBP at the end of the study, when compared to sitting SBP at baseline.|8 weeks|||mm Hg||Standard Error|Least Squares Mean
735359|NCT00434967|Primary|Change in Sitting Diastolic Blood Pressure (DBP) From Baseline to the End of the Study (From Baseline to 8 Weeks).|Change (reduction) in sitting DBP at the end of the study, when compared to sitting DBP at baseline.|8 weeks|||mm Hg||Standard Error|Least Squares Mean
735360|NCT00434993|Secondary|Plasma Levels of IL-6 and IL-8 on Study Day 3|Biologic end-points were selected that would provide mechanistic insight into how albuterol improved lung function. Concentrations of two proinflammatory cytokines, interleukin 6 and 8 (IL-6 and IL-8), were measured. Plasma was collected and cytokine levels were measured at baseline and 3 days after randomization. IL-6 and IL-8 levels were normalized using log transformation. Wilcoxon’s test was used to compare mean log-transformed interleukin levels per day and a mixed-effects model was fit to compare the slopes.|Measured at baseline and 3 days after randomization|Not all subjects had available data for secondary analyses and therefor the numbers will be less than the 152 (active) and 130 (placebo) arms.||pg/ml||Standard Deviation|Log Mean
735361|NCT00434993|Secondary|Hospital Mortality up to Day 60 in Subjects With Baseline Shock|Difference in the main outcome hospital mortality to study day 60 was calculated for the subset of patients who were in shock at the time of randomization. Shock was defined as mean arterial pressure<60 or the need for vasopressors (except dopamine <6 ug/kg/min).|Determined 60 days after a subject entered the study|Patients with protocol defined shock (mean arterial pressure<60 or need for vasopressors except dopamine < 6ug/kg/min) at the time of study entry.||percentage of participants who died|||Number
735362|NCT00434993|Secondary|Ventilator Free Days to Day 28 in the Subset of Patients With Baseline Shock|Difference in the main outcome Ventilator Free Days to study day 28 was calculated for the subset of patients who were in shock at the time of randomization. Shock was defined as mean arterial pressure<60 or the need for vasopressors (except dopamine <6 ug/kg/min).|Determined 28 days after a subject entered the study|Patients with protocol defined shock (mean arterial pressure<60 or need for vasopressors except dopamine < 6ug/kg/min) at the time of study entry.||days||Standard Error|Mean
735482|NCT00436007|Secondary|Number of Subjects With Serious Adverse Events (SAEs).|SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.|From Month 8 to Month 19|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||subjects|||Number
735363|NCT00434993|Secondary|Hospital Mortality to Day 60 in the Subset of Participants With ARDS|Difference in the main outcome mortality to study day 60 was calculated for the subset of patients with ARDS (defined as a PaO2/FiO2 ratio of less than or equal to 200) prior to randomization. P/F ratio is an index of the effectiveness of arterial oxygenation that corresponds to the ratio of partial pressure of arterial O2 to the fraction of inspired O2.|Determined 60 days after a subject entered the study|Patients meeting the criteria for ARDS (pre-randomization PaO2/FiO2 ratio less than or equal to 200) were selected for this subset.||percentage of participants who died|||Number
735364|NCT00434993|Secondary|Ventilator Free Days to Day 28 in the Subset of Participants With ARDS|Difference in the main outcome Ventilator Free Days to study day 28 was calculated for the subset of patients with ARDS (defined as a PaO2/FiO2 ratio of less than or equal to 200). P/F ratio is an index of the effectiveness of arterial oxygenation that corresponds to the ratio of partial pressure of arterial O2 to the fraction of inspired O2. VFD to Day 28 is defined as the number of days from the end of ventilation to day 28 in patients who maintained unassisted breathing for at least two consecutive calendar days. Patients who died before day 28 were assigned a VFD count of zero. If a patient returned to assisted breathing, subsequently required assisted breathing, and once again achieved unassisted breathing, only the VFDs after beginning the final period of unassisted breathing were counted. An increase in the number of VFDs was considered a positive result.|Determined 28 days after a subject entered the study|Patients meeting the criteria for ARDS (pre-randomization PaO2/FiO2 ratio less than or equal to 200) were selected for this subset.||days||Standard Error|Mean
735365|NCT00434993|Secondary|Number of Organ Failure-free Days at Day 28 Following Randomization|Subjects were followed for development of organ failures from date of randomization to hospital discharge or study day 28, whichever was first. Organ failure was defined as present on any calendar day when the most abnormal vital signs or clinically available lab value met the definition of clinically significant organ failure according to the Brussels Organ Failure Table. Each day a patient was alive and free of a given clinically significant organ failure was scored as a failure-free day. The worst value for a calendar day was captured (lowest systolic BP, platelet count and highest creatinine and bilirubin values). Specific definitions of organ failure were: cardiovascular-systolic BP less than or equal to 90 mmHg or on a vasopressor; coagulation-platelet count less than or equal to 80 x 1000/mm3; Renal-creatinine less than or equal to 2.0 mg/dL; Hepatic-bilirubin less than or equal to 2.0 mg/dL.|Daily from baseline to study day 28|Intent to treat.||days||Standard Error|Mean
735366|NCT00434993|Secondary|Number of ICU-free Days at 28 Days After Randomization|ICU (intensive care unit)-free days was defined as the number of days a subject was out of the ICU during study hospitalization from date of randomization up to study day 28. All incidences of ICU admission and discharge during the study hospitalization were captured. Any portion of a calendar day that a subject was in the ICU was counted as an ICU day.|Determined 28 days after a subject entered the study|Intent to treat.||days||Standard Error|Mean
735367|NCT00434993|Secondary|Mortality Prior to Hospital Discharge With Unassisted Breathing to Day 90|Success for this efficacy variable was defined as being alive on study day 90 or having been discharged alive off mechanical ventilation from the study hospital (or subsequent hospital) to the subject's original place of residence. Those participants who still remained in the hospital at 90 days after randomization were considered to have survived.|Determined 90 days after a subject entered the study|Intent to treat.||percentage of participants who died|||Number
735368|NCT00434993|Secondary|Mortality Prior to Hospital Discharge With Unassisted Breathing to Day 60|Success for this efficacy variable was defined as being alive on study day 60 or having been discharged alive off mechanical ventilation from the study hospital (or subsequent hospital) to the subject's original place of residence. Those subjects alive in hospital at day 60 were considered to have survived.|Determined 60 days after a subject entered the study|Intent to treat population.||percentage of participants who died|||Number
735369|NCT00434993|Primary|Number of Ventilator Free Days (VFD)|Ventilator-free days (VFDs) is defined as the number of days from randomization to Day 28 after achieving unassisted breathing for patients who maintained unassisted breathing for at least two consecutive calendar days. If a patient achieved unassisted breathing, subsequently required additional assisted breathing, and once again achieved unassisted breathing, we counted only the VFDs after beginning the final period of unassisted breathing. Patients who died before Day 28 were assigned zero VFDs.|Determined 28 days after a subject entered the study|All the intent to treat patients were analyzed. Data was available on all subjects for the primary analysis only.||days||Standard Error|Mean
735370|NCT00435019|Secondary|Observed Insulin Antibody Values|Observed insulin antibody values for insulin detemir specific antibodies, insulin aspart specific antibodies and insulin detemir/insulin aspart cross-reacting antibodies.|at 0 and 52 weeks|Safety analysis set (SAS): All randomised subjects exposed to at least one dose of trial product, classified according to actual treatment. In some cases, antibody samples were taken earlier than required. These results were not included. A shipment of antibody samples was lost during transportation, and thus these antibody data were missing.||Percent bound of total||Standard Deviation|Mean
735371|NCT00435019|Secondary|Number of Subjects Reporting Adverse Events|"Number of subjects reporting adverse events during the trial (from week -2 to week 52).
For details, please refer to the adverse events section."|from week -2 to week 52|Safety analysis set (SAS): all randomised subjects exposed to at least one dose of trial product, classified according to actual treatment.||participants|||Number
735372|NCT00435019|Primary|Glycosylated Haemoglobin A1c (HbA1c)|Glycosylated haemoglobin A1c (HbA1c) measured after 52 weeks of treatment and analysed by central laboratory.|after 52 weeks of treatment|Full Analysis Set (FAS) is defined as all randomised subjects exposed to at least one dose of trial product with a postbaseline observation, classified according to randomised treatment.||Percent (%) glycosylated haemoglobin||Standard Error|Mean
735373|NCT00435045|Secondary|Percent Change in Non-High Density Lipoprotein Cholesterol From Baseline to Week 16 During 40 mg Atorvastatin Treatment Period|Non-high density lipoprotein cholesterol is the Total Cholesterol minus the HDL(high density lipoproteins or the sum of the LDL, VLDL and IDL. That is, Low Density Lipoproteins, Very Low Density Lipoproteins and Intermediate Density Lipoproteins.|Baseline and Week 16|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data.||percent change||Inter-Quartile Range|Median
735374|NCT00435045|Secondary|Percent Change in Non-High Density Lipoprotein Cholesterol From Baseline to Week 12 During 20 mg Atorvastatin Treatment Period|Non-high density lipoprotein cholesterol is the Total Cholesterol minus the HDL(high density lipoproteins or the sum of the LDL, VLDL and IDL. That is, Low Density Lipoproteins, Very Low Density Lipoproteins and Intermediate Density Lipoproteins.|Baseline and Week 12|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data.||percent change||Inter-Quartile Range|Median
735375|NCT00435045|Secondary|Percent Change in Total Adiponectin From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|Adiponectin is a protein hormone that modulates a number of metabolic processes, including glucose regulation and fatty acid catabolism.|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data.||percent change||Inter-Quartile Range|Median
735376|NCT00435045|Secondary|Percent Change in Remnant-like Particle Cholesterol From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|Remnant-like particle cholesterol within the plasma has been identified as a cardiovascular risk factor.|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data.||percent change||Inter-Quartile Range|Median
735377|NCT00435045|Secondary|Percent Change in Intermediate Density Lipoprotein Particle Concentration From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|Intermediate Density Lipoprotein, or IDLs, transport cholesterol and triglycerides through the body. IDLs are a type of cholesterol that are a product of VLDL degradation and result in LDL cholesterol when broken down.|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data.||percent change||Inter-Quartile Range|Median
735378|NCT00435045|Secondary|Percent Change in Very Low Density Lipoproteins Size From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|Very low density lipoproteins are plasma lipoproteins with a high lipid content, associated with atherosclerosis.|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data.||percent change||Inter-Quartile Range|Median
735379|NCT00435045|Secondary|Percent Change in Very Low Density Lipoproteins and Chylomicron Particle Concentration Total From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|Very low density lipoproteins are plasma lipoproteins with a high lipid content, associated with atherosclerosis. Chylomicrons are One of the microscopic particles of emulsified fat found in the blood and lymph and formed during the digestion of fats.|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data.||percent change||Inter-Quartile Range|Median
735380|NCT00435045|Secondary|Percent Change in High Density Lipoprotein (HDL) Particle Size From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|Partical size suggests the bigger the better. HDL is a complex of lipids and proteins in approximately equal amounts that functions as a transporter of cholesterol in the blood. High levels are associated with a decreased risk of atherosclerosis and coronary heart disease.|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data.||percent change||Inter-Quartile Range|Median
735381|NCT00435045|Secondary|Percent Change in High Density Lipoprotein (HDL) Particle Concentration Total From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|High Density Lipoprotein partical size suggests the bigger the better. HDL is a complex of lipids and proteins in approximately equal amounts that functions as a transporter of cholesterol in the blood. High levels are associated with a decreased risk of atherosclerosis and coronary heart disease.|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Only subjects with non-missing baseline and endpoint values are included.||percent change||Inter-Quartile Range|Median
735382|NCT00435045|Secondary|Percent Change in Lipoprotein-Phosphoslipase A2 From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|Lipoprotein Phosphoslipase A2 - modified form of LDL.|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data.||percent change||Inter-Quartile Range|Median
735383|NCT00435045|Secondary|Percent Change in Low Density Lipoprotein Particle Size From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|Low-density lipoproteins - A complex of lipids and proteins, with greater amounts of lipid than protein, that transports cholesterol in the blood. High levels are associated with an increased risk of atherosclerosis and coronary heart disease. Researchers have linked LDL particle size to the subsequent development of heart disease.|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data.||percent change||Inter-Quartile Range|Median
735578|NCT00436605|Primary|Progression-free Survival|Progression will be evaluated in this study using the new international criteria proposed by the RECIST Committee. A Simon’s optimum two-stage design will be used|Time from start treatment to time of progression, assessed up to 6 months|||weeks||Full Range|Mean
735384|NCT00435045|Secondary|Percent Change in Low Density Lipoprotein Particle Concentration Total From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|Low-density lipoproteins - A complex of lipids and proteins, with greater amounts of lipid than protein, that transports cholesterol in the blood. High levels are associated with an increased risk of atherosclerosis and coronary heart disease.|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data.||percent change||Inter-Quartile Range|Median
735385|NCT00435045|Secondary|Percent Change in Eicosapentaenoic Acid (EPA) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|Eicosapentaenoic acid (EPA) is one of several omega-3 fatty acids used by the body. It is found in cold water fatty fish and in fish oil supplements, along with docosahexaenoic acid (DHA). Omega-3 fatty acids are part of a healthy diet that helps lower risk of heart disease.|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data.||percent change||Inter-Quartile Range|Median
735386|NCT00435045|Secondary|Percent Change in Docosahexaenoic Acid (DHA) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|Docosahexaenoic Acid is an omega-3 essential fatty acid.|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data.||percent change||Inter-Quartile Range|Median
735387|NCT00435045|Secondary|Percent Change in Triglycerides/High Density Lipoprotein Cholesterol Ratio From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period||Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Only subjects with non-missing baseline and endpoint values are included.||percent change||Inter-Quartile Range|Median
735388|NCT00435045|Secondary|Percent Change in Total Cholesterol/High Density Lipoprotein Cholesterol Ratio From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|Total cholesterol/High density lipoprotein cholesterol|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Only subjects with non-missing baseline and endpoint values are included.||percent change||Inter-Quartile Range|Median
735389|NCT00435045|Secondary|Percent Change in Apolipoprotein C-III From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|Apolipoprotein C-III (APOC3) is a very low density lipoprotein (VLDL) protein. APOC3 inhibits lipoprotein lipase and hepatic lipase; it is thought to delay catabolism of triglyceride-rich particles.|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data.||percent change||Inter-Quartile Range|Median
735390|NCT00435045|Post-Hoc|Percent Change in Apolipoprotein-B From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|"Apolipoprotein B is the primary apolipoprotein of low density lipoproteins (LDL or bad cholesterol), which is responsible for carrying cholesterol to tissues."|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Only subjects with non-missing baseline and endpoint values are included.||percent change||Inter-Quartile Range|Median
735391|NCT00435045|Secondary|Percent Change in Apolipoprotein-A-1 From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|Apolipoprotein A1 - major protein component of high density lipoprotein (HDL) in plasma. The protein promotes cholesterol efflux from tissues to the liver for excretion.|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Only subjects with non-missing baseline and endpoint values are included.||percent change||Inter-Quartile Range|Median
735392|NCT00435045|Secondary|Percent Change in Very Low Density Lipoproteins (VLDL) Cholesterol From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|VLDL - very-low-density lipoprotein: a plasma lipoprotein with a high lipid content, associated with atherosclerosis.|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data.||percent change||Inter-Quartile Range|Median
735393|NCT00435045|Secondary|Percent Change in Triglycerides From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|Triglycerides - A naturally occurring ester of three fatty acids and glycerol that is the chief constituent of fats and oils.|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Only subjects with non-missing baseline and endpoint values are included.||percent change||Inter-Quartile Range|Median
735394|NCT00435045|Secondary|Percent Change in Low Density Lipoprotein (LDL) Cholesterol (Beta-quantification) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|LDL - A complex of lipids and proteins, with greater amounts of lipid than protein, that transports cholesterol in the blood. High levels are associated with an increased risk of atherosclerosis and coronary heart disease.|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data.||percent change||Inter-Quartile Range|Median
735497|NCT00436163|Secondary|Percentage of HBeAg Negative Participants|HBeAg seroconversion was defined as the absence of HBeAg (HBeAg negative) and the presence of anti-HBe (anti-HBe positive) for HBeAg positive participants. Percentage of HBeAg negative participants were reported.|Week 48 and Week 72|All enrolled participants who received at least 1 dose of peginterferon alfa-2a. Here, Number of participants analyzed = participants evaluable for this outcome and n= participants with available data at specified time points.||percentage of participants|||Number
735395|NCT00435045|Secondary|Percent Change in High Density Lipoprotein (HDL)Cholesterol From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|"HDL - A complex of lipids and proteins in approximately equal amounts that functions as a transporter of cholesterol in the blood. High levels are associated with a decreased risk of atherosclerosis and coronary heart disease.
High density lipoprotein cholesterol is the Total Cholesterol minus the sum of the LDL, VLDL and IDL."|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Only subjects with non-missing baseline and endpoint values are included.||percent change||Inter-Quartile Range|Median
735396|NCT00435045|Secondary|Percent Change in Total Cholesterol (TC) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|Total Cholesterol is the sum of the High Density Lipoproteins (HDL), Low Density Lipoproteins (LDL), Very Low Density Lipoproteins (VLDL), and Intermediate Density Lipoproteins (IDL).|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Only subjects with non-missing baseline and endpoint values are included.||percent change||Inter-Quartile Range|Median
735397|NCT00435045|Primary|Percent Change in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|Non-high density lipoprotein cholesterol is the Total Cholesterol minus the HDL(high density lipoproteins or the sum of the LDL, VLDL and IDL. That is, Low Density Lipoproteins, Very Low Density Lipoproteins and Intermediate Density Lipoproteins.|Baseline and Week 8|Modified Intent To Treat (MITT) Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Only subjects with non-missing baseline and endpoint values are included.||percent change||Inter-Quartile Range|Median
735398|NCT00435162|Secondary|Change From End of Period 1 (Week 6) in Mean Sitting Diastolic Blood Pressure (MSDBP) to End of Placebo-controlled Withdrawal Period (Week 8)||week 6 and week 8|Analysis: Intention to Treat Imputation Technique: Last Observation Carried Forward (LOCF)||mm Hg||Standard Deviation|Mean
735399|NCT00435162|Secondary|Change From End of Period 1 (Week 6) in Mean Sitting Systolic Blood Pressure (MSSBP) to End of Placebo-controlled Withdrawal Period (Week 8)||week 6 and week 8|Analysis: Intention to Treat Imputation Technique: Last Observation Carried Forward (LOCF)||mm Hg||Standard Deviation|Mean
735400|NCT00435162|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)to End of Period 1 (Week 6)||baseline and week 6|Analysis: Intention to Treat Imputation Technique: Last Observation Carried Forward (LOCF)||mm Hg||Standard Deviation|Mean
735401|NCT00435162|Primary|Change in Mean Sitting Systolic Blood Pressure (MSSBP) From Baseline to End of Period 1 (Week 6)||baseline and week 6|Analysis: Intention to Treat Imputation Technique: Last Observation Carried Forward (LOCF)||mm Hg||Standard Deviation|Mean
735402|NCT00435188|Secondary|2 Minute Walk|Distance walked in two minutes in meters|12 month|||meters||Standard Deviation|Mean
735403|NCT00435188|Secondary|2 Minute Walk|Distance walked in two minutes in meters|3 month|||meters||Standard Deviation|Mean
735404|NCT00435188|Secondary|2 Minute Walk|Distance walked in two minutes in meters|Baseline|||meters||Standard Deviation|Mean
735405|NCT00435188|Secondary|Sf-36 Physical Function Subscale|This is a subscale of the SF-36 Medical Outcomes Study. The Physical Function subscale assesses a self-reported ability to perform physical tasks. It is normalized for scores to range from 0 to 100 with a higher score indicating better function.|12 month|||units on a scale||Standard Deviation|Mean
735406|NCT00435188|Secondary|Sf-36 Physical Function Subscale|This is a subscale of the SF-36 Medical Outcomes Study. The Physical Function subscale assesses a self-reported ability to perform physical tasks. It is normalized for scores to range from 0 to 100 with a higher score indicating better function.|3 month|||units on a scale||Standard Deviation|Mean
735407|NCT00435188|Secondary|Sf-36 Physical Function Subscale|This is a subscale of the SF-36 Medical Outcomes Study. The Physical Function subscale assesses a self-reported ability to perform physical tasks. It is normalized for scores to range from 0 to 100 with a higher score indicating better function.|Baseline|||units on a scale||Standard Deviation|Mean
735408|NCT00435188|Secondary|Self Rated Health|Self-report of overall health, reported as the number of participants reporting health as Excellent or Very good|12 month|||participants|||Number
735409|NCT00435188|Secondary|Self Rated Health|Self-report of overall health, reported as the number of participants reporting health as Excellent or Very good|3 month|||participants|||Number
735410|NCT00435188|Secondary|Self Rated Health|Self-report of overall health, reported as the number of participants reporting health as Excellent or Very good|Baseline|||participants|||Number
735411|NCT00435188|Secondary|Physical Activity Frequency (CHAMPS Questionnaire)|Exercise frequency derived from Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire; The Champs assesses the frequency of a range of physical activities|12 month|||times per week||Standard Deviation|Mean
735412|NCT00435188|Primary|Rapid Gait Speed||12-month|||meters/second||Standard Deviation|Mean
735413|NCT00435188|Primary|Rapid Gait Speed||3-month|||meters/second||Standard Deviation|Mean
735414|NCT00435188|Primary|Rapid Gait Speed||Baseline|||meters/second||Standard Deviation|Mean
735415|NCT00435188|Primary|Usual Gait Speed||12-month|||meters/second||Standard Deviation|Mean
735416|NCT00435188|Primary|Usual Gait Speed||3 month|||meters/second||Standard Deviation|Mean
735417|NCT00435188|Secondary|Physical Activity Frequency (CHAMPS Questionnaire)|Exercise frequency derived from Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire; The Champs assesses the frequency of a range of physical activities|3 month|||times per week||Standard Deviation|Mean
735418|NCT00435188|Secondary|Physical Activity Frequency (CHAMPS Questionnaire)|Exercise frequency derived from Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire; The Champs assesses the frequency of a range of physical activities|Baseline|||times per week||Standard Deviation|Mean
735419|NCT00435188|Primary|Usual Gait Speed|Best of two trials over 8-foot walk|Baseline|||meters/second||Standard Deviation|Mean
735498|NCT00436163|Secondary|Mean Alanine Aminotransferase (ALT) Concentrations||Week 48 and Week 72|All enrolled participants who received at least 1 dose of peginterferon alfa-2a. Here, Number of participants analyzed = participants evaluable for this outcome measure.||international units per liter (IU/L)||Standard Deviation|Mean
735420|NCT00435370|Primary|Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Cognition Domains|"The following 8 scales are combined into a single index that is normalized with a mean score of 100 and a standard deviation of 10. Higher scores are considered better cognitive performance. No subscales scores are reported and a final standardized score is reported as the average of the standardized scores on each of these scales. Here is the listing of component scales that were translated into Chinese and used for this study:
Brief Assessment of Cognition in Schizophrenia (BACS): Symbol-Coding Trail Making Test: Part A Attention/Vigilance Continuous Performance Test—Identical Pairs (CPT-IP)* Wechsler Memory Scale®—3rd Ed. (WMS®-III): Spatial Span + Letter-Number Span Hopkins Verbal Learning Test—Revised™ (HVLT-R™) Brief Visuospatial Memory Test—Revised (BVMT-R™) Neuropsychological Assessment Battery® (NAB®): Mazes
Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT™):"|end of 12 wk treatment|||units on a scale||Standard Deviation|Mean
735421|NCT00435409|Secondary|Change From Baseline in EuroQol Group’s EuroQol 5-Dimensional Self-Report Questionnaire (EQ-5D)|EQ-5D: health status in 5 dimensions (mobility, self-care, pain/discomfort, anxiety/depression, usual activities). Three-level scale (1=no problem, 2=some problem, and 3=extreme problem). A single score between 1 and 3 is generated for each domain. For each subject, the outcome rating on the 5 domains could be mapped to a single index through an algorithm. The index ranges between 0 and 1, with the higher score indicating a better health state perceived by the participant.|Day 1 of each treatment cycle (up to 3 years or end of treatment)|PRO assessments were not analyzed because the study did not meet its primary endpoint.||Score on a scale||95% Confidence Interval|Mean
735422|NCT00435409|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer’s Quality of Life Questionnaire Breast Cancer Module (EORTC QLQ-BR23)|BR23: measured disease related symptoms of dry mouth, eye pain, hair loss, hot flushes, attractiveness, future health, sexual activity, arm/shoulder pain, breast pain, swollen breast, and skin problems on the breast. Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.|Day 1 of each treatment cycle (up to 3 years or end of treatment)|PRO assessments were not analyzed because the study did not meet its primary endpoint.||Score on a scale||Standard Deviation|Mean
735423|NCT00435409|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer’s Quality of Life Questionnaire (EORTC QLQ-C30)|EORTC QLQ-C30: global health/quality of life (QoL), functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much; global/QoL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms|Day 1 of each treatment cycle (up to 3 years or end of treatment)|Patient Reported Outcomes (PRO) assessments were not analyzed because the study did not meet its primary endpoint.||score on a scale||Standard Deviation|Mean
735424|NCT00435409|Secondary|Percent Chance of Participant Survival|Probability of survival 2 years and 3 years after the first dose of study treatment.|Year 1, Year 2, Year 3|ITT population||probability of survival||95% Confidence Interval|Number
735425|NCT00435409|Secondary|Overall Survival (OS)|Time from the date of randomization to the date of death due to any cause. OS (in months) calculated as (date of death minus randomization date plus 1) divided by 30.4. For patients lacking survival data beyond the date of their last follow-up, the OS time was censored on the last date they were known to be alive. Patients lacking survival data beyond randomization had their OS times censored at randomization.|Baseline until death or up to 3 years from first dose|ITT population||months||95% Confidence Interval|Median
735426|NCT00435409|Secondary|Duration of Response (DR)|Time from the first documentation of objective tumor response (CR or PR) that was subsequently confirmed to the first documentation of disease progression (PD) or to death due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. DR (in months) was calculated as [the date response ended (date of PD or death) minus first CR or PR date that was subsequently confirmed plus 1)] divided by 30.4.|Baseline until response or disease progression (up to 3 years from first dose)|ITT subgroup of participants with a confirmed objective tumor response.||months||95% Confidence Interval|Median
735427|NCT00435409|Secondary|Percentage of Participants With Objective Response (OR)|Proportion of participants with confirmed complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST); CR: disappearance of all target lesions, PR: greater than or equal to (>=) 30 percent (%) decrease in the sum of the longest dimensions (SLD) of the target lesions taking as a reference the baseline SLD. Confirmed responses = persist on repeat imaging study at least 4 weeks after initial documentation of response. Designation of best response of stable disease (SD) required the criteria to be met at least 5 weeks after randomization.|Baseline until response or disease progression (up to 3 years from first dose)|ITT population||percentage of participants||95% Confidence Interval|Number
735428|NCT00435409|Primary|Progression Free Survival (PFS)|Defined as the time from the date of randomization to the date of the first documentation of objective tumor progression or death due to any cause, whichever occurs first. If tumor progression data include more than 1 date, the first date will be used. PFS (in months) will be calculated as (first event date minus randomization date plus 1) divided by 30.4.|Baseline until disease progression (up to 3 years from first dose)|Intent to treat (ITT) population: defined as all participants who were randomized||months||95% Confidence Interval|Median
735429|NCT00435487|Secondary|Number of Subjects With Bleeding by Thrombolysis in Myocardial Infarction (TIMI) Criteria|Thrombolysis in myocardial infarction (TIMI) major bleeding: at least a 5-grams per deciliter (g/dL) decrease in hemoglobin, at least a 15 percent (%) decrease in hematocrit, or intracranial bleeding. TIMI minor bleeding: associated with gastrointestinal or genitourinary bleeding, with an absolute decrease in hemoglobin of 4 g/dL or more, or decrease in hematocrit of at least 12%.|End of hospitalization, Day 30|Evaluable population||participants|||Number
735430|NCT00435487|Secondary|Number of Subjects With Stent Thrombosis and Abrupt Closures During Hospitalization|Abrupt vessel closure and or stent thrombosis: occurrence of vessel closure (no visible antegrade flow of contrast dye occurring after balloon angioplasty) or stent thrombosis determined angiographically.|End of hospitalization, Day 30|Evaluable population||participants|||Number
736546|NCT00442689|Primary|Change in Disposition Index|Change in disposition index (DI, insulin secretion corrected for insulin secretion) as measured by frequently-sampled IV glucose tolerance test (DI at study endpoint - baseline DI)|6 months|||min^-1||Standard Deviation|Mean
735431|NCT00435487|Secondary|Number of Subjects With Death or Non-fatal Myocardial Infarction (MI), Computed Separately, at End of Hospitalization and 30 Days|Death or non-fatal myocardial infarction (MI) after receiving 48 hours of study medication (event date - first dose date) at end of hospitalization and on Day 30. Death: fatal event resulting from any cause. New MI: defined by electrocardiographic and/or biomarker criteria of myocardial necrosis. Biochemical markers: creatine phosphokinase – myocardial band (CPK-MB) levels and the qualitative troponin-T test.|End of hospitalization, Day 30|Evaluable population||participants|||Number
735432|NCT00435487|Secondary|Number of Subjects With Recurrent Angina With or Without Need for Hospitalization and or Revascularization|Recurrent angina: angina at rest lasting at least five minutes that was associated with a new ST-segment shift (elevation or depression) of more than 0.1 millivolt (mV), or with T-wave inversions, in two contiguous electrocardiographic leads; angina without electrocardiographic changes that prompted a decision to perform a revascularization procedure; or angina after hospital discharge that resulted in rehospitalization.|End of hospitalization, Day 30|Evaluable population||participants|||Number
735433|NCT00435487|Secondary|Number of Subjects With Stroke|Stroke: a sudden, focal neurologic deficit that is not reversible within 24 hours and is not the result of any readily identifiable cause (e.g., tumor or trauma).|End of hospitalization, Day 30|Evaluable population||participants|||Number
735434|NCT00435487|Primary|Number of Subjects With Death or Non-fatal Myocardial Infarction Through and Up to Day 30|Death or non-fatal myocardial infarction (MI) after receiving 48 hours of study medication (event date - first dose date) on or before day 30 from baseline. Death: fatal event resulting from any cause. New MI: electrocardiographic (ECG) and or biomarker criteria of myocardial necrosis. Biochemical markers: creatine phosphokinase – myocardial band (CPK-MB) levels and the qualitative troponin-T test.|Baseline to Day 30|Evaluable population: all subjects who took study medication for at least 48 hours from baseline and had complete information on the endpoint.||participants|||Number
735435|NCT00435539|Primary|Proportion of Subjects With Total PVD at the First Day 14 Post-injection Visit (Vitreous Detachment to the Equator) as Determined by Masked Central Reading Center (CRC) Evaluation of B-scan Imaging.||Day 14|Intention to Treat (ITT)||percentage of participants|||Number
735436|NCT00435539|Secondary|Resolution of Vitreomacular Traction (Investigator's Assessment)|Resolution of VMT was evaluated by the investigator using optical coherence tomography (OCT).Resolution of VMT was defined as a change from baseline status of Yes to post-injection status of No and was evaluated by the investigator using OCT. Subjects undergoing vitrectomy had their last observation prior to vitrectomy carried forward.|Day 28|Intention to Treat (ITT)||Percentage of participants|||Number
735437|NCT00435591|Secondary|Number of Patients With Confirmed Serum Sodium Level Exceeding 6 mEq/L Increase From Baseline or Confirmed Normal Serum Sodium Level Exceeding 135 mEq/L Over the Duration 0-24.5 Hours, 0-48.5 Hours, and 0-96.5 Hours|"Patients with confirmed serum sodium level exceeding 6 mEq/L increase from baseline or confirmed normal serum sodium level exceeding 135 mEq/L.
Baseline serum sodium value is the average of 2 serum sodium values taken at least 4 hours apart on Day-1 and within 24 hours of Hour 0 in the Treatment Period."|0-24.5 hours, 0-48.5 hours and 0-96.5 hours|"Population is Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study drug and who had both baseline and postbaseline serum sodium data.
The number of participants per arm is consistent for all categories of the data table."||Participants|||Number
735438|NCT00435591|Secondary|Number of Patients With Confirmed Serum Sodium Level Exceeding 4 mEq/L Increase From Baseline Over the Duration 0-24.5 Hours, 0-48.5 Hours, and 0-96.5 Hours|"Patients with confirmed serum sodium level exceeding 4 mEq/L increase from baseline.
Baseline serum sodium value is the average of 2 serum sodium values taken at least 4 hours apart on Day-1 and within 24 hours of Hour 0 in the Treatment Period."|0-24.5 hours, 0-48.5 hours and 0-96.5 hours|"Population is Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study drug and who had both baseline and postbaseline serum sodium data.
The number of participants per arm is consistent for all categories of the data table."||Participants|||Number
735439|NCT00435591|Secondary|Time From the First Dose of Study Drug to a Confirmed > 4 mEq/L Increase From Baseline in Serum Sodium During the 48.5 Hour Treatment Period|"The upper limits of the interquartile range were not estimable in three of the treatment arms. Only the “placebo loading dose + YM087 premix continuous infusion” arm will be reported.
Time is number of hours to reach an increase of exceeding 4 mEq/L from baseline serum sodium.
Baseline serum sodium value is the average of 2 serum sodium values taken at least 4 hours apart on Day-1 and within 24 hours of Hour 0 in the Treatment Period."|48.5 hours|"Population is Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study drug and who had both baseline and postbaseline serum sodium data.
The number of participants per arm is consistent for all categories of the data table."||Hours||Inter-Quartile Range|Median
735440|NCT00435591|Secondary|Baseline Adjusted Area Under the Concentration - Time Curve (AUC) in Serum Sodium Over the Duration of the First 24.5 Hours, the First 48.5 Hours, and the First 96.5 Hours|"AUCna t is calculated as the baseline-adjusted area under serum sodium levels for a duration of time 0 to time t.
Baseline serum sodium value is the average of 2 serum sodium values taken at least 4 hours apart on Day-1 and within 24 hours of Hour 0 in the Treatment Period."|24.5 hours, 48.5 hours and 96.5 hours|"Population is Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study drug and who had both baseline and postbaseline serum sodium data.
The number of participants per arm is consistent for all categories of the data table."||hr * mEq/L||Standard Deviation|Mean
735441|NCT00435591|Secondary|Change From Baseline in Serum Sodium at Each Time Point Over the Duration of the Treatment Period and 7-day Post Treatment Period|"Baseline serum sodium value is the average of 2 serum sodium values taken at least 4 hours apart on Day-1 and within 24 hours of Hour 0 in the Treatment Period.
Change from Baseline is calculated as Time point minus Baseline."|Baseline at 4, 6, 10, 16, 24, 30, 40, 48.5 hours and 7 days post-treatment|"Population is Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study drug and who had both baseline and postbaseline serum sodium data.
The number of participants analyzed per arm represents Full Analysis Set. The numbers of participants for each time point are noted in the category titles."||mmol/L||Standard Deviation|Mean
735533|NCT00436345|Primary|Duration of Time on Mechanical Ventilation (Modified-Intent-to-Treat Population)|Time from start of mechanical ventilation until actual extubation.|Up to 38 days (912 hours)|Modified-Intent-to-Treat (mITT) Population: all randomised participants who had taken at least one dose of study medication and who had efficacy measurements||Hours||Standard Error|Mean
735442|NCT00435591|Primary|Number and Severity of Infusion Site Reactions (ISRs) Using a Modified ISR Reporting Scale for Phlebitis and Infiltration in Patients Treated With Dose Regimen 1 and Dose Regimen 2|"Infusion Site Reaction (ISR) was any local event other than isolated pain, bleeding, or bruising at the site of infusion.
One ISRMS has been reported for each participant & represents the most severe state of ISR for that participant.
ISR scale is a health care provider assessment of ISRs using the following modified 5 point reporting scale: 0= No new reaction; 1+=Infusion site erythema, infusion site pain, infusion site warmth; 2+= Infusion site edema; 3+=Phlebitis, venous induration; 4+=Thrombophlebitis, venous thrombosis, infusion site infection, infusion site cellulitis"|48 hours|"Population is Safety Analysis Set (SAF): All randomized patients who received at least 1 dose of study drug.
The number of participants per arm is consistent for all categories of the data table."||Participants|||Number
735443|NCT00435825|Secondary|Quantitative HBV-DNA 24 Weeks Following End of Treatment|Blood was collected for HBV-DNA and was analyzed at the central laboratories using the Roche approved PCR methodology 24 weeks following the end of treatment.|24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)|Participants from the Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation who had data available for analysis. Patients were analyzed according to the treatment received. 10 patients in the per-protocol population switched treatment groups for the analysis.||IU/mL Log10||95% Confidence Interval|Mean
735444|NCT00435825|Secondary|Quantitative Serum Alanine Aminotransferase (ALT) 24 Weeks Following End of Treatment|Blood was collected 24 weeks following the end of treatment for ALT and was analyzed at a local laboratory. A normal ALT is a value within the normal range of the assay: 0- 55 units/liter (U/L).|24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)|Participants from the Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation who had data available for analysis. Patients were analyzed according to the treatment received. 10 patients in the per-protocol population switched treatment groups for the analysis.||U/L||95% Confidence Interval|Mean
735445|NCT00435825|Secondary|Percentage of Participants With Dual Endpoint Response 24 Weeks Following End of Treatment|Dual endpoint was defined as the achievement of both HBeAg seroconversion and a HBV-DNA <2,000 IU/ml (Less than 10,000 copies/mL).|24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)|Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis.||Percentage of participants||95% Confidence Interval|Number
735446|NCT00435825|Secondary|Percentage of Participants With Combined Endpoint Response 24 Weeks Following End of Treatment|Combined endpoint was defined as HBeAg seroconversion, a normal serum ALT and HBV-DNA suppression below 20,000 IU/mL.|24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)|Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis.||Percentage of participants||95% Confidence Interval|Number
735447|NCT00435825|Secondary|Percentage of Participants With Hepatitis Deoxyribonucleic Acid (HBV-DNA) Suppression < 2,000 IU/mL 24 Weeks Following End of Treatment|Blood was collected for HBV-DNA and was analyzed at the central laboratories using the Roche approved PCR methodology 24 weeks following the end of treatment. Percentage of participants with A HBV-DNA Suppression of < 2,000 IU/mL (Less than 10,000 copies/mL) is reported.|24 Weeks following end of treatment (Week 48 for 24 Week Treatment of Week 72 for 48 Week Treatment)|Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis.||Percentage of participants||95% Confidence Interval|Number
735448|NCT00435825|Secondary|Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 20,000 IU/mL 24 Weeks Following End of Treatment|Blood was collected for HBV-DNA 24 weeks following the end of treatment and was analyzed at the central laboratory using the Roche approved polymerase chain reaction (PCR) methodology. Percentage of participants with a HBV-DNA suppression of < 20,000 IU/mL (Less than 100,000 copies/mL) is reported.|24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)|Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis.||Percentage of participants||95% Confidence Interval|Number
735449|NCT00435825|Secondary|Percentage of Participants With Normal Alanine Aminotransferase (ALT)|Blood was collected 24 weeks following the end of treatment for ALT and was analyzed at a local laboratory. A normal ALT is a value within the normal range of the assay.|24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)|Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis.||Percentage of participants||95% Confidence Interval|Number
735450|NCT00435825|Secondary|Percentage of Participants With Loss of Hepatitis B Surface Antigen (HBsAg) 24 Weeks Following End of Treatment|Blood was collected for HBsAg 24 weeks following the end of treatment. Loss of HBsAg is defined as the absence of HBsAg.|24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)|Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis.||Percentage of participants||95% Confidence Interval|Number
735534|NCT00436345|Secondary|Duration of Time in Intensive Care Unit (ICU) and Potential Stay in ICU (the Time Expected for Extubation, i.e., the Time Between Intubation and Eligibility for Extubation, According to Investigator’s Decision)|Duration of Intensive Care Unit (ICU) stay and the duration of potential stay in the ICU were measured.|Up to 38 days (912 hours)|ITT Population. Only participants with available ICU data were analyzed.||Hours||Standard Deviation|Mean
735451|NCT00435825|Secondary|Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion 24 Weeks Following the End of Treatment|HBsAg seroconversion was defined as the absence of HBsAg (a negative result for HBsAg) and the presence of anti-HBs (a positive result for anti-HBs) determined at 24 weeks after the end of treatment.|24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)|Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis.||Percentage of participants||95% Confidence Interval|Number
735452|NCT00435825|Secondary|Percentage of Participants With Loss of Hepatitis Be Antigen (HBeAg) 24 Weeks Following End of Treatment|Blood was collected HBeAg 24 Weeks following the end of treatment. Loss of HBeAg is defined as the absence of HBeAg.|24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)|Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the Per protocol population switched treatment groups for the analysis.||Percentage of participants||95% Confidence Interval|Number
735453|NCT00435825|Secondary|Percentage of Participants With Hepatitis Be Antigen (HBeAg) Seroconversion at Week 72|Blood was collected for HBeAg. HBeAg seroconversion was defined as the absence of HBeAg (a negative result for HBeAg) and the presence of anti-HBe (a positive result for anti-HBs) determined at Week 72.|Week 72|Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis.||Percentage of participants||95% Confidence Interval|Number
735454|NCT00435825|Primary|Percentage of Participants With Hepatitis Be Antigen (HBeAg) Seroconversion 24 Weeks Following End of Treatment|Blood was collected for HBeAg. HBeAg seroconversion was defined as the absence of HBeAg (a negative result for HBeAg) and the presence of anti-HBe (a positive result for anti-HBe) determined at 24 weeks after the end of treatment.|24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)|Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis.||Percentage of participants||95% Confidence Interval|Number
735455|NCT00435929|Secondary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings|Abnormal ECG findings included are high and low Heart Rate (HRT), high and low PQ/PR interval (PQ/PR), high and low QRS interval (QRS), high and low QT interval (QT), high and low QTCB interval (QTcB), high and low QTcF interval (QTcF), high and low RR interval (RR), high and low T Wave, high and low U Wave, high and low ECG. The 12 Lead ECG was recorded after participants were in a semi-supine position for at least 5 minutes. Only participants with abnormal ECG findings are presented in the table below.|Up to Day 35|Safety population: All participants who received at least 1 dose of study medication (whether or not they were withdrawn prematurely) and had safety follow-up data were included in safety analysis.||participants|||Number
735456|NCT00435929|Secondary|Number Participants With Abnormal Vital Signs|Abnormal Vital signs included are high and low Pulse rate (PR), high and how Temperature (Temp), high and low Systolic Blood Pressure (SBP) and high and low Diastolic Blood Pressure (DBP). Vital signs (SBP, DBP, PR,Temp) were measured after participants were in a semi-supine position for at least 5 minutes.|Up to Day 35|Safety population: All participants who received at least 1 dose of study medication (whether or not they were withdrawn prematurely) and had safety follow-up data were included in safety analysis.||participants|||Number
735457|NCT00435929|Secondary|Number of Participants With the Indicated Grade 3 and Grade 4 Laboratory Parameters|Laboratory parameters specified in Clinical Operating Guidelines (COG) were summarized. AIDS Clinical Trial Group (ACTG) and American Heart Association (AHA) criteria were used to grade COG laboratory test values. Laboratory parameters for which an increase to Grade 3 (G3) or Grade 4 (G4) occurred are presented in the table below.|Up to Day 35|Safety population: All participants who received at least 1 dose of study medication (whether or not they were withdrawn prematurely) and had safety follow-up data were included in safety analysis.||participants|||Number
735458|NCT00435929|Secondary|Cluster of Differentiation 4 (CD4 ) Count|The pharmacodynamic profile for following 14 days of administration with SQV/RTV 1000/100 mg BID included determining the cluster of differentiation 4 (CD4) count in participants in each group.|Screening (Day -35 to -1), pre-dose on Day 8, Day 14 and at follow up (Day 28-Day 35)|PD analysis population: All participants who received at least 1 dose of the study medication and had at least 1 pharmacodynamic (PD) measure were included in the PD analysis population.||cells/cubic millimeter||Standard Deviation|Mean
735459|NCT00435929|Secondary|Volume of Distribution (Vd) of SQV and RTV|Vd is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. The pharmacokinetic profile for following 14 days of administration with SQV/RTV 1000/100 mg BID included determining the Vd of SQV and RTV The Vd was analyzed for SQV and RTV by non-compartmental methods, using WinNonlin.|Pre-dose and at 0.5 hr, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, and 12 hrs post dose on Day 14|Pharmacokinetic (PK) analysis population: All participants who adhered to the study protocol and had evaluable concentration data and PK parameters on Day 14.||Litres||Standard Deviation|Mean
735460|NCT00435929|Secondary|Plasma Clearance After Oral Administration (CL/F) of SQV and RTV|The CL/F is the oral clearance; that is clearance based on oral bioavailability. The Pharmacokinetic profile for following 14 days of administration with SQV/RTV 1000/100 mg BID included determining the plasma clearance after oral administration (CL/F)of SQV and RTV The CL/F was analyzed for SQV and RTV by non-compartmental methods, using WinNonlin.|Pre-dose and at 0.5 hr, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, and 12 hrs post dose on Day 14|Pharmacokinetic (PK) analysis population: All participants who adhered to the study protocol and had evaluable concentration data and PK parameters on Day 14.||L/hr||Standard Deviation|Mean
735535|NCT00436345|Primary|Duration of Time on Mechanical Ventilation (Intent-to-Treat Population)|Time from start of mechanical ventilation until actual extubation (the process of removing a tube from the airway).|Up to 38 days (912 hours)|Intent-to-Treat (ITT) Population: all randomised participants who had taken at least one dose of study medication||Hours (hr)||Standard Error|Mean
735461|NCT00435929|Secondary|Minimum Observed Plasma Concentration (Cmin) of SQV and RTV|Cmin is the minimum blood plasma concentration that a drug achieves. The Pharmacokinetic profile for following 14 days of administration with SQV/RTV 1000/100 mg BID included determining the minimum observed plasma concentration (C min) of SQV and RTV The Cmin was analyzed for SQV and RTV by non-compartmental methods, using WinNonlin.|Pre-dose and at 0.5 hr, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, and 12 hrs post dose on Day 14|Pharmacokinetic (PK) analysis population: All participants who adhered to the study protocol and had evaluable concentration data and PK parameters on Day 14.||ng/mL||Standard Deviation|Mean
735462|NCT00435929|Secondary|Terminal Half-life (T1/2) of SQV and RTV|Terminal half-life is the time measured for the plasma concentration to decrease by one half. The Pharmacokinetic profile for following 14 days of administration with SQV/RTV 1000/100 mg BID included determining the terminal half-life (T1/2) of SQV and RTV. The T1/2 was analyzed for SQV and RTV by non-compartmental methods, using WinNonlin.|Pre-dose and at 0.5 hr, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, and 12 hrs post-dose on Day 14|Pharmacokinetic (PK) analysis population: All participants who adhered to the study protocol and had evaluable concentration data and PK parameters on Day 14.||hour||Standard Deviation|Mean
735463|NCT00435929|Secondary|Time of Maximum Plasma Concentration (Tmax) of SQV and RTV|The Tmax is defined as actual sampling time to reach maximum observed analyte concentration. The Pharmacokinetic profile for following 14 days of administration with SQV/RTV 1000/100 mg BID included determining the time of maximum plasma concentration of SQV and RTV. The Tmax was analyzed for SQV and RTV by non-compartmental methods, using WinNonlin.|Pre-dose and at 0.5 hr, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, and 12 hrs post-dose on Day 14|Pharmacokinetic (PK) analysis population: All participants who adhered to the study protocol and had evaluable concentration data and PK parameters on Day 14.||hour||Standard Deviation|Mean
735464|NCT00435929|Primary|Maximum Observed Plasma Concentration (Cmax) of SQV and RTV|The plasma concentration (Cmax) is defined as maximum observed analyte concentration. The pharmacokinetic profile for following 14 days of administration with SQV/RTV 1000/100 mg BID included determining the maximum observed plasma concentration (C max) of SQV and Ritonavir RTV The Cmax was analyzed for SQV and RTV by non-compartmental methods, using WinNonlin.|Pre-dose and at 0.5 hr, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, and 12 hrs post-dose on Day 14|Pharmacokinetic (PK) analysis population: All participants who adhered to the study protocol and had evaluable concentration data and PK parameters on Day 14.||ng/mL||Standard Deviation|Mean
735465|NCT00435929|Primary|Area Under the Plasma Concentration-Time Curve From Time of Administration to 12 Hours After Dosing (AUC 0-12h) of Saquinavir (SQV) and Ritonavir (RTV)|Area Under the Plasma Concentration-Time Curve (AUC) is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption. The pharmacokinetic profile for following 14 days of administration with SQV/RTV 1000/100 mg BID included determining the area under the plasma concentration-time curve from 0 to 12 hours after dosing (AUC (0-12h) of SQV and RTV The AUC (0-12hours) was analyzed for SQV and RTV by non-compartmental methods, using WinNonlin.|Pre-dose and at 0.5 hr, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, and 12 hrs post-dose on Day 14|Pharmacokinetic (PK) analysis population: All participants who adhered to the study protocol and had evaluable concentration data and PK parameters on Day 14.||ng*hr/mL||Standard Deviation|Mean
735466|NCT00435942|Primary|Primary Safety Endpoint: Distribution of Major Adverse Events|The primary safety endpoint was the distribution of participants experiencing at least 1 of the major adverse events (aneurysm-related mortality, stroke, paralysis/paraplegia, myocardial infarction, procedural bleeding, respiratory failure, renal failure, and wound healing complications) within 1 year post-procedure|1 year|The number of subjects who underwent the endovascular procedure or open surgical repair||participants|||Number
735467|NCT00435942|Primary|Primary Effectiveness Endpoint: Freedom From Major Adverse Device Effects|"The primary effectiveness endpoint was freedom from major device-related adverse events [endoleak (Types I, III and IV), stent migration (> 10mm as compared to the 1 month visit), lumen occlusion, aneurysm rupture, and deployment failure/conversion to surgical repair] at 1 year post-procedure.
The proportion of participants in the Effectiveness sample who were free from major device-related AEs at 1-year post-procedure was compared against a performance goal of 0.80 using a 1-sided z-test (normal approximation to the binomial) at an alpha level of 0.025. Rejection of the null hypothesis would provide evidence that this performance goal (proportion-free greater than 0.80) was met."|1 year|All subjects who underwent the Relay implant procedure (Intention to Treat)||participants|||Number
735468|NCT00435994|Primary|Endothelial Growth Factor (VEGF)|Analysis for VEGF level by ELISA|During nasal wash|Due to limited samples and the length of time that has passed since they were obtained, we are unable to separate Bronchiolitis from RSV.||pg/dl||Standard Deviation|Mean
735469|NCT00435994|Primary|Lung Function|Lung functions were obtained under sedation using Chloral Hydrate. Forced expiratory flows are a lung volume at which the airway pressure is equal to 30 cm H2O (V30). Forced expiratory flows are measured at 75% FVC (FEF75). Measurements were repeated post bronchodilator and again post Epinephrine. A higher Z-score reflects better lung function.|Baseline, Post bronchodilator (up to 10 minutes, Post-epinephrine (up to 30 minutes)|All participants who had baseline, post bronchodilator and post epinephrine measurements were included. Participants in the Bronchiolitis arm did not have infant pulmonary functions obtained.||Z score||Standard Deviation|Mean
735470|NCT00436007|Secondary|Number of Subjects With Serious Adverse Events (SAEs).|SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.|From Month 0 to Month 19|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||subjects|||Number
735471|NCT00436007|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Unsolicited AEs were assessed following vaccination with any of the study vaccines, e. a. the Tritanrix™ HepB/Hib, Rouvax™, GSK 257049, Stamaril™ and Polio Sabin™ vaccines.|During the 30-day (Days 0-29) follow-up period after any vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||subjects|||Number
735558|NCT00436501|Secondary|Frequency and Severity of Adverse Effects of Treatment as Assessed by NCI CTCAE v3.0 (Phase II)||Up to 6 years||||||
735472|NCT00436007|Secondary|Number of Subjects With Solicited General Symptoms.|Assessed solicited general symptoms were drowsiness, fever [axillary temperature equal or above (≥) 37.5 degrees Celsius (°C)], irritability and loss of appetite following any vaccination with any of the study vaccines, e. a. the Tritanrix™ HepB/Hib, Rouvax™, GSK 257049, Stamaril™ and Polio Sabin™ vaccines.|During the 7-day (Days 0-6) follow-up period after any vaccination|The Total Vaccinated cohort included all vaccinated subjects whose symptom sheet was completed.||subjects|||Number
735473|NCT00436007|Secondary|Number of Subjects With Solicited Local Symptoms.|Assessed solicited local symptoms were pain and swelling at injection site following vaccination with each of the following study vaccines administered intramuscularly, e. a. the Tritanrix™ HepB/Hib, Rouvax™, GSK 257049 and Stamaril™ vaccines. The numbers of subjects with each of the assessed solicited local symptoms reported were tabulated for each vaccine administered, separately.|During the 7-day (Days 0-6) follow-up period after any vaccination with the Tritanrix™ HepB/Hib, Rouvax™, GSK 257049 and Stamaril™ vaccines.|The Total Vaccinated cohort included all vaccinated subjects whose symptom sheet was completed.||subjects|||Number
735474|NCT00436007|Secondary|Concentrations of Anti-circumsporozoite Protein (Anti-CS) Antibodies.|Anti-CS antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EL.U/mL). The seropositivity assay cut-off was 0.5 EL.U/mL. This outcome only covers results for the Tritanrix™ HepB/Hiberix™ Group.|At Months 0, 3, 7 and 8.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
735475|NCT00436007|Secondary|Concentrations of Anti-circumsporozoite Protein (Anti-CS) Antibodies.|Anti-CS antiibodies were measured by enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EL.U/mL). The seropositivity assay cut-off was 0.5 EL.U/mL. This outcome only covers results for the GSK 257049 2 Group.|At Months 0, 3, 7 and 8.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
735476|NCT00436007|Secondary|Concentrations of Anti-circumsporozoite Protein (Anti-CS) Antibodies.|Anti-CS antibody antibodies were measured by enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EL.U/mL). The seropositivity assay cut-off was 0.5 EL.U/mL. This outcome only covers results for the GSK 257049 1 Group.|At Months 0, 1, 3 and 7.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
735477|NCT00436007|Secondary|Titers for Anti-yellow Fever Antibodies.|"Anti-yellow fever antibody titers were expressed as geometric mean titers (GMTs). The seroprotection assay cut-off was 10. The analysis was only performed on subjects from the GSK 257049 2 and Tritanrix™ HepB/Hiberix™ groups.
The analysis was only performed on subjects from the GSK 257049 2 and Tritanrix™ HepB/Hiberix™ groups."|At Months 7 and 8.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.||titers||95% Confidence Interval|Geometric Mean
735478|NCT00436007|Secondary|Concentrations of Anti-measles Antibodies.|Anti-measles antibody concentrations were expressed as geometric mean concentrations (GMCs) in milli-international unit per milliliter (mIU/mL). The seropositivity assay cut-off was 150 mIU/mL. The analysis was only performed on subjects from the GSK 257049 2 and Tritanrix™ HepB/Hiberix™ groups.|At Months 7 and 8.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.||mIU/mL||95% Confidence Interval|Geometric Mean
735479|NCT00436007|Secondary|Concentrations of Anti-Bordetella Pertussis Toxin (Anti-BPT) Antibodies.|Anti-BPT antibodies were measured by enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EL.U/mL). The seropositivity assay cut-off was 15 EL.U/mL.|At Month 3|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
735480|NCT00436007|Secondary|Titers for Antibodies Against Poliomyelitis Types 1, 2 and 3 (Anti-Polio 1, 2 and 3 Antibodies).|Anti-Polio 1, 2 and 3 antibody titers were expressed as geometric mean titers (GMTs). The seroprotection assay cut-off was 8.|At Month 3|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.||titers||95% Confidence Interval|Geometric Mean
735481|NCT00436007|Secondary|Concentrations of Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibodies.|Anti-PRP antibody concentrations were expressed as geometric mean concentrations (GMCs) in microgram per milliliter (µg/mL). The seroprotection assay cut-off was 0.15 µg/mL.|At Month 3|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.||µg/mL||95% Confidence Interval|Geometric Mean
737577|NCT00453336|Primary|Number of Patients Achieving Complete or Partial Response 4 Months After Completion of Study Treatment|Number of subjects achieving complete response or partial response to study treatment according to RECIST Criteria version 1.0.|6 months|||participants|||Number
735483|NCT00436007|Secondary|Concentrations of Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.|Anti-D and Anti-T antibody concentrations were expressed as geometric mean concentrations (GMCs) in international unit per milliliter (IU/mL). The seroprotection assay cut-off was 0.1 IU/mL.|At Month 3|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.||IU/mL||95% Confidence Interval|Geometric Mean
735484|NCT00436007|Secondary|Concentrations of Antibodies Against Hepatitis B (Anti-HB Antibodies).|Anti-HB antibody concentrations were expressed as geometric mean concentrations (GMCs) in milli-international unit per milliliter (mIU/mL). The seroprotection assay cut-off was 10 mIU/mL. This outcome only covers results for the Tritanrix™ HepB/Hiberix™ Group.|At Months 0, 3, 7 and 8.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.||mIU/mL||95% Confidence Interval|Geometric Mean
735485|NCT00436007|Secondary|Concentrations of Antibodies Against Hepatitis B (Anti-HB Antibodies).|Anti-HB antibody concentrations were expressed as geometric mean concentrations (GMCs) in milli-international unit per milliliter (mIU/mL). The seroprotection assay cut-off was 10 mIU/mL. This outcome only covers results for the GSK 257049 2 Group.|At Months 0, 3, 7 and 8.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.||mIU/mL||95% Confidence Interval|Geometric Mean
735486|NCT00436007|Secondary|Concentrations of Antibodies Against Hepatitis B (Anti-HB Antibodies).|Anti-HB antibody concentrations were expressed as geometric mean concentrations (GMCs) in milli-international unit per milliliter (mIU/mL). The seroprotection assay cut-off was 10 mIU/mL. This outcome only covers results for the GSK 257049 1 Group.|At Months 0, 1, 3 and 7.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.||mIU/mL||95% Confidence Interval|Geometric Mean
735487|NCT00436007|Primary|Number of Subjects With Serious Adverse Events (SAEs).|SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.|From Month 0 to Month 8|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||subjects|||Number
735488|NCT00436046|Other Pre-specified|Serum Antibody Responses (Hemagglutination Inhibition (HAI) and Neutralization) to Influenza B at 28 Days After Intranasal Immunization.|Number of subjects (frequency) responding with a four-fold or greater increase (magnitude) in titer at 28 days after immunization, relative to pre-immunization levels.|28 days after immunization|||Participants|||Number
735489|NCT00436046|Secondary|Serum Antibody Responses (Hemagglutination Inhibition (HAI) and Neutralization) to Influenza A/H1N1 and A/H3N2 at 28 Days After Intranasal Immunization.|Number of subjects (frequency) responding with a four-fold or greater increase (magnitude) in titer at 28 days after immunization, relative to pre-immunization levels.|28 days after immunization|||Participants|||Number
735490|NCT00436046|Primary|Antibody Responses in Nasal Secretions to Influenza A/H1N1 and A/H3N2 at 28 Days After Intranasal Immunization|Number of subjects (frequency) responding with a four-fold or greater increase (magnitude) in titer at day 28 after immunization, relative to pre-immunization levels.|28 days after immunization.|||Participants|||Number
735491|NCT00436046|Other Pre-specified|Serum Antibody Responses (Hemagglutination Inhibition (HAI) and Neutralization) to Influenza B at 14 Days After Intranasal Immunization.|Number of subjects (frequency) responding with a four-fold or greater increase (magnitude) in titer at 14 days after immunization, relative to pre-immunization levels.|14 days after immunization|||Participants|||Number
735492|NCT00436046|Secondary|Unsolicited Adverse Events After Intranasal Immunization|Number of subjects (frequency) with spontaneous reports of Adverse Events of any severity and severe or higher severity, during the 28 days after vaccination regardless of relatedness. Events reported by more than 5.6% of subjects in any group are reported by MedDRA Preferred Term.|Non-serious AEs are collected through 28 days after vaccination. Serious AEs are collected through 180 days after vaccination.|A reporting threshold of 5.6% was selected after reviewing adverse event rates in healthy adult volunteers in similar studies sponsored by NIAID. We determined 5.6% to be the upper bound of the confidence interval to exclude reporting events that occur in 75% of healthy adults.||Participants|||Number
735493|NCT00436046|Secondary|Serum Antibody Responses (Hemagglutination Inhibition (HAI) and Neutralization) to Influenza A/H1N1 and A/H3N2 at 14 Days After Intranasal Immunization.|Number of subjects (frequency) responding with a four-fold or greater increase (magnitude) in titer at 14 days after immunization, relative to pre-immunization levels.|14 days after immunization.|||Participants|||Number
735494|NCT00436046|Secondary|Local and/or Systemic Solicited Symptoms After Intranasal Immunization.|Number of participants (frequency) reporting solicited (systematically collected on a Memory Aid) reactogenicity events of any severity and number reporting severe occurrences.|0-7 days following immunization|||Participants|||Number
735495|NCT00436046|Primary|Antibody Responses in Nasal Secretions to Influenza A/H1N1 and A/H3N2 at 14 Days After Intranasal Immunization.|Number of subjects (frequency) responding with a four-fold or greater increase (magnitude) in titer at day 14 after immunization, relative to pre-immunization levels|14 days after immunization.|||Participants|||Number
735496|NCT00436163|Secondary|Percentage of Anti-HBe Positive Participants|HBeAg seroconversion was defined as the absence of HBeAg (HBeAg negative) and the presence of anti-HBe (anti-HBe positive) for HBeAg participants. Percentage of Anti-HBe positive participants were reported.|Week 48 and Week 72|All enrolled participants who received at least 1 dose of peginterferon alfa-2a. Here, Number of participants analyzed = participants evaluable for this outcome and n= participants with available data at specified time points.||percentage of participants|||Number
735499|NCT00436163|Secondary|Percentage of Anti-HBs Positive Participants|HBsAg seroconversion was defined as the absence of HBsAg (HBsAg negative) and the presence of anti-HBs (anti-HBs positive) for HbsAg participants. Percentage of Anti-HBs positive participants were reported.|Week 48 and Week 72|All enrolled participants who received at least 1 dose of peginterferon alfa-2a. Here, Number of participants analyzed = participants evaluable for this outcome and n= participants with available data at specified time points.||percentage of participants|||Number
735500|NCT00436163|Secondary|Percentage of Hepatitis B Surface Antigen (HBsAg) Negative Participants|HBsAg seroconversion was defined as the absence of HBsAg (HBsAg negative) and the presence of anti-HBs (anti-HBs positive) for HBsAg participants. Percentage of HBsAg negative participants were reported.|Week 48 and Week 72|All enrolled participants who received at least 1 dose of peginterferon alfa-2a. Here, Number of participants analyzed = participants evaluable for this outcome measure.||percentage of participants|||Number
735501|NCT00436163|Secondary|Number of Participants With HBV-DNA < 400 Copies/mL||Week 72|All enrolled participants who received at least 1 dose of peginterferon alfa-2a. Here, Number of participants analyzed = participants evaluable for this outcome measure.||participants|||Number
735502|NCT00436163|Primary|Number of HBeAg Negative Participants With HBV-DNA < 10,000 Copies/mL|HBeAg is a soluble antigen of hepatitis B virus present in the blood during acute infection, and disappear afterward but sometimes persisting in chronic disease. HBeAg negative participants were defined as those who had HBV DNA >10,000 copies/mL at baseline. This outcome measured the number of participants with HBV DNA <10,000 copies/mL at Week 72, who were defined as HBeAg negative at baseline.|Week 72|All enrolled participants who received at least 1 dose of peginterferon alfa-2a. Here, Number of participants analyzed = participants who were HBeAg negative at baseline.||participants|||Number
735503|NCT00436163|Primary|Number of Hepatitis B Envelope Antigen (HBeAg) Positive Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Less Than (<) 1,00,000 Copies Per Milliliter (Copies/mL)|HBeAg is a soluble antigen of hepatitis B virus present in the blood during acute infection, and disappear afterward but sometimes persisting in chronic disease. HBeAg positive participants were defined as those who had HBV DNA greater than (>) 1,00,000 copies/mL at baseline. This outcome measured the number of participants with HBV-DNA levels < 1,00,000 copies/mL at Week 72, who were defined as HBeAg positive at baseline.|Week 72|All enrolled participants who received at least 1 dose of peginterferon alfa-2a. Here, Number of participants analyzed = participants who were HBeAg positive at baseline.||participants|||Number
735504|NCT00436215|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|up to 28 months|||Participants|||Count of Participants
735505|NCT00436215|Secondary|Progression-free Survival|Progression free survival is defined by the number of weeks between the first day of treatment and the date of cancer progression.|up to 28 months|||Weeks||Standard Deviation|Mean
735506|NCT00436215|Primary|Clinical Response Rate.|Clinical response rate is defined as the percentage of participants with a complete response (CR) or partial response (PR) per the Response Evaluation Criteria in Solid Tumors (RECIST). CR is disappearance of all target lesions. PR is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease (PD) is a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started lasting at least 6 months.|patients were followed for a median of 18 weeks (range 1-116 weeks)|Seven patients were not evaluable for response assessment.||percentage of participants|||Number
735507|NCT00436332|Secondary|Frequency and Severity of Toxicities||From date of registration to maximum of 3 years|Number of Subjects With Greater Than Grade 2 Toxicity||participants|||Number
735508|NCT00436332|Secondary|Response as Assessed by RECIST Criteria vs Central Computer-assisted Image-analysis System in Patients With Measurable Disease|Images for response assessed by the central computer-assisted image-analysis system were never collected.|From date of registration to maximum of 3 years|||Participants|||Count of Participants
735509|NCT00436332|Secondary|Progression-free Survival||From date of registration to maximum of 3 years|||months||95% Confidence Interval|Median
735510|NCT00436332|Primary|Overall Survival||From date of registration to maximum of 3 years|||months||95% Confidence Interval|Median
735511|NCT00436345|Secondary|Pain Intensity From Day 8 to Day 10|“Pain Intensity” was assessed by the following 6-point Pain Intensity Scale: 1, no pain; 2, mild pain; 3, moderate pain; 4, severe pain; 5 very severe pain; 6, worst possible pain.|Days 8, 9, and 10|mITT Population. Participants remained in the study until they could be extubated; thus, the number of participants analyzed may vary by day.||points on a scale||Standard Deviation|Mean
735512|NCT00436345|Secondary|Pain Intensity (PI)|“Pain Intensity” was assessed by the following 6-point Pain Intensity Scale: 1, no pain; 2, mild pain; 3, moderate pain; 4, severe pain; 5 very severe pain; 6, worst possible pain.|Up to 38 days|ITT Population, according to the participants' status. Participants remained in the study until they could be extubated; thus, the number of participants analyzed may vary by day.||Points on a scale||Standard Deviation|Mean
735513|NCT00436345|Secondary|Bispectral Index (BIS) for Extubation Period and Post-Extubation Period|The BIS monitor provides a single dimensionless number, the BIS value, which ranges from 0 to 100. A BIS value of 0 equals electroencephalogram silence, near 100 is the expected value in a fully awake adult, and between 40 and 60 indicates a level for general anaesthesia.|up to 38 days|mITT Population. The BIS value was recorded only for 2 participants, in the extubation and post-extubation periods.||points on a scale||Standard Deviation|Mean
735514|NCT00436345|Secondary|Bispectral Index (BIS) for Day 5|The BIS monitor provides a single dimensionless number, the BIS value, which ranges from 0 to 100. A BIS value of 0 equals electroencephalogram silence, near 100 is the expected value in a fully awake adult, and between 40 and 60 indicates a level for general anaesthesia.|Day 5|mITT Population. At Day 5, only one participant remained in the study; the others were already extubated.||points on a scale||Standard Deviation|Mean
735616|NCT00438451|Secondary|Results of Cognitive Testing (EpiTrack© by UCB) - Categories at V6|"Evaluation of current testing at V6:
≥29 score points: Inconspicuous; 26 to 28 score points: Borderline;
≤25 score points: Impaired"|58 weeks|Patients of ITT population with data at V6||participants|||Number
735515|NCT00436345|Secondary|Bispectral Index (BIS)|The BIS monitor provides a single dimensionless number, the BIS value, which ranges from 0 to 100. A BIS value of 0 equals electroencephalogram silence, near 100 is the expected value in a fully awake adult, and between 40 and 60 indicates a level for general anaesthesia.|Screening through End of Study, up to 38 days|mITT Population. Due to the nonmandatory nature of BIS measure in the clinical practice, some participants did not have all the measures for all days in which they were in the study.||Points on a scale||Standard Deviation|Mean
735516|NCT00436345|Secondary|Number of Participants Analyzed for BIS (Bispectral Index Scale)|Participants in the study for which BIS were evaluated. The BIS monitor provides a single dimensionless number, the BIS value, which ranges from 0 to 100. A BIS value of 0 equals electroencephalogram silence, near 100 is the expected value in a fully awake adult, and between 40 and 60 indicates a level for general anaesthesia.|Up to 38 days|mITT Population||participants|||Number
735517|NCT00436345|Secondary|Sedation-Agitation From Day 8 to Day 10|“Sedation - Agitation” was assessed, using the “Riker Sedation-Agitation Scale” (SAS), by the following 7-point scale: 7, dangerous agitation; 6, very agitated; 5, agitated; 4, calm, cooperative; 3, sedated; 2, very sedated; 1, unarousable.|Days 8, 9, and 10|mITT Population according to the participants’ status||points on a scale||Standard Deviation|Mean
735518|NCT00436345|Secondary|Sedation-Agitation for Day 7|“Sedation - Agitation” was assessed, using the “Riker Sedation-Agitation Scale” (SAS), by the following 7-point scale: 7, dangerous agitation; 6, very agitated; 5, agitated; 4, calm, cooperative; 3, sedated; 2, very sedated; 1, unarousable.|Day 7|mITT Population according to the participants’ status||points on a scale||Standard Deviation|Mean
735519|NCT00436345|Secondary|Sedation-Agitation From Screening Through the End of Study|"Sedation - Agitation” was assessed, using the “Riker Sedation-Agitation Scale” (SAS), by the following 7-point scale: 7, dangerous agitation; 6, very agitated; 5, agitated; 4, calm, cooperative; 3, sedated; 2, very sedated; 1, unarousable."|Up to 38 days|mITT Population, according to the participants’ status||Points on a scale||Standard Deviation|Mean
735520|NCT00436345|Secondary|Number of Participants Analyzed for Sedation – Agitation Scale (SAS) and Pain Intensity (PI) Scale|Data from participants in the study for which the Sedation–Agitation Scale (SAS) and Pain Intensity (PI) were recorded were analyzed. “Sedation - Agitation” was assessed, using the “Riker Sedation-Agitation Scale” (SAS), by the following 7-point scale: 7, dangerous agitation; 6, very agitated; 5, agitated; 4, calm, cooperative; 3, sedated; 2, very sedated; 1, unarousable. “Pain Intensity” was assessed by the following 6-point Pain Intensity Scale: 1, no pain; 2, mild pain; 3, moderate pain; 4, severe pain; 5 very severe pain; 6, worst possible pain.|Up to 38 Days|mITT Population||participants|||Number
735521|NCT00436345|Secondary|Total Dose of Fentanil Administered - Bolus|Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.|Up to 10 days|ITT Population. Only participants dosed with Fentanil were analyzed.||ug/kg||Standard Deviation|Mean
735522|NCT00436345|Secondary|Total Dose of Propofol Administered - Bolus|Data from this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.|Up to 10 days|ITT Population. Only participants dosed with Propofol were analyzed.||mg/kg||Standard Deviation|Mean
735523|NCT00436345|Secondary|Dose of Morphine Administered – Continuous Infusion|Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.|up to 10 days|ITT Population. Only participants dosed with Morphine were analyzed.||mg/kg/h||Standard Deviation|Mean
735524|NCT00436345|Secondary|Dose of Propofol Administered – Continuous Infusion|Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.|Up to 10 days|ITT Population. Only participants dosed with Propofol were analyzed.||mg/kg/h (milligrams per kilogram per hr)||Standard Deviation|Mean
735525|NCT00436345|Secondary|Doses of Sufentanil and Fentanil Administered – Continuous Infusion|Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.|up to 10 days|ITT Population. Only participants dosed with Remifentanil were analyzed.||ug/kg/h||Standard Deviation|Mean
735526|NCT00436345|Secondary|Dose of Remifentanil Administered – Continuous Infusion|Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.|Up to 10 days|ITT Population. Only participants dosed with Remifentanil were analyzed.||ug/kg/h (micrograms per kilogram per hr)||Standard Deviation|Mean
735527|NCT00436345|Secondary|Duration of Sufentanil, Fentanil, and Morphine Infusion (ITT Population)|Data for this measure come from the infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.|up to 10 days (240 hours)|ITT Population. Only participants infused with Sufentanil, Fentanil, and Morphine were analyzed.||hours||Standard Deviation|Mean
735528|NCT00436345|Secondary|Duration of Propofol Infusion (ITT Population)|Data for this measure come from the infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.|up to 10 days (240 hours)|ITT Population. Only participants infused with Propofol were analyzed.||hours||Standard Deviation|Mean
735529|NCT00436345|Secondary|Duration of Remifentanil Infusion (ITT Population)|Data for this measure come from the infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.|Up to 10 days (240 hours)|ITT Population. Only participants infused with Remifentanil were analyzed.||Hours||Standard Deviation|Mean
735530|NCT00436345|Secondary|Duration of Weaning|Duration of weaning (the time from the intubation until the recovery of natural respiratory ability) was measured.|up to 38 days (912 hours)|ITT Population. Only participants for which data are available were analyzed.||hours||Standard Deviation|Mean
735531|NCT00436345|Secondary|Duration of Extubation|Duration of extubation was measured.|up to 38 days (912 hours)|ITT Population. Only participants with available extubation data were analyzed.||hours||Standard Deviation|Mean
735532|NCT00436345|Primary|Duration of Time on Mechanical Ventilation (Per-Protocol Population)|Time from start of mechanical ventilation until actual extubation|Up to 38 days (912 hours)|Per-Protocol (PP) Population: all participants from the MITT population without any major protocol violation||Hours||Standard Error|Mean
735536|NCT00426764|Secondary|Change in Eastern Cooperative Oncology Group (ECOG) Performance Status|"The ECOG scale is as follows:
Grade 0: Fully active, able to perform all pre-disease activities without restriction; Grade 1: Restricted in physically strenuous activity, ambulatory, able to carry out light work; Grade 2: Ambulatory and capable of all self-care but unable to work. Up and about more than 50% of waking hours; Grade 3: Capable of only limited self-care, confined to bed or chair > 50% of waking hours; Grade 4: Completely disabled. Cannot carry on any self-care. Confined to bed or chair.
Data reported is the shift from Baseline ECOG score to best on-study assessment score."|From Baseline to 31 March 2010 (up to 33.4 months).|Safety population.||participants|||Number
735537|NCT00426764|Secondary|Time to Disease Progression|Time to progression (≥50% increase from the nadir in the individual sum of the products of the diameters of any index lesion; the reappearance of pathology, enlargement of liver/spleen, or unequivocal progression of non-measurable disease or appearance of any new lesions) was defined as the duration from the date of the first study drug dose to the date of relapse or progression as reported by the independent review committee and was determined using Kaplan-Meier product-limit estimates.|Response was assessed after every 2 cycles of treatment and at completion of therapy, up until 31 October 2010 (maximum duration on study was 1086 days).|Histopathologically-Confirmed Population. Censoring for patients who did not have a date of progression was conducted based on last assessment reported for the patient.||Days||95% Confidence Interval|Median
735538|NCT00426764|Secondary|Duration of Complete Disease Response|Duration of response was defined as the number of days from the date of the first disease response (Complete or Unconfirmed Complete) until the date of progression and was determined using Kaplan-Meier product-limit estimates. Progression was defined as: a ≥50% increase from the nadir in the individual sum of the products of the diameters of any index lesion; the reappearance of pathology, enlargement of liver/spleen, or unequivocal progression of non-measurable disease or appearance of any new lesions.|Response was assessed after every 2 cycles of treatment and at completion of therapy, up until 31 October 2010 (maximum duration on study was 1086 days).|Histopathologically-Confirmed Population with a complete response. Censoring for patients who did not have a date of progression was conducted based on last assessment reported for the patient.||days||95% Confidence Interval|Median
735539|NCT00426764|Secondary|Duration of Objective Disease Response|Duration of response was defined as the number of days from the date of the first disease response (Complete, Unconfirmed Complete or Partial Response) until the date of progression and was determined using Kaplan-Meier product-limit estimates. Progression was defined as: a ≥50% increase from the nadir in the individual sum of the products of the diameters of any index lesion; the reappearance of pathology, enlargement of liver/spleen, or unequivocal progression of non-measurable disease or appearance of any new lesions.|Response was assessed after every 2 cycles of treatment and at completion of therapy, up until 31 October 2010 (maximum duration on study was 1086 days).|Histopathologically-Confirmed Population with an objective response. Censoring for patients who did not have a date of progression was conducted based on last assessment reported for the patient.||days||95% Confidence Interval|Median
735540|NCT00426764|Secondary|Percentage of Participants With Objective Disease Response|Objective disease response was defined as patients with a Complete Response, Unconfirmed Complete Response or a Partial Response according to the IWC 1999 assessed by an independent review committee: CR, Cru defined above, PR defined as ≥50% decrease in size of 6 largest dominant nodes and/or nodal masses & extranodal index lesions and no increase of non-index lesions, liver, or spleen; no new sites of disease evident; skin lesions decreased by ≥50%.|Response was assessed after every 2 cycles of treatment and at completion of therapy, up until 31 October 2010 (maximum duration on study was 1086 days).|Histologically Confirmed Population. Patients who discontinued prior to any response evaluation or who had no post-baseline assessment of response were classified as non-responders.||percentage of participants||95% Confidence Interval|Number
735541|NCT00426764|Primary|Percentage of Participants With a Complete Response According to the International Workshop Response Criteria (IWC) for Non-Hodgkin's Lymphomas (NHL) Assessed by an Independent Review Committee|Complete Response (CR): >75% decrease in size aggregate of nodal index lesions (large and small), complete disappearance of extranodal and non-index lesions; total disappearance of clinical disease including skin involvement; disease-related signs and symptoms, normalization of biochemical abnormalities and reduction in size of spleen or liver so no longer palpable. Unconfirmed CR: all above criteria except all nodal index lesions must have regressed >75% in the sum of the product diameters (SPD) from baseline. Individual nodes previously confluent must have regressed by >75% in their SPD.|Response was assessed after every 2 cycles of treatment and at completion of therapy, up until 31 October 2010 (maximum duration on study was 1086 days).|Histologically Confirmed Population, comprised all enrolled patients who received at least 1 dose of study treatment and who had histopathologically confirmed peripheral T-cell lymphoma(s). Patients who discontinued prior to any response evaluation or who had no post-baseline assessment of response were classified as non-responders.||percentage of participants||95% Confidence Interval|Number
735542|NCT00426842|Primary|Systolic Blood Pressure|brachial artery systolic blood pressure (mmHg)|The difference between the average supine systolic blood pressure and the average systolic blood pressure at 45 degree head-up tilt position.|||mmHg||Standard Deviation|Mean
735543|NCT00426855|Primary|Optimal Bendamustine Dosage for Further Studies||Three weeks after treatment termination|||mg/m^2|||Number
735544|NCT00427011|Secondary|Mean Change From Baseline by Visit in UPDRS Part III (Motor) Score in ON State (Hours) During Open- Label Extension Study|The UPDRS is a standardized assessment of the symptoms and signs of Parkinson’s Disease. Part III assesses motor activity, based on 14 items, such as gait, facial expression, and rigidity. Participants receive a score of 0-4 points per item, with a higher score indicating more severe symptoms. Range of possible total scores, 0 to 56. ON state is when medication is providing benefits with regard to stiffness, slowness, and tremor.|Baseline, Week 12, Week 20, Week 32, Week 44, Week 56|Safety population.||scores on a scale||Standard Deviation|Mean
735559|NCT00436501|Secondary|Overall Median Duration of Response (Phase II)|Duration of the response from time response is achieved until disease progression is detected. Response assessed following treatment (every 3 weeks) for disease progression. Study duration January 2007 to May 2013, approximately six and half years.|Response assessed following treatment (every 3 weeks), up to 6 years. Study duration January 2007 to May 2013.|Number analyzed represents those Phase II participants with response as documented in Outcome Measure 2.||months||Full Range|Median
735545|NCT00427011|Secondary|Mean Change From Baseline by Visit in UPDRS Part II (ADL) in OFF State (Hours) During Open-label Extension Study|Unified Parkinson's Disease (PD) Rating Scale (UPDRS) is a standardized assessment of the symptoms and signs of PD. Part II assesses Activities of Daily Living (ADL) based on 13 items, such as speech, hygiene, and falling. Participants receive a score of 0-4 points per item, with a higher score indicating more severe symptoms. Range of possible total scores, 0 to 52. ON state is when medication is providing benefits to mobility, slowness, and stiffness. OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor.|Baseline, Week 12, Week 20, Week 32, Week 44, Week 56|Safety population.||scores on a scale||Standard Deviation|Mean
735546|NCT00427011|Secondary|Mean Change From Baseline by Visit in Absolute ON Time (Without Dyskinesias or With Nontroublesome Dyskinesias) (Hours) During Open-label Extension Study|ON state is when medication is providing benefits with regard to stiffness, slowness, and tremor. This outcome measure was based on data collected through use of a patient diary.|Baseline, Week 12, Week 20, Week 32, Week 44, Week 56|Safety population.||hours||Standard Deviation|Mean
735547|NCT00427011|Primary|Mean Change From Baseline by Visit in Absolute OFF Time (Hours) During Open-label Extension Study|OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor. This outcome measure was based on data collected through use of a patient diary.|Baseline, Week 12, Week 20, Week 32, Week 44, Week 56|Safety population.||hours||Standard Deviation|Mean
735548|NCT00427037|Primary|25-hydroxyvitamin D|25-hydroxyvitamin D measured in serum by ELISA|3 months|||ng/mL||95% Confidence Interval|Mean
735549|NCT00427037|Secondary|Bone Turnover Marker-CTX|Blood levels of C-telopeptide|12 weeks|||pg/mL||95% Confidence Interval|Geometric Mean
735550|NCT00436436|Secondary|Overall Survival|Defined as the interval between the day of first administration of treatment and the date of death.|up to 2 years|No analysis was performed. The study was closed to accrual after the company chose to stop the development of the drug.|||||
735551|NCT00436436|Secondary|Progression-free Survival|Defined as the interval between the day of first administration of treatment and the first documentation of progressive disease or date of death. Progression is a 25% increase in the sum of products of all measurable lesions (or two largest lesions if too numerous) over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer|up to 2 years|No analysis was performed. The study was closed to accrual after the company chose to stop the development of the drug.|||||
735552|NCT00436436|Secondary|Best Overall Response|Defined as the best tumor response recorded from the start of treatment until disease progression or withdrawal from the study. Complete response is complete disappearance of all measurable and evaluable disease. No new lesions. No evidence of non-evaluable disease. Partial response is greater than or equal to a 50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable lesions. Stable/No disease does not qualify for CR, PR, or progression. Progression is a 25% increase in the sum of products of all measurable lesions (or two largest lesions if too numerous) over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer|up to 2 years|No analysis was performed. The study was closed to accrual after the company chose to stop the development of the drug.|||||
735553|NCT00436436|Secondary|Toxicity as Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v 3)|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module. Adverse events were assessed by the Common Terminology Criteria in Adverse Events (CTCAE)v3.|18 months and 4 days|||Participants|||Count of Participants
735554|NCT00436436|Secondary|Objective Tumor Response Rate in Patients With Methylguanine Methyltransferase (MGMT)-Negative Tumors as Assessed by Immunohistochemistry (IHC)|The date of response will be the date the response is first radiographically documented following initiation of therapy (typically, the date of the actual imaging modality). Complete response is complete disappearance of all measurable and evaluable disease. No new lesions. No evidence of non-evaluable disease. Partial response is greater than or equal to a 50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable lesions. Stable/No disease does not qualify for CR, PR, or progression. Progression is a 25% increase in the sum of products of all measurable lesions (or two largest lesions if too numerous) over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).|2-4 weeks|Twelve patients were enrolled. The principal investigator wished to analyze the data but felt that there was insufficient data to report on and therefore closed the protocol when he left the National Cancer Institute (NCI).|||||
735555|NCT00436436|Primary|Confirmed Best Objective Tumor Response Rate (Complete or Partial Response) in Patients With Methylguanine Methyltransferase (MGMT)-Positive Tumors as Assessed by Immunohistochemistry (IHC)|The date of response will be the date the response is first radiographically documented following initiation of therapy (typically, the date of the actual imaging modality). Complete response is complete disappearance of all measurable and evaluable disease. No new lesions. No evidence of non-evaluable disease. Partial response is greater than or equal to a 50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable lesions.|2-4 weeks|No analysis was performed. The study was closed to accrual after the company chose to stop the development of the drug.|||||
735556|NCT00436501|Primary|Median Progression-Free Survival (PFS) (Phase II)|Progression-Free Survival was calculated from study entry until documented disease, death or date of last contact.|Time from start of treatment to time of progression, assessed up to 6 years.|||months||95% Confidence Interval|Median
735557|NCT00436501|Secondary|Proportion of Patients With PFS (Phase II)|Progression-free survival (PFS) defined as number of participants out of total in arm that had no disease progression as measured at 6 months. Standard RECIST criteria used to evaluate response and progression. All documented responses required confirmation by imaging, examination, or both, no sooner than 4 weeks after initial documentation of response. In the absence of new symptoms, response assessment was consistently done after two additional cycles of therapy.|6 months||||||
735560|NCT00436501|Primary|Overall Objective Response Rate According to RECIST (Phase II)|The percentage of participants in the Phase II arm with an objective response defined as a measurable response according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. Standard RECIST criteria were followed to evaluate response and progression. All documented responses were required to undergo confirmation by imaging, examination, or both, no sooner than 4 weeks after the initial documentation of response. In the absence of new symptoms, this response assessment was consistently done after two additional cycles of therapy.|Up to 6 months|||percentage of participants|||Number
735561|NCT00436501|Primary|Median Overall Survival (OS) (Phase II)|Overall survival was defined from the date of study entry until death or date of last contact. Median survival time points calculated in the method of Kaplan-Meier. Standard RECIST criteria followed to evaluate response and progression, and all documented responses required confirmation by imaging, examination, or both, no sooner than 4 weeks after the initial documentation of response. In the absence of new symptoms, response assessment consistently done after two additional cycles of therapy.|Time from start of treatment to time of progression, assessed up to 6 years.|||months||Full Range|Median
735562|NCT00436501|Primary|Number of Participants With Clinical Response (Partial Response or Complete Response) According to the Response Evaluation Criteria in Solid Tumors (RECIST)|Frequency of clinical response (partial response or complete response) according to the Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): Disappearance all target lesions; Partial Response (PR): >/= 30% decrease in sum of longest diameter (LD) of target lesions, reference baseline sum LD; Progressive Disease (PD): >/= 20% increase in sum of LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of 1+ new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum LD since treatment started.|Up to 6 months|||participants|||Number
735563|NCT00436501|Primary|Maximum Tolerated Dose of VEGF Trap (Phase I)|Escalating dose levels of VEGF Trap were administered intravenously over three dose levels (2, 4, or 6 mg/kg; one dose every 21 days) to identify the maximum tolerated dose (MTD). The MTD is defined as the highest dose level below which 2 or more patients encounter a dose limiting toxicity (DLT), graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. MTD established on absence of observed DLT(s) in either cycle 0 (single agent) or cycle 1 (combination therapy) of any given dose level.|21 day cycle, up to 3 cycles|||mg/kg|||Number
735564|NCT00436553|Primary|Percent of Patients With a Treatment-free Interval of at Least 3 Months Following the Month 2 Visit|The number of patients with a ranibizumab treatment-free interval, ie, no active ranibizumab treatments for at least 3 months duration (at least 2 consecutive monthly visits), anytime following the Month 2 ranibizumab treatment. Only active ranibizumab treatments were considered.|Month 2 up to Month 11|Full analysis set (FAS) - Only the combination groups were analyzed. The percent of subjects with a ranibizumab treatment-free interval of at least 3 months duration following the Month 2 ranibizumab treatment was calculated using the subjects still in the study at Month 5.||Percent of participants|||Number
735565|NCT00436553|Secondary|Change From Baseline in Central Retinal Thickness at Month 12|Optical coherence tomography was performed in the study eyes and the evaluations of the images were performed by the central reading center.|Baseline and Month 12|Full analysis set (FAS), observed data.||micrometer||Standard Deviation|Mean
735566|NCT00436553|Secondary|Percentage of Patients With Fluorescein Leakage in the Study Eye at Month 12|The percentage of patients with leakage of the study eye was assessed at the Central Reading Center (CRC) using Fluorescein angiography (FA).|Month 12|Full analysis set (FAS), observed data.||Percentage of participants|||Number
735567|NCT00436553|Secondary|Change From Baseline in Total Area of Leakage of the Study Eye at Month 12|Total area of leakage of the study eye was assessed at the Central Reading Center (CRC) using Fluorescein angiography (FA).|Baseline and Month 12|Full analysis set (FAS), observed data.||mm^2||Standard Deviation|Mean
735568|NCT00436553|Primary|Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) of the Study Eye at Month 12|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increase in the VA score indicates improvement in visual acuity.|Baseline and Month 12|The Full analysis set (FAS) consisting of all randomized patients that received at least one application of study drug and had at least one post-baseline assessment for BCVA in the study eye. Last observation carried forward (LOCF) was utilized.||Letters||Standard Deviation|Mean
735569|NCT00436566|Secondary|Incidence of Pulmonary Events|Pulmonary events to be included were grade 3 and higher pulmonary adverse events at least possibly related to study treatment, which occur at any time after post-AC treatment is begun, but prior to documentation of a breast cancer recurrence, contralateral breast cancer, secondary primary cancer, non-pulmonary death, or pulmonary death not related to study treatment.|5 years||||||
735570|NCT00436566|Secondary|Quality-of-life||5 years||||||
735571|NCT00436566|Secondary|Comparison of Selected Quality-of-life Questionnaires||5 years||||||
735572|NCT00436566|Secondary|Overall Survival (OS)|OS was defined as the time from registration to death of any cause. Participants were followed for a maximum of 5 years from randomization. The median OS with 95%CI was estimated using the Kaplan Meier method.|5 years||||||
735573|NCT00436566|Secondary|Disease-free Survival (DFS)|DFS was defined as the time from registration to the earliest date of documentation of any local, regional, or distant recurrence of breast cancer (BC); the development of a contralateral BC or second primary other than squamous or basal cell carcinoma of the skin, carcinoma in situ of the cervix, or lobular carcinoma in situ of the breast; or death from any cause without the documentation of one of these events. Participants were followed for a maximum of 5 years from randomization. The median OS with 95%CI was estimated using the Kaplan Meier method.|5 years||||||
735574|NCT00436566|Secondary|Number of Patients Who Experience >= 10 Percent Drop in Left Ventricular Ejection Fraction (LVEF) Between Two Time Points||5 years||||||
735575|NCT00436566|Secondary|Cumulative Incidence (CI) of Cardiac Events|"Evaluable patients included those completed the AC phase of their treatment regimen; with post AC cardiac evaluation indicates they are eligible to begin treatment with PTL; and those have begun their post-AC therapy.
Cardiac events: symptomatic congestive heart failure (CHF), cardiac death and other cardiac events (NCI Common Terminology Criteria for Adverse Events (CTCAE) Grade >=3)"|5 years||||||
735579|NCT00436605|Primary|Number of Subjects With Objective Response(Partial Response and Complete Response) as Measured by RECIST Criteria|Only those patients who have measurable disease present at baseline, have received at least one course of therapy, and have had their disease re-evaluated will be considered evaluable for response. A Simon’s optimum two-stage design will be used.|After every 8 weeks (or 2 courses), assessed up to 4 weeks after completion of treatment|||participants|||Number
735580|NCT00436618|Secondary|Time to Progression|The time to progression is defined as the time from registration to the time of progression. The distribution of time to progression was estimated using the method of Kaplan-Meier.|5 years|276 out of 277 were analyzed for response. One patient was excluded because of patient refusal before starting treatment.||years||95% Confidence Interval|Median
735581|NCT00436618|Secondary|Progression-free Survival|"Progression-free survival is defined as the time from registration to the time of progression or death due to any cause. Progression-free survival was estimated using the method of Kaplan-Meier.
Progression is defined as the following:
CLL (subset of patients in the Relapsed Indolent Non-Hodgkin Lymphoma group): >=50% increase in nodes from nadir or >=50% increase in liver/spleen size from nadir.
Waldenstrom (subset of patients in the Uncommon Lymphomas group): >50% lymph node increase in SPD of > 1 node or new nodes, or >50% liver/spleen size increase, or > 25% IgM (by SPEP) increase, or lymphocyte morphology transformation to a more aggressive histology.
All Others: New lesions or >=50% lymph nodes."|5 years|276 out of 277 were analyzed for response. One patient was excluded because of patient refusal before starting treatment.||years||95% Confidence Interval|Median
735582|NCT00436618|Secondary|Overall Survival|The overall survival or survival time is defined as the time from registration to death due to any cause. The distribution of overall survival was estimated using the method of Kaplan-Meier.|5 years|276 out of 277 were analyzed for response. One patient was excluded because of patient refusal before starting treatment.||years||95% Confidence Interval|Median
735583|NCT00436618|Primary|Tumor Response, Defined by Disease: Chronic Lymphocytic Leukemia(CLL): Clinical Complete or Complete or Nodular Partial or Partial Remission, Waldenstrom: Complete or Partial Response, All Others: Complete or Complete Unconfirmed or Partial Response.|"CLL (subset of patients in the Relapsed Indolent Non-Hodgkin Lymphoma group): 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence/absence of constitutional symptoms; plus ≥1 of the following: ≥1500/μL polymorphonuclear leukocytes, >100000/μL platelets, >11.0 g/dL hemoglobin or 50% improvement for these parameters without transfusions.
Waldenstrom (subset of patients in the Uncommon Lymphomas group): >50% reduction in serum immunoglobulin M(IgM) levels (by serum protein electrophoresis (SPEP)) during any point while in this study, and no appearance of new lesions.
All others: at least a 50% decrease in the sum of the products of the greatest diameters (SPD) of the six largest dominant nodes or nodal masses and no increase in the size of other nodes, liver, or spleen and splenic and hepatic nodules must regress by at least 50% in the SPD and no new sites of disease."|5 years|276 out of 277 were analyzed for response. One patient was excluded because of patient refusal before starting treatment.||percentage of patients in group||95% Confidence Interval|Number
735584|NCT00436644|Secondary|Overall Survival|Overall survival time was defined as the number of months from registration to the date of death or last follow-up|Time from Registration to Death or last follow-up (up to 3 years)|||months||95% Confidence Interval|Median
735585|NCT00436644|Secondary|Adverse Event Profile|Number of patients that experienced adverse events (grade 3 or more) as measured by NCI CTCAE (Common Terminology Criteria for Adverse Events) v3.0|Every 4 weeks|||participants|||Number
735586|NCT00436644|Secondary|Time to Progression|Time to progression was defined as the number of months from registration to the date of disease progression, with patients who are progression free being censored on the date of their last evaluation.|Time from registration to progression (up to 2 years)|||months||95% Confidence Interval|Median
735587|NCT00436644|Primary|Response Rate (Complete Response (CR) or Partial Response (PR))|"Measurable disease patients: measureable disease is defined as at least one lesion whose longest diameter >= 2cm with conventional techniques or >=1cm with spiral CT
Confirmed tumor response (complete and partial) as measured by RECIST(Response Evaluation Criteria In Solid Tumors) criteria on 2 consecutive evaluations at least 4 weeks apart.
Confirmed tumor response is at least a 30% decrease in the sum of the longest diameter of target lesions and no new lesions.
Non-measurable disease patients:
Decrement in CA125 by > 50%
Improvement in other evaluable disease"|Two consecutive evaluations at least 4 weeks apart|||participants|||Number
735588|NCT00437983|Secondary|Change From Baseline in Rey Osterrieth Complex Figure Test|A widely used neuropsychological tool for the evaluation of visuospatial constructional ability and visual memory. Both the time to complete the task (copy time)and the accuracy (immediate and delayed recall) were used as measures for the analysis. Accuracy range score is 0-36 points (0 is worse, 36 is best). Copy time is expressed in seconds (less time to copy indicates better performance).|baseline, 15 weeks|Analysis of per-protocol (PP) cohort. Out of the 131 participants who completed the study, nine were excluded from the PP analysis (5 from the placebo group and 4 from the PS-omega3 group), one due to short interval between visits and the rest didn't meet the compliance criteria (≥ 65%).||Units on a scale||Standard Error|Mean
735589|NCT00437983|Secondary|Clinical Global Impression of Change (CGI-C)Scale|The Clinical Global Impression of Change (CGI-C)scale is designed to record the clinician’s global impression of change. Global improvement score ranges from 1 = “Very much improved”, through 4 = “No change”, to 7 = “Very much worse”. Participants who experienced an improvement (scores 1, 2 or 3) in at least one of the two visits (following 7 or 15 weeks of treatment) were classified as improved over the treatment period (with the exception of participants reporting improvement following 7 weeks and deterioration at endpoint, who were NOT rated as improved)|7 weeks, 15 weeks|Analysis of per-protocol (PP) cohort. Out of the 131 participants who completed the study, nine were excluded from the PP analysis (5 from the placebo group and 4 from the PS-omega3 group), one due to short interval between visits and the rest didn't meet the compliance criteria (≥ 65%).||Participants who experienced improvement|||Number
735590|NCT00437983|Secondary|Computerized Cognitive Assessment Tool||baseline, 15 weeks||||||
735591|NCT00437983|Secondary|Trail Making Test||Baseline, 15 weeks||||||
735592|NCT00437983|Secondary|Blood Work||baseline,15 wk||||||
735689|NCT00438880|Secondary|Duration of Response|Duration of response (DoR) will be calculated from the documentation of response until the date of progression in the subset of patients who respond.|Up to 1 year from treatment start date|The duration of response was not analyzed due to a lack of more than one response.|||||
735593|NCT00437983|Primary|Change From Baseline in Rey Auditory Verbal Learning Test|A widely used, brief, easy to understand scale to evaluate verbal learning and memory. The score is presented as the number of words correctly recalled (0 is worse, 15 is best).The total learning task score ranges from 0 to 45 words(0 is worse, 45 is best).|baseline, 15 wk|Analysis of per-protocol (PP) cohort. Out of the 131 participants who completed the study, nine were excluded from the PP analysis (5 from the placebo group and 4 from the PS-omega3 group), one due to short interval between visits and the rest didn’t meet the compliance criteria (≥ 65%).||number of words correctly recalled||Standard Error|Mean
735594|NCT00438100|Secondary|Survival Rate||The follow up period will be two years after the last dose has been administered.||||||
735595|NCT00438100|Secondary|Time to Treatment Failure||The follow up period will be two years after the last dose has been administered.||||||
735596|NCT00438100|Secondary|Antitumor Effects||The follow up period will be two years after the last dose has been administered.||||||
735597|NCT00438100|Secondary|Adverse Events||The follow up period will be two years after the last dose has been administered.||||||
735598|NCT00438100|Primary|Progression Free Survival||The follow up period will be two years after the last dose has been administered.|||years||95% Confidence Interval|Median
735599|NCT00438191|Secondary|Pain Intensity|Pain intensity was measured using the Numeric Rating Scale, on a scale from 0-10, where 0 is no pain and 10 is the most pain.|8 weeks|||units on a scale||Standard Deviation|Mean
735600|NCT00438191|Secondary|Treatment Satisfaction|Treatment satisfaction was measured on a scale from 0-10, where 0 is complete dissatisfaction and 10 is complete satisfaction|8 weeks|||units on a scale||Standard Deviation|Mean
735601|NCT00438191|Secondary|Grip Strength|Grip strength is measured as a percentage of the non-affected or least affected side.|8 weeks|||percentage of non-affected hand||Standard Deviation|Mean
735602|NCT00438191|Primary|Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire|The DASH questionnaire measures upper extremity disability on a scale from 0-100, where 0 is no disability and 100 is severe disability.|8 weeks|||units on a scale||Standard Deviation|Mean
735603|NCT00438204|Secondary|Overall Survival||Every 8 weeks, for up to 54 months||||||
735604|NCT00438204|Secondary|Time to Treatment Failure||Every 8 weeks, for up to 54 months||||||
735605|NCT00438204|Secondary|Toxicity||Every two weeks, for up to 54 months||||||
735606|NCT00438204|Secondary|Response Rate||Every 8 weeks, for up to 54 months||||||
735607|NCT00438204|Primary|Progression-free Survival (PFS)|RECIST criteria for tumor progression of at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).|Up to 12 months|||months||90% Confidence Interval|Median
735608|NCT00438360|Secondary|Safety / Tolerability Assessed by Adverse Events||24weeks||||||
735609|NCT00438360|Secondary|Change From Baseline in Visual Analogue Scale (VAS) for Patient Self Assessment of Pruritus|Target lesion pruritus as measured by the Visual Analog Scale (VAS) from 0 to 100 mm at week 24 compared to baseline (with 0 being no pruritis and 100 being maximum pruritis).|Baseline and week 24|Intent to treat (ITT) population. Patients with a value of VAS at baseline and 24 weeks were included in this analysis.||Units on a scale||Standard Deviation|Mean
735610|NCT00438360|Secondary|Change From Baseline in Body Surface Area (BSA) Affected by Psoriasis|BSA is a measure of the percentage of body surface affected by psoriasis. Using the Mosteller Formula: BSA = BSA (m²) = ( [Height(in) x Weight(lbs) ]/ 3131 )½ . A covariance analysis was performed on all variables, with value assessed at visit 2 as covariate and center as effect. For each variable the changes versus the last available measures were computed|Baseline and week 24|Intent to Treat (ITT) population. Patients with a value of BSA at baseline and 24 weeks were included in this analysis.||BSA (m^2)||Standard Deviation|Mean
735611|NCT00438360|Secondary|Change From Baseline in Psoriasis Area and Severity Index (PASI) Score|PASI is an index used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 (best) to 72 (worst), with the highest score representing complete erythroderma of the severest degree.|baseline and week 24|Intention to treat (ITT) population. Patients with a value of PASI at baseline and 24 weeks were included in this analysis.||Units on a scale||Standard Deviation|Mean
735612|NCT00438360|Secondary|Proportion of Participants With Clinical Relapse|Clinical relapse was defined as worsening of psoriasis associated with a Psoriasis Area and Severity Index (PASI) >75% of the PASI score assessed before the continuous treatment, or when the investigator or the patient judged it necessary to change the treatment.|24 weeks|Intent to treat population.||proportion of participants|||Number
735613|NCT00438360|Primary|Number of Participants With Relapse Rate (Success or Failure), as Assessed by Psoriasis Area and Severity Index (PASI) Score|PASI is an index used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 (best) to 72 (worst), with the highest score representing complete erythroderma of severest degree. Relapse is considered a worsening of psoriasis associated to a PASI score >75% of PASI score recorded before starting induction therapy with CsA (before study start). Each patient was considered as failure (relapse occurrence) if rate was >= 75%. In all the other cases the patient was considered as success (no relapse).|24 weeks|Intent to treat population.||Participants|||Number
735614|NCT00438399|Primary|Percentage of Subjects Preffering Clobetasol Propionate Shampoo Better Than Comparator|"Subjects’ Overall preference at the end of Period II. The purpose was to demonstrate a superiority of Clobetasol propionate shampoo 0.05% therapy compared to any of three other topical comparators, in terms of subject's overall preference: C. propionate shampoo a lot better than the comparator,C. propionate shampoo a lillte bit better than the comparator, Comparator a lot better than C. propionate shampoo, Comparator a lillte bit better than C. propionate shampoo. This was to be shown using a non parametric two-sided Wilcoxon rank Signed test, on Intention to Treat (ITT) population."|End of period II (up to 16 weeks)|Intent to Treat population (ITT).||Percentage of participants|||Number
735615|NCT00438451|Secondary|Results of Cognitive Testing (EpiTrack© by UCB) - Changes to Baseline (V0) at Week 58 (V6)|"Evaluation of Changes
Changes in the EpiTrack® Score were categorized as follows:
≥5 score points: Improved;
-3 to 4 score points: Unchanged;
≤-4 score points: Worsened"|week 58|Patients of ITT population with data at V6 and V0||participants|||Number
735617|NCT00438451|Secondary|Results of Cognitive Testing (EpiTrack© by UCB) - Score at V6|EPITrack-Score shows the performance of attention and executive functions. Higher values indicate a better performance. The results of EPITrack Score ranges between 7 and 45.|week 58|Patients of ITT population who had data at V6||units on a scale||Standard Deviation|Mean
735618|NCT00438451|Secondary|Portland Neurotoxicity Scale (PNS) at V6|"The PNS is a 15-item scale. Each item can be scored from 1 to 9. There are a total score (includes all items, range:15 to 135) and two subscores: The cognitive toxicity subscore (10 items: Energy Level, Memory, Interest, Concentration, Forgetfulness, Sleepliness, Moodiness, Alertness, Attention Span, Motivation, range:10 to 90) and the somatomoto subscore (5 items: Vision, Walking, Coordination, Tremor, Speech, range:5-45). The score is calculated by taking the mean of all non-missing values times the number of items.
Lower values indicate better quality of life."|at week 58|Patients of ITT population who filled out PNS at V6||units on a scale||Standard Deviation|Mean
735619|NCT00438451|Secondary|QOLIE-31 (Quality Of Life In Epilepsy) Results at V6|The QOLIE-31 is a 31 item score that measures the quality of life in epilepsy (each item with a range of 0 to 100). There are 7 sub-scores seizure worry (items 11,21,22,23,25), overall quality of life (items 1,14), emotional well-being (items 3,4,5,7,9), energy/fatigue (items 2,6,8,10), cognitive functioning (items 12,15,16,17,18,26), medication effects (items 24,29,30) and social functioning (13,19,20,27,28). These scores were combined to a total score by Total score = seizure worry*0.08 + overall quality of life*0.14 + emotional well-being*0.15 + energy/fatigue*0.12 + cognitive functioning*0.27 + medication effects*0.03 + social functioning*0.21 For all scores, higher values indicate better quality of life. Each score has a possible range from 0 to 100.|58 weeks, final visit|Patients of ITT population who filled out QOLIE-31 at V6||units on a scale||Standard Deviation|Mean
735620|NCT00438451|Secondary|Proportion of Seizure-free Days During the Maintenance Phase for Subjects Who Enter the Maintenance Phase||52 weeks|Patients of ITT population who reached the maintenance phase||proportion of seizure-free days|||Number
735621|NCT00438451|Secondary|The Absolute Seizure Frequency During the Maintenance Phase (Weeks 7 - 58)|"Seizure frequency was assessed by investigators in the CRF at the Visits V3, V4, V5 and V6.
The absolute seizure frequency during the maintenance phase was defined as the sum of those entries."|over 52 weeks|"Completer population:
The completer population comprises all patients still being in the study at week 58 (This definition deviates minimally from the protocol. It could not be assessed from the CRF data, if patients were on treatment)."||number of seizures|||Number
735622|NCT00438451|Secondary|The Time (in Days) to First Break-through Seizure (From Day 1 of Treatment)||over the whole duration of 58 weeks|"ITT population:
All randomized patients were included in the Intention-to-Treat (ITT) population except patients that were not evaluable for efficacy e.g. patients without epilepsy or patients not able to comply with the study requirements."||days||95% Confidence Interval|Median
735623|NCT00438451|Secondary|Percentage of Patients Remaining Seizure Free at Week 58 (Visit 6)|Percentage of patients experiencing no seizures until week 58 (Visit 6) and did not discontinue the study until week 58.|week 58|"ITT population:
All randomized patients were included in the Intention-to-Treat (ITT) population except patients that were not evaluable for efficacy e.g. patients without epilepsy or patients not able to comply with the study requirements."||percentage of participants|||Number
735624|NCT00438451|Secondary|Percentage of Patients Remaining Seizure-free at Week 30 (Visit 4)|Percentage of patients experiencing no seizures until week 30 (Visit 4) and did not discontinue the study until week 30.|Week 30|"ITT population:
All randomized patients were included in the Intention-to-Treat (ITT) population except patients that were not evaluable for efficacy e.g. patients without epilepsy or patients not able to comply with the study requirements."||percentage of participants|||Number
735625|NCT00438451|Secondary|Time to Drop Out|number of days between randomization and premature discontinuation of the study|58 weeks|"ITT population:
All randomized patients were included in the Intention-to-Treat (ITT) population except patients that were not evaluable for efficacy e.g. patients without epilepsy or patients not able to comply with the study requirements."||days||95% Confidence Interval|Median
735626|NCT00438451|Primary|58-week Retention Rate Measured by the Number of Drop Outs Due to Adverse Events or Seizures From Day 1 of Treatment||58 weeks|"ITT population:
All randomized patients were included in the Intention-to-Treat (ITT) population except patients that were not evaluable for efficacy e.g. patients without epilepsy or patients not able to comply with the study requirements."||proportion of participants||95% Confidence Interval|Mean
735627|NCT00438464|Secondary|Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Within Placebo Treatment Arm for Biomarker Subgroups|Molecular marker expression compared between tumor foci, characteristics of blood biomarkers using pretreatment and posttreatment values. VEGF denotes vascular epithelial growth factor, ERβ estrogen receptor beta, AR androgen receptor, SRD5A2, 3-oxo-5α-steroid 4-dehydrogenase 2, UBE2C, ubiquitin-conjugating enzyme E2C. P values are based on non-parametric Wilcoxon rank-sum test.|At prostatectomy following maximum 6 week treatment period.|Of total 94 enrolled participants in the Placebo Arm, 68 participants had either a qualifying tumor specimen with GG3 or GG4. Differences in number (N) of tissue specimens (tumor foci) is based on feasibility of subgroup participants' radical prostatectomy samples analyzed.||Percentage of tumor cell involvement||Full Range|Median
735628|NCT00438464|Secondary|Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Finasteride Treatment Arm for Biomarker Subgroups|Molecular marker expression compared between tumor foci, characteristics of blood biomarkers using pretreatment and posttreatment values. VEGF denotes vascular epithelial growth factor, ERβ estrogen receptor beta, AR androgen receptor, SRD5A2, 3-oxo-5α-steroid 4-dehydrogenase 2, UBE2C, ubiquitin-conjugating enzyme E2C. P values are based on non-parametric Wilcoxon rank-sum test.|At prostatectomy following maximum 6 week treatment period|Of total 89 enrolled participants in the Finasteride Arm, 62 participants had either a qualifying tumor specimen with GG3 or GG4. Differences in number (N) of tissue specimens (tumor foci) is based on feasibility of subgroup participants' radical prostatectomy samples analyzed.||Percentage of tumor cell involvement||Full Range|Median
735636|NCT00438464|Secondary|Characteristics of Blood Biomarkers: Estrone (ng/dL) Percentage Change|Characteristics of blood biomarkers using pretreatment and posttreatment values. Blood test used to measure Estrone (E1), one of the three estrogens, which also includes estriol and estradiol.|Baseline biopsy to prostatectomy following maximum 6 week treatment period|Analysis includes all evaluable participants.||percentage of change||Full Range|Median
735629|NCT00438464|Secondary|Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Placebo Treatment Arm for Biomarker Subgroups (Mean)|Molecular marker expression compared between tumor foci, characteristics of blood biomarkers using pretreatment and posttreatment values. VEGF denotes vascular epithelial growth factor, ERβ estrogen receptor beta, AR androgen receptor, SRD5A2, 3-oxo-5α-steroid 4-dehydrogenase 2, UBE2C, ubiquitin-conjugating enzyme E2C.|At prostatectomy following maximum 6 week treatment period.|Of total 94 enrolled participants in the Placebo Arm, 68 participants had either a qualifying tumor specimen with GG3 or GG4. Differences in number (N) of tissue specimens (tumor foci) is based on feasibility of subgroup participants' radical prostatectomy samples analyzed.||Percentage of tumor cell involvement||Standard Deviation|Mean
735630|NCT00438464|Secondary|Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Finasteride Treatment Arm for Biomarker Subgroups (Mean)|Molecular marker expression compared between tumor foci, characteristics of blood biomarkers using pretreatment and posttreatment values. VEGF denotes vascular epithelial growth factor, ERβ estrogen receptor beta, AR androgen receptor, SRD5A2, 3-oxo-5α-steroid 4-dehydrogenase 2, UBE2C, ubiquitin-conjugating enzyme E2C.|At prostatectomy following maximum 6 week treatment period|Of total 89 enrolled participants in the Finasteride Arm, 62 participants had either a qualifying tumor specimen with GG3 or GG4. Differences in number (N) of tissue specimens (tumor foci) is based on feasibility of subgroup participants' radical prostatectomy samples analyzed.||Percentage of tumor cell involvement||Standard Deviation|Mean
735631|NCT00438464|Primary|Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy|Molecular marker expression compared between tumor foci using biomarkers pretreatment and posttreatment values. Staining microarrays for high-throughput assessment of candidate gene expression and data modeling constructed with a tissue microarray apparatus and 0.6-mm biopsy cores, representative of tumor grades and scores (Gleason Grades 3 (GG3) and Gleason Grade 4 (GG4)). The percentage of tumor cells exhibiting detectable staining, scored as 0 to 10 where higher score designates more involvement, as applicable for: VEGF denotes vascular epithelial growth factor, ERβ estrogen receptor beta, AR androgen receptor, SRD5A2, 3-oxo-5α-steroid 4-dehydrogenase 2, UBE2C, ubiquitin-conjugating enzyme E2C.|At prostatectomy following maximum 6 week treatment period.|Of total 183 enrolled participants in both arms, 62 Finasteride and 68 Placebo participants respectively had a qualifying tumor specimen with GG3 or GG4. Differences in number (N) of tissue specimens (tumor foci) is based on feasibility of subgroup participants' radical prostatectomy samples analyzed.||Percentage of tumor cell involvement||Standard Deviation|Mean
735632|NCT00438464|Primary|Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy|Molecular marker expression compared between tumor foci using Biomarkers pretreatment and posttreatment values. Staining microarrays for high-throughput assessment of candidate gene expression and data modeling constructed with a tissue microarray apparatus and 0.6-mm biopsy cores, representative of tumor grades and scores (Gleason Grades 3 (GG3) and Gleason Grade 4 (GG4)). The percentage of tumor cells exhibiting detectable staining, scored as 0 to 10 where higher score designates more involvement, as applicable for: VEGF denotes vascular epithelial growth factor, ERβ estrogen receptor beta, AR androgen receptor, SRD5A2, 3-oxo-5α-steroid 4-dehydrogenase 2, UBE2C, ubiquitin-conjugating enzyme E2C.|At prostatectomy following maximum 6 week treatment period.|Of total 183 enrolled participants in both arms, 62 Finasteride and 68 Placebo participants respectively had a qualifying tumor specimen with GG3 or GG4. Differences in number (N) of tissue specimens (tumor foci) is based on feasibility of subgroup participants' radical prostatectomy samples analyzed.||Percentage of tumor cell involvement||Standard Deviation|Mean
735633|NCT00438464|Primary|Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy|Biomarkers using pretreatment and posttreatment values. Staining microarrays for high-throughput assessment of candidate gene expression and data modeling constructed with a tissue microarray apparatus and 0.6-mm biopsy cores, representative of tumor grades and scores (Gleason Grades 3 (GG3) and Gleason Grade 4 (GG4)). The percentage of tumor cells exhibiting detectable staining, scored as 0 to 10 where higher score designates more involvement, as applicable for: VEGF denotes vascular epithelial growth factor, ERβ estrogen receptor beta, AR androgen receptor, SRD5A2, 3-oxo-5α-steroid 4-dehydrogenase 2, UBE2C, ubiquitin-conjugating enzyme E2C. P values are based on non-parametric Wilcoxon rank-sum test.|At prostatectomy following maximum 6 week treatment period|Of total 183 enrolled participants in both arms, 62 Finasteride and 68 Placebo participants respectively had a qualifying tumor specimen with GG3 or GG4. Differences in number (N) of tissue specimens (tumor foci) is based on feasibility of subgroup participants' radical prostatectomy samples analyzed.||Percentage of tumor cell involvement||Full Range|Median
735634|NCT00438464|Primary|Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy|Molecular marker expression based on tissue microarray (TMA) derived from dominant tumor focus. Staining microarrays for high-throughput assessment of candidate gene expression and data modeling constructed with a tissue microarray apparatus and 0.6-mm biopsy cores, representative of tumor grades and scores (Gleason Grades 3 (GG3) and Gleason Grade 4 (GG4)). The percentage of tumor cells exhibiting detectable staining, scored as 0 to 10 where higher score designates more involvement, as applicable for: vascular epithelial growth factor (VEFG), estrogen receptor beta (ERβ), androgen receptor (AR), 3-oxo-5α-steroid 4-dehydrogenase 2 (SRD5A2), ubiquitin-conjugating enzyme E2C (UBE2C), and Cleaved Caspase 3 (Caspase). P values are based on non-parametric Wilcoxon rank-sum test.|At prostatectomy following maximum 6 week treatment period|Of total 183 enrolled participants in both arms, 62 Finasteride and 68 Placebo participants respectively had a qualifying tumor specimen with GG3 or GG4. Differences in number (N) of tissue specimens (tumor foci) is based on feasibility of subgroup participants' radical prostatectomy samples analyzed.||Percentage tumor cell involvement||Full Range|Median
735635|NCT00438464|Secondary|Characteristics of Blood Biomarkers: Estradiol (ng/dL) Percentage Change|Characteristics of blood biomarkers using pretreatment and posttreatment values. Blood test used to measure Estradiol.|Baseline biopsy to prostatectomy following maximum 6 week treatment period|Analysis includes all evaluable participants.||percentage of change||Full Range|Median
735637|NCT00438464|Secondary|Characteristics of Blood Biomarkers: Dihydrotestosterone (ng/dL) Percentage Change|Characteristics of blood biomarkers using pretreatment and posttreatment values. Dihydrotestosterone (DHT) blood test measures serum concentrations of dihydrotestosterone and is closely related to those of testosterone.|Baseline biopsy to prostatectomy following maximum 6 week treatment period|Analysis includes all evaluable participants.||percentage of change||Full Range|Median
735638|NCT00438464|Secondary|Characteristics of Blood Biomarkers: Testosterone (ng/dL) Percentage Change|Characteristics of blood biomarkers using pretreatment and posttreatment values. Blood tests used for measuring the amount of testosterone in the blood.|Baseline biopsy to prostatectomy following maximum 6 week treatment period|Analysis includes all evaluable participants.||percentage of change||Full Range|Median
735639|NCT00438464|Secondary|Characteristics of Blood Biomarkers: Prostate-specific Antigen (ng/mL) Percentage Change (%)|Characteristics of blood biomarkers using pretreatment and posttreatment values. Prostate-specific antigen (PSA) blood test measuring protein produced by prostate cells.|Baseline biopsy to prostatectomy following maximum 6 week treatment period|Analysis includes all evaluable participants.||percentage of change||Full Range|Median
735640|NCT00438464|Secondary|Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Tumor Volume (Cubic Centimeter)|Characteristics of tumor considering total zone cancer volume, and cancer volume using zonal foci categorized as: PZ, peripheral zone; TZ, transition zone; CZ, central zone.|Baseline biopsy to prostatectomy following maximum 6 week treatment period|Analysis includes all evaluable participants.||cubic centimeter||Full Range|Median
735641|NCT00438464|Secondary|Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Upgrade Between Biopsy and Prostatectomy|Change in Gleason Score from biopsy to prostatectomy where an upgrade refers to a higher Gleason Score signifying worsening of tumor. Gleason scoring (GS) to based on microscopic appearance using 2005 International Society of Urological Pathologists recommendation.|Baseline biopsy to prostatectomy following maximum 6 week treatment period|Analysis includes all evaluable participants.||participants|||Number
735642|NCT00438464|Secondary|Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Zonal Origin -- Dominant Tumor Focus|Dominant tumor focus, distribution within zones of the prostate using radical prostatectomy specimen (RPS) where number of foci categorized by zone defined as: PZ, peripheral zone; TZ, transition zone; CZ, central zone. Dominant tumor focus is the largest, index lesion, single high risk focus of the prostate cancer.|Assessment following maximum 6 week treatment period and prostatectomy|Analysis includes all evaluable participants.||participants|||Number
735643|NCT00438464|Secondary|Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Zonal Origin of Tumor Foci Per Radical Prostatectomy Specimen (RPS)|Tumor distribution within zones of the prostate using radical prostatectomy specimen (RPS) where number of foci categorized by zone defined as: PZ, peripheral zone; TZ, transition zone; CZ, central zone.|Assessment following maximum 6 week treatment period and prostatectomy|Analysis includes all evaluable participants.||participants|||Number
735644|NCT00438464|Secondary|Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Cancer Foci|Diagnosis of a small focus of prostatic adenocarcinoma on a prostate needle biopsy from pathologist's identification of an architecturally abnormal focus of epithelial structures at rather low magnification.|Assessment following maximum 6 week treatment period and prostatectomy|Analysis includes all evaluable participants.||participants|||Number
735645|NCT00438464|Secondary|Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Lymph Node Status|Status of cancer spread to lymph nodes; PN0 Cancer that has not spread to the lymph nodes. Cancer that has not spread to the lymph nodes. The N category describes whether the cancer has spread into nearby lymph nodes. NX means the nearby lymph nodes cannot be evaluated. N0 means nearby lymph nodes do not contain cancer. Numbers after the N (such as N1, N2, and N3) describe the size, location, and/or the number of nearby lymph nodes affected by cancer. The higher the N number, the greater the cancer spread to nearby lymph nodes.|Assessment following maximum 6 week treatment period and prostatectomy|Analysis includes all evaluable participants.||participants|||Number
735646|NCT00438464|Secondary|Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Margin of Resection (MOR)|Edge or border of tissue removed in cancer surgery. The margin is described as negative or clean when the pathologist finds no cancer cells at the edge of the tissue, suggesting that all of the cancer has been removed. The margin is described as positive or involved when the pathologist finds cancer cells at the edge of the tissue, suggesting that all of the cancer has not been removed.|Assessment following maximum 6 week treatment period and prostatectomy|Analysis includes all evaluable participants.||participants|||Number
735647|NCT00438464|Secondary|Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Tumor, Node, Metastasis (TNM) Stage|American Joint Committee on Cancer (AJCC) system 6th edition (2002) describing amount and spread of cancer body, using TNM. T describes the size of the tumor and any spread of cancer into nearby tissue; N describes spread of cancer to nearby lymph nodes; and M describes metastasis (spread of cancer to other parts of the body). Numbers after the T (such as T1, T2, T3, and T4) describe tumor size and/or amount of spread into nearby structures. The higher the T number, the larger the tumor and/or the more it has grown into nearby tissues where T3a reflects tumor has spread through the capsule on one or both sides; and T3b reflects tumor has invaded one or both seminal vesicles.|Assessment following maximum 6 week treatment period and prostatectomy|All evaluable participants.||participants|||Number
735648|NCT00438464|Secondary|Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Grade -- Specimen (Secondary)|Frequency of Grade 3, Grade 4 and Grade 5 tumors in two treatment groups: Participants will consist of men with adenocarcinoma of the prostate, clinical stage T1c or T2, with a Gleason score of 6 or 7 and a PSA level < 10 ng/mL, who are scheduled to undergo prostatectomy.|Assessment following maximum 6 week treatment period and prostatectomy|Analysis includes all evaluable participants. One participant in each arm was excluded due to hormonal therapy effect resulting in lack of assignment of Gleason Grade.||participants|||Number
735669|NCT00438750|Secondary|Pinch Strength|"Pinch strength measured with the B&L pinch gauge.
B&L Engineering is the official name of the company (nowhere is there an expansion of this acronym)."|6 months|||Pounds (lbs)||Standard Deviation|Mean
735670|NCT00438750|Secondary|10-point Ordinal Pain Scale|A ten point scale for pain at rest, with 0 as no pain and 10 as worst pain ever.|6 months|||units on a scale||Standard Deviation|Mean
735649|NCT00438464|Secondary|Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Grade -- Specimen (Primary)|Frequency of Grade 3 and Grade 4 tumors in two treatment groups: Participants consist of men with adenocarcinoma of the prostate, clinical stage T1c or T2, with a Gleason score of 6 or 7 and a PSA level < 10 ng/mL, who are scheduled to undergo prostatectomy.|Assessment following maximum 6 week treatment period and prostatectomy|Analysis includes all evaluable participants. One participant in each arm was excluded due to hormonal therapy effect resulting in lack of assignment of Gleason Grade.||participants|||Number
735650|NCT00438464|Secondary|Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Score|Frequency of Grade 3 and Grade 4 tumors in two treatment groups: Participants consist of men with adenocarcinoma of prostate, clinical stage T1c or T2, with Gleason score of 6 or 7 and PSA level < 10 ng/mL, who are scheduled to undergo prostatectomy. 2005 International Society of Urological Pathologists recommendations for Gleason scoring (GS) used to grade tumors based upon its microscopic appearance: a primary grade is assigned to most common tumor pattern, and a second grade to next most common tumor pattern. Gleason score (GS) is sum of the two Gleason grades, based on scale of 2-10 with lowest numbers indicating slow-growing tumor unlikely to spread and highest numbers indicating an aggressive tumor. Gleason grade = 1-5; Gleason score = 2-10; 5 and 10 indicate worst prognosis. American Joint Committee on Cancer (AJCC) staging describes extent of disease progression utilizing TNM scoring system: Tumor size, Lymph Nodes affected, Metastases. Higher stage cancers are more advanced.|Assessment following maximum 6 week treatment period and prostatectomy|Analysis includes all evaluable participants. One participant in each arm was excluded due to hormonal therapy effect resulting in lack of assignment of Gleason Grade.||participants|||Number
735651|NCT00438490|Secondary|Reproductive Hormones-LH, FSH, Estradiol||7 days||||||
735652|NCT00438490|Secondary|Menstrual Cycle Length||28 days||||||
735653|NCT00438490|Secondary|Bone Turnover-deoxypyridinoline, N-telopeptide, Bone Specific Alkaline Phosphatase||7 days||||||
735654|NCT00438490|Primary|Galactorrhea|Galactorrhea is breast milk production.|7 days|||percentage of participants|||Number
735655|NCT00438659|Secondary|Adverse Events Reported by the Patient in the Symptom Experience Diary (SED).|Maximum SED score during radiation treatment per patient on a 0 to 10 scale (lower score is better)|During Radiation Treatment, up to a maximum of 11 weeks.|||units on a scale||Standard Deviation|Mean
735656|NCT00438659|Secondary|Adverse Events Assessed Clinically by NCI CTCAE v3.0||During Radiation Treatment, up to a maximum of 9 weeks.|||participants|||Number
735657|NCT00438659|Secondary|QOL Domains as Measured by LASA|Mean scores of Linear Analogue Sef-Assessment (LASA) Mental, physical, emotional, social, spiritual wel-being on a 0 (as bad as it can be) to 100 (as good as it can be) scale.|During Radiation Treatment, up to a maximum of 11 weeks.|Patients who completed at least 1 assessment were evaluable for this secondary end point.||units on a scale||Standard Deviation|Mean
735658|NCT00438659|Secondary|Overall Quality of Life (QOL) as Measured by Linear Analogue Self-Assessment (LASA)|Patient completed QOL assessment was the Linear Analogue Self-Assessment (LASA). This instrument consisted of 6 questions with responses ranging from 0 (poor QOL) to 100 (best QOL).|During Radiation Treatment, up to a maximum of 11 weeks.|Patients who completed at least 1 assessment were evaluable for this secondary end point.||units on a scale||Standard Deviation|Mean
735659|NCT00438659|Secondary|Duration of Severe (Grade ≥ 3) Radiation Dermatitis as Measured by the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. This Analysis Was Not Completed Due to Too Little Incidence of the Dermatitis.|To compare time to onset and duration of severe (Grade ≥ 3) radiation dermatitis as measured by the CTCAE v3.0 for the mometasone and placebo arms. This analysis was not completed due to too little incidence of the dermatitis.|During Radiation Treatment, up to a maximum of 9 weeks.|This analysis was not completed due to too little incidence of the dermatitis.|||||
735660|NCT00438659|Secondary|Skin Toxicity as Measured by a Dermatologic Quality-of-life Instrument (Skindex-16).|Patient-Reported Mean of the Maximum Total a Skindex-16 Toxicity Score per patient on a 0-6 scale during radiation treatment (Lower score indicates less toxicity).|During Radiation Treatment, up to a maximum of 11 weeks.|||score on a 0-6 scale||Standard Deviation|Mean
735661|NCT00438659|Secondary|Skin Toxicity as Measured by the Skin Toxicity Assessment Tool|Mean of the Maximum Patient Reported Skin Toxicity Assessment Tool (STAT) per patient on a 0 to 5 scale during radiation treatment. Lower scores indicate less toxicity.|During Radiation Treatment, up to a maximum of 9 weeks.|||Score on a 0 to 5 scale||Standard Deviation|Mean
735662|NCT00438659|Secondary|Incidence of Severe ( Grade >=3) Radiation Dermatitis|To compare incidence of severe (Grade ≥ 3) radiation dermatitis as measured by the CTCAE v3.0 for the mometasone and placebo arms.|During Radiation Treatment, up to a maximum of 9 weeks.|||Paticipants|||Number
735663|NCT00438659|Primary|Mean Maximum Grade of Radiation Dermatitis by Treatment Arm.|Maximum grade of radiation dermatitis as measured by the Common Terminology Criteria (CTCAE) for Adverse Events (AE), Version 3.0. Grade 1 (Mild AE), Grade 2 (Moderate AE), Grade 3 (Severe AE), Grade 4 (Life-threatening or disabling AE), Grade 5 (Death related to AE).|During Radiation Treatment, up to a maximum of 9 weeks.|||Grade||Full Range|Mean
735664|NCT00438672|Primary|Visual Analog Scale for Pain|Pain is measured on a 10 cm long line that starts at 0 on the left and ends with 10 on the right. A score of 0 represents no pain at all, and a score of 10 represents the worst pain ever. The individual score is measured using a measuring rod, measuring the distance from the left border in centimeters.|6 months|||units on a scale||Standard Deviation|Mean
735665|NCT00438672|Primary|Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire|The DASH questionnaire measures arm-specific perceived disability. It contains 30 items and is scaled between zero and 100 with higher scores indicating worse upper-extremity function.|6 months|||units on a scale||Standard Deviation|Mean
735666|NCT00438750|Secondary|Grip Strength|Measured with use of a grip meter as the average of three attempts.|6 months|||Pounds (lbs)||Standard Deviation|Mean
735667|NCT00438750|Secondary|Mayo Wrist Score|A composite score based on pain intensity, range of motion, grip strength, and functional status. The scale is as follows: below 60 is poor, 60-80 is satisfactory, 80-90 is good, and 90-100 is excellent.|6 months|||units on a scale||Standard Deviation|Mean
735668|NCT00438750|Secondary|Gartland and Werley Score|An objective evaluation of wrist function with 0 to 2 as excellent, 3-8 as good, 9-20 as fair, and 21 and above as poor range of motion.|6 months|||units on a scale||Standard Deviation|Mean
735671|NCT00438750|Secondary|Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire|"The DASH questionnaire measures arm-specific perceived disability. It contains 30 items and is scaled between zero and 100 with higher scores indicating worse upper-extremity function.
Mean and standard deviations are identical for both arms."|6 months|||units on a scale||Standard Deviation|Mean
735672|NCT00438750|Primary|Range of Motion in Degrees of the Wrists|"Mean arc of wrist flexion and extension six months after surgery.
Normal/expected range of motion for arc of wrist flexion and extension is approximately 160 degrees."|6 months|||Degrees||Standard Deviation|Mean
735673|NCT00438802|Primary|Maximum Tolerated Dose (MTD)|The Maximum Tolerated Dose (MTD) will be defined as the highest safely-tolerated dose where at most one out of six patients experiences a Dose Limiting Toxicity (DLT) with the next higher dose level having at least 2 patients who have experienced DLT. The MTD determination will be based on DLT toxicities encountered during the first 8 weeks of treatment reported in Primary Outcome Measure #1.|8 weeks from registration|Two patients from Dose level 2 were not able to complete cycle 1 and were not evaluated for dose limiting toxicity.||mg/kg Alefacept|||Number
735674|NCT00438802|Secondary|Clinical Response|"Treatment response and evaluation will be performed using standardized lymphoma International Working Group recommendations. >
> A Complete Response (CR) requires: >
Complete disappearance of all detectable clinical and radiographic evidence of > disease. >
All lymph nodes and nodal masses must have regressed to normal size. >
Partial Response (PR): >
greater than 50% decrease in Sum of Product Dimensions of the six largest dominant nodes, nodal masses, or skin lesions. >
No increase in size of other nodes >
no new sites of disease."|up to 12 cycles (28 days per cycle) of treatment.|Two patients from Dose level 2 were not able to complete cycle 1 and were not evaluated for dose limiting toxicity.||participants|||Number
735675|NCT00438802|Primary|Dose Limiting Toxicity (DLT)|"The Maximum Tolerated Dose (MTD) will be defined as the highest safely-tolerated dose where at most one out of six patients experiences a Dose Limiting Toxicity (DLT) with the next higher dose level having at least 2 patients who have experienced DLT. The MTD determination will be based on toxicities encountered during the first 8 weeks of treatment. >
> For this protocol, dose-limiting toxicity (DLT) will be defined as an adverse event attributed (definitely, probably, or possibly) to the study treatment and meeting the following criteria: >
grade 4 toxicity for neutrophils (<0.5 x 109/L) or platelets (<25 x 109/L) >
any grade 3 or higher solid organ toxicity not explainable by another obvious cause. >
more than 10 x ULN AST toxicity for more than 14 days >
any grade 4 infection. >
The number of patients who reported a dose limiting toxicity is reported here."|8 weeks from registration|Two patients from Dose level 2 were not able to complete cycle 1 and were not evaluated for dose limiting toxicity.||Participants|||Count of Participants
735676|NCT00438815|Primary|Percent of HAE Attacks With Substantial Relief of the Defining Symptom|Subjects were to assess their symptoms every 15 minutes up to 4 hours after the initial dose or until substantial relief of the defining symptom was achieved. The conservative analysis defined substantial relief as 3 consecutive assessments of improvement of the defining symptom; any attack that did not have 3 consecutive documented reports of improvement was considered a treatment failure. In the less conservative analysis, attacks also were considered to have responded if clinical improvement of the defining symptom occurred but data were incomplete due to cessation of symptom assessments.|Within 4 hours after initial treatment|ITT-E Population (N=101; the number of subjects who received at least one dose of C1INH-nf for the treatment of an acute HAE attack).||percent of attacks|||Number
735677|NCT00438815|Secondary|Complement C4 Serum Levels|Change in complement C4 serum levels from pre-infusion to 1 hour after the initial dose of study drug.|Pre-infusion to 1 hour post-infusion|ITT-E subjects with data at both sampling time points (N=74).||mg/dL||Standard Deviation|Mean
735678|NCT00438815|Secondary|Functional C1INH Serum Levels|"Percent change in functional C1INH serum levels from pre-infusion to 1 hour after the initial dose of study drug.
Functional C1INH serum levels are expressed as a percent of total detectable C1INH (ie, functional C1INH/total detectable C1INH)."|Pre-infusion to 1 hour post-infusion|ITT-E subjects with data at both sampling time points (N=82).||percent of functional C1INH||Standard Deviation|Mean
735679|NCT00438815|Secondary|Antigenic C1 Inhibitor (C1INH) Serum Levels|Change in antigenic C1INH serum levels from pre-infusion to 1 hour after the initial dose of study drug.|Pre-infusion to 1 hour post-infusion|ITT-E subjects with data at both sampling time points (N=84).||mg/dL||Standard Deviation|Mean
735680|NCT00438815|Secondary|Time to Beginning of Substantial Relief of the Defining Symptom for Subjects Who Received Multiple Treatments|For attack number 1, the number of censored observations precluded estimation of the 95% confidence interval (CI) upper bound for median time to event (subjects who did not experience beginning of substantial relief of the defining symptom within 4 hours after initial treatment were included in the analysis as censored observations). Entry of 4.0 hours indicates that data were not estimable (NE); as non-numeric data are not supported by the 95% CI field, entry of the actual result (ie, NE or >4.0) was not possible.|Within 4 hours after initial treatment|ITT-E subjects with at least 10 HAE attacks during the study (N=15).||hours||95% Confidence Interval|Median
735681|NCT00438815|Secondary|Time to Beginning of Substantial Relief of the Defining Symptom|Subjects were to assess their symptoms every 15 minutes up to 4 hours after the initial dose or until substantial relief of the defining symptom was achieved. Substantial relief was defined as 3 consecutive assessments of improvement of the defining symptom. Beginning of substantial relief was considered the first of the 3 consecutive assessments.|Within 4 hours after initial treatment|ITT-E Population.||hours||95% Confidence Interval|Median
735682|NCT00438815|Primary|Number of Hereditary Angioedema (HAE) Attacks Treated With C1INH-nf||Duration of the study (2.5 years)|Intent-to-treat Efficacy (ITT-E) Population (N=101; the number of subjects who received at least one dose of C1INH-nf for the treatment of an acute HAE attack).||attacks|||Number
735683|NCT00438854|Secondary|and to Correlate LYN Kinase Activity With Response in Study Subjects.||2 years||||||
735684|NCT00438854|Secondary|to Define the Spectrum of Toxicities of This Treatment in This Patient Population||2 years||||||
735685|NCT00438854|Secondary|to Determine the Progression-free Survival and Overall Survival||TBD||||||
735686|NCT00438854|Secondary|Duration of Overall Response for All Patients||TBD||||||
735687|NCT00438854|Secondary|The Complete Response Rate Will Also be Evaluated||TBD||||||
735688|NCT00438854|Primary|Overall Objective Response Rate in Terms of Complete Response, Nodular Partial Response, and Partial Response to Treatment With Dasatinib for Patients With CLL/SLL (Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma).||2 years|||participants who responded|||Number
735690|NCT00438880|Secondary|Progression-free Survival|The Progression-free survival (PFS) is defined as the time from registration to progression or death due to any cause. The distribution of PFS will be estimated using the method of Kaplan-Meier.|Up to 1 year from treatment start date|Only participants accrued to the Phase II portion of the study were evaluated for this endpoint.||months||95% Confidence Interval|Median
735691|NCT00438880|Primary|Tumor Response|"Complete Response (CR):
No measurable or nonmeasurable disease.
No symptoms of Lymphoma.
Non-palpable spleen, if palpable at baseline.
Histologically negative bone marrow, if positive at baseline.
All nodes <1.5 cm in transverse diameter.
Partial Response (PR):
greater than 50% decrease from baseline in the sum of the products of the longest perpendicular diameters of the six largest dominant lesions.
No new lesions
We are reporting the number of participants that attained a status of CR or PR."|Evaluations occur every three months up to a year|Participants accrued to the Phase I portion of this study were not used to analyze the Phase II primary endpoint.||participants|||Number
735692|NCT00438880|Primary|Maximum Tolerated Dose of CpG 7909 as Determined Using the Number of Participants With a DLT at Each Dose Level|"Participants will be treated in cohorts of 6 patients at each dose level of CpG 7909 (0.08 mg/kg, 0.16 mg/kg, 0.32 mg/kg, 0.48 mg/kg) and observed for at least 10 weeks post treatment. If at most one of the 6 patients experiences a dose limiting toxicity (DLT), a new cohort of 6 patients will be treated at the next higher dose level. A DLT for this study is defined as patients with one of the following:
Absolute neutrophil counts or platelet counts below 10*10^9/L for 14 days
Absolute neutrophil counts greater than 0.5 or less than 1*10^9/L
Platelet counts greater than 10 or less than 50*10^9/L for 28 days.
Any grade 3 non-hematologic toxicity not explainable by another obvious cause as assessed using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0.
We are reporting the number of DLTs at each of the dose levels. The maximum tolerated dose will be 0.48 mg/kg or the largest dose level where 1 or fewer participants reports a dose limiting toxicity."|at least 10 weeks post treatment up to 3 months.|Only participants accrued to the Phase I portion of this study were used to determine the maximum tolerated dose.||participants|||Number
735693|NCT00438932|Secondary|24-hour Urinary Phosphate|from 24-hr urine collections|2 weeks|||mg||Standard Error|Mean
735694|NCT00438932|Primary|Fibroblast Growth Factor 23 (FGF-23)|Plasma FGF-23 was measured using c-terminal FGF23 assay.|2 weeks|||RU/ml||Standard Error|Mean
735695|NCT00438971|Other Pre-specified|Longitudinal Interval Follow-up Evaluation Range of Impaired Functioning Tool (LIFE-RIFT)|The LIFE-RIFT is a brief measure of psychosocial functioning in work, interpersonal relations, satisfaction, and recreation. Scores on the LIFE-RIFT can range from 4, indicating very good functioning (no impairment) in all of the 4 component areas, to 20, indicating very poor functioning (severe impairment) in all of the 4 areas.|8 weeks|||units on a scale||Standard Deviation|Mean
735696|NCT00438971|Other Pre-specified|Sheehan Disability Scale (SDS)|The SDS is a 3-item measure with each item rated on a 10-point scale. The SDS measures the extent to which work/school, social life, and home life or family responsibilities are impaired by symptoms. Total scores range from 0 to 30, with higher scores reflecting greater impairment.|8 weeks|||units on a scale||Standard Deviation|Mean
735697|NCT00438971|Other Pre-specified|Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)|The Q-LES-Q is a self-report measure of the degree of enjoyment and satisfaction experienced by subjects in various areas of daily functioning. Only the first 14 items are included in scoring, which ranges from 14 to 70, with higher scores reflecting greater enjoyment and satisfaction. The last two items are not included in the total score but are standalone items.|8 weeks|||units on a scale||Standard Deviation|Mean
735698|NCT00438971|Other Pre-specified|Beck Anxiety Inventory (BAI)|The BAI is a 21-item self-report measure of anxiety with a focus on somatic symptoms. Total scores range from 0 to 63, with higher scores reflecting greater symptom severity.|8 weeks|||units on a scale||Standard Deviation|Mean
735699|NCT00438971|Other Pre-specified|Montgomery Asberg Depression Rating Scale (MADRS)|The MADRS is a 10-item clinician rating of depressive symptoms. Scores range from 0 to 60, with higher scores reflecting greater symptom severity.|8 weeks|||units on a scale||Standard Deviation|Mean
735700|NCT00438971|Secondary|Panic Attack Scale (PAS)|The PAS is a measure that assesses participants' total number of panic attacks (situational and unexpected with full and limited symptoms), as well as anticipatory anxiety, since last visit. There is no total score.|8 weeks|||units on a scale||Standard Deviation|Mean
735701|NCT00438971|Secondary|Clinical Global Impression of Severity Scale (CGI-S)|The CGI-S is a clinician-rated instrument used to assess global severity of symptoms. The CGI-S ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill). Remission was defined strictly as a CGI-S score of 1 or 2 (not at all ill or borderline ill) and zero panic attacks at endpoint.|8 weeks|||units on a scale||Standard Deviation|Mean
735702|NCT00438971|Primary|Panic Disorder Severity Scale (PDSS)|The PDSS contains seven items assessing multiple dimensions of panic disorder severity, including (a) frequency of panic attacks, (b) distress during panic attacks, (c) anticipatory anxiety, (d) agoraphobic fear and avoidance, (e) interoceptive fear and avoidance, (f) impairment of work functioning, and (g) impairment of social functioning. The PDSS ranges from 0 to 28, with higher ratings reflecting greater degrees of symptom severity.|8 weeks|||units on a scale||Standard Deviation|Mean
735703|NCT00439140|Other Pre-specified|Number of Participants With at Least a 20% Decrease From Baseline in FVC|Spirometry was conducted according to American Thoracic Society standards. A spirometer was used to measure FVC, the maximum amount of air exhaled from the lungs after taking the deepest breath possible at Baseline, Weeks 2, 6 and 12.|Baseline, Weeks 2, 6 and 12|Safety population included all randomized participants who received treatment.||Participants|||Number
735704|NCT00439140|Other Pre-specified|Number of Participants With at Least a 15% Decrease From Baseline in FVC|Spirometry was conducted according to American Thoracic Society standards. A spirometer was used to measure FVC, the maximum amount of air exhaled from the lungs after taking the deepest breath possible at Baseline, Weeks 2, 6 and 12.|Baseline, Weeks 2, 6 and 12|Safety population included all randomized participants who received treatment.||Participants|||Number
735705|NCT00439140|Secondary|Change From Baseline in Maximum Cystometric Capacity (MCC)|MCC (the maximum amount of urine the bladder could hold) was measured using urodynamic testing. The amount of urine collected was subtracted from the total volume infused measured as milliliters (mL) of urine. A positive change from Baseline indicated improvement (fuller bladder/ less incontinence).|Baseline, Week 6|Intent-to-treat population included all randomized participants.||mL||Standard Deviation|Mean
735706|NCT00439140|Secondary|Change From Baseline in the Maximum (Amplitude) Detrusor Pressure (MDP)|MDP was measured at the first involuntary detrusor contraction using urodynamic testing. A catheter was inserted into the bladder at Baseline and Week 6 and the pressure [measured in centimeters water (cm H20)] was determined as the bladder filled. A negative change from Baseline indicated improvement (less Detrusor pressure).|Baseline, Week 6|Intent-to-treat population included all randomized participants.||cm H2O||Standard Deviation|Mean
735707|NCT00439140|Secondary|Change From Baseline in the Number of Urinary Incontinence Episodes|The number of urinary incontinence episodes or leakage occurring over the previous 3 days was recorded in the patient bladder diary at Baseline and prior to Week 6. A negative change from Baseline indicated improvement (less incontinence/leakage).|Baseline, Week 6|Participants from the Intent-to-treat population (all randomized participants) using observed data for analysis.||Episodes||Standard Deviation|Mean
735708|NCT00439140|Primary|Change From Baseline in FEV1/FVC Ratio|The FEV1/FVC ratio was calculated by dividing the FEV1 value by the FVC value representing the portion (or ratio) of FVC exhaled in one second. A positive change from Baseline indicated improvement.|Baseline, Week 6|Safety population included all randomized participants who received treatment.||Ratio||Standard Deviation|Mean
735709|NCT00439140|Primary|Change From Baseline in Forced Expiratory Volume in One Second (FEV1)|Spirometry was conducted according to American Thoracic Society standards. A spirometer was used to measure FEV1, the maximum amount of air exhaled in one second, at Baseline and Week 6. The highest value at each time-point was recorded. A positive change from Baseline indicated improvement.|Baseline, Week 6|Safety population included all randomized participants who received treatment.||Liters||Standard Deviation|Mean
735710|NCT00439140|Primary|Change From Baseline in Forced Vital Capacity (FVC)|Spirometry was conducted according to American Thoracic Society standards. A spirometer was used to measure FVC, the maximum amount of air exhaled from the lungs after taking the deepest breath possible, at Baseline and Week 6. A positive change from Baseline indicated improvement.|Baseline, Week 6|Safety Population included all randomized participants who received treatment.||Liters||Standard Deviation|Mean
735711|NCT00439179|Secondary|Number of Patients Who Experienced a Partial Response|To assess clinical activity of GW572016 with gemcitabine and with the combination of gemcitabine and oxaliplatin in patients with advanced pancreaticobiliary cancers.|every two months until progression|||participants|||Number
735712|NCT00439179|Primary|Toxicity (Number of Patients Who Experiened DLTs)|To determine the safety and tolerability of GW572016 when administered with gemcitabine and the combination of gemcitabine and oxaliplatin in patients with advanced pancreaticobiliary cancers. Numbers below are DLTs|until death, approximately 2 years|||participants|||Number
735713|NCT00439218|Secondary|Overall Study Drug Compliance|Subjects receiveing 80% or more of the prescribed doses within each study visit interval were considered compliant.|12 weeks|A total of 5 participants were enrolled in the study. Four enrolled in Cohort 1.||Participants|||Number
735714|NCT00439218|Secondary|Pharmacokinetic Parameters (Area Under the Plasma Concentration Versus Time Curve (AUC))|Area under the plasma concentration versus time curve (AUC)|12 weeks|||µmol/L * hours||Standard Deviation|Mean
735715|NCT00439218|Secondary|Pharmacokinetic Parameters (Time to Maximum Plasma Concentration)|Time to maximum plasma concentration (Tmax)|12 weeks|The study was closed prematurely due to slow accrual. These data have not yet been analyzed. Their interpretability will be limited because of the small number of specimens collected.||Hours||Standard Deviation|Mean
735716|NCT00439218|Secondary|Pharmacokinetic Parameters (Maximum Plasma Concentration)|Maximum Plasma Concentration (Cmax)|12 weeks|||µM||Standard Deviation|Mean
735717|NCT00439218|Primary|Survival Motor Neuron (SMN) Protein|The change of level in blood SMN protein from baseline to assess time course and dose response.|Baseline - 12 Weeks|The study was closed prematurely due to slow accrual. These data are exploratory and have not yet been analyzed. Their interpretability will be limited because of the small number of specimens collected.||SMN/beta tubulin||Standard Deviation|Mean
735718|NCT00439218|Secondary|Drug Safety|Adverse event (AE) monitoring|14 weeks|The study was closed prematurely due to slow accrual. These data have not yet been analyzed. Their interpretability will be limited because of the small number of subjects enrolled. There were no safety concerns reported by the SMC.||Adverse Events|||Number
735719|NCT00439218|Primary|Survival Motor Neuron (SMN) Messenger Ribonucleic Acid (mRNA)|The change of level in blood SMN mRNA from baseline to assess time course and dose response.|Baseline - 12 weeks|The study was closed prematurely due to slow accrual. These data are exploratory and have not yet been analyzed. Their interpretability will be limited because of the small number of specimens collected.||Cycle Threshold (Ct)||Standard Error|Mean
735720|NCT00439218|Primary|Dose Limiting Toxicities (DLT)|Number of DLTs to determine the maximum tolerated dosage. A DLT is defined as any Grade(GR)3 or higher adverse event, GR 1 or higher cardiac arrhythmia; GR 2 or higher vomiting; GR 2 or higher liver dysfunction/failure (clinical); GR 2 elevation of amylase or lipase accompanied by clinical symptoms of pancreatitis. The following GR 2 events are classified as DLTs if evaluated to be clinically significant by the principal investigator or medical safety monitor: decrease of hemoglobin, WBCs, platelets; elevation of AST, ALT, bilirubin; abnormlity of Na, K, Cl, CA, HCO3, glucose, BUN, creatinine.|29 days|The study was closed prematurely due to slow accrual. The MTD could not be determined due to the small number of subjects enrolled.||DLT(s)|||Number
735721|NCT00439231|Primary|To Establish the Overall Response Rate Measured at 24 Weeks After First Dose of Lenalidomide Using This Dosing Regimen|To establish the overall response rate based on peripheral blood measures (absolute neutrophil count, platelets, and/or hemoglobin), lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; and bone marrow biopsy measured at 24 weeks after first dose of lenalidomide using this dosing regimen|24 weeks of lenalidomide therapy|||participants|||Number
735722|NCT00439244|Secondary|Bone Resorption and Formation Biochemical Markers : Beta C-terminal Telopeptides of Type I Collagen (β-CTx)|Specialized tests for markers of bone formation such as β-CTx were performed at Baseline, and Weeks 4, 8, 26, 39, and 52. The amount of serum β-CTx was determined by the central laboratory.|At Baseline, Week 4, Week 8, Week 26, Week 39 and Week 52|The intent-to-treat (ITT) population consisted of all randomized patients with available data. n = ITT patients with a measurement at each visit, as determined by the efficacy visit window||ng/mL||Standard Deviation|Mean
738829|NCT00463580|Secondary|CRP, IL-6, TNF-alpha, TNFR 1 and 2|Investigate the effects of baseline CRP (and IL-6, TNF-alpha, TNFR 1 and 2) on reduction in depressive symptoms in patients in the two treatment groups.|Baseline||||||
735723|NCT00439244|Secondary|Bone Resorption and Formation Biochemical Markers : N-terminal Propeptide of Type I Collagen (P1NP)|Specialized tests for markers of bone formation such as n-terminal propeptide of type I collagen (P1NP) were performed at Baseline, and Weeks 4, 8, 26, 39, and 52. The amount of serum P1NP was determined by the central laboratory.|At Baseline, Week 4, Week 8, Week 26, Week 39 and Week 52|The intent-to-treat (ITT) population consisted of all randomized patients with available data. n = ITT patients with a measurement at each visit, as determined by the efficacy visit window||ng/mL||Standard Deviation|Mean
735724|NCT00439244|Secondary|Percent Change From Baseline in Total Hip Bone Mineral Density (BMD) at Week 13, Week 26 and Week 52|BMD measurements of the total hip by Dual X-ray absorptiometry (DXA) were performed on all patients at screening, and Weeks 13, 26, and 52 (or early termination). Every attempt was made to obtain the BMD measurements at the scheduled visit. If this was not possible, a BMD measurement ± 7 days from the scheduled visit was obtained. For the final DXA at Week 52, the window was 10 - 15 days prior to the final study visit. BMD scans were acquired locally and all results sent to a central reader for evaluation.|Baseline through Week 13, Week 26 and Week 52|The intent-to-treat (ITT) population consisted of all randomized patients with available data. ITT patients with evaluable measurements at both baseline and post-baseline within each efficacy visit window were analyzed.||Percent Change||Standard Error|Least Squares Mean
735725|NCT00439244|Secondary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 13 and Week 26|BMD measurements of the lumbar spine (L1-L4) by Dual X-ray absorptiometry (DXA) were performed on all patients at screening, and Weeks 13, 26, and 52 (or early termination). Every attempt was made to obtain the BMD measurements at the scheduled visit. If this was not possible, a BMD measurement ± 7 days from the scheduled visit was obtained. For the Final DXA at Week 52, the window was 10 - 15 days prior to the final study visit. BMD scans were acquired locally and all results sent to a central reader for evaluation.|Baseline through Week 13 and Week 26|The intent-to-treat (ITT) population consisted of all randomized patients with available data. ITT patients with evaluable measurements at both baseline and post-baseline within each efficacy visit window were analyzed.||Percent Change||Standard Error|Least Squares Mean
735726|NCT00439244|Primary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 52|BMD measurements of the lumbar spine (L1-L4) by Dual X-ray absorptiometry (DXA) were performed on all patients at screening, and Weeks 13, 26, and 52 (or early termination). Every attempt was made to obtain the BMD measurements at the scheduled visit. If this was not possible, a BMD measurement ± 7 days from the scheduled visit was obtained. For the Final DXA at Week 52, the window was 10 - 15 days prior to the final study visit. BMD scans were acquired locally and all results sent to a central reader for evaluation.|Baseline through Week 52|The intent-to-treat (ITT) population consisted of all randomized patients with available data.||Percent change||Standard Error|Least Squares Mean
735727|NCT00439270|Secondary|Number of Participants Meeting the Criteria for On-study Abnormal Results Grade 3-4 of Clinical Laboratory Tests|ULN=upper limit of normal. Graded by Common Toxicity Criteria: 1 (least severe) to 4 (life threatening ). Absolute neutrophil count (*10^9/L), Grade 3, <1.0-0.5; Grade 4, <0.5. Hemoglobin (mmol/L), Grade 3, <4.9-4.0; Grade 4, <4.0. Platelets (*10^9/L), Grade 3, <50.0-25.0; Grade 4, <25.0. Leukocytes (*10^9/L) Grade 3, <2.0-1.0; Grade 4, <1.0. ALP, ALT, and AST (*ULN), Grade 3, >5.0-20.0; Grade 4, >20.0. Total bilirubin (*ULN), Grade 3, >3.0-10.0; Grade 4, >10.0. Creatinine (*ULN), Grade 3, >3.0-6.0; Grade 4, >6.0. Hypercalcemia (mmol/L), Grade 3, >3.1-3.4; Grade 4, >3.4. Hypocalcemia mmol/L), Grade 3, <1.75-1.5; Grade 4, <1.5. Hyperkalemia (mmol/L), Grade 3, >6.0-7.0; Grade 4, >7.0. Hypokalemia (mmol/L), Grade 3, <3.0-2.5; Grade 4, <2.5. Hypernatremia (mmol/L), Grade 3, >155-160; Grade 4, >160. Hyponatremia (mmol/L), Grade 3, <130-120; Grade 4, <120. Phosphorus (mmol/L), Grade 3, <0.6-0.3; Grade 4, <0.3. Prothrombin time (seconds), Grade 3, >2.0; Grade 4, not defined.|From Day 2 of Cycle 1 to up to 30 days after last dose of study drug (up to approximately 49 months)|All participants who received at least 1 dose of study drug||Participants|||Number
735728|NCT00439270|Secondary|Area Under the Concentration-time Curve (AUC) From Time 0 to Infinity (AUC[Inf]) of Docetaxel||Cycle 1, Day 1 at 0, 0.5, 1, 1.25, 1.5, 2, 3, 4, 7, 10, 24, and 48 hours postdose|All patients who received at least 1 dose of dasatinib||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
735729|NCT00439270|Secondary|Maximum Observed Plasma Concentration (Cmax) of Dasatinib and of Docetaxel||Docetaxel: Cycle 1, Day 1 at 0, 0.5, 1, 1.25, 1.5, 2, 3, 4, 7, 10, 24, and 48 hours postdose; dasatanib: Cycle 1, Day 14 at 0, .5, 1, 2, 3, 4, 7, 10, and 24 hours postdose|All patients who received at least 1 dose of dasatinib; n=number of patients who were evaluable||ng/mL||Geometric Coefficient of Variation|Geometric Mean
735730|NCT00439270|Secondary|Area Under the Concentration-time Curve (AUC) From 0 to 10 Hours Postdose (AUC [0-10])and AUC in 1 Dosing Interval, From Time 0 to 24 Hours (AUC[Tau])of Dasatinib Coadministered With Docetaxel||Cycle 1, Day 14 at 0, 0.5 , 1, 2, 3, 4, 7, 10, and 24 hours postdose|All patients who received at least 1 dose of dasatinib; n=number of patients who were evaluable||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
735731|NCT00439270|Secondary|Number of Participants With Death as Outcome, Drug-related Serious Adverse Events (SAEs), Drug-related Adverse Events (AEs), Drug-related AEs Leading to Discontinuation, and Drug-related Grade 3 or 4 AEs in the Phase 2 Cohort|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=having certain, probable, possible, or missing relationship to study drug. Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Leading to death.|From first dose Day 1 through at least 30 days after last dose of either dasatinib or docetaxel, whichever was later (up to approximately 49 months)|All patients who received dasatinib, 100 mg + docetaxel, 75 mg/m^2||Participants|||Number
735753|NCT00439335|Secondary|Number of Participants Achieving a 4-fold or Greater Increase in HAI Antibody Titers 7 Months After Dose 1.|Number of participants achieving a 4-fold or greater increase in HAI antibody titers against influenza A/H5N1 virus in each vaccine group seven months after receipt of the first dose of vaccine.|Approximately Day 208|||Participants|||Number
735754|NCT00439335|Secondary|Number of Participants Achieving a Serum HAI Titer of Greater Than or Equal to 40 After Dose 1.|Number of participants achieving a serum HAI titer of greater than or equal to 40 against influenza A/H5N1 virus in each vaccine group one month after receipt of the first dose of vaccine.|Approximately Day 28|||Participants|||Number
735732|NCT00439270|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Drug-related Adverse Events (AEs), Drug-related AEs Leading to Discontinuation, and Drug-related Grade 3 or 4 AEs in the Overall Population|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=having certain, probable, possible, or missing relationship to study drug. Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Leading to death.|From first dose Day 1 through at least 30 days after last dose of either dasatinib or docetaxel, whichever was later (up to approximately 49 months)|All participants who received at least 1 dose of dasatinib||Participants|||Number
735733|NCT00439270|Secondary|Baseline Scores and Changes in Pain Intensity From Baseline on the Brief Pain Inventory Short Form (BPI-sf) Scores Through Cycle 6|The BPI-sf assessed intensity of pain in the last 24 hours as well as impact of pain on daily functions. Patients rated the severity of their pain at its worst, least, and average in the last 24 hours using an 11-point rating scale with endpoints of no pain (0 points) and pain as bad as you can imagine (11 points). They were asked to rate their present pain and pain at the time they completed the BPI-sf. Using an 11-point rating scale with endpoints of does not interfere (0 points) and completely interferes (11 points), the BPI-sf similarly assessed to what extent pain interfered with mood, walking, general activity, work, relations with others, sleep, and enjoyment of life. The BPI-sf also asked patients to mark the location of their pain on a body drawing and included other questions about pain treatment and the extent of pain relief. The BPI-sf was collected in the Phase 2 portion of the study only. For on-treatment visits, the BPI-sf was completed prior to the docetaxel infusion.|At pretreatment visit and on Day 1 of Cycles 2 through 6, then Day 1 of every other cycle, at end of treatment, and at follow-up visit|All patients who received dasatinib, 100 mg + docetaxel, 75 mg/m^2, in the Phase 2 portion of the study and completed the BPI-sf at baseline. n=evaluable participants in that cycle.||Units on a scale||Full Range|Median
735734|NCT00439270|Secondary|Percentage of Participants With Improvement on Bone Scan|Improvement=disappearance of at least 1 lesion, no new lesions appearing since the most recent prior assessment, and new pain not developing in an area that was previously visualized|From Day 1 of therapy to last bone scan assessment (up to 51.6 months)|All patients who received dasatinib, 100 mg + docetaxel, 75 mg/m^2||Percentage of participants||95% Confidence Interval|Number
735735|NCT00439270|Secondary|Number of Participants by Best On-study Bone Scan Assessment From Baseline|Stable=no new lesions appeared at any 6-week assessment or new pain was not developed in an area that was previously visualized for a minimum of 18 weeks; no change=stable disease prior to 18 weeks and then discontinued treatment; progression=2 or more new areas of focal uptake or new adverse clinical symptoms in an area previously visualized; improved=disappearance of at least 1 lesion, no new lesions appearing since the most recent prior assessment, and new pain not developing in an area that was previously visualized.|From Day 1 of therapy to last bone scan assessment (up to 51.6 months)|All patients who received dasatinib, 100 mg + docetaxel, 75 mg/m^2||Participants|||Number
735736|NCT00439270|Primary|Recommended Phase 2 Dose of Dasatinib Administered With Docetaxel, 75 mg/m^2|Because no dose-limiting toxicities occurred, the recommended dose of dasatinib used in Phase 2 was based on findings from ongoing studies in chronic myelogenous leukemia and experience from the previous Phase 2 study of single-agent dasatinib in chronic refractory prostate cancer. The recommended Phase 2 dose of docetaxel (75 mg/m^2) was based on the docetaxel package insert.|From Day 3 of first 21-day cycle to Cycle 2 , Day 21 (or Study Day 42)|All patients who received at least 1 dose of dasatinib in Phase 1||mg|||Number
735737|NCT00439270|Secondary|Number of Participants by Best On-study Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST)|"RECIST for target lesions: Complete Response (CR)=disappearance of clinical and radiologic evidence of target lesions. Partial Response (PR)=a 30% or greater decrease in the sum of the longest diameter (LD) of all lesions in reference to the baseline sum LD. Stable disease (SD)=neither sufficient increase to qualify for Progressive Disease (PD) nor sufficient shrinkage to qualify for PR.
PD=a 20% or greater increase in the sum of LD of all target lesions, taking as reference the smallest sum LD recorded at or following baseline; unequivocal progression of nonmeasurable disease/lesions as evaluated by CT scan or MRI (not as evaluated by radionuclide bone scan) and/or new lesions are present.
To qualify as SD, patients had to exhibit SD for a minimum of 18 weeks. Those with evaluations noted as SD prior to 18 weeks and discontinued were reported as no change."|Pretreatment visit then every 6 weeks thereafter (up to 51.6 months)|All patients who received dasatinib, 100 mg + docetaxel, 75 mg/m^2||Participants|||Number
735738|NCT00439270|Secondary|Percentage of Participants With an Objective Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST)|Objective response rate is defined as the percentage of participants who have achieved best responses of confirmed Complete Response (CR) or Partial Response (PR) where confirmed requires repeat evaluations for a minimum of 4 weeks after the criteria for response are first met. RECIST: CR=disappearance of clinical and radiologic evidence of target lesions; PR=a 30% or greater decrease in the sum of the longest diameter (LD) of all lesions in reference to the baseline sum LD.|Pretreatment visit then every 6 weeks thereafter (up to 51.6 months)|All patients who received dasatinib, 100 mg + docetaxel, 75 mg/m^2||Percentage of participants||95% Confidence Interval|Number
735739|NCT00439270|Secondary|Number of Months of Progression-free Survival (PFS)|"PFS defined as time in months from the first dosing date to the date of disease progression or the date of death. Patients who neither progressed nor died were censored on the date of their last on-study prostate specific antigen (PSA) measurement, tumor assessment, or radionuclide bone scan assessment (whichever occurred last). Disease progression defined as either of the following: progression on radionuclide bone scan, death, or at least 2 of the following:
tumor progression, as defined by modified Response Evaluation Criteria in Solid Tumors; PSA progression; or investigator-defined clinical progression based on physical examination, history, symptoms, and performance status."|Patients with an event: time from first dose to disease progression or death, whichever occurs first. Patients without an event: time to last on-study PSA measurement, tumor assessment, or radionuclide bone scan assessment, whichever occurs last|All patients who received dasatinib, 100 mg + docetaxel, 75 mg/m^2||Months||95% Confidence Interval|Median
735740|NCT00439270|Secondary|Duration of Prostate Specific Antigen (PSA) Response|Duration of response is computed for participants with confirmed PSA response. It is measured in months from the time of the first of 2 consecutive measurements meeting the criteria for confirmed PSA response to the date of the first of 3 consecutive measurements that confirm PSA progression, the date of disease progression, or the date of death. Participants who neither progressed (PSA or disease) nor died were censored on the date of their last PSA assessment. PSA response is defined as a decrease of >=50% in PSA levels from baseline, sustained for at least 6 weeks and confirmed by at least 2 measurements. PSA progression is defined as 3 consecutive increases in PSA from baseline or nadir, each measurement at least 1 week apart. The final confirming PSA measurement had to be ≥5ng/mL higher than baseline or nadir and also represent at least a 50% increase from baseline or nadir (ie, the value is ≥1.5*baseline or nadir PSA).|At pretreatment visit, and on Day 1 of Cycles 2 through 12, then every other cycle, where investigator deems appropriate, and at end of treatment|All participants who received dasatinib, 100 mg + docetaxel, 75 mg/m^2 and who had a PSA response||Months||95% Confidence Interval|Median
735741|NCT00439270|Primary|Maximum Tolerated Dose (MTD) of Dasatinib Administered With Docetaxel|MTD was defined by dose-limiting toxicity (DLT) criteria. DLT was defined as grade 4 neutropenia causing treatment interruption for >14 days, febrile neutropenia, grade 4 thrombocytopenia, grade 3 thrombocytopenia with a bleeding episode requiring platelet transfusion, nausea and/or vomiting despite medical intervention/prophylaxis causing treatment interruption for >14 days, grade 3-4 asthenia/fatigue, any other grade >=3 nonhematologic toxicity except alopecia or transient arthralgia/myalgia (unless unresponsive to intervention), or interruption of study drug for >14 days due to toxicity. When defined, the MTD would serve as recommended Phase 2 dose of each drug in the combination of oral dasatinib and intravenous docetaxel.|From Day 3 of first 21-day cycle to Cycle 2 , Day 21 (or Study Day 42)|All patients who received at least 1 dose of dasatinib in Phase 1||mg|||Number
735742|NCT00439270|Secondary|Percentage of Participants With a Prostate Specific Antigen (PSA) Response|PSA response rate is defined as a decrease of >=50% in PSA levels from baseline, sustained for at least 6 weeks and confirmed by at least 2 measurements|At pretreatment visit, and on Day 1 of Cycles 2 through 12, then every other cycle, where investigator deems appropriate, and at end of treatment (up to 51.6 months)|All patients who received dasatinib, 100 mg + docetaxel, 75 mg/m^2||Percentage of participants||95% Confidence Interval|Number
735743|NCT00439309|Secondary|Time to Wound Closure|Time to wound closure was defined as the elapsed time between initial clamp removal at the last anastomotic site until skin closure. This endpoint was analyzed using the log-rank test to compare the two treatment groups. The Kaplan-Meier method was used to obtain estimated median times to wound closure and the corresponding 95% confidence intervals for each treatment group.|From initial clamp removal at the last anastomotic site until skin closure|||Minutes||95% Confidence Interval|Median
735744|NCT00439309|Secondary|Time to Hemostasis|Time to hemostasis determined from time circulation restored after treatment application until bleeding stopped (assessed at intervals of immediate, 1, 3, 5, 7.5 and 10 min). For subject with two sites, time to hemostasis of both sites used for analysis. Subjects for whom bleeding had not stopped within 10 min considered censored observations.|Within 10 minutes post restoration of blood flow|||Minutes||95% Confidence Interval|Median
735745|NCT00439309|Secondary|Proportion of Overall Sealing Successes at Treated Anastomoses (Anastomoses Level)|A site with no suture line bleeding after blood flow is restored and monitored for a minimum period of 60 seconds to confirm cessation of blood flow.|Within 10 minutes post restoration of blood flow|||percentage of anastomitic sites|Anastomosis||Number
735746|NCT00439309|Secondary|Proportion of Immediate Sealing Success at Treated Anastomoses (Anastomoses Level)|A site with no suture line bleeding after blood flow is restored and monitored for a minimum period of 60 seconds to confirm cessation of blood flow|60 seconds post restoration of blood flow|||percentage of anastomotic sites|Anastomosis||Number
735747|NCT00439309|Primary|Sealing Success|The primary effectiveness endpoint is sealing success defined as complete anastomotic suture line sealing within 10 minutes following restoration of blood flow without use of an adjunctive hemostatic technique different from the assigned treatment. The primary effectiveness endpoint was evaluated on a per subject basis. For subjects with two treated sites, the subject is considered a success only if there is complete anastomotic suture line sealing within 10 minutes at both sites.|Within 10 minutes following restoration of blood flow|The primary effectiveness endpoint was evaluated on a per subject basis. For subjects with two treated sites, the subject is considered a success only if there is complete anastomotic suture line sealing within 10 minutes at both sites.||percentage of participants||95% Confidence Interval|Number
735748|NCT00439335|Primary|Occurrence of Solicited Local Symptoms During a 7-day Surveillance Period (Systematically Collected) Following Vaccinations at Days 0 and 28.|The number of participants reporting pain, tenderness, itching, induration, erythema, and pigmentation. Participants are counted only once for each symptom but may have experienced symptoms on multiple occasions.|7 days after each vaccination|||Participants|||Number
735749|NCT00439335|Primary|Occurrence of Solicited Systemic Symptoms During a 7-day Surveillance Period (Systematically Collected) Following Vaccinations at Days 0 and 28.|The number of participants reporting fever, feverishness, malaise, myalgia, headache and nausea. Participants are counted only once for each symptom but may have experienced symptoms on multiple occasions.|7 days after each vaccination|||Participants|||Number
735750|NCT00439335|Primary|Occurrence of Unsolicited Symptoms During a 28-day Surveillance Period Following Vaccinations at Days 0 and 28.|The number of participants spontaneously reporting any symptom (defined as any Adverse Event considered associated with the product) within 28 days of vaccination. Participants are counted only once but may have experienced events on multiple occasions.|Through approximately Day 56|||Participants|||Number
735751|NCT00439335|Secondary|Number of Participants Achieving a Serum HAI Titer of Greater Than or Equal to 40 at 7 Months After Dose 1.|Number of participants achieving a serum HAI titer of greater than or equal to 40 against influenza A/H5N1 virus in each vaccine group 7 months after receipt of the first dose of vaccine.|Approximately Day 208|||Participants|||Number
735752|NCT00439335|Secondary|HAI GMT at 7 Months After Dose 1|HAI GMT against influenza A/H5N1 virus in each vaccine group seven months after receipt of the first dose of vaccine.|Approximately Day 208|||Antibody Titer||95% Confidence Interval|Geometric Mean
735755|NCT00439335|Secondary|HAI GMT After Dose 1|HAI GMT against influenza A/H5N1 virus one month after receipt of the first dose of vaccine.|Approximately Day 28|||Antibody titer||95% Confidence Interval|Geometric Mean
735756|NCT00439335|Secondary|Number of Participants Achieving a 4-fold or Greater Increase in HAI Antibody Titers After Dose 1.|Number of participants achieving a 4-fold or greater increase in HAI antibody titers against influenza A/H5N1 virus in each vaccine group one month after receipt of the first dose.|Approximately Day 28|||Participants|||Number
735757|NCT00439335|Secondary|Number of Participants Achieving a HAI Titer of Greater Than or Equal to 40 After Dose 2|Number of participants achieving a serum HAI titer of greater than or equal to 40 against influenza A/H5N1 virus in each vaccine group 28 days after receipt of the second dose of vaccine|Approximately Day 56|||Participants|||Number
735758|NCT00439335|Secondary|HAI Geometric Mean Titer (GMT) After Dose 2|HAI geometric mean titer (GMT) against influenza A/H5N1 virus in each vaccine group 28 days after receipt of the second dose of vaccine.|Approximately Day 56.|||Antibody Titer||95% Confidence Interval|Geometric Mean
735759|NCT00439335|Primary|Number of Participants Spontaneously Reporting Any Serious Adverse Event.|Any untoward medical occurrence that resulted in death, persistent/significant disability/incapacity, required in-patient hospitalization or prolongation thereof, was life threatening or a congenital anomaly/birth defect in offspring of a study subject; or may have jeopardized the participant or required intervention to prevent one of the outcomes.|Through Day 208.|||Participants|||Number
735760|NCT00439335|Primary|Number of Participants Achieving a 4-fold or Greater Increase in HAI Antibody Titers After Dose 2|Number of participants in each vaccine group achieving a 4-fold or greater increase in serum hemagglutination inhibition (HAI) antibody titers against influenza A/H5N1 virus 28 days after receipt of the second dose of vaccine|Approximately Day 56.|||Participants|||Number
735761|NCT00439413|Secondary|Abstinence|The proportion is determined by dividing the number who achieved abstinence at the end of treatment as defined for the primary outcome measure and are still abstinent by self report and separately by self report with confirmation by exhaled CO by the total number randomized to the treatment group.|week 14|||participants|||Number
735762|NCT00439413|Primary|Quit Rate|The number of subjects in each treatment group who ceased smoking as measured by four weeks of self-reported abstinence confirmed by at least two exhales - carbon monoxide (CO) measurements during the last four weeks of treatment (study weeks 6 through 9).|Study weeks 6 through 9|||participants|||Number
735763|NCT00439517|Secondary|Safety - Number of Patients Experiencing Any Adverse Event|Please refer to Adverse Events section for details of individual serious adverse events and other adverse events|Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Feb 2007, until cut off date, 30 Jun 2009|Safety population||participants|||Number
735764|NCT00439517|Secondary|Treatment Impact on Social Daily Living and Health Care Resource Utilization|Non-protocol medical care visits and consultations|From randomisation until final visit, reported between day of first patient randomised, Feb 2007, until cut-off date, 30 Jun 2009|ITT population||visits or consultations|||Number
735765|NCT00439517|Secondary|QOL Therapy Preference Questionnaire (TPQ)|TPQ was used to investigate which features of chemotherapy treatment are the most relevant in ensuring patient satisfaction. The most essential characteristics of a cancer medication are shown at baseline and at cycle 3, along with percentage of subjects selecting that characteristic.|at baseline, at every first day of every third cycle during active - treatment, and at final tumor assessment , reported between day of first patient randomised, Feb 2007, until cut-off date, 30 Jun 2009. All cycles were 4 weeks long unless dosing delays|"Patients were considered evaluable for TPQ provided they had at least one evaluable TPQ questionnaire and they were also included in the ITT TPQ subset population.
The most essential characteristics of a cancer medication score are shown at baseline and cycle 3, no further cycles are available due to the low number of patients in later cycles"||percentage of participants|||Number
735766|NCT00439517|Secondary|QOL EuroQuol-5D (EQ-5D) Health Outcome Questionnaire|The EQ-5D questionnaire is a measure of health status that provides a simple descriptive profile and a single index value. The optional part of the questionnaire was not applied. The EQ-5D defines health in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 5 items are combined to generate health profiles. These profiles were converted to a continuous single index score using a one to one matching. The lowest possible score is -0.59 and the highest is 1.00, higher scores on the EQ-5D represent a better QOL.|at baseline, at every first day of every third cycle during active - treatment, and at final tumor assessment , reported between day of first patient randomised, Feb 2007, until cut-off date, 30 Jun 2009. All cycles were 4 weeks long unless dosing delays|Patients were considered evaluable for EQ-5D provided they had at least one evaluable EQ-5D questionnaire and provided that they were also included in the ITT Population.||scores on a scale||Standard Error|Least Squares Mean
735767|NCT00439517|Secondary|Quality of Life (QOL) Functional Assessment of Cancer Therapy-Colorectal (FACT-C)|All of the single-item measures of the FACT-C are assessed on ordinal response categories ranging from 0=”Not at all” to 4=”Very much”. For scoring purposes the response scores are reversed on negatively phrased questions. The principle for scoring the sub-scales is the same in all cases: subscale score = (Sum of items × Number of items in the subscale) / numbers of items answered. The lowest possible total score is 0 and the highest is 136. A high scale score represents a high QOL.|At baseline, at every first day of every third cycle during active - treatment, and at final tumor assessment , reported between day of first patient randomised, Feb 2007, until cut-off date, 30 Jun 2009. Cycles were 4 weeks long unless dosing delays|Patients were considered evaluable for FACT-C provided they had at least one evaluable FACT-C questionnaire and provided that they were also included in the ITT Population||scores on a scale||Standard Error|Least Squares Mean
735768|NCT00439517|Secondary|Overall Survival (OS)|Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.|Time from randomization to death or last known to be alive, reported between day of first patient randomised, Feb 2007, until cut off date, 31 Aug 2011|ITT population i.e. all randomized subjects.||months||95% Confidence Interval|Median
735769|NCT00439517|Secondary|Overall Survival (OS)|Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.|Time from randomization to death or last known to be alive, reported between day of first patient randomised, Feb 2007, until cut off date, 30 Jun 2009|ITT population i.e. all randomized subjects.||months||95% Confidence Interval|Median
735770|NCT00439517|Secondary|Best Overall Response (BOR)|"BOR defined as percentage of subjects, whose BOR was either (confirmed) complete response (CR) or partial response (PR), relative to the number of subjects belonging to the study population of interest. CR defined as Disappearance of all target lesions plus disappearance of all non-target lesions & without appearance of any new lesions; confirmed minimum 4 weeks later. PR defined as At least 30% reduction in the SOLD of target lesions plus no significant change in non-target lesions to qualify for either CR or PD without appearance of new lesions; confirmed minimum 4 weeks later"|Evaluations were performed every 8 weeks until disease progression, reported between day of first patient randomised, Feb 2007, until cut off date, 30 Jun 2009|ITT population i.e. all randomized subjects.||percentage of participants||95% Confidence Interval|Number
735771|NCT00439517|Primary|Progression-free Survival (PFS)|Duration from randomization until progression or death due to any cause. Only deaths within 12 weeks of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment. Response and progression were assessed by the Investigators using response evaluation criteria in solid tumors (RECIST) 1.0 criteria|Time from randomization to disease progression, death, or last tumor assessment reported between day of first patient randomised, Feb 2007, until cut off date, 30 Jun 2009|Intention-to-treat (ITT) population i.e. all randomized subjects .||months||95% Confidence Interval|Median
735772|NCT00439569|Secondary|Overall Study Drug Compliance|Subjects receiving 80% or more of the prescribed doses within each study visit interval were considered compliant.|12 Weeks|Four of the nine subjects enrolled were less than 80% compliant. The study was closed prematurely due to poor compliance with study drug administration.||Participants|||Number
735773|NCT00439569|Secondary|Pharmacokinetic Parameters (Area Under the Plasma Concentration Versus Time Curve (AUC))|Area Under the Plasma Concentration versus Time curve (AUC)|12 weeks|||µmol/L * hours||Standard Deviation|Mean
735774|NCT00439569|Primary|Survival Motor Neuron (SMN) Protein|The change of level in blood SMN protein from baseline to assess time course and dose response.|Baseline - 12 weeks|The study was closed prematurely due to poor compliance with study drug administration. These data have not yet been analyzed. Their interpretability will be limited because of the small number of specimens collected.||Change in SMN Protein level||Standard Deviation|Mean
735775|NCT00439569|Secondary|Pharmacokinetic Parameters (Time to Maximum Concentration)|Time to Maximum Concentration (Tmax)|12 weeks|||Hours||Standard Deviation|Mean
735776|NCT00439569|Secondary|Pharmacokinetic Parameters (Maximum Plasma Concentration)|Maximum Plasma Concentration (Cmax)|12 weeks|||µM||Standard Deviation|Mean
735777|NCT00439569|Secondary|Drug Safety|Adverse event(AE)monitoring|14 weeks|The study was closed prematurely due to poor compliance with study drug administration. These data have not yet been analyzed. Their interpretability will be limited because of the small number of subjects enrolled. There were no safety concerns reported by the study monitoring committee (SMC).||Adverse Events|||Number
735778|NCT00439569|Primary|Survival Motor Neuron (SMN) Messenger Ribonucleic Acid (mRNA)|The change of level in blood SMN mRNA from baseline to assess time course and dose response.|Baseline - 12 weeks|The study was closed prematurely due to poor compliance with study drug administration. These data have not yet been analyzed. Their interpretability will be limited because of the small number of specimens collected.||Change in mRNA level||Standard Error|Mean
735779|NCT00439569|Primary|Dose Limiting Toxicities (DLT)|Number of DLTs to determine the maximum tolerated dosage. A DLT is defined as any Grade (GR)3 or higher adverse event(AE),GR 1 or higher cardiac arrhythmia;GR 2 or higher vomiting;GR 2 or higher liver dysfunction/failure (clinical);GR 2 elevation of amylase or lipase accompanied by clinical symptoms of pancreatitis.The following GR 2 events are classified as DLTs if evaluated to be clinically significant by the principal investigator or medical safety monitor:decrease of hemoglobin, WBCs, platelets; elevation of AST, ALT,bilirubin;abnormality of Na, K, Cl, Ca, HCO3, glucose, BUN or creatinine.|29 Days|The study was closed prematurely due to poor compliance with study drug administration. The MTD could not be determined as it was less than the lowest dosage studied (500 mg/kg/day).||DLT(s)|||Number
735780|NCT00439608|Secondary|Measure of Safety and Tolerability According to CTC Version 3.0||30 days||||||
735781|NCT00439608|Primary|Reponse Rate at Time of Surgery by Tissue|pathologic complete response rate at surgery|within 30 days of last treatment|||participants|||Number
735782|NCT00439647|Secondary|Serum Beta C-terminal Telopeptides of Type I Collagen(b-CTx) by Visits||Baseline, Month 3, Month 6, Month 12, Month 15, month 18, Month 24|The ITT, Intent to Treat population, includes all participants who received a single a dose of treatment and had data available for analysis. n = the number of subjects with evaluable measurements at visit, as determined by the efficacy window.||ng/mL||Standard Error|Mean
735783|NCT00439647|Secondary|Percentage Change From Baseline in Femoral Neck BMD (g/CM^2)|Dual energy x-ray absorptiometry (DXA) Least Square Means (LSM) were analyzed using an ANCOVA model with treatment and baseline value as explanatory variables. Percent change in total femoral neck BMD at Months 6, 12, and 24 relative to baseline as measured by DXA in a subset of at least 100 evaluable subjects at selected sites. Percentage change from baseline = 100*(endpoint - baseline)|Month 6, Month 12, Month 24|Intent-to-treat (ITT) population included all randomized subjects who had a baseline and at least one post-baseline assessment of the efficacy variable.||Percent change in BMD||Standard Error|Least Squares Mean
735784|NCT00439647|Secondary|Percentage Change From Baseline in Total Hip BMD (g/CM^2)|Dual energy x-ray absorptiometry (DXA) Least Square Means (LSM) were analyzed using an ANCOVA model with treatment and baseline value as explanatory variables. Percent change in total hip BMD at Months 6, 12, and 24 relative to baseline as measured by DXA in a subset of at least 100 evaluable subjects at selected sites. Percentage change from baseline = 100*(endpoint - baseline)|Month 6, Month 12, Month 24|Intent-to-treat (ITT) population included all randomized subjects who had a baseline and at least one post-baseline assessment of the efficacy variable.||Percent change in BMD||Standard Error|Least Squares Mean
735785|NCT00439647|Secondary|Percentage Change From Baseline in Lumbar Spine Bone Mass Density (BMD)|Dual energy x-ray absorptiometry (DXA) Least Square Means (LSM) were analyzed using an ANCOVA model with treatment and baseline value as explanatory variables. Percent change in BMD at lumbar spine at Months 6, 12, and 24 relative to baseline as measured by DXA in a subset of at least 100 evaluable subjects at selected sites. Percentage change from baseline = 100*(endpoint - baseline)|Month 6, Month 12, Month 24|Intent-to-treat (ITT) population included all randomized subjects who had a baseline and at least one post-baseline assessment of the efficacy variable.||Percent change in BMD||Standard Error|Least Squares Mean
735786|NCT00439647|Secondary|Number of Participants With First Non-vertebral Fracture|Non-vertebral fracture is any fracture which was not of the vertebrae. Subjects who did not experience a fracture event were censored at the end of study. End of study was defined as the last visit or date of death, whichever was earlier.|24 months|The ITT (intent to treat) population consisted of all subjects as randomized.||Participants|||Number
735787|NCT00439647|Secondary|Number of Participants With First Clinical Fracture|Clinical fracture is painful fracture in any site which came to clinical attention, e.g., with increased pain, impaired mobility or functional limitations. Subjects who did not experience fracture were censored at end of study. End of study was defined as the earlier of last visit or date of death.|24 months|The ITT (intent to treat) population consisted of all subjects as randomized.||Participants|||Number
735788|NCT00439647|Secondary|Number of Participants With First Clinical Vertebral Fracture|Clinical vertebral fracture is a painful vertebral fracture which came to clinical attention, e.g., with increased back pain, impairment of mobility or functional limitations. Subjects who did not experience a fracture event were censored at the end of study. End of study was defined as the last visit or date of death, whichever was earlier.|24 months|The ITT (intent to treat) population consisted of all subjects as randomized.||Participants|||Number
735789|NCT00439647|Secondary|Mean Change in Height From Baseline|Height was measured using a stadiometer. Two measurements were taken in millimeters (mm), and repeated if the two measurements differed by greater than 4 mm. The average of the two (or four) height measurements was used for analysis|from Baseline to 12 months and 24 months|Modified Intent-to-treat (mITT) population included all randomized subjects who had a baseline and at least one post-baseline assessment of the primary efficacy variable. Patients with a baseline x-ray and a 12M x-ray are included.||mm||Standard Error|Mean
735790|NCT00439647|Secondary|Percentage of Participants With at Least One New or Worsening Morphometric Vertebral Fracture Over 24 Months|Worsening vertebral fracture (VF) was assessed based on morphometry. A QM (quantitative morphometry) incident VF(QM positive) was defined by at least a 20% decrease in any vertebral height (at least 4 mm). If a participant had a QM positive at any vertebrae at any visit,x-rays from all visits for participants were evaluated using Genant semi-quantitative (SQ) method for VF assessment. A worsening fracture was defined as an SQ reading that was greater than the baseline SQ reading, which was at least 1 (prevalent fracture)|Baseline, Month 24|Modified Intent-to-treat (mITT) population included all randomized subjects who had a baseline and at least one post-baseline assessment of the primary efficacy variable. In this analysis, missing Month 24 fractures were imputed using LOCF.||Percentage of Participants|||Number
735791|NCT00439647|Secondary|Percentage of Participants With at Least One New or Worsening Morphometric Vertebral Fracture Over 12 Months|Worsening vertebral fracture (VF) was assessed based on morphometry. QM (quantitative morphometry) incident VF(QM positive) was defined by at least a 20% decrease in any vertebral height (at least 4 mm). If a participant had a QM positive at any vertebrae at any visit, x-rays from all visits for participants were evaluated using Genant semi-quantitative (SQ) method for VF assessment. A worsening fracture was defined as an SQ reading that was greater than the baseline SQ reading, which was at least 1 (prevalent fracture)|Baseline, 12 months|Modified Intent-to-treat (mITT) population included all randomized subjects who had a baseline and at least one post-baseline assessment of the primary efficacy variable. Patients with a baseline x-ray and a 12M x-ray are included.||Percentage of Participants|||Number
735792|NCT00439647|Secondary|Percentage of Participants With at Least One New Moderate or Severe Morphometric Vertebral Fracture Over 24 Months|Moderate or severe vertebral fracture (VF) was assessed based on morphometry. A QM (quantitative morphometry) incident VF(QM positive) was defined by at least a 20% decrease in any vertebral height (at least 4 mm). If a participant had a QM positive at any vertebrae at any visit,x-rays from all visits for participants were evaluated using Genant semi-quantitative (SQ) method for VF assessment. Grade 2 moderate VF was defined as a 25-40% reduction in any vertebral height.Grade 3 Severe: VF was defined as more than 40% reduction in any vertebral height.|24 Months|Modified Intent-to-treat (mITT) population included all randomized subjects who had a baseline and at least one post-baseline assessment of the primary efficacy variable. Patients with a baseline x-ray and a 12M x-ray are included.||Percentage of participants|||Number
735793|NCT00439647|Secondary|Percentage of Participants With at Least One New Moderate or Severe Morphometric Vertebral Fracture Over 12 Months|Moderate or severe vertebral fracture (VF) was assessed based on morphometry. A QM (quantitative morphometry) incident VF(QM positive) was defined by at least a 20% decrease in any vertebral height (at least 4 mm). If a participant had a QM positive at any vertebrae at any visit,x-rays from all visits for participants were evaluated using Genant semi-quantitative (SQ) method for VF assessment. Grade 2 moderate VF was defined as a 25-40% reduction in any vertebral height.Grade 3 Severe: VF was defined as more than 40% reduction in any vertebral height.|12 months|Modified Intent-to-treat (mITT) population included all randomized subjects who had a baseline and at least one post-baseline assessment of the primary efficacy variable. Patients with a baseline x-ray and a 12M x-ray are included.||Percentage of participants|||Number
735794|NCT00439647|Secondary|Percentage of Participants With at Least One New Morphometric Vertebral Fracture Over 12 Months|Vertebral fracture (VF) was assessed based on morphometry. QM(quantitative morphometry) incident VF(QM positive) is defined by at least 20% decrease in vertebral height of at least 4mm. If participant had QM positive at any vertebrae at any visit, x-rays from visits for participants were evaluated using Genant semi-quantitative method for VF assessment: Grade1 Mild VF is defined as 20-24% decrease in anterior, middle, and/or posterior vertebral height. Grade2 moderate VF is defined as 25-40% decrease in vertebral height. Grade3 Severe VF is defined as more than 40% decrease in vertebral height|12 Months|Modified Intent-to-treat (mITT) population included all randomized subjects who had a baseline and at least one post-baseline assessment of the primary efficacy variable. Patients with a baseline x-ray and a 12M x-ray are included.||Percentage of participants|||Number
735803|NCT00439725|Other Pre-specified|Percentage of Participants With Symptomatic Recurrent PE Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either spiral computed tomography (CT) scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, results/films/images of confirmatory testing, and/or case summaries.|6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.||Percentage of participants|||Number
735795|NCT00439647|Primary|Percentage of Participants With at Least One New Morphometric Vertebral Fracture Over 24 Months|Vertebral fracture (VF) was assessed based on morphometry. QM(quantitative morphometry) incident VF(QM positive) is defined by at least 20% decrease in vertebral height of at least 4mm. If participant had QM positive at any vertebrae at any visit, x-rays from visits for participants were evaluated using Genant semi-quantitative method for VF assessment: Grade1 Mild VF is defined as 20-24% decrease in anterior, middle, and/or posterior vertebral height. Grade2 moderate VF is defined as 25-40% decrease in vertebral height. Grade3 Severe VF is defined as more than 40% decrease in vertebral height|24 Months|Modified Intent-to-treat (mITT) population included all randomized subjects who had a baseline and at least one post-baseline assessment of the primary efficacy variable. In this analysis, missing Month 24 fractures were imputed using LOCF.||Percentage of Participants|||Number
735796|NCT00439725|Other Pre-specified|Percentage of Participants With Recurrent DVT During Observational Period|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound or venography, results/films/images of confirmatory testing, and/or case summaries.|30 days observational period after last intake of study medication|Intention-to-treat (ITT) population entering observational period. Participants were analyzed according to the treatment assigned at randomization.||Percentage of participants|||Number
735797|NCT00439725|Other Pre-specified|Percentage of Participants With Recurrent VTE (PE or DVT) During Observational Period|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), results/films/images of confirmatory testing, and/or case summaries.|30 days observational period after last intake of study medication|Intention-to-treat (ITT) population entering observational period. Participants were analyzed according to the treatment assigned at randomization.||Percentage of participants|||Number
735798|NCT00439725|Other Pre-specified|Percentage of Participants With Net Clinical Benefit as Composite of Recurrent DVT or Non-fatal or Fatal PE and Major Bleeding Events During Observational Period|Events were adjudicated/confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral CT scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of 2 or more units, occurring in a critical site or contributing to death.|30 days observational period after last intake of study medication|Intention-to-treat (ITT) population entering observational period. Participants were analyzed according to the treatment assigned at randomization.||Percentage of participants|||Number
735799|NCT00439725|Other Pre-specified|Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE, All Cause Mortality, Strokes and Myocardial Infarctions During Observational Period|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for fatal PE) or unexplained death for which DVT/PE could not be ruled out (for fatal PE), results/films/images of confirmatory testing, and/or case summaries.|30 days observational period after last intake of study medication|Intention-to-treat (ITT) population entering observational period. Participants were analyzed according to the treatment assigned at randomization.||Percentage of participants|||Number
735800|NCT00439725|Other Pre-specified|Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality During Observational Period|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for deaths), results/films/images of confirmatory testing, and/or case summaries.|30 days observational period after last intake of study medication|Intention-to-treat (ITT) population entering observational period. Participants were analyzed according to the treatment assigned at randomization.||Percentage of participants|||Number
735801|NCT00439725|Other Pre-specified|Percentage of Participants With Symptomatic Recurrent PE During Observational Period|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either spiral computed tomography (CT) scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, results/films/images of confirmatory testing, and/or case summaries.|30 days observational period after last intake of study medication|Intention-to-treat (ITT) population entering observational period. Participants were analyzed according to the treatment assigned at randomization.||Percentage of participants|||Number
735802|NCT00439725|Other Pre-specified|Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) During Observational Period|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for fatal PE) or unexplained death for which DVT/PE could not be ruled out (for fatal PE), results/films/images of confirmatory testing, and/or case summaries.|30 days observational period after last intake of study medication|Intention-to-treat (ITT) population entering observational period. Participants were analyzed according to the treatment assigned at randomization.||Percentage of participants|||Number
735804|NCT00439725|Other Pre-specified|Percentage of Participants With Death (PE Cannot be Excluded) Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries.|6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.||Percentage of participants|||Number
735805|NCT00439725|Other Pre-specified|Percentage of Participants With Death (PE) Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either autopsy, results/films/images of confirmatory testing, and/or case summaries.|6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.||Percentage of participants|||Number
735806|NCT00439725|Secondary|Percentage of Participants With Other Vascular Events|All pre-defined vascular events (acute coronary syndromes, ischemic stroke, transient ischemic attack, non-central nervous system systemic embolism and vascular death) were adjudicated/confirmed by a central independent adjudication committee blinded to treatment, based on results/films/images of confirmatory testing, and/or case summaries. On treatment events and all events post randomization were reported. On treatment: after intake of first tablet of study medication as randomized but not more than 1 day after stop of study medication (referred to as time window: 1 day)|6- or 12-month study treatment period|The valid-for-safety analysis population consisted of all participants who were randomized with valid informed consent and received at least one dose of study treatment. For this population, participants were analyzed according to the treatment they received.||Percentage of participants|||Number
735807|NCT00439725|Secondary|Percentage of Participants With All Death|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either autopsy, results/films/images of confirmatory testing, and/or case summaries. Treatment-emergent events and all events post randomization were reported. Treatment-emergent: after intake of first tablet of study medication as randomized but not more than 2 days after stop of study medication (referred to as time window: 2 days)|6- or 12-month study treatment period|The valid-for-safety analysis population consisted of all participants who were randomized with valid informed consent and received at least one dose of study treatment. For this population, participants were analyzed according to the treatment they received.||Percentage of participants|||Number
735808|NCT00439725|Secondary|Percentage of Participants With Clinically Relevant Bleeding|All events adjudicated/confirmed by CIAC blinded to treatment. Clinically relevant bleeding included major bleeding (definition: see outcome 7) and non-major bleeding associated with medical intervention, unscheduled physician contact, (temporary) cessation of study treatment, discomfort for the participants such as pain, or impairment of daily life activities. Treatment-emergent events (after intake of 1st study medication tablet as randomized up to 2 days after stop of study medication [‘time window: 2 days’]) and all events post randomization were reported|6- or 12-month study treatment period|The valid-for-safety analysis population consisted of all participants who were randomized with valid informed consent and received at least one dose of study treatment. For this population, participants were analyzed according to the treatment they received.||Percentage of participants|||Number
735809|NCT00439725|Secondary|Percentage of Participants With Major Bleeding|All events were adjudicated and confirmed by a central independent adjudication committee (CIAC) blinded to treatment. Major bleeding event was overt bleeding associated with a 2 g/dL or greater fall in hemoglobin, leading to a transfusion of 2 or more units of packed red blood cells or whole blood, occurring in a critical site or contributing to death. Treatment-emergent [after intake of first tablet of study medication as randomized but not more than 2 days after stop of study medication (referred to as time window: 2 days)] events and all events post randomization were reported.|6- or 12-month study treatment period|The valid-for-safety analysis population consisted of all participants who were randomized with valid informed consent and received at least one dose of study treatment. For this population, participants were analyzed according to the treatment they received.||Percentage of participants|||Number
735810|NCT00439725|Secondary|Percentage of Participants With Recurrent DVT Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound, venography, results/films/images of confirmatory testing, and/or case summaries.|6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.||Percentage of participants|||Number
735811|NCT00439725|Secondary|Percentage of Participants With Recurrent VTE (PE or DVT) Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), results/films/images of confirmatory testing, and/or case summaries.|6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.||Percentage of participants|||Number
735812|NCT00439725|Secondary|Percentage of Participants With Net Clinical Benefit as Composite of Recurrent DVT or Non-fatal or Fatal PE and Major Bleeding Events Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death.|6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.||Percentage of participants|||Number
735832|NCT00439777|Secondary|Percentage of Participants With All Deaths|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either autopsy, results/films/images of confirmatory testing, and/or case summaries.|3-, 6- or 12-month study treatment period|The valid-for-safety analysis population consisted of all participants who were randomized with valid informed consent and received at least one dose of anticoagulant study treatment after randomization (i.e. enoxaparin, warfarin, acenocoumarol, rivaroxaban). Participants were analyzed according to the treatment they actually received.||Percentage of participants|||Number
735813|NCT00439725|Secondary|Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE, All Cause Mortality, Strokes and Myocardial Infarctions Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), results/films/images of confirmatory testing, and/or case summaries.|6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.||Percentage of participants|||Number
735814|NCT00439725|Secondary|Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), or lung scintigraphy (for PE), and/or case summaries.|6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.||Percentage of participants|||Number
735815|NCT00439725|Primary|Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for fatal PE) or unexplained death for which DVT/PE could not be ruled out (for fatal PE), and/or case summaries. For definition of DVT/PE, kindly refer to the link in the Protocol section.|6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.||Percentage of participants|||Number
735816|NCT00439738|Secondary|Change From Baseline in Postprandial Non-esterified Fatty Acids|After a 75 gram anhydrous glucose challenge 2 hours after an oral glucose tolerance test|Week 16|Only those patients who completed the study through week 16 were included in this analysis||mg/dL||Standard Deviation|Mean
735817|NCT00439738|Secondary|Change From Baseline in Postprandial Insulin|After a 75 gram anhydrous glucose challenge 2 hours after an oral glucose tolerance test|Week 16|Only those patients who completed the study through week 16 were included in this analysis||mg/dL||Standard Deviation|Mean
735818|NCT00439738|Secondary|Change From Baseline in Postprandial Glucose|After a 75 gram anhydrous glucose challenge 2 hours after an oral glucose tolerance test|Week 16|Only those patients who completed the study through week 16 were included in this analysis.||mg/dL||Standard Deviation|Mean
735819|NCT00439738|Secondary|Number of Patients Achieving Blood Pressure (BP)Control by Visit (< 130/80 mm Hg)|Mean sitting systolic blood pressure/mean sitting diastolic blood pressure < 130/80 mm Hg|Week 4, 8, 12, 16, End of Study (for patients that did not complete the last visit at week 16)|Intent to Treat (ITT)||participants|||Number
735820|NCT00439738|Secondary|Number of Patients Achieving Blood Pressure (BP) Control by Visit (< 140/90 mm Hg)|Mean sitting systolic blood pressure/mean sitting diastolic blood pressure < 140/90 mm Hg|Weeks 4, 8, 12 16 and End of Study (for patients that did not complete the last visit at week 16)|Intent to Treat (ITT)||participants|||Number
735821|NCT00439738|Secondary|Change in Mean Sitting Diastolic Blood Pressure (MSDBP)||Baseline to Weeks 4, 8, 12 and 16|Intent to Treat (ITT), Last Observation Carried Forward (LOCF)||mm Hg||Standard Deviation|Mean
735822|NCT00439738|Primary|Change in Mean Sitting Systolic Blood Pressure (MSSBP)||Baseline to Week 8|Intent to Treat (ITT), Last Observation Carried Forward (LOCF)||mm Hg||Standard Deviation|Mean
735823|NCT00439777|Post-Hoc|Percentage of Participants With an Event for Net Clinical Benefit 2 During Observational Period|Net clinical benefit 2: composite of recurrent DVT or non-fatal or fatal PE, major bleeding (associated with 2 g/dL or greater fall in hemoglobin, leading to transfusion of ≥2 units, occurring in a critical site or contributing to death), cardiovascular death, myocardial infarction, stroke, and non CNS (central nervous system) systemic embolism. Net clinical benefit was considered greater in those participants with fewer composite events. All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound (DVT), venography (DVT), spiral CT scanning (PE), pulmonary angiography (PE), ventilation/perfusion lung scan (PE), lung scintigraphy (PE), autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries.|Up to 30 days after the last intake of study medication|Participants entering the observational period were participants for whom the investigator indicated on the eCRF that the participant entered the observational period or had a confirmed event more than one day and up to 30 days after the last dose as a component of the respective composite outcome.||Percentage of participants|||Number
735824|NCT00439777|Post-Hoc|Percentage of Participants With an Event for Net Clinical Benefit 2 Until the Intended End of Study Treatment|Net clinical benefit 2: composite of recurrent DVT or non-fatal or fatal PE, major bleeding (associated with 2 g/dL or greater fall in hemoglobin, leading to transfusion of ≥2 units, occurring in a critical site or contributing to death), cardiovascular death, myocardial infarction, stroke, and non CNS (central nervous system) systemic embolism. Net clinical benefit was considered greater in those participants with fewer composite events. All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound (DVT), venography (DVT), spiral CT scanning (PE), pulmonary angiography (PE), ventilation/perfusion lung scan (PE), lung scintigraphy (PE), autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries.|3-, 6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.||Percentage of participants|||Number
735825|NCT00439777|Other Pre-specified|Percentage of Participants With the Individual Components of Efficacy Outcomes During Observational Period|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death.|Up to 30 days after the last intake of study medication|Participants entering the observational period were participants for whom the investigator indicated on the eCRF that the participant entered the observational period or had a confirmed event more than one day and up to 30 days after the last dose as a component of the respective composite outcome.||Percentage of participants|||Number
735826|NCT00439777|Other Pre-specified|Percentage of Participants With Recurrent DVT During Observational Period|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound, venography, results/films/images of confirmatory testing, and/or case summaries.|Up to 30 days after the last intake of study medication|Participants entering the observational period were participants for whom the investigator indicated on the eCRF that the participant entered the observational period or had a confirmed event more than one day and up to 30 days after the last dose as a component of the respective composite outcome.||Percentage of participants|||Number
735827|NCT00439777|Other Pre-specified|Percentage of Participants With an Event for Net Clinical Benefit 1 During Observational Period|Net clinical benefit 1: composite of recurrent DVT or non-fatal or fatal PE, and major bleeding. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death. Net clinical benefit was considered greater in those participants with fewer composite events. All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries.|Up to 30 days after the last intake of study medication|Participants entering the observational period were participants for whom the investigator indicated on the eCRF that the participant entered the observational period or had a confirmed event more than one day and up to 30 days after the last dose as a component of the respective composite outcome.||Percentage of participants|||Number
735828|NCT00439777|Other Pre-specified|Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality During Observational Period|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for deaths), results/films/images of confirmatory testing, and/or case summaries.|Up to 30 days after the last intake of study medication|Participants entering the observational period were participants for whom the investigator indicated on the eCRF that the participant entered the observational period or had a confirmed event more than one day and up to 30 days after the last dose as a component of the respective composite outcome.||Percentage of participants|||Number
735829|NCT00439777|Other Pre-specified|Percentage of Participants With Symptomatic Recurrent VTE (i.e. the Composite of Recurrent DVT or Fatal or Non-fatal PE) During Observational Period|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for fatal PE) or unexplained death for which DVT/PE could not be ruled out (for fatal PE), and/or case summaries.|Up to 30 days after the last intake of study medication|Participants entering the observational period were participants for whom the investigator indicated on the eCRF (electronic case report form) that the participant entered the observational period or had a confirmed event more than one day and up to 30 days after the last dose as a component of the respective composite outcome.||Percentage of participants|||Number
735830|NCT00439777|Other Pre-specified|Percentage of Participants With the Individual Components of Efficacy Outcomes Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death.|3-, 6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.||Percentage of participants|||Number
735831|NCT00439777|Secondary|Percentage of Participants With Other Vascular Events, On-treatment (Time Window: Until 1 Day After Last Dose)|All pre-defined vascular events (ST segment elevation myocardial infarction, non ST segment elevation myocardial infarction, unstable angina, ischemic stroke, transient ischemic attack, non-central nervous system systemic embolism or vascular death) were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based results/films/images of confirmatory testing, and/or case summaries.|3-, 6- or 12-month study treatment period|The valid-for-safety analysis population consisted of all participants who were randomized with valid informed consent and received at least one dose of anticoagulant study treatment after randomization (i.e. enoxaparin, warfarin, acenocoumarol, rivaroxaban). Participants were analyzed according to the treatment they actually received.||Percentage of participants|||Number
735858|NCT00440050|Primary|Rate of Change on the ADAS-Cog 11.|ADAS-cog 11 = Alzheimer's Disease Assessment Scale, cognitive sub-scale in points per year. This is a psychometric measure sensitive to change in mild to moderate AD. The range of this instrument is 0 to 70 with higher numbers indicating greater impairment.|Baseline, 6, 12, 18 months|||ADAS points per year||Standard Deviation|Mean
735833|NCT00439777|Secondary|Percentage of Participants With Clinically Relevant Bleeding, Treatment-emergent (Time Window: Until 2 Days After Last Dose)|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Clinically relevant bleeding included major bleeding (overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of 2 or more units of packed red blood cells or whole blood, occurring in a critical site or contributing to death) and non-major bleeding associated with medical intervention, unscheduled physician contact, (temporary) cessation of study treatment, discomfort for the participants such as pain, or impairment of activities of daily life.|3-, 6- or 12-month study treatment period|The valid-for-safety analysis population consisted of all participants who were randomized with valid informed consent and received at least one dose of anticoagulant study treatment after randomization (i.e. enoxaparin, warfarin, acenocoumarol, rivaroxaban). Participants were analyzed according to the treatment they actually received.||Percentage of participants|||Number
735834|NCT00439777|Secondary|Percentage of Participants With Recurrent DVT Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound, venography, results/films/images of confirmatory testing, and/or case summaries.|3-, 6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.||Percentage of participants|||Number
735835|NCT00439777|Secondary|Percentage of Participants With Recurrent PE Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries.|3-, 6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.||Percentage of participants|||Number
735836|NCT00439777|Secondary|Percentage of Participants With an Event for Net Clinical Benefit 1 Until the Intended End of Study Treatment|Net clinical benefit 1: composite of recurrent DVT or non-fatal or fatal PE, and major bleeding. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death. Net clinical benefit was considered greater in those participants with fewer composite events. All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries.|3-, 6-, or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.||Percentage of participants|||Number
735837|NCT00439777|Secondary|Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for deaths), results/films/images of confirmatory testing, and/or case summaries.|3-, 6-, or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.||Percentage of participants|||Number
735838|NCT00439777|Primary|Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for fatal PE) or unexplained death for which DVT/PE could not be ruled out (for fatal PE), and/or case summaries.|3-, 6-, or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.||Percentage of participants|||Number
735839|NCT00439946|Secondary|Subject Responses to the Patient Impression of Change Questionnaire (Administered at Week 8 Only)|A Patient Global Impression of Change Questionnaire, which consists of three items that ask the subject to rate changes (much better, somewhat better, about the same, somewhat worse, much worse) in their symptoms of PAH, the amount of time spent on activities associated with preparing and administering PAH therapy, and their satisfaction with their PAH therapy since transitioning from epoprostenol to intravenous Remodulin was conducted at Week 8 only and responses are reported as frequency distributions.|Week 8|||participants|||Number
735840|NCT00439946|Secondary|Change From Baseline at Week 8 in Score on Treatment Satisfaction Questionnaire- The Treatment Satisfaction Questionnaire for Medication (TSQM)|The Treatment Satisfaction Questionnaire for Medication (TSQM), a validated generic measure of treatment satisfaction consisting of 14 Likert-response items comprising four domains: Effectiveness, Side Effects, Convenience, and Global Satisfaction. The TSQM was completed at baseline and at Week 8. The TSQM consists of 13 items that made up three specific scales (Effectiveness, Side effects, Convenience) and one global satisfaction scale. TSQM items are scaled using either a 5-point or 7-point scale. Five-point scales are used for unidimensional continua (e.g. extremely satisfied to not at all), while 7-point scales are used for bipolar continua (e.g., extremely positive to extremely negative. Non-neutral midpoints are used for 7-point scales, resulting in a greater range of positive response options than negative options for these items. Scale scores are transformed into scores ranging from 0 to 100, with a higher score indicating more satisfaction.|Baseline and Week 8|All 8 participants are included.||units on a scale||Standard Deviation|Mean
735859|NCT00440115|Secondary|Progress in Stage of Change|Progress in Stages of Change at 6, 12, 18, and 24 months|6, 12, 18, 24 months|||Participants|||Count of Participants
735841|NCT00439946|Secondary|Change From Baseline at Week 8 in Score on Quality of Life (QOL) Questionnaire - The Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR)|The Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR), a validated PAH-specific instrument consisting of 65 items used to assess symptoms, functioning and QOL. The CAMPHOR was completed at Baseline and at Week 8. The CAMPHOR consists of 3 scales: 1. A 25-item overall symptoms scale scored 0–25, with a higher score indicating the presence of more symptoms. 2. A 15 item Activity/Functioning scale scored 0–30, where a low score indicates good functioning. 3. A 25-item QoL scale scored 0–25, with a high score indicating poor QoL. Additionally, a total score was recorded by adding up the the scores from the 3 above scales. The Symptom and QoL scales have dichotomous (‘True’/‘Not true’) response options while the Activity/Functioning scale has three-point (‘Able to do on own without difficulty’/‘Able to do on own with difficulty’/‘Unable to do on own’) response options. Reduction in score denotes improved heath status.|Baseline and Week 8|One subject was missing a questionnaire page of the CAMPHOR; Therefore, the component score of||units on a scale||Standard Deviation|Mean
735842|NCT00439946|Secondary|Total Weekly Time Spent With the Specific Activities Associated With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol|A Drug Administration Activities Diary, used by subjects to record in detail the amount of time (in minutes) spent on specifically-defined drug preparation/administration activities (e.g. diluting drug, preparing reservoir, and changing tubing), was completed over a 7-day period during the Screening period while on epoprostenol and repeated at Week 7 following transition to Remodulin.|Week 8|||minutes||Standard Deviation|Mean
735843|NCT00439946|Secondary|Change From Baseline at Week 8 in PAH Symptoms- Chest Pain|The presence or absence of chest pain was documented. If present, the intensity of chest pain was rated mild, moderate, or severe.|Week 8|All Subjects transitioned from IV epoprostenol to IV treprostinil were included.||participants|||Number
735844|NCT00439946|Secondary|Change From Baseline at Week 8 in PAH Symptoms- Syncope|The presence or absence of syncope was documented. If present, the intensity of syncope was rated mild, moderate, or severe.|Week 8|All Subjects transitioned from IV epoprostenol to IV treprostinil were included.||participants|||Number
735845|NCT00439946|Secondary|Change From Baseline at Week 8 in PAH Symptoms- Dizziness|The presence or absence of dizziness was documented. If present, the intensity of dizziness was rated mild, moderate, or severe.|Week 8|All Subjects transitioned from IV epoprostenol to IV treprostinil were included.||participants|||Number
735846|NCT00439946|Secondary|Change From Baseline at Week 8 in PAH Symptoms- Orthopnea|The presence or absence of orthopnea was documented. If present, the intensity of orthopnea was rated mild, moderate, or severe.|Week 8|All Subjects transitioned from IV epoprostenol to IV treprostinil were included||participants|||Number
735847|NCT00439946|Secondary|Change From Baseline at Week 8 in Symptoms of PAH- Edema|The presence or absence of edema was documented. If present, the intensity of edema was rated mild, moderate, or severe.|Week 8|All Subjects transitioned from IV epoprostenol to IV treprostinil were included||participants|||Number
735848|NCT00439946|Secondary|Change From Baseline at Week 8 in Symptoms of PAH- Dyspnea|The presence or absence of dyspnea was documented. If present, the intensity of dyspnea was rated mild, moderate, or severe.|Week 8|All Subjects transitioned from IV epoprostenol to IV treprostinil were included||participants|||Number
735849|NCT00439946|Secondary|Change From Baseline at Week 8 in Symptoms of PAH- Fatigue|The presence or absence of fatigue was documented. If present, the intensity of fatigue was rated mild, moderate, or severe.|Week 8|All Subjects transitioned from IV epoprostenol to IV treprostinil were included.||participants|||Number
735850|NCT00439946|Secondary|Change From Baseline at Week 8 in World Health Organization (WHO) Functional Classification|WHO functional class is a system to help clinicians determine how limited a patient is in their ability to do the activities of daily living. The scale ranges from class I to class IV. In general, patients with more severe Pulmonary Hypertension (PH) tend to have a higher functional class.|Week 8|All Subjects transitioned from IV epoprostenol to IV treprostinil were included.||participants|||Number
735851|NCT00439946|Secondary|Change From Baseline at Week 8 in Borg Dyspnea Score Immediately After Six Minute Walk Test|The Borg dyspnea score is a 10-point scale rating the maximum level of dyspnea experienced during the 6-Minute Walk Test. Scores range from 0 (for the best condition) to 10 (for the worst condition).|Week 8|Two subjects did not have Baseline Borg scores and were excluded from this analysis.||units on a scale||Standard Deviation|Mean
735852|NCT00439946|Primary|Change From Baseline at Week 8 in 6-Minute Walk Distance (6MWD)|The administration of the 6MWD test and specifications of the testing area were consistent with the American Thoracic Society guidelines and the usual practice of the investigative site [American Thoracic Society (ATS) guidelines; 2002].|Week 8|Two subjects did not have Baseline 6MWTs and were excluded from this analysis.||meters||Standard Deviation|Mean
735853|NCT00440011|Secondary|Tolerability - Conjunctival Hyperemia|Conjunctival Hyperemia: Number of participants with at least 1 grade increase in severity from baseline. A five grade scale from 0 to 3 (0 = none, +0.5 = trace, 1 = mild, 2 = moderate, 3 = severe)|Month 3|||participants|||Number
735854|NCT00440011|Primary|Intraocular Pressure (IOP)|Intraocular Pressure|Month 3|||mm Hg||Standard Deviation|Mean
735855|NCT00440050|Secondary|Neuropsychiatric Inventory (NPI)|The Neuropsychiatric Inventory quantifies behavioral changes in dementia, including depression, anxiety, psychosis, agitation, sleep change, appetite change, and others. This is a structured questionnaire administered to the subject's caregiver/study partner. The range of this instrument is 0 to 120 with higher numbers indicating greater impairment.|18 months|||Units on a scale||Standard Deviation|Mean
735856|NCT00440050|Secondary|ADCS-ADL|ADCS-ADL = Alzheimer's Disease Cooperative Study Activities of Daily Living Score. This is a structured questionnaire about activities of daily living, administered to the subject's caregiver/study partner. The range of this instrument is 0 to 6 with lower numbers indicating greater impairment.|18 months|||Units on a scale||Standard Deviation|Mean
735857|NCT00440050|Primary|Rate of Change on CDR-SOB|CDR-SOB = Clinical Dementia Rating, Sum of Boxes. This is a global rating of dementia severity based on the clinician's interpretation of the history and examination. The range of this instrument is 0 to 18 with higher numbers indicating greater impairment.|18 months|||Units on a scale||Standard Deviation|Mean
735860|NCT00440115|Secondary|Number of Quit Attempts|Number of quit attempts at 6, 12, 18, and 24 months. A quit attempt is defined as use of quit-smoking pharmacotherapy (nicotine patch or bupropion) during each treatment period.|6, 12, 18, 24 months|||quit attempts|||Number
735861|NCT00440115|Primary|7-day Point Prevalence Abstinence From Cigarettes|Self-reported 7-day point prevalence abstinence from cigarettes|24 months|We used generalized linear models for the primary endpoint (self-reported abstinence at 24 months). Missing values were imputed as smokers, deaths and incarcerations were excluded from analysis.||Participants|||Count of Participants
735862|NCT00440180|Primary|Pregnancy Rate|Partner pregnancy rate during study participation|4 months|||participants partner|||Number
735863|NCT00440193|Post-Hoc|Percentage of Participants With an Event for Net Clinical Benefit 2 During Observational Period|Net clinical benefit 2: composite of recurrent DVT or non-fatal or fatal PE, major bleeding, cardiovascular death, myocardial infarctions, stroke, or non CNS systemic embolism. Major bleeding was associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death. Net clinical benefit was considered greater in those participants with fewer composite events. All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound (DVT), venography (DVT), spiral CT scanning (PE), pulmonary angiography ( PE), ventilation/perfusion lung scan (PE), lung scintigraphy (PE), autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries.|Up to 30 days after the last intake of study medication|Participants entering the observational period were participants for whom the investigator indicated on the eCRF that the participant entered the observational period or had a confirmed event more than one day and up to 30 days after the last dose as a component of the respective composite outcome.||Percentage of participants|||Number
735864|NCT00440193|Post-Hoc|Percentage of Participants With an Event for Net Clinical Benefit 2 Until the Intended End of Study Treatment|Net clinical benefit 2: composite of recurrent DVT or non-fatal or fatal PE, major bleeding. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to transfusion of ≥2 units, occurring in a critical site or contributing to death, cardiovascular death, myocardial infarction, stroke, and non CNS (central nervous system) systemic embolism. Net clinical benefit was considered greater in those participants with fewer composite events. All events confirmed by independent committee blinded to treatment, based on compression ultrasound, venography, spiral CT scan, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy, results/films/images of confirmatory testing and/or case summaries|3-, 6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.||Percentage of participants|||Number
735865|NCT00440193|Other Pre-specified|Percentage of Participants With the Individual Components of Efficacy Outcomes During Observational Period|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death.|Up to 30 days after the last intake of study medication|Participants entering the observational period were participants for whom the investigator indicated on the eCRF that the participant entered the observational period or had a confirmed event more than one day and up to 30 days after the last dose as a component of the respective composite outcome.||Percentage of participants|||Number
735866|NCT00440193|Other Pre-specified|Percentage of Participants With Recurrent DVT During Observational Period|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound, venography, results/films/images of confirmatory testing, and/or case summaries.|Up to 30 days after the last intake of study medication|Participants entering the observational period were participants for whom the investigator indicated on the eCRF that the participant entered the observational period or had a confirmed event more than one day and up to 30 days after the last dose as a component of the respective composite outcome.||Percentage of participants|||Number
735867|NCT00440193|Other Pre-specified|Percentage of Participants With an Event for Net Clinical Benefit 1 During Observational Period|Net clinical benefit 1: composite of recurrent DVT or non-fatal or fatal PE or major bleeding. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death. Net clinical benefit was considered greater in those participants with fewer composite events. All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries.|Up to 30 days after the last intake of study medication|Participants entering the observational period were participants for whom the investigator indicated on the eCRF that the participant entered the observational period or had a confirmed event more than one day and up to 30 days after the last dose as a component of the respective composite outcome.||Percentage of participants|||Number
735868|NCT00440193|Other Pre-specified|Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality During Observational Period|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for deaths), results/films/images of confirmatory testing, and/or case summaries.|Up to 30 days after the last intake of study medication|Participants entering the observational period were participants for whom the investigator indicated on the eCRF that the participant entered the observational period or had a confirmed event more than one day and up to 30 days after the last dose as a component of the respective composite outcome.||Percentage of participants|||Number
735889|NCT00431496|Secondary|Number of Participants Who Achieved a Mean Phosphorus Value ≥ 1.13 and ≤ 1.78 mmol/L|The number of participants who achieved a mean serum phosphorus value ≥ 1.13 and ≤ 1.78 mmol/L (3.5 to 5.5 mg/dL) during the effectiveness assessment phase.|Weeks 17 to 23|All participants who received cinacalcet||Participants|||Number
735869|NCT00440193|Other Pre-specified|Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) During Observational Period|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for fatal PE) or unexplained death for which DVT/PE could not be ruled out (for fatal PE), results/films/images of confirmatory testing, and/or case summaries.|Up to 30 days after the last intake of study medication|Participants entering the observational period were participants for whom the investigator indicated on the eCRF (electronic case report form) that the participant entered the observational period or had a confirmed event more than one day and up to 30 days after the last dose as a component of the respective composite outcome.||Percentage of participants|||Number
735870|NCT00440193|Other Pre-specified|Percentage of Participants With the Individual Components of Efficacy Outcomes Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death.|3-, 6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.||Percentage of participants|||Number
735871|NCT00440193|Secondary|Percentage of Participants With Other Vascular Events, On-treatment (Time Window: Until 1 Day After Last Dose)|All pre-defined vascular events (ST segment elevation myocardial infarction, non ST segment elevation myocardial infarction, unstable angina, ischemic stroke, transient ischemic attack, non-central nervous system systemic embolism or vascular death) were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based results/films/images of confirmatory testing, and/or case summaries.|3-, 6- or 12-month study treatment period|The valid-for-safety analysis population consisted of all participants who were randomized with valid informed consent and received at least one dose of anticoagulant study treatment after randomization (i.e. enoxaparin, warfarin, acenocoumarol, rivaroxaban). Participants were analyzed according to the treatment they actually received.||Percentage of participants|||Number
735872|NCT00440193|Secondary|Percentage of Participants With All Deaths|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either autopsy, results/films/images of confirmatory testing, and/or case summaries.|3-, 6- or 12-month study treatment period|The valid-for-safety analysis population consisted of all participants who were randomized with valid informed consent and received at least one dose of anticoagulant study treatment after randomization (i.e. enoxaparin, warfarin, acenocoumarol, rivaroxaban). Participants were analyzed according to the treatment they actually received.||Percentage of participants|||Number
735873|NCT00440193|Secondary|Percentage of Participants With Clinically Relevant Bleeding, Treatment-emergent (Time Window: Until 2 Days After Last Dose)|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Clinically relevant bleeding included major bleeding (overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of 2 or more units of packed red blood cells or whole blood, occurring in a critical site or contributing to death) and non-major bleeding associated with medical intervention, unscheduled physician contact, (temporary) cessation of study treatment, discomfort for the participants such as pain, or impairment of activities of daily life.|3-, 6- or 12-month study treatment period|The valid-for-safety analysis population consisted of all participants who were randomized with valid informed consent and received at least one dose of anticoagulant study treatment after randomization (i.e. enoxaparin, warfarin, acenocoumarol, rivaroxaban). Participants were analyzed according to the treatment they actually received.||Percentage of participants|||Number
735874|NCT00440193|Secondary|Percentage of Participants With Recurrent DVT Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound, venography, results/films/images of confirmatory testing, and/or case summaries.|3-, 6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.||Percentage of participants|||Number
735875|NCT00440193|Secondary|Percentage of Participants With an Event for Net Clinical Benefit 1 Until the Intended End of Study Treatment|Net clinical benefit 1: composite of recurrent DVT or non-fatal or fatal PE, and major bleeding. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death. Net clinical benefit was considered greater in those participants with fewer composite events. All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries.|3-, 6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.||Percentage of participants|||Number
735890|NCT00431496|Secondary|Number of Participants Who Achieved a Mean Calcium Value ≥ 2.1 and ≤ 2.37 mmol/L|The number of participants who achieved a mean corrected serum calcium (Ca) value ≥ 2.1 and ≤ 2.37 mmol/L (8.4 to 9.5 mg/dL) during the effectiveness assessment phase.|Weeks 17 to 23|All participants who received cinacalcet||Participants|||Number
735891|NCT00431496|Secondary|Number of Participants Who Achieved a Mean Ca x P Value < 4.44 mmol^2/L^2 (55 mg^2/dL^2)|The number of participants who achieved a mean serum calcium x phosphorus (Ca x P) value < 4.44 mmol^2/L^2 (55 mg^2/dL^2) during the effectiveness assessment phase. The calcium - phosphorus product is a derived value calculated from serum calcium and phosphorus levels.|Weeks 17 to 23|All participants who received cinacalcet||Participants|||Number
735876|NCT00440193|Secondary|Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for deaths), results/films/images of confirmatory testing, and/or case summaries.|3-, 6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.||Percentage of participants|||Number
735877|NCT00440193|Primary|Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for fatal PE) or unexplained death for which DVT/PE could not be ruled out (for fatal PE), and/or case summaries.|3-, 6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.||Percentage of participants|||Number
735878|NCT00431444|Secondary|Patient Preference at 6 Months for Annual i.v Therapy or Daily Oral Regimens|At the end-of-study visit, Month 6, patients were asked to complete a questionnaire to assess preference for the different treatment modalities (annual i.v. infusion vs. daily oral capsule). The possible answers to question were: “once a year i.v. infusion,” “once daily pill,” or “both are equal.”|At 6 month visit|Intention-to-treat (ITT) population.||Participants|||Number
735879|NCT00431444|Secondary|Overall Patient Satisfaction Assessed by Satisfaction Questionnaire|Patients were asked to complete the satisfaction questionnaire at baseline. The questionnaire assessed overall satisfaction with the i.v. infusion procedure. The possible answers to the question were: “not at all,” “a little,” “somewhat,” “quite,” or “completely.”|Immediately after infusion procedure|Intention-to-treat (ITT) population.||Participants|||Number
735880|NCT00431444|Secondary|Overall Nurse Satisfaction Assessed by Satisfaction Questionnaire|The study coordinator (nurse) was asked to complete satisfaction questionnaires at baseline (Visit 2/Day 1) when each patient’s i.v. drug administration occurred. The questionnaire assessed overall satisfaction with the i.v. infusion procedure. The possible answers to the question were: “not at all,” “a little,” “somewhat,” “quite,” or “completely.”|Immediately after infusion procedure|Intention-to-treat (ITT) population.||Participants|||Number
735881|NCT00431444|Secondary|Overall Principal Investigator Satisfaction Assessed by Satisfaction Questionnaire|The investigator was asked to complete satisfaction questionnaires at baseline (Visit 2/Day 1) when each patient’s i.v. drug administration occurred. The questionnaire assessed overall satisfaction with the i.v. infusion procedure. The possible answers to the question were: “not at all,” “a little,” “somewhat,” “quite,” or “completely.”|Immediately after infusion procedure|Intention-to-treat (ITT) population.||Participants|||Number
735882|NCT00431444|Secondary|Change From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 6 Months||Baseline and 6 months|The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of the primary efficacy variable of urine N-telopeptide of Type 1 collagen (NTx).Observed cases were used, no imputation was performed.||U/L||Standard Deviation|Mean
735883|NCT00431444|Secondary|Change From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 4 Months||Baseline and 4 months|The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of the primary efficacy variable of urine N-telopeptide of Type 1 collagen (NTx).Observed cases were used, no imputation was performed.||U/L||Standard Deviation|Mean
735884|NCT00431444|Secondary|Change From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 2 Months||Baseline and 2 months|The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of the primary efficacy variable of urine N-telopeptide of Type 1 collagen (NTx).Observed cases were used, no imputation was performed.||U/L||Standard Deviation|Mean
735885|NCT00431444|Secondary|Change From Baseline in Urine NTx at 4 Months|The results are reported as nanomoles (nM) of bone collagen equivalents (BCE) per millimole (mM) of urine creatinine.|Baseline and 4 months|The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of the primary efficacy variable of urine N-telopeptide of Type 1 collagen (NTx).Observed cases were used, no imputation was performed.||nM BCE/mM Cr||Standard Deviation|Mean
735886|NCT00431444|Secondary|Change From Baseline in Urine NTx at 2 Months|The results are reported as nanomoles (nM) of bone collagen equivalents (BCE) per millimole (mM) of urine creatinine.|Baseline and 2 months|The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of the primary efficacy variable of urine N-telopeptide of Type 1 collagen (NTx).Observed cases were used, no imputation was performed.||nM BCE/mM Cr||Standard Deviation|Mean
735887|NCT00431444|Primary|Change From Baseline in Urine N-telopeptide of Type 1 Collagen (NTx.)|The primary efficacy variable was the change from baseline in urine NTx (corrected by creatinine). The primary analysis time point was at 6 months of treatment. The results are reported as nanomoles (nM) of bone collagen equivalents (BCE) per millimole (mM) of urine creatinine.|Baseline and 6 months|The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of the primary efficacy variable of urine N-telopeptide of Type 1 collagen (NTx).Observed cases were used, no imputation was performed.||nM BCE/mM Cr||Standard Deviation|Mean
735888|NCT00431496|Secondary|Number of Participants Who Achieved a Mean CRP < 0.6 mg/dL|The number of participants who achieved a mean C-reactive protein (CRP) level of < 0.6 mg/dL during the effectiveness assessment phase.|Weeks 17 to 23|All participants who received cinacalcet||Participants|||Number
735892|NCT00431496|Secondary|Number of Participants Who Achieved a Mean iPTH Value Between 150 and 300 pg/mL|Number of participants who achieved a mean intact Parathyroid Hormone (iPTH) value greater than or equal to 15.9 and less than or equal to 31.8 pmol/L (150 - 300 pg/mL) during the effectiveness assessment phase.|Weeks 17 to 23|All participants who received cinacalcet||Participants|||Number
735893|NCT00431496|Primary|Number of Participants With a Mean Intact Parathyroid Hormone Value Between 150 and 300 pg/mL and a Calcium - Phosphorus Product Value < 55 mg^2/dL^2|The National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF K/DOQI) recommends that treatment interventions to control parathyroid hormone should not result in significant elevation of calcium - phosphorus product (Ca x P; a derived value calculated from serum calcium and phosphorus levels). The primary objective of the study was to assess the simultaneous achievement of NKF K/DOQI targets of intact parathyroid hormone (iPTH) greater than or equal to 15.9 pmol/L and less than or equal to 31.8 pmol/L (150 - 300 pg/mL) and a Ca x P value < 4.44 mmol^2/L^2 (55 mg^2/dL^2) during the effectiveness assessment phase.|Weeks 17 to 23|All participants who received cinacalcet||Participants|||Number
735894|NCT00431626|Primary|Primary Outcome Measure Will be the 5 Point Change in AUA Symptom Index|AUA symptoms index change is measured on a five level-scale: -2 (much worse), -1(worse) , 0 (no change), 1 (better), 2 (much better)|one year|||units on a scale||Standard Deviation|Mean
735895|NCT00431834|Primary|Safety Endpoint: Composite Acute Major Adverse Event Rate, Within 30 Days Post-procedure or Hospital Discharge|Major Adverse Events included: mediastinitis, death, myocardial infarction, stroke, transient ischemic attacks (TIA), pulmonary embolism, peripheral arterial embolism, and esophageal injury.|30 days post procedure or hospital discharge|Entire study population.||Percentage of subjects||95% Confidence Interval|Number
735896|NCT00431834|Secondary|Safety Endpoints: Composite 6-month Major Adverse Event Rate, Post-procedure|Major Adverse Events included: mediastinitis, death, myocardial infarction, stroke, transient ischemic attacks (TIA), pulmonary embolism, peripheral arterial embolism, and esophageal injury.|6 months|All subjects who were enrolled and were treated with the Cardioblate surgical ablation system with at least 6-month post-operative follow-up or an MAE prior to the end of the 6th month window were included in the analysis.||percentage of subjects|||Number
735897|NCT00431834|Secondary|Efficacy Endpoints: The Percent of Patients Out of AF, Regardless of Antiarrhythmic Drug Status, as Determined by a 24 Hour Holter Recording at 6 Months||6 months|75 subjects were enrolled. 14 subjects had no holter analysis performed- 1 LTFU, 3 died,7 withdrew participation, 3 subjects without analyzable holter data.||percentage of subjects|||Number
735898|NCT00431834|Primary|Efficacy Endpoint: The Percent of Patients Off Class I and/or III Antiarrhythmic Drugs and Out of Atrial Fibrillation as Determined by 24 Hour Holter Recording Conducted at 6 Months Postoperatively.|Subject's heart rhythm was evaulated by wearing a Holter Monitor for 24 hours.|6 months|75 subjects were enrolled. 14 subjects had no holter analysis performed- 1 LTFU, 3 died,7 withdrew participation, 3 subjects without analyzable holter data.||percentage of participants||95% Confidence Interval|Number
735899|NCT00431847|Primary|Treatment Outcomes in Pain Survey (TOPS): Solicitous Responses|Treatment Outcomes in Pain Survey (TOPS): The 112-item TOPS explicitly acknowledges and measures contextual factors that are important in pain treatment including the dimensions of pain symptoms, fear avoidance, patient satisfaction with outcomes, and health care satisfaction. TOPS scoring ranges from 100, the worst possible score where pain impacts all components of the health domain, to 0, the best possible response where pain does not interfere with any component in the domain.|Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months|||units on TOPS scale||Standard Error|Mean
735900|NCT00431847|Primary|Treatment Outcomes in Pain Survey (TOPS): Pain Symptoms|Treatment Outcomes in Pain Survey (TOPS): The 112-item TOPS explicitly acknowledges and measures contextual factors that are important in pain treatment including the dimensions of pain symptoms, fear avoidance, patient satisfaction with outcomes, and health care satisfaction. TOPS scoring ranges from 100, the worst possible score where pain impacts all components of the health domain, to 0, the best possible response where pain does not interfere with any component in the domain.|Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months|||units on TOPS scale||Standard Error|Mean
735901|NCT00431847|Primary|Treatment Outcomes in Pain Survey (TOPS): Patient Satisfaction With Outcomes|Treatment Outcomes in Pain Survey (TOPS): The 112-item TOPS explicitly acknowledges and measures contextual factors that are important in pain treatment including the dimensions of pain symptoms, fear avoidance, patient satisfaction with outcomes, and health care satisfaction. For the satisfaction with outcomes scale of the TOPS, scoring ranges from 100, the best possible score where satisfaction is optimal, to 0, least satisfied.|Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months|||units on TOPS scale||Standard Error|Mean
735902|NCT00431847|Primary|Treatment Outcomes in Pain Survey (TOPS): Observed Family Social Disability|Treatment Outcomes in Pain Survey (TOPS): The 112-item TOPS explicitly acknowledges and measures contextual factors that are important in pain treatment including the dimensions of pain symptoms, fear avoidance, patient satisfaction with outcomes, and health care satisfaction. TOPS scoring ranges from 100, the worst possible score where pain impacts all components of the health domain, to 0, the best possible response where pain does not interfere with any component in the domain.|Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months|||units on TOPS scale||Standard Error|Mean
735903|NCT00431847|Primary|Treatment Outcomes in Pain Survey (TOPS):Life Control|Treatment Outcomes in Pain Survey (TOPS): The 112-item TOPS explicitly acknowledges and measures contextual factors that are important in pain treatment including the dimensions of pain symptoms, fear avoidance, patient satisfaction with outcomes, and health care satisfaction. TOPS scoring ranges from 100, the worst possible score where pain impacts all components of the health domain, to 0, the best possible response where pain does not interfere with any component in the domain.|Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months|||units on TOPS scale||Standard Error|Mean
735950|NCT00432237|Secondary|Number of Patients Who Have Total Migraine Freedom 2 Hours Postdose|Pain Freedom and no migraine-associated symptoms at 2 hours postdose.|2 hours postdose|All randomized, treated patients who have at least one post-dose measurement at or prior to 2 hours.||Participants|||Number
735904|NCT00431847|Primary|Treatment Outcomes in Pain Survey (TOPS): Health Care Satisfaction|Treatment Outcomes in Pain Survey (TOPS): The 112-item TOPS explicitly acknowledges and measures contextual factors that are important in pain treatment including the dimensions of pain symptoms, fear avoidance, patient satisfaction with outcomes, and health care satisfaction. For the health care satisfaction scale of the TOPS, scoring ranges from 100, the best possible score where satisfaction is optimal, to 0, least satisfied.|Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months|||units on TOPS scale||Standard Error|Mean
735905|NCT00431847|Primary|Treatment Outcomes in Pain Survey (TOPS): Fear Avoidance|Treatment Outcomes in Pain Survey (TOPS): The 112-item TOPS explicitly acknowledges and measures contextual factors that are important in pain treatment including the dimensions of pain symptoms, fear avoidance, patient satisfaction with outcomes, and health care satisfaction. TOPS scoring ranges from 100, the worst possible score where pain impacts all components of the health domain, to 0, the best possible response where pain does not interfere with any component in the domain.|Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months|||units on TOPS scale||Standard Error|Mean
735906|NCT00431847|Primary|Post Traumatic Stress Disorder (PTSD) Total Severity|Post-Traumatic Stress Disorder Checklist (PCL): The PCL is a 17-item PTSD assessment instrument that asks respondents to rate the extent to which they have experienced each of the 17 diagnostic symptoms for PTSD outlined in the Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV). Scores are computed by adding the 17 items scored 1 to 5. Scores range from 17 to 85. Higher scores indicate higher severity of symptoms.|Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months|||units on the PCL scale||Standard Error|Mean
735907|NCT00431847|Primary|SF-36 Mental Component Summary|The Mental component score (MCS) is an aggregate of the eight subscale scores that account for measuring physical components with each subscale ranging from worst possible health, 0, to 100, the highest possible score and therefore the optimal health state. After the eight scale scores are calculated, a z-score is determined for each by subtracting the scale mean of a sample of the U.S. general population from an individual’s scale score and then dividing by the standard deviation from the U.S. general population. Each of the eight z-scores is then multiplied by the corresponding factor scoring coefficient for the scale. The products of the z-scores and factor scoring coefficients for the MCS are then summed together. Each resulting sum is multiplied by 10 and added to 50 to linearly transform the MCS to the T-score metric, which has a mean of 50 and a standard deviation of 10 for the U.S. general population (Taft et al., 2001) doi:10.1023/A:1012552211996|Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months|||t-score||Standard Error|Mean
735908|NCT00431847|Primary|SF-36 Physical Component Summary|The Physical component score (PCS) is an aggregate of the eight subscale scores measuring physical components with each subscale ranging from worst possible health, 0, to 100, the highest possible score and therefore the optimal health state. After the eight scale scores are calculated, a z-score is calculated for each by subtracting the scale mean of a sample of the U.S. general population from an individual’s scale score and then dividing by the standard deviation from the U.S. general population. Each of the eight z-scores is then multiplied by the corresponding factor scoring coefficient for the scale. The products of the z-scores and factor scoring coefficients for the PCS are then summed together. Each resulting sum is multiplied by 10 and added to 50 to linearly transform the PCS to the T-score metric, which has a mean of 50 and a standard deviation of 10 for the U.S. general population (Taft et al., 2001) doi:10.1023/A:1012552211996|Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months|||t-score||Standard Error|Mean
735909|NCT00431847|Primary|Brief Pain Inventory - Treatment Relief|The Brief Pain Inventory - Short form (BPI) is a 17-item self-report questionnaire designed to assess the severity of pain and the degree to which pain interferes with common dimensions of feeling and function. The BPI measures in the last 24 hours, how much relief pain treatments or medications provided on a scale of 0%, meaning no relief, to 100%, indicating complete relief.|Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months|||percentage of pain relief||Standard Error|Mean
735910|NCT00431847|Primary|Brief Pain Inventory - Pain Interference|"The Brief Pain Inventory - Short form (BPI) is a 17-item self-report questionnaire designed to assess severity of pain and the degree to which pain interferes with common dimensions of feeling and function. The BPI measures how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. BPI pain interference is scored as the mean of the seven interference items, each ranging 0 to 10, where 0 is pain from combat limb injury does not interfere and 10 is pain from combat limb injury completely interferes with this aspect of daily life."|Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months|||units on the Brief Pain Inventory Scale||Standard Error|Mean
735911|NCT00431847|Primary|Brief Pain Inventory - Average Pain|"The Brief Pain Inventory - Short form (BPI) is a 17-item self-report questionnaire designed to assess severity of pain and the degree to which pain interferes with common dimensions of feeling and function. BPI Item - Average Pain asks the respondent to rate combat limb injury pain on average (no time frame given) on a scale of 0 to 10, where 0 is no pain, and 10 is pain as bad as you can imagine."|Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months|||units on the Brief Pain Inventory Scale||Standard Error|Mean
735912|NCT00431847|Primary|Brief Pain Inventory - Worst Pain|"The Brief Pain Inventory - Short form (BPI) is a 17-item self-report questionnaire designed to assess severity of pain and the degree to which pain interferes with common dimensions of feeling and function. BPI Item - Worst Pain asks the respondent to rate worst pain in the past week from the combat limb injury on a scale of 0 to 10, where 0 is no pain, and 10 is pain as bad as you can imagine."|Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months|||units on the Brief Pain Inventory Scale||Standard Error|Mean
735913|NCT00431847|Primary|Neuropathic Pain Scale - Total Score|"The Neuropathic Pain Scale (NPS) is a 10-item self-report questionnaire designed to assess the distinct pain qualities associated with neuropathic pain, pain initiated or caused by a dysfunction of the nervous system. It has a scale of 0 - 10, where 0 is no pain and 10 is the most intense sensation imaginable. The NPS total score is an average of all ten items."|Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months|||units on the Neuropathic Pain Scale||Standard Error|Mean
735914|NCT00431847|Primary|Neuropathic Pain Scale - Overall Pain Quality|"The Neuropathic Pain Scale (NPS) is a 10-item self-report questionnaire designed to assess the distinct pain qualities associated with neuropathic pain, pain initiated or caused by a dysfunction of the nervous system. The NPS Overall Pain Quality composite score is a measure of six distinct pain qualities of respondents' combat limb pain on a scale of 0 - 10, where 0 is no pain and 10 is the most intense sensation imaginable. The six pain qualities included in the composite score is sharp, hot, dull, cold, itchy, and sensitive to touch."|Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months|||units on the Neuropathic Pain Scale||Standard Error|Mean
735915|NCT00431847|Primary|Neuropathic Pain Scale - Pain Intensity|"The Neuropathic Pain Scale (NPS) is a 10-item self-report questionnaire designed to assess the distinct pain qualities associated with neuropathic pain, pain initiated or caused by a dysfunction of the nervous system. Item numbers ask respondents to describe the intensity of their combat limb pain on a scale of 0 - 10, where 0 is no pain and 10 is the most intense pain imaginable."|Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months|||units on the Neuropathic Pain Scale||Standard Error|Mean
735916|NCT00431951|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: Ae(0-24)|Ae(0-24): Cumulative amount of drug excreted unchanged in urine over 24 hours (three 8-hour collection periods), determined on Days 1 and 21|Day 21|Post-screening, 30 healthy subjects were randomized into three active drug groups with 8 subjects each and one placebo group with 6 subjects. Between Days 6 and 21, there were 4 (out of 7 total) withdrawals due to inability to follow procedure (2; 250mg and placebo groups), lost to follow-up (1; 400mg group), and adverse event (1; 800mg group).||mg||Standard Deviation|Mean
735917|NCT00431951|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: Ae(0-24)|Ae(0-24): Cumulative amount of drug excreted unchanged in urine over 24 hours (three 8-hour collection periods), determined on Days 1 and 21|Day 1|Post-screening, 30 healthy subjects were randomized on Day 1 into three active drug groups with 8 subjects each and one placebo group with 6 subjects||mg||Standard Deviation|Mean
735918|NCT00431951|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: AUCtau|AUCtau: Area under the plasma concentration-time curve for each dosing interval (from time 0 to 24 hours sample) determined using the linear trapezoidal rule|Day 21|Post-screening, 30 healthy subjects were randomized into three active drug groups with 8 subjects each and one placebo group with 6 subjects. Between Days 6 and 21, there were 4 (out of 7 total) withdrawals due to inability to follow procedure (2; 250mg and placebo groups), lost to follow-up (1; 400mg group), and adverse event (1; 800mg group).||ng*hr/mL||Standard Deviation|Mean
735919|NCT00431951|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: AUCtau|AUCtau: Area under the plasma concentration-time curve for each dosing interval (from time 0 to 24 hours sample) determined using the linear trapezoidal rule|Day 6|Post-screening, 30 healthy subjects were randomized into three active drug groups with 8 subjects each and one placebo group with 6 subjects. By Day 6 there were 3 (out of 7 total) withdrawals from the study due to inability to follow procedure (2; 800mg and placebo groups), and requested due to concomitant medication (1; 400mg group)||ng*hr/mL||Standard Deviation|Mean
735920|NCT00431951|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: AUCtau|AUCtau: Area under the plasma concentration-time curve for each dosing interval (from time 0 to 24 hours sample) determined using the linear trapezoidal rule|Day 1|Post-screening, 30 healthy subjects were randomized on Day 1 into three active drug groups with 8 subjects each and one placebo group with 6 subjects||ng*hr/mL||Standard Deviation|Mean
735921|NCT00431951|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: t½|t½: Observed terminal elimination half-life determined after the last dose on Day 21|Day 21|Post-screening, 30 healthy subjects were randomized into three active drug groups with 8 subjects each and one placebo group with 6 subjects. Between Days 6 and 21, there were 4 (out of 7 total) withdrawals due to inability to follow procedure (2; 250mg and placebo groups), lost to follow-up (1; 400mg group), and adverse event (1; 800mg group).||hours||Standard Deviation|Mean
735922|NCT00431951|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: Tmax|Tmax: Time to reach maximum drug concentration in plasma calculated from [plasma] versus time profiles.|Day 21|Post-screening, 30 healthy subjects were randomized into three active drug groups with 8 subjects each and one placebo group with 6 subjects. Between Days 6 and 21, there were 4 (out of 7 total) withdrawals due to inability to follow procedure (2; 250mg and placebo groups), lost to follow-up (1; 400mg group), and adverse event (1; 800mg group)||hours||Standard Deviation|Mean
735923|NCT00431951|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: Tmax|Tmax: Time to reach maximum drug concentration in plasma calculated from [plasma] versus time profiles.|Day 6|Post-screening, 30 healthy subjects were randomized into three active drug groups with 8 subjects each and one placebo group with 6 subjects. By Day 6 there were 3 (out of 7 total) withdrawals from the study due to inability to follow procedure (2; 800mg and placebo groups), and requested due to concomitant medication (1; 400mg group)||hours||Standard Deviation|Mean
735924|NCT00431951|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: Tmax|Tmax: Time to reach maximum drug concentration in plasma calculated from [plasma] versus time profiles.|Day 1|Post-screening, 30 healthy subjects were randomized on Day 1 into three active drug groups with 8 subjects each and one placebo group with 6 subjects||hours||Standard Deviation|Mean
735925|NCT00431951|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: Cmax|Cmax: Maximum drug concentration in plasma determined directly from individual concentration-time data|Day 21|Post-screening, 30 healthy subjects were randomized into three active drug groups with 8 subjects each and one placebo group with 6 subjects. Between Days 6 and 21, there were 4 (out of 7 total) withdrawals due to inability to follow procedure (2; 250mg and placebo groups), lost to follow-up (1; 400mg group), and adverse event (1; 800mg group)||ng/mL||Standard Deviation|Mean
735926|NCT00431951|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: Cmax|Cmax: Maximum drug concentration in plasma determined directly from individual concentration-time data|Day 6|Post-screening, 30 healthy subjects were randomized into three active drug groups with 8 subjects each and one placebo group with 6 subjects. By Day 6 there were 3 (out of 7 total) withdrawals from the study due to inability to follow procedure (2; 800mg and placebo groups), and requested due to concomitant medication (1; 400mg group)||ng/mL||Standard Deviation|Mean
735927|NCT00431951|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: Cmax|Cmax: Maximum drug concentration in plasma determined directly from individual concentration-time data|Day 1|Post-screening, 30 healthy subjects were randomized on Day 1 into three active drug groups with 8 subjects each and one placebo group with 6 subjects||ng/mL||Standard Deviation|Mean
735928|NCT00431951|Primary|Number of Study Participants Who Tolerated ST-246 (250, 400 or 800mg) as Determined by Changes in Safety Parameters, According to the Division of Acquired Immunodeficiency Syndrome (DAIDS) Adverse Events (AE) Grading Table|"Evaluated safety parameters included:
physical examination/vital signs
electrocardiograms (heart rate, PR interval, QRS duration, QT interval, and QTc Bazett)
laboratory safety tests (hematology, chemistry, urinalysis)
adverse events (AEs) For a)-c), statistical values (mean, standard deviation, median, minimum, maximum) and changes from baseline (Day 1 pre-dose) to each time-point, were compared to laboratory normal reference ranges. If values for a)-d) were a Grade 3 or higher (in DAIDS AE Table)and ST-246-related, they were considered severe and significant, respectively."|Days 1, 6, 14-16, 21-24, 28-31, and 51-53|Post-screening, 30 healthy subjects were randomized into three active drug groups with 8 subjects each, and one placebo group with 6 subjects. A total of 7 withdrawals during the entire study were due to inability to follow procedure (4), lost to follow-up (1), requested due to concomitant medication (1), and an adverse event (1)||Participants|||Number
735929|NCT00431964|Primary|Change in FEV1 From Baseline to End of Treatment at Day 168||change from baseline to day 168|Modified intent to treat (randomized and at least one dose of study drug).||liters||Standard Deviation|Mean
736167|NCT00433160|Secondary|Back Pain Severity|Severity of back pain at baseline, individual visits and the last measurement point. Back pain was measured on a scale of 1 (none) to 4 (severe).|Baseline, Weeks 12, 24, 36, 52|Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.||participants|||Number
735951|NCT00432237|Secondary|Number of Patients Who Have Total Migraine Freedom 2 to 24 Hours Postdose|Pain Freedom and no migraine-associated symptoms at 2 hours postdose, with no administration of any rescue medication and no occurrence thereafter of a mild/moderate/severe headache or migraine-associated symptom during the 24 hours after dosing with study medication.|2 to 24 hours postdose|All randomized, treated patients who have at least one post-dose measurement at or prior to 2 hours and who either 1) did not have pain freedom at any time between 2 and 24 hours postdose, 2) used rescue medication between 2 and 24 hours postdose or 3) answered the 24 hour recurrence question (a question that ascertains recurrence of migraine pain)||Participants|||Number
735952|NCT00432237|Primary|Number of Patients Reporting Absence of Nausea at 2 Hours Post Dose|Respective experience (yes/no) of migraine-associated symptoms (including nausea) was recorded by the patient in a diary.|2 hours post dose|All randomized, treated patients who have at least one post-dose measurement at or prior to 2 hours.||Participants|||Number
735953|NCT00432237|Primary|Number of Patients Reporting Absence of Phonophobia at 2 Hours Post Dose|Respective experience (yes/no) of migraine-associated symptoms (including phonophobia) was recorded by the patient in a diary.|2 hours post dose|All randomized, treated patients who have at least one post-dose measurement at or prior to 2 hours.||Participants|||Number
735954|NCT00432237|Primary|Number of Patients Reporting Absence of Photophobia at 2 Hours Post Dose|Respective experience (yes/no) of migraine-associated symptoms (including photophobia) was recorded by the patient in a diary.|2 hours post dose|All randomized, treated patients who have at least one post-dose measurement at or prior to 2 hours.||Participants|||Number
735955|NCT00432237|Primary|Number of Patients Reporting Pain Relief at 2 Hours Post Dose|"Reduction of a Grade 2 or 3 severity migraine at baseline to mild or no pain (Grade 1 or 0) at 2 hours post dose.
Headache severity was recorded by the patient in a diary. 0=no pain; 1=mild pain; 2=moderate pain; 3=severe pain."|2 hours post dose|All randomized, treated patients who have at least one post-dose measurement at or prior to 2 hours.||Participants|||Number
735956|NCT00432237|Secondary|Number of Patients Who Have Sustained Pain-Freedom From 2 to 24 Hours Postdose|Pain Freedom at 2 hours postdose, with no administration of any rescue medication and no occurrence thereafter of a mild/moderate/severe headache during the 24 hours after dosing with study medication.|2 to 24 hours postdose|All randomized, treated patients who have at least one post-dose measurement at or prior to 2 hours and who either 1) did not have pain freedom at any time between 2 and 24 hours postdose, 2) used rescue medication between 2 and 24 hours postdose or 3) answered the 24 hour recurrence question (a question that ascertains recurrence of migraine pain)||Participants|||Number
735957|NCT00432237|Primary|Number of Patients Reporting Pain Freedom at 2 Hours Postdose|"Pain Freedom was defined as a reduction of a Grade 2 or 3 severity migraine at baseline to a no pain (Grade 0) at 2 hours post dose.
Headache severity was recorded by the patient in a diary. 0=no pain; 1=mild pain; 2=moderate pain; 3=severe pain."|2 hours post dose|All randomized, treated patients who have at least one post-dose measurement at or prior to 2 hours.||Participants|||Number
735958|NCT00432276|Secondary|Change From Baseline in Mean HDL Particle Size|Change from Baseline in mean HDL particle size was assessed by NMR lipid fractionation at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline mean HDL particle size as covariates.|Baseline and Weeks 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||nm||Standard Error|Least Squares Mean
735959|NCT00432276|Secondary|Change From Baseline in High Density Lipoprotein (HDL) Particles|The change from Baseline in levels of total, large, medium and small HDL particles was assessed by NMR fractionation at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline HDL particles as covariates.|Baseline and Weeks 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||μmol/L||Standard Error|Least Squares Mean
735960|NCT00432276|Secondary|Change From Baseline in Mean LDL Particle Size|Change from Baseline in mean LDL particle size was assessed by NMR lipid fractionation at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline mean LDL particle size as covariates.|Baseline and Weeks 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||nm||Standard Error|Least Squares Mean
735961|NCT00432276|Secondary|Change From Baseline in Low Density Lipoprotein (LDL) Particles|The change from Baseline in levels of total, large, medium-small, total small and very small LDL particles was assessed by NMR fractionation at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline LDL particles as covariates.|Baseline and Weeks 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||nmol/L||Standard Error|Least Squares Mean
735962|NCT00432276|Secondary|Change From Baseline in Intermediate Density Lipoprotein (IDL) Particles|The change from Baseline in levels of IDL particles was assessed by NMR lipid fractionation at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline IDL particles as covariates.|Baseline and Weeks 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||nmol/L||Standard Error|Least Squares Mean
735963|NCT00432276|Secondary|Change From Baseline in Mean VLDL Particle Size|Change from Baseline in mean VLDL particle size was assessed by NMR lipid fractionation at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline mean VLDL particle size as covariates.|Baseline and Weeks 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||nm||Standard Error|Least Squares Mean
736228|NCT00433446|Secondary|Overall Survival (OS)|Measured from date of registration to date of death due to any cause or last contact|0-3 yeas after registration|All eligible patients who started treatment were included in the analysis||months||95% Confidence Interval|Median
735964|NCT00432276|Secondary|Change From Baseline in VLDL Particles|The change from Baseline in levels of medium VLDL particles and small VLDL particles was assessed by NMR fractionation at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline VLDL particles as covariates.|Baseline and Weeks 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||nmol/L||Standard Error|Least Squares Mean
735965|NCT00432276|Secondary|Change From Baseline in VLDL / Chylomicron Triglycerides|"The change from Baseline in levels of VLDL/chylomicron triglycerides was assessed by NMR lipid fractionation at Weeks 12, 26, 42 and 52.
Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline VLDL/chylomicron triglycerides as covariates."|Baseline and Weeks 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
735966|NCT00432276|Secondary|Change From Baseline in Very Low Density Lipoprotein (VLDL) / Chylomicron Particles|"The change from Baseline in levels of total VLDL/chylomicron particles and large VLDL/chylomicron particles was assessed by NMR lipid fractionation at Weeks 12, 26, 42 and 52.
Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline VLDL/chylomicron particles as covariates."|Baseline and Weeks 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||nmol/L||Standard Error|Least Squares Mean
735967|NCT00432276|Secondary|Change From Baseline in Nuclear Magnetic Resonance Lipid Fractionation Total Triglycerides|Nuclear Magnetic Resonance (NMR) lipid fractionation was used to assess the change from Baseline in total triglyceride levels at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline NMR triglycerides as covariates.|Baseline and Weeks 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
735968|NCT00432276|Secondary|Change From Baseline in Adiponectin|Change from Baseline in adiponectin was assessed at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline adiponectin as covariates.|Baseline and Weeks 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||μg/mL||Standard Error|Least Squares Mean
735969|NCT00432276|Secondary|Change From Baseline in High-sensitivity C-Reactive Protein|Change from Baseline in high-sensitivity C-Reactive Protein (hsCRP) was assessed at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline hsCRP as covariates.|Baseline and Weeks 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||mg/L||Standard Error|Least Squares Mean
735970|NCT00432276|Secondary|Change From Baseline in Plasminogen Activator Inhibitor-1|Change from Baseline in plasminogen activator inhibitor-1 (PAI-1) was assessed at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline PAI-1 as covariates.|Baseline and Weeks 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||ng/ml||Standard Error|Least Squares Mean
735971|NCT00432276|Secondary|Change From Baseline in Apolipoprotein C-III|Change from Baseline in Apolipoprotein C-III was assessed at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein C-III as covariates.|Baseline and Weeks 12, 26, 42 and 52.|Full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
735972|NCT00432276|Secondary|Change From Baseline in Apolipoprotein B|Change from Baseline in Apolipoprotein B was assessed at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein B as covariates.|Baseline and Weeks 12, 26, 42 and 52.|Full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
735973|NCT00432276|Secondary|Change From Baseline in Apolipoprotein A2|Change from Baseline in Apolipoprotein A2 was assessed at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A2 as covariates.|Baseline and Weeks 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
735974|NCT00432276|Secondary|Change From Baseline in Apolipoprotein A1|Change from Baseline in Apolipoprotein A1 was assessed at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A1 as covariates.|Baseline and Weeks 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
735975|NCT00432276|Secondary|Change From Baseline in Free Fatty Acids|Change from Baseline in free fatty acids was assessed at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline free fatty acids as covariates.|Baseline and Weeks 12, 26, 42, and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||mmol/L||Standard Error|Least Squares Mean
736258|NCT00433771|Secondary|Time to Stent Occlusion|Time to stent occlusion(measured in days since stent placement) was recorded for any subjects who experienced occlusion.|Until 6 Months or death|Only 1 subject experienced stent occlusion during the study.||Days|||Number
735976|NCT00432276|Secondary|Change From Baseline in Triglycerides|Change from Baseline in triglycerides was assessed at Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline triglycerides as covariates.|Baseline and Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
735977|NCT00432276|Secondary|Change From Baseline in Low-Density Lipoprotein Cholesterol|Change from Baseline in low-density lipoprotein cholesterol (LDL-C) was assessed at Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline LDL cholesterol as covariates.|Baseline and Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
735978|NCT00432276|Secondary|Change From Baseline in High-Density Lipoprotein Cholesterol|Change from Baseline in high-density lipoprotein cholesterol (HDL-C) was assessed at Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline HDL cholesterol as covariates.|Baseline and Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
735979|NCT00432276|Secondary|Change From Baseline in Total Cholesterol|Change from Baseline in total cholesterol was assessed at Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline total cholesterol as covariates.|Baseline and Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
735980|NCT00432276|Secondary|Change From Baseline in Body Weight|Change from Baseline in body weight was assessed at Weeks 4, 8, 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline body weight as covariates.|Baseline and Weeks 4, 8, 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||kg||Standard Error|Least Squares Mean
735981|NCT00432276|Secondary|Change From Baseline in Calculated HOMA Beta-cell Function|"The Homeostasis Model Assessment (HOMA) estimates steady state beta cell function (%B) as a percentage of a normal reference population.
HOMA %B = 20 * insulin (µIU/mL) / fasting plasma glucose (mmol/L) - 3.5
The change from Baseline in the homeostasis model assessment of beta cell function was assessed at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline HOMA beta cell function as covariates."|Baseline and Weeks 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||percentage beta cell function||Standard Error|Least Squares Mean
735982|NCT00432276|Secondary|Change From Baseline in Calculated HOMA Insulin Resistance|"The Homeostasis Model Assessment of insulin resistance (HOMA IR) measures insulin resistance based on fasting glucose and insulin measurements:
HOMA IR = fasting plasma insulin (µIU/mL) * fasting plasma glucose (mmol/L) / 22.5
A higher number indicates a greater degree of insulin resistance. The change from Baseline in HOMA IR was assessed at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline HOMA insulin resistance as covariates."|Baseline and Weeks 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||insulin resistance||Standard Error|Least Squares Mean
735983|NCT00432276|Secondary|Change From Baseline in C-peptide|C-peptide is a byproduct created when the hormone insulin is produced and is measured by a blood test. Change from Baseline was assessed at Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline fasting C-peptide as covariates.|Baseline and Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||ng/mL||Standard Error|Least Squares Mean
735984|NCT00432276|Secondary|Change From Baseline in Proinsulin/Insulin Ratio|The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (μIU/mL) at weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52 relative to the Baseline value. Least squares means were from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline fasting proinsulin/insulin ratio as covariates.|Baseline and Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||ratio||Standard Error|Least Squares Mean
735985|NCT00432276|Secondary|Change From Baseline in Fasting Insulin|The change from Baseline in fasting insulin was assessed at Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52. Least Squares Means were from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline fasting insulin as covariates.|Baseline and Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||μIU/mL||Standard Error|Least Squares Mean
735986|NCT00432276|Secondary|Change From Baseline in Fasting Proinsulin|Proinsulin is a precursor to insulin, and was measured as an indicator of pancreatic function. The change from Baseline in fasting proinsulin was assessed at Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52. Least Squares Means were from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline fasting proinsulin as covariates.|Baseline and Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||pmol/L||Standard Error|Least Squares Mean
735987|NCT00432276|Secondary|Percentage of Participants Meeting Hyperglycemic Rescue Criteria|"Rescue was defined as meeting 1 of the following criteria, confirmed by a 2nd sample drawn within 7 days after the first sample and analyzed by the central laboratory:
After more than 2 weeks of treatment but prior to the Week 4 Visit: A single fasting plasma glucose (FPG) ≥275 mg/dL;
From the Week 4 Visit but prior to the Week 8 Visit: A single FPG ≥250 mg/dL;
From the Week 8 Visit but prior to the Week 12 Visit: A single FPG ≥225 mg/dL;
From the Week 12 Visit through the End-of-Treatment Visit: HbA1c ≥8.5% AND ≤0.5% reduction in HbA1c as compared with the baseline HbA1c."|Baseline to Week 52|Full Analysis Set including patients with a postbaseline visit.||percentage of participants|||Number
735988|NCT00432276|Secondary|Percentage of Participants With Marked Hyperglycemia|Marked Hyperglycemia is defined as fasting plasma glucose greater than or equal to 200 mg/dL (11.10 mmol/L).|Baseline to Week 52|Full Analysis Set including patients with at least one non-missing fasting plasma glucose result in each treatment group.||percentage of participants|||Number
735989|NCT00432276|Secondary|Change From Baseline in Fasting Plasma Glucose|The change from Baseline in fasting plasma glucose (FPG) was assessed at Weeks 2, 4, 8, 12, 16, 20, 26, 34, 42 and 52. Least Squares Means were from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline FPG as covariates.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 26, 34, 42 and 52.|The full analysis set, which included all randomized patients who received at least 1 dose of double-blind study drug and where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
735990|NCT00432276|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 2.0%|Clinical response at Weeks 26 and 52 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 2.0%.|Weeks 26 and 52.|The full analysis set. Patients who did not complete the scheduled Week 26 or Week 52 visit were assessed based on their response at the time of discontinuation.||percentage of participants|||Number
735991|NCT00432276|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 1.5%|Clinical response at Weeks 26 and 52 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 1.5%.|Weeks 26 and 52.|The full analysis set. Patients who did not complete the scheduled Week 26 or Week 52 visit were assessed based on their response at the time of discontinuation.||percentage of participants|||Number
735992|NCT00432276|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 1.0%|Clinical response at Weeks 26 and 52 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 1.0%.|Weeks 26 and 52.|The full analysis set. Patients who did not complete the scheduled Week 26 or Week 52 visit were assessed based on their response at the time of discontinuation.||percentage of participants|||Number
735993|NCT00432276|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 0.5%|Clinical response at Weeks 26 and 52 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 0.5%.|Weeks 26 and 52.|The full analysis set. Patients who did not complete the scheduled Week 26 or Week 52 visit were assessed based on their response at the time of discontinuation.||percentage of participants|||Number
735994|NCT00432276|Secondary|Percentage of Participants With Glycosylated Hemoglobin ≤ 7.5%|Clinical response at Weeks 26 and 52 was assessed by the percentage of participants with HbA1c less than or equal to 7.5%.|Weeks 26 and 52.|The full analysis set. Patients who did not complete the scheduled Week 26 or Week 52 visit were assessed based on their response at the time of discontinuation.||percentage of participants|||Number
735995|NCT00432276|Secondary|Percentage of Participants With Glycosylated Hemoglobin ≤ 7.0%|Clinical response at Weeks 26 and 52 was assessed by the percentage of participants with HbA1c less than or equal to 7%.|Weeks 26 and 52.|The full analysis set. Patients who did not complete the scheduled Week 26 or Week 52 visit were assessed based on their response at the time of discontinuation.||percentage of participants|||Number
735996|NCT00432276|Secondary|Percentage of Participants With Glycosylated Hemoglobin ≤ 6.5%|Clinical response at Weeks 26 and 52 was assessed by the percentage of participants with HbA1c less than or equal to 6.5%.|Weeks 26 and 52.|The full analysis set. Patients who did not complete the scheduled Week 26 or Week 52 visit were assessed based on their response at the time of discontinuation.||percentage of participants|||Number
735997|NCT00432276|Secondary|Change From Baseline in HbA1c Over Time|The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) during the study. Least Squares Means were from an Analysis of Covariance (ANCOVA) model with treatment, study schedule, and geographic region as class variables, and baseline metformin dose and baseline HbA1c as covariates.|Baseline and Weeks 4, 8, 12, 16, 20, 34 and 42.|Per-protocol set. Last observation carried forward (LOCF) imputation was utilized.||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
735998|NCT00432276|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|The change from Baseline to Week 26 and Week 52 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound).|Baseline and Weeks 26 and 52.|Per-protocol set included all randomized patients who received at least 1 dose of double-blind study medication and who had no major protocol violations. Last observation carried forward (LOCF) imputation was utilized.||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
735999|NCT00432341|Secondary|Patient Assessment of Need for Retreatment at Week 4|"Patients were queried regarding their need for another injection of botulinum toxin type A for cervical dystonia. Patients were required to answer How would you rate your need for another injection of botulinum toxin type A for cervical dystonia using the following scale?. The response options included 'absolutely requires injection', 'very much requires injection', 'somewhat requires injection', and 'does not require injection'."|Baseline, Week 4|Modified Intent to Treat: included all patients who were randomized to treatment, received treatment at Visit 1, and provided as least 1 post-dose assessment measure. Only completed assessments at the time points are included.||Number of Responses|||Number
736011|NCT00432380|Secondary|Number of Subjects Reporting RV in Gastroenteritis (GE) Episodes|Presence of RV (vaccine strain or wild-type) in GE stools.|From Dose 1 of study vaccine or placebo (at Day 0) up to Month 3|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine/placebo administration documented.||Subjects|||Number
736000|NCT00432341|Secondary|Patient Visual Analog Assessment of Pain at Week 4|Patients were required to assess their pain using a Visual Analog Scale in reference to their current perception of pain at that visit. This scale consisted of a line measuring 100 mm, and patients were instructed to put a mark on the line at the point that best described 'How much pain you are having right now'. Higher scores denoted higher pain intensity: 0 indicated 'No pain' and 100 indicated 'Worst possible pain'.|Baseline, Week 4|Modified Intent to Treat: included all patients who were randomized to treatment, received treatment at Visit 1, and provided as least 1 post-dose assessment measure.||Units on a Scale||Full Range|Median
736001|NCT00432341|Secondary|Patient Comparison of Benefit to Previous Injections at Week 20|"Patients assessed the improvement in cervical dystonia after receiving the study treatment compared to previous treatment(s). Patients were required to answer How would you rate the benefit of the current treatment of cervical dystonia with botulinum toxin type A compared to the previous treatment using the following scale?. The response options were 'much worse', 'worse', 'somewhat worse', 'same as previous', 'somewhat better', 'better', and 'much better'."|Week 20|Modified Intent to Treat: included all patients who were randomized to treatment, received treatment at Visit 1, and provided as least 1 post-dose assessment measure. Only completed assessments at this time point are included.||Number of Responses|||Number
736002|NCT00432341|Secondary|Physician Comparison of Benefit to Previous Injections at Week 20|"Physicians assessed the improvement in cervical dystonia after the study treatment compared to previous treatment(s) for each patient. Physicians were required to answer How would you rate the benefit of the current treatment of cervical dystonia with botulinum toxin type A compared to the previous treatment using the following scale?. The response options were 'much worse', 'worse', 'somewhat worse', 'same as previous', 'somewhat better', 'better', and 'much better'."|Week 20|Modified Intent to Treat: included all patients who were randomized to treatment, received treatment at Visit 1, and provided as least 1 post-dose assessment measure. Only completed assessments at this time point are included.||Number of Responses|||Number
736003|NCT00432341|Secondary|Physician Assessment of Cervical Dystonia Severity at Week 4|Physician assessment of cervical dystonia severity. The rating was assessed on a scale of 0 to 10, with higher scores denoting greater severity: 0 represented 'No evidence of dystonia' and 10 represented 'Worst cervical dystonia ever'|Baseline, Week 4|Modified Intent to Treat: included all patients who were randomized to treatment, received treatment at Visit 1, and provided as least 1 post-dose assessment measure.||Units on a Scale||Full Range|Median
736004|NCT00432341|Secondary|Global Assessment of Benefit by Physician at Week 4|Physician evaluation of benefit from botulinum toxin type A treatment for cervical dystonia. Ratings were on a scale of +4 to -4, with higher scores denoting improvement in cervical dystonia: +4 was 'Complete abolishment of signs and symptoms (about 100% improvement)', 0 represented 'Unchanged', and -4 represented 'Very marked worsening (about 100% worse or greater)'.|Week 4|Modified Intent to Treat: included all patients who were randomized to treatment, received treatment at Visit 1, and provided at least 1 post-dose assessment measure.||Units on a Scale||Full Range|Median
736005|NCT00432341|Secondary|Global Assessment of Benefit by Patient at Week 4|Patient evaluation of benefit from botulinum toxin type A treatment for cervical dystonia. Ratings were on a scale of +4 to -4, with higher scores denoting improvement in cervical dystonia: +4 was 'Complete abolishment of signs and symptoms (about 100% improvement)', 0 represented 'Unchanged', and -4 represented 'Very marked worsening (about 100% worse or greater)'.|Week 4|Modified Intent to Treat: included all patients who were randomized to treatment, received treatment at Visit 1, and provided at least 1 post-dose assessment measure.||Units on a Scale||Full Range|Median
736006|NCT00432341|Secondary|Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score at Week 4|The TWSTRS is an assessment scale used to measure the impact of cervical dystonia on patients. The score is comprised of 3 subscales: Severity, Disability, and Pain, each of which is scored independently. The total of these 3 comprises the TWSTRS total score which is scored from 0 (least symptoms) to 85 (worst symptoms). Higher scores indicate a greater degree of symptom severity.|Baseline, Week 4|Modified Intent to Treat: included all patients who were randomized to treatment, received treatment at Visit 1, and provided at least 1 post-dose assessment measure.||Scores on a Scale||Full Range|Median
736007|NCT00432341|Secondary|Toronto Western Spasmodic Torticollis Rating Scale Duration Target Score (TDTS) at Week 4|The TDTS was the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) score representing a loss of 80% of the treatment benefit at Week 4. The TDTS is calculated from the TWSTRS score and ranges from 0 (least symptoms) to 68 (worst symptoms). The TWSTRS total score which is scored from 0 (least symptoms) to 85 (worst symptoms).|Week 4|Modified Intent to Treat: included all patients who were randomized to treatment, received treatment at Visit 1, and provided at least 1 post-dose assessment measure.||Scores on a Scale||Full Range|Median
736008|NCT00432341|Primary|Duration of Treatment Benefit|Duration of treatment benefit was measured as the time (days) from Baseline until patients had a loss of therapeutic benefit, as defined by the achievement of their Toronto Western Spasmodic Torticollis Rating Scale Duration Target Score (TDTS) [loss of 80% of benefit].|20 Weeks|Modified Intent to Treat: included all patients who were randomized to treatment, received treatment at Visit 1, and provided at least 1 post-dose assessment measure.||Days||95% Confidence Interval|Median
736009|NCT00432380|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include any untoward medical occurrences that results in death, are life threatening, requires hospitalization or prolongation of hospitalization, result in disability/incapacity or congenital anomaly/birth defect in the offspring of a study subject.|During the entire study period (from Day 0 to Month 3)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine/placebo administration documented.||Subjects|||Number
736010|NCT00432380|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Event (AE)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.|During the 31-day (Days 0-30) period following any study vaccine dose or placebo|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine/placebo administration documented.||Subjects|||Number
736012|NCT00432380|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were cough/runny nose, diarrhea, fever (rectally), irritability, loss of appetite and vomiting. Any = any solicited symptom irrespective of intensity grade or relationship to vaccination. Grade 3 cough/runny nose = cough/runny nose which prevented daily activity. Grade 2 diarrhea: 4-5 looser than normal stools/ day. Grade 3 diarrhea = ≥ 6 looser than normal stools/ day. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 2 vomiting= 2 episodes of vomiting/ day. Grade 3 vomiting = ≥ 3 episodes of vomiting/ day. Related = symptom considered by the investigator to have a causal relationship to study vaccination.|During the 8-day (Days 0-7) period following each dose of study vaccine or placebo and across doses|The analysis was performed on the Total vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine/placebo administration documented.||Subjects|||Number
736013|NCT00432380|Secondary|Number of Subjects Reporting Grade 2 or Grade 3 Fever, Vomiting or Diarrhea|Any symptom = occurrence of the symptom (i.e. fever or vomiting or diarrhea) regardless of intensity grade or relationship to vaccination. Grade 2 fever = rectal temperature greater than (>) 38.5 – less than or equal to (≤) 39.5degrees Celsius (°C) or axillary temperature > 38.0 – ≤ 39.0°C. Grade 3 fever = rectal temperature > 39.5°C or axillary temperature > 39.0°C. Grade 2 vomiting = 2 episodes of vomiting/ day. Grade 3 vomiting = 3 or more episodes of vomiting/ day. Grade 2 diarrhea = 4-5 looser than normal stools/ day. Grade 3 diarrhea = 6 or more looser than normal stools/ day.|During the 8-day (Days 0-7) period following each dose of study vaccine or placebo and across doses|The analysis was performed on the Total vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine/placebo administration documented.||Subjects|||Number
736014|NCT00432380|Secondary|Serum IgA Antibody Concentrations Against Rotavirus|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in units per milliliter (U/mL). This outcome measure only concerns subjects in Placebo-Rotarix-Rotarix and Rotarix-Placebo-Rotarix Groups.|At Month 3|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who were seronegative for anti-RV IgA antibodies on the day of Dose 1 of Rotarix™ liquid vaccine or placebo and for whom immunogenicity data were available, at pre-sampling and post-sampling time points.||U/mL||95% Confidence Interval|Geometric Mean
736015|NCT00432380|Secondary|Number of Seroconverted Subjects for Anti-RV IgA Antibody|Seroconversion was defined as the appearance of anti-RV IgA antibody concentrations ≥ 20 U/mL in subjects initially (i.e. prior to the first dose of Rotarix™ vaccine or placebo) seronegative, when administered concomitantly with the first and third routine EPI immunization. This outcome measure only concerns subjects in the Rotarix-Placebo-Rotarix Group.|At Month 3|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who were seronegative for anti-RV IgA antibodies on the day of Dose 1 of Rotarix™ liquid vaccine or placebo and for whom immunogenicity data were available, at pre-sampling and post-sampling time points.||Subjects|||Number
736016|NCT00432380|Primary|Number of Seroconverted Subjects for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibody|Seroconversion was defined as the appearance of anti-RV IgA antibody concentrations greater than or equal to (≥) 20 units per milliliter (U/mL) in subjects initially (i.e. prior to the first dose of Rotarix™ vaccine or placebo) seronegative, when administered concomitantly with the second and third routine EPI immunization. This outcome measure only concerns subjects in the Placebo-Rotarix-Rotarix Group.|At Month 3|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all subjects who were seronegative for anti-RV IgA antibodies on the day of Dose 1 of Rotarix™ liquid vaccine or placebo and for whom immunogenicity data were available, at pre-sampling and post-sampling time points.||Subjects|||Number
736017|NCT00432445|Primary|Rate of Local Control in the Globe at 12 Months|Where proton beam radiation therapy used as an alternative to external photon beam irradiation in children with retinoblastoma as a means of local tumor control and ocular retention, local tumor control measured for participants with a globe as tumor regression with ocular retention, and for post enucleation measured as lack of orbital tumor recurrence.|12 months|No analysis performed. Study did not meet anticipated enrollment.|||||
736018|NCT00432458|Secondary|Number of Participants With Severe (Grade 3, 4 or 5) Adverse Events|"Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 2.
Description of Grades:
Grade 1: Mild Grade 2: Moderate Grade 3: Severe Grade 4: Life-threatening Grade 5: Death"|During treatment (up to 5 years)|||participants|||Number
736019|NCT00432458|Secondary|Time to Treatment Failure|Time to treatment failure (TTF) was defined as the time from randomization to the date at which the patient was removed from (protocol) treatment due to disease progression, unacceptable toxicity, participant refusal or death. The median TTF with 95% CI was estimated using the Kaplan Meier method|time from randomization to treatment failure (up to 5 years)|||months||95% Confidence Interval|Median
736020|NCT00432458|Secondary|Time to Subsequent Treatment|Time to subsequent treatment (TTS) was defined as time from end of active (protocol) treatment to the start of subsequent treatment for participants with progressive disease. The median TTS with 95% CI was estimated using the Kaplan Meier method|time from end of treatment to subsequent treatment (up to 5 years)|This data was not (and will never be) analyzed as it was not submitted consistently across all participants.||years||95% Confidence Interval|Median
736021|NCT00432458|Secondary|Duration of Response (Complete Response, Partial Response, and Very Good Partial Response)|Duration of response (DOR) is defined as the time from first documentation of response (CR, VGPR or PR) to disease progression. The median DOR with 95% CI was estimated using the Kaplan Meier method|time from start of response to progression (up to 5 years)|Participants who achieved a confirmed response (CR, VGPR, or PR) as described above were analyzed.||years||95% Confidence Interval|Median
736022|NCT00432458|Secondary|Number of Participants With a Confirmed Response (Complete Response [CR], Very Good Partial Response [VGPR] or Partial Response [PR]) on Two Consecutive Evaluations at Least 2 Weeks Apart in the First 12 Months of Treatment|"Response is defined as follows:
CR: Complete disappearance of M-protein from serum & urine on immunofixation, <5% plasma cells in bone marrow (BM)
VGPR: >=90% reduction in serum M-component; Urine M-Component <100 mg per 24 hours; <=5% plasma cells in BM
PR: >= 50% reduction in serum M-Component and/or Urine M-Component >= 90% reduction or <200 mg per 24 hours; or >= 50% decrease in difference between involved and uninvolved FLC levels"|12 months|||participants|||Number
736024|NCT00432458|Primary|Time to Disease Progression (TTP)|Time to disease progression (TTP) was defined as the time from randomization to the earliest documentation of disease progression. Participants were followed for a maximum of 5 years from registration. The median OS with 95% CI was estimated using the Kaplan Meier method, a two-sided (stratified) log-rank test was calculated.|randomization to progression (up to 5 years)|Time to disease progression was analyzed on all randomized participants on an intent to treat basis.||years||95% Confidence Interval|Median
736025|NCT00432562|Primary|Mean Residence Time (MRTinf)|MRT = (AUMCinf)/(AUCinf)|0-144 hours post-dose|||hours||Standard Deviation|Mean
736026|NCT00432562|Primary|Last Quantifiable Drug Concentration (Clast)||0-144 hours post-dose|||ng/mL||Standard Deviation|Mean
736027|NCT00432562|Primary|Time of Last Measurable Concentration (Tlast)||0-144 hours post-dose|||hours||Standard Deviation|Mean
736028|NCT00432562|Primary|Observed Terminal Elimination Half-Life (t1/2)|t1/2 = [ln(2)/λ z]|0-144 hours post-dose|||hours||Standard Deviation|Mean
736029|NCT00432562|Primary|Observed Elimination Rate Constant Associated With the Terminal Portion of the Curve (λ z)|Estimated via linear regression of the time versus log concentration|0-144 hours post-dose|||hr-1||Standard Deviation|Mean
736030|NCT00432562|Primary|Percentage of AUCinf Based on Extrapolation (AUCextrap)||0-144 hours post-dose|||% of participants||Standard Deviation|Mean
736031|NCT00432562|Primary|Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf)|AUCinf = AUClast + (Clast/lamda z)|0-144 hours post-dose|||hr*ng/mL||Standard Deviation|Mean
736032|NCT00432562|Primary|Area Under the Plasma Concentratio-Time Curve From Time 0 to the Time of the Last Measurable Concentration (AUClast)|Determined Using the Linear Trapezoidal Rule|0-144 hours post-dose|||hr*ng/mL||Standard Deviation|Mean
736033|NCT00432562|Primary|Maximum Observed Plasma Concentration (Cmax)||0-144 hours post-dose|||ng/mL||Standard Deviation|Mean
736034|NCT00432562|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0-144 hours post dose|||hours||Standard Deviation|Mean
736035|NCT00432601|Primary|Knowledge|Questions addressed the survival benefit and side effects associated with treatment options for localized prostate cancer.|Results visit (Time 2 - approximately 7-10 days after Time 1)|||percentage correct on a 12 item scale||Standard Error|Mean
736036|NCT00432666|Secondary|"Change From Baseline to Final Visit in the Carer Burden Scale for Domain Applying a Splint on the Affected Arm"|The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).|Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change||Participants|||Number
736037|NCT00432666|Secondary|"Change From Baseline to Week 12 in the Carer Burden Scale for Domain Applying a Splint on the Affected Arm"|The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).|Baseline, Week 12|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change||Participants|||Number
736038|NCT00432666|Secondary|"Change From Baseline to Week 4 in the Carer Burden Scale for Domain Applying a Splint on the Affected Arm"|The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).|Baseline, Week 4|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change||Participants|||Number
736039|NCT00432666|Secondary|"Change From Baseline to Final Visit in the Carer Burden Scale for Domain Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket)"|The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).|Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change||Participants|||Number
736040|NCT00432666|Secondary|"Change From Baseline to Week 12 in the Carer Burden Scale for Domain Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket)"|The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).|Baseline, Week 12|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change||Participants|||Number
736041|NCT00432666|Secondary|"Change From Baseline to Week 4 in the Carer Burden Scale for Domain Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket)"|The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).|Baseline, Week 4|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change||Participants|||Number
736042|NCT00432666|Secondary|"Change From Baseline to Final Visit in the Carer Burden Scale for Domain Cleaning the Armpit of the Affected Arm"|The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).|Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change||Participants|||Number
736043|NCT00432666|Secondary|"Change From Baseline to Week 12 in the Carer Burden Scale for Domain Cleaning the Armpit of the Affected Arm"|The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).|Baseline, Week 12|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change||Participants|||Number
736044|NCT00432666|Secondary|"Change From Baseline to Week 4 in the Carer Burden Scale for Domain Cleaning the Armpit of the Affected Arm"|The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).|Baseline, Week 4|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change||Participants|||Number
736045|NCT00432666|Secondary|"Change From Baseline to Final Visit in the Carer Burden Scale for Domain Cutting the Fingernails of the Affected Hand"|The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).|Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change||Participants|||Number
736046|NCT00432666|Secondary|"Change From Baseline to Week 12 in the Carer Burden Scale for Domain Cutting the Fingernails of the Affected Hand"|The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).|Baseline, Week 12|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change||Participants|||Number
736047|NCT00432666|Secondary|"Change From Baseline to Week 4 in the Carer Burden Scale for Domain Cutting the Fingernails of the Affected Hand"|The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).|Baseline, Week 4|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change||Participants|||Number
736048|NCT00432666|Secondary|"Change From Baseline to Final Visit in the Carer Burden Scale for Domain Cleaning the Palm of the Affected Hand"|The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).|Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change||Participants|||Number
736049|NCT00432666|Secondary|"Change From Baseline to Week 12 in the Carer Burden Scale for Domain Cleaning the Palm of the Affected Hand"|The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).|Baseline, Week 12|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change||Participants|||Number
736050|NCT00432666|Secondary|"Change From Baseline to Week 4 in the Carer Burden Scale for Domain Cleaning the Palm of the Affected Hand"|The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).|Baseline, Week 4|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change||Participants|||Number
737667|NCT00454142|Secondary|Pharmacokinetic Study: AUC0-24h/Dose on Day 1|AUC 0-24h/dose were measured on day 1 for 26 evaluable participants. Blood sampling is done at zero (pre-dose), 0.5 hr, 1, 2, 3, 4, 5, 6 and 8 hrs after the first dose.|Day 1 of treatment|||hr*ng/mL/mg||Full Range|Median
736051|NCT00432666|Secondary|"Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Pain"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
736052|NCT00432666|Secondary|"Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Pain"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 12|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
736053|NCT00432666|Secondary|"Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Pain"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 8|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
736054|NCT00432666|Secondary|"Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Pain"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 4|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
736055|NCT00432666|Secondary|"Change From Baseline to Week 2 in the Disability Assessment Scale for Domain Pain"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 2|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
736056|NCT00432666|Secondary|"Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Limb Position"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
736057|NCT00432666|Secondary|"Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Limb Position"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 12|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
736058|NCT00432666|Secondary|"Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Limb Position"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 8|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
736059|NCT00432666|Secondary|"Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Limb Position"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 4|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
736060|NCT00432666|Secondary|"Change From Baseline to Week 2 in the Disability Assessment Scale for Domain Limb Position"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 2|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
736061|NCT00432666|Secondary|"Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Dressing"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
736062|NCT00432666|Secondary|"Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Dressing"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 12|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
736063|NCT00432666|Secondary|"Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Dressing"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 8|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
736064|NCT00432666|Secondary|"Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Dressing"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 4|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
736065|NCT00432666|Secondary|"Change From Baseline to Week 2 in the Disability Assessment Scale for Domain Dressing"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 2|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
736066|NCT00432666|Secondary|"Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Hygiene"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
736067|NCT00432666|Secondary|"Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Hygiene"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 12|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
736068|NCT00432666|Secondary|"Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Hygiene"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 8|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
736069|NCT00432666|Secondary|"Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Hygiene"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 4|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
736070|NCT00432666|Secondary|"Change From Baseline to Week 2 in the Disability Assessment Scale for Domain Hygiene"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 2|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
736071|NCT00432666|Secondary|Change From Baseline to Final Visit in the Disability Assessment Scale for the Principal Therapeutic Target|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
736072|NCT00432666|Secondary|Change From Baseline to Week 12 in the Disability Assessment Scale for the Principal Therapeutic Target|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 12|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
736073|NCT00432666|Secondary|Change From Baseline to Week 8 in the Disability Assessment Scale for the Principal Therapeutic Target|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 8|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
736074|NCT00432666|Secondary|Change From Baseline to Week 4 in the Disability Assessment Scale for the Principal Therapeutic Target|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 4|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
736075|NCT00432666|Secondary|Change From Baseline to Week 2 in the Disability Assessment Scale for the Principal Therapeutic Target|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 2|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
736076|NCT00432666|Secondary|Carer's Global Assessment of Efficacy|The Carer's Global Assessment of Efficacy is a subjective estimation assessed on a 4-point Likert scale with the items 1=very good, 2=good, 3=moderate, and 4=poor.|Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
736077|NCT00432666|Secondary|Patient's Global Assessment of Efficacy|The Patient's Global Assessment of Efficacy is a subjective estimation assessed on a 4-point Likert scale with the items 1=very good, 2=good, 3=moderate, and 4=poor.|Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
736078|NCT00432666|Secondary|Investigator's Global Assessment of Efficacy|The Investigator's Global Assessment of Efficacy is a subjective estimation assessed on a 4-point Likert scale with the items 1=very good, 2=good, 3=moderate, and 4=poor.|Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
736079|NCT00432666|Other Pre-specified|Onset of Treatment Effect [Classified]|"Starting with the visit 2 weeks after baseline injection the subject was asked if he/she experienced an treatment effect and if yes: when. If the subject did not experience an treatment effect he/she was asked again at each of the following visits (at week 4, 8, and 12) of the Main Period until the answer was yes or until the final visit of the Main Period was performed.
For subjects without any treatment effect the time to onset of effect was censored at the last visit of the Main Period."|Period starting at baseline injection of the Main Period up to onset of treatment effect|"These results are a different presentation of the results of the secondary outcome measure Time to Onset of Treatment Effect. For subjects without any treatment effect the time to onset of effect was censored at the last visit."||Participants|||Number
736273|NCT00433836|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP)|Mean sitting systolic blood pressure (MSSBP) change after 12 weeks of treatment measured by office blood pressure measurement.|Baseline and Week 12|Intent-to-treat. Only patients who had both baseline and endpoint values are included.||mm Hg||Standard Error|Least Squares Mean
736080|NCT00432666|Secondary|Duration of Treatment Effect|The duration of treatment effect is defined as the time period from the day of injection until the time point of a need for a new injection agreed by the patient and the investigator. For subjects without any treatment effect the duration of effect was set to zero.|Period from the day of injection until the time point of a need for a new injection agreed by the patient and the investigator|||Days||95% Confidence Interval|Median
736081|NCT00432666|Secondary|Time to Waning of Treatment Effect|Subject who reported an onset of treatment effect were asked at each visit/telephone contact starting at week 4 at earliest if he/she felt that there was a waning of the treatment effect. The same question was asked at each of the following telephone contacts and visits (up to the Final Visit of the Main Period) if the answer at the respective previous visit was “no”. If the patient answered with “yes” he/she will be asked at which week after the injection (= the time span in weeks) the waning of effect occurred. For all subjects without an onset of treatment effect the waning was set to zero.|Defined as time (weeks) from Visit 2 (injection session at Baseline, Day 0) to the subjective estimation of the waning of the effect|||Weeks||95% Confidence Interval|Median
736082|NCT00432666|Secondary|Time to Onset of Treatment Effect|"Starting with the visit 2 weeks after baseline injection the subject was asked if he/she experienced an treatment effect and if yes: when. If the subject did not experience an treatment effect he/she was asked again at each of the following visits (at week 4, 8, and 12) of the Main Period until the answer was yes or until the final visit of the Main Period was performed.
For subjects without any treatment effect the time to onset of effect was censored at the last visit of the Main Period."|Period starting at Visit 2 (baseline injection) of the Main Period up to onset of treatment effect|"Results for placebo patients were not displayed because the upper limit of the confidence interval was not estimable (this can not be entered because a numeric entry is expected). The results of this analysis are therefore given as Onset of Treatment Effect [classified] under Other Pre-specified Outcome."||Days||95% Confidence Interval|Median
736083|NCT00432666|Secondary|Change From Baseline to Final Visit in Ashworth Scale Score for Treated Thumb Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
736084|NCT00432666|Secondary|Change From Baseline to Week 12 in Ashworth Scale Score for Treated Thumb Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 12|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
736085|NCT00432666|Secondary|Change From Baseline to Week 8 in Ashworth Scale Score for Treated Thumb Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 8|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
736086|NCT00432666|Secondary|Change From Baseline to Week 4 in Ashworth Scale Score for Treated Thumb Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 4|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
736087|NCT00432666|Secondary|Change From Baseline to Week 2 in Ashworth Scale Score for Treated Thumb Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 2|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
736088|NCT00432666|Secondary|Change From Baseline to Final Visit in Ashworth Scale Score for Finger Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
736089|NCT00432666|Secondary|Change From Baseline to Week 12 in Ashworth Scale Score for Finger Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 12|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
736274|NCT00440232|Secondary|Time to Development of Headache of Any Intensity|Time to development of headache of any intensity in the 2 treatment arms|20 hours|||hours||95% Confidence Interval|Mean
736090|NCT00432666|Secondary|Change From Baseline to Week 8 in Ashworth Scale Score for Finger Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 8|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
736091|NCT00432666|Secondary|Change From Baseline to Week 4 in Ashworth Scale Score for Finger Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 4|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
736092|NCT00432666|Secondary|Change From Baseline to Week 2 in Ashworth Scale Score for Finger Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 2|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
736093|NCT00432666|Secondary|Change From Baseline to Final Visit in Ashworth Scale Score for Wrist Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
736094|NCT00432666|Secondary|Change From Baseline to Week 12 in Ashworth Scale Score for Wrist Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 12|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
736095|NCT00432666|Secondary|Change From Baseline to Week 8 in Ashworth Scale Score for Wrist Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 8|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
736096|NCT00432666|Secondary|Change From Baseline to Week 4 in Ashworth Scale Score for Wrist Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 4|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
736097|NCT00432666|Secondary|Change From Baseline to Week 2 in Ashworth Scale Score for Wrist Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 2|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
736098|NCT00432666|Secondary|Change From Baseline to Final Visit in Ashworth Scale Score for Treated Forearm Pronators|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
736099|NCT00432666|Secondary|Change From Baseline to Week 12 in Ashworth Scale Score for Treated Forearm Pronators|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 12|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
736130|NCT00432809|Secondary|Change in Systolic Blood Pressure (SBP)|Change in Systolic Blood Pressure (SBP) at 12 months|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.||mm Hg||Standard Deviation|Mean
736100|NCT00432666|Secondary|Change From Baseline to Week 8 in Ashworth Scale Score for Treated Forearm Pronators|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 8|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
736101|NCT00432666|Secondary|Change From Baseline to Week 4 in Ashworth Scale Score for Treated Forearm Pronators|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 4|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
736102|NCT00432666|Secondary|Change From Baseline to Week 2 in Ashworth Scale Score for Treated Forearm Pronators|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 2|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
736103|NCT00432666|Secondary|Change From Baseline to Final Visit in Ashworth Scale Score for Treated Elbow Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
736104|NCT00432666|Secondary|Change From Baseline to Week 12 in Ashworth Scale Score for Treated Elbow Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 12|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
736105|NCT00432666|Secondary|Change From Baseline to Week 8 in Ashworth Scale Score for Treated Elbow Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 8|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
736106|NCT00432666|Secondary|Change From Baseline to Week 4 in Ashworth Scale Score for Treated Elbow Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 4|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
736107|NCT00432666|Secondary|Change From Baseline to Week 2 in Ashworth Scale Score for Treated Elbow Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 2|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
736108|NCT00432666|Secondary|Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Thumb Flexors at All Post Baseline Visits|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 2, Week 4, Week 8, Week 12, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by worst case, i.e. zero change||Participants|||Number
736109|NCT00432666|Secondary|Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Finger Flexors at All Post Baseline Visits|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 2, Week 4, Week 8, Week 12, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by worst case, i.e. zero change||Participants|||Number
736110|NCT00432666|Secondary|Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Forearm Pronators at All Post Baseline Visits|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 2, Week 4, Week 8, Week 12, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by worst case, i.e. zero change||Participants|||Number
736111|NCT00432666|Secondary|Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Elbow Flexors at All Post Baseline Visits|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 2, Week 4, Week 8, Week 12, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by worst case, i.e. zero change||Participants|||Number
736112|NCT00432666|Secondary|Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Wrist Flexors at All Other Post Baseline Visits|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 2, Week 8, Week 12, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by worst case, i.e. zero change||Participants|||Number
736113|NCT00432666|Secondary|Responders at Week 4 Based on a Responder Definition of at Least 2 Points Improvement From Baseline in the Ashworth Score for Wrist Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 4|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by worst case, i.e. zero change||Participants|||Number
736114|NCT00432666|Primary|Number of Participants With Reduction of at Least 1 Point at Week 4 Compared to Baseline in Ashworth Score in Wrist Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 4|Intention to treat (ITT) as defined as all randomized subjects; missing values were not imputed||Participants|||Number
736115|NCT00432744|Primary|Non-parametric Hotelling T-square Bivariate Analysis of GMGF 88 and OPeds QOL.|This is a multivariate analysis of the first two outcomes: Period 2 minus Period 1 GMFM88 and Peds Quality of Life, analyzed as follows: First, to be in the analysis, subjects must contribute at least one of these endpoints. Second, if the subject became totally disabled during period 1, the difference was defined as + infinity, (highest possible evidence favoring period 2), and if the subject became totally disabled in period 2, the subject was scored as - infinity (highest possible evidence favoring period 1). Period 2 minus period 1 differences were ranked form low to high with missing values scores at the mid-rank. The Hotelling T-square was computed on these ranks and the P-value was obtained from 100,000 rerandomizations as the fraction of rerandomizations with T-sq at least as large as that observed.|end of 12 month minus end of 6 month difference.|Subjects contributes at least one difference (either GMFM or Peds QOL). Thirteen contributed both and one each was missing GMFM or Peds QOL.||participants|||Number
736116|NCT00432744|Primary|Pediatric Quality of Life Scale|"The Pediatric Quality of Life Scale is a validated scale ranging from 0 to 100 (the higher the better). Since there was the possibility of a subject becoming totally disabled our FDA peer reviewed design called for its use as follows: If the subject completed both periods, the score was calculated as the difference in scores between the end of Period 2 (at 12 months) minus that at the end of Period 1 (6 months). If a subject became totally disabled, this difference was considered as plus infinity if it occurred in period 1 (Penalizes period 1), and minus infinity if it occurred in Period 2 (Penalizes period 2). The two treatments were compared via the Wilcoxon test, and the effect size was estimated using Kendall's Tau-B. This is interpreted in a similar manner to correlation with positive values favoring COQenzyme10 and negative values favoring placebo. Goggle pedsQL and Mapi to browse the copyrighted manual. A link to the instrument is included."|At 6 and 12 Months|7 subjects in each group were evaluable for this endpoint. The two subjects who became disabled are evaluable. One subject did not have period 2 Quality of Life data and is excluded.||units on a scale||Inter-Quartile Range|Median
736131|NCT00432809|Secondary|Change in Body Mass Index (BMI)|Change in Body Mass Index (BMI) at 12 months, measured in kg/m2|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.||kg/m2||Standard Deviation|Mean
736275|NCT00440232|Primary|Incidence of Fasting-induced Headache of Any Intensity|Incidence of fasting-induced headache of any intensity occurring at greater than 4 hours, but within 20 hours after onset of fasting|20 hours|||participants|||Number
736117|NCT00432744|Primary|McMaster Gross Motor Function (GMFM 88)|The McMaster Gross Motor Function is a validated scale ranging from 0 to 100 (the higher the better). Since there was the possibility of a subject becoming totally disabled our FDA peer reviewed design called for its use as follows: If the subject completed both periods, the score was calculated as the difference in scores between the end of Period 2 (at 12 months) minus that at the end of Period 1 (6 months). If a subject became totally disabled, this difference was considered as plus infinity if it occurred in period 1 (Penalizes period 1), and minus infinity if it occurred in Period 2 (Penalizes period 2). The two treatments were compared via the Wilcoxon test, and the effect size was estimated using Kendall's Tau-B. This is interpreted in a similar manner to correlation with positive values favoring COQenzyme10 and negative values favoring placebo. One of the links in this report is to the the GMFM scale and how it is scored. A link to the instrument is included.|Taken at 6 and 12 Months|||units on a scale||Inter-Quartile Range|Median
736118|NCT00432809|Secondary|Cardiovascular Medications - Anticoagulants|Number of participants taking anticoagulants at 12 months|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.||participants|||Number
736119|NCT00432809|Secondary|Cardiovascular Medications - Angiotensin-converting Enzyme (ACE Inhibitor) or Angiotensin-receptor Blocker (ARB)|Number of participants taking Angiotensin-converting enzyme (ACE Inhibitor) or Angiotensin-receptor blocker (ARB) at 12 months|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.||participants|||Number
736120|NCT00432809|Secondary|Cardiovascular Medications - Beta Blocker|Number of participants taking Beta Blockers at 12 months|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.||participants|||Number
736121|NCT00432809|Secondary|Cardiovascular Medications - Lipid Lowering Agents|Number of participants taking Lipid lowering agents at 12 months|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.||participants|||Number
736122|NCT00432809|Secondary|Diabetes Medication - Use of Secretagogue|Number of participants taking Secretagogues at 12 months|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.||participants|||Number
736123|NCT00432809|Secondary|Diabetes Medication - Use of Incretin Mimetics|Number of participants taking Incretin Mimetics|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.||participants|||Number
736124|NCT00432809|Secondary|Diabetes Medication - Use of Thiazolidinedione|Number of participants using thiazolidinedione at 12 months|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.||participants|||Number
736125|NCT00432809|Secondary|Diabetes Medication - Use of Biguanides|Number of participants taking Biguanides at 12 months|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.||participants|||Number
736126|NCT00432809|Secondary|Diabetes Medication - Use of Insulin|Number of participants taking insulin at 12 months|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.||participants|||Number
736127|NCT00432809|Secondary|Change in High-sensitivity C-reactive Protein (Hs-CRP)|Median percent change in high-sensitivity C-reactive protein (hs-CRP)from baseline at 12 months|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.||mg/L||Inter-Quartile Range|Median
736128|NCT00432809|Secondary|Change in Triglycerides|Median percent change in triglycerides at 12 months from baseline measure|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.||mg/dL||Inter-Quartile Range|Median
736129|NCT00432809|Secondary|Change in High-density Lipoprotein (HDL)|Percent change in high-density lipoprotein (HDL) at 12 months|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.||mg/dL||Standard Deviation|Mean
736151|NCT00433004|Primary|ABILITY TO FOLLOW POSTPARTUM TEENS FOR 1 YEAR.||1 year|||Participants|||Count of Participants
736276|NCT00440271|Secondary|Post-dose TPV and RTV Concentrations at Week 4||Week 4||||||
736132|NCT00432809|Secondary|Body Mass Index (BMI)|Body Mass Index (BMI) at 12 months measured as kg/m2|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.||kg/m2||Standard Deviation|Mean
736133|NCT00432809|Secondary|Change in Body Weight From Baseline|Mean change in body weight from baseline measured in kilograms (kg)|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.||kg||Standard Deviation|Mean
736134|NCT00432809|Secondary|Body Weight|Body weight in kilograms (kg) measured at 12 months|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.||kg||Standard Deviation|Mean
736135|NCT00432809|Primary|Success Rate of Biochemical Resolution of Diabetes at 12 Months as Measured by HbA1c ≤ 6% With no Diabetes Medications|The proportion of subjects with a glycated hemoglobin level of 6% or less(without diabetes medications) 12 months after randomization.|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.||participants|||Number
736136|NCT00432809|Secondary|Glycated Hemoglobin (HbA1c)|Mean glycated hemoglobin (HbA1c) at 12 months for each of the 3 groups, in percentage points|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.||percentage points of glycated hemoglobin||Standard Deviation|Mean
736137|NCT00432809|Secondary|Fasting Plasma Glucose|Fasting Plasma Glucose measured in mg/dL.|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.||mg/dL||Inter-Quartile Range|Median
736138|NCT00432809|Secondary|Change in Glycated Hemoglobin (HbA1c)|Change in glycated hemoglobin(HbA1c)from baseline in percentage points / percent change|1 year - baseline|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.||percentage points of glycated hemoglobin||Standard Deviation|Mean
736139|NCT00432809|Secondary|The Cost-effectiveness of Each Program and the Side Effects and /or Complications.||1, 2, and 5 years.||||||
736140|NCT00432809|Secondary|Changes in Obesity-related Comorbidities (Blood Pressure, Dyslipidemia), Quality of Life, and Hospitalizations.||1, 2, and 5 years||||||
736141|NCT00432809|Secondary|Changes in Specific Metabolic Parameters (Insulin Secretion and Resistance).||1, 2, and 5 years||||||
736142|NCT00432809|Primary|Success Rate of Biochemical Resolution of Diabetes at 12 Months as Measured by HbA1c ≤ 6%.|The proportion of subjects with a glycated hemoglobin level of 6% or less(with or without diabetes medications) 12 months after randomization (baseline measure).|1 year|Modified intent-to-treat (ITT) population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.||participants|||Number
736143|NCT00432835|Primary|Symptom of Gastric Emptying Time (GET) Associated With Gastroparesis|Transit time of a radio-labeled meal through the stomach, measured by scintigraphy for %contents remaining in the stomach at 1 hour, 2 hours, and 4 hours. GET measures were obtained at baseline, during the period allowed for 'washout', and on the final study day.|Study Day 0 (Baseline), Day 4, Day 8|||percentage of radiolabeled meal in stoma||Standard Error|Mean
736144|NCT00432835|Primary|Symptom of Nausea Associated With Gastroparesis|Likert Scale 0-4 (low-high) using a patient reported outcomes tool|Study Day 0 (Baseline), Day 3, Day 7|||Patient Self-reported Symptom Score||Standard Error|Mean
736145|NCT00432835|Primary|Symptom of Vomiting Associated With Gastroparesis|Likert Scale 0-4 (low-high) using a patient reported outcomes tool|Study Day 0 (Baseline), Day 3, Day 7|||Patient Self-reported Symptom Score||Standard Error|Mean
736146|NCT00432991|Primary|Post-Operation Nausea Score|"Subjects were asked to rate their nausea level on a scale of 0-3, where 0=no nausea, 1=mild nausea, 2=moderate nausea, and 3=severe nausea two times after the conclusion of their surgery: 1) upon arrival in the PACU, and 2) immediately prior to discharge from the PACU.
The numbers given by the subject were then averaged to determine the average level of nausea post-operative for each subject."|post-operation|||units on a scale||Standard Deviation|Mean
736147|NCT00432991|Primary|Subject's Self-rated Intra-operative Nausea Level on a Scale of 0-3, Where 0=no Nausea, 1=Mild Nausea, 2=Moderate Nausea, and 3=Severe Nausea.|"Subjects were asked to rate their nausea level on a scale of 0-3, where 0=no nausea, 1=mild nausea, 2=moderate nausea, and 3=severe nausea, five times during their procedure: 1) Immediately prior to skin incision, 2) immediately following delivery of the baby, 3) following reinternalization of the uterus, 4) following closure of the fascia, 5) following closure of the skin.
The numbers given by the subject were then averaged to determine the average level of nausea intra-operatively for each subject."|intra-operation|||units on a scale||Standard Deviation|Mean
736148|NCT00432991|Primary|Pre-Induction Nausea Score|Subject's self-rated nausea level on a scale of 0-3 immediately prior to induction of spinal anesthesia, where 0=no nausea, 1=mild nausea, 2=moderate nausea, and 3=severe nausea|immediately pre-induction|||units on a scale||Standard Deviation|Mean
736149|NCT00433004|Primary|PLAN B USE||1 year|||Participants|||Count of Participants
736150|NCT00433004|Primary|PREGNANCY RATES||1 year|||Participants|||Count of Participants
736152|NCT00433017|Secondary|Mean Change in Central Retinal Thickness of the Study Eye at Month 12|Optical coherence tomography (OCT) was used to assess the mean change in retinal thickness of the study eye at the Central Reading Center (CRC). A negative change from baseline indicates improvement, ie, less thickness.|Baseline and Month 12|Full analysis set, LOCF||μm||Standard Deviation|Mean
736153|NCT00433017|Secondary|Mean Change in Total Area of Leakage (Observed) of the Study Eye at Month 12|Fluorescein angiography (FA) was used to assess the mean change of leakage of the study eye at the Central Reading Center (CRC). A negative change from baseline indicates improvement, ie, less leakage.|Baseline and Month 12|Full analysis set based on observed data.||mm^2||Standard Deviation|Mean
736154|NCT00433017|Secondary|Percentage of Patients With Fluorescein Leakage in the Study Eye at Month 12|The proportion of patients with leakage of the study eye was assessed at the Central Reading Center (CRC) using Fluorescein angiography (FA).|Month 12|The Full Analysis Set (FAS) based on observed data.||Percentage of participants|||Number
736155|NCT00433017|Primary|Percent of Participants With a Treatment-free Interval of at Least 3 Months Following the Month 2 Visit|The number of patients with a ranibizumab treatment-free interval, ie, no active ranibizumab treatments for at least 3 months duration (at least 2 consecutive monthly visits), anytime following the Month 2 ranibizumab treatment. Only active ranibizumab treatments were considered.|Month 2 to Month 11|Full analysis set. Includes number of participants in the treatment group with at least one visit assessment of re-treatment.||Percentage of Participants|||Number
736156|NCT00433017|Primary|Change From Baseline in Best-corrected Visual Acuity (BCVA) at Month 12.|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increase in the VA score indicates improvement in visual acuity.|Baseline and Month 12|Performed on the Full analysis set (FAS) using the Last Observation Carried Forward (LOCF) approach for imputing missing data. FAS consisted of all patients as randomized that received at least one application of study drug and had at least one post-baseline assessment for best corrected visual acuity in the study eye.||Letters||Standard Deviation|Mean
736157|NCT00433160|Secondary|Back Pain Severity During Open Label Phases at 76 Weeks and 104 Weeks|Severity of back pain at 76 weeks and 104 weeks. Back pain was measured on a scale of 1 (none) to 4 (severe).|Baseline, 76 Weeks, 104 Weeks|Number of randomized participants who received at least one dose of study drug and with at least on post-treatment measurement.||participants|||Number
736158|NCT00433160|Secondary|Fractures by Investigators Assessment During Entire Study Period of 104 Weeks|"Vertebral and nonvertebral fractures assessed by the investigator or subinvestigator after starting the study treatment. Traumatic fractures were those caused by falling from above standing height or a high velocity (car) accident. Fractures were assessed to be fragility if they occurred without trauma."|Baseline Through 104 Weeks|Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.||number of fractures|||Number
736159|NCT00433160|Secondary|Vertebral Fractures by Central X-ray Assessment During Entire Study Period of 104 Weeks|Number of vertebral fractures observed from Visit 1 (study entry) through 104 weeks. All new or worsened vertebral fractures were defined as a deterioration of at least one grade in a semiquantitative score by X-ray assessment. Number of subjects with fractures and number of fractured vertebra(e) were counted.|Baseline through 104 Weeks|Number of randomized participants who received at least one dose of study drug and with at least on post-treatment measurement. The n's are the number of participants with fractures.||number of fractures|||Number
736160|NCT00433160|Secondary|Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX) During Open Label Phases at 76 Weeks and 104 Weeks|Percent change in serum type I collagen crosslinked C-telepeptide (CTX) from baseline to the individual visits and last measurement point.|Baseline, 76 Weeks, 104 Weeks|Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.||percent change in CTX||Standard Deviation|Mean
736161|NCT00433160|Secondary|Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP) During Open Label Phases at 76 Weeks and 104 Weeks|Percent change in serum bone-specific alkaline phosphatase (BAP) from baseline to the individual visits and last measurement point.|Baseline, 76 Weeks, 104 Weeks|Number of randomized participants with at least one dose of study drug and with at least one post-treatment measurement.||percent change in BAP||Standard Deviation|Mean
736162|NCT00433160|Secondary|Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP) During Open Label Phases at 76 Weeks and 104 Weeks|Percent change in serum procollagen I N-terminal propeptide (PINP) from baseline to the individual visits and last measurement point.|Baseline, 76 Weeks, 104 Weeks|Number of randomized participants with at least one dose of study drug and with at least one post-treatment measurement.||percent change in PINP||Standard Deviation|Mean
736163|NCT00433160|Secondary|Percent Change in Bone Mineral Density (BMD) at Femoral Neck During Open Label Phases at 76 Weeks and 104 Weeks|Percent change in bone mineral density at femoral neck from baseline to the last measurement point.|Baseline, 76 Weeks, 104 Weeks|Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.||percent change in BMD||Standard Deviation|Mean
736164|NCT00433160|Secondary|Percent Change in Bone Mineral Density (BMD) at Total Hip During Open Label Phases at 76 Weeks and 104 Weeks|Percent change in bone mineral density (BMD) at total hip from baseline to the last measurement point.|Baseline, 76 Weeks, 104 Weeks|Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.||percent change in BMD||Standard Deviation|Mean
736165|NCT00433160|Secondary|Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4) During Open Label Phases at 76 Weeks and 104 Weeks|Percent change in bone mineral density at lumbar spine (L1-L4) from baseline to the last measurement point.|Baseline, 76 Weeks, 104 Weeks|Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.||percent change in BMD||Standard Deviation|Mean
736166|NCT00433160|Secondary|Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4) During Open Label Phases at 76 Weeks and 104 Weeks|Percent change in bone mineral density (BMD) at lumbar spine (L2-L4) from baseline to the last measurement point.|Baseline, 76 Weeks, 104 Weeks|Number of randomized participants with at least one dose of study drug and at least one post-treatment measurement.||percent change in BMD||Standard Deviation|Mean
736168|NCT00433160|Secondary|Fractures by Investigators Assessment|"Vertebral and nonvertebral fractures assessed by the investigator or subinvestigator after starting the study treatment. Traumatic fractures were those caused by falling from above standing height or a high velocity (car) accident. Fractures were assessed to be fragility if they occurred without trauma."|Baseline through 52 Weeks|Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.||number of fractures|||Number
736169|NCT00433160|Secondary|Vertebral Fractures by Central X-ray Assessment|Number of vertebral fractures observed from Visit 1 (study entry) through Visit 19 (Week 52). All new or worsened vertebral fractures were defined as a deterioration of at least one grade in a semiquantitative score by X-ray assessment. Number of subjects with fractures and number of fractured vertebra(e) were counted.|Baseline through 52 weeks|Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement. The n's are the number of participants with fractures.||number of fractures|||Number
736170|NCT00433160|Secondary|Percent Change in Biochemical Markers of Bone Metabolism – Serum Type I Collagen Crosslinked C-telopeptide (CTX)|Percent change in serum type I collagen crosslinked C-telopeptide (CTX) from baseline to the individual visits and last measurement point.|Baseline to Weeks 4, 12, 24, 52|Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.||percent change in CTX||Standard Deviation|Mean
736171|NCT00433160|Secondary|Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP)|Percent change in serum bone-specific alkaline phosphatase (BAP) from baseline to the individual visits and last measurement point.|Baseline to Weeks 4, 12, 24, 52|Number of randomized participants with at least one dose of study drug and with at least one post-treatment measurement.||percent change in BAP||Standard Deviation|Mean
736172|NCT00433160|Secondary|Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP)|Percent change in serum procollagen I N-terminal propeptide (PINP) from baseline to the individual visits and last measurement point.|Baseline to Weeks 4, 12, 24, and 52|Number of randomized participants with at least one dose of study drug and with at least one post-treatment measurement.||percent change in PINP||Standard Deviation|Mean
736173|NCT00433160|Secondary|Percent Change in Bone Mineral Density (BMD) at Femoral Neck|Percent change in bone mineral density at femoral neck from baseline to the last measurement point.|Baseline to 52 Weeks|Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.||percent change in BMD||Standard Deviation|Mean
736174|NCT00433160|Secondary|Percent Change in Bone Mineral Density (BMD) at Total Hip|Percent change in bone mineral density (BMD) at total hip from baseline to the last measurement point.|Baseline to 52 Weeks|Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.||percent change in BMD||Standard Deviation|Mean
736175|NCT00433160|Secondary|Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4)|Percent change in bone mineral density at lumbar spine (L1-L4) from baseline to the last measurement point.|Baseline to 52 Weeks|Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.||percent change in BMD||Standard Deviation|Mean
736176|NCT00433160|Primary|Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4)|Percent change in bone mineral density (BMD) at lumbar spine (L2-L4) from baseline to the last measurement point.|Baseline to 52 weeks|Number of randomized participants with at least one dose of study drug and at least one post-treatment measurement.||percent change in BMD||Standard Deviation|Mean
736177|NCT00433199|Secondary|Percentage of Subjects Achieving Target Range for Testosterone Cav During the Open-label Period at Day 364.|The success at Day 364 was defined as >=75% of subjects within the normal serum total testosterone concentration range of 300-1000 ng/dL. The Lower bounds of the 95% CI was to be not less than 65%.|Day 364|The analysis was done on the Full analysis set with patients included in the open-label period with a measurement at Day 364.||Percentage of subjects||95% Confidence Interval|Number
736178|NCT00433199|Secondary|Percentage of Subjects Achieving Target Range for Testosterone Cav During the Open-label Period at Day 266.|The success at Day 266 was defined as >=75% of subjects within the normal serum total testosterone concentration range of 300-1000 ng/dL. The Lower bounds of the 95% CI was to be not less than 65%.|Day 266|The analysis was done on the Full analysis set with patients included in the open-label period with a measurement at Day 266.||Percentage of subjects||95% Confidence Interval|Number
736179|NCT00433199|Secondary|Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 182|Cav results were required to fall within the normal range of 300-1000 ng/dL at Day 182. Success was defined as >=75% of subjects on active treatment within the normal serum testosterone concentration range of 300-1000 ng/dL. In addition, the lower bound of the 95% CI was to be not less than 65% based on the Day 182 PK results.|Day 182|The analysis was done on the Full analysis set with patients included in the double-blind period with a measurement at Day 182.||Percentage of subjects||95% Confidence Interval|Number
736180|NCT00433199|Secondary|Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 56|Cav results were required to fall within the normal range of 300-1000 ng/dL at Day 56. Success was defined as >=75% of subjects on active treatment within the normal serum testosterone concentration range of 300-1000 ng/dL. In addition, the lower bound of the 95% CI was to be not less than 65% based on the Day 56 PK results|Day 56|The analysis was done on the Full analysis set with patients included in the double-blind period with a measurement at Day 56.||Percentage of subjects||95% Confidence Interval|Number
736181|NCT00433199|Secondary|Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 14|Cav results were required to fall within the normal range of 300-1000 ng/dL at Day 14. Success was defined as >=75% of subjects on active treatment within the normal serum testosterone concentration range of 300-1000 ng/dL. In addition, the lower bound of the 95% CI was to be not less than 65% based on the Day 14 PK results|Day 14|The analysis was done on the Full analysis set with patients included in the double-blind period with a measurement at Day 14.||Percentage of subjects||95% Confidence Interval|Number
736182|NCT00433199|Primary|Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 112|Cav results were required to fall within the normal range of 300-1000 ng/dL. Success in the study was defined as >=75% of subjects on active treatment within the normal serum testosterone concentration range of 300-1000 ng/dL. In addition, the lower bound of the 95% CI was to be not less than 65% based on the Day 112 Parmacokinetics (PK) results|Day 112|The analysis was done on the Full analysis sample defined as the subjects who were included in the Safety Sample and who had data for at least one post-Baseline assessment of any efficacy measurement up to and including Day 182 (double-blind period). The number correspond to the number of subjects having a measurement at Day 112;||Percentage of subjects||95% Confidence Interval|Number
736183|NCT00433290|Secondary|Adverse Events Reported as Reason for Discontinuation in Nonresponders|Nonresponders were defined as participants with a <30% reduction from baseline to Visit 7 (7 weeks) in Brief Pain Inventory average pain score.|over 13 Weeks|Number of randomized participants who were nonresponders at Visit 4 (7 weeks).||participants|||Number
736184|NCT00433290|Secondary|Number of Nonresponders at Week 7 Who Responded at Week 13 Endpoint|Response was defined as a >=30% reduction from baseline to endpoint in Brief Pain Inventory average pain score. Nonresponders were defined as participants with a <30% reduction from baseline to Visit 4 (7 Weeks) in Brief Pain Inventory average pain score.|13 Weeks|Number of randomized participants who were non-responders at Visit 4 (7 weeks) and with non-missing response values.||participants|||Number
736185|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Average Pain Score in Nonresponders|"A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Non-Responders were defined as patients with a <30% reduction from baseline to visit 4 (7 weeks) in Brief Pain Inventory (BPI) average pain score."|Baseline and 13 Weeks|Number of participants who did not respond to treatment after 6 weeks of treatment.||units on a scale||Standard Deviation|Mean
736186|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Vital Signs - Weight||Baseline and 13 Weeks|Number of participants with a baseline and at least one non-missing post-baseline value.||kilograms||Standard Deviation|Mean
736187|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure||Baseline and 13 Weeks|Number of participants with a baseline and at least one non-missing post-baseline value.||mm Hg||Standard Deviation|Mean
736188|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Vital Signs - Heart Rate||Baseline and 13 Weeks|Number of participants with a baseline and at least one non-missing post-baseline value.||beats per minute||Standard Deviation|Mean
736189|NCT00433290|Secondary|Statisically Significant Change From Baseline to 13 Week Endpoint in Chloride||Baseline and 13 Week Endpoint|Number of randomized participants with a baseline and at least one non-missing post-baseline value.||millimole per Liter||Standard Deviation|Mean
736190|NCT00433290|Secondary|Statisically Significant Change From Baseline to 13 Week Endpoint in Laboratory Analytes||Baseline and 13 Weeks|Number of participants with a baseline and at least one non-missing post-baseline value.||Units/Liter||Standard Deviation|Mean
736191|NCT00433290|Secondary|Adverse Events Reported as Reason for Discontinuation||over 13 weeks|All randomized participants.||participants|||Number
736192|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Average Interference|A self-reported scale that measures interference of pain on average of the 7 questions assessing the interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The average Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline and 13 Weeks|The number of randomized participants with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Deviation|Mean
736193|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Enjoyment of Life|A self-reported scale that measures the interference of pain in the past 24 hours on enjoyment of life. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline and 13 Weeks|The number of randomized participants with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Deviation|Mean
736194|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Sleep|A self-reported scale that measures the interference of pain in the past 24 hours on sleep. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline and 13 Weeks|The number of randomized participants with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Deviation|Mean
736195|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Relations With Other People|A self-reported scale that measures the interference of pain in the past 24 hours on relations with other people. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline and 13 Weeks|The number of randomized participants with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Deviation|Mean
736196|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Normal Work|A self-reported scale that measures the interference of pain in the past 24 hours on normal work. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline and 13 Weeks|The number of randomized participants with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Deviation|Mean
736197|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Walking Ability|A self-reported scale that measures the interference of pain in the past 24 hours on walking ability. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline and 13 Weeks|The number of randomized participants with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Deviation|Mean
736198|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Mood|A self-reported scale that measures the interference of pain in the past 24 hours on mood. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline and 13 Weeks|The number of randomized participants with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Deviation|Mean
736199|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: General Activity|A self-reported scale that measures the interference of pain in the past 24 hours for general acitivity. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline and 13 Weeks|The number of randomized participants with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Deviation|Mean
736200|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Pain Right Now Score|A self-reported scale that measures the severity of pain based on the pain right now. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline and 13 Weeks|The number of randomized participants with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Deviation|Mean
736201|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Average Pain Score|A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline and 13 Weeks|Number of randomized participants with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Deviation|Mean
736202|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Least Pain Score|A self-reported scale that measures the severity of pain based on the least pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline and 13 Weeks|Number of randomized participants with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Deviation|Mean
736203|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) Severity: Worst Pain Score|A self-reported scale that measures the severity of pain based on the worst pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline and 13 Weeks|Number of randomized participants with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Deviation|Mean
736204|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)|A 14-item questionnaire with 2 subscales: anxiety (7 items) and depression (7 items). Each item is rated on a 4-point scale (0 to 3), giving maximum scores of 21 for anxiety subscale. Scores of 11 or more are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.'|Baseline and 13 Weeks|Number of randomized participants with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Deviation|Mean
736205|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Beck Depression Inventory - II (BDI-II)|A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.|Baseline and 13 Weeks|All randomized participants. Intent-to-treat analysis.||units on a scale||Standard Deviation|Mean
736206|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in EuroQoL Questionnaire – 5 Dimension (EQ-5D)|The EQ-5D is an assessment of one's overall health. Consists of 5 items. Patients choose 1 of 3 options that best describe the status of each item. The EQ-5D US based index scores range from -0.11 to 1.0 where a score of 1.0 indicates perfect health. A positive change from baseline indicates health improvement.|Baseline and 13 Weeks|Number of randomized participants with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Deviation|Mean
736207|NCT00433290|Secondary|Mean Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) Medical Component Summary (MCS), Physical Component Summary (PCS), and Domain Scores|MCS and PCS scores=0-100 (higher scores indicate better health status). Domain scores:general health=5-25, physical functioning=10-30, Role-physical=4-8, Role-emotional=3-6, social functioning=2-10, bodily pain=2-11, vitality=4-24, mental health=5-30.|Baseline and 13 Weeks|Number of randomized participants with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Deviation|Mean
736208|NCT00433290|Secondary|Number of Participants Who Responded to Treatment at 13 Week Endpoint|Response to treatment was defined as a ≥ 30% reduction from baseline to endpoint in Brief Pain Inventory (BPI) average pain score. The BPI measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|13 Weeks|Number of randomized participants with non-missing response values.||participants|||Number
736209|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Clinical Global Impression of Severity (CGI-S)|Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients.|Baseline and 13 Weeks|All randomized participants with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Deviation|Mean
736210|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Weekly Mean of the 24-Hour Average Pain and Worst Pain Scores|This assesses the weekly mean of the average pain and worst pain experienced over the last 24-hours. This is an ordinal scale with scores for each subscale (average pain and worst pain) ranging from 0 (no pain) to 10 (worst possible pain). Change = endpoint minus baseline.|Baseline and 13 Weeks|All randomized participants with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Deviation|Mean
736211|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale|The WOMAC index (pain, stiffness, physical function subscales) will be completed by the patient. The stiffness subscale has 2 questions on stiffness associated with time of day (morning versus later in the day). Each question is answered using a 5-point Likert scale (0 to 4). The pain subscale has a range of scores of 0 (none) to 8 (extreme).|Baseline and 13 Weeks|All randomized participants with baseline and at least one non-missing post-baseline value.||units on a scale||Standard Deviation|Mean
736212|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale|The WOMAC index (pain, stiffness, physical function subscales) will be completed by the patient. The pain subscale has 5 questions on pain associated with every day tasks. Each question is answered using a 5-point Likert scale (0 to 4). The pain subscale has a range of scores of 0 (none) to 20 (extreme).|Baseline and 13 Weeks|All randomized participants with baseline and at least one non-missing post-baseline value.||units on a scale||Standard Deviation|Mean
736213|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Physical Function Subscale|The WOMAC index (pain, stiffness, physical function subscales) will be completed by the patient. The physical function subscale has 17 questions on physical function difficulties with every day tasks. Each question is answered using a 5-point Likert scale (0 to 4). The physical function subscale has a range of scores of 0 (none) to 68 (extreme).|Baseline and 13 Weeks|All randomized participants with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Deviation|Mean
736214|NCT00433290|Secondary|Mean Values at 13 Week Endpoint in Patient Global Impression of Improvement (PGI-I)|A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).|13 Weeks|All randomized participants with at least one non-missing post-baseline value.||units on a scale||Standard Deviation|Mean
736215|NCT00433290|Primary|Change in Brief Pain Inventory (BPI) 24-hour Average Rating|A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Changes are timepoint minus baseline.|Baseline, Week 4, Week 7, Week 13|All randomized participants. Intent-to-treat analysis.||units on a scale||Standard Error|Least Squares Mean
736216|NCT00433329|Primary|Number of Patients Reaching a 6-Minute Walk Test (6MWT) Distance ≥ 380 Meters|The 6MWT is a non encouraged test, which measures the walking distance covered over a 6 minute period|at 16 weeks and at 28 weeks of a stepped approach to therapy|Intention to treat population||participants||95% Confidence Interval|Number
736217|NCT00433381|Secondary|Predictive Value of CBV and Lac/NAA in Assessing 6-month Progression-free Survival||From randomization to six months.||||||
736218|NCT00433381|Secondary|Correlation of Degree of Cerebral Blood Volume (CBV) and Lactate (Lac) to Patient Response||From randomization to two weeks following initiation of bevacizumab.||||||
736219|NCT00433381|Secondary|Correlation of Degree of Cerebral Blood Volume (CBV) and Lactate (Lac) to N-acetylaspartate (NAA) (Lac/NAA) Ratio||From registration to two weeks following initiation of bevacizumab.||||||
736220|NCT00433381|Secondary|Accuracy of Local Interpretation on the 6-month Progression-free Survival Using Central Review as the Reference Standard||From randomization to six months.||||||
736221|NCT00433381|Secondary|Agreement Between Local Interpretation and Central Interpretation of the Standard MRI on the 6-month Progression-free Survival|Assessed using a McNemar’s test. The sensitivity and specificity of the local interpretation of the 6-month progression-free survival will be estimated using the central review as the reference standard. In particular, for patients progressed at 6 months according to central review, the sensitivity of the local interpretation will be estimated and the exact confidence interval will be calculated. The specificity and the associated exact confidence interval of the local interpretation will be calculated in a similar way.|From randomization to six months.||||||
736222|NCT00433381|Secondary|Best Objective Response Rate (Complete Response, Partial Response, Stable Disease, Progression) in Both Arms|Only patients who have measurable disease present at baseline will be considered evaluable for response except those who are removed from the study before the end of cycle 1 for reasons other than clinical progression (such as toxicity). Tumor size will be measured in millimeters and is the largest crosssectional area using perpendicular measurements of contrast enhancing abnormality. Complete response (CR): Complete disappearance of all enhancing tumor on consecutive MRI scans at least 1 month apart, off corticosteroids, and neurologically stable or improved. Partial response (PR): ≥ 50% decrease in size of enhancing tumor on consecutive MRI scans at least 1 month apart, corticosteroids stable or reduced, and neurologically stable or improved. Stable disease (SD): Does not qualify for CR, PR, or PD. Progression: ≥ 25% increase in the size of enhancing tumor or any new tumor; or neurologically worse, and steroids stable or increased.|From randomization to progression, death, or last follow-up.||||||
736223|NCT00433381|Secondary|Six-month Progression-free Survival (Bevacizumab and Temozolomide Arm)||From randomization to six months.||||||
736224|NCT00433381|Primary|Rate of Treatment Discontinuation Due to Treatment-related Medical Complications(Bevacizumab and Temozolomide Arm)|If 6 or fewer of 29 patients stop treatment due to medical conditions, then null hypothesis of rate = 0.35 will be rejected, type I and type II error of 0.10. Alternative hypothesis rate of 0.15.|From randomization to end of treatment (treatment can continue up to 24 months for patients with stable or responding tumor).|The first 29 eligible patients who received protocol treatment were to be evaluated for treatment tolerability.||participants|||Number
736225|NCT00433381|Primary|Six-month Progression-free Survival (PFS) for Bevacizumab and Irinotecan Hydrochloride Arm|Progression-free survival is defined as time from randomization to date of progression or date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive without progression are considered to be censored at the date of last contact.|From randomization to six months.|Eligible patients who were not removed from the study before the end of cycle 1 for reasons other than clinical progression (such as toxicity).||percentage of participants||95% Confidence Interval|Number
736226|NCT00433446|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|Patients were assessed for adverse events after every cycle (1 cycle = 14 days) of protocol treatment|Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.||Participants|||Number
736227|NCT00433446|Secondary|Objective Response (Confirmed and Unconfirmed Complete and Partial Response) Among Those Patients With Measurable Disease|Complete Response (CR) is a complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. PSA = .2 ng/ml. Partial Response (PR) applies only to patients with at least one measurable lesion. Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions.|Assessed every 3 cycles (1 cycle= 14 days) of treatment until progression|All eligible patients with measurable disease who started treatment were included in the analysis||participants|||Number
736229|NCT00433446|Primary|Confirmed Prostate-Specific Antigen (PSA) Response|PSA response is defined as a 50% reduction in accordance with the recommendations of the orginal PSA Working Group. Confirmed PSA response is defined as PSA response at two or more time points at least 4 weeks apart, without objective disease progression or symptomatic deterioration.|Assessed every 3 cycles (1 cycle = 14 days) until progression|All eligible patients who started treatment were included in the analysis||percentage of participants||95% Confidence Interval|Number
736230|NCT00433446|Secondary|Progression-free Survival (PFS)|PFS is defined as tumor progression by Response Evaluation Criteria in Solid Tumors (RECIST) criteria, PSA progression by PSA Working Group criteria, or symptomatic deterioration.|Assessed every 3 cycles (1 cycle = 14 days) until progression|All eligible patients who started treatment were included in the analysis||months||95% Confidence Interval|Median
736231|NCT00433537|Secondary|3-year Overall Survival (OS)|OS for patients who received maintenance rituximab or ASCT after VcR-CVAD induction is defined as time from start of maintenance rituximab or ASCT to death. Patients alive at last follow-up were censored.|Assessed every 6 months for 5 years, and then yearly thereafter.|Eligible and treated patients who received maintenance rituximab or ASCT||probability||95% Confidence Interval|Number
736232|NCT00433537|Secondary|2-year Progression-free Survival (PFS)|PFS for patients who received maintenance rituximab or ASCT after VcR-CVAD induction is defined as time from start of maintenance rituximab or ASCT to earlier of disease progression or death. Patients alive and progression-free at last follow-up were censored.|Assessed every 6 months for 5 years, and then yearly thereafter.|Eligible and treated patients who received maintenance rituximab or ASCT||probability||95% Confidence Interval|Number
736233|NCT00433537|Primary|Complete Response (CR) Rate|Number of eligible, treated participants who achieve complete response. Response criteria are based upon the criteria from the Revised Response Criteria for Malignant Lymphoma (Cheson et al., 2007). Complete response is defined as complete disappearance of all detectable clinical evidence of disease, and disease-related symptoms if present prior to therapy.|Assessed after VcR-CVAD cycles 2, 4, and 6.|Eligible and treated patients||proportion||95% Confidence Interval|Number
736234|NCT00433550|Secondary|Time to Treatment Failure|Time to treatment failure is defined to be the time from the date of registration to the date at which the patient is removed from treatment due to progression, toxicity, or refusal. If the patient is considered to have had a major treatment violation or is taken off study as a non-protocol failure, the patient will be censored on the date they are removed from treatment. Time to treatment failure will be analyzed using Kaplan-Meier methods.|Up to 2 years|One patient was later found to be a major treatment violation during cycle 1 and was not included in this analysis. All the other 32 patients were analyzed together for this endpoint.||months||95% Confidence Interval|Median
736235|NCT00433550|Secondary|Duration of Response|Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient’s objective status is first noted to be either a CR or PR to the date progression is documented. Duration of response will be analyzed using Kaplan-Meier methods.|Up to 2 years|All patients who achieved a CR or PR are included in this analysis.||months||95% Confidence Interval|Median
736236|NCT00433550|Secondary|Progression Free Survival|Time to disease progression is defined as the time from registration to the earlier of documentation of disease progression or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The distribution of time to progression will be estimated using Kaplan-Meier methodology.|Up to 2 years|One patient was later found to be a major treatment violation during cycle 1 and was not included in this analysis. All the other 32 patients were analyzed together for this endpoint.||months||95% Confidence Interval|Median
736237|NCT00433550|Secondary|Overall Survival|Overall survival will be defined as the time from registration to death. Patients lost to follow-up for this endpoint will be censored at the date of last contact (i.e., last known alive). The distribution of overall survival will be estimated using Kaplan-Meier methodology.|Up to 2 years|One patient was later found to be a major treatment violation during cycle 1 and was not included in this analysis. All the other 32 patients were analyzed together for this endpoint.||months||95% Confidence Interval|Median
736238|NCT00433550|Primary|Confirmed Tumor Response Rate (Proportion of Participants With Complete Response)|Evaluated using RECIST version 1.0. Confirmed tumor response rate was defined as achieving partial response (PR) or complete response (CR) in two consecutive assessments at least 6 weeks apart. CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. The confirmed response rate is reported as the number of participants with confirmed responses divided by the number of evaluated participants.|36 weeks|One patient was later found to be a major treatment violation during cycle 1 and was not included in this analysis. All the other 32 patients were analyzed together for this endpoint.||proportion of patients||95% Confidence Interval|Number
736239|NCT00433654|Secondary|Ventricular Sensed Amplitude|Average ventricular sensed amplitude.|3 or 4 months post-implant|||millivolt (mV)||Standard Deviation|Mean
736240|NCT00433654|Secondary|Atrial Sensed Amplitude|Average atrial sensed amplitude.|3 or 4 months post-implant|||millivolt (mV)||Standard Deviation|Mean
736241|NCT00433654|Secondary|Ventricular Pacing Capture Threshold|Average ventricular pacing capture threshold. Pacing capture threshold is the energy needed to pace the heart.|3 or 4 months post-implant|||Volts||Standard Deviation|Mean
736242|NCT00433654|Secondary|Atrial Pacing Capture Threshold|Average atrial pacing capture threshold. Pacing capture threshold is the energy needed to pace the heart.|3 or 4 months post-implant|Includes all subjects with data.||Volts||Standard Deviation|Mean
736243|NCT00433654|Secondary|Ventricular Lead Handling Rating|Physicians' rated ventricular lead handling during the implant on a scale of -3 to +3 where: -3 = well below expectations; -2 = moderately below expectations; -1 = slightly below expectations; 0 = met expectations; +1 = slightly above expectations; +2 = moderately above expectations; and +3 = well above expectations.|During implant|All surveys completed are included||Units on a scale||Standard Deviation|Mean
736244|NCT00433654|Secondary|Atrial Lead Handling Rating|Physicians' rated atrial lead handling during the implant on a scale of -3 to +3 where: -3 = well below expectations; -2 = moderately below expectations; -1 = slightly below expectations; 0 = met expectations; +1 = slightly above expectations; +2 = moderately above expectations; and +3 = well above expectations.|During implant|All surveys completed are included||Units on a scale||Standard Deviation|Mean
736245|NCT00433654|Secondary|Ventricular Lead Impedance Change|Subjects' ventricular lead impedance (a measure of electrical resistance) was measured at the 9-12 week visit (before the MRI scan was performed for those in the MRI group) and at the 4-month visit (one month post-MRI). Both measurements were conducted by the pacemaker. The difference between the two is reported.|9-12 week visit and 4-month visit|Subjects with non-missing data are included||ohms||Standard Deviation|Mean
736246|NCT00433654|Secondary|Atrial Lead Impedance Change|Subjects' atrial lead impedance (a measure of electrical resistance) was measured at the 9-12 week visit (before the MRI scan was performed for those in the MRI group) and at the 4-month visit (one month post-MRI). Both measurements were conducted by the pacemaker. The difference between the two is reported.|9-12 week visit and 4-month visit|Subjects with non-missing data are included||ohms||Standard Deviation|Mean
736247|NCT00433654|Secondary|Occurrence of Arrhythmias|Number of participants with sustained ventricular arrhythmias or asystole episodes that occurred during the MRI scan that were considered attributable to the MRI scan|During the MRI scan|Arrhythmia was defined as heart rate > 150 beats per minute for > 30 seconds. Asystole was defined as standstill 6 seconds in electrical activity of the heart. Episodes were assessed via pulse oximetry monitoring during MRI scans.||participants|||Number
736248|NCT00433654|Secondary|System Related Adverse Device Effects Due to Labeling Instructions|Number of participants with adverse device effects (ADEs) that resulted from insufficiencies or inadequacies in the instructions for use or deployment of the device, or from user error. ADE's were investigator-reported.|Implant through 18 months post-implant|Includes all subjects undergoing an MRI using the instructions in the protocol.||participants|||Number
736249|NCT00433654|Secondary|Subjects With System-related Complications|Subjects with a complication related to the implanted system, which consisted of the pacemaker, leads to the right chambers of the heart (atrium and ventricle), pacemaker software, and programmer. All adverse events in the time frame were recorded at the subject's center and assessed by a centralized Adverse Event Advisory Committee. The committee determined whether each adverse event was a complication (requiring invasive intervention), and whether the event was related to the system.|Implant to 4 Months|All implanted subjects with either a 4-month follow-up or a system-related complication within the first 4 months post-implant are included.||participants|||Number
736250|NCT00433654|Primary|Ventricular Sensed Amplitude Success|Subjects' ventricular sensed amplitude (the minimum energy produced by the heart's ventricle that the pacemaker can sense) was measured at the 9-12 week visit (before the MRI scan was performed for those in the MRI group) and at the 4-month visit (one month post-MRI). Subjects were considered successful if their sensed amplitude did not decrease by more than 50% and remained above 5.0 millivolts (mV).|9-12 week visit to 4-month visit|Subjects were excluded from this analysis if: they did not have ventricular sensed amplitude measurements at 9-12 weeks or 4 months; or (for the MRI group) their MRI scan was not done according to protocol; or if their 9-12 week ventricular sensed amplitude was less than 5.0 mV.||participants|||Number
736251|NCT00433654|Primary|Atrial Sensed Amplitude Success|Subjects' atrial sensed amplitude (the minimum energy produced by the heart's atrium that the pacemaker can sense) was measured at the 9-12 week visit (before the MRI scan was performed for those in the MRI group) and at the 4-month visit (one month post-MRI). Subjects were considered successful if their sensed amplitude did not decrease by more than 50% and remained above 1.5 millivolts (mV).|9-12 week visit to 4-month visit|Subjects were excluded from this analysis if: they did not have atrial sensed amplitude measurements at 9-12 weeks or 4 months; or (for the MRI group) their MRI scan was not done according to protocol; or if their 9-12 week atrial sensed amplitude was less than 1.5 mV.||participants|||Number
736252|NCT00433654|Primary|Ventricular Pacing Capture Threshold Success|Subjects' ventricular pacing capture threshold (the energy sent from the pacemaker needed to make the heart's ventricle beat) was measured at the 9-12 week visit (before the MRI scan was performed for those in the MRI group) and at the 4-month visit (one month post-MRI). Subjects were considered successful if their pacing capture threshold did not increase by 1.0 volt (V) or more.|9-12 week visit to 4-month visit|Subjects were excluded from this analysis if: they did not have ventricular pacing capture threshold measurements at 9-12 weeks or 4 months; or (for the MRI group) their MRI scan was not done according to protocol.||participants|||Number
736253|NCT00433654|Primary|Atrial Pacing Capture Threshold Success|Subjects' atrial pacing capture threshold (the energy sent from the pacemaker needed to make the heart's atrium beat) was measured at the 9-12 week visit (before the MRI scan was performed for those in the MRI group) and at the 4-month visit (one month post-MRI). Subjects were considered successful if their pacing capture threshold did not increase by 1.0 volt (V) or more.|9-12 week visit to 4-month visit|Subjects were excluded from this analysis if: they did not have atrial pacing capture threshold measurements at 9-12 weeks or 4 months; or (for the MRI group) their MRI scan was not done according to protocol.||participants|||Number
736254|NCT00433654|Primary|Magnetic Resonance Imaging (MRI)-Related Complications|Subjects with a complication related to the MRI scan. All adverse events in the time frame were recorded at the subject's center and assessed by a centralized Adverse Event Advisory Committee. The committee determined whether each adverse event was a complication (requiring invasive intervention), and whether the event was related to the MRI scan.|MRI scan to one-month post-MRI scan|Subjects who underwent an MRI scan following study protocol-specified instructions are included. Of the 243 subjects who completed a one-month post-MRI (4-month) visit, 32 did not complete the MRI scan according to the protocol instructions, and are not included.||participants|||Number
736255|NCT00433745|Secondary|Disease Response|Clinical response of underlying malignancy to the vaccination|7 weeks after last dose of vaccine|||participants|||Number
736256|NCT00433745|Primary|Cellular Immune Response|Minimum criterion for a cellular immune response was defined as the emergence of detectable T cell frequency against Willm's tumor 1 (WT1) when the pre-study analysis found no response, or a twofold increase in T cell frequency at any post vaccination time point|7 weeks after last dose of vaccine|||participants|||Number
736257|NCT00433771|Secondary|Number of Device-Related Adverse Events|Adverse Events reported during the trial were evaluated for their device-and procedure-relatedness and severity in order to assess device safety. An adverse event was defined as any untoward medical occurance in a study participant.|Until 6 months or death|The intent-to-treat cohort of 58 patients was used for this analysis. Of all the events reported for this population, only 6 events were reported as device-related.||Events|||Number
736259|NCT00433771|Secondary|Stent Patency at 6 Months|Per the protocol, stent patency was defined as lack of obstructive symptoms and/or a normal total bilirubin level. Patency evaluations at Month 6 were done on those patients with an assessment of biliary obstructive symptoms (bilirubin levels were not measured at Month 6).|6 Months|23 patients reached the Month 6 follow up point and were evaluated for stent patency.||Participants|||Number
736260|NCT00433771|Secondary|Stent Patency at 3 Months|Per the protocol, stent patency was defined as lack of obstructive symptoms and/or a normal total bilirubin level. Patency evaluations at Month 3 were done on those patients with an assessment of biliary obstructive symptoms (bilirubin levels were not measured at Month 3).|3 Months|34 patients reached the Month 3 follow up point and were evaluated for stent patency.||Participants|||Number
736261|NCT00433771|Secondary|Stent Patency at 1 Month|Per the protocol, stent patency was defined as lack of obstructive symptoms and/or a total bilirubin level of less than 3mg/dl. Patency evaluations at the Month 1 visit were done on those patients with both a total bilirubin level and assessment of biliary obstructive symptoms.|1 month|45 out of 55 evaluable patients had both bilirubin and obstructive symptom assessment at Month 1.||Participants|||Number
736262|NCT00433771|Secondary|Bilirubin Level Reduction|Total bilirubin levels at 1 month follow-up were compared to initial bilirubin levels. Bilirubin level reduction was defined as total bilirubin levels being below 3mg/dl, or reduced by >30% if the initial baseline value was greater than 3mg/dl.|1 month|45 out of 55 evaluable patients reported a baseline and a Month 1 total bilirubin level and were therefore analyzed for bilirubin levels reduction.||Participants|||Number
736263|NCT00433771|Secondary|Clinical Success at 6 Months After Stent Procedure as Defined by the Reduction of Biliary Obstruction Symptoms|Clinical success was defined as the reduction of biliary obstruction symptoms after treatment with the device.Symptoms included jaundice,pruritis,right upper quadrant abdominal pain,nausea,vomiting,fever and dark urine.For each patient,a total number of symptoms at baseline and at all post-treatment visits were recorded.Reduction in obstruction symptoms was defined as having a lower total number of symptoms at a post-treatment follow up visit compared to baseline.Here we report the number of subjects with a reduced total number of biliary obstructive symptoms at 6 months after stent treatment.|6 months|23 out of 55 evaluable subjects reached the 6-Month follow up visit and were assessed for reduction of biliary obstructive symptoms compared to baseline.||Participants|||Number
736264|NCT00433771|Secondary|Clinical Success at 3 Months After Stent Procedure as Defined by the Reduction of Biliary Obstruction Symptoms|Clinical success was defined as the reduction of biliary obstruction symptoms after treatment with the device.Symptoms included jaundice,pruritis,right upper quadrant abdominal pain,nausea,vomiting,fever and dark urine.For each patient,a total number of symptoms at baseline and at all post-treatment visits were recorded.Reduction in obstruction symptoms was defined as having a lower total number of symptoms at a post-treatment follow up visit compared to baseline.Here we report the number of subjects with a reduced total number of biliary obstructive symptoms at 3 months after stent treatment.|3 months|34 out of 55 evaluable subjects reached the 3-Month Follow Up visit and were evaluated for reduction of biliary obstruction symptoms compared to baseline.||Participants|||Number
736265|NCT00433771|Secondary|Clinical Success at 1 Month After Stent Procedure as Defined by Reduction of Biliary Obstruction Symptoms|Clinical success was defined as the reduction of biliary obstruction symptoms after treatment with the device.Symptoms included jaundice,pruritis,right upper quadrant abdominal pain,nausea,vomiting,fever and dark urine.For each patient,a total number of symptoms at baseline and at all post-treatment visits were recorded.Reduction in obstruction symptoms was defined as having a lower total number of symptoms at a post-treatment follow up visit compared to baseline.Here we report the number of subjects with a reduced total number of biliary obstructive symptoms at 1 month after stent treatment.|1 Month|49 out of 55 evaluable subjects reached the 1-Month Follow Up visit and were evaluated for reduction of biliary obstruction symptoms.||Participants|||Number
736266|NCT00433771|Secondary|Re-interventions|Per the study protocol, re-intervention was defined as any type of endoscopic, percutaneous, or surgical procedure to improve biliary drainage after insertion of the initial stent.|Until 6 months or death|The re-intervention rate was assessed in the evaluable cohort of 55 patients.||Participant|||Number
736267|NCT00433771|Secondary|Ability to Successfully Remove a Stent Upon Removal Attempt|The ability to successfully remove a stent upon a removal attempt was defined as removal without any clinically-significant complications or technical difficulties.|6 months|2 patients of the evaluable cohort (n=55) were assessed for success of stent removal without any complications/technical difficulties.||Participants|||Number
736268|NCT00433771|Secondary|Technical Success|Technical success is defined as the ability to deploy the stent in satisfactory position across the stricture. It was assessed in the intent-to-treat cohort.|At treatment|Device Safety and Technical Success were evaluated for the 58 intent-to-treat patients||participants|||Number
736269|NCT00433771|Primary|Adequate Clinical Palliation of the Biliary Obstruction|Adequate clinical palliation of the biliary obstruction as demonstrated by the absence of stent occlusion within 6 month follow up or prior to death, whichever comes first in the evaluable subject cohort of 55 patients.|6 months|Per protocol, assessment of the primary endpoint was performed on the evaluable cohort, defined as group of patients who signed the Informed Consent Form, met eligibility criteria, received a stent and had at least one week of follow up.||participants|||Number
736270|NCT00433836|Secondary|Change From Baseline in Mean Ambulatory Systolic Blood Pressure (ASBP) and Mean Ambulatory Diastolic Blood Pressure (ADBP) Over 24 Hours in Subset of Patients|The effect of valsartan and enalapril between baseline and visit 6 on 24-hour mean ambulatory systolic and diastolic blood pressure (ASBP, ADBP) in a subset of patients.|Baseline and Week 8|A subset of approximately 100 - 150 patients from selected centers was expected to undergo Ambulatory Blood Pressure Monitoring at baseline (Week 0) and at Week 8; however, only 56 patients chose to participate in this aspect of the study.||mm Hg||Standard Deviation|Mean
736271|NCT00433836|Secondary|Decrease in MSSBP to < 95th Percentile for Age, Gender and Height|The percentage of children whose MSSBP decreased to <95th percentile for age, gender, and height on valsartan vs. enalapril monotherapy at week 12.|at week 12|Intent-to-treat. Only patients who had both baseline and endpoint values are included.||Percentage of participants|||Number
736272|NCT00433836|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)|The change from baseline in mean sitting diastolic blood pressure (MSDBP) after 12 weeks of treatment as measured by office blood pressure.|Baseline and Week 12|Intent-to-treat. Only patients who had both baseline and endpoint values are included.||mm Hg||Standard Error|Least Squares Mean
736278|NCT00440271|Secondary|Occurrence of TPV Inhibitory Quotient (IQ) >60 at Each Visit Where TPV Concentration is Measured||after 2 weeks of treatment (Weeks 2, 4, 8, 12, 24, 36, and 48)|The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.|||||
736279|NCT00440271|Secondary|Patients Adherence With Study Medication Based on Pill Count||after 4 weeks of treatment|The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.|||||
736280|NCT00440271|Secondary|Tipranavir (TPV) and Ritonavir (RTV) Trough Concentrations at Week 2, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48||after 2 weeks of treatment till Week 48 (Weeks 2, 4, 8, 12, 24, 36, and 48)|The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.|||||
736281|NCT00440271|Secondary|Change in Ratio of CD38+/CD8+ From Baseline to Week 48||after 2 weeks of treatment till Week 48 (Weeks 2, 4, 8, 12, 24, 36, and 48)|The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.|||||
736282|NCT00440271|Secondary|Change in CD4+ and CD8+ Cell Counts From Baseline at Each Visit Including Visits at Week 24 and Week 48||after 2 weeks of treatment till Week 48 (Weeks 2, 4, 8, 12, 24, 36, and 48)|The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.|||||
736283|NCT00440271|Secondary|Time to New AIDS or AIDS Related Progression Event or Death||after Day 1 of treatment|The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.|||||
736284|NCT00440271|Secondary|Time to Treatment Failure|For patients who never achieve a confirmed virologic response, time to treatment failure is defined as 0. For patients who achieve a confirmed virologic response, time to treatment failure is the earliest time of either: death, permanent discontinuation of the study drug or loss to follow-up, introduction of a new anti-retroviral drug to the regimen if it is not solely related to either toxicity or intolerance clearly attributable to a background drug, but not the study drug, or first occurrence of a VL >50 copies/mL at two consecutive measurements after having achieved a VL <50 copies/mL.|after Day 1 of treatment|The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.|||||
736285|NCT00440271|Secondary|Change in Viral Load From Baseline at Each Visit||after 2 weeks of treatment (Weeks 2, 4, 8, 12, 24, 36, and 48)|The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.|||||
736286|NCT00440271|Secondary|Percentage of Participants Whose ≥1 log10 Drop in Viral Load From Baseline at All Visits, Including Visits at Weeks 24 and 48||after 2 weeks of treatment (Weeks 2, 4, 8, 12, 24, 36, and 48)|The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.|||||
736287|NCT00440271|Secondary|Percentage of Participants Whose Viral Load <400 Copies/mL at Each Visit Including Visits at Weeks 24 and 48||after 2 weeks of treatment (Weeks 2, 4, 8, 12, 24, 36, and 48)|The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.|||||
736288|NCT00440271|Secondary|Percentage of Participants Whose Viral Load <50 Copies/mL at Each Visit Including Visits at Weeks 24 and 48||after 2 weeks of treatment (Weeks 2, 4, 8, 12, 24, 36, and 48)|The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.|||||
736289|NCT00440271|Primary|Treatment Response at Week 48|percentage of participants whose viral load <50 copies/mL at Week 48|after 48 weeks of treatment|The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.|||||
736290|NCT00440297|Primary|The Total Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences|Participants with adverse experiences considered possibly, probably, or definitely related to study vaccines and considered serious (death, persistent disability, life threatening, hospitalization, birth defects, cancer, or overdose).|0-9 months (recorded from first dose until the participant completes or discontinues the study)|Safety Analysis Set: The Safety Analysis Set is defined as all participants who receive at least one injection of vaccine and who had a safety follow-up||Participants|||Number
736291|NCT00440297|Primary|The Total Number of Participants With a Maximum Temperature >= 100.0F / 37.8C||Days 1-5 After Any Vaccination|Safety Analysis Set: The Safety Analysis Set is defined as all participants who receive at least one injection of vaccine and who had a safety follow-up||Participants|||Number
736292|NCT00440297|Primary|The Total Number of Participants With One or More Injection-Site Adverse Experiences||Days 1-15 After Any Vaccination|Safety Analysis Set: The Safety Analysis Set is defined as all participants who receive at least one injection of vaccine and who had a safety follow-up||Participants|||Number
736293|NCT00440297|Primary|The Number of Seroprotected Participants to the Modified Process Hepatitis B Vaccine and ENGERIX-B™ (Currently Licensed Vaccine) at Month 9|"The number of participants as measured by the
seroprotection rate (anti-hepatitis B surface antibodies greater than or equal to 10 mIU/mL). Anti-HBs (Antibodies against hepatitis B surface antigen) titers were measured from blood samples taken at Day 1 (prior to the first dose) and at Month 9 (1 month after the fourth dose)."|9 months (1 month after the fourth dose)|"Per-Protocol Population: The Per-
Protocol Population is defined as the participants that were able to complete the study as defined by the
protocol."||Participants|||Number
736294|NCT00440297|Primary|The Number of Seroprotected Participants to the Modified Process Hepatitis B Vaccine and ENGERIX-B™ (Currently Licensed Vaccine) at Month 7|"The number of participants as measured by the
seroprotection rate (anti-hepatitis B surface antibodies greater than or equal to 10 mIU/mL). Anti-HBs (Antibodies against hepatitis B surface antigen) titers were measured from blood samples taken at Day 1 (prior to the first dose) and at Month 7 (1 month after the third dose)."|7 months (1 month after the third dose)|Per-Protocol Population: The Per-Protocol Population is defined as the participants that were able to complete the study as defined by the protocol.||Participants|||Number
736295|NCT00440310|Primary|Overall Survival|Time from randomization to death|Up to 184 weeks|ITT (All patient randomized/enrolled)||Days||Inter-Quartile Range|Median
737776|NCT00454649|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) for Docetaxel||0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 5|Cmin was analyzed only for orally administered drugs.||ng/mL||Standard Deviation|Mean
736296|NCT00440401|Secondary|Proportion of Subjects Achieving Haemostasis at 6 Minutes.|Six minutes after application of trial treatment (TachoSil® or standard fleece material) the investigator evaluated if haemostasis in the target area was achieved.|6 minutes|"Three subjects were randomised to standard treatment but incorrectly received TachoSil® instead. All other subjects received the trial treatment to which they were randomised. The intention to treat (ITT) population was defined as randomised and the Safety population (= basis for Adverse Events analyses) was defined as treated."||Proportion of Subjects||95% Confidence Interval|Number
736297|NCT00440401|Primary|Proportion of Subjects Achieving Haemostasis at 3 Minutes|Three minutes after application of trial treatment (TachoSil® or standard fleece material) the investigator evaluated if haemostasis in the target area was achieved.|3 minutes|"Three subjects were randomised to standard treatment but incorrectly received TachoSil® instead. All other subjects received the trial treatment to which they were randomised. The intention to treat (ITT) population was defined as randomised and the Safety population (= basis for Adverse Events analyses) was defined as treated."||Proportion of Subjects||95% Confidence Interval|Number
736298|NCT00440466|Other Pre-specified|Number of Participants Who Died||36 weeks of treatment|||Participants|||Number
736299|NCT00440466|Other Pre-specified|Maximum Hemoglobin Rate of Rise in Grams Per Deciliter (g/dL/2 Weeks)||36 weeks of treatment|Safety population defined as all participants who received at least 1 injection of study drug||g/dL/2 weeks||Standard Deviation|Mean
736300|NCT00440466|Other Pre-specified|Participants Who Met or Exceeded 2.0 Grams Per Deciliter Per 2 Weeks (g/dL/2 Weeks) Hemoglobin Rates of Rise||36 weeks of treatment|Safety population defined as all participants who received at least 1 injection of study drug||Participants|||Number
736301|NCT00440466|Other Pre-specified|Participants Who Met or Exceeded 1.5 Grams Per Deciliter Per 2 Weeks (g/dL/2 Weeks) Hemoglobin Rates of Rise||36 weeks of treatment|||Participants|||Number
736302|NCT00440466|Other Pre-specified|Participants Who Met or Exceeded 1.0 Grams Per Deciliter Per 2 Weeks (g/dL/2 Weeks) Hemoglobin Rates of Rise||36 weeks of treatment|Safety population defined as all participants who received at least 1 injection of study drug||Particpants|||Number
736303|NCT00440466|Other Pre-specified|Maximum Hemoglobin Concentration in Grams Per Deciliter (g/dL)||36 weeks of treatment|Safety population defined as all participants who received at least 1 injection of study drug||g/dL||Standard Deviation|Mean
736304|NCT00440466|Other Pre-specified|Participants Who Exceeded a Hemoglobin Concentration of 11.9 Grams Per Deciliter (g/dL)||36 weeks of treatment|Safety population defined as all participants who received at least 1 injection of study drug||Participants|||Number
736305|NCT00440466|Secondary|Proportion of Weeks Per Patient With Hemoglobin Concentration Between 10.0 and 11.9 Grams Per Deciliter (g/dL)||Weeks 13-37|Modified Intent-To-Treat (mITT) population defined as all participants who were randomly assigned to treatment with epoetin alfa and had at least 1 post-randomization hemoglobin assessment.||Proportion||Full Range|Median
736306|NCT00440466|Primary|Change in Hemoglobin Concentration in Grams Per Deciliter (g/dL) From Baseline to the Average of the Last 12 Weeks of Treatment||from baseline (Week 1) to the last 12 weeks of treatment|Modified Intent-To-Treat (mITT) population defined as all participants who were randomly assigned to treatment with epoetin alfa and had at least 1 post-randomization hemoglobin assessment.||g/dL||Standard Deviation|Mean
736307|NCT00440505|Secondary|Nausea|Nausea assessment by patient reported on a numerical rating scale (NRS) with 0=no nausea and 10=extreme nausea.|1 day|This analysis was per protocol. Only data from those patients who returned the pain diaries with the above information to the research staff by mail were included in the analysis.||Units on a scale||Standard Deviation|Mean
736308|NCT00440505|Secondary|Number of Participants Who Reported an Increase in Daily Pain Medication Regime|Number of participants who reported increases in daily pain medication after treatment with each intervention compared to their normal daily pain medication regime.|1 day|This analysis was per protocol. Only data from those patients who returned the pain diaries with the above information to the research staff by mail were included in the analysis.||Participants|||Number
736309|NCT00440505|Secondary|Patient Self-assessment of Psychological Distress|Patient self-assessment of psychological distress in brief rating scale with no psychological distress=0 and maximum psychological distress=90.|1 day|This analysis was per protocol. One patient dropped out of the study before the third intervention period. This patient does not have data for the 10 mg nicotine patch.||Units on a scale||Standard Deviation|Mean
736310|NCT00440505|Primary|Pain Score|Pain assessment by patient reported in visual analog score (VAS) with 0=no pain and 10=worst pain.|1 day|This analysis was per protocol. One patient dropped out of the study before the third intervention period. This patient does not have data for the 10 mg nicotine patch.||Units on a scale||Standard Deviation|Mean
736311|NCT00440518|Secondary|Changes From Baseline in Improvement of Function and Reduction of Disability Using the Headache Impact Test (HIT-6)|Headache Impact Test (HIT-6™) consists of 6 items designed to measure the impact headaches have on a person’s ability to function. Scores from the 6 questions will be added to create a total score. Range of the total score is 36 to 78. Higher scores indicate a greater impact on the subject’s quality of life.|Baseline, last visit in the 17-week Trial Period|Of the 71 (Placebo), 70 (Lacosamide 100mg) and 74 (Lacosamide 300mg) subjects in the Full Analysis Set (must have Baseline and at least one post-Baseline efficacy value), 64, 66, and 66 subjects respectively are included in this summary.||Scores on a scale||Standard Deviation|Mean
736312|NCT00440518|Secondary|Number of Subjects Who Experience a 50 Percent or Greater Reduction From Baseline in Migraine Frequency During the Last 4 Weeks of the Maintenance Period.||Baseline, last 4 weeks of the 14-week Maintenance Period|Of the 72 (Placebo), 72 (Lacosamide 100mg) and 74 (Lacosamide 300mg) subjects randomized, 71, 70, and 74 subjects respectively are included in this summary based on the Full Analysis Set (must have Baseline and at least one post-Baseline efficacy value). This summary uses a Last Observation Carried Forward (LOCF) approach.||Participants|||Number
736313|NCT00440518|Secondary|Number of Subjects Who Experience a 50 Percent or Greater Reduction From Baseline in Migraine Frequency During the Entire 14-week Maintenance Period.||Baseline, Entire 14-week Maintenance Period|Of the 72 (Placebo), 72 (Lacosamide 100mg) and 74 (Lacosamide 300mg) subjects randomized, 71, 70, and 74 subjects respectively are included in this summary based on the Full Analysis Set (must have Baseline and at least one post-Baseline efficacy value). This summary uses a Last Observation Carried Forward (LOCF) approach.||Participants|||Number
736314|NCT00440518|Secondary|Change From Baseline in Mean Migraine Headache Rates During the Last 4 Weeks of the Maintenance Period||Baseline, last 4 weeks of the 14-week Maintenance Period|Of the 72 (Placebo), 72 (Lacosamide 100mg) and 74 (Lacosamide 300mg) subjects randomized, 71, 70, and 74 subjects respectively are included in this summary based on the Full Analysis Set (must have Baseline and at least one post-Baseline efficacy value). This summary uses a Last Observation Carried Forward (LOCF) approach.||Number of migraine headaches||Standard Deviation|Mean
736315|NCT00440518|Primary|Change From Baseline in Mean Migraine Headache Rates During the Entire 14-week Maintenance Period||Baseline, Entire 14-week Maintenance Period|Of the 72 (Placebo), 72 (Lacosamide 100mg) and 74 (Lacosamide 300mg) subjects randomized, 71, 70, and 74 subjects respectively are included in this summary based on the Full Analysis Set (must have Baseline and at least one post-Baseline efficacy value). This summary uses a Last Observation Carried Forward (LOCF) approach.||Number of migraine headaches||Standard Deviation|Mean
736316|NCT00440531|Secondary|The Total Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences||During Entire Study Period (from first vaccination until the participant completes or discontinues: up to 7 months)|Safety Analysis Set – defined as all participants who received at least one injection of vaccine and who had a safety follow-up.||Participants|||Number
736317|NCT00440531|Secondary|The Total Number of Participants With a Maximum Temperature >=100.0F/37.8C||Day 1-5 After Vaccination|Safety Analysis Set - defined as all participants who received at least one injection of vaccine and who had a safety follow-up.||Participants|||Number
736318|NCT00440531|Secondary|The Total Number of Participants With One or More Injection-site Adverse Experiences||Days 1-5 After Any Vaccination|Safety Analysis Set – defined as all participants who received at least one injection of vaccine and who had a safety follow-up.||Participants|||Number
736319|NCT00440531|Secondary|The Number of Seroresponders to ENGERIX-B™ (Currently Licensed Vaccine)|The number of participants as measured by the seroprotection rate (anti-hepatitis B surface antibodies greater than or equal to 10 mIU/mL). Anti-HBs (Antibodies against hepatitis B surface antigen) titers were measured from blood samples taken at Day 1 (prior to the first vaccination) and at Month 7 (1 month after the third vaccination).|7 months (1 month after third vaccination)|Per-protocol Population. The Per-protocol Population is defined as the participants that were able to complete the study as defined by the protocol.||Participants|||Number
736320|NCT00440531|Primary|The Number of Seroresponders to the Modified Process Hepatitis B Vaccine and RECOMBIVAX HB™ (Currently Licensed Vaccine)|The number of participants as measured by the seroprotection rate (anti-hepatitis B surface antibodies greater than or equal to 10 mIU/mL). Anti-HBs (Antibodies against hepatitis B surface antigen) titers were measured from blood samples taken at Day 1 (prior to the first vaccination) and at Month 7 (1 month after the third vaccination).|7 months (1 month after third vaccination)|Per-protocol Population. The Per-protocol Population is defined as the participants that were able to complete the study as defined by the protocol.||Participants|||Number
736321|NCT00441441|Post-Hoc|Geometric Mean Ratio for Baseline: Week 12 24-hour Urinary Cortisol Excretion by Spacer Use Excluding Participants With Abnormal Urinary Cortisol Excretion Values at Baseline From the Cortisol Population|AeroChamber Plus spacers were provided for participants who demonstrated the inability to coordinate the use of an Meter Dose Inhaler at Visit 1. AeroChamber Plus spacer delivers 22% more medication than the original AeroChamber and is available in three mask sizes and without a mask. The data provided are a direct calculation of the Week 12 geometric mean divided by the baseline value,nanomoles per 24 hours (nmol/24 hrs) .|Baseline and Week 12|Cortisol Population||ratio|||Number
736322|NCT00441441|Post-Hoc|Geometric Mean Values of 24-hour Urinary Cortisol Excretion by Spacer Use Excluding Participants With Abnormal Urinary Cortisol Excretion Values at Baseline From the Cortisol Population at Baseline and Week 12|AeroChamber Plus spacers were provided for participants who demonstrated the inability to coordinate the use of an Meter Dose Inhaler at Visit 1. AeroChamber Plus spacer delivers 22% more medication than the original AeroChamber and is available in three mask sizes and without a mask. Geometric mean is the product of the values taken to the Nth root, where N is the number of values in the set of values.|Baseline and Week 12|Cortisol Population||Nanomoles per 24 hr (nmoles/24 hr)||Full Range|Geometric Mean
736323|NCT00441441|Post-Hoc|Geometric Mean Ratio for Baseline:Week12 24-hour Urinary Cortisol Excretion|A post-hoc analysis excluding participants with urine cortisol baseline values of >200 nmol/24 hrs. The data provided are a direct calculation of the Week 12 geometric mean divided by the baseline value, nanomoles per 24 hours (nmol/24 hrs) .|Baseline and Week 12|Cortisol Population||ratio|||Number
736324|NCT00441441|Post-Hoc|Geometric Mean Values of 24-hour Urinary Cortisol Excretion at Baseline and Week 12|A post-hoc analysis excluding participants with urine cortisol baseline values of >200 nanomoles/24 hours. Geometric mean is the product of the values taken to the Nth root, where N is the number of values in the set of values.|Baseline and Week 12|Cortisol Population||Nanamoles per 24 hours (nmol/24 hrs)||Full Range|Geometric Mean
736325|NCT00441441|Secondary|Percent of Albuterol-free Days|Percentage of days when Albuterol use was unnecessary based on daily record and symptom free days.|Baseline and 12-Week Treatment Period|Participants from the ITT population (not necessarily selected to show efficacy differences). Total numbers of participants analyzed for the Fluticasone propionate (FP)/salmeterol HFA and FP groups, respectively, were 168 and 174 at baseline; 166 and 172 at Weeks 1-12; and 157 and 165 for the last 7 days on treatment.||Percentage of days||Standard Error|Mean
736326|NCT00441441|Secondary|Albuterol Use|Albuterol inhalation aerosol was used as a rescue or prophylactic and recorded daily by subject or caregiver. The number of puffs of albuterol over the previous 24 hour period prior to dosing was recorded.|Baseline and 12-Week Treatment Period|Participants from the ITT population (not necessarily selected to show efficacy differences). Total numbers of participants analyzed for the Fluticasone propionate (FP)/salmeterol HFA and FP groups, respectively, were 168 and 174 at baseline; 166 and 172 at Weeks 1-12; and 157 and 165 for the last 7 days on treatment.||Number of puffs per 24 hours||Standard Error|Mean
736349|NCT00441480|Secondary|Apolipoprotein A|Blood test on day 0|at baseline|Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points||mg/dl||Standard Deviation|Mean
736327|NCT00441441|Secondary|Percentage of Symptom Free Days|Percentage of number of days without asthma symptoms based on Asthma Symptom Scores. Each morning prior to dosing or PEF, asthma symptoms were self-scored based on the past 24 hours: 0=no symptoms, 1=symptoms for one short period, 2=symptoms for two or more short periods, 3=frequent symptoms that did not affect activities of daily living (ADL), 4=frequent .|Baseline and 12-Week Treatment Period|Participants from the ITT population (not necessarily selected to show efficacy differences). Total numbers of participants analyzed for the Fluticasone propionate (FP)/salmeterol HFA and FP groups, respectively, were 173 and 175 at baseline; 172 and 174 at Weeks 1-12; and 167 and 170 for the last 7 days on treatment.||Percentage of days||Standard Error|Mean
736328|NCT00441441|Secondary|Asthma Symptom Scores|Each morning prior dosing or PEF, self-scored based on past 24 hours: 0=No symptoms, 1=Symptoms for one short period, 2=Symptoms for two or more short periods, 3=Frequent Symptoms which did not affect activities of daily living (ADL), 4=Frequent.|Baseline and 12-Week Treatment Period|Participants from the ITT population (not necessarily selected to show efficacy differences). Total numbers of participants analyzed for the Fluticasone propionate (FP)/salmeterol HFA and FP groups, respectively, were 173 and 175 at baseline; 172 and 174 at Weeks 1-12; and 167 and 170 for the last 7 days on treatment.||Score in scale||Standard Error|Mean
736329|NCT00441441|Secondary|AM Peak Expiratory Flow|The peak expiratory flow (PEF) rate measures how fast a person can exhale air. It is used to compare to normal flow rates to predict obstruction and disease. The average PEF for a child or adolescent whose height is 43 inches is 147 Liters/minute (L/min), whose height is 66 inches is 454 L/min. Triplicate measurements taken for the best effort recorded.|Baseline and 12-Week Treatment Period|Participants from the ITT Population (not necessarily selected to show efficacy differences). Total numbers of participants analyzed for the Fluticasone propionate (FP)/salmeterol HFA and FP groups, respectively, were 173 and 175 at baseline; 173 and 174 at Weeks 1-12; and 171 and 173 for the last 7 days on treatment.||Liters/minute (L/min)||Standard Error|Mean
736330|NCT00441441|Secondary|Clinic Morning (AM) Forced Expiratory Volume in Participants 6-11 Years|"FEV1 (Forced Expiratory Volume in 1 second) is the volume of air that can be forced out in one second, after taking a deep breath. FEV1 is measured using a spirometer and obtaining best effort from 3 to 8 measurements. Week 12 is the measure taken at Week 12."|Baseline and week 12|Subset of ITT Population: Participants who were 6-11 years of age (population not necessarily selected to show efficacy differences). Total numbers of participants analyzed for the Fluticasone propionate (FP)/salmeterol HFA and FP groups, respectively, were 137 and 136 at baseline; 126 and 124 at Week 12, and 6 and 7 at premature discontinuation.||Liters per second (L/sec)||Standard Error|Mean
736331|NCT00441441|Primary|Geometric Mean Ratio for Week12: Baseline for 24 Hour Urinary Cortisol Excretion by Spacer Use|AeroChamber Plus spacers were provided for participants who demonstrated the inability to coordinate the use of an Meter Dose Inhaler at Visit 1. AeroChamber Plus spacer delivers 22% more medication than the original AeroChamber and is available in three mask sizes and without a mask. The data provided are a direct calculation of the Week 12 geometric mean divided by the baseline value, nanomoles per 24 hours (nmol/24 hrs).|Baseline and Week 12|Cortisol Population||ratio|||Number
736332|NCT00441441|Primary|Geometric Mean Values of 24 Hour Urinary Cortisol Excretion by Spacer Use at Baseline and Week 12|AeroChamber Plus spacers were provided for participants who demonstrated the inability to coordinate the use of an Meter Dose Inhaler at Visit 1. AeroChamber Plus spacer delivers 22% more medication than the original AeroChamber and is available in three mask sizes and without a mask. Geometric mean is the product of the values taken to the Nth root, where N is the number of values in the set of values.|Baseline and Week 12|Cortisol Population||Nanomoles per 24 hours (nmol/24 hrs)||Full Range|Geometric Mean
736333|NCT00441441|Primary|Number of Participants With the Indicated Levels of 24 Hour Urinary Cortisol Excretion by Spacer Use|"AeroChamber Plus spacers were provided for participants who demonstrated the inability to coordinate the use of an Meter Dose Inhaler at Visit 1. AeroChamber Plus spacer delivers 22% more medication than the original AeroChamber and is available in three mask sizes and without a mask. Abnormal high cortisol excretion and Abnormal low cortisol excretion are defined as above the upper limit of normal and below the lower limit of normal, respectively. An abnormality is defined as a value of 24-hour urinary cortisol excretion that is outside the normal range. The normal range for 24-hour urinary cortisol excretion was provided by the central laboratory."|Baseline and Week 12|Cortisol Population||participants|||Number
736334|NCT00441441|Primary|Geometric Mean Ratio for Week12:Baseline for 24-hour Urinary Cortisol Excretion|Normal range for Cortisol levels vary by age and gender. The data provided are a direct calculation of the Week 12 geometric mean divided by the baseline value, nanomoles per 24 hours (nmol/24 hrs).|Baseline and Week 12|Cortisol Population||ratio|||Number
736335|NCT00441441|Primary|Geometric Mean Values of 24-hour Urinary Cortisol Excretion at Baseline and Week 12|Normal range for Cortisol levels vary by age and gender. Geometric mean is the product of the values taken to the Nth root, where N is the number of values in the set of values.|Baseline and Week 12|Cortisol Population||Nanomoles per 24 hours (nmol/24 hrs)||Full Range|Geometric Mean
736336|NCT00441441|Primary|Number of Participants With the Indicated Levels of 24-hour Urinary Cortisol Excretion|"Abnormal high cortisol excretion and Abnormal low cortisol excretion are defined as above the upper limit of normal and below the lower limit of normal, respectively. The normal range for cortisol levels vary by age and gender. An abnormality is defined as a value of 24-hour urinary cortisol excretion that is outside the normal range. The normal range for 24-hour urinary cortisol excretion was provided by the central laboratory."|Baseline and week 12|Cortisol Population - all participants not excluded due to the following reasons: missing data, use of protocol-specified corticosteroids (prior to screening), collection time outside of 24 ± 2 hours, use of inhaled cortical steroid (ICS) during treatment, and who stopped study medication >1 day prior to start of post-baseline urine collection.||participants|||Number
736350|NCT00441480|Secondary|Apolipoprotein B100|Blood test results follwing 12 weeks of intervention|12 weeks|Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points||mg/dl||Standard Deviation|Mean
736351|NCT00441480|Secondary|Apolipoprotein B100|Blood test results on day 0|at baseline|Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points||mg/dl||Standard Deviation|Mean
736337|NCT00441441|Primary|Asthma Exacerbations: Worsening of Asthma Requiring Emergency Intervention, Hospitalization, or Treatment With Asthma Medications Prohibited by the Protocols|The Primary Investigator determined the severity of the exacerbation based on the participant’s clinical presentation and the investigator’s understanding of the disease, the participant, and his or her clinical experiences. The severity of the exacerbation was not defined in the protocol. Mild: Usually treated at home. Prompt relief with inhaled short-acting beta2 agonist. Possible short course of oral systemic corticosteroids. Moderate: Usually requires office or emergency department visit. Relief with frequent inhaled short-acting beta2 agonist. Oral systemic corticosteroids; some symptoms last for 1-2 days after treatment begins. Severe: Usually requires emergency department visit and likely hospitalization. Partial relief with frequent inhaled short-acting beta2 agonist. Oral systemic corticosteroids; some symptoms last for more than 3 days after treatment begins. Adjunctive therapies are helpful.|Treatment period (weeks 1-12)|ITT Population - All participants who were randomized and received at least one dose of double-blind study treatment.||participants|||Number
736338|NCT00441441|Primary|Cardiovascular Adverse Events Reported During the Post-Treatment Period|Cardiovascular Adverse Events, as categorized by the Medical Dictionary for Regulatory Activities (MeDRA), reported during Post-treatment period, defined as 1 day after last dose of study drug. The Adverse Events were identified in any ECG interpretation by a central reader (Cardiologist) for any ECG obtained after the first treatment dose and were then reported by the Primary Investigator as an Adverse Event.|5 Days after Week 12|ITT Population - All participants who were randomized and received at least one dose of double-blind study treatment.||participants|||Number
736339|NCT00441441|Primary|Cardiovascular Adverse Events Reported During Treatment Period|Cardiovascular Adverse Events, as categorized by the Medical Dictionary for Regulatory Activities (MeDRA), reported during Treatment Period. The Adverse Events were identified in any ECG interpretation by a central reader (Cardiologist) for any ECG obtained after the first treatment dose and were then reported by the Primary Investigator as an Adverse Event. Please see the category titles for a list of candidate cardiovascular adverse events.|12-Week Treatment Period|ITT Population - All participants who were randomized and received at least one dose of double-blind study treatment.||participants|||Number
736340|NCT00441441|Primary|ECG Measures - QT Interval|Fridericia’s formula QTc interval=QT interval/cubed root of the R-R interval. The Bazett’s formula QTc=QT/squared root of the R-R interval.|Baseline and Week 12|ITT Population - All participants who were randomized and received at least one dose of double-blind study treatment.||milliseconds||Full Range|Mean
736341|NCT00441441|Primary|ECG Measures – Heart Rate|The range of heart rates for this study was between 49-144 beats per minute|Baseline and Week 12|ITT Population - All subjects who were randomized and received at least one dose of double-blind study treatment.||beats per minute||Full Range|Mean
736342|NCT00441441|Primary|Clinically Significant Unfavorable ECGs at Week 12|Post-randomization ECGs categorized by the primary investigator as no change, significant change (favorable), significant change (unfavorable) from the ECG performed at Visit 1 (Baseline) are presented. Significant change (favorable) includes any ECG that improved from baseline, whereas significant change (unfavorable) includes any ECG that worsened from baseline. Clinical significance is determined by the primary investigator.|Baseline, Week 12|ITT Population. The number of participants at baseline was 173 and 177, respectively, for the Fluticasone propionate/salmeterol HFA and Fluticasone Propionate (FP) HFA groups. The numbers of participants at Week 12 were 162 and 160, respectively. Data for 6 participants in the FP treatment arm were either not obtained or not evaluable.||participants|||Number
736343|NCT00441441|Primary|Investigator Evaluations of Electrocardiogram (ECG) Results|ECGs were transmitted to an independent cardiologist who was responsible for providing interpretation of the ECG as either normal or abnormal (based on personal assessment). The investigator was then responsible for determining the clinical significance of the abnormal ECG in the context of the participants’ history and clinical presentation. An abnormal, clinically significant ECG included, but was not limited to: prolonged QT interval, ischemic changes, ventricular hypertrophy, intraventricular conduction abnormalities, and clinically significant arrhythmias. PD, premature discontinuation.|Baseline and Week 12|ITT Population. The number of participants at baseline was 173 and 177, respectively, for the Fluticasone propionate/salmeterol HFA and Fluticasone Propionate (FP) HFA groups. The number of participants at Week 12 was 162 and 160, respectively. Data for 6 participants in the FP treatment arm were either not obtained or not evaluable.||participants|||Number
736344|NCT00441441|Primary|Possible Drug-Related Adverse Events|Adverse Events reported by the Investigator and judged by the Investigator to be possibly related to study drug, categorized by the Medical Dictionary for Regulatory Activities (MeDRA), were reported. ECG, electrocardiogram. QTc (corrected QT interval) and QT represent intervals on an ECG.|Treatment period (weeks 1-12) and Post Treatment (≥1 day after last time study drug)|Intent-to-Treat (IITT) Population - All participants who were randomized and received at least one dose of double-blind study treatment.||participants|||Number
736345|NCT00441467|Secondary|Overall Survival||All subjects were followed regularly until glufosfamide discontinuation, tumor progression or additional antitumor therapy was started and then were followed for survival at 3 month intervals for the first year and once every year thereafter until death.|||months||95% Confidence Interval|Median
736346|NCT00441467|Secondary|Progression-free Survival||All subjects were followed regularly until glufosfamide discontinuation, tumor progression or additional antitumor therapy was started and then were followed for survival at 3 month intervals for the first year and once every year thereafter until death.|||months||95% Confidence Interval|Median
736347|NCT00441467|Primary|Objective Response Rate|The event rate was the response rate (complete and partial response) based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.0). The associated 95% exact binomial confidence intervals were calculated.|Tumor assessments were performed at baseline and every 6 weeks until disease progression was documented.|Patients receiving glufosfamide with a post treatment imaging assessment||participants|||Number
736348|NCT00441480|Secondary|Apolipoprotein A|Blood test results following 12 weeks of intervention|12 weeks|Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points||mg/dl||Standard Deviation|Mean
736352|NCT00441480|Secondary|CRP|Blood test results following 12 weeks of intervention of High sensetivity C reactive protein|12 weeks|Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points||mg/l||Standard Deviation|Mean
736353|NCT00441480|Secondary|CRP|Blood test results on day 0 of High sensitivity C Reactive Protein|at baseline|Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points||mg/l||Standard Deviation|Mean
736354|NCT00441480|Secondary|HDL-cholestrol|Blood test results following 12 weeks of intervention|12 weeks|Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points||mg/dl||Standard Deviation|Mean
736355|NCT00441480|Primary|LDL-C|Blood test results following 12 weeks of intervention|12 weeks|Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points||md/dl||Standard Deviation|Mean
736356|NCT00441480|Secondary|HDL Cholesterol|Average of blood test results at -10 and 0 weeks (before and after run-in period)|at baseline|Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points||mg/dl||Standard Deviation|Mean
736357|NCT00441480|Secondary|Total Cholesterol|Blood test results following 12 weeks of intervention|12 weeks|Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points||mg/dl||Standard Deviation|Mean
736358|NCT00441480|Secondary|Total Cholesterol|Average of blood test results at -10 and 0 weeks (before and after run-in period)|at baseline|Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points||mg/dl||Standard Deviation|Mean
736359|NCT00441480|Secondary|Triglycerides|Blood test results following 12 weeks of intervention|12 weeks|Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points||mg/dl||Standard Deviation|Mean
736360|NCT00441480|Secondary|Triglycerides|Average of blood test results at -10 and 0 weeks (before and after run-in period)|at baseline|Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points||mg/dl||Standard Deviation|Mean
736361|NCT00441480|Primary|LDL Cholesterol|Average of blood test results at -10 and 0 days (before and after run-in period)|at baseline|Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points||mg/dl||Standard Deviation|Mean
736362|NCT00441545|Secondary|Patients Achieving Kidney Disease Outcomes Quality Initiative (KDOQI) Target for Serum Phosphorous at 4 Weeks|Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum phosphorous is 3.5 - 5.5 mg/dL (1.13 - 1.77 mmol/L)|4 weeks|||Percentage of Participants|||Number
736363|NCT00441545|Secondary|Levels of Intact Parathyroid Hormone (iPTH) at Baseline and 4 Weeks||Baseline and 4 weeks|ITT||pg/mL||Standard Error|Mean
736364|NCT00441545|Secondary|Change From Baseline in Serum Calcium Levels at 4 Weeks||4 weeks|ITT||mg/dL||Standard Error|Least Squares Mean
736365|NCT00441545|Primary|Change From Baseline in Serum Phosphorus Levels at 4 Weeks||4 weeks|ITT population defined as subjects who were randomized, received at least one dose of investigational product, and had at least one post-dose assessment of the primary efficacy variable.||mg/dL||Standard Error|Least Squares Mean
736366|NCT00441558|Primary|The Frequency of Adverse Events (Side Effects).|This is a 52-week, open label trial assessing safety/tolerability of flibanserin in women with Hypoactive Sexual Desire Disorder|52 weeks|||participants with any adverse event|||Number
736367|NCT00441584|Primary|Number of Subjects Who Have Achieved Sustained Virological Response (SVR) at 24 Weeks Post End of Treatment|Sustained virologic response is defined as a plasma HCV RNA level below Lower Level of Quantitation at 24 weeks post-treatment, which is < 30 IU/mL in this study.|Up to 48 weeks of treatment plus 24 weeks follow up|The All Treated population included all subjects who took at least one dose of study medication.||Participants|||Number
736368|NCT00441701|Secondary|Part 2: Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Individual/Total Domains|SGRQ consists of 76 items aggregated into 3 domain scores: Symptoms (frequency/severity), Activity (cause or limited by breathlessness), Impact (social functioning, psychological disturbances from airway disease), and total score. Participants were to assess their symptoms, activity and impact at Baseline and Week 12.|Baseline and Week 12|The population was to consist of all Part 2 participants who were randomized, received at least one dose of study drug and had a Baseline and Week 12 efficacy assessment for SGRQ. Part 2 of this study was not conducted under this protocol.|||||
736369|NCT00441701|Secondary|Part 2: Change From Baseline in Individual Symptom Scores|Participants were to be assessed for individual symptom scores at Baseline and Week 12 using the following scales: Sputum Production (0=none, unaware of any sputum production to 4=severe, an almost constant problem), Cough (0=none, unaware of coughing to 4=severe, never free of cough or need to cough), and Dyspnea (0=none, unaware of any difficulty to 4=severe, almost constant: present even when resting).|Baseline and Week 12|The population was to consist of all Part 2 participants who were randomized, received at least one dose of study drug and had a Baseline and Week 12 efficacy assessment for individual symptom scores. Part 2 of this study was not conducted under this protocol.|||||
736370|NCT00441701|Secondary|Part 2: Change From Baseline in Induced Sputum Percent Neutrophil Count|Sputum neutrophils were to be measured as percent of total white blood cells. Participants were to be assessed for induced sputum percent neutrophil counts via the nebulized method at Baseline and at Week 12.|Baseline and Week 12|The population was to consist of all Part 2 participants who were randomized, received at least one dose of study drug and had a Baseline and Week 12 assessment for sputum percent neutrophil count. Part 2 of this study was not conducted under this protocol.|||||
736371|NCT00441701|Secondary|Part 2: Change From Baseline in Induced Sputum Absolute Neutrophil Count|Participants were to be assessed for induced sputum absolute neutrophil counts via the nebulized method at Baseline and at Week 12.|Baseline and Week 12|The population was to consist of all Part 2 participants who were randomized, received at least one dose of study drug and had a Baseline and Week 12 assessment for induced sputum absolute neutrophil count. Part 2 of this study was not conducted under this protocol.|||||
736372|NCT00441701|Secondary|Part 2: Change From Baseline in Peak Expiratory Flow (PEF)|PEF, as measured in liters/minute via peak flow meter, is the maximum speed of expiration. Participants were to measure their PEF in triplicate every morning before taking study drug and again every evening.|Baseline and Week 12|The population was to consist of all Part 2 participants who were randomized, received at least one dose of study drug, and had a Baseline and Week 12 efficacy assessment for PEF. Part 2 of this study was not conducted under this protocol.|||||
736373|NCT00441701|Secondary|Part 2: Number of Participants Who Experience a COPD Exacerbation|COPD exacerbation is defined as any change in symptoms or functional status that leads to administration of systemic corticosteroids, antibiotics, an emergency room visit or a hospitalization. The number of participants who experienced a COPD exacerbation was to be summarized.|Up to Week 12|The population was to consist of all Part 2 participants who were randomized, received at least one dose of study drug, and had a at least one post-Baseline assessment for presence of COPD exacerbation. Part 2 of this study was not conducted under this protocol.|||||
736374|NCT00441701|Secondary|Part 2: Change From Baseline in Functional Residual Capacity (FRC)|FRC, as measured in liters via body plethysmography, is the volume of air present in the lungs, specifically the parenchyma tissues, at the end of passive expiration. Participants were to be assessed for FRC at Baseline and Week 12.|Baseline and Week 12|The population was to consist of all Part 2 participants who were randomized, received at least one dose of study drug, and had a Baseline and Week 12 efficacy assessment for FRC. Part 2 of this study was not conducted under this protocol.|||||
736375|NCT00441701|Secondary|Part 2: Change From Baseline in FVC|FVC, as measured in liters via spirometry, is the amount of air forcibly exhaled from the lungs after taking the deepest breath possible. Post-bronchodilator FVC was to be assessed 30 minutes after bronchodilator administration at Baseline and Week 12.|Baseline and Week 12|The population was to consist of all Part 2 participants who were randomized, received at least one dose of study drug, and had a Baseline and Week 12 efficacy assessment for FVC. Part 2 of this study was not conducted under this protocol.|||||
736376|NCT00441701|Secondary|Part 2: Change From Baseline in Forced Expiratory Flow During Middle Half of Forced Vital Capacity (FVC) (FEF25%-75%)|Mid-Breath Forced Expiratory Flow (FEF25%-75%), as measured in liters/minute via spirometry, is the rate at which participants breathe out air from 25 percent of their breath to 75 percent of their breath. Participants were to be assessed for FEF25%-75% at Baseline and Week 12.|Baseline and Week 12|The population was to consist of all Part 2 participants who were randomized, received at least one dose of study drug, and had a Baseline and Week 12 assessment for FEF25%-75%. Part 2 of this study was not conducted under this protocol.|||||
736377|NCT00441701|Secondary|Part 2: Change From Baseline in Post-Bronchodilator FEV1|FEV1, as measured in liters via spirometry, is a measure of the amount of air expired in 1 second. Participants were to be assessed for post-bronchodilator FEV1 30 minutes after dosing with bronchodilator (albuterol sulfate or equivalent) (reversibility test) at Baseline and Week 12. Post-bronchodilator data were to be averaged weekly over the 12-week treatment period for analysis.|Baseline and the Average over 12 weeks|The population was to consist of all Part 2 participants who were randomized, received at least one dose of study drug, and had a Baseline and Week 12 efficacy assessment for post-bronchodilator FEV1. Part 2 of this study was not conducted under this protocol.|||||
736378|NCT00441701|Secondary|Part 1: Change From Baseline in Sputum Percent Neutrophil Count (Induced Sputum)|Sputum neutrophils were to be measured as percent of total white blood cells. Participants were to be assessed for induced sputum percent neutrophil counts via the nebulized method at Baseline and at Week 12.|Baseline and Week 12|The population was to consist of all Part 1 participants who were randomized, received at least 1 dose of study drug, and had a Baseline and Week 12 assessment for sputum percent neutrophil count. Since sufficient data for analysis were collected for absolute sputum neutrophil count, percent sputum neutrophil count was not assessed.|||||
736379|NCT00441701|Secondary|Part 1: Change From Baseline in Sputum Absolute Neutrophil Count (Induced Sputum)|Participants were assessed for induced sputum absolute neutrophil counts via the nebulized method at Baseline and at Week 12. The reported SDs are pooled across all treatment groups. The rationale for the use of an ANOVA method using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline and Week 12|The population consisted of all Part 1 participants who were randomized, received at least one dose of study drug, and had a Baseline and Week 12 assessment for induced sputum absolute neutrophil count.||10^9 cells/L||Standard Deviation|Mean
736380|NCT00441701|Secondary|Part 1: Change From Baseline in Percent PBN Count|Participants were to be assessed for percent PBN counts at Baseline and at Week 12.|Baseline and Week 12|The population was to consist of all Part 1 participants who were randomized, received at least one dose of study drug, and had a Baseline and a Week 12 assessment for percent PBN count. Since sufficient data for analysis were collected for absolute PBN count, percent PBN count was not assessed.|||||
736381|NCT00441701|Primary|Part 2: Change From Baseline in Daily Morning/Nighttime Sputum Production, Cough, and Dyspnea (SCDS) Score|Participants were to assess their morning (AM) and nighttime (PM) COPD symptoms (sputum production, cough, and dyspnea) on a daily basis in their e-Diaries. Baseline SCDS was defined as the average of AM and PM values over the week prior to and including Day 1 (AM) prior to the first dose of study drug. SCDS data were to be averaged weekly over the 12-week treatment period for analysis.|Baseline and the Average over 12 weeks|The population was to consist of all Part 2 participants who were randomized, received at least one dose of study drug, and had a Baseline and at least one post-Baseline assessment for AM/PM SCDS scores. Part 2 of this study was not conducted under this protocol.|||||
736382|NCT00441701|Primary|Part 2: Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)|FEV1, as measured in liters via spirometry, is a measure of the amount of air expired in 1 second. Participants were to be assessed for pre-bronchodilator FEV1 immediately before dosing with bronchodilator (albuterol sulfate or equivalent) at Baseline and at Week 12. Pre-bronchodilator FEV1 data were to be averaged weekly over the 12-week treatment period for analysis.|Baseline and the Average over 12 weeks|The population was to consist of all Part 2 participants who were randomized, received at least one dose of study drug, and had a Baseline and at least one post-Baseline assessment for FEV1. Part 2 of this study was not conducted under this protocol.|||||
736383|NCT00441701|Primary|Part 1: Change From Baseline in Absolute Peripheral Blood Neutrophil (PBN) Count|Participants were assessed for absolute PBN counts at Baseline and Week 12. The reported standard deviations (SDs) are pooled across all treatment groups. The rationale for the use of an analysis of variance (ANOVA) method using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline and Week 12|The population consisted of all Part 1 participants who were randomized and received at least one dose of study drug and had a Baseline and a Week 12 assessment for absolute PBN count.||10^9 cells/L||Standard Deviation|Mean
736384|NCT00441701|Primary|Part 1: Number of Participants Who Discontinue Study Drug Due to an AE|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment. AEs may include the onset of new illness and the exacerbation of pre-existing conditions. The number of participants who discontinued study drug, whether permanently or temporarily, due to an AE was summarized.|Up to 12 weeks|The population consisted of all Part 1 participants who were randomized and received at least one dose of study drug.||Participants|||Number
736385|NCT00441701|Primary|Part 1: Number of Participants Who Experience at Least One Adverse Event (AE)|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment. AEs may include the onset of new illness and the exacerbation of pre-existing conditions. The number of participants who experienced an AE, regardless of causality or severity, was summarized.|Up to 12 weeks|The population consisted of all Part 1 participants who were randomized and received at least one dose of study drug.||Participants|||Number
736386|NCT00441727|Secondary|Number of Participants With Gastric and/or Duodenal Erosions.||The number of erosions was determined by endoscopy performed at baseline, 8 weeks and 26 weeks or upon withdrawal.|Patients randomized who had endoscopy performed at baseline, 8 weeks and 26 weeks or upon withdrawal.||participants|||Number
736387|NCT00441727|Secondary|Number of Participants Reporting 0 in the Dichotomized RDQ (Reflux and Disease Questionnaire) Score (0 Versus >0) for the Gastroesophageal Reflux Disease Dimension During the 26-week Visit or the Week Prior to the Last Visit.|RDQ contains 12 items on a 6-point Likert scale. Six items concern the frequency ('Did not have' to 'Daily') and six items concern the severity ('Did not have' to 'Severe'). Gastroesophageal reflux disease (GERD) items: 'Acid taste in the mouth', 'Unpleasant movement of materials upward from the stomach', 'Burning feeling behind the breastbone' and 'Pain behind the breastbone'. Best score possible 0, worst score possible - daily occurrence.|RDQ was assessed at baseline, 8 weeks, 16 week, 26 weeks or upon withdrawal.|Patients randomized who took at least one dose of study drug and completed RDQ questionnaire at baseline and at week 26 or the week prior to last visit were analyzed.||participants|||Number
736388|NCT00441727|Secondary|Number of Participants Reporting 0 in the Dichotomized RDQ (Reflux and Disease Questionnaire) Score (0 Versus >0) for the Dyspepsia Dimension During the 26-week Visit or the Week Prior to the Last Visit.|RDQ contains 12 items on a 6-point Likert scale. Six items concern the frequence ('Did not have' to 'Daily') and six items concern the severity ('Did not have' to 'Severe'). The dyspepsia dimension contains the items 'Burning feeling in the center of the upper stomach' and 'Pain in the center of the upper stomach'. Best score possible 0, worst score possible - daily occurrence.|RDQ was assessed at baseline, 8 weeks, 16 week, 26 weeks or upon withdrawal.|Patients randomized who took at least one dose of study drug and completed RDQ questionnaire at baseline and at week 26 or the week prior to last visit were analyzed.||participants|||Number
736389|NCT00441727|Secondary|Percentage of Participants Who Experienced the Occurrence of Duodenal Ulcer.|The occurrence of duodenal ulcer (mucosal break measuring >= 3 mm over its largest diameter with a sharply demarcated margin) was determined by endoscopy performed at baseline, 8 weeks and 26 weeks or upon withdrawal.|During 26 weeks|||percentage of participants|||Number
736390|NCT00441727|Secondary|Percentage of Participants Who Experienced the Occurence of Gastric Ulcer.|The occurrence of gastric ulcer (mucosal break measuring >= 3 mm over its largest diameter with a sharply demarcated margin) was determined by endoscopy performed at baseline, 8 weeks and 26 weeks or upon withdrawal.|During 26 weeks|||percentage of participants|||Number
736391|NCT00441727|Primary|Percentage of Participants Who Experienced the Occurence of Peptic Ulcer(s).|The occurrence of ulcer (mucosal break measuring >= 3 mm over its largest diameter with a sharply demarcated margin) was determined by endoscopy performed at baseline, 8 weeks and 26 weeks or upon withdrawal.|During 26 weeks|||percentage of participants|||Number
736392|NCT00441766|Secondary|Change From Baseline in Frequency of Bowel Movements at Week 4 Using the Bristol Stool Scale (BSS)|Change from baseline in the frequency of bowel movements per day using the BSS. The BSS categorizes stool based on the patient's description of its consistency. Patients are classified into 3 IBS subtypes according to their predominant stool patterns (C=constipation; D=diarrhea; M=mixed). A positive change from baseline in the IBS-C indicates improvement and a negative change from baseline in the IBS-D and IBS-M indicates improvement.|Baseline, Week 4|Modified Intent-To-Treat (m-ITT). The m-ITT population included all patients who started the study (randomized), who received the study medication and had at least one post-baseline mean highest-average-pain score.||Bowel Movements (Stools) Per Day||Standard Deviation|Mean
736406|NCT00442013|Secondary|Asthma Symptom Utility Index (ASUI)|ASUI is a utility score that ranges from 0 to 1, with higher values indicating better asthma control; info obtained from questionnaire about asthma symptoms; number presents an average of the change from baseline to all follow-up points|Measured at Weeks 0, 4, 8, 12, 16, 20, 24|||score||95% Confidence Interval|Mean
736547|NCT00442689|Primary|Change in Fat Percentage as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan Over the Study Period|Change in fat percentage as measured by DEXA scan over the study period (Fat percentage at study endpoint - baseline fat percentage)|6 months|||percentage of body mass||Standard Deviation|Mean
736393|NCT00441766|Secondary|Percentage of Patients Who Experienced Adequate Relief of Irritable Bowel Syndrome (IBS) Pain (AR-IBS) at Week 4|"Percentage of patients who experienced AR-IBS at week 4. The AR-IBS is a self-evaluation by the patient of their perception of adequate relief of IBS pain over the last 7 days following treatment as compared to IBS pain before receiving treatment. Patients respond with either a Yes or No, where Yes indicated adequate relief of pain and No indicated no relief from pain."|Week 4|Modified Intent-To-Treat (m-ITT). The m-ITT population included all patients who started the study (randomized), who received the study medication and had at least one post-baseline mean highest-average-pain score.||Percentage of Patients|||Number
736394|NCT00441766|Secondary|Percentage of Patients Who Rated Their Condition as Improved on the Subject Global Impression of Change (SGIC) at Week 4|"Percentage of patients who rated their condition as improved on the SGIC at week 4. The SGIC score was assessed using a 7-point scale (score of 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). Patients self-evaluated their overall change in symptoms (relief from symptoms of abdominal discomfort, pain, and altered bowel habits). An improved condition was defined as a score of 1, 2, or 3."|Week 4|Modified Intent-To-Treat (m-ITT). The m-ITT population included all patients who started the study (randomized), who received the study medication and had at least one post-baseline mean highest-average-pain score.||Percentage of Patients|||Number
736395|NCT00441766|Primary|Change From Baseline in Mean Highest-Average-Pain Score at Week 4|Change from baseline in mean highest-average-pain score at Week 4. The mean highest-average-pain score was the average of the 7 highest daily-average-pain scores obtained over the 14 days prior to the Week 4 visit. Patients recorded their daily-average-pain on an 11-point scale (where 0 equals no pain and 10 equals worst pain imaginable). A negative number change from baseline represents a decrease in average pain (improvement).|Baseline, Week 4|Modified Intent-To-Treat (m-ITT). The m-ITT population included all patients who started the study (randomized), who received the study medication and had at least one post-baseline mean highest-average-pain score.||Scores on a Scale||Standard Deviation|Mean
736396|NCT00441792|Primary|Length of Stay|The primary outcome of the study was hospital length of stay.|time in days of hospitalization|All patients entering into the study were analyzed on an intent to treat basis.||days||Inter-Quartile Range|Median
736397|NCT00441792|Secondary|Mortality|In-hospital mortality.|Duration of hospitalization.|All patients entering into the study were analyzed on an intent to treat basis.||percentage of patients dying||95% Confidence Interval|Number
736398|NCT00441974|Secondary|Number of Participants With ADV-associated Resistance at Week 48|Week 48 serum samples from participants, who reached a HBV DNA breakthrough or have HBV DNA≥5 log copies/mL at Weeks 24 and 48 were assessed for the development of ADV (Adefovir dipivoxil) mutation (N236T and A181V) in the HBV polymerase. Virologic breakthrough was defined as an increase in the level of HBV DNA 1 log10 copy/mL from Week 24 to Week 48. ADV-associated resistance was defined as participants with both virologic breakthrough and ADV mutation.|Week 48|Intent-to-Treat (ITT) Population: all participants who actually received the study medication at least once.||participants|||Number
736399|NCT00441974|Secondary|Number of HBeAg Positive Participants Achieving HBeAg Loss and HBeAg Seroconversion at Week 48|HBeAg loss and HBeAg seroconversion (HBeAg loss and HBeAb detected) were assessed in participants who were HBeAg positive at Weeks 0 and 48. Confirmed HBeAg loss was defined as undetectable HBeAg.|Week 48|Intent-to-Treat (ITT) Population: all HBeAg positive participants who actually received the study medication at least once||participants|||Number
736400|NCT00441974|Secondary|Number of Participants Achieving ALT (Alanine Aminotransferase) Normalization at Week 48|Elevated serum ALT levels are defined as serum ALT levels greater than the upper limit of the normal range (ULN), as determined using local laboratory ranges. ALT normalization was defined as ALT measurements at or below the ULN after a baseline value above the ULN.|Week 48|Intent-to-Treat (ITT) Population: all participants who actually received the study medication at least once.||participants|||Number
736401|NCT00441974|Secondary|Change From Screening in Median Serum HBV DNA at Weeks 24 and 48|The HBV DNA level was tested in blood serum by real-time Polymerase Chain Reaction with the LLD (lower limit of detection) as 300 copies/milliliter (cp/mL) at screening, week 24, and week 48 in a central laboratory. The change in HBV DNA from screening to week 24 and week 48 was conducted.|Weeks 24 and 48|Intent-to-Treat (ITT) Population: all participants who actually received the study medication at least once.||log10 copies/milliliter||Full Range|Median
736402|NCT00441974|Secondary|Ranked Assessment of Liver Histology in HBeAg Positive Participants From Baseline to Week 48|A ranked assessment with the Knodell/HAI scoring system that represents the sum of scores for periportal bridging necrosis (0–10: none=0, moderate piecemeal necrosis plus bridging necrosis=5, multilobular necrosis=10); interlobular degeneration and focal necrosis (0–4: none=0, marked=4); portal inflammation (0–4: none=0, marked=4) and fibrosis (0–4: none=0, fibrous portal expansion=1, bridging fibrosis=3, cirrhosis=4) was carried out by two pathologists in the HBeAg positive participants who underwent liver biopsy at baseline and Week 48/withdrawal.|Baseline to Week 48|HBeAg positive chronic hepatitis B participants who underwent liver biopsy at Week 48||points on a scale||Standard Deviation|Mean
736403|NCT00441974|Secondary|Number of HBeAg Positive Participants Achieving Histological Improvement at Week 48|Histological improvement (defined as a ≥2 point reduction in the Knodell necroinflammation score without worsening fibrosis) was accessed by two pathologists in HBeAg-positive participants undergoing liver biopsy at baseline and week 48/withdrawal. Knodell/Histological Activity Index (HAI) score = combined scores for necrosis, inflammation, and fibrosis and is the sum of scores for periportal bridging necrosis (0–10: none=0, multilobular necrosis=10), intralobular degeneration and focal necrosis and portal inflammation (0–4: none=0, marked=4), and fibrosis (0–4: none=0, cirrhosis=4).|Week 48|HBeAg positive chronic hepatitis B participants who underwent liver biopsy at Week 48||participants|||Number
736404|NCT00441974|Primary|Number of Participants Achieving HBV DNA (Hepatitis B Virus Deoxyribonucleic Acid) <1000 Copies/Milliliter at Week 48|HBV (Hepatitis B Virus) DNA level was tested by real-time Polymerase Chain Reaction at Week 48.|Week 48|Intent-to-Treat (ITT) Population: all participants who actually received the study medication at least once.||participants|||Number
736405|NCT00442013|Secondary|Airways Reactivity (Assessed by Methacholine PC20)|Presence and degree of airway hyperresponsiveness; change from baseline to 24 weeks for airways reactivity assessed by methacholine post-diluent baseline (PC20) after medication holds|Measured at Weeks 0 and 24|||mg/mL||95% Confidence Interval|Mean
736407|NCT00442013|Secondary|Rate of Episodes of Poor Asthma Control (EPAC)|"Episodes of poor asthma control are defined as any one of the following:
2 consecutive days with peak flow at less than 70% of baseline
prescription of oral corticosteroids for asthma
seeking urgent medical care for asthma symptoms
EPAC was measured by review of daily diaries that were maintained over the entire course of followup, i.e, 24 weeks"|Measured daily for 24 weeks by diary|The number of episodes of poor asthma control that occurred in each group over the 24-week follow-up period. Some participants experienced more than one EPAC over the course of follow-up||number of episodes of poor asthma contrl|||Number
736408|NCT00442013|Secondary|Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)|A measure of pulmonary function, specifically the amount of expired air in the first second during a forced expiratory maneuver while seated; test performed at least 4 hours after last dose of short-acting bronchodilator and at least 12 hours after long-acting bronchodilator; number presents an average of the change from baseline to all follow-up points|Measured at Weeks 0, 4, 8, 12, 16, 20, 24|||Liters||95% Confidence Interval|Mean
736409|NCT00442013|Secondary|Asthma-specific Quality of Life|Scores range from 1 to 7 with higher values indicating better asthma-related quality of life; questionnaire measures functional impairments that are most troublesome to children as a result of their asthma; number presents an average of the change from baseline to all follow-up points|Measured at Weeks 0, 4, 8, 12, 16, 20, 24|||score||95% Confidence Interval|Mean
736410|NCT00442013|Primary|Change in Juniper Asthma Control Score (ACS)|Score ranges from 0 to 6, a lower score indicated better asthma control. Scores above 1.5 are indicative of poor asthma control; score obtained from questionnaire with 6 questions related to asthma control and FEV (amount of air expired in the first second during a forced expiratory maneuver); number presents an average of the change from baseline to all follow-up points|Measured at Weeks 0, 4, 8, 12, 24|||score||95% Confidence Interval|Mean
736411|NCT00442117|Secondary|Mean Percent Change of AM PEFR (Peak Exploratory Flow Rate) From Baseline to Week 12.|The AM PEFR measurement at the Baseline visit was compared to the AM PEFR measurement during the last visit at Week 12. The mean percent change was calculated.|Baseline and Week 12|Intent-to treat (ITT) population: All randomized patients who have taken at least one dose of study medication and have at least one post-baseline efficacy information. Two participants in the MF-DPI group and three participants in the BUD-DPI group were excluded from the analysis.||Percent Change of AM PEFR||Standard Deviation|Mean
736412|NCT00442117|Secondary|Mean Percent Change of Forced Expiratory Flow (FEF) at (25-75% Interval) From Baseline to Week 12.|The FEF (25-75%) measurement at the baseline was compared to the FEF (25-75%) measurement during the last visit at Week 12. The mean percent change was calculated.|Baseline and Week 12|Intent-to treat (ITT) population: All randomized patients who have taken at least one dose of study medication and have at least one post-baseline efficacy information.||Percent Change of FEF||Standard Deviation|Mean
736413|NCT00442117|Secondary|Mean Percent Change of FVC (Forced Vital Capacity) From Baseline to Week 12.|The FVC measurement at the baseline was compared to the FVC measurement during the last visit at Week 12. The mean percent change was calculated.|Baseline and Week 12|Intent-to treat (ITT) population: All randomized patients who have taken at least one dose of study medication and have at least one post-baseline efficacy information.||Percent Change of FVC||Standard Deviation|Mean
736414|NCT00442117|Primary|Mean Percent Change of Forced Expiratory Volume in One Second (FEV1) From Baseline to Week 12.|FEV1 (forced expiratory volume in one second) measurement at the Baseline visit was compared to the FEV1 measurement during the last visit at Week 12. The mean percent change was calculated.|Baseline and Week 12|Intent-to treat (ITT) population: All randomized patients who have taken at least one dose of study medication and have at least one post-baseline efficacy information.||Percent Change of FEV1||Standard Deviation|Mean
736415|NCT00442169|Primary|Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination.||Days 0 to 28 post-vaccination|Safety analysis was on all enrolled and vaccinated participants according to the vaccine actually received, safety population.||Participants|||Number
736416|NCT00442169|Primary|Number of Viremic Participants Post-vaccination|Viremic = detectable level of ≥ 10 plaque-forming units (PFU)/mL|Day 21 post-vaccination|Viremia was assessed in all participants in the safety population according to the vaccine actually received.||Participants|||Number
736417|NCT00442169|Other Pre-specified|Number of Participants With Positive Immunoglobulin M (IgM) Response Post-vaccination in the As Treat Per-Protocol Population||Days 14 and 28 post-vaccination|Immunoglobulin M (IgM) response was assessed in all participants in the safety population according to the vaccine actually received, As Treat Per-Protocol Population||Participants|||Number
736418|NCT00442169|Secondary|Geometric Mean Titers of Neutralizing Antibody Titers Pre- and Post-vaccination.||Days 0, 14, and 28 post-vaccination|Geometric mean titers were assessed according to the vaccine actually received, in the As treat per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
736419|NCT00442169|Primary|Number of Participants With Fourfold or Greater Post-vaccination Titers (Seroconversion).|Seroconversion was defined as a fourfold or greater rise in titer between pre- and post-immunization samples|Day 28 post-vaccination|Seroconversion was assessed in all participants in the safety population according to the vaccine actually received, As Treat Per-Protocol Population||Participants|||Number
736420|NCT00442286|Primary|Therapy-related Adverse Event-free Rate.|Compare Group A (Rheos® Device On ) versus Group B (Rheos® Device Off) therapy-related adverse event-free rates via a double-blind, randomized, parallel group, non-inferiority design for therapy-related serious adverse events occurring between 30 days post-implant and the Month 6 visit. The non-inferiority margin was 15%.|6 months post-activation|||percentage of participants||95% Confidence Interval|Number
736421|NCT00442286|Primary|Major Hypertension-related and Serious Device-related Adverse Event-Free Rate in Both Implanted and Attempted Patients.|"Compare the event-free rate for all major hypertension-related and serious device-related adverse events occurring between 30 days post-implant and the Month 12 visit, to a pre-specified objective performance criterion of 72% based on similar implantable devices such as defibrillators and resynchronization devices.
Note: The purpose of this outcome measure was to evaluate the effect of having the device implanted, not to compare the outcomes between the two treatment groups. Therefore, both groups were analyzed as a single cohort."|12 months-post activation|||percentage of participants||95% Confidence Interval|Number
736422|NCT00442286|Primary|Serious Procedure- or System-related Adverse Event-free Rate in Both Implanted and Attempted Patients|"Compare the serious procedure- or system-related adverse event-free rate for events occurring within 30 days of implant to a pre-specified objective performance criterion of 82% set based on historical literature on implantable cardioverter defibrillators (ICD) and pacemakers.
Note: The purpose of this outcome measure was to evaluate the effect of having the device implanted, not to compare the outcomes between the two treatment groups. Therefore, both groups were analyzed as a single cohort."|30 days post implant|||percentage of participants||95% Confidence Interval|Number
736423|NCT00442286|Primary|Percent of Group A (Rheos® Device On) Patients Who Maintain a 10 mm Hg Drop in Systolic Blood Pressure at 12 Months Post-activation, and Whose Response at 12 Months is at Least 50% of the Response Observed at 6 Months Post-activation.|Compare the sustained response in SBP Month 12 in Group A ( Rheos® Device On ) responders at Month 6 to an objective performance criterion of 65%. A sustained response to therapy required the reduction from Month 0 to Month 12 to be at least 10 mmHg and to remain at least 50% of that seen at Month 6.|12 months post-activation|||percentage of participants||97.5% Confidence Interval|Number
736424|NCT00442286|Primary|Percent of Patients With a 10mmHg or Greater Reduction in Office Cuff Systolic Blood Pressure|Compare Group A (Rheos® Device On ) versus Group B (Rheos® Device Off) via a double-blind, randomized, parallel group, super-superiority design for proportion of subjects that achieve at least a 10 mm Hg drop in systolic blood pressure at Month 6 compared to Month 0, with a superiority margin of 20%.|6 months post-activation|||percentage of participants||95% Confidence Interval|Number
736425|NCT00442338|Primary|Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Within the First 60 Minutes After Administration|The time weighted average change from Baseline in Forced Expiratory Volume in One Second (FEV1) over the first 60 minutes after study drug administration (average change FEV1 (0-60 min)). Baseline (pre-allocation) was the last measurement obtained during the screening period.|Baseline and 60 minutes after study drug administration|Per Protocol Set (PPS): subset of participants who comply with the protocol sufficiently to ensure that these data will likely exhibit effects of treatment, according to the underlying scientific model. Aminophylline 250 mg - 1 participant with no FEV1 data at 60 minutes was excluded from the analysis.||Liter||95% Confidence Interval|Least Squares Mean
736426|NCT00442351|Primary|Change From Baseline to Final/Terminal Visit in Forced Expiratory Value in 1 Second (FEV1) in Morning Office Measurements.|The baseline value for this outcome measure was evaluated at the baseline visit prior to randomization. The change from Baseline to final/terminal visit in FEV1 was to be analyzed using an Analysis of Covariance (ANCOVA) model.|Twelve (12) weeks||||||
736427|NCT00442364|Primary|Patients With Circulating MCA Bubbles Present on MRI Who Had Signficant Clinical or Neurological Effects||28 day followup|||participants|||Number
736428|NCT00442416|Secondary|Number of Participants With Any AEs, Any Serious Adverse Events and Death|An AE is untoward medical occurrence in a participant who received the study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is with any of the following outcomes: Death, initial or prolonged inpatient hospitalisation, life-threatening experience, persistent or significant disability/incapacity; congenital anomaly.|Up to 9 months|Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.||Participants|||Number
736429|NCT00442416|Secondary|Number of Participants With Anti-RO0503821 Antibody in Human Serum|RO0503821 is a chemically modified erythropoietin which helps to make more RBCs and is used for the treatment of anemia of chronic kidney disease. However, during treatment with RO0503821, anti-RO0503821 antibody may develop in human serum. These antibodies have been shown to cross-react with all ESAs and leads to failure to respond. Number of participants with anti- RO0503821 antibody that are quantifiable and those that were “BLQ” at Baseline (Day 0) and Visit 17 (M 9) or final visit/early termination in human serum samples are reported.|Up to Month 9|Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.||Participants|||Number
736430|NCT00442416|Secondary|Number of Participants With Anti-erythropoietin Antibody in Human Serum|Erythropoietin is human protein which helps to make more RBCs and is used for the treatment of anemia of chronic kidney disease. However, during treatment with erythropoietin, anti-erythropoietin antibody (Anti-EPO) may develop in human serum. These antibodies have been shown to cross-react with all ESAs and leads to failure to respond to treatment. Number of participants with anti-EPO antibody that are quantifiable and those that were “below the limit of quantification (BLQ)” at Baseline (Day 0) and Visit 17 (Month 9 [M 9]) or final visit/early termination in human serum samples are reported.|Up to Month 9|Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.||Participants|||Number
736431|NCT00442416|Secondary|Mean Change From Baseline in Weight||From Baseline (D 0) to D1 and D15 of M7, M8|Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment. Participants with available data at the time of evaluation were denoted as 'n'.||kilogram||Standard Deviation|Mean
736432|NCT00442416|Secondary|Mean Change From Baseline in Pulse Rate||From Baseline (D 0) to D1 and D15 of M7, M8|Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment. Participants with available data at the time of evaluation were denoted as 'n'.||Beats per minute||Standard Deviation|Mean
736433|NCT00442416|Secondary|Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure||From Baseline (D 0) to D1 and D15 of M7, M8|Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment. Participants with available data at the time of evaluation were denoted as 'n'.||millimeter of mercury||Standard Deviation|Mean
736434|NCT00442416|Secondary|Mean Change From Baseline in Temperature||From Baseline (D 0) to D1 and D15 of M7, M8|Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment. Participants with available data at the time of evaluation were denoted as 'n'.||Degree Celsius||Standard Deviation|Mean
736548|NCT00442689|Primary|Change in Visceral Adipose Tissue (VAT) Volume as Measured by MRI|Change in visceral adipose tissue (VAT) volume as measured by MRI (VAT at study endpoint - baseline VAT)|6 months|||L||Standard Deviation|Mean
736435|NCT00442416|Secondary|Mean Change From Baseline in Total Iron-binding Capacity|Adequate iron status is prerequisite to achieve and maintain target Hb levels. Mean change from Baseline (D 0) in total Iron-binding Capacity to D1 of M2, 3, 4, 5, 6, 7, and 8 is reported.|From Baseline (D 0) to M2, M3, M4, M5, M6, M7, M8|Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment. Participants with available data at the time of evaluation were denoted as 'n'.||mg per dL||Standard Deviation|Mean
736436|NCT00442416|Secondary|Mean Change From Baseline in Serum Transferrin|Adequate iron status is prerequisite to achieve and maintain target Hb levels. Mean change from Baseline (D 0) in serum transferrin to D1 of M2, 3, 4, 5, 6, 7, and 8 is reported.|From Baseline (D 0) to M2, M3, M4, M5, M6, M7, M8|Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment. Participants with available data at the time of evaluation were denoted as 'n'.||milligram (mg) per dL||Standard Deviation|Mean
736437|NCT00442416|Secondary|Mean Change From Baseline in Transferrin Saturation|Adequate iron status is prerequisite to achieve and maintain target Hb levels. Mean change from Baseline (D 0) in transferrin to D1 of M2, 3, 4, 5, 6, 7, and 8 is reported.|From Baseline (D 0) to M2, M3, M4, M5, M6, M7, M8|Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment. Participants with available data at the time of evaluation were denoted as 'n'.||Percentage of Transferrin Saturation||Standard Deviation|Mean
736438|NCT00442416|Secondary|Mean Change From Baseline in Ferritin|Adequate iron status is prerequisite to achieve and maintain target Hb levels. Mean change from Baseline (D 0) in ferritin to D1 of M2, 3, 4, 5, 6, 7, and 8 is reported.|From Baseline (D 0) to M2, M3, M4, M5, M6, M7, M8|Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment. Participants with available data at the time of evaluation were denoted as 'n'.||microgram per litre||Standard Deviation|Mean
736439|NCT00442416|Secondary|Mean Change From Baseline in Iron|Adequate iron status is prerequisite to achieve and maintain target Hb levels. Mean change from Baseline (D 0) in iron to D1 of Months 2, 3, 4, 5, 6, 7, 8 is reported.|From Baseline (D 0) to Month (M) 2, M3, M4, M5, M6, M7, M8|Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment. Participants with available data at the time of evaluation were denoted as 'n'.||micromole per litre||Standard Deviation|Mean
736440|NCT00442416|Secondary|Number of Participants With Marked Laboratory Abnormalities|Participants with marked laboratory abnormalities in hematology and clinical chemistry parameters are reported. Hematology laboratory parameters included hematocrit fraction, hemoglobin, platelets, white blood cells (WBCs) and clinical chemistry parameters included aspartate aminotransferase ([AST], alanine aminotransferase ([ALT], creatine phosphokinase (CPK), alkaline phosphatase, albumin, potassium, fasting glucose and phosphate.|Up to Month 9|Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment. Participants with available data at the time of evaluation were denoted as ‘n’.||Participants|||Number
736441|NCT00442416|Secondary|Percentage of Participants With Safety-Related Hb Measures|Safety-related Hb measures included percentage of participants with Hb value > 13 g/dL, 13.5 g/dL, increase in Hb value from baseline by > 2 g/dL or decrease in Hb value from baseline by > 2 g/dL at any time during the study.|Up to Month 9|Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.||Percentage of participants|||Number
736442|NCT00442416|Primary|Mean Change From Baseline in Hb Concentration to Average Over the Evaluation Period|Mean change in Hb concentration from Baseline (Day [D] 0) to average during the evaluation period (Month 7 to 9) is reported.|From Baseline (D 0) to 9 months|Per-protocol population included all randomized participants who received at least one dose of the study drug and met all study entry criteria with no major protocol violations. Participants with available data at the time of evaluation were analyzed.||g/dL||Standard Deviation|Mean
736443|NCT00442468|Secondary|"Number of Participants Who Responded Yes When Asked Indicated Questions Regarding Medical History"|IBD, inflammatory bowel disease; GERD, gastroesophageal reflux disease.|Day 1 of 1-day study|All participant respondents to the questions||participants|||Number
736444|NCT00442468|Secondary|Number of Participants With the Indicated Experience With Tobacco Smoking||Day 1 of 1-day study|All participant respondents to the questions||participants|||Number
736445|NCT00442468|Secondary|Number of Participants Who Completed the Highest Indicated Education Level or Grade||Day 1 of 1-day study|All participant respondents to the questions||participants|||Number
736446|NCT00442468|Secondary|"Number of Participants Who Responded Yes to Respective Questions Regarding Occupational History and Socioeconomic Status"||Day 1 of a 1-day study|All participant respondents to the questions||participants|||Number
736447|NCT00442468|Secondary|"Number of Participants Who Responded Yes to Respective Questions Regarding Past Illness"||Day 1 of a 1-day study|All participant respondents to the questions||participants|||Number
736448|NCT00442468|Secondary|Post-bronchodilator Reversibility Measures|To assess the reversibility in COPD, a bronchodilator was administered before performing another round of tests for comparison. This is commonly referred to as a reversibility test for the likelihood for a participant to revert to their baseline spirometric values or a post-bronchodilator test (Post BD) and is an important part in diagnosing asthma versus COPD, particularly since reversibility is not observed in the latter case. This differentiates COPD from other diseases.|Day 1 of a 1-day study|All participants who completed pre- and post-bronchodilator spirometry||participants|||Number
736449|NCT00442468|Secondary|FEV1 Percent Predicted and FEV1/FVC Percent Predicted, Post-bronchodilator Spirometry Measures|"Participants completed the pulmonary function test 15-30 minutes after bronchodilator administration. The FEV1 percent predicted and FEV1/FVC percent predicted are the test results as a percentage of the predicted values for participants of similar characteristics (height, age, sex, and sometimes race and weight)."|Day 1 of a 1-day study|All participants who completed pre- and post-bronchodilator spirometry||percentage||Standard Deviation|Mean
736450|NCT00442468|Secondary|FEV1 and FVC, Post-bronchodilator Spirometry Measures|Participants completed the pulmonary function test 15-30 minutes after bronchodilator administration. FEV1 is the volume of air expelled from the lungs in 1 second, and FVC is the volume of air that can forcibly be blown out after full inspiration).|Day 1 of a 1-day visit|All participants who completed post-bronchodilator spirometry||Liters||Standard Deviation|Mean
736451|NCT00442468|Secondary|FEV1 Percent Predicted and FEV1/FVC Percent Predicted, Pre-bronchodilator Spirometry Measures|"Participants self-administered a bronchodilator (albuterol) in the presence of trained site staff 15 to 30 minutes prior to pulmonary function test. The FEV1 percent predicted and FEV1/FVC percent predicted are the test results as a percentage of the predicted values for participants of similar characteristics (height, age, sex, and sometimes race and weight)."|Day 1 of a 1-day study|All participants who completed pre-bronchodilator spirometry||percentage||Standard Deviation|Mean
736452|NCT00442468|Secondary|FEV1 and FVC, Pre-bronchodilator Spirometry Measures|Participants self-administered a bronchodilator (albuterol) in the presence of trained site staff 15 to 30 minutes prior to pulmonary function test. FEV1 is the volume of air expelled from the lungs in 1 second, and FVC is the volume of air that can forcibly be blown out after full inspiration).|Day 1 of a 1-day study|All participants who completed pre-bronchodilator spirometry||Liters (L)||Standard Deviation|Mean
736453|NCT00442468|Secondary|Number of Participants With the Indicated Responses to the Question of How Often They Experience Interference With Social Activities, a Question on the 12-item Short Form Health Survey|The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.|Day 1 of a 1-day study|All participant respondents to the question||participants|||Number
736454|NCT00442468|Secondary|Number of Participants With the Indicated Responses to the Question of How Often They Felt Downhearted and Depressed, a Question on the 12-item Short Form Health Survey|The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.|Day 1 of a 1-day study|All participant respondents to the question||participants|||Number
736455|NCT00442468|Secondary|Number of Participants With the Indicated Responses to the Question of How Often They Have a Lot of Energy, a Question on the 12-item Short Form Health Survey|The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.|Day 1 of a 1-day study|All participant respondents to the question||participants|||Number
736456|NCT00442468|Secondary|Number of Participants With the Indicated Responses to the Question of How Often They Felt Calm and Peaceful, a Question on the 12-item Short Form Health Survey|The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.|Day 1 of a 1-day study|All participant respondents to the question||participants|||Number
736457|NCT00442468|Secondary|Number of Participants With the Indicated Responses to the Question of to What Degree Does Pain Interfere With Normal Work, a Question on the 12-item Short Form Health Survey|The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.|Day 1 of a 1-day study|All participant respondents to the question||participants|||Number
736458|NCT00442468|Secondary|Number of Participants With the Indicated Responses to the Question of How Often They Did Work Less Carefully Due to Emotional Problems, a Question on the 12-item Short Form Health Survey|The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.|Day 1 of a 1-day study|All participant respondents to the question||participants|||Number
736459|NCT00442468|Secondary|Number of Participants With the Indicated Responses to the Question of How Often They Accomplished Less Due to Emotional Problems, a Question on the 12-item Short Form Health Survey|The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.|Day 1 of a 1-day study|All participant respondents to the question||participants|||Number
736486|NCT00442546|Secondary|Pain-Related Sleep Interference Post Surgery|The NRS-Sleep: subject rated 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]) rating how pain has interfered with sleep during the past 24 hours. Weekly mean scores were calculated post hospital discharge.|24 hours, 48 hours, 72 hours, 96 hours 120 hours, 144 hours, 168 hours, and 192 hours post-surgery, Week 2, Week 4, Week 6/ET|MITT. There were not enough subjects with data at 144, 168, and 192 hours to calculate least squares mean values.||scores on a scale||Standard Error|Least Squares Mean
736460|NCT00442468|Secondary|Number of Participants With the Indicated Responses to the Question of How Often They Were Limited in the Kind of Work/Activities, a Question on the 12-item Short Form Health Survey|The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.|Day 1 of a 1-day study|All participant respondents to the question||participants|||Number
736461|NCT00442468|Secondary|Number of Participants With the Indicated Responses to the Question of Whether They Had Accomplished Less Than They Would Like, a Question on the 12-item Short Form Health Survey|The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.|Day 1 of a 1-day study|All participant respondents to the question||participants|||Number
736462|NCT00442468|Secondary|Number of Participants With the Indicated Responses to the Question of Whether Their Health is Limited in Climbing Stairs, a Question on the 12-item Short Form Health Survey|The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.|Day 1 of a 1-day study|All participant respondents to the question||participants|||Number
736463|NCT00442468|Secondary|Number of Participants With the Indicated Responses to the Question of Whether Their Health is Limited in Moderate Activities, a Question on the 12-item Short Form Health Survey|The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.|Day 1 of a 1-day study|All participant respondents to the question||participants|||Number
736464|NCT00442468|Secondary|Number of Participants With the Indicated Responses to the Question of How They'd Rate Their General Health, a Question on the 12-item Short Form Health Survey|The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.|Day 1 of a 1-day study|All participant respondents to the question||participants|||Number
736465|NCT00442468|Secondary|Number of Participants With an Affirmative Response to Specific Categories on the Modified American Thoracic Society (ATS) Respiratory Questionnaire|The Modified ATS Respiratory Questionnaire is a participant-completed questionnaire used to assess pulmonary disease symptomatology (such as cough, phlegm).|Day 1 of 1-day study|All study participants who completed the questionnaire||participants|||Number
736466|NCT00442468|Secondary|Number of Participants With the Indicated Scores on the MRC (Medical Research Council) Dyspnea Scale|The MRC scale is a 6-point scale (scores from 0 to 5; encompassing degrees of dyspnea of none, slight, moderate, moderately severe, severe, and very severe) used to assess (via a participant-completed questionnaire) the amount of routine daily physical activity that precipitates dyspnea. The levels of physical activity range from strenuous exercise, to walking (including up a slight hill, on level ground, and to 100 yards), and to dressing and undressing.|Day 1 of a 1-day study|All enrolled participants who completed the questionnaire||participants|||Number
736467|NCT00442468|Primary|Number of Participants With a Post-bronchodilator FEV1/FVC <=70% Versus Participants With a Postbronchodilator FEV1/FVC >70%|Ratio of Forced Expiratory Volume in 1 second (volume of air expelled from the lungs in 1 second) by the Forced Vital Capacity (FVC, the volume of air that can forcibly be blown out after full inspiration) is a spirometric measure (lung function test) used to demonstrate airway obstruction. FEV1/FVC <=0.7 is used to demonstrate airway obstruction characteristic of chronic obstructive pulmonary disease (COPD).|Day 1 of a 1-day Study; before and 15-30 min after albuterol (self-administered under supervision of trained site staff)|All enrolled participants who completed pre- and post-bronchodilator spirometry||participants|||Number
736468|NCT00442507|Secondary|Incidence and Severity of Toxicities|Grade 3 and higher toxicities using CTCAE Version 3.0.|Median follow-up time for toxicities 72 days (72 days-156 days)|Details of all SAEs and AEs are listed in the Serious Adverse Events and Other Adverse Events modules.||participants|||Number
736469|NCT00442507|Secondary|Response Rate (Complete Response (CR), Partial Response (PR), and CR+PR)|"CR = disappearance of all target lesions
PR = at least a 30% decrease in the sum of the LD of the target lesions taking as reference the baseline sum LD."|Median follow-up for response 6 weeks (6-18 weeks)|1 participant was not analyzed because the participant was removed from study during the first cycle due to an adverse event and was considered not evaluable for this outcome.||participants|||Number
736470|NCT00442507|Secondary|Overall Survival Rate (OS)|OS is defined as the time from initiation of treatment to the date of death for any reason.|Median followup time from completion of treatment 325.5 days (44-401 days)|||months||95% Confidence Interval|Median
736545|NCT00442689|Primary|Change in Resting Energy Expenditure (REE) Over the Study Period|Change in resting energy expenditure (REE) over the study period (REE at study endpoint - baseline REE)|6 months|||Kcal/day||Standard Deviation|Mean
736471|NCT00442507|Primary|Time to Progression (TTP)|"TTP is defined as the time from initiation of treatment to the date of documented progression.
The median of TTP with 95% confidence interval will be presented.
Progressive disease (target lesions) is defined as at least a 20% increase in the sum of the longest diameter of the target lesions taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.
Progressive disease (non-target lesions) is defined as appearance of one or more new lesions. Unequivocal progression of existing non-target lesions."|Median follow-up for TTP 6 weeks (6-18 weeks)|1 participant was not analyzed because the participant was removed from study during the first cycle due to an adverse event and was considered not evaluable for this outcome.||months||95% Confidence Interval|Median
736472|NCT00442546|Secondary|Neuropathic Pain Symptom Inventory (NPSI)|NPSI: subject rated questionnaire to evaluate 5 dimensions of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia). Includes 10 descriptors ranging from 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each relevant dimension. Total score is calculated as the sum of scores of the 10 descriptors, range: 0-100. Higher score indicates greater intensity of pain.|Month 3, Month 6 (phone call)|MITT||scores on a scale||Standard Deviation|Mean
736473|NCT00442546|Secondary|Number of Subjects With Persistent Pain Based on 11-Point Verbal Rating Scale (VRS)|"The presence of persistent pain was evaluated on the 11-point VRS. The subject answered the question: how much pain did you experience in the last 24 hours in your operated knee? A zero score of VRS was the only number considered as a no. Any positive score (1-10) of VRS was consider as yes."|Month 3, Month 6 (phone call)|MITT||participants|||Number
736474|NCT00442546|Secondary|Number of Subjects With Global Evaluation of Study Medication Scores|The Global Evaluation of Study Medication is a subject-administered single item instrument that records the subject’s overall impression (global evaluation) of the study medication by asking the following question: how would you rate the study medication you received for pain? The subject chooses based on a scale of 1 (poor), 2 (fair), 3 (good), or 4 (excellent).|Discharge, Week 2, Week 4, and Week 6/ET|MITT||participants|||Number
736475|NCT00442546|Secondary|Overall Pain Relief Measured by the PTSS|Measure of subject satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment.|Discharge, Week 2, Week 4, and Week 6/ET|MITT||scores on a scale||Standard Error|Least Squares Mean
736476|NCT00442546|Secondary|Overall Satisfaction Measured by the PTSS|Measure of subject satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment.|Discharge, Week 2, Week 4, and Week 6/ET|MITT.||scores on a scale||Standard Error|Least Squares Mean
736477|NCT00442546|Secondary|Satisfaction With Medication Efficacy Measured by the PTSS|Measure of subject satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment.|Discharge, Week 2, Week 4, Week 6/ET|MITT.||scores on a scale||Standard Error|Least Squares Mean
736478|NCT00442546|Secondary|Satisfaction With Medication Characteristics Measured by the PTSS|Measure of subject satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment.|Discharge, Week 2, Week 4, Week 6/ET|MITT.||scores on a scale||Standard Error|Least Squares Mean
736479|NCT00442546|Secondary|Satisfaction With Current Pain Medication Measured by the Pain Treatment Satisfaction Scale (PTSS)|Measure of subject satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment.|Discharge, Week 2, Week 4, Week 6/ET|MITT.||scores on a scale||Standard Error|Least Squares Mean
736480|NCT00442546|Secondary|Time From End of Surgery to Actual Discharge|The analysis was performed by Kaplan-Meier method with log-rank test.|time from end of surgery up to 192 hours post surgery|MITT||hours||Standard Error|Mean
736481|NCT00442546|Secondary|Time From End of Surgery to Meet Hospital Discharge Criteria|The analysis was performed by Kaplan-Meier method with log-rank test.|time from end of surgery up to 192 hours post surgery|MITT||hours||Standard Error|Mean
736482|NCT00442546|Secondary|ROM Assessment of the Passive Flexion of the Surgical Knee|The degree of passive (movement of the knee with the aid of physical therapist or designee) knee flexion and extension tolerated by each subject was recorded. Passive ROM in the sitting position was assessed with a goniometer.|24 hours, 48 hours, 72 hours, 96 hours, and 120 hours post surgery, Week 2, Week 4, Week 6/ET|MITT. There were not enough subjects with data at 144, 168, and 192 hours to calculate least squares mean values.||degrees||Standard Error|Least Squares Mean
736483|NCT00442546|Secondary|Range of Motion (ROM) Assessment of the Active Flexion of the Surgical Knee|The degree of active (patient moving the knee) knee flexion and extension tolerated by each subject was recorded. Active ROM in the sitting position was assessed with a goniometer.|24 hours, 48 hours, 72 hours, 96 hours, and 120 hours post surgery, Week 2, Week 4, Week 6/ET|MITT. There were not enough subjects with data at 144, 168, and 192 hours to calculate least squares mean values.||degrees||Standard Error|Least Squares Mean
736484|NCT00442546|Secondary|Timed Up-and-Go (TUG)|TUG: time taken in seconds to rise from a standard arm chair, walk to a line on the floor 3 meters away, turn, return and sit down again.|24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Week 2, Week 4, Week 6/ET|MITT. There were not enough subjects with data at 120 (Pregabalin 300 mg only), 144, 168, and 192 hours to calculate least squares mean values.||seconds||Standard Error|Least Squares Mean
736485|NCT00442546|Secondary|Change From Baseline in Visual Analogue Scale for Anxiety (VAS-Anxiety) Score Prior to Surgery|VAS-Anxiety was administered to measure pre-operative anxiety. Score: 0 = no anxiety to 100 = worst imaginable anxiety.|Day 1, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours prior to surgery|MITT. There were not enough subjects with data at 6 hours to calculate least squares mean values.||scores on a scale||Standard Error|Least Squares Mean
736487|NCT00442546|Secondary|Current Pain During the Hospital Stay Assessed by the Pain NRS|"Subject rated scale for average pain intensity over the last 24 hours. Pain was assessed using the question How much pain do you have right now? Scores range from 0 (no pain) to 10 (most possible pain)."|4, 8, 12, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, 104, 112, 120, 128, 136, 144, 152, 160, 168, 176, 184, and 192 hours during the hospital stay|MITT. There were not enough subjects with data at 112, 120, 128, 136, 144, 152, 160, 168, 176, 184, and 192 hours to calculate least squares mean values.||scores on a scale||Standard Error|Least Squares Mean
736488|NCT00442546|Secondary|Daily and Weekly Average Pain During the Hospital Stay and Post Discharge Assessed by the Pain NRS|Subject rated scale for average pain intensity over the last 24 hours. Scores range from 0 (no pain) to 10 (pain as bad as you can imagine). Weekly mean scores were calculated post-discharge.|12 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours, 168 hours, and 192 hours during the hospital stay, Week 2, Week 4, Week 6/ET|MITT. There were not enough subjects with data at 144, 168, and 192 hours to calculate least squares mean values.||scores on a scale||Standard Error|Least Squares Mean
736489|NCT00442546|Secondary|Daily and Weekly Worst Pain During the Hospital Stay and Post Discharge Assessed by the Pain Numerical Rating Scale (NRS)|Subject rated scale for worst pain over the last 24 hours. Scores ranged from 0 (no pain) to 10 (pain as bad as you can imagine). Weekly mean scores were calculated post-discharge.|12 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours, 168 hours, and 192 hours during the hospital stay, Week 2, Week 4, Week 6/ET|MITT. There were not enough subjects with data at 144, 168, and 192 hours to calculate least squares mean values.||scores on a scale||Standard Error|Least Squares Mean
736490|NCT00442546|Secondary|Pain Interference With Sleep as Measured by the m-BPI-sf|m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Q5F: Subject response to ‘how, during the past 24 hours, pain has interfered with your sleep’. Scale: 0 = does not interfere to 10 = completely interferes.|Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6|MITT||scores on a scale||Standard Error|Least Squares Mean
736491|NCT00442546|Secondary|Pain Interference With Normal Work as Measured by the m-BPI-sf|m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Q5D: Subject response to ‘how, during the past 24 hours, pain has interfered with your normal work (work outside the home and housework)’. Scale: 0 = does not interfere to 10 = completely interferes.|Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6|MITT||scores on a scale||Standard Error|Least Squares Mean
736492|NCT00442546|Secondary|Pain Interference With Walking Ability as Measured by the m-BPI-sf|m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Q5C: Subject response to ‘how, during the past 24 hours, pain has interfered with your walking ability’. Scale: 0 = does not interfere to 10 = completely interferes.|Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6|MITT||scores on a scale||Standard Error|Least Squares Mean
736493|NCT00442546|Secondary|Pain Interference With Mood as Measured by the m-BPI-sf|m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Q5B: Subject response to ‘how, during the past 24 hours, pain has interfered with your mood’. Scale: 0 = does not interfere to 10 = completely interferes.|Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6|MITT||scores on a scale||Standard Error|Least Squares Mean
736494|NCT00442546|Secondary|Pain Interference With General Activity as Measured by the m-BPI-sf|m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Q5A: Subject response to ‘how, during the past 24 hours, pain has interfered with your general activity. Scale: 0 = does not interfere to 10 = completely interferes.|Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6|MITT||scores on a scale||Standard Error|Least Squares Mean
736495|NCT00442546|Secondary|Pain Interference With Enjoyment of Life as Measured by the m-BPI-sf|m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Q5G: Subject response to ‘how, during the past 24 hours, pain has interfered with your enjoyment of life’. Scale: 0 = does not interfere to 10 = completely interferes.|Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6|MITT||scores on a scale||Standard Error|Least Squares Mean
736496|NCT00442546|Secondary|Pain Interference With Relations With People as Measured by the m-BPI-sf|m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Q5E: Subject response to ‘how, during the past 24 hours, pain has interfered with your relations with other people’. Scale: 0 = does not interfere to 10 = completely interferes.|Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6|MITT||scores on a scale||Standard Error|Least Squares Mean
736497|NCT00442546|Secondary|Pain Interference Index Score as Measured by the m-BPI-sf|m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Pain interference index = average of pain interference question (Q) 5A to 5G. Questions were asked as follows: how, during the past 24 hours, has pain interfered with general activity (Q5A), mood (Q5B), walking ability (Q5C), normal work (outside home and housework) (Q5D), relations with other people (Q5E), sleep (Q5F), enjoyment of life (Q5G). Scale: 0=does not interfere to 10=completely interferes.|Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6|MITT||scores on a scale||Standard Error|Least Squares Mean
736498|NCT00442546|Secondary|Total Clinically Meaningful Event (CME) Score|CMEs were defined using OR-SDS (assesses subject-reported levels of severity concerning 10 symptoms associated with opioid medication usage: fatigue, drowsiness, inability to concentrate, nausea, dizziness, constipation, itching, difficulty with urination, confusion and retching/vomiting). CME = any symptom rated as severe or very severe, with the exception of confusion. Confusion was defined as a CME if the severity score was at least moderate. Total score = the sum of CMEs across symptoms. Each CME = 1 point. Total CME score ranges from 0 to 9.|24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Discharge, Week 2, Week 4, and Week 6/ET|MITT.||scores on a scale||Standard Error|Least Squares Mean
736499|NCT00442546|Secondary|The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Overall Composite Score|The OR-SDS assessed subject-reported levels of frequency, severity and degree of bother for 10 symptoms known to be associated with opioid medication usage: fatigue, drowsiness, inability to concentrate, nausea, dizziness, constipation, itching, difficulty with urination, confusion, retching and vomiting. The overall composite score was the average across frequency, severity, and degree of bother scores. Total possible score: 0 (better) to 4.34 (worse).|24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Discharge, Week 2, Week 4, Week 6/ET|MITT||scores on a scale||Standard Error|Least Squares Mean
736500|NCT00442546|Secondary|The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Degree of Bother Composite Score|The OR-SDS was used to assess subject-reported level of degree of bother concerning 10 symptoms known to be associated with opioid medication usage: fatigue, drowsiness, inability to concentrate, nausea, dizziness, constipation, itching, difficulty with urination, confusion, and retching/vomiting. Symptom degree of bother was rated as: 1=not at all, 2=a little bit, 3=somewhat, 4=quite a bit, or 5=very much. Average score for each symptom was calculated by taking the mean of patient-reported score. Total possible degree of bother score: 0 (less degree of bother) to 5 (greater degree of bother).|24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Discharge, Week 2, Week 4, Week 6/ET|MITT||scores on a scale||Standard Error|Least Squares Mean
736501|NCT00442546|Secondary|The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Severity Composite Score|The OR-SDS was used to assess subject-reported levels of severity concerning 10 symptoms known to be associated with opioid medication usage: fatigue, drowsiness, inability to concentrate, nausea, dizziness, constipation, itching, difficulty with urination, confusion, and retching/vomiting. Symptom severity was rated as: 1=slight, 2=moderate, 3=severe, or 4=very severe. The average score for each symptom was calculated by taking the mean of patient-reported score. Total possible severity score: 0 (less severe) to 4 (more severe).|24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Discharge, Week 2, Week 4, Week 6/ET|MITT||scores on a scale||Standard Error|Least Squares Mean
736502|NCT00442546|Secondary|The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the Opioid-Related Symptom Distress Scale (OR-SDS) - Frequency Composite Score|The OR-SDS was used to assess subject-reported levels of frequency concerning 10 symptoms known to be associated with opioid medication usage: fatigue, drowsiness, inability to concentrate, nausea, dizziness, constipation, itching, difficulty with urination, confusion, and retching/vomiting. Symptom frequency was rated as: 1=rarely, 2=occasionally, 3=frequently, or 4=almost constantly. The average score for each symptom was calculated by taking the mean of patient-reported score. Total possible frequency score: 0 (less frequent) to 4 (more frequent).|24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Discharge, Week 2, Week 4, Week 6/ET|MITT.||scores on a scale||Standard Error|Least Squares Mean
736503|NCT00442546|Secondary|Analgesics Used Post Discharge (Acetylsalicylic Acid) for the Pregabalin 300 mg and Placebo Treatment Groups at Week 6/ET|Week 6 total daily dose was calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period.|Week 6/ET|MITT||mg||Standard Error|Least Squares Mean
736504|NCT00442546|Secondary|Analgesics Used Post Discharge (Acetylsalicylic Acid) for the Pregabalin 150 mg and Placebo Treatment Groups at Week 6/ET|Week 6 total daily dose was calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period.|Week 6/ET|MITT||mg||Standard Error|Least Squares Mean
736505|NCT00442546|Secondary|Analgesics Used Post Discharge (Acetylsalicylic Acid) for the Pregabalin 300 mg Treatment Group at Week 4|Week 4 total daily dose was calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period.|Week 4|||mg||Standard Error|Least Squares Mean
736506|NCT00442546|Secondary|Analgesics Used Post Discharge (Acetylsalicylic Acid) for the Pregabalin 150 mg and Placebo Treatment Groups at Week 4|Week 4 total daily dose was calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period.|Week 4|MITT||mg||Full Range|Median
736507|NCT00442546|Secondary|Analgesics Used Post Discharge (Ibuprofen) for the Pregabalin 300 mg Treatment Group|Weeks 2, 4, and 6 total daily doses were calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period.|Week 2, Week 4, Week 6/ET|MITT. There were not enough subjects with data at Week 2 for Ibuprofen to calculate least squares mean values.||mg||Standard Error|Least Squares Mean
736508|NCT00442546|Secondary|Analgesics Used Post Discharge (Ibuprofen) for the Pregabalin 150 mg and Placebo Treatment Groups|Weeks 2, 4, and 6 total daily doses were calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period.|Week 2, Week 4, Week 6/ET|MITT. There were not enough subjects with data at Week 2 and Week 4 for Ibuprofen to calculate least squares mean values.||mg||Standard Error|Least Squares Mean
736509|NCT00442546|Secondary|Analgesics Used Post Discharge (Acetylsalicylic Acid [Week 2] and Paracetamol [Weeks 2, 4, and 6]|Weeks 2, 4, and 6 total daily doses were calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period.|Week 2, Week 4, Week 6/ET|MITT.||mg||Standard Error|Least Squares Mean
736510|NCT00442546|Secondary|Analgesics Used During the Hospital Stay (Acetylsalicylic Acid, Ketorolac, and Paracetamol)|Total dose for in-hospital visits was the total dose for the day.|24 hours, 48 hours, 72 hours|MITT. There were not enough subjects with data to calculate least squares mean values at 24 and 48 hours for Acetylalicyclic Acid and 72 hours for Ketorolac.||mg||Standard Error|Least Squares Mean
736511|NCT00442546|Secondary|Opioids Used Post Discharge|The amount of opioid use was calculated as mg of oral morphine equivalent and included opioids administered by any route (PCA pump, parenteral bolus, or oral). Weeks 2, 4, and 6 total daily doses were calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period. This outcome measure does not include pregabalin as it is not an opioid.|Week 2, Week 4, Week 6/Early Termination (ET)|MITT||mg of oral morphine equivalent||Standard Error|Least Squares Mean
736512|NCT00442546|Secondary|Cumulative Total Amount of Opioids Used During the Entire Hospital Stay|Total cumulative dose calculated as mg of oral morphine equivalent and included opioids given by any route (patient controlled analgesia [PCA] pump, parenteral bolus or oral). Results for daily total not including pregabalin (not an opioid). Statistical model included main effect of treatment group and center. 1 subject at 144 h, 300 mg=non-missing data. Due to small sample size (N=1, 300 mg; N=5, other groups) and large opioid consumption for another subject in same center, least squares mean (300 mg, 144 h) is negative.|24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours, 168 hours, 192 hours, 216 hours|MITT. There were not enough subjects with data at 168, 192, and 216 hours to calculate least squares mean values.||mg of oral morphine equivalent||Standard Error|Least Squares Mean
736549|NCT00442689|Primary|Change in High-density Lipoprotein (HDL) Levels During Study Period|Change in high-density lipoprotein (HDL) levels during study period (HDL level at study endpoint - baseline HDL)|6 months|||mg/dL||Standard Deviation|Mean
736513|NCT00442546|Primary|Subject Reported Worst Pain Score in Daily Diaries Using the Worst Pain Item of the Modified Brief Pain Inventory - Short Form (m-BPI-sf)|"The mBPI-SF is a self administered questionnaire developed to assess pain severity and pain interference with functional activities during a 24-hour period prior to evaluation. For the Worst Pain item of the m-BPI-sf scale (11 point Likert scale; range: 0 [no pain] to 10 [pain as bad as you can imagine]), subjects were asked to rate their pain by marking an X in one of the ten boxes that best described their pain at its worst in the last 24 hours post surgery and at least 12 hours after discontinuation of the peripheral nerve block or neuroaxial block."|48 hours after surgery|Modified Intent-to-Treat (MITT) Population=all ITT subjects who took 12 and 2 hours pre-surgery study medications, had no surgical or anesthetic complications during total knee replacement surgery and had at least 1 post surgery primary efficacy measurement.||scores on a scale||Standard Error|Least Squares Mean
736514|NCT00442559|Secondary|Change From Baseline for Daily Allergic Rhinitis Symptom Score|The score is an ordinal scale from 0 (no symptoms) to 3 (most symptoms). The change was calculated as the score at 12 weeks minus the score at baseline. Thus, a negative value for change from baseline indicates a favorable outcome.|Baseline and Week 12|The secondary efficacy parameter was a mean change from baseline to treatment for daily allergic rhinitis symptom score. Therefore 139 participants who didn't have a daily allergic rhinitis symptom score from the participant diary were not included.||Units on scale||Standard Deviation|Mean
736515|NCT00442559|Primary|Change From Baseline for Daytime Asthma Symptom Score|The score is an ordinal scale from 0 (no symptoms) to 5 (most symptoms). The change was calculated as the score at 12 weeks minus the score at baseline. Thus, a negative value for change from baseline indicates a favorable outcome.|Baseline and Week 12|The primary efficacy parameter was a mean change from baseline to treatment for daytime asthma symptom score. Therefore 138 participants who didn't have a daytime asthma symptom score from the participant diary were not included.||Units on scale||Standard Deviation|Mean
736516|NCT00442572|Secondary|Mean Change From Baseline in Triiodothyronine and Thyroxine|The Triiodothyronine (T3) and thyroxine (T4) values were planned to be calculated as arithmetic mean by treatment groups (PEGASYS and No Intervention).|Up to Week 108|Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.||picomole/liter||Standard Deviation|Mean
736517|NCT00442572|Secondary|Mean Change From Baseline in Thyroid Stimulating Hormone (TSH)|The TSH was planned to be calculated as arithmetic mean by treatment groups (PEGASYS and No Intervention).|Up to Week 108|Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.||milli-international units/liter||Standard Deviation|Mean
736518|NCT00442572|Secondary|Mean Change From Baseline in Blood Glucose|The blood glucose was measured for change from baseline. All blood glucose values were planned to be calculated as arithmetic mean by treatment groups (PEGASYS and No Intervention).|Up to Week 108|Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.||millimoles/ liter||Standard Deviation|Mean
736519|NCT00442572|Secondary|Mean Change From Baseline in Creatinine and Uric Acid|The creatinine and uric acid values were planned to be calculated as arithmetic mean by treatment groups (PEGASYS and No Intervention).|Up to Week 108|Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.||micromole/liter||Standard Deviation|Mean
736520|NCT00442572|Secondary|Mean Change From Baseline in Blood Urea|The blood urea was planned to be calculated as arithmetic mean by treatment groups (PEGASYS and No Intervention).|Up to Week 108|Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.||millimoles/liter||Standard Deviation|Mean
736521|NCT00442572|Secondary|Mean Change From Baseline in Bilirubin Indirect and Bilirubin Direct|The laboratory parameters included bilirubin indirect and bilirubin direct. All laboratory parameters were planned to be calculated as arithmetic mean by treatment groups (PEGASYS and No Intervention).|Up to Week 108|Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.||milligrams/deciliter||Standard Deviation|Mean
736522|NCT00442572|Secondary|Mean Change From Baseline in Protein and Indirect Albumin|The clinical chemistry parameters included indirect protein and albumin. All laboratory parameters were planned to be calculated as arithmetic mean by treatment groups (PEGASYS and no intervention).|Up to Week 108|Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.||Gram/deciliter||Standard Deviation|Mean
736523|NCT00442572|Secondary|Mean Change From Baseline in Clinical Chemistry|The clinical chemistry parameters included alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT), gamma-glutamyl transferase (GGT), alkaline phosphatase (ALP). All laboratory parameters were planned to be calculated as arithmetic mean by treatment groups (PEGASYS and No Intervention).|Up to Week 108|Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.||Units/Litre||Standard Deviation|Mean
736524|NCT00442572|Secondary|Mean Change From Baseline in Hematology|The hematology parameters included erythrocytes, leucocytes, basophils, eosinophils, lymphocytes, monocytes, thrombocytes. All laboratory parameters were planned to be calculated as arithmetic mean by treatment groups (PEGASYS and No Intervention).|Up to Week 108|Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.||10^9/L||Standard Deviation|Mean
736525|NCT00442572|Secondary|Mean Change From Baseline in Hemoglobin|The hemoglobin values were planned to be calculated as arithmetic mean by treatment groups (PEGASYS and No Intervention).|Up to Week 108|Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.||Gram/deciliter||Standard Deviation|Mean
736526|NCT00442572|Secondary|Mean Change From Baseline in HBsAg Levels|An early decrease in HBsAg from baseline to Weeks 12 or 24 has been identified as further on-treatment predictor for sustained HBsAg clearance and virological response in HBeAg negative participants.|Up to Week 108|Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation. Data of participants available at the time of the assessment were included in the analysis.||copies/mL||95% Confidence Interval|Mean
736527|NCT00442572|Secondary|Fibrosis-4 and Aspartate Aminotransferase to Platelet Ratio Index Scores For Change in Liver Fibrosis|Fibrosis-4 (FIB-4) and Aspartate Aminotransferase to Platelet Ratio Index (APRI) are non-invasive scoring systems, which are calculated on the basis of laboratory tests that indicates the level of liver fibrosis. The APRI scores are calculated based on Aspartate Aminotransferase (AST) levels and platelet counts whereas FIB-4 scores are calculated based on platelets, ALT, AST and age. For APRI, the scores are interpreted as ≤ 0.5 is 81% sensitive and 50% specific for a diagnosis of significant fibrosis in chronic hepatitis C (CHC), where as a cut-off > 1.5 is 35% sensitive and 91% specific for the diagnosis of significant fibrosis. The majority of biomarker panels will produce inconclusive results for a proportion of participants falling within the indeterminate range (between 0.5 and 1.5) for a specific fibrosis end-point. For FIB-4, the scores are interpreted as FIB-4 score of < 1.45: absence of cirrhosis, FIB-4 score of 1.45 to 3.25: inconclusive, FIB-4 score > 3.25: cirrhosis.|Up to Week 108|Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.||Units on a scale||Full Range|Median
736528|NCT00442572|Secondary|Percentage of Participants With HBV DNA Levels Under the Lower Limit (Serum HBV DNA Level < 300 Copies/ml) For a Significant Quantity|HBV DNA level, or viral load, is an indicator of viral replication. Higher HBV DNA levels are usually associated with an increased risk of liver disease and hepatocellular carcinoma. HBV DNA level typically falls in response to effective antiviral treatment.|Up to Week 108|Safety population included all randomized participants who passed during at least one treatment period and had at least one efficacy and safety evaluation. HBV DNA levels below lower limit for significant quantity were not studied for no intervention arm participants.||Percentage of Participants||95% Confidence Interval|Number
736529|NCT00442572|Secondary|Percentage of Participants With HBsAg Seroconversion|The development of antibodies against HBsAg is known as HBsAg seroconversion. It signifies clearance of HBsAg and resolution of the chronic infection. НBsAg seroconversion is the final goal of anti-hepatitis B virus treatment and it is closest to the definition of “cure” but in practice it is very rare in HBeAg-negative chronic hepatitis B (CHB).|Up to Week 108|Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation. Data of participants available at the time of the assessment were included in the analysis. Only participants with HBsAg clearance were analyzed.||Percentage of Participants|||Number
736530|NCT00442572|Secondary|Percentage of Participants With Loss of Hepatitis B Surface Antigen|Loss of Hepatitis B Surface Antigen (HBsAg) was defined as change of detectable HBsAg from positive to negative.|Up to Week 108|Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.||Percentage of Participants||95% Confidence Interval|Number
736531|NCT00442572|Secondary|Percentage of Participants With Stable Virological and Biochemical Response|All participants who achieved virological response (serum HBV DNA < 20 000 copies/ml) and biochemical response (stable normalization of their alanine transaminase [ALT]) during the treatment cycle (after each 12 weeks) and after the follow-up period (24 weeks after the last treatment period).|Up to Week 108|Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.||Percentage of Participants||95% Confidence Interval|Number
736532|NCT00442572|Primary|Percentage of Participants With Stable Virological Response|Stable virological response is serum Hepatitis B virus deoxyribonucleic acid (HBV DNA) <20 000 copies/ml during the treatment (after each 12 weeks) and after the follow-up period (24 weeks after the last treatment period).|Up to Week 108|Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.||Percentage of Participants||95% Confidence Interval|Number
736533|NCT00442598|Secondary|Overall Survival|Time from initiation of study drug to death.|Median measured in months, until death or censorship at analysis.|||months||Full Range|Median
736534|NCT00442598|Secondary|Progression-free Survival|Time from initiation of study drug to disease progression or death on study|Median measured in months|||months||Full Range|Median
736535|NCT00442598|Secondary|Objective Response Rate|Objective response rate measured by RECIST v1.0|Duration of study, up to 18 weeks.|||participants|||Number
736536|NCT00442598|Primary|CA 125 Response Rate|Reduction in blood levels of CA 125 of >50% from baseline, confirmed at the next study cycle.|Duration of study, up to 18 weeks.|||participants|||Number
736544|NCT00442689|Primary|Change in Maximal Aerobic Exercise Capacity (VO2 Max) Over the Study Period|Change in maximal aerobic exercise capacity (VO2 max) over the study period (VO2 max at study endpoint - baseline VO2 max)|6 months|||L/min||Standard Deviation|Mean
736551|NCT00442702|Secondary|Participants With Adverse Events|Adverse events were collected during the treatment period (from the first treatment dose) up to 30 days after last dose or at least until the date of last contact if the date of last contact occurred after the specified 30 day period.|Randomization to Month 10 (final visit)|Safety population||participants|||Number
736552|NCT00442702|Secondary|Number of Participants With Red Blood Cell (RBC) Transfusions|Red blood cell (RBC) transfusions could be given during the treatment period in case of medical need, i.e., in severely anemic patients with recognized symptoms or signs of anemia (e.g., in patients with acute blood loss, with severe angina, or whose Hemoglobin decreased to critical levels). The number of participants who had at least one red blood cell transfusion during the entire study, during the Titration Period and during the Evaluation Period is presented. Participants who received more than one transfusion within a defined period are only counted once.|From randomization to Month 9|Safety population included all randomized patients who received at least one dose of trial medication and a safety follow-up, according to the treatment received.||participants|||Number
736553|NCT00442702|Secondary|Change in Hemoglobin Concentration From Baseline Over Time||From Baseline to 9 months; blood samples for hemoglobin measurements were taken twice a month, at each study visit.|"Intent-to-treat population, including all randomized patients. n refers to the number of patients for whom data was available at each time point."||g/dL||Standard Deviation|Mean
736554|NCT00442702|Primary|Change in Hemoglobin (Hb) Concentration From Baseline to the Evaluation Period|A time adjusted average baseline hemoglobin (Hb) concentration was calculated using the trapezoid rule from all available Hb measurements taken during the baseline period. The average evaluation period Hb concentration for each individual was calculated using the same method, from all their available measurements taken during the two month evaluation period. The change in Hb concentration between the baseline and evaluation periods was calculated by subtracting the baseline Hb from the evaluation period Hb. All blood samples for Hb measurements were taken prior to study drug administration.|Baseline (measurements at Week -4, Week -2 and Day 1) and Evaluation Period (Months 8 and 9; measurements twice a month and at the final visit).|Per Protocol population consisted of all randomized patients who had received at least one dose of trial medication and who have no major protocol violation. Data missing at the end of the evaluation period were handled using the last observation carried forward method (LOCF).||g/dL||Standard Deviation|Mean
736555|NCT00442897|Secondary|Number of Participants Reaching the LDL-C Goal (< 100 mg/dl) After 12 Weeks of Treatment|If patients didn't achieve LDL-C <100 mg/dl after 6 weeks of treatment, they received the double dosage of study drug for the next 6 weeks (vytorin 10/40 or atorvastatin 20 mg) and If achieved LDL-C < 100 mg/dl, they received the same dosage of study drug for the next 6 weeks.|After 12 weeks of the treatment|All patient treated (APT) approach||Participants|||Number
736556|NCT00442897|Primary|Number of Participants Reaching the LDL-C (Low Density Lipoprotein-Cholesterol) Goal (< 100 mg/dl) After 6 Weeks of Treatment|Primary objective is to evaluate the proportion of patients achieving LDL-C target <100 mg/dl recommend in National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) after 6 weeks of treatment(vytorin 10/20 vs. atorvastatin 10 mg)|After 6 weeks of treatment|The analysis used all patient treated (APT) approach which included all patients who had baseline measured right before randomization, have taken the study drug more than once after randomization and have one measurement after the initiation of the treatment.||Participants|||Number
736557|NCT00442936|Primary|Number of Participants Who Discontinue Study Drug Due to an AE|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Participants who took both active and placebo study drug were counted in the active group.|Up to 48 hours after first dose of study drug|The populaton consisted of all participants who received at least one dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken at the time of the AE.||Participants|||Number
736558|NCT00442936|Primary|Number of Participants Who Experience At Least One Adverse Event (AE)|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Participants were monitored for occurrence AEs for up to 14 days after last dose study drug. Participants who took both active and placebo study drug were counted in the active group.|Up to 14 days after last dose of study drug|The population consisted of all participants who received at least one dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken at the time of the AE.||Participants|||Number
736559|NCT00442936|Secondary|Number of Participants With Total Migraine Freedom (TMF) at 2 to 24 Hours Post-Dose|TMF at 2 to 24 hours post-dose is defined as TMF at 2 hours post-dose with no administration of either the optional second dose of study drug or any rescue medication between 2 and 24 hours post-dose, no return of mild/moderate/severe headache within 24 hours and no presence of phonophobia, photophobia, nausea or vomiting within 24 hours post-dose.|2 to 24 hours post-dose|The population consisted of all participants who were randomized, took at least one dose of study drug, recorded a baseline pain score, had at least one pain score measurement within 2 to 24 hours post-dose, and had at least one assessment for phonophobia, photophobia, nausea and vomiting within 2 to 24 hours post-dose.||Participants|||Number
736560|NCT00442936|Secondary|Number of Participants With Total Migraine Freedom (TMF) at 2 Hours Post-Dose|TMF at 2 hours post-dose is defined as PF at 2 hours post-dose without any of the following migraine-related symptoms: phonophobia, photophobia, nausea or vomiting at 2 hours post-dose.|2 hours post-dose|The population consisted of all participants who were randomized, took at least one dose of study drug, recorded a baseline pain score, had at least one pain score measurement within 2 hours post-dose, and had at least one assessment for phonophobia, photophobia, nausea and vomiting within 2 hours post-dose.||Participants|||Number
736561|NCT00442936|Secondary|Number of Participants With Sustained Pain Freedom (SPF) From 2 to 24 Hours Post-Dose|SPF is defined as PF at 2 hours post-dose with no return of mild/moderate/severe headache through 24 hours post-dose, and with no administration of either the optional second dose of study drug or any rescue medication between 2 and 24 hours post-dose.|2 to 24 hours post-dose|The population consisted of all participants who were randomized, took at least one dose of study drug, recorded a baseline pain score, had at least one pain score measurement within 2 hours post-dose, and had at least one pain score measurement at between 2 and 24 hours post-dose.||Participants|||Number
736562|NCT00442936|Primary|Number of Participants With Absence of Nausea at 2 Hours Post-Dose|Participants were asked if they experienced any nausea. The number of participants who experienced no nausea at 2 hours post-dose was determined.|2 hours post-dose|The population consisted of all participants who were randomized, took at least one dose of study drug, recorded a baseline nausea assessment, and had at least one nausea assessment within 2 hours post-dose.||Participants|||Number
736563|NCT00442936|Primary|Number of Participants With Absence of Phonophobia at 2 Hours Post-Dose|Participants were asked if they experienced any sensitivity to sound. The number of participants who experienced no phonophobia (sensitivity to sound) at 2 hours post-dose was determined.|2 hours post-dose|The population consisted of all participants who were randomized, took at least one dose of study drug, recorded a baseline phonophobia assessment, and had at least one phonophobia assessment within 2 hours post-dose.||Participants|||Number
736564|NCT00442936|Primary|Number of Participants With Absence of Photophobia at 2 Hours Post-Dose|Participants were asked if they experienced any sensitivity to light. The number of participants who experienced no photophobia (sensitivity to light) at 2 hours post-dose was determined.|2 hours post-dose|The population consisted of all participants who were randomized, took at least one dose of study drug, recorded a baseline photophobia assessment, and had at least one photophobia assessment within 2 hours post-dose.||Participants|||Number
736565|NCT00442936|Primary|Number of Participants With Pain Relief (PR) at 2 Hours Post-Dose|Participants were asked to rate their migraine headache severity with ratings of 0=No pain, 1=Mild pain, 2=Moderate pain, and 3=Severe pain. PR at 2 hours post-dose is defined as a shift from a moderate or severe migraine headache (Grade 2 or 3) at baseline to mild or no pain (Grade 1 or 0) at 2 hours post-dose.|2 hours post-dose|The population consisted of all participants who were randomized, took at least one dose of study drug, recorded a baseline pain score, and had at least one pain score measurement within 2 hours post-dose.||Participants|||Number
736566|NCT00442936|Primary|Number of Participants With Pain Freedom (PF) at 2 Hours Post-Dose|Participants were asked to rate their migraine headache severity with ratings of 0=No pain, 1=Mild pain, 2=Moderate pain, and 3=Severe pain. PF at 2 hours post-dose is defined as a decrease from a moderate or severe migraine headache (Grade 2 or 3) at baseline to no pain (Grade 0) at 2 hours post-dose.|2 hours post-dose|The population consisted of all participants who were randomized, took at least one dose of study drug, recorded a baseline pain score, and had at least one pain score measurement within 2 hours post-dose.||Participants|||Number
736567|NCT00442962|Secondary|Late Change in CD4 Count From Baseline|Change in CD4+ lymphocyte counts between week 48 study visit and baseline.|At week 48|Participants with a CD4+ lymphocyte cell count result from the week 48 study visit.||cells/mm^3||Standard Deviation|Mean
736568|NCT00442962|Secondary|Time to First Dose Modification|Time from starting study treatment to first dose/drug modification.|Throughout study|All enrolled participants who started study treatment.||weeks||95% Confidence Interval|Number
736569|NCT00442962|Secondary|Percentage of Participants With Late Virologic Suppression|Plasma HIV-1 Viral Load Fewer Than 50 Copies/ml|At Week 48|Participants with ultra-sensitive (detectable to 50 copies/mL) plasma HIV-1 RNA result available from week 48 visit.||percentage||95% Confidence Interval|Number
736570|NCT00442962|Secondary|Early Changes in CD4 Count From Baseline|Changes in CD4+ lymphocyte counts between study visit weeks 4, 8 16 and 24 and baseline.|At weeks 0(baseline), 4, 8, 16, 24|Intent to treat (study treatment status and history ignored); missing measurements ignored.||cells/mm^3||Standard Deviation|Mean
736571|NCT00442962|Secondary|Time to Loss of Virologic Response by Week 48 (Defined by FDA TLOVR Algorithm)||Throughout study|All enrolled participants included.||weeks||95% Confidence Interval|Number
736572|NCT00442962|Secondary|Time to Initial Virological Failure|Virologic failure defined as two consecutive measurements of plasma HIV-1 RNA at least 400 copies/mL at or after the week 16 study visit. Time measured from enrollment.|Throughout study|All participants enrolled are included.||weeks||95% Confidence Interval|Number
736573|NCT00442962|Secondary|Time to Initial Virologic Response|Time from enrollment to scheduled week of first plasma HIV-1 RNA viral load fewer than 400 copies/mL.|Throughout study|All enrolled participants included.||weeks||95% Confidence Interval|Number
736574|NCT00442962|Secondary|Percentage of Participants With Late Virologic Response|Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml|At Week 48|Participants with plasma HIV-1 RNA viral load result available from week 48 study visit.||percentage||95% Confidence Interval|Number
736575|NCT00442962|Secondary|Percentage of Participants With Early Virologic Suppression|Plasma HIV-1 Viral Load Fewer Than 50 Copies/ml|At Weeks 24|ITT (ignoring current study treatment status and history); missing values ignored and closest value to week 24 used if multiple results available. 2 fewer results available compared to primary outcome b/c testing by ultrasensitive assay may have been retrospective.||percentage of participants||95% Confidence Interval|Number
736576|NCT00442962|Secondary|Time to First Safety Event|Time from starting study treatment to first grade 3 or 4 sign/symptom or laboratory abnormality and at least one grade higher than baseline. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables.|Throughout study|All enrolled participants who started study treatment (which in this case, matches the number of participants enrolled.)||weeks||95% Confidence Interval|Number
736577|NCT00442962|Primary|Percentage of Participants With Early Virologic Response|Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml|At Week 24|Intention to treat (ignoring current study treatment status or history); closest measurement to week 24 used; missing measurements ignored. Exact binomial confidence interval calculated using method of Blyth-Still-Casella.||percentage of participants||95% Confidence Interval|Number
736578|NCT00443040|Secondary|Laboratory Values|Changes in laboratory values.|Daily for 38 days||||||
736579|NCT00443040|Secondary|Adverse Events|Adverse events grouped by body system|Daily for 38 days||||||
736580|NCT00443040|Secondary|Post-operative Analgesic Use||Daily for 38 days||||||
736581|NCT00443040|Secondary|Nasogastric Tube Re-insertion|Proportion of subjects with nasogastric tube re-insertion|Daily for 38 days||||||
736582|NCT00443040|Primary|Time to Return of Upper and Lower GI Function|The time to first bowel movement or the time to tolerating solid food, whichever occurs later.|Daily for 38 days|As the study was terminated early due to poor enrollment (31 of a planned 114 subjects were randomized and evaluable), no formal efficacy analyses were conducted.||hours||Standard Deviation|Mean
736583|NCT00443040|Secondary|Pain Score||Daily for 38 days||||||
736584|NCT00443040|Secondary|Vomiting Score||Daily for 38 days||||||
736590|NCT00443053|Secondary|Number of Any Adjudicated Bleeding Events at Days 47 and 77|The sum of adjudicated major bleeds, non-major clinically relevant bleeds, and minor bleeds was calculated. Minor bleeding was defined as other clinically overt bleeding events that did not meet the criteria for major or clinically relevant non-major bleeding. The revision of the Day 47 time point was to account for participants with treatment duration longer than 45 days. Adverse events were evaluated “On-Treatment,” defined as from randomization up to the last injection +4 days.|Days 47 (or last dose plus 4 days) and 77|As-Treated Population||events|||Number
736591|NCT00443053|Secondary|Number of Adjudicated Non-Major Bleeding Events at Days 47 and 77|Clinically relevant non-major bleeding was defined as clinically relevant bleeding that did not qualify as major but satisfied a priori criteria, and/or any bleeding that resulted in clinical consequences for a participant. The revision of the Day 47 time point was to account for participants with treatment duration longer than 45 days. Adverse events were evaluated “On-Treatment,” defined as from randomization up to the last injection +4 days.|Days 47 (or last dose plus 4 days) and 77|As-Treated Population||events|||Number
736592|NCT00443053|Secondary|Number of Adjudicated Major Bleeding Events and Deaths at Days 47 and 77|Major bleeding was defined as bleeding that was fatal and/or (1) in a critical area/organ (e.g., intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome); (2) associated with a fall in hemoglobin >=20 g/L (1.24 mmol/L); (3) led to a transfusion of >=2 units of packed red blood cells/whole blood. The revision of the Day 47 time point was to account for participants with treatment duration longer than 45 days. Adverse events were evaluated “On-Treatment,” defined as from randomization up to the last injection +4 days.|Days 47 (or last dose plus 4 days) and 77|As-Treated Population: randomized participants who received at least one dose of study treatment, as actually received||events|||Number
736593|NCT00443053|Secondary|Number of Participants Who Required Surgery to Treat Superficial Vein Thrombosis Recurrence at Days 47 and 77|The number of participants requiring surgery was measured.|Days 47 and 77|ITT Population||participants|||Number
736594|NCT00443053|Secondary|Number of Participants With at Least One Occurrence of Each Adjudicated Component of the Primary Efficacy Endpoint at Days (D) 47 and 77|VTE was defined as a composite of symptomatic DVT; symptomatic PE; symptomatic extension of SVT, defined as downstream progression of the initial SVT by at least 2 cm and to within <=3 cm from the sapheno-femoral junction; or symptomatic recurrence of SVT, defined as a new episode in any other superficial venous location, meeting the following criteria: the new SVT was in a different superficial vein and not directly contiguous upstream with the index SVT, or it was in the same superficial vein but clearly distinct from the index SVT with an open venous segment of at least 10 cm in length.|Days 47 and 77|ITT Population||participants|||Number
736595|NCT00443053|Secondary|Number of Participants With at Least One Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up to Day 77|VTE was defined as a composite of symptomatic deep-vein thrombosis (DVT), symptomatic pulmonary embolism (PE), symptomatic extension of superficial vein thrombosis (SVT), or symptomatic recurrence of SVT. All VTEs were confirmed by objective tests and then adjudicated by an independent central adjudication committee (CAC), whose members were blinded to treatment assignment.|Baseline to Day 77|ITT Population||participants|||Number
736596|NCT00443053|Primary|Number of Participants With at Least on Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up to Day 47|VTE was defined as a composite of symptomatic deep-vein thrombosis (DVT), symptomatic pulmonary embolism (PE), symptomatic extension of superficial vein thrombosis (SVT), or symptomatic recurrence of SVT. All VTEs were confirmed by objective tests and then adjudicated by an independent central adjudication committee (CAC), whose members were blinded to treatment assignment.|Baseline to Day 47|Intent-to-Treat (ITT) Population: all randomized participants||participants|||Number
736597|NCT00443118|Secondary|• Incidence of Intracranial Hemorrhage Grades 3-4 for Preterm Newborns <32 Weeks||1 day of life and 30 days after birth||||||
736598|NCT00443118|Secondary|Days on CPAP||after birth and during hospitalization up to four weeks|||days||Standard Deviation|Mean
736599|NCT00443118|Secondary|Days on Mechanical Ventilation||after delivery and before four weeks|||days||Standard Deviation|Mean
736600|NCT00443118|Secondary|• Need for Mechanical Ventilation or CPAP||during hospitalization|||participants|||Number
736601|NCT00443118|Secondary|Days on Oxygen||after birth and during hospitalization up to four weeks|||days||Standard Deviation|Mean
736602|NCT00443118|Secondary|• Use of Oxygen Treatment Beyond the Delivery Room||during hospitalization|||participants/|||Number
736603|NCT00443118|Secondary|• Incidence of Air Leaks|included pneumothorax and Pneumomediastinum|after birth and during hospitalization up to four weeks|||participants|||Number
736604|NCT00443118|Secondary|• Incidence of Neonatal Encephalopathy During First Week of Life (Classified by Sarnat)||first week of life|||participants|||Number
736605|NCT00443118|Secondary|Apgar Scores at 1 and 5 Minutes|categorized Apgar score 1 min <=3 and categorized Apgar score 5 min <=5 The Apgar score is applied routinely by nurses and neonatologists to describe how vigorous the baby is at birth, it ranges from 0 to 10, with higher scores representing better outcomes.|1-5 minutes of life|||participants|||Number
736606|NCT00443118|Secondary|• Need for Chest Compression and/or Medications||after 2 minutes of life|||participants|||Number
736607|NCT00443118|Secondary|• Proportion of Eligible Newborns Who Entered the Study and Who Were Intubated After Failure of PPV With Mask.||after 2 minutes of life|||percentage of participants|||Number
736608|NCT00443118|Secondary|• SpO2 Value at 2 Minutes of Life.||2 minutes of life|the pulse-oximeter was reliable at 2 minutes in 69% of the cases in both groups.||percentage of oxygen saturation||Standard Deviation|Mean
736609|NCT00443118|Secondary|Time the Newborn Takes to Reach a HR > 100 Bpm||2 minutes of life|||minutes||Inter-Quartile Range|Mean
736610|NCT00443118|Primary|Proportion of Infants With a HR ≥ 100 Bpm at 2 Minutes of Life.||2 minutes of life|The analysis was performed by intention to treat||percentage of participants|||Number
736648|NCT00443599|Secondary|Mortality at Hospital Discharge.|Mortality is assessed at hospital discharge and at 30 days.|Mortality at hospital discharge (In-hospital mortality) was evaluated on the day of hospital discharge or day of death from any cause, whichever came first (no upper limit).|||Participants|||Number
736611|NCT00443209|Secondary|Percentage of Participant Migraine Attacks With Pain Freedom (PF) at 2 Hours Post-Dose|Participants were asked to rate their migraine headache severity with ratings of 0=No pain, 1=Mild pain, 2=Moderate pain, and 3=Severe pain. PF at 2 hours post-dose is defined as a decrease from mild, moderate or severe migraine headache (Grade 1, 2, or 3) at baseline to no pain (Grade 0) 2 hours post-dose.|2 hours post-dose (Up to 18 months)|The Full Analysis Set (FAS) population consisted of all participants who were randomized and reported at least one treated migraine attack with at least one post-treatment efficacy evaluation.||Percentage of Migraine Attacks||Standard Deviation|Mean
736612|NCT00443209|Primary|Percentage of Participants With At Least One Vital Sign Measurement Outside Predefined Limits of Change|Predefined limits of change were established for vital sign measurements: Systolic Blood Pressure (>=180 mm Hg and 20 mm Hg increase OR <=90 mm Hg and 20 mm Hg decrease), Diastolic Blood Pressure (>=105 mm Hg and 15 mm Hg increase OR <=50 mm Hg and 15 mm Hg decrease), Pulse (>=120 beats per minute [bpm] and 15 bpm increase OR <=50 bpm and 15 bpm decrease), Body Temperature (>38º C [oral equivalent]) and Respiratory Rate (>25 or increase of 10 OR <5 or decrease of 10 [per minute]). Participants were monitored for vital sign measurements outside predefined limits of change for 14 days after any dose of study drug.|Within 14 days of any dose of study drug (Up to 18.5 months)|The APAT population consisted of all participants who received at least one dose of study drug.||Percentage of Participants|||Number
736613|NCT00443209|Primary|Percentage of Participants With At Least One Laboratory AE|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study product, is also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test. Participants were monitored for laboratory AEs for 14 days after any dose of study drug.|Within 14 days of any dose of study drug (Up to 18.5 months)|The APAT population consisted of all participants who received at least one dose of study drug.||Percentage of Participants|||Number
736614|NCT00443209|Primary|Percentage of Participants With At Least One Clinical AE|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study product, is also an AE. A clinical AE was an AE reported as a result of a clinical examination. Participants were monitored for clinical AEs for 14 days after any dose of study drug.|Within 14 days of any dose of study drug (Up to 18.5 months)|The APAT population consisted of all participants who received at least one dose of study drug.||Percentage of Participants|||Number
736615|NCT00443209|Primary|Percentage of Participants With At Least One Triptan-Related Adverse Experience (AE)|Triptan-related AEs are defined as: chest pain, chest tightness, asthenia, paraesthesia, dysaesthesia or hyperaesthesia. Participants were monitored for triptan-related AEs for 14 days after any dose of study drug.|Within 14 days of any dose of study drug (Up to 18.5 months)|The All-Patients-As-Treated (APAT) population consisted of all participants who received at least one dose of study drug.||Percentage of Participants|||Number
736616|NCT00443261|Primary|Evaluate the Safety and Toxicity of Azacitidine (5-azacytidine, Vidaza®) and Cisplatin Combination|Although response is not the primary endpoint of this trial, patients with measurable disease will by assessed by standard criteria. For the purpose of this study, patients should be re-evaluated every 8 weeks by imaging study. In addition to baseline scan, confirmatory scans will also be obtained 4 weeks following initial documentation of an objective response.|Weeks 1-12, 24, 36|The 1 patient enrolled in the study died after cycle 1 with rapidly progressing cancer. Therefore, no data to analyze for primary outcome measure.|||||
736617|NCT00443352|Primary|Change in Frequency of Migraine Days During the Last 28 Day Interval of the Treatment Period as Compared to the 28 Day Baseline Period.|Change in frequency of migraine days from day -28 to day 0 (28 days) was compared to frequency of migraine days from day 56-84 (final 28 days of study).|Change in frequency of migraine days from day -28 to day 0 (28 days) was compared to frequency of migraine days from day 56-84 (final 28 days of study).|Number of participants for analysis was modified intention to treat - anyone who took at least one dose of duloxetine||days||Standard Deviation|Mean
736618|NCT00443430|Secondary|Clinical Remission on Medication|6 months of clinical inactive disease|12 months or end of study|all participants receiving study medications||participants|||Number
736619|NCT00443430|Secondary|Safety Profiles, Including the Number of Treatment-emergent, Serious, or Unexpected Adverse Events and Other Important Medical Events||Over 12 months maximum study participation per subject|all participants that received study medications||events|||Number
736620|NCT00443430|Primary|Proportion of Participants Who Attain Inactive Disease by 6 Months||6 months after initiation of study intervention|all participants receiving study medications||participants|||Number
736621|NCT00443456|Other Pre-specified|Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value and Systolic Blood Pressure Had Decreased by 10 mmHg or More From Baseline in the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent|Target blood pressure reduction value in accordance with Japanese Society of Hypertension Guidelines for the Management of Hypertension 2004: For <= 64 years old: systolic blood pressure below 130 mmHg and diastolic blood pressure below 85 mmHg; For >= 65 years old: systolic blood pressure below 140 mmHg and diastolic blood pressure below 90 mmHg|8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks|Full Analysis Set, Observed Case, n=number of subjects with evaluable data in group with concomitant treatment, without concomitant treatment, respectively.||participants|||Number
736622|NCT00443456|Other Pre-specified|Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value in Treatment Groups With or Without Concomitant Antihypertensive Agent|Target blood pressure reduction value in accordance with Japanese Society of Hypertension Guidelines for the Management of Hypertension 2004: For <= 64 years old: systolic blood pressure below 130 mmHg and diastolic blood pressure below 85 mmHg; For >= 65 years old: systolic blood pressure below 140 mmHg and diastolic blood pressure below 90 mmHg|8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks|Full Analysis Set, Observed Case, n=number of subjects with evaluable data in group with concomitant treatment, without concomitant treatment, respectively.||participants|||Number
736623|NCT00443456|Primary|Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value and Systolic Blood Pressure Had Decreased by 10 mmHg or More From Baseline in the Preceding Study|Target blood pressure reduction value in accordance with Japanese Society of Hypertension Guidelines for the Management of Hypertension 2004: For <= 64 years old: systolic blood pressure below 130 mmHg and diastolic blood pressure below 85 mmHg; For >= 65 years old: systolic blood pressure below 140 mmHg and diastolic blood pressure below 90 mmHg|8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks|Full Analysis Set, Last Observation Carried Forward||participants|||Number
736624|NCT00443456|Primary|Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value|Target blood pressure reduction value in accordance with Japanese Society of Hypertension Guidelines for the Management of Hypertension 2004: For <= 64 years old: systolic blood pressure below 130 mmHg and diastolic blood pressure below 85 mmHg; For >= 65 years old: systolic blood pressure below 140 mmHg and diastolic blood pressure below 90 mmHg|8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks|Full Analysis Set, Last Observation Carried Forward||participants|||Number
736625|NCT00443456|Other Pre-specified|Change in Diastolic Blood Pressure From Baseline of This Long-term Study in Treatment Groups With or Without Concomitant Antihypertensive Agent|Value at each observation time point minus value at Week 8 (Week 8 was defined as baseline of this long-term study A0531086: NCT00443456.)|Week 8, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks|Full Analysis Set, Observed Case, n=number of subjects with evaluable data in group with concomitant treatment, without concomitant treatment, respectively.||mmHg||Standard Deviation|Mean
736626|NCT00443456|Other Pre-specified|Change in Diastolic Blood Pressure From Baseline of the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent|Value at each observation time point minus value at Week 0 (Week 0 was defined as baseline of the preceding study A0531085: NCT00415623.)|Week 0, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks|Full Analysis Set, Observed Case, n=number of subjects with evaluable data in group with concomitant treatment, without concomitant treatment, respectively.||mmHg||Standard Deviation|Mean
736627|NCT00443456|Other Pre-specified|Change in Systolic Blood Pressure From Baseline of This Long-term Study in Treatment Groups With or Without Concomitant Antihypertensive Agent|Value at each observation time point minus value at Week 8 (Week 8 was defined as baseline of this long-term study A0531086: NCT00443456.)|Week 8, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks|Full Analysis Set, Observed Case, n=number of subjects with evaluable data in group with concomitant treatment, without concomitant treatment, respectively.||mmHg||Standard Deviation|Mean
736628|NCT00443456|Other Pre-specified|Change in Systolic Blood Pressure From Baseline of the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent|Value at each observation time point minus value at Week 0 (Week 0 was defined as baseline of the preceding study A0531085: NCT00415623.)|Week 0, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks|Full Analysis Set, Observed Case, n=number of subjects with evaluable data in group with concomitant treatment, without concomitant treatment, respectively.||mmHg||Standard Deviation|Mean
736629|NCT00443456|Primary|Change in Diastolic Blood Pressure From Baseline of This Long-term Study|Value at each observation time point minus value at Week 8 (Week 8 was defined as baseline of this long-term study A0531086: NCT00443456.)|Week 8, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks|Full Analysis Set, Last Observation Carried Forward||mmHg||Standard Deviation|Mean
736630|NCT00443456|Primary|Change in Diastolic Blood Pressure From Baseline of the Preceding Study|Value at each observation time point minus value at Week 0 (Week 0 was defined as baseline of the preceding study A0531085: NCT00415623.)|Week 0, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks|Full Analysis Set, Last Observation Carried Forward||mmHg||Standard Deviation|Mean
736631|NCT00443456|Primary|Change in Systolic Blood Pressure From Baseline of This Long-term Study|Value at each observation time point minus value at Week 8 (Week 8 was defined as baseline of this long-term study A0531086: NCT00443456.)|Week 8, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks|Full Analysis Set, Last Observation Carried Forward||mmHg||Standard Deviation|Mean
736632|NCT00443456|Primary|Change in Systolic Blood Pressure From Baseline of the Preceding Study|Value at each observation time point minus value at Week 0 (Week 0 was defined as baseline of the preceding study A0531085: NCT00415623.)|Week 0, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks|Full Analysis Set, Last Observation Carried Forward||mmHg||Standard Deviation|Mean
736633|NCT00443534|Other Pre-specified|Time to Tumor Progression (TTP)|Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever comes first. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]).|Baseline, every 2 months until objective tumor progression or up to 2 years after the last dose of study medication|Tumor response data were not formally analyzed in this study as individual participant outcomes contributed to conclusions in their prior studies.|||||
736634|NCT00443534|Other Pre-specified|Progression-Free Survival (PFS)|"Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Baseline, every 2 months until objective tumor progression or death or up to 2 years after the last dose of study medication|Tumor response data were not formally analyzed in this study as individual participant outcomes contributed to conclusions in their prior studies.|||||
738611|NCT00450749|Primary|Change in Serum Lycopene Concentration|The differences in the mean of the 6 week (± 1 week) serum lycopene concentrations after adjusting for baseline serum lycopene concentrations calculated between the three arms, together with 95% confidence intervals.|Baseline and at 4-7 weeks||||||
736635|NCT00443534|Other Pre-specified|Overall Survival (OS)|Time in weeks from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Baseline, every 2 months until death or up to 2 years after the last dose of study treatment|Tumor response data were not formally analyzed in this study as individual participant outcomes contributed to conclusions in their prior studies.|||||
736636|NCT00443534|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to Day 28 after last dose of study treatment|Intent to treat (ITT) population included all enrolled participants who received at least 1 dose of study treatment.||participants|||Number
736637|NCT00443560|Secondary|Duration of Labor Analgesia|Time in minutes from initiation of labor analgesia until delivery of the infant|Time form initiation of labor analgesia to delivery (up to 24 hours)|Analysis was per protocal||minutes||Inter-Quartile Range|Median
736638|NCT00443560|Secondary|Number of Participants With Breakthrough Pain in the First Stage of Labor|Pain not responding to epidural analgesia in the first stage of labor was treated with bolus dose of bupivacaine 1.25 mg/mL or lidocaine 10 mg/mL, 10 to 15 mL. If pain relief was obtained the infusion concentration was increased. If the patient had no pain relief following the bolus injection, the epidural catheter was replaced.|Supplemental analgesia in first stage of labor (<24 hours)|Analysis was per protocol||participants|||Number
736639|NCT00443560|Primary|Number of Parturients With a Decrease in the Infusion of Epidural Analgesia During Second Stage of Labor|At the request of the obstetric provider, second stage analgesia density was decreased by decreasing the basal infusion rate if there was dissatisfaction with the progress of labor or a perceived inability to push. The basal infusion was never totally discontinued.|Second stage of labor up to 3 hours|Analysis was per protocal||participants|||Number
736640|NCT00443599|Secondary|Neurodevelopmental Evaluation, Motor|"Neurodevelopmental follow-up includes in-person testing using the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III), measured at one year of age.
Bayley-III cognitive composite score ranges from 55-145, Bayley-III language composite score ranges from 47-153, and Bayley-III motor composite score ranges from 46-154.
Higher values indicate better neurodevelopmental outcomes.
These three composite scores cannot be combined and are presented as separate scores in the literature."|Measured at one year of age.|Participants were not eligible if: born before 3/1/2008 (1 year before start of testing); age greater than one year at time of surgery; died; lived abroad; parent/guardian declined; severe disability precluded testing; did not show for testing; testing completed at greater than 18 months post eligibility.||Scores on a scale||Standard Deviation|Mean
736641|NCT00443599|Secondary|Neurodevelopmental Evaluation, Language|"Neurodevelopmental follow-up includes in-person testing using the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III), measured at one year of age.
Bayley-III cognitive composite score ranges from 55-145, Bayley-III language composite score ranges from 47-153, and Bayley-III motor composite score ranges from 46-154.
Higher values indicate better neurodevelopmental outcomes.
These three composite scores cannot be combined and are presented as separate scores in the literature."|Measured at one year of age.|Participants were not eligible if: born before 3/1/2008 (1 year before start of testing); age greater than one year at time of surgery; died; lived abroad; parent/guardian declined; severe disability precluded testing; did not show for testing; testing was completed at greater than 18 months post eligibility.||Scores on a scale||Standard Deviation|Mean
736642|NCT00443599|Secondary|Neurodevelopmental Evaluation, Cognitive|"Neurodevelopmental follow-up includes in-person testing using the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III), measured at one year of age.
Bayley-III cognitive composite score ranges from 55-145, Bayley-III language composite score ranges from 47-153, and Bayley-III motor composite score ranges from 46-154.
Higher values indicate better neurodevelopmental outcomes.
These three composite scores cannot be combined and are presented as separate scores in the literature."|Measured at one year of age.|Participants were not eligible if: born before 3/1/2008 (1 year before start of testing); age greater than one year at time of surgery; died; lived abroad; parent/guardian declined; severe disability precluded testing; did not show for testing; testing completed at greater than 18 months post eligibility.||Scores on a scale||Standard Deviation|Mean
736643|NCT00443599|Secondary|Nutritional Status|Nutritional status assessed by percentage of total caloric intake as enteral nutrition during critical illness period.|The percentage of total caloric intake was evaluated from the day of postoperative cardiac ICU admission until the last day of the critical illness period, as defined by the presence of the arterial catheter, assessed up to 30 days.|Nutritional intake was tracked during the period of critical illness, as defined by the presence of an arterial catheter.||Percent of total caloric intake||Inter-Quartile Range|Median
736644|NCT00443599|Secondary|Endocrine Function|Endocrine function is assessed by total triiodothyronine (T3) on post-operative day 7.|Measured during participant’s ICU stay on Day 7.|Thyroid hormones were assayed only if the participant remained in the cardiac ICU and there was central venous or arterial access for blood sampling.||ng/dL||Inter-Quartile Range|Median
736645|NCT00443599|Secondary|Immune Function|Immune function is assessed by C-reactive protein (CRP) on post-operative day 7.|Post-operative day 7.|Participants analyzed include those with adequate access for blood sampling, C-reactive protein (CRP) drawn on post-operative day 7 and successful processing and preparation of samples,||mg/dL||Inter-Quartile Range|Median
736646|NCT00443599|Secondary|Cardiac Function|Cardiac function is assessed by duration of vasoactive support.|The duration of vasoactive support was evaluated from the day of postoperative cardiac ICU admission until the last day of vasoactive support or day of death from any cause, whichever came first, assessed up to 30 days.|||Days||Inter-Quartile Range|Median
736647|NCT00443599|Secondary|Mortality at 30 Days.|Mortality is assessed at hospital discharge and at 30 days. If the participant is discharged from the hospital prior to 30 days, status is determined by a follow-up phone call to the family.|Measured at 30 days.|This outcome was not measured for participants lost to follow-up at 30 days post cardiac surgery.||Participants|||Number
736649|NCT00443599|Secondary|Duration of Endotracheal Intubation|Duration of endotracheal intubation spans from endotracheal tube intubation/initiation of mechanical ventilation to endotracheal tube extubation.|The duration of endotracheal intubation (mechanical ventilation) was evaluated from the day of postoperative cardiac ICU admission until the day of extubation or day of death from any cause, whichever came first, assessed up to 30 days.|||Days||Inter-Quartile Range|Median
736650|NCT00443599|Secondary|Duration of Hospital Stay|Duration of hospital stay spans from post-operative cardiac ICU admission to hospital discharge.|The duration of hospital stay was evaluated from the day of postoperative cardiac ICU admission until the day of hospital discharge or day of death from any cause, whichever came first, assessed up to 30 days.|||Days||Inter-Quartile Range|Median
736651|NCT00443599|Secondary|Duration of ICU Stay|Duration of ICU stay spans from post-operative cardiac ICU admission to cardiac ICU discharge.|The duration of cardiac ICU stay was evaluated from the date of postoperative cardiac ICU admission until the date of cardiac ICU discharge or date of death from any cause, whichever came first, assessed up to 30 days.|||Days||Inter-Quartile Range|Median
736652|NCT00443599|Secondary|Cardiac Index (CI)|Cardiac index is a measure of cardiac function, relating the cardiac output from the left ventricle in one minute to body surface area. It is calculated using the Fick principle, using oxygen consumption measured with a metabolic cart, hemoglobin levels, and the difference between arterial and superior vena cava oxygen saturation measured by co-oximetry.|Day 2 (day after cardiopulmonary bypass surgery).|This outcome (using indirect calorimetry) was not available at the Michigan site, and not captured in Boston participants A) who had been extubated or were receiving only pressure support ventilation, B) without a properly placed catheter allowing for a true mixed venous sample or C) for whom equipment malfunction precluded an accurate measurement.||liters/min/m^2||Inter-Quartile Range|Median
736653|NCT00443599|Primary|Incidence of Nosocomial Infections in the Cardiac ICU|Nosocomial infections that are attributable to the subject's stay in the Cardiac ICU, according to Center for Disease Control-defined criteria. These definitions are extensive and cannot be accurately condensed to fit within this space. Current CDC/NHSN criteria may be accessed through this URL: https://www.cdc.gov/nhsn/pdfs/pscmanual/17pscnosinfdef_current.pdf.|Measured during participant's ICU stay, a median duration of 3 days.|||infections / 1000 pt days|||Number
736654|NCT00443651|Secondary|Health Assessment Questionnaire-Disability Index (HAQ-DI) Change From Baseline at Weeks 24 and 48|The HAQ-DI assesses how well the patient is able to perform 8 activities: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. The patient answers 20 questions with 1 of 4 responses with the past week as the time frame: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The highest score for any question in a category determines the category score. The total score ranges from 0 (no disability) to 3 (completely disabled). A negative change score indicates improvement.|Baseline to Week 24 and Week 48|Safety population: All patients who were enrolled in the study and received any study drug (rituximab).||Units on a scale||Standard Deviation|Mean
736655|NCT00443651|Secondary|Percentage of Patients With European League Against Rheumatism (EULAR) Good and Moderate Responses at Weeks 24 and 48|Improvement in the post-baseline DAS 28-ESR score from baseline was used to determine the EULAR responses of moderate response and good response. The DAS 28-ESR score ranges from 0 to 10, with higher scores indicating more rheumatoid arthritis. For a post-baseline score ≤ 3.2, an improvement > 0.6 to ≤ 1.2 was a moderate response and ≥ 1.2 a good response. For a post-baseline score > 3.2 to ≤ 5.1, an improvement > 0.6 was a moderate response. For a post-baseline score > 5.1, an improvement ≥ 1.2 was a moderate response. A good response could not be achieved for post-baseline scores > 3.2.|Baseline to Week 24 and Week 48|Safety population: All patients who were enrolled in the study and received any study drug (rituximab).||Percentage of participants|||Number
736656|NCT00443651|Secondary|Percentage of Patients Achieving Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS 28-ESR) Remission and DAS 28-ESR Low Disease Activity Scores at Weeks 24 and 48|DAS 28-ESR was calculated using counts of tender and swollen joints (28 joints, 28TJC and 28SJC), a patient assessment (PA) of disease activity (DA) in previous 24 hours on a visual analog scale (no DA to maximum DA), and ESR at the current visit, using the following formula: 0.56 × 28TJC + 0.28 × 28SJC + 0.70 × ln(ESR) + 0.014 × PADA. The DAS 28-ESR score ranges from 0 to 10, with higher scores indicating more rheumatoid arthritis. DAS28-ESR Remission was defined as a DAS 28-ESR score of < 2.6. DAS28-ESR Low Disease Activity was defined as a DAS28-ESR score of ≤ 3.2.|Week 24 and Week 48|Safety population: All patients who were enrolled in the study and received any study drug (rituximab). There were 401 patients in the rituximab 1000 mg and 176 patients in the 500 mg safety populations. n = number of patients with non-missing DAS28-ESR last observation carried forward scores at Weeks 24 and 48 in the safety populations.||Percentage of participants|||Number
736657|NCT00443651|Secondary|Percentage of Patients With an Improvement of 20%, 50%, and 70% in American College of Rheumatology (ACR) Scores (ACR20/50/70) From Baseline at Weeks 24 and 48|Improvement must be seen in tender and swollen joint counts and in at least 3 of the following 5 parameters. Patient and physician assessment of patient disease activity (DA) in previous 24 hours on a visual analog scale (VAS, no DA to maximum DA); patient assessment of pain in previous 24 hours on a VAS (none to unbearable); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and C reactive protein or, if missing, erythrocyte sedimentation rate.|Baseline to Week 24 and Week 48|Safety population: All patients who were enrolled in the study and received any study drug (rituximab).||Percentage of participants|||Number
736658|NCT00443651|Secondary|Percentage of Patients Who Developed a Serious Adverse Event (SAE) Within 24 Weeks After Receiving the Second Course (Optional Retreatment) of Rituximab Treatment|An adverse event (AE) is any unfavorable and unintended sign, symptom, significantly abnormal laboratory finding, or disease temporally associated with the use of an investigational medical product or other protocol-imposed intervention. An AE was classified as an SAE if it: Resulted in death, persistent or significant disability/incapacity, or congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the investigational product; required or prolonged inpatient hospitalization; was life-threatening or considered a significant medical event by the investigator.|From start of the second course of rituximab treatment through Week 48|Safety population: All patients who were enrolled in the study and received any study drug (rituximab).||Percentage of participants|||Number
736659|NCT00443651|Secondary|Percentage of Patients Who Developed a Serious Adverse Event (SAE) During or Within 24 Hours of Rituximab Infusions|The percentage of patients developing a SAE during or within 24 hours of a rituximab infusion is reported separately for each of the 2 infusions in the first course of treatment (Days 1 and 15) and the second course of treatment (optional retreatment during Weeks 24 to 40). See the Primary Outcome Measure for a definition of a SAE.|From start of rituximab treatment through 24 hours|Safety population: All patients who were enrolled in the study and received any study drug (rituximab).||Percentage of participants|||Number
736660|NCT00443651|Primary|Percentage of Patients Developing a Serious Adverse Event (SAE) Within 24 Weeks After Receiving the First Course of Rituximab Treatment|An adverse event (AE) is any unfavorable and unintended sign, symptom, significantly abnormal laboratory finding, or disease temporally associated with the use of an investigational medical product or other protocol-imposed intervention. An AE was classified as an SAE if it: Resulted in death, persistent or significant disability/incapacity, or congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the investigational product; required or prolonged inpatient hospitalization; was life-threatening or considered a significant medical event by the investigator.|From first treatment with rituximab (Day 1) through Week 24|Safety population: All patients who were enrolled in the study and received any study drug (rituximab).||Percentage of participants|||Number
736661|NCT00443703|Secondary|Median Percent Change From Baseline in Serum Triglyceride at Week 24|Standard Deviation (Robust): calculated as interquartile range (IQR)/1.075, where IQR=3rd quartile-1st quartile.|Baseline and Week 24|Patients who had both baseline and at least one post-baseline measurement were included in the analysis||Percent Change||Standard Deviation|Median
736662|NCT00443703|Secondary|Mean Percent Change From Baseline in Fasting Serum High-Density Lipoprotein Cholesterol (HDL-C) at Week 24||Baseline and Week 24|Patients who had both baseline and at least one post-baseline measurement were included in the analysis||Percent Change||Standard Deviation|Mean
736663|NCT00443703|Secondary|Mean Percent Change From Baseline in Fasting Serum Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24||Baseline and Week 24|Patients who had both baseline and at least one post-baseline measurement were included in the analysis||Percent Change||Standard Deviation|Mean
736664|NCT00443703|Secondary|Mean Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24||Baseline and Week 24|Patients who had both baseline and at least one post-baseline measurement were included in the analysis||Percent Change||Standard Deviation|Mean
736665|NCT00443703|Secondary|Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 24||Baseline and Week 24|Patients who had both baseline and at least one post-baseline measurement were included in the analysis||Percent Change||Standard Deviation|Mean
736666|NCT00443703|Primary|Median Percent Change From Baseline in Serum Triglyceride at Week 12|Standard Deviation (Robust): calculated as interquartile range (IQR)/1.075, where IQR=3rd quartile-1st quartile.|Baseline and Week 12|Patients who had both baseline and at least one post-baseline measurement were included in the analysis||Percent Change||Standard Deviation|Median
736667|NCT00443703|Primary|Mean Percent Change From Baseline in Fasting Serum High-Density Lipoprotein Cholesterol (HDL-C) at Week 12||Baseline and Week 12|Patients who had both baseline and at least one post-baseline measurement were included in the analysis||Percent Change||Standard Deviation|Mean
736668|NCT00443703|Primary|Mean Percent Change From Baseline in Fasting Serum Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12||Baseline and Week 12|Patients who had both baseline and at least one post-baseline measurement were included in the analysis||Percent Change||Standard Deviation|Mean
736669|NCT00443703|Primary|Mean Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12||Baseline and Week 12|Patients who had both baseline and at least one post-baseline measurement were included in the analysis||Percent Change||Standard Deviation|Mean
736670|NCT00443703|Primary|Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 12||Baseline and Week 12|Patients who had both baseline and at least one post-baseline measurement were included in the analysis||Percent Change||Standard Deviation|Mean
736671|NCT00443703|Other Pre-specified|Number of Patients That Discontinued With Drug Related LAEs Through 24 Weeks|Number of patients that discontinued with drug-related (as assessed by an investigator who is a qualified physician, according to his or her clinical judgement) LAEs.|24 Week last patient last visit|All patients who took study medication were included in the analysis||participants|||Number
736672|NCT00443703|Other Pre-specified|Number of Patients That Discontinued Due to LAEs Through 24 Weeks||24 Week last patient last visit|All patients who took study medication were included in the analysis||participants|||Number
736673|NCT00443703|Other Pre-specified|Number of Patients With Serious LAEs Through 24 Weeks|Serious LAEs are any LAEs occurring at any dose that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose|24 Week last patient last visit|All patients who took study medication were included in the analysis||participants|||Number
736674|NCT00443703|Other Pre-specified|Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) Through 24 Weeks|Patients with drug-related (as assessed by an investigator who is a qualified physician, according to his/her best clinical judgement) LAEs|24 Week last patient last visit|All patients who took study medication were included in the analysis||participants|||Number
736675|NCT00443703|Other Pre-specified|Number of Patients With Laboratory Adverse Experiences (LAEs) Through 24 Weeks|A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S (Merck & Co., Inc.) product, whether or not considered related to the use of the product|24 Week last patient last visit|All patients who took study medication were included in the analysis||participants|||Number
736676|NCT00443703|Other Pre-specified|Number of Patients That Discontinued Due to Drug Related CAEs Through 24 Weeks||24 Week last patient last visit|All patients who took study medication were included in the analysis||participants|||Number
736677|NCT00443703|Other Pre-specified|Number of Patients That Discontinued Due to CAEs Through 24 Weeks||24 Week last patient last visit|All patients who took study medication were included in the analysis||participants|||Number
736678|NCT00443703|Other Pre-specified|Number of Patients That Died by 24 Week Last Patient Last Visit||24 Week last patient last visit|All patients who took study medication were included in the analysis||participants|||Number
736679|NCT00443703|Other Pre-specified|Number of Patients With Serious Drug-related CAEs Through 24 Weeks|Serious CAEs are any AEs occurring at any dose that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. Drug-related are as assessed by an investigator who is a qualified physician, according to his/her best clinical judgement|24 Week last patient last visit|All patients who took study medication were included in the analysis||participants|||Number
736680|NCT00443703|Other Pre-specified|Number of Patients With Drug-related CAEs Through 24 Weeks|Patients with drug-related (as assessed by an investigator who is a qualified physician, according to his/her best clinical judgement) CAEs.|24 Week last patient last visit|All patients who took study medication were included in the analysis||participants|||Number
736681|NCT00443703|Other Pre-specified|Number of Patients With Serious CAEs Through 24 Weeks|Serious CAEs are any AEs occurring at any dose that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose|24 Week last patient last visit|All patients who took study medication were included in the analysis||participants|||Number
736682|NCT00443703|Primary|Number of Patients With Clinical Adverse Experiences (CAEs) Through 24 Weeks|An adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S (Merck & Co., Inc.) product, whether or not considered related to the use of the product|24 Week last patient last visit|All patients who took study medication were included in the analysis||Participants|||Number
736683|NCT00443703|Primary|Number of Patients With Plasma Human Immunodeficiency Virus (HIV) RiboNucleic Acid (RNA) <50 Copies/mL at Week 24||Week 24|Full analysis set; two patients were excluded from the analysis because they did not have an HIV RNA test performed at Week 24 but had a test result of HIV RNA <50 copies/mL at Week 12 and Week 36.||Participants|||Number
736684|NCT00443729|Secondary|Median Percent Change From Baseline in Serum Triglyceride at Week 24|Standard Deviation (Robust): calculated as interquartile range (IQR)/1.075, where IQR=3rd quartile-1st quartile.|Baseline and Week 24|Patients who had both baseline and at least one post-baseline measurement were included in the analysis||Percent Change||Standard Deviation|Median
736685|NCT00443729|Secondary|Mean Percent Change From Baseline in Fasting Serum High-density Lipoprotein Cholesterol (HDL-C) at Week 24||Baseline and Week 24|Patients who had both baseline and at least one post-baseline measurement were included in the analysis||Percent Change||Standard Deviation|Mean
736686|NCT00443729|Secondary|Mean Percent Change From Baseline in Fasting Serum Low-density Lipoprotein Cholesterol (LDL-C) at Week 24||Baseline and Week 24|Patients who had both baseline and at least one post-baseline measurement were included in the analysis||Percent Change||Standard Deviation|Mean
736687|NCT00443729|Secondary|Mean Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at Week 24||Baseline and Week 24|Patients who had both baseline and at least one post-baseline measurement were included in the analysis||Percent Change||Standard Deviation|Mean
736688|NCT00443729|Secondary|Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 24||Baseline and Week 24|Patients who had both baseline and at least one post-baseline measurement were included in the analysis||Percent Change||Standard Deviation|Mean
736689|NCT00443729|Primary|Median Percent Change From Baseline in Serum Triglyceride at Week 12|Standard Deviation (Robust): calculated as interquartile range (IQR)/1.075, where IQR=3rd quartile-1st quartile.|Baseline and Week 12|Patients who had both baseline and at least one post-baseline measurement were included in the analysis||Percent Change||Standard Deviation|Median
736690|NCT00443729|Primary|Mean Percent Change From Baseline in Fasting Serum High-density Lipoprotein Cholesterol (HDL-C) at Week 12||Baseline and Week 12|Patients who had both baseline and at least one post-baseline measurement were included in the analysis||Percent Change||Standard Deviation|Mean
736691|NCT00443729|Primary|Mean Percent Change From Baseline in Fasting Serum Low-density Lipoprotein Cholesterol (LDL-C) at Week 12||Baseline and Week 12|Patients who had both baseline and at least one post-baseline measurement were included in the analysis||Percent Change||Standard Deviation|Mean
736692|NCT00443729|Primary|Mean Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at Week 12||Baseline and Week 12|Patients who had both baseline and at least one post-baseline measurement were included in the analysis||Percent Change||Standard Deviation|Mean
736693|NCT00443729|Primary|Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 12||Baseline and Week 12|Patients who had both baseline and at least one post-baseline measurement were included in the analysis||Percent Change||Standard Deviation|Mean
736694|NCT00443729|Other Pre-specified|Number of Patients That Discontinued Due to LAEs Through 24 Weeks||24 Week last patient last visit|All patients who took study medication were included in the analysis||Participants|||Number
736695|NCT00443729|Other Pre-specified|Number of Patients With Serious LAEs Through 24 Weeks|Serious LAEs are any LAEs occurring at any dose that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose|24 Week last patient last visit|All patients who took study medication were included in the analysis||Participants|||Number
736696|NCT00443729|Other Pre-specified|Number of Patients With Drug-related LAEs Through 24 Weeks||24 Week last patient last visit|All patients who took study medication were included in the analysis||Participants|||Number
736697|NCT00443729|Other Pre-specified|Number of Patients With Laboratory Adverse Experiences (LAEs) Through 24 Weeks||24 Week last patient last visit|All patients who took study medication were included in the analysis||Participants|||Number
736698|NCT00443729|Other Pre-specified|Number of Patients That Discontinued Due to CAEs Through 24 Weeks||24 Week last patient last visit|All patients who took study medication were included in the analysis||Participants|||Number
736699|NCT00443729|Other Pre-specified|Number of Patients That Died by 24 Week Last Patient Last Visit||24 Week last patient last visit|All patients who took study medication were included in the analysis||Participants|||Number
736700|NCT00443729|Other Pre-specified|Number of Patients With Serious Drug-related CAEs Through 24 Weeks|Serious CAEs are any AEs occurring at any dose that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. Drug-related are as assessed by an investigator who is a qualified physician, according to his/her best clinical judgement|24 Week last patient last visit|All patients who took study medication were included in the analysis||Participants|||Number
736701|NCT00443729|Other Pre-specified|Number of Patients With Drug-related CAEs Through 24 Weeks|Patients with drug-related (as assessed by an investigator who is a qualified physician, according to his/her best clinical judgement) CAEs.|24 Week last patient last visit|All patients who took study medication were included in the analysis||Participants|||Number
736702|NCT00443729|Other Pre-specified|Number of Patients With Serious CAEs Through 24 Weeks|Serious CAEs are any AEs occurring at any dose that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose|24 Week last patient last visit|All patients who took study medication were included in the analysis||Participants|||Number
736703|NCT00443729|Primary|Number of Patients With Clinical Adverse Experiences (CAEs) Through 24 Weeks||24 Week last patient last visit|All patients who took study medication were included in the analysis||Participants|||Number
736704|NCT00443729|Primary|Number of Patients With Plasma Human Immunodeficiency Virus (HIV) RiboNucleic Acid (RNA) <50 Copies/mL at Week 24||24 Weeks|Full analysis set; one patient was excluded from the analysis because they did not have an HIV RNA test performed at Week 24 but had a test result of HIV RNA <50 copies/mL at Week 12 and Week 36.||Participants|||Number
736705|NCT00443755|Other Pre-specified|Change From Baseline in Fat-Free Mass (FFM)|FFM was measured using dual energy x-ray absorptiometry (DEXA) scans and is reported in kilograms (kg).|Baseline, 3 months|Per-protocol analysis||kilograms||Standard Deviation|Mean
736706|NCT00443755|Other Pre-specified|Change From Baseline in Body Fat|Body fat is reported as a percentage of body weight.|Baseline, 3 months|Per-protocol population||percentage of body weight||Standard Deviation|Mean
736707|NCT00443755|Other Pre-specified|Change From Baseline in Body Mass Index|Body Mass Index (BMI) is a health index for comparing weight to height. BMI is a person's weight in kilograms (kg) divided by his or her height in meters squared. The body mass index is an indication if a person is at a suitable weight for his height on an approximation of body fat.|Baseline, 3 months|Per-protocol population||kg/m^2||Standard Deviation|Mean
736708|NCT00443755|Secondary|Change From Baseline in the Inflammatory Biomarker Adiponectin|Adiponectin is an anti-inflammatory cytokine and is reported in milligrams per milliliter (mg/mL).|Baseline, 3 months|Per-protocol analysis||mg/mL||Standard Deviation|Mean
736709|NCT00443755|Secondary|Change From Baseline in Inflammatory Biomarker Tumor Necrosis Factor-alpha (TNF-α)|TNF-α is an inflammatory cytokine and is reported in picograms/milliliter (pg/mL).|Baseline, 3 month|Per-protocol analysis||pg/mL||Standard Deviation|Mean
736710|NCT00443755|Secondary|Change From Baseline in the Inflammatory Biomarker C-Reactive Protein (CRP)|CRP is an inflammatory cytokine and is reported in milligrams per deciliter (mg/dL).|Baseline, 3 months|Per-protocol analysis||mg/dL||Standard Deviation|Mean
736711|NCT00443755|Secondary|Change From Baseline in the Inflammatory Biomarker Interleukin 6 (IL-6)|IL-6 is an inflammatory cytokine and reported in picograms per deciliter (pg/dL).|Baseline, 3 months|Per protocol analysis||pg/mL||Standard Deviation|Mean
736712|NCT00443755|Secondary|Change From Baseline in the Thrombotic Biomarker Plasminogen Activator Inhibitor-1 (PAI-1)|PAI-1 was measured by enzyme-linked immunosorbent assay (Diagnostica Stago Inc., Parsippany, New Jersey) and reported in nanograms per milliliter (ng/mL).|Baseline, 3 months|Per-protocol analysis||ng/mL||Standard Deviation|Mean
736713|NCT00443755|Secondary|Change From Baseline in the Thrombotic Biomarker Fibrinogen|Fibrinogen was measured by thrombin clotting rate assay (Beckman Coulter, Inc. Brea, California) and reported in milligrams/deciliter (mg/dL).|Baseline, 3 months|Per-protocol analysis||mg/dL||Standard Deviation|Mean
736714|NCT00443755|Secondary|Change From Baseline in Lipid Profile|Change in lipids were measured by the change from baseline to 3 months of triglycerides, high-density lipoprotein cholesterol (HDL-C) and non-high-density lipoprotein cholesterol (non-HDL-C). All were reported in milligrams/deciliter (mg/dL).|Baseline, 3 months|||mg/dL||Standard Deviation|Mean
736715|NCT00443755|Secondary|Change From Baseline in Insulin Levels|Insulin levels in the blood were measured by immunoenzymatic assay and reported in micro International Units per milliliter (mcIU/mL).|Baseline, 3 months|Per-protocol analysis||microIU/mL||Standard Deviation|Mean
736716|NCT00443755|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|HbA1c is a measure of average blood sugar levels over the preceding 3 month period. HbA1c was measured by ion-exchange chromatography and reported as a percentage.|Baseline, 3 months|Per-protocol analysis||percentage||Standard Deviation|Mean
736717|NCT00443755|Secondary|Change From Baseline in Fasting Blood Glucose Level|Glucose (sugar) was measured in the blood and reported in milligrams per deciliter (mg/dL).|Baseline, 3 months|Per-protocol analysis||mg/dL||Standard Deviation|Mean
736718|NCT00443755|Primary|Change From Baseline in Insulin Sensitivity as Measured by Glucose Infusion Rate (GIR)|Insulin sensitivity was measured the morning after an overnight fast during an in-patient stay in the Clinical Research Unit & was determined by the mean GIR necessary to maintain euglycemia during a hyperinsulinemic (1.5 mcIU/kg of FFM per minute)-euglycemic (85-95 mg/dL) clamp. The clamp is an 8 hour process where a hand vein is catheterized to collect blood samples and intravenous lines are used to infuse glucose, saline, insulin, phenylalanine and amino acid solutions at at pre-specified times/rates. The mean GIR was calculated as the rate per kilograms of fat-free mass (FFM) during 4 hours of steady-state (hours 4-8 of the 8 hour clamp) reported as micromols/kilogram of FFM per minute. The FFM was measured by dual-energy x-ray absorptiometry (DEXA) scan. Insulin was infused with 5% essential amino acid solution (3mL/kg of FFM/hour) to prevent the insulin-dependent decrease of amino acids during insulin infusion.|Baseline, 3 months|Per-protocol analysis||micromols/kg of FFM/minute||Standard Deviation|Mean
737282|NCT00448630|Primary|Metabolic Syndrome Parameter Fasting Blood Sugar|Iterative measurement of fasting blood sugar. Mean at time points.|Baseline, 1 Month, 4 Months|Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.||mg/dl (miligrams per deciliter)||Standard Deviation|Mean
736720|NCT00443820|Secondary|Safety and Tolerability Assessed by the Number of Participants With Adverse Events|Safety and tolerability data as assessed by the number of participants with Adverse Events (AE), Serious Adverse Events, Drug discontinuation due to an AE and death. Additional details can be found in the Adverse Event Section.|52 weeks|Safety Population||Number of participants|||Number
736721|NCT00443820|Secondary|Efficacy Assessed by the Percentage of Participants With Clinical Effectiveness at the End of Study After Treating Participants for 24 or 48 Weeks|"Clinical effectiveness is defined as negative KOH microscopy and negative culture for dermatophytes and <= 10% residual involvement of the target toenail.
Clinical effectiveness was a composite binary variable defined as
Yes” if:
If mycological cure (negative KOH and negative culture for dermatophytes) and
= 10% residual involvement of the target toenail
No” if otherwise"|52 weeks|Intent to treat (ITT) population, Last observation carried forward (LOCF)||Percentage of participants|||Number
736722|NCT00443820|Secondary|Efficacy Assessed by the Percentage of Participants With Mycological Cure at the End of Study After Treating Participants for 24 or 48 Weeks|Mycological cure is defined as negative KOH microscopy and negative culture for dermatophytes.|52 weeks|Intent to treat (ITT) population, Last observation carried forward (LOCF)||Percentage of participants|||Number
736723|NCT00443820|Primary|Efficacy Assessed by the Percentage of Participants With Complete Cure at the End of Study (Week 52) After Treating for 24 or 48 Weeks|Complete cure is defined as negative KOH microscopy and negative culture for dermatophytes and no residual involvement of the target toenail.|52 weeks|Intent to treat (ITT) population, Last observation carried forward (LOCF)||Percentage of participants|||Number
736724|NCT00430027|Primary|Overall Toxicity|The primary objective of this pilot study was to determine whether neoadjuvant capecitabine/oxaliplatin/cetuximab and external beam radiation therapy followed by surgical resection and then followed by post operative adjuvant capecitabine, oxaliplatin and cetuximab is feasible with acceptable toxicity profile.|Up to 4 weeks|The study was terminated, study end points were not reached.|||||
736725|NCT00430092|Primary|Anterior Chamber Cell Grade of “0” on Day 8 (Difluprednate QID vs Placebo).|Measured on a 0 to 4 scale: “0” is ≤ 1 cell; “1” is 2-10 cells; “2” is 11-20 cells; “3” is 21-50 cells; “4” is > 50 cells.|Day 8 (QID)|The ITT population was defined as all randomized subjects who received at least 1 administration of the study drug. Analysis of the ITT population, with LOCF for missing data, was conducted for all primary and secondary endpoints at Days 3, 8, 15, and 29.||participants|||Number
736726|NCT00430248|Secondary|Mean Percent Change From Baseline in Serum Urate Levels at Final Visit.|The percent change in serum urate from baseline to the Final visit was summarized. The final visit was the last visit at which a serum urate value was collected.|Baseline and Last Visit on treatment (up to 6 months)|Analysis was performed on the ITT subjects with a post-baseline serum urate value.||percent change from baseline||Standard Deviation|Mean
736727|NCT00430248|Secondary|Mean Percent Change From Baseline in Serum Urate Levels at Month 6 Visit.|Serum urate values were obtained at the Month 6 visit. The percent change in serum urate from baseline to the Month 6 visit was summarized.|Baseline and Month 6|Analysis was performed on the ITT subjects with a serum urate value at Month 6 visit.||percent change from baseline||Standard Deviation|Mean
736728|NCT00430248|Secondary|Mean Percent Change From Baseline in Serum Urate Levels at Month 4 Visit|Serum urate values were obtained at the Month 4 visit. The percent change in serum urate from baseline to the Month 4 visit was summarized.|Baseline and Month 4|Analysis was performed on the ITT subjects with a serum urate value at Month 4 visit.||percent change from baseline||Standard Deviation|Mean
736729|NCT00430248|Secondary|Mean Percent Change From Baseline in Serum Urate Levels at Month 2 Visit.|Serum urate values were obtained at the Month 2 visit. The percent change in serum urate from baseline to the Month 2 visit was summarized.|Baseline and Month 2|Analysis was performed on the ITT subjects with a serum urate value at Month 2 visit.||percent change from baseline||Standard Deviation|Mean
736730|NCT00430248|Secondary|Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Final Visit|The percentage of subjects whose serum urate level was <4.0 mg/dL at the Final Visit was summarized. The Final Visit was the last visit at which a serum urate values was collected.|Last Visit on treatment (up to 6 months)|Analysis was performed on the ITT subjects with a post-baseline serum urate value.||percentage of subjects|||Number
736731|NCT00430248|Secondary|Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Month 6 Visit|Serum urate values were obtained at the Month 6 visit. The percentage of subjects whose serum urate was <4.0 mg/dL at the Month 6 visit was summarized.|Month 6|Analysis was performed on the ITT subjects with a serum urate value at Month 6 visit.||percentage of subjects|||Number
736732|NCT00430248|Secondary|Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Month 4 Visit|Serum urate values were obtained at the Month 4 visit. The percentage of subjects whose serum urate was <4.0 mg/dL at the Month 4 visit was summarized.|Month 4|Analysis was performed on the ITT subjects with a serum urate value at Month 4 visit.||percentage of subjects|||Number
736733|NCT00430248|Secondary|Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Month 2 Visit|Serum urate values were obtained at the Month 2 visit. The percentage of subjects whose serum urate was <4.0 mg/dL at the Month 2 visit was summarized.|Month 2|Analysis was performed on the ITT subjects with a serum urate value at Month 2 visit.||percentage of subjects|||Number
737283|NCT00448630|Primary|Metabolic Syndrome Parameter Waist Circumference|Iterative measurement of waist circumference. Mean at timepoints.|Baseline, 1 Month, 4 Months|Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.||cm (centimeter)||Standard Deviation|Mean
736734|NCT00430248|Secondary|Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Final Visit.|The percentage of subjects whose serum urate level was <5.0 mg/dL at the Final Visit was summarized. The Final Visit was the last visit at which a serum urate values was collected.|Last Visit on treatment (up to 6 months)|Analysis was performed on the ITT subjects with a post-baseline serum urate value.||percentage of subjects|||Number
736735|NCT00430248|Secondary|Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 6 Visit.|Serum urate values were obtained at the Month 6 visit. The percentage of subjects whose serum urate was <5.0 mg/dL at the Month 6 visit was summarized.|Month 6|Analysis was performed on the ITT subjects with a serum urate value at Month 6 visit.||percentage of subjects|||Number
736736|NCT00430248|Secondary|Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 4 Visit.|Serum urate values were obtained at the Month 4 visit. The percentage of subjects whose serum urate was <5.0 mg/dL at the Month 4 visit was summarized.|Month 4|Analysis was performed on the ITT subjects with a serum urate value at Month 4 visit.||percentage of subjects|||Number
736737|NCT00430248|Secondary|Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 2 Visit.|Serum urate values were obtained at the Month 2 visit. The percentage of subjects whose serum urate was <5.0 mg/dL at the Month 2 visit was summarized.|Month 2|Analysis was performed on the ITT subjects with a serum urate value at Month 2 visit||percentage of subjects|||Number
736738|NCT00430248|Secondary|Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 6 Visit.|Serum urate values were obtained at the Month 6 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 6 visit was summarized.|Month 6|Analysis was performed on the ITT subjects with a serum urate value at Month 6 visit.||percentage of participants|||Number
736739|NCT00430248|Secondary|Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 4 Visit.|Serum urate values were obtained at the Month 4 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 4 visit was summarized.|Month 4|Analysis was performed on the ITT subjects with a serum urate value at Month 4 visit.||percentage of subjects|||Number
736740|NCT00430248|Secondary|Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 2 Visit.|Serum urate values were obtained at the Month 2 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 2 visit was summarized.|Month 2|Analysis was performed on the ITT subjects with a serum urate value at Month 2 visit.||percentage of subjects|||Number
736741|NCT00430248|Secondary|Percentage of Renal Impairment Subjects Whose Final Visit Serum Urate Level is <6.0 mg/dl|The percentage of subjects with mild-to-moderate renal impairment whose serum urate was <6.0 mg/dL at the final visit was summarized. The final visit was the last visit at which a serum urate value was collected.|Last Visit on treatment (up to 6 months)|Analysis was performed on the ITT subjects with mild-to-moderate renal impairment (estimated creatinine clearance of 30 mL/min to 89 mL/min), with a post-baseline serum urate level.||percentage of subjects|||Number
736742|NCT00430248|Primary|Percentage of Subjects Whose Serum Urate Level is <6.0 Milligrams Per Deciliter (mg/dL) at the Final Visit.|The percentage of subjects whose serum urate level was <6.0 mg/dL at the Final Visit was summarized. The Final Visit was the last visit at which a serum urate value was collected.|Last Visit on treatment (up to 6 months)|Analysis was performed on intent-to-treat (ITT) subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had baseline serum urate ≥8.0 mg/dL. A subject's baseline value was used in the primary analysis if no postbaseline serum urate level was obtained.||percentage of subjects|||Number
736743|NCT00430300|Other Pre-specified|Change in Post-Study Drug Forced Expiratory Volume in 1 Second (FEV1) Compared to Pre-Study Drug Forced Expiratory Volume in 1 Second (FEV1) at Week 0, 1, 2, 4, and 6|FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Post-study drug FEV1 was obtained from spirometry, performed 15-30 minutes after study treatment administration. Pre-study drug FEV1 was obtained from spirometry, performed before study treatment administration.|Pre-dose and 15 to 30 minutes Post-dose at Week 0, 1, 2, 4, 6|Data for this pre-specified endpoint was not analyzed, as the study was terminated due to futility based on results of interim analysis.|||||
736744|NCT00430300|Other Pre-specified|Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (Heart Rate) at Week 0, 1, 2, 4, 6, and 8|Standard 12-lead ECG was performed after the participant has rested quietly for at least 10 minutes in supine position. The time interval between consecutive heart beats (RR interval) was used to calculate heart rate.|Baseline (pre-dose at Week 0); Pre-dose and 3-hour post-dose on Week 6; 3-hour post-dose on Week 0, 1, 2, 4; Week 8 (follow-up)|Safety analysis set included all participants who received at least 1 dose of study treatment. Here “n” signifies participants who were evaluable for specified time-point for each arm group, respectively.||bpm||Standard Deviation|Mean
736745|NCT00430300|Other Pre-specified|Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8|Standard 12-lead ECG was performed after participant has rested for at least 10 minutes in supine position. ECG intervals (Int) included PR Int (time between onset of atrial depolarization and onset of ventricular depolarization), QRS Int (represented ventricular depolarization), RR Int (time between 2 QRS complex), QT Int (time corresponding to the beginning of depolarization to repolarization of the ventricles), corrected QT (QTc) Int, QT Int corrected by Fridericia’s formula (QTcF=QT divided by cube root of RR Int) and Bazett’s formula (QTcB=QT divided by square root of RR Int).|Baseline (pre-dose at Week 0); Pre-dose and 3-hour post-dose on Week 6; 3-hour post-dose on Week 0, 1, 2, 4; Week 8 (follow-up)|Safety analysis set included all participants who received at least 1 dose of study treatment. Here “n” signifies participants who were evaluable for specified time-point for each arm group, respectively.||milliseconds (msec)||Standard Deviation|Mean
736756|NCT00430300|Secondary|Change From Baseline in Post-Bronchodilator FEV6 at Week 6|FEV6 is the maximal volume of air exhaled in the first 6 seconds of a forced expiration from a position of full inspiration. Post-bronchodilator FEV6 was obtained from spirometry, performed 15-30 minutes after bronchodilator (salbutamol) administration.|15 to 30 minutes post-bronchodilator administration at Baseline, Week 6|Data for this pre-specified outcome was not analyzed, as the study was terminated due to futility based on results of interim analysis.|||||
737284|NCT00448630|Primary|Metabolic Syndrome Parameter Body Weight|Iterative measurement of body weight. Mean at time points.|Baseline, 1 Month, 4 Months|Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.||kg (kilogram)||Standard Deviation|Mean
736746|NCT00430300|Other Pre-specified|Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6|BP is the pressure of the blood within the arteries. It is produced primarily by the contraction of the heart muscle. BP measurement is recorded by 2 numbers: systolic BP (SBP, BP when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle) and diastolic BP (DBP, BP when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles). BP was measured by sphygmomanometer (manual or semi-automated) using appropriate-sized and calibrated cuff after participant rested in supine position for 5 minutes.|Baseline (pre-dose at Week 0); Pre-dose and 3-hour post-dose on Week 1, 6; 3-hour post-dose on Week 0, 2, 4|Safety analysis set included all participants who received at least 1 dose of study treatment. Here “n” signifies participants who were evaluable for specified time-point for each arm group, respectively.||millimeter of mercury (mmHg)||Standard Deviation|Mean
736747|NCT00430300|Other Pre-specified|Change From Baseline in Pulse Rate at Week 0, 1, 2, 4, and 6|Pulse rate: the number of pulsations noted in a peripheral artery per unit of time after participant rested supine for 5 minutes, reported as beats per minute (bpm).|Baseline (pre-dose at Week 0); Pre-dose and 3-hour post-dose on Week 1, 6; 3-hour post-dose on Week 0, 2, 4|Safety analysis set included all participants who received at least 1 dose of study treatment. Here “n” signifies participants who were evaluable for specified time-point for each arm group, respectively.||bpm||Standard Deviation|Mean
736748|NCT00430300|Secondary|Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C)|PGI-C: participant rated instrument to measure participant's clinical condition in terms of change relative to the start of treatment. Rated on a 7-point scale from 1 (very much improved) to 7 (very much worse). Higher score = more affected.|Week 6|FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.||participants|||Number
736749|NCT00430300|Secondary|Number of Participants With Categorical Scores on Clinical Global Impression of Change (CGI-C)|CGI-C: clinician’s global impression of a participant’s clinical condition in terms of change relative to the start of treatment. Rated on a 7-point scale from 1 (very much improved) to 7 (very much worse). Higher score = more affected.|Week 6|FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.||participants|||Number
736750|NCT00430300|Secondary|Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8|The PEFR is a participant’s maximum speed of expiration, as measured with a peak flow meter. All participants were issued with a hand-held peak flow device and instructed to perform twice daily (morning and evening) prior to taking any medication. A participant’s daily values were averaged over each week.|Pre-dose at Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8|FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. Here ‘n’ signifies participants who were evaluable for this measure at specified time-point for each arm, respectively.||liter per minute||Standard Deviation|Mean
736751|NCT00430300|Secondary|Change From Baseline in Rescue Bronchodilator Use at Week 1, 2, 3, 4, 5, 6, 7, and 8|Participants were issued with rescue medication (Salbutamol MDI [100 mcg/actuation]) and were instructed to use 1-2 puffs as required, as a rescue therapy. All rescue medication use was recorded in daily paper dairy by participant. A participant’s daily use (puffs/day) was averaged over each week.|Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8|FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable for this measure at specified time-point for each arm, respectively.||puffs/day||Standard Deviation|Mean
736752|NCT00430300|Secondary|Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8|COPD symptom score: participants rated the severity of their COPD symptoms (cough, breathlessness, and sputum production) in daily symptom dairy according to how they felt during the past 24 hours on a 4-point scale ranging from 0 (none) to 3 (severe). A participant’s daily score for each symptom was averaged over each week.|Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8|FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable for this measure at specified time-point for each arm, respectively.||units on a scale||Standard Deviation|Mean
736753|NCT00430300|Secondary|Change From Baseline in Dyspnea (Baseline Dyspnea Index/Transition Dyspnea Index [BDI/TDI]) at Week 2, 4, and 6|BDI: 24-item questionnaire to assess baseline dyspnea in 3 domains, functional impairment; magnitude of task; magnitude of effort. Each item rated on 5-point scale: 0 (very severe), 4 (no impairment). BDI total score range: 0 to 12, lower score=more severe dyspnea. TDI: 24-item questionnaire to measure changes in dyspnea severity from baseline in same 3 domains, as in BDI. Each item rated on 7-point scale: -3 (major deterioration) to 3 (major improvement). TDI total score range: -9 to 9, lower score=more deterioration. BDI/TDI total scores were obtained by adding scores for each of 3 domains.|Baseline, Week 2, 4, 6|FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. Here ‘n’ signifies participants who were evaluable for this measure at specified time-point for each arm, respectively.||units on a scale||Standard Deviation|Mean
736754|NCT00430300|Secondary|Change From Baseline in Post-Bronchodilator IC at Week 6|IC is the maximum volume of air that can be inhaled into the lungs from the normal resting position after breathing out normally. Post-bronchodilator IC was obtained from spirometry, performed 15-30 minutes after bronchodilator (salbutamol) administration.|15 to 30 minutes post-bronchodilator administration at Baseline, Week 6|Data for this pre-specified outcome was not analyzed, as the study was terminated due to futility based on results of interim analysis.|||||
736755|NCT00430300|Secondary|Change From Baseline in Post-Bronchodilator FVC at Week 6|FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Post-bronchodilator FVC was obtained from spirometry, performed 15-30 minutes after bronchodilator (salbutamol) administration.|15 to 30 minutes post-bronchodilator administration at Baseline, Week 6|Data for this pre-specified outcome was not analyzed, as the study was terminated due to futility based on results of interim analysis.|||||
736757|NCT00430300|Secondary|Change From Baseline in Post-Bronchodilator FEV1 at Week 6|FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Post-bronchodilator FEV1 was obtained from spirometry, performed 15-30 minutes after bronchodilator (salbutamol) administration.|15 to 30 minutes post-bronchodilator administration at Baseline, Week 6|FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. Here ‘N’(number of participants analyzed) signifies participants who were evaluable for this measure.||liter||Standard Deviation|Mean
736758|NCT00430300|Secondary|Change From Baseline in Post-Study Drug IC at Week 2, 4, and 6|IC is the maximum amount of air that can be inhaled into the lungs from the normal resting position after breathing out normally. Post-study drug IC was obtained from spirometry, performed 15-30 minutes after study treatment administration.|15 to 30 minutes post-dose at Baseline, Week 2, 4, 6|Data for this pre-specified outcome was not analyzed, as the study was terminated due to futility based on results of interim analysis.|||||
736759|NCT00430300|Secondary|Change From Baseline in Post-Study Drug FVC at Week 2, 4, and 6|FVC is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Post-study drug FVC was obtained from spirometry, performed 15-30 minutes after study treatment administration.|15 to 30 minutes post-dose at Baseline, Week 2, 4, 6|Data for this pre-specified outcome was not analyzed, as the study was terminated due to futility based on results of interim analysis.|||||
736760|NCT00430300|Secondary|Change From Baseline in Post-Study Drug FEV6 at Week 2, 4, and 6|FEV6 is the maximal volume of air exhaled in the first 6 seconds of a forced expiration from a position of full inspiration. Post-study drug FEV6 was obtained from spirometry, performed 15-30 minutes after study treatment administration.|15 to 30 minutes post-dose at Baseline, Week 2, 4, 6|Data for this pre-specified outcome was not analyzed, as the study was terminated due to futility based on results of interim analysis.|||||
736761|NCT00430300|Secondary|Change From Baseline in Post-Study Drug FEV1 at Week 2, 4, and 6|FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Post-study drug FEV1 was obtained from spirometry, performed 15-30 minutes after study treatment administration.|15 to 30 minutes post-dose at Baseline, Week 2, 4, 6|FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. Here ‘n’ signifies participants who were evaluable for this measure at specified time-point for each arm, respectively.||liter||Standard Deviation|Mean
736762|NCT00430300|Secondary|Change From Baseline in Trough Inspiratory Capacity (IC) at Week 2, 4, 6 and 8|IC is the maximum volume of air that can be inhaled into the lungs from the normal resting position after breathing out normally. Trough IC was obtained from spirometry, performed before study treatment administration.|Pre-dose at Baseline, Week 2, 4, 6, 8|FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. Here ‘n’ signifies participants who were evaluable for this measure at specified time-point for each arm, respectively.||liter||Standard Deviation|Mean
736763|NCT00430300|Secondary|Change From Baseline in Trough Forced Vital Capacity (FVC) at Week 2, 4, 6 and 8|FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Trough FVC was obtained from spirometry, performed before study treatment administration.|Pre-dose at Baseline, Week 2, 4, 6, 8|FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. Here ‘n’ signifies participants who were evaluable for this measure at specified time-point for each arm, respectively.||liter||Standard Deviation|Mean
736764|NCT00430300|Secondary|Change From Baseline in Trough Forced Expiratory Volume in 6 Seconds (FEV6) at Week 2, 4, 6 and 8|FEV6 is the maximal volume of air exhaled in the first 6 seconds of a forced expiration from a position of full inspiration. Trough FEV6 was obtained from spirometry, performed before study treatment administration.|Pre-dose at Baseline, Week 2, 4, 6, 8|FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. Here ‘n’ signifies participants who were evaluable for this measure at specified time-point for each arm, respectively.||liter||Standard Deviation|Mean
736765|NCT00430300|Secondary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 2, 4 and 8|FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Trough FEV1 was obtained from spirometry, performed before study treatment administration.|Pre-dose at Baseline, Week 2, 4, 8|FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. Here ‘n’ signifies participants who were evaluable for this measure at specified time-point for each arm, respectively.||liter||Standard Deviation|Mean
736766|NCT00430300|Primary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 6|FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Trough FEV1 was obtained from spirometry, performed before study treatment administration.|Pre-dose at Baseline, Week 6|Full analysis set (FAS): all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. Missing data were imputed using Last Observation Carried Forward (LOCF). Here ‘n’ signifies participants who were evaluable for this measure at specified time-point for each arm, respectively.||liter||Standard Deviation|Mean
736767|NCT00430352|Secondary|Percentage of Participants With PR Who Converted to CRu|Percentage of participants with PR or CR(u) conversion while on rituximab maintenance therapy over a study period of 2 years with 1 year of follow-up. For each participant, the last response to induction therapy immediately prior to study entry was compared to the best response observed during rituximab maintenance therapy. Assessment and definition of response was based on the International Workshop to Standardize Response Criteria for NHL.|Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose|ITT population; only participants with PR to most recent treatment were included in the analysis.||percentage of participants||95% Confidence Interval|Number
736792|NCT00430508|Secondary|Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 12.|Change = Week 12 - Week 8 (baseline).|4 weeks, change = week 12 - week 8|Full Analysis Set-Last Observation Carried Forward||mm Hg||Standard Deviation|Mean
736793|NCT00430508|Primary|Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 16|Change = Week 16 - Week 8 (baseline).|8 weeks, change = week 16 - week 8|Full Analysis Set-Last Observation Carried Forward.||mm Hg||Standard Deviation|Mean
736768|NCT00430352|Secondary|Percentage of Participants With Response by Best Response to Study Treatment|Percentage of participants with complete response (CR), unconfirmed CR (CRu), no change, or progressive disease (PD). For each participant, the last response to induction therapy immediately prior to study entry was compared to the best response observed during rituximab maintenance therapy. Where possible, assessment of response was based on the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma (NHL).|Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose|ITT population; only participants who received any study treatment were included in the analysis.||percentage of participants|||Number
736769|NCT00430352|Secondary|Time to NLT - Time to Event|TNLT was measured from the date of first rituximab maintenance infusion to the date of first documented intake of any new anti-lymphoma treatment (chemotherapy, radiotherapy, immunotherapy, etc). Participants who did not have documentation that an NLT had started and participants who were lost to follow up were censored at their last visit where the assessment for start of any new lymphoma medication was actually made.|Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose|ITT population||months||95% Confidence Interval|Median
736770|NCT00430352|Secondary|Time to Next Lymphoma Treatment (NLT) - Percentage of Participants With an Event|As a measure of time to NLT (TNLT), the percentage of participants with new lymphoma treatment over a study period of 2 years with 1 year of follow-up. TNLT was measured from the date of first rituximab maintenance infusion to the date of first documented intake of any new anti-lymphoma treatment (chemotherapy, radiotherapy, immunotherapy, etc). Participants who did not have documentation that an NLT had started and participants who were lost to follow up were censored at their last visit where the assessment for start of any new lymphoma medication was actually made.|Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose|ITT population||percentage of participants|||Number
736771|NCT00430352|Secondary|Overall Survival (OS) - Time to Event|OS was determined from the day of first rituximab maintenance infusion until the date of death irrespective of cause. Participants who had not died at the time of end of the whole study and participants who were lost to follow up were censored at the date of the last contact.|Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose|ITT population||percentage of participants||95% Confidence Interval|Median
736772|NCT00430352|Secondary|Overall Survival (OS) - Percentage of Participants With an Event|As a measure of overall survival (OS), the percentage of participants who died over the study period of 2 years with 1 year of follow-up. OS was determined from the day of first rituximab maintenance infusion until the date of death irrespective of cause. Participants who had not died at the time of end of the whole study and participants who were lost to follow up were censored at the date of the last contact.|Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose|ITT population||percentage of participants|||Number
736773|NCT00430352|Secondary|Event-Free Survival (EFS) - Time to Event|EFS was measured from the day of first rituximab maintenance infusion until the date of first documented disease progression, death by any cause, or the institution of new anti-lymphoma treatment. Participants who experienced none of these events at the end of the study and participants who were lost to follow-up were censored at their last clinical assessment date.|Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose|ITT population||months||95% Confidence Interval|Median
736774|NCT00430352|Secondary|Event-Free Survival (EFS) - Percentage of Participants With an Event|The percentage of participants who experienced PD or death or required a next or new lymphoma treatment over a study period of 2 years with 1 year of follow-up. EFS was measured from the day of first rituximab maintenance infusion until the date of first documented disease progression, death by any cause, or the institution of new anti-lymphoma treatment. Participants who experienced none of these events at the end of the study and participants who were lost to follow-up were censored at their last clinical assessment date.|Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose|ITT population||percentage of participants|||Number
736775|NCT00430352|Secondary|Progression-Free Survival - Time to Event|PFS was measured from the day of first rituximab maintenance infusion until the date of first documented disease progression or death by any cause. Participants who experienced none of these events at the time of analysis (clinical cutoff) and participants who were lost to follow-up were censored at their last clinical assessment date.|Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose|ITT population||months||95% Confidence Interval|Median
736776|NCT00430352|Secondary|Progression-Free Survival - Percentage of Participants With an Event|PFS was measured from the day of first rituximab maintenance infusion until the date of first documented disease progression or death by any cause. Participants who experienced none of these events at the time of analysis (clinical cutoff) and participants who were lost to follow-up were censored at their last clinical assessment date.|Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose|ITT population||percentage of participants|||Number
736777|NCT00430352|Primary|Percentage of Participants With an Adverse Event (AE) - Overall Summary|Data presented include percentage of participants with any AE, any infusion-related AE, any serious adverse event (SAE), any infusion-related SAE (counted separately from SAEs), death, and participants with toxicity as the primary cause for treatment discontinuation.|24 months|Safety Population: any participant who received at least 1 dose of study treatment.||percentage of participants|||Number
736778|NCT00430495|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. An SAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.|Baseline up to Week 38|Safety population included all randomized participants who received at least 1 treatment dose and had safety data following their first dose.||participants|||Number
736794|NCT00430625|Secondary|Percent Change From Baseline to 12 Months in Chemokine (C-C Motif) Ligand 18 (CCL18)||Week 53|12 patients in the 60 U/kg group and 13 patients in the 45 U/kg group were analyzed.||Percent|||Number
736795|NCT00430625|Secondary|Percent Change From Baseline to 12 Months in Plasma Chitotriosidase for Each Treatment Group|Percent Change from Baseline to Weeks 53 by Randomized velaglucerase alfa Treatment Group - Subset of intent to treat (ITT) Population who were wild type homozygous for chitotriosidase.|Week 53|2 patients in the 60 U/kg group and 7 patients in the 45 U/kg group who were wild type for the chitotriosidase mutation were analyzed; remaining patients were deficient in chitotriosidase activity.||Percent|||Number
736779|NCT00430495|Secondary|Percentage of Participants With Good or Moderate European League Against Rheumatism (EULAR) Response at Week 26|"The EULAR response criteria evaluate change in DAS28 scores represented as good response, moderate response, or no response considering both the current DAS28 score and the observed improvement from baseline. Participants were considered to have good or moderate EULAR response if at the time of assessment, their DAS28 score was <=5.1 and the improvement from baseline in their DAS28 score was greater than (>) 0.6; or if at the time of assessment, their DAS28 score was >5.1 and improvement from baseline in their DAS28 score was >1.2."|Week 26|ITT population included all randomized participants who received at least 1 treatment dose.||percentage of participants|||Number
736780|NCT00430495|Secondary|Percentage of Participants Achieving Improvement in Health Assessment Questionnaire Disability Index (HAQ-DI) of at Least 0.3 From Baseline at Week 26|The HAQ-DI is a participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item was scored on 4-point scale from 0 to 3: 0 = no difficulty; 1 = some difficulty; 2 = much difficulty; 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range is 0 to 3 where 0 = least difficulty and 3 = extreme difficulty. Percentage of participants achieving improvement in HAQ-DI of at least 0.3 from baseline at Week 26 was reported.|Week 26|ITT population included all randomized participants who received at least 1 treatment dose. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||percentage of participants|||Number
736781|NCT00430495|Secondary|Percentage of Participants Achieving Disease Activity Score in 28 Joints (DAS28) Based on CRP (DAS28-CRP) of <=2.6 at Week 26|DAS28-CRP incorporates non-graded joint counts for tenderness and swelling based on a total of 28 joints, CRP as a marker of inflammation, and a general health assessment using a 100 mm visual analog scale (the participant's global assessment of disease activity). DAS28 ranges between 0 and 10 representing current disease activity. A value above 5.1 represents high disease activity, a value below 3.2 represents low disease activity, and a value below 2.6 represents remission.|Week 26|ITT population included all randomized participants who received at least 1 treatment dose.||percentage of participants|||Number
736782|NCT00430495|Secondary|Percentage of Participants Achieving Disease Activity Score in 28 Joints (DAS28) Based on CRP (DAS28-CRP) of Less Than or Equal to (<=) 3.2 at Week 26|DAS28-CRP incorporates non-graded joint counts for tenderness and swelling based on a total of 28 joints, CRP as a marker of inflammation, and a general health assessment using a 100-millimeter (mm) visual analog scale (the participant's global assessment of disease activity). DAS28 ranges between 0 and 10 representing current disease activity. A value above 5.1 represents high disease activity, a value below 3.2 represents low disease activity, and a value below 2.6 represents remission.|Week 26|ITT population included all randomized participants who received at least 1 treatment dose.||percentage of participants|||Number
736783|NCT00430495|Secondary|Percentage of Participants Achieving American College of Rheumatology 70 Response Based on CRP (ACR70-CRP) at Week 26|ACR70-CRP response is defined as >=70% improvement in both tender joint counts (based on a total of 68 joints) and swollen joint counts (based on a total of 66 joints) together with >=70% improvement in at least 3 of the following 5 measures: 1) participant's assessment of pain; 2) participant's global assessment of disease activity; 3) physician's global assessment of disease activity; 4) participant's assessment of physical function; and 5) acute-phase marker (CRP).|Week 26|ITT population included all randomized participants who received at least 1 treatment dose.||percentage of participants|||Number
736784|NCT00430495|Secondary|Percentage of Participants Achieving American College of Rheumatology 50 Response Based on CRP (ACR50-CRP) at Week 26|ACR50-CRP response is defined as >=50% improvement in both tender joint counts (based on a total of 68 joints) and swollen joint counts (based on a total of 66 joints) together with >=50% improvement in at least 3 of the following 5 measures: 1) participant's assessment of pain; 2) participant's global assessment of disease activity; 3) physician's global assessment of disease activity; 4) participant's assessment of physical function; and 5) acute-phase marker (CRP).|Week 26|ITT population included all randomized participants who received at least 1 treatment dose.||percentage of participants|||Number
736785|NCT00430495|Primary|Percentage of Participants Achieving American College of Rheumatology 20 Response Based on C-reactive Protein (ACR20-CRP) at Week 26|ACR20-CRP response is defined as greater than or equal to (>=) 20 percent (%) improvement in both tender joint counts (based on a total of 68 joints) and swollen joint counts (based on a total of 66 joints) together with >=20% improvement in at least 3 of the following 5 measures: 1) participant's assessment of pain; 2) participant's global assessment of disease activity; 3) physician's global assessment of disease activity; 4) participant's assessment of physical function; and 5) acute-phase marker (CRP).|Week 26|ITT population included all randomized participants who received at least 1 treatment dose.||percentage of participants|||Number
736786|NCT00430508|Secondary|Change in Mean Night-time Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16.|Change = Week 16 - Week 8 (baseline).|8 weeks, change = week 16 - week 8|Full Analysis Set-Observed Cases||mm Hg||Standard Deviation|Mean
736787|NCT00430508|Secondary|Change in Mean Daytime Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16.|Change = Week 16 - Week 8 (baseline).|8 weeks, change = week 16 - week 8|Full Analysis Set-Observed Cases||mm Hg||Standard Deviation|Mean
736788|NCT00430508|Secondary|Change in Mean 24-hour Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16.|Change = Week 16 - Week 8 (baseline).|8 weeks, change = week 16 - week 8|Full Analysis Set-Observed Cases||mm Hg||Standard Deviation|Mean
736789|NCT00430508|Secondary|Number of Patients Achieving Target Blood Pressure at Week 16|Target Blood Pressure is diastolic blood pressure (dBP) < 90 mmHg and systolic blood pressure (sBP) < 140 mmHg for non-diabetics, and dBP < 80 mmHg and sBP < 130 mmHg for diabetics|8 weeks|Full Analysis Set-Last Observation Carried Forward||participants|||Number
736790|NCT00430508|Secondary|Change in Mean Trough Sitting Systolic Blood Pressure From Week 8(Baseline) to Week 12.|Change = Week 12 - Week 8 (baseline).|4 weeks, change = week 12 - week 8|Full Analysis Set-Last Observation Carried Forward||mm Hg||Standard Deviation|Mean
736791|NCT00430508|Secondary|Change in Mean Trough Sitting Systolic Blood Pressure From Week 8(Baseline) to Week 16.|Change = Week 16 - Week 8 (baseline).|8 weeks, change = week 16 - week 8|Full Analysis Set-Last Observation Carried Forward.||mm Hg||Standard Deviation|Mean
736796|NCT00430625|Secondary|Change From Baseline to 12 Months in Normalized Spleen Volume (Percent Body Weight) for Each Treatment Group (Measured by Magnetic Resonance Imaging (MRI))|12 patients in the 60 U/kg group and 13 patients in the 45 U/kg group were analyzed for efficacy in the intent to treat (ITT) population. Spleen Volume has been normalized for percent of body weight for each treatment arm. Spleen size relative to body weight = (Spleen volume [cc]/Body weight [kg])*100|Week 51|12 patients in the 60 U/kg group and 13 patients in the 45 U/kg group were analyzed for efficacy in the intent to treat (ITT) population.||Percent body weight||95% Confidence Interval|Mean
736797|NCT00430625|Secondary|Change From Baseline to 12 Months in Normalized Liver Volume (Percent Body Weight) for Each Treatment Group (Measured by Magnetic Resonance Imaging (MRI)|Liver Volume has been normalized for percentage of body weight for each treatment arm. Liver size relative to body weight = (Liver volume [cc]/Body weight [kg])*100|Week 51|12 patients in the 60 U/kg group and 13 patients in the 45 U/kg group were analyzed for efficacy in the intent to treat (ITT) population.||Percent body weight||95% Confidence Interval|Mean
736798|NCT00430625|Secondary|Change From Baseline to 12 Months in Platelet Counts for Each Treatment Group.|intent to treat (ITT) Population|Week 53|12 patients in the 60 U/kg group and 13 patients in the 45 U/kg group were analyzed for efficacy in the intent to treat (ITT) population.||x10^9/L||95% Confidence Interval|Mean
736799|NCT00430625|Secondary|Change From Baseline to 12 Months in Hemoglobin Concentration in 45 U/kg Treatment Group||Week 53|13 patients in the 45 U/kg group were analyzed for efficacy in the intent to treat (ITT) population.||(g/dL)||95% Confidence Interval|Mean
736800|NCT00430625|Primary|Change From Baseline to 12 Months in Hemoglobin Concentration for the 60 U/kg Treatment Group.|Efficacy endpoint|Week 53|12 patients in the 60 U/kg group were analyzed for efficacy in the intent to treat (ITT) population.||g/dL||95% Confidence Interval|Mean
736801|NCT00430638|Secondary|The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Stage 2 Hypertensives||Baseline to 12 months|146 Stage 2 hypertensive participants from both the olmesartan and placebo groups||mm Hg||Standard Deviation|Least Squares Mean
736802|NCT00430638|Secondary|The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Stage 1 Hypertensives||Baseline to 12 weeks|130 Stage 1 hypertensive participants from both the olmesartan and placebo groups.||mm Hg||Standard Deviation|Least Squares Mean
736803|NCT00430638|Secondary|The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Non-Black Participants.||Baseline to 12 weeks|221 non-Black participants from both the olmesartan and placebo groups were analyzed.||mm Hg||Standard Deviation|Least Squares Mean
736804|NCT00430638|Secondary|The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Black Participants.||Baseline to week 12|55 Black participants from both the olmesartan and placebo groups were analyzed.||mm Hg||Standard Deviation|Least Squares Mean
736805|NCT00430638|Secondary|The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Participants Greater Than or Equal to 65 Years Old.||Baseline to 12 weeks|44 participants of greater than 65 years of age, from both the olmesartan and placebo groups were analyzed.||mm Hg||Standard Deviation|Least Squares Mean
736806|NCT00430638|Secondary|The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Participants Less Than 65 Years Old.||Baseline to 12 weeks|232 participants from both the olmesartan and placebo groups, less than 65 years of age, were analyzed.||mm Hg||Standard Deviation|Least Squares Mean
736807|NCT00430638|Secondary|The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Females.|The difference in the change from baseline to week 12 in seated blood pressure for females in the olmesartan group vs. the placebo group was analyzed.|Baseline to week 12|145 female participants from both the olmesartan and placebo groups were analyzed.||mm Hg||Standard Deviation|Least Squares Mean
736808|NCT00430638|Secondary|The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Males.|The difference in the change from baseline to week 12 in seated systolic and diastolic blood pressure for males in the olmesartan group vs. the placebo group was analyzed.|Baseline to week 12|131 male participants||mm Hg||Standard Error|Least Squares Mean
736809|NCT00430638|Secondary|Change From Baseline in Mean Diastolic Blood Pressure (DBP) After 12 Weeks of Randomized Treatment as Measured by Omron Device.|Change from study baseline (average of triplicate DBP measurements at the last 2 qualifying visits during placebo run-in period) in DBP to the end of 12 weeks of randomized treatment using a last observation carried forward (LOCF) approach.|baseline to 12 weeks|The efficacy cohort is defined as any subject who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline efficacy blood pressure assessment. 140 participants were originally randomized to the olmesartan group, but two were erroneously started with the 40mg dose. 139 is the correct number analyzed.||mm Hg||Standard Error|Least Squares Mean
736810|NCT00430638|Primary|Change From Baseline in Mean Systolic Blood Pressure (SBP) After 12 Weeks of Randomized Treatment as Measured by Omron Device.|The change from baseline in mean systolic blood pressure (SBP) after 12 weeks of randomized treatment was compared between the olmesartan based treatment group and the placebo treatment group.|baseline to 12 weeks|The efficacy cohort is defined as any subject who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline efficacy blood pressure assessment. 140 participants were originally randomized to the olmesartan group. 139 is the correct number analyzed. For the placebo group the efficacy cohort = 137.||mm Hg||Standard Error|Least Squares Mean
736854|NCT00430716|Secondary|Change From Baseline in TAPSE Measurement at Week 12|TAPSE was measured as the total displacement of the tricuspid annulus in cm from end diastole to end systole.TAPSE is an indicator of progression of PAH / RV dysfunction.|Baseline and Week 12|ITT population included all participants who were randomized to study treatment and received at least 1 dose of study medication. If participant had missing value at any visit, LOCF method of imputation was used.||cm||95% Confidence Interval|Mean
736811|NCT00430677|Secondary|Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period (Continued)|preRX=pretreatment. Protein, urine: If missing preRX, use >=2, or if value >=4, or if preRX =0 or 0.5, use >=2, or if preRX=1, use >=3, or if preRX=2 OR 3 then use >=4. Glucose, urine: If missing preRX, use >=2, or if value >=4, or if preRX=0 or 0.5, use >=2, or if preRX=1, use >=3, or if preRX=2 or 3, use >=4. Blood, urine: If missing preRX, use >=2, or if value >=4, or if preRX =0 or 0.5, use >=2, or if preRX=1, use >=3, or if preRX=2 or 3, use >=4. Leukocyte esterase, urine: If missing preRX, use >=2, or if value >=4, or if preRX=0 or 0.5, use >=2, or if preRX=1, use >=3, or if preRX=2 or 3, use >=4.|From start of study drug on Day 365 to up to 56 days after last dose in the long-term extension period|All participants who entered and received at least 1 dose of study medication during the long-term extension period||Participants|||Number
736812|NCT00430677|Secondary|Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period (Continued)|LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Sodium, serum (mEq/L): <0.95*LLN or >1.05*ULN, or if preRX<LLN, use <0.95*preRX or >ULN if preRX>ULN, use >1.05*preRX or <LLN. Potassium, serum (mEq/L): <0.9* LLN or >1.1*ULN, or if preRX <LLN, use <0.9*preRX or >ULN if preRX>ULN, use >1.1*preRX or <LLN. Chloride, serum (mEq/L): <0.9*LLN or >1.1*ULN, or if preRX<LLN, use <0.9*preRX or >ULN. Calcium, total (mg/dL): <0.8*LLN or >1.2*ULN, or if preRX<LLN, use <0.75*preRX or >ULN if preRX>ULN, use >1.25*preRX or <LLN. Glucose, serum (mg/dL): <65 mg/dL, or >220 mg/dL. Glucose, fasting serum (mg/dL): <0.8*LLN or >1.5*ULN, or if preRX <LLN, use <0.8*preRX or >ULN if preRX>ULN, use >2.0*preRX or <LLN. Albumin (g/dL): <0.9*LLN, or if preRX <LLN, use <0.75*preRX. Cholesterol, total (mg/dL): >2*preRX. Triglycerides (mg/dL): >=2.5*ULN, or if preRX>ULN, use >=2.5*preRX. Triglycerides, fasting (mg/dL): >=2*ULN, or if preRX>ULN, use >2.0*preRX.|From start of study drug on Day 365 up to 56 days after last dose in the long-term extension period|All participants who entered and received at least 1 dose of study medication during the long-term extension period||Participants|||Number
736813|NCT00430677|Secondary|Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period|preRX=pretreatment; LLN=lower limit of normal; ULN=upper limit of normal. Hemoglobin (g/dL): >3g/dL decrease from preRX value. Hematocrit(%): <0.75*preRX. Erythrocytes (*10^6 c/uL): <0.75*preRX. Platelet count (*10^9 c/L): <0.67*LLN, or >1.5*ULN, or if preRX <LLN, use <0.5*preRX and <100,000/mm^3. Leukocytes (*10^3 c/uL): <0.75*LLN or >1.25*ULN, or if preRX <LLN, use <0.8* preRX or >ULN; if preRX>ULN, use >1.2*preRX or <LLN. Neutrophils + Bands (absolute) (*10^3 c/uL): If value <1.0*10^3 or if value >7.50*10^3 c/uL. Monocytes (absolute) (*10^3 c/uL): If value >2000/mm^3. Basophils (absolute)(*10^3 c/uL): If value >.750*10^3 c/uL. Eosinophils (absolute) (*10^3 c/uL): If value >.750*10^3 c/uL. ALP (U/L): >2*ULN, or if preRX>ULN, use >3* preRX. AST (U/L): >3*ULN, or if preRX>ULN, use >4*preRX. ALT (U/L): >3*ULN, or if preRX>ULN, use >4*preRX. GGT (U/L):>2*ULN, or if preRX >ULN, use >3*preRX. Bilirubin, total (mg/dL): >2*ULN, or if preRX>ULN, use >4*preRX. BUN (mg/dL): >1.5*preRX.|From start of study drug on Day 365 up to 56 days after last dose in the long-term extension period|All participants who entered and received at least 1 dose of study medication during the long-term extension period||Participants|||Number
736814|NCT00430677|Secondary|Number of Participants Achieving Renal Response|Renal response=serum creatinine level ≤25% above baseline value and greater than or equal to 50% improvement in the urine protein/creatinine ratio with 1 of the following: urine protein/creatinine ratio (UPCR) <113 mg/mmol, if the baseline ratio was <= 339 mg/mmol OR UPCR <339 mg/mmol,if the baseline ratio >339 mg/mmol.|At Day 365 (end of short-term period) and Day 645|All randomized participants who received treatment.||participants|||Number
736815|NCT00430677|Secondary|Number of Participants With a Treatment-emergent Seropositive Result During the Long-term Extension Period|Collected in at least 1 sample. Assessment includes immunogenicity (detection of serum antibodies which bind to CTLA4-Ig in the in vitro assays) and exposure to corticosteroids|Day 365 to end of long-term extension period|Immunogenicity analysis population consisted of participants who received at least 1 dose of abatacept and had at least 1 immunogenicity result available.||Participants|||Number
736816|NCT00430677|Secondary|Number of Participants With Death, Serious Adverse Events (SAE), Treatment-related Adverse Events SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs During Long-term Extension Period|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=possibly, probably, or certainly related to and of unknown relationship to study drug.|From start of study drug in long-term period (Day 365) to up to 56 days after the last dose of the long-term extension (LTE). Deaths in LTE reported to >56 days post last dose.|All participants who entered and received at least 1 dose of study medication during the long-term extension period||Participants|||Number
736817|NCT00430677|Secondary|Mean Change From Baseline in SLICC/ACR Damage Index|SLICC=Systemic Lupus International Collaborating Clinics; ACR=American College of Rheumatology. The SLICC/ACR Damage Index measures organ damage (nonreversible change, unrelated to active inflammation) occurring since onset of lupus, ascertained by clinical assessment and present for at least 6 months unless otherwise stated. The index assesses 47 items in 12 systems: Ocular, Neuropsychiatric, Renal, Pulmonary, Cardiovascular, Gastrointestinal, Peripheral Vascular, Musculoskeletal, Skin, Premature Gonadal Failure, Diabetes, Malignancy. Scores range from 0 to 2, and the same lesion cannot be scored twice. If damage is noted for a particular item, it is scored 1. No damage is scored 0. Some items may score 2 points if they occur more than once, so that the maximum possible score is 47. Scores can only increase with time, but scores rarely reach over 12. It is usually completed (or updated) yearly.|Day 365 to termination of the long-term extension phase|All randomized participants who received treatment. Treated participants with both post-baseline and baseline measurements showing non-reversible changes in the SLICC/ACR Damage Index (i.e, Change from baseline greater than or equal to 0). 99, 99 and 100 participants were treated respectively. Refer to outcome measure 11 for baseline values||Units on a scale||Standard Error|Mean
736855|NCT00430716|Secondary|Change From Baseline in Pro-BNP at Week 12|Pro- BNP which is a precursor of BNP, is a non-invasive biomarker and an indicator of progression of PAH / RV dysfunction in participants with PAH.|Baseline and Week 12|ITT population included all participants who were randomized to study treatment and received at least 1 dose of study medication. If participant had missing value at any visit, LOCF method of imputation was used.||pg/mL||95% Confidence Interval|Mean
736818|NCT00430677|Secondary|Number of Participants Achieving Patient Response of Complete or Partial Response, Based on the June 2010 Food and Drug Administration Guidance Document for Lupus Nephritis|Patient response=complete, partial, or no response. Complete response=serum creatinine (SCr) normal, inactive urinary sediment, no cellular casts, urinary protein/creatinine (UPCR) ratio<56.5 mg/mmol. Partial response=SCr normal or ≤25% above baseline value, RBCs at reference range, UPCR <56.5 mg/mmoL OR ≥50% improvement in UPCR with one of the following: UPCR <113 or <339 mg/mmoL, based on the baseline ratio. No response=Not achieving complete or partial response criteria.|At Day 365 (end of Short-term Period) and Day 645|All participants who entered and received at least 1 dose of study medication during the long-term extension period||Participants|||Number
736819|NCT00430677|Secondary|Number of Participants Achieving Complete Response by ACCESS Definition|The Abatacept and Cyclophosphamide Combination Efficacy and Safety Study (ACCESS) defines complete response as a response meeting all of the following criteria: serum creatinine ≤upper limit of normal as defined by the central laboratory or ≤125% of the higher value at either screening or baseline; urine protein/creatinine ratio <50 mg/mmoL; and prednisone or prednisone-equivalent dose tapered to 10 mg per day.|End of short-term period (Day 365) to termination of the long-term extension period|All participants who entered and received at least 1 dose of study medication during the long-term extension period||participants|||Number
736820|NCT00430677|Secondary|Change in Quantitative Immunoglobulin From Baseline During Short-term Period|"A quantitative immunoglobulin (Ig) test is used to detect abnormal levels of the 3 major classes of Ig (IgG, IgA, and IgM). Abnormal test results typically indicate that something is affecting the immune system and further testing is required.
Please refer to Outcome 31 for the respective baseline values"|Day 365|All randomized participants who received treatment. n=Participants with both postbaseline and baseline measurements||mg/dL||Standard Deviation|Mean
736821|NCT00430677|Secondary|Baseline Quantitative Immunoglobulins During the Short-term Period|A quantitative immunoglobulins (Igs) test is used to detect abnormal levels of the three major classes of Igs (IgG, IgA, and IgM). Abnormal test results typically indicate that there is something affecting the immune system which requires further testing.|Baseline (Day 1)|||mg/dL||Standard Error|Mean
736822|NCT00430677|Secondary|Number of Participants With Positive Abatacept-induced Responses (ECL Method) Over Time During the Short-term Period|A validated, sensitive electrochemiluminescence (ECL) immunoassay based on Meso-Scale Discovery instrumentation was used to evaluate immunogenicity. The ECL assay differentiated between two antibody specificities: (1) the ‘Ig and/or Junction (Jn) Region’ and (2) ‘CLTA4 and possibly Ig’. A sample was considered positive if it had a titer of 10 or greater and if immunodepletion was observed with abatacept with or without CTLA4-T.|Day 169, Day 365|Immunogenicity analysis population consisted of participants who received at least 1 dose of abatacept and had at least 1 immunogenicity result available. n= number of participants who are evaluated||Participants|||Number
736823|NCT00430677|Secondary|Vital Signs Summary During the Short-term Period: Temperature||0 - 12 Months|All participants who received at least one dose of double-blind study medication were included in the safety population. n= number of participants with a measurement at the select time point.||degree celcius||Standard Deviation|Mean
736824|NCT00430677|Secondary|Vital Signs Summary During the Short-term Period: Heart Rate||0 - 12 Months|All participants who received at least one dose of double-blind study medication were included in the safety population. n= number of participants with a measurement at the select time point.||beats per minute||Standard Deviation|Mean
736825|NCT00430677|Secondary|Vital Signs Summary During the Short-term Period: Diastolic Blood Pressure (DBP)||0 - 12 Months|All participants who received at least one dose of double-blind study medication were included in the safety population. n= number of participants with a measurement at the select time point.||mm Hg||Standard Deviation|Mean
736826|NCT00430677|Secondary|Vital Signs Summary During the Short-term Period: Systolic Blood Pressure (SBP)||0 - 12 Months|All participants who received at least one dose of double-blind study medication were included in the safety population. n= number of participants with a measurement at the select time point.||mmHg||Standard Deviation|Mean
736827|NCT00430677|Secondary|Participants With Marked Abnormalities Urinalysis During the Short-term Period|PTV=pretreatment value. Criteria for marked abnormality: Protein, glucose, blood, leukocyte esterase , if missing PTV then use >=2+ (or, if value >=4, or if PTV=0 or 0.5, >=2 or if PTV=1, >=3, or if PTV=2 or 3, >=4).|From Baseline (Day 1) up to 56 days post last dose in the double-blind period or the first dose in the open-label long-term extension, whichever occurred first.|All participants who received at least one dose of double-blind study medication were included in the safety population. n= number of participants with both post-baseline and baseline measurements||Participants|||Number
736828|NCT00430677|Secondary|Participants With Marked Liver and Kidney Function Abnormalities During the Short-term Period|"ULN=upper limit of normal; PTV=pretreatment value. Normal ranges are provided by the Central Laboratory and may vary according to sex and age.
Alkaline Phosphatase:>2x ULN; ↑Aspartate Aminotransferase: >3x ULN; ↑Alanine Aminotransferase : >3x ULN; G-Glutamyl Transferase : >2x ULN; ↑Total Bilirubin : >2x ULN or if PTV > ULN then > 4x PTV; ↑Blood Urea Nitrogen >2x PTV; ↑Creatinine >1.5x PTV."|From Baseline (Day 1) up to 56 days post last dose in the double-blind period or the first dose in the open-label long-term extension, whichever occurred first.|All participants who received at least one dose of double-blind study medication were included in the safety population. n= number of participants with both post-baseline and baseline measurements||Participants|||Number
736829|NCT00430677|Secondary|Participants With Marked Laboratory Abnormalities During the Short-term Period|LLN=lower limit of normal; ULN=upper limit of normal; PTV=pretreatment value. Normal ranges are provided by the Central Laboratory and may vary according to sex and age. ↑Serum Sodium:>1.05x ULN;↓Serum Potassium:<0.9x LLN;↑Serum Potassium:>1.1x ULN;↓Total Calcium:<0.8X LLN;↑Total Calcium:>1.2x ULN; ↓Serum Glucose(SG):<65 mg/dL;↑SG:>220 mg/dL;↓Fasting SG:<0.8x LLN;↑Fasting SG:>1.5x ULN;↓Total Protein:<0.9x LLN;↓Albumin:<0.9x LLN;↑Total Cholesterol:>2x PTV;↑Triglycerides:>=2.5x ULN;↑Fasting Triglycerides:>=2x ULN|From Baseline (Day 1) up to 56 days post last dose in the double-blind period or the first dose in the open-label long-term extension, whichever occurred first.|All participants who received at least one dose of double-blind study medication were included in the safety population. n= number of participants with both post-baseline and baseline measurements||Participants|||Number
736896|NCT00436748|Secondary|Maximum Increase in Hemoglobin Over Any 2 Week Period|The maximum increase between any 2 non-missing hemoglobin measurements over any 2-week period from Day 1.|25 weeks|Safety analysis set||g/dL/2 weeks||Standard Deviation|Mean
736830|NCT00430677|Secondary|Participants With Marked Hematology Abnormalities During the Short-term Period|LLN=lower limit of normal; ULN=upper limit of normal; PTV=pretreatment value. Normal ranges are provided by the Central Laboratory and may vary according to sex and age. Low(↓)Hemoglobin:>3g/dL decrease from PTV; ↓Hematocrit:<0.75xPTV;↓Erythrocyte count:<0.75xPTV; high(↑)Platelet count:>1.5xULN;↓Platelet count:<0.67xLLN;↓Leukocyte count:<0.75X LLN;↑Leukocyte count:>1.25xULN;↓Absolute(AB)Neutrophils+Bands:<1.00x10^3c/uL;↑AB Lymphocyte count:>7.50x10^3 c/uL; ↓AB lymphocyte count:<0.750x10^3 c/uL;↑AB monocyte count:>2000/mm^3;↑AB basophil count:>400/mm^3;↑AB eosinophil count:>0.750x10^3 c/uL.|From Baseline (Day 1) up to 56 days post last dose in the double-blind period or the first dose in the open-label long-term extension, whichever occurred first.|All participants who received at least one dose of double-blind study medication were included in the safety population. n= number of participants with both post-baseline and baseline measurements||Participants|||Number
736831|NCT00430677|Secondary|Participants With AEs of Special Interest During the Short-term Period|AEs of special interest were prospectively identified to be those that may be associated with the use of immunomodulatory agents. They are a subset of all AEs and may be either serious or non-serious.|From Baseline (Day 1) up to 56 days post last dose in the double-blind period or the first dose in the open-label long-term extension, whichever occurred first.|All participants who received at least one dose of double-blind study medication were included in the safety population.||Participants|||Number
736832|NCT00430677|Secondary|Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs Reported During the Short-term Period|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=possibly, probably, or certainly related to and of unknown relationship to study drug.|From Baseline (Day 1) up to 56 days post last dose in the double-blind period or the first dose in the open-label long-term extension, whichever occurred first.|All participants who received at least one dose of double-blind study medication were included in the safety population.||Participants|||Number
736833|NCT00430677|Secondary|Change in Fatigue From Baseline as Measured by Fatigue Severity Scale-Krupp During Short-term Period|The reduction of fatigue assessed by Fatigue Severity Scale (FSS). The FSS questionnaire is comprised of 9 statements inquiring about the examinee's sleep habits over the preceding week. Participants are asked to rate their level of agreement (toward seven) or disagreement (toward zero) with the nine statements. A score of 36 and above (out of a maximum of 63) indicates the presence of significant fatigue.|Baseline (Day 1), Days 85, 169, 253, and 365|ITT population (all randomized and treated subjects). To be included in analysis of change from baseline to time point with last observation carried forward, subjects must have had a baseline measurement and at least 1 post baseline measurement. n= Number of participants with both post-baseline and baseline measurements.||Units on a scale||Standard Error|Least Squares Mean
736834|NCT00430677|Secondary|Baseline Fatigue as Measured by Fatigue Severity Scale-Krupp During Short-term Period|The reduction of fatigue assessed by Fatigue Severity Scale (FSS). The FSS questionnaire is comprised of 9 statements inquiring about the examinee's sleep habits over the preceding week. Participants are asked to rate their level of agreement (toward seven) or disagreement (toward zero) with the nine statements. A score of 36 and above (out of a maximum of 63) indicates the presence of significant fatigue.|Baseline (Day 1), Days 85, 169, 253, and 365|n= Number of participants with both post-baseline and baseline measurements. Time-matched baseline (Day 1) values and post-baseline values are presented for each post-baseline visit and represent only that cohort of participants with measurement available at that post-baseline assessment.||Units on a scale||Standard Deviation|Mean
736835|NCT00430677|Secondary|Change in Fatigue From Baseline as Measured by the Fatigue Visual Analog Scale During Short-term Period|"A visual analogue scale is a psychometric response scale for measurement of subjective characteristics or attitudes that cannot be directly measured.
The VAS for Fatigue (VAS-F) consists of a 100 mm line, with 0 (No Fatigue) on 1 end and 100 (Extreme Fatigue) on the other end, which a participant marks to indicate how much fatigue he or she feels. The marked point in mm is converted into a numeric value from 0 to 100, where 0=no fatigue and 100=maximum fatigue. Increasing numbers=increasing fatigue."|Baseline (Day 1), Days 85, 169, 253, and 365|ITT population; all randomized and treated subjects. To be included in analysis of change from baseline to time point with last observation carried forward, participants must have had a baseline measurement and at least 1 post baseline measurement. n= Number of participants with both post-baseline and baseline measurements.||Units on a scale||Standard Error|Mean
736836|NCT00430677|Secondary|Baseline Fatigue as Measured by the Fatigue Visual Analog Scale During Short-term Period|A visual analogue scale (VAS) is a psychometric response scale for measurement of subjective characteristics or attitudes that cannot be directly measured. The VAS for Fatigue (VAS-F) consists of a 100 mm line, with 0 (No Fatigue) on 1 end and 100 (Extreme Fatigue) on the other end, which a participant marks to indicate how much fatigue he or she feels. The marked point in mm is converted into a numeric value from 0 to 100, where 0=no fatigue and 100=maximum fatigue. Increasing numbers=increasing fatigue.|Baseline (Day 1), Days 85, 169, 253, and 365|n= Number of participants with both post-baseline and baseline measurements. Time-matched baseline (Day 1) values and post-baseline values are presented for each post-baseline visit and represent only that cohort of participants with measurement available at that post-baseline assessment.||Units on a scale||Standard Deviation|Mean
736837|NCT00430677|Secondary|Change From Baseline in Mental Component Summary of the SF-36 During Short-term Period|The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.|Baseline (Day 1), Days 85, 169, 253, and 365|ITT population; all randomized and treated subjects. To be included in analysis of change from baseline to time point with last observation carried forward (LOCF), participants must have had a baseline measurement and at least 1 post baseline measurement. n= Number of participants with both post-baseline and baseline measurements.||Units on a scale||Standard Error|Mean
736838|NCT00430677|Secondary|Baseline Mental Component Summary of the Short SF-36 During Short-term Period|The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.|Baseline (Day 1), Days 85, 169, 253, and 365|n= Number of participants with both post-baseline and baseline measurements. Time-matched baseline (Day 1) values and post-baseline values are presented for each post-baseline visit and represent only that cohort of participants with measurement available at that post-baseline assessment.||Units on a scale||Standard Deviation|Mean
736839|NCT00430677|Secondary|Change From Baseline in Physical Component Summary of the SF-36 During Short-term Period|The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.|Baseline (Day 1), Days 85, 169, 253, and 365|ITT population; all randomized and treated subjects. To be included in analysis of change from baseline to time point with last observation carried forward, subjects must have had a baseline measurement and at least 1 post baseline measurement. n= Number of participants with both post-baseline and baseline measurements.||Units on a scale||Standard Error|Mean
736840|NCT00430677|Secondary|Baseline Physical Component Summary of the Short Form (SF)-36 During Short-term Period|The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.|Baseline (Day 1), Days 85, 169, 253, and 365|n= Number of participants with both post-baseline and baseline measurements. Time-matched baseline (Day 1) values and post-baseline values are presented for each post-baseline visit and represent only that cohort of participants with measurement available at that post-baseline assessment.||Units on a scale||Standard Deviation|Mean
736841|NCT00430677|Secondary|Change in SLICC/ACR Damage Index From Baseline During Short-term Period|SLICC/ACR score or damage index is a measure of cumulative damage due to Systemic Lupus Erythematosus (SLE). Damage is defined as non-reversible change (not related to active inflammation) occurring since onset of lupus, ascertained by clinical assessment and present for at least 6 months. A score of 0=no damage, early damage is defined as ≥1. The total maximum score is 48, and increasing score indicates increasing disease severity. Change from baseline=Postbaseline - baseline value.|Baseline (Day 1), Postbaseline (Month 12 or 28 days after last dose)|All randomized participants who received treatment and who had postbaseline and baseline measurements showing nonreversible changes (change from baseline >=0) in the SLICC-ACR Damage Index||Units on a scale||Standard Error|Mean
736842|NCT00430677|Secondary|Number of Participants Achieving Renal Response (RR) at Month 12 During Short-term Period|RR is defined as meeting BOTH of the following criteria:RENAL FUNCTION: Less than or equal to 25% increase from baseline;PROTEINURIA: Greater than or equal to 50% improvement in the urine protein/creatinine ratio with one of the following - urine protein/creatinine ratio (UPCR) <113 mg/mmol,, if the baseline ratio was <=339 mg/mmol OR UPCR <339 mg/mmol,if the baseline ratio > 339 mg/mmol. A participant was considered as achieving RR if response criteria at both months 11 and 12 (Days 337 and 365, respectively) were met. For 95% CI within each group, normal approximation is used if n>=5.|Month 12|All randomized participants who received treatment. Missing response values were imputed as nonresponders for participants who discontinued early after receiving study medication.||Participants||95% Confidence Interval|Number
736843|NCT00430677|Other Pre-specified|Number of Participants Achieving Patient Response (PR) at Month 12 During the Short-term Period|"PR is either CRR, Partial Renal Response(PRR),or no Response(NR).
CRR= Serum creatinine(SC)is normal, Inactive urinary sediment, No cellular casts, Urinary protein/creatinine (UPCR) ratio <56.5 mg/mmoL; PRR= SC is normal OR SC not >25% above BL, RBCs at reference range, UPCR <56.5 mg/mmoL OR ≥50% improvement in UPCR with one of the following: UPCR <113 or <339 mg/mmoL, based on the BL ratio; NR= Not achieving either a CRR or a PRR. Participants achieved response if criteria at both months 11 and 12 (Days 337 and 365) were met. Participants who Early discontinuations were categorized as NR."|Month 12|All randomized participants who received treatment.||Participants|||Number
736844|NCT00430677|Secondary|Baseline and Post Baseline Systemic Lupus International Collaborating Clinics (SLICC)/American College of Rheumatology (ACR) Damage Index During Short-term Period|SLICC/ACR score or damage index is a measure of cumulative damage due to Systemic Lupus Erythematosus (SLE). Damage is defined as nonreversible change (not related to active inflammation) occurring since onset of lupus, ascertained by clinical assessment and present for at least 6 months. A score of 0=no damage, early damage is defined as ≥1. The total maximum score is 48, and increasing score indicates increasing disease severity.|Baseline (Day 1), Post baseline (Month 12 or 28 days after last dose)|n=Participants with both post-baseline and baseline measurements showing non-reversible changes in the SLICC/ACR Damage Index (i.e., Change from Baseline greater than or equal to 0).||Units on a scale||Standard Deviation|Mean
736845|NCT00430677|Secondary|Change in Renal Function From Baseline Over Time During Short-term Period|Mean change from baseline in renal function, as estimated by calculation of the MDRD equation, over time. Renal MDRD is an equation (calculation) used to estimate Glomerular Filtration Rate (GFR) in participants with impaired renal function based on serum creatinine, age, race, and gender. GFR (mL/min/1.73 m^2) = 175 * (Scr)^-1.154 * (Age)^-0.203 * (0.742 if female) * (1.212 if African American) (conventional units). mL, milliliters; min, minute; m^2, meters squared; Scr, serum creatinine. A positive value indicates improvement. Change from baseline=Post-baseline-baseline value.|Baseline (Day 1), Day 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365|ITT population (all randomized and treated subjects). n= Number of participants with both baseline and post-baseline measurements for that time point.||milliliters per minute (mL/min)/1.73 m^2||Standard Error|Mean
736846|NCT00430677|Secondary|Baseline Renal Function Over Time During Short-term Period|Baseline (BL) renal function, as estimated by calculation of the MDRD (Modification of Diet in Renal Disease) equation, over time. Renal MDRD is an equation (calculation) used to estimate Glomerular Filtration Rate (GFR) in participants with impaired renal function based on serum creatinine, age, race, and gender. GFR (mL/min/1.73 m^2) = 175 * (Scr)^-1.154 * (Age)^-0.203 * (0.742 if female) * (1.212 if African American) (conventional units). mL, milliliters; min, minute; m^2, meters squared; Scr, serum creatinine. A negative value indicates worsening.|Baseline (Day 1), Day 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365|n= Number of participants with measurements for that time point. Time-matched baseline (Day 1) values and post-baseline values are presented for each post-baseline visit and represent only that cohort of participants with measurement available at that post-baseline assessment.||milliliters per minute (mL/min)/1.73 m^2||Standard Deviation|Mean
736847|NCT00430677|Secondary|Number of Months CRR Was Maintained During Short-term Period|Durability of CRR, defined as the number of months (number of consecutive planned visits beyond Day 15) a participant met the definition of CRR during the double-blind treatment period. Refer to outcome 1 for description of CRR.|Day 1 (randomization) to 12 Months|All randomized participants who received participants.||Months||Full Range|Median
736848|NCT00430677|Secondary|Participants Achieving Renal Improvement (RI) or CRR at Month 12 During Short-term Period|CRR defined as meeting all of 5 criteria. RF: (Glomerular filtration rate [GFR] calculated using MDRD equation) Calculated function abnormal at screening visit - return of renal function to greater than or equal to 90% of function at approximately 6 months prior to onset of the current episode of lupus nephritis. Calculated function normal at screening visit - estimated renal function 90% or greater of level at screening visit. Proteinuria: urinary protein/creatinine ratio <30 mg/mmol. Hematuria: red blood cell (RBC) count within normal limits of Central Laboratory. Pyuria: White blood cell count (WBC) within normal limits of Central Laboratory. Cylindruria: No RBC or WBC casts reported.|At Month 12 from Day 1|All randomized participants who received treatment. Missing response values were imputed as nonresponders for participants who discontinued early after receiving study medication.||Participants||95% Confidence Interval|Number
736849|NCT00430677|Secondary|Time to Achieve First Confirmed Renal Improvement (RI) During Short-term Period (as Determined by Kaplan-Meier Methodology)|RI is defined as meeting all of the following criteria. Renal function: If MDRD is abnormal at screening, within 10% of the MDRD at screening; if MDRD is 60-89 at screening, greater than or equal to 50% improvement based on the screening value or 90% or greater of MDRD at screening; if MDRD is 15-59 at screening, if MDRD is normal at screening-within 10% of the MDRD at screening. Proteinuria: improvement greater than or equal to 50% from screening. Hematuria: red blood cell (RBC)count within normal limit of central laboratory. Pyuria: white blood cell (WBC) count within normal limit of central laboratory. Cylindruria: No RBC or WBC casts.|Day 1 (randomization) to 12 months.|All randomized participants who received treatment. Includes participants who died and who were censored at the time of discontinuation||Days||95% Confidence Interval|Median
736850|NCT00430677|Secondary|Participants Achieving a Confirmed Complete Renal Response (CRR) at Month 12 During Short-term Period|Confirmed at 2 consecutive visits. CRR defined as meeting all of 5 criteria. Renal function (RF): (Glomerular filtration rate [GFR] calculated using Modification of Diet in Renal Diseases equation equation) Calculated function abnormal at screening visit - return of renal function to greater than or equal to 90% of function at approximately 6 months prior to onset of the current episode of lupus nephritis. Calculated function normal at screening visit - estimated renal function 90% or greater of level at screening visit. Proteinuria: urinary protein/creatinine ratio <30 mg/mmol. Hematuria: red blood cell (RBC) count within normal limits of Central Laboratory. Pyuria: White blood cell count (WBC) within normal limits of Central Laboratory. Cylindruria: No RBC or WBC casts reported.|At Month 12 from Day 1|All randomized participants who received treatment. Missing response values were imputed as nonresponders for participants who discontinued early after receiving study medication.||Participants|||Number
736851|NCT00430677|Secondary|Number of Participants With Confirmed Complete Renal Response (CRR) During Short-term Period|Confirmed at 2 consecutive visits. CRR defined as meeting all of 5 criteria. Renal function (RF): (Glomerular filtration rate [GFR] calculated using Modification of Diet in Renal Diseases equation equation) Calculated function abnormal at screening visit - return of renal function to greater than or equal to 90% of function at approximately 6 months prior to onset of the current episode of lupus nephritis. Calculated function normal at screening visit - estimated renal function 90% or greater of level at screening visit. Proteinuria: urinary protein/creatinine ratio <30 mg/mmol. Hematuria: red blood cell (RBC) count within normal limits of Central Laboratory. Pyuria: White blood cell count (WBC) within normal limits of Central Laboratory. Cylindruria: No RBC or WBC casts reported.|Day 1 to 12 months|All randomized participants who received treatment. Participants who discontinued early without meeting the confirmed CRR criteria were imputed as nonresponders.||Participants|||Number
736852|NCT00430677|Primary|Time to First Confirmed Complete Renal Response (CRR) During the Short-term (Double-blind) Period|Confirmed at 2 consecutive visits. CRR defined as meeting all of 5 criteria. Renal function (RF): (Glomerular filtration rate [GFR] calculated using Modification of Diet in Renal Diseases equation equation) Calculated function abnormal at screening visit - return of renal function to greater than or equal to 90% of function at approximately 6 months prior to onset of the current episode of lupus nephritis. Calculated function normal at screening visit - estimated renal function 90% or greater of level at screening visit. Proteinuria: urinary protein/creatinine ratio <30 mg/mmol. Hematuria: red blood cell (RBC) count within normal limits of Central Laboratory. Pyuria: White blood cell count (WBC) within normal limits of Central Laboratory. Cylindruria: No RBC or WBC casts reported.|Day 1 (randomization) to 12 months.|All randomized participants who received treatment. Includes participants who died and who were censored at the time of discontinuation.||days|||Number
736853|NCT00430716|Secondary|Change From Baseline in BORG Dyspnoea Score at Week 12|BORG dyspnoea scale is a 10-point scale where following scores stands for severity of dyspnoea: 0 (no breathlessness at all); 0.5 (very very slight [just noticeable]); 1 (very slight); 2 (slight breathlessness); 3 (moderate); 4 (some what severe); 5 (severe breathlessness); 7 (very severe breathlessness); 9 (very very severe [almost maximum] and 10 (maximum).|Baseline and Week 12|ITT population included all participants who were randomized to study treatment and received at least 1 dose of study medication. If participant had missing value at any visit, LOCF method of imputation was used.||Units on a scale||95% Confidence Interval|Mean
736856|NCT00430716|Secondary|Change From Baseline in BNP at Week 12|BNP is a non-invasive biomarker and an indicator of progression of PAH/ RV dysfunction in participants with PAH.|Baseline and Week 12|ITT population included all participants who were randomized to study treatment and received at least 1 dose of study medication. If participant had missing value at any visit, LOCF method of imputation was used.||pg/mL||95% Confidence Interval|Mean
736857|NCT00430716|Secondary|Number of Participants With Change From Baseline in PAH Criteria for Functional Capacity and Therapeutic Class at Week 12|PAH Criteria for WHO Class: Class I (Participants without resulting limitation of physical activity);Class II (Participants with slight limitation of physical activity though comfortable at rest);Class III (Participants with marked limitation of physical activity,though comfortable at rest);Class IV(Participants with inability to carry out any physical activity without symptoms,manifest signs of right heart failure; dyspnoea and/or fatigue may even be present at rest; and discomfort is increased by any physical activity).|Baseline and Week 12|ITT population included all participants who were randomized to study treatment and received at least 1 dose of study medication. If participant had missing value at any visit, LOCF method of imputation was used.||Participants|||Number
736858|NCT00430716|Secondary|Time to Clinical Worsening|Clinical worsening was defined as death; or lung transplantation; or hospitalization due to pulmonary hypertension; or initiation of prostacyclin therapy; or initiation of endothelin receptor antagonist therapy.|Baseline through Week 12|Due to very low number of events of clinical worsening reported, the statistical analysis was not conducted and hence data not reported.||Days||Standard Error|Mean
736859|NCT00430716|Secondary|Change From Baseline in mPAP at Week 12|mPAP was measured using a pressure transducer positioned at the mid-axillary line.|Baseline and Week 12|ITT population included all participants who were randomized to study treatment and received at least 1 dose of study medication. If participant had missing value at any visit, LOCF method of imputation was used.||mmHg||95% Confidence Interval|Mean
736860|NCT00430716|Primary|Change From Baseline in the Total Distance Walked During 6MWT at Week 12|6 MWT was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. Continuous pulse oximetry was conducted during the test for safety.|Baseline and Week 12|Intention to Treat (ITT population) included all participants who were randomized to study treatment and received at least 1 dose of study medication. If participant had missing value at any visit, last observation carried forward (LOCF) method of imputation was used.||Meters||95% Confidence Interval|Mean
736861|NCT00430755|Primary|Detection of Medical Problems (by Number of Problems Reported by Computer Assisted History, That Were Not Reported by Physician Taken History)|Data were extracted from hospital charts by to experienced physicians.; data from the computer histories were extracted by a senior physician, who tabulated comparisons between the 2 sets of records. We used the number of problems reported by Computer Assisted History that were not reported by Physician. Nurses at Robert Bosch Krankenhaus do not take medical histories in regard to allergies or adverse drug reactions. Pharmacists make no entries into charts and have no separate records of drug allergies or history of adverse drug reactions. Data on these issues either are obtained only by physician interview of the patient.|participants were followed for the duration of hospital stay, an average of 8 days|The rest did not end the history tool||medical problems|||Number
736862|NCT00430768|Secondary|hAAT Expression in Blood Measured Using M-specific Allele ELISA|4 subjects received prior AAT augmentation therapy; 2 subjects from Group 1 having only washed out for only 28 days complicated the measurement of M-specific levels 2 subjects from group 1 and the other subject did not have an appreciable change in M-specific AAT levels. Thus reporting only Cohorts 2 and 3. After day 90 patients were able to resume AAT protein therapy and thus levels were not collected following commencement of therapy on 201 and 303. 202, Day 365 blood hemolyzed; level not determinable.|Baseline, Days 14, 30, 45, 60, 90, (180, 270, and 365 if not on protein replacement therapy)|AAT Levels of each subject at various time points Baseline and Days following administration. 202 Day 365 blood hemolyzed; not determinable, 201 and 303 went back on AAT protein augmentation therapy after day 90, unable to collect M-specific levels on day 180, 270 and 303.||nM|||Number
736863|NCT00430768|Primary|Adverse Events Possibly, Probably or Definitely Related to Study Drug|"Adverse events considered possibly, probably or definitely related to study drug/study drug procedure Criteria to evaluate severity according to Attachment 2 of the Protocol
Mild toxicity, usually transient, requiring no special treatment and generally not interfering with usual daily activities
Moderate toxicity which may be ameliorated by simple therapeutic maneuvers, and impairs usual activities
Severe toxicity which requires therapeutic intervention and interrupts usual activities. Hospitalization may or may not be required
Life-threatening toxicity which requires hospitalization"|During 1 year after study agent administration|subjects in the group reporting the event||participants|||Number
736864|NCT00430781|Primary|Progression-free Survival (PFS) in Final Analysis|PFS is defined as the interval between the date of randomization and the date of disease progression or death due to any cause. This study began as a 3-arm study. The combination arm was terminated at the interim analysis. The monotherapy arms continued to final analysis. Data shown here are from the final analysis.|From Randomization until 105 total PFS events in combined population of two monotherapy arms (up to 85.57 weeks)|ITT Population||Weeks||90% Confidence Interval|Median
736865|NCT00430781|Secondary|Safety and Tolerability of Pazopanib, Lapatinib and the Combination of Pazopanib and Lapatinib|Safety was assessed as the number of participants experiencing a serious adverse event (SAE) or an adverse event (AE). See the adverse event module for safety data.|From Randomization (11 December 2006) until last participant had last visit (28 July 2011) in combined population of two monotherapy arms (up to 241.43 weeks)|Safety Population: all participants who received at least one dose of study drug||participants|||Number
736866|NCT00430781|Secondary|Duration of Response|For participants who had a CR or PR, the duration of response was defined as the time from first documented evidence of PR or CR until the first documented sign of disease progression or death. CR, all detectable tumor has disappeared; PR, a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum.|From Randomization until 105 total PFS events in combined population of two monotherapy arms (up to 85.57 weeks)|ITT Population. The median for lapatinib was not reached at the time of data cut-off. No formal analysis of this endpoint was conducted for this group due to a very small number of responding participants.||weeks||90% Confidence Interval|Mean
736897|NCT00436748|Secondary|Number of Participants With Hemoglobin > 12.0, > 13.0, and > 14.0 g/dL During the Study||25 weeks|Safety analysis set||participants|||Number
736867|NCT00430781|Secondary|Time to Response|For the subset of participants who showed a confirmed CR or PR, time to response was defined as the time from randomization until the first documented evidence of CR or PR (whichever status was recorded first). CR, all detectable tumor has disappeared; PR, a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum.|From Randomization until 105 total PFS events in combined population of two monotherapy arms (up to 85.57 weeks)|ITT Population||weeks||90% Confidence Interval|Mean
736868|NCT00430781|Secondary|Response|Response is defined as the number of participants achieving either a complete or partial tumor response per RECIST criteria. CR, all detectable tumor has disappeared; PR, a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum.|From Randomization until 105 total PFS events in combined population of two monotherapy arms (up to 85.57 weeks)|ITT Population||participants|||Number
736869|NCT00430781|Secondary|Clinical Benefit Response|Clinical benefit response is defined as the number of participants with evidence of complete (CR) or partial (PR) tumor response or stable disease (SD) for at least 6 months (183 days). Per Response Evaluation Criteria In Solid Tumors (RECIST): CR, all detectable tumor has disappeared; PR, a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum; Stable Disease, small changes that do not meet previously given criteria. Confirmation requires at least 2 assessments of CR/PR with at least 4 weeks between assessments.|From Randomization until 105 total PFS events in combined population of two monotherapy arms (up to 85.57 weeks)|ITT Population||participants|||Number
736870|NCT00430781|Secondary|Overall Survival|Overall survival is defined as the time from randomization until death due to any cause.|From Randomization (11 December 2006) until approximately 78% overall survival events at the time of the second overall survival update (3 March 2010) (up to 168.29 weeks)|ITT Population||Weeks||90% Confidence Interval|Median
736871|NCT00430781|Primary|Progression-free Survival (PFS) in Interim Analysis|PFS is defined as the interval between the date of randomization and the date of disease progression or death due to any cause. The study was designed to test Combination vs. Lapatinib first. The result indicated that Combination would not show improvement over Lapatinib even if followed until the final analysis and the Combination arm was terminated. The monotherapy arms continued to the final analysis. Data shown here are from this interim analysis.|From randomization until at least 35 PFS events in pairwise comparison of the three treatment arms (Interim Analysis; up to 52.14 weeks)|Intent to Treat (ITT) Population: all randomized participants||Weeks||90% Confidence Interval|Median
736872|NCT00430937|Secondary|Microbiological Efficacy Measured by the Number of Participants Achieving Bacteriological Eradication of Gram-positive Baseline Pathogens at the TOC Visit.|"Microbiological Success: All infecting Gram-positive pathogens isolated at baseline were eradicated at the TOC evaluation and a superinfecting pathogen was not isolated either prior to or at the TOC evaluation.
Microbiological Failure: Persistence of one or more infecting Gram-positive pathogens or isolation of a superinfecting pathogen prior to or at the TOC evaluation."|Baseline to TOC Visit (7-14 days after end of treatment) up to 4 weeks|Population analyzed consisted of patients from the clinically evaluable population who had microbiological assessments.||Participants|||Number
736873|NCT00430937|Primary|"Clinical Success as Measured by Comparing the Participants Signs and Symptoms at the Test of Cure (TOC) Visit to Those Recorded at Study Baseline in the Clinically Evaluable Population."|"Success: Total resolution of clinically significant signs and symptoms of the infection site (cure) or improvement to such a level that no further antibacterial therapy was required (improvement).
Failure: Persistence or progression of signs and symptoms after at least 3 days of study therapy, or development of new signs and symptoms at the infection site, or concomitant or additional antibacterial therapy with documented activity against isolated organisms, or a treatment duration greater than 14 days, or requirement of a major surgical procedure as adjunct or follow-up therapy."|Baseline to TOC Visit (7-14 days after end of treatment) up to 4 weeks|The clinically evaluable population was used for the efficacy analysis. It included all patients who met the criteria for cSSTI as listed in the Protocol, had no substantive protocol deviation, had a sponsor clinical response assessment of “success” or “failure” at the assessment visit, and had a specified baseline primary site of infection.||Participants|||Number
736879|NCT00431041|Secondary|Change From Baseline in Urgency Episodes as Reported in Subject 3-day Diary|"Subjects were instructed to complete the diary in the 3 day period immediately preceding the visit. Subjects recorded each urgency episode or instance of strong desire to pass urine.
The mean was calculated for each time point as the average of the day 1-3 measurements from the associated 3 day diary. Change from Baseline was calculated as Week 8- Baseline."|Baseline and 8 weeks|Data represents ITT Population: all randomized subjects. The numbers of subjects for each time point are noted in the category titles. Data for week 8 and Change from Baseline to week 8 includes all subjects who completed the study||urgency episodes per day||Standard Deviation|Mean
737285|NCT00448630|Secondary|Metabolic Syndrome Parameter BMI by Treatment Group|Iterative measurement of BMI. Mean at time points.|Baseline, 1 Month, 4 Months|Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.||kg/m*m||Standard Deviation|Mean
736880|NCT00431041|Secondary|Change From Baseline in Micturition Frequency as Reported in Subject 3-day Diary|"Subjects were instructed to complete the diary in the 3 day period immediately proceding the visit. Subjects recorded each micturition or instance of passing urine in the toliet.
The mean was calculated for each time point as the average of the day 1-3 measurements from the associated 3 day diary. Change from baseline was calculated as Week 8- Baseline."|Baseline and 8 Weeks|Data represents ITT Population: all randomized subjects. The numbers of subjects for each time point are noted in the category titles. Data for week 8 and Change from Baseline to week 8 includes all subjects who completed the study||Micturitions per day||Standard Deviation|Mean
736881|NCT00431041|Primary|The Severity of Dry Mouth Reported as an Adverse Event|"The number of subjects reporting dry mouth at each severity level when dry mouth was reported as an Adverse Event (AE).
Dry mouth severity was categorized as mild (relieved with fluid/hard candy), moderate (dry mouth and throat with no difficulty swallowing solid food/water) & severe (very dry mouth & throat, difficulty swallowing solid food without water)"|8 weeks|Data represents ITT Population: all randomized subjects||participants|||Number
736882|NCT00431041|Primary|The Number of Subjects Reporting Incidence of Dry Mouth as an Adverse Event|The number of subjects reporting incidence of dry mouth as an adverse event (AE) following direct questioning at each patient follow-up visit|8 weeks|Data represents ITT Population: all randomized subjects||participants|||Number
736883|NCT00431067|Secondary|Duration of Confirmed OR|Duration of confirmed OR is measured from the time of first OR to the time of progression or death (or date of censoring for progression free survival).|From first OR to time of progression or death|TS - patients with OR only.||days||Standard Deviation|Mean
736884|NCT00431067|Secondary|Time to RECIST Tumour Reponse|The time to OR was the duration from the first treatment to the time when the measurement criteria for CR and/or PR were met according to RECIST criteria.|From first dose of study medication to time when OR measurement was taken.|TS. There were only 4 patients who responded.||days||95% Confidence Interval|Median
736885|NCT00431067|Secondary|Overall Survival (OS)|OS was defined as the time from first treatment to death or to the last date the patient was known to be alive.|From first dose of study medication to death or to the last date the patient was known to be alive, up to 34 month|TS (14 patients died)||days||95% Confidence Interval|Median
736886|NCT00431067|Secondary|Progression Free Survival (PFS)|PFS was defined as the time from the first treatment to the occurrence of tumour progression or death, whichever came first. It was assessed according to RECIST criteria.|From first dose of study medication to the occurrence of progression or death whichever came first, up to 34 month|TS||days||95% Confidence Interval|Median
736887|NCT00431067|Primary|Objective Response (OR)|Objective response (OR) including complete response (CR) and partial response (PR) according to the Response Evaluation Criteria in Solid Tumours (RECIST) criteria .|From first dose of study medication to response measurement, up to 34 month|Treated set (TS). TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.||Participants|||Number
736888|NCT00431132|Secondary|Transvaginal Ultrasound: Endometrial Thickness|Transvaginal ultrasounds were performed at Baseline (Week 0) and Week 52, or at the time of withdrawal in the case of a subject's premature discontinuation. Endometrial thickness, measured (double layer) in mm, were lesser than 4 mm for entry into the trial.|Week 0, week 52|Safety analyses using LOCF (last observation carried forward) were performed on the safety population, which was comprised of 336 (100%) subjects who received 52 weeks of treatment with Vagifem® 10 mcg of trial drug.||mm||Standard Deviation|Mean
736889|NCT00431132|Primary|Endometrial Hyperplasia Based on Histological Assessment of Endometrial Biopsies|The endometrial hyperplasia rate was calculated based on the number of patients with endometrial hyperplasia/endometrial carcinoma divided by the total number of subjects with interpretable biopsies at Week 52.|Week 52|Safety analyses using LOCF (last observation carried forward) were performed on the safety population, which was comprised of 336 (100%) subjects who received 52 weeks of treatment with Vagifem® 10 mcg of trial drug.||percentage of participants|||Number
736890|NCT00431184|Secondary|Young Mania Rating Scale (YMRS)|The YMRS is used to assess manic symptoms. There are 11 questions which ask the patient to rate the severity of symptoms. Scores range from 0 to a maximum of 60. All questions are rated based on severity, with a higher score signifying increased severity. Questions 1-4, 7, and 10 are rated on a 0-4 scale. Questions 5, 6, 8, and 9 are rated on a 0-8 scale.|at the time of administration of intervention and 5 hours following administration of intervention|||units on a scale||95% Confidence Interval|Mean
736891|NCT00431184|Primary|Mania Acute Rating Scale (MACS)|Assessment of current mania symptoms using Mania Acute Change Scale (MACS). All 20 questions on the scale have a 0 (absent)-4(most severe) range for describing mania symptoms. The mean MACS score totals were reported, with the total ranging from 0-80. A higher total score indicates a greater number of symptoms and higher symptom intensity, while a smaller score indicates a lesser number of symptoms and higher lower intensity. The change in MACS scores from baseline and those following treatment administration were averaged. The number below represents the average mean change.|On Day 1 and Day 2, at the time of administration of intervention and 5 hours following administration of intervention|||units on a scale||95% Confidence Interval|Mean
736892|NCT00436748|Secondary|Darbepoetin Alfa Serum Concentrations for Participants Less Than 6 Years of Age|Serum concentrations of darbepoetin alfa were measured by an enzyme-linked immunosorbent assay (ELISA).|Weeks 1, 2, and 3 before the investigational product dose and 2 days after the first investigational product dose|Due to the low number of participants <6 years of age summary concentration analyses were not performed.|||||
736893|NCT00436748|Secondary|Number of Participants Who Developed Anti-erythropoiesis Antibodies|Participants who were negative for anti-erythropoiesis antibodies at Baseline (pre-dose) and who developed anti-erythropoiesis antibodies during the study. Serum samples were tested using Amgen’s Surface Plasmon Resonance Immunoassay (SPRIA) method.|25 weeks|Safety analysis set with both pre and postdose immunoassay antibody results||participants|||Number
736894|NCT00436748|Secondary|Change From Baseline in Diastolic Blood Pressure Over Time||Baseline and Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 and 25.|"Safety analyis set with available data at each time point (indicated by n)."||mmHg||Standard Deviation|Mean
736895|NCT00436748|Secondary|Change From Baseline in Systolic Blood Pressure Over Time||Baseline and Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 and 25.|"Safety analyis set with available data at each time point (indicated by n)."||mmHg||Standard Deviation|Mean
736898|NCT00436748|Secondary|Hemoglobin Serial Rate of Change (ROC) Over Time|Calculated using the serial method as the change in hemoglobin from the previous non-missing hemoglobin level divided by number of days in between, and then multiplied by 7.|Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 and 25.|"Safety analyis set with available data at each time point (indicated by n)."||g/dL/week||Full Range|Median
736899|NCT00436748|Secondary|Number of Participants With Treatment-emergent Adverse Events|A serious adverse event (SAE) is defined as an adverse event that meets at least one of the following serious criteria: • is fatal, • is life threatening, • requires in-patient hospitalization or prolongation of existing hospitalization, • results in persistent or significant disability/incapacity, • is a congenital anomaly/birth defect, and/or • other significant medical hazard. The investigator assessed whether the adverse event was related to the investigational product (IP). Events of interest included hypertension, ischemic heart disease, cardiac failure, cerebrovascular disorders, convulsions, embolic and thrombotic events, embolic and thrombotic events: venous, embolic and thrombotic events: arterial, embolic and thrombotic events: vessel type unspecified and mixed arterial and venous, dialysis vascular access thrombosis, antibody-mediated pure red cell aplasia, hypersensitivity, lack of efficacy-effect, and malignancies.|25 weeks|Safety analysis set including all participants who received ≥ 1 dose of investigational product.||participants|||Number
736900|NCT00436748|Secondary|Change From Baseline at Week 13 and Week 25 in Child Self-reported Pediatric Quality of Life Inventory (PedsQL) Scores|The PedsQL child self-reported questionnaire was used in children > 5 years old. The 23-item PedsQL 4.0 includes physical functioning (8 items), emotional functioning (5 items), social functioning (5 items), and school functioning (5 items). Separate questionnaires for ages 5-7, 8-12, and 13-18 years was used for child self-reporting. The instructions asked how much of a problem each item has been during the past 1 month; each item is answered on a 5-point scale for ages 8 to 18 (0 = never a problem; 1 = almost never a problem; 2 = sometimes a problem; 3 = often a problem; 4 = almost always a problem), or simplified to a 3-point scale for ages 5 to 7 (0 = not at all a problem; 2 = sometimes a problem; 4 = a lot of a problem). Scores from the 4 subscales, the total score, and the psychosocial composite score were generated using standard algorithms. Each item’s score in the questionnaire was converted to a 0 to 100 scale (with higher scores indicating better HRQOL).|Baseline, Week 13 and Week 25 (or end of study visit if earlier than Week 25)|"Efficacy analysis set aged > 5 years and with available data for each score at each time point (indicated by n)."||units on a scale||Standard Error|Mean
736901|NCT00436748|Secondary|Change From Baseline at Week 13 and Week 25 in Parent-reported Pediatric Quality of Life Inventory (PedsQL) Scores|The PedsQL is a health-related quality of life (HRQOL) questionnaire that can be used to measure quality of life in children ≥ 2 years old. The 23-item PedsQL 4.0 includes physical functioning (8 items), emotional functioning (5 items), social functioning (5 items), and school functioning (5 items). Separate questionnaires for ages 2 to 4 (toddler), 5-7, 8-12, and 13-18 years are used for parent proxy-reporting, which assesses parents’ perceptions of their child’s HRQOL. The instructions ask how much of a problem each item has been during the past 1 month; each item is answered on a 5-point scale: 0 = never a problem; 1 = almost never a problem; 2 = sometimes a problem; 3 = often a problem; 4 = almost always a problem. Scores from the 4 subscales, the total score, and the psychosocial composite score were generated using standard algorithms. Each item’s score in the questionnaire was converted to a 0 to 100 scale (with higher scores indicating better HRQOL).|Baseline, Week 13 and Week 25 (or end of study visit if earlier than Week 25)|"Efficacy analysis set with available data for each score at each time point (indicated by n)."||units on a scale||Standard Error|Mean
736902|NCT00436748|Secondary|Darbepoetin Alfa Weight-Adjusted Dose Over Time|Arithmetic means are provided; Withheld doses are counted as 0 μg.|Day 1 (initial dose) and Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 and 25.|"Efficacy analyis set with available data at each time point (indicated by n). Numbers > 0 on non-darbepoetin alfa dosing weeks for the Q2W group reflect participants who did not receive the assigned placebo dose (eg, dose withheld per investigator decision based on hemoglobin value or missed visit)."||μg/kg||Standard Deviation|Mean
736903|NCT00436748|Secondary|Weight-adjusted Darbepoetin Alfa Dose at Time of Achieving First Hemoglobin ≥ 10.0 g/dL|The darbepoetin alfa dose at the time a participant achieved a first hemoglobin level ≥ 10.0 g/dL, divided by the participant's weight measured at the closest study week prior to the dosing, post dialysis.|24 weeks|Efficacy analysis set responders (participants with at least 1 postbaseline hemoglobin ≥ 10.0 g/dL) for whom dosing data were available.||μg/kg||Standard Deviation|Mean
736904|NCT00436748|Secondary|Hemoglobin Concentration Over Time||Baseline and Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 and 25.|"Efficacy analyis set with available data at each time point (indicated by n)."||g/dL||Standard Deviation|Mean
736905|NCT00436748|Secondary|Time to First Hemoglobin Value ≥ 10.0 g/dL|The time from study Day 1 to the day a participant first achieved hemoglobin ≥ 10.0 g/dL for participants who achieved hemoglobin ≥ 10.0 g/dL.|24 weeks|Efficacy analysis set responders (participants with at least 1 postbaseline hemoglobin ≥ 10.0 g/dL)||days||Inter-Quartile Range|Median
736906|NCT00436748|Primary|Proportion of Participants Achieving Hemoglobin ≥ 10.0 g/dL|The proportion of participants achieving hemoglobin ≥ 10.0 g/dL (the correction proportion) was calculated as the number of participants achieving a hemoglobin ≥ 10.0 g/dL at any time point during the study when administered de novo darbepoetin alfa without receiving any red blood cell transfusion after randomization and within 90 days before the achievement, divided by the number of participants in the efficacy analysis set.|24 weeks|Efficacy analysis set||proportion of participants||95% Confidence Interval|Number
736907|NCT00436826|Secondary|Annualized Qualifying Relapse Rate|A qualifying relapse was defined as a 2-grade increase in at least one, or a 1-grade increase in at least two, Kurtzke Functional Systems excluding bowel/bladder or cognition changes, in the absence of fever lasting more than or equal to 24 hours, and preceded by more than or equal to 30 days of clinical stability or improvement. The annualized relapse rate for each treatment group was the mean of the annualized relapse rates for all the participants in the group, calculated as the total number of confirmed relapses divided by the total number of days on study multiplied by 365.25.|Baseline up to Week 96|ITT population included all randomized participants who had received at least one dose of study medication in the DB period.||relapses per year||95% Confidence Interval|Number
736908|NCT00436826|Secondary|Number of Combined Unique Active (CUA) Lesions, Active Time Constant 2 (T2) Lesions, and Time Constant 1 (T1) Gadolinium Enhanced (Gd+) Lesions Per Participant Per Scan|Number of CUA lesions, active T2 lesions, and T1 Gd+ lesions were measured by using magnetic resonance imaging (MRI) scans|Week 96|ITT population included all randomized participants who had received at least one dose of study medication in the DB period.||Lesions||Standard Deviation|Mean
736909|NCT00436826|Secondary|Number of Qualifying Relapses|A qualifying relapse was defined as a 2-grade increase in at least one, or a 1-grade increase in at least two, Kurtzke Functional Systems excluding bowel/bladder or cognition changes, in the absence of fever lasting more than or equal to 24 hours, and preceded by more than or equal to 30 days of clinical stability or improvement.|Baseline up to Week 96|ITT population included all randomized participants who had received at least one dose of study medication in the DB period.||Relapses||Standard Deviation|Mean
736910|NCT00436826|Primary|Percentage of Participants With Adverse Events in Infections and Infestations System Organ Class (SOC)|Adverse Events were entered in infections and infestations SOC as per medical dictionary for regulatory activities (MedDRA) version 11.0|Baseline up to Week 96|Safety population included all randomized participants who received at least one dose of study medication in the DB period and had follow-up safety data.||Percentage of participants|||Number
736911|NCT00436826|Primary|Percentage of Participants With Grade 3 or 4 (Common Terminology Criteria for Adverse Events [CTCAE]) Hematological or Liver Toxicity|Percentage of participants with Grade 3 or 4 CTCAE toxicity on the following hematology and liver function parameters were reported: lymphocytes, cluster of differentiation 4 (CD4) cell, neutrophils, white blood cells, hemoglobin, Alanine transaminase (ALT) and Aspartate transaminase (AST). According to CTCAE: Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening or disabling and Grade 5=Death|Baseline up to Week 96|Safety population included all randomized participants who received at least one dose of study medication in the DB period and had follow-up safety data.||Percentage of participants|||Number
736912|NCT00436826|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered. SAE: Any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition.|Baseline up to Week 96|Safety population included all randomized participants who received at least one dose of study medication in the DB period and had follow-up safety data.||Participants|||Number
736913|NCT00436852|Secondary|Toxicity as Assessed by Common Terminology Criteria for Adverse Events Version 3.0|Toxicity will be tabulated by grade (overall and by course).|yearsFrom enrollment until 30 days after the end of protocol therapy||||||
736914|NCT00436852|Secondary|Quality of Life Measured by PedsQL™ Generic Core Scale Version 4.0|For each of the items within a Dimension, the QOL score will be reverse linearly transformed to a 0-100 percentage point scale (0=100, 1=75, 2=50, 3=25, 4=0), and the average of all items within a Dimension will be calculated. This results in 4 definitive scores at each timepoint. The average of all 23 items will be the Total Score at a given timepoint; and, 2) the repeated measures of performance status (Karnofsky score for patients > 16 years of age and Lansky score for patients ≤ 16 years of age).|3 weeks||||||
736915|NCT00436852|Secondary|Objective Response Rate|The proportion of patients who are responders will be tabulated, including a 95% confidence interval on the proportion.|Duration of protocol therapy||||||
736916|NCT00436852|Primary|1-year Progression-free Survival|PFS probabilities calculated using the Kaplan-Meier method, along 95% confidence intervals, separately for each stratum.|From the day of enrollment to the date of disease progression/recurrence , or the date of death (all causes of mortality) if disease progression/recurrence is not reached, assessed up to 1 yr. Pts were to be followed for 5 yrs after completion of therapy|The protocol-specified definition of evaluability was applied. This was not an intention-to-treat analysis because patients who did not receive study drug were excluded (inevaluable).||percent probability||95% Confidence Interval|Number
736917|NCT00436852|Primary|Median Time to Progression as Assessed by Response Evaluation Criteria in Solid Tumors|Median time to progression observed on ABT-751, along with 95% confidence intervals.|From time to enrollment to death due to any cause, assessed up to 5.1 years|The protocol-specified definition of evaluability was applied. This was not an intention-to-treat analysis because patients who did not receive study drug were excluded (inevaluable).||days||95% Confidence Interval|Median
736918|NCT00436904|Secondary|Time to Disease Progression|Calculated from date of registration to date of disease progression. In patients that have not progressed, time to disease progression will be censored at the patient's last evaluation date.|Time from registration to progression (up to 5 years)|||Months||95% Confidence Interval|Median
736919|NCT00436904|Secondary|Survival|Survival is calculated from the date of registration to the date of death due to any cause. In patients who are still alive, survival will be censored at the last date when the patient was known to be alive.|Death or last follow-up (up to 5 years)|At analysis time, only 1 out of 30 patients had died. Thus, median survival was not attainable.||Months||95% Confidence Interval|Median
736920|NCT00436904|Secondary|Duration of Response|Duration of response is calculated from the date of documented response until the date of progression in the subset of patients who respond to treatment. In patients who have not yet progressed, duration of response will be censored at the patient's last evaluation date.|Up to 5 years|Patients that responded were included in the analysis.||Months||95% Confidence Interval|Median
736921|NCT00436904|Secondary|Time to Response|Calculated from the date of registration until the first date at which the patient's objective status was classified as a response. In patients who do not achieve a response, time to response will be censored at the patient's last evaluation date. Response is defined the same way as in the response primary outcome measure.|Registration to first response (up to 5 years)|||Days||95% Confidence Interval|Median
736922|NCT00436904|Primary|Number of Participants With Treatment Related Adverse Events|"Adverse events (AE) that are classified as either possibly, probably, or definitely related to study treatment according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE version 3.0). The maximum grade for each type of AE will be recorded for each patient. Grade refers to the severity of the AE. >
> Grade 1: Mild AE, Grade 2: Moderate AE, Grade 3: Severe AE, Grade 4: Life-threatening or disabling AE, Grade 5: Death related AE"|Weekly for first 6 weeks, then monthly for 6 months, then at 9 and 12 months post registration|||participants|||Number
736923|NCT00436904|Primary|Confirmed Response, Defined as Objective Complete Remission or Partial Remission for a Duration of at Least 2 Months|Confirmed response is defined as a > 50% decrease in clinical symptoms from baseline and recovery from blood counts.|Up to 6 months|Number of patients with a confirmed response out of total patients evaluable for response.||participants||95% Confidence Interval|Number
736924|NCT00436917|Secondary|Time to Disease Progression||5 yr||||||
736925|NCT00436917|Secondary|Frequency and Severity of Toxicity as Assessed by NCI CTCAE v3.0||5 yr||||||
736926|NCT00436917|Secondary|Femoral Neck BMD as Measured by DXA at Baseline and at 12, 24, 36, 48, and 60 Months||5 yr||||||
736927|NCT00436917|Secondary|Total Lumbar Spine BMD as Measured by DXA at Baseline and at 24, 36, 48, and 60 > Months||5 yr||||||
736928|NCT00436917|Primary|Average Intra-patient Change in Total Lumbar Spine (L1 to L4) Bone Mineral Density (BMD)|Change: BMD values at twelve months post study entry minus BMD values at baseline, expressed as a percentage of the baseline value.|Baseline and 1 year|The primary analysis is performed on data where participants had the same baseline and 1 year BMD Lumbar Spine measurement location (L1-L4, L2-L4 or ‘other Lumbar Spine’)||Percentage of the baseline value||95% Confidence Interval|Mean
736929|NCT00436956|Secondary|Number of Grade 3 Toxicities|Here is the number of Grade 3 (severe) toxicities.|61.5 months|Only 58 participants were evaluable for toxicity.||toxicities|||Number
736930|NCT00436956|Secondary|Number of Grade 2 Toxicities|Here is the number of Grade 2 (moderate) toxicities.|61.5 months|Only 58 participants were evaluable for toxicity.||toxicities|||Number
736931|NCT00436956|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|61.5 months|||participants|||Number
736932|NCT00436956|Primary|Percentage of Participants With 6-month Progression-free Survival (PFS)|PFS is the proportion of subjects who progress or die by 6 months after the start of the combined therapy. PFS is determined by prostatic specific antigen (PSA) consensus criteria and the Response Evaluation Criteria in Solid Tumors (RECIST). PSA consensus criteria is defined as PSA decline of >/= 50% or PSA progression. RECIST is defined as the following: Complete response (CR) is disappearance of all target lesions; partial response (PR) is at least a 30% decline in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; and stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease ((PD) at least a 20% increase in the sum of the LD of target lesions, or the appearance of one or more lesions), taking as reference the smallest sum LD since the treatment started.|6 months|One participant was not evaluable owing to the development of a cord compression on day 2 of therapy and was subsequently removed from the trial. Since the prednisone was added to relieve toxicity & outcome data is based on response, the cohorts were analyzed together in terms of response. No suggestion prednisone significantly altered outcomes.||percentage of participants|||Number
736998|NCT00437203|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)]|AUC (0-24) = Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-24).|0(pre-dose), 0.25, 1, 3, 3.25, 3.5, 4, 6, 8, 10, 24 hr post-infusion start: Day 1, 8 Cycle 0|Data was not analyzed, as study was terminated due to business reasons.||ng*hr/mL||Standard Deviation|Geometric Mean
736955|NCT00436982|Secondary|The Objective is to Investigate the Clinical, Radiographic, Roentgen Stereophotogrammetric Behaviour and Patient Outcome in a Prospective Randomized Clinical Trial.|"Plain radiographs for disease class. Clinical assessment AKSS and KOOS score. Post operative FU all plain radiographs for assessment of the component position.
Yearly radiographic FU to assess wear, radiolucent zones and stress resorption and patella sky view projection."|3 months, 1, 2, 5, 7 and 10 years||||||
736956|NCT00436982|Primary|Roentgen Stereophotogrammetric Analysis (RSA)|To compare the maximum total point motion of the Triathlon and Duracon tibial components after two years assessed by means of RSA.|2 years|||mm||Standard Deviation|Mean
736957|NCT00437034|Secondary|Circulating Endothelial Progenitors|The change in the prevalence/expression of these markers between pre-and-post treatment samples will be analyzed by McNemar’s test. Ninety-five percent confidence intervals will be calculated to assess the precision of the obtained estimates for all laboratory correlates.|At baseline, before every course for 3 months, and then every 3 months during treatment for the first year||||||
736958|NCT00437034|Secondary|Proangiogenic Factors Such as VEGF|The change in the prevalence/expression of these markers between pre-and-post treatment samples will be analyzed by McNemar’s test. Ninety-five percent confidence intervals will be calculated to assess the precision of the obtained estimates for all laboratory correlates.|At baseline, before every course for 3 months, and then every 3 months during treatment for the first year||||||
736959|NCT00437034|Secondary|The Apoptotic State of Tumor Neovasculature|The change in the prevalence/expression of these markers between pre-and-post treatment samples will be analyzed by McNemar’s test. Ninety-five percent confidence intervals will be calculated to assess the precision of the obtained estimates for all laboratory correlates.|At baseline and post-treatment (1 week after 2nd dose and end of study)||||||
736960|NCT00437034|Secondary|Tissue Expression Patterns of VEGFR Subtypes|The change in the prevalence/expression of these markers between pre-and-post treatment samples will be analyzed by McNemar’s test. Ninety-five percent confidence intervals will be calculated to assess the precision of the obtained estimates for all laboratory correlates.|At baseline and post-treatment (1 week after 2nd dose and end of study)||||||
736961|NCT00437034|Secondary|Toxicities|Toxicities will be assessed and graded according to Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0 terminology. Exact 95% confidence intervals around the toxicity proportions will be calculated to assess the precision of the obtained estimates.|During treatment and follow up||||||
736962|NCT00437034|Secondary|Overall Survival (OS)|Assessed by Kaplan-Meier survival analysis and 95% confidence intervals will be calculated using Greenwood’s formulae.|Time from first treatment day until death, assesseduUp to 6 months||||||
736963|NCT00437034|Secondary|Progression-free Survival (PFS)|Assessed by Kaplan-Meier survival analysis and 95% confidence intervals will be calculated using Greenwood’s formulae.|Time from first treatment day until objective or symptomatic progression, assessed up to 6 months||||||
736964|NCT00437034|Primary|Overall Response Rate (Complete [CR] and Partial Response [PR])|"A 95% confidence interval was intended to be estimated via binomial proportions, but was not computed due to small sample size.
Criteria for Response from EBMT, IBMTR, ABMTR: Complete Response:Complete absence of monoclonal protein by immunofixation for a minimum of 6 weeks; Near Complete Response:Absence of serum paraprotein by standard serum/urine protein electrophoresis without disappearance of monoclonal spike by immunofixation; Partial Response:Sustained decrease in production rate of monoclonal serum protein to 50% or less of pretreatment value; Stable Disease: No significant change from baseline; Progression of Disease:Patients with a > or = 25% rise in production rate, new/increased size of lytic lesions/plasmacytomas/progressive marrow plasmacytosis; Symptomatic Deterioration:Patients with deterioration of health requiring discontinuation of treatment w/out objective evidence of disease progression."|At baseline and every 4 weeks during study treatment until treatment discontinuation due to disease progression, unacceptable toxicities and/or patient withdrawal.|||participants|||Number
736965|NCT00437073|Secondary|Percentage of Participants With a >=20% Volumetric Reduction in CNS Lesions|The percentage of participants with a >=20% volumetric reduction in CNS lesions was defined as the percentage of treated participants achieving at least a 20% volumetric reduction in CNS lesions relative to baseline. This study was closed before full enrollment was achieved; thus, predefined secondary efficacy endpoints were not assessed because there were not enough participants enrolled in the study to provide statistically valid analyses.|Baseline; from the start of treatment until disease progression, death, or discontinuation from the study, up to a maximum of Week 88|mITT Population|||||
736966|NCT00437073|Secondary|Percentage of Participants With Disease Stabilization for 6 Months or More|The percentage participants with disease stabiliztion for 6 months or more were defined as those treated participants with a best CNS objective response of SD whose disease stabilization lasted 6 months or more from the start of treatment. This study was closed before full enrollment was achieved; thus, predefined secondary efficacy endpoints were not assessed because there were not enough participants enrolled in the study to provide statistically valid analyses.|From the start of treatment until disease progression, death, or discontinuation from the study, up to a maximum of Week 88|mITT Population|||||
736967|NCT00437073|Secondary|Percentage of Participants With Baseline Tumor-related (TR) Neurological Signs and Symptoms (NSS), Who Experienced Improvement in NSS as Measured by the Neurological Examination Worksheet (NEW)|TR NSS was to be recorded by the Investigator on the NEW, using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE V3.0). Improvement was to be defined as a decrease of 1 or more CTCAE grades from baseline of any TR NSS. This study was closed before full enrollment was achieved; thus, predefined secondary efficacy endpoints were not assessed because there were not enough participants enrolled in the study to provide statistically valid analyses.|From the start of treatment until disease progression, death, or discontinuation from the study, up to a maximum of Week 88|mITT Population|||||
736968|NCT00437073|Secondary|Overall Survival|Overall survival is defined as the time from the start of treatment until death due to any cause. This study was closed before full enrollment was achieved; thus, predefined secondary efficacy endpoints were not assessed because there were not enough participants enrolled in the study to provide statistically valid analyses.|From the start of treatment until disease progression, death, or discontinuation from the study, up to a maximum of Week 88|mITT Population|||||
736969|NCT00437073|Secondary|Progression-free Survival|Progression-free survival is defined as the time from the start of treatment until the first documented sign of disease progression at any site or death due to any cause, if sooner. This study was closed before full enrollment was achieved; thus, predefined secondary efficacy endpoints were not assessed because there were not enough participants enrolled in the study to provide statistically valid analyses.|From the start of treatment until disease progression, death, or discontinuation from the study, up to a maximum of Week 88|mITT Population|||||
736970|NCT00437073|Secondary|Number of Participants With the Indicated Site of Initial Disease Progression|The site of initial disease will be determined by taking the earliest date of known progression and assigning the appropriate category (CNS or non-CNS) based on the source of the earliest date. This study was closed before full enrollment was achieved; thus, predefined secondary efficacy endpoints were not assessed because there were not enough participants enrolled in the study to provide statistically valid analyses.|From the start of treatment until disease progression, death, or discontinuation from the study, up to a maximum of Week 88|mITT Population|||||
736971|NCT00437073|Secondary|Time to CNS Objective Response (Defined as the Time From the Start of Treatment Until the First Documented Evidence of Partial or Complete Tumor Response [Whichever Status is Recorded First])|CNS OR is defined as the number of participants with either a CR or PR as assessed by volumetric analysis of brain MRI and RECIST. CR: complete resolution of all evaluable and non-evaluable brain metastases; PR: =>50% reduction in the volumetric sum of all evaluable brain metastases compared to baseline. This study was closed before full enrollment was achieved; thus, predefined secondary efficacy endpoints were not assessed because there were not enough participants enrolled in the study to provide statistically valid analyses.|From the start of treatment until disease progression, death, or discontinuation from the study, up to a maximum of Week 88|mITT Population|||||
736972|NCT00437073|Secondary|Percentage of Participants (Par.) With Objective Response by RECIST in Non-CNS Disease|Non-CNS disease (for par. with measurable baseline non-CNS disease) OR is defined as the number of par. with either a CR or PR as assessed by computed tomography (CT) or MRI scan and RECIST. CR: disappearance of all target lesions; PR: at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. This study was closed before full enrollment was achieved; thus, predefined secondary efficacy endpoints were not assessed because there were not enough par. enrolled in the study to provide statistically valid analyses.|From the start of treatment until disease progression, death, or discontinuation from the study, up to a maximum of Week 88|mITT Population|||||
736973|NCT00437073|Secondary|Percentage of Participants With Clinical Benefit|Clinical benefit is defined as CR (complete resolution of all evaluable and non-evaluable brain metastases), PR (=>50% reduction in the volumetric sum of all evaluable brain metastases compared to baseline), or stable disease (disease that does not meet CR, PR, or CNS progression criteria) for at least 6 months. This study was closed before full enrollment was achieved; thus, predefined secondary efficacy endpoints were not assessed because there were not enough participants enrolled in the study to provide statistically valid analyses.|From the start of treatment until disease progression, death, or discontinuation from the study, up to a maximum of Week 88|mITT Population|||||
736974|NCT00437073|Secondary|Duration of CNS Objective Response (Defined as the Time From the First Documented Evidence of CNS PR or CR Until the First Documented Sign of Disease Progression or Death, if Sooner)|CNS OR is defined as the number of participants with either a CR or PR as assessed by volumetric analysis of brain MRI and RECIST. CR: complete resolution of all evaluable and non-evaluable brain metastases; PR: =>50% reduction in the volumetric sum of all evaluable brain metastases compared to baseline. This study was closed before full enrollment was achieved; thus, predefined secondary efficacy endpoints were not assessed because there were not enough participants enrolled in the study to provide statistically valid analyses.|From the start of treatment until disease progression, death, or discontinuation from the study, up to a maximum of Week 88|mITT Population|||||
736975|NCT00437073|Primary|Number of Participants With the Indicated CNS Responses|"CNS responses were assessed by volumetric (V) analysis of brain MRI and RECIST. CR: complete resolution of all evaluable and non-evaluable brain metastases (BMs). PR: =>50% reduction in the V sum of all evaluable BMs compared to baseline. A response of Other was used for participants who discontinued the study prior to the first efficacy assessment. Stable Disease (SD): disease that does not meet CR, PR, or CNS progression criteria. Progressive disease (PD): a requirement for a new steroid or an increasing steroid dose for the treatment of worsening neurological signs/symptoms due to BMs."|From the start of treatment until disease progression, death, or discontinuation from the study, up to a maximum of Week 88|mITT Population||participants|||Number
736976|NCT00437073|Primary|Number of Participants With the Indicated Central Nervous System (CNS) Objective Response (OR)|CNS OR is defined as the number of participants with either a complete response (CR) or partial response (PR) as assessed by volumetric analysis of brain magnetic resonance imaging (MRI) and Response Evaluation Criteria In Solid Tumors (RECIST). CR: complete resolution of all evaluable and non-evaluable brain metastases; PR: =>50% reduction in the volumetric sum of all evaluable brain metastases compared to baseline.|From the start of treatment until disease progression, death, or discontinuation from the study, up to a maximum of Week 88|Modified Intent-to-Treat (mITT) Population: all participants who had at least one evaluable CNS target lesion at baseline and who had received at least two doses of lapatinib medication||participants|||Number
736977|NCT00437125|Secondary|Number of Participants Who Reached Remission by 12 Weeks|Remission was defined as reaching a 17-item Hamilton Depression Rating Scale (HAMD) total score <=7. The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).|12 weeks|All treated participants for whom both baseline data and post-baseline data for at least 1 visit for at least one efficacy variable were available (Full analysis set population) were included in the analyses. Last observation carried forward analysis.||participants|||Number
736978|NCT00437125|Secondary|Number of Participants Who Responded to Treatment by 12 Weeks|Response was defined as a >= 50% reduction in 17-item Hamilton Depression rating scale (HAMD) scores. The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).|12 weeks|All treated participants for whom both baseline data and post-baseline data for at least 1 visit for at least one efficacy variable were available (Full analysis set population) were included in the analyses. Last observation carried forward analysis.||participants|||Number
736979|NCT00437125|Secondary|Laboratory Analytes|Laboratory analytes were collected to assess adverse events which are listed in the reported adverse events section.|baseline through 12 weeks|All enrolled participants for whom both baseline data and post-baseline data were available were included in the analyses.||participants|||Number
736980|NCT00437125|Secondary|Number of Participants With Abnormal Electrocardiograms (ECG) During the 12 Week Study|Included were participants with normal ECG at baseline who developed abnormal ECGs during the study.|baseline through 12 weeks|All treated participants were included in the analysis population. 54 participants were excluded from calculation of change as they had abnormal ECG at baseline, no baseline measure, or no post-baseline measure.||participants|||Number
736981|NCT00437125|Secondary|Average Change From Baseline to 12 Weeks in Heart Rate|For each participant, changes across individual visits were averaged to obtain 1 measurement per participant.|baseline through 12 weeks|All treated participants were included in the analysis population. 6 participants were excluded from calculation of change as they had either no baseline or post-baseline measure.||beats per minute||95% Confidence Interval|Mean
736982|NCT00437125|Secondary|Average Change From Baseline to 12 Weeks in Blood Pressure|For each participant, changes across individual visits were averaged to obtain 1 measurement per participant.|baseline through 12 weeks|All treated participants were included in the analysis population. 5 participants for standing measurement and 6 participants for supine measurements were excluded from calculation of change as they had either no baseline or no post-baseline measure.||millimeter mercury||95% Confidence Interval|Mean
736983|NCT00437125|Secondary|Change From Baseline to 12 Weeks in Parkinson Disease Questionnaire - 39 Item Version (PDQ-39) Total Score|The PDQ-39 has 39 items. Higher scores reflect lower quality of life. The PDQ-39 has eight subscales: mobility (10 items), activities of daily living (six items), emotional wellbeing (six items), stigma (four items), social support (three items), cognition (four items), communication (three items), and bodily discomfort (three items). Items in each subscale, as well in the total scale, can be summarized into an index and transformed linearly to a 0-100 scale.|baseline, 12 weeks|All treated participants with both baseline data and post-baseline data for at least 1 visit for at least 1 efficacy variable were available (Full analysis set population) were included in the analyses. Last observation carried forward analysis. Excluded were 2 participants with no baseline measure and 29 participants with no post baseline measure.||units on a scale||Standard Deviation|Mean
736984|NCT00437125|Secondary|Change From Baseline to 12 Weeks in Visual Analog Scale (VAS)|VAS for pain consists of 6 questions that assess overall pain, headache, back pain, shoulder pain, pain interference with daily activities, and pain while awake. Participant rates pain on a 100 millimeter (mm) line between two anchors (0= no pain and 100=very severe pain). Here, the line was only 93 mm long due to an error on the clinical research form and scores were adjusted to 0 to 93.|baseline, 12 weeks|All treated participants for whom both baseline data and post-baseline data for at least 1 visit for at least 1 efficacy variable were available (Full analysis set population) were included in the analyses. Last observation carried forward analysis. Excluded were 2 participants with only post-baseline data and 1 participant with only baseline data.||units on a scale||Standard Deviation|Mean
736985|NCT00437125|Secondary|Change From Baseline to 12 Weeks in Beck Depression Inventory (BDI) Total Score|A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.|baseline, 12 weeks|All treated participants for whom both baseline data and post-baseline data for at least 1 visit for at least one efficacy variable were available (Full analysis set population) were included in the analyses. Last observation carried forward analysis. 27 participants had no post baseline measure.||units on a scale||Standard Deviation|Mean
736986|NCT00437125|Secondary|Patient's Global Impression-Improvement at Week 12|A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. Scoring: 1=very much better; 2=much better; 3=low better; 4=no change; 5=low worse; 6=much worse; 7=very much worse.|12 weeks|All treated participants for whom both baseline data and post-baseline data for at least 1 visit for at least one efficacy variable were available (Full analysis set population) were included in the analyses.||participants|||Number
736987|NCT00437125|Secondary|Change From Baseline to 12 Weeks on the Clinical Global Impression-Severity Scale|Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|baseline, 12 weeks|All treated participants for whom both baseline data and post-baseline data for at least 1 visit for at least one efficacy variable were available (Full analysis set population) were included in the analyses. Last observation carried forward analysis.||units on a scale||Standard Deviation|Mean
736988|NCT00437125|Secondary|Change From Baseline to 12 Weeks on the 17-item Hamilton Depression Rating Scale (HAMD-17) Total Score|The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).|baseline, 12 weeks|All treated participants for whom both baseline data and post-baseline data for at least 1 visit for at least one efficacy variable were available (Full analysis set population) were included in the analyses. Last observation carried forward analysis.||units on a scale||Standard Deviation|Mean
736989|NCT00437125|Secondary|Change From Baseline on the Pittsburgh Sleep Quality Index (PSQI)|Self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. 19 individual items generate seven “component” scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The subject self-rates each of these seven areas of sleep. Scoring of answers is based on a 0 to 3 scale, whereby 3 reflects the negative extreme on the Likert Scale. The total score is the sum of the 7 component scores (total score range: 0-21).|baseline, 4 weeks, 8 weeks, 12 weeks|All treated participants with baseline and post-baseline data for >= 1 visit for >= 1 efficacy variable were included in the analyses (Full Analysis Set population). Last observation carried forward analysis. Excluded 2 participants (no baseline measure of PSQI) and 13 participants from calculation of change (absence of any post-baseline measure).||units on a scale||Standard Deviation|Mean
736990|NCT00437125|Secondary|Change From Baseline to 12 Weeks on the UKU (Udvalg for Kliniske Undersogelser: Committee for Clinical Investigations) Side Effect Rating Scale|Clinician-rated scale, providing side effect ratings of psychopharmacological medications. 48 items, each item is rated on a 4-point scale (0=not present; 1=mild; 2=moderate; 3=severe). The test is divided in 6 subscales, total scores for each subscale are calculated based on a weighted secondary scoring system. Subscales: psychic (score range:0-30), neurological (score range:0-24), autonomic (score range:0-33), other (score range:0-75), global assesment by subject (score range:0-3), and global assessment by doctor (score range:0-3). Higher ratings indicate greater impairment.|baseline, 12 weeks|All treated participants were included in the analysis population. Last observation carried forward analysis. One participant was excluded as no data for UKU were available and other participants were excluded as relevant due to absence of either baseline or post-baseline measure.||units on a scale||Standard Deviation|Mean
736991|NCT00437125|Secondary|Change From Baseline to 12 Weeks on the Unified Parkinson's Disease Rating Scale (UPDRS) Total Score|Rating tool to follow the longitudinal course of Parkinson's Disease. It is composed of Section I: Mentation, Behavior, and Mood; Section II: Activities of Daily Living; Section III: Motor Examination; Section IV: Complications of therapy. These are evaluated by interview. Some sections require that multiple grades be assigned to each extremity. Only Sections II and III were rated in this study. A total of 160 points are possible (52 in Section II and 108 in Section III), where 0 represents no disability and 160 indicates maximal grade of disability.|baseline, 12 weeks|All treated participants were included in the analysis population. Last observation carried forward analysis. Two participants were excluded from calculation of change as they had no post-baseline measure.||units on a scale||Standard Deviation|Mean
736992|NCT00437125|Primary|Number of Participants Reporting Serious Adverse Events or Other Adverse Events Leading Either to Discontinuation or to Death|The results reported are the number of participants who discontinued the study as a result of an adverse event (serious or other) or death.|baseline through 12 weeks|All treated participants.||participants|||Number
736993|NCT00437203|Secondary|Metabolite Profile of PF-00477736 in Plasma and Urine||0(pre-dose), 0.25, 1, 3, 3.25, 3.5, 4, 6, 8, 10, 24 hr post-infusion start:Day 1, 8 Cycle 0 Cohort 1-3; 0(pre-dose), 0.25, 1, 2, 24, 24.25, 24.5, 25, 27, 29, 31, 48 hr post-infusion start:Day 1-2, 8-9 Cycle 0 Cohort 4-8; Day 2-3, 9-10 Cycle 1 Cohort 9-10|Data was not analyzed, as study was terminated due to business reasons.||percentage of recovered metabolite|||Number
736994|NCT00437203|Secondary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0(pre-dose), 0.25, 1, 3, 3.25, 3.5, 4, 6, 8, 10, 24 hr post-infusion start:Day 1, 8 Cycle 0 Cohort 1-3; 0(pre-dose), 0.25, 1, 2, 24, 24.25, 24.5, 25, 27, 29, 31, 48 hr post-infusion start:Day 1-2, 8-9 Cycle 0 Cohort 4-8; Day 2-3, 9-10 Cycle 1 Cohort 9-10|Data was not analyzed, as study was terminated due to business reasons.||hr||Standard Deviation|Mean
736995|NCT00437203|Secondary|Concentration of PF-00477736 in Urine||0(pre-dose), 0.25, 1, 3, 3.25, 3.5, 4, 6, 8, 10, 24 hr post-infusion start:Day 1, 8 Cycle 0 Cohort 1-3; 0(pre-dose), 0.25, 1, 2, 24, 24.25, 24.5, 25, 27, 29, 31, 48 hr post-infusion start:Day 1-2, 8-9 Cycle 0 Cohort 4-8; Day 2-3, 9-10 Cycle 1 Cohort 9-10|Data was not analyzed, as study was terminated due to business reasons.||ng/mL||Standard Deviation|Geometric Mean
736996|NCT00437203|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).|0(pre-dose), 0.25, 1, 3, 3.25, 3.5, 4, 6, 8, 10, 24 hr post-infusion start:Day 1, 8 Cycle 0 Cohort 1-3; 0(pre-dose), 0.25, 1, 2, 24, 24.25, 24.5, 25, 27, 29, 31, 48 hr post-infusion start:Day 1-2, 8-9 Cycle 0 Cohort 4-8; Day 2-3, 9-10 Cycle 1 Cohort 9-10|Data was not analyzed, as study was terminated due to business reasons.||ng*hr/mL||Standard Deviation|Geometric Mean
736997|NCT00437203|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-48)]|AUC (0-48)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-48).|0(pre-dose), 0.25, 1, 2, 24, 24.25, 24.5, 25, 27, 29, 31, 48 hr post-infusion start:Day 1-2, 8-9 Cycle 0 Cohort 4-8; Day 2-3, 9-10 Cycle 1 Cohort 9-10|Data was not analyzed, as study was terminated due to business reasons.||ng*hr/mL||Standard Deviation|Geometric Mean
737286|NCT00448630|Primary|Metabolic Syndrome Parameter Body Mass Index (BMI)|Iterative mean Body Mass Index at time points.|Baseline, 1 Month, 4 Months|Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.||kg/m*m (kilograms per meter squared)||Standard Deviation|Mean
736999|NCT00437203|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0(pre-dose), 0.25, 1, 3, 3.25, 3.5, 4, 6, 8, 10, 24 hr post-infusion start:Day 1, 8 Cycle 0 Cohort 1-3; 0(pre-dose), 0.25, 1, 2, 24, 24.25, 24.5, 25, 27, 29, 31, 48 hr post-infusion start:Day 1-2, 8-9 Cycle 0 Cohort 4-8; Day 2-3, 9-10 Cycle 1 Cohort 9-10|Data was not analyzed, as study was terminated due to business reasons.||hr||Full Range|Median
737000|NCT00437203|Secondary|Minimum Observed Plasma Trough Concentration (Cmin)||0(pre-dose), 0.25, 1, 3, 3.25, 3.5, 4, 6, 8, 10, 24 hr post-infusion start:Day 1, 8 Cycle 0 Cohort 1-3; 0(pre-dose), 0.25, 1, 2, 24, 24.25, 24.5, 25, 27, 29, 31, 48 hr post-infusion start:Day 1-2, 8-9 Cycle 0 Cohort 4-8; Day 2-3, 9-10 Cycle 1 Cohort 9-10|Data was not analyzed, as study was terminated due to business reasons.||ng/mL||Standard Deviation|Geometric Mean
737001|NCT00437203|Secondary|Maximum Observed Plasma Concentration (Cmax)||0(pre-dose), 0.25, 1, 3, 3.25, 3.5, 4, 6, 8, 10, 24 hr post-infusion start:Day 1, 8 Cycle 0 Cohort 1-3; 0(pre-dose), 0.25, 1, 2, 24, 24.25, 24.5, 25, 27, 29, 31, 48 hr post-infusion start:Day 1-2, 8-9 Cycle 0 Cohort 4-8; Day 2-3, 9-10 Cycle 1 Cohort 9-10|Data was not analyzed, as study was terminated due to business reasons.||ng/mL||Standard Deviation|Geometric Mean
737002|NCT00437203|Secondary|Number of Participants With Objective Response (OR)|OR based assessment of confirmed complete response(CR)/confirmed partial response(PR)/stable disease(SD)/progressive disease(PD) as per Response Evaluation Criteria in Solid Tumors(RECIST).CR:disappearance of target lesions;PR:at least(>=) 30% decrease in sum of longest dimensions of target lesions(reference:baseline sum of longest dimensions);PD:>=20% increase in sum of longest dimensions of target lesions(reference:smallest sum of longest dimensions recorded since treatment started)/appearance of any new lesions;SD:no adequate shrinkage to qualify for PR/adequate increase to qualify for PD.|Baseline, Day 15 of Cycle 2 and 4 and every 4 cycles thereafter up to Week 62|FAS included all enrolled participants who received at least 1 dose of study medication.||participants|||Number
737003|NCT00437203|Primary|Maximum Tolerated Dose (MTD) of PF-00477736 When Administered in Combination With Gemcitabine||Up to Day 21 Cycle 1|Full analysis set (FAS) included all enrolled participants who received at least 1 dose of study medication.||mg|||Number
737004|NCT00437281|Primary|Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment|Analysis for severity of AEs was performed separately for double-blind and open-label treatment. AE = any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. AEs were classified as mild, moderate and severe based on severity assessment: Mild = no interference with participant's usual function; Moderate = some interference with participant's usual function; Severe = significant interference with participant's usual function. Treatment-emergent events for open-label treatment included events between Day 8 and 28 days after the open-label dose that were absent before treatment or that worsened relative to pretreatment state. Participants may experience more than 1 AE.|Day 8 up to 28 days after open-label dose of study medication|Safety analysis set included all participants who received at least 1 dose of study medication.||adverse events|||Number
737005|NCT00437281|Secondary|Renal Clearance (CLr): Single-Dose Analysis|Renal clearance is the volume of plasma from which the drug is completely removed by the kidney in a given amount of time. CLr for participants who received matching placebo from Day 1 to Day 7 and pregabalin on Day 8 morning was to be reported (single-dose participants).|0 to 12 hours post-dose, 12 to 24 hours post-dose on Day 8|PK parameter analysis population. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Results are only reported for pregabalin 15 mg/kg/day, 7 to 11 years and pregabalin 5 mg/kg/day, 12 to 16 years because none of the participant had PK parameter available in rest of the groups.||mL/min||Geometric Coefficient of Variation|Geometric Mean
737006|NCT00437281|Secondary|Renal Clearance (CLr): Multiple-Dose Analysis|Renal clearance is the volume of plasma from which the drug is completely removed by the kidney in a given amount of time. CLr for participants who received pregabalin from Day 1 to Day 8 morning is reported (multiple-dose participants).|0 to 12 hours post-dose, 12 to 24 hours post-dose on Day 8|PK parameter analysis population. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Results are not reported for some of the groups since none of the participant had PK parameter available in these groups.||mL/min||Geometric Coefficient of Variation|Geometric Mean
737007|NCT00437281|Secondary|Apparent Oral Clearance (CL/F): Single-Dose Analysis|Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed (F). Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. CL/F for participants who received matching placebo from Day 1 to Day 7 and pregabalin on Day 8 morning is reported (single-dose participants).|Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8|PK parameter analysis population. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Results are not reported for pregabalin 10 and 15 mg/kg/day for 12 to 16 age cohort since none of the participant had PK parameter available in these groups.||mL/min||Geometric Coefficient of Variation|Geometric Mean
737008|NCT00437281|Secondary|Apparent Oral Clearance (CL/F): Multiple-Dose Analysis|Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed (F). Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. CL/F for participants who received pregabalin from Day 1 to Day 8 morning is reported (multiple-dose participants).|Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period (double-blind or open label treatment). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||milliliter/minute (mL/min)||Geometric Coefficient of Variation|Geometric Mean
737009|NCT00437281|Secondary|Plasma Decay Half-Life (t1/2): Single-Dose Analysis|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. t1/2 for participants who received matching placebo from Day 1 to Day 7 and pregabalin on Day 8 morning is reported (single-dose participants).|Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8|PK parameter analysis population. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Results are not reported for pregabalin 10 and 15 mg/kg/day for 12 to 16 age cohort since none of the participant had PK parameter available in these groups.||hours||Standard Deviation|Mean
737010|NCT00437281|Secondary|Plasma Decay Half-Life (t1/2): Multiple-Dose Analysis|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. t1/2 for participants who received pregabalin from Day 1 to Day 8 morning is reported (multiple-dose participants).|Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period (double-blind or open label treatment). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||hours||Standard Deviation|Mean
737011|NCT00437281|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax): Single-Dose Analysis|Tmax for participants who received matching placebo from Day 1 to Day 7 and pregabalin on Day 8 morning is reported (single-dose participants).|Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8|PK parameter analysis population. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Results are not reported for pregabalin 10 and 15 mg/kg/day for 12 to 16 age cohort since none of the participant had PK parameter available in these groups.||hours||Full Range|Median
737012|NCT00437281|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax): Multiple-Dose Analysis|Tmax for participants who received pregabalin from Day 1 to Day 8 morning is reported (multiple-dose participants).|Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period (double-blind or open label treatment). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||hours||Full Range|Median
737013|NCT00437281|Secondary|Maximum Observed Plasma Concentration (Cmax): Single-Dose Analysis|Cmax for participants who received matching placebo from Day 1 to Day 7 and pregabalin on Day 8 morning is reported (single-dose participants). Results are normalized to individual participant's Day 8 dose.|Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8|PK parameter analysis population. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Results are not reported for pregabalin 10 and 15 mg/kg/day for 12 to 16 age cohort since none of the participant had PK parameter available in these groups.||(microgram/milliliter)/(mg/kg)||Geometric Coefficient of Variation|Geometric Mean
737014|NCT00437281|Secondary|Maximum Observed Plasma Concentration (Cmax): Multiple-Dose Analysis|Cmax for participants who received pregabalin from Day 1 to Day 8 morning is reported (multiple-dose participants). Results are normalized to individual participant's Day 8 dose.|Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period (double-blind or open label treatment). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||(microgram/milliliter)/(mg/kg)||Geometric Coefficient of Variation|Geometric Mean
737015|NCT00437281|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]: Single-Dose Analysis|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). AUC (0 - ∞) for participants who received matching placebo from Day 1 to Day 7 and pregabalin on Day 8 morning is reported (single-dose participants). Results are normalized to individual participant's Day 8 dose.|Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8|PK parameter analysis population. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Results are not reported for pregabalin 10 and 15 mg/kg/day for 12 to 16 age cohort since none of the participant had PK parameter available in these groups.||(microgram*hour/milliliter)/(mg/kg)||Geometric Coefficient of Variation|Geometric Mean
737016|NCT00437281|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau): Multiple-Dose Analysis|Area under the curve from time zero to the end of dosing interval (AUCtau), where dosing interval was 12 hours, for participants who received pregabalin from Day 1 to Day 8 morning is reported (multiple-dose participants). Results are normalized to individual participant's Day 8 dose.|Pre-dose, 0.5, 1, 2, 4, 8, 12 hours post-dose on Day 8|Pharmacokinetic (PK) parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period (double-blind or open label treatment). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||(microgram*hour/milliliter)/(mg/kg)||Geometric Coefficient of Variation|Geometric Mean
737017|NCT00437281|Secondary|28-Day Seizure Frequency Rate|Seizure frequency was reported by participant's parent or guardian from randomization to 7 days post-last dose of study medication. 28-day seizure frequency rate = (number of seizures in observation period/number of days in observation period)*28.|Baseline up to 7 days post-last dose of study medication|Results are not reported since the data was reported in individual participant listings but not summarized for analysis.|||||
737018|NCT00437281|Primary|Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment|Analysis for severity of AEs was performed separately for double-blind and open-label treatment. AE = any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. AEs were classified as mild, moderate and severe based on severity assessment: Mild = no interference with participant's usual function; Moderate = some interference with participant's usual function; Severe = significant interference with participant's usual function. Treatment-emergent events for double-blind treatment included events between baseline and Day 7 that were absent before treatment or that worsened relative to pretreatment state. Participants may experience more than 1 AE.|Baseline to Day 7|Safety analysis set included all participants who received at least 1 dose of study medication.||adverse events|||Number
737019|NCT00437281|Secondary|Number of Participants With Clinically Significant Change in Physical and Neurological Findings|Full physical examination included examination of the abdomen, breasts, lungs, lymph nodes, mouth, genitourinary, musculoskeletal and neurological systems, skin, extremities, head, heart, ears, eyes, neck, nose, ocular fundi, throat and thyroid gland. The neurological exam was performed by a pediatric neurologist or qualified investigator.|Baseline up to 7 days post-last dose of study medication|Safety analysis set included all participants who received at least 1 dose of study medication.||participants|||Number
737020|NCT00437398|Secondary|Mean Glycated Hemoglobin (HbA1c) Since Transplant|HbA1c is a lab test that shows the average level of blood sugar (glucose) over the previous 3 months. It shows how well the subject is controlling his/her diabetes.|3, 6, 9, and 12 months since islet transplantation|The sample size (n=2) was too small to perform a meaningful analysis; therefore the data were not analyzed due to study termination.|||||
737021|NCT00437398|Primary|Mean Number of Hypoglycemic Events After Transplant|Hypoglycemia is an abnormally diminished content of glucose in the blood.|3, 6, 9, and 12 months since islet transplantation|The sample size (n=2) was too small to perform a meaningful analysis; therefore the data were not analyzed due to study termination.|||||
737022|NCT00437489|Secondary|Hypoglycemia Event Rate Per Month|Monthly event rate was calculated as the daily event rate multiplied by 30, and the daily event rate was calculated as the total number of events divided by the days in study up to the specified timepoint (ie, Week 4 or Week 16).|up to week 4 or 16|FAS Population||event rate per month||Standard Deviation|Mean
737023|NCT00437489|Secondary|Number of Subjects Who Experienced Hypoglycemia and Nocturnal Hypoglycemia|Cumulative Number Subjects Who Experienced Hypoglycemia & Nocturnal Hypoglycemia. Hypoglycemia:1)Clinical picture includes prompt resolution with food intake, subcutaneous glucagon, or intravenous glucose, 2)blood glucose check showing glucose <3.27 mmol/L (59 mg/dl), 3)glucose measurement of 2.7 mmol/L (49 mg/dl) or less, with or without symptoms.|week 16|FAS Population - Descriptive statistics were produced using LOCF for Week 16, therefore all subjects are included in the Week 16 data.||participants|||Number
737024|NCT00437489|Primary|Change in HbA1c From Baseline|Mean change of hemoglobin A1c (HbA1c %) from baseline to week 16|From baseline to week 16|Full analysis set (FAS) population - descriptive statistics were produced using last observation carried forward (LOCF) for Week 16, therefore all subjects are included in the Week 16 data.||Percent||Standard Deviation|Mean
737025|NCT00437489|Secondary|Fasting Plasma Glucose, and Overall Absolute, Pre-meal, and Post-meal Blood Glucose Change From Baseline to Week 16 (LOCF)|Mean change of fasting plasma glucose, and overall absolute (based on the mean of 7-point home blood glucose monitoring (HGM) values), pre- and post-meal blood glucose (based on the mean of pre- or post-meal HGM values). Change from pre- to post-meal blood glucose based on the mean of difference of pre-meal HGM values from post-meal HGM values.|From baseline to week 16|FAS - descriptive statistics were produced using LOCF for Week 16, therefore all subjects are included in the Week 16 data.||mmol/l||Standard Deviation|Mean
737026|NCT00437645|Secondary|Percentage of Patients Achieving a Systolic Response at Weeks 4, 8, and 12|Systolic response was defined as msSBP < 130 mmHg or at least a 20 mmHg reduction from baseline in msSBP at Weeks 4, 8, and 12. Blood pressure (BP) was measured at trough (24±3 hours post-dose). The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position with the back supported and both feet placed on the floor for 5 minutes, systolic and diastolic BP were measured 3 times with an automated BP monitor and appropriate size cuff. Means of the 3 measurements were calculated.|Baseline to Weeks 4, 8, and 12|Intent-to-treat (ITT) population: All randomized patients who had a baseline and at least one post-baseline efficacy assessment. For patients who discontinued prior to Week 8, the last post-baseline msSBP measurement collected was used for the analysis (last observation carried forward [LOCF]).||Percentage of patients|||Number
737027|NCT00437645|Secondary|Change in Mean Sitting Systolic and Diastolic Blood Pressure (msSBP, msDBP) From Baseline to Weeks 4, 8, and 12|Blood pressure (BP) was measured at trough (24±3 hours post-dose). The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. If there was < 0. 5 mmHg difference in BP between the 2 arms, the non-dominant arm was used. At each visit, after the patient was in a sitting position with the back supported and both feet placed on the floor for 5 minutes, systolic and diastolic BP were measured 3 times with an automated BP monitor and appropriate size cuff. Means of the 3 measurements were calculated. A negative change indicates lowered BP.|Baseline to Weeks 4, 8, and 12|Intent-to-treat (ITT) population: All randomized patients who had a baseline and at least one post-baseline efficacy assessment. For patients who discontinued prior to Week 8, the last post-baseline msSBP measurement collected was used for the analysis (last observation carried forward [LOCF]).||mmHg||Standard Error|Least Squares Mean
737028|NCT00437645|Secondary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to Week 8|Blood pressure (BP) was measured at trough (24±3 hours post-dose). The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. If there was < 0. 5 mmHg difference in BP between the 2 arms, the non-dominant arm was used. At each visit, after the patient was in a sitting position with the back supported and both feet placed on the floor for 5 minutes, systolic and diastolic BP were measured 3 times with an automated BP monitor and appropriate size cuff. Means of the 3 measurements were calculated. A negative change indicates lowered BP.|Baseline to Week 8|Intent-to-treat (ITT) population: All randomized patients who had a baseline and at least one post-baseline efficacy assessment. For patients who discontinued prior to Week 8, the last post-baseline msSBP measurement collected was used for the analysis (last observation carried forward [LOCF]).||mmHg||Standard Error|Least Squares Mean
737029|NCT00437645|Primary|Percentage of Patients With Peripheral Edema From Baseline to Week 8|Only occurrences of peripheral edema quantified as a reported adverse event coded as peripheral edema were included in the analysis. If a patient experienced more than one occurrence of peripheral edema between Day 1 and Week 8, it was only counted once in the analysis.|Baseline to Week 8|Safety population: All randomized patients.||Percentage of patients|||Number
737030|NCT00437645|Primary|Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to Week 8|Blood pressure (BP) was measured at trough (24±3 hours post-dose). The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. If there was < 0. 5 mmHg difference in BP between the 2 arms, the non-dominant arm was used. At each visit, after the patient was in a sitting position with the back supported and both feet placed on the floor for 5 minutes, systolic and diastolic BP were measured 3 times with an automated BP monitor and appropriate size cuff. Means of the 3 measurements were calculated. A negative change indicates lowered BP.|Baseline to Week 8|Intent-to-treat (ITT) population: All randomized patients who had a baseline and at least one post-baseline efficacy assessment. For patients who discontinued prior to Week 8, the last post-baseline msSBP measurement collected was used for the analysis (last observation carried forward [LOCF]).||mmHg||Standard Error|Least Squares Mean
737031|NCT00443872|Secondary|Mini Mental State Examination (MMSE) Scores for All Subjects|The MMSE is a general measure of cognition (i.e., measures attention, memory, visuospatial construction, etc). It has 30 items, each item representing 1 point. The total score ranges from 0-30 with 30 being a perfect score (no cognitive impairment) and 0 being the lowest score (greatest possible level of impairment). The total score is calculated by adding the scores of each item.|Baseline and 3 months|All||units on a scale||Standard Deviation|Mean
737032|NCT00443872|Secondary|Beck Anxiety Inventory Scores for All Subjects|The Beck Anxiety Inventory is a general measure of anxiety. There are 21 questions each with responses ranging from 0 (no issue or problem) to 3 (severe - I could barely stand it), all questions are related to the presence of signs or symptoms of anxiety. The total possible score is 63 and a higher score represents greater anxiety. The total score is calculated by adding the responses for each of the 21 items.|Baseline and 3 months|All||units on a scale||Standard Deviation|Mean
737033|NCT00443872|Secondary|Beck Depression Inventory for All Subjects|The Beck Depression Inventory is a general measure of depression. There are 21 questions each with responses ranging from 0 (no issue or problem) to 3 (maximum issue/distress), all questions are related to emotions, mood, feelings, etc. The total possible score is 63 (higher scores represent more depression). The total score is calculated by adding the scores of the 21 items.|Baseline and 3 months|All||units on a scale||Standard Deviation|Mean
737034|NCT00443872|Secondary|PDQ-39 Quality of Life Assessment Total Scores|The PDQ-39 is a measure of quality of life, it has 8 sub scales and a total score. For this study only the total score was examined. There are a total of 39 questions related to the following 8 sub scales: ability/difficulty to perform motor activities, ability to perform daily activities, cognition, emotional well being, stigma, social support, communication, bodily discomfort; each question with 5 responses (0, no/never, 4 always). The total score is calculated by adding the scores for each of the 39 items, dividing by 39 x 4 (maximum score for all 39 items) and then multiplying by 100 to get a percentage score ranging from 0-100 with 100 representing the most disability and greatest impact on quality of life.|Baseline and 3 months|||units on a scale||Standard Deviation|Mean
737035|NCT00443872|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) Scores|"The UPDRS activities of daily living sub scale has 14 questions regarding the ability to perform daily activities like dressing, eating, etc. These questions are completed by the patient and each question has 5 responses ranging from 0 (no problems) to 4 (severe disability/cannot do). The total score for this sub scale is the sum of the scores for the 14 questions (higher scores represent greater disability), maximum score is 56.
The motor assessment is completed by the investigator. There are 14 questions evaluating motor function in various body parts, representing 27 individual items (i.e., some questions, such as rigidity, are rated for 5 different body parts, other questions, such as finger tapping, are rated on both the right and left sides, and other questions are rated individually). Each item has 5 responses, 0 being none/no disability and 4 being the most severe disability. The 27 items are summed (higher scores represent greater disability); maximum score is 108."|Baseline and 3 months|All subjects completing the study were included||units on a scale||Standard Deviation|Mean
737036|NCT00443872|Primary|Barratt Impulsiveness Scale Score for Those With Impulsive Behavior|This is a measure of impulsiveness. There are 30 questions regarding the presence of impulsive and non-impulsive behaviors each scored from 1 (rarely/never) to 4 (almost always/always). The total score reflects the sum of the 30 items. A higher score represents more impulsiveness.|Baseline and 3 months|The number with ICDs at baseline||units on a scale||Standard Deviation|Mean
737037|NCT00443872|Primary|Circumference of Lower Leg/Foot at Greatest Point of Swelling for Pedal Edema|The circumference of the lower leg/ankle with the greatest swelling was measured using a standard tape measure at baseline and 12 weeks for both the right and left ankles.|Baseline and 3 months|Presence of pedal edema at baseline||centimeters||Standard Deviation|Mean
737038|NCT00443872|Primary|Neuropsychiatric Inventory (NPI) Hallucinations Scale Score for Those With Hallucinations|Report of hallucinations with insight maintained based on the hallucinations questions of the Neuropsychiatric Inventory (NPI). The participant and their caregiver are asked a series of questions to determine if hallucinations are present. If present they rate the frequency of hallucinations on a scale of 1 (rarely, less than once a week) to 4, very often (once or more daily). They also rate the severity of the hallucinations, as mild (1 - present but harmless and cause little distress), moderate (2 - distressing and disruptive) or severe (3 - very disruptive, major source of behavioral disturbance, may need meds). The frequency and severity scores are multiplied (maximum score 12, with higher scores representing more distress/disability) for the total score.|Baseline and 3 months|Patients who reported hallucinations at baseline||units on a scale||Standard Deviation|Mean
737039|NCT00443872|Primary|Epworth Sleepiness Scale Score for Those With Daytime Sleepiness|This is a measure of daytime sleepiness. The test is a list of eight situations in which one rates their tendency to become sleepy on a scale of 0, no change of dozing to 3, high chance of dozing. The total score ranges fro 0-24, with higher values representing excessive sleepiness. A score of greater than 10 represents clinically significant sleepiness.|Baseline and 3 months|Based only on the number of patients with excessive daytime sleepiness at baseline||units on a scale||Standard Deviation|Mean
737040|NCT00443872|Primary|Percentage of Participants With Reduction in Adverse Events|The primary outcome measure was the reduction of daytime sleepiness, hallucinations, pedal edema, and impulse control disorders after a reduction of dopamine agonist dose with the addition of an monoamine oxidase (MAO)-B inhibitor (orally disintegrating selegiline). Percentages of participants with reduction in individual adverse events as well as reduction in any adverse events are reported.|3 Months|77 patients enrolled in the study and 60 completed. Each patient had to have at least one of the following DA related AEs, excessive daytime sleepiness, hallucinations, pedal edema or impulse control disorder (they could have more than one AE). 60 subjects were selected based on results of previous studies (discontinued patients were replaced).||percentage of participants|||Number
737070|NCT00447005|Secondary|Accumulation Ratio for Cmax (Rac Cmax) and Accumulation Ratio for AUCtau (Rac AUCtau): Multiple Dose|Rac Cmax is obtained from Cmax (Cycle 1, Day 15) divided by Cmax (Cycle 1, Day 1) Rac AUCtau is obtained from AUCtau (Cycle 1, Day 15) divided by AUCtau (Cycle 1, Day 1)|Multiple dose Cycle 1 Day 1 and 15: predose, 0.5, 1, 2, 4, 8 and 12 hours postdose|Participants who received at least one study drug and completed pharmacokinetic blood sampling for at least one day (Pharmacokinetic Analysis Set); n= number of participants assessed.||ratio||Standard Deviation|Mean
737041|NCT00443898|Secondary|Number of Participants Assessed With Adverse Events and Serious Adverse Events|"An adverse event (AE) is any adverse change in health or side effect that occurs while the participant is receiving the treatment or within a previously specified period of time after the treatment has been completed.
A Serious Adverse Event (SAE) is any untoward medical occurrence that results in death, is life-threatening requires, inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage."|52 weeks|Safety Population was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety assessment. All except 4 participants who were randomized to the vehicle 24 w group and one participant randomized to the terbinafine 48 w group, were included in the safety population.||Participants|||Number
737042|NCT00443898|Secondary|Efficacy Assessed by Clinical Efficacy at the End of Study After Treating Patients for 24 or 48 Weeks.|"Clinical effectiveness is defined as negative KOH microscopy and negative culture for dermatophytes and <= 10% residual involvement of the target toenail.
Clinical effectiveness was a composite binary variable defined as
Yes” if
Mycological cure (negative KOH and negative culture for dermatophytes) and
= 10% residual involvement of the target toenail
No” if otherwise"|52 weeks|All participants were included in the intention to treat (ITT) population, defined as all participants who were randomized and received study drug. The Last Observation was Carried Forward (LOCF).||Percentage of Participants|||Number
737043|NCT00443898|Secondary|Efficacy Assessed by Mycological Cure (Negative Culture and Negative KOH Microscopy) at the End of Study After Treating Patients for 24 or 48 Weeks.|"Mycological cure is defined as negative KOH microscopy and negative culture for dermatophytes.
Mycological cure was a composite binary variable defined as
Yes”if :
Negative microscopy and
Negative culture for dermatophytes
No” if otherwise."|52 weeks|All participants were included in the intention to treat (ITT) population, defined as all participants who were randomized and received study drug. The Last Observation was Carried Forward (LOCF).||Percentage of Participants|||Number
737044|NCT00443898|Primary|Efficacy Assessed by Complete Cure Rate at the End of Study (Week 52) After Treating for 24 or 48 Weeks.|"Complete cure is defined as negative KOH microscopy and negative culture for dermatophytes.
and no residual involvement of the target toenail. The complete cure was a composite binary variable defined as
Yes” if:
Mycological cure (negative KOH and negative culture for dermatophytes) and
No residual involvement of the target toenail
No” if otherwise"|52 weeks|All participants were included in the intention to treat (ITT) population, defined as all participants who were randomized and received study drug. The Last Observation was Carried Forward (LOCF).||Percentage of Participants|||Number
737045|NCT00444067|Other Pre-specified|Incidence of Post-Operative Surgical Site Infections (SSIs)|"•Percentage of participants who incur an SSI within 90 days post-procedure determined by clinical diagnosis
SSIs were diagnosed and classified in accordance with the Centers for Disease Control (CDC) criteria for evaluation and diagnosis of nosocomial surgical site infections and were classified as one of the following (Superficial, Deep or Organ/Space)."|90 Days|Fisher’s Exact Test was used to test for a difference in the proportions of subjects with SSIs between the two treatments. Confidence intervals were produced based on the observed percentage and also on the percentage estimated using the Kaplan-Meier method.||percentage of participants||95% Confidence Interval|Number
737046|NCT00444067|Other Pre-specified|Incidence of Post-Operative CSF Leaks|"Percentage of participants with CSF leaks within 90 days post-operatively as determined from clinical diagnosis by one of the following methods:
CSF leak or pseudomeningocele related surgical intervention (i.e., breaking skin) within 90 days post-procedure; or
CSF leak confirmation by diagnostic testing within 90 days post-procedure; or
CSF leak confirmation by clinical evaluation within 90 days post-procedure"|90 Days|Fisher’s Exact Test was used to test for a difference in the proportions of subjects with CSF leaks between the two treatments. Confidence intervals were produced based on the observed percentage and also on the percentage estimated using the Kaplan-Meier method.||percentage of participants||95% Confidence Interval|Number
737047|NCT00444067|Primary|Percent(%) Success in Obtaining a Watertight Closure Following Assigned Treatment (Spinal Sealant or Control)|"Percent(%) success in obtaining a watertight closure following assigned treatment (Spinal Sealant or Control) where success is defined as:
A watertight closure of the dural repair intraoperatively after study treatment, confirmed by Valsalva maneuver at 20-25 cm H2O for 5-10 seconds."|Intra-operative|The primary analysis for the primary efficacy endpoint was performed using a two-sided Fisher’s Exact Test to test for a difference in the true success rates in obtaining a watertight closure between treatments.||percentage of participants||95% Confidence Interval|Number
737048|NCT00444106|Secondary|Efficacy of Polymerase Chain Reaction (PCR) Adjusted Malaria Cure Rates of the Three Treatment Regimens at Days 14, 28 and 42|Percentage of patients with clearance of asexual parasitemia (observed by optical microscopy) within 7 days of initiation of trial treatment without recrudescence within 14, 28 and 42 days respectively after initiation of treatment. Patients with recurrent parasitemia and paired PCR results were classified as either a new infection (different paired genotypes) or a recrudescence (matching paired genotypes). Patients without paired PCR results or ambiguous results were classified as treatment failures.|Days 14, 28 and 42|Full Analysis Set defined as all randomized patients with confirmed malaria at baseline, who had at least one dose of study drug and had at least one relevant post-baseline efficacy assessment.||Percentage of Participants||95% Confidence Interval|Number
737049|NCT00444106|Secondary|Relationship Between Changes in Auditory Function and Treatment Groups|ABR Wave III latency (ms) changes from baseline to Day 7 in the three drug exposure groups.|From Baseline to Day 7|||ms||95% Confidence Interval|Mean
737050|NCT00444106|Secondary|Auditory Changes Following 3 Days of Treatment at Days 3, 7, 28, and 42 Days as Assessed by Pure Tone Thresholds Assessments (a Type of Hearing Test)|Audiometric measurements such as pure-tone threshold (air conduction tested at 250 to 8000 HZ) day 3, 7, 28 and 42 following initiation of treatment, including changes from baseline. Pure-tone average (PTA) calculated for each ear by averaging the pure-tone threshold values at 500, 1000, 2000 and 3000 HZ.|Baseline (Day 1), 3, 7, 28 and Day 42|Safety per protocol patients who had a valid ABR at baseline and on the specified day were included.||dB||95% Confidence Interval|Mean
737287|NCT00448682|Secondary|Number of Participants Experiencing Adverse Events|Number of participants experiencing adverse events within 1 year of receiving combination therapy of FUDR + Leucovorin + Oxaliplatin + Docetaxel for metastatic gastric adenocarcinoma.|1 year|The study data has not been analyzed.|||||
737051|NCT00444106|Primary|Percentage of Participants With Auditory Abnormalities at Day 7 Assessed by Auditory Brainstem Response (ABR) Wave III Latency Changes on Day 7(a Type of Hearing Test)|"To demonstrate the safety of artemether-lumefantrine after 3 days of treatment in patients with acute, uncomplicated falciparum malaria by testing the null hypothesis that the rate of auditory abnormalities is ≥ 15% in the population treated with artemether-lumefantrine as assessed by ABR at Day 7 following initiation of treatment compared with their baseline values. An auditory nerve abnormality is here defined as a greater than 0.30 ms change in Wave III latency from baseline to Day 7. Exact Pearson-Clopper two-sided 95% confidence limits were constructed for all three treatment groups."|7 days|Safety per protocol set defined as all the randomized patients who took at least 80% of the entire recommended dose and had a valid baseline and Day 7 ABR Wave III latency evaluation and did not use any meds having an ototoxic effect.||Percentage of Participants||95% Confidence Interval|Number
737052|NCT00444145|Primary|Number of Patients With Dilation of Intracellular Spaces 3 Months After Therapy|Dilation of inter cellular spaces (the space within the cell) is reported to be an early morphological (structure and form) marker in gastro-oesophageal reflux. Using electron microscopy, the distance between epithelial cells is quantified.|3 months|||participants|||Number
737053|NCT00446849|Secondary|Endoscopic Remission of UC During the Maintenance Phase at 12 Months|Endoscopic remission is defined as an endoscopy score of less than or equal to 1. Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal [intact vascular pattern; no friability or granulation], 1 = mild [erythema; decreased vascular pattern; minimal granularity], 2 = moderate [marked erythema; granularity; friability; absent vascular pattern; bleeding with minimal trauma; no ulcerations], 3 = severe [ulceration; spontaneous bleeding].|12 Months|MPEP with non-missing data at 12 months.||Participants|||Number
737054|NCT00446849|Secondary|Quiescent UC During the Maintenance Phase at 12 Months|Quiescent UC is defined as scores of 0 for both rectal bleeding and bowel movements. Rectal bleeding is assessed on a scale from 0-3 (0 = no rectal bleeding, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood). Bowel movements are assessed on a scale of 0-2 (0 = 0-1 more than normal per day, 1 = 2-3 more than normal per day, 2 = 4 or more than normal per day).|12 Months|MPEP with non-missing data at 12 months.||Participants|||Number
737055|NCT00446849|Secondary|Clinical Recurrence of UC During the Maintenance Phase Associated With Subject Compliance at 12 Months|Clinical recurrence is defined as 4 or more bowel movements per day above the subject's normal frequency and associated with any of the following: urgency, abdominal pain, or rectal bleeding. Compliance is a subject's adherence to a recommended course of treatment and for this study is calculated: (Sum of days' supplies dispensed) divided by (Sum of days in all refill intervals) x 100.|12 months|MPEP with non-missing data for clinical recurrence at 12 months.||Percent of participants|||Number
737056|NCT00446849|Secondary|Clinical Recurrence of UC During the Maintenance Phase Associated With Subject Compliance at 6 Months|Clinical recurrence is defined as 4 or more bowel movements per day above the subject's normal frequency and associated with any of the following: urgency, abdominal pain, or rectal bleeding. Compliance is a subject's adherence to a recommended course of treatment and for this study is calculated: [(Sum of days' supplies dispensed) divided by (Sum of days in all refill intervals)] x 100.|6 Months|MPEP with non-missing data for clinical recurrence at 6 months.||Percent of participants|||Number
737057|NCT00446849|Secondary|Clinical Recurrence of UC During the Maintenance Phase at 12 Months|Clinical recurrence is defined as 4 or more bowel movements per day above the subject's normal frequency and associated with any of the following: urgency, abdominal pain, or rectal bleeding.|12 Months|MPEP||participants|||Number
737058|NCT00446849|Primary|Clinical Recurrence of Ulcerative Colitis (UC) During the Maintenance Phase at 6 Months|Clinical recurrence is defined as 4 or more bowel movements per day above the subject's normal frequency and associated with any of the following: urgency, abdominal pain, or rectal bleeding.|6 months|Maintenance phase efficacy population (MPEP) includes all subjects who, during the maintenance phase, took at least 1 dose of study medication and had at least 1 post-dose efficacy assessment.||participants|||Number
737059|NCT00446992|Primary|LDL||Baseline and 4 week intervals|||mg/dL||Standard Deviation|Mean
737060|NCT00446992|Primary|HDL||Baseline and 4 week intervals|||mg/dL||Standard Deviation|Mean
737061|NCT00446992|Primary|Cholesterol Total||Baseline and 4 week intervals|||mg/dL||Standard Deviation|Mean
737062|NCT00446992|Primary|Triglycerides||Baseline and 4 week intervals|||mg/dL||Standard Deviation|Mean
737063|NCT00446992|Primary|IL-6||Baseline and 4 week intervals|||pg/mL||Standard Deviation|Mean
737064|NCT00446992|Primary|Hemoglobin A1c||Baseline and 4 week intervals|||percentage||Standard Deviation|Mean
737065|NCT00446992|Primary|Fasting Insulin||Baseline and 4 week intervals|||mg/dL||Standard Deviation|Mean
737066|NCT00446992|Primary|Fasting Glucose||Baseline and 4 week intervals|||mg/dL||Standard Deviation|Mean
737067|NCT00446992|Primary|Body Mass Index||Baseline and 4 week intervals|||kg/m^2||Standard Deviation|Mean
737068|NCT00447005|Secondary|The Numbers of Participants With Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), and Progression of Disease (PD) According to the Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0)|CR was defined as the disappearance of all target and nontarget lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters (SLD) of the targeted lesions. CR and PR had to be documented on 2 occasions separated by at least 4 weeks. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify as PD being demonstrated during the first 8 weeks. PD was defined as at least a 20% increase in the SLD of target lesions compared to the smallest SLD since the study treatment started.|Up to 795 days|Participants with at least 1 target lesion according to RECIST and who received at least 1 dose of study drug (Anti-tumor Response Analysis Set).||participants|||Number
737069|NCT00447005|Secondary|Percent Change From Baseline in Soluble Vascular Endothelial Growth Factor Receptor 2 and 3 (s-VEGFR2 and s-VEGFR3), Vascular Endothelial Growth Factor (VEGF), Soluble Stem Cell Factor Receptor (s-KIT)|Percent change from baseline is obtained from (observed value minus baseline value) divided by baseline value multiplied by 100 in each parameter, i.e., VEGFR2, s-VEGFR3, s-KIT, and VEGF.|Prior to the initial dose (baseline), Day 1 of Cycle 2 and at the discontinuation|Participants who received at least one study drug and completed pharmacodynamic blood sampling for at least one day (Pharmacodynamic Analysis Set); n= number of participants assessed.||percent change||Full Range|Median
737071|NCT00447005|Secondary|Area Under The Plasma Concentration-Time Curve Over Dosing Interval Tau (AUCtau): Multiple Dose|Dosing Interval was 12 hours in this study.|Multiple dose Cycle 1 Day 1 and 15: predose, 0.5, 1, 2, 4, 8 and 12 hours postdose|Participants who received at least one study drug and completed pharmacokinetic blood sampling for at least one day (Pharmacokinetic Analysis Set); n= number of participants assessed.||ng*h/mL||Standard Deviation|Mean
737072|NCT00447005|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax): Multiple Dose||Multiple dose Cycle 1 Day 1 and 15: predose, 0.5, 1, 2, 4, 8 and 12 hours postdose|Participants who received at least one study drug and completed pharmacokinetic blood sampling for at least one day (Pharmacokinetic Analysis Set); n= number of participants assessed.||hours||Full Range|Median
737073|NCT00447005|Secondary|Maximum Observed Plasma Concentration (Cmax): Multiple Dose||Multiple dose Cycle 1 Day 1 and 15: predose, 0.5, 1, 2, 4, 8 and 12 hours postdose|Participants who received at least one study drug and completed pharmacokinetic blood sampling for at least one day (Pharmacokinetic Analysis Set); n= number of participants assessed.||ng/mL||Standard Deviation|Mean
737074|NCT00447005|Secondary|Terminal Phase Plasma Half-Life (t1/2): Single Dose|t1/2 is the time measured for the plasma concentration to decrease by one half.|Single dose: predose, 0.5, 1, 2, 4, 6, 8, 12, 24, and 32 hours postdose|Participants who received at least one study drug and completed pharmacokinetic blood sampling for at least one day (Pharmacokinetic Analysis Set). Only the first 6 participants were administered a single dose.||hours||Standard Deviation|Mean
737075|NCT00447005|Secondary|Area Under The Plasma Concentration-Time Curve From Time Zero to Time Infinity (AUCinf): Single Dose|AUCinf is obtained from AUC (0 - t) plus AUC (t - infinity).|Single dose: predose, 0.5, 1, 2, 4, 6, 8, 12, 24, and 32 hours postdose|Participants who received at least one study drug and completed pharmacokinetic blood sampling for at least one day (Pharmacokinetic Analysis Set). Only the first 6 participants were administered a single dose.||ng*hr/mL||Standard Deviation|Mean
737076|NCT00447005|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax): Single Dose||Single dose: predose, 0.5, 1, 2, 4, 6, 8, 12, 24, and 32 hours postdose|Participants who received at least one study drug and completed pharmacokinetic blood sampling for at least one day (Pharmacokinetic Analysis Set). Only the first 6 participants were administered a single dose.||hours||Full Range|Median
737077|NCT00447005|Secondary|Maximum Observed Plasma Concentration (Cmax): Single Dose||Single dose: predose, 0.5, 1, 2, 4, 6, 8, 12, 24, and 32 hours postdose|Participants who received at least one study drug and completed pharmacokinetic blood sampling for at least one day (Pharmacokinetic Analysis Set). Only the first 6 participants were administered a single dose.||ng/mL||Standard Deviation|Mean
737078|NCT00447005|Primary|Number of Participants With Adverse Events|Number of participants with any adverse events, adverse events graded as Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE) Grade 3 or higher, serious adverse events, and adverse events resulted in discontinuation.|Up to 795 days of treatment plus 28-days follow-up|All subjects who received at least 1 dose of the study drug.||participants|||Number
737079|NCT00447057|Secondary|Number of Participants With Adverse Events (AEs)|Summaries of serious AEs (SAEs) and all other non-serious AEs are located in the Reported Adverse Event Module.|Baseline up to 42.2 months|All participants who received at least 1 dose of study drug were analyzed for safety. Nonsquamous and squamous populations are combined.||participants|||Number
737080|NCT00447057|Secondary|Percentage of Participants Surviving at 1 Year|Overall Survival (OS) rate at 1 year from the date of randomization was determined using the distribution of OS times and was estimated using the Kaplan-Meier method.|Baseline to date of death from any cause up to 1 year|"Includes nonsquamous population only.
On the Pemetrexed arm, 17 participants were censored overall and on the Pemetrexed + Erlotinib arm, 28 participants were censored overall."||Percentage participants with OS ≥1 year||95% Confidence Interval|Median
737081|NCT00447057|Secondary|Overall Survival (OS)|OS time is the duration from randomization to the date of death from any cause. For each participant who was not known to have died as of the data inclusion cut-off date, OS was censored at the date of last contact.|Baseline to date of death from any cause. Maximum follow-up was from Baseline to 42.6 months.|Pemetrexed arm: 17 (20.5%) participants censored Pemetrexed + Erlotinib arm: 28 (36.8%) participants censored||months||95% Confidence Interval|Median
737082|NCT00447057|Secondary|Time to Treatment Failure (TTTF)|"Defined as the time from randomization to death from any cause, first observation of PD, or study treatment discontinuation due to any reason other than “protocol complete” or “satisfactory response”. For participants who discontinued due to protocol complete or satisfactory response, or for participants not known to have discontinued as of the data cut-off date, TTTF was censored at the last contact date."|"Baseline to first date among death from any cause, PD, or study treatment discontinuation for any reason other than protocol complete or satisfactory response. Maximum follow-up was from Baseline to 32.2 months"|Includes nonsquamous population only.||months||95% Confidence Interval|Median
737083|NCT00447057|Secondary|Percentage of Participants With Best Response of Complete Response (CR) or Partial Response (PR) (Response Rate)|"CR: Disappearance of all tumor lesions; PR: Either a) at least a 30% decrease in sum of LD of target lesions or b) complete disappearance of target lesions, with persistence (but not worsening) ≥1 nontarget lesions. In either case, no new lesions may have appeared.
SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.
PD: ≤20% increase in the sum of LD of target lesions. Response Rate (%) = (CR+PR)/number of participants in arm*100."|Baseline to measured progressive disease. Maximum follow-up was from Baseline to 34 months|Includes nonsquamous population only.||percentage of participants||95% Confidence Interval|Number
737084|NCT00447057|Secondary|Percentage of Participants With Best Response of Stable Disease (SD), Partial Response (PR) or Complete Response (CR) (Disease Control Rate)|"Per RECIST:
CR: Disappearance of all target lesions; PR: Either a) ≤30% decrease in sum of longest diameter (LD) of target lesions or b) complete disappearance of target lesions, with persistence (but not worsening) of ≥1 nontarget lesions. In either case, no new lesions may have appeared.
SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.
PD: ≤20% increase in sum of LD of target lesions. Disease Control Rate (%) = (SD+PR+CR)/number of participants in arm*100."|Baseline to measured PD. Maximum follow-up was from Baseline to 34 months|Includes nonsquamous population only.||percentage of participants||95% Confidence Interval|Number
737377|NCT00440830|Secondary|Diastolic Blood Pressure|Diastolic blood pressure reported in Millimeters of Mercury (mmHg)|1 hour after surgery||||||
737085|NCT00447057|Primary|Progression Free Survival (PFS)|PFS per Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 criteria using computed tomography (CT) or magnetic resonance imaging (MRI) for objective determination of progressive disease (PD: ≤20% increase in sum of longest diameter of target lesion). For participants alive as of data cut-off date who did not have PD, PFS was censored at date of last CT/MRI. For participants who received subsequent systemic anticancer therapy (after study discontinuation) prior to PD or death, PFS censored at date of last CT/MRI prior to initiation of post discontinuation systemic anticancer therapy.|Baseline to date of measured PD or death from any cause. Maximum follow-up was from baseline to 32.2 months|"Includes Nonsquamous population only.
In Pemetrexed arm, 13 (15.7%) participants censored overall: 12 (14.5%) because of receiving subsequent systemic anticancer therapy.
In Pemetrexed + Erlotinib arm, 16 (21.1%) participants censored overall: 9 (11.8%) because of receiving subsequent systemic anticancer therapy."||months||95% Confidence Interval|Median
737086|NCT00447122|Secondary|Toxicity||1 year||||||
737087|NCT00447122|Primary|Number of Patients Who Survived at 4 Months: Overall Survival||4 months|||participants|||Number
737088|NCT00447226|Secondary|Incidence of ErbB2-positive Participants|The number of ErbB2-positive participants (determined by FISH assay) compared to the total number of participants screened was to be recorded. Over-expression of ErbB2 has been correlated with an overall poor prognosis. Data were not analyzed, due to early study termination.|Screening|All participants who were screened to determine their eligibility to enter into the study||participants per total screened|||Number
737089|NCT00447226|Secondary|Incidence of MET Amplification in Gastric Cancer|The number of gastric cancer participants with MET amplification (determined by fluorescence in situ hybridization [FISH] assay) compared to the total number of gastric cancer participants screened was to be recorded. Amplification of the MET gene has been reported to be related to carcinogenesis, progression of gastric cancer, and poor prognosis. Data were not analyzed due to early study termination.|Performed on archived tissue collected at screening.|All participants with gastric cancer who were screened to determine their eligibility to enter into the study||participants per total screened|||Number
737090|NCT00447226|Secondary|Number of Participants With the Indicated Change in Cancer Antigen-125 (CA-125) Levels From Day 1|CA-125 is a “tumor marker”, found in greater concentration in tumor cells than other cells of the body. In particular, CA-125 is present in greater concentration in ovarian cancer cells than in other cells. A decreasing level generally indicates that therapy has been effective, whereas an increasing level indicates tumor recurrence.|Pre-dose and every 6 weeks until withdrawal (up to 84.1 weeks)|Participants with ovarian cancer. The number of participants for whom there are data varies at each time point, depending on how many participants had CA-125 samples.||participants|||Number
737091|NCT00447226|Secondary|Time to Disease Progression (TTP)|"Time to disease progression was calculated as the time from the start of treatment to disease progression or death due to disease progression. For participants who did not progress, the date of last contact was used and for those who died due to other causes, the date of death was used. The word used for such participants was censored. As the median value in the placebo arm was not reached (2 participants were censored and 2 were ongoing), results for the placebo arm are not displayed in the table below."|From start of treatment to disease progression/death (up to 83.3 weeks)|All Treated: all participants who received at least one dose of open-label lapatinib.||weeks||95% Confidence Interval|Median
737092|NCT00447226|Secondary|Progression-free Survival (PFS)|"Progression-free survival was calculated as the time from the start of treatment until disease progression or death. For participants who did not have disease progression or did not die, the date on which alternative anti-cancer therapy began was used, or the date of last contact (if sooner). The word used for such participants was censored. Data were not analyzed due to early study termination."|From start of treatment to disease progression/death (assessments every 12 weeks until death for withdrawn participants and every 3 weeks for participants continuing on lapatinib)|All treated: all participants who received at least one dose of open-label lapatinib.||weeks||95% Confidence Interval|Median
737093|NCT00447226|Secondary|Duration of Response|Duration of response was calculated as the time from first documented partial response (PR; >=30% decrease in the measurements of the largest lesions) or complete response (CR; disappearance of all lesions) until disease progression, the time when the participant began a new anti-cancer therapy, or death. Data were not analyzed due to early study termination.|(assessments every 12 weeks until death for withdrawn participants and every 3 weeks for participants continuing on lapatinib)|All treated: all participants who received at least one dose of open-label lapatinib.||weeks||95% Confidence Interval|Median
737094|NCT00447226|Primary|Percentage of Participants Who Remained Progression-free 12 Weeks After Randomization|The percentage of participants who did not show signs of progressive disease 12 weeks after receiving lapatinib or placebo in Stage 2 of the study (participants who maintained SD in Stage 1 were randomized to either lapatinib or placebo) was measured. Formal statistics for treatment comparison were not performed, due to early study termination. The percentage of participants displayed below includes those with CR + PR + SD.|Week 12 after randomization.|Intent-to-Treat Population: all participants randomized to study treatment in Stage 2||percentage of participants|||Number
737095|NCT00447226|Primary|Number of Participants With the Indicated Tumor Response at 12 Weeks From First Dose|Per Response Evaluation Criteria In Solid Tumors (RECIST): Complete response (CR), disappearance of all lesions; partial response (PR), >=30% decrease in the measurements of the largest lesions; stable disease (SD), insufficient shrinkage to qualify for PR or insufficient increase to qualify for progressive disease (PD); PD, >=20% increase in measurements of lesions or appearance of new lesions. Data were not fully analyzed due to early study termination.|Week 12|All treated: all participants who received at least one dose of open-label lapatinib.||participants|||Number
737096|NCT00447265|Secondary|Participant Medical Outcome Study Short Form 36 (SF-36) Mental Component Score at Baseline and Week 24|"Reported here are the participant SF-36 Mental Component scores at baseline and week 24. The SF-36 measures 8 domains: physical functioning, role limitations due to physical health, bodily pain, social functioning, mental health, role limitations due to emotional problems, vitality, and general health perceptions.[1] The Mental Component score of the SF-36 ranges from 0 to 100; 0 equals worst health state. Higher numbers reported here indicate more improvement in condition from baseline.
[1]Ref: Ware JE, Sherbourne CD. The MOS36-item short-form health survey. Med Care. 1992; 30:473-483"|Baseline, Week 24|||Score on a scale|||Number
737378|NCT00440830|Secondary|Systolic Blood Pressure|Systolic blood pressure reported in Millimeters of Mercury (mmHg)|1 hour after surgery||||||
737097|NCT00447265|Secondary|Participant Medical Outcome Study Short-Form 36 (SF-36) Physical Component Score at Baseline and Week 24|"Reported here is the participant baseline and week 24 SF-36 Physical Component scores. The SF-36 measures 8 domains: physical functioning, role limitations due to physical health, body pain, social functioning, mental health, role limitations due to emotional problems, vitality, and general health perceptions[1]. The Physical Component scores of the SF-36 range from 0 to 100; 0 equals worst health state. Higher numbers reported here indicate more improvement in condition from baseline.
[1]Ref: Ware JE, Sherbourne CD. The MOS36-item short-form health survey Med Care. 1992; 30:473-483."|Baseline, Week 24|||Score on a scale|||Number
737098|NCT00447265|Secondary|Number of Participants With an A to B Score Change From Baseline to Week 24 in the British Isles Lupus Assessment Group (BILAG) Renal Score|Reported here is the number of participants with a change in their BILAG Renal Score from A (at baseline) to B (at week 24). A single alphabetic score (A through E) is used to denote disease severity. The BILAG score is a converted numerical score (A=9, B=3, C=1, D=0, E=0).A maximum renal score of 9 signifies higher disease activity and a score of 0 is indicative of inactive systematic lupus erythematosus (SLE) in the specified organ system|Baseline, Week 24|||Participants|||Number
737099|NCT00447265|Secondary|Number of Participants With a B to D Change From Baseline to Week 24 in the British Isles Lupus Assessment Group (BILAG) Musculoskeletal Score|Reported here is the number of participants with a change in their BILAG Musculoskeletal Score from B (at baseline) to D (at week 24). A single alphabetic score (A through E) is used to denote disease severity. The BILAG score is a converted numerical score (A=9, B=3, C=1, D=0, E=0).A maximum musculoskeletal score of 9 signifies higher disease activity and a score of 0 is indicative of inactive systematic lupus erythematosus (SLE) in the specified organ system.|Baseline, Week 24|||Participants|||Number
737100|NCT00447265|Secondary|Number of Participants With a C to B Score Change From Baseline to Week 24 in the British Isles Lupus Assessment Group (BILAG) Mucocutaneous Score|Reported here is the number of participants with a change in their BILAG Mucocutaneous Score from C (at baseline) to B (at week 24). A single alphabetic score (A through E) is used to denote disease severity. The BILAG score is a converted numerical score (A=9, B=3, C=1, D=0, E=0). A maximum mucocutaneous score of 9 signifies higher disease activity and a score of 0 is indicative of inactive systematic lupus erythematosus (SLE) in the specified organ system.|Baseline, Week 24|||Participants|||Number
737101|NCT00447265|Secondary|Participant Systematic Lupus Erythematosus Disease Activity Index (SLEDAI) Score at Baseline and at Early Study Withdrawal Visit|Reported here is the baseline and week 39 Systematic Lupus Erythematosus Disease Activity Index (SLEDAI) scores. The SLEDAI is a concise measure of lupus disease activity with excellent test-retest reliability and high responsiveness to clinically important changes in the disease. The total score is derived from ratings on 24 conditions plus the Physician's Global Assessment; 0 indicates inactive disease and the maximum theoretical score is 105, with higher scores representing increased disease activity.|Baseline, Week 39 (Early Study Withdrawal Visit)|||Points on a scale|||Number
737102|NCT00447265|Secondary|Time to Participant's Renal Response|"Time to when participant achieved a renal response[1]
[1]A renal response is defined as: 1) 50% reduction in proteinuria compared to baseline as measured by urinary protein: creatinine ratio; and 2) stable or improving renal function as defined by the Glomerular filtration rate (GFR) calculated based on the Modification of Diet in Renal Disease equation (Levy, AS, Coresh J, Galk E et al, National Kidney Foundation practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Ann Intern Med, 139(2): 137-47, 2003)"|First 24 Weeks of Study Period|||Weeks|||Number
737103|NCT00447265|Secondary|Percent of Participants Who Achieved a Renal Response at Week 24|"Percent of study participants who achieved a renal response at 24 weeks.[1]
[1]A renal response is defined as: 1) 50% reduction in proteinuria compared to baseline as measured by urinary protein: creatinine ratio; and 2) stable or improving renal function as defined by the Glomerular filtration rate (GFR) calculated based on the Modification of Diet in Renal Disease equation (Levy, AS, Coresh J, Galk E et al, National Kidney Foundation practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Ann Intern Med, 139(2): 137-47, 2003)"|Week 24|||Percent of Participants|||Number
737104|NCT00447265|Secondary|Number of Participant Adverse Events (AEs) From Baseline to Early Study Withdrawal Visit|Number of participant AEs during the trial. This study graded the severity of AEs experienced by the study participant according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0.|39 Weeks|||Events|||Number
737105|NCT00447265|Primary|Number of Adverse Events (AEs)Grade 3 or Higher Experienced by Participant During Treatment Phase of Study|"Number of adverse events (AEs) or serious adverse events (SAEs) Grade 3 or higher experienced by participant over the duration of the treatment period. [1]
[1] This study graded the severity of AEs experienced by the study participant according to the criteria set forth in the National Cancer Institute’s Common Terminology Criteria for Adverse Events Version 3.0."|24 Weeks|||Events|||Number
737106|NCT00447278|Secondary|Correlation Between CHIP-CE Parent Rated and Pooled CHIP-CE Child Rated and CHIP AE Adolescent Rated T-Scores|Pearson correlation coefficients were calculated on each domain at baseline, Month 6 and Change to Month 6 between parent-rated CHIP and pooled patient-rated (child and adolescent) CHIP.|Baseline, 6 months|All randomized participants who received at least one dose of study drug and had non-missing values.||correlation coefficient|||Number
737107|NCT00447278|Secondary|Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-Adolescent Edition (AE) for Adolescents (>11-17 Years)|CHIP-AE CRF: adolescent rated assessment of their health status and level of functioning. Domains: Achievement, Satisfaction, Comfort, Risk Avoidance, Resilience. The majority of items assess frequency of activities or feelings using a 5-point response format (1=never, 5=always). Standard scores (T-scores) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Normative range is 40 to 60. Higher scores indicate better health and lower scores indicate worse health.|Baseline, 4 months, 6 months, 12 months|"Number of adolescent participants who received at least one dose of study drug and did not have a missing value. Last observation carried forward (LOCF). Change at 12 months is in the participants who continue in the optional extension period (atomoxetine n=27, OEST n=31). Their data at 6 months was taken as baseline for the 12 month change."||T-Scores of units on a scale||Standard Deviation|Mean
737379|NCT00440830|Secondary|Pain Medication Used|Pain medication used after surgery in morphine equivalents|5 days||||||
737380|NCT00440830|Secondary|Sedation|Observer's Assessment of Alertness/Sedation Scale was used to report sedation.|1 hour after surgery||||||
737108|NCT00447278|Secondary|Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE CRF for Children (6-11 Years)|CHIP-CE CRF: child rated assessment of their health status and level of functioning. Domains: Achievement, Satisfaction, Comfort, Risk Avoidance, Resilience. The majority of items assess frequency of activities or feelings using a 5-point response format (1=never, 5=always). Standard scores (T-scores) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Normative range is 40 to 60. Higher scores indicate better health and lower scores indicate worse health.|Baseline, 4 months, 6 months, 12 months|"Number of child participants who received at least one dose of study drug and did not have a missing value. Last observation carried forward (LOCF). Change at 12 months is in the participants who continue in the optional extension period (atomoxetine n= 112, OEST n=124). Their data at 6 months was taken as baseline for the 12 month change."||T-Scores of units on a scale||Standard Deviation|Mean
737109|NCT00447278|Secondary|Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Clinical Global Impression Attention-Deficit/Hyperactivity Disorder - Severity (CGI-ADHD-S)|Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).|Baseline, 4 months, 6 months, 12 months|Number of participants who received at least one dose of study drug and did not have a missing value. Last observation carried forward (LOCF). Change at 12 months is in the participants who continue in the optional extension period (atomoxetine n= 139, OEST n=155). Their data at 6 months was taken as baseline for the 12 month change.||units on a scale||Standard Deviation|Mean
737110|NCT00447278|Secondary|Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Attention-Deficit/Hyperactivity Disorder Rating Scale - Parent Version: Investigator Adminitered and Scored (ADHD-RS-IV Parent:Inv)|Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. Inattention and Hyperactivity-Impulsivity subscales consisted of 9 items each, for total subcale scores ranging from 0 to 27. Higher scores are indicative of more severe symptoms.|Baseline, 4 months, 6 months, 12 months|Number of participants who received at least one dose of study drug and did not have a missing value. Last observation carried forward (LOCF). Change at 12 months is in the participants who continue in the optional extension period (atomoxetine n= 139, OEST n=155). Their data at 6 months was taken as baseline for the 12 month change.||units on a scale||Standard Deviation|Mean
737111|NCT00447278|Secondary|Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P)|The 50-item WFIRS-P rates impairment in 6 domains of functioning: home, school, self-concept, social, activities of daily living, and risk taking. Each item is rated by the parent on a 4-point Likert scale from 0 to 3 (0=“never or not at all”, 1=”sometimes or somewhat”, 2=”often or much”, 3=“very often or very much”). Average of non-missing values were calculated for each domain as well as the Total, which combined all 6 domains; therefore each scale including total has a range of 0 (best) to 3 (worst).|Baseline, 4 months, 6 months, 12 months|Number of participants who received at least one dose of study drug and did not have a missing value. Last observation carried forward (LOCF). Change at 12 months is in the participants who continue in the optional extension period (atomoxetine n= 139, OEST n=155). Their data at 6 months was taken as baseline for the 12 month change.||units on a scale||Standard Deviation|Mean
737112|NCT00447278|Secondary|Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE PRF Domain Scores (Satisfaction, Comfort, Resilience and Risk Avoidance)|CHIP-CE PRF: parent rated assessment of a child’s health status and level of functioning. Domains: Satisfaction, Comfort, Risk Avoidance, Resilience. The majority of items assess frequency of activities or feelings using a 5-point response format (1=never, 5=always). Standard scores (T-scores) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Normative range is 40 to 60. Higher scores indicate better health and lower scores indicate worse health.|Baseline, 4 months, 6 months, 12 months|Number of participants who received at least one dose of study drug and did not have a missing value. Last observation carried forward (LOCF). Change at 12 months is in the participants who continue in the optional extension period (atomoxetine n= 139, OEST n=155). Their data at 6 months was taken as baseline for the 12 month change.||T-Scores of units on a scale||Standard Deviation|Mean
737113|NCT00447278|Secondary|Change From Baseline to 4 Month and 12 Month Endpoints in CHIP-CE PRF, Achievement Domain|CHIP-CE PRF: parent rated assessment of a child’s health status/level of functioning. The achievement domain describes developmentally appropriate role functioning in school and with peers. The majority of items assess frequency of activities or feelings using a 5-point response format (1=never, 5=always). Standard scores (T-scores) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Normative range is 40 to 60. Higher scores indicate better health and lower scores indicate worse health.|Baseline, 4 months, 12 months|Number of participants who received at least one dose of study drug and did not have a missing value. Last observation carried forward (LOCF). Change at 12 months is in the participants who continue in the optional extension period (atomoxetine n= 139, OEST n=155). Their data at 6 months was taken as baseline for the 12 month change.||T-Scores of units on a scale||Standard Deviation|Mean
737114|NCT00447278|Primary|Change From Baseline to 6 Month Endpoint in Child Health and Illness Profile - Child Edition, Parent Report Form (CHIP-CE PRF), Achievement Domain|CHIP-CE PRF: parent rated assessment of a child’s health status/level of functioning. The achievement domain describes developmentally appropriate role functioning in school and with peers. The majority of items assess frequency of activities or feelings using a 5-point response format (1=never, 5=always). Standard scores (T-scores) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Normative range is 40 to 60. Higher scores indicate better health and lower scores indicate worse health.|Baseline, 6 months|Number of participants who received at least one dose of study drug and did not have a missing value. Results for Last Observation Carried Forward (LOCF) are included.||T-Scores of units on a scale||Standard Deviation|Mean
737115|NCT00447330|Secondary|Median Survival|Time in months from the start of study treatment to date of death due to any cause. Median survival was estimated using a Kaplan-Meier curve and is the time point at which 50% of patients remain alive.|5 years after study start date|All patients who received treatment are included in the analysis population. However, 2 patients who never started treatment before leaving the study were excluded from this analysis of survival time.||survival time in months||90% Confidence Interval|Median
737116|NCT00447330|Secondary|Response Rate|The proportion of patients for whom the best overall response is complete response (CR) or partial response (PR). A CR occurs when all lesions disappear; whereas, a PR is indicated when there is at least a 30% decrease in the sum of the longest diameters (LD) of the target lesion. A PD (progressive disese) occurs when there is at least a 20% increase in the sum of the LD relative to the smallest sum LD recorded since treatment is initiated. Disease is considered stable if there is no response and no PD. All patients were assigned a best response for inclusion in this calculation in accordance with the protocol.|Every 9 weeks for up to 1 year|All eligible patients.||percentage of participants||95% Confidence Interval|Number
737117|NCT00447330|Secondary|To Assess the Safety and Tolerability of the Combination of Bevacizumab, Oxaliplatin and Capecitabine in Patients With Previously Untreated Metastatic Esophagogastric Adenocarcinoma|Number of subjects who experienced an adverse event|Every 21 days|||participants|||Number
737118|NCT00447330|Primary|Median Progression-Free Survival (PFS)|Time in months from the start of study treatment to the date of first progression (PD) according to the RECIST criteria, or death due to any cause. PER RECIST, a PD is indicated when there is at least a 20% increase in the sum of the longest diameters from target lesions relative to the smallest sum recorded since treatment is initiated. Median PFS was estimated using a Kaplan-Meier curve, and is the time at which 50% of patients remain alive without disease progression.|5 years from study start date|All patients with at least one scheduled restaging who received treatment. However, an additional 3 patients who progressed before treatment are not included in this analysis.||survival time in months||90% Confidence Interval|Median
737119|NCT00447382|Secondary|Adverse Events||Weeks 0-52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.||events|||Number
737120|NCT00447382|Secondary|Clinical Laboratory Values (Change in Biochemistry - Total Protein)|Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory|Week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.||g/dL||Standard Deviation|Mean
737121|NCT00447382|Secondary|Clinical Laboratory Values (Change in Biochemistry - Sodium)|Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory|Week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.||mmol/L||Standard Deviation|Mean
737122|NCT00447382|Secondary|Clinical Laboratory Values (Change in Biochemistry - Potassium)|Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory|Week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.||mmol/L||Standard Deviation|Mean
737123|NCT00447382|Secondary|Clinical Laboratory Values (Change in Biochemistry - Lactate Dehydrogenase [LDH])|Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory (LDH = lactate dehydrogenase)|Week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.||U/L||Standard Deviation|Mean
737124|NCT00447382|Secondary|Clinical Laboratory Values (Change in Biochemistry - Creatinine)|Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory|Week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a postbaseline observation.||Umol/L||Standard Deviation|Mean
737125|NCT00447382|Secondary|Clinical Laboratory Values (Change in Biochemistry - Alkaline Phosphatase [ALP])|"Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory.
(ALP = alkaline phosphatase)"|Week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.||U/L||Standard Deviation|Mean
737126|NCT00447382|Secondary|Clinical Laboratory Values (Change in Biochemistry - Alanine Aminotransferase [ALAT])|"Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory.
(ALAT = alanine aminotransferase)"|Week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.||U/L||Standard Deviation|Mean
737127|NCT00447382|Secondary|Clinical Laboratory Values (Change in Biochemistry - Albumin)|Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory|Week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.||g/dL||Standard Deviation|Mean
737128|NCT00447382|Secondary|Clinical Laboratory Values (Change in Haematology - Leucocytes)|"Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants.
Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory."|Week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.||Percent (%) of white blood cells||Standard Deviation|Mean
737129|NCT00447382|Secondary|Clinical Laboratory Values (Change in Haematology - Thrombocytes)|Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory.|Week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.||10^9/L||Standard Deviation|Mean
737381|NCT00440830|Secondary|Nausea Assessment by Patient|Nausea scale range: 0=none and 10=the worst, ordinal.|1 hour after surgery||||||
737130|NCT00447382|Secondary|Clinical Laboratory Values (Change in Haematology - Neutrophils)|"Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants.
Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory."|Week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.||Percent (%) of white blood cells||Standard Deviation|Mean
737131|NCT00447382|Secondary|Clinical Laboratory Values (Change in Haematology - Monocytes)|"Change from Baseline to Week 52 is calculated from the change in percentage ((Week 52 %) - (Baseline %)) per participant, averaged across all participants.
Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory."|Week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.||Percent (%) of white blood cells||Standard Deviation|Mean
737132|NCT00447382|Secondary|Clinical Laboratory Values (Change in Haematology - Lymphocytes)|"Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants.
Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory."|Week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.||Percent (%) of white blood cells||Standard Deviation|Mean
737133|NCT00447382|Secondary|Clinical Laboratory Values (Change in Haematology - Haemoglobin)|Change from Baseline to Week 52 is calculated from the change in percentage ((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory.|Week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.||mmol/L||Standard Deviation|Mean
737134|NCT00447382|Secondary|Clinical Laboratory Values (Change in Haematology - Eosinophils)|Change from Baseline to Week 52 is calculated from the change in percentage ((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory.|Week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.||Percent (%) of white blood cells||Standard Deviation|Mean
737135|NCT00447382|Secondary|Clinical Laboratory Values (Change in Haematology - Basophilis)|"Change from Baseline to Week 52 is calculated from the change in percentage ((Week 52 %) - (Baseline %)) per participant, averaged across all participants.
Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory."|week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.||Percent (%) of white blood cells||Standard Deviation|Mean
737136|NCT00447382|Secondary|Change From Baseline in Total Antibodies|Measured change in concentrations of total insulin antibodies values (the sum of insulin detemir specific and insulin detemir – human insulin cross-reacting antibodies) and the change ratio from baseline to end of trial was calculated. The unit for measuring antibody levels is %B/T (amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture). The change ratio does not have any unit as it is a ratio.|Week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.||ratio||Standard Error|Mean
737137|NCT00447382|Secondary|Change From Baseline in Detemir Specific Antibodies|Measured change in concentrations of antibody values for insulin detemir specific antibodies and the change ratio from the baseline to end of trial was calculated. The unit for measuring antibody levels is %B/T (amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture). The change ratio does not have any unit as it is a ratio.|Week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.||ratio||Standard Error|Mean
737138|NCT00447382|Secondary|Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG])|"point is Before Breakfast
point is 120 minutes after Breakfast
point is Before Lunch
point is 120 minutes after Lunch
point is Before Dinner
point is 120 minutes after Dinner
point is at Bedtime
point is At 03:00 A.M.
point is Before Breakfast the Following Day"|week 0, 26 and 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.||mmol/L||Standard Deviation|Mean
737139|NCT00447382|Secondary|Glycaemic Control Parameters (Change in Fasting Plasma Glucose [FPG])||week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.||mmol/L||Standard Error|Mean
737140|NCT00447382|Secondary|Glycaemic Control Parameters (Change in HbA1c)|HbA1c (Glycosylated haemoglobin).|week 0, week 52|All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.||Percent (%) glycosylated haemoglobin||Standard Error|Mean
737141|NCT00447382|Secondary|Hypoglycaemic Episodes|Number of hypoglycaemic episodes from Week 0 to Week 52, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. Hypoglycaemic episodes occurring in the time frame between 23:00 hours (included) and 06:00 hours (excluded) were defined as nocturnal.|Weeks 0-52|All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.||episodes|||Number
737142|NCT00447382|Primary|Change From Baseline in Insulin Detemir – Human Insulin Cross-reacting Antibodies|Measured change in concentrations of insulin detemir cross-reacting antibodies and the change ratio from baseline to end of trial was calculated. The unit for measuring antibody levels is %B/T (amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture). The change ratio does not have any unit as it is a ratio.|week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.||ratio||Standard Error|Mean
737143|NCT00447421|Secondary|Phase 2: Overall Survival|Overall survival was the duration from enrollment to death. For patients who were alive, overall survival was censored at the last contact.|baseline to date of death from any cause|This trial was terminated during the Phase 1 portion of this Phase 1/2 trial. No patients were entered into the Phase 2 portion.||months||Standard Deviation|Mean
737144|NCT00447421|Secondary|Phase 2: Duration of Response|The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.|time of response to progressive disease|This trial was terminated during the Phase 1 portion of this Phase 1/2 trial. No patients were entered into the Phase 2 portion.||months||Standard Deviation|Mean
737145|NCT00447421|Secondary|Phase 2: Time to Progressive Disease|Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause.|baseline to measured progressive disease|This trial was terminated during the Phase 1 portion of this Phase 1/2 trial. No patients were entered into the Phase 2 portion.||months||Standard Deviation|Mean
737146|NCT00447421|Secondary|Phase 2: Complete Response Rate|Complete Response Rate was defined as the proportion of participants having a Complete Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions.|baseline to measured response time|This trial was terminated during the Phase 1 portion of this Phase 1/2 trial. No patients were entered into the Phase 2 portion.||participants|||Number
737147|NCT00447421|Secondary|Phase 1: Best Overall Response|Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.|baseline to measured response|This trial was terminated during the Phase 1 portion of this Phase 1/2 trial and was stopped too early to assess best overall response.||participants|||Number
737148|NCT00447421|Primary|Phase 2: Overall Response Rate|Overall Response Rate (ORR) was defined as the proportion of participants having either a Complete or Partial response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions.|baseline to measured progressive disease|This trial was terminated during the Phase 1 portion of this Phase 1/2 trial. No patients were entered into the Phase 2 portion.||participants|||Number
737149|NCT00447421|Primary|Phase 1: Maximum Tolerated Dose||every cycle|This trial was terminated during the Phase 1 portion of this Phase 1/2 trial and it was too early to assess the recommended dose for Phase 2, or to estimate the maximum tolerated dose (MTD).||milligrams per square meter||Standard Deviation|Mean
737150|NCT00447499|Secondary|Total Health Care Professional Convenience Questionnaire Score at Week 24/Termination|Healthcare professional convenience questionnaires are: Confident the Subject Properly Administering the Injection; Subject Complained About Pain When Administering the Injection; Subject Appreciated the Option of Self-Injection at Home. Each Healthcare professional convenience questionnaire was scored -2, -1, 0, 1 and 2; from most negative to most positive response. A total score across all questions was calculated and was used to evaluate the convenience. The worst total score is -6 and best total score is 6.|24 weeks|All patients enrolled in the study. Patients either switched directly from octreotide (Switch patients, n = 33) or were somatostatin analogue treatment-naïve, or were not currently on octreotide treatment at study start (Other patients, n = 26). Fifty-six of patients had data at Week 24.||On a Scale from -6 to 6||Standard Deviation|Mean
737151|NCT00447499|Secondary|Total Symptom Questionnaire Score at Week 24/Termination|Acromegaly symptoms are sweating, snoring, joint pain, headache and fatigue. Each symptom was scored as -2 = 'always', -1 = 'most of the time', 0 = 'sometimes', 1 = 'rarely and 2 = 'never'. The total score was used to evaluate symptom control in each patient at Week 0 and Week 24/Termination. The total worst score is -10 and best score is 10.|24 Weeks|All patients enrolled in the study. Patients either switched directly from octreotide (Switch patients, n = 33) or were somatostatin analogue treatment-naïve, or were not currently on octreotide treatment at study start (Other patients, n = 26).||On a Scale from -10 to 10||Standard Deviation|Mean
737152|NCT00447499|Secondary|Change of GH Concentration Levels From Basaeline to Week 24 in Switch Patients|Blood samples taken before and 60 and 120 min after glucose load from fasting patient.|24 Weeks|Patients switched directly from octreotide who had GH level measured at the end of study.||ng/mL||Standard Deviation|Mean
737153|NCT00447499|Secondary|Percentage of Switch Subjects That Have Glucose Suppressed GH Levels ≤ 2.5 ng/ml at the End of the Study, Week 24/Termination.|Blood samples taken before and 60 and 120 min after glucose load from fasting patient.|24 Weeks|Patients switched directly from octreotide who had GH level measured at the end of study.||Percent of Participants|||Number
737154|NCT00447499|Secondary|Percentage of Switch Subjects That Have IGF-1 Levels Within the Normal Range for Age and Gender at the End of the Study|Blood sample was collected while subject is in a fasting state or non-fasting state for measuring the level of IGF-1.|24 weeks|Patients switched directly from octreotide who had IGF-1 level measured at the end of study.||Percent of Participants|||Number
737155|NCT00447499|Secondary|Percentage of Switch Subjects Who Find Self-administration of Somatuline Autogel Convenient as Assessed by the Subject Convenience Questionnaire Score.|Experienced Convenience of Somatuline® Autogel® Injections was assessed by the subject as: Very convenient; somewhat convenient; neither convenient nor inconvenient; Neither convenient nor inconvenient; Somewhat inconvenient; very inconvenient.|24 weeks|Patients switched directly from octreotide.||Percent of Participants|||Number
737156|NCT00447499|Primary|The Percentage of Subjects or Their Partners That Are Competent to Self-administer Somatuline Autogel at the End of the Study, (Week 24/Early Termination), as Assessed by the Competence Questionnaire Score.|The primary efficacy endpoint was the percentage of patients (Switch and other) or their partners who were competent to self-administer lanreotide at the end of the study (Week 24/Early Termination), as assessed by the Assessment of Competence Questionnaire (0 = 'No' and 1 = 'Yes').|24 weeks|All patients enrolled in the study. Patients either switched directly from octreotide (Switch patients, n = 33) or were somatostatin analogue treatment-naïve, or were not currently on octreotide treatment at study start (Other patients, n = 26).||Percentage of Participants|||Number
737157|NCT00447590|Secondary|Change in Quality of Life Using Impact of Weight on Quality of Life (IWQOL) Kids Questionnaire|Quality of life was examined using the Impact of Weight on Quality of Life (IWQOL) Kids questionnaire, which has a score range from 0(worst) to 100(best). The change in subjects' IWQOL Kids score was assessed from baseline to 5 years.|Baseline to 5 Years|Participants who completed the IWQOL Kids questionnaire through month 60 (year 5).||units on IWQOL Kids scale||95% Confidence Interval|Mean
737158|NCT00447590|Secondary|Change in Quality of Life Using the Beck Depression Inventory II (BDI)|Quality of life was examined using the Beck Depression Inventory II (BDI) questionnaire, which scores on a range from 0 (best) to 63 (worst). The change in subjects' BDI II score was assessed from baseline to 5 years.|Baseline to 5 Years|Participants who completed the BDI II questionnaire through month 60||units on BDI scale||95% Confidence Interval|Mean
737159|NCT00447590|Secondary|Change in Subjects' Comorbid Conditions|The change from baseline to year five in subjects' comorbid conditions of Type II Diabetes, Dyslipidemia, and Hypertension. Change as reported below indicates the condition resolved.|Baseline to 5 Years|Subjects who had a specific comorbid condition at baseline (Diabetes n=9, Dyslipidemia n=39, Hypertension n=22)||participants whose condition resolved|||Number
737160|NCT00447590|Secondary|Subject Percent Excess BMI Loss|Subject Percent Excess BMI Loss was examined at 5 years post LAP-BAND placement.|Baseline to 5 Years|Intent to treat (ITT) population with imputation at month 60||kg/m2||95% Confidence Interval|Mean
737161|NCT00447590|Secondary|Subject Excess Weight Loss Throughout the Study|Excess Weight Loss was examined over the 5 year period post LAP-BAND implantation. Excess Weight Loss was defined as Weight Loss divided by Excess Weight multiplied by 100.|Baseline to 5 Years|Intent to treat (ITT) population with imputation at month 60||%EWL||Standard Deviation|Mean
737162|NCT00447590|Primary|Percent of Subjects Who Attain Clinically Successful Weight Loss of ≥30% Excess Weight Loss (EWL) at 1 Year Post LAP-BAND Implantation.|"Percent Excess Weight Loss was defined as Weight Loss divided by Excess Weight multiplied by 100.
Excess Weight = baseline weight – ideal weight, where Ideal weight was determined using the 85th percentile on the Centers for Disease Control (CDC) Growth Charts for children and adolescents ages 2 to 20 years."|1 year|Intent to treat (ITT) population with imputation at month 12 (ITT population consisted of participants treated with the LAP-BAND).||percentage of participants|||Number
737163|NCT00447603|Secondary|Change From Baseline in Sitting Trough Diastolic Blood Pressure (SiDBP) at Week 4 of Double-blind Treatment Period||Baseline and Week 4|Full Analysis Set (FAS) Population, defined as all participants who were randomly assigned to a treatment arm for double-blind treatment period of study. This analysis was not done. The study was terminated before any participants were randomized to a treatment arm.|||||
737164|NCT00447603|Primary|Number of Participants Who Had Study Drug Discontinued Due to an Adverse Event During Double-blind Treatment Phase of Study||up to 4 weeks|All Participants as Treated (APaT) Population, defined as participants who were randomly assigned to a treatment arm and who received at least 1 dose of study therapy. Study terminated early; no participant entered treatment period of study.|||||
737165|NCT00447603|Primary|Number of Participants Who Experience an Adverse Event During Double-blind Treatment Phase of Study||up to 4 weeks|All Participants as Treated (APaT) Population, defined as participants who were randomly assigned to a treatment arm and who received at least 1 dose of study therapy. Study terminated early; no participant entered treatment period of study.|||||
737166|NCT00447603|Primary|Change From Baseline in Sitting Trough Systolic Blood Pressure (SiSBP) at Week 4 of Double-blind Treatment Period||Baseline and Week 4|Full Analysis Set (FAS) Population, defined as all participants who were randomly assigned to a treatment arm for double-blind treatment period of study. This analysis was not done. The study was terminated before any participants were randomized to a treatment arm.|||||
737167|NCT00447876|Secondary|Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit|A global assessment of the patient's current condition relative to baseline was performed by the patient at each visit using a 5 level scale: significantly better, slightly better, unchanged, slightly worse, significantly worse. The number of patients for each variable at each indicated timepoint are reported.|Baseline and Weeks 2, 6, 10, 14 and 18|The ITT analysis set was defined as the set of randomized patients who received study treatment and for whom values of the efficacy parameters were available at baseline and at least one later timepoint.||Number of participants|||Number
737168|NCT00447876|Secondary|Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit|A global assessment of the patient's current condition relative to baseline was performed by the Investigator at each visit using 5 level scale: significantly better, slightly better, unchanged, slightly worse, significantly worse. The number of patients for each variable at each indicated timepoint are reported.|Baseline and Weeks 2, 6, 10, 14 and 18|The ITT analysis set was defined as the set of randomized patients who received study treatment and for whom values of the efficacy parameters were available at baseline and at least one later timepoint.||Number of participants|||Number
737169|NCT00447876|Secondary|Assessment of Dorsal Extension / Plantar Flexion Range of Motion (ROM) of the Affected Foot At Week 18|Dorsal extension and plantar flexion of the affected foot were assessed at baseline and at Week 18. A ROM of approximately 70 degrees is considered to be normal. The LS means, adjusted for the baseline value are reported.|Baseline and Week 18|The ITT analysis set was defined as the set of randomized patients who received study treatment and for whom values of the efficacy parameters were available at baseline and at least one later timepoint. This variable was only analyzed for 34 patients (18 for Dysport® and 16 for Placebo) for whom ROM was determined at both baseline and Week 18.||Degrees||95% Confidence Interval|Least Squares Mean
737170|NCT00447876|Secondary|Assessment of Sum of Pressure Threshold Differences (by Measurement of AUC) for Overall Study|Assessments of the pressure threshold using an algometer (which corresponded to the minimum pressure causing pain) were performed at each visit. Pressure threshold differences at each timepoint were determined by comparison to baseline, followed by calculation of the AUC of the pressure threshold difference as a function of time. The LS means of AUC, adjusted for the baseline value of pressure threshold are reported.|Baseline and Weeks 2, 6, 10, 14 and 18|The ITT analysis set was defined as the set of randomized patients who received study treatment and for whom values of the efficacy parameters were available at baseline and at least one later timepoint. Missing values were replaced using the LOCF method.||(kg / cm^2) * day||95% Confidence Interval|Least Squares Mean
737171|NCT00447876|Secondary|Changes From Baseline in Pressure Threshold (With Algometer) at Each Visit|Pressure pain in the medial back foot was measured using an algometer. Pressure threshold corresponded to the minimum pressure causing pain. The changes from baseline, expressed as pressure threshold differences at each indicated timepoint are reported.|Baseline and Weeks 2, 6, 10, 14 and 18|The ITT analysis set was defined as the set of randomized patients who received study treatment and for whom values of the efficacy parameters were available at baseline and at least one later timepoint. Missing values were replaced using the LOCF method.||kg / cm^2||Standard Deviation|Mean
737172|NCT00447876|Secondary|Assessment of Sum of Pain Threshold Differences (by Measurement of AUC) for Overall Study|Assessments of the pain threshold using an algometer (which was the pressure corresponding to the maximum tolerated pain) were performed at each visit. Pain threshold differences at each timepoint were determined by comparison to baseline, followed by calculation of the AUC of the pain threshold difference as a function of time. The LS means of AUC, adjusted for the baseline value of pain threshold are reported.|Baseline and Weeks 2, 6, 10, 14 and 18|The ITT analysis set was defined as the set of randomized patients who received study treatment and for whom values of the efficacy parameters were available at baseline and at least one later timepoint. Missing values were replaced using the LOCF method.||(kg / cm^2) * day||95% Confidence Interval|Least Squares Mean
737173|NCT00447876|Secondary|Changes From Baseline in Pain Threshold at Each Visit|The maximum pain felt in the medial back foot was measured using an algometer. The pain threshold corresponded to the maximum pressure at which pain was still tolerated. Changes from baseline, expressed as pain threshold differences at each indicated timepoint are reported.|Baseline and Weeks 2, 6, 10, 14 and 18|The ITT analysis set was defined as the set of randomized patients who received study treatment and for whom values of the efficacy parameters were available at baseline and at least one later timepoint. Missing values were replaced using the LOCF method.||Kilogram (kg) / cm^2||Standard Deviation|Mean
737174|NCT00447876|Secondary|Assessment of SPID for Continuous Pain for Overall Study|Assessments of the pain intensity while at rest (continuous pain during the previous 48 hours) were performed by means of a 10 cm VAS (0 = no pain, 10 = maximum pain) at each visit. The PID values at each timepoint were determined by comparison to baseline, followed by calculation of the AUC of PID as a function of time (i.e. SPID). The LS means for SPID, adjusted for the baseline value of pain at rest are reported.|Baseline and Weeks 2, 6, 10, 14 and 18|The ITT analysis set was defined as the set of randomized patients who received study treatment and for whom values of the efficacy parameters were available at baseline and at least one later timepoint. Missing values were replaced using the LOCF method.||cm * day||95% Confidence Interval|Least Squares Mean
737175|NCT00447876|Secondary|Changes From Baseline in Continuous Pain (Pain At Rest) at Each Visit|Assessments of the pain intensity while at rest (continuous pain during the previous 48 hours) were performed by means of a 10 cm VAS (0 = no pain, 10 = maximum pain) at each visit. The changes from baseline, expressed as PID values at each indicated timepoint are reported.|Baseline and Weeks 2, 6, 10, 14 and 18|The ITT analysis set was defined as the set of randomized patients who received study treatment and for whom values of the efficacy parameters were available at baseline and at least one later timepoint. Missing values were replaced using the LOCF method.||cm||Standard Deviation|Mean
737176|NCT00447876|Secondary|Assessment of Sum of Pain Intensity Difference (SPID) for Maximum Pain for Overall Study|Assessments of the pain intensity while moving (maximum pain during the previous 48 hours) were performed by means of a 10 cm VAS (0 = no pain, 10 = maximum pain) at each visit. The PID values at each timepoint were determined by comparison to baseline, followed by calculation of the area under the curve (AUC) of PID as a function of time (i.e. SPID). The least square (LS) means of SPID, adjusted for the baseline value of pain while moving are reported.|Baseline and Weeks 2, 6, 10, 14 and 18|The ITT analysis set was defined as the set of randomized patients who received study treatment and for whom values of the efficacy parameters were available at baseline and at least one later timepoint. Missing values were replaced using the LOCF method.||cm * day||95% Confidence Interval|Least Squares Mean
737177|NCT00447876|Secondary|Changes From Baseline in Maximum Pain (Pain While Moving) at Each Visit|Assessments of the pain intensity while moving (maximum pain during the previous 48 hours) were performed by means of a 10 cm VAS (0 = no pain, 10 = maximum pain) at each visit. The changes from baseline, expressed as Pain Intensity Difference (PID) values at each indicated timepoint are reported.|Baseline and Weeks 2, 6, 10, 14 and 18|The ITT analysis set was defined as the set of randomized patients who received study treatment and for whom values of the efficacy parameters were available at baseline and at least one later timepoint. Missing values were replaced using the LOCF method.||Centimeter (cm)||Standard Deviation|Mean
737178|NCT00447876|Secondary|Changes From Baseline in Gerbershagen’s Score at Week 18|The Gerbershagen scale gives a global score ranging between I and III, with lower scores reflecting less impact of pain in terms of temporal, spatial aspects, drug taking behaviour and utilization of the health care system. The changes in Gerbershagen’s global scores from baseline to Week 18 are reported as percentage of patients for each of the specified categories.|Baseline and Week 18|The ITT analysis set was defined as the set of randomized patients who received study treatment and for whom values of the efficacy parameters were available at baseline and at least one later timepoint. This variable could only be analyzed for 30 patients (15 from each group) for whom the score could be determined both at baseline and at Week 18.||Percentage of participants|||Number
737179|NCT00447876|Primary|Responders Rate at Week 6 (Pain While Moving)|The responder rate was defined as the percentage of patients whose pain score while moving during the last 48 hours, measured by means of a 10 cm Visual Analogue Scale (VAS, 0 = no pain, 10 = maximum pain) decreased by at least 50% at Week 6 as compared to baseline. Pain at movement is the cardinal symptom of plantar fasciitis and the 10 cm VAS is a reference method for the assessment of pain intensity.|Baseline and Week 6|The Intention-To-Treat (ITT) analysis set was defined as the set of randomized patients who received study treatment and for whom values of the efficacy parameters were available at baseline and at least once at a later timepoint. Missing values were replaced using the last observation carried forward (LOCF) method.||Percentage of participants|||Number
737180|NCT00447902|Primary|The Primary Safety Endpoint Was the Occurrence of Dose-limiting Hepatotoxicity During the Study.|Dose-limiting hepatotoxicity was defined as Grade 4 ALT or AST elevation confirmed in 48h or any evocative symptoms or signs of hepatitis, if it not clearly attributable to another cause. Patients who experienced dose-limiting hepatotoxicity stopped TPV/r and were considered treatment failures for the analysis.|From the start of the study through 48 weeks.||||||
737181|NCT00447902|Secondary|Frequency of Patients (%) With Possible Clinically Significant Abnormalities of Laboratory Measurements|Frequency of patients (%) with possible clinically significant abnormalities of laboratory measurements (haematology, differentials (automatic and absolute), coagulation, electrolytes, enzymes, substrates, urinalysis, serology and T-cells)|Baseline through 48 weeks|||percentage of participants|||Number
737182|NCT00447902|Secondary|Post-dose Tipranavir (TPV) and Ritonavir (RTV) Concentrations at Week 4|Post-dose Tipranavir (TPV) and Ritonavir (RTV) plasma concentrations at Week 4|Week 4|The trial has been stopped due to a poor enrollment|||||
737183|NCT00447902|Secondary|Occurrence of Tipranavir (TPV) Trough Concentration >120 μM|Patients with TPV trough above 120 μM are at high risk of developing a Grade 3 or 4 ALT or AST elevations. The risk of Grade 3 or greater transaminase elevations appeared to be uniform at TPV trough concentration below 120 μM. Hence, for this study the TPV trough should be maintained below 120 μM.|After 2 weeks of treatment until the end of trial|The trial has been stopped due to a poor enrollment|||||
737184|NCT00447902|Secondary|Occurrence of Tipranavir (TPV) Inhibitory Quotient (IQ) >60 at Each Visit Where TPV Concentration is Measured|A high inhibitory quotient (IQ), the ratio of trough plasma drug concentration to the protein-adjusted viral IC50, is a useful indicator of the potential efficacy margin of antiretroviral drugs. The IQ for TPV is calculated by the formula IQ = TPV Ctrough / (3.75 x Z x fold change of the patients virus), where Z = wild type control IC50 IIIB.|After 2 weeks of treatment until the end of trial|The trial has been stopped due to a poor enrollment|||||
737185|NCT00447902|Secondary|Patients Adherence With Study Medication Based on Pill Count|number of pills actually taken divided by the planned number of pills the patient should take|After 4 weeks of treatment until the end of the trial|The trial has been stopped due to a poor enrollment|||||
737186|NCT00447902|Secondary|Tipranavir (TPV) and Ritonavir (RTV) Trough Concentrations at Week 2, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48|Tipranavir (TPV) and Ritonavir (RTV) trough concentrations from plasma samples at Week 2, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48|after 2 weeks of treatment till Week 48|The trial has been stopped due to a poor enrollment|||||
737187|NCT00447902|Secondary|Change in Ratio of CD3+ CD8+ CD38+ HLA DR From Baseline to Week 48.|Change from baseline to Week 48 for the ratio of CD3+ CD8+ CD38+ HLA DR . Samples were obtained for CD3+ CD8+ CD38+ HLA DR as measurements of viral suppression during antiretroviral therapy.|after 2 weeks of treatment till Week 48|The trial has been stopped due to a poor enrollment|||||
737188|NCT00447902|Secondary|Change in Ratio of CD38+/CD8+ From Baseline to Week 48|Change from baseline to Week 48 for the ratio of CD38+ to CD8+ cell counts. Samples were obtained for CD38+ and CD8+ as measurements of viral suppression during antiretroviral therapy.|after 2 weeks of treatment till Week 48|The trial has been stopped due to a poor enrollment|||||
737189|NCT00447902|Secondary|Change in CD4+ and CD8+ Cell Counts From Baseline to Week 48|Change from baseline to Week 48 for CD4+ and CD8+ cell counts. Samples were obtained for CD4+ and CD8+ as measurements of viral suppression during antiretroviral therapy.|after 2 weeks of treatment till Week 48|The trial has been stopped due to a poor enrollment|||||
737190|NCT00447902|Secondary|Time to New AIDS or AIDS Related Progression Event or Death|Time to new AIDS or AIDS related progression event or death as defined by AIDS defining and/or AIDS-related illnesses.|After Day 1 of treatment until the end of the trial|The trial has been stopped due to a poor enrollment|||||
737191|NCT00447902|Secondary|Time to Treatment Failure|For patients who never achieve a confirmed virologic response, time to treatment failure is defined as 0. For patients who achieve a confirmed virologic response, time to treatment failure is the earliest time of either: death, permanent discontinuation of the study drug or loss to follow-up, introduction of a new anti-retroviral drug to the regimen if it is not solely related to either toxicity or intolerance clearly attributable to a background drug, but not the study drug, or first occurrence of a VL >50 copies/mL at two consecutive measurements after having achieved a VL <50 copies/mL.|After Day 1 of treatment until the end of the trial|The trial has been stopped due to a poor enrollment|||||
737192|NCT00447902|Secondary|Change in Viral Load From Baseline at Each Visit|Change in viral load (measured from a plasma sample) from baseline at each visitPatients with a viral load of less than 400 copies/mL at each visit as .|After 4 weeks of treatment until the end of the trial|The trial has been stopped due to a poor enrollment|||||
737193|NCT00447902|Secondary|Occurrence of ≥1 log10 Drop in Viral Load From Baseline at All Visits, Including Visits at Weeks 24 and 48|Occurrence of greater than or equal to 1 log10 drop in viral load from baseline at all visits, including visits at Weeks 24 and 48|Baseline, 24 and 48 weeks|The trial has been stopped due to a poor enrollment|||||
737194|NCT00447902|Secondary|Occurrence of Viral Load Less Than 400 Copies/mL at Each Visit|Patients with a viral load of less than 400 copies/mL at each visit as measured from a plasma sample.|After 4 weeks of treatment until the end of the trial||||||
737195|NCT00447902|Secondary|Occurrence of Viral Load Less Than 400 Copies/mL at Weeks 24 and 48|Patients with a viral load of less than 400 copies/mL at Weeks 24 and 48 as measured from a plasma sample.|24 and 48 weeks|The trial has been stopped due to a poor enrollment|||||
737196|NCT00447902|Secondary|Virologic Response Defined as Viral Load <50 Copies/mL at Each Visit|Virologic response defined as viral load less than 50 copies/mL|After 4 weeks of treatment until the end of the trial|The trial has been stopped due to a poor enrollment|||||
737197|NCT00447902|Primary|Treatment Response at Week 48|Treatment response is a confirmed virologic response, defined as a viral load less than 50 copies/mL at two consecutive measurements at least 5 days apart, without death, permanent discontinuation, or introduction of a new antiretroviral|48 weeks|The trial has been stopped due to a poor enrollment|||||
737198|NCT00448019|Secondary|Overall Response Rate (ORR) to Fludarabine, Cyclophosphamide, Rituximab, and Bevacizumab Therapy in Previously Treated CLL|ORR defined as CR and PR response where response criteria for Complete response (CR) - Nodes: None; Liver/Spleen Size: Not palpable; Symptoms: None; polymorphonuclear leukocytes (PMN): >1,500/μl; Platelets >100,000/μl; Hemoglobin (untransfused): >11,0 g/dl; Lymphocytes: <4,000/μl; Bone Marrow aspirate: <30% lymphocytes; Biopsy: No lymphocyte infiltrate; and for Partial Response (PR), Nodes: >/= 50% decrease; Liver/Spleen Size: >/= 50% decrease; Symptoms: None; Platelets >100,000/μl or > 50% improvement from baseline; Hemoglobin (untransfused): >11.0 g/dl or >50% improvement from baseline; Lymphocytes: >50% decrease; Biopsy: <30% lymphocytes with residual disease on biopsy for nodular PR (NPR).|Response assessed after three 4-week courses and after six courses, up to 24 weeks|Five participants of the 62 treated participants were not evaluable for response.||percentage of participants|||Number
737208|NCT00448136|Secondary|OS - Time to Event|OS was defined as the time from the first treatment administration to death from any cause. Data for participants who were lost to follow-up were censored at the date of last evaluation. Data for participants who were alive at the end of the study were censored at the date of last visit. Median OS was estimated using the Kaplan-Meier method.|Screening, Day 1 of every cycle during treatment, every 6 months during follow-up to 2 years|ITT population||months||95% Confidence Interval|Median
737199|NCT00448019|Secondary|Number of Participants With Complete or Partial Response to Fludarabine, Cyclophosphamide, Rituximab, and Bevacizumab Therapy in Previously Treated Chronic Lymphocytic Leukemia (CLL)|Response criteria for Complete response (CR) - Nodes: None; Liver/Spleen Size: Not palpable; Symptoms: None; polymorphonuclear leukocytes (PMN): >1,500/μl; Platelets >100,000/μl; Hemoglobin (untransfused): >11,0 g/dl; Lymphocytes: <4,000/μl; Bone Marrow aspirate: <30% lymphocytes; Biopsy: No lymphocyte infiltrate; and for Partial Response (PR), Nodes: >/= 50% decrease; Liver/Spleen Size: >/= 50% decrease; Symptoms: None; Platelets >100,000/μl or > 50% improvement from baseline; Hemoglobin (untransfused): >11.0 g/dl or >50% improvement from baseline; Lymphocytes: >50% decrease; Biopsy: <30% lymphocytes with residual disease on biopsy for nodular PR (NPR).|Response assessed after three 4-week courses and after six courses, up to 24 weeks|Five participants of the 62 treated participants were not evaluable for response.||participants|||Number
737200|NCT00448019|Primary|Progression Free Survival (PFS) Rate|Progression free survival (PFS) was defined as the time from the start of treatment to progression, which included treatment failure, relapse, or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Baseline up to 5 years|Five participants of the 62 treated participants were not evaluable for response.||Months||Full Range|Median
737201|NCT00448123|Secondary|High Pain Score by Treatment Group|Severity of Patient Pain at 7 days Post Emergency Department Visit. Patients were asked to describe their pain severity at each followup phone call, using a numerical scale, ranging from 0 (no pain) to 10 (worst possible pain). We report this measure at 7 days.|7 Days|The data table is limited to the information collected at Day 7. Of the 53 subjects in the placebo group only 29 provided information at the Day 7 interview. For the Tamsulosin group, only 15 out of 47 provided information at the Day 7 interview.||units on a scale||Full Range|Mean
737202|NCT00448123|Secondary|Amount (Mean Number of Tablets Taken) of Pain Medication Taken by Subjects up to Seven (7) Days Post Emergency Department Discharge||1-7 days|The data table is limited to the information collected at Day 7. Of the 53 subjects in the placebo group only 29 provided information regarding pain medication at the Day 7 interview. For the Tamsulosin group, only 15 out of 47 provided the pain medication information at the Day 7 interview. At Day 7 each group had only 3 non-zero responses.||Pain tablets||Full Range|Mean
737203|NCT00448123|Primary|Stone Passage|Participants were asked during the follow-up phone call to indicate if their stone had passed within seven days. Phone calls were conducted at days 1, 2, 3, 7, 10 and 30 days after the emergency department discharge. Data is reported based on the information obtained up to the 7th day.|1-7 days|In the placebo group, of the 47 subjects 18 (46.2%) passed their stone by Day 7. In the Tamsulosin group, of the 53 subjects 21 (53.9%) passed their stone by Day 7.||participants|||Number
737204|NCT00448136|Secondary|EORTC QLQ-C30 Functional and Symptom Scale Scores|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale [1 'very poor' to 7 'Excellent']). Scores averaged, transformed to 0-100 scale; for functional scores, a higher score represents a better level of functioning. For symptom scale scores a higher level represents a more severe level of symptoms.|Screening, every 3 months during treatment|ITT population; only participants who completed the questionnaire at baseline and who had at least 1 post-baseline assessment were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.||units on a scale||Standard Deviation|Mean
737205|NCT00448136|Secondary|Percentage of Participants With Change From Baseline in Global Health Status by EORTC QLQ-C30 Improvement Category|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale [1 'very poor' to 7 'Excellent']). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms. Changes from baseline were categorized as follows: Very much worsening (less than [<]-20); Moderate worsening (greater than or equal to [≥]-20 to <-10); Little worsening (≥-10 to <-5); No change (≥-5 to less than or equal to [≤]5); Little improvement (>5 to ≤10); Moderate improvement (>10 to ≤20); and Very much improved (>20).|Screening, every 3 months during treatment|ITT population; only participants who completed the questionnaire at baseline and who had at least 1 post-baseline assessment were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
737206|NCT00448136|Secondary|Global Health Status as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - C30 (EORTC QLQ-C30)|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale [1 'very poor' to 7 'Excellent']). Scores were averaged and transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms.|Screening, every 3 months during treatment|ITT population; only participants who completed the questionnaire at baseline and who had at least 1 post-baseline assessment were included in the analysis. Number (n) equals (=) the number of participants assessed for the specified parameter at a given visit.||units on a scale||Standard Deviation|Mean
737207|NCT00448136|Secondary|OS - Percentage of Participants Surviving at 12 and 24 Months|OS was defined as the time from the first treatment administration to death from any cause. Data for participants who were lost to follow-up were censored at the date of last evaluation. Data for participants who were alive at the end of the study were censored at the date of last visit.|Screening, Day 1 of every cycle during treatment, every 6 months during follow-up to 2 years|ITT population.||percentage of participants|||Number
737262|NCT00448435|Secondary|Adjusted Mean Change From Baseline of Circadian Variation in Morning PEF(%) During the 4-week Treatment Periods|Mean change from baseline = value at each assessment period (mean of the values obtained at each assessment period [Weeks 1-4/Weeks 7-10]) minus baseline value. Baseline: Mean of the daily values over the last 7 days of the 2-week run-in/wash-out.|Crossover Period Weeks 1-4, 7-10|PPS||Percentage of circadian variation||Standard Error|Mean
737209|NCT00448136|Secondary|Overall Survival (OS) - Percentage of Participants With an Event|OS was defined as the time from the first treatment administration to death from any cause. Data for participants who were lost to follow-up were censored at the date of last evaluation. Data for participants who were alive at the end of the study were censored at the date of last visit.|Screening, Day 1 of every cycle during treatment, every 6 months during follow-up to 2 years|ITT population||percentage of participants|||Number
737210|NCT00448136|Secondary|Duration of ODC - Percentage of Participants Maintaining Disease Control at 12 and 24 Months|Duration of ODC was determined only for those participants with overall control disease (CR, PR, or SD per RECIST) and was defined as the time interval between the first occurrence of disease control (CR, PR, or SD) and the date of progression or death from any cause. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of progression or death were censored at the data of last visit or follow-up without progression.|Screening, every 3 months during treatment, every 6 months during follow-up to 2 years|ITT population; only participants with a response (CR, PR, or SD) were included in the analysis.||percentage of participants|||Number
737211|NCT00448136|Secondary|Duration of ODC - Time to Event|Determined only for those participants with overall control disease (CR, PR, or SD per RECIST) and was defined as the time interval between the first occurrence of disease control (CR, PR or SD) and the date of progression or death from any cause. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of progression or death were censored at the data of last visit or follow-up without progression. Median time to event was estimated using the Kaplan-Meier method.|Screening, every 3 months during treatment, every 6 months during follow-up to 2 years|ITT population; only participants with a response (CR, PR, or SD) were included in the analysis.||months||95% Confidence Interval|Median
737212|NCT00448136|Secondary|Duration of Overall Disease Control (ODC) - Percentage of Participants With an Event|Determined only for those participants with overall disease control (CR, PR or SD per RECIST) and was defined as the time interval between the first occurrence of disease control (CR, PR or SD) and the date of progression or death from any cause. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of progression or death were censored at the data of last visit or follow-up without progression.|Screening, every 3 months during treatment, every 6 months during follow-up to 2 years|ITT population||percentage of participants|||Number
737213|NCT00448136|Secondary|Duration of OR - Percentage of Participants With Sustained Response at 12 and 24 Months|Duration of OR was determined only for those participants with an overall response of CR or PR and was defined as the time interval between the response (CR or PR) and the date of progression or death from any cause. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of progression or death were censored at the data of last visit or follow-up without progression.|Screening, every 3 months during treatment, every 6 months during follow-up to 2 years|ITT population||percentage of participants|||Number
737214|NCT00448136|Secondary|Duration of OR - Time to Event|Determined only for those participants with an overall response (CR or PR) and was defined as the time interval between the response (CR or PR) and the date of progression or death from any cause. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of progression or death were censored at the data of last visit or follow-up without progression. Median duration of OR was estimated using the Kaplan-Meier method.|Screening, every 3 months during treatment, every 6 months during follow-up to 2 years|ITT population; only participants with a response of CR or PR were included in the analysis.||months||95% Confidence Interval|Median
737215|NCT00448136|Primary|PFS - Percentage of Participants Estimated to be Progression Free at 12 and 24 Months|PFS is defined as the interval between the date of start of treatment and the date of evaluation by the investigator of progressive disease or death from any cause. The progression was assessed according to RECIST using medical imaging during the treatment period and by the investigators (confirmed by medical imaging) during the follow-up period. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of disease progression or death were censored at the date of the last visit or follow-up without progression.|Screening, every 3 months during treatment, every 6 months during follow-up to 2 years|ITT population||percentage of participants|||Number
737216|NCT00448136|Primary|PFS - Time to Event|PFS is defined as the interval between the date of start of treatment and the date of evaluation by the investigator of progressive disease or death from any cause. The progression was assessed according to RECIST using medical imaging during the treatment period and by the investigators (confirmed by medical imaging) during the follow-up period. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of disease progression or death were censored at the date of the last visit or follow-up without progression. Median PFS was estimated using the Kaplan-Meier method.|Screening, every 3 months during treatment, every 6 months during follow-up to 2 years|ITT population||months||95% Confidence Interval|Median
737217|NCT00448136|Secondary|Duration of Overall Response (OR) - Percentage of Participants With an Event|Determined only for those participants with an overall response (CR or PR) and was defined as the time interval between the response (CR or PR) and the date of progression or death from any cause. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of progression or death were censored at the data of last visit or follow-up without progression.|Screening, every 3 months during treatment, every 6 months during follow-up to 2 years|ITT population; only participants with a response of CR or PR were included in the analysis.||percentage of participants|||Number
737263|NCT00448435|Secondary|Adjusted Mean Change From Baseline in Evening PEF During the 4-week Treatment Periods|Mean change from baseline = value at each assessment period (mean of the values obtained at each assessment period [Weeks 1-4/Weeks 7-10]) minus baseline value. Baseline: Mean of the daily values over the last 7 days of the 2-week run-in/wash-out.|Crossover Period weeks 1-4, 7-10|PPS||L/min||Standard Error|Mean
737218|NCT00448136|Secondary|Percentage of Participants With a Response by Best Overall Response|Best overall response defined as best response recorded during the study as defined according to RECIST; performed by the investigator and by centralized review. Complete response (CR): complete disappearance of all target lesions and non-target disease. All lesions, both target and non-target, must have decreased to normal (short axis, less than [<]10 millimeters [mm]). No new lesions. Partial response (PR): greater than or equal to (≥)30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter (LD) was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. Stable disease (SD): not qualifying for CR, PR, or Progressive Disease (PD). PD: at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.|Screening, every 3 months during treatment, every 6 months during follow-up to 2 years|ITT population. Data were missing from centralized review for 1 participant.||percentage of participants||95% Confidence Interval|Number
737219|NCT00448136|Primary|Progression-Free Survival (PFS) - Percentage of Participants With an Event|PFS is defined as the interval between the date of start of treatment and the date of evaluation by the investigator of progressive disease or death from any cause. The progression was assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) using medical imaging during the treatment period and by the investigators (confirmed by medical imaging) during the follow-up period. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of disease progression or death were censored at the date of the last visit or follow-up without progression.|Screening, every 3 months during treatment, every 6 months during follow-up to 2 years|ITT population||percentage of participants|||Number
737220|NCT00448175|Secondary|Known Side Effects Through 12 Weeks||12 weeks||||||
737221|NCT00448175|Secondary|OAB Quality of Life at 12 Weeks||12 weeks||||||
737222|NCT00448175|Secondary|Volume Voided at 12 Weeks||12 weeks||||||
737223|NCT00448175|Secondary|Urge Incontinence Episodes at 12 Weeks||12 weeks||||||
737224|NCT00448175|Primary|Frequency of Voids at 12 Weeks|To demonstrate that the Urgent PC system is as effective as or more effective (noninferior) than tolterodine (Detrol LA) in changing the frequency of urinary voids per day after 12 weeks of therapy. The voiding diaries completed at 12 weeks were compared to the baseline voiding diaries.|Baseline to 12 weeks|||Voids/day||Standard Deviation|Mean
737225|NCT00448201|Secondary|Graft-vs-host Disease at 6 Months Post-transplant|"Graft-vs-host disease (GVHD) can be mild, moderate or severe depending on the differences in tissue type between patient and donor. Its symptoms can include:
Rashes, which include burning and redness, that erupt on the palms or soles and may spread to the trunk and eventually to the entire body
Blistering, causing the exposed skin surface to flake off in severe cases
Nausea, vomiting, abdominal cramps, diarrhea and loss of appetite, which can indicate that the gastrointestinal (digestive) tract is affected
Jaundice, or a yellowing of the skin, which can indicate liver damage
Excessive dryness of the mouth and throat, leading to ulcers
Dryness of the lungs, vagina and other surfaces
Acute GVHD - Can occur soon after the transplanted cells begin to appear in the recipient. Acute GVHD ranges from mild, moderate or severe, and can be life-threatening if its effects are not controlled.
Extensive chronic GVHD - Usually occurs at about three months post-transplant."|6 Months|||percentage of participants|||Number
737226|NCT00448201|Secondary|5-year Disease-free Survival|The length of time post-transplant that the patient survives without any signs or symptoms of that cancer.|Year 5|||percentage of participants|||Number
737227|NCT00448201|Secondary|Complete or Mixed Donor Chimerism at 30, 60, and 90 Days Post-transplant|"Complete chimerism is defined as 100% donor cells detected, suggesting complete hematopoietic replacement. Mixed donor chimerism means host cells are detected in particular cells like lymphocytes. Five to 90% donor cells set the criteria for mixed chimerism (MC).
Chimerism was not tabulated on day 30."|Days 30, 60, and 90|||percentage of patients|||Number
737228|NCT00448201|Secondary|Complete Response at 6 and 12 Months Post-transplant||6 and 12 months|Complete response was not calculated at 6 and 12 months because the majority of patients had complete response at the time of transplant.|||||
737229|NCT00448201|Primary|Treatment-related Mortality|Treatment related mortality for first 6 months. Defined as the number of treatment related deaths excluding deaths due to disease relapse.|6 months|||percentage of participants|||Number
737230|NCT00448227|Secondary|Acceptability of the Famciclovir Pediatric Formulation as Assessed by Study Personnel|"Assessed by the study personnel using a 5-point scale after dosing:
Very badly accepted/unacceptable: infant showed great displeasure, compromising use of formulation
Badly but accepted: infant showed displeasure with dosing but could be coaxed to take complete dose
Neither good nor bad: infant showed no apparent displeasure and with little effort was coaxed to take complete dose
Well accepted: infant appeared to enjoy the formulation and with little coaxing ingested most of dose
Very well accepted: infant appeared eager and ingested most of dose without special coaxing"|Immediately after dosing|Safety population.||Participants|||Number
737231|NCT00448227|Primary|Pharmacokinetics of Single Dose - AUC(0-6h)|Measured by AUC(0-6h) - Area under the plasma concentration time curve from time zero up to 6 hours post dose (i.e. the time of the last sample).|Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing.|Analysis population included the intent-to-treat population, with the exception of one patient in the 1 to <3 months age group who did not have PK samples taken due to emesis reported after study medication administration.||(μg/mL)•h||Standard Deviation|Mean
737232|NCT00448227|Primary|Pharmacokinetics of Single Dose - AUC(0-tlast)|Measured by AUC(0-tlast) - Area under the plasma concentration time curve from time zero to the last quantifiable concentration-timepoint.|Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing.|Analysis population included the intent-to-treat population, with the exception of one patient in the 1 to <3 months age group who did not have PK samples taken due to emesis reported after study medication administration.||(μg/mL)•h||Standard Deviation|Mean
737233|NCT00448227|Primary|Pharmacokinetics of Single Dose - Cmax|Measured by Cmax - The maximum plasma concentration of study medication|Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing.|Analysis population included the intent-to-treat population, with the exception of one patient in the 1 to <3 months age group who did not have PK samples taken due to emesis reported after study medication administration.||μg/mL||Standard Deviation|Mean
737234|NCT00448227|Secondary|Acceptability of the Famciclovir Pediatric Formulation as Assessed by the Patient's Caregiver|"Assessed by the caregiver using a 5-point scale immediately after dosing:
Very badly accepted/unacceptable: infant showed great displeasure, compromising use of formulation
Badly but accepted: infant showed displeasure with dosing but could be coaxed to take complete dose
Neither good nor bad: infant showed no apparent displeasure and with little effort was coaxed to take complete dose
Well accepted: infant appeared to enjoy the formulation and with little coaxing ingested most of dose
Very well accepted: infant appeared eager and ingested most of dose without special coaxing"|Immediately after dosing|Safety population.||Participants|||Number
737235|NCT00448227|Secondary|Tolerability of of the Famciclovir Pediatric Formulation as Assessed by Study Personnel.|"Tolerability was assessed by the study personnel 30 minutes after dosing using the following scale:
Significant emesis occurred,
Infant spit out most of the dose ingesting less than half of what was administered,
Infant spit out some of the dose, but ingested at least 50% of what was administered,
Infant was able to ingest and retain the dose administered"|30 minutes after dosing|Safety population.||Participants|||Number
737236|NCT00448227|Secondary|Safety Assessed by Labs|Samples for safety labs were obtained at baseline and Day 2 visit and samples were analyzed by local accredited laboratory.|2 days||||||
737237|NCT00448227|Secondary|Safety Assessed by AEs, SAEs|AEs and SAEs were collected during patient's stay in the clinic for PK sampling up to Hour 8, then at day 2 visit, 8 days(safety follow-up call) and 38 days (safety follow-up call) post dose.|38 days||||||
737238|NCT00448227|Primary|Pharmacokinetics of Single Dose - Tmax|Measured by Tmax - The time after administration of a drug when the maximum plasma concentration is reached.|Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing.|Analysis population included the intent-to-treat population, with the exception of one patient in the 1 to <3 months age group who did not have PK samples taken due to emesis reported after study medication administration.||hours||Full Range|Median
737239|NCT00448279|Secondary|Percentage of Participants With a Best Overall Response of CR or PR|BOR was defined as the best objective response observed during the treatment period according to RECIST version 1.1. CR: disappearance of all TLs, with any pathological lymph nodes (whether target or non-target) having a reduction in short axis to less than 10 mm. PR: at least a 30% decrease in the sum of diameters of TLs, taking as reference the BL sum diameters. PD: at least a 20% increase in the sum of diameters of TLs, taking as a reference the smallest sum on study (this included the BL sum if that is the smallest on study). In addition to the relative increase in 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. SD: neither sufficient shrinkages to qualify for PR, nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|BL and every 8 weeks thereafter|ITT population||percentage of participants||95% Confidence Interval|Number
737240|NCT00448279|Secondary|Percentage of Participants by Best Overall Response (BOR)|BOR was defined as the best objective response observed during the treatment period according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Complete response (CR): disappearance of all target lesions (TLs), with any pathological lymph nodes (whether target or non-target) having a reduction in short axis to less than 10 millimeters (mm). Partial response (PR): at least a 30 percent (%) decrease in the sum of diameters of TLs, taking as reference the BL sum diameters. Progressive disease (PD): at least a 20% increase in the sum of diameters of TLs, taking as a reference the smallest sum on study (this included the BL sum if that is the smallest on study). In addition to the relative increase in 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. Stable disease (SD) was defined as neither sufficient shrinkages to qualify for PR, nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|BL and every 8 weeks thereafter|ITT population||percentage of participants|||Number
737241|NCT00448279|Secondary|Overall Survival - Time to Event|The median time from randomization to OS event. Participants were censored at the last contact date at which the participant was known to be alive.|BL and every 8 weeks thereafter|ITT population||months||95% Confidence Interval|Median
737242|NCT00448279|Secondary|Overall Survival (OS) - Percentage of Participants With an Event|OS was defined as the time from randomization to the date of death from any cause. Participants were censored at the last contact date at which the participant was known to be alive.|BL and every 8 weeks thereafter|ITT population||percentage of participants|||Number
737243|NCT00448279|Primary|Progression-Free Survival - Time to Event|The median time from randomization to PFS event. Participants were censored at the last tumour evaluation.|BL and every 8 weeks thereafter|ITT population||months||95% Confidence Interval|Median
737244|NCT00448279|Primary|Progression-Free Survival (PFS) - Percentage of Participants With an Event|PFS was defined as the time from randomization to the date of documented disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or the date of occurrence of a second primary cancer, or date of death from any cause, whichever comes first. Participants were censored at the last tumour evaluation.|Baseline (BL) and every 8 weeks thereafter|ITT population||percentage of participants|||Number
737245|NCT00448344|Secondary|The Impact of a Family-supported Intervention on Abstinence at 12-month Follow-up|self-reported 7- day point prevalent abstinence|12-months follow-up|||percentage of participants that quit|||Number
737246|NCT00448344|Primary|The Impact of a Family-supported Intervention on Rates of Abstinence From Cigarettes Compared to a Standard Intervention|self-reported 7-day point prevalent abstinence|5 months|||percentage of participants that quit|||Number
737247|NCT00448357|Secondary|Overall Survival|Percentage of participants alive at 3 years post transplant|Three years post-transplant|Because AUC levels varied between the groups and the goal was to identify an actual achieved AUC-based dose, additional outcome analyses were undertaken by dividing patients into thirds according to the actual AUCs delivered rather than the original planned AUCs.||percentage of participants|||Number
737248|NCT00448357|Secondary|Incidence of DNA Chimerism in Patients Between One Month Post Transplant|Deoxyribonucleic acid (DNA) chimerism is a measure identifying the genetic profiles of the transplant recipient and of the donor and then evaluating the extent of mixture in the recipient’s blood, bone marrow, or other tissue.|30 days post transplant|Because there were no differences in chimerism results as a function of either the immunosuppression used or busulfan dose received, the results are being reported only for the total population.||Participants|||Count of Participants
737249|NCT00448357|Secondary|Incidence of Graft vs Host Disease in Patients Between One Month and Two Years Post Transplant|"GVHD can be mild, moderate or severe depending on the differences in tissue type between patient and donor. GVHD can be acute or chronic. Its symptoms can include:
Rashes, which include burning and redness, that erupt on the palms or soles and may spread to the trunk and eventually to the entire body
Blistering, causing the exposed skin surface to flake off in severe cases
Nausea, vomiting, abdominal cramps, diarrhea and loss of appetite, which can indicate that the gastrointestinal (digestive) tract is affected
Jaundice, or a yellowing of the skin, which can indicate liver damage
Excessive dryness of the mouth and throat, leading to ulcers
Dryness of the lungs, vagina and other surfaces"|100 days post transplant|Because AUC levels varied between the groups and the goal was to identify an actual achieved AUC-based dose, additional outcome analyses were undertaken by dividing patients into thirds according to the actual AUCs delivered rather than the original planned AUCs.||Participants|||Count of Participants
737250|NCT00448357|Secondary|Capacity of Test Dosing of Busulfan That Would Result in the Desired Area Under the Curve Concentration Exposure of Patients Receiving a Full-dose Busulfan Regimen|Test doses of busulfan were administered and plasma levels were measured to determine a targeted AUC dosing estimate. The capacity is reported as the precision with which these test dose goals predicted the actual 90-hour mean AUC levels.Dose targeting precision was estimated by root mean squared error.|Day -15 to Day -11|||percentage of error|||Number
737251|NCT00448357|Primary|Number of Participants With Dose Limiting Toxicities (DLTs)|Dose limiting toxicity will be defined as any irreversible grade 3 or any grade 4 non-hematologic toxicity that is related to busulfan infusion and not graft vs host disease or late infection after recovery from the initial period of myelosuppression. The maximum tolerated dose (MTD) is defined as the dose with probability of dose limiting toxicity (DLT) of 0.25. The dose of continuous infusion IV busulfan based on blood levels derived from a test dose in conjunction with fludarabine and alemtuzumab plus tacrolimus for GVHD prophylaxis.|first 6 weeks or 42 days following stem cell infusion|||DLTs|||Number
737252|NCT00448357|Primary|Three-year Relapse-free Survival (RFS) Rate at the Maximum Tolerated Dose Identified During Phase I of the Trial (Target AUC 6912)|Relapse is defined as new or increased sites of disease or positive one marrow after a complete response (CR). The RFS was calculated as the percentage of patients who were alive and without relapse at 3 years|Three years post-transplant|Because AUC levels varied between the groups and the goal was to identify an actual achieved AUC-based dose, additional outcome analyses were undertaken by dividing patients into thirds according to the actual AUCs delivered rather than the original planned AUCs.||percentage of participants|||Number
737253|NCT00448435|Secondary|Percentage of Subjects With Rescue Medication-Free Nights & Days After 20 Weeks of Treatment|Percentage of subjects with Rescue Medication Free Nights & Days after 20 weeks of Treatment (at week 30).|Extension Period Weeks 11-30|FAS (Full Analysis Set) during the Extension period: all subjects switched to Extension period and received GW815SF HFA MDI.||Percentage of participants|||Number
737254|NCT00448435|Secondary|Percentage of Subjects With Symptom-Free Nights & Days After 20 Weeks of Treatment|Percentage of subjects with Symptom Free Nights & Days after 20 weeks of Treatment (at week 30).|Extension Period Weeks 11-30|FAS (Full Analysis Set) during the Extension period: all subjects switched to Extension period and received GW815SF HFA MDI.||Percentage of participants|||Number
737255|NCT00448435|Secondary|Adjusted Mean Change From Baseline of Circadian Variation in PEF(%) During the 20-Week Extension Treatment Period|Mean change from baseline = value at assessment period (mean of the values obtained at assessment period [Weeks 11-30]) minus baseline value. Baseline: Mean of the daily values over the last 7 days prior to the day of starting the Extension period (Weeks 11-30).|Extension Period weeks 11-30|FAS (Full Analysis Set) during the Extension period: all subjects switched to Extension period and received GW815SF HFA MDI.||Percentage of circadian variation||Standard Deviation|Mean
737256|NCT00448435|Secondary|Adjusted Mean Change From Baseline in Evening PEF During the 20-week Extension Treatment Period|Mean change from baseline = value at assessment period (mean of the values obtained at assessment period [Weeks 11-30]) minus baseline value. Baseline: Mean of the daily values over the last 7 days prior to the day of starting the Extension period (Weeks 11-30).|Extension Period weeks 11-30|FAS (Full Analysis Set) during the Exension period: all subjects switched to Extension period and received GW815SF HFA MDI.||L/Min||Standard Deviation|Mean
737257|NCT00448435|Secondary|Adjusted Mean Change From Baseline in Percent Personal Best Morning PEF(%) During the 20-week Extension Treatment Period|Mean change from baseline = value at assessment period (mean of the values obtained at assessment period [Weeks 11-30]) minus baseline value. Baseline: Mean of the daily values over the last 7 days prior to the day of starting the Extension period (Weeks 11-30).|Extension Period weeks 11-30|FAS (Full Analysis Set) during the Extension period: all subjects switched to Extension period and received GW815SF HFA MDI.||Percentage of personal best value||Standard Deviation|Mean
737258|NCT00448435|Secondary|Adjusted Mean Change From Baseline in Percent Predicted Morning PEF(%) During the 20-Week Extension Treatment Period|Mean change from baseline = value at assessment period (mean of the values obtained at assessment period [Weeks 11-30]) minus baseline value. Baseline: Mean of the daily values over the last 7 days prior to the day of starting the Extension period (Weeks 11-30).|Extension Period weeks 11-30|FAS (Full Analysis Set) during the Extension period: all subjects switched to Extension period and received GW815SF HFA MDI.||Percentage of predicted value||Standard Deviation|Mean
737259|NCT00448435|Secondary|Adjusted Mean Change From Baseline in Morning PEF During the 20-week Extension Treatment Period|Mean change from baseline = value at assessment period (mean of the values obtained at assessment period (Weeks 11-30).) minus baseline value. Baseline: Mean of the daily values over the last 7 days prior to the day of starting of the Extension period (Weeks 11-30).|Extension Period Weeks 11-30|FAS (Full Analysis Set) during the Extension period: all subjects switched to Extension period and received GW815SF HFA MDI.||L/min||Standard Deviation|Mean
737260|NCT00448435|Secondary|Percentage of Subjects With Rescue Medication-Free Nights and Days|Percentage of subjects with Rescue Medication Free Nights & Days after 4 weeks of Treatment|Crossover Period Weeks 1-4, 7-10|PPS||Percentage of participants|||Number
737261|NCT00448435|Secondary|Percentage of Subjects With Symptom-Free Nights & Days|Percentage of subjects with Symptom Free Nights & Days after 4 weeks of Treatment|Crossover Period Week 1-4, 7-10|PPS||Percent of participants|||Number
738780|NCT00458211|Secondary|Simpson-Angus Scale Measures Drug Induced Parkinsonism|Measures 10 signs, (not all of which are now considered Parkinsonism), minimum score 0 (no Parkinsonism) maximum 40.|8 weeks|see PANNS above||score on scale||Standard Deviation|Mean
737264|NCT00448435|Secondary|Adjusted Mean Change From Baseline in Percent Personal Best Morning PEF(%) During the 4-week Treatment Periods|Mean change from baseline = value at each assessment period (mean of the values obtained at each assessment period [Weeks 1-4/Weeks 7-10]) minus baseline value. Baseline: Mean of the daily values over the last 7 days of the 2-week run-in/wash-out.|Crossover Period weeks 1-4, 7-10|PPS||Percentage of personal best value||Standard Error|Mean
737265|NCT00448435|Secondary|Adjusted Mean Change From Baseline in Percent Predicted Morning PEF(%) During the 4-week Treatment Periods|Mean change from baseline = value at each assessment period (mean of the values obtained at each assessment period [Weeks 1-4/Weeks 7-10]) minus baseline value. Baseline: Mean of the daily values over the last 7 days of the 2-week run-in/wash-out.|Crossover Period Weeks 1-4, 7-10|PPS||Percentage of predicted value||Standard Error|Mean
737266|NCT00448435|Primary|Adjusted Mean Change From Baseline in Morning PEF (Peak Expiratory Flow) During the 4-week Treatment Periods|Mean change from baseline = value at each assessment period (mean of the values obtained at each assessment period [Weeks 1-4/Weeks 7-10]) minus baseline value. Baseline: Mean of the daily values over the last 7 days of the 2-week run-in/wash-out (i.e., the last 7 days prior to the day of starting treatment period [Weeks 1-4/Weeks 7-10]).|Crossover Period Weeks 1-4, and 7-10|PPS (Per Protocol Set): randomized subjects less those who did not complete treatment.||Liters/minute||Standard Error|Mean
737267|NCT00448448|Primary|Skeletal Maturity With a Cobb Angle of <50 Degrees (Successful Outcome)||Skeletal maturity and the Cobb angle were measured at baseline and at each 6-month follow-up. Subjects were followed until they reached criteria for either success or failure. The average duration of follow-up was 23.67 months.|The primary analysis included all patients who had completed the trial by January 2013, including 116 patients from the randomized arm and 126 from the preference arm.||percentage of patient successes|||Number
737268|NCT00448539|Primary|Percentage Change in Total Partial Seizure Frequency Per 28 Days Relative to the Baseline Phase|"Seizure data was collected via patient diaries. OL refers to open-label."|Baseline, Titration Phase (Days 1 to 18), Maintenance Phase|Intent-to-treat (ITT) population: All subjects who completed titration to open-label medication||Percentage change||Full Range|Median
737269|NCT00448591|Primary|Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) Related to Bevacizumab, Death, and AEs of Special Interest (AESIs)|Adverse events (including laboratory abnormalities) were assessed by the investigator according to the National Cancer Institute - Common Toxicity Criteria (NCI-CTC) grading systems.|Day 1 of Cycles 1, 2, 3, 4, 5, and 6 up to 6 months after the last bevacizumab infusion|Safety Population||percentage of participants|||Number
737270|NCT00448591|Secondary|Percentage of Participants by Best Overall Response to Treatment|Best overall response is defined as the best response shown throughout the study. Tumor assessment was performed by the investigator using standard clinical practice.|Baseline, Day 1 of Cycle 4, final visit and every 3 months during follow-up until disease progression or death up to 45 months|ITT Population||percentage of participants|||Number
737271|NCT00448591|Secondary|Overall Survival|Overall Survival was defined as the time from start of first-line therapy to death due to any cause. Participants for whom no death was captured in the clinical database were censored at the last date they were known to be alive. Median time to overall survival was calculated by Kaplan Meier estimates.|Baseline, Day 1 of Cycle 4, Final Visit and every 3 months during follow-up until death up to 45 months|ITT Population||months||Full Range|Median
737272|NCT00448591|Secondary|Percentage of Participants With Recorded Death||Baseline, Day 1 of Cycle 4, final visit and every 3 months during follow-up until disease progression or death up to 45 months|ITT Population||percentage of participants|||Number
737273|NCT00448591|Secondary|Time to Progression (TTP)|TTP was defined as the time period from the start of first-line therapy to investigator-assessed disease progression. Tumor assessments were performed according to standard clinical practice using NCI criteria. Participants who had not progressed at the time of analysis (including those who died before progressive disease [PD]) or who were lost to follow-up were censored at the last bevacizumab administration date. Time to disease progression was determined by Kaplan-Meier estimates.|Baseline, Day 1 of Cycle 4, final visit and every 3 months during follow-up until disease progression or death up to 45 months|ITT Population||months||Full Range|Median
737274|NCT00448591|Secondary|Percentage of Participants With Disease Progression|Disease progression was assessed by the investigator per standard clinical practice using Response Evaluation Criteria In Solid Tumors (RECIST) criteria.|Baseline, Day 1 of Cycle 4, final visit and every 3 months during follow-up until disease progression or death up to 45 months|ITT Population||percentage of participants|||Number
737275|NCT00448630|Secondary|Metabolic Syndrome Parameter Triglycerides by Treatment Group|Iterative measurement of triglycerides. Mean at time points.|Baseline, 1 Month, 4 Months|Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.||mg/dl||Standard Deviation|Mean
737276|NCT00448630|Secondary|Metabolic Syndrome Parameter Waist Circumference by Treatment Group|Iterative measurement of waist circumference. Mean at time points.|Baseline, 1 Month, 4 Months|Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.||cm (centimeter)||Standard Deviation|Mean
737277|NCT00448630|Secondary|Metabolic Syndrome Parameter Weight by Treatment Group|Iterative measurement of weight. Mean at time points.|Baseline, 1 Month, 4 Months|Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.||kg||Standard Deviation|Mean
737278|NCT00448630|Primary|Metabolic Syndrome Parameter Triglycerides|Iterative measurement of triglycerides. Mean at time points|Baseline, 1 Month, 4 Months|Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.||mg/dl||Standard Deviation|Mean
737279|NCT00448630|Primary|Metabolic Syndrome Parameter High Density Lipoprotein (HDL)|Iterative measurement of HDL. Mean at time points|Baseline, 1 Month, 4 Months|Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.||mg/dl||Standard Deviation|Mean
737280|NCT00448630|Primary|Metabolic Syndrome Parameter Low Density Lipoprotein (LDL)|Iterative measurement of LDL. Mean at time points|Baseline, 1 Month, 4 Months|Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.||mg/dl||Standard Deviation|Mean
737281|NCT00448630|Primary|Metabolic Syndrome Parameter Total Cholesterol|Iterative measurement of total cholesterol. Mean at time points.|Baseline, 1 Month, 4 Months|Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.||mg/dl||Standard Deviation|Mean
737288|NCT00448682|Secondary|Overall Rate of Survival|Patients will be followed for overall survival from date of enrollment to date of death or last contact. The extent of follow up will be described by the range and median for deceased patients and for those alive at last follow up. We will estimate the 1 year survival rates by the Kaplan-Meier method.|1 year|The study data has not been analyzed.|||||
737289|NCT00448682|Primary|Number of Patients Achieving Clinical Response|Number of patients achieving complete response (CR) or partial response (PR) according to RECIST Criteria version 1.0.|1 year|The study data has not been analyzed.|||||
737290|NCT00448708|Secondary|Adverse Events|adverse events with at least 5% incidence, reported as number of subjects experiencing the event (rather than total number of events). Adverse events were collected via subject querying at each visit and telephone contact, and by medical record review.|1 year|||participants|||Number
737291|NCT00448708|Primary|Time-to-loss of Target Site Primary Patency|"Subjects had primary patency at the target site from graft placement until an intervention on the target site occurred. The duration between graft implantation and graft abandonment due to loss of patency at the target site was the time-to-loss of primary patency. Note: The study was halted early and therefore became underpowered to analyze efficacy as detailed in the protocol."|1 year|||days||95% Confidence Interval|Median
737292|NCT00448760|Secondary|Overall Survival||24 months|||months||95% Confidence Interval|Median
737293|NCT00448760|Secondary|Median Progression-free Survival (PFS)||24 months|||months||95% Confidence Interval|Median
737294|NCT00448760|Secondary|Clinical Response|"Overall response = Complete response (CR) + Partial Response (PR). Evaluated via endoscopic ultrasounds, PET and CT scans of the chest:
Complete Response (CR) applies to participants complete disappearance of all measurable and evaluable disease. No new lesion. No disease related symptoms. No evidence of non-evaluable disease, including tumor markers and other laboratory values.
Partial Response (PR) applies to participants with at least 50 percent reduction in the sum of the products of bi-dimensional perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions."|8 - 16 weeks|||percentage of participants||90% Confidence Interval|Number
737295|NCT00448760|Primary|Pathologic Complete Response|No evidence of cellular residual cancerous cells as evidenced by tumor tissue samples taken via surgery at the end of neo-adjuvant chemotherapy.|8 - 16 weeks|||percentage of participants||90% Confidence Interval|Number
737296|NCT00448864|Secondary|Pharmacokinetics: Area Under the Concentration Time Curve|Results are reported in terms of the Area Under Plasma Concentration Time Curve (AUC), measured as milligram hour per liter (mg*h/L)|1, 2, 4, and 8 hours after end of study drug infusion|All participants who received at least 1 dose of study drug.||mg*h/L||Standard Deviation|Mean
737297|NCT00448864|Secondary|Number of Participants With Treatment-emergent Adverse Events|A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|up to 28 days post admission to ICU|All participants who received at least 1 dose of study drug.||participants|||Number
737298|NCT00448864|Secondary|Cumulative Chest Tube Drainage at 24 Hours Postoperatively|Mean volume of chest tube drainage during the first 24 hours postoperatively or until chest tube removal, whichever occurred first, is presented for each treatment group.|Up to 24 hours post admission to ICU|All participants who received at least 1 dose of study drug.||Milliliters||Standard Deviation|Mean
737299|NCT00448864|Primary|Cumulative Chest Tube Drainage During the First 12 Hours Postoperatively|Mean volume of chest tube drainage during the first 12 hours postoperatively or until chest tube removal, whichever occurred first, is presented for each treatment group.|Up to 12 hours post admission to intensive care unit (ICU)|All participants who received at least 1 dose of study drug.||Milliliters||Standard Deviation|Mean
737300|NCT00448916|Secondary|Number of Participants With Abnormalities in Chemistry (Including Liver Function, Renal Function, Lipids, Electrolytes, Glucose, Insulin Like Growth Factor (IGF) and IGF Binding Protein).|Based on criteria for safety values of potential clinical concern, the participants with abnormal values in liver function tests, renal function tests, lipid profile, electrolytes, glucose, Insulin like growth factor (IGF) and IGF binding protein were noted and reported in this section.|12 Months|Safety analysis set: All participants who received at least one dose of study medication were included.||Participants|||Number
737301|NCT00448916|Secondary|Seizure Frequency.|Twenty-eight-day seizure frequencies were to be calculated from the seizure diaries and were to be reviewed. However, due to the nature of the data collection and due to unability to clearly differentiate no seizures versus seizures, accurate computation of this data was not performed. Hence, the seizure data was reported as AE.|28 Days|Safety analysis set: All participants who received at least one dose of study medication were included.||Participants|||Number
737302|NCT00448916|Secondary|Number of Participants With Abnormalities in Creatine Kinase.|Based on criteria for safety values of potential clinical concern, the participants with abnormal values in creatine kinase (>2.0 times upper limit of the reference range) (u/L) were noted.|12 Months|Safety analysis set: All participants who received at least one dose of study medication were included.||Participants|||Number
737303|NCT00448916|Secondary|Number of Participants With Abnormalities in Endocrine Panel (Hormones).|Based on criteria for safety values of potential clinical concern, the participants with abnormal values were noted. Some of the criteria are: Free thyroxine (T4 free) (ng/dL): <0.8 LLN or >1.2 ULN and Thyroid-stimulating hormone (TSH) (mu/L): <0.8 LLN or >1.2 ULN.|12 Months|Safety analysis set: All participants who received at least one dose of study medication were included.||Participants|||Number
737304|NCT00448916|Secondary|Number of Participants With Abnormalities in Urinalysis (Dipstick/Microscopy).|Based on criteria for safety values of potential clinical concern, the participants with abnormal values were noted. Participants with Urine Protein (mg/dL) abnormalities (≥1) were noted based on urinalysis (dipstick). No participants with abnormalities in urinalysis (microscopy) were noted.|12 Months|Safety analysis set: All participants who received at least one dose of study medication were included.||Participants|||Number
737305|NCT00448916|Secondary|Number of Participants With Hematotolgical Abnormalities.|Based on criteria for safety values of potential clinical concern, the participants with abnormal values were noted. Some of the values are: platelets (10*3/mm*3): <0.5 LLN or >1.75 ULN; white blood cell (WBC) count (X10E9/L): <0.6 LLN or >1.5 ULN; lymphocytes-Abs (10*3/mm*3): <0.8 LLN or >1.2 ULN; total neutrophils-Abs (10*3/mm*3): <0.8 LLN or >1.2 ULN; and eosinophils-Abs: >1.2 ULN.|12 Months|Safety analysis set: All participants who received at least one dose of study medication were included.||Participants|||Number
737306|NCT00448916|Secondary|Number of Participants With Changes in Electrocardiogram (ECG) Data Post-Baseline Visits (Week 1 to 12 Months).|"Based on the criteria for safety values of potential clinical concern, the PR interval (≥200 msec; ≥25% increase from Baseline; ≥50% increase from Baseline), QRS complex (≥200 msec; ≥25% increase from Baseline), QT (≥500 msec), maximum QTcB interval (450-<480; 480-<500; ≥500 msec) and maximum QTcF interval (450-<480; 480-<500; ≥500 msec) values were calculated.
Baseline was defined as Day 1 of the parent study A0081074 (NCT00437281). Categorical data of the Post-Baseline vists are represented below."|Week 1 to 12 Months|Safety analysis set: All participants who received at least one dose of study medication were included.||Participants|||Number
737307|NCT00448916|Secondary|Height at Month 12/Early Termination.|Height was recorded in centimeters.|Month 12/Early Termination|Safety analysis set: All participants who received at least one dose of study medication were included.||cm||Standard Deviation|Mean
737308|NCT00448916|Secondary|Change From Baseline in Body Weight at Day 9, Week 1, Month 1, Month 2, Month 4, Month 6, Month 9, Month 12/Early Termination and Follow-up.|Weight was recorded in kilograms and weight change from Baseline was reported.|Baseline, Day 9, Week 1, Month 1, Month 2, Month 4, Month 6, Month 9, Month 12/Early Termination and Follow-up|Safety analysis set: All participants who received at least one dose of study medication were included.||Kg||Standard Deviation|Mean
737309|NCT00448916|Secondary|Derived Body Mass Index Data (BMI) at Month 12/Early Termination.|BMI was calculated from height and weight measured at Month 12 visit using the formula: weight(kg)/height(m)2.|Month 12/Early Termination|Safety analysis set: All participants who received at least one dose of study medication were included. Data was available for 15, 11, 10 and 7 participants in Pregabalin 1-23 months group, 2-6 years group, 7-11 years group and 12-16 years group respectively.||Kg/m^2||Standard Deviation|Mean
737310|NCT00448916|Secondary|Number of Participants With Significant Change in Supine Heart Rate (HR) at Post Baseline Visits (Visit 1 to 12 Months).|Participants with significant heart rate values with the criteria > 1.5 times ULN or < 0.9 times LLN were identified and recorded. The categorical summary of Post-Baseline supine HR data are presented below.|Visit 1 to 12 Months|Safety analysis set: All participants who received at least one dose of study medication were included.||Participants|||Number
737311|NCT00448916|Secondary|Number of Participants With Significant Change in Supine Systolic BP at Post Baseline Visits (Visit 1 to 12 Months).|Participants with significant supine systolic BP values with the criteria ≥ 30% increase from Baseline or ≥ 30% decrease from Baseline or > 1.25 times ULN or < 0.9 times LLN were identified and recorded. The categorical summary of Post-Baseline supine systolic BP data are presented below.|Visit 1 to 12 Months|Safety analysis set: All participants who received at least one dose of study medication were included.||Participants|||Number
737312|NCT00448916|Secondary|Number of Participants With Significant Change in Supine Diastolic Blood Pressure (BP) at Post-Baseline Visits (Visit 1 to 12 Months).|Participants with significant supine diastolic BP values with the criteria ≥ 20% increase from Baseline or ≥ 20% decrease from Baseline or > 1.25 times upper limit of normal (ULN) or < 0.9 times lower limit of normal (LLN) were identified and recorded. The categorical summary of Post-Baseline supine diastolic BP data are presented below.|Visit 1 to 12 Months|Safety analysis set: All participants who received at least one dose of study medication were included.||Participants|||Number
737313|NCT00448916|Secondary|Number of Participants With Change From Previous Neurological Examination Results at Visit 1, Week 1, Month 1, Month 6, Month 12/Early Termination and Follow-up.|Changes from previous examinations in neurological examination were reported. The neurologic exam were performed by a pediatric neurologist or qualified staff member. Coordination, cranial nerves, gait, level of consciousness, lower and upper extremity sensation, muscle strength, muscle tone, nystagmus, reflexes, Romberg test, and speech were examined.|Visit 1, Week 1, Month 1, Month 6, Month 12/Early Termination and Follow-up|Safety analysis set: All participants who received at least one dose of study medication were included.||Participants|||Number
737314|NCT00448916|Secondary|Number of Participants With Change From Previous Physical Examination Results at Visit 1, Week 1, Month 1, Month 6, Month 12/Early Termination and Follow-up.|"Changes from previous examinations in physical examination were reported. Examination of abdomen, breasts, ears, extremities, eyes, genitourinary, head, heart, lungs, lymph nodes, mouth, musculoskeletal, neck, nose, ocular fundi, skin, throat, thyroid and general examinations were done. Evaluation was done based on presence of abnormality which were noted as abnormal and no abnormalities in the sites were reported as normal. Any change from the previous physical examination results were noted."|Visit 1, Week 1, Month 1, Month 6, Month 12/Early Termination and Follow-up.|Safety analysis set: All participants who received at least one dose of study medication were included.||Participants|||Number
737315|NCT00448916|Primary|Number of Participants With Adverse Events (AE).|An AE is any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. A serious adverse event (SAE) is any untoward medical occurrence at any dose that: results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in congenital anomaly/birth defect.|12 Months|Safety analysis set: All participants who received at least one dose of study medication were included.||Participants|||Number
737316|NCT00449033|Secondary|EQ-5D Visual Analog Scale (VAS) Scores in the ITT (Non-squamous) Population|The EQ-5D also contains a visual analog scale (EQ-VAS), which records the respondent's self-rated health status on a vertical graduated visual analog scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).|from randomization of the first patient until 38 months later or death whatever occurs first|All patients valid for the ITT analysis who have a baseline and at least one post baseline value.||scores on a scale||95% Confidence Interval|Least Squares Mean
737317|NCT00449033|Secondary|Euro Quality of Life - 5D (EQ-5D) Index Scores in the ITT (Non-squamous) Population|The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index score which ranges from -0.594 to 1 when the United Kingdom (UK) weights are applied (0=death, 1=perfect health). Higher index scores represent better health states.|from randomization of the first patient until 38 months later or death whatever occurs first|All patients valid for the ITT analysis who have a baseline and at least one post baseline value.||scores on a scale||95% Confidence Interval|Least Squares Mean
737318|NCT00449033|Secondary|Time to Symptomatic Deterioration (TSD) in the ITT (Non-squamous) Population|TSD is defined as the time from randomization to the date of symptomatic deterioration (≥3 point decline in the LCS score that is maintained for at least 2 consecutive cycles) or death if death occurs before these 2 consecutive cycles are completed.|from randomization of the first patient to 38 months later or death whatever occurs first|All patients valid for the ITT analysis who have a baseline and at least one post baseline value.||months||95% Confidence Interval|Median
737319|NCT00449033|Secondary|Lung Cancer Subscale (LCS) Scores in the ITT (Non-squamous) Population|LCS is a subscale of FACT-L measuring lung cancer specific symptoms. The LCS scores range from 0 to 28, higher scores represent fewer lung cancer symptoms.|from randomization of the first patient to 38 months later or death whatever occurs first.|All patients valid for the ITT analysis who have a baseline and at least one post baseline value.||scores on a scale||95% Confidence Interval|Least Squares Mean
737320|NCT00449033|Secondary|Functional Assessment of Cancer Treatment-Lung (FACT-L) Scores in the ITT (Non-squamous) Population|The FACT-L measures health related quality of life (HRQOL) and composes of five domains: the four domains (physical well being, emotional well being, social well being, functional well being) from the Functional Assessment of Cancer Treatment-General scale (FACT-G) and the lung cancer subscale (LCS). The FACT-L total score ranges from 0 to 136, higher scores represent better HRQOL.|from randomization of the first patient until 38 months|All patients valid for the ITT analysis who have a baseline and at least one post baseline value.||scores on a scale||95% Confidence Interval|Least Squares Mean
737321|NCT00449033|Secondary|Time to Response (TTR) in the ITT (Non-squamous) Population|TTR for patients who achieved a best response (CR or PR) was defined as the time from date of randomization to the earliest date that response was first documented.|from randomization of the first patient until 38 months or date of death of any cause whichever came first|Evaluation of TTR based on ITT (non-squamous) population. No statistical testing performed.||days||95% Confidence Interval|Median
737322|NCT00449033|Secondary|Duration of Stable Disease (SD) in the ITT (Non-squamous) Population|Duration of SD was defined as the time from date of randomization to date that disease progression (radiological or clinical, whichever was earlier) was first documented. Patients without disease progression at the time of analysis or death before progression were censored at the date of their last tumor assessment.(Disease progression: increase in the sum of tumor lesion sizes or new lesions.) Duration of stable disease was only evaluated in patients failing to achieve a best response of CR or PR.|from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks|Evaluation of duration of stable disease based on ITT (non-squamous) population. No statistical testing performed.||days||95% Confidence Interval|Median
737323|NCT00449033|Secondary|Duration of Response in the ITT (Non-squamous) Population|Duration of response was defined as the time from date of first documented objective response of PR or CR, whichever was noted earlier, to date of disease progression or death (if death occurred before progression was documented). Patients without disease progression at the time of analysis or death before progression were censored at the last date of tumor evaluation. Disease progression: increase in the sum of tumor lesion sizes or new lesions.|from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks|Evaluation of duration of response based on ITT (non-squamous) population. No statistical testing performed.||days||95% Confidence Interval|Median
737324|NCT00449033|Secondary|Disease Control (DC) in the ITT (Non-squamous) Population|DC was defined as the total number of patients whose best response was not PD according to RECIST (version 1.0) by Investigator-assessment (= total number of CR + total number of PR + total number of SD; CR or PR had to be maintained for at least 28 days from the first demonstration of that rating, SD had to be documented at least once more than 6 weeks from baseline). PD: an increase in the sum of tumor lesions sizes or new lesions.|from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks|Evaluation of Disease Control based on ITT (non-squamous) population.||percentage of participants|||Number
737325|NCT00449033|Secondary|Percentage of Participants With Different Tumor Response in the ITT (Non-squamous) Population|Tumor response (= Best Overall Response) of a patient was defined as the best tumor response (confirmed Complete Response (CR: disappearance of tumor lesions), confirmed Partial Response (PR: a decrease of at least 30% in the sum of tumor lesion sizes), Stable Disease (SD: steady state of disease), or Progressive Disease (PD: an increase in the sum of tumor lesions sizes or new lesions)) observed during trial period assessed according to the RECIST criteria (version 1.0) based on Investigator-assessment.|from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks|Evaluation of Tumour Response based on ITT (non-squamous) population.||percentage of participants|||Number
737326|NCT00449033|Secondary|Time to Progression (TTP) in the ITT (Non-squamous) Population|TTP was defined as the time from date of randomization to disease progression (radiological or clinical, whichever was earlier, based on Investigator-assessment using RECIST version 1.0). Patients without progression at the time of analysis or death before progression were censored at their last date of tumor evaluation. Disease progression: increase in the sum of tumor lesion sizes or new lesions.|from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks|Evaluation of TTP based on ITT (non-squamous) population. TTP for patients with no tumour assessments after baseline was censored at one day.||days||95% Confidence Interval|Median
737327|NCT00449033|Secondary|Progression-free Survival (PFS) in the ITT (Non-squamous) Population|PFS was defined as the time from date of randomization to disease progression (radiological or clinical, whichever was earlier, based on Investigator-assessment using Response Evaluation Criteria in Solid Tumors (RECIST), version 1.0) or death due to any cause, whichever occured first. Patients without progression or death at the time of analysis were censored at their last date of tumor evaluation. Disease progression: increase in the sum of tumor lesion sizes or new lesions.|from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks|Evaluation of PFS based on ITT (non-squamous) population. PFS for patients with no tumour assessments after baseline was censored at one day.||days||95% Confidence Interval|Median
737328|NCT00449033|Secondary|OS in the ITT (Squamous) Population|OS was defined as the time from date of randomization to death due to any cause. Patients still alive at the time of analysis were censored at their last date of last contact.|from randomization of the first patient until 38 months or date of death of any cause whichever came first|Evaluation of OS based on ITT (squamous) population. Patients alive at the time of analysis were censored at their last date of follow-up (last visit or contact or at the data cut-off date). In the case of an incomplete date, where day was missing, day 15 (the middle of the month) was used. No statistical testing performed.||days||95% Confidence Interval|Median
737329|NCT00449033|Secondary|OS in the ITT (Both Squamous and Non-squamous) Population|OS was defined as the time from date of randomization to death due to any cause. Patients still alive at the time of analysis were censored at their last date of last contact.|from randomization of the first patient until 38 months or date of death of any cause whichever came first|Evaluation of OS based on ITT (both non-squamous and squamous) population. Patients alive at the time of analysis were censored at their last date of follow-up (last visit or contact or at the data cut-off date). In the case of an incomplete date, where day was missing, day 15 (the middle of the month) was used.||days||95% Confidence Interval|Median
737330|NCT00449033|Primary|Overall Survival (OS) in the ITT (Non-squamous) Population|Overall survival (OS) was defined as the time from date of randomization to death due to any cause. Patients still alive at the time of analysis were censored at their last date of last contact.|from randomization of the first patient until 38 months or date of death of any cause whichever came first|Evaluation of OS based on ITT (non-squamous) population. Patients alive at the time of analysis were censored at their last date of follow-up (last visit or contact or at the data cut-off date). In the case of an incomplete date, where day was missing, day 15 (the middle of the month) was used.||days||95% Confidence Interval|Median
737331|NCT00449046|Secondary|Number of Participants With Rescue Medication-Free Nights and Days|Rescue free means without the use of other medication.|Baseline and Week 24|Efficacy analyses were performed on the secondary outcome measures and Full analysis set, defined as all the subjects who entered the treatment period, excluding all those who received no dose of study medication or who had no post-baseline data.||Participants|||Number
737332|NCT00449046|Secondary|Number of Participants With Symptom-Free Nights and Days||Baseline and Week 24|Efficacy analyses were performed on the secondary outcome measures and Full analysis set, defined as all the subjects who entered the treatment period, excluding all those who received no dose of study medication or who had no post-baseline data.||Participants|||Number
737333|NCT00449046|Secondary|Change From Baseline in Circadian Variation in Peak Expiratory Flow (PEF) During Weeks 1-24|"Circadian Variation means the various changes in a day. The peak expiratory flow rate measures how fast a person can (exhale) air using a mini-Wright peak flow meter. The average PEF for a child or adolescent whose height is 43 is 147 L/min, whose height is 66 is 454 L/min."|Baseline and during Weeks 1-24|Efficacy analyses were performed on the secondary outcome measures and Full analysis set, defined as all the subjects who entered the treatment period, excluding all those who received no dose of study medication or who had no post-baseline data.||Percent Change||Standard Deviation|Mean
737334|NCT00449046|Secondary|Change From Baseline in Evening Peak Expiratory Flow (PEF) During Weeks 1-24|"The peak expiratory flow rate measures how fast a person can (exhale) air. Then compares it to normal flow rates to predict obstruction and disease. The average PEF for a child or adolescent whose height is 43 is 147 L/min, whose height is 66 is 454 L/min."|Baseline and during Weeks 1-24|Efficacy analyses were performed on the secondary outcome measures and Full analysis set, defined as all the subjects who entered the treatment period, excluding all those who received no dose of study medication or who had no post-baseline data.||L/min||Standard Deviation|Mean
737335|NCT00449046|Secondary|Change From Baseline in Percent Predicted Morning Peak Expiratory Flow (PEF) During Weeks 1-24|Percent Predicted Morning Peak Expiratory flow were the percent of patients that were predicted to have their Peak expiratory flow in the morning.|Baseline and during Weeks 1-24|Efficacy analyses were performed on the secondary outcome measures and Full analysis set, defined as all the subjects who entered the treatment period, excluding all those who received no dose of study medication or who had no post-baseline data.||Percent Change||Standard Deviation|Mean
737336|NCT00449046|Secondary|Change From Baseline in Morning Peak Expiratory Flow (PEF) During Weeks 1-24|"PEF taken daily and average used for week 1-24 value. The peak expiratory flow rate measures how fast a person can (exhale) air. Then, compares it to normal flow rates to predict obstruction and disease. The average PEF for a child or adolescent whose height is 43 is 147 L/min, whose height is 66 is 454 L/min."|Baseline and during Weeks 1-24|Efficacy analyses were performed on the secondary outcome measures and Full analysis set, defined as all the subjects who entered the treatment period, excluding all those who received no dose of study medication or who had no post-baseline data.||L/min||Standard Deviation|Mean
737337|NCT00449046|Primary|Serious Adverse Events (SAEs) - On Therapy|"Number of participants considered by the investigator to be related to study medication.
Adverse events, Clinical laboratory tests, Adrenocortical function test, Physical examinations, 12-lead ECG, Oropharyngeal examination were included. Frequency threshold of reported SAE's is 0%(100% reported)"|Baseline to Week 24|Safety analysis was performed on the primary outcome measures, adverse events and on the safety population defined as all subjects who entered the treatment period and received at least one dose of study medication.||Participants|||Number
737338|NCT00449046|Primary|Most Frequent Adverse Events - On Therapy|Adverse events, Clinical laboratory tests, Adrenocortical function test, Physical examinations, 12-lead electrocardiogram (ECG), Oropharyngeal examination were included.|Baseline to Week 24|Safety analysis was performed on the primary outcome measures, adverse events and on the safety population defined as all subjects who entered the treatment period and received at least one dose of study medication||Participants|||Number
737339|NCT00449072|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAE)|"Adverse events that developed, worsened, or became serious during the double-blind treatment period or within 7 days after the last dose of double-blind investigational product (IP) are defined as TEAEs.
A serious adverse event (SAE) was defined as any untoward medical occurrence that at any dose:
Resulted in death
Was life-threatening
Required inpatient hospitalization or prolongation of existing hospitalization
Resulted in persistent or significant disability/incapacity
Was a congenital anomaly/birth defect
Was a medically important event"|From Day 1 to 7 days following end of treatment (Day 360)|All randomized and treated participants, excluding those from GCP noncompliant sites.||participants|||Number
737340|NCT00449072|Secondary|24 Hour Cortisol/Creatinine Ratio|Urine cortisol and creatinine levels were determined at screening, at the end of treatment, and at follow-up visit using routine laboratory testing. The normal range for urinary free cortisol for 3- to 9-year-olds was considered to be [1.4 - 21 μg/24 hours]. No normal range is available for cortisol/creatinine ratio.|Baseline (2 to 6 weeks before Day 1), end of treatment (Day 360), and at follow-up (Day 420)|All randomized and treated participants, excluding those from GCP noncompliant sites.||μg/g Creatinine||Standard Deviation|Mean
737341|NCT00449072|Secondary|24 Hour Urinary Free Cortisol Levels|Urine cortisol levels was determined at screening, at the end of treatment, and at follow-up visit using routine laboratory testing. The normal range for urinary free cortisol for 3- to 9-year-olds was considered to be [1.4 - 21 μg/24 hours].|Baseline (2 to 6 weeks before Day 1), end of treatment (Day 360), and at follow-up (Day 420)|All randomized and treated participants, excluding those from GCP noncompliant sites.||μg/24 hours||Standard Deviation|Mean
737342|NCT00449072|Secondary|Percentage of Days Participants Used the Rescue Medication During the Double-blind Treatment Phase of the Study|"Children's Claritin® syrup was provided as a rescue medication to control allergic rhinitis (AR) symptoms and could be used throughout the study on an as needed basis. Use of rescue medication was to be documented in the participant's diary.
The percentage of days that participants used the rescue medication during the double-blind treatment phase of the study."|double-blind treatment period (Day 1 to Day 360)|mITT population: All randomized and treated participants with at least 3 post-randomization height measurements during the double-blind treatment period, excluding those from GCP noncompliant sites.||percentage of days||Standard Deviation|Mean
737343|NCT00449072|Secondary|Percentage of Participants Who Used the Rescue Medication During the Double-blind Phase of the Study|"Children's Claritin® syrup was provided as a rescue medication to control allergic rhinitis (AR) symptoms and could be used throughout the study on an as needed basis. Use of rescue medication was to be documented in the participant's diary.
The percentage of participants who used the rescue medication during each of the study periods is reported."|Baseline (4-6 months before Day 1), double-blind treatment period (Day 1 to Day 360) and follow-up (Day 361 to Day 420)|mITT population: All randomized and treated participants with at least 3 post-randomization height measurements during the double-blind treatment period, excluding those from GCP noncompliant sites.||percentage of participants|||Number
737344|NCT00449072|Secondary|Global Efficacy as Assessed by the Investigator During and at the End of the Double-blind Treatment Period|"Global efficacy was assessed by the investigator using the following scale:
0 = no relief (symptoms unchanged or worse than before)
1 = slight relief (symptoms were present and only minimally improved)
2 = moderate relief (symptoms were present and could have been troublesome but were noticeably improved)
3 = marked relief (symptoms were greatly improved and although present were scarcely troublesome)
4 = complete relief (virtually no symptom present)"|Day 120, Day 240 and Day 360|mITT population: All randomized and treated participants with at least 3 post-randomization height measurements during the double-blind treatment period, excluding those from GCP noncompliant sites.||score on a scale||Standard Deviation|Mean
737345|NCT00449072|Secondary|Global Efficacy as Assessed by the Participant (With the Help of a Parent/Guardian/Caregiver) During and at the End of the Double-blind Treatment Period|"Global efficacy was assessed by the participant (with the help of a parent/guardian/caregiver) using the following scale:
0 = no relief (symptoms unchanged or worse than before)
1 = slight relief (symptoms were present and only minimally improved)
2 = moderate relief (symptoms were present and could have been troublesome but were noticeably improved)
3 = marked relief (symptoms were greatly improved and although present were scarcely troublesome)
4 = complete relief (virtually no symptom present)"|Day 120, Day 240 and Day 360|mITT population: All randomized and treated participants with at least 3 post-randomization height measurements during the double-blind treatment period, excluding those from GCP noncompliant sites.||score on a scale||Standard Deviation|Mean
737346|NCT00449072|Secondary|Change From Baseline in Four Individual Nasal Symptom Scores at the End of Treatment|"PAR symptoms - nasal stuffiness, nasal discharge, sneezing, and nasal itching were scored upon arising in the morning according to the following 4-point scale:
0 = symptom absent
1 = mild (present but not annoying to self)
2 = moderate (annoying to self but not interfering with sleep or daily living)
3 = severe (interfered with daily living and/or sleep)
Individual symptom scores ranged from 0 (best outcome) to 3 (worst outcome). A negative value for change represents an improvement in symptoms."|For 7 days prior to randomization (Baseline) and everyday for 7 days prior to Day 360 (end of treatment)|mITT population with available nasal symptom scores: All randomized and treated participants with at least 3 post-randomization height measurements during the double-blind treatment period with available nasal symptom scores, excluding those from GCP noncompliant sites.||score on a scale||Standard Error|Least Squares Mean
737347|NCT00449072|Secondary|Change From Baseline in Instantaneous Total Nasal Symptom Score (TNSS)|"PAR symptoms - nasal stuffiness, nasal discharge, sneezing, and nasal itching were scored upon arising in the morning according to the following 4-point scale:
0 = symptom absent
1 = mild (present but not annoying to self)
2 = moderate (annoying to self but not interfering with sleep or daily living)
3 = severe (interfered with daily living and/or sleep)
TNSS was the sum of the individual symptom scores (ranging 0-3), and TNSS ranged from 0 (best outcome) to 12 (worst outcome). A negative value for change represents an improvement in symptoms."|For 7 days prior to randomization (Baseline) and everyday for 7 days prior to Day 360 (end of treatment)|mITT population with scores available for TNSS: All randomized and treated participants with at least 3 post-randomization height measurements during the double-blind treatment period with scores available for TNSS, excluding those from GCP noncompliant sites.||score on a scale||Standard Error|Least Squares Mean
737348|NCT00449072|Primary|Growth Velocity|"Individual participant's growth velocity over double-blind treatment period was calculated using a linear regression of height over time.
Height was measured on the same wall-mounted Harpenden stadiometer with the participant barefoot and in light clothing."|Day 1 to end of treatment (Day 360)|The modified intent-to-treat (mITT) population included all intent-to-treat participants who had at least 3 postrandomization visits with recorded height measurements during the double-blind treatment period, excluding those from Good Clinical Practice (GCP) noncompliant sites.||cm/year||Standard Error|Least Squares Mean
737349|NCT00449150|Secondary|Quality Of Life||Patient questionnaire||||||
737382|NCT00440830|Primary|Postoperative Pain Score One Hour After Surgery|Postoperative pain reported after the first hour using a standard numerical rating scale (NRS) with 0=no pain and 10=worst pain imaginable.|1 hour after surgery|||Numeric Rating Scale (NRS)||Standard Deviation|Mean
737350|NCT00449150|Primary|International Prostate Symptoms Score (IPSS)|IPSS score of BPH symptoms based on a patient questionnaire assessing 7 items (incomplete voiding, frequency, intermittency, urgency, weak stream, hesitancy, nocturia) on a scale from 0 (best) to 5 (worst); total range: 0 points (best) to 35 points (worst)|Baseline and 52 weeks|The ITT population included all participants for whom at least one post-baseline efficacy assessment was available; imputation per Last Observation Carried Forward (LOCF)||Units on a scale||Standard Deviation|Mean
737351|NCT00449163|Secondary|Rate of Toxicity in Study Participants|Evaluation the safety and toxicities of protocol regimen as evidenced by the rate of serious adverse events in study participants.|2 years|||percentage of participants|||Number
737352|NCT00449163|Secondary|Median Progression-free Survival in Months|Median number of months subjects achieved progression-free survival|2 years|||months||95% Confidence Interval|Median
737353|NCT00449163|Secondary|Response Rate (Complete Response and Partial Response)|Percentage of patients achieving complete response or partial response per RECIST criteria ver 1.0|2 years|||percentage of participants||95% Confidence Interval|Number
737354|NCT00449163|Primary|Overall Survival up to 2 Years|Percentage of patients with overall survival times of up to 2 years|2 years|||percentage of participants||95% Confidence Interval|Number
737355|NCT00449176|Secondary|Responder Analysis 50% Improvement|"Defined by the proportion of subjects achieving at least 50% improvement from baseline in the primary endpoint of change from baseline of the average pain intensity based on the 11-point Numerical Rating Scale (NRS) at week 12. The subjects were to indicate the level of pain experienced over the previous 12 hours on an 11-point NRS where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Baseline and Week 12|Intent to Treat Analysis Set||Percentage of participants|||Number
737356|NCT00449176|Secondary|Change From Baseline in EuroQol-5® (EQ-5D) Health Status Index to Week 12|"Change from baseline to end point in EuroQol-5 Dimension Questionnaire. A higher score indicates an improvement in health in the Health Status Index. The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating full health and 0 representing dead."|Baseline and 12 week endpoint|Intent to Treat Analysis Set, LOCF imputation method. The patients who didi not have any assessment during the treatment period were excluded from the analysis.||scores on a scale||Standard Deviation|Mean
737357|NCT00449176|Secondary|Number of Participants With Treatment Discontinuation Due to Lack of Efficacy|The number of participants who discontinued due to lack of efficacy from baseline to endpoint|Baseline and 12 weeks|Intent to Treat Analysis Set||participants|||Number
737358|NCT00449176|Secondary|Percentage of Patients Who Reported Very Much Improved or Much Improved From Baseline in Patient Global Impression of Change Over the Last Week of the Maintenance Period at Week 12|Ordinal measure indicating change from start of treatment (On a scale of 7 = Very much Worse to 1 = very much improved)|Baseline and 12 week endpoint|Intent to Treat Analysis (ITT) set, Last Observation Carried Forward (LOCF) imputation method. The ITT analysis set included all randomized subjects who took at least one dose of study medication following randomization. The patients who didi not have any assessment during the treatment period were excluded from the analysis.||percentage of participants|||Number
737359|NCT00449176|Secondary|Change From Baseline in Sleep Latency Time in Hours Over the Last Week of the Maintenance Period at Week 12.|"A Sleep Questionnaire addressed the following question: How long after bedtime/lights out did you fall asleep last night (hours)? 12 week endpoint-mean changes from baseline at endpoint for sleep latency. Decrease in time(hours) indicates improvement."|Baseline and 12 week endpoint|Intent to Treat population with LOCF imputation. The patients who didi not have any assessment during the treatment period were excluded from the analysis.||hours||Standard Deviation|Mean
737360|NCT00449176|Secondary|Change From Baseline in Brief Pain Inventory (BPI) Total Pain Score Over the Last Week of the Maintenance Period at Week 12.|"Total pain score where zero equals no pain to ten equals pain as bad as you can imagine from 12 week endpoint vs baseline."|Baseline and 12 week endpoint|Intent to Treat (ITT) analysis set, last observation carried forward (LOCF) imputation. The ITT analysis set included all randomized patients that took at least one dose of study medication following randomization. The patients who didi not have any assessment during the treatment period were excluded from the analysis.||scores on a scale||Standard Deviation|Mean
737361|NCT00449176|Primary|Change From Baseline of the Average Pain Intensity Based on a 11-point Numerical Rating Scale (NRS) Over the Last Week of the Maintenance Period at Week 12.|"For this twice daily pain assessment, the subjects were to indicate the level of pain experienced over the previous 12 hours on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Baseline and 12 weeks|Intent To Treat (ITT) analysis set utilizing Last Observation Carried Forward (LOCF) imputation. The ITT analysis set included all randomized patients that took at least one dose of study medication following randomization. 7 patients (3 tapentadol ER, 3 oxycodone CR, 1 placebo) had no baseline pain scores therefore excluded from the analysis.||scores on a scale||Standard Deviation|Mean
737362|NCT00440557|Secondary|Participants With an Increase of ≥1 g/dL in Hb Concentration From Baseline by Week 9|The change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. Hb increase is defined as the post-baseline Hb level minus the baseline Hb level.|From baseline to Week 9|Modified Intent-To-Treat (mITT) population. The mITT population was defined as all participants who were randomized and had at least 1 postrandomization Hb concentration measurement.||participants|||Number
737363|NCT00440557|Post-Hoc|Maximum (Max) Hb Rate (g/dL/2 Weeks) of Rise During First 22 Weeks of Treatment|Change is calculated as mean hemoglobin (Hb) over last 8 wks subtracts baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. Max Hb RR observation was identified for each participant during the 1st 22 wks of treatment. This was the max RR in hemoglobin over any 2-wk period per participant.|From baseline to Week 22|Safety population. The safety population was defined as all participants who received at least 1 injection of study drug.||g/dL/2 weeks||Standard Deviation|Mean
738781|NCT00458211|Secondary|Abnormal Involuntary Movement Scale (AIMS) Measures Tardive Dyskinesia|Scores 0 (none) to 4 (severe) choreo-athetoid and dystonic movements of seven parts of the body with a maximum score 28|8 weeks|17 Buffalo subjects and 19 Bronx subjects||score on scale||Standard Deviation|Mean
737364|NCT00440557|Other Pre-specified|Particpants Who Met or Exceeded Hb Rate of Rise >=2.0 g/dL/2 Weeks During First 22 Weeks of Treatment|Change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. Participants who met or exceeded a Hb Rate of Rise (RR) of 2.0 g/dL/2 weeks at least once were included in the numerator of the percentage calculation.|From baseline to Week 22|Safety population. The safety population was defined as all participants who received at least 1 injection of study drug.||participants|||Number
737365|NCT00440557|Other Pre-specified|Participants Who Met or Exceeded Hb Rate of Rise >=1.5 g/dL/2 Weeks During First 22 Weeks of Treatment|Change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. Participants who met or exceeded a Hb Rate of Rise (RR) of 1.5 g/dL/2 weeks at least once were included in the numerator of the percentage calculation.|From baseline to Week 22|Safety population. The safety population was defined as all participants who received at least 1 injection of study drug.||participants|||Number
737366|NCT00440557|Other Pre-specified|Participants Who Met or Exceeded Hb Rate of Rise >=1.0 g/dL/2 Weeks During First 22 Weeks of Treatment|Change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. Participants who met or exceeded a Hb Rate of Rise (RR) of 1.0 g/dL/2 weeks at least once were included in the numerator of the percentage calculation.|From baseline to Week 22|Safety population. The safety population was defined as all subjects who received at least 1 injection of study drug.||participants|||Number
737367|NCT00440557|Other Pre-specified|Maximum Hb Concentration (g/dL) During First 22 Weeks of Treatment|The change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. A maximum Hb observation was identified for each participant during the first 22 weeks of treatment.|From baseline to Week 22|Safety population. The safety population was defined as all participants who received at least 1 injection of study drug.||g/dL||Standard Deviation|Mean
737368|NCT00440557|Other Pre-specified|Participants Who Exceeded a Hb Concentration of 11.9 g/dL During First 22 Weeks of Treatment|The change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. participants who exceed a Hb value of 11.9 g/dL at least once were included in the numerator of the percentage calculation.|From baseline to Week 22|Safety population. The safety population was defined as all participants who received at least 1 injection of study drug.||participants|||Number
737369|NCT00440557|Primary|Change in Hb Concentration (g/dL) From Baseline to the Average of the Last 8 Weeks of Treatment Through Week 22|The change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included in calculating the average Hb during the last 8 weeks of treatment through Week 22.|From baseline through Week 22|Modified Intent-To-Treat (mITT) population. The mITT population was defined as all participants who were randomized and had at least 1 postrandomization hemoglobin concentration measurement.||g/dL||Standard Deviation|Mean
737370|NCT00440700|Secondary|Urinary Cortisol|Stress was measured by the biomarker urinary cortisol. 24-hour urine collections were obtained from eligible participants who were not receiving steroids or other medications known to affect cortisol and who had intact renal function. 24-hour urinary cortisol results were used as an integrative measure of stress (mg/day).|Daily up to 30 days|All participants with functioning kidneys who were not receiving steroids or other medications known to affect cortisol and who had two or more 24-hour urine collections were included in the analysis.||total milligrams per day||Full Range|Median
737371|NCT00440700|Secondary|Length of Mechanical Ventilatory Support|Length of mechanical ventilatory support was defined as the number of days from initial intubation and placement on mechanical ventilation to the day of extubation or death for participants in each group.|From initial intubation date to extubation or death, whichever came first, assessed up to 30 days.|Includes all subjects enrolled regardless of length of protocol participation. Mean number of days mechanically ventilated was calculated for the subjects randomized to each group/arm.||days||Standard Error|Mean
737372|NCT00440700|Secondary|Length of ICU Stay|Length of ICU stay was measured in days from the first day participant was admitted to the unit until discharged, transferred, or died in the ICU. This was the total time that any participant was in the intensive care unit which could have been longer than the 30 study protocol .|From date of ICU admission to extubation or discharge or date of death from any cause, whichever came first assessed up to 60 days|The number of participants includes all of those patients who were enrolled into the study protocol, regardless of their length of study participation.||days||Standard Error|Mean
737373|NCT00440700|Primary|State Anxiety|"Participants reported their current level of anxiety each day enrolled in the study in response to the question how are you feeling today/ The Visual analog scale-anxiety was used to evaluate the self-report of anxiety. Scores range from 0 = not anxious at all to 100 = the most anxious ever. Higher numbers indicate greater anxiety. Daily anxiety scores from all subjects were combined and analyzed for each group resulting in an overall mean anxiety score at the end of the study protocol of 30 days."|Daily up to 30 days|Participants with 3 or more visual analog scale-anxiety ratings were included in the analysis.||units on a scale||Standard Deviation|Mean
737374|NCT00440700|Primary|Sedative Exposure|Sedative exposure was measured by: 1) the number (dose frequency) of sedative medication doses administered in a 4-hour time period each day and 2) by an aggregate dose intensity of sedative medications administered in a 4-hour time period each day based on all subjects receiving sedative medications on any individual study day yielding a sedation intensity score. A sedation intensity score was calculated for each study group each study protocol day, up to 30 days. Higher sedation intensity scores indicate more sedative exposure. If a subject did not receive any sedation, the sedative exposure score is zero for that respective day.|Daily up to 30 days|Participants with 2 or more days of study enrollment data were included in the analysis for this aim.||exposures/4-hours per day||Full Range|Median
737375|NCT00440830|Primary|Postoperative Pain Score Five Days After Surgery|Postoperative pain reported after five days using a standard numerical rating scale (NRS) with 0=no pain and 10=worst pain imaginable.|5 days|||Numeric Rating Scale (NRS)||Standard Deviation|Mean
737376|NCT00440830|Secondary|Heart Rate|Heart rate reported in Beats per minute (BPM)|1 hour after surgery||||||
737383|NCT00440947|Secondary|Mean Percent Compliance at Week 144|Percent compliance is defined as the total number of pills taken divided by the total number of pills prescribed. The total number of pills taken was calculated by subtracting any returned pills from the total number of pills that were dispensed to each participant during this period. Compliance was calculated for each medication in the regimen.|Week 144|ITT-Extension Population, Extension Phase. Participants with an unknown number of pills returned (including those whose pill bottles were not returned) were not included in this analysis.||percent compliance||Standard Deviation|Mean
737384|NCT00440947|Secondary|Mean Percent Compliance at Week 84|Percent compliance is defined as the total number of pills taken divided by the total number of pills prescribed. The total number of pills taken was calculated by subtracting any returned pills from the total number of pills that were dispensed to each participant during this period. Compliance was calculated for each medication in the regimen.|Week 84|ITT-E Population, Randomized Phase. Participants with an unknown number of pills returned (including those whose pill bottles were not returned) were not included in this analysis.||percent compliance||Standard Deviation|Mean
737385|NCT00440947|Secondary|Mean Percent Compliance at Week 36|Percent compliance is defined as the total number of pills taken divided by the total number of pills prescribed. The total number of pills taken was calculated by subtracting any returned pills from the total number of pills that were dispensed to each participant during this period. Compliance was calculated for each medication in the regimen.|Week 36|ITT-E Population, Induction Phase. Participants with an unknown number of pills returned (including those whose pill bottles were not returned) were not included in this analysis.||percent compliance||Standard Deviation|Mean
737386|NCT00440947|Secondary|Number of Confirmed Virologic Failure Participants From Week 84 Through Week 144 With Treatment-emergent Reductions in HIV Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir|A blood sample was drawn for participants failing to respond to therapy, and changes in drug susceptibility for HIV isolated from the participants for each drug used in the study were assessed. For each participant, the changes in drug susceptibility detected by phenotypic assay in virus from the sample collected at the time of failure was compared with drug susceptibility in the virus from the blood sample at baseline. PAR, participant.|Week 84 through Week 144|Participants in the ITT-Extension Population (Extension Phase) who met the confirmed virologic failure criteria with paired baseline and virologic failure phenotypic evaluations||participants|||Number
737387|NCT00440947|Secondary|Number of Confirmed Virologic Failure Participants From Randomization at Week 36 Through Week 84 With Treatment-emergent Reductions in HIV Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir|A blood sample was drawn for participants failing to respond to therapy, and changes in drug susceptibility for HIV isolated from the participants for each drug used in the study were assessed. For each participant, the changes in drug susceptibility detected by phenotypic assay in virus from the sample collected at the time of failure was compared with drug susceptibility in the virus from the blood sample at baseline. PAR, participant.|Randomization at Week 36 through Week 84|Participants in the ITT-E population (Randomized Phase) who met the confirmed virologic failure (CVF) criteria with paired baseline and virologic failure phenotypic evaluations. One participant met CVF criteria at Week 36 and was randomized; these results are included in both the Week 36 and the Randomization through Week 84 results.||participants|||Number
737388|NCT00440947|Secondary|Number of Confirmed Virologic Failure Participants From Baseline Through Week 36 With Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir|A blood sample was drawn for participants failing to respond to therapy, and changes in drug susceptibility for HIV isolated from the participants for each drug used in the study were assessed. For each participant, the changes in drug susceptibility detected by phenotypic assay in virus from the sample collected at the time of failure was compared with drug susceptibility in the virus from the blood sample at baseline. PAR, participant.|Baseline through Week 36|Participants in the ITT-E Population (Induction Phase) who met the confirmed virologic failure (CVF) criteria with paired baseline and virologic failure phenotypic evaluations. One participant met CVF criteria at Week 36 and was randomized; these results are included in both the Week 36 and the Randomization through Week 84 results.||participants|||Number
737389|NCT00440947|Secondary|Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Week 84 Through Week 144|A blood sample was drawn for participants failing to respond to therapy, and the mutations present in the virus were identified. For each participant, the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New International AIDs Society-USA defined resistance mutations that developed at the time of failure were tabulated by drug class. VF, virologic failure; NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor.|Week 84 through Week 144|Participants in the ITT-Extension Population (Extension Phase) who met the confirmed virologic failure criteria with paired baseline and virologic failure genotypic evaluations.||participants|||Number
737390|NCT00440947|Secondary|Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Randomization at Week 36 Through Week 84|A blood sample was drawn for participants failing to respond to therapy, and the mutations present in the virus were identified. For each participant, the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New International AIDs Society-USA defined resistance mutations that developed at the time of failure were tabulated by drug class. VF, virologic failure; NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor.|Randomization at Week 36 through Week 84|Participants in the ITT-E Population (Randomized Phase) who met the confirmed virologic failure (CVF) criteria with paired baseline and virologic failure genotypic evaluations. One participant met CVF criteria at Week 36 and was randomized; these results are included in both the Week 36 and the Randomization through Week 84 results.||participants|||Number
737412|NCT00441012|Primary|The Anti-HBs GMT (Geometric Mean Titer) 1 Month After the Third Dose.|Geometric Mean Titer (GMT) – This is an Antibody titer that is measured using a laboratory test to detect the presence and amount of antibodies in a person's blood. Anti-HBs (Antibodies against hepatitis B surface antigen) and Geometric Mean Titers were measured from blood samples taken at Month 11 (1 month after the third dose).|11 months (1 month after the third dose)|Per-Protocol Population: The Per-Protocol Population is defined as the participants that were able to complete the study as defined by the protocol.||mIU/mL||95% Confidence Interval|Geometric Mean
737391|NCT00440947|Secondary|Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 36|A blood sample was drawn for participants failing to respond to therapy, and the mutations present in the virus were identified. For each participant, the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New resistance-associated mutations (defined by the International AIDS Society-USA guidelines) that developed at the time of failure were tabulated by drug class. PAR, participants; VF, virologic failure; NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor.|Baseline through Week 36|Participants in the ITT-E Population (Induction Phase) who met the confirmed virologic failure (CVF) criteria with paired baseline and virologic failure genotypic evaluations. One participant met CVF criteria at Week 36 and was randomized; these results are included in both the Week 36 and the Randomization through Week 84 results.||participants|||Number
737392|NCT00440947|Secondary|Change From Baseline in CD4+ Cell Count at Week 144|A CD4+ cell is a T lymphocyte that carries the CD4 antigen. Immunologic response was assessed by CD4+ counts. Change from baseline was calculated as the Week 144 value minus the baseline value. Blood was drawn to analyze for CD4+ cell count.|Baseline and Week 144|ITT-Extension Population, Extension Phase. Observed Population. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 144 visit and had a cell count obtained during that visit period.||cells/millimeters cubed (mm^3)||Standard Deviation|Mean
737393|NCT00440947|Secondary|Change From Baseline in CD4+ Cell Count at Week 84|A CD4+ cell is a T lymphocyte that carries the CD4 antigen. Immunologic response was assessed by CD4+ counts. Change from baseline was calculated as the Week 84 value minus the baseline value. Blood was drawn to analyze for CD4+ cell count.|Baseline and Week 84|ITT-E Population, Randomized Phase. Observed Population. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 84 visit and had a cell count obtained during that visit period.||cells/millimeters cubed (mm^3)||Standard Deviation|Mean
737394|NCT00440947|Secondary|Change From Baseline in CD4+ Cell Count at Week 36|Blood was drawn to analyze for CD4+ cell count. A CD4+ cell is a T lymphocyte that carries the CD4 antigen. Immunologic response was assessed by CD4+ counts. Change from baseline was calculated as the Week 36 value minus the baseline value.|Baseline and Week 36|ITT-E Population, Induction Phase. Observed Population. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 36 visit and had a cell count obtained during that visit period.||cells/millimeters cubed (mm^3)||Standard Deviation|Mean
737395|NCT00440947|Secondary|Change From Baseline in HIV-1 RNA at Week 144|Change from baseline was calculated as the Week 144 value minus the baseline value. Blood was drawn to analyze for plasma HIV viral load.|Baseline and Week 144|ITT-Extension Population, Extension Phase. Observed Population. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 144 visit and had a viral load result obtained during that visit period.||log10 c/ml||Standard Deviation|Mean
737396|NCT00440947|Secondary|Change From Baseline in HIV-1 RNA at Week 84|Change from baseline was calculated as the Week 84 value minus the baseline value. Blood was drawn to analyze for plasma HIV viral load.|Baseline and Week 84|ITT-E Population, Randomized Phase. Observed Population. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 84 visit and had a viral load result obtained during that visit period.||log10 c/ml||Standard Deviation|Mean
737397|NCT00440947|Secondary|Change From Baseline in HIV-1 RNA at Week 36|Change from baseline was calculated as the Week 36 value minus the baseline value. Blood was drawn to analyze for plasma HIV viral load.|Baseline and Week 36|ITT-E Population, Induction Phase. Observed Population. Participants could only be included in the analysis if they had completed a Week 36 visit and had a viral load result obtained during that visit period.||log10 c/ml||Standard Deviation|Mean
737398|NCT00440947|Secondary|Number of Participants Who Met the PDVF Criteria at Week 144|The number of participants enrolled in the extension phase that failed to respond to therapy from Week 84 through Week 144, based on the protocol definition of virologic failure (PDVF) was tabulated,. PDVF was defined as (a) failure to achieve plasma HIV-1 RNA <400 c/ml by Week 30 or (b) confirmed HIV-1 RNA rebound >=400 c/ml after achieving HIV-1 <400 c/ml.|Week 144|ITT-Extension Population, Extension Phase. TLOVR.||participants|||Number
737399|NCT00440947|Secondary|Number of Participants Who Met the PDVF Criteria at Week 84|The number of participants that failed to respond to therapy from the time of treatment randomization through Week 84, based on the protocol definition of virologic failure (PDVF), was tabulated. PDVF was defined as (a) failure to achieve plasma HIV-1 RNA <400 c/ml by Week 30 or (b) confirmed HIV-1 RNA rebound >=400 c/ml after achieving HIV-1 <400 c/ml.|Week 84|ITT-Exposed Population, Randomized Phase. TLOVR. One participant met PDVF criteria at Week 36 and was included in the Week 36 PDVF but had been randomized; this participant is therefore also included in this PDVF tabulation.||participants|||Number
737400|NCT00440947|Secondary|Number of Participants Who Met the Protocol-defined Virologic Failure (PDVF) Criteria at Week 36|The number of participants that failed to respond to therapy through 36 weeks on treatment, based on the protocol definition of virologic failure (PDVF), was tabulated. PDVF was defined as (a) failure to achieve plasma HIV-1 RNA <400 c/ml by Week 30 or (b) confirmed HIV-1 RNA rebound >=400 c/ml after achieving HIV-1 <400 c/ml.|Week 36|ITT-E Population, Induction Phase||participants|||Number
737401|NCT00440947|Secondary|Percentage of Participants Who Achieved HIV-1 RNA <400 c/ml at the Week 144 Visit|Percentage of PAR with HIV-1 RNA <400 c/ml at Week 144 was tabulated; stratified by baseline HIV-1 RNA (<100,000 and >=100,000 c/ml). Per TLOVR algorithm, responders were PAR with confirmed (CF) HIV-RNA <400 c/ml who had not met any non-responder (NR) criterion. NR were PAR who never achieved CF HIV RNA <400 c/ml, prematurely discontinued (DC) study or study medication (Med), had CF rebound to >=400 c/ml, or had an unconfirmed HIV RNA >=400 c/ml at last visit. Observed analysis (Obs): all observed data. M/D=F analysis: PAR with missing data/data collected after study Med DC were failures.|Week 144|ITT-Extension Population, Extension Phase||percentage of participants|||Number
737578|NCT00453349|Secondary|Number of Subjects Who Received Alternative Medicine|As alternative medicine any systemic antibacterial medication was considered.|Up to 42 days after end of treatment|The number of subjects who received alternative medicine in the PP population was analyzed. The clinical response was graded as alternative medicine (clinical cure, improvement, continued clinical cure) versus no alternative medicine.||participants|||Number
737402|NCT00440947|Secondary|Percentage of Participants Who Achieved HIV-1 RNA <400 c/ml at the Week 84 Visit|Percentage of PAR with HIV-1 RNA <400 c/ml at Week 84 was tabulated; stratified by baseline HIV-1 RNA (<100,000 and >=100,000 c/ml). Per TLOVR algorithm, responders were PAR with confirmed (CF) HIV-RNA <400 c/ml who had not met any non-responder (NR) criterion. NR were PAR who never achieved CF HIV RNA <400 c/ml, prematurely discontinued (DC) study or study medication (Med), had CF rebound to >=400 c/ml, or had an unconfirmed HIV RNA >=400 c/ml at last visit. Observed analysis (Obs): all observed data. M/D=F analysis: PAR with missing data/data collected after study Med DC were failures.|Week 84|ITT-E Population, Randomized Phase||percentage of participants|||Number
737403|NCT00440947|Secondary|Percentage of Participants Who Achieved Plasma HIV-1 RNA <400 c/ml at the Week 36 Visit|The percentage of PAR with HIV-1 RNA virus <400 c/ml from a Week 36 blood sample was tabulated. Per TLOVR algorithm, responders were PAR with confirmed (CF) HIV RNA <400 c/ml who had not met any non-responder criterion. Non-responders were PAR who never achieved CF HIV RNA <400 c/ml, prematurely discontinued (DC) study or study medication (Med; any reason), had CF rebound to >=400 c/ml, or had an unconfirmed HIV RNA >=400 c/ml at last visit. ITT-E observed analysis (Obs): all observed data. ITT-E M/D=F analysis: PAR with missing data/data collected after study Med DC were failures.|Week 36|ITT-E Population, Induction Phase||percentage of participants|||Number
737404|NCT00440947|Secondary|Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 144 Visit|Percentage of PAR with HIV-1 RNA <50 c/ml at Week 144 was tabulated; stratified by baseline HIV-1 RNA (<100,000 and >=100,000 c/ml). Per TLOVR algorithm, responders were PAR with confirmed (CF) HIV RNA <50 c/ml who had not met any non-responder (NR) criterion. NR were PAR who never achieved CF HIV RNA <50 c/ml, prematurely discontinued (DC) study or study medication (Med), had CF rebound to >=50 c/ml, or had an unconfirmed HIV RNA >=50 c/ml at last visit. Observed analysis (Obs): all observed data. M/D=F analysis: PAR with missing data/data collected after study Med DC were failures.|Week 144|ITT-Extension Population, Extension Phase: all participants exposed to at least one dose of study medication during the Extension Phase of the study||percentage of participants|||Number
737405|NCT00440947|Secondary|Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 84 Visit|A blood sample was drawn to determine the amount of HIV-1 RNA virus in c/ml at Week 84. The percentage of participants with HIV-1 RNA <50 c/ml at Week 84 was tabulated. The secondary analysis methods were: Observed (Obs; uses all visits with data in the analysis period), and missing/discontinuation=failure (M/D=F) analyses. M/D=F: participants with missing data or data collected after study medication DC were considered failures.|Week 84|ITT-E Population, Randomized Phase. The secondary analysis methods were Observed (Obs) and missing/discontinuation=failure (M/D=F) analyses.||percentage of participants|||Number
737406|NCT00440947|Secondary|Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 36 Visit|The percentage of PAR with HIV-1 RNA virus <50 c/ml from a Week 36 blood sample was tabulated. Per TLOVR algorithm, responders were PAR with confirmed viral load <50 c/ml who had not met any non-responder criterion. Non-responders were PAR who never achieved confirmed HIV RNA <50 c/ml, prematurely discontinued (DC) study or study medication (any reason), had confirmed rebound to >=50 c/ml, or had an unconfirmed HIV RNA >=50 c/ml at last visit. ITT-E observed analysis (Obs): all observed data. ITT-E M/D=F analysis: PAR with missing data/data collected after study medication DC were failures.|Week 36|ITT-E Population, Induction Phase: all participants exposed to at least one dose of study medication during the Induction Phase of the study||percentage of participants|||Number
737407|NCT00440947|Secondary|Mean Age at Baseline of Participants Randomized to Treatment for the 48-Week Randomized Phase|The mean age of participants randomized to treatment in the Randomized Phase was calculated at Baseline.|Baseline of Randomized Phase|ITT-E Population: all participants exposed to at least one dose of study medication during the Randomized Simplification Phase||years||Standard Deviation|Mean
737408|NCT00440947|Primary|Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 Copies (c) /Milliliter (ml) at the Week 84 Visit|The percentage of PAR with HIV-1 RNA virus <50 c/ml determined from a blood sample drawn at Week 84 was tabulated by treatment arm with stratification by baseline HIV-1 RNA (<100,000 c/ml and >=100,000 c/ml). Per TLOVR algorithm, responders were PAR with confirmed viral load <50 c/ml who had not met any non-responder criterion. Non-responders were PAR who never achieved confirmed HIV RNA <50 c/ml, prematurely discontinued study or study medication for any reason, had confirmed rebound to at least 50 c/ml, or had an unconfirmed HIV RNA of at least 50 c/ml at last visit.|Week 84|Intent-to-Treat (ITT)-Exposed Population, Randomized Phase: all PAR exposed to at least one dose of study medication during the Randomized Phase of the study. The primary analysis method was time to loss of virologic response (TLOVR) for the proportion of PAR with HIV-1 RNA <50 c/ml at Week 84 in the Simplification arm and Continuation arms||percentage of participants|||Number
737409|NCT00441012|Secondary|The Anti-PRP GMT (Geometric Mean Titer) 1 Month After the Third Dose.|Geometric Mean Titer (GMT) – This is an Antibody titer that is measured using a laboratory test to detect the presence and amount of antibodies in a person's blood. Anti-PRP (Antibodies against polyribosylribitol phosphate) titers were measured from blood samples taken at Month 11 (1 month after the third dose)|11 months (1 month after the third dose)|Per-Protocol Population: The Per-Protocol Population is defined as the participants that were able to complete the study as defined by the protocol.||µg /mL||95% Confidence Interval|Geometric Mean
737410|NCT00441012|Secondary|The Number of Anti-PRP Seroprotected Participants 1 Month After the Third Dose.|"The number of participants as measured by the seroprotection rate (anti-polyribosylribitol phosphate antibodies greater than 1 µg/mL). Anti-PRP (Antibodies against polyribosylribitol phosphate) titers were measured from blood samples taken at Month 11 (1 month after
the third dose)"|11 months (1 month after the third dose)|Per-Protocol Population: The Per-Protocol Population is defined as the participants that were able to complete the study as defined by the protocol.||Participants|||Number
737411|NCT00441012|Secondary|The Total Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences|Participants with adverse experiences considered possibly, probably, or definitely related to study vaccines and considered serious (death, persistent disability, life threatening, hospitalization, birth defects, cancer, or overdose)|0-11 months (recorded from first dose until the participant completes or discontinues)|Safety Analysis Set: The Safety Analysis Set is defined as all participants who receive at least one injection of vaccine and who had a safety follow-up.||Participants|||Number
738782|NCT00458211|Secondary|Cholesterol||8 weeks|See PANSS above||mg/dL||Standard Deviation|Mean
738783|NCT00458211|Secondary|Fasting Glucose||8 weeks|See PANNS above||mg/dl||Standard Deviation|Mean
737413|NCT00441012|Primary|The Number of Anti-HBs Seroprotected Participants 1 Month After the Third Dose.|The number of participants as measured by the seroprotection rate (anti-hepatitis B surface antibodies greater than or equal to 10 mIU/mL). Anti-HBs (Antibodies against hepatitis B surface antigen) titers were measured from blood samples taken at Month 11 (1 month after the third dose)|11 months (1 month after the third dose)|Per-Protocol Population: The Per-Protocol Population is defined as the participants that were able to complete the study as defined by the protocol.||Participants|||Number
737414|NCT00441064|Secondary|Percentage of Responders Defined as MASBP <130 mm Hg or a Decrease From Baseline in MASBP of ≥20 mm Hg in Systolic Hypertensive Patients Treated With Aliskiren (300 mg) for 4 Weeks on a High Sodium Diet Versus 4 Weeks on a Low Sodium Diet|To evaluate the percentage of responders defined as MASBP < 130 mm Hg or a decrease in MASBP from baseline of ≥20 mm Hg in systolic hypertensive patients treated with aliskiren (300 mg) for 4 weeks on a high sodium diet versus 4 weeks on a low sodium diet. [At week 4 patients crossed over from low to high sodium diet and vice versa for 4 weeks. Percent response for patients on high sodium diet versus low sodium diet was also analyzed at week 8 (4 weeks after crossover).]|Week 4 and Week 8 (4 weeks after crossover)|Completers Population: Included all patients who completed both diet periods - high and low sodium diets||Percentage of responders|||Number
737415|NCT00441064|Secondary|Mean 24 Hour Ambulatory Diastolic Blood Pressure (MADBP) in Systolic Hypertensive Patients Treated With Aliskiren (300 mg) for 4 Weeks on a High Sodium Diet Versus 4 Weeks on a Low Sodium Diet|To evaluate the mean 24 hour ambulatory diastolic blood pressure (MADBP) in systolic hypertensive patients treated with aliskiren (300 mg) for 4 weeks on a high sodium diet versus 4 weeks on a low sodium diet. [At week 4 patients crossed over from low to high sodium diet and vice versa for 4 weeks. MADBP for patients on high sodium diet versus low sodium diet was also analyzed at week 8 (4 weeks after crossover).]|Week 4 and week 8 (4 weeks after crossover)|Completers Population: Included all patients who completed both diet periods - high and low sodium diets||mm Hg||Standard Deviation|Mean
737416|NCT00441064|Primary|Mean 24 Hour Ambulatory Systolic Blood Pressure (MASBP) in Systolic Hypertensive Patients Treated With Aliskiren (300 mg) for 4 Weeks on a High Sodium Diet Versus 4 Weeks on a Low Sodium Diet|The primary objective of the study was to assess mean 24 hour ambulatory systolic blood pressure (MASBP) in systolic hypertensive patients treated with aliskiren (300 mg) for 4 weeks on a high sodium diet versus 4 weeks on a low sodium diet. [At week 4 patients crossed over from low to high sodium diet and vice versa for 4 weeks. MASBP for patients on high sodium diet versus low sodium diet was also analyzed at week 8 (4 weeks after crossover).]|Week 4 and week 8 (4 weeks after crossover)|Completers Population: Included all patients who completed both diet periods - high and low sodium diets||mm Hg||Standard Deviation|Mean
737417|NCT00441103|Secondary|Number of CU Active MRI Lesions|CU active lesions were defined as a unique newly active or persistently active lesion on the PD/T2 scan or the gadolinium enhanced T1 scan (with a method to avoid double counting).|Up to Week 40|ITT population included all randomized participants who received at least one dose of study drug.||lesions||Standard Deviation|Mean
737418|NCT00441103|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. AEs were categorized based upon the treatment period during which they occurred, that is, double-blind period (up to Week 16) and rater-blind period (Week 17 up to Week 40).|Baseline up to Week 40|Safety population included all randomized participants who received at least one dose of study drug. Here, 'n' signifies those participants who were evaluable for the specified category.||participants|||Number
737419|NCT00441103|Secondary|Mean Number of CU Lesions Per Scan Between the Initial 16 Weeks of Placebo Treatment and 24 Weeks of RNF Treatment in the Same Participants, Originally Randomized to Placebo.|"CU active lesions were defined as a unique newly active or persistently active lesion on the PD/T2 scan or the gadolinium enhanced T1 scan (with a method to avoid double counting). Only Placebo Followed by RNF arm was evaluable for this outcome measure."|Day 1 up to Week 16 and Week 17 up to Week 40|"ITT population included all randomized participants who received at least one dose of study drug. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure."||lesions||Standard Deviation|Mean
737420|NCT00441103|Primary|Number of Combined Unique (CU) Active Magnetic Resonance Imaging (MRI) Lesions at Week 16|CU active lesions were defined as a unique newly active or persistently active lesion on the protocol density/time constant 2 (PD/T2) scan or the gadolinium (Gd-) enhanced time constant 1 (T1) scan (with a method to avoid double counting).|16 Weeks|ITT population included all randomized participants who received at least one dose of study drug.||lesions||Standard Deviation|Mean
737421|NCT00441116|Secondary|Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation|"In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? For example, No Problem shift to No Problem indicates that the participant experienced no problem at baseline and no problem at Month 6, respectively."|Baseline to Month 10|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.||Participants|||Number
737422|NCT00441116|Secondary|Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection|"In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? For example, No Problem shift to No Problem indicates that the participant experienced no problem at baseline and no problem at Month 6, respectively."|Baseline to Month 10|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.||Participants|||Number
737423|NCT00441116|Secondary|Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive|"In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? For example, No Problem shift to No Problem indicates that the participant experienced no problem at baseline and no problem at Month 6, respectively."|Baseline to Month 10|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.||Participants|||Number
737424|NCT00441116|Secondary|Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation|"In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? For example, No Problem shift to No Problem indicates that the participant experienced no problem at baseline and no problem at Month 6, respectively."|Baseline to Month 6|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.||Participants|||Number
737425|NCT00441116|Secondary|Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection|"In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? For example, No Problem shift to No Problem indicates that the participant experienced no problem at baseline and no problem at Month 6, respectively."|Baseline to Month 6|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.||Participants|||Number
737426|NCT00441116|Secondary|Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive|"In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? For example, No Problem shift to No Problem indicates that the participant experienced no problem at baseline and no problem at Month 6, respectively."|Baseline to Month 6|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.||Participants|||Number
737427|NCT00441116|Secondary|Sexual Function Inventory - Month 10 - Sex Drive, Erection, and Ejaculation|In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem?|Month 10|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.||Participants|||Number
737428|NCT00441116|Secondary|Sexual Function Inventory - Month 6 - Sex Drive, Erection, and Ejaculation|In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem?|Month 6|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.||Participants|||Number
737429|NCT00441116|Secondary|Sexual Function Inventory - Month 3 - Sex Drive, Erection, and Ejaculation|In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem?|Month 3|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.||Participants|||Number
737430|NCT00441116|Secondary|Sexual Function Inventory - Baseline - Sex Drive, Erection, and Ejaculation|In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem?|Baseline|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.||Participants|||Number
737431|NCT00441116|Secondary|Sexual Function Inventory - Screening - Sex Drive, Erection, and Ejaculation|In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem?|Screening|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.||Participants|||Number
737432|NCT00441116|Secondary|Laboratory Values: Other Chemistry Assessed at Baseline and 6 Months.|Glucose, Creatinine, Ferritine (ug/L) and Zinc (Hmol/L)|Baseline and Month 6|Intent to Treat(ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.||mg/dL||Standard Deviation|Mean
737433|NCT00441116|Secondary|Laboratory Values: Liver Enzymes Assessed at Baseline and 6 Months.|sGOT (AST)- serum Glutamic-Oxaloacetic Transaminase, sGPT (ALT) - serum Glutamic-Pyruvic Transaminase, Alkaline Phosphatase, Bilirubin(mg/dL) and Albumin(g/dL)|Baseline and Month 6|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.||IU/L||Standard Deviation|Mean
737434|NCT00441116|Secondary|Laboratory Values: Hematology Assessed at Baseline and 6 Months.|Comparing Lab values and differences from Baseline to month 6|Baseline and Month 6|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.||thousands/microliter||Standard Deviation|Mean
737435|NCT00441116|Secondary|Laboratory Values: Electrolytes Assessed at Baseline and 6 Months.|Sodium, Potassium (mEq/L), and Bicarbonate|Baseline and Month 6|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.||mmol/L||Standard Deviation|Mean
737436|NCT00441116|Secondary|Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10.|Normal ranges: TSH, 0.25-3.50 µIU/mL; T4, 4.5-12.0 mg/dL; PSA, ≤4 ng/mL; DHT, males (m): prepuberty, <0.1, adult, 0.25-0.75; females (f): prepuberty, <0.03, premenopausal, 0.05-0.3, menopausal, <0.03 ng/mL; T, m: 2.36-9.96; f: 0.08-0.86 ng/mL; LH, m: 1-8; f: follicular, 4-12; periovulatory, >20; luteal 5-20; postmenopausal, >10 IU/L.|Baseline to Month 6 and Month 10|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint. LH was only assessed at baseline.||Participants|||Number
737437|NCT00441116|Secondary|The Percentage Change From Baseline in Testosterone at Month 3, 6, and 10|Mean percent change from Baseline for testosterone. Testosterone was measured in ng/ml.|Month 3, Month 6, and Month 10|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint.||Percent change||Standard Deviation|Mean
737438|NCT00441116|Secondary|The Percentage Change From Baseline in Dihydrotestosterone (DHT) at Month 3, 6, and 10|Mean percent change from Baseline for DHT. DHT was measured in pg/ml. Change from baseline = Month 3, 6, and 10 values minus baseline value.|Month 3, Month 6 and Month 10|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint.||Percent change||Standard Deviation|Mean
737439|NCT00441116|Secondary|Panel Assessment of Improvement Distribution From Screening|"Improvement Distribution is based on the number of hairs per centimeters squared by macrophotographic conversion hair count.
Score Range -3=greatly decreased to +3=greatly increased. 0=No change."|Baseline to Month 3 and Baseline to Month 6|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint.||Participants|||Number
737440|NCT00441116|Secondary|Investigator's Photographic Assessment of Improvements From Baseline Score|Improvement Distribution Score is based on the number of hairs per centimeters squared by macrophotographic conversion hair count. Score Range: -3 = greatly decreased to +3 = greatly increased. 0 = No change.|Month 3 and Month 6|Per Protocol Population (PP) defined as subjects in the ITT population taking study medication for 6 month and no identified as a major protocol violator.||units on a scale||Standard Deviation|Mean
737441|NCT00441116|Secondary|Investigator's Photographic Assessment of Improvement Distribution From Baseline|Improvement Distribution is based on the number of hairs per centimeters squared by macrophotographic conversion hair count. Score Range -3=greatly decreased to +3=greatly increased. 0=No change.|Month 3 and Month 6|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint.||Participants|||Number
737442|NCT00441116|Secondary|Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Appearance (Thickness, Hair Quality, Amount) of the Thinning Area on my Head is?|GlaxoSmithKline - Hair Growth Index with Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions comparing photographs of their hair before treatment and concerning the last week and evaluated the change in Hair Growth.|Month 3 and Month 6|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint.||Participants|||Number
737443|NCT00441116|Secondary|Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Amount of Hair on my Thinning Area Has?|GlaxoSmithKline - Hair Growth Index with Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions comparing photographs of their hair before treatment and concerning the last week and evaluated the change in Hair Growth.|Month 3 and Month 6|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint.||Participants|||Number
737444|NCT00441116|Secondary|Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Hair Now Covers?|GlaxoSmithKline - Hair Growth Index with Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions comparing photographs of their hair before treatment and concerning the last week and evaluated the change in Hair Growth.|Month 3 and Month 6|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint.||Participants|||Number
737445|NCT00441116|Secondary|Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment, When I Look at my Thinning Area, I Can See?|GlaxoSmithKline - Hair Growth Index with Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions comparing photographs of their hair before treatment and concerning the last week and evaluated the change in Hair Growth.|Month 3 and Month 6|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint.||Participants|||Number
737446|NCT00441116|Secondary|Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Kept What Hair I Had?|GlaxoSmithKline - Hair Growth Index without Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions without photographs concerning their perception of Change in Hair Growth.|Month 3 and Month 6|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint.||Participants|||Number
737447|NCT00441116|Secondary|Subjects Global Assessment of Hair Regrowth Question: Since Start of Treatment the Overall Appearance (Thickness, Hair Quality, Amount) of the Hair on my Head is?|GlaxoSmithKline - Hair Growth Index without Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions without photographs concerning their perception of Change in Hair Growth.|Month 3 and Month 6|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint.||Participants|||Number
737448|NCT00441116|Secondary|Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Usual Hair Loss Has Slowed Down?|GlaxoSmithKline - Hair Growth Index without Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions without photographs concerning their perception of Change in Hair Growth.|Month 3 and Month 6|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.||Participants|||Number
737449|NCT00441116|Secondary|Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Lost?|GlaxoSmithKline - Hair Growth Index without Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions without photographs concerning their perception of Change in Hair Growth.|Month 3 and Month 6|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.||Participants|||Number
737450|NCT00441116|Secondary|Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 3 Months.|The Macrophotographic hair count method marks a 1-inch diameter circular area at the anterior leading edge of the vertex thinning area and then photographed. The photographs are enlarged and converted into dot maps and the dot maps are converted into total hair counts by means of personal computer-based scanners and imaging software.|Baseline and Month 3|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.||hair count per centimeters squared||Standard Deviation|Mean
737686|NCT00454194|Secondary|Overall Survival|Overall survival was defined as the time from study enrollment (randomization) to the time of death from any cause or last follow-up.|Time from randomization to death or last follow-up (up to 5 years)|All participants who met the eligibility criteria and started the treatment.||months||95% Confidence Interval|Median
737451|NCT00441116|Primary|Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 6 Months.|The Macrophotographic hair count method marks a 1-inch diameter circular area at the anterior leading edge of the vertex thinning area and then photographed. The photographs are enlarged and converted into dot maps and the dot maps are converted into total hair counts by means of personal computer-based scanners and imaging software.|Baseline and 6 months|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.||hair count per centimeters squared||Standard Deviation|Mean
737452|NCT00441142|Secondary|PHASE I: To Define the Safety of ZD6474 (Vandetanib) With Radiation Therapy and Concomitant and Adjuvant Temozolomide in This Population.||2 years||||||
737453|NCT00441142|Secondary|PHASE II: To Further Evaluate the Safety Profile of ZD6474 (Vandetanib) in Combination With Radiation Therapy and Temozolomide in This Patient Population.||3 years||||||
737454|NCT00441142|Secondary|Median Progression-free Survival (PFS), as Calculated by the # of Months Patients Remain Progression-free|A secondary outcome of Phase II of this trial is the median progression-free survival (PFS), as calculated by the # of months patients remain progression-free|3 years|||months||95% Confidence Interval|Median
737455|NCT00441142|Primary|Median Overall Survival (OS) of Phase II Patients|The primary outcome of Phase II of this trial was to determine the efficacy of ZD6474 (Vandetanib) in combination with radiation therapy and concomitant and adjuvant temozolomide in patients with newly-diagnosed GBM and gliosarcomas as measured by overall survival and median survival.|3 years|This measure was only assessed in Participants in Phase II part of the study, who had available data for analysis||months||95% Confidence Interval|Median
737456|NCT00441142|Primary|Number of Participants That Experienced a Dose-limiting Toxicity (DLT)|The primary outcome of Phase I of this trial was to determine the maximum tolerated dose (MTD) of ZD6474 (Vandetanib) in patients with newly-diagnosed glioblastomas multiforme (GBM) and gliosarcomas who are also receiving radiation therapy with concomitant and adjuvant temozolomide. The MTD is the dose level at which 0/6 or 1/6 patients experience a dose-limiting toxicity (DLT) with the next higher dose having at least 2/3 or 2/6 patients encountering DLT.|2 years|This measure was only assessed in Participants enrolled into the Phase I part of the study who had available data for analysis.||Participants|||Number
737457|NCT00441168|Secondary|Duration of Response (DOR)|DOR was defined as the duration from the date of the best confirmed response for subjects who achieved CR or PR to the date of first documented evidence of PD (or relapse for subjects who experienced CR) over the duration of the study. DOR = ([Date of PD or date of censoring – Date of best response]+1)/30.44.|every 28 days during treatment period for up to 6 to 8 cycles|Subjects in the ITT population (all subjects who received at least one dose of study drug and who had at least one post baseline efficacy parameter) were included.There was insufficient data to perform Kaplan Meier analysis (data available for 5 subjects in the VAD group and 6 subjects in the PAD group).||months|||Number
737458|NCT00441168|Primary|Best Reported Disease Response|The primary efficacy analysis was based on the best response obtained during the treatment period according to the EBMT criteria as assessed by the investigator. The ordering of the responses was: CR, PR, MR, NC and PD. CR was the best response and the poorest response was PD.|every 28 days during treatment period for up to 6 to 8 cycles|Subjects in the ITT population (all subjects who received at least one dose of study drug and who had at least one post baseline efficacy parameter) were included.||participants|||Number
737459|NCT00441168|Primary|Best Confirmed Disease Response|The primary efficacy analysis was based on the best response obtained during the treatment period according to the European Group for Blood and Marrow Transplantation (EBMT) criteria as assessed by the investigator. The best confirmed response was defined as 2 separate and consecutive evaluations of response, at least 6 weeks apart (for progressive disease [PD], 1 to 3 weeks apart). The ordering of the responses was: complete response (CR), partial response (PR), minimal response (MR), no change (NC) and PD. CR was the best response and the poorest response was PD.|every 28 days during treatment period for up to 6 to 8 cycles|Subjects in the ITT population (all subjects who received at least one dose of study drug and who had at least one post baseline efficacy parameter) were included.||participants|||Number
737460|NCT00441259|Secondary|Geometric Mean Titers (GMTs) Using Neutralizing Antibody to Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine|Antibodies to Japanese encephalitis (JE) virus were measured with 50% plaque reduction neutralization tests (PRNT50) using JE CV virus, JE virus Nakayama strain, and JE virus strain 826309 (Indian wild-type).|Day 42 Post-vaccination|Geometric Mean Titers were assessed in participants who received all doses of the investigational product in the Treatment Period, had Baseline and post-vaccination blood samples (Day 42) for antibody analysis, per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
737461|NCT00441259|Secondary|Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine|Antibodies to Japanese encephalitis (JE) virus were measured with 50% plaque reduction neutralization tests (PRNT50) using JE CV virus, JE virus Nakayama strain, and JE virus strain 826309 (Indian wild-type). Seroconversion was defined as a titer ≥10 1/dil for participants who were seronegative at baseline and ≥ 4 fold rise for participants who were seropositive at baseline (titer ≥ 10 1/dil).|Day 42 Post Dose 1|Seroprotection was assessed in participants who received all doses of the investigational product in the Treatment Period, had Baseline and post-vaccination blood samples (Day 42) for antibody analysis, per-protocol population.||Participants|||Number
737462|NCT00441259|Primary|Geometric Mean Titers (GMTs) of Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine|Antibodies to Japanese encephalitis (JE) virus were measured with 50% plaque reduction neutralization tests (PRNT50) using JE CV virus, JE virus Nakayama strain, and JE virus strain 826309 (Indian wild-type).|Day 42 Post Dose 1|Geometric Mean Titers were assessed in participants who received all doses of the investigational product in the Treatment Period, had Baseline and post-vaccination blood samples (Day 42) for antibody analysis, per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
737716|NCT00454207|Secondary|Change in the Diastolic Pulmonary Arterial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change：Diastolic pulmonary arterial pressure at Week 12 minus diastolic pulmonary arterial pressure at baseline.|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.||mmHg||Standard Deviation|Mean
737463|NCT00441259|Primary|Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine|Antibodies to Japanese encephalitis (JE) virus were measured with 50% plaque reduction neutralization tests (PRNT50) using JE CV virus, JE virus Nakayama strain, and JE virus strain 826309 (Indian wild-type). Seroconversion was defined as a titer ≥10 1/dil for participants who were seronegative at baseline and ≥ 4 fold rise for participants who were seropositive at baseline (titer ≥ 10 1/dil).|Day 42 Post-vaccination|Seroconversion was assessed all participants who received all doses of the investigational product in the Treatment Period, had Baseline and post-vaccination samples (Day 42) for antibody analysis, per-protocol population.||Participants|||Number
737464|NCT00441259|Primary|Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine||Day 14 up to Day 42 Post-vaccination|Adverse events were assessed all enrolled and vaccinated participants, intent-to-treat (safety) population.||Participants|||Number
737465|NCT00441259|Primary|Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine||Day 14 up to Day 42 Post-vaccination|Adverse events were assessed in all enrolled participants, intent-to-treat (safety) population.||Participants|||Number
737466|NCT00441272|Secondary|Insulin Resistance||48 weeks||||||
737467|NCT00441272|Primary|Hepatic Steatosis|Evaluation of the safety and potential benefits of pioglitazone therapy on hepatic steatosis in HIV-infected men and women.|96 weeks|A total of 11 subjects enrolled into the study. 10 were determined to be ineligible during the screening as the Computerized tomography scan revealed a liver-to-spleen ratio > 1 and one was determined ineligible due to concomitant medication use.||Hounsfeld units||Standard Deviation|Mean
737468|NCT00441285|Secondary|Phase III Trial - Seizure Frequency|Seizure frequency by treatment group|Day 1 - 540|Final population numbers for this analysis not yet defined|||||
737469|NCT00441285|Primary|Phase III Trial - Proportion of Patients Without Remaining Live Cysts|Proportion of patients whose 6 month MR does not show viable parasites anymore|Day 180|Some patients did not reach the analysis time point.||participants|||Number
737470|NCT00441285|Secondary|Phase III Trial - Proportion of Cysts Which Resolved|Proportion of Viable Brain Parasites which Are not Alive Anymore at 6 Months MRI|Day 180|Final population numbers for this analysis not yet defined|||||
737471|NCT00441285|Secondary|PK Substudy - Safety of Combined Albendazole Plus Praziquantel Therapy|- Describe if some Serious Adverse Event was associated to combined Albendazole plus Praziquantel therapy.|90 days post tx|||Events|||Number
737472|NCT00441285|Primary|PK Substudy - Maximum Concentration of Albendazole|Highest serum level of Albendazole measured from all level assessments in the curve.|Treatment day 1 and Treatment days 10-11|||ng/mL||Standard Deviation|Mean
737473|NCT00441285|Secondary|PK Substudy - Area Under the Curve of Praziquantel by Antiepileptic Drug in Treatment Days 10 and 11|- To evaluate the kinetic disposition of Praziquantel by antiepileptic drug after the last praziquantel dose, we calculated the Area Under the Curve of Praziquantel with Carbamazepine or Phenytoin|0.5, 1, 1.5, 2, 3, 4, 8, 10, 12, 24 and 36 hours post dose on treatment days 10-11|||ng*h/ml||95% Confidence Interval|Mean
737474|NCT00441285|Secondary|PK Substudy - Area Under the Curve of Praziquantel by Antiepileptic Drug in Treatment Day 1|- To evaluate the kinetic disposition of Praziquantel by antiepileptic drug after the last praziquantel dose, we calculated the Area Under the Curve of Praziquantel with Carbamazepine or Phenytoin|0, 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 12 hours post dose in treatment day 1|Carbamazepine and Phenytoin were not assigned by the study.||ng*h / mL||Standard Deviation|Mean
737475|NCT00441285|Primary|PK Substudy - Area Under the Curve of Albendazole in Treatment Days 10 and 11|- To evaluate kinetic disposition of Albendazole we calculated the Area under the curve of the active metabolite of Albendazole (Albendazole Sulphoxide) with Praziquantel or Placebo (of Praziquantel).|0.5, 1, 1.5, 2, 3, 4, 8, 10, 12, 24 and 36 hours post dose on Treatment days 10-11|||ng*h/ml||95% Confidence Interval|Mean
737476|NCT00441285|Primary|PK Substudy - Area Under the Curve of Albendazole in Treatment in Day 1|- To evaluate kinetic disposition of Albendazole we calculated the Area under the curve of the active metabolite of Albendazole (Albendazole Sulphoxide) with Praziquantel or Placebo (of Praziquantel).|0, 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 12 hours post dose on Treatment day 1|||ng*h/mL||95% Confidence Interval|Mean
737477|NCT00441337|Secondary|Mean Systolic Blood Pressure at Baseline and Post-Infusion Day 1 (Cycle 1) in in 1mg, 3mg, and 10 mg Cohorts - Safety Population|Systolic blood pressures (SBPs) measured in millimeters of mercury (mmHg) were obtained while the participant was seated. Baseline, Infusion (0 minutes) and Post infusion SBPs are presented in the 1 mg, 3 mg and 10 mg cohorts at: 15, 30, 45, 60, 75, and 90 minutes post infusion and at 1, 2, 3, 4, 6, 8 hours post infusion. Baseline was defined as the last measurement before the first dose of study drug, which was calculated from pre-dose or from screening if pre-dose was not available. Mean SBPs on Day 1 for first dose (cycle 1) are presented below.|Baseline, Day 1|All participants who received at least 1 dose or any partial dose of nivolumab and had available blood pressure at baseline and post-infusion were analyzed.||mmHg||Standard Deviation|Mean
737478|NCT00441337|Secondary|Mean Diastolic Blood Pressure at Baseline and Post-Infusion Day 1 (Cycle 1) in 1mg, 3mg, and 10 mg Cohorts - Safety Population|Diastolic blood pressures (DBPs) measured in millimeters of mercury (mmHg) were obtained while the participant was seated. Baseline, Infusion (0 minutes) and Post infusion DBPs are presented in the 1 mg, 3 mg and 10 mg cohorts at: 15, 30, 45, 60, 75, and 90 minutes post infusion and at 1, 2, 3, 4, 6, 8 hours post infusion. Baseline was defined as the last measurement before the first dose of study drug, which was calculated from pre-dose or from screening if pre-dose was not available. Mean DBP on Day 1 for first dose (cycle 1) are presented below.|Baseline, Day 1|All participants who received at least 1 dose or any partial dose of nivolumab and had available blood pressure at baseline and post-infusion were analyzed.||mmHg||Standard Deviation|Mean
737532|NCT00452790|Other Pre-specified|Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 1 (6 Weeks of Age)|Systemic events (any fever >=38 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after the dose 1 of the infant series (6 weeks of age)|Safety population: all participants who received at least dose 1 of the infant series vaccination (after 6 weeks. n=number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.||Percentage of participants|||Number
737479|NCT00441337|Secondary|Mean Systolic Blood Pressure at Baseline and Post-Infusion Day 1 (Cycle 1) in 0.3 mg Cohort - Safety Population|Systolic blood pressures (SBPs) measured in millimeters of mercury (mmHg) were obtained while the participant was seated. Baseline, Infusion (0 minutes) and Post infusion SBPs are presented in the 0.3 mg cohort at: 21, 36, 51, 66, 82, 97, 112, 127, 157 minutes post infusion, and at 1, 2, 3, 4, 6, 8 hours post infusion. Baseline was defined as the last measurement before the first dose of study drug, which was calculated from pre-dose or from screening if pre-dose was not available. Mean SBP on Day 1 for first dose (cycle 1) are presented below.|Baseline, Day 1|All participants who received at least 1 dose or any partial dose of nivolumab and had available blood pressure at baseline and post-infusion were analyzed.||mmHg||Standard Deviation|Mean
737480|NCT00441337|Secondary|Mean Diastolic Blood Pressure at Baseline and Post-Infusion Day 1 (Cycle 1) in 0.3 mg Cohort - Safety Population|Diastolic blood pressures (DBPs) measured in millimeters of mercury (mmHg) were obtained while the participant was seated. Post infusion DBPs are presented in the 0.3 mg cohort at: 21, 36, 51, 66, 82, 97, 112, 127, 157 minutes post infusion, and at 1, 2, 3, 4, 6, 8 hours post infusion. Baseline was defined as the last measurement before the first dose of study drug, which was calculated from pre-dose or from screening if pre-dose was not available. Mean DBP on Day 1 for first dose (cycle 1) are presented below.|Baseline, Day 1|All participants who received at least 1 dose or any partial dose of nivolumab and had available blood pressure at baseline and post-infusion were analyzed.||mmHg||Standard Deviation|Mean
737481|NCT00441337|Secondary|Mean Change From Baseline in Electrocardiogram Parameters PR, QRS and QT in Safety Population|12-lead ECGs were performed at screening, baseline, Day 2 and at completion of the dose cycle (Day 85 in first dose cycle). In those participants undergoing re-treatment, ECG was repeated at the completion of the re-treatment. Baseline was defined as the last measurement before the first dose of study drug, which was calculated from pre-dose or from screening if pre-dose was not available. PR, QRS and QT interval were measured in milliseconds (msec).|Baseline, Day 2, Day 85, Day 113|All participants who received at least 1 dose or any partial dose of nivolumab and had available ECG at baseline and on the specified post treatment study day were analyzed.||msec||Standard Deviation|Mean
737482|NCT00441337|Secondary|Mean Change From Baseline in PSA Relative Velocity at Days 29, 57, and 85 With Cycle 1 in PSA Evaluable Population|PSA relative velocity (PSA RV) was defined as = (d[PSA]/dt)/ [PSA], where [PSA] =concentration of PSA, and t= time, and in the limit reflects the instantaneous change in PSA levels as a fraction of total PSA level. Decreases in PSA RV may occur while measured [PSA] is still rising, and may indicate that continued therapy may lead to a treatment benefit, particularly in the setting of immunotherapy, where expansion of an effective immune response is likely to require weeks to mature. Baseline PSA RV was based on the velocity of last PSA measurement before the first infusion of study drug and the screening PSA measurement.|Day 29, Day 57, Day 85|The PSA evaluable population includes all participants in the study who received complete dose(s) of nivolumab and has a baseline PSA assessment and at least 1 post-baseline PSA assessment.||percentage of total PSA level||Full Range|Median
737483|NCT00441337|Secondary|Median Time to PSA Progression in Days and Median PSA Progression Free Survival in Days in PSA Evaluable Population|Time to PSA progression: first dose to first PSA progression. Missing date of progression was censored: if death during the study, time to progression was right-censored at last PSA assessment; if no progression from first dose and still alive at end of study, time to progression was right-censored at last PSA assessment by end of study; if no PSA progression and one has discontinued from the study (other than death or PSA progression), time to progression was right-censored at last PSA assessment. PSA progression free survival (PFS): first dose to first PSA progression or death, whichever comes first. Missing date of progression was censored: if one did not have PSA progression from first dose and was still alive at end of study, PSA PFS was right-censored at last PSA assessment; if one does not have any progression and discontinued from the study for reasons other than death or progression, PFS was right-censored at last assessment. CI computed using Brookmeyer and Crowley method.|Day 1 to 2 Years|The PSA evaluable population include all participants in the study who received complete dose(s) of nivolumab and had a baseline PSA assessment and at least 1 post-baseline PSA assessment.||days||95% Confidence Interval|Median
737484|NCT00441337|Secondary|Time to Tumor Progression and Tumor Progression Free Survival|Time to tumor progression (TTP) was measured in days from date of the first dose to the date of the first PD or the date of death if due to PD. For those who died without PD it was censored at the date of death. TTP was censored at the last tumor assessment by the end of study if a participant did not have PD or death. Tumor progression free survival (PFS) was measured in days from the date of first dose to the date of the first disease progression or to the date of death. PFS was censored at the last tumor assessment date by the end of study if a participant did not have PD or death.|Day 1 to 2 Years|All participants who received at least 1 dose or any partial dose of nivolumab were analyzed.||days||95% Confidence Interval|Median
737485|NCT00441337|Secondary|Median Time to Tumor Response and Duration of Tumor Response|Time to tumor response: from the date of first dose to the first date of tumor response (CR or PR confirmed at least 4 weeks later); for nonresponders, it was censored at the date of the maximum tumor assessment time in the dose cohort by the end of study. Duration of tumor response was calculated from the first date of response of CR or PR to the date of the first PD or the date of death if a participant died due to disease progression (whichever occurred first). Duration of response was censored at the last tumor assessment date by the end of study if a responder did not have PD or death. Nonresponders had the duration of response as an event of 0 days.|Day 1 to 2 Years|All participants who received at least 1 dose or any partial dose of nivolumab and were tumor responders were analyze.||days||95% Confidence Interval|Median
737504|NCT00449644|Secondary|The Percentage of Participants With Sputum Culture Conversion (Stage 2)|The table below shows the percentage of participants in Stage 2 who were responders to treatment. Sputum culture conversion is defined as as having 2 consecutive negative cultures at least 25 days apart, not followed by a confirmed positive during the considered time period. Participants who discontinue or die during the considered time period are considered as non-responders.|Week 24, Week 72, and Week 120 (Stage 2)|The modified intent-to-treat (mITT) population used for all efficacy analyses included all randomized participants who received at least 1 dose of study drug and did not have extensively drug resistant tuberculosis (XDR-TB) or non-multi-drug resistant tuberculosis (non-MDR-TB) at the start of the trial and were evaluable for efficacy.||Percentage of Participants|||Number
738784|NCT00458211|Secondary|Weight||8 weeks|Same as PANNS above||pounds||Standard Deviation|Mean
737486|NCT00441337|Secondary|Percentage of Participants With Disease Control and Major Durable Disease Control|Disease control rate was defined as number of participants whose Best Overall Response (BOR) was complete response (CR), partial response (PR), or stable disease (SD) divided by the total number of participants. Major durable disease control rate was defined as the total number of participants whose BOR was CR, PR, or SD ≥24 weeks, divided by the total number of participants. Per RECIST v 1.0, BOR for tumors was confirmed CR or PR. CR=disappearance of all target and non-target lesions; PR=at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter since treatment; SD=neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for PD. PD=at least a 20% increase in the sum of the longest diameter recorded since screening, or the appearance of one or more new lesions. 95% CIs were computed using the Clopper and Pearson method.|Day 1 to 2 Years|Safety Population was analyzed: All participants who received at least 1 dose or any partial dose of nivolumab.||percentage of participants||95% Confidence Interval|Number
737487|NCT00441337|Secondary|Number of Participants With Best Overall Response (BOR) by Category in Safety Population|Measurable and non-measurable disease/target lesions were evaluated according to National Cancer Institute standardized RECIST.Complete Response (CR)=disappearance of all target and non-target lesions and no new lesions; Partial Response=at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter; Stable disease (SD)=neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum longest diameter since treatment; PD=at least a 20% increase in the sum of the longest diameter recorded since screening, or the appearance of one or more new lesions. BOR was recorded between the first tumor assessment and last tumor assessment. CR and PR had to be confirmed by repeat assessment no less than 4 weeks after the criteria were first met. SD assessment must have met the criteria at least once at or after Week 12.|Day 1 to Day 85|Safety Population: All participants who received at least 1 dose or any partial dose of nivolumab were analyzed.||participants|||Number
737488|NCT00441337|Primary|Percent of Participants With Prostate-Specific Antigen (PSA) Response After the First Dose by Day 85 In Participants With Hormone-Refractory Prostate Adenocarcinoma (HRPC)|The PSA response rate was defined as the number of participants who had at least a 50% decrease of the PSA value from the PSA reference value divided by the total number of participants evaluated (percent of participants). PSA reference value was the PSA concentration measured immediately prior to dosing on Day 1. PSA response was assessed using the Recommendations from the National Cancer Institute Prostate-Specific Antigen Working Group. A PSA response had to be confirmed at least 4 weeks after first response. 95% exact CIs were computed using the Clopper and Pearson method.|Day 1 to Day 85|The PSA evaluable population was analyzed and included all HRPC participants who received complete dose(s) of nivolumab and had a baseline PSA assessment and at least one post baseline PSA assessment. A PSA evaluable participant could not have any major inclusion/exclusion violation, dosing violation, or protocol conduct violation.||percentage of participants||95% Confidence Interval|Number
737489|NCT00441337|Primary|Percent of Participants With Best Overall Response Rate in Safety Population and in Tumor Evaluable Population|The Best Overall Response Rate (BORR) was defined as the number of participants who had a confirmed complete response (CR) or partial response (PR) during the study divided by the total number of participants evaluated. Response was based on tumor assessment for both target and non-target lesions using: Clinical examination; Chest X-ray; Computed Tomography and Magnetic Resonance Imaging; Bone scan; Ultrasound. Per National Cancer Institute Response Evaluation Criteria in Solid Tumors (RECIST) v1.0, best overall response (BOR) for tumors was confirmed CR or PR. CR=disappearance of all target and non-target lesions; PR=at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter. Confidence intervals (CIs) were computed using the Clopper and Pearson method.|Day 1 up to 2 Years.|Safety Population: All participants who received at least 1 dose or any partial dose of nivolumab were analyzed. Tumor Evaluable Population: all participants who received complete dose(s) of nivolumab and had completed a major tumor assessment (a baseline and at least 1 post-baseline tumor assessment for either target and/or non-target assessments.||percentage of participants||95% Confidence Interval|Number
737490|NCT00441337|Primary|Mean Volume of Distribution (Vz) Post-Single Dose|Nivolumab in human serum was assayed during the period of known analyte stability and reported as final data for this study by PPD® (Richmond, Virginia) using a cross-validated ELISA method. For the single dose (Day 1), serum concentrations of nivolumab were assessed: prior to dosing, at 30 minutes (during dosing), immediately post-dose, and 30 minutes post-infusion end time; at 1, 2, 4, 6, 8, 24, 48, and 72 hours post-infusion end time; and on Days 8, 15, 22, 29, 43, 57, 71, and 85. The PK parameter of Vz was measured in milliliters per kilogram of body weight (mL/kg).|Day 1 to Day 85|All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles were included in the summary statistics.||mL/kg||Standard Deviation|Mean
737491|NCT00441337|Primary|Geometric Mean Total Body Clearance of Drug From Serum (CLT) Post-Single Dose|Nivolumab in human serum was assayed during the period of known analyte stability and reported as final data for this study by PPD® (Richmond, Virginia) using a cross-validated ELISA method. For the single dose (Day 1), serum concentrations of nivolumab were assessed: prior to dosing, at 30 minutes (during dosing), immediately post-dose, and 30 minutes post-infusion end time; at 1, 2, 4, 6, 8, 24, 48, and 72 hours post-infusion end time; and on Days 8, 15, 22, 29, 43, 57, 71, and 85. The PK parameter of CLT was measured in milliliters per hour per kilogram body weight (mL/h/kg).|Day 1 to Day 85|All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles were included in the summary statistics.||mL/h/kg||Geometric Coefficient of Variation|Geometric Mean
737492|NCT00441337|Primary|Mean Elimination Half-life (T-HALF) Post-Single Dose|Nivolumab in human serum was assayed during the period of known analyte stability and reported as final data for this study by PPD® (Richmond, Virginia) using a cross-validated ELISA method. For the single dose (Day 1), serum concentrations of nivolumab were assessed: prior to dosing, at 30 minutes (during dosing), immediately post-dose, and 30 minutes post-infusion end time; at 1, 2, 4, 6, 8, 24, 48, and 72 hours post-infusion end time; and on Days 8, 15, 22, 29, 43, 57, 71, and 85. The PK parameter of T-HALF was measured in days.|Day 1 to Day 85|All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles were included in the summary statistics.||days||Standard Deviation|Mean
737493|NCT00441337|Primary|Geometric Mean Area Under the Curve (AUC) From Time of Dosing to Time of Last Observation (0-T) and Extrapolated to Infinity (INF) Observed Post-Single Dose|AUC(0-T): Area under the concentration-time curve from the time of dosing to the time of the last observation. AUC(INF): Area under the curve from the time of dosing extrapolated to infinity. Nivolumab in human serum was assayed during the period of known analyte stability and reported as final data for this study by PPD® (Richmond, Virginia) using a cross-validated ELISA method. For the single dose (Day 1), serum concentrations of nivolumab were assessed: prior to dosing, at 30 minutes (during dosing), immediately post-dose, and 30 minutes post-infusion end time; at 1, 2, 4, 6, 8, 24, 48, and 72 hours post-infusion end time; and on Days 8, 15, 22, 29, 43, 57, 71, and 85. The PK parameters of AUC(0-T) and AUC (INF) were measured in micrograms*hours per milliliter (µg*h/mL).|Day 1 to Day 85|All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles were included in the summary statistics.||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
737494|NCT00441337|Primary|Median Time at Which the Maximum Serum Concentration Occurred (Tmax) Post-Single Dose|Nivolumab in human serum was assayed during the period of known analyte stability and reported as final data for this study by PPD® (Richmond, Virginia) using a cross-validated ELISA method. For the single dose (Day 1), serum concentrations of nivolumab were assessed: prior to dosing, at 30 minutes (during dosing), immediately post-dose, and 30 minutes post-infusion end time; at 1, 2, 4, 6, 8, 24, 48, and 72 hours post-infusion end time; and on Days 8, 15, 22, 29, 43, 57, 71, and 85. The PK parameter of Tmax was measured in hours (h).|Day 1 to Day 85|All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles were included in the summary statistics.||h||Full Range|Median
737495|NCT00441337|Primary|Geometric Mean Maximum Serum Concentration (Cmax) Observed Post-Single Dose|Nivolumab in human serum was assayed during the period of known analyte stability and reported as final data for this study by PPD® (Richmond, Virginia) using a cross-validated enzyme-linked immunosorbent assay (ELISA) method. For the single dose (Day 1), serum concentrations of nivolumab were assessed: prior to dosing, at 30 minutes (during dosing), immediately post-dose, and 30 minutes post-infusion end time; at 1, 2, 4, 6, 8, 24, 48, and 72 hours post-infusion end time; and on Days 8, 15, 22, 29, 43, 57, 71, and 85. The pharmacokinetic (PK) parameter of Cmax was measured in micrograms per milliliter (µg/mL).|Day 1 to Day 85|All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles were included in the summary statistics.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
737496|NCT00441337|Primary|Number of Participants With Severe Adverse Events (AEs), Serious Adverse Events (SAEs), Drug-Related AEs, Deaths, Discontinuation of Study Drug Due to AE, Dose-Limiting Toxicity (DLT) AE and Immune-related AEs (irAEs) in Safety Population|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. Severe=All Grade 3 or 4 events. Death=during the study and up to 28 days past study discontinuation. AEs graded using the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0. irAEs=unknown etiology, associated with study drug and consistent with an immune phenomenon. DLT: ≥Gr 3 AE(s) or lab abnormality without alternative explanation other than drug.|Day 1 to 70 days post last dose of study drug; 28 days past study discontinuation|Safety Population: All participants who received at least 1 dose or any partial dose of nivolumab were analyzed.||participants|||Number
737497|NCT00441363|Secondary|Number of Serious Adverse Events Experienced by the Subjects||up to 24 weeks|Report of Serious adverse events that occurred in the trial.||serious adverse events|||Number
737498|NCT00441363|Secondary|Fasting Plasma Glucose and Lipids||up to 24 weeks||||||
737499|NCT00441363|Primary|Change in Baseline to End of Study in HbA1c|Too few subjects were enrolled to assess outcome to pre-specified statistical power.|up to 24 weeks|||% HbA1c||Standard Deviation|Mean
737500|NCT00449540|Secondary|Percentage of Participants Who Have Photophobia|Percentage of participants who have symptoms of photophobia two hours post treatment. For each treated aura episode, the subjects rated the severity of photophobia, nausea, and phonophobia as none, mild, moderate, or severe at baseline and recorded the presence or absence of vomiting at baseline (before application of the device) at 30 minutes, and at 1, 2, 24 and 48 hours posttreatment.|2 hours post treatment|||Percentage of participants|||Number
737501|NCT00449540|Secondary|Percentage of Participants Who Have Symptoms Phonophobia|Percentage of participants who have symptoms of phonophobia two hours post treatment. For each treated aura episode, the subjects rated the severity of photophobia, nausea, and phonophobia as none, mild, moderate, or severe at baseline and recorded the presence or absence of vomiting at baseline (before application of the device) at 30 minutes, and at 1, 2, 24 and 48 hours posttreatment.|2 hours post treatment|||Percentage of Participants|||Number
737502|NCT00449540|Secondary|Percentage of Participants Who Have Symptoms of Nausea|Percentage of participants who have symptoms of nausea two hours post treatment. For each treated aura episode, the subjects rated the severity of photophobia, nausea, and phonophobia as none, mild, moderate, or severe at baseline and recorded the presence or absence of vomiting at baseline (before application of the device) at 30 minutes, and at 1, 2, 24 and 48 hours posttreatment.|two hours post treatment|||percentage of participants|||Number
737503|NCT00449540|Primary|Percentage of Participants Experiencing no Pain at Two Hours Post-treatment|Number of participants experiencing no pain at two hours post-treatment divided by total number of participants treated. For each treated aura episode during the migraine treatment phase, the subjects rated the pain intensity of their headache as none, mild, moderate or severe at baseline (before application of the study device) at 30 minutes, and at 1, 2, 24, and 48 hours posttreatement.|Two hours|Full-analysis set: intention to treat population (201) adjusted for those participants who did not administer treatment during the study period||percentage of participants|||Number
737717|NCT00454207|Secondary|Change in the Systolic Pulmonary Arterial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change：Systolic pulmonary arterial pressure at Week 12 minus Systolic pulmonary arterial pressure at baseline.|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.||mmHg||Standard Deviation|Mean
737505|NCT00449644|Secondary|The Percentage of Participants With Sputum Culture Conversion (Stage 1)|The table below shows the percentage of participants in Stage 1 who were responders to treatment. Sputum culture conversion is defined as as having 2 consecutive negative cultures at least 25 days apart, not followed by a confirmed positive during the considered time period. Participants who discontinue or die during the considered time period are considered as non-responders.|Week 8, 24, and 104 (Stage 1)|The modified intent-to-treat (mITT) population used for all efficacy analyses included all randomized participants who received at least 1 dose of study drug and did not have extensively drug resistant tuberculosis (XDR-TB) or non-multi-drug resistant tuberculosis (non-MDR-TB) at the start of the trial and were evaluable for efficacy.||Percentage of Participants|||Number
737506|NCT00449644|Secondary|The Time to Sputum Culture Conversion at Week 72 (Stage 2)|The table below shows the time to sputum culture conversion. Sputum culture conversion is defined as as having 2 consecutive negative cultures at least 25 days apart, not followed by a confirmed positive during the considered time period. Participants who discontinue or die during the considered time period are considered as non-responders and censored at their last assessment.|Week 72, Stage 2|The modified intent-to-treat (mITT) population used for all efficacy analyses included all randomized participants who received at least 1 dose of study drug and did not have extensively drug resistant tuberculosis (XDR-TB) or non-multi-drug resistant tuberculosis (non-MDR-TB) at the start of the trial and were evaluable for efficacy.||Days||95% Confidence Interval|Median
737507|NCT00449644|Secondary|The Time to Sputum Culture Conversion at Week 24 (Stage 1)|The table below shows the time to sputum culture conversion. Sputum culture conversion is defined as as having 2 consecutive negative cultures at least 25 days apart, not followed by a confirmed positive during the considered time period. Participants who discontinue or die during the considered time period are considered as non-responders and censored at their last assessment.|Week 24, Stage 1|The modified intent-to-treat (mITT) population used for all efficacy analyses included all randomized participants who received at least 1 dose of study drug and did not have extensively drug resistant tuberculosis (XDR-TB) or non-multi-drug resistant tuberculosis (non-MDR-TB) at the start of the trial and were evaluable for efficacy.||Days||95% Confidence Interval|Median
737508|NCT00449644|Primary|The Time to Sputum Culture Conversion at Week 24 (Stage 2)|The table below shows the time to sputum culture conversion. Sputum culture conversion is defined as as having 2 consecutive negative cultures at least 25 days apart, not followed by a confirmed positive during the considered time period. Participants who discontinue or die during the considered time period are considered as non-responders and censored at their last assessment.|Week 24, Stage 2|The modified intent-to-treat (mITT) population used for all efficacy analyses included all randomized participants who received at least 1 dose of study drug and did not have extensively drug resistant tuberculosis (XDR-TB) or non-multi-drug resistant tuberculosis (non-MDR-TB) at the start of the trial and were evaluable for efficacy.||Days||95% Confidence Interval|Median
737509|NCT00449644|Primary|The Time to Sputum Culture Conversion at Week 8 (Stage 1)|The table below shows the time to sputum culture conversion. Sputum culture conversion is defined as as having 2 consecutive negative cultures at least 25 days apart, not followed by a confirmed positive during the considered time period. Participants who discontinue or die during the considered time period are considered as non-responders and censored at their last assessment.|Week 8, Stage 1|The modified intent-to-treat (mITT) population used for all efficacy analyses included all randomized participants who received at least 1 dose of study drug and did not have extensively drug resistant tuberculosis (XDR-TB) or non-multi-drug resistant tuberculosis (non-MDR-TB) at the start of the trial and were evaluable for efficacy.||Days||95% Confidence Interval|Median
737510|NCT00449696|Secondary|Acetaminophen Consumption|Weekly mean acetaminophen consumption between weeks 9 and 13.|Weeks 9 to 13 (5 weeks)|ITT population was used for analysis. 2 patients with Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.||milligrams||Standard Deviation|Mean
737511|NCT00449696|Secondary|Change From Baseline in Physician Global Evaluations|Observed physician global evaluations on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning excellent feeling in knee joint; 100 mm meaning poor feeling in knee joint. Change in score from baseline to week 13 was calculated as baseline minus week 13. Primary endpoint was the model estimated difference between Gel-200 and PBS placebo.|Baseline and Week 13|ITT population was used for analysis. 2 patients with Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule.||scores on a scale||Standard Deviation|Mean
737512|NCT00449696|Secondary|Change From Baseline in Subject Global Evaluations|Observed subject evaluations on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning excellent feeling in knee joint; 100 mm meaning poor feeling in knee joint. Change in score from baseline to week 13 was calculated as baseline minus week 13. Primary endpoint was the model estimated difference between Gel-200 and PBS placebo.|Baseline and Week 13|ITT population was used for analysis. 2 patients with Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.||scores on a scale||Standard Deviation|Mean
737513|NCT00449696|Primary|Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) Pain Subscore|Observed WOMAC pain subscore on VAS of 100 mm; 0 mm meaning no pain; 100 mm meaning extreme pain. Change in score from baseline to week 13 was calculated as baseline minus week 13. Primary endpoint was the model estimated difference between Gel-200 and PBS placebo.|Baseline and Week 13|ITT population was used for analysis. 2 patients with Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.||scores on a scale||Standard Deviation|Mean
737514|NCT00449696|Secondary|Change From Baseline in Short Form - 36 (SF-36)|Scored on physical component scale from 0 (negative health) to 100 (positive health). Calculated norm based with a mean of 50 and a standard deviation of 10.|Baseline and Week 13|ITT population was used for analysis. 2 patients with Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.||scores||Standard Deviation|Mean
737761|NCT00454649|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) for Carboplatin||0 (pre-dose), 0.25, 0.5, 1, 2, 3, 5 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3|Cmin was analyzed only for orally administered drugs.||ng/mL||Standard Deviation|Mean
737515|NCT00449696|Secondary|Outcome Measures in Rheumatology Arthritis Clinical Trials (OMERACT)- and the Osteoarthritis Research Society International (OARSI) Response|Outcome Measures in Rheumatology Clinical Trials and Osteoarthritis Research Society International (OMERACT-OARSI) strict responses defined by changes from baseline in WOMAC pain or physical function subscore ≥50% with absolute changes ≥20 mm (termed strict responders), or ≥20% with absolute changes ≥10mm in 2 of 3 measures of WOMAC pain or physical function subscore or subject global evaluations (termed responders).|Weeks 6 to 13|ITT population was used for analysis. 2 patients with Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.||Percentage|||Number
737516|NCT00449696|Secondary|Change From Baseline in WOMAC VAS Total Score|Mean of all WOMAC pain, stiffness and physical function subscores on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning no pain, stiffness and difficulty; 100 mm meaning extreme pain, stiffness and difficulty. Change in score from baseline to week 13 was calculated as baseline minus week 13. Primary endpoint was the model estimated difference between Gel-200 and PBS placebo.|Baseline and Week 13|ITT population was used for analysis. 2 patients with Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.||scores on a scale||Standard Deviation|Mean
737517|NCT00449696|Secondary|Change From Baseline in WOMAC VAS Physical Function Subscore|Observed WOMAC physical function subscore on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning no difficulty; 100 mm meaning extreme difficulty. Change in score from baseline to week 13 was calculated as baseline minus week 13. Primary endpoint was the model estimated difference between Gel-200 and PBS placebo.|Baseline and Week 13|ITT population was used for analysis. 2 patients with Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.||scores on a scale||Standard Deviation|Mean
737518|NCT00449696|Secondary|Change From Baseline in WOMAC VAS Stiffness Subscore|Observed WOMAC stiffness subscore on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning no stiffness; 100 mm meaning extreme stiffness. Change in score from baseline to week 13 was calculated as baseline minus week 13. Primary endpoint was the model estimated difference between Gel-200 and PBS placebo.|Baseline and Week 13|ITT population was used for analysis. 2 patients with Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.||scores on a scale||Standard Deviation|Mean
737519|NCT00452673|Secondary|Number of Participants On-study With Grade 3 - 4 Chemistry Laboratory Values in Those Participants With a Baseline Laboratory Value of Grade 0 - Safety Population|CTC, Version 3 used to assess parameters. (ULN)=upper limit of normal: (ALT)= alanine transaminase; (AST)=aspartate aminotransferase; (ALP)=alkaline phosphatase. ALT Grade (Gr)1:>ULN to 2.5*ULN; Gr 2: >2.5 to 5.0*ULN; Gr 3: >5.0 to 20.0*ULN; Gr 4: >20.0*ULN. AST Gr 1: >ULN to 2.5*ULN; Gr 2: >2.5 to 5.0*ULN; Gr 3: >5.0 to 20.0*ULN; Gr 4: >20.0*ULN. Total bilirubin Gr 1: >ULN to 1.5*ULN; Gr 2: >1.5 to 3.0*ULN; Gr 3: >3.0 to 10.0*ULN; Gr 4: >10.0*ULN. ALP (U/L) Gr1:>ULN to 2.5*ULN, Gr2:>2.5 to 5.0*ULN, Gr3:>5.0 to 20.0*ULN, Gr4:>20.0*ULN. Albumin (low) Gr 1:<LLN - 3 grams per deciliter (g/dL)to <LLN - 3 g/dL; Gr 2: <3 - 2 g/dL to < 3.0 - 2.0 g/dL; Gr 3: < 2 g/dL to <2 g/L. Participants with a baseline chemistry lab value of Gr 0 but who had Gr 3 - 4 chemistry value while on-study are presented below.|Day 1 to 30 days post last dose|Safety Population: All participants with at least 1 dose of study drug. N=number of participants with Grade 0 values at baseline in each dosing arm, respectively.||participants|||Number
737520|NCT00452673|Secondary|Number of Participants On-Study With Grade 3 - 4 Hematology Laboratory Test Values in Those Participants With a Baseline Laboratory Value of Grade 0 - Safety Population|National Cancer Institute Common terminology criteria (CTC), Version 3 used to assess parameters. Lower limit of normal (LLN). CTC criteria: Absolute neutrophil count (ANC). Leukocytes (White blood cells) Grade (Gr) 1:<LLN to 3.0*10^9/L, Gr 2:<3.0 to 2.0*10^9/L, Gr 3:<2.0 to 1.0*10^9/L, Gr 4:<1.0*10^9/L. ANC Gr 1:<LLN to 1.5*10^9/L, Gr 2:<1.5 to 1.0*10^9/L, Gr 3:<1.0 to 0.5*10^9/L, Gr 4:<0.5*10^9/L. Platelet count Gr 1:LLN to 75.0*10^9/L, Gr 2:<75.0 to 50.0*10^9/L, Gr 3:<50.0 to 25.0*10^9/L, Gr 4:<25.0 to 10^9/L. Hemoglobin Gr 1:<LLN to 10.0 g/dL, Gr 2:<10.0 to 8.0 g/dL, Gr 3:<8.0 to 6.5 g/dL, Gr 4:<6.5 g/dL. Participants with a baseline hematology lab value of Gr 0 but who had Gr 3 - 4 hematology value while on-study are presented below.|Day 1 up to 30 days post last dose|Safety Population: All participants with at least 1 dose of study drug. N=number of participants with Grade 0 values at baseline in each dosing arm, respectively.||participants|||Number
737521|NCT00452673|Secondary|Objective Response Rate (ORR) and Disease Control Rate - Efficacy Evaluable Population|Objective response rate was the percentage of participants, (n/N; number with objective response per Number evaluated) whose best response is either a Complete Response (CR) or a Partial Response (PR). Disease control rate was defined as percentage (n/N) of participants with stable disease greater than (>) 6 months, PR, or CR. Efficacy Evaluable Population: All participants with at least one measurable lesion at baseline, who received at least one dose of combination study drug and have at least one on-study tumor assessment or stopped study treatment prior to first assessment, were evaluated. Those who stop treatment prior to tumor assessment for reasons unrelated to disease or drug were excluded.|Day 1 up to 30 days post last dose|n=number of participants with ORR: 2, 1, 0, 6 in dosing arms 1, 2, 3, and 4, respectively. n= number of participants with Disease control: 3, 2, 2, 14 in dosing arms 1, 2, 3, and 4, respectively.||percentage of participants||95% Confidence Interval|Number
737531|NCT00452790|Other Pre-specified|Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 2 (10 Weeks of Age)|Systemic events (any fever >=38 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after the dose 2 of the infant series (10 weeks of age)|Safety population: all participants who received dose 2 of the infant series vaccination (10 weeks of age); n= number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.||Percentage of participants|||Number
737566|NCT00453193|Primary|Number of Participants With Objective Response|Objective Responses are Complete or Partial Responses: Complete Response defined as disappearance of all evidence of disease detectable by morphology of peripheral blood and bone marrow and computer tomography scanning at the end of therapy, if indicated; and Partial Response as 50% or more reduction in detectable disease, but short of complete response, maintained for 1 month or at least 50% reduction of sum of the products of the diameter of all lesions for 1 month.|After a maximum of 6 months of therapy maintained for one month.|Analysis was per protocol.||Participants|||Number
737522|NCT00452673|Secondary|Number of Participants With Overall Response to Tumor - Efficacy Evaluable Population|Complete Response (CR): disappearance of all target and non-target lesions, with confirmation at >=4 weeks interval; Partial Response (PR): >= 30% decrease in sum of longest diameter (LDs) of target lesions, taking as reference the baseline sum LD, with confirmation at >= 4 weeks interval. Progressive Disease (PD): Appearance of new lesion(s), or >=20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions. Stable disease was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, without unequivocal progression of non-target lesions, after >=6 weeks on study. Radiological tumor assessment by computed tomography (CT) or magnetic resonance imaging (MRI) occurred every 6 weeks. For those patients who were on treatment > 24 weeks, the tumor assessment occurred every 9 weeks.|Day 1 to 30 days post last dose|All participants with at least one measurable lesion at baseline, who received at least one dose of the combination therapy and have at least one on-study tumor assessment or stopped study treatment prior to first assessment, were evaluated. Those who stopped drug prior to tumor assessment for reasons unrelated to disease or drug were excluded.||participants|||Number
737523|NCT00452673|Secondary|Number of Participants With Deaths, Serious Adverse Events, Adverse Events, Adverse Events Leading to Discontinuation and Treatment-related Adverse Events - Safety Population|Adverse events (AEs) were evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Serious AE (SAE)=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.|Day 1 up to 30 days post last dose|Safety Population: all participants receiving at least one dose of study drug.||participants|||Number
737524|NCT00452673|Primary|Number of Participants With Dose Limiting Toxicities Per Dose Level - Safety Population|Safety was assessed from first dose of study drug through at least 30 days after the last dose, until resolution of drug-related toxicity or when toxicity was deemed irreversible, whichever was longer. An adverse event (AE) was considered a dose limiting toxicity (DLT) if it occurred in the first 21 days and was at least possibly related to study drugs and were: Clinically-evident toxicity of Grade >= 3, or of Grade 2 which required interruption of treatment for >= 7 days (consecutive or non-consecutive); non-hematologic abnormal laboratory value of Grade >= 3, or hematologic toxicity of Grade 4, which persisted 7 days; any grade toxicity which in the judgment of the investigator required a dose reduction or removal from further study therapy.|Day 1 to 30 days post last dose|Safety Population: All participants who received at least one dose of study drug. DLTs: Grade 3 headache, Grade 3 pneumonia, Grade 3 diarrhea in Dosing arms, 1, 2, and 3, respectively. DLTs in dose arm 4: 1 participant with Grade 3 pneumonia and pain and 1 participant with Grade 4 neutropenia and diarrhea plus Grade 3 vomiting and mucositis.||participants|||Number
737525|NCT00452699|Secondary|Rate of Asthma Attacks Per Participant Per Year|The rate of asthma attacks was defined as the mean number of attacks per participant per year. An asthma attack was defined as a 20% decrease in AM PEF, a 70% increase in albuterol use, or the occurrence of an asthma exacerbation requiring oral steroids or hospitalization.|Week 1 through Week 52|ITT Population||attacks per participant per year||95% Confidence Interval|Mean
737526|NCT00452699|Secondary|Mean Change From Baseline in the Percentage of Symptom-free Days Over Weeks 1-52|A symptom-free day was defined as a day without asthma symptoms, as measured via the daily asthma symptom score (measuring symptoms during the day and previous night) on a 6-point scale (ranging from 0 to 5). A symptom score of 0=no symptoms, 1=symptoms for one short period, 2=symptoms for two or more short periods, 3=symptoms that did not affect normal daily activities, 4=symptoms that did affect normal daily activities, 5=symptoms so severe that daily activities could not be performed. Change from baseline was calculated as the average of the Week 1-Week 52 values minus the baseline value.|Baseline and Week 1 through Week 52|Participants in the ITT Population for which at least 1 week of diary data were provided||Percentage of symptom-free days||Standard Error|Mean
737527|NCT00452699|Secondary|Mean Change From Baseline in AM PEF Over Weeks 1-52|Morning (AM) peak expiratory flow (PEF) is defined as the maximum volume of air exhaled in liters per minute. Change from baseline was calculated as the average of the Week 1 through Week 52 values minus the baseline value.|Baseline and Week 1 through Week 52|Participants in the ITT Population who had a minimum of 1 week PEF values||Liters/minute (L/min)||Standard Error|Mean
737528|NCT00452699|Primary|Mean Change From Baseline in Pre-dose FEV1 Over Weeks 1-52|Pulmonary function was measured by forced expiratory volume in one second (FEV1), which is the volume of air exhaled from the lungs in one second. Change from baseline was calculated as the average of the Week 1 through Week 52 values minus the baseline value.|Baseline and Week 1 through Week 52|Intent-to-Treat (ITT) Population: all participants randomized to study drug||Liters||Standard Error|Mean
737529|NCT00452790|Other Pre-specified|Percentage of Participants With Pre-specified Systemic Events: Toddler Dose (12 Months of Age)|Systemic events (any fever >=38 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after the toddler dose(12 months of age)|Safety population: all participants who received toddler dose vaccination (12 months of age).n= number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.||Percentage of participants|||Number
737530|NCT00452790|Other Pre-specified|Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 3 (14 Weeks of Age)|Systemic events (any fever >=38 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after the dose 3 of the infant series (14 weeks of age)|Safety population: all participants who received dose 3 of the infant series vaccination (14 weeks of age).n= number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.||Percentage of participants|||Number
737567|NCT00453206|Secondary|Treatment-related Mortality at 100 Days After Transplantation||100 days||||||
737568|NCT00453206|Secondary|Quality of Life at the Time of Transplantation||baseline||||||
737569|NCT00453206|Secondary|Iron Status at the Time of Transplantation||baseline||||||
737533|NCT00452790|Other Pre-specified|Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (12 Months of Age)|Local reactions were reported using an electronic diary by the parent/legal guardian. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration and erythema present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 4 days after the toddler dose (12 months of age)|Safety population: all participants who received toddler dose vaccination(after 12 months). n= number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.||Percentage of participants|||Number
737534|NCT00452790|Other Pre-specified|Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (14 Weeks of Age)|Local reactions were reported using an electronic diary by the parent/legal guardian. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration and erythema present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 4 days after the dose 3 of the infant series (14 weeks of age)|Safety population: all participants who received all 3 doses of the infant series vaccination (14 weeks of age).n= number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.||Percentage of participants|||Number
737535|NCT00452790|Other Pre-specified|Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (10 Weeks of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 4 days after the dose 2 of the infant series (10 weeks of age)|Safety population: all participants who received the first 2 doses of the infant series vaccination (10 weeks of age).n= number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.||Percentage of participants|||Number
737536|NCT00452790|Other Pre-specified|Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (6 Weeks of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 4 days after the dose 1 of the infant series (6 weeks of age)|Safety population: all participants who received dose 1 of the infant series vaccination (6 weeks of age). n= number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.||Percentage of participants|||Number
737537|NCT00452790|Other Pre-specified|GMC for Serotype-specific Pneumococcal IgG Antibody, 1 Month After the Toddler Dose|Antibody GMC as measured in mcg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were presented.|1 month after toddler dose (13 months of age)|Evaluable immunogenicity population: had treatments as randomized at all 4 doses, blood drawn within specified timeframes, had at least 1 valid and determinate assay result for the proposed analysis, and no major protocol violations. n=number of participants with determinate IgG antibody concentration for the specified serotype.||mcg/mL||95% Confidence Interval|Geometric Mean
737538|NCT00452790|Secondary|Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Mcg/mL, 1 Month After the Toddler Dose.|Percentage of participants achieving a predefined antibody level of greater than or equal to 0.35 mcg/mL along with the corresponding exact, 2-sided 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F and 19 A) are presented.|1 month after the toddler dose (13 months of age)|Evaluable immunogenicity population: had treatments as randomized at all 4 doses, blood drawn within specified timeframes, had at least 1 valid and determinate assay result for the proposed analysis, and no major protocol violations. n=number of participants with determinate IgG antibody concentration for the specified serotype.||Percentage of participants||95% Confidence Interval|Number
737539|NCT00452790|Primary|Percentage of Participants Achieving a Predefined Antibody Level for Concomitant Vaccine Pertussis Antigens (Pertussis Toxoid [PT], Filamentous Hemagglutinin [FHA], Pertactin [PRN]), 1 Month After the Infant Series.|Percentage of participants achieving a predefined antibody level (measured in enzyme-linked immunosorbent assay [ELISA] units per mL [EU/mL]) along with the corresponding O'Brien-Fleming-adjusted, exact, 2-sided 95% CI for concomitant antigens pertussis (PT, FHA and PRN) are presented.|1 month after the infant series (18 weeks of age)|Evaluable immunogenicity population: had treatments as randomized at all 3 doses, blood drawn within specified timeframes, had at least 1 valid and determinate assay result for the proposed analysis, and no major protocol violations.||Percentage of participants||95% Confidence Interval|Number
737540|NCT00452790|Other Pre-specified|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the 3-Dose Infant Series|Antibody GMC as measured in mcg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding O'Brien-Fleming-adjusted, 2-sided 95% CIs were calculated.|1 month after the 3-dose infant series (18 weeks of age)|Evaluable immunogenicity population: had treatments as randomized at all 3 doses, blood drawn within specified timeframes, had at least 1 valid and determinate assay result for the proposed analysis, and no major protocol violations. n=number of participants with determinate IgG antibody concentration for the specified serotype.||mcg/mL||95% Confidence Interval|Geometric Mean
737570|NCT00453206|Secondary|Graft-versus-host Disease||monthly||||||
737571|NCT00453206|Secondary|Disease-free Survival||monthly||||||
737572|NCT00453206|Secondary|Overall Survival||monthly||||||
737573|NCT00453206|Secondary|Complete Response||monthly||||||
737574|NCT00453206|Primary|Treatment-related Mortality Within the First 6 Months After Transplantation||6 months|||participants|||Number
737575|NCT00453310|Primary|Confirmed Objective Response Rate (Complete and Partial Response) as Measured by RECIST Criteria After 2 Courses of Treatment||2 years|||participants|||Number
737541|NCT00452790|Primary|Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (Mcg)/mL, 1 Month After the Infant Series.|Percentage of participants achieving a predefined antibody level of greater than or equal to 0.35 mcg/mL along with the corresponding O'Brien-Fleming-adjusted, exact, 2-sided 95% confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F and 19 A) are presented.|1 month after the infant series (18 weeks of age)|Evaluable immunogenicity population: had treatments as randomized at all 3 doses, blood drawn within specified timeframes, had at least 1 valid and determinate assay result for the proposed analysis, and no major protocol violations. n=number of participants with determinate IgG antibody concentration for the specified serotype.||Percentage of participants||95% Confidence Interval|Number
737542|NCT00452868|Primary|Neurocognitive Function as Measured by the Neurocognitive Battery at 24 Weeks|Delis-Kaplan Executive Function System Tower Total Scaled Score, range is 1-19 with the higher score being a better outcome.|24 weeks|||units on a scale||Standard Deviation|Mean
737543|NCT00453063|Secondary|Change From Baseline in AM Peak Nasal Inspiratory Flow (PNIF) Averaged Over Days 2 to 15|Participants were to measure nasal airflow twice daily (in the morning prior to study drug dosing and in the evening) using their PNIF meter. The highest of 3 assessments was to be recorded in the electronic diary. The PNIF meter limits were between 30 and 370 liters/minute. Normal values range between 100 and 150 liters/minute. A positive change from Baseline correlates with improved nasal air flow.|Baseline and 15 days|All randomized participants were to be included in the analysis (intent-to-treat principle). However, subjects with a missing evaluation at a given visit or time point were not included in the analysis for that evaluation. This included participants without a baseline score for a given change-from-baseline evaluation.||liters/minute||Standard Deviation|Least Squares Mean
737544|NCT00453063|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Total Score at Endpoint (Last Post Baseline Evaluation Carried Forward)|The RQLQ consisted of 28 items that fell into the following seven domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. Each of the items was scored from 0 = not troubled to 6 = extremely troubled, and the total of the seven domains was the primary focus of this quality of life evaluation. The best possible score on this scale is 0 and the worst possible score on this scale is 42. The Endpoint was the last post baseline evaluation carried forward and was Day 15 for the majority of the participants.|Baseline and 15 days|The RQLQ tool is only validated in participants greater than or equal to 18 years of age, so it was only administered in this age group.||units on a scale||Standard Deviation|Least Squares Mean
737545|NCT00453063|Secondary|Change From Baseline in AM NOW Nasal Congestion Score Averaged Over Days 2 to 15|Nasal congestion was one of the symptoms measured in the TNSS and was scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe. The best possible score on this scale is 0 and the worst possible score on this scale is 3.|Baseline and 15 days|All randomized participants were to be included in the analysis (intent-to-treat principle). However, subjects with a missing evaluation at a given visit or time point were not included in the analysis for that evaluation. This included participants without a baseline score for a given change-from-baseline evaluation.||units on a scale||Standard Deviation|Least Squares Mean
737546|NCT00453063|Primary|Change From Baseline in the Average AM Instantaneous (NOW) Total Ocular Symptom Score (TOSS) Averaged Over Days 2 to 15|TOSS was defined as the sum of the following three ocular symptoms: redness of eyes, itching/burning eyes, and tearing/watering eyes; each symptom scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe. The best possible score on this scale is 0 and the worst possible score on this scale is 9.|Baseline and 15 days|All randomized participants were to be included in the analysis (intent-to-treat principle). However, subjects with a missing evaluation at a given visit or time point were not included in the analysis for that evaluation. This included participants without a baseline score for a given change-from-baseline evaluation.||units on a scale||Standard Deviation|Least Squares Mean
737547|NCT00453063|Primary|Change From Baseline in the Average AM Instantaneous (NOW) Total Nasal Symptom Score (TNSS) Averaged Over Days 2 to 15|TNSS was defined as the sum of the following four nasal symptoms: rhinorrhea, nasal congestion/stuffiness, nasal itching, sneezing; each symptom scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe. The best possible score on this scale is 0 and the worst possible score on this scale is 12.|Baseline and 15 days|All randomized participants were to be included in the analysis (intent-to-treat principle). However, subjects with a missing evaluation at a given visit or time point were not included in the analysis for that evaluation. This included participants without a baseline score for a given change-from-baseline evaluation.||units on a scale||Standard Deviation|Least Squares Mean
737548|NCT00453102|Secondary|Number of Participants With Unacceptable Toxicity.|Number of participants with treatment-related (possible, probable, or definite) grade 3 or higher non-hematologic adverse events.|Up to 12 weeks post-therapy|||participants|||Number
737549|NCT00453102|Secondary|5 Year Rate of Overall Survival (5-Year OS)|Percentage of participants still alive five years after the date of protocol therapy initiation.|5 Years|||percentage of participants||90% Confidence Interval|Number
737550|NCT00453102|Secondary|Overall Survival (OS) Rate|The time from the date of initiation of study treatment until date of death from any cause for all participants.|End of Study|Median overall survival by Kaplan-Meier method for all patients was not attained.||months|||Number
737551|NCT00453102|Secondary|5-Year Rate of Progression-Free Survival (5-Year PFS)|Percentage of participants still alive without disease progression five years after the date of protocol therapy initiation.|5 Years|||percentage of participants||90% Confidence Interval|Number
737552|NCT00453102|Secondary|Rate of Progression-Free Survival|The time from the start of protocol therapy until the first documented or confirmed disease progression, or death related to study disease, whichever is earlier.|End of study.|||months||Full Range|Median
737553|NCT00453102|Primary|Overall Rate of Response (ORR) in Participants Receiving Protocol Therapy.|The overall response rate (ORR) including complete response (CR), complete response unconfirmed (CRu), and partial response (PR) in participants receiving protocol therapy.|12 weeks post-therapy|||percentage of participants||90% Confidence Interval|Number
737554|NCT00453154|Other Pre-specified|Change in Plasma Levels of PDGF|Correlated with clinical outcome (response and survival).|Baseline to within 7 days of sunitinib/placebo therapy discontinuation||||||
737555|NCT00453154|Other Pre-specified|Change in Plasma Levels of VEGF Prior to, During Single-agent, and Following Treatment With Sunitinib Malate|The frequency of tumor response by the optimally dichotomized VEGF levels will be tabulated and their association will be tested by Fisher’s exact test as well as the maximally selected rank test. The association of the VEGF levels as continuous predictor with tumor response will be tested by Wilcoxon rank sum test. Further assessments of the association of the VEGF levels as > continuous or binary variables and the tumor response will be implemented in a logistic regression while adjusting for other covariates such as performance status, weight loss and age|Baseline to within 7 days of sunitinib/placebo therapy discontinuation||||||
737556|NCT00453154|Secondary|Number of Participants With Overall Tumor Response|Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD): 20% increase in sum of longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria. Overall tumor response is the total number of CR and PRs.|Up to 3 years|Participants who were randomized to maintenance were analyzed.||participants|||Number
737557|NCT00453154|Secondary|Overall Survival|Overall survival (OS) was defined as the time from randomization to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% CI was estimated using the Kaplan Meier method.|Up to 3 years|Participants who were randomized to maintenance were analyzed.||months||95% Confidence Interval|Median
737558|NCT00453154|Primary|Progression-free Survival (Phase II)|Progression free survival (PFS) was defined as the time from maintenance randomization to progression or death of any cause. Progression free and alive patients were censored at the date of last follow-up. The median PFS with 95% CI was estimated using the Kaplan Meier method.|Up to 3 years|Participants who were randomized to maintenance were analyzed.||months||95% Confidence Interval|Median
737559|NCT00453154|Primary|Maximum Tolerated of Sunitinib Combined With Cisplatin and Etoposide (Phase I)|The maximum tolerated dose is defined at the highest sunitinib dose at which less than one third of participants develop a dose limiting toxicity (DLT). A DLT is defined as: delay of beginning cycle 2 of chemotherapy by > 7 days due to neutropenia, grade 4 hematologic toxicity lasting greater than 1 week (chemotherapy alone would be expected to cause significant grade 4 hematologic toxicity) or grade 3 or 4 nonhematologic toxicity (excluding grade 3 or 4 fatigue if the patient is found to be hypothyroid and responds to fatigue < grade 3 with thyroid replacement therapy).|21 days|Due to safety concerns, the study committee discontinued sunitinib from combination chemotherapy to study single agent sunitinib in the maintenance setting.||mg/day|||Number
737576|NCT00453336|Primary|Number of Participants Experiencing Adverse Events|Number of participants enrolled experiencing serious adverse events and/or other non-serious events|6 months|||participants|||Number
737579|NCT00453349|Secondary|Bacteriological Response at Follow-up Visit in Intent To Treat Population With Causative Organism|Subjects with at least one causative organism identified in the pre-therapy culture or a positive pre-therapy PCR result and an appropriate post-therapy bacteriological evaluation available were analyzed. Bacteriological responses at follow-up visit was analyzed exploratively in the same way as the primary efficacy variable.|28 - 42 days after completion of study drug therapy|At the follow-up visit, the bacteriological success response was classified as Eradication, and recurrence/persistence as bacteriological failures.||participants|||Number
737580|NCT00453349|Secondary|Bacteriological Response at Follow-up Visit Microbiologically Valid|Subjects with at least one causative organism identified in the pre-therapy culture or a positive pre-therapy PCR result and an appropriate post-therapy bacteriological evaluation available were analyzed. Bacteriological responses at follow-up visit was analyzed exploratively in the same way as the primary efficacy variable.|28 - 42 days after completion of study drug therapy|At the follow-up visit, the bacteriological success response was classified as eradication, and recurrence/persistence as bacteriological failures.||participants|||Number
737581|NCT00453349|Secondary|Clinical Response at Follow-up Visit on Intent To Treat Population|"All successfully treated subjects and subjects evaluated asindeterminate at TOC, who were not administered an additional antibiotic therapy would have their clinical response rate assessed at the follow-up visit. Patients with missing or indeterminate outcome were treated as non-successes."|28 - 42 days after completion of study drug therapy|At the follow-up visit, the clinical response in subjects who were non-failures at the TOC visit were graded as Continued cure, Clinical relapse or Indeterminate.||participants|||Number
737582|NCT00453349|Secondary|Clinical Response at Follow-up Visit on Per Protocol Population|Clinical response at follow up was analyzed exploratively in the same way as the primary efficacy variable. At Follow-up, the clinical response was graded as continued cure, clinical relapse, or indeterminate, of which only continued cure was considered success. Failures from end of treatment were carried forward.|28 - 42 days after completion of study drug therapy|"All successfully treated subjects and subjects evaluated as indeterminate at TOC, who were not administered an additional antibiotic therapy would have their clinical response rate assessed at the follow up visit. Patients with missing or indeterminate outcome were omitted."||participants|||Number
737583|NCT00453349|Secondary|Bacteriological Response at Test Of Cure (TOC) Visit in Intent To Treat Population With Causative Organism|Bacteriological response at the TOC was analyzed exploratively in the same way as the primary efficacy variable based on the subgroup of microbiologically valid subjects. At the TOC visit, eradication was considered a bacteriological success, and persistence, presumed persistence and superinfection were considered bacteriological failures.|7 - 14 days at TOC visit|Patients were included in this analysis if a causative organism could be established pre-therapy by culture or PCR, and if the patient was valid for intent-to-treat.||participants|||Number
737584|NCT00453349|Secondary|Bacteriological Response at Test Of Cure (TOC) Visit Microbiologically Valid|The bacteriological responses was based on the results of appropriate cultures taken before and, if necessary, during treatment, at the TOC visit and within the follow-up period. Bacteriological response at the TOC visit would also be based on repeated PCR tests for N. gonorrhoeae and C. trachomatis.|7 - 14 days at TOC visit|All subjects for whom a specific bacterial pathogen was isolated/identified from any pre-treatment culture and which was considered responsible for the infection would be assessed for bacteriological efficacy.||participants|||Number
737585|NCT00453349|Secondary|Clinical Response on Treatment for Intent To Treat Population|Clinical response during treatment was analyzed exploratively in the same way as the primary efficacy variable. At the During Therapy (Day 4 to 7) assessment, the clinical response was graded as clinical Improvement, clinical failure or indeterminate accordingly. Clinical improvement was considered success, all other outcomes as non-success.|4 - 7 days after start of therapy|Subjects who were randomized, had received at least one dose of study medication and had at least one observation after drug intake would be included in the ITT analysis. For any subject in the ITT population also valid for the PP analysis, same clinical response as in the PP analysis was applied to the ITT analysis.||participants|||Number
737586|NCT00453349|Secondary|Clinical Response on Treatment for Per Protocol Population|At the During Therapy (Day 4 to 7) assessment, the clinical response was graded as clinical Improvement (severity score reduced by >30% with improvement in temperature, clinical failure (reduction in severity score of < or equal 30% and/or no improvement in temperature) or indeterminate (clinical assessment not possible to determine).|4 - 7 days after start of therapy|Analysis was performed for the per protocol population.||participants|||Number
737587|NCT00453349|Secondary|Clinical Response 7 to 14 Days After Completion of Study Drug Therapy on Intent To Treat (ITT) Population|"For any subject in the ITT population also valid for the PP analysis, same clinical response as in the PP analysis was applied to the ITT analysis. For those subjects in the ITT population invalid for the PP analysis, any clinical response different from clinical cure was set to non-success."|7 - 14 days after completion of study drug therapy|Subjects who were randomized, had received at least one dose of study medication and had at least one observation after drug intake would be included in the ITT analysis.||participants|||Number
737588|NCT00453349|Primary|Clinical Response 7 to 14 Days After Completion of Study Drug Therapy in Per Protocol (PP) Population|Clinical cure was defined as: Reduction of the tenderness score (modified McCormack) by > 70% and apyrexia (rectal/tympanic/oral temperature value < 38.0°C or axillary temperature value < 37.5°C) and white blood cell count < 10,500/mm^3.|7 - 14 days after completion of study drug therapy|The number of subjects in the PP population was slightly higher than the planned number of subjects (184 subjects per treatment group). The most common reasons for exclusion from the population valid for efficacy in both the Moxifloxacin and Comparator were essential data missing/invalid, followed by violation of inclusion/exclusion criteria.||participants|||Number
737589|NCT00453362|Secondary|Number of Participants With Adverse Events Due to FLT-PET Imaging|The number of participants who experienced an adverse event judged by the investigator to be related to FLT-PET.|From screening to Day 112 assessment visit or study discontinuation or termination, whichever is first. On visits after Day 112, only SAE were recorded.|Patients with non−small cell lung cancer (NSCLC) who underwent FLT-PET scans.||Participants|||Number
737590|NCT00453362|Primary|Overall Survival of Patients With FLT CR/PR Versus FLT PD in Patients With CT SD at Day 56|"Overall survival (OS) was defined as the time from the date of first erlotinib dose to death.
OS was compared between patients with FLT-PET response and patients with FLT-PET progression, within the subset of patients who demonstrated SD on CT (per RECIST 1.0) at Day 56 of treatment with erlotinib.
FLT-PET response was defined as a mSUVmax from FLT-PET scans of <−25% and FLT-PET disease progression was defined as a mSUVmax from FLT-PET scans >+25% or the development of a new lesion with a mSUVmax above background not explained by another cause."|From first erlotinib treatment to death, assessed up to 2 years|"Patients who were treated with erlotinib,underwent all FLT-PET scans thru Day 56 and had SD by CT at Day 56. Censoring at last date patients known to be alive.
CT SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started."||months||Full Range|Median
737591|NCT00453362|Primary|Overall Survival of Groups by FLT Response at Day 56|"Overall survival (OS) was defined as the time from the date of first erlotinib dose to death.
OS was compared between patients with FLT-PET response and patients without FLT-PET response, independent of CT response (per RECIST 1.0) at Day 56 of treatment with erlotinib.
FLT-PET response was defined as a mSUVmax from FLT-PET scans <−25%."|From first erlotinib treatment to death, assessed up to 2 years|FLT−Evaluable Patients. Participants who were treated with erlotinib and underwent all FLT-PET scans through Day 56 were included in the analysis. Censoring occurred at the last date patients known to be alive.||months||Full Range|Median
737592|NCT00453362|Primary|Overall Survival of Patients With FDG CR/PR Versus FDG PD in Patients With CT SD at Day 56|"Overall survival (OS) was defined as the time from the date of first erlotinib dose to death.
OS was compared between patients with FDG-PET response and patients with FDG-PET progression, within the subset of patients who demonstrated stable disease (SD) on CT (per RECIST 1.0) at Day 56 of treatment with erlotinib.
FDG-PET response was defined as a mSUVmax from FDG-PET scans <−25% and FDG-PET disease progression was defined as a mSUVmax from FDG-PET scans >+25% or the development of a new lesion with a mSUVmax above background not explained by another cause."|From first erlotinib treatment to death, assessed up to 2 years|"Patients who were treated with erlotinib, underwent all FDG-PET scans thru Day 56 and had SD by CT at Day 56. Censoring at last date patients known to be alive.
CT SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since treatment start."||months||Full Range|Median
737593|NCT00453362|Secondary|FLT Response in Subgroups by CT Response at Day 56|"In patients with partial response or progressive disease on CT (per RECIST 1.0) after 56 days of erlotinib treatment, the percentage of patients who demonstrated FLT-PET responses on Day 56 defined as a mSUVmax from FLT-PET scans <−25%.
CT Partial Response defined as a 30% decrease in the sum of the longest diameter (LD) of target lesion taking as reference the baseline sum of the LD.
CT Progressive disease defined as a 20% increase in the sum of the longest diameter of target lesions taking as reference the smallest sum LD since treatment started or appearance of 1 or more new lesions."|Day 56|FLT−Evaluable Patients. Participants who were treated with erlotinib and underwent all FLT-PET scans through Day 56 were included in the analysis.||Percentage of participants||95% Confidence Interval|Number
737594|NCT00453362|Secondary|FDG Response in Subgroups by CT Response at Day 56|"In patients with partial response or progressive disease on CT (per RECIST 1.0) after 56 days of erlotinib treatment, the percentage of patients who demonstrated FDG-PET responses on Day 56 defined as a mSUVmax from FDG-PET scans <−25%.
CT Partial Response defined as a 30% decrease in the sum of the longest diameter (LD) of target lesion taking as reference the baseline sum of the LD.
CT Progressive disease defined as a 20% increase in the sum of the longest diameter of target lesions taking as reference the smallest sum LD since treatment started or appearance of 1 or more new lesions."|Day 56|FDG−Evaluable Patients. Participants who were treated with erlotinib and underwent all FDG-PET scans through Day 56 were included in the analysis.||Percentage of participants||95% Confidence Interval|Number
737595|NCT00453362|Primary|Overall Survival of Groups by FDG Response at Day 56|"Overall survival (OS) was defined as the time from the date of first erlotinib dose to death.
Overall survival (OS) was compared between patients with FDG-PET response and patients without FDG-PET response, independent of Response Evaluation Criteria in Solid Tumors (RECIST 1.0) computed tomography (CT) response at Day 56 of treatment with erlotinib. FDG-PET response was defined as a mSUVmax from FDG-PET scans <−25%."|From first erlotinib treatment to death, assessed up to 2 years|FDG-Evaluable Patients. Participants who were treated with erlotinib and underwent all FDG-PET scans through Day 56 were included in the analysis. Censoring occurred at the last date patients known to be alive.||months||Full Range|Median
737596|NCT00453362|Primary|Progression Free Survival of Patients With FLT CR/PR Versus FLT PD in Patients With CT SD at Day 56|"PFS was defined as the time from the date of first erlotinib dose to disease progression or death, whichever occurs first.
PFS was compared between patients with FLT-PET response and patients without FLT-PET response, independent of computed tomography (CT) response (per RECIST 1.0) at Day 56 of treatment with erlotinib.
FLT-PET response was defined as a mSUVmax from FLT-PET scans <−25% and FLT-PET disease progression was defined as a mSUVmax from FLT-PET scans >+25% or the development of a new lesion with a mSUVmax above background not explained by another cause."|Time from first erlotinib treatment to disease progression on CT (per RECIST 1.0) or death, whichever occurs first, assessed up to 2 years|"FLT-Evaluable patients were treated with erlotinib, underwent all FLT-PET scans through Day 56 and had SD by CT at Day 56. Censoring at last tumor assessment.
CT SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since treatment start."||weeks||Full Range|Median
737597|NCT00453362|Primary|Progression Free Survival of Groups by FLT Response at Day 56|"PFS was defined as the time from the date of first erlotinib dose to disease progression or death, whichever occurs first.
PFS was compared between patients with FLT-PET response and patients without FLT-PET response, independent of CT response (per RECIST 1.0) at Day 56 of treatment with erlotinib.
FLT-PET response was defined as a mSUVmax from FLT-PET scans <−25%."|Time from first erlotinib treatment to disease progression on CT (per RECIST 1.0) or death, whichever occurs first, assessed up to 2 years|FLT-Evaluable Patients. Participants who were treated with erlotinib and underwent all FLT-PET scans through Day 56 were included in the analysis. Censoring occurred at the date of the last tumor assessment.||weeks||Full Range|Median
737598|NCT00453362|Secondary|Percentage of Patients With FLT-PET Responses|"In patients with CT-stable disease (according to RECIST 1.0) at 56 days of erlotinib treatment, the percentage of patients who demonstrated FLT-PET responses after the initial 14 days and 56 days of erlotinib treatment.
FLT-PET response was defined as a mSUVmax from FLT-PET scans <−25%. CT SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started."|Day 14 and Day 56|FLT−Evaluable Patients. Participants who were treated with erlotinib, underwent all FLT-PET scans through Day 56 and had stable disease by CT at Day 56 were included in the analysis.||Percentage of Participants||95% Confidence Interval|Number
737599|NCT00453362|Primary|PFS of Patients With FDG-PET Complete Response (CR)/Partial Response (PR) Versus FDG-PET Progressive Disease (PD) in Patients With Computed Tomography (CT) Stable Disease (SD) at Day 56|"PFS was defined as the time from the date of first erlotinib dose to disease progression or death, whichever occurs first.
PFS was compared between patients with FDG-PET response (Complete /Partial Responses) and patients with FDG-PET progression, within the subset of patients who demonstrated stable disease on CT (per RECIST 1.0) at Day 56 of treatment with erlotinib. FDG-PET response; defined as a mSUVmax from FDG-PET scans of <−25% and FDG-PET disease progression; defined as a mSUVmax >+25% or the development of a new lesion with a mSUVmax above background not explained by another cause."|Time from first erlotinib treatment to disease progression on CT (per RECIST 1.0) or death, whichever occurs first, assessed up to 2 years|"FDG-Evaluable patients were treated with erlotinib, underwent all FDG-PET scans through Day 56 and had SD by CT at Day 56. Censoring at last tumor assessment.
CT SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since treatment start."||weeks||Full Range|Median
737600|NCT00453362|Secondary|Percentage of Patients With FDG-PET Responses|"In patients with computed tomography (CT)-stable disease (according to RECIST 1.0) at 56 days of erlotinib treatment, the percentage of patients who demonstrated FDG-PET responses after the initial 14 days and 56 days of erlotinib treatment.
FDG-PET response was defined as a mSUVmax from FDG-PET scans <−25%.
CT SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started."|Day 14 and Day 56|FDG-Evaluable patients. Participants who were treated with erlotinib, underwent all FDG-PET scans through Day 56 and had stable disease by CT at Day 56 were included in the analysis.||Percentage of Participants||95% Confidence Interval|Number
737601|NCT00453362|Primary|Progression Free Survival (PFS) of Groups by FDG Response at Day 56|"PFS was defined as the time from the date of first erlotinib dose to disease progression or death, whichever occurs first.
PFS was compared between patients with FDG-PET response and patients without FDG-PET response, independent of CT response (per RECIST 1.0) at Day 56 of treatment with erlotinib.
Mean of the percent changes in maximal standard uptake values (mSUVmax) from FDG-PET scans was used to define FDG-PET response. Based on European Organization for Research on the Treatment of Cancer (EORTC) definitions, an objective FDG-PET response was defined an mSUVmax <-25%."|Time from first erlotinib treatment to disease progression on CT (per RECIST 1.0) or death, whichever occurs first, assessed up to 2 years|FDG-Evaluable Patients. Participants who were treated with erlotinib and underwent all FDG-PET scans through Day 56 were included in the analysis. Censoring occurred at the date of the last tumor assessment.||weeks||Full Range|Median
737602|NCT00453388|Secondary|Incidence of Adverse Events|Number of subjects who developed reportable AEs, assessed using adapted version of the Common Toxicity Criteria|Up to 6 years|||Participants|||Count of Participants
737603|NCT00453388|Secondary|Incidence of Transplant-related Mortality|Number of subjects who expired due to transplant-related mortality|Up to Day 200|||Participants|||Count of Participants
737604|NCT00453388|Primary|Incidence of Grades III-IV Acute GVHD|"Number of subjects who developed maximum grade acute graft-vs-host disease
aGVHD Stages
Skin:
- a maculopapular eruption involving < 25% BSA
- a maculopapular eruption involving 25 - 50% BSA
- generalized erythroderma
- generalized erythroderma with bullous formation and often with desquamation
Liver:
- bilirubin 2.0 - 3.0 mg/100 mL
- bilirubin 3 - 5.9 mg/100 mL
- bilirubin 6 - 14.9 mg/100 mL
- bilirubin > 15 mg/100 mL
Gut:
Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall.
aGVHD Grades Grade III: Stage 2 - 4 gastrointestinal involvement and/or +2 to +4 liver involvement, with or without a rash Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death"|Up to Day 100|||Participants|||Count of Participants
737605|NCT00453388|Primary|Number of Patients Who Engraft at Each Dose of TBI Used|Number of subjects who engrafted. Engraftment defined as greater than 95% donor chimerism.|Up to Day 200|||Participants|||Count of Participants
737606|NCT00453973|Primary|Proportion of Participants With Mean Hemoglobin in the Target Range of 10.0-12.0 Grams Per Deciliter (g/dL) After Final Dosing Guideline Change||Up to 54 months|Full Analysis - Number of participants with hemoglobin assessed after dosing guideline change||percentage of participants|||Number
737607|NCT00453986|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs), for Subjects in the Flu Vaccine Cohort|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. SAEs were collected for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).|From Dose 1 (at Month 0) up to study end (at Month 6)|The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
737608|NCT00453986|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs), for Subjects in the Flu Vaccine Cohort|An unsolicited AE = any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. AEs were collected for subjects receiving Nimenrix vaccine lot A+Fluarix vaccine, Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and Mencevax ACWY vaccine (in the Flu vaccine cohort).|From Dose 1 (at Month 0) up to 1 month after vaccination (at Month 1)|The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
737609|NCT00453986|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs), in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. SAEs were collected for all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.|From Dose 1 (at Month 0) up to study end (at Month 6)|The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
737610|NCT00453986|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs), in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.|An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Unsolicited AEs were collected for all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, B and C) or the Mencevax ACWY vaccine.|From Dose 1 (at Month 0) up to 1 month after vaccination (at Month 1)|The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
737611|NCT00453986|Secondary|Number of Subjects Reporting Adverse Events (AEs) Resulting in Emergency Room (ER) Visits, for Subjects in the Flu Vaccine Cohort|AEs resulting in ER visits were collected for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).|From Dose 1 (at Month 0) up to study end (at Month 6)|The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
737612|NCT00453986|Secondary|Number of Subjects Reporting New Onset of Chronic Illness(es) (NOCIs), for Subjects in the Flu Vaccine Cohort|NOCIs assessed were autoimmune disorders, asthma, type I diabetes and allergies and were collected for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).|From Dose 1 (at Month 0) up to study end (at Month 6)|The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
737613|NCT00453986|Secondary|Number of Subjects Reporting Rash, for Subjects in the Flu Vaccine Cohort|Rash assessed were hives, idiopathic thrombocytopenic purpura and petechiae and were collected for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).|From Dose 1 (at Month 0) up to study end (at Month 6)|The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
737614|NCT00453986|Secondary|Number of Subjects Reporting Adverse Events (AEs) Resulting in Emergency Room (ER) Visits, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.|AEs resulting in ER visits were collected for all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.|From Dose 1 (at Month 0) up to study end (at Month 6)|The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
737615|NCT00453986|Secondary|Number of Subjects Reporting New Onset of Chronic Illness(es) (NOCIs), in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.|NOCIs assessed were autoimmune disorders, asthma, type I diabetes and allergies and were collected for all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.|From Dose 1 (at Month 0) up to study end (at Month 6)|The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
737616|NCT00453986|Secondary|Number of Subjects Reporting Rash, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.|Rash assessed were hives, idiopathic thrombocytopenic purpura and petechiae and were collected for all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.|From Dose 1 (at Month 0) up to study end (at Month 6)|The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
737617|NCT00453986|Secondary|Number of Subjects With Any and Severe Solicited General Symptoms, for Subjects in the Flu Vaccine Cohort|Solicited general symptoms = fatigue, gastrointestinal symptoms, headache and fever (= axillary temperature ≥ 37.5°C). Any = occurrence of any solicited general symptom irrespective of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activities. Grade 3 fever = > 39.5°C. Symptoms were collected for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).|During the 4-day (Days 0-3) follow-up period after vaccination|The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
737618|NCT00453986|Secondary|Number of Subjects With Any and Severe Solicited General Symptoms, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.|Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache and fever (= axillary temperature ≥ 37.5 degrees Celsius). Any = occurrence of any solicited general symptom irrespective of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activities. Grade 3 fever = axillary temperature > 39.5°C. Symptoms were collected for all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.|During the 4-day (Days 0-3) follow-up period after vaccination|The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
737762|NCT00454649|Secondary|Maximum Observed Plasma Concentration (Cmax) for Carboplatin||0 (pre-dose), 0.25, 0.5, 1, 2, 3, 5 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||ng/mL||Standard Deviation|Mean
737619|NCT00453986|Secondary|Number of Subjects With Any and Severe Solicited Local Symptoms, in Subjects Receiving the Fluarix Vaccine|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any solicited local symptom irrespective of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling above 50 millimeter (mm). Solicited local symptoms were collected for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine after the Fluarix vaccine administration.|During the 4-day (Days 0-3) follow-up period after Fluarix vaccine administration|The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
737620|NCT00453986|Secondary|Number of Subjects With Any and Severe Solicited Local Symptoms, for Subjects in the Flu Vaccine Cohort Receiving the Nimenrix or the Mencevax ACWY Vaccines.|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any solicited local symptom irrespective of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling above 50 millimeter (mm). Solicited local symptoms were collected for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).|During the 4-day (Days 0-3) follow-up period after meningococcal vaccination|The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
737621|NCT00453986|Secondary|Number of Subjects With Any and Severe Solicited Local Symptoms, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any solicited local symptom irrespective of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling above 50 millimeter (mm). Solicited local symptoms were collected for all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.|During the 4-day (Days 0-3) follow-up period after vaccination|The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
737622|NCT00453986|Secondary|Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations, for Subjects in the Flu Vaccine Cohort|Concentrations were expressed in geometric mean concentrations in microgram per milliliter (µg/mL) and were calculated on subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).|Prior to and one month after vaccination (at Month 0 and Month 1).|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.||µg/mL||95% Confidence Interval|Geometric Mean
737623|NCT00453986|Secondary|Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort|Assay cut-off values assessed were ≥ 0.3 microgram per milliliter (µg/mL) and ≥ 2.0 µg/mL. Blood samples were taken on subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).|Prior to and one month after vaccination (at Month 0 and Month 1).|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.||Subjects|||Number
737624|NCT00453986|Secondary|Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.|Concentrations were expressed in geometric mean concentrations in microgram per milliliter (µg/mL) and were calculated on all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.|Prior to and one month after vaccination (at Month 0 and Month 1).|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.||µg/mL||95% Confidence Interval|Geometric Mean
737625|NCT00453986|Secondary|Number of Subjects With Anti-meningococcal Polysaccharide Serogroups, A, C, W-135 and Y Antibody Concentrations Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.|Meningococcal polysaccharide serogroups, A, C, W-135 and Y = PSA, PSC, PSW-135 & PSY. Assay cut-off values assessed were ≥ 0.3 microgram per milliliter (µg/mL) and ≥ 2.0 µg/mL. Blood samples were taken on all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.|Prior to and one month after vaccination (at Month 0 and Month 1).|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.||Subjects|||Number
737626|NCT00453986|Secondary|Anti-tetanus Antibody Concentrations for Subjects in the Flu Vaccine Cohort|Concentrations were expressed in geometric mean concentrations in International unit per milliliter (IU/mL) and were calculated on subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).|Prior to and one month after vaccination (at Month 0 and Month 1).|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.||IU/mL||95% Confidence Interval|Geometric Mean
737636|NCT00453986|Secondary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups.|Assay cut-off values assessed were ≥1:8 and ≥1:128. Blood samples were taken on all subjects of both cohorts receiving 1 dose of Nimenrix vaccine lot A, B or C.|Prior to and one month after vaccination (at Month 0 and Month 1).|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.||Subjects|||Number
737627|NCT00453986|Secondary|Number of Subjects With Anti-tetanus Antibody Concentrations Equal to or Above the Cut-off Value of 0.1 International Unit Per Milliliter (IU/mL), for Subjects in the Flu Vaccine Cohort|Blood samples were taken on subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).|Prior to and one month after vaccination (at Month 0 and Month 1).|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.||Subjects|||Number
737628|NCT00453986|Secondary|Anti-tetanus Antibody Concentrations, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.|Concentrations were expressed in geometric mean concentrations in International unit per milliliter (IU/mL) and were calculated on all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.|Prior to and one month after vaccination (at Month 0 and Month 1).|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.||IU/mL||95% Confidence Interval|Geometric Mean
737629|NCT00453986|Secondary|Number of Subjects With Anti-tetanus Antibody Concentrations Equal to or Above the Cut-off Value of 0.1 International Unit Per Milliliter (IU/mL), in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.|Blood samples were taken on all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.|Prior to and one month after vaccination (at Month 0 and Month 1).|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.||subjects|||Number
737630|NCT00453986|Secondary|Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, for Subjects in the Flu Vaccine Cohort|Vaccine response was defined as a rSBA titer of at least 1:32 in initially seronegative subjects (<1:8) and as 4-fold increase in titer in initially seropositive subjects (≥ 1:8). A seronegative subject had antibody titer >1:8 and a seropositive subject had antibody titer ≥1:8 prior to vaccination. Vaccine response was assessed for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).|One month after vaccination (at Month 1)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.||Subjects|||Number
737631|NCT00453986|Secondary|rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.|Titers were expressed as geometric mean antibody titers and were calculated on all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.|Prior to and one month after vaccination (at Month 0 and Month 1).|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.||Titers||95% Confidence Interval|Geometric Mean
737632|NCT00453986|Secondary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.|Assay cut-off values assessed were ≥1:8 and ≥1:128. Blood samples were taken on all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.|Prior to and one month after vaccination (at Month 0 and Month 1).|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.||Subjects|||Number
737633|NCT00453986|Secondary|rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, for Subjects in the Flu Vaccine Cohort|Titers were expressed as geometric mean antibody titers and were calculated on all subjects receiving 1 dose of Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving 1 dose of Nimenrix vaccine among all the manufactured lots (pooled groups from the Flu vaccine cohort) and on subjects receiving 1 dose of Mencevax ACWY vaccine (in the Flu vaccine cohort).|Prior to and one month after vaccination (at Month 0 and Month 1).|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.||Titers||95% Confidence Interval|Geometric Mean
737634|NCT00453986|Secondary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort|Assay cut-off values assessed were ≥1:8 and ≥1:128. Blood samples were taken on all subjects receiving 1 dose of Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving 1 dose of Nimenrix vaccine among all the manufactured lots (pooled groups from the Flu vaccine cohort) and on subjects receiving 1 dose of Mencevax ACWY vaccine (in the Flu vaccine cohort).|Prior to and one month after vaccination (at Month 0 and Month 1).|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.||Subjects|||Number
737635|NCT00453986|Secondary|rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, in Each of the 3 Lot Groups.|Titers were expressed as geometric mean antibody titers and were calculated on all subjects of both cohorts receiving 1 dose of Nimenrix vaccine lot A, B or C.|Prior to vaccination (at Month 0).|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.||Titers||95% Confidence Interval|Geometric Mean
737637|NCT00453986|Primary|Number of Seroprotected Subjects HI Antibody Titers for Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine.|Seroprotection was defined as the percentage of subjects with a serum HI titer ≥ 1:40 after vaccination (for each vaccine strain) that usually is accepted as indicating protection. Seroprotection was calculated on all subjects receiving 1 dose of Fluarix vaccine in the Flu vaccine cohort. The 3 influenza virus strains represented in the vaccine were A/H1N1, A/H3N2, and B.|Prior to and one month after vaccination (at Month 0 and Month 1)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.||Subjects|||Number
737638|NCT00453986|Primary|Seroconversion Factor for HI Antibody Titers for Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine.|Conversion factor defined as the fold increase in serum HI Geometric Mean Titers 1 month after vaccination compared to pre-vaccination, for each vaccine strain. Conversion factor was calculated on all subjects receiving 1 dose of Fluarix vaccine in the Flu vaccine cohort. The 3 influenza virus strains represented in the vaccine were A/H1N1, A/H3N2, and B.|One month after vaccination (at Month 1)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.||Fold increase in serum HI GMTs||95% Confidence Interval|Mean
737639|NCT00453986|Primary|Number of Seroconverted Subjects for HI Antibody Titers for Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine.|"Seroconversion was defined as the percentage of subjects with either a pre-vaccination HI titer <1:10 and a post-vaccination titer >1:40, or a pre-vaccination titer >1:10 and a minimum 4-fold increase at post-vaccination titer, for each vaccine strain.
Seroconversion was calculated on all subjects receiving 1 dose of Fluarix vaccine in the Flu vaccine cohort. The 3 influenza virus strains represented in the vaccine were A/H1N1, A/H3N2, and B."|One month after vaccination (at Month 1)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.||Subjects|||Number
737640|NCT00453986|Primary|Number of Subjects With Serum Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine.|Titers were expressed as geometric mean antibody titers and were calculated on all subjects receiving 1 dose of Fluarix vaccine in the Flu vaccine cohort. The 3 influenza virus strains represented in the vaccine were A/H1N1, A/H3N2, and B.|Prior to and one month after vaccination (at Month 0 and Month 1).|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.||Titers||95% Confidence Interval|Geometric Mean
737641|NCT00453986|Primary|rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers, in Subjects Receiving the Nimenrix Lot A + Fluarix Vaccines or the Nimenrix Vaccine (Pooled Lots in the Flu Vaccine Cohort)|Titers were expressed as geometric mean antibody titers and were calculated on all subjects receiving 1 dose of Nimenrix vaccine lot A co-administered with Fluarix vaccine and on subjects receiving 1 dose of Nimenrix vaccine among all the manufactured lots (pooled groups from the Flu vaccine cohort).|One month after vaccination (at Month 1)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.||Titers||95% Confidence Interval|Geometric Mean
737642|NCT00453986|Primary|Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.|Vaccine response was defined as a rSBA titer of at least 1:32 in initially seronegative subjects (<1:8) and as 4-fold increase in titer in initially seropositive subjects (≥1:8). A seronegative subject had antibody titer below 1:8 prior to vaccination and a seropositive subject had antibody titer equal to or above 1:8 prior to vaccination. Vaccine response was assessed for subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.|One month after vaccination (at Month 1)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.||Subjects|||Number
737643|NCT00453986|Primary|Serum Bactericidal Assay (Performed Using Baby Rabbit Complement) for Neisseria Meningitidis Serogroups A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers, in Each of the 3 Lot Groups.|Titers were expressed as geometric mean antibody titers and were calculated on all subjects from both cohorts receiving 1 dose of Nimenrix vaccine lot A, B or C.|One month after vaccination (at Month 1)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.||Titers||95% Confidence Interval|Geometric Mean
737644|NCT00453999|Secondary|Change in Amount of Influenza Virus in Nose and Throat (Influenza A and B Combined)|Reduction in viral shedding, assessed as the change in quantitative viral titers and defined as the time-weighted change from baseline in TCID50/mL, was summarized for each treatment group.|Baseline, and 12, 24, 36, 48, 72, and 96 hours|Among the 122 subjects with confirmed influenza (intent-to-treat infected [ITTI]) population, a total of 112 subjects had positive virus cultures obtained from baseline nasopharyngeal specimens.||log10 TCID50/mL||Standard Deviation|Mean
737645|NCT00453999|Secondary|Time to Hospital Discharge (Kaplan-Meier Estimate)|Time to discharge from hospital was estimated using the method of Kaplan Meier. Subjects who were not discharged from the hospital were censored at the time of their last assessment.|14 days|The intent-to-treat infected (ITTI) population included all subjects who were randomized, received at least 1 dose of study drug, and had confirmed influenza infection by viral culture, PCR, and/or paired acute and convalescent serology specimens that demonstrated at least a 4-fold increase in antibody titer against influenza A or B.||hours||95% Confidence Interval|Median
737665|NCT00454142|Secondary|Pharmacokinetic Study: Volume of Distribution (Vd/F/Dose) on Day 1|Volume of distribution (Vd/F/dose) were measured on day 1 for 26 evaluable participants. Blood sampling was done at zero (pre dose), 0.5 hr, 1, 2, 3, 4, 5, 6, 8 hrs after first dose.|Day 1 of treatment|||mL/mg||Full Range|Median
737646|NCT00453999|Secondary|Incidence of Clinical Relapse of Influenza After Treatment (Number of Participants Experiencing Relapse During the Study)|The number of subjects with clinical relapse, defined as changes in 2 or more signs of clinical stability to values outside the range of normalization criteria for a duration of at least 12 consecutive hours after clinical stability had been attained, were summarized by treatment group.|14 days|The intent-to-treat infected (ITTI) population included all subjects who were randomized, received at least 1 dose of study drug, and had confirmed influenza infection by viral culture, PCR, and/or paired acute and convalescent serology specimens that demonstrated at least a 4-fold increase in antibody titer against influenza A or B.||participants|||Number
737647|NCT00453999|Secondary|Time to Resumption of Ability to Perform Usual Activities (Kaplan-Meier Estimate)|Changes in each subject’s ability to perform usual activities as determined from the visual analog scale (0 to 10, where 0 indicated subject was unable to perform usual activities at all and 10 indicated subject was able to perform all usual activities fully) were summarized by study visit and treatment group. The time to resumption of a subject’s ability to perform usual activities was estimated using the method of Kaplan Meier. Subjects who did not return to the pre-study level of performance of usual activities were censored at the time of their last assessment. (Note: N is the number of ITTI participants with available data).|14 days|The intent-to-treat infected (ITTI) population included all subjects who were randomized, received at least 1 dose of study drug, and had confirmed influenza infection by viral culture, PCR, and/or paired acute and convalescent serology specimens that demonstrated at least a 4-fold increase in antibody titer against influenza A or B.||hours||95% Confidence Interval|Median
737648|NCT00453999|Secondary|Change From Baseline in Scores of Symptoms of Influenza|Descriptive statistics for the change from baseline in each of the 7 symptoms of influenza (cough; sore throat; nasal congestion; myalgia [aches and pains]; headache; feverishness; and fatigue, each graded on a 4-point severity scale [0, absent; 1, mild; 2, moderate; 3, severe]) were tabulated by treatment group. Missing data were excluded.|Baseline, Days 2, 3, 4, 5, 10, and 14|The intent-to-treat infected (ITTI) population included all subjects who were randomized, received at least 1 dose of study drug, and had confirmed influenza infection by viral culture, PCR, and/or paired acute and convalescent serology specimens that demonstrated at least a 4-fold increase in antibody titer against influenza A or B.||units on a scale||Standard Deviation|Mean
737649|NCT00453999|Primary|Time to Clinical Stability (Kaplan-Meier Estimate)|Time to clinical stability was summarized overall and for individual clinical signs for each treatment group using the method of Kaplan Meier. Subjects who did not experience clinical stability were censored at the date of their last non-missing assessment during the study (whether this assessment occurred as an inpatient or as an outpatient).|14 days|The intent-to-treat infected (ITTI) population included all subjects who were randomized, received at least 1 dose of study drug, and had confirmed influenza infection by viral culture, PCR, and/or paired acute and convalescent serology specimens that demonstrated at least a 4-fold increase in antibody titer against influenza A or B.||hours||95% Confidence Interval|Median
737650|NCT00454051|Secondary|Physician's Overall Assessment of Treatment Effectiveness|The Physician's overall assessment of treatment effectiveness was graded 1-5 as 1 = Excellent asthma control (complete control) 2 = Good asthma control (marked improvement) 3 = Moderate asthma control (discernible, but limited improvement) 4 = Poor asthma control (no appreciable change) 5 = Very poor asthma control (worsening)|After 16 weeks of treatment|The ITT population included all randomized participants who received at least one dose of study drug and from whom at least one efficacy measurement was obtained. Complete data for 26 of the total 30 participants was recorded.||participants|||Number
737651|NCT00454051|Secondary|Change From Baseline in the Morning Daily Peak Expiratory Flow (PEF)|Peak Expiratory Flow (PEF) was measured every morning using a peak flow meter, and was recorded in the patient diary. For this analysis, the mean morning PEF during the 4-week screening period prior to randomizaton is compared with the mean morning PEF during the last 4 weeks of study treatment (Weeks 12 - 16).|Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16)|The intent-to-treat population included all randomized participants who received at least one dose of study drug and from whom at least one efficacy measurement was obtained.||liters per minute||Standard Deviation|Mean
737652|NCT00454051|Secondary|Change From Baseline in the Number of Unscheduled Clinic Visits|Participants maintained a diary to record the number of unscheduled clinic visits during the study. For this analysis, the number of unscheduled visits during the 4 week screening period prior to randomization is compared with the number of unscheduled visits during the last 4 weeks on treatment (Weeks 12 - 16).|Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16)|The intent-to-treat population included all randomized participants who received at least one dose of study drug and from whom at least one efficacy measurement was obtained.||unscheduled visits||Standard Deviation|Mean
737653|NCT00454051|Secondary|Change From Baseline in the Number of Days With Hospitalizations|Participants maintained a diary to record the number of days with hospitalizations during the study. For this analysis, the number of days with hospitalizations during the screening period (4 weeks prior to randomization) was compared with the number of days with hospitalizations during the last 4 weeks on study treatment (Weeks 12 - 16).|Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16)|The intent-to-treat population included all randomized participants who received at least one dose of study drug and from whom at least one efficacy measurement was obtained.||days||Standard Deviation|Mean
737654|NCT00454051|Secondary|Change From Baseline in the Number of Days With Absence From School or Work Due to Asthma Symptoms|Participants maintained a diary to record the number of days with absence from school or work due to asthma symptoms. For this analysis, the number of days with absence from school or work in the four weeks prior to randomization (screening period) were compared with the number of absence days during the last 4 weeks on study treatment (Weeks 12 - 16).|Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16)|The intent-to-treat population included all randomized participants who received at least one dose of study drug and from whom at least one efficacy measurement was obtained.||days||Standard Deviation|Mean
737666|NCT00454142|Secondary|Pharmacokinetic Study: Area Under Curve (AUC) 0-24h/Dose on Day 28|AUC 0-24h/dose were measured on day 28 for 26 evaluable participants. Blood sampling was done at zero (pre dose), 0.5 hr, 1, 2, 3, 4, 5, 6, 8 and 24 hrs after day 28 dose.|Day 28 of treatment|||hr*ng/mL/mg||Full Range|Median
737655|NCT00454051|Secondary|Change From Baseline in the Number of Days With Impairment in Daily Activities Per Week|"Impairment was defined as days with physical activity considered as limited (or not normal) according to patient's assessment and was recorded in a patient daily diary. For this analysis, the mean number of days with impairment per week during the 4 week screening period prior to randomization was compared with the mean number of days with impairment per week during the last 4 weeks on study treatment (Weeks 12 - 16)."|Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16)|The intent-to-treat population included all randomized participants who received at least one dose of study drug and from whom at least one efficacy measurement was obtained.||days per week||Standard Deviation|Mean
737656|NCT00454051|Secondary|Change From Baseline in the Number of Nights With Awakenings Per Week|Participants maintained a diary to record the number of nights with awakenings due to asthma symptoms per week. For this analysis, the mean number of nights with awakenings per week during the 4 week screening period prior to randomization was compared with the mean number of nights with awakenings per week during the last 4 weeks of study treatment (Weeks 12 - 16).|Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16)|The intent-to-treat population included all randomized participants who received at least one dose of study drug and from whom at least one efficacy measurement was obtained.||nights with awakenings per week||Standard Deviation|Mean
737657|NCT00454051|Secondary|Change From Baseline in the Number of Puffs of Rescue Medication Per Week|Participants maintained a diary to record the daytime number of puffs of rescue Short-acting B2 agonist (SABA) used to treat asthma symptoms per week. This analysis compares the mean number of puffs of rescue medication per week during the 4 week screening period prior to randomization to the mean number of puffs per week during the last 4 weeks on study treatment (Weeks 12 - 16).|Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16)|The intent-to-treat population included all randomized participants who received at least one dose of study drug and from whom at least one efficacy measurement was obtained.||puffs per week||Standard Deviation|Mean
737658|NCT00454051|Primary|Change (%) From Baseline in Mean Fluorescence Intensity of FcεRI After 16 Weeks of Treatment With Omalizumab as Compared With Placebo|Blood was drawn from participants at baseline and at week 16. Basophils and dendritic cells expressing FcεRI were counted and the percentage was calculated. Fluorescence was used to label FcεRI so that they could be visualized. The greater the fluorescence intensity the greater FcεRI expression. The change from baseline is described by the difference (%) between the baseline value, before the first study drug administration, and the value observed at the end of study, expressed as a percent of the baseline value.|Baseline and Week 16|The Intent-to-treat (ITT) population analyzable for FcεRI expression was a subset of the ITT population and included the 27 participants with accurate measurements before and after 16 weeks of treatment.||percent change in fluorescence intensity||Standard Deviation|Mean
737659|NCT00454051|Secondary|Change From Baseline in the Number of Days With Asthma Symptoms Per Week|Participants maintained a diary to record the number of days with daytime asthma symptoms per week. This analysis compares the mean number of days per week with asthma symptoms during the 4-week screening period prior to randomization with the mean number of days per wek with asthma symptoms in the last 4 weeks of study treatment (Weeks 12 -16).|Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16)|The intent-to-treat population included all randomized participants who received at least one dose of study drug and from whom at least one efficacy measurement was obtained.||days per week||Standard Deviation|Mean
737660|NCT00454051|Secondary|Change (%) From Baseline in the Mean Fluorescence Intensity of FcεRI After 4, 8, 12 and 16 Weeks of Treatment|Blood was drawn from a sub-group of participants at weeks 4, 8, 12, and 16. Basophils and dendritic cells expressing FcεRI were counted and the percentage was calculated. Fluorescence was used to label FcεRI so that they could be visualized. The change from baseline is described by the difference (%) between the baseline value, before the first study drug administration, and the value observed at the specified time point, expressed as a percent of the baseline value.|Baseline, Weeks 4, 8, 12, and 16|A subset of the ITT population analyzable for FcεRI expression at select sites had repeat measurements of FcεRI expression at all time points.||% change in fluorescence intensity||Standard Deviation|Mean
737661|NCT00454051|Secondary|Change (%) From Baseline in Percent of Basophils and Dendritic Cells Expressing FcεRI After 4, 8, 12 and 16 Weeks of Treatment|Blood was drawn from a sub-group of participants at weeks 4, 8, 12, and 16. Basophils and dendritic cells expressing FcεRI were counted and the percentage was calculated. Fluorescence was used to label FcεRI so that they could be visualized. The change from baseline is described by the difference (%) between the baseline value, before the first study drug administration, and the value observed at the specified time point, expressed as a percent of the baseline value.|Baseline, Weeks 4, 8, 12 and 16|A subset of the ITT population analyzable for FcεRI expression at select sites had repeat measurements of FcεRI expression at all time points.||percent change in cells expressing FcεRI||Standard Deviation|Mean
737662|NCT00454051|Primary|Change (%) From Baseline in FcεRI (High-affinity IgE Receptor) Expression on Blood Basophils and Dendritic Cells After 16 Weeks of Treatment With Omalizumab as Compared With Placebo|Blood was drawn from participants at baseline and at Week 16. Basophils and dendritic cells expressing FcεRI were counted and the percentage was calculated. Fluorescence was used to label FcεRI so that they could be visualized. The greater the fluorescence intensity the greater FcεRI expression. The change from baseline is described by the difference (%) between the baseline value, before the first study drug administration, and the value observed at the end of study, expressed as a percent of the baseline value.|Baseline and Week 16|The Intent-to-treat (ITT) population analyzable for FcεRI expression was a subset of the ITT population and included the 27 participants with accurate measurements before and after 16 weeks of treatment.||percent change in FcεRI expression||Standard Deviation|Mean
737663|NCT00454116|Primary|Number of Patients With an Objective Disease Progression Event|Number of patients with objective disease progression or death (by any cause in the absence of objective progression)|Tumour assessments carried out at screening and then as per site clinical practice until objective progression. The only additional mandatory tumour assessment visit is at the point of data cut-off (28 March 2008 +/-3 days)|||Participants|||Number
737664|NCT00454142|Secondary|Pharmacokinetic Study: Volume of Distribution at Steady State (Vss/F/Dose) on Day 28|Volume of distribution at steady state (Vss/F/Dose) were measured on day 28 for 26 evaluable participants. Blood sampling was done at zero (pre dose), 0.5 hr, 1, 2, 3, 4, 5, 6, 8 and 24 hrs after day 28 dose.|Day 28 of treatment|||mL/mg||Full Range|Median
737668|NCT00454142|Secondary|Pharmacokinetic Study: Percentage of Participants With Trough Concentration at Steady State (Day 28) Above 15 µg/mL|Pazopanib pharmacokinetic parameters were estimated on Day 1 and Day 28 (steady state). Trough concentration of pazopanib was measured on Day 28 with blood sampling at zero (pre dose), 0.5 hr, 1, 2, 3, 4, 5, 6, 8 and 24 hrs after Day 28 dose.|Day 28 of treatment|Patients (total 26) with both Day 1 and Day 28 pharmacokinetic parameters were included.The trough concentration of pazopanib on Day 28 was observed to be above 15ug/ml in approximately 92% of patients at steady state.||percentage of participants|||Number
737669|NCT00454142|Secondary|Pharmacodynamic Study: Tumor Blood Flow on Day 28|DCE-CT was performed on Day 28 and tumor blood flow was measured. 19 of 33 patients had evaluable DCE-CT data.|28 days post treatment|||ml/100ml/min||Standard Deviation|Mean
737670|NCT00454142|Secondary|Pharmacodynamic Study: Tumor Blood Flow at Baseline|Dynamic-contrast enhanced computed tomography (DCE-CT) was performed at baseline and Day 28, tumor blood flow was measured.19 of 33 patients had evaluable DCE-CT data.|Pretreatment|||ml/100ml/min||Standard Deviation|Mean
737671|NCT00454142|Secondary|Toxicity Profile: Percentage of Participants With Significant (Grade 3/4) Related Adverse Event (AE)|The frequencies of grade 3/4 related toxicities were recorded among all participants, and the percentage of participants who experienced significant AEs were reported.|From the time of first treatment with pazopanib hydrochloride to up to 30days after completion of treatment|||percentage of participants|||Number
737672|NCT00454142|Secondary|Overall Survival||From date of enrollment to the study to the date of death from any cause or to the date when the patient was last known to be alive, up to 3 years.|||months||95% Confidence Interval|Median
737673|NCT00454142|Primary|Clinical Benefit Rate|Clinical benefit rate (CBR) as defined by Response Evaluation Criteria in Solid Tumors (RECIST ver 1.0) and assessed by CT or MRI. CBR includes 1) Complete response (CR): disappearance of all lesions; 2) partial response (PR): >=30% decrease in the sum of the longest diameter of target lesions and 3) stable disease (SD): non-PR and non progressive disease.|12 weeks of treatment|||percentage of participants||95% Confidence Interval|Number
737674|NCT00454142|Secondary|Progression-free Survival|Progression will be evaluated in this study using the new international criteria proposed by RECIST Committee. The sample proportion and associated 95% confidence interval will be reported.|From the date of enrollment to the date of first documented progression or death, whichever occurs first, or to the date when the patient was last known to be alive, up to 3 years.|||months||95% Confidence Interval|Median
737675|NCT00454142|Secondary|Response Rate (PR)|Per response evaluation criteria in solid tumors (RECIST v1.0) and assessed by MRI or CT: Partial response (PR), >=30% decrease in the sum of the longest diameter of target lesions and non-PD (PD: progressive disease) of non-target lesions.|12 weeks of treatment|||percentage of participants|||Number
737676|NCT00454181|Secondary|Investigator Assessment Regarding Global Oral Changes.|"Number of subjects with improvement from baseline to week 24 in global oral health as rated by the attending investigator. Scale was subjective with 3 choices: improved, worsened, or unchanged."|24 weeks, from baseline to the end of treatment|||participants|||Number
737677|NCT00454181|Secondary|Investigator Assessment Regarding Changes in Warts|"Number of subjects with improvement in oral warts from baseline to week 24 as rated by the attending investigator. Scale was subjective with 3 choices: improved, worsened, or unchanged."|24 weeks, from baseline to the end of treatment|||participants|||Number
737678|NCT00454181|Secondary|Subject Questionnaire Regarding Global Oral Changes|"Number of subjects reporting change in global oral health from baseline to week 24 as better. Scale was subjective with 3 choices: better, worse, or unchanged."|24 weeks, from baseline to end of treatment|||participants|||Number
737679|NCT00454181|Secondary|Subject Questionnaire Regarding Changes in Warts|"Number of subjects reporting change in oral warts from baseline to week 24 as better. Scale was subjective with 3 choices: better, worse, or unchanged."|24 weeks, from baseline to the end of treatment|||participants|||Number
737680|NCT00454181|Secondary|Total Surface Area of the Lips Covered by Warts|Number of subjects with a 75% or greater decrease from baseline to week 24 in total lip wart area|24 weeks, from baseline to the end of treatment|Per protocol - only a sub-set of subjects had lip warts at study entry||participants|||Number
737681|NCT00454181|Primary|Change in Total Oral Mucosal Area Covered by Warts.|Number of subjects with a 75% or greater decrease from baseline to week 24 in total oral wart area|24 weeks, from baseline to the end of treatment|Per protocol||participants|||Number
737682|NCT00454194|Secondary|Confirmed Response Rate (Complete Response and Partial Response) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)|"A confirmed tumor response was defined as a complete response (CR) or partial response (PR) noted as the objective status on 2 consecutive evaluations at least 6 weeks apart.
Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria:
Complete Response (CR): disappearance of all target lesions;
Partial Response (PR) 30% decrease in sum of longest diameter of target lesions;
Progressive Disease (PD): 20% increase in sum of longest diameter of target lesions;
Stable Disease (SD): small changes that do not meet above criteria."|Up to 5 years|All participants who met the eligibility criteria and started the treatment.||percentage of participants|||Number
737683|NCT00454194|Secondary|Number of Participants With at Least One Grade 3 or Above Adverse Events Assessed by NCI CTCAE v4.0|Adverse events were assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grading: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death. The maximum grade for each type of adverse events were recorded for each patient.|Up to 3 years|All participants who met the eligibility criteria and started the treatment.||participants|||Number
737684|NCT00454194|Secondary|Duration of Response|"Duration of response was defined as the time from the date at which the patient’s earliest best objective status was first noted to be either a complete response (CR) or partial response (PR) to the earliest date progression was documented.
Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria:
Complete Response (CR): disappearance of all target lesions;
Partial Response (PR) 30% decrease in sum of longest diameter of target lesions;"|Up to 5 years|All participants who met the eligibility criteria, have started the study treatment and had confirmed CR or PR.||months||95% Confidence Interval|Median
737685|NCT00454194|Secondary|Time to Treatment Failure|Time to treatment failure was defined as the time from date of randomization to the date at which the patient was removed from the treatment due to progression, toxicity, refusal or other medical problems.|Up to 5 years|All participants who met the eligibility criteria and ended the treatment.||months||95% Confidence Interval|Median
737687|NCT00454194|Primary|Progression-free Survival|The progression-free survival (PFS) was defined as the time from date of randomization to the documentation of disease progression or death as a result of any cause, whichever comes first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Time from randomization to the disease progression or death (up to 5 years)|All participants who met the eligibility criteria and started the treatment.||months||95% Confidence Interval|Median
737688|NCT00454207|Secondary|Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)|The total number of participants with laboratory test abnormalities without regard to baseline abnormality.|Baseline up to 1.3 years|All subjects who received at least one dose of the study medication and had any evaluable laboratory test data after treatment.||participants|||Number
737689|NCT00454207|Secondary|The Average Plasma Trough Concentration (Ctrough) of Sildenafil|The average plasma trough concentration of sildenafil was calculated from the observed value before administration of the drug in each participants.|Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing|||nanograms/milliliter||Standard Deviation|Mean
737690|NCT00454207|Secondary|The Average Plasma Concentration (Css,av) of Sildenafil at Steady State|The average plasma concentration of sildenafil at steady state was calculated from the area under the curve from time 0 to 8 hour/dosing interval (8 hours).|Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing|||nanograms/milliliter||Standard Deviation|Mean
737691|NCT00454207|Secondary|The Area Under the Curve (AUC) From Time 0 to Time 8 Hour of Sildenafil and Sildenafil's Metabolite, UK-103,320|The area under the curve from time 0 to time 8 hour was calculated from area under the curve in each perticipant on the date of blood sampling using the linear/log trapezoidal rule|Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing|||nanogram*hour/milliliter||Standard Deviation|Mean
737692|NCT00454207|Secondary|Time to First Occurrence of Maximum Plasma Concentrations (Tmax) of Sildenafil and Sildenafil's Metabolite, UK-103,320|Time to first occurrence of maximum plasma concentrations were calculated from the observed value of plasma concentrations in each participant.|Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing|||hours||Standard Deviation|Mean
737693|NCT00454207|Secondary|Maximum Plasma Concentrations (Cmax) of Sildenafil and Sildenafil's Metabolite, UK-103,320|Maximum plasma concentrations was calculated from the observed value of plasma concentrations in each participant|Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing|||nanograms/milliliter||Standard Deviation|Mean
737694|NCT00454207|Secondary|Changes in the the Plasma Brain Natriuretic Peptide Level From Baseline at Week 12 in Participants Who Newly Enterd the Study From Part II|Change：Plasma brain natriuretic peptide level at Week 12 minus plasma brain natriuretic peptide level at baseline|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.||picograms/milliliter||Standard Deviation|Mean
737695|NCT00454207|Secondary|Changes in the BORG Dyspnoea Score From Baseline at Week 12 in Participants Who Newly Entered the Study From Part II|Change：BORG dyspnoea score at Week 12 minus BORG dyspnoea score at baseline. BORG dyspnoea score:Scale 0 (no breathlessness at all) to 10 (maximum). The score reflected the maximum degree of dyspnoea that the participants experienced at any time during the 6-minute walk distance.|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.||scores on a scale||Standard Deviation|Mean
737696|NCT00454207|Secondary|Change in the World Health Organization (WHO) Functional Class From Baseline at Week 12 in Participants Who Newly Entered the Study From Part II|The cross-tabulation table on the WHO functional classes of pulmonary arterial hypertension at baseline and Week 12. The WHO functional classes of pulmonary arterial hypertension:Class I (pulmonary arterial hypertension patients with no limitation in physical activity) to Class IV (pulmonary arterial hypertension patients who can not perform a physical activity without any symptoms).|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.||participants|||Number
737697|NCT00454207|Secondary|Change in the 6-minute Walk Distance From Baseline at Week 12 in Participants Who Newly Entered the Study From Part II|Change：6-minute walk distance at Week 12 minus 6-minute walk distance at baseline. The 6-minute walk distance:Total distance walked during the 6- minute walk test.|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.||meters||Standard Deviation|Mean
737698|NCT00454207|Secondary|Changes in the the Plasma Brain Natriuretic Peptide Level From Baseline at Week 4, Week 8 and Week 12 in Participants Who Entered the Study From Part I|Change：Plasma brain natriuretic peptide level at Week 4, Week 8 and Week 12 minus plasma brain natriuretic peptide level at baseline|Baseline, Week 4, Week 8, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward (Week 12).||picograms/milliliter||Standard Deviation|Mean
737699|NCT00454207|Secondary|Changes in the BORG Dyspnoea Score From Baseline at Week 8 and Week 12 in Participants Who Entered the Study From Part I|Change：BORG dyspnoea score at Week 8 and Week 12 minus BORG dyspnoea score at baseline. BORG dyspnoea score:Scale 0 (no breathlessness at all) to 10 (maximum). The score reflected the maximum degree of dyspnoea that the participants experienced at any time during the 6-minute walk distance.|Baseline, Week 8, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward (Week 12).||scores on a scale||Standard Deviation|Mean
737700|NCT00454207|Secondary|Changes in the World Health Organization (WHO) Functional Class of Pulmonary Arterial Hypertension From Baseline at Weeks 12 in Participants Who Entered the Study From Part I|The cross-tabulation table on the WHO functional classes of pulmonary arterial hypertension at baseline and Week 12. The WHO functional classes of pulmonary arterial hypertension:Class I (pulmonary arterial hypertension patients with no limitation in physical activity) to Class IV (pulmonary arterial hypertension patients who can not perform a physical activity without any symptoms).|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.||participants|||Number
737701|NCT00454207|Secondary|Change in the Partial Pressure of Mixed Venous Oxygen From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change：Partial pressure of mixed venous oxygen at Week 12 minus partial pressure of mixed venous oxygen at baseline.|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.||mmHg||Standard Deviation|Mean
737702|NCT00454207|Secondary|Change in the Arterial Oxygen Partial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change：Arterial oxygen partial pressure at Week 12 minus arterial oxygen partial pressure at baseline.|baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.||mmHg||Standard Deviation|Mean
737703|NCT00454207|Secondary|Change in the Arterial Oxygen Saturation From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change：Arterial oxygen saturation at Week 12 minus arterial oxygen saturation at baseline.|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.||percent saturation||Standard Deviation|Mean
737704|NCT00454207|Secondary|Change in the Mixed Venous Oxygen Saturation From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change：Mixed venous oxygen saturation at Week 12 minus mixed venous oxygen saturation at baseline.|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.||percent saturation||Standard Deviation|Mean
737705|NCT00454207|Secondary|Change in the Systemic Vascular Resistance Index From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change：Systemic vascular resistance index at Week 12 minus systemic vascular resistance index at baseline.|baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.||dyne*second/centimeter^5/meter^2||Standard Deviation|Mean
737706|NCT00454207|Secondary|Change in the Systemic Vascular Resistance From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change：Systemic vascular resistance at Week 12 minus systemic vascular resistance at baseline.|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.||dyne*second/centimeter^5||Standard Deviation|Mean
737707|NCT00454207|Secondary|Change in the Pulmonary Vascular Resistance Index From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change:Pulmonary vascular resistance index at Week 12 minus pulmonary vascular resistance index at baseline.|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.||dyne*second/centimeter^5/meter^2||Standard Deviation|Mean
737708|NCT00454207|Secondary|Change in the Heart Rate From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change：Heart rate at Week 12 minus heart rate at baseline.|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.||beats/minute||Standard Deviation|Mean
737709|NCT00454207|Secondary|Change in the Cardiac Index From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change：Cardiac index at Week 12 minus cardiac index at baseline.|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.||liter/minute/meter^2||Standard Deviation|Mean
737710|NCT00454207|Secondary|Change in the Right Atrial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change：Right atrial pressure at Week 12 minus right atrial pressure at baseline.|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.||mmHg||Standard Deviation|Mean
737711|NCT00454207|Secondary|Change in the Pulmonary Capillary Wedge Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change：Pulmonary capillary wedge pressure at Week 12 minus pulmonary capillary wedge pressure at baseline.|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.||mmHg||Standard Deviation|Mean
737712|NCT00454207|Primary|Change in the Cardiac Output From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change：Cardiac output at Week 12 minus cardiac output at baseline|Baseline, week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.||liter/minute||Standard Deviation|Mean
737713|NCT00454207|Secondary|Change in the Mean Systemic Blood Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I|"Mean systemic blood pressure:diastolic blood pressure+(systolic blood pressure-diastolic blood pressure)/3.
Change：Mean systemic blood pressure at Week 12 minus mean systemic blood pressure at baseline."|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.||mmHg||Standard Deviation|Mean
737714|NCT00454207|Secondary|Change in the Diastolic Systemic Blood Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change：Diastolic systemic blood pressure at Week 12 minus diastolic systemic blood pressure at baseline.|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.||mmHg||Standard Deviation|Mean
737715|NCT00454207|Secondary|Change in the Systolic Systemic Blood Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change：Systolic systemic blood pressure at Week 12 minus systolic systemic blood pressure at baseline.|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.||mmHg||Standard Deviation|Mean
737718|NCT00454207|Secondary|Change in the 6-minute Walk Distance From Baseline at Week 8 in Participants Who Entered the Study From Part I|"Change：6-minute walk distance at Week 8 minus 6-minute walk distance at baseline.
The 6-minute walk distance:Total distance walked during the 6- minute walk test."|Baseline, Week 8|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline.||meters||Standard Deviation|Mean
737719|NCT00454207|Primary|Change in the Pulmonary Vascular Resistance From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change：Pulmonary vascular resistance at Week 12 minus pulmonary vascular resistance at baseline|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.||dyne·second/centimeter^5||Standard Deviation|Mean
737720|NCT00454207|Primary|Change in the Mean Pulmonary Arterial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change:Mean pulmonary arterial pressure at Week 12 minus mean pulmonary arterial pressure at baseline.|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.||mmHg||Standard Deviation|Mean
737721|NCT00454207|Primary|Change in the 6-minute Walk Distance From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change：6-minute walk distance at Week 12 minus 6-minute walk distance at baseline. The 6-minute walk distance:total distance walked during the 6-minute walk test.|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.||meters||Standard Deviation|Mean
737722|NCT00454246|Secondary|Number of Participants Assessed for AEs and SAEs|The adverse events are captured in the adverse event and serious adverse event section of this database.|First dose of medication through 15 days post last dose (up to 8 months)|Safety Population||participants|||Number
737723|NCT00454246|Secondary|Dose Adjustments|Efficacy analyses were not performed.|5 months post-randomization through onset of dialysis, and post-dialysis initiation through study end.|||participants|||Number
737724|NCT00454246|Primary|Percentage of Patients Able to Maintain Hemoglobin (Hb) Within 10-12 g/dL|Efficacy analyses were not performed.|6-7 months post initiation of dialysis|||percentage of participants|||Number
737725|NCT00454324|Secondary|Number of Individuals With Adverse Events|Drug toxicities will be evaluated during treatment period and 30 days post treatment. Toxicities will be assessed using Common Terminology Criteria for Adverse Events (CTCAE 3.0) criteria. Grade 3 or 4 adverse events were reported|10 weeks|||Participants|||Count of Participants
737726|NCT00454324|Secondary|Progression Free Survival (PFS)|Defined as the time between trial enrollment to disease progression or death (whichever occurs first) or date of last contact|Through the end of the study, an average of approximately 8 months|||Months||95% Confidence Interval|Median
737727|NCT00454324|Secondary|1-year Overall Survival (OS)|Percentage of participants from the start of treatment with the disease that are still alive.|every 12 weeks for 1 year|||percentage of participants||95% Confidence Interval|Number
737728|NCT00454324|Primary|Overall Response Rate|Radiological imaging should be performed every 12 weeks, to ascertain the overall (or objective) response rate (Complete Response or Partial Response) according to the RECIST guidelines. Complete Response (CR) - Disappearance of all target lesions. Partial Response (PR) - at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Overall Response Rate = CR+PR.|12 weeks|||percentage of participants||95% Confidence Interval|Number
737729|NCT00454363|Secondary|Change in Tumor Blood Flow Assessed by Functional CT||Baseline and week 12||||||
737730|NCT00454363|Secondary|Progression Free Survival (PFS)|PFS is defined as the duration of time from start of treatment to time of progression or death.|Baseline to 18 months.|Analysis calculated according to intent to treat.||months||95% Confidence Interval|Median
737731|NCT00454363|Secondary|Plasma Trough Level of GW786034||Baseline and day 28||||||
737732|NCT00454363|Primary|Objective Response Rate (Complete and Partial Response) for Each Cohort Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)|RECIST Criteria: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): 30% decrease in sum of longest diameter (LD) of target lesions, reference baseline sum LD; Progressive Disease (PD): 20% increase in sum of LD of target lesions, reference smallest sum LD recorded since treatment started or appearance 1/> new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum LD since treatment started.|Up to 18 months|RECIST best protocol response by intention to treat. Four participants were not evaluable for response.||participants|||Number
737733|NCT00454532|Primary|Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2)|Best Overall Tumor Response - Independent Radiology Assessment|2 months|||participants|||Number
737734|NCT00454532|Primary|Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2)|Best Overall Tumor Response - Investigator Assessment|2 Months|||participants|||Number
737735|NCT00454532|Primary|Toxicity Based Upon Adverse Events Classifed by the NCI Common Terminology Criteria Version 3 (Phase 1)|Dose-Limiting Toxicities graded according to Common Terminology Criteria for Adverse Events, version 3.0|Monthly|||participants|||Number
737736|NCT00454571|Secondary|Median PSA Progression-free Survival|Kaplan-Meier estimates for PSA progression-free survival will be computed for the pazopanib and active surveillance groups and compared using the log rank test. The outcome measure is median PSA progression-free survival time.|Time from randomization to PSA progression or death from any cause|Patients were taken off study early, so many survival times were censored. At no point during the study did the proportion of subjects who progressed drop to 50%. Thus, it was not possible to calculate median time to PSA progression.|||||
737737|NCT00454571|Primary|Median Time to PSA Progression|The median time to disease progression for the therapy and observation groups will be estimated using the Kaplan-Meier estimate and compared using the log-rank test.|Baseline, every 4 weeks during treatment, and up to 12 months after completion of study treatment|Patients were taken off study early, so many survival times were censored. At no point during the study did the proportion of subjects who progressed drop to 50%. Thus, it was not possible to calculate median time to disease progression.|||||
737738|NCT00454584|Secondary|Difference in Psoriasis Area Severity Index Between Week 12 and That Achieved 12 Weeks After Retreatment (Week R12)|The difference between the PASI score at Week 12 and that achieved after 12 weeks of retreatment. The PASI is the widely used tool for the measurement of severity of psoriasis. This is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) -72 (worst).|Up to Week 52. Retreatment may occur anytime between Week 16 and Week 40 depending on time of losing PGA response. Hence end of 12 weeks of retreatment would be between Week 28 and Week 52, inclusive.|Participants who were randomized to ustekinumab, had a PGA score less than or equal to 2 at Week 12, and were retreated upon losing PGA response (PGA greater than or equal to 3).||Score on a scale||Standard Error|Mean
737739|NCT00454584|Secondary|Number of Participants Achieving a Greater Than or Equal to 90 Percentage Improvement From Baseline in Psoriasis Area and Severity Index (PASI 90) Score at Week 12|Number of participants achieving greater than or equal to 90 percentage improvement from baseline in Psoriasis Area and Severity Index (PASI) at Week 12. PASI is the widely used tool for the measurement of severity of psoriasis. This is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) -72 (worst).|Baseline and Week 12|Intent to treat. All randomly assigned participants were included in the analysis according to the assigned treatment groups. A participant is considered a non-responder if the participant has used any pre-specified prohibited medications, discontinued due to lack of efficacy, or had a missing Week 12 PASI score.||Participants|||Number
737740|NCT00454584|Secondary|Number of Participants With Physician's Global Assessment (PGA) of Cleared or Minimal at Week 12|Number of participants achieving a physician global assessment (PGA) (0-5) of cleared or minimal at Week 12. The PGA is 7-point scale used in clinical trial of various diseases. In this the physician checks the state of the disease and gives them score from 0 (clear) to 5 (severe).|Week 12|Intent to treat. All randomly assigned participants were included in the analysis according to the assigned treatment groups. Participant is considered a non- responder if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy or had a missing PGA score.||Participants|||Number
737741|NCT00454584|Primary|Number of Participants Achieving a Greater Than or Equal to 75 Percentage Improvement From Baseline in Psoriasis Area and Severity Index (PASI 75) Score at Week 12|Number of participants achieving greater than or equal to 75 percentage improvement from baseline in Psoriasis Area and Severity Index (PASI) at Week 12. PASI is the widely used tool for the measurement of severity of psoriasis. This is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) -72 (worst). Baseline visit refers to Week 0.|Baseline and Week 12|Intent to treat. All participants randomized were included in the analysis according to the assigned treatment groups. Participants is considered a non- responder if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy or has missing data at Week 12.||Participants|||Number
737742|NCT00454636|Secondary|Time to Response|Time to Response was defined as the date of start of treatment until the first date of complete response (CR) or a partial response (PR), based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 criteria. CR was defined as the disappearance of all target lesions; for non-target lesions, disappearance of lesions and normal tumor marker levels. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using the baseline sum LD as reference.|Approximately 3.25 years|Safety population: All participants who received at least one dose of study medication. Only participants who reported either a complete response or a partial response were assessed.||days||Standard Deviation|Mean
737743|NCT00454636|Secondary|Duration of Response|Duration of Response was defined as the time of complete response (CR) or partial response (PR) until the first date of recurrent or progressive disease, based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 criteria. CR was defined as the disappearance of all target lesions; for non-target lesions, disappearance of lesions and normal tumor marker levels. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using the baseline sum LD as reference. Progressive disease was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Approximately 3.25 years|Safety population: All participants who received at least one dose of study medication. Only participants who reported either a complete response or a partial response were assessed.||days||Standard Deviation|Mean
737744|NCT00454636|Secondary|Overall Survival (OS)|OS was defined as the time elapsing from the date of the start of treatment until death, or last known follow-up.|Approximately 3.25 years|Safety population: All participants who received at least one dose of study medication.||months||95% Confidence Interval|Median
737745|NCT00454636|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time from the start of treatment to the first documentation of disease progression or death for any cause. Disease progression was based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 criteria and was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Approximately 3.25 years|Safety population: All participants who received at least one dose of study medication.||months||95% Confidence Interval|Median
737746|NCT00454636|Secondary|Overall Response Rate (ORR)|ORR was defined as the percentage of participants achieving either a complete response (CR) or a partial response (PR), based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 criteria. CR was defined as the disappearance of all target lesions; for non-target lesions, disappearance of lesions and normal tumor marker levels. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using the baseline sum LD as reference.|Approximately 3.25 years|Intent-to-Treat (ITT) population: included all participants who received at least one dose of study medication and had baseline and at least one subsequent tumor assessment.||percentage of participants||95% Confidence Interval|Number
737747|NCT00454636|Primary|Percentage of Participants With Grade 3 Hand-Foot Syndrome (HFS)||Approximately 3.25 years|Safety population: All participants who received at least one dose of study medication.||percentage of participants|||Number
737748|NCT00454649|Secondary|Percentage of Participants With Objective Response|Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.0. Confirmed response are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Baseline and thereafter every 2 cycles up to disease progression or discontinuation from study or up to 155 weeks|Population included all participants who received at least 1 dose of study medication and had at least 1 target lesion according to RECIST and a baseline assessment of disease.||Percentage of Participants|||Number
737749|NCT00454649|Secondary|Plasma Decay Half Life (t1/2) for Pemetrexed|t1/2 is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 10 minutes (end of infusion), 0.5, 1, 1.5, 2, 4, 6, 8 hr after end of infusion on Day 1 of Cycle 2 for cohort 9|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||hr||Standard Deviation|Mean
737750|NCT00454649|Secondary|Plasma Clearance (CL) for Pemetrexed|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the plasma.|0 (pre-dose), 10 minutes (end of infusion), 0.5, 1, 1.5, 2, 4, 6, 8 hr after end of infusion on Day 1 of Cycle 2 for cohort 9|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||L/hr||Standard Deviation|Mean
737751|NCT00454649|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) for Pemetrexed||0 (pre-dose), 10 minutes (end of infusion), 0.5, 1, 1.5, 2, 4, 6, 8 hr after end of infusion on Day 1 of Cycle 2 for cohort 9|Cmin was analyzed only for orally administered drugs.||ng/mL||Standard Deviation|Mean
737752|NCT00454649|Secondary|Maximum Observed Plasma Concentration (Cmax) for Pemetrexed||0 (pre-dose), 10 minutes (end of infusion), 0.5, 1, 1.5, 2, 4, 6, 8 hr after end of infusion on Day 1 of Cycle 2 for cohort 9|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||ng/mL||Standard Deviation|Mean
737753|NCT00454649|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] for Pemetrexed|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|0 (pre-dose), 10 minutes (end of infusion), 0.5, 1, 1.5, 2, 4, 6, 8 hr after end of infusion on Day 1 of Cycle 2 for cohort 9|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||ng*hr/mL||Standard Deviation|Mean
737754|NCT00454649|Secondary|Plasma Decay Half Life (t1/2) for Cisplatin|t1/2 is the time measured for the plasma concentration to decrease by one half.|Pre-dose, 0.5, 1, 1.5, 2, 3, 5, 7 hr after start of infusion on Day 1 of Cycle 2 for cohort 8 and 9|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||hr||Standard Deviation|Mean
737755|NCT00454649|Secondary|Plasma Clearance (CL) for Cisplatin|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the plasma.|Pre-dose, 0.5, 1, 1.5, 2, 3, 5, 7 hr after start of infusion on Day 1 of Cycle 2 for cohort 8 and 9|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||L/hr||Standard Deviation|Mean
737756|NCT00454649|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) for Cisplatin||Pre-dose, 0.5, 1, 1.5, 2, 3, 5, 7 hr after start of infusion on Day 1 of Cycle 2 for cohort 8 and 9|Cmin was analyzed only for orally administered drugs.||ng/mL||Standard Deviation|Mean
737757|NCT00454649|Secondary|Maximum Observed Plasma Concentration (Cmax) for Cisplatin||Pre-dose, 0.5, 1, 1.5, 2, 3, 5, 7 hr after start of infusion on Day 1 of Cycle 2 for cohort 8 and 9|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||ng/mL||Standard Deviation|Mean
737758|NCT00454649|Secondary|Area Under the Curve From Time Zero to Time 8 Hours [AUC (0-8)] for Cisplatin|AUC (0-8) = Area under the plasma concentration versus time curve from time zero (pre-dose) to time 8 hours (0-8).|Pre-dose, 0.5, 1, 1.5, 2, 3, 5, 7 hr after start of infusion on Day 1 of Cycle 2 for cohort 8 and 9|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||ng*hr/mL||Standard Deviation|Mean
737759|NCT00454649|Secondary|Plasma Decay Half Life (t1/2) for Carboplatin|t1/2 is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 5 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||hr||Standard Deviation|Mean
737760|NCT00454649|Secondary|Plasma Clearance (CL) for Carboplatin|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the plasma.|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 5 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||L/hr||Standard Deviation|Mean
737763|NCT00454649|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] for Carboplatin|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 5 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||ng*hr/mL||Standard Deviation|Mean
737764|NCT00454649|Secondary|Plasma Decay Half Life (t1/2) for Gemcitabine|t1/2 is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4 hr after start of infusion on Day 1 of Cycle 2 for cohort 8|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||hr||Standard Deviation|Mean
737765|NCT00454649|Secondary|Plasma Clearance (CL) for Gemcitabine|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the plasma.|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4 hr after start of infusion on Day 1 of Cycle 2 for cohort 8|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||L/hr||Standard Deviation|Mean
737766|NCT00454649|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) for Gemcitabine||0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4 hr after start of infusion on Day 1 of Cycle 2 for cohort 8|Cmin was analyzed only for orally administered drugs.||ng/mL||Standard Deviation|Mean
737767|NCT00454649|Secondary|Maximum Observed Plasma Concentration (Cmax) for Gemcitabine||0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4 hr after start of infusion on Day 1 of Cycle 2 for cohort 8|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||ng/mL||Standard Deviation|Mean
737768|NCT00454649|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] for Gemcitabine|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4 hr after start of infusion on Day 1 of Cycle 2 for cohort 8|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||ng*hr/mL||Standard Deviation|Mean
737769|NCT00454649|Secondary|Plasma Decay Half Life (t1/2) for Capecitabine|t1/2 is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hr post-dose on Day 1 of Cycle 2 for cohort 6 and 7|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||hr||Standard Deviation|Mean
737770|NCT00454649|Secondary|Apparent Oral Clearance (CL/F) for Capecitabine|Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes and F is the absolute oral bioavailability. Apparent oral clearance(CL/F) is obtained following oral administration.|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hr post-dose on Day 1 of Cycle 2 for cohort 6 and 7|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||Liter/hr||Standard Deviation|Mean
737771|NCT00454649|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) for Capecitabine||0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hr post-dose on Day 1 of Cycle 2 for cohort 6 and 7|Data was not summarized as majority of participants were having plasma concentrations below limit of assay quantification (BLQ).||ng/mL||Standard Deviation|Mean
737772|NCT00454649|Secondary|Maximum Observed Plasma Concentration (Cmax) for Capecitabine||0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hr post-dose on Day 1 of Cycle 2 for cohort 6 and 7|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||ng/mL||Standard Deviation|Mean
737773|NCT00454649|Secondary|Area Under the Curve From Time Zero to Time 24 Hours [AUC (0-24)] for Capecitabine|AUC (0-24) = Area under the plasma concentration versus time curve from time zero (pre-dose) to time 24 hours (0-24).|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hr post-dose on Day 1 of Cycle 2 for cohort 6 and 7|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||ng*hr/mL||Standard Deviation|Mean
737774|NCT00454649|Secondary|Plasma Decay Half Life (t1/2) for Docetaxel|t1/2 is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 5|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||hr||Standard Deviation|Mean
737775|NCT00454649|Secondary|Plasma Clearance (CL) for Docetaxel|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the plasma.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 5|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||L/hr||Standard Deviation|Mean
737777|NCT00454649|Secondary|Maximum Observed Plasma Concentration (Cmax) for Docetaxel||0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 5|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||ng/mL||Standard Deviation|Mean
737778|NCT00454649|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] for Docetaxel|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 5|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||ng*hr/mL||Standard Deviation|Mean
737779|NCT00454649|Secondary|Plasma Decay Half Life (t1/2) for Paclitaxel|t1/2 is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 1, 2, 3, 3.25, 3.5, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3; 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 4|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||hr||Standard Deviation|Mean
737780|NCT00454649|Secondary|Plasma Clearance (CL) for Paclitaxel|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the plasma.|0 (pre-dose), 1, 2, 3, 3.25, 3.5, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3; 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 4|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||L/hr||Standard Deviation|Mean
737781|NCT00454649|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) for Paclitaxel||0 (pre-dose), 1, 2, 3, 3.25, 3.5, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3; 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 4|Cmin was analyzed only for orally administered drugs.||ng/mL||Standard Deviation|Mean
737782|NCT00454649|Secondary|Maximum Observed Plasma Concentration (Cmax) for Paclitaxel||0 (pre-dose), 1, 2, 3, 3.25, 3.5, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3; 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 4|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||ng/mL||Standard Deviation|Mean
737783|NCT00454649|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] for Paclitaxel|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|0 (pre-dose), 1, 2, 3, 3.25, 3.5, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3; 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 4|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||ng*hr/mL||Standard Deviation|Mean
737784|NCT00454649|Secondary|Plasma Decay Half Life (t1/2) for Axitinib (AG-013736)|t1/2 is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 1, 2, 3, 4, 6, 8 hr post-dose on Day -1 for cohort 1, 2, 3, 5 and 8; on Day 22 of Cycle 1 for cohort 4; on Day 18 of Cycle 1 for cohorts 6 and 7; 0 (pre-dose), 1.2, 2.2, 3.2, 4.2, 6.2, 8.2 hr post-dose on Day -1 for cohort 9|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||hr||Standard Deviation|Mean
737785|NCT00454649|Secondary|Apparent Oral Clearance (CL/F) for Axitinib (AG-013736)|Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes and F is the absolute oral bioavailability. Apparent oral clearance(CL/F) is obtained following oral administration.|0 (pre-dose), 1, 2, 3, 4, 6, 8 hr post-dose on Day -1 for cohort 1, 2, 3, 5 and 8; on Day 22 of Cycle 1 for cohort 4; on Day 18 of Cycle 1 for cohorts 6 and 7; 0 (pre-dose), 1.2, 2.2, 3.2, 4.2, 6.2, 8.2 hr post-dose on Day -1 for cohort 9|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||Liter/hour (L/hr)||Standard Deviation|Mean
737786|NCT00454649|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) for Axitinib (AG-013736)||0 (pre-dose), 1, 2, 3, 4, 6, 8 hr post-dose on Day -1 for cohort 1, 2, 3, 5 and 8; on Day 22 of Cycle 1 for cohort 4; on Day 18 of Cycle 1 for cohorts 6 and 7; 0 (pre-dose), 1.2, 2.2, 3.2, 4.2, 6.2, 8.2 hr post-dose on Day -1 for cohort 9|Data was not summarized as majority of participants were having plasma concentrations below limit of assay quantification (BLQ).||ng/mL||Standard Deviation|Mean
737787|NCT00454649|Secondary|Maximum Observed Plasma Concentration (Cmax) for Axitinib (AG-013736)||0 (pre-dose), 1, 2, 3, 4, 6, 8 hr post-dose on Day -1 for cohort 1, 2, 3, 5 and 8; on Day 22 of Cycle 1 for cohort 4; on Day 18 of Cycle 1 for cohorts 6 and 7; 0 (pre-dose), 1.2, 2.2, 3.2, 4.2, 6.2, 8.2 hr post-dose on Day -1 for cohort 9|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||ng/mL||Standard Deviation|Mean
738479|NCT00457743|Secondary|Plasma Concentrations of Soluble Stem Cell Factor Receptor (sKIT)|Plasma concentrations of potential pharmacodynamic markers; Soluble Stem Cell Factor Receptor (sKIT)|Day 1, 14, 28 of Cycles 1-4|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacodynamics analysis.
n= Number of subjects with analyzable data."||pg/mL||Standard Deviation|Mean
737788|NCT00454649|Secondary|Area Under the Curve From Time Zero to Time 24 Hours [AUC (0-24)] for Axitinib (AG-013736)|AUC (0-24) = Area under the plasma concentration versus time curve from time zero (pre-dose) to time 24 hours (0-24).|0 (pre-dose), 1, 2, 3, 4, 6, 8 hr post-dose on Day -1 for cohort 1, 2, 3, 5 and 8; on Day 22 of Cycle 1 for cohort 4; on Day 18 of Cycle 1 for cohorts 6 and 7; 0 (pre-dose), 1.2, 2.2, 3.2, 4.2, 6.2, 8.2 hr post-dose on Day -1 for cohort 9|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||nanogram*hour/milliliter (ng*hr/mL)||Standard Deviation|Mean
737789|NCT00454649|Primary|Maximum Tolerated Dose (MTD) of Axitinib (AG-013736) in Combination With Chemotherapy|MTD defined as the dose level at which more than 1 out of 6 participants experienced a dose limiting toxicity (DLT). DLT included grade (Gr) 4 neutropenia or thrombocytopenia, greater than or equal to (>=) Gr 3 nonhematological toxicities or >=0.5 teaspoon/day hemoptysis or >=2 gram /24 hours proteinuria or inability to resume background chemotherapy or axitinib (AG-013736) dosing within 14 days of stopping due to treatment related toxicity.|Baseline to withdrawal from study or Day 21 of Cycle 1 [all cohorts except cohort 4 (Day 28 of Cycle 1)]|Safety analysis population included all enrolled participants who received at least 1 dose of study medication.||mg BID|||Number
737790|NCT00454779|Secondary|Overall Survival (OS) for the Second-line Treatment|Time from the first dose of panitumumab monotherapy to the date of death during the entire study|Until death, up to 57 months|Subjects who are randomized to docetaxel and cisplatin chemotherapy alone treatment for their first-line treatment and treated subsequently with at least 1 dose of second-line panitumumab monotherapy||Months||95% Confidence Interval|Median
737791|NCT00454779|Secondary|Time to Response (TTR) During the Second-line Treatment Phase|Time from the first dose of panitumumab monotherapy to the first CR or PR during second-line treatment phase (subsequently confirmed at least 4 weeks thereafter)|Every 6 weeks until disease progression or death, up to 57 months|Subjects who are randomized to docetaxel and cisplatin chemotherapy alone treatment for their first-line treatment and treated subsequently with at least 1 dose of second-line panitumumab monotherapy, with at least one uni-dimensionally measurable lesion at baseline using a modified RECIST v1.0 per investigators’ review and objective response||Weeks||Standard Deviation|Mean
737792|NCT00454779|Secondary|Duration of Response (DOR) During the Second-line Treatment Phase|Time from the first CR or PR to the first observed disease progression by a modified RECIST v1.0. Subjects not meeting the criteria for progression by the analysis data cutoff date will be censored at their last evaluable disease assessment date.|Every 6 weeks until disease progression or death, up to 57 months|Subjects who are randomized to docetaxel and cisplatin chemotherapy alone treatment for their first-line treatment and treated subsequently with at least 1 dose of second-line panitumumab monotherapy, with at least one uni-dimensionally measurable lesion at baseline using a modified RECIST v1.0 per investigators’ review and objective response||Months||95% Confidence Interval|Median
737793|NCT00454779|Secondary|Rate of Disease Control (RDC) During the Second-line Treatment Phase|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter (SLD) of target lesions from baseline; Disease Progression (PD), >=20% increase in the SLD of target lesions from nadir; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. An overall response of CR or PR must be confirmed at least 4 weeks after the criteria for response are first met. A best overall response of SD requires a visit response of SD or better no earlier than 35 days after the first dose date in second-line treatment. RCD is the percentage of subjects with a best overall response of CR, PR or SD among the analysis population.|Every 6 weeks until disease progression or death, up to 57 months|Subjects who are randomized to docetaxel and cisplatin chemotherapy alone treatment for their first-line treatment and treated subsequently with at least 1 dose of second-line panitumumab monotherapy||Percentage of Participants||95% Confidence Interval|Mean
737794|NCT00454779|Secondary|Overall Response Rate (ORR) During the Second-line Treatment Phase|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter (SLD) of target lesions from baseline; Overall Response (OR) = CR + PR. An overall response of CR or PR must be confirmed at least 4 weeks after the criteria for response are first met. ORR is the percentage of subjects with an overall response among the analysis population.|Every 6 weeks until disease progression or death, up to 57 months|Subjects who are randomized to docetaxel and cisplatin chemotherapy alone treatment for their first-line treatment and treated subsequently with at least 1 dose of second-line panitumumab monotherapy||Percentage of Participants||95% Confidence Interval|Mean
737795|NCT00454779|Secondary|Progression Free Survival (PFS) During the Second-line Treatment Phase|The time from the first dose of panitumumab monotherapy to the date of first disease progression determined by the investigators per modified RECIST v1.0, or death within 60 days after the last evaluable tumor assessment or the second-line first dose date (whichever is later) during the second-line treatment phase.|Every 6 weeks until disease progression or death, up to 57 months|Subjects who are randomized to docetaxel and cisplatin chemotherapy alone treatment for their first-line treatment and treated subsequently with at least 1 dose of second-line panitumumab monotherapy||Months||95% Confidence Interval|Median
737796|NCT00454779|Secondary|Overall Survival (OS) for the First-line Treatment|Time from the date of randomization to the date of death during the entire study|Until death, up to 67 months|All randomized participants < 70 years of age who provide informed consent and receive at least one dose of first-line treatment (chemotherapy and/or panitumumab)||Months||95% Confidence Interval|Median
737797|NCT00454779|Secondary|Time to Response (TTR) During the First-line Treatment Phase|Time from the date of randomization to the first CR or PR during first line treatment phase (subsequently confirmed at least 4 weeks thereafter)|Every 6 weeks until disease progression or death, up to 67 months|All randomized participants < 70 years of age who provide informed consent and receive at least one dose of first-line treatment (chemotherapy and/or panitumumab), with at least one uni-dimensionally measurable lesion at baseline using a modified RECIST v1.0 per investigators’ review and objective response||Weeks||Standard Deviation|Mean
737798|NCT00454779|Secondary|Duration of Response (DOR) During the First-line Treatment Phase|Calculated only for the subset of subjects who have an overall response of CR or PR while on first-line treatment phase (subsequently confirmed at least 4 weeks thereafter), and is defined as time from the first CR or PR to the first observed disease progression by a modified RECIST v1.0. Subjects not meeting the criteria for progression by the analysis data cutoff date will be censored at their last evaluable disease assessment date.|Every 6 weeks until disease progression or death, up to 67 months|All randomized participants < 70 years of age who provide informed consent and receive at least one dose of first-line treatment (chemotherapy and/or panitumumab), with at least one uni-dimensionally measurable lesion at baseline using a modified RECIST v1.0 per investigators’ review and objective response||Months||95% Confidence Interval|Median
737799|NCT00454779|Secondary|Rate of Disease Control (RDC) During the First-line Treatment Phase|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter (SLD) of target lesions from baseline; Disease Progression (PD), >=20% increase in the SLD of target lesions from nadir; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. An overall response of CR or PR must be confirmed at least 4 weeks after the criteria for response are first met. A best overall response of SD requires a visit response of SD or better no earlier than 35 days after randomization. RCD is the percentage of subjects with a best overall response of CR, PR or SD among the analysis population.|Every 6 weeks until disease progression or death, up to 67 months|all randomized subjects < 70 years of age who provide informed consent and receive at least one dose of first-line treatment (chemotherapy and/or panitumumab), with at least one uni-dimensionally measurable lesion at baseline using a modified RECIST v1.0 per investigators’ review||Percentage of Participants||95% Confidence Interval|Mean
737800|NCT00454779|Secondary|Overall Response Rate (ORR) During the First-line Treatment Phase|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter (SLD) of target lesions from baseline; Overall Response (OR) = CR + PR. An overall response of CR or PR must be confirmed at least 4 weeks after the criteria for response are first met. ORR is the percentage of subjects with an overall response among the analysis population.|Every 6 weeks until disease progression or death, up to 67 months|all randomized subjects < 70 years of age who provide informed consent and receive at least one dose of first-line treatment (chemotherapy and/or panitumumab), with at least one uni-dimensionally measurable lesion at baseline using a modified RECIST v1.0 per investigators’ review||Percentage of Participants||95% Confidence Interval|Mean
737801|NCT00454779|Primary|Progression Free Survival (PFS) During the First-line Treatment Phase|The time from the date of randomization to the date of first disease progression determined by the investigators per modified RECIST v1.0, or death within 60 days after the last evaluable tumor assessment or randomization date (whichever is later) during the first-line treatment phase.|Every 6 weeks until disease progression or death, up to 67 months|All randomized participants < 70 years of age who provide informed consent and receive at least one dose of first-line treatment (chemotherapy and/or panitumumab)||Months||95% Confidence Interval|Median
737802|NCT00454805|Secondary|Duration of Clinical Benefit|Number of days from date of clinical benefit to date of progression. Clinical benefit is defined as having a best overall tumour response of CR/PR or SD for ≥6 months.|Every 8 weeks until progression or discontinuation|||Days||Standard Deviation|Mean
737803|NCT00454805|Secondary|Clinical Benefit Rate|"Clinical Benefit is defined as the number of patients having a best overall tumour response of CR/PR or SD for ≥6 months.
The Clinical Benefit rate is defined as the number of responders divided by the number in the Intention-to-treat (ITT) analysis set: responder=overall best response of complete response (CR)/partial response (PR) or stable disease (SD) for at least 6 months (calculated from the date of randomisation) as defined by RECIST criteria at any point prior to the data cut-off."|Every 8 weeks until progression or discontinuation|||Ratio|||Number
737804|NCT00454805|Secondary|Duration of Response|Number of days from date of response (complete/partial based on RECIST) to date of progression|Every 8 weeks until progression or discontinuation|||Days||Full Range|Median
737805|NCT00454805|Secondary|Objective Response Rate|"Best objective tumour response (based on Response Evaluation Criteria in Solid Tumours (RECIST)) during the study for patients with measurable disease. Best objective tumour response defined as:
Complete Response (CR) Disappearance of all target lesions Partial response (PR) At least a 30% decrease in the sum of longest diameters (LDs) of target lesions, taking as reference the baseline sum of LDs.
Progression (PD) At least a 20% increase in the sum of LDs of target lesions, taking as reference the smallest sum of LDs since treatment started (including the baseline sum of LDs) and at least 5 mm increase.
Stable disease (SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD"|RECIST performed at screening and every 8 weeks through to progression or discontinuation whichever is earliest.|||Participants|||Number
737806|NCT00454805|Primary|Progression Free Survival|Number of months from randomisation until progressive disease based on RECIST (progression of target lesions, clear progression of existing non-target lesions or the appearance of one or more new lesions) or death in the absence of progression.|RECIST performed at screening and every 8 weeks through to progression or discontinuation whichever is earliest.|||Days||95% Confidence Interval|Median
737807|NCT00454818|Other Pre-specified|Phase 1 and Phase 2: All Subject Deaths Through 36 Months|"All subject deaths that occurred during the 12-month study or the 24-month follow-up in subjects enrolled in either the Phase 1 or Phase 2 trial. Events occurring after early termination from the trial are listed as occurring during long-term follow-up, but may have been within 12 months. Specifically, two cardiovascular (CV) deaths in placebo subjects occurred following early study termination, but within 12 months of study initiation. These deaths are therefore included under Deaths within 12 months but also listed as Cardiovascular deaths in long-term follow-up. Accordingly, the number of Cardiovascular deaths in long-term follow-up for the placebo group is greater than the number of Deaths after 12 months, as 2 of the deaths occurred within 12 months but after early termination."|36 months|"Includes all participants enrolled in the Phase 1 or Phase 2 trial. Events occurring after early termination are listed under long-term follow-up. The number of CV deaths in long-term follow-up for the placebo group is greater than the number of Deaths after 12 months, as 2 deaths occurred within 12 months but after early termination."||participants|||Number
737808|NCT00454818|Other Pre-specified|Phase 2: Change in Absolute Left Ventricular End Systolic Volume (LVESV) From Baseline to Month 12|Contrast echocardiography was used to determine LVESV. Decreases in LVESV are associated with reduced mortality. Changes from baseline with positive values indicate a worsening in heart function and changes from baseline with negative values indicate an improvement in symptoms.|Baseline to 12 months|This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.||mL||Standard Deviation|Mean
737809|NCT00454818|Primary|Phase 2: Change in Absolute Left Ventricular End Systolic Volume (LVESV) Frm Baseline to Month 6|Contrast echocardiography was used to determine LVESV. Decreases in LVESV are associated with reduced mortality. Changes from baseline with positive values indicate a worsening in heart function and changes from baseline with negative values indicate an improvement in symptoms.|Baseline to 6 months|This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.||mL||Standard Deviation|Mean
737810|NCT00454818|Primary|Phase 2: Change in Percentage of Blood Ejected From the Left Ventricle (LV) (i.e., Left Ventricular Ejection Fraction [LVEF]) From Baseline to Month 6|Contrast echocardiography was used to determine LVEF. Increases in LVEF are associated with reduced mortality. Changes from baseline with positive values indicate an improvement in heart function and changes from baseline with negative values indicate a worsening of heart function.|Baseline to 6 months|This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.||Percentage of blood ejected from the LV||Standard Deviation|Mean
737811|NCT00454818|Other Pre-specified|Phase 2: Change in Percentage of Blood Ejected From the Left Ventricle (LV) (i.e., Left Ventricular Ejection Fraction [LVEF]) From Baseline to Month 12|Contrast echocardiography was used to determine LVEF. Increases in LVEF are associated with reduced mortality. Changes from baseline with positive values indicate an improvement in heart function and changes from baseline with negative values indicate a worsening of heart function.|Baseline to 12 months|This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.||Percentage of blood ejected from the LV||Standard Deviation|Mean
737812|NCT00454818|Post-Hoc|Phase 2: Selected Clinical Outcomes During 12-month Study Period|Incidences of key clinical endpoints as adjudicated by the blinded Clinical Endpoint Committee.|12 months|This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.||percentage of participants|||Number
737813|NCT00454818|Other Pre-specified|Phase 2: Change in Absolute Levels of N-terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) From Baseline to Month 12|NT-proBNP is a biomarker for heart failure. Increased levels of this biomarker are associated with increased mortality and cardiovascular hospitalization in patients with heart failure.|Baseline to 12 months|This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial. NT-proBNP data were not available for 1 patient in the MYDICAR high dose group.||pg/mL||Standard Deviation|Mean
737814|NCT00454818|Other Pre-specified|Phase 2: Change in Peak Maximum Oxygen Consumption (VO2) From Baseline to Month 12|Peak VO2 is a measure of maximal oxygen consumption during cardiopulmonary exercise testing; this study used the modified Naughton treadmill protocol. Higher values indicate a better functional status. Changes from baseline with negative values indicate a worsening in function and changes from baseline with positive values indicate an improvement in function.|Baseline to 12 months|This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial. Peak VO2 data were not available for one patient in the placebo group.||mL/kg per minute||Standard Deviation|Mean
737815|NCT00454818|Other Pre-specified|Phase 2: Change in 6-minute Walk Test (6MWT) From Baseline to Month 12|The 6MWT measures the distance walked in meters during a 6-minute test. Higher values indicate a better functional status. Changes from baseline with negative values indicate a worsening in function and changes from baseline with positive values indicate an improvement in function.|Baseline to 12 months|This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.||meters||Standard Deviation|Mean
737816|NCT00454818|Other Pre-specified|Phase 2: Change in Symptomatic Efficacy Domains From Baseline to Month 12: New York Heart Association (NYHA) Class and Minnesota Living With Heart Failure Questionnaire (MLWHFQ) Score|"NYHA classification is a symptomatic assessment in which the investigator evaluates subjects on a scale ranging from Class I (subjects with no limitation of activities, no symptoms from ordinary activities) to Class IV (subjects who should be at complete rest, confined to bed or chair; any physical activity brings on discomfort and symptoms occur at rest).
The MLWHFQ is a patient-reported quality of life (QoL) measure in which patients assess the impact of their heart condition on activities in the past month using a Likert scale ranging from 0 (no effect) to 5 (very much effect). Higher scores thus indicate a lower QoL. The maximum (worst) score is 105 and the minimum (best) score is 0.
For both measures, changes from baseline with positive values indicate a worsening in symptoms and changes from baseline with negative values indicate an improvement in symptoms."|Baseline to 12 months|This analysis was performed on the intention to treat population, which included all patients randomized to treatment.||units on a scale||Standard Deviation|Mean
737817|NCT00454818|Other Pre-specified|Phase 2: Length of Cardiovascular-related Hospitalizations at 12 Months|Mean number of days in the hospital for cardiovascular-related complications. All hospitalizations were evaluated and classified by the blinded Clinical Endpoints Committee.|12 months|This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.||days||Standard Deviation|Mean
737818|NCT00454818|Primary|Phase 2: Change in Absolute Levels of N-terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) From Baseline to Month 6|NT-proBNP is a biomarker for heart failure. Increased levels of this biomarker are associated with increased mortality and cardiovascular hospitalization in patients with heart failure.|Baseline to 6 months|This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial. NT-proBNP data were not available for 1 patient in the MYDICAR high dose group.||pg/mL||Standard Deviation|Mean
737819|NCT00454818|Primary|Phase 2: Change in Peak Maximum Oxygen Consumption (VO2) From Baseline to Month 6|Peak VO2 is a measure of maximal oxygen consumption during cardiopulmonary exercise testing; this study used the modified Naughton treadmill protocol. Higher values indicate a better functional status. Changes from baseline with negative values indicate a worsening in function and changes from baseline with positive values indicate an improvement in function.|Baseline to 6 months|This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.||mL/kg per minute||Standard Deviation|Mean
737820|NCT00454818|Primary|Phase 2: Change in 6-minute Walk Test (6MWT) From Baseline to Month 6|The 6MWT measures the distance walked in meters during a 6-minute test. Higher values indicate a better functional status. Changes from baseline with negative values indicate a worsening in function and changes from baseline with positive values indicate an improvement in function.|Baseline to 6 months|This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.||meters||Standard Deviation|Mean
737821|NCT00454818|Primary|Phase 2: Change in Symptomatic Efficacy Domains From Baseline to Month 6: New York Heart Association (NYHA) Class and Minnesota Living With Heart Failure Questionnaire (MLWHFQ) Score|"NYHA classification is a symptomatic assessment in which the investigator evaluates subjects on a scale ranging from Class I (subjects with no limitation of activities, no symptoms from ordinary activities) to Class IV (subjects who should be at complete rest, confined to bed or chair; any physical activity brings on discomfort and symptoms occur at rest).
The MLWHFQ is a patient-reported quality of life (QoL) measure in which patients assess the impact of their heart condition on activities in the past month using a Likert scale ranging from 0 (no effect) to 5 (very much effect). Higher scores thus indicate a lower QoL. The maximum (worst) score is 105 and the minimum (best) score is 0.
For both measures, changes from baseline with positive values indicate a worsening in symptoms and changes from baseline with negative values indicate an improvement in symptoms."|Baseline to 6 months|This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.||units on a scale||Standard Deviation|Mean
737822|NCT00454818|Primary|Phase 2: Length of Cardiovascular-related Hospitalizations at 6 Months|Mean number of days in the hospital for cardiovascular-related complications. All hospitalizations were evaluated and classified by the blinded Clinical Endpoints Committee.|6 months|This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.||days||Standard Deviation|Mean
737823|NCT00454818|Primary|Phase 2: Incidence of Treatment-emergent Adverse Events (TEAE) at 12 Months|"Includes all adverse events that occurred from the time of first infusion of the investigational product or placebo to the 12-month visit. The category of TEAEs related to the investigational product (IP) includes TEAEs considered by the investigator to be possibly, probably, or definitely related to the IP."|12 months|This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.||percentage of participants|||Number
737824|NCT00454857|Secondary|Number of Participants Requiring Splenectomy|The number of participants who required a splenectomy during the 12-month prospective phase of the study.|12 months|All enrolled participants who completed at least 1 observational study visit during the prospective phase.||Participants|||Number
737825|NCT00454857|Secondary|Duration of Exposure to ITP Medication|Duration of exposure to each ITP medication measured from enrollment until the end of the 12-month data collection phase.|12 months (prospective data collection phase)|All enrolled participants who completed at least 1 observational study visit during the prospective phase. N=number of participants using each medication.||Months||Standard Deviation|Mean
737826|NCT00454857|Secondary|Number of Participants Receiving Drug Therapies for Treatment of ITP During the Prospective Phase|The number of participants who received drug therapies for the treatment of ITP during the prospective phase of the study. Use of multiple medications by the same participants is possible.|12 months (prospective data collection phase)|All enrolled participants who completed at least 1 observational study visit during the prospective phase.||Participants|||Number
737827|NCT00454857|Secondary|Change From Baseline to Month 12 in Treatment Satisfaction|Participant satisfaction with treatment was measured using the Treatment Satisfaction Questionnaire for Medication (TSQM), an 11-item questionnaire providing scores on four scales – side effects, effectiveness, convenience and global satisfaction. TSQM Scale scores range from 0 to 100 with higher scores indicating more satisfaction with treatment.|Baseline to Month 12 during prospective data collection phase|The Patient Reported Outcome (PRO) Analysis Set includes all participants who completed at least one questionnaire during the prospective observation period.||Units on a scale||Standard Deviation|Mean
737828|NCT00454857|Secondary|Change From Baseline to Month 12 in Health-related Quality of Life Assessed by EuroQol Visual Analog Scale (EQ-5D VAS)|The EQ VAS records the respondent’s self-rated health on a vertical, visual analogue scale where the endpoints are labelled ‘Best imaginable health state’ (score = 100) and ‘Worst imaginable health state’ (score = 0).|Baseline to Month 12 during prospective data collection phase|The Patient Reported Outcome (PRO) Analysis Set includes all subjects who completed at least one questionnaire during the prospective observation period.||Units on a scale||Standard Deviation|Mean
737829|NCT00454857|Secondary|Change From Baseline to Month 12 in Quality of Life Measured by the ITP-Patient Assessment Questionnaire (PAQ)|The Immune Thrombocytopenic Purpura Patient Assessment Questionnaire (ITP-PAQ) was developed to assess disease-specific quality of life (QoL) in adults with ITP. It is a 44-item questionnaire that includes scales for physical health (symptoms, fatigue/sleep, bother, and activity), emotional health (psychological and fear), overall QoL, social activity, women's reproductive health, and work. Scores for each scale range from 0 (worst) to 100 (best).|Baseline to month 12 during prospective data collection phase|The Patient Reported Outcome (PRO) Analysis Set includes all participants who completed at least one questionnaire during the prospective observation period.||Units on a scale||Standard Deviation|Mean
737830|NCT00454857|Primary|The Number of Participants Utilizing ITP Therapies: Treatments With Unknown Starting Date.|The number of participants who received ITP therapies for treatments with unknown starting date during either the retrospective or prospective phases of the study.|Includes the retrospective chart review (from the date of enrollment retrospectively to the date of diagnosis or the previous 36 months, whichever was less) and the prospective portion of the study (enrollment through Month 12).|All enrolled participants||Participants|||Number
737831|NCT00454857|Primary|The Number of Participants Utilizing ITP Therapies for Seventh or Greater-line Treatment.|The number participants who received ITP therapies as seventh or greater-line treatment during either the retrospective or prospective phases of the study.|Includes the retrospective chart review (from the date of enrollment retrospectively to the date of diagnosis or the previous 36 months, whichever was less) and the prospective portion of the study (enrollment through Month 12).|All enrolled participants||Participants|||Number
737832|NCT00454857|Primary|The Number of Participants Utilizing ITP Therapies for Sixth-line Treatment.|Assessed the number of participants who received ITP therapies for sixth-line treatment during either the retrospective or prospective phases of the study.|Includes the retrospective chart review (from the date of enrollment retrospectively to the date of diagnosis or the previous 36 months, whichever was less) and the prospective portion of the study (enrollment through Month 12).|All enrolled participants||Participants|||Number
737833|NCT00454857|Primary|The Number of Participants Utilizing ITP Therapies for Fifth-line Treatment|The number of participants who received ITP therapies for fifth-line treatment during either the retrospective or prospective phases of the study.|Includes the retrospective chart review (from the date of enrollment retrospectively to the date of diagnosis or the previous 36 months, whichever was less) and the prospective portion of the study (enrollment through Month 12).|All enrolled participants||Participants|||Number
737834|NCT00454857|Primary|The Number of Participants Utilizing ITP Therapies for Fourth-line Treatment.|The number of participants who received ITP therapies for fourth-line treatment during either the retrospective or prospective phases of the study.|Includes the retrospective chart review (from the date of enrollment retrospectively to the date of diagnosis or the previous 36 months, whichever was less) and the prospective portion of the study (enrollment through Month 12).|All enrolled participants||Participants|||Number
737835|NCT00454857|Primary|The Number of Participants Utilizing ITP Therapies for Third-line Treatment.|The number of participants who received ITP therapies for third-line treatment during either the retrospective or prospective phases of the study.|Includes the retrospective chart review (from the date of enrollment retrospectively to the date of diagnosis or the previous 36 months, whichever was less) and the prospective portion of the study (enrollment through Month 12).|All enrolled participants||Participants|||Number
737836|NCT00454857|Primary|The Number of Participants Utilizing ITP Therapies for Second-line Treatment.|The number of participants who received ITP therapies for second-line treatment during either the retrospective or prospective phases of the study.|Includes the retrospective chart review (from the date of enrollment retrospectively to the date of diagnosis or the previous 36 months, whichever was less) and the prospective portion of the study (enrollment through Month 12).|All enrolled participants||Participants|||Number
737837|NCT00454857|Primary|Number of Participants Utilizing Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Therapies for First-line Treatment|The number of participants who received ITP therapies for first-line treatment during either the retrospective or prospective phases of the study.|Includes the retrospective chart review (from the date of enrollment retrospectively to the date of diagnosis or the previous 36 months, whichever was less) and the prospective portion of the study (enrollment through Month 12).|All enrolled participants||Participants|||Number
737838|NCT00454909|Secondary|Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits||From Day 0 to Month 6|The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.||Participants|||Count of Participants
737839|NCT00454909|Secondary|Number of Subjects Reporting Rash|Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae.|From Day 0 to Month 6|The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.||Participants|||Count of Participants
737840|NCT00454909|Secondary|Number of Subjects With New Onset Chronic Illness(es) (NOCI)|NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.|From Day 0 to Month 6|The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.||Participants|||Count of Participants
737841|NCT00454909|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Day 0 to Month 6|The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.||Participants|||Count of Participants
737842|NCT00454909|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Days 0–30) follow-up period after vaccination|The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.||Participants|||Count of Participants
737843|NCT00454909|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, fever [defined as orally temperature equal to or above 37.5 degrees Celsius (°C)], gastrointestinal symptoms and headache. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 4-day (Days 0-3) and the 8-day (Days 0-7) post-vaccination period|The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.||Participants|||Count of Participants
737844|NCT00454909|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.|During the 4-day (Days 0-3) and the 8-day (Days 0-7) post-vaccination period|The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.||Participants|||Count of Participants
737845|NCT00454909|Secondary|hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers|Antibody titers are presented as geometric mean titers (GMTs).|At Day 0 (PRE) and Month 1|The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. The interval between Visit 1 (Month 0) and Visit 2 (Month 1) for inclusion in this cohort was defined as 21 to 48 days||Titers||95% Confidence Interval|Geometric Mean
737846|NCT00454909|Secondary|Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value|The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.|At Day 0 (PRE) and Month 1|The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. The interval between Visit 1 (Month 0) and Visit 2 (Month 1) for inclusion in this cohort was defined as 21 to 48 days.||Participants|||Count of Participants
737847|NCT00454909|Primary|Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value|The cut-off value for the hSBA titers was greater than or equal to (≥) 1:8.|At Month 1|The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. The interval between Visit 1 (Month 0) and Visit 2 (Month 1) for inclusion in this cohort was defined as 21 to 48 days.||Participants|||Count of Participants
737848|NCT00454909|Primary|Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (hSBA-MenA, hSBA-MenC , hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value|The cut-off value for the hSBA titers was greater than or equal to (≥) 1:8.|At Day 0 (PRE)|The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. The interval between Visit 1 (Month 0) and Visit 2 (Month 1) for inclusion in this cohort was defined as 21 to 48 days.||Participants|||Count of Participants
737849|NCT00454987|Primary|Number of Subjects With SAE(s)|A SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization, as per the medical or scientific judgement of the physician. Any = Occurrence of a SAE, regardless of relationship to vaccination.|Within (31-Days) at Year 2|The Total Cohort Year 2 included all vaccinated subjects in the booster study 104056 who came back for the Year 2 follow-up and also all subjects of NoBoost Group who were enrolled and vaccinated at Visit 2 (i.e. 40-43 months of age).||Subjects|||Number
737850|NCT00454987|Primary|Number of Subjects With SAE(s)|A SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization, as per the medical or scientific judgement of the physician. Any = Occurrence of a SAE, regardless of relationship to vaccination.|Up to Month 48 (Booster vaccination)|The Booster Total Vaccinated Cohort included all subjects who received the booster dose during study Hib-MenC-TT- 013 BST:012 (104056)||Subjects|||Number
737851|NCT00454987|Primary|Number of Subjects With SAE(s)|A SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization, as per the medical or scientific judgement of the physician. Any = Occurrence of a SAE, regardless of relationship to vaccination.|Up to Month 24 (Booster vaccination)|The Booster Total Vaccinated Cohort included all subjects who received the booster dose during study Hib-MenC-TT- 013 BST:012 (104056)||Subjects|||Number
737852|NCT00454987|Primary|Number of Subjects With Serious Adverse Events (SAEs)|A SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization, as per the medical or scientific judgement of the physician. Any = Occurrence of a SAE, regardless of relationship to vaccination.|Up to Month 12 (Booster vaccination)|The Booster Total Vaccinated Cohort included all subjects who received the booster dose during study Hib-MenC-TT- 013 BST:012 (104056)||Subjects|||Number
737853|NCT00454987|Primary|Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies|Antibody concentrations for anti-pertussis toxoid, anti-filamentous haemagglutin and anti-pertactin were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in EL.U/mL.|At Year 4|The ATP cohort for persistence Year 4 included all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056, who had assay results available for at least one tested antigen at Year 4.||EL.U/mL||95% Confidence Interval|Geometric Mean
737854|NCT00454987|Primary|Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations ≥ 5.0 EL.U/mL|The anti-pertussis toxoid, anti-filamentous haemagglutin, anti-pertactin activity was determined using an Enzyme-linked Immunosorbent Assay (ELISA).|At Year 4|The ATP cohort for persistence Year 4 included all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056, who had assay results available for at least one tested antigen at Year 4.||Subjects|||Number
737855|NCT00454987|Primary|Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies|Antibody concentrations for anti-pertussis toxoid, anti-filamentous haemagglutin and anti-pertactin C were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in EL.U/mL.|At Year 2|The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056 or a 3-dose a Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.||Subjects||95% Confidence Interval|Number
737856|NCT00454987|Primary|Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Equal to or Above 5.0 ELISA Units Per Milliliter (EL.U/mL)|The anti-pertussis toxoid, anti-filamentous haemagglutin, anti-pertactin activity was determined using an Enzyme-linked Immunosorbent Assay (ELISA).|At Year 2|The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056 or a 3-dose a Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.||Subjects|||Number
737857|NCT00454987|Primary|Concentration of Anti-PSC Antibodies|Antibody concentrations for anti-polysaccharide C were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in µg/mL. Concentrations bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|At Year 4|The ATP cohort for persistence Year 4 included all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056, who had assay results available for at least one tested antigen at Year 4.||µg/mL||95% Confidence Interval|Geometric Mean
737858|NCT00454987|Primary|Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL|The anti-polysaccharide C activity was determined using an Enzyme-linked Immunosorbent Assay (ELISA).|At Year 4|The ATP cohort for persistence Year 4 included all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056, who had assay results available for at least one tested antigen at Year 4.||Subjects|||Number
737859|NCT00454987|Primary|Concentration of Anti-PSC Antibodies|Antibody concentrations for anti-polysaccharide C were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in µg/mL. Concentrations bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|At Year 2|The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056 or a 3-dose a Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.||µg/mL||95% Confidence Interval|Geometric Mean
737860|NCT00454987|Primary|Concentration of Anti-PSC Antibodies|Antibody concentrations for anti-polysaccharide C were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in µg/mL. Concentrations bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|At Year 2|The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056 or a 3-dose a Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.||µg/mL||95% Confidence Interval|Geometric Mean
737861|NCT00454987|Primary|Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL|The anti-polysaccharide C activity was determined using an Enzyme-linked Immunosorbent Assay (ELISA).|At Year 2|The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056 or a 3-dose a Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.||Subjetcs|||Number
737862|NCT00454987|Primary|Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL|The anti-polysaccharide C activity was determined using an Enzyme-linked Immunosorbent Assay (ELISA).|At Year 2|The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056 or a 3-dose a Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.||Subjects|||Number
737863|NCT00454987|Primary|Concentration of Anti-PSC Antibodies|Antibody concentrations for anti-polysaccharide C were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in µg/mL. Concentrations bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|At Year 1|The ATP cohort for persistence Year 1 included all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056, who had available assay results for at least one tested antigen at Year 1.||µg/mL||95% Confidence Interval|Geometric Mean
737864|NCT00454987|Primary|Number of Subjects With Anti-serogroup C Polysaccharide (Anti-PSC) Antibody Concentrations Equal to or Above 0.3 Micrograms Per Milliliter(µg/mL) and Equal to or Above 2 Micrograms Per Milliliter (µg/mL)|The anti-polysaccharide C activity was determined using an Enzyme-linked Immunosorbent Assay (ELISA).|At Year 1|The ATP cohort for persistence Year 1 included all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056, who had available assay results for at least one tested antigen at Year 1.||Subjects|||Number
737865|NCT00454987|Primary|Concentration of Anti-PRP Antibodies|Antibody concentrations for anti-polyribosylribitol phosphate were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in µg/mL. Concentrations bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|At Year 4|The ATP cohort for persistence Year 4 included all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056, who had assay results available for at least one tested antigen at Year 4.||µg/mL||95% Confidence Interval|Geometric Mean
737866|NCT00454987|Primary|Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL|The anti-polyribosylribitol phosphate was determined using an Enzyme-linked Immunosorbent Assay (ELISA).|At Year 4|The ATP cohort for persistence Year 4 included all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056, who had assay results available for at least one tested antigen at Year 4.||Subjects|||Number
737867|NCT00454987|Primary|Concentration of Anti-PRP Antibodies|Antibody concentrations for anti-polyribosylribitol phosphate were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in µg/mL. Concentrations bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|At Year 2|The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056 or a 3-dose a Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.||µg/mL||95% Confidence Interval|Geometric Mean
738580|NCT00450580|Secondary|Number of Participants With HIV-1 RNA <400 Copies/mL (Primary Endpoint) at Week 48 Categorised by Baseline CD4+ Count, TLOVR Analysis|The number of participants with HIV-1 RNA <400 copies/mL at week 48 was determined (by analysis of blood draw) and categorised by baseline CD4+ count.|Week 48|ITT-E Population||Participants|||Number
737868|NCT00454987|Primary|Concentration of Anti-PRP Antibodies|Antibody concentrations for anti-polyribosylribitol phosphate were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in µg/mL. Concentrations bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|At Year 2|The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056 or a 3-dose a Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.||µg/mL||95% Confidence Interval|Geometric Mean
737869|NCT00454987|Primary|Number of Subjects With Anti-PRP Antibodies ≥0.15 µg/mL and ≥1 µg/mL|The anti-polyribosylribitol phosphate was determined using an Enzyme-linked Immunosorbent Assay (ELISA).|At Year 2|The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056 or a 3-dose a Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.||Subjects|||Number
737870|NCT00454987|Primary|Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL|The anti-polyribosylribitol phosphate was determined using an Enzyme-linked Immunosorbent Assay (ELISA).|At Year 2|The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056 or a 3-dose a Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.||Subjects|||Number
737871|NCT00454987|Primary|Concentration of Anti-PRP Antibodies|Antibody concentrations for anti-polyribosylribitol phosphate were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in µg/mL. Concentrations bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|At Year 1|The ATP cohort for persistence Year 1 included all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056, who had available assay results for at least one tested antigen at Year 1.||µg/mL||95% Confidence Interval|Geometric Mean
737872|NCT00454987|Primary|Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibodies Equal to or Above 0.15 Micrograms Per Milliliter (µg/mL) and Equal to or Above 1 Micrograms Per Milliliter (µg/mL)|The anti-polyribosylribitol phosphate was determined using an Enzyme-linked Immunosorbent Assay (ELISA).|At Year 1|The ATP cohort for persistence Year 1 included all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056, who had available assay results for at least one tested antigen at Year 1.||Subjects|||Number
737873|NCT00454987|Primary|rSBA-MenC Antibody Titers|Antibody concentrations for anti-serogroup C serum bactericidal assay using baby rabbit complement were expressed as geometric mean titers (GMT) with 95% confidence intervals (CI). Titers bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMT calculation.|At Year 4|The ATP cohort for persistence Year 4 included all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056, who had assay results available for at least one tested antigen at Year 4.||Titre||95% Confidence Interval|Geometric Mean
737874|NCT00454987|Primary|Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128|The anti-meningococcal serogroup C activity was determined using a serum bactericidal test. The cut-off of the assay is a dilution of 1:128, resulting in 50% inhibition.|At Year 4|The ATP cohort for persistence Year 4 included all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056, who had assay results available for at least one tested antigen at Year 4.||Subjects|||Number
737875|NCT00454987|Primary|Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:8|The anti-meningococcal serogroup C activity was determined using a serum bactericidal test. The cut-off of the assay is a dilution of 1:8, resulting in 50% inhibition.|At Year 4|The ATP cohort for persistence Year 4 included all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056, who had assay results available for at least one tested antigen at Year 4.||Subjects|||Number
737876|NCT00454987|Primary|rSBA-MenC Antibody Titers|Antibody concentrations for anti-serogroup C serum bactericidal assay using baby rabbit complement were expressed as geometric mean titers (GMT) with 95% confidence intervals (CI). Titers bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMT calculation.|At Year 2|The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056 or a 3-dose a Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.||Titre||95% Confidence Interval|Geometric Mean
737877|NCT00454987|Primary|rSBA-MenC Antibody Titers|Antibody concentrations for anti-serogroup C serum bactericidal assay using baby rabbit complement were expressed as geometric mean titers (GMT) with 95% confidence intervals (CI). Titers bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMT calculation.|At Year 2|The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056 or a 3-dose a Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.||Titre||95% Confidence Interval|Geometric Mean
737878|NCT00454987|Primary|Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128|The anti-meningococcal serogroup C activity was determined using a serum bactericidal test. The cut-off of the assay is a dilution of 1:128, resulting in 50% inhibition.|At Year 2|The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056 or a 3-dose a Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.||Subjects|||Number
737879|NCT00454987|Primary|Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128|The anti-meningococcal serogroup C activity was determined using a serum bactericidal test. The cut-off of the assay is a dilution of 1:128, resulting in 50% inhibition.|At Year 2|The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056 or a 3-dose a Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.||Subjects|||Number
737949|NCT00444600|Secondary|Number of Laser Treatments Received Prior to the 1 Year Visit|One eye in the sham+prompt laser group did not receive laser until post 1-year due to an adverse event unrelated to study treatment. One eye in the triamcinolone+prompt laser did not receive laser until after 1-year due to missing 2 consecutive visits at the time of required laser treatment.|1 Year|Number who completed the 1-year visit.||Eyes|Participants||Number
737880|NCT00454987|Primary|Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:8|The anti-meningococcal serogroup C activity was determined using a serum bactericidal test. The cut-off of the assay is a dilution of 1:8, resulting in 50% inhibition.|At Year 2|The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056 or a 3-dose a Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.||Subjects|||Number
737881|NCT00454987|Primary|Number of Subjects With rSBA-MenC Antibody Titers ≥1:8|The anti-meningococcal serogroup C activity was determined using a serum bactericidal test. The cut-off of the assay is a dilution of 1:8, resulting in 50% inhibition.|At Year 2|The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056 or a 3-dose a Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.||Subjects|||Number
737882|NCT00454987|Primary|rSBA-MenC Antibody Titers|Antibody concentrations for the serogroup C serum bactericidal assay using baby rabbit complement were expressed as geometric mean titers (GMT) with 95% confidence intervals (CI). Titers bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMT calculation.|At Year 1|The ATP cohort for persistence Year 1 included all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056, who had available assay results for at least one tested antigen at Year 1.||Titre||95% Confidence Interval|Geometric Mean
737883|NCT00454987|Primary|Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128|The anti-meningococcal serogroup C activity was determined using a serum bactericidal test. The cut-off of the assay is a dilution of 1:128, resulting in 50% inhibition.|At Year 1|The ATP cohort for persistence Year 1 included all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056, who had available assay results for at least one tested antigen at Year 1.||Subjects|||Number
737884|NCT00454987|Primary|Number of Subjects With Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA-MenC) Antibody Titers Equal to or Above 1:8|The anti-meningococcal serogroup C activity was determined using a serum bactericidal test. The cut-off of the assay is a dilution of 1:8, resulting in 50% inhibition.|At Year 1|The ATP cohort for persistence Year 1 included all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056, who had available assay results for at least one tested antigen at Year 1.||Subjects|||Number
737950|NCT00444600|Primary|Change in Visual Acuity From Baseline to 1 Year Grouped by Diffuse vs. Focal Edema as Characterized by the Investigator|Change in best correct visual acuity letter score from baseline to one year as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale 97, worst 0.|from baseline to 1 Year|||Letters|Participants|Standard Deviation|Mean
737907|NCT00444457|Other Pre-specified|Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age)|Systemic events (any fever ≥ 38 degrees C, decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 7 days after dose (4 months of age)|Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting any systemic events; (n)=number of participants reporting yes for at least 1 day or no for all days for the three 13vPnC groups and 7vPnC, respectively.||percentage of participants|||Number
737905|NCT00444457|Other Pre-specified|Percentage of Participants Reporting Systemic Events in the Combined 13vPnC Group and 7vPnC Group: Toddler Dose (12 Months of Age)|Systemic events (any fever ≥ 38 degrees C, decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 7 days after dose (12 months of age)|Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting any systemic events; (n)=number of participants reporting yes for at least 1 day or no for all days for the combined 13vPnC group and 7vPnC, respectively.||percentage of participants|||Number
737906|NCT00444457|Other Pre-specified|Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age)|Systemic events (any fever ≥ 38 degrees C, decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 7 days after dose (6 months of age)|Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting any systemic events; (n)=number of participants reporting yes for at least 1 day or no for all days for the three 13vPnC groups and 7vPnC, respectively.||percentage of participants|||Number
737945|NCT00444600|Secondary|Percentage of Eyes Receiving Laser at the 48 Week Visit (%)||1 Year|||Eyes|Participants||Number
737908|NCT00444457|Other Pre-specified|Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age)|Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 7 days after dose (2 months of age)|Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting any systemic events; (n)=number of participants reporting yes for at least 1 day or no for all days for the three 13vPnC groups and 7vPnC, respectively.||percentage of participants|||Number
737909|NCT00444457|Other Pre-specified|Percentage of Participants Reporting Local Reactions in the Combined 13vPnC Group and 7vPnC Group: Toddler Dose (12 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 7 days after dose (12 months of age)|Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting any local reactions; (n)=number of participants reporting yes for at least 1 day or no for all days for the combined 13vPnC group and 7vPnC, respectively.||percentage of participants|||Number
737910|NCT00444457|Other Pre-specified|Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 7 days after dose (6 months of age)|Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting any local reactions; (n)=number of participants reporting yes for at least 1 day or no for all days for the three 13vPnC groups and 7vPnC, respectively.||percentage of participants|||Number
737911|NCT00444457|Other Pre-specified|Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 7 days after dose (4 months of age)|Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting any local reactions; (n)=number of participants reporting yes for at least 1 day or no for all days for the three 13vPnC groups and 7vPnC, respectively.||percentage of participants|||Number
737912|NCT00444457|Other Pre-specified|Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 7 days after dose (2 months of age)|Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting any local reactions; (n)=number of participants reporting yes for at least 1 day or no for all days for the three 13vPnC groups and 7vPnC, respectively.||percentage of participants|||Number
737913|NCT00444457|Secondary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose|Antibody geometric mean concentration (GMC) as measured by mcg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.|1 month after the toddler dose (13 months of age)|Evaluable immunogenicity population; (n)=number of subjects with a determinate IgG antibody concentration to the given serotype for the three 13vPnC lots, respectively.||GMC mcg/mL||95% Confidence Interval|Geometric Mean
737914|NCT00444457|Secondary|Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose|Percentage of participants achieving predefined antibody threshold ≥1.00 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.|1 month after the toddler dose (13 months of age)|Evaluable immunogenicity population; (n)=number of subjects with a determinate IgG antibody concentration to the given serotype for the three 13vPnC lots, respectively.||observed percentage of participants||95% Confidence Interval|Number
737915|NCT00444457|Secondary|Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Combined 13vPnC Group 1 Month After the Infant Series|Percentage of participants achieving predefined antibody threshold ≥1.00 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.|1 month after the infant series (7 months of age)|Evaluable immunogenicity population; (n)=number of subjects with a determinate IgG antibody concentration to the given serotype for the combined 13vPnC lot.||observed percentage of participants||95% Confidence Interval|Number
737946|NCT00444600|Other Pre-specified|Change From Severe Non-proliferative Diabetic Retinopathy or Worse From Baseline to 1-year|Criteria are based on the ETDRS fundus photographic risk factors for the progression of diabetic retinopathy. ETDRS report no. 12. Ophthalmology 1991; 98:823-833, ETDRS Severity Scale = Diabetic retinopathy absent, minimal non-proliferative diabetic retinopathy (PDR), mild to moderately severe non-PDR, severe non-PDR, scars of full pr partial panretinal photocoagulation present PDR absent, mild to moderate PDR, high risk PDR, cannot grade, missing.|from baseline to 1 Year|||Eyes|Participants||Number
737916|NCT00444457|Secondary|Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose|Percentage of participants achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.|1 month after the toddler dose (13 months of age)|Evaluable immunogenicity population; (n)=number of subjects with a determinate IgG antibody concentration to the given serotype for the three 13vPnC lots, respectively.||observed percentage of participants||95% Confidence Interval|Number
737917|NCT00444457|Secondary|Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Infant Series|Percentage of participants achieving predefined antibody threshold ≥0.35mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.|1 month after the infant series (7 months of age)|Evaluable immunogenicity population; (n)=number of subjects with a determinate IgG antibody concentration to the given serotype for the three 13vPnC lots, respectively.||observed percentage of participants||95% Confidence Interval|Number
737918|NCT00444457|Primary|Percentage of Participants Achieving Predefined Antibody Level ≥10.0 Milli-International Units Per Milliliter (mIU/mL) for Hepatitis B in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series|Percentage of participants achieving predefined antibody threshold ≥10.0 mIU/ mL along with the corresponding 95% CI for concomitant antigen hepatitis B are presented. Exact 2-sided CI was based on the observed proportion of participants. Combined 13vPnC group includes participants randomized to pilot lot 1, pilot lot 2, or the manufacturing lot.|1 month after the infant series (7 months of age)|Evaluable immunogenicity population; N=number of participants analyzed with a determinate post-third dose IgG antibody concentration to the given concomitant vaccine component.||observed percentage of participants||95% Confidence Interval|Number
737919|NCT00444457|Primary|Percentage of Participants Achieving Predefined Antibody Level ≥1:8 for Poliovirus in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series|Percentage of participants achieving predefined antibody threshold ≥1:8 along with the corresponding 95% CI for concomitant antigen poliovirus type 1, type 2, and type 3 (Sabin strains 1, 2, 3) are presented. Exact 2-sided CI was based on the observed proportion of participants. Combined 13vPnC group includes participants randomized to pilot lot 1, pilot lot 2, or the manufacturing lot.|1 month after the infant series (7 months of age)|Evaluable immunogenicity population; N=number of participants analyzed with a determinate post-third dose IgG antibody concentration to the given concomitant vaccine component; n)=number of participants with an antibody titer ≥ prespecified level for given concomitant vaccine antigen for combined 13vPnC and 7vPnC, respectively.||observed percentage of participants||95% Confidence Interval|Number
737920|NCT00444457|Primary|Percentage of Participants Achieving Predefined Antibody Level ≥0.1 International Units Per Milliliter (IU/mL) for Tetanus Toxoid in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series|Percentage of participants achieving predefined antibody threshold ≥0.1 IU/ mL along with the corresponding 95% CI for concomitant antigen tetanus toxoid are presented. Exact 2-sided CI was based on the observed proportion of participants. Combined 13vPnC group includes participants randomized to pilot lot 1, pilot lot 2, or the manufacturing lot.|1 month after the infant series (7 months of age)|Evaluable immunogenicity population. Combined 13vPnC group includes participants who received pilot lot 1, pilot lot 2, or manufacturing lot; N=number of participants analyzed with a determinate post-third dose IgG antibody concentration to the given concomitant vaccine component.||observed percentage of participants||95% Confidence Interval|Number
737921|NCT00444457|Primary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Infant Series|Antibody geometric mean concentration (GMC) as measured by micrograms per milliliter (mcg/mL) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.|1 Month after the infant series (7 Months of age)|Evaluable immunogenicity population: treatments as randomized at all expected doses, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations; (n)=number of participants with IgG antibody concentration to given serotype for the three 13vPnC lots, respectively.||GMC mcg/mL||95% Confidence Interval|Geometric Mean
737922|NCT00444535|Secondary|Progression-free Survival|Progression-free survival (PFS) = time from treatment start date until the first documented sign of disease progression, as defined by the investigator, or death due to any cause. For participants who did not progress or die at the time of reporting, PFS data were censored at the time of the last radiological assessment.|Baseline through End of Study (end of treatment; end of treatment for each participant was dependent on when the participant withdrew from study therapy due to disease progression, an adverse event, or participant decision)|ITT Population||weeks||95% Confidence Interval|Median
737923|NCT00444535|Secondary|Clinical Benefit|Clinical benefit is defined as defined as the percentage of participants with evidence of a confirmed CR (complete resolution of lesions observed at baseline) or PR (30% reduction from baseline sum of longest diameters or complete resolution of target lesions and no progression in non-target lesions) at any time or stable disease (insufficient response to qualify for CR or PR, and insufficient increase in tumor burden to qualify for progressive disease [20% increase in sum of longest diameters, new lesions, or symptomatic progression]) for at least 24 weeks per RECIST.|Baseline through End of Study (end of treatment; end of treatment for each participant was dependent on when the participant withdrew from study therapy due to disease progression, an adverse event, or participant decision)|ITT Population||Percentage of participants|||Number
737947|NCT00444600|Other Pre-specified|Change From Moderately Severe Non-proliferative Diabetic Retinopathy or Better From Baseline to 1-year|113 eyes had missing or ungradable photos at 1 year. Criteria are based on the ETDRS fundus photographic risk factors for the progression of diabetic retinopathy. ETDRS report no. 12. Ophthalmology 1991; 98:823-833|from baseline to 1 Year|||Eyes|Participants||Number
737924|NCT00444535|Secondary|Overall Response|The percentage of participants with measurable disease with a best response of partial response (PR, 30% reduction from baseline sum of longest diameters or complete resolution of target lesions and no progression in non-target lesions) or complete response (CR, complete resolution of lesions observed at baseline) per RECIST was measured. The first assessment of overall response was at Week6; however, the participants were assessed for response until treatment ended.|Week 6 through End of Study (until end of treatment; end of treatment for each participant was dependent on when the participant withdrew from study therapy due to disease progression, an adverse event, or participant decision)|ITT Population. Analysis was done on 45 of 52 participants, as 7 participants had withdrawn before Week 6.||Percentage of participants|||Number
737925|NCT00444535|Primary|Percentage of Participants Reaching Week 12 Without Disease Progression|The progression-free survival rate was evaluated by the investigator after 12 weeks of treatment and was defined as the number of participants with no evidence of disease progression (20% increase in sum of longest diameters, new lesions, or symptomatic progression) per Response Evaluation Criteria in Solid Tumors (RECIST) or death from any cause for a minimum of 84 days (12 weeks).|Week 12|Intent-to-Treat (ITT) Population: all enrolled participants, regardless of whether or not they received any study medication||Percentage of participants|||Number
737926|NCT00444587|Secondary|Mean Left Ventricular Ejection Fraction|Left ventricular ejection fraction (LVEF) is a measure of the percent of blood ejected from the ventricle in one heartbeat. It is a measure of cardiac function and was assessed by echocardiogram or multigated angiogram at Visit 0 [Screening period (6 weeks prior to enrollment)] and final study assessments (Up to 5 years).|Visit 0 [Screening period (6 weeks prior to enrollment)] and final study assessments (Up to 5 years).|The Safety Population included all participants who entered the trial and received at least one dose of trial medication. n = the number of participants analyzed at a given time point.||percent of blood pumped from LV chamber]||Standard Deviation|Mean
737927|NCT00444587|Secondary|Hematology Safety Laboratory Parameter: Mean Platelets Counts|Participants in the study were evaluated for the platelets at Visit 1 and final study assessments. Platelet counts were not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.|Visit 1 [Screening Period (6 weeks prior to enrollment)] and final study assessments (Up to 5 years)|The Safety Population included all participants who entered the trial and received at least one dose of trial medication. n = the number of participants analyzed at a given time point.||Number of cells x 10^9/L||Standard Deviation|Mean
737928|NCT00444587|Secondary|Hematology Safety Laboratory Parameters: Percent of Differential for Neutrophils, Basophils, Eosinophils, Lymphocytes and Monocytes Counts|"Participants in the study were evaluated for the Neutrophils, Basophils, Eosinophils, Lymphocytes and Monocytes at Visit 1 and final study assessments.
Neutrophils, Basophils, Eosinophils, Lymphocytes and Monocytes counts were not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice."|Visit 1 [Screening Period (6 weeks prior to enrollment)] and final study assessments (Up to 5 years)|The Safety Population included all participants who entered the trial and received at least one dose of trial medication. n = the number of participants analyzed at a given time point.||percent of differential||Standard Deviation|Mean
737929|NCT00444587|Secondary|Hematology Safety Laboratory Parameters: Mean Total Leukocytes Counts|Participants in the study were evaluated for the total leukocytes up to 5 years. Total leukocytes counts were not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.|Visit 1 [Screening Period (6 weeks prior to enrollment)] and final study assessments (Up to 5 years)|The Safety Population included all participants who entered the trial and received at least one dose of trial medication. n = the number of participants analyzed at a given time point.||10^9 leukocytes/L||Standard Deviation|Mean
737930|NCT00444587|Secondary|Hematology Safety Laboratory Parameters: Mean Hemoglobin Levels|Participants in the study were evaluated for the Hemoglobin up to 5 years. Hemoglobin levels were not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.|Visit 1 [Screening Period (6 weeks prior to enrollment)] and final study assessments (Up to 5 years)|The Safety Population included all participants who entered the trial and received at least one dose of trial medication. n = the number of participants analyzed at a given time point.||grams per deciliter||Standard Deviation|Mean
737931|NCT00444587|Secondary|Biochemistry Safety Laboratory Parameters: Mean Urea, Sodium and Potassium Levels|Participants in the study were evaluated for the biochemical safety laboratory parameters urea, sodium and potassium. Urea, sodium and potassium levels were not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.|Visit 1 [Screening Period (6 weeks prior to enrollment)] and Final study assessments (Up to 5 years)|The Safety Population included all participants who entered the trial and received at least one dose of trial medication. n = the number of participants analyzed at a given time point.||Millimole per liter||Standard Deviation|Mean
737932|NCT00444587|Secondary|Biochemistry Safety Laboratory Parameters: Mean Albumin Levels|Participants in the study were evaluated for the albumin at Visit 1 and Final study assessments. Albumin levels were not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.|Visit 1 [Screening Period (6 weeks prior to enrollment)] and Final study assessments (Up to 5 years)|The Safety Population included all participants who entered the trial and received at least one dose of trial medication. n = the number of participants analyzed at a given time point.||gram per liter||Standard Deviation|Mean
737933|NCT00444587|Secondary|Biochemistry Safety Laboratory Parameters: Mean Total Bilirubin and Serum Creatinine Levels|Participants in the study were evaluated for the total bilirubin and serum creatinine. Total Bilirubin and serum creatinine levels were not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.|Visit 1 [Screening Period (6 weeks prior to enrollment)] and Final study Assessments (Up to 5 years)|The Safety Population included all participants who entered the trial and received at least one dose of trial medication. n = the number of participants analyzed at a given time point.||Micromole/liter||Standard Deviation|Mean
737948|NCT00444600|Other Pre-specified|Eyes With Alternative Treatments Prior to the 1-year Visit|Each combination of treatment only counted once.|1 Year|||Eyes|Participants||Number
737934|NCT00444587|Secondary|Biochemistry Safety Laboratory Parameters: Mean Serum Glutamic Oxaloacetic Transaminase, Serum Glutamic-pyruvic Transaminase and Alkali Phosphatase Levels|Participants in the study were evaluated for the serum glutamic oxaloacetic transaminase (SGOT), serum glutamic-pyruvic transaminase (SGPT) and alkali phosphatase (ALP) at Visit 1 and final study assessments (Up to 5 years). Serum glutamic oxaloacetic transaminase, Serum glutamic-pyruvic transaminase and Alkali Phosphatase levels were not assessed for ‘Only Chemotherapy’ group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.|Visit 1 [Screening Period (6 weeks prior to enrollment)] and Final study Assessments (Up to 5 years)|The Safety Population included all participants who entered the trial and received at least one dose of trial medication. n = the number of participants analyzed at a given time point.||Units per liter||Standard Deviation|Mean
737935|NCT00444587|Secondary|Number of Participants With Any Adverse Events and Serious Adverse Events|An adverse event (AE) is any untoward medical occurrence in a participant who is administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.|Up to 5 years|The Safety Population included all participants who entered the trial and received at least one dose of trial medication.||Number of participants|||Number
737936|NCT00444587|Secondary|Overall Survival|Overall Survival is defined as the time (number of days) between enrollment and the date of death due to any cause. Overall survival was not assessed for ‘Only Chemotherapy’ group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.|Up to 5 years|The Full-Analysis-Set included all participants who were enrolled and had at least one valid primary efficacy variable on active treatment. Only those participants with data available were analyzed.||Days||95% Confidence Interval|Median
737937|NCT00444587|Secondary|Median Time to Treatment Failure|Time to treatment failure is defined as a composite endpoint measuring time (number of days) from enrollment to discontinuation of treatment or change in treatment for any reason, including disease progression, treatment toxicity and death. Median time to treatment failure was not assessed for ‘Only Chemotherapy’ group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.|Up to 5 years|The Full-Analysis-Set included all participants who were enrolled and had at least one valid primary efficacy variable on active treatment. Only those participants who experienced treatment failure were analyzed.||Days||95% Confidence Interval|Median
737938|NCT00444587|Secondary|Clinical Benefit Rate|Clinical benefit rate (CBR) was defined as the percentage of participants taking a benefit from the treatments. CBR includes 1) Complete response (CR): disappearance of all target lesions and all non-target non-measurable lesions 2) Partial response (PR) : >=30% decrease in the sum of the longest diameter of target lesions and 3) Stable disease (SD): non-PR and non-progressive disease. It was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST 1.0) and assessed by CT or MRI by the investigator. CBR was also assessed by computer. Clinical benefit rate was not assessed for ‘Only Chemotherapy’ group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.|Up to 5 years|The Full-Analysis-Set participants with measurable disease with CR, PR and SD. Study design was changed to single arm study because herceptin use after progression herceptin-based therapy become widespread.||Percentage of participants||95% Confidence Interval|Number
737939|NCT00444587|Secondary|Objective Response Rate|Objective response rate (ORR) is defined as the percentage of participants with tumor shrinkage of a predefined amount. It is a combination of complete response (CR) and partial response (PR) and was assessed according to the RECIST criteria 1.0. Complete response refers to the disappearance of all target lesions and all non-target non-measurable lesions. Partial Response refers to an at least 30 percent decrease in the sum of longest diameter of target lesions, taking as reference the baseline sum longest diameter. Objective response rate was not assessed for ‘Only Chemotherapy’ group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.|Up to 5 years|The Full-Analysis-Set participants with measurable disease with CR or PR||Percentage of participants||95% Confidence Interval|Number
737940|NCT00444587|Primary|Median Time to Disease Progression|Time to disease progression (TTP) in days was defined as the time from enrollment to objective disease progression (all categories other than objective disease progression was set to be censored including death before progression). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a nontarget lesion, or the appearance of new lesions. Tumor assessments were performed using computer tomography or magnetic resonance imaging. TTP as assessed by investigator, along with a recalculation done by computer algorithm is presented below. Median time was not assessed for 'Only Chemotherapy’ group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.|Up to 5 years|The Full-Analysis-Set included all participants who were enrolled and had at least one valid primary efficacy variable on active treatment. n = Numbers of participants included in this analysis.||Days||95% Confidence Interval|Median
737941|NCT00444600|Other Pre-specified|Major Ocular Adverse Events During First Year of Follow-Up||1 Year|||Eyes|Participants||Number
737942|NCT00444600|Secondary|Mean Change in Optical Coherence Tomography Retinal Volume From Baseline to 1 Year||from baseline to 1 Year|||mm^3|Participants|Standard Deviation|Mean
737943|NCT00444600|Secondary|Mean Optical Coherence Tomography Retinal Volume at 1 Year||1 Year|||mm^3|Participants|Standard Deviation|Mean
737944|NCT00444600|Other Pre-specified|Cardiovascular Events According to Antiplatelet Trialists' Collaboration Through 1 Year|Antiplatelet Trialists' Collaboration is a collaborative overview of randomised trials of antiplatelet therapy - I: Prevention of death, myocardial infarction, and stroke by prolonged antiplatelet therapy in various categories of patients. Antiplatelet Trialists' Collaboration. MBJ 1994; 308:81-106. Nonfatal cerebrovascular accident includes ischemic or hemorrhagic or unknown events. Vascular death includes death from any potential vascular or unknown cause.|1 Year|Study participants with 2 study eyes are assigned to the non-sham group. Multiple events within a study participant are only counted once per event.||Participants|||Number
737951|NCT00444600|Primary|Change in Visual Acuity From Baseline to 1 Year Grouped by Diabetic Retinopathy Severity|Change in best correct visual acuity letter score from baseline to one year as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale 97, worst 0.|from baseline to 1 Year|||Letters|Participants|Standard Deviation|Mean
737952|NCT00444600|Primary|Change in Visual Acuity From Baseline to 1 Year Grouped by Optical Coherence Tomography Central Subfield Thickness|Change in best correct visual acuity letter score from baseline to one year as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale 97, worst 0.|from baseline to 1 Year|||Letters|Participants|Standard Deviation|Mean
737953|NCT00444600|Primary|Change in Visual Acuity From Baseline to 1 Year Grouped by Baseline Visual Acuity Letter Score|Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale 97, worst 0.|from baseline to 1 Year|||Letters||Standard Deviation|Mean
737954|NCT00444600|Primary|Change in Visual Acuity From Baseline to 1 Year Among Eyes That Had Prior Treatment for Diabetic Macular Edema||from baseline to 1 Year|||Letters||Standard Deviation|Mean
737955|NCT00444600|Primary|Change in Visual Acuity From Baseline to 1 Year Among Eyes That Were Pseudophakic at Baseline||from baseline to 1 Year|||Letters|Participants|Standard Deviation|Mean
737956|NCT00444600|Other Pre-specified|Distribution of Logarithmic Transformation of Optical Coherence Tomography (LogOCT) Improvement and Worsening|Logarithmic transformation of optical coherence tomography central subfield thickness is calculated by taking the log base 10 of the ratio of the central subfield thickness divided by 200 and rounding to the nearest hundredth. The change is the change in the log values.|1 Year|||Eyes|Participants||Number
737957|NCT00444600|Other Pre-specified|Central Subfield Thickness < 250 With at Least a 25 Micron Decrease From Baseline to 1 Year||1 Year|||Eyes|Participants||Number
737958|NCT00444600|Primary|Distribution of Change in Visual Acuity (Letters) From Baseline to 1 Year|Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method.|from baseline to 1 Year|For eyes without any 1-year data the last observation carried forward method was used to impute data for the primary analysis.||Eyes|Participants||Number
737959|NCT00444600|Primary|Mean Change in Visual Acuity (Letters) From Baseline to 1 Year Adjusted for Baseline Visual Acuity|Change in best correct visual acuity letter score from baseline to one year as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale 97, worst 0.|from baseline to 1 Year|For eyes without any 1-year data the last observation carried forward method was used to impute data for the primary analysis. followed intention to treat principle.||Letters|Participants|Standard Deviation|Mean
737960|NCT00444600|Secondary|Number of Injections in First Year|Maximum possible number of injections for each of the following groups: sham+prompt laser=13 sham injections;ranibizumab+prompt laser=13 ranibizumab injections; ranibizumab+deferred laser=13 ranibizumab injections; triamcinolone+prompt laser=4 triamcinolone injections and 9 sham injections.|from baseline to 1 year|Sham+prompt laser group listed median excludes 56 eyes among 163 participants with 2 study eyes that were unmasked at baseline because the participant's other eye was in the ranibizumab+deferred laser group, precluding sham injections for the study eye assigned to sham+prompt laser.||Injections|Participants|Inter-Quartile Range|Median
737961|NCT00444600|Secondary|Change in Retinal Thickening of Central Subfield on Optical Coherence Tomography From Baseline to 1 Year|Negative change denotes an improvement.|from baseline to 1 year|||microns|Participants|Standard Deviation|Mean
737962|NCT00444626|Secondary|Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period|"Count of participants with treatment-emergent adverse events (AEs) from the time of injection for the repeat treatment period up to week 47. AEs are presented regardless of relationship to study device and/or procedure.
If a participant had more than one occurrence of the same AE, he/she was counted only once. The most severe occurrence of an AE, as well as most extreme relationship of the AE to the device, was indicated in cases of multiple occurrences of the same AE. For AEs by relationship, procedure-related and device-related AEs are not mutually exclusive and therefore are not additive."|weeks 36 up to 47 weeks|Safety Population for repeat treatment.||Participants|||Number
737963|NCT00444626|Secondary|Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period|"Counts of participants with treatment-emergent adverse events (AEs) from the time of injection up to Week 36. AEs are presented regardless of relationship to study device and/or procedure.
If a participant had more than one occurrence of the same AE, he/she was counted only once. The most severe occurrence of an AE, as well as the most extreme relationship of the AE to the device, was indicated in cases of multiple occurrences of the same AE. For AEs by relationship, procedure-related and device-related AEs are not mutually exclusive and therefore are not additive."|Weeks 1-36|Number of patients randomized to initial treatment phase. Safety Population.||Participants|||Number
737964|NCT00444626|Secondary|Participant Product Preference at Week 36|Participants indicated their product preference at Week 36 after Date of Optimal Correction (DOC).|Week 36|The Full Analysis Set (FAS) population includes all randomized participants who received both study treatments and had some post-treatment effectiveness data. For the effectiveness analyses based on the FAS population, participants were analyzed as randomized. The FAS population was identical to an intent-to-treat population.||Participants|||Number
737965|NCT00444626|Secondary|Participant Product Preference at Week 24|Participants indicated their product preference at Week 24 after Date of Optimal Correction (DOC).|Week 24|The Full Analysis Set (FAS) population includes all randomized participants who received both study treatments and had some post-treatment effectiveness data. For the effectiveness analyses based on the FAS population, participants were analyzed as randomized. The FAS population was identical to an intent-to-treat population.||Participants|||Number
737966|NCT00444626|Secondary|Number of Participants With at Least a 1 Point Improvement From Baseline in the Blinded Evaluator’s Assessment of Wrinkle Severity at Week 24|Count of participants with at least a 1-point improvement from Baseline in the Genzyme 6-Point Grading Scale (GGS) at Week 24. A GGS score of zero indicates no wrinkles and a score of 5 indicates very deep wrinkles with redundant folds.|Week 24|The Full Analysis Set (FAS) population includes all randomized participants who received both study treatments and had some post-treatment effectiveness data. For the effectiveness analyses based on the FAS population, participants were analyzed as randomized. The FAS population was identical to an intent-to-treat population.||Participants|||Number
737967|NCT00444626|Secondary|Change From Baseline in the Blinded Evaluator’s Assessment of Nasolabial Folds (NLF) Wrinkle Severity at Week 36|"Mean change between Baseline and the Week 36 score (Baseline minus week 36 scores) in the blinded evaluators' assessments of NLF wrinkle severity. A positive value for the mean change indicates an improvement.
Genzyme 6-Point Grading Scale (GGS) for NLF was used for the assessment. A GGS score of zero indicates no wrinkles and a score of 5 indicates very deep wrinkles with redundant folds."|Week 36|The Full Analysis Set (FAS) population includes all randomized participants who received both study treatments and had some post-treatment effectiveness data. For the effectiveness analyses based on the FAS population, participants were analyzed as randomized. The FAS population was identical to an intent-to-treat population.||Units on a scale|Participants|Standard Deviation|Mean
737968|NCT00444626|Secondary|Participant’s Pain Assessment During the Initial Treatment Measured on a Visual Analog Scale (VAS)|The pain experienced by each participant at the time of injection (time 0) and at 15 and 30 minutes after injection during the initial treatment visit was evaluated. Pain was measured using a VAS of 0 mm (no pain) to 100 mm (extreme pain).|Day 1|The Full Analysis Set (FAS) population includes all randomized participants who received both study treatments and had some post-treatment effectiveness data. For the effectiveness analyses based on the FAS population, participants were analyzed as randomized. The FAS population was identical to an intent-to-treat population.||Units on a scale||Standard Deviation|Mean
737969|NCT00444626|Primary|Change From Baseline in the Blinded Evaluator’s Assessment of Nasolabial Fold (NLF) Wrinkle Severity at Week 24|"This was a comparison of the mean change between Baseline and the Week 24 score (baseline minus week 24 scores) in the blinded evaluators' assessments of NLF wrinkle severity. A positive value for the mean change indicates an improvement.
Genzyme 6-Point Grading Scale (GGS) for NLF was used for the assessment. A GGS score of zero indicates no wrinkles and a score of 5 indicates very deep wrinkles with redundant folds."|Week 24|The Full Analysis Set (FAS) population includes all randomized participants who received both study treatments and had some post-treatment effectiveness data. For the effectiveness analyses based on the FAS population, participants were analyzed as randomized. The FAS population was identical to an intent-to-treat population.||Units on a scale|Participants|Standard Deviation|Mean
737970|NCT00444795|Secondary|Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD) According to Response Evaluation Criteria in Solid Tumors (RECIST)|The antitumor efficacy was measured by objective tumor assessments according to the RECIST of uni-dimensional evaluation. CR was defined as disappearance of all target and non-target lesions, and no new lesions. PR was defined as disappearance of all target lesions, a persistence of ≥1 non-target lesions, no new lesions; or a ≥30% decrease in the sum of the longest dimensions of the target lesions, no unequivocal progression of existing nontarget lesions, no new lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), no unequivocal progression of existing non-target lesions, and no new lesions. PD was defined as a ≥20% increase in the sum of the longest dimensions of the target lesions; or unequivocal progression of existing non-target lesions, or the appearance of ≥1 new lesions.|At the end of study treatment, average of 23.2 weeks.|Intent-to-treat Analysis Set: Participants who administered Sutene at least once.||Percentage of Participants||95% Confidence Interval|Number
737971|NCT00444795|Primary|Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), Unexpected AEs/ADRs, and Unexpected SAEs/SADRs|An AE was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have had a causal relationship with the treatment or usage. All AEs reported after the start of administration of Sutene were considered as treatment-emergent and summarized. All AEs, except for those with causal relationship to the study drug assessed as “unlikely” or “no” (for data that came from Study A6181037), were considered as ADRs. Unexpected AEs/ADRs were classified by medical review with reference to the local product document and confirmed by Pfizer.|From the time that the participant signed data privacy statement through and including 28 calendar days after the last administration of the study drug, average of 27.2 weeks.|Safety Analysis Set||Percentage of Participants||95% Confidence Interval|Number
737972|NCT00444912|Secondary|Number of Participants With Durable Engraftment 12 Months After Transplantation|The number of participants maintaining a durable graft 12 months after autologous transplantation. A durable graft is defined as the maintenance of normal blood counts.|Approximately 13 months (12 months post-transplant )|Evaluable population of participants who received a stem cell transplant and had a 12-month assessment.||participants|||Number
737973|NCT00444912|Secondary|The Percentage of CD19+CD3-CD14- B-cells of the Total Cells on the First Apheresis Day||Day 5|Full Analysis Set (FAS) includes all participants who received at least 1 dose of plerixafor.||percentage of total cells||Full Range|Median
737974|NCT00444912|Secondary|Median Level of CD19+CD2-CD14- B-cells Twelve Months Post-Transplant||13 months (12 months post-transplant)|Evaluable population of participants who received a stem cell transplant and had assessment performed 12 months post-transplant.||cells / μL||Full Range|Median
737975|NCT00444912|Secondary|Median Level of CD19+CD2-CD14- B-cells Six Months Post-Transplant||Approximately 7 months (6 months post-transplant)|Evaluable population of participants who received a stem cell transplant and had assessment performed 6 months post-transplant.||cells / μL||Full Range|Median
737976|NCT00444912|Secondary|Median Number of Days to Lymphocyte Engraftment|Median number of days from transplantation to lymphocyte engraftment which was defined as lymphocyte counts ≥5*10^8/L. Time to engraftment corresponded to the first day that criteria were met.|Days post transplantation (approximately Day 40)|Evaluable population of participants who received a stem cell transplant and had lymphocyte engraftment.||days||Full Range|Median
737977|NCT00444912|Secondary|Median Number of Days to Platelet (PLT) Engraftment|Median number of days from transplantation to PLT engraftment which was defined as platelet counts ≥20*10^9/L without transfusion for the preceding 7 days or platelet counts ≥50*10^9/L for one day. Time to engraftment corresponded to the first day that the criteria were met.|Days post transplantation (approximately Day 40)|Evaluable population of participants who received a stem cell transplant and had PLT engraftment.||days||Full Range|Median
737978|NCT00444912|Secondary|Median Number of Days to Polymorphonuclear Leukocyte (PMN) Engraftment|Median number of days from transplantation to PMN engraftment which was defined as PMN counts ≥0.5*10^9/L for 3 consecutive days or ≥1.0*10^9/L for 1 day. Time to engraftment corresponded to the first day that the criteria were met.|Days post transplantation (approximately Day 40)|Evaluable population of participants who received a stem cell transplant and had PMN engraftment||days||Full Range|Median
737979|NCT00444912|Secondary|Median Number of Apheresis Days Required to Reach the Target of 5*10^6 CD34+ Cells/kg|Median number of apheresis days in each treatment arm to reach the target of 5*10^6 CD34+ cells/kg.|Days 5-8|Evaluable population of participants who achieved ≥5*10^cells/kg collected during apheresis.||days||Full Range|Median
737980|NCT00444912|Secondary|Median Number of Apheresis Days Required to Reach a Minimum of 3*10^6 CD34+ Cells/kg|Median number of apheresis days in each treatment arm to collect a minimum of 3*10^6 CD34+ cells/kg.|Days 5-8|Evaluable population of participants who achieved ≥3*10^cells/kg collected during apheresis.||days||Full Range|Median
737981|NCT00444912|Secondary|Median Fold Increase in the Number of CD34+ Cells After Plerixafor Administration|Fold Increase = (Pre-Apheresis CD34+ cells/Pre-Plerixafor CD34+ cells).|Days 4-5|Evaluable population of participants with peripheral blood CD34+ measurements on Days 4 and 5.||fold increase||Full Range|Median
737982|NCT00444912|Secondary|Median Cumulative Number of CD34+ Cells Collected During Apheresis|Median total number of CD34+ cells collected during apheresis.|Days 5-8|Full Analysis Set (FAS) includes all participants who received at least 1 dose of plerixafor.||CD34+ cells (*10^6 / kg)||Full Range|Median
737983|NCT00444912|Primary|Summary of Adverse Events (AEs)|Number of participants with adverse events (AEs) collected from Day 1 (start of G-CSF mobilization in participants with CD20- lymphoma or start of rituximab in participants with CD20+ lymphoma) to the day before starting chemotherapy. AEs were graded by the investigator using the World Health Organization (WHO) Adverse Event Grading Scale and were assessed for seriousness and relatedness to study treatment.|Day 1 and up to Day 59 (maximum time before start of chemotherapy)|Safety Population: all participants who received at least 1 dose of study drug (G-CSF, plerixafor, or rituximab)||participants|||Number
737984|NCT00444925|Post-Hoc|Diary Dry Rates|Diary dry rate: number of subjects with no urgency urinary incontinence episode reported in the 3 day diary at the respective time-point; based on USS: 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).|Week 1, Week 4, Week 12|FAS; only subjects with baseline urgency urinary incontinence >0 per 24 hours are included; n=number of subjects in the respective category at observation (Week 1, Week 4, Week 12).||participants|||Number
737985|NCT00444925|Secondary|Change From Baseline in OAB-q: Health Related Quality of Life (HRQL) at Week 12 (End of Treatment).|HRQL domain and total raw score derived as sum of scores (6-point scale: 1=not at all/none of the time; 6=a very great deal/all of the time). Transformed score (Total HRQL or domain)=[(Highest possible raw score-Actual total raw score)/Raw score range]x100. Higher transformed scores indicative of better HRQL. Positive change in HRQL scores indicates improvement. Change: score at observation minus score at baseline.|Baseline, Week 12|FAS; (n)=number of subjects with non-missing numerical change from baseline to Week 12 for placebo, Tolterodine ER, and Fesoterodine, respectively.||score on scale||Standard Error|Least Squares Mean
737986|NCT00444925|Secondary|Change From Baseline in Overactive Bladder Questionnaire (OAB-q): Symptom Bother Score at Week 12 (End of Treatment).|Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score - lowest possible value of raw score)/by raw score range * 100]. Higher transformed scores indicative of greater symptom bother. Negative change in Symptom Bother score indicates improvement. Change calculated as score at observation minus score at baseline.|Baseline, Week 12|FAS; (n)=number of subjects with non-missing numerical change from baseline to Week 12 for placebo n=289; Tolterodine ER n=589; Fesoterodine n=571.||score on scale||Standard Error|Least Squares Mean
737987|NCT00444925|Secondary|Change From Baseline in Urgency Perception Scale (UPS). UPS Equals Patient Perception of Urgency Scale (PPUS) in Protocol.|Number of subjects in 3-point category: improvement [>=1-point improvement]; no change; deterioration [>=1-point decrease], based on UPS score (rated on 3-point scale: 1=not able to hold urine; 3=able to finish what I am doing). Score change calculated as score at observation minus score at baseline; re-scaled to 3-point categorical variables.|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of subjects with non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, Tolterodine ER, and Fesoterodine, respectively.||participants|||Number
737988|NCT00444925|Secondary|Change From Baseline in Patient Perception of Bladder Condition (PPBC).|Number of subjects in 4-point category: >= to 2 points improvement [major improvement]; 1 point improvement [minor improvement]; no change; deterioration, based on PPBC score (rated on 6-point scale: 1=no problems at all; 6=many severe problems). Score change: score at observation minus score at baseline; re-scaled to 4-point categorical variables.|Baseline, Week 1, Week, 4, Week 12|FAS; (n)=number of subjects with non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, Tolterodine ER, and Fesoterodine, respectively.||participants|||Number
737989|NCT00444925|Secondary|Change From Baseline in Frequency-Urgency Sum (Formerly Known as Urinary Sensations Scale Sum in Protocol) Per 24 Hours.|Frequency-Urgency Sum rating per 24 hours calculated as mean rating scores on the USS multiplied by the mean number of micturitions per 24 hours at that visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as mean at observation minus mean at baseline.|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of subjects with non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, Tolterodine ER, and Fesoterodine, respectively.||score on scale||Standard Error|Least Squares Mean
737990|NCT00444925|Secondary|Change From Baseline in Mean USS Rating Per Micturition Per 24 Hours.|Mean USS rating calculated as the sum of rating scores on USS per 24 hours divided by the mean number of micturitions per 24 hours at that visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as mean at observation minus mean at baseline.|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of subjects with non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, Tolterodine ER, and Fesoterodine, respectively.||score on scale||Standard Error|Least Squares Mean
737991|NCT00444925|Secondary|Percent Change From Baseline of Severe Urgency Episodes Per 24 Hours.|Percent change calculated as change in severe urgency episodes (USS rating >= to 4 in diary ) per 24 hours at that visit divided by the baseline number of severe urgency episodes per 24 hours, multiplied by 100. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).|Baseline, Week 1, Week 4, Week 12|FAS; Subjects reporting this symptom at baseline; (n)=number of subjects with baseline severe urgency episodes >0 per 24 hours, non-missing change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, Tolterodine ER, and Fesoterodine, respectively.||percent change||Full Range|Median
737992|NCT00444925|Secondary|Change From Baseline in Mean Number of Severe Urgency Episodes Per 24 Hours.|Mean number of severe urgency episodes (USS rating >= to 4 in diary ) per 24 hours: sum of all micturitions divided by total number of diary days collected at that visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as mean at observation minus mean at baseline.|Baseline, Week 1, Week 4, Week 12|FAS; Subjects reporting this symptom at baseline; (n)=number of subjects with baseline severe urgency episodes >0 per 24 hours, non-missing change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, Tolterodine ER, and Fesoterodine, respectively.||severe urgency episodes per 24 hours||Standard Error|Least Squares Mean
737993|NCT00444925|Secondary|Percent Change From Baseline of Urgency Episodes Per 24 Hours.|Percent change of urgency episodes (USS rating >= to 3 in diary) per 24 hours calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100. USS: 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).|Baseline, Week 1, Week 4, Week 12|FAS; Subjects reporting this symptom at baseline; (n)=number of subjects with baseline urgency episodes >0 per 24 hours, non-missing change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, Tolterodine ER, and Fesoterodine, respectively.||percent change||Full Range|Median
737994|NCT00444925|Secondary|Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours.|Mean number urgency episodes (USS rating >= to 3 in diary) per 24 hours calculated as sum of all micturitions divided by total number of diary days collected at visit. USS: 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as mean at observation minus mean at baseline.|Baseline, Week 1, Week 4, Week 12|FAS; Subjects reporting this symptom at baseline; (n)=number of subjects with baseline urgency episodes >0 per 24 hours, non-missing change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, Tolterodine ER, and Fesoterodine, respectively.||urgency episodes per 24 hours||Standard Error|Least Squares Mean
737995|NCT00444925|Secondary|Percent Change From Baseline of Nocturnal Micturitions Per 24 Hours.|Percent change of nocturnal micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (ie, 100% *(Week 12 or 4 - baseline)/baseline). Nocturnal (Bedtime) was defined as the time the subject went to bed until he/she arose to start the next day.|Baseline, Week 1, Week 4, Week 12|FAS; Subjects reporting this symptom at baseline; (n)=number of subjects with baseline nocturnal micturitions >0 per 24 hours, non-missing change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, Tolterodine ER, and Fesoterodine, respectively.||percent change||Full Range|Median
737996|NCT00444925|Secondary|Change From Baseline in Mean Number of Nocturnal Micturitions Per 24 Hours.|Mean number of nocturnal micturitions per 24 hours was calculated as the sum of all micturitions divided by the total number of diary days collected at that visit. Nocturnal (Bedtime) was defined as the time the subject went to bed until he/she arose to start the next day.|Baseline, Week 1, Week 4, Week 12|FAS; Subjects reporting this symptom at baseline; (n)=number of subjects with baseline nocturnal micturitions >0 per 24 hours, non-missing change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, Tolterodine ER, and Fesoterodine, respectively.||nocturnal micturitions per 24 hours||Standard Error|Least Squares Mean
737997|NCT00444925|Secondary|Percent Change From Baseline of Micturitions Per 24 Hours.|Percent change of micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (ie, 100% *(Week 12 or 4 - baseline)/baseline).|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of subjects with non-missing percent change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, Tolterodine ER, and Fesoterodine, respectively.||percent change||Full Range|Median
737998|NCT00444925|Secondary|Change From Baseline in Mean Number of Micturitions Per 24 Hours.|The mean number of micturitions was calculated as the sum of all micturitions divided by the total number of diary days collected at that visit. Change calculated as mean at observation minus mean at baseline.|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of subjects with non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, Tolterodine ER, and Fesoterodine, respectively.||number of micturitions per 24 hours||Standard Error|Least Squares Mean
737999|NCT00444925|Secondary|Change From Baseline in Mean Voided Volume Per Micturition.|Mean voided volume calculated as sum of voided volume divided by the total number of micturition episodes with a recorded voided volume greater than 0 in the 3-day diary at that visit.|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of subjects with non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, Tolterodine ER, and Fesoterodine, respectively.||voided volume per micturition||Standard Error|Least Squares Mean
738581|NCT00450580|Secondary|Number of Participants With HIV-1 RNA <400 Copies/mL (Primary Endpoint) at Week 48 Categorised by Baseline Viral Load, TLOVR Analysis|The number of participants with HIV-1 RNA <400 copies/mL at Week 48 was determined (by analysis of blood draw) and categorised by baseline viral load (BVL).|Week 48|ITT-E Population||Participants|||Number
738000|NCT00444925|Secondary|Percent Change From Baseline of UUI Episodes Per 24 Hours.|UUI episodes per 24 hours calculated as total number of micturitions with USS of 5 in diary. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as UUI episodes per 24 hours at observation divided by baseline number of UUI episodes per 24 hours, multiplied by 100.|Baseline, Week 1, Week 4, Week 12|FAS; Subjects reporting this symptom at baseline; (n)=number of subjects with baseline UUI>0 per 24 hours, non-missing change from baseline to respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, Tolterodine ER, and Fesoterodine, respectively.||percent change||Full Range|Median
738001|NCT00444925|Secondary|Change From Baseline in Mean Number of UUI Episodes Per 24 Hours at Week 1 and Week 4.|UUI episodes per 24 hours calculated as total number of micturitions with Urinary Sensation Scale (USS) of 5 divided by total number of diary days collected at visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as mean at observation minus mean at baseline.|Baseline, Week 1, Week 4|FAS; Subjects reporting this symptom at baseline; (n)=number of subjects with baseline UUI>0 per 24 hours, non-missing change from baseline to respective post-baseline value (Week 1 or Week 4 [Last Observation Carried Forward (LOCF)]) for placebo, Tolterodine ER, and Fesoterodine, respectively.||number of episodes per 24 hours||Standard Error|Mean
738002|NCT00444925|Primary|Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12 (End of Treatment).|UUI per 24 hours: total number of micturitions with Urinary Sensation Scale (USS) of 5 divided by total number of diary days collected at visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change: mean at observation minus mean at baseline.|Baseline, Week 12|Full analysis set (FAS): took at least 1 dose of assigned treatment, contributed data to at least 1 baseline or post-baseline efficacy assessment, and excluded 107 subjects from two study sites with significant Good Clinical Practices (GCP) deviations. The decision to exclude that data was made while the study was still blinded.||number of episodes per 24 hours||Standard Error|Mean
738003|NCT00444951|Secondary|Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination||Day 0 to Day 7 Post-vaccination|Safety analysis was on all vaccinated participants, intend-to-treat population (Safety analysis set)||Participants|||Number
738004|NCT00444951|Secondary|Percentage of Participants With At Least a 4-Fold Rise in Titers Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Post-Menatcra® Vaccination||Baseline (Day 0) and Day 28 After Vaccination|4-Fold rise titers were determined in the per-protocol population.||Percentage of Participants|||Number
738005|NCT00444951|Primary|Geometric Mean Titers (GMTs) of Vaccine Serogroups Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination||Baseline (Day 0) and Day 28 after vaccination|Geometric mean titers were evaluated in participants who received vaccine injection (full analysis set population).||Titers (1/dil)||95% Confidence Interval|Geometric Mean
738054|NCT00445315|Primary|Ratio of 6 Beta-Hydroxyl Cortisol to Cortisol: Day 8|Urine 6 beta-hydroxyl cortisol and cortisol concentrations were measured using high performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS).|0 to 24 hours post-dose on Day 8|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters.||ratio||Standard Deviation|Geometric Mean
738014|NCT00445146|Secondary|Incidence of Mortality|The percentage of participants who died was summarized.|Up to Week 408 plus 30 days|Safety Analysis Set||percentage of participants|||Number
738015|NCT00445146|Secondary|CD4 Cell Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384||Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384|Participants in the Efficacy Analysis Set with available data were analyzed.||cells/mm^3||Standard Deviation|Mean
738016|NCT00445146|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384||Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384|Participants in the Efficacy Analysis Set with available data were analyzed. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.||percentage of participants|||Number
738017|NCT00445146|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384||Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384|Participants in the Efficacy Analysis Set with available data were analyzed. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.||percentage of participants|||Number
738018|NCT00445146|Secondary|HIV-1 RNA at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384||Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384|Participants in the Efficacy Analysis Set (enrolled participants who received at least 1 dose of EVG and had at least 1 postbaseline HIV-1 RNA or CD4 cell count measurement) with available data were analyzed.||log10 copies/mL||Standard Deviation|Mean
738019|NCT00445146|Secondary|Aspartate Aminotransferase (AST) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384||Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384|Participants in the Safety Analysis Set with available data were analyzed.||U/L||Standard Deviation|Mean
738020|NCT00445146|Secondary|Alanine Aminotransferase (ALT) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384||Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384|Participants in the Safety Analysis Set with available data were analyzed.||U/L||Standard Deviation|Mean
738021|NCT00445146|Secondary|Alkaline Phosphatase at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384||Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384|Participants in the Safety Analysis Set with available data were analyzed.||U/L||Standard Deviation|Mean
738022|NCT00445146|Secondary|Platelet Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384||Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384|Participants in the Safety Analysis Set with available data were analyzed.||10^3 cells/µL||Standard Deviation|Mean
738023|NCT00445146|Secondary|White Blood Cell (WBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384||Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384|Participants in the Safety Analysis Set with available data were analyzed.||10^3 cells/μL||Standard Deviation|Mean
738024|NCT00445146|Secondary|Red Blood Cell (RBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384||Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384|Participants in the Safety Analysis Set with available data were analyzed.||10^6 cells/μL||Standard Deviation|Mean
738025|NCT00445146|Secondary|Hemoglobin at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384||Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384|Participants in the Safety Analysis Set with available data were analyzed.||g/dL||Standard Deviation|Mean
738026|NCT00445146|Secondary|Percentage of Participants Experiencing Any Marked Treatment-Emergent Laboratory Abnormality|A 'marked abnormality’ was defined as a shift from grade 0 (or missing) at baseline to at least grade 3 postbaseline; or grade 1 at baseline to grade 4 postbaseline.|Up to Week 408 plus 30 days|Participants in the Safety Analysis Set with at least 1 postbaseline measurement were analyzed.||percentage of participants|||Number
738027|NCT00445146|Secondary|Percentage of Participants Experiencing Any Treatment-Emergent Laboratory Abnormality|Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The most severe graded abnormality from all tests was counted for each participant.|Up to Week 408 plus 30 days|Participants in the Safety Analysis Set with at least 1 postbaseline measurement were analyzed.||percentage of participants|||Number
738028|NCT00445146|Secondary|Percentage of Participants Experiencing Treatment-Emergent Adverse Events|Adverse events (AEs) occurring during treatment and for 30 days following the last dose of study drug were summarized across the participant population. A participant was counted once if they had a qualifying event.|Up to Week 408 plus 30 days|Safety Analysis Set||percentage of participants|||Number
738029|NCT00445146|Primary|Percentage of Participants Experiencing Any Treatment-Emergent Study Dug-Related Adverse Event||Up to Week 408 plus 30 days|Safety Analysis Set: enrolled participants who received at least 1 dose of EVG||percentage of participants|||Number
738030|NCT00445211|Secondary|Hospital Death During the Index Hospitalization||0-4 post surgery|||Participants|||Count of Participants
738031|NCT00445211|Secondary|Intra-aortic Balloon Pump-related Death During the Index Hospitalization||0-4 days post surgery|||Participants|||Count of Participants
738032|NCT00445211|Primary|Major Bleeding During the Index Hospitalization|Count of participants with hemorrhage associated with at least one of the following features as defined by the Thrombolysis in Myocardial Infarction (TIMI) Study Group criteria: Bleeding that results in a decrease in hemoglobin >/= 5g.dL or a hematocrit decrease of >/= 15% of baseline value; bleeding that is intracranial (confirmed by MRI or CT); bleeding that results in death.|0-4 days post surgery|Only 8 patients analyzed in Heparin group and 9 patients in non-Heparin group; data not available for remaining patients||Participants|||Count of Participants
738033|NCT00445211|Primary|Major Ischemia (Decreased Blood Flow) During the Index Hospitalization|Count of participants with loss of Doppler signal or sensation or abnormal skin temperature, mottling or pallor in lower extremity requiring surgical intervention; or other major ischemic events including ischemic stroke; recurrent unstable ischemia (unstable angina, recurrent chest pain prompting definitive treatment such as re-percutaneous transluminal coronary angiography (PTCA), coronary artery bypass grafting (CABG), administration of thrombolytics); reinfarction including clinical symptoms or new ECG changes with creatine kinase (CK) elevation and positive creatine kinase-MB isoenzyme fraction; arterial thrombosis, embolus, dissection, or perforation; compartment syndrome; renal ischemia including new renal failure or need for dialysis; small bowel or splenic infarction; mesenteric or hepatic ischemia, or deep vein thrombosis.|0-4 days post surgery|Only 8 patients analyzed in Heparin group and 9 patients in non-Heparin group; data not available for remaining patients||Participants|||Count of Participants
738034|NCT00445211|Primary|Minor Ischemia (Decreased Blood Flow) During the Index Hospitalization|Count of participants with decreased arterial flow in lower extremity as presented by diminished pulse that resolves with balloon removal, and not resulting in any impairment of body function|0-4 days post surgery|Only 8 patients analyzed in Heparin group and 9 patients in non-Heparin group; data not available for remaining patients||Participants|||Count of Participants
738035|NCT00445224|Primary|Visual Analog Pain Scale|Visual analog pain scale at end of intervention. 0 to 10 cm line with 0 representing no pain and 10 representing severe pain|8 week|||centimeters||Standard Deviation|Mean
738036|NCT00445224|Secondary|Hip Abduction Strength|Side lying Hip Abduction maximal muscular contraction with a hand held dynamometer|8 week|||(Newton*meters)/(Weight*Height)||Standard Deviation|Mean
738037|NCT00445224|Secondary|Objective Function by Step-down Task for 30 Seconds||Baseline, Mid, and Post-Intervention||||||
738038|NCT00445224|Secondary|Neuromuscular Activity by Surface Electromyographical Amplitude During Stair Descent||Baseline, Mid and Post-Intervention||||||
738039|NCT00445224|Secondary|Strength by Isometric Dynamometer||Baseline, Mid, and Post-Intervention||||||
738040|NCT00445224|Primary|Subjective Function by Lower Extremity Functional Scale Report Form||Baseline, Mid-Intervention, and Post-Intervention||||||
738041|NCT00445224|Primary|Visual Analog Pain Scale (Describing Worst Pain Felt During the Past Week)|0 to 10 cm line with 0 representing no pain and 10 representing severe pain|weekly|||centimeter||Standard Deviation|Mean
738042|NCT00445263|Secondary|Troponin Peak. Left Ventricular Ejection Fraction Before Hospital Exit. Length of Stay in USIC and Hospital. Hemorrhagic Complications.||d30||||||
738043|NCT00445263|Secondary|Coronarographic Criteria : TIMI Score at the Beginning and the End of the Procedure; Existence of an Intra-coronary Thrombus||d30||||||
738044|NCT00445263|Secondary|Therapeutic Failure (Well Defined) During the First 6 Hours. Clinical Evolution and Electrocardiography||until the exit from the hospital and at d30.||||||
738045|NCT00445263|Primary|Mortality, Myocardial Infarction and Revascularization in Emergency||d30|||participants|||Number
738046|NCT00445302|Secondary|Number of Participants in Overall Safety Summary of Adverse Events (TEAE)|Number of participants with adverse events (AEs) collected from Day 1 (post plerixafor administration) to Day 3. AEs were graded by the investigator using the World Health Organization (WHO) Adverse Event Grading Scale and were assessed for severity (mild, moderate, severe, life-threatening) and relatedness to study treatment (5 point scale from 'not related' to 'definitely related').|up to Day 3|The safety analyses were performed on the Safety Population which consisted of all subjects who received plerixafor.||participants|||Number
738047|NCT00445302|Primary|Dose-Normalized Area Under the Plerixafor Concentration Time Curve From Time 0 to 24 Hours Post-dose (AUC0-24h)|Evaluation of AUC0-24 hour following a single dose of 240 µg/kg plerixafor administered on Day 1. AUC0-24 was normalized by dose.|Pre-dose of plerixafor to 24 hours post-plerixafor|Intent-to-treat population||hr*ng/mL/ug||Standard Deviation|Mean
738048|NCT00445302|Secondary|Change From Baseline in Absolute White Blood Cell (WBC) Counts at Day 2|Change in absolute white blood cells from baseline to Day 2 (24 hours post-plerixafor) following a single dose of plerixafor. Change from baseline = absolute white blood cells at 24 hours post dose - absolute white blood cells at Baseline.|Baseline and Day 2|An intent-to-treat approach was used to calculate the outcome measure in each arm/group.||cells/mm^3||Standard Deviation|Mean
738049|NCT00445302|Secondary|Change From Baseline in Absolute CD34+ Cell Counts at Day 2|Change in circulating CD34+ cells from baseline to Day 2 (24 hours post-plerixafor) following a single dose of plerixafor. Change from baseline = CD34+ cell count at 24 hours post dose - CD34+ cell count at Baseline.|Baseline, Day 2|An intent-to-treat approach was used to calculate the outcome measure in each arm/group.||cells/mm^3||Standard Deviation|Mean
738050|NCT00445302|Primary|Dose-Normalized Maximum Concentration of Plerixafor (Cmax)|Evaluation of Cmax following a single dose of 240 µg/kg plerixafor administered on Day 1. Cmax was normalized by dose.|Pre-dose of plerixafor to 24 hours post-plerixafor|Intent-to-treat population||ng/mL/ug||Standard Deviation|Mean
738051|NCT00445315|Secondary|Number of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Variants Resistant to PF-00868554||Screening up to Day 8|FAS included all randomized participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||participants|||Number
738052|NCT00445315|Secondary|Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Viral Load at Day 8|HCV RNA levels were determined using the Abbott RealTime HCV polymerase chain reaction (PCR) assay (lower limit of detection [LOD] = 12 international unit per milliliter [IU/mL]). Baseline value calculated as the average of the screening Day 0 and Day 1 pre-dose measurements. The plasma HCV RNA data was log10 transformed, and the change in log10 HCV RNA at Day 8 post-dose from baseline was calculated.|Baseline, Day 8|Full analysis set (FAS) included all randomized participants who received at least 1 dose of study medication.||log10 copies/mL||Standard Deviation|Mean
738053|NCT00445315|Primary|Day 8 to Day 1 Ratio of the 6 Beta-Hydroxyl Cortisol to Cortisol Ratios|Urine 6 beta-hydroxyl cortisol and cortisol concentrations were measured using high performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS).|-24 to 0 hours (pre-dose) on Day 1 (Day 0); 0 to 24 hours post-dose on Day 8|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters.||ratio||Standard Deviation|Geometric Mean
738055|NCT00445315|Primary|Ratio of 6 Beta-Hydroxyl Cortisol to Cortisol: Day 1|Urine 6 beta-hydroxyl cortisol and cortisol concentrations were measured using high performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS).|-24 to 0 hours (pre-dose) on Day 1 (Day 0)|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters.||ratio||Standard Deviation|Geometric Mean
738056|NCT00445315|Primary|Renal Clearance (CLr): Day 8|Renal clearance was calculated as cumulative amount of drug recovered unchanged in urine during the dosing interval (Ae) divided by area under the plasma concentration time-curve from time zero to end of dosing interval (AUCtau), where dosing interval is 12 hours.|0 to 12 hours, 12 to 24 hours post-dose|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters. Urine collection interval was 12 hours and not 8 hours; therefore, urinary PK parameters were not calculated for three times daily regimens.||mL/minute||Standard Deviation|Geometric Mean
738057|NCT00445315|Primary|Renal Clearance (CLr): Day 1|Renal clearance was calculated as cumulative amount of drug recovered unchanged in urine during the dosing interval (Ae) divided by area under the plasma concentration time-curve from time zero to end of dosing interval (AUCtau), where dosing interval is 12 hours.|0 to 12 hours, 12 to 24 hours post-dose|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters. Urine collection interval was 12 hours and not 8 hours; therefore, urinary PK parameters were not calculated for three times daily regimens.||mL/minute||Standard Deviation|Geometric Mean
738058|NCT00445315|Primary|Percent of Dose Recovered Unchanged in Urine (Ae%): Day 8|Percent of dose recovered unchanged in urine during the dosing interval=100 (cumulative amount of drug recovered unchanged in urine [Ae] divided by dose), where the dosing interval is 12 hours.|0 to 12 hours, 12 to 24 hours post-dose|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters. Urine collection interval was 12 hours and not 8 hours; therefore, urinary PK parameters were not calculated for three times daily regimens.||percent dose recovered||Standard Deviation|Geometric Mean
738059|NCT00445315|Primary|Percent of Dose Recovered Unchanged in Urine (Ae%): Day 1|Percent of dose recovered unchanged in urine during the dosing interval=100*(cumulative amount of drug recovered unchanged in urine [Ae] divided by dose), where the dosing interval is 12 hours.|0 to 12 hours, 12 to 24 hours post-dose|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters. Urine collection interval was 12 hours and not 8 hours; therefore, urinary PK parameters were not calculated for three times daily regimens.||percent dose recovered||Standard Deviation|Geometric Mean
738060|NCT00445315|Primary|Cumulative Amount of Drug Recovered Unchanged in Urine (Ae): Day 8|Ae is the cumulative amount of drug recovered unchanged in urine during the dosing interval, where the dosing interval is 12 hours. Cumulative amount was calculated as sum of urine drug concentration in sample volume for each collection interval. Sample volume = (urine weight in gram [g]/1.020), where 1.020 g/mL is the approximate specific gravity of urine.|0 to 12 hours, 12 to 24 hours post-dose|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters. Urine collection interval was 12 hours and not 8 hours; therefore, urinary PK parameters were not calculated for three times daily regimens.||nanogram||Standard Deviation|Geometric Mean
738061|NCT00445315|Primary|Cumulative Amount of Drug Recovered Unchanged in Urine (Ae): Day 1|Ae is the cumulative amount of drug recovered unchanged in urine during the dosing interval, where the dosing interval is 12 hours. Cumulative amount was calculated as sum of urine drug concentration in sample volume for each collection interval. Sample volume = (urine weight in gram [g]/1.020), where 1.020 g/mL is the approximate specific gravity of urine.|0 to 12 hours, 12 to 24 hours post-dose|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters. Urine collection interval was 12 hours and not 8 hours; therefore, urinary PK parameters were not calculated for three times daily regimens.||nanogram||Standard Deviation|Geometric Mean
738062|NCT00445315|Primary|Observed Accumulation Ratio for Cmax (Rac Cmax)|Rac Cmax was calculated as, maximum observed plasma concentration on Day 8 (Cmax) divided by maximum observed plasma concentration on Day 1(Cmax).|0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose on Day 1; 0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 hours post-dose on Day 8|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters.||ratio||Standard Deviation|Geometric Mean
738063|NCT00445315|Primary|Observed Accumulation Ratio (Rac)|Rac was calculated as, area under the curve from time zero to end of dosing interval on Day 8 (AUCtau) divided by area under the curve from time zero to end of dosing interval on Day 1(AUCtau).|0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose on Day 1; 0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 hours post-dose on Day 8|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters.||ratio||Standard Deviation|Geometric Mean
738064|NCT00445315|Primary|Plasma Decay Half-Life (t1/2): Day 8|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. The t1/2 of PF-04691502 was assessed following repeated oral dose administration for 8 days (multiple dose PK).|0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 hours post-dose on Day 8|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||hour||Standard Deviation|Mean
738065|NCT00445315|Primary|Minimum Observed Plasma Trough Concentration (Cmin): Day 8|The Cmin of PF-04691502 was assessed following repeated oral dose administration for 8 days (multiple dose PK).|0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 hours post-dose on Day 8|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters.||ng/mL||Standard Deviation|Geometric Mean
738582|NCT00450580|Secondary|Percentage of Participants With HIV-1 RNA <50 and >=50 Copies/mL by Visit Over 48 Weeks|A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at week 48. The percentage of participants with HIV-1 RNA <50 copies/mL at Week 48 was determined by the TLOVR algorithm|Week 48|ITT-E Population||Percentage of participants|||Number
738066|NCT00445315|Primary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau): Day 8|Area under the plasma concentration time-curve from time zero to end of dosing interval (tau), where dosing interval is 8 hours for three times daily regimens and 12 hours for the twice daily regimens.|0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 hours post-dose|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters.||ng*hour/mL||Standard Deviation|Geometric Mean
738067|NCT00445315|Primary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau): Day 1|Area under the plasma concentration time-curve from time zero to end of dosing interval (tau), where dosing interval is 8 hours for three times daily regimens and 12 hours for the twice daily regimens.|0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose for twice daily dose; 0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8 hours post-dose for three times daily dose|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters.||ng*hour/mL||Standard Deviation|Geometric Mean
738068|NCT00445315|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax): Day 8||0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 hours post-dose|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters.||hour||Full Range|Median
738069|NCT00445315|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax): Day 1||0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose for twice daily dose; 0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8 hours post-dose for three times daily dose|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters.||hour||Full Range|Median
738070|NCT00445315|Primary|Maximum Observed Plasma Concentration (Cmax): Day 8||0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 hours post-dose|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters.||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
738071|NCT00445315|Primary|Maximum Observed Plasma Concentration (Cmax): Day 1||0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose for twice daily dose; 0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8 hours post-dose for three times daily dose|Per Protocol (PP) analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the pharmacokinetics (PK) parameters.||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
738072|NCT00445328|Secondary|Thrombocytopenia|Subjects with thrombocytopenia (low platelets).|Day 21|Intent to Treat (ITT)||participants|||Number
738073|NCT00445328|Primary|Composite of Objectively Verified Thromboembolic Events|Subjects with objectively verified thromboembolic events: symptomatic proximal and distal deep vein thrombosis [DVT], asymptomatic proximal DVT, fatal or symptomatic non-fatal pulmonary embolism [PE] or sudden death within 24 hours of onset of venous thromboembolism (VTE) symptoms. Occurrence of any ='Present', otherwise = 'Absent'.|Day 21|Intent to treat (ITT)||participants|||Number
738074|NCT00445328|Secondary|Allergic Reactions (Drug-related)|Subjects with drug-related allergic reactions|Day 21|Intent to treat (ITT)||participants|||Number
738075|NCT00445328|Secondary|Bleeding - Major or Minor|Subjects with bleeding. Bleeding classified as major if it is: intraocular, spinal/epidural, intracranial or retroperitoneal; or if hemoglobin decreased by ≥ 2 g/dl(grams/deciliter); or if transfusion of ≥ 2 Units of blood or if significant medical or surgical intervention was required; or if it results in death. All other bleeding is classified as minor.|Day 21|Intent to treat (ITT)||participants|||Number
738076|NCT00445328|Secondary|Stroke - Ischemic or Hemorrhagic|Subjects with stroke (either ischemic or hemorrhagic) based on results of CT (computed tomographic) pulmonary angiography|Day 21|Intent to treat (ITT)||participants|||Number
738077|NCT00445328|Secondary|All Cause Mortality|Subjects with death from any cause: end of study.|Day 14, Day 21 (End of Study)|Intent to treat (ITT)||participants|||Number
738078|NCT00445328|Primary|Confirmed Thromboembolic Events|Confirmed thromboembolic events = 'present' if any following events are present/abnormal, otherwise = 'absent': Deep vein thrombosis measured by Color Doppler ultrasonography lower limbs; pulmonary embolism by chest xray, ventilation-perfusion scan, computed tomography pulmonary angiography; Sudden Death within 24 hours of venous thromboembolism symptoms.|Day 21|Intent to treat (ITT) set: all subjects who were randomized, received at least 1 dose of study drug and had undergone at least 1 test of primary efficacy assessment.||participants|||Number
738079|NCT00445341|Primary|Response Rate (Complete Response (CR) and Partial Response (PR))|Response was assessed by the Cheson criteria. Complete response is complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease related symptoms if present before therapy, and normalization of those biochemical abnormalities (e.g.(LDH) definitely assignable to the lymphoma. All lymph nodes must have regressed to normal size (</= 1.5 cm in greatest diameter if > 1.5 cm before therapy). Previously involved nodes that were 1.1 to 1.5 cm in greatest diameter must have decreased to </= 1 cm or by more than 75% in the sum of the products of the greatest diameters (SPD). Spleen, if considered to be enlarged before therapy, must have regressed in size. Partial response is a >/= 50% decrease in the SPD of 6 largest dominant nodes or nodal masses. No increase in size of nodes, liver or spleen and no new sites of disease. Splenic and hepatic nodules must regress by >/= 50% in the SPD. Bone marrow is irrelevant for determination of a PR.|2/16/2007 - 1/20/2011|||Participants|||Number
738080|NCT00445341|Primary|Number of Participants With Adverse Events (e.g. Toxicity)|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|47 months|||Participants|||Number
738081|NCT00445432|Other Pre-specified|Change in Mental Component of the Short Form-36 Health Survey From Baseline of the Lead-in Study (NCT00445939) to Week 148|The Short Form-36 (SF-36) Health Survey is a comprehensive quality of life scale. An increase in SF-36 indicates alleviation of the disease and a decrease in score indicates aggravation. The mental component reflects energy/vitality, social functioning, limitations, and ratings of one's mental health. Score on mental component ranges from 0 (worst score) to 100 (best score).|Baseline of lead-in study (NCT00445939) to Week 148 relative to the first dose of adalimumab in NCT00445432 (Study M06-837)|Data is reported as observed cases. No imputation technique was used.||units on a scale||Standard Deviation|Mean
738082|NCT00445432|Other Pre-specified|Change in Physical Component of the Short Form-36 Health Survey From Baseline of the Lead-in Study (NCT00445939) to Week 148|The Short Form-36 (SF-36) Health Survey is a comprehensive quality of life scale. An increase in SF-36 score indicates alleviation of the disease and a decrease in score indicates aggravation of disease. The physical component reflects activity level, activity limitations, pain, and rating of one's health. Score on the physical component ranges from 0 to 100, with 0=Poorest Health and 100=Best Health.|Baseline of lead-in study (NCT00445939) to Week 148 relative to the first dose of adalimumab in NCT00445432 (Study M06-837)|Data is reported as observed cases. No imputation technique was used.||units on a scale||Standard Deviation|Mean
738083|NCT00445432|Other Pre-specified|Change in Inflammatory Bowel Disease Questionnaire (IBDQ) From Baseline of Lead-in Study (NCT00445939) to Week 148|"IBDQ is a validated disease-specific instrument that assesses the impact of IBD on patient quality of life during a 2-week recall period with 32 questions about bowel function and related symptoms & their social/emotional impact. Per item, participants select 1 of 7 responses (1=poor quality of life [e.g., feeling of fatigue all of the time]; 7=good quality [e.g., feeling of fatigue none of the time]). Scoring range=32 to 224. Higher scores indicate better quality of life; increases in IBDQ=improved overall quality of life."|Baseline of lead-in study (NCT00445939) to Week 148 relative to the first dose of adalimumab in NCT00445432 (Study M06-837)|Data is reported as observed cases. No imputation technique was used.||units on a scale||Standard Deviation|Mean
738084|NCT00445432|Other Pre-specified|Change in International Organization for the Study of Inflammatory Bowel Disease (IOIBD) Score From Baseline of Lead-in Study (NCT00445939) to Week 148|The International Organization for the Study of Inflammatory Bowel Disease (IOIBD) score is an indicator of the activity of Crohn's disease. It measures absence (score of 0) or presence (score of 1) of abdominal pain, diarrhea or bloody stools more than 6 times per day, anal lesion, anal fistula, other complication, abdominal mass, weight loss, fever above 38 degrees Centigrade, abdominal tenderness, and blood pigment below 10 g/dL. Total possible score=0 to 10; low score=less disease activity. Decrease in score indicates alleviation of the disease; increase indicates aggravation of disease.|Baseline of lead-in study (NCT00445939) to Week 148 relative to the first dose of adalimumab in NCT00445432 (Study M06-837)|Data is reported as observed cases. No imputation technique was used.||units on a scale||Standard Deviation|Mean
738085|NCT00445432|Other Pre-specified|Change in Crohn's Disease Activity Index From Baseline of Lead-in Study (NCT00445939) to Week 148|Crohn's Disease Activity Index (CDAI) is a measure of disease severity. Number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/apthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss are documented during 1-week assessment period. CDAI has a total score >=0 and without upper limit. Low score=less severe CD activity. Decrease in score indicates improvement.|Baseline of lead-in study (NCT00445939) to Week 148 relative to the first dose of adalimumab in NCT00445432 (Study M06-837)|Data is reported as observed cases. No imputation technique was used.||units on a scale||Standard Deviation|Mean
738086|NCT00445432|Other Pre-specified|Number of Participants Who Had Clinical Response-100 (CR-100; a Decrease in Crohn's Disease Activity Index of at Least 100 Points From Lead-in Study [NCT00445939] Baseline Score) at Week 148|Crohn's Disease Activity Index (CDAI) documents number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss during a 1-week assessment period. CDAI has a total score >= 0 and without upper limit. Low score=less severe CD activity. Decrease in score indicates improvement.|Week 148 relative to the first dose of adalimumab in NCT00445432 (Study M06-837)|Data is reported as observed cases. No imputation technique was used.||participants|||Number
738087|NCT00445432|Other Pre-specified|Number of Participants Who Had Clinical Response-70 (CR-70; a Decrease in Crohn's Disease Activity Index of at Least 70 Points From Lead-in Study [NCT00445939] Baseline Score) at Week 148|Crohn's Disease Activity Index (CDAI) documents number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss during a 1-week assessment period. CDAI has a total score >= 0 and without upper limit. Low score=less severe CD activity. Decrease in score indicates improvement.|Week 148 relative to the first dose of adalimumab in NCT00445432 (Study M06-837)|Data is reported as observed cases. No imputation technique was used.||participants|||Number
738088|NCT00445432|Other Pre-specified|Number of Participants Who Had Clinical Remission at Week 148|Clinical remission = Crohn's Disease (CD) Activity Index (CDAI) <150; number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss are documented during 1-week assessment period. CDAI total score is >= 0 and without upper limit. Low score=less severe CD activity. Decrease indicates improvement.|Week 148 relative to the first dose of adalimumab in NCT00445432 (Study M06-837)|Data is reported as observed cases. No imputation technique was used.||participants|||Number
738089|NCT00445432|Secondary|Change in Mental Component of the Short Form-36 Health Survey From Baseline of the Lead-in Study (NCT00445939) to Week 52 of Double-blind Treatment|The Short-Form-36 (SF-36) Health Survey is a comprehensive quality of life scale. An increase in SF-36 score indicates alleviation of the disease and a decrease in score indicates aggravation. The mental component reflects energy/vitality, social functioning, limitations, and ratings of one's mental health. Score on mental component ranges from 0 (worst score) to 100 (best score).|Baseline of lead-in study (NCT00445939) to Week 52 of double-blind treatment|Modified Full Analysis Set (mFAS), defined as participants who had received adalimumab (not placebo) during the adalimumab induction study and who received at least 1 dose of DB study drug during this study. Last observation carried forward (LOCF) used for missing data.||units on a scale||Standard Deviation|Mean
738090|NCT00445432|Secondary|Change in Physical Component of the Short Form-36 Health Survey From Baseline of the Lead-in Study (NCT00445939) to Week 52 of Double-blind Treatment|The Short-Form-36 (SF-36) Health Survey is a comprehensive quality of life scale. An increase in SF-36 score indicates alleviation of the disease and a decrease in score indicates aggravation of disease. The physical component reflects activity level, activity limitations, pain, and rating of one's health. Score on the physical component ranges from 0 (Poorest Health) to 100 (Best Health).|Baseline of lead-in study (NCT00445939) to Week 52 of double-blind treatment|Modified Full Analysis Set (mFAS), defined as participants who had received adalimumab (not placebo) during the adalimumab induction study and who received at least 1 dose of DB study drug during this study. Last observation carried forward (LOCF) used for missing data.||units on a scale||Standard Deviation|Mean
738091|NCT00445432|Secondary|Change in Inflammatory Bowel Disease Questionnaire (IBDQ) From Baseline of Lead-in Study (NCT00445939) to Week 52 of Double-blind Treatment|"IBDQ is a validated disease−specific instrument that assesses the impact of IBD on patient quality of life during a 2−week recall period. It has 32 questions about bowel function and related symptoms, and their social and emotional impact. For each item, participants select 1 of 7 responses. 1=poor quality of life (e.g., feeling of fatigue all of the time) and 7=good quality (e.g., feeling of fatigue none of the time). Scoring range = 32 to 224. Higher scores indicate better quality of life; increases in IBDQ = improved overall quality of life."|Baseline of lead-in study (NCT00445939) to Week 52 of double-blind treatment|Modified Full Analysis Set (mFAS), defined as participants who had received adalimumab (not placebo) during the adalimumab induction study and who received at least 1 dose of DB study drug during this study. Last observation carried forward (LOCF) used for missing data.||units on a scale||Standard Deviation|Mean
738092|NCT00445432|Secondary|Change in International Organization for the Study of Inflammatory Bowel Disease (IOIBD) Score From Baseline of Lead-in Study (NCT00445939) to Week 52 of Double-blind Treatment|The International Organization for the Study of Inflammatory Bowel Disease (IOIBD) score is an indicator of the activity of Crohn's disease. It measures absence (score of 0) or presence (score of 1) of abdominal pain, diarrhea or bloody stools more than 6 times per day, anal lesion, anal fistula, other complication, abdominal mass, weight loss, fever above 38 degrees Centigrade, abdominal tenderness, and blood pigment below 10 g/dL. Total possible score=0 to 10; low score=less disease activity. Decrease in score indicates alleviation of the disease; increase indicates aggravation of disease.|Baseline of lead-in study (NCT00445939) to Week 52 of double-blind treatment|Modified Full Analysis Set (mFAS), defined as participants who had received adalimumab (not placebo) during the adalimumab induction study and who received at least 1 dose of DB study drug during this study. Last observation carried forward (LOCF) used for missing data.||units on a scale||Standard Deviation|Mean
738093|NCT00445432|Secondary|Number of Participants Who Had Clinical Remission at Week 52 of Open-label Treatment|Clinical remission=Crohn's Disease (CD) Activity Index (CDAI) <150; number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss are documented during 1-week assessment period. CDAI total score is >= 0 and without upper limit. Low score=less severe CD activity. Decrease in score indicates improvement.|Week 52 of open-label treatment|OL efficacy set (assigned to OL treatment at Week 0, received >= 1 dose of OL study drug). Last observation carried forward (LOCF) used for missing data.||Participants|||Number
738094|NCT00445432|Secondary|Change in Crohn's Disease Activity Index From Baseline of Lead-in Study (NCT00445939) to Week 52 of Double-blind Treatment|Crohn's Disease Activity Index (CDAI) is a measure of disease severity. Number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss are documented during 1-week assessment period. CDAI has a total score >= 0 and without upper limit. Low score=less severe CD activity. Decrease in score indicates improvement.|Baseline of lead-in study (NCT00445939) to Week 52 of double-blind treatment|modified Full Analysis Set (mFAS), defined as participants who had received adalimumab (not placebo) during the adalimumab induction study and who received at least 1 dose of DB study drug during this study. Last observation carried forward (LOCF) used for missing data.||units on a scale||Standard Deviation|Mean
738095|NCT00445432|Secondary|Number of Participants Who Had Clinical Response-100 (CR-100; a Decrease in Crohn's Disease Activity Index of at Least 100 Points From Lead-in Study [NCT00445939] Baseline Score) at Week 52 of Double-blind Treatment|Crohn's Disease Activity Index (CDAI) documents number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss during a 1-week assessment period. CDAI has a total score >= 0 and without upper limit. Low score=less severe CD activity. Decrease in score indicates improvement.|Week 52 of double-blind treatment|OL efficacy set (assigned to OL treatment at Week 0, received >= 1 dose of OL study drug) and mFAS (participants who had received adalimumab (not placebo) during adalimumab induction study and who received >= 1 dose of DB study drug during this study). NRI (CR-100 not achieved) used for missing data for DB treatments; LOCF for OL treatment.||Participants|||Number
738096|NCT00445432|Secondary|Number of Participants Who Had Clinical Response-70 (CR-70; a Decrease in Crohn's Disease Activity Index of at Least 70 Points From Lead-in Study [NCT00445939] Baseline Score) at Week 52 of Double-blind Treatment|Crohn's Disease Activity Index (CDAI) documents number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss during a 1-week assessment period. CDAI has a total score >= 0 and without upper limit. Low score=less severe CD activity. Decrease in score indicates improvement.|Week 52 of double-blind treatment|OL efficacy set (assigned to OL treatment at Week 0, received >= 1 dose of OL study drug) and mFAS (participants who had received adalimumab [not placebo] during adalimumab induction study and who received >= 1 dose of DB study drug during this study). Nonresponder imputation (NRI) (CR-70 not achieved) used for DB treatments; LOCF for OL treatment.||Participants|||Number
738097|NCT00445432|Primary|Number of Participants Who Had Clinical Remission at Week 52 of Double-blind Treatment|Clinical remission=Crohn's Disease (CD) Activity Index (CDAI) <150; number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss are documented during 1-week assessment period. CDAI total score is >= 0 and without upper limit. Low score=less severe CD activity. Decrease indicates improvement.|Week 52 of double-blind treatment|Modified Full Analysis Set (mFAS), defined as participants who had received adalimumab (not placebo) during the adalimumab induction study and who received at least 1 dose of DB study drug during this study. Nonresponder imputation (NRI) (clinical remission not achieved) was used for missing data.||Participants|||Number
738098|NCT00445484|Primary|23F Antibody Response to Prevnar Vaccine in Peripheral Blood|Serum IgG levels against the PVC serotype were measured by ELISA|basline and 8 weeks after second vaccination|Patients who showed evidence of disease progression while on study were not included in the analysis.||fold change||Standard Error|Mean
738099|NCT00445484|Primary|19F Antibody Response to Prevnar Vaccine in Peripheral Blood|Serum IgG levels against the PVC serotype were measured by ELISA|basline and 8 weeks after second vaccination|Patients who showed evidence of disease progression while on study were not included in the analysis.||fold change||Standard Error|Mean
738100|NCT00445484|Primary|14F Antibody Response to Prevnar Vaccine in Peripheral Blood|Serum IgG levels against the PVC serotype were measured by ELISA|basline and 8 weeks after second vaccination|Patients who showed evidence of disease progression while on study were not included in the analysis.||fold change||Standard Error|Mean
738101|NCT00445484|Primary|6B Antibody Response to Prevnar Vaccine in Peripheral Blood|Serum IgG levels against the PVC serotype were measured by ELISA|basline and 8 weeks after second vaccination|Patients who showed evidence of disease progression while on study were not included in the analysis.||fold change||Standard Error|Mean
738102|NCT00445549|Secondary|The Number of Participants With Adverse Events|Here are the total # of participants with adverse events. For the detailed list of adverse events, see the adverse event module.|22 months|||Participants|||Number
738103|NCT00445549|Primary|Number of Participants With Clinical Efficacy|Defined as complete response (CR), partial response (PR), or disease stabilization lasting 6 months or longer per RECIST criteria. CR-total disappearance of all evaluable disease. PR->30% reduction in the sum of the longest diameters (LD) of target lesions. Stable disease (SD) is <30% decrease and <20% increase in the sum of the LD of all target lesions. See the protocol Link module for full RECIST criteria.|24 weeks|||participants|||Number
738104|NCT00445588|Secondary|6months -Progression-free Survival Rate|defined patient started treatment is alive and progression free at the time of 26-week (6 months) follow-up|At 6 months- defined as patient started treatment is alive and progression free at the time of 26-week (6 months) follow-up|||percentage of participants||95% Confidence Interval|Number
738105|NCT00445588|Primary|Overall Survival|death. measured by time of first day of treatment until date of death, assessed up to 2 years.|Time of first day of the treatment to death, assessed up to 2 years|||months||95% Confidence Interval|Median
738106|NCT00445679|Secondary|Covi Anxiety Scale Score Mean Change From Baseline|Covi anxiety scale measures the severity of anxiety symptoms on 3 items: verbal report, behavior and somatic complaints. Each dimension is assessed using a 5-point scale: 1 = not at all, 2 = somewhat, 3 = moderately, 4 = considerably, 5 = Very much. Total score ranges from 3 to 15; higher score indicates more anxiety.|8 weeks|The intent-to-treat (ITT) population included all subjects randomly assigned to treatment who had a baseline HAM-D17 evaluation, took at least 1 dose of double-blind test article, and had at least 1 postbaseline HAM-D17 evaluation. Number of participants analyzed reflects the final on-therapy population.||scores on a scale||95% Confidence Interval|Mean
738107|NCT00445679|Secondary|Hamilton Rating Scale for Depression, 6-item (HAM-D6) Score Mean Change From Baseline|HAM-D6: standardized, clinician-administered rating scale is a subset of the HAM-D17 that assesses 6 items associated with major depression. The scale uses HAM-D17 items 1, 2, 7, 8, 10 and 13. Item 13 is scored 0 to 2 (0=none/absent to 2=most severe) and all others are scored 0 to 4 (0=none/absent to 4=most severe). Total score ranges from 0 to 22; higher score indicates more depression.|8 weeks|The intent-to-treat (ITT) population included all subjects randomly assigned to treatment who had a baseline HAM-D17 evaluation, took at least 1 dose of double-blind test article, and had at least 1 postbaseline HAM-D17 evaluation. Number of participants analyzed reflects the final on-therapy population.||scores on a scale||95% Confidence Interval|Mean
738108|NCT00445679|Secondary|Visual Analog Scale-pain Intensity (VAS-PI) Score Mean Change From Baseline|The VAS-PI is a self-rated visual analog scale for the assessment of pain. Scores on the VAS-PI range from 0 (no pain) to 10 (worst possible pain). A decrease in VAS-PI overall scores indicates a subject’s assessment of an improvement in pain.|8 weeks|The intent-to-treat (ITT) population included all subjects randomly assigned to treatment who had a baseline HAM-D17 evaluation, took at least 1 dose of double-blind test article, and had at least 1 postbaseline HAM-D17 evaluation. Number of participants analyzed reflects the final on-therapy population.||scores on a scale||95% Confidence Interval|Mean
738109|NCT00445679|Secondary|Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Mean Change From Baseline|Measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline and 8 weeks|The intent-to-treat (ITT) population included all subjects randomly assigned to treatment who had a baseline HAM-D17 evaluation, took at least 1 dose of double-blind test article, and had at least 1 postbaseline HAM-D17 evaluation. Number of participants analyzed reflects the final on-therapy population.||units on a scale||95% Confidence Interval|Mean
738110|NCT00445679|Secondary|Clinical Global Impressions Scale–Severity of Illness (CGI-S) Scores|CGI-S is a global rating scale that measures the severity of a subject’s disease. Using a 7-point scale, the clinician rates the severity of the patient’s mental illness at the time of the assessment, relative to the clinician’s experience with subjects who have the same diagnosis (1= normal, not at all ill; 7= among the most extremely ill).|8 weeks|The intent-to-treat (ITT) population included all subjects randomly assigned to treatment who had a baseline HAM-D17 evaluation, took at least 1 dose of double-blind test article, and had at least 1 postbaseline HAM-D17 evaluation. Number of participants analyzed reflects the final on-therapy population.||subjects|||Number
738111|NCT00445679|Secondary|Clinical Global Impressions Scale–Improvement (CGI-I) Scores|CGI-I is a global rating scale that measures disease improvement. Using a 7-point scale, the clinician rates how much the subject's illness has improved or worsened relative to the baseline status (1= very much improved; 7= very much worse).|8 weeks|The intent-to-treat (ITT) population included all subjects randomly assigned to treatment who had a baseline HAM-D17 evaluation, took at least 1 dose of double-blind test article, and had at least 1 postbaseline HAM-D17 evaluation. Number of participants analyzed reflects the final on-therapy population.||subjects|||Number
738112|NCT00445679|Primary|Percentage of Responders With a 50% or Greater Decrease From Baseline on the Hamilton Rating Scale for Depression, 17-item (HAM-D17)|HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe, for a maximum total score of 50.|8 weeks|The intent-to-treat (ITT) population included all subjects randomly assigned to treatment who had a baseline HAM-D17 evaluation, took at least 1 dose of double-blind test article, and had at least 1 postbaseline HAM-D17 evaluation.||percentage of responders|||Number
738113|NCT00445705|Secondary|Patient Global Impression of Change (PGIC) for Fibromyalgia Syndrome Status at Week 4|PGIC status for fibromyalgia syndrome at week 4. The PGIC consists of a self-evaluation by the patient of the overall change of their fibromyalgia syndrome since the beginning of the study, rated on a 7-point scale (score of 1-3 = very much improved to minimally improved; 4= no change; 5-7 = minimally worse to very much worse). Results are presented for the percentage of patients reporting each status: “improved”= score of 1-3; “no change”=score of 4; and “worse”=score of 5-7.|Week 4|Modified Intent-To-Treat (m-ITT). The m-ITT population included all randomized patients who started study (randomized) and who received the study medication with at least one post-treatment mean daily-average-pain score.||Percentage of Patients|||Number
738114|NCT00445705|Secondary|Change From Baseline in the Fibromyalgia Impact Questionnaire (FIQ) Total Score of Physical Impairment at Week 4|Change from baseline in FIQ total score of physical impairment at week 4. The FIQ is a disease-specific questionnaire consisting of 10 questions and visual analog scales regarding functional disability, pain intensity, sleep function, stiffness, anxiety, depression, and overall sense of wellbeing. Each question is scored from 0 to 10 with 0 = no impairment (best) and 10 indicates maximum impairment (worst), for a minimum possible score (best) of 0 and a maximum possible (worst) total score of 100. A negative number change from baseline indicates improvement.|Baseline, Week 4|Modified Intent-To-Treat (m-ITT). The m-ITT population included all patients who started the study (randomized) and received study medication with at least one post-treatment mean daily-average-pain score.||Scores on a Scale||Standard Deviation|Mean
738115|NCT00445705|Secondary|Change From Baseline in the Short Form Brief Pain Inventory (SF-BPI) Average Pain Score at Week 4|Change from baseline in the SF-BPI average pain question score at week 4. The SF-BPI is a patient-rated questionnaire that assesses certain aspects of pain including location, intensity, and interference with certain daily activities. The “average pain” question was rated on an 11-point scale (where 0=no pain and 10=worst pain imaginable). A negative number change from baseline indicates a reduction in average pain.|Baseline, Week 4|Modified Intent-To-Treat (m-ITT). The m-ITT population included all patients who started the study (randomized) and received study medication with at least one post-treatment mean daily-average-pain score.||Scores on a Scale||Standard Deviation|Mean
738116|NCT00445705|Primary|Change From Baseline in Mean Daily-Average-Pain Score at Week 4|Change from Baseline in mean daily-average-pain score at week 4. Patients recorded their daily average pain on a 11-point scale (where 0 equals no pain and 10 equals worst pain imaginable) using a diary during the 4-week treatment period. A negative number change from baseline represents a decrease in average pain (improvement).|Baseline, Week 4|Modified Intent-To-Treat (m-ITT). The m-ITT population included all patients who started the study (randomized) and received study medication with at least one post-treatment mean daily-average-pain score.||Scores on a Scale||Standard Deviation|Mean
738117|NCT00445770|Other Pre-specified|Comparison of Etanercept Serum Concentrations Between the 10 mg and 25 mg Etanercept Doses||Weeks 12, 24, 52|mITT; n = evaluable participants at the specified time point.||nanograms per milliliter (ng/mL)||Standard Error|Mean
738118|NCT00445770|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|ESR: laboratory test that provided a non-specific measure of inflammation. The test assessed the rate at which red blood cells fell in a test tube and was measured in mm/hour. Normal range: 0-30mm/h. Higher rate consistent with inflammation.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|mITT; LOCF||mm/hr||Standard Deviation|Mean
738119|NCT00445770|Secondary|Change From Baseline in C-reactive Protein (CRP) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|CRP: marker of inflammation. Higher level consistent with inflammation. Normal CRP range: 0 to 1.0 milligrams per deciliter (mg/dL).|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|mITT; LOCF||mg/dL||Standard Deviation|Mean
738120|NCT00445770|Secondary|Change From Baseline in Disease Activity Score in 28 Joints (DAS28) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|DAS based on 28 painful joint counts, 28 swollen joint counts, ESR, and GH. DAS28 score calculated as 0.56 √ (28 painful joint count) + 0.28 √ (28 swollen joint count) + 0.70 (ln ESR mm/hr) + 0.014 GH. Change from baseline = DAS at Week x minus Baseline DAS. Total DAS scores could range from 10 (worse outcome) to 0 (better outcome).|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|mITT; LOCF||Scores on a scale||Standard Deviation|Mean
738121|NCT00445770|Secondary|Change From Baseline in Disease Activity Score (DAS) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|DAS: weighted calculation of joint tenderness score (Ritchie Articular Index[RAI]), swollen joint count of 44 joints, natural logarithm (ln) of erythrocyte sedimentation rate (ESR) in millimeters per hour (mm/hr), and general health (GH) using VAS. RAI defined as sum of 26 possible 0 to 3 tender scores. DAS = 0.53938 square root (√) (RAI) + 0.06465 (swollen joint count) + 0.330 (ln ESR) + 0.00722 (GH). Change from baseline = DAS at Week x minus Baseline DAS. Total DAS scores could range from 10 (worse outcome) to 0 (better outcome).|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|mITT; LOCF||Scores on a scale||Standard Deviation|Mean
738146|NCT00445939|Secondary|Clinical Remission (CDAI < 150) at Week 2|Number of subjects in each treatment group in clinical remission (CDAI < 150) in Full Analysis Set (FAS) using non-responder Imputation (NRI) at Week 2.|Week 2|Subjects with a clinical remission (CDAI <= 150) in the adalimumab 160 mg (Week 0/80 mg (Week 2) and adalimumab 80 mg (Week 0)/40 mg (Week 2) in full analysis set using Non-responder Imputation.||Participants|||Number
738122|NCT00445770|Secondary|Percentage of Participants With an ACR70 Response|ACR70 response: ≥ 70% improvement in tender joint count; ≥ 70% improvement in swollen joint count; and ≥ 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|mITT; LOCF||Percentage of participants|||Number
738123|NCT00445770|Secondary|Percentage of Participants With an ACR50 Response|ACR50 response: ≥ 50% improvement in tender joint count; ≥ 50% improvement in swollen joint count; and ≥ 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|mITT; LOCF||Percentage of participants|||Number
738124|NCT00445770|Secondary|Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response|ACR20 response: greater than or equal to (≥) 20 percent (%) improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|mITT; LOCF||Percentage of participants|||Number
738125|NCT00445770|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|HAQ-DI: participant-reported assessment of ability to perform tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) hygiene; and 8) common activities over past week. Each item scored on 4-point Likert scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Change = scores at observation minus score at Baseline and total possible scores ranged from -3 to 3. An increase in score from baseline represented disease progression and/or joint worsening and a decrease represented improvement.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|mITT; LOCF||Scores on a scale||Standard Deviation|Mean
738126|NCT00445770|Secondary|Change From Baseline in VAS for Participant General Health at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|"100mm line (VAS) marked by participant. Participants asked, In general how would you rate your health over the last 2-3 weeks? 0mm=very well to 100mm=extremely bad. Change = scores at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement."|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|mITT; LOCF||mm||Standard Deviation|Mean
738127|NCT00445770|Secondary|Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|100 millimeter (mm) line (VAS) marked by participant. Intensity of pain range (over past week): 0mm = no pain to 100mm = worst possible pain. Change = scores at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|mITT; LOCF||mm||Standard Deviation|Mean
738128|NCT00445770|Secondary|Change From Baseline in Mean Duration of Morning Stiffness at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|Morning stiffness in and around the joints lasting at least 1 hour before maximal improvement. Change = scores at observation minus score at Baseline. An increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|mITT; LOCF||Minutes||Standard Deviation|Mean
738129|NCT00445770|Secondary|Change From Baseline in Patient's Global Assessment at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|Patient's Global Assessment of symptoms, assessed using a 11-point rating scale, where 0=asymptomatic and 10=severe symptoms. Change = scores at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|mITT; LOCF||Scores on a scale||Standard Deviation|Mean
738130|NCT00445770|Secondary|Change From Baseline in Physician's Global Assessment of Symptoms at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|Physician Global Assessment of symptoms, assessed using a 11-point rating scale, where 0=asymptomatic and 10=severe symptoms. Change = scores at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|mITT; LOCF||Scores on a scale||Standard Deviation|Mean
738131|NCT00445770|Secondary|Change From Baseline in Number of Painful Joints on Pressure or on Motion at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|71 joints assessed by the investigator using criteria based on pressure and joint manipulation. Change = scores at observation minus score at Baseline, and total possible scores ranged from -71 to 71. An increase in tender joint count from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|mITT; LOCF||Tender Joints||Standard Deviation|Mean
738132|NCT00445770|Secondary|Change From Baseline in Swollen Joint Count at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|American College of Rheumatology (ACR) swollen joint count was an assessment of 68 joints. Joints classified as either swollen or not swollen. Change = scores at observation minus score at Baseline, and total possible scores ranged from -68 to 68. An increase in swollen joints from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|Modified ITT (mITT) population: participants who received at least 1 dose of the assigned test article; Last Observation Carried Forward (LOCF)||Swollen Joints||Standard Deviation|Mean
738133|NCT00445770|Secondary|Percentage of Participants With no Progression of Joint Destruction at Week 52|Absence of joint destruction defined by 3 categories (mTSS change <=0.5, <=3.0, and <smallest detectable difference [SDD] where SDDs were scores >3.0). mTSS = sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score).|Baseline and Week 52|rITT||Percentage of participants|||Number
738134|NCT00445770|Secondary|Change From Baseline in Joint Space Narrowing (JSN) Score at Weeks 24 and 52|JSN score: severity of JSN in 42 joints (15 per hand and 6 per foot), including subluxation, scored from 0 (no/normal JSN) to 4 (complete loss of joint space, bony ankylosis, or luxation). Maximum JSN score was 168. Change = scores at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Baseline, Week 24, and Week 52|rITT||Scores on a scale||Standard Error|Mean
738135|NCT00445770|Secondary|Change From Baseline in Erosion Score at Weeks 24 and 52|Joint erosion score: erosion severity in 44 joints (16 per hand, 6 per foot). Each joint scored according to surface area involved, from 0 (no erosion) to 5 (extensive bone loss from more than one half of articulating bone). Because each side of foot joint was graded, maximum erosion score for foot joint was 10. Thus, maximum erosion score was 280. Change = score at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Baseline, Week 24, and Week 52|rITT||Scores on a scale||Standard Error|Mean
738136|NCT00445770|Secondary|Change From Baseline in Modified Total Sharp Score (mTSS) at Week 24|mTSS = sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change = scores at observation minus score at Baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represents improvement.|Week 24|rITT||Scores on a scale||Standard Error|Mean
738137|NCT00445770|Primary|Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52|mTSS = sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change = scores at observation minus score at Baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represents improvement.|Week 52|Radiographic intent-to-treat (rITT) population: all participants who received at least 1 dose of the assigned test article and provided radiographic data for baseline and at least 1 post-baseline visit||Scores on a scale||Standard Error|Mean
738138|NCT00445848|Secondary|Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs|Adverse Events (AEs) are reported by CTCAE Version 3.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.|Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.|Eligible patients who had received the protocol treatments were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.||Participants|||Number
738139|NCT00445848|Secondary|Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs|Adverse Events (AEs) are reported by CTCAE Version 3.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.|Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.||||||
738140|NCT00445848|Secondary|Response Rate (Complete and Partial)|Complete Response (CR): Two or more objective statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration. Partial Response (PR): Two or more objective statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration, but not qualifying as CR.|Disease assessment is performed every 6 weeks for 18 weeks, then every 9-12 weeks until progression up to 2 years. After disease progression, patients must be followed every 3 months for 1 year and then every 6 months for a maximum of 3 years.|Only patients with measurable disease at baseline were included in the analysis. 66 of 85 patients (78%) had measurable disease at baseline.||participants|||Number
738141|NCT00445848|Secondary|Progression-free Survival|From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.|Disease assessment is performed every 6 weeks for 18 weeks, then every 9-12 weeks until progression up to 2 years. After disease progression, patients must be followed every 3 months for 1 year and then every 6 months for a maximum of 3 years.|||months||95% Confidence Interval|Median
738142|NCT00445848|Primary|Overall Survival|From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Disease assessment is performed every 6 weeks for 18 weeks, then every 9-12 weeks until progression up to 2 years. After disease progression, patients must be followed every 3 months for 1 year and then every 6 months for a maximum of 3 years.|||months||95% Confidence Interval|Median
738143|NCT00445939|Secondary|Clinical Remission (CDAI <150) at Week 6 and Week 8|The number of subjects with clinical remission (CDAI < 150) in the subjects who were non-responders at Week 4 calculated with non-responder imputation (NRI) at Week 6 and Week 8|Week 6 and Week 8|Subjects who were rated as non-responders (CDAI reduction < 70) in the evaluation of clinical remission (CDAI<150) at Week 4. For Week 6 and Week 8 descriptive statistics performed only for non-responders at Week 4 in the three treatment groups: adalimumab 160/80 mg + 40/40 mg, adalimumab 80/40 mg + 40/40 mg, and placebo + adalimumab 160/80 mg.||Participants|||Number
738144|NCT00445939|Secondary|Clinical Response (CR-70 and CR-100) in Period B|The Number of subjects in each treatment group with a CR-70 (CDAI decrease of >= 70 compared to Baseline) and 100 (CDAI decrease of >= 100 compared to Baseline) in subjects who were non-responders at Week 4 at Week 6 and Week 8.|Week 6 and Week 8|Full analysis set - subjects rated as non-responders (did not attain CDAI reduction >= 70) in the evaluation of CR-70 and CR-100 at Week 4. For Week 6 and Week 8 descriptive statistics performed only for non-responders at Week 4 in the three treatment groups: adalimumab 160/80 mg + 40/40 mg, adalimumab 80/40 mg + 40/40 mg, and placebo + 160/80 mg.||Participants|||Number
738145|NCT00445939|Secondary|Clinical Response (CR-70 and CR-100) in Period A|The number of subjects in each treatment group with a clinical response 70 (CDAI decrease of >=70 compared to Baseline) and 100 (CDAI decrease of >=100 compared to Baseline) at Week 2 and Week 4.|Weeks 2 and Week 4|The secondary efficacy analysis was performed using descriptive statistics in randomized subjects who received at least one dose of study drug (full analysis set) in the three treatment groups: Adalimumab 160 mg/80 mg, adalimumab 80mg/40 mg, and placebo.||participants|||Number
738147|NCT00445939|Primary|The Number of Subjects With a Clinical Remission (Crohn's Disease Activity Index [CDAI] < 150) at Week 4|CDAI is used to quantify the symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score above 450 indicates severe disease. Comparison of the number of subjects with a clinical remission (CDAI < 150) in the adalimumab 160 mg (Week 0)/ 80 mg (Week 2) and adalimumab 80 mg (Week 0)/ 40 mg (Week 2) groups at Week 4.|4 Weeks|The primary analysis will be performed on the full analysis set (randomized subjects who received at least one dose of study drug) using the non-responder imputation for missing remission observations.||Particpants|||Number
738148|NCT00446030|Secondary|Disease-free Survival (DFS) & Overall Survival (OS) of Participants|"DFS is the time from study registration until recurrence of tumor or death from any cause in the absence of previous documentation of tumor recurrence. For participants who are removed from the study follow-up prior to documentation of the tumor recurrence, DFS will be censored at the last date the participant was known to be disease-free.
OS is the time from date of registration to date of death. In the absence of confirmation of death, survival time will be censored at the last date the participant is known to be alive."|up to 10 years|"Based on a protocol amendment
this study was shortened from 10 years to 2 years
the efficacy endpoints of disease free survival, and overall survival were deleted from the protocol.
Therefore, no analysis was performed for DFS or OS."||Months||95% Confidence Interval|Median
738149|NCT00446030|Primary|Percent of Participants With Grade 3/4 Clinical Congestive Heart Failure (CHF)|The percentage of participants with Grade 3/4 clinical CHF was calculated. Grade 3/4 CHF symptoms included cardiac failure congestive, cardiomyopathy, and left ventricular dysfunction (LVEF). Echocardiography (ECG) or multiple-gated acquisition (MUGA) scans were scheduled after Cycles 3 and 6 of chemotherapy, after every 3rd cycle of trastuzumab alone, at end of therapy and every 6 months at follow-up to measure changes in LVEF. Clinical symptoms e.g., shortness of breath, tachycardia, cough, neck vein distention, cardiomegaly, hepatomegaly were further investigated for CHF.|up to 2 years|Safety population - all participants who received at least 1 dose of any study treatment.||Percentage of Participants||95% Confidence Interval|Mean
738150|NCT00446095|Secondary|Overall Survival (OS)|OS: Time from date of first study drug administration to the date of death.|Overall survival is measured from the time of first administration of study drug to death. (Maximum duration of treatment 511days, Maximum duration of follow-up 812 Days)|Phase II only as was not collected in Phase I. Intention to treat (ITT) population is defined as all patients who received at least one dose of fostamatinib.||Days||95% Confidence Interval|Median
738151|NCT00446095|Secondary|Progression Free Survival (PFS)|PFS: Time from date of first study drug administration to the date of progressive disease as assessed according to the “Revised Response Criteria for Malignant Lymphoma”(Cheson 2007) or the date of death due to any cause, whichever occurred first.|Serial tumor assessments were taken at baseline (within 28 days of the start of treatment), and re-evaluated at Day 57, and every 12 weeks thereafter or to confirm response (Maximum duration of treatment 511 days, Maximum duration of follow-up 812 Days)|Phase II only as was not collected in Phase I. Intention to treat (ITT) population is defined as all patients who received at least one dose of fostamatinib.||Days||95% Confidence Interval|Median
738152|NCT00446095|Primary|Clinical Benefit Rate as Assessed According to the “Revised Response Criteria for Malignant Lymphoma” (Cheson 2007).|Proportion of patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD)|Serial tumor assessments were taken at baseline (within 28 days of the start of treatment), and re-evaluated at Day 57, and every 12 weeks thereafter or to confirm response (Maximum duration of treatment 511 days, Maximum duration of follow-up 812 Days)|Intention to treat (ITT) population is defined as all patients who received at least one dose of fostamatinib.||Participants|||Number
738153|NCT00446095|Primary|Overall Response Rate as Assessed According to the“Revised Response Criteria for Malignant Lymphoma” (Cheson 2007).|Proportion of patients with Complete Response (CR) or Partial Response (PR). Revised Response Criteria for Malignant Lymphoma categorises the response of the treatment of a patient's tumour to; CR: the disappearance of all evidence of disease; PR: ≥ 50% decrease in the sum of the perpendicular diameters (SPD) of the six largest dominant nodes plus no increase in the size of other nodes and no new sites of disease; Stable Disease (SD): less than a PR but not progressive disease; Relapsed Disease or PD: Any new lesion or increase by ≥ 50% of previously involved sites from nadir. Primary efficacy is based on Phase II patients only.|Serial tumor assessments were taken at baseline (within 28 days of the start of treatment), and re-evaluated at Day 57, and every 12 weeks thereafter or to confirm response . (Maximum duration of treatment 511 days, Maximum duration of follow-up 812 Days)|Intention to treat (ITT) population is defined as all patients who received at least one dose of fostamatinib.||Participants|||Number
738154|NCT00446134|Secondary|Relapsers at Follow-Up Visit 24|Includes patients who had undetectable Hepatitis Virus C (HVC) Ribonucleic Acid (RNA) at their last visit on drug.|Follow-Up Week 24|The analysis was performed using patients who had undetectable HVC RNA at their last visit on drug.||Participants|||Number
738155|NCT00446134|Secondary|Patients With Undetected Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) (<100 Copies/mL) at Treatment Week Follow-Up 24||Treatment Week Follow-Up 24|This analysis was performed using the Intent-to-Treat Population (ITT); undetectable HCV RNA defined as <100 copies/mL;Patients with a missing value at TW 12, TW 24 were considered Non-responders (detectable); a responder is defined as a patient with undetectable HCV RNA at FW 24 after achieving EVR at TW 12 and undetectable status at TW 24||Participants|||Number
738156|NCT00446134|Secondary|Patients With Anemia (Hemoglobin <10 g/dL) Up to Follow-up Week 24|The primary safety endpoint will be the numbers of patients with hemoglobin <10 g/dL (anemia) at any time during the treatment period. The comparison of anemia rates between taribavirin and ribavirin groups will be carried out using the Fisher's exact test or Chi-square test. The 95% confidence interval of the difference in proportion will be analyzed.|Treatment Week Follow-Up 24|The secondary analysis was performed using the Safety Population and 275 patients who received at least one dose of study drug were analyzed for safety.||Participants|||Number
738173|NCT00446199|Secondary|Change From Baseline to Week 12 in Vaginal pH|Vaginal pH determined following speculum examination using vaginal pH paper and recorded on case report form (CRF). Absolute change calculated as week 12 pH minus baseline pH.|Baseline until 12 weeks of treatment|Full analysis set (ITT). Numbers differ from the complete full analysis set due to missing data.||(pH)||Standard Deviation|Mean
738157|NCT00446134|Primary|Patients With Either Undetectable Serum HCV RNA (<100 Copies/ml) or at Least a 2-log Decrease From Baseline in Serum Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Treatment Week 12.|The primary efficacy endpoint was the numbers of responders at Treatment Week (TW) 12. Responders are defined as patients achieving either viral negativity or a partial response (PR). Viral negativity is defined as <100 copies/mL serum HCV RNA. A PR is defined as < 100 copies/mL serum HCV RNA and at least a 2-log decrease from baseline in serum HCV RNA levels. Responder rates with corresponding 95% confidence intervals were estimated for each treatment group.|Treatment Week 12|The primary efficacy analysis was performed using the Intent-to-Treat (ITT) population and 275 patients who received at least one dose of study drug were analyzed for efficacy.||Participants|||Number
738158|NCT00446147|Secondary|Number of Patients With Hand-foot Syndrome|Number of patients with any grade of hand-foot syndrome|Up to 2 years|||participants|||Number
738159|NCT00446147|Primary|Cumulative Dose of Capecitabine Until the Development of Grade 2 or Higher Hand-foot Syndrome|A total administered dose of capecitabine until the development of grade 2 or higher hand-foot syndrome during the chemotherapy.|Up to 2 years|||miligram per square meter||95% Confidence Interval|Median
738160|NCT00446199|Other Pre-specified|Change From Baseline to Week 4 in Weekly Mean Daily Severity of Moderate to Severe Hot Flushes (Mean Value)|Subjects record daily on the diary cards the frequency and severity of hot flushes during the treatment period as none, mild, moderate or severe. Daily score is calculated as [(2 x number of moderate hot flushes) + (3 x number of severe hot flushes)] / (total number of moderate to severe hot flushes on that day). Range = 0 (lowest severity) to 3 (highest severity). Absolute change calculated as week 4 severity moderate to severe hot flushes minus baseline severity.|Baseline until 4 weeks of treatment|Full analysis set (ITT) with last observation carried forward approach (LOCF). Numbers differ from the complete full analysis set due to missing Week 1 data.||scores on a scale||Standard Deviation|Mean
738161|NCT00446199|Other Pre-specified|Change From Baseline to Week 12 in Weekly Mean Daily Severity of Moderate to Severe Hot Flushes (Mean Value)|Subjects record daily on the diary cards the frequency and severity of hot flushes during the treatment period as none, mild, moderate or severe. Daily score is calculated as [(2 x number of moderate hot flushes) + (3 x number of severe hot flushes)] / (total number of moderate to severe hot flushes on that day). Range = 0 (lowest severity) to 3 (highest severity). Absolute change calculated as week 12 severity moderate to severe hot flushes minus baseline severity.|Baseline until 12 weeks of treatment|Full analysis set (ITT) with last observation carried forward approach (LOCF). Numbers differ from the complete full analysis set due to missing Week 1 data.||Scores on a scale||Standard Deviation|Mean
738162|NCT00446199|Other Pre-specified|Change From Baseline to Week 4 in Weekly Frequency of Moderate to Severe Hot Flushes (Mean Value)|Subjects record daily on the diary cards the frequency and severity of hot flushes during the treatment period as none, mild, moderate or severe. Absolute change calculated as week 4 number of moderate to severe hot flushes minus baseline number.|Baseline until 4 weeks of treatment|Full analysis set (ITT) with last observation carried forward approach (LOCF). Numbers differ from the complete full analysis set due to missing Week 1 data.||Hot Flushes per week||Standard Deviation|Mean
738163|NCT00446199|Other Pre-specified|Change From Baseline to Week 12 in Weekly Frequency of Moderate to Severe Hot Flushes (Mean Value)|Subjects record daily on the diary cards the frequency and severity of hot flushes during the treatment period as none, mild, moderate or severe. Absolute change calculated as week 12 number of moderate to severe hot flushes minus baseline number.|Baseline until 12 weeks of treatment|Full analysis set (ITT) with last observation carried forward approach (LOCF). Numbers differ from the complete full analysis set due to missing Week 1 data.||Hot Flushes per week||Standard Deviation|Mean
738164|NCT00446199|Secondary|Urogenital Symptoms: Number of Participants With Symptom 'Urination at Night'|Subjects self-assessed presence or absence of symptom; and if present recorded average number of times per night: 1; 2 to 4; more than 4.|After 12 weeks of treatment|Full analysis set (ITT). Numbers differ from the complete full analysis set due to missing data.||participants|||Number
738165|NCT00446199|Secondary|Urogenital Symptoms: Number of Participants With Symptom 'Involuntary Urination When Laughing or Coughing'|Subjects self-assessed presence or absence of symptom|After 12 weeks of treatment|Full analysis set (ITT). Numbers differ from the complete full analysis set due to missing data.||participants|||Number
738166|NCT00446199|Secondary|Urogenital Symptoms: Number of Participants With Symptom 'Frequent Urination'|Subjects self-assessed presence or absence of symptom|After 12 weeks of treatment|Full analysis set (ITT). Numbers differ from the complete full analysis set due to missing data.||participants|||Number
738167|NCT00446199|Secondary|Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Vaginal Bleeding Associated With Sexual Activity'|Subjects self-assessed symptom severity|After 12 weeks of treatment|Full analysis set. Numbers differ from the complete full analysis set due to missing data.||participants|||Number
738168|NCT00446199|Secondary|Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Vaginal Pain Associated With Sexual Activity'|Subjects self-assessed symptom severity|After 12 weeks of treatment|Full analysis set. Numbers differ from the complete full analysis set due to missing data.||participants|||Number
738169|NCT00446199|Secondary|Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Dysuria'|Subjects self-assessed symptom severity|After 12 weeks of treatment|Full analysis set. Numbers differ from the complete full analysis set due to missing data.||participants|||Number
738170|NCT00446199|Secondary|Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Vaginal and/or Vulvar Irritation/Itching'|Subjects self-assessed symptom severity|After 12 weeks of treatment|Full analysis set. Numbers differ from the complete full analysis set due to missing data.||participants|||Number
738171|NCT00446199|Secondary|Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Vaginal Dryness'|Subjects self-assessed symptom severity|After 12 weeks of treatment|Full analysis set. Numbers differ from the complete full analysis set due to missing data.||participants|||Number
738172|NCT00446199|Secondary|Change From Baseline to Week 12 in Vaginal Maturation Value|Calculated as (percentage of superficial cells) + 0.5 * (percentage of intermediate cells). Absolute change calculated as week 12 value minus baseline value.|Baseline until 12 weeks of treatment|Full analysis set (ITT). Numbers differ from the complete full analysis set due to missing data.||Percentages of cells||Standard Deviation|Mean
738174|NCT00446199|Primary|Change From Baseline to Week 4 in Weekly Mean Daily Severity of Moderate to Severe Hot Flushes (Median Value)|Subjects record daily on the diary cards the frequency and severity of hot flushes during the treatment period as none, mild, moderate or severe. Daily score is calculated as [(2 x number of moderate hot flushes) + (3 x number of severe hot flushes)] / (total number of moderate to severe hot flushes on that day). Range = 0 (lowest severity) to 3 (highest severity). Absolute change calculated as week 4 severity of moderate to severe hot flushes minus baseline severity.|Baseline until 4 weeks of treatment|Full analysis set (ITT) with last observation carried forward approach (LOCF). Numbers differ from the complete full analysis set due to missing Week 1 data.||Scorese on a scale||Full Range|Median
738175|NCT00446199|Primary|Change From Baseline to Week 12 in Weekly Mean Daily Severity of Moderate to Severe Hot Flushes (Median Value)|Subjects record daily on the diary cards the frequency and severity of hot flushes during the treatment period as none, mild, moderate or severe. Daily score is calculated as [(2 x number of moderate hot flushes) + (3 x number of severe hot flushes)] / (total number of moderate to severe hot flushes on that day). Range = 0 (lowest severity) to 3 (highest severity). Absolute change calculated as week 12 severity of moderate to severe hot flushes minus baseline severity.|Baseline until 12 weeks of treatment|Full analysis set (ITT) with last observation carried forward approach (LOCF). Numbers differ from the complete full analysis set due to missing Week 1 data.||Scores on a scale||Full Range|Median
738176|NCT00446199|Primary|Change From Baseline to Week 4 in Weekly Frequency of Moderate to Severe Hot Flushes (Median Value)|Subjects record daily on the diary cards the frequency and severity of hot flushes during the treatment period as none, mild, moderate or severe. Absolute change calculated as week 4 number of moderate to severe hot flushes minus baseline number.|Baseline until 4 weeks of treatment|Full analysis set (ITT) with last observation carried forward approach (LOCF). Numbers differ from the complete full analysis set due to missing Week 1 data.||Hot Flushes per week||Full Range|Median
738177|NCT00446199|Primary|Change From Baseline to Week 12 in Weekly Frequency of Moderate to Severe Hot Flushes (Median Value)|Subjects record daily on the diary cards the frequency and severity of hot flushes during the treatment period as none, mild, moderate or severe. Absolute change calculated as week 12 number of moderate to severe hot flushes minus baseline number.|Baseline until 12 weeks of treatment|Full analysis set (Intention to Treat (ITT)) with last observation carried forward approach (LOCF). Numbers differ from the complete full analysis set due to missing Week 1 data.||Hot Flushes per week||Full Range|Median
738178|NCT00446251|Secondary|The Number of Subjects With a Negative Crossmatch at the Time of Transplant.||Month 12 from start of study|As per protocol each subject was entered with intention to treat.||Participants|||Number
738179|NCT00446251|Secondary|The Number of Subjects Who Experience a Change From Baseline in Their Panel of Reactive Antibody (PRA) Titers at 12 Months Post Rituximab Infusion.||Month 12 from start of study|||Participants|||Number
738180|NCT00446251|Primary|The Number of Subjects Who Experience a Decrease in Their Panel of Reactive Antibodies (PRA) at 6 Months Post Rituximab Infusion.|the number of subjects who experience a decrease in their Panel of Reactive Antibodies (PRA) at 6 months and 12 months post Rituximab infusion|Month 6 from start of study|12 subjects received the full dose of Rituximab AND continued to month 6 post infusion.||Participants|||Number
738181|NCT00446264|Secondary|Number of Adverse Events|The number of adverse events related to the procedure and to the immunosuppression|1 year|||number events|||Number
738182|NCT00446264|Secondary|Percentage of Time Spent in Hypoglycemia (<0.70 mg/L)|percentage of time spent in hypoglycemia derived from CGMS (Continuous Glucose Monitoring System)|1 year|||percentage of time||Standard Deviation|Mean
738183|NCT00446264|Secondary|HbA1c < 6.5%|The percentage of subjects with HbA1c < 6.5% at 1 year after the first transplant|1 year|||Percentage of participants||Standard Deviation|Mean
738184|NCT00446264|Secondary|Plasma C-peptide|Level of plasma C-peptide at 1 year after the first transplant|1 year|||ng/ml||Standard Deviation|Mean
738185|NCT00446264|Secondary|Hypoglycemic Events|Percentage of subjects free of severe hypoglycemic events from day 0 to day 365 with the day of transplant designated day 0|day 0 to day 365|||Percentage of patients||Standard Deviation|Mean
738186|NCT00446264|Primary|Composite Criteria: Insulin Independence and Glycosylated Hemoglobin (HbA1c) Under 6.5% at One Year|The percentage of insulin independents subjects with an HbA1c less than 6.5% at one year after last transplant|1 year|||Percentage of patients||Standard Deviation|Mean
738187|NCT00446290|Primary|Number of Participants With DLTs|Dose limiting toxicity (DLTs) was determined during the Wrst two cycles of treat- ment. The definitions of DLTs were as follows: (1) grade 4 neutropenia lasting for more than 5 days, or grade 3/4 neu- tropenia with fever; (2) grade 4 thrombocytopenia; (3) any other grade 3 non-hematological toxicity (excluding alope- cia); or (4) treatment delay of more than 2 weeks following the time of planned treatment. Maximal tolerated dose was defined as that the DLTs were observed in two or more patients from a cohort of two to six patients|2 years|All patients who were initially enrolled in dose escalation scheme.||participants|||Number
738188|NCT00446446|Secondary|Number of Participants With Adverse Events|The severity of each adverse event (AE) was graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (where grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal) with the exception of some dermatology/skin AEs that were graded using the CTCAE v3.0 with modifications. Serious AEs include any event that was fatal, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or other significant medical hazard. Treatment-related adverse events (TRAEs) are those for which the investigator considered there to be a reasonable possibility that the event may have been caused by study drug.|The reporting time frame for Adverse Events is from first dose date to 30 days since the last dose date date. The median time frame is 2.4 months.|Safety analysis set (all enrolled participants who received at least 1 dose of panitumumab)||participants|||Number
738189|NCT00446446|Secondary|Overall Survival (OS)|Overall Survival was defined as the time from Day 1 to the date of death. For participants who did not die while on study, or were lost to follow-up, survival was censored at the end of study, or the date of last contact (whichever was first).|From first dose until the data cut-off date of 16 December 2010; median duration of treatment was 9.0 weeks (range: 3.0 to 68.9 weeks).|Full analysis set||months||95% Confidence Interval|Median
738190|NCT00446446|Secondary|Progression Free Survival (PFS)|"PFS was defined as the time from Day 1 to the first date of disease progression, as defined by a modified version of the RECIST criteria (version 1.0), or death due to any cause (whichever comes first). Participants who were alive who did not meet the criteria for progression by the analysis data cut-off date were censored at the date of last evaluable disease assessment.
PFS was analyzed using the Kaplan-Meier method."|From first dose until the data cut-off date of 16 December 2010; median duration of treatment was 9.0 weeks (range: 3.0 to 68.9 weeks).|Full analysis set||months||95% Confidence Interval|Median
738191|NCT00446446|Secondary|Time to Progression|Time to progression was defined as the time from Day 1 to the date of disease progression using a modified version of the RECIST criteria (version 1.0). Participants not meeting the criteria for progression by the analysis data cut-off date were censored at the date of last evaluable disease assessment. Time to progression was analyzed using the Kaplan-Meier method.|From first dose until the data cut-off date of 16 December 2010; median duration of treatment was 9.0 weeks (range: 3.0 to 68.9 weeks).|Full analysis set||months||95% Confidence Interval|Median
738192|NCT00446446|Secondary|Rate of Disease Control|"Rate of disease control was defined as the percentage of participants with CR, PR, or stable disease (SD), as defined by a modified version of the RECIST criteria (version 1.0), prior to initiation of subsequent anti-cancer therapy.
SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD of target lesions and no progression of non-target lesions and no new lesions, or, if no target lesions were identified at screening, the persistence of one or more non-target lesion(s) not qualifying for either CR or PD."|From first dose until the data cut-off date of 16 December 2010; median duration of treatment was 9.0 weeks (range: 3.0 to 68.9 weeks).|Full analysis set with measurable disease at Baseline||percentage of participants||95% Confidence Interval|Number
738193|NCT00446446|Secondary|Duration of Response|"Duration of response was defined as the time from first confirmed CR or PR to the earliest date of disease progression per a modified version of the RECIST criteria (version 1.0). Participants not meeting the criteria for progression by the analysis data cut-off date were censored at the date of last evaluable disease assessment. Duration of response was analyzed using the Kaplan-Meier method.
PD: At least a 20% increase in the size of target lesions, or an increase of 20% or greater of non-target lesions and the lesion(s) measure ≥ 10 mm in one dimension at the time of progression, or any new lesions."|From first dose until the data cut-off date of 16 December 2010; median duration of treatment was 9.0 weeks (range: 3.0 to 68.9 weeks)|Full analysis set participants with an objective response||months||95% Confidence Interval|Median
738194|NCT00446446|Secondary|Time to Response|Time to response was defined as the time from Study Day 1 to the first CR or PR that was subsequently confirmed.|From first dose until the data cut-off date of 16 December 2010; median duration of treatment was 9.0 weeks (range: 3.0 to 68.9 weeks)|Full analysis set participants with objective responses||weeks||Inter-Quartile Range|Median
738195|NCT00446446|Primary|Objective Response Rate|Assessments are based on investigator’s review of scans using a modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. Objective response rate was defined as the percentage of participants with a best tumor response of complete response (CR) or partial response (PR) prior to initiation of subsequent anti-cancer therapy. CR or PR was confirmed no less than 28 days after the criteria for response were first met. CR: Disappearance of all target lesions, non-target lesions and no new lesions. PR: At least a 30% decrease in the size of target lesions and no progression of existing non-target lesions (defined as an increase in lesion size of ≥ 20%) and no new lesions, or, the disappearance of all target lesions and the persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease (PD) and no new lesions.|From first dose of study drug until the data cut-off date of 16 December 2010. Median duration of treatment was 9.0 weeks (range: 3.0 to 68.9 weeks).|Full analysis set (all enrolled participants who received at least 1 dose of panitumumab) with measurable disease at Baseline||percentage of participants||95% Confidence Interval|Number
738196|NCT00446459|Secondary|The Number of Transplants With a Negative Crossmatch at Transplant.|The number negative crossmatch transplants up to month 12. Positivie crossmatch transplant carries a higher risk for rejection. Subjects who's PRA decreased by 10% at month 8 and who went on to the Mycophenolate mofetil + Rituximab study were followed to month 8. Those subjects who stayed on the Mycophenolate mon-therapy study were observed for negative crossmatch transplants to 12 months.|Number of Transplants with a Negative Crossmatch.|||Participant|||Number
738197|NCT00446459|Secondary|The Number of Pariticpants With a White Blood Cell Count Below 2.0 Thousand (Low) or Total IgG/IgM Titers Below Range (620-1490 mg/dL).|The number of subjects with adverse hematologic effects with MMF while on-study. Subjects who's PRA decreased by 10% at month 8 and who went on to the Mycophenolate mofetil + Rituximab study were followed to month 8. Those subjects who stayed on the Mycophenolate mon-therapy study were observed for hematologic effects up to 12 months.|Enrollment to month 12.|||Participant|||Number
738198|NCT00446459|Secondary|The Number of Kidney Transplant up to 12 Months.|The number of kidney transplants up to month 12. Subjects who's PRA decreased by 10% at month 8 and who went on to the Mycophenolate mofetil + Rituximab study were followed to month 8. Those subjects who stayed on the Mycophenolate mon-therapy study were observed for infection over 12 months or until they seperated from the study.|Enrollment to month 8 or month 12 post enrollment.|||Participants|||Number
738199|NCT00446459|Primary|The Number of Subjects With a 10% Decrease in PRA Level at Month 8.||Enrollment to month 8|||Participant|||Number
738200|NCT00446459|Secondary|The Number of Subjects With Significant Infections up to Month 12.|The number of infections while on-study up to month 12. Subjects who's PRA decreased by 10% at month 8 and who went on to the Mycophenolate mofetil + Rituximab study were followed to month 8. Those subjects who stayed on the Mycophenolate mon-therapy study were observed for infection over 12 months or until they seperated from the study.|From enrollment to month 12.|Forty five subjects were screened, of these 37 received MMF.||Participants|||Number
738213|NCT00446563|Secondary|Change From Baseline to the End of Study in Left Ventricular End-Systolic Volume (LVESV) Assessed by MRI||Baseline to week 52|The intention-to-treat (ITT) population consisted of all patients from the safety population who had a baseline MRI assessment. If patients dropped out prior to the scheduled observation period, every effort should have been taken to get a final MRI scan which could then be used for the ITT analysis.||ml||Standard Deviation|Mean
738201|NCT00446511|Secondary|Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to Week 26|After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using a calibrated standard sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. A negative number indicates lowered blood pressure.|Core Baseline (Week 0) to Week 26|Extension ITT population: All patients that had both baseline and at least 1 post-Week 12 assessment of any efficacy variable (sitting systolic/diastolic BP) during the extension. Baseline is the Week 0 value. Extension endpoint is the Week 26 or last observation after the core endpoint but before Week 26 carried forward value.||mmHg||Standard Deviation|Mean
738202|NCT00446511|Secondary|Change From Baseline in Post-dosing 24-hour Mean Systolic and Diastolic Ambulatory Blood Pressure at Week 20|24-hour ambulatory blood pressure monitoring (ABPM) was conducted once during the extension in a subset of patients at selected centers. For all patients who completed a qualifying ABPM at baseline, an ABPM was to be performed at Week 20. The ABPM monitor was placed on the non-dominant arm.|Core Baseline (Week 0) to Week 20|ABPM population: All ITT patients who received the 24-hour ambulatory blood pressure monitoring (ABPM) measurements at both baseline and Week 20. Patients were excluded if their baseline ABPM was measured after active treatment dose (considered invalid baseline).||mmHg||Standard Deviation|Mean
738203|NCT00446511|Secondary|Percentage of Non-CKD Patients Achieving Systolic and Diastolic BP Control at Week 26|Systolic and diastolic blood pressure (BP) control was defined as msSBP and msDBP < 95th percentile for gender, age, and height. After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using a calibrated standard sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit.|Week 26|The extension ITT population consisted of all extension patients that had both baseline and at least one post-Week 12 assessment of any efficacy variable (sitting systolic/diastolic blood pressure) during the extension. Patients were analyzed according to the treatment they were assigned to at the beginning of their extension.||Percentage of patients|||Number
738204|NCT00446511|Secondary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to Week 26|After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using a calibrated standard sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. A negative number indicates lowered blood pressure.|Core Baseline (Week 0) to Week 26|Extension ITT population: All patients that had both baseline and at least 1 post-Week 12 assessment of any efficacy variable (sitting systolic/diastolic BP) during the extension. Baseline is the Week 0 value. Extension endpoint is the Week 26 or last observation after the core endpoint but before Week 26 carried forward value.||mmHg||Standard Deviation|Mean
738205|NCT00446511|Primary|Number of Patients With Adverse Events||Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients)|Extension safety population||Participants|||Number
738206|NCT00446563|Secondary|Percentage of Participants Who Experienced Adverse Events (AEs)|An adverse event was the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after obtaining informed consent even if the event was not considered to be related to study drug. Medical conditions/diseases present before obtaining informed consent were only considered adverse events if they worsened after study start. Abnormal laboratory values or test results constituted adverse events only if they induced clinical signs or symptoms, required study drug discontinuation or required therapy.|Baseline to week 52|The safety population consisted of the sample of all randomized patients who applied study medication at least once.||Percentage of participants|||Number
738207|NCT00446563|Secondary|Percentage of Participants Achieving Target Blood Pressure at Week 52|Target blood pressure defined as having a mean sitting systolic blood pressure (MSSBP) < 140 mm Hg and a mean sitting diastolic blood pressure (MSDBP) < 90 mm Hg.|Week 52|The intention-to-treat (ITT) population consisted of all patients from the safety population who had a baseline MRI assessment. If patients dropped out prior to the scheduled observation period, every effort should have been taken to get a final MRI scan which could then be used for the ITT analysis.||Percentage of participants|||Number
738208|NCT00446563|Secondary|Change From Baseline to End of Study in Levels of High-sensitivity C-reactive Protein (Hs-CRP)||Baseline to week 52|The safety population consisted of the sample of all randomized patients who applied study medication at least once.||mg/l||Standard Deviation|Mean
738209|NCT00446563|Secondary|Change From Baseline to End of Study in Levels of N-terminal Pro-B Type Natriuretic Peptide (NT-proBNP)||Baseline to week 52|The safety population consisted of the sample of all randomized patients who applied study medication at least once.||pg/ml||Standard Deviation|Mean
738210|NCT00446563|Secondary|Change From Baseline to the End of Study in the Ascending Aortic Diameter Assessed by MRI||Baseline to week 52|The intention-to-treat (ITT) population consisted of all patients from the safety population who had a baseline MRI assessment. If patients dropped out prior to the scheduled observation period, every effort should have been taken to get a final MRI scan which could then be used for the ITT analysis.||mm||Standard Deviation|Mean
738211|NCT00446563|Secondary|Change From Baseline to the End of Study in Left Atrial (LA) Area Assessed by MRI||Baseline to week 52|The intention-to-treat (ITT) population consisted of all patients from the safety population who had a baseline MRI assessment. If patients dropped out prior to the scheduled observation period, every effort should have been taken to get a final MRI scan which could then be used for the ITT analysis.||cm˄2||Standard Deviation|Mean
738212|NCT00446563|Secondary|Change From Baseline to the End of Study in Left Ventricular End-Systolic Volume (LVESV) Normalized to Body Surface Area Assessed by MRI||Baseline to week 52|The intention-to-treat (ITT) population consisted of all patients from the safety population who had a baseline MRI assessment. If patients dropped out prior to the scheduled observation period, every effort should have been taken to get a final MRI scan which could then be used for the ITT analysis.||ml||Standard Deviation|Mean
738268|NCT00455312|Secondary|Incidence of Regimen Related Mortality at 100 Days|all deaths without previous relapse or progression|100 days|||Participants|||Count of Participants
738214|NCT00446563|Secondary|Change From Baseline to the End of Study in Left Ventricular End-diastolic Volume (LVEDV) Normalized to Body Surface Area Assessed by MRI||Baseline to week 52|The intention-to-treat (ITT) population consisted of all patients from the safety population who had a baseline MRI assessment. If patients dropped out prior to the scheduled observation period, every effort should have been taken to get a final MRI scan which could then be used for the ITT analysis.||ml||Standard Deviation|Mean
738215|NCT00446563|Secondary|Change From Baseline to the End of Study in Left Ventricular End-diastolic Volume (LVEDV) Assessed by MRI||Baseline to week 52|The intention-to-treat (ITT) population consisted of all patients from the safety population who had a baseline MRI assessment. If patients dropped out prior to the scheduled observation period, every effort should have been taken to get a final MRI scan which could then be used for the ITT analysis.||ml||Standard Deviation|Mean
738216|NCT00446563|Secondary|Change From Baseline to the End of Study in Left Ventricular Ejection Fraction (LVEF) Assessed by MRI|Ejection fraction is a measurement of the percentage of blood that is pumped out of a filled ventricle with each heartbeat.|Baseline to week 52|The intention-to-treat (ITT) population consisted of all patients from the safety population who had a baseline MRI assessment. If patients dropped out prior to the scheduled observation period, every effort should have been taken to get a final MRI scan which could then be used for the ITT analysis.||Percentage||Standard Deviation|Mean
738217|NCT00446563|Secondary|Change From Baseline to the End of Study in Posterior Wall Thickness Assessed by MRI||Baseline to week 52|The intention-to-treat (ITT) population consisted of all patients from the safety population who had a baseline MRI assessment. If patients dropped out prior to the scheduled observation period, every effort should have been taken to get a final MRI scan which could then be used for the ITT analysis.||mm||Standard Deviation|Mean
738218|NCT00446563|Secondary|Change From Baseline to the End of Study in Interventricular Septum Thickness (IVS) Assessed by MRI||Baseline to week 52|The intention-to-treat (ITT) population consisted of all patients from the safety population who had a baseline MRI assessment. If patients dropped out prior to the scheduled observation period, every effort should have been taken to get a final MRI scan which could then be used for the ITT analysis.||mm||Standard Deviation|Mean
738219|NCT00446563|Secondary|Change From Baseline to the End of Study in Left Ventricular Mass Index (LVMI) Normalized to Body Surface Area Assessed by MRI||Baseline to week 52|The intention-to-treat (ITT) population consisted of all patients from the safety population who had a baseline MRI assessment. If patients dropped out prior to the scheduled observation period, every effort should have been taken to get a final MRI scan which could then be used for the ITT analysis.||g/m˄2||Standard Deviation|Mean
738220|NCT00446563|Primary|Change From Baseline in Left Ventricular Mass Index (LVMI) Measured Via Magnetic Resonance Imaging (MRI)||Baseline to week 52|The intention-to-treat (ITT) population consisted of all patients who had a baseline MRI assessment. If patients dropped out prior to the scheduled observation period, every effort should have been taken to get a final MRI scan which could then be used for the ITT analysis.||g/m˄2||Standard Deviation|Mean
738221|NCT00446641|Secondary|Post-treatment ARU|mean of ARU value of individual participants after 4 weeks treatment|after 4 weeks treatment|||ARU||Standard Deviation|Mean
738222|NCT00446641|Secondary|Difference of Post-treatment ARU and Baseline ARU|summation of change of ARU (posttreatment ARU - baseline ARU) of individual patients|baseline ARU measured at the randomization and post-treatment ARU measured at the 4weeks treatment with study medication|||change of ARU measured||Standard Deviation|Mean
738223|NCT00446641|Secondary|Any Bleeding Complications|any bleeding events causing medical attention|events ocurred during study medication after randomization|||participants|||Number
738224|NCT00446641|Secondary|Fatal or Major Bleeding Complications;|Fatal or life-threatening bleeding was defined as any fatal bleeding event, a drop in hemoglobin of ≥ 50g/L, or significant hypotension with need for inotropic agents, symptomatic intracranial hemorrhage, or transfusion of ≥ 4 units of red-blood cells or equivalent amount of whole blood. Major bleeding was defined as significantly disabling bleedings, intraocular bleeding leading to significant visual loss, or bleeding requiring transfusion of ≤ 3 units of red-blood cells or equivalent amount of whole blood|events ocurred during study medication after randomization|||participants|||Number
738225|NCT00446641|Secondary|Bleeding Time (BT)|for evaluation of the extent of the bleeding time prolongation by additional cilostazol|4 weeks after reatment|||seconds||Standard Deviation|Mean
738226|NCT00446641|Secondary|Aspirin Resistance (ARU ≥ 500)|The number of participants with ARUs values ≥500 on the Ultra Rapid Platelet Function Assay-ASA; ARUs values|4 weeks after reatment|||participants|||Number
738227|NCT00446641|Primary|Aspirin Resistance (ARU ≥ 550)|The number of patients with aspirin reaction units (ARUs) values ≥ 550 on the Ultra Rapid Platelet Function Assay-ASA among the recruited patients|4 weeks after treatment|||participants|||Number
738228|NCT00446654|Primary|Change in Baseline to 3 Months in Best Corrected Visual Acuity|"Visual acuity was measured with a standard eye exam using the preferred research based eye chart (LogMar chart). On the LogMar chart each letter has a score value of 0.02 log units. LogMAR VA = 0.1 + LogMAR value of the best line read - 0.02 X (number of letters read).
The outcome measure presented is the difference in LogMAR between baseline and at three months."|Baseline and 3 months|Analysis was performed on all patients who received at least one treatment.||logMAR||Standard Deviation|Mean
738229|NCT00446654|Secondary|To Evaluate Possible Suppression and/or Regression of Choroidal Neovascularization||3 months||||||
738230|NCT00446654|Secondary|Safety of 2-weekly or 4-weekly Administration of CGC-11047||3 months||||||
738231|NCT00446797|Secondary|Modified Brief Pain Inventory Short Form (m-BPI-sf) – Pain Interference Index|"m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.
The pain interference index is the average of pain interference questions 5A to 5G. Scale: 0 = does not interfere to 10 = completely interferes"|Days 2, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment||scores on a scale||Standard Deviation|Mean
738269|NCT00455312|Primary|Neutrophil Engraftment|Defined as an absolute neutrophil count (ANC) >5 x 10^8/L (first of three consecutive laboratory measurements on different days) with at least 10% donor cells by day 100. Demonstrate sustained engraftment after a fludarabine based preparative regimen in patients with dyskeratosis congenita followed by hematopoietic cell transplantation.|Day 100|||Participants|||Count of Participants
738232|NCT00446797|Secondary|Modified Brief Pain Inventory Short Form (m-BPI-sf) – Pain Interference Question 5G|"m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.
Q5G: Subject response to ‘how, during the past 24 hours, pain has interfered with your enjoyment of life’. Scale: 0 = does not interfere to 10 = completely interferes"|Days 2, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment||scores on a scale||Standard Deviation|Mean
738233|NCT00446797|Secondary|Modified Brief Pain Inventory Short Form (m-BPI-sf) – Pain Interference Question 5F|"m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.
Q5F: Subject response to ‘how, during the past 24 hours, pain has interfered with your sleep’. Scale: 0 = does not interfere to 10 = completely interferes"|Days 2, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment||scores on a scale||Standard Deviation|Mean
738234|NCT00446797|Secondary|Modified Brief Pain Inventory Short Form (m-BPI-sf) – Pain Interference Question 5E|"m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.
Q5E: Subject response to ‘how, during the past 24 hours, pain has interfered with your relations with other people’. Scale: 0 = does not interfere to 10 = completely interferes"|Days 2, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment||scores on a scale||Standard Deviation|Mean
738235|NCT00446797|Secondary|Modified Brief Pain Inventory Short Form (m-BPI-sf) – Pain Interference Question 5D|"m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.
Q5D: Subject response to ‘how, during the past 24 hours, pain has interfered with your normal work (work outside the home and housework)’. Scale: 0 = does not interfere to 10 = completely interferes"|Days 2, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment||scores on a scale||Standard Deviation|Mean
738236|NCT00446797|Secondary|Modified Brief Pain Inventory Short Form (m-BPI-sf) – Pain Interference Question 5C|"m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.
Q5C: Subject response to ‘how, during the past 24 hours, pain has interfered with your walking ability’. Scale: 0 = does not interfere to 10 = completely interferes"|Days 2, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment||scores on a scale||Standard Deviation|Mean
738237|NCT00446797|Secondary|Modified Brief Pain Inventory Short Form (m-BPI-sf) – Pain Interference Question 5B|"m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.
Q5B: Subject response to ‘how, during the past 24 hours, pain has interfered with your mood’. Scale: 0 = does not interfere to 10 = completely interferes"|Days 2, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment||scores on a scale||Standard Deviation|Mean
738238|NCT00446797|Secondary|Modified Brief Pain Inventory Short Form (m-BPI-sf) – Pain Interference Question 5A|"m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.
Q5A: Subject response to ‘how, during the past 24 hours, pain has interfered with your general activity. Scale: 0 = does not interfere to 10 = completely interferes"|Days 2, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment||scores on a scale||Standard Deviation|Mean
738239|NCT00446797|Secondary|Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Index|"m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.
Pain severity index is the average of the pain severity questions 1 to 4. Scale: 0 = no pain to 10 = pain as bad as you can imagine"|Days 2, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment||scores on a scale||Standard Deviation|Mean
738240|NCT00446797|Secondary|Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 4|"m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.
Q4: Subject response to 'how much pain you have right now'. Scale: 0 = no pain to 10 = pain as bad as you can imagine"|Days 2, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment||scores on a scale||Standard Deviation|Mean
738241|NCT00446797|Secondary|Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 3|"m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.
Q3: Subject response to 'describe your pain on the average'. Scale: 0 = no pain to 10 = pain as bad as you can imagine"|Days 2, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment||scores on a scale||Standard Deviation|Mean
738242|NCT00446797|Secondary|Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 2|"m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.
Q2: Subject response to 'describe your pain at its least in the last 24 hours'. Scale: 0 = no pain to 10 = pain as bad as you can imagine"|Days 2, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment||scores on a scale||Standard Deviation|Mean
738302|NCT00455858|Secondary|Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 12|Change in Glycosylated Haemoglobin A1c (HbA1c) at week 12 from baseline|week 0, week 12|The analysis was based on Full Analysis Set (FAS) without any imputations. The definition of FAS is: All enrolled subjects exposed to at least one dose of study product and have at least one HbA1c data after 3 months being exposed to the study product.||percentage change in HbA1c||Standard Deviation|Mean
738243|NCT00446797|Secondary|Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 1|"m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.
Q1: Subject response to 'describe your pain at its worst in the last 24 hours'. Scale: 0 = no pain to 10 = pain as bad as you can imagine"|Days 1, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment||scores on a scale||Standard Deviation|Mean
738244|NCT00446797|Secondary|Subject Assessment of Normal Function / Activity|Subject response to question: “How does your ankle injury affect your walking and normal activity?” Scale from 1 = Normal walking/activity and no pain to 5 = Severely restricted walking due to pain and can’t resume normal activities (normal activities defined as all activity that a subject did on a routine basis, including work and recreation)|Days 2, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment||participants|||Number
738245|NCT00446797|Secondary|Pain Relief - MITT Population|"Subject's response to the statement My relief from starting pain is. Scale from 0 = None to 4 = Complete."|Days 2, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment||participants|||Number
738246|NCT00446797|Secondary|Physician Global Assessment of Ankle Injury|Investigator evaluation of overall severity of ankle injury. Scale: 5 point from 1 = Very mild (very mild signs and symptoms of ankle sprain) to 5 =Very severe (very severe signs and symptoms of ankle sprain)|Days 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment||participants|||Number
738247|NCT00446797|Secondary|Subject's Global Assessment of Ankle Injury|Subject response to question: “Considering all the ways your ankle injury affects you, how are you doing today?” Scale: 5 point from 1 = very good (no symptoms and no limitation of normal activities) to 5 = very poor (very severe symptoms which are intolerable and inability to carry out all normal activities).|Days 2, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment||participants|||Number
738248|NCT00446797|Secondary|Number of Subjects Responding (Improving) - MITT Population|The number of subjects showing a response: a decrease of at least 20 mm (that is improvement) on the pain visual analog scale (VAS) scale|Days 2, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment (i.e. a subset of treated subjects).||participants|||Number
738249|NCT00446797|Secondary|Change From Baseline in Pain Visual Analog Scale (VAS) - Modified Intent to Treat Population|Assessment of ankle pain by VAS: 100 mm horizontal line, left end being “No Pain” & right end being “Worst Possible Pain”. Participants drew vertical line on horizontal scale to best reflect current pain on full weight bearing of injured ankle. Distance from left end of line to mark. Change: mean score at observation minus mean score at baseline|Baseline and days 2, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment (i.e. a subset of treated subjects).||scores on a scale||Standard Deviation|Mean
738250|NCT00446797|Primary|Change From Baseline at Day 3 in Pain Visual Analog Scale (VAS) - Per Protocol Population|Assessment of ankle pain by VAS: 100 mm horizontal line with left end being “No Pain” & right end being “Worst Possible Pain”. Participants drew vertical line on horizontal scale to best reflect current pain on full weight bearing of injured ankle. Distance from left end of line to mark. Change: mean score at day 3 minus mean score at baseline|Baseline and day 3|Per protocol (PP) population included subjects who were randomized, received full loading dose of study medication on day 1 and took no prohibited medications up to and including day 3, had valid baseline and day 3 VAS scores and had no major protocol violations before or during the study (i.e. a subset of treated subjects).||scores on a scale||Standard Deviation|Mean
738251|NCT00455195|Secondary|Change From Baseline in Quality of Life Related to Physical Component Score (PCS) as Measured by the Medical Outcomes Study (MOS) Short Form-36 Health Survey For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600)|The Medical Outcomes Study Short Form (MOS SF)-36 questionnaire consists of 36 items grouped into 8 domains designed to assess generic health-related quality of life in healthy and ill adult populations. Physical Component Score reports the four domains of physical functioning, role-physical, bodily pain, and general health and is standardized as Z-scores (scale of 0-100). Higher scores are associated with better quality of life. Change is calculated as the value minus the baseline value. Time frames are stated from the start of the double-blind study AGLU02704 (NCT00158600).|Week 0 , Week 104|Intent-to-treat population of participants who had valid baseline (Week 0) and Week 104 data.||units on a scale||Standard Deviation|Mean
738252|NCT00455195|Secondary|Baseline Values (Week 0) for Quality of Life Related to Physical Component Score (PCS) as Measured by the Medical Outcomes Study (MOS) Short Form-36 Health Survey For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600)|The Medical Outcomes Study Short Form (MOS SF)-36 questionnaire consists of 36 items grouped into 8 domains designed to assess generic health-related quality of life in healthy and ill adult populations. Physical Component Score reports the four domains of physical functioning, role-physical, bodily pain, and general health and are standardized as Z-scores (scale of 0-100). Higher scores are associated with better quality of life. Time frames are stated from the start of the double-blind study AGLU02704 (NCT00158600).|Week 0|Intent-to-treat population of participants with valid baseline (Week 0) PCS surveys.||units on a scale||Standard Deviation|Mean
738270|NCT00455429|Secondary|Plasma Concentration of JNJ-26113100|Blood samples for pharmacokinetic (PK) analysis were collected before dosing and at 0.25 to 3 hours after dosing at randomization (Day 1) and Week 3 visit and at 0.25 to 3 hours, 4 to 6 hours, and 7 to 12 hours after dosing at Week 6.|Before dosing on Day 1, Week 3, Week 6; after dosing at 0.25 to 3 hours on Day 1, Week 3, Week 6; after dosing at 4 to 6 hours and 7 to 12 hours on Week 6|Intent-to-treat (ITT) analysis set included all participants who were randomly assigned to treatment groups and received at least 1 dose of study drug. LOCF method was used.||nanogram (ng)/milli litre (mL)||Standard Deviation|Mean
738378|NCT00456885|Primary|Change in Body Mass Index||16 weeks from the start of each treatment period.|||Kg/m^2||95% Confidence Interval|Mean
738253|NCT00455195|Primary|Change From Baseline (Week 0) in the Percent Predicted Forced Vital Capacity (FVC) at Week 104 For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600)|Forced vital capacity (FVC) is a standard pulmonary function test used to quantify respiratory muscle weakness. FVC is the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. Predicted forced vital capacity is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FVC = (observed value)/(predicted value) * 100%. Time frames are stated from the start of the double-blind study AGLU02704 (NCT00158600). Change is calculated as the value minus the baseline value.|Week 0, Week 104|Intent-to-treat population of participants who had both baseline (Week 0) and Week 104 data.||percent of predicted FVC||Standard Deviation|Mean
738254|NCT00455195|Primary|Baseline Values (Week 0) for Percent Predicted Forced Vital Capacity (FVC) For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600)|Forced vital capacity (FVC) is a standard pulmonary function test used to quantify respiratory muscle weakness. FVC is the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. Predicted forced vital capacity is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FVC = (observed value)/(predicted value) * 100%. Time frames are stated from the start of the double-blind study AGLU02704 (NCT00158600).|Week 0|Intent-to-treat population||percent of predicted FVC||Standard Deviation|Mean
738255|NCT00455195|Secondary|Change From Baseline (Week 0) for Percent Predicted Proximal Muscle Strength of the Lower Limbs as Measured by Quantitative Muscle Testing (QMT) at Week 104 For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600)|Quantitative muscle testing (QMT) is a standardized system to measure muscle force production during maximal voluntary isometric contraction. QMT data were collected directly from sensors into laptop computers. Predicted normal values for QMT are based on a formula using sex, age and body mass index of a person, and are an estimate of healthy muscle force. Percent of predicted QMT = (observed value)/(predicted value) * 100%. The QMT Leg Score is the average of the bilateral means for percent predicted knee flexors and extensors. A value of 100% indicates 'normal' muscle strength.|Week 0, Week 104|Intent-to-treat population of participants who had both baseline (Week 0) and Week 104 data.||percent of predicted QMT||Standard Deviation|Mean
738256|NCT00455195|Primary|Change From Baseline (Week 0) in the Six-Minute Walk Test (6MWT) at Week 104 For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600)|Six-Minute Walk Test (6MWT) measures the distance walked (in meters) in 6 minutes. A longer distance indicates greater endurance. Time frames are stated from the start of the double-blind study AGLU02704 (NCT00158600). Change is calculated as the value minus the baseline value.|Week 0, Week 104|Intent-to-treat population of participants who had both baseline (Week 0) and Week 104 data.||meters||Standard Deviation|Mean
738257|NCT00455195|Primary|Baseline Values (Week 0) of Functional Endurance as Measured by Six-Minute Walk Test (6MWT) For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600)|Six-Minute Walk Test (6MWT) measures the distance walked (in meters) in 6 minutes. A longer distance indicates greater endurance. Time frames are stated from the start of the double-blind study AGLU02704 (NCT00158600).|Week 0|Intent-to-treat population.||meters||Standard Deviation|Mean
738258|NCT00455195|Secondary|Baseline Values (Week 0) for Percent Predicted Proximal Muscle Strength of the Lower Limbs as Measured by Quantitative Muscle Testing (QMT) For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600)|Quantitative muscle testing (QMT) is a standardized system to measure muscle force production during maximal voluntary isometric contraction. QMT data were collected directly from sensors into laptop computers. Predicted normal values for QMT are based on a formula using sex, age and body mass index of a person, and are an estimate of healthy muscle force. Percent of predicted QMT = (observed value)/(predicted value) * 100%. The QMT Leg Score is the average of the bilateral means for percent predicted knee flexors and extensors. A value of 100% indicates 'normal' muscle strength.|Week 0|Intent-to-treat population||percent of predicted QMT||Standard Deviation|Mean
738259|NCT00455195|Primary|Summary of Participants Reporting Treatment-Emergent Adverse Events For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600)|"The numbers of participants who experienced Adverse Events (AEs), Serious Adverse Events (SAEs), treatment-related AEs, and Infusion Associated Reactions (IARs). Summary is based on treatment-emergent AEs (TEAEs), defined as AEs that occurred following the initiation of study treatment with alglucosidase alfa.
Participants with long-term exposure to alglucosidase alfa (those from the Alglucosidase Alfa/Alglucosidase Alfa treatment group) are included. Time frames are stated from the start of the double-blind study AGLU02704 (NCT00158600)."|Week 0 to 2.5 years|The safety population includes all participants randomized to alglucosidase alfa treatment in AGLU02704 (NCT00158600) who received at least one infusion of alglucosidase alfa.||participants|||Number
738260|NCT00455312|Secondary|Incidence of Pulmonary Complications|Defined as patients who exhibit a pulmonary (lung) adverse event.|6 Months|||Participants|||Count of Participants
738261|NCT00455312|Secondary|Overall Survival|Overall survival is defined as time from date of transplant to date of death or censored at the date of last documented contact for patients still alive.|1 Year|||Participants|||Count of Participants
738262|NCT00455312|Secondary|Overall Survival|Overall survival is defined as time from date of transplant to date of death or censored at the date of last documented contact for patients still alive.|Day 100|||Participants|||Count of Participants
738263|NCT00455312|Secondary|Incidence of Grade 3-4 Acute Graft Versus Host Disease (GVHD)|Acute Graft-Versus-Host Disease is a severe short-term complication created by infusion of donor cells into a foreign host.|Day 100|||Participants|||Count of Participants
738264|NCT00455312|Secondary|Incidence of Grade 2-4 Acute Graft Versus Host Disease (GVHD)|Acute Graft-Versus-Host Disease is a severe short-term complication created by infusion of donor cells into a foreign host.|Day 100|||Participants|||Count of Participants
738265|NCT00455312|Secondary|Incidence of Late Secondary Malignancies|Defined as patients who have a secondary malignancy (cancer) occurring.|1 Year|||Participants|||Count of Participants
738266|NCT00455312|Secondary|Incidence of Chronic GVHD|Chronic Graft-Versus-Host Disease is a severe long-term complication created by infusion of donor cells into a foreign host.|1 year|||Participants|||Count of Participants
738267|NCT00455312|Secondary|Incidence of Chronic GVHD|Chronic Graft-Versus-Host Disease is a severe long-term complication created by infusion of donor cells into a foreign host.|6 months|||Participants|||Count of Participants
738271|NCT00455429|Primary|Percentage of Participants Who Had at Least 1 Worsening AD Event|Percentage of Participants who had at least 1 Worsening AD Event That did not Meet Flare Criteria were assessed. Worsening of AD that did not meet flare criteria was documented. Flare was considered to be present if either of the following criteria were met: 1) IGA was=2, if IGA on most recent previous assessment was 0; 2) IGA had increased by at least 1 point, if IGA on most recent previous assessment was 1 or more.|Baseline up to Week 6|Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. LOCF method was used.||percentage of participants|||Number
738272|NCT00455429|Primary|Number of Flare Occurrences Per Participant|A flare was considered to be present if the following criteria were met: 1) IGA was greater than or equal to 2, if IGA on most recent previous assessment was 0 or 2) IGA had increased by at least 1 point, if IGA on most recent previous assessment was 1 or more.|Baseline up to Week 6|Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. LOCF method was used.||participants|||Number
738273|NCT00455429|Primary|Percentage of Participants Who Had at Least 1 Flare|Percentage of participants who had at Least 1 Flare while on treatment was assessed. A flare was considered to be present if the following criteria were met: 1) IGA was greater than or equal to 2, if IGA on most recent previous assessment was 0; 2) IGA had increased by at least 1 point, if IGA on most recent previous assessment was 1 or more.|Baseline up to Week 6|Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. LOCF method was used.||percentage of participants|||Number
738274|NCT00455429|Primary|Percentage of Participants Achieving Greater Than (>) or Equal to (=) 25% Reduction in VAS Score for Pruritus at Week 6|VAS consists of 10 centimeter (cm) horizontal line and the words; 0 cm=“No itch” on the left side of the line and the words 10 cm=“Worst possible itch” on the right side of the line. Participants will be instructed to rate the severity of their pruritus within the previous 24 hours by drawing a vertical line across the 10 cm line at the point between “No itch” and “Worst possible itch” which best describes their itching during the preceding 24 hours. Success is defined as an improvement of >=75% from the baseline VAS assessment of pruritus. An improvement of <75% is a failure.|Baseline up to Week 6|Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. LOCF method was used.||percentage of participants|||Number
738275|NCT00455429|Primary|Percentage of Participants Achieving Greater Than (>) or Equal to (=) 50% Reduction in VAS Score for Pruritus at Week 6|VAS consists of 10 centimeter (cm) horizontal line and the words; 0 cm=“No itch” on the left side of the line and the words 10 cm=“Worst possible itch” on the right side of the line. Participants will be instructed to rate the severity of their pruritus within the previous 24 hours by drawing a vertical line across the 10 cm line at the point between “No itch” and “Worst possible itch” which best describes their itching during the preceding 24 hours. Success is defined as an improvement of >=75% from the baseline VAS assessment of pruritus. An improvement of <75% is a failure.|Baseline up to Week 6|Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. LOCF method was used.||percentage of participants|||Number
738276|NCT00455429|Primary|Percentage of Participants Achieving Greater Than (>) or Equal to (=) 75% Reduction in VAS Score for Pruritus at Week 6|VAS consists of 10 centimeter (cm) horizontal line and the words; 0 cm=“No itch” on the left side of the line and the words 10 cm=“Worst Possible Itch” on the right side of the line. Participants will be instructed to rate the severity of their pruritus within the previous 24 hours by drawing a vertical line across the 10 cm line at the point between “No itch” and “Worst possible itch” which best describes their itching during the preceding 24 hours. Success is defined as an improvement of >=75% from the baseline VAS assessment of pruritus. An improvement of <75% is a failure.|Baseline up to Week 6|Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. LOCF method was used.||percentage of participants|||Number
738277|NCT00455429|Primary|Percentage of Participants Achieving Greater Than (>) or Equal to (=) 25% Reduction in EASI Score at Week 6|EASI measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no eruption) to 6 (greater than [>] 90%-100% eruption). The total score is the sum of the four body-region scores, maximum=72, minimum=0, with higher scores reflecting greater disease severity. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score. Success is defined as an improvement of >=25% from the baseline EASI score. An improvement of <25% is considered a failure.|Baseline up to Week 6|Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. LOCF method was used.||percentage of participants|||Number
738278|NCT00455429|Primary|Percentage of Participants Achieving 50% Reduction in EASI Score at Week 6|EASI measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no eruption) to 6 (greater than [>] 90%-100% eruption). The total score is the sum of the four body-region scores, maximum=72, minimum=0, with higher scores reflecting greater disease severity. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score. Success is defined as an improvement of >=50% from the baseline EASI score. An improvement of <50% is considered a failure.|Baseline up to Week 6|Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. LOCF method was used.||percentage of participants|||Number
738279|NCT00455429|Primary|Percentage of Participants Achieving Treatment Response as “Clear” or “Almost Clear “in IGA|Percentage of participants achieving treatment response (decrease) in IGA were assessed. IGA is used to assess AD through a 6-point scale (Range=0-5) where, 0=clear (no inflammatory signs of AD), 1=almost clear (just perceptible erythema & perceptible papulation/infiltration), 2=mild (mild erythema & papulation/infiltration), 3=moderate (moderate erythema & papulation/infiltration), 4=severe (severe erythema & papulation/infiltration) & 5=very severe (severe erythema & papulation/infiltration with oozing/crusting). Success is reduction of IGA to 0 or 1. Failure is reduction of IGA to >=2.|Baseline up to Week 6|Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. LOCF method was used.||percentage of participants|||Number
738280|NCT00455429|Primary|Change From Baseline in Visual Analog Scale (VAS) Score for Pruritus at Week 6|VAS consists of 10 centimeter (cm) horizontal line and the words; 0 cm=“No itch” on the left side of the line and the words 10 cm=“Worst possible itch” on the right side of the line. Participants will be instructed to rate the severity of their pruritus within the previous 24 hours by drawing a vertical line across the 10 cm line at the point between “No itch” and “Worst possible itch” which best describes their itching during the preceding 24 hours.|Baseline and Week 6|Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. LOCF method was used.||millimeter (mm)||Standard Deviation|Mean
738281|NCT00455429|Primary|Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 6|EASI measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no eruption) to 6 (greater than [>] 90%-100% eruption). The total score is the sum of the four body-region scores, maximum=72, minimum=0, with higher scores reflecting greater disease severity. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score.|Baseline and Week 6|Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. LOCF method was used.||units on a scale||Standard Deviation|Mean
738282|NCT00455429|Primary|Investigator's Global Assessment (IGA) Score at Week 6|Participants were reported for IGA. IGA is an overall assessment of Atopic Dermatitis (AD). IGA utilizes a 6-point scale (ranging from 0 to 5): 0=clear (noinflammatory signs of AD), 1=almost clear (just perceptible erythema, and just perceptible papulation/infiltration), 2=mild disease (mild erythema, and mild papulation/infiltration), 3=moderate disease (moderate erythema, and moderate papulation/infiltration), 4=severe disease (severe erythema, and severe papulation/infiltration) and 5=very severe disease (severe erythema, and severe papulation/infiltration with oozing/crusting).|Week 6|Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. Last Observation Carried Forward (LOCF) method was used.||participants|||Number
738283|NCT00455455|Primary|Conjunctival Sensitivity|The detection threshold, the lowest level at which a stimulus to the conjunctiva in a unit of percent CO2 can be detected was measured. Sensitivity is the reciprocal of the detection threshold.|day 7|intent to treat analysis including only participants who had completed the study||percent CO2||Standard Deviation|Mean
738284|NCT00455455|Primary|Conjunctival Sensitivity|The detection threshold, the lowest level at which a stimulus to the conjunctiva in a unit of percent CO2 can be detected was measured. Sensitivity is the reciprocal of the detection threshold.|baseline|intent to treat analysis including only participants who had completed the study||percent CO2||Standard Deviation|Mean
738285|NCT00455455|Secondary|Corneal Staining Grade|A 0-100 grading scale based on the extent of corneal staining (0 none, 100 full area).|day 7|intent to treat analysis including only participants who had completed the study||units on a scale||Standard Deviation|Mean
738286|NCT00455455|Primary|Corneal Sensitivity|The detection threshold, the lowest level at which a stimulus to the cornea in a unit of percent CO2 can be detected was measured. Sensitivity is the reciprocal of the detection threshold.|day 7|intent to treat analysis including only participants who had completed the study||percent CO2||Standard Deviation|Mean
738287|NCT00455455|Secondary|Corneal Staining Grade|A 0-100 grading scale based on the extent of corneal staining (0 none, 100 full area).|baseline|intent to treat analysis including only participants who had completed the study||units on a scale||Standard Deviation|Mean
738288|NCT00455455|Primary|Corneal Sensitivity|The detection threshold, the lowest level at which a stimulus to the cornea in a unit of percent CO2 can be detected was measured. Sensitivity is the reciprocal of the detection threshold.|baseline|intent to treat analysis including only participants who had completed the study||percent CO2||Standard Deviation|Mean
738289|NCT00455650|Secondary|Effects of Mecamylamine and Varenicline Compared With Placebo in Schizophrenia and Control Groups on Working Memory as Assessed by The Visual Spatial Working Memory (VSWM) Task|In the Visual spatial working memory (VSWM), participants were asked to place the cursor where the symbol appeared immediately after its display. For 16 additional trials, participants were asked to identify the symbol location after a 30-second delay. During the delay, participants were distracted by being asked to read aloud words appearing on the screen at 2-second intervals. The outcome of interest in this task were the average distance from the target for immediate and delayed recall There is only one outcome measure time frame because this outcome was analyzed using crossover analyses of covariance (ANCOVA) with drug (mecamylamine vs. varenicline vs. placebo) as a within subject factor, diagnosis (schizophrenia vs. control) as a between subject factor, as well as study period and drug administration sequence as between subject crossover design factors.|Baseline (week 1), week 2, week 3, week 4 analyzed as a single time point|||Distance (in)||Standard Deviation|Mean
738290|NCT00455650|Secondary|Effects of Mecamylamine and Varenicline Compared With Placebo in Schizophrenia and Control Groups on Sustained Attention as Assessed by The N-back Task|The N-back task with 1- and 2-back parametric conditions was used. During the task, a letter was displayed for 1,500 ms every 2 s with a 500 ms isi. Participants were asked to press the “1” key for letters that corresponded to the letter 1 back for the 1-back condition, the “2” key for the 2-back condition, and the “3” key for nontarget letters. Outcome variable presented is hit reaction time There is only one outcome measure time point because this outcome was analyzed using crossover analyses of covariance (ANCOVA) with drug (mecamylamine vs. varenicline vs. placebo) as a within subject factor, diagnosis (schizophrenia vs. control) as a between subject factor, as well as study period and drug administration sequence as between subject crossover design factors.|Baseline (week 1), week 2, week 3, week 4 analyzed as a single time point|||ms||Standard Deviation|Mean
738301|NCT00455858|Secondary|Change in Fasting Plasma Glucose (FPG)|Change in fasting plasma glucose (FPG) from baseline to week 12 and week 20|week 0, week 12, week 20|The analysis was based on Full Analysis Set (FAS) without any imputations. The definition of FAS is: All enrolled subjects exposed to at least one dose of study product and have at least one HbA1c data after 3 months being exposed to the study product.||mg/dL||Standard Deviation|Mean
738379|NCT00456885|Primary|Change in Weight|Change in weight at the end of each treatment period.|16 weeks after the beginning of each treatment|||kilograms||Standard Error|Mean
738380|NCT00456989|Secondary|Response Rate|Data not analyzed, PI left institution|7 years||||||
738291|NCT00455650|Secondary|Effects of Mecamylamine and Varenicline Compared With Placebo in Schizophrenia and Control Groups on Cognitive Interference as Assessed by The Three-card Stroop Task|In the 3-card Stroop Task, 3 cards were presented; the 1st contained color names printed in black ink, the 2nd contained colored patches of ink, the 3rd contained color names printed in incongruously colored ink. Participants were asked to read or name as many items as possible in 45 seconds for each condition. Individuals are asked to identify the color of the ink of a word. They may be distracted by the presence of a word that states another color (i.e. the word “blue” written in green ink would require the answer green).The interference score was calculated by dividing the color-word score by the color score. There is only one outcome measure time point because cognitive outcomes were analyzed using crossover analyses of covariance (ANCOVA) with drug (mecamylamine vs varenicline vs pbo) as a within subject factor, diagnosis (schizophrenia vs. control) as a between subject factor as well as study period and drug administration sequence as between subject crossover design factors|Baseline (week 1), week 2, week 3, week 4 analyzed as a single time point|||score||Standard Deviation|Mean
738292|NCT00455650|Primary|Effects of Mecamylamine and Varenicline Compared With Placebo in Schizophrenia and Control Groups on Prolonged Attention as Assessed With the CPT-IP Hit Reaction Time Variability|The Continuous Performance Test-Identical Pairs, CPT-IP, Version 4.0 was developed and normed for use in people with schizophrenia and normal controls. This task estimates attention by requiring an individual to push a response key when two identical pairs of shapes or numbers are presented in sequence. Stimuli were presented with increasing cognitive load: 2-, 3-, and 4-digit targets. Outcome variables measured included correct hits, hit reaction time (HRT), errors of commission: false alarms and random errors, and the primary outcome, variability, or standard deviation, of hit reaction time, HRT-SD. There is only one outcome measure time point because cognitive outcomes were analyzed using crossover analyses of covariance (ANCOVA) with drug (mecamylamine vs. varenicline vs. placebo) as a within subject factor, diagnosis (schizophrenia vs. control) as a between subject factor, as well as study period and drug administration sequence as between subject crossover design factors.|Baseline (week 0), week 1, week 2 and week 3 as one time point (see outcome measure description)|||ms||Standard Deviation|Mean
738293|NCT00455663|Primary|Number of Patients Surviving Without Relapse/Exacerbation|A relapse was scored (only for patients meeting criteria for remission) if scores on any of the 4 items assessing positive symptoms on the Brief Psychiatric Rating Scale increased a minimum of 2 points to a score of 5 or higher, if the patient was suicidal, if the patient was hospitalized, or if the patient was unable to care for themselves without continual supervision|9 months of treatment 6 months follow up|Number of participants meeting bprs criteria for at least partial remission.scores on 3 of the 4 BPRS psychosis items had to be 4 or lower indicating moderate symptoms only.||participants|||Number
738294|NCT00455663|Primary|Social and Occupational Functioning Scale Score|Scores range from 0 to 100 with higher scores reflecting better functioning. 1 Final score for endpoint created by averaging scores for 9 months of treatment and 6 months of follow up.|1 endpoint ls means combining 9 months of treatment and 6 months follow up|||units on a scale||Standard Error|Mean
738295|NCT00455663|Primary|Positive Symptoms|Positive symptoms subscale of the Brief Psychiatric Rating Scale includes delusions, hallucinations, conceptual disorganization and suspiciousness-Mean score averaging these items, variability 1-7. Higher scores reflect higher level of symptoms. 1 Final score for endpoint created by averaging scores for 9 months of treatment and 6 months of follow up.|1 final endpoint least sq mean combining 9 months of treatment 6 months of follow up|||units on a scale||Standard Error|Least Squares Mean
738296|NCT00455663|Primary|Medication Adherence-pill Count|% medication taken as determined by unannounced pill counts conducted in the home on 2 occasions in each 3 month period. 1 Final score for endpoint created by averaging scores for 9 months of treatment and 6 months of follow up.|1 final score combined for endpoint for 9 months of treatment and 6 months follow up|||percentage of medication taken||Standard Error|Least Squares Mean
738297|NCT00455702|Secondary|Treatment Effects on the Positive Syndrome Subscale of the PANSS|The change from baseline to week 8 on the positive symptom sub-scale of the Positive and Negative Syndrome Scale (PANSS). Total PANSS positive symptom sub-scale scores range from 7-49. The PANSS positive symptom sub-scale is comprised of 7 items rated on a scale of 1-7: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. A score of one on each item 1 absent, 2 is minimal, 3 is mild, 4 is moderate, 5 is moderately severe, 6 is severe, and 7 is extreme. The total score was computed by adding all the items on the sub-scale together. To compute change in scores, week 8 scores were subtracted from baseline scores, resulting in a change score. Higher values equals greater improvement (i.e. week 8 score was lower than baseline score).|Baseline score vs. Week 8 score|One participant from the placebo group was removed from this analysis.||PANSS Positive Subscale Units||Standard Deviation|Mean
738298|NCT00455702|Primary|Main Outcome Measure: The Change From Baseline to Week 8 on the SANS|The change from baseline to week 8 on the scale for the assessment of negative symptoms (SANS) total score. Total SANS scores range from 0-100. The SANS is comprised of 5 subscores: Affective Flattening or Blunting (score range 0-35), Alogia (score range 0-20), Avolition-Apathy (score range 0-15), Anhedonia-Asociality (score range 0-20), and Attention (0-10). For each scale, the higher the score the more prominent the negative symptoms were. The total score was computed by adding all the subscale total scores. To compute change in scores, week 8 scores were subtracted from baseline scores, resulting in a change score. Higher values equals greater improvement (i.e. week 8 score was lower than baseline score).|Baseline score vs. Week 8|||Units on a scale||Standard Deviation|Mean
738299|NCT00455858|Secondary|Occurence of Hypoglycaemic Episodes|Occurence of hypoglycaemic episodes - diurnal and nocturnal - over 20 weeks of treatment.|weeks 0-20|For tabulating the occurence of hypoglycaemic episodes, the safety analysis set of all enrolled subjects exposed to at least one dose of study drug was used. For the adverse events, please refer to details in the adverse events section.||episodes|||Number
738300|NCT00455858|Secondary|Percentage of Subjects Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than 7.0%|Percentage (%) of subjects achieving Glycosylated Haemoglobin A1c (HbA1c) treatment target levels less than 7.0%|week 12, week 20|The analysis was based on Full Analysis Set (FAS) without any imputations. The definition of FAS is: All enrolled subjects exposed to at least one dose of study product and have at least one HbA1c data after 3 months being exposed to the study product.||percentage of participants|||Number
738381|NCT00456989|Primary|Maximum Tolerated Dose and Toxicity Profile|There is no data to report. Data for this trial was not analyzed, the PI left institution.|2 years||||||
738303|NCT00455858|Primary|Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 20|Change in Glycosylated Haemoglobin A1c (HbA1c) from baseline to week 20|week 0, week 20|The analysis was based on Full Analysis Set (FAS) without any imputations. The definition of FAS is: All enrolled subjects exposed to at least one dose of study product and have at least one HbA1c data after 3 months being exposed to the study product.||percentage change in HbA1c||Standard Deviation|Mean
738304|NCT00455962|Primary|LH Peak in Response to Estrogen Positive Feedback|Estradiol levels are consistently higher in African-American vs Caucasian women across the menstrual cycle. This study was designed to determine if African-American women are more sensitive to estrogen positive feedback to generate the preovulatory LH surge using a controlled estrogen infusion paradigm.|5 days of estradiol and progesterone infusion|Healthy African-American and Caucasian women aged 18-35 with regular ovulatory menstrual cycles.||IU/L||Standard Error|Mean
738305|NCT00455975|Secondary|Overall Tolerability and Toxicity of High-dose Bevacizumab|Number of patients treated with high-dose bevacizumab experiencing Grade 3/4, treatment-related toxicities|18 months|All patients treated with Bevacizumab therapy were assessed for Grade 3/4 toxicities||participants|||Number
738306|NCT00455975|Secondary|Objective Response Rate|The number of patients with observed complete response [CR] or partial response [PR]. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR|18 months|||participants|||Number
738307|NCT00455975|Secondary|Overall Survival (OS)|Measured from date of study entry to date of death due to any cause.|18 months|||months||95% Confidence Interval|Median
738308|NCT00455975|Primary|Progression-free Survival|Progression-free survival is measured from Day 1 of study drug administration to disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death on study. Progression is defined in RECIST v1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|18 months (expected)|||months||95% Confidence Interval|Median
738309|NCT00456014|Secondary|Improvement in Scores on the Hamilton Depression Rating Scale - SSRI Phase|Mean % improvement from baseline to end of treatment trial using the 24-item Hamilton Depression Rating Scale. Percent improvement of depressive symptoms was calculated for the 28 completers of the SSRI phase. The higher the score on the 24-item HDRS, the greater the depression severity. Minimum score on the scale is 0, and maximum score is 74. Subscales are not used for this analysis.|Measured at Week 8|Percent improvement of depressive symptoms was calculated for the 28 completers of the SSRI phase. 25 of the 28 SSRI participants completed a trial of escitalopram. 3 of 28 SSRI participants had intolerable side-effects to escitalopram, and were therefore switched to sertraline, and completed a trial of sertraline instead.||% improvement in depression symptoms||Standard Deviation|Mean
738310|NCT00456014|Secondary|Remission of Depressive Symptoms - Tricyclic Phase|Participants who did not achieve remission during the SSRI phase advanced to the tricyclic phase of the study. Participants were treated with either desipramine or nortriptyline. Seven participants started the tricyclic phase. Four completed the tricyclic phase. The completers (n=4) were analyzed for remission status.|Measured over 8 weeks|Depressed participants who did not remit during the SSRI phase advanced to the tricyclic phase of the study. Five participants started treatment with desipramine, one of which also had a trial with nortriptyline. Two participants started tricyclic treatment with nortriptyline.||participants|||Number
738311|NCT00456014|Primary|Remission of Depressive Symptoms|Remission in this study is defined as both a ≥50% decrease in the 24-item Hamilton Depression Rating Scale (HDRS) Score and a final 24-item HDRS score <10. Remission of depressive symptoms was calculated for the 28 completers of the SSRI phase.|Measured at Week 8|"28 of 38 participants completed the SSRI phase. Only those 28 participants were assessed for remission status.
1 participant who is counted as a non-remitter had a spontaneous remission following his MRI."||participants|||Number
738312|NCT00456261|Secondary|Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death||18 months|||months||95% Confidence Interval|Number
738313|NCT00456261|Secondary|Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment||18 months|||percentage of patients||95% Confidence Interval|Number
738314|NCT00456261|Primary|Time to Progression (TTP), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease|Defined as the interval between the date of treatment initiation and the date of progressive disease|18 months|||months||95% Confidence Interval|Median
738315|NCT00456495|Secondary|Evaluating Tumor Destruction or Reduction|To evaluate the efficacy of treatment using comparative slit lamp examinations (anterior segment and ocular adnexal exam) to evaluate tumor volume, from baseline to month 12, and 24. To report on the number of patients with improvement in tumor volume.|2 years|||Participants|||Count of Participants
738316|NCT00456495|Primary|Number of Patients Assessed for Safety and Tolerability|To test the safety and tolerability of subconjunctival injection of ranibizumab in the treatment of malignant conjunctival neoplasia - using comparative slit lamp examination [anterior segment and ocular adnexal examination for adverse events (eg abrasion, melting), visual acuity (number of patients with decrease in visual acuity), and blood pressure at each visit (number of patients with increased blood pressure from baseline), and monthly urinalyis (number of patients with abnormal protein level in urine).|2 years|Analysis was per protocol. Treatment was delivered every 2-4 weeks with good safety and tolerability||participants|||Number
738317|NCT00456508|Secondary|Time to Significant Improvement|"Time to significant improvement in overall response based on the period from 15 minutes after dosing through 4 hrs post dosing. Significant improvement was defined as a response of a lot better or resolved in the overall response assessment."|15 min - 4 hrs post dose after every episode|All efficacy analyses were to be based on the safety population (all treated patients). Only those patients with non-missing severity and response assessment were included in the change in TOS score.||estimated time in minutes||95% Confidence Interval|Median
738465|NCT00457743|Secondary|Progression-Free Survival (PFS)|Progression-Free Survival (PFS) is defined as the time from the date of first dose of study treatment to the date of the first documentation of Progressive Disease (PD) or death.|From the first dose to Progressive Disease or Death|Intent-to-Treat (ITT) population defined as all subjects enrolled in study that receive at least 1 dose of study medication.||Weeks||95% Confidence Interval|Median
738318|NCT00456508|Secondary|Treatment Outcome Score (TOS) at 4 Hrs Post Dosing, Based on the Patient Assessment of Baseline Severity of Symptoms|The Treatment Outcome Score (TOS)is a validated measure of response to therapy. Response assessment for each symptom complex (internal head/neck, stomach/GI, genital/buttocks, external head/neck or cutaneous) was to be weighted based on the severity of symptom complexes at baseline. Severity assessment at baseline was rated on a categorical scale (1=mild, 2=moderate, 3=severe) for symptoms at each affected symptom complex. Response assessment of each symptom complex post-dosing relative to baseline used a scale (100=significant improvement, 50=improvement, 0=same). The weighted values were used to calculate the composite TOS. A TOS greater than 0 denotes an improvement in symptoms compared with baseline severity.|4 hrs post dose after every episode|All efficacy analyses were to be based on the safety population (all treated patients). Only those patients with non-missing severity and response assessment were included in the change in TOS score.||scores on a scale||Standard Deviation|Mean
738319|NCT00456508|Primary|Change From Baseline in Mean Symptom Complex Severity (MSCS) Score at 4 Hrs Post Dosing|Mean Symptom Complex Severity (MSCS) score is a validated point-in-time measure of symptom severity. At baseline and 4 hrs, patients rated the severity on a categorical scale (0=normal, 1=mild, 2=moderate, 3=severe) for symptoms at each affected anatomical location. Ratings were averaged to obtain the MSCS score. A decrease in MSCS score reflected an improvement in symptoms; clinically meaningful improvement was indicated by a reduction in the score of 0.30 or more.|4 hrs post dose after every episode|All efficacy analyses were to be based on the safety population (all treated patients). Only those patients with non-missing severity and response assessment were included in the change in MSCS score.||scores on a scale||Standard Deviation|Mean
738320|NCT00456521|Secondary|Change in Question 19 From 21-Item COE (Control of Eating) Questionnaire|Question 19: Generally, how difficult has it been to control your eating? Scoring: 0=not at all difficult; 100=extremely difficult|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||units on a scale||Standard Error|Least Squares Mean
738321|NCT00456521|Secondary|Change in Food Craving Inventory Carbohydrates Subscale Scores|The Food Craving Inventory is a 33-item self-report measure designed to assess specific food cravings and is organized into 4 subscales (high fats, sweets, carbohydrates/starches, and fast-food fats). A craving was defined as an intense desire to consume a particular food (or food type) that was difficult to resist over the past month. Subjects rated their frequency of cravings for each of the 33 items using a 5-point scale, where 1=never, 2=rarely, 3=sometimes, 4=often, and 5=always. The carbohydrates subscale consisted of 8 items and the score ranges from 8 (better outcome) to 40 (worse outcome).|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||units on a scale||Standard Error|Least Squares Mean
738322|NCT00456521|Secondary|Change in Food Craving Inventory Sweets Subscale Scores|The Food Craving Inventory is a 33-item self-report measure designed to assess specific food cravings and is organized into 4 subscales (high fats, sweets, carbohydrates/starches, and fast-food fats). A craving was defined as an intense desire to consume a particular food (or food type) that was difficult to resist over the past month. Subjects rated their frequency of cravings for each of the 33 items using a 5-point scale, where 1=never, 2=rarely, 3=sometimes, 4=often, and 5=always. The sweets subscale consisted of 8 items and the score ranges from 8 (better outcome) to 40 (worse outcome).|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||units on a scale||Standard Error|Least Squares Mean
738323|NCT00456521|Secondary|Change in IDS-SR Total Scores|IDS-SR= Inventory of Depressive Symptoms-Subject Rated IDS-SR total score is based on 30 items. The total score can range from 0-84, with 0 being no depressive symptoms and 84 being very severe depressive symptoms. A total score ≤ 13 indicates no depression.|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||units on a scale||Standard Error|Least Squares Mean
738324|NCT00456521|Secondary|Change in Diastolic Blood Pressure||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||mmHg||Standard Error|Least Squares Mean
738325|NCT00456521|Secondary|Change in Systolic Blood Pressure||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||mmHg||Standard Error|Least Squares Mean
738326|NCT00456521|Secondary|Change in Fasting LDL Cholesterol||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||mg/dL||Standard Error|Least Squares Mean
738327|NCT00456521|Secondary|Change in Fasting Blood Glucose Levels||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||mg/dL||Standard Error|Least Squares Mean
738328|NCT00456521|Secondary|Change in High-sensitivity C Reactive Protein (Hs-CRP) Levels, Using Log-transformed Data||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||percent change||95% Confidence Interval|Least Squares Mean
738329|NCT00456521|Secondary|Change in HOMA-IR Levels, Using Log-transformed Data|HOMA-IR= Homeostasis Model Assessment-Insulin Resistance|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||percent change||95% Confidence Interval|Least Squares Mean
738785|NCT00458211|Secondary|Clinical Global Impression (CGI) Scores the Evaluator's Overall Impression of Severity (CGI-S) or Change (CGI-I) in Illness.|CGI-S scores from 1 = normal to 7 = most extremely ill|8 weeks|17 Buffalo subjects and 19 Bronx subjects||score on scale||Standard Deviation|Mean
738330|NCT00456521|Secondary|Change in IWQOL-Lite Total Scores|IWQOL-Lite= Impact of Weight on Quality of Life-Lite Questionnaire Total score is based on a scale from 0 to 100, with 0 representing the poorest and 100 the best quality of life and where a score of 71-79 indicates moderate impairment|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||units on a scale||Standard Error|Least Squares Mean
738331|NCT00456521|Secondary|Change in Fasting HDL Cholesterol Levels||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||mg/dL||Standard Error|Least Squares Mean
738332|NCT00456521|Secondary|Change in Fasting Insulin Levels, Using Log-transformed Data||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||percent change||95% Confidence Interval|Least Squares Mean
738333|NCT00456521|Secondary|Change in Fasting Triglycerides Levels, Using Log-transformed Data||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||percent change||95% Confidence Interval|Least Squares Mean
738334|NCT00456521|Secondary|Change in Waist Circumference||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||cm||Standard Error|Least Squares Mean
738335|NCT00456521|Secondary|Body Weight- Proportion of Subjects With ≥10% Decrease||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||percentage of participants||95% Confidence Interval|Number
738336|NCT00456521|Primary|Co-primary: Body Weight- Proportion of Subjects With ≥5% Decrease||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||percentage of participants||95% Confidence Interval|Number
738337|NCT00456521|Primary|Co-primary: Body Weight- Mean Percent Change||Baseline, 56 weeks|Modified ITT (Full Analysis Set): Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||percentage of body weight||Standard Error|Least Squares Mean
738338|NCT00456547|Secondary|Antithrombin III Levels at 2 Hours Post Delivery|Antithrombin III is a glycoprotein and is the major inhibitor of thrombin and other activated clotting factors, including factors IX, X, XI, and XII, the cofactor through which heparin exerts its effect. We hypothesized that women with continued bleed following delivery and require a hysterectomy will demonstrate a greater reduction in antithrombin III that women undergoing cesarean delivery.|2 hours after delivery|||percentage of normal antithrombin III||Standard Deviation|Mean
738339|NCT00456547|Secondary|Plasminogen Levels 2 Hours After Delivery|Plasminogen is converted to plasmin when the coagulation system is activated. We hypothesized that plasminogen should be decrease more in women with continued bleeding following delivery requiring hysterectomy will demonstrated a greater decrease in plasminogen than following cesarean delivery.|2 hours after delivery|||mg/dL||Standard Deviation|Mean
738340|NCT00456547|Secondary|Platelet Counts at 2 Hours After Delivery|Platelets are decreased in subjects with consumptive coagulopathies which is a pathological activation of coagulation (blood clotting) mechanisms that happens in response to a variety of diseases. We hypothesized that women who require hysterectomy for postpartum bleeding are more likely to have decreased platelet counts than matched controls that underwent cesarean delivery.|2 hours after delivery|||platelets (*1000 per liter)||Standard Deviation|Mean
738341|NCT00456547|Primary|Fibrinogen Level at 2 Hours After Delivery|Fibrinogen level decrease is a marker of consumptive coagulation which is is a pathological activation of coagulation (blood clotting) mechanisms that happens in response to a variety of diseases or stimulus. We hypothesized that women with excessive bleeding following delivery who require a hysterectomy are more likely to exhibit lower levels of fibrinogen and a consumptive coagulopathy than women following cesarean delivery who do not bleed.|2 hours after delivery|||mg/dL||Standard Deviation|Mean
738342|NCT00456599|Secondary|Overall Survival|Percent overall survival was calculated for all evaluable patients.|5 years|Of the 71 eligible patients, 68 were evaluable for overall response (1 patient was removed from study during cycle 1 for noncompliance, and 2 additional patients withdrew for reasons not related to toxicity or progression).||months||95% Confidence Interval|Median
738343|NCT00456599|Secondary|Time to Treatment Failure|Median time for disease recurrence after surgery.|2 years|43 patients underwent resection. 41 of the 43 had R0/R1 (surgical margin status) resection. Patients with R02 surgical margins (portions of the tumor visible to the naked eye were not removed) were not included in the analysis.||months||Full Range|Median
738344|NCT00456599|Primary|Two-year Disease Free Survival.|The percent of patients alive and disease-free at two years.|two years|43 patients underwent resection. 41 of the 43 had R0/R1 (surgical margin status) resection. Patients with R02 surgical margins (portions of the tumor visible to the naked eye were not removed) were not included in the analysis.||percentage of patients||95% Confidence Interval|Number
738345|NCT00456612|Primary|Progression Free Survival||consent to prgression or death||||||
738346|NCT00456612|Secondary|Response, Median Time to Tumor Progression,Overall Survival, Percent Overall Survival at 1 Year Will be Tabulated.||1year||||||
738347|NCT00456612|Primary|The Percent Progression -Free Survival at 6 Months Will be Tabulated||6 months||||||
738348|NCT00456625|Secondary|Number of Participants Reporting Any Serious Adverse Events (SAEs).|"An SAE is any untoward medical occurrence that:
results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above."|Up to 1 month after the challenge dose.|||participants|||Number
738349|NCT00456625|Secondary|Occurrence, Intensity and Relationship to Vaccination of Unsolicited Adverse Events (AEs)|"An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
An AE is considered severe if it prevents normal, everyday activities."|During the 31-day follow-up period after the challenge dose of hepatitis B vaccine.|||participants|||Number
738350|NCT00456625|Primary|Number of Participants With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Specific Cut-off Values|The cut-off values assessed include: ≥ 3.3 Milli International Units per Milliliter (mIU/mL), ≥ 10 mIU/mL, and ≥ 100 mIU/mL.|One month after the hepatitis B vaccine challenge dose|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity (including all evaluable subjects who had received the challenge dose of hepatitis B vaccine and for whom immunogenicity data were available at the post-hepatitis B vaccine challenge dose timepoint).||participants|||Number
738351|NCT00456755|Secondary|Quality of Life (Difference Between Baseline and Week 4)|SF-36 QOL questionnaire administrated before and after treatment. It has eight domains: general health (GH), physical functioning (PF), social functioning (SF), role limitation caused by physical problems (RP), bodily pain (BP), role limitations caused by emotional problem (RE), mental health (MH), and vitality (VT). Each domain was started from 0 (worst health) to 100 (best health).|4 week|ITT||Unit Score||Standard Deviation|Mean
738352|NCT00456755|Primary|Allergic Rhinitis Symptom Score Including Rhinorrhea, Nasal Obstruction, Sneezing, Itchy Nose and Itchy Eyes at Week 4|The severity of PAR was evaluated by means of a daily symptom diary chart. Patients were instructed to grade retrospectively everyday before bedtime, their generalwell-being, nasalsymptoms (nasal blockage, rhinorrhea, nose itching, sneezing) and non-nasal symptoms(itching eyes, tearing eyes, redness of eyes, itching of ears or palate) on the diary chart. A 4-point severity scale from no symptoms (0), mild (1), moderated (2) to severe (3) was used.|4 week|||Unit Score||Standard Deviation|Mean
738353|NCT00456807|Primary|Correlation of Anti-HPV-16 and Anti-HPV-18 Antibodies in Serum and in Cervical Secretion (CVS) Samples|Pearson coefficients of correlation between serum and CVS for anti-HPV-16 and anti-HPV-18 titers standardized for total IgG were calculated.|At Month 12 and Month 18 after first vaccination|Analysis was performed on the Total Vaccinated Cohort, only on those subjects from the Cervarix group with CVS sample results available.||correlation coefficient|||Number
738354|NCT00456807|Primary|Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) Immunoglobulin G (IgG) Antibodies|Titers given as Geometric Mean Titers (GMTs). An arbitrary value of 0 was given for subjects with antibody concentration below the limit of quantification.|At Month 12 and Month 18 after first vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data. None of the subjects in the Placebo Group had detectable antibodies against HPV-16 at Months 12 and 18 and against HPV-18 at Month 12.||Titer||95% Confidence Interval|Geometric Mean
738355|NCT00456807|Primary|Titers of Anti-HPV-16 and Anti-HPV-18 Antibodies|Titers are presented as Geometric Mean Titers (GMTs).|At Month 12 and Month 18 after first vaccination|Analysis was performed on subjects from the Total Vaccinated Cohort with available results.||Titer||95% Confidence Interval|Geometric Mean
738356|NCT00456807|Primary|Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations Above Pre-defined Cut-off Values|Cut-off values assessed include 8 enzyme-linked immunosorbent assay units Per Milliliter (EL.U/mL)for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.|At Month 12 and Month 18 after first vaccination|Analysis was performed on subjects from the Total Vaccinated Cohort with available results.||Subjects|||Number
738357|NCT00456807|Primary|Number of B-cells Per Million Showing a Specific Memory Response for HPV-16 and HPV-18|"The geometric mean and 95% confidence interval of the number of HPV-16 and HPV-18 specific memory B-cells is reported per million of B-cells.
An arbitrary value of 0 was given for subjects with antibody concentration below the limit of quantification."|At Month 12 and Month 18 after first vaccination|Analysis was performed on subjects from the Total Vaccinated Cohort with available results.||cells per million B-cells||95% Confidence Interval|Geometric Mean
738358|NCT00456807|Primary|Number of Cytokine-positive CD4/CD8 Cells Per Million in Tests Producing at Least 2 Different Cytokines|The geometric mean and 95% confidence interval of the number of Human Papilloma Virus type 16 (HPV-16) and HPV-18 specific CD4 and CD8 cells producing at least 2 different cytokines is reported per million of CD4 or CD8 T-cells, respectively.|At Month 12 and Month 18 after first vaccination|Analysis was performed on subjects from the Total Vaccinated Cohort with available results.||cells per million CD4/CD8 T-cells||95% Confidence Interval|Geometric Mean
738359|NCT00456846|Secondary|Number of Participants With Treatment-Emergent Adverse Events|Count of study participants who had at least one treatment-emergent adverse event (TEAE) defined as any adverse event that began or worsened in grade after the start of study drug through 30 days after the last dose of study drug. The National Cancer Institute (NCI)'s Common Terminology Criteria for AEs (CTCAE) was used to grade AE severity: severity grade 3= severe and undesirable AE. Severity grade 4= life-threatening or disabling AE. Severity grade 5 = death.|Day 1 to Day 940|Treated Population: The Treated population consisted of all enrolled participants who received at least one dose of study drug.||participants|||Number
738360|NCT00456846|Secondary|Number of Participants Experiencing Dose Reductions, Interruptions, or Dose Delays of Study Drug|The number of participants with dose reductions, dose interruptions and dose delays that occurred during the treatment period. Dose reductions, interruptions and delays are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities.|Day 1 of study drug to Day 940; data cut off 31 May 2013|Treated Population: The Treated population consisted of all enrolled participants who received at least one dose of study drug.||participants|||Number
738361|NCT00456846|Secondary|Patient Survival|Participant survival was the time from the first dose of study drug to participant death from any cause. Participants who did not die were censored at the last known time the participant was alive.|Study start until death, or until data cut-off 31 May 2013; up to 61 months|Treated Population: The Treated population consisted of all enrolled participants that received at least one dose of study drug.||months||95% Confidence Interval|Median
738477|NCT00457743|Secondary|Trough Plasma Concentration (Ctrough) of SU-012262|Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration|Day 14, 28 of Cycle 1; Day 1, 14, 28 of Cycles 2-4|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacokinetic analysis.
n= Number of subjects with analyzable data."||ng/mL||Standard Deviation|Mean
738362|NCT00456846|Secondary|Duration of Response Based on Investigator Assessment|Duration of response was defined as progression-free survival in responders, i.e. as the time between the start of a complete response (CR) or partial response (PR) and the start of progressive disease (PD) or patient death from any cause, whichever occurred first. Participants who did not have progression or had not died were censored at the last known time the participant was progression free. Participants who had initiated other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated. Complete response (CR) and partial response (PR) were defined in outcome #1. Progressive disease was defined as at least a 20% increase in the sum of the longest diameters of target lesions; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion. Response was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST).|Initial response until disease progression; or until data cut off 31 May 2013; up to 61 months|Treated Population: The Treated population consisted of all enrolled participants that received at least one dose of study drug.||months||95% Confidence Interval|Median
738363|NCT00456846|Secondary|Duration of Response Based on Independent Reviewer Assessment|Duration of response was defined as progression-free survival in responders, i.e. as the time between the start of a complete response (CR) or partial response (PR) and the start of progressive disease (PD) or patient death from any cause, whichever occurred first. Participants who did not have progression or had not died were censored at the last known time the participant was progression free. Participants who had initiated other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated. CR and PR were defined in outcome #1. Progressive disease was defined as at least a 20% increase in the sum of the longest diameters of target lesions; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion. Response was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST).|Initial response until disease progression; or until data cut off 31 May 2013; up to 61 months|Treated Population: The Treated population with a confirmed complete response or partial response.||months||95% Confidence Interval|Median
738364|NCT00456846|Secondary|Progression-free Survival (PFS)|PFS was defined as the time from the first dose of study drug to the start of progression or patient death (any cause), whichever occurred first. Participants who did not have progression or did not die were censored at the last known time the participant was progression free. Participants who initiated other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated.|Study start until disease progression, death, or up to data cut off of 31 May 2013; up to 61 months|Treated Population: The Treated population consisted of all enrolled participants who received at least one dose of study drug.||months||95% Confidence Interval|Median
738365|NCT00456846|Secondary|Percentage of Participants With Disease Control|Disease control was defined as stable disease (SD) for ≥ 16 weeks or complete response (CR) or partial response (PR). Response was evaluated by the Investigator and by an independent reviewer using Response Evaluation Criteria in Solid Tumors (RECIST) guidelines version 1.0. See Outcome #1 for definitions of CR and PR. RECIST defines SD for target lesions as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, no occurrence of progression disease for non-target lesions, and no new lesions.|Every 8 weeks from study start until disease progression; Up to 61 months|Treated Population: The Treated population consisted of all enrolled participants who received at least one dose of study drug.||percentage of participants||95% Confidence Interval|Number
738366|NCT00456846|Primary|Percentage of Participants With Objective Confirmed Complete or Partial Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 Based on Investigator and Independent Reviewers|Overall response rate (ORR) is complete response (CR) + partial response (PR). Complete response (CR): The disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation. All sites must be assessed, including non-measurable sites, such as effusions, or markers. Disappearance of all non-target lesions. The normalization of tumor marker level confirmed at least 4 weeks after initial documentation. Partial response (PR): At least a 30% decrease in the sum of the longest diameters of target lesions, taking as a reference the baseline sum of the longest diameters confirmed at least 4 weeks after initial documentation. PR is also recorded when all measurable disease has completely disappeared, but a non-measurable component (i.e., ascites) is still present but not progressing. As well as persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits|Every 8 weeks from study start until disease progression; Up to 61 months|Treated Population: The Treated population consisted of all enrolled participants who received at least one dose of study drug.||percentage of participants||95% Confidence Interval|Number
738367|NCT00456885|Secondary|REE|Resting Energy Expenditure|16 weeks from the start of each treatment period.|||Kilocalories||95% Confidence Interval|Mean
738368|NCT00456885|Secondary|HOMA Score||16 weeks from the start of each treatment period.|||Ratio fasting glucose to insulin||95% Confidence Interval|Mean
738369|NCT00456885|Secondary|Change in Two Hour Glucose||16 weeks from the start of each treatment period.|||mg/dl||95% Confidence Interval|Mean
738370|NCT00456885|Secondary|Change in Fasting Glucose||16 weeks from the start of each treatment period.|||mg/dl||95% Confidence Interval|Mean
738371|NCT00456885|Secondary|Change in Insulin||16 weeks from the start of each treatment period.|||microunits per liter||95% Confidence Interval|Mean
738372|NCT00456885|Secondary|Adiponectin||16 weeks after the beginning of each treatment|||microgram per ml||95% Confidence Interval|Mean
738373|NCT00456885|Secondary|Diastolic Blood Pressure||16 weeks after the beginning of each treatment|||mm of mercury||95% Confidence Interval|Mean
738374|NCT00456885|Secondary|Changes in Leptin||16 weeks from the start of each treatment period.|||ng/ml||95% Confidence Interval|Mean
738375|NCT00456885|Secondary|Changes in Body Composition|Per cent body body fat was assessed using bio-electrical impedance with a BIA; RJL System Quantum II Bioelectrical Body Composition Analyzer. The data is reported as per cent body fat.|16 weeks after the beginning of each treatment|||per cent||95% Confidence Interval|Mean
738376|NCT00456885|Secondary|Systolic Blood Pressure|Blood pressure was measured using a Dynamap automated monitoring device. The change is reported as the blood pressure measured at the beginning of the treatment group and after 16 weeks. We are reporting the change in the systolic blood presssure recorded.|16 weeks after the beginning of each treatment|||mm of mercury||95% Confidence Interval|Mean
738377|NCT00456885|Secondary|Change in Waist Circumference||16 weeks from the start of each treatment period.|||centimeters||95% Confidence Interval|Mean
738382|NCT00457002|Secondary|Number of Participants With Liver-Related Elevations During the Treatment Period in Treated Participants|Liver function tests: Alanine aminotransferase (ALT) U/L; Aspartate aminotransferase (AST) U/L; Alkaline phosphatase U/L; Total Bilirubin (TBili) mg/dL. Elevations consist of >3*Upper Limit of Normal (ULN) for ALT and AST and elevation of >2*ULN for Bilirubin.|Day 1 to last dose of study drug plus 2 days|Participants who received at least one dose of study drug and had available laboratory measurements.||participants|||Number
738383|NCT00457002|Secondary|Number of Participants With Events of Special Interest for Liver Function and Neurology During Treatment Period in Treated Participants With Available Measurements|Special interest include: liver function test increases, AEs related to liver function, and neurologic AEs. Treatment Period includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drug when summarizing AEs and through 30 days after the last dose when summarizing SAEs.|Day 1 to last dose of study drug plus 2 days (AEs) and plus 30 days (SAEs)|Participants who received at least one dose of study drug, and had available laboratory results associated with the event and treatment group.||participants|||Number
738384|NCT00457002|Secondary|Incidence of Events of Special Interest of Adjudicated Myocardial Infarction, Stroke, and Thrombocytopenia During the Treatment Period in Treated Participants|Events of Special Interest include: adjudicated thrombocytopenia, adjudicated myocardial infarction (MI), adjudicated stroke, and adjudicated MI or stroke. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). Treatment Period includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drugs.|Day 1 to last dose of study drug plus 2 days|MI and thrombocytopenia categories: participants who received at least one dose of study drug. MI or stroke category: treated participants except those who did not have MI and had an inadequate assessment for stroke. Stroke category: treated participants except those with an inadequate assessment for stroke during the treatment period.||Event Rate (%)||95% Confidence Interval|Number
738385|NCT00457002|Secondary|Number of Participants With Marked Abnormalities in Glucose, Creatine Kinase, Uric Acid, and Total Protein Laboratory Tests During the Treatment Period in Treated Participants|Creatine kinase High: >5*ULN Units/Liter (U/L); Total Protein High/Low: < 0.9 *LLN or > 1.1*ULN, or if PreRx < LLN then use 0.9* PreRx or > ULN if PreRx > ULN then use 1.1 *PreRx or <LLN; Uric acid High: > 1.5* ULN, or if PreRx > ULN then use > 2 *PreRx. Glucose Fasting: <0.9*LLN or > 1.5*ULN or if PreRx < LLN then use < 0.8*PreRx or > ULN, if PreRx > ULN then use >2.0*PreRx. Samples obtained at Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) ± 2days.|Day 1 to last dose of study drug plus 2 days|Participants who received at least one dose of study drug, had a pre-therapy value, and had a value on the day specified were analyzed.||participants|||Number
738386|NCT00457002|Secondary|Number of Participants With Marked Abnormalities in Kidney and Liver Function Laboratory Tests During the Treatment Period in Treated Participants|Blood urea nitrogen (BUN), milligrams/deciliter (mg/dL), units per liter (U/L). BUN mg/dL > 1.5*ULN; Creatinine mg/dL: > 1.5*ULN; Alanine aminotransferase (ALT) U/L: > 3*ULN; Aspartate aminotransferase (AST) U/L: > 3*ULN; Alkaline phosphatase U/L: > 2*ULN; Bilirubin Direct mg/dL: > 1.5*ULN; Bilirubin Total mg/dL: > 2*ULN. Samples for laboratories obtained at Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days.|Day 1 to last dose of study drug plus 2 days|Participants who received at least one dose of study drug, had a pre-therapy value, and had a value on the day specified were analyzed.||participants|||Number
738387|NCT00457002|Secondary|Number of Participants With Marked Abnormalities in Electrolyte Laboratory Tests During Treatment Period in Treated Participants|Bicarbonate milliequivalents/Liter (mEq/L) Low/High: < 0.75*LLN or > 1.25*ULN, or if PreRx < LLN then use < 0.75* PreRx or > ULN if PreRx > ULN then use > 1.25*PreRx or < LLN; Serum Calcium mg/dL Low/High: < 0.8*LLN or > 1.2*ULN, or if PreRx < LLN then use < 0.75*PreRx or > ULN if PreRx > ULN then use > 1.25*PreRx or < LLN; Serum Chloride mEq/L: < 0.9*LLN or > 1.1*ULN, or if PreRx < LLN then use < 0.9*PreRx or > ULN if PreRx > ULN then use > 1.1*PreRx or < LLN; Serum Potassium mEq/L: < 0.9*LLN or > 1.1*ULN, or if PreRx < LLN then use < 0.9*PreRx or > ULN if PreRx > ULN then use > 1.1*PreRx or < LLN; Serum Sodium mEq/L: < 0.95*LLN or > 1.05*ULN, or if PreRx < LLN then use < 0.95*PreRx or > ULN if PreRx > ULN then use > 1.05*PreRx or < LLN. Samples obtained at Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days.|Day 1 to last dose of study drug plus 2 days|Participants who received at least one dose of study drug, had a pre-therapy value, and had a value on the day specified were analyzed.||participants|||Number
738388|NCT00457002|Secondary|Number of Participants With Marked Abnormalities in Hematology Laboratory Tests During Treatment Period in Treated Participants|Lower limit of normal (LLN). Upper limit of normal (ULN). Pre-therapy (PreRx). Absolute (Abs) neutrophil count, bands + neutrophils (ANC). Cells per microliter (c/µL). Grams per deciliter (g/dL). Cells per Liter (c/L). Millimeter (MM). Absolute (Abs). Hemoglobin: >2 g/dL decrease compared to PreRx value or value <=8 g/dL; Hematocrit: <0.75*PreRx; Erythrocytes: <0.75*PreRx c/µL; Leukocytes: <0.75*LLN or > 1.25*ULN, if PreRx <LLN then use <0.8*PreRx or >ULN, if PreRx >ULN then use >1.2*PreRx or < LLN; Platelet count: < 100*10^9 c/L; ANC: < 1.00*10^3 c/µL; Abs eosinophils: > 0.75*10^3 c/µL; Abs Basophils: > 400/MM^3; Abs Monocytes > 2000/MM^3; Abs Lymphocytes: < 0.750*10*3 c/ µL or > 7.5*10^3 c/ µL. Samples were obtained at Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days.|Day 1 to last dose of study drug plus 2 days|Participants who received at least one dose of study drug, had a pre-therapy value, and had a value on the day specified were analyzed.||participants|||Number
738389|NCT00457002|Secondary|Mean Change From Baseline in Heart Rate in Treated Participants|Heart Rate was obtained during Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days. Heart rate was measured in beats per minute (bpm) and could have been taken with participants either sitting, standing, or supine.|Day 1 to last dose of study drug plus 2 days|Participants who received at least one dose of study drug, had a baseline value, and had a value on the day specified were analyzed.||bpm||Standard Deviation|Mean
738478|NCT00457743|Secondary|Trough Plasma Concentration (Ctrough) of SU-011248|Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration|Day 14, 28 of Cycle 1; Day 1, 14, 28 of Cycles 2-4|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacokinetic analysis.
n= Number of subjects with analyzable data."||ng/mL||Standard Deviation|Mean
738390|NCT00457002|Secondary|Mean Change From Baseline in Systolic Blood Pressure in Treated Participants During Treatment Period|Systolic blood pressure was obtained during Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days. Blood pressure was measured in millimeters of mercury (mmHg) and could have been taken either sitting, standing, or supine.|Day 1 to last dose of study drug plus 2 days|Participants who received at least one dose of study drug, had a baseline value, and had a value on the day specified were analyzed.||mmHg||Standard Deviation|Mean
738391|NCT00457002|Secondary|Mean Change From Baseline in Diastolic Blood Pressure in Treated Participants During Treatment Period|Diastolic blood pressure was obtained during Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days. Blood pressure was measured in millimeters of mercury (mmHg) and could have been taken with the participant either sitting, standing, or supine.|Day 1 to last dose of study drug plus 2 days|Participants who received at least one dose of study drug, had a baseline value, and had a value on the day specified were analyzed.||mmHg||Standard Deviation|Mean
738392|NCT00457002|Secondary|Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Bleeding AEs, Deaths, and Discontinuations Due to AEs During the Treatment Period in Treated Participants|Treatment Period=includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drugs for AEs, and 30 days after last dose of study drugs for SAEs and deaths.|Day 1, first dose of study drug, to last dose of study drug plus 2 days (AEs), plus 30 days (SAEs, Deaths)|Participants who received at least one dose of study drug were analyzed (As Treated population).||participants|||Number
738393|NCT00457002|Secondary|Incidence of Adjudicated Asymptomatic Proximal DVT With Onset During the Intended Treatment Period|A bilateral compression ultrasound (CUS) was performed between Days 5 and 14 for detection of asymptomatic proximal DVT unless a symptomatic VTE was confirmed prior. CUS was also performed on Day 30 ± 2 except for those participants who had a confirmed symptomatic VTE or proximal asymptomatic DVT prior to that time. Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Intended Treatment Period|Those randomized with adjudicated and evaluable ultrasound at the end of the intended treatment period; for those with a suspected symptomatic event, the adjudication result was not inadequate; includes all those randomized who have an adjudicated event associated with the endpoint during Intended Treatment.||Event Rate (%)||95% Confidence Interval|Number
738394|NCT00457002|Primary|Incidence of All Bleeding During the Treatment Period in Treated Participants|Bleeding was adjudicated by an ICAC using criteria from the ISTH. Treatment Period=includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drugs, for bleeding endpoints. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Day 1, first dose of drug to last dose of drug plus 2 days|Participants who received at least one dose of study drug were analyzed (As Treated population). Participants were categorized to the group to which they were randomized, unless the same incorrect treatment was received throughout the study; in such case, the As Treated were equal to the treatment received.||Event Rate (%)||95% Confidence Interval|Number
738395|NCT00457002|Primary|Incidence of Composite of Major or Clinically Relevant Non-Major (CRNM) Bleeding During the Treatment Period in Treated Participants|Bleeding was adjudicated by an ICAC using criteria from the ISTH. Major bleeding: acute clinically overt bleeding: associated with a fall in hemoglobin of 2 g/dL or more, or leading to a transfusion of 2 or more units of packed red blood cells or 1000 mL or more of whole blood, or bleeding in a critical site or bleeding which is fatal. CRNM bleeding: acute clinically overt bleeding compromising hemodynamics; leading to hospitalization; traumatic subcutaneous hematoma; intramuscular hematoma; epistaxis that lasted for more than 5 minutes, was repetitive or led to an intervention; spontaneous gingival bleeding; spontaneous hematuria; macroscopic gastrointestinal hemorrhage; rectal blood loss. Treatment Period=onset from first dose of study drug through 2 days after last dose of study drugs. Incidence: Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Day 1, first dose of study drug, to last dose of study drug plus 2 days|Participants who received at least one dose of study drug were analyzed (As Treated population). Participants were categorized to the group to which they were randomized, unless the same incorrect treatment was received throughout the study; in such case, the As Treated were equal to the treatment received.||Event Rate (%)||95% Confidence Interval|Number
738396|NCT00457002|Primary|Incidence of Clinically Relevant Non-Major (CRNM) Bleeding During the Treatment Period in Treated Participants|Bleeding was adjudicated by an ICAC using criteria from the ISTH. CRNM bleeding: acute clinically overt bleeding compromising hemodynamics; leading to hospitalization; traumatic subcutaneous hematoma; intramuscular hematoma; epistaxis that lasted for more than 5 minutes, was repetitive or led to an intervention; spontaneous gingival bleeding; spontaneous hematuria; macroscopic gastrointestinal hemorrhage (including at least 1 episode of melena or hematemesis, if clinically apparent with positive results on a fecal occult-blood test); rectal blood loss. Treatment Period=includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drugs for bleeding endpoints. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Day 1, first dose of study drug, to last dose of study drug plus 2 days|Participants who received at least one dose of study drug were analyzed (As Treated population). Participants were categorized to the group to which they were randomized, unless the same incorrect treatment was received throughout the study; in such case, the As Treated were equal to the treatment received.||Event Rate (%):||95% Confidence Interval|Number
740207|NCT00462722|Secondary|Bone Turnover Markers||Baseline, and after 4.5 & 9 months of training|Because of the costs associated with the assays and data analysis of bone turnover markers, we did not pursue data collection after learning of the primary outcomes (changes in BMD).|||||
738397|NCT00457002|Primary|Incidence of Major Bleeding During the Treatment Period in Treated Participants|Major bleeding was adjudicated by an ICAC using criteria from the International Society on Thrombosis and Hemostasis (ISTH) and was defined as acute clinically overt bleeding: associated with a fall in hemoglobin of 2 grams per deciliter (g/dL) or more, or leading to a transfusion of 2 or more units of packed red blood cells or 1000 milliliters (mL) or more of whole blood, or bleeding in a critical site or bleeding which is fatal. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Day 1, first dose of study drug, to last dose of study drug plus 2 days|Participants who received at least one dose of study drug were analyzed (As Treated population). Participants were categorized to the group to which they were randomized, unless the same incorrect treatment was received throughout the study; in such case, the As Treated were equal to the treatment received.||Event Rate (%)||95% Confidence Interval|Number
738398|NCT00457002|Secondary|Incidence of Adjudicated Symptomatic Proximal DVT With Onset During the Intended Treatment Period|Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. A bilateral compression ultrasound (CUS) was performed between Days 5 and 14 for detection of asymptomatic proximal DVT unless a symptomatic VTE was confirmed prior. CUS was also performed on Day 30 ± 2 except for those participants who had a confirmed symptomatic VTE or proximal asymptomatic DVT prior to that time. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Intended Treatment Period|Randomized participants, except those with an inadequate assessment for symptomatic events that are part of the endpoint during the intended treatment, were analyzed.||Event Rate (%)||95% Confidence Interval|Number
738399|NCT00457002|Secondary|Incidence of Adjudicated Symptomatic Distal DVT With Onset During the Intended Treatment Period|Events were adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Intended Treatment Period|Randomized participants, except those with an inadequate assessment for symptomatic events that are part of the endpoint during the intended treatment period, were analyzed.||Event Rate (%)||95% Confidence Interval|Number
738400|NCT00457002|Secondary|Incidence of Adjudicated Proximal DVT With Onset During the Intended Treatment Period|Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. A bilateral compression ultrasound (CUS) was performed between Days 5 and 14 for detection of asymptomatic proximal DVT unless a symptomatic VTE was confirmed prior. CUS was also performed on Day 30 ± 2 except for those participants who had a confirmed symptomatic VTE or proximal asymptomatic DVT prior to that time. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Intended Treatment Period|Those randomized with adjudicated and evaluable ultrasound at the end of the intended treatment period; for those with a suspected symptomatic event, the adjudication result was not inadequate; includes all those randomized who have an adjudicated event associated with the endpoint during Intended Treatment.||Event Rate (%)||95% Confidence Interval|Number
738401|NCT00457002|Secondary|Incidence of Adjudicated Symptomatic DVT With Onset During the Intended Treatment Period|Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Intended Treatment Period|Randomized participants except those with an inadequate assessment for symptomatic events that are part of the endpoint during the intended treatment were analyzed.||Event Rate (%)||95% Confidence Interval|Number
738402|NCT00457002|Secondary|Incidence of Adjudicated Non-Fatal PE With Onset During the Intended Treatment Period|Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Intended Treatment Period|Randomized participants except those with an inadequate assessment for symptomatic events that are part of the endpoint during the intended treatment were analyzed.||Event Rate (%)||95% Confidence Interval|Number
738403|NCT00457002|Secondary|Incidence of Adjudicated PE With Onset During the Intended Treatment Period|Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. PE: non-fatal or fatal. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Intended Treatment Period|Randomized participants except those with an inadequate assessment for symptomatic events that are part of the endpoint during the intended treatment were analyzed.||Event Rate (%)||95% Confidence Interval|Number
738404|NCT00457002|Secondary|Incidence of All VTE or Major Bleeding or All-Cause Death During the Intended Treatment Period|Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE: nonfatal PE, symptomatic DVT, or asymptomatic proximal DVT detected by ultrasound. VTE-related death: fatal PE or sudden death for which VTE cannot be excluded as a cause. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Intended Treatment Period|Those randomized with adjudicated and evaluable ultrasound at the end of the intended treatment period; for those with a suspected symptomatic event, the adjudication result was not inadequate; includes all those randomized who have an adjudicated event associated with the endpoint during Intended Treatment.||Event Rate (%)||95% Confidence Interval|Number
738405|NCT00457002|Secondary|Symptomatic Adjudicated VTE or VTE-Related Death With Onset During the Intended Treatment Period|Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE: nonfatal PE, symptomatic DVT, or asymptomatic proximal DVT detected by ultrasound. VTE-related death: fatal PE or sudden death for which VTE cannot be excluded as a cause. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Intended Treatment Period|Randomized participants except those with an inadequate assessment for symptomatic events that are part of the endpoint during the intended treatment were analyzed.||Event Rate (%)||95% Confidence Interval|Number
738406|NCT00457002|Secondary|Incidence of Adjudicated Symptomatic VTE or All-Cause Death With Onset During the Intended Treatment Period|Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE: nonfatal PE, symptomatic DVT, or asymptomatic proximal DVT detected by ultrasound. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Intended Treatment Period|Randomized participants except those with an inadequate assessment for symptomatic events that are part of the endpoint during the intended treatment were analyzed.||Event Rate (%)||95% Confidence Interval|Number
738407|NCT00457002|Secondary|Incidence of Adjudicated VTE-Related Death With Onset During the Intended Treatment Period in Randomized Participants|Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE-related death: fatal PE or sudden death for which VTE cannot be excluded as a cause. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Intended Treatment Period|All Randomized Participants.||Event Rate (%)||95% Confidence Interval|Number
738408|NCT00457002|Secondary|Incidence of Adjudicated Proximal DVT, Non-Fatal PE or VTE-Related Death, With Onset During the Intended Treatment Period|Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE-related death: fatal PE or sudden death for which VTE cannot be excluded as a cause. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Intended Treatment Period|Those randomized with adjudicated and evaluable ultrasound at the end of the intended treatment period; for those with a suspected symptomatic event, the adjudication result was not inadequate; includes all those randomized who have an adjudicated event associated with the endpoint during Intended Treatment.||Event Rate (%)||95% Confidence Interval|Number
738409|NCT00457002|Secondary|Incidence of Adjudicated Proximal DVT, Non-Fatal PE or All-Cause Death With Onset During the Intended Treatment Period|Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Intended Treatment Period|Those randomized with adjudicated and evaluable ultrasound at the end of the intended treatment period; for those with a suspected symptomatic event, the adjudication result was not inadequate; includes all those randomized who have an adjudicated event associated with the endpoint during Intended Treatment.||Event Rate (%)||95% Confidence Interval|Number
738410|NCT00457002|Secondary|Incidence of Adjudicated Total VTE or All-Cause Death With Onset During the Intended Treatment Period|Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE: nonfatal (N-F) PE, symptomatic DVT, or asymptomatic proximal DVT detected by ultrasound. VTE-related death: fatal PE or sudden death for which VTE cannot be excluded as a cause. All-Cause Death (A-C Death). Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Intended Treatment Period|Those randomized with adjudicated and evaluable ultrasound at the end of the intended treatment period; for those with a suspected symptomatic event, the adjudication result was not inadequate; includes all those randomized who have an adjudicated event associated with the endpoint during Intended Treatment.||Event Rate (%)||95% Confidence Interval|Number
738411|NCT00457002|Secondary|Incidence of Adjudicated Total VTE and VTE-Related Death During Parenteral Treatment in Secondary Efficacy Evaluable Participants|Parenteral study drug=active or placebo enoxaparin. Parenteral treatment: started on the first dose of parenteral study drug and ended the day after the last dose of parenteral study drug. Secondary Efficacy Evaluable includes those who had an adjudicated, evaluable ultrasound at end of parenteral treatment and for those with a suspected symptomatic event, the result of the adjudication for the symptomatic event was not inadequate; or those with an adjudicated event that was part of the composite endpoint.. Event rate (%): n/N*100 (n=number with observation; N=total secondary efficacy evaluable participants).|Day 1 to last dose of parenteral study drug plus 1 day|Secondary Efficacy Evaluable includes those who have an adjudicated, evaluable ultrasound at end of parenteral treatment and for those with a suspected symptomatic event, the result of the adjudication for the symptomatic event is not inadequate; or those with an adjudicated event that is part of the composite endpoint.||Event Rate (%)||95% Confidence Interval|Number
738412|NCT00457002|Secondary|Incidence of Adjudicated Total VTE and VTE-Related Death During Parenteral Treatment in Key Secondary Efficacy Evaluable Participants|Parenteral study drug=active or placebo enoxaparin. Parenteral treatment: started on the first dose of parenteral study drug and ended the day after the last dose of parenteral study drug. Key Secondary Efficacy population: all who received at least 1 dose of parenteral study drug and: (those without suspected VTE events during Parenteral Treatment) had an adjudicated evaluable ultrasound performed at the end of Parenteral Treatment; or (those with suspected VTE events during Parenteral Treatment) had those suspected VTE events adjudicated as non-events, and had an adjudicated evaluable ultrasound performed at the end of Parenteral Treatment; or had an adjudicated total VTE during Parenteral Treatment; or had an adjudicated VTE-related death during Parenteral Treatment. Event rate (%): n/N*100 (n=number with observation; N=total secondary efficacy evaluable participants).|Day 1 to last dose of parenteral study drug plus 1 day|Those randomized (without suspected VTE) who had an adjudicated and evaluable ultrasound at end of parenteral treatment; or (with suspected VTE) had VTE events adjudicated as non-events and had adjudicated and evaluable ultrasound at end of parenteral treatment, or had an adjudicated VTE-related death during the Parenteral Treatment Period.||Event rate (%)||95% Confidence Interval|Number
738413|NCT00457002|Primary|Incidence of Composite of Adjudicated Total Venous Thromboembolism (VTE) and VTE-related Death During the Intended Treatment Period - Primary Efficacy Population|VTE: nonfatal pulmonary embolism (PE), symptomatic deep vein thrombosis (DVT), or asymptomatic proximal DVT detected by ultrasound. VTE-related death: fatal PE or sudden death for which VTE could not be excluded as a cause. Intended Treatment Period=period that started on day of randomization: period ended (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; period ended (for not treated) 32 days after randomization. A bilateral compression ultrasound (CUS) was performed between Days 5 and 14 for detection of asymptomatic proximal DVT unless a symptomatic VTE was confirmed prior. CUS was also performed on Day 30 ± 2 except for those participants who had a confirmed symptomatic VTE or proximal asymptomatic DVT prior to that time. All efficacy events were adjudicated by the Independent Central Adjudication Committee (ICAC). Event rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Intended Treatment Period|Those randomized (without suspected VTE) who had an adjudicated and evaluable ultrasound at end of intended treatment; or (with suspected VTE) had VTE events adjudicated as non-events and had an adjudicated and evaluable ultrasound at end of intended treatment, or had an adjudicated total VTE-related death.||Event rate (%)||95% Confidence Interval|Number
738414|NCT00457015|Secondary|Proportion of Patients Maintaining a Significant Improvement in Overall Response Through 24 Hours|"Maintenance of significant improvement was defined as achieving and maintaining a significant improvement in overall response through 24 hours after dosing. Patient response categories were: significant improvement = a lot better or resolved; improvement = a little better; same = response unchanged; worsening = a little worse; significant worsening = a lot worse."|24 hours post-dosing|Diary information was not available for 1 patient in the placebo arm. This patient was considered not evaluable and excluded from the analysis.||participants|||Number
738415|NCT00457015|Secondary|Patients With a Successful Response at 4 Hours Post-dosing, Based on the Change From Baseline in the MSCS Score|A successful response was defined as improvement in existing laryngeal symptom complex,stabilization of an existing peripheral symptom complex, or a change from baseline in the MSCS score at 4 hours of at least -1.0.|baseline, 4 hours post-dosing|Diary information was not available for 1 patient in the placebo arm. This patient was considered not evaluable and excluded from the analysis.||participants|||Number
738416|NCT00457015|Secondary|Patients With Significant Improvement in Overall Response|"Patients were to be asked to perform an overall response assessment at intervals during the first 4 hours post-dose. Assessments were to be made relative to baseline (ie, immediately before initial dosing) using a 5-category scale. Categories were: significant improvement = a lot better or resolved; improvement = a little better; same = response unchanged; worsening = a little worse; significant worsening = a lot worse. Significant improvement is the first time that a patient responded to the overall response assessment as a lot better or resolved."|4 hours post-dose|The time to significant improvement is not provided in this display as the estimated median times were not reached by 240 minutes. Instead, the number of patients with significant improvement is provided per treatment arm.||participants|||Number
738417|NCT00457015|Secondary|Treatment Outcome Score at 4 Hours Post-Dose|Treatment Outcome Score (TOS) is a validated, comprehensive measure of symptom response to treatment. At 4 hours , patient assessment of response characterized by their change from baseline in symptom severity and collected by anatomic site of attack involvement, was recorded on a categorical scale (significant improvement [100; best value]to significant worsening [-100; worst value]). Clinically meaningful improvement was indicated by a TOS of 30 or higher.|4 hours post-dose|Patients were excluded from this analysis if they did not have data for the endpoint being analyzed. The reasons for patients being excluded from this analysis are for ecallantide: 1 patient treated for severe upper airway compromise and for placebo: 3 patient treated for severe upper airway compromise and 3 patients with missing 4-hour data.||units on a scale||Standard Deviation|Mean
738418|NCT00457015|Primary|Change From Baseline in Mean Symptom Complex Severity (MSCS) Score at 4 Hours Post-dose|The Mean Symptom Complex Severity (MSCS) score is a validated, comprehensive point-in-time measure of symptom severity. At baseline and 4 hours, patients rated the severity on a categorical scale (0 = normal, 1 = mild, 2 = moderate, 3 = severe) for symptoms at each affected anatomical location. Ratings were averaged to obtain the MSCS score. A decrease in MSCS score reflected an improvement in symptoms; clinically meaningful improvement was indicated by a reduction in the score of 0.30 or more.|baseline, 4 hours post-dose|Patients were excluded from the analysis if they did not have data for the endpoint being analyzed. Reasons for patients being excluded are for ecallantide: 1 patient treated for severe upper airway compromise; for placebo: 3 patient treated for severe upper airway compromise and 3 patients with missing 4-hour data. Best score=0.0; worst score=3.0.||units on a scale||Standard Deviation|Mean
738428|NCT00457249|Other Pre-specified|Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Either ADACEL® or DECAVAC® Vaccine.|Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions; Fever (Temperature), Headache, Myalgia, and Malaise.|Day 0 up to 14 days post-vaccination|Safety analysis was on all enrolled and vaccinated participants, intend-to-treat population.||Participants|||Number
738429|NCT00457249|Primary|Percentage of Participants With Booster Response to Tetanus and Diphtheria Post-vaccination With ADACEL® or DECAVAC® Vaccine.|Booster response was defined as a minimum rise in antibody concentration from pre- to post-vaccination. The minimum rise is at least 2 times, if pre-vaccination concentration is above the the cutoff value (Tetanus 5.47 IU/mL; Diphtheria 1.28 IU/mL) or at least 4 times it it is at or below the cutoff value.|Day 35 post-vaccination|Booster response was assessed in the per-protocol population.||Percentage of Participants|||Number
738430|NCT00457249|Primary|Percentage of Participants With Post-vaccination Tetanus and Diphtheria Concentrations ≥0.10 IU/mL (Seroprotection) ADACEL® or DECAVAC®.|Seroprotection was defined as a post-vaccination Concentrations of ≥0.10 IU/mL.|Day 35 post-vaccination|Seroprotection was assessed in the per-protocol population||Percentage of Participants|||Number
738431|NCT00457249|Primary|Geometric Mean Titers (GMTs) of Tetanus, Diphtheria, and Pertussis Antibodies Pre- and Post-Vaccination With ADACEL® or DECAVAC® Vaccine||Day 35 post-vaccination|GMTs and their 95% Confidence Intervals were assessed in the per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
738432|NCT00457301|Primary|EuroQol, EQ-5D.|Generic preference-based measure. EQ-5D consists of two sections: a 100-point visual analog scale (VAS) and a descriptive system that contains five attributes (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression) with three levels per attribute (“no problem”, “some problems” and “extreme problems”).Using the US scoring function EQ-5D index scores range from -0.11 (all-worst health state, worse than dead), to 0.00 (dead) to 1.00 (perfect health). The EQ-5D is easy to complete, valid and reliable.|At baseline and end of study (6 months).|To compare two independent means for a parallel trial design, 100 patients in each group were needed to detect a clinically important difference (CID) in EQ-5D index score (CID = 0.10, SD = 0.25) with a 5% probability of Type I error, two-sided-test and 80% power. ITT was conducted for 213 recruited patients. 47 records were imputed using LOCF.||mean EQ-5D index score||Standard Deviation|Mean
738433|NCT00457301|Primary|Management Composite|Changes in clinical management were recorded in the chart review form. The number of referrals to other healthcare providers, tests ordered (X-rays, blood test, bronchoscopies) and changes in medication (reduction or increase dosage, addition or discontinuation) were summed to produce the management composite.|At baseline and end of study (6 months)|Analysis was conducted using ITT, with 47 observations carried forward.||mean management composite||Standard Deviation|Mean
738434|NCT00457301|Secondary|The Hospital Anxiety and Depression Scale,HADS. Completed at Baseline and End of the Study.|HADS is a self-complete mental health measure. The scale consists of 14 items, seven of which assess anxiety and seven which assess depression. Each item is on a four point scale and the scores are added to give a total ranging from 0 to 21 for anxiety and 0 to 21 for depression. Higher scores indicate more severe anxiety or depression. A cut-point of 8 or 9 indicates mild burden for the two scales; 11 or 12 indicates severe . All the patients completed HADS at baseline and at the end of the study.|Baseline and end of study (6 months)|47 observation were imputed by LOCF and analyzed as ITT.||mean anxiety and depression||Standard Deviation|Mean
738435|NCT00457301|Primary|Communication Score|Each clinician-patient encounter was audio tape-recorded. The content of the tape-recordings was examined and results recorded on the communication form by three blinded raters. This form tallies the number of issues discussed. The number of issues is summed to produce a communication score. The issues discussed included health attributes included in the HUI2 and HUI3: ambulation, self-care, anxiety, depression, cognitive problems, pain (type and frequency), vision, hearing speech and dexterity problems.|Baseline and end of study (6 months)|Traditional analysis of covariance, ANCOVA was conducted to explore the difference between control and intervention groups at 6 months adjusting for baseline scores and transplant status. ITT was conducted and missing values were imputed using the LOCF.||Mean number of issues discussed||Standard Deviation|Mean
738436|NCT00457392|Secondary|EuroQol 5-Dimension Questionnaire (EQ-5D)- Health State Profile Utility Score|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in total score range -0.594 to 1.000; higher score indicates better health state."|Baseline and End of Treatment (EOT) or Withdrawal|Patients Reported Outcome (PRO) Analysis Set included participants from the FA population who had at least one EQ-5D assessment while on treatment. The 'n' signifies those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.||Units on a scale||Standard Deviation|Mean
738437|NCT00457392|Secondary|One-year Survival Probability|The 1 year survival probability was defined as the probability of survival at one year after the date of the start of the study treatment based on the Kaplan Meier estimate.|Baseline until death or until 28 days after last dose for the last participant|The FA set included all participants who were randomized, with study drug assignment designated according to actual randomization, regardless of whether participants received study drug according to the randomization schedule, or received a different drug from that to which they were randomized.||Percent chance of survival||95% Confidence Interval|Number
738438|NCT00457392|Secondary|Duration of Response (DR)|Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7.|Baseline to disease progression or death or discontinuation from study or 28 days after last dose|DR was calculated for the subgroup of participants from the FA set, with a confirmed objective tumor response.||Weeks||95% Confidence Interval|Median
739009|NCT00465088|Secondary|Percent Change in Non-HDL-C From Baseline to Week 12|(Week 12 non-HDL-C minus baseline non-HDL-C) x 100/baseline non-HDL-C|From baseline to Week 12|All treated subjects whose Week 12 value was obtained within the Week 12 visit window||percent change||95% Confidence Interval|Least Squares Mean
738439|NCT00457392|Secondary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.0. Confirmed response are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as disappearance of all lesions (target and/or non target). PR are those with at least 30% decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.|Baseline to disease progression or discontinuation from study or 28 days after last dose|The FA set included all participants who were randomized, with study drug assignment designated according to actual randomization, regardless of whether participants received study drug according to the randomization schedule, or received a different drug from that to which they were randomized.||Percentage of participants||95% Confidence Interval|Number
738440|NCT00457392|Secondary|Progression-Free Survival (PFS)|"Time in weeks from assignment to study medication to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Baseline to disease progression or death due to any cause or 28 days after last dose|The FA set included all participants who were randomized, with study drug assignment designated according to actual randomization, regardless of whether participants received study drug according to the randomization schedule, or received a different drug from that to which they were randomized.||Weeks||95% Confidence Interval|Median
738441|NCT00457392|Primary|Overall Survival (OS)|Overall survival is the duration from assignment to study medication to death. For participants who are alive, overall survival is censored at the last contact.|Baseline to death or 28 days after last dose for the last participant|The Full Analysis (FA) set included all participants who were randomized, with study drug assignment designated according to actual randomization, regardless of whether participants received study drug according to the randomization schedule, or received a different drug from that to which they were randomized.||Months||95% Confidence Interval|Median
738442|NCT00457418|Secondary|Number of Participants Who Experienced an Adverse Event (AE)|An adverse event (AE) was defined as any untoward medical occurrence or unfavorable and unintended sign in a subject administered a pharmaceutical product, biologic (at any dose), or medical device, whether or not considered related to the use of that product.|Entire study duration (up to 5 years)|||participants|||Number
738443|NCT00457418|Primary|Apparent Clearance(CL/F) of PEG-Intron at 12 Weeks|CL/F was defined apparent clearance - the volume of plasma in the vascular compartment cleared of drug per unit of time and per kilogram of body weight by the processes of metabolism and excretion.|Predose, and 24, 48, 72, 96, and 168 hours postdose at 12 weeks|There were 15 evaluable participants (20 participants completed the full 12 weeks of treatment without any significant dose modification but for 5 participants CL/F could not be reported because t1/2 could not be accurately determined).||L/hr/kg||Standard Deviation|Mean
738444|NCT00457418|Primary|Observed Time to Achieve Cmax (Tmax) of PEG-Intron at 12 Weeks|Tmax was defined as time of maximum plasma concentration.|Predose, and 24, 48, 72, 96, and 168 hours postdose at 12 weeks|Participants who completed the full 12 weeks of treatment without any significant dose modification (dose reduction or missing dose).||hours||Full Range|Median
738445|NCT00457418|Primary|Minimum Serum Concentration (Cmin) of PEG-Intron at 12 Weeks|Cmin was defined as observed minimum plasma concentration.|Predose, and 24, 48, 72, 96, and 168 hours postdose at 12 weeks|There were 19 evaluable participants (20 participants completed the full 12 weeks of treatment without any significant dose modification and there was no concentration data for 1 participant at Week 12).||pg/mL||Standard Deviation|Mean
738446|NCT00457418|Primary|Average Concentration Within the Dosing Interval (Cavg) of PEG-Intron at 12 Weeks|Cavg was defined as average plasma concentration.|Predose, and 24, 48, 72, 96, and 168 hours postdose at 12 weeks|Participants who completed the full 12 weeks of treatment without any significant dose modification (dose reduction or missing dose)||pg/mL||Standard Deviation|Mean
738447|NCT00457418|Primary|Maximum Serum Concentration (Cmax) of PEG-Intron at 12 Weeks|Cmax was defined as observed maximum plasma concentration.|Predose, and 24, 48, 72, 96, and 168 hours postdose at 12 weeks|Participants who completed the full 12 weeks of treatment without any significant dose modification (dose reduction or missing dose)||pg/mL||Standard Deviation|Mean
738448|NCT00457418|Primary|Area Under the Curve (AUC) of PEG-Intron at 12 Weeks|AUC was defined as the actual body exposure to drug after administration of a dose of the drug.|Predose, and 24, 48, 72, 96, and 168 hours postdose at 12 weeks|Participants who completed the full 12 weeks of treatment without any significant dose modification (dose reduction or missing dose)||pg*hr/mL||Standard Deviation|Mean
738449|NCT00457691|Secondary|Change From Baseline in EuroQol (EQ) Visual Analog Scale (VAS) (EQ-VAS)|EQ-5D: participant-rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.|Day 1 of Cycles 1-3 and Day 1 of every odd-numbered cycle thereafter until EOT/withdrawal|ITT population. The change from baseline scores for EQ-VAS were assessed for only those cycles where at least 10 participants on either treatment arm had available data (Cycles 2, 3, 5, 7, 9, and 11).||Scores on a scale||95% Confidence Interval|Mean
738450|NCT00457691|Secondary|Change From Baseline in European Quality of Life (EuroQol) EQ-5D Self-Report Questionnaire|"EQ-5D: participant-rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problem); 3 indicates worst health state (eg, confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain. Score is transformed and results in total score range -1.11 to 1.000; higher score indicates better health state."|Day 1 of Cycles 1-3 and Day 1 of every odd-numbered cycle thereafter until EOT/withdrawal|ITT population. The EQ-5D health state index results were assessed for only those cycles where at least 10 participants on either treatment arm had available data (Cycles 2, 3, 5, 7, 9, and 11).||Scores on a scale||95% Confidence Interval|Mean
738451|NCT00457691|Secondary|Change From Baseline in MDASI-GI Symptom Interference Score|Symptom Interference score is comprised of the sum 6 function items from MDASI core (general activity, walking, work, mood, relations with other people, and enjoyment of life). Participant asked to rate how much symptoms have interfered in past 24 hours; each item rated from 0 to 10, with 0=did not interfere and 10=interfered completely; lower scores indicated better outcome (range: 0 to 60).|Day 1 of Cycles 1-3 and Day 1 of every odd-numbered cycle thereafter until EOT/withdrawal|ITT population. The change from baseline MDASI-GI within each treatment arm was evaluated only for those cycles where at least 10 participants had available data (Cycles 2, 3, 5, 7, 9, 11).||scores on a scale||95% Confidence Interval|Mean
738452|NCT00457691|Secondary|Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Assessment Inventory of Gastrointestinal Symptoms (MDASI-GI) Symptom Intensity Score|Symptom Intensity score is comprised of the sum of 13 MDASI core items (ie, pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, remembering things, lack of appetite, drowsiness, dry mouth, sadness, vomiting, numbness or tingling). Participant asked to rate severity of each symptom at their worst in past 24 hours; each item rated from 0 to 10, with 0=symptom not present and 10=as bad as you can imagine; lower scores indicated better outcome (range: 0 to 130).|Day 1 of Cycles 1-3 and Day 1 of every odd-numbered cycle thereafter until end of treatment (EOT)/withdrawal|ITT population. The change from baseline MDASI-GI within each treatment arm was evaluated only for those cycles where at least 10 participants had available data (Cycles 2, 3, 5, 7, 9, and 11).||Scores on a scale||95% Confidence Interval|Mean
738453|NCT00457691|Secondary|Duration of Response (DR)|DR was defined as the time from the first objective documentation of CR or PR that was subsequently confirmed to the first documentation of disease progression or to death due to any cause, whichever occurred first.|Day 28 of Cycle 1 up to 30 months|ITT Population (participants with a confirmed objective tumor response).||Weeks||95% Confidence Interval|Median
738454|NCT00457691|Secondary|Number of Participants With Overall Confirmed Objective Response|Objective disease response: participants with a confirmed complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as the disappearance of all target lesions. PR was defined as a greater than or equal to 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Day 28 of Cycle 1 up to 30 months|||Participants|||Number
738455|NCT00457691|Secondary|Overall Survival (OS)|OS was defined as the time from randomization to the date of death due to any cause. OS data were censored on the day following the date of the last contact at which the patient was known to be alive.|Baseline up to 30 months|ITT Population.||Weeks||95% Confidence Interval|Median
738456|NCT00457691|Primary|Progression-free Survival (PFS)|PFS defined as time from date of randomization to date of first documentation of objective tumour progression or death due to any cause, whichever occurred first.|First dose of study treatment up to 30 months|Intent-to-treat (ITT) population included all participants who were randomized.||Weeks||95% Confidence Interval|Median
738457|NCT00457730|Secondary|Global Impression of Change|"global impression: How do you feel about the effects of the medication over the past 7 days? 7 point scale, 7 = delighted, 1= terrible"|Week 6 vs baseline|||units on a scale||Standard Deviation|Mean
738458|NCT00457730|Secondary|Percent Change in Average Pain Score.|Percent change in Weekly mean of 24 hour Average pain Score, Week 6 vs. baseline. Range is 0-10 with 0= no pain and 10= worst possible pain.|at week 6|||percent reduction on 0-10 analog scale||Standard Deviation|Mean
738459|NCT00457730|Primary|Percent Change in Worst Pain Score|Weekly mean of 24 hour Worst Pain Score, percent change from baseline. Range is 0-10 with 0= no pain and 10= worst possible pain.|at week 6|||percent reduction on 0-10 analog scale||Standard Deviation|Mean
738460|NCT00457743|Secondary|Overall Survival Time|"Overall Survival Time is defined as the time from the date of first dose of study treatment to the date of the death due to any cause. For subjects whose death had not been confirmed, Overall Survival Time was censored on the last date when the patient was known to be alive.
Survival was surveyed once a year from the registration day of the first subject, for all the subjects who received the study drug at least once."|From the first dose to death|Intent-to-Treat (ITT) population defined as all subjects enrolled in study that receive at least 1 dose of study medication.||Weeks||95% Confidence Interval|Median
738461|NCT00457743|Secondary|Time To Failure (TTF)|Time To Failure (TTF) is defined as the time from the date of first dose of study treatment to the date of the first documentation of Progressive Disease (PD), the date of treatment discontinuation except completion of treatment, or date of death due to cancer.|From the first dose to Progressive Disease, Treatment discontinuation except completion of treatment, or Death due to cancer.|Intent-to-Treat (ITT) population defined as all subjects enrolled in study that receive at least 1 dose of study medication.||Weeks||95% Confidence Interval|Median
738462|NCT00457743|Primary|Number of Subjects With Clinical Benefit Response (CBR) Based on the Extramural Review Committee Assessment in Recommended Dose Group|Clinical Benefit Response is defined as sum of subjects confirmed with complete response (CR), partial response (PR), or stable disease (SD)>= 22 weeks on study according to Response Evaluation Criteria in Solid Tumors (RECIST).|Day 28 of Cycles 1-4|Intent-to-Treat (ITT) population defined as all subjects enrolled in study that receive at least 1 dose of study medication.||participants|||Number
738463|NCT00457743|Primary|Accumulation Ratio (Rac) on Cycle 1 Day 28|"Accumulation Ratio (Rac) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) on Cycle 1 Day 28 in the subjects enrolled in Phase 1.
Rac was the ratio of Day 28 to Day 1."|Day 28 of Cycle 1|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacokinetic analysis.
3 subjects in 75-mg dose group discontinued before Cycle 1 Day 28, therefore no data presented."||ratio||Standard Deviation|Mean
738464|NCT00457743|Primary|SU-011248 Clearance on Cycle 1 Day 28|"SU-011248 Clearance in the subjects enrolled in Phase 1.
Clearance was calculated by dividing a SU-011248 dose(mg) by AUC0-24(ng•h/mL)."|Day 28 of Cycle 1|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacokinetic analysis.
3 subjects in 75-mg dose group discontinued before Cycle 1 Day 28, therefore no data presented."||L/h||Standard Deviation|Mean
738786|NCT00458211|Primary|Positive and Negative Syndrome Scale (PANSS) Measuring Symptoms of Schizophrenia|Minimum score 32 (best) maximum 210 (worst)|Baseline to 8 weeks|The four Rochester subjects were dropped as Rochester could not continue the study.19 Bronx and 17 Buffalo subjects were analyzed separately because they were so different(see baseline characteristics)||score on scale||Standard Deviation|Mean
738466|NCT00457743|Primary|Time to First Occurrence of Cmax (Tmax) on Cycle 1 Day 28|"Time to First Occurrence of Cmax (Tmax) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1.
The Tmax for total drug (SU-011248+SU-012662) was calculated as the median of the Tmax of total drug from each individual subject (it is not the simple sum of medians of Tmax of SU-011248 and SU-012662)."|Day 28 of Cycle 1|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacokinetic analysis.
3 subjects in 75-mg dose group discontinued before Cycle 1 Day 28, therefore no data presented."||hours||Full Range|Median
738467|NCT00457743|Primary|Time to First Occurrence of Cmax (Tmax) on Cycle 1 Day 1|"Time to First Occurrence of Cmax (Tmax) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1.
The Tmax for total drug (SU-011248+SU-012662) was calculated as the median of the Tmax of total drug from each individual subject (it is not the simple sum of median of Tmax of SU-011248 and SU-012662)."|Day 1 of Cycle 1|All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacokinetic analysis.||hours||Full Range|Median
738468|NCT00457743|Primary|Area Under the Plasma Concentration Curve (AUC0-24) on Cycle 1 Day 28|"Area Under the Plasma Concentration Curve (AUC0-24) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1.
The AUC0-24 for total drug (SU-011248+SU-012662) was calculated as the mean of the AUC0-24 of total drug from each individual subject (it is not the simple sum of means of AUC0-24 of SU-011248 and SU-012662)."|Day 28 of Cycle 1|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacokinetic analysis.
3 subjects in 75-mg dose group discontinued the dose on Cycle1, therefore no data showed."||ng•h/mL||Standard Deviation|Mean
738469|NCT00457743|Primary|Area Under the Plasma Concentration Curve (AUC0-24) on Cycle 1 Day 1|"Area Under the Plasma Concentration Curve (AUC0-24) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1.
The AUC0-24 for total drug (SU-011248+SU-012662) was calculated as the mean of the AUC0-24 of total drug from each individual subject (it is not the simple sum of means of AUC0-24 of SU-011248 and SU-012662)."|Day 1 of Cycle 1|All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacokinetic analysis.||ng•h/mL||Standard Deviation|Mean
738470|NCT00457743|Secondary|Time To Tumor Progression (TTP)|Time To tumor Progression (TTP) is defined as the time from the date of first dose of study treatment to the date of the first documentation of Progressive Disease (PD).|From the first dose to Progressive Disease|Intent-to-Treat (ITT) population defined as all subjects enrolled in study that receive at least 1 dose of study medication.||Weeks||95% Confidence Interval|Median
738471|NCT00457743|Secondary|Number of Subjects With Objective Response Based on the Extramural Review Committee Assessment in Recommended Dose Group|Number of subjects with Objective Response is defined as sum of the subjects confirmed with complete response (CR) and partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST).|Day 28 of Cycles 1-4|ITT population defined as all subjects enrolled in study that receive at least 1 dose of study medication.||participants|||Number
738472|NCT00457743|Primary|Maximum Plasma Concentration (Cmax) on Cycle 1 Day 28|"Maximum Plasma Concentration (Cmax) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1.
The Cmax for total drug (SU-011248+SU-012662) was calculated as the mean of the Cmax of total drug from each individual subject (it is not the simple sum of means of Cmax of SU-011248 and SU-012662)."|Day 28 of Cycle 1|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacokinetic analysis.
3 subjects in 75mg dose group discontinued before Cycle 1 Day 28, therefore no data presented."||ng/mL||Standard Deviation|Mean
738473|NCT00457743|Secondary|Number of Subjects With Disease Controlled Based on the Extramural Review Committee Assessment in Recommended Dose Group|Number of subjects with Disease Controlled is defined as sum of the subjects confirmed with complete response (CR), partial response (PR), or stable disease (SD)>= 10 weeks on study according to Response Evaluation Criteria in Solid Tumors (RECIST).|Day 28 of Cycles 1-4|Intent-to-Treat (ITT) population defined as all subjects enrolled in study that receive at least 1 dose of study medication.||participants|||Number
738474|NCT00457743|Secondary|Change From Baseline of European Quality of Life Questionnaire- 5 Dimensions(EQ-5D) Questionnaires|"The EQ-5D questionnaires evaluates 5 dimensions of health. The subjects rates the severity of impairment for each dimensions on a 3-point scale(1 to 3). The digits for five dimensions were combined in a five-digit number describing the respondent's health state. Health states were converted into a weighted health state index. High score is indicating high health.
Change from Baseline: weighted health state index at each observation minus weighted health state index at baseline"|Day 28 of Cycle 1; Day 1, 28 of Cycles 2-4|"Intent-to-Treat (ITT) population defined as all subjects enrolled in study that receive at least 1 dose of study medication.
n= Number of subjects with analyzable data."||index scores on a scale||Standard Deviation|Mean
738475|NCT00457743|Secondary|Changes From Baseline of Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Questionnaires|"Patient-reported outcome: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) questionnaires (version 4A).
The questionnaire consists of a 13-item subscale which covers specific fatigue questions. The subject rates the intensity of fatigue and its related symptoms on a five-point scale(0 to 4). High score is indicating low fatigue. The total score of the 13 items was evaluated.
Change from Baseline: Score at each observation minus score at baseline"|Day 7, 14, 28, 35 of Cycle 1; Day 1, 7, 14, 28, 35 of Cycles 2-4|"Intent-to-Treat (ITT) population defined as all subjects enrolled in study that receive at least 1 dose of study medication.
n= Number of subjects with analyzable data."||scores on a scale||Standard Deviation|Mean
738476|NCT00457743|Secondary|Trough Plasma Concentration (Ctrough) of SU-011248+SU-012662|Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration|Day 14, 28 of Cycle 1; Day 1, 14, 28 of Cycles 2-4|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacokinetic analysis.
n= Number of subjects with analyzable data."||ng/mL||Standard Deviation|Mean
738813|NCT00463437|Secondary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Titer Above the Cut-off Value|Meningococcal serogroup C serum bactericidal assay titer cut-off value assessed was ≥ 8.|Before (pre) and one month after (post) the booster administration|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.||subjects|||Number
738480|NCT00457743|Secondary|Plasma Concentrations of Soluble Vascular Endothelial Growth Factor Type 2 Receptors (sVEGFR2)|Plasma concentrations of potential pharmacodynamic markers; Soluble Vascular Endothelial Growth Factor Type 2 Receptors (sVEGFR2)|Day 1, 14, 28 of Cycles 1-4|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacodynamics analysis.
n= Number of subjects with analyzable data."||pg/mL||Standard Deviation|Mean
738481|NCT00457743|Secondary|Plasma Concentrations of Vascular Endothelial Growth Factor (VEGF)|Plasma concentrations of potential pharmacodynamic markers; Vascular Endothelial Growth Factor (VEGF)|Day 1, 14, 28 of Cycles 1-4|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacodynamics analysis.
n= Number of subjects with analyzable data."||pg/mL||Standard Deviation|Mean
738482|NCT00457743|Primary|Maximum Plasma Concentration (Cmax) on Cycle 1 Day 1|"Maximum Plasma Concentration (Cmax) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1.
The Cmax for total drug (SU-011248+SU-012662) was calculated as the mean of the Cmax of total drug from each individual subject (it is not the simple sum of means of Cmax of SU-011248 and SU-012662)."|Day 1 of Cycle 1|All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacokinetic analysis.||ng/mL||Standard Deviation|Mean
738483|NCT00457743|Primary|Number of Subjects With Dose Limiting Toxicities (DLT)|Dose Limiting Toxicities(DLT) in the subjects enrolled in Phase 1.|Cycle 1 (Baseline to Week 6)|DLT analysis population consists of subjects who developed DLT or received 85% of the planned dose. One subject in 75-mg dose group was excluded from DLT analysis population because the subject received less than 85% of the planned dose.||participants|||Number
738484|NCT00457795|Secondary|Change in Ocular Perfusion Pressure (OPP) Over a 24-Hour Period at Week 4|Change in ocular perfusion pressure (OPP) calculated over a 24-hour period separated into diurnal (7AM-11PM or awake period) and nocturnal (11PM-7AM or sleep period) at Week 4. Ocular perfusion pressure is blood pressure minus the intraocular pressure, which is a measurement of the fluid pressure inside the eye. Measurements of IOP and blood pressure were taken in the sitting and supine (laying down face up) body positions during the 16-hour (awake) period and in the supine position during the 8-hour nocturnal (sleep) period.|Week 4|Intent to Treat defined as all patients who started the study (randomized)||Millimeters of mercury (mmHg)||Standard Deviation|Mean
738485|NCT00457795|Secondary|Ocular Perfusion Pressure (OPP) for a 24-Hour Period at Week 4|Ocular perfusion pressure (OPP) calculated for a 24-hour period separated into diurnal (7AM-11PM or awake period) and nocturnal (11PM-7AM or sleep period) at week 4. Ocular perfusion pressure is blood pressure minus the intraocular pressure, which is a measurement of the fluid pressure inside the eye. Measurements of IOP and blood pressure were taken in the sitting and supine (laying down face up) body positions during the 16-hour diurnal (awake) period and in the supine position during the 8-hour nocturnal (sleep) period.|Week 4|Intent to Treat defined as all patients who started the study (randomized)||Millimeters of mercury (mmHg)||Standard Deviation|Mean
738486|NCT00457795|Secondary|Change From Baseline in Intraocular Pressure (IOP) for a 24-Hour Period at Week 4|Change from baseline in IOP for a 24-hour period separated into diurnal (7AM-11PM or awake period) and nocturnal (11PM-7AM or sleep period) at week 4. IOP is a measurement of the fluid pressure inside the eey. Measurements of IOP were taken in the sitting and supine (laying down face up) body positions during the 16-hour diurnal (awake) period and in the supine position during the 8-hour nocturnal (sleep) period. A negative number change from baseline indicates an improvement.|Baseline, Week 4|Intent to Treat defined as all patients who started the study (randomized)||Millimeters of mercury (mmHg)||Standard Deviation|Mean
738487|NCT00457795|Primary|Intraocular Pressure (IOP) for a 24-Hour Period at Week 4|IOP for a 24-hour period separated into diurnal(7AM-11PM or awake period) and nocturnal (11PM-7AM or sleep period) at week 4. IOP is a measurement of the fluid pressure inside the eye. Measurements of IOP were taken in the sitting and supine (laying down face up) body positions during the 16-hour diurnal (awake) period and in the supine position during the 8-hour nocturnal (sleep) period.|Week 4|Intent to Treat defined as all patients who started the study (randomized)||Millimeters of mercury (mmHg)||Standard Deviation|Mean
738488|NCT00457821|Primary|Number of Adverse Events (Combined Part 1 and Part 2)|Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug). Serious adverse events that were ongoing at the follow-up visit were followed until the event resolved, returned to baseline, or was determined to be a stable or chronic condition.|Baseline to Follow-up|All randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo).||events|||Number
738489|NCT00457821|Secondary|Change From Baseline in Maximum Sweat Chloride Concentration (Combined Part 1 and Part 2)|The sweat chloride (quantitative pilocarpine iontophoresis) test is a standard diagnostic tool for cystic fibrosis (CF), serving as an indicator of cystic fibrosis transmembrane conductance regulator (CFTR) activity.|14 days and 28 days|Due to the crossover design in Part 1, subjects were counted once for each period; therefore, the 4 unique subjects who received placebo were counted as 8 subjects in the analyses for Part 1.||millimoles per liter||95% Confidence Interval|Least Squares Mean
738490|NCT00457821|Secondary|Change From Baseline in the Cystic Fibrosis Questionnaire-Revised (CFQ-R) Score (Part 2 Only)(Respiratory Domain Score)|The CFQ-R is a health-related quality of life measure for subjects with cystic fibrosis. Each domain is scored from 0 (worst) to 100 (best). A difference of at least 4 points in the respiratory domain score of the CFQ-R is considered a minimal clinically important difference (MCID).|14 days and 28 days|Part 2 is a parallel study. Subjects were counted only once for each treatment group.||score on a scale||Standard Deviation|Mean
738491|NCT00457821|Secondary|Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second [FEV1] (Combined Part 1 and Part 2)|"Spirometry is a standardized assessment to evaluate lung function that is the most widely used endpoint in cystic fibrosis studies.
Relative change reflects the percent change from the baseline values [100% * (X-Y)/Y], where X and Y are post-baseline and baseline values, respectively."|14 days and 28 days|Due to the crossover design in Part 1, subjects were counted once for each period; therefore, the 4 unique subjects who received placebo were counted as 8 subjects in the analyses for Part 1.||percent predicted (%)||95% Confidence Interval|Least Squares Mean
738830|NCT00463580|Secondary|Correlation Coefficients Between Changes in HDRS Symptom Score and Changes in Diurnal Slope of Cortisol and ACTH, p.m. Cortisol Plasma Concentrations, Diurnal Plasma Concentrations of Inflammatory Cytokines and Their Receptors and Sleep Efficiency||Measured numerically and as the ratio of change score to baseline score||||||
738492|NCT00457821|Secondary|Change From Baseline in Nasal Potential Difference (Combined Part 1 and Part 2)|The transepithelial nasal potential difference (NPD) is a direct measure of transepithelial ion transport. NPD under conditions of zero chloride concentration perfusion solution in the presence of isoproterenol was of primary interest.|14 days and 28 days|Due to the crossover design in Part 1, subjects were counted once for each period; therefore, the 4 unique subjects who received placebo were counted as 8 subjects in the analyses for Part 1.||millivolts||95% Confidence Interval|Least Squares Mean
738493|NCT00457821|Primary|Number of Subjects With Adverse Events (Combined Part 1 and Part 2)|Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug). Serious adverse events that were ongoing at the follow-up visit were followed until the event resolved, returned to baseline, or was determined to be a stable or chronic condition.|Baseline to Follow-up|All randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo).||participants|||Number
738494|NCT00457951|Primary|Incidence of Treatment Failure|"The primary outcome of the study is Treatment Failure as defined by Failure to discharge from hospital based on GOLD (Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease) criteria or relapse after DC from hospital."|Time to hospital discharge and 21 days post-treatment, up to 31 days|Of the 138 subjects randomized, 132 were analyzed in the intent-to-treat population. Of the 6 excluded from the intent-to-treat population, 4 did not receive study drug and 2 lacked information for assessment.||percentage of failures||95% Confidence Interval|Number
738495|NCT00457977|Secondary|Serotype-specific Immunoglobulin G (IgG) Antibody Levels|Serotype-specific immunoglobulin G Geometric Mean IgG antibody levels (ug/ml)|Measured at Baseline, Months 1, 12, and 24|All participants with blood samples were analyzed.||ug/ml||95% Confidence Interval|Geometric Mean
738496|NCT00457977|Primary|Serotype Opsonization Titers|Opsonophagocytosis activity (OPK) serotype specific geometric means|Measured at Baseline, Months 1, 12, and 24|All participants with blood samples were analyzed.||titers||95% Confidence Interval|Geometric Mean
738497|NCT00444275|Secondary|Score Abacuses Based on the Reflux Disease Questionnaire (RDQ)|May be used to define the success of treatment. Not done|Week 4|The results of exploratory analyses are not available.|||||
738498|NCT00444275|Secondary|Score Abacuses Based on the Reflux Disease Questionnaire (RDQ) Questionnaire|"May be used to offer patients a strategy of treatment during the initial phase and in the long term.
Not done"|Day 0|The results of exploratory analyses are not available.|||||
738499|NCT00444275|Secondary|Score Abacuses Based on the Reflux Disease Questionnaire (RDQ) Questionnaire|May be used to evaluate the severity of symptoms during the initial visit. Not done|Day 0|The results of exploratory analyses are not available.|||||
738500|NCT00444275|Secondary|Number of Participants and Type of Serious Adverse Events and Adverse Events Leading to a Premature Discontinuation of the Study|Number of participants with serious adverse events and adverse events leading to study treatment discontinuation. AE and SAE as defined in ICH-GCP.|12 weeks - maintenance treatment phase|||Participants|||Number
738501|NCT00444275|Secondary|Impact of Anxiety and Depression During the Initial Visit Measured by the HADS ( Hospital Anxiety and Depression Scale) Questionnaire on Response to Initial Treatment and to Maintenance Treatment|Failure of treatment (as defined as in primary outcome measure) according to confirmed anxiety and depression during maintenance treatment evaluated by the patient via the score of HADS questionnaire. HADS scale ranges= 0 to 21 (the higher score, the worse : ≤7 : no anxiety-depression/ [8-10] : possible anxiety-depression/ >10 : anxiety-depression)|16 weeks|||Percent of participants with failure|||Number
738502|NCT00444275|Secondary|Differences Among Strategies of Maintenance Treatment for Satisfaction of the Patient, Using the GIS (Gord Impact Scale) Scale.(Change in Values of Score Derived From the GIS Questionnaire From V2 to V3 = Start to End of the Maintenance Phase)|Change in values of upper digestive symptoms (GORD Impact Scale) from week 4 to week 16. Scale of 1 to 4 : 1 = every day, 2 = often, 3 = sometime, 4 = never)|4 to 16 weeks|871 (-66 missing data, 801 (-56 missing data), 833 (-75 missing data)||Scores on scale||Standard Deviation|Mean
738503|NCT00444275|Secondary|Impact of Treatment With Low Dose Aspirin (Acetyl Salicylic Acid) Used Concomitantly During the Initial Phase and the Maintenance Phase|No possibility to describe as only 2 patients took ASA|4 weeks|Outcome measure not possible to describe as only 2 patients took Aspirin.|||||
738504|NCT00444275|Secondary|Difference in Symptom Severity Evaluation Performed by the Investigators, When Symptom Severity is Assessed With and Without Reflux Disease Questionnaire (RDQ).|"Total percentage of subjects for whom evaluation of symptom severity using the Reflux Disease Questionnaire (RDQ) is different, either positively or negatively, as compared to clinical judgment made by Investigator.
The RDQ Includes 12 Items: 6 Concern the Frequency of Symptoms Ranging From Never for the Lowest Frequency to Every Day for the Highest, 6 Others Assess the Severity of Symptoms From Not at All to Strong. The Total Score of the RDQ, Ranging From 0 to 40, is Obtained by Adding the Scores of Each Item."|4 weeks|||Percentage of participants|||Number
738505|NCT00444275|Primary|Efficacy of Three Strategies of Long-term Treatment|Percentage of failure of maintenance treatment between V2 (4 weeks) and V3 (16 weeks) evaluated by the patient, defined based on responses to 2 questions (if at least 1 negative response was given, the patient was considered to be in failure) : Did the treatment produce sufficient control of reflux symptoms? Do you wish to continue the treatment?|16 weeks|||Percentage of participants with failure|||Number
738506|NCT00449748|Primary|Number of Participants With Objective Response|Efficacy reported as objective response. Objective response defined as change in serum tryptase level or bone marrow mast cell percentage.|Monthly for first 3 months, then every 3 months|Analysis was per protocol.||Participants|||Number
738507|NCT00449787|Secondary|Patient Satisfaction|"At the 48 hour assessment, patients were asked, The next time you go to an emergency room with a headache, do you want to receive the same medication. This outcome tabulates the number of affirmative responses."|48 hours after ER discharge|||participants|||Number
738508|NCT00449787|Secondary|Headache-related Functional Disability|This is a recommend outcome in headache research. At the time of the assessment (48 hours after ER discharge), patients are asked to report their current level of functional impairment: severe (unable to do any activities); moderate (able to do a few activities); mild (able to do many but not all activities) or none (able to do all activities). For this analysis, patient's answers were dichotomized into some impairment or no impairment.|Baseline, two hours|Patients who reported any level of functional impairment (mild, moderate, or severe) are tabulated here.||participants|||Number
738509|NCT00449787|Primary|Numerical Rating Scale|"Within 48 hours of ED discharge, participants were allowed to take the investigational medication. At the moment they took the investigational medication, they were asked to record a number from 0 to 10, which represented their headache. 0 signified no pain and 10 signified the worse pain imaginable.
Two hours later, participants were asked again to record their pain on a scale from 0 to 10. The outcome is the change in pain between baseline and two hours and will be a number between 0 and 10. Greater numbes signify greater relief"|Baseline, two hours|After discharge from the emergency room, some patients had headache requiring use of medication and some did not. Only those patients who took the investigational medication were included in the analysis||units on a scale||Standard Deviation|Mean
738510|NCT00449865|Primary|The Global Outcome Combined Information on Change From Baseline in Schwab England Activities of Daily Living, 39-Item Parkinson’s Disease Questionnaire, Ambulatory Capacity, Symbol Digit Modalities, and Modified Rankin at 5 Years.|All outcomes were coded such that higher scores indicated worse outcomes. Patients were ranked on each outcome and their ranks were summed (summed-ranks). Higher summed ranks (range, 5-4775) indicate worse outcomes. The mean summed ranks were compared by treatment group by a global statistical test (GST).|Change from baseline to 5 YEARS|Intent-to-Treat sample: n = 955, participants randomized at least 5 years before July 2013 (time of planned interim analysis).||summed-ranks||95% Confidence Interval|Mean
738511|NCT00449930|Secondary|Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Vomiting||Baseline to Week 24|All randomized patients who received at least 1 dose of the double-blind study therapy.||Participants|||Number
738512|NCT00449930|Secondary|Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Abdominal Pain||Baseline to Week 24|All randomized patients who received at least 1 dose of the double-blind study therapy.||Participants|||Number
738513|NCT00449930|Secondary|Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Nausea||Baseline to Week 24|All randomized patients who received at least 1 dose of the double-blind study therapy.||Participants|||Number
738514|NCT00449930|Secondary|Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Diarrhea||Baseline to Week 24|All randomized patients who received at least 1 dose of the double-blind study therapy.||Participants|||Number
738515|NCT00449930|Primary|Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24|HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent.|Baseline and 24 weeks|The per protocol population required that a patient had measurements both at baseline and at Week 24, and did not have any major protocol violations (e.g. drug compliance <85%, addition of prohibited antihyperglycemic agent, incorrect double-blind study medication). No missing data were imputed.||Percent||95% Confidence Interval|Least Squares Mean
738516|NCT00449956|Secondary|Percent Change From Baseline in Outflow Pressure Reduction Rate at 8 Weeks|Percent Change from baseline to 8 weeks in Outflow Pressure Reduction Rate assessed 2 hours after ocular instillation (at Hour 2)|8 weeks|Last observed value during the 8-week treatment period was used in the FAS.||Percent Change||95% Confidence Interval|Least Squares Mean
738517|NCT00449956|Secondary|Percent Change From Baseline in Intraocular Pressure (IOP) at 8 Weeks|Percent Change from baseline to 8 weeks in Intraocular Pressure (IOP) assessed 2 hours after ocular instillation (at Hour 2)|8 Weeks|Last observed value during the 8-week treatment period was used in the FAS.||Percent Change||95% Confidence Interval|Least Squares Mean
738518|NCT00449956|Primary|Change in Intraocular Pressure (IOP) From Baseline at 8 Weeks|Change from baseline to 8 weeks in Intraocular Pressure (IOP) assessed 2 hours after ocular instillation (at Hour 2)|8 weeks|Last observed value during the 8-week treatment period was used in the Full Analysis Set (FAS).||mmHg||95% Confidence Interval|Least Squares Mean
738519|NCT00450112|Secondary|Acetaminophen Consumption|Weekly mean acetaminophen consumption between weeks 9 and 13.|Week 9 to Week 13|ITT population was used for analysis. 3 patients with 2Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.||milligrams||Standard Deviation|Mean
738520|NCT00450112|Secondary|Improvement From Baseline in Physician Global Evaluations|Observed physician evaluations on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning excellent feeling in knee joint; 100 mm meaning poor feeling in knee joint. Improved score from baseline to week 13 were calculated as baseline minus week 13.|Baseline and Week 13|ITT population was used for analysis. 3 patients with 2Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.||millimeters||Standard Deviation|Mean
738521|NCT00450112|Secondary|Improvement From Baseline in Subject Global Evaluations|Observed subject evaluations on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning excellent feeling in knee joint; 100 mm meaning poor feeling in knee joint. Improved score from baseline to week 13 were calculated as baseline minus week 13.|Baseline and Week 13|ITT population was used for analysis. 3 patients with 2Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.||millimeters||Standard Deviation|Mean
738522|NCT00450112|Secondary|Outcome Measures in Rheumatology Artthritis Clinical Trials (OMERACT) - and the Osteoarthritis Research Society International (OARSI) Response|Outcome Measures in Rheumatology Clinical Trials and Osteoarthritis Research Society International (OMERACT-OARSI) strict responses defined by improvements from baseline in WOMAC pain or physical function subscore ≥50% with absolute changes ≥20 mm (termed strict responders), or ≥20% with absolute changes ≥10mm in 2 of 3 measures of WOMAC pain or physical function subscore or subject global evaluations (termed responders).|Weeks 13|ITT population was used for analysis. 3 patients with 2Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.||Percentage of Participants|||Number
738523|NCT00450112|Secondary|Improvement From Baseline in WOMAC VAS (Total Score)|Observed all WOMAC mean scores on Visual Analog Scale (VAS) of 100 mm; a total of WOMAC pain, stiffness, and physical function subscores. Improved score from baseline to week 13 were calculated as baseline minus week 13.|Baseline and Week 13|ITT population was used for analysis. 3 patients with 2Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.||millimeters||Standard Deviation|Mean
738524|NCT00450112|Secondary|Improvement From Baseline in WOMAC VAS (Physical Function Subscore)|Observed WOMAC physical function subscore on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning no difficulty; 100 mm meaning extreme difficulty. Improved score from baseline to week 13 were calculated as baseline minus week 13.|Baseline and Week 13|ITT population was used for analysis. 3 patients with 2Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.||millimeters||Standard Deviation|Mean
738525|NCT00450112|Secondary|Improvement From Baseline in WOMAC VAS (Stiffness Subscore)|Observed WOMAC stiffness subscore on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning no stiffness; 100 mm meaning extreme stiffness. Improved score from baseline to week 13 were calculated as baseline minus week 13.|Baseline and Week 13|ITT population was used for analysis. 3 patients with 2Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.||millimeters||Standard Deviation|Mean
738526|NCT00450112|Secondary|Improvement From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) (Pain Subscore)|Observed WOMAC pain subscore on VAS of 100 mm.; 0 mm meaning no pain; 100 mm meaning extreme pain. Improved score from baseline to week 13 were calculated as baseline minus week 13.|Baseline and Week 13|ITT population was used for analysis. 3 patients with 2Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.||millimeters||Standard Deviation|Mean
738527|NCT00450112|Primary|Occurrence of Systemic and Local Adverse Events Following a Single or Repeat Intra-articular Injection of Gel-200||13 weeks|||participants|||Number
738528|NCT00450216|Secondary|The Number of Participants Developing Non-steroidal Anti-inflammatory (NSAID)Associated Serious Gastrointestinal Complications (Perforation of Ulcers, Gastric Outlet Obstruction Due to Ulcers, Gastrointestinal Bleeding)|The secondary efficacy endpoint was the number of participants developing a NSAID-associated serious gastrointestinal complication at any time throughout 24 weeks of treatment. A NSAID-associated serious gastrointestinal complication was defined as a perforation of ulcers, gastric outlet obstruction due to ulcers, and/or gastrointestinal bleeding.|24 weeks|||particpants|||Number
738529|NCT00450216|Secondary|Number of Participants Who Develop Endoscopically-diagnosed Duodenal Ulcers During the 24-week Treatment Period.|The secondary efficacy endpoint was the number of participants with duodenal ulcer at any time throughout 24 weeks of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter with unequivocal depth. A participant is considered to have completed the study if all scheduled assessments up through the Week 24 visit have been performed.|24 weeks|||participants|||Number
738530|NCT00450216|Secondary|Number of Participants Who Develop Endoscopically-diagnosed Upper Gastrointestinal (UGI) Ulcers During the 24-week Treatment Period.|The secondary efficacy endpoint was the number of participants with UGI (i.e., gastric and/or duodenal) ulcer at any time throughout 24 weeks of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter with unequivocal depth. A participant is considered to have completed the study if all scheduled assessments up through the Week 24 visit have been performed.|24 weeks|||participants|||Number
738531|NCT00450216|Primary|Number of Participants Who Develop Endoscopically-diagnosed Gastric Ulcers|The primary efficacy endpoint was the number of participants with gastric ulcer at any time throughout 24 weeks of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter with unequivocal depth. A participant is considered to have completed the study if all scheduled assessments up through the Week 24 visit have been performed.|24 weeks|All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination and at least the Week 8 endoscopic examination. Participants were assigned according to the treatment to which they were randomized; 2:1 randomization, HZT-501:ibuprofen.||participants|||Number
738532|NCT00450242|Secondary|Modified Gracely Pain Scale|The Modified Gracely Pain Scale consists of two components: 1) three numerical scales scored 0-100 for lowest, average, and highest pain level during during the preceding week, and 2) two word choice scales measuring affective and intensity levels. Each word in the word choice scales has an assigned number. Change scores on each subscale can thus be calculated over time (baseline v. week 8).|baseline, week 8|The study terminated due to lack of funding and difficulties with recruitment. More extensive data analysis to include secondary outcome measures was not performed due to inability to fund statistical programming and analysis efforts.||units on a scale|||Number
738533|NCT00450242|Secondary|SF-12 Quality of Life Scores|The SF-12 is a subset of 12 items from the Medical Outcomes Study 36-Item Short Form Survey (SF-36) and was collected at the bi-weekly office visits. Each score ranges from 0-100. The components measure physical and mental health, respectively. Higher scores are indicative of better function. ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, and age.|baseline, week 8|The study terminated due to lack of funding and difficulties with recruitment. More extensive data analysis to include secondary outcome measures was not performed due to inability to fund statistical programming and analysis efforts.||units on a scale|||Number
738534|NCT00450242|Primary|Change in Visual Analog Scale (VAS) Scores With Intercourse From Baseline to Week 8|"Visual Analog Scale (VAS) scores (range 0-100 mm; 0 = none, 100 = worst pain) were recorded for pain during intercourse during baseline and week 8 of the study, for lidocaine treated subjects and controls. The mean listed for each group is average week 8 score subtracted from the average baseline score."|baseline, week 8|three lidocaine subjects and one control subject failed to complete the study.||units on a scale||Standard Deviation|Mean
738535|NCT00450242|Primary|Number of Participants Who Report the Ability to Have Intercourse|Participants' response upon inquiry.|baseline, week 8|Three lidocaine subjects and one control subject failed to complete the study.||participants|||Number
738536|NCT00450255|Secondary|Impact of the VEGF Trap Therapy on Laboratory Correlates||Up to 5 years||||||
738537|NCT00450255|Secondary|Toxicities Assessed Using NCI CTCAE v3.0||Up to 5 years||||||
738538|NCT00450255|Secondary|Overall Survival|Will be estimated by the Kaplan-Meier method.|From the initial date of treatment to the recorded date of death, assessed up to 5 years|||Months||95% Confidence Interval|Median
738831|NCT00463580|Secondary|Between-group Differences (Mean ±SD) in the Change of Cortisol and ACTH Slope, p.m. Cortisol, Diurnal Plasma Cytokine and Cytokine Receptor Concentrations and Sleep Efficiency Between Baseline and Study Week 8.||Between baseline and study week 8.||||||
738539|NCT00450255|Primary|4 Month PFS Rate in Comparison With Historical Data|"Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
The targeted 4-months PFSR was based on three recently reported (at the time of study design) phase III randomized clinical trials with a median of 2.3 months PFS as a conservative external standard. If this regimen's improved median PFS from 2.3 to 4 months, corresponding to an improvement in the 4-month PFSR from 30% to 50% using a constant hazard model, we concluded that it would warrant further study. The study design yields a 85% power to detect a true 4-month PFS rate of at least 50%."|4 months|||percentage of patients||95% Confidence Interval|Number
738540|NCT00450255|Primary|Objective Response Rate (CR + PR)|"Using the RECIST v1.0 criteria for target lesions assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response = CR + PR.,"|Start of treatment to disease progression/recurrence, up to 5 years|||percentage of participants||95% Confidence Interval|Number
738541|NCT00450294|Primary|Left Intraocular Pressure|Intraocular pressure measurements were made with a tonometer. These measurements were recorded and kept blinded from the clinicians.|Measurements made at baseline, post induction preincision, 1 min post clamp, 5 min post clamp, 1 min pre unclamp, 1 min post unclamp, 5 min post unclamp, skin closure|||mm Hg||Standard Error|Least Squares Mean
738542|NCT00450294|Primary|Right Intraocular Pressure During Various Event Intervals in Open Abdominal Aortic Aneurysm Surgery.|Intraocular pressure measurements were made with a tonometer. These measurements were recorded and kept blinded from the clinicians.|Measurements made at baseline, post induction preincision, 1 min post clamp, 5 min post clamp, 1 min pre unclamp, 1 min post unclamp, 5 min post unclamp, skin closure|The analysis was per protocol.||mm Hg||Standard Error|Least Squares Mean
738543|NCT00450333|Secondary|Change From Baseline in Hematocrits at 16 and 24 Weeks|This study terminated early due to a decision by Shire Pharmaceuticals to permanently cease marketing Dynepo due to commercial reasons, it was not the result of any safety signal. Not enough subjects completed the study to do any efficacy analyses.|Baseline and Weeks 16 and 24|This study terminated early due to a decision by Shire Pharmaceuticals to permanently cease marketing Dynepo due to commercial reasons, it was not the result of any safety signal. Not enough subjects completed the study to do any efficacy analyses.|||||
738544|NCT00450333|Secondary|Number of Patients Who Achieve Hb Levels of > or Equal to 11 g/dL|This study terminated early due to a decision by Shire Pharmaceuticals to permanently cease marketing Dynepo due to commercial reasons, it was not the result of any safety signal. Not enough subjects completed the study to do any efficacy analyses.|week 16 and 24|This study terminated early due to a decision by Shire Pharmaceuticals to permanently cease marketing Dynepo due to commercial reasons, it was not the result of any safety signal. Not enough subjects completed the study to do any efficacy analyses.|||||
738545|NCT00450333|Primary|Change From Baseline in Hemoglobin (Hb) Concentration at 24 Weeks|This study terminated early due to a decision by Shire Pharmaceuticals to permanently cease marketing Dynepo due to commercial reasons, it was not the result of any safety signal. Not enough subjects completed the study to do any efficacy analyses.|Baseline and 24 weeks|This study terminated early due to a decision by Shire Pharmaceuticals to permanently cease marketing Dynepo due to commercial reasons, it was not the result of any safety signal. Not enough subjects completed the study to do any efficacy analyses.|||||
738546|NCT00450372|Secondary|Median Time to Progression|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Up to 16 months|Of the 38 subjects enrolled, only 10 were ASS-positive and 17 were ASS-negative. The remaining 11 subjects, who declined pre-treatment biopsies, were not assessed.||months||95% Confidence Interval|Median
738547|NCT00450372|Secondary|Median Overall Survival|Overall survival will be estimated using the product-limit method of Kaplan & Meier.|Up to 16 months|Of the 38 subjects enrolled, only 10 were ASS-positive and 17 were ASS-negative. The remaining 11 subjects, who declined pre-treatment biopsies, were not assessed.||months||95% Confidence Interval|Median
738548|NCT00450372|Primary|Response Rate (Partial and Complete Response) in Patients With or Without ASS Expression Present in Tumor.|Response rate is defined as a partial response, PR, and complete response, CR, lasting for at least 30 days per RECIST criteria, v. 1.0. Complete response will be defined as disappearance of all target lesions. Partial response will be defined as at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference the baseline sum of LD|Up to 16 months|Of the 38 subjects enrolled, only 10 were ASS-positive and 17 were ASS-negative. The remaining 11 subjects, who declined pre-treatment biopsies, were not assessed.||participants|||Number
738549|NCT00450385|Secondary|Number of Participants From Whom Fixed Tissue Samples Were Collected for Future Studies.|Number of participants from whom paraffin-embedded DLBCL tissue samples were collected for future studies.|Baseline|||Participants|||Count of Participants
738550|NCT00450385|Secondary|Overall Response Rate of Study Participants at the End of Protocol Therapy|Rate of participants achieving complete response (CR), complete response/unconfirmed (CRu) partial response (PR) according to Non-Hodgkin's Lymphoma response criteria.|Up to 8 cycles, about 24 weeks|||Participants|||Count of Participants
738551|NCT00450385|Secondary|Determination of the Ability of Models and/or Biomarkers Associated With Anti-Tumor Effects of Rituximab to Predict 24-month Time to Treatment Failure in DLBCL Patients Receiving R-CHOP Therapy|The investigators aim to determine the ability of the models and/or biomarkers associated with the anti-tumor effects of rituximab to predict 24-month time to treatment failure, defined as disease progression, death or initiation of new treatment.|24 Months|The determination could not be made because the study required a minimum of 90 participants for biomarker analyses and derivation of survival prediction model(s). Due to actual participant accrual (57) being far below the minimum required, no data were collected on the ability of models and/or biomarkers to predict time to treatment failure.|||||
738583|NCT00450580|Primary|Percentage of Participants With HIV-1 RNA <400 and >=400 Copies/mL Over 48 Weeks|A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at week 48. The percentage of participants with HIV-1 RNA <400 copies/mL at Week 48 was determined by the Time to Loss Of Virologic Response (TLOVR) algorithm.|Week 48|Intent-to-Treat-Exposed (ITT-E) Population: All randomised participants who received at least one dose of study medication||Percentage of participants|||Number
738552|NCT00450385|Primary|Comparison of the Ability of Constructed Survival Models to Predict Overall Survival in DLBCL Patients Receiving R-CHOP Therapy|The investigators will compare the ability of constructed survival models to predict survival in DLBCL patients receiving R-CHOP therapy|2 Years|The comparison could not be made because the study required a minimum of 90 participants for initial gene expression analyses from which survival prediction model(s) would be derived. Due to actual participant accrual (57) being far below the minimum number of participants required, no gene expression or survival prediction data were collected.|||||
738553|NCT00450385|Primary|Usefulness of Biomarkers Associated With Anti-Tumor Effects of Rituximab in Predicting Overall Survival in DLBCL Patients Receiving R-CHOP Therapy|The investigators aim to determine the usefulness of biomarkers associated with the antitumor effects of rituximab (e.g. immunoglobulin GFc receptor genotypes, CD20 protein expression and gene expression profiles) to predict overall survival of DLBCL patients treated with R-CHOP therapy and followed for at least 24 months or until death.|24 Months|The study required a minimum of 90 participants for associated biomarker analyses. Due to actual participant accrual (57) being far below the minimum number of participants required, no biomarker data were collected.|||||
738554|NCT00450385|Primary|Determination of a List of Genes and Construction of Survival Prediction Models That Will Predict Overall Survival at 30 Months in DLBCL Patients Receiving R-CHOP Therapy.|The investigators aim to determine a list of genes and construct survival prediction model(s) that will predict the overall survival at 30 months in DLBCL patients prospectively treated with R-CHOP chemotherapy. Overall survival time will be calculated from the date of the diagnosis until death or last follow-up examination.|30 months|The study required a minimum of 90 participants for gene expression analyses from which survival prediction model(s) could be derived. Due to actual participant accrual (57) being far below the minimum number of participants required, no data were collected on gene expression, and no survival prediction models were constructed.|||||
738555|NCT00450424|Secondary|Patient Satisfaction With the Preparation to Make a Decision|Participants completed a baseline survey upon enrollment to the trial. 2 weeks after baseline, they completed a follow-up survey (assessed at both baseline and FU).|at enrollment and 2 weeks after enrollment||||||
738556|NCT00450424|Secondary|Impact of Demographic Factors, Disease/Family History Characteristics, Family Support, and Cancer-related Distress on Satisfaction With and Completeness of the Informed Consent Process|Participants completed a baseline survey upon enrollment to the trial. 2 weeks after baseline, they completed a follow-up survey (assessed at both baseline and FU). Impact of demographic factors, disease/family history characteristics, family support, and cancer-related distress on satisfaction with and completeness of the informed consent process was measured|at enrollment and 2 weeks after enrollment||||||
738557|NCT00450424|Secondary|Differential Impact of CD-ROM on Satisfaction With MSI Test Decision, Difficulty Making Decision & Decisional Conflict; Attitude; General & Cancer-related Distress; Discussions With Family About MSI Test & Familial Colorectal Cancer Risk|Participants completed a baseline survey upon enrollment to the trial. 2 weeks after baseline, they completed a follow-up survey (assessed at both baseline and FU). Differential impact of CD-ROM on satisfaction with MSI test decision, difficulty making decision & decisional conflict; attitude; general & cancer-related distress; discussions with family about MSI test & familial colorectal cancer risk were measured.|at enrollment and 2 weeks after enrollment||||||
738558|NCT00450424|Primary|Impact of Standard Informed Consent vs CD-ROM Educational Intervention on Knowledge About Microsatellite Instability (MSI) Testing|"10-item true/false MSI knowledge survey developed by the oncologists on trial. (e.g., Microsatellite Instability is found in every person that has had cancer.; Microsatellite Instability may be caused by a permanent change in a gene that is inherited from a person’s mother or father.). Participants can score anywhere from 0 (no questions answered correctly) to 10 (all questions answered correctly)."|2 weeks after enrollment|||units on a scale||Standard Deviation|Mean
738559|NCT00450437|Primary|Percentage of Seroresponders, Ages 19 to 55 Years|"Immunogenicity of a single injection of Meningococcal ACWY (3 lots pooled) to that of a licensed meningococcal ACWY conjugate vaccine, defined as the percentage of subjects with seroreponse directed against N. meningitidis serogroups A, C, W, and Y (healthy subjects 19 to 55 years of Age).
Seroresponse to MenACWY: For a subject with hSBA titer <1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline."|28 days after vaccination|The analysis set was the per protocol (PP) population.||Percentage of participants||95% Confidence Interval|Number
738560|NCT00450437|Secondary|Number of Subjects With Local and Systemic Reactions, Ages 11 to 55 Years|Safety profile following a single injection of MenACWY (3 lots combined) was to that following a single injection of a licensed meningococcal ACWY conjugate vaccine administered to healthy adolescents or adults (11 to 55 years of age).|Days 1 to 7|The analysis was performed on the safety set.||Participants|||Number
738561|NCT00450437|Secondary|Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers, Ages 11 to 55 Years|Immunogenicity of a single injection of MenACWY (3 lots combined) to that of a single injection of a licensed meningococcal ACWY conjugate vaccine, as measured by hSBA GMTs directed against N meningitidis serogroups A, C, W, and Y (healthy subjects 11 to 55 years of age).|28 days after vaccination|The analysis set was the per protocol (PP) population.||Titers||95% Confidence Interval|Geometric Mean
738562|NCT00450437|Secondary|Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and hSBA Titer ≥ 1:4, Ages 11 to 55 Years|"Immunogenicity of a single injection of MenACWY (3 lots combined) to that of a licensed meningococcal ACWY conjugate vaccine, defined as the percentage of subjects with seroresponse directed against N meningitidis serogroups A, C, W, and Y (healthy subjects 11 to 55 years of age).
Seroresponse to MenACWY: For a subject with hSBA titer <1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline."|28 days after vaccination|The analyses set was performed on the per protocol (PP) population.||Percentage of participants||95% Confidence Interval|Number
738584|NCT00450619|Secondary|Palliation: Improvement in Baseline Pain|Subjective report of participant pain at baseline. This data reflects National Cancer Institute (NCI) patients only. This data was not systematically captured, so these results are based on subjective patient reports of improvement in pain on a scale of 1-10 post quadramet (samarium) as documented in the progress notes. 1-2 equals mild pain and 9-10 equals worst possible pain.|post quadramet (samarium)|||participants|||Number
738563|NCT00450437|Secondary|Lot to Lot Consistency for the Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and ≥ 1:4, Ages 11 to 18 Years|"The consistency of the immune response for three lots of Meningococcal ACWY, as measured by the percentage of subjects with seroresponse, hSBA titer ≥ 1:4 and ≥ 1:8, directed against N meningitidis serogroups A, C, W, and Y (healthy adolescents 11 to 18 years of age).
Seroresponse to MenACWY: For a subject with hSBA titer <1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline."|28 days after vaccination|The Analysis set was the per protocol (PP) population.||Percentage of Participants||95% Confidence Interval|Number
738564|NCT00450437|Primary|Number of Participants With at Least One Severe Systemic Reaction, Ages 11 to 55 Years|"Safety of Novartis Meningococcal ACWY and of a licensed meningococcal ACWY conjugate vaccine as measured by the number of participants presenting at least one severe systemic reaction during the first 7 days (Days 1-7) following a single vaccination.
Note: severe adverse events: unable to perform normal daily activity"|6 days after vaccination|The analysis was performed on the safety set.||Participants|||Number
738565|NCT00450437|Primary|Percentage of Seroresponders, Ages 11 to 18 Years|"Immunogenicity of a single injection of Meningococcal ACWY (3 lots pooled) to that of a licensed meningococcal ACWY conjugate vaccine, defined as the percentage of subjects with seroresponse directed against N meningitidis serogroups A, C, W, and Y (healthy adolescents 11 to 18 years of age).
Seroresponse to MenACWY: For a subject with hSBA titer <1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline."|28 days after vaccination|The analysis set was the per protocol (PP) population.||Percentage of participants||95% Confidence Interval|Number
738566|NCT00450437|Primary|Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years|The consistency of immune response for the three lots of Meningococcal ACWY (MenACWY), as measured by human serum bactericidal activity (hSBA) geometric mean titer (GMT) response using human complement (hSBA GMTs) directed against N. meningitidis serogroups A, C, W, and Y (healthy subjects 11 to 18 years of age)|28 days after vaccination|The analysis was performed on the Per Protocol (PP) Population||Titers||95% Confidence Interval|Geometric Mean
738567|NCT00450450|Other Pre-specified|Infused Nucleated and CD34+ Cell Doses|Compared using the Wilcoxon rank-sum test.|Up to 10 years|Data are not collected for this study.|||||
738568|NCT00450450|Other Pre-specified|Immune Reconstitution|Summarized graphically. Generalized estimating equation will be used to model the levels as a function of time and randomization assignment and to test the impact of G-CSF stimulation on immune reconstruction.|Up to 1 year|Data are not collected for this study.|||||
738569|NCT00450450|Secondary|Estimated Median Length of Initial Hospitalization|Estimated and compared between randomization arms using the Wilcoxon rank-sum test.|Up to 10 years|Data regarding length of Initial Hospitalization are not collected for this study according to Study Chair.|||||
738570|NCT00450450|Secondary|Estimated Median Time to Neutrophil Engraftment|Median Time from transplant to neutrophil engraftment|Up to 10 years|One patient was inevaluable and excluded from the analysis.||Days||95% Confidence Interval|Median
738571|NCT00450450|Secondary|Estimated Percentage of Chronic Graft-versus-host Disease (cGVHD)|cGVHD definition is based on BMT CTN MOP SEPT. 2005; outlined in Protocol Appendix III.|18 months post-transplant|Included only patients survived beyond 100 days.||percentage of patients|||Number
738572|NCT00450450|Secondary|Estimated 100-day Transplant Related Mortality (TRM) Percentage|Death in a patient after transplant due to protocol treatment is defined as an TRM.|100 days|One patient is inevaluable and is excluded from analysis.||percentage of patients|||Number
738573|NCT00450450|Secondary|Estimated Incidence of Grade III-IV Acute Graft-versus-host Disease (aGVHD)|Stage III-IV aGVHD is defined as: Stage 0-3 skin, with Stage 2-3 liver, or Stage 2-3 GI; OR Stage 4 skin, liver or GI involvement.|Up to 3 months|One patient is inevaluable and is excluded from analysis.||Percentage of patients|||Number
738574|NCT00450450|Secondary|Estimated Graft Failure Rate|Primary graft failure is defined as the failure to achieve an absolute neutrophil count of more than 5000 per cubic millimeter for at least three consecutive days by Day +42.|Up to 10 years|One patient is inevaluable for EFS on experimental arm and is excluded from analysis.||Percentage of patients|||Number
738575|NCT00450450|Primary|Estimated Two-year Event-free Survival (EFS)|EFS is defined as relapse or treatment-related mortality (TRM). relapse is defined by either morphological or cytogenetic evidence of ALL consistent with pre-transplant features.|at 2 years|Early terminated study. One patient is inevaluable for EFS on experimental arm and is excluded from analysis.||Percentage of patients||95% Confidence Interval|Number
738576|NCT00450580|Secondary|Study Endpoints for a Subset of Subjects Receiving Study Drug Beyond 48 Weeks|Adaptive two-stage design study up to 48 weeks. N=200, expanding to 728 if continuation criteria were achieved based on a 24-week interim analysis. The initial 200 participants would continue until the last subject of the expanded cohort reached 48 weeks and would constitute the subset. As continuation criteria were not achieved, the study did not proceed to the second stage, and full analysis was performed on the initial 200 participants only.|Up to 60 weeks||||||
738577|NCT00450580|Secondary|Steady-state Levels of Amprenavir (APV) and Ritonavir (RTV) Ctau at Weeks 4, 12, and 24|Blood samples were drawn at Weeks 4, 12, and 24 to determine plasma concentrations (Ctau) of APV and RTV|Weeks 4, 12, and 24|PK parameter (Ctau) Population – Participants in the ITT-E population who underwent PK sampling and had evaluable APV Ctau or RTV Ctau data||micrograms/mL||95% Confidence Interval|Geometric Mean
738578|NCT00450580|Secondary|Number of Protocol-defined Virological Failures With Genotypic and Phenotypic Resistance Changes|A blood sample was drawn at the time of confirmation of virological failure, and mutations present in the virus were identified and compared to those found in the blood sample at baseline. New mutations were tabulated by drug class. RT, reverse transcriptase. Virological failure could occur anytime from Week 4 to Week 48.|Time to virologic failure; Week 4 up to Week 48|Participants in the ITT-E Population who met the definition of virological failure||Participants|||Number
738579|NCT00450580|Secondary|Change From Baseline in Non-HDL Cholesterol at Week 48|Blood samples were drawn to determine the non-HDL cholesterol levels at Week 48. The mean absolute change in non-HDL cholesterol was defined as the Week 48 levels minus levels at baseline.|Week 48|Safety Population: all participants who received at least one dose of study medication||mmol/L (millimoles/Liter)||Standard Deviation|Mean
738585|NCT00450619|Secondary|Palliation: Pain at Baseline|Subjective report of participant pain at baseline.This data reflects National Cancer Institute (NCI) patients only. This data was not systematically captured, so these results are based on subjective patient reports of improvement in pain on a scale of 1-10 post quadramet (samarium) as documented in the progress notes. 1-2 equals mild pain and 9-10 equals worst possible pain.|Baseline|||participants|||Number
738586|NCT00450619|Secondary|Objective Response (Complete Response + Partial Response)|Objective response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is the disappearance of all target lesions. Partial response (PR) is at least a 30% increase in the sum of the LD of target lesions, taking as reference the baseline sum LD.|4 weeks|Not all participants was measureable by RECIST.||participants|||Number
738587|NCT00450619|Secondary|Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment|PSA T-cell responses were measured by fluorescence activated cell sorting (FACS)-based assay for T-cells expressing type I cytokines interferon (IFN-ϓ), interleukin 2 (IL2), tumor necrosis factor alpha (TNF-a) and/or lysosome-associated membrane protein (CD107a).|Approximately 60 days|(a)Cytokine or CD107a in CD4 or CD8. *Pts displayed pre-existing PSA-specific T-cell responses. Numbers 786, 374, 345, 402, 821, 815, 5269, 453, 633, 1242 & 0 for PT 2 CD4/CD8 IL2 & 0 for PT 16 TNF are those positive post- vs. pre-vaccination. Absolute # CD4 or CD8 producing cytokine/CD107a+/1x10(6) cells plated at start of in vitro stimulation.||Absolute # CD4 or CD8 producing cytokine|||Number
738588|NCT00450619|Secondary|Arm A: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment|PSA T-cell responses were measured by fluorescence activated cell sorting (FACS)-based assay for T-cells expressing type I cytokines interferon (IFN-ϓ), interleukin 2 (IL2), tumor necrosis factor alpha (TNF-a) and/or lysosome-associated membrane protein (CD107a).|Approximately 60 days|(a)Cytokine or CD107a in CD4 or CD8. *Pts displayed pre-existing PSA-specific T-cell responses. Numbers 274, 630, and 1427 are those positive post- vs. pre-vaccination. Absolute # CD4 or CD8 producing cytokine/CD107a+/1x10(6) cells plated at start of in vitro stimulation.||Absolute # CD4 or CD8 producing cytokine|||Number
738589|NCT00450619|Secondary|Overall Survival|Time from treatment start date until date of death or date last known alive.|From date of randomization until death or last follow up, whichever comes first, assessed up to 14 months.|||Months||95% Confidence Interval|Median
738590|NCT00450619|Secondary|Number of Participants With Prostate-Specific Antigen (PSA) ≥50%|PSA is defined by the PSA Working Group criteria. A minimum PSA decline of at least 50% must be confirmed by a second PSA value 4 or more weeks later.|4 months|||participants|||Number
738591|NCT00450619|Secondary|Number of Participants With Prostate-Specific Antigen (PSA) ≥ 30%|PSA is defined by the PSA Working Group criteria. A minimum PSA decline of at least 50% must be confirmed by a second PSA value 4 or more weeks later.|4 months|||participants|||Number
738592|NCT00450619|Secondary|Toxicity|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|5 years, 5 months|||Participants|||Number
738593|NCT00450619|Primary|Progression Free Survival (PFS)|PFS is defined as the time to progress or die after the start of the therapy.|4 months|||months||95% Confidence Interval|Median
738594|NCT00450619|Primary|Number of Patients With Stable Disease at 4 Months.|Response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Stable disease is neither sufficient shrinkage to qualify for partial response (PR) nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum longest diameter (LD) since the treatment started. Partial response (PR) is at least a 30% increase in the sum of the LD of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions on computed tomography (CT) or two or more lesions on bone scan.|4.7 months|||participants|||Number
738595|NCT00450658|Secondary|The Incidence Rate of NSAID-associated Serious Gastrointestinal Complications.|The secondary efficacy endpoint was the number of subjects developing a NSAID-associated serious GI complication at any time throughout 6 months of treatment. A NSAID-associated serious GI complication was defined as a perforation of ulcers, gastric outlet obstruction due to ulcers, and/or GI bleeding.|24 weeks|All randomized subjects who received at least one dose of study drug and who underwent a baseline endoscopic exam. Subjects were assigned according to the treatment to which they received.||participants|||Number
738596|NCT00450658|Secondary|Number of Subjects Who Develop Endoscopically-diagnosed Duodenal Ulcers During the 24-week Treatment Period.|The secondary efficacy endpoint was the number of subjects with duodenal ulcer at any time throughout the 24 weeks of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter with unequivocal depth. A subject is considered to have completed the study if all scheduled assessments up through the Week 24 visit have been performed.|24 weeks|||participants|||Number
738597|NCT00450658|Secondary|Number of Subjects Who Develop Endoscopically-diagnosed Gastric Ulcers During the 24-week Treatment Period.|The secondary efficacy endpoint was the number of subjects with gastric ulcer at any time throughout 24 weeks of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter with unequivocal depth. A subject is considered to have completed the study if all scheduled assessments up through the Week 24 visit have been performed.|24 weeks|The secondary efficacy endpoint was the number of subjects with gastric ulcer at any time throughout 24 weeks of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter with unequivocal depth. A subject is considered to have completed the study if all scheduled assessments up through the Week 24 visit were performed.||participants|||Number
738598|NCT00450658|Primary|Number of Subjects Who Develop Endoscopically-diagnosed Upper Gastrointestinal Ulcers Confirmed by Endoscopy.|The primary efficacy endpoint was the number of subjects with upper gastrointestinal (i.e., gastric and/or duodenal) ulcer at any time throughout 24 weeks of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter with unequivocal depth. A subject is considered to have completed the study if all scheduled assessments up through the Week 24 visit have been performed.|24 weeks|All randomized subjects who received at least one dose of study drug and who underwent a baseline endoscopic examination and at least the Week 8 endoscopic examination.||participants|||Number
738599|NCT00450723|Primary|Number of Patients With Identifiable Internal Mammary Sentinel Lymph Nodes||5 years|Of the 39 patients enrolled, 34 had identifiable internal mammary sentinel lymph nodes.||participants|||Number
738600|NCT00450723|Primary|Rate of Metastatic Disease in Internal Mammary Sentinel Lymph Nodes||5 years|||participants|||Number
738612|NCT00450749|Primary|Concentration of Lycopene in Prostatic Surgical Tissue|Total tissue lycopene concentrations in radical prostatectomy specimens in participants receiving 6 weeks (± 1 week) of preoperative supplementation with 60 mg/day lycopene, 30 mg/day lycopene, or placebo. Concentration of lycopene in prostatic surgical tissue calculated using the high-performance liquid chromatography (HPLC) method.|At 4-7 weeks|Tissue samples collected from five participants for measurement of lycopene levels, representing only 50% (5 of 10) of the participants’ enrolled on-trial.||ug/dL|||Number
738613|NCT00450801|Secondary|Number of Patients Experiencing Adverse Events.|Number of patients experiencing adverse events during the course of protocol therapy.|Up to 5 years|||participants|||Number
738614|NCT00450801|Secondary|Response Rate|Percentage of participants achieving complete response (CR) to protocol therapy according to International Working Group Response Criteria for Non-Hodgkin's Lymphoma (NHL) using the CT imaging method. Patients were classified by best tumor response; CR was defined as normalization of the lactate dehydrogenase (LDH), complete disappearance of disease-related symptoms and lymph nodes, and clearance of lymphoma from involved organs; complete response unconfirmed (CRu) as a residual lymph node greater than 1.5 cm in greatest transverse diameter that had regressed by more than 75% or an indeterminate bone marrow examination; partial response (PR) as greater than 50% reduction in the involved lymph nodes, or disappearance of the involved lymph nodes but persistent bone marrow involvement; relapse/progression as new or increased lymph nodes, organomegaly, or reappearance of bone marrow involvement.|Up to 5 years|Participants who completed at least two cycles of therapy.||percentage of participants||95% Confidence Interval|Number
738615|NCT00450801|Secondary|Overall Survival Rate|Percentage of participants who are alive up to five years after receipt of protocol therapy.|Up to 5 years|||percentage of participants||95% Confidence Interval|Number
738616|NCT00450801|Primary|Progression-free Survival Rate|Percentage of participants achieving progression-free survival at 1, 3 and 5 years after the start of protocol therapy, based upon the International Working Group Response Criteria for Non-Hodgkin's Lymphoma (NHL). Progression is defined as a ≥ 50% increase from nadir in the product of the two largest perpendicular diameters (PPD-size) of any previously identified abnormal node, or appearance of any new lesion.|Up to 5 years|||percentage of participants||95% Confidence Interval|Number
738617|NCT00450866|Secondary|Overall Survival|Median time (months) that patients survived during the duration of the study.|48 months from start of study|Intention to treat||months||95% Confidence Interval|Median
738618|NCT00450866|Secondary|Systemic Disease Response Rate for Measurable Disease Will be Assessed by the Modified McDonald Criteria|Complete Response (CR): the circumstance when the tumor is no longer seen by neuroimaging Partial Response (PR): Decrease of >50% in the product of two diameters Stable Disease (SD): the circumstance when the scan shows no change. Progression (P): a > 25% increase in tumor area (two diameters)|3 months after treatment|Intention to treat||participants|||Number
738619|NCT00450866|Secondary|CNS Response Rate, for Measurable Disease Will be Assessed by the Modified McDonald Criteria|Complete Response (CR): the circumstance when the tumor is no longer seen by neuroimaging Partial Response (PR): Decrease of >50% in the product of two diameters Stable Disease (SD): the circumstance when the scan shows no change. Progression (P): a > 25% increase in tumor area (two diameters)|3 months after treatment|Intention to treat||participants|||Number
738620|NCT00450866|Secondary|Toxicity as Measured by NCI CTCAE v3.0|Percent of patients that experience the most common grade 3 and above toxicities possibly related to study drug – to be measured using the NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3.0.|3 months after treatment|Intention to treat||percentage of participants|||Number
738621|NCT00450866|Primary|Central Nervous System (CNS) Progression-free Survival(PFS)|"The number of patients that are documented to have progression free survival at 3 months after treatment. Progression free is define as <25% increase in tumor area.
PFS will be measured from the date of entry into the trial to the date of documented progression of brain metastases or death."|3 months after treatment|Intention to treat||participants|||Number
738622|NCT00450983|Secondary|Expression of NKG2 Ligands of Leukemic Blasts||Up to 5 years|Analysis for this endpoint not feasible due to funding constraint.|||||
738623|NCT00450983|Secondary|Reconstitution of NK Function According to Time After HSCT||Up to 5 years|Analysis for this endpoint not feasible due to funding constraint.|||||
738624|NCT00450983|Secondary|Genotype and Phenotype of Donor Killer Cell Immunoglobulin-like Receptor Expression According to Time After Hematopoietic Stem Cell Transplantation (HSCT)||Up to 5 years|Analysis for this endpoint not feasible due to funding constraint.|||||
738625|NCT00450983|Secondary|Cytomegalovirus-specific T Cells in Product and Donor Graft||Up to 5 years|Analysis for this endpoint not feasible due to funding constraint.|||||
738626|NCT00450983|Secondary|Concentration of NK, NK-T, T-cells, and Dendritic Cell Subsets in the CD34+ NK/NK-T-enriched Graft||Up to 5 years|Analysis for this endpoint not feasible due to funding constraint.|||||
738627|NCT00450983|Secondary|Risk for Life-threatening Infections|Count of participants with life-threatening infections|Up to day 100|||Participants|||Count of Participants
738628|NCT00450983|Secondary|Risk for Graft Failure|Count of participant that had graft failure.|Engraftment documented day +20|||Participants|||Count of Participants
738629|NCT00450983|Secondary|Risk for Mortality From Infection Before Day 180|Count of participant deaths from infection up to day 180.|Up to day 180|||Participants|||Count of Participants
738630|NCT00450983|Primary|Risk of Developing Grades III-IV Acute Graft-vs-host Disease (GVHD)|Count of participants with acute GVHD grades III-IV.|Up to day 100|||Participants|||Count of Participants
738631|NCT00451048|Secondary|Frequency and Severity of Observed Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0)||Up to 6 years||||||
738632|NCT00451048|Secondary|Time to Progression||At 6 months and 1 year||||||
738633|NCT00451048|Secondary|Progression-free Survival||At 6 months and 1 year||||||
738634|NCT00451048|Secondary|Overall Survival||At 6 months and 1 year||||||
738635|NCT00451048|Secondary|Duration of Response||Up to 6 years||||||
738636|NCT00451048|Primary|Overall Response Rate (Complete Response, Partial Response, or Hematologic Improvement) Defined by the International Working Group Criteria||Up to 6 years|||percentage of participants|||Number
738637|NCT00451191|Primary|Improvement in the AUA Symptom Score Index by 30% From Baseline Within the First 12 Weeks After Injection.|The primary outcome was treatment success at 3 months post-treatment, defined as (1) improvement in the AUASI by at least 30% and/or (2) Qmax improvement of more than 30%, each determined from baseline to 3 months after injection. In addition, two safety criteria also had to be met; a dose failed if (1) any reported event was determined to be related to the onabotulinum toxin A injection and was considered life threatening, disabling, or fatal or (2) >=40% of the participants reported a moderate or severe side effect related to the botulinum toxin injection.|12 weeks|By the last 12-month follow-up visit, 15 men (22%) in the 100 U dose arm and 11 (17%) in the 300 U dose arm had withdrawn due to dissatisfaction with treatment results or continued to attend study follow-up but received additional alternate treatment prior to 12 months.||participants|||Number
738638|NCT00451204|Other Pre-specified|Relapse Event, Annualized Relapse Rate|Met all criteria for relapse except not confirmed to have increase in EDSS by an independent examiner.|12 months|||relapses per year||95% Confidence Interval|Mean
738639|NCT00451204|Other Pre-specified|Confirmed Relapse, Annualized Relapse Rate|A confirmed relapse was defined as new neurological symptoms or worsening of pre-existing symptoms, lasting at least 48 hours in a subject who had been neurologically stable or improving in the previous 30 days, accompanied by objective change in the neurological examination (worsening of 0.5 points on the EDSS or worsening by 1.0 or more points on the pyramidal, cerebellar, brainstem or visual functional system scores), not due to fatigue alone and not associated with fever or infection.|12 months|||relapses per year||95% Confidence Interval|Mean
738640|NCT00451204|Secondary|Relapse Event, Probability of First Relapse Event||24 months|Included all as intention to treat||probability of relapse event at 24 mo||95% Confidence Interval|Mean
738641|NCT00451204|Secondary|Confirmed Relapse, Probability of First Relapse||24 months|All included as intention to treat||probability of relapse at 24 months||95% Confidence Interval|Mean
738642|NCT00451204|Secondary|Relapse Event, Annualized Relapse Rate|Met all criteria for relapse except not confirmed to have increase in EDSS by an independent examiner.|24 months|Included all as intention to treat.||relapses per year||95% Confidence Interval|Mean
738643|NCT00451204|Primary|Confirmed Relapse, Annualized Relapse Rate|A confirmed relapse was defined as new neurological symptoms or worsening of pre-existing symptoms, lasting at least 48 hours in a subject who had been neurologically stable or improving in the previous 30 days, accompanied by objective change in the neurological examination (worsening of 0.5 points on the EDSS or worsening by 1.0 or more points on the pyramidal, cerebellar, brainstem or visual functional system scores), not due to fatigue alone and not associated with fever or infection.|24 months|Included all as intention to treat||relapses per year||95% Confidence Interval|Mean
738644|NCT00451282|Secondary|Health Service Utilization Over the 6 Months Post-injury|Medical records were used as the primary source of service utilization data; parent report supplemented this information if records were unavailable.|6 months||||||
738645|NCT00451282|Secondary|Adherence With Medical Discharge Instructions|The Health Care Questionnaire for Parents, created for this study, will assess health services utilized post-injury, adherence with specific discharge instructions (e.g., attendance at recommended follow-up appointments), as well as the number of days missed from work (parent) or school (child) related to the injury. Outcome variables to assess adherence will be dichotomized (e.g., attended scheduled appt? yes / no). The Health Care Questionnaire for Primary Care Physicians (PCPs) will assess primary care providers’ contacts with study participants, including whether psychosocial concerns were identified since the injury.|6 months||||||
738646|NCT00451282|Secondary|Health-related Quality of Life 6 Weeks and 6 Months Post-injury|The Pediatric Quality of Life Inventory is a well-validated measure of child health-related quality of life. Children completed the measure at baseline to report preinjury functioning and at 6-weeks and 6-months postinjury regarding current functioning. Current analyses utilize the 8-item Physical health/Physical functioning subscale. Scores range from 0-100; higher scores indicate better functioning outcomes.|6 months||||||
738647|NCT00451282|Secondary|Depression Symptoms in Children 6 Mos Post-injury|The Center for Epidemiologic Studies Depression Scale (CES-D) is a 20-item self-report measure of depression symptoms that yields a total severity score (range 0-60) . Clinical cut-off scores (≥16 for adults and ≥24 for youth) have been empirically established. Higher values represent more significant severity of symptoms of depression. The CES-D has been validated in adults and children 10 and over as an effective screen for depression. The CES-D was administered at baseline (prerandomization), 6 weeks and 6 months postinjury.|6 months|85 children were randomly assigned to receive usual care (n=39) or the intervention (n=46, 5 did not go on to receive intervention). Of these subjects, 31 usual care subjects and 37 intervention subjects completed 6 week follow-up.||Units on a scale||Standard Deviation|Mean
738648|NCT00451282|Secondary|Depression Symptoms in Children 6 Wks Post-injury|The Center for Epidemiologic Studies Depression Scale (CES-D) is a 20-item self-report measure of depression symptoms that yields a total severity score (range 0-60) . Clinical cut-off scores (≥16 for adults and ≥24 for youth) have been empirically established. Higher values represent more significant severity of symptoms of depression. The CES-D has been validated in adults and children 10 and over as an effective screen for depression. The CES-D was administered at baseline (prerandomization), 6 weeks and 6 months postinjury.|6 weeks|85 children were randomly assigned to receive usual care (n=39) or the intervention (n=46, 5 did not go on to receive intervention). Of these subjects, 28 usual care subjects and 36 intervention subjects completed 6 week follow-up.||Units on a scale||Standard Deviation|Mean
738649|NCT00451282|Primary|PTSD Symptoms in Children 6 Months Post-injury|The Child PTSD Symptom Scale (CPSS) is a 24-item self-report instrument that yields both a continuous severity score and a determination of likely PTSD diagnostic status according to symptom presence. 17 items corresponding to DSM-IV symptom criteria (and are assumed to yield a PTSD symptom severity score range 0-51) and 7 items assess impairment from those symptoms. The 17 symptom items were administered at baseline (prerandomization), with a score of 15 or greater considered a positive screen for PTSD risk (higher values represent more significant severity of and impairment from PTSD symptoms). The 24-item scale was administered at 6 weeks and 6 months postinjury to assess traumatic stress symptom outcomes.|6 months|85 children were randomly assigned to receive usual care (n=39) or the intervention (n=46, 5 did not go on to receive intervention). Of these subjects, 31 usual care subjects and 37 intervention subjects completed 6 month follow-up.||Units on a scale||Standard Deviation|Mean
738650|NCT00451282|Primary|PTSD Symptoms in Children 6 Weeks Post-injury|The Child PTSD Symptom Scale (CPSS) is a 24-item self-report instrument that yields both a continuous severity score and a determination of likely PTSD diagnostic status according to symptom presence. 17 items corresponding to of the Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV symptom criteria (and are assumed to yield a PTSD symptom severity score range 0-51) and 7 items assess impairment from those symptoms. The 17 symptom items were administered at baseline (prerandomization), with a score of 15 or greater considered a positive screen for PTSD risk (higher values represent more significant severity of and impairment from PTSD symptoms). The 24-item scale was administered at 6 weeks and 6 months postinjury to assess traumatic stress symptom outcomes.|6 weeks|85 children were randomly assigned to receive usual care (n=39) or the intervention (n=46, 5 did not go on to receive intervention). Of these subjects, 28 usual care subjects and 36 intervention subjects completed 6 week follow-up.||Units on a scale||Standard Deviation|Mean
738651|NCT00451451|Secondary|Proportion of Subjects Experiencing Progression of Disability Assessed Using the Expanded Disability Status Scale (EDSS)|EDSS is based on a standardized neurological exam and focuses on symptoms that commonly occur in MS. Scores range from 0.0 (normal) to 10.0 (death due to MS). Disability progression was defined as ≥ 1.0 point increase in subjects with a baseline EDSS of ≥1.0, or ≥1.5 point increase in subjects with a baseline EDSS=0, and required that the increase from baseline was confirmed ≥ 12weeks later. The proportion of subjects with confirmed (12-week) disability progression was estimated using the Kaplan-Meier method, which was based on the time-to-first-progression survival distribution|2 years|The analysis population consisted of the intent-to-treat (ITT) population (all subjects who were randomized and received at least 1 dose of study treatment) who had a baseline EDSS assessment. Analyses were based on all observed data. Onset of disability progression must begin before a subject switched to alternative MS medication.||Proportion of Participants|||Number
738652|NCT00451451|Secondary|Proportion of Subjects Relapsed|A protocol-defined relapse was defined as new or recurrent neurologic symptoms not associated with fever or infection that lasted at least 24 hours, and were separated by at least 30 days from onset of a preceding relapse. All protocol-defined relapses were evaluated by an independent neurologic evaluation committee. The proportion of subjects with a relapse was estimated using the Kaplan-Meier method, which was based on the time-to-first-relapse survival distribution.|2 years|The analysis was based on the ITT population, defined as all subjects who were randomized and received at least 1 dose of study treatment. Among subjects who switched to an alternative therapy for MS, all the data before the switch were used for the analysis. In all other subjects, all relapses were included in the analysis.||Proportion of subjects,confirmed relapse|||Number
738653|NCT00451451|Secondary|Number of New T1 Hypointense Lesions|The number of new T1 hypointense lesions at 2 years that developed in each subject compared to baseline assessed on brain magnetic resonance imaging (MRI) scans. The estimates of mean T1 hypointense lesion count were calculated from a negative binomial regression model adjusted for region and baseline T1 hypointense lesion volume.|2 years|Of the 681 subjects in the MRI cohort, 573 (139 placebo,140 BG00012 BID,140 BG00012 TID,154 GA) had post-baseline new T1 hypointense data & were included in the analysis. Missing data before the use of alternative MS medications & visits after subjects switched to alternative MS medications were imputed with the use of a constant rate assumption||Number of lesions||95% Confidence Interval|Mean
738654|NCT00451451|Secondary|Number of New or Newly Enlarging T2 Hyperintense Lesions|The number of new or newly enlarging T2 hyperintense lesions at 2 years that developed in each subject compared to baseline assessed on brain magnetic resonance imaging (MRI) scans. The estimates of mean T2 hyperintense lesion count were calculated from a negative binomial regression model adjusted for region and baseline T2 hyperintense lesion volume.|2 years|Of the 681 subjects in the MRI cohort, 572 (139 placebo, 140 BG00012 BID, 140 BG00012 TID, 153 GA) had post-baseline T2 hyperintense data & were included in the analysis. Missing data before the use of alternative MS medications & visits after subjects switched to alternative MS medications were imputed with the use of a constant rate assumption.||Number of lesions||95% Confidence Interval|Mean
738655|NCT00451451|Primary|Annualized Relapse Rate|"A protocol-defined relapse was defined as new or recurrent neurologic symptoms not associated with fever or infection that lasted at least 24 hours, and were separated by at least 30 days from onset of a preceding relapse. All protocol-defined relapses were evaluated by an independent neurologic evaluation committee.
The adjusted annualized relapse rate was calculated from a negative binomial regression model , adjusted for baseline Expanded Disability Status Scale (EDSS ) score(≤2.0 versus>2.0), age (<40 versus ≥40 years), region, and the number of relapses in the 1 year prior to enrollment."|2 years|The intent-to-treat (ITT) population was defined as all subjects who were randomized and received at least 1 dose of study treatment. Among subjects who switched to an alternative therapy for multiple sclerosis, all the data before the switch were used for the analysis. In all other subjects, all relapses were included in the analysis.||Relapses Per Year||95% Confidence Interval|Mean
738656|NCT00451698|Secondary|Length of Hospitalization||at hospital discharge|||days||Standard Deviation|Mean
738657|NCT00451698|Secondary|Inotropic Support||24 and 48 hours post operative||||||
738658|NCT00451698|Primary|Echocardiographic Assessment of Heart Function||24 hours postop||||||
738659|NCT00451698|Primary|Biochemical Markers of Neuron Damage||4 postoperative time points||||||
738660|NCT00451698|Primary|Biochemical Markers of Heart Damage|Troponin I levels (ng/ml) measured at 4 time points|4 postoperative time points|||ng/ml||Standard Deviation|Mean
738661|NCT00451906|Secondary|Number of Participants With Central Nervous System Bleeding|The incidence of central nervous system (CNS) bleeding was reported for participants who developed CNS metastases during the study period and who did not have Computed Tomography (CT) or magnetic resonance imaging (MRI) techniques of the head performed at baseline.|Up to 3 years|The ITT population was used for analysis, which included all participants with at least one valid post-baseline (Day -28 to -1) assessment. n = number of participants available at the time of assessment who were included in the analysis.||participants|||Number
738662|NCT00451906|Secondary|Time to Disease Progression|Time to disease progression was defined as time between first bevacizumab administration and date of first occurrence of progressive disease. Participants who had not progressed at the time of study completion (including participants who died before progressive disease) or who were lost to follow-up were censored at the last bevacizumab administration date. Progressive disease is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Time to disease progression was assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0.|Up to 3 years|The ITT population was considered for analysis, which included all participants with at least one valid post-baseline (Day -28 to -1) assessment. Participants available at the time of assessment were included in the analysis.||Months||95% Confidence Interval|Median
738663|NCT00451906|Secondary|Duration of Overall Survival|Overall survival time was defined as time between first bevacizumab administration and date of death, irrespective of the cause of death. Participants for whom no death was captured on the clinical database were censored at the most recent date they were known to be alive.|Up to 3 years|The ITT population included all participants with at least one valid post-baseline (Day -28 to -1) assessment. Participants available at the time of assessment were included in the analysis.||Months||95% Confidence Interval|Median
738664|NCT00451906|Primary|Number of Participants With Serious Adverse Events Related to Bevacizumab|Participants with serious adverse events (SAEs) related to bevacizumab were reported for the duration of the study.|Up to 3 years|The ITT population included all participants with at least one valid post-baseline (Day -28 to -1) assessment.||participants|||Number
738665|NCT00451906|Primary|Number of Participants With Adverse Events of Special Interest|Participants with adverse events (AEs) of special interest (hypertension, proteinuria, wound healing complications, gastrointestinal perforation, arterial and venous thromboembolic events, hemoptysis, Central Nervous System (CNS) bleeding, other hemorrhage events and congestive heart failure) were reported.|Up to 3 years|The ITT population included all participants with at least one valid post-baseline (Day -28 to -1) assessment.||participants|||Number
738666|NCT00451958|Secondary|Serum Levels of Follicle Stimulating Hormone (FSH) From the Time of Switch From Leuprolide to Degarelix to Day 56||From time of switch to Day 56|All participants who received leuprolide in the main CS21 study (NCT00295750) and were switched over to degarelix in the CS21A extension study.||International units/Liter (IU/L)||Full Range|Median
738667|NCT00451958|Secondary|Serum Levels of Luteinizing Hormone (LH) From the Time of Switch From Leuprolide to Degarelix to Day 56||From time of switch to Day 56|All participants who received leuprolide in the main CS21 study (NCT00295750) and were switched over to degarelix in the CS21A extension study.||International units/Liter (IU/L)||Full Range|Median
738668|NCT00451958|Secondary|Serum Levels of PSA From the Time of Switch From Leuprolide to Degarelix to Day 56||From time of switch to Day 56|All participants who received leuprolide in the main CS21 study (NCT00295750) and were switched over to degarelix in the CS21A extension study.||ng/mL||Full Range|Median
738669|NCT00451958|Secondary|Serum Levels of Testosterone From the Time of Switch From Leuprolide to Degarelix up to Day 56||From time of switch to Day 56|All participants who received leuprolide in the main CS21 study (NCT00295750) and were switched over to degarelix in the CS21A extension study.||ng/mL||Full Range|Median
738670|NCT00451958|Secondary|Percentage of Participants With Testosterone Level Maintained at <=0.5 ng/mL From Day 28 in CS21 and Onwards|"The results below present the percentage of participants of having testosterone <=0.5 ng/mL at each of the selected time points (there were more time points in the study) from Day 28 in CS21 (NCT00295750) until the end of the CS21A study.
In all treatment groups approximately 3% per year of the participants had at least one testosterone >0.5 ng/mL during the study."|Until all participants have received at least 5 years of treatment and at a frequency of every 6 months|CS21 ITT analysis set i.e. all participants who received at least one dose of degarelix or leuprolide during the mail CS21 study (NCT00295750).||percentage||95% Confidence Interval|Number
738671|NCT00451958|Secondary|Percentage of Participants With no Prostate-specific Antigen (PSA) Progression|PSA progression was defined as two consecutive increases of 50%, and at least 5 ng/mL, compared to nadir (obtained in either CS21, NCT00295750, or CS21A). The figures below present the percentage of participants with no PSA progression at each of the selected time points (there were more time points in the study) along with corresponding 95% confidence intervals (CI).|Until all participants have received at least 5 years of treatment and at a frequency of every 3 months|CS21 ITT analysis set i.e. all participants who received at least one dose of degarelix or leuprolide during the mail study (CS21).||percentage of participants||95% Confidence Interval|Number
738672|NCT00451958|Primary|Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables|This outcome measure included incidence of markedly abnormal changes in safety laboratory values. The table presents the number of participants with normal baseline (from main CS21 trial, NCT00295750) and at least one post-baseline markedly abnormal value during CS21A. Only the laboratory variables that had at least five percentages of participants in either group with abnormal value are presented, more variables were included in the study. ULN=Upper limit of normal.|Up to 4 years of treatment|The analysis population comprised all participants who were enrolled in the CS21A study and who received at least one dose of degarelix during the study period.||participants|||Number
738673|NCT00451958|Primary|Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight|This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline (from main CS21 study, NCT00295750) and at least one post-baseline markedly abnormal value during CS21A.|Up to 4 years of treatment|The analysis population comprised all participants who were enrolled in the CS21A study and who received at least one dose of degarelix during the study period.||participants|||Number
738674|NCT00452114|Secondary|Peak Expiratory Cough Flow||12 months||||||
738675|NCT00452114|Secondary|Pulmonary Function: FEV1||12 months||||||
738676|NCT00452114|Secondary|Quality of Life (St. George's Respiratory Questionnaire, Cough-Specific Quality of Life Questionnaire)||12 months||||||
738677|NCT00452114|Primary|Number of Hospitalizations and Urgent/Unscheduled Outpatient Visits||12 months||||||
738678|NCT00452114|Primary|Number of Suppurative Exacerbations Per Patient Per Year||12 months|interim analysis indicates statistical futility for primary outcomes|||||
738689|NCT00452348|Secondary|Rate of Asthma Attacks Per Participant Per Year|The rate of asthma attacks was defined as the mean number of attacks per participant per year. An asthma attack was defined as a >=20% decrease in AM PEF, a >=70% increase in albuterol use, or the occurrence of an asthma exacerbation requiring oral steroids or hospitalization.|Week 1 through Week 52|ITT Population||attacks per participant per year||95% Confidence Interval|Mean
738690|NCT00452348|Secondary|Mean Change From Baseline in the Percentage of Symptom-free Days Over Weeks 1-52|A symptom-free day was defined as a day without asthma symptoms, as measured via the daily asthma symptom score (measuring symptoms during the day and previous night) on a 6-point scale (ranging from 0 to 5). A symptom score of 0=no symptoms, 1=symptoms for one short period, 2=symptoms for two or more short periods, 3=symptoms that did not affect normal daily activities, 4=symptoms that did affect normal daily activities, 5=symptoms so severe that daily activities could not be performed. Change from baseline was calculated as the average of the Week 1-Week 52 values minus the baseline value.|Baseline and Week 1 through Week 52|Participants in the ITT Population for which at least 1 week of diary data were provided||Percentage of symptom-free days||Standard Error|Mean
738691|NCT00452348|Secondary|Mean Change From Baseline in AM PEF Over Weeks 1-52|Morning (AM) peak expiratory flow (PEF) is defined as the maximum volume of air exhaled in liters per minute. Change from baseline was calculated as the average of the Week 1 through Week 52 values minus the baseline value.|Baseline and Week 1 through Week 52|Participants in the ITT Population who had a minimum of 1 week PEF values||Liters/minute (L/min)||Standard Error|Mean
738692|NCT00452348|Primary|Mean Change From Baseline in Pre-dose FEV1 Over Weeks 1-52|Pulmonary function was measured by forced expiratory volume in one second (FEV1), which is the volume of air exhaled from the lungs in one second. Change from baseline was calculated as the average of the Week 1 through Week 52 values minus the baseline value.|Baseline and Week 1 through Week 52|Intent-to-Treat (ITT) Population: all participants randomized to study drug who had at least one on-treatment FEV1||Liters||Standard Error|Mean
738693|NCT00452361|Secondary|Incidence and Severity of Biopsy-Confirmed Acute Rejection at Week 104||Week 104|Insufficient or no data available for efficacy analyses because study was terminated early.|||||
738694|NCT00452361|Secondary|Incidence and Severity of Biopsy-Confirmed Acute Rejection at Week 52||Week 52|Insufficient or no data available for efficacy analyses because study was terminated early.|||||
738695|NCT00452361|Secondary|Incidence and Severity of Biopsy-Confirmed Acute Rejection at Week 24||Week 24|Insufficient or no data available for efficacy analyses because study was terminated early.|||||
738696|NCT00452361|Secondary|Occurence of Acute Rejection or Premature Withdrawal From Study Medication for Any Reason by Week 104||Week 104|Insufficient or no data available for efficacy analyses because study was terminated early.|||||
738697|NCT00452361|Secondary|Occurence of Acute Rejection or Premature Withdrawal From Study Medication for Any Reason by Week 52||Weeks 52|Insufficient or no data available for efficacy analyses because study was terminated early.|||||
738698|NCT00452361|Secondary|Change From Baseline in the Severity and Progression of Biopsy-Confirmed Chronic Allograft Nephropathy (CAN) at Week 104||Baseline and Week 104|Insufficient or no data available for efficacy analyses because study was terminated early.|||||
738699|NCT00452361|Secondary|Change From Baseline in Systolic Blood Pressure at Week 104|Value at Week 104 minus value at baseline.|Baseline and Week 104|Insufficient or no data available for efficacy analyses because study was terminated early.|||||
738700|NCT00452361|Secondary|Change From Baseline in Systolic Blood Pressure at Week 52|Value at Week 52 minus value at baseline.|Baseline and Week 52|Insufficient or no data available for efficacy analyses because study was terminated early.|||||
738701|NCT00452361|Secondary|Change From Baseline in Systolic Blood Pressure at Week 24|Value at Week 24 minus value at baseline.|Baseline and Week 24|Insufficient or no data available for efficacy analyses because study was terminated early.|||||
738702|NCT00452361|Secondary|Change From Baseline in Diastolic Blood Pressure at Week 104|Value at Week 104 minus value at baseline.|Baseline and Week 104|Insufficient or no data available for efficacy analyses because study was terminated early.|||||
738703|NCT00452361|Secondary|Change From Baseline in Diastolic Blood Pressure at Week 52|Value at Week 52 minus value at baseline.|Baseline and Week 52|Insufficient or no data available for efficacy analyses because study was terminated early.|||||
738704|NCT00452361|Secondary|Change From Baseline in Diastolic Blood Pressure at Week 24|Value at Week 24 minus value at baseline.|Baseline and Week 24|Insufficient or no data available for efficacy analyses because study was terminated early.|||||
738705|NCT00452361|Secondary|Patient and Graft Survival|Patient survival defined as participants living with or without a functioning graft. Graft survival defined as those participants who did not experience graft loss. Graft loss defined as physical loss (nephrectomy), functional loss (necessitating maintenance dialysis for >8 weeks), retransplant or death during the first 12 months after randomization.|Week 104|Insufficient or no data available for efficacy analyses because study was terminated early.|||||
738706|NCT00452361|Secondary|Patient and Graft Survival|Patient survival defined as participants living with or without a functioning graft. Graft survival defined as those participants who did not experience graft loss. Graft loss defined as physical loss (nephrectomy), functional loss (necessitating maintenance dialysis for >8 weeks), retransplant or death during the first 12 months after randomization.|Week 52|Insufficient or no data available for efficacy analyses because study was terminated early.|||||
738707|NCT00452361|Secondary|Patient and Graft Survival|Patient survival defined as participants living with or without a functioning graft. Graft survival defined as those participants who did not experience graft loss. Graft loss defined as physical loss (nephrectomy), functional loss (necessitating maintenance dialysis for >8 weeks), retransplant or death during the first 12 months after randomization.|Week 24|Insufficient or no data available for efficacy analyses because study was terminated early.|||||
738708|NCT00452361|Secondary|Change in Glomerular Filtration Rate (GFR)|GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. GFR can be measured directly or estimated using established formulas. GFR was calculated using Nankivell formula. A normal GFR is > 90 mL/min, although children and older people usually have a lower GFR. Lower values indicate poor kidney function. A GFR <15 is consistent with kidney failure.|Baseline and Week 104|Insufficient or no data available for efficacy analyses because study was terminated early.|||||
738709|NCT00452361|Secondary|Change in Glomerular Filtration Rate (GFR)|GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. GFR can be measured directly or estimated using established formulas. GFR was calculated using Nankivell formula. A normal GFR is > 90 mL/min, although children and older people usually have a lower GFR. Lower values indicate poor kidney function. A GFR <15 is consistent with kidney failure.|Baseline and Week 52|Insufficient or no data available for efficacy analyses because study was terminated early.|||||
738710|NCT00452361|Secondary|Change in Glomerular Filtration Rate (GFR)|GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. GFR can be measured directly or estimated using established formulas. GFR was calculated using Nankivell formula. A normal GFR is > 90 mL/min, although children and older people usually have a lower GFR. Lower values indicate poor kidney function. A GFR <15 is consistent with kidney failure.|Baseline and Week 24|Insufficient or no data available for efficacy analyses because study was terminated early.|||||
738711|NCT00452361|Primary|Change in Glomerular Filtration Rate (GFR) Change From Baseline|GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. GFR can be measured directly or estimated using established formulas. GFR was calculated using Nankivell formula. A normal GFR is > 90 mL/min, although children and older people usually have a lower GFR. Lower values indicate poor kidney function. A GFR <15 is consistent with kidney failure.|104 weeks|No patients completed 104 weeks and therefore no data were available for efficacy analysis.|||||
738712|NCT00452374|Secondary|Number of Participants With a Complete Response or Partial Response|According to International Workshop Response Criteria for Non-Hodgkin's Lymphomas: Complete remission (CR) defined as > 30% lymphocytes in the bone marrow, recovery of blood counts and no clinical symptoms; and Partial remission (PR) defined as > 50% decrease of clinical symptoms from baseline and recovery from blood counts.|Evaluation every 3 cycles of treatment (28 days per cycle), approximately 90 days|||Participants|||Number
738713|NCT00452374|Primary|Maximum Tolerated Dose (MTD) Oxaliplatin|MTD defined as dose level at which 2/3 or 2/6 participants experience Dose Limiting Toxicity (DLT), where DLTs are any oxaliplatin-related ≥Grade 3 non-hematological toxicity involving a major organ system (brain, heart, kidney, liver, lung) in the National Cancer Institute (NCI) Version 3.0 toxicity scale.|From treatment onset to end of each cycle of treatment (every 21 days)|Of the 48 study participants, 19 were enrolled in the Phase I MTD group and included in the MTD analysis.||mg/m^2|||Number
738714|NCT00452387|Secondary|Median Overall Survival (OS)|Overall survival is defined as the time from treatment start until death from any cause. The median overall survival time is used to measure OS.|Overall survival was measured from day 1 of treatment until the end of treatment and then every 3 months thereafter until death.|||Months||95% Confidence Interval|Median
738715|NCT00452387|Secondary|Quality of Life (QoL)|The subject answers questions from the following 6 categories: general physical symptoms, treatment side effects, distress, despair, impaired performance, and impaired ambulation. Each question has a scale from 0 through 10, where 0 is not a problem and 10 is as bad as possible. The scores for the 6 categories are combined and normalized, and used to describe overall quality of life. Because normalized scores are created using a look-up index, there is no clearly defined maximum value. In practice, the maximum value for the combined scale is 73.5.|The Patient Care Monitor questionnaire was administered on day 1 of every cycle (approximately every 3 weeks) during study treatment.|||units on a scale||Full Range|Mean
738716|NCT00452387|Secondary|Correlation of Biochemical Criteria (PSA, Prostate-specific Antigen) With Objective Imaging|The test of association assesses the null hypothesis that the frequency of PSA response is the same for patients with and without a favorable imaging response. PSA response required a 50% reduction of the baseline PSA result that was confirmed three weeks later. Favorable imaging response is defined as stable disease, partial response, or complete response per RECIST guidelines. The Fisher’s exact test was used to test this hypothesis.|PSA was evaluated on day 1 of every cycle (approximately every 3 weeks) during study treatment. Radiologic imaging was repeated after every 4 cycles (approximately every 12 weeks) during study treatment.|||Participants|||Number
738717|NCT00452387|Primary|Median Time to Progression (TTP) by Imaging|Time to progression is defined as the time from treatment start until objective tumor progression. The median time to progression is the parameter used to describe TTP.|Radiologic imaging was repeated after every 4 cycles (approximately every 12 weeks) during study treatment.|Survival analysis was performed for 22 patients. However, the upper 95% confidence interval for median TTP could not be calculated and so the number of patients analyzed and the upper 95% confidence interval for median TTP could not be entered into the system.||Months||95% Confidence Interval|Median
738718|NCT00452400|Secondary|Laboratory Testing: Average Change From Baseline of Potassium|Laboratory testing: Average change from baseline of potassium measured on test-days. Pre−dose value on test day 1 is the baseline value.|Baseline and day 29|Treated set includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.||mmol/L||Inter-Quartile Range|Geometric Mean
738719|NCT00452400|Secondary|Clinical Relevant Abnormalities for Vital Signs, ECG and Physical Examination|Clinical relevant abnormalities for vital signs, ECG and physical examination. Any new or clinically relevant worsening of baseline conditions was reported as adverse events.|4 weeks|Treated set including all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.||participants|||Number
738720|NCT00452400|Secondary|Time From Dosing to the Maximum Concentration at Steady State (Tmax,ss)|tmax,ss represents the time from dosing to maximum concentration of olodaterol and olodaterol glucuronide in plasma at steady state.|Baseline and 4 weeks|All evaluable subjects. A subject was considered to be not evaluable if the subject had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||hours||Full Range|Median
738721|NCT00452400|Secondary|Maximum Concentration at Steady State (Cmax,ss)|Cmax,ss represents the maximum concentration of olodaterol and olodaterol glucuronide in plasma at steady state.|Baseline and 4 weeks|All evaluable subjects. A subject was considered to be not evaluable if the subject had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||Picogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
738832|NCT00463580|Secondary|The Correlation Coefficient Between Changes in HDRS Symptom Score(Measured Numerically and as the Ratio of Change Score to Baseline Score) and Changes in the Plasma Concentrations of TNF-alpha, IL-6 and CRP.||Between baseline and any study point||||||
738722|NCT00452400|Secondary|Area Under Curve From 0 to 24 Hours at Steady State (AUC0-24,ss)|AUC0-24,ss represents the area under the concentration curve of olodaterol and olodaterol glucuronide in plasma from 0 to time t=24 at steady state.|Baseline and 4 weeks|All evaluable subjects. A subject was considered to be not evaluable if the subject had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||Picogram*hours/milliliter||Geometric Coefficient of Variation|Geometric Mean
738723|NCT00452400|Secondary|Area Under Curve From 0 to 6 Hours at Steady State (AUC0-6,ss)|AUC0-6,ss represents the area under the concentration curve of olodaterol and olodaterol glucuronide in plasma from 0 to time t=6 at steady state.|Baseline and 4 weeks|All evaluable subjects. A subject was considered to be not evaluable if the subject had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||Picogram*hours/milliliter||Geometric Coefficient of Variation|Geometric Mean
738724|NCT00452400|Secondary|Area Under Curve From 0 to 3 Hours at Steady State (AUC0-3,ss)|AUC0-3,ss represents the area under the concentration curve of olodaterol and olodaterol glucuronide in plasma from 0 to time t=3 at steady state.|Baseline and 4 weeks|All evaluable subjects. A subject was considered to be not evaluable if the subject had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||Picogram*hours/milliliter||Geometric Coefficient of Variation|Geometric Mean
738725|NCT00452400|Secondary|Time From Dosing to the Maximum Concentration (Tmax)|tmax represents the time from dosing to maximum concentration of olodaterol and olodaterol glucuronide in plasma.|Baseline and 4 weeks|All evaluable subjects. A subject was considered to be not evaluable if the subject had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||hours||Full Range|Median
738726|NCT00452400|Secondary|Maximum Concentration (Cmax)|Cmax represents the maximum concentration of olodaterol and olodaterol glucuronide in plasma.|Baseline and 4 weeks|All evaluable subjects. A subject was considered to be not evaluable if the subject had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||Picogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
738727|NCT00452400|Secondary|Area Under Curve From 0 to 3 Hours (AUC0-3)|AUC0-3 represents the area under the concentration curve of olodaterol and olodaterol glucuronide in plasma from 0 to time t=3.|Baseline and 4 weeks|All evaluable subjects. A subject was considered to be not evaluable if the subject had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||Picogram*hours/milliliter||Geometric Coefficient of Variation|Geometric Mean
738728|NCT00452400|Secondary|Weekly Mean Number of Occasions of Rescue Therapy After 4 Weeks|Weekly mean number of occasions of rescue therapy used per day (PRN salbutamol (albuterol))|4 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Number of puffs||Standard Error|Least Squares Mean
738729|NCT00452400|Secondary|Weekly Mean Evening PEFR After 4 Weeks|Baseline PEFR was defined as the mean of the evening PEFR measurements obtained during the week just prior to first dose of randomized treatment.|4 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter/minute||Standard Error|Least Squares Mean
738730|NCT00452400|Secondary|Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) After 4 Weeks|Baseline PEFR was defined as the mean of the morning PEFR measurements obtained during the week just prior to first dose of randomized treatment.|4 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter/minute||Standard Error|Least Squares Mean
738731|NCT00452400|Secondary|Forced Expiratory Volume in 1 Second (FEV1) (Unsupervised) Area Under Curve 6-12 h (AUC 6-12h) Response After 4 Weeks|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Means are adjusted using a model with treatment (trt), baseline as fixed effects and centre as random effect. FEV1 AUC 6-12h was calculated from 6-12 hours post-dose using the trapezoidal rule, divided by the observation time (6h) to report in litres.|Baseline and 4 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
738732|NCT00452400|Secondary|Forced Expiratory Volume in 1 Second (FEV1) (Unsupervised) Area Under Curve 6-12 h (AUC 6-12h) Response After 2 Weeks|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Means are adjusted using a model with treatment (trt), baseline as fixed effects and centre as random effect. FEV1 AUC 6-12h was calculated from 6-12 hours post-dose using the trapezoidal rule, divided by the observation time (6h) to report in litres.|Baseline and 2 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
738733|NCT00452400|Secondary|Forced Expiratory Volume in 1 Second (FEV1) (Unsupervised) Area Under Curve 6-12 h (AUC 6-12h) Response After 1 Week|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Means are adjusted using a model with treatment (trt), baseline as fixed effects and centre as random effect. FEV1 AUC 6-12h was calculated from 6-12 hours post-dose using the trapezoidal rule, divided by the observation time (6h) to report in litres.|Baseline and 1 week|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
738734|NCT00452400|Secondary|Forced Expiratory Volume in 1 Second (FEV1) (Unsupervised) Area Under Curve 6-12 h (AUC 6-12h) Response at Day 1|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Means are adjusted using a model with treatment (trt), baseline as fixed effects and centre as random effect. FEV1 AUC 6-12h was calculated from 6-12 hours post-dose using the trapezoidal rule, divided by the observation time (6h) to report in litres.|baseline and day1|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
738833|NCT00463580|Secondary|Between Group Differences in Self-reported Depression Scores Measured by the IDS—SR||At any study point||||||
738735|NCT00452400|Secondary|Peak FEV1 (0-3h) Response After 2 Weeks|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with baseline, treatment and centre (centre random, all other effects fixed).|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
738736|NCT00452400|Secondary|Peak FEV1 (0-3h) Response After 1 Weeks|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with baseline, treatment and centre (centre random, all other effects fixed).|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to 30 min, 1 h, 2 h, and 3 h relative to dose after 1 week|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
738737|NCT00452400|Secondary|Peak FEV1 (0-3h) Response At Day 1|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment.Means are adjusted using a mixed effects model with baseline,treatment and centre (centre random, all other effects fixed).|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to 30 min, 1 h, 2 h, and 3 h relative to dose at day 1|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
738738|NCT00452400|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response at Week 2|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Means are adjusted using a model with treatment (trt), baseline as fixed effects and centre as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and 30 min, 1h, 2h, 3h relative to dose at Week 2|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
738739|NCT00452400|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response at Week 1|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Means are adjusted using a model with treatment (trt), baseline as fixed effects and centre as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and 30 min, 1h, 2h, 3h relative to dose at Week 1|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
738740|NCT00452400|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response at Day 1|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Means are adjusted using a model with treatment (trt), baseline as fixed effects and centre as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours postdose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and 30 min, 1h, 2h, 3h relative to dose at day 1|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
738741|NCT00452400|Secondary|Peak FVC (0-3h) Response After 4 Weeks|Peak (0-3h) will be the maximum post-dose value during the first 3 hours. Response is defined as change from the baseline value. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to 30 min, 1 h, 2 h, and 3 h relative to dose after 4 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
738742|NCT00452400|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-6 h (AUC 0-6h) Response at Week 4|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a model with treatment (trt), baseline as fixed effects and centre as random effect. FVC AUC 0-6h was calculated from 0-6 hours post-dose using the trapezoidal rule, divided by the observation time (6h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and 30 min, 1h, 2h, 3h, 4h, 5h, 6h relative to dose at Week 4|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
738743|NCT00452400|Secondary|Peak FEV1 (0-3h) Response After 4 Weeks|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with baseline, treatment and centre (centre random, all other effects fixed).|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to 30 min, 1 h, 2 h, and 3 h relative to dose after 4 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
738834|NCT00463580|Secondary|Between Group Difference in Percentage of Remitted Patients During Treatment (HDRS ≤7 or CGI of 1)||At any study point||||||
738835|NCT00463580|Secondary|Number of Patients With a 50% Reduction in HDRS Scores at Any Study Point||At any study point|||participants|||Number
738744|NCT00452400|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-6 h (AUC 0-6h) Response at Week 4|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Means are adjusted using a model with treatment (trt), baseline as fixed effects and centre as random effect. FEV1 AUC 0-6h was calculated from 0-6 hours post-dose using the trapezoidal rule, divided by the observation time (6h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and 30 min, 1h, 2h, 3h, 4h, 5h, 6h relative to dose at Week 4|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
738745|NCT00452400|Secondary|Trough FVC Response After 4 Weeks|Trough FVC was defined as the mean of the two values obtained at 1 hour and 10 minutes prior to the pulmonary function test maneuver. Response is defined as change from the baseline value. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment.|Baseline and 4 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
738746|NCT00452400|Secondary|Trough FVC Response After 2 Weeks|Trough FVC was defined as the mean of the two values obtained at 1 hour and 10 minutes prior to the pulmonary function test maneuver. Response is defined as change from the baseline value. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment.|Baseline and 2 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
738747|NCT00452400|Secondary|Trough FVC Response After 1 Week|Trough FVC was defined as the mean of the two values obtained at 1 hour and 10 minutes prior to the pulmonary function test maneuver. Response is defined as change from the baseline value. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment.|Baseline and 1 week|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
738748|NCT00452400|Secondary|Trough FEV1 Response After 2 Weeks|Trough FEV1 is defined as the mean of the two FEV1 values (performed at -1 hour and -10 minutes prior to test-drug inhalation) at the end of the dosing interval, 24 hours post-drug administration. Trough FEV1 response is defined as the change from baseline in trough FEV1. Baseline FEV1 is the mean of the two pre-treatment FEV1 values measured at Visit 2 (- 1 hour and - 10 minutes) prior to administration of the first dose of study medication.|Baseline and 2 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
738749|NCT00452400|Secondary|Trough FEV1 Response After 1 Week|Trough FEV1 is defined as the mean of the two FEV1 values (performed at -1 hour and -10 minutes prior to test-drug inhalation) at the end of the dosing interval, 24 hours post-drug administration. Trough FEV1 response is defined as the change from baseline in trough FEV1. Baseline FEV1 is the mean of the two pre-treatment FEV1 values measured at Visit 2 (- 1 hour and - 10 minutes) prior to administration of the first dose of study medication.|Baseline and 1 week|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
738750|NCT00452400|Primary|Trough FEV1 Response After 4 Weeks|Trough FEV1 is defined as the mean of the two FEV1 values (performed at -1 hour and -10 minutes prior to test-drug inhalation) at the end of the dosing interval, 24 hours post-drug administration. Trough FEV1 response is defined as the change from baseline in trough FEV1. Baseline FEV1 is the mean of the two pre-treatment FEV1 values measured at Visit 2 (- 1 hour and - 10 minutes) prior to administration of the first dose of study medication.|Baseline and 4 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
738751|NCT00452426|Secondary|Recovery Time (From Sedation)|Recovery time- time for patient to reach first of two consecutive MOAA/S of 5 from the time scope was removed.|"from scope out until first of two consecutive MOAA/S scores of 5"|This analysis was intention to treat (ITT) which is all subjects who enrolled and had data avaiable. The differences in total subjects enrolled and subjects analyzed are due to missing data.||minutes||Standard Deviation|Mean
738752|NCT00452426|Secondary|Clinician Satisfaction|Clinician Satisfaction with Sedation Instrument (CSSI) is a scale measuring the clinician satisfactin with the sedation they delivered. This validated scale consists of 16 questions that are scored and converted to a 0-100 scale, where 100 represented the most satisfied.|Post procedure|This analysis was intention to treat (ITT) which is all subjects who enrolled and had data avaiable. The differences in total subjects enrolled and subjects analyzed are due to missing data.||Scores on a scale||95% Confidence Interval|Mean
738753|NCT00452426|Secondary|Patient Satisfaction|Patient Satisfaction with Sedation Instrument (PSSI) is a scale measuring patient satisfactin with the sedation they received. This validated scale consists of 16 questions that are scored and converted to a 0-100 scale, where 100 represented the most satisfied.|24-48 hours post sedation|This analysis was intention to treat (ITT) which is all subjects who enrolled and had data avaiable. The differences in total subjects enrolled and subjects analyzed are due to missing data.||Scores on a scale||95% Confidence Interval|Mean
738754|NCT00452426|Secondary|Duration of Deep Sedation/General Anesthesia|Duration of Modified Observers Assessment of Alertness and Sedation (MOAA/S)score of 0 or 1 MOAA/S is a scale of numbers ranging from 0-5, 5 being defined as being awake or minimally sedatied, and 0 defined as being at the deepest level of sedation (general anethesia). The mean MOAA/S score was the sum of each subject's scores during the procedure divided by the number of non-missing scores.|From first dose until subject recovered from effects of sedation|This analysis was intention to treat (ITT) which is all subjects who enrolled and had data avaiable. The differences in total subjects enrolled and subjects analyzed are due to missing data.||minutes||Standard Deviation|Mean
738814|NCT00463437|Secondary|Number of Subjects With Anti-protein D Antibody Concentrations Above the Cut-off Value|Anti-protein D antibody cut-off value assessed was ≥ 100 Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per milliliter (EL.U/mL).|Before (pre) and one month after (post) the booster administration|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.||subjects|||Number
738755|NCT00452426|Primary|Area Under the Curve for Oxygen Desaturation (AUCDesat)|AUCDesat measures desaturation as a function of incidence, magnitude, and duration. AUCDesat is the difference between the threshold and actual oxygen saturation measured every second. The total area below the 90% threshold is summated to determine AUCDesat in units of seconds*percent.|From administration of initial drug dose until subject recovered from effects of sedation|This analysis was intention to treat (ITT) which is all subjects who enrolled and had data avaiable. The differences in total subjects enrolled and subjects analyzed are due to missing data.||seconds*percent of oxygen desaturation||95% Confidence Interval|Mean
738756|NCT00452452|Primary|Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups|GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|28 to 42 days after vaccination 3 for Group 1 (13 to <17 months of age), after vaccination 2 for Group 2 (14 to <26 months of age), and after vaccination 1 for Group 3 (26 to <73 months of age).|The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.||μg/mL||95% Confidence Interval|Geometric Mean
738757|NCT00452452|Secondary|Percentage of Participants Reporting Pre-Specified Systemic Events|Systemic events (fever ≥ 37.5 degrees Celsius [C], fever ≥ 38 C but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased appetite, irritability, increased sleep, decreased sleep, hives, use of medication to treat symptoms, and use of medication to prevent symptoms) were reported using an electronic diary. Participants may be represented in more than 1 category.|During the 4-day period after each dose|The safety population included all subjects who received at least 1 dose of vaccine.||percentage of participants|||Number
738758|NCT00452452|Secondary|Percentage of Participants Reporting Pre-Specified Local Reactions|Local reactions were collected using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.|During the 4-day period after each dose|The safety population included all participants who received at least 1 dose of vaccine.||percentage of participants|||Number
738759|NCT00452452|Primary|Percentage of Participants Achieving Antibody Level ≥0.35μg/mL After Vaccination|Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|28 to 42 days after vaccination 3 for Group 1 (13 to <17 months of age), after vaccination 2 for Group 2 (14 to <26 months of age), and after vaccination 1 for Group 3 (26 to <73 months of age).|Evaluable immunogenicity (per protocol) population who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate immunoglobulin G (IgG) antibody concentration to the given serotype.||percentage of participants||95% Confidence Interval|Number
738760|NCT00452530|Other Pre-specified|Summary of Laboratory Marked Abnormalities in Urinalysis Results During the Treatment Period-Treated Subjects With Available Measurements (Urinalysis)|preRX=pretreatment. Blood, urine: If missing preRx use ≥2, or if value ≥4, or if preRx=0 or 0.5 use ≥2, or if preRx=1 use ≥3, or if preRx=2 or 3 use ≥4; glucose, urine: If missing preRx use ≥2, or if value ≥4, or if preRx=0 or 0.5 use ≥2, or if preRx=1 use ≥3, or if preRx=2 or 3 use ≥4; protein, urine: If missing preRx use ≥ 2, or if value ≥4, or if preRx=0 or 0.5 use ≥2, or if preRx=1 use ≥3, or if preRx=2 or 3 use ≥4; Red blood cells , urine: If missing preRx use ≥2, or if value ≥4, or if preRx=0 or 0.5 use ≥2, or if preRx=1 use ≥3, or if preRx=2 or 3 use ≥4; white blood cells, urine: If missing preRx use ≥2, or if value ≥4, or if preRx=0 or 0.5 use ≥2, or if preRx=1 use ≥3, or if preRx=2 or 3 use ≥4.|Randomization to Days 2, 3, 4, and 12 (±2 days) and at Days 42 and 72 (± 5 days) of follow-up|All participants who received at least 1 dose of study drug. n=number of participants with available measurements||Participants|||Number
738761|NCT00452530|Other Pre-specified|Summary of Laboratory Marked Abnormalities in Electrolyte and Other Clinical Test Results During the Treatment Period (Patients With Available Measurements)|preRX=pretreatment; LLN=lower limit of normal; ULN=upper limit of normal. Calcium, total (mg/dL): <0.8*LLN or >1.2*ULN, or if preRx<LLN use <0.75*preRx or >ULN if preRx >ULN use >1.25*preRx or <LLN; chloride, serum (mEq/L): <0.9*LLN or >1.1*ULN, or if preRx<LLN use <0.9*preRx or >ULN if preRx>ULN use >1.1*preRx or <LLN; bicarbonate (mEq/L): <0.75*LLN or >1.25*ULN, or if preRx < LLN use <0.75*preRx or >ULN if preRx >ULN use >1.25*preRx or < LLN; potassium, serum (mEq/L): <0.9* LLN or >1.1*ULN, or if preRx<LLN use <0.9 *preRx or >ULN if preRx>ULN use >1.1*preRx or <LLN; sodium, serum (mEq/L): <0.95*LLN or >1.05*ULN, or if preRx <LLN use <0.95*preRx or >ULN if preRx>ULN use >1.05*preRx or <LLN; protein, total (g/dL): <0.9*LLN or >1.1*ULN, or if preRx <LLN use 0.9*preRx or >ULN if preRx >ULN use 1.1*preRx or <LLN; CK (U/L): >5*ULN; uric acid (mg/dL): >1.5*ULN, or if preRx >ULN use >2*preRx; glucose, fasting serum (mg/dL): <0.8*LLN or >1.5*ULN, or if preRx <LLN use <0.8*preRx or >ULN.|Randomization to Days 2, 3, 4, and 12 (±2 days) and at Days 42 and 72 (±5 days) of follow-up|All participants who received at least 1 dose of study drug. n=number of participants with available measurements||Participants|||Number
738762|NCT00452530|Other Pre-specified|Summary of Laboratory Marked Abnormalities on Hematology and Liver and Kidney Function Test Results During the Treatment Period (Patients With Available Measurements)|preRX=pretreatment; LLN=lower limit of normal; ULN=upper limit of normal; abs=absolute. Hemoglobin (g/dL): >2 decrease from preRx value or value <=8; hematocrit (%): <0.75*preRx; platelets: <100*10^9 cells/L; erythrocytes (*10^6 cells/μL): <0.75*preRx; leukocytes: <0.75*LLN or >1.25*ULN, or if preRx <LLN, use <0.8*preRx or >ULN if preRx >ULN use >1.2*preRx or <LLN; abs basophils: >400/mm^3; abs eosinophils: > 0.750*10^3 cells/µL; abs lymphocytes: <0.750*10*3 cells/ µL or >7.50*10^3 c/ µL; abs monocytes > 2000/mm^3; abs neutrophils: <1.0*10^3 cells/μL; ALP (U/L): >2*ULN; ALT, AST (U/L): >3*ULN; U/L; bilirubin, direct (mg/dL): >1.5*ULN; bilirubin, total (mg/dL): >2*ULN; BUN (mg/dL): >2*ULN; creatinine (mg/dL): >1.5*ULN.|Randomization to Days 2, 3, 4, and 12 (±2 days) and at Days 42 and 72 (±5 days) of follow-up|All participants who received at least 1 dose of study drug. n=number of participants with available measurements||Participants|||Number
738763|NCT00452530|Secondary|Number of Participants With Serious Adverse Events (SAE), Bleeding Adverse Events (AEs), Discontinuations Due to AEs, and Death as Outcome|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Bleeding AEs=all serious or nonserious bleeding-related AEs.|Days 1 through 12 + 2 days (nonserious AEs, bleeding AES) or 30 days (SAES, deaths) after last dose of study drug|All participants who received at least 1 dose of study drug||Participants|||Number
738764|NCT00452530|Primary|Rate of Adjudicated Venous Thromboembolic Event-related and All-cause Deaths With Onset During the Intended-treatment Period|Event rate=Number of events divided by the number of patients evaluated. Intended treatment period starts on the day of randomization, and for those who received study drug, ends at the later of 2 days after last dose or 14 days after the first dose of study drug; for randomized patients who did not receive study drug, the period ends 14 days after randomization.Venous thromboembolic event (VTE)=nonfatal pulmonary embolism (PE), symptomatic deep vein thrombosis (DVT), or asymptomatic proximal DVT detected by ultrasound. VTE-related death=fatal PE or sudden death for which VTE could not be excluded as a cause.|Day of randomization to later of 2 days after last dose or 14 days after first dose; 14 days after randomization for those who did not receive study drug|The primary efficacy data set (all randomized participants who, during the Intended Treatment Period, had an adjudicated and evaluable bilateral venogram, an adjudicated venous thrombolytic event; or died due to any cause.)||Percentage of events/patients evaluated||95% Confidence Interval|Number
738765|NCT00452530|Secondary|Rate of Major Bleeding, Clinically Relevant Nonmajor Bleeding (CRNM), and Major Bleeding or CRNM|Event rate=Number of events divided by number of patients evaluated. Adjusted difference of event rates takes into consideration type of surgery as a stratification factor. Bleeding Criteria: Major bleeding=an event consisting of clinically overt bleeding accompanied by a decrease in hemoglobin of 2 g/dL or more and/or a transfusion of 2 or more units of packed red blood cells; bleeding that occurred in at least 1 of the following critical sites: intracranial, intraspinal, intraocular (within the corpus of the eye; a conjunctival bleed is not an intraocular bleed), pericardial, intra-articular, intramuscular with compartment syndrome, and retroperitoneal; bleeding that was fatal. CRNM bleeding= clinically overt bleeding; that satisfies none of the additional criteria required for the event to be adjudicated as a major bleeding event; that led to either hospital admission for bleeding, physician-guided medical or surgical treatment for bleeding; or a change in antithrombic treatment.|Days 1 to 12|All participants who received at least 1 dose of study drug||Percentage of events/patients evaluated||95% Confidence Interval|Number
738766|NCT00452530|Secondary|Rate of Adjudicated Proximal Deep Vein Thrombosis (DVT), Nonfatal Pulmonary Embolism, and Venous Thromboembolic Event-related Death With Onset During the Intended Treatment Period|Event rate=Number of events divided by the number of patients evaluated. Intended treatment period starts on the day of randomization, and for those who received study drug, ends at the later of 2 days after last dose or 14 days after the first dose of study drug; for randomized patients who did not receive study drug, the period ends 14 days after randomization; for randomized patients who did not receive study drug, the period ends 14 days after randomization. Venous thromboembolic event (VTE)=nonfatal pulmonary embolism (PE), symptomatic DVT, or asymptomatic proximal DVT detected by ultrasound. VTE-related death=fatal PE or sudden death for which VTE could not be excluded as a cause.|Day of randomization to later of 2 days after last dose or 14 days after first dose; 14 days after randomization for those who did not receive study|Randomized participants with either an adjudicated and evaluable bilateral proximal venogram or an adjudicated event associated with the endpoint, during the Intended Treatment Period||Percentage of events/patients evaluated||95% Confidence Interval|Number
738767|NCT00452543|Primary|Total Drinks Consumed Per Drinking Day on the TLFB|Total Drinks Consumed per Drinking Day on the Time Line Follow Back. We measure the change from Baseline to Week 12 or week of early termination visit.|From Baseline visit to Week 12 (or early discontinuation visit)|||Drinks consumed per drinking day||Standard Deviation|Mean
738768|NCT00452543|Primary|Total Drinks Consumed Per Week on the TLFB|Total Drinks Consumed per Week on the Time Line Follow Back. We measure the change from Baseline to Week 12 or week of early termination visit.|From Baseline visit to Week 12 (or early discontinuation visit)|||Drinks consumed per week||Standard Deviation|Mean
738769|NCT00452543|Primary|Total Drinking Days on the Alcohol Timeline Followback (TLFB)|The TLFB assesses recent drinking behavior. On the TLFB, clients retrospectively estimate their daily alcohol consumption in standard drinks over a time period ranging from 7 days to 24 months prior to the interview, and thus the measure provides quantitative estimates of alcohol use. One standard drink on the TLFB was defined as: 12 oz beer (5% alcohol by volume), 5 oz of wine (10-12% abv), 3 oz of fortified wine (16-18% abv), or 1-1.2 oz of hard liquor (86-100 proof; 43-50% abv). We measure the change from Baseline to Week 12 or week of early termination visit.|From Baseline visit to Week 12 (or early discontinuation visit)|Intent to treat sample||Drinking days||Standard Deviation|Mean
738770|NCT00452543|Primary|Change in Mean Score on the Hamilton Rating Scale for Depression -- 17 Items (HAM-D-17)|Scores on the HAM-D-17 typically fall into the following ranges: a) Not depressed: 0-7; b) Mildly depressed: 7-15; c) Moderately depressed: 15-25; d) Severely depressed: over 25. A decrease of 50% or more in the Hamilton-D score is considered to be a positive response to treatment, while a score of 7 or less is considered typical of remission. We measure the change in total score from Baseline to Week 12 or week of early termination visit.|From baseline visit to Week 12 (or early discontinuation visit)|||Scores on a scale||Standard Deviation|Mean
738771|NCT00458211|Secondary|Antipsychotic Medication Costs||8 weeks||||||
738772|NCT00458211|Secondary|Insulin Level||8 weeks||||||
738773|NCT00458211|Secondary|HgbA1c||8 weeks||||||
738774|NCT00458211|Secondary|Barnes Akathisia Scale||8 weeks||||||
738775|NCT00458211|Secondary|MOS-COG||8 weeks||||||
738776|NCT00458211|Secondary|PETiT||8 weeks||||||
738777|NCT00458211|Secondary|CDSS||8 weeks||||||
738778|NCT00458211|Secondary|BACS||8 weeks||||||
738779|NCT00458211|Secondary|QTc|Time interval between Q and T waves on EKG corrected for pulse rate. Over 500 msec may be dangerous|8 weeks|||msec||Standard Deviation|Mean
738787|NCT00458237|Secondary|Clinical Response Rate|Best response on treatment was based on RECIST 1.0 criteria with overall clinical response defined as achieving stable disease (SD), partial response (PR) or complete response (CR). Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response. SD is neither CR/PR or progressive disease (PD). PD is at least a 20% increase in sum LD, takings as reference smallest sum LD since treatment started.|Disease assessments occurred every 9 weeks (3 cycles) on treatment. Treatment continued until disease progression or unacceptable toxicity. Median duration of treatment was 2.4 months.|The analysis dataset is comprised of patients treated at the MTD/dose level 2.||proportion of participants||90% Confidence Interval|Number
738788|NCT00458237|Primary|Maximum Tolerated Dose (MTD)|"The MTD is determined by the number of patients who experience a dose limiting toxicity (DLT). The MTD is defined as the highest dose at which fewer than one-third of patients experience a DLT. If no DLTs are observed, the MTD is not reached. Dose Limiting Toxicities (DLTs) were defined as follows (CTCAE v4.0):
Any grade 4 hematologic toxicity, excluding anemia.
Any grade 3 or 4 nonhematologic toxicity, except for nausea, vomiting, diarrhea, or hyperlipidemia that responds promptly (within 24 hours for nausea, vomiting, and diarrhea and within 1 week for hyperlipidemia) to appropriate treatment, and except for cardiac toxicity which will be assessed after 12 weeks of treatment.
Need to hold >1 dose of trastuzumab or > 7 doses of RAD001 within the first 3 weeks because of the presence of toxicity."|Cycle One (first 21 days of treatment)|The analysis dataset for the Phase I study is comprised of the two dose cohorts: Level 1 and 2.||participants with DLT|||Number
738789|NCT00458302|Secondary|Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Social Well-Being Subscale|The FAHI social well-being subscale. Each item is assessing the impact of HIV on physical well-being on a scale from 0 (not at all) to 5 (very much).|at baseline, week 48, 96 and 144|ITT: all randomised patients who had at least 1 dose of study medication, regardless of protocol adherence. A LOCF method was used for calculation.||points on a scale||Standard Error|Mean
738790|NCT00458302|Secondary|Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Physical Well-Being Subscale|The FAHI physical well-being subscale. Each item is assessing the impact of HIV on physical well-being on a scale from 0 (not at all) to 5 (very much).|at baseline, week 48, 96 and 144|ITT: all randomised patients who had at least 1 dose of study medication, regardless of protocol adherence. A LOCF method was used for calculation.||points on a scale||Standard Error|Mean
738791|NCT00458302|Secondary|Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Functional and Global Well-Being Subscale|The FAHI functional and global well-being subscale. Each item is assessing the impact of HIV on functional and global well-being on a scale from 0 (not at all) to 5 (very much).|at baseline, week 48, 96 and 144|ITT: all randomised patients who had at least 1 dose of study medication, regardless of protocol adherence. A LOCF method was used for calculation.||points on a scale||Standard Error|Mean
738792|NCT00458302|Secondary|Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Emotional Well-Being Subscale|The FAHI emotional well-being subscale. Each item is assessing the impact of HIV on emotional well-being on a scale from 0 (not at all) to 5 (very much).|at baseline, week 48, 96 and 144|ITT: all randomised patients who had at least 1 dose of study medication, regardless of protocol adherence. A LOCF method was used for calculation.||points on a scale||Standard Error|Mean
738793|NCT00458302|Secondary|Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Cognitive Function Subscale|The FAHI cognitive function subscale. Each item is assessing the impact of HIV on cognitive function on a scale from 0 (not at all) to 5 (very much).|at baseline, week 48, 96 and 144|ITT: all randomised patients who had at least 1 dose of study medication, regardless of protocol adherence. A LOCF method was used for calculation.||points on a scale||Standard Error|Mean
738794|NCT00458302|Secondary|Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Total Score|The FAHI is a validated health-related quality of life questionnaire. The questionnaire consist of 44 items and includes 5 functional scales (physical, social, emotional, functional and global well-being and cognitive function). Each item is assessing the impact of HIV on a scale from 0 (not at all) to 5 (very much).|at baseline, week 48, 96 and 144|ITT: all randomised patients who had at least 1 dose of study medication, regardless of protocol adherence. A LOCF method was used for calculation.||points on a scale||Standard Error|Mean
738795|NCT00458302|Secondary|Resistance Determinations|Number of patients with resistance mutations at any time point when a patient had a viral load > 50 copies/mL after randomization.|at each visit from baseline to week 144|ITT: all randomised patients who had at least 1 dose of study medication, regardless of their adherence to the protocol.||number of participants|||Number
738796|NCT00458302|Secondary|Mean Change From Baseline in CD4+ Cell Count|The mean change in CD4+ cell count from baseline was calculated with a last observation carried forward method; i.e. the last observed value was carried forward, irrespective of the reason for discontinuation.|at week 4, 12, 24, 36, 48, 60, 72, 84, 96, 112, 128, 144|ITT: all randomized patients who had at least 1 dose of study medication, regardless of their adherence to the protocol||number of cells/L (x10^6)||Standard Error|Mean
738797|NCT00458302|Secondary|Virological Response [Per Protocol (PP), TLOVR - Switch Equals Failure, <200 Copies/ml, Week 144]|Virological response is defined as the number of patients in the PP population with a plasma viral load < 200 HIV RNA copies/ml at Week 144. Treatment failure was defined as two consecutive HIV RNA levels ≥ 50 copies/mL, or discontinuation of randomised treatment (known as TLOVR). In addition, any switch in background nucleoside reverse transcriptase inhibitors (NRTIs) equaled failure* (referred to as a Switch Equals Failure analysis). *Discontinuations and rechallenge with NRTIs are taken into account until Week 144|week 144|PP population: all randomised patients who took study drug, and who did not deviate from the protocol. This excludes 13 patients with major protocol deviations.||Participants|||Number
738815|NCT00463437|Secondary|Number of Subjects With Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes Above the Cut-off Value|"Anti-pneumococcal antibody cut-off value assessed was ≥ 8.
The cross-reactive pneumococcal serotypes assessed include 6A and 19A."|Before (pre) and one month after (post) the booster administration|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.||subjects|||Number
738798|NCT00458302|Secondary|Virological Response [Intent To Treat (ITT), TLOVR - All Switches Included, < 50 Copies/ml, Week 144]|Virological response is defined as the number of patients in the ITT population with a plasma viral load < 50 HIV RNA copies/ml at Week 144. Treatment failure was defined as two consecutive HIV RNA levels ≥ 50 copies/mL, or discontinuation of randomised treatment (known as TLOVR). All switches included means that all data even after any changes of treatment were kept. *Discontinuations and rechallenge with NRTIs are taken into account until start of Week 144 window.|Week 144|ITT population: all randomised patients who took study drug, regardless of their compliance with the protocol.||participants|||Number
738799|NCT00458302|Secondary|Virological Response [Per Protocol (PP), TLOVR - Switch Equals Failure, < 50 Copies/ml, Week 144]|Virological response is defined as the number of patients in the PP population with a plasma viral load < 50 HIV RNA copies/ml at Week 144. Treatment failure was defined as two consecutive HIV RNA levels ≥ 50 copies/mL, or discontinuation of randomised treatment (known as TLOVR). In addition, any switch in background nucleoside reverse transcriptase inhibitors (NRTIs) equaled failure* (referred to as a Switch Equals Failure analysis). *Discontinuations and rechallenge with NRTIs are taken into account until Week 144|Week 144|PP population: all randomised subjects who took study drug, and who did not deviate from the protocol.This excludes 13 subjects with major protocol deviations.||participants|||Number
738800|NCT00458302|Secondary|Virological Response [Intent To Treat (ITT) - TLOVR, < 50 Copies/ml, Week 48]|Virological response is defined as the number of patients in the ITT population with a plasma viral load < 50 HIV RNA copies/ml at Week 48. Treatment failure was defined as two consecutive HIV RNA levels ≥ 50 copies/mL, or discontinuation of randomised treatment (known as TLOVR). In addition, any switch in background nucleoside reverse transcriptase inhibitors (NRTIs) equaled failure* (referred to as a Switch Equals Failure analysis). *Discontinuations and rechallenge with NRTIs are taken into account until start of Week 48 window|Week 48|ITT population: all randomised patients who took study drug, regardless of their compliance with the protocol.||participants|||Number
738801|NCT00458302|Primary|Virological Response [Per Protocol (PP) - Time to Loss of Virologic Response (TLOVR), < 50 Copies/ml, Week 48]|Virological response is defined as the number of patients in the PP population with a plasma viral load < 50 HIV RNA copies/ml at Week 48. Treatment failure was defined as two consecutive HIV RNA levels ≥ 50 copies/mL, or discontinuation of randomised treatment (known as TLOVR). In addition, any switch in background nucleoside reverse transcriptase inhibitors (NRTIs) equaled failure* (referred to as a Switch Equals Failure analysis). *Discontinuations and rechallenge with NRTIs are taken into account until Week 48|Week 48|PP population: all randomised patients who took study drug, and who did not deviate from the protocol.This excludes 10 patients with major protocol deviations.||participants|||Number
738802|NCT00458406|Primary|Change in Minutes of Use Per Night From Month 1 to Month 3|minutes of use per night at Month 3 minus minutes of use per night at Month 1|month 1, month 3|||minutes||Standard Deviation|Mean
738803|NCT00458406|Primary|Minutes of Use Per Night at Month 3|The number of minutes of use per night at Month 3.|3 Months|The study sample size of 45 in the Bi-Flex group and 15 in the CPAP group had 80% power to detect an effect size ≥ 0.85 with a 0.05 two-sided significance level. In addition, with this sample size, the 95% CI for the difference between the 2 means had a range of 1.282 SD.||minutes||Standard Deviation|Mean
738804|NCT00458406|Secondary|Pediatric Quality of Life (PedQL)||3 months||||||
738805|NCT00458406|Secondary|Change in NOSE Scale Score From Month 1 to Month 3|Change in the total Nasal Obstruction Symptom Evaluation (NOSE) scale score (Score at Month 3 minus Score at Month 1). This scale evaluates the severity of nasal obstructive symptoms. The scale ranges from 0-20, with a higher score indicating more nasal obstruction.|3 months|||units on a scale||Standard Deviation|Mean
738806|NCT00458406|Secondary|Change in ESS From Month 1 to Month 3|Change in the Epworth Sleepiness Scale (ESS) score from Month 1 to Month 3: (Score at Month 3 minus Score at Month 1). The ESS measures daytime sleepiness in certain situations e.g. sitting/reading, watching television, sitting inactive in public, as a passenger in a car for an hour without a break, lying down to rest in the afternoon when circumstances permit, sitting/talking with someone, sitting quietly after lunch, or in a car, while stopped for a few minutes in traffic. The scale ranges from a minimum of zero to 24, with higher scores indicating greater daytime sleepiness.|3 months|||units on a scale||Standard Deviation|Mean
738807|NCT00458406|Secondary|Obstructive Sleep Apnea (OSA) 18 Score||3 months||||||
738808|NCT00458406|Secondary|Change in Apnea Hypopnea Index (AHI; Number of Apneas and Hypopneas Per Hour of Sleep) From Month 1 to Month 3|Change in Apnea Hypopnea Index from Month 1 to Month 3. AHI at Month 3 minus AHI at Month 1.|3 months|The study sample size of 45 in the Bi-Flex group and 15 in the CPAP group had 80% power to detect an effect size ≥ 0.85 with a 0.05 two-sided significance level. In addition, with this sample size, the 95% CI for the difference between the 2 means had a range of 1.282 SD.||Apneas and Hypopneas/hr sleep||Full Range|Median
738809|NCT00458406|Secondary|Drop Out Rate|Number of drop-outs included subjects in which investigators were unable to obtain a final download from the device.|3 months|Power calculation: The study sample size of 45 in the Bi-Flex group and 15 in the CPAP group had 80% power to detect an effect size ≥ 0.85 with a 0.05 two-sided significance level. In addition, with this sample size, the 95% CI for the difference between the 2 means had a range of 1.282 SD.||participants|||Number
738810|NCT00458406|Primary|Minutes of Use Per Night at Month 1|The number of minutes of use per night at month 1.|1 month|The study sample size of 45 in the Bi-Flex group and 15 in the CPAP group had 80% power to detect an effect size ≥ 0.85 with a 0.05 two-sided significance level. In addition, with this sample size, the 95% CI for the difference between the 2 means had a range of 1.282 SD.||minutes||Standard Deviation|Mean
738811|NCT00463437|Secondary|Number of Subjects With Anti-polyribosyl-ribitol Phosphate Antibody Concentrations Above the Cut-off Value|Anti-polyribosyl-ribitol phosphate antibody cut-off value assessed was ≥ 0.15 µg/mL.|Before (pre) and one month after (post) the booster administration|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.||subjects|||Number
738812|NCT00463437|Secondary|Number of Subjects With Anti-meningococcal Polysaccharide C Antibody Concentrations Above the Cut-off Value|Anti-meningococcal polysaccharide C antibody cut-off value assessed was ≥ 0.3 µg/mL.|Before (pre) and one month after (post) the booster administration|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.||subjects|||Number
738816|NCT00463437|Secondary|Number of Subjects With Cross-reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value|"Anti-pneumococcal antibody cut-off value assessed was 0.05 microgram per milliliter (µg/mL).
The cross-reactive pneumococcal serotypes assessed include 6A and 19A."|Before (pre) and one month after (post) the booster administration|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.||subjects|||Number
738817|NCT00463437|Secondary|Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value|"Cut-off value for opsonophagocytic activity against pneumococcal antibody assessed was ≥ 8.
The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, 23F."|Before (pre) and one month after (post) the booster administration|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.||subjects|||Number
738818|NCT00463437|Secondary|Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value|"Anti-pneumococcal antibody concentration cut-off value assessed was 0.05 microgram per milliliter (µg/mL).
The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F."|Before (pre) and one month after (post) the booster administration|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.||subjects|||Number
738819|NCT00463437|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|From the beginning of the study up to the end of the extended 6-month safety follow-up period|||subjects|||Number
738820|NCT00463437|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|During the 31-day (Day 0-30) period after the booster vaccination|||subjects|||Number
738821|NCT00463437|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|During the 31-day (Day 0-30) period after the booster vaccination|||subjects|||Number
738822|NCT00463437|Secondary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed include drowsiness, fever, irritability, and loss of appetite.|During the 4-day (Day 0-3) period after the booster vaccination|Subjects from the Total Vaccinated cohort for whom data were available.||subjects|||Number
738823|NCT00463437|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling.|During the 4-day (Day 0-3) period after the booster vaccination|Subjects from the Total Vaccinated cohort for whom data were available.||subjects|||Number
738824|NCT00463437|Primary|Number of Subjects Reporting Fever Above 39.0 Degree Celsius (°C)|Fever was measured as rectal temperature.|During the 4-day (Day 0-3) period after the booster vaccination|Analysis was performed on the Total vaccinated cohort from Pn-HibC and Pr-HibC Groups on subjects for whom data were available.||subjects|||Number
738825|NCT00463567|Other Pre-specified|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 1 Hour to 4 Hour Post Morning Dose After 2 Weeks of Treatment|"Interim Analysis: Stage 1.
Spirometry was conducted according to internationally accepted standards. Standardized with respect to time (AUC 1h-4h) for FEV1 measurements taken from 1 hour to 4 hour post morning dose on Day 14. Standardized FEV1 AUC was calculated by the trapezoidal rule. Mixed model used baseline FEV1, FEV1 prior to and 30 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and 1 hour post inhalation of ipratropium as covariates."|Day 14, After 2 Weeks of treatment in Stage 1|Interim Intent-to-treat (ITT) population included participants in Stage 1 of the study who received at least one dose of study drug and for whom data were available for AUC 1h-4h FEV1 at Day 14. Missing data were imputed using last observation carried forward (LOCF).||Liters||Standard Error|Least Squares Mean
738826|NCT00463567|Other Pre-specified|Trough Forced Expiratory Volume in 1 Second (FEV1) Assessed by Spirometry 24 Hour Post Dose After 2 Weeks of Treatment|"Interim Analysis: Stage 1.
Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 h 10 min and the 23 h 45 min post dose values. Mixed model used baseline FEV1, FEV1 prior to and 30 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and 1 hour post inhalation of ipratropium as covariates."|Day 15, After 2 Weeks of treatment in Stage 1|Interim Intent-to-treat (ITT) population included participants in Stage 1 of the study who received at least one dose of study drug and for whom data were available for Trough FEV1 at Day 15. Missing data were imputed using last observation carried forward (LOCF).||Liters||Standard Error|Least Squares Mean
738827|NCT00463567|Secondary|"The Percentage of Days of Poor Control Reported Over the 26 Week Treatment Period"|"A Chronic Obstructive Pulmonary Disease (COPD) day of poor control was defined as any day in the participant's diary with a score ≥2 (moderate or severe) for at least 2 of 5 symptoms (cough, wheeze, production of sputum, color of sputum, breathlessness). Score for each symptom ranges from 0-3; a higher number indicates a more severe symptom. The model contained baseline percentage of “days of poor control” as well as FEV1 reversibility components as covariates."|up to 26 weeks|Intent to Treat population consisting of all participants in Stage 2 of the study who received at least one dose of study drug. Eligible participants for the analysis were those with ≥7 evaluable diary days in the baseline period and ≥30% evaluable diary days (at least 20 days) in total.||Percentage of days||Standard Error|Least Squares Mean
738828|NCT00463567|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) Assessed by Spirometry 24 Hour Post Dose After 12 Weeks of Treatment|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 h 10 min and the 23 h 45 min post dose values. Mixed model used baseline FEV1, FEV1 prior to and 30 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and 1 hour post inhalation of ipratropium as covariates.|after 12 weeks of treatment|Participants from the Intent to Treat Population of Stage 2 of the study who received at least one dose of study drug and for whom data was available for FEV1 at 12 weeks. Imputed with last observation carried forward.||Liters||Standard Error|Least Squares Mean
738836|NCT00463580|Primary|(Study Endpoint): Mean (SD) Hamilton Depression Rating Scale 17-item (HAM-D-17) Scores at Baseline and Each Post Baseline Time Point.|Hamilton Depression Rating Scale-17 item; Minimum score= 0 Maximum score= 54; Higher scores represent greater symptom severity|baseline and treatment weeks 1, 2, 4, 6, 8, 10 and 12|Power calculations were based on standard deviations derived from published literature of HAM-D scores in patients with TRD (60 participants,80% power). An intent-to-treat analysis using mixed-effects model for repeated measures was used to analyze change from baseline of HAM-D scores as a function of treatment, time, and their interaction.||scores on a scale||Standard Deviation|Mean
738837|NCT00463606|Secondary|Mean Percent Change From Baseline to the Final Visit in Total Cholesterol (Full Analysis Set)|The mean percent change from baseline to the final visit in total cholesterol, with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.|Baseline to 12 Weeks|Full Analysis Set was used and was defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for total cholesterol. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.||percent change||Standard Error|Mean
738838|NCT00463606|Secondary|Median Percent Change From Baseline to the Final Visit in High Sensitivity C-reactive Protein (hsCRP) (Full Analysis Set)|The median percent change from baseline to the final visit in high sensitivity C-reactive protein (hsCRP), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.|Baseline to 12 Weeks|Full Analysis Set was used and was defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for hsCRP. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.||percent change||Inter-Quartile Range|Median
738839|NCT00463606|Secondary|Mean Percent Change From Baseline to the Final Visit in Apolipoprotein B (ApoB) (Full Analysis Set)|The mean percent change from baseline to the final visit in apolipoprotein B (ApoB), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.|Baseline to 12 Weeks|Full Analysis Set was used and was defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for ApoB. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.||percent change||Standard Error|Mean
738840|NCT00463606|Secondary|Mean Percent Change From Baseline to the Final Visit in Very-low-density Lipoprotein Cholesterol (VLDL-C) (Full Analysis Set)|The mean percent change from baseline to the final visit in very-low-density lipoprotein cholesterol (VLDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.|Baseline to 12 Weeks|Full Analysis Set was used and was defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for VLDL-C. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.||percent change||Standard Error|Mean
738841|NCT00463606|Secondary|Mean Percent Change From Baseline to the Final Visit in Non-high-density Lipoprotein Cholesterol (Non-HDL-C), With ABT-335 135 mg in Combination With Rosuvastatin 5 mg Versus Rosuvastatin 5 mg Monotherapy (Full Analysis Set)|The mean percent change from baseline to the final visit in non-high-density lipoprotein cholesterol (non-HDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.|Baseline to 12 Weeks|Full Analysis Set was used and was defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for non-HDL-C. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.||percent change||Standard Error|Mean
738842|NCT00463606|Secondary|Mean Percent Change From Baseline to the Final Visit in Non-high-density Lipoprotein Cholesterol (Non-HDL-C), With ABT-335 135 mg in Combination With Rosuvastatin 5 mg Versus ABT-335 135 mg Monotherapy (Full Analysis Set)|The mean percent change from baseline to the final visit in non-high-density lipoprotein cholesterol (non-HDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus ABT-335 135 mg monotherapy.|Baseline to 12 Weeks|Full Analysis Set was used and was defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for non-HDL-C. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.||percent change||Standard Error|Mean
738843|NCT00463606|Primary|Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C) (Full Analysis Set)|The mean percent change from baseline to the final visit in low-density lipoprotein cholesterol (LDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus ABT-335 135 mg monotherapy.|Baseline to 12 Weeks|Full Analysis Set was used and was defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for low-density lipoprotein cholesterol. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.||percent change||Standard Error|Mean
738844|NCT00463606|Primary|Mean Percent Change From Baseline to the Final Visit in Triglycerides (Full Analysis Set)|The mean percent change from baseline to the final visit in triglycerides, with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.|Baseline to 12 Weeks|Full Analysis Set was used and was defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for triglycerides. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.||percent change||Standard Error|Mean
738845|NCT00463606|Primary|Mean Percent Change From Baseline to the Final Visit in High-density Lipoprotein Cholesterol (HDL-C) (Full Analysis Set)|The mean percent change from baseline to the final visit in High-density lipoprotein cholesterol (HDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.|Baseline to 12 Weeks|Full Analysis Set was used and was defined as all randomized participants who had both a baseline and at least 1 post-baseline value for high-density lipoprotein cholesterol. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.||percent change||Standard Error|Mean
739010|NCT00465088|Secondary|Percent Change in Non-HDL-C From Baseline to Week 8|(Week 8 non-HDL-C minus baseline non-HDL-C) x 100/baseline non-HDL-C|From baseline to Week 8|All treated subjects whose Week 8 value was obtained within the Week 8 visit window||percent change||95% Confidence Interval|Least Squares Mean
738846|NCT00463788|Secondary|Safety- Number of Participants Experiencing Any Adverse Event (AE)|Number of participants experiencing any AE. AEs: Any untoward medical occurrence in the form of signs, clinically significant abnormalities in laboratory findings, diseases, symptoms, or worsening of complications.|Time from first dose up to 30 days after last dose of study treatment, reported between day of first dose of study treatment, 20 June 2007, until cut-off date 05 April 2010|Safety population included all the participants who received at least 1 dose of study medication (that is cisplatin or cetuximab).||participants|||Number
738847|NCT00463788|Secondary|Time to Response (TTR)|The TTR was determined for participants whose confirmed BOR (based on RECIST) was either a CR or a PR . It was defined as the time from the first dose study treatment until the date of the first assessment of confirmed CR or PR.|Time from the first dose of study treatment (cetuximab or cisplatin) to first assessment of CR or PR, reported between day of first participant randomized, 20 June 2007, until cut-off date, 31 July 2009|FAS population included all participants who were randomized as described in the pre-assignment details.||months||95% Confidence Interval|Median
738848|NCT00463788|Secondary|Overall Survival (OS) Time|The OS time was defined as the time from randomization to death. Participants without event were censored at the last date known to be alive or at the clinical cut-off date, whatever was earlier.|Time from randomization to death or last day known to be alive, reported between day of first participant randomized, 20 June 2007, until cut-off date, 05 April 2010|FAS population included all participants who were randomized as described in the pre-assignment details.||months||95% Confidence Interval|Median
738849|NCT00463788|Secondary|Progression-Free Survival (PFS) Time|The PFS was defined as the duration from randomization until radiological progression according to investigator (based on RECIST) or death due to any cause. Only deaths within 85 days of last tumor assessment were considered. Participants without event were censored on the date of last tumor assessment.|Time from randomization to disease progression, death or last tumour assessment, reported between day of first participant randomized, 20 June 2007, until cut-off date, 31 July 2009|FAS population included all participants who were randomized as described in the pre-assignment details.||months||95% Confidence Interval|Median
738850|NCT00463788|Primary|Best Overall Response (BOR)|Percentage of participants with best overall (objective) response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST).|Evaluations were performed every 6 weeks until progression reported between day of first participant randomized, 20 June 2007, until cut-off date, 31 July 2009|FAS population included all participants who were randomized as described in the pre-assignment details.||percentage of participants||95% Confidence Interval|Number
738851|NCT00463801|Secondary|Evaluated Resource Utilization and Calculated Overall Treatment Cost (Including Treatment Period and Follow-up Period)||at day 14 and follow up day i.e. day 30||||||
738852|NCT00463801|Secondary|Safety Assessed by Hematological and Biochemical Tests, Urinalysis, and Recording and Follow-up of Emerging AE and SAE||At day 14||||||
738853|NCT00463801|Secondary|Efficacy Assessed by Time of Resolution of Infection|Time to resolution of signs and symptoms of infection, time to resolution of fever (oral or tympanic temperature ≤37.5°C).|At day 14||||||
738854|NCT00463801|Secondary|Efficacy Assessed by Duration of Treatment With Daptomycin Intravenous||At day 14||||||
738855|NCT00463801|Secondary|Efficacy Assessed as Percentage of Patients With Clinical Success at Day 4 and 10|To evaluate the efficacy of intravenous (IV) daptomycin in the treatment of complicated skin and soft tissue infections (cSSTI) caused by methicillin-resistant Staphylococcus aureus (MRSA), as assessed by measuring the clinical success rate achieved at the interim visits on day 4 (D4) and day 10 (D10) after treatment start. Clinical success is defined as complete resolution of signs and symptoms of infection, or clinical improvement, i.e. partial resolution of signs and symptoms so that no further antibacterial treatment was required.|At day 4 and 10||||||
738856|NCT00463801|Secondary|Efficacy Assessed as Success After 4, 7, 10 and 14 Days of Treatment With Daptomycin on Infecting Gram Positive Bacteria|To evaluate the microbiological efficacy of intravenous (IV) daptomycin in the treatment of complicated skin and soft tissue infections (cSSTI) caused by methicillin-resistant Staphylococcus aureus (MRSA), as assessed by measuring the proportion of patients achieving eradication of the Gram-positive baseline organisms at the study visits on D4, D7, D10, and D14. Microbiological success is documented eradication of baseline Gram-positive organism or presumed eradication defined as clinical success and no culture performed because of absence of drainage or other material for culture.|At day 4, 7, 10 and 14||||||
738857|NCT00463801|Primary|Proportion of Participants With Clinical Success at the Day 7 (D7) and Day 14 (D14) Visit After Treatment Start|Primary objective of the study was to evaluate the efficacy of intravenous (IV) daptomycin in the treatment of complicated skin and soft tissue infections (cSSTI) caused by methicillin-resistant Staphylococcus aureus (MRSA), as assessed by measuring the clinical success rate achieved at the day 7 and day 14 visit (D7, D14) after treatment start. Clinical success is defined as complete resolution of signs and symptoms of infection, or clinical improvement, i.e. partial resolution of signs and symptoms so that no further antibacterial treatment was required.|at Day 7 and 14|Intention to treat (ITT) and safety population: all patients who received at least one dose of study medication.||Participants|||Number
738858|NCT00463840|Secondary|Median Overall Survival|This is the time at which 50% of patients are alive from the trial entry .|up to 10 years since the start of the study||||||
738859|NCT00463840|Primary|Resectability After Chemoradiation|This is the number of patients whose tumors are resectable after the combination treatment of 5FU, oxaliplatin, and radiation (RT).|7.5 weeks|Based on intent-to-treat population.||participants|||Number
738860|NCT00463866|Secondary|Mean Cost Per Participant Per Country|Mean cost is calculated for each country using participants from the whole study and country specific costs. Mean value for the whole study can not be calculated.|6 months||||||
738861|NCT00463866|Secondary|The Mean Total Daily Dose of Steroids From Symbicort.|The mean total daily dose of steroids from Symbicort was calculated as the sum of the maintenance dose and the as-needed dose.|4 weeks|: Data for this measure recorded by 3874 participants in the Symbicort SMART 1*2 Reporting Group and recorded by 3873 participants in the Symbicort SMART 2*2 Reporting Group.||μg budesonide per day||Standard Deviation|Mean
739011|NCT00465088|Secondary|Percent Change in HDL-C From Baseline to Week 8|(Week 8 HDL-C minus baseline HDL-C) x 100/baseline HDL-C|From baseline to Week 8|All treated subjects whose Week 8 value was obtained within the Week 8 visit window||percent change||95% Confidence Interval|Least Squares Mean
738862|NCT00463866|Secondary|Mean Overall Asthma Control Questionnaire (ACQ) Score|The ACQ5 was used. The lower value the better with a full range from 0=no impairment, 6= maximum impairment. Awakenings, morning symptoms, limitations, shortness of breath and wheeze.|6 months.|Data for this measure recorded by 3709 participants in the Symbicort SMART 1*2 Reporting Group and recorded by 3735 participants in the Symbicort SMART 2*2 Reporting Group.||Scores in a scale||Full Range|Mean
738863|NCT00463866|Secondary|Percent of Participants With a Well Controlled Asthma Week.|The mean percent of participants fulfilling the criteria for a well controlled asthma week in each treatment. A well controlled asthma week is defined as a week with no exacerbations and no night-time awakenings due to asthma and a maximum of 2 days with symptoms and as-needed inhalation use.|6 months.|Data for this measure recorded by 3714 participants in the Symbicort SMART 1*2 Reporting Group and recorded by 3718 participants in the Symbicort SMART 2*2 Reporting Group.||Percentage of participants||Full Range|Mean
738864|NCT00463866|Secondary|Mean Daily Number of Inhalations of As-needed Medication.|The number of as-needed inhalations was measured 2 times during 2 weeks before 13 weeks and 26 weeks of treatment.|4 weeks|Inhalations of as-needed medication recorded by 3880 participants in the Symbicort SMART 1*2 Reporting Group and recorded by 3881 participants in the Symbicort SMART 2*2 Reporting Group||Inhalations per day per participant||Full Range|Mean
738865|NCT00463866|Secondary|Total Number of Days Per Participant With Oral/Systemic Glucocorticosteroids During Severe Asthma Exacerbation|Total number of days with oral/systemic glucocorticosteroids during severe exacerbation calculated for each participant. A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment.|6 months.|||Days per participant||Standard Deviation|Mean
738866|NCT00463866|Secondary|Total Number of Severe Asthma Exacerbations That Led to Hospitalisation and/or Emergency Room Treatment.|A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment. Number of events per participant|6 months.|||Number of events per participant||Full Range|Mean
738867|NCT00463866|Secondary|Fraction of Participants With Severe Asthma Exacerbation|The total number of severe asthma exacerbations was calculated for each participant. A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment.|6 months.|||Fraction of participants with event||95% Confidence Interval|Mean
738868|NCT00463866|Primary|Number of Severe Asthma Exacerbations Per Participant.|Time to first severe asthma exacerbation, translated to mean number of severe asthma exacerbations per participant. A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment.|6 months|||Severe exacerbations per participant||Full Range|Mean
738869|NCT00464087|Primary|The Primary Endpoint Will be in Hospital Major Bleed as Defined by the Study Protocol, Assessed at Three Time Points: After Study Drug Administration, But Prior to Randomization;After Randomization During PCI; and After PCI, Prior to Discharge|Characterized as fatal bleed, major bleed (SWITCH III criteria) or major bleed (OASIS criteria)|During hospitalization, after PCI|||participants|||Number
738870|NCT00464087|Primary|The Primary Endpoint Will be in Hospital Major Bleed as Defined by the Study Protocol, Assessed at Three Time Points: After Study Drug Administration, But Prior to Randomization;After Randomization During PCI; and After PCI, Prior to Discharge|Categorized as Fatal bleed, major bleed (SWITCH III criteria) or major bleed (OASIS criteria)|During hospitalization, after randomization, during PCI|||participants|||Number
738871|NCT00464087|Secondary|Secondary in Hospital Endpoint Will be In-hospital Death (Non-hemorrhagic Related), Vascular Access Site Complications, Myocardial Infarction, Need for Repeat Revascularization, Procedural Complication and Catheter Thrombosis|Characterized as death, access site complication, access site thrombus, hematoma, myocardial infarction, repeat vascularization, dissection, stent thrombosis, catheter thrombosis|during index hospitalization|||participants|||Number
738872|NCT00464087|Primary|The Primary Endpoint Will be in Hospital Major Bleed as Defined by the Study Protocol, Assessed at Three Time Points: After Study Drug Administration, But Prior to Randomization;After Randomization During PCI; and After PCI, Prior to Discharge|Characterized as Fatal bleed, Major bleed (SWITCH III criteria) or major bleed (OASIS criteria)|During hospitalization, after Fondaparinux administration, prior to randomization|||participants|||Number
738873|NCT00464204|Other Pre-specified|Changes in Renal Function: 3. Risk, Injury, Failure, Loss, End-stage Kidney Disease (RIFLE) Classification|"Risk, Injury, Failure, Loss, End-stage kidney disease (RIFLE) Classification in this study is based on serum creatinine values and renal replacement therapy, i.e. ignoring criteria based on urine output, as fulfilment of urine output criteria cannot be determined from the data collected in the study.
RIFLE comprises five categories: Risk (R), Injury (I), Failure (F), Loss (L), End-stage kidney disease (E) (worst outcome). R, I and F are based on increase in serum creatinine. L and E are based on administration of renal replacement therapy."|From screening to end of follow-up|Treated population (TRT) = all randomized patients treated with study drug||Participants|||Number
738874|NCT00464204|Other Pre-specified|Changes in Renal Function: 2. Acute Kidney Injury Network (AKIN) Classification|Acute Kidney Injury Network (AKIN) Classification in this study is based on serum creatinine values and renal replacement therapy, i.e. ignoring criteria based on urine output, as fulfilment of urine output criteria cannot be determined from the data collected in the study. AKIN ranges from stage 1 to stage 3 (worst outcome). Stages differ in serum creatinine increase. Stage 1: Increase ≥ 0.3mg/dL or ≥ 150%-200% from reference; Stage 2: Increase ≥ 200%-300% from reference; Stage 3: Increase >300% from reference with an acute increase of at least 0.5mg/dL or renal replacement therapy.|From screening to end of follow-up|Treated population (TRT) = all randomized patients treated with study drug||Participants|||Number
738875|NCT00464204|Other Pre-specified|Changes in Renal Function: 1. Acute Renal Failure (ARF) at Any Time After Screening|Acute Renal Failure (ARF) was defined as a two fold increase in serum concentration over the value at screening at any time after screening.|From screening to end of follow-up (up to day 90)|Treated population (TRT) = all randomized patients treated with study drug. Patients without ARF were excluded from analysis if they had no creatinine value at Screening or no post-screening creatinine value.||Participants|||Number
738876|NCT00464204|Other Pre-specified|Mortality|Mortality was reported for the time period from Screening until the end of follow-up.|From Screening to end of Follow-up|Treated population (TRT) = all randomized patients treated with study drug. Two patients in the Voluven® arm died due to non-treatment emergent SAEs.||Participants|||Number
738877|NCT00464204|Secondary|Area Under the Curve (AUC) of Sepsis-related Organ Failure Assessment (SOFA) Score Per Day From Screening to Day 4|"The Sepsis-related Organ Failure Assessment (SOFA) score in this study is reported for entire days, not for exact time points on a day. Potentially, more than one SOFA score may be available for the same day. In this case, the mean of the respective total scores was used for that day for calculation of Area Under the Curve (AUC).
The SOFA score includes sub-scores for Respiration, Coagulation, Liver, Cardiovascular, Central Nervous System and Renal function and may range from 0 (worst outcome) to 4 (best outcome)."|From Screening to Day 4|Full analysis set (FAS) = all randomized patients treated with study drug who reached hemodynamic stabilization||Scores on a scale||Standard Deviation|Mean
738878|NCT00464204|Secondary|Length of Stay in the Hospital|Length of stay was analysed in two approaches. First, it was calculated and analysed only for patients who did not die before end of study of the individual patient. As a sensitivity analysis, the analysis was carried out including patients who died with the maximum possible length of stay (i.e., the worst possible value).|Until discharge from hospital (up to Day 90)|"Full analysis set (FAS) = all randomized patients treated with study drug who reached hemodynamic stabilization.
Imputed with the longest possible duration for patients who died before end of the study of the individual patient."||Days||Standard Deviation|Mean
738879|NCT00464204|Secondary|Length of Stay in the Hospital|Length of stay was analysed in two approaches. First, it was calculated and analysed only for patients who did not die before end of study of the individual patient. As a sensitivity analysis, the analysis was carried out including patients who died with the maximum possible length of stay (i.e., the worst possible value).|Until discharge from hospital (up to day 90)|"Full analysis set (FAS) = all randomized patients treated with study drug who reached hemodynamic stabilization.
Calculated for patients who did not die before end of study of the individual patient."||Days||Standard Deviation|Mean
738880|NCT00464204|Secondary|Length of Stay in the ICU|Length of stay was analysed in two approaches. First, it was calculated and analysed only for patients who did not die before end of study of the individual patient. As a sensitivity analysis, the analysis was carried out including patients who died with the maximum possible length of stay (i.e., worst possible value).|Until discharge from ICU (up to Day 90)|"Full analysis set (FAS) = all randomized patients treated with study drug who reached hemodynamic stabilization.
Imputed with the longest possible duration for patients who died before end of the study of the individual patient."||Days||Standard Deviation|Mean
738881|NCT00464204|Secondary|Length of Stay in the Intensive Care Unit (ICU)|Length of stay was analysed in two approaches. First, it was calculated and analysed only for patients who did not die before end of study of the individual patient. As a sensitivity analysis, the analysis was carried out including patients who died with the maximum possible length of stay (i.e., the worst possible value).|Until discharge from ICU (up to day 90)|"Full analysis set (FAS) = all randomized patients treated with study drug who reached hemodynamic stabilization.
Calculated for patients who did not die before end of study of the individual patient"||Days||Standard Deviation|Mean
738882|NCT00464204|Secondary|Total Amount of Enteral Calories During the First Seven Days of Enteral Nutrition|This amount will be calculated from start of enteral nutrition until 7 am of day 8|7 days|Full analysis set (FAS) = all randomized patients treated with study drug who reached hemodynamic stabilization||kcal||Standard Deviation|Mean
738883|NCT00464204|Secondary|Time From Start of Fluid Resuscitation With Study Drug to Start of Enteral Nutrition After Hemodynamic Stabilization|Administration of enteral nutrition before initial hemodynamic stabilization was ignored in this analysis.|up to 48 hours|Full analysis set (FAS) = all randomized patients treated with study drug who reached hemodynamic stabilization||Hours||Standard Deviation|Mean
738884|NCT00464204|Secondary|Time From Start of Study Drug to Start of Enteral Nutrition in the Subgroup of Patients Who Received Enteral Nutrition|Time from start of fluid resuscitation with study drug to start of enteral nutrition.|Until start of enteral nutrition (up to 48 hours)|Full analysis set (FAS) = all randomized patients treated with study drug who reached hemodynamic stabilization||Hours||Standard Deviation|Mean
738885|NCT00464204|Secondary|Quantity of Study Drug in 4 Days|Total quantity of study drug infused over four consecutive days in the ICU|4 days|Full analysis set (FAS) = all randomized patients treated with study drug who reached hemodynamic stabilization||Milliliter||Standard Deviation|Mean
738886|NCT00464204|Secondary|Time From Start of Fluid Resuscitation With Study Drug to the Initial Hemodynamic Stabilization|Time from start of fluid resuscitation with study drug to the initial hemodynamic stabilization|until hemodynamic stabilization (up to 48 hours)|Full analysis set (FAS) = all randomized patients treated with study drug who reached hemodynamic stabilization||Hours||Standard Deviation|Mean
738887|NCT00464204|Primary|Amount of Study Drug Required to Achieve Initial Hemodynamic Stabilization|Initial hemodynamic stabilization (HDS) was defined as normalization of mean arterial pressure (MAP) and at least two of the three parameters central venous pressure (CVP), urine output and central venous oxygen saturation and maintaining this normalization over a period of four hours, with no increase in the infusion of vasopressors, or ionotropic therapy and with no more than 1 L of additional study drug administration within these four hours.|until hemodynamic stabilization (up to 48 hours)|Full analysis set (FAS) = all randomized patients treated with study drug who reached hemodynamic stabilization.||Milliliter||Standard Deviation|Mean
738894|NCT00464269|Secondary|Investigator's Global Evaluation Scale (I-GES) Evaluated at Last Visit or Early Discontinuation Visit|The Investigator's Global Evaluation Scale (I-GES) is a global assessment of the disease evolution which was performed using a seven-point scale (1 = Marked worsening to 7 = Marked improvement) with the start of the study medication as the reference time point. The investigator completed it by answering to the following: 'Assess the overall change in the severity of patient's illness, compared to start of study medication.'|Baseline to Last Visit or Early Discontinuation Visit in the 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.||percentage of participants|||Number
738888|NCT00464269|Secondary|Change From Baseline to the 12-week Treatment Period in Health Status of Life Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.|From Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.||units on a scale||Standard Deviation|Mean
738889|NCT00464269|Secondary|Change From Baseline to the 12-week Treatment Period in Overall Quality of Life Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.|From Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.||units on a scale||Standard Deviation|Mean
738890|NCT00464269|Secondary|Change From Baseline to the 12-week Treatment Period in Medication Effects Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.|From Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.||units on a scale||Standard Deviation|Mean
738891|NCT00464269|Secondary|Change From Baseline to the 12-week Treatment Period in Cognitive Functioning Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.|From Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.||units on a scale||Standard Deviation|Mean
738892|NCT00464269|Secondary|Change From Baseline to the 12-week Treatment Period in Emotional Well-Being Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.|From Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.||units on a scale||Standard Deviation|Mean
738893|NCT00464269|Secondary|Change From Baseline to the 12-week Treatment Period in Energy/Fatigue Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.|From Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.||units on a scale||Standard Deviation|Mean
738895|NCT00464269|Secondary|Patient's Global Evaluation Scale (P-GES) Evaluated at Last Visit or Early Discontinuation Visit|Patient's Global Evaluation Scale (P-GES) is a global assessment of the disease evolution which was performed using a seven-point scale (1= Marked worsening to 7 = Marked improvement) with the start of the study medication as the reference time point. The subject completed it by answering to the following: 'Overall, has there been a change in your seizures since the start of the study medication?'|Baseline to Last Visit or Early Discontinuation Visit in the 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.||percentage of participants|||Number
738896|NCT00464269|Secondary|Change From Baseline to the 12-week Treatment Period in Hospital Depression Score|The Hospital Anxiety and Depression Scale (HADS) was used to evaluate anxiety and depression. The HADS was developed as a self administered scale to assess the presence and severity of both anxiety and depression simultaneously. It consists of 14 items that are scored on a 4-point severity scale ranging from 0 to 3. A score per dimension was calculated with each score ranging from 0 to 21 and higher scores indicating higher depression / anxiety. A negative value in change from Baseline shows an improvement in HADS from Baseline.|Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.||units on a scale||Standard Deviation|Mean
738897|NCT00464269|Secondary|Change From Baseline to the 12-week Treatment Period in Hospital Anxiety Score|The Hospital Anxiety and Depression Scale (HADS) was used to evaluate anxiety and depression. The HADS was developed as a self administered scale to assess the presence and severity of both anxiety and depression simultaneously. It consists of 14 items that are scored on a 4-point severity scale ranging from 0 to 3. A score per dimension was calculated with each score ranging from 0 to 21 and higher scores indicating higher depression / anxiety. A negative value in change from Baseline shows an improvement in HADS from Baseline.|Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.||units on a scale||Standard Deviation|Mean
738898|NCT00464269|Secondary|Change From Baseline to the 12-week Treatment Period in Daily Activities / Social Functioning Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|"The Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-items subscales - seizure worry (5 items), overall quality of life (2 items), emotional well-being (5 items), energy / fatigue (4 items), cognitive functioning (6 items), medication effects (3 items), and social function (5 items) - and a health status item.
The subscale scores, the total score and the health status item score range from 0 to 100 and higher scores indicating better function."|Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.||units on a scale||Standard Deviation|Mean
738899|NCT00464269|Secondary|Change From Baseline to the 12-week Treatment Period in Seizure Worry Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|"The Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-items subscales - seizure worry (5 items), overall quality of life (2 items), emotional well-being (5 items), energy / fatigue (4 items), cognitive functioning (6 items), medication effects (3 items), and social function (5 items) - and a health status item.
The subscale scores, the total score and the health status item score range from 0 to 100 and higher scores indicating better function."|Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.||units on a scale||Standard Deviation|Mean
738900|NCT00464269|Secondary|Change From Baseline to the 12-week Treatment Period in Total Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|"The Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-items subscales - seizure worry (5 items), overall quality of life (2 items), emotional well-being (5 items), energy / fatigue (4 items), cognitive functioning (6 items), medication effects (3 items), and social function (5 items) - and a health status item.
The subscale scores, the total score and the health status item score range from 0 to 100 and higher scores indicating better function."|Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.||units on a scale||Standard Deviation|Mean
738901|NCT00464269|Secondary|Reduction of Type IC/Type I Seizure Frequency Ratio From Baseline to the 12- Week Treatment Period|The type IC/Type I seizure frequency ratio is represented by the percentage of subjects having a reduction in the ratio of Type IC seizure frequency over Type IA, IB, and IC seizure frequency from Baseline to Treatment Period.|Baseline to 12-week Treatment Period|"The Intention-to-treat (ITT) population was defined as all randomized subjects who received at least 1 dose of study medication.
Type IC Population consists of those subjects with at least one Type IC seizure during the Baseline period."||percentage of participants|||Number
738902|NCT00464269|Secondary|Time to Tenth Type I Seizure During the 12-week Treatment Period|The time to tenth Partial Onset Seizure (POS) in the Treatment Period is defined as the time between beginning of the Treatment Period and the date of occurrence of tenth Type I seizure. Subjects withdrawing during the Treatment Period before having a tenth Type I seizure were considered as having a tenth Type I seizure on the last day of their Treatment Period.|Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.||days||95% Confidence Interval|Median
738903|NCT00464269|Secondary|Time to Fifth Type I Seizure During the 12-week Treatment Period|The time to fifth Partial Onset Seizure (POS) in the Treatment Period is defined as the time between beginning of the Treatment Period and the date of occurrence of fifth Type I seizure. Subjects withdrawing during the Treatment Period before having a fifth Type I seizure were considered as having a fifth Type I seizure on the last day of their Treatment Period.|Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.||days||95% Confidence Interval|Median
738904|NCT00464269|Secondary|Time to First Type I Seizure During the 12-week Treatment Period|The time to first Partial Onset Seizure (POS) in the Treatment Period is defined as the time between beginning of the Treatment Period and the date of occurrence of first Type I seizure. Subjects withdrawing during the Treatment Period before having a first Type I seizure were considered as having a first Type I seizure on the last day of their Treatment Period.|Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.||days||95% Confidence Interval|Median
738905|NCT00464269|Secondary|Seizure Freedom Rate (All Seizure Types) Over the 12-week Treatment Period|"Subjects were considered seizure free if their seizure counts for every day over the Treatment Period (TP) was zero and if they did not discontinue before the end of the TP. Seizure freedom rate was calculated as:
(total number of seizure - free subjects in treatment group during TP)/(total number of evaluable Intent-To-Treat (ITT) subjects in treatment group)"|Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.||percentage of participants|||Number
738906|NCT00464269|Secondary|Categorized Percentage Change From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 12-week Treatment Period|"Subjects were classified in 1 of the following categories based on their percent reduction from Baseline to Treatment Period in Partial Onset Seizure (POS) frequency per week: <-25 %, -25 % to <25 %, 25 % to <50 %, 50 % to <75 %, 75 % to <100 %, and 100 %.
Subjects having zero for Baseline seizure frequency per week were classified in the <-25 % category."|Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.||percentage of participants|||Number
738907|NCT00464269|Secondary|Percent Change From Baseline to the 12-week Treatment Period in Partial Onset Seizure (Type I) Frequency Per Week|"Percent change from Baseline was calculated as percent reduction by:
(weekly seizure frequency Baseline - weekly seizure frequency Treatment)*100/(weekly seizure frequency Baseline).
The higher the values for percent change in Partial Onset Seizure (POS) frequency, the higher the improvement from Baseline."|Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.||Percent change in POS frequency||Inter-Quartile Range|Median
738908|NCT00464269|Secondary|All Seizure Frequency (Type I+II+III) Per Week Over the 12-week Treatment Period|"There are three different types of seizures:
Type I: Partial seizures
Type II: Generalized seizures
Type III: Unclassified epileptic seizures.
All seizure frequency per week over Treatment Period (TP) was calculated as: (Total number of seizures over the TP)*7/(Total number of days with no missing seizure count in the TP)"|Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.||seizures per week||Inter-Quartile Range|Median
738909|NCT00464269|Secondary|Responder Rate for Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period|The responder rate was presented as the number of responders and non-responders. A subject is a responder, if the subject has at least 50 % reduction in partial onset seizure frequency per week from Baseline to Treatment Period. Subjects with zero seizure frequency per week at Baseline were considered as non-responders.|Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.||participants|||Number
738910|NCT00464269|Primary|Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period|"Partial (Type I) seizures can be classified into one of the following three groups:
Simple partial seizures
Complex partial seizures
Partial seizures evolving to generalized tonic-clonic convulsions.
Partial Onset Seizure (POS) Frequency per week over the Treatment Period (TP) was calculated as:
(Total Type I seizures over the TP)*7/(Total number of days with no missing seizure count in the TP)"|Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.||seizures per week||Inter-Quartile Range|Median
738911|NCT00464308|Secondary|The Mean Percentage of Participants With 24-hour Heartburn Symptom Free Periods||4 weeks|||percent of participants||95% Confidence Interval|Mean
738912|NCT00464308|Primary|The Number of Patients Achieving Satisfactory Resolution of Regurgitation Symptoms by Week 4|Satisfactory resolution, which is achieved if, on any 7 consecutive days within the 4 week period, the severity of symptoms never exceeds ‘mild’ (symptoms must be absent, very mild, or mild)assessed by the PAGI-SYM scale. This likert scale describes a series of symptoms as follows: 0-None, 1-Very Mild, 2-Mild, 3-Moderate, 4-Severe, 5 Very Severe.|4 weeks|||participants|||Number
738913|NCT00464308|Primary|The Number of Patients Achieving Satisfactory Resolution of Heartburn by Week 4|Satisfactory resolution, which is achieved if, on any 7 consecutive days within the 4 week period, the severity of symptoms never exceeds ‘mild’ (symptoms must be absent, very mild, or mild) assessed by the PAGI-SYM scale. This likert scale describes various symptoms as follows: 0-none, 1-Very Mild, 2-Mild, 3-Moderate, 4-Severe, 5-Very Severe.|4 weeks|Symptom scores 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, 5=very severe||participants|||Number
738914|NCT00464308|Primary|The Number of Patients Achieving Complete Resolution of Regurgitation Symptoms at Week 4|Complete resolution is the absence of symptoms for any 7 consecutive days within the 4 week period assessed by the PAGI-SYM scale. This likert scale describes various symptoms as follows: 0-none, 1-Very Mild, 2-Mild, 3-Moderate, 4-Severe, 5-Very Severe.|4 weeks|||participants|||Number
738915|NCT00464308|Secondary|The Median Time to Complete Relief of Regurgitation Symptoms||4 weeks|ITT population||days||95% Confidence Interval|Median
738916|NCT00464308|Secondary|The Median Time to Complete Resolution of Heartburn Symptoms.||week 4 of treatment|ITT population||days||95% Confidence Interval|Median
738917|NCT00464308|Primary|The Number of Patients With Complete Resolution of Heartburn by Week 4|Complete resolution is the absence of symptoms for any 7 consecutive days within the 4 week period assessed by the PAGI-SYM scale. This likert scale describes a series of symptoms as follows: 0-None, 1-Very Mild, 2-Mild, 3-Moderate, 4-Severe, 5 Very Severe.|week 4 of treatment|The intent-to-treat (ITT) population was used for all efficacy analyses. The data were reanalysed using the compliance population (defined as all subjects who consumed at least 80% of study medication and who completed at least 80% of data recording).||participants|||Number
738918|NCT00464334|Primary|Mean Fold Change From Baseline in GMT of Aβ Peptide 1-40 Specific Antibodies|The Aβ Peptide 1-40 specific immunogenicity of 3-dose regimen of V950 was measured one month after the third dose (Month 7) of vaccine by the GMT fold change of Aβ 1-40 specific antibodies compared to Baseline (Month 0) using ELISA.|Baseline and Month 7|Population consists of all participants who received three doses of vaccine and had no protocol violations. No participants in the V950 50 mcg/IMX 0 mcg group had data for the Month 7 evaluation.||fold change||95% Confidence Interval|Geometric Mean
738919|NCT00464334|Primary|Geometric Mean Titer (GMT) of Amyloid Beta (Aβ) Peptide 1-40 Specific Antibodies at Month 7|The level of Aβ Peptide 1-40 specific antibodies was measured as the geometric mean titer (GMT) one month after the third dose (Month 7) of vaccine using an enzyme-linked immunosorbent assay (ELISA).|Month 7|Population consists of all participants who received three doses of vaccine and had no protocol violations. No participants in the V950 50 mcg/IMX 0 mcg group had data for the Month 7 evaluation.||ng/mL||95% Confidence Interval|Geometric Mean
738920|NCT00464334|Primary|Number of Participants Who Discontinued Study Drug Due to an Adverse Event|This is a measure of the number of participants who discontinued study drug because of an adverse event. An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.|Up to 6 months after first dose of vaccine|Population consists of all participants who received at least one dose of vaccine.||participants|||Number
738921|NCT00464334|Primary|Number of Participants Who Experienced at Least One Adverse Event|An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.|Up to 4 years after first dose of vaccine|Population consists of all participants who received at least one dose of vaccine.||participants|||Number
738922|NCT00464438|Secondary|Percentage of Patients With Improvement in Ocular Signs for Conjunctival Discharge at Day 7|"Percentage of patients with at least a 1-grade improvement in ocular signs for conjunctival discharge at Day 7 from Day 1 (Baseline). Conjunctival discharge was assessed on a 4-point severity grade scale (0=none, +1=mild, +2=moderate,
+3=severe)."|Day 7|"Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria"||Percentage of Patients|||Number
738923|NCT00464438|Secondary|Percentage of Patients With Improvement in Ocular Signs for Lid Erythema|Percentage of patients with at least a 1-grade improvement in ocular signs for lid erythema at Day 7 from Day 1 (Baseline). Lid erythema was assessed on a 4-point severity grade scale (0=none, +1=mild, +2=moderate, +3=severe).|Days 7|"Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria"||Percentage of Patients|||Number
738924|NCT00464438|Secondary|Percentage of Patients With Microbiological Improvement|Percentage of patients with microbiological improvement, defined such that all bacteria present above threshold at Day 1 (Baseline) are eradicated (absent) or reduced at Day 7 based on a Classification of Microbial Response (Eradication=pathogen is absent in follow-up culture; Reduction=pathogen is reduced from baseline below threshold count in follow-up culture; Persistence=pathogen reduced from baseline but is above or equal to threshold count in follow-up culture; and Proliferation=pathogen has increased in count from baseline in follow-up culture).|Day 7|"Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria"||Percentage of Patients|||Number
738925|NCT00464438|Primary|Percentage of Patients With Clearing (Clinical Success) of Conjunctival Erythema and Conjunctival Discharge at Day 7|Percentage of patients that achieved clinical success, defined as a score of 0 for both conjunctival erythema and conjunctival discharge at Day 7. Conjunctival erythema and conjunctival discharge were each assessed on a 4-point severity grade scale (0=none, +1=mild, +2=moderate, +3=severe).|Day 7|"Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria."||Percentage of Patients|||Number
738926|NCT00464464|Primary|Hamilton Depression Rating Scale: Follow-Up Evaluation|"This measure uses the Hamilton Depression Rating Scale (HDRS) to express the average severity of depressive symptoms for a) all participants in the Cognitive-Behavioral Therapy condition and b) all participants in the Standard Medical Care condition, 4 weeks after the trial ended.
The total score on the HDRS (range = 0 to 84) was used as the outcome measures value, with higher values indicating more severe depressive symptomatology and lower scores representing less severe depressive symptomatology."|14 weeks|||units on a scale||Standard Deviation|Mean
738927|NCT00464464|Primary|Hamilton Depression Rating Scale: Endpoint|"This measure uses the Hamilton Depression Rating Scale (HDRS) to express the average severity of depressive symptoms for a) all participants in the Cognitive-Behavioral Therapy condition and b) all participants in the Standard Medical Care condition, at the end of the 10 week trial.
The total score on the HDRS (range = 0 to 84) was used as the outcome measures value, with higher values indicating more severe depressive symptomatology and lower scores representing less severe depressive symptomatology."|10 weeks|||units on a scale||Standard Deviation|Mean
738928|NCT00464464|Primary|Hamilton Depression Rating Scale: Midpoint|"This measure uses the Hamilton Depression Rating Scale (HDRS) to express the average severity of depressive symptoms for a) all participants in the Cognitive-Behavioral Therapy condition and b) all participants in the Standard Medical Care condition, after 5 weeks of the trial.
The total score on the HDRS (range = 0 to 84) was used as the outcome measures value, with higher values indicating more severe depressive symptomatology and lower scores representing less severe depressive symptomatology."|5 weeks|||units on a scale||Standard Deviation|Mean
738929|NCT00464464|Primary|Hamilton Depression Rating Scale: Baseline|"This measure uses the Hamilton Depression Rating Scale (HDRS) to express the average severity of depressive symptoms for a) all participants in the Cognitive-Behavioral Therapy condition and b) all participants in the Standard Medical Care condition, at the outset of the trial.
The total score on the HDRS (range = 0 to 84) was used as the outcome measures value, with higher values indicating more severe depressive symptomatology and lower scores representing less severe depressive symptomatology."|0 weeks|||units on a scale||Standard Deviation|Mean
738930|NCT00464490|Primary|Mechanical Ventilation Time||time from first weaning attempt to successful extubation|||hours||Standard Deviation|Mean
738931|NCT00464542|Secondary|Median Time to Bacterial Vaginosis During the 30 Days After Cessation of Metronidazole Therapy|The time by which half of the participants were diagnosed with bacterial vaginosis, defined as any vaginal smear with a Nugent score of 7-10 during the 30 day period following cessation of metronidazole therapy|30 days after cessation of metronidazole therapy|||Days||Full Range|Median
738932|NCT00464542|Primary|Number of Participants With Bacterial Vaginosis Recurrence|Bacterial vaginosis, defined as any vaginal smear with a Nugent score of 7-10 during the 30 day period following cessation of metronidazole therapy.|30 days after cessation of metronidazole therapy|per protocol||Participants|||Number
740208|NCT00462722|Secondary|Change in Thigh Cross-sectional Muscle Area||Baseline and after 9 months of training|Because of the costs associated with data analysis for this secondary outcome, we did not pursue the analysis after learning the results of the primary outcome (fat-free mass).|||||
738949|NCT00464646|Secondary|Percentage of Surgical Complications (From Mastectomy, Lumpectomy, and Axillary Staging Procedures) (Cohort A)||2-4 weeks after surgery and at 9 and 12 months from study entry||||||
738950|NCT00464646|Secondary|Overall Survival||From the first dose of study therapy until the date of death or for a maximum of five (5) years from study entry||||||
738951|NCT00464646|Secondary|Recurrence-free Survival||From the first dose of study therapy until the date of recurrence or for a maximum of five (5) years from study entry||||||
738952|NCT00464646|Secondary|Grade 3 and 4 Toxicities, Including Toxicities Associated With Radiation Therapy(RT)||Before each cycle of pre-op Rx; 2-4 wks after the last docetaxel dose; 2-4 wks post surgery (Cohort A); every 6 wks during post-op Rx (Cohort A); every 6 wks during targeted therapy alone (Cohort B); RT complications assessed at 12 mos from study entry||||||
738953|NCT00464646|Secondary|Clinical Complete Response (cCR)||Determined at baseline, between EC and docetaxel, and following docetaxel (before surgery)||||||
738954|NCT00464646|Secondary|pCR in the Breast (Cohort A)||Assessed at the time of surgery||||||
738955|NCT00464646|Primary|Cardiac Event Rate as Determined by LVEF Assessment||Cohort A: Baseline, post-treatment with EC, 2-4 weeks after surgery, and 9, 12, 15, and 18 months from study entry. Cohort B: Baseline, post-treatment with EC, 2-3 weeks after the last dose of docetaxel, and 6, 9, 12, 15, and 18 months from study entry.||||||
738956|NCT00464646|Primary|Number of Patients With Pathological Complete Response (pCR) in the Breast and Nodes for Patients With HER2-positive LABC Following Neoadjuvant Treatment (Cohort A)|The determination of pCR is performed by the local pathologist following examination of tissue (breast and nodes)removed at the time of surgery. The outcome measure is the number of participants with no histologic evidence of invasive tumor cells in the surgical breast specimen, axillary nodes, or SNs identified after neoadjuvant chemotherapy.|Assessed at time of surgery on average at 8 months|73 of the 76 patients in Cohort A were analyzed: 2 patients did not have surgery and 1 patient did not have the nodal status determined.||participants|||Number
738957|NCT00464672|Secondary|Geometric Mean Titers (GMTs), in Healthy Adults 18 to 64 Years of Age|Immunogenicity measured by GMTs after one injection of the investigational influenza virus vaccine, in healthy adults 18 to 64 years of age.|21 days after vaccination|The analysis was done on the per protocol population||Titers||95% Confidence Interval|Geometric Mean
738958|NCT00464672|Secondary|Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.|Solicited local and systemic reactions were assessed after each vaccination, in healthy children 3 to 8 years of age.|7 days after each vaccination|The analysis was performed on the safety population.||Participants|||Number
738959|NCT00464672|Secondary|Geometric Mean Titers (GMTs), in Healthy Children 3 to 8 Years of Age|To evaluate immunogenicity measured by GMTs after two injections of the investigational influenza virus vaccine, in healthy children 3 to 8 years of age.|50 days after last vaccination|The analysis was performed on the per-protocol (PP)population.||Titers||95% Confidence Interval|Geometric Mean
738960|NCT00464672|Secondary|Percentage of Subjects Achieving Seroconversion Rate, in Healthy Children 3 to 8 Years of Age|Seroconversion rate is defined as percentage of subjects achieving seroconversion (defined as negative pre-vaccination serum [HI<10]/ post-vaccination HI titer ≥40) or significant increase (defined as at least a 4-fold increase) after two injections of the investigational influenza virus vaccine, in healthy children 3 to 8 years of age.|50 days after last vaccination|The analysis was performed on the per protocol (PP) population.||Percentage of participants||95% Confidence Interval|Mean
738961|NCT00464672|Secondary|Percentage of Subjects With Seroprotection, in Healthy Children 3 to 8 Years of Age|To descriptively evaluate immunogenicity, measured by seroprotection rate (percentage of subjects achieving a hemagglutination inhibition [HI] titer ≥40) after two injections of the investigational influenza virus vaccine, in healthy children 3 to 8 years of age.|50 days after last vaccination|The analysis was performed on the per-protocol (PP) population||Percentage of participants||95% Confidence Interval|Mean
738962|NCT00464672|Secondary|Number of Subjects Reporting Solicited Local and Systemic Symptoms in Children/Adolescents 9 to 17 Years of Age|Solicited local and systemic reactions were assessed after vaccination in children/adolescents 9 to 17 years of age.|7 days after vaccination|The analysis was performed on the safety population.||Participants|||Number
738963|NCT00464672|Secondary|Geometric Mean Titers (GMTs), in Healthy Children/Adolescents 9 to 17 Years of Age|To evaluate immunogenicity measured by GMTs after one injection of investigational influenza virus vaccine, administered to healthy children/adolescents 9 to 17 years of age.|21 days after vaccination|The analysis was performed on the per-protocol (PP)population||Titers||95% Confidence Interval|Geometric Mean
738964|NCT00464672|Secondary|Percentage of Subjects Achieving Seroconversion Rate, in Healthy Children/Adolescents 9 to 17 Years of Age|Seroconversion rate is defined as percentage of subjects achieving seroconversion (defined as negative pre-vaccination serum [HI<10]/ post-vaccination HI titer ≥40) or significant increase (defined as at least a 4-fold increase) after one injection of the investigational influenza virus vaccine, administered to healthy children/adolescents 9 to 17 years of age.|21 days after vaccination|The analysis was performed on the per-protocol (PP)population.||Percentage of participants||95% Confidence Interval|Mean
738965|NCT00464672|Secondary|Percentage of Subjects With Seroprotection, in Healthy Children/Adolescents 9 to 17 Years of Age|To descriptively evaluate immunogenicity, measured by seroprotection rate (percentage of subjects achieving a hemagglutination inhibition [HI] titer ≥40) after one injection of investigational influenza virus vaccine, administered to healthy children/adolescents 9 to 17 years of age.|21 days after vaccination|The analysis was performed on the per-protocol (PP) population.||Percentage of subjects||95% Confidence Interval|Mean
738966|NCT00464672|Secondary|Number of Subjects Reporting Solicited Local and Systemic Symptoms in Adults 18 to 64 Years of Age|Solicited local and systemic reactions were assessed after vaccination in adults 18 to 64 years of age.|7 days after vaccination|The analysis was performed on the safety population.||participants|||Number
738967|NCT00464672|Primary|Percentage of Subjects Achieving a Seroconversion Rate, in Adults 18 to 64 Years of Age|Seroconversion rate is defined as percentage of subjects achieving seroconversion (defined as negative pre-vaccination serum [HI<10]/ post-vaccination HI titer ≥40) or significant increase defined as at least a 4-fold increase). According to the CBER Guidance, the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconverion/significant increase meet or exceed 40%.|21 days after vaccination|The analysis was performed on the per-protocol (PP) population.||Percentage of participants||95% Confidence Interval|Mean
739008|NCT00465088|Secondary|Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 12|(Week 12 LDL-C minus baseline LDL-C) x 100/baseline LDL-C|From baseline to Week 12|All treated subjects whose Week 12 value was obtained within the Week 12 visit window (between 70 days after first dose and not more than 3 days after last dose)||percent change||95% Confidence Interval|Least Squares Mean
738968|NCT00464672|Primary|Percentage of Subjects With Seroprotection, in Healthy Adults 18 to 64 Years of Age|To evaluate immunogenicity, measured by seroprotection (percentage of subjects achieving a hemagglutination inhibition [HI] titer ≥40) after one injection of the investigational influenza virus vaccine, administered to healthy adults 18 to 64 years of age. The CBER Guidance states that the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroprotection meet or exceed 70%.|21 days after vaccination|The analysis was performed on the per-protocol (PP) population.||Percentages of participants||95% Confidence Interval|Mean
738969|NCT00464685|Secondary|Time to Retreatment in the Study Eye|Time to retreatment in the study eye is defined as the number of days between the initial treatment and re-treatment with the study medication.|12 Months|Intent to Treat: all randomized patients||Days||95% Confidence Interval|Median
738970|NCT00464685|Secondary|Change From Baseline in the Focal Leakage Area in the Study Eye|Focal leakage area in the study eye is assessed using fluorescein angiography. A positive number change from baseline indicates a worsening and a negative number change from baseline indicates an improvement.|Baseline, Month 12|Intent to Treat: all randomized patients||Millimeters Squared (mm^2)||Standard Deviation|Mean
738971|NCT00464685|Secondary|Change From Baseline in Central Subfield Retinal Thickness in the Study Eye|Central subfield retinal thickness is assessed in the study eye by Optical Coherence Tomography (OCT). The central subfield is an area in the retina (back of the eye). OCT is a laser-based, noninvasive, diagnostic system that provides high-resolution, three-dimensional images of the retina from which retinal thickness can be measured. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.|Baseline, Month 12|Intent to Treat: all randomized patients||Microns||Standard Deviation|Mean
738972|NCT00464685|Secondary|Change From Baseline in BCVA in the Study Eye|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.|Baseline, Month 12|Intent to Treat: all randomized patients||Letters Read Correctly||Standard Deviation|Mean
738973|NCT00464685|Primary|Percentage of Patients With at Least 10 Letters of Improvement in Best Corrected Visual Acuity (BCVA) From Baseline in the Study Eye|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.|Baseline, Month 12|Intent to Treat: all randomized patients||Percentage of Patients|||Number
738974|NCT00464698|Secondary|Clinical Global Impressions Scale at Week 3 and Week 17|"Global severity of illness, such that a higher score reflects worse global severity
Minimum score: 2 Maximum score: 14"|Week 3 to 17|20 participants with OCD were enrolled in a 17-week, open label treatment trial with duloxetine.||units on a self-report questionnaire||Standard Deviation|Mean
738975|NCT00464698|Secondary|QLESQ (Quality of Life, Enjoyment, and Satisfaction Questionnaire) - First and Last Visit (Week 0 and Week 17)|"Quality of life, such that lower score reflects poorer quality of life
Minimum score: 16 Maximum score: 80"|Week 0 to 17|20 participants with OCD were enrolled in a 17-week, open label treatment trial with duloxetine.||units on a self-report questionnaire||Standard Deviation|Mean
738976|NCT00464698|Secondary|BAI (Beck Anxiety Inventory) - First and Last Visit (Week 0 and Week 17)|"Anxiety severity, such that a higher score on the BAI reflects more severe anxiety.
Minimum value: 0 Maximum value: 63"|Week 0 to 17|20 participants with OCD were enrolled in a 17-week, open label treatment trial with duloxetine.||units on a self-report questionnaire||Standard Deviation|Mean
738977|NCT00464698|Secondary|BDI (Beck Depression Inventory) - First and Last Visit (Week 0 and Week 17).|"Depression severity, such that higher scores on the BDI are reflective of more severe depression.
BDI minimum score: 0 MDI maximum score: 63"|Week 0 to 17|20 participants with OCD were enrolled in a 17-week, open label treatment trial with duloxetine.||units on a self-report questionnaire||Standard Deviation|Mean
738978|NCT00464698|Primary|Y-BOCS Scores at 1st and Last Visit|OCD symptom change. This is the intention-to-treat analyses (with all 20 subjects included) rather than just the subjects who completed the treatment.|Week 0 to 17|||units on a scale||Standard Deviation|Mean
738979|NCT00464711|Primary|Response and Remitter Status at Endpoint, Based on Change in Depression Severity Rating Scores|"The primary outcome in this study was based on the Hamilton Rating Scale for Depression, 17 items (HAMD-17). Clinical Response status was defined as > 50 % reduction in HAMD-17 scores from baseline to endpoint. Clinical Remitter status was defined as endpoint HAMD-17 score < 8.
40 patients (21 female) with major depressive disorder (MDD) started the 12 week study treatment with escitalopram, 25 patients (15 female) completed the 12 weeks."|12 weeks|40 patients (21 female) with MDD enrolled in the 12 week study, 25 patients (15 Female) completed. Current analyses are based on completers only.||participants|||Number
738980|NCT00464737|Primary|Change From Baseline in Average Daily Pain Score to the Last 2 Weeks of the 12-week Treatment Phase (Based on the Per Protocol Set)|The average daily pain score is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst pain ever experienced).|Baseline, Last 2 weeks of the 12-week Treatment Phase|Of the 82 (Placebo), 74 (Rotigotine 4 mg), and 74 (Rotigotine 8 mg) patients randomized, 50, 33 and 22 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Per Protocol Set.||score on a scale||Standard Deviation|Mean
738981|NCT00464737|Secondary|Number of Subjects With Presence of Impulse Control Disorders|Impulse control disorders (ICDs) are a set of psychiatric disorders in which a person is unable to control strong and often harmful impulses. They are assessed in this study using the Jay Modified Minnesota Impulsive Disorders Interview (Jay Modified MIDI), which focuses on the five most common ICDs that may be associated with dopamine agonist use: compulsive buying, compulsive gambling, compulsive eating, hypersexuality and punding (performing repetitive and/or mechanical tasks).|12-week Treatment Phase|Based on the observed outcome for the primary efficacy variable for this study, an abbreviated clinical study report was produced. Summaries were not produced for all pre-planned outcome measures and thus these results are not available. This summary was not produced for the abbreviated clinical study report.|||||
738982|NCT00464737|Secondary|Change From Baseline in Beck Depression Inventory-II (BDI-II) Scores to the Last Assessment in the 12-week Treatment Phase|The Beck Depression Inventory-II is a 21-item questionnaire. Each item is scored on a scale of 0 to 3 with a total score ranging from 0 to 63. A higher total score is associated with more severe depressive symptoms.|Baseline, Last assessment in the 12-week Treatment Phase|Based on the observed outcome for the primary efficacy variable for this study, an abbreviated clinical study report was produced. Summaries were not produced for all pre-planned outcome measures and thus these results are not available. This summary was not produced for the abbreviated clinical study report.|||||
738983|NCT00464737|Secondary|Change From Baseline in Fibromyalgia Symptom Scores to the Last Assessment in the 12-week Treatment Phase|All scores range from 0 to 10 with higher scores corresponding to a greater level of symptom severity.|Baseline, Last assessment in the 12-week Treatment Phase|Based on the observed outcome for the primary efficacy variable for this study, an abbreviated clinical study report was produced. Summaries were not produced for all pre-planned outcome measures and thus these results are not available. This summary was not produced for the abbreviated clinical study report.|||||
738984|NCT00464737|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Scores to the Last Assessment in the 12-week Treatment Phase|The Hospital Anxiety and Depression Scale (HADS) is a self-administered instrument for detecting anxiety and depression in medical outpatients. Scores range from 0 to 21 for each subscale with higher scores reflecting a greater level of anxiety or depression.|Baseline, Last assessment in the 12-week Treatment Phase|Based on the observed outcome for the primary efficacy variable for this study, an abbreviated clinical study report was produced. Summaries were not produced for all pre-planned outcome measures and thus these results are not available. This summary was not produced for the abbreviated clinical study report.|||||
738985|NCT00464737|Secondary|Rotigotine Plasma Concentration at the End of the Maintenance Phase/Week 12||End of the Maintenance Phase/Week 12|The number of patients in the Placebo group has been presented as 0 as this outcome measure is not applicable for this treatment group. Of the 73 (Rotigotine 4 mg) and 74 (Rotigotine 8 mg) patients respectively in the Safety Set, a total of 41 and 20 patients respectively at the end of Maintenance Phase/Week 12 have this assessment.||ug/ML||Standard Deviation|Mean
738986|NCT00464737|Secondary|Number of Subjects Using Rescue Medication and Alcohol During the 12-week Treatment Phase|Subjects recorded use of rescue medication for pain in the diary daily in the evening with a Yes/No response. Use of alcohol to treat pain in the past 24 hours was recorded with a Yes/No response.|12-week Treatment Phase|Based on the observed outcome for the primary efficacy variable for this study, an abbreviated clinical study report was produced. Summaries were not produced for all pre-planned outcome measures and thus these results are not available. This summary was not produced for the abbreviated clinical study report.|||||
738987|NCT00464737|Secondary|Change From Baseline in Morning and Evening Pain Scores to the Last 2 Weeks of the 12-week Treatment Phase|An 11-point Likert scale was used for subjects to assess pain, from 0 (no pain) to 10 (worst pain ever experienced).|Baseline, Last 2 weeks of the 12-week Treatment Phase|Of the 82 (Placebo), 74 (Rotigotine 4 mg), and 74 (Rotigotine 8 mg) patients randomized, 81, 70 and 72 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Full Analysis Set.||Score on a scale||Standard Deviation|Mean
738988|NCT00464737|Secondary|Patient Global Impression of Change (PGIC) Assessment From Baseline to the Last Assessment in the 12-week Treatment Phase|The PGIC is a 7-point self-administered categorical rating scale in which the subject rated the change in pain since starting trial medication (from much worse [score of 1] to much better [score of 7]).|Baseline, Last assessment in the 12-week Treatment Phase|Of the 82 (Placebo), 74 (Rotigotine 4 mg), and 74 (Rotigotine 8 mg) patients randomized, 76, 58, and 51 patients respectively are included in this summary based on the Full Analysis Set and have the Last Assessment in the 12-week Treatment Phase.||Patients|||Number
738989|NCT00464737|Secondary|Change From Baseline in Daily Interference With General Activity to the Last 2 Weeks of the 12-week Treatment Phase|General activity scale - the subject rated how the pain had interfered with general activity, from 0 (did not interfere) to 10 (completely interfered)|Baseline, Last 2 weeks of the 12-week Treatment Phase|Of the 82 (Placebo), 74 (Rotigotine 4 mg), and 74 (Rotigotine 8 mg) patients randomized, 81, 70 and 72 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Full Analysis Set.||Score on a scale||Standard Deviation|Mean
738990|NCT00464737|Secondary|Change From Baseline in Average Daily Interference With Sleep to the Last 2 Weeks of the 12-week Treatment Phase|Sleep scale - the subject rated quality of sleep, from 0 (very good sleep) to 10 (very poor sleep)|Baseline, Last 2 weeks of the 12-week Treatment Phase|Of the 82 (Placebo), 74 (Rotigotine 4 mg), and 74 (Rotigotine 8 mg) patients randomized, 81, 70 and 72 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Full Analysis Set.||Score on a scale||Standard Deviation|Mean
738991|NCT00464737|Secondary|Change From Baseline in Total Myalgic Score to the Last Assessment in the 12-week Treatment Phase|Total Myalgic Score ranges from 0 to 54 with higher scores corresponding to a greater level of pain.|Baseline, Last assessment in the 12-week Treatment Phase|Based on the observed outcome for the primary efficacy variable for this study, an abbreviated clinical study report was produced. Summaries were not produced for all pre-planned outcome measures and thus these results are not available. This summary was not produced for the abbreviated clinical study report.|||||
738992|NCT00464737|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score to the Last Assessment in the 12-week Treatment Phase|The Fibromyalgia Impact Questionnaire (FIQ) Total Score ranges from 0 to 100 with higher scores corresponding to a greater impact of fibromyalgia|Baseline, Last assessment in the 12-week Treatment Phase|Of the 82 (Placebo), 74 (Rotigotine 4 mg), and 74 (Rotigotine 8 mg) patients randomized, 80, 64 and 63 patients respectively are included in this summary based on the Full Analysis Set and have the Last Assessment in the 12-week Treatment Phase.||Score on a scale||Standard Deviation|Mean
738993|NCT00464737|Primary|Change From Baseline in Average Daily Pain Score to the Last 2 Weeks of the 12-week Treatment Phase (Based on the Full Analysis Set)|The average daily pain score is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst pain ever experienced).|Baseline, Last 2 weeks of the 12-week Treatment Phase|Of the 82 (Placebo), 74 (Rotigotine 4 mg), and 74 (Rotigotine 8 mg) patients randomized, 81, 70 and 72 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Full Analysis Set.||Score on a scale||Standard Deviation|Mean
738994|NCT00464945|Primary|Geometric Mean Antibody Concentration in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series|Antibody concentration/geometric mean concentration (GMC) as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after 3-dose infant series (5 months of age)|Evaluable immunogenicity (per protocol) population were participants who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.||μg/mL||95% Confidence Interval|Geometric Mean
738995|NCT00464945|Primary|Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series)|Systemic events (fever ≥ 38 degrees Celsius [C] but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C), decreased appetite, irritability, increased sleep, decreased sleep, use of medication to prevent symptoms, and use of medication to treat symptoms) were collected using an electronic diary. Participants may be represented in more than 1 category.|During the 4-day period after toddler dose|The safety population included all participants who received at least 1 dose of vaccine; (n) = number of participants reporting yes for at least 1 day or no for all days.||percentage of participants|||Number
738996|NCT00464945|Primary|Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series)|Systemic events (fever ≥ 38 degrees Celsius [C] but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased appetite, irritability, increased sleep, decreased sleep, use of medication (Meds)to prevent symptoms (sx), and use of medication to treat symptoms) were collected using an electronic diary. Participants may be represented in more than 1 category.|During the 4-day period after each dose|The safety population included all participants (268) who received at least 1 dose of vaccine; (n) = number of participants reporting yes for at least 1 day or no for all days.||percentage of participants|||Number
738997|NCT00464945|Primary|Percentage of Participants Reporting Pre-Specified Local Reactions|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant(Sig) (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (Mod) (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|During the 4-day period after each dose|The safety population included all participants who received at least 1 dose of vaccine; (n) = number of participants reporting yes for at least 1 day or no for all days.||percentage of participants|||Number
738998|NCT00464945|Primary|Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series|Percentages of participants achieving WHO predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after 3-dose infant series (5 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations.||percentage of participants||95% Confidence Interval|Number
738999|NCT00465088|Secondary|Percentage of Subjects With HDL-C >/= 40 mg/dL, LDL-C Meeting NCEP ATP III Goal, and Triglycerides < 150 mg/dL at Week 12|NCEP ATP III goals for LDL-C are as follows: For high-risk patients, LDL-C < 100 mg/dL; for moderate risk patients, LDL-C < 130 mg/dL; for low-risk patients: LDL-C < 160 mg/dL. High-risk means coronary heart disease or risk equivalents; moderate risk means having at least 2 risk factors; low-risk means having no or 1 risk factor.|12 weeks|All treated subjects not meeting NCEP ATP III goals at baseline with both a baseline and at least 1 postbaseline value for all 3 lipid parameters||Percentage of subjects|||Number
739000|NCT00465088|Secondary|Percentage of Subjects With Triglycerides < 150 mg/dL at Week 12||12 weeks|All treated subjects not meeting NCEP ATP III goals at baseline with both a baseline and at least 1 postbaseline triglyceride value||Percentage of subjects|||Number
739001|NCT00465088|Secondary|Percentage of Subjects Meeting National Cholesterol Education Program Adult Treatment Panel (NCEP ATP) III Goal for LDL-C at Week 12|For high-risk patients (coronary heart disease or equivalent), LDL-C < 100 mg/dL and non-HDL-C < 130 mg/dL; for moderate risk patients (having 2 risk factors), LDL-C < 130 mg/dL and non-HDL-C < 160 mg/dL; for low-risk patients (having 0 or 1 risk factor): LDL-C < 160 mg/dL and non-HDL-C < 190 mg/dL.|12 weeks|All treated subjects not meeting NCEP ATP III goals at baseline with both a baseline and at least 1 postbaseline LDL-C value||Percentage of subjects|||Number
739002|NCT00465088|Secondary|Percentage of Subjects Meeting With HDL-C >/= 40 mg/dL at Week 12||12 weeks|All treated subjects not meeting National Cholesterol Education Program Adult Treatment Panel (NCEP ATP) III goals at baseline with both a baseline and at least 1 postbaseline HDL-C value||Percentage of subjects|||Number
739003|NCT00465088|Secondary|Percent Change in Lipoprotein A From Baseline to Week 12|(Week 12 lipoprotein A minus baseline lipoprotein A) x 100/baseline lipoprotein A|From baseline to Week 12|All treated subjects whose Week 12 value was obtained within the Week 12 visit window||percent change||Inter-Quartile Range|Median
739004|NCT00465088|Secondary|Percent Change in Total Cholesterol:HDL-C Ratio|(Week 12 total cholesterol:HDL-C ratio minus baseline total cholesterol:HDL-C ratio) x 100/baseline total cholesterol:HDL-C ratio|From baseline to Week 12|All treated subjects whose Week 12 values were obtained within the Week 12 visit window||percent change||95% Confidence Interval|Least Squares Mean
739005|NCT00465088|Secondary|Percent Change in Total Cholesterol From Baseline to Week 12|(Week 12 total cholesterol minus baseline total cholesterol) x 100/baseline total cholesterol|From baseline to Week 12|All treated subjects whose Week 12 value was obtained within the Week 12 visit window||percent change||95% Confidence Interval|Least Squares Mean
739006|NCT00465088|Secondary|Percent Change in LDL-C:HDL-C Ratio|(Week 12 LDL-C:HDL-C ratio minus baseline LDL-C:HDL-C ratio) x 100/baseline LDL-C:HDL-C ratio|From baseline to Week 12|All treated subjects whose Week 12 values were obtained within the Week 12 visit window||percent change||95% Confidence Interval|Least Squares Mean
739007|NCT00465088|Secondary|Percent Change in Triglycerides From Baseline to Week 12|(Week 12 triglycerides minus baseline triglycerides) x 100/baseline triglycerides|From baseline to Week 12|All treated subjects whose Week 12 value was obtained within the Week 12 visit window||percent change||Inter-Quartile Range|Median
739012|NCT00465088|Primary|Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 12|(Week 12 HDL-C minus baseline HDL-C) x 100/baseline HDL-C|From baseline to Week 12|All treated subjects whose Week 12 value was obtained within the Week 12 visit window||percent change||95% Confidence Interval|Least Squares Mean
739013|NCT00465101|Secondary|Occurrence of Retrograde Ejaculation|Kaplan-Meier estimate of percentage of participants who experience retrograde ejaculation.|5 Year Follow Up|Participants who received the study treatment||percentage of subjects with RE||95% Confidence Interval|Number
739014|NCT00465101|Other Pre-specified|Total Joules Used|Total energy applied during the study procedure|Procedure|Participants who received the study treatment and for whom the outcome measure is available.||kilojoules (kJ)||Standard Deviation|Mean
739015|NCT00465101|Other Pre-specified|Number of Fibers Used During Procedure||Procedure|Participants who received the study treatment and for whom the outcome is available.||number of fibers used||Standard Deviation|Mean
739016|NCT00465101|Other Pre-specified|Length of Lasing (LOL)|Total time the laser was on during the study procedure.|Procedure|Participants who received the study treatment and for whom the outcome measure is available.||minutes||Standard Deviation|Mean
739017|NCT00465101|Other Pre-specified|Length of Procedure (LOP)|Defined as the time from cystoscope insertion into the urethra to the time of cystoscope removal (in minutes).|Procedure|Participants who received the study treatment and for whom the outcome measure is available.||minutes||Standard Deviation|Mean
739018|NCT00465101|Other Pre-specified|Length of Catheterization (LOC)|Defined as the time the subject required an indwelling Foley catheter post treatment (in hours).|Recovery Period|Participants who received the study treatment and for whom the outcome measure is available.||hours||Standard Deviation|Mean
739019|NCT00465101|Other Pre-specified|Length of Hospital Stay (LOS)|Defined as the time from admission to the healthcare facility until discharge (in hours).|Peri-Operative Period|Participants who received the study treatment and for whom the outcome measure is available.||hours||Standard Deviation|Mean
739020|NCT00465101|Secondary|Length of Time to Return to Pre-treatment Level of Physical Activity (in Days), Excluding Sexual Activity.||Up to five years|Participants who received the study treatment and for whom the outcome measure is available.||days||Standard Deviation|Mean
739021|NCT00465101|Secondary|Percentage of Participants With Treatment Success|Treatment success is determined on a per patient basis and is defined as a 50% or greater decrease in IPSS from baseline to the specified time point.|5 Years|Participants who received the study treatment and for whom the outcome measure is available.||Percent of subjects w/ treatment success||95% Confidence Interval|Number
739022|NCT00465101|Secondary|Gross Hematuria|Kaplan-Meier estimate of percentage of participants who require a blood transfusion as a result of hematuria.|91 days|Participants who received the study treatment||Percentage of subjects|||Number
739023|NCT00465101|Secondary|Quality of Life Score (QoL) From I-PSS From Baseline Through 5 Years.|"Participant response to the question If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?. Values range from 0 (Delighted) to 6 (Terrible) with higher values indicating worse outcomes."|5 years|Participants who received the study treatment and for whom the outcome measure is available.||Score on a scale||Standard Deviation|Mean
739024|NCT00465101|Secondary|Percentage of Participants With Clinically-significant Improvement in Post-void Residual Urine Volume.|A clinically significant improvement in post-void residual is defined as a decrease of at least 50ml from baseline to 6 months.|6 months post-treatment|Participants who received the study treatment and for whom the outcome measure is available.||percentage of patients improved||95% Confidence Interval|Number
739025|NCT00465101|Secondary|Percentage of Participants With Clinically-significant Improvement in Uroflow.|A clinically significant improvement in uroflow is defined as an increase in peak urinary flow rate (Qmax) of at least five ml/sec from baseline to 6 months|6 months post-treatment|Participants who received the study treatment and for whom the outcome measure is available.||percentage of patients improved||95% Confidence Interval|Number
739026|NCT00465101|Secondary|Treatment-related Complication|"Treatment-related events include the following:
Infection that requires IV antibiotics or re-hospitalization or prolongation of existing hospitalization
Perforation / injury of adjacent organ(s)
Bladder neck contracture(s) requiring re-catheterization after post-surgery catheter removal
Hematuria requiring transfusion
Urinary retention requiring corrective intervention
De novo erectile dysfuction (ED)
Transfusion secondary to procedure-related anemia
Post procedure incontinence secondary to damage to the external urinary sphincter
Any other treatment-related injury requiring intervention"|3 months|Participants who received the study treatment.||percentage of subjects with complication||95% Confidence Interval|Number
739027|NCT00465101|Primary|Percentage of Participants With Treatment Success|Treatment success is determined on a per patient basis and is defined as [(baseline I-PSS - I-PSS at 6-months)/ baseline I-PSS] greater than or equal to 50%|6 months|Participants who received the study treatment and for whom the outcome measure is available.||percentage of participants|||Number
739028|NCT00465179|Secondary|Median Overall Survival|Overall survival was estimated using the Kaplan-Meier method.|Baseline till participant death or end of follow-up period, assessed every 6 weeks for the first two cycles, then every 12 weeks, up to 5 years.|||months||95% Confidence Interval|Median
739029|NCT00465179|Primary|Median Progression-Free Survival (PFS)|Median Progression-Free Survival was calculated as the time from the date of the first treatment to the date of disease progression or date of death, or the last date of the outcome evaluation, whichever came first.|Every 6 weeks for the first two cycles, then every 12 weeks, up to 2 years|Two participants were not evaluable as one was taken off study due to adverse event and the other due to withdrawal of consent.||months||95% Confidence Interval|Median
739042|NCT00465738|Secondary|Response Rates in Activity of Daily Living (Barthel Index) at Follow up - Item Dressing|Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.|follow up visit, between week 12 and week 20|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
739030|NCT00465179|Primary|Number of Participants With Response to Treatment|Response was assessed using Response Evaluation Criteria In Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least 30% decrease in sum of the longest dimensions (LD) of all target lesions, taking as reference the baseline sum of LD. Stable Disease (SD): Insufficient shrinkage to qualify for partial response, or insufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started. Progressive Disease (PD): At least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Every 6 weeks for the first two cycles, then every 12 weeks, up to 2 years|Two participants were not evaluable as one was taken off study due to adverse event and the other due to withdrawal of consent.||participants|||Number
739031|NCT00465361|Primary|Presence of Resident Surveillance Behaviors of Specific Aspects of Developmental Status at the Two Month Preventive Care Visit|Residents were observed to determine whether specific aspects of infant developmental status, as part of developmental surveillance, were assessed during the two-month preventive care visit. The components of developmental surveillance observed were: assessment of the infant's ability to follow past midline, assessment of the infant's ability to lift his/her head off of the table in prone, assessment of the infant's ability to hold an object placed in his/her hand, assessment of the infant's ability to coo, and assessment of the infant's ability to demonstrate a social smile.|Residents were observed during each of the eligible preventive care visits. Each visit was an average of 20 minutes in length. Preventive care visits were observed over a 13 month time period.|||Participants|||Number
739032|NCT00465530|Primary|Change in Overall Quality of Life|Measured by Quality of Life Survey (SN-5). Scores ranged from 0 - 7. The higher the numerical score, the worse the problem.|3 Weeks to Follow-Up (7 Weeks)|||units on a scale||Standard Deviation|Mean
739033|NCT00465530|Secondary|Change in Overall Quality of Life|Measured by Quality of Life Survey (SN-5). Scores ranged from 0 - 7. The higher the numerical score, the worse the problem.|Baseline to 3 Weeks|||units on a scale||Standard Deviation|Mean
739034|NCT00465530|Primary|Change in Computed Tomography (CT) Score After Treatment|Change in CT score reflects the Lund-Mackay staging system. Each sinus is scored separately and scores are determined for the right and the left side. The lowest score of 0 represents no opacification in the sinus. A score of 1 represents a partial opacification. A score of 2 represents complete opacification.|Change from Baseline to 6 Weeks|||units on a scale||Standard Deviation|Mean
739035|NCT00465569|Secondary|Changes in Cow Milk Immunoglobulin G4 (IgG4)|IgG4 is measured in ug/mL. Measurements were obtained at Baseline and at 23 weeks|Baseline and 23 weeks|One participant in the active treatment arm did not complete the study due to persistent eczema during dose escalation||percentage of change||Full Range|Median
739036|NCT00465569|Secondary|Changes in Cow Milk-IgE|IgE is measured in kilounits per liter (kU/L). Measurements were obtained at Baseline and at 23 weeks|Baseline and 23 weeks|One participant in the active treatment arm did not complete the study due to persistent eczema during dose escalation||percentage of change||Full Range|Median
739037|NCT00465569|Primary|The Median Milk Threshold Dose Inducing a Reaction||Baseline and 23 weeks|One participant in the active treatment arm did not complete the study due to persistent eczema during dose escalation. The median milk threshold dose in both groups was 40 with a full range of 40-1340 at the baseline challenge.||miligrams||Full Range|Median
739074|NCT00465738|Secondary|Responder in Ashworth Scale (Wrist Flexors) at Week 4 - Full Analysis Set|Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.|week 4|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
739043|NCT00465738|Secondary|Response Rates in Activity of Daily Living (Barthel Index) at Week 12 - Item Dressing|Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.|week 12|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
739044|NCT00465738|Secondary|Response Rates in Activity of Daily Living (Barthel Index) at Week 4 - Item Dressing|Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.|week 4|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
739045|NCT00465738|Secondary|Response Rates in Activity of Daily Living (Barthel Index) at Follow up - Item Bathing/Showering|Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.|follow up visit, between week 12 and week 20|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
739046|NCT00465738|Secondary|Response Rates in Activity of Daily Living (Barthel Index) at Week 12 - Item Bathing/Showering|Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.|week 12|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
739047|NCT00465738|Secondary|Response Rates in Activity of Daily Living (Barthel Index) at Week 4 - Item Bathing/Showering|Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.|week 4|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
739048|NCT00465738|Secondary|Response Rates in Activity of Daily Living (Barthel Index) at Follow up - Item Toilet Use|Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.|follow up visit, between week 12 and week 20|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
739049|NCT00465738|Secondary|Response Rates in Activity of Daily Living (Barthel Index) at Week 12 - Item Toilet Use|Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.|week 12|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
739050|NCT00465738|Secondary|Response Rates in Activity of Daily Living (Barthel Index) at Week 4 - Item Toilet Use|Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.|week 4|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
739075|NCT00465738|Secondary|Responder in Ashworth Scale (Elbow Flexors) at Follow up - Full Analysis Set|Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.|follow up visit, between week 12 and week 20|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
739051|NCT00465738|Secondary|Response Rates in Activity of Daily Living (Barthel Index) at Follow up - Item Grooming|Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.|follow up visit, between week 12 and week 20|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
739052|NCT00465738|Secondary|Response Rates in Activity of Daily Living (Barthel Index) at Week 12 - Item Grooming|Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.|week 12|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
739053|NCT00465738|Secondary|Response Rates in Activity of Daily Living (Barthel Index) at Week 4 - Item Grooming|Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.|week 4|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
739054|NCT00465738|Secondary|Response Rates in Activity of Daily Living (Barthel Index) at Follow up - Item Feeding|Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.|follow up visit, between week 12 and week 20|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
739055|NCT00465738|Secondary|Response Rates in Activity of Daily Living (Barthel Index) at Week 12 - Item Feeding|Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.|week 12|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
739056|NCT00465738|Secondary|Response Rates in Activity of Daily Living (Barthel Index) at Week 4 - Item Feeding|Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.|week 4|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
739057|NCT00465738|Secondary|Patient's Global Assessment of Treatment Response (GATR) - Full Analysis Set|The patient’s global assessment of response to treatment were determined with the use of the Global Response Scale using the following scores: -4 = very marked worsening; -3 = marked worsening; -2 = moderate worsening; -1 = mild worsening; 0 = no change; +1 = mild improvement; +2 = moderate improvement; +3 = marked improvement; +4 = very marked improvement.|week 4|Full Analysis Set||units on a scale||Standard Error|Mean
739058|NCT00465738|Secondary|Investigator’s Global Assessment of Treatment Response (GATR) - Full Analysis Set|The investigator’s global assessment of response to treatment were determined with the use of the Global Response Scale using the following scores: -4 = very marked worsening; -3 = marked worsening; -2 = moderate worsening; -1 = mild worsening; 0 = no change; +1 = mild improvement; +2 = moderate improvement; +3 = marked improvement; +4 = very marked improvement.|week 4|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||units on a scale||Standard Error|Mean
739059|NCT00465738|Secondary|Change From Baseline in Passive Range of Motion (PROM) - Elbow Maximum Flexion|For the PROM all motions of wrist and elbow were measured from a defined neutral starting point position. The degrees of motion were added in the direction the wrist and elbow moved from the neutral starting position. The neutral starting position was the position of an upright standing/sitting person. The angle of the motion from the neutral starting position was measured in degrees using a goniometer. Angles were measured for the wrist with maximal dorsal extension, neutral position and maximal palmar flexion, and for the elbow with maximal extension, neutral position and maximal flexion.|baseline, week 4, week 12, follow up (between week 12 and week 20)|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||degree||Standard Error|Mean
739060|NCT00465738|Secondary|Change From Baseline in Passive Range of Motion (PROM) - Wrist Maximum Flexion|For the PROM all motions of wrist and elbow were measured from a defined neutral starting point position. The degrees of motion were added in the direction the wrist and elbow moved from the neutral starting position. The neutral starting position was the position of an upright standing/sitting person. The angle of the motion from the neutral starting position was measured in degrees using a goniometer. Angles were measured for the wrist with maximal dorsal extension, neutral position and maximal palmar flexion, and for the elbow with maximal extension, neutral position and maximal flexion.|baseline, week 4, week 12, follow up (between week 12 and week 20)|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||degree||Standard Error|Mean
739061|NCT00465738|Secondary|Change From Baseline in Passive Range of Motion (PROM) - Elbow Extension|For the PROM all motions of wrist and elbow were measured from a defined neutral starting point position. The degrees of motion were added in the direction the wrist and elbow moved from the neutral starting position. The neutral starting position was the position of an upright standing/sitting person. The angle of the motion from the neutral starting position was measured in degrees using a goniometer. Angles were measured for the wrist with maximal dorsal extension, neutral position and maximal palmar flexion, and for the elbow with maximal extension, neutral position and maximal flexion.|baseline, week 4, week 12, follow up (between week 12 and week 20)|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||degree||Standard Error|Mean
739062|NCT00465738|Secondary|Change From Baseline in Passive Range of Motion (PROM) - Wrist Extension|For the PROM all motions of wrist and elbow were measured from a defined neutral starting point position. The degrees of motion were added in the direction the wrist and elbow moved from the neutral starting position. The neutral starting position was the position of an upright standing/sitting person. The angle of the motion from the neutral starting position was measured in degrees using a goniometer. Angles were measured for the wrist with maximal dorsal extension, neutral position and maximal palmar flexion, and for the elbow with maximal extension, neutral position and maximal flexion.|baseline, week 4, week 12, follow up (between week 12 and week 20)|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||degree||Standard Error|Mean
739063|NCT00465738|Secondary|Responder in Ashworth Scale (Forearm Pronators) at Follow up - Full Analysis Set|Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.|follow up visit, between week 12 and week 20|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
739064|NCT00465738|Secondary|Responder in Ashworth Scale (Forearm Pronators) at Week 12 - Full Analysis Set|Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.|week 12|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
739065|NCT00465738|Secondary|Responder in Ashworth Scale (Forearm Pronators) at Week 4 - Full Analysis Set|Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.|week 4|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
739066|NCT00465738|Secondary|Responder in Ashworth Scale (Fingers Flexors) at Follow up - Full Analysis Set|Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.|follow up visit, between week 12 and week 20|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
739067|NCT00465738|Secondary|Responder in Ashworth Scale (Fingers Flexors) at Week 12 - Full Analysis Set|Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.|week 12|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
739068|NCT00465738|Secondary|Responder in Ashworth Scale (Fingers Flexors) at Week 4 - Full Analysis Set|Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.|week 4|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
739069|NCT00465738|Secondary|Responder in Ashworth Scale (Thumb Flexors) at Follow up - Full Analysis Set|Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.|follow up visit, between week 12 and week 20|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
739070|NCT00465738|Secondary|Responder in Ashworth Scale (Thumb Flexors) at Week 12 - Full Analysis Set|Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.|week 12|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
739071|NCT00465738|Secondary|Responder in Ashworth Scale (Thumb Flexors) at Week 4 - Full Analysis Set|Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.|week 4|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
739072|NCT00465738|Secondary|Responder in Ashworth Scale (Wrist Flexors) at Follow up - Full Analysis Set|Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.|follow up visit, between week 12 and week 20|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
739073|NCT00465738|Secondary|Responder in Ashworth Scale (Wrist Flexors) at Week 12 - Full Analysis Set|Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.|week 12|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
739076|NCT00465738|Secondary|Responder in Ashworth Scale (Elbow Flexors) at Week 12 - Full Analysis Set|Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.|week 12|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
739077|NCT00465738|Secondary|Responder in Ashworth Scale (Elbow Flexors) at Week 4 - Full Analysis Set|Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit. The Ashworth Scale is a 5-point-scale to rate to degree of spasticity: 0 = No increase in tone; 1 = Slight increase in tone giving a “catch” when the limb was moved in flexion or extension; 2 = More marked increase in tone, but limb easily flexed; 3 = Considerable increase in tone - passive movements difficult; 4 = Limb rigid in flexion or extension.|week 4|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
739078|NCT00465738|Secondary|Responder in FAT at Follow up - Full Analysis Set|Response is defined as an improvement (increase) of at least one point in the FAT from baseline visit. For the FAT the investigator assessed the extent of functionality of the upper limb according to five standardized tests. Each test is rated with 0 = failed or 1 = successfully passed. For the evaluation, the sum of all test scores was calculated resulting in a total score from 0 to 5.|follow up visit, between week 12 and week 20|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
739079|NCT00465738|Secondary|Responder in FAT at Week 12 - Full Analysis Set|Response is defined as an improvement (increase) of at least one point in the FAT from baseline visit. For the FAT the investigator assessed the extent of functionality of the upper limb according to five standardized tests. Each test is rated with 0 = failed or 1 = successfully passed. For the evaluation, the sum of all test scores was calculated resulting in a total score from 0 to 5.|Week 12|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
739080|NCT00465738|Secondary|Responder in Frenchay Arm Test (FAT) at Week 4 - Full Analysis Set|Response is defined as an improvement (increase) of at least one point in the FAT from baseline visit. For the FAT the investigator assessed the extent of functionality of the upper limb according to five standardized tests. Each test is rated with 0 = failed or 1 = successfully passed. For the evaluation, the sum of all test scores was calculated resulting in a total score from 0 to 5.|Week 4|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
739081|NCT00465738|Secondary|Responder in DAS at Follow up - Full Analysis Set|Response is defined as an improvement (reduction) of at least one point in the DAS for the primary therapeutic target from baseline visit.|follow up visit, between week 12 and week 20|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
739082|NCT00465738|Secondary|Responder in DAS at Week 12 - Full Analysis Set|Response is defined as an improvement (reduction) of at least one point in the DAS for the primary therapeutic target from baseline visit.|week 12|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
739083|NCT00465738|Secondary|Responder in DAS at Week 4 - Full Analysis Set|Response is defined as an improvement (reduction) of at least one point in the DAS for the primary therapeutic target from baseline visit.|week 4|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
739084|NCT00465738|Primary|Responder in Disability Assessment Scale (DAS) at Week 4 - Per Protocol Set|The primary efficacy endpoint is the number of responder at Week 4; response defined as an improvement (reduction) of at least one point in the DAS for the primary therapeutic target from baseline visit to Week 4. The DAS determines the functional impairment for the domains hygiene, dressing, limb position and pain according to the following scale: 0 = no disability; 1 = mild disability; 2 = moderate disability; 3 = severe disability. At Screening visit, the subject and investigator, selected together one of the four domains as the primary therapeutic target.|At week 4|Analysis is based on Per Protocol Set, defined as all randomized subjects who received at least one dose of study drug and who have no major deviation from study protocol. For this set of subjects no missing values can occur for the primary endpoint.||participants|||Number
739085|NCT00465816|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the entire study (up to Month 7)|The analysis was performed on the Total Vaccinated Cohort including all subjects with study vaccine administered.||Subjects|||Number
739086|NCT00465816|Secondary|Number of Subjects Reporting Any Conditions Prompting Emergency Room Visits||During the entire study (up to Month 7)|The analysis was performed on the Total Vaccinated Cohort including all subjects with study vaccine administered.||Subjects|||Number
739087|NCT00465816|Secondary|Number of Subjects Reporting Any Rash|Rashes include e.g. hives, idiopathic thrombocytopenic purpura, petechiae.|During the entire study (up to Month 7)|The analysis was performed on the Total Vaccinated Cohort including all subjects with study vaccine administered.||Subjects|||Number
739088|NCT00465816|Secondary|Number of Subjects Reporting Any Specific AEs of New Onset of Chronic Illnesses|Specific AEs of new onset of chronic illnesses include e.g. autoimmune disorders, asthma, type I diabetes and allergies.|During the entire study (up to Month 7)|The analysis was performed on the Total Vaccinated Cohort including all subjects with study vaccine administered.||Subjects|||Number
739089|NCT00465816|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Up to 1 month after each vaccine dose|The analysis was performed on the Total Vaccinated Cohort including all subjects with study vaccine administered.||Subjects|||Number
739090|NCT00465816|Secondary|Number of Subjects Reporting Any Solicited General Symptoms|Solicited general symptoms assessed include fatigue, fever (axillary temperature greater than or equal to 37.5 degrees Celcius), gastrointestinal symptoms and headache.|During a 4-day period after any vaccination|The analysis was done on the Total Vaccinated Cohort including all subjects with study vaccine administered and with a completed symptom sheet.||Subjects|||Number
739091|NCT00465816|Secondary|Number of Subjects Reporting Any Solicited Local Symptoms Post-Twinrix Vaccination|Solicited local symptoms assessed include pain, redness and swelling.|During a 4-day period after each Twinrix vaccination|The analysis was done on the Total Vaccinated Cohort including all subjects with study vaccine administered and with a completed symptom sheet. Only subjects from the groups receiving Twinrix were assessed.||Subjects|||Number
739092|NCT00465816|Secondary|Number of Subjects Reporting Any Solicited Local Symptoms Post-meningococcal Vaccination|Solicited local symptoms assessed include pain, redness and swelling.|During a 4-day period after Nimenrix vaccination|The analysis was done on the Total Vaccinated Cohort including all subjects with study vaccine administered and with a completed symptom sheet. Only subjects from the groups receiving Nimenrix were assessed.||Subjects|||Number
739093|NCT00465816|Secondary|Number of Subjects With IgG Anti-HB Antibody Concentrations Above the Pre-defined Cut-off Value|The cut-off value assessed was greater than or equal to 10 milli-Internatinal Units per Milliliter (mIU/mL).|Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7)|The analysis was performed on the According-to-Protocol cohort for immunogenicity including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Twinrix vaccine.||Subjects|||Number
739094|NCT00465816|Secondary|IgG Anti-HBs Antibody Concentrations|Concentrations are given as Geomatric Mean Concentrations expressed as milli-Internatinal Units per Milliliter (mIU/mL).|Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7)|The analysis was performed on the According-to-Protocol cohort for immunogenicity including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Twinrix vaccine.||milli-Internatinal Units per Milliliter||95% Confidence Interval|Geometric Mean
739095|NCT00465816|Secondary|Number of Subjects With IgG Anti-HAV Antibody Concentrations Above the Pre-defined Cut-off Value|The cut-off value assessed was greater than or equal to 15 milli-Internatinal Units per Milliliter (mIU/mL).|Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7)|The analysis was performed on the According-to-Protocol cohort for immunogenicity including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Twinrix vaccine.||Subjects|||Number
739096|NCT00465816|Secondary|Immunoglobulin G (IgG) Anti-HAV Antibody Concentrations|Concentrations are given as Geomatric Mean Concentrations expressed as milli-Internatinal Units per Milliliter (mIU/mL).|Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7)|The analysis was performed on the According-to-Protocol cohort for immunogenicity including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Twinrix vaccine.||milli-Internatinal Units per Milliliter||95% Confidence Interval|Geometric Mean
739097|NCT00465816|Secondary|Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values at Month 7|The cut-off values assessed include greater than or equal to (≥) 0.3 micrograms per milliliter (µg/mL) and ≥ 2.0 µg/mL.|At Month 7|The analysis was performed on the ATP cohort for immunogenicity, only on those groups of subjects that received Nimenrix. A randomized subset of half of the subjects had sera tested for anti-PSA and anti-PSC antibodies by Enzyme-linked Immunosorbent assay (ELISA) while the other half were tested for anti PSW-135 and anti-PSY antibodies by ELISA.||Subjects|||Number
739098|NCT00465816|Secondary|Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations at Month 7|Concentrations were provided as Geometric Mean Concentrations expressed as micrograms per milliliter (µg/mL).|At Month 7|The analysis was performed on the ATP cohort for immunogenicity, only on those groups of subjects that received Nimenrix. A randomized subset of half of the subjects had sera tested for anti-PSA and anti-PSC antibodies by Enzyme-linked Immunosorbent assay (ELISA) while the other half were tested for anti PSW-135 and anti-PSY antibodies by ELISA.||micrograms per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
739099|NCT00465816|Secondary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values at Month 7|The cut-off values assessed were greater than or equal to (≥) 1:8 and ≥ 1:128.|At Month 7|The analysis was performed on the According-to-Protocol cohort for immunogenicity including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Nimenrix vaccine.||Subjects|||Number
739100|NCT00465816|Secondary|rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers at Month 7|The rSBA titers were expressed as geometric mean titers.|At Month 7|The analysis was performed on the According-to-Protocol cohort for immunogenicity including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Nimenrix vaccine.||Titer||95% Confidence Interval|Geometric Mean
739101|NCT00465816|Secondary|Number of Subjects With Anti-tetanus Toxoid Antibody Concentrations Above the Pre-defines Cut-off Value|The cut-off value assessed was greater than or equal to 0.1 International Units per milliliter (IU/mL).|Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)|The analysis was performed on the According-to-Protocol cohort for immunogenicity including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Nimenrix vaccine.||Subjects|||Number
739102|NCT00465816|Secondary|Anti-Tetanus Toxoid (TT) Antibody Concentrations|Concentrations were provided as Geometric Mean Concentrations expressed as International Units per milliliter (IU/mL).|Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)|The analysis was performed on the According-to-Protocol cohort for immunogenicity including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Nimenrix vaccine.||International Units per milliliter||95% Confidence Interval|Geometric Mean
739103|NCT00465816|Secondary|Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135, and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values|The cut-off values assessed include greater than or equal to (≥) 0.3 micrograms per milliliter (µg/mL) and ≥ 2.0 µg/mL.|Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)|The analysis was performed on the ATP cohort for immunogenicity, only on those groups of subjects that received Nimenrix. A randomized subset of half of the subjects had sera tested for anti-PSA and anti-PSC antibodies by Enzyme-linked Immunosorbent assay (ELISA) while the other half were tested for anti PSW-135 and anti-PSY antibodies by ELISA.||Subjects|||Number
739104|NCT00465816|Secondary|Anti-PSA (Polysaccharide A), Anti-PSC (Polysaccharide C), Anti-PSW-135 (Polysaccharide W-135), and Anti-PSY (Polysaccharide Y) Antibody Concentrations|Concentrations were provided as Geometric Mean Concentrations expressed as micrograms per milliliter (µg/mL).|Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)|The analysis was performed on the ATP cohort for immunogenicity, only on those groups of subjects that received Nimenrix. A randomized subset of half of the subjects had sera tested for anti-PSA and anti-PSC antibodies by Enzyme-linked Immunosorbent assay (ELISA) while the other half were tested for anti PSW-135 and anti-PSY antibodies by ELISA.||micrograms per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
739105|NCT00465816|Secondary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values|The cut-off values assessed were greater than or equal to (≥) 1:8 and ≥ 1:128.|Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)|The analysis was performed on the According-to-Protocol cohort for immunogenicity including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Nimenrix vaccine.||Subjects|||Number
739106|NCT00465816|Secondary|Number of Subjects With a Vaccine Response to MenA, MenC, MenY and MenW-135|Vaccine response is defined as an rSBA titer of at least 1:32 in subjects initially seronegative [rSBA titer below1:8] and as a 4-fold increase in titer in subjects initially seropositive [rSBA titre greater than or equal to 1:8].|At 1 month after vaccination with Nimenrix vaccine (Month 1)|The analysis was performed on the According-to-Protocol cohort for immunogenicity including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Nimenrix vaccine.||Subjects|||Number
739107|NCT00465816|Primary|Number of Subjects Seroprotected for Hepatitis B|A seroprotected subject was defined as a subject with anti-Hepatitis B surface antigen (HBs) antibody concentration greater than or equal to 10 milli-International Units per Milliliter (mIU/mL).|At 1 month after the third dose of Twinrix vaccine (Month 7)|The analysis was performed on the According-to-Protocol cohort for immunogenicity including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Twinrix vaccine.||Subjects|||Number
739108|NCT00465816|Primary|Number of Subjects Seroconverted for Hepatitis A|A seroconverted subject was defined as a subject with anti-Hepatitis A virus (HAV) antibody concentration greater than or equal to 15 milli-International Units per Milliliter (mIU/mL) in previously seronegative subjects.|At 1 month after the third dose of Twinrix vaccine (Month 7)|The analysis was performed on the According-to-Protocol cohort for immunogenicity including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on initially seronegative subjects in those groups that received the Twinrix vaccine.||Subjects|||Number
739109|NCT00465816|Primary|Meningococcal Polysaccharide A Serum Bactericidal Antibodies/Assay, Using Baby Rabbit Complement for Assay (rSBA-MenA), rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers|The rSBA titers were expressed as geometric mean titers.|At 1 month after vaccination with Nimenrix vaccine (Month 1)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Nimenrix vaccine.||Titer||95% Confidence Interval|Geometric Mean
739110|NCT00465894|Secondary|Subjective Patient Improvement in Irritative Urinary Symptoms at 24 and 52 Weeks Post Intervention Initiation|"OAB-q Symptom Bother Score
Health Related Quality of Life (HRQL) portion of the OAB-q
Patient Global Impression of Improvement (PGI-I)
Patient Satisfaction Questionnaire (PSQ)"|After 24 and 52 Weeks of Intervention||06/2017||||
739111|NCT00465894|Secondary|Subjective Patient Improvement in Irritative Urinary Symptoms at 12 Weeks Post Intervention Initiation|"Health Related Quality of Life (HRQL) portion of the OAB-q
Patient Global Impression of Improvement (PGI-I)
Patient Satisfaction Questionnaire (PSQ)
3-Day Voiding Diary"|After 12 Weeks of Intervention||06/2017||||
739112|NCT00465894|Primary|Subjective Patient Improvement in Irritative Urinary Symptoms as Measured by the Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at 12 Weeks Post Intervention Initiation|OAB-q scoring ranges from a lowest score of 8 to the highest score of 48. The higher score reflects greater severity of symptoms. The derived score is (actual score - lowest raw score) divided by possible raw score range (40) times 100. Hence, the lowest score is 0 and the highest score is 100, with 100 being indicative or greater symptom severity. The mean and the standard deviation is reported for both arms.|After 12 Weeks of Intervention|||units on a scale|of Partipants at 12 Weeks|Standard Deviation|Mean
739113|NCT00450073|Secondary|Parathyroid Hormone, Serum C-telopeptide, Osteocalcin||12 weeks||||||
739114|NCT00450073|Primary|25-hydroxyvitamin D|This is a marker of vitamin D status|12 weeks|||ng/mL||Standard Deviation|Mean
739115|NCT00455520|Secondary|Change From Baseline in Brief Pain Inventory (BPI) Total Pain Score Over the Last Week of the Maintenance Period at Week 12.|"Total pain score where zero equals no pain to ten equals pain as bad as you can imagine from 12 week endpoint vs baseline."|Baseline and12 week endpoint|Intent to Treat (ITT) analysis set included all randomized subjects who took at least one dose of study medication during the double blind maintenance period with the exception of 3 subjects who were enrolled in the study twice.||Scores on a scale||Standard Deviation|Mean
739116|NCT00455520|Secondary|Change From Baseline in Sleep Latency Time in Hours Over the Last Week of the Maintenance Period at Week 12.|"A Sleep Questionnaire addressed the following question: How long after bedtime/lights out did you fall asleep last night (hours)? 12 week endpoint-mean changes from baseline at endpoint for sleep latency. Decrease in time (hours) indicates improvement."|Baseline and 12 week endpoint|Intent to Treat (ITT) analysis set included all randomized subjects who took at least one dose of study medication during the double blind maintenance period with the exception of 3 subjects who were enrolled in the study twice.||Hours||Standard Deviation|Mean
739117|NCT00455520|Secondary|Change From Baseline in EuroQol-5 (EQ-5D) Health Status Index to Week 12|"Change from baseline to end point in EuroQol-5 Dimension Questionnaire. A higher score indicates an improvement in health in the Health Status Index. The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating full health and 0 representing dead."|12 week endpoint (change from baseline)|Intent to Treat (ITT) analysis set included all randomized subjects who took at least one dose of study medication during the double blind maintenance period with the exception of 3 subjects who were enrolled in the study twice.||scores on a scale||Standard Deviation|Mean
739118|NCT00455520|Secondary|Percentage of Patients Who Reported Very Much Improved or Much Improved From Baseline in Patient Global Impression of Change Over the Last Week of the Maintenance Period at Week 12|Percentage of patients who reported very much improved (1) or much improved (2) based on an ordinal measure indicating change from start of double blind treatment (on a scale of 7 = Very much worse to 1 = Very much improved)|12 week endpoint|Intent to Treat (ITT) analysis set included all randomized subjects who took at least one dose of study medication during the double blind maintenance period with the exception of 3 subjects who were enrolled in the study twice.||percentage of patients|||Number
739119|NCT00455520|Secondary|The Number of Patients Achieving at Least 30% Improvement in Pain Score at Week 12 of the Double-blind Maintenance Period From the Start of the Open Label Period.|The number of patients achieving at least 30% improvement in pain score at Week 12 of the double-blind maintenance period on an 11-point numerical rating scale compared with the start of the open-label period.|Start of Open Label and at 12 weeks of Double Blind|Intent-to-treat analysis set.||participants|||Number
739120|NCT00455520|Primary|Change From Baseline (at Randomization) in Average Pain Intensity on an 11-point Numerical Rating Scale (NRS) Over the Last Week of the Double-blind Maintenance Period at Week 12|"For this twice daily pain assessment, the subjects were to indicate the level of pain experienced over the previous 12 hours on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Baseline and 12 weeks|Intent to Treat (ITT) analysis set included all randomized subjects who took at least one dose of study medication during the double blind maintenance period with the exception of 3 subjects who were enrolled in the study twice.||scores on a scale||Standard Deviation|Mean
739121|NCT00455533|Primary|Percentage of Participants Achieving Pathologic Complete Response (pCR) in 20- and 26-Gene Model Subgroups|For each of the 2 biomarker sets (20-gene or 26-gene), a multi-gene model was built using penalized logistic regression on all pharmacogenomic evaluable subjects for each treatment arm separately. Receiver Operating Characteristic (ROC) plots for separate arm using 5 fold cross validation were generated. ROC for separate arms using cross over were also added. Further analysis on the multiple gene models (as mentioned in the SAP) was planned only based on the initial findings from the 2 ROC plots. For 20- and 26-gene models, ROC curves generated for each study arm did not indicate that these multi-gene models differentially predicted for pCR between the treatment arms, so further analyses to estimate the optimal cut-off and the pCR rates were not conducted.|pCR evaluated at time of surgery (4-6 weeks after the last dose of therapy); mandatory tumor tissue biopsy obtained prior to treatment.|For 20- and 26-gene models, ROC curves generated for each study arm did not indicate that these multi-gene models differentially predicted for pCR between the treatment arms, so further analyses to estimate the optimal cut-off and the pCR rates were not conducted.|||||
739122|NCT00455533|Secondary|Number of Participants With Dose Delay and Reason for Dose Delay for Ixabepilone/Paclitaxel||12 weeks (4 3-week cycles for ixabepilone and 12 weekly doses for paclitaxel)|ixabepilone- and paclitaxel-treated participants with at least 2 courses of Ixabepilone/Paclitaxel||participants|||Number
739123|NCT00455533|Secondary|Number of Participants With Course Delay and Reason for Delay for AC||12 weeks (4 3-week cycles)|ixabepilone- and paclitaxel-treated participants with at least 2 courses of AC||participants|||Number
739124|NCT00455533|Secondary|Reason for First Dose Reduction of Ixabepilone/Paclitaxel||12 weeks (4 3-week cycles for ixabepilone and 12 weekly doses for paclitaxel)|ixabepilone- and paclitaxel-treated participants with at least 2 courses of Ixabepilone/Paclitaxel||participants|||Number
739125|NCT00455533|Secondary|Reason for First Dose Reduction of AC||12 weeks (4 3-week cycles)|ixabepilone- and paclitaxel-treated participants with at least 2 courses of AC||participants|||Number
739126|NCT00455533|Secondary|Number of Participants by Dose for Ixabepilone/Paclitaxel||12 weeks (4 3-week cycles for ixabepilone and 12 weekly doses for paclitaxel)|ixabepilone- and paclitaxel-treated participants||participants|||Number
739127|NCT00455533|Secondary|Number of Participants by Dose for AC||12 weeks (4 3-week cycles)|ixabepilone- and paclitaxel-treated participants||participants|||Number
739128|NCT00455533|Secondary|On-Study Renal Function: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death)|prior to the first study treatment, at the beginning of each subsequent cycle, weekly during the treatment period and a minimum of 4 weeks after the last dose of 12 weeks of study therapy during ixabepilone or paclitaxel treatment phase|Ixabepilone/Paclitaxel treated participants for whom on-study labs were recorded.||Participants|||Number
739129|NCT00455533|Secondary|On-Study Liver Function: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase|Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST). AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death)|prior to the first study treatment, at the beginning of each subsequent cycle, weekly during the treatment period and a minimum of 4 weeks after the last dose of study therapy during ixabepilone or paclitaxel treatment phase|Ixabepilone/Paclitaxel treated participants for whom on-study labs were recorded; n=number of participants with specific laboratory evaluation.||Participants|||Number
739130|NCT00455533|Primary|Percentage of Participants Achieving Pathologic Complete Response (pCR) in Biomarker-Defined Populations|Beta III tubulin positivity determined by cross-validation method. Optimal cutoff: ≥46% tumor cells staining at 2 plus or 3 plus intensity (corresponding Beta III tubulin positivity=39.4%). Pre-specified cutoff of Beta III tubulin positivity: ≥50% 2plus or 3plus cells (corresponding prevalence=38.5%). Optimal cutoffs for TACC3 and CAPG positivity determined by cross-validation method: 6.889 and 6.844 [log2 normalized intensity units], respectively (corresponding to prevalence rates of 43.3% and 44.3%).|pCR evaluated at time of surgery (4-6 weeks after the last dose of therapy); mandatory tumor tissue biopsy obtained prior to treatment.|For all subgroups other than Beta-III positive/negative subgroup based on a pre-determined cutoff, results were estimated using a cross-validation method (a resampling based technique, making individual sample size [N] not applicable).||Percentage of Participants||90% Confidence Interval|Number
739131|NCT00455533|Secondary|On-Study Hematology: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death)|prior to the first study treatment, at the beginning of each subsequent cycle, weekly during the treatment period and a minimum of 4 weeks after the last dose of 12 weeks of study therapy during ixabepilone or paclitaxel treatment phase|Ixabepilone/Paclitaxel treated participants for whom on-study labs were recorded.||Participants|||Number
739132|NCT00455533|Secondary|Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class|MCT=musculoskeletal and connective tissue, GDASC=general disorders and administration site conditions, RTM=respiratory, thoracic and mediastinal disorders, NBMUCP=neoplasms benign, malignant and unspecified (including cysts and polyps). Drug related adverse events are those events with relationship to study therapy of certain, probable, possible or missing. Subjects may have more than one event within a class. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death)|prior to the first study treatment, at the beginning of each subsequent cycle, weekly during the treatment period and a minimum of 4 weeks after the last dose of 12 weeks of study therapy|Ixabepilone- and Paclitaxel-treated participants||Participants|||Number
739133|NCT00455533|Secondary|Overall Safety Summary: Deaths, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Drug-Related AEs, and Most Common Treatment-Related Non-Hematologic Adverse Events (TNAEs) Occuring in >=10% of Participants|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. By Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grades|prior to the first study treatment, at the beginning of each subsequent cycle, weekly during the treatment period and a minimum of 4 weeks after the last dose of 12 weeks of study therapy|||Participants|||Number
739134|NCT00455533|Secondary|Prevalence of Biomarker Based on Optimal Threshold (Biomarker Positive Participants)|Percentage of participants having the following optimal biomarker thresholds as computed from the cross-validation method (cutoff of biomarker positive [with 90% confidence interval by Bootstrap method]): Beta 3 Tubulin IHC (45.866 [5, 83.9]); TACC3 mRNA (6.714 [6.312, 7.192]); CAPG mRNA (6.739 [5.728, 7.298]). Optimal thresholds for a 20-gene model and a 26-gene model were also planned; however, these were not determined because preliminary analyses did not indicate that they would not differentiate pCR rates between treatment arm.|pCR evaluated at time of surgery (4-6 weeks after the last dose of 12 weeks of therapy); mandatory tumor tissue biopsy and mRNA samples obtained prior to treatment|Randomized participants with non-missing pCR and biomarker expressions. n=the number of participants with specific biomarker expression.||Percentage of Participants||90% Confidence Interval|Number
739135|NCT00455533|Secondary|Percentage of Participants With pCR and MDR1 Immunohistochemistry (IHC) Positivity Using Two Pre-specified Thresholds, Estrogen-Receptor (ER) Negative Participants|Percentage of ER negative participants with pCR and MDR1 immunohistochemistry (IHC) positivity using 2 pre-specified thresholds, stratified by biomarker status. The first pre-specified threshold for MDR1-positivity (Mem)=Any membrane staining. The second pre-specified threshold for MDR1-positivity (Mem+Cyto)=Any membrane staining or at least 200 Cytoplasmic H-score.|pCR evaluated at time of surgery (4-6 weeks after the last dose of 12 weeks of therapy); mandatory tumor tissue biopsy obtained prior to treatment.|Randomized estrogen negative participants with non-missing pCR and biomarker expression||percentage of participants||90% Confidence Interval|Number
739136|NCT00455533|Secondary|Percentage of Participants With pCR/RCB1 and MDR1 Immunohistochemistry (IHC) Positivity Using Two Pre-specified Thresholds|Percentage of participants with pCR/RCB1 in MDR1 IHC positive and negative groups using 2 pre-specified thresholds,. The first pre-specified threshold for MDR1-positivity (Mem) =Any membrane staining. The second pre-specified threshold for MDR1-positivity (Mem+Cyto)=Any membrane staining or at least 200 Cytoplasmic H-score .|pCR evaluated at time of surgery (4-6 weeks after the last dose of 12 weeks of therapy); mandatory tumor tissue biopsy obtained prior to treatment.|Randomized participants with non-missing pCR/RCB1 and biomarker expression||percentage of participants||90% Confidence Interval|Number
739137|NCT00455533|Secondary|Percentage of Participants With pCR and MDR1 Immunohistochemistry (IHC) Positivity Using Two Pre-Specified Thresholds|Percentage of participants with pCR in MDR1 IHC positive and negative groups using 2 pre-specified thresholds,. The first pre-specified threshold for MDR1-positivity (Mem) =Any membrane staining. The second pre-specified threshold for MDR1-positivity (Mem+Cyto)=Any membrane staining or at least 200 Cytoplasmic H-score.|: pCR evaluated at time of surgery (4-6 weeks after the last dose of 12 weeks of therapy); mandatory tumor tissue biopsy obtained prior to treatment.|Randomized participants with non-missing pCR and biomarker expression||percentage of participants||90% Confidence Interval|Number
739308|NCT00467649|Secondary|Phase 2: Change in Body Weight at Week 36|Two changes are calculated, the first by subtracting Week 36 value from the Phase 1 Baseline value (total change over 36 weeks), the second by subtracting the Week 36 value from the Phase 2 Baseline value (change from week 24 to week 36 only).|Phase 1 Baseline, Phase 2 Baseline at Week 24, Week 36|Phase 2 Intent-to-Treat||kg||Standard Error|Mean
739138|NCT00455533|Secondary|Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]) to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR/RCB1|Relevance of biomarker in differentiation between ixabepilone & paclitaxel evaluated by logistic regression with pCR/RCB1 as response. Statistical analyses include: 1) likelihood ratio test between the full model (pCR/RCB1~Biomarker:Treatment: ER) & reduced model (pCR/RCB1~Treatment:ER); 2) likelihood ratio test between the full model (pCR/RCB1 Biomarker:Treatment) & reduced model (pCR/RCB1~Biomarker+Treatment); 3) contrast of the interaction between treatment & biomarker expression within ER Negative subjects from the full model (pCR/RCB1~Biomarker:Treatment:ER). A:B represents A,B & A*B.|pCR evaluated at time of surgery (4-6 weeks after the last dose of therapy); mandatory tumor tissue biopsy obtained prior to treatment.|||participants|||Number
739139|NCT00455533|Secondary|Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]), to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR|Relevance of biomarker in differentiation between ixabepilone & paclitaxel evaluated by logistic regression with pCR as response. Statistical analyses include: 1) the likelihood ratio test between the full model (PCR~Biomarker:Treatment:estrogen receptor [ER]) & reduced model (PCR~Treatment:ER); 2) the likelihood ratio test between the full model (PCR~Biomarker:Treatment) & reduced model (PCR~Biomarker+Treatment); 3) the contrast of the interaction between treatment & biomarker expression within ER Negative subjects from the full model(PCR~Biomarker:Treatment:ER). A:B represents A,B & A*B.|pCR evaluated at time of surgery (performed 4-6 weeks after the last dose of 12 weeks of therapy); mandatory tumor tissue biopsy obtained prior to treatment.|||participants|||Number
739140|NCT00455533|Secondary|Percentage of Participants Achieving Combined pCR and Minimal Residual Cancer Burden (RCB) 1|Combined pCR and RCB-1 was defined as participants with no histologic evidence of residual invasive adenocarcinoma in the breast and axillary lymph nodes, with or without the presence of DCIS in the breast plus subjects with RCB-1 following the RCB calculation based on data entered by the investigator sites in each arm.|at surgery (performed 4-6 weeks after the last dose of 12 weeks of therapy)|All randomized participants||Percentage of Participants||90% Confidence Interval|Number
739141|NCT00455533|Secondary|Percentage of Participants Requiring Breast Conservation Surgery|Number of randomized participants requiring breast conservation surgery following study treatment.|at surgery (performed 4-6 weeks after the last dose of 12 weeks of therapy)|All randomized participants||Percentage of Participants||90% Confidence Interval|Number
739142|NCT00455533|Secondary|Percentage of Participants Achieving Clinical Objective Response|Clinical response was defined as the number of participants who achieved modified World Health Organization’s tumor response criteria of clinical complete response (complete disappearance of all clinically palpable detectable malignant disease and/or disappearance of radiological evidence of tumor in the breast and ipsilateral axillary lymph nodes) or clinical partial response (clinical evidence of a reduction in total tumor size of >= 50% in the overall sum of the products of diameters of breast and axillary lesions), divided by the number of randomized participants in that arm.|after the last dose of either ixabepilone or paclitaxel (at 12 weeks) but before surgery (4-6 weeks after the last dose of 12 weeks of therapy)|All randomized participants||Percentage of Participants||90% Confidence Interval|Number
739143|NCT00455533|Primary|Percentage of Participants Achieving Pathologic Complete Response (pCR)|The pCR was defined as no histologic evidence of residual invasive adenocarcinoma in the breast and axillary lymph nodes, with or without the presence of ductal carcinoma in situ (DCIS) in the breast.|at surgery (performed 4-6 weeks after the last dose of 12 weeks of therapy)|All randomized participants||Percentage of Participants||90% Confidence Interval|Number
739144|NCT00465972|Secondary|Change in Piper Fatigue Scale at 3 Months|A 22 item scale measuring level of fatigue, with possible totals ranging from 22-220. A higher number indicates greater severity of fatigue.|Baseline and 3 months|||units on a scale||Standard Deviation|Mean
739145|NCT00465972|Primary|Response: Change in Insomnia Severity Rating Scale at 3 Months.|Insomnia Severity Index; It is a measure of Insomnia Severity; A higher number indicates greater severity of insomnia. Range of possible score totals is 0-28.|Baseline and 3 months|This is the LOCF population||units on a scale||Standard Deviation|Mean
739146|NCT00465985|Secondary|Pharmacodynamics Measured by Interleukin-1β (IL-1β) Concentrations at End of Part III.||48 weeks after study start|Intention to treat (ITT) population.||pg/mL||Standard Deviation|Mean
739147|NCT00465985|Secondary|Pharmacodynamics Measured by Interleukin-1β (IL-1β) Concentrations at End of Part II.||32 weeks after study start|Intention to treat (ITT) population.||pg/mL||Standard Deviation|Mean
739148|NCT00465985|Secondary|Pharmacodynamics Measured by Interleukin-1β (IL-1β) Concentrations at End of Part I.||until Week 8|Intention to treat (ITT) population.||pg/mL||Standard Deviation|Mean
739149|NCT00465985|Primary|Number of Participants Who Experienced a Disease Flare in Part II|Disease flare is determined by the Physician's global assessment of autoinflammatory disease activity, assessment of skin disease and inflammation markers. Disease Flare = the C-reactive protein and/or serum amyloid A (SAA) > 30 mg/L and either a PGA > minimal, or PGA equal to minimal and > minimal SD.|32 weeks after study start|||Participants|||Number
739150|NCT00465985|Secondary|Pharmacokinetics (CLD (L/d))|Assessed serum clearance of ACZ885.|48 weeks after study start|Patients in Part I and Part II who received at least one dose of ACZ885.||L/day||Standard Deviation|Mean
739151|NCT00465985|Secondary|Change in Inflammation Markers at the End of Part II (C-reactive Protein and/or Serum Amyloid A) (After 24 Weeks of the Double-blind Part) From Week 8.||Week 8 and Week 32|Intention to treat (ITT)population and LOCF.||mg/L||Standard Deviation|Mean
739152|NCT00465985|Secondary|Investigator's Clinical Assessment of Autoinflammatory Disease Activity & Participant's Assessment of Symptoms at End of Part II (After 24 Weeks of the Double-blind Part)|"A 5-point scale was used for the Physician’s global assessment on autoinflammatory disease activity (absent, minimal, mild, moderate and severe) and for the assessment of the following items:
skin disease (urticarial skin rash)
arthralgia
myalgia
headache/migraine
conjunctivitis
fatigue/malaise
other symptoms related to autoinflammatory syndrome
other symptoms not related to autoinflammatory syndrome"|32 weeks after study start|||Participants|||Number
739423|NCT00467870|Secondary|Serum Total Testosterone Concentrations in Part C2||Screening; day 0; days 0, 4, 7, 11, and 14 post injection at week 4; weeks 14, 24, 34, and 44|Total patient sample/PK sample includes participants who were enrolled, received injection 2, and had at least 1 post-injection 2 IPK sample (no participants were excluded)||ng/dL||Standard Deviation|Mean
739153|NCT00465985|Secondary|Number of Participants With Treatment Response in Part I (After 8 Weeks)|Treatment response was based on Physician's global assessment(PGA) of autoinflammatory disease activity, assessment of skin disease(SD) and serum values of C-reactive protein(CRP) and/or serum amyloid A(SAA). Complete Response (CR):PGA and SD ≤ minimal and normal CRP and/or SAA. Partial Response (PR): a reduction of CRP and/or SAA from baseline (BL) by >30% but not reaching normal values and PGA improvement from BL by at least one category. Disease flare: a CRP and/or SAA > 30 mg/L and either PGA > minimal or PGA = minimal and SD > minimal. Non-responders = no PR by Day 8 or no CR by Day 15.|8 weeks after study start|||Participants|||Number
739154|NCT00465985|Primary|Percent of Participants With Disease Flare in Part II (After 24 Weeks of the Double-blind Part)|Determined by the Physician's global assessment of autoinflammatory disease activity, assessment of skin disease and inflammation markers. Data expressed as a percent of participants who had experienced a flare by the end of Part II.|32 weeks after study start|||percent of participants|||Number
739155|NCT00465998|Secondary|Delivery Within 24 Hours|Association between parity, HPD, cervical length, cervical angle, occiput posterior position, parity, BMI and the Hazard ratio of delivering within 24 hours was investigated using Cox regression analysis.|Time from induction to delivery|Hazard ratio was reported.||Hazard ratio||95% Confidence Interval|Number
739156|NCT00465998|Primary|Vaginal Delivery in Induced Labors|The association between Bishop score, ultrasound assessed fetal station, ultrasound assessed cervical length, cervical posterior angle and a vaginal delivery was investigated using area under the ROC curves. Fetal station was assessed by ultrasound as the fetal head–perineum distance (HPD); which was measured by transperineal ultrasound imaging as the shortest distance from the outer bony limit of the fetal skull to the skin surface of the perineum.|Time from induction of labor to delivery|||percentage of area under the ROC curve||95% Confidence Interval|Number
739157|NCT00466167|Secondary|Clinically Significant Abnormalities: Clinical Laboratory Evaluations (Biochemistry and Haematology)||baseline and week 18|Treated set (TS 1) population: defined as all patients who were dispensed study medication, were documented to have at least one dose of study medication and were treated for 18 weeks (or had discontinued treatment prior to week 18). Data limited to visit 8 (or V11 in case of premature discontinuation before visit 8).||participants|||Number
739158|NCT00466167|Secondary|Change From Baseline in 11-point Likert Scale for Pain Related to PD at Week 18|Likert scale is a method used for the measurement of pain. The patients were asked to rate their pain related to PD by ticking the number that best described their pain on the average in the previous week, from zero for “no pain” to ten for “unbearable pain”.|baseline and week 18|Full analysis set (FAS 1) population with last observation carried forward (LOCF).||units on a scale||Standard Error|Least Squares Mean
739159|NCT00466167|Secondary|Change From Baseline in European Quality of Life (EuroQol) Scale After 18 Weeks|ranging from 0 (worst case) to 100 (best case)|baseline and 18 weeks|Full analysis set (FAS 1) population with last observation carried forward (LOCF).||Units on a scale||Standard Error|Least Squares Mean
739160|NCT00466167|Secondary|Change From Baseline in Parkinson's Disease Quality of Life Questionnaire 39 After 18 Weeks|Ranging from 0 (best case) to 156 (worst case)|baseline and 18 weeks|Full analysis set (FAS 1) population with last observation carried forward (LOCF).||Units on a scale||Standard Error|Least Squares Mean
739161|NCT00466167|Secondary|Change From Baseline in Parkinson's Disease Sleep Scale (PDSS) After 18 Weeks|ranging from 0 (worst case) to 150 (best case)|baseline and 18 weeks|Full analysis set (FAS 1) population with last observation carried forward (LOCF).||Units on a scale||Standard Error|Least Squares Mean
739162|NCT00466167|Secondary|Change From Baseline in Beck's Depression Inventory (BDI) After 18 Weeks|ranging from 0 (best case) to 63 (worst case)|baseline and 18 weeks|Full analysis set (FAS 1) population with last observation carried forward (LOCF).||Units on a scale||Standard Error|Least Squares Mean
739163|NCT00466167|Secondary|Change From Baseline in UPDRS IV Score After 18 Weeks|UPDRS IV ranging from 0 (normal) to 23 (severe). UPDRS IV measures complications of therapy|baseline and 18 weeks|Full analysis set (FAS 1) population with last observation carried forward (LOCF).||Units on a scale||Standard Error|Least Squares Mean
739164|NCT00466167|Secondary|Change From Baseline in UPDRS III Score After 18 Weeks|UPDRS III ranging from 0 (normal) to 108 (severe). UPDRS part III measures motor symptoms|baseline and 18 weeks|Full analysis set (FAS 1) population with last observation carried forward (LOCF).||Units on a scale||Standard Error|Least Squares Mean
739165|NCT00466167|Secondary|Change From Baseline in UPDRS II Score After 18 Weeks, Average at on and Off-period|UPDRS II ranging from 0 (normal) to 52 (severe). UPDRS Part II is calculated as the average of UPDRS part II at on and UPDRS part II at off-period for each of the 13 activities.|baseline and 18 weeks|Full analysis set (FAS 1) population with last observation carried forward (LOCF).||Units on a scale||Standard Error|Least Squares Mean
739166|NCT00466167|Secondary|Change From Baseline in UPDRS I Score After 18 Weeks|UPDRS I ranging from 0 (normal) to 16 (severe). UPDRS I measures Mentation, Behavior and Mood|baseline and 18 weeks|Full analysis set (FAS 1) population with last observation carried forward (LOCF).||Units on a scale||Inter-Quartile Range|Median
739167|NCT00466167|Secondary|Response in Patient Global Impression (PGI-I)|PGI-I scores ranging from '1' (very much better) to '7' (very much worse), PGI-I responder have scoring 1 or 2 (at least much better)|after 18 weeks of treatment|Full analysis set (FAS 1) population with last observation carried forward (LOCF).||Participants|||Number
739168|NCT00466167|Secondary|Clinical Global Impression - Global Improvement (CGI-I) Responder|CGI-I scores ranging from '1' (very much improved) to '7' (very much worse), CGI-I responder have scoring of 1 or 2 (at least much improved)|after 18 weeks of treatment|Full analysis set (FAS 1) population with last observation carried forward (LOCF).||Participants|||Number
739169|NCT00466167|Secondary|Change From Baseline in Percentage On-time With Troublesome Dyskinesia at Week 18|Percentage on-time with troublesome dyskinesia based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.|baseline and week 18|Full analysis set (FAS 1) population with last observation carried forward (LOCF).||Percentage of on-time||Standard Error|Least Squares Mean
739309|NCT00467649|Secondary|Phase 2: Change in HbA1c at Week 36|Two changes are calculated, the first by subtracting Week 36 value from the Phase 1 Baseline value (total change over 36 weeks), the second by subtracting the Week 36 value from the Phase 2 Baseline value (change from week 24 to week 36 only).|Phase 1 Baseline, Phase 2 Baseline at Week 24, Week 36|Phase 2 Intent-to-Treat||Percent||Standard Error|Mean
739170|NCT00466167|Secondary|Change From Baseline in Percentage On-time With Non-troublesome Dyskinesia at Week 18|Percentage on-time with non-troublesome dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.|baseline and week 18|Full analysis set (FAS 1) population with last observation carried forward (LOCF).||Percentage of on-time||Standard Error|Least Squares Mean
739171|NCT00466167|Secondary|Change From Baseline in Percentage On-time Without Dyskinesia at Week 18|Percentage on-time based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.|baseline and week 18|Full analysis set (FAS 1) population with last observation carried forward (LOCF).||Percentage of on-time without dyskinesia||Standard Error|Least Squares Mean
739172|NCT00466167|Secondary|Change From Baseline in Percentage Off-time at Week 18|Percentage off-time based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). Off-time describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease).|baseline and week 18|Full analysis set (FAS 1) population with last observation carried forward (LOCF).||Percentage of off-time||Standard Error|Least Squares Mean
739173|NCT00466167|Primary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts II+III Score at Week 18|UPDRS II+III total score on Full Analysis Set (FAS)with LOCF (Last observation carried forward), week 18 - baseline, UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms|baseline and week 18|Full analysis set (FAS 1) population = 507 patients FAS 1 defined as all patients who were dispensed study medication, were documented to have at least one dose of study medication, were treated for 18 weeks (or had prematurely discontinued treatment prior to week 18) and provided baseline and any on-drug post-baseline efficacy assessment||Percentage of change from baseline||Standard Error|Least Squares Mean
739174|NCT00466193|Secondary|Morning Sleepiness Rating Following Dosing Post Middle-of-the-Night Awakening During Double-blind Treatment|Morning sleepiness was assessed using a 9-point sleepiness scale (1=very sleepy to 9=wide awake and alert). Values are from dosing nights during double-blind treatment.|Weeks 1 to 4|Safety population: participants who took at least one dose of study medication post-randomization.||units on a scale||95% Confidence Interval|Least Squares Mean
739175|NCT00466193|Primary|Latency to Sleep Onset After Middle-of-the-Night Awakening During Double-blind Treatment|Time was recorded by study participants using a telephone interactive voice response system (IVRS) to answer the question: How long did it take you to fall asleep after taking your study medication?|Weeks 1 to 4|Efficacy population: randomized participants who took at least one dose of study medication and had at least one latency to sleep onset following a middle-of-the-night awakening value.||minutes||95% Confidence Interval|Least Squares Mean
739176|NCT00466193|Secondary|Morning Sleepiness Rating Following Dosing Post Middle-of-the-Night Awakening at Baseline|Morning sleepiness was assessed using a 9-point sleepiness scale (1=very sleepy to 9=wide awake and alert). During the baseline period, all participants received placebo.|Weeks -1 to 0|Safety population: participants who took at least one dose of study medication post-randomization.||units on a scale||95% Confidence Interval|Least Squares Mean
739177|NCT00466193|Secondary|Subjective Wake Time After Sleep Onset Following Middle-of-the-Night Awakening During Double-blind Treatment|The number of minutes subjects reported being awake after onset of sleep following middle-of-the-night awakening during double-blind treatment. Values were recorded using a telephone interactive voice response system (IVRS) to answer the question: Considering all of these awakenings (after taking study medication and returning to sleep), how long were you awake from the time you went back to sleep after dosing until you got out of bed this morning?|Weeks 1 to 4|Efficacy population: randomized participants who took at least one dose of study medication and had at least one latency to sleep onset following a middle-of-the-night awakening value.||percentage of participants|||Number
739178|NCT00466193|Secondary|Subjective Wake Time After Sleep Onset Following Middle-of-the-Night Awakening at Baseline|The number of minutes subjects reported being awake after onset of sleep following middle-of-the-night awakening during the baseline period. Values were recorded using a telephone interactive voice response system (IVRS) to answer the question: Considering all of these awakenings (after taking study medication and returning to sleep), how long were you awake from the time you went back to sleep after dosing until you got out of bed this morning?|Weeks -1 to 0|Efficacy population: randomized participants who took at least one dose of study medication and had at least one latency to sleep onset following a middle-of-the-night awakening value.||percentage of participants|||Number
739179|NCT00466193|Secondary|Subjective Number of Awakenings Following Middle-of-the-Night Awakening During Double-blind Treatment|Number of awakenings following middle-of-the-night awakening were recorded by study participants using a telephone interactive voice response system (IVRS) to answer the question: After you fell back to sleep, how many times did you wake up again before waking up in the morning?|Weeks 1 to 4|Efficacy population: randomized participants who took at least one dose of study medication and had at least one latency to sleep onset following a middle-of-the-night awakening value.||percentage of participants|||Number
739180|NCT00466193|Secondary|Subjective Number of Awakenings Following Middle-of-the-Night Awakening at Baseline.|Number of awakenings following middle-of-the-night awakening were recorded by study participants using a telephone interactive voice response system (IVRS) to answer the question: After you fell back to sleep, how many times did you wake up again before waking up in the morning?|Weeks -1 to 0|Efficacy population: randomized participants who took at least one dose of study medication and had at least one latency to sleep onset following a middle-of-the-night awakening value.||percentage of participants|||Number
739181|NCT00466193|Secondary|Subjective Total Sleep Time Following Middle-of-the-Night Awakening During Double-blind Treatment|Total sleep time in minutes after waking in the middle of the night. The values were recorded by participants using a telephone interactive voice response system (IVRS) to answer the question: After you fell back to sleep, how long did you sleep until you woke up this morning?|Weeks 1 to 4|Efficacy population: randomized participants who took at least one dose of study medication and had at least one latency to sleep onset following a middle-of-the-night awakening value.||minutes||95% Confidence Interval|Least Squares Mean
739310|NCT00467649|Secondary|Fasting Serum Lipids Change From Baseline to Week 24||Baseline, week 24|Phase 1 Intent-to-Treat||mg/dL||Standard Error|Mean
739182|NCT00466193|Secondary|Subjective Total Sleep Time Following Middle-of-the-Night Awakening at Baseline|Total sleep time in minutes after waking in the middle of the night. The values were recorded by participants using a telephone interactive voice response system (IVRS) to answer the question: After you fell back to sleep, how long did you sleep until you woke up this morning?|Weeks -1 to 0|Efficacy population: randomized participants who took at least one dose of study medication and had at least one latency to sleep onset following a middle-of-the-night awakening value.||minutes||95% Confidence Interval|Least Squares Mean
739183|NCT00466193|Primary|Latency to Sleep Onset After Middle-of-the-Night Awakening at Baseline|Time was recorded by study participants using a telephone interactive voice response system (IVRS) to answer the question: How long did it take you to fall asleep after taking your study medication?|Weeks -1 to 0|Efficacy population: randomized participants who took at least one dose of study medication and had at least one latency to sleep onset following a middle-of-the-night awakening value.||minutes||95% Confidence Interval|Least Squares Mean
739184|NCT00466206|Primary|Efficacy: Patient Recommendation of Treatment|"Based on patient response to one-year post-explantation QoL statement: I would recommend this treatment for pectus excavatum (sunken chest) to someone else with pectus excavatum. Ratings: 5-strongly agree; 4-agree; 3-unsure; 2-disagree; 1-strongly disagree"|One year post-explanation|Per protocol||Scores on a scale||Standard Deviation|Mean
739185|NCT00466206|Primary|Efficacy: Patient Satisfaction|Based on patient response to one-year post-explantation QoL questionnaire: How satisfied are you with the correction of your chest? Ratings: 5-very satisfied; 4-satisfied; 3-unsure; 2-dissatisfied; 1-very dissatisfied|One year post-explant|Per protocol||Scores on a scale||Standard Deviation|Mean
739186|NCT00466206|Primary|Damage/Discoloration to Skin|Outcome measure is number of patients who experienced permanent skin damage or discoloration due to external brace wear|One-month post-explant|Per protocol||participants|||Number
739187|NCT00466206|Secondary|Patient Compliance|Compliance measured by average number of hours per day external device was worn by patient, as measured by the data sensor and logging device built into external prosthetic|18 months active Rx|Per protocol||avg hours per day brace worn||Full Range|Mean
739188|NCT00466206|Primary|Affect on Cardiac Activity|EKG performed prior to implantation, one month post-implantation, and after explanation to evaluate whether magnetic field near the heart adversely affects cardiac activity. Outcome measure describes number of patients who experienced adverse change in EKG.|One month post-explantation|Per protocol, this is a single-arm, pilot study of ten subjects.||participants|||Number
739189|NCT00466947|Secondary|Number of Subjects With Anti-protein D (ANTI-PD) Antibody Concentrations >= 100 Enzyme-linked Immunosorbent Assay Units Per Milliliter ( EL.U/mL), in the Immunogenicity and Tolerability Subset.|A seropositive subject was defined as a subject with ANTI-PD antibody concentrations >= 100 EL.U/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 Post-BST and M9 POST-BST|Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Safety Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.||Subjects|||Number
739190|NCT00466947|Secondary|Number of Subjects With Anti-protein D (ANTI-PD) Antibody Concentrations >= 100 Enzyme-linked Immunosorbent Assay Units Per Milliliter ( EL.U/mL), in the Immunogenicity and Tolerability Subset|A seropositive subject was defined as a subject with ANTI-PD antibody concentrations >= 100 EL.U/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|At Month 5, one month after the third dose of primary vaccination|Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.||Subjects|||Number
739191|NCT00466947|Secondary|Concentrations of Antibodies Against Protein D (ANTI-PD), in the Immunogenicity and Tolerability Subset|ANTI-PD concentrations are expressed as geometric mean concentrations (GMCs), in enzyme-linked immunosorbent assay (ELISA) unit per milliliter (EL.U/mL). The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 Post-BST and M9 POST-BST)|Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.||EL.U/mL||95% Confidence Interval|Geometric Mean
739192|NCT00466947|Secondary|Concentrations of Antibodies Against Protein D (ANTI-PD), in the Immunogenicity and Tolerability Subset|ANTI-PD concentrations are expressed as geometric mean concentrations (GMCs), in enzyme-linked immunosorbent assay (ELISA) unit per milliliter (EL.U/mL). The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|At Month 5, one month after the third dose of primary vaccination|Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.||EL.U/mL||95% Confidence Interval|Geometric Mean
739193|NCT00466947|Secondary|Number of Subjects With Titers for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A >= 8, in the Immunogenicity and Tolerability Subset|A seropositive subject was a subject with titers for opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A >= 8. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST).|Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.||Subjects|||Number
739311|NCT00467649|Secondary|Change in Fasting Plasma Glucose From Baseline at Week 24|Baseline values are presented in the Baseline Characteristics section|From Baseline to Week 24|Phase 1 Intent-to-Treat||mg/dL||Standard Error|Mean
739194|NCT00466947|Secondary|Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset|A seropositive subject was defined as a subject with titers for opsonophagocytic activity against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST)|Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.||Subjects|||Number
739195|NCT00466947|Secondary|Number of Subjects With Titers for Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A >= 8, in the Immunogenicity and Tolerability Subset|A seropositive subject was defined as a subject with titers for opsonophagocytic activity against cross-reactive pneumococcal serotypes 6A and 19A >= 8. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|At Month 5, one month after the third dose of primary vaccination|Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.||Subjects|||Number
739196|NCT00466947|Secondary|Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F => 8, in the Immunogenicity and Tolerability Subset|A seropositive subject was defined as a subject with titers for opsonophagocytic activity against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|At Month 5, one month after the third dose of primary vaccination|Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.||Subjects|||Number
739197|NCT00466947|Secondary|Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 6A and 19A in the Immunogenicity and Tolerability Subset|The cut-off of the assay was >= 8. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST)|Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.||Titers||95% Confidence Interval|Geometric Mean
739198|NCT00466947|Secondary|Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset|The cut-off of the assay was >= 8. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST)|Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.||Titers||95% Confidence Interval|Geometric Mean
739199|NCT00466947|Secondary|Titers for Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A, in the Immunogenicity and Tolerability Subset|The cut-off of the assay was >= 8. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|At Month 5, one month after the third dose of primary vaccination|Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Safety Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.||Titers||95% Confidence Interval|Geometric Mean
739200|NCT00466947|Secondary|Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset|The cut-off of the assay was >= 8. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|At Month 5, one month after the third dose of primary vaccination,|Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.||Titers||95% Confidence Interval|Geometric Mean
739201|NCT00466947|Secondary|Number of Subjects With Pneumococcal Antibody Concentrations Against Serotypes 6A and 19A >= 0.05 µg/mL, in the Immunogenicity and Tolerability Subset|A seropositive subject was defined as a subject with antibody concentrations against cross-reactive pneumococcal serotypes 6A and 19A>= 0.05 µg/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST) .|Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.||Subjects|||Number
739247|NCT00466947|Secondary|Number of Subjects With Solicited Local Symptoms Post Primary Vaccination in the Immunogenicity and Tolerability Subset|Assessed symptoms were redness, swelling and pain. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively. This outcome measure concerns solely subjects from the Synflorix Group.|Within the 4-days (Days 0–3) follow-up period across the 3 doses of the primary study vaccine administration|The analysis was performed on all vaccinated subjects included in the Immunogenicity and Tolerability subset for the primary vaccination course.||Subjects|||Number
739202|NCT00466947|Secondary|Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset|A seropositive subject was defined as a subject with antibody concentrations against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F => 0.05 µg/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST|Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.||Subjects|||Number
739203|NCT00466947|Secondary|Number of Subjects With Pneumococcal Antibody Concentrations Against Serotypes 6A and 19A >= 0.05 µg/mL, in the Immunogenicity and Tolerability Subset|A seropositive subject was defined as a subject with antibody concentrations against cross-reactive pneumococcal serotypes 6A and 19A>= 0.05 µg/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|At Month 5, one month after the third dose of primary vaccination|Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.||Subjects|||Number
739204|NCT00466947|Secondary|Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset|A seropositive subject was defined as a subject with antibody concentrations against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F => 0.05 µg/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|At Month 5, one month after the third dose of primary vaccination|Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.||Subjects|||Number
739205|NCT00466947|Secondary|Number of Subjects With Pneumococcal Antibody Concentrations Against Cross-reactive Serotypes 6A and 19A Higher >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset|Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA). The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST)|Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.||Subjects|||Number
739206|NCT00466947|Secondary|Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset|Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA). Serotypes assessed with the pneumococcal vaccine serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST)|Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.||Subjects|||Number
739207|NCT00466947|Secondary|Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset|Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA). The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|At Month 5, one month after the third dose of primary vaccination|Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.||Subjects|||Number
739208|NCT00466947|Secondary|Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset|Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA). Serotypes assessed were the pneumococcal vaccine serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|At Month 5, one month after the third dose of primary vaccination|Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.||Subjects|||Number
739209|NCT00466947|Secondary|Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A, in the Immunogenicity and Tolerability Subset|Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was >= 0.05 µg/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST)|Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.||µg/mL||95% Confidence Interval|Geometric Mean
739210|NCT00466947|Secondary|Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset.|Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). Serotypes assessed were the pneumococcal vaccine serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The cut-off of the assay was >= 0.05 µg/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST)|Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.||µg/mL||95% Confidence Interval|Geometric Mean
739211|NCT00466947|Secondary|Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A, in the Immunogenicity and Tolerability Subset|Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was >= 0.05 µg/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|At Month 5, one month after the third dose of primary vaccination|Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.||µg/mL||95% Confidence Interval|Geometric Mean
739212|NCT00466947|Secondary|Pneumococcal Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset.|Antibody concentrations were measured by 22F enzyme-linked Immunosorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). Serotypes assessed were the pneumococcal vaccine serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The cut-off of the assay was >= 0.05 µg/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|At Month 5, one month after the third dose of primary vaccination|Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.||µg/mL||95% Confidence Interval|Geometric Mean
739213|NCT00466947|Secondary|Number of Subjects With Any Antibiotic Prescription at Least Once During the Entire Study Period, in the Carriage Subset.|The Carriage Subset consisted in a subgroup of 2,000 subjects enrolled in Panama.|Throughout the study (Month 0 to Month 22-25)|The analysis was performed on all vaccinated subjects included in the carriage subset.||Subjects|||Number
739214|NCT00466947|Secondary|Number of Subjects With Acquisition of New Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs, in the Carriage Subset.|The Carriage Subset consisted in a subgroup of 2,000 subjects enrolled in Panama.|At Months 10-13, 13-16, 14-17, 16-19 and 22-25|The analysis was performed on all vaccinated subjects included in the carriage subset.||Subjects|||Number
739215|NCT00466947|Secondary|Number of Subjects With Acquisition of New Streptococcus Pneumoniae Strains Identified in Nasopharyngeal Swabs, in the Carriage Subset|The Carriage Subset consisted in a subgroup of 2,000 subjects enrolled in Panama.|At Months 10-13, 13-16, 14-17, 16-19 and 22-25|The analysis was performed on all vaccinated subjects included in the carriage subset.||Subjects|||Number
739216|NCT00466947|Secondary|Number of Subjects With H. Influenzae Strains Identified in Nasopharyngeal Swabs, in the Carriage Subset|Results included samples confirmed as positive for Haemophilus influenzae (H. influenzae) or non-typeable H. influenzae (NTHi) after differentiation from H. haemolyticus by polymerase chain reaction (PCR) assay. The Carriage Subset contained a subgroup of 2,000 subjects enrolled in Panama.|At Months 5, 10-13, 13-16, 14-17, 16-19 and 22-25|The analysis was performed on all vaccinated subjects included in the carriage subset.||Subjects|||Number
739217|NCT00466947|Secondary|Number of Subjects With Streptococcus Pneumoniae (S. pn.) Serotypes Identified in Nasopharyngeal Swabs Other Than the Synflorix Vaccine and Cross-reactive Serotypes, in the Carriage Subset|S. pn. serotypes were identified using latex agglutination and by quellung reaction with omni serum. The Carriage Subset consisted in a subgroup of 2,000 subjects enrolled in Panama.|At Months 5, 10-13, 13-16, 14-17, 16-19 and 22-25|The analysis was performed on all vaccinated subjects included in the carriage subset.||Subjects|||Number
739218|NCT00466947|Secondary|Number of Subjects With Streptococcus Pneumoniae (S. pn.) Cross-reactive Serotypes Identified in Nasopharyngeal Swabs, in the Carriage Subset.|Any serotype belonging to the same serogroup as the Synflorix vaccine serotypes, but different from the vaccine serotypes, was considered for this analysis of carriage S. pn. cross-reactive serotypes. S. pn. serotypes were identified using latex agglutination and by quellung reaction with omni serum. The Carriage Subset consisted in a subgroup of 2,000 subjects enrolled in Panama.|At Months 5, 10-13, 13-16, 14-17, 16-19 and 22-25|The analysis was performed on all vaccinated subjects included in the carriage subset.||Subjects|||Number
739219|NCT00466947|Secondary|Number of Subjects With Streptococcus Pneumoniae (S. pn.) Vaccine Serotypes Identified in Nasopharyngeal Swabs, in the Carriage Subset.|"The 10 pneumococcal S. pn. vaccine serotypes assessed for this outcome measure were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. S. pn. serotypes were identified using latex agglutination and by quellung reaction with omni serum.
The Carriage Subset consisted in a subgroup of 2,000 subjects enrolled in Panama."|At Months 5, 10-13, 13-16, 14-17, 16-19 and 22-25|The analysis was performed on all vaccinated subjects included in the carriage subset.||Subjects|||Number
739220|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Invasive Disease (ID) Due to Haemophilus Influenzae|No subject was reported with any case of ID due to Haemophilus influenzae.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25||12/2050||||
739263|NCT00467077|Secondary|Number of Participants With Overall Response as Measured by RECIST Criteria|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response = CR + PR|After 2 cycles of treatment, up to 2 years.|||participants|||Number
739221|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Invasive Pneumococcal Disease (IPD) Due to Pneumococcal Serotypes Other Than Streptococcus (S. pn.) Vaccine and Cross-reactive Serotypes.|The serotypes assessed for this outcome measure included among others the pneumococcal serotypes 12F, 16F, 24F, 38 and 8.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.||Subjects|||Number
739222|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Invasive Pneumococcal Disease (IPD) Due to Streptococcus (S. pn.) Cross-reactive Pneumococcal Serotypes.|The S. pn. cross-reactive serotypes assessed for this outcome measure were the serotypes 19A, 6A and 9N.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.||Subjects|||Number
739223|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Pneumococcal Invasive Disease (Pneumococcal ID)|A Pneumococcal ID was defined as a bacteriologically culture confirmed invasive pneumococcal disease (ID) cases due to any of the 10 Streptococcus pneumoniae vaccine serotypes. The 10 pneumococcal S. pneumoniae vaccine serotypes assessed for this outcome measure were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Pneumococcal ID cases were identified through non-culture pneumococcal diagnostic tests with additional non-culture vaccine type serotyping. Tests used included rapid in-vitro diagnostic tests or Latex agglutination.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.||Subjects|||Number
739224|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of a Bacteriologically Confirmed Invasive Pneumococcal Disease (Bact.-Conf. ID).|A Bact.-conf. ID was defined as a bacteriologically culture confirmed invasive pneumococcal disease (ID) cases due to any of the 10 Streptococcus pneumoniae vaccine serotypes as identified through positive culture. The 10 pneumococcal S. pneumoniae vaccine serotypes assessed for this outcome measure were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.||Subjects|||Number
739225|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Vaccine-type Invasive Pneumococcal Disease (VT-IPD).|A VT-IPD was defined as a bacteriologically culture confirmed invasive pneumococcal disease case caused by any of the 10 pneumococcal Streptococcus pneumoniae vaccine serotypes. The 10 pneumococcal S. pneumoniae vaccine serotypes assessed for this outcome measure were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.||Subjects|||Number
739226|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of CAP With Either Alveolar Consolidation/Pleural Effusion on Chest X-ray (CXR) (C-CAP) or With Non-alveolar Infiltrates (NAI-CAP) But With C Reactive Protein (CRP) >= Cut-off.|CRP cut-off values applied for this outcome measure were 80 milligrams per liter (mg/L), and 120 mg/L.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.||Subjects|||Number
739227|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Suspected Community Acquired Pneumoniae (CAP) (S-CAP) With C Reactive Protein (CRP) >= Cut-off, Regardless of Chest X-ray (CXR) Reading|A case of S-CAP involved either any subject who was referred to have a CXR performed as part of the clinical assessment of a febrile syndrome or an acute respiratory infection (ARI), or a hospitalized child who had a CXR performed within 2 days prior to, or within the first 3 days after hospital admission, as part of the clinical assessment of a febrile syndrome or an ARI. CRP cut-off values applied for this outcome measure were 40 milligrams per liter (mg/L), 80 mg/L, and 120 mg/L.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.||Subjects|||Number
739228|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Community Acquired Pneumoniae (CAP) With Any Abnormal Chest X-ray (CXR)|An “abnormal CXR” was defined as a CXR with either consolidation, pleural effusion and/or abnormal pulmonary alveolar or non-alveolar infiltrates on the digital CXR image. CXR with consolidation was defined as a CXR with a dense, often homogeneous, confluent alveolar infiltrate that could encompass an entire lobe or segment, or a fluffy, mass-like, cloud-like density that erased heart and diaphragm borders (silhouette sign) and that often contained air bronchograms. Pleural effusion was defined as a fluid collecting in the pleural space around the lung, seen radiologically as a dense rim (the same density as the chest-wall muscles) interposed between the lung and the ribs.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.||Subjects|||Number
739229|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Suspected Community Acquired Pneumoniae (CAP) (S-CAP)|An episode of S-CAP involved either any subject who was referred to have a chest X-ray (CXR) performed as part of the clinical assessment of a febrile syndrome or an acute respiratory infection (ARI), or a hospitalized child who had a CXR performed within 2 days prior to, or within the first 3 days after hospital admission, as part of the clinical assessment of a febrile syndrome or an ARI.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.||Subjects|||Number
739230|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Bacterial Community Acquired Pneumoniae (B-CAP) With Positive Respiratory Viral Test (RVT).||Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.||Subjects|||Number
739231|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Community Acquired Pneumoniae (CAP) With Any Abnormal CXR With Positive Respiratory Viral Test (RVT)|An “abnormal CXR” was defined as a CXR with either consolidation, pleural effusion and/or abnormal pulmonary alveolar or non-alveolar infiltrates on the digital CXR image. CXR with consolidation was defined as a CXR with a dense, often homogeneous, confluent alveolar infiltrate that could encompass an entire lobe or segment, or a fluffy, mass-like, cloud-like density that erased heart and diaphragm borders (silhouette sign) and that often contained air bronchograms. Pleural effusion was defined as a fluid collecting in the pleural space around the lung, seen radiologically as a dense rim (the same density as the chest-wall muscles) interposed between the lung and the ribs.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.||Subjects|||Number
739232|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Community Acquired Pneumoniae (CAP) With Alveolar Consolidation or Pleural Effusion on the Chest X-ray (CXR) (C-CAP) With Positive Respiratory Viral Test (RVT)|A CXR with consolidation was defined as a CXR with a dense, often homogeneous, confluent alveolar infiltrate that could encompass an entire lobe or segment, or a fluffy, mass-like, cloud-like density that erased heart and diaphragm borders (silhouette sign) and that often contained air bronchograms. Pleural effusion was defined as a fluid collecting in the pleural space around the lung, seen radiologically as a dense rim (the same density as the chest-wall muscles) interposed between the lung and the ribs.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.||Subjects|||Number
739233|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Bacteriologically Confirmed Acute Otitis Media (AOM) (B-AOM) Due to Other AOM Pathogens, in the Panama Subset|Other pathogens assessed included among others Moraxella catarrhalis, Group A streptococci, and Staphyloccus aureus. The Panama Subset contained all subjects enrolled in Panama.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.||Subjects|||Number
739234|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Bacteriologically Confirmed Acute Otitis Media (AOM) (B-AOM) Due to Non-typeable Haemophilus Influenzae (H. Influenzae), in the Panama Subset|The Panama Subset contained all subjects enrolled in Panama|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.||Subjects|||Number
739235|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Bacteriologically Confirmed Acute Otitis Media (AOM) (B-AOM) Due to Haemophilus Influenzae (H. Influenzae), in the Panama Subset|The Panama Subset contained all subjects enrolled in Panama.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.||Subjects|||Number
739236|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Bacteriologically Confirmed Acute Otitis Media (AOM) (B-AOM) Due to Other Pneumococcal Serotypes, in the Panama Subset.|Other pneumococcal serotypes were defined for this outcome measures as non-Streptococcus pneumoniae vaccine and cross-reactive serotypes. The Panama Subset contained all subjects enrolled in Panama.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.||Subjects|||Number
739295|NCT00467519|Other Pre-specified|Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination|Solicited Injection Site Reactions: Pain, erythema/redness, swelling, increased left limb circumference, and increased right limb circumference. Solicited Systemic Reactions: Fever (temperature), headache, malaise, and myalgia.|Days 0 to 7 post-vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.||Participants|||Number
739237|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Bacteriologically Confirmed Acute Otitis Media (AOM) (B-AOM) Due to Streptococcus Pneumoniae (S. pn.) Cross-reactive Serotypes, in the Panama Subset.|The S. pn. cross-reactive serotypes assessed for this outcome measure were the serotypes 6A, 18B, 19A and 23A. The Panama Subset contained all subjects enrolled in Panama.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.||Subjects|||Number
739238|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Bacteriologically Confirmed Acute Otitis Media (AOM) (B-AOM) Due to Streptococcus Pneumoniae (S. pn.) Vaccine Serotypes, in the Panama Subset|The 10 pneumococcal S. pneumoniae vaccine serotypes assessed for this outcome measure were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The Panama Subset contained all subjects enrolled in Panama.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.||Subjects|||Number
739239|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Bacteriologically Confirmed Acute Otitis Media (AOM) (B-AOM) Due to Any Bacterial Pathogen, in the Panama Subset|The Panama Subset contained all subjects enrolled in Panama.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.||Subjects|||Number
739240|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Community Acquired Pneumoniae (CAP) With Alveolar Consolidation or Pleural Effusion on the Chest X-ray (CXR) (C-CAP)|CXR alveolar consolidation was defined as CXR with a dense, often homogeneous, confluent alveolar infiltrate that could encompass an entire lobe or segment, or a fluffy, mass-like, cloud-like density that erased heart and diaphragm borders (silhouette sign) and that often contained air bronchograms. CXR pleural effusion was defined as a fluid collecting in the pleural space around the lung, seen radiologically as a dense rim (the same density as the chest-wall muscles) interposed between the lung and the ribs.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.||Subjects|||Number
739241|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Clinically Confirmed Acute Otitis Media (AOM) (C-AOM), in the Panama Subset|The Panama Subset contained all subjects enrolled in Panama.|Any time from 2 weeks after Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.||Subjects|||Number
739242|NCT00466947|Secondary|Number of Subjects With Solicited General Symptoms Post Booster Vaccination in the Immunogenicity and Tolerability Subset|Assessed symptoms were fever (defined as rectal temperature equal or higher than [>=] 38 degrees Celsius [°C]). irritability/fussiness, drowsiness, and loss of appetite. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|Within the 4-days (Days 0–3) follow-up period following the booster vaccine administration|The analysis was performed on all vaccinated subjects included in the Immunogenicity and Tolerability subset for the booster vaccination.||Subjects|||Number
739243|NCT00466947|Secondary|Number of Subjects With Solicited General Symptoms Post Primary Vaccination in the Immunogenicity and Tolerability Subset|Assessed symptoms were fever (defined as rectal temperature equal or higher than [>=] 38 degrees Celsius [°C]). irritability/fussiness, drowsiness, and loss of appetite. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|Within the 4-days (Days 0–3) follow-up period across the 3 doses of the primary study vaccine administration|The analysis was performed on all vaccinated subjects included in the Immunogenicity and Tolerability subset for the primary vaccination course.||Subjects|||Number
739244|NCT00466947|Secondary|Number of Subjects With Solicited Local Symptoms Post Booster Vaccination in the Immunogenicity and Tolerability Subset, for the Control Group|Assessed symptoms were redness, swelling and pain. The Immunogenicity and Safety Tolerability Subset included 500 subjects coming from Argentina and Panama respectively. This outcome measure concerns solely subjects from the Control Group.|Within the 4-days (Days 0–3) follow-up period following the booster vaccine administration.|The analysis was performed on all vaccinated subjects included in the Immunogenicity and Tolerability subset for the booster vaccination.||Subjects|||Number
739245|NCT00466947|Secondary|Number of Subjects With Solicited Local Symptoms Post Primary Vaccination in the Immunogenicity and Tolerability Subset|Assessed symptoms were redness, swelling and pain. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively. This outcome measure concerns solely subjects from the Control Group.|Within the 4-days (Days 0–3) follow-up period across the 3 doses of the primary study vaccine administration|The analysis was performed on all vaccinated subjects included in the Immunogenicity and Tolerability subset for the primary vaccination course.||Subjects|||Number
739246|NCT00466947|Secondary|Number of Subjects With Solicited Local Symptoms Post Booster Vaccination in the Immunogenicity and Tolerability Subset|Assessed symptoms were redness, swelling and pain. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively. This outcome measure concerns solely subjects from the Synflorix Group.|Within the 4-days (Days 0–3) follow-up period following the booster vaccine administration|The analysis was performed on all vaccinated subjects included in the Immunogenicity and Tolerability subset for the booster vaccination.||Subjects|||Number
739479|NCT00468052|Primary|Duration of Agitation|Cole EA scale 1=calm , 5=unconsolable|on arrival to PACU and for 2 hours postoperatively|||minutes||Standard Deviation|Mean
739248|NCT00466947|Secondary|Number of Subjects With Any Unsolicited Adverse Event (AE), in the Panama Subset|An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. The Panama Subset included all subjects from Panama.|Throughout the study (Month 0 to Month 22-25)|The analysis was performed on all vaccinated subjects included in the Panama subset.||Subjects|||Number
739249|NCT00466947|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Throughout the study (Month 0 to Month 22-25)|The analysis was performed on all vaccinated subjects whose data were exploited towards analysis of results at the end of the study.||Subjects|||Number
739250|NCT00466947|Primary|Number of Subjects With a First Episode Reported of Bacterial Community Acquired Pneumoniae (B-CAP)|"A B-CAP episode was defined as a radiologically confirmed community acquired pneumoniae (CAP) episode with either alveolar consolidation/pleural effusion on the chest X-ray (CXR) or with non-alveolar infiltrates but with C reactive protein (CRP) higher than or equal to (>=) 40 milligrams per liter (mg/L). The results are presented for data lock point for the primary outcome analysis (31 August 2010), which was performed, as per protocol, when at least 535 first B-CAP episodes were reported from 2 weeks after the third vaccination dose.
After analysis on primary outcome was performed, re-monitoring activities revealed Informed Consent Form issues for some subjects. Therefore, a sensitivity analysis excluding 144 subjects was performed. This analysis confirmed the validity of the results for primary outcome."|Any time from 2 weeks after Dose 3 up to 31 August 2010|Analysis was performed on the Interim ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of 31 August 2010.||Subjects|||Number
739251|NCT00466960|Secondary|Precursor Frequency of Circulating T Lymphocytes Activated Against Foreign Antigens|Correlation of time to progression and change in circulating activated T lymphocytes from baseline to follow-up.|Up to 5 years|||Pearson correlation||95% Confidence Interval|Number
739252|NCT00466960|Secondary|Precursor Frequency of Circulating Activated T Lymphocytes Against Common Ovarian Cancer Tumor Associated Antigens to Measure the Development of Immunity to Anti-tumor Antigens|Correlation of time to progression and change in circulating activated T lymphocytes from baseline to follow-up.|Up to 5 years|||Pearson correlation||95% Confidence Interval|Number
739253|NCT00466960|Secondary|Correlation Between Circulating Dendritic Cell Count and Maturation State With Clinical Response and Response Duration|Baseline median percentages of CD45+ cells made up of myeloid dendritic cells (mDC) and plasmacytoid dendritic cells (pDC) in complete responders (CR) compared to partial and non-responders (PR+NR+SD).|Up to 5 years|||% of CD45+PBMC||Inter-Quartile Range|Median
739254|NCT00466960|Secondary|Correlation Between Circulating Monocytes and Time to Progression|Baseline median percentages of CD45+ cells made up of monocytes in complete responders (CR) compared to partial-responders, non-responders and those with stable disease (PR+NR+SD).|Up to 5 years|||percentage of CD45+ in PBSC||Inter-Quartile Range|Median
739255|NCT00466960|Primary|Response Rate|Number of patients achieving a complete or partial response.|Up to 5 years|||Participants|||Count of Participants
739256|NCT00466960|Primary|Time to Progression|Median time to progression|Up to 5 years|||months||95% Confidence Interval|Median
739257|NCT00467038|Secondary|Group x Time Interaction Amygdala Activity|0 to 12 month difference scores in group x time interaction amygdala activity|Baseline and 12 months|||bold signal units||Standard Deviation|Mean
739258|NCT00467038|Primary|Self-Report of Difficulties in Emotion Regulation (DERS)|"The present study examines DBT treatment effect on emotion regulation in unmedicated outpatients with BPD as measured by changes in the Difficulties in Emotion Regulation Scale. The DERS is a brief, 36-item, self-report questionnaire.
DERS total score ranges from 36- 180. Higher scores reflect higher difficulties in emotion regulation.
The measure yields a total score as well as scores on six scales derived through factor analysis:
1. Nonacceptance of emotional responses, 2. Difficulties engaging in goal directed behavior, 3. Impulse control difficulties, 4. Lack of emotional awareness, 5. Limited access to emotion regulation strategies, 6. Lack of emotional clarity Responses are on a 5-point scale: 1=almost never, 2=sometimes, 3=about half the time, 4=most of the time, 5=almost always"|12 months|22 age- and gender-matched unmedicated BPD and HC participants (11 in each group).||units on a scale||Standard Deviation|Mean
739259|NCT00467051|Secondary|Toxicity as Measured by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events ( CTCAE) Version 4.0|All patients who experience any grade 2 or higher toxicity at any time during the two treatment cycles or who receive at least all required Ifosfamide therapy after enrollment will be considered evaluable for toxicity. The descriptions and grading scales found in the revised NCI CTCAE version 4 will be used.|During and after completion of study treatment||||||
739260|NCT00467051|Primary|Response Rate as Measured by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria|Patients who demonstrate a PR or CR, as defined below, will be considered as responders. RECIST criteria: CR (complete response) = disappearance of all target lesions, PR (partial response) = 30% decrease in the sum of the longest diameter of target lesions, PD (progressive disease) = 20% increase in the sum of the longest diameter of target lesions and SD (stable disease) = small changes that do not meet above criteria.|At baseline (day 1) and after completion of protocol therapy (2 cycles or 42 days)|||participants|||Number
739261|NCT00467077|Secondary|Overall Survival|Estimated using the product-limit method of Kaplan and Meier.|Up to 5 years.|||Months||95% Confidence Interval|Median
739262|NCT00467077|Secondary|Progression-Free Survival|Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Until disease progression, up to 5 years.|||Months||95% Confidence Interval|Median
739264|NCT00467077|Primary|Six-month Progression-free Survival|Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-target lesions|From the date treatment started until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months|||percentage of participants||95% Confidence Interval|Number
739265|NCT00467259|Secondary|Incidence Endometrial Hyperplasia in Naturally Postmenopausal Women With HSDD Using Concomitant Estrogen & Progestin Combined With Those Not Using Estrogen & Progestin Therapy, Year 1|Incidence measured is number of patients with endometrial hyperplasia/number of patients with evaluable biopsies|52 weeks|Subjects with evaluable endometrial biopsies.||# Endometrial Hyperplasia/Evaluable Biop||95% Confidence Interval|Number
739266|NCT00467259|Secondary|Incidence of Endometrial Hyperplasia in Naturally Postmenopausal Women With HSDD Using Concomitant Estrogen and Progestin, Year 1|Incidence measured is number of patients with endometrial hyperplasia/number of patients with evaluable biopsies|52 weeks|Subjects with evaluable endometrial biopsies.||# Endometrial Hyperplasia/Evaluable Biop||95% Confidence Interval|Number
739267|NCT00467259|Primary|Incidence of Endometrial Hyperplasia in Naturally Postmenopausal Women With Hypoactive Sexual Desire Disorder (HSDD) Not Using Concomitant Estrogen and Progestin, Year 1|Incidence measured is number of patients with endometrial hyperplasia/number of patients with evaluable biopsies|52 weeks|Subjects with evaluable endometrial biopsies.||# Endometrial Hyperplasia/Evaluable Biop||95% Confidence Interval|Number
739268|NCT00467285|Primary|Changes in BMD 0.33 Radius|% change in BMD at 6 month follow up compared to baseline|6 months|||% change in BMD||Standard Deviation|Mean
739269|NCT00467285|Primary|Changes in BMD AP Spine|% change in BMD at 6 month follow up compared to baseline|6 months|||% change in BMD||Standard Deviation|Mean
739270|NCT00467285|Secondary|Changes in CTx at Follow up|% change in the levels of CTx at 6 months follow up compared to baseline|6 months|||% change||Standard Deviation|Mean
739271|NCT00467285|Primary|Changes in BMD Total Hip|% change at 6 month follow up compared to baseline|6 months|||% change in BMD||Standard Deviation|Mean
739272|NCT00467285|Secondary|Osteocalcin|% change at 6 month follow up compared to baseline|6 months|||% change||Standard Deviation|Mean
739273|NCT00467285|Secondary|CTx|% Change in bone turnover markers at 6 month follow up compared to baseline|6 months|||pg/mL||Standard Deviation|Mean
739274|NCT00467285|Primary|Changes in BMD at Femoral Neck|% changes in BMD ( BMD at Lumbar spine, femoral neck and 0.33 radius) and bone turn over markers in subjects with diabetes on pioglitazone compared to those who are not on Pioglitazone|6 months|28 subjects on pioglitazone and 64 subjects not on pioglitazone||percentage of change in BMD||Standard Deviation|Mean
739275|NCT00467363|Secondary|Abruption|Partial or complete abruption (ie, premature separation of the placenta)|until delivery|||participants|||Number
739276|NCT00467363|Secondary|Fetal Intolerance of Labor||until delivery|No data were collected for this Outcome Measure.|||||
739277|NCT00467363|Secondary|Abnormal Fetal Testing||8 weeks|No data were collected for this Outcome Measure.|||||
739278|NCT00467363|Secondary|Preterm Birth||until delivery|||infants|||Number
739279|NCT00467363|Secondary|Small for Gestational Age Infant|birthweight|until delivery|||grams||Standard Deviation|Mean
739280|NCT00467363|Secondary|Preeclampsia||until delivery|||participants|||Number
739281|NCT00467363|Secondary|Molar Pregnancy||8 weeks|||pregnancy|||Number
739282|NCT00467363|Secondary|Ectopic Pregnancy||within 6 weeks|||pregnancy|||Number
739283|NCT00467363|Secondary|Stillbirth||40 weeks|||participants|||Number
739284|NCT00467363|Secondary|Fetal Pregnancy Loss||until 40 weeks|||pregnancy|||Number
739285|NCT00467363|Secondary|Pregnancy Losses Occurring Less Than 10 Weeks|Includes preembryonic and embryonic losses (exclusive of implantation failures)|less than 10-weeks|||pregnancy|||Number
739286|NCT00467363|Secondary|Early Pregnancy Loss (EPL)|Implantation failures|8 weeks|||pregnancy|||Number
739287|NCT00467363|Secondary|Clinically Recognized Pregnancy||8-weeks|||pregnancy|||Number
739288|NCT00467363|Secondary|hCG Recognized Pregnancy||within 8-weeks of gestation|||pregnancy|||Number
739289|NCT00467363|Primary|Live Birth|Live birth was obtained prospectively by maternal report and abstraction from medical records by trained staff .|after delivery|Analyses were based on the intention-to-treat principle (excluding participants lost to follow-up).||livebirths|||Number
739290|NCT00467389|Secondary|Cocaine Pharmacokinetics|Area-Under-the-Curve for Plasma Concentration|0 to 8 hours|||ng-hr/ml||Standard Error|Mean
739291|NCT00467389|Secondary|Cocaine Subjective Effects|Cocaine Induced 'High' by VAS (visual analogue scale, between 3 and 30 minutes after intravenous dosing, in mm). VAS results ranged from 0 (minimum effect) to 100 (maximum effect).|3 to 30 minutes|||mm||Standard Error|Mean
739292|NCT00467389|Primary|Cocaine Safety in Subjects Receiving Donepezil|Patients evaluated for clinical and laboratory adverse events|Two weeks|All participants included||Participants with an Adverse Event|||Number
739293|NCT00467519|Primary|Geometric Mean Titers (GMTs) at Baseline and 30 Days Post Vaccination for Pertussis|Pre- and post-vaccination GMTs and their 95% confidence intervals for pertussis toxoid (PT), pertussis filamentous hemagglutinin (FHA), pertussis pertactin (PRN), and pertussis Fimbriae types 2 and 3 (FIM), were determined by enzyme-linked immunosorbent assay (ELISA).|Pre-dose and 30 Days Post-vaccination|Geometric mean titers were assessed in the per-protocol population.||EU/mL||95% Confidence Interval|Geometric Mean
739294|NCT00467519|Primary|Percentage of Participants Who Demonstrated Booster Response at 30 Days Post-Vaccination for Diphtheria and Tetanus|"Booster response was defined as post titer ≥ 0.4 IU/mL and pre titer < 0.1 IU/mL, or Post/Pre titer ≥ 4 increase and pre-titer ≥ 0.1 IU/mL but < 2 IU/mL, or Post/Pre titer ≥ 2 increase and pre-titer ≥ 2 IU/mL.
Post-vaccination titers for Diphtheria was determined by neutralization assay; tetanus titers was determined by an enzyme-linked immunosorbent assay (ELISA)."|30 Days post-vaccination|Diphtheria and tetanus antibody booster response were analysed in all enrolled and vaccinated participants, per-protocol population.||Percentage of Participants|||Number
739296|NCT00467519|Primary|Percentage of Participants Who Demonstrated Booster Response at 30 Days Post-Vaccination for Pertussis|"Booster response was defined as post titer ≥ 0.4 IU/mL and pre-titer < 0.1 IU/mL, or Post/Pre titer ≥ 4 increase and pre titer ≥ 0.1 IU/mL but < 2 IU/mL, or Post/Pre titer ≥ 2 increase and pre-titer ≥ 2 IU/mL
Post-vaccination titers for pertussis toxoid (PT), pertussis filamentous hemagglutinin (FHA), pertussis pertactin (PRN), and pertussis Fimbriae types 2 and 3 (FIM), were determined by enzyme-linked immunosorbent assay (ELISA)."|30 Days post-vaccination|Pertussis antibody booster response analysis was in all enrolled and vaccinated participants in the per-protocol population.||Percentage of Participants|||Number
739297|NCT00467519|Primary|Percentage of Participants Who Achieved Serothreshold at Baseline and 30 Days Post-vaccination for Diphtheria and Tetanus at Level ≥ 1.0 IU/mL|"Serothreshold rate at level ≥ 1.0 IU/mL was defined as antibody concentrations ≥ 1.0 IU/mL.
Diphtheria titers were determined by toxin neutralization assay; tetanus titers were determined by enzyme-linked immunosorbent assay (ELISA)."|Pre-dose and 30 days post-vaccination|Diphtheria and tetanus antibody analysis was in all enrolled and vaccinated participants in the per-protocol population.||Percentage of Participants|||Number
739298|NCT00467519|Primary|Percentage of Participants Who Achieved Seroprotection at Baseline and 30 Days Post-vaccination for Diphtheria and Tetanus at ≥ 0.1 IU/mL Level|"Seroprotection rate at level ≥ 0.1 IU/mL was defined as antibody concentrations ≥ 0.1 IU/mL.
Diphtheria titers were determined by toxin neutralization assay; tetanus titers were determined by enzyme-linked immunosorbent assay (ELISA)."|Pre-dose and 30 days post-vaccination|Diphtheria and tetanus antibody analysis was in all enrolled and vaccinated participants in the per-protocol population.||Percentage of Participants|||Number
739299|NCT00467558|Primary|Yale Brown Obsessive Compulsive Scale Modified for Compulsive Sexual Behavior (YBOCS)|The YBOCS is a reliable and valid, 10-item, clinician-administered scale that rates buying symptoms within the last seven days, on a severity scale from 0 to 4 for each item (total scores range from 0 to 40 with higher scores reflecting greater illness severity).|Assessed at each visit (every two weeks) until participation in the study was done (Week 8)|Reported scores are Mean and standard deviation for Subjects last visit (Week 8 or last-observation carried forward).||units on a scale||Standard Deviation|Mean
739300|NCT00467558|Secondary|Clinical Global Impression Scale - Severity|The CGI consists of two reliable and valid 7-item Likert scales used to assess severity in clinical symptoms. The scale ranges from 1 = “very much improved” to 7 = “very much worse.” The CGI severity scale was used at each visit and ranges from 1 = “not ill at all” to 7 = “among the most extremely ill.”|Assessed at each visit (every two weeks) until participation in the study was done (Week 8)|Reported scores are Mean and standard deviation for Subjects last visit (Week 8 or last-observation carried forward).||units on a scale||Standard Deviation|Mean
739301|NCT00467584|Primary|Modified Fatigue Impact Scale Score|The Modified Fatigue Impact Scale is a list of 21 statements describing how fatigue may affect a person's functioning. Answers ranging from 0 (Never) to 4 (Almost always) were provided by the study subjects for the prior 4 week period. A total score was tallied from a possible 0 (no fatigue impact) to 84 (almost always impacted by fatigue). A lower total score indicates less fatigue-related impact while a higher total score indicates greater fatigue-related impact on a subject's functioning.|Baseline, 8 weeks|62 patients were randomized; of these, 6 did not receive the intervention and an additional 4 discontinued without providing followup data. Therefore 52 were included in the analysis. The Wk 4 MFIS score was used if the subject withdrew prior to Wk 8. 1 subject each in the High Dose and Placebo groups provided MFIS data at Wk 4 but not Wk 8.||units on a scale||Standard Deviation|Mean
739302|NCT00467597|Primary|Gaitmat Stance Measurements (AUC)|Gaitmat stance measurements were measured every half hour throughout an 8 hour period. Area under the curve was computed using the trapezoidal method for root mean squared velocity in the anterior-posterior direction. Each subject's unique baseline was used by computing the mean of the test-retest period measured at 08:00 am.|Every 1/2 hour during an 8 hour period.|||Root Mean Square of Velocity*Minutes||Standard Deviation|Mean
739303|NCT00467610|Secondary|Hematological Improvement Rate at Week 8 as Defined by the IWG 2000 Criteria for Response Assessment, 2000 Version||At 8 weeks from start of therapy|||participants|||Number
739304|NCT00467610|Primary|Response Rate ( CR+PR) at Week 8, Based on the IWG Criteria for Response Assessment ( 2000 Version)|"Complete response(CR): <5% blasts in the bone marrow,with normal maturation of all cell lines, Hemoglobin >11 g/dL, neutrophils>1500/mm3 platelets>100,000/mm3.
Partial response (PR): >50% decrease in blasts, or less advanced IPSS than pretreatment value, same hematological parameters as in CR.
Stable disease (SD): No evidence of disease progression in bone marrow, stable peripheral blood counts failure: Increase in bone marrow blast percentage, progression to more advanced IPSS than pretreatment and worsening of cytopenias.
(Cheson, 2000)"|After 8 weeks of therapy with panhematin|||Participants|||Number
739305|NCT00467610|Secondary|Number of Patients Demonstrating Hematological Improvement to Panhematin® at Week 4.|"Hematological improvement (HI)
Major:
HI-Erythroid:>2 g/dL rise in hemoglobin, or transfusion independence HI-Neutrophil: Absolute increase of >500/mm3, or >100% increase HI-Platelet: Absolute increase of >30,000, or transfusion independence
Minor:
HI-Erythroid:1 to 2 g/dL increase in hemoglobin or 50% decrease in transfusion dependence.
HI-P: For patients with pretreatment platelet count < 100,000/mm3, ≥ 50% increase with a net increase > 10,000/mm3 but < 30,000/mm3.
HI-N: For patients with pretreatment ANC < 1500/mm3, ≥ 100% increase, but < 500/mm3 increase."|4 weeks after initiation of treatment with Panhematin|||participants|||Number
739306|NCT00467610|Primary|Safety and Tolerability of Panhematin®.|Number of patients with no adverse events.|participants were followed during therapy with panhematin, and up to six months post completion of therapy, average of 8 months.|||participants|||Number
739307|NCT00467649|Other Pre-specified|Hypoglycemia Adverse Events|"MILD: patient reported symptoms consistent with hypoglycemia that may or may not have been documented by glucose monitoring at the time of symptoms. Symptoms did not greatly interrupt or interfere with the patients daily activities. Symptoms dissipated spontaneously or upon eating.
MODERATE: Patient reported symptoms consistent with hypoglycemia that may or may not have been documented by glucose monitoring at the time of symptoms. Symptoms interrupted or interfered with the patients daily activities and required immediate self treatment (e.g. carbohydrate ingestion).
SEVERE: Patient required the assistance of another individual (including aid in ingestion of oral carbohydrate): and/or required the administration of glucagon injection, intravenous glucose, or other medical intervention."|36 weeks|||participants|||Number
739312|NCT00467649|Secondary|Change in Waist Circumference From Baseline at Week 24|Baseline values are presented in the Baseline Characteristics section|From Baseline to Week 24|Phase 1 Intent-to-Treat LOCF. LOCF: If a treated patient has missing result value at week 24, then last observed value before week 24 and after baseline is carried forward to impute the week 24 value.||cm||Standard Error|Least Squares Mean
739313|NCT00467649|Secondary|Change in Body Weight From Baseline at Week 24|Baseline values are presented in the Baseline Characteristics section|From Baseline to Week 24|Phase 1 Intent-to-Treat LOCF. LOCF: If a treated patient has missing result value at week 24, then last observed value before week 24 and after baseline is carried forward to impute the week 24 value.||kg||Standard Error|Least Squares Mean
739314|NCT00467649|Secondary|Change in HbA1c From Baseline at Week 24|Baseline values are presented in the Baseline Characteristics section|From Baseline to Week 24|Phase 1 Intent-to-Treat LOCF. LOCF: If a treated patient has missing result value at week 24, then last observed value before week 24 and after baseline is carried forward to impute the week 24 value.||Percent||Standard Error|Least Squares Mean
739315|NCT00467649|Secondary|Percentage of Patients With a Severe Hypoglycemia Adverse Event|This is a component of the primary endpoint.|24 Weeks|Phase 1 Intent-to-Treat||Percent|||Number
739316|NCT00467649|Secondary|Percentage of Patients With no Weight Gain at Week 24|This is a component of the primary endpoint|24 Weeks|Phase 1 Intent-to-Treat||Percent|||Number
739317|NCT00467649|Secondary|Percentage of Patients Achieving HbA1c <=7% at Week 24|This is a component of the primary endpoint|24 Weeks|Phase 1 Intent-to-Treat||Percent|||Number
739318|NCT00467649|Primary|The Percentage of Patients Achieving HbA1c <=7% at Week 24 With no Gain in Body Weight From Baseline and no Incidence of Severe Hypoglycemia|A severe hypoglycemia is defined as an event during which the patient required the assistance of another individual (including aid in ingestion of oral carbohydrate); and/or required the administration of glucagon injection, intravenous glucose, or other medical intervention.|24 Weeks|Phase 1 Intent-to-Treat LOCF. LOCF: If a treated patient has missing result value at week 24, then last observed value before week 24 and after baseline is carried forward to impute the week 24 value.||Percent|||Number
739319|NCT00467740|Secondary|Laboratory Testing: Average Change From Baseline of Potassium|Laboratory testing: Average change from baseline of potassium measured on test-days. Pre−dose value on test day 1 is the baseline value.|Baseline and 29 days|Treated Set||mmol/L||Inter-Quartile Range|Geometric Mean
739320|NCT00467740|Secondary|Clinical Relevant Abnormalities for Vital Signs, ECG and Physical Examination|Clinical relevant abnormalities for vital signs, ECG and physical examination. Any new or clinically relevant worsening of baseline conditions was reported as adverse events.|4 weeks|Treated set||participants|||Number
739321|NCT00467740|Secondary|Total Score in Asthma Control Questionnaire After 4 Weeks|Adequacy of asthma control was assessed using a scale of: 0=totally controlled, to 6=Severely uncontrolled.|4 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||units on a scale||Standard Error|Least Squares Mean
739322|NCT00467740|Secondary|Time From Dosing to the Maximum Concentration at Steady State (Tmax,ss)|tmax,ss represents the time from dosing to maximum concentration of olodaterol and olodaterol glucuronide (a metabolite of olodaterol) in plasma at steady state.|30 minutes (mins) before drug administration and 5mins, 10mins, 20mins, 40mins, 1 hour (h), 3h and 6h after drug administration|All evaluable patients were included in the pharmacokinetic (PK) analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of PK parameters or had insufficient data.||hours||Full Range|Median
739323|NCT00467740|Secondary|Maximum Concentration at Steady State (Cmax,ss)|Cmax,ss represents the maximum concentration of olodaterol and olodaterol glucuronide (a metabolite of olodaterol) in plasma at steady state.|30 minutes (mins) before drug administration and 5mins, 10mins, 20mins, 40mins, 1 hour (h), 3h and 6h after drug administration|All evaluable patients were included in the pharmacokinetic (PK) analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of PK parameters or had insufficient data.||Picogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
739324|NCT00467740|Secondary|Area Under Curve From 0 to 24 Hours at Steady State (AUC0-24,ss)|AUC0-24,ss represents the area under the concentration curve of olodaterol and olodaterol glucuronide (a metabolite of olodaterol) in plasma from 0 to time t=24 at steady state.|30 minutes (mins) before drug administration and 5mins, 10mins, 20mins, 40mins, 1 hour (h), 3h and 6h after drug administration|All evaluable patients were included in the pharmacokinetic (PK) analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of PK parameters or had insufficient data.||Picogram*hours/milliliter||Geometric Coefficient of Variation|Geometric Mean
739325|NCT00467740|Secondary|Area Under Curve From 0 to 6 Hours at Steady State (AUC0-6,ss)|AUC0-6,ss represents the area under the concentration curve of olodaterol and olodaterol glucuronide (a metabolite of olodaterol) in plasma from 0 to time t=6 at steady state.|30 minutes (mins) before drug administration and 5mins, 10mins, 20mins, 40mins, 1 hour (h), 3h and 6h after drug administration|All evaluable patients were included in the pharmacokinetic (PK) analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of PK parameters or had insufficient data.||Picogram*hours/milliliter||Geometric Coefficient of Variation|Geometric Mean
739326|NCT00467740|Secondary|Area Under Curve From 0 to 3 Hours at Steady State (AUC0-3,ss)|AUC0-3,ss represents the area under the concentration curve of olodaterol and olodaterol glucuronide (a metabolite of olodaterol) in plasma from 0 to time t=3 at steady state.|30 minutes (mins) before drug administration and 5mins, 10mins, 20mins, 40mins, 1 hour (h), 3h and 6h after drug administration|All evaluable patients were included in the pharmacokinetic (PK) analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of PK parameters or had insufficient data.||Picogram*hours/milliliter||Geometric Coefficient of Variation|Geometric Mean
739327|NCT00467740|Secondary|Time From Dosing to the Maximum Concentration (Tmax)|tmax represents the time from dosing to maximum concentration of olodaterol and olodaterol glucuronide (a metabolite of olodaterol) in plasma.|30 minutes (mins) before drug administration and 5mins, 10mins, 20mins, 40mins, 1 hour (h) and 3h after drug administration|All evaluable patients were included in the pharmacokinetic (PK) analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of PK parameters or had insufficient data.||hours||Full Range|Median
739328|NCT00467740|Secondary|Maximum Concentration (Cmax)|Cmax represents the maximum concentration of olodaterol and olodaterol glucuronide (a metabolite of olodaterol) in plasma.|30 minutes (mins) before drug administration and 5mins, 10mins, 20mins, 40mins, 1 hour (h) and 3h after drug administration|All evaluable patients were included in the pharmacokinetic (PK) analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of PK parameters or had insufficient data.||Picogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
739329|NCT00467740|Secondary|Area Under Curve From 0 to 3 Hours (AUC0-3)|AUC0-3 represents the area under the concentration curve of olodaterol and olodaterol glucuronide (a metabolite of olodaterol) in plasma from 0 to time t=3|30 minutes (mins) before drug administration and 5mins, 10mins, 20mins, 40mins, 1 hour (h) and 3h after drug administration|All evaluable patients were included in the pharmacokinetic (PK) analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of PK parameters or had insufficient data.||Picogram*hours/milliliter||Geometric Coefficient of Variation|Geometric Mean
739330|NCT00467740|Secondary|Weekly Mean Number of Occasions of Rescue Therapy After 4 Weeks|Weekly mean number of occasions of rescue therapy used per day (prn salbutamol [albuterol]) as assessed by the e-Diary (e-Diary incorporated in AM2+).|4 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Number of Puffs||Standard Error|Least Squares Mean
739331|NCT00467740|Secondary|PEFR Variability After 4 Weeks|PEFR variability represents the absolute difference between the highest morning PEFR value and the highest evening PEFR value of 1 day, divided by the arithmetic mean of these 2 PEFR values and expressed as a percent, weekly means.|4 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||percentage of PEFR||Standard Error|Least Squares Mean
739332|NCT00467740|Secondary|Weekly Mean Evening PEFR After 4 Weeks|Response was defined as change from baseline. Baseline PEFR was defined as the mean of the evening PEFR measurements obtained during the week just prior to first dose of randomized treatment.|Baseline and 4 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter/minute||Standard Error|Least Squares Mean
739333|NCT00467740|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 6-12 h (AUC 6-12h) Response at Week 4|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. FEV1 AUC 6-12h was calculated from 6-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 hour (h) prior to dose on first day of randomized treatment (baseline) and 1h, 3h, 6h, 9h, 12h relative to dose at Week 4|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
739334|NCT00467740|Secondary|Peak FVC (0-3h) Response After 4 Weeks|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to 30 min, 1 h, 2 h, and 3 h relative to dose after 4 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
739335|NCT00467740|Secondary|Peak FVC (0-3h) Response After 2 Weeks|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
739336|NCT00467740|Secondary|Peak FVC (0-3h) Response After 1 Week|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to 30 min, 1 h, 2 h, and 3 h relative to dose after 1 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
739337|NCT00467740|Secondary|Peak FVC (0-3h) Response At Day 1|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to 30 min, 1 h, 2 h, and 3 h relative to dose after 1 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
739338|NCT00467740|Secondary|Peak FEV1 (0-3h) Response After 4 Weeks|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to 30 min, 1 h, 2 h, and 3 h relative to dose after 4 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
739339|NCT00467740|Secondary|Peak FEV1 (0-3h) Response After 2 Weeks|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
739340|NCT00467740|Secondary|Peak FEV1 (0-3h) Response After 1 Week|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to 30 min, 1 h, 2 h, and 3 h relative to dose after 1 week|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
739341|NCT00467740|Secondary|Peak FEV1 (0-3h) Response At Day 1|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to 30 min, 1 h, 2 h, and 3 h relative to dose at day 1|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
739342|NCT00467740|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response at Week 4|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and 30 min, 1h, 2h, 3h relative to dose at Week 4|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
739343|NCT00467740|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response at Week 2|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and 30 min, 1h, 2h, 3h relative to dose at Week 2|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
739344|NCT00467740|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response at Week 1|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and 30 min, 1h, 2h, 3h relative to dose at Week 1|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
739345|NCT00467740|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response at Day 1|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and 30 min, 1h, 2h, 3h relative to dose at Day 1|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
739346|NCT00467740|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-6 h (AUC 0-6h) Response at Week 4|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. FVC AUC 0-6h was calculated from 0-6 hours post-dose using the trapezoidal rule, divided by the observation time (6h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and 30 min, 1h, 2h, 3h, 4h, 5h, 6h relative to dose at Week 4|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
739347|NCT00467740|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-6 h (AUC 0-6h) Response at Week 4|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. FEV1 AUC 0-6h was calculated from 0-6 hours post-dose using the trapezoidal rule, divided by the observation time (6h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and 30 min, 1h, 2h, 3h, 4h, 5h, 6h relative to dose at Week 4|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
739348|NCT00467740|Secondary|Trough FVC Response After 4 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation at the end of the dosing interval.|Baseline and 4 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
739349|NCT00467740|Secondary|Trough FVC Response After 2 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation at the end of the dosing interval.|Baseline and 2 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
739366|NCT00467779|Secondary|Stage 2A: Tmax of Cobimetinib at Steady State|Tmax is defined as the time to reach Cmax during stage 2A in steady state.|Stage 2A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 14, 24 hours post Cycle 1 Day 14 dose (Cycle 1 Day 15), and between Cycle 1 Days 26-28|Safety population; Stage 2A participants only. Number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Median
739350|NCT00467740|Secondary|Trough FVC Response After 1 Week|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation at the end of the dosing interval.|Baseline and 1 week|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
739351|NCT00467740|Secondary|Trough FEV1 Response After 2 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation at the end of the dosing interval.|Baseline and 2 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
739352|NCT00467740|Secondary|Trough FEV1 Response After 1 Week|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation at the end of the dosing interval.|Baseline and 1 week|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
739353|NCT00467740|Secondary|Weekly Mean Pre-dose Morning PEFR After 4 Weeks|Response was defined as change from baseline. Baseline peak expiratory flow response (PEFR) was defined as the mean of the morning PEFR measurements obtained during the week just prior to first dose of randomized treatment.|Baseline and 4 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter/minute||Standard Error|Least Squares Mean
739354|NCT00467740|Primary|Trough FEV1 Response After 4 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation at the end of the dosing interval.|Baseline and 4 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
739355|NCT00467753|Primary|Autism Diagnostic Observation Schedule||Evaluated during Baseline and Termination||||||
739356|NCT00467753|Primary|Clinical Global Impression Improvement Scale||Once a week||||||
739357|NCT00467753|Primary|Aberrant Behavior Checklist||Bi weekly||||||
739358|NCT00467753|Primary|Vineland Adaptive Behavior Scales||Evaluated during Baseline and Termination||||||
739359|NCT00467779|Secondary|Stage III: AUC0-inf of Midazolam|AUC0-inf is the AUC from time 0 to infinity and was calculated both in the presence (Cycle 1 Day 15) and absence (Cycle 1 Day 1) of cobimetinib.|Stage III: Predose, 0.5, 1, 1.5, 2, 4, 6, 8, and 24 hours after dextromethorphan administration on Days 1 and 15 of Cycle 1|Safety population; Stage 3 participants only. n = number of participants analyzed for specified category. Number of participants analyzed = participants who were evaluable for this outcome.||h*ng/mL||Standard Deviation|Geometric Mean
739360|NCT00467779|Secondary|Stage III: AUC0-24 of Midazolam|AUC0-24 is the area under the plasma drug concentration curve over a 24-hour sampling interval and was calculated both in the presence (Cycle 1 Day 15) and absence (CXycle 1 Day 1) of cobimetinib.|Stage III: Predose, 0.5, 1, 1.5, 2, 4, 6, 8, and 24 hours after dextromethorphan administration on Days 1 and 15 of Cycle 1|Safety population; Stage 3 participants only. n = number of participants analyzed for specified category. Number of participants analyzed = participants who were evaluable for this outcome.||h*ng/mL||Standard Deviation|Geometric Mean
739361|NCT00467779|Secondary|Stage III: Cmax of Midazolam|Cmax is the maximum observed plasma concentration and was calculated both in the presence (Cycle 1 Day 15) and absence (Cycle 1 Day 1) of cobimetinib.|Stage III: Predose, 0.5, 1, 1.5, 2, 4, 6, 8, and 24 hours after dextromethorphan administration on Days 1 and 15 of Cycle 1|Safety population; Stage 3 participants only. n = number of participants analyzed for specified category. Number of participants analyzed = participants who were evaluable for this outcome.||ng/mL||Standard Deviation|Geometric Mean
739362|NCT00467779|Secondary|Stage III: AUC 0-inf of Dextromethorphan|AUC0-inf is AUC from time 0 to infinity and was calculated both in presence Cycle 1 Day 15) and absence (Cycle 1 Day 1) of cobimetinib.|Stage III: Predose, 0.5, 1, 1.5, 2, 4, 6, 8, and 24 hours after dextromethorphan administration on Days 1 and 15 of Cycle 1|Safety population; Stage 3 participants only. n = number of participants analyzed for specified category. Number of participants analyzed = participants who were evaluable for this outcome.||h*ng/mL||Standard Deviation|Geometric Mean
739363|NCT00467779|Secondary|Stage III: AUC 0-24 of Dextromethorphan|AUC0-24 is the area under the plasma drug concentration curve over a 24-hour sampling interval and was determined both in presence (Cycle 1 Day 15) and absence (Cycle 1 Day 1) of cobimetinib.|Stage III: Predose, 0.5, 1, 1.5, 2, 4, 6, 8, and 24 hours after dextromethorphan administration on Days 1 and 15 of Cycle 1|Safety population; Stage 3 participants only. n = number of participants analyzed for specified category. Number of participants analyzed = participants who were evaluable for this outcome.||h*ng/mL||Standard Deviation|Geometric Mean
739364|NCT00467779|Secondary|Stage III: Cmax of Dextromethorphan|Cmax is defined as maximum observed plasma concentration and was determined both in the presence (Cycle 1 Day 15) and absence of cobimetinib (Cycle 1 Day 1).|Stage III: Predose, 0.5, 1, 1.5, 2, 4, 6, 8, and 24 hours after dextromethorphan administration on Days 1 and 15 of Cycle 1|Safety population; Stage 3 participants only. n=number of participants analyzed for specified category.||ng/mL||Standard Deviation|Geometric Mean
739365|NCT00467779|Secondary|Stage 2A: Cmax of Cobimetinib at Steady State|Cmax is the maximum plasma concentration achieved following the Day 20 dose in Stage 2A.|Stage 2A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 14, 24 hours post Cycle 1 Day 14 dose (Cycle 1 Day 15), and between Cycle 1 Days 26-28|Analysis population; Stage 2A participants only. Number of participants analyzed = participants who were evaluable for this outcome.||ng/mL||Standard Deviation|Geometric Mean
739883|NCT00459810|Secondary|Measurable Disease Response Rate (Soft Tissue)|Measurable disease response rate by RECIST criteria. Response is defined as at least a 30% decrease in the sum of the longest diameter in measurable lesions (larger than 10mm at baseline).|While receiving study agents (on average, 3 months)|||Participants|||Number
739367|NCT00467779|Secondary|Stage 2A: Half-Life of Cobimetinib at Steady State||Stage 2A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 14, 24 hours post Cycle 1 Day 14 dose (Cycle 1 Day 15), and between Cycle 1 Days 26-28|Safety population; Stage 2A participants only. Number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Median
739368|NCT00467779|Secondary|Stage 2A: Apparent Clearance of Cobimetinib at Steady State|Apparent clearance is the plasma clearance of absorbed drug.|Stage 2A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 14, 24 hours post Cycle 1 Day 14 dose (Cycle 1 Day 15), and between Cycle 1 Days 26-28|Safety population; Stage 2A participants only. Number of participants analyzed = participants who were evaluable for this outcome.||L/hr||Standard Deviation|Mean
739369|NCT00467779|Secondary|Stage 2A: Accumulation Ratio of Cobimetinib at Steady State|Accumulation Ratio AUC0-24 is ratio of AUC on Day 20: Day 1.|Stage 2A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 14, 24 hours post Cycle 1 Day 14 dose (Cycle 1 Day 15), and between Cycle 1 Days 26-28|Safety population; Stage 2A participants only. Number of participants analyzed = participants who were evaluable for this outcome.||ratio||Standard Deviation|Mean
739370|NCT00467779|Secondary|Stage 2A: AUC 0-24/D of Cobimetinib at Steady State|AUC 0-24/D is the dose normalized truncated AUC over a 24-hour sampling interval.|Stage 2A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 14, 24 hours post Cycle 1 Day 14 dose (Cycle 1 Day 15), and between Cycle 1 Days 26-28|Safety population; Stage 2A participants only. Number of participants analyzed = participants who were evaluable for this outcome.||h*ng/mL||Standard Deviation|Mean
739371|NCT00467779|Secondary|Stage 2:Half-Life of Cobimetinib at Steady State|T1/2 half-life of cobimetinib measured over the terminal phase by noncompartmental analysis.|Stage 2: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 21, 24 hours post Cycle 1 Day 21 dose (Cycle 1 Day 22), and between Cycle 1 Days 26-28|Safety population; Stage 2 participants only. Number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Median
739372|NCT00467779|Secondary|Stage 2: Apparent Clearance of Cobimetinib at Steady State|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. Apparent clearance was calculated only for participants who had a quantifiable AUC 0-24 in steady state.|Stage 2: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 21, 24 hours post Cycle 1 Day 21 dose (Cycle 1 Day 22), and between Cycle 1 Days 26-28|Safety population||L/hr||Standard Deviation|Mean
739373|NCT00467779|Secondary|Stage 2: Accumulation Ratio of Cobimetinib at Steady State|Accumulation ratio is AUC0-24 at steady state divided by AUC0-24 on Cycle 1 Day 1. It was calculated only for participants who had a quantifiable AUC 0-24 at steady state.|Stage 2: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 21, 24 hours post Cycle 1 Day 21 dose (Cycle 1 Day 22), and between Cycle 1 Days 26-28|Safety population; Stage 2 participants only. Number of participants analyzed = participants who were evaluable for this outcome.||ratio||Standard Deviation|Geometric Mean
739374|NCT00467779|Secondary|Stage 2: AUC 0-24/D of Cobimetinib at Steady State|AUC 0-24/D is the dose normalized truncated AUC over a 24-hour sampling interval.|Stage 2: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 21, 24 hours post Cycle 1 Day 21 dose (Cycle 1 Day 22), and between Cycle 1 Days 26-28|Safety population; Stage 2 participants only. Number of participants analyzed = participants who were evaluable for this outcome.||h*ng/mL||Standard Deviation|Geometric Mean
739375|NCT00467779|Secondary|Stage 2: AUC 0-24 of Cobimetinib at Steady State|The area under the AUC0-24 for steady state in stage 2 was calculated with the measured data points from the time of administration of cobimetinib up to 24 h after administration by the trapezoidal formula. AUC 0-24 is the truncated AUC over a 24-hour sampling interval. The concentration-time curve is the result of time points of blood sampling and its measured concentration of free cobimetinib in the blood samplings.|Stage 2: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 21, 24 hours post Cycle 1 Day 21 dose (Cycle 1 Day 22), and between Cycle 1 Days 26-28|Safety population; Stage 2 participants only. Number of participants analyzed = participants who were evaluable for this outcome.||h*ng/mL||Standard Deviation|Geometric Mean
739376|NCT00467779|Secondary|Stage 2: Tmax of Cobimetinib at Steady State|Tmax is defined as the time to reach Cmax during stage 2 in steady state.|Stage 2: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 21, 24 hours post Cycle 1 Day 21 dose (Cycle 1 Day 22), and between Cycle 1 Days 26-28|Safety population; Stage 2 participants only; Number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Median
739377|NCT00467779|Secondary|Stage 2: Tmax of Cobimetinib at Cycle 1 Day 1|Tmax is defined as the time to reach Cmax during stage 2 on Day 1.|Stage 2: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 1, pre-dose on Cycle 1 Day 2|Safety population; Stage 2 participants only. Number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Median
739378|NCT00467779|Secondary|Stage 2:AUC 0-24 of Cobimetinib at Cycle 1 Day 1|The area under the AUC0-24 on Day 1 in stage 2 was calculated with the measured data points from the time of administration of cobimetinib up to 24 h after administration by the trapezoidal formula. AUC 0-24 is the truncated AUC over a 24-hour sampling interval. The concentration-time curve is the result of time points of blood sampling and its measured concentration of free cobimetinib in the blood samplings.|Stage 2: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 1, pre-dose on Cycle 1 Day 2|Safety population; Stage 2 participants only. Number of participants analyzed = participants who were evaluable for this outcome.||h*ng/mL||Standard Deviation|Geometric Mean
739379|NCT00467779|Secondary|Stage 2: Cmax of Cobimetinib at Cycle 1 Day 1|Cmax is defined as the maximum plasma concentration achieved after administration of cobimetinib in Stage 2 and was measured in ng/mL.|Stage 2: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 1, pre-dose on Cycle 1 Day 2|Safety population; Stage 2 participants only. Number of participants analyzed = participants who were evaluable for this outcome.||ng/mL||Standard Deviation|Geometric Mean
739380|NCT00467779|Secondary|Stage 1A: Cmax of Cobimetinib at Steady State|Cmax is defined as the maximum plasma concentration achieved after administration of cobimetinib in Stage 1A and was measured in steady state as ng/mL.|Stage 1A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 14, 24, 48, 72 hours post Cycle 1 Day 14 dose (Cycle 1 Day 15, 16, and 17, respectively)|Safety population; Stage 1A participants only. Number of participants analyzed = participants who were evaluable for this outcome.||ng/mL||Standard Deviation|Mean
739381|NCT00467779|Secondary|Stage 1A: AUC 0-24/D of Cobimetinib at Steady State|AUC 0-24/D is the dose normalized truncated AUC over a 24-hour sampling interval.|Stage 1A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 14, 24, 48, 72 hours post Cycle 1 Day 14 dose (Cycle 1 Day 15, 16, and 17, respectively)|Safety population; Stage 1A participants only. Number of participants analyzed = participants who were evaluable for this outcome.||ng*hr/mL/mg||Standard Deviation|Mean
739382|NCT00467779|Secondary|Stage 1A: AUC 0-24 of Cobimetinib at Steady State|The area under the AUC0-24 for steady state in stage 1A was calculated with the measured data points from the time of administration of cobimetinib up to 24 h after administration by the trapezoidal formula. AUC 0-24 is the truncated AUC over a 24-hour sampling interval. The concentration-time curve is the result of time points of blood sampling and its measured concentration of free cobimetinib in the blood samplings.|Stage 1A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 14, 24, 48, 72 hours post Cycle 1 Day 14 dose (Cycle 1 Day 15, 16, and 17, respectively)|Safety population; Stage 1A participants only. Number of participants analyzed = participants who were evaluable for this outcome.||h*ng/mL||Standard Deviation|Mean
739383|NCT00467779|Secondary|Stage 1A: Accumulation Ratio of Cobimetinib at Steady State|Accumulation Ratio: AUC0-24 at steady state divided by AUC0-24 on Cycle 1 Day 1. It was calculated only for participants who had a quantifiable AUC 0-24 at steady state.|Stage 1A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 1, 14, 24, 48, 72 hours post Cycle 1 Day 14 dose (Cycle 1 Day 15, 16, and 17, respectively)|Safety population; Stage 1A participants only. Number of participants analyzed = participants who were evaluable for this outcome.||ratio||Standard Deviation|Mean
739384|NCT00467779|Secondary|Stage 1A: Apparent Clearance of Cobimetinib at Steady State|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. Apparent clearance was calculated only for participants who had a quantifiable AUC 0-24 in steady state.|Stage 1A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 14, 24, 48, 72 hours post Cycle 1 Day 14 dose (Cycle 1 Day 15, 16, and 17, respectively)|Safety population; Stage 1A participants only. Number pf participants analyzed = participants who were evaluable for this outcome.||L/hr||Standard Deviation|Mean
739385|NCT00467779|Secondary|Stage 1A: Tmax of Cobimetinib at Steady State|Tmax is defined as the time to reach Cmax during stage 1A in steady state.|Stage 1A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 14, 24, 48, 72 hours post Cycle 1 Day 14 dose (Cycle 1 Day 15, 16, and 17, respectively)|Safety population; Stage 1A participants only. Number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Median
739386|NCT00467779|Secondary|Stage 1A: t1/2 of Cobimetinib at Steady State|t1/2 is the half-life of cobimetinib measured over the terminal phase by noncompartmental analysis in stage 1A in steady state.|Stage 1A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 14, 24, 48, 72 hours post Cycle 1 Day 14 dose (Cycle 1 Day 15, 16, and 17, respectively)|Safety population; Stage 1A participants only. Number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Median
739387|NCT00467779|Secondary|Stage 1A: AUC 0-24 of Cobimetinib at Cycle 1 Day 1|AUC0-24 for stage 1A was calculated on Day 1 with the measured data points from the time of administration of cobimetinib up to 24 h after administration by the trapezoidal formula. AUC 0-24 is the truncated AUC over a 24-hour sampling interval. The concentration-time curve is the result of time points of blood sampling and its measured concentration of free cobimetinib in the blood samplings.|Stage 1A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 1, pre-dose on Cycle 1 Day 2|Safety population; Stage 1A participants only.||h*ng/mL||Standard Deviation|Mean
739388|NCT00467779|Secondary|Stage 1A: Cmax of Cobimetinib at Cycle 1 Day 1|Cmax is defined as the maximum plasma concentration achieved after administration of cobimetinib on on Day 1 in Stage 1A and was measured as ng/mL.|Stage 1A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 1, pre-dose on Cycle 1 Day 2|Safety population; Stage 1A participants only.||ng/mL||Standard Deviation|Mean
739389|NCT00467779|Secondary|Stage 1A: Tmax of Cobimetinib at Cycle 1 Day 1|Tmax is defined as the time to reach Cmax during stage 1A at Day 1.|Stage 1A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 1, pre-dose on Cycle 1 Day 2|Safety population; Stage 1A participants only.||hours||Full Range|Median
739390|NCT00467779|Secondary|Stage 1: Cmax of Cobimetinib at Steady State|Cmax is defined as the maximum plasma concentration achieved after administration of cobimetinib in Stage 1 and was measured at steady state in ng/mL.|Stage 1: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12-18 hours post-dose on Cycle 1 Day 21, 24, 48, and 72 hours post Cycle 1 Day 21 dose (Cycle 1 Day 22, 23, and 24, respectively)|Safety population; Stage 1 participants only. Number of participants analyzed = participants who were evaluable for this outcome.||ng/mL||Standard Deviation|Mean
739391|NCT00467779|Secondary|Stage 1: Half-Life (t1/2) of Cobimetinib at Steady State|t1/2 is the half-life of cobimetinib measured over the terminal phase by noncompartmental analysis in stage 1 in steady state.|Stage 1: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12-18 hours post-dose on Cycle 1 Day 21, 24, 48, and 72 hours post Cycle 1 Day 21 dose (Cycle 1 Day 22, 23, and 24, respectively)|Safety population; Stage 1 participants only. Number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Median
739392|NCT00467779|Secondary|Stage 1: Apparent Clearance of Cobimetinib at Steady State|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. Apparent clearance was calculated only for participants who had a quantifiable AUC 0-24 in steady state.|Stage 1: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12-18 hours post-dose on Cycle 1 Day 21, 24, 48, and 72 hours post Cycle 1 Day 21 dose (Cycle 1 Day 22, 23, and 24, respectively)|Safety population; Stage 1 participants only. Number of participants analyzed = participants who were evaluable for this outcome.||Liters per hour (L/hr)||Standard Deviation|Mean
739393|NCT00467779|Secondary|Stage 1: Accumulation Ratio of Cobimetinib at Steady State|Accumulation Ratio: AUC0-24 at steady state divided by AUC0-24 on Cycle 1 Day 1. It was calculated only for participants who had a quantifiable AUC 0-24 at steady state.|Stage 1: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12-18 hours post-dose on Cycle 1 Day 1, Day 21, 24, 48, and 72 hours post Cycle 1 Day 21 dose (Cycle 1 Day 22, 23, and 24, respectively)|Safety population; Stage 1 participants only. Number of participants analyzed = participants who were evaluable for this outcome.||ratio||Standard Deviation|Mean
739394|NCT00467779|Secondary|Stage 1: AUC 0-24/D of Cobimetinib at Steady State|AUC 0-24/D is the dose normalized truncated AUC over a 24-hour sampling interval.|Stage 1: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12-18 hours post-dose on Cycle 1 Day 21, 24, 48, and 72 hours post Cycle 1 Day 21 dose (Cycle 1 Day 22, 23, and 24, respectively)|Safety Population; Stage 1 participants only. Number of participants analyzed = participants who were evaluable for this outcome.||ng*hr/mL/mg||Standard Deviation|Mean
739395|NCT00467779|Secondary|Stage 1: AUC 0-24 of Cobimetinib at Steady State|The area under the AUC0-24 for steady state in stage 1 was calculated with the measured data points from the time of administration of cobimetinib up to 24 h after administration by the trapezoidal formula. AUC 0-24 is the truncated AUC over a 24-hour sampling interval. The concentration-time curve is the result of time points of blood sampling and its measured concentration of free cobimetinib in the blood samplings.|Stage 1: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12-18 hours post-dose on Cycle 1 Day 21, 24, 48, and 72 hours post Cycle 1 Day 21 dose (Cycle 1 Day 22, 23, and 24, respectively)|Safety population; Stage 1 participants only. Number of participants analyzed = participants who were evaluable for this outcome.||h*ng/mL||Standard Deviation|Mean
739396|NCT00467779|Secondary|Stage 1: Tmax of Cobimetinib at Steady State|Tmax is defined as the time to reach Cmax during stage 1 in steady state. Steady state was reached when overall intake of cobimetinib was in dynamic equilibrium with its elimination.|Stage 1: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12-18 hours post-dose on Cycle 1 Day 21, 24, 48, and 72 hours post Cycle 1 Day 21 dose (Cycle 1 Day 22, 23, and 24, respectively)|Safety population; Stage 1 participants only. Number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Median
739397|NCT00467779|Primary|Stage 1: Time to Maximum Concentration (Tmax) of Cobimetinib at Day 1, Cycle 1|Tmax is defined as the time to reach Cmax during stage 1 at Day 1 Cycle 1.|Stage 1: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12-18 hours post-dose on Cycle 1 Day 1 and pre-dose on Cycle 1 Day 2|Safety population; Stage 1 participants only.||hours||Full Range|Median
739398|NCT00467779|Primary|Stage 1: Area Under the Plasma Cobimetinib Concentration Curve From Time 0 to 24 Hours (AUC 0-24) Day 1, Cycle 1|The area under the concentrations-time curve (AUC0-24) was calculated with the measured data points from the time of administration of cobimetinib up to 24 h after administration by the trapezoidal formula. AUC 0-24 is the truncated AUC over a 24-hour sampling interval. The concentration-time curve is the result of time points of blood sampling and its measured concentration of free cobimetinib in the blood samples. AUC is measured as hours times nanograms per milliliter (h*ng/mL).|Stage 1: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12-18 hours post-dose on Cycle 1 Day 1, pre-dose on Cycle 1 Day 2|Safety population; Stage 1 participants only.||h*ng/mL||Standard Deviation|Geometric Mean
739399|NCT00467779|Primary|Stage 1: Maximum Observed Concentration (Cmax) of Cobimetinib at Day 1, Cycle 1|Cmax is defined as the maximum plasma concentration achieved after administration of cobimetinib on Day 1, Cycle 1 in Stage 1 and was measured as nanograms per milliliter (ng/mL).|Stage 1: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12-18 hours post-dose on Cycle 1 Day 1 and pre-dose on Cycle 1 Day 2|Safety population; Stage 1 participants only.||ng/mL||Standard Deviation|Geometric Mean
739400|NCT00467779|Primary|Stage 1A: MTD of Cobimetinib in 14/14 Schedule|"AEs were graded according to NCI-CTCAE v3.0. A DLT was the basis for determining MTD in Stage 1A participants. The participants of Stage 1A are dose-escalation cohorts, starting at the MTD of the 21/7 schedule, were treated on a 14/14 schedule to determine the MTD. A DLT was defined as either of the following occurring during the Study Treatment Period:
Occurrence of a drug-related AE that, in the opinion of the CRC, was of potential clinical significance such that further dose escalation would expose participants to risk of irreversible medical harm; Nonhematologic toxicity: Grade 3 or 4 events, including Grade 3 nausea and/or vomiting and/or Grade 3 diarrhea, despite prophylaxis and/or treatment; Hematologic toxicity: Grade 4 thrombocytopenia. Grade 4 neutropenia of more than 4 days’ duration; Grade 4 neutropenia of any duration with fever or documented infection. AEs (Grade 3 or higher) for which a clinical cause unrelated to cobimetinib was evident was not considered DLTs."|Stage 1A: Days 1 to 28 of Cycle 1|Safety population; Stage 1A participants only.||mg|||Number
739401|NCT00467779|Primary|Stage 1: Maximum Tolerated Dose (MTD) of Cobimetinib in 21/7 Schedule|"AEs were graded according to the NCI-CTCAE v3.0. A DLT was determined from clinical findings during the Study Treatment Period (Cycle 1, Days 1). MTD was defined as the dose at which no DLTs were observed. DLT was defined as either of the following occurring during the Study Treatment Period. The occurrence of a drug-related AE that, in the opinion of the CRC, was of potential clinical significance such that further dose escalation would expose participants in higher dose cohorts to risk of irreversible medical harm or require medical treatment to avoid irreversible medical harm or non-hematologic toxicity
Grade 3 or 4 events, including Grade 3 nausea and/or vomiting and/or Grade 3 diarrhea, despite prophylaxis and/or treatment Hematologic toxicity
Grade 4 thrombocytopenia
Grade 4 neutropenia of greater than or equal to (≥) 4 days’ duration
Grade 4 neutropenia of any duration with fever or documented infection"|Stage 1: Days 1 to 28 of Cycle 1|Safety population; Stage 1 participants only.||milligrams (mg)|||Number
739402|NCT00467779|Primary|Stage 1 and 1A: Number of Participants With Dose Limiting Toxicities (DLTs)|"Adverse events (AE) were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v3.0. DLT was defined as either of the following occurring during the Study Treatment Period. The occurrence of a drug-related AE that, in the opinion of the cohort review committee (CRC), was of potential clinical significance such that further dose escalation would expose participants in higher dose cohorts to risk of irreversible medical harm or require medical treatment to avoid irreversible medical harm or non-hematologic toxicity
Grade 3 or 4 events, including Grade 3 nausea and/or vomiting and/or Grade 3 diarrhea, despite prophylaxis and/or treatment Hematologic toxicity
Grade 4 thrombocytopenia
Grade 4 neutropenia of greater than or equal to (≥) 4 days’ duration
Grade 4 neutropenia of any duration with fever or documented infection"|Stage 1 and 1A: Days 1 to 28 of Cycle 1|Safety population; Stages 1 and 1A participants only.||participants|||Number
739403|NCT00467831|Primary|Survival at 2 Years|The number of subjects surviving after 24 months on study.|24 months|||participants|||Number
739404|NCT00467844|Secondary|To Assess the Efficacy of GTx-024 on Muscle Function (Performance) as Measured by Stair Climb.|Change in stair climb power from baseline to 4 months. Stair climb power is defined power (watts)=[9.8 m/sec**2]*[weight (kg)]*[height of 12 steps(meters)]/ [time (seconds) up the 12 steps].|Four Months|The subjects were in the MITT population (had a post baseline DEXA) and had a month 4 stair climb assessment (observed cases).||watts||Full Range|Median
739405|NCT00467844|Primary|The Efficacy of GTx-024 on Total Body Lean Mass.|Change in total body lean mass as measured by dual energy x-ray absorptiometry (DEXA)from baseline to 4 months.|Baseline to Four Months|The number of participants were those subjects in the modified intent-to-treat population (defined as subjects with at least one post baseline DEXA for LBM) who had baseline and 4 month DEXA results for LBM (observed cases).||kg||Full Range|Median
739406|NCT00467857|Secondary|Number of Patients With Alcohol Use, Tobacco Use, or Obesity With Surgical Site Infection (SSI)|Number of patients with risk factors of alcohol use, tobacco use, or obesity who developed an SSI at the sternal and/or graft site|30 days|Subset of Intention to treat participants with alcohol use, tobacco use, or obesity||Participants|||Number
739407|NCT00467857|Secondary|Number of Patients With SSI at the Sternal Site and/or Graft Site|Number of patients who develop at least one surgical site infection at the sternal or graft site during the 30 day post-op follow-up period|30 days|Intention to treat||Participants|||Number
739408|NCT00467857|Secondary|Post-incision Bacterial Count - Graft Site|Total bacterial counts from samples of skin flora of the graft incision site taken immediately following the surgical incision|Immediately after surgical incision|Per protocol||log CFU/mL||Standard Deviation|Mean
739409|NCT00467857|Secondary|Post-incision Bacterial Count - Sternal Site|Total bacterial counts from samples of skin flora of the sternal incision site taken immediately following the surgical incision|Immediately after surgical incision|Per protocol||log CFU/mL||Standard Deviation|Mean
739410|NCT00467857|Secondary|Change in Bacterial Count From Pre-skin Preparation to Post-incision - Graft Site|Total bacterial counts from samples of skin flora from the graft incision site immediately after incision minus before surgery (prior to skin prep)|Before surgery (prior to skin preparation) and immediately after incision|Per protocol||log CFU/mL||Standard Deviation|Mean
739411|NCT00467857|Primary|Change in Number of Unique Bacterial Isolates From Pre-skin Preparation to Post-CABG - Graft Site|Number of unique bacterial colony types isolated from samples of skin flora taken from the graft incision site after surgery minus before surgery (prior to skin prep). Unique colonies were determined based on Gram stain, colony morphology, catalase, coagulase, or staphylococci latex agglutination and oxidase tests.|Before surgery (prior to skin preparation) and after surgery (after closing fascia)|Per protocol||isolates||Standard Deviation|Mean
739412|NCT00467857|Secondary|Change in Bacterial Count From Pre-skin Preparation to Post-incision - Sternal Site|Total bacterial counts from samples of skin flora from the sternal incision site immediately after incision minus before surgery (prior to skin prep)|Before surgery (prior to skin preparation) and immediately after incision|Per protocol||log CFU/mL||Standard Deviation|Mean
739413|NCT00467857|Secondary|Change in the Number of Unique Bacterial Isolates From Pre-skin Preparation to Post-incision - Graft Site|Number of unique bacterial colony types isolated from samples of skin flora from the graft incision site immediately after the incision minus before surgery (prior to surgical skin prep). Unique colonies were determined based on Gram stain, colony morphology, catalase, coagulase, or staphylococci latex agglutination and oxidase tests.|Before surgery (prior to skin preparation) and immediately after incision|Per protocol||isolates||Standard Deviation|Mean
739414|NCT00467857|Secondary|Change in the Number of Unique Bacterial Isolates From Pre-skin Preparation to Post-incision - Sternal Site|Number of unique bacterial colony types isolated from samples of skin flora from the sternal incision site immediately after the incision minus before surgery (prior to surgical skin prep). Unique colonies were determined based on Gram stain, colony morphology, catalase, coagulase, or staphylococci latex agglutination and oxidase tests.|Before surgery (prior to skin preparation) and immediately after incision|Per protocol||isolates||Standard Deviation|Mean
739415|NCT00467857|Secondary|Post-CABG Procedure Bacterial Count - Graft Site|Total bacterial counts from samples of skin flora of the graft incision site taken immediately following the CABG procedure.|Post-surgery|Per protocol||log CFU/mL||Standard Deviation|Mean
739416|NCT00467857|Secondary|Post-CABG Procedure Bacterial Count - Sternal Site|Total bacterial counts from samples of skin flora of the sternal incision site taken immediately following the CABG procedure.|Post-surgery|Per protocol||log CFU/mL||Standard Deviation|Mean
739417|NCT00467857|Secondary|Change in Bacterial Count From Pre-skin Preparation to Post-CABG - Graft Site|Total bacterial counts from samples of skin flora from the graft incision site after surgery minus before surgery (prior to skin prep).|Before surgery (prior to skin preparation) and after surgery (after closing fascia)|Per protocol||log CFU/mL||Standard Deviation|Mean
739418|NCT00467857|Secondary|Change in Bacterial Count From Pre-skin Preparation to Post-CABG - Sternal Site|Total bacterial counts from samples of skin flora from the sternal incision site after surgery minus before surgery (prior to skin prep).|Before surgery (prior to skin preparation) and after surgery (after closing fascia)|Per protocol||log CFU/mL||Standard Deviation|Mean
739419|NCT00467857|Primary|Change in Number of Unique Bacterial Isolates From Pre-skin Preparation to Post-CABG - Sternal Site|Number of unique bacterial colony types isolated from samples of skin flora taken from the sternal incision site after surgery minus before surgery (prior to skin prep). Unique colonies were determined based on Gram stain, colony morphology, catalase, coagulase, or staphylococci latex agglutination and oxidase tests.|Before surgery (prior to skin preparation) and after surgery (after closing fascia)|Per protocol||isolates||Standard Deviation|Mean
739420|NCT00467870|Secondary|Serum Total Testosterone Maximum Concentration in Part C2||Screening; day 0; days 0, 4, 7, 11, and 14 post injection at week 4; and weeks 14, 24, 34, and 44|Total patient sample/PK sample includes participants who were enrolled, received injection 2, and had at least 1 post-injection 2 IPK sample (no participants were excluded)||ng/dL||Standard Deviation|Mean
739421|NCT00467870|Secondary|Trough Assessments of Serum Total Testosterone Concentrations in Part C2||Screening; day 0; and weeks 4, 14, 24, 34, and 44|Total patient sample/PK sample includes participants who were enrolled, received injection 2, and had at least 1 post-injection 2 IPK sample (no participants were excluded)||ng/dL||Standard Deviation|Mean
739422|NCT00467870|Secondary|Percentage of Participants With Serum Total Testosterone Concentrations Outside the Normal Range in Part C2|Serum total testosterone concentrations outside the normal range are categorized as <300 ng/dL (below lower limit of normal range) and >1000 ng/dL (above upper limit of normal range)|Screening; day 0; days 0, 4, 7, 11, and 14 post injection at week 4; weeks 14, 24, 34, and 44|Total patient sample/PK sample includes participants who were enrolled, received injection 2, and had at least 1 post-injection 2 IPK sample (no participants were excluded)||percentage of participants|||Number
739424|NCT00467870|Secondary|Serum Dihydrotestosterone Concentrations During the 2nd Injection Interval in Part C2||Days 0, 4, 7, 11, 14, and 70 post injection at week 4|Total patient sample/PK sample includes participants who were enrolled, received injection 2, and had at least 1 post-injection 2 IPK sample (no participants were excluded)||pg/mL||Standard Deviation|Mean
739425|NCT00467870|Secondary|Percentage of Participants With at Least 1 Serum Total Testosterone Concentration >1000, >1100, >1250, and <300 or >1000 ng/dL During the 2nd Injection Interval in Part C2||Days 0, 4, 7, 11, 14, and 70 post injection at week 4|Total patient sample/PK sample includes participants who were enrolled, received injection 2, and had at least 1 post-injection 2 IPK sample (no participants were excluded)||percentage of participants|||Number
739426|NCT00467870|Secondary|Change in Weight From Baseline to Week 24 in Part C||Baseline, Week 24|PK population includes participants who had a minimum of 4 serum total testosterone concentration values within the 3rd injection interval (13 participants were excluded from analysis); 1 additional participant did not have a measurement at week 24 and was also excluded from analysis||kg||Standard Deviation|Mean
739427|NCT00467870|Secondary|Change in Body Mass Index From Baseline to Week 24 in Part C|Difference in Body Mass Index (BMI) from baseline to week 24 calculated from weight (kg) divided by height squared (m2)|Baseline, Week 24|PK population includes participants who had a minimum of 4 serum total testosterone concentration values within the 3rd injection interval (13 participants were excluded from analysis); 1 additional participant did not have a measurement at week 24 and was also excluded from analysis||kg/m2||Standard Deviation|Mean
739428|NCT00467870|Secondary|Percentage of Participants by Collapsed Category for Each Parameter of the Male Patient Global Assessment (M-PGA) at Day 21 of the 3rd Injection Interval in Part C|M-PGA is a 5-item self-report questionnaire to assess perception of change from pretreatment or baseline in hypogonadal symptoms including confidence/self-esteem, sexual performance, moods/behavior, overall feeling of well-being, and satisfaction with study treatment rated on a 7-point scale where items 1-4 were rated as 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse), 7 (very much worse) and item 5 was rated as 1 (very much satisfied), 2 (much satisfied), 3 (minimally satisfied), 4 (neither satisfied nor dissatisfied), 5 (minimally dissatisfied), 6 (much dissatisfied), 7 (very much dissatisfied). Collapsed ratings: Improved=Very much, much, or minimally improved; Worsened=Very much, much, or minimally worse; No change; Satisfied=Very much, much, or minimally satisfied; Not satisfied=Very much, much, or minimally dissatisfied; No opinion (neither satisfied nor dissatisfied).|Day 21 post injection at week 14|Pharmacokinetic (PK) population includes participants who had a minimum of 4 serum total testosterone concentration values within the 3rd injection interval (13 participants were excluded from analysis)||percentage of participants||95% Confidence Interval|Number
739429|NCT00467870|Secondary|Percentage of Participants With Serum Total Testosterone Maximum Concentration ≤1500, >1500 to <1800, 1800 to 2500, and >2500 ng/dL During the 4th Injection Interval in Part C||Days 0, 4, 7, 11, 42, and 70 post injection at week 24|Steady-state PK population includes all participants in the PK population with non-missing 4th and 5th injection serum total testosterone concentrations (26 participants were excluded from analysis)||percentage of participants||95% Confidence Interval|Number
739430|NCT00467870|Secondary|Percentage of Participants With Clinical Success During the 4th Injection Interval in Part C|Clinical success is defined as having both Cavg and Ctrough between 300 and 1000 ng/dL|Days 0, 4, 7, 11, 42, and 70 post injection at week 24|Steady-state PK population includes all participants in the PK population with non-missing 4th and 5th injection serum total testosterone concentrations (26 participants were excluded from analysis)||percentage of participants||95% Confidence Interval|Number
739431|NCT00467870|Secondary|Time to First Serum Total Testosterone Concentration <300 ng/dL Following the 4th Injection Interval in Part C||Days 0, 4, 7, 11, 42, and 70 post injection at week 24|Steady-state PK population includes all participants in the PK population with non-missing 4th and 5th injection serum total testosterone concentrations (26 participants were excluded from analysis); an additional 57 participants who did not have serum total testosterone concentrations <300 ng/dL were also excluded from analysis||days||Standard Deviation|Mean
739432|NCT00467870|Secondary|Percentage of Participants With Average Serum Total Testosterone Concentration ≥300 ng/dL During the 4th Injection Interval in Part C||Days 0, 4, 7, 11, 42, and 70 post injection at week 24|Steady-state PK population includes all participants in the PK population with non-missing 4th and 5th injection serum total testosterone concentrations (26 participants were excluded from analysis)||percentage of participants||95% Confidence Interval|Number
739433|NCT00467870|Secondary|Percentage of Participants With at Least 1 Serum Total Testosterone Level <300 ng/dL at Any Time During the 4th Injection Interval in Part C||Days 0, 4, 7, 11, 42, and 70 post injection at week 24|Steady-state PK population includes all participants in the PK population with non-missing 4th and 5th injection serum total testosterone concentrations (26 participants were excluded from analysis)||percentage of participants||95% Confidence Interval|Number
739434|NCT00467870|Secondary|Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration Criteria for Success During the 4th Injection Interval in Part C|Success is defined as having ≥85% of participants with Cmax ≤1500 ng/dL, ≤5% of participants with Cmax 1800-2500 ng/dL, and no participants with Cmax >2500 ng/dL.|Days 0, 4, 7, 11, 42, and 70 post injection at week 24|Steady-state PK population includes all participants in the PK population with non-missing 4th and 5th injection serum total testosterone concentrations (26 participants were excluded from analysis)||percentage of participants||95% Confidence Interval|Number
739435|NCT00467870|Secondary|Percentage of Participants With Serum Total Testosterone Maximum Concentration ≤1500, >1500 to <1800, 1800 to 2500, and >2500 ng/dL During the 3rd Injection Interval in Part C||Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14|PK population includes participants who had a minimum of 4 serum total testosterone concentration values within the 3rd injection interval (13 participants were excluded from analysis)||percentage of participants||95% Confidence Interval|Number
739436|NCT00467870|Secondary|Percentage of Participants With Clinical Success During the 3rd Injection Interval in Part C|Clinical success is defined as having both Cavg and Ctrough between 300 and 1000 ng/dL|Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14|PK population includes participants who had a minimum of 4 serum total testosterone concentration values within the 3rd injection interval (13 participants were excluded from analysis)||percentage of participants||95% Confidence Interval|Number
739437|NCT00467870|Secondary|Time to First Serum Total Testosterone Concentration <300 ng/dL Following the 3rd Injection Interval in Part C||Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14|PK population includes participants who had a minimum of 4 serum total testosterone concentration values within the 3rd injection interval (13 participants were excluded from analysis); an additional 57 participants who did not have serum total testosterone concentrations <300 ng/dL were also excluded from analysis||days||Standard Deviation|Mean
739438|NCT00467870|Secondary|Percentage of Participants With Serum Total Testosterone Average Concentration ≥300 ng/dL During the 3rd Injection Interval in Part C||Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14|PK population includes participants who had a minimum of 4 serum total testosterone concentration values within the 3rd injection interval (13 participants were excluded from analysis)||percentage of participants||95% Confidence Interval|Number
739439|NCT00467870|Secondary|Percentage of Participants With at Least 1 Serum Total Testosterone Level <300 ng/dL at Any Time During the 3rd Injection Interval in Part C||Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14|PK population includes participants who had a minimum of 4 serum total testosterone concentration values within the 3rd injection interval (13 participants were excluded from analysis)||percentage of participants||95% Confidence Interval|Number
739440|NCT00467870|Secondary|Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration Criteria for Success During the 3rd Injection Interval in Part C|Success is defined as having ≥85% of participants with Cmax ≤1500 ng/dL, ≤5% of participants with Cmax 1800-2500 ng/dL, and no participants with Cmax >2500 ng/dL.|Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14|PK population includes participants who had a minimum of 4 serum total testosterone concentration values within the 3rd injection interval (13 participants were excluded from analysis)||percentage of participants||95% Confidence Interval|Number
739441|NCT00467870|Secondary|Serum Total Testosterone Maximum Concentration in Part B||Post injection at week 1; post injection at week 8; days 0, 4, 7, 11, 14, 21, 28, 42, 56, 70, and 84 post injection at week 20; and post injection at weeks 32, 44, 56, 68, and 80|Total patient sample includes participants who were enrolled and received at least 1 injection; participants without any IPK sample collections were excluded from this analysis (2 from B-TU 750 mg and 12 from B-TU 1000 mg)||ng/dL||Standard Deviation|Mean
739442|NCT00467870|Secondary|Serum Total Testosterone Maximum Concentration in Part A||Days 0, 4, 7, 11, 14, 21, 28, 42, 56, 70, and 84 post injection at week 1, week 12, week 24, and week 36; and post injection at weeks 48, 60, 72, 84, 96, 108, and 120|Total patient sample includes participants who were enrolled and received at least 1 injection; participants without any IPK sample collections were excluded from this analysis (20 from A-TU 750 mg and 11 from A-TU 1000 mg)||ng/dL||Standard Deviation|Mean
739443|NCT00467870|Primary|Serum Total Testosterone at the End of the Dosing Interval Following the 2nd Injection in Part C2|Serum total testosterone Ctrough derived from the 2nd injection IPK interval|Day 70 post injection at week 4|Total patient sample/PK sample includes participants who were enrolled, received injection 2, and had at least 1 post-injection 2 IPK sample (no participants were excluded)||ng/dL||Standard Deviation|Mean
739444|NCT00467870|Primary|Serum Total Testosterone Maximum Concentration During the 2nd Injection Interval in Part C2|Serum total testosterone Cmax derived from the 2nd injection IPK interval|Days 0, 4, 7, 11, 14, and 70 post injection at week 4|Total patient sample/PK sample includes participants who were enrolled, received injection 2, and had at least 1 post-injection 2 IPK sample (no participants were excluded)||ng/dL||Standard Deviation|Mean
739445|NCT00467870|Primary|Serum Total Testosterone Average Concentration During the 2nd Injection Interval in Part C2|Serum total testosterone Cavg derived from the 2nd injection IPK interval|Days 0, 4, 7, 11, 14, and 70 post injection at week 4|Total patient sample/PK sample includes participants who were enrolled, received injection 2, and had at least 1 post-injection 2 IPK sample (no participants were excluded)||ng/dL||Standard Deviation|Mean
739446|NCT00467870|Primary|Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration Criteria for Success During the 2nd Injection Interval in Part C2|Success was defined as having ≥85% of participants with Cmax ≤1500 ng/dL, ≤5% of participants with Cmax 1800-2500 ng/dL, and no participants with Cmax >2500 ng/dL.|Days 0, 4, 7, 11, 14, and 70 post injection at week 4|Total patient sample/PK sample includes participants who were enrolled, received injection 2, and had at least 1 post-injection 2 IPK sample (no participants were excluded)||percentage of participants|||Number
739447|NCT00467870|Primary|Serum Total Testosterone Concentration at the End of the Dosing Interval Following the 4th Injection in Part C|Serum total testosterone Ctrough derived from the 4th injection IPK interval|Day 70 post injection at week 24|Steady-state PK population includes all participants in the PK population with non-missing 4th and 5th injection serum total testosterone concentrations (26 participants were excluded from analysis)||ng/dL||Standard Deviation|Mean
739448|NCT00467870|Primary|Serum Total Testosterone Maximum Concentration During the 4th Injection Interval in Part C|Serum total testosterone Cmax derived from the 4th injection IPK interval|Days 0, 4, 7, 11, 42, and 70 post injection at week 24|Steady-state PK population includes all participants in the PK population with non-missing 4th and 5th injection serum total testosterone concentrations (26 participants were excluded from analysis)||ng/dL||Standard Deviation|Mean
739449|NCT00467870|Primary|Serum Total Testosterone Average Concentration During the 4th Injection Interval in Part C|Serum total testosterone Cavg derived from the 4th injection IPK interval|Days 0, 4, 7, 11, 42, and 70 post injection at week 24|Steady-state PK population includes all participants in the PK population with non-missing 4th and 5th injection serum total testosterone concentrations (26 participants were excluded from analysis)||ng/dL||Standard Deviation|Mean
739450|NCT00467870|Primary|Percentage of Participants Meeting Serum Total Testosterone Average Concentration Criteria for Responder During the 4th Injection Interval in Part C|Responders were participants with serum total testosterone Cavg between 300 and 1000 ng/dL derived from the 4th injection IPK interval.|Days 0, 4, 7, 11, 42, and 70 post injection at week 24|Steady-state PK population includes all participants in the PK population with non-missing 4th and 5th injection serum total testosterone concentrations (26 participants were excluded from analysis)||percentage of participants||95% Confidence Interval|Number
739884|NCT00459810|Primary|Prostate Specific Antigen (PSA) Response Rate: Number of Subjects With Decreases in PSA of at Least 50%|PSA response rate is defined at the number of patients who experienced a PSA decline of equal to or greater than 50%, confirmed by a second measurement at least 4 weeks later.|While receiving study agents (on average, 3 months)|||Participants|||Number
739451|NCT00467870|Primary|Serum Total Testosterone Concentration at the End of the Dosing Interval Following the 3rd Injection in Part C|Serum total testosterone concentration at the end of the dosing interval (Ctrough) derived from the 3rd injection IPK interval|Day 70 post injection at week 14|PK population includes participants who had a minimum of 4 serum total testosterone concentration values within the 3rd injection interval (13 participants were excluded from analysis)||ng/dL||Standard Deviation|Mean
739452|NCT00467870|Primary|Serum Total Testosterone Maximum Concentration During the 3rd Injection Interval in Part C|Serum total testosterone maximum concentration (Cmax) derived from the 3rd injection IPK interval|Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14|PK population includes participants who had a minimum of 4 serum total testosterone concentration values within the 3rd injection interval (13 participants were excluded from analysis)||ng/dL||Standard Deviation|Mean
739453|NCT00467870|Primary|Serum Total Testosterone Average Concentration During the 3rd Injection Interval in Part C|Serum total testosterone Cavg derived from the 3rd injection IPK interval|Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14|PK population includes participants who had a minimum of 4 serum total testosterone concentration values within the 3rd injection interval (13 participants were excluded from analysis)||ng/dL||Standard Deviation|Mean
739454|NCT00467870|Primary|Percentage of Participants Meeting Serum Total Testosterone Average Concentration Criteria for Responder During the 3rd Injection Interval in Part C|Responders were participants with serum total testosterone average concentration (Cavg) between 300 and 1000 ng/dL derived from the 3rd injection intensive pharmacokinetic (IPK) interval.|Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14|Pharmacokinetic (PK) population includes participants who had a minimum of 4 serum total testosterone concentration values within the 3rd injection interval (13 participants were excluded from analysis)||percentage of participants||95% Confidence Interval|Number
739455|NCT00467896|Primary|Change in Inhalation-times Rate From Period I (Iloprost PD-6) to Period II (Iloprost PD-15)|Change in the percentage of full doses (5 µg) of iloprost delivered within the recommended time frame for receiving a full dose of iloprost (4-10 minutes). Iloprost dosing information was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (< 12.5%, ≥ 12.5% to < 100%, and Full)|37 days prior to first dose of iloprost PD-15/37 days following first dose of iloprost PD-15|Modified intent-to-treat (MITT) population which includes all patients enrolled into the study who had at least 32 consecutive days of daily inhalation times data with PD-6, and at least 6 consecutive days of daily inhalation times data with PD-15.||percentage of full doses administered||Standard Deviation|Mean
739456|NCT00467896|Secondary|Heart Rate (HR) - Iloprost PD-15 (Day 1 and Day 7, Period II)|HR was recorded on Day 1 and Day 7 at 3 different timepoints: pre-inhalation, immediately post-inhalation and 15 minutes after inhalation of iloprost using PD-15|Day 1 and Day 7, following the first dose of iloprost PD-15|safety population||beats per minute||Standard Deviation|Mean
739457|NCT00467896|Secondary|Heart Rate (HR) - Iloprost PD-6 (Period I)|HR was recorded on Day 1 at 3 different timepoints: pre-inhalation, immediately post-inhalation and 15 minutes after inhalation of iloprost using PD-6|Day 1, prior to first dose of iloprost PD-15|safety population||beats per minute||Standard Deviation|Mean
739458|NCT00467896|Secondary|Diastolic Blood Pressure (DBP) - Iloprost PD-15 (Day 1 and Day 7, Period II)|DBP was recorded on Day 1 and Day 7 at 3 different timepoints: pre-inhalation, immediately post-inhalation and 15 minutes after inhalation of iloprost using PD-15|Day 1 and Day 7, following the first dose of iloprost PD-15|safety population||mmHg||Standard Deviation|Mean
739459|NCT00467896|Secondary|Diastolic Blood Pressure (DBP) - Iloprost PD-6 (Period I)|DBP was recorded on Day 1 at 3 different timepoints: pre-inhalation, immediately post-inhalation and 15 minutes after inhalation of iloprost using PD-6|Day 1, prior to first dose of iloprost PD-15|safety population||mmHg||Standard Deviation|Mean
739460|NCT00467896|Secondary|Systolic Blood Pressure (SBP) - Iloprost PD-15 (Day 1 and Day 7, Period II)|SBP was recorded on Day 1 and Day 7 at 3 different timepoints: pre-inhalation, immediately post-inhalation and 15 minutes after inhalation of iloprost using PD-15|Day 1 and Day 7, following the first dose of iloprost PD-15|safety population||mmHg||Standard Deviation|Mean
739461|NCT00467896|Secondary|Systolic Blood Pressure - Iloprost PD-6 (Period I)|SBP was recorded on Day 1 at 3 different timepoints: pre-inhalation, immediately post-inhalation and 15 minutes after inhalation of iloprost using PD-6|Day 1, prior to first dose of iloprost PD-15|safety population||mmHg||Standard Deviation|Mean
739462|NCT00467896|Secondary|Percentage of Daily Doses Within the 6-9 Times/Day Treatment Regimen - Iloprost PD-15 (Period II)|The frequency of daily inhalations was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (< 12.5%, ≥ 12.5% to < 100%, and Full)|37 days following first dose of iloprost PD-15|Modified intent-to-treat (MITT) population which includes all patients enrolled into the study who had at least 32 consecutive days of daily inhalation times data with PD-6, and at least 6 consecutive days of daily inhalation times data with PD-15.||percentage of daily doses||Standard Deviation|Mean
739463|NCT00467896|Primary|Inhalation-times Rate - Iloprost PD-15 (Period II)|Defined as the percentage of full doses (5 µg) of iloprost delivered within the recommended time frame for receiving a full dose of iloprost (4-10 minutes). Iloprost dosing information was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (< 12.5%, ≥ 12.5% to < 100%, and Full)|37 days following first dose of iloprost PD-15|Modified intent-to-treat (MITT) population which includes all patients enrolled into the study who had at least 32 consecutive days of daily inhalation times data with PD-6, and at least 6 consecutive days of daily inhalation times data with PD-15.||percentage of full doses administered||Standard Deviation|Mean
739464|NCT00467896|Secondary|Percentage of Daily Doses Within the 6–9 Times/Day Treatment Regimen - Iloprost PD-6 (Period I)|The frequency of daily inhalations was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (< 12.5%, ≥ 12.5% to < 100%, and Full)|37 days prior to first dose of iloprost PD-15|Modified intent-to-treat (MITT) population which includes all patients enrolled into the study who had at least 32 consecutive days of daily inhalation times data with PD-6, and at least 6 consecutive days of daily inhalation times data with PD-15.||percentage of daily doses||Standard Deviation|Mean
739465|NCT00467896|Secondary|Percentage of Complete Doses Administered - Iloprost PD-15 (Period II)|The frequency of dose completion was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (< 12.5%, ≥ 12.5% to < 100%, and Full)|37 days following first dose of iloprost PD-15|Modified intent-to-treat (MITT) population which includes all patients enrolled into the study who had at least 32 consecutive days of daily inhalation times data with PD-6, and at least 6 consecutive days of daily inhalation times data with PD-15.||percentage of complete doses||Standard Deviation|Mean
739466|NCT00467896|Secondary|Percentage of Complete Doses Administered - Iloprost PD-6 (Period I)|The frequency of dose completion was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (< 12.5%, ≥ 12.5% to < 100%, and Full)|37 days prior to first dose of iloprost PD-15|Modified intent-to-treat (MITT) population which includes all patients enrolled into the study who had at least 32 consecutive days of daily inhalation times data with PD-6, and at least 6 consecutive days of daily inhalation times data with PD-15.||percentage of complete doses||Standard Deviation|Mean
739467|NCT00467896|Secondary|Daily Inhalation Duration - Iloprost PD-15 (Period II)|Average daily inhalation duration. The inhalation duration was available from the I-neb® device, which recorded the date and time of each inhalation, as well as the inhalation completion status (< 12.5%, ≥ 12.5% to < 100%, and Full)|37 days following first dose of iloprost PD-15|Modified intent-to-treat (MITT) population which includes all patients enrolled into the study who had at least 32 consecutive days of daily inhalation times data with PD-6, and at least 6 consecutive days of daily inhalation times data with PD-15.||minutes||Standard Deviation|Mean
739468|NCT00467896|Secondary|Daily Inhalation Duration - Iloprost PD-6 (Period I)|Average daily inhalation duration. The inhalation duration was available from the I-neb® device, which recorded the date and time of each inhalation, as well as the inhalation completion status (< 12.5%, ≥ 12.5% to < 100%, and Full)|37 days prior to first dose of iloprost PD-15|Modified intent-to-treat (MITT) population which includes all patients enrolled into the study who had at least 32 consecutive days of daily inhalation times data with PD-6, and at least 6 consecutive days of daily inhalation times data with PD-15.||minutes||Standard Deviation|Mean
739469|NCT00467896|Secondary|Number of Daily Inhalations - Iloprost PD-15 (Period II)|Average number of daily inhalations. The number of daily inhalations was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (< 12.5%, ≥ 12.5% to < 100%, and Full)|37 days following first dose of iloprost PD-15|Modified intent-to-treat (MITT) population which includes all patients enrolled into the study who had at least 32 consecutive days of daily inhalation times data with PD-6, and at least 6 consecutive days of daily inhalation times data with PD-15.||inhalations/day||Standard Deviation|Mean
739470|NCT00467896|Secondary|Number of Daily Inhalations - Iloprost PD-6 (Period I)|Average number of daily inhalations. The number of daily inhalations was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (< 12.5%, ≥ 12.5% to < 100%, and Full)|37 days prior to first dose of iloprost PD-15|Modified intent-to-treat (MITT) population which includes all patients enrolled into the study who had at least 32 consecutive days of daily inhalation times data with PD-6, and at least 6 consecutive days of daily inhalation times data with PD-15.||inhalations/day||Standard Deviation|Mean
739471|NCT00467896|Primary|Inhalation-times Rate - Iloprost PD-6 (Period I)|Defined as the percentage of full doses (5 µg) of iloprost delivered within the recommended time frame for receiving a full dose of iloprost (4-10 minutes). Iloprost dosing information was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (< 12.5%, ≥ 12.5% to < 100%, and Full)|37 days prior to first dose of iloprost PD-15|Modified intent-to-treat (MITT) population which includes all patients enrolled into the study who had at least 32 consecutive days of daily inhalation times data with PD-6, and at least 6 consecutive days of daily inhalation times data with PD-15.||percentage of full doses administered||Standard Deviation|Mean
739472|NCT00467961|Secondary|Secondary Objectives Include Determining the Rate od Standard Transplant Outcome Variables: Toxicity, Relapse, Graft Rejection, Disease Free Survival.||3 years maximum||||||
739473|NCT00467961|Primary|To Determine if Selective T Cell Depletion Using the Photodepletion Procedure Can Substantially Reduce the Rate of Severe Acute GVHD (Grade III/IV) After Matched Sibling Transplantation Followed by Low-dose or no Immunosuppression.|Patients will receive a selectively photodepleted lymphocyte product which will be delivered together with the T cell depleted stem cell product on the day of transplantation. Subjects will receive a conditioning regimen of cyclophosphamide, fludarabine and total body irradiation followed by an infusion of a stem cell product prepared using the Miltenyi CliniMacs system for CD34-selection and a lymphocyte product that has been selectively depleted using the photodepletion approach. Older subjects will receive a lower dose of irradiation to reduce the regimen intensity. To determine appropriate level of post transplant immunosuppression, a three sequential de-escalation stage design for timing of cyclosporine will be utilized. To determine if selective T cell depletion using the photodepletion procedure can substantially reduce the number of severe acute GVHD (grade III/IV) after transplantation followed by low-dose or no immunosuppression.|Day 90|The study accrued 31 transplant recipents and 30 donors. Of the 31 transplant recipients, there were 24 evaluable recipients. Seven of the 24 recipients did not receive transplantation.||participants|||Number
739474|NCT00468052|Secondary|Participants Requiring Morphine Rescue in PACU||arrival in PACU to 2 hours postoperatively|||participants|||Number
739475|NCT00468052|Secondary|Number of Participants With SpO2 < or Equal to 95%||on arrival to PACU and 2 hours postoperatively|||participants|||Number
739476|NCT00468052|Secondary|Time to Extubation|defined as time from end of surgery to tracheal extubation|at end of surgical procedure|per protocol||minutes||Standard Deviation|Mean
739477|NCT00468052|Secondary|Time to Awaken|defined as spontaneous eye opening or on command|at end of surgery|per protocol||minutes||Standard Deviation|Mean
739478|NCT00468052|Secondary|Hemodynamic Stability|Participants whose heart rate per minute was below 60 intraoperatively. Participants whose systolic blood pressure dremonstrated < 30% decrease from baseline and sustained for 5 minutes received rescue as defined by the protocol.|intraoperatively|||participants|||Number
739480|NCT00468052|Primary|Emergence Agitation and Pain|"emergence agitation and pain will be assessed. Pediatric Anesthesia Emergence Delirium Scale (PAED) range 0-20 a lower score indicates the child is calm and the higher score indicates severe agitation. Cole Agitation Scale was employed which is a 5 point Likert scale. Parameters ranging 1 to 5 1=child is calm and 5 =the child is severly agitated .
Objective Pain Score range is 0-10 (higher score the greater pain). 3 Parameters are captured systolic b/p,crying, movements, agitation , complaints of pain"|On arrival to PACU and 2 hours postoperatively|per protocol, OPS, PAED and Cole scale are expressed as median values of the maximum score||units on a scale||Full Range|Median
739481|NCT00468104|Secondary|Number of Participants With Clinical Symptoms of Sepsis That Responded to Therapy|patients were followed for 6 weeks and resolution of sepsis was documented|6 weeks|protocol design prevented assigning symptom resolution to a specific intervention therefore secondary outcome measures in 6 weeks were not analyzed||participants|||Number
739482|NCT00468104|Secondary|Number of Participants With Shortness of Breath That Responded to Therapy|patients were followed for 6 weeks and clinical symptoms of resolution of shortness of breath were documented|6 weeks|protocol design prevented assigning symptom resolution to a specific intervention therefore secondary outcome measures in 6 weeks were not analyzed||participants|||Number
739483|NCT00468104|Secondary|Number of Participants With Pleural Effusion/Empyema That Responded to Therapy|patients were followed for 6 weeks and CXR and CT scan were done to document resolution of pleural effusion/empyema|6 weeks|protocol design prevented assigning symptom resolution to a specific intervention therefore secondary outcome measures in 6 weeks were not analyzed||participants|||Number
739484|NCT00468104|Secondary|Number of Participants With Pneumonia That Responded to Therapy|patients were followed for 6 weeks and CXR and CT scan were done to document resolution of pneumonia|6 weeks|protocol design prevented assigning symptom resolution to a specific intervention therefore secondary outcome measures in 6 weeks were not analyzed||participants|||Number
739485|NCT00468104|Primary|No Surgical Intervention|CT scans of the chest and Chest X rays (CXR) were used to determine resolution of Pleural effusions/empyema/ pneumonia after 3 days of Alteplase/ Placebo therapy. If no response was noted with the first intervention patients were offered surgery --Decortiation/ Video Assisted Thoracic Surgery (VATS) or to receive the second intervention. Patients that failed the second intervention were offered surgery.|patients were followed six weeks per protocol. Most patients treated with Alteplase were also followed for up to six months|intention to treat||participants|||Number
739486|NCT00468143|Secondary|Self Report|Self-reported adherence was ascertained via retrospective self-report of daily regimen adherence. Participants were considered adherent for Adderall IR (Methamphetamine salts) if they took the first does in the morning within 30 minutes of waking, and then each subsequent dose in 5-hour intervals (within 30 minutes). For Adderall XR (Methamphetamine salts), participants were considered adherent if they took the single daily dose in the morning within 30 minutes of waking. The number given below represents the total number of self-reported adherent participants divided by the total number of participants per group, times 100 (to obtain percentage).|At clinic visit 3, 4, 5, 7, 8, and 9 (over 8 weeks)|||percentage of participants adherent|||Number
739487|NCT00468143|Secondary|Pill Count|Study staff counted unused medication at each weekly visit to yield a percentage of prescribed pills that were consumed. For each group, the number given will be the total number of consumed pills divided by total number of pill prescribed.|At clinic visit 3, 4, 5, 7, 8, and 9 (over 8 weeks)|||percentage of pills consumed|||Number
739488|NCT00468143|Primary|Medication Event Monitoring System (MEMS®) Time Adherence|Time adherence (MEMSt) is the percentage of doses taken as prescribed within a specified time period. Adherence was measured as ≥ 80% of doses taken at the correct time. The number below is the percentage of subjects who were adherent.|The MEMS information was noted at clinic visit 3, 4, 5, 7, 8, and 9 (over 8 weeks)|||percentage of participants adherent|||Number
739489|NCT00468143|Primary|Medication Event Monitoring System (MEMS®) Regimen Adherence|Regimen adherence (MEMSr) is a percentage of the number of days in which the complete dose regimen was taken as prescribed. Adherence was measured as complete dose regimen taken on ≥ 90% of days. The number below is the total percentage of subjects who were adherent.|The MEMS information was noted at clinic visit 3, 4, 5, 7, 8, and 9 (over 8 weeks)|||percentage of participants adherent|||Number
739490|NCT00468143|Primary|Medication Event Monitoring System (MEMS®) Dosage Adherence|Dosage adherence (MEMSd) is the number of bottle openings divided by number of doses prescribed. Adherence was measured as ≥ 75% of the doses. The number below is the total percentage of subjects who were adherent.|The MEMS information was noted at clinic visit 3, 4, 5, 7, 8, and 9 (over 8 weeks)|These is the total of participants who completed the study.||percentage of participants adherent|||Number
739491|NCT00468208|Secondary|Disease Relapse|"Disease relapse was measured by a rise in the Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis (BVAS/WG) of greater than or equal to 1 after achieving remission.
The BVAS/WG is a validated disease activity index. The BVAS/WG is designed to document new or worsening clinically active vasculitis and consists of a set of items divided into nine organ based systems. BVAS/WG scores range from 0 to 63."|Measured monthly until common closing or early termination, up to 3 years and 4 months.|This study intended to examine safety and to explore preliminary signal for efficacy of abatacept in Wegener's granulomatosis. The sample size of 20 was based upon a sufficient number of subjects to begin such pilot explorations.||participants|||Number
739492|NCT00468208|Secondary|Meeting Common Closing|The number of subjects that reached the common closing date.|Number assessed at the time of common closing, up to 3 years and 4 months.|This study intended to examine safety and to explore preliminary signal for efficacy of abatacept in Wegener's granulomatosis. The sample size of 20 was based upon a sufficient number of subjects to begin such pilot explorations.||participants|||Number
739493|NCT00468208|Secondary|Disease Improvement|"Disease improvement was measured by a reduction in the Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis (BVAS/WG).
The BVAS/WG is a validated disease activity index. The BVAS/WG is designed to document new or worsening clinically active vasculitis and consists of a set of items divided into nine organ based systems. BVAS/WG scores range from 0 to 63."|Measured monthly until common closing or early termination, up to 3 years and 4 months.|This study intended to examine safety and to explore preliminary signal for efficacy of abatacept in Wegener's granulomatosis. The sample size of 20 was based upon a sufficient number of subjects to begin such pilot explorations.||participants|||Number
739494|NCT00468208|Secondary|Disease Remission|"Disease remission was measured by a Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis (BVAS/WG) of 0.
The BVAS/WG is a validated disease activity index. The BVAS/WG is designed to document new or worsening clinically active vasculitis and consists of a set of items divided into nine organ based systems. BVAS/WG scores range from 0 to 63."|Measured monthly until common closing or early termination,up to 3 years and 4 months.|This study intended to examine safety and to explore preliminary signal for efficacy of abatacept in Wegener's granulomatosis. The sample size of 20 was based upon a sufficient number of subjects to begin such pilot explorations.||participants|||Number
739495|NCT00468208|Primary|Safety of Abatacept - Number of Participants With Adverse Events|"This study examined the safety profile of this agent when used in Wegener's granulomatosis. Information was gathered on all adverse events with specific events being identified in the protocol for analysis that included the following:
Infection
Infusion reactions
Cytopenias
Transaminase elevation
Skin reactions
GI side effects
Malignancy
All adverse events were reportable for this study."|Measured continuously from the screening visit through to the 6 month post-treatment study visit, up to 3 years and 4 months.|This study intended to examine safety and to explore preliminary signal for efficacy of abatacept in Wegener's granulomatosis. The sample size of 20 was based upon a sufficient number of subjects to begin such pilot explorations.||participants|||Number
739496|NCT00468286|Secondary|Liver Function Tests|The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases >3x ULN and ALT increases >3x ULN with concurrently increased bilirubin >1.5 ULN.|1 year|||participants|||Number
739497|NCT00468286|Secondary|Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight|This outcome measure included incidence of markedly abnormal values in blood pressure (systolic and diastolic), pulse, and body weight during the trial. The table presents the number of participants with a normal baseline value and at least one post-baseline markedly abnormal value.|Baseline up to 1 year|||participants|||Number
739498|NCT00468286|Secondary|Serum Levels of Luteinizing Hormone (LH) Over Time||1 year|||IU/L||Full Range|Median
739499|NCT00468286|Secondary|Serum Levels of Follicle Stimulating Hormone (FSH) Over Time||1 year|||IU/L||Full Range|Median
739500|NCT00468286|Secondary|Serum Levels of PSA Over Time||1 year|||ng/mL||Full Range|Median
739501|NCT00468286|Secondary|Probability of no PSA Failure|Cumulative probability (%) and 95% confidence interval (CI) for completing the study without PSA failure. PSA failure was defined as two consecutive increases of 50%, and at least 5 ng/mL, compared to nadir (lowest level of PSA achieved).|1 year|||percentage of participants||95% Confidence Interval|Mean
739502|NCT00468286|Secondary|Probability of Testosterone at Castration Level (≤0.5 ng/mL) From Day 56 Through Day 364|Kaplan-Maier estimates of the cumulative probabilities of testosterone <=0.5 ng/mL from Day 56 to Day 364.|1 year|||percentage of participants||95% Confidence Interval|Mean
739503|NCT00468286|Secondary|Serum Levels of Testosterone Over Time||1 year|||ng/mL||Full Range|Median
739504|NCT00468286|Primary|Probability of Testosterone at Castration Level (≤0.5 ng/mL) From Day 28 Through Day 364|Kaplan-Maier estimates of the cumulative probabilities of testosterone <=0.5 ng/mL from Day 28 to Day 364.|1 year|||percentage of participants||95% Confidence Interval|Mean
739505|NCT00468299|Secondary|Complete Abortion at One Week|Complete abortion at one week; uterus demonstrated to be empty on transvaginal ultrasound|3 weeks|Per protocol||participants|||Number
739506|NCT00468299|Primary|Number of Women With Complete Abortion 24-48hrs After Receiving Medical Treatment for Early Pregnancy Failure.||24-48 hrs|||participants|||Number
739507|NCT00468312|Secondary|Change From Baseline in AM Peak Nasal Inspiratory Flow (PNIF) Averaged Over Days 2 to 15|Participants were to measure nasal airflow twice daily (in the morning prior to study drug dosing and in the evening) using their PNIF meter. The highest of 3 assessments was to be recorded in the electronic diary. The PNIF meter limits were between 30 and 370 liters/minute. Normal values range between 100 and 150 liters/minute. A positive change from Baseline correlates with improved nasal air flow.|Screening through 15 days daily|All randomized participants were to be included in the analysis (intent-to-treat principle). However, participants with a missing evaluation at a given visit or time point were not included in the analysis for that evaluation. This included participants without a baseline score for a given change-from-baseline evaluation.||liters/minute||Standard Deviation|Least Squares Mean
739508|NCT00468312|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Total Score at Endpoint (Last Post Baseline Evaluation Carried Forward)|The RQLQ consisted of 28 items that fell into the following seven domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. Each of the items was scored from 0 = not troubled to 6 = extremely troubled, and the total of the seven domains was the primary focus of this quality of life evaluation. The best possible score on this scale is 0 and the worst possible score on this scale is 42. The Endpoint was the last post baseline evaluation carried forward and was Day 15 for the majority of the participants.|Baseline and 15 days|The RQLQ tool is only validated in participants greater than or equal to 18 years of age. The analysis population included subjects who were randomized to treatment, answered the RQL questionnaire both at baseline and post baseline visits and were at least 18 years of age.||Score on a scale||Standard Deviation|Least Squares Mean
739509|NCT00468312|Secondary|Change From Baseline in AM NOW Nasal Congestion Score Averaged Over Days 2 to 15|Nasal congestion was one of the symptoms measures in the TNSS and was scored on a scale of 0=none, 1=mild, 2=moderate, and 3=severe. The best possible score on this scale is 0 and the worst possible score on this scale is 3.|Screening through 15 days daily|All randomized participants were to be included in the analysis (intent-to-treat principle). However, participants with a missing evaluation at a given visit or time point were not included in the analysis for that evaluation. This included participants without a baseline score for a given change-from-baseline evaluation.||Score on a scale||Standard Deviation|Least Squares Mean
739523|NCT00468481|Post-Hoc|Mean Plasma Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 4|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|up to week 4|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24||nmol/L||Standard Deviation|Mean
739510|NCT00468312|Primary|Change From Baseline in Average AM Instantaneous (NOW) Total Ocular Symptom Score (TOSS) Averaged Over Days 2 to 15|TOSS was defined as the sum of the following three ocular symptoms: redness of eyes, itching/burning eyes, and tearing/watering eyes; each symptom scored on a scale of 0=none, 1=mild, 2=moderate, and 3=severe. The best possible score on this scale is 0 and the worst possible score on the scale is 9.|Screening through 15 days daily|All randomized participants were to be included in the analysis (intent-to-treat principle). However, participants with a missing evaluation at a given visit or time point were not included in the analysis for that evaluation. This included participants without a baseline score for a given change-from-baseline evaluation.||Score on a scale||Standard Deviation|Least Squares Mean
739511|NCT00468312|Primary|Change From Baseline in Average AM Instantaneous (NOW) Total Nasal Symptom Score (TNSS) Averaged Over Days 2 to 15|TNSS was defined as the sum of the following four nasal symptoms: rhinorrhea, nasal congestion/stuffiness, nasal itching, and sneezing; each symptom scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe. The best possible score on this scale is 0 and the worst possible score on this scale is 12.|Screening through 15 days daily|All randomized participants were to be included in the analysis (intent-to-treat principle). However, participants with a missing evaluation at a given visit or time point were not included in the analysis for that evaluation. This included participants without a baseline score for a given change-from-baseline evaluation.||Score on a scale||Standard Deviation|Least Squares Mean
739512|NCT00468481|Post-Hoc|Mean Plasma Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 24|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|up to week 24|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||nmol/L||Standard Deviation|Mean
739513|NCT00468481|Post-Hoc|Mean Plasma Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 24|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|up to week 24|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||nmol/L||Standard Deviation|Mean
739514|NCT00468481|Post-Hoc|Mean Plasma Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 20|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|up to week 20|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||nmol/L||Standard Deviation|Mean
739515|NCT00468481|Post-Hoc|Mean Plasma Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 20|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|up to week 20|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||nmol/L||Standard Deviation|Mean
739516|NCT00468481|Post-Hoc|Mean Plasma Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 16|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|up to week 16|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||nmol/L||Standard Deviation|Mean
739517|NCT00468481|Post-Hoc|Mean Plasma Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 16|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|up to week 16|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||nmol/L||Standard Deviation|Mean
739518|NCT00468481|Post-Hoc|Mean Plasma Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 12|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|up to week 12|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||nmol/L||Standard Deviation|Mean
739519|NCT00468481|Post-Hoc|Mean Plasma Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 12|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|up to week 12|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||nmol/L||Standard Deviation|Mean
739520|NCT00468481|Post-Hoc|Mean Plasma Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 8|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|up to week 8|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||nmol/L||Standard Deviation|Mean
739521|NCT00468481|Post-Hoc|Mean Plasma Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 8|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|up to week 8|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||nmol/L||Standard Deviation|Mean
739522|NCT00468481|Post-Hoc|Mean Plasma Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 4|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|up to week 4|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||nmol/L||Standard Deviation|Mean
739524|NCT00468481|Post-Hoc|Mean Plasma Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Baseline|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|at baseline (week 0)|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24||nmol/L||Standard Deviation|Mean
739525|NCT00468481|Post-Hoc|Mean Plasma Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Baseline|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|at baseline (week 0)|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24||nmol/L||Standard Deviation|Mean
739526|NCT00468481|Post-Hoc|Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 24|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|up to week 24|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||nmol/L||Standard Deviation|Mean
739527|NCT00468481|Post-Hoc|Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 24|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|up to week 24|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||nmol/L||Standard Deviation|Mean
739528|NCT00468481|Post-Hoc|Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 20|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|up to week 20|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||nmol/L||Standard Deviation|Mean
739529|NCT00468481|Post-Hoc|Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 20|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|up to week 20|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||nmol/L||Standard Deviation|Mean
739530|NCT00468481|Post-Hoc|Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 16|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|up to week 16|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||nmol/L||Standard Deviation|Mean
739531|NCT00468481|Post-Hoc|Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 16|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|up to week 16|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||nmol/L||Standard Deviation|Mean
739532|NCT00468481|Post-Hoc|Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 12|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|up to week 12|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||nmol/L||Standard Deviation|Mean
739533|NCT00468481|Post-Hoc|Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 12|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|up to week 12|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||nmol/L||Standard Deviation|Mean
739534|NCT00468481|Post-Hoc|Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 8|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|up to week 8|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||nmol/L||Standard Deviation|Mean
739535|NCT00468481|Post-Hoc|Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 8|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|up to week 8|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||nmol/L||Standard Deviation|Mean
739536|NCT00468481|Post-Hoc|Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 4|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|up to week 4|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||nmol/L||Standard Deviation|Mean
739537|NCT00468481|Post-Hoc|Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 4|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|up to week 4|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24||nmol/L||Standard Deviation|Mean
740175|NCT00462423|Secondary|Objective Response Rate (RR) in Patients With Measurable Lesions Time to Objective Response|The objective response rate is defined as the percentage of patients showing complete or partial response.|The median duration of follow-up for surviving patients was 41.6 months.|||Percentage of participants||95% Confidence Interval|Number
739538|NCT00468481|Post-Hoc|Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Baseline|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|at baseline (week 0)|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24||nmol/L||Standard Deviation|Mean
739539|NCT00468481|Post-Hoc|Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Baseline|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|at baseline (week 0)|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24||nmol/L||Standard Deviation|Mean
739540|NCT00468481|Secondary|Mean Change From Baseline in Plasma Homocysteine Levels at Week 24|Homocysteine concentrations in plasma were determined by Fluorescence Polarization Immunoassays (FPIA) using the Abbot AxSym analyzer in a clinical laboratory setting.|baseline and up to week 24|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||µg/L||Standard Deviation|Mean
739541|NCT00468481|Secondary|Mean Change From Baseline in Plasma Homocysteine Levels at Week 20|Homocysteine concentrations in plasma were determined by Fluorescence Polarization Immunoassays (FPIA) using the Abbot AxSym analyzer in a clinical laboratory setting.|baseline and up to week 20|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||µg/L||Standard Deviation|Mean
739542|NCT00468481|Secondary|Mean Change From Baseline in Plasma Homocysteine Levels at Week 16|Homocysteine concentrations in plasma were determined by Fluorescence Polarization Immunoassays (FPIA) using the Abbot AxSym analyzer in a clinical laboratory setting.|baseline and up to week 16|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||µg/L||Standard Deviation|Mean
739543|NCT00468481|Secondary|Mean Change From Baseline in Plasma Homocysteine Levels at Week 12|Homocysteine concentrations in plasma were determined by Fluorescence Polarization Immunoassays (FPIA) using the Abbot AxSym analyzer in a clinical laboratory setting.|baseline and up to week 12|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||µg/L||Standard Deviation|Mean
739544|NCT00468481|Secondary|Mean Change From Baseline in Plasma Homocysteine Levels at Week 8|Homocysteine concentrations in plasma were determined by Fluorescence Polarization Immunoassays (FPIA) using the Abbot AxSym analyzer in a clinical laboratory setting.|baseline and up to week 8|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||µg/L||Standard Deviation|Mean
739545|NCT00468481|Secondary|Mean Change From Baseline in Plasma Homocysteine Levels at Week 4|Homocysteine concentrations in plasma were determined by Fluorescence Polarization Immunoassays (FPIA) using the Abbot AxSym analyzer in a clinical laboratory setting.|baseline and up to week 4|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24||µg/L||Standard Deviation|Mean
739546|NCT00468481|Secondary|Mean Change From Baseline in Plasma Folate Levels at Week 20|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|baseline and up to week 20|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||nmol/L||Standard Deviation|Mean
739547|NCT00468481|Secondary|Mean Change From Baseline in Plasma Folate Levels at Week 16|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|baseline and up to week 16|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||nmol/L||Standard Deviation|Mean
739548|NCT00468481|Secondary|Mean Change From Baseline in Plasma Folate Levels at Week 12|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|baseline and up to week 12|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||nmol/L||Standard Deviation|Mean
739549|NCT00468481|Secondary|Mean Change From Baseline in Plasma Folate Levels at Week 8|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|baseline and up to week 8|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24||µg/L||Standard Deviation|Mean
739550|NCT00468481|Secondary|Mean Change From Baseline in Plasma Folate Levels at Week 4|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|baseline and up to week 4|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24||nmol/L||Standard Deviation|Mean
739551|NCT00468481|Secondary|Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 20|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|baseline and up to week 20|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||nmol/L||Standard Deviation|Mean
739958|NCT00461305|Secondary|Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 6|Total pelvic pain score was defined as sum of 2 sub-scores: severity of dysmenorrhea and use of analgesics. Higher score means it is more severe. 0=None, 6=Severest.|Up to Cycle 6 (168 days) with 28 days per cycle|FAS (Participants with data at Cycle 6)||participants|||Number
739552|NCT00468481|Secondary|Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 16|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|baseline and up to week 16|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||nmol/L||Standard Deviation|Mean
739553|NCT00468481|Secondary|Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 12|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|baseline and up to week 12|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||nmol/L||Standard Deviation|Mean
739554|NCT00468481|Secondary|Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 8|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|baseline and up to week 8|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||nmol/L||Standard Deviation|Mean
739555|NCT00468481|Secondary|Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 4|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|baseline and up to week 4|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24||nmol/L||Standard Deviation|Mean
739556|NCT00468481|Secondary|Mean Neural Tube Defect (NTD) Risk Reduction at Week 24|The mean NTD risk reduction evaluated as the change from Baseline to Week 24 in NTD risk based on the formula of Daly et al (J Amer Med Assoc 1995;274(21):1698-702); NTD risk=exp (1.6463-1.2193 x natural log [RBC folate]) where natural log [RBC folate] is the natural log of RBC folate measured in nmol/L; Change from Baseline to Week 24 in NTD risk=NTD risk at Week 24 - NTD risk at Baseline|Baseline and week 24|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||per 1000 birth||Standard Deviation|Mean
739557|NCT00468481|Primary|Plasma Folate Level at 24 Weeks|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|Week 24|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||nmol/L||95% Confidence Interval|Least Squares Mean
739558|NCT00468481|Primary|Red Blood Cell (RBC) Folate Level at 24 Weeks|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|Week 24|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||nmol/L||95% Confidence Interval|Least Squares Mean
739559|NCT00468546|Secondary|Percentage of Participants Without Erosive Progression|The Genant-modified Sharp scoring system assesses structural damage due to rheumatoid arthritis in radiographs. A score for erosions of 0-3.5 (8 gradations) is assigned for 14 joints in each hand and wrist, and 6 joints in each foot. The maximum erosion score is 40 x 3.5 = 140 which is normalized to 145. The minimum score is 0 and the maximum score is 145. A higher score indicates more damage and negative change score indicates improvement.|Up to Week 104|ITT population included all randomized participants who received any part of an infusion of study medication. Participants with available data at the time of evaluation were analyzed.||percentage of participants|||Number
739560|NCT00468546|Secondary|Mean Change From Baseline in the Genant-modified Sharp Joint Space Narrowing Score, Genant-modified Sharp Total Score, and Erosion Score|The Genant-modified Sharp scoring system assesses structural damage due to rheumatoid arthritis in radiographs. A score for erosions of 0-3.5 (8 gradations) is assigned for 14 joints in each hand and wrist, and 6 joints in each foot. Joint space narrowing scores of 0-4 (9 gradations) are assigned to 13 joints in each hand and 6 joints in each foot. The maximum erosion score is 40 x 3.5 = 140. The maximum joint space narrowing score is 38 x 4.0 = 152. Both the erosion and joint space narrowing scores are normalized to 145 and are added together for a maximum total Genant-modified Sharp score of 290. For all the three radiograph assessment, the minimum score is 0. A higher score indicates more damage and a negative change score indicates improvement. The change in score is to be calculated as: Change from Baseline = difference between the score at Weeks 24, 56, or 104 and the score at Baseline.|From Baseline (Day 1) to Weeks (W) 24, 56, and 104|The ITT population included all randomized participants who received any part of an infusion of study drug. Participants whom treatment allocation was unblinded and who received treatment prior to randomization were excluded.||units on a scale||Standard Deviation|Mean
739561|NCT00468546|Secondary|Number of Participants With Change From Baseline in the Mental Component Scores of SF-36|The SF-36 determined participants’ overall quality of life by assessing :1) limitations in physical functioning due to health problems; 2) limitations in usual daily activities because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems since last month; 7) limitations in usual work (house hold and outside) due to emotional problems 8) current and 1 year past status of health 9) general mental health. Scores on mental component were summed and averaged (range = 0 [worst]-100 [best]); increase from baseline indicated improvement. If participants’ had shown change from baseline in mental health score >6.33, it was considered as improved; scores between -6.33 to 6.33 was considered unchanged, and score <-6.33 was considered as worsened. Change from Baseline = difference between the mental component score at Week 24 and the score at Baseline.|From Baseline (Day 1) to Week 24|The ITT population included all randomized participants who received any part of an infusion of study drug. Participants with available data at the time of evaluation were analyzed.||participants|||Number
739645|NCT00468819|Secondary|Number of Participants With Basic Technical Adequacy of Magnetic Resonance (MR) Images for Diagnosis by Age Group|In the participants the technical adequacy (evaluability) of MR images was assessed on the following 4-point scale (1=not adequate [compromised quality], 2=partially adequate [evaluation possible], 3=adequate despite artifacts, 4=adequate with excellent quality).|Up to 1 hour after Gadobutrol injection|FAS||Participants|||Number
740001|NCT00461630|Secondary|Major Coronary Events|Non-fatal myocardial infarction (MI) or coronary death|During scheduled treatment period (median duration 3.9 years)|||participants|||Number
739562|NCT00468546|Secondary|Number of Participants With Categorical Change From Baseline in the Physical Component Scores of SF-36|The SF-36 determined participants’ overall quality of life by assessing :1) limitations in physical functioning due to health problems; 2) limitations in usual daily activities because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems since last month; 7) limitations in usual work (house hold and outside) due to emotional problems 8) current and 1 year past status of health 9) general mental health. Scores on physical component were summed and averaged (range 0 [worst] to 100 [best]); If participants’ had shown change from baseline in physical health component score >5.42, it was considered as improved; score between -5.42 to 5.42 was considered as unchanged, and score < -5.42 was considered as worsened. Change from Baseline = difference between the score of physical component at Week 24 and the score at Baseline.|From Baseline (Day 1) to Week 24|The ITT population included all randomized participants who received any part of an infusion of study drug. Participants with available data at the time of evaluation were analyzed.||participants|||Number
739563|NCT00468546|Secondary|Mean Change From Baseline of Short Form 36 Total Scores at Week 24|The Short Form (SF)-36 determined participants’ overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual daily activities because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems since last month; 7) limitations in usual work (house hold and outside) due to emotional problems 8) current and 1 year past status of health 9) general mental health. Transforming and standardizing these domains leads to the calculation of the physical component summary and mental component summary measures. Scores on each item were summed and averaged (range 0 [worst] to 100 [best]); increase in score from baseline indicated improvement. Change from Baseline = difference between the score at Week 24 and the score at Baseline.|From Baseline (Day 1) to Week 24|The ITT population included all randomized participants who received any part of an infusion of study drug. Participants with available data at the time of evaluation were analyzed.||units on a scale||Standard Deviation|Mean
739564|NCT00468546|Secondary|Percentage Change From Baseline in the ACR Core Set (SJC, TJC, Patient’s and Physician’s Global Assessments, Health Assessment Questionnaire, Pain, C-Reactive Protein, and Erythrocyte Sedimentation Rate) Score|Percentage change in the scores of the following parameters of ACR core set relative to respective baseline scores in both study arms was analyzed : SJC (28 and 66 joints) and TJC (28 and 66 joints), patient’s global assessment and physician’s global assessment based on disease activity (both are expressed by VAS [0 = no disease activity to 100 = maximum disease activity]), HAQ (based on HAQ disability index [HAQDI]) which included 8 domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities) rated on a 4-point scale (0=without any difficulty to 3=unable to do), where the sum of scores was divided by the number of domains with a score for a total possible score of 0 (best) to 3 (worst), pain assessment using a VAS ranging from score 0 (no pain) to 100 (unbearable pain), CRP concentration, and ESR.|From Baseline (Day 1) to Week 24|The ITT population included all randomized participants who received any part of an infusion of study drug. Participants whom treatment allocation was unblinded and who received treatment prior to randomization were excluded.||percent change||Standard Deviation|Mean
739565|NCT00468546|Secondary|Number of Participants With Good, Moderate, or no European League Against Rheumatism Responses at Week 24|European League Against Rheumatism (EULAR) response is defined based on the DAS28 score and the EULAR response criteria (Van Gestel et al, 1996 and 1999). The DAS28 scale ranges from score of 0 to 10, where lower scores indicate best disease control and higher scores indicate worsening of disease. At a given visit, participants with a DAS28 score of < 3.2 are considered good responders if the change from baseline in their DAS28 score is >1.2. Participants with a DAS28 score >= 3.2 to 5.1 are considered moderate responders if the change from baseline in their DAS28 score is <=1.2 to >=0.6. Participants with DAS28 score >5.1 are considered non-responders if the change from baseline in their DAS28 score is <=1.2 to >=0.6.|Week 24|The ITT population included all randomized participants who received any part of an infusion of study drug. Participants whom treatment allocation was unblinded and who received treatment prior to randomization were excluded.||participants|||Number
739566|NCT00468546|Secondary|Percentage of Participants With DAS28 Low Disease Activity and DAS28 Remission at Week 24|The DAS28 is an evaluation index of RA. The DAS28 applies a mathematical formula based on the following parameters: 1. TJC- 28 joints, 2. SJC- 28 joints, 3. ESR or CRP measurement, 4. Participant’s judgement on his own overall health status (GH) expressed by a visual analogue scale VAS (0 [no disease activity] to 100 [maximum disease activity]). The mathematical formula is 0.56 × √28TJC + 0.28 × √28SJC + 0.7 x loge ESR + 0.014 × GH. The DAS28 scale ranges from score of 0 to 10. A participant was categorized as having low disease activity, if participant’s DAS28 score was <= 3.2, and was categorized as having clinical remission if participant’s DAS28 score was < 2.6.|Week 24|The ITT population included all randomized participants who received any part of an infusion of study drug. Participants whom treatment allocation was unblinded and who received treatment prior to randomization were excluded.||percentage of participants|||Number
739567|NCT00468546|Secondary|Mean Change From Baseline in Disease Activity Score of 28 Joints at Week 24|The disease activity score (DAS28) is an evaluation index of rheumatoid arthritis. The DAS28 applies a mathematical formula based on the following parameters: 1. TJC-28 joints, 2. SJC -28 joints, 3. ESR or CRP measurement, 4. Participant’s judgement on his own overall health (global health [GH]) status expressed by a VAS (0 [no disease activity] to 100 [maximum disease activity]). The mathematical formula is 0.56 × √28TJC + 0.28 × √28SJC + 0.7 x loge ESR + 0.014 × GH. The DAS28 scale ranges from score of 0 to 10, where lower scores indicate best disease control and higher scores indicate worsening of disease. Change from Baseline = difference between the score at Week 24 and the score at Baseline.|From Baseline (Day 1) to Week 24|The ITT population included all randomized participants who received any part of an infusion of study drug. Participants whom treatment allocation was unblinded and who received treatment prior to randomization were excluded.||units on a scale||Standard Deviation|Mean
739646|NCT00468819|Secondary|Urinary Excretion of Gadolinium as Percent of Administered Dose|Amount of gadolinium* excreted into urine during the collection interval 0 - 6 h post dose expressed as % of administered dose. *A metallic rare-earth element, used as a contrast medium for magnetic resonance imaging.|up to 6 hours after Gadobutrol injection|Valid for urinary analysis||percentage of administered dose||Full Range|Mean
739568|NCT00468546|Secondary|Number of Participants With ACR 70 Response at Week 24|ACR 70 response is defined as a >= 70% improvement (reduction) in score compared with baseline for both TJC -68 joints and SJC -66 joints, as well as for 3 of the additional 5 ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a VAS ranging from score '0'=no pain to score '100'=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS ranging from score '0'=no disease activity to score '100'=maximum disease activity; HAQ : Health Assessment Questionnaire (HAQ):which included 8 domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities) rated on a 4-point scale (0=without any difficulty to 3=unable to do), where the sum of scores was divided by the number of domains with a score for a total possible score of 0 (best) to 3 (worst); and acute-phase reactant, either CRP or ESR.|Week 24|The ITT population included all randomized participants who received any part of an infusion of study drug. Participants whom treatment allocation was unblinded and who received treatment prior to randomization were excluded.||participants|||Number
739569|NCT00468546|Secondary|Number of Participants With an ACR 50 Response at Week 24|ACR 50 response is defined as a >= 50% improvement (reduction) in score compared with baseline for both TJC -68 joints and SJC -66 joints, as well as for 3 of the additional 5 ACR core set variables: Patient’s Assessment of Pain over the previous 24 hours: using a VAS ranging from score '0'=no pain to score '100'=unbearable pain; Patient’s Global Assessment of Disease Activity and Physician’s Global Assessment of Disease Activity over the previous 24 hours using a VAS ranging from score '0'=no disease activity to score '100'=maximum disease activity; HAQ : Health Assessment Questionnaire (HAQ):which included 8 domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities) rated on a 4-point scale (0=without any difficulty to 3=unable to do), where the sum of scores was divided by the number of domains with a score for a total possible score of 0 (best) to 3 (worst); and acute-phase reactant, either CRP or ESR.|Week 24|The ITT population included all randomized participants who received any part of an infusion of study drug. Participants whom treatment allocation was unblinded and who received treatment prior to randomization were excluded.||participants|||Number
739570|NCT00468546|Primary|Number of Participants With American College of Rheumatology 20 Response at Week 24|American College of Rheumatology (ACR) 20 response is defined as >= 20% improvement (reduction) in score compared with baseline for both tender joint count (TJC)-68 joints and swollen joint count (SJC)-66 joints, as well as for 3 of the additional 5 ACR core set variables: Patient’s Assessment of Pain over the previous 24 hours using a Visual Analog Scale (VAS) ranging from score 0 (no pain) to 100 (unbearable pain); Patient’s Global Assessment of Disease Activity and Physician’s Global Assessment of Disease Activity over the previous 24 hours using a VAS ranging score 0 (no disease activity) to 100 (maximum disease activity); Health Assessment Questionnaire (HAQ):8 domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities) rated on a 4-point scale (0=without any difficulty to 3=unable to do) for a total possible score of 0 (best) to 3 (worst); and acute-phase reactant, either C-reactive protein (CRP) or erythrocyte sedimentation rate (ESR).|Week 24|Intent to treat (ITT) population included all randomized participants who received any part of an infusion of study drug. Participants whom treatment allocation was unblinded and who received treatment prior to randomization were excluded.||participants|||Number
739571|NCT00468559|Secondary|Severity of Feeding Difficulties as Reported by Parent/Guardian (Open-label Phase Endpoint)|Symptom severity (Severity is scored as 0-4 [none, mild moderate, severe]). For each participant, The score is the mean severity in each 7-day period.|Open Label Phase (Screening plus two weeks)|83 patients were analyzed at the screening timepoint, 83 patients were analyzed at week 1 and 78 patients were analyzed at Week 2 due to discontinuations.||Units on a scale||Standard Deviation|Mean
739572|NCT00468559|Secondary|Severity of Supraesophageal/Respiratory Disturbances (Coughing/Wheezing,Labored Breathing) as Reported by Parent/Guardian (Open-label Phase Endpoint)|Symptom severity (Severity is scored as 0-4 [none, mild moderate, severe]). For each participant, The score is the mean severity in each 7-day period.|Open Label Phase (Screening plus two weeks)|84 patients were analyzed at the screening timepoint, 84 patients were analyzed at week 1 and 79 patients were analyzed at Week 2 due to discontinuations.||Units on a scale||Standard Deviation|Mean
739573|NCT00468559|Secondary|Severity of Irritability Crying/Fussing Symptoms as Reported by the Parent/Guardian (Open-label Phase Endpoint)|Symptom severity (Severity is scored as 0-4 [none, mild moderate, severe]). For each participant, The score is the mean severity in each 7-day period.|Open Label Phase (Screening plus two weeks)|84 patients were analyzed at the screening timepoint, 84 patients were analyzed at week 1 and 79 patients were analyzed at Week 2 due to discontinuations.||Units on a scale||Standard Deviation|Mean
739574|NCT00468559|Secondary|Severity of Vomiting/Regurgitation Symptoms as Reported by the Parent/Guardian (Open-label Phase)|Symptom severity (Severity is scored as 0-4 [none, mild moderate, severe]). For each participant, The score is the mean severity in each 7-day period.|Open Label phase (Screening plus two weeks)|84 patients were analyzed at the screening timepoint, 84 patients were analyzed at week 1 and 79 patients were analyzed at Week 2 due to discontinuations.||Units on a scale||Standard Deviation|Mean
739575|NCT00468559|Secondary|Improvement in Physician's Global Assessment (PGA) Following Open-label Esomeprazole (Open-label Phase Endpoint)|Number of patients who had an improvement of at least one category in the PGA at the end of open-label treatment with esomeprazole compared to baseline. Improvement in PGA was a pre-requisite for randomization into the randomized treatment withdrawal phase. Only patients with PGA at baseline and end of open-label are analyzed here.|Open-label treatment period (2 weeks)|95 patients received open-label esomeprazole during the open-label phase.||Participants|||Number
739576|NCT00468559|Secondary|Severity of Feeding Difficulties Reported by Parent/Guardian (Treatment Withdrawal Phase Endpoint)|Change from baseline in symptom severity (Severity is scored as 0-4 [none, mild moderate, severe]). For each participant, final severity score is the mean severity in the final 7-days, while baseline is the mean severity in the 7-day period up to and including randomization. Changes less than zero indicate improved severity versus baseline. Participants needed baseline measure and one additional post baseline measure to be included in analysis.|Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study) Change was calculated from baseline to last measure obtained|||Units on a scale||Standard Deviation|Mean
740002|NCT00461630|Primary|Major Vascular Event|Non-fatal myocardial infarction or coronary death, non-fatal or fatal stroke, or revascularisation|During scheduled treatment period (median duration 3.9 years)|||participants|||Number
739577|NCT00468559|Secondary|Severity of Supraesophageal/Respiratory Disturbances (Coughing/Wheezing,Labored Breathing) as Reported by Parent/Guardian (Treatment Withdrawal Phase Endpoint)|Change from baseline in symptom severity (Severity is scored as 0-4 [none, mild moderate, severe]). For each participant, final severity score is the mean severity in the final 7-days, while baseline is the mean severity in the 7-day period up to and including randomization. Changes less than zero indicate improved severity versus baseline. Participants needed baseline measure and one additional post baseline measure to be included in analysis.|Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study) Change was calculated from baseline to last measure obtained|||Units on a scale||Standard Deviation|Mean
739578|NCT00468559|Secondary|Severity of Irritability Crying/Fussing Symptoms as Reported by the Parent/Guardian (Treatment Withdrawal Phase Endpoint)|Change from baseline in symptom severity (Severity is scored as 0-4 [none, mild moderate, severe]). For each participant, final severity score is the mean severity in the final 7-days, while baseline is the mean severity in the 7-day period up to and including randomization. Changes less than zero indicate improved severity versus baseline. Participants needed baseline measure and one additional post baseline measure to be included in analysis.|Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study) Change was calculated from baseline to last measure obtained|||Units on a scale||Standard Deviation|Mean
739579|NCT00468559|Secondary|Severity of Vomiting/Regurgitation Symptoms as Reported by the Parent/Guardian (Treatment Withdrawal Phase Endpoint)|Change from baseline in symptom severity (Severity is scored as 0-4 [none, mild moderate, severe]). For each participant, final severity score is the mean severity in the final 7-days, while baseline is the mean severity in the 7-day period up to and including randomization. Changes less than zero indicate improved severity versus baseline. Participants needed baseline measure and one additional post baseline measure to be included in analysis.|Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study) Change was calculated from baseline to last measure obtained|||Units on a scale||Standard Deviation|Mean
739580|NCT00468559|Secondary|Physician's Global Assessment (PGA) of Gastroesophageal Reflux Disease (GERD) Symptoms (Treatment Withdrawal Phase Endpoint)|Percentage of participants with Physician's Global Assessment (PGA) score at the final treatment withdrawal assessment in following categories: None (no symptoms), Mild, Moderate or Severe. The worst post-randomization Physician's Global Assessment (PGA) assessment during double blind phase is taken into account.|Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study)|||Percentage of participants|||Number
739581|NCT00468559|Secondary|Treatment Successes at the End of the 4-week Double-blind Treatment Withdrawal Phase (Treatment Withdrawal Phase Endpoint).|"The number of participants reaching the end of the treatment withdrawal phase without discontinuing from the study (for any reason) or showing symptom worsening in the physician global assessment of Gastroesophageal Reflux Disease (GERD) symptoms. Based on the severity of symptoms reported by the parent/guardian in IVRS, the investigator provided the overall clinical impression of the patient’s GERD-related symptoms over the last 7 days as:
None Mild Moderate Severe"|Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study)|||Participants|||Number
739582|NCT00468559|Secondary|Number of Participants Discontinuing Due to Any Reason, Including Symptom Worsening, in the Randomized Treatment Withdrawal Phase (Treatment Withdrawal Phase Endpoint)|Number of participants discontinuing due to any reason was identical to the number of participants discontinuing due to symptom worsening (the primary assessment) when no participants discontinued due to reason other than symptom worsening.|Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study)|Reporting cumulative discontinuations. Results for the analysis of the secondary variable, time to discontinuation due to any cause, were identical to that found for the primary variable, time to discontinuation due to symptom.||Participants|||Number
739583|NCT00468559|Primary|Number of Participants Discontinuing Due to Symptom Worsening in the Randomized Treatment Withdrawal Phase (Treatment Withdrawal Phase Endpoint)|Number of participants discontinuing during the 4-week of randomized double-blind withdrawal phase that met the pre-set definition of symptom worsening criteria.|Treatment-withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study)|reporting cumulative discontinuations||Participants|||Number
739584|NCT00468585|Primary|Overall Objective Response|This is defined as the percentage of patients who achieve either an objective complete or partial target lesion response that is confirmed based on the RECIST criteria.|2 years|||participants|||Number
739585|NCT00468650|Secondary|Mean Per-Patient Percentage of Grade 3 or 4 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Week 2|Mean change: mean change at each visit minus mean at Week 2. Percent of Grade 3 (hard enough for penetration [but not completely hard]) or 4 (completely hard) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 3 or 4)/ (number of occasions where Erection Hardness Scale was answered)|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.||per-patient percentage||Standard Deviation|Mean
739586|NCT00468650|Secondary|Mean Per-Patient Percentage of Grade 3 or 4 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Baseline|Mean change: mean change at each visit minus mean at baseline. Percent of Grade 3 (hard enough for penetration [but not completely hard]) or 4 (completely hard) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 3 or 4)/ (number of occasions where Erection Hardness Scale was answered)|Week 2, Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.||per-patient percentage||Standard Deviation|Mean
739647|NCT00468819|Primary|Mean Residence Time (MRT) Estimates of Gadobutrol by Age Group|Mean residence time of Gadobutrol in plasma expressed in h.|From injection to 8 hours after Gadobutrol injection|Final PK analysis set||hours||Inter-Quartile Range|Median
739587|NCT00468650|Secondary|Mean Per-Patient Percentage of Grade 4 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Week 2|Mean change: mean change at each visit minus mean at Week 2. Percent of Grade 4 (4= completely hard) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 4)/(number of occasions where Erection Hardness Scale was answered)|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2||per-patient percentage||Standard Deviation|Mean
739588|NCT00468650|Secondary|Mean Per-Patient Percentage of Grade 4 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Baseline|Mean change: mean change at each visit minus mean at baseline. Percent of Grade 4 (4= completely hard) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 4)/(number of occasions where Erection Hardness Scale was answered)|Week 2, Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2||per-patient percentage||Standard Deviation|Mean
739589|NCT00468650|Secondary|Mean Per-Patient Percentage of Grade 3 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Week 2|Mean change: mean change at each visit minus mean at Week 2. Percent of Grade 3 (3= hard enough for penetration [but not completely hard]) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 3)/(number of occasions where Erection Hardness Scale was answered)|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.||per-patient percentage||Standard Deviation|Mean
739590|NCT00468650|Secondary|Mean Per-Patient Percentage of Grade 3 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Baseline|Mean change: mean change at each visit minus mean at baseline. Percent of Grade 3 (3= hard enough for penetration [but not completely hard]) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 3)/(number of occasions where Erection Hardness Scale was answered)|Week 2, Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.||per-patient percentage||Standard Deviation|Mean
739591|NCT00468650|Secondary|Mean Per-Patient Percentage of Grade 2 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Week 2|Mean change: mean change at each visit minus mean at Week 2. Percent of Grade 2 (2= hard, but not hard enough for penetration) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 2)/(number of occasions where Erection Hardness Scale was answered)|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.||per-patient percentage||Standard Deviation|Mean
739592|NCT00468650|Secondary|Mean Per-Patient Percentage of Grade 2 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Baseline|Mean change: mean change at each visit minus mean at baseline. Percent of Grade 2 (2= hard, but not hard enough for penetration) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 2)/(number of occasions where Erection Hardness Scale was answered)|Week 2, Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2||Per-patient percentage||Standard Deviation|Mean
739593|NCT00468650|Secondary|Mean Per-Patient Percentage of Grade 1 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation- Change From Week 2|Mean change: mean change at each visit minus mean at Week 2. Percent of Grade 1 (1=increase in size, but not hard) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 1)/(number of occasions where Erection Hardness Scale was answered)|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.||per-patient percentage||Standard Deviation|Mean
739594|NCT00468650|Secondary|Mean Per-Patient Percentage of Grade 1 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation- Change From Baseline|Mean change: mean change at each visit minus mean at baseline. Percent of Grade 1 (1=increase in size, but not hard) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 1)/(number of occasions where Erection Hardness Scale was answered)|Week 2, Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2||per-patient percentage||Standard Deviation|Mean
739648|NCT00468819|Primary|Terminal Elimination Half Life Estimates of Gadobutrol by Age Group|Terminal elimination half-life of Gadobutrol from plasma expressed in h and derived from the terminal slope of the concentration versus time curve.|From injection to 8 hours after Gadobutrol injection|Final PK analysis set||hours||Inter-Quartile Range|Median
739649|NCT00468819|Primary|Area Under the Drug Concentration-time Curve of Gadobutrol by Age Group|Area under the concentration versus time curve from zero to infinity after intravenous injection expressed in µmol*h/L.|From injection to 8 hours after Gadobutrol injection|Final PK analysis set||µmol*h/L||Inter-Quartile Range|Median
739595|NCT00468650|Secondary|Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 3 (Q3) Based on Attempts With Sexual Stimulation- Change From Week 2|Mean change: mean change at each visit minus mean at Week 2. Percent of “Yes” responses to SEP Q3 based on attempts with sexual stimulation (SS): 100* (number of attempts with SS where SEP Q3 [Did your erection last long enough for you to have successful intercourse?] = Yes)/(number of attempts with SS where SEP Q3 was answered Yes or No)|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.||per-patient percentage||Standard Deviation|Mean
739596|NCT00468650|Secondary|Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 3 (Q3) Based on Attempts With Sexual Stimulation- Change From Baseline|Mean change: mean change at each visit minus mean at baseline. Percent of “Yes” responses to SEP Q3 based on attempts with sexual stimulation (SS): 100* (number of attempts with SS where SEP Q3 [Did your erection last long enough for you to have successful intercourse?] = Yes)/(number of attempts with SS where SEP Q3 was answered Yes or No)|Week 2, Week 4, and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.||per-patient percentage||Standard Deviation|Mean
739597|NCT00468650|Secondary|Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 5 Based on Occasions With Sexual Stimulation- Change From Week 2|Mean change: mean change at each visit minus mean at Week 2. Percent of “Yes” responses to SEP Question 5 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 5 [“Were you satisfied with this sexual encounter?”] = “Yes”) / (number of occasions where SEP Question 5 was answered “Yes” or “No”)|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.||per-patient percentage||Standard Deviation|Mean
739598|NCT00468650|Secondary|Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 5 Based on Occasions With Sexual Stimulation- Change From Baseline|Mean change: mean change at each visit minus mean at baseline. Percent of “Yes” responses to SEP Question 5 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 5 [“Were you satisfied with this sexual encounter?”] = “Yes”) / (number of occasions where SEP Question 5 was answered “Yes” or “No”)|Week 2, Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2||per-patient percentage||Standard Deviation|Mean
739599|NCT00468650|Secondary|Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 4 Based on Occasions With Sexual Stimulation- Change From Week 2|Mean change: mean change at each visit minus mean at Week 2. Percent of “Yes” responses to SEP Question 4 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 4 [“Were you satisfied with the hardness of your erection?”] = “Yes”) / (number of occasions where SEP Question 4 was answered “Yes” or “No”).|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.||per-patient percentage||Standard Deviation|Mean
739600|NCT00468650|Secondary|Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 4 Based on Occasions With Sexual Stimulation- Change From Baseline|Mean change: mean change at each visit minus mean at baseline. Percent of “Yes” responses to SEP Question 4 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 4 [“Were you satisfied with the hardness of your erection?”] = “Yes”) / (number of occasions where SEP Question 4 was answered “Yes” or “No”).|Week 2, Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.||per-patient percentage||Standard Deviation|Mean
739601|NCT00468650|Secondary|Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 3 Based on Occasions With Sexual Stimulation- Change From Week 2|Mean change: mean change at each visit minus mean at Week 2. Percent of “Yes” responses to SEP Question 2 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 3 [Did your erection last long enough for you to have successful intercourse?] = Yes) / (number of occasions where SEP Question 3 was answered Yes or No)|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.||per-patient percentage||Standard Deviation|Mean
739602|NCT00468650|Secondary|Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 3 on Occasions With Sexual Stimulation- Change From Baseline|Mean change: mean change at each visit minus mean at baseline. Percent of “Yes” responses to SEP Question 2 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 3 [Did your erection last long enough for you to have successful intercourse?] = Yes) / (number of occasions where SEP Question 3 was answered Yes or No)|Week 2, Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2||per-patient percentage||Standard Deviation|Mean
739603|NCT00468650|Secondary|Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 2 on Occasions With Sexual Stimulation- Change From Week 2|Mean change: mean change at each visit minus mean at Week 2. Percent of “Yes” responses to SEP Question 2 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 2 [“Were you able to insert your penis into your partner’s vagina?”] = “Yes”) / (number of occasions where SEP Question 2 was answered “Yes” or “No”).|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.||per-patient percentage||Standard Deviation|Mean
739604|NCT00468650|Secondary|Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 2 on Occasions With Sexual Stimulation- Change From Baseline|Mean change: mean change at each visit minus mean at baseline. Percent of “Yes” responses to SEP Question 2 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 2 [“Were you able to insert your penis into your partner’s vagina?”] = “Yes”) / (number of occasions where SEP Question 2 was answered “Yes” or “No”).|Week 2, Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.||per-patient percentage||Standard Deviation|Mean
739605|NCT00468650|Secondary|Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 1 Based on Occasions With Sexual Stimulation- Change From Week 2|Mean change: mean change at each visit minus mean at Week 2. Percent of “Yes” responses to Question 1 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 1 [Were you able to achieve at least some erection (some enlargement of the penis)?] = Yes) / (number of occasions where Question 1 was answered Yes or No)|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.||per-patient percentage||Standard Deviation|Mean
739606|NCT00468650|Secondary|Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 1 on Occasions With Sexual Stimulation- Change From Baseline|Mean change: mean change at each visit minus mean at baseline. Percent of “Yes” responses to Question 1 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 1 [Were you able to achieve at least some erection (some enlargement of the penis)?] = Yes) / (number of occasions where Question 1 was answered Yes or No)|Week 2, Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.||per-patient percentage||Standard Deviation|Mean
739607|NCT00468650|Secondary|Sexual Experience Questionnaire (Sex-Q): Relationship Domain - Change From Week 2|Sexual Experience Questionnaire (Sex-Q) is a self-administered questionnaire designed to assess functional, emotional, and social aspects of sexual experience. Sex-Q includes 15 questions. Sex-Q Relationship domain was sum of scores for Questions 7, 8 and 9 from the Sex-Q. Score range: 1 to 5; total 3 to 15. Higher score indicates better outcome.|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2||score on scale||Standard Deviation|Mean
739608|NCT00468650|Secondary|Sexual Experience Questionnaire (Sex-Q): Relationship Domain - Change From Baseline|Sexual Experience Questionnaire (Sex-Q) is a self-administered questionnaire designed to assess functional, emotional, and social aspects of sexual experience. Sex-Q includes 15 questions. Sex-Q Relationship domain was sum of scores for Questions 7, 8 and 9 from the Sex-Q. Score range: 1 to 5; total 3 to 15. Higher score indicates better outcome.|Week 2, Week 4, and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2||score on scale||Standard Deviation|Mean
739609|NCT00468650|Secondary|Sexual Experience Questionnaire (Sex-Q): Satisfaction Domain - Change From Week 2|Sexual Experience Questionnaire (Sex-Q) is a self-administered questionnaire designed to assess functional, emotional, and social aspects of sexual experience. Sex-Q includes 15 questions (q). Sex-Q Satisfaction domain:sum of scores for q 10, 11, 12, 13, 14 and 15 from Sex-Q. Score range:1 to 5; total 6 to 30. Higher score indicates better outcome|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2||score on scale||Standard Deviation|Mean
739610|NCT00468650|Secondary|Sexual Experience Questionnaire (Sex-Q): Satisfaction Domain - Change From Baseline|Sexual Experience Questionnaire (Sex-Q) is a self-administered questionnaire designed to assess functional, emotional, and social aspects of sexual experience. Sex-Q includes 15 questions (q). Sex-Q Satisfaction domain:sum of scores for q 10, 11, 12, 13, 14 and 15 from Sex-Q. Score range:1 to 5; total 6 to 30. Higher score indicates better outcome|Week 2, Week 4, and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2||score on scale||Standard Deviation|Mean
739650|NCT00468819|Primary|Body Weight-corrected Volume Distribution at Steady State (Vss) Estimates of Gadobutrol by Age Group|Apparent volume of distribution at steady state corrected for body weight (L/h/kg) after intravenous injection.|From injection to 8 hours after Gadobutrol injection|Final PK analysis set||L/kg||Inter-Quartile Range|Median
739611|NCT00468650|Secondary|Sexual Experience Questionnaire (Sex-Q): Erection Domain- Change From Week 2|Sexual Experience Questionnaire (Sex-Q) is a self-administered questionnaire designed to assess functional, emotional, and social aspects of sexual experience. Sex-Q includes 15 questions. Sex-Q Erection domain: sum of scores for Questions 1, 2, 3, 4, 5 and 6 from the Sex-Q. Score range: 1 to 5; total 6 to 30. Higher score indicates better outcome.|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2||score on scale||Standard Deviation|Mean
739612|NCT00468650|Secondary|Sexual Experience Questionnaire (Sex-Q): Erection Domain - Change From Baseline|Sexual Experience Questionnaire (Sex-Q) is a self-administered questionnaire designed to assess functional, emotional, and social aspects of sexual experience. Sex-Q includes 15 questions. Sex-Q Erection domain: sum of scores for Questions 1, 2, 3, 4, 5 and 6 from the Sex-Q. Score range: 1 to 5; total 6 to 30. Higher score indicates better outcome.|Week 2, Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2||score on scale||Standard Deviation|Mean
739613|NCT00468650|Secondary|Quality of Erection Questionnaire (QEQ): Total Score- Change From Week 2|QEQ is a self-administered scale used to assess erection hardness and overall quality of erections. The QEQ total score is defined as the sum of the scores from QEQ Questions 1-6. Score range: 1 to 5. Higher score indicates better outcome. Raw QEQ score ranges from 6-30 and is transformed onto a 0-100 scale.|Week 4 and Week 6|||score on scale||Standard Deviation|Mean
739614|NCT00468650|Secondary|Quality of Erection Questionnaire (QEQ): Total Score - Change From Baseline|QEQ is a self-administered scale used to assess erection hardness and overall quality of erections. The QEQ total score is defined as the sum of the scores from QEQ Questions 1-6. Score range: 1 to 5. Higher score indicates better outcome. Raw QEQ score ranges from 6-30 and is transformed onto a 0-100 scale.|Week 2, Week 4, and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2||score on scale||Standard Deviation|Mean
739615|NCT00468650|Secondary|International Index of Erectile Function (IIEF), Overall Satisfaction Domain Score- Change From Week 2|IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one is overall satisfaction. IIEF Overall Satisfaction Domain was sum of scores for Questions 13 and 14 from the IIEF. Score range: 1 to 5; total 2 to 10. Higher score indicates better outcome.|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2||score on scale||Standard Deviation|Mean
739616|NCT00468650|Secondary|International Index of Erectile Function (IIEF), Overall Satisfaction Domain Score- Change From Baseline|IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one is overall satisfaction. IIEF Overall Satisfaction Domain was sum of scores for Questions 13 and 14 from the IIEF. Score range: 1 to 5; total 2 to 10. Higher score indicates better outcome.|Week 2, Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2||score on scale||Standard Deviation|Mean
739617|NCT00468650|Secondary|International Index of Erectile Function (IIEF), Intercourse Satisfaction Domain Score- Change From Week 2|IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one is intercourse satisfaction. IIEF Intercourse Satisfaction Domain: sum of scores for Questions 6, 7 and 8 from IIEF. Score range: 0 to 5; total 0 to 15. Higher score indicates better outcome.|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2||score on scale||Standard Deviation|Mean
739618|NCT00468650|Secondary|International Index of Erectile Function (IIEF), Intercourse Satisfaction Domain Score- Change From Baseline|IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one is intercourse satisfaction. IIEF Intercourse Satisfaction Domain: sum of scores for Questions 6, 7 and 8 from IIEF. Score range: 0 to 5; total 0 to 15. Higher score indicates better outcome.|Week 2, Week 4, and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2||score on scale||Standard Deviation|Mean
739619|NCT00468650|Secondary|International Index of Erectile Function (IIEF), Sexual Desire Domain Score- Change From Week 2|IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one of which is sexual desire. IIEF Sexual Desire Domain was sum of scores for Questions 11 and 12 from the IIEF. Score range: 1 to 5; total 2 to 10. Higher score indicates better outcome.|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2||score on scale||Standard Deviation|Mean
739651|NCT00468819|Primary|Volume Distribution at Steady State (Vss) Estimates of Gadobutrol by Age Group|Apparent volume of distribution at steady state expressed in L after intravenous injection.|From injection up to 8 hours after Gadobutrol injection|Final PK analysis set||L||Inter-Quartile Range|Median
739620|NCT00468650|Secondary|International Index of Erectile Function (IIEF), Sexual Desire Domain Score- Change From Baseline|IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one of which is sexual desire. IIEF Sexual Desire Domain was sum of scores for Questions 11 and 12 from the IIEF. Score range: 1 to 5; total 2 to 10. Higher score indicates better outcome.|Week 2, Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2||score on scale||Standard Deviation|Mean
739621|NCT00468650|Secondary|International Index of Erectile Function (IIEF), Orgasmic Function Domain- Change From Week 2|IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one is orgasmic function. IIEF Orgasmic Function Domain was sum of scores for Questions 9 and 10 from the IIEF. Score range: 0 to 5; total 0 to 10. Higher score indicates better outcome.|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2||score on scale||Standard Deviation|Mean
739622|NCT00468650|Secondary|International Index of Erectile Function (IIEF), Orgasmic Function Domain- Change From Baseline|IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one is orgasmic function. IIEF Orgasmic Function Domain was sum of scores for Questions 9 and 10 from the IIEF. Score range: 0 to 5; total 0 to 10. Higher score indicates better outcome.|Week 2, Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2||score on scale||Standard Deviation|Mean
739623|NCT00468650|Secondary|International Index of Erectile Function (IIEF), Erectile Function (EF) Domain Score- Change From Week 2|IIEF is a self-administered scale designed to assess erectile functioning: includes 15 questions on 5 relevant domains of male sexual function; one is erectile function (EF). IIEF-EF Domain: sum of scores for Questions 1, 2, 3, 4, 5 & 15 from IIEF. Score range: 0 to 5 (Q1 to Q5), 1 to 5 (Q15); total 1 to 30. Higher score indicates better outcome.|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2||score on scale||Standard Deviation|Mean
739624|NCT00468650|Secondary|International Index of Erectile Function (IIEF), Erectile Function (EF) Domain Score - Change From Baseline at Weeks 2, 4 and 6|IIEF is a self-administered scale designed to assess erectile functioning: includes 15 questions on 5 relevant domains of male sexual function; one is erectile function (EF). IIEF-EF Domain: sum of scores for Questions 1, 2, 3, 4, 5 & 15 from IIEF. Score range: 0 to 5 (Q1 to Q5), 1 to 5 (Q15); total 1 to 30. Higher score indicates better outcome.|Week 2, Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. Week 6 Endpoint = last observation recorded after Week 2||score on a scale||Standard Deviation|Mean
739625|NCT00468650|Primary|International Index of Erectile Function (IIEF), Erectile Function (EF) Domain Score- Change From Baseline to Week 6 Last Observation Carried Forward (LOCF)|IIEF is a self-administered scale designed to assess erectile functioning: includes 15 questions on 5 relevant domains of male sexual function; one is erectile function (EF). IIEF-EF Domain: sum of scores for Questions 1, 2, 3, 4, 5 & 15 from IIEF. Score range: 0 to 5 (Q1 to Q5), 1 to 5 (Q15); total 1 to 30. Higher score indicates better outcome.|Week 6 LOCF|Modified intent to treat (MITT) population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, last assessment collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.||score on scale||Standard Deviation|Mean
739626|NCT00468676|Primary|Glycated Hemoglobin (HbA1c) at Baseline, 6 Months and 12 Months|"Glycated hemoglobin (HbA1c) was measured at Baseline, 6 months and 12 months
For the Primary Outcome (Outcome Measure #1 above), a scaled marginal model approach was used to jointly describe the four 12 month outcomes (SCL-20, HbA1c, systolic BP, LDL) and allowed use to test for a primary effect of the intervention among outcomes, scaling each outcome by its standard error, so the intervention effects could be interpreted as effect sizes."|Measured at Baseline, 6 months and 12 months|This was an intent to treat analysis of the 12 month SCL-20, HbA1c, LDL and systolic blood pressure outcomes||percent glycated hemoglobin||Standard Deviation|Mean
739627|NCT00468676|Primary|LDL Cholesterol at Baseline and 12 Months|"LDL Cholesterol was measured at Baseline and 12 months
For the Primary Outcome (Outcome Measure #1 above), a scaled marginal model approach was used to jointly describe the four 12 month outcomes (SCL-20, HbA1c, systolic BP, LDL) and allowed use to test for a primary effect of the intervention among outcomes, scaling each outcome by its standard error, so the intervention effects could be interpreted as effect sizes."|Measured at Baseline and 12 months|This was an intent to treat analysis of the 12 month SCL-20, HbA1c, LDL and systolic blood pressure outcomes||mg/dL||Standard Deviation|Mean
739628|NCT00468676|Primary|Systolic Blood Pressure at Baseline, 6 Months and 12 Months|"Systolic Blood Pressure was measured at Baseline, 6 months and 12 months
For the Primary Outcome (Outcome Measure #1 above), a scaled marginal model approach was used to jointly describe the four 12 month outcomes (SCL-20, HbA1c, systolic BP, LDL) and allowed use to test for a primary effect of the intervention among outcomes, scaling each outcome by its standard error, so the intervention effects could be interpreted as effect sizes."|Measured at Baseline, 6 Months, 12 months|This was an intent to treat analysis of the 12 month SCL-20, HbA1c, LDL and systolic blood pressure outcomes||mmHg||Standard Deviation|Mean
739652|NCT00468819|Primary|Body Weight-corrected Plasma Clearance Estimates of Gadobutrol by Age Group|Total body clearance of Gadobutrol in plasma corrected for body weight (L/h/kg) after intravenous injection.|From injection up to 8 hours after Gadobutrol injection|Final PK analysis set||L/h/kg||Inter-Quartile Range|Median
739629|NCT00468676|Primary|Symptom Checklist-20 Score at Baseline, 6 Months and 12 Months|"SCL-20 is a 20 question checklist in which items are averaged to yield a potential score of 0 to 4 with higher scores indicating more severe depression symptoms.
For the Primary Outcome (Outcome Measure #1 above), a scaled marginal model approach was used to jointly describe the four 12 month outcomes (SCL-20, HbA1c, systolic BP, LDL) and allowed use to test for a primary effect of the intervention among outcomes, scaling each outcome by its standard error, so the intervention effects could be interpreted as effect sizes."|Measured at Baseline, 6 Months, 12 months|This was an intent to treat analysis of the 12 month SCL-20, HbA1c, LDL and systolic blood pressure outcomes||scores on a scale||Standard Deviation|Mean
739630|NCT00468676|Secondary|Health Care Costs|Mean total outpatient costs for 2 years post baseline adjusted for age, gender and previous 12 months of outpatient costs|Cumulative outpatient costs over 24 months|||US dollars||Standard Deviation|Least Squares Mean
739631|NCT00468676|Secondary|Functional Impairment|"Disability was measured by the Sheehan Disability scale which measures the extent to which health interferes with social, vocational and familial functioning each on a 0 to 10 Likert scale where 0 is not at all and 10 is extremely. This scale consists of 3 items which are averaged together to create the average disability score, which ranges from 0 to 10."|Measured at Months 6, 12 months|||units on a scale||Standard Deviation|Mean
739632|NCT00468676|Primary|Combined Effect of Intervention on SCL-20, Systolic Blood Pressure, LDL and HbA1c|A scaled marginal model approach was used to jointly describe the four 12 month outcomes (SCL-20, HbA1c, systolic BP, LDL: all data submitted as Outcome Measures #2-5 below) and allowed use to test for a primary effect of the intervention among outcomes, scaling each outcome by its standard error, so the intervention effects could be interpreted as effect sizes.The model was estimated by iterating between estimation of the covariance associated with the outcomes and generalized-estimating equation estimation of scaled outcomes. Effect size is estimated as Cohen d effect size that was use for the depression outcome is the difference in change from baseline to 12 months in the intervention and usual care groups divided by the pooled base line standard deviation. Thus, a d of 0.25 indicates that one-quarter of a standard deviation separates the two means. Cohen has suggested that an effect size of 0.20 would be considered small, 0.50 medium and 0.80 large.|Baseline to 12 months|This was an intent to treat analysis of the 12 month SCL-20, HbA1c, LDL and systolic blood pressure outcomes||unitless||95% Confidence Interval|Number
739633|NCT00468728|Secondary|Global Cure|Achieving a cure response at end of treatment and not having a recurrence at any time up to the post-study visit.|End of Study|The analysis population is mITT, subjects that achieved a cure response at end of treatment and not having a recurrence at any time up to the Post-study visit.||Percentage of Participants|||Number
739634|NCT00468728|Secondary|Recurrence|Percentage of subjects with the re-establishment of diarrhea to an extent(based on frequency of passed unformed stools) that was greater than that noted on the last day of study medication, and the demonstration of either toxin A or B or both of C. difficile, and retreatment with CDI anti-infective therapy was needed.|Study days 11-40|The analysis population is mITT, for subjects who met the primary endpoint of cure, was analyzed for the recurrence rates of diarrhea up to the Poststudy Visit.||Percentage of Participants|||Number
739635|NCT00468728|Primary|Cure Rate at End of Therapy|Percentage of subjects with 3 or fewer unformed stools for 2 consecutive days and maintained through the end of therapy, and the subject no longer needed specific anti-Clostridium antibacterial treatment after completion of the course of study medication.|Study day 10 (+/- 2 days)|Analysis data is modified intent to treat (mITT) population. The mITT population consists of subjects that had CDAD confirmed by >3 unformed bowel movements in the 24 hours prior to randomization and a positive toxin assay and received at least one dose of study medication.||Percentage of Participants||95% Confidence Interval|Number
739636|NCT00468819|Secondary|Number of Participants With Change in Diagnostic Confidence by Age Group|In the participants the change in diagnostic confidence (additional diagnostic gain by the post-contrast scan) was assessed on the following 3-point scale (1=unchanged, 2=improved, 3=worsened).|up to 1 hour after Gadobutrol injection|FAS||Participants|||Number
739637|NCT00468819|Secondary|Degree of Contrast Enhancement in Lesion/Vessel by Age Group (Given Are Total Numbers of Lesions)|In the participants the degree of contrast enhancement in each lesion/vessel was assessed on the following 5-point scale (1=no, 2=moderate, 3=good, 4=excellent, 5=not applicable).|up to 1 hour after Gadobutrol injection|FAS||Lesions|||Number
739638|NCT00468819|Secondary|Post-Contrast Lesion Characterization by Age Group|In the participants the internal morphology and structure of each post-contrast lesion was assessed on the following 4-point scale (1=poor, 2=moderate, 3=good, 4=not applicable).|up to 1 hour after Gadobutrol injection|FAS||Lesions|||Number
739639|NCT00468819|Secondary|Pre-Contrast Lesion Characterization by Age Group|In the participants the internal morphology and structure of each pre-contrast lesion was assessed on the following 4-point scale (1=poor, 2=moderate, 3=good, 4=not applicable).|up to 1 hour after Gadobutrol injection|FAS||Lesions|||Number
739640|NCT00468819|Secondary|Post-Contrast Delineation of Lesion/Vessel Border by Age Group|In the participants post-contrast delineation of each lesion/vessel border was assessed on the following 5-point scale (no, moderate, good, excellent, not assessable).|up to 1 hour after Gadobutrol injection|FAS||Lesions|||Number
739641|NCT00468819|Secondary|Pre-Contrast Delineation of Lesion/Vessel Border by Age Group|In the participants pre-contrast delineation of each lesion/vessel border was assessed on the following 5-point scale (no, moderate, good, excellent, not assessable).|up to 1 hour after Gadobutrol injection|FAS||Lesions|||Number
739642|NCT00468819|Secondary|Post-Contrast Lesions by Location and by Age Group|Number of lesions on post-contrast images by organ location and age group.|up to 1 hour after Gadobutrol injection|FAS||Lesions|||Number
739643|NCT00468819|Secondary|Pre-Contrast Lesions by Location and by Age Group|Number of lesions on pre-contrast images by organ location and age group.|up to 1 hour after Gadobutrol injection|FAS||Lesions|||Number
739644|NCT00468819|Secondary|Number of Participants With Overall Contrast Quality of Post Contrast Images by Age Group|In the participants qualitative overall contrast quality of post contrast images was assessed on the following 6-point scale (none, poor, moderate, good, excellent, not assessable).|up to 1 hour after Gadobutrol injection|FAS||Participants|||Number
739653|NCT00468819|Primary|Plasma Clearance Estimates of Gadobutrol by Age Group|Total body clearance of Gadobutrol in plasma in L/h after intravenous injection.|From injection of Gadobutrol up to 8 hours after injection.|Final pharmacokinetics (PK) analysis set||L/h||Inter-Quartile Range|Median
739654|NCT00468845|Secondary|Total Clinically Meaningful Event (CME) Score|Total CME score calculated by summing the number of Clinically Meaningful Events (CMEs) across symptoms. CME for each symptom will be defined using the Opioid-Related Symptom Distress Scale (OR-SDS) a participant rated scale of symptoms within the last 24 hours. Total CME score could range from 0 to 9. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.|Surgery Day, Day 1, 2, 3, 4, 5 PS, Discharge (day 3 up to day 7 PS), Day 7, 14, 28 PS|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed||Units on a scale||Standard Error|Least Squares Mean
739655|NCT00468845|Secondary|Incidence of Chronic Post-operative Pain|Chronic post-operative pain as a result of abdominal hysterectomy as reported by participants on PS questionaire of pain within last 24 hours in area affected by surgery.|3 and 6 Months PS|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed. Participants reported as no chronic pain in the 3 month visit were carried over to the missing data at 6 month visit.||Percentage of participants|||Number
739656|NCT00468845|Other Pre-specified|Neuropathic Pain Symptom Inventory (NPSI)|Pain characteristics in participants who reported pain (mBPI-sf, NPSI); NPSI a participant rated questionnaire to evaluate different symptoms of neuropathic pain, burning spontaneous pain, pressing spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dysesthesia at discharge. NPSI Total Score ranged from 0 to 0.5; NPSI subscales pain ranged from 0 (no pain) to 10 (worst pain). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.|Discharge (day 3 up to day 7 PS)|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed||Units on a scale||Standard Error|Least Squares Mean
739657|NCT00468845|Secondary|Time to Actual Discharge|Mean time from end of surgery to actual hospital discharge. Participant was expected to remain at the hospital for a minimum of 2 days following surgery.|Day 1 up to Day 7 PS|mITT||Hours||Standard Error|Mean
739658|NCT00468845|Secondary|Time to Meet Hospital Discharge Criteria|Mean time from end of surgery to meet protocol defined hospital discharge criteria: participant no longer received parental opioids, was able to dress and mobilize without assistance, and had normal intake of food and fluids.|Day 1 up to Day 7 PS|mITT||Hours||Standard Error|Mean
739659|NCT00468845|Secondary|Quality of Life Using EuroQol (EQ-5D) Health State Profile|"Participant rated questionnaire assessed current health for 6 domains: mobility/self-care/ usual activities/pain/discomfort/anxiety and depression. Scoring developed by EuroQol Group assigned a utility value for each domain in the profile. Scores ranged from 1 better health (no problems) to 3 worst health (eg, confined to bed). Score transformed and resulted in a total score range -0.594 to 1.000; higher score=better health state. Health profile scores estimated using Dolan computational algorithms 1997 and 2001. LS Means adjusted for treatment/pooled center/salpingo-oophorectomy strata."|Discharge (day 3 up to day 7 PS) and day 28 PS|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed||Units on a scale||Standard Error|Least Squares Mean
739660|NCT00468845|Secondary|Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication|Impact of current pain medication response scale: 0 (worst possible response) to 100 (best possible response). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.|Discharge (day 3 up to day 7 PS), Day 28 PS|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed||Units on a scale||Standard Error|Least Squares Mean
739661|NCT00468845|Secondary|Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication|Satisfaction with current pain medication ranged from 0 (worst possible response) to100 (best possible response). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.|Discharge (day 3 up to day 7 PS), Day 28 PS|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed||Units on a scale||Standard Error|Least Squares Mean
739662|NCT00468845|Secondary|Participant Satisfaction With Study Medication - Day 28 PS|Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.|Day 28 PS|mITT; N=number of evaluable participants analyzed||Percentage of participants|||Number
739663|NCT00468845|Other Pre-specified|Incision Length Correlated With Worst Pain|Incision length (cm) correlated with worst pain. Worst pain ranged from 0 (no pain) to 10 (worst pain imaginable). LS Means adjusted for treatment, pooled center, salpingo-oophorectomy strata.|Day 1|mITT||Centimeter (cm)||Standard Error|Least Squares Mean
739664|NCT00468845|Other Pre-specified|Percentage of Participants With Wound Healing Complications - End of Treatment|Pre-specified adverse events of wound healing complications based on Center for Disease Control and Prevention, 1999, guidelines for prevention of surgical site infection (SSI) wound healing complications included: superficial incisional SSI, deep incisional SSI, organ/space SSI or non-infections wound healing complication.|Day 1 up to Day 28 PS|Safety population||Percentage of participants|||Number
739665|NCT00468845|Secondary|Participant Satisfaction With Study Medication - Day 14 PS|Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.|Day 14 PS|mITT; N=number of evaluable participants analyzed||Percentage of participants|||Number
739666|NCT00468845|Secondary|Participant Satisfaction With Study Medication - Day 7 PS|Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.|Day 7 PS|mITT; N=number of evaluable participants analyzed||Percentage of participants|||Number
739667|NCT00468845|Secondary|Participant Satisfaction With Study Medication - Discharge|Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.|Discharge (day 3 up to day 7 PS)|mITT; N=number of evaluable participants analyzed||Percentage of participants|||Number
739668|NCT00468845|Secondary|Participant Satisfaction With Study Medication - Day 5 PS|Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.|Day 5 PS|mITT; N=number of evaluable participants analyzed||Percentage of participants|||Number
739669|NCT00468845|Secondary|Participant Satisfaction With Study Medication - Day 4 PS|Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.|Day 4 PS|mITT; N=number of evaluable participants analyzed||Percentage of participants|||Number
739670|NCT00468845|Secondary|Participant Satisfaction With Study Medication - Day 3 PS|Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.|Day 3 PS|mITT; N=number of evaluable participants analyzed||Percentage of participants|||Number
739671|NCT00468845|Secondary|Participant Satisfaction With Study Medication - Day 2 PS|Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.|Day 2 PS|mITT; N=number of evaluable participants analyzed;||Percentage of participants|||Number
739672|NCT00468845|Secondary|Participant Satisfaction With Study Medication - Day 1 PS|Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.|Day 1 PS|mITT; N=number of evaluable participants analyzed||Percentage of participants|||Number
739673|NCT00468845|Secondary|Participant Satisfaction With Study Medication - Surgery Day|Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.|Day 1|mITT; N=number of evaluable participants analyzed||Percentage of participants|||Number
739674|NCT00468845|Other Pre-specified|Percentage of Participants With Wound Healing Complications - Day 28 PS|Pre-specified adverse events of wound healing complications based on Center for Disease Control and Prevention, 1999, guidelines for prevention of surgical site infection (SSI) wound healing complications included: superficial incisional SSI, deep incisional SSI, organ/space SSI or non-infections wound healing complication.|Day 28 PS|Safety population||Percentage of participants|||Number
739675|NCT00468845|Other Pre-specified|Percentage of Participants With Wound Healing Complications - Day 14 PS|Pre-specified adverse events of wound healing complications based on Center for Disease Control and Prevention, 1999, guidelines for prevention of surgical site infection (SSI) wound healing complications included: superficial incisional SSI, deep incisional SSI, organ/space SSI or non-infections wound healing complication.|Day 14 PS|Safety population||Percentage of participants|||Number
739676|NCT00468845|Secondary|Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores|"m-BPI-sf: participant rated 11-point Likert rating scale ranging from 0 (no pain) to 10 (worst pain possible). Pain severity index is the mean of item scores 2, 3, and 4 (pain right now, worst pain, and average pain level).
LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata."|Baseline, Discharge (day 3 up to day 7 PS), Day 7, 14, 28 PS|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed||Units on a scale||Standard Error|Least Squares Mean
739677|NCT00468845|Other Pre-specified|Percentage of Participants With Wound Healing Complications - Day 7 PS|Pre-specified adverse events of wound healing complications based on Center for Disease Control and Prevention, 1999, guidelines for prevention of surgical site infection (SSI) wound healing complications included: superficial incisional SSI, deep incisional SSI, organ/space SSI or non-infections wound healing complication.|Day 7 PS|Safety population||Percentage of participants|||Number
739678|NCT00468845|Other Pre-specified|Percentage of Participants With Wound Healing Complications - Discharge|Pre-specified adverse events of wound healing complications based on Center for Disease Control and Prevention, 1999, guidelines for prevention of surgical site infection (SSI) wound healing complications included: superficial incisional SSI, deep incisional SSI, organ/space SSI or non-infections wound healing complication.|Discharge (day 3 up to day 7 PS)|Safety population all participants who were administered at least one dose of double blind medication, and for whom at least one post-baseline safety evaluation was obtained were included.||Percentage of participants|||Number
739679|NCT00468845|Secondary|Brief Pain Inventory-Short Form (m-BPI-sf): Pain Interference Index Scores|m-BPI-sf: participant-rated 11 point Likert rating scale ranging from 0 (does not interfere) to 10 (completely interferes) with functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.|Baseline, Discharge (day 3 up to day 7 PS), Day 7, 14, 28 PS|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed||Units on a scale||Standard Error|Least Squares Mean
739680|NCT00468845|Secondary|Sleep Interference|Sleep interference post surgery measured daily in participant diaries; NRS of how pain interfered with sleep during the last 24 hours, ranged from 0 (does not interfere) to 10 (completely interferes). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.|Daily post hospital discharge ( Day 2-7 PS), Week 2, 3, 4 PS|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed||Units on a scale||Standard Error|Least Squares Mean
739739|NCT00459108|Primary|Four Month Progression-free Survival (PFS)|Progression-free survival calculated using the method of Kaplan-Meier.|4 months|||participants progression-free after 4 mo|||Number
739681|NCT00468845|Secondary|Worst Daily Pain|Post-discharge worst pain as measured in daily participant diaries NRS an 11 point Likert scale that ranged from 0 (no pain) to 10 (pain as bad as you can imagine). LS Means from ANOVA model with terms of treatment, pooled center, salpingo-oophorectomy strata and baseline worst pain score.|Discharge (day 3 up to day 7 PS), Day 7, 14, 28 PS|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed||Units on a scale||Standard Deviation|Mean
739682|NCT00468845|Secondary|Average Daily Pain|Post-discharge average pain as measured in daily participant diaries NRS an 11 point Likert scale ranged from 0 (no pain) to 10 (worst pain). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.|Day 2, 3, 4, 5, 6, 7, PS; week 2, 3, 4 PS|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed||Units on a scale||Standard Error|Least Squares Mean
739683|NCT00468845|Secondary|Timed Up-and-Go (TUG)|Functional mobility test performed once a day at 24 hour intervals from surgery after the pain with movement assessment. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.|Day 1, 2, 3, 4, 5 PS and Discharge (day 3 up to day 7 PS)|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed||Seconds||Standard Error|Least Squares Mean
739684|NCT00468845|Secondary|Percent Change From Baseline in Peak Expiratory Flow|Change from baseline= PEF at x hours minus PEF at baseline; possible values ranged from 0-900 liters/minute (higher values indicated better lung function). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.|Baseline, every 8 hours (up to 232 hours) PS, and Discharge (Day 3-7 PS flexible)|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed; Results presented for only those timepoints PS where at least 4 participants in each treatment arm completed the questionnaire at baseline and respective time point.||L/min||Standard Error|Least Squares Mean
739685|NCT00468845|Secondary|Non-opioid Rescue Medication - Ibuprofen|The amounts of non-opioid rescue medications, ibuprofen, used by the participants during the study, including anti-emetic medications.|24, 48, 72 hours PS, Discharge (day 3 up to day 7 PS), Week 1, 2, 3, 4 PS|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed||Grams (g)||Standard Deviation|Mean
739686|NCT00468845|Secondary|Anxiety Before and After Surgery|Participant anxiety reported on Visual Anxiety Scale (VAS), 0 (not at all anxious) to 100 (extremely anxious). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata|Surgery day before first dose and 1 hour after first dose, Day 1, 2, 3, 4, 5 PS and Discharge (day 3 up to day 7 PS)|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed||Units on a scale||Standard Error|Least Squares Mean
739687|NCT00468845|Secondary|Non-opioid Rescue Medication - Paracetamol|The amounts of non-opioid rescue medications, paracetamol, used by the participants during the study, including anti-emetic medications.|24, 48, 72 hours PS, Discharge (day 3 up to day 7 PS), Week 1, 2, 3, 4 PS,|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed||Grams (g)||Standard Deviation|Mean
739688|NCT00468845|Secondary|Integrated Analgesic Score|The integrated analgesic score (a combination of opioid use and either worst pain, or pain at rest, or pain caused by sitting, or pain caused by forced expiration as defined by Silverman et al 1993) was the sum of percent differences from mean rank for pain and opioids and ranged from -200 to 200 where lower values represent improvement. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.|0-24, 24-48, 48-72 hours PS|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed||Units on a scale||Standard Error|Least Squares Mean
739689|NCT00468845|Secondary|Total Cumulative Dose of Opioids Following Surgery|Total cumulative dose was calculated as milligram (mg) of morphine equivalent and included opioids administered by any route. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.|24, 48 Hours PS, Discharge (day 3 up to day 7 PS)|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed||milligram (mg)||Standard Error|Least Squares Mean
739690|NCT00468845|Secondary|Area Under the Curve (AUC) of Pain at Rest During the First Two Days of Hospital Stay|Time-normalized AUC of pain reported by participants on 11 point Likert scale 0 (no pain) to 10 (worst pain). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.|48 +/- 4 hours PS|mITT; N=number of evaluable participants analyzed||Units on a scale||Standard Error|Least Squares Mean
739691|NCT00468845|Secondary|Current Pain at Rest|Pain reported by participants at rest (numeric rating scale (NRS) – Current Pain) on an 11 point Likert scale 0 (no pain) - 10 (worst pain). Pain at rest during the hospital stay was assessed just before each Pain with Movement assessment. Assessment performed 3 times each day of hospital stay, with 1 of daily assessments at 24 (+/- 2 ) hour intervals from end of surgery. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.|8, 16, 24, 32, 40, 48 hours PS|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed||Units on a scale||Standard Error|Least Squares Mean
739692|NCT00468845|Secondary|Area Under the Curve (AUC) Pain - Pain With Movement Caused by Peak Expiratory Flow (PEF) Test|Time-normalized AUC of pain reported by participants with movement caused by PEF test. Pain reported by participant on 11 point Likert scale 0 (no pain) to 10 (worst pain). PEF test performed 3 times, with 120sec rest periods in between. At beginning of each rest period, participant asked to rate pain caused by forced expiration. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.|48 +/- 4 hours PS|mITT; N=number of evaluable participants analyzed||Units on a scale||Standard Error|Least Squares Mean
739693|NCT00468845|Secondary|Area Under the Curve (AUC) Pain - Pain With Movement Caused by Sitting|Time-normalized AUC of pain with movement caused by sitting reported by participants. Participant sat upright from supine position, followed by a 120sec rest period, during which the participant asked to rate pain with movement. Assessment performed 3 times each day of hospital stay, with 1 daily assessment at 24 (+/- 2) hour interval from end of surgery. Current pain reported on 11 point Likert scale 0 (no pain) to 10 (worst pain imaginable). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.|48 +/- 4 hours PS|mITT; N=number of evaluable participants analyzed||Units on a scale||Standard Error|Least Squares Mean
739740|NCT00459108|Primary|Response Rate (Complete and Partial Response)|Patients with confirmed partial or complete response using the RECIST criteria.|4 months|||percentage of responding patients|||Number
739694|NCT00468845|Secondary|Current Pain - Pain With Movement Caused by Peak Expiratory (PEF) Test|Current pain with movement caused by peak expiratory flow (PEF) test as reported by participant on 11 point Likert scale 0 (no pain) to 10 (worst pain). Assessment performed 3 times each day of hospital stay, with 1 daily assessment at 24 (+/- 2) hour interval from end of surgery. PEF test performed 3 times, with 120sec rest periods in between. At beginning of each rest period, participant asked to rate pain caused by forced expiration. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.|Day 1, up to 7 days PS, 2 and 4 weeks PS|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed; Results presented for only those timepoints PS where at least 4 participants in each treatment arm completed the questionnaire at baseline and respective time point.||Units on a scale||Standard Error|Least Squares Mean
739695|NCT00468845|Secondary|Current Pain - Pain With Movement Caused by Sitting|Participant sat upright from supine position, followed by 120 second (sec) rest period, during which participant asked to rate pain with movement. Assessment performed 3 times each day of hospital stay, with 1 daily assessment at 24 (+/- 2) hour interval from end of surgery. Current pain reported on 11 point Likert scale 0 (no pain) to 10 (worst pain imaginable). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.|Day 1 (day of surgery), up to 7 days PS, Discharge, 2 and 4 weeks PS|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed; Results presented for only those timepoints PS where at least 4 participants in each treatment arm completed the questionnaire at baseline and respective time point.||Units on a scale||Standard Error|Least Squares Mean
739696|NCT00468845|Primary|Worst Pain Using the Modified Brief Pain Inventory - Short Form (m-BPI-sf)|"Modified Brief Pain Inventory - Short Form (m-BPI-sf): participant rated 11-point Likert rating scale ranged from 0 (no pain) to 10 (worst pain imaginable).
Least Square (LS) Means adjusted for treatment, pooled center and salpingo-oophorectomy strata."|Day 2 (24 hours post surgery [PS])|Modified intent-to-treat (mITT) population: participants who received at least 1 dose study drug, had at least 1 post baseline safety and efficacy evaluation, took all pre-surgery medication, had no complications during surgery with discontinuation, no PS infection with additional hospitalization/readmission, had primary efficacy measurement PS||Units on a scale||Standard Error|Least Squares Mean
739697|NCT00468858|Secondary|Vaccine Response to DEN Antibody at Post Dose 2, Month 7|Vaccine response for DEN-1, DEN2, DEN-3, DEN-4 antibody at post dose 2, month 7|at month 7, post dose 2|||% of subjects||95% Confidence Interval|Number
739698|NCT00468858|Secondary|Vaccine Response to DEN Antibody at Post Dose 1, Month 3|"Vaccine response for DEN-1, DEN-2, DEN-3 and DEN-4 antibody
S- = seronegative subjects (antibody titer <10 ED50 for DEN-1, 2, 3, and 4 prior to vaccination; S+ = Seropositive subjects (antibody titer >10 ED50 for DEN-1, 2, 3 and 4 prior to vaccination; Total = subjects either seropositive or seronegative at pre-vaccination
Vaccine response defined as: For initially seronegative subjects, antibody titer >10 ED50 at PI(M3) and for initially seropositive subjects: antibody titer at PI(m3) >4 fold the pre-vaccination antibody titer"|at month 3, post dose 1|||% of subjects||95% Confidence Interval|Number
739699|NCT00468858|Secondary|Percent of Subjects With Neut. Sero-response to Each DEN Serotype|Seropositivity rates for DEN neut. antibodies for unprimed and primed subjects|Pre-accination, at post dose 1, months 3 and 6 and post dose 2, month 7|||percent of subject with attribute||95% Confidence Interval|Number
739700|NCT00468858|Secondary|Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes|Monovalent, bivalent, trivalent and tetravalent response for DEN neut. antibodies for unprimed and primed subjects|Pre-vaccination, at post dose 1, months 3 and 6 and post dose 2, month 7|||% of subjects||95% Confidence Interval|Number
739701|NCT00468858|Secondary|GMTs for Antibody Titer Above the Assay Cut Off to Each DEN Serotype for Unprimed and Primed Subjects|Comparison of F17 and F19 formulations in terms of GMTs at month 7 (one month post dose 2) for each DEN type, -unprimed and primed subjects|at month 7 (one month post dose 2)|||titers||95% Confidence Interval|Mean
739702|NCT00468858|Secondary|Incidence of Suspected and Laboratory Confirmed Dengue|Incidence of suspected and confirmed dengue reported during the 31-day (Days 0-30) post-vaccination period and after the 31-day period|31-day (days 0-30) post-vaccination period and after 31-day period|||dengue fever cases|||Number
739703|NCT00468858|Primary|Safety: Occurrence of Serious Adverse Events (SAEs)|Summary of SAEs, 6 months + 30 day follow-up period after last vaccine dose|6 months + 30 day follow-up period after last vaccine dose|||Participants|||Count of Participants
739704|NCT00468858|Primary|Safety: Summary of Unsolicited Adverse Events Within the 31-day Post-vaccination Period|Summary of unsolicited Adverse Events within the 31-day post-vaccination period by age group (total vaccinated cohort)|Within the 31-day (days 0-30) follow-up period after each vaccine dose|||Participants|||Count of Participants
739705|NCT00468858|Primary|Safety: Incidence of All and Grade 3 Solicited Local Symptoms|Incidence of all and grade 3 (prevents normal, everyday activities) solicited local and general symptoms within the 21-day follow-up period (Total vaccinated cohort)|Within 21 days (days 0-20) f/up period after each vaccine dose|||number of occurances|||Number
739706|NCT00468910|Other Pre-specified|Platelet Cyclooxygenase (COX) Activity as Measured by a Peroxidase-based COX Enzyme Activity Assay|Evaluate the effect of aspirin on platelet COX activity as measured by a peroxidase-based Cox enzyme activity assay.|3 months from baseline colonoscopy to end of intervention.|Subjects at high risk for colorectal cancer (CRC) with a cancer-associated spectral marker signature in histologically normal colonic mucosa.||pg/ml||Standard Deviation|Mean
739707|NCT00468910|Secondary|Rectal Prostaglandin Levels as Measured by ELISA|Evaluate the effect of aspirin on rectal prostaglandin levels.|3 months from baseline colonoscopy to end of intervention.|Subjects at high risk for colorectal cancer (CRC) with a cancer-associated spectral marker signature in histologically normal colonic mucosa.||pg/ml||Standard Deviation|Mean
739708|NCT00468910|Secondary|Changes in Colonic Cell Proliferation as Measured by Immunohistochemical Detection of Ki67|Evaluate the effect of aspirin on colonic epithelial apoptosis and cell proliferation as assessed by immunohistochemical detection of Ki-67. These were performed on samples that had been previously analyzed for 4D-ELF.|3 months from baseline colonoscopy to end of intervention.|Subjects at high risk for colorectal cancer (CRC) with a cancer-associated spectral marker signature in histologically normal colonic mucosa.||Percentage of Total Cells||Standard Deviation|Mean
739741|NCT00459121|Secondary|Assess the Complete Pathologic Complete Response (CR) Rate With This Regimen.|Evaluation of the number of patients who have no evidence of tumor in the resected tumor.|30 days post surgery||||||
739709|NCT00468910|Secondary|Colonic Epithelial Apoptosis as Measured by Immunohistochemical Detection of Cleaved Caspase 3|Evaluate the effect of aspirin on colonic epithelial apoptosis and cell proliferation as assessed by immunohistochemical detection of cleaved caspase 3 .These were performed on samples that had been previously analyzed for 4D-ELF.|3 months from baseline colonoscopy to end of intervention.|Subjects at high risk for colorectal cancer (CRC) with a cancer-associated spectral marker signature in histologically normal colonic mucosa.||Percentage of Total Cells||Standard Deviation|Mean
739710|NCT00468910|Primary|Change of a Spectral Biomarker for Colonic Carcinogenesis (Called Fractal Dimension or FRAC) From Baseline to 3 Months.|"Spectral marker assessment was performed via LEBS analysis (low-coherence enhanced backscattering spectroscopy) on the uninvolved mucosal biopsies of subjects taken at baseline and after 3 months of treatment with either aspirin or placebo. FRAC characterizes the spatial autocorrelation function of mass density distribution in tissue.
SPEC and FRAC provide a measure of the fundamental characteristics of the tissue nanoscale architecture"|3 months from baseline colonoscopy to end of intervention.|Subjects at high risk for colorectal cancer (CRC) with a cancer-associated spectral marker signature in histologically normal colonic mucosa||unitless||Standard Deviation|Mean
739711|NCT00468910|Primary|Change of a Spectral Biomarker for Colonic Carcinogenesis (Called Spectral Slope or SPEC) From Baseline to 3 Months.|"Spectral marker assessment was performed via LEBS analysis (low-coherence enhanced backscattering spectroscopy) on the uninvolved mucosal biopsies of subjects taken at baseline and after 3 months of treatment with either aspirin or placebo. SPEC characterizes the size distribution of macromolecular complexes and other intracellular structures, with a decrease of the spectral slope implying a shift of the size distribution of intracellular structures toward smaller sizes.
Spectral markers SPEC and FRAC provide a measure of the fundamental characteristics of the tissue nanoscale architecture."|3 months from baseline colonoscopy to end of intervention.|Subjects at high risk for colorectal cancer (CRC) with a cancer-associated spectral marker signature in histologically normal colonic mucosa.||micron^-1||Standard Deviation|Mean
739712|NCT00469079|Secondary|Product Effect on Craving and Nicotine Withdrawal Symptoms at 1 Week.|Changes in craving and withdrawal symptoms were assessed at the time of discontinuation of usual brand cigarettes (i.e., baseline compared to week 1). Assessments were made using the Minnesota Nicotine Withdrawal Scale, which measures abstinence effects from usual brand cigarettes. Total Score: Range of scores is from 0 to 28. All items with the exclusion of craving are summed. Craving Score: Range of score is from 0 to 4. A higher score would indicate more severe withdrawal.|Baseline and 1 week|All subjects completing the intervention||units on a scale||Standard Error|Mean
739713|NCT00469079|Primary|Abstinence From Tobacco at End of Treatment, 1 Week and 11 Weeks Post-intervention.|This study was not powered to detect differences in smoking cessation rates between groups; however, smoking status was collected at each visit to obtain preliminary data. Point prevalence (no smoking during the previous 7 days) cigarette abstinence rates were calculated at the end of treatment and at each of the 2 follow-up visits (week 1 and 11 post-intervention). Continuous abstinence rates were calculated for the 4 week period between the week 1 and week 4 visits. Abstinence at all visits was assessed by self-report (i.e., no cigarettes smoked) and confirmed by an exhaled CO of less than 8 ppm. At the follow-up visits, abstinence was also confirmed by both exhaled CO concentrations and urinary cotinine concentration (<35 ng/mL).|12 weeks|Intent to treat model.||participants|||Number
739714|NCT00469079|Primary|Product Use at Week 4 of Intervention|Self-reported daily use of the assigned study product. Range of scores is from 0 to about 20. Higher scores do not represent either a better or a worse outcome. Higher number of product used per day may indicate higher abuse liability of the product but may lead to a greater suppression in usual brand cigarette smoking. Lower number of product use per day may indicate lower abuse liability but may lead to lower suppression of usual brand smoking.|4 weeks|All subjects who completed intervention.||uses per day||Standard Error|Least Squares Mean
739715|NCT00469079|Primary|Toxicant Exposure by Products|Levels of carcinogen biomarkers (NNAL) reported as difference between baseline and week 4 scores.|Baseline, 4 weeks|All subjects who continued in the protocol were analyzed. Non-parametric Kruskal-Wallis method of analysis was used.||ng/ml||95% Confidence Interval|Geometric Mean
739716|NCT00469092|Secondary|Number of Subjects Reporting Treatment Emergent Adverse Events|Number of subjects reporting treatment emergent adverse events during the trial (from week 0 to week 26). Adverse events were reported as treatment emergent if they occurred from the date of first insulin trial product administration up to and including the date of last insulin trial product administration.|Weeks 0-26|The safety analysis population consists of all subjects exposed to trial products.||participants|||Number
739717|NCT00469092|Secondary|Number of Hypoglycaemic Episodes|Total number of hypoglycaemic episodes experienced in each treatment arm. Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no plasma glucose or blood glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L or 56 mg/dL.|Weeks 0-26|||events|||Number
739718|NCT00469092|Secondary|Treatment Satisfaction as Measured by the Diabetes Medication Satisfaction Questionnaire (Diab MedSat)|Subjects assessed the burden, efficacy, symptoms and overall score in the treatment satisfaction questionnaire, Diab MedSat (Diabetes Medication Satisfaction questionnaire). The scores were transformed to a 0-100 scale with higher scores indicating greater satisfaction. The score of the subscales was computed as the mean of the items in each subscale.|After 26 weeks of treatment|Intention to Treat, Last Observation Carried Forward population. All randomised subjects exposed to trial drug, and who had at least a baseline HbA1c measurement and at least one post randomisation HbA1c measurement.||scores on a scale||Standard Error|Mean
739719|NCT00469092|Secondary|Number of Subjects Achieving the Treatment Target for Glycosylated Haemoglobin A1c (HbA1c)|The number of subjects achieving the treatment target for glycosylated haemoglobin A1c after 26 weeks treatment. The treatment targets were: HbA1c <= 6.5% of haemoglobin and HbA1c < 7% of haemoglobin.|After 26 weeks of treatment|Intention to Treat, Last Observation Carried Forward population. All randomised subjects exposed to trial drug, and who had at least a baseline HbA1c measurement and at least one post randomisation HbA1c measurement.||participants|||Number
740343|NCT00470470|Primary|Objective Response Rate|Response will be evaluated in this study using the new international criteria proposed by the RECIST Committee. A Simon two-stage minimax design will be employed.|Every 6 weeks for the first 3 courses and then every 12 weeks thereafter|||participants|||Number
739720|NCT00469092|Secondary|9-point Self-measured Plasma Glucose Profiles|Glycaemic control measured by 9-point self-measured plasma glucose (SMPG) profiles. The 9 time points for self-measurement during the day were: Before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, before bedtime, at 2-4 AM, and before breakfast the following day. Hypoglycaemia episodes were defined as major or minor. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L or 56 mg/dL.|After 26 weeks of treatment|Intention to Treat, Last Observation Carried Forward population. All randomised subjects exposed to trial drug, and who had at least a baseline HbA1c measurement and at least one post randomisation HbA1c measurement.||mmol/L||Standard Error|Mean
739721|NCT00469092|Primary|Glycosylated Haemoglobin A1c (HbA1c)|Glycosylated Haemoglobin A1c measured in blood samples after 26 weeks of treatment.|After 26 weeks of treatment|Intention to Treat (Last Observation Carried Forward) population. All randomised subjects exposed to trial drug, and who had at least a baseline HbA1c measurement and at least one post randomisation HbA1c measurement.||percentage of total haemoglobin||Standard Deviation|Least Squares Mean
739722|NCT00469209|Secondary|Time to Toxicity|The time to patient toxicity of drug combination bortezomib with arsenic trioxide, ascorbic acid and high-dose melphalan defined in days from baseline measure to occurence of adverse events grade 4 (life threatening or disabling) according to National Cancer Institute Common Toxicity Criteria (CTC), version 3.|Baseline to event occurence (assessed weekly first 30 days)||||||
739723|NCT00469209|Primary|Number of Patients Reaching Complete Response (CR)|Number of participants with CR at Day 180 who had maintained CR for at minimum of 4 weeks, and who had: No monoclonal protein in urine/serum when analyzed by immunofixation electrophoresis; bone marrow normal by morphological examination with <5% plasma cells, <1% aneuploid light chain restricted population by flow cytometry for DNA/cIg; and, while healing of bony lesion is not required, no new lytic lesion should appear. Further compression fracture of spine not considered progressive disease.|Baseline through Day 180, with assessments at Day 90 and Day 180|Analysis was per protocol.||participants|||Number
739724|NCT00469274|Primary|Evidence of Pertussis Infection in Each PEP Arm, Defined Using Clinical, Microbiologic, or Serologic Criteria.|Defined as a positive nasopharyngeal culture or PCR for B. pertussis at any time point, a two-fold rise in the anti-PT IgG titer between acute and convalescent sera, or a single acute or convalescent anti-PT IgG titer of ≥94 EU. Post hoc, a modified definition was devised because of concern that the serologic criteria used in the primary definition might actually represent acquisition of pertussis infection prior to the intervention. The modified definition of pertussis excluded an acute anti-PT IgG titer of ≥94 EU and an acute nasopharyngeal swab that was positive for B. pertussis by PCR.|In the 21 days following exposure identification|||participants|||Number
739725|NCT00469391|Primary|Percent Excess Weight Loss (%EWL) at Week 12|Excess Weight Loss was calculated using the Metropolitan Life Table (MET method)|3 months|||Percentage of Excess Weight Loss||Standard Deviation|Mean
739726|NCT00458536|Secondary|to Correlate Immunologic Response Following Vaccination.||5 years||||||
739727|NCT00458536|Secondary|To Determine if Cellular and Humoral Immunity is Induced by Serial Vaccination With DC/Tumor Fusion Cells and GM-CSF||5 years||||||
739728|NCT00458536|Primary|Number of Participants With Adverse Events Associated With Vaccination With Mature DC/Tumor Fusion and GM-CSF||5 years|Adverse events potentially related to vaccination were largely restricted to injection site reactions. 12 of the 19 patients experienced vaccine site reactions.||participants|||Number
739729|NCT00458705|Primary|Disease Response|The response of myeloma to BDDTD will be assessed by standard electrophoretic and immunofixation tests of blood and urine for a monoclonal protein (M protein), and bone marrow aspirate and biopsy. These tests will be performed at enrollment and at the conclusion of therapy.|2 years|||participants|||Number
739730|NCT00458822|Primary|Hematologic and Organ Response|patients will be assessed for hematologic response (the response of the clonal plasma cell disease). If the plasma cell disease persists, then they will receive 6 cycles of adjuvant therapy with bortezomib and dexamethasone; patients with peripheral neuropathy will receive dexamethasone alone because of the risk of neuropathy associated with bortezomib. Symptomatic organ involvement with amyloid as defined below. Patients must have symptomatic involvement of no more than 2 of the following 4 visceral organ-systems: kidneys, liver/GI, peripheral/autonomic nervous system, and heart.|2-3 months post transplant|||participants|||Number
739731|NCT00458952|Primary|MTD of Ultratrace Iobenguane I 131|Although no primary efficacy endpoint was defined for this study, the MTD of Ultratrace iobenguane I 131 in patients with malignant pheochromocytoma/paraganglioma (a safety rather than an efficacy parameter) is the primary objective.|6 weeks post therapy dose|24 patients with confirmed pheochromocytoma/paraganglioma were recruited for participation in this trial. Of the 24 consenting patients, 21 patients were administered Ultratrace iobenguane I 131. Three patients did not meet all the inclusion and exclusion criteria, and were not allowed into the study.||mCi/kg|||Number
739732|NCT00459043|Secondary|Overall Survival||3 years|||weeks||95% Confidence Interval|Median
739733|NCT00459043|Secondary|Progression Free Survival|Progression is defined using the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) as a 20% increase in the sumof the longest diameter of target lesions, or a measurable increase in a non-target lesion or the appearance of new lesions|3 years|||weeks||95% Confidence Interval|Median
739734|NCT00459043|Primary|Partial Response Rate in Both Groups of Patients.|Objective tumor response was evaluated radiogically using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. For target lesions: Complete Response (CR) disappearance of all target lesions; Partial Response (PR) >= 30% decrease in the sum of the longest diamter of target lesions; Overall Response (OR) = CR+PR|3 years|29 patients were analyzable||percentage of participants||95% Confidence Interval|Number
739735|NCT00459056|Primary|Change in Reactive Hyperemic Index by Period (Carvedilol CR + Lisinopril vs. Lisinopril + HCTZ)|Reactive hyperemic index is a measure of endothelial function. This is measured by the ratio of post-occlusion blood volume flow versus the baseline blood volume flow. The outcome reported is the change in this ratio after the first intervention phase compared to after the second intervention phase.|Change from three months to seven months|All completers were included in the analysis||Ratio||Standard Deviation|Mean
739736|NCT00459108|Secondary|Safety and Tolerability||Up to 4 years||||||
739737|NCT00459108|Secondary|Overall Survival||Up to 4 years||||||
739738|NCT00459108|Secondary|Median PFS||Up to 4 years||||||
739742|NCT00459121|Secondary|Assess the Clinical Response Rate of the Proposed Pre-operative Regimen|Patients will undergo tumor evaluation when all of the three cycles have been completed unless the treating physician has concerns regarding tumor progression. If the patient has undergone tumor evaluation prior to the last cycle the patient will require repeat tumor assessment within 4 weeks of completion of the last cycle of therapy|End of three cycles of treatment||||||
739743|NCT00459121|Secondary|Assess Toxicity of This Regimen and the Percentage of Patients Completing All Planned Cycles of Therapy|Serum chemistry includes Albumin, alkaline phosphatase, total bilirubin, bicarbonate, BUN, calcium, chloride, creatinine, glucose, potassium, total protein, SGOT [AST], SGPT [ALT], sodium, laboratory tests should be done on a weekly basis for the first cycle. After the first cycle laboratory tests should be done within 72 hours of each dose of carboplatin/paclitaxel.|Weekly for the first cycle; Thereafter within 72 hours of each dose of carboplatin/paclitaxel||||||
739744|NCT00459121|Secondary|Post-Operative Mortality Rate||at 30 days||||||
739745|NCT00459121|Primary|Complete Resection (R0) Rate||Following three cycles of pre-operative zactima and carboplatin/paclitaxel|No analysis will be completed.|||||
739746|NCT00459134|Secondary|Quality of Life|Patients filled out the FACT-G quality of life questionnaire at baseline and at 4, 8, and 12 weeks following randomization. The FACT-G questionnaire is comprised of 7 questions related to physical well-being, 7 questions related to social well-being, 6 questions related to emotional well-being, and 7 questions related to functional well-being. Subscale scores range from 0 to 24 (Emotional) or 0 to 28 (Functional, Social, and Physical). A total FACT-G score is computed as the sum of the individual subscales; the overall score ranges from 0 to 108. Higher scores indicate better quality of life. The primary comparison was at 12 weeks.|12 weeks|Participants who filled out the FACT-G at any time||units on a scale||Standard Error|Least Squares Mean
739747|NCT00459134|Primary|Sexual Function|Patients filled out the Female Sexual Function Index (FSFI) at baseline and at 4, 8, and 12 weeks following randomization. The FSFI is comprised of 2 questions related to desire, 4 questions related to arousal, 4 questions related to lubrication, 3 questions related to orgasm, 3 questions related to satisfaction, and 3 questions related to pain. Subscale scores range from 1.2 to 6 (desire) or 0 to 6 (arousal, lubrication, orgasm, and pain) or 0.8 to 6 (satisfaction). A total FSFI score is computed as the sum of the individual subscales; the overall score ranges from 2 to 36. Higher scores indicate better sexual function. The primary outcome comparison is at 12 weeks.|12 weeks|Participants who filled out the FSFI at any time||units on a scale||Standard Error|Least Squares Mean
739748|NCT00459186|Secondary|Response Based on PET Scan|Patients were scanned using Positron Emission Tomography (PET) before and after receiving single agent RAD001. Patients were classified as having partial metabolic response, stable metabolic disease, or progressive metabolic disease based on changes in PET imaging from baseline to post-treatment. A positive FDG-PET for the purposes of this study consisted of a visualized area of abnormal increased FDG uptake that matched the anatomic location of an abnormality seen on bone scan or CT. Metabolic response was assessed for percent change in SUVmax according to the criteria of the European Organization for Research and Treatment of Cancer (EORTC) : partial metabolic response (PMR) ≤ -25%; stable metabolic disease (SMD) -25% + 25%; progressive metabolic disease (PMD) > 25%.|10 to 14 days after study entry|All patients receiving at least one dose of RAD001||percentage of participants||90% Confidence Interval|Number
739749|NCT00459186|Primary|Number of Patients Free of Dose Limiting Toxicity|"A dose limiting toxicity was defined as an adverse event or laboratory abnormality that occurs to patients on the Phase I portion of the trial, during the first 21 days following the first dose of RAD001/docetaxel during cycle 1, judged to be related to RAD001/docetaxel and meeting any of the following criteria:
Hematologic Toxicity:
CTCAE grade 4 neutropenia > 7 days or any Grade 3 or 4 neutropenia with fever Or CTCAE grade 3 or 4 thrombocytopenia > 7 days
Non-hematologic toxicity:
The occurrence of non-hematologic CTCAE grade 3 or 4 adverse events will be considered dose limiting, except for the following:
CTCAE grade 3 nausea or grade 3 or 4 vomiting CTCAE grade 3 or 4 vomiting will only be considered dose limiting if it occurs despite the use of standard anti-emetics.
CTCAE grade 3 or 4 fever identified with a source (i.e. infection, tumor)
CTCAE grade 3 or 4 alkaline phosphatase."|21 days|Patients who received combination treatment with RAD001 + Docetaxel||participants|||Number
739750|NCT00459290|Secondary|Progression-free Survival by Age (y)|"Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions.
CT scan or MRI is used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response."|Every other cycle, for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels.|Eligible and treated participants||months||95% Confidence Interval|Median
739751|NCT00459290|Secondary|Progression-free Survival by Performance Status||Every other cycle, for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels.|Eligible and treated participants||months||95% Confidence Interval|Median
739752|NCT00459290|Secondary|Progression-free Survival by Platinum Sensitivity|Platinum Senstive defined as treatment free interval >6 months on most recent platinum|Every other cycle, for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels.|Eligible and treated participants with treatment free interval available||months||95% Confidence Interval|Median
739753|NCT00459290|Secondary|Overall Survival||Five years|Eligible and treated participants||months||95% Confidence Interval|Median
739834|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 21, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: What Characteristics of the Device You Appreciate - Q21: How Much Do You Like the Feel of the Device? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.|Day 84|mITT. N=participants with evaluable data.||percentage of participants|||Number
739754|NCT00459290|Secondary|Progression-free Survival|"Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions.
CT scan or MRI is used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response."|Every other cycle, for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels.|Eligible and treated participants||months||95% Confidence Interval|Median
739755|NCT00459290|Primary|Frequency and Severity of Toxicity as Assessed by NCI CTCAE v3.0||Every cycle, during treatment.||||||
739756|NCT00459290|Primary|Proportion of Patients With Objective Tumor Response|"Complete and Partial Tumor Response by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Per RECIST v1.0 for target lesions and assessed by MRIor CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD.
CT scan or MRI is used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response."|Every other cycle, for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels.|Eligible and treated participants||percentage of participants||95% Confidence Interval|Number
739757|NCT00459290|Primary|Progression-free Survival at 6 Months|"Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions.
CT scan or MRI is used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response."|Every other cycle, for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels.|Eligible and treated participants||percentage of participants||95% Confidence Interval|Number
739758|NCT00459303|Primary|Best Corrected Contrast Sensitivity in Photopic Condition|"Contrast sensitivity testing was measured with spectacle correction for the target distance of three meters using a wall-mounted FACT sine-wave grating chart with nine levels of contrast (Stereo Optical Inc.)and five spatial frequency targets (1.5, 3, 6, 12, 18 cycles per degree (cpd)) at 250 lux. The last correct grating seen for each spatial frequency is recorded and translated by the EYEVIEW™ Functional Analysis Software into a log contrast sensitivity unit. The outcomes were recorded as average of the three post-operative measurements.
( physiological range of contrast sensitivity: 1.5 cpd : 25~82.5 ; 3 cpd: 30~150 ; 6 cpd: 65 ~ 200 ; 12 cpd: 20 ~130 ; 18 cpd: 6.5 ~ 65 )"|average data of post-operative 3rd week, 6th week, 12th week measurements|||units on a scale||Standard Deviation|Mean
739759|NCT00459303|Secondary|Total Ocular High-order Aberrations|A Hartmann-Shack aberrometer (Zywave, Bausch & Lomb Inc., Rochester, New York ) was used for measurement of HOAs of the whole eye. The measurements were done under maximal mydriasis with Mydrin-P (phenylephrine hydrochloride 0.5% and tropicamide 0.5%, Santen). The wavefront errors were described using the RMS of Zernike polynomials for total HOA at pupil diameters of 5 mm and 6 mm, primary spherical (Z 4,0) and 3rd-to 5th-order aberration at the pupil diameter of 6 mm.|average data of post-op 3rd, 6th, 12th week measurements|||μm||Standard Deviation|Mean
739760|NCT00459303|Secondary|Corneal High-order Aberrations|Corneal topography was performed with a TMS-4 corneal tomographer (Tomey, Japan). We used the 31-rings placido-based system that covers 10.9 mm of corneal diameter which is sufficient for the study of aberrations up to the fifth order for 6 mm diameter. Corneal HOAs were described with Zernike polynomials of 3rd- to 5th-order root-mean-square (RMS) of central 6mm diameter using VOLPro 6.89 software (Fa. Sarver and Associates, Carbondale. Ill, USA).|pre-op & averate data of post-op 3rd, 6th, 12th week measurements|||μm||Standard Deviation|Mean
739761|NCT00459303|Primary|Best Corrected logMAR Contrast Acuity at Photopic/Mesopic Condition|Contrast acuity testing was measured with spectacle correction for the target distance of three meters using a logMAR letter chart (Precision Vision®) represented on a wall-mounted illuminator cabinet. Two types of contrast charts were used, high contrast (Cat.No.2103 SLOAN translucent chart) and low contrast (Cat.No.2132 10% SLOAN translucent chart), and these were tested under both photopic (250 Lux) and mesopic (0.5 Lux) conditions. The contrast acuity tested ranges from 20/160 to 20/20(from worse to best), which equals LogMAR(Logarithm of the Minimum Angle of Resolution)0.9 to -0.3. All of the visual acuity and functional vision testing examinations mentioned above were performed by a single ophthalmologist. The outcomes were recorded as average of three post-operative measurments.|average data of post-op 3rd, 6th, 12th week measurements|"we obtained data and calculated the probable sample size needed from the following reference papers:
Ophthalmologe 2005 Jan;102(1):51-7.
Acta Ophthalmol Scand 2004;82(6):718-22."||log MAR||Standard Deviation|Mean
739762|NCT00459316|Primary|Number of Participants With Immunogenicity at Step 3 Weeks 4 and 24|Immunogenicity was assessed by the number of participants with protective levels of antibody (titers greater than or equal to 1:128)|At Step 3 Weeks 4 and 24 post-booster vaccine|"Participants with data for Step 3 weeks 4 and 24. The numbers for Group 1 (1-dose), Group 1 (2-dose), and Group 3 respectively are:
Week 4: 73, 71, 37 Week 24: 73, 70, 33"||participants|||Number
739835|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 20, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: What Characteristics of the Device You Appreciate - Q20: How Much Do You Like the Look of the Device? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.|Day 84|mITT. N=participants with evaluable data.||percentage of participants|||Number
739763|NCT00459316|Secondary|Safety, as Assessed by Number of Participants With Reactions and Grade 3 or Higher Adverse Events Within 42 Days Following Step 3 Dose of the Vaccine.|Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009, which is available on the RSC web site (http://rsc.tech-res.com/safetyandpharmacovigilance/). Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening, Grade 5 = death.|From administration of vaccination at Step 3 entry through 6 weeks post-vaccination|All participants who were vaccinated at Step 3 entry||participants|||Number
739764|NCT00459316|Secondary|Immunologic Memory or Primary Response for Serogroup C by Treatment Arm|"Immunologic Memory defined as:
Secondary (anamnestic) response defined as a four-fold rise in Ab titers between day 0 (booster dose) and day 7; or
Seroprotection on day 0 or change from titer <1:128 to titer ≥1:128 (seroprotection) between day 0 and day 7.
Primary Response defined as:
A four-fold rise in Ab concentration between day 0 and day 28, but not between day 0 and day 7; or
A change from titer <1:128 on day 0 to titer ≥1:128on day 28, but not between day 0 and day 7."|At Week 4 post-booster vaccination|Group 1 participants who entered Step 3||participants|||Number
739765|NCT00459316|Secondary|Immunologic Memory for Serogroup C by Treatment Arm (1 vs. 2 Doses)|"Evidence of immunologic memory according to each of the following definitions:
Secondary (anamnestic) response defined as a four-fold rise in Ab titers between day 0 (booster dose) and day 7; or
Seroprotection on day 0 or change from titer <1:128 to titer ≥1:128 (seroprotection) between day 0 and day 7."|At Week 1 post-booster vaccination|Participants in Group 1 who entered Step 3||participants|||Number
739766|NCT00459316|Secondary|Number of Participants With Protective Antibody Titers for Serogroup C at Step 3 Entry|Number of participants with protective antibody titers (rSBA>=1:128) for serogroup C by treatment arm (1 vs. 2 doses) of Group 1 (entry CD4% >= 15) at Step 3 entry|At 3.5 years|Group 1 and 3 participants at entry to Step 3||participants|||Number
739767|NCT00459316|Secondary|Immunogenic Response to Serogroup C in Group 2|Immunogenic response as assessed by number of participants with protective antibody titers (>= 1:128) to serogroup C in Group 2 (entry CD4%<15)|At Weeks 4, 28, and 72|Group 2 participants with response data for weeks 4, 28 and 72||participants|||Number
739768|NCT00459316|Primary|Number of Participants With Primary Response (in Step 3)|Primary response was defined for each serogroup as a four-fold rise in Ab concentration between day 0 and day 28, but not between day 0 and day 7; OR a change from seronegative on day 0 to seropositive on day 28, but not between day 0 and day 7. Note: a primary response can only occur in the absence of any memory response.|Step 3 entry and Week 4 post-booster vaccine|Because response is a combination of memory and primary response, only participants with data for weeks 0, 1 and 4 are included.||participants|||Number
739769|NCT00459316|Primary|Number of Participants With Seropositive Memory Response (in Step 3)|Seropositive memory response was defined for each serogroup by having protective antibody levels (titer >= 1:128) on Day 0 or change from seronegative to seropositive between booster dose (Day 0) and Day 7.|Step 3 entry and Week 1 post-booster vaccine|Because response is a combination of memory and primary response, only participants with data for weeks 0, 1 and 4 are included.||participants|||Number
739770|NCT00459316|Primary|Number of Participants With 4-fold Memory Response in Step 3|Defined for each serogroup as a four-fold rise in antibody titers between booster dose (week 0) and week 1.|Step 3 entry and Week 1 post-booster vaccine|Because response is a combination of memory and primary response, only participants with data for weeks 0, 1 and 4 are included.||participants|||Number
739771|NCT00459316|Primary|Number of Participants With Immunogenicity at Step 3 Entry|Immunogenicity was assessed for each serogroup by the number of participants with protective antibody levels (titers greater than or equal to 1:128)|At 3.5 years (Step 3 entry)|All participants who had antibody data for Step 3 Week 0||participants|||Number
739772|NCT00459316|Primary|Number of Participants With Reactions and Grade 3 or Higher Adverse Events Within 42 Days Following Dose 2 of the Vaccine.|Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009, which is available on the RSC web site (http://rsc.tech-res.com/safetyandpharmacovigilance/). Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening, Grade 5 = death.|From administration of Dose 2 at week 24 to 6 weeks post-vaccination|All participants who entered Step 2||participants|||Number
739773|NCT00459316|Primary|Number of Participants With Grade 3 or Higher Adverse Events Within 42 Days Following Dose 1 of the Vaccine.|Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009, which is available on the RSC web site (http://rsc.tech-res.com/safetyandpharmacovigilance/). Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening, Grade 5 = death.|From administration of Dose 1 at week 0 to 42 days post-vaccination|All participants who received Dose 1.||participants|||Number
739774|NCT00459316|Primary|Long-term Immunogenicity, as Assessed by Number of Participants With Protective Levels of Antibody at Week 72|Protective levels of antibody are titers ≥1:128.|Week 72|"Participants with antibody data at Week 72. The number of Participants analyzed for Group 1 (15<CD4%<25), Group 1 (CD4%≥25), Group 2, Group 3 respectively are:
serogroup A are 82, 108, 18, 44 serogroup C are 78, 110, 16, 44 serogroup W-135 are 80, 110, 17, 44 serogroup Y are 82, 110, 18, 44"||participants|||Number
739775|NCT00459316|Primary|Number of Participants With Short-term Immunogenicity, Defined as Number of Seroconverters at Week 4 (Those With at Least a 4-fold Rise in Meningococcal Serum Bactericidal Titers From Baseline)|Serum bactericidal antibody titers were measured at study entry and Week 4 for each of the four serogroups in the MCV-4 vaccine. Response (seroconversion) was defined as a 4-fold or greater increase from entry at Week 4.|At Study entry, Week 4|"This outcome only includes participants who had antibody data from both entry and Week 4.The number of participants analyzed for Group 1 (15<CD4%<25), Group 1 (CD4%≥25), Group 2, Group 3 respectively are:
serogroup A are 93, 129, 20, 49 serogroup C are 90, 130, 18, 49 serogroup W-135 are 91, 131, 19, 49 serogroup Y are 93, 131, 20, 49"||participants|||Number
739836|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 19, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How You Feel When Using the Device - Q19: Overall, Are You Emotionally Distressed or Anxious about Your Injections? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.|Day 84|mITT. N=participants with evaluable data.||percentage of participants|||Number
739776|NCT00459316|Primary|Number of Immunogenic Responders, With Response Defined as a 4-fold or Greater Increase in Serum Bactericidal Antibody Titers From Study Entry to Week 28 After 2 Doses of MCV-4.|Serum bactericidal antibody titers were measured at study entry and Week 28 for each of the four serogroups in the MCV-4 vaccine. Response was defined as a 4-fold or greater increase from entry at Week 28.|Study entry and Week 28|"This outcome only includes participants who received 2 doses and had antibody data from both entry and Week 28.The number of participants analyzed for Group 1 (15<CD4%<25), Group 1 (CD4%≥25), Group 2, Group 3 are respectively:
serogroup A: 49, 63, 20, 49 serogroup C: 47, 65, 18, 49 serogroup W-135: 47, 66, 19, 49 serogroup Y: 49, 66, 19, 49"||participants|||Number
739777|NCT00459342|Secondary|Time to Progression|Time in months from baseline assessment to disease progression or death for any reason, up to 5 years.|Up to 5 years||||||
739778|NCT00459342|Secondary|Overall Survival|Number of participants still living, measured from start of treatment to death from any cause, assessed up to 5 years using Kaplan-Meier.|Time from start of treatment to death from any cause, assessed up to 5 years||||||
739779|NCT00459342|Primary|Progression-free Survival (PFS)|PFS is defined as the duration of time from start of treatment to time of progression or death.|Time from start of treatment to time of progression or death, assessed at 2 months|Four participants were not evaluable for response.||months||95% Confidence Interval|Median
739780|NCT00459342|Primary|Number of Participants With Objective Response (Complete Response (CR) or Partial Response (PR))|Objective response defined as participants with Complete Response (CR) or Partial Response (PR) evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. RECIST definitions are Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. Response measured by tumor size on computed tomography scans and by metabolic activity on positron emission tomography scans.|12 weeks|Of the 34 eligible study participants enrolled, four participants were not evaluable for response.||participants|||Number
739781|NCT00459355|Primary|Caregiver Self-efficacy|Caregiver self-efficacy was measured by the Revised Checklist for Caregiving Self-Efficacy; the scale consists of 17 items which are rated from 0 - 100% confidence. The total score is summed from these percentages and ranges from 0 - 1700 where higher scores indicate a higher level of confidence.|3 months after baseline|||units on a scale||Standard Deviation|Mean
739782|NCT00459355|Secondary|Care Recipient Risky Behaviors and Accidents|The Risky Behavior Checklist listed common risky behaviors and accidents exhibited by care recipients with dementia based on previous research. Potential scores ranged from 0 - undetermined. The maximum score is undetermined because the measure represents the caregiver count of the number of times an incident occurred. In this study, sum scores ranged from 0 - 180.|3 months after baseline|||number of risky behaviors and accidents||Standard Deviation|Mean
739783|NCT00459355|Primary|Caregiver Strain|Caregiver Strain was measured by the MBRC Caregiver Strain Index; scores ranged from 0 - 15 with higher scores indicating more strain.|3 months after baseline|||units on a scale||Standard Deviation|Mean
739784|NCT00459368|Secondary|Patient Medical Care Costs||1 year||||||
739785|NCT00459368|Secondary|Patient-physician Communication (Patient Reported Measure)||survey following intervention period||||||
739786|NCT00459368|Secondary|Readiness to Improve ICS Adherence (Transtheoretical Model)||survey following intervention period||||||
739787|NCT00459368|Secondary|Patient Self-efficacy to ICS Treatment||survey following intervention period||||||
739788|NCT00459368|Secondary|Oral Steroid Use||1 year||||||
739789|NCT00459368|Secondary|Asthma-related Hospitalizations||1 year||||||
739790|NCT00459368|Secondary|Asthma-related Emergency Room Visits||1 year||||||
739791|NCT00459368|Primary|Patient Adherence to Inhaled Corticosteroids (ICS)|Adherence to ICS medication was measured during the last 3 months of the intervention (i.e., for the time period of 9-12 months post-randomization). Adherence was measured using pharmacy claims data, and represents the percent of prescribed medication taken. The normal range for this value is 0-100%.|1 year|||Percent of ICS medication taken||Standard Deviation|Mean
739792|NCT00459381|Secondary|Time to Progression or Progression Free Survival|"PFS for patients who died on treatment or within 30 days of the end of treatment w/out progression date, was date of death. All other pts without documented progression were censored at the date of last follow-up prior to start new treatment.
All 35 patients were included in an intent to treat analysis for PFS and OS. 3 pts censored for PFS, all less than 2 wks after study registration."|1 year|||weeks||95% Confidence Interval|Median
739793|NCT00459381|Secondary|Overall Survival|calculated from study registration until date of death or patient censored at the last date known alive|From date of registration to date of death due to any cause, assessed up to 2 years|All 35 patients were included in an intent to treat analysis for PFS and OS.||weeks||95% Confidence Interval|Median
739794|NCT00459381|Secondary|Best Radiographic Response|"Using the Macdonald criteria, the best MRI image response while the patient was on active treatment.
1: complete response; 2: partial response; 3:stable disease; 4:progression
Complete response imaging features: disappearance of all enhancing disease (measurable and non-measurable) sustained for at least 4 weeks; no new lesions clinical features; no corticosteroids; clinically stable or improved
Partial response imaging features: 50% or more decrease of all measurable enhancing lesions sustained for at least 4 weeks: no new lesions clinical features: stable or reduced corticosteroids; clinically stable or improved
Stable disease imaging features: does not qualify for complete response, partial response or progression clinical features: clinically stable
Progression imaging features: 25% of more increase in enhancing lesions; any new lesions clinical features: clinical deterioration"|3 years|||percentage of participants|||Number
739837|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 18, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How You Feel When Using the Device - Q18: Do You Dislike Injecting Yourself with this Device? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.|Day 84|mITT. N=participants with evaluable data.||percentage of participants|||Number
739795|NCT00459381|Secondary|Overall Radiographic Response (ORR) Rate|"The Macdonald criteria, roughly similarly to other systems, divides response into 4 types of response based on imaging (MRI) and clinical features
1: complete response; 2: partial response; 3:stable disease; 4:progression
Complete response imaging features: disappearance of all enhancing disease (measurable and non-measurable) sustained for at least 4 weeks; no new lesions clinical features; no corticosteroids; clinically stable or improved
Partial response imaging features: 50% or more decrease of all measurable enhancing lesions sustained for at least 4 weeks: no new lesions clinical features: stable or reduced corticosteroids; clinically stable or improved
Stable disease imaging features: does not qualify for complete response, partial response or progression clinical features: clinically stable
Progression imaging features: 25% of more increase in enhancing lesions; any new lesions clinical features: clinical deterioration"|2 years|34 pts had follow-up scans and wee evaluable for objective radiographic response (ORR)||percent||95% Confidence Interval|Number
739796|NCT00459381|Secondary|Most Common Toxicities Experienced After at Least One Dose of Pazopanib|NCI Common Toxicity Criteria (CTCAE) version 3.0. All patients that received at least one dose of pazopanib were evaluable. All events recorded that were related to drug were calculated per patient.|Up to 2 years|||percentage of participants|||Number
739797|NCT00459381|Primary|Number of Participants Discontinuing Treatment Due to Toxicity|Use NCI Common toxicity Criteria Adverse Event Version 3.0 to grade toxicities. Any patient who received at least one dose of pazopanib was evaluable for toxicity. Calculated the number of participants who had an event that was related to pazopanib that caused the patient to stop treatment due to this event.|2 years|||Participants|||Count of Participants
739798|NCT00459381|Primary|6 Months Progression-free Survival|Calculated from study registration till 6month time point. Progression defined by Macdonald criteria Progression imaging features: 25% of more increase in enhancing lesions; any new lesions clinical features: clinical deterioration|6 months|||percent||95% Confidence Interval|Number
739799|NCT00459537|Primary|Percentage of Participants With Complete Cure at the End of Study After Treating Participants for 48 Weeks.|Complete cure is defined as negative potassium hydroxide (KOH) microscopy and negative culture for dermatophytes and no residual involvement of the target toenail.|Week 52|The Per-protocol population (PP) consisted of ITT patients who completed the study without protocol deviations that led to exclusion according to criteria defined before database lock The per-protocol population was used to provide confirmation of efficacy findings from the ITT population. Last Observation Carried Forward (LOCF).||Percentage of participants|||Number
739800|NCT00459537|Secondary|Safety and Tolerability Assessed by the Number of Participants With Adverse Events|Safety and tolerability data as assessed by the number of participants with Adverse Events (AE), Serious Adverse Events, Drug discontinuation due to an AE or SAE and death. Additional details can be found in the Adverse Event Section.|Week 52|The Safety population consisted of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment.||Participants|||Number
739801|NCT00459537|Secondary|Percentage of Participants With Mycological Cure at End of Study After Treating Patients for 48 Weeks|Mycological cure is defined as negative KOH microscopy and negative culture for dermatophytes|Week 52|Intent-to-treat population, Last Observation Carried Forward (LOCF)||Percentage of participants|||Number
739802|NCT00459537|Secondary|Percentage of Participants With Clinical Effectiveness at the End of Study After Treating Patients for 48 Weeks.|Clinical effectiveness is defined as negative KOH microscopy and negative culture for dermatophytes and <= 10% residual involvement of the target toenail.|Week 52|Intent-to-treat population, Last Observation Carried Forward (LOCF)||Percentage of participants|||Number
739803|NCT00459537|Primary|Percentage of Participants With Complete Cure at the End of Study After Treating Participants for 48 Weeks|Complete cure is defined as negative potassium hydroxide (KOH) microscopy and negative culture for dermatophytes and no residual involvement of the target toenail.|Week 52|The Intent-to-treat population (ITT) population consisted of all patients who were randomized and dispensed study drug. Last Observation Carried Forward (LOCF)||Percentage of participants|||Number
739804|NCT00459667|Secondary|Percentage of Patients With Neutralizing Antibody Titer to IFNB-1b of Different Cut-off Values|Serum samples of about 8 mL for analysis of neutralizing antibodies (NAbs) to interferon (IFN) beta-1b were drawn at Baseline, Week 26 and the EOS visit.|309 days|For the NAb analyses data were provided for 572 patients at Baseline, 238 at Week 26 and 1261 at EOS. The patients missing to the total number of 1411 patients had no data at the respective visits (table shows number of patients with positive titer in the extension treatment cohorts; the analyses provide frequencies of positive titers).||Percentage of participants|||Number
739805|NCT00459667|Primary|Hematological Abnormalities|"The variable Hematological abnormalities will consist of a combination of MedDRA terms (Preferred Terms only) indicative for this condition."|309 days|The analysis set used for safety analysis (SAF) comprised 1411 patients. AEs were defined as events with an onset date after the first application of study drug. The incidence rate of hematological abnormalities were provided.||Percentage of participants|||Number
739806|NCT00459667|Primary|Liver Enzyme Elevations|"The variable Liver enzyme elevations will consist of a combination of MedDRA terms (Preferred Terms only) indicative for this condition."|309 days|The analysis set used for safety analysis (SAF) comprised 1411 patients. AEs were defined as events with an onset date after the first application of study drug. The incidence rate of liver enzyme elevations were provided.||Percentage of participants|||Number
739807|NCT00459667|Primary|Injection-site Reactions|"The variable Injection-site reactions will consist of a combination of MedDRA terms (Preferred Terms only) indicative for this condition."|309 days|The analysis set used for safety analysis (SAF) comprised 1411 patients. AEs were defined as events with an onset date after the first application of study drug. The incidence rate of Injection-site reactions with 95% confidence intervals were provided.||Percentage of participants|||Number
739808|NCT00459667|Primary|Flu-like-syndrome|"The variable Flu-like-syndrome will consist of a combination of MedDRA terms (Preferred Terms and Lower Level Terms) indicative for this condition."|309 days|The analysis set used for safety analysis (SAF) comprised 1411 patients. AEs were defined as events with an onset date after the first application of study drug. The incidence rate of Flu-Like-Syndrome with 95% confidence intervals were provided.||Percentage of participants|||Number
740605|NCT00460525|Secondary|Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by ELISA at Day 364|Titers of Anti-FMP2.1 antibody were determined by ELISA from sera collected at Day 364.|Day 364 after initial vaccination|Analyses are ITT. No imputation techniques were used.||Titer||95% Confidence Interval|Geometric Mean
739809|NCT00459706|Secondary|Participant Satisfaction at Endpoint Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. Mean participant satisfaction was determined for each cluster of participants. Satisfaction was scored on a 10-point scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction.|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 clusters who reported themselves as being very satisfied, satisfied, or not satisfied. n=number of participants who reported themselves as being very satisfied, satisfied, or not satisfied for the specified treatment arm and cluster.||units on a scale||Standard Deviation|Mean
739810|NCT00459706|Secondary|Percentage of Participants Receiving Only 3 DMARDs Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, all participants receiving DMARDs (only 1, only 2, only 3, 4 or more DMARDs) were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. Percentage of participants receiving only 3 DMARDs was determined for each cluster of participants.|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 clusters receiving only 3 DMARDs who reported themselves as being very satisfied, satisfied, or not satisfied. n=number of participants receiving only 3 DMARDs who reported themselves as very satisfied, satisfied , or not satisfied for the specified treatment arm.||percentage of participants|||Number
739811|NCT00459706|Secondary|Percentage of Participants Receiving Only 2 DMARDs Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, all participants receiving DMARDs (only 1, only 2, only 3, 4 or more DMARDs) were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. Percentage of participants receiving only 2 DMARDs was determined for each cluster of participants.|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 clusters receiving only 2 DMARDs, who reported themselves as very satisfied, satisfied, or not satisfied. n=number of participants receiving only 2 DMARDs who reported themselves as being very satisfied, satisfied , or not satisfied for the specified treatment arm.||percentage of participants|||Number
739812|NCT00459706|Secondary|Percentage of Participants Receiving Only 1 DMARD Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, all participants receiving DMARDs (only 1, only 2, only 3, 4 or more DMARDs) were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. Percentage of participants receiving only 1 DMARD was determined for each cluster of participants.|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 clusters receiving only 1 DMARD who reported themselves as being very satisfied, satisfied, or not satisfied. n=number of participants who reported themselves as being very satisfied, satisfied , or not satisfied for the specified treatment arm and cluster.||percentage of participants|||Number
739813|NCT00459706|Secondary|HAQ-DI Score Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. The mean HAQ-DI Score, assessing the extent of functional ability, was determined for each cluster of participants. Disability score ranged from 0=normal or no difficulty to 3=unable to do. Lower HAQ-DI scores indicated better health.|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 clusters who reported themselves as being very satisfied, satisfied, or not satisfied. n=number of participants who reported themselves as being very satisfied, satisfied, or not satisfied for the specified treatment arm and cluster.||units on a scale||Standard Deviation|Mean
739814|NCT00459706|Secondary|Physician's Global Assessment of RA Activity Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. Mean Physician's Global Assessment of RA Activity was determined for each cluster of participants. VAS scores ranged from 0 (inactive) to 100 mm (extremely active).|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 clusters who reported themselves as being very satisfied, satisfied, or not satisfied. n=number of participants who reported themselves as being very satisfied, satisfied, or not satisfied for the specified treatment arm and cluster.||millimeters on the VAS||Standard Deviation|Mean
739815|NCT00459706|Secondary|Participant's Global Assessment of RA Activity Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. Participants' mean Global Assessment of RA Activity was determined for each cluster of participants. VAS scores ranged from 0 (inactive) to 100 mm (extremely active).|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 clusters who reported themselves as being very satisfied, satisfied, or not satisfied. n=number of participants who reported themselves as being very satisfied, satisfied, or not satisfied for the specified treatment arm and cluster.||millimeters on the VAS||Standard Deviation|Mean
739838|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 17, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How You Feel When Using the Device - Q17: Overall, How Nervous Do You Feel about Inserting the Needle into Your Skin? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.|Day 84|mITT. N=participants with evaluable data.||percentage of participants|||Number
739816|NCT00459706|Secondary|DAS28 Score Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. The mean DAS28 Score was determined for each cluster of participants. Score ranged from 0 to 9.4. Interpretation: disease activity is low when score ≤3.2, moderate when 3.2<score≤5.1, or high when score >5.1, remission when score <2.6.|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 clusters who reported themselves as being very satisfied, satisfied, or not satisfied. n=number of participants who reported themselves as being very satisfied, satisfied, or not satisfied for the specified treatment arm and cluster.||units on a scale||Standard Deviation|Mean
739817|NCT00459706|Secondary|RA Duration Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. The mean RA Duration was determined for each cluster of participants.|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 clusters who reported themselves as being very satisfied, satisfied, or not satisfied. n=number of participants who reported themselves as being very satisfied, satisfied , or not satisfied for the specified treatment arm and cluster.||years||Standard Deviation|Mean
739818|NCT00459706|Secondary|Percentage of Participants With Prior Self-Injection Experience Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. The percentage of participants with prior self-injection experience was determined for each cluster of participants.|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 clusters who reported themselves as being very satisfied, satisfied, or not satisfied. n=number of participants who reported themselves as being very satisfied, satisfied, or not satisfied for the specified treatment arm and cluster.||percentage of participants|||Number
739819|NCT00459706|Secondary|Percentage of Participants With Prior Injection Experience Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. The percentage of participants with prior injection experience was determined for each cluster of participants.|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 clusters who reported themselves as being very satisfied, satisfied, or not satisfied. n=number of participants who reported themselves as being very satisfied, satisfied, or not satisfied for the specified treatment arm and cluster.||percentage of participants|||Number
739820|NCT00459706|Secondary|PAM Score Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. The mean PAM Score was determined for each cluster of participants. Calibrated PAM scale score ranged from 0 to 100.Higher scores indicated more confidence in managing participants' condition and lifestyle.|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 clusters who reported themselves as being very satisfied, satisfied, or not satisfied. n=number of participants who reported themselves as being very satisfied, satisfied, or not satisfied for the specified treatment arm and cluster.||units on a scale||Standard Deviation|Mean
739821|NCT00459706|Secondary|HAD Depression Subscale Score Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. The mean HAD Depression Subscale Score was determined for each cluster of participants. Score ranged from 0 to 21. Lower scores indicated better health.|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 clusters who reported themselves as being very satisfied, satisfied, or not satisfied. n=number of participants who reported themselves as being very satisfied, satisfied, or not satisfied for the specified treatment arm and cluster.||units on a scale||Standard Deviation|Mean
739822|NCT00459706|Secondary|HAD Anxiety Subscale Score Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. The mean HAD Anxiety Subscale Score was determined for each cluster of participants. Score ranged from 0 to 21. Lower scores indicated better health.|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 clusters who reported themselves as being very satisfied, satisfied, or not satisfied. n=number of participants who reported themselves as being very satisfied, satisfied, or not satisfied for the specified treatment arm and cluster.||units on a scale||Standard Deviation|Mean
739823|NCT00459706|Secondary|Percentage of Participants at University Level Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants in all 3 social-educational level (only reading/writing capacity, high-school level, university level) were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. Percentage of participants at the university level was determined for each cluster of participants.|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 social-educational levels and across all 3 clusters who reported themselves as very satisfied, satisfied, or not satisfied. n=participants across all 3 levels reporting themselves as very satisfied, satisfied, or not satisfied for the specified treatment arm.||percentage of participants|||Number
739824|NCT00459706|Secondary|Percentage of Participants at High School/Baccalaureate Level Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants in all 3 social-educational level (only reading/writing capacity, high-school level, university level) were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. Percentage of participants at high school/baccalaureate level was determined for each cluster of participants.|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 social-educational levels and across all 3 clusters who reported themselves as very satisfied, satisfied, or not satisfied. n=participants at all 3 levels reporting themselves as very satisfied, satisfied, or not satisfied for the specified treatment arm.||percentage of participants|||Number
739825|NCT00459706|Secondary|Percentage of Participants With Only Reading/Writing Capacity Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants in all 3 social-educational level (only reading/writing capacity, high-school level, university level) were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. Percentage of participants with only reading/writing capacity was determined for each cluster of participants.|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 social-educational levels and across all 3 clusters who reported themselves as very satisfied, satisfied, or not satisfied. n=participants across all 3 levels reporting themselves as very satisfied, satisfied, or not satisfied for the specified treatment arm.||percentage of participants|||Number
739826|NCT00459706|Secondary|Percentage of Female Participants Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, all male and female participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. Percentage of participants who were female was determined for each cluster of participants.|Day 84|mITT. Number of participants analyzed (N)=total number of participants (male+female) across all 3 clusters who reported themselves as being very satisfied, satisfied, or not satisfied. n=number of participants (male+female) who reported themselves as being very satisfied, satisfied, or not satisfied for the specified treatment arm and gender.||percentage of female participants|||Number
739827|NCT00459706|Secondary|Percentage of Male Participants Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, all male and female participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. The percentage of participants who were male was determined for each cluster of participants.|Day 84|mITT. n=number of participants (male plus female) who reported themselves as being very satisfied, satisfied, or not for the specified treatment arm.||percentage of male participants|||Number
739828|NCT00459706|Secondary|Age Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. The mean age was determined for each cluster of participants.|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 age clusters who reported themselves as being very satisfied, satisfied, or not satisfied. n=number of participants who reported themselves as being very satisfied, satisfied, or not satisfied for the specified treatment arm.||years||Standard Deviation|Mean
739829|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 26, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Likely Is It That You Would Use the Device Again - Q26: If Your Doctor Advised You to, How Likely Would You to Be Continue Injecting Regularly With this Device? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very likely.|Day 84|mITT. N=participants with evaluable data.||percentage of participants|||Number
739830|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 25, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Likely Is It That You Would Use the Device Again - Q25: Would You Recommend this Device to Someone Else Who Needed to Self Inject? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=yes definitely.|Day 84|mITT. N=participants with evaluable data.||percentage of participants|||Number
739831|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 24, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Likely Is It That You Would Use the Device Again - Q24: To What Extent Would You Consider Alternative Devices If You Were to Continue on Etanercept? Participants specified their responses on a 5-point Likert scale: 0=very little to 4=very much.|Day 84|mITT. N=participants with evaluable data.||percentage of participants|||Number
739832|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 23, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: Side Effects from Using the Device - Q23: Do You Experience Pain During or Immediately After the Injection? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.|Day 84|mITT. N=participants with evaluable data.||percentage of participants|||Number
739833|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 22, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: What Characteristics of the Device You Appreciate - Q22: How Much Does the Device Look Like Something You Would Feel Comfortable to Use? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.|Day 84|mITT. N=participants with evaluable data.||percentage of participants|||Number
739881|NCT00459810|Secondary|Time to Death|Defined as time from Day 1 of study regimen to Date of death from any cause.|Measured at Date of Death from any cause|||Months||95% Confidence Interval|Median
739839|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 16, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How You Feel When Using the Device - Q16: Overall, How Nervous Do You Feel about Your Injections? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.|Day 84|mITT. N=participants with evaluable data.||percentage of participants|||Number
739840|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 15, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Confident You Feel When Using the Device - Q15: How Confident Are You That You Injected Yourself Successfully? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.|Day 84|mITT. N=participants with evaluable data.||percentage of participants|||Number
739841|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 14, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Confident You Feel When Using the Device - Q14: Are You Confident That You Have Good Control over the Injection Process? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.|Day 84|mITT. N=participants with evaluable data.||percentage of participants|||Number
739842|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 13, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Confident You Feel When Using the Device - Q13: How Confident Are You That You Can Inject Yourself Properly with the Device? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.|Day 84|mITT. N=participants with evaluable data.||percentage of participants|||Number
739843|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 12, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Confident You Feel When Using the Device - Q12: How Confident Are You That You Inject the Right Amount of Medicine Every Time? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.|Day 84|mITT. N=participants with evaluable data.||percentage of participants|||Number
739844|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 11, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Confident You Feel When Using the Device - Q11: Overall, How Confident Are You in Your Management of Your Weekly Injections? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.|Day 84|mITT. N=participants with evaluable data.||percentage of participants|||Number
739845|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 10, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Convenient You Find the Device Is to Use - Q10: How Much Do You Think Injecting Etanercept Will Interfere with Travelling on Holiday/ Business/Visiting? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.|Day 84|mITT. N=participants with evaluable data.||percentage of participants|||Number
739846|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 9, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Convenient You Find the Device Is to Use - Q9: Do You Think Injecting Etanercept Will Interfere with Your Usual Daily Activities? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.|Day 84|mITT. N=participants with evaluable data.||percentage of participants|||Number
739847|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 8, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Convenient You Find the Device Is to Use - Q8: How Much Do You Think Injecting Etanercept Will Interfere with Your Ability to Enjoy Social or Leisure Activities? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.|Day 84|mITT. N=participants with evaluable data.||percentage of participants|||Number
739848|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 7, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Easy You Find the Device Is to Use - Q7: How Long Does It Take to Perform the Injection, Including any Preparation and Disposal? Participants specified their responses on a 5-point Likert scale: 0=<5 minutes to 4=>30 minutes.|Day 84|mITT. N=participants with evaluable data.||percentage of participants|||Number
739849|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 6, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Easy You Find the Device Is to Use - Q6: Did You Feel any Hand Discomfort Whilst Using the Device? Participants specified their responses on a 5-point Likert scale: 0=very easy to 4=very difficult.|Day 84|mITT. N=participants with evaluable data.||percentage of participants|||Number
739850|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 5, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Easy You Find the Device Is to Use - Q5: How Easy Is It to Hold the Device Whilst Injecting? Participants specified their responses on a 5-point Likert scale: 0=very easy to 4=very difficult.|Day 84|mITT. N=participants with evaluable data.||percentage of participants|||Number
739851|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 4, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Easy You Find the Device Is to Use - Q4: How Easy Is It to Know When the Injection Is Completed? Participants specified their responses on a 5-point Likert scale: 0=very easy to 4=very difficult.|Day 84|mITT. N=participants with evaluable data.||percentage of participants|||Number
739852|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 3, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Easy You Find the Device Is to Use - Q3: How Easy Is It to Dispose Of the Device? Participants specified their responses on a 5-point Likert scale: 0=very easy to 4=very difficult.|Day 84|mITT. N=participants with evaluable data.||percentage of participants|||Number
739853|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 2, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Easy You Find the Device Is to Use - Q2: How Easy Was It to Learn to Use the Device? Participants specified their responses on a 5-point Likert scale: 0=very easy to 4=very difficult.|Day 84|mITT. N=participants with evaluable data.||percentage of participants|||Number
739854|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 1, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Easy You Find the Device Is to Use - Q1: Overall, How Easy Was It to Perform an Injection with this Device? Participants specified their responses on a 5-point Likert scale: 0=very easy to 4=very difficult.|Day 84|mITT. N=participants with evaluable data.||percentage of participants|||Number
739855|NCT00459706|Secondary|Device Attributes and Participant Perception Questionnaire: How Satisfied Is the Subject With All the Treatments He/She is Currently Receiving for RA?|"Score indicated satisfaction in response to the question How satisfied are you with all the treatments you are currently receiving for your rheumatoid arthritis? Score ranged from 0=completely dissatisfied to 10=completely satisfied. Higher scores indicated greater satisfaction."|Day 84|mITT. N=number of evaluable participants.||units on a scale||Standard Deviation|Mean
739856|NCT00459706|Secondary|Device Attributes and Participant Perception Questionnaire: How Satisfied Is the Subject With His/Her Health?|"Score indicated satisfaction in response to the question How satisfied are you with your health? Score ranged from 0=completely dissatisfied to 10=completely satisfied. Higher scores indicated greater satisfaction."|Day 84|mITT. N=number of evaluable participants.||units on a scale||Standard Deviation|Mean
739857|NCT00459706|Secondary|Device Attributes and Participant Perception Questionnaire: How Satisfied Is the Subject With His/Her Life as a Whole?|"Score indicated satisfaction in response to the question Thinking about your own life and personal circumstances, how satisfied are you with your life as a whole? Score ranged from 0=completely dissatisfied to 10=completely satisfied. Higher scores indicated greater satisfaction."|Day 84|mITT. N=number of evaluable participants.||units on a scale||Standard Deviation|Mean
739858|NCT00459706|Secondary|Short Form of the State-Trait Anxiety Inventory (SF-STAI) Global Score|The SF-STAI consisted of 6 questions, each scored from 1 to 4. Total score ranged from 6=less anxiety to 24=more anxiety. Higher score indicated that the participant was more anxious.|Day 84|mITT. N=number of evaluable participants.||units on a scale||Standard Deviation|Mean
739859|NCT00459706|Secondary|Participant Satisfaction by Prior Injection Experience for 2 Different Delivery Mechanisms for Etanercept|Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Participants were grouped into 2 categories: those who did and did not have prior injection experience. Higher scores indicated greater satisfaction with the delivery mechanism.|Day 84|mITT; LOCF. n=evaluable participants in that category.||units on a scale||Standard Deviation|Mean
739860|NCT00459706|Secondary|Participant Satisfaction by Maximum Combination of Disease-Modifying Antirheumatic Drug (DMARD) Use for 2 Different Delivery Mechanisms for Etanercept|Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the delivery mechanism. Participants were categorized into those who received only 1 DMARD, only 2 DMARDs, only 3 DMARDs, and at least 3 DMARDs.|Day 84|mITT; LOCF. N=total evaluable participants. n=total evaluable participants for that category.||units on a scale||Standard Deviation|Mean
739861|NCT00459706|Secondary|Participant Satisfaction by Health Assessment Questionnaire - Disability Index (HAQ-DI) for 2 Different Delivery Mechanisms for Etanercept|Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism. The 20-item HAQ-DI assessed the extent of participants' functional ability. Calculation yielded a single disability score from 0=normal or no difficulty to 3=unable to do. Lower HAQ-DI scores indicated better health. Results are reported by categories of HAQ-DI scores observed: <=0.9, >0.9-1.4, >1.4-1.9, >1.9.|Day 84|mITT; LOCF.||units on a scale||Standard Deviation|Mean
739862|NCT00459706|Secondary|Participant Satisfaction by Physician's Global Assessment of RA Activity for 2 Different Delivery Mechanisms for Etanercept|Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism. Physicians' global assessment of disease activity was measured on a VAS ranging from 0 (inactive) to 100 mm (extremely active). Results are reported by VAS scores observed for physician's global assessment of RA activity: <=47 mm, >47-61 mm, >61-72 mm, >72 mm.|Day 84|mITT; LOCF.||units on a scale||Standard Deviation|Mean
739863|NCT00459706|Secondary|Participant Satisfaction by Participant's Global Assessment of RA Activity for 2 Different Delivery Mechanisms for Etanercept|Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the delivery mechanism. Participants' global assessment of disease activity was measured on a visual analog scale (VAS) ranging from 0 (inactive) to 100 millimeter (mm) (extremely active). Results are reported by VAS scores observed for the participant's global assessment of RA activity: <=50 mm, >50-67 mm, >67-79 mm, >79 mm.|Day 84|mITT; LOCF.||units on a scale||Standard Deviation|Mean
739864|NCT00459706|Secondary|Participant Satisfaction by 28-joint Disease Activity Score (DAS28) for 2 Different Delivery Mechanisms for Etanercept|Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the delivery mechanism. DAS28 includes a 28 tender joint count, a 28 swollen joint count, erythrocyte sedimentation rate, and a general health assessment on a visual analog scale. Score ranged from 0 to 9.4. Interpretation: disease activity is low when score ≤3.2, moderate when 3.2<score≤5.1, or high when score >5.1, remission when score <2.6. Results are reported by categories of DAS28 score: <=4.7, >4.7-5.4, >5.4-6.2, >6.2.|Day 84|mITT; LOCF.||units on a scale||Standard Deviation|Mean
739865|NCT00459706|Secondary|Participant Satisfaction by Duration of Rheumatoid Arthritis (RA) for 2 Different Delivery Mechanisms for Etanercept|Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the delivery mechanism. Results are reported by duration of RA: <=3 years, >3-6 years, >6-13 years, >13 years.|Day 84|mITT; LOCF.||units on a scale||Standard Deviation|Mean
739866|NCT00459706|Secondary|Participant Satisfaction by Prior Self-Injection Experience for 2 Different Delivery Mechanisms for Etanercept|Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Participants were grouped into 2 categories: those who did and did not have prior self-injection experience. Higher scores indicated greater satisfaction in the delivery mechanism.|Day 84|mITT; LOCF. N=total evaluable participants. n=evaluable participants for that category.||units on a scale||Standard Deviation|Mean
739867|NCT00459706|Secondary|Participant Satisfaction by Patient Activation Measure (PAM) Score for 2 Different Delivery Mechanisms for Etanercept|Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the delivery mechanism. The 13-item short form of the PAM survey assessed participants' knowledge, skill, and confidence for self-management; calibrated scale score ranged from 0 to 100. Higher scores indicated more confidence in managing participants' condition and lifestyle. Results reported by PAM score: <=49.9, >49.9-56.4, >56.4-66, >66.|Day 84|mITT; LOCF.||units on a scale||Standard Deviation|Mean
739868|NCT00459706|Secondary|Participant Satisfaction by the HAD Depression Subscale Score for 2 Different Delivery Mechanisms for Etanercept|Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism. The HAD scale assessed participants' levels of anxiety and depression over the past week; total 14 questions, even-numbered questions related to depression. Responses scored on a 4-point scale; each question was graded in a different way. Depression subscale scores ranged from 0 to 21. Lower HAD Depression subscale scores indicated better health. Categories are depression subscale scores.|Day 84|mITT; LOCF.||units on a scale||Standard Deviation|Mean
739869|NCT00459706|Secondary|Participant Satisfaction by the Hospital Anxiety Depression (HAD) Anxiety Subscale Score for 2 Different Delivery Mechanisms for Etanercept|Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism. The HAD scale assessed participants' levels of anxiety and depression over the past week; total 14 questions, odd-numbered questions related to anxiety. Responses scored on a 4-point scale; each question was graded in a different way. Anxiety subscale scores ranged from 0 to 21. Lower HAD Anxiety subscale scores indicated better health. Categories are anxiety subscale scores.|Day 84|mITT; LOCF.||units on a scale||Standard Deviation|Mean
739870|NCT00459706|Secondary|Participant Satisfaction by Socio-Educational Level for 2 Different Delivery Mechanisms for Etanercept|Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism. Participants were categorized into those having only reading/writing capacity, those at the high-school/baccalaureate level, and those at the university level.|Day 84|mITT; LOCF. N=total participants with evaluable data. n=participants with evaluable data for that category.||units on a scale||Standard Deviation|Mean
739871|NCT00459706|Secondary|Participant Satisfaction by Gender for 2 Different Delivery Mechanisms for Etanercept|Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism.|Day 84|mITT; LOCF. N=total evaluable participants. n=participants evaluable in that category.||units on a scale||Standard Deviation|Mean
739872|NCT00459706|Secondary|Participant Satisfaction by Age for 2 Different Delivery Mechanisms for Etanercept|Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism. Results are reported by age categories: <=46 years, >46-55 years, >55-65 years, >65 years.|Day 84|mITT; last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
739873|NCT00459706|Secondary|Percentage of Participants on Day 84 Satisfied With Either of the Delivery Mechanisms for Etanercept|"Percentage of participants answering Yes to the question Are you satisfied with your injection device?"|Day 84|mITT. N=participants with evaluable data.||percentage of participants|||Number
739874|NCT00459706|Secondary|Percentage of Participants on Day 28 Satisfied With Either of the Different Delivery Mechanisms for Etanercept|"Percentage of participants answering Yes to the question Are you satisfied with your injection device?"|Day 28|mITT. N=participants with evaluable data.||percentage of participants|||Number
739875|NCT00459706|Primary|Participant Satisfaction on Day 84 for 2 Different Delivery Mechanisms for Etanercept, Per-Protocol Population|"Participant's response to the question How satisfied are you with your injection device? scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher score indicated greater satisfaction with the delivery mechanism."|Day 84|Per-protocol (PP): mITT participants who completed the study with no major protocol violation. N=participants with evaluable data.||units on a scale||Standard Deviation|Mean
739876|NCT00459706|Primary|Participant Satisfaction on Day 84 for 2 Different Delivery Mechanisms for Etanercept, Modified Intent-to-treat Population|"Participant's response to the question How satisfied are you with your injection device? scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher score indicated greater satisfaction with the delivery mechanism."|Day 84|Modified Intent-to-Treat (mITT): All randomized participants who received at least 1 injection of test article and had at least 1 available evaluation after the first administration of test article. Number of participants analyzed (N) = participants with evaluable data.||units on a scale||Standard Deviation|Mean
739877|NCT00459732|Secondary|Osteocalcin, a Marker of Bone Formation|Absolute change in serum osteocalcin between 0 and 18 months, intention to treat analysis between the zinc and placebo groups|Baseline to 18 months|Intention to treat analysis||ng/mL||Standard Deviation|Mean
739878|NCT00459732|Primary|Change in Whole Body Bone Mineral Content (BMC) by DXA (Baseline to 18 Months)||Baseline to 18 months|Intention to treat analysis in those who completed the 18 month timepoint (zinc vs. placebo)||Percent change||Standard Deviation|Mean
739879|NCT00459732|Primary|Change in Lumbar Spine Bone Mineral Density (BMD) by DXA (Baseline to 18 Months)|Change in pa spine bone mineral density by DXA between baseline and 18 months|0 to 18 months|Intention to treat analysis of all subjects who completed the protocol in each arm of the study (zinc vs. placebo).||Percent Change||Standard Deviation|Mean
739880|NCT00459810|Secondary|Correlation of Levels of Serum Estradiol, Serum Cathepsin B, and Bone Turnover Markers With PSA Response|These correlative analyses were not completed. As there were no PSA responses, it was not possible to correlate serum estradiol, serum cathepsin B, or bone turnover markers with PSA response.|Measured after 4 cycles of combination therapy||||||
739885|NCT00459862|Secondary|Overall Response Rate|"To evaluate the confirmed response rate of pazopanib in patients with MPM based on the RECIST criteria for MPM. Responses are confirmed by repeat assessments that are be performed no less than 4 weeks after the criteria for response are first met.
Complete Response (CR): Disappearance of all target lesions.
Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD."|Participants will be evaluated every cycle during treatment, up to 2 years|All 34 participants were evaluable for this endpoint.||percentage of patients||95% Confidence Interval|Number
739886|NCT00459862|Secondary|Overall Best Response of Target Lesions to Pazopanib in Patients With MPM Based on the RECIST.|"Complete Response (CR): Disappearance of all target lesions.
Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline LD."|From study enrollment to the first date of disease progression|All 34 participants were evaluable for this endpoint.||participants|||Number
739887|NCT00459862|Secondary|Determine the Clinical Toxicities of This Drug in This Participant Population.|The number of participants with a reported Grade 3, Grade 4, and Grade 5 toxicity, regardless of attribution, will be tabulated.|Participants will be evaluated every cycle during treatment|All 34 participants were evaluable for adverse events.||participants|||Number
739888|NCT00459862|Secondary|Progression-free Survival Assessed by RECIST||From study enrollment to the first date of disease progression or death as a result of any cause, whichever occurs first, up to 3 years|All 34 participants were analyzed for this endpoint.||months||95% Confidence Interval|Median
739889|NCT00459862|Secondary|Overall Survival||From study enrollment to time of death from any cause or censored at last follow-up, up to 3 years|All 34 participants were evaluable for this endpoint.||months||95% Confidence Interval|Median
739890|NCT00459862|Primary|Proportion of Evaluable Participants Who Are Progression-free at 6 Months Based on the Response Evaluation Criteria for Solid Tumors (RECIST)|The proportion of patients who are progression-free at 6 months is calculated by dividing the number of evaluable participants who are progression-free at 6 months based on the Response Evaluation Criteria for Solid Tumors (RECIST) by the total number of evaluable participants.|6 months|All 34 participants were analyzed for this endpoint.||percentage of participants|||Number
739891|NCT00459875|Primary|Overall Objective Response Rate as Measured by RECIST||2 years|||participants|||Number
739892|NCT00459953|Primary|Point Prevalence Abstinence|Point prevalence abstinence is defined as a report of nonsmoking (not even a puff) for 7 consecutive days prior to assessment and an expired-air carbon monoxide level below 9 parts per million (ppm)|6 months|||participants|||Number
739893|NCT00459979|Secondary|Median Size Reduction Among Tumors With Some Shrinkage|The median size reduction in the largest diameter of the primary RCC tumor among the tumors with at least some shrinkage in diameter|1 year from start of treatment|||cm|Participants|Full Range|Median
739894|NCT00459979|Secondary|Number of Tumors With 30% Reduction in Size|Number of tumors with at least 30% reduction in longest primary tumor diameter. Response was unconfirmed by RECIST criteria because patients went to surgery and did not undergo follow-up scans.|1 year from start of treatment|per protocol- after at least one cycle of Sunitinib||tumors|Participants||Number
739895|NCT00459979|Secondary|Number of Tumors Which Decreased in Size|Number of tumors with at least some reduction in longest primary tumor diameter. Response was unconfirmed by RECIST criteria because patients went to surgery and did not undergo follow-up scans.|1 year from start of treatment|per protocol - after at lease one cycle of Sunitinib||tumors|Participants||Number
739896|NCT00459979|Secondary|Percent Decrease of Diameter of Primary Tumors|Median percent decrease in size in all primary renal cell carcinoma tumors. Response was unconfirmed by RECIST criteria because patients went to surgery and did not undergo follow-up scans.|1 year from start of treatment|per protocol - analysis after at least one cycle of Sunitinib||percentage of tumors diameter decrease|Participants|Full Range|Median
739897|NCT00459979|Secondary|Progression Free Survival|Progression free survival is defined as the amount of time (in months) between the start of treatment and documented RECIST defined progression. RECIST progression is defined as at least a 20% increase in the sum of diameters of target lesions, in addition to an absolute increase of at least 5mm.|1 year from start of treatment|||months||Full Range|Median
739898|NCT00459979|Secondary|The Number of Patients With Any Type of Complication or Adverse Event|The safety of sunitinib will be assessed by recording the number of patients with any type of complication or adverse event within 1 year of the start of therapy.|1 year from start of treatment|||participants|||Number
739899|NCT00459979|Primary|Response to Sunitinib Therapy|Defined as a reduction in tumor burden to such an extent that nephrectomy is permitted within 1 year of the start of therapy. No response to sunitinib therapy is defined as a nephrectomy not being permitted within 1 year of the start of therapy or removal from the study for any reason|1 year from start of treatment|per protocol - analysis after at least one cycle of Sunitinib||participants|||Number
739900|NCT00460031|Secondary|Ratio of Change in Immune Response From Baseline|The pattern of immune response by assessing T cell and dendritic cell markers, specifically by measuring the ratio of BDCA-2 to BDCA-1 cells|Week 8|All patients who completed the study||ratio||Standard Deviation|Mean
739901|NCT00460031|Secondary|Change in Immune Response From Baseline|The pattern of immune response by assessing T cell and dendritic cell markers, specifically by measuring the levels of CD4+ FoxP3+ Regulatory T cells|Week 8|All patients who completed the study||cells/ul||Standard Deviation|Mean
739902|NCT00460031|Secondary|Number of Patients With Grade 3 and 4 Toxicity as Assessed by NCI CTCAE v3.0|Patients will be evaluated for toxicity every 2 weeks during the first cycle. Thereafter, evaluations will be done every 28 days or more frequently if clinically indicated.|Up to 30 days after discontinuation of treatment|All patients who received at least one treatment in the study||participants|||Number
739903|NCT00460031|Secondary|Time to Progression|Patients will be evaluated for clinical benefit monthly with PSA values.Patients who are benefiting from treatment are eligible for additional cycles of treatment. Thereafter, therapy will continue until criteria for progressive disease are met. Response is based on the RECIST criteria from the National Cancer institute. Complete Response (CR) disappearance of all target lesions; Partial Response (PR) >= 30% decrease in the sum of the longest diameter of target lesions from baseline; Progressive Disease (PD) >= increase in the sum of the longest diameter of target lesions from baseline; Stable Disease (SD) neither sufficient for partial response nor sufficient increase for progressive disease.|One year (12 months) after start of treatment|Patients with disease progression||Months||95% Confidence Interval|Median
739904|NCT00460031|Primary|Number of Patients With a Partial Response, Progressive Disease, or Stable Disease Based on Prostate-Specific Antigen (PSA) or Measurable Disease|Patients will be evaluated for clinical benefit monthly with PSA values.Patients who are benefiting from treatment are eligible for additional cycles of treatment. Thereafter, therapy will continue until criteria for progressive disease are met. Response is based on the RECIST criteria from the National Cancer institute. Complete Response (CR) disappearance of all target lesions; Partial Response (PR) >= 30% decrease in the sum of the longest diameter of target lesions from baseline; Progressive Disease (PD) >= increase in the sum of the longest diameter of target lesions from baseline; Stable Disease (SD) neither sufficient for partial response nor sufficient increase for progressive disease.|28 days|All patients who completed the study||participants|||Number
739905|NCT00460993|Primary|Sleep Efficiency|Percentage of time in bed at night asleep, averaged over 3 nights, as measured by actigraphy (and by polysomnography in a subgroup of subjects), holding constant time in bed and recording time|6 days|||percentage of sleep||Full Range|Median
739906|NCT00461032|Secondary|Percentage of Days With Increased Daytime Asthma Symptom Score by >50% From Baseline (as Measured on Daily Diaries) in Pediatric Asthmatic Participants|Daytime asthma symptom score was calculated as the sum of the responses (0 (best) to 5 (worst)) to three daytime symptom questions.|8 Week treatment period initiated at the beginning of a school year|The secondary efficacy analysis was based on full-analysis-set (FAS) population. This included all randomized participants who received at least one dose of double-blinded therapy and had a valid efficacy measurement. Variables that were measured as the average over the treatment period were defined from at least 7 days of evaluable diary data.||Percentage of Days||95% Confidence Interval|Least Squares Mean
739907|NCT00461032|Secondary|Percentage of Days With Increased β-agonist Use by >70% and a Minimum Increase of 2 Puffs From Baseline (as Measured on Daily Diaries) in Pediatric Asthmatic Participants||8 Week treatment period initiated at the beginning of a school year|The secondary efficacy analysis was based on full-analysis-set (FAS) population. This included all randomized participants who received at least one dose of double-blinded therapy and had valid efficacy measurement for at least 7 days of diary data.||Percentage of Days||95% Confidence Interval|Least Squares Mean
739908|NCT00461032|Secondary|Number of Participants With the Occurrence of One or More Health Care Utilizations (as Measured on Daily Diaries)|Health care utilization is defined as unanticipated asthma care in an office or clinic, emergent or hospital setting.|8 Week treatment period initiated at the beginning of a school year|The analysis was based on the FAS population. This included all randomized participants who received at least 1 dose of study medication and had a valid efficacy measurement. Occurrence of one or more health care utilization was derived from the available diary data and was set to missing if no diary data were available.||Participants|||Number
739909|NCT00461032|Primary|Mean Percentage of Days With Worsening Asthma (as Measured on Daily Diaries) in Pediatric Asthmatic Participants|"A day of worsening asthma is a day with: increase from baseline in β-agonist use (> 70% and a min increase of 2 puffs); > 50% increase from baseline in daytime symptoms score; awake all night; increase from baseline in inhaled corticosteroid use ≥ 100% or oral corticosteroid rescue for worsening asthma; or unanticipated healthcare utilization."|8 Week treatment period initiated at the beginning of a school year|The primary efficacy analysis was based on full-analysis-set (FAS) population. This included all randomized participants who received at least one dose of double-blinded therapy and had a valid efficacy measurement. The percent of worsening asthma days was calculated from at least 7 days of diary data. Missing diary data were not imputed.||Percentage of Days||95% Confidence Interval|Least Squares Mean
739910|NCT00461045|Secondary|Maximum Observed Blood Drug Concentration (Cmax)||Samples collected on Cycle 1 Day 1 and Cycle 1 Day 11.|The sponsor elected not to analyze the pharmacokinetic (PK) samples collected, therefore, no PK results are obtained.|||||
739911|NCT00461045|Secondary|Number of Treatment Emergent Adverse Events (TEAEs)|"Adverse events were graded using NCI-CTCAE (version 4.3). TEAEs are defined as any adverse event with an onset date between the date of first dose and 30 days after the date of last dose of any study drug.
Treatment-related adverse events are adverse events considered related to at least one study drug by the investigator (NPI-002, dexamethasone), including those with unknown relationship."|Through study completion, an average of 6.09 weeks.|||TEAEs|||Number
739912|NCT00461045|Secondary|Number of Patients With Treatment Emergent Adverse Events (TEAEs)|"Adverse events were graded using NCI-CTCAE (version 4.3). TEAEs are defined as any adverse event with an onset date between the date of first dose and 30 days after the date of last dose of any study drug.
Treatment-related adverse events are adverse events considered related to at least one study drug by the investigator (NPI-002, dexamethasone), including those with unknown relationship."|Through study completion, an average of 6.09 weeks.|||Participants|||Count of Participants
739913|NCT00461045|Secondary|Number of Patients Receiving Marizomib (MRZ) in Each Cycle|A patient was counted in a cycle if the patient received at least one dose of study drug during the cycle.|Through study completion, an average of 6.09 weeks.|||Participants|||Count of Participants
739914|NCT00461045|Secondary|Number of Cycles of Marizomib (MRZ)||Through study completion, an average of 6.09 weeks.|||cycles||Standard Deviation|Mean
739915|NCT00461045|Secondary|Duration of MRZ Treatment|Duration of treatment is defined as the last dose date minus the first dose date of the dose cohort plus 1 expressed in weeks.|Through study completion, an average of 6.09 weeks.|||weeks||Standard Deviation|Mean
739916|NCT00461045|Primary|Number of Patients Exhibiting a Given Overall Response as Determined by Investigator|Disease response and progression were determined by the investigator using the International Myeloma Working Group Uniform Response Criteria (IMWG-URC). Overall response rate includes patients with a best response of PR of better. Stringent complete response (CR) includes immunophenotypic CR and molecular CR in addition to stringent CR.|Through study completion, an average of 6.09 weeks.|||participants|||Number
739917|NCT00461097|Secondary|Percent of Participants in the Egg OIT Treatment Arm Who Successfully Consumed 10,000 mg of Egg White Solid|Tolerance Assessment: Participants in the Egg OIT treatment arm who were not tolerant at 2 years were offered an additional 2 years of therapy. A 10,000 mg double-blind placebo controlled oral food challenge to egg was done the same way as the one performed at 2 years for these participants in order to identify tolerant individuals in the 2 to 4 year extension segment. The tolerant individuals from this segment were then added to the tolerant individuals from the 2 year segment.|4 years (48 months)|||percentage of participants|||Number
739918|NCT00461097|Secondary|Number of Participants With Serious Adverse Events (SAEs)|This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.|Baseline through the 2-year primary endpoint|The intention to treat (ITT) population was used which included all subjects randomized to double-blind treatment.||participants|||Number
739919|NCT00461097|Secondary|Percent of Participants Who Achieved a Maintenance Dose of 2,000 mg|For participants whose maximum tolerated dose on the initial escalation day was less than 50 mg, doses were doubled every 2 weeks up to 50 mg. After 50 mg, dosing was increased to 75 mg, and then dosing increased by 25% until the 2000 mg dose was reached. The maximum time allowed for the build-up phase was 40 weeks; the dose achieved at 40 weeks was considered the maintenance dose.|Following the blinded desensitization phase at approximately Week 44|The intention to treat (ITT) population was used which included all subjects randomized to double-blind treatment.||percentage of participants|||Number
739920|NCT00461097|Secondary|Percent of Participants Who Successfully Consumed a 50 mg Dose at Initial Escalation|On the initial day of dosing, participants were offered 0.1 mg of egg white solid or placebo followed by an approximate doubling every 30 minutes up to a 50 mg dose providing limiting reactions do not occur.|Initial day of dosing|The intention to treat (ITT) population was used which included all subjects randomized to double-blind treatment.||percentage of participants|||Number
739921|NCT00461097|Secondary|Percent of Participants Who Successfully Consumed 5,000 mg of Egg White Solid|Desensitization assessment: Participants who successfully consumed without dose-limiting symptoms 5,000 mg of egg white solid during a double-blind placebo-controlled oral food challenge were counted as successes.|Following the blinded desensitization phase at approximately Week 44|The intention to treat (ITT) population was used which included all subjects randomized to double-blind treatment.||percentage of participants|||Number
739922|NCT00461097|Primary|Percent of Participants Who Successfully Consumed 10,000 mg of Egg White Solid Followed by Open Feeding of Egg|Tolerance Assessment: Participants who successfully consumed without dose-limiting symptoms 10,000 mg of egg white solid during a double-blind placebo-controlled oral food challenge were then given an open feeding of egg and those who successfully consumed the open feeding of egg were counted as successes.|At the 2 year time point; Egg OIT participants must be approximately 4-6 weeks post-discontinuation of therapy|The intention to treat (ITT) population was used which included all subjects randomized to double-blind treatment.||percentage of participants|||Number
739923|NCT00461123|Secondary|Duration of Surgery|Duration of prostate laser ablation, i.e. Greenlight(TM) laser surgery.|on the day of surgery, without any further allowable time window|"The intent-to-treat (ITT) population includes participants with baseline and post-baseline measurement of duration of surgery; imputation technique: last post-baseline observation carried forward (LOCF). The ITT population is not identical to the number of subjects who completed the study."||minutes||Standard Deviation|Mean
739924|NCT00461123|Secondary|Baseline-adjusted Least Squared (LS) Means of the Number of Urinary Incontinence Episodes Per Week at 3 Months After Surgery or Last Observation Carried Forward (LOCF)|Baseline (pre-surgery Day -1) adjusted LS-means at 3 months after surgery (Day +90, last observation carried forward (LOCF)) in the number of incontinence episodes. Urinary incontinence is an involuntary excretion (passing) of urine. Urinary incontinence episodes were collected in the patient diary.|baseline and up to 3 months after surgery|"The intent-to-treat (ITT) population includes participants with baseline and post-baseline documentation of number of incontinence episodes per week; imputation technique: last post-baseline observation carried forward (LOCF). The ITT population is not identical to the number of subjects who completed the study."||urinary incontinence episodes||Standard Deviation|Mean
739925|NCT00461123|Secondary|Baseline-adjusted Least Squared (LS) Means of Post-void Residual (PVR) Volume at 3 Months After Surgery or Last Observation Carried Forward (LOCF)|Baseline (pre-surgery Day -1) adjusted LS-means at 3 months after surgery (Day +90, last observation carried forward (LOCF)) in PVR volume. PVR is the amount of urine left in the bladder after a person has passed urine.|baseline and up to 3 months after surgery|"The intent-to-treat (ITT) population includes participants with baseline and post-baseline measurement of post-void residual (PVR) volume; imputation technique: last post-baseline observation carried forward (LOCF). The ITT population is not identical to the number of subjects who completed the study."||milliliter (mL)||Standard Deviation|Mean
739926|NCT00461123|Secondary|Baseline-adjusted Least Squared (LS) Means of International Prostate Symptom Score (IPSS) Total Score at 3 Months After Surgery or Last Observation Carried Forward (LOCF)|Baseline (pre-surgery Day -1) adjusted LS-means at 3 months after surgery (Day +90, LOCF) in IPSS total score. IPSS is a questionnaire on benign prostate hyperplasia, including seven 6-point items on symptoms and one 7-point item on quality of life. Total score: sum of items 1 through 7; minimum: 0 (best); maximum: 41 (worst).|baseline and up to 3 months after surgery|"The intent-to-treat (ITT) population includes participants with baseline and post-baseline measurement of International Prostate Symptom Score (IPSS) total score; imputation technique: last post-baseline observation carried forward (LOCF). The ITT population is not identical to the number of subjects who completed the study."||scores on a scale||Standard Deviation|Mean
739927|NCT00461123|Primary|Baseline-adjusted Least Squared (LS) Means of Peak Urinary Flow (Qmax) at 3 Months After Surgery or Last Observation Carried Forward (LOCF)|Baseline (pre-surgery Day -1) adjusted least squares (LS)-means at 3 months after surgery (Day +90, last observation carried forward (LOCF)) in peak urinary flow.|baseline and up to 3 months after surgery|"The intent-to-treat (ITT) population includes participants with baseline and post-baseline measurement of peak urinary flow; imputation technique: last post-baseline observation carried forward (LOCF). The ITT population is not identical to the number of subjects who completed the study, as displayed under Participants Flow."||milliliter per second (mL/s)||Standard Deviation|Mean
739928|NCT00461175|Other Pre-specified|Contraceptive Failure|Intrauterine contraceptive methods have low Pearl Indices. Nevertheless, there is a lack of comparative data between LNG IUS users and copper IUD users. Women with unintended pregnancies were explicitly aked whether the pregnancy occured despite IUD use. The 29 pregnancies that occured after unrecognized IUD expulsion were considered to have resulted from a failure of the contraceptive method and were therefore included in the analysis.|Within 12 months|||participants|||Number
740606|NCT00460525|Secondary|Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by ELISA at Day 240.|Titers of Anti-FMP2.1 antibody were determined by ELISA from sera collected at Day 240.|Day 240 after initial vaccination|Analyses are ITT. No imputation techniques were used.||Titer||95% Confidence Interval|Geometric Mean
739929|NCT00461175|Primary|Uterine Perforation Rate|Uterine perforation is a potentially serious complication of intrauterine device (IUD) use. The absolute risk of uterine perforation associated with the LNG IUS in routine medical practice has not hitherto been well defined. It is also unknown whether the perforation rate is higher with this IUD than with copper IUDs.|12 months after insertion|"Intention-to-treat (ITT) population. Number of Participants referring to the initially inserted IUS/IUD or the initial IUD insertion attempt."||participants|||Number
739930|NCT00461253|Primary|Breast Cancer Risk|Breast cancer (invasive carcinoma or carcinoma in situ) in women aged <50 years at diagnosis. Cases were excluded if they had died before study start or had a history of malignancy.|retrospective, January 2000 to December 2007|Frequency of breast cancer (in situ and invasive) in LNG-IUD users and Cu-IUD users||participants|||Number
739931|NCT00461292|Secondary|Change From Baseline in Total Score on Incontinence Quality of Life (I-QOL) Questionnaire|Change from baseline in I-QOL questionnaire total score at Week 6, as completed by the patient. The I-QOL is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure impact of urinary incontinence on patients’ lives. Each question is answered on a 5-point scale (1 = worst QOL, and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0=worst QOL and 100=best QOL). A positive change from baseline represents an improvement.|Baseline, Week 6|Intent-To-Treat, defined as all patients who started the study (randomized)||Number on a Scale (Score)||Standard Deviation|Mean
739932|NCT00461292|Secondary|Change From Baseline in Maximum Detrusor Pressure (MDP)|Change from baseline in MDP during the first involuntary detrusor contraction at week 6. MDP represents the maximum pressure (peak amplitude) in the bladder during the first involuntary contraction of the bladder muscle. The greater the negative number change from baseline, the better the improvement.|Baseline, Week 6|Intent-To-Treat, defined as all patients who started the study (randomized)||Centimeters of water (cm H2O)||Standard Deviation|Mean
739933|NCT00461292|Secondary|Change From Baseline in Maximum Cystometric Capacity (MCC)|Change from baseline in MCC at Week 6. MCC represents the maximum volume of urine the bladder holds. A positive number change from baseline represents an improvement (increase) in maximum volume of urine the bladder holds.|Baseline, Week 6|Intent-To-Treat, defined as all patients who started the study (randomized)||Milliliters (mL) of urine||Standard Deviation|Mean
739934|NCT00461292|Primary|Change From Baseline in Number of Weekly Episodes of Urinary Incontinence|Change from baseline in the weekly frequency of incontinence episodes at Week 6 after the first treatment. Incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).|Baseline, Week 6|Intent-To-Treat, defined as all patients who started the study (randomized)||Number of Weekly Episodes||Standard Deviation|Mean
739935|NCT00461305|Post-Hoc|Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 13|Total dysmenorrhea score was defined as sum of 2 sub-scores: severity of dysmenorrhea and use of analgesics. Higher score means it is more severe. 0=None, 6=Severest.|Baseline and up to Cycle 13 (364 days) with 28 days per cycle|FAS (note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)||scores on a scale||Standard Deviation|Mean
739936|NCT00461305|Post-Hoc|Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 6|Total dysmenorrhea score was defined as sum of 2 sub-scores: severity of dysmenorrhea and use of analgesics. Higher score means it is more severe. 0=None, 6=Severest.|Baseline and up to Cycle 6 (168 days) with 28 days per cycle|FAS||scores on a scale||Standard Deviation|Mean
739937|NCT00461305|Secondary|Change in Serum CRP From Baseline to Cycle 13|CRP is a laboratory parameter giving an indication of inflammation, whose elevated level suggests a potential inflammation.|From baseline up to Cycle 13 (364 days) with 28 days per cycle|FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)||mg/dL||Full Range|Mean
739938|NCT00461305|Secondary|Change in Serum C-reactive Protein (CRP) From Baseline to Cycle 6|CRP is a laboratory parameter giving an indication of inflammation, whose elevated level suggests a potential inflammation.|From baseline up to Cycle 6 (168 days) with 28 days per cycle|FAS(Participants with data at Cycle 6)||mg/dL||Full Range|Mean
739939|NCT00461305|Secondary|Change in Serum CA-125 From Baseline to Cycle 13|CA125 is a laboratory parameter giving an indication of having tumor, whose elevated levels that were defined by a lab suggest a potential tumor.|From baseline up to Cycle 13 (364 days) with 28 days per cycle|FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)||Units/mL||Full Range|Mean
739940|NCT00461305|Secondary|Change in Serum Carbohydrate Antigen-125 (CA-125) From Baseline to Cycle 6|CA125 is a laboratory parameter giving an indication of having tumor, whose elevated levels that were defined by a lab suggest a potential tumor.|From baseline up to Cycle 6 (168 days) with 28 days per cycle|FAS(Participants with data at Cycle 6)||Units/mL||Full Range|Mean
739941|NCT00461305|Secondary|Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 13|Non-heavy bleeding was defined as those other than heavy bleeding (i.e. spotting, light, or normal bleeding).|Up to Cycle 13 (364 days) with 28 days per cycle|FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)||Percentage of participants|||Number
739942|NCT00461305|Secondary|Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 6|Non-heavy bleeding was defined as those other than heavy bleeding (i.e. spotting, light, or normal bleeding).|Up to Cycle 6 (168 days) with 28 days per cycle|FAS (Participants with data at Cycle 6, values for Cycle 1 to Cycle 6 (Reference period 1 and Reference period 2) in the DRSP 3mg/EE 20 µg group were calculated based on incomplete data due to the cut-off date)||Percentage of participants|||Number
739943|NCT00461305|Secondary|Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 13|Non-heavy bleeding was defined as those other than heavy bleeding (i.e. spotting, light, or normal bleeding).|Up to Cycle 13 (364 days) with 28 days per cycle|FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)||Percentage of participants|||Number
740020|NCT00461708|Secondary|OS At 6 Months|OS was defined as the time, in months, from the date of enrollment to the date of death due to any cause. Participants whose last recorded status was not death were censored. OS was estimated using Kaplan-Meier methodology.|Enrollment through Cycle 6 (4-week cycles), up to 6 months.|ITT population; only participants who died were included in the analysis.||months||95% Confidence Interval|Median
739944|NCT00461305|Secondary|Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 6|Non-heavy bleeding was defined as those other than heavy bleeding (i.e. spotting, light, or normal bleeding).|Up to Cycle 6 (168 days) with 28 days per cycle|FAS (Participants with data at Cycle 6, values for Cycle 1 to Cycle 6 (Reference period 1 and Reference period 2) in the DRSP 3mg/EE 20 µg group were calculated based on incomplete data due to the cut-off date)||Percentage of participants|||Number
739945|NCT00461305|Secondary|Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 13|Withdrawal bleedings were defined as bleedings while a participant takes placebo tablets.|Up to Cycle 13 (364 days) with 28 days per cycle|FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)||participants|||Number
739946|NCT00461305|Secondary|Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 6|Withdrawal bleedings were defined as bleedings while a participant takes placebo tablets.|Up to Cycle 6 (168 days) with 28 days per cycle|FAS (Participants with data at Cycle 6, values for Cycle 1 to Cycle 6 (Reference period 1 and Reference period 2) in the DRSP 3mg/EE 20 µg group were calculated based on incomplete data due to the cut-off date)||participants|||Number
739947|NCT00461305|Secondary|Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 13|Intracyclic bleedings were defined as bleedings while a participant takes active tablets.|Up to Cycle 13 (364 days) with 28 days per cycle|FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)||participants|||Number
739948|NCT00461305|Secondary|Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 6|Intracyclic bleedings were defined as bleedings while a participant takes active tablets.|Up to Cycle 6 (168 days) with 28 days per cycle|FAS (Participants with data at Cycle 6, values for Cycle 1 to Cycle 6 (Reference period 1 and Reference period 2) in the DRSP 3mg/EE 20 µg group were calculated based on incomplete data due to the cut-off date)||participants|||Number
739949|NCT00461305|Secondary|Number of Any Bleeding Days From Cycle 1 to Cycle 13|Vaginal bleeding was rated as none, spotting, light, normal, or heavy based on the participant's experience. A reference period is about 3 cycles (90 days): reference period 1 is from Cycle 1 to Cycle 4 (the 1st 90 days), reference period 2 is from Cycle 4 to Cycle 6 (the 2nd 90 days), reference period 3 is from Cycle 7 to Cycle 9 (the 3rd 90 days), reference period 4 is from Cycle 10 to Cycle 12 (the 4th 90 days).|Up to Cycle 13 (364 days) with 28 days per cycle|FAS (Participants with the defined data, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)||days||Full Range|Mean
739950|NCT00461305|Secondary|Number of Any Bleeding Days From Cycle 1 to Cycle 6|Vaginal bleeding was rated as none, spotting, light, normal, or heavy based on the participant's experience. A reference period is about 3 cycles (90 days): reference period 1 is from Cycle 1 to Cycle 3 (the 1st 90 days), reference period 2 is from Cycle 4 to Cycle 6 (the 2nd 90 days).|Up to Cycle 6 (168 days) with 28 days per cycle|FAS (Participants with the defined data, values for Cycle 1 to Cycle 6 (Reference period 1 and Reference period 2) in the DRSP 3mg/EE 20 µg group were calculated based on incomplete data due to the cut-off date)||days||Full Range|Mean
739951|NCT00461305|Secondary|Number of Any Bleeding Episodes From Cycle 1 to Cycle 13|Vaginal bleeding was rated as none, spotting, light, normal, or heavy based on the participant's experience. A reference period is about 3 cycles (90 days): reference period 1 is from Cycle 1 to Cycle 3 (the 1st 90 days), reference period 2 is from Cycle 4 to Cycle 6 (the 2nd 90 days), reference period 3 is from Cycle 7 to Cycle 9 (the 3rd 90 days), reference period 4 is from Cycle 10 to Cycle 12 (the 4th 90 days).|Up to Cycle 13 (364 days) with 28 days per cycle|FAS (Participants with the defined data, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)||number of episodes||Full Range|Mean
739952|NCT00461305|Secondary|Number of Any Bleeding Episodes From Cycle 1 to Cycle 6|Vaginal bleeding was rated as none, spotting, light, normal, or heavy based on the participant's experience. A reference period is about 3 cycles (90 days): reference period 1 is from Cycle 1 to Cycle 3 (the 1st 90 days), reference period 2 is from Cycle 4 to Cycle 6 (the 2nd 90 days).|Up to Cycle 6 (168 days) with 28 days per cycle|FAS (Participants with the defined data, values for Cycle 1 to Cycle 6 (Reference period 1 and Reference period 2) in the DRSP 3mg/EE 20 µg group were calculated based on incomplete data due to the cut-off date)||number of episodes||Full Range|Mean
739953|NCT00461305|Secondary|Change in Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation From Baseline to Cycle 13|VAS is an unmarked scale on a line 100 mm in length, indicating from 0 mm (no pain) to 100 mm (worst pain a participant has ever experienced).|From baseline up to Cycle 13 (364 days) with 28 days per cycle|FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)||scores on a scale||Full Range|Mean
739954|NCT00461305|Secondary|Change in Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation From Baseline to Cycle 6|VAS is an unmarked scale on a line 100 mm in length, indicating from 0 mm (no pain) to 100 mm (worst pain a participant has ever experienced).|From baseline up to Cycle 6 (168 days) with 28 days per cycle|FAS (Participants with data at Cycle 6)||scores on a scale||Full Range|Mean
739955|NCT00461305|Secondary|Change in Visual Analogue Scale (VAS) for Dysmenorrhea at Times Other Than During Menstruation From Baseline to Cycle 13|VAS is an unmarked scale on a line 100 mm in length, indicating from 0 mm (no pain) to 100 mm (worst pain a participant has ever experienced).|From baseline up to Cycle 13 (364 days) with 28 days per cycle|FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)||scores on a scale||Full Range|Mean
739956|NCT00461305|Secondary|Change in Visual Analogue Scale (VAS) for Dysmenorrhea at Times Other Than During Menstruation From Baseline to Cycle 6|VAS is an unmarked scale on a line 100 mm in length, indicating from 0 mm (no pain) to 100 mm (worst pain a participant has ever experienced).|From baseline up to Cycle 6 (168 days) with 28 days per cycle|FAS (Participants with data at Cycle 6)||scores on a scale||Full Range|Mean
739957|NCT00461305|Secondary|Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 13|Total pelvic pain score was defined as sum of 2 sub-scores: severity of dysmenorrhea and use of analgesics. Higher score means it is more severe. 0=None, 6=Severest.|Up to Cycle 13 (364 days) with 28 days per cycle|FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)||participants|||Number
740021|NCT00461708|Secondary|Number of Participants Who Died at 6 Months||Enrollment through Cycle 6 (4-week cycles), up to 6 months.|ITT population||participants|||Number
739959|NCT00461305|Secondary|Distribution of Severity of Nausea or Vomiting During Menstruation at Cycle 13|Severity of nausea or vomiting during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).|Up to Cycle 13 (364 days) with 28 days per cycle|FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)||participants|||Number
739960|NCT00461305|Secondary|Distribution of Severity of Nausea or Vomiting During Menstruation at Cycle 6|Severity of nausea or vomiting during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).|Up to Cycle 6 (168 days) with 28 days per cycle|FAS (Participants with data at Cycle 6)||participants|||Number
739961|NCT00461305|Secondary|Distribution of Severity of Headache During Menstruation at Cycle 13|Severity of headache during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).|Up to Cycle 13 (364 days) with 28 days per cycle|FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)||participants|||Number
739962|NCT00461305|Secondary|Distribution of Severity of Headache During Menstruation at Cycle 6|Severity of headache during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).|Up to Cycle 6 (168 days) with 28 days per cycle|FAS (Participants with data at Cycle 6)||participants|||Number
739963|NCT00461305|Secondary|Distribution of Severity of Lumbago During Menstruation at Cycle 13|Severity of lumbago during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).|Up to Cycle 13 (364 days) with 28 days per cycle|FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)||participants|||Number
739964|NCT00461305|Secondary|Distribution of Severity of Lumbago During Menstruation at Cycle 6|Severity of lumbago during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).|Up to Cycle 6 (168 days) with 28 days per cycle|FAS (Participants with data at Cycle 6)||participants|||Number
739965|NCT00461305|Secondary|Distribution of Severity of Lower Abdominal Pain During Menstruation at Cycle 13|Severity of lower abdominal pain during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).|Up to Cycle 13 (364 days) with 28 days per cycle|FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)||participants|||Number
739966|NCT00461305|Secondary|Distribution of Severity of Lower Abdominal Pain During Menstruation at Cycle 6|Severity of lower abdominal pain during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).|Up to Cycle 6 (168 days) with 28 days per cycle|FAS (Participants with data at Cycle 6)||participants|||Number
739967|NCT00461305|Secondary|Distribution of Total Dysmenorrhea Score at Cycle 13|Total dysmenorrhea score was defined as sum of 2 sub-scores: severity of dysmenorrhea and use of analgesics. Higher score means it is more severe. 0=None, 6=Severest.|Up to Cycle 13 (364 days) with 28 days per cycle|FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)||participants|||Number
739968|NCT00461305|Secondary|Distribution of Total Dysmenorrhea Score at Cycle 6|Total dysmenorrhea score was defined as sum of 2 sub-scores: severity of dysmenorrhea and use of analgesics. Higher score means it is more severe. 0=None, 6=Severest.|Up to Cycle 6 (168 days) with 28 days per cycle|FAS (Participants with data at Cycle 6)||participants|||Number
739969|NCT00461305|Secondary|Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 13|Total dysmenorrheal score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Note: used with permission of Nobelpharma Co., Ltd. from the phase 3 clinical study protocol of IKH-01 in dysmenorrhea (associated with endometriosis) (Nobelpharma Co., Ltd.). Changed total dysmenorrheal scores: -6 to -1 mean improvement, 1 to 6 mean worsening, 0 means no change.|From baseline up to Cycle 13 (364 days) with 28 days per cycle|FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)||participants|||Number
739970|NCT00461305|Secondary|Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6|Total dysmenorrheal score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Note: used with permission of Nobelpharma Co., Ltd. from the phase 3 clinical study protocol of IKH-01 in dysmenorrhea (associated with endometriosis) (Nobelpharma Co., Ltd.). Changed total dysmenorrheal scores: -6 to -1 mean improvement, 1 to 6 mean worsening, 0 means no change.|From baseline up to Cycle 6 (168 days) with 28 days per cycle|FAS (Participants with data at Cycle 6)||participants|||Number
739971|NCT00461305|Primary|Number of Participants With Intracyclic Bleeding at Cycle 6|Intracyclic bleedings were defined as bleedings while a participant takes active tablets.|Up to Cycle 6 (168 days) with 28 days per cycle|FAS (Participants with data at Cycle 6)||participants|||Number
739972|NCT00461331|Secondary|Oxidative Stress Marker 48, 72 and 96 Hours After Keeping the Same Pump Infusion Line in Place|Free 15-F2t isoprostane was measured between days 3 and 5 after the keeping the same pump infusion line in place. It is a marker of oxidative stress due to hyperglycemia that was being compared between the two test periods.|Between 48, 72 and 96 hours after the last pump infusion line change|||pg/ml||Standard Deviation|Mean
739973|NCT00461331|Secondary|Daily Serum Glycomark Levels 48 to 100 Hours After Keeping the Same Pump Infusion Line in Place|Daily serum glycomark levels between day 3 and day 5 after the pump infusion line change. These levels were measured for both the test periods.|48 to 100 hours after keeping the same pump infusion line in place|||µg/ml||Standard Deviation|Mean
739974|NCT00461331|Primary|Number of Participants With Glycemic Control (Glucose Levels Between 180-300 mg/dL) 24 to 100 Hours After Line Change|For each test period, we measured the duration of time that the same pump infusion line could be kept in place without losing glycemic control. Loss of glycemic control was defined as capillary blood glucose level >300 mg/dL.|24 to 100 hours after last pump infusion line change|The analysis was per protocol, intention to treat. Post-study, glucose readings were grouped according to insulin type and patients ability to maintain Glycemic control(maintaing a glucose level between 180 to 300 mg/dL 24 to 100 hrs after last pump infusion line change)was analyzed for that particular insulin.||Participants|||Number
739975|NCT00461500|Secondary|Change From Baseline in Overall Asthma Quality of Life Questionnaire (AQLQ) Score at Week 12|7-point scale where 1=total impairment and 7=no impairment. Questions contain 32 items in four domains. Domains include Activity Limitation (11 items), Symptoms (12 items), Emotional Function (5 items), and Environmental Stimuli (4 items). 32 items produce one overall quality of life score. The 7 points scoring are different and depend on the item : they are the translation in French of the original questionnaire from Juniper. Possible AQLQ scores range from 1 to 7 (the mean of all the questions).|Baseline, Week 12|Intent-to-Treat population.||Score on a scale||Standard Deviation|Mean
739976|NCT00461500|Secondary|ACT Score in Classes at Week 12|Score is ranged from 5 (poor control) to 25 (complete control).|Week 12|Intent-to-Treat population.||Particpants|||Number
739977|NCT00461500|Secondary|Change From Baseline in Asthma Control Test (ACT) Score at Week 12|5 question test with various responses rating frequency of asthma events over 4-week period. Questions include occurrence of asthma affecting work/school; causing shortness of breath; symptoms (wheezing, coughing, shortness of breath, chest tightness, pain) wake you up at night; causing need for rescue medication; asthma control. Scale: 1=all of time, 2=most of time, 3=some of the time, 4=a little of the time, 5=none of the time. Possible ACT scores range from 5 to 25.|Baseline, Week 12|Intent-to-Treat population.||Score on a scale||Standard Deviation|Mean
739978|NCT00461500|Secondary|Number of Participants Who Achieved Total-controlled Asthma During Weeks 5-12|"Totally-controlled asthma is defined as no daily symptoms, no night-time awakenings, no exacerbations, no rescue medication, no emergency visits, no treatment related adverse events resulting in change in asthma therapy, >=80% predicted PEF. The number of subjects who achieved total-controlled asthma at any time during Week 5-12 of the study period will be summarized by treatment groups. The difference between treatment groups will be assessed using logistic regression."|Weeks 5 - 12|Intent-to-Treat population.||Participants|||Number
739979|NCT00461500|Secondary|Median Number of Weeks to First Achieve Well-Controlled Asthma During Weeks 5-12|"Well-controlled asthma is defined as 2 or more of the following: symptoms on no more than 2 days with symptom score of >1; no more than 2 days of rescue meds (maximum of 4 per week); >=80% predicted morning PEF. And no night time awakenings, exacerbations, emergency room visits, and treatment related adverse effects requiring a change to therapy. The median number of weeks to first achieve well-controlled asthma during Week 5-12 of the study period will be summarized by treatment groups. The difference between treatment groups will be assessed using logistic regression."|Weeks 5 - 12|Intent-to-Treat population.||Weeks||Full Range|Median
739980|NCT00461500|Secondary|Number of Participants Who Achieved Well-Controlled Asthma During Weeks 5-12|"Well-controlled asthma is defined as 2 or more of the following: symptoms on no more than 2 days with symptom score of >1; no more than 2 days of rescue meds (maximum of 4 per week); >=80% predicted morning PEF. And no night time awakenings, exacerbations, emergency room visits, and treatment related adverse effects requiring a change to therapy. The number of participants who achieved well-controlled asthma at any time during Week 5-12 of the study period will be summarized by treatment groups. The difference between treatment groups will be assessed using logistic regression."|Weeks 5 -12|Intent-to-Treat population.||Participants|||Number
739981|NCT00461500|Secondary|Number of Participants With at Least One Exacerbation During 12-Week Treatment Period|Subjects will record exacerbations (defined as temporary PEF decrease, increase in salbutamol use) in a Daily Record Card (DRC). The number of events are categorized as those that showed a deterioration in asthma requiring administration of oral corticosteroids and/or a deterioration in asthma requiring emergency room visit and/or hospitalization (hosp.).|12-Week Treatment Period (Week 1 through Week 12)|Intent-to-Treat population.||Participants|||Number
739982|NCT00461500|Secondary|Change From Baseline (BL) in Pre-dose FEF 25-75% (Forced Expiratory Flow) Through Week 12 (Using Last Observation Carried Forward [LOCF] Approach)|Forced Expiratory Flow 25-75% (measured by a spirometer) is the average flow (or speed) of air coming out of the lung during the middle portion of the expiration. Age, height, and gender is used to determine what is normal. Change from BL could have been measured at any time during the study (up to Week 12), using the LOCF (for each individual, missing values are replaced by the last observed value of that variable). Change from BL is measured as percentage of predicted value, with height, gender, age, and race as variables (percentage of predicted value at endpoint minus value at BL).|Baseline through Week 12|Intent-to-Treat population.||Percentage of predicted value||Standard Deviation|Mean
739983|NCT00461500|Secondary|Change From Baseline in Pre-dose Forced Expiratory Vital Capacity (FVC) Through Week 12 (Using Last Observation Carried Forward [LOCF] Approach)|FVC is the total amount of air that can forcibly be blown out after full inspiration, measured in liters. A spirometer is the device used to measure FVC. Age, height and gender is used to determine what is normal. Change from baseline could have been measured at any time during the study (up to Week 12), using the LOCF. In the LOCF approach, for each individual, missing values are replaced by the last observed value of that variable.|Baseline through Week 12|Intent-to-Treat||Liters||Standard Deviation|Mean
739984|NCT00461500|Secondary|Change From Baseline in FEV1 Reversibility Through Week 12 (Using Last Observation Carried Forward [LOCF] Approach)|Reversibility is calculated as the percentage improvement of FEV1 from baseline. Change from baseline could have been measured at any time during the study (up to Week 12), using the LOCF. In the LOCF approach, for each individual, missing values are replaced by the last observed value of that variable. Percent reversibility of FEV1 was calculated as follows: (Post-bronchodilator FEV1 – pre-bronchodilator FEV1)/pre-bronchodilator FEV1 x 100. A negative difference indicates less reversibility.|Baseline through Week 12|Intent-to-Treat population.||Percent change||Standard Deviation|Mean
740176|NCT00462423|Secondary|Overall Survival (OS)|The duration of overall survival was defined as the number of months between the start date of protocol treatment and the date of death (irrespective of cause), and was right-censored at the date of last contact for patients who were alive as of the data cutoff.|April 2007 through December 2010|||months||95% Confidence Interval|Median
739985|NCT00461500|Secondary|Change From Baseline in Pre-dose (Percent Predicted) FEV1 Through Week 12 (Using Last Observation Carried Forward [LOCF] Approach)|Percent predicted is based on tables of normal values that use variables such as age, gender, and weight as a method of standardization. Spirometry results are expressed as a percentage, and are generally considered abnormal if less than 80 percent of the normal predicted value. Change from baseline could have been measured at any time during the study (up to Week 12), using the LOCF. In the LOCF approach, for each individual, missing values are replaced by the last observed value of that variable.|Baseline through Week 12|Intent-to-Treat population.||Percentage predicted of FEV1||Standard Deviation|Mean
739986|NCT00461500|Secondary|Change From Baseline in Pre-dose FEV1 (Forced Expiratory Volume in One Second) Through Week 12 (Using Last Observation Carried Forward [LOCF] Approach)|FEV1 is the amount of air (in liters) you can blow out within one second. A spirometer is the device used to measure FEV1. With normal lungs and airways you can normally blow out most of the air from your lungs within one second. Age, height and gender is used to determine what is normal. Change from baseline could have been measured at any time during the study (up to Week 12), using the LOCF. In the LOCF approach, for each individual, missing values are replaced by the last observed value of that variable.|Baseline through Week 12|Intent-to-Treat population.||Liters||Standard Deviation|Mean
739987|NCT00461500|Primary|Change From Baseline in Mean Morning Peak Expiratory Flow (PEF) Over Weeks 5-12|Mini Wright Peak Flow Meter used to allow patients to monitor their asthma - Peak Flow (or PEF - peak expiratory flow) is a measurement of how fast you can blow out. When someone is well, their PEF is higher - when the airways are narrow (as in asthma), PEF is lower. Readings based on age, height and gender.|Baseline, Weeks 5-12|Intent-to-Treat population are all randomized patients having received one study drug dose and had at least one complete efficacy assessment.||Liters per minute (L/min)||Standard Deviation|Mean
739988|NCT00461513|Secondary|Hospitalization and Mortality, Depressive Symptoms, Patients' Self-efficacy in Management of CHF, Adherence to Prescribed Medications, Patient Satisfaction, Proportion of Patients With Guideline-concordant Care, Cost-effectiveness of the Intervention.||12 months||||||
739989|NCT00461513|Primary|Change in Chronic Heart Failure Health Status Between Baseline and 12 Months.|The primary outcome was average change in the Kansas City Cardiomyopathy Questionnaire Overall Summary Score. This is reported for each group (Intervention and Usual Care). The average for each group and standard deviation are reported. A positive score change represents an improvment in overall patient health status for the group of patients with congestive heart failure. A negative score change represents a worsening in overall patient health status for the group of patients with congestive heart failure.|12 months|||units on a scale||Standard Deviation|Mean
739998|NCT00461630|Secondary|Mortality|All-cause mortality|During scheduled treatment period (median duration 3.9 years)|||participants|||Number
739999|NCT00461630|Secondary|Coronary or Non-coronary Revascularisation||During scheduled treatment period (median duration 3.9 years)|||participants|||Number
740000|NCT00461630|Secondary|Stroke|Fatal or non-fatal|During scheduled treatment period (median duration 3.9 years)|||participants|||Number
740003|NCT00461682|Secondary|Average Daily Pain Scores at Baseline (Pre-dose), 1, 2, 3, 4, 5 and 6h Post-dose for Each Treatment Period|"Individual pain scores were collected at screening and pre and post dose during the anorectal physiological assessments. Average daily pain scores as captured in participants' diary cards were summarized descriptively and analyzed. The 11 point pain intensity numerical rating scale ranges from 0 to 10, where 0 represents “No pain and 10 represents “Worst pain imaginable”. This was used for the subjective assessment of the pain over period. No results were reported since the study objectives were not met due to the early study termination and withdrawal of participant."|At Baseline (pre-dose) and each hour post-dose of each treatment period||||||
740004|NCT00461682|Secondary|Symptom Scoring and Quality of Life Assessments Over Period|Different scales used in this study included HAD, BDI, SF36, Bristol Stool Scoring, IBS QOL and SSS that were used to rate different scores on respective scales. Untreated pain leads to a decrease in daily function capability, social stresses, loss of work, an overall poor quality of life and a burden on healthcare resources. No results were reported since the study objectives were not met due to the early study termination and withdrawal of participant.|Approximately up to 3 months||||||
740005|NCT00461682|Secondary|Irritable Bowel Syndrome Symptom Severity Score (IBS SSS) Calculated Over Approximately 10 Days Pre- and Post-dose|Participants were rated on a scale based on following parameters - Onset associated with change in the frequency and change in the appearance of stools, abnormal stool frequency (>3/day or < 3/week); abnormal stool form (lumpy/hard or loose/watery stool), abnormal stool passage (straining, urgency, or feeling of incomplete evacuation); passage of mucus, and bloating were analyzed over period. No results were reported since the study objectives were not met due to the early study termination and withdrawal of participant.|10 days pre-dose and post-dose of each treatment period||||||
740006|NCT00461682|Secondary|Number of Defecations Over 24h and Over 1 Week Following a Dose of SB-705498 (Monitored Using Bristol Stool Scoring Diary Kept 1 Week Pre- and 1 Week Post-dose)|Onset associated with change in the frequency and change in the appearance of stools, abnormal stool frequency (>3/day or < 3/week); abnormal stool form (lumpy/hard or loose/watery stool), abnormal stool passage (straining, urgency, or feeling of incomplete evacuation); passage of mucus, and bloating were analyzed over period. No results were reported since the study objectives were not met due to the early study termination and withdrawal of participant.|7 days pre-dose and 7 days post-dose of each treatment period||||||
740007|NCT00461682|Secondary|Contact Heat-evoked Potentials (CHEPs) – Optional, Assessed Pre-dose and 6h Post-dose of Each Treatment Period|For heat pain threshold measurement, temperature of the thermode was gradually increased from the baseline (32°C) at a rate of 1°C/s. The ramp was stopped and the temperature of the thermode was returned to the Baseline. This was repeated three times. The threshold temperatures and the average value were recorded by the computer. If the thermode temperature reached 50°C without the participant responding, the ramp was stopped and the temperature was returned to baseline automatically to prevent skin injury. This test was performed within two minutes. The respective cut-off temperature is then recorded for that trial. No results were reported since the study objectives were not met due to the early study termination and withdrawal of participant.|Baseline (pre-dose) and 6h post-dose of each treatment period||||||
740008|NCT00461682|Secondary|Somatic Heat Pain Thresholds (Hand and Foot) Assessed Pre-dose and 6h Post-dose of Each Treatment Period|Evoked potentials were to be recorded from midline electrodes by placing a ground electrode on temporal lobe region. A low cut off filter with a time constant of 1.06103 and a frequency of 0.15 hertz (Hz) and a high cut off filter of 100Hz was to be applied. The impedance from all electrodes was maintained below 5 ohms (Ω) and the electroencephalogram (EEG) was recorded, digitized at a sampling rate of 500 Hz. Responses from ten stimuli were to be recorded from each participant with the thermode placed over foot and one hand (non-dominant side). The thermode heating rate was set at 70 degree Celsius per second (°C/s) and the cooling rate at 40°C/s. The baseline temperature was 32 °C, destination temperature 51 °C, and stimulus interval approximately of 7 seconds. The participants were allowed to withdraw any time. No results were reported since the study objectives were not met due to the early study termination and withdrawal of participant.|Baseline (pre-dose) and upto 0-6h post-dose for each treatment period||||||
740009|NCT00461682|Secondary|Pain Intensity Difference (SPID6), as Derived From Pain Intensity (NRS) Difference From Baseline (Pre-dose on Day 1) by Single Measurement Recorded Over 0-6h Post-dose of Each Treatment Period|"Change from Baseline (pre-dose0 is the value at indicated time point minus the Baseline value. Average daily pain scores as captured in participant diary cards were planned to be summarized descriptively and planned to be analyzed. The 11 point pain intensity numerical rating scale ranging from 0 to 10, where 0 represents “No pain and 10 represents “Worst pain imaginable” was planned to be used for the subjective assessment of the pain. No results were reported since the study objectives were not met due to the early study termination and withdrawal of participant."|Baseline (pre-dose) and up to 0-6 h post-dose of each treatment period||||||
740010|NCT00461682|Secondary|Peak Pain Intensity Difference (PPID6), as Derived From Maximum Pain Intensity (NRS) Difference From Baseline (Pre-dose on Day 1) by Single Measurement Recorded Over 0-6h of Each Treatment Period|"No results were reported since the study objectives were not met due to the early study termination and withdrawal of participant. Change from Baseline (pre-dose) is the value at indicated time-point minus the Baseline value. Average daily pain scores as captured in participant diary cards were planned to be summarized descriptively and planned to be analyzed. The 11 point pain intensity numerical rating scale ranging from 0 to 10, where 0 represents “No pain and 10 represents “Worst pain imaginable” was planned to be used for the subjective assessment of the pain."|Baseline (pre-dose) and up to 0-6 h of each treatment period||||||
740022|NCT00461708|Primary|Overall Survival (OS) During the Study|OS was defined as the time, in months, from the date of enrollment to the date of death due to any cause. Participants whose last recorded status was not death were censored. OS was estimated using Kaplan-Meier methodology.|Enrollment through Cycle 24 (4-week cycles), up to 24 months.|ITT population; only participants who died were included in the analysis.||months||95% Confidence Interval|Median
740023|NCT00461708|Primary|Number of Participants Who Died During the Study||Enrollment through Cycle 24 (4-week cycles), up to 24 months.|ITT population||participants|||Number
740024|NCT00461734|Secondary|6 Minute Hall-Walk Distance (Per Protocol Cohort)||At 2-year follow-up|Per Protocol Cohort with data available||meters||Inter-Quartile Range|Median
740025|NCT00461734|Secondary|6 Minute Hall-Walk Distance (Intent to Treat Cohort)||At 2-year follow-up|Intent to Treat Cohort with data available||meters||Inter-Quartile Range|Median
740011|NCT00461682|Secondary|Rectal Sensory Thresholds to Thermal Stimulation (Contact Heat Device, Values Reported as in Study) at Pre-dose and 6h Post-dose of Each Treatment Period|Visceral hypersensitivity is defined as reduced pain and discomfort threshold to rectal stimuli. Rectal hypersensitivity was correlated with the degree of rectal hypersensitivity (up-regulation of TRPV-1 receptors) as measured by rectal thermal stimulation. Ongoing rectal pain intensity scale is 11-point numeric rating scale, where 0=Unnoticeable/No Pain, 10=Unbearable/Worst Pain. An average of daily scores over 1 week pre-dose and 1 week post-dose was recorded. Single measurements pre-dose and at hourly intervals within 6 hours post-dose were also recorded. Participants were planned to stay in the hospital for 6h post-dose and were planned to be discharged when physician was satisfied with their medical condition. No results were reported since the study objectives were not met due to the early study termination and withdrawal of participant. Participants assessed the cough severity and urge to cough using VAS immediately prior to capsaicin challenge.|Baseline (pre-dose) and 6h post-dose of each treatment period||||||
740012|NCT00461682|Secondary|Visual Analogue Scores for Rectal Distensions for Gas, Urgency to Defecate and Discomfort at Pre-dose and 6 h Post-dose of Each Treatment Period|"The VAS scores for assessment of rectal sensation for pain, gas, urgency and discomfort were analyzed separately. Participants assessed the cough severity and urge to cough using VAS immediately prior to capsaicin challenge. No results were reported since the study objectives were not met due to the early study termination and withdrawal of participant. Average of Day -1 and pre-dose was planned as Baseline for VAs assessment. The VAS score was planned to be analyzed on Day-1, Day 1, 2 hours, and 24 hours. Average daily pain scores as captured in participant diary cards were planned to be summarized descriptively and planned to be analyzed. The 11 point pain intensity numerical rating scale ranging from 0 to 10, where 0 represents “No pain and 10 represents “Worst pain imaginable” was planned to be used for the subjective assessment of the pain. No results were reported since the study objectives were not met due to the early study termination and withdrawal of participant."|Baseline (pre-dose) and up to 6 h post-dose of each treatment period||||||
740013|NCT00461682|Primary|Visual Analogue Scale (VAS) Pain Score to Rectal Distensions at Pre-dose and up to 6 Hours (h) Post-dose of Each Treatment Period|"This analysis was performed at 12, 24, 36 and 48 millimeters of mercury (mmHg) which was above the baseline operating pressure threshold. Participants assessed the cough severity and urge to cough using VAS immediately prior to capsaicin challenge. No results were reported since the study objectives were not met due to the early study termination and withdrawal of participant. Average of Day -1 and pre-dose was planned as Baseline for VAs assessment. The VAS score was planned to be analyzed on Day-1, Day 1, 2 hours, and 24 hours. Average daily pain scores as captured in participant diary cards were planned to be summarized descriptively and planned to be analyzed. The 11 point pain intensity numerical rating scale ranging from 0 to 10, where 0 represents “No pain and 10 represents “Worst pain imaginable” was planned to be used for the subjective assessment of the pain."|Baseline (Pre-dose) and up to 6 hours post-dose of each treatment period||||||
740014|NCT00461708|Secondary|Percentage of Participants With Disease Control According to RECIST|Disease control was defined as BOR of CR, PR, or stable disease (SD). As per RECIST V 1.0: for TLs, a CR was defined as the disappearance of all TLs; and a PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD. For NTLs, a CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD was defined as the persistence of one or more NTLs and/or maintenance of tumor marker level above the normal limits. Participants for whom no assessment of response was available and who had finalized the study due to disease progression or tumor-related death, disease progression was considered the BOR.|Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months.|ITT population||percentage of participants|||Number
740015|NCT00461708|Secondary|Percentage of Participants With Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) According to RECIST|As per RECIST V 1.0: for TLs, a CR was defined as the disappearance of all TLs; and a PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline (BL) SLD. For NTLs, a CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. Participants for whom no assessment of response was available and who had finalized the study due to disease progression or tumor-related death, disease progression was considered the BOR.|Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months.|ITT population||percentage of participants|||Number
740016|NCT00461708|Secondary|PFS|The time, in months, from enrollment to PFS event. Participants whose last recorded status was not progression or death were censored. PFS was estimated using Kaplan-Meier methodology.|Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months|ITT population; only participants with an event (death or disease progression) were included in the analysis.||months||95% Confidence Interval|Median
740017|NCT00461708|Secondary|Number of Participants With Disease Progression or Death|Progression-free survival (PFS) was defined as the time from the date of enrollment to the date of document disease progression or death due to any cause. As per Response Evaluation Criteria in Solid Tumors (RECIST) V 1.0, progressive disease (PD) was defined for target lesions (TLs) as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded since the start of treatment, and for non-target lesions (NTLs) as unequivocal progression of NTLs. Participants whose last recorded status was not PD or death were censored.|Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months.|ITT population||participants|||Number
740018|NCT00461708|Secondary|OS By Rash Grade|OS was defined as the time, in months, from the date of enrollment to the date of death due to any cause. Participants whose last recorded status was not death were censored. OS was estimated using Kaplan-Meier methodology.|Enrollment through Cycle 24 (4-week cycles), up to 24 months.|ITT population; only participants who died were included in the analysis.||months||95% Confidence Interval|Median
740019|NCT00461708|Secondary|Number of Participants Who Died During the Study By Rash Grade||Enrollment through Cycle 24 (4-week cycles), up to 24 months.|ITT population||participants|||Number
740026|NCT00461734|Secondary|Echocardiographic Measures of Left Ventricular Dyssynchrony|No analysis has been done for this section since that variable was not collected during the study.|At 2-year follow-up|No analysis has been done for this section since that variable was not collected during the study|||||
740031|NCT00461734|Secondary|Worsening of Heart Failure|"Worsening of heart failure can be defined as:
Heart failure-related hospitalization requiring intravenous heart failure therapy, or
Emergency department visit for heart failure requiring intravenous heart failure therapy, or
Any other visit in which the patient presents with signs or symptoms consistent with heart failure or heart failure exacerbation or marked decline in ejection fraction <35%, and intravenous heart failure therapy is required or titrate therapy.
CRT-P or CRT-D upgrade."|At 5-year follow-up (study extension)|||episodes|||Number
740032|NCT00461734|Secondary|Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Per Protocol Cohort)||At 5-year follow-up (study extension)|Per Protocol Cohort with data available||minutes per day||Standard Deviation|Mean
740033|NCT00461734|Secondary|Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Intent to Treat Cohort)||At 5-years follow-up (study extension)|Intent to Treat Cohort with data available||minutes per day||Standard Deviation|Mean
740034|NCT00461734|Secondary|Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Per Protocol Cohort)||At 2-year follow-up|Per Protocol Cohort with data available||minutes per day||Standard Deviation|Mean
740035|NCT00461734|Secondary|Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Intent to Treat Cohort)||At 2-year follow-up|Intent to Treat Cohort with data available||minutes per day||Standard Deviation|Mean
740036|NCT00461734|Primary|Change in Left Ventricular Ejection Fraction From Baseline to 2 Years (Per Protocol Cohort).||At 2-year follow-up|Per Protocol Cohort with data available||percentage||Standard Deviation|Mean
740037|NCT00461734|Primary|Change in Left Ventricular Ejection Fraction From Baseline to 2 Years (Intent to Treat Cohort).||At 2-year follow-up|Intent to Treat Cohort with data available||percentage||Standard Deviation|Mean
740038|NCT00461786|Secondary|Overall Survival|Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.|baseline until death from any cause up to 5-year follow-up|||months||Full Range|Median
740039|NCT00461786|Secondary|Progression-Free Survival|Defined as the time from date of first dose to the first observation of disease progression, or death due to any cause.|baseline until documented tumor progression (up to 44 months)|||months||Full Range|Median
740040|NCT00461786|Secondary|Duration of Response|The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.|time of initial response until documented tumor progression (up to 44 months)|||months||Full Range|Median
740041|NCT00461786|Secondary|Number of Participants With Adverse Events by Grade|Adverse events were graded using the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) for defining and grading specific adverse events. A grading (severity) scale is provided for each adverse event term. Grades range from 0 (none) to 5 (death). The worst grade event per cycle is reported.|every 21-day cycle up to 5 year follow-up|||participants|||Number
740042|NCT00461786|Primary|Tumor Response|"Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve (respond), stay the same (stable), or worsen (progression) during treatment. Complete response (CR) = disappearance of all target lesions; Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions; Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions; Stable disease (SD) = small changes that do not meet above criteria."|baseline to measured progressive disease (up to 44 months)|||participants|||Number
740043|NCT00461812|Primary|Efficacy as Assessed my Pulmonary Function Tests||change from baseline to study completion|There is no data available for this outcome measure. The study was prematurely terminated and the PI is no longer with the institution. The information available was obtained from the IRB.|||||
740044|NCT00461851|Secondary|To Define the Proportion of Patients With Advanced or Metastatic Transitional Cell Carcinoma of the Bladder That Achieve a Complete or Partial Response to the Combination Therapy With Sorafenib, Gemcitabine, and Carboplatin.||Upon completion of study||12/2016||||
740045|NCT00461851|Secondary|To Determine the Overall Safety and Tolerability of Combination Therapy With Sorafenib, Gemcitabine and Carboplatin||Upon completion of study||12/2016||||
740046|NCT00461851|Primary|To Evaluate the Time to Disease Progression in Patients With Advanced/Metastatic TCC Treated With the Combination of Sorafenib, Gemcitabine, and Carboplatin.||Upon completion of study|||months||95% Confidence Interval|Median
740047|NCT00461981|Primary|Distribution of Interferon (IFN)-Alpha/Beta Gene Signature Scores Among All Subjects|Distribution of IFN-alpha/beta gene signature scores at 7 to 10 days after Dose 1. IFN alpha/beta gene signature scores were calculated as the average fold change in a panel of 21 type 1 IFN-inducible genes. The distribution of IFN alpha/beta gene signature scores ranged from -4 to 4, with -4 representing the lowest level of activity and 4 representing the highest level of activity. The percentage of subjects by IFN-alpha/beta gene signature score for each treatment group were compared.|Post Dose 1 (28 to 42 days post Dose 1)|||Units on a scale|||Number
740048|NCT00461981|Primary|Median Fold-Rises in the Number of Interferon-gamma Elispots Per 200,000 Peripheral Blood Mononuclear Cells (PBMCs) by T-cell Elispot Assay|Median number of PBMCs secreting interferon-gamma as measured by the number of spot forming cells per 200,000 PBMCs (SPC/2 x 10^5 PBMCs) as measured by the T-cell Elispot assay at 28 to 35 days after Dose 2. The results were summarized for wild-type (wt) influenza-specific response (wt fluorescein [FLU]) after adjusting plate background response at 28 to 35 days after Dose 2|Post Dose 2 (28 to 35 days post Dose 2)|Evaluable subjects for the ELISPOT immunogenicity included those who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV) and had valid pre-Dose 1 and any post-Dose T-cell Elispot results (n=3; n=6)||SPC/2 x 10^5 PBMCs||Full Range|Median
740049|NCT00461981|Primary|Median Fold-Rises in the Number of Interferon-gamma Elispots Per 200,000 Peripheral Blood Mononuclear Cells (PBMCs) by T-cell Elispot Assay Following the First Dose|Median number of PBMCs secreting interferon-gamma as measured by the number of spot forming cells per 200,000 PBMCs (SPC/2 x 10^5 PBMCs) as measured by the T-cell Elispot assay at 28 to 42 days after Dose 1. The results were summarized for wild-type (wt) influenza-specific response (wt fluorescein [FLU]) after adjusting plate background response at 28 to 42 days after Dose 1|Post Dose 1 (28 to 42 days post Dose 1)|Evaluable subjects for the ELISPOT immunogenicity included those who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV) and had valid pre-Dose 1 and post-Dose 1 T-cell Elispot results (n=12; n=15)||SPC/2 x 10^5 PBMCs||Full Range|Median
740050|NCT00461981|Primary|Immunogenicity Response by B-cell IgG and IgA ELISPOT Assay|Counts of antibody secreting cells (ASCs) per 10^6 peripheral blood mononuclear cells (PBMCs) for influenza-specific response (ie, anti-IgG fluorescein [FLU] or anti-IgA FLU) and influenza-specific response after adjusting plate background response (ie, anti-IgG FLU/anti-IgG total or anti-IgA FLU/anti-IgA total) as measured by B-cell ELISPOT assay at 7 to 10 days after Dose 2|Post Dose 2 (7 to 10 days post Dose 2)|Evaluable subjects for the ELISPOT immunogenicity included those who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had baseline data (n=30; n=35), and any protocol-specified post-dose timepoint data for B-cell ELISPOT (n=10; n=9).||Counts of ASCs per 10^6 PBMCs||Full Range|Median
740051|NCT00461981|Primary|Immunogenicity Response by B-cell IgG and IgA ELISPOT Assay|Counts of antibody secreting cells (ASCs) per 10^6 peripheral blood mononuclear cells (PBMCs) for influenza-specific response (ie, anti-IgG fluorescein [FLU] or anti-IgA FLU) and influenza-specific response after adjusting plate background response (ie, anti-IgG FLU/anti-IgG total or anti-IgA FLU/anti-IgA total) as measured by B-cell ELISPOT assay at 7 to 10 days after Dose 1|Post Dose 1 (7 to 10 days post Dose 1)|Evaluable subjects for the ELISPOT immunogenicity included those who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had baseline data (n=30; n=35), and any protocol-specified post-dose timepoint data for B-cell ELISPOT (n=16; n=17).||Counts of ASCs per 10^6 PBMCs||Full Range|Median
740052|NCT00461981|Primary|Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain|The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H3N2 /wt A/Brisbane/10/2007 antigenically mismatched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=7; n=8), and had a baseline HAI titer of 10 or less (n=5; n=5).||Titer||95% Confidence Interval|Geometric Mean
740053|NCT00461981|Primary|Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain|The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H3N2 /wt A/Brisbane/10/2007 antigenically mismatched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=7; n=12), and had a baseline HAI titer of 10 or less (n=3; n=7).||Titer||95% Confidence Interval|Geometric Mean
740054|NCT00461981|Primary|Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain|The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /wt A/Solomon Island/3/06 antigenically mismatched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=7; n=8), and had a baseline HAI titer of 10 or less (n=1; n=2).||Titer||95% Confidence Interval|Geometric Mean
740055|NCT00461981|Primary|Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - B /wt B/Malaysia/2506/04 Influenza Strain|The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the B /wt B/Malaysia/2506/049 antigenically matched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=16; n=16), and had a baseline HAI titer of 10 or less (n=13; n=12).||Titer||95% Confidence Interval|Geometric Mean
740056|NCT00461981|Primary|Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain|The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /wt A/Solomon Island/3/06 antigenically mismatched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=16; n=14), and had a baseline HAI titer of 10 or less (n=1; n=3).||Titer||95% Confidence Interval|Geometric Mean
740057|NCT00461981|Primary|Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - B /wt B/Malaysia/2506/04 Influenza Strain|The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the B /wt B/Malaysia/2506/04 antigenically matched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=30; n=27), and had a baseline HAI titer of 10 or less (n=22; n=21).||Titer||95% Confidence Interval|Geometric Mean
740058|NCT00461981|Primary|Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain|The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H3N2 /wt A/Wisconsin/67/05 antigenically matched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=17; n=22), and had a baseline HAI titer of 10 or less (n=12; n=16).||Titer||95% Confidence Interval|Geometric Mean
740059|NCT00461981|Primary|Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain|The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H3N2 /wt A/Wisconsin/67/05 antigenically matched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=35; n=31), and had a baseline HAI titer of 10 or less (n=27; n=21).||Titer||95% Confidence Interval|Geometric Mean
740060|NCT00461981|Primary|Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain|The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /ca A/New Caledonia/20/999 antigenically matched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=20; n=22), and had a baseline HAI titer of 10 or less (n=12; n=13).||Titer||95% Confidence Interval|Geometric Mean
740061|NCT00461981|Primary|Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain|The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /ca A/New Caledonia/20/99 antigenically matched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=40; n=35), and had a baseline HAI titer of 10 or less (n=20; n=20).||Titer||95% Confidence Interval|Geometric Mean
740062|NCT00461981|Primary|Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain|The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /wt A/New Caledonia/20/99 antigenically matched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=21; n=19), and had a baseline HAI titer of 10 or less (n=12; n=12).||Titer||95% Confidence Interval|Geometric Mean
740063|NCT00461981|Primary|Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain|The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /wt A/New Caledonia/20/99 antigenically matched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=40; n=34), and had a baseline HAI titer of 10 or less (n=19; n=18).||Titer||95% Confidence Interval|Geometric Mean
740064|NCT00461981|Primary|Percentage of Subjects With Antigenically Mismatched Strain-specific Microneutralization Seroconversion Following the Second Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H3N2 /wt A/Brisbane/10/2007 antigenically mismatched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=7; n=8), and had a baseline HAI titer of 10 or less (n=5; n=5).||Percentage of Participants|||Number
740065|NCT00461981|Primary|Percentage of Subjects With Antigenically Mismatched Strain-specific Microneutralization Seroconversion Following the First Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H3N2 /wt A/Brisbane/10/2007 antigenically mismatched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=7; n=12), and had a baseline HAI titer of 10 or less (n=3; n=7).||Percentage of Participants|||Number
740066|NCT00461981|Primary|Percentage of Subjects With Antigenically Mismatched Strain-specific Microneutralization Seroconversion Following the Second Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /wt A/Solomon Island/3/06 antigenically mismatched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=7; n=8), and had a baseline HAI titer of 10 or less (n=1; n=2).||Percentage of Participants|||Number
740116|NCT00462280|Secondary|At Least 1 Study-related Adverse Event Reported During the Study|All participants will be evaluable for toxicity from the time of their informed consent. Incidence of adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0.|Baseline up to 26 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm."||participants|||Number
740067|NCT00461981|Primary|Percentage of Subjects With Antigenically Mismatched Strain-specific Microneutralization Seroconversion Following the First Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /wt A/Solomon Island/3/06 antigenically mismatched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=16; n=14), and had a baseline HAI titer of 10 or less (n=1; n=3).||Percentage of Participants|||Number
740068|NCT00461981|Primary|Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the Second Dose - B /wt B/Malaysia/2506/04 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the B /wt B/Malaysia/2506/049 antigenically matched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=16; n=16), and had a baseline HAI titer of 10 or less (n=13; n=12).||Percentage of Participants|||Number
740069|NCT00461981|Primary|Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the First Dose - B /wt B/Malaysia/2506/04 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the B /wt B/Malaysia/2506/04 antigenically matched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=30; n=27), and had a baseline HAI titer of 10 or less (n=22; n=21).||Percentage of Participants|||Number
740070|NCT00461981|Primary|Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the Second Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H3N2 /wt A/Wisconsin/67/05 antigenically matched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=17; n=22), and had a baseline HAI titer of 10 or less (n=12; n=16).||Percentage of Participants|||Number
740071|NCT00461981|Primary|Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the First Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H3N2 /wt A/Wisconsin/67/05 antigenically matched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=35; n=31), and had a baseline HAI titer of 10 or less (n=27; n=21).||Percentage of Participants|||Number
740072|NCT00461981|Primary|Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the Second Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /ca A/New Caledonia/20/999 antigenically matched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=20; n=22), and had a baseline HAI titer of 10 or less (n=12; n=13).||Percentage of Participants|||Number
740073|NCT00461981|Primary|Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the First Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /ca A/New Caledonia/20/99 antigenically matched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=40; n=35), and had a baseline HAI titer of 10 or less (n=20; n=20).||Percentage of Participants|||Number
740074|NCT00461981|Primary|Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the Second Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /wt A/New Caledonia/20/99 antigenically matched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=21; n=19), and had a baseline HAI titer of 10 or less (n=12; n=12).||Percentage of Participants|||Number
740117|NCT00462280|Secondary|Change in C-reactive Protein (mg/dL) From Baseline After Treatment||Baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."||mg/dL||95% Confidence Interval|Mean
740177|NCT00462423|Secondary|Progression-free Survival|Median time of progression-free survival from first treatment according to RECIST 1.0|From start of treatment to disease progressin; median duration of follow-up for surviving patients was 41.6 months.|||Months||95% Confidence Interval|Median
740075|NCT00461981|Primary|Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the First Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /wt A/New Caledonia/20/99 antigenically matched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=40; n=34), and had a baseline HAI titer of 10 or less (n=19; n=18).||Percentage of Participants|||Number
740076|NCT00461981|Primary|Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain|The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H3N2 /wt A/Brisbane/10/2007 Influenza Strain antigenically mismatched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=22; n=26), and had a baseline HAI titer of 4 or less (n=19; n=19).||Titer||95% Confidence Interval|Geometric Mean
740077|NCT00461981|Primary|Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain|The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H3N2 /wt A/Brisbane/10/2007 Influenza Strain antigenically mismatched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=43; n=40), and had a baseline HAI titer of 4 or less (n=36; n=31).||Titer||95% Confidence Interval|Geometric Mean
740078|NCT00461981|Primary|Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain|The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /wt A/Solomon Island/3/06 Influenza Strain antigenically mismatched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=22; n=26), and had a baseline HAI titer of 4 or less (n=14; n=21).||Titer||95% Confidence Interval|Geometric Mean
740079|NCT00461981|Primary|Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain|The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /wt A/Solomon Island/3/06 Influenza Strain antigenically mismatched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=43; n=39), and had a baseline HAI titer of 4 or less (n=24; n=29)||Titer||95% Confidence Interval|Geometric Mean
740080|NCT00461981|Primary|Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - B /wt B/Malaysia/2506/04 Influenza Strain|The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the B /wt B/Malaysia/2506/04 Influenza Strain antigenically matched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=23; n=25), and had a baseline HAI titer of 4 or less (n=20; n=20).||Titer||95% Confidence Interval|Geometric Mean
740081|NCT00461981|Primary|Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - B /wt B/Malaysia/2506/04 Influenza Strain|The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the B /wt B/Malaysia/2506/04 Influenza Strain antigenically matched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=44; n=37), and had a baseline HAI titer of 4 or less (n=34; n=31).||Titer||95% Confidence Interval|Geometric Mean
740082|NCT00461981|Primary|Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain|The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H3N2 /wt A/Wisconsin/67/05 Influenza Strain antigenically matched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=22; n=26), and had a baseline HAI titer of 4 or less (n=18; n=18).||Titer||95% Confidence Interval|Geometric Mean
740118|NCT00462280|Secondary|Change in CPK (U/L) From Baseline After Treatment||Baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."||U/L||95% Confidence Interval|Mean
740178|NCT00462423|Primary|Progression-free Survival (PFS) at 4 Months|Progression-free survival at 4 months from first treatment as determined by RECIST 1.0|4 months.|||percentage of patients||95% Confidence Interval|Number
740083|NCT00461981|Primary|Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain|The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H3N2 /wt A/Wisconsin/67/05 Influenza Strain antigenically matched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=43; n=40), and had a baseline HAI titer of 4 or less (n=34; n=30).||Titer||95% Confidence Interval|Geometric Mean
740084|NCT00461981|Primary|Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain|The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /ca A/New Caledonia/20/99 antigenically matched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=21; n=26), and had a baseline HAI titer of 4 or less (n=13; n=19).||Titer||95% Confidence Interval|Geometric Mean
740085|NCT00461981|Primary|Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain|The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /ca A/New Caledonia/20/99 antigenically matched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=42; n=39), and had a baseline HAI titer of 4 or less (n=20; n=26).||Titer||95% Confidence Interval|Geometric Mean
740086|NCT00461981|Primary|Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain|The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2)for the H1N1 /wt A/New Caledonia/20/99 antigenically matched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=23; n=26), and had a baseline HAI titer of 4 or less (n=14; n=19).||Titer||95% Confidence Interval|Geometric Mean
740087|NCT00461981|Primary|Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain|The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /wt A/New Caledonia/20/99 antigenically matched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=44; n=39), and had a baseline HAI titer of 4 or less (n=24; n=27).||Titer||95% Confidence Interval|Geometric Mean
740088|NCT00461981|Primary|Percentage of Subjects With Antigenically Mismatched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the Second Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H3N2 /wt A/Brisbane/10/2007 antigenically mismatched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=22; n=26), and had a baseline HAI titer of 4 or less (n=19; n=19).||Percentage of Participants|||Number
740089|NCT00461981|Primary|Percentage of Subjects With Antigenically Mismatched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the First Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H3N2 /wt A/Brisbane/10/2007 antigenically mismatched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=43; n=40), and had a baseline HAI titer of 4 or less (n=36; n=31).||Percentage of Participants|||Number
740090|NCT00461981|Primary|Percentage of Subjects With Antigenically Mismatched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the Second Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /wt A/Solomon Island/3/06 antigenically mismatched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=22; n=26), and had a baseline HAI titer of 4 or less (n=14; n=21).||Percentage of Participants|||Number
740119|NCT00462280|Secondary|Change in SGOT/ALT (U/L) From Baseline After Treatment||Baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."||U/L||95% Confidence Interval|Mean
740091|NCT00461981|Primary|Percentage of Subjects With Antigenically Mismatched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the First Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /wt A/Solomon Island/3/06 antigenically mismatched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=43; n=39), and had a baseline HAI titer of 4 or less (n=24; n=29).||Percentage of Participants|||Number
740092|NCT00461981|Primary|Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the Second Dose - B /wt B/Malaysia/2506/04 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the B /wt B/Malaysia/2506/04 antigenically matched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=23; n=25), and had a baseline HAI titer of 4 or less (n=20; n=20).||Percentage of Participants|||Number
740093|NCT00461981|Primary|Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the First Dose - B /wt B/Malaysia/2506/04 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the B /wt B/Malaysia/2506/04 antigenically matched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=44; n=37), and had a baseline HAI titer of 4 or less (n=34; n=31).||Percentage of Participants|||Number
740094|NCT00461981|Primary|Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the Second Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H3N2 /wt A/Wisconsin/67/05 antigenically matched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=22; n=26), and had a baseline HAI titer of 4 or less (n=18; n=18).||Percentage of Participants|||Number
740095|NCT00461981|Primary|Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI)Seroconversion Following the First Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H3N2 /wt A/Wisconsin/67/05 antigenically matched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=43; n=40), and had a baseline HAI titer of 4 or less (n=34; n=30).||Percentage of Participants|||Number
740096|NCT00461981|Primary|Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI)Seroconversion Following the Second Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /ca A/New Caledonia/20/99 antigenically matched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=21; n=26), and had a baseline HAI titer of 4 or less (n=13; n=19).||Percentage of Participants|||Number
740097|NCT00461981|Primary|Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI)Seroconversion Following the First Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /ca A/New Caledonia/20/99 antigenically matched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=42; n=39), and had a baseline HAI titer of 4 or less (n=20; n=26).||Percentage of Participants|||Number
740098|NCT00461981|Primary|Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the Second Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /wt A/New Caledonia/20/99 antigenically matched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=23; n=26), and had a baseline HAI titer of 4 or less (n=14; n=19).||Percentage of Participants|||Number
740120|NCT00462280|Secondary|Change in SGOT/AST (U/L) From Baseline After Treatment||Baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."||U/L||95% Confidence Interval|Mean
740099|NCT00461981|Primary|Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI)Seroconversion Following the First Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /wt A/New Caledonia/20/99 antigenically matched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=44; n=39), and had a baseline HAI titer of 4 or less (n=24; n=27).||Percentage of Participants|||Number
740100|NCT00462020|Secondary|Length of Stay, Charges, Adverse Events||1 month||||||
740101|NCT00462020|Primary|Abscess After Appendectomy||1 month|||number of patients|||Number
740102|NCT00462072|Primary|Psoriasis Area and Severity Index (PASI) Delta|The PASI Delta for Ps subjects is a measure used to determine the change in the severity of an individual's disease with a positive delta indicating an improvement in the severity of subject's disease and a negative delta indicating a worsening of a subject's disease. The delta score is used to monitor treatment. The week 10 PASI Delta is determined by calculating the average change between the wk 0 and wk 10 PASI.|Week 10|PASI formula PASI = 0.1 * (erythemahead + indurationhead + desquamationhead) * Area Scorehead + 0.2 * (erythemaarm + indurationarm + desquamationarm) * Area Scorearm + 0.3 * (erythematorso + indurationtorso + desquamationtorso) * Area Scoretorso + 0.4 * (erythemaleg + indurationleg + desquamationleg) * Area Scoreleg||Index Delta||Standard Deviation|Mean
740103|NCT00462072|Primary|Baseline (Wk 10) Psoriasis Area and Severity Index (PASI)|A PASI score for Ps subjects is an outcome measure used in determining the severity of an individual's disease. This score is used to assess disease activity and to make and monitor treatment decisions. The week 10 PASI is an average of the study population's week 10 disease activity score after taking infliximab (remicade) for 10 weeks.|Week 10|PASI formula PASI = 0.1 * (erythemahead + indurationhead + desquamationhead) * Area Scorehead + 0.2 * (erythemaarm + indurationarm + desquamationarm) * Area Scorearm + 0.3 * (erythematorso + indurationtorso + desquamationtorso) * Area Scoretorso + 0.4 * (erythemaleg + indurationleg + desquamationleg) * Area Scoreleg||Index||Standard Deviation|Mean
740104|NCT00462072|Primary|Baseline (Wk 0) Psoriasis Area and Severity Index (PASI)|A PASI score for Ps subjects is an outcome measure used in determining the severity of an individual's disease. This score is used to assess disease activity and to make and monitor treatment decisions. The baseline PASI is an average of the study populations baseline disease activity score prior to the administration of infliximab (remicade). While higher PASI scores indicate more severe psoriasis, it is difficult for subjects or doctors to describe the clinical severity for any specific PASI number.|Baseline (Wk 0)|PASI formula PASI = 0.1 * (erythemahead + indurationhead + desquamationhead) * Area Scorehead + 0.2 * (erythemaarm + indurationarm + desquamationarm) * Area Scorearm + 0.3 * (erythematorso + indurationtorso + desquamationtorso) * Area Scoretorso + 0.4 * (erythemaleg + indurationleg + desquamationleg) * Area Scoreleg||Index||Standard Deviation|Mean
740105|NCT00462072|Primary|Disease Activity Score (DAS28) Delta|The DAS28 Delta for RA and PsA subjects is measure used to determine the change in the severity of an individual's disease with positive delta indicating an improvement in the severity of subject's disease and a negative delta indicating a worsening of a subject's disease. The delta score is used to monitor treatment. The week 10 DAS28 Delta is determined by calculating the average change between the wk 0 and wk 10 DAS28.|Week 10|Participant data analyzed per protocol using the following DAS28 formula [(=0.56*SQRT(Tender Joint Count)+0.28*SQRT(Swollen Joint Count)+0.36*LN(CRP(mg/L)+1)+0.014*(Visual Analogue Scale+0.96 ]||Score Delta||Standard Deviation|Mean
740106|NCT00462072|Primary|Week 10 Disease Activity Score (DAS28)|The DAS28 for RA and PsA subjects is an outcome measure used in determining the severity of an individual's disease. This score is used to assess disease activity and to make and monitor treatment decisions. The week 10 DAS28 is an average of the study population's week 10 disease activity score after taking infliximab (remicade) for 10 weeks. A DAS28 score of higher than 5.1 is indicative of high disease activity, whereas a DAS28 below 3.2 indicates low disease activity. A subject is considered to be in remission if they have a DAS28 lower than 2.6.|Week 10|Participant data analyzed per protocol using the following DAS28 formula [(=0.56*SQRT(Tender Joint Count)+0.28*SQRT(Swollen Joint Count)+0.36*LN(CRP(mg/L)+1)+0.014*(Visual Analogue Scale+0.96 ]||Score||Standard Deviation|Mean
740107|NCT00462072|Primary|Baseline (Wk 0) Disease Activity Score (DAS28)|The DAS28 for RA and PsA subjects is an outcome measure used in determining the severity of an individual's disease. This score is used to assess disease activity and to make and monitor treatment decisions. The baseline DAS28 is an average of the study populations baseline disease activity score prior to the administration of Infliximab (remicade). A DAS28 score of higher than 5.1 is indicative of high disease activity, whereas a DAS28 below 3.2 indicates low disease activity. A subject is considered to be in remission if they have a DAS28 lower than 2.6.|Baseline (Wk 0)|Participant data analyzed per protocol using the following DAS28 formula [(=0.56*SQRT(Tender Joint Count)+0.28*SQRT(Swollen Joint Count)+0.36*LN(CRP(mg/L)+1)+0.014*(Visual Analogue Scale+0.96 ]||Score||Standard Deviation|Mean
740108|NCT00462228|Secondary|Improvements From Baseline Scores After 6 and 12 Weeks of Memantine Compared to Placebo on the Symbol Digit Modality Test (SDMT) Oral Score.|SDMT Oral Score: SDMT requires the subject to substitute a number for its corresponding geometric figure. There are nine figures. On the record form, there are a series of rows containing geometric figures in the top half, but the bottom half is left blank. When it is clear that the subject understands the task, he or she is told to fill in the remaining boxes as quickly as possible, completing one box at a time, one row at a time, before proceeding to the next. Skipping from box to box with the same geometric figure is not permitted. Subjects receive one point for each correctly completed box. The total score is the total number of correctly completed boxes in the time allowed. The practice items are not counted in the scoring. The test can be administered by having the subject write out the correct response or by having the subject report the correct answer (i.e., number) aloud. Higher scores are better scores and the range of scores can be from 0 to 110 for SDMT oral scores.|Baseline, 6 weeks, and 12 weeks after beginning memantine or placebo|All subjects completing the study.||units on a scale||Standard Deviation|Mean
740157|NCT00462345|Secondary|C-reactive Protein (CRP) Level|The mean level of CRP in milligrams per liter (mg/L), an acute phase reactant, at Week 0 and the change from Week 0 to Weeks 24 and 48.|Baseline, Weeks 24 and 48|ITT population||mg/L||Standard Deviation|Mean
740109|NCT00462228|Secondary|Improvements From Baseline Scores After 6 and 12 Weeks of Memantine Compared to Placebo on the Symbol Digit Modality Test (SDMT)Written Score.|SDMT Written Scores. SDMT requires the subject to substitute a number for its corresponding geometric figure. There are nine figures. On the record form, there are a series of rows containing geometric figures in the top half, but the bottom half is left blank. When it is clear that the subject understands the task, he or she is told to fill in the remaining boxes as quickly as possible, completing one box at a time, one row at a time, before proceeding to the next. Skipping from box to box with the same geometric figure is not permitted. Subjects receive one point for each correctly completed box. The total score is the total number of correctly completed boxes in the time allowed. The practice items are not counted in the scoring. The test can be administered by having the subject write out the correct response or by having the subject report the correct answer (i.e., number) aloud. Higher scores are better scores and the range of scores can be from 0 to 110 for SDMT written scores.|baseline, 6 weeks, 12 weeks|All subjects completing the study.||units on a scale||Standard Deviation|Mean
740110|NCT00462228|Primary|Improvements From Baseline Scores After 6 and 12 Weeks of Memantine Compared to Placebo on the Brief VisuoSpatial Memory Test Revised (BVMT-R) Delayed Recall Score.|"BVMT-R Delayed recall. Each of the six equivalent, alternate BVMT-R stimulus forms consists of six geometric figures, printed in a 2 x 3 array, on a separate page of the Recall Stimulus Booklet. In the three Learning Trials, the respondent views the Recall Stimulus page for 10 seconds, then is asked to draw as many of the figures as possible, in their correct page locations.
After a 25-minute delay, which includes primarily verbal activities, the task is repeated. The respondent is asked to identify which of the 12 figures in the Recognition Stimulus Booklet were included in the 6 geometric figures on the original Recall Stimulus page.
These scores are for the delayed recall raw score which ranges from 0 to 12 with 12 being the highest and best possible score."|Baseline, 6 weeks, and 12 weeks after beginning memantine or placebo|All subjects completing the study.||units on a scale||Standard Deviation|Mean
740111|NCT00462228|Primary|Improvements From Baseline Scores After 6 and 12 Weeks of Memantine Compared to Placebo on the Brief VisuoSpatial Memory Test Revised (BVMT-R) Total Recall Score.|"BVMT-R total recall score. Each of the six equivalent, alternate BVMT-R stimulus forms consists of six geometric figures, printed in a 2 x 3 array, on a separate page of the Recall Stimulus Booklet. In the three Learning Trials, the respondent views the Recall Stimulus page for 10 seconds, then is asked to draw as many of the figures as possible, in their correct page locations. The total recall score is the sum of the three learning trials.
After a 25-minute delay, which includes primarily verbal activities, the task is repeated. The respondent is asked to identify which of the 12 figures in the Recognition Stimulus Booklet were included in the 6 geometric figures on the original Recall Stimulus page.
These scores are for the total recall raw score which ranges from 0-36 with 36 being the highest and best possible score."|Baseline, 6 weeks, 12 weeks after beginning Namenda or placebo|All subjects who completed the study.||units on a scale||Standard Deviation|Mean
740112|NCT00462228|Secondary|Improvements From Baseline Scores After 6 and 12 Weeks of Memantine Compared to Placebo on the Trail Making Test Part B.|Trail Making Test Part B consists of 24 circles on a piece of paper, but rather than all of the circles containing numbers, half of the circles have the numbers 1-12 in them and the other half (12) contain the letters A-L. The person taking the test has the more difficult task of drawing a line from one circle to the next in ascending order; however, he must alternate the circles with numbers in them (1-13) with circles with letters in them (A-L). In other words, he is to connect the circles in order like this: 1-A-2-B-3-C-4-D-5-E and so on. Lower scores are better scores and the range of scores can be from 0 to no limit for Trail Making Test part B. This is a timed test and the number of seconds to complete the task is recorded.|Baseline, 6 weeks, and 12 weeks after beginning memantine or placebo|All subjects completing the study.||seconds||Standard Deviation|Mean
740113|NCT00462228|Secondary|Improvements From Baseline Scores After 6 and 12 Weeks of Memantine Compared to Placebo on the Trail Making Test Part A.|Trail Making Test Part A consists of 25 circles on a piece of paper with the numbers 1-25 written randomly in the circles. The test taker’s task is to start with number one and draw a line from that circle to the circle with the number two in it to the circle with the three in it, etc. The person continues to connect the circles in numerical order until they reach number 25. Lower scores are better scores and the range of scores can be from 0 to no limit for Trail Making Test part A. This is a timed test and the number of seconds to complete the task is recorded.|baseline, 6 weeks, 12 weeks|||seconds||Standard Deviation|Mean
740114|NCT00462228|Primary|Improvements From Baseline Scores After 6 and 12 Weeks of Memantine Compared to Placebo on the Hopkins Verbal Learning Test Revised (HVLT-R) Delayed Recall Scores.|"HVLT-R Learning Scores provide a brief assessment of immediate recall, delayed recall and delayed recognition. It is administered by reading the words aloud, then asking the client to verbally repeat the list of words (immediately; then after a delay), and identify the words from a word list that is presented verbally.
The HVLT-R is easy to administer and score, and is well-tolerated by even significantly-impaired individuals. Tasks include three learning trials, which, when combined produce a total recall raw score; a delayed recall (25-30 minute delay) trial, and a yes/no delayed recognition trial. Raw scores are derived for Total Recall, Delayed Recall, Retention (percent retained) and a Recognition Discrimination Index.
These scores are for the delayed recall learning raw score. The HVLT-R delayed recall raw score ranges from 0 to 12 with 12 being the highest and best possible score."|Baseline, 6 weeks, and 12 weeks after beginning memantine or placebo|All subjects completing the study.||units on a scale||Standard Deviation|Mean
740115|NCT00462228|Primary|Improvements From Baseline Scores After 6 and 12 Weeks of Memantine Compared to Placebo on the Hopkins Verbal Learning Test Revised (HVLT-R) Total Recall Learning Scores.|"HVLT-R Learning Scores provide a brief assessment of immediate recall, delayed recall and delayed recognition. It is administered by reading the words aloud, then asking the client to verbally repeat the list of words (immediately; then after a delay), and identify the words from a word list that is presented verbally.
The HVLT-R is easy to administer and score, and is well-tolerated by even significantly-impaired individuals. Tasks include three learning trials, which, when combined produce a total recall score; a delayed recall (25-30 minute delay) trial, and a yes/no delayed recognition trial. Raw scores are derived for Total Recall, Delayed Recall, Retention (percent retained) and a Recognition Discrimination Index.
These results are for the HVLT-R total recall raw learning score. The HVLT-R total recall raw learning score ranges from 0 to 36 with 36 being the highest and best possible score."|Baseline, 6 weeks, and 12 weeks after beginning memantine or placebo|All subjects completing the study.||units on a scale||Standard Deviation|Mean
740121|NCT00462280|Secondary|Change in Triglycerides (mg/dL) From Baseline After Treatment||Baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."||mg/dL||95% Confidence Interval|Mean
740122|NCT00462280|Secondary|Change in HDL (mg/dL) From Baseline After Treatment||Baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."||mg/dL||95% Confidence Interval|Mean
740123|NCT00462280|Secondary|Change in LDL (mg/dL) From Baseline After Treatment||Baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."||mg/dL||95% Confidence Interval|Mean
740124|NCT00462280|Secondary|Change in Cholesterol (mg/dL) From Baseline After Treatment||Baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."||mg/dL||95% Confidence Interval|Mean
740125|NCT00462280|Secondary|Serum and Molecular Biomarkers - Ki-67: Pathologist 4's Evaluation|Ki-67 expression was assessed via nuclear staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.|From baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."||percentage of cells that are positive||95% Confidence Interval|Mean
740126|NCT00462280|Secondary|Serum and Molecular Biomarkers - p21 (WAF1/CIP1): Pathologist 4's Evaluation|p21 expression was assessed via nuclear staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.|From baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."||percentage of cells that are positive||95% Confidence Interval|Mean
740127|NCT00462280|Secondary|Serum and Molecular Biomarkers - RelA: Pathologist 4's Evaluation|RelA expression was assessed via cytoplasmic staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.|From baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."||percentage of cells that are positive||95% Confidence Interval|Mean
740128|NCT00462280|Secondary|Serum and Molecular Biomarkers - VEGF: Pathologist 4's Evaluation|VEGF expression was assessed via cytoplasmic staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.|From baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."||percentage of cells that are positive||95% Confidence Interval|Mean
740129|NCT00462280|Secondary|Serum and Molecular Biomarkers - (n)-Cadherin: Pathologist 4's Evaluation|(n)-cadherin expression was assessed via cytoplasmic staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.|From baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."||percentage of cells that are positive||95% Confidence Interval|Mean
740130|NCT00462280|Secondary|Serum and Molecular Biomarkers - (e)-Cadherin: Pathologist 4's Evaluation|(e)-cadherin expression was assessed via cytoplasmic staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.|From baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."||percentage of cells that are positive||95% Confidence Interval|Mean
740131|NCT00462280|Secondary|Serum and Molecular Biomarkers - HIF1alpha: Pathologist 4's Evaluation|HIF1alpha expression was assessed via nuclear staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.|From baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."||percentage of cells that are positive||95% Confidence Interval|Mean
740132|NCT00462280|Secondary|Serum and Molecular Biomarkers - Ki-67: Pathologist 3's Evaluation|Ki-67 expression was assessed via nuclear staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.|From baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."||percentage of cells that are positive||95% Confidence Interval|Mean
740158|NCT00462345|Secondary|Patient Assessment of Pain (VAS)|The mean score of pain at Week 0 (baseline) and the change from Week 0 to Weeks 24 and 48 as assessed by participants using a 100-mm horizontal VAS, where the left endpoint indicated “No pain,” and the right endpoint indicated “Unbearable pain.” A negative change indicated improvement.|Baseline, Weeks 24 and 48|ITT population||mm||Standard Deviation|Mean
740133|NCT00462280|Secondary|Serum and Molecular Biomarkers - p21 (WAF1/CIP1): Pathologist 3's Evaluation|p21 expression was assessed via nuclear staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.|From baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."||percentage of cells that are positive||95% Confidence Interval|Mean
740134|NCT00462280|Secondary|Serum and Molecular Biomarkers - RelA: Pathologist 3's Evaluation|RelA expression was assessed via cytoplasmic staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.|From baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."||percentage of cells that are positive||95% Confidence Interval|Mean
740135|NCT00462280|Secondary|Serum and Molecular Biomarkers - VEGF: Pathologist 3's Evaluation|VEGF expression was assessed via cytoplasmic staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.|From baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."||percentage of cells that are positive||95% Confidence Interval|Mean
740136|NCT00462280|Secondary|Serum and Molecular Biomarkers - (n)-Cadherin: Pathologist 3's Evaluation|(n)-cadherin expression was assessed via cytoplasmic staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.|From baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."||percentage of cells that are positive||95% Confidence Interval|Mean
740137|NCT00462280|Primary|Histopathologic Regression of Target Atypical Nevi With Treatment - Pathologist 2's Evaluation|The level of atypia will be graded in a standard fashion which leads to seven levels of atypia, with zero being no atypia and six being a melanoma. For each patient, the change from baseline in the level of atypia was calculated. Only the Two Matched Nevi Group - Lovastatin and Two Matched Nevi Group - Placebo data were used and analyzed for the primary outcome. One-Large Nevi Group - Lovastatin and One-Large Nevi Group - Placebo sample data were not used or analyzed due to insufficient numbers.|From baseline up to 24 weeks|Only the Two Matched Nevi Group - Lovastatin and Two Matched Nevi Group - Placebo data were used and analyzed for the primary outcome. One-Large Nevi Group - Lovastatin and One-Large Nevi Group - Placebo sample data were not used or analyzed due to insufficient numbers.||score||Standard Deviation|Mean
740138|NCT00462280|Secondary|Serum and Molecular Biomarkers - (e)-Cadherin: Pathologist 3's Evaluation|(e)-cadherin expression was assessed via cytoplasmic staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.|From baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."||percentage of cells that are positive||95% Confidence Interval|Mean
740139|NCT00462280|Secondary|Serum and Molecular Biomarkers - HIF1alpha: Pathologist 3's Evaluation|HIF1alpha expression was assessed via nuclear staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.|From baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."||percentage of cells that are positive||95% Confidence Interval|Mean
740140|NCT00462280|Secondary|Total Nevus Number on Patient’s Back - Combined Three Reviewers' Evaluations|Assessed by photos of subjects’ back pre and post treatment. These photos will be used to count, by blinded evaluators, the number of nevi on the back pre and post therapy.|From baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."||pairs of photos|||Number
740141|NCT00462280|Secondary|Clinical Regression of Atypical Moles - Average of Three Reviewers' Evaluations|From close-up photos of target atypical nevi, lesions will be graded clinically. After unblinding of pre- or post-treatment status for photos, the grading score was as follows: 1= Post-treatment (Post-TX) photo shows a complete resolution of atypia relative to pre-treatment (Pre-TX) photo, 2 = Post-TX photo shows a strong lessening of atypia relative to Pre-TX photo, 3 = Post-TX photo shows a mild lessening of atypia relative to Pre-TX photo, 4 = Post-TX and Pre-TX photos show same degree of atypia, 5 = Pre-TX photo shows a mild lessening of atypia relative to Post-TX photo, 6 = Pre-TX photo shows a strong lessening of atypia relative to Post-TX photo, 7 = Pre-TX photo shows a complete resolution of atypia relative to Post-TX photo. The Wilcoxon rank sum test will be applied to compare the scores for patients treated with placebo vs. those treated with lovastatin.|From baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."||score||Standard Deviation|Mean
740159|NCT00462345|Secondary|Physician Global Assessment of Disease Activity (VAS)|"The mean score of the symptoms of RA at Week 0 and the change from Week 0 (baseline) to Weeks 24 and 48 as assessed by investigators using a 100-mm horizontal VAS, where the left endpoint indicated No disease activity” (no symptom, or no symptom of RA), and the right endpoint indicated “Maximum disease activity” (maximum RA activity). A negative change from Baseline indicated improvement."|Baseline, Weeks 24 and 48|ITT population||mm||Standard Deviation|Mean
740142|NCT00462280|Primary|Histopathologic Regression of Target Atypical Nevi With Treatment - Pathologist 1's Evaluation|The level of atypia will be graded in a standard fashion which leads to seven levels of atypia, with zero being no atypia and six being a melanoma. For each patient, the change from baseline in the level of atypia was calculated. Only the Two Matched Nevi Group - Lovastatin and Two Matched Nevi Group - Placebo data were used and analyzed for the primary outcome. One-Large Nevi Group - Lovastatin and One-Large Nevi Group - Placebo sample data were not used or analyzed due to insufficient numbers.|From baseline up to 24 weeks|Only the Two Matched Nevi Group - Lovastatin and Two Matched Nevi Group - Placebo data were used and analyzed for the primary outcome. One-Large Nevi Group - Lovastatin and One-Large Nevi Group - Placebo sample data were not used or analyzed due to insufficient numbers.||score||Standard Deviation|Mean
740143|NCT00462306|Secondary|Diagnosis of Pre-eclampsia Among Subjects With Positive Berlin Questionnaires|Number of subjects with obstetrician diagnosis of pregnancy induced hypertension (pre-eclampsia) among subjects with a positive compared to a negative Berlin questionnaire. The Berlin Questionnaire consists of three categories. Categories 1 and 2 are considered positive if 2 or more responses are positive category 3 is considered positive if 1 response is positive and/or the body mass index is greater than 30 kg per meter squared. A patient is considered to have a Positive Berlin Questionnaire if 2 or more categories are positive.|1-2minutes|Analysis per protocol||participants|||Number
740144|NCT00462306|Primary|Positive Berlin Questionnaire Indicative of Sleep Disordered Breathing|The Berlin Questionnaire consists of three categories designed to elicit information regarding snoring (category 1), daytime somnolence (category 2), and the presence of obesity and/or hypertension (category 3). Categories 1 and 2 are considered positive if 2 or more responses are positive category 3 is considered positive if 1 response is positive and/or the body mass index is greater than 30 kg per meter squared. A patient is considered to have a high likelihood of sleep disordered breathing if 2 or more categories are positive.|1-2 minutes|Pregnant Women presenting to Prentice Women's Hospital or non-pregnant women or childbearing age presenting for ambulatory surgery from 10/2005 to 9/2007 were selected randomly and asked to complete the survey.||participants|||Number
740145|NCT00462332|Secondary|Disease-free Survival||At 2 years from study entry||||||
740146|NCT00462332|Secondary|Event-free Survival||At 2 years from study entry||||||
740147|NCT00462332|Secondary|Length of Survival||At 2 years and a half from study entry|||years||Standard Deviation|Mean
740148|NCT00462332|Secondary|Toxicity|Number of AEs and SAEs|At 2 years from study entry||||||
740149|NCT00462332|Primary|Number of Patients With Complete Response|"Normal clinical or X-ray examination (lymph nodes, liver, spleen)
No symptoms
Lymphocytes higher or equal to 4.0 per 10^9/L
Neutrophils lower or equal to 1.5 per 10^9/L
Platelets >100 per 10^9/L
Hb >11.0 g/dL
Bone marrow lymphs according to age, lymphocytes <30%, no nodules."|At 2 years from study entry|||participants|||Number
740150|NCT00462345|Secondary|Modified Sharp Radiographic Joint Space Narrowing Score (JSN)|JSN Score: A total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint). Maximum total scores for JSN in the hands was 100 and in the feet was 48, for a maximum overall score of 148. Total JSN was for both hands and feet.|Screening, Weeks 24 and 48|ITT population. 39 participants were analyzed for this outcome measure.||scores on a scale||Standard Deviation|Mean
740151|NCT00462345|Secondary|Modified Sharp Radiographic Erosion Score (ES)|Erosion Score: A total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion. Maximum total erosion score in the hands was 100 and in the feet was 42, for a maximum overall score of 142. Total erosion score was for both hands and feet.|Screening, Weeks 24 and 48|ITT population||scores on a scale||Standard Deviation|Mean
740152|NCT00462345|Secondary|Modified Total Sharp-Genant Score (mTSS)|Posterior-anterior (PA) radiograph of each hand and anterior-posterior (AP) radiograph of each foot were taken separately and assessed according to Genant’s method as modified from Sharp’s method. The Sharp-Genant score=total of the erosion score and the joint space narrowing (JSN) score of all the hands and feet. Erosion Score: 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion. JSN Score:13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint). Maximum total erosion score in hands=100 and in feet=42; maximum scores for JSN in the hands=100 and in feet=48. Maximum modified Sharp score achievable is 290. A lower number change from Baseline indicated a better score. Change in scores was calculated as change=final score minus initial score.|Screening and Weeks 24 and 48|ITT population||scores on a scale||Standard Deviation|Mean
740153|NCT00462345|Secondary|SF-36 Mental Component Scores|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Screening, Weeks 24 and 48|ITT population; n=number of participants assessed for the specified parameter at a given visit.||scores on a scale||Standard Deviation|Mean
740154|NCT00462345|Secondary|Physical Function as Assessed by Short Form 36 (SF-36)|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Screening, Weeks 24 and 48|ITT population; n (number) = number of participants assessed for the specified parameter at a given visit.||scores on a scale||Standard Deviation|Mean
740155|NCT00462345|Secondary|HAQ-DI Score|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Weeks 24 and 48|ITT population||scores on a scale||Standard Deviation|Mean
740156|NCT00462345|Secondary|Erythrocyte Sedimentation Rate (ESR)|The mean level of ESR (in mm/hr), an acute phase reactant, at Week 0 and the change from Week 0 to Weeks 24 and 48.|Baseline, Weeks 24 and 48|ITT population||mm/hr||Standard Deviation|Mean
740160|NCT00462345|Secondary|Patient Global Assessment of Disease Activity (VAS)|"The mean score of the symptoms of rheumatoid arthritis (RA) at Week 0 (baseline) and the change from Week 0 to Weeks 24 and 48 as assessed by participants using a 100 mm horizontal VAS, where the left endpoint indicated No disease activity” (no symptom, or no symptom of RA), and the right endpoint indicated “Maximum disease activity” (maximum RA activity). A negative change from Baseline indicated improvement."|Baseline, Weeks 24 and 48|ITT population||mm||Standard Deviation|Mean
740161|NCT00462345|Secondary|Tender Joint Count (TJC)|Number of tender joints was determined by examination of 68 joints (as assessed through pressing and palpating during the physical examination) and identifying when swelling was present. The number of tender joints was recorded on the joint assessment form at each visit as either tender or not tender.|Baseline, Weeks 24 and 48|ITT population||tender joints||Standard Deviation|Mean
740162|NCT00462345|Secondary|Swollen Join Count (SJC)|Number of swollen joints was determined by examination of 66 joints (as assessed through pressing and palpating during the physical examination) and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit as swollen or not swollen.|Baseline, Weeks 24 and 48|ITT population||swollen joints||Standard Deviation|Mean
740163|NCT00462345|Secondary|Percentage of Participants With DAS Response by European League Against Rheumatism (EULAR) Category at Week 24|The percentage of participants categorized as good, moderate, or nonresponders according to the EULAR response criteria at Week 24. Participants were categorized as good responders if the intensity of their symptoms was in the “low disease activity (DAS28 less than [<]3.2)” category after treatment, and their symptoms significantly decreased to >1.2. Participants were categorized as moderate responders if the intensity of their symptoms was in the “moderate or high disease activity (DAS28 >3.2)” category after treatment, and the symptoms significantly decreased to >1.2; or if the intensity of their symptoms was in the “low or moderate disease activity (DAS28 <5.1)” category, and the DAS28 score changed more than 0.6 or 1.2 or less. Participants were categorized as non-responders if they did not fall into the good or moderate categories.|Week 24|ITT population||percentage of participants|||Number
740164|NCT00462345|Secondary|Percentage of Participants With Change in DAS-28 From BL to Week 24 of ≥1.2|DAS28 was calculated from the number of swollen joints and tender joints using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity.|Baseline, Week 24|ITT population||percentage of participants|||Number
740165|NCT00462345|Secondary|Disease Activity Score Based on 28-Joint Count (DAS-28)|DAS28 was calculated from the number of swollen joints and tender joints using the 28 joints count, the ESR (millimeters per hour [mm/hr]) and PtGA of disease activity with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 ≤3.2 equals (=) low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity.|Baseline and Week 24|ITT population||scores on a scale||Standard Deviation|Mean
740166|NCT00462345|Secondary|Percentage of Participants With An American College of Rheumatology 70% Improvement Criteria (ACR70) Response at Week 24|ACR70 response: ≥70% improvement in tender joint count; ≥70% improvement in swollen joint count; and ≥70% improvement in at least 3 of 5 remaining ACR core measures: Patient Assessment of Pain; PtGA; PGA; self-assessed disability (HAQ-DI); and either CRP or ESR.|Week 24|ITT population||percentage of participants||95% Confidence Interval|Number
740167|NCT00462345|Secondary|Percentage of Participants With An American College of Rheumatology 50% Improvement Criteria (ACR50) Response at Week 24|ACR50 response: ≥50% improvement in tender joint count; ≥50% improvement in swollen joint count; and ≥50% improvement in at least 3 of 5 remaining ACR core measures: Patient Assessment of Pain; PtGA; PGA; self-assessed disability (HAQ-DI); and either CRP or ESR.|Week 24|ITT population||percentage of participants||95% Confidence Interval|Number
740168|NCT00462345|Primary|Percentage of Participants With An American College of Rheumatology 20 Percent (%) Improvement Criteria (ACR20) Response at Week 24|ACR20 response: ≥20% improvement in tender joint count; ≥20% improvement in swollen joint count; and ≥20% improvement in at least 3 of 5 remaining ACR core measures: Patient Assessment of Pain; Patient Global Assessment of Disease Activity (PtGA); Physician Global Assessment of Disease Activity (PGA); self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ-DI]); and either C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR).|Week 24|ITT population||percentage of participants||95% Confidence Interval|Number
740169|NCT00462384|Secondary|Time Spent in Hemoglobin Range of 11.0 to 13.0 g/dL During the EEP|EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period.|EEP (Weeks 29 to 36)|ITT population||days||Standard Deviation|Mean
740170|NCT00462384|Secondary|Percentage of Participants Maintaining Average Hemoglobin Concentration Within Hemoglobin Range 11.0 to 13.0 g/dL During the EEP|EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period. The percentage of participants whose average hemoglobin concentration was within the range of 11.0-13.0 g/dL during the EEP is presented.|EEP (Weeks 29 to 36)|ITT population||percentage of participants|||Number
740171|NCT00462384|Secondary|Percentage of Participants Maintaining Hemoglobin Concentration Within Hemoglobin Range 11.0 to 13.0 g/dL Throughout the EEP|EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period. The percentage of participants whose hemoglobin concentrations remained within the range of 11.0-13.0 g/dL at all assessments throughout the EEP is presented.|EEP (Weeks 29 to 36)|ITT population||percentage of participants|||Number
740172|NCT00462384|Secondary|Time to Achievement of Response|Time to achievement of response was the time (number of days) required to achieve hemoglobin levels within the range of 11.0 to 13.0 g/dL.|Baseline to Week 40|ITT population||days||Standard Deviation|Mean
740173|NCT00462384|Primary|Mean Change in Hemoglobin Concentration Between Baseline and the Efficacy Evaluation Period (EEP)|The baseline hemoglobin was defined as the mean of the assessments recorded during the screening period (Weeks -2 and 0). EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period. EEP hemoglobin was defined as the mean of the assessments recorded during the EEP.|Baseline (Week -2 to 0) and EEP (Weeks 29 to 36)|Intent to treat (ITT) population: included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta and for whom data for at least one study variable was available.||grams per deciliter (g/dL)||Standard Deviation|Mean
740174|NCT00462423|Secondary|Safety and Tolerability of This Combination|See adverse events Table|April 2007 through December 2010||||||
740179|NCT00462449|Secondary|Change From Baseline in Self-performance in Activities of Daily Living Assessed With the (MAL - Self Report)|upper extremity function during activities of daily living as reported by the patient. Scale runs 0 (not used) to 5 (normal function). No subscales used.|12 weeks|Per protocol||units on a scale||95% Confidence Interval|Mean
740180|NCT00462449|Secondary|Change From Baseline in Dexterous Hand Function as Measured by the Action Research Arm Test (ARAT)|Dextrous hand function measurement. Scale ranges from 0 (no dextrous arm function) to 57 (normal function)|12 weeks|Per protocol.||units on a scale||95% Confidence Interval|Mean
740181|NCT00462449|Primary|Change From Baseline in Arm Function Based on Motor Activities Log (MAL-O)|upper extremity function during activities of daily living based on observer ratings. Scale runs 0 (not used) to 5 (normal function). No subscales used.|12 weeks|Per protocol. Number was determined based on the number of participants enrolled and eligible.||units on a scale||95% Confidence Interval|Mean
740182|NCT00462462|Secondary|Patient Benefit||study end||||||
740183|NCT00462462|Secondary|Change in Volume of Congenital Venous Malformation (CVM) From Screening to Study End (Day 112 Visit).||Screening and study end (Day 112)|||cm3||Standard Deviation|Mean
740184|NCT00462462|Secondary|Systemic (Cardiopulmonary, Hematological, Metabolic) and Local Outcome of the Two Test Products.||Study end||||||
740185|NCT00462462|Primary|Systemic Exposure to Ethanol With the Two Test Products: Determination of the Maximum Plasma Concentration (Cmax)|Blood samples were performed, just before infusion, then 5 min, 10 min, 20 min, 40 min, 60 min, 90 min, and 120 min after infusion at the first site, then every 60 min onwards until ethanol levels are found under the detection limit. Cmax was estimated directly from experimental data. If all the ethanol concentrations of a patient was below the limit of quantification of the laboratory (LOQ), Cmax was reported as LOQ/2 for this patient.|Baseline visit (just before and during test product infusion procedure)|||g/L||Full Range|Mean
740186|NCT00462501|Primary|Complete Pathologic Response|This will be assessed on the basis of the surgical pathology report.|3 years|||participants|||Number
740187|NCT00462605|Secondary|Change in the Percentage of Cells With Normal and Abnormal Myeloid Phenotype Measured by Flow Cytometry||Baseline and 6, 12, 24, and 36 weeks|Due to the limited number of clinical responders, the research assay was not done.|||||
740188|NCT00462605|Secondary|Changes in Detectable Chromosomal Abnormalities Measured by Fluorescent in Situ Hybridization (FISH)||Baseline and 6, 12, 24, and 36 weeks|Due to the limited number of clinical responders, the research assay was not done.|||||
740189|NCT00462605|Secondary|Clinical Activity Assessed by Change in Transfusion Requirements||Baseline and after 2 cycles|Due to the limited number of clinical responders, this outcome was not measured.|||||
740190|NCT00462605|Secondary|Clinical Activity Assessed by Change in Peripheral Blood Counts||Baseline and after 2 cycles|||cell/mm^3||Standard Error|Mean
740191|NCT00462605|Primary|Response (Complete and Partial Response) in Patients With Myeloid Disorders|Response to treatment was assessed after two cycles, according to International Working Group (IWG) criteria. Cytogenetic responses were monitored in patients with abnormalities at baseline.|Up to 2 years|||Participants|||Count of Participants
740192|NCT00462644|Secondary|Number of Deaths|deaths|death in hospital|||participants|||Number
740193|NCT00462644|Primary|Cortisol Level 60 Minutes After Cortisol Stimulating Test (CST)||60 minutes after administration of cotrosyn|||micrograms/dL||Standard Deviation|Mean
740194|NCT00462644|Primary|Change in Baseline Cortisol|change from baseline cortisol (drawn prior to RSI) to 2nd cortisol level (4-6hrs after RSI, but before stim test)|4-6hr after RSI|||micrograms/dL||Standard Deviation|Mean
740195|NCT00462644|Primary|Postintubation Cortisol (Baseline Cortisol Level)|cortisol level after randomization and rapid sequence induction|postintubation (baseline cortisol level)|||micrograms/dL||Standard Deviation|Mean
740196|NCT00462644|Secondary|Ventilator Days||time from intubation to extubation|||days||Standard Deviation|Mean
740197|NCT00462644|Secondary|Intensive Care Unit (ICU) Length of Stay|ICU length of stay in days|time from hospital admission to transfer out of ICU to floor bed|||days||Standard Deviation|Mean
740198|NCT00462644|Secondary|Hospital Length of Stay|days from admission to hospital discharge|time to hospital discharge in days|||days||Standard Deviation|Mean
740199|NCT00462644|Primary|Cortisol Levels Pre and Post Rapid Sequence Induction and Cortisol Stimulation Test||pre RSI, 4-6 hours post RSI, and again 60 mins later following ACTH stimulation test||||||
740200|NCT00462670|Secondary|Body Weight (Percent Change)|Percent change in body weight from baseline at the time of final trial drug administration|baseline, Day 7 or at the time of final trial drug administration|||percentage of body weight (Kg)||Standard Deviation|Mean
740201|NCT00462670|Primary|Body Weight (Amount of Change)|Change in body weight from baseline at the time of final trial drug administration|baseline, Day 7 or at the time of final trial drug administration|||Kg||Standard Deviation|Mean
740202|NCT00462709|Other Pre-specified|Complement C4 Serum Levels|Change from pre-infusion to 1 hour post-infusion in complement C4 serum levels.|Pre-infusion to 1 hour post-infusion|ITT-E subjects with data at both sampling time points (N=134).||mg/dL||Standard Deviation|Mean
740203|NCT00462709|Other Pre-specified|Functional C1INH Serum Levels|"Change from pre-infusion to 1 hour post-infusion in functional C1INH serum levels.
Functional C1INH serum levels are expressed as a percent of total detectable C1INH (i.e., functional C1INH/total detectable C1INH)."|Pre-infusion to 1 hour post-infusion|ITT-E subjects with data at both sampling time points (N=132).||percent||Standard Deviation|Mean
740204|NCT00462709|Other Pre-specified|Antigenic C1 Inhibitor (C1INH) Serum Levels|Change from pre-infusion to 1 hour post-infusion in antigenic C1INH serum levels.|Pre-infusion to 1 hour post-infusion|ITT-E subjects with data at both sampling time points (N=137).||mg/dL||Standard Deviation|Mean
740205|NCT00462709|Primary|Frequency of All HAE Attacks|A hereditary angioedema (HAE) attack was defined as a discrete episode during which the subject progressed from no angioedema to symptoms of angioedema.|Duration of the study|Intent-to-treat Efficacy (ITT-E) Population (N=146; the number of subjects who received at least one prophylactic dose of C1INH-nf for the prevention of HAE attacks). HAE attack frequency was reported by 137 subjects at screening (i.e., data were missing for 9 subjects).||attacks per month||Full Range|Median
740206|NCT00462722|Secondary|Expression of Selected Proteins and Genes Associated With Muscle Build-up and Breakdown||Baseline and after 9 months of training|Because of the costs associated with gene and protein expression techniques and data reduction, we did not pursue this secondary outcome after learning the results of the primary outcome (change in fat-free mass).|||||
740209|NCT00462722|Secondary|Percentage Change From Baseline in Sub-trochanter Bone Mineral Density (BMD) at 9 Months||Baseline and after 9 months of training|"One participant in the Placebo pre and post exercise group and two participants in the Ibuprofen pre and placebo post exercise groups had uninterpretable hip scans."||percentage change in BMD||Standard Deviation|Mean
740210|NCT00462722|Secondary|Percentage Change From Baseline in Trochanter Bone Mineral Density (BMD) at 9 Months||Baseline and after 9 months of training|||percentage change in BMD||Standard Deviation|Mean
740211|NCT00462722|Secondary|Percentage Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at 9 Months||Baseline and after 9 months of training|"One participant in the Placebo pre and post exercise group and two participants in the Ibuprofen pre and placebo post exercise group had uninterpretable spine scans."||percentage change in BMD||Standard Deviation|Mean
740212|NCT00462722|Primary|Change From Baseline in Fat-free Mass at 9 Months||Baseline and after 9 months of training|||change in kg||Standard Deviation|Mean
740213|NCT00462722|Primary|Percentage Change From Baseline in Total Hip Bone Mineral Density (BMD) at 9 Months||Baseline and after 9 months of training|"One participant in the Placebo pre and post exercise group and two participants in the Ibuprofen pre and placebo post exercise group had uninterpretable hip scans."||percentage change in total hip BMD||Standard Deviation|Mean
740214|NCT00462722|Primary|Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 9 Months||Baseline and after 9 months of training|"One participant in the Ibuprofen pre and placebo post exercise group had an uninterpretable spine scan."||Percentage change in lumbar spine BMD||Standard Deviation|Mean
740215|NCT00462748|Primary|Percentage of Patients Achieving a Target of Fasting LDL-C of <2mmol/l at Study End|Fasting LDL-C was the primary efficacy variable. The primary efficacy analysis was based on the proportion of patients achieving a target of <2mmol/l in fasting LDL-C at study end.|6 Weeks|"The Full Analysis Set (FAS) all patients who were:
Randomised
Took at least one dose of double-blind medication
Had a baseline measurement of efficacy
Had a post-baseline measurement of efficacy
Patients were analysed according to the treatment group they were randomised, regardless of the treatment they received"||Percent|||Number
740216|NCT00462826|Secondary|Duration of Overall Survival||From entry into the study to death or the date of last contact, up to 5 years||||||
740217|NCT00462826|Secondary|Duration of Progression-free Survival||From study entry until disease progression, death or date of last contact, up to 5 years||||||
740218|NCT00462826|Primary|Frequency and Severity of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0||Up to 5 years||||||
740219|NCT00462826|Primary|Objective Tumor Response||At 6 months||||||
740220|NCT00462826|Primary|6 Month Progression-free Survival|Number of participants who survived progression-free for more than 6 months.|At 6 months|||participants|||Number
740221|NCT00462839|Secondary|Number of Years of Clinical Experience Providing Patient Care Requiring Blood Loss Estimation.||1 hour|||participants|||Number
740222|NCT00462839|Secondary|Level of Training||1 hour|||participants|||Number
740223|NCT00462839|Secondary|Number and Type of Care Providers Assigned to Study Arms.||1 hour|per protocol||participants|||Number
740224|NCT00462839|Primary|Difference in Actual Blood Volume and Estimated Blood Volume in Milliliters.|Two types of drapes were used: drapes with and without volume calibrations. Calibrated drapes had volume markings beginning at 500ml with 500ml increments to a total of 2500ml. The participants were asked to estimate the volume contained in the bag and the difference in milliliters between the estimate and actual volume was calculated.|1 hour|per protocal||milliliters||95% Confidence Interval|Mean
740225|NCT00462865|Secondary|To Monitor the Rate of Recurrent Disease, Either Local This Population.||6 months and again at the end of the study (1 year)||||||
740226|NCT00462865|Primary|Toxicity Issues of Administering 6 Cycles of Gemcitabine, Capecitabine, and Avastin and One Year of Consolidation of Avastin in Women With Breast Cancer Previously Treated With Neoadjuvant Chemotherapy That Lead to Patients Being Taken Off Study.|6 out of 17 patients came off study for toxicity prior to receiving all treatment.|1 year|||participants|||Number
740227|NCT00462917|Secondary|Impact of Events Scale (IES)|A 15-item scale measuring distress specific to the test results received. Scores range from 0-75, with higher scores indicating greater test-related distress.|6 weeks, 6 months, 12 months post-disclosure|"Number of participants analyzed are the number of participants who received genetic risk information and completed the 6-week follow-up (256). At 6 months, 252 participants provided data. At 12 months, 247 participants provided data."||units on a scale||Standard Deviation|Mean
740228|NCT00462917|Primary|Beck Anxiety Inventory (BAI)|A 21-item scale measuring general anxiety. Scores range from 0-63, with higher scores indicating greater anxiety.|6 weeks, 6 months, 12 months post-disclosure|"Number of participants analyzed are the number of participants who received genetic risk information and completed the 6-week follow-up (256). At 6 months, 252 participants provided data. At 12 months, 247 participants provided data."||units on a scale||Standard Deviation|Mean
740229|NCT00462917|Primary|Center for Epidemiological Studies-Depression Scale (CES-D)|A 20-item scale measuring general depression. Scores range from 0-60, with higher scores indicating greater general depression.|6 weeks, 6 months, and 12 months post-disclosure|"Number of participants analyzed are the number of participants who received genetic risk information and completed the 6-week follow-up (256). At 6 months, 252 participants provided data. At 12 months, 247 participants provided data."||units on a scale||Standard Deviation|Mean
740272|NCT00463047|Secondary|Pain Relief Score (PR) at 15 Minutes|The PR score 15 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete).|15 minutes after treatment with study drug|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.||Units on a scale||Standard Deviation|Mean
740247|NCT00462982|Primary|Central Nervous System (CNS) Response Rate by RECIST Criteria|Response and progression will be evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in RECIST. Measurable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques (CT, MRI, X-ray) or as >10 mm with spiral CT scan. This study will use a minimum diameter of 10 mm for measurable lesions in the brain, regardless of imaging modality. All tumor measurements must be recorded in millimeters (or decimal fractions of centimeters). All other lesions are considered non-measurable disease. Bone lesions, leptomeningeal disease, ascites, pleural/pericardial effusions, inflammatory breast disease, and cystic lesions are all nonmeasurable.|up to a year|||participants|||Number
740248|NCT00463047|Secondary|Pain Flare Treatment Satisfaction (PFTS) Questionnaire - Question 21 at Endpoint (End of Second Double-blind Treatment Period or Last Observation After Start of Treatment Period)|The PFTS is used to measure patient's satisfaction with study drug. Although the full scale has 25 questions, the question that is most useful (and least redundant with prior scales) for assessing the efficacy of the study drug is Question 21 which states: Which medication would you prefer to use when treating your pain flares? The subject can choose either: Prior medication, Study medication, or No preference. The number of subjects in each treatment group at the Endpoint (time of the last observation during the treatment period)who responded to each option is presented.|Endpoint (End of second double-blind treatment period or last observation after start of treatment period)|Double-blind safety analysis set: 88 subjects who received FBT and 94 subjects who received Oxycodone at any time during the double-blind treatment period who completed the PFTS questionnaire||Participants|||Number
740249|NCT00463047|Secondary|Pain Flare Treatment Satisfaction (PFTS) Questionnaire - Question 21 at the End of the Second Double-blind Treatment Period (Visit 6)|The PFTS is used to measure patient's satisfaction with study drug. Although the full scale has 25 questions, the question that is most useful (and least redundant with prior scales) for assessing the efficacy of the study drug is Question 21 which states: Which medication would you prefer to use when treating your pain flares? The subject can choose either: Prior medication, Study medication, or No preference. The number of subjects in each treatment group at the end of the second double-blind treatment period (Visit 6) who responded to each option is presented.|At the end of the second double-blind treatment period (Visit 6)|Double-blind safety analysis set: 83 subjects who received FBT and 87 subjects who received Oxycodone in the second double-blind period||Participants|||Number
740250|NCT00463047|Secondary|Pain Flare Treatment Satisfaction (PFTS) Questionnaire - Question 21 at the End of the First Double-blind Treatment Period (Visit 5)|The PFTS is used to measure patient's satisfaction with study drug. Although the full scale has 25 questions, the question that is most useful (and least redundant with prior scales) for assessing the efficacy of the study drug is Question 21 which states: Which medication would you prefer to use when treating your pain flares? The subject can choose either: Prior medication, Study medication, or No preference. The number of subjects in each treatment group at the end of the first double-blind treatment period (Visit 5) who responded to each option is presented.|The end of the first double-blind treatment period.|Double-blind safety analysis set: 88 subjects who received FBT and 90 subjects who received Oxycodone in the first double-blind period||Participants|||Number
740251|NCT00463047|Secondary|Breakthrough Pain Preference Questionnaire|The BTP preference questionnaire is a questionnaire used to measure patients’ preference for FBT or immediate-release oxycodone for management of BTP. The question is used to determine a patient’s preference between the study drugs given in the 2 double-blind treatment periods. The patient was asked to select 1 of the following: 1, a preference for study drug used in the 1st double-blind treatment period; 2, a preference for study drug used in the 2nd double-blind treatment period; or 3, no preference.|After completion of both double-blind treatment periods or early termination|Double-blind safety analysis set: 190 subjects who received both study drugs in this crossover study completed the Breakthrough Pain Preference Questionnaire after completing treatment||Participants|||Number
740252|NCT00463047|Secondary|Medication Performance Assessment 60 Minutes After-treatment|The medication performance assessment assessed study drug performance on a 5-point categorical scale of 0-4 (0=poor, 1=fair,2=good, 3=very good, 4=excellent) 60 minutes after administration of study drug during the double-blind treatment periods and for the first 5 BTP episodes after each visit during the open-label extension period were recorded in the patient’s paper diary. Patients were asked “How well did your study medication perform in controlling this breakthrough pain episode?” The number of episodes rated for each category were recorded.|60 minutes post-treatment|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.||Number of episodes treated|Participants||Number
740253|NCT00463047|Secondary|Medication Performance Assessment 30 Minutes After-treatment|The medication performance assessment assessed study drug performance on a 5-point categorical scale of 0-4 (0=poor, 1=fair,2=good, 3=very good, 4=excellent) 30 minutes after administration of study drug during the double-blind treatment periods and for the first 5 BTP episodes after each visit during the open-label extension period were recorded in the patient’s paper diary. Patients were asked “How well did your study medication perform in controlling this breakthrough pain episode?” The number of episodes rated for each category were recorded.|30 minutes post-treatment|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.||Number of episodes treated|Participants||Number
740254|NCT00463047|Secondary|Standard Rescue Medication Usage|Any use of standard rescue medication after the administration of study drug for relief of Breakthrough Pain (BTP) during the double-blind treatment phase was recorded in the patient’s diary. The number of breakthrough pain episodes for which study drug treatment was administered and which required rescue medication use was recorded.|During the administration of study drug during the double blind treatment periods.|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.||Number of episodes treated|Participants||Number
740255|NCT00463047|Secondary|Time to Meaningful Pain Relief (MPR) by Treatment, <=60 Minutes|The time to MPR was measured by stopwatch and scheduled questions at each time point up to 60 minutes after baseline during double-blind treatment periods. Meaningful pain relief was defined as a subject reduction of pain intensity that the subject found to be meaningful (substantive). For each category (<5, <10, <15, <30, <45, <60 min, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes for which the time to MPR fell into that category was compared. Here the number of episodes in which MPR was achieved in less than or equal to 60 minutes was compared.|Time of study drug administration until 60 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.||Number of episodes treated|Participants||Number
740256|NCT00463047|Secondary|Time to Meaningful Pain Relief (MPR) by Treatment, <=45 Minutes|The time to MPR was measured by stopwatch and scheduled questions at each time point up to 60 minutes after baseline during double-blind treatment periods. Meaningful pain relief was defined as a subject reduction of pain intensity that the subject found to be meaningful (substantive). For each category (<5, <10, <15, <30, <45, <60 min, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes for which the time to MPR fell into that category was compared. Here the number of episodes in which MPR was achieved in less than or equal to 45 minutes was compared.|From study drug administration until 45 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.||Number of episodes treated|Participants||Number
740273|NCT00463047|Secondary|Pain Relief Score (PR) at 10 Minutes|The PR score 10 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete).|10 minutes after treatment with study drug|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.||Units on a scale||Standard Deviation|Mean
740257|NCT00463047|Secondary|Time to Meaningful Pain Relief (MPR) by Treatment, <=30 Minutes|The time to MPR was measured by stopwatch and scheduled questions at each time point up to 60 minutes after baseline during double-blind treatment periods. Meaningful pain relief was defined as a subject reduction of pain intensity that the subject found to be meaningful (substantive). For each category (<5, <10, <15, <30, <45, <60 min, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes for which the time to MPR fell into that category was compared. Here the number of episodes in which MPR was achieved in less than or equal to 30 minutes was compared.|Time of study drug administration until 30 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.||Number of episodes treated|Participants||Number
740258|NCT00463047|Secondary|Time to Meaningful Pain Relief (MPR) by Treatment, <=15 Minutes|The time to MPR was measured by stopwatch and scheduled questions at each time point up to 60 minutes after baseline during double-blind treatment periods. Meaningful pain relief was defined as a subject reduction of pain intensity that the subject found to be meaningful (substantive). For each category (<5, <10, <15, <30, <45, <60 min, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes for which the time to MPR fell into that category was compared. Here the number of episodes in which MPR was achieved in less than or equal to 15 minutes was compared.|Time of study drug administration until 15 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.||Number of episodes treated|Participants||Number
740259|NCT00463047|Secondary|Time to Meaningful Pain Relief (MPR) by Treatment, <=10 Minutes|The time to MPR was measured by stopwatch and scheduled questions at each time point up to 60 minutes after baseline during double-blind treatment periods. Meaningful pain relief was defined as a subject reduction of pain intensity that the subject found to be meaningful (substantive). For each category (<5, <10, <15, <30, <45, <60 min, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes for which the time to MPR fell into that category was compared. Here the number of episodes in which MPR was achieved in less than or equal to 10 minutes was compared.|Time of study drug treatment until 10 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.||Number of episodes treated|Participants||Number
740260|NCT00463047|Secondary|Time to Meaningful Pain Relief (MPR) by Treatment, <= 5 Minutes|Time to MPR was measured by stopwatch and by scheduled questions at each time point up to 60 minutes after baseline during the double-blind treatment period. Meaningful pain relief was defined as a subject reduction of pain intensity that the subject found to be meaningful (substantive). For each category (<5, <10, <15, <30, <45, <60 minutes, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes for which the time to meaningful pain relief fell into that category was compared.|From time study drug was taken until 5 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.||Number of episodes treated|Participants||Number
740261|NCT00463047|Secondary|Time to Any Pain Relief (APR) by Treatment, <=60 Minutes|The time to APR was measured by stopwatch and scheduled questions at each time point up to 60 minutes after baseline during double-blind treatment periods. Any pain relief was defined as any subjective reduction in pain severity, even if not meaningful to patient. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes for which the time to APRfell into that category was compared. Here the number of episodes in which APR was achieved in less than or equal to 60 minutes was compared.|Time of study drug treatment until 60 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.||Number of episodes treated|Participants||Number
740262|NCT00463047|Secondary|Time to Any Pain Relief (APR) by Treatment, <=45 Minutes|The time to APR was measured by stopwatch and scheduled questions at each time point up to 60 minutes after baseline during double-blind treatment periods. Any pain relief was defined as any subjective reduction in pain severity, even if not meaningful to patient. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes for which the time to APRfell into that category was compared. Here the number of episodes in which APR was achieved in less than or equal to 45 minutes was compared.|Time of study drug treatment until 45 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.||Number of episodes treated|Participants||Number
740263|NCT00463047|Secondary|Time to Any Pain Relief (APR) by Treatment, <=30 Minutes|The time to APR was measured by stopwatch and scheduled questions at each time point up to 60 minutes after baseline during double-blind treatment periods. Any pain relief was defined as any subjective reduction in pain severity, even if not meaningful to patient. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes for which the time to APRfell into that category was compared. Here the number of episodes in which APR was achieved in less than or equal to 30 minutes was compared.|Time of study drug administration till 30 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.||Number of episodes treated|Participants||Number
740607|NCT00460525|Secondary|Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by ELISA at Day 150.|Titers of Anti-FMP2.1 antibody were determined by ELISA from sera collected at Day 150.|Day 150 after initial vaccination|Analyses are ITT. No imputation techniques were used.||Titer||95% Confidence Interval|Geometric Mean
740264|NCT00463047|Secondary|Time to Any Pain Relief (APR) by Treatment, <=15 Minutes|The time to APR was measured by stopwatch and scheduled questions at each time point up to 60 minutes after baseline during double-blind treatment periods. Any pain relief was defined as any subjective reduction in pain severity, even if not meaningful to patient. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes for which the time to APR fell into that category was compared. Here the number of episodes in which APR was achieved in less than or equal to 15 minutes was compared.|From study drug administration to 15 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.||Number of episodes treated|Participants||Number
740265|NCT00463047|Secondary|Time to Any Pain Relief (APR) by Treatment, <=10 Minutes|The time to APR was measured by stopwatch and scheduled questions at each time point up to 60 minutes after baseline during the double-blind treatment periods. Any pain relief was defined as any subjective reduction in pain severity, even if not meaningful to patient. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes for which the time to APR fell into that category was compared. Here the number of episodes in which APR was achieved in less than or equal to 10 minutes was compared.|From study drug treatment until 10 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.||Number of episodes treated|Participants||Number
740266|NCT00463047|Secondary|Time to Any Pain Relief (APR) by Treatment, <= 5 Minutes|Time to APR was measured by stopwatch and by scheduled questions at each time point up to 60 minutes after baseline during double-blind treatment period. Any pain relief was defined as any subjective reduction in pain severity, even if not meaningful to patient. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes for which the time to APR fell into that category was compared. Here the number of episodes in which APR was achieved in less than or equal to 5 minutes was compared.|From time was administered to 5 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.||Number of episodes treated|Participants||Number
740267|NCT00463047|Secondary|Percent Total Pain Relief at 60 Minutes Posttreatment (%TOTPAR)|The PR score at set intervals after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete). The maximum TOTPAR score that could be achieved at 60 minutes is equal to 16; thus, %TOTPAR at 60 minutes is (TOTPAR60 /16) times 100.The % TOTPAR achieved 60 minutes after the administration of study drug was calculated during the double-blind treatment phase.|From 5 minutes through 60 minutes after study drug treatment|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.||Percent change in units on a scale||Standard Deviation|Mean
740268|NCT00463047|Secondary|Total Pain Relief (TOTPAR60) at 60 Minutes|"The mean TOTPAR at 60 minutes will be calculated for each episode as the weighted sum of Pain Relief (PR) scores (5-point Likert scale, 0 = none to 4 = complete) at each assessment of PR (during the double-blind treatment period) until 60 minutes after study drug administration, as follows:
TOTPAR60 =(⅓ x PR5)+ (⅓ x PR10) +(⅓ x PR15)+ PR30 + PR45 + PR60. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry."|From 5 minutes to 60 minutes after dosing|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.||Units on a scale|Participants|Standard Error|Least Squares Mean
740269|NCT00463047|Secondary|Pain Relief Score (PR) at 60 Minutes|The PR score 60 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete).|60 minutes after treatment with study drug|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.||Units on a scale||Standard Deviation|Mean
740270|NCT00463047|Secondary|Pain Relief Score (PR) at 45 Minutes|The PR score 45 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete).|45 minutes after treatment with study drug|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.||Units on a scale||Standard Deviation|Mean
740271|NCT00463047|Secondary|Pain Relief Score (PR) at 30 Minutes|The PR score 30 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete).|30 minutes after treatment with study drug|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.||Units on a scale||Standard Deviation|Mean
740274|NCT00463047|Secondary|Pain Relief (PR) Score at 5 Minutes|The PR score 5 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient’s diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete).|Five minutes after administration of study drug|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.||Units on a scale||Standard Deviation|Mean
740275|NCT00463047|Secondary|Sum of Pain Intensity Difference at 60 Minutes Post-treatment (SPID60)|"PI scores were assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine during the double-blind treatment period. The SPID60 was derived from PID values. The SPID60 scores during the double-blind treatment phase were calculated as the time- weighted sum of the PID scores from 5 through 60 minutes,after the administration of the study drug.
SPID60 = SPID30 + PID45 + PID60. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry."|From 5 minutes after dosing through 60 minutes after dosing|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.||Units on a scale|Participants|Standard Error|Least Squares Mean
740276|NCT00463047|Secondary|Sum of Pain Intensity Difference at 30 Minutes Post-treatment (SPID30)|PI scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine. SPID30 were derived from PID values. The SPID30 scores during the double-blind treatment phase were calculated as the time- weighted sum of the PID scores from 5 through 30 minutes,after the administration of study drug. SPID30 = (⅓ x PID5) + (⅓ x PID10) + (⅓ x PID15) + PID30. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.|From 5 minutes after dosing through 30 minutes after dosing|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.||Units on a scale|Participants|Standard Error|Least Squares Mean
740277|NCT00463047|Secondary|Percentage Change in Pain Intensity Difference (%PID) at 60 Minutes|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID60 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 60 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score. The percentage is calculated as the PID at 60 minutes divided by the baseline PI score times 100.|Immediately before and 60 minutes after study drug administration|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.||Percent change in units on a scale||Standard Error|Mean
740278|NCT00463047|Secondary|Percentage Change in Pain Intensity Difference (% PID) at 45 Minutes|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID45 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 45 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score. The percentage is calculated as the PID at 45 minutes divided by the baseline PI score times 100.|Immediately before and 45 minutes after study drug administration|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.||Percent change in units on scale||Standard Error|Mean
740279|NCT00463047|Secondary|Percentage Change in Pain Intensity Difference (%PID) at 30 Minutes|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID30 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 30 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score. The percentage is calculated as the PID at 30 minutes divided by the baseline PI score times 100.|Immediately before and 30 minutes after study drug administration|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.||Percent change in units on a scale||Standard Error|Mean
740280|NCT00463047|Secondary|Percentage Change in Pain Intensity Difference (%PID) at 15 Minutes|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID15 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 15 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score. The percentage is calculated as the PID at 15 minutes divided by the baseline PI score times 100.|Immediately before and 15 minutes after administration of study drug|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.||Percent change in units on a scale||Standard Error|Mean
740281|NCT00463047|Secondary|Percentage Change in Pain Intensity Difference (%PID) at 10 Minutes|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID10 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 10 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score. The percentage is calculated as the PID at 10 minutes divided by the baseline PI score times 100.|Immediately before and 10 minutes after study drug administration|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.||Percentage change in units on a scale||Standard Error|Mean
740282|NCT00463047|Secondary|Percentage Change in Pain Intensity Difference (% PID) at 5 Minutes Post-treatment|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID5 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 5 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score. The percentage is calculated as the PID at 5 minutes divided by the baseline PI score times 100.|Immediately before and 5 minutes after administration of study drug|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.||Percent change in units on a scale||Standard Error|Mean
740283|NCT00463047|Secondary|Pain Intensity Difference (PID 60) at 60 Minutes|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID60 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 60 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.|Immediately before and 60 minutes after administration of study drug|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.||Units on a scale|Participants|Standard Error|Least Squares Mean
740284|NCT00463047|Secondary|Pain Intensity Difference (PID 45) at 45 Minutes|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID45 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 45 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.|Immediately before and 45 minutes after study drug administration|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.||Units on a scale|Participants|Standard Error|Least Squares Mean
740285|NCT00463047|Secondary|Pain Intensity Difference (PID 30) at 30 Minutes|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID30 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 30 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.|Immediately before and 10 minutes after study drug administration|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.||Units on a scale|Participants|Standard Error|Least Squares Mean
740286|NCT00463047|Secondary|Pain Intensity Difference (PID 10) at 10 Minutes|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID10 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 10 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.|Immediately before and 10 minutes after administration of study drug|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.||Units on a scale|Participants|Standard Error|Least Squares Mean
740298|NCT00463346|Primary|Psychotic Symptoms - Measured Using the PANSS|The PANSS or the Positive and Negative Syndrome Scale is a medical scale used for measuring symptom severity of patients with schizophrenia. The patient is rated from 1 to 7 on 30 different symptoms based on the interview as well as reports of family members or primary care hospital workers. Of the 30 items included in the PANSS, 7 constitute a Positive Scale, 7 a Negative Scale, and the remaining 16 a General Psychopathology Scale.The scores for these scales are arrived at by summation of ratings across component items. Therefore, the potential ranges are 7 to 49 for the Positive and Negative Scales, and 16 to 112 for the General Psychopathology Scale. A higher score indicates more severe symptoms.|12 weeks|||units on a scale||Standard Error|Mean
740299|NCT00463346|Primary|Number of Drinking Days||12 weeks|||days||Standard Deviation|Mean
740287|NCT00463047|Secondary|Pain Intensity Difference (PID 5) at 5 Minutes|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID5 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 5 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.|Immediately before and 5 minutes after study drug administration|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.||Units on a scale|Participants|Standard Error|Least Squares Mean
740288|NCT00463047|Primary|Pain Intensity Difference (PID15) At 15 Minutes|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID15 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 15 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.|Immediately pre-dose and fifteen minutes after administration of study drug|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.||Units on a scale|Participants|Standard Error|Least Squares Mean
740289|NCT00463229|Secondary|Kessler - 10|The Kessler-10 assesses level of anxiety and depressive symptoms a person may have experienced in the most recent four-week period. Its main strength is a superior ability to screen for anxiety and affective disorders. Each item is assigned a score ranging from 5 (all of the time) to 1 (none of the time). These 10 items are summed to give scores ranging from 10-50, where 50 indicates high risk of anxiety or depressive disorder. Previous studies have established a cut-off score of 16-29/50 for medium risk, and 30-50/50 as high risk for anxiety and depressive disorders.|Baseline (pre-randomization) and 12 months||09/2010||||
740290|NCT00463229|Secondary|Health and Social Services Utilization Inventory|The costs of use of all types of health services from baseline to 12 months were determined using the Health and Social Services Utilization Inventory (HSSUI), which assesses costs from a societal perspective. The HSSUI consists of questions about the respondent’s use of six categories of direct health care services: (1) primary care; (2) emergency department and specialists; (3) hospital days; (4) seven types of other health and social professionals; (5) medications; and (6) lab services. The product of the number of units of service (quantity) and unit cost (price) is total cost.|Baseline (pre-randomization) and 12 months||09/2010||||
740291|NCT00463229|Secondary|Personal Resource Questionnaire (PRQ85-Part Two)|The PRQ85–Part Two is a 25-item scale that measures perceived social support along five dimensions: provision for attachment/intimacy; social integration; opportunity for nurturing behaviour; reassurance of worth as an individual and in role accomplishments; and the availability of informational, emotional, and material help. The maximum score is 175; a higher score indicates a greater perception of social support.|Baseline (pre-randomization) and 12 months||09/2010||||
740292|NCT00463229|Secondary|Caregiver Reaction Assessment Scale.|The Caregiver Reaction Assessment Scale is a multidimensional, 5-factor measure designed to assess the negative and positive aspects of caregiving. Each item is scored from 1 to 5 from strongly disagree to strongly agree. There are five subscales: (a) esteem, (b) family support, (c) finances, (d) impact on schedule, and (e) impact on health.|Baseline (pre-randomization) and 12 months||09/2010||||
740293|NCT00463229|Secondary|Centre for Epidemiological Studies in Depression Scale (CES-D)|The CES-D scale is a 20-item, self-reported questionnaire that assesses the current frequency of depressive symptoms. Total scores can range from 0 to 60; the higher the score, the more depressed.|10 minutes||11/2009||||
740294|NCT00463229|Secondary|Short Portable Mental Status Questionnaire.|The 10-item Short Portable Mental Status Questionnaire (SPMSQ) is used for the screening, diagnosis and assessment of cognition. The SPMSQ is short, easily administered and has been designed, tested, standardized and validated in a variety of populations, including stroke. The SPMSQ consists of 10 items. The individual items sum to provide a total score; with greater than 4 errors indicating some degree of intellectual impairment.|Baseline (pre-randomization) and 12 months||09/2010||||
740295|NCT00463229|Secondary|Reintegration to Normal Living Index|The RNLI assesses global functional status and measures both the stroke survivors’ perceptions of their own capabilities and objective indicators of physical, social, and psychological performance. The RNLI consists of 11 items which cover the domains of mobility, self-care abilities, daily activities, recreational and social activities, family roles, and personal relationships, presentation of self and general coping skills. Each item is scored as 0 to 2. The individual items sum to provide a total score, with 22 indicating the highest degree of reintegration.|Baseline (pre-randomization) and 12 months||09/2010||||
740296|NCT00463229|Secondary|Stroke Impact Scale - 16|The SIS-16 assesses several aspects of health-related quality of life that are important to stroke survivors, caregivers, and healthcare professionals. The SIS-16 consists of 16 items which cover the physical aspects of stroke including: strength, hand function, mobility, and activities of daily living/instrumental activities of daily living. Each item is assigned a score ranging from 1 (could not do at all) to 5 (not difficult at all). The individual items sum to provide a total score, with higher scores indicating higher levels of health-related quality of life and function.|Baseline (pre-randomization) and 12 months||09/2010||||
740297|NCT00463229|Primary|SF-36 Physical Function Score to Measure the Change in Health-related Quality of Life and Function From Baseline (Pre-randomization)to 12 Months.|The primary measure of effect was the change in health-related quality of life and functioning from baseline to 12-months as measured by the SF-36 physical functioning score. The range of possible scores for this subscale is 0-100, with a higher score indicating a more favourable health status.|Baseline (pre-randomization) and 12 months|||Units on a scale||Standard Deviation|Mean
740300|NCT00463385|Secondary|Number of Participants With Adverse Events (AEs)|"A serious AE (SAE) was defined as any AE which resulted in death or was life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or constituted an important medical event (events that may have jeopardized the patient or required intervention to prevent one of the outcomes listed above).
The severity of AEs were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 3.0) or according to the following scale:
Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Life-threatening; Grade 5 = Death.
The Investigator determined the relationship between study drug and the occurrence of an AE as “Not Related” or “Related” (since the study was double-blinded, a patient receiving only prednisone could have an AE that was judged as related to pomalidomide, and vice-versa)."|From date of the first dose of the study drug until discontinuation or the data cut-off date (up to approximately 45 months).|Safety population (all treated patients).||participants|||Number
740301|NCT00463385|Secondary|Percentage of Participants With Clinical Response by Baseline JAK2 Assessment|Percentage of participants who achieved a clinical response, presented by participants with positive and negative janus kinase 2 (JAK2) V617F mutation results at Baseline.|Up to 336 days|Intent-to-treat population with non-missing JAK2 Baseline assessment results. The number of participants analyzed indicates the number of participants with a positive or negative JAK2 result for each treatment group respectively.||percentage of participants|||Number
740302|NCT00463385|Secondary|Change From Baseline in Likert Abdominal Pain Scale|Participants rated abdominal discomfort or pain over the previous week on a scale from zero to ten, where zero is no discomfort or pain and ten is the worst pain imaginable.|Baseline and Cycle 6 (168 days)|Intent-to-treat patients with available data.||units on a scale||Standard Deviation|Mean
740303|NCT00463385|Secondary|Change From Baseline in Hemoglobin Concentration for Non-Responders|Change from Baseline in hemoglobin for participants without a clinical response within the first 6 cycles of treatment.|Baseline, Cycle 6 (168 days)|Intent-to-treat participants with no clinical response and available hemoglobin values at each time point.||g/dL||Full Range|Median
740304|NCT00463385|Secondary|Change From Baseline in Hemoglobin Concentration for Responders|Change from Baseline in hemoglobin for participants with a clinical response within the first 6 cycles of treatment.|Baseline, Cycle 6 (168 days)|Intent-to-treat participants with a clinical response and available hemoglobin values at each time point.||g/dL||Full Range|Median
740305|NCT00463385|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Anemia (FACT-An) Subscale and Total Scores|"The FACT-An comprises the four subscales of the 27-item FACT-General Scale (FACT-G), Physical Well-being, Social/Family Well-being, Emotion Well-being, Functional Well-Being, and the Additional Concerns Anemia subscale. Questions are rated on a scale from 0 to 4, where higher scores indicate more impact on quality of life.
Physical Well-being consists of 7 questions, the subscale score ranges from 0-28;
Social/Family Well-being consists of 7 questions, the subscale score ranges from 0-28;
Emotion Well-being consists of 6 questions, the subscale score ranges from 0-24;
Functional Well-Being consists of 7 questions, the subscale score ranges from 0-28;
Anemia subscale consists of 20 questions, the subscale score ranges from 0-80;
Total FACT-An score ranges from 0-188."|Baseline and Cycle 6 (168 days).|Intent-to-treat patients with available data.||units on a scale||Standard Deviation|Mean
740306|NCT00463385|Secondary|Duration of First Clinical Response|"For RBC-transfusion-dependent patients, duration of response was calculated as the last day of response - first day of response +1, where the last day of response was the date of the first RBC-transfusion administrated at or more than 56 days after the response started. For patients who did not receive a subsequent transfusion after the response started, the end date of response was censored at the day of last hemoglobin assessment.
For RBC-transfusion-independent patients, the duration of response was calculated as the last day of response - first day of response +1, where the last day of response was the earlier of the date of a hemoglobin increase of < 2.0 g/dL and the date of a RBC transfusion at ≥ 56 days after the response started. For patients whose hemoglobin measurements were always ≥ 2.0 g/dL and never received a RBC transfusion after response started, the end date of the response was censored at the date of last hemoglobin measurement.
Kaplan-Meier methodology was used."|Up to 40 months|Intent-to-treat population with a clinical response.||months||95% Confidence Interval|Median
740307|NCT00463385|Secondary|Time to the First Clinical Response|"The time to the first clinical response achieved within 168 days after the first study drug dosing date was calculated for participants who achieved a clinical response as:
Start date of the first clinical response – the first study drug date +1.
A clinical responder was defined as either:
A baseline red blood cell (RBC)-transfusion-dependent participant with a ≥ 56 consecutive day RBC transfusion-free period after the first dose of study drug, or
A baseline RBC-transfusion-independent participant with an increase in hemoglobin of 2.0 g/dL or more from baseline for ≥ 56 consecutive days in the absence of RBC transfusions, or
A participant with either a ≥ 50% reduction in palpable splenomegaly of a spleen that was ≥ 10 cm at baseline or a spleen that was palpable at > 5 cm and became not palpable."|Up to 168 days|Intent-to-treat population with a clinical response||weeks||Full Range|Median
740308|NCT00463385|Secondary|Percentage of Participants With a Clinical Response Within the First 12 Cycles of Treatment|"A clinical responder was defined as either:
A baseline red blood cell (RBC)-transfusion-dependent participant with a ≥ 56 consecutive day RBC transfusion-free period after the first dose of study drug, or
A baseline RBC-transfusion-independent participant with an increase in hemoglobin of 2.0 g/dL or more from baseline for ≥ 56 consecutive days in the absence of RBC transfusions, or
A participant with either a ≥ 50% reduction in palpable splenomegaly of a spleen that was ≥ 10 cm at baseline or a spleen that was palpable at > 5 cm and became not palpable.
Participants who discontinued the study early without achieving clinical response were counted as non-responders."|Up to 336 days|Intent-to-treat (ITT), defined as as all patients who were randomized, independent of whether they received study treatment or not.||percentage of participants||95% Confidence Interval|Number
740322|NCT00470106|Secondary|Mean Test Score From a Test of Functional Capacity (Ability to Perform Daily Activities).|This is a role play demonstration test that measures how well someone handles social communication in daily life. The scores reflect overall effectiveness and are the mean number scored across different social situations with a range of 0-5 with higher being better. There are no norms for this test.|Assessments at endpoint (12 weeks).|||number correct||Standard Deviation|Mean
740309|NCT00463385|Primary|Percentage of Participants With a Clinical Response Within the First 6 Cycles of Treatment|"A clinical responder was defined as either:
A baseline red blood cell (RBC)-transfusion-dependent participant with a ≥ 56 consecutive day RBC transfusion-free period after the first dose of study drug, or
A baseline RBC-transfusion-independent participant with an increase in hemoglobin of 2.0 g/dL or more from baseline for ≥ 56 consecutive days in the absence of RBC transfusions, or
A participant with either a ≥ 50% reduction in palpable splenomegaly of a spleen that was ≥ 10 cm at baseline or a spleen that was palpable at > 5 cm and became not palpable.
Participants who discontinued the study early without achieving clinical response were counted as non-responders."|Up to 168 days|Modified intent-to-treat (MITT), defined as the patients who had a confirmed diagnosis of Myelofibrosis with myeloid metaplasia (MMM), received at least one dose of study drug, and participated in the study for at least 56 days.||percentage of participants||95% Confidence Interval|Number
740310|NCT00469456|Secondary|Change From Baseline in American Speech-Language-Hearing Association Functional Assessment of Communication Skills for Adults (ASHA FACS) [Total Score of Social Communication and Communication of Basic Needs Subscores] at Week 12|The ASHA FACS assesses & measures functional communication skills of adults with speech, language, & cognitive communication disorders. The measure, which comprises 43 items and takes approximately 20 minutes to complete, assesses functional communication in four areas: social communication; communication of basic needs; reading, writing, and number concepts; and daily planning. Total score of subdomains [Social Communication and Communication of Basic Needs] ranges from 0-196. A higher score denotes better communication.|Baseline to Week 12|The secondary efficacy analysis was based on the ITT Population. The last-observation-carried-forward approach was used to impute missing post-Baseline values.||Units on a scale||Standard Error|Least Squares Mean
740311|NCT00469456|Primary|Change From Baseline in Functional Linguistic Communication Inventory (FLCI) at Week 12|FLCI is a standardized & validated instrument for evaluating functional communication in pts with moderate-to-severe Alzheimer's that can be used to obtain Baseline information & to track patients' capabilities thereafter. The FLCI evaluates 10 areas: greeting and naming, answering questions, writing, sign comprehension, object-to-picture matching, word reading and comprehension, following commands, pantomime, gesture, and conversation. The FLCI total score ranges from 0 to 87, a higher score denotes better functional communication, and takes approximately 30 minutes to complete.|Baseline to Week 12|Primary efficacy analysis was based on the Intent-to-Treat (ITT) Population. The ITT Population will consist of all patients in the Safety Population who had at least one post-Baseline assessment of the primary efficacy parameter, FLCI. The last-observation-carried-forward approach was used to impute missing post-Baseline values.||Units on a scale||Standard Error|Least Squares Mean
740312|NCT00469508|Other Pre-specified|BDI Score|Self-reported depression: mean change on Beck Depression Index (BDI-II) assessed weekly during the 12 week medication phase. If the week12 measure was not available, the last observation was carried forward. 0 indicates no depression, 63 is the maximum indicating severe depression.|From baseline to end of treatment period (week 12).|Intention to treat, LOCF||units on a scale||Standard Deviation|Mean
740313|NCT00469508|Other Pre-specified|VAS Score|To measure methamphetamine craving, mean change in craving based on visual analog scale (VAS) from 0 (not at all) to 100 (extremely) from baseline to the last week of observation during the 12 week treatment period. The last observation was carried forward if not available during week 12.|baseline and last observation during the 12 week treatment period|Intention to treat, LOCF||units on a scale||Standard Deviation|Mean
740314|NCT00469508|Secondary|Retention|The number of persons who completed the medication phase of the trial (12 weeks of medication).|12 weeks|Intention to treat||participants|||Number
740315|NCT00469508|Primary|Clean Urine Drug Screen|Urine samples, collected thrice weekly, were tested for metabolites of MA using radioimmunoassay. Each subject had a possible of 36 urine drug screens to provide during the 12 weeks of medication. An aggregate measure of urine drug screen results was calculated - the Treatment Effectiveness Score (TES) - which is the average of the sum of MA-free urine specimens provided during the treatment period by participants in each treatment condition.|From randomization to end of week 12|Intention to treat||Clean urine drug screens|Participants|Standard Deviation|Mean
740316|NCT00470054|Secondary|Number of Participants With Grade 3 or Higher Adverse Events|"The National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 was used to evaluate toxicity.
Grade 1: mild; Grade 2: moderate; Grade 3: Severe; Grade 4: Life Threatening; Grade 5: Death."|Assessed during treatment|All 44 participants who received treatment were analyzed (including ineligible participants).||participants|||Number
740317|NCT00470054|Secondary|Overall Survival|Overall survival (OS) was defined as the time from registration to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% CI was estimated using the Kaplan Meier method.|Time from registration to death (up to 3 years)|All eligible participants were analyzed.||weeks||95% Confidence Interval|Median
740318|NCT00470054|Secondary|Response to Therapy|"Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria:
Complete Response (CR): disappearance of all target lesions;
Partial Response (PR) 30% decrease in sum of longest diameter of target lesions;
Progressive Disease (PD): 20% increase in sum of longest diameter of target lesions;
Stable Disease (SD): small changes that do not meet above criteria."|Assessed every 2 cycles (up to 3 years)|All eligible participants were analyzed.||participants|||Number
740319|NCT00470054|Secondary|Progression Free Survival (PFS)|"PFS was defined as the time from registration until disease progression or death, whichever occurs first. The median PFS with 95% CI was estimated using the Kaplan-Meier method.
Progression is defined as in the primary outcome measure."|Time from registration to progression (up to 3 years)|All eligible participants were analyzed.||weeks||95% Confidence Interval|Median
740320|NCT00470054|Primary|6 Week Progression Free Survival|"Percentage of patients who were alive and progression free at 6-weeks. The 6-week progression free survival was estimated using the Kaplan Meier method.
Progressive Disease was defined by the Response Evaluation Criteria In Solid Tumors (RECIST) criteria as 20% increase in sum of longest diameter of target lesions."|6 weeks|All eligible participants were analyzed.||percentage of participants||95% Confidence Interval|Number
740321|NCT00470067|Primary|Response (Complete and Partial)|Response Rate|Every 28 days|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.|||||
740323|NCT00470106|Primary|Mean Test Scores for Facial Emotion Identification.|This is a test of social cognition that measures the ability to identify the emotion shown in photos of still faces. The construct of interest is facial affect perception. It is an experimental measure and does not have norms or cut-offs. The range of accuracy scores is 0-56 with higher being better.|Assessments for end point (12 weeks).|||number of correct answers||Standard Deviation|Mean
740324|NCT00470158|Secondary|Percent Anemic||6 months||||||
740325|NCT00470158|Secondary|Change in Zinc Status||6 months||||||
740326|NCT00470158|Secondary|Change in Hemoglobin||6 months||||||
740327|NCT00470158|Primary|Incidence of Diarrhea|A diarrhea episode was defined as three or more loose, liquid, or watery stools for 2 consecutive days, separated in time from an earlier or subsequent episode by at least 2 consecutive diarrhea-free days.|6 months|||episodes|||Number
740328|NCT00470184|Secondary|Quality of Life Improved Rate||5.5 weeks|evaluable patients||percentage of patients||95% Confidence Interval|Number
740329|NCT00470184|Secondary|Median Time to Progression||5.5 weeks|Evaluable patients||months||95% Confidence Interval|Number
740330|NCT00470184|Secondary|Overall Response Rate (Complete and Partial Response) as Measured by RECIST Criteria After Course 1||5.5 weeks|evaluable patients||percentage of patients||95% Confidence Interval|Number
740331|NCT00470184|Primary|Complete Response||5.5 weeks|Evaluable Patients||percentage of patients||95% Confidence Interval|Number
740332|NCT00470262|Secondary|IMCL|Intramyocellular lipid was measured using immunohistochemistry (using oil Red O staining) in muscle biopsy specimens. Oil red O-stained muscle sections were magnified with an Olympus Provis (Tokyo, Japan) light microscope, and images were digitally captured by using a connected charge-coupled device camera (Sony, Tokyo, Japan). Fiber-typed and oil red O-stained fibers were matched. The oil red O staining intensity of either type 1 or 2 muscle fibers was quantified using National Institutes of Health Image program (http://rsb.info.nih.gov/nih-image/). By adjusting a density threshold, the software was set to recognize the presence of one fat droplet only if its highlighted surface was exceeding 0.40 μm2 or larger. Muscle lipid content was calculated by total area of lipid droplets in a given muscle fiber divided by the total area of the same fiber. The mean number of fibers analyzed per sample was 40 for type 1 and 2 muscle fibers|3 months|||% of lipid area stained||Standard Deviation|Mean
740333|NCT00470262|Primary|Insulin Sensitivity|Insulin sensitivity was measure through frequently sampled intravenous glucose tolerance test. Subjects presented to research center fasting. Blood samples were collected at -21, -11, and -1 minutes. At time t=0 initiates the start of the IVGTT and the injection of glucose into the non-sampling arm. The glucose dose was calculated as 11.4g/m2 of body surface area, given as a 50% dextrose solution. This glucose injection was administered over 60 seconds or less. At time t=20 minutes, an insulin dose of 0.04u/kg was administered over 30 seconds. Blood samples were collected at times t=2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 19, 22, 23, 24, 25, 27, 30, 40, 50, 70, 90, 100, 120, 140, 160, and 180. If blood sugar did not return to a steady state the test was continued to t= 210 or t= 240.|3 months|||mg*kg^-1*min^-1||Standard Deviation|Mean
740334|NCT00470275|Primary|Response|Any patient who is enrolled and receives at least one dose of cytarabine will be considered evaluable for response if (1) the patient demonstrates progressive disease while on protocol therapy or (2) the patient is observed on protocol therapy for at least one cycle. Patients who achieve a complete or partial response according to the RECIST (Response Evaluation Criteria In Solid Tumors) criteria will be considered responders for the study design. All other patients who are evaluable for response will be considered non-responders for the study.|the first six cycles of study chemotherapy (126 days)|||participants|||Number
740335|NCT00470301|Primary|Pathologic Complete Response Rate (pCR) Evaluated Using RECIST (Phase II)|An increase in the breast pCR from 15% (anticipated for chemotherapy alone) to 35% would be considered promising.|Up to 5 years|||participants||95% Confidence Interval|Number
740336|NCT00470301|Primary|Recommended Phase II Dose of Tipifarnib When Combined With Weekly Sequential Paclitaxel (Phase I)||2 weeks||||||
740337|NCT00470392|Secondary|Number of Subjects With a 1.5 Fold Increase in mRNA Expression of GRAMD1A and DMXL2|Based upon upregulated mRNA expression of MyxA in 1 out of 7 patients treated with Imiquimod, a list of alternative target genes responsive to Imiquimod was generated. The target mRNAs examined included GRAMD1A, IL2RA, TGHD1, DMXL2. The target gene was consider upregulated if there was a 1.5 fold increase in the mRNA expression of the target gene.|Biopsy samples for analysis were taken 1 hour post UVB treatment|||participants|||Number
740338|NCT00470392|Secondary|Number of Subjects With Improvement in Lesional Psoriasis Area and Assessment (PASI) Score After Imiquimod and UVB Treatment|The PASI is a disease burden measure that integrates area, erythema, thickness and scale of each target lesion. The severity score for each region is calculated by adding the scores for redness, thickness and scale (each of which are graded from 0 to 4). The maximum severity score is 12. The higher the PASI, the worse the disease. Thus, an improvement in PASI score is a lower score than the pre-treatment PASI.|2 weeks after Imiquimod and UVB|Per protocol.||participants|||Number
740339|NCT00470392|Primary|Number of Subjects With Elevated MyxA|Lesions were treated with either Imiquimod or Clobetasol cream. Lesions were subsequently treated with UVB and biopsied. From the biopsy samples obtained from the Imiquimod arm, quantitative PCR was performed to measure levels of Myx A, an imiquimod response gene.|Biopsy samples for analysis were taken 1 hour post UVB treatment|Per protocol.||participants|||Number
740340|NCT00470418|Secondary|Changes From Baseline in Clinical Measures of Cognition at Terminal Visit|Mini-Mental Status Exam (MMSE) 0(worst)-30(best); ADAS-cog 0 (best cognitive performance across multiple domains) - 70(worst); Activities of Daily Living (ADCS-ADL) 0(least capable of function in daily and instrumental activities)-54(best)|baseline and six weeks|||units on a scale||Standard Deviation|Mean
740341|NCT00470418|Primary|Safety Assessments: Number of Participants With Adverse Events|vital signs, physical exam, Symptom Checklist, complete blood count, serum chemistries, urinalysis, and electrocardiogram|Safety Labs, Physical Exams: 6 times over 7 weeks. Adverse Events assessed 21 times over the course of 7 weeks|||Participants|||Count of Participants
740342|NCT00470470|Secondary|Time to Progression|Progression will be evaluated in this study using the new international criteria proposed by the RECIST Committee. Time to progression will be estimated using the Kaplan-Meier method.|Time from the treatment start to the date of disease progression|||weeks||Inter-Quartile Range|Mean
740344|NCT00470535|Secondary|Correlation of Response, QOL, and Survival With EGFR, E-cadherin, P-cadherin, Vimentin, Cytokeratin, ki67, and Fibronectin and With Other Prognostic Variables, Such as Age and Tumor Grade||At Baseline|This study was terminated earlier due to a phase III study that showed this drug was not better than sorafenib so it didn't make sense to offer an inferior drug to patients.|||||
740345|NCT00470535|Secondary|Correlation of Smoking Status With Overall Survival||Every 3 weeks|This study was terminated earlier due to a phase III study that showed this drug was not better than sorafenib so it didn't make sense to offer an inferior drug to patients.|||||
740346|NCT00470535|Secondary|Change in Quality of Life (QOL) as Measured by EORTC PAN26 Every 3 Weeks During Study Therapy and After Completion of Study Therapy||Every 3 weeks|This study was terminated earlier due to a phase III study that showed this drug was not better than sorafenib so it didn't make sense to offer an inferior drug to patients.|||||
740347|NCT00470535|Secondary|Median Overall Survival||After every cycle|This study was terminated earlier due to a phase III study that showed this drug was not better than sorafenib so it didn't make sense to offer an inferior drug to patients.|||||
740348|NCT00470535|Secondary|Clinical Response (Complete and Partial Response) as Measured by RECIST Criteria||After every cycle|This study was terminated earlier due to a phase III study that showed this drug was not better than sorafenib so it didn't make sense to offer an inferior drug to patients.|||||
740349|NCT00470535|Primary|Progression-free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesion|Every cycle for up to 52 weeks|All treated and eligible patients||months||95% Confidence Interval|Median
740350|NCT00470548|Secondary|Number of Participants With Disease Control|Disease control is complete response plus partial response plus stable disease from the start of treatment to death or disease progression.|Up to 2 years|||Participants|||Count of Participants
740351|NCT00470548|Secondary|Number of Participants With Partial Response|At least a 30% decrease in the sum of the longest diameter of target lesions|Up to 2 years|||Participants|||Count of Participants
740352|NCT00470548|Secondary|Number of Participants With Stable Disease|Stable Disease is measured from the start of the treatment until the criteria for disease progression are met. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Up to 2 years|||Participants|||Count of Participants
740353|NCT00470548|Secondary|Number of Participants With Complete Response|Per RECIST criteria, complete response (CR) is defined as the disappearance of all target lesions.|Up to 2 years|||participants|||Number
740354|NCT00470548|Secondary|Duration of Overall Survival|From time of enrollment to the first observation of disease progression or death.|Up to 2 years|Of the 12 patients in the phase I component 10 were assessable for response. In the phase II component, 31 of 37 patients were evaluable for response.||months||Standard Error|Median
740355|NCT00470548|Primary|Number of Patients With Toxicities|Toxicities was evaluated based on the standard NCI CTCAE Version 3.0 grading criteria. Attributable grade ≥ 3 hematologic and non-hematologic toxicities are presented here.|Up to 1 year|||Participants|||Count of Participants
740356|NCT00470548|Primary|Number of Participants With Dose Limiting Toxicities|Dose limiting toxicity (DLT) was defined as any of the following occurring during the first cycle: Grade 4 thrombocytopenia, or grade 3 thrombocytopenia associated with bleeding, requirement for transfusion, febrile neutropenia, neutropenia with documented infection. Non-hematologic DLT included any other ≥ grade 3 non-hematologic toxicity that was clinically significant and considered by the investigator to be related to study drug. Alopecia and grade 3 allergic reaction/hypersensitivity with infusion were not considered DLTs.|Up to21 days|At dose level 1, 2 and 3 three participants were treated with no dose limiting toxicities. Three additional participants were treated at dose level 3 with no dose limiting toxicities.||participants|||Number
740357|NCT00470600|Secondary|Patient Demand of Narcotic Use (Post-operative Period, From Hour 6 to 28).|Patient demand of narcotic used by patients in each treatment group for analgesia, post-surgery.|Study hour-6 to hour-28|Demand of narcotic use was determined by PCA records or by chart if patient requested and not via PCA.||milligrams||Standard Deviation|Mean
740358|NCT00470600|Secondary|Secondary Endpoint: AUC-VAS at Rest (Post-operative Period, Hours 6-28)|"Measurement of the patient’s self assessment of pain at rest using a visual analog scale (VAS) during the post-operative period (study hour-6 through hour-28). VAS assessments document the patient's self reported level of pain from No pain (0 mm) to Worst possible pain (100 mm) on a 100 mm line. VAS assessments were performed immediately following surgery and at hours 6, 8, 12, 16, 20, 24 and 28 (for the primary endpoint)."|Study hour-6 through hour-28|Efficacy analyses were performed on the Intent to Treat (ITT) population and the Efficacy Evaluable Population (EEP). All randomized patients who received at least a partial dose of CTM were included in the ITT analyses. All data below represents the ITT analyses.||AUC-VAS pain v. time (mm*hr)||Standard Error|Least Squares Mean
740359|NCT00470600|Primary|AUC-VAS With Movement (Post-operative Period, Hour-6-28)|"Measurement of the patient’s self assessment of pain with movement using the validated visual analog scale (VAS) during the post-operative period (study hour-6 through hour-28). VAS assessments document the patient's self reported level of pain from No pain (0 mm) to Worst possible pain (100 mm) on a 100 mm line. VAS assessments were performed immediately following surgery [variable since every surgery has a unique length of time even if it is the same procedure] and at hours 6, 8, 12, 16, 20, 24 and 28 (for the primary endpoint)."|Study hour-6 through hour-28|Efficacy analyses were performed on the Intent to Treat (ITT) population and the Efficacy Evaluable Population (EEP). All randomized patients who received at least a partial dose of CTM were included in the ITT analyses. All data below represents the ITT analyses.||AUC-VAS pain v. time (mm*hr)||Standard Error|Least Squares Mean
740360|NCT00470626|Secondary|Mean Time to Retrieval Attempt|"Mean time to retrieval describes the average time filters were in place in the study group before a retrieval attempt was made.
A retrieval attempt describes a procedure in which a physician tried to remove a filter from a patient. The mean time to retrieval describes the average time filters were in place before a retrieval attempt was made."|up to 12 months|||days||Standard Deviation|Mean
740361|NCT00470626|Secondary|Successful Retrieval|Retrieval attempt describes a procedure in which a physician tried to remove a filter from a patient. A decision to remove a filter was made after determining that the patient no longer required the filter. Retrieval attempts were either successful (i.e., the filter was removed) or unsuccessful (i.e., the filter could not be removed and remained in the patient as a permanent device).|up to 12 months|129 patients received a filter. Filters were placed as permanent devices in 34 patients and as temporary devices in 95 patients. A decision to retrieve a filter was made by the physician once the patient’s medical condition warranted it (once the fliter was no longer required). Filter retrieval was attempted in 58 of 95 patients.||successful retrievals|||Number
740362|NCT00470626|Primary|Major Adverse Event|Composite Major Adverse Event includes hemorrhage, perforation, pulmonary embolism, procedure-related or device-related death, occlusion, significant migration and filter fracture.|up to 12 months|||participants|||Number
740363|NCT00470834|Secondary|Number of Participants With Metastatic Disease|Metastatic disease is that evidenced by a radiographic assessment. The time of metastatic disease was the date of radiographic evidence.|Interval of time between the date of the start of treatment and the date of radiographic evidence of metastatic disease (up to Study Month 42)|ITT Population||participants|||Number
740364|NCT00470834|Secondary|Change From Baseline in Total PSA at Months 6, 12, 18, 21, and 42|Change from Baseline in total PSA was measured at each scheduled post-baseline visit using a general linear model with effects for treatment and Baseline total PSA. Analysis was done using the last observation carried forward (LOCF) approach, in which missing post-Baseline values were imputed with earlier non-missing values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Months 6, 12, 18, 21, and 42|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Nanograms per milliliter (ng/mL)||Full Range|Median
740365|NCT00470834|Secondary|Number of Participants With PSA Response|PSA response is defined as a 50% or greater decrease in PSA from Baseline, confirmed by a second PSA measurement. The time of this response was the date of the first PSA measurement that showed a 50% or greater decrease from the Baseline PSA measurement. PSA confirmation was not required if no subsequent PSA values were available.|Time from Baseline PSA measurement until the first PSA measurement with a 50% or greater reduction in PSA values (up to Study Month 42)|ITT Population||participants|||Number
740366|NCT00470834|Secondary|Time to Treatment Failure|Time to treatment failure is defined as the interval of time between the date of the start of treatment and the date of treatment failure. Treatment failure is defined as PSA progression from Baseline (PSA value is 25% and at least 2 ng/mL above Baseline, confirmed by a second PSA value); metastatic disease (radiographic evidence of metastatic disease); death due to prostate cancer; or receipt of post-baseline rescue medications. PSA confirmation was not required if no subsequent PSA values were available. Participants who did not experience an event were censored at the date of the latest follow-up information.|Interval of time between the date of the start of treatment and the date of treatment failure (up to Study Month 42)|ITT Population. Data were not summarized for censored participants (no treatment failure).||Days||Standard Deviation|Mean
740367|NCT00470834|Primary|Time to Disease Progression|Time to disease progression (PD) is defined as the interval of time between the date of the start of treatment and the date of PD. PD is defined as prostate specific antigen (PSA) progression from Baseline (PSA value is 25% and at least 2 nanograms per milliliter [ng/mL] above Baseline, confirmed by a second PSA value); PSA progression from nadir, without a 50% decrease from Baseline (PSA value is 25% and at least 2 ng/mL above nadir, confirmed by a second PSA value); PSA progression from nadir, with a 50% or more decrease from Baseline (PSA value is 50% and at least 2 ng/mL above nadir, confirmed by a second PSA value); metastatic disease (radiographic evidence of metastatic disease); death due to prostate cancer; or the receipt of post-Baseline rescue medication. PSA confirmation was not required if no subsequent PSA values were available. Participants who did not experience an event were censored at the date of the latest follow-up information.|Interval of time between the date of the start of treatment and the date of disease progression (up to Study Month 42)|Intent-to-Treat (ITT) Population: all participants randomized to study treatment. Data were not summarized for censored participants (no disease progression).||Days||Standard Deviation|Mean
740368|NCT00470847|Secondary|Overall Survival|Overall average length of participant survival after protocol initiation|Participants were followed for an average of 3.8 years|||Months||Full Range|Median
740369|NCT00470847|Secondary|Percentage of Participants Having Non-Central Nervous System Sites as the Site of First Progression||5 years|||percentage of participants|||Number
740370|NCT00470847|Secondary|Percentage of Participants Having Central Nervous System as the Site of the First Progression||5 years|||percentage of participants|||Number
740371|NCT00470847|Secondary|Objective Response Rate in Central Nervous System Sites|Objective Response Rate was defined using volumetric response as the following: Complete Response (CR) is the disappearance of all target lesions, stable/responsive non-target lesions, and no new lesions. Partial response (PR) is at least a 50% reduction in the sum of the target lesions, stable/responsive non-target lesions, and no new lesions. Stable Disease (SD) is neither CR PR or Progressive Disease (PD). And Progressive Disease (PD) is at least 40% increase in sum of target lesionsor the appearance of any new lesion >=6mm in the longest dimension. If a patient progressed in a non-central nervous system(CNS) site first, died, or withdrew from the study for any reason after the first dose of drug was administered, and before a CR or PR in the central nervous system was determined, she was considered a CNS non-responder.|5 years|28 participants had measurable disease out of the 35 participants enrolled.||percentage of participants||95% Confidence Interval|Number
740372|NCT00470847|Secondary|Progression Free Survival|Progression Free Survival is the time from date of start of treatment to the date of the first documented progression or death due to any cause. If a patient has not progressed or died, progression free survival is censored at the time of last tumor assessment. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as a 20 % increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|5 years|||months||Full Range|Median
740373|NCT00470847|Primary|The Maximum Tolerated Dose of Lapatinib When Combined With Cranial Radiation in Patients With CNS Metastases From HER2-positive Breast Cancer.|The maximum tolerated dose is defined as :The highest dose of a drug or treatment that does not cause unacceptable side effects.|5 Years|||milligrams|||Number
740374|NCT00471068|Primary|Intaocular Pressure (IOP) Mean Change After 6 Weeks of Treatment|IOP measured at week 6 minus IOP measured at baseline|At week 0 and week 6|||millimeters mercury (mm Hg)||Standard Deviation|Mean
740375|NCT00471107|Primary|Verbal Memory|The Wechsler Memory Scale (WMS-III) is a neuropsychological test designed to measure different memory functions. The WMS-III Word Lists is a measure of verbal learning ability. The examiner reads a list of 12 semantically unrelated words and the subject immediately recalls as many words as possible. For this study, the primary outcome is a measure of verbal recall performance at 24 hours following presentation of the words under three conditions, i.e., anodal tDCS, cathodal tDCS, and sham. Scores may range from 0 (no words recalled) to 12 (all words recalled).|24 hours|All subjects in this group for whom data were obtained were analyzed||Words recalled||Standard Deviation|Mean
740376|NCT00471146|Secondary|Population Pharmacokinetic (PK) Analysis for Axitinib (AG-013736)|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Day 1 (pre-dose), Day 29, Day 57 and then every 8 weeks up to 23 months||||||
740377|NCT00471146|Secondary|Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) VAS Score|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.|Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal|ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.||Millimeter (mm)||Standard Deviation|Mean
740378|NCT00471146|Secondary|Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) Health State Profile|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal|ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.||Units on a scale||Standard Deviation|Mean
740379|NCT00471146|Secondary|Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score|BPI-sf is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions. BPI-sf are 4 questions that assess pain intensity (worst, least, average, right now) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each question is answered on a scale ranging from 0 to 10; ‘0=No pain and 10=Pain as bad as you can imagine’. Measure can be scored by item, with lower scores being indicative of less pain or pain interference.|Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal|ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.||Units on a scale||Standard Deviation|Mean
740380|NCT00471146|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score|QLQ-PAN26 consists of 26 questions (Qs) relating to disease symptoms, treatment (Tx) side effects and emotional issues specific to pancreatic cancer (PC). Questions include on altered bowel habits, pain, dietary changes, disease and Tx-related symptoms and issues related to the emotional and social well-being of participants with PC. All 26 Qs are answered on 4-point Likert scale ranging from ‘1=not at all’ to 4=’very much’ and subsequently transformed into scales that range from 0-100; higher scores= greater degree of symptoms or treatment side effects and emotional issues.|Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal|ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.||Units on a scale||Standard Deviation|Mean
740381|NCT00471146|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status (GHS), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4- point scale (1 ‘Not at All’ to 4 ‘Very Much’); 2 questions used 7-point scale (1 ‘Very Poor’ to 7 ‘Excellent’). Scores averaged, transformed to 0- 100 scale; higher score=better level of functioning or greater degree of symptoms. Change from baseline=Cycle/Day score minus baseline score.|Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal|ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.||Units on a scale||Standard Deviation|Mean
740391|NCT00471237|Secondary|Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)|Blood samples were collected at Baseline (Day 0), Week 4, Month 3, 6, and 12 for measurement of P1NP.|Baseline (Day 0), Week 4, Month 3, 6, and 12|Intent to treat population. Only those participants available at the specified time points were analyzed.||Microgram per Litre (mcg/L)||Standard Error|Least Squares Mean
740382|NCT00471146|Secondary|Duration of Response (DR)|Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7.|Baseline until death or at least 1 year after the randomization of last participant|DR was calculated for the subgroup of participants from the ITT population, with a confirmed objective tumor response (CR or PR).||Weeks||95% Confidence Interval|Median
740383|NCT00471146|Secondary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.|Baseline, every 8 weeks until tumor progression or death|ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.||Percentage of participants||95% Confidence Interval|Number
740384|NCT00471146|Secondary|Progression Free Survival (PFS)|"Time in weeks from randomization to the first documentation of objective tumor progression or death due to any cause. PFS was calculated as = (first event date minus randomization date plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Baseline until disease progression or at least 1 year after the randomization of last participant|ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.||Weeks||95% Confidence Interval|Median
740385|NCT00471146|Primary|Overall Survival (OS)|Time in weeks from randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Baseline until death or at least 1 year after the randomization of last participant|Intent-to-treat (ITT) population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.||Weeks||95% Confidence Interval|Median
740386|NCT00471237|Secondary|Time Required to Achieve Maximum Concentration of Ronacaleret in Blood (Tmax)|Blood samples were collected and analyzed for concentrations of ronacaleret. The individual blood concentration-time data from the intensive pharmacokinetic and pharmacodynamics subgroup of participants were analyzed by standard noncompartmental methods.|Pre-dose (0.0 h) and 12 h post dose at Week 4, 20, 40 min, 1, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 1-4, 8-12, and 24 h at Month 3, 6 and 12|Pharmacokinetic parameters population. Only those participants available at the specified time points were analyzed.||h||Full Range|Median
740387|NCT00471237|Secondary|Maximum Blood Concentration (Cmax) of Ronacaleret|Blood samples were collected and analyzed for concentrations of ronacaleret. The individual blood concentration-time data from the intensive pharmacokinetic and pharmacodynamics subgroup of participants were analyzed by standard noncompartmental methods. Blood samples were collected and analyzed for concentrations of ronacaleret. The individual blood concentration-time data from the intensive PK-PD subgroup of participants were analyzed by standard noncompartmental methods. Following log transformation, Cmax of ronacaleret were separately analyzed by ANOVA using mixed effects model, fitting treatment and country/region as fixed effects.|Pre-dose (0.0 h) and 12 h post dose at Week 4, 20, 40 min, 1, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 1-4, 8-12, and 24 h at Month 3, 6 and 12|Pharmacokinetic parameter population.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
740388|NCT00471237|Secondary|Area Under the Concentration-time Curve Over the Dosing Interval (AUC 0-t) and Area Under the Concentration-time Curve Over the Dosing Interval (AUC 0-tau) of Ronacaleret|Blood samples were collected and analyzed for concentrations of ronacaleret. The individual blood concentration-time data from the intensive pharmacokinetic and pharmacodynamics subgroup of participants were analyzed by standard noncompartmental methods. Blood samples were collected and analyzed for concentrations of ronacaleret. The individual blood concentration-time data from the intensive PK-PD subgroup of participants were analyzed by standard noncompartmental methods. Following log transformation, AUC(0-t) and AUC(0-τ) of ronacaleret were separately analyzed by ANOVA using mixed effects model, fitting treatment and country/region as fixed effects.|Pre-dose (0.0 h) and 12 h post dose at Week 4, 20, 40 min, 1, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 1-4, 8-12, and 24 h at Month 3, 6 and 12|Pharmacokinetic Parameters Population comprised of any participant in the pharmacokinetic concentration population who provided pharmacokinetic parameters. Only those participants available at the specified time points were analyzed.||nanogram*hour per millilitre (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
740389|NCT00471237|Secondary|Blood Concentrations of Ronacaleret|Blood samples were collected and analyzed for concentrations of ronacaleret. The individual blood concentration-time data from the intensive PK-PD subgroup of participants were analyzed by standard noncompartmental methods. Blood concentrations of ronacaleret were reported.|Pre-dose (0.0 hour [h]) and 12 h post dose at Week 4, 20, 40 min, 1, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 1-4, 8-12, and 24 h at Month 3, 6 and 12|Pharmacokinetic Concentration Population comprised of any Intent-to-Treat participants for whom a SB-751689 pharmacokinetic blood sample was obtained and analyzed. Only those participants available at the specified time points were analyzed.||nanograms per millilitre (ng/mL)||Standard Deviation|Mean
740390|NCT00471237|Secondary|Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)|Blood samples were collected at Baseline (Day 0), Week 4, Month 3, 6, and 12 for measurement of BALP.|Baseline (Day 0), Week 4, Month 3, 6, and 12|Intent-to-Treat population. Only those participants available at the specified time points were analyzed.||mcg/L||Standard Error|Least Squares Mean
740608|NCT00460525|Secondary|Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by ELISA at Day 90.|Titers of Anti-FMP2.1 antibody were determined by ELISA from sera collected at Day 90.|Day 90 after initial vaccination|Analyses are ITT. No imputation techniques were used.||Titer||95% Confidence Interval|Geometric Mean
740392|NCT00471237|Secondary|Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)|Blood samples were collected at Baseline (Day 0), Week 4, Month 3, 6, and 12 for measurement of CTX1.|Baseline (Day 0), Week 4, Month 3, 6, and 12|Intent-to-Treat population. Only those participants available at the specified time points were analyzed.||nanogram per litre (ng/L)||Standard Error|Least Squares Mean
740393|NCT00471237|Secondary|Percent Change From Baseline to Month 12 in Cortical Thickness at the Hip as Measured by QCT Scans.|Percent change in thickness of femur neck cortical VOI thickness and trochanter cortical VOI thickness were at Month 12 measured by QCT were reported. Assessments performed on Day 0 were considered as Baseline. Percent change from Baseline was computed as (change from baseline / baseline value) * 100%.|Baseline (Day 0) and Month 12|Intent-to-Treat population. Only those participants available at the specified time points were analyzed.||millimeter (mm)||Standard Deviation|Mean
740394|NCT00471237|Secondary|Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans|QCT is a three-dimensional non-projectional technique to quantify BMD with a number of advantages to other densitometric techniques. Cortical and trabecular bone can be separated, trabecular VOI are largely independent of degenerative changes in the spine and 3 dimensional geometric parameters can be determined. BMD as measured by QCT is a true density measured in mg/cm^3 in contrast to DXA Which determines an areal density measured in g/cm^2. Baseline values were assessed on Day 0. Percent change from Baseline was computed as (change from baseline / baseline value) * 100%.|Baseline (Day 0) and Month 12|Intent-to-Treat population. Only those participants available at the specified time points were analyzed.||mg/cm^3||Standard Deviation|Mean
740395|NCT00471237|Secondary|Percent Change From Baseline to Month 12 in the Total Vertebra Integral VOI at the Lumbar Spine as Measured by QCT Scans|QCT is a three-dimensional non-projectional technique to quantify BMD with a number of advantages to other densitometric techniques. Cortical and trabecular bone can be separated, trabecular VOI are largely independent of degenerative changes in the spine and 3 dimensional geometric parameters can be determined. BMD as measured by QCT is a true density measured in g/cm^3 in contrast to DXA Which determines an areal density measured in g/cm^2. Baseline values were assessed on Day 0. Percent change from Baseline was computed as (change from baseline / baseline value) * 100%.|Baseline (Day 0) and Month 12|Intent-to-Treat population. Only those participants available at the specified time points were analyzed.||gm/cm^2||Standard Deviation|Mean
740396|NCT00471237|Secondary|Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip and Lumbar Spine as Measured by Quantitative Computer Tomography (QCT) Scans|QCT is a three-dimensional non-projectional technique to quantify BMD with a number of advantages to other densitometric techniques. Cortical and trabecular bone can be separated, trabecular volume of interest (VOI) are largely independent of degenerative changes in the spine and 3 dimensional geometric parameters can be determined. BMD as measured by QCT is a true density measured in g/cm^3 in contrast to DXA Which determines an areal density measured in g/cm^2. Baseline values were assessed on Day 0. Percent change from Baseline was computed as (change from baseline / baseline value) * 100%. Percent change from Baseline to month 12 in the volumetric integral, cortical, and trabecular density (BMD) at the hip and lumbar spine measured by QCT were reported.|Baseline (Day 0) and Month 12|Intent-to-Treat population. Only those participants available at the specified time points were analyzed.||mg/cubic centimeter (mg/cm^3)||Standard Deviation|Mean
740397|NCT00471237|Secondary|Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)|Responder rate of participants who remained the same or had any improvement as compared to baseline in DXA BMD of vertebra, femur and vertebra plus femur were reported. Baseline values were assessed on Day 0. Percent change (improvement) from Baseline was computed as (change from baseline / baseline value) * 100%.|Baseline (Day 0), Month 5, 6 and 12|Intent-to-Treat population. Only those participants available at the specified time points were analyzed.||Participants|||Count of Participants
740398|NCT00471237|Secondary|Change From Baseline to Months 6 and 12 in BMD Measured by DXA Scans of the Hip (Total Hip, Femoral Neck and Trochanter).|DXA scanners from Hologic and GE Lunar was used to measure BMD by a DXA scan. At least two vertebrae (L1-L4) that were suitable for measurement of BMD were evaluated. The same scanner was used throughout the study for all measurements for a given participant. DXA scans were sent to a central reading facility for quality control and central analysis. Baseline values were assessed on Day 0. Percent Change from Baseline was computed as (change from baseline / baseline value) * 100%. Percent change from baseline to month 6 and 12 in aBMD of hip (total hip, femoral neck and trochanter) were reported.|Baseline (Day 0), Month 6 and Month 12|Intent-to-Treat population. Only those participants available at the specified time points were analyzed.||mg/square centimeter (cm^2)||Standard Error|Least Squares Mean
740399|NCT00471237|Secondary|Percent Change From Baseline to Month 6 in BMD Measured by DXA Scans of the Lumbar Spine (L1-L4)|DXA scanners from Hologic and GE Lunar was used to measure BMD by a DXA scan. At least two vertebrae (L1-L4) that were suitable for measurement of BMD were evaluated. The same scanner was used throughout the study for all measurements for a given participant. DXA scans were sent to a central reading facility for quality control and central analysis. Baseline values were assessed on Day 0. Percent Change from Baseline was computed as (change from baseline / baseline value) * 100%. Percent change from baseline to month 6 in aBMD was reported.|Baseline (Day 0) and Month 6|Intent to Treat Population. Only those participants available at the specified time point were analyzed.||percent change in BMD||Standard Error|Least Squares Mean
740400|NCT00471237|Primary|Mean Change From Baseline in Weight|Baseline values were assessed on Day 0. Change from Baseline was computed as values at post baseline visit minus Baseline value. Mean change from baseline in weight at Month 6, 12 and early withdrawal were reported.|Baseline (Day 0), Month 6, 12 and early withdrawal|Intent-to-Treat population. Only those participants available at the specified time points were analyzed.||Kilogram||Standard Deviation|Mean
740401|NCT00471237|Primary|Mean Change From Baseline in Height|Assessments performed on Day 0 were considered as Baseline. Change from Baseline was computed as values at post baseline visit minus Baseline value. Mean change from baseline in height at Month 6 and 12 and early withdrawal were reported.|Baseline (Day 0), Month 6, 12 and early withdrawal|Intent-to-Treat population. Only those participants available at the specified time points were analyzed.||Centimeter||Standard Deviation|Mean
740402|NCT00471237|Primary|Number of Participant With Electrocardiogram (ECG) Findings Reported as Adverse Event|Full 12-lead ECGs pre-dose at screening and visits 6, 8, 11, 12 and 14 were recorded. Participants rested supine or seated for at least 10 minutes before each reading. All ECGs were transmitted to a central reviewer for blinded assessment. The central reviewer measured the following parameters and provide a clinical interpretation: heart rate, RR interval, PR interval, QRS interval, QT (uncorrected) interval, QTcB (Bazett’s correction) interval, QTcF (Fridericia’s correction) interval. The central reviewer was provided the investigator or designated qualified site physician with a central ECG report or confirmatory report to assist them in identifying any clinically significant abnormalities that would preclude the participant from further participation in the study.|Up to 12 months|Intent-to-Treat population.||Participants|||Count of Participants
740403|NCT00471237|Primary|Number of Participant With Vital Signs of Potential Clinical Concern at Any Post-baseline Visit|The potential clinical importance ranges (low and high) of the vital sign parameters-systolic blood pressure (> 30 millimeter of mercury [mmHg] decrease from Baseline, > 30 mmHg increase from Baseline), diastolic blood pressure (> 20 mmHg decrease from Baseline and > 20 mmHg increase from Baseline) and heart rate (<45 and >120 beats per minute). Only those parameters for which at least one value of potential clinical importance was reported are summarized. The number of participants with potential clinical important vital parameter findings at any visit were reported.|Up to 12 Months|Intent-to-Treat population.||Participants|||Count of Participants
740404|NCT00471237|Primary|Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit|The hematology parameters analyzed were white blood cells (WBC) count with differential WBC count, red blood cells, haemoglobin, haematocrit, mean corpuscular volume and platelet count. The clinical chemistry parameters analyzed were sodium, potassium, calcium, calcium (albumin adjusted), phosphate, bicarbonate, creatinine, bilirubin (total), alanine amino transferase, aspartate amino transferase, glucose, albumin, alkaline phosphatase, creatine phosphokinase, urea, uric acid, total protein, 25-OH vitamin D, 1,25-2(OH) vitamin D, whole parathyroid hormone (PTH 1-84)) and intact PTH (1-84 and 7-84). Only those parameters for which at least one value of potential clinical importance was reported are summarized. The number of participants with potential clinical important laboratory findings at any visit were reported.|Up to Month 12|Intent-to-Treat population.||Participants|||Count of Participants
740405|NCT00471237|Primary|Number of Participants Withdrew Due to Hypercalcemia|A confirmed albumin-adjusted serum calcium pre-dose value of >11.0 mg/dL or post-dose value of >12.0 mg/dL was set as a withdrawal criteria for the study. Number of participants who met this pre-defined stopping criteria were reported.|Up to Month 12|Intent-to-Treat population.||Participants|||Count of Participants
740406|NCT00471237|Primary|Number of Participants With Hypercalcemia|Participants with albumin-adjusted serum calcium pre-dose values of >11.0 mg/ deciliter (dL) or post-dose values of >12.0 mg/dL were recorded as participants with hypercalcemia. Number of participant with hypercalcemia were reported.|Up to Month 12|Intent-to-Treat population.||Participants|||Count of Participants
740407|NCT00471237|Primary|Percent Change From Baseline in Bone Marrow Density (BMD) at Month 12 Measured by Dual-Energy X-Ray Absorptiometry (DXA) Scans of the Lumbar Spine (L1-L4)|DXA scanners from Hologic and GE Lunar was used to measure BMD by a DXA scan. At least two vertebrae (L1-L4) that were suitable for measurement of BMD were evaluated. The same scanner was used throughout the study for all measurements for a given participant. DXA scans were sent to a central reading facility for quality control and central analysis. Assessments performed on Day 0 were considered as Baseline. Percent change from Baseline was computed as (change from baseline / baseline value) * 100%. Percent change from Baseline in areal bone mineral density (aBMD) was reported.|Baseline (Day 0) and 12 Months|Intent-to-Treat population comprised of any randomised or teriparatide participant who received at least one dose of study medication. Only those participants available at the specified time points were analyzed.||Percent change in BMD||Standard Error|Least Squares Mean
740408|NCT00471276|Other Pre-specified|1-Year Survival Probability|Probability of survival 1 year after the first dose of study treatment.|Baseline up to 1 year|ITT||Percentage of participants||95% Confidence Interval|Number
740409|NCT00471276|Secondary|Change From Baseline in CTSQ Score: Satisfaction With Therapy|CTSQ: included 3 multi-item subscales (Expectation of Therapy [ET], Satisfaction with Therapy [SWT], and Feelings about Side Effects [FSE]). Questions used 5-point scale from 1 'Never' to 5 'Always'. Scores averaged and transformed to 0-100 scale, with higher scores associated with better outcomes. Change from baseline=score for Cycle/Day minus baseline score.|Baseline, Day 15, Week 4 and 8, and every 8 weeks up to Month 36 or early termination|ITT; N=participants with baseline CTSQ data and data on any cycle/day; n=participants with baseline CTSQ data and data at corresponding cycle/day. Cycle 1 Day 15 measurements only for subset of participants with loco-regional superficial disease. Results reported for Cycles 1, 2, 3, 5 and 7 only, because (n) decreased substantially after Cycle 7.||Units on a scale||Full Range|Median
740410|NCT00471276|Secondary|Change From Baseline in CTSQ Score: Feelings About Side Effects|CTSQ: included 3 multi-item subscales (Expectation of Therapy [ET], Satisfaction with Therapy [SWT], and Feelings about Side Effects [FSE]). Questions used 5-point scale from 1 'Never' to 5 'Always'. Scores averaged and transformed to 0-100 scale, with higher scores associated with better outcomes. Change from baseline=score for Cycle/Day minus baseline score.|Baseline, Day 15, Week 4 and 8, and every 8 weeks up to Month 36 or early termination|ITT; N=participants with baseline CTSQ data and data on any cycle/day; n=participants with baseline CTSQ data and data at corresponding cycle/day. Cycle 1 Day 15 measurements only for subset of participants with loco-regional superficial disease. Results reported for Cycles 1, 2, 3, 5 and 7 only, because (n) decreased substantially after Cycle 7.||Units on a scale||Full Range|Median
740411|NCT00471276|Secondary|Change From Baseline in Cancer Therapy Satisfaction Questionnaire (CTSQ) Score: Expectation of Therapy|CTSQ: included 3 multi-item subscales (Expectation of Therapy [ET], Satisfaction with Therapy [SWT], and Feelings about Side Effects [FSE]). Questions used 5-point scale from 1 'Never' to 5 'Always'. Scores averaged and transformed to 0-100 scale, with higher scores associated with better outcomes. Change from baseline=score for Cycle/Day minus baseline score.|Baseline, Day 15, Week 4 and 8, and every 8 weeks up to Month 36 or early termination|ITT; N=participants with baseline CTSQ data and data on any cycle/day; n=participants with baseline CTSQ data and data at corresponding cycle/day. Cycle 1 Day 15 measurements only for subset of participants with loco-regional superficial disease. Results reported for Cycles 1, 2, 3, 5 and 7 only, because (n) decreased substantially after Cycle 7.||Units on a scale||Full Range|Median
740412|NCT00471276|Secondary|Change From Baseline in EORTC-QLQ-BR23 Score: Upset by Hair Loss|EORTC-QLQ-BR23: included functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions used 4-point Likert scale (1 ‘Not at All’ to 4 ‘Very Much’). Scores averaged and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems. Change from baseline=Cycle/Day score minus baseline score.|Baseline, every 4 weeks up to Month 31 or early termination|ITT; N=participants who completed the scales at both baseline and any cycle; n=number of participants who completed the scales at both baseline and the respective cycle. Results reported for Cycles 1 through 6 only, because (n) decreased substantially after Cycle 6.||Units on a scale||Full Range|Median
740413|NCT00471276|Secondary|Change From Baseline in EORTC-QLQ-BR23 Score: Systemic Therapy Side Effects|EORTC-QLQ-BR23: included functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions used 4-point Likert scale (1 ‘Not at All’ to 4 ‘Very Much’). Scores averaged and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems. Change from baseline=Cycle/Day score minus baseline score.|Baseline, every 4 weeks up to Month 31 or early termination|ITT; N=participants who completed the scales at both baseline and any cycle; n=number of participants who completed the scales at both baseline and the respective cycle. Results reported for Cycles 1 through 6 only, because (n) decreased substantially after Cycle 6.||Units on a scale||Full Range|Median
740414|NCT00471276|Secondary|Change From Baseline in EORTC-QLQ-BR23 Score: Breast Symptoms|EORTC-QLQ-BR23: included functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions used 4-point Likert scale (1 ‘Not at All’ to 4 ‘Very Much’). Scores averaged and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems. Change from baseline=Cycle/Day score minus baseline score.|Baseline, every 4 weeks up to Month 31 or early termination|ITT; N=participants who completed the scales at both baseline and any cycle; n=number of participants who completed the scales at both baseline and the respective cycle. Results reported for Cycles 1 through 6 only, because (n) decreased substantially after Cycle 6.||Units on a scale||Full Range|Median
740415|NCT00471276|Secondary|Change From Baseline in EORTC-QLQ-BR23 Score: Arm Symptoms|EORTC-QLQ-BR23: included functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions used 4-point Likert scale (1 ‘Not at All’ to 4 ‘Very Much’). Scores averaged and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems. Change from baseline=Cycle/Day score minus baseline score.|Baseline, every 4 weeks up to Month 31 or early termination|ITT; N=participants who completed the scales at both baseline and any cycle; n=number of participants who completed the scales at both baseline and the respective cycle. Results reported for Cycles 1 through 6 only, because (n) decreased substantially after Cycle 6.||Units on a scale||Full Range|Median
740416|NCT00471276|Secondary|Change From Baseline in EORTC-QLQ-BR23 Score: Sexual Functioning|EORTC-QLQ-BR23: included functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions used 4-point Likert scale (1 ‘Not at All’ to 4 ‘Very Much’). Scores averaged and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems. Change from baseline=Cycle/Day score minus baseline score.|Baseline, every 4 weeks up to Month 31 or early termination|ITT; N=participants who completed the scales at both baseline and any cycle; n=number of participants who completed the scales at both baseline and the respective cycle. Results reported for Cycles 1 through 6 only, because (n) decreased substantially after Cycle 6.||Units on a scale||Full Range|Median
740417|NCT00471276|Secondary|Change From Baseline in EORTC-QLQ-BR23 Score: Sexual Enjoyment|EORTC-QLQ-BR23: included functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions used 4-point Likert scale (1 ‘Not at All’ to 4 ‘Very Much’). Scores averaged and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems. Change from baseline=Cycle/Day score minus baseline score.|Baseline, every 4 weeks up to Month 31 or early termination|ITT; N=participants who completed the scales at both baseline and any cycle; n=number of participants who completed the scales at both baseline and the respective cycle. Results reported for Cycles 1 through 6 only, because (n) decreased substantially after Cycle 6.||Units on a scale||Full Range|Median
740418|NCT00471276|Secondary|Change From Baseline in EORTC-QLQ-BR23 Score: Future Perspective|EORTC-QLQ-BR23: included functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions used 4-point Likert scale (1 ‘Not at All’ to 4 ‘Very Much’). Scores averaged and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems. Change from baseline=Cycle/Day score minus baseline score.|Baseline, every 4 weeks up to Month 31 or early termination|ITT; N=participants who completed the scales at both baseline and any cycle; n=number of participants who completed the scales at both baseline and the respective cycle. Results reported for Cycles 1 through 6 only, because (n) decreased substantially after Cycle 6.||Units on a scale||Full Range|Median
740441|NCT00471354|Secondary|Change From Baseline to 24 Week Endpoint in Clinical Global Impressions - Attention-Deficit/Hyperactivity Disorder - Severity Scale (CGI-ADHD-S)|Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).|Baseline, 24 weeks|All patients with baseline and at least one non-missing post-baseline score for each of the variables. Last observation carried forward.||units on a scale||Standard Deviation|Mean
740419|NCT00471276|Secondary|Change From Baseline in EORTC-QLQ Companion Breast Cancer Module (EORTC-QLQ-BR23) Score: Body Image|EORTC-QLQ-BR23: included functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions used 4-point Likert scale (1 ‘Not at All’ to 4 ‘Very Much’). Scores averaged and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems. Change from baseline=Cycle/Day score minus baseline score.|Baseline, every 4 weeks up to Month 31 or early termination|ITT; N=participants who completed the scales at both baseline and any cycle; n=number of participants who completed the scales at both baseline and the respective cycle. Results reported for Cycles 1 through 6 only, because (n) decreased substantially after Cycle 6.||Units on a scale||Full Range|Median
740420|NCT00471276|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionaire-C30 (EORTC- QLQ-C30) Score|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4-point scale (1 ‘Not at All’ to 4 ‘Very Much’); 2 questions used 7-point scale (1 ‘Very Poor’ to 7 ‘Excellent’). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms. Change from baseline=Cycle/Day score minus baseline score.|Baseline, every 4 weeks up to Month 31 or early termination|ITT; N=participants who completed the scales at both baseline and any cycle; n=number of participants who completed the scales at both baseline and the respective cycle. Results reported for Cycles 1 through 6 only, because (n) decreased substantially after Cycle 6.||Units on a scale||Full Range|Median
740421|NCT00471276|Secondary|Number of Participants With Objective Response for Subgroup of Participants Whom Sunitinib Was at Least a Third Line Therapy|Number of participants with objective response based assessment of confirmed CR or PR according to RECIST. CR defined as disappearance of all target lesions. PR defined as ≥30% decrease in sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Baseline, Week 9, and every 8 weeks up to Month 34|ITT; N=participants who received at least 2 lines of prior chemotherapy for advanced/metastatic disease and had post baseline tumor assessment||Participants|||Number
740422|NCT00471276|Secondary|Overall Survival (OS)|Time from randomization to date of death due to any cause. OS (Months)=(death date minus date of first dose of study medication plus 1) divided by 30.4. For participants who were alive, overall survival was censored at last contact.|Baseline until death (up to Month 34)|ITT||Months||95% Confidence Interval|Median
740423|NCT00471276|Secondary|Duration of Response (DR)|Time from first objective documentation of complete or partial response that was subsequently confirmed to first documentation of disease progression or death due to any cause, whichever occurred first. DR calculated as (Weeks)=(end date for DR minus first subsequent confirmed CR or PR plus 1) divided by 7.|Baseline up to Month 34 or early termination|ITT; N=participants with objective response||Weeks||Full Range|Median
740424|NCT00471276|Secondary|Progression-Free Survival (PFS)|Time from date of randomization to date of first documentation of objective tumor progression or death due to any cause, whichever occurred first. PFS calculated as (Months)=(first event date minus randomization date plus 1) divided by 30.4.|Baseline up to Month 34|ITT||Months||95% Confidence Interval|Median
740425|NCT00471276|Secondary|Number of Participants With Objective Response of Superficial Lesions|Number of participants with objective response based assessment of confirmed CR or PR of superficial lesions according to RECIST. Superficial lesions included skin lesions, chest wall lesions, and breast lesions and lymph nodes if followed up by physical examination.|Baseline, every 4 weeks up to Month 34|ITT; Number of participants analyzed equaled (N =) participants who had superficial lesions with post baseline follow-up assessments of those lesions.||Participants|||Number
740426|NCT00471276|Secondary|Number of Participants With Clinical Benefit|The sum of participants with confirmed CR, PR, and stable disease (SD) greater than (>) 6 months according to RECIST. SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference smallest sum of longest dimensions since treatment started.|Baseline, Week 9, and every 8 weeks up to Month 34|ITT||Participants|||Number
740427|NCT00471276|Primary|Number of Participants With Objective Response|Number of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as disappearance of all target lesions. PR defined as a greater than or equal to 30 percent (≥30%) decrease in sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Baseline, Week 9, and every 8 weeks up to Month 34|Intent to Treat (ITT) population: all enrolled participants||Participants|||Number
740428|NCT00471315|Primary|The Primary Outcome Measure Was a Patient Global Assessment of Change (PGIC) Scale.|The primary outcome measure was a Patient Global Assessment of Change (PGIC) scale which reports the patient's overall view of any changes in their overall status since their sphincterotomy treatment. (1=Very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse). Success was defined as 3-month PGIC score of much or very much improved (PGIC of either 1 or 2). Patients missing the 3 month visit were considered failures for the primary outcome.|3 months|||units on a scale||Standard Deviation|Mean
740429|NCT00471315|Secondary|Toleration of the Medication as Measured by the Duloxetine Compliance Rate|The secondary outcome measure of the study was number of patients who remained on Duloxetine at the completion of the study.|3 Months|||participants|||Number
740430|NCT00471328|Secondary|Overall Clinical Benefit (Complete Response [CR]/Partial Response [PR] or Stable Disease [SD]) From Local Investigator's Assessment Based on Treatment Crossover Analysis Set|The overall clinical benefit includes the best overall responses of CR, PR, or SD. The best overall responses of CR/PR must be confirmed by at least two determinations at least 4 weeks apart before progression. The best overall response of SD must have at least one SD (or better) at least 6 weeks (or 6 months or 12 months as applicable) after randomization but before progression.|Up to 34 months|Treatment Crossover Analysis Set: All patients who crossed over from control arm to nilotinib after completing the Core study or during the Extension study after disease progression.||Percentage of Participants||95% Confidence Interval|Number
740431|NCT00471328|Secondary|Overall Clinical Benefit (Complete Response [CR]/Partial Response [PR] or Stable Disease [SD]) From Central Radiology Review Based on Primary Analysis (Data Cut-off: June, 2008)|The overall clinical benefit includes the best overall responses of CR, PR, or SD. The best overall responses of CR/PR must be confirmed by at least two determinations at least 4 weeks apart before progression. The best overall response of SD must have at least one SD (or better) at least 6 weeks (or 6 months or 12 months as applicable) after randomization but before progression.|Up to 16 months|The intent to treat (ITT) population was defined as all randomized patients and was used as the primary efficacy population.||Percentage of Participants||95% Confidence Interval|Number
740432|NCT00471328|Secondary|Number of Responders With Confirmed Best Overall Response of Complete Response (CR) or Partial Response (PR) From Local Investigator's Assessment Based on Treatment Crossover Analysis Set|The best overall response (CR/PR) must be confirmed by at least two determinations at least 4 weeks apart before progression. Using modified RECIST criteria, a Complete Response is defined as disappearance of all lesions, and a Partial Response is defined as either 1) at least a 30% decrease in the sum of the longest diameter of target lesions and no new lesions or progression of non-target lesions or 2) disappearance of all target lesions but persistence of one or more non-target lesion(s).|Up to 34 months|Treatment Crossover Analysis Set: All patients who crossed over from control arm to nilotinib after completing the Core study or during the Extension study after disease progression.||Participants|||Number
740433|NCT00471328|Secondary|Number of Responders With Confirmed Best Overall Response of Complete Response (CR) or Partial Response (PR) From Central Radiology Review During Primary Analysis (Data Cut-off: June, 2008)|The best overall response is the best response recorded from randomization until disease progression. The CR/PR must be confirmed by at least two determinations at least 4 weeks apart before progression. Using modified RECIST criteria, a Complete Response is defined as disappearance of all lesions, and a Partial Response is defined as either 1) at least a 30% decrease in the sum of the longest diameter of target lesions and no new lesions or progression of non-target lesions or 2) disappearance of all target lesions but persistence of one or more non-target lesion(s).|Up to 16 months|The intent to treat (ITT) population was defined as all randomized patients and was used as the primary efficacy population.||Participants|||Number
740434|NCT00471328|Primary|Progression-free Survival (PFS) From Local Investigator’s Assessment Based on Treatment Crossover Analysis Set|PFS is defined as the time from the first date of cross-over to nilotinib therapy from the control arm to the date of the first observation of documented disease progression. Tumor assessment was based on the local investigator's measurement using Modified Response Evaluation Criteria in Solid Tumors (modified RECIST) criteria. Progression is defined according to modified RECIST criteria as at least a 20% increase in the sum of the longest diameter of target lesions, worsening of the non-target lesions or the appearance of one or more new lesions.|Up to 34 months|Treatment Crossover Analysis Set: All patients who crossed over from control arm to nilotinib after completing the Core study or during the Extension study after disease progression.||days||95% Confidence Interval|Median
740435|NCT00471328|Secondary|Overall Survival for Treatment Crossover Analysis Set|For patients who crossed-over to nilotinib from the control arm, the overall survival was the time from the first dose date of nilotinib after switching from control arm to the date of death due to any cause. If death was not observed, the OS was censored at the latest date the patient was known to be alive.|Up to 34 months|Treatment Crossover Analysis Set: All patients who crossed over from control arm to nilotinib after completing the Core study or during the Extension study after disease progression.||days||95% Confidence Interval|Median
740436|NCT00471328|Secondary|Overall Survival During Core and Extension Phases of the Study|Overall survival (OS) is defined as the time from date of randomization to date of death due to any cause. If a participant is not known to have died, survival will be censored at the date of last contact. This analysis included both Core and Extension data as well as survival follow up data.|Up to 50 months (including core, extension and follow up period)|Core Full Analysis Set (Core FAS): included all randomized patients included in the Core study. Analyses based on Core FAS does not account for treatment crossover i.e.pooling all data both before and after crossover. This analysis set was used to conduct an overall survival analysis.||days||95% Confidence Interval|Median
740437|NCT00471328|Secondary|Overall Survival Based on Primary Analysis (Data Cut-off:June, 2008)|Overall survival (OS) is defined as the time from date of randomization to date of death due to any cause. If a participant is not known to have died, survival will be censored at the date of last contact.|Up to 16 months|The intent to treat (ITT) population was defined as all randomized participants and was used as the primary efficacy population.||days||95% Confidence Interval|Median
740438|NCT00471328|Primary|Progression-free Survival (PFS) From Central Radiology Review Based on Primary Analysis (Data Cut-off: June, 2008)|Progression-free survival (PFS) is the time from date of randomization to the date of first documented progression or death due to any cause. If a participant has not had an event, progression-free survival is censored at the time of last adequate tumor assessment. Progression is defined according to Modified Response Evaluation Criteria in Solid Tumors (modified RECIST) criteria as at least a 20% increase in the sum of the longest diameter of target lesions, worsening of the non-target lesions or the appearance of one or more new lesions.|Up to 16 months|The intent to treat (ITT) population was defined as all randomized patients and was used as the primary efficacy population.||days||95% Confidence Interval|Median
740439|NCT00471354|Secondary|Change From Baseline to 24 Week Endpoint in Revised Conners' Parent Rating Scale: Short Form (CPRS-R:S) Attention-Deficit/Hyperactivity Disorder Index Score|A 27-item rating scale (0 [not at all/never] to 3 [very much true/very often]) completed by the parent to assess problem behaviors related to ADHD. Subscale assessed: ADHD Index. ADHD Index is the sum of items 1, 5, 7, 10, 13, 15, 17, 19, 21, 23, 25, and 27. Subscale total scores range from 0 to 36. Higher scores reflect more severe problem behaviors related to ADHD.|Baseline, 24 weeks|All patients with baseline and at least one non-missing post-baseline score for each of the variables. Last observation carried forward.||units on a scale||Standard Deviation|Mean
740440|NCT00471354|Secondary|CGI-ADHD-Improvement Scale (CGI-ADHD-I) at 24 Week Endpoint|Measures total improvement (or worsening) of a patient's ADHD symptoms from the beginning of treatment (1=very much improved, 7=very much worsened).|24 weeks|All patients with baseline and at least one non-missing post-baseline score for each of the variables. Last observation carried forward.||units on a scale||Standard Deviation|Mean
740442|NCT00471354|Secondary|Change From Baseline to 24 Week Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered and Scored - Total Score|Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54.|Baseline, 24 weeks|All patients with baseline and at least one non-missing post-baseline score for each of the variables. Last observation carried forward.||units on a scale||Standard Deviation|Mean
740443|NCT00471354|Secondary|Change From Baseline to 24 Week Endpoint in Academic Performance by School Grade Average (SGA) Total, and Separate Language, Math, and Science Scores|Separate school grades in the classes of Language, Math, and Science were obtained. A score between 0 and 100 was provided for each of the three classes, and the average taken to get a SGA Total Score between 0 and 100, with higher scores indicating better grades/apptitude in each class and overall. Any ordinal grades were imputed to numerical grades based on communication with relevant schools.|Baseline, 24 weeks|All patients with baseline and at least one non-missing post-baseline score for each of the variables. Last observation carried forward.||units on a scale||Standard Deviation|Mean
740444|NCT00471354|Secondary|Correlation Between Change From Baseline to 24 Week Endpoint in ADHDRS-IV-Parent:Inv Total Score and School Grade Averages in Separate Language, Math and Science Classes|Correlation was calculated between change from baseline and endpoint in ADHD-RS Total Score and change in separate SGA language, math, and science scores. ADHD-RS measures 18 symptoms associated with diagnosis of ADHD. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. SGA: separate language, math, and science school grades on a scale of 0-100, with higher scores indicating better grades/apptitude in the respective class. Any ordinal grades were imputed to numerical grades based on communication with relevant schools.|Baseline, 24 weeks|All patients with baseline and at least one non-missing post-baseline score for each of the variables, regardless of them having or not having received any ordinal grades (for the SGA).||Spearman Correlation Coefficient|||Number
740445|NCT00471354|Primary|Correlation Between Change From Baseline and 24 Week Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent:Investigator-Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score and School Grade Average (SGA)|Correlation was calculated between change from baseline and endpoint in ADHD-RS Total Score and change in SGA total score. ADHD-RS measures 18 symptoms associated with diagnosis of ADHD. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. SGA: Grades (0 to 100) in classes of Language, Math, and Science were obtained and average taken to get SGA Total Score between 0 and 100; higher scores indicating better grades/apptitude. Any ordinal grades were imputed to numerical grades based on communication with relevant schools.|Baseline, 24 weeks|All patients with baseline and at least one non-missing post-baseline score for each of the variables, regardless of them having or not having received any ordinal grades (for the SGA).||Spearman Correlation Coefficient|||Number
740446|NCT00471380|Primary|Intra Ocular Pressure (IOP)|Intra Ocular Pressure, calculated as AUC (area under the curve) of IOP measured from 8.00 a.m. to 8.00 p.m, at different time-points|Baseline, end of each period (week 8, week 16, week 24)|||mm Hg (millimeters mercury)*week||Standard Deviation|Mean
740447|NCT00471445|Primary|Change in Average Daily Peripheral Neuropathy Intensity Score From Baseline to Week 6 in Patients Treated With Amitriptyline and Ketamine Hydrochloride vs Placebo|"Cancer survivors who completed chemotherapy at least 1 month prior and had Chemotherapy Induced Peripheral Neuropathy (CIPN) (greater than or equal to 4 out of 10) were enrolled. CIPN was assessed using average scores from a 7-day daily diary that asks patients to rate the average pain, numbness, or tingling in their hands and feet over the past 24 hours on an 11-point numeric rating scale at baseline and 6 weeks post intervention. CIPN ranges from 0 (no pain) to 10 (worst possible pain)."|Week 6 - Baseline|||units on a scale||95% Confidence Interval|Mean
740448|NCT00471497|Secondary|Rate of Complete Cytogenetic Response (CCyR) in Nilotinib Treatment Arms With Imatinib at 12 Months||Baseline, 12 months||||||
740449|NCT00471497|Secondary|Rate Reduction in BCR-ABL Transcript Levels in Nilotinib Treatment Arms With Imatinib at 12 Months||Baseline, 12 months||||||
740450|NCT00471497|Secondary|Rate of Durable MMR at 24 Months.||Baseline, 24 months||||||
740451|NCT00471497|Primary|Molecular Response Rate (MMR) at 12 Months|Rate of MMR is defined as <= 0.1% BCR-ABL/ABL ratio by international scale (IS), measured by real-time quantitative polymerase chain reaction (RQ-PCR) which corresponds to a ≥ 3 log reduction of BCR-ABL transcript from standardized baseline. BCR-ABL = fusion gene from BCR (breakpoint cluster region gene/BCR gene product) and ABL (Abelson protooncogene)|Baseline, 12 months|Patients in the Full Analysis Set (FAS) were analyzed according to the treatment they were randomized to regardless of actual treatment received.||Percentage of participants||95% Confidence Interval|Number
740452|NCT00471536|Secondary|Survival Time|The distribution of survival times will be estimated using the Kaplan-Meier method.|Time from registration until death due to any cause, assessed every 6 months after PD for up to 2 years after registration|all participants were evaluable for this endpoint.||months||95% Confidence Interval|Median
740453|NCT00471536|Secondary|Time to Disease Progression|The distribution of progression-free survival times will be estimated using the Kaplan-Meier method.|Every 3 months from registration until progressive disease (PD), assessed up to 2 years after registration|All participants were evaluable for this endpoint.||months||95% Confidence Interval|Median
740454|NCT00471536|Secondary|Duration of Response|The distribution of response durations will be estimated using the Kaplan-Meier method.|From the time an objective response is first noted to be either a CR or PR to the date progression is documented, assessed up to 1 year|There were no responses.|||||
740455|NCT00471536|Secondary|Confirmed Tumor Response (CR and PR)|Tumor response is defined as the total number of eligible patients whose disease has a complete or partial response to GW786034 according to the RECIST criteria. A confirmed response is defined as a CR or PR and is documented on 2 consecutive evaluations.|Documented on 2 consecutive evaluations 8 weeks apart from the start of the treatment until disease progression/recurrence, assessed up to 1 year|||participants|||Number
740456|NCT00471536|Secondary|Adverse Events Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0|The maximum grade for each adverse event considered to be at least possibly related to treatment will be recorded. Frequency tables will be constructed.|Every 4 weeks during treatment (maximum duration was 44 weeks)|Eighteen of the 19 participants accrued to the study were evaluable for adverse events.||participants|||Number
740457|NCT00471536|Primary|Best Tumor Response (Complete [CR] or Partial Response [PR] by Response Evaluation Criteria in Solid Tumors [RECIST])|"Tumor response is defined as the total number of eligible patients whose disease has a complete or partial response to GW786034 according to the RECIST criteria. Per RECIST v1.0 criteria:
A Complete Response (CR) requires the disappearance of all target lesions.
A Partial Response (PR) requires >=30% decrease in the sum of the longest diameter of target lesions from baseline measurement.
All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response."|Participants will be evaluated every 8 weeks during treatment and up to 1 year after completion of treatment.|All participants meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluated for response.||participants|||Number
740458|NCT00471705|Primary|Failure|At least 50% increase in lesion size at the end of treatment, absence of clinical response at 6 weeks, or any sign of lesion activity 3 months after the end of treatment|Until 3 months posttreatment|||participants|||Number
740459|NCT00471705|Secondary|Recurrence|Reactivation of the lesion at the original site after cure or mucosal compromise during follow-up.|Until 6 months post-treatment|||Participants|||Number
740460|NCT00471705|Primary|Complete Clinical Response|"Complete Clinical response: Initial cure plus the absence of recurrences or mucosal lesions for 6 months after the end of treatment.
Note: nitial cure: Complete re-epithelialization of all ulcers and complete disappearance of the induration up to 3 months after the end of treatment."|Until 6 months posttreatment|The efficacy of the treatments was calculated by intention to treat and by protocol.||participants|||Number
740461|NCT00471718|Primary|Number of Patients Who Demonstrated Treatment Effectiveness Based on Prostate Specific Antigen (PSA) Response in Non-measurable Disease|Patients with a minimum 50% decline in PSA from pre-treatment baseline, confirmed by a second PSA 4 or more weeks later, measured in nanograms per milliliter of blood.|after four weeks|Men with non-measurable disease: all other lesions, bone lesions, leptomeningeal disease, cystic lesions, abdominal masses that are not followed by imaging techniques||participants|||Number
740462|NCT00471718|Secondary|Safety Profile Based on Number of Patients With Worst Grade Toxicities|Not all participants necessarily have an adverse event, thus not everyone will be accounted for in worst-grade toxicities. Likewise, one participant can potentially have more than one event in various grades 1-5 which accounts for the difference in number of patients analyzed and total number in the worst-grade toxicity tables. Tables represent the number of patients with worst-grade toxicity at each of five grades (grade 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening or disabling, grade 5 = death)following NCI Common Toxicity Criteria|at 30 days after final treatment dose|||patients|||Number
740463|NCT00471718|Secondary|Overall Survival|Number of weeks from the date the patient started study drug to the date of the patient's death.|date on study to date of death from any cause|At the time of this analysis, all 27 patients were deceased due to progressive prostate cancer.||Weeks||95% Confidence Interval|Median
740464|NCT00471718|Secondary|Median Time to Tumor Progression|"Number of weeks from the date the patient started study drug to the date of the patient's tumor progression documented radiographically or by PSA testing.
Tumor progression is measured at baseline and after two 28-day cycles"|date on study to date of progression|Patients who received treatment and who were available for measurement of tumor or who available for PSA testing||Weeks||95% Confidence Interval|Median
740465|NCT00471718|Secondary|Number of Patients With Objective Response (CR & PR) by RECIST|Number of participants in each best tumor response category, RECIST criteria (v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in sum longest diameter (LD) of target lesions, progressive disease (PD) > 20% increase in sum LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of smallest sum of the LD of target lesions.|after four weeks|Participants with measurable disease who completed at least one cycle of treatment with tumor assessment.||participants|||Number
740466|NCT00471718|Primary|Maximum Tolerated Dose (MTD)|MTD is determined by the 3+3 study design, in which patients are enrolled in cohorts of 3. In any dose cohort, if 1 patient of 3 experience dose-limiting toxicity (DLT), three additional patients will be enrolled at the same dose level. Whenever >=2 of 6 subjects experience a DLT, then the maximum tolerated dose (MTD) has been exceeded. The MTD is generally one dose below that at which DLT occurs in >= 2 of 6 subjects in any given cohort.|up to four weeks|Phase I patients who received treatment||mg twice a day|||Number
740467|NCT00471822|Secondary|Percentage of Participants With Carriage of Streptococcus Pneumoniae Based on Risk Factors|Participants for carriage of streptococcus pneumoniae were analyzed with respect to various risk factors which included number of bathrooms, number of siblings in the family (multiple siblings), size of the house in meter square (house area), frequency of hand wash in a day, bed sharing, smoking by family member, child breast feeding (breast milk practice), daycare attendance, vaccination for flu and pneumococcus, history of otitis media and upper respiratory infection (URI), antibiotic use and influenza virus infection.|Day 1|Evaluable population included all the participants who met inclusion and exclusion criteria for the study. 'n' signifies those participants who were evaluated for the respective risk factor.||Percentage of Participants|||Number
740468|NCT00471822|Secondary|Percentage of Participants With Carriage of Staphylococcus Aureus in Nostril|Swab cultures obtained from the nostril of participants were tested for the presence of Staphylococcus aureus strains.|Day 1|Evaluable population included all participants who met inclusion and exclusion criteria for the study.||Percentage of Participants|||Number
740469|NCT00471822|Secondary|Antibiotic-Resistant Streptococcus Pneumoniae Strains|Antibiotic resistance is defined as in vitro inhibition of a particular bacterial strain by a concentration of the drug associated with high likelihood of therapeutic failure. Antibiotic resistance for streptococcus pneumoniae was assessed against Penicillin, Cefotaxime, Levofloxacin, Erythromycin and combination of Trimethoprim with sulfamethoxazole. The standard breakpoint value (microbial growth inhibition zone) for Penicillin, Cefotaxime, Levofloxacin, Erythromycin and combination of Trimethoprim with sulfamethoxazole was not more than 8, 4, 13, 15 and 15 millimeter (mm) respectively. Percentage of participants with antibiotic-resistant streptococcus pneumoniae strains are reported. The same participant may have streptococcus pneumoniae strains which is resistance to more than one antibiotic.|Day 1|Evaluable population included all the participants who met inclusion and exclusion criteria for the study. Here, ‘N’ (number of participants analyzed) signifies those participants who were carrier of streptococcus pneumoniae in nasopharynx.||Percentage of Carrier Participants|||Number
740470|NCT00471822|Secondary|Serotype Distribution of Streptococcus Pneumoniae Isolates|Streptococcus pneumoniae in swab culture of nasopharynx were serotyped. The assessment included 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F, non-vaccine, non-typable and missing serotypes. Percentage of participants under different vaccine serotypes in identified isolates of streptococcus pneumonia are reported.|Day 1|Evaluable population included all the participants who met inclusion and exclusion criteria for the study. Here, ‘N’ (number of participants analyzed) signifies those participants who were carrier of streptococcus pneumoniae in nasopharynx.||Percentage of Carrier Participants|||Number
740471|NCT00471822|Primary|Percentage of Participants With Carriage of Streptococcus Pneumoniae in Nasopharynx|Swab cultures obtained from the nasopharynx of participants were tested for the presence of streptococcus pneumoniae strains.|Day 1|Evaluable population included all the participants who met inclusion and exclusion criteria for the study.||Percentage of Participants|||Number
740472|NCT00472030|Secondary|Change in Histamine Release Assay Following Treatment With Omalizumab.|The histamine release assay measures the release of histamine which occurs upon stimulation of basophilic granulocytes depending upon their sensitivity to an allergen.|Up to 24 weeks|We were unable to complete this assay in our research subjects due to technical difficulties.|||||
740473|NCT00472030|Secondary|Decrease in Anti-BP230 Antibody IgG (Anti-bullous Pemphigoid 230 Antibody Immunoglobulin G) At Baseline and Week 16||Up to 24 weeks|The population analyzed included one subject who received Omalizumab treatment on Day 1, Week 2,4,6,8,10,12 and 14 and completed assessments through week 24. A second subject enrolled in the study and received one treatment with Omalizumab and was terminated from the study per investigator at Week 4.||units per milliliter|||Number
740474|NCT00472030|Primary|Median Increase in Prednisone Dosage Measured at Week 4, 8 and 24 in Patients Treated With Omalizumab and in Patients Receiving Standard Therapy.|The total dose of prednisone required to control the bullous pemphigoid at week 4, 8 and 24 weeks was to be calculated in both arms of this study.|Week 4, Week 8 and Week 24|Neither subject required treatment with Prednisone. Since we did not enroll any subject in the Prednisone Standard Therapy Treatment Arm we do not have any measurements for this outcome|||||
740475|NCT00472030|Primary|Percent Decrease in the Total Body Surface Area Affected By Active Bullous Pemphigoid Skin Disease From Day 0 to Week 24.|Measurement of total body surface area affected by bullous pemphigoid active skin disease(active erosions, blisters, and/or lesions) was measured at Day 0 (prior to treatment with Omalizumab) and at 24 weeks (24 weeks is end of study).|Up to 24 weeks|The population analyzed included one subject who received Omalizumab treatment on Day 1, Week 2,4,6,8,10,12 and 14 and completed assessments through week 24. A second subject enrolled in the study and received one treatment with Omalizumab and was terminated from the study per investigator at Week 4.||percentage of active skin disease|||Number
740476|NCT00472030|Secondary|Decrease in Eosinophil Levels Following Treatment With Omalizumab.|The subject's eosinophil count measured at baseline was compared to the eosinophil count at week 8. A normal eosinophil count at the University of Iowa Hospital lab is 0-0.4 cells per microliter|Baseline, 24 weeks.|The population analyzed included one subject who received Omalizumab treatment on Day 1, Week 2,4,6,8,10,12 and 14 and completed assessments through week 24. A second subject enrolled in the study and received one treatment with Omalizumab and was terminated from the study per investigator at Week 4.||cells/microliter|||Number
740477|NCT00472030|Secondary|Decrease in Anti-BP180 IgG (Immunoglobulin G Anti-Bullous Pemphigoid 180 Antibody) Following Treatment With Omalizumab.|Anti-BP180 IgG levels were completed using an Elisa assay. Anti-BP180 IgG levels were obtained prior to baseline and at week 16|Up to 24 weeks|The population analyzed included one subject who received Omalizumab treatment on Day 1, Week 2,4,6,8,10,12 and 14 and completed assessments through week 24. A second subject enrolled in the study and received one treatment with Omalizumab and was terminated from the study per investigator at Week 4.||units per milliliter|||Number
740478|NCT00472030|Primary|Median Time From First Dose of Omalizumab Treatment to Cessation of New Blisters.|The study subject underwent physical examination and was assessed for cessation of new blister formation via physical examination and photography.|Up to 24 weeks|The population analyzed included one subject who received Omalizumab treatment on Day 1, Week 2,4,6,8,10,12 and 14 and completed assessments through week 24. A second subject enrolled in the study and received one treatment with Omalizumab and was terminated from the study per investigator at Week 4.||weeks|||Number
740479|NCT00472056|Primary|Disease-free Survival (DFS)|DFS defined as time from transplantation to disease relapse, disease progression, death during remission, or last follow-up. Evaluation at 3 months and 6 months after transplantation, then every 6 months for 3 years, and then once a year up to 5 years from the transplant date.|Up to 5 years from transplant date.|Analysis was per protocol.||months||Full Range|Mean
740480|NCT00472082|Secondary|Safety, Including Incidence of Post- Transplant Infections, Malignancies, Morbidities, Hypertension, Glucose Intolerance, Serum Cholesterol and Triglycerides Profile Over Time, Development of New Anti-donor Antibodies.||1 year||||||
740481|NCT00472082|Primary|Efficacy Will be Determined by Change in Renal Function as Measured by Cold Iothalamate Glomerular Filtration Rate(GFR)3 Months After Enrollment, and Acute Rejection Episodes Within the First 6 Months Post Enrollment.||6 months from conversion||||||
740482|NCT00472199|Secondary|Baseline, Week 26 Mean Standing Pulse Rate||Baseline, Week 26|Treated Set, all patients who were documented to have taken at least one dose of study medication||bpm||Standard Deviation|Mean
740483|NCT00472199|Secondary|Baseline, Week 26 Mean Supine Pulse Rate||Baseline, Week 26|Treated Set, all patients who were documented to have taken at least one dose of study medication||bpm||Standard Deviation|Mean
740484|NCT00472199|Secondary|Baseline, Week 26 Mean Standing Diastolic Blood Pressure||Baseline, Week 26|Treated Set, all patients who were documented to have taken at least one dose of study medication||mm Hg||Standard Deviation|Mean
740485|NCT00472199|Secondary|Baseline, Week 26 Mean Supine Diastolic Blood Pressure||Baseline, Week 26|Treated Set, all patients who were documented to have taken at least one dose of study medication||mm Hg||Standard Deviation|Mean
740486|NCT00472199|Secondary|Baseline, Week 26 Mean Standing Systolic Blood Pressure||Baseline, Week 26|Treated Set, all patients who were documented to have taken at least one dose of study medication||mm Hg||Standard Deviation|Mean
740487|NCT00472199|Secondary|Baseline, Week 26 Mean Supine Systolic Blood Pressure||Baseline, Week 26|Treated Set, all patients who were documented to have taken at least one dose of study medication||mm Hg||Standard Deviation|Mean
740488|NCT00472199|Secondary|Worsening of RLS Symptoms (by at Least 4 Points in the IRLS Total Score Compared to Baseline) After Treatment Discontinuation|"Worsening of RLS symptoms, in comparison to baseline, following abrupt treatment discontinuation (for patients with no added RLS therapy after study drug discontinuation).
Assessment of worsening of RLS was based on the IRLS total score assessed 7 ± 1 days after treatment discontinuation (the end of the study or premature discontinuation) compared with that at baseline. Analysis considered the number of patients experiencing a clinically relevant deterioration of ≥4 points in total IRLS score 7 ± 1 days after discontinuation of trial medication compared with baseline."|after at least 1 week of treatment discontinuation|Treated Set, all patients who were documented to have taken at least one dose of study medication||participants|||Number
740489|NCT00472199|Secondary|Diagnosis of Classified Augmentation According to Independent Expert Panel|Augmentation is a worsening of RLS symptoms and may manifest as increased severity and the involvement of other extremities or as a shift of RLS symptoms to a time period that is 2 or more hours earlier than was typical of the time of symptom onset during the initial course of beneficial stable treatment or the state before recently starting treatment.|after at least 4 weeks of treatment|Treated Set and where patients received study medication for at least 4 weeks (Treated Set includes all patients who were documented to have taken at least one dose of of treatment)||participants|||Number
740490|NCT00472199|Secondary|Change From Baseline in SF-36 Dimension Physical Component Summary After 26 Weeks|Score ranging from 0 to 100 with higher scores indicating better health|Baseline and 26 weeks|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values||Scores on a scale||Inter-Quartile Range|Median
740491|NCT00472199|Secondary|Change From Baseline in SF-36 Dimension Mental Component Summary After 26 Weeks|Score ranging from 0 to 100 with higher scores indicating better health|Baseline and 26 weeks|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values||Scores on a scale||Inter-Quartile Range|Median
740492|NCT00472199|Secondary|Change From Baseline in SF-36 Dimension Vitality After 26 Weeks|Score ranging from 0 to 100 with higher scores indicating better vitality|Baseline and 26 weeks|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values||Scores on a scale||Inter-Quartile Range|Median
740493|NCT00472199|Secondary|Change From Baseline in SF-36 Dimension Social Functioning After 26 Weeks|Score ranging from 0 to 100 with higher scores indicating better social functioning|Baseline and 26 weeks|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values||Scores on a scale||Inter-Quartile Range|Median
740494|NCT00472199|Secondary|Change From Baseline in SF-36 Dimension Role Limitations Due to Physical Problems After 26 Weeks|Score ranging from 0 to 100 with higher scores indicating less limitations due to physical problems|Baseline and 26 weeks|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values||Scores on a scale||Inter-Quartile Range|Median
740495|NCT00472199|Secondary|Change From Baseline in SF-36 Dimension Role Limitations Due to Emotional Problems After 26 Weeks|Score ranging from 0 to 100 with higher scores indicating less limitations due to emotional problems|Baseline and 26 weeks|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values||Scores on a scale||Inter-Quartile Range|Median
740496|NCT00472199|Secondary|Change From Baseline in SF-36 Dimension Physical Functioning After 26 Weeks|Score ranging from 0 to 100 with higher scores indicating better physical functioning|Baseline and 26 weeks|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values||Scores on a scale||Inter-Quartile Range|Median
740497|NCT00472199|Secondary|Change From Baseline in SF-36 Dimension Mental Health After 26 Weeks|Score ranging from 0 to 100 with higher scores indicating better mental health|Baseline and 26 weeks|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values||Scores on a scale||Inter-Quartile Range|Median
740498|NCT00472199|Secondary|Change From Baseline in SF-36 Dimension General Health After 26 Weeks|Score ranging from 0 to 100 with higher scores indicating better health status|Baseline and 26 weeks|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values||Scores on a scale||Inter-Quartile Range|Median
740499|NCT00472199|Secondary|Change From Baseline in Short Form-36 (SF-36) Dimension Bodily Pain After 26 Weeks|Score ranging from 0 to 100 with higher scores indicating less bodily pain|Baseline and 26 weeks|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values||Scores on a scale||Inter-Quartile Range|Median
740500|NCT00472199|Secondary|Change From Baseline in Quality of Life in RLS (RLS QoL) Score After 26 Weeks|RLS QoL total score ranging from 0 to 100 with higher values indicating better quality of life|Baseline and 26 weeks of treatment|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values||Scores on a scale||Inter-Quartile Range|Median
740501|NCT00472199|Secondary|Change From Baseline in Visual Analogue Scale (VAS) Score for Pain in Limbs After 26 Weeks|The scale measures pain on a continuous 100 mm axis ranging from no pain (0 mm) to unbearable pain (100 mm)|Baseline and 26 weeks of treatment|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values||Scores on a scale||Inter-Quartile Range|Median
740609|NCT00460525|Secondary|Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by ELISA at Day 60.|Titers of Anti-FMP2.1 antibody were determined by ELISA from sera collected at Day 60, prior to the third vaccination.|Day 60 after initial vaccination|Analyses are ITT. No imputation techniques were used.||Titer||95% Confidence Interval|Geometric Mean
740502|NCT00472199|Secondary|Change From Baseline in IRLS Mood Disturbance Score (Item 10) After 26 Weeks|Mood disturbance associated with RLS symptoms ranging from 0 (none) to 4 (very severe)|Baseline and 26 weeks of treatment|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values||scores on a scale||Inter-Quartile Range|Median
740503|NCT00472199|Secondary|"Change From Baseline in RLS-6 Score Tired or Sleepy During the Day After 26 Weeks"|"The score is an 11-point Likert scale, ranging from “none/not at all” (0) to
“very severe” (10), to reflect the patient’s condition during the previous week"|Baseline and 26 weeks of treatment|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values||Scores on a scale||Inter-Quartile Range|Median
740504|NCT00472199|Secondary|"Change From Baseline RLS-6 Score Severity During the Day Engaged in Activities After 26 Weeks"|"The score is an 11-point Likert scale, ranging from “none/not at all” (0) to
“very severe” (10), to reflect the patient’s condition during the previous week"|Baseline and 26 weeks of treatment|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values||Scores on a scale||Inter-Quartile Range|Median
740505|NCT00472199|Secondary|"Change From Baseline in RLS-6 Score Severity During the Day When at Rest After 26 Weeks"|"The score is an 11-point Likert scale, ranging from “none/not at all” (0) to
“very severe” (10), to reflect the patient’s condition during the previous week"|Baseline and 26 weeks of treatment|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values||Scores on a scale||Inter-Quartile Range|Median
740506|NCT00472199|Secondary|"Change From Baseline in RLS-6 Score Severity During the Night After 26 Weeks"|The question was rated on an 11-point Likert scale, ranging from “none/not at all” (0) to “very severe” (10), to reflect the patient’s condition during the previous week|baseline and 26 weeks of treatment|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values||Scores on a scale||Inter-Quartile Range|Median
740507|NCT00472199|Secondary|"Change From Baseline in RLS-6 Score Severity Falling Asleep After 26 Weeks"|"The score is an 11-point Likert scale, ranging from “none/not at all” (0) to
“very severe” (10), to reflect the patient’s condition during the previous week"|Baseline and 26 weeks of treatment|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values||Scores on a scale||Inter-Quartile Range|Median
740508|NCT00472199|Secondary|"Change From Baseline in Restless Legs Syndrome-6 (RLS-6) Score Satisfaction With Sleep After 26 Weeks"|"The score is an 11-point Likert scale, ranging from “none/not at all” (0) to
“very severe” (10), to reflect the patient’s condition during the previous week"|baseline and 26 weeks of treatment|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values||Scores on a scale||Inter-Quartile Range|Median
740509|NCT00472199|Secondary|Patient Global Impression (PGI) Responder Rate|PGI scores ranging from '1' (very much better) to '7' (very much worse), PGI responder have scoring 1 or 2 (at least much better)|after 26 weeks of treatment|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values||participants|||Number
740510|NCT00472199|Secondary|International Restless Legs Syndrome (IRLS) Study Group Rating Scale Responder Rate|IRLS response was defined as at least 50% reduction in IRLS total score from baseline. IRLS total score ranging from 0 (no RLS symptoms) to 40 (very severe symptoms)|after 26 weeks of treatment|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values||participants|||Number
740511|NCT00472199|Secondary|Clinical Global Impression - Global Improvement (CGI-I) Responder Rate|CGI-I scores ranging from '1' (very much improved) to '7' (very much worse), CGI-I responder have scoring 1 or 2 (at least much improved)|after 26 weeks of treatment|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values.||participants|||Number
740512|NCT00472199|Primary|Change From Baseline in International Restless Legs Syndrome Study Group Rating Scale (IRLS) Total Score After 26 Weeks|IRLS total score ranging from 0 (no RLS symptoms) to 40 (very severe RLS symptoms)|Baseline and 26 weeks|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values||Scores on a scale||Standard Error|Least Squares Mean
740513|NCT00472290|Primary|Incidence of Antibody (AB) Formation||During treatment period from first dose of IP to End of Study visit, on Average 56 Weeks.|Safety analysis includes subjects who took at least one dose of romiplostim.||Participant|||Number
740514|NCT00472290|Secondary|Duration of Platelet Response|Platelet response was based on the modified IWG 2006 criteria (Cheson et al, 2006) and was defined as, in the absence of platelet transfusion: an absolute increase in platelet count of ≥ 30 x 10^9/L for a subject starting with a platelet count of ≥ 20 x 10^9/L; or an increase in platelet count from < 20 x 10^9/L to ≥ 20 x 10^9/L and by at least 100% in a subject that started with a platelet count < 20 x 10^9/L.|During treatment period. The average duration of romiplostim exposure is 56 weeks.|Safety analysis includes subjects who received at least one dose of romiplostim.||Weeks|Participants|Full Range|Median
740515|NCT00472290|Secondary|Time to First Platelet Response|Time since first dose of IP to the first platelet response. Platelet response was based on the modified IWG 2006 criteria (Cheson et al, 2006) and was defined as, in the absence of platelet transfusion: an absolute increase in platelet count of ≥ 30 x 10^9/L for a subject starting with a platelet count of ≥ 20 x 10^9/L; or an increase in platelet count from < 20 x 10^9/L to ≥ 20 x 10^9/L and by at least 100% in a subject that started with a platelet count < 20 x 10^9/L.|During treatment period. The average duration of romiplostim exposure is 56 weeks.|Safety analysis includes subjects who received at least one dose of romiplostim.||Weeks|Participants|95% Confidence Interval|Median
740516|NCT00472290|Secondary|Weeks With Platelet Response Per Year|During the time since the first dose of IP to the end of the treatment period. Platelet response was based on the modified IWG 2006 criteria (Cheson et al, 2006) and was defined as, in the absence of platelet transfusion: an absolute increase in platelet count of ≥ 30 x 10^9/L for a subject starting with a platelet count of ≥ 20 x 10^9/L; or an increase in platelet count from < 20 x 10^9/L to ≥ 20 x 10^9/L and by at least 100% in a subject that started with a platelet count < 20 x 10^9/L.|During the treatment period. The average duration of romiplostim exposure is 56 weeks.|Safety analysis includes subjects who received at least one dose of romiplostim.||Weeks/Subject-year|Participants|95% Confidence Interval|Mean
740517|NCT00472290|Secondary|Platelet Transfusion Events Per 100 Subject Years|During the time since the first dose of IP to the end of the treatment period. A discrete platelet transfusion event was defined as any number of platelet transfusions administered within a 3-day period. Platelet transfusions administered more than 3 days apart were counted as separate platelet transfusion events.|During the treatment period. The average duration of romiplostim exposure is 56 weeks.|Safety analysis includes subjects who received at least one dose of romiplostim.||Events/100 subject-year|Participants|95% Confidence Interval|Mean
740518|NCT00472290|Secondary|Weekly Bleeding Events Per 100 Subject Years|During the time since the first dose of IP to the end of the treatment period. A single bleeding event was defined as each individual bleeding episode that originated from a specific organ system (eg, gastrointestinal system or central nervous system). A bleeding event that continued for more than 7 days was counted as separate events every eighth day.|During the treatment period. The average duration of romiplostim exposure is 56 weeks.|Safety analysis includes subjects who received at least one dose of romiplostim.||Events/100 subject-year|Participants|95% Confidence Interval|Mean
740519|NCT00472290|Primary|Overall Summary of Adverse Events||During treatment period from first dose of IP to End of Study visit, on Average 56 Weeks .|Safety analysis includes subjects who took at least one dose of romiplostim.||Participant|||Number
740520|NCT00472303|Secondary|Change in the Patient Assessment of Constipation Symptoms (PAC-SYM) During the Maintenance Phase|"The Constipation Assessment (PAC-SYM) is a 12-item self-report questionnaire that assesses the severity of symptoms of constipation. Participants are asked How severe have each of these symptoms been in the last two weeks? e.g. Pain in your stomach. There are 3 subscales: 4 questions on Abdominal symptoms, 3 questions on rectal symptoms and 5 questions on stool symptoms. Responses are rated on a 5-point Likert Scale ranging from 0 (absence of symptom) to 4 (very severe symptoms). The changes in overall mean and in each of the mean sub-scores vary theoretically from -4 to +4 (where a change of +4 would indicate a change from not present to very severe symptom). If the changes in the overall or subscale mean scores are positive then there is a worsening in symptoms associated with constipation from the start to the end of the maintenance phase. A negative mean change indicates an improvement."|Day 15 (Start of Maintenance); Day 43 (End of Maintenance Phase)|Safety Analysis Set (Maintenance Phase), observed. Start of Maintenance and Endpoint Maintenance observations.||units on a scale||Standard Deviation|Mean
740521|NCT00472303|Secondary|Change in the Patient Assessment of Constipation Symptoms (PAC-SYM) During the Titration Phase|"The Constipation Assessment (PAC-SYM) is a 12-item self-report questionnaire that assesses the severity of symptoms of constipation. Participants are asked How severe have each of these symptoms been in the last two weeks? e.g. Pain in your stomach. There are 3 subscales: 4 questions on Abdominal symptoms, 3 questions on rectal symptoms and 5 questions on stool symptoms. Responses are rated on a 5-point Likert Scale ranging from 0 (absence of symptom) to 4 (very severe symptoms). The changes in overall mean and in each of the mean sub-scores vary theoretically from -4 to +4 (where a change of +4 would indicate a change from not present to very severe symptom). If the changes in the overall or subscale mean scores are positive then there is a worsening in symptoms associated with constipation from the start to the end of the titration phase."|Day 1 (Start of Titration); Day 14 (End of Titration Phase)|Per Protocol Set (Titration Phase), observed. Start of Titration and Endpoint Titration observations.||units on a scale||Standard Deviation|Mean
740522|NCT00472303|Secondary|Clinical Opioid Withdrawal Score (COWS) at the End of the Maintenance Phase.|"This instrument was developed by the National Institute on Drug Abuse. The physical components of withdrawal are primarily evaluated and based on questions and clinical observations. The possible opioid withdrawal effects are assessed using the Clinical Opioid Withdrawal Score (COWS). The COWS is a clinician rated 11-item scale that primarily evaluates the physical components of opioid withdrawal and is based on questions and clinical observations. Responses are rated on a Likert-type scale ranging from 0 to 4 or 5 depending on the item. The total COWS score is the sum of all individual items.
The following withdrawal categories are based on the total COWS score:
None: total score below 5;
Mild: total score from 5 to 12;
Moderate: total score 13 to 24;
Moderately Severe: total score 25 to 36;
Severe: total score above 36. The investigator completes the COWS after participants discontinued trial medication 2 to less than 5 days after last intake of trial medication."|Day 43 (End of Maintenance Phase)|Safety Analysis Set. Participants that did not discontinue due to adverse event during the first week of the maintenance phase and started opioid after last study medication.||participants|||Number
740523|NCT00472303|Secondary|Clinical Opioid Withdrawal Scale (COWS) at the End of the Titration Phase.|"This instrument was developed by the National Institute on Drug Abuse. The physical components of withdrawal are primarily evaluated and based on questions and clinical observations. The possible opioid withdrawal effects are assessed using the Clinical Opioid Withdrawal Score (COWS). The COWS is a clinician rated 11-item scale that primarily evaluates the physical components of opioid withdrawal and is based on questions and clinical observations. Responses are rated on a Likert-type scale ranging from 0 to 4 or 5 depending on the item. The total COWS score is the sum of all individual items.
The following withdrawal categories are based on the total COWS score:
None: total score below 5;
Mild: total score from 5 to 12;
Moderate: total score 13 to 24;
Moderately Severe: total score 25 to 36;
Severe: total score above 36. The investigator completes the COWS after participants discontinued trial medication 2 to less than 5 days after last intake of trial medication."|Day 14 (End of Titration Phase)|Safety Analysis Set (Titration Phase). Participants that took at least one dose of trial medication in the titration phase, and discontinued trial medication at the end or during the titration phase and did not continue on other opioid medication.||participants|||Number
740524|NCT00472303|Secondary|Quality of Sleep (Sleep Questionnaire) During the Maintenance Phase of the Trial.|"Participants were asked the following question: Please rate the overall quality of your sleep last night? The quality of sleep from the start of maintenance to the completion of treatment is reported. The participant could choose one of the following options: Excellent, good, fair and poor."|Day 15 (Start of Maintenance); Day 43 (End of Maintenance Phase)|"FAS (Maintenance Phase) Last Observation Carried Forward for participants re-randomized.
Tapentadol: 105 participants responded at the start and 103 participants at the end.
Morphine: 108 participants responded at the start and 107 participants at the end.
Placebo: 110 participants responded at the start and 107 participants at the end."||participants|||Number
740525|NCT00472303|Secondary|Quality of Sleep (Sleep Questionnaire) in the Titration Phase.|"Participants were asked the following question: Please rate the overall quality of your sleep last night? The quality of sleep from the start of the titration phase to the end of the titration phase was measured. The participant could choose one of the following options: Excellent, good, fair and poor."|Day 1 (Start of Titration); Day 14 (end of Titration Phase)|"Full Analysis Set (Titration Phase), observed. Tapentadol: 302 participants dosed gave a response at the start of titration and from 309 participants at the end of titration.
Morphine: 143 participants dosed gave a response at the start of titration and from 142 participants at the end of titration."||participants|||Number
740526|NCT00472303|Secondary|Patient Global Impression of Change|"In the Patient Global Impression of Change (PGIC) the participant is asked Since I began study treatment, my overall status is. The participant is asked to circle one of seven categories. Scores range from very much improved to very much worse. The question was asked at the end of the maintenance phase with reference to the start of the maintenance phase where the participant continued at the dose that was effective at the end of the Titration Phase."|Day 43 (End of Maintenance Phase)|Full Analysis Set, observed.||participants|||Number
740527|NCT00472303|Secondary|Changes in Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS) Maintenance Phase.|EuroQoL-5D Health State Visual Analog Scale (VAS) is a participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. The values indicated represent the change from Day 15, a negative mean value indicates a worsening of health-related quality of life since the start of the maintenance phase.|Day 15 (Start of Maintenance); Day 43 (End of Maintenance Phase)|Full Analysis Set (Maintenance Phase), observed. Start of Maintenance and Endpoint Maintenance observations.||units on a scale||Standard Deviation|Mean
740528|NCT00472303|Secondary|Change in the EuroQoL (EQ-5D) Health Status Index (United Kingdom Time Trade-off Value Set) Over Time in the Maintenance Phase for Tapentadol and the Placebo Randomized Withdrawal Treatment Arms.|"The participant scores the EuroQol-5D. The EuroQoL-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1 = no problems, 2 = some problems, 3 = extreme problems).
The responses to the five EQ-5D dimensions are scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating full health and 0 representing dead. A negative change in the mean indicates a worsening in health status since the beginning of the maintenance phase. A positive change indicates an improvement in health. The minimal important difference in the Health Status Index is 0.074 (range -0.011 to 0.140)."|Day 15 (Start of Maintenance); Day 43 (End of Maintenance Phase)|Full Analysis Set (Maintenance Phase), observed. Start of Maintenance and Endpoint Maintenance observations. No morphine treatment analysis was planned.||units on a scale||Standard Deviation|Mean
740529|NCT00472303|Secondary|Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS) Titration Phase.|EuroQoL-5D Health State Visual Analog Scale (VAS) is a participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate better health. The values indicated represent the change from Day 1, a positive value indicates an improvement since the start of treatment.|Day 1 (Start of Titration); Day 14 (End of Titration Phase)|Full analysis set (Titration Phase), observed.||units on a scale||Standard Deviation|Mean
740530|NCT00472303|Secondary|Change in the EuroQoL (EQ-5D) Health Status Index (United Kingdom Time Trade-off Value Set) Change From Start of Titration to Endpoint Titration.|"The participant scores the EuroQol-5D. The EuroQoL-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1 = no problems, 2 = some problems, 3 = extreme problems).
The responses to the five EQ-5D dimensions are scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating full health and 0 representing dead. A positive change in the mean indicates that during this phase the health status improved. A positive change indicates an improvement in health. The minimal important difference is 0.074 (range -0.011 to 0.140)."|Day 1 (Start of Titration); Day 14 (End of Titration Phase)|Full analysis set (Titration Phase), observed.||units on a scale||Standard Deviation|Mean
740531|NCT00472303|Secondary|Changes in the Short Form 36® Health Survey (SF-36®) During the Maintenance Phase.|The Short Form 36 (SF-36) includes several brief questions on 8 aspects, (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. Low scores on the Physical Component Summary measure indicate limitations in physical functioning, e.g. a high degree of bodily pain and physical limitations etc. For the Mental Component Summary measure, a low score is indicative of frequent psychological distress, social and role disability due to emotional problems etc. The theoretical range for the physical component score is 12.3279 to 59.6503. The theoretical range for the mental component score is 13.5313 to 59.6503. Positive values for changes in the component scores indicate an improvement.|Day 15 (Start of Maintenance); Day 43 (End of Maintenance Phase)|Full analysis set (Maintenance Phase), observed. Start of Maintenance and Endpoint Maintenance observations.||units on a scale||Standard Deviation|Mean
740572|NCT00460408|Secondary|Incidence of POAEs Per Injection Reported by Age Group (≥ 75 Years)|POAEs: primarily endophthalmitis, as well as increased IOP, vitreous hemorrhage, traumatic cataract, retinal detachment, and retinal tear. Incidence of POAEs per injection = number of specific POAEs divided by the total number of injections received.|Baseline up to 2 years|Safety Population subset of participants ≥ 75 years of age; in addition to endophthalmitis, results for POAE categories presented if number of specific POAEs was ≥1 in at least 1 reporting group.||percent per injection|Participants||Number
740532|NCT00472303|Secondary|Changes in the Short Form 36® Health Survey (SF-36®) During the Titration Phase.|The Short Form 36 (SF-36) includes several brief questions on 8 aspects, (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. Low scores on the Physical Component Summary measure indicate limitations in physical functioning, e.g. a high degree of bodily pain and physical limitations etc. For the Mental Component Summary measure, a low score is indicative of frequent psychological distress, social and role disability due to emotional problems etc. The theoretical range for the physical component score is 12.3279 to 59.6503. The theoretical range for the mental component score is 13.5313 to 59.6503. Positive values for changes in the component scores indicate an improvement.|Day 1 (Start of Titration); Day 14 (End of Titration Phase)|Full analysis set (Titration Period), observed. Start of Titration and Endpoint Titration observations.||units on a scale||Standard Deviation|Mean
740533|NCT00472303|Secondary|The Average Mean Total Daily Dose of Rescue Medication.|Mean total daily dose of rescue medication morphine sulphate immediate release tablets in milligrams per day (mg/day).|Day 1 (Start of Titration Phase) through Day 43 (End of Maintenance Phase)|Full analysis set for each phase of the trial, observed.||milligrams per day of morphine rescue||Standard Deviation|Mean
740534|NCT00472303|Secondary|Number of Participants Using Immediate Release Morphine Rescue Medication in the Maintenance Phase|Participants were issued morphine 10 mg immediate release medication. The number of participants using rescue medication morphine sulfate immediate release 10 mg tablets in the maintenance phase were counted. This use of morphine immediate release was captured in each participant's electronic diary.|Day 15 through Day 43 (End of Maintenance Phase)|Full Analysis Set (Maintenance phase), observed.||participants|||Number
740535|NCT00472303|Secondary|Use of Rescue Medication in the Titration Phase.|"The number of participants using rescue medication morphine sulfate immediate release 10 mg tablets in the titration phase were counted. This data was captured in an electronic diary.
During the trial, morphine immediate release 10 mg was allowed as required without a maximum dose defined. However, participants were only re-randomized if their mean consumption of rescue medication was less or equal to 2 doses (20 mg) per day during the last 3 days of the titration phase)."|Day 1 through Day 14 (End of Titration Phase)|Full Analysis Set (Titration phase), observed.||participants|||Number
740536|NCT00472303|Secondary|Current Pain Intensity Scores, Averaged Per Week by Treatment, During the Maintenance Phase.|"Participants were asked to record their current pain intensity in the morning and evening. Average pain scores are the averages of all scores recorded during the 3 days prior to re-randomization or during each week. The participant scored their pain intensity on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Day 15 through Day 43 (End of Maintenance Phase)|Full Analysis Set (Maintenance Period). Last observation carried forward.||units on a scale||Standard Deviation|Mean
740537|NCT00472303|Secondary|Current Pain Intensity Scores, Averaged Per Week, During the Titration Phase in the Morphine Arm.|"Participants were asked to record their current pain intensity in the morning and evening. Average pain scores are the averages of all scores recorded during the during each week. The participant scored their pain intensity on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Day 1 through Day 14 (End of Titration Phase)|Observed, i.e. participants contributing data via their electronic diary.||units on a scale||Standard Deviation|Mean
740538|NCT00472303|Secondary|Current Pain Intensity Scores, Averaged Per Week, During the Titration Phase in the Tapentadol Arm.|"Participants were asked to record their current pain intensity in the morning and evening. Average pain scores are the averages of all scores recorded during each week. The participant scored their pain intensity on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Day 1 through Day 14 (End of Titration Phase)|Full Analysis Set (Titration Phase), observed.||units on a scale||Standard Deviation|Mean
740539|NCT00472303|Secondary|Average Daily Pain Intensity Scores, Averaged Per Week by Treatment, During the Maintenance Phase.|"Participants were asked to record their average pain over the last 24 hours pain intensity each evening. Average pain scores are the averages of all scores recorded during each week. The participant scored their pain intensity on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Day 18 through Day 43 (End of Maintenance Phase)|Full Analysis Set (Maintenance Period). Last observation carried forward.||units on a scale||Standard Deviation|Mean
740540|NCT00472303|Secondary|Average Daily Pain Intensity Scores, Averaged Per Week by Treatment, During the Titration Phase in the Morphine Treatment Arm.|"Participants were asked to record their average pain over the last 24 hours pain intensity each evening. Average pain scores are the averages of all scores recorded during each week. The participant scored their pain intensity on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Day 1 through Day 14 (End of Titration Phase)|Full Analysis Set (Titration Period), observed.||units on a scale||Standard Deviation|Mean
740541|NCT00472303|Secondary|Average Daily Pain Intensity Scores, Averaged Per Week by Treatment, During the Titration Phase in the Tapentadol Treatment Arm.|"Participants were asked to record their average pain over the last 24 hours pain intensity each evening. Average pain scores are the averages of all scores recorded during each week. The participant scored their pain intensity on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Day 1 through Day 14 (End of Titration Phase)|Full Analysis Set (Titration Period), observed.||units on a scale||Standard Deviation|Mean
740542|NCT00472303|Primary|Number of Participants Scored as Responder in Maintenance Phase.|"A responder is a participant in the study that:
completed 28 days of the maintenance phase
had a numeric rating scale score below 5 on the 11 point scale (where 0 indicates no pain and 10 indicates worst possible pain. This twice daily current pain score was averaged over Day 18 to Day 43.
did not use more than 20 mg of rescue medication per day on average in the 28 day maintenance period (from Day 18 to Day 43).
A participant that met all 3 of the above-mentioned criteria is counted as a responder, in other words the participant benefited from the assigned drug treatment. A participant that failed to meet only 1 of the 3 criteria is not counted as a responder."|Day 18 through Day 43 (End of Maintenance Phase)|Full Analysis Set (Maintenance Phase).||participants|||Number
740543|NCT00472420|Secondary|Event Free Survival (EFS)|EFS was defined as the median time, in months, from the date of study entry disease progression, relapse, secondary malignancy, death or last contact. Relapse was defined by: a) appearance of any new lesion or a ≥ 50% increase in size of previously involved sites, or b) ≥ 50% increase in GTD of any previously identified LN >1 cm in short axis or in the SPD of more than one LN. The 95% CI was estimated using Kaplan-Meier methodology.|Screening, BL, every 21 days thereafter up to Week 27, every 3 months thereafter up to Month 24, Withdrawal Visit (4 weeks after discontinuation of study treatment)|ITT population||months||95% Confidence Interval|Median
740544|NCT00472420|Secondary|Progression Free Survival (PFS)|PFS was defined as the median time, in months, from the date of study entry to disease progression, death due to mantle cell lymphoma, or last contact. Progressive disease (PD) was defined by: a) 50% increase from nadir in the SPD of any previously identified abnormal LN, or b) appearance of any new lesion during or at the end of treatment. The 95% confidence interval (CI) was estimated using Kaplan-Meier methodology.|Screening, BL, every 21 days thereafter up to Week 27, every 3 months thereafter up to Month 24, Withdrawal Visit (4 weeks after discontinuation of study treatment)|ITT population||months||95% Confidence Interval|Median
740545|NCT00472420|Primary|Number of Participants Achieving Complete Remission (CR) (Including Unconfirmed CR [CR(u)]) or Partial Remission (PR)|CR was defined by: a) disappearance of clinical/radiographic evidence of disease, disease-related symptoms, and biochemical abnormalities; b) decrease in lymph nodes (LNs) greater than (>) 1.5 centimeters (cm) in greatest transverse diameter (GTD) to less than (<) 1.5 cm, a decrease in LNs 1.1 - 1.5 cm to 1 cm or 75 percent (%) decrease in sum of the products of GTD (SPD); c) non-palpable spleen, decreased size of enlarged organs, and disappearance of nodules; and d) disappearance of bone marrow (BM) infiltrate. CR(u) was defined as fulfilling a) and c), above, with greater than or equal to (≥) 1 of the following: a) > 75% decrease in SPD of LNs > 1.5 cm, and > 75% decrease in SPD of previously confluent LNs; b) indeterminate BM, or c) confirmed CR. PR was defined by: a) 50% decrease in SPD of the 6 largest LNs; b) no increase in LNs, liver, or spleen size; c) ≥ 50% decrease in splenic and hepatic nodule SPDs; d) no measurable disease in other organs; and e) no new sites of disease.|Screening, Baseline (BL), every 21 days thereafter up to Week 27, every 3 months thereafter up to Month 24, Withdrawal Visit (4 weeks after discontinuation of study treatment)|ITT population||participants|||Number
740546|NCT00472446|Secondary|Hospital Stay|time from surgery to Hospital release in days|90 days|||days||Standard Deviation|Mean
740547|NCT00472446|Secondary|Mean Consumption of Post-operative Analgetics|mean pooled dose of post-operative analgetics|5 days after surgery|||gram||Standard Deviation|Mean
740548|NCT00472446|Secondary|Consumption of Post-operative Analgetics|number of participants taking post-operative analgetics|5 days after surgery|||participants|||Number
740549|NCT00472446|Secondary|Post-operative Pain Measured by Visual Analogue Scale|Patient administered Instrument to indicate pain on a level from 0 to 10. (0: no pain, 10: worst imaginable pain)|24 hours after surgery|||units on a scale||Standard Deviation|Mean
740550|NCT00472446|Primary|Pooled Relative Treatment Effect of VAS|"Pain was obtained using the visual analog scale (VAS) three times daily for the 4 postoperative days (0 = no pain, 10 = worst imaginable pain)
The pooled relative treatment effect is the probability of values being higher in one group than in another group (ranging from 0 to 1)"|4 days after surgery|||pooled relative treatment effect||95% Confidence Interval|Number
740551|NCT00472446|Primary|Post-operative Pain Measured by Visual Analogue Scale|Patient administered Instrument to indicate pain on a level from 0 to 10. (0: no pain, 10: worst imaginable pain)|6 hours after surgery|||units on a scale||Standard Deviation|Mean
740552|NCT00460109|Secondary|Time to Subsequent Therapy|Time to subsequent therapy is defined to be the time from the end of active treatment date to the date subsequent therapy is initiated. The distribution of time to subsequent therapy will be estimated using the method of Kaplan-Meier.|Up to 5 years|||months||Full Range|Median
740553|NCT00460109|Secondary|Duration of Response|Duration of response (DOR) is defined as the time from the date at which the patient’s objective status is first noted to be either a CR, CRu or PR to the earliest date of progression. The distribution of DOR will be estimated using Kaplan-Meier methods. Response criteria for non-Hodgkin's lymphoma (NHL) will be followed. Complete response (CR): (a) Complete disappearance of all detectable disease and disease-related symptoms; (b) All lymph nodes and nodal masses must have regressed to normal size; (c) the spleen must have regressed; CR/unconfirmed (CRu): Those patients who fulfill the criteria in (a) and (c), but with a residual lymph node mass that has regressed by more that 75% in the sum of the products of the greatest diameters (SPD). Partial response (PR): ≥50% decrease in SPD of the six largest dominant nodes or nodal masses; no increase in the size of other nodes, liver, or spleen. Splenic and hepatic nodules must regress by at least 50% in the SPD; No new sites of disease.|Up to 5 years|Overall Number of Participants Analyzed reflects only the number of participants with reported data for this outcome.||months||95% Confidence Interval|Median
740554|NCT00460109|Secondary|Time to Disease Progression|Time to disease progression is defined as the time from registration to the earliest date of documentation of disease progression. If a patient dies without a documentation of disease progression the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death. The distribution of time to disease progression will be estimated using the method of Kaplan-Meier. Progression is defined using the response criteria for non-Hodgkin’s lymphoma, as at least a 50% increase from nadir in the sum of the products of the greatest diameters (SPD) of any previously identified abnormal node for PRs or non-responders, or appearance of any new lesion during or at the end of therapy.|Up to 5 years|||||95% Confidence Interval|Median
740555|NCT00460109|Secondary|Survival Time|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.|Up to 5 years|||||95% Confidence Interval|Median
740573|NCT00460408|Secondary|Incidence of POAEs Per Injection Reported by Age Group (65 to 74 Years)|POAEs: primarily endophthalmitis, as well as increased IOP, vitreous hemorrhage, traumatic cataract, retinal detachment, and retinal tear. Incidence of POAEs per injection = number of specific POAEs divided by the total number of injections received.|Baseline up to 2 years|Safety Population subset of participants 65 to 74 years of age; in addition to endophthalmitis, results for POAE categories presented if number of specific POAEs was ≥1 in at least 1 reporting group.||percent per injection|Participants||Number
740556|NCT00460109|Primary|Proportion of Confirmed Tumor Response (Complete Response [CR], Unconfirmed CR, and Partial Response)|A confirmed tumor response is defined to be either a CR, CRu or PR. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Response criteria for non-Hodgkin’s lymphoma (NHL) will be followed. Complete response (CR): (a) Complete disappearance of all detectable disease and disease-related symptoms; (b) All lymph nodes and nodal masses must have regressed to normal size; (c) the spleen must have regressed; CR/unconfirmed (CRu): Those patients who fulfill the criteria in (a) and (c), but with a residual lymph node mass that has regressed by more that 75% in the sum of the products of the greatest diameters (SPD). Partial response (PR): ≥50% decrease in SPD of the six largest dominant nodes or nodal masses; no increase in the size of other nodes, liver, or spleen. Splenic and hepatic nodules must regress by at least 50% in the SPD; No new sites of disease.|Up to 5 years|||proportion of participants||95% Confidence Interval|Number
740557|NCT00460239|Primary|Physiologic Effects as Assessed by Pupil Diameter||Each experimental test session (8 experimental test sessions assessed for up to 6-7 weeks)|Subjects who completed all test conditions.||millimeters||Standard Deviation|Mean
740558|NCT00460239|Primary|Physiologic Effects as Assessed by Oxygen Saturation||Each experimental test session (8 experimental test sessions assessed for up to 6-7 weeks)|Subjects who completed all test conditions.||percentage of saturated hemoglobin||Standard Deviation|Mean
740559|NCT00460239|Primary|Physiologic Effects as Assessed by Body Temperature||Each experimental test session (8 experimental test sessions assessed for up to 6-7 weeks)|Subjects who completed all test conditions.||Degrees Fahrenheit||Standard Deviation|Mean
740560|NCT00460239|Primary|Physiologic Effects as Assessed by Heart Rate||Each experimental test session (8 experimental test sessions assessed for up to 6-7 weeks)|Subjects who completed all test conditions.||beats/min||Standard Deviation|Mean
740561|NCT00460239|Primary|Physiologic Effects as Assessed by Blood Pressure||Each experimental test session (8 experimental test sessions assessed for up to 6-7 weeks)|Subjects who completed all test conditions.||mmHg||Standard Deviation|Mean
740562|NCT00460239|Primary|Psychomotor/Cognitive Performance Effects Assessed by Trails B|The Trails B task specifically measures set shifting and executive functioning within the Trail-Making Test. Part B consists of 25 circles distributed over a sheet of paper. Participants are asked to connect the circles in an ascending pattern, alternating between numbers and letters (i.e., 1-A-2-B-3-C, etc.). Results are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment.|Each experimental test session (8 experimental test sessions assessed for up to 6-7 weeks)|Subjects who completed all test conditions.||minutes||Standard Deviation|Mean
740563|NCT00460239|Primary|Psychomotor/Cognitive Performance Effects Assessed by Digit Symbol Substitution Test (DSST)|Digit Symbol Substitution Test (DSST) is a sub-test within the Wechsler Adult Intelligence Scale and is frequently used to assess psychomotor performance changes associated with drug effects. The higher the percent correct on this measure the better the performance.|Each experimental test session (8 experimental test sessions assessed for up to 6-7 weeks)|||percentage of correct answers||Standard Deviation|Mean
740564|NCT00460239|Primary|Peak Change From Baseline in Drug Effect Assessed by Visual Analog Scale (VAS)|Opioid agonist effects measured by peak change from baseline drug effect visual analog scale. Scores range from 0 (not all all) to 100 (extremely); higher scores indicate a stronger drug effect.|Each experimental test session (8 experimental test sessions assessed for up to 6-7 weeks)|Subjects who completed all test conditions.||units on a scale||Standard Error|Mean
740565|NCT00460265|Secondary|Progression Free Survival|Time from randomization date to date of disease progression using a modified version of the RECIST v1.0 or death.|Every 6 weeks until disease progression or deaths, upto 56 months|ITT||months||95% Confidence Interval|Median
740566|NCT00460265|Secondary|Time to Response|Time from randomization date to the first confirmed objective response of complete or partial response (that is subsequently confirmed at least 28 days later) using a modified version of the RECIST v1.0.|Every 6 weeks until disease progression, upto 56 months|Included only those subjects with a confirmed complete response or partial response.||months||Inter-Quartile Range|Median
740567|NCT00460265|Secondary|Time to Progression|Time from randomization date to date of disease progression using a modified version of the RECIST 1.0 (see protocol Appendix H)|Every 6 weeks until disease progression, up to 56 months|ITT||months||95% Confidence Interval|Median
740568|NCT00460265|Secondary|Duration of Response|Time from the first confirmed objective response of complete or partial response (that is subsequently confirmed at least 28 days later) to disease progression using a modified version of the RECIST v1.0 (see protocol Appendix H).|Every 6 weeks until disease progression, up to 56 months|Included only those subjects with a confirmed complete or partial response.||months||95% Confidence Interval|Median
740569|NCT00460265|Secondary|Overall Response Rate|An objective tumor response of complete or partial response per modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.0 that was confirmed no less than 28 days after the criteria for response were first met. Complete response = disappearance of all target lesions and partial response = ≥30% reduction in lesion size.|Every 6 weeks until disease progression, up to 56 months|The subset of subjects in the ITT analysis set with at least one baseline uni-dimensionally measurable lesion using a modified version of the RECIST v1.0 (see protocol Appendix H)||subjects|||Number
740570|NCT00460265|Primary|Overall Survival|Time from randomization to death|Upto 56 months|Intention to treat (ITT)||months||95% Confidence Interval|Median
740571|NCT00460408|Secondary|Number of Participants With Serious Hypersensitivity Reactions|Hypersensitivity reactions include Hypersensitivity, Drug hypersensitivity, Anaphylactic shock, Anaphylactic reaction, Anaphylactoid shock, Angioedema Anaphylactoid reaction, Blepharitis allergic, Dermatitis contact, Dermatitis allergic, Toxic skin eruption, Toxic epidermal necrolysis, Drug eruption, Erythema, Erythema multiforme, Tongue oedema, Pharyngeal oedema, Laryngeal oedema, Latex allergy, Paraesthesia oral, Paraesthesia mucosal, Urticaria, Stevens-Johnson syndrome, Rash, Skin reaction, Acute generalised exanthematous pustulosis, Drug rash with eosinphilia and systemic symptoms.|Baseline up to 2 years|Safety Population||participants|||Number
740603|NCT00460525|Secondary|Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by ELISA at Day 730|Titers of Anti-FMP2.1 antibody were determined by ELISA from sera collected at Day 730.|Day 730 after initial vaccination|Analyses are ITT. No imputation techniques were used.||Titer||95% Confidence Interval|Geometric Mean
740574|NCT00460408|Secondary|Incidence of POAEs Per Injection Reported by Age Group (51 to 64 Years)|POAEs: primarily endophthalmitis, as well as increased IOP, vitreous hemorrhage, traumatic cataract, retinal detachment, and retinal tear. Incidence of POAEs per injection = number of specific POAEs divided by the total number of injections received.|Baseline up to 2 years|Safety Population subset of participants 51 to 64 years of age; in addition to endophthalmitis, results for POAE categories presented if number of specific POAEs was ≥1 in at least 1 reporting group.||percent per injection|Participants||Number
740575|NCT00460408|Secondary|Incidence of POAEs Per Injection Reported by Age Group (≤ 50 Years)|POAEs: primarily endophthalmitis, as well as increased IOP, vitreous hemorrhage, traumatic cataract, retinal detachment, and retinal tear. Incidence of POAEs per injection = number of specific POAEs divided by the total number of injections received.|Baseline up to 2 years|Safety Population subset of participants ≤50 years old||percent per injection|Participants||Number
740576|NCT00460408|Primary|Incidence of POAEs Per Injection Reported by Gender (Females)|POAEs: primarily endophthalmitis, as well as increased IOP, vitreous hemorrhage, traumatic cataract, retinal detachment, and retinal tear. Incidence of POAEs per injection = number of specific POAEs divided by the total number of injections received.|Baseline up to 2 years|Safety Population subset of female participants; in addition to endophthalmitis, results for POAE categories presented if number of specific POAEs was ≥1 in at least 1 reporting group.||percent per injection|Participants||Number
740577|NCT00460408|Secondary|Incidence of POAEs Per Injection Reported by Gender (Males)|POAEs: primarily endophthalmitis, as well as increased IOP, vitreous hemorrhage, traumatic cataract, retinal detachment, and retinal tear. Incidence of POAEs per injection = number of specific POAEs divided by the total number of injections received.|Baseline up to 2 years|Safety Population subset of male participants; in addition to endophthalmitis, results for POAE categories presented if number of specific POAEs was ≥1 in at least 1 reporting group.||percent per injection|Participants||Number
740578|NCT00460408|Primary|Incidence of Pertinent Ocular Adverse Events (POAEs) Per Injection|POAEs: primarily endophthalmitis, as well as increased intraocular pressure (IOP), vitreous hemorrhage, traumatic cataract, retinal detachment, and retinal tear. Incidence of POAEs per injection equals (=) number of specific POAEs divided by the total number of injections received.|Baseline up to 2 years|Safety Population: participants who received at least 1 Macugen (pegaptanib sodium) injection; in addition to endophthalmitis, results for POAE categories presented if number of specific POAEs was ≥1 in at least 1 reporting group.||percent per injection|Participants||Number
740579|NCT00460421|Secondary|Long-Term Follow-Up: Overall Survival|Overall survival was defined as the number of days from the date of first investigational product administration to the date of death (regardless of cause)|Up to 4 years duration (Assessments performed on months 6, 9, 12 (+/- 30 Days) for the first year and then annually)|Safety Analysis Set. This set consisted of subjects who received at least one dose of palifermin.||months||Full Range|Median
740580|NCT00460421|Secondary|Long-Term Follow-Up: Progression Free Survival|Progression free survival (PFS) was defined as the number of days between the date of first investigational product administration and the date when physical or radiological evidence of disease progression is determined or death (regardless of cause)|Up to 4 years duration (Assessments performed on months 6, 9, 12 (+/- 30 Days) for the first year and then annually)|Safety Analysis Set. This set consisted of subjects who received at least one dose of palifermin.||months||Full Range|Median
740581|NCT00460421|Secondary|Long-Term Follow-Up: Incidence of Secondary Malignancies||Up to 4 years duration (Assessments performed on months 6, 9, 12 (+/- 30 Days) for the first year and then annually)|Safety Analysis Set. This set consisted of subjects who received at least one dose of palifermin.||percentage of participants|||Number
740582|NCT00460421|Secondary|Pharmacokinetics of Palifermin, AUCtau After the 3rd IV Bolus Injection for Multiple Dose Levels|"The AUC was estimated using the linear/log trapezoidal method for AUC0-tau from time zero to the end of the dosing interval (24 hours (hrs) post-dose)
Data collected at time points: 0, 2 minutes (min), 15 min, 30 min, 60 min, 2 hrs, 4 hrs, 6, hrs, 10, hrs and 24 hrs post-dose."|Day -8|Pharmacokinetic Analysis Set. This set consists of all subjects who receive at least one dose of palifermin and who have a sufficient number of serum concentration data points to allow calculation of the pharmacokinetic variables.||ng*hr/mL||Full Range|Median
740583|NCT00460421|Secondary|Pharmacokinetics of Palifermin, Area Under the Concentration Time Curve From Zero to the End of the Dosing Interval (AUCtau) After the 1st IV Bolus Injection for Multiple Dose Levels|"The AUC was estimated using the linear/log trapezoidal method for AUC0-tau from time zero to the end of the dosing interval (24 hours (hrs) post-dose)
Data collected at time points: 0, 2 minutes (min), 15 min, 30 min, 60 min, 2 hrs, 4 hrs, 6, hrs, 10, hrs and 24 hrs post-dose."|Day -10|Pharmacokinetic Analysis Set. This set consists of all subjects who receive at least one dose of palifermin and who have a sufficient number of serum concentration data points to allow calculation of the pharmacokinetic variables.||ng*hr/mL||Full Range|Median
740584|NCT00460421|Secondary|Pharmacokinetics of Palifermin, t½,z After the 3rd IV Bolus Injection for Multiple Dose Levels|The terminal half-life was calculated as ln(2)/lambda,z where lambda,z was estimated using at least three quantifiable serum concentrations of the terminal log-linear phase.|Day -8|Pharmacokinetic Analysis Set. This set consists of all subjects who receive at least one dose of palifermin and who have a sufficient number of serum concentration data points to allow calculation of the pharmacokinetic variables.||hour||Full Range|Median
740585|NCT00460421|Secondary|Pharmacokinetics of Palifermin, Terminal Half-life (t½,z) After the 1st IV Bolus Injection for Multiple Dose Levels|The terminal half-life was calculated as ln(2)/lambda,z where lambda,z was estimated using at least three quantifiable serum concentrations of the terminal log-linear phase.|Day -10|Pharmacokinetic Analysis Set. This set consists of all subjects who receive at least one dose of palifermin and who have a sufficient number of serum concentration data points to allow calculation of the pharmacokinetic variables.||hour||Full Range|Median
740586|NCT00460421|Secondary|Pharmacokinetics of Palifermin, Volume of Distribution at Steady State (Vss) After the 1st IV Bolus Injection for Multiple Dose Levels||Day -10|Pharmacokinetic Analysis Set. This set consists of all subjects who receive at least one dose of palifermin and who have a sufficient number of serum concentration data points to allow calculation of the pharmacokinetic variables.||mL/kg||Full Range|Median
740604|NCT00460525|Secondary|Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by ELISA at Day 547|Titers of Anti-FMP2.1 antibody were determined by ELISA from sera collected at Day 547.|Day 547 after initial vaccination|Analyses are ITT. No imputation techniques were used.||Titer||95% Confidence Interval|Geometric Mean
740587|NCT00460421|Secondary|Pharmacokinetics of Palifermin, Clearence (CL) After the 1st Intravenous (IV) Bolus Injection for Multiple Dose Levels|Clearence was estimated as dose divided by the area under serum concentration-time curve from time zero to infinity where the dose was given in amount palifermin actually administered.|Day -10|Pharmacokinetic Analysis Set. This set consists of all subjects who receive at least one dose of palifermin and who have a sufficient number of serum concentration data points to allow calculation of the pharmacokinetic variables.||mL/hr/kg||Full Range|Median
740588|NCT00460421|Secondary|Incidence of Laboratory Abnormalities|The percentage of participants with a laboratory value outside the normal ranges during the study.|Approximately 1 1/2 months duration (Through Day +30/End of Treatment)|Safety Analysis Set. This set consisted of subjects who received at least one dose of palifermin.||percentage of participants|||Number
740589|NCT00460421|Secondary|Incidence of Severe Adverse Events (AEs)|The percentage of participants with a severe AE during the study was assessed.|Approximately 1 1/2 months duration (Through Day +30/End of Treatment)|Safety Analysis Set. This set consisted of subjects who received at least one dose of palifermin.||percentage of participants|||Number
740590|NCT00460421|Secondary|Incidence of Serum Palifermin Antibody Formation|The percentage of participants developing palifermin antibodies during the study was assessed.|Approximately 4 month duration (Through Day + 100 (+/- 40 days))|Safety Analysis Set. This set consisted of subjects who received at least one dose of palifermin.||percentage of participants|||Number
740591|NCT00460421|Primary|Incidence of Dose Limiting Toxicities (DLTs)|"A DLT is appearance of side effects during treatment severe enough to prevent further increase in dosage or strength of treatment agent, or to prevent continuation of treatment at any dosage level.
A DLT was defined as: Grade 3 or 4 AE [based on Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE) v3.0] considered by the investigator to be related to palifermin with the exceptions: Grade 3 erythema, pruritus or rash that resolves within 7 days of the last dose of palifermin.
The percentage of particiapnts with a DLT during the study was assessed."|Approximately 1 month duration (Day -10 through Day +16)|Safety Analysis Set. This set consisted of subjects who received at least one dose of palifermin.||percentage of participants|||Number
740592|NCT00460434|Secondary|Incontinence Severity Index|Scores on the Incontinence Severity Index range from 1 to 12, with higher scores indicating greater severity. Results measure average change in scores from baseline.|Baseline, 3 months, and 12 months post-surgery|Women who completed the Incontinence Severity Index survey at baseline and 3 and 12 months after the index surgery.||units on a scale||Standard Deviation|Mean
740593|NCT00460434|Secondary|Urinary Distress Inventory (UDI) Stress Subscale|Scores on the UDI subscales range from 0 to 100, with higher score indicating more symptoms. Results measure the average change in scores from baseline to follow-up.|Baseline, 3 months, and 12 months post-surgery|Women who completed the UDI stress subscale survey at baseline and 3 and 12 months after the index surgery.||units on a scale||Standard Deviation|Mean
740594|NCT00460434|Secondary|Urinary Distress Inventory (UDI) Irritative Symptom Subscale|Scores on the UDI subscales range from 0 to 100, with higher score indicating more symptoms. Results measure the average change in scores from baseline to follow-up.|Baseline, 3 months, and 12 months post-surgery|Women who completed the UDI irritative symptom subscale survey at baseline and 3 months after the index surgery.||units on a scale||Standard Deviation|Mean
740595|NCT00460434|Secondary|Urinary Distress Inventory (UDI) Obstructive Symptom Subscale|Scores on the UDI subscales range from 0 to 100, with higher score indicating more symptoms. Results measure the average change in scores from baseline to follow-up.|Baseline, 3 months, and 12 months post-surgery|Women who completed the UDI obstructive symptom subscale survey at baseline and 3 and 12 months after the index surgery.||units on a scale||Standard Deviation|Mean
740596|NCT00460434|Secondary|Pelvic Floor Distress Inventory (PFDI) Urinary Distress Inventory (UDI)|PFDI is a symptom inventory for pelvic floor disorders. Scores ranges from 0 to 300, with higher scores indicating more symptoms. Results measure the average change in scores from baseline to follow-up.|Baseline, 3 months, and 12 months post-surgery|Women who completed the PFDI UDI survey at baseline and 3 and 12 months after the index surgery.||units on a scale||Standard Deviation|Mean
740597|NCT00460434|Secondary|Treatment for Incontinence|The need for treatment for any urinary incontinence, including surgery, medication, pessary for incontinence, supervised pelvic-muscle exercises, timed voiding and fluid management, periurethral injection, botulinum toxin injection, neuromodulation, or other treatment for incontinence.|3 months post-surgery|Women who reported whether or not they needed treatment for any urinary incontinence.||Participants|||Count of Participants
740598|NCT00460434|Secondary|Symptoms of Incontinence|Symptoms that were at least moderately bothersome to the participant (as measured by a response of “moderately” or “quite a bit” to any of the four items on the Pelvic Floor Distress Inventory regarding leakage).|3 and 12 Months Post-surgery|Women who completed questions in the Pelvic Floor Distress Inventory regarding leakage 3 and 12 months after their index surgery.||Participants|||Count of Participants
740599|NCT00460434|Secondary|Positive Cough Stress Test|A leakage of urine with coughing or straining in either the supine or standing position with the bladder filled through a urethral catheter to 300 ml.|3 and 12 Months Post-surgery|Women who came in for 3 and 12 month post-op office visits and completed a cough stress test.||Participants|||Count of Participants
740600|NCT00460434|Secondary|Medical Outcomes Study 36-Item Short Form Health Survey|This survey is a generic health-related quality of life measure. Scores have normalized values with a mean of 50 and a standard deviation of 10, with higher scores indicating better health status. Results measure the average change in scores from baseline to follow-up.|Baseline, 3 months, and 12 Months post-surgery|Women who completed the Medical Outcomes Study 36-Item Short Form Health Survey at baseline and 3 and 12 months after the index surgery.||units on a scale||Standard Deviation|Mean
740601|NCT00460434|Primary|Prevalence of Bothersome Urinary Incontinence at 12 Months Following Index Surgery|Defined as a positive cough stress test or report of bothersome incontinence symptoms.|12 months post-surgery|||Participants|||Count of Participants
740602|NCT00460434|Primary|Number of Participants With Treatment Failure Defined as Subsequent Treatment for Urinary Incontinence, Signs or Symptoms of Bothersome Urinary Incontinence|Defined as a positive cough stress test, bothersome incontinence symptoms, or treatment for urinary incontinence, and urinary incontinence (stress, urge, or mixed), regardless of whether interim treatment for incontinence had been provided.|3 months post-surgery|||Participants|||Count of Participants
740610|NCT00460525|Primary|Number of Subjects Reporting Serious Adverse Events|A serious adverse event was defined as any untoward medical occurrence that results in death, is life threatening, results in persistent or significant disability/incapacity, requires in-patient hospitalization or prolongation of existing hospitalization or is a congenital anomaly/birth defect in the offspring of a study subject. In addition, important medical events that may jeopardize the participant or may require intervention to prevent one of the other outcomes listed above was considered serious.|24 months after initial vaccination|||Participants|||Number
740611|NCT00460525|Primary|Time to First Clinical Malaria Episode With Significant Parasitemia (2500/mm^3) and Temperature of Greater Than or Equal to 37.5 Degrees C.|Time to first clinical malaria episode is displayed in a life table format to display the number of subjects at risk, the number with first clinical episode and the number censored at each time point.|Occurring between randomization and 6 months after the assigned date of the 3rd immunization.|||Participants|||Number
740612|NCT00460525|Primary|Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Third Vaccination|Unsolicited non-serious adverse events reported are those occurring within 30 days after vaccination. The categories are the MedDRA System Organ Classes for which at least one adverse event was reported. All non-serious adverse events are included, regardless of severity or relationship to vaccination.|Day 0-29 after third vaccination|All subjects receiving the vaccination are included.||Adverse Events|||Number
740613|NCT00460525|Primary|Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Second Vaccination|Unsolicited non-serious adverse events reported are those occurring within 30 days after vaccination. The categories are the MedDRA System Organ Classes for which at least one adverse event was reported. All non-serious adverse events are included, regardless of severity or relationship to vaccination.|Day 0-29 after second vaccination|All subjects receiving the vaccination are included.||Adverse Events|||Number
740614|NCT00460525|Secondary|Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by ELISA at Day 30.|Titers of Anti-FMP2.1 antibody were determined by ELISA from sera collected at Day 30, prior to the second vaccination.|Day 30 after initial vaccination|Analyses are ITT. No imputation techniques were used.||Titer||95% Confidence Interval|Geometric Mean
740615|NCT00460525|Secondary|Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by Enzyme Linked ImmunoSorbent Assay (ELISA) at Day 0|Titers of Anti-FMP2.1 antibody were determined by ELISA from sera collected at Day 0 prior to the first vaccination.|Day 0|Analyses are ITT. No imputation techniques were used.||Titer||95% Confidence Interval|Geometric Mean
740616|NCT00460525|Secondary|Time to First Clinical Malaria Episode With Parasites With AMA-1 Genotype Homologous to the 3D7 Strain of P. Falciparum With Respect to Entire AMA-1 Sequence and With Respect to Key Amino Acid Residues.||Occurring between randomization and 6 months after the assigned date of the 3rd immunization.||||||
740617|NCT00460525|Secondary|Incidence Density of Clinical Malaria Episode|Clinical malaria episode was defined by significant parasitemia (2500/mm^3) and temperature of greater than or equal to 37.5 degrees C. Event rate was determined by dividing the number of episodes (150 for the Rabies group and 121 for the FMP2.1/ASO2A group) by the number of Person Years at Risk (PYAR) (126.341 for Rabies group and 127.411 for the FMP2.1/ASO2A group).|Between randomization and 6 months after 3rd immunization.|Analyses are ITT.||Events Per PYAR|||Number
740618|NCT00460525|Primary|Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the First Vaccination|Unsolicited non-serious adverse events reported are those occurring within 30 days after vaccination. The categories are the MedDRA System Organ Classes for which at least one adverse event was reported. All non-serious adverse events are included, regardless of severity or relationship to vaccination.|Day 0-29 after first vaccination|All subjects receiving the vaccination are included.||Adverse Events|||Number
740619|NCT00460525|Primary|Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Third Vaccination.|"Solicited symptoms were recorded by study staff at clinic visits on Days 0, 1, 2 and 7 after vaccination. Reported Limitation of Arm Motion refers to the parents' report of the symptom while Limitation of Arm Motion refers to the clinicians' assessment of the symptom, collected separately."|0-7 days after the third vaccination|All subjects receiving the vaccination are included.||Participants|||Number
740620|NCT00460525|Primary|Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Second Vaccination.|"Solicited symptoms were recorded by study staff at clinic visits on Days 0, 1, 2 and 7 after vaccination. Reported Limitation of Arm Motion refers to the parents' report of the symptom while Limitation of Arm Motion refers to the clinicians' assessment of the symptom, collected separately."|0-7 days after the second vaccination|All subjects receiving the vaccination are included.||Participants|||Number
740621|NCT00460525|Primary|Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the First Vaccination|"Solicited symptoms were recorded by study staff at clinic visits on Days 0, 1, 2 and 7 after each vaccination. Reported Limitation of Arm Motion refers to the parents' report of the symptom while Limitation of Arm Motion refers to the clinicians' assessment of the symptom, collected separately."|0-7 days after first vaccination|All subjects receiving the vaccination are included.||Participants|||Number
740622|NCT00460551|Primary|Progression Free Survival Verified by Imaging Techniques.|Disease progression was planned to be confirmed using RECIST criteria J Natl Cancer Inst 2000;92:205-16|Until disease progression|Data was not collected. Imaging scans were not taken during part 1A. The trial was prematurely closed when 13 patients were enrolled in part 1A. Scans were planned for part 1B and 2. No patients continued to part 1B and part 2.||Participants|||Number
740623|NCT00460551|Secondary|Adverse Events|Number of participants reporting at least one adverse event|Up to 3 months|Number of patients reporting at least one adverse event||participants|||Number
740624|NCT00460564|Secondary|Mean Change From Baseline (at the Start of the DB Phase) in the Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Physiotherapist/Occupational Therapist at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase|The CGI score of functional disability was assessed at each visit using the 11-point Numeric Rating Scale (NRS) (-5=Worst Possible to 5=Best Possible) at each time point from baseline (at the start of the double-blind phase) to Week 48.|Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score||Points on a scale||Standard Deviation|Mean
740625|NCT00460564|Secondary|Mean Change From Baseline (at the Start of the Double-blind Phase) in the Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Participant at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase|The CGI score of functional disability was assessed at each visit using the 11-point Numeric Rating Scale (NRS) (-5=Worst Possible to 5=Best Possible) at each time point from baseline (at the start of the double-blind phase) to Week 48.|Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score||Points on a scale||Standard Deviation|Mean
740626|NCT00460564|Secondary|Mean Change From Baseline (at the Start of the Double-blind Phase) in the Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Investigator at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase|The CGI score of functional disability was assessed at each visit using the 11-point Numeric Rating Scale (NRS) (-5=Worst Possible to 5=Best Possible) at each time point from baseline (at the start of the double-blind phase) to Week 48.|Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score||Points on a scale||Standard Deviation|Mean
740627|NCT00460564|Secondary|Mean Change From Baseline (at the Start of the Double-blind Phase) in the Disability Assessment Scale (DAS) Score of Limb Posture at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase|The DAS score of Limb Posture was assessed using a 4-point scale (0=No functional disability to 3=Severe disability) at each time point from baseline (at the start of the double-blind phase) to Week 48. BTX was injected in participants up to 3 times from Weeks 12 to 36 when participants met re-injection criteria. Measurements were taken at each point until Week 48 and summarized by the number of weeks after the re-injection in individuals (4, 8, and 12 weeks after each injection) in open-label phase; thus, measurements could have been taken up to Week 48 (12 weeks after the Week 36 injection).|Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score||Points on a scale||Standard Deviation|Mean
740628|NCT00460564|Secondary|Mean Change From Baseline (at the Start of the Double-blind Phase) in the Disability Assessment Scale (DAS) Score of Dressing at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase|The DAS score of Dressing was assessed using a 4-point scale (0=No functional disability to 3=Severe disability) at each time point from baseline (at the start of the double-blind phase) to Week 48. BTX was injected in participants up to 3 times from Week 12 to Week 36 when participants met re-injection criteria. Measurements were taken at each point until Week 48 and summarized by the number of weeks after the re-injection in individuals (4, 8, and 12 weeks after each injection) in open-label phase; thus, measurements could have been taken up to Week 48 (12 weeks after the Week 36 injection).|Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score||Points on a scale||Standard Deviation|Mean
740629|NCT00460564|Secondary|Mean Change From Baseline (at the Start of the Double-blind Phase) in the Disability Assessment Scale (DAS) Score of Pain at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase|The DAS score of Pain was assessed using a 4-point scale (0=No functional disability to 3=Severe disability) at each time point from baseline (at the start of the double-blind phase) to Week 48. BTX was injected in participants up to 3 times from Week 12 to Week 36 when participants met re-injection criteria. Measurements were taken at each point until Week 48 and summarized by the number of weeks after the re-injection in individuals (4, 8, and 12 weeks after each injection) in open-label phase; thus, measurements could have been taken up to Week 48 (12 weeks after the Week 36 injection).|Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score||Points on a scale||Standard Deviation|Mean
740630|NCT00460564|Secondary|Mean Change From Baseline (at the Start of the Double-blind Phase) in the Disability Assessment Scale (DAS) Score of Hygiene at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase|The DAS score of Hygiene was assessed using a 4-point scale (0=No functional disability; 3=Severe disability) at each time point from baseline (at the start of the double-blind phase) to Week 48. BTX was injected in participants up to 3 times from Week 12 to Week 36 when participants met re-injection criteria. Measurements were taken at each point until Week 48 and summarized by the number of weeks after the re-injection in individuals (4, 8, and 12 weeks after each injection) in open-label phase; thus, measurements could have been taken up to Week 48 (12 weeks after the Week 36 injection).|Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score||Points on a scale||Standard Deviation|Mean
740631|NCT00460564|Secondary|Mean Change From Baseline (at the Start of the Double-blind Phase) in the Disability Assessment Scale (DAS) Score of Principal Measure at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase|DAS scores of Hygiene, Pain, Dressing, and Limb posture were assessed using a 4-point scale (0=No functional disability to 3=Severe disability). Prior to the first injection, the investigator, in consultation with the participant, selected one functional disability item and assessed it as a principal measure at each time point from baseline (at the start of the double-blind phase) to Week 48.|Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score||Points on a scale||Standard Deviation|Mean
740779|NCT00472797|Secondary|Total Score for Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ)|The MSTCQ Global Side Effect domain assesses the subjects degree of satisfaction on global side effect questions 9, 10 & 11 on a scale from 3 (not at all satisfied) to 15 (extremely satisfied).|Baseline and Week 12|Intent to Treat (ITT) and Last Observation Carried Forward (LOCF) Higher scores indicate a more favorable response||score on scale||Standard Deviation|Mean
740632|NCT00460564|Secondary|Mean Change From Baseline (at the Start of the Double-blind Phase) in the MAS Finger Score From at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase|The investigator assessed the MAS finger score using a 6-point scale (0, 1, 1+, 2, 3, and 4; 0=No increase in muscle tone to 4=Affected part[s] rigid in flexion or extension) at each time point from baseline (at the start of the double-blind phase) to week 48. The “+1” (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder [less than half] of ROM [range of motion]) of MAS score is regarded as score 1.5.|Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score||Points on a scale||Standard Deviation|Mean
740633|NCT00460564|Secondary|Mean Change From Baseline (at the Start of the Double-blind Phase) in the MAS Wrist Score at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase|The investigator assessed the MAS wrist score using a 6-point scale (0, 1, 1+, 2, 3, and 4; 0=no increase in muscle tone to 4=affected part[s] rigid in flexion or extension) at each time point from baseline (at the start of the double-blind phase) to week 48. The “+1” (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder ([less than half] of ROM [range of motion]) of MAS score is regarded as score 1.5.|Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score||Points on a scale||Standard Deviation|Mean
740634|NCT00460564|Secondary|Mean Change From Baseline in Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Physiotherapist/Occupational Therapist From Baseline to Week 12 of the Double-blind Phase|The CGI score of functional disability was assessed at each visit using the 11-point Numeric Rating Scale (NRS) (-5=Worst Possible to 5=Best Possible) at each time point in the double-blind phase.|Baseline; Weeks 1, 4, 6, 8, and 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score||Points on a scale||Standard Deviation|Mean
740635|NCT00460564|Secondary|Mean Change From Baseline in Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Participant From Baseline to Week 12 of the Double-blind Phase|The CGI score of functional disability was assessed at each visit using the 11-point Numeric Rating Scale (NRS) (-5=Worst Possible to 5=Best Possible) at each time point in the double-blind phase.|Baseline; Weeks 1, 4, 6, 8, and 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score||Points on a scale||Standard Deviation|Mean
740636|NCT00460564|Secondary|Mean Change From Baseline in Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Investigator From Baseline to Week 12 of the Double-blind Phase|The CGI score of functional disability was assessed at each visit using the 11-point Numeric Rating Scale (NRS) (-5=Worst Possible to 5=Best Possible) at each time point in the double-blind phase.|Baseline; Weeks 1, 4, 6, 8, and 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score||Points on a scale||Standard Deviation|Mean
740637|NCT00460564|Secondary|Mean Change From Baseline in Disability Assessment Scale (DAS) Score of Limb Posture From Baseline to Week 12 of the Double-blind Phase|DAS score of Limb Posture was assessed using a 4-point scale (0=No functional disability to 3=Severe disability) at each time point in the double-blind phase.|Baseline; Weeks 1, 4, 6, 8, and 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score||Points on a scale||Standard Deviation|Mean
740638|NCT00460564|Secondary|Mean Change From Baseline in Disability Assessment Scale (DAS) Score of Dressing From Baseline to Week 12 of the Double-blind Phase|DAS score of Dressing was assessed using a 4-point scale (0=No functional disability to 3=Severe disability) at each time point in the double-blind phase.|Baseline; Weeks 1, 4, 6, 8, and 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score||Points on a scale||Standard Deviation|Mean
740639|NCT00460564|Secondary|Mean Change From Baseline in Disability Assessment Scale (DAS) Score of Pain From Baseline to Week 12 of the Double-blind Phase|DAS score of pain was assessed using a 4-point scale (0=No functional disability to 3=Severe disability) at each time point in the double-blind phase.|Baseline; Weeks 1, 4, 6, 8, and 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score||Points on a scale||Standard Deviation|Mean
740640|NCT00460564|Secondary|Mean Change From Baseline in Disability Assessment Scale (DAS) Score of Hygiene From Baseline to week12 of the Double-blind Phase|DAS score of Hygiene was assessed using a 4-point scale (0=No functional disability to 3=Severe disability) at each time point in double-blind phase.|Baseline; Weeks 1, 4, 6, 8, and 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score||Points on a scale||Standard Deviation|Mean
740641|NCT00460564|Secondary|Mean Change From Baseline in Disability Assessment Scale (DAS) Score of Principal Measure From Baseline to Week 12 of the Double-blind Phase|DAS scores of Hygiene, Pain, Dressing, and Limb posture were assessed using a 4-point scale (0=No functional disability to 3=Severe disability). Prior to the first injection, the investigator, in consultation with the participant, selected one functional disability item and assessed it as a principal measure at each time point in the double-blind phase.|Baseline; Weeks 1, 4, 6, 8, and 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score||Points on a scale||Standard Deviation|Mean
740642|NCT00460564|Secondary|Mean Change From Baseline in MAS Finger Score From Baseline to Week 12 of the Double-blind Phase|The investigator assessed MAS finger score using a 6-point scale (0, 1, 1+, 2, 3, and 4; 0=No increase in muscle tone to 4=Affected part[s] rigid in flexion or extension) at each time point in the double-blind phase. The “+1” (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder [less than half] of ROM [range of motion]) of MAS score is regarded as score 1.5.|Baseline; Weeks 1, 4, 6, 8, and 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score||Points on a scale||Standard Deviation|Mean
740643|NCT00460564|Secondary|Mean Change From Baseline in MAS Wrist Score From Baseline to Week 12 of the Double-blind Phase|The investigator assessed MAS wrist score using a 6-point scale (0, 1, 1+, 2, 3, and 4; 0=No increase in muscle tone to 4=Affected part[s] rigid in flexion or extension) at each time point in the double-blind phase. The “+1” (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder [less than half] of ROM [range of motion]) of MAS score is regarded as score 1.5.|Baseline; Weeks 1, 4, 6, 8, and 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score||Points on a scale||Standard Deviation|Mean
740644|NCT00460564|Secondary|Area Under the Curve (AUC) for the Change From Baseline in Modified Ashworth Scale (MAS) Wrist Score to the End of the DB Phase (Week 12) in the Low-dose Groups|Change from baseline in MAS wrist score using a 6-point scale (0, 1, 1+ [regarded as 1.5], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part[s] rigid in flexion/extension) to each time point in the DB phase was calculated. In the graph plotting time points on the horizontal axis (HA) and changes from baseline on the vertical axis, the area surrounded by the MAS wrist score change curve and the HA was calculated and used as a summary index (AUC) for assessment of the MAS wrist score. Negative changes from baseline indicate improvement, and the area under the AUC has a negative sign.|Baseline, Week 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score||Score*week||Standard Deviation|Mean
740645|NCT00460564|Primary|Area Under the Curve (AUC) for the Change From Baseline in Modified Ashworth Scale (MAS) Wrist Score to the End of the DB Phase (Week 12) in the High-dose Groups|Change from baseline in MAS wrist score using a 6-point scale (0, 1, 1+ [regarded as 1.5], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part[s] rigid in flexion/extension) to each time point in the DB phase was calculated. In the graph plotting time points on the horizontal axis and changes from baseline on the vertical axis, the area surrounded by the MAS wrist score change curve and the horizontal axis was calculated and used as a summary index (AUC) for assessment of the MAS wrist score. Negative changes from baseline indicate improvement, and the AUC has a negative sign.|Baseline, Week 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score||Score*week||Standard Deviation|Mean
740646|NCT00460577|Primary|Mean Change in the Conway Clinical Scale Score From Baseline to Final Evaluation|Mean Change from Baseline to Final Evaluation in the Per Protocol population assessed by the Conway Clinical Scale. Assessment of the following: Wheezing, Accessory Muscle Use and Pulse Frequency in a 0 to 3 point scale according to severity for a minimum of 0 points and a total of 9 points in a very severe clinical case.|Baseline,4 hours|Per protocol population: defined as number of patients who did not present any major deviations from protocol and received at least one dose of investigational study drug.||score on a scale||Standard Deviation|Mean
740647|NCT00460577|Primary|Mean Change in Pulse Oxymetry From Baseline to Final Evaluation|Mean Change from Baseline to Final Evaluation in the Per Protocol population assessed by Pulse Oximetry used to monitor the percentage of oxygen saturation of hemoglobin in the blood.|Baseline, 4 hours|Per protocol population: defined as number of patients who did not present any major deviations from protocol and received at least one dose of investigational study drug.||percentage||Standard Deviation|Mean
740648|NCT00460577|Primary|Mean Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to Final Evaluation|Mean Change from Baseline to Final Evaluation in the Per Protocol population assessed by Forced Expiratory Volume in 1 second. FEV1 is defined as the volume of air that can be forced out of the lungs in 1 second after taking a deep breath.|Baseline,4 hours|Per protocol population: defined as number of patients who did not present any major deviations from protocol and received at least one dose of investigational study drug.||Liters||Standard Deviation|Mean
740649|NCT00460577|Secondary|Pharmacoeconomic Analysis|Pharmacoeconomic analysis comparing the mean direct costs (total cost per prescription) of treatment with Formoterol (Foradil®) to treatment with Fenoterol 0.5 mg + Berodual®.|4 hours|Per protocol population: defined as number of patients who did not present any major deviations from protocol and received at least one dose of investigational study drug.||Cost in US Dollars||Full Range|Mean
740650|NCT00460577|Secondary|Safety Assessed by: Pulse Oxymetry, Clinical Assessments, Adverse Events|Not posted: see comment in Limitations and Caveats.|4 hours||||||
740651|NCT00460577|Primary|Mean Change in Maximum Expiratory Flow From Baseline to Final Evaluation|Mean Change from Baseline to Final Evaluation in the Per Protocol population assessed by Maximum Expiratory Flow.|Baseline,4 hours|Per protocol population: defined as number of patients who did not present any major deviations from protocol and received at least one dose of investigational study drug.||Liters/minute||Standard Deviation|Mean
740658|NCT00460603|Secondary|Clearance (CL) For Bevacizumab: Phase 1|CL is a quantitative measure of the rate at which a drug substance is removed from the body. PK parameters of bevacizumab were combined for Cohorts 1, 2, and 3. CL for bevacizumab in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data.|Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.||L/hr||95% Confidence Interval|Geometric Mean
740659|NCT00460603|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) For Bevacizumab: Phase 1||Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK assessments were done only for cohort 1 to 5, as per planned analysis. Results for Cmin are not reported because Cmin could not be assessed from the data obtained from the study.|||||
740652|NCT00460603|Secondary|Change From Baseline in M.D. Anderson Symptom Assessment Inventory - Diarrhea (MDASI-D) Symptom Severity and Interference Subscale Scores at Day 1 of Cycle 2 Through Day 1 Cycle 42 and Follow-up: Phase 2|PROs included assessment of symptom severity and interference which were measured using M.D. Anderson Symptom Assessment Inventory-Diarrhea (MDASI-D), 20-item questionnaire which assesses the severity of 14 symptoms over the past 24 hours, as well as symptoms interference with 6 areas of function (e.g., walking, work, mood), when the symptom was “at its worst”. Each item is scored from 0 to 10, with ‘0’ indicating that the symptom was either not present or did not interfere with their activities, and ‘10’ indicating that the symptom was “as bad as you can imagine” or “interfered completely” with their life. The 2 subscales, symptom severity score and symptom interference score were average of respective items and ranged from 0 to 10, higher score indicating greater severity or interference of symptoms.|Cycle 1 Day 1 (baseline), every 2 weeks for the first 2 months (Cycle 2 Day 1 [C2D1], Cycle 3 Day 1, and Cycle 4 Day 1) then monthly thereafter starting Cycle 6 Day 1, and 28 days after the last dose|ITT population included all randomized participants, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.||units on scale||Standard Deviation|Mean
740653|NCT00460603|Secondary|Overall Survival (OS): Phase 2|Time in days from randomization date to date of death due to any cause. OS was calculated as the death date minus the date of first dose of study medication plus 1. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Every 3 months after discontinuation of study treatment until death due to any cause or 1 year after randomization of the last participant|ITT population included all randomized participants , with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.||days||95% Confidence Interval|Median
740654|NCT00460603|Secondary|Time to Treatment Failure (TTF): Phase 2|TTF is defined as the time from the randomization to the date of the first documentation of PD, symptomatic deterioration, death due to any cause, or treatment discontinuation due to adverse event, refusal or other reasons. Progression: >=20% increase in sum of LD of target lesions taking as references the smallest sum LD recorded since treatment start, unequivocal progression of existing nontarget lesions, or appearance of new lesions, occurrence of pleural effusion/ascites, substantiated by cytologic investigation.|Baseline (Phase 2) until disease progression, assessed every 6 weeks up to Week 148 (Phase 2) or follow-up (every 6 weeks after last dose of study drug until progression or start of alternate therapy)|ITT population included all randomized participants, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.||days||95% Confidence Interval|Median
740655|NCT00460603|Secondary|Progression-Free Survival (PFS): Phase 2|"Time in days from date of randomization to first documentation of objective tumor progression or death due to any cause. PFS was calculated as first event date minus the date of first dose of study medication plus 1. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death). Progression: >=20% increase in sum of LD of target lesions taking as references the smallest sum LD recorded since treatment start, unequivocal progression of existing nontarget lesions, or appearance of new lesions, occurrence of pleural effusion/ascites, substantiated by cytologic investigation."|Baseline (Phase 2) until disease progression, assessed every 6 weeks up to Week 148 (Phase 2) or follow-up (every 6 weeks after last dose of study drug until progression or start of alternate therapy)|ITT population included all randomized participants, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.||days||95% Confidence Interval|Median
740656|NCT00460603|Secondary|Duration of Response (DR): Phase 2|Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1. DR was calculated for the subgroup of participants with a confirmed objective tumor response. CR: disappearance of all lesions and no appearance of new lesions. PR: >=30% decrease in sum of LD of target lesions taking as reference the baseline sum LD, without progression of nontarget lesions and no appearance of new lesions. Progression: >=20% increase in sum of LD of target lesions taking as references the smallest sum LD recorded since treatment start, unequivocal progression of existing nontarget lesions, or appearance of new lesions, occurrence of pleural effusion/ascites, substantiated by cytologic investigation.|Baseline (Phase 2) until disease progression, assessed every 6 weeks up to Week 148 (Phase 2) or follow-up (every 6 weeks after last dose of study drug until progression or start of alternate therapy)|ITT population included all randomized participants, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized. 'N' (Number of participants analyzed)= those participants who were evaluable for this measure.||days||95% Confidence Interval|Median
740657|NCT00460603|Secondary|Plasma Decay Half-Life (t1/2) For Bevacizumab: Phase 1|Plasma decay half-life (t1/2) is the time measured for the plasma concentration to decrease by one half. PK parameters of bevacizumab were combined for Cohorts 1, 2, and 3. t1/2 for bevacizumab in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data.|Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.||hours||Standard Deviation|Mean
740694|NCT00460655|Secondary|Mean Change From Baseline in the Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Physiotherapist/Occupational Therapist From Baseline to Week 12 of the Double-blind Phase|The CGI of functional disability was assessed at each visit using the 11-point Numeric Rating Scale (NRS) (-5=Worst Possible to 5=Best Possible) at each time point in the double-blind phase|Baseline; Weeks 1, 4, 6, 8, and 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score||Points on a scale||Standard Deviation|Mean
740660|NCT00460603|Secondary|Maximum Observed Plasma Concentration (Cmax) For Bevacizumab: Phase 1|PK parameters of bevacizumab were combined for Cohorts 1, 2, and 3. Cmax for bevacizumab in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. The bevacizumab pharmacokinetic parameters were normalized to 1 mg/kg dose.|Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.||ng/mL||95% Confidence Interval|Geometric Mean
740661|NCT00460603|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] For Bevacizumab: Phase 1|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It was obtained from AUC (0 - t) plus AUC (t - ∞). PK parameters of bevacizumab were combined for Cohorts 1, 2, and 3. AUC (0 - ∞) for bevacizumab in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. The bevacizumab pharmacokinetic parameters were normalized to 1 mg/kg dose.|Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.||ng*hr/mL||95% Confidence Interval|Geometric Mean
740662|NCT00460603|Secondary|Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) For Bevacizumab: Phase 1|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). PK parameters of bevacizumab were combined for Cohorts 1, 2, and 3. AUClast for bevacizumab in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. The bevacizumab pharmacokinetic parameters were normalized to 1 mg/kg dose.|Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.||ng*hr/mL||95% Confidence Interval|Geometric Mean
740663|NCT00460603|Secondary|Plasma Decay Half-Life (t1/2) For Irinotecan: Phase 1|Plasma decay half-life (t1/2) is the time measured for the plasma concentration to decrease by one half. t1/2 for irinotecan in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data.|Predose, 1, 2, 2.5, 4, 6, 8, 24 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.||hours||Standard Deviation|Mean
740664|NCT00460603|Secondary|Clearance (CL) For Irinotecan: Phase 1|CL is a quantitative measure of the rate at which a drug substance is removed from the body. CL for irinotecan in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data.|Predose, 1, 2, 2.5, 4, 6, 8, 24 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.||L/hr||95% Confidence Interval|Geometric Mean
740665|NCT00460603|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) For Irinotecan: Phase 1||Predose, 1, 2, 2.5, 4, 6, 8, 24 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK assessments were done only for cohort 1 to 5, as per planned analysis. Results for Cmin are not reported because Cmin could not be assessed from the data obtained from the study.|||||
740666|NCT00460603|Secondary|Maximum Observed Plasma Concentration (Cmax) For Irinotecan: Phase 1|Cmax for irinotecan in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 irinotecan dose.|Predose, 1, 2, 2.5, 4, 6, 8, 24 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.||ng/mL||95% Confidence Interval|Geometric Mean
740667|NCT00460603|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] For Irinotecan: Phase 1|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It was obtained from AUC (0 - t) plus AUC (t - ∞). AUC (0 - ∞) for irinotecan in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 irinotecan dose.|Predose, 1, 2, 2.5, 4, 6, 8, 24 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.||ng*hr/mL||95% Confidence Interval|Geometric Mean
740668|NCT00460603|Secondary|Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) For Irinotecan: Phase 1|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). AUClast for irinotecan in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 irinotecan dose.|Predose, 1, 2, 2.5, 4, 6, 8, 24 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.||ng*hr/mL||95% Confidence Interval|Geometric Mean
740669|NCT00460603|Secondary|Plasma Decay Half-Life (t1/2) For 5-Fluorouracil: Phase 1|Plasma decay half-life (t1/2) is the time measured for the plasma concentration to decrease by one half. PK parameters of 5-FU were combined for Cohorts 1, 2, and 3. t1/2 for 5-FU in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data.|Pre-5-FU bolus, 5 min (post-5-FU bolus), 0.25, 0.5, 0.75, 2, 4, 6, 22, 34-46 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.||hours||Standard Deviation|Mean
740670|NCT00460603|Secondary|Clearance (CL) For 5-Fluorouracil: Phase 1|CL is a quantitative measure of the rate at which a drug substance is removed from the body. PK parameters of 5-FU were combined for Cohorts 1, 2, and 3. CL for 5-FU in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data.|Pre-5-FU bolus, 5 min (post-5-FU bolus), 0.25, 0.5, 0.75, 2, 4, 6, 22, 34-46 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.||L/hr||95% Confidence Interval|Geometric Mean
740671|NCT00460603|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) For 5-Fluorouracil: Phase 1||Pre-5-FU bolus, 5 min (post-5-FU bolus), 0.25, 0.5, 0.75, 2, 4, 6, 22, 34-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK assessments were done only for cohort 1 to 5, as per planned analysis. Results for Cmin are not reported because Cmin could not be assessed from the data obtained from the study.|||||
740672|NCT00460603|Secondary|Maximum Observed Plasma Concentration (Cmax) For 5-Fluorouracil: Phase 1|PK parameters of 5-FU were combined for Cohorts 1, 2, and 3. Cmax for 5-FU in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 5-FU dose.|Pre-5-FU bolus, 5 min (post-5-FU bolus), 0.25, 0.5, 0.75, 2, 4, 6, 22, 34-46 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.||ng/mL||95% Confidence Interval|Geometric Mean
740673|NCT00460603|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] For 5-Fluorouracil: Phase 1|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It was obtained from AUC (0 - t) plus AUC (t - ∞). PK parameters of 5-FU were combined for Cohorts 1, 2, and 3. AUC (0 - ∞) for 5-FU in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 5-FU dose.|Pre-5-FU bolus, 5 min (post-5-FU bolus), 0.25, 0.5, 0.75, 2, 4, 6, 22, 34-46 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.||ng*hr/mL||95% Confidence Interval|Geometric Mean
740674|NCT00460603|Secondary|Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) For 5-Fluorouracil: Phase 1|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). PK parameters of 5-FU were combined for Cohorts 1, 2, and 3. AUClast for 5-FU in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 5-FU dose.|Pre-5-FU bolus, 5 min (post-5-FU bolus), 0.25, 0.5, 0.75, 2, 4, 6, 22, 34-46 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.||ng*hr/mL||95% Confidence Interval|Geometric Mean
740675|NCT00460603|Secondary|Plasma Decay Half-Life (t1/2) For Oxaliplatin: Phase 1|Plasma decay half-life (t1/2) is the time measured for the plasma concentration to decrease by one half. PK parameters of oxaliplatin, assessed by estimating total platinum in plasma ultrafiltrate, were combined for Cohorts 1, 2, and 3. t1/2 for oxaliplatin in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data.|Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.||hours||Standard Deviation|Mean
740676|NCT00460603|Secondary|Clearance (CL) For Oxaliplatin: Phase 1|CL is a quantitative measure of the rate at which a drug substance is removed from the body. PK parameters of oxaliplatin, assessed by estimating total platinum in plasma ultrafiltrate, were combined for Cohorts 1, 2, and 3. CL for oxaliplatin in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data.|Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.||L/hr||95% Confidence Interval|Geometric Mean
740677|NCT00460603|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) For Oxaliplatin: Phase 1||Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK assessments were done only for cohort 1 to 5, as per planned analysis. Results for Cmin are not reported because Cmin could not be assessed from the data obtained from the study.|||||
740723|NCT00466310|Primary|Total Plasmalogen Levels in the Lipid Profile|Plasmalogens are a subclass of glycerophospholipids and ubiquitous constituents of cellular membranes and serum lipoproteins. Several neurological disorders show decreased level of plasmalogens.|Baseline|17 of the 31 available controls were age and BMI matched to the schizophrenia subjects.||nmoles/gram||Standard Deviation|Mean
740678|NCT00460603|Secondary|Maximum Observed Plasma Concentration (Cmax) For Oxaliplatin: Phase 1|PK parameters of oxaliplatin, assessed by estimating total platinum in plasma ultrafiltrate, were combined for Cohorts 1, 2, and 3. Cmax for oxaliplatin in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 oxaliplatin dose.|Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.||ng/mL||95% Confidence Interval|Geometric Mean
740679|NCT00460603|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] For Oxaliplatin: Phase 1|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It was obtained from AUC (0 - t) plus AUC (t - ∞). PK parameters of oxaliplatin, assessed by estimating total platinum in plasma ultrafiltrate, were combined for Cohorts 1, 2, and 3. AUC (0 - ∞) for oxaliplatin in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 oxaliplatin dose.|Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.||ng*hr/mL||95% Confidence Interval|Geometric Mean
740680|NCT00460603|Secondary|Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) For Oxaliplatin: Phase 1|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). PK parameters of oxaliplatin, assessed by estimating total platinum in plasma ultrafiltrate, were combined for Cohorts 1, 2, and 3. AUClast for oxaliplatin in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 oxaliplatin dose.|Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.||ng*hr/mL||95% Confidence Interval|Geometric Mean
740681|NCT00460603|Secondary|Plasma Decay Half-Life (t1/2) For Axitinib: Phase 1|Plasma decay half-life (t1/2) is the time measured for the plasma concentration to decrease by one half. PK parameters of axitinib (AG-013736) were combined for Cohorts 1, 2, and 3. t1/2 for axitinib in absence of bevacizumab + FOLFOX was estimated from Cycle 1 Day 8 data and in presence of bevacizumab + FOLFOX was estimated from Cycle 2 Day 1 data.|Predose, 1, 2, 2.5, 4, 6, 8 hours postdose on Cycle 1 Day 8, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.||hours||Standard Deviation|Mean
740682|NCT00460603|Secondary|Apparent Oral Clearance (CL/F) For Axitinib: Phase 1|Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed (F). Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. PK parameters of axitinib (AG-013736) were combined for Cohorts 1, 2, and 3. CL/F for axitinib (AG-013736) in absence of bevacizumab + FOLFOX was estimated from Cycle 1 Day 8 data and in presence of bevacizumab + FOLFOX was estimated from Cycle 2 Day 1 data.|Predose, 1, 2, 2.5, 4, 6, 8 hours postdose on Cycle 1 Day 8, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.||Liter per hour (L/hr)||95% Confidence Interval|Geometric Mean
740683|NCT00460603|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) For Axitinib: Phase 1||Predose, 1, 2, 2.5, 4, 6, 8 hours postdose on Cycle 1 Day 8, Cycle 2 Day 1|PK assessments were done only for cohort 1 to 5, as per planned analysis. Results for Cmin are not reported because Cmin could not be assessed from the data obtained from the study.|||||
740684|NCT00460603|Secondary|Maximum Observed Plasma Concentration (Cmax) For Axitinib: Phase 1|PK parameters of axitinib (AG-013736) were combined for Cohorts 1, 2, and 3.Cmax for axitinib (AG-013736) in absence of bevacizumab + FOLFOX was estimated from Cycle 1 Day 8 data and in presence of bevacizumab + FOLFOX was estimated from Cycle 2 Day 1 data. Results were normalized to axitinib 5 mg dose.|Predose, 1, 2, 2.5, 4, 6, 8 hours postdose on Cycle 1 Day 8, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.||ng/mL||95% Confidence Interval|Geometric Mean
740685|NCT00460603|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] For Axitinib: Phase 1|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It was obtained from AUC (0 - t) plus AUC (t - ∞). PK parameters of axitinib (AG-013736) were combined for Cohorts 1, 2, and 3. AUC (t - ∞] for axitinib in absence of bevacizumab + FOLFOX was estimated from Cycle 1 Day 8 data and in presence of bevacizumab + FOLFOX was estimated from Cycle 2 Day 1 data. Results were normalized to axitinib 5 mg dose.|Predose, 1, 2, 2.5, 4, 6, 8 hours postdose on Cycle 1 Day 8, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.||ng*hr/mL||95% Confidence Interval|Geometric Mean
740724|NCT00466323|Primary|Family-Clinician Contact (Not Including Notes From FMPO Clinicians)|Chart review looking at the any clinician contact with veteran's family members|Within 6 months of intervention|We enrolled (consented and baseline) 238 individuals. Over the course of the study, we withdrew 6 individuals. We only conducted analysis on the 232 remaining individuals.||Number of Interactions||Standard Deviation|Mean
740686|NCT00460603|Secondary|Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) For Axitinib: Phase 1|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). Pharmacokinetic (PK) parameters of axitinib (AG-013736) were combined for Cohorts 1, 2, and 3. AUClast for axitinib in absence of bevacizumab + FOLFOX was estimated from Cycle 1 Day 8 data and in presence of bevacizumab + FOLFOX was estimated from Cycle 2 Day 1 data. Results were normalized to axitinib 5 mg dose.|Predose, 1, 2, 2.5, 4, 6 and 8 hours postdose on Cycle 1 Day 8, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.||nanogram hour per milliliter (ng*hr/mL)||95% Confidence Interval|Geometric Mean
740687|NCT00460603|Primary|Percentage of Participants With Objective Response: Phase 2|Percentage of participants with objective response (OR) based assessment of confirmed complete response(CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all lesions and no appearance of new lesions. Confirmed PR defined as >=30 percent (%) decrease in sum of the longest dimensions (LD) of the target lesions taking as reference the baseline sum LD , without progression of nontarget lesions and no appearance of new lesions. Confirmed responses are those that persist on repeat imaging study >=4 weeks after initial documentation of response.|Baseline (Phase 2) until disease progression, assessed every 6 weeks up to Week 148 (Phase 2) or follow-up (every 6 weeks after last dose of study drug until progression or start of alternate therapy)|Intent-to-treat (ITT) population included all randomized participants, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.||Percentage of participants||95% Confidence Interval|Number
740688|NCT00460655|Secondary|Mean Change From Baseline (at the Start of the DB Phase) in the Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Physiotherapist/Occupational Therapist at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase|The CGI of functional disability was assessed at each visit using the 11-point Numeric Rating Scale (NRS) (-5=Worst Possible to 5=Best Possible) at each time point from baseline (at the start of the double-blind phase) to Week 48.|Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score||Points on a scale||Standard Deviation|Mean
740689|NCT00460655|Secondary|Mean Change From Baseline (at the Start of the Double-blind Phase) in the Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Participant at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase|The CGI of functional disability was assessed at each visit using the 11-point Numeric Rating Scale (NRS) (-5=Worst Possible to 5=Best Possible) at each time point from baseline (at the start of the double-blind phase) to Week 48.|Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score||Points on a scale||Standard Deviation|Mean
740690|NCT00460655|Secondary|Mean Change From Baseline (at the Start of the Double-blind Phase) in the Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Investigator at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase|The CGI of functional disability was assessed at each visit using the 11-point Numeric Rating Scale (NRS) (-5=Worst Possible to 5=Best Possible) at each time point from baseline (at the start of the double-blind phase) to Week 48.|Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score||Points on a scale||Standard Deviation|Mean
740691|NCT00460655|Secondary|Mean Change From Baseline (at the Start of the Double-blind Phase) in the Time (Seconds) to Walk 10 Meters at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase|The time (seconds) required to walk 10 meters was measured at each time point from baseline (at the start of the double-blind phase) to Week 48.|Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score||seconds||Standard Deviation|Mean
740692|NCT00460655|Secondary|Mean Change From Baseline (at the Start of the Double-blind Phase) in the Physician's Rating Score (PRS) at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase|The investigator assessed the PRS of gait pattern consisting of 3 parameters. Affected limb was scored on a scale of -1 (worst) to 9 (best) based on 3 parameters (initial foot contact, foot contact at midstance, gait assistive devices) at each time point from baseline (at the start of the double-blind phase) to Week 48.|Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score||Points on a scale||Standard Deviation|Mean
740693|NCT00460655|Secondary|Mean Change From Baseline (at the Start of the Double-blind Phase) in the MAS Ankle Score at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase|The investigator assessed Modified Ashworth Scale (MAS) ankle score using a 6-point scale (0, 1, 1+, 2, 3, and 4; 0=No increase in muscle tone to 4=Affected part[s] rigid in flexion or extension) at each time point from baseline (at the start of the double-blind phase) to Week 48. The “+1” (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder [less than half] of ROM [range of motion]) of MAS score is regarded as score 1.5.|Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score||Points on a scale||Standard Deviation|Mean
740776|NCT00472797|Secondary|Tolerability in Pain Using Visual Analog Scale (VAS)|The SF-MPQ included a visual analog scale, ranging from 0 to 100 mm, on which subjects rate pain from no pain (0 mm) to worst possible pain (100 mm). A rating of <5 mm was considered pain-free.|Baseline to Week 12|ITT||Participants|||Number
740695|NCT00460655|Secondary|Mean Change From Baseline in the Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Participant From Baseline to Week 12 of the Double-blind Phase|The CGI of functional disability was assessed at each visit using the 11-point Numeric Rating Scale (NRS) (-5=Worst Possible to 5=Best Possible) at each time point in the double-blind phase|Baseline; Weeks 1, 4, 6, 8, and 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score||Points on a scale||Standard Deviation|Mean
740696|NCT00460655|Secondary|Mean Change From Baseline in the Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Investigator From Baseline to Week 12 of the Double-blind Phase|The CGI of functional disability was assessed at each visit using the 11-point Numeric Rating Scale (NRS) (-5=Worst Possible to 5=Best Possible) at each time point in the double-blind phase.|Baseline; Weeks 1, 4, 6, 8, and 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score||Points on a scale||Standard Deviation|Mean
740697|NCT00460655|Secondary|Mean Change From Baseline in the Time (Seconds) to Walk 10 Meters From Baseline to Week 12 of the Double-blind Phase|The time (seconds) required to walk 10 meters was measured at each time point in the double-blind phase.|Baseline; Weeks 1, 4, 6, 8, and 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score||seconds||Standard Deviation|Mean
740698|NCT00460655|Secondary|Mean Change From Baseline in the Physician's Rating Score (PRS) From Baseline to Week 12 of the Double-blind Phase|The investigator assessed the PRS of gait pattern consisting of 3 parameters. Affected limb was scored on a scale of -1 (worst) to 9 (best) based on 3 parameters (initial foot contact, foot contact at midstance, gait assistive devices) at each time point in double-blind phase.|Baseline; Weeks 1, 4, 6, 8, and 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score||Points on a scale||Standard Deviation|Mean
740699|NCT00460655|Secondary|Mean Change From Baseline in the MAS Ankle Score From Baseline to Week 12 of the Double-blind Phase|The investigator assessed Modified Ashworth Scale (MAS) ankle score using a 6-point scale (0, 1, 1+, 2, 3, and 4; 0=No increase in muscle tone to 4=Affected part[s] rigid in flexion or extension) at each time point in the double-blind phase. The “+1” (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder [less than half] of ROM [range of motion]) of MAS score is regarded as score 1.5.|Baseline; Weeks 1, 4, 6, 8, and 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score||Points on a scale||Standard Deviation|Mean
740700|NCT00460655|Primary|Area Under the Curve (AUC) for the Change From Baseline in Modified Ashworth Scale (MAS) Ankle Score to the End of the DB Phase (Week 12)|Change from baseline in MAS ankle score using a 6-point scale (0, 1, 1+ [regarded as 1.5], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part[s] rigid in flexion/extension) to each time point in the DB phase was calculated. In the graph plotting time points on the horizontal axis and changes from baseline on the vertical axis, the area surrounded by the MAS ankle score change curve and the horizontal axis was calculated and used as a summary index (AUC) for assessment of the MAS ankle score. Negative changes from baseline indicate improvement, and the AUC has a negative sign.|Baseline, Week 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score||Score*week||Standard Deviation|Mean
740701|NCT00460746|Secondary|Median Change From Baseline in Glucose at Week 48.||Week 48|ITT , LOCF.||mg/dL||Full Range|Median
740702|NCT00460746|Secondary|Median Change From Baseline in Total Cholesterol (TC) / High Denisty Lipoprotein (HDL) Ratio at Week 48.||Week 48|ITT , LOCF.||ratio of TC and HDL||Full Range|Median
740703|NCT00460746|Secondary|Median Change From Baseline in HDL Cholesterol.||Week 48|ITT , LOCF.||mg/dL||Full Range|Median
740704|NCT00460746|Secondary|Median Change From Baseline in LDL Cholesterol at Week 48.||Week 48|ITT , LOCF.||mg/dL||Full Range|Median
740705|NCT00460746|Secondary|Median Change From Baseline in Total Cholesterol at Week 48.||Week 48|ITT , LOCF.||mg/dL||Full Range|Median
740706|NCT00460746|Secondary|Median Change From Baseline in Triglycerides at Week 48.||Week 48|ITT , LOCF.||mg/dL||Full Range|Median
740707|NCT00460746|Secondary|CD4+ Cell Count (x 10^6 Cell/L): Baseline and Mean Changes From Baseline at 4, 8, 12, 16, 24,36 and 48 Weeks.||Week 48|ITT , LOCF.||cells/mm^3||Standard Deviation|Mean
740708|NCT00460746|Secondary|CD4+ Cell Count (x 10^6 Cell/L): Baseline and Median Changes From Baseline at 4, 8, 12, 16, 24, 36 and 48 Weeks.||Week 48|Intent To Treat (ITT), last observation carried forward (LOCF).||cells/mm^3||Full Range|Median
740709|NCT00460746|Secondary|Proportion of Patients Who Have Viral Load Measurements <50 Copies/ml at 2, 4, 8, 12, 16, 24, 36 and 48 Weeks After Switching to DRV/r and ETR, Missing Equals Failure.||48 weeks|ITT population. One subject (001) who discontinued due to adverse events had a VL < 50 copies/mL at Week 4. Another subject (013) who was lost to follow-up had VL <50 copies/mL through Week 36.||percentage of participants|||Number
740710|NCT00460746|Primary|Proportion of Patients Who Maintain Plasma HIV Viral Load Measurements < 400 Copies/ml at 2, 4, 8, 12, 16, 24, 36 and 48 Weeks After Switching to DRV/r and ETR, Missing Equals Failure.||48 weeks|ITT population. One subject (001) who discontinued due to adverse events had a VL < 50 copies/mL at Week 4. Another subject (013) who was lost to follow-up had VL <50 copies/mL through Week 36.||percentage of participants|||Number
740711|NCT00460798|Primary|European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Scores|EORTC QLQ-C30: 5 functional scales (physical, role, cognitive, emotional, and social), a global health status/quality of life (QoL) scale, 3 symptom scales (nausea and vomiting, pain, fatigue) and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties). All scales and single-item measures range=0 to 100. High score for a functional scale=high/healthy level of functioning. High score for global health status/QoL=high QoL. High score for symptom scale/single item=high level of symptomatology/problems|Baseline, 3, 6, 9 and 12 Months|FAS. n=number of participants with EORTC scale score data available at each specified time point||Scores on Scale||Standard Deviation|Mean
740712|NCT00460798|Primary|Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status|ECOG performance status measured on 6 point scale to assess participant's performance status. 0=Fully active, able to carry on all pre-disease activities without restriction; 1=Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; 2=Ambulatory (>50% of waking hours), capable of all self care, unable to carry out any work activities; 3=Capable of only limited self care, confined to bed/chair >50% of waking hours; 4=Completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=Dead. 0=Best status, 5=Worst status|Baseline, 3, 6, 9 and 12 Months|FAS. ECOG performance status data was not reported for 24, 32, 96, 174, and 174 participants at baseline, 3, 6, 9, and 12 months, respectively.||Participants|||Number
740713|NCT00460798|Primary|Time to Progression (TTP)|TTP = time from date of first dose to date of first recording of PD. Participants who did not have a recorded PD at any of the visits or at Overall Objective Tumor Assessment at 12 months were treated as censored at the date of the last available follow up for disease response/tumor assessment.|Start of Treatment up through 12 Months or Early Discontinuation|FAS. Number of participants with progression = 162; Number of participants censored = 190||Months||95% Confidence Interval|Median
740714|NCT00460798|Primary|Number of Participants With Objective Response|Objective response (CR or PR) based on investigator's overall objective tumor assessment at final visit according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as disappearance of all target lesions. PR was defined as a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|12 Months or Early Discontinuation|FAS||Participants|||Number
740715|NCT00460798|Primary|Number of Participants With Categorical Best Overall Response|Best overall reponse based on investigator's disease status assessment. Complete response(CR)=disappearance of all target lesions.Partial Response(PR)=≥30% decrease in sum of longest dimensions of lesions taking as reference baseline sum longest dimensions.Progressive disease(PD)=≥20% increase in sum of longest dimensions of lesions taking as a reference smallest sum of longest dimensions since treatment start or appearance of ≥1 new lesions. Stable disease(SD)=neither shrinkage for PR or increase for PD taking as reference smallest sum of longest dimensions since treatment start.|Start of Treatment up through 12 Months or Early Discontinuation|Full Analysis Set (FAS) = All participants who had taken at least 1 dose of study medication and had a post baseline efficacy measurement||Participants|||Number
740716|NCT00460811|Secondary|Change From Baseline in Abdominal Pain (5-point Ordinal Scale) for the Treatment Period|During the study, patients provided their self assessment of abdominal pain using a 5-point ordinal scale (1=none, 2=mild, 3=moderate, 4=severe, 5=very severe|Change from Baseline to Week 12|The ITT Population included 419 patients of the Safety Population who also had ≥ 1 post-dose evaluation of the primary efficacy assessment (i.e., CSBM Frequency).||units on a scale||Standard Error|Least Squares Mean
740717|NCT00460811|Secondary|Change From Baseline in Degree of Relief of Irritable Bowel Syndrome (IBS) Symptoms (7-point Balanced Scale) for the Treatment Period|Patients provided a weekly assessment of Degree of Relief of IBS Symptoms using a 7-point balanced scale (1=completely relieved, 2=considerably relieved, 3=somewhat relieved, 4=unchanged, 5=somewhat worse, 6=considerably worse, 7=as bad as I can imagine).|Change from Baseline to Week 12|The ITT Population included 419 patients of the Safety Population who also had ≥ 1 post-dose evaluation of the primary efficacy assessment (i.e., CSBM Frequency). 13 patients who dropped out prior to finishing 1 week of the trial have missing data.||units on a scale||Standard Error|Least Squares Mean
740718|NCT00460811|Secondary|Change From Baseline in Straining (5-point Ordinal Scale) for the Treatment Period|Straining was assessed using a 5-point ordinal scale, whereby a score of 1 = not at all, 2 = a little bit, 3 = a moderate amount, 4 = a great deal, and 5 = an extreme amount.|Change from Baseline to Week 12|The ITT Population included 419 patients of the Safety Population who also had ≥ 1 post-dose evaluation of the primary efficacy assessment (i.e., CSBM Frequency). 15 patients with no pretreatment spontaneous bowel movements were excluded from the Straining analysis.||units on a scale||Standard Error|Least Squares Mean
740719|NCT00460811|Secondary|Change From Baseline in Stool Consistency (7-point Ordinal BSFS) for the Treatment Period|Stool consistency analyses were performed using the 7-point Bristol Stool Form Scale (BSFS), whereby a score of 1 = separate hard lumps like nuts (difficult to pass); 2 = sausage shaped but lumpy; 3 = like a sausage but with cracks on surface; 4 = like a sausage or snake, smooth and soft; 5 = soft blobs with clear-cut edges (passed easily); 6 = fluffy pieces with ragged edges, a mushy stool; and 7 = watery, no solid pieces (entirely liquid).|Change from Baseline to Week 12|The ITT Population included 419 patients of the Safety Population who also had ≥ 1 post-dose evaluation of the primary efficacy assessment (i.e., CSBM Frequency). 15 patients with no pretreatment spontaneous bowel movements were excluded from the Stool Consistency analysis.||units on a scale||Standard Error|Least Squares Mean
740720|NCT00460811|Secondary|Change From Baseline in the Weekly Normalized SBM Rate for the Treatment Period|SBMs were measured daily during the treatment period by patient calls to the IVRS.|Change from Baseline to Week 12|The ITT Population included 419 patients of the Safety Population who also had ≥ 1 post-dose evaluation of the primary efficacy assessment (i.e., CSBM Frequency).||SBMs per week||Standard Error|Least Squares Mean
740721|NCT00460811|Secondary|CSBM 75% Responder for the Treatment Period (Based on the Normalized Rate)|For each week of the Treatment and Posttreatment Periods, a patient was considered a CSBM Responder if for that week the patient 1) completed ≥ 4 days of IVRS questions, 2) had a CSBM rate of ≥ 3 for the week, and 3) had an increase in CSBM rate of ≥ 1 from the baseline weekly CSBM rate.|Change from Baseline to Week 12|The ITT Population included 419 patients of the Safety Population who also had ≥ 1 post-dose evaluation of the primary efficacy assessment (i.e., CSBM Frequency).||participants|||Number
740722|NCT00460811|Primary|Change From Baseline in the Weekly Normalized Complete Spontaneous Bowel Movement (CSBM) Rate During Weeks 1 Through 12 of the Treatment Period|"The change in the weekly normalized CSBM Rate during Weeks 1 through 12 of the Treatment Period from the weekly normalized CSBM Rate obtained during the Pretreatment Period.
The CSBM rate was normalized based on the number of CSBMs occurring in that week, adjusting for differences in the duration of the week and black-out periods (time not covered due to a missed IVRS call) versus 7x24 hours."|Change from Baseline to Week 12|The Intent-to-treat (ITT) Population included 419 patients of the Safety Population who also had ≥ 1 post-dose evaluation of the primary efficacy assessment (i.e., CSBM Frequency)||CSBMs per week||Standard Error|Least Squares Mean
740725|NCT00466323|Secondary|Consumer's Recovery Rating - MHRM - Overcoming Stuckness Sub Score|We measured recovery attitudes and beliefs with the Mental Health Recovery Measure (MHRM), a 30-item self-report measure that has a total score and eight subscales. This sub score is Overcoming Stuckness.The MHRM sub scales range from 0-16, with a higher score indicating better recovery.|Within 6 month of the intervention|We enrolled (consented and baseline) 238 individuals. Over the course of the study, we withdrew 6 individuals. We only conducted analysis on the 232 remaining individuals.||units on a scale||Standard Deviation|Mean
740726|NCT00466323|Secondary|Consumer's Recovery Rating - MHRM Total Score|We measured recovery attitudes and beliefs with the Mental Health Recovery Measure (MHRM), a 30-item self-report measure that has a total score and eight subscales.The MHRM scales range from 0-120, with a higher score indicating better recovery.|Within 6 months of intervention|We enrolled (consented and baseline) 238 individuals. Over the course of the study, we withdrew 6 individuals. We only conducted analysis on the 232 remaining individuals.||Units on a Scale||Standard Deviation|Mean
740727|NCT00466323|Primary|Family-Clinician Contact (Including Contact With FMPO Clinician)|Chart review looking at the any clinician contact with veteran's family members|Within 6 months of intervention|We enrolled (consented and baseline) 238 individuals. Over the course of the study, we withdrew 6 individuals. We only conducted analysis on the 232 remaining individuals.||Number of Interactions||Standard Deviation|Mean
740728|NCT00466505|Secondary|Serum TGF-alpha: Treatment Cycle 2|Measurement in ng/mL of tumor growth factor-alpha (TGF-alpha) in serum samples during treatment cycle 2|on-study week 9|||ng/mL||Standard Deviation|Mean
740729|NCT00466505|Secondary|Urinary PGE-M : Treatment Cycle 2|Measurement in ng/mL of a stable metabolite of prostaglandin E2 (PGE-M) in urine during treatment cycle 2|on-study week 9|||ng/mL||Standard Deviation|Mean
740730|NCT00466505|Secondary|Serum TGF-alpha: Treatment Cycle 1|Measurement in ng/mL of tumor growth factor-alpha (TGF-alpha) in serum samples during treatment cycle 1|on-study week 5|||ng/mL||Standard Deviation|Mean
740731|NCT00466505|Secondary|Urinary PGE-M : Treatment Cycle 1|Measurement in ng/mL of a stable metabolite of prostaglandin E2 (PGE-M) in urine during treatment cycle 1|on-study week 5|||ng/mL||Standard Deviation|Mean
740732|NCT00466505|Secondary|Number of Patients With Each Worst-grade Toxicity Response|Number of patients with worst-grade toxicity response of each grade (grade 1 to 5) following NCI Common Toxicity Criteria, with grade 1=mild adverse event; 2=moderate adverse event; 3=severe and undesirable adverse event; 4=life-threatening or disabling adverse event; 5=death.|On study date to off study date in this study with median 9.76 months|||patients|||Number
740733|NCT00466505|Secondary|One Year Survival Rate|Percent of patients who remain alive one year from on-study date|1 year from on-study date|||Percentage of participants||95% Confidence Interval|Number
740734|NCT00466505|Secondary|Overall Survival|Median survival time in months, from on-study date to date of death|On study date to off study date in this study with median 9.76 months|||Months||Inter-Quartile Range|Median
740735|NCT00466505|Secondary|Patient Response to Treatment|Number of patients in each response category according to RECIST criteria: Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.|On study date to off study date in this study with median 9.76 months|||participants|||Number
740736|NCT00466505|Primary|Progression-free Survival (PFS)|Number of days from study enrollment to evidence of progressive disease radiographically, with progression defined under RECIST criteria as at least 20% increase in sum of longest diameter of target lesions|On study date to off study date in this study with median 9.76 months|||Days||Full Range|Median
740737|NCT00466687|Secondary|Number of Patients With Each Worst-grade Toxicity Response|Number of patients with worst-grade toxicity at each of five grades following National Cancer Institute Common Toxicity Criteria with grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life-threatening/disabling, 5 = death.|Day 1 of each 28-day cycle for 6 cycles (168 days)|Patients who received the study drug and who experienced a toxicity. Eleven patients did not experience any toxicity and are therefore not included in the analyzed population for this outcome measure.||participants|||Number
740738|NCT00466687|Secondary|Progression-free Survival at 6 Months|Patients with Progression-free survival at 6 months|6 months|Those patients who were progression-free at 6 months from study entry. No date of progression was available for 7 patients||participants|||Number
740739|NCT00466687|Secondary|Time to Disease Progression.|Time from on study date to date of progression in months, if the progression happened in the patient. Disease progression is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions with reference to the smallest sum LD since treatment began or the appearance of one or more new lesions.|up to one year after off-study date|Patients with disease progression. Six patients were not available for determination to progression: no data (5) and toxicity (1).||Months||Full Range|Median
740740|NCT00466687|Primary|Number of Patients With Response|Per Response Evaluation Criteria in Solid Tumor (RECIST): Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.|At 6 months|Patients for whom a response could be determined. Three patients were not available for measurement of response: no data (2) and toxicity (1).||participants|||Number
740777|NCT00472797|Secondary|Total Score on Short-Form McGill Pain Questionnaire (SF-MPQ): Change in Baseline to Wk 12|The SF-MPQ assesses Tolerability of Pain with 15 questions to evaluate the type and severity of pain experienced 60 minutes after an injection of study drug. Scores range from 0 (no pain) to 45 (severe pain).|Baseline to Week 12|ITT and LOCF||score on scale||Standard Deviation|Mean
740778|NCT00472797|Secondary|Change in Score From Baseline to Week 12 for All Domains Other Than Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ)|The MSTCQ in all domains assesses quality of life. The score for all domains other than the Global Side Effect ranges from 17 (most favorable) to 85 (least favorable). Change calculated as (score at week 12 – score at baseline.|Baseline to Week 12|||score on scale||Standard Deviation|Mean
740765|NCT00466882|Secondary|Document the Occurrence of Any Adverse Events Including Infection and/or Erosion of the LAPBAND and/or Need for Surgical Revision in LAPBAND||Until recovery from transplant||||||
740766|NCT00466882|Primary|Number of Participants With BMI < 35 kg/m^2 Within 18 Months Following Weight Loss Surgery|See if successful weight loss surgery would allow patients to reduce their preoperative Body Mass Index (BMI in kg/m2) to below 35 kg/m2 within the first 18 months after weight loss surgery in order to see if these patients became eligible for kidney transplantation - most facilities require transplant candidates to have a BMI below 35 kg/m2.|18 months|||participants|||Number
740767|NCT00472576|Primary|Montgomery-Asberg Depression Rating Scale (MADRS)|The Montgomery-Asberg Depression Rating Scale (MADRS) measures the severity of depression where smaller scores indicate less depression and higher scores suggest more severe depression. Possible scores for this 10 item version range from 0 to 60. Generally, a score of 18 or greater is used to indicate a substantial depression level. The measure at the end of the study is the primary outcome.|Measured daily for 12 days, where the endpoint is the primary outcome|The number of participants includes all patients who received at least one rating after taking even a single dose of either active drug or placebo.||Score on a scale||Standard Error|Least Squares Mean
740768|NCT00472576|Secondary|Hamilton Depression Rating Scale (HDRS)|The Hamilton Depression Rating Scale (HDRS) measures the severity of depression where smaller scores indicate less depression and higher scores suggest more severe depression. Possible scores for this 17 item version range from 0 to 52. Generally, a score of 18 or greater is used to indicate a substantial depression level. The measure at the end of the study is primary.|Measured daily for 12 days, where the endpoint is primary|The number of participants includes all patients who received at least one rating after taking even a single dose of either active drug or placebo.||Score on a scale||Standard Error|Least Squares Mean
740769|NCT00472641|Secondary|Changes From Baseline to Endpoint in Body Mass Index (BMI)|Secondary outcome measures will include the change from baseline to endpoint in Body Mass Index (BMI).|Baseline, 12 weeks|||kg/m^2||Standard Deviation|Mean
740770|NCT00472641|Primary|The Primary Outcome Measure Was Weight Change From Baseline to Endpoint.|The primary outcome measure will be the change in weight from baseline to endpoint using a random regression mixed effects model.|Baseline, 12 weeks|||Pounds||Standard Deviation|Mean
740771|NCT00472732|Primary|Fractional Anisotropy|Measure of white matter integrity in OTCD Patients and Controls in frontal white matter. Fractional anisotropy values fall on a scale of 0 to 1, with 0 meaning that the diffusion of water is isotropic and unrestricted, or equally restricted, in all directions and with 1 meaning that diffusion occurs along only one axis and is fully restricted along all other directions. Scores closer to 1 are associated with intact white matter while scores closer to 0 are associated with white matter damage.|one time measurement at study baseline|Five OTCD Patients and four healthy controls were excluded due to excessive head motion.||units on a scale||Standard Deviation|Mean
740772|NCT00472732|Primary|Functional MRI Activation in N-Back Tast|"Measure of blood oxygen level dependent (BOLD) signal of OTCD patients and healthy controls during an N-Back task comparing 2-back and 1-back conditions. This contrast was created for each participant using SPM and then entered into a group analysis in which we compare percent signal change between groups. Therefore, we never see BOLD signal change at the individual level, which is why we never see scores or numbers at the individual level and we cannot calculate a measure of dispersion for this data."|one time measurement at study baseline|Five OTCD patients and one healthy control were excluded due to excessive head motion.||percent signal change|||Number
740773|NCT00472732|Primary|Concentration of Glutamine and Myoinositol by MRS|"Concentration based on area under curve on 1H MRS and quantitated by LCModel. A metabolite’s tissue concentration is related to the integrated amplitude of the MRS signal it produces. Integrated amplitude is the area under the MRS signal curve. While MRS signals are usually acquired in the time domain as free induction decays or echoes, they are usually viewed and analyzed in the frequency domain. The frequency domain representation is derived from the acquired time domain data by the Fourier Transform. The protocol we use selects 257 averages. This means, 257 free induction decays. The machine summates the data at each time point to generate one value for the area under the curve. Therefore, we don’t have the measurement at each time point.
Furthermore, we measured voxels in two different brain areas containing different kinds of brain matter: one voxel was located in posterior cingulate gray matter (PCGM) and the other in parietal white matter (PWM)."|one time measurement at study baseline|||mM||Standard Deviation|Mean
740774|NCT00472797|Other Pre-specified|SF-36 Physical and Mental Component Scores|Change from Baseline to each visit for Physical and Mental Component scores for SF-36. Score is norm-based with a mean of 50 and a standard deviation of 10.|Change from Baseline to Each Visit|ITT||Score||Standard Deviation|Mean
740775|NCT00472797|Secondary|Tolerability - Redness at Injection Site|Change in Baseline to Week 12 Last Observation Carried Forward(LOCF)- A blinded assessment of injection site redness was conducted by a health care professional (1-72 hours) after the most recent injection measuring redness at its widest diameter in mm. Diameter of Redness, lower is better.|Baseline to Week 12 (LOCF)|ITT and LOCF||mm||Standard Deviation|Mean
740780|NCT00472797|Primary|Percent Change in Global Side Effects (GSE) on Multiple Sclerosis Treatment Concerns Quesionnaire (MSTCQ)|The MSTCQ Global Side Effect domain assesses the degree of satisfaction on global side effect questions 9, 10 & 11 on a scale from 3 (not at all satisfied) to 15 (extremely satisfied). Percent change calculated as 100% * (score at week 12 – score at baseline) / score at baseline.|% change from Baseline to Week 12|Safety: This population includes all subjects who received at least one dose of study drug. To explain difference in number, 1 subject lost to follow-up, 1 subject withdrew consent||percent change||Standard Deviation|Mean
740781|NCT00472849|Primary|Maximum Total Tolerated Dose (MTD) of Daily Combination Fludarabine 30 mg/m^2 and Cytarabine 500 mg/m^2 Among 3 Dose Levels (Dose Level 1: 2 Days, Dose Level 2: 3 Days or Dose Level 3: 4 Days)|Maximum dose levels for Phase I determined among three possible dose levels of Fludarabine and Cytarabine in combination with fixed doses of Oxaliplatin and Rituximab. Fludarabine and Cytarabine Dose Level 1: Days 2-3 (2 Days); Dose Level 2: Days 2-4 (3 Days); and Dose 3: Days 2-5 (4 Days). MTD is dose level at which less than 2/3 or 2/6 participants experience dose limiting toxicities (DLTs). The number of days of fludarabine and cytarabine administration increased simultaneously. Participants received a subsequent cycle of treatment with 1 additional day of fludarabine and cytarabine treatment no less than 4 weeks from the initiation of the previous cycle if no drug-related grade 3 or 4 non-hematologic life-threatening adverse events, and drug-related non-hematologic toxicity resolved to baseline or < grade 2. A maximum of 6 cycles were administered.|Up to 36 weeks (6 cycles each 4-6 weeks)|||mg/m^2|||Number
740782|NCT00472849|Secondary|Overall Response: Number of Participants With Complete Remission, Nodular Partial Remission, and Partial Remission|Overall Response includes Complete remission (CR), nodular partial remission (nPR), and partial remission (PR) in high-risk, previously untreated participants with Chronic Lymphocytic Leukemia treated with CFAR using National Cancer Institute - Working Group response criteria. CR defined as zero nodes, Liver/spleen not palpable, zero symptoms, polymorphonuclear leukocyte (PMN)>1,500/uL, Platelets >100,000uL, Hemoglobin (untransfused) >11.0g/dL, Lymphocytes <4,000/uL and Bone Marrow Aspirate biopsy <30% lymphocytes with no lymphocyte infiltrate; PR defined as nodes >/= 50% decrease,Liver/spleen >/= 50% decrease, symptoms not applicable, PMN >1,500/uL or >50% improvement from baseline, Platelets 100,000uL or >/=50% decrease improvement from baseline, Hemoglobin (untransfused) >11.0g/dL or >50% improvement from baseline, Lymphocytes >50% decrease and Bone Marrow Aspirate biopsy Not Applicable for PR; with nPR defined same as PR but with <30% lymphocytes with residual disease on biopsy.|Up to 36 weeks (6 cycles each 4-6 weeks)|||participants|||Number
740783|NCT00474487|Secondary|Number of Subjects With Local and Systemic Reactions, Ages 56 to 65 Years|Safety profile following a single vaccination of MenACWY vaccine and of a single vaccination of a licensed meninococcal ACWY polysaccharide vaccine administered to healthy subjects (ages 56 to 65 years).|Days 1 to 7|The analysis was done on the safety population.||Subjects|||Number
740784|NCT00474487|Secondary|Number of Subjects With Local and Systemic Reactions, Ages 19 to 55 Years|Safety profile following a single vaccination of MenACWY CRM vaccine and of a single vaccination of a licensed meningococcal ACWY conjugate vaccine administered to healthy subjects (ages 19 to 55 years).|Days 1 to 7|The analysis was performed on the safety population.||Subjects|||Number
740785|NCT00474487|Secondary|Summary of hSBA GMTs (Ages 56 to 65 Years), PP Population|Immunogenicity of a single dose of MenACWY and of a single dose of the licensed meningococcal ACWY conjugate vaccine, as measured by serum bactericidal activity geometric mean titer (GMT) response using human complement (hSBA GMTs) directed against N meningitidis serogroups A, C, W-135, and Y at 1 month after vaccination, when administered to healthy subjects 56 to 65 years of age.|1 month postvaccination|The analysis was performed on the per-protocol (PP) population.||Titers||95% Confidence Interval|Geometric Mean
740786|NCT00474487|Secondary|Summary of hSBA GMTs (Ages 19 to 55 Years), PP Population|Immunogenicity of a single dose of MenACWY and of a single dose of the licensed meningococcal ACWY conjugate vaccine, as measured by serum bactericidal activity geometric mean titer (GMT) response using human complement (hSBA GMTs) directed against N meningitidis serogroups A, C, W-135, and Y at 1 month after vaccination, when administered to healthy subjects 19 to 55 years of age.|1 month postvaccination|The analysis was performed on the per-protocol (PP) population.||Titers||95% Confidence Interval|Geometric Mean
740787|NCT00474487|Secondary|Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 56 to 65 Years), PP Population|"Immunogenicity of the MenACWY vaccine and of a licensed meningococcal ACWY conjugate vaccine, defined as percentage of subjects with seroresponse, human Serum Bactericidal Activity (hSBA) ≥ 1:8 directed against N meningitidis serogroups A, C, W, and Y (healthy subjects aged 56 to 65 years).
Seroresponse: For a subject with hSBA titer <1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline."|1 month postvaccination|The analysis was performed on the per-protocol (PP) population.||Percentage of subjects||95% Confidence Interval|Number
740788|NCT00474487|Secondary|Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 19 to 55 Years), PP Population|"Immunogenicity of the MenACWY vaccine and of a licensed meningococcal ACWY conjugate vaccine, defined as percentage of subjects with seroresponse, human Serum Bactericidal Activity (hSBA) ≥ 1:8 directed against N meningitidis serogroups A, C, W, and Y (healthy subjects aged 19 to 55 years).
Seroresponse: For a subject with hSBA titer <1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline."|1 month postvaccination|The analysis was performed on the per-protocol (PP) population.||Percentage of subjects||95% Confidence Interval|Number
740789|NCT00474487|Primary|Number of Subjects With at Least One Severe Systemic Reaction, Ages 19 to 55 Years|Safety of the Novartis MenACWY conjugate vaccine and of a licensed meningococcal ACWY conjugate vaccine as measured by the number of subjects presenting at least one severe systemic reaction during the first 7 days following a single vaccination in healthy subjects.|Days 1 to 7|The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.||Subjects|||Number
740847|NCT00474630|Secondary|Change in Fasting LDL Cholesterol Levels||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||mg/dL||Standard Error|Least Squares Mean
740833|NCT00474539|Secondary|Percentage of Participants Achieving a Serum Bactericidal Assay (SBA) Titer ≥ 1:8 in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose|Percentage of participants achieving a meningococcal C SBA serum antibody titer ≥ 1:8 along with the corresponding 95% confidence interval (CI) are presented.|One month after toddler dose (at 16 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n)= number of participants with a determinate IgG antibody concentration to the given concomitant vaccine component.||percentage of participants||95% Confidence Interval|Number
740834|NCT00474539|Primary|Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose|GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMCs (13vPnC) were calculated for each pneumococcal serotype and timepoint, and 2-sided, 95% CI were constructed.|One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)|The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.||μg/mL||95% Confidence Interval|Geometric Mean
740835|NCT00474539|Primary|Percentage of Participants Achieving Antibody Level ≥ 0.35μg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose|Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥ 0.35 μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)|The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.||percentage of participants||95% Confidence Interval|Number
740836|NCT00474539|Primary|Geometric Mean Antibody Concentrations (GMC) for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose||One month after infant series dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)|The evaluable 3-dose immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.||IU/mL||95% Confidence Interval|Geometric Mean
740837|NCT00474539|Primary|Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose|Predefined antibody levels for Diphtheria (0.01 or 0.1 International units [IU]/mL) and Tetanus (0.01 or 0.1 [IU]/mL).|One month after infant series dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)|The evaluable 3-dose immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.||percentage of participants||95% Confidence Interval|Number
740838|NCT00474539|Primary|Geometric Mean Titers (GMT) for Meningococcal C Antibodies in as Measured by Serum Bactericidal Assay (SBA) 13vPnC Group Relative to 7vPnC Group After the 2-dose NeisVac-C Infant Series and the Toddler Dose||One month after infant series dose 2 (at 5 months of age) and one month after toddler dose (at 16 months of age)|The evaluable 2-dose immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.||titer||95% Confidence Interval|Geometric Mean
740839|NCT00474539|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events|Systemic events (fever [Fv] ≥ 37.5 degrees Celsius [C], fever ≥ 38 C but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased (Decr) appetite, irritability, increased (Incr) sleep, decreased sleep, hives, use of medication (Meds) to treat symptoms (Sx), and use of medication to prevent symptoms were reported using an electronic diary. Participants may be represented in more than 1 category.|During the 4-day period after each dose|The safety population included all subjects who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.||percentage of participants|||Number
740840|NCT00474539|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Local Reactions|Local reactions were collected using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (Sig)(present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (Mod) (2.5 to 7.0 cm); Severe (Sev) (>7.0 cm). Participants may be represented in more than 1 category.|During the 4-day period after each dose|The safety population included all participants who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.||percentage of participants|||Number
740841|NCT00474539|Primary|Percentage of Participants Achieving a Serum Bactericidal Assay (SBA) Titer ≥ 1:8 in 13vPnC Group Relative to 7vPnC Group After the 2-dose NeisVac-C Infant Series|Percentage of participants achieving a meningococcal C SBA serum antibody titer greater than or equal to (≥) 1:8 along with the corresponding 95% confidence interval (CI) are presented.|One month after infant series dose (at 5 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n)= number of participants with a determinate immunoglobulin G (IgG) antibody concentration to the given concomitant vaccine component.||percentage of participants||95% Confidence Interval|Number
740842|NCT00474630|Secondary|Change in Food Craving Inventory Carbohydrates Subscale Score|The Food Craving Inventory is a 33-item self-report measure designed to assess specific food cravings and is organized into 4 subscales (high fats, sweets, carbohydrates/starches, and fast-food fats). A craving was defined as an intense desire to consume a particular food (or food type) that was difficult to resist over the past month. Subjects rated their frequency of cravings for each of the 33 items using a 5-point scale, where 1=never, 2=rarely, 3=sometimes, 4=often, and 5=always. The carbohydrates subscale consisted of 8 items and the score ranges from 8 (better outcome) to 40 (worse outcome).|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||units on a scale||Standard Error|Least Squares Mean
740843|NCT00474630|Secondary|Change in Food Craving Inventory Sweets Subscale Score|The Food Craving Inventory is a 33-item self-report measure designed to assess specific food cravings and is organized into 4 subscales (high fats, sweets, carbohydrates/starches, and fast-food fats). A craving was defined as an intense desire to consume a particular food (or food type) that was difficult to resist over the past month. Subjects rated their frequency of cravings for each of the 33 items using a 5-point scale, where 1=never, 2=rarely, 3=sometimes, 4=often, and 5=always. The sweets subscale consisted of 8 items and the score ranges from 8 (better outcome) to 40 (worse outcome).|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||units on a scale||Standard Error|Least Squares Mean
740844|NCT00474630|Secondary|Change in IDS-SR Total Scores|IDS-SR= Inventory of Depressive Symptoms-Subject Rated IDS-SR total score is based on 30 items. The total score can range from 0-84, with 0 being no depressive symptoms and 84 being very severe depressive symptoms. A total score ≤ 13 indicates no depression.|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||units on a scale||Standard Error|Least Squares Mean
740845|NCT00474630|Secondary|Change in Diastolic Blood Pressure||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||mm Hg||Standard Error|Least Squares Mean
740846|NCT00474630|Secondary|Change in Systolic Blood Pressure||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||mm Hg||Standard Error|Least Squares Mean
740848|NCT00474630|Secondary|Change in Question 19 From 21-Item COE (Control of Eating) Questionnaire|Question 19: Generally, how difficult has it been to control your eating? Scoring: 0=not at all difficult; 100=extremely difficult|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||units on a scale||Standard Error|Least Squares Mean
740849|NCT00474630|Secondary|Percent of Subjects Discontinuing Due to Poor Glycemic Control|Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed. Odds ratio not calculated as there were no subjects in the NB32 group that discontinued due to poor glycemic control.|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||percentage of participants||95% Confidence Interval|Number
740850|NCT00474630|Secondary|Change in High-sensitivity C Reactive Protein (Hs-CRP) Levels, Using Log-transformed Data||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||percent change||95% Confidence Interval|Least Squares Mean
740851|NCT00474630|Secondary|Change in IWQOL-Lite Total Scores|IWQOL-Lite= Impact of Weight on Quality of Life-Lite Questionnaire Total score is based on a scale from 0 to 100, with 0 representing the poorest and 100 the best quality of life and where a score of 71-79 indicates moderate impairment|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||units on a scale||Standard Error|Least Squares Mean
740852|NCT00474630|Secondary|HbA1c- Proportion of Subjects With HbA1c <6.5% at Endpoint||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||percentage of participants||95% Confidence Interval|Number
740853|NCT00474630|Secondary|Change in Fasting Insulin Levels, Using Log-transformed Data||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||percent change||95% Confidence Interval|Least Squares Mean
740854|NCT00474630|Secondary|Change in HOMA-IR Levels, Using Log-transformed Data|HOMA-IR= Homeostasis Model Assessment-Insulin Resistance|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||percent change||95% Confidence Interval|Least Squares Mean
740855|NCT00474630|Secondary|Percent of Subjects With Dose Increase in Oral Antidiabetes Medications||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||percentage of participants||95% Confidence Interval|Number
740856|NCT00474630|Secondary|Percent of Subjects With Dose Reduction in Oral Antidiabetes Medications||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||percentage of participants||95% Confidence Interval|Number
740857|NCT00474630|Secondary|Percent of Subjects Requiring Rescue Medications for Diabetes||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||percentage of participants||95% Confidence Interval|Number
740858|NCT00474630|Secondary|HbA1c- Proportion of Subjects With HbA1c <7% at Endpoint||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||percentage of participants||95% Confidence Interval|Number
740859|NCT00474630|Secondary|Body Weight- Proportion of Subjects With ≥10% Decrease||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||percentage of participants||95% Confidence Interval|Number
740860|NCT00474630|Secondary|Change in Waist Circumference||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||cm||Standard Error|Least Squares Mean
740861|NCT00474630|Secondary|Change in Fasting Blood Glucose Levels||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||mg/dL||Standard Error|Least Squares Mean
740862|NCT00474630|Secondary|Change in Fasting HDL Cholesterol Levels||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||mg/dL||Standard Error|Least Squares Mean
740863|NCT00474630|Secondary|Change in Fasting Triglycerides Levels, Using Log-transformed Data||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||percent change||95% Confidence Interval|Least Squares Mean
740864|NCT00474630|Primary|Co-primary: Body Weight- Proportion of Subjects With ≥5% Decrease||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||percentage of participants||95% Confidence Interval|Number
740865|NCT00474630|Secondary|Change in HbA1c Levels||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||percent||Standard Error|Least Squares Mean
740866|NCT00474630|Primary|Co-primary: Body Weight- Mean Percent Change||Baseline, 56 weeks|Modified ITT (Full Analysis Set): Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||percentage of body weight||Standard Error|Least Squares Mean
740867|NCT00474708|Secondary|Number of Patients Achieving Remission (by Co-morbid Anxiety Disorder Status)|Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most sever) for a maximum total score of 50.|12 weeks|The analysis population is the per protocol population, consisting of patients who have received at least one dose and have completed the 12 week clinical assessment. A total of 125 (VEN XR=83, SSRI=42) patients had a co-morbid anxiety disorder and 834 (VEN XR=581, SSRI=253) did not.||participants|||Number
740868|NCT00474708|Primary|Number of Patients Achieving Remission|Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most sever) for a maximum total score of 50.|12 weeks|The analysis population is the per protocol population, consisting of patients who have received at least one dose and have completed the 12 week clinical assessment.||participants|||Number
740869|NCT00474760|Secondary|Number of Insulin-like Growth Factor 1 Receptor (IGF-1R) Positive CTCs|Quantification of IGF-IR positive CTCs using an automated microscope system|30 minutes predose in all cycles (up to 17); 1, 3, 7, and 14 days postdose in Cycle 1 for dose escalation and RP2D extension cohorts; and also 1 day postdose in Cycle 4 for RP2D extension cohort|Pretreatment IGF-1R positive CTCs were detected in an insufficient number of participants to analyze for any treatment effect on this pharmacodynamic biomarker.|||||
740870|NCT00474760|Secondary|Number of Circulating Tumor Cells (CTCs)|Quantification of CTCs using an automated microscope system|30 minutes predose in all cycles (up to 17); 1, 3, 7, and 14 days postdose in Cycle 1 for dose escalation and RP2D extension cohorts; and also 1 day postdose in Cycle 4 for RP2D extension cohort|Pretreatment CTCs were detected in an insufficient number of participants to analyze for any treatment effect on this pharmacodynamic biomarker.|||||
740871|NCT00474760|Secondary|Human Anti-human Antibodies (HAHA) Levels|HAHA were indicators of immunogenicity to figitumumab.|30 minutes predose in Cycles 1 up to 61, and last scheduled follow-up visit (up to 150 days from the last dose of study drug)|Per protocol, the presence of HAHA would only be evaluated for those samples with plasma figitumumab concentrations below the limit of quantification (BLQ). Since none of the postdose samples in the study had figitumumab concentrations BLQ, therefore no sample was analyzed for HAHA.|||||
740872|NCT00474760|Secondary|Area Under the Plasma Concentration-time Profile From Time 0 to 672 Hours (28 Days) (AUC672) in Cycle 4||Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest in RP2D ESFT extension cohort. N=number of participants evaluable for the outcome measure||mg*hr/L||Standard Deviation|Mean
740873|NCT00474760|Secondary|Area Under the Plasma Concentration-time Profile From Time 0 to 672 Hours (28 Days) (AUC672) in Cycle 1||Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest in RP2D ESFT extension cohort. N=number of participants evaluable for the outcome measure||mg*hr/L||Standard Deviation|Mean
740874|NCT00474760|Secondary|Area Under the Plasma Concentration-time Profile From Time 0 to 504 Hours (21 Days) (AUC504) in Cycle 4||Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest in all cohorts except ESFT extension cohort. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: 20 mg/kg RP2D every 3 weeks.||mg*hr/L||Standard Deviation|Mean
740875|NCT00474760|Secondary|Area Under the Plasma Concentration-time Profile From Time 0 to 504 Hours (21 Days) (AUC504) in Cycle 1||Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest in all cohorts except ESFT extension cohort. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: 20 mg/kg RP2D every 3 weeks.||mg*hr/L||Standard Deviation|Mean
740876|NCT00474760|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] in Cycle 1|Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0 - ∞).|Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.||mg*hr/L||Standard Deviation|Mean
740877|NCT00474760|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) in Cycle 4|Area under the plasma concentration time-curve from zero to the last measured concentration|Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest in extension cohorts. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.||mg*hr/L||Standard Deviation|Mean
740878|NCT00474760|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) in Cycle 1|Area under the plasma concentration time-curve from zero to the last measured concentration|Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.||milligram*hour/liter (mg*hr/L)||Standard Deviation|Mean
740879|NCT00474760|Secondary|Volume of Distribution at Steady State (Vss) in Cycle 4|Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vss is the Vz at steady-state.|Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest in extension cohorts. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.||mL/kg||Standard Deviation|Mean
740880|NCT00474760|Secondary|Volume of Distribution at Steady State (Vss) in Cycle 1|Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vss is the Vz at steady-state.|Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.||mL/kg||Standard Deviation|Mean
740881|NCT00474760|Secondary|Volume of Distribution (Vz) in Cycle 4|Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.|Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest in extension cohorts. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.||mL/kg||Standard Deviation|Mean
740882|NCT00474760|Secondary|Volume of Distribution (Vz) in Cycle 1|Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.|Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.||milliliter/kilogram (mL/kg)||Standard Deviation|Mean
740883|NCT00474760|Secondary|Concentration at End of Infusion (Cendinf) in Cycle 4||Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest in extension cohorts. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.||mg/L||Standard Deviation|Mean
740884|NCT00474760|Secondary|Concentration at End of Infusion (Cendinf) in Cycle 1||Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.||mg/L||Standard Deviation|Mean
740885|NCT00474760|Secondary|Systemic Clearance (CL) in Cycle 4|CL is a quantitative measure of the rate at which a drug substance is removed from the body.|Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest in extension cohorts. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.||mL/day/kg||Standard Deviation|Mean
740886|NCT00474760|Secondary|Systemic Clearance (CL) in Cycle 1|CL is a quantitative measure of the rate at which a drug substance is removed from the body.|Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.||milliliter/day/kilogram (mL/day/kg)||Standard Deviation|Mean
740887|NCT00474760|Secondary|Time to Reach Last Quantifiable Concentration (Tlast) in Cycle 4||Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest in extension cohorts. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.||hours||Standard Deviation|Mean
740888|NCT00474760|Secondary|Time to Reach Last Quantifiable Concentration (Tlast) in Cycle 1||Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.||hours||Standard Deviation|Mean
740889|NCT00474760|Secondary|Plasma Decay Half-Life (t1/2) in Cycle 4|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest in extension cohorts. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.||hours||Standard Deviation|Mean
740890|NCT00474760|Secondary|Plasma Decay Half-Life (t1/2) in Cycle 1|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.||hours||Standard Deviation|Mean
740891|NCT00474760|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) in Cycle 4||Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest in extension cohorts. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.||hours||Standard Deviation|Mean
740892|NCT00474760|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) in Cycle 1||Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.||hours||Standard Deviation|Mean
740893|NCT00474760|Secondary|Maximum Observed Plasma Concentration (Cmax) in Cycle 4||Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest in extension cohorts. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.||mg/L||Standard Deviation|Mean
740894|NCT00474760|Secondary|Maximum Observed Plasma Concentration (Cmax) in Cycle 1||Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the pharmacokinetic (PK) parameters of primary interest. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.||milligram/liter (mg/L)||Standard Deviation|Mean
740895|NCT00474760|Primary|Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 150 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to 150 days after the last administration of study drug|All enrolled participants who started treatment.||participants|||Number
740896|NCT00474786|Other Pre-specified|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to [study drug] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.|Baseline up to 24 months|Safety population: all participants who received at least 1 dose of test article.||participants|||Number
740897|NCT00474786|Secondary|Duration of Response (DR)|Duration of response as defined by the time from CR or PR (whichever status recorded first) until the date of death or PD was objectively documented. Median and its 95 percent confidence interval (95% CI) were estimated using Kaplan-Meier method.|Baseline up to 24 Months|ITT population||months||95% Confidence Interval|Median
740898|NCT00474786|Secondary|Percentage of Participants With PFS Events at 12, 24 and 36 Weeks by Independent Assessment|PFS: Interval from date of randomization until documentation of PD by an independent tumor assessment according to RECIST or death for any reason whichever occurred first. PFS calculated as (Weeks)=(randomization date minus first dose date plus 1) divided by 7.|Weeks 12, 24, and 36|ITT population||percentage of participants|||Number
740899|NCT00474786|Secondary|Overall Survival (OS)|Overall survival was the duration from randomization to death. For participants who are alive, overall survival was censored at the last contact.|Baseline to date of death from any cause (up to 24 months)|ITT population||months||95% Confidence Interval|Median
740900|NCT00474786|Secondary|Percentage of Participants With Tumor Response|Percentage of participants with tumor response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST and evaluated by independent central review. CR/PR persisted on repeat imaging study at least 4 weeks after initial documentation of response. PR had at least 30 percent decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.|Baseline up to 24 Months|ITT population||percentage of participants||95% Confidence Interval|Number
740901|NCT00474786|Secondary|Progression Free Survival (PFS) by Investigator Assessment|Interval from date of randomization until documentation of PD by an investigator tumor assessment, symptomatic deterioration, or death for any reason whichever occurred first.|Baseline up to 24 Months|ITT population||months||95% Confidence Interval|Median
740902|NCT00474786|Primary|Progression-Free Survival (PFS)|Interval from date of randomization until documentation of progressive disease (PD) by an independent tumor assessment according to Response Evaluation Criteria in Solid Tumor (RECIST) or death for any reason whichever occurred first.|Baseline up to 24 Months|Intent to Treat Population (ITT): all randomized participants according to their assigned treatment, regardless of whether they were received any study drug.||months||95% Confidence Interval|Median
740903|NCT00474812|Secondary|Gait Speed|Gait speed, determined by a 4 meter walk along a properly measured stretch of hallway while being timed with a stopwatch.|at 8 weeks|Participants who were ambulatory at 8 weeks||meters per second||Standard Error|Mean
740904|NCT00474812|Secondary|Gait Speed|Gait speed, determined by a 4 meter walk along a properly measured stretch of hallway while being timed with a stopwatch.|baseline|Participants who were ambulatory at baseline||meters per second||Standard Error|Mean
740905|NCT00474812|Secondary|Median Progression Free Survival (PFS)|Number of months patients were free of disease progression, defined as < 20% increase in the sum of the LD of target lesions nor the appearance of one or more new lesions.|Up to 5 years|Intent to treat||months||95% Confidence Interval|Median
740950|NCT00475150|Secondary|The Number of Patients That Report Adverse Events Possibly, Probably, or Definitely Related to AZD2171.|Graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. All adverse events determined to be possibly, probably, or definately related to AZD2171 are included in this analysis.|Continuously during treatment up to 26 courses|All participants were analyzed for this endpoint.||participants|||Number
740906|NCT00474812|Secondary|Objective Response Rate (Complete Response, Partial Response, or Stable Disease), Evaluated Using the New International Criteria Proposed by the RECIST Committee|Response is defined as CR (Complete Response), PR (Partial Response) or SD (Stable Disease) per Response Evaluation Criteria in Solid Tumor (RECIST criteria). Possible evaluations include: CR: Disappearance of all target lesions. PR: At least a 30% decrease in the size of target lesions. SD: neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as progressive disease (PD). Progressive disease (PD) is defined as: at least a 20% increase in the sum of the LD of target lesions.|Up to 5 years|Patients that reached first scans at 2 months||participants|||Number
740907|NCT00474812|Primary|Median Overall Survival|From the date of onset of treatment to the date of death and to the date of last follow-up for those still alive, assessed up to 24 months|assessed up to 24 months|Intent to treat.||months||95% Confidence Interval|Median
740908|NCT00474851|Secondary|Total Body Bone Mineral Content (BMC)||Baseline to 12 months|||g||Standard Error|Mean
740909|NCT00474851|Primary|Bone Mineral Density|Adjusted mean change in total body areal bone mineral density (aBMD) over the 12 month trial|Baseline to 12 months|||g/cm^2||Standard Error|Mean
740910|NCT00474903|Secondary|Toxicity|Toxicity is defined as adverse events that are classified as either possibly, probably, or definitely related to the interventional agent, graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The number of patients reporting adverse events will be tabulated by grade.|Up to 30 days after completion of study treatment|All 120 patients that took study medication were evaluable for this secondary endpoint.||participants|||Number
740911|NCT00474903|Primary|Change in Mean Tissue Prostaglandin E2 (PGE2) Concentration as Determined From Barrett's Research Mucosal Biopsy Samples|The mean tissue PGE2 is reported for each Arm.|Baseline to 30 days after completion of study treatment|||pg/mL||Standard Deviation|Mean
740912|NCT00474929|Secondary|Progression Free Survival|Progression Free Survival is defined as the time from registration to the earliest date documentation of disease progression or death. The distribution of time to disease progression will be estimated using the method of Kaplan-Meier.|Up to 3 years from registration|||months||95% Confidence Interval|Median
740913|NCT00474929|Secondary|Survival Time|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.|Up to 3 years from registration|||months||95% Confidence Interval|Median
740914|NCT00474929|Primary|Proportion of Confirmed Tumor Responses|"A confirmed response is defined to be a CR or PR noted as the objective status for eligible patients during cycles 1-12.
Complete Response (CR):
Multiple Myeloma (MM): Negative immunofixation of serum and urine, disappearance of soft tissue plasmacytomas, and normalization of free light chain (FLC) ratio.
Lymphoma: Disappearance of all clinical and radiographic evidence of disease, all lymph nodes of normal size (1.5 cm or less), no splenomegaly.
Partial Response (PR):
MM: 50% reduction of serum or urine M-protein or to less than 200mg/day, a 50% reduction in the difference between involved and uninvolved FLC, and 50% reduction in the size of soft tissue plasmacytoma.
Lymphoma: 50% or greater reduction in sum of the products of the dimension for nodal masses; no increase in liver, spleen or node size; no new sites of disease; and a 50% decrease in lymphocyte count if followed at baseline."|Up to 12 cycles of treatment|||percentage of participants|||Number
740915|NCT00474929|Primary|Number of Participants Reporting a Dose Limiting Toxicity (DLT)|"The Maximum Tolerated Dose (MTD) is defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients (at least 2 of a maximum of 6 new patients). Dose-limiting toxicity (DLT) is defined as an adverse event attributed (definitely, probably, or possibly) in first cycle to the study treatment and meeting the following criteria:
Grade 4 infection
Grade 4 ANC or PLT
Grade 3 or higher non-hematologic adverse event.
NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0 will be used to assess adverse events. For this endpoint, the number of patients reporting a DLT event are tabulated."|First cycle (28 days) of study treatment|||participants|||Number
740916|NCT00474955|Secondary|Mean Change From Baseline in Heart Rate up to Week 72|Mean change from baseline in heart rate was recorded at Baseline (Screening visit [Days -30 to -1]), and at various Visits (V): Week 2 (V2), Week 4 (V3), Week 12 (V4), Week 24 (V5), Week 36 (V6) and Week 48 (V7), and after treatment completion at follow-up (FU) Week 4 (Week 52, V8), FU Week 12 (Week 60, V9), and FU Week 24 (Week 72, V10).|From Baseline (Days -30 to -1) to Week 72|ITT population included all enrolled participants who received at least one dose of study medication. Number of participants evaluable at a particular visit was determined by ‘n’.||Beats per minute (bpm)||Standard Deviation|Mean
740917|NCT00474955|Secondary|Mean Change From Baseline in Blood Pressure up to Week 72|Mean change from Baseline in diastolic blood pressure (DBP) and systolic blood pressure (SBP) was recorded at Baseline (Screening visit [Days -30 to -1]) and at various Visits (V): Week 2 (V2), Week 4 (V3), Week 12 (V4), Week 24 (V5), Week 36 (V6) and Week 48 (V7) and after treatment completion at follow-up (FU) Week 4 (Week 52, V8), FU Week 12 (Week 60, V9), and FU Week 24 (Week 72, V10).|From Baseline (Days -30 to -1) to Week 72|ITT population included all enrolled participants who received at least one dose of study medication. Number of participants evaluable at a particular visit was determined by ‘n’.||Millimeter (mm) of Mercury||Standard Deviation|Mean
740918|NCT00474955|Secondary|Number of Participants With Any Marked Abnormality in Laboratory Parameters Over a Period of 72 Weeks|Marked abnormal laboratory parameters included serum glutamic pyruvic transaminase (SGPT), serum glutamic oxaloacetic transaminase (SGOT), gamma-glutamyl transpeptidase (GGTP), total bilirubin, alkaline phosphatase (ALP), ferritin and transferrin saturation. These laboratory parameters were evaluated at Baseline (Screening visit [Days -30 to -1]) and at various Visits (V): Week 0 (V1), Week 2 (V2), Week 4 (V3), Week 12 (V4), Week 24 (V5), Week 36 (V6) and Week 48 (V7) and after treatment completion at follow-up (FU) Week 4 (Week 52, V8), FU Week 12 (Week 60, V9), and FU Week 24 (Week 72, V10).|Up to Week 72|ITT population included all enrolled participants who received at least one dose of study medication.||Participants|||Number
740919|NCT00474955|Secondary|Number of Participants Who Prematurely Withdrew From the Treatment Over a Period of 48 Weeks|Participants who prematurely withdrew from the treatment for the following reasons: personal reasons (not related to the study), adverse events, and drug unavailability, are presented.|Up to Week 48|ITT population included all enrolled participants who received at least one dose of study medication.||Participants|||Number
740920|NCT00474955|Secondary|Number of Participants Who Experienced Any Adverse Events or Serious Adverse Events|An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect|Up to Week 72|Safety population included all enrolled participants who received at least one dose of study medication, whether withdrawn prematurely or not, and who had at least one follow-up data point were included.||Participants|||Number
740921|NCT00474955|Primary|Percentage of Participants With At Least a 2log10 Drop in Hepatitis C Virus Ribonucleic Acid at Week 24 as Compared to Baseline|The table below shows the percentage of participants with at least 2log10 drop in HCV RNA level at Week 24 as compared to Baseline (Screening visit [Days -30 to -1]).|From Baseline (Days -30 to -1) and Week 24|ITT population included all enrolled participants who received at least one dose of study medication.||Percentage of participants|||Number
740922|NCT00474955|Primary|Percentage of Participants With Undetectable Hepatitis C Virus Ribonucleic Acid Level at Week 24 and Week 48|HCV RNA level less than 50 IU/mL was considered to be undetectable.|At Week 24 and Week 48|ITT population included all enrolled participants who received at least one dose of study medication.||Percentage of participants|||Number
740923|NCT00474955|Primary|Percentage of Participants Achieving Sustained Virologic Response at 24 Weeks Following Treatment Completion|Sustained virologic response is defined as undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) levels (<50 international units [IU]/mL) at 24 weeks following the completion of 48 weeks treatment period (Week 72).|At Week 72|ITT population included all enrolled participants who received at least one dose of study medication.||Percentage of participants|||Number
740924|NCT00474968|Primary|Specimen Adequacy|Number and percentage of samples classified as adequate for diagnosis|At time of cell collection|Includes all cytology specimens||Participants|||Number
740925|NCT00474968|Secondary|Human Papilloma Virus (HPV) Detection Frequency|Number and percentage of HPV positive specimens by the Hybrid Capture II (HC-II) assay|At the time of cell collection.|||Participants|||Number
740926|NCT00474968|Primary|Cell Collection Efficacy|True Positive (TP); True Negative (TN), False Positive (FP) and False Negative (FN) participants and percentage of participants based upon comparison of the cytology diagnosis (Dx) with biopsy (Bx) and endocervical curretage (ECC) results from the same patient.|At the time of cell collection.|79/348 (Arm 1) and 81/355 (Arm 2) participants were excluded from the sensitivity/specificity analysis due to biopsy (Bx) and/or endocervical curettage (ECC) results not being reported||Participants|||Number
740927|NCT00474994|Primary|Overall Objective Response|as assessed by RECIST criteria|2 years|||participants|||Number
740928|NCT00475033|Other Pre-specified|Percentage of Subjects Reporting Pre-specified Systemic Events in the 13vPnC and 7vPnC Group: Toddler Dose (12 Months of Age)|Systemic events (any fever ≥38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep were reported using an electronic diary. Subjects may be represented in more than 1 category.|Within 4 days after dose (12 months of age)|Safety population; N=number of subjects reporting any systemic events; (n)=number of subjects reporting yes for at least 1 day or no for all days for the 13vPnC and 7vPnC groups, respectively.||percentage of subjects|||Number
740929|NCT00475033|Other Pre-specified|Percentage of Subjects Reporting Pre-specified Systemic Events in the 13vPnC and 7vPnC Group: Infant Series Dose 3 (6 Months of Age)|Systemic events (any fever ≥38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep were reported using an electronic diary. Subjects may be represented in more than 1 category.|Within 4 days after dose (6 months of age)|Safety population; N=number of subjects reporting any systemic events; (n)=number of subjects reporting yes for at least 1 day or no for all days for the 13vPnC and 7vPnC groups, respectively.||percentage of subjects|||Number
740930|NCT00475033|Other Pre-specified|Percentage of Subjects Reporting Pre-specified Systemic Events in the 13vPnC and 7vPnC Group: Infant Series Dose 2 (4 Months of Age)|Systemic events (any fever ≥38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep were reported using an electronic diary. Subjects may be represented in more than 1 category.|Within 4 days after dose (4 months of age)|Safety population; N=number of subjects reporting any systemic events; (n)=number of subjects reporting yes for at least 1 day or no for all days for the 13vPnC and 7vPnC groups, respectively.||percentage of subjects|||Number
740931|NCT00475033|Other Pre-specified|Percentage of Subjects Reporting Pre-specified Systemic Events in the 13vPnC and 7vPnC Group: Infant Series Dose 1 (2 Months of Age)|Systemic events (any fever ≥38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep were reported using an electronic diary. Subjects may be represented in more than 1 category.|Within 4 days after dose (2 months of age)|Safety population; N=number of subjects reporting any systemic events; (n)=number of subjects reporting yes for at least 1 day or no for all days for the 13vPnC and 7vPnC groups, respectively.||percentage of subjects|||Number
740932|NCT00475033|Other Pre-specified|Percentage of Subjects Reporting Pre-specified Local Reactions in the 13vPnC and 7vPnC Groups: Toddler Dose (12 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Subjects may be represented in more than 1 category.|Within 4 days after dose (12 months of age)|Safety population; N=number of subjects reporting any local reactions; (n)=number of subjects reporting yes for at least 1 day or no for all days for the 13vPnC and 7vPnC groups, respectively.||percentage of subjects|||Number
740951|NCT00475150|Secondary|Duration of Response|Measured from the time criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. Estimated using the method of Kaplan-Meier.|Every 3 courses up to 26 courses|This endpoint was not analyzed due to lack of response.|||||
740933|NCT00475033|Other Pre-specified|Percentage of Subjects Reporting Pre-specified Local Reactions in the 13vPnC and 7vPnC Groups: Infant Series Dose 3 (6 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Subjects may be represented in more than 1 category.|Within 4 days after dose (6 months of age)|Safety population; N=number of subjects reporting any local reactions; (n)=number of subjects reporting yes for at least 1 day or no for all days for the 13vPnC and 7vPnC groups, respectively.||percentage of subjects|||Number
740934|NCT00475033|Other Pre-specified|Percentage of Subjects Reporting Pre-specified Local Reactions in the 13vPnC and 7vPnC Groups: Infant Series Dose 2 (4 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Subjects may be represented in more than 1 category.|Within 4 days after dose (4 months of age)|Safety population; N=number of subjects reporting any local reactions; (n)=number of subjects reporting yes for at least 1 day or no for all days for the 13vPnC and 7vPnC groups, respectively.||percentage of subjects|||Number
740935|NCT00475033|Other Pre-specified|Percentage of Subjects Reporting Pre-specified Local Reactions in the 13vPnC and 7vPnC Groups: Infant Series Dose 1 (2 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Subjects may be represented in more than 1 category.|Within 4 days after dose (2 months of age)|Safety population: all subjects who received at least 1 dose of study vaccine. N=number of subjects reporting any local reactions; (n)=number of subjects reporting yes for at least 1 day or no for all days for the 13vPnC and 7vPnC groups, respectively.||percentage of subjects|||Number
740936|NCT00475033|Secondary|Percentage of Subjects Achieving Predefined Antibody Level ≥1.0 μg/mL for PRP in Hib in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series|Percentage of subjects achieving predefined antibody threshold ≥1.0 μg/mL along with the corresponding 95% CI for concomitant antigen PRP in Hib are presented. Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups > -10%.|1 month after the 3-dose infant series (7 months of age)|The evaluable immunogenicity population was the primary analysis population. N=number of participants analyzed with a determinate post-infant series antibody concentration (titer) to the given antigen.||percentage of subjects||95% Confidence Interval|Number
740937|NCT00475033|Primary|Geometric Mean Concentration (GMC) of PRP in Hib in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series|Antibody geometric mean concentration of PRP in Hib as measured by µg/mL are presented. GMC and corresponding 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution. In addition, the 2-sided 95% confidence interval on the ratio of the GMCs for 13vPnC relative to 7vPnC was constructed by back transformation of the Student t distribution for the mean difference of the measures on the logarithmic scale.|1 month after the 3-dose infant series (7 months of age)|The evaluable immunogenicity population was the primary analysis population; N=number of participants analyzed with a determinate antibody concentration (titer) to the given antigen. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.||GMC µg/mL||95% Confidence Interval|Geometric Mean
740938|NCT00475033|Primary|Percentage of Subjects Achieving Predefined Antibody Level ≥0.15 Micrograms Per mL (μg/mL) for Polyribosylribitol Phosphate (PRP) in Hib in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series|Percentage of subjects achieving predefined antibody threshold ≥0.15 μg/mL along with the corresponding 95 percent (%) confidence interval (CI) for concomitant antigen PRP in Hib are presented. Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups > -10%.|1 month after the 3-dose infant series (7 months of age)|The evaluable immunogenicity population was the primary analysis population. N=number of participants analyzed with a determinate post-infant series antibody concentration to the given antigen.||percentage of subjects||95% Confidence Interval|Number
740939|NCT00475033|Primary|Geometric Mean Concentration (GMC) of Pertussis Antigens in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series|Antibody geometric mean concentration of pertussis antigens (PT, FHA, PRN, and FIM) as measured by EU/mL are presented. GMC and corresponding 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution. In addition, the 2-sided 95% confidence intervals on the ratio of the GMCs for 13vPnC relative to 7vPnC were constructed by back transformation of the Student t distribution for the mean difference of the measures on the logarithmic scale.|1 month after the 3-dose Infant Series (7 months of age)|The evaluable immunogenicity population was the primary analysis population; (n)=number of participants with a determinate antibody concentration (titer) to the given antigen. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.||GMC EU/mL||95% Confidence Interval|Geometric Mean
740940|NCT00475033|Other Pre-specified|Geometric Mean Concentration (GMC) for Pneumococcal IgG Antibody in 13vPnC Group After the Toddler Dose|Antibody geometric mean concentration (GMC) as measured by μg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|1 month after the toddler dose (13 months of age)|The evaluable immunogenicity population was the primary analysis population; (n)=number of participants with a determinate antibody concentration for the given serotype for 13vPnC.||GMC μg/mL||95% Confidence Interval|Geometric Mean
740965|NCT00475306|Primary|Nausea Scale|Patients were asked to report their level of nausea on a scale for 0 to 10, with 0 representing no nausea and 10 the worst nausea imaginable|60 minutes|Only patients who received the investigational medication are included in this analysis. Please see the participant flow section for more details.||units on a scale||Inter-Quartile Range|Median
740941|NCT00475033|Other Pre-specified|Percentage of Subjects Achieving Pneumococcal Immunoglobulin G (IgG) Antibody Level ≥0.35 μg/mL in the 13vPnC Group After the Toddler Dose|Percentage of subjects achieving WHO predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|1 month after the toddler dose (13 months of age)|The evaluable immunogenicity population was the primary analysis population; (n)=number of participants with a determinate IgG antibody concentration to the given serotype for 13vPnC.||percentage of subjects||95% Confidence Interval|Number
740942|NCT00475033|Other Pre-specified|Geometric Mean Concentration (GMC) for Pneumococcal IgG Antibody in 13vPnC Group After the 3-dose Infant Series|Antibody geometric mean concentration (GMC) as measured by μg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|1 month after the 3-dose infant series (7 months of age)|The evaluable immunogenicity population was the primary analysis population; (n)=number of participants with a determinate antibody concentration for the given serotype for 13vPnC.||GMC μg/mL||95% Confidence Interval|Geometric Mean
740943|NCT00475033|Other Pre-specified|Percentage of Subjects Achieving Pneumococcal Immunoglobulin G (IgG) Antibody Level ≥0.35 μg/mL in the 13vPnC Group After the 3-dose Infant Series|Percentage of subjects achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|1 month after the 3-dose infant series (7 months of age)|The evaluable immunogenicity population was the primary analysis population; (n)=number of participants with a determinate IgG antibody concentration to the given serotype for 13vPnC.||percentage of subjects||95% Confidence Interval|Number
740944|NCT00475033|Secondary|Geometric Mean Titer (GMT) of Meningococcal C Antigen in the 13vPnC Group Relative to 7vPnC Group After the Toddler Dose|Antibody geometric mean titer of meningococcal C antigen are presented. GMT and corresponding 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution. In addition, the 2-sided 95% confidence interval on the ratio of the GMs for 13vPnC relative to 7vPnC was constructed by back transformation of the Student t distribution for the mean difference of the measures on the logarithmic scale.|1 month after the toddler dose (13 months of age)|The evaluable immunogenicity population was the primary analysis population; N=number of participants analyzed with a determinate antibody titer to the given antigen. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.||GMT||95% Confidence Interval|Geometric Mean
740945|NCT00475033|Secondary|Percentage of Subjects Achieving Predefined Antibody Level ≥1:8 for Meningococcal C SBA in the 13vPnC Group Relative to 7vPnC Group After the Toddler Dose of NeisVac-C®|Percentage of subjects achieving predefined antibody threshold ≥1:8 along with the corresponding 95% CI for concomitant antigen meningococcal C SBA are presented. Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups > -10%.|1 month after the toddler dose of NeisVac-C® (13 months of age)|The evaluable immunogenicity population was the primary analysis population. N=number of participants analyzed with a determinate post-toddler dose antibody concentration (titer) to the given antigen.||percentage of subjects||95% Confidence Interval|Number
740946|NCT00475033|Primary|Percentage of Subjects Achieving Predefined Antibody Level to Pertussis Antigens in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series|Percentage of subjects achieving predefined antibody threshold ≥5 enzyme-linked immunosorbent assay (ELISA) units per mL (EU/mL) along with the corresponding 95 % CI for concomitant antigens pertussis (pertussis toxoid [PT], filamentous hemagglutinin [FHA], and pertactin [PRN]) and ≥ 2.2 EU/mL fimbrial agglutinogens (FIM) are presented. Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups > -10%.|1 month after the 3-dose infant series (7 months of age)|The evaluable immunogenicity population was the primary analysis population; (n)=number of participants with an antibody concentration (titer) ≥ to prespecified level for the given antigen for 13vPnC and 7vPnC, respectively.||percentage of subjects||95% Confidence Interval|Number
740947|NCT00475033|Primary|Geometric Mean Titer (GMT) of Meningococcal C Antigen in the 13vPnC Group Relative to 7vPnC Group After 2 Doses of NeisVac-C® in the Infant Series|Antibody geometric mean titer of meningococcal C antigen are presented. GMT and corresponding 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution. In addition, the 2-sided 95% confidence interval on the ratio of the geometric means for 13vPnC relative to 7vPnC was constructed by back transformation of the Student t distribution for the mean difference of the measures on the logarithmic scale.|1 month after 2 doses of NeisVac-C® in the infant series (7 months of age)|The evaluable immunogenicity population was the primary analysis population; N=number of participants analyzed with a determinate antibody titer to the given antigen. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.||GMT||95% Confidence Interval|Geometric Mean
740948|NCT00475033|Primary|Percentage of Subjects Achieving Predefined Antibody Level ≥1:8 for Meningococcal C Serum Bactericidal Assay (SBA) in the 13vPnC Group Relative to 7vPnC Group After 2 Doses of NeisVac-C® in the Infant Series|Percentage of subjects achieving predefined antibody threshold ≥1:8 along with the corresponding 95 percent (%) confidence interval (CI) for concomitant antigen meningococcal C SBA are presented. Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups > -10%.|1 month after 2 doses of NeisVac-C® in the infant series (7 months of age)|Evaluable immunogenicity population: had treatments as randomized at all expected doses, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations. N=number of participants analyzed with a determinate post-infant series antibody concentration to the given antigen.||percentage of subjects||95% Confidence Interval|Number
740949|NCT00475085|Primary|Home Record: Severity of Delayed Nausea|1=not at all nauseated to 7=extremely nauseated, therefore higher values are worse|average of day 1 afternoon, evening and night, and all of days 2 and 3|||units on a scale||Standard Deviation|Mean
740952|NCT00475150|Secondary|Progression-free Survival|"Defined as the time from date of registration to date that disease progression was documented, death, or last date that progression-free status was documented, whichever comes first. Estimated using the method of Kaplan-Meier.
Disease progression is defined as one of the following:
A ≥ 50% increase in bone marrow blasts from the best response, or
A 50% or greater decrement from maximum remission/response levels in neutrophils or platelets, or
A reduction in hemoglobin concentration by at least 1.5 g/dl, or
Transfusion dependence (without alternative explanation and sustained for at least 2 weeks)."|Every 3 courses during treatment and then at 3 months and every 6 months for up to 2 years after completion of study treatment|All participants are evaluable for this primary endpoint.||months||95% Confidence Interval|Median
740953|NCT00475150|Secondary|Overall Survival|Defined as the time from date of registration to date of death due to any cause or date last known alive. The distribution of survival time will be estimated using the method of Kaplan-Meier.|Every cycle during treatment and every 6 months for up to 2 years after completion of study treatment|All participants were evaluable for this endpoint.||months||95% Confidence Interval|Median
740954|NCT00475150|Primary|The Number of Confirmed Disease Response: Complete Response (CR), Partial Response (PR), and Hematologic Improvement (HI). A Confirmed Response is Defined to be an Objective Status of CR, PR, or HI Noted on 2 Consecutive Evaluations.|"Complete Response (CR) requires a repeat bone marrow with < 5% myeloblasts, hemoglobin ≥ 11 g/dl, neutrophils ≥ 1000/mm3, platelets ≥ 100,000/mm3, and no circulating blasts.
Partial Response (PR) requires a bone marrow blast reduction of 50% or more, hemoglobin ≥ 11 g/dl, neutrophils ≥ 1000/mm3, platelets ≥ 100,000/mm3, and no circulating blasts.
Hematologic Improvement (HI) requires one of the following:
RBC transfusion independent participants are required to have >1.5 g/dL increase in hemoglobin,
RBC transfusion-dependent participants are required to be transfusion independent,
A 100% increase, and an absolute increase over 500mm^3 in Absolute Neutrophil Count,
Participants with a pretreatment platelet count over 20,000/mm3 require an absolute increase of 30,000/mm^3 or more,
Participants with platelet count below 20,000/mm3 require an increase over 20,000/mm^3 and by at least 100%."|At the end of cycles 1 and 3 and every 3 cycles thereafter up to 26 cycles|All participants were evaluable for this endpoint.||participants|||Number
740955|NCT00475176|Secondary|2-log Decline in HCV RNA by Week 12 (Early Virological Response) and Sustained Eradication of HCV RNA (Sustained Virological Response).|2-log decline in HCV RNA by week 12 (early virological response) and sustained eradication of HCV RNA (sustained virological response).|12 weeks from start of therapy|Of 24 patients enrolled, 3 patients completed first course only due to adverse effects or personal reason. A fourth patient completed both courses but missed blood draws in both courses, precluding calculation of accurate first- and second-phase kinetic parameters. These 4 patient were excluded from analysis.||participants|||Number
740956|NCT00475176|Primary|Improvement in Viral Kinetics During the First 2 Weeks of Therapy|Improvement of slopes of decline in hepatitis C virus Ribonucleic acid in second course compared with first course in days 7 to 14 of therapy|Days 7 to 14 of therapy|Of 24 patients enrolled, 3 patients completed first course only due to adverse effects or personal reason. A fourth patient completed both courses but missed blood draws in both courses, precluding calculation of accurate first- and second-phase kinetic parameters. These 4 patient were excluded from analysis.||participants|||Number
740957|NCT00475228|Secondary|To Compare Expulsion Rates Between Immediate Insertion and Delayed Insertion|Compared the expulsion rate of the LNG-IUD in the participants who received the LNG-IUD in the immediate and delayed insertion group|6 months|3 of the 44 participants who had the LNG-IUD placed in Arm 1 underwent an IUD expulsion. 1 of the 20 participants who had the LNG-IUD placed in Arm 2 underwent an IUD expulsion.||percentage of participants|||Number
740958|NCT00475228|Secondary|To Examine the Number of Women Receiving the LNG-IUD in Each Group|The difference between the overall number of women who had the LNG-IUD inserted immediately post D&E successfully (Arm 1) was compared to the overall number of women who had the LNG-IUD inserted 3 -6 weeks post D&E (standard or routine) (Arm 2).|2 Months|In Arm 1, all 44 participants were inserted with an LNG-IUD immediately post D& E successfully. In Arm 2; only 20 of the 44 participants returned and had the LNG-IUD inserted successfully 3 to 6 weeks post D&E.||Completed LNG-IUD Insertions|Completed LNG-IUD Insertions||Number
740959|NCT00475228|Primary|The Primary Outcome is LNG-IUD Usage Six Months Following Enrollment.|"To assess the six-month usage rate of the LNG-IUD when placed immediately after D&E compared to 3-6 weeks later, as measured by the proportion of women with a LNG-IUD in place at six months after the D&E.
We hypothesize that more women receiving immediate insertion will be using the LNG-IUD 6 months after the D&E procedure than women receiving delayed insertion."|6 months|Attempts to contact all participants (Arm 1: 44 women and Arm 2: 44 women) by phone 6 months post D&E were made. For Arm 1, 27 out of 44 women could be reached. For Arm 2; 27 out of the 44 were reached (19 women who returned and had the LNG-IUD placed 3-6 weeks post D&E and 8 women who did not return for the LNG-IUD placement 3-6 post D&E).||percentage of participants||95% Confidence Interval|Number
740960|NCT00475241|Secondary|All of Below Measures Are Taken at the Major Assessment Points.- Beck Depression Inventory-II- Depression Anxiety Stress Scale- Posttraumatic Cognitions Inventory- Client Satisfaction Questionnaire||pre, mid, post, 3 and 6 mo FU||||||
740961|NCT00475241|Secondary|HPA Axis Reactivity Will be Assessed With Collection of Salivary Cortisol at Each Major Assessment. Cortisol Response to Awakening, Our Measure of General Stress Reactivity, Will be Calculated.||pre, mid, post, 3 and 6 mo FU||||||
740962|NCT00475241|Secondary|Psychophysiological Reactivity Will be Assessed Using a Biopac MP-100 Physiology Recording System for Measurement of Heart Rate (Electrocardiography, ECG), Skin Conductance, Respiration, and End-tidal pCO2 (Pre, Mid, Posttreatment, 3 and 6 mo FU).||pre, mid, post, 3 and 6 mo FU||||||
740963|NCT00475241|Primary|Clinician Administered PTSD Scale (Pre & Posttreatment)|Clinician Adminstered PTSD Scale (CAPS) assesses PTSD symptom severity. Scores range from 0 to 136 and higher scores represent more severe symptoms.|PostTreatment (Week 12)|Treatment Completers||units on a scale||Standard Deviation|Mean
740964|NCT00475306|Secondary|Number of Participants With Akathisia|The akathisia outcome was reported as follows: Either development of akathisia as measured using the Short Akathisia Instrument (Vinson DR. Journal of Emergency Medicine. 2006; 31:139-145)or use of rescue medication for treatment of akathisia.The short akathisia instrument briefly measures subjective and objective restlessness.|60 minutes|Only patients who received the investigational medication are included in this analysis. Please see participant flow for details||participants|||Number
740966|NCT00475319|Secondary|Change in Lissamine Green Conjunctival Staining (LGCS) Score From Baseline to Last Observation Carried Forward (LOCF)|LGCS indicates the damage to the conjunctival epithelium. Per the National Eye Institute/Industry Workshop report, the conjunctival sac and the conjunctina was divided into 6 ractions, each of which was given a staining score from 0 to 3, and the total score was calculated(0-18). 0 is better. The CFB to each study time point was compared between the active-drug groups and the placebo group, and LOCF endpoint scores were used to compare the active-drug groups and the placebo group. In each treatment group, baseline scores and those obtained at each study time point were compared.|Baseline, 4weeks|||LGCS score||Standard Deviation|Mean
740967|NCT00475319|Primary|Change in Fluorescein Corneal Staining (FCS) Score From Baseline to Last Observation Carried Forward (LOCF)|FCS indicates the damage to the corneal epithelium. Per the National Eye Institute/Industry Workshop report, the cornea was divided into 5 fractions, each of which was given a staining score from 0 to 3, and the total score was calculated(0-15). 0 is better.The change from baseline (CFB) to LOCF at the end of instillation (LOCF endpoint) was used to analyze dose-response. A general linear model was used to examine if slope parameters were not equal to zero.|Baseline, 4weeks|||FCS score||Standard Deviation|Mean
740968|NCT00475332|Secondary|The Secondary Endpoint Will be to Assess Response Rates and Patterns of Failure in Patients Treated With Bexxar and External Beam Radiotherapy (EBRT).|Tumor response to treatment is measured using the RECIST criteria: Response Evaluation Criteria in Solid Tumors which defines Complete Response, Partial Response, Progressive Disease, and Stable Disease, by using tumor measurements as seen on CT or MRI|2 yr 3 mos|Two patients were enrolled and the study was terminated. No analyses were conducted.||Participants|||Number
740969|NCT00475332|Primary|The Primary Endpoint of the Study Will be to Determine the Feasibility of Combining External Beam Radiotherapy (EBRT) and Bexxar by Assessing the Toxicities Associated With the Treatment.|13 patients will be enrolled initially and followed for 3 months. If less than 10 of these patients reach a grade III or IV toxicity, then 12 more patients will be enrolled and the study will be deemed feasible. If 11 or more of the first group experience grade III/IV toxicity, the trial will stop early.|2 yr 3 mos|Two patients were enrolled and the study was terminated. No analyses were conducted.||Participants|||Number
740970|NCT00475423|Secondary|Change From Baseline in CD19 B Cell Count|Actual values of CD19+ mean B cell count assessed at Weeks 3 and 8, and Months 4, 6, 8, 10 and 12, and last day. The standard reference range for CD19 is 0.05 to 0.35 x10^9/L.|Weeks 3, 8 and Months 4, 6, 8, 10 and 12, and last day|Safety Analysis Population; n=number of participants assessed for the specified parameter at a given visit.||10^9 cells/L||Standard Deviation|Mean
740971|NCT00475423|Secondary|Cluster of Differentiation 19 (CD19) B Cell Count|Value of mean CD19+ B cell count at baseline. The standard reference range for CD19 is 0.05 to 0.35 x10^9/L.|Baseline, Weeks 1, 3, and 8, Follow-up Months 4, 6, 8, 10, and 12, and Last Day|Safety Analysis Population; n (number) = number of participants assessed for the specified parameter at a given visit.||10^9 cells/L||Standard Deviation|Mean
740972|NCT00475423|Secondary|Percentage of Participants With a Therapeutic Response|Number of therapeutic responder participants by CR, PR, MR, or no response (NR) measured at Week 26 and Week 52. CR was defined as no platelet response or no reduction in the dose intensity of concomitant ITP therapy compared with that at screening. PR was defined as at least minor platelet response that enabled a 50% to 99% reduction in the dose intensity of concomitant ITP therapy compared with that at screening. MR was defined as at least minor platelet response that enabled a 1% to 49% reduction in the dose intensity of concomitant ITP therapy compared with that at screening.|Week 26 and Week 52|ITTR Population||percentage participants||95% Confidence Interval|Number
740973|NCT00475423|Secondary|Percentage of Therapeutic Responders|Percentage of participants with a therapeutic response, defined as achieving CR, PR, or MR assessed at Week 26 and Week 52 or hematological response, defined as achieving CR, PR, or MR at Week 8. CR was defined as no platelet response or no reduction in the dose intensity of concomitant ITP therapy compared with that at screening. PR response was defined as at least a minor platelet response that enabled a 50% to 99% reduction in the dose intensity of concomitant ITP therapy compared with that at screening. MR was defined as at least a minor platelet response that enabled a 1% to 49% reduction in the dose intensity of concomitant ITP therapy compared with that at screening.|Week 26 and Week 52|ITTR Population||percentage of participants|||Number
740974|NCT00475423|Secondary|Time to Initiation of New ITP Therapy|Median time in days to initiation of new ITP therapy and/or increase in dose of existing ITP therapy, including date on which decision made in relation to splenectomy, from time of first treatment to Week 52.|Baseline to Week 52|ITTR Population||days||95% Confidence Interval|Median
740975|NCT00475423|Secondary|Time to Inititiation of New ITP Therapy - Percentage of Participants With an Event|Percentage of participants with an event of initiation of new ITP therapy and/or increase in dose of existing ITP therapy, including date on which decision made in relation to splenectomy, from time of first treatment to Week 52.|Week 52|ITTR Population||percentage of participants|||Number
740976|NCT00475423|Secondary|Duration of MR in Participants With Continued MR From Week 8 Until Week 52|Duration of response was assessed in all responders who reached Week 8 and was defined as the time from Week 8 to the end of MR, irrespective of change of treatment. MR was defined as participants registered with ITP in relapse with a platelet count of > 30x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy. Participants registered with chronic ITP with a platelet count of >30x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, with a 50% to 100% reduction in the dose intensity of concomitant ITP therapy compared with that at screening, and with no increase in concomitant ITP therapy or initiation of new ITP therapy.|Week 8 to Week 52|ITTR Population||days||95% Confidence Interval|Median
740977|NCT00475423|Secondary|Duration of PR in Participants With Continued PR From Week 8 Until Week 52|Duration of PR was assessed in all responders who reached Week 8 and was defined as the time from Week 8 to the end of PR, irrespective of change of treatment. PR was defined as platelet counts >50x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy.|Week 8 to Week 52|ITTR Population||days||95% Confidence Interval|Median
741017|NCT00475722|Primary|Adherence to Dietary Goals|Percentage of participants who met 70% of diet goals as outlined in the exchange list|6 months|||percentage of participants meeting goals|||Number
740978|NCT00475423|Secondary|Duration of CR in Participants With Continued CR From Week 8 Until Week 52|Duration of response was assessed in all responders who reached Week 8 and was defined as the time from Week 8 to the end of CR, irrespective of change of treatment. CR was defined as platelet counts >150x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, and with no increase in concomitant ITP therapy or initiation of new ITP therapy.|Week 8 to Week 52|ITTR Population; only participants with a CR at Week 8 were included in the analysis.||days||95% Confidence Interval|Median
740979|NCT00475423|Secondary|Percentage of Participants With Continued CR From Week 8 to Week 52|The number of participants with a durable CR assessed in CR responders whose responses were sustained from Week 8 through to the end of the study or withdrawal, irrespective of change of treatment. CR was defined as platelet counts >150x10^9/L over ≥2 consecutive measurements ≥ 2 weeks apart, but no more than 60 days apart, and with no increase in concomitant ITP therapy or initiation of new ITP therapy.|Week 8 to Week 52|ITTR Population; only participants with a CR at Week 8 were included in the analysis.||percentage of participants|||Number
740980|NCT00475423|Secondary|Time to MR|Time to response was defined as the time from the first infusion to the first date on which MR was achieved. MR was defined as participants registered with chronic ITP with a platelet count of >30x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, with a 50 percent (%) to 100% reduction in the dose intensity of concomitant ITP therapy compared with that at screening, and with no increase in concomitant ITP therapy or initiation of new ITP therapy.|Baseline to Week 52|ITTR Population||days||95% Confidence Interval|Median
740981|NCT00475423|Secondary|Percentage of Participants Who Achieved MR|MR was defined as participants registered with chronic ITP with a platelet count of >30x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, with a 50 to 100% reduction in the dose intensity of concomitant ITP therapy compared with that at screening, and with no increase in concomitant ITP therapy or initiation of new ITP therapy.|Week 52|ITTR Population||percentage of participants|||Number
740982|NCT00475423|Secondary|Time to PR|Time to response was defined as the time from the first infusion to the first date on which PR was achieved. PR was defined as platelet counts > 50x10^9/L over ≥ 2 consecutive measurements ≥ 2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy.|Baseline to Week 52|ITTR Population||days||95% Confidence Interval|Median
740983|NCT00475423|Secondary|Percentage of Participants Who Achieved PR|PR was defined as platelet counts >50x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy.|Week 52|ITTR Population||percentage of participants|||Number
740984|NCT00475423|Secondary|Time to CR|Time to CR was defined as the time from the first infusion to the first date on which CR was achieved. CR was defined as platelet counts >150x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, and with no increase in concomitant ITP therapy or initiation of new ITP therapy. Participants without an event were censored at the date of last assessment.|Baseline to Week 52|ITTR Population||days||95% Confidence Interval|Median
740985|NCT00475423|Secondary|Percentage of Participants Who Achieved CR|CR was defined as platelet counts >150x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, and with no increase in concomitant ITP therapy or initiation of new ITP therapy.|Week 52|ITTR Population||percentage of participants|||Number
740986|NCT00475423|Secondary|Percentage of Participants With Hematological CR, PR, or Minor Response (MR)|Percentage of participants with CR, PR, and MR at Week 8 as evaluated by platelet count where CR is greater than or equal to (≥)150x10^9/L, PR ≥ 50x10^9/L, MR equals (=) 30x10^9/L over 2 consecutive measurements at least 2 weeks apart but no more than 60 days apart with no increase in concomitant therapy or initiation of new ITP therapy.|Week 8|ITTR Population||percentage of participants||95% Confidence Interval|Number
740987|NCT00475423|Primary|Percentage of Participants Achieving a Complete Hematological Response (CR) or Confirmed Partial Hematological Response (PR)|Percentage of participants with an overall response at Week 8 achieving a CR or PR as evaluated by platelets, new or increased Idiopathic Thrombocytopenic Purpura (ITP)-related treatments and corticosteroids given for Adverse Events (AEs). CR was defined as a platelet count of greater than (>) 150x10^9/ liters (L) over at least 2 consecutive measurements at least 2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy. PR was defined as platelet count of >50x10^9/L over at least 2 consecutive measurements at least <2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy. Overall response rate (participants who achieved CR or confirmed PR) was evaluated using platelets, new or increased ITP related treatments, and corticosteroids given for AEs.|Week 8|Intent-to-Treat Replaced (ITTR) Population: participants who received at least 1 dose of study medication, excluded those lost to follow-up before completing treatment (reasons other than disease progression/toxicity) and/or those without documented platelet count of less than or equal to (≤)50x10^9/L within 7 days prior to 1st rituximab infusion.||percentage of participants||95% Confidence Interval|Number
740988|NCT00475501|Secondary|Life Satisfaction|Life Satisfaction: is a written test of psychological well-being that will be performed at baseline, after 3, 6, 9 and 12 months of treatment. This is a 20-point scale, with a possible range of scores from 0 to 20. A higher score represents greater life satisfaction.|baseline, 3 months, 6 months, 9 months, 12 months|||points||Standard Error|Mean
740989|NCT00475501|Secondary|Transrectal Ultrasound Sizing of Prostate|Transrectal ultrasound sizing of prostate will be performed using the B&K Diagnostic System 3535, with 7 mega hertz transrectal probe at baseline and after 6 and 12 months of treatment.|baseline, 6 month, 12 months|||cc||Standard Error|Mean
740990|NCT00475501|Secondary|Dietary Protein Intake|"Dietary protein intake will be assessed using a 3-day food log and subjects will be counseled to increase protein intake if needed using the guide Healthy Ways to Eat More Protein."|baseline, 3 months, 6 months, 9 months, 12 months|||gm/body weight (kg)||Standard Error|Mean
740991|NCT00475501|Secondary|Hematocrit|Hematocrit was assessed as a part of routine blood analysis at the indicated time points.|baseline, 3 months, 6 months, 9 months, 12 months|||% volume||Standard Error|Mean
740992|NCT00475501|Secondary|Benton Judgment of Line Orientation Test|"Benton Judgment of Line Orientation Test is a standardized test with 30 items that is specific for visual spatial cognition. Tests will be administered at baseline, after 3, 6, 9 and 12 months of treatment.
The minimum score is 0, indicating low visual spatial cognition. The maximum score is 30, indicating high visual spatial cognition"|baseline, 3 months, 6 months, 9 months, 12 months|||units on a scale||Standard Error|Mean
740993|NCT00475501|Secondary|Trail-Making Test, Part A|Trail-Making Test, Part A: is a standardized test of cognitive function which specifically assesses working memory, visual processing, visual spatial skills, selective and divided attention, and psychomotor coordination. the test is scored as seconds required to successful completion of the task with a lower score representing better performance. The mean score on test is 30.75 second with a standard deviation of 16.27.|baseline, 3 months, 6 months, 9 months, 12 months|||sec||Standard Error|Mean
740994|NCT00475501|Secondary|30 Minute Recall Portion of Rey Osterrieth Complex Figure (ROCF) Test|"Rey Osterrieth Complex Figure (ROCF) test is a widely used standardized neuropsychological test for assessing visuospatial constructional functions, visuographic memory, and some aspects of planning.
The drawing is scored by a blinded neuropsychologist on a scale of 0 to 30 with 30 representing a perfect drawing."|baseline, 3 months, 6 months, 9 months, 12 months|||units on a scale||Standard Error|Mean
740995|NCT00475501|Secondary|Geriatric Depression Scale|"Geriatric Depression Scale (GDS): This 15-item, yes/no questionnaire will be administered at baseline, after 3, 6, 9 and 12 months of treatment.
The minimum score is 0 = no depressive symptoms The maximum score is 15 = a very high level of depressive symptoms"|baseline, 3 months, 6 months, 9 months, 12 months|||units on a scale||Standard Error|Mean
740996|NCT00475501|Secondary|Lumbar Spine L2-L4 Bone Mineral Density|Dual x-ray absorptiometry (DXA): We will assess bone mineral density (BMD) and body composition using a fan-bean densitometer (Lunar Prodigy, General Electric Medical Systems).|baseline, 12 months|||gm/cc||Standard Error|Mean
740997|NCT00475501|Secondary|Grip Strength kg|Grip strength in the dominant arm will be measured by using a dynamometer. Testing will be performed at baseline, after 3, 6, 9 and 12 months of treatment.|baseline, 3 months, 6 months, 9 months, 12 months|||kg||Standard Error|Mean
740998|NCT00475501|Primary|1 Repetition Maximum (1-RM) Strength Testing|1-RM strength testing for 5 exercises will be performed using dynamic resistance exercise machines. Testing will be performed before treatment (baseline), at 3, 6, 9 and 12 months after treatment.|baseline, 3 months, 6 months, 9 months, 12 months|per protocol||kg||Standard Error|Mean
740999|NCT00475657|Secondary|Stable Disease Rate|Trial terminated - results not analyzed|baseline to measured progressive disease|||participants|||Number
741000|NCT00475657|Secondary|Duration of Response|Trial terminated - results not analyzed|time of response to progressive disease|||months||Standard Deviation|Mean
741001|NCT00475657|Secondary|Progression Free Survival|Trial terminated - results not analyzed|baseline to measured progressive disease|||participants|||Number
741002|NCT00475657|Secondary|Overall Survival|Trial terminated - results not analyzed|baseline to date of death from any cause|||participants|||Number
741003|NCT00475657|Primary|Overall Response Rate|Trial terminated - results not analyzed|baseline to measured progressive disease|||participants|||Number
741004|NCT00475670|Secondary|Overall Survival|The time, in months, from BL to death due to any cause.|BL, Day 1 of Weeks 1, 4, 7, 10, 13, 16, 19, 25, 37, and 52 at the last administration of study treatment, every 24 weeks thereafter until disease progression or death, yearly thereafter up to 2 years after cessation of recruitment|FAS; Cohort A (trastuzumab monotherapy) was closed prematurely due to enrollment difficulties. Therefore, Cohort A included only 3 participants and none of the data from these 3 participants were analyzed for any of the specified endpoints.||months||95% Confidence Interval|Median
741005|NCT00475670|Secondary|Overall Survival - Percentage of Participants Who Died|OS was defined as the time from the date of enrollment to the date of death due to any cause. Participants were censored at the last date recorded in the CRF.|BL, Day 1 of Weeks 1, 4, 7, 10, 13, 16, 19, 25, 37, and 5 at the last administration of study treatment, every 24 weeks thereafter until disease progression or death, yearly thereafter up to 2 years after cessation of recruitment|FAS; Cohort A (trastuzumab monotherapy) was closed prematurely due to enrollment difficulties. Therefore, Cohort A included only 3 participants and none of the data from these 3 participants were analyzed for any of the specified endpoints.||percentage of participants|||Number
741006|NCT00475670|Secondary|Percentage of Participants With Clinical Benefit According to RECIST Guidelines|Clinical benefit was defined as stable disease (SD) for 6 months or longer, or a confirmed overall response of CR or PR. For TLs, SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since the beginning of treatment. For NTLs, SD was synonymous with incomplete response and defined as the persistence of one or more NTLs and/or maintenance of tumor marker level above the normal limits.|BL, Day 1 of Weeks 7, 13, 19, 25, 37, and 52, at the last administration of study treatment, every 24 weeks thereafter until disease progression for up to 6 months after the last participant was recruited|FAS; Cohort A (trastuzumab monotherapy) was closed prematurely due to enrollment difficulties. Therefore, Cohort A included only 3 participants and none of the data from these 3 participants were analyzed for any of the specified endpoints.||percentage of participants||95% Confidence Interval|Number
741007|NCT00475670|Secondary|Time to Treatment Failure|The time, in months, from BL to treatment failure.|BL, Day 1 of Weeks 7, 13, 19, 25, 37, and 52, at the last administration of study treatment, every 24 weeks thereafter until disease progression for up to 6 months after the last participant was recruited|FAS; Cohort A (trastuzumab monotherapy) was closed prematurely due to enrollment difficulties. Therefore, Cohort A included only 3 participants and none of the data from these 3 participants were analyzed for any of the specified endpoints.||months||95% Confidence Interval|Median
741018|NCT00475735|Secondary|Mean Change From Baseline in the Clinical Global Impressions-severity of Illness Scale(CGI-S) Score|"The Clinical Global Impression - Severity of Illness Scale (CGI-S) is administered by a trained investigator who rates the severity of a patient's illness at the time of assessment, relative to the investigator's past experience with patients who have an ADHD diagnosis. The scores range from 1 to 7. Higher numbers correspond to more severe illness.
Data not reported due to failure of primary hypothesis and program termination."|4 weeks of treatment||||||
741008|NCT00475670|Secondary|Percentage of Participants With Treatment Failure|Treatment failure was defined as the time from first study drug infusion to failure. Failure was defined as any of the following: PD, death, withdrawal due to adverse event (AE) or lab abnormality, or refusal of treatment. Participants were censored at the last date recorded in the case report form (CRF) or the date of withdrawal.|BL, Day 1 of Weeks 7, 13, 19, 25, 37, and 52, at the last administration of study treatment, every 24 weeks thereafter until disease progression for up to 6 months after the last participant was recruited|FAS; Cohort A (trastuzumab monotherapy) was closed prematurely due to enrollment difficulties. Therefore, Cohort A included only 3 participants and none of the data from these 3 participants were analyzed for any of the specified endpoints.||percentage of participants|||Number
741009|NCT00475670|Secondary|Progression-Free Survival|The time, in months, from BL to PFS event.|BL, Day 1 of Weeks 7, 13, 19, 25, 37, and 52, at the last administration of study treatment, every 24 weeks thereafter until disease progression for up to 6 months after the last participant was recruited|FAS; Cohort A (trastuzumab monotherapy) was closed prematurely due to enrollment difficulties. Therefore, Cohort A included only 3 participants and none of the data from these 3 participants were analyzed for any of the specified endpoints.||months||95% Confidence Interval|Median
741010|NCT00475670|Secondary|Progression-free Survival (PFS) - Percentage of Participants With Progressive Disease|PFS was defined as the time from day of first study drug infusion until death or PD. Participants were censored at the date of the last tumor assessment.|BL, Day 1 of Weeks 7, 13, 19, 25, 37, and 52, at the last administration of study treatment, every 24 weeks thereafter until disease progression for up to 6 months after the last participant was recruited|FAS; Cohort A (trastuzumab monotherapy) was closed prematurely due to enrollment difficulties. Therefore, Cohort A included only 3 participants and none of the data from these 3 participants were analyzed for any of the specified endpoints.||percentage of participants|||Number
741011|NCT00475670|Secondary|Duration of Response|The time, in months, from when the response (CR or PR) was first noted until the date of documented PD, death, or withdrawal, whichever occurred first. Participants were censored at the date of the last tumor assessment.|BL, Day 1 of Weeks 7, 13, 19, 25, 37, and 52, at the last administration of study treatment, every 24 weeks thereafter until disease progression for up to 6 months after the last participant was recruited|FAS. Duration of response was assessed in participants with a best overall response of CR or PR. Cohort A (trastuzumab monotherapy) was closed prematurely due to enrollment difficulties. Therefore, Cohort A included only 3 participants and none of the data from these 3 participants were analyzed for any of the specified endpoints.||months||95% Confidence Interval|Median
741012|NCT00475670|Secondary|Duration of Response - Percentage of Participants With Progressive Disease or Death|Duration of response was defined as the time from first confirmed CR or PR until death or progressive disease (PD). For TLs, PD was defined as at least a 20% increase in the SLD of the TL, taking as reference the smallest SLD recorded since the beginning of treatment or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of one or more new lesions or unequivocal progression of existing non target non-measurable lesions. Participants were censored at the date of the last tumor assessment.|BL, Day 1 of Weeks 7, 13, 19, 25, 37, and 52, at the last administration of study treatment, every 24 weeks thereafter until disease progression for up to 6 months after the last participant was recruited|FAS. Duration of response was assessed in participants with a best overall response of CR or PR. Cohort A (trastuzumab monotherapy) was closed prematurely due to enrollment difficulties. Therefore, Cohort A included only 3 participants and none of the data from these 3 participants were analyzed for any of the specified endpoints.||percentage of participants|||Number
741013|NCT00475670|Primary|Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) According to the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 Guidelines|CR was defined for target lesions (TLs) as the disappearance of all lesions, and for nontarget lesions (NTLs) as the disappearance of all nontarget nonmeasurable lesions. PR was defined for TLs as at least a 30 percent (%) decrease from baseline (BL) in the sum of longest diameter (SLD) of TLs. 95% confidence interval for one-sample binomial using Pearson-Clopper method.|Baseline (BL); Day 1 of Weeks 7, 13, 19, 25, 37, and 52, at the last administration of study treatment, every 24 weeks thereafter until disease progression for up to 6 months after the last participant was recruited|FAS; Cohort A (trastuzumab monotherapy) was closed prematurely due to enrollment difficulties. Therefore, Cohort A included only 3 participants and none of the data from these 3 participants were analyzed for any of the specified endpoints.||percentage of participants||95% Confidence Interval|Number
741014|NCT00475709|Primary|Characterize the Hemodynamic Performance of the Valve.|"Gradient is the pressure difference from one side of the valve to the other side of the valve. For this study pressure is measured in mmHg.
Mean gradient for each patient is the average of the pressure differences from one side of the valve to the other side of the valve.
Mean gradient for each valve size (19mm, 21mm, 23mm, 25mm, 27mm, 29mm)is the average of the mean gradient for each patient with that valve size."|1 year|Analysis based on per protocol. Eight subjects did not meet eligibility criteria and were excluded from this analysis.||mm Hg||Standard Deviation|Mean
741015|NCT00475709|Primary|Characterize Patient NYHA Functional Classification Status.|"The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life.
Class I. Patients with cardiac disease but without resulting limitation of physical activity.
Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest.
Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest.
Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest.
The Criteria Committee of the New York Heart Association. Nomenclature and Criteria for Diagnosis of Diseases of the Heart and Great Vessels. 9th ed. Boston, Mass: Little, Brown & Co; 1994:253-256."|1 year|Analysis based on per protocol. Eight subjects did not meet eligibility criteria and were excluded from this analysis.||percentage of participants|||Number
741016|NCT00475709|Primary|Late Adverse Event Rates|"Late patient years are calculated from 31 days post-implant to the date of the last follow-up visits (or contact) or adverse events.
Late Patient year calculation:[(Number of late adverse events/sum of late patient years) x 100]"|Events occurring greater than or equal to 31 days post-implant.|Analysis based on per protocol. Eight subjects did not meet eligibility criteria and were excluded from this analysis.||percentage of events/late patient years|||Number
741019|NCT00475735|Secondary|Mean Change From Baseline in the Conners' Adult ADHD Rating Scale - Observer Screening Version (CAARS-O:SV) Total ADHD Symptom Score.|"Conners' Adult ADHD Rating Scale – Observer Screening version (CAARS-O: SV) evaluates DSM-IV-oriented inattention, impulsivity and hyperactivity as well as measures of self-concept. It is a 30-item scale administered by a trained investigator or rater with cue questions. Each item is scored from 0 to 3 with higher scores corresponding to worse symptoms. The total score can range from 0 to 90.
Data not reported due to failure of primary hypothesis and program termination."|4 weeks of treatment||||||
741020|NCT00475735|Secondary|Mean Change From Baseline in the AISRS Hyperactive/Impulsive Subscale Score|"The Adult Attention Deficit Hyperactivity Disorder Investigator Symptom Rating Scale (AISRS) hyperactive/impulsive subscale score consists of 9 items from the original Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) which address hyperactivity and impulsivity. Each item is rated from 0 to 3. The AISRS hyperactive/impulsive subscale score can range from 0 to 27. A higher score corresponds to a worse severity of ADHD hyperactivity/impulsivity.
Data not reported due to failure of primary hypothesis and program termination"|4 weeks of treatment||||||
741021|NCT00475735|Secondary|>/=1-point Improvement in the CGI-S Score|"The Clinical Global Impression - Severity of Illness Scale (CGI-S) is administered by a trained investigator who rates the severity of a patient's illness at the time of assessment, relative to the investigator's past experience with patients who have an ADHD diagnosis. The scores range from 1 to 7. Higher numbers correspond to more severe illness.
Data not reported due to failure of primary hypothesis and program termination."|4 weeks of treatment||||||
741022|NCT00475735|Secondary|>/= 30% AISRS Total Score Responder Rate After 4 Weeks of Treatment;|"The AISRS total score consists of 18 items from the original ADHD-RS which were derived based on DSM-IV criteria for ADHD. The ADHD-RS include 9 items that address symptoms of inattention and 9 items that address symptoms of impulsivity and hyperactivity. Each item is rated from 0 to 3. The AISRS total score can range from 0 to 54. A higher score corresponds to a worse severity of ADHD.
Data not reported due to failure of primary hypothesis and program termination."|after 4 weeks of treatment||||||
741023|NCT00475735|Other Pre-specified|Baseline AISRS|"Baseline values for all treatment groups are equal because
the constrained longitudinal data analysis (cLDA) model was used
(Liang and Zeger, 2000, Sankhyā: The Indian Journal of Statistics, Series B 62, 134–148)."|Baseline|Full Analysis Set (FAS): The FAS included all randomized patients who received at least one dose of study medication. Patients with at least one assessment (baseline or post-randomization) were included in the FAS. Missing data were handled using the data as observed (DAO) approach.||score on scale||Standard Error|Least Squares Mean
741024|NCT00475735|Secondary|Mean Change From Baseline in the AISRS Inattentive Subscale Score After 4 Weeks of Treatment|"The AISRS inattentive subscale score consists of 9 items from the original ADHD-RS which address inattention. Each item is rated from 0 to 3. The AISRS inattentive subscale score can range from 0 to 27. A higher score corresponds to a worse severity of ADHD inattentiveness.
Data not reported due to failure of primary hypothesis and program termination."|after 4 weeks of treatment||||||
741025|NCT00475735|Primary|Mean Change From Baseline in the Adult Attention Deficit Hyperactivity Disorder Investigator Symptom Rating Scale (AISRS) Total Score After 4 Weeks of Treatment|The AISRS total score consists of 18 items from the original Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) which were derived based on Diagnostic and Statistical Manual-4 (DSM-IV) criteria for ADHD. The ADHD-RS include 9 items that address symptoms of inattention and 9 items that address symptoms of impulsivity and hyperactivity. Each item is rated from 0 to 3. The AISRS total score can range from 0 to 54. A higher score corresponds to a worse severity of ADHD.|after 4 weeks of treatment|Full Analysis Set (FAS): The FAS included all randomized patients who received at least one dose of study medication. Patients with at least one assessment (baseline or post-randomization) were included in the FAS. Missing data were handled using the data as observed (DAO) approach.||score on scale||95% Confidence Interval|Least Squares Mean
741026|NCT00475787|Secondary|Medical Outcome Study Short Form Physical Functioning Subscale|For the Physical Functioning subscale, the higher the number the less self-reported limitations in physical function. The computed SF-36 physical function subscale scores range from 2 to 12.|baseline and 5 weeks|||percentage of change||95% Confidence Interval|Mean
741027|NCT00475787|Secondary|Performance of the Timed up and go Test|The Timed Up and Go Test assesses the amount of time it takes an individual to rise from a standard arm chair, walk a distance of 3 meters, and return to the initial position resting against the back of the chair, in this case the measurement was performed utilizing lasers to assess the time to the three meter mark and also the return to sitting in the chair.|baseline and 5 weeks|||percentage of change||95% Confidence Interval|Mean
741028|NCT00475787|Secondary|Oswestry Disability Index (ODI)|Validated measure of disability associated with lower back pain.|baseline and 5 weeks|||percentage of change||95% Confidence Interval|Mean
741029|NCT00475787|Secondary|Medical Outcome Study Short Form 36(SF-36) Bodily Pain|For the Bodily pain subscale, the higher the number the less self-reported pain. The computed SF-36 pain subscale scores range from 2 to 12.|baseline and 5 Weeks|||percentage of change||95% Confidence Interval|Mean
741030|NCT00475787|Primary|Symptoms of Chronic Lower Back Pain as Measured With the Visual Analog Scale (VAS)|"100 mm line with 0 being no pain and 100 mm being the worst pain I can imagine."|Baseline, 5 weeks|||percentage of change from baseline to 5||95% Confidence Interval|Mean
741031|NCT00475852|Other Pre-specified|Number of Patients With Renal Impairment|Renal impairment was defined as a greater than 25% decrease from baseline in the Modification of Diet in Renal Disease calculated glomerular filtration rate.|Study drug initiation to Day 30|The safety population consisted of all randomized patients who received any amount of study medication. For all safety analyses, patients were analyzed according to the treatment actually received. 66 and 68 patients in the nesiritide and placebo groups, respectively, were not included in the safety population.||Participants|||Number
741032|NCT00475852|Other Pre-specified|Cardiovascular Mortality Through Day 30|All deaths were adjudicated by an independent Clinical Events Committee (CEC) and the cardiovascular deaths were classified by the CEC based on the primary causes.|Randomization to Day 30|The safety population consisted of all randomized patients who received any amount of study medication. For all safety analyses, patients were analyzed according to the treatment actually received. 66 and 68 patients in the nesiritide and placebo groups, respectively, were not included in the safety population.||Participants|||Number
741033|NCT00475852|Other Pre-specified|All-Cause Mortality Through Day 180|All deaths were adjudicated by an independent Clinical Events Committee.|Randomization to Day 180|The safety population consisted of all randomized patients who received any amount of study medication. For all safety analyses, patients were analyzed according to the treatment actually received. 66 and 68 patients in the nesiritide and placebo groups, respectively, were not included in the safety population.||Participants|||Number
741034|NCT00475852|Other Pre-specified|All-Cause Mortality Through Day 30|All deaths were adjudicated by an independent Clinical Events Committee.|Randomization to Day 30|The safety population consisted of all randomized patients who received any amount of study medication. For all safety analyses, patients were analyzed according to the treatment actually received. 66 and 68 patients in the nesiritide and placebo groups, respectively, were not included in the safety population.||Participants|||Number
741035|NCT00475852|Secondary|Composite of Cardiovascular Rehospitalization and Cardiovascular Mortality||Randomization to Day 30|The modified intent-to-treat (MITT) population consisted of all randomized patients who received any amount of study medication and was the primary analysis population for all efficacy endpoints. 141 and 162 patients in the nesiritide and placebo groups, respectively, were not MITT population eligible or didn't have outcome measure of interest.||Participants|||Number
741036|NCT00475852|Secondary|Number of Days Alive and Outside the Hospital||Randomization to Day 30|The modified intent-to-treat (MITT) population consisted of all randomized patients who received any amount of study medication and was the primary analysis population for all efficacy endpoints. 182 and 188 patients in the nesiritide and placebo groups, respectively, were not MITT population eligible or didn't have outcome measure of interest.||Days||Standard Deviation|Mean
741037|NCT00475852|Secondary|Composite of Persistent or Worsening Heart Failure and All-Cause Mortality|Clinical manifestations of worsening or persistent decompensated heart failure were defined by at least one of the following: new, persistent or worsening: dyspnea, orthopnea, paroxysmal nocturnal dyspnea, edema, pulmonary basilar rales/crackles, jugular venous distension, renal hypoperfusion with no other apparent cause, or radiologic evidence of worsening heart failure. And was also defined by a new therapy specifically for the treatment of worsening or persistent decompensated heart failure.|Randomization to hospital discharge (up to Day 30)|The modified intent-to-treat (MITT) population consisted of all randomized patients who received any amount of study medication and was the primary analysis population for all efficacy endpoints. 105 and 115 patients in the nesiritide and placebo groups, respectively, were not MITT population eligible or didn't have outcome measure of interest.||Participants|||Number
741038|NCT00475852|Secondary|Overall Well-Being Self-Assessment at 24 Hours After Initiation of Study Drug|Overall well-being was measured by patient self-assessed Likert scale at 24 hours after study drug initiation. The Likert scale is a 7-point ordinal categorical scale (the 7 categories are markedly better, moderately better, minimally better, unchanged, minimally worse, moderately worse, and markedly worse.)|24 hours after study drug initiation|The modified intent-to-treat (MITT) population consisted of all randomized patients who received any amount of study medication and was the primary analysis population for all efficacy endpoints. 200 and 194 patients in the nesiritide and placebo groups, respectively, were not MITT population eligible or didn't have outcome measure of interest.||Participants|||Number
741039|NCT00475852|Secondary|Overall Well-Being Self-Assessment at 6 Hours After Initiation of Study Drug|Overall well-being was measured by patient self-assessed Likert scale at 6 hours after study drug initiation. The Likert scale is a 7-point ordinal categorical scale (the 7 categories are markedly better, moderately better, minimally better, unchanged, minimally worse, moderately worse, and markedly worse.)|6 hours after study drug initiation|The modified intent-to-treat (MITT) population consisted of all randomized patients who received any amount of study medication and was the primary analysis population for all efficacy endpoints. 158 and 147 patients in the nesiritide and placebo groups, respectively, were not MITT population eligible or didn't have outcome measure of interest.||Participants|||Number
741040|NCT00475852|Primary|Dyspnea Self-Assessment at 24 Hours After Initiation of Study Drug|Dyspnea symptoms were measured by patient self-assessed Likert scale at 24 hours after study drug initiation. The Likert scale is a 7-point ordinal categorical scale (the 7 categories are markedly better, moderately better, minimally better, unchanged, minimally worse, moderately worse, and markedly worse.)|24 hours after study drug initiation|The modified intent-to-treat (MITT) population consisted of all randomized patients who received any amount of study medication and was the primary analysis population for all efficacy endpoints. 193 and 179 patients in the nesiritide and placebo groups, respectively, were not MITT population eligible or didn't have outcome measure of interest.||Participants|||Number
741041|NCT00475852|Primary|Dyspnea Self-Assessment at 6 Hours After Initiation of Study Drug|Dyspnea symptoms were measured by patient self-assessed Likert scale at 6 hours after study drug initiation.The Likert scale is a 7-point ordinal categorical scale (the 7 categories are markedly better, moderately better, minimally better, unchanged, minimally worse, moderately worse, and markedly worse.)|6 hours after initiation of study drug|The modified intent-to-treat (MITT) population consisted of all randomized patients who received any amount of study medication and was the primary analysis population for all efficacy endpoints. 148 and 133 patients in the nesiritide and placebo groups, respectively, were not MITT population eligible or didn't have outcome measure of interest.||Participants|||Number
741042|NCT00475852|Primary|Composite of Rehospitalization Due to Heart Failure and All-Cause Mortality||Randomization to Day 30|The modified intent-to-treat (MITT) population consisted of all randomized patients who received any amount of study medication and was the primary analysis population for all efficacy endpoints. 141 and 164 patients in the nesiritide and placebo groups, respectively, were not MITT population eligible or didn't have outcome measure of interest.||Participants|||Number
741043|NCT00475865|Secondary|Pharmacokinetic [PK]: Teriflunomide Plasma Concentration|Plasma concentrations of teriflunomide were measured using validated liquid chromatography-tandem mass spectrometry methods.|24 weeks|All randomized and treated participants who had at least one PK sample. Participants were included in the treatment group according to the drug actually received.||micrograms/mililiter (μg/mL)||Standard Deviation|Mean
741073|NCT00476151|Primary|Placebo vs. Active Comparison of the Change From Average Pain at Baseline to Average Pain at 4 Weeks.|diabetic peripheral neuropathy (DPN) pain is recorded on a numerical rating scale of 0 (no pain) to 10 (worst possible pain) at baseline and the endpoint of 4 weeks.|baseline and 4 weeks treatment|ITT (Intention To Treat) completer population, LOCF (Last Observation Carried Forward) imputation||units on a scale||95% Confidence Interval|Least Squares Mean
741044|NCT00475865|Secondary|Annualized Relapse Rate [ARR]: Poisson Regression Estimates|"ARR is obtained from the total number of confirmed relapses that occured during the treatment period divided by the sum of the treatment durations.
Each episode of relapse - appearance, or worsening of a clinical symptom that was stable for at least 30 days, that persisted for a minimum of 24 hours in the absence of fever - was to be confirmed by an increase in Expanded Disability Status Scale [EDSS] score or Functional System scores.
To account for the different treatment durations among participants, a Poisson regression model with robust error variance was used (total number of confirmed relapses as response variable; log-transformed treatment duration as offset variable; treatment group and region of enrollment as covariates)."|24 weeks|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.||relapses per year||95% Confidence Interval|Number
741045|NCT00475865|Secondary|Cerebral MRI Assessment: Volume of Gd-enhancing T1-lesions Per Scan|Total volume of Gd-enhancing T1-lesions per scan is obtained from the sum of the volumes of Gd-enhancing T1-lesions observed during the study divided by the total number of scans performed during the study.|24 weeks|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.||mililiters per scan|||Number
741046|NCT00475865|Secondary|Cerebral MRI Assessment: Number of Gd-enhancing T1-lesions Per Scan (Poisson Regression Estimates)|"Number of Gd-enhancing T1-lesions per scan is obtained from the total number of Gd-enhancing T1-lesions observed during the study divided by the total number of scans performed during the study.
To account for the different number of scans among participants, a Poisson regression model with robust error variance was used (total number of Gd-enhancing T1-lesions as response variable; log-transformed number of scans as offset variable; treatment group, region of enrollment and baseline number of Gd-enhancing T1-lesions as covariates)."|24 weeks|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.||lesions per scan||95% Confidence Interval|Number
741047|NCT00475865|Secondary|Cerebral Magnetic Resonance Imaging [MRI] Assessment: Change From Baseline in Total Lesion Volume (Burden of Disease)|"Total lesion volume is the sum of the total volume of all T2-lesions and the total volume all T1-hypointense post-gadolinium lesions measured through T2/proton density scan analysis and gadolinium-enhanced T1 scan analysis.
Least-square means were estimated using a Mixed-effect model with repeated measures [MMRM] on cubic root transformed volume data (treatment group, region of enrollment, visit, treatment-by-visit interaction, baseline value (cubic root transformed), and baseline-by-visit interaction as factors)."|baseline (before randomization) and 24 weeks|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.||mililiters (mL)||Standard Error|Least Squares Mean
741048|NCT00475865|Primary|Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA)|"PCSA values are abnormal values considered medically important by the Sponsor according to predefined criteria based on literature review.
Hepatic parameters thresholds were defined as follows:
Alanine Aminotransferase [ALT] >3, 5, 10 or 20 Upper Normal Limit [ULN];
Aspartate aminotransferase [AST] >3, 5, 10 or 20 ULN;
Alkaline Phosphatase >1.5 ULN;
Total Bilirubin [TB] >1.5 or 2 ULN;
ALT >3 ULN and TB >2 ULN."|from first study drug intake up to 112 days after last intake or up to the first intake in the extension study LTS6047, whichever occured first (40 weeks max)|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.||participants|||Number
741049|NCT00475865|Primary|Overview of AE With Potential Risk of Occurrence|"AE with potential risk of occurrence were defined as follows:
Hepatic disorders;
Immune effects, mainly effects on bone marrow and infection;
Pancreatic disorders;
Malignancy;
Skin disorders, mainly hair loss and hair thinning;
Pulmonary disorders;
Hypertension;
Peripheral neuropathy;
Psychiatric disorders;
Hypersensitivity."|from first study drug intake up to 112 days after last intake or up to the first intake in the extension study LTS6047, whichever occured first (40 weeks max)|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.||participants|||Number
741050|NCT00475865|Primary|Overview of Adverse Events (AE]|AE are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.|from first study drug intake up to 112 days after last intake or up to the first intake in the extension study LTS6047, whichever occured first (40 weeks max)|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.||participants|||Number
741051|NCT00475878|Secondary|Depressive Symptoms|Depressive symptoms, as measured by self-report during study interviews, using the Beck Depression Inventory II. Scores ranged from 0-63; higher scores indicate more depressive symptoms.|3 months|participants who were fully eligible for the study, completed the enrollment process and began study medication were included in an intent to treat analysis||units on a scale||Standard Error|Mean
741052|NCT00475878|Primary|Percentage of Participants Who Dropped Out of Buprenorphine Treatment|Drop-out is defined as 7 or more days of missed Buprenorphine doses|3 months|Participants who were fully eligible for the study, completed the enrollment process and began study medication were used in an intent to treat analysis.||percentage of participants|||Number
741053|NCT00475904|Primary|Change in Pain Intensity From Baseline to 28 Days of Treatment, Comparison Between NP-1 Topical Cream and Oral Gabapentin|Change in pain intensity scores between NP-1 cream vs. oral gabapentin for the treatment of the pain of PHN. Baseline pain scores were compared to the pain scores after 28 days of treatment. Pain scores were rated on a 11 point numerical rating scale (0-10) where 0 was no pain and 10 was worst possible pain.|baseline to 28 Days|Intent To Treat (ITT) population using the Last Observation Carried Forward) LOCF imputation technique||units on a scale||95% Confidence Interval|Least Squares Mean
741054|NCT00475904|Primary|Change in Pain Scores Comparing NP-1 Cream vs. Placebo Cream for Treatment of the Pain of Post Herpetic Neuralgia(PHN)From Baseline to 28 Days.|Difference in pain scores between NP-1 cream vs. placebo cream for the treatment of the pain of PHN. Baseline pain scores were compared to the pain scores after 28 days of treatment. Pain scores were rated on a 11 point numerical rating scale (0-10) where 0 was no pain and 10 was worst possible pain.|baseline and 28 days|This analysis was performed for the Intent To Treat (ITT) population using the ast Observation Carried Forward (LOCF) approach.||units on a scale||95% Confidence Interval|Mean
741055|NCT00476008|Secondary|Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)|The ADAS-Cog is a performance based test that measures specific cognitive and behavioral dysfunctions in patients with Alzheimer's disease. The cognitive subscale comprises 11 items which measure word recall (0-10), ability to follow single and multi-step commands (0-5), constructional praxis (0-5), ideational praxis (0-5), naming objects(0-5), word recognition (0-12), orientation (0-8), comprehension of spoken language (0-5), word finding difficulty(0-5) and ability to remember test instructions (0-5). 0 = no impairment with higher scores indicating more severe impairment.|baseline and 12 months|||units on a scale||Standard Deviation|Mean
741056|NCT00476008|Secondary|Cognitive Dementia Rating Scale|This scale is used to stage severity of dementia. Scores are on a five-point scale in which 0 indicates no cognitive impairment, .5 = very mild dementia,1 = mild, 2 = moderate and 3= severe.|baseline and 12 months|||units on a scale||Standard Deviation|Mean
741057|NCT00476008|Secondary|Motor Free Visual Perception Test - Visual Closure Subtest|This is an 11 item multiple choice test of visual perception. Scores range from 0-11. This test measures visual perception deficits separate from motor skill abilities. Higher scores indicate more severe impairment.|baseline and 12 months|||number incorrect||Standard Deviation|Mean
741058|NCT00476008|Secondary|Useful Field of View|The Useful Field of View is a computer-administered test that measures higher order processing skills such as divided attention and visual processing speed. Scores can be predictive of ability to perform many everyday activities, such as driving a vehicle. Speed of visual processing is measured as the examinee identifies a target, but must also localize a simultaneously presented target displayed in the periphery of the computer monitor. Scores range from 1 to 4 with 1 being no impairment, 2= mild, 3= moderate and 4=serious impairment.|baseline and 12 months|||units on a scale||Standard Deviation|Mean
741059|NCT00476008|Secondary|Mini Mental Status Exam|Scores range from 0-30 with lower scores indicating decreased functioning.|baseline and 12 months|||units on a scale||Standard Deviation|Mean
741060|NCT00476008|Secondary|Trail Making Test - Part B|This tests cognitive flexibility and set-shifting. It is considered to be a test of executive functioning and has been shown to correlate with on-road driving ability. The score is the time in seconds required to complete each part. Higher scores indicate decreased functioning.|baseline and 12 months|||seconds||Standard Deviation|Mean
741061|NCT00476008|Secondary|Trail Making Test - Part A|A simple test of visual tracking. The score is the time in seconds required to complete. Higher scores indicate lower functioning.|baseline and 12 months|||seconds||Standard Deviation|Mean
741062|NCT00476008|Secondary|Rey Complex Figure Test|This is a measure of visual-spatial and constructional ability as well as higher order cognitive processes including planning, organizing, and problem solving. Subjects are asked to copy a complicated drawing. 18 elements are scored from 0-2 depending on accuracy/distortion and location of the reproduction. The maximum score is 36 points. Lower scores indicate more severe impairment|baseline and 12 months|||units on a scale||Standard Deviation|Mean
741063|NCT00476008|Secondary|Fuld Object Memory Evaluation|"Ten common objects in a bag were presented to determine whether the subject could identify objects by touch. The subject was not told that memory of this event would be tested. The subject names each object and then pulls it out of the bag to see if he is correct. After distracting the subject, by asking the patient to say words rapidly from a single category (rapid verbal retrieval), the subject is asked to recall the objects from the bag. The subject was then offered two more chances to learn and recall them (store and retrieve) by reminding the subject of omitted items after each recall, with rapid verbal retrieval preventing rehearsal before each recall opportunity.
Retrieval scores were summed over the three trials with the range of possible scores being 0-30. Lower scores indicate more severe impairment."|baseline and 12 months|||units on a scale||Standard Deviation|Mean
741064|NCT00476008|Primary|The Primary Outcome Measure is the Number of Subjects in Each Group Who Are Able to Pass the DriveABLE On-Road Test at Month 12 (Endpoint).|The DriveABLE On-Road Test utilizes a standardized road course and standardized scoring procedures designed to identify driving errors indicative of decline in competence scores. This road test takes approximately 30-45 minutes and covers a distance of approximately 9 miles.|Baseline and 12 months|One subject in the placebo group could not complete the driving test at 12 months due to his vision being below the legal limit to drive.||participants|||Number
741065|NCT00476021|Secondary|Rates of Follow-up and Unintended Pregnancy Rates for Subjects Who Are Excluded From Postpartum Insertion||6 months|||participants|||Number
741066|NCT00476021|Secondary|Safety of Postplacental Insertion of the LNG-IUD as Measured by Infection Rates||6 months|||participants|||Number
741067|NCT00476021|Secondary|Expulsion Rates of Post-placental and Delayed Insertion of the LNG-IUD Using Clinical Exam and Ultrasonography||6 months|The population only includes women who received IUDs at the specified timepoint. Only 50/51 women in the postplacental group had a successful IUD insertion postplacentally. Only 46 of 51 women in the delayed group returned for a delayed IUD insertion.||participants|||Number
741068|NCT00476021|Secondary|Follow-up Rates for Delayed Insertion of LNG-IUD||6 months|||participants|||Number
741069|NCT00476021|Secondary|Proportion of Women Who Are Able to Have the LNG-IUD Placed Postplacentally and Are Not Excluded From Placement||6 months|||participants|||Number
741070|NCT00476021|Primary|IUD Usage Rate at 6 Months|Usage rate of the LNG-IUD at 6 months after delivery|6 months after delivery|IUD use at 6 months, lost to follow-up counted as failures||participants|||Number
741071|NCT00476086|Secondary|Radiation Therapy Completion Rate|Disease was evaluated radiologically at baseline and every X cycles on treatment; Treatment continued if radiological exam showed no progressive disease|Radiation therapy was within 4-6 weeks of last chemotherapy dose. Participants received up to 5 weeks of radiation therapy.|The analysis dataset is comprised of all participants who started chemotherapy.||percentage of participants||90% Confidence Interval|Number
741072|NCT00476086|Primary|Chemotherapy Completion Rate|Feasibility in this study was based on the chemotherapy regimen. The chemotherapy completion rate is defined as the percentage of patients who complete 3 cycles of oxaliplatin and gemcitabine chemotherapy prior to radiation therapy.|3 cycles of chemotherapy which approximates 3 months given the 28-day cycle|The analysis dataset is comprised of all participants who started chemotherapy.||percentage of participants||90% Confidence Interval|Number
741074|NCT00476229|Primary|Composite Success Rate|Defined as the proportions of the patients who are alive at day 100, are without Grade 3-4 Graft Graft-versus-host disease (GVHD), without Grade 4 toxicity (unrelated to infection) and have engrafted. Toxicity grades according to Common Toxicity Criteria (CTC) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0.|Baseline to Day 100, assessment at Day 100|Analysis was per protocol. One participant was inevaluable.||Percentage of participants|||Number
741075|NCT00476242|Secondary|Opiate Craving Based on Heroin Craving Scale||measured daily for 12 weeks of study or length of participation||||||
741076|NCT00476242|Primary|Retention in Treatment The Primary Outcome Measure Will be the Dichotomous Measure Retention in Treatment (Whether the Patient Completes the 12 Week Trial, Yes/no).||Week 12|||participants|||Number
741077|NCT00476242|Primary|Opiate Use Measured by Urine Toxicology Results|Opiate use was qualified by the number of opiate positive urine results.|3x/week during 12 weeks of the trial or study participation|||Percent of total urine samples||Inter-Quartile Range|Median
741078|NCT00476476|Primary|Response Rate|Response is defined as achieving complete or partial response.Complete response (CR) for both cohorts was defined as resolution of all identified tumor masses on the vulva or disappearance of all target and non-target lesions with no evidence of new lesions documented by two disease assessments at least 4 weeks apart. For cohort 1 pts, a partial response (PR) was defined as a 30% reduction in the product of all diameters of the vulva tumor/tumors compared to baseline measurements. For cohort 2 pts, PR defined according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) was at least a 30% decrease in the sum of the longest diameter (LD) of all target measurable lesions (baseline sum LD reference).|Assessed prior to definitive surgery or chemoradiation therapy (cohort 1 pts) or after 2 cycles of therapy (cohort 2 pts).|The analysis dataset is comprised of response evaluable patients.||proportion of participants||90% Confidence Interval|Number
741079|NCT00476593|Primary|Macular Thickness Measured With the OCT; in Relation to Age, Sex, Reproductive Factors and the Use of Anti-inflammatory Eye Drops in Health; in Uncomplicated Anterior Uveitis.|Macular thickness was assessed with the OCT in healthy subjects and in patients with anterior uveitis. Data was analyzed with respect to age, sex, parity, the use of hormonal therapy, after treatment with to types of anti-inflammatory eye drops, and in uncomplicated uveitis.|Macular thickness measured with the OCT|Enrolled healthy subjects and patients with anterior uveitis who volunteered through enrollment period||Macular Thickness in micron||Standard Deviation|Mean
741080|NCT00476645|Secondary|Stable Disease After One Year|Stable disease was defined as continuing treatment without disease progression, with disease progression defined as 3 consecutive rises in serum PSA or objective progression by RECIST criteria.|12 months|||participants|||Number
741081|NCT00476645|Secondary|PSA Doubling Time|Number of subjects with prolongation of PSA doubling time|3 months|||participants|||Number
741082|NCT00476645|Primary|PSA Reduction ≥ 50%|Number of subjects with serum PSA reduction ≥ 50% at 3 months|3 months|All subjects (10 males) had castration-resistant prostate cancer. 6 had recieved prior radical prostatectomy as primary therapy. 4 had received prior chemotherapy. The majority had previously received 2 hormonal therapies. 2 had recieved radiation therapy, and 2 had recieved hormonal monotherapy.||participants|||Number
741083|NCT00476788|Primary|Mean Glycated Hemoglobin (A1c)|Measure of glycemic control (A1c) over preceding 8 weeks. Normal for a patient between ages 1 and 10 years would be 7.0-8.5%.|6.9 months (average)|||percentage of glycated hemoglobin||Standard Deviation|Mean
741084|NCT00476788|Secondary|Number of Reported Adverse Events|adverse events are defined as a change from baseline|6.9 months (average)|||events|||Number
741085|NCT00476827|Secondary|To Assess the Quality of Life During Treatment With This Therapeutic Approach|Due to slow accrual study was prematurely closed and endpoint not analysed|8 to 9 weeks||||||
741086|NCT00476827|Primary|Determining the Safety and Tolerability of Adding Avastin to Single Agent Chemotherapy to Treat Patients With Brain Metastasis Originating From Breast Cancer|Due to slow accrual study was prematurely closed and endpoint not analysed|trial closure|Due to slow accrual study was prematurely closed and endpoint not analysed|||||
741087|NCT00476827|Secondary|Assess the Activity of Avastin When Added to Single Agent Chemotherapy, as Measured by Radiographic Response Rate,Progression Free Survival, and Overall Survival.|Due to slow accrual study was prematurely closed and endpoint not analysed|8 to 9 weeks|Due to slow accrual study was prematurely closed and endpoint not analysed|||||
741088|NCT00476827|Primary|Safety and Tolerability Will be Assessed According to Standard (CTCAE Version 3.0) Toxicity Reporting Criteria.|Primary endpoint has not been analysed secondary to slow and low accrual numbers.|May 2009|Endpoint has not been analysed secondary to slow and low accrual numbers.|||||
741089|NCT00476957|Secondary|Composites of (Cardiac) Death and (Large) Non-fatal Myocardial Infarctions|Total death and large non-fatal myocardial infarctions Total death and non-fatal myocardial infarctions Cardiac death and large non-fatal MI Cardiac death and non-fatal myocardial infarctions|3 years|||participants|||Number
741090|NCT00476957|Primary|To Compare Overall Definite or Probable Stent Thrombosis Rate of the Endeavor® Zotarolimus Eluting Coronary Stent System Versus the Cypher® Sirolimus-eluting Coronary Stent in a Patient Population Requiring Stent Implantation|Definite or probable stent thrombosis rate.|3 years|||participants|||Number
741091|NCT00469833|Secondary|HbA1c Before and After 2 Months of Insulin Treatment to Improve Average Glycemia.|Type 2 diabetic subjects had HbA1c measured before and after 2 months of basal insulin glargine treatment.|2 months|||% glycosylated hemoglobin||Standard Error|Mean
741092|NCT00469833|Primary|Insulin Concentration in Response to a Glucose Clamp and Oral Glucose Ingestion Before and After 2 Months of Insulin Treatment to Improve Average Glycemia.|Subjects had glucose clamps for 270 minutes with serial sampling of blood for measurement of insulin and C-peptide. At 90 minutes into the clamp they consumed 75 g of oral glucose solution. Meal-stimulated insulin secretion was summarized as the mean plasma C-peptide from 90-270 minutes. This outcome measure was compared for each subject before treatment and after 2 months of insulin treatment to lower blood glucose. Subjects were started on 20 units of insulin glargine after their first visit and asked to measure their morning blood glucose daily. The dose of insulin was increased in increments of 4-6 units every 3 days targeting an average morning glucose level of less then 120 mg/dl. After 2 months of treatment the primary outcome was repeated with a second glucose clamp / oral glucose tolerance test, identical to the first.|180 minutes|||pmol/L||Standard Error|Mean
741093|NCT00469833|Primary|C-peptide Concentration in Response to a Glucose Clamp and Oral Glucose Ingestion Before and After 2 Months of Insulin Treatment to Improve Average Glycemia.|Subjects had glucose clamps for 270 minutes with serial sampling of blood for measurement of insulin and C-peptide. At 90 minutes into the clamp they consumed 75 g of oral glucose solution. Meal-stimulated insulin secretion was summarized as the mean plasma C-peptide from 90-270 minutes. This outcome measure was compared for each subject before treatment and after 2 months of insulin treatment to lower blood glucose. Subjects were started on 20 units of insulin glargine after their first visit and asked to measure their morning blood glucose daily. The dose of insulin was increased in increments of 4-6 units every 3 days targeting an average morning glucose level of less then 120 mg/dl. After 2 months of treatment the primary outcome was repeated with a second glucose clamp / oral glucose tolerance test, identical to the first.|180 minutes|||nmol/L||Standard Error|Mean
741094|NCT00469833|Primary|ISR in Response to a Glucose Clamp and Oral Glucose Ingestion Before and After 2 Months of Insulin Treatment to Improve Average Glycemia.|Subjects had glucose clamps for 270 minutes with serial sampling of blood for measurement of insulin and C-peptide. At 90 minutes into the clamp they consumed 75 g of oral glucose solution. Meal-stimulated insulin secretion was summarized as the mean plasma C-peptide from 90-270 minutes. This outcome measure was compared for each subject before treatment and after 2 months of insulin treatment to lower blood glucose. Subjects were started on 20 units of insulin glargine after their first visit and asked to measure their morning blood glucose daily. The dose of insulin was increased in increments of 4-6 units every 3 days targeting an average morning glucose level of less then 120 mg/dl. After 2 months of treatment the primary outcome was repeated with a second glucose clamp / oral glucose tolerance test, identical to the first.|180 minutes|||pmol/min||Standard Error|Mean
741095|NCT00469859|Primary|>80% Inhibition of FLT3 Phosphorylation in a Majority of Post-treatment Trough Time Points|FLT3 inhibition is determined in patients receiving lestaurtinib by measuring FLT3 plasma inhibitory activity (PIA). For PIA predictive modeling, a random effects linear regression model will be used to describe the relationship between PIA and Pharmacokinetic (PK) levels for each of the 5 trough plasma samples collected for each patient|Course 1 day 7, day 14, day 21, and day 28.|||participants|||Number
741096|NCT00469859|Primary|Dose-limiting Toxicity|Number of patients with dose-limiting toxicity (DLT)|28 days|||participants|||Number
741097|NCT00469898|Secondary|Overall Survival||On study date to death|||Months||Full Range|Median
741098|NCT00469898|Secondary|Time to Progression|Time to progression in months|9.9 months (on study date to progression)|Patients who has progression||Months|Participants|Full Range|Median
741099|NCT00469898|Secondary|Number of Patients With Adverse Events|Number of participants with adverse events, according to grade of event, using the NCI Common Toxicity Criteria (version 2.0) grading system to assign a grade to each event|date off treatment or progression of disease, up to 18 weeks|||participants|||Number
741100|NCT00469898|Primary|Patient Response|"Patient response to treatment:
Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started Complete response (CR): disappearance of all target lesions Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD"|1.66 months (average duration, on treatment date to best response date)|||participants|||Number
741101|NCT00477152|Secondary|Post-treatment Gorelick Dehydration Score|Score indicates the number of moderate-to-severe signs/symptoms of dehydration, based on assessment of each of the following 10 patient parameters: general condition, quality of radial pulse, quality of respiration, skin elasticity, eyes, tears, mucous membranes, urine output, heart rate and fingertip capillary refill time. Minimum score = 0; maximum score = 10.|At baseline and at either the end of subcutaneous infusion (mean duration = 5.73 ± 9.15 hr) or emergency department discharge (mean time to discharge = 7.03 ± 7.57 hr)|ITT (all treated patients)||No. moderate/severe symptoms (max = 10)||Standard Deviation|Mean
741102|NCT00477152|Secondary|Number of Attempts Needed to Successfully Place Subcutaneous (SC) Catheter||At end of placement of SC catheter|ITT (all treated patients)||participants|||Number
741103|NCT00477152|Primary|Modified HYLENEX-facilitated Subcutaneous (SC) Rehydration Success|Successfully rehydrated (as medically judged by treating physician) without rescue therapy (ie, without receiving fluids via an alternate route), regardless of emergency department discharge destination|At emergency department discharge (mean time to discharge = 7.03 ± 7.57 hr)|ITT (all treated patients)||participants|||Number
741104|NCT00477152|Primary|HYLENEX-facilitated Subcutaneous (SC) Rehydration Success|Successfully rehydrated (as medically judged by treating physician) without rescue therapy (ie, without receiving fluids via an alternate route), and discharged to home|At emergency department discharge (mean time to discharge = 7.03 ± 7.57 hr)|ITT (all treated patients)||participants|||Number
741105|NCT00477165|Secondary|Urgency Score as a Function of Distending Pressure at the End of the Study|A 500mL polyethylene bag was passed into the rectum, with tubing connected to a barostat, which was controlled by a computer that recorded bag pressure, volume, and corrected volume every second. After 5 minutes, the bag was unfurled with 100mL of air and deflated; with inflations lasting 45 seconds from 0 up to 60 mmHg, increasing by 3 mmHg, and separated by 45-second deflations, subjects rated urgency for bowel movement 30 seconds into each inflation. Urgency score scale: 0=no urgency, 1=threshold urgency, 5=worst imaginable urgency.|Week 8|Participants with available data were included in the analysis.||units on a scale||95% Confidence Interval|Mean
741106|NCT00477165|Secondary|Mean Sensation Score as a Function of Distending Pressure at the End of the Study|A 500mL polyethylene bag was passed into the rectum, with tubing connected to a barostat, which was controlled by a computer that recorded bag pressure, volume, and corrected volume every second. After 5 minutes, the bag was unfurled with 100mL of air and deflated; with inflations lasting 45 seconds from 0 up to 60 mmHg, increasing by 3 mmHg, and separated by 45-second deflations, subjects rated sensation 30 seconds into each inflation. Sensation score scale: 0=no inflation sensation, 1-5=increasing painless sensation, 6=threshold pain, 10=worst imaginable pain.|Week 8|Participants with available data were included in the analysis.||units on a scale||95% Confidence Interval|Mean
741247|NCT00478556|Primary|Preferred Contrast Agent|The primary outcome variable is the taste test when subjects will be asked which preparation they prefer. Possible answers include Onmipaque, Gastroview or neither.|1 Day|Analysis was per protocol||participants|||Number
746152|NCT00520767|Secondary|Time to Treatment Failure||Day 1 of Each Cycle||||||
741107|NCT00477165|Secondary|Change From Baseline in IBS-QOL Score at Week 8|The IBS-QOL is a self-report quality-of-life measure specific to Irritable Bowel Syndrome (IBS) that can be used to assess the impact of IBS and its treatment. The IBS-QOL consists of 34 statements about bowel problems, each with a five-point response scale ranging from 1 (no problems) to 5 (most problems). The individual scores are summed and averaged for a total score, then transformed to a 0-100 scale for ease of interpretation with higher scores indicating better IBS-specific quality of life.|Baseline; Week 8|||units on a scale||95% Confidence Interval|Mean
741108|NCT00477165|Primary|"Count of Participants Who Self-reported Adequate Relief"|Participants were asked weekly to answer subjectively whether weekly adequate relief from IBS symptoms was achieved. Overall response was defined as having achieved adequate relief in at least 3 of the past 6 weeks.|Baseline, weekly for 8 weeks|||Participants|||Count of Participants
741109|NCT00477191|Secondary|Change in the Safety and Tolerability of Etanercept in Patients With Psoriasis and Metabolic Syndrome Over a 6-month Period.|Analyzing the safety and tolerability of Etanercept which is being measured through the number of adverse events related to Entanercept over a 6-month period.|6 months|||number of events|||Number
741110|NCT00477191|Secondary|Change of Endothelial Function by Measurement of Flow-mediated Vasodilation Using the Reactive Hyperemia Index (RHI) in 6 Months|Reactive hyperemia index (RHI) is a measure of endothelial dysfunction using noninvasive peripheral arterial tonometry (PAT). It is a ratio of the post-to-pre occlusion PAT amplitude of the tested arm, divided by the post –to-pre occlusion ratio of the control arm. RHI less than 1.67 is considered sign of endothelial dysfunction. The possible range of scores is 1 to 3 and a lower score has a worse outcome.|6 months|||units on a scale||Standard Deviation|Mean
741111|NCT00477191|Secondary|Change in Plasma Glucose in Subjects With Psoriasis and Metabolic Syndrome|Analyzing the difference in plasma glucose in subjects with Psoriasis and Metabolic Syndrome between baseline and month 6.|6 months|||mg/dl||Standard Deviation|Mean
741112|NCT00477191|Primary|Change in CRP Levels From Baseline to 6 Months of Treatment in Subjects With Psoriasis and Metabolic Syndrome|Analyzing the difference in C reactive protein levels from baseline to month 6 in subjects with Psoriasis and Metabolic Syndrome|6 months|||ng/mL||Standard Deviation|Mean
741113|NCT00477204|Secondary|No Secondary Outcomes|No secondary outcomes were measured as recruitment was insufficient and study was stopped after only 9 subjects completed trial.|6 months||||||
741114|NCT00477204|Primary|Change in LDL-c From Baseline to 6 Months in Subjects With Type 1 Diabetes Taking Vytorin or Zocor.|Change in LDL-c between Zocor and Vytorin treatment in subjects with Type 1 Diabetes measured at baseline to the 6-month study visit.|Baseline to 6 months|Recruitment for this study failed to meet target. Due to the small sample size the analyses of these data were primarily descriptive.||mg/dl||Standard Deviation|Mean
741115|NCT00477230|Primary|Freedom for Symptomatic Episode of Atrial Fibrillation at One Year||One Year|Early study termination before one year.||participants|||Number
741116|NCT00477269|Secondary|Blood Gas Measurement - pH at Baseline and Study Completion|The right heart catheter assessment was performed to assess Blood Gas Measurements in pulmonary hypertension, including pH levels at baseline and Study completion Week 24. The pH scale measures how acidic or basic a substance is. It ranges from 0 to 14. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic.|Baseline, and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.||pH scale||Standard Deviation|Mean
741117|NCT00477269|Secondary|Blood Gas Measurement - Venous Saturation at Baseline and Study Completion|The right heart catheter assessment was performed to assess Blood Gas Measurements in pulmonary hypertension, including Venous Saturation levels at baseline and Study completion Week 24.|Baseline, and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.||percentage of saturation||Standard Deviation|Mean
741118|NCT00477269|Secondary|Blood Gas Measurement - Arterial Saturation at Baseline and Study Completion|The right heart catheter assessment was performed to assess Blood Gas Measurements in pulmonary hypertension, including Arterial Saturation levels at baseline and Study completion Week 24.|Baseline, and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.||percentage of saturation||Standard Deviation|Mean
741119|NCT00477269|Secondary|Blood Gas Measurement - PvO2 at Baseline and Study Completion|The right heart catheter assessment was performed to assess Blood Gas Measurements in pulmonary hypertension, including PvO2 levels at baseline and Study completion Week 24.|Baseline, and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.||mmHg||Standard Deviation|Mean
741120|NCT00477269|Secondary|Blood Gas Measurement - PaCO2 at Baseline and Study Completion|The right heart catheter assessment was performed to assess Blood Gas Measurements in pulmonary hypertension, including PaCO2 levels at baseline and Study completion Week 24.|Baseline, and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.||mmHg||Standard Deviation|Mean
741121|NCT00477269|Secondary|Blood Gas Measurement - PaO2 at Baseline and Study Completion|The right heart catheter assessment was performed to assess Blood Gas Measurements in pulmonary hypertension, including PaO2 levels at baseline and Study completion Week 24.|Baseline, and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.||mmHg||Standard Deviation|Mean
741122|NCT00477269|Secondary|Mean Systemic Vascular Resistance (SVR) at Baseline and Study Completion|The right heart catheter assessment was performed to assess several prognostic hemodynamic variables in pulmonary hypertension, including Systemic Vascular Resistance (SVR). Were assessed when the patient was in a stable hemodynamic rest state (as demonstrated by three consecutive Mean PAP and CO measurements within 10% of each other). PAP was assessed when the patient was breathing ambient air, every 2 minutes whilst breathing Nitric Oxide(NO) (1st and 2nd), 5 min after the end of NO administration, and 15 mins after the end of NO administration. SVR was calculated according to the equation: SVR = (Paorta – Pright atrium)/CO|Baseline, and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.||dyn*s/cm^5||Standard Deviation|Mean
742072|NCT00490490|Secondary|Overall Response Rate (ORR)|"ORR is assessed as the sum of the overall rates of
CR confirmed by positron emission tomography (PET)
CR not confirmed by PET, and
Partial response (PR) negative for progression by PET"|12 weeks|||percentage of participants|||Number
741123|NCT00477269|Secondary|Mean Pulmonary Vascular Resistance (PVR) at Baseline and Study Completion|The right heart catheter assessment was performed to assess several prognostic hemodynamic variables in pulmonary hypertension, including Pulmonary Vascular Resistance (PVR). Were assessed when the patient was in a stable hemodynamic rest state (as demonstrated by three consecutive Mean PAP and CO measurements within 10% of each other). PAP was assessed when the patient was breathing ambient air, every 2 minutes whilst breathing Nitric Oxide(NO) (1st and 2nd), 5 min after the end of NO administration, and 15 mins after the end of NO administration. PVR calculated according to the equation:PVR = (PAP – PCWP)/CO|Baseline, and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.||dyn*s/cm^5||Standard Deviation|Mean
741124|NCT00477269|Secondary|Mean Cardiac Output (CO) at Baseline and Study Completion|The right heart catheter assessment was performed to assess several prognostic hemodynamic variables in pulmonary hypertension, including Cardiac Output (CO). Were assessed when the patient was in a stable hemodynamic rest state (as demonstrated by three consecutive Mean PAP and CO measurements within 10% of each other). PAP was assessed when the patient was breathing ambient air, every 2 minutes whilst breathing Nitric Oxide(NO) (1st and 2nd), 5 min after the end of NO administration, and 15 mins after the end of NO administration.|Baseline, and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.||L/min||Standard Deviation|Mean
741125|NCT00477269|Secondary|Mean Heart Rate (HR) at Baseline and Study Completion|The right heart catheter assessment was performed to assess several prognostic hemodynamic variables in pulmonary hypertension, including Heart Rate (HR). Were assessed when the patient was in a stable hemodynamic rest state (as demonstrated by three consecutive Mean PAP and CO measurements within 10% of each other). PAP was assessed when the patient was breathing ambient air, every 2 minutes whilst breathing Nitric Oxide(NO) (1st and 2nd), 5 min after the end of NO administration, and 15 mins after the end of NO administration.|Baseline, and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.||beats per minute (bpm)||Standard Deviation|Mean
741126|NCT00477269|Secondary|Mean Systolic Arterial Pressure (SAP) at Baseline and Study Completion|The right heart catheter assessment was performed to assess several prognostic hemodynamic variables in pulmonary hypertension, including Systolic Arterial Pressure (SAP). Were assessed when the patient was in a stable hemodynamic rest state (as demonstrated by three consecutive Mean PAP and CO measurements within 10% of each other). PAP was assessed when the patient was breathing ambient air, every 2 minutes whilst breathing Nitric Oxide(NO) (1st and 2nd), 5 min after the end of NO administration, and 15 mins after the end of NO administration.|Baseline, and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.||mmHg||Standard Deviation|Mean
741127|NCT00477269|Secondary|Mean Pulmonary Artery Wedge Pressure (PAWP) at Baseline and Study Completion|The right heart catheter assessment was performed to assess several prognostic hemodynamic variables in pulmonary hypertension, including Pulmonary Arterial Wedge Pressure (PAWP). Were assessed when the patient was in a stable hemodynamic rest state (as demonstrated by three consecutive Mean PAP and CO measurements within 10% of each other). PAP was assessed when the patient was breathing ambient air, every 2 minutes whilst breathing Nitric Oxide(NO) (1st and 2nd), 5 min after the end of NO administration, and 15 mins after the end of NO administration.|Baseline, and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.||mmHg||Standard Deviation|Mean
741128|NCT00477269|Secondary|Mean Pulmonary Artery Pressure (PAP) at Baseline and Study Completion|The right heart catheter assessment was performed to assess several prognostic hemodynamic variables in pulmonary hypertension, including right Pulmonary Arterial Pressure (PAP). Were assessed when the patient was in a stable hemodynamic rest state (as demonstrated by three consecutive Mean PAP and CO measurements within 10% of each other). PAP was assessed when the patient was breathing ambient air, every 2 minutes whilst breathing Nitric Oxide(NO) (1st and 2nd), 5 min after the end of NO administration, and 15 mins after the end of NO administration.|Baseline, and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.||mmHg||Standard Deviation|Mean
741129|NCT00477269|Secondary|Borg Score During the Six Minutes Walk Test at Different Time Periods|Borg Score during Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. During the walk the patient was connected to a portable pulse oximeter via a finger probe. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. Borg Score of Breathlessness was recorded using the following score of 0 to 10, how breathless do you feel? 0 is nothing at all and 10 is maximal breathlessness|Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.||score on a scale||Standard Deviation|Mean
741130|NCT00477269|Secondary|Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods|Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. During the walk the patient was connected to a portable pulse oximeter via a finger probe. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. Heart Rate (bpm) were recorded before the test at resting, at the end of the test and two minutes after the end of the test|Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.||beats per minute (bpm)||Standard Deviation|Mean
741131|NCT00477269|Secondary|Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods|Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. During the walk the patient was connected to a portable pulse oximeter via a finger probe. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. Diastolic blood pressure (mmHg) were recorded before the test at resting, at the end of the test and two minutes after the end of the test|Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.||mmHg||Standard Deviation|Mean
742289|NCT00493012|Secondary|Change in Proinsulin From Baseline to 12 Months||baseline, 12 months|||pmol/l||Standard Deviation|Mean
741132|NCT00477269|Secondary|Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods|Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. During the walk the patient was connected to a portable pulse oximeter via a finger probe. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. Systolic blood pressure (mmHg) were recorded before the test at resting, at the end of the test and two minutes after the end of the test|Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.||mmHg||Standard Deviation|Mean
741133|NCT00477269|Secondary|Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods|Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. During the walk the patient was connected to a portable pulse oximeter via a finger probe. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. The test was terminated if the patient became too distressed or if their SaO2% fell below 60%.|Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.||Percentage of Oxygen Saturation||Standard Deviation|Mean
741134|NCT00477269|Secondary|Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity|PAH assessed according to the WHO classification: Class I Patients with PAH but without resulting limitation of physical activity. Ordinary physical activity does not cause undue dyspnea or fatigue, chest pain or near syncope. Class II Patients with PAH resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity causes undue dyspnea or fatigue, chest pain or near syncope. Class III Patients with PAH resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes undue dyspnea or fatigue, chest pain or near syncope. Class IV Patients with PAH with inability to carry out any physical activity without symptoms. These patients manifest signs of right heart failure. Dyspnea and/or fatigue may even be present at rest. Discomfort is increased by any physical activity.|Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.||number of participants|||Number
741135|NCT00477269|Primary|Change From Baseline of Six Minute Walk Test - Total Duration of Stops at Different Time Periods|The Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. If the patient stopped the duration of each stop was recorded.|Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.||minutes||Standard Deviation|Mean
741136|NCT00477269|Primary|Change From Baseline of Six Minute Walk Test - Number of Stops at Different Time Periods|The Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. Number of stops were recorded for each patient.|Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.||number of stops||Standard Deviation|Mean
741137|NCT00477269|Primary|Change From Baseline of Six Minute Walk Test - Total Distance Walked at Different Time Periods|The Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. Distance <500 meters suggests considerable exercise limitation; Distance 500-800 meters suggests moderate limitation; Distance >800 meters (with no rests) suggests mild or no limitation.|Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.||meters||Standard Deviation|Mean
741138|NCT00477269|Primary|Number of Patients With Adverse Events (AEs), Serious Adverse Events (SAEs) and Death During the Extension|In this analysis patients with all (serious and non -serious) adverse events, and death were reported. See Safety Section.|72 months|No formal statistical analysis was performed in the extension phase of this study so no analysis data sets were defined. All summaries are based on all patients enrolled.||participants|||Number
741139|NCT00477269|Primary|Number of Patients With Adverse Events (AEs), Serious Adverse Events (SAEs) and Death During the Core|In this analysis patients with all (serious and non -serious) adverse events, and death were reported. See Safety Section.|6 months|Safety Population all participants enrolled was included in this population||participants|||Number
741140|NCT00477295|Secondary|Percentage of Participants With EQ-5D Scores at Maintenance Period Visit 1|The European Quality of Life Group 5-Dimension Self-Report Questionnaire (EQ-5D) is a preference based generic health related quality of life (HRQoL) instrument which classifies health states across five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each domain has three levels, they are (1) no problems, (2) some problems, (3) extreme problems. The percentages shown are calculated from the number of subjects at that visit with non-missing data for that score.|Week 31 through Week 83|Intent-to-Treat Population. This was measured using Observed Case (OC). The percentages shown are calculated from the number of subjects at that visit with non-missing data for that score (n=174,196).||Percentage of Participants|||Number
741141|NCT00477295|Secondary|Change From Baseline in SF-36 Aggregate Mental and Physical Component Score at Maintenance Period Visit 1|The Short Form 36 Health and Well-Being Questionnaire (SF-36) is a 36-item generic health related QOL instrument covering the following domains: physical functioning, role-physical,bodily pain, general health, social functioning,role-emotional, mental health, and vitality. It yields a profile of eight scores, one for each domain, and physical and mental health summary measures. Each domain is described by a score ranging from 0 to 100, for a range of total possible scoes of 0-400 for physical and 0-400 for mental. An increase represents an improvement, whereas a decrease reflects a worsening.|Baseline and Maintenance Period Visit 1 (Week 31 to Week 83)|Intent-to-Treat Population. This was measured using Observed Case (OC).||Scores on a Scale||Standard Deviation|Mean
741142|NCT00477295|Secondary|Change From Baseline in QOLIE-31-P Overall Score at Maintenance Period Visit 1|"The Quality of Life in Epilepsy - Problems(QOLIE-31-P) was completed by the patient and contained 30 items covering seven subscales(seizure worry, overall
Quality of Life (QOL),emotional well-being,energy-fatigue, cognition,medication effects and social function) and one item covering health status. It also included seven items addressing overall distress related to each subscale, an item addressing the relative importance of each subscale topic, and an item addressing perception of overall change in QOL at the end of the study. A high score reflects a good QOL. The following scale range is a sample of 1 of the 7 of the subscales:
10 (Best possible quality of life) - 0 (Worst possible quality of life);
Rand Corporation QOLIE-31 Scoring Manual was used. The QOLIE-31 overall score is calculated by summing the product of each scale score times its weight and summing overall all scales."|Baseline and Maintenance Period Visit 1 (Week 31 to Week 83)|Intent-to-Treat Population. This was measured using Observed Case (OC).||Scores on a Scale||Standard Deviation|Mean
741143|NCT00477295|Secondary|Change From Baseline in Bond and Lader VAS Mood Sub-Scores at Maintenance Period Visit 1|"The Bond-Lader Visual Analogue Scale (VAS) is made up of 16 pairs of alternative descriptors of mood and attention at either end of a 10 cm line.
Subjects were asked to rate their feelings at the time of assessment by indicating the point on the line which best represent their mood. Each item was scored by measuring the position relative to the left hand end of the line and levels of anxiety, sedation, and dysphoria were then calculated from the combined scores of selected items. The scores ranged from 0 to 100, with a high score reflecting a high level of anxiety, sedation or dysphoria."|Baseline and Maintenance Period Visit 1 (Week 31 to Week 83)|Intent-to-Treat Population. This was measured using Observed Case (OC).||Scores on a Scale||Standard Deviation|Mean
741144|NCT00477295|Secondary|Change From Baseline in Total ABNAS Score at Maintenance Period Visit 1|The Aldenkamp-Baker Neuropsychological Assessment Scale(ABNAS) is a subject based questionnaire to measure subjective perceived drug-related cognitive impairments. The ABNAS measured seven critical domains of cognition(tiredness/fatigue,hyperexcitability, slowing(mental and motor),memory impairment,attention disorders,impairment of motor coordination, and language disorders). The total score ranged from 0 to 72, with a higher score reflecting a high level of problems.|Baseline and Maintenance Period Visit 1 (Week 31 to Week 83)|Intent-to-Treat Population: All randomized subjects who received at least one dose of study medication. This was measured using Observed Case (OC).||Scores on a Scale||Standard Deviation|Mean
741145|NCT00477295|Secondary|Time to 12-months Seizure Freedom|A subject achieved a 12-month seizure-free period if they were free of all seizures, regardless of seizure type, for 12-months while receiving the same dose. The occurrence of seizures was documented in the seizure diary, which was maintained by the subject and reviewed at each following visit.|Week 5 through Week 83|ITT Population||Days||Standard Deviation|Mean
741146|NCT00477295|Secondary|Time to 6-months Seizure Freedom|A subject achieved a 6-months seizure-free period if they were free of all seizures, regardless of seizure type, for 6-months while receiving the same dose. The occurrence of seizures was documented in the seizure diary, which was maintained by the subject and reviewed at each following visit.|Week 5 through Week 83|Intent-to-Treat (ITT) Population - randomized subjects who received at least one dose of study medication.||Days||Standard Deviation|Mean
741147|NCT00477295|Secondary|Analysis of Time to Drop Out Due to Lack of Efficacy|Lack of efficacy was evaluated by the subject and on the basis of whether zonisamide and carbamazepine gave the subject at least a 26-week seizure free rate. The subject could withdraw at any time due to lack of efficacy.|Week 1 through Week 109|Per Protocol Population||Median Days||Standard Error|Median
741148|NCT00477295|Secondary|Analysis of Time to Drop Out Due to an Adverse Event (AE)|An AE is defined as any untoward medical occurrence in a subject and does not necessarily have a causal relationship with the medicinal product. Adverse events were identified by: any unfavorable or unintended sign, symptom or disease temporarily associated with the use of a medicinal product; any new disease or exacerbation of an existing disease; any deterioration in nonprotocol-required measurements of laboratory values or other clinical test; and recurrence of an intermittent medical condition not present at Baseline.|Week 1 through Week 109|Per Protocol Population||Median Days||Standard Error|Median
741149|NCT00477295|Secondary|Percentage of Participants Who Experienced Seizure Freedom for 12-months During the FDP and Maintenance Period|A subject achieved a 12-month seizure-free period if they were free of all seizures, regardless of seizure type, for 12 months while receiving the same dose. The occurrence of seizures was documented in the seizure diary, which was maintained by the subject and reviewed at each following visit.|Week 5 through Week 109|Per Protocol Population. N=number of subjects with evaluable data.||Percentage of participants|||Number
741150|NCT00477295|Primary|Percentage of Participants Who Experienced Seizure Freedom for 26-weeks During the Maintenance Phase|A subject achieved a 26-week seizure-free period if they were free of all seizures, regardless of seizure type, for 26 weeks while receiving the same dose. The occurrence of seizures was documented in the seizure diary, which was maintained by the subject and reviewed at each following visit.|Week 31 through Week 109|Per Protocol Population: All randomized subjects who received at least one dose of study medication and who had no major protocol violations.||Percentage of Participants|||Number
741151|NCT00477594|Other Pre-specified|High-Density Lipoprotein Cholesterol Over Time|For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study.|Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."||mg/dL||Inter-Quartile Range|Median
741152|NCT00477594|Other Pre-specified|Percent Change From Baseline in High-Density Lipoprotein Cholesterol|High-Density Lipoprotein (HDL) Cholesterol was measured in mg/dL. Samples were taken following an overnight fast.|Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."||percentage of baseline||Inter-Quartile Range|Median
741323|NCT00479557|Secondary|Change From Baseline GMTs of Anti-A-beta IgG Subtypes Using ELISA at Visits Where an IgG Total Response is Measurable (at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 if Applicable)|IgG subtypes were not assessed|Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104||||||
741153|NCT00477594|Other Pre-specified|Apolipoprotein A1 Over Time|For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study.|Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."||mg/dL||Inter-Quartile Range|Median
741154|NCT00477594|Other Pre-specified|Percent Change From Baseline in Apolipoprotein A1|Apolipoprotein A1 was measured in mg/dL. Samples were taken following an overnight fast.|Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."||percentage of baseline||Inter-Quartile Range|Median
741155|NCT00477594|Other Pre-specified|Ratio of Low-density Lipoprotein Cholesterol to High-density Lipoprotein Cholesterol Over Time|For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study.|Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."||ratio||Inter-Quartile Range|Median
741156|NCT00477594|Other Pre-specified|Percent Change From Baseline in Ratio of Low-density Lipoprotein Cholesterol to High-density Lipoprotein Cholesterol||Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."||percentage of baseline||Inter-Quartile Range|Median
741157|NCT00477594|Other Pre-specified|Very-Low-Density Lipoprotein (VLDL) Cholesterol Over Time|For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study.|Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."||mg/dL||Inter-Quartile Range|Median
741158|NCT00477594|Other Pre-specified|Percent Change From Baseline in Very-Low-Density Lipoprotein (VLDL) Cholesterol|Very-Low-Density Lipoprotein (VLDL) Cholesterol was measured in mg/dL. Samples were taken following an overnight fast.|Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."||percentage of baseline||Inter-Quartile Range|Median
741159|NCT00477594|Other Pre-specified|Lipoprotein(a) Over Time|For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study.|Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."||mg/dL||Inter-Quartile Range|Median
741160|NCT00477594|Other Pre-specified|Percent Change From Baseline in Lipoprotein(a)|Lipoprotein(a) was measured in mg/dL. Samples were taken following an overnight fast.|Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."||percentage of baseline||Inter-Quartile Range|Median
741161|NCT00477594|Other Pre-specified|Triglycerides Over Time|For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study.|Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."||mg/dL||Inter-Quartile Range|Median
741162|NCT00477594|Other Pre-specified|Percent Change From Baseline in Triglycerides|Triglycerides were measured in mg/dL. Samples were taken following an overnight fast.|Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."||percentage of baseline||Inter-Quartile Range|Median
741163|NCT00477594|Secondary|Percent Change From Baseline in Respiratory Rate||Baseline and Week 104 or the Early Termination visit for participants who did not complete 2 years of treatment.|Safety set||percentage of baseline||Standard Deviation|Mean
741164|NCT00477594|Secondary|Percent Change From Baseline in Pulse Rate||Baseline and Week 104 or the Early Termination visit for participants who did not complete 2 years of treatment.|Safety set||percentage of baseline||Standard Deviation|Mean
741165|NCT00477594|Secondary|Percent Change From Baseline in Blood Pressure||Baseline and Week 104 or the Early Termination visit for participants who did not complete 2 years of treatment.|Safety set||percentage of baseline||Standard Deviation|Mean
741166|NCT00477594|Secondary|Percent Change From Baseline in Hematology Parameters||Baseline and Week 104 or the Early Termination visit for participants who did not complete 2 years of treatment|Safety set||percentage of baseline||Standard Deviation|Mean
741167|NCT00477594|Secondary|Percent Change From Baseline in Clinical Chemistry Parameters||Baseline and Week 104 or the Early Termination visit for participants who did not complete 2 years of treatment.|Safety set.||percentage of baseline||Standard Deviation|Mean
742290|NCT00493012|Secondary|Change in Tumor Necrosis Factor Alpha From Baseline to 12 Months||baseline, 12 months|||pg/ml||Standard Deviation|Mean
748835|NCT00538642|Secondary|LDL Cholesterol||Baseline|||mg/dL||Standard Deviation|Mean
741168|NCT00477594|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs)|AEs were considered as related if assessed by the Investigator as possibly, probably or definitely related to study drug. The severity of each event was assessed using the following categories: Mild (symptom(s) barely noticeable to the patient or do not make the patient uncomfortable); Moderate (symptom(s) of a sufficient severity to make the patient uncomfortable, performance of daily activities is influenced) or Severe (symptom(s) of a sufficient severity to cause the patient severe discomfort, may cause cessation of treatment with the study drug). Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above.|2 years|Safety set||participants|||Number
741169|NCT00477594|Secondary|Non-High-Density Lipoprotein Cholesterol Over Time|For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study.|Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."||mg/dL||Inter-Quartile Range|Median
741170|NCT00477594|Secondary|Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol|Non-high-density lipoprotein cholesterol was measured in mg/dL. Samples were taken following an overnight fast.|Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."||percentage of baseline||Inter-Quartile Range|Median
741171|NCT00477594|Secondary|Total Cholesterol Over Time|For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study.|Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."||mg/dL||Inter-Quartile Range|Median
741172|NCT00477594|Secondary|Percent Change From Baseline in Total Cholesterol|Total cholesterol was measured in mg/dL. Samples were taken following an overnight fast.|Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."||percentage of baseline||Inter-Quartile Range|Median
741173|NCT00477594|Secondary|Apolipoprotein B Over Time|For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study.|Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."||mg/dL||Inter-Quartile Range|Median
741174|NCT00477594|Secondary|Percent Change From Baseline in Apolipoprotein B|Apolipoprotein B was measured in mg/dL. Samples were taken following an overnight fast. For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study.|Baseline and Weeks 52 and 104|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."||percentage of baseline||Inter-Quartile Range|Median
741175|NCT00477594|Primary|Low-density Lipoprotein Cholesterol (LDL-C) Over Time|Samples were taken following an overnight fast. For patients with triglycerides <400 mg/dL, LDL-C was obtained using Friedewald’s calculation; and for patients with triglycerides ≥400 mg/dL, LDL-C was directly measured by the central laboratory using ultracentrifugation. For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study.|Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."||mg/dL||Inter-Quartile Range|Median
741176|NCT00477594|Primary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)|LDL cholesterol was measured in mg/dL. Samples were taken following an overnight fast. For patients with triglycerides <400 mg/dL, LDL-C was obtained using Friedewald’s calculation; and for patients with triglycerides ≥400 mg/dL, LDL-C was directly measured by the central laboratory using ultracentrifugation. For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study.|Baseline and Weeks 52 and 104|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."||percentage of baseline||Inter-Quartile Range|Median
741177|NCT00477607|Secondary|Total Amount of Prescribed Cisplatin Dose Administered|Maximum cumulative dose of cisplatin (mg/m^2) administered during the course of chemotherapy.|cisplatin treatment period between 10 weeks and up to 16 weeks.|Subjects from the original 39 recruited who had sufficient chemotherapy data recorded to measure cumulative dose.||mg/m^2||Standard Deviation|Mean
742291|NCT00493012|Secondary|Change in C-reactive Protein From Baseline to 12 Months||baseline, 12 months|||mg/l||Standard Deviation|Mean
741178|NCT00477607|Secondary|Malondialdehyde (MDA) Levels|Computed maximum increase relative to baseline for each subject = (max MDA during treatment) - baseline MDA level.|Baseline measurement occurred prior to first cisplatin treatment session. Follow-up measurements occurred up to 3 months after last cisplatin treatment.|Non-missing MDA measurements from 23 subjects in primary outcome analysis||uM=micro-moles/liter||Standard Deviation|Mean
741179|NCT00477607|Primary|Ototoxicity Measurement|"Any American Speech and Hearing Association (ASHA)-significant hearing loss in the Sensitive Region for Ototoxicity frequencies between baseline measurement and any follow-up measurement.
ASHA criteria are defined as
20 decibel (dB) increase at any test frequency,
10 dB increase at any two consecutive test frequencies, or loss of response where there was previously a response at any three test frequencies."|Baseline measurement occurred prior to first cisplatin treatment session. Follow-up measurements occurred up to 3 months after last cisplatin treatment.|Intent-to-treat (ITT)||participants|||Number
741180|NCT00477633|Secondary|Mean Median Duration (Days) of Intracyclic Bleeding & Spotting, Cycles 2-13, MITT Population|"Each IB episode has a unique duration, with 0, 1, 2, 3 or more episodes per cycle. To obtain mean median duration of episodes during a cycle, take the median duration of all episodes in each cycle. If there are no episodes in the cycle, then median duration is undefined/missing for that cycle. 1 episode - median duration = duration of that episode, 2 episodes - median duration = average of 2 durations, more than 2 episodes, calculated in usual way for median of an ordered set of numbers. Once median determined for each cycle/subject, the mean & SD of those quantities calculated."|12 cycles (28 days each), approximately 336 days|MITT Population||Days||Standard Deviation|Mean
741181|NCT00477633|Secondary|Mean Number of Days of Intracyclic Bleeding & Spotting, Cycles 2-13, MITT Population||12 cycles (28 days each), approximately 336 days|MITT Population||Days||Standard Deviation|Mean
741182|NCT00477633|Primary|Pearl Index, 18-35 Years, MITT Population|Pregnancy rate in women 18-35 years old, Pearl Index - number of pregnancies per 100 women-years of treatment|13 cycles (28 days each), approximately 364 days|MITT Population, Subjects Aged 18-35 years||Pearl Index||95% Confidence Interval|Number
741183|NCT00477672|Secondary|Motor Symptoms Change From Baseline (Negative = Improvement)|"Motor symptoms were measured using the change from baseline (Day 1) to Day 42 in the combined score of the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) and Part III (Motor Examination) using the per-protocol (PP) analysis set. The possible total score is 0 to 160 and a negative change in score indicates improvement.
Analysis Method: ANCOVA, and missing data was imputed using LOCF. The UPDRS Parts II+III score was analyzed by constructing 2-sided 95% confidence intervals (CIs) on the difference between each pimavanserin dose group and placebo mean change from baseline. Non-inferiority was concluded if the upper limit of the CI was less than or equal to 5."|Each study visit (i.e. Days 1, 8, 15, 29 and 42)|"This is the Per Protocol population, which includes subjects in the ITT analysis set, who were free of important protocol deviations, as defined before database lock and unblinding. Subjects were analyzed according to the treatment actually received."||Score on UPDRS-II+III||95% Confidence Interval|Least Squares Mean
741184|NCT00477672|Primary|Antipsychotic Efficacy|"Antipsychotic Efficacy was defined as a decrease in the severity and/or frequency of hallucinations and/or delusions. This is measured as the change from baseline (Day 1) to Day 42 in the Scale for the Assessment of Positive Symptoms - Hallucinations and Delusions scales (SAPS-H+D) score for the ITT Analysis Set. The possible total score is 0 to 100 and a negative change in score indicates improvement.
Analysis Method: Analysis of Covariance (ANCOVA) and missing data was imputed using Last Observation Carried Forward (LOCF) method."|Each study visit (i.e. Days 1, 8, 15, 29 and 42)|"This is the Intent to Treat population, defined as patients who received at least one dose of study drug, and had both the baseline SAPS assessment and at least one post-baseline SAPS assessment."||Score on the SAPS H+D scale||95% Confidence Interval|Least Squares Mean
741185|NCT00477685|Primary|Preoperative and Postoperative Intraocular Pressure|The preoperative and postoperative intraocular pressure is measured as mmHg at baseline and 90 days.|baseline and 90 days|||mm Hg||Standard Deviation|Mean
741186|NCT00477685|Secondary|Number of Participants With Any Complications or Adverse Events.|Observation of the incidence of complications, including transient shallow anterior chamber, hyphema, choroidal detachment, hypotony or endophthalmitis.|180 day|||participants|||Number
741187|NCT00477750|Secondary|Patients With Grade 3 or Higher Adverse Events|Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0.|Every cycle during treatment||||||
741188|NCT00477750|Secondary|Duration of Response (DOR)|Duration of response was calculated from documentation of first response to date of progression in the subset of patients who responded. Patients without progression were censored at the date of last tumor evaluation.|from first response to progression or death (up to 3 years)||||||
741189|NCT00477750|Secondary|Overall Survival (OS)|OS was defined as the time from registration to death due to any cause. Patients who were alive were censored at date of last follow-up.|registration to death (up to 3 years)||||||
741190|NCT00477750|Secondary|Time to Progression (TTP)|TTP was defined as the time from registration to disease progression. Patients who died were considered to have disease progression at time of death unless documented evidence clearly indicates no progression has occurred|registration to progressive disease (up to 3 years)||||||
741191|NCT00477750|Primary|Patients With Overall Confirmed Response|"Response that was confirmed on 2 consecutive evaluations. >
Complete Response (CR): Complete disappearance of M-protein from serum and urine on immunofixations, normalization of Free Light Chain (FLC) ratio and <=5% plasma cells in bone marrow >
Very Good Partial Response (VGPR): >=90% reduction in serum M-spike, Urine M-spike <100mg per 24 hours >
Partial Response (PR): >=50% reduction in serum M-spike, Urine M-spike >=90% reduction or < 200mg per 24 hours, or >=50% decrease in difference between involved and uninvolved FLC levels or 50% decrease in bone marrow plasma cells"|Every cycle during treatment|||participants|||Number
741192|NCT00477971|Post-Hoc|3-Year Progression Free Survival|"Percentage of patients who were progression free at 3 years. The 3-year progression free rate was estimated using the Kaplan Meier method.
Progression is assessed when one of the following occur:
reappearance of monoclonal protein by immunofixation,
Increase in serum monoclonal paraprotein to >25% above the lowest response level,
Increase in urine M-protein to > 25% above the lowest remission value for 24-hour excretion."|3 years|||percentage of participants||95% Confidence Interval|Number
742292|NCT00493012|Secondary|Change in LDL-cholsterol From Baseline to 12 Months||baseline, 12 months|||mmol/l||Standard Deviation|Mean
741193|NCT00477971|Secondary|Organ Response to Treatment|"Organ response was evaluated on the basis of improvement of one or more affected organ; only one parameter was required to satisfy the criteria. Response needed to be maintained for a minimum of 3 months to be considered valid.
Renal response required a 50% reduction in 24-hour urine protein excretion (at least 0.5 g/d) with stable creatinine. Cardiac response required one of >= 2-mm reduction in the interventricular septal (IVS) thickness by echocardiogram, or improvement of ejection fraction by >= 20%, or improvement by 2 NYHA classes without an increase in diuretic use. Hepatic response required either >= 50% decrease in (or normalization of) an initially elevated alkaline phosphatase level or reduction in the size of the liver by at least 2 cm by radiographic determination. Gastrointestinal tract improvement was defined as normalization of a low serum carotene level, or reduction of diarrhea to < 50% of previous movements/day, or decrease in fecal fat excretion by 50%."|10 years|||percentage of participants||95% Confidence Interval|Number
741194|NCT00477971|Secondary|3 Year Overall Survival|Percentage of patients who were alive at 3 years. The 3-year survival rate was estimated using the Kaplan Meier method.|3 years|||percentage of participants||95% Confidence Interval|Number
741195|NCT00477971|Primary|Hematologic Response Rate|"Response that was confirmed on 2 consecutive evaluations during treatment. A hematologic response consisted of a Complete response, Very Good Partial Response or Partial Response.
Complete Response (CR): Complete disappearance of M-protein from serum and urine on immunofixation, normalization of Free Light Chain (FLC) ratio and <5% plasma cells in bone marrow.
Very Good Partial Response (VGPR): >=90% reduction in serum M-component; Urine M-Component <=100 mg per 24 hours.
Partial Response (PR): >=50% reduction in serum M-component and/or Urine M-Component >=90% reduction or <200 mg per 24 hours; or >=50% decrease in difference between involved and uninvolved FLC levels."|10 years|||percentage of participants||95% Confidence Interval|Number
741196|NCT00478023|Secondary|Sum of Pain Intensity Differences Relative to the Baseline Pain Intensity|"Pain Intensity assessed at predefined time points over a 48 hour period using an 11-point Numeric Rating Scale (NRS) where a score of zero indicates no pain and a score of ten indicates pain as bad as you can imagine. Differences calculated as [baseline-post baseline] at each predefined time point. The theoretical maximum range of Sum of pain intensity differences (SPID48) is from -480 (indicative of an increase in pain) to 480 (indicative of a decrease in pain, assuming patients start with a baseline value of 10 and all subsequent values will be 0)."|Baseline value to 48 hours after first study drug intake.|Intention to treat (ITT) and Last Observation Carried Forward (LOCF), i.e. all randomized subjects who received any amount of Investigational Medicinal Product (IMP = study drug) and had a non missing baseline pain assessment.||units on scale||Standard Deviation|Mean
741197|NCT00478023|Primary|Sum of Pain Intensity Differences Relative to the Baseline Pain Intensity.|"Pain Intensity assessed at predefined time points over a 24 hour period using an 11-point Numeric Rating Scale (NRS) where a score of zero indicates no pain and a score of ten indicates pain as bad as you can imagine. Differences calculated as [baseline-post baseline] at each predefined time point. The theoretical maximum range of Sum of pain intensity differences (SPID24) is from -240 (indicative of an increase in pain) to 240 (indicative of a decrease in pain, assuming patients start with a baseline value of 10 and all subsequent values will be 0)."|Baseline to 24 hours after first intake of study drug|Intention to Treat (ITT) and Last Observation Carried Forward (LOCF), i.e. all randomized subjects who received any amount of Investigational Medicinal Product (IMP = study drug) and had a non missing baseline pain assessment.||units on scale||Standard Deviation|Mean
741198|NCT00478036|Primary|Interocular Pressure|IOP, measured by Goldmann applanation tonometry|8 weeks|Reported for subjects for whom all IOP values were available for all of the visits.||mmHg||Standard Deviation|Mean
741199|NCT00478140|Secondary|Overall Survival|Length of time from date of starting treatment that participants are still alive|Up to 3.5 years||||||
741200|NCT00478140|Secondary|Toxicity Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0|Participant toxicity for study as assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 reported in Results Adverse Event Reporting of record.|Up to 3 years||||||
741201|NCT00478140|Secondary|Disease Control Rate|Percentage of participants who have achieved complete response, partial response and stable disease|Up to 3.5 years||||||
741202|NCT00478140|Primary|Objective Response (Complete and Partial Response)|Response assessed using imaging-based evaluation at baseline then following single agent trastuzumab administered over 21 day cycle, re-staging done following 2 cycles. Response Evaluation Criteria in Solid Tumors defined as Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in sum of longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Baseline to 63 days or until disease progression|Only those participants who had measurable disease present at baseline, received at least one cycle of therapy, and had disease re-evaluated considered evaluable for response; therefore one participant was inevaluable.||participants|||Number
741203|NCT00478192|Secondary|Change From Baseline in Free Water Clearance (FWC) at Each Time Point Through the 48-hour Assessment|"Free water clearance (FWC) was calculated as FWC=V(1-Uosm/Posm), where V is urine volume, Uosm is the urine osmolality, Posm is the plasma sodium osmolality.
Baseline is the average of the two most recent serum sodium levels prior to start of dosing on day 1.
Hour 48: Hour 48 or time that ended study participation prior to the hour 48 assessment.
Change is calculated as Actual Data for each time point – Baseline"|Baseline, Hour 24 and Hour 48|"Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and who had baseline serum sodium data.
The number of participants analyzed per arm represents FAS. The numbers of participants for each visit are noted in the category titles."||mL||Standard Deviation|Mean
741228|NCT00478231|Secondary|Percentage of Participants With at Least 1.0 Log 10 Reduction in HIV-1 RNA||Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT|The FAS included all the participants who had taken at least one dose of the study drug and provided any post-baseline efficacy evaluation. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively. Missing data was imputed using LOCF.||Percentage of participants|||Number
741204|NCT00478192|Secondary|Change From Baseline in Effective Water Clearance (EWC) at Each Time Point Through the 48-hour Assessment|"Effective water clearence (EWC) was calculated as EWC=V(1-(Una+Uk)/(Pna+Pk)), where V is urine volume, Una is the urine sodium concentration, Uk is the urine potassium concentration, Pna is the serum/plasma sodium concentration, an Pk is the serum /plasma potassium concentration.
Baseline is the average of the two most recent serum sodium levels prior to start of dosing on day 1.
Hour 48: Hour 48 or time that ended study participation prior to the hour 48 assessment.
Change is calculated as Actual Data for each time point – Baseline"|Baseline, Hour 12, Hour 24,Hour 36 and Hour 48|"Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and who had baseline serum sodium data.
The number of participants analyzed per arm represents FAS. The numbers of participants for each visit are noted in the category titles."||mL||Standard Deviation|Mean
741205|NCT00478192|Secondary|Baseline –Adjusted Area Under the Curve (AUC) in Serum Sodium Over the Duration 0 to 48 Hours|"Each individual subject's change from baseline serum sodium levels was used to calculate baseline adjusted area under the curve serum sodium levels for a duration of Time 0 to Time t in hours (labeled as AUC(Na)(0-t). The last available serum sodium level prior to dosing on Day 1 was used as baseline.
t=48 Hours"|48 Hours|Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and who had baseline serum sodium data.||Hour * mEq/L||Standard Deviation|Mean
741206|NCT00478192|Secondary|Number of Patients With Confirmed Serum Sodium Level Increase >6 mEq/L From Baseline or Confirmed Normal Serum Sodium Level (>135 mEq/L) Over the Duration 0 to 48 Hours|Confirmed sodium levels refers to two consecutive increases from baseline in sodium of >6 mEq/L or two consecutive measurements >135 mEq/L; baseline is the average of the two most recent serum sodium levels prior to start of dosing on day 1.|48 Hours|Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and who had baseline serum sodium data.||Patients|||Number
741207|NCT00478192|Secondary|Number of Patients With Confirmed Serum Sodium Level > 4 mEq/L Increase From Baseline Over 0 to 48 Hours|Confirmed sodium levels refers to two consecutive increases from baseline in sodium of >4 mEq/L; baseline is the average of the two most recent serum sodium levels prior to start of dosing on day 1.|48 Hours|Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and who had baseline serum sodium data.||Patients|||Number
741208|NCT00478192|Secondary|Time From the First Dose of Study Medication to a Confirmed >4 mEq/L Increase From Baseline in Serum Sodium|"Confirmed sodium levels refers to two consecutive increases from baseline in sodium of >4 mEq/L; baseline is the average of the two most recent serum sodium levels prior to start of dosing on day 1.
The endpoint was not evaluable in the placebo arm (median and interquartile range cannot be estimated) or the conivaptan QD arm (interquartile range cannot be estimated) because too high a percentage of patients were censored for the event. Only the conivaptan BID arm will be reported."|48 Hours|Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and who had baseline serum sodium data.||Hours||Inter-Quartile Range|Median
741209|NCT00478192|Secondary|Change From Baseline in Serum Sodium Level at Each Time Point Through the 48 Hour Assessment|"Baseline is the average of the two most recent serum sodium levels prior to start of dosing on day 1.
Hour 48: Hour 48 or time that ended study participation prior to the hour 48 assessment.
Change is calculated as Actual Data for each time point - Baseline"|Baseline, Hour 4, Hour 12, Hour 16, Hour 24, Hour 28, Hour 36, Hour 40 and Hour 48|"Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and who had baseline serum sodium data.
The number of participants analyzed per arm represents FAS. The numbers of participants for each visit are noted in the category titles."||mEq/L||Standard Deviation|Mean
741210|NCT00478192|Primary|Change in Serum Sodium From Baseline to the 48 Hour Assessment or Study Drug Discontinuation.|"Baseline is the average of the two most recent serum sodium levels prior to start of dosing on day 1.
Hour 48: Hour 48 or time that ended study participation prior to the hour 48 assessment.
Change is calculated as Hour 48 - Baseline."|Baseline and 48 hours|"Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and who had baseline serum sodium data.
The number of participants analyzed per arm represents FAS. The numbers of participants for each visit are noted in the category titles."||mEq/L||Standard Deviation|Mean
741211|NCT00478205|Primary|Overall Change From Baseline in Modified CIBIC+ to Week 24|The CIBIC+ is a rating scale derived from an interview with the patient and caregiver with an independent rater designed to measure several domains of patient function, such as mental/cognitive state, behavior, and activities of daily living. The scores range from 1 (marked improvement) to 7 (marked worsening).|Baseline and Week 24|ITT population, LOCF||Scores on a scale||Standard Deviation|Mean
741212|NCT00478205|Secondary|Change From Baseline to Week 24 in MMSE Total Score|The MMSE (Mini-Mental State Examination) is a 30-item test that evaluates 5 domains of cognitive function (orientation to time and place, immediate and delayed recall, attention, calculation, and language). The scores range from 0 (most impaired) to 30 (no impaiment).|Baseline and Week 24|ITT population, LOCF||Scores on a scale||Standard Deviation|Mean
741213|NCT00478205|Secondary|Change From Baseline to Week 24 in ADCS-ADL Total Score|The ADCS-ADL (Alzhemier's Disease Cooperative Study-Activities of Daily Living) is a 19-item assessment scale used to measure a patient's basic functional abilities, such as walking, grooming, and bathing.Scores range from 0 to 54, with a higher score indicating greater functional ability.|Baseline and Week 24|ITT population, LOCF||Scores on a scale||Standard Deviation|Mean
741214|NCT00478205|Primary|Change From Baseline to Week 24 in SIB Total Score|The SIB is an assessment of cognitive dysfunction across nine domains such as memory, language, and orientation. The score ranges from 0 (worst) to 100 (best). This outcome was calculated using the LOCF (last observation carried forward) method.|Baseline and Week 24|Intent-to-treat (ITT) population: All Randomized patients in Safety Population and Severe Impairment Battery (SIB) or Clinician Interview-Based Impression of Severity Plus Caregiver Input (CIBIS+) data available at Baseline and SIB or Clinician Interview-Based Impression of Change Plus caregiver Input (CIBIC+ ) data available post-Baseline; LOCF||Scores on a scale||Standard Error|Least Squares Mean
741215|NCT00478218|Secondary|Duration of Response (DOR)|Duration of response was calculated from the documentation (date) of first response (CR, VGPR, or PR) until the date of progression or last follow-up in the subset of patients who responded. The median DOR with 95%CI was estimated using the Kaplan Meier method.|up to 5 years|Participants who achieved a partial response(PR) or better were evaluable for this analysis.||months||95% Confidence Interval|Median
748836|NCT00538642|Secondary|HDL Cholesterol||4-5 months|||mg/dL||Standard Deviation|Mean
741216|NCT00478218|Secondary|Progression-free Survival (PFS)|"PFS was defined as the time from registration to progression or death due to any cause. The median PFS with 95%CI was estimated using the Kaplan Meier method. > Progression was defined as any one or more of the following: > An increase of 25% from lowest confirmed response in: >
Serum M-component (absolute increase >= 0.5g/dl) >
Urine M-component (absolute increase >= 200mg/24hour >
Difference between involved and uninvolved Free Light Chain levels (absolute increase >= 10mg/dl >
Bone marrow plasma cell percentage (absolute increase of >=10%)"|up to 5 years|||months||95% Confidence Interval|Median
741217|NCT00478218|Secondary|Overall Survival (OS)|OS was defined as the time from registration to death of any cause. Participants were followed for a maximum of 5 years from randomization. The median OS with 95%CI was estimated using the Kaplan Meier method.|up to 5 years|||months||95% Confidence Interval|Median
741218|NCT00478218|Primary|Number of Participants Who Achieved a Confirmed Response (CR), Very Good Partial Response (VGPR) or Partial Response (PR) During Treatment|"Response that was confirmed on 2 consecutive evaluations during treatment
Complete Response(CR): Complete disappearance of M-protein from serum & urine on immunofixation, normalization of Free Light Chain (FLC) ratio & <5% plasma cells in bone marrow (BM)
Very Good Partial Response(VGPR): >=90% reduction in serum M-component; Urine M-Component <100 mg per 24 hours; <=5% plasma cells in BM
Partial Response PR): >= 50% reduction in serum M-Component and/or Urine M-Component >= 90% reduction or <200 mg per 24 hours; or >= 50% decrease in difference between involved and uninvolved FLC levels"|Duration of Treatment (up to 5 years)|||participants|||Number
741219|NCT00478231|Other Pre-specified|Number of Participants With Genotype Resistance|Evolution in resistance to OBT was shown by emergence of new primary or secondary resistance mutations to nucleoside reverse transcriptase inhibitor (NRTI), non-nucleoside reverse transcriptase inhibitor (NNRTI) and protease inhibitor (PI).|Baseline through Week 96|FAS included all the participants who had taken at least one dose of the study drug and provided any post-baseline efficacy evaluation. Here, the 'N = 167' is signifying those participants who were evaluable for this measure at the specified time point for this arm group.||Participants|||Number
741220|NCT00478231|Other Pre-specified|Time to Virologic Failure (VF)|Virologic failure was defined as failing to achieve a reduction in HIV-1 RNA of at least 0.5 log10 copies/ml from baseline by the second viral load determination; or experiencing at least 0.5 log10 increase from nadir in HIV-1 RNA after achieving an HIV-1 RNA reduction from baseline more than 0.5 log10 copies/ml; or experiencing an HIV-1 RNA more than 1000 copies/ml after having achieved an HIV-1 RNA below level of quantification.|Baseline to Week 96 or EOT|The FAS included all the participants who had taken at least one dose of the study drug and provided any post-baseline efficacy evaluation.||Days||95% Confidence Interval|Median
741221|NCT00478231|Other Pre-specified|Change From Baseline in Human Immunodeficiency Virus (HIV) -1 Viral Load (Ribonucleic Acid [RNA]) at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT|Change from baseline in log 10-transformed plasma viral load (HIV-1 RNA) levels (log 10 copies per milliliter [log10 copies/ml]).|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT|The FAS included all participants who had taken at least one dose of study drug and provided any post-baseline efficacy evaluation. The 'n' signifies those participants who received study drug and were evaluated for this measure at time point for each group respectively. Missing data was imputed using LOCF.||log 10 copies/ml||Standard Deviation|Mean
741222|NCT00478231|Secondary|Number of Participants With C-X-C Chemokine Receptor Type 4 {CXCR4} [X4] Tropism Status|Virus tropism was done by the Monogram Biosciences Trofile assay.|Time of virologic failure (VF) and Week 96 or EOT|The FAS included all the participants who had taken at least one dose of the study drug and provided any post-baseline efficacy evaluation. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively.||Participants|||Number
741223|NCT00478231|Secondary|Change From Baseline in CD8 Percent at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT||Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT|The FAS included all the participants who had taken at least one dose of the study drug and provided any post-baseline efficacy evaluation. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively. Missing data was imputed using LOCF.||Percent CD8||Standard Deviation|Mean
741224|NCT00478231|Secondary|Change From Baseline in CD4 Percent at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT||Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT|The FAS included all the participants who had taken at least one dose of the study drug and provided any post-baseline efficacy evaluation. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively. Missing data was imputed using LOCF.||Percent CD4||Standard Deviation|Mean
741225|NCT00478231|Secondary|Change From Baseline in Lymphocyte Cluster of Differentiation 8 (CD8) Count at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT||Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT|The FAS included all the participants who had taken at least one dose of the study drug and provided any post-baseline efficacy evaluation. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively. Missing data was imputed using LOCF.||cells/µL||Standard Deviation|Mean
741226|NCT00478231|Secondary|Change From Baseline in Lymphocyte Cluster of Differentiation 4 (CD4) Count at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT||Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT|The FAS population included all the participants who had taken at least one dose of the study drug and provided any post-baseline efficacy evaluation. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively. Missing data was imputed using LOCF.||cells per microliter (cells/µL)||Standard Deviation|Mean
741227|NCT00478231|Secondary|Percentage of Participants Achieving HIV-1 RNA Below Limit of Quantification|Below limit of quantification was defined as less than 400 copies/milliliter (mL)|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT|The FAS included all the participants who had taken at least one dose of the study drug and provided any post-baseline efficacy evaluation. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively. Missing data was imputed using LOCF.||Percentage of participants|||Number
741229|NCT00478231|Secondary|Percentage of Participants With at Least 0.5 Log 10 Reduction in Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA)||Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or end of treatment (EOT)|The full analysis set (FAS) included all participants who had taken at least one dose of study drug and provided any post-baseline efficacy evaluation. The 'n' signifies those participants who received study drug and were evaluated for this measure at time point for each group respectively. Last Observation Carried Forward (LOCF) method was used.||Percentage of participants|||Number
741230|NCT00478231|Primary|Number of Participants With Laboratory Test Abnormalities|Pre-defined criteria based on upper limit normal (ULN) and lower limit normal (LLN) were established for each laboratory test to define the values that would be identified as laboratory test abnormality.|Baseline to 30 days post-week 96 or ET|The safety analysis set composed of all participants who received at least one dose of study medication.||Participants|||Number
741231|NCT00478231|Primary|Number of Participants With Category C Acquired Immunodeficiency Syndrome (AIDS) Related Infections|Number of participants with AIDS-related infections based on investigator classification guided by a predefined list of clinical Category C AEs per Center for Disease Control (CDC) HIV Classification System.|Baseline to 30 days post-week 96 or ET|The safety analysis set composed of all participants who received at least one dose of study medication.||Participants|||Number
741232|NCT00478231|Primary|Number of Participants With Treatment Emergent Malignancies||Baseline to 30 days post-week 96 or ET|The safety analysis set composed of all participants who received at least one dose of study medication.||Participants|||Number
741233|NCT00478231|Primary|Number of Participants With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 and Grade 4 Laboratory Abnormalities|Grade 3 or severe events included those that interrupted participant's usual daily activity and traditionally required systemic drug therapy or other treatment. Grade 4 or very severe events included those that were unacceptable and intolerable or which were irreversible or caused the participant to be in imminent danger of death.|Baseline to 30 days post-week 96 or ET|The safety analysis set composed of all participants who received at least one dose of study medication. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively.||Participants|||Number
741234|NCT00478231|Primary|Number of Participants With Grade 3 and Grade 4 Adverse Events (AEs) and Serious Adverse Events (SAEs)|AEs: any untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was congenital anomaly. Grade 3: Events that interrupted participant’s usual daily activity and traditionally required systemic drug therapy or other treatment. Grade 4: Events which were unacceptable and intolerable or which were irreversible or caused participant to be in imminent danger of death.|Baseline to 30 days post-week 96 or early termination (ET)|The safety analysis set composed of all participants who received at least one dose of study medication.||Participants|||Number
741235|NCT00478244|Primary|Number of Patients With Detectable Collagen Type VII|Number of patients with epidermolysis bullosa who had collagen type VII. Type VII collagen defects cause recessive dystrophic epidermolysis bullosa (RDEB), a blistering skin disorder often accompanied by epidermal cancers.|Day 100 Post Transplant|||participants|||Number
741236|NCT00478244|Secondary|Number of Patients With Neutrophil Engraftment|Number of patients with an absolute neutrophil count >5 x 10^8 cells/liter for 3 consecutive days.|Day 42 Post Transplant|||participants|||Number
741237|NCT00478244|Secondary|Number of Patients With Resistance to Blister Formation|Resistance to Blister Formation demonstrated by response to negative pressure.|Month 1 through Month 24 Inclusive|Added blister formation testing later in study; only 2 patients had pre-transplant test.||participants|||Number
741238|NCT00478244|Secondary|Number of Patients With Donor Derived Cells in Skin|Number of patients who had donor skin chimerism - donor cells in the patient's epidermis (a state in bone marrow transplantation in which bone marrow and host cells exist compatibly without signs of graft-versus-host rejection disease).|Day 90 Post Transplant|||participants|||Number
741239|NCT00478244|Secondary|Overall Survival|Survival is defined as the number of patients that were alive post transplant.|1 year and 2 years Post Transplant|||participants|||Number
741240|NCT00478244|Secondary|Number of Patients With Chronic Graft-Versus-Host Disease (cGVHD)|Number of patients with cGVHD; a severe long-term complication created by infusion of donor cells into a foreign host.|Day 365 Post Transplant|||participants|||Number
741241|NCT00478244|Secondary|Number of Patients With Acute Graft-Versus-Host Disease (GVHD)|Number of patients with GVHD. Acute Graft-Versus-Host Disease is a severe short-term complication created by infusion of donor cells into a foreign host.|Day 100 Post Transplant|||participants|||Number
741242|NCT00478244|Secondary|Number of Patients With Platelet Engraftment|Number of patients with a platelet count >5 x 10^10 cells/liter for 3 consecutive measurements.|Day 180 Post Transplant|||participants|||Number
741243|NCT00478244|Secondary|Number of Patients With Transplant-Related Mortality|Number of patients who died due to complications of the transplant (includes all deaths without previous relapse or progression).|Day 180 Post Transplant|||participants|||Number
741244|NCT00478244|Secondary|Number of Patients With >70% Donor Chimerism|Number of patients with donor chimerism - percentage of donor cells in the patient via the peripheral blood or bone marrow.|Days 21, 100, 180, 365 and 730 Post Transplant|||participants|||Number
741245|NCT00478257|Primary|Fatigue|The Short Form of the Multidimensional Fatigue Symptom Inventory (MFSI-sf) was used to measure fatigue. The range of possible score for each subscale is 0 to 24, and the range for total score is −24 to 96, with a higher score indicating more severe fatigue, except for the Vigor subscale, where larger score indicates less fatigue.|four cycles of chemotherapy|All participants that were randomized and began the protocol were included in analyses.||units on a scale||Standard Error|Mean
741246|NCT00478556|Secondary|Bowel Opacification Score|The bowel opacification score was calculated by adding values for stomach, duodenum, jejunum and ileum for each patient. They were averaged across two doctors who read the studies. Scores can range from 0 (no opacification) to 3 (excellent) for each segment and from 0 to 12 for bowel opacification score.|Collected day of study|per protocol - all patients had usable data||units on a scale||Standard Deviation|Mean
742293|NCT00493012|Secondary|Change in Triglycerides From Baseline to 12 Months||baseline, 12 months|||mmol/l||Standard Deviation|Mean
741248|NCT00478569|Secondary|Treatment Compliance by Visit|"A participant was defined as compliant if the participant took the treatment as prescribed by the Physician, i.e. complied with the Physician’s advice and followed the treatment regimen prescribed. A participant whose dose frequency and treatment length were changed during treatment, e.g. in response to a raised serum calcium level, was regarded as fully compliant if the revised treatment regimen was adhered to.
Data on compliance were obtained at each visit and relate to the period since the previous recorded visit."|From enrollment to 3, 6, 12, 18, and 24 months|||participants|||Number
741249|NCT00478569|Secondary|Duration of Treatment|Duration of treatment was defined as the last known date that PTH(1-84) was taken minus the first date that PTH(1-84) was taken plus one. In the calculation of duration, no adjustment was made for the prescribed dose frequency or for periods of temporary discontinuation due to adverse drug reactions (ADRs) or temporary patient suspension of treatment.|24 months|Participants for whom data were available||months||Full Range|Mean
741250|NCT00478569|Secondary|Number of Participants Who Discontinued Before 3, 12, 18, and 24 Months of Treatment|A participant was defined as “permanently discontinued” if treatment with PTH(1-84) was not ongoing at the 6-month time point and at any future time points afterwards. A participant was defined as “temporarily discontinued” if treatment with PTH(1-84) was not ongoing at the time point but was then ongoing at a future time point. This was the case when a participant or investigator wanted to pause the treatment for a length of time (e.g. because of an adverse event or interruption). Therefore, a participant was defined as still “ongoing” during the trial if treatment with PTH(1-84) had not been permanently or temporarily discontinued at that time point. A participant was only defined as “missing” or “unknown” if they attended the relevant visit and there was no result or “unknown” was entered as the result. Results for months 3, 12, 18 and 24 are cumulative data up until that time point.|From enrollment to 3, 12, 18, and 24 months|All enrolled participants||participants|||Number
741251|NCT00478569|Primary|Number of Participants Who Discontinued Before 6 Months of Treatment|"A participant was defined as permanently discontinued if treatment with PTH(1-84) was not ongoing at the 6-month time point and at any future time points afterwards."|6 months|All enrolled participants||participants|||Number
741252|NCT00478608|Secondary|Number of Patients Experiencing Biopsy Confirmed Acute Rejection Through Month 12 After Transplantation|The diagnosis of acute rejection required a kidney biopsy. Biopsies were assessed using the Banff criteria, standardized diagnostic categories based on histological assessments (e.g., cell types and distributions).|12 months after transplantation|Patients who received at least one dosing of SRL after transplantation.||patients|||Number
741253|NCT00478608|Secondary|Patient and Graft Survival|Patient survival defined as patients living with or without a functioning graft. Graft survival defined as those patients who did not experience graft loss. Graft loss defined as physical loss (nephrectomy), functional loss (necessitating maintenance dialysis for >8 weeks), retransplant or death during the first 12 months after randomization.|12 months|Patients who received at least one dosing of SRL after transplantation.||patients|||Number
741254|NCT00478608|Secondary|Serum Creatinine|Serum creatinine is an indicator of kidney function. Creatinine is a substance formed from the metabolism of creatine, commonly found in blood, urine, and muscle tissue. It is removed from the blood by the kidneys and excreted in urine. An increased level of creatinine in the blood indicates decreased kidney function. Normal adult blood levels of creatinine are 0.5 to 1.1 mg/dL for females and 0.6 to 1.2 mg/dL for males; however, the normal values are age-dependent as elderly patients typically have smaller muscle mass.|Baseline, 6 and 12 months|Patients who received at least one dose of SRL after transplantation. Observed values||mg/dl||Standard Deviation|Mean
741255|NCT00478608|Secondary|Glomerular Filtration Rate (GFR) (Nankivell Method)|GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. GFR can be measured directly or estimated using established formulas. For this study, GFR was calculated using the Nankivell formula. A normal GFR is >90 mL/min, although children and older people usually have a lower GFR. Lower values indicate poorer kidney function. A GFR <15 is consistent with kidney failure.|6 and 12 months|Patients who received at least one dose of SRL after transplantation. Observed values||mL/min||Standard Deviation|Mean
741256|NCT00478608|Primary|Number of Patients Experiencing Biopsy Confirmed Acute Rejection Through Month 6 After Transplantation.|The diagnosis of acute rejection required a kidney biopsy. Biopsies were assessed using the Banff criteria, standardized diagnostic categories based on histological assessments (e.g., cell types and distributions).|6 months after transplantation|Patients who received at least one dosing of SRL after transplantation.||patients|||Number
741257|NCT00478647|Primary|Participants Who Experienced at Least One Adverse Event|"Safety was assessed throughout the study by assessments including adverse events, concomitant medication use, and vital signs. Additional safety assessments, including 12-lead ECGs, physical examinations, clinical laboratory tests and determination of the presence of anti-velaglucerase alfa antibodies.
Refer to Adverse event section for further details."|Week 53|Safety population included subjects who have received at least 1 full or partial dose of study drug.||participants|||Number
741258|NCT00478647|Secondary|Percent Change From Baseline to Week 51 in Normalized Spleen Volume|Spleen volume has been normalized for percentage (%) of body weight. Spleen size relative to body weight= (Spleen volume [cc]/Body weight [kg])*100|Week 51|ITT population. Four splenectomized participants were excluded.||Percent (%) change||90% Confidence Interval|Mean
741259|NCT00478647|Secondary|Percent Change From Baseline to Week 51 in Normalized Liver Volume|Liver volume has been normalized for percentage (%) of body weight. Liver size relative to body weight= (Liver volume [cc]/Body weight [kg])*100|Week 51|ITT population.||Percent (%) change||90% Confidence Interval|Mean
741260|NCT00478647|Secondary|Percent Change From Baseline to Week 53 in Platelet Count||Week 53|ITT population.||percent (%) change||90% Confidence Interval|Mean
741261|NCT00478647|Secondary|Change From Baseline to Week 53 in Hemoglobin Concentration||Week 53|ITT population.||g/dL||90% Confidence Interval|Mean
741272|NCT00478881|Secondary|Change From Baseline in Volume at First Desire to Void at 6 Weeks|Volume at first desire to void was recorded during urodynamic assessments. Missing data were imputed by last observation carried forward (LOCF).|baseline and up to 6 weeks of treatment LOCF|"Modified intent-to-treat (mITT): participants included in the safety sample (received at least one dose), randomized correctly according to the Urodynamic Adjudication Board (UDAB), having one valid baseline and one valid (UDAB) on treatment urodynamic measurement. The number is not identical to participants who completed the study."||mL||Standard Error|Least Squares Mean
741262|NCT00478673|Primary|Number of Participants Who Experienced a 12-Month Major Adverse Event (MAE)|12-month major adverse events (MAEs) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure (see 30-Day MAE above), and ipsilateral stroke events that occur within 31-365 days post-procedure.|12 Months|ITT Analysis: All enrolled subjects who experienced a 12-mo MAE and/or completed a follow-up evaluation >=335 days post-procedure were evaluable. Subjects who experienced more than one MAE within 12 months were counted in the number of subjects with each applicable event, but were only counted once in the number of subjects with overall 12-mo MAE.||Participants|||Number
741263|NCT00478673|Primary|Number of Participants Who Experienced a 30-Day Major Adverse Event (MAE)|30-day major adverse events (MAEs) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.|30 Days|ITT Analysis: All enrolled subjects who experienced a 30-day MAE and/or completed a follow-up evaluation >=23 days post-procedure were evaluable. Subjects who experienced more than one MAE within 30 days were counted in the number of subjects with each applicable event, but were only counted once in the number of subjects with overall 30-day MAE.||Participants|||Number
741264|NCT00478777|Secondary|Time to Partial Response Based on the European Group for Blood and Marrow Transplantation (EBMT) Myeloma Response Determination Criteria|Time to partial response is the time from randomization to a 50% decrease in serum paraprotein maintained for six weeks straight. This was determined by free light chain concentrations which were taken every two weeks during the treatment phase of the trial.|up to 827 days|Values for the free light chain concentrations were determined to be invalid.||Days||Standard Deviation|Mean
741265|NCT00478777|Secondary|Participants With Treatment-emergent Adverse Experiences (TEAEs)|"Counts of study participants who had treatment-emergent adverse events (TEAEs) defined as any reported AE that started on or after the first day of study drug dosing. A participant with multiple occurrences of an adverse event within a category is counted only once in that category.
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) was used by investigators to assess TEAEs. Severity scale ranges from 0 (none) to 5 (death). Grade 3=severe AE; Grade 4=life threatening or disabling AE; Grade 5=death."|up to 8 months|Safety population||participants|||Number
741266|NCT00478777|Secondary|Participant's Best Overall Response Based on the European Group for Blood and Marrow Transplantation (EBMT) Myeloma Response Criteria|"Best overall response was calculated as the best assessment from all cycles (including treatment discontinuation visit) and follow-up. The response rate was summarized as complete response (CR), partial response (PR), stable disease (SD), progression (PD), response not evaluable, and derived categories (PR+CR) and (PR+CR+SD).
CR is negative immunofixation on both serum and urine maintained for 6 weeks straight. PR is a 50% decrease in serum paraprotein maintained for 6 weeks straight. SD is serum paraprotein values within 25% of baseline."|Up to 827 days|Full analysis set||participants|||Number
741267|NCT00478777|Primary|Kaplan Meier Estimate for Time to Disease Progression|"Time to disease progression (TTP) was based on the European Group for Blood and Marrow Transplantation (EBMT) myeloma response determination criteria developed by Bladé (Bladé, 1998). TTP is a Kaplan Meier estimate of the time from randomization to the first documentation of progressive disease.
Progressive disease based on increasing monoclonal paraprotein levels require a confirmatory value one week apart. Disease progression can also be based on bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia."|up to 827 days|Full analysis dataset||days||95% Confidence Interval|Median
741268|NCT00478881|Secondary|Change From Baseline in the Total Score of the Overactive Bladder Questionnaire (OAB-q) at 6 Weeks|The OAB-q is a validated, self-administered questionnaire that quantifies bladder symptoms and quality of life. It comprises 33 items (6-point scale for each item). The total score ranges from 33 (minimum symptoms) to 198 (maximum symptoms). On each item, participants provide their rating over the past 4 weeks. Missing data were imputed by LOCF.|baseline and up to 6 weeks of treatment LOCF|"Intent-to-treat (ITT) population: all randomized participants with at least one study drug medication were to be included provided they had a baseline measurement (if scheduled) and a follow-up measurement in any clinical variable. The number is not identical to participants who completed."||scores on a scale||Standard Error|Least Squares Mean
741269|NCT00478881|Secondary|Change From Baseline in Peak Urinary Flow at 6 Weeks in Men Aged 50 Years and Older|Peak urinary flow (Qmax) was measured using urodynamic assessments (voiding / flow cystometry) for up to 6 weeks. Missing data were imputed by last observation carried forward (LOCF).|baseline and up to 6 weeks of treatment LOCF|mITT: Participants who received at least one dose, randomized correctly according to Urodynamic Adjudication Board (UDAB), having one valid baseline and one valid (UDAB) on treatment urodynamic measurement. Qmax is based on men predominantly aged 50 years and older but includes a few males who had Qmax collected even if younger than 50 years.||milliliter per second (mL/s)||Standard Error|Least Squares Mean
741270|NCT00478881|Secondary|Change From Baseline in Average Number of Daily Involuntary Discharges of Urine at 6 Weeks|The average number of daily involuntary discharges of urine was derived from the number of discharges reported by the participants in a 7 day micturition diary. Missing data were imputed by last observation carried forward.|baseline and up to 6 weeks of treatment LOCF|"Intent-to-treat (ITT) population: all randomized participants with at least one study drug medication were to be included provided they had a baseline measurement (if scheduled) and a follow-up measurement in any clinical variable. The number is not identical to participants who completed."||involuntary discharges per day||Standard Error|Least Squares Mean
741271|NCT00478881|Secondary|Change From Baseline in Average Number of Urgencies Per Day at 6 Weeks|The average number of urgencies was derived from the number of urgencies reported by the participants in a 7 day micturition diary. Missing data were imputed by last observation carried forward.|baseline and up to 6 weeks of treatment LOCF|"Intent-to-treat (ITT) population: all randomized participants with at least one study drug medication were to be included provided they had a baseline measurement (if scheduled) and a follow-up measurement in any clinical variable. The number is not identical to participants who completed."||urgencies per day||Standard Error|Least Squares Mean
741322|NCT00479466|Primary|Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG)||Week 12|All participants who received at least one dose of study therapy, had a baseline measurement, and had at least one post-randomization measurement.||mg/dL||95% Confidence Interval|Least Squares Mean
742294|NCT00493012|Secondary|Change in Parathyroid Hormone From Baseline to 12 Months||baseline, 12 months|||pmol/l||Standard Deviation|Mean
741273|NCT00478881|Secondary|Change From Baseline in Maximum Cystometric Bladder Capacity at 6 Weeks|Maximum cystometric bladder capacity was defined as the volume at which either significant leakage or discomfort/pain occurred. Missing data were imputed by last observation carried forward (LOCF).|baseline and up to 6 weeks of treatment LOCF|"Modified intent-to-treat (mITT): participants included in the safety sample (received at least one dose), randomized correctly according to the Urodynamic Adjudication Board (UDAB), having one valid baseline and one valid (UDAB) on treatment urodynamic measurement. The number is not identical to participants who completed the study."||mL||Standard Error|Least Squares Mean
741274|NCT00478881|Secondary|Change From Baseline in Volume at First Detectable Leakage at 6 Weeks|First detectable leakage was determined by means of cystometry as an obligatory urodynamic measure. Missing data was imputed by last observation carried forward (LOCF).|baseline and up to 6 weeks of treatment LOCF|"Modified intent-to-treat (mITT): participants included in the safety sample (received at least one dose), randomized correctly according to the Urodynamic Adjudication Board (UDAB), having one valid baseline and one valid (UDAB) on treatment urodynamic measurement. The number is not identical to participants who completed the study."||mL||Standard Error|Least Squares Mean
741275|NCT00478881|Secondary|Change From Baseline in H2O Detrusor Pressure at First Contraction at 6 Weeks|Detrusor pressure was measured by means of urodynamic assessment (cystometry) for up to 6 weeks. Missing data were imputed by last observation carried forward (LOCF).|baseline and up to 6 weeks of treatment LOCF|"Modified intent-to-treat (mITT) population: participants included in the safety sample (received at least one dose), randomized correctly according to the Urodynamic Adjudication Board (UDAB), having one valid baseline and one valid (UDAB) on treatment urodynamic measurement. The number is not identical to participants who completed the study."||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
741276|NCT00478881|Primary|Change From Baseline in Average Number of Daily Micturitions at 6 Weeks|Change from baseline in the number of daily micturitions (bladder voidings), as reported in the participant diaries for up to 6 weeks. Missing data were imputed with last observation carried forward (LOCF).|baseline and up to 6 weeks of treatment LOCF|"Intent-to-treat (ITT) population: all randomized participants with at least one study drug medication were to be included provided they had a baseline measurement (if scheduled) and a follow-up measurement in any clinical variable. The number is not identical to participants who completed."||micturitions per day||Standard Error|Least Squares Mean
741277|NCT00478881|Primary|Change From Baseline in Bladder Volume at First Detrusor Contraction at 6 Weeks|Bladder volume was measure by means of urodynamic assessments (cystometry) for up to 6 weeks. Missing data were imputed with last observation carried forward (LOCF).|baseline and up to 6 weeks of treatment Last Observation Carried Forward (LOCF)|"Modified intention-to-treat (mITT): participants included in the safety sample (received at least one dose), randomized correctly according to the Urodynamic Adjudication Board (UDAB), having one valid baseline and one valid (UDAB) on treatment urodynamic measurement. The number is not identical to participants who completed the study."||mL||Standard Error|Least Squares Mean
741278|NCT00479037|Secondary|Percentage Change in the Bone Resorption Marker C-Telopeptide Cross-links (CTX) From Baseline to End of Trial|"CTX is a marker of bone resorption, which is a degradation product of bone collagen.
Bone marker measurements were done by blood analysis."|Baseline and 24 weeks of treatment|ITT analysis. Number of participants analyzed = number of participants with data available.||percent change||Standard Deviation|Mean
741279|NCT00479037|Primary|Percentage Change in the Bone Formation Marker Bone Specific Alkaline Phosphatase (BSAP) From Baseline to End of Trial|"BSAP is a marker of bone formation that reflects the cellular activity of osteoblasts.
Bone marker measurements were done by blood analysis."|Baseline and 24 weeks of treatment|ITT analysis. Number of participants analyzed = number of participants with data available.||percent change||Standard Deviation|Mean
741280|NCT00479037|Primary|Percentage Change in the Bone Formation Marker N-terminal Propeptides of Human Procollagen Type I (P1NP) From Baseline to End of Trial|"P1NP is a bone formation marker that is derived from the amino-terminal propeptides of type I collagen and is considered a quantitative measure of newly formed type I collagen.
Bone marker measurements were done by blood analysis."|Baseline and 24 weeks of treatment|ITT (Intention to Treat) analysis. Number of participants analyzed = number of participants with data available.||percent change||Standard Deviation|Mean
741281|NCT00479089|Secondary|Median Progression Free Survival From Trial Enrollment for Overall Study|Progressive disease was defined as at least a 25% increase from baseline, of the sum of the products of the two greatest dimensions of representative measurable lesions. Increasing severity in symptoms due to progressive tumor was also counted as progression even if they were not accompanied by an objective indicator on radiographic imaging. The development of any new measurable lesions was considered evidence of progressive cancer as well.|From trial enrollment to disease progression or death, up to five years|Analysis by intent to treat population with all participants treated included.||Months||Full Range|Median
741282|NCT00479089|Secondary|Median Overall Survival|Overall survival was summarized using the Kaplan-Meier estimation.|Baseline till participant death or end of follow-up period, assessed every 4 weeks, up to 5 years.|Analysis by intent to treat population with all participants treated included.||Months||Full Range|Median
741283|NCT00479089|Primary|Number of Participants Free From Progression 9 Months From Start of Consolidation Therapy|The proportion of participants’ progression free at 9 months compared between treatments using chi-square. Progressive disease was defined as at least a 25% increase from baseline, of the sum of the products of the two greatest dimensions of representative measurable lesions. Increasing severity in symptoms due to progressive tumor was also counted as progression even if they were not accompanied by an objective indicator on radiographic imaging. The development of any new measurable lesions was considered evidence of progressive cancer as well.|Assessment at 9 Months of therapy|In order to test the trial hypotheses for the two cohorts progression at nine months, a sample size of 45 participants for each arm was required. Accrual was not met to assess the outcome hypotheses thus no participant analysis available.|||||
741284|NCT00479154|Primary|Change in Restless Legs Syndrome Rating Scale|Primary outcome measure will be the mean change from baseline in RLS scale at week 2 following placebo/BTX injections. Scoring criteria are: Mild (score 1-10); Moderate (score 11-20); Severe (score 21-30); Very severe (score 31-40).|Week 2 and Week 4 for each intervention (vs. baseline)|||RLS Rating Score||Standard Deviation|Mean
742295|NCT00493012|Secondary|Change in Calcitriol From Baseline to 12 Months||baseline, 12 months|||pmol/l||Standard Deviation|Mean
741285|NCT00479232|Other Pre-specified|Objective Response Rate in Participants Treated With Vorinostat + Decitabine With Intermediate-high Risk Myelodysplastic Syndrome (MDS) or Untreated Acute Myelogenous Leukemia (AML)|Objective Response Rate was measured in participants with intermediate-high risk MDS or untreated AML who were treated with vorinostat and decitabine either on a concurrent or sequential regimen. The Objective response was defined as any confirmed complete remission or any confirmed partial remission for AML participants and complete remission, confirmed partial remission or confirmed hematologic improvement for MDS participants.|Approximately 6 months|||percentage of participants|||Number
741286|NCT00479232|Other Pre-specified|Objective Response Rate in Participants Treated With Vorinostat + Decitabine With Refractory or Relapse Acute Myelogenous Leukemia (AML)|Objective Response Rate was measured in participants with refractory or relapse AML (acute myelogenous leukemia) in combination with Decitabine who were treated with vorinostat and decitabine on either a concurrent or sequential regimen. The Objective response was defined as any confirmed complete remission or any confirmed partial remission for AML participants and complete remission, confirmed partial remission or confirmed hematologic improvement for Myelodysplastic Syndrome (MDS) participants.|Approximately 6 months|||percentage of participants|||Number
741287|NCT00479232|Primary|Number of Participants Experiencing Dose Limiting Toxicity (DLT) Events|Participants who received at least one dose of vorinostat in combination with decitabine intravenous (IV) at a dose of 20 mg/m^2 daily for 5 days along with oral vorinostat 400 mg once daily for 7 to 14 days in a 28-day cycle concurrently or sequentially, were evaluated to determine the maximum tolerable dose (MTD) determined by the number of participants experiencing dose limiting toxicity (DLT) events defined as any Grade 3 or 4 non-hematological toxicity (reported adverse event) and/or myelosuppression lasting >42 days.|Day 1 to 28 of Cycle 1|||participants|||Number
741288|NCT00479258|Secondary|7 Point Home Glucose||12 months||||||
741289|NCT00479258|Secondary|Hypoglycemic Event Rates;||12 months||||||
741290|NCT00479258|Secondary|Change From Baseline in Body Weight (kg), Height (cm), and Body Mass Index (BMI; kg/m2) and z Score (%);Dose of Insulin;||12 months||||||
741291|NCT00479258|Secondary|Change From Baseline in Insulin Antibodies (microU/mL);||12 months||||||
741292|NCT00479258|Secondary|Proportion of Subjects Achieving ADA Age Appropriate Guidelines for HbA1c||12 months||||||
741293|NCT00479258|Secondary|Slope for Other PFT Parameters;||12 months||||||
741294|NCT00479258|Secondary|Change From Baseline in FVC||12 months||||||
741295|NCT00479258|Secondary|Treatment Preferences.||12 months||||||
741296|NCT00479258|Secondary|Slope From Baseline to Week 52 and Slope From Week 12 to Week 52 for FEV1 and FVC as a Percent of Predicted;||12 months||||||
741297|NCT00479258|Secondary|Change From Baseline in Other PFT Parameters||12 months||||||
741298|NCT00479258|Primary|To Assess Pulmonary Safety and Glycemic Control of Exubera Over a 12 Month Controlled Period|No subjects were dosed therefore no data collected.|12 months|No subjects were dosed therefore no participants for analysis.||no data|||Number
741299|NCT00479336|Secondary|Abdominal Circumference|Change in abdominal circumference from baseline (LOCF)|Baseline, Day 7 or at the discontied of treatment|Full Analysis Set; LOCF||cm||Standard Deviation|Mean
741300|NCT00479336|Primary|Body Weight (Amount of Change)|Changes in body wight from baseline at the final timepoint (LOCF). A linear regression model using changes in body weight from baseline at the final timepoint as the criterion variable and dose as the explanatory variable was fitted to the dataset.|Baseline, Day 7 or at the discontied of treatment|Full Analysis Set; LOCF||Kg||Standard Deviation|Mean
741301|NCT00479388|Secondary|Percent Change From Baseline in Triglycerides at Week 12||Baseline and 12 Weeks|Full Analysis Set With at Least one Post-Titration Visit Measurement||Percent||95% Confidence Interval|Median
741302|NCT00479388|Secondary|Percent Change From Baseline in High Density Lipoprotein Cholesterol at Week 12||Baseline and 12 Weeks|Full Analysis Set||Percent||95% Confidence Interval|Least Squares Mean
741303|NCT00479388|Primary|Percent Change From Baseline in Low Density Lipoprotein Cholesterol at Week 12||Baseline and 12 Weeks|Full Analysis Set||Percent||95% Confidence Interval|Least Squares Mean
741304|NCT00479401|Secondary|Clinical Relevant Abnormal Findings in Vital Signs and Physical Examination as Reported in Adverse Events||baseline and after 33 weeks of treatment|Treated set (TS)||participants|||Number
741305|NCT00479401|Secondary|Possible Clinically Significant Abnormal Laboratory Parameters|The significant abnormality of values was based on standard criteria defined in appendix 16.1.10, LISTING 4 Criteria for clinically significant abnormalities based on normalized laboratory values.|baseline and after 33 weeks of treatment|Treated Set Labs (TSLabs), all patients in TS with a clinical laboratory measurements at baseline and at the last visit.||participants|||Number
741306|NCT00479401|Secondary|Number of Patients With Treatment Emergent Abnormal Behaviour as Indicated by the Modified Minnesota Impulsive Disorders Interview (mMIDI Questionnaire)|mMIDI is a semi-structured clinical interview to assess pathological gambling (12 questions, positive screen if patient answers 'yes' to question 1 and to at least 5 of the rest of the questions), compulsive buying (9 questions from 1a to 4c, positive screen if the patient answers 'yes' to 1a, 2a, 3a, and 4a) and compulsive sexual behaviour (4 questions, positive screen if patient answers 'yes' to question 1,2,3, or 4).|from trial start on to any time before final assessment of the patient, up to 33 weeks|Treated Set (TS), all randomized patients, who were dispensed study medication and documented to have taken at least 1 dose of study medication.||patients|||Number
741307|NCT00479401|Secondary|Patients Who Started to Use L-Dopa Rescue Medication|L-dopa could be introduced as rescue medication based upon the clinical judgement of the investigator. descriptive on the Full Analysis Set (FAS) population|from trial start on to any time before final assessment of the patient, up to 33 weeks|Full Analysis Set, all randomized patients, received at least one dose of study drug and provided any post baseline efficacy assessment||patients|||Number
741308|NCT00479401|Secondary|Change From Baseline in European Quality of Life Visual Analog Scale|European Quality of Life Visual Analog Scale (EQ-5D VAS) is a 20 centimeter vertical analog scale assessing the patient's general health status with scores ranging from 0 (worst imaginable health) to 100 (perfect health). A positive change in the scale indicates improvement in health status.|after 33 weeks treatment|Full Analysis Set, all randomized patients, received at least one dose of study drug and provided any post baseline efficacy assessment||units on a scale||95% Confidence Interval|Mean
746153|NCT00520767|Secondary|Overall Survival||Day 1 of Each Cycle and every 12 weeks after last treatment cycle||||||
741309|NCT00479401|Secondary|Change From Baseline in Parkinson's Disease Quality of Life Questionnaire Total Score|"The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health which patients consider to be adversely affected by the disease. Higher scores are consistently associated with more severe symptoms of the disease such as tremor and stiffness, while lower scores indicate a better perceived health status. The 8 domains include:
mobility (e.g. fear of falling when walking): 10 items
activities of daily living (e.g. difficulty cutting food): 6 items
emotional well-being (e.g. feelings of isolation): 6 items
stigma (e.g. social embarrassment): 4 items
social support: 3 items
cognition: 4 items
communication: 3 items
bodily discomfort: 3 items.
A total score is calculated by summing the responses to the 39 individual items and the total ranges from 0 (no problem at all) to 156 (maximum level of problem). A negative change in the total score indicates improvement."|after 33 weeks treatment|Full Analysis Set, all randomized patients, received at least one dose of study drug and provided any post baseline efficacy assessment||units on a scale||95% Confidence Interval|Mean
741310|NCT00479401|Secondary|Parkinson's Disease Sleep Scale (PDSS)|PDSS is a self-rated instrument addressing 15 commonly reported symptoms associated with sleep disturbance on 15 visual analogue scales (VAS: 0 to 10 cm) each ranging from worst score ('awful or always' at the left extremity to the best score ('excellent or never' at the right extremity) An increase in the score means improvement. Worst possible score 0, best score 150)|after 33 weeks treatment|Full Analysis Set, all randomized patients, received at least one dose of study drug and provided any post baseline efficacy assessment||units on a scale||95% Confidence Interval|Mean
741311|NCT00479401|Secondary|Likert Scale for Pain Related to PD|Patient assessed 11 units on a scale from 'no pain' to 'unbearable pain'. Decrease of the score means improvement|after 33 weeks treatment|Full Analysis Set, all randomized patients, received at least one dose of study drug and provided any post baseline efficacy assessment||units on a scale||95% Confidence Interval|Mean
741312|NCT00479401|Secondary|Beck's Depression Inventory Version I A|The Beck's Depression Inventory (BDI) is a 21-item self-rating scale that was originally designed as an instrument to assess the intensity of depressive symptoms (sadness, pessimism, sense of failure, dissatisfaction, guilt, expectation of punishment, dislike of self, self-accusation, suicidal ideation, episodes of crying, irritability, social withdrawal, indecisiveness, changes in body image, retardation, insomnia, fatigability, loss of appetite and weight, somatic preoccupation, low level of energy). Each item is scored from 0 (absent) to 3 (severe). The patients select the score which best describes their status in the last 7 days. Since its introduction in 1961, its use has been extended (also to PD patients) and today it is used also as a screening instrument as well as an outcome measure in depression treatment trials. The total score sums the 21 individual items yielding a score that can range from zero (minimal depression) to 63 (severe depression).|after 33 weeks treatment|Full Analysis Set, all randomized patients, received at least one dose of study drug and provided any post baseline efficacy assessment||units on a scale||95% Confidence Interval|Mean
741313|NCT00479401|Secondary|UPDRS Part III Total Score|UPDRS III is the result of a motor examination with the scores 0-108. A decrease in the scores means improvement|after 33 weeks treatment|Full Analysis Set, all randomized patients, received at least one dose of study drug and provided any post baseline efficacy assessment||units on a scale||95% Confidence Interval|Mean
741314|NCT00479401|Secondary|UPDRS Part II Total Score|UPDRS II evaluates activities of daily living in a score 0-52. Decrease of the score means improvement|after 33 weeks treatment|Full Analysis Set, all randomized patients, received at least one dose of study drug and provided any post baseline efficacy assessment||units on a scale||95% Confidence Interval|Mean
741315|NCT00479401|Secondary|UPDRS Part I Change From Baseline|UPDRS I evaluates mentation behaviour and mood with a total score of 0-16. Decrease in the scores means improvement|baseline and after 33 weeks treatment|Full Analysis Set with (LOCF), all randomized patients, received at least one dose of study drug and provided any post baseline efficacy assessment||units on a scale||Inter-Quartile Range|Median
741316|NCT00479401|Secondary|UPDRS II+III Responder Rate (at Least 20% Improvement)|Responders are defined as at least 20% decrease in the UPDRS II+III score. UPDRS II+III ranges 0-160 scores from best to worse.|after 33 weeks treatment|Full Analysis Set, all randomized patients, received at least one dose of study drug and provided any post baseline efficacy assessment||percentage of responders|||Number
741317|NCT00479401|Secondary|Percentage of Responders on the Patients Global Impressions of Improvement (PGI-I) Scale|Patient rated evaluation of the PD symptoms on a rating scale of 7 steps, 1 meaning very much better to 7 meaning very much worse. Responders are the patients with 'much better' and 'very much better' on the score.|after 18 weeks of treatment compared to baseline|Full Analysis Set 1, all randomized patients, received at least one dose of study drug and provided any post baseline efficacy assessment and completed 18 weeks of treatment or discontinued prematurely at the interim cut off date Apr 2008||Percentage of Participants|||Number
741318|NCT00479401|Secondary|Percentage of Responders on the Clinical Global Impressions of Improvement (CGI-I) Scale|Clinicians evaluation in a rating scale of 7 steps, 1 meaning very much improved to 7 meaning very much worse. Responders are the patients with 'much improved' and 'very much improved' on the scale|after 18 weeks of treatment compared to baseline|Full Analysis Set 1, all randomized patients, received at least one dose of study drug and provided any post baseline efficacy assessment and completed 18 weeks of treatment or discontinued prematurely at the interim cut off date Apr 2008||Percentage of Participants|||Number
741319|NCT00479401|Primary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts II+III Total Score|Activities of daily living are scored from 0-52 in UPDRS II, result of motor examination scored 0-108 in UPDRS III. A decrease in the score means improvement.|baseline and after 33 weeks treatment|Full Analysis Set, all randomized patients, received at least one dose of study drug and provided any post baseline efficacy assessment||units on a scale||95% Confidence Interval|Least Squares Mean
741320|NCT00479466|Secondary|Change From Baseline to Week 12 in 2-Hour Post Prandial Glucose (PPG)||Week 12|All participants who received at least one dose of study therapy, had a baseline measurement, and had at least one post-randomization measurement.||mg/dL||95% Confidence Interval|Least Squares Mean
741321|NCT00479466|Secondary|Change From Baseline to Week 12 in Hemoglobin A1c (HbA1c)||Week 12|All participants who received at least one dose of study therapy, had a baseline measurement, and had at least one post-randomization measurement.||mg/dL||95% Confidence Interval|Least Squares Mean
742296|NCT00493012|Secondary|Change in 25-hydroxyvitamin D From Baseline to 12 Months||baseline, 12 months|||nmol/l||Standard Deviation|Mean
741324|NCT00479557|Secondary|GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104|The LLOQ was 50 U/mL and when the assay result was below LLOQ (50 U/mL), 25 U/mL was imputed for IgM.|Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104|The immunogenicity population included all randomized participants with documented injection of at least one dose of study drug and at least one immunogenicity data point collected.||U/mL||95% Confidence Interval|Geometric Mean
741325|NCT00479557|Secondary|Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104|The lower limit of quantification (LLOQ) was 100 U/mL and when the assay result was below LLOQ (100 U/mL), 50 U/mL was imputed for IgG.|Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104|The immunogenicity population included all randomized participants with documented injection of at least one dose of study drug and at least one immunogenicity data point collected.||U/mL||95% Confidence Interval|Geometric Mean
741326|NCT00479557|Primary|Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs)|An AE was any untoward, undesired, or unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study drug or in a sponsor’s clinical study. The event did not need to be causally related to the study drug or the clinical studies. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|approximately 110 weeks, including a 6-week screening period, 52 weeks of dosing and 54 weeks for follow-up after the last dose.|The safety population included all randomized participants with documented use of at least one dose of study drug.||percentage of participants|||Number
741327|NCT00479674|Secondary|to Determine if SPARC Expression in Breast Tumors Predicts Progression-free Survival (PFS)||18 months|Study plan stipulated that tissue samples would not be assessed for quantitatively if no difference in SPARC expression was observed between tumor and non-tumor cells was observed qualitatively.|||||
741328|NCT00479674|Secondary|to Determine if Apolipoprotein Alleles (Apo-E) Correlate With Treatment-related Neuropathy||18 months|Samples were collected, but analysis was not performed as there was inadequate funding to support the testing and analysis of samples.|||||
741329|NCT00479674|Secondary|To Evaluate Sequential Plasma Samples for Presence of Selected Angiogenic Markers||18 months|Analysis of samples was not performed, as there was inadequate funding to support the testing and analysis of the samples.|||||
741330|NCT00479674|Secondary|Median Proportion Progression-free as Estimated by Kaplan-Meier Methods|PFS was defined as time from trial enrollment to disease progression or death, whichever occurred first.|5 years|One subject lost to follow up and not included in analysis.||months||95% Confidence Interval|Median
741331|NCT00479674|Primary|"Best Clinical Response Expressed as Percentage of Participants Treated With Combination Regimen of Weekly Abraxane® and Carboplatin Plus Biweekly Bevacizumab to Treat Women With Stage IV or Inoperable Stage III Triple Negative Metastatic Breast Cancer."|Best clinical response is based on RECIST criteria, the proportion in each response category along with the exact binomial confidence intervals are estimated. Toxicity summaries are also provided.|5 years|2 subjects withdrew and were not assessed for response||percentage of participants||95% Confidence Interval|Number
741332|NCT00479713|Other Pre-specified|Percent Change From Baseline in High-sensitivity C (Hs-C) Reactive Protein|Percent change from baseline in hs-C reactive protein at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100.|Baseline and 6 weeks|Full Analysis Set (FAS): The FAS population includes all randomized participants who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value.||percent change from baseline||95% Confidence Interval|Median
741333|NCT00479713|Other Pre-specified|Percent Change From Baseline in Apolipoprotein B|Percent change from baseline in apolipoprotein (Apo) B at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100.|Baseline and 6 weeks|Full Analysis Set (FAS): The FAS population includes all randomized participants who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value.||percent change from baseline||95% Confidence Interval|Least Squares Mean
741334|NCT00479713|Other Pre-specified|Percent Change From Baseline in Total Cholesterol/High Density Lipoprotein-Cholesterol (HDL-C) Ratio|Percent change from baseline in total cholesterol/HDL-C ratio at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100.|Baseline and 6 weeks|Full Analysis Set (FAS): The FAS population includes all randomized participants who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value.||percent change from baseline||95% Confidence Interval|Least Squares Mean
741335|NCT00479713|Other Pre-specified|Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C)/High Density Lipoprotein-Cholesterol (HDL-C) Ratio|Percent change from baseline in LDL-C/HDL-C ratio at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100.|Baseline and 6 weeks|Full Analysis Set (FAS): The FAS population includes all randomized participants who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value.||percent change from baseline||95% Confidence Interval|Least Squares Mean
741336|NCT00479713|Other Pre-specified|Percent Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C)|Percent change from baseline in non HDL-C at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100.|Baseline and 6 weeks|Full Analysis Set (FAS): The FAS population includes all randomized participants who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value.||percent change from baseline||95% Confidence Interval|Least Squares Mean
741377|NCT00473265|Secondary|Percent Change in BMD From Baseline to 24 Months by DXA|Bone Mineral Density (BMD) as measured by Dual-energy X-ray absorptiometry (DXA).|baseline versus 24 months|Only the first 30 participants who completed 24 months of the study were analyzed||percentage of change to BMD||Standard Deviation|Mean
741337|NCT00479713|Other Pre-specified|Percent Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C)|Percent change from baseline in HDL-C at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100.|Baseline and 6 weeks|Full Analysis Set (FAS): The FAS population includes all randomized participants who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value.||percent change from baseline||95% Confidence Interval|Least Squares Mean
741338|NCT00479713|Other Pre-specified|Percent Change From Baseline in Triglycerides.|Percent change from baseline in triglycerides at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100.|Baseline and 6 weeks|Full Analysis Set (FAS): The FAS population includes all randomized participants who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value.||percent change from baseline||95% Confidence Interval|Median
741339|NCT00479713|Other Pre-specified|Percent Change From Baseline in Total Cholesterol|Percent change from baseline in total cholesterol at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100.|Baseline and 6 weeks|Full Analysis Set (FAS): The FAS population includes all randomized participants who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value.||percent change from baseline||95% Confidence Interval|Least Squares Mean
741340|NCT00479713|Secondary|The Percentage of Participants Achieving Designated Low Density Lipoprotein-Cholesterol (LDL-C) Levels After 6 Weeks of Treatment|"The percentage of participants who achieved a target LDL-C goal of < 100 mg/dL, of <70 mg/dL, and of <77 mg/dL at study endpoint after six weeks of treatment.
The numerator is the number of participants in a treatment group who achieved a target LDL-C goal and the denominator is the total number of participants within that treatment group."|after 6 weeks of treatment|Full Analysis Set (FAS)||Percent of participant population|||Number
741341|NCT00479713|Primary|Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) at Study Endpoint After Six Weeks of Treatment|Percent Change in LDL-C at study endpoint after six weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100.|Baseline and 6 weeks|Full Analysis Set (FAS): The FAS population includes all randomized participants who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value.||percent change from baseline||95% Confidence Interval|Least Squares Mean
741342|NCT00479765|Primary|Occurence of Dose-limiting Toxicities (DLTs)|any evidence or sign of a dose-limiting toxicity after administration to determine the maximum tolerated dose (MTD)|8 weeks|||dose limiting toxicities|||Number
741343|NCT00479856|Secondary|Number of Participants With the Indicated Serious Adverse Events and Adverse Events|Qualitative and quantitative toxicities associated with the combination of capecitabine, docetaxel, or nab-paclitaxel and lapatinib were measured. Data are presented as serious adverse events (SAEs) and adverse events (AEs). See the SAE/AE section of the results record for data.|Baseline through End of Treatment, or discontinuation of study therapy (approximately 95 weeks); from the first dose of lapatinib until 5 days after the last dose of lapatinib|||participants|||Number
741344|NCT00479856|Secondary|Progression-free Survival|The time from the start of treatment until the earliest date of disease progression or death due to any cause was measured.|from start of treatment and every 6 weeks (wks) until Wk 12, then every 12 wks thereafter through the end of treatment (~95 weeks); dependent on when participant discontinued study therapy due to disease progression, death, adverse event, or other reason)|Due to the low incidence of relapse and hence the difficulty in identifying eligible participants, the study was terminated with only 9 out of the 45 planned participants enrolled. As there were too few participants to derive statistically meaningful conclusions, only the primary endpoint of overall response rate was evaluated.||weeks||95% Confidence Interval|Median
741345|NCT00479856|Secondary|Time to Response (TTR)|TTR is defined as the time from the start of treatment until the first documented evidence of PR or CR (whichever status was recorded first). When tumor response was confirmed at a repeat assessment, the TTR was taken to be the first time that the response was observed.|start of treatment until first documented evidence of CR or PR (approximately 95 weeks)|Due to the low incidence of relapse and hence the difficulty in identifying eligible participants, the study was terminated with only 9 out of the 45 planned participants enrolled. As there were too few participants to derive statistically meaningful conclusions, only the primary endpoint was evaluated.||weeks||95% Confidence Interval|Median
741346|NCT00479856|Secondary|Duration of Response|For the subset of participants with a confirmed CR or PR, duration of response was measured as the time from first documented evidence of CR or PR until the first documented sign of disease progression or death.|time from first documented evidence of CR or PR until the first documented sign of disease progression or death (approximately 95 weeks)|Due to the low incidence of relapse and hence the difficulty in identifying eligible participants, the study was terminated with only 9 out of the 45 planned participants enrolled. As there were too few participants to derive statistically meaningful conclusions, only the primary endpoint was evaluated.||weeks||95% Confidence Interval|Median
741347|NCT00479856|Secondary|Clinical Benefit (CB)|CB is defined as the percentage of participants (par.) with either a confirmed CR or PR or stable disease (SD) for at least 24 weeks. SD is defined as small changes that do not meet criteria for CR, PR, or Progressive Disease (defined as at least a 20% increase in the sum of the longest diameter of target lesions).|from start of treatment and every 6 weeks (wks) until Wk 12, then every 12 wks thereafter through the end of treatment (~95 weeks; dependent on when participant discontinued study therapy due to disease progression, death, adverse event, or other reason)|Due to the low incidence of relapse and hence the difficulty in identifying eligible par., the study was terminated with only 9 out of the 45 planned par. enrolled. As there were too few par. to derive statistically meaningful conclusions, only the primary endpoint was evaluated.||percentage of participants|||Number
741378|NCT00473265|Primary|Requirements for Calcium Supplementation|Serum and urinary calcium levels maintained by change in requirements for calcium supplementation|2 years|Only the first 30 participants to complete 24 months in the study were analyzed||grams per day of calcium supplementation||Standard Deviation|Mean
741553|NCT00474123|Primary|Oxidized Low-Density Lipoprotein Cholesterol|Serum samples were stored at -70°C and were determined simultaneously by ELISA in order to avoid variation of assay conditions. Commercial ELISA assays detecting oxLDL (Mercodia, USA) were applied.|Change from baseline at 6 weeks|per protocol||Percentage||Standard Deviation|Mean
741348|NCT00479856|Primary|Overall Tumor Response|Overall tumor response is defined as the percentage of participants with a confirmed complete or partial tumor response per Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is defined as the disappearance of all target lesions. CR could only be declared if all target and non-target lesions had disappeared. Partial response (PR) is defined as a decrease of 30% or greater in the sum of the longest diameter of target lesions.|from start of treatment and every 6 weeks (wks) until Wk 12, then every 12 wks thereafter through the end of treatment (~95 wks; dependent on when participant discontinued study therapy due to disease progression, death, adverse event, of other reason)|All Treated Subjects (ATS) Population: all participants who received at least one dose of study treatment||percentage of participants|||Number
741349|NCT00479882|Secondary|Percentage Change From Baseline in HDL-C at Week 4|Blood samples taken at baseline (Day1 of Period I) and after 4 weeks of treatment to determine the HDL-C levels. The change from baseline after 4 weeks of treatment was recorded.|Baseline (Day1 of Period I) and Week 4|Participants that completed the study and had respective endpoint data available at baseline and end of each treatment period. End of period value was defined as measurements collected on the same date as the corresponding end of period visit date. Results were reported by dose of study drug taken and not by randomly assigned sequence.||Percentage Change||95% Confidence Interval|Least Squares Mean
741350|NCT00479882|Secondary|Percentage Change From Baseline in LDL-C at Week 4|Blood samples taken at baseline (Day1 of Period I) and after 4 weeks of treatment to determine the LDL-C levels. The change from baseline after 4 weeks of treatment was recorded.|Baseline (Day1 of Period I) and Week 4|Participants that completed the study and had respective endpoint data available at baseline and end of each treatment period. End of period value was defined as measurements collected on the same date as the corresponding end of period visit date. Results were reported by dose of study drug taken and not by randomly assigned sequence.||Percentage Change||95% Confidence Interval|Least Squares Mean
741351|NCT00479882|Secondary|Percentage of Participants Who Experience at Least 1 Hepatitis-related Non-serious Clinical AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. Non-serious Hepatitis-related AEs were identified by a collective review using the following pre-specified set of preferred terms: cholestasis, hepatic necrosis, hepatocellular damage, cytolytic hepatitis, hepatitis, hepatomegaly, jaundice, hepatic failure, hepatitis cholestatic, jaundice cholestatic, hepatitis fulminant, hyperbilirubinaemia, jaundice hepatocellular, ocular icterus, yellow skin, hepatic function abnormal, acute hepatic failure, subacute hepatic failure, hepatitis acute, hepatitis toxic, hepatotoxicity, and mixed hepatocellular-cholestatic injury.|up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)|All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).||Percentage of Participants|||Number
741352|NCT00479882|Secondary|Percentage of Participants Who Were Discontinued From the Study Due to a Laboratory AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test. Participants who were discontinued from the study due to a laboratory AE were recorded.|up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)|All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).||Percentage of Participants|||Number
741353|NCT00479882|Secondary|Percentage of Participants Who Were Discontinued From the Study Due to a Clinical AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. A clinical AE was an AE reported as a result of a clinical examination or reported by the participant. Participants who were discontinued from the study due to a clinical AE were recorded.|up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)|All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined, where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover). Excludes 6 participants who had an AE that began during the placebo run-in.||Percentage of Participants|||Number
741354|NCT00479882|Secondary|Percentage of Participants Who Experience at Least 1 Laboratory AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test|up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)|All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).||Percentage of Participants|||Number
741379|NCT00473330|Secondary|Mean Change From Month 36 in Central Foveal Thickness in the Study Eye at Month 48|Central foveal thickness was assessed in optical coherence tomographic images by the central reading center. A decrease in foveal thickness suggests a reduction in macular edema. A negative change score indicates improvement.|Month 36 to Month 48|Intent-to-treat population: All randomized patients, whether or not treatment was received. The Month 48 data are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.||µm||Standard Deviation|Mean
742297|NCT00493012|Secondary|Change in Fat Mass From Baseline to 12 Months||baseline, 12 months|||kg||Standard Deviation|Mean
741355|NCT00479882|Secondary|Percentage of Participants Who Experience at Least 1 Clinical Adverse Event (AE)|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. A clinical AE was an AE reported as a result of a clinical examination or reported by the participant.|up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)|All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).||Percentage of Participants|||Number
741356|NCT00479882|Secondary|Percentage of Participants With a Confirmed Adjudicated Cardiovascular Event|Select serious adverse cardiovascular events and all-cause mortality that occurred during the treatment phase of the study were adjudicated by an expert committee external to the sponsor. Those events confirmed by the committee as cardiovascular events were recorded|up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)|All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).||Percentage of Participants|||Number
741357|NCT00479882|Secondary|Percentage of Participants With Worsening of the Pre-existing Conditions of Diabetes in Participants With Diabetes at Baseline|Participants with diabetes at baseline and who experienced a worsening of the diabetes identified through adverse event reports using a pre-defined set of terms and/or increasing dose/adding a new anti-diabetic medication.|up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)|All participants with diabetes at baseline and who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).||Percentage of Participants|||Number
741358|NCT00479882|Secondary|Percentage of Participants With New Diagnosis of Diabetes|Participants who with newly diagnosed of diabetes were recorded. A participant was classified as having new onset diabetes if they experienced an adverse Event (AE) related to a diagnosis of diabetes (based on a pre-defined set of Medical Dictionary for Regulatory Activities [MedDRA] terms), or if they started taking an anti-diabetic medication during the course of the study. The MedDRA terms were as follows: diabetes mellitus, diabetes mellitus insulin-dependent, diabetes mellitus non-insulin dependent, insulin-requiring type II diabetes mellitus, insulin resistant diabetes, diabetes with hyperosmolarity, latent autoimmune diabetes in adults.|up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)|All participants without diabetes at baseline and who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).||Percentage of Participants|||Number
741359|NCT00479882|Secondary|Percentage of Participants With New Diagnosis of Impaired Fasting Blood Glucose|Participants had fasting glucose levels assessed during Period I (4 weeks ) throughout each 8 week treatment period (20 weeks total). Participants who had the new diagnosis of impaired fasting blood glucose were recorded. A pre-defined set of MedDRA terms was used to identify participants whose glycemic status became ‘impaired’ during the course of treatment (from clinical adverse experience reports). The MedDRA terms were as follows: blood glucose increased, blood glucose abnormal, glucose tolerance decreased, glucose tolerance test abnormal, carbohydrate tolerance decreased, glucose tolerance impaired, hyperglycaemia, impaired fasting glucose, impaired insulin secretion, metabolic syndrome, insulin resistance, insulin resistance syndrome.|up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)|All participants who had normal fasting blood glucose levels at baseline and who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).||Percentage of Participants|||Number
741360|NCT00479882|Secondary|Percentage of Participants With CK >=10 x ULN With Muscle Symptoms - Drug Related|Participants had CK levels assessed during Period I (4 weeks ) throughout each 8 week treatment period (20 weeks total). Participants who had an assessment of CK that was 10 x ULN or greater and had associated muscle symptoms present within +/- 7 days that were reported as at least possibly related to study drug were recorded. The ULNs for males and females were 207 U/L and 169 U/L, respectively.|up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)|All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).||Percentage of Participants|||Number
741361|NCT00479882|Secondary|Percentage of Participants With CK >=10 x ULN With Muscle Symptoms|Participants had CK levels assessed during Period I (4 weeks ) throughout each 8 week treatment period (20 weeks total). Participants who had an assessment of CK that was 10 x ULN or greater and had associated muscle symptoms present within +/- 7 days were recorded. The ULNs for males and females were 207 U/L and 169 U/L, respectively.|up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)|All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).||Percentage of Participants|||Number
741362|NCT00479882|Secondary|Percentage of Participants With Creatine Kinase (CK) >=10 x ULN|Participants had CK levels assessed during Period I (4 weeks ) throughout each 8 week treatment period (20 weeks total). Participants who had an assessment of CK that was 10 x ULN or greater were recorded. The ULNs for males and females were 207 U/L and 169 U/L, respectively.|up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)|All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).||Percentage of Participants|||Number
741583|NCT00480324|Secondary|Number of Subjects Reporting Solicited Symptoms|Solicited symptoms assessed include cough, diarrhoea, fever, irritability, loss of appetite and vomiting.|During the 8-day follow-up period after each dose|The analysis was performed on the Total Vaccinated cohort.||subjects|||Number
741363|NCT00479882|Secondary|Percentage of Participants With Consecutive Elevations in Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) of >=3 x Upper Limit of Normal (ULN)|Participants had AST and ALT levels assessed during Period I (4 weeks ) throughout each 8 week treatment period (20 weeks total). Participants who had an assessment of either AST or ALT that was 3 x ULN or greater were recorded. The AST ULNs for males and females were 43 U/L and 36 U/L, respectively. The ALT ULNs for males and females were 40 U/L and 33 U/L, respectively.|up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)|All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).||Percentage of Participants|||Number
741364|NCT00479882|Secondary|Percentage Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)|Blood samples taken at baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment during each period to determine the HDL-C levels. The change from baseline after 8 weeks of treatment was recorded.|Baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment during each period (Week 12 for Period II and Week 20 for Period III)|Participants who completed the study and had respective endpoint data available at baseline and end of each treatment period. End of period value was defined as measurements collected on the same date as the corresponding end of period visit date. Results were reported by dose of study drug taken and not by randomly assigned sequence.||Percentage Change||95% Confidence Interval|Least Squares Mean
741365|NCT00479882|Primary|Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)|Blood samples taken at baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment during each period to determine the LDL-C levels. The change from baseline after 8 weeks of treatment was recorded.|Baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment during each period (Week 12 for Period II and Week 20 for Period III)|Participants who completed the study and had respective endpoint data available at baseline and end of each treatment period. End of period value was defined as measurements collected on the same date as the corresponding end of period visit date. Results were reported by dose of study drug taken and not by randomly assigned sequence.||Percentage Change||95% Confidence Interval|Least Squares Mean
741366|NCT00473083|Primary|Overall Incidence of Grade 3 Rash|"The overall incidence of grade 3 erlotinib-induced rash among the three treatment arms.
For overall incidence of rash a binary variable will be designed. Data will be summarized with percentages by treatment group."|From onset of rash until resolution, up to 4 weeks following progression, on average of 1 year|||percentage of participants|||Number
741367|NCT00473083|Secondary|Time to First Presentation of Rash||Up to onset of rash while on study treatment|Subjects with maximum severity of rash of grade 1, 2a, 2b and 3||days||Standard Deviation|Mean
741368|NCT00473083|Secondary|Duration of Treatment||Up to one year|||months||95% Confidence Interval|Median
741369|NCT00473083|Secondary|Overall Survival||Until death|||months||95% Confidence Interval|Median
741370|NCT00473083|Secondary|Severity of Rash Caused by Erlotinib|The maximum severity of rash per subject will be summarized by treatment group. The summary will include only subjects who indicated any occurrence of rash.|Onset until resolution, up to 4 weeks following progression, on average of 1 year|Arm 1 (n=42), Arm 2 (n=42), Arm 3, (n=41)||percentage of participants|||Number
741371|NCT00473083|Primary|Time Duration From Onset of Rash Until Resolution|"To investigate if the rash caused by erlotinib is self-limiting.
A time variable will be defined to identify the duration from onset of rash until resolution. Resolution will be defined as resolution to severity Grade 1 for patients with rash of maximum severity grade >1 and resolution to Grade 0 for patients with maximum rash severity = 1. For patients where resolution is not observed the time considered will be the maximum time from onset of rash until end of the study.
The analyses will be performed using the following two sub-populations: subjects with maximum severity of rash of Grade 1, 2a and 2b will constitute one sub-population and Grade 3 will be considered the second sub-population.
The comparisons will be performed primarily for Group 1 vs. Group 3 and Group 2 vs. Group 3 and secondly for Group 1 vs. Group 2."|From onset of rash until resolution, up to 4 weeks following progression, an average of 1 year|"Patients With Maximum Severity of Rash Grade 1, 2b: Arm 1 (n=36), Arm 2 (n=38), Arm 3 (n=27)
Patients With Maximum Severity of Rash Grade 3: Arm 1 (n=6), Arm 2 (n=4), Arm 3 (n=14)"||days||Inter-Quartile Range|Median
741372|NCT00473083|Primary|Overall Incidence of Rash|"The overall incidence of any grade of erlotinib-induced rash among the three treatment arms.
For overall incidence of rash a binary variable will be designed. Data will be summarized with percentages by treatment group."|From onset of rash until resolution, up to 4 weeks following progression, an average of 1 year|||percentage of participants|||Number
741373|NCT00473265|Secondary|Mineralizing Surface|Mineralizing surface done on histomorphometric assessment of percutaneous iliac crest bone biopsy. Mineralizing surface measures how much of bone is getting new mineral put on it. The structure and microscopic organization of a small piece of biopsied pelvic bone was analyzed.|baseline versus one year|Only 14 subjects had paird bone biopsies obtained at baseline and after 12 months of PTH(1-84) treatment.||percentage of surface||Standard Deviation|Mean
741374|NCT00473265|Secondary|Cortical Porosity|Cortical porosity done on histomorphometric assessment of percutaneous iliac crest bone biopsy. Cortical Porosity measures how many tiny holes there are in the solid bone section. The structure and microscopic organization of a small piece of biopsied pelvic bone was analyzed.|baseline versus two years|Only 16 subjects had paired bone biopsies obtained at baseline and after 24 months of PTH(1-84) treatment.||percentage of porosity||Standard Deviation|Mean
741375|NCT00473265|Secondary|Trabecular Number|trabecular number done on histomorphometric assessment of percutaneous iliac crest bone biopsy. Trabecular number is the number of individual pieces of the spongy bone section. The structure and microscopic organization of a small piece of biopsied pelvic bone was analyzed.|baseline versus two years|Only 16 subjects had paired bone biopsies obtained at baseline and after 24 months of PTH(1-84) treatment.||mm^-1||Standard Deviation|Mean
741376|NCT00473265|Secondary|Trabecular Width|Trabecular width was obtained from histomorphometric assessment of percutaneous iliac crest bone biopsy. Trabecular width is the thickness of individual pieces of the spongy bone section. The structure and microscopic organization of a small piece of biopsied pelvic bone was analyzed.|baseline versus two years|Only 16 subjects had paired bone biopsies obtained at baseline and after 24 months of PTH(1-84) treatment.||micrometers||Standard Deviation|Mean
741380|NCT00473330|Secondary|Percentage of Patients Who Lost < 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score in the Study Eye From Month 36 at Month 48|BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision.|Month 36 to Month 48|Intent-to-treat population: All randomized patients, whether or not treatment was received. The Month 48 data are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.||Percentage of participants||95% Confidence Interval|Number
741381|NCT00473330|Secondary|Mean Change From Month 36 in Best Corrected Visual Acuity (BCVA) Score in the Study Eye at Month 48|BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision. A positive change score indicates improvement.|Month 36 to Month 48|Intent-to-treat population: All randomized patients, whether or not treatment was received. The Month 48 data are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.||Letters||Standard Deviation|Mean
741382|NCT00473330|Secondary|Percentage of Patients Who Gained ≥ 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline at Months 36 and 48|BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision.|Baseline to Month 48|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed up to Month 36 using the last observation carried forward method. The Month 48 outcome measures are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.||Percentage of patients||95% Confidence Interval|Number
741383|NCT00473330|Secondary|Mean Number of Macular Laser Treatments From Baseline Through Months 24 and 36|The need for macular laser treatment was evaluated by the masked (evaluating) physician. Macular laser was administered per protocol-specified objective and subjective criteria starting at Month 3.|Baseline to Month 36|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed using the last observation carried forward method.||Treatments||Standard Deviation|Mean
741384|NCT00473330|Secondary|Percentage of Patients With Resolution of Leakage at Month 24|Resolution of leakage was defined as total area of fluorescein leakage in the central, inner, and outer subfields of the 0 Disc Area. Leakage was assessed in fluorescein angiographic images by the central reading center.|Baseline to Month 24|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed using the last observation carried forward method.||Percentage of patients||95% Confidence Interval|Number
741385|NCT00473330|Secondary|Percentage of Patients With a ≥ 3-step Worsening From Baseline in the Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale Score for Eyes at Months 24 and 36|The severity of diabetic retinopathy was graded on a 10-point scale by the central reading center by comparing patient fundus photographic images with a set of standard images. 1=diabetic retinopathy (DR) severity level 10, 12 (DR absent), 2=DR severity level 14A-14C, 14Z, 15, 20 (DR questionable, microaneurysms only), 3=DR severity level 35A-35F (mild non-proliferative [NP]DR), 4=DR severity level 43A, 43B (moderate NPDR), 5=DR severity level 47A-47D (moderately severe NPDR), 6=DR severity level 53A-53E (severe NPDR), 7=DR severity level 60, 61A, 61B (mild proliferative [P]DR), 8=DR severity level 65A-65C (moderate PDR), 9=DR severity level 71A-71D (high-risk PDR), 10=DR severity level 90 (cannot grade). A lower score indicates less severe diabetic retinopathy.|Baseline to Month 36|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed using the last observation carried forward method.||Percentage of patients||95% Confidence Interval|Number
741386|NCT00473330|Secondary|Mean Change From Baseline in Central Foveal Thickness at Months 24, 36, and 48|Central foveal thickness was assessed in optical coherence tomographic images by the central reading center. A decrease in foveal thickness suggests a reduction in macular edema. A negative change score indicates improvement.|Baseline to Month 48|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed up to Month 36 using the last observation carried forward method. The Month 48 outcome measures are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.||µm||Standard Deviation|Mean
741387|NCT00473330|Secondary|Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at Months 24 and 36 in Patients With Focal Edema at Baseline|BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision. A positive change score indicates improvement.|Baseline to Month 36|Subgroup of the intent-to-treat population: All randomized patients with focal edema at baseline, whether or not treatment was received. Missing data were imputed using the last observation carried forward method.||Letters||Standard Deviation|Mean
741388|NCT00473330|Secondary|Percentage of Patients Who Lost < 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline at Months 24, 36, and 48|BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision.|Baseline to Month 48|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed up to Month 36 using the last observation carried forward method. The Month 48 outcome measures are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.||Percentage of patients||95% Confidence Interval|Number
741399|NCT00473382|Secondary|Mean Change From Baseline in Central Foveal Thickness at Months 24, 36, and 48|Central foveal thickness was assessed in optical coherence tomographic images by the central reading center. A decrease in foveal thickness suggests a reduction in macular edema. A negative change score indicates improvement.|Baseline to Month 48|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed up to Month 36 using the last observation carried forward method. The Month 48 outcome measures are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.||µm||Standard Deviation|Mean
741389|NCT00473330|Secondary|Percentage of Patients With a Visual Acuity (VA) Snellen Equivalent of 20/40 or Better at Months 24, 36, and 48|VA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart starting at a test distance of 4 meters. An increase in the number of lines read correctly by the patient in the ETDRS chart indicates an improvement of vision. The Snellen equivalent of 20/40 or better is 69 or more letters correctly read in the EDTRS chart.|Months 24, 36, and 48|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed up to Month 36 using the last observation carried forward method. The Month 48 outcome measures are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.||Percentage of patients||95% Confidence Interval|Number
741390|NCT00473330|Secondary|Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at Months 24, 36, and 48|BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision. A positive change score indicates improvement.|Baseline to Month 48|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed up to Month 36 using the last observation carried forward method. The Month 48 outcome measures are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.||Letters||Standard Deviation|Mean
741391|NCT00473330|Primary|Percentage of Patients Who Gained ≥ 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline at Month 24|BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision.|Baseline to Month 24|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed using the last observation carried forward.||Percentage of patients||95% Confidence Interval|Number
741392|NCT00473382|Secondary|Mean Change From Month 36 in Central Foveal Thickness in the Study Eye at Month 48|Central foveal thickness was assessed in optical coherence tomographic images by the central reading center. A decrease in foveal thickness suggests a reduction in macular edema. A negative change score indicates improvement.|Month 36 to Month 48|Intent-to-treat population: All randomized patients, whether or not treatment was received. The Month 48 data are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.||µm||Standard Deviation|Mean
741393|NCT00473382|Secondary|Percentage of Patients Who Lost < 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score in the Study Eye From Month 36 at Month 48|BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision.|Month 36 to Month 48|Intent-to-treat population: All randomized patients, whether or not treatment was received. The Month 48 data are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.||Percentage of patients||95% Confidence Interval|Number
741394|NCT00473382|Secondary|Mean Change From Month 36 in Best Corrected Visual Acuity (BCVA) Score in the Study Eye at Month 48|BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision. A positive change score indicates improvement.|Month 36 to Month 48|Intent-to-treat population: All randomized patients, whether or not treatment was received. The Month 48 data are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.||Letters||Standard Deviation|Mean
741395|NCT00473382|Secondary|Percentage of Patients Who Gained ≥ 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline at Months 36 and 48|BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision.|Baseline to Month 48|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed up to Month 36 using the last observation carried forward method. The Month 48 outcome measures are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.||Percentage of patients||95% Confidence Interval|Number
741396|NCT00473382|Secondary|Mean Number of Macular Laser Treatments From Baseline Through Months 24 and 36|The need for macular laser treatment was evaluated by the masked (evaluating) physician. Macular laser was administered per protocol-specified objective and subjective criteria starting at Month 3.|Baseline to Month 36|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed using the last observation carried forward method.||Treatments||Standard Deviation|Mean
741397|NCT00473382|Secondary|Percentage of Patients With Resolution of Leakage at Month 24|Resolution of leakage was defined as total area of fluorescein leakage in the central, inner, and outer subfields of the 0 Disc Area. Leakage was assessed in fluorescein angiographic images by the central reading center.|Baseline to Month 24|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed using the last observation carried forward method.||Percentage of patients||95% Confidence Interval|Number
741398|NCT00473382|Secondary|Percentage of Patients With a ≥ 3-step Worsening From Baseline in the Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale Score for Eyes at Months 24 and 36|The severity of diabetic retinopathy was graded on a 10-point scale by the central reading center by comparing patient fundus photographic images with a set of standard images. 1=diabetic retinopathy (DR) severity level 10, 12 (DR absent), 2=DR severity level 14A-14C, 14Z, 15, 20 (DR questionable, microaneurysms only), 3=DR severity level 35A-35F (mild non-proliferative [NP]DR), 4=DR severity level 43A, 43B (moderate NPDR), 5=DR severity level 47A-47D (moderately severe NPDR), 6=DR severity level 53A-53E (severe NPDR), 7=DR severity level 60, 61A, 61B (mild proliferative [P]DR), 8=DR severity level 65A-65C (moderate PDR), 9=DR severity level 71A-71D (high-risk PDR), 10=DR severity level 90 (cannot grade). A lower score indicates less severe diabetic retinopathy.|Baseline to Month 36|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed using the last observation carried forward method.||Percentage of patients||95% Confidence Interval|Number
741400|NCT00473382|Secondary|Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at Months 24 and 36 in Patients With Focal Edema at Baseline|BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision. A positive change score indicates improvement.|Baseline to Month 36|Subgroup of the intent-to-treat population: All randomized patients with focal edema at baseline, whether or not treatment was received. Missing data were imputed using the last observation carried forward method.||Letters||Standard Deviation|Mean
741401|NCT00473382|Secondary|Percentage of Patients Who Lost < 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline at Months 24, 36, and 48|BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision.|Baseline to Month 48|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed up to Month 36 using the last observation carried forward method. The Month 48 outcome measures are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.||Percentage of patients||95% Confidence Interval|Number
741402|NCT00473382|Secondary|Percentage of Patients With a Visual Acuity (VA) Snellen Equivalent of 20/40 or Better at Months 24, 36, and 48|VA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart starting at a test distance of 4 meters. An increase in the number of lines read correctly by the patient in the ETDRS chart indicates an improvement of vision. The Snellen equivalent of 20/40 or better is 69 or more letters correctly read in the EDTRS chart.|Months 24, 36, and 48|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed up to Month 36 using the last observation carried forward method. The Month 48 outcome measures are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.||Percentage of patients||95% Confidence Interval|Number
741403|NCT00473382|Secondary|Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at Months 24, 36, and 48|BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision. A positive change score indicates improvement.|Baseline to Month 48|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed up to Month 36 using the last observation carried forward method. The Month 48 outcome measures are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.||Letters||Standard Deviation|Mean
741404|NCT00473382|Primary|Percentage of Patients Who Gained ≥ 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline at Month 24|BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision.|Baseline to Month 24|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed using the last observation carried forward.||Percentage of patients||95% Confidence Interval|Number
741405|NCT00473434|Secondary|The Length of Hospitalizations Throughout the Study||52 weeks|Participants who were hospitalized and had evaluable data at each measurement time point||days||Standard Deviation|Mean
741406|NCT00473434|Secondary|The Number of Hospitalizations Throughout the Study|This outcome measure is intended to document all hospitalizations that occurred throughout the study.|52 Weeks|All participants with evaluable data at each measurement time point||events|||Number
741407|NCT00473434|Secondary|The Percentage of Participants Presenting Clinical Deterioration Throughout the Study|This Outcome Measure is intended to document only the hospitalizations associated with clinical deterioration, ie, when the patient needs to be hospitalized due to exacerbation of psychotic symptoms.|52 Weeks|All participants with evaluable data at each measurement time point||percentage of participants|||Number
741408|NCT00473434|Secondary|The Global Assessment of Functioning (GAF) Throughout the Study|The GAF is a 100-point tool rating overall psychological, social and occupational functioning of adults. The higher score range (91-100) refers to a superior functioning in a wide range of activities, and absence of symptoms. The lower score range (1-10) refers to persistent danger of severely hurting self or others; or persistent inability to maintain minimum personal hygiene; or serious suicidal act with clear expectation of death.|52 Weeks|All participants with evaluable data at each measurement time point||scores on a scale||Standard Deviation|Mean
741409|NCT00473434|Secondary|The Clinical Global Impression of Severity (CGI-S) Throughout the Study|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a patient. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill patients."|52 weeks|All participants with evaluable data at each measurement time point||scores on a scale||Standard Deviation|Mean
741410|NCT00473434|Primary|The Median Overall Average Daily-prescribed Dose of Paliperidone Extended Release (ER) From Week 0 to Week 12||Week 0 to Week 12|Intent-To-Treat (ITT) population||mg||95% Confidence Interval|Median
741411|NCT00473434|Primary|The Mean Overall Average Daily-prescribed Dose of Paliperidone Extended Release (ER) From Week 0 to Week 12||Week 0 to Week 12|Intent-To-Treat (ITT) population||mg||Standard Deviation|Mean
741412|NCT00473434|Primary|The Median Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 57 to Day 84||Day 57 to Day 84|Intent-To-Treat (ITT) population, excluding participants no longer participating in the study at Day 57||mg||95% Confidence Interval|Median
741413|NCT00473434|Primary|The Mean Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 57 to Day 84||Day 57 to Day 84|Intent-To-Treat (ITT) population, excluding participants no longer participating in the study at Day 57||mg||Standard Deviation|Mean
741414|NCT00473434|Primary|The Median Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 1 to Day 84||Day 1 to Day 84|Intent-To-Treat (ITT) population||mg||95% Confidence Interval|Median
741415|NCT00473434|Primary|The Mean Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 1 to Day 84||Day 1 to Day 84|Intent-To-Treat (ITT) population||mg||Standard Deviation|Mean
741416|NCT00473512|Other Pre-specified|Time to Last Quantifiable Plasma Concentration (Tlast) of Abiraterone|The actual sampling time of last measurable (non-below the limit of quantification [BQL]) analyte concentration. The analyte concentration associated with Tlast is referred to as Clast.|Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was given|Data was not statistically summarized but reported in individual participant listing as per planned analysis.|||||
741417|NCT00473512|Other Pre-specified|Plasma Decay Half-Life (t1/2) of Abiraterone|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was given|Included all participants who enrolled into the study regardless of the amount of the trial medication received. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.||hour||Standard Deviation|Mean
741418|NCT00473512|Other Pre-specified|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Abiraterone|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was given|Included all participants who enrolled into the study regardless of the amount of the trial medication received. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.||hours*nmol/L||Standard Deviation|Mean
741419|NCT00473512|Other Pre-specified|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Abiraterone|Area under the plasma concentration time-curve from time zero to the last quantifiable concentration (AUClast).|Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was given|Included all participants who enrolled into the study regardless of the amount of the trial medication received. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.||hours*nmol/L||Standard Deviation|Mean
741420|NCT00473512|Other Pre-specified|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Abiraterone|The Tmax is defined as actual sampling time to reach maximum observed plasma concentration. The analyte concentration associated with Tmax is referred to as Cmax.|Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was given|Included all participants who enrolled into the study regardless of the amount of the trial medication received. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.||hours||Standard Deviation|Mean
741421|NCT00473512|Other Pre-specified|Maximum Observed Plasma Concentration (Cmax) of Abiraterone|The Cmax is defined as maximum observed analyte concentration.|Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was given|Included all participants who enrolled into the study regardless of the amount of the trial medication received. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.||nmol/L||Standard Deviation|Mean
741422|NCT00473512|Other Pre-specified|Mean Plasma Concentration of Abiraterone||Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was given|Data was not statistically summarized but reported in individual participant listing as per planned analysis.|||||
741423|NCT00473512|Other Pre-specified|Number of Participants With Change From Baseline in Biochemical Bone Markers||Baseline, Cycle 2, 4, 8, 12|Data was reported in individual participant listings but not summarized due to statistical constraints.|||||
741424|NCT00473512|Other Pre-specified|Time to Prostate Cancer Pain Progression|The time from start of study treatment to the development/worsening of pain due to prostate cancer requiring one or more of the following treatments: 1- Opioid therapy (therapy with morphine like medicines for 10 out of 14 consecutive days); 2- Glucocorticoid therapy; 3- Initiation of >= 5 mg of prednisolone for 10 out of 14 consecutive days; 4- Radionuclide therapy; 5- Radiation therapy (x-ray or cobalt treatment); 6- Chemotherapy (treatment of disease by chemical agents). Participants who do not experience prostate cancer pain were censored on their last day on study. Time to prostate cancer pain progression was measured by Kaplan-Meier method.|Baseline up to 12 cycles|Median time was not reached as data was not matured at the time of the analysis, hence no data could be reported.|||||
741425|NCT00473512|Other Pre-specified|Serum Blood Levels of Testosterone Precursors|Concentration of Cortisol, Aldosterone, Corticosterone, 11-Deoxycortisol, Deoxycorticosterone and Dehydroepiandrostenedione Sulphate (DHEA-S) in blood was measured in nanogram per deciliter (ng/dL).|Baseline, Cycle 2 (within 3 days prior to Day 29)|All participants who were enrolled in the study and received 1000 mg abiraterone acetate therapy with or without dexamethasone (including participants who received 1000 mg AA monotherapy). Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and 'n' signifies participants evaluable at specified time point.||ng/dL||Full Range|Median
741426|NCT00473512|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to 30 days after the last dose of study medication|Included all participants who received any amount of the study medication.||participants|||Number
741427|NCT00473512|Other Pre-specified|Serum Blood Levels of Testosterone|Concentration of testosterone in blood was measured in nanogram per deciliter (ng/dL).|Baseline, Cycle 2 (within 3 days prior to Day 29)|All participants who were enrolled in the study and received 1000 mg abiraterone acetate therapy with or without dexamethasone (including participants who received 1000 mg AA monotherapy). Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and 'n' signifies participants evaluable at specified time point.||ng/dL||Full Range|Median
741428|NCT00473512|Secondary|Overall Survival|Overall survival was the duration from enrollment to death. For participants who are alive, overall survival was censored at the last contact.|Baseline up to end of study (1160 days)|Data was not analyzed due to high number of participants censored for survival.|||||
741429|NCT00473512|Secondary|Time to Disease Progression|Disease progression was defined as greater than 25 percent increase in sum of longest diameter of target lesions compared to baseline.|Baseline up to end of study (1160 days)|Data was not analyzed because at the time to progression, participants also received dexamethasone treatment, making it impractical to accurately define disease progression.|||||
741430|NCT00473512|Secondary|Duration of Objective Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST)|Number of participants with objective response based on assessment of confirmed CR or confirmed PR according to RECIST. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as greater than or equal to 30 percent decrease in sum of the LD of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study greater than or equal to 4 weeks after initial documentation of response.|Baseline up to end of study (1160 days)|Duration of response was not analyzed as majority of participants with objective tumor response were lost to follow-up.|||||
741431|NCT00473512|Secondary|Duration of Prostate Specific Antigen (PSA) Response|Duration of PSA response in participants on abiraterone acetate therapy was measured as the duration between PSA 50 percent decline date and PSA progression date as defined by the PSAWG criteria.|Baseline up to end of study (1160 days)|All participants who were enrolled in the study and received 1000 milligram abiraterone acetate therapy with or without dexamethasone (including participants who received 1000 mg AA monotherapy). Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.||Days||Full Range|Median
741432|NCT00473512|Secondary|Number of Participants With Objective Tumor Response|Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as greater than or equal to 30 percent decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study greater than or equal to 4 weeks after initial documentation of response.|Baseline up to end of study (1160 days)|All participants who were enrolled in the study and received 1000 milligram abiraterone acetate therapy with or without dexamethasone (including participants who received 1000 mg AA monotherapy). Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.||Participants|||Number
741433|NCT00473512|Primary|Number of Participants With Confirmed Prostate Specific Antigen (PSA) Response at Week 12|The PSA response was measured according to PSA working group (PSAWG) criteria. All participants achieving a fall in PSA of greater than 50 percent from baseline, which has been confirmed by a second measurement at least 4 weeks after initial documentation, fulfill criteria for confirmed PSA response.|Baseline, Week 12|All participants who were enrolled in the study and received 1000 milligram abiraterone acetate therapy with or without dexamethasone (including participants who received 1000 mg AA monotherapy). Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.||Participants|||Number
741434|NCT00473564|Secondary|Assessment of Patients Safety by Evaluating the Number of Participants Who Experienced Known Complications From the Use of the da Vinci® Robotic System During Surgery, Experienced a Need for Conversion to Open Surgery or Required Additional Surgery.|Assessment of patient safety evaluating the number of participants who experienced known complications from the use of the da Vinci® Robotic System during surgery, who experienced a need for conversion to open surgery during the procedure, or who required additional surgery for re-excision of the lesion due to positive margins|3 - 24 months postoperatively|Participants who successfully underwent transoral robotic-assisted surgery using the da Vinci® Robotic System||participants|||Number
741435|NCT00473564|Primary|Number of Participants With Adequate Exposure and Access to Oropharyngeal and Hypopharyngeal Head and Neck Lesions|Number of participants with adequate exposure and access for use of the da Vinci® Robotic System in oropharyngeal and hypopharyngeal head and neck lesions|Intraoperatively average of 2 hours|||participants|||Number
741436|NCT00473590|Secondary|Number of Participants With Selected Adverse Events (AEs)|Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0. All serious adverse events are listed in the Adverse Event Reporting section.|Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination (up to 122 weeks).|Safety population: all patients who were randomized and received any amount of study treatment. Two patients who randomized to the BORT + P arm received at least 1 dose of bevacizumab and were analyzed as bevacizumab-treated patients. Therefore, the safety analysis included 50 patients in the BORT + P arm and 50 patients in the BORT + BV arm.||Participants|||Number
741437|NCT00473590|Primary|Progression-free Survival (PFS)|Progression-free survival (PFS) was defined as the time from randomization to disease progression or death on study from any cause within 30 days of the last response assessment. Disease progression was determined by the investigator using the International Myeloma Working Group's (IMWG) uniform response criteria. Median PFS was estimated using Kaplan-Meier methodology. For patients who were alive at the time of the analysis and whose disease had not yet progressed, PFS was censored at the time of the last response assessment.|From randomization to disease progression or death on study (up to 116 weeks).|Randomized Patients||months||95% Confidence Interval|Median
741438|NCT00473590|Secondary|Overall Survival (OS)|Overall survival was defined as the duration of time from randomization until death from any cause. All deaths were included, whether they occurred on study treatment or following treatment discontinuation. Overall survival was estimated using Kaplan-Meier. For patients who had not died, overall survival was censored at the date that the patient was last known to be alive.|From randomization until death from any cause, up until the end of study (clinical cut-off; up to 116 weeks).|Randomized Patients||Months||95% Confidence Interval|Median
741439|NCT00473590|Secondary|Duration of Response|Duration of response was defined as the time from the initial response to disease progression or death on study. Disease progression was determined by the investigator using the IMWG’s uniform response criteria and defined as an increase of ≥25% from best response in: Serum M-protein and/or Urine M-protein and/or Marrow plasma cells; or new or increased plasmacytomas or bone lesions; or hypercalcemia due to myeloma. Duration of response was estimated using Kaplan-Meier. For patients who had not progressed or died, duration of response was censored at the date of the last response assessment.|From randomization to the end of study (clinical cut-off; up to 116 weeks).|Randomized Patients with an overall response||Months||95% Confidence Interval|Median
741440|NCT00473590|Secondary|Percentage of Participants With an Overall Response|Overall response was defined as a stringent complete response, complete response, very good partial response, or partial response (sCR, CR, VGPR, and PR) determined on two consecutive assessments ≤ 6 weeks apart and before the initiation of any new anti-tumor therapy, as assessed by the investigator using the IMWG's uniform response criteria. Patients without a post-baseline response assessment or who died prior to their first scheduled response assessment were considered non-responders.|From randomization to the end of study (clinical cut-off; up to 116 weeks).|Randomized Patients||Percentage of Participants||95% Confidence Interval|Number
741441|NCT00473590|Secondary|Number of Participants With an Overall Response|Overall response was defined as a stringent complete response, complete response, very good partial response, or partial response (sCR, CR, VGPR, and PR, respectively) determined on two consecutive assessments ≤ 6 weeks apart and before the initiation of any new anti-tumor therapy, as assessed by the investigator using the International Myeloma Working Group’s (IMWG's) uniform response criteria. Patients without a post-baseline response assessment or who died prior to their first scheduled response assessment were considered non-responders.|From randomization to the end of study (clinical cut-off; up to 116 weeks).|Randomized Patients||participants|||Number
741442|NCT00473642|Primary|Mean Letters Gained of Best Corrected Visual Acuity Using ETDRS Protocol|Visual acuity is often measured using a chart called the ETDRS chart (Early Treatment Diabetic Retinopathy Study). A letter score is calculated based on the number of letters that can be correctly identified from specified distances. Higher letter scores correspond to better visual acuity. Lower letter scores mean poorer visual acuity. In this study, the number of letters gained over the course of the study. In other words the baseline visual acuity in letters was subtracted from the visual acuity in letters measured at the 12 month visit providing a letter score of vision gain or vision loss.|12 months|||letters||Standard Deviation|Mean
741443|NCT00473642|Secondary|Time to First Retreatment After Loading Doses, Average Number of Retreatments Over 12 Months, Central Macular Thickness on OCT, the Number of Recurrent CNV, the Number of Patients With Persistent CNV After the Mandatory Loading Doses.||12 months||||||
741444|NCT00473642|Primary|Mean Change in BCVA of ETDRS Letters From Baseline at 12 Months||12 months||||||
741445|NCT00473655|Secondary|ApoB Levels|Change in the levels from baseline to end of study|8 weeks|||mg/dl||Standard Deviation|Mean
741446|NCT00473655|Secondary|Adverse Events Reported|Number of participants with AEs and SAEs reported|8 weeks|||Participants|||Number
741447|NCT00473655|Secondary|hsCRP Reduction|Reduction from baseline to end of study|8 weeks|||mg/L||Standard Deviation|Mean
741448|NCT00473655|Secondary|ApoA1 Levels|Change in the levels from baseline to end of study|8 weeks|||mg/dl||Standard Deviation|Mean
741449|NCT00473655|Secondary|HDL-C Increase|Increase from baseline to end of study|8 weeks|||mg/dL||Standard Deviation|Mean
741450|NCT00473655|Secondary|Total Cholesterol Reduction|Reduction from baseline to end of study|8 weeks|||mg/dL||Standard Deviation|Mean
741451|NCT00473655|Secondary|LDL-C Reduction|Reduction from baseline to end of study|8 weeks|||mg/dL||Standard Deviation|Mean
741452|NCT00473655|Secondary|Non-HDL-C Reduction|Reduction from baseline to end of study|8 weeks|||mg/dL||Standard Deviation|Mean
741453|NCT00473655|Primary|Change (Reduction) in Triglycerides Levels From Baseline to End of Treatment (Week 8)|Reduction from baseline to end of study|8 weeks|||mg/dL||Standard Deviation|Mean
741454|NCT00473668|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (Day 0-Month 3)|The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects.||Subjects|||Number
741455|NCT00473668|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Day 0-30) follow-up period post-vaccination|The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects.||Subjects|||Number
741456|NCT00473668|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of any general symptom regardless of intensity grade. Grade 3 Irritability= crying that could not be comforted/prevented normal activity. Grade 3 Drowsiness/Loss of appetite= Drowsiness/Loss of appetite that prevented normal activity. Grade 3 fever = fever above (>) 39.5°C. Related = symptom assessed by the investigator as related to the vaccination.|During the 4-day (Day 0–3) follow-up period post-vaccination|The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects.||Subjects|||Number
741457|NCT00473668|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.|During the 4-day (Day 0–3) follow-up period post-vaccination|The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects.||Subjects|||Number
741458|NCT00473668|Secondary|Concentration of Antibodies Against Bordetella Pertussis (BPT) Antigen|Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL).|At Month 3|The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable for whom immunogenicity data were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
741459|NCT00473668|Secondary|Concentration of Antibodies Against Hepatitis B Surface Antigen (HBs)|Concentrations are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).|At Month 3|The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable for whom immunogenicity data were available.||mIU/mL||95% Confidence Interval|Geometric Mean
741460|NCT00473668|Secondary|Concentration of Antibodies Against Diphtheria (D) and Tetanus (T) Antigens|Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).|At Month 3|The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable for whom immunogenicity data were available.||IU/mL||95% Confidence Interval|Geometric Mean
741461|NCT00473668|Secondary|Concentration of Antibodies Against Polyribosyl-ribitol-phosphate (PRP) Antigens|Concentrations are presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (μg/mL).|At Month 3|The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable for whom immunogenicity data were available.||μg/mL||95% Confidence Interval|Geometric Mean
741462|NCT00473668|Secondary|Number of Subjects With Vaccine Response to Bordetella Pertussis (BPT) Antigen|Vaccine response was defined as: for initially seronegative subjects, antibody concentration greater than or equal to (≥) 15 EL.U/mL; and for initially seropositive subjects, antibody concentration ≥ 1 fold the pre-vaccination antibody concentration.|At Month 3|The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable for whom immunogenicity data were available.||Subjects|||Number
741463|NCT00473668|Secondary|Number of Seropositive Subjects Against Bordetella Pertussis (BPT) Antigen|A seropositive subject was defined as a vaccinated subject with anti-BPT antibody concentration greater than or equal to (≥) 15 ELISA units (EL.U) per milliliter (EL.U/mL).|At Month 3|The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable for whom immunogenicity data were available.||Subjects|||Number
741464|NCT00473668|Secondary|Number of Seropositive Subjects Against Polyribosyl-ribitol-phosphate (PRP) Antigens|Seropositivity was defined as antibody concentrations greater than or equal to (≥) 1 microgram/milliliter (µg/mL).|At Month 3|The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable for whom immunogenicity data were available||Subjects|||Number
741465|NCT00473668|Secondary|Number of Seroprotected Subjects Against Diphteria (D) With Antibody Concentrations Above the Cut-off|Seroprotection cut-off values assessed were greater than or equal to (≥) 0.016 international units per milliliter (IU/mL) in the sera of subjects seronegative before vaccination. Concentrations were assessed via neutralization assay on Vero cells.|At Month 3|The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable for whom immunogenicity data were available.||Subjects|||Number
741466|NCT00473668|Secondary|Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigen|A seroprotected subject is defined as a vaccinated subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL). Seroprotection was assesed via enzyme-linked immunosorbent assay (ELISA).|At Month 3|The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable for whom immunogenicity data were available.||Subjects|||Number
741467|NCT00473668|Secondary|Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)|A seroprotected subject is defined as a vaccinated subject with anti-hepatitis B antibody concentration greater than or equal to (≥) 10 milli-international units per milliliter (mIU/mL).|At Month 3|The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable for whom immunogenicity data were available.||Subjects|||Number
741468|NCT00473668|Primary|Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) Antigens|A seroprotected subject was defined as a subject with anti-PRP concentrations greater than or equal to (≥) 0.15 microgram per milliliter (µg/mL).|At Month 3|The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable for whom immunogenicity data were available.||Participants|||Count of Participants
741469|NCT00473746|Secondary|Phase 2: Duration of Objective Response|Duration of objective response was assessed only in participants who achieved a CR or PR, and measured from the first documented date of response to the first documented date of disease progression according to the RECIST criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 12 weeks from start of treatment|Thirteen evaluable participants with measurable disease at baseline were evaluated for radiographic duration of objective response.||days||95% Confidence Interval|Median
741470|NCT00473746|Secondary|Phase 2: Overall Survival|Overall survival is the time interval from the date of first dose (cycle 1 day 1) of abiraterone acetate therapy to the date of death from any cause.|Up to Month 60|ITT population included all participants who were enrolled into the study.||days||95% Confidence Interval|Median
741471|NCT00473746|Secondary|Phase 2: Participants With Change in Eastern Cooperative Oncology Group (ECOG) Performance Status Score|ECOG performance status score ranges from 0 to 5 where 0=fully active, perform all pre-disease activities without restriction. 1=restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2=ambulatory, capable of self-care, unable to carry out any work activities, up and about more than (>) 50% of waking hours. 3=capable of limited self-care, confined to bed or chair >50% of waking hours. 4=completely disabled, not capable of any self-care, totally confined to bed or chair. 5=dead.|Up to 12 weeks from start of treatment|ITT population included all participants who were enrolled into the study.||participants|||Number
741472|NCT00473746|Secondary|Phase 2: Duration of PSA Response|Duration of PSA response was defined as the duration between the date of confirmed PSA response and subsequent PSA progression date as defined by the PSAWG criteria.|Up to 12 weeks from start of treatment|ITT population included all participants who were enrolled into the study.||days||95% Confidence Interval|Median
741473|NCT00473746|Secondary|Phase 2: Time to PSA Progression|The time interval from the date of first dose of abiraterone acetate therapy to the date of the PSA progression as defined by the PSAWG criteria.|Up to 12 weeks from start of treatment|ITT population included all participants who were enrolled into the study.||days||95% Confidence Interval|Median
741846|NCT00483262|Primary|Best Response to Combination Treatment|Response rate of PR or better to the combination treatment of CCI-779 (Temsirolimus) and bortezomib (Velcade) in patients with relapsed or refractory multiple myeloma|10 months|All patients included in analysis||percentage of patients||90% Confidence Interval|Number
741474|NCT00473746|Secondary|Phase 2: Radiographic Objective Response Rate (RAD-ORR)|The objective response rate is defined as the proportion of participants with measurable lesions achieving a Complete Response (CR) or Partial Response (PR) based on Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 12 weeks from start of treatment|Thirteen evaluable participants with measurable disease at baseline were evaluated for radiographic objective response rate.||participants|||Number
741475|NCT00473746|Secondary|Phase 2: PSA Progression Free Survival (PSA-PFS)|PSA-PFS is the time interval from the date of first dose of abiraterone acetate therapy to the date of death or the PSA progression as defined by the Prostate Specific Antigen Working Group (PSAWG) criteria.|Up to 12 weeks from start of treatment|ITT population included all participants who were enrolled into the study.||days||95% Confidence Interval|Median
741476|NCT00473746|Secondary|Phase 2: Radiographic Progression Free Survival (RAD-PFS)|RAD-PFS is the time interval from the date of first dose of abiraterone acetate therapy to the date of death or radiographic disease progression according to the RECIST (Response Evaluation Criteria In Solid Tumors) criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 12 weeks from start of treatment|ITT population included all participants who were enrolled into the study. RAD-PFS was not analyzed because of insufficient data to provide a meaningful estimate of the median and associated confidence interval (CI)||days||Full Range|Median
741477|NCT00473746|Secondary|Phase 1: Volume of Distribution (Vz_F_obs) of Abiraterone Acetate|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Volume of distribution is normally calculated by using equation volume of distribution =dose/initial concentration. Blood samples for pharmacokinetic (PK) measurements was taken on Day –7 at hour 0 (predose), at hours 1, 2, 4, 6, 8, and 12 (postdose). On Day –6 at 24 hour (postdose) and Day –5 at 48 hour (postdose). On Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 2 and 3 (Predose).|At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3|ITT population included all participants who were enrolled into the study.||Liter (L)||Standard Deviation|Mean
741478|NCT00473746|Secondary|Phase 1: Total Body Clearance (Cl_F_obs) of Abiraterone Acetate|Blood samples for pharmacokinetic (PK) measurements was taken on Day –7 at hour 0 (predose), at hours 1, 2, 4, 6, 8, and 12 (postdose). On Day –6 at 24 hour (postdose) and Day –5 at 48 hour (postdose). On Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 2 and 3 (Predose).|At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3|ITT population included all participants who were enrolled into the study.||liter per hour (l/hr)||Standard Deviation|Mean
741479|NCT00473746|Secondary|Phase 1: Terminal Half-life (HL_Lambda_z) of Abiraterone Acetate|Blood samples for pharmacokinetic (PK) measurements was taken on Day –7 at hour 0 (predose), at hours 1, 2, 4, 6, 8, and 12 (postdose). On Day –6 at 24 hour (postdose) and Day –5 at 48 hour (postdose). On Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 2 and 3 (Predose).|At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3|ITT population included all participants who were enrolled into the study.||hour (hr)||Standard Deviation|Mean
741480|NCT00473746|Secondary|Phase 1: Area Under the Plasma-Concentration-time Curve From Time 0 to Infinite Time (AUCINF_obs) of Abiraterone Acetate|Blood samples for pharmacokinetic (PK) measurements was taken on Day –7 at hour 0 (predose), at hours 1, 2, 4, 6, 8, and 12 (postdose). On Day –6 at 24 hour (postdose) and Day –5 at 48 hour (postdose). On Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 2 and 3 (Predose).|At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3|ITT population included all participants who were enrolled into the study.||hr*nmol/L||Standard Deviation|Mean
741481|NCT00473746|Secondary|Phase 1: Area Under the Plasma-Concentration-Time Curve From Time 0 to the Last Quantifiable Concentration (AUClast) of Abiraterone Acetate|Blood samples for pharmacokinetic (PK) measurements was taken on Day –7 at hour 0 (predose), at hours 1, 2, 4, 6, 8, and 12 (postdose). On Day –6 at 24 hour (postdose) and Day –5 at 48 hour (postdose). On Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 2 and 3 (Predose).|At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3|ITT population included all participants who were enrolled into the study.||hr*nmol/L||Standard Deviation|Mean
741482|NCT00473746|Secondary|Phase 1: Time to Reach the Maximum Plasma Concentration (Tmax) of Abiraterone Acetate|Blood samples for pharmacokinetic (PK) measurements was taken on Day –7 at hour 0 (predose), at hours 1, 2, 4, 6, 8, and 12 (postdose). On Day –6 at 24 hour (postdose) and Day –5 at 48 hour (postdose). On Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 2 and 3 (Predose)|At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3|ITT population included all participants who were enrolled into the study.||hour (hr)||Standard Deviation|Mean
741483|NCT00473746|Secondary|Phase 1: Maximum Plasma Concentration (Cmax) of Abiraterone Acetate|Blood samples for pharmacokinetic (PK) measurements was taken on Day –7 at hour 0 (predose), at hours 1, 2, 4, 6, 8, and 12 (postdose). On Day –6 at 24 hour (postdose) and Day –5 at 48 hour (postdose). On Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 2 and 3 (Predose).|At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3.|ITT population included all participants who were enrolled into the study.||nanomoles per liter (nmol/L)||Standard Deviation|Mean
741484|NCT00473746|Primary|Phase 2: Participants With Greater Than or Equal to 50 Percent Decline in Prostate Specific Antigen (PSA)|Number of participants with greater than or equal to 50 percent decrease in PSA levels were assessed. PSA decline was evaluated according to (Prostate Specific Antigen Working Group) PSAWG criteria. Decrease in PSA levels represented improvement.|Up to 12 weeks from start of treatment|Intent-to-treat (ITT) population included all participants who were enrolled into the study.||participants|||Number
742298|NCT00493012|Primary|Change in Body Weight From Baseline to 12 Months||baseline, 12 months|||kg||Standard Deviation|Mean
741485|NCT00473746|Primary|Phase 1: Maximum Tolerated Dose (MTD) of Abiraterone Acetate|The MTD is the highest dose of a drug or treatment that does not cause unacceptable side effects.|Up to Cycle 12|Safety population included all enrolled participants who received any study drug. MTD of abiraterone acetate was not reached because the doses administered appear to be well tolerated with no Dose Limiting Toxicity (DLT) even at 1000 milligram per day (mg/day [recommended maximum dose for phase 1]) and 1000 mg/day was taken as test dose in phase 2.||mg/day|||Number
741486|NCT00473824|Primary|Post Transplant Reduction in Viral Load (as Measured Quantitatively by Hepatitis C Virus (HCV) Reverse Transcription-Polymerase Chain Reaction (HCV RT-PCR)).|Proportion of subjects who achieve reduction in viral load from the baseline pre-transplant value. Baseline is the pre-transplant HCV viral load as measeured by RT-PCR. Post-transplant HCV viral load is determined at both 1 month and 6 months post-tranplant.|Outcome evaluations at 1 month (Day 28) and 6 months ( 24 weeks) post-tranplant.|As the study was terminated early and since no participant in either arm achieved reduction in viral load, it was recorded that zero particpants and zero percent in each arm achieved reduction in viral load.||percentage of participants|||Number
741487|NCT00473837|Secondary|Curve of Hb Change Between Day 3 and Day 30 in the Two Placebo Arms; Changes in Markers of Iron Status, Measures of Inflammation, and Hb Response Between Day 3 and Day 30, and Between Day 3 and Day 90||90 days||||||
741488|NCT00473837|Primary|Changes in Haemoglobin Concentration From Day 3 Post Treatment of Malaria Episode to Day 90 in the Weekly Chloroquine and Placebo Arms||90 days|||g/L||Standard Deviation|Mean
741489|NCT00473876|Secondary|Possible Mechanisms That Can Explain the Improvement of Exercise Capacity|VE/VCO2 Slope, measurement of the abnormal ventilatory response to exercise identified by an increased slope of ventilation (L/min) vs. CO2 production (VE/VCO2) (L/min) to incremental workload|4 months|39 patients were randomized with 3 dropped out. Therefore, 36 were included in the analysis. There was 1 patient who dropped out in the placebo arm and hence 22 patients were analysed.||Unitless||Standard Deviation|Mean
741490|NCT00473876|Primary|Peak VO2|Peak VO2 after 4 months of intervention with either metformin or placebo. The Mean difference between baseline and after 4 months was analyzed using t-test comparing metformin and placebo.|4 months|.In the metformin group,3 patients were lost to follow up therefore excluded from analysis.5 patients were discontinued on medications due to side effects, however,were included in our intention to treat analysis.In the placebo group,1 patient was lost to follow up and was excluded from analysis||ml/kg/min||Standard Deviation|Mean
741491|NCT00473889|Secondary|Number of Participants Who Had a Disease Response to Treatment|Response to treatment is defined as a complete response (CR) or partial response (PR) to treatment. Confirmation of response required a second assessment performed at least 4 weeks after the initial assessment. (PR is defined as at least a 30% reduction in sum of the longest diameter of all target lesions and no increase in non-target lesions).|Every 42 days from start of treatment until disease response|"Full analysis set
(FAS) population is defined as all randomized participants who have received at least one dose of study medication. There are 253 participants randomized in the study. Five (5) didn't take any study medication. Therefore, 248 participants are included in this analysis population."||Participants|||Number
741492|NCT00473889|Secondary|Progression Free Survival|Defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first. Disease progression is defined as at least a 20% increase in sum of the longest diameter of all target lesions, the appearance of a new lesion, or an increase in non-target lesions.|Start of treatment to disease progression or death|"Full analysis set
(FAS) population defined as all randomized participants who have received at least one dose of study medication. There are 253 participants randomized in the study 5 didn't take any study medication. Therefore, 248 participants are included in this analysis population."||Months||Full Range|Median
741493|NCT00473889|Primary|Overall Survival|Defined as the time from date of randomization to death due to any cause. Patients without documented death at the time of the final analysis will be censored at the date of the last follow-up.|Start of treatment to death|Intention-to-treat (ITT) population is defined as all randomized participants. Participants are counted in the group to which they are randomized.||Months||Full Range|Median
741494|NCT00474045|Secondary|Ratio Between Cross-reacting Antibodies in Cord Blood and Maternal Antibodies|Cord blood (at delivery) vs. Maternal Blood at Visit P4 (GW 36)|At Delivery (End of Pregnancy) and at Visit P4 (GW 36)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial.||ratio||Full Range|Median
741495|NCT00474045|Secondary|Ratio Between Aspart Specific Antibodies in Cord Blood and Maternal Antibodies|Cord blood (at delivery) vs. Maternal Blood at Visit P4 (GW 36)|At Delivery (End of Pregnancy) and at Visit P4 (GW 36)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial.||ratio||Full Range|Median
741496|NCT00474045|Secondary|Safety - Composite Pregnancy Outcome|Wt. corresponds to weight of live-born infants. Pre-term delivery: delivery before 37 completed GWs including abortions. Early foetal death: death before 22 completed GWs. Perinatal mortality: death of a foetus/infant between ≥ 22 completed GWs and < 1 completed week after delivery. Neonatal mortality: post-partum after 7 completed days and before 28 completed days after delivery. Major-malformation: a life threatening structural anomaly or one likely to cause significant impairment of health or functional capacity and needs medical or surgical treatment.|End of Pregnancy|Safety analysis set (pregnant subjects): randomised subjects exposed to at least 1 dose of trial product and pregnant during the trial. IDet (N)=152 (152 pregnancies) NPH (N)=158 subjects (160 pregnancies, 2 subjects had spontaneous abortion and became pregnant again).||participants|||Number
741497|NCT00474045|Secondary|Safety - Total Daily Insulin Dose During Pregnancy||Visit P2 (GW 14), Visit P3 (GW 24), Visit P4 (GW 36), Follow-Up (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial.||U/kg||Standard Deviation|Mean
741511|NCT00474045|Secondary|Pregnancy Outcome Safety - Level of Aspart Specific Antibodies (AB) in Umbilical Cord Blood|Antibodies were measured in a subtraction radioimmunoassay and expressed as antibody bound tracer relative to the total amount of tracer (%B/T)|At Delivery (End of Pregnancy)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial.||%B/T||Full Range|Median
748837|NCT00538642|Secondary|HDL Cholesterol||Baseline|||mg/dL||Standard Deviation|Mean
741498|NCT00474045|Secondary|Pregnancy Outcome at Follow-Up|Induced abortion means interruption of a living pregnancy < 22 completed weeks. Early foetal death means death before 22 completed GWs. Perinatal Death means death of a foetus/infant between ≥ 22 completed GWs and < 1 completed week after delivery. Neonatal Death means death between at or after 7 completed days and before 28 completed days after delivery. Death During Follow-Up means death between at or after 28 days after delivery and at or before Follow-Up.|Follow-Up (6 weeks after delivery)|Safety analysis set (pregnant subjects): randomised subjects exposed to at least 1 dose of trial product and preg. during the trial. IDet (N)=152 (152 pregnancies) NPH (N)=158 subjects (160 pregnancies, 2 subjects had spontaneous abortion and became preg. again). Analysed subjects-no. of subjects with a preg. outcome at delivery visit.||participants|||Number
741499|NCT00474045|Secondary|Pregnancy Outcome at Delivery|Induced abortion means interruption of a living pregnancy < 22 completed weeks. Early foetal death means death before 22 completed GWs. Stillbirth indicates death between at or after 22 GW and at or before delivery.|Delivery Visit|Safety analysis set (pregnant subjects): randomised subjects exposed to at least 1 dose of trial product and preg. during the trial. IDet (N)=152 (152 pregnancies) NPH (N)=158 subjects (160 pregnancies, 2 subjects had spontaneous abortion and became preg. again). Analysed subjects-no. of subjects with a preg. outcome at delivery visit.||participants|||Number
741500|NCT00474045|Secondary|Maternal Safety - Mode of Delivery|Non-Planned Caesarean Section is a procedure which takes place ≤8h prior to delivery. Planned Caesarean Section takes place >8h prior to delivery.|At Delivery Visit|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. This set in total contains 152 subjects in IDet and 158 subjects in NPH arm. The partcipant analysed for this outcome measure are the number of subjects at delivery visit.||percentage (%) of subjects|||Number
741501|NCT00474045|Secondary|Maternal Safety - Acceleration of Nephropathy|Acceleration of nephropathy was defined as a change from a low U-albumin:U-creatinine ratio ≤33.93 mg/mmol to a high U-albumin:U-creatinine ratio > 33.93 mg/mmol from GW 8-12 (Visit P1) to the follow-up visit.|From GW 8-12 (Visit P1) to Follow-Up (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Acceleration of nephropathy was summarised by treatment and missing data was imputed using LOCF.||participants|||Number
741502|NCT00474045|Secondary|Maternal Safety - Acceleration of Retinopathy in Any Eye|Acceleration of Retinopathy is defined as worsening of fundoscopy/fundusphotography findings from GW 8-12 (Visit P1) to follow-up on one or both eyes.|From GW 8-12 (Visit P1) to Follow-Up (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Acceleration of retinopathy was summarised by treatment and missing data was imputed using LOCF.||participants|||Number
741503|NCT00474045|Secondary|Maternal Safety - Electrocardiogram (ECG)|The number of subjects having a electrocardiogram (ECG) that changed from 'Normal' or 'Abnormal, not clinically significant' (at Visit 1, 3 weeks before randomisation) to 'Abnormal, clinically significant' (at Follow-Up). 'Abnormal, Clinically significant' is an abnormality that suggests a disease and/or organ toxicity and is of a severity, which requires active management.|Follow-Up (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial.||participants|||Number
741504|NCT00474045|Secondary|Maternal Safety - Change From Visit P1 in Pulse During Pregnancy and at Follow-Up|Change in the pulse was summarised by treatment.|Visit P1 (GW (8-12), Visit P2 (GW 14), Visit P3 (GW 24), Visit P4 (GW 36), Follow-Up Visit (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Missing values were imputed using LOCF.||beats/minute||Standard Deviation|Mean
741505|NCT00474045|Secondary|Maternal Safety - Change From Visit P1 in Diastolic Blood Pressure During Pregnancy and at Follow-Up by Visit|Change in the diastolic blood pressure was summarised by treatment.|Visit P1 (GW (8-12)), Visit P2 (GW 14), Visit P3 (GW 24), Visit P4 (GW 36), Follow-Up (FU) Visit (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Missing values were imputed using LOCF.||mmHg||Standard Deviation|Mean
741506|NCT00474045|Secondary|Maternal Safety - Change From Visit P1 in Systolic Blood Pressure During Pregnancy and at Follow-Up by Visit|Change in the systolic blood pressure was summarised by treatment.|Visit P1 (GW (8-12)), Visit P2 (GW 14), Visit P3 (GW 24), Visit P4 (GW 36), Follow-Up (FU) Visit (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Missing values were imputed using LOCF.||mmHg||Standard Deviation|Mean
741507|NCT00474045|Secondary|Maternal Safety - Change From Visit P1 in Body Weight During Pregnancy by Visit|Change in the body weight was summarised by treatment.|Visit P1 (GW (8-12), Visit P2 (GW 14), Visit P3 (GW 24), Visit P4 (GW 36)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Missing values were imputed using LOCF.||kg||Standard Deviation|Mean
741508|NCT00474045|Secondary|Pregnancy Outcome Safety - Level of Insulin Detemir in Umbilical Cord Blood||At Delivery|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. IDet in cord blood was analysed for subjects in the IDet Arm and only for 98 subjects, as for 72 subjects it was reported as below measuring range (<25.00 pmol/L).||pmol/L||Full Range|Median
741509|NCT00474045|Secondary|Ratio Between Detemir Specific Antibodies in Cord Blood and Maternal Antibodies|Cord blood (at delivery) vs. Maternal Blood at Visit P4 (GW 36)|At Delivery (End of Pregnancy) and at Visit P4 (GW 36)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial.||ratio||Full Range|Median
741510|NCT00474045|Secondary|Pregnancy Outcome Safety - Level of Cross-Reacting Antibodies (AB) in Umbilical Cord Blood|Antibodies were measured in a subtraction radioimmunoassay and expressed as antibody bound tracer relative to the total amount of tracer (%B/T).|At Delivery (End of Pregnancy)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial.||%B/T||Full Range|Median
744653|NCT00503113|Secondary|Relative Change From Baseline in Mean Serum Creatinine.||Baseline and 9 months|PP Population||mg/dL||Standard Deviation|Mean
741512|NCT00474045|Secondary|Pregnancy Outcome Safety - Level of Detemir Specific Antibodies (AB) in Umbilical Cord Blood|Antibodies were measured in a subtraction radioimmunoassay and expressed as antibody bound tracer relative to the total amount of tracer (%B/T).|At Delivery (End of Pregnancy)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial.||%B/T||Full Range|Median
741513|NCT00474045|Secondary|Maternal Safety - Change in Insulin Detemir/Insulin Aspart Cross Reacting Antibodies|Change in concentrations values for insulin detemir/aspart cross-reacting antibodies from baseline to Visit P4 was calculated. The unit for measuring antibody levels is amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture (%B/T). Samples were taken before 1st dosing|Baseline, Visit P4 (GW 36). Baseline is Visit 2 (randomisation visit, within 3 weeks of screening) for subjects not pregnant at randomisation and Visit P1 (GW 8-12) for pregnant subjects at randomisation.|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial.||%B/T||Full Range|Median
741514|NCT00474045|Secondary|Maternal Safety - Change in Insulin Aspart Specific Antibodies|Change in concentrations values for insulin aspart specific antibodies from baseline to Visit P4 was calculated. The unit for measuring antibody levels is amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture (%B/T). Samples were taken before 1st dosing.|Baseline, Visit P4 (GW 36). Baseline is Visit 2 (randomisation visit, within 3 weeks of screening) for subjects not pregnant at randomisation and Visit P1 (GW 8-12) for pregnant subjects at randomisation.|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial.||%B/T||Full Range|Median
741515|NCT00474045|Secondary|Maternal Safety - Change in Insulin Detemir Specific Antibodies|Change in concentrations of values for insulin detemir specific antibodies from baseline to Visit P4 was calculated. The unit for measuring antibody levels is amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture (%B/T). Samples were taken before 1st dosing.|Baseline, Visit P4 (GW 36). Baseline is Visit 2 (randomisation visit, within 3 weeks of screening) for subjects not pregnant at randomisation and Visit P1 (GW 8-12) for pregnant subjects at randomisation.|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial.||%B/T||Full Range|Median
741516|NCT00474045|Secondary|Maternal Safety - Change in Urine N (Creatinine) (Urinalysis)|This is the standard safety lab parameter and calculated as an estimate of the mean change from Visit P1 in Urine-N (creatinine) level at Follow-Up Visit (6 weeks after delivery).|Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Missing data was imputed using LOCF.||mg/dL||Standard Deviation|Mean
741517|NCT00474045|Secondary|Maternal Safety - Change in Albumin/Creatinine Ratio (Urinalysis)|This is the standard safety lab parameter and calculated as an estimate of the mean change from Visit P1 in albumin/creatinine ratio at Follow-Up Visit (6 weeks after delivery).|Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Missing data was imputed using LOCF.||mg/mmol||Standard Deviation|Mean
741518|NCT00474045|Secondary|Maternal Safety - Change in Urine Albumin Level (Urinalysis)|This is the standard safety lab parameter and calculated as an estimate of the mean change from Visit P1 in urine albumin level at Follow-Up Visit (6 weeks after delivery).|Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Missing data was imputed using LOCF.||g/dL||Standard Deviation|Mean
741519|NCT00474045|Secondary|Maternal Safety - Change in Thrombocytes Level (Haematology)|This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in thrombocytes level at Follow-Up Visit (6 weeks after delivery).|Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Missing data was imputed using LOCF.||10^9 cells/L||Standard Deviation|Mean
741520|NCT00474045|Secondary|Maternal Safety - Change in Leukocytes Level (Haematology)|This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in leukocytes level at Follow-Up Visit (6 weeks after delivery).|Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Missing data was imputed using LOCF.||10^9 cells/L||Standard Deviation|Mean
741521|NCT00474045|Secondary|Maternal Safety - Change in Haemoglobin Level (Haematology)|This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in haemoglobin level at Follow-Up Visit (6 weeks after delivery).|Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Missing data was imputed using LOCF.||mmol/L||Standard Deviation|Mean
741522|NCT00474045|Secondary|Maternal Safety - Change in Total Protein Serum Level (Biochemistry)|This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in total protein serum level at Follow-Up Visit (6 weeks after delivery).|Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial.Missing data was imputed using LOCF.||g/dL||Standard Deviation|Mean
741523|NCT00474045|Secondary|Maternal Safety - Change in Sodium Serum Level (Biochemistry)|This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in sodium serum level at Follow-Up Visit (6 weeks after delivery).|Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Missing data was imputed using LOCF.||mmol/L||Standard Deviation|Mean
744654|NCT00503113|Secondary|Absolute Change From Baseline in Mean Serum Creatinine.||Baseline and 9 months|PP Population||mg/dL||Standard Deviation|Mean
741524|NCT00474045|Secondary|Maternal Safety - Change in Potassium Serum Level (Biochemistry)|This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in potassium serum level at Follow-Up Visit (6 weeks after delivery).|Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Missing data was imputed using LOCF.||mmol/L||Standard Deviation|Mean
741525|NCT00474045|Secondary|Maternal Safety - Change in Lactate Dehydrogenase Serum Level (Biochemistry)|This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in lactate dehydrogenase serum level at Follow-Up Visit (6 weeks after delivery).|Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Missing data was imputed using LOCF.||U/L||Standard Deviation|Mean
741526|NCT00474045|Secondary|Maternal Safety - Change in Creatinine Serum Level (Biochemistry)|This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in creatinine serum level at Follow-Up Visit (6 weeks after delivery).|Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Missing data was imputed using LOCF.||mcmol/L||Standard Deviation|Mean
741527|NCT00474045|Secondary|Maternal Safety - Change in Alkaline Phosphatase Serum Level (Biochemistry)|This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in alkaline phosphatase level at Follow-Up Visit (6 weeks after delivery).|Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Missing data was imputed using LOCF.||U/L||Standard Deviation|Mean
741528|NCT00474045|Secondary|Maternal Safety - Change in Alanine Aminotransferase Serum Level (Biochemistry)|This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in alanine aminotransferase level at Follow-Up Visit (6 weeks after delivery).|Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Missing data was imputed using LOCF.||U/L||Standard Deviation|Mean
741529|NCT00474045|Secondary|Maternal Safety - Change in Albumin Serum Level (Biochemistry)|This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in albumin level at Follow-Up Visit (6 weeks after delivery).|Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Missing data was imputed using LOCF.||g/dL||Standard Deviation|Mean
741530|NCT00474045|Secondary|Maternal Safety - Nocturnal Hypoglycaemic Episodes|A nocturnal episode is any episode occurring between 0.01 - 5.59, both including. It includes major, minor and symptoms only episodes. Major: unable to self-treat. Minor: able to self-treat and plasma glucose (PG) < 3.1 mmol/L. Symptoms only: able to self-treat and no PG measurement or PG glucose ≥3.1 mmol/L.|Participants were followed during the pregnancy period, an average of 9.6 months|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial.||episodes|||Number
741531|NCT00474045|Secondary|Maternal Safety - Hypoglycaemic Episodes|All episodes include major, minor and symptoms only. Major episode : unable to self-treat. Minor: able to self-treat and plasma glucose (PG) < 3.1 mmol/L. Symptoms only: able to self-treat and no PG measurement or PG glucose ≥3.1 mmol/L. Diurnal: Episode occurring between 06.00 - 00.00, both including.|Participants were followed during the pregnancy period, an average of 9.6 months|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial.||episodes|||Number
741532|NCT00474045|Secondary|Safety in Children - Number of Subjects (Foetuses and Newborns) With Adverse Events|AE=any undesirable medical event occurring to a subject in a clinical trial, whether or not related to the trial product. Related AE=relationship of probable or possible. SAE=any undesirable serious medical event as defined in protocol.|Foetuses/Newborns were followed during the pregnancy period, an average of 9.6 months and Follow-Up period (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Each pregnant woman analyzed had exactly one Foetus/Newborn that was analyzed for AEs.||Foetus/Newborns (1 per pregnant woman)|||Number
741533|NCT00474045|Secondary|Maternal Safety - Number of Subjects With Adverse Events (AEs)|AE=any undesirable medical event occurring to a subject in a clinical trial, whether or not related to the trial product. Related AE=relationship of probable or possible. Serious adverse event (SAE) =any undesirable serious medical event as defined in protocol.|Participants were followed during the pregnancy period, an average of 9.6 months|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial.||participants|||Number
741534|NCT00474045|Secondary|8-point Self Monitored Plasma Glucose (SMPG) Profile at GW 36|8-point SMPG was recorded 3 times prior to each visit, and the average value for each of the 8-time points was applied when presenting and analysing the SMPG data. Visit reallocation was made for the early termination visit and for the withdrawal visit.|Visit P4 (GW 36)|Full Analysis Set (FAS) for pregnant subjects-all randomised subjects exposed to at least 1 dose of trial drug and pregnant during trial. IDet (N)=152 & NPH (N)=158. Missing values were imputed using Last observation carried forward (LOCF). For FAS, LOCF was made using the average values.||mmol/L||Standard Deviation|Mean
741535|NCT00474045|Secondary|8-point Self-monitored Plasma Glucose (SMPG) Profile at GW 24|8-point SMPG was recorded 3 times prior to each visit, and the average value for each of the 8-time points was applied when presenting and analysing the SMPG data. Visit reallocation was made for the early termination visit and for the withdrawal visit.|Visit P3 (GW 24)|Full Analysis Set (FAS) for pregnant subjects-all randomised subjects exposed to at least 1 dose of trial drug and pregnant during trial. IDet (N)=152 & NPH (N)=158. Missing values were imputed using Last observation carried forward (LOCF). For FAS, LOCF was made using the average values.||mmol/L||Standard Deviation|Mean
748838|NCT00538642|Secondary|Cholesterol||4-5 months|||mg/dL||Standard Deviation|Mean
741536|NCT00474045|Secondary|Fasting Plasma Glucose (FPG)||During the pregnancy period [Visit P1 (GW 8-12), Visit P2 (GW 14), Visit P3 (GW 24), Visit P4 (GW 36)]|Full Analysis Set (FAS) for pregnant subjects-all randomised subjects exposed to at least 1 dose of trial drug and pregnant during trial. IDet (N)=152 and NPH (N)=158. Missing values were imputed using Last observation carried forward (LOCF). For FAS, LOCF was made using the pregnancy visits, the early termination visit and the withdrawal visit.||mmol/L||Standard Deviation|Mean
741537|NCT00474045|Secondary|Subjects Reaching HbA1c at or Below 6.0% Both at GW 24 and GW 36||At both Visit P3 (GW 24) and Visit P4 (GW 36)|FAS for pregnant subjects-all randomised subjects exposed to at least 1 dose of trial drug and pregnant during trial. IDet (N)=152 and NPH (N)=158. Missing values were imputed using LOCF which was made using pregnancy visits, early termination visit and withdrawal visit. Analysed subjects-subjects with valid HbA1c values at visit P3 and P4.||participants|||Number
741538|NCT00474045|Secondary|Glycosylated Haemoglobin (HbA1c) During Pregnancy||During the pregnancy period [Visit P1 (GW 8-12), Visit P2 (GW 14), Visit P3 (GW 24), Visit P4 (GW 36), Delivery Visit (end of pregnancy)] and Follow-Up Visit ( 6 weeks after delivery)|Full Analysis Set (FAS) for pregnant subjects-all randomised subjects exposed to at least 1 dose of trial drug and pregnant during trial. IDet (N)=152 and NPH (N)=158. Missing values were imputed using Last observation carried forward (LOCF). For FAS, LOCF was made using the pregnancy visits, the early termination visit and the withdrawal visit.||Percent (%) glycosylated haemoglobin||Standard Deviation|Mean
741539|NCT00474045|Primary|Glycosylated Haemoglobin (HbA1c) for Per Protocol Analysis Set (Pregnant Subjects) at GW 36||At gestational week (GW) 36|Per Protocol Analysis Set (pregnant subjects): comprised all subjects from the FAS (pregnant subjects) except subjects who significantly violated the inclusion/exclusion criteria. Gestational age at delivery must be at least 32 completed weeks.||Percent (%) glycosylated haemoglobin||Standard Error|Least Squares Mean
741540|NCT00474045|Primary|Glycosylated Haemoglobin (HbA1c) for Full Analysis Set (Pregnant Subjects) at GW 36||At gestational week (GW) 36|Full Analysis Set (FAS) for pregnant subjects-all randomised subjects exposed to at least 1 dose of trial drug and pregnant during trial. IDet (N)=152 and NPH (N)=158. Missing values were imputed using Last observation carried forward (LOCF). For FAS, LOCF was made using the pregnancy visits, the early termination visit and the withdrawal visit.||Percent (%) glycosylated haemoglobin||Standard Error|Least Squares Mean
741541|NCT00474058|Secondary|Change in Number of Nocturias|Nocturia is the need to get up during the night and interrupt sleep in order to urinate. It is a typical nocturnal symptom of Parkinson´s disease. The change from baseline in number of nocturias was used to evaluate improvements in sleep disorders.|From baseline to end of maintenance (after 4 weeks maintenance)|Full Analysis Set (FAS).||nocturias||Standard Deviation|Mean
741542|NCT00474058|Secondary|Change in Nocturnal Akinesia, Dystonia, and Cramps Score (NADCS)|Subjects were asked to assess nocturnal akinesia, dystonia and cramps, using an ordinal severity scale. While a score of 0= normal and 4= maximal severity, subjects could also rate their symptoms with values of 0.5, 1.5, 2.5, 3.5. The nocturnal akinesia score was used to evaluate motor performance while the dystonia and cramps scores were used to evaluate sleep.|From baseline to end of maintenance (after 4 weeks maintenance)|Full Analysis Set (FAS).||units on a scale||Standard Deviation|Mean
741543|NCT00474058|Primary|Change in Parkinson's Disease Sleep Scale (PDSS)|The Parkinson´s Disease Sleep Scale (PDSS) is a questionnaire with 15 questions to assess sleep and nocturnal disability in Parkinson´s disease. The item- scores can range between 0= never and 4= very often. The PDSS score is a sumscore of all 15 questions.|From baseline to end of maintenance (after 4 weeks maintenance)|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).||units on a scale||Standard Deviation|Mean
741544|NCT00474058|Primary|Change in Early Morning UPDRS Part III Score|The Unified Parkinson´s Disease Rating Scale Part III score is an accepted and validated sumscore of 14 items for the assessment of motor function in Parkinson´s disease. Each of the 14 items in the UPDRS part III is measured on a scale of 0 to 4, where 0 is normal and 4 represents severe abnormalities.|From baseline to end of maintenance (after 4 weeks maintenance)|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).||units on a scale||Standard Deviation|Mean
741545|NCT00474123|Secondary|Endothelial Progenitor Cells|Endothelial progenitor cells were evaluated by flow cytometry. Selected cells were positive for CD31, CD34 and VEGFR receptors.|Fasting venous blood samples were drawn immediately after randomization and at the conclusions of the six week study period.|||percentage||Standard Deviation|Mean
741546|NCT00474123|Secondary|Triglyceride||Fasting venous blood samples were drawn immediately after randomization and at the conclusions of the six week study period.|||percentage||Standard Deviation|Mean
741547|NCT00474123|Secondary|LDL Cholesterol||Fasting venous blood samples were drawn immediately after randomization and at the conclusions of the six week study period.|||percentage||Standard Deviation|Mean
741548|NCT00474123|Primary|Interleukin-6|A commercial ELISA assay detecting IL-6 (Siemens, USA) was applied.|Fasting venous blood samples were drawn immediately after randomization and after at the conclusions of the six weeks study period.|||percentage||Inter-Quartile Range|Median
741549|NCT00474123|Primary|Soluble CD40 Ligand|A commercial ELISA assay detecting sCD40L (R&D Systems, USA) was applied. Detection limits and intra-assay variability was respectively, as follows: sCD-40L 15.6 pg/mL (intra-assay variability not available).|Fasting venous blood samples were drawn immediately after randomization and after at the conclusions of the six weeks study period.|||percentage||Standard Deviation|Mean
741550|NCT00474123|Primary|Soluble Intercellular Adhesion Molecule (sICAM)-1|serum samples were stored at -70°C and were determined simultaneously by ELISA in order to avoid variation of assay conditions. Commercial ELISA assays detecting MCP-1/ICAM-1 (R&D Systems, Europe, Abingdon, UK)|Change from baseline at 6 weeks|per protocol||percentage||Standard Deviation|Mean
741551|NCT00474123|Primary|Monocyte Chemoattractant Protein (MCP)-1|Serum samples were stored at -70°C and were determined simultaneously by ELISA in order to avoid variation of assay conditions. Commercial ELISA assays detecting MCP-1/ICAM-1 (R&D Systems, Europe, Abingdon, UK).|Change from baseline at 6 weeks|per protocol||percentage||Standard Deviation|Mean
741552|NCT00474123|Primary|Platelet Function Analyzer [PFA]-100|Samples were collected in 3.8% sodium citrate (buffered, pH 5.5, Vacutainer, Becton Dickinson, Plymouth, UK) for platelet function tests. Platelet function assays were processed within 2 hours of blood collection. The PFA-100 records the closure time (CT), witch means the time in seconds (s) from the start of the test until the platelet plug occludes the aperture.|Change from baseline at 6 weeks|per protocol||Percentage||Standard Deviation|Mean
741554|NCT00474123|Primary|C-reactive Protein|Serum was separated by centrifugation from the blood samples. For high-sensitivity C-Reactive Protein measurement, whole venous blood was collected in tubes without anticoagulant and centrifuged at room temperature. Serum C-Reactive Protein was assessed with a high-sensitivity, latex microparticle-enhanced immunoturbidimetric assay (Behring Nephelometer Analyzer System; Behring Diagnostics, Somerville, NJ).|Change from baseline at 6 weeks|per protocol||Percentage||Inter-Quartile Range|Median
741555|NCT00474175|Other Pre-specified|Dosing Compliance Calculated by Evaluating Percentage of Participants Who Applied no More Than 400 mg of the Study Medication||Baseline and 5 minutes|Safety population included all participants who received at least 1 dose of study medication and had follow up data.||Percentage of participants||95% Confidence Interval|Number
741556|NCT00474175|Other Pre-specified|Dosing Compliance Calculated by Evaluating Amount of Study Medication Applied|Amount of study medication applied was calculated by weighing medication tube prior and post-dosing.|Baseline and 5 minutes|Safety population included all participants who received at least 1 dose of study medication and had follow up data.||Milligram (mg)||Standard Deviation|Mean
741557|NCT00474175|Secondary|Global Satisfaction Assessment|Participants were asked to provide an overall assessment of their satisfaction with the study medication on a categorical scale. Response in this scale was assigned values as 0 (Poor), 1 (Fair), 2 (Good), 3 (Very Good) and 4 (Excellent).|120 minutes|ITT population included all randomized participants who received study medication.||Units on a scale||Standard Deviation|Mean
741558|NCT00474175|Secondary|Pain Relief Combined With Pain Intensity Difference (PRID) Scores|PRID is sum of PID and DPRS scores at each post-dosing time point. The overall possible score range, for PRID is -1 (worst) to 7 (best). PID was calculated as baseline DPS minus DPS score at given time point (DPS range from 0 [none] to 3 [severe]; baseline DPS range from 2-3). PID score ranges from -1 (worst) to 3 (best). DPRS is 5-point scale ranging from 0 (No-relief) to 4 (Complete).|5 to 120 minutes|ITT population included all randomized participants who received study medication.||Units on a scale||Standard Deviation|Mean
741559|NCT00474175|Secondary|Time to Dropping Out Due to Lack of Efficacy or Rescue Medication|Median time of dropping out of the participants from the study due to lack of efficacy or rescue medication (ibuprofen 200-400 mg or acetaminophen 1000 mg), whichever comes first.|0 to 120 minutes|ITT population included all randomized participants who received study medication.||Minutes||95% Confidence Interval|Median
741560|NCT00474175|Secondary|Sum of Pain Relief Combined With Pain Intensity Differences (SPRID) Scores|SPRID is time-weighted sum of pain relief scores combined with pain intensity difference (PRID) scores over 60 and 120 minutes. SPRID score range was 0 (worst) to 7 (best) for SPRID 60 and 0 (worst) to 14 (best) for SPRID 120. PRID is sum of Pain intensity differences (PID) and Dental pain relief scale (DPRS) scores at each post-dosing time point. PID was calculated as baseline DPS minus DPS score at given time point (DPS range: 0 [none] to 3 [severe]; baseline DPS range from 2-3). PID score ranges from -1 (worst) to 3 (best). DPRS is 5-point scale ranging from 0 (No-relief) to 4 (Complete).|60 minutes and 120 minutes|ITT population included all randomized participants who received study medication.||Units on a scale||Standard Deviation|Mean
741561|NCT00474175|Secondary|Duration of Effect|Duration of effect was defined as the time difference between onset of effect and its offset. Onset of effect was the first time point at which two consecutive pain scores less severe than at baseline by at least 1 unit (on the DPS) were attained. Offset of effect was the first of the following events to occur after onset: time to drop out if the drop out was due to lack of efficacy, time of rescue medication, or the first time point following onset of effect at which two consecutive pain scores that are at least as severe as at baseline were attained.|0 to 120 minutes|ITT population included all randomized participants who received study medication.||Minutes||95% Confidence Interval|Median
741562|NCT00474175|Secondary|Time to Meaningful Relief|Participants evaluated the time to meaningful relief by stopping a second stopwatch labeled ‘meaningful relief' at the moment they first began to experience meaningful relief. Stopwatch was active up to 120 minutes after dosing or until stopped by the participant, or rescue medication was administered.|0 to 120 minutes|ITT population included all randomized participants who received study medication.||Minutes||95% Confidence Interval|Median
741563|NCT00474175|Secondary|Time to First Confirmed Perceptible Relief|Participants evaluated the time to first perceptible relief by stopping a stopwatch labeled 'first perceptible relief' at the moment they first began to experience any relief. Stopwatch was active up to 120 minutes after dosing or until stopped by the participant, or rescue medication was administered.|0 to 120 minutes|ITT population included all randomized participants who received study medication.||Minutes||95% Confidence Interval|Median
741564|NCT00474175|Primary|Percentage of Participants With a Response|Responder was defined as participant experiencing improvement in pain intensity, as exhibited by a pain score reduction on the Dental Pain Scale (DPS) from baseline of at least 1 unit for two consecutive assessments anytime between the 5 and 20-minute time points. Response in DPS scale was assigned values as 0 (None), 1 (Mild), 2 (Moderate) and 3 (Severe).|Baseline, 5, 10, 15 and 20 minutes|Intent to treat (ITT) population included all randomized participants who received study medication.||Percentage of participants|||Number
741565|NCT00474188|Secondary|Progression-free Survival|"Time from the start of study drug therapy to the first observation of disease progression or death due to any cause.
Study terminated prematurely. Analysis not conducted."|One year|||Days||95% Confidence Interval|Median
741566|NCT00474188|Secondary|Time to Progression|"Time from the start of study drug therapy to the first documentation of disease progression.
Study terminated prematurely. Analysis not conducted."|One year|||Days||95% Confidence Interval|Median
741567|NCT00474188|Secondary|Duration of Response|"Time from first demonstration of at least a partial response to the first documentation of disease progression, including death due to non-Hodgkin's lymphoma.
Study terminated prematurely. Analysis not conducted."|One year|||Days||95% Confidence Interval|Median
741568|NCT00474188|Secondary|Tumor Control Rate|"Number of participants demonstrating complete tumor response, partial tumor response, or stable disease.
Study terminated prematurely. Analysis not conducted."|One Year|||Participants||95% Confidence Interval|Mean
741569|NCT00474188|Primary|Tumor Response Rate|"Number of participants demonstrating complete or partial tumor response (Cheson B, Horning S, Coiffier B, Shipp M, Fisher R, Connors J, et al, Report of an international workshop to standardize response criteria for non-Hodgkins' lymphoma. J Clin Oncol.1999;17:1244-53).
Study terminated prematurely. Analysis not conducted."|One Year|Study terminated prematurely. Analyses of efficacy not conducted.||Participants||95% Confidence Interval|Mean
741570|NCT00474201|Primary|Gemfibrozil Area Under the Concentration vs. Time Curve (AUC)|AUC (ng*hr/mL) of gemfibrozil when given as a 600 mg dose by itself compared to gemfibrozil AUC after 14.5 days of lopinavir-ritonavir (400mg/100mg) twice daily.|22 days per subject (approximately 1 year for entire study completion)|Fifteen healthy volunteers were enrolled in this protocol based on an a priori power analysis. All 15 subjects completed the protocol and results reported are those from all 15 participants.||ng*hr/mL||90% Confidence Interval|Geometric Mean
741571|NCT00474240|Secondary|Percent Change From Baseline of Other Lipids||After 8 weeks of study drug|Intent To Treat||Percent||Standard Deviation|Mean
741572|NCT00474240|Primary|Percent Change From Baseline in LDL-C at 8 Weeks||Atfer 8 weeks on study drug|Intent To Treat||Percent Change||Standard Deviation|Mean
741573|NCT00474383|Secondary|Shift From Baseline in Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score at Post-dose (Week 148)|The ECOG performance status score ranges from 0 to 5 where 0=fully active, perform all pre-disease activities without restriction; 1=restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature; 2=ambulatory, capable of self-care, unable to carry out any work activities, up and about more than (>) 50 percentage of waking hours; 3=capable of limited self-care, confined to bed or chair >50 percentage of waking hours; 4=completely disabled, not capable of any self-care, totally confined to bed or chair; and 5=dead.|Baseline until first documented disease progression or up to end of study (Week 148; assessed on Day 1 of each cycle)|The ITT population included all the participants who were enrolled into the study.||participants|||Number
741574|NCT00474383|Secondary|Overall Survival|Overall survival was defined as the interval from the date of the first dose of abiraterone acetate to the date of death.|Baseline until death, or end of study (Week 148)|The ITT population included all the participants who were enrolled into the study.||days||95% Confidence Interval|Median
741575|NCT00474383|Secondary|Progression Free Survival Time|Progression Free Survival was defined as the interval from the date of the first dose of abiraterone acetate to the date of death or date of progressive disease (PD) as assessed by RECIST criteria. PD was at least 20 percent increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Baseline until first documented disease progression or death or up to end of study (Week 148; assessed on Day 1 of each cycle)|The ITT population included all the participants who were enrolled into the study. Here 'N' (number of participants analyzed) signifies evaluable participants with measurable disease (the presence of at least one measurable lesion) at Baseline.||days||95% Confidence Interval|Median
741576|NCT00474383|Secondary|Duration of PSA Response|Duration of PSA response was the time between the date of first PSA response (greater than or equal to 50 percent decline from Baseline) and the date of PSA progression as defined by the PSAWG. PSA progression was defined as a 50 percent increase over the nadir PSA value, increase in the PSA level by at least 5 nanogram per milliliter (ng/mL), and confirmed by second consecutive measurement.|Baseline until first documented disease progression or up to end of study (Week 148; assessed on Days 1, 8 of Cycle 1, thereafter Day 1 of each Cycle)|The ITT population included all the participants who were enrolled into the study.||days||95% Confidence Interval|Median
741577|NCT00474383|Secondary|Time to PSA Progression|The time to PSA progression was the interval from the date of the first dose of abiraterone acetate to the date of PSA progression as defined by the PSAWG criteria. PSA progression was defined as a 50 percent increase over the nadir PSA value, increase in the PSA level by at least 5 nanogram per milliliter (ng/mL), and confirmed by second consecutive measurement.|Baseline until first documented disease progression or up to end of study (Week 148; assessed on Days 1, 8 of Cycle 1, thereafter Day 1 of each Cycle)|The ITT population included all the participants who were enrolled into the study.||days||95% Confidence Interval|Median
741578|NCT00474383|Secondary|Percentage of Participants With Confirmed Objective Tumor Response as Per Response Evaluation Criteria in Solid Tumors (RECIST)|The objective tumor response was defined as the percentage of participants achieving a complete (CR) or partial response (PR) on tumor response assessed as per RECIST. The CR was disappearance of all lesions. The PR was at least a 30 percent decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the Baseline sum LD.|Baseline until first documented disease progression or end of study visit (Week 148; assessed on Day 1 of Cycle 4, 7, 10, and thereafter Day 1 of each cycle)|The ITT population included all the participants who were enrolled into the study. Here 'N' (number of participants analyzed) signifies evaluable participants with measurable disease (the presence of at least one measurable lesion) at Baseline.||percentage of participants||95% Confidence Interval|Number
741579|NCT00474383|Secondary|Percentage of Participants With Confirmed Prostate Specific Antigen (PSA) Response|The PSA response was evaluated according to Prostate-Specific Antigen Working Group (PSAWG) criteria, which was, greater than or equal to 50 percent decrease in PSA from Baseline and confirmed by subsequent measurement at least 4 weeks later.|Baseline up to Week 12|The Intent-to-treat (ITT) population included all the participants who were enrolled into the study.||percentage of participants||95% Confidence Interval|Number
741580|NCT00474383|Primary|Percentage of Participants With Confirmed Prostate Specific Antigen (PSA) Response at Week 12|The PSA response was evaluated according to Prostate-Specific Antigen Working Group (PSAWG) criteria, which was, greater than or equal to 50 percent decrease in PSA from Baseline and confirmed by subsequent measurement at least 4 weeks later.|Baseline, Week 12|The Intent-to-treat (ITT) population included all the participants who were enrolled into the study.||percentage of participants||95% Confidence Interval|Number
741581|NCT00480324|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Up to 2 years of age|The analysis was performed on the Total Vaccinated cohort.||subjects|||Number
741582|NCT00480324|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited adverse event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|During the 31-day follow-up period after each dose|The analysis was performed on the Total Vaccinated cohort.||subjects|||Number
744258|NCT00508027|Other Pre-specified|Change in Plasma VCAM1 Levels|Change in plasma vascular cellular adhesion molecule-1 levels after treatment with simvastatin|Baseline, 21 days|||ng/mL||Standard Deviation|Mean
741584|NCT00480324|Secondary|Number of Subjects Seroconverted for Anti-rotavirus Immunoglobulin A (IgA) Antibodies|Seroconversion was defined as the appearance of anti-rotavirus immunoglobulin A antibody concentration ≥ 20 units (U)/milliliter (mL) in subjects initially (i.e. prior to the first dose of rotarix) seronegative.|2 months after Dose 2|The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity.||subjects|||Number
741585|NCT00480324|Secondary|Serum Anti-rotavirus Immunoglobulin A (IgA) Antibody Concentration|Anti-rotavirus immunoglobulin A antibody concentrations are given as geometric mean concentrations (GMCs). Arbitrary 'zero' values were set in the Placebo Group since the GMC was below the assay cut-off value (20 U/mL).|2 months after Dose 2|The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity.||Units per milliliter (U/mL)||95% Confidence Interval|Geometric Mean
741586|NCT00480324|Secondary|Number of Subjects Reporting Any Rotavirus (RV) Gatroenteritis (GE) and Severe RV GE Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains|"Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode.
Severe rotavirus gastroenteritis was defined as an episode of rotavirus gastroenteritis with score ≥ 11 on a 20-point scoring system (Vesikari scoring system)."|From Dose 1 up to 2 years of age|The analysis was performed on the Total Vaccinated cohort.||subjects|||Number
741587|NCT00480324|Secondary|Number of Subjects Hospitalized Due to Rotavirus (RV) Gastroenteritis (GE) Caused by the Circulating Wild-type RV Strains|Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode.|From 2 weeks after Dose 2 up to 2 years of age|The analysis was performed on the according-to-protocol (ATP) cohort for efficacy.||subjects|||Number
741588|NCT00480324|Secondary|Number of Subjects Reporting Any Rotavirus (RV) Gastroenteritis (GE) and Severe RV GE Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains of Non-G1 Types|"Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode.
Severe rotavirus gastroenteritis was defined as an episode of rotavirus gastroenteritis with score ≥ 11 on a 20-point scoring system (Vesikari scoring system)."|From 2 weeks after Dose 2 up to 2 years of age|The analysis was performed on the according-to-protocol (ATP) cohort for efficacy.||subjects|||Number
741589|NCT00480324|Secondary|Number of Subjects Reporting Any Rotavirus (RV) Gastroenteritis (GE) and Severe RV GE Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains of G1 Type|"Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode.
Severe RV GE was defined as an episode of rotavirus gastroenteritis with score ≥ 11 on a 20-point scoring system (Vesikari scoring system)."|From 2 weeks after Dose 2 up to 2 years of age|The analysis was performed on the according-to-protocol (ATP) cohort for efficacy.||subjects|||Number
741590|NCT00480324|Secondary|Number of Subjects Reporting Severe Rotavirus (RV) Gastroenteritis (GE) Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains|A subject was considered as reporting severe rotavirus gastroenteritis when the subject scored 11 or more on a 20-point scoring system (Vesikari scoring system).|From 2 weeks after Dose 2 up to 2 years of age|The analysis was performed on the according-to-protocol (ATP) cohort for efficacy.||subjects|||Number
741591|NCT00480324|Primary|Number of Subjects Reporting Any Rotavirus (RV) Gastroenteritis (GE) Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains|Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode.|From 2 weeks after Dose 2 up to 2 years of age|The analysis was performed on the according-to-protocol (ATP) cohort for efficacy.||subjects|||Number
741592|NCT00480493|Primary|Worry|Parent worry in managing child's care. Higher total scores (11 questions, minimum score is 11, maximum score is 44) indicate more parental worry|12 months|||units on a scale||Standard Deviation|Mean
741593|NCT00480493|Primary|Parent Concern|Parent concern in managing child with type 1 diabetes. Higher total scores (58 questions, minimum score is 58; maximum score is 255) means more worry with managing child's diabetes care.|12 months|||units on a scale||Standard Deviation|Mean
741594|NCT00480493|Primary|Maternal Confidence Scale|Maternal confidence in managing child with type 1 diabetes . Higher total scores (10 questions, minimum score of 0, maximum score of 50) mean a better outcome (greater maternal confidence)|12 months|All participants with data were analyzed||units on a scale||Standard Deviation|Mean
741595|NCT00480857|Secondary|The Number of Patients Alive|The number of patients alive at 4 years.|4 years|||Participants|||Count of Participants
741596|NCT00480857|Secondary|The Number of Patients That Experience Evidence of Local Recurrence|The number of patients that have local disease recurrence by imaging and clinical findings.|4 years|||Participants|||Count of Participants
741597|NCT00480857|Secondary|The Percentage of Patients That Experience at Least 1 Grade 1, 2, 3 and 4 Toxicities|"To determine the rates of toxicities among patients treated with concurrent weekly docetaxel (TAXOTERE) and salvage prostate bed radiation therapy.
G1 events are considered mild. G2 events are considered moderate G3 events are considered severe G4 events are considered life-threatening"|4 years|||percentage of patients|||Number
741598|NCT00480857|Secondary|Number of Patients That Achieve a Post-radiotherapy PSA Nadir of 0.1 ng/mL or Less|To determine the rates of complete biochemical response (as defined by achievement of a post-radiotherapy PSA nadir of 0.1 ng/mL or less) after concurrent weekly docetaxel (TAXOTERE) and salvage prostate bed radiation therapy.|4 years|||patients|||Number
741847|NCT00483262|Primary|Toxicity. Number of Patients With Specific Toxicities Are Reported.|Toxicity of CCI-779 (Temsirolimus) and bortezomib (Velcade) in patients with multiple myeloma.|10 months|Any patient who was treated was included in the analysis.||percentage of patients||95% Confidence Interval|Number
741599|NCT00480857|Primary|Percentage of Patients Alive Without Progression at 4 Years|The primary objective is to assess the 4-year progression free proportion of patients treated with concurrent weekly docetaxel (TAXOTERE) and salvage prostate bed radiation therapy among patients with biochemical recurrence after radical prostatectomy.|4 years|||percentage of patients||95% Confidence Interval|Number
741600|NCT00480987|Primary|Number of Participants With Objective Response|Objective response: Complete Response/Remission (CR) defined as a bone marrow with 5% or fewer blasts and peripheral blood count with an absolute neutrophil count of 10^9/Liters or more and platelet count of 100*10^9/Liters or more; Complete Response with Platelets/remission without platelet recovery (CRp) defined as a complete response except for a platelet less than 100*10^9/Liters and transfusion independent; and Partial Response/Remission defined as peripheral blood count recovery as for CR with decrease in marrow blasts >/= 50% and not more than 6-25% abnormal cells in the marrow.|After 2 months|Analysis was per protocol. All participants treated were analyzed.||Participants|||Number
741601|NCT00481065|Secondary|Geometric Mean Ratio After the Booster Vaccination Against the MF59-eH5N1 Influenza Vaccine Mixed Extemporaneously With the Seasonal eTIV_a Influenza Vaccine|For each vaccine group, the least squares GMRs were calculated for the HI and SRH results for each time point of the study, as well as the associated 95% confidence intervals. GMR was calculated over day 382 for all time points for the booster dose.|21 days after booster vaccination (day 403)|Full analysis set (FAS)||Ratio||95% Confidence Interval|Geometric Mean
741602|NCT00481065|Primary|Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain B)|For each vaccine group, the least squares GMRs were calculated for the haemagglutination inhibition (HI) results for each time point of the study, as well as the associated 95% confidence intervals. GMR was calculated over day 1.|21 days after second and third vaccinations (day 43 and day 403)|Full analysis set (FAS)||Ratio||95% Confidence Interval|Geometric Mean
741603|NCT00481065|Primary|Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain H3N1)|For each vaccine group, the least squares GMRs were calculated for the haemagglutination inhibition (HI) results for each time point of the study, as well as the associated 95% confidence intervals. GMR was calculated over day 1.|21 days after second and third vaccinations (day 43 and day 403)|Full analysis set (FAS)||Ratio||95% Confidence Interval|Geometric Mean
741604|NCT00481065|Secondary|Number of Subjects With Immunogenicity Results After the Booster Vaccination Against the MF59-eH5N1 Influenza Vaccine Mixed Extemporaneously With the Seasonal eTIV_a Influenza Vaccine|"Booster was given on day 382; seroconversion: negative pre-vaccination serum (HI titer <10, SRH area ≤ 4 mm^2)/positive post-vaccination titer (HI titer ≥10) or at least 50% increase in SRH area; Seroprotection is defined as a HI titer ≥40 and a SRH area ≥25 mm^2.
The number of subjects achieving seroconversion or significant increase and seroprotection were calculated at day 382."|21 days after booster vaccination (day 403)|Full analysis set (FAS)||Subjects|||Number
741605|NCT00481065|Primary|Geometric Mean Ratio After Two Doses of the Seasonal eTIV_a Influenza Vaccine (Strain H1N1)|For each vaccine group, the least squares GMRs were calculated for the haemagglutination inhibition (HI) results as well as the associated 95% confidence intervals. GMR was calculated over day 1.|21 days after second vaccination (day 43)|Full analysis set (FAS)||Ratio||95% Confidence Interval|Geometric Mean
741606|NCT00481065|Primary|Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain B)|"seroconversion (serocon.): negative pre-vaccination serum (HI titer <10, SRH area =<4 mm^2)/positive post-vaccination titer (HI titer =>10) or at least 50% increase in the SRH area.
Seroprotection is defined as a HI titer ≥40 and a SRH area ≥25 mm^2."|21 days after second and third vaccinations (day 43 and day 403)|The analysis was done on the full analysis set (FAS).||Subjects|||Number
741607|NCT00481065|Primary|Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H3N2)|"seroconversion (serocon.): negative pre-vaccination serum (HI titer <10, SRH area =<4 mm^2)/positive post-vaccination titer (HI titer =>10) or at least 50% increase in the SRH area.
Seroprotection is defined as a HI titer ≥40 and a SRH area ≥25 mm^2."|21 days after second and third vaccinations (day 43 and day 403)|The analysis was done on the full analysis set (FAS).||Subjects|||Number
741608|NCT00481065|Primary|Number of Subjects Who Responded to Two Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H1N1)|"seroconversion: negative pre-vaccination serum (HI titer <10, SRH area =<4 mm^2)/positive post-vaccination titer (HI titer =>10) or at least 50% increase in the SRH area.
Seroprotection is defined as a HI titer ≥40 and a SRH area ≥25 mm^2."|21 days after second vaccination (day 43)|The analysis was done on the full analysis set (FAS).||Subjects|||Number
741609|NCT00481065|Secondary|Number of Subjects Reporting Local and Systemic Reactions by Vaccination|The evaluate the safety of the administration of two or three vaccinations of MF59-eH5N1 influenza vaccine, either given sequentially, concomitantly or mixed extemporaneously with seasonal eTIV_a influenza vaccine.|21 days after second and third vaccinations (day 43 and day 403)|||Subjects|||Number
741610|NCT00481065|Primary|Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine|Geometric mean Ratio (GMR) was calculated for the haemagglutination inhibition (HI), microneutralization (MN) and single-radial haemolysis (SRH) result as well as the associated 95% confidence intervals. GMR was calculated as 21 days after second and third vaccinations over day 1.|21 days after second and third vaccinations (day 22 and day 43)|Full analysis set (FAS)||Ratio||95% Confidence Interval|Geometric Mean
741611|NCT00481065|Primary|Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine|"Seroconversion (serocon.) is defined as negative pre-vaccination serum (titer <10 for HI [Haemagglutination Inhibition], area ≤4 mm^2 for SRH [Single Radial Haemolysis]) / positive post-vaccination titer (titer ≥ 40 for HI, area ≥ 25 mm^2 for SRH).
Significant increase in antibody titer is defined as at least a fourfold increase from non-negative pre-vaccination serum (HI ≥ 10) or at least 50% increase in the SRH area.
Seroprotection is defined as a HI titer ≥40 and a SRH area ≥25 mm^2."|21 days after second and third vaccinations (day 43 and day 403)|The analysis was done on the full analysis set (FAS).||Subjects|||Number
741612|NCT00481078|Secondary|Overall Survival|Evaluated using the Kaplan-Meier method. Compared between arms using the log-rank test.|Up to 1 year|||Months||95% Confidence Interval|Median
741613|NCT00481078|Secondary|Progression-free Survival|Evaluated using the Kaplan-Meier method. Compared between arms using the log-rank test.|Up to 1 year|||Months||95% Confidence Interval|Median
748839|NCT00538642|Secondary|Cholesterol||Baseline|||mg/dL||Standard Deviation|Mean
741614|NCT00481078|Primary|Response Rate|"Each patient will be assigned one of the following categories: 1) complete response, 2) partial response, 3) stable disease, 4) progressive disease, 5) early death from malignant disease, 6) early death from toxicity, 7) early death because of other cause, or 9) unknown (not assessable, insufficient data).
Patients with confirmed CR or PR according to the RECIST criteria were considered to have responded to treatment."|Assessed every two cycles|||percentage of responding patients||95% Confidence Interval|Number
741615|NCT00481195|Secondary|The Number of Responders According to the Clinical Global Impression of Change – Bipolar Version (CGI BP) Measure of Depression at Week 8|"CGI-BP is a standardized, clinician-rated assessment which allows the clinician to rate the bipolar illness at various time points compared with baseline. At Screening and Baseline visits the physician rated the severity of the illness using 7 categories (1=normal through 7=very severely ill). At subsequent visits the clinician assessed the change in severity of the condition using 7 categories (1=very much improved through 7=very much worse). Subjects were considered responders if they had a rating of much improved or very much improved. The number of responders at Week 8 are presented."|Baseline and 8 weeks following the start of study drug administration|Full analysis set defined as subjects who were assessed with CGI-BP at baseline and at week 8||Participants|||Number
741616|NCT00481195|Secondary|The Number of Responders According to the Clinical Global Impression of Change – Bipolar Version (CGI BP) Measure of Depression at Week 6|"CGI-BP is a standardized, clinician-rated assessment which allows the clinician to rate the bipolar illness at various time points compared with baseline. At Screening and Baseline visits the physician rated the severity of the illness using 7 categories (1=normal through 7=very severely ill). At subsequent visits the clinician assessed the change in severity of the condition using 7 categories (1=very much improved through 7=very much worse). Subjects were considered responders if they had a rating of much improved or very much improved. The number of responders at Week 6 are presented."|Baseline and 6 weeks following the start of study drug administration|Full analysis set defined as subjects who were assessed by CGI-BP at baseline and at Week 6||Participants|||Number
741617|NCT00481195|Secondary|The Number of Responders According to the Clinical Global Impression of Change – Bipolar Version (CGI BP) Measure of Depression at Week 4|"CGI-BP is a standardized, clinician-rated assessment which allows the clinician to rate the bipolar illness at various time points compared with baseline. At Screening and Baseline visits the physician rated the severity of the illness using 7 categories (1=normal through 7=very severely ill). At subsequent visits the clinician assessed the change in severity of the condition using 7 categories (1=very much improved through 7=very much worse). Subjects were considered responders if they had a rating of much improved or very much improved. The number of responders at Week 4 are presented."|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects who were assessed with CGI-BP at baseline and at 4 weeks||Participants|||Number
741618|NCT00481195|Secondary|The Number of Responders According to the Clinical Global Impression of Change – Bipolar Version (CGI BP) Measure of Depression at Week 3|"CGI-BP is a standardized, clinician-rated assessment which allows the clinician to rate the bipolar illness at various time points compared with baseline. At Screening and Baseline visits the physician rated the severity of the illness using 7 categories (1=normal through 7=very severely ill). At subsequent visits the clinician assessed the change in severity of the condition using 7 categories (1=very much improved through 7=very much worse). Subjects were considered responders if they had a rating of much improved or very much improved. The number of responders at Week 3 are presented."|Baseline and 3 weeks following the start of study drug administration|Full analysis set defined as subjects who were assessed by CGI-BP at baseline and at 3 weeks||Participants|||Number
741619|NCT00481195|Secondary|The Number of Responders According to the Clinical Global Impression of Change – Bipolar Version (CGI BP) Measure of Depression at Week 2|"CGI-BP is a standardized, clinician-rated assessment which allows the clinician to rate the bipolar illness at various time points compared with baseline. At Screening and Baseline visits the physician rated the severity of the illness using 7 categories (1=normal through 7=very severely ill). At subsequent visits the clinician assessed the change in severity of the condition using 7 categories (1=very much improved through 7=very much worse). Subjects were considered responders if they had a rating of much improved or very much improved. The number of responders at Week 2 are presented."|Baseline and 2 weeks following the start of study drug administration|Full analysis set defined as subjects who were assessed by CGI-BP at baseline and week 2||Participants|||Number
741620|NCT00481195|Secondary|The Number of Responders According to the Clinical Global Impression of Change – Bipolar Version (CGI BP) Measure of Depression at Week 1|"CGI-BP is a standardized, clinician-rated assessment which allows the clinician to rate the bipolar illness at various time points compared with baseline. At Screening and Baseline visits the physician rated the severity of the illness using 7 categories (1=normal through 7=very severely ill). At subsequent visits the clinician assessed the change in severity of the condition using 7 categories (1=very much improved through 7=very much worse). Subjects were considered responders if they had a rating of much improved or very much improved. The number of responders at Week 1 are presented."|Baseline and 1 week following the start of study drug administration|Full analysis set defined as subjects who were assessed by CGI-BP at Baseline and Week 1||Participants|||Number
741621|NCT00481195|Secondary|The Number of Responders According to the Clinical Global Impression of Change – Bipolar Version (CGI BP) Measure of Depression at Endpoint (Week 8 or Last Observation After Baseline)|"CGI-BP is a standardized, clinician-rated assessment which allows the clinician to rate the bipolar illness at various time points compared with baseline. At Screening and Baseline visits the physician rated the severity of the illness using 7 categories (1=normal through 7=very severely ill). At subsequent visits the clinician assessed the change in severity of the condition using 7 categories (1=very much improved through 7=very much worse). Subjects were considered responders if they had a rating of much improved or very much improved. The number of responders at Endpoint are presented."|Baseline and 8 weeks (or last observation after baseline)|Full analysis set defined as subjects assessed by CGI-BP at Baseline and at least one observation after Baseline.||Participants|||Number
741771|NCT00482274|Secondary|Average Time for Participants to Develop PSA Recurrence (PSA > 0.2ng/ml)|Average time for participants to develop PSA recurrence (PSA > 0.2ng/ml). Due to the limited enrollment, this analysis was not completed.|Average days to develop recurrence from treatment start date amount applicable participants|Due to the limited enrollment, this analysis was not completed.|||||
748840|NCT00538642|Secondary|Triglycerides||4-5 months|||mg/dL||Standard Deviation|Mean
741622|NCT00481195|Secondary|Change From Baseline to 8 Weeks in the Hamilton Anxiety Scale (HAM A) Total Score|The HAM-A is a clinician-rated 14 item scale that provides an overall measure of global anxiety, including psychic (mental agitation and psychological distress) and somatic (physical complaints related to anxiety) symptoms. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0 - 56, where less than 17 indicates mild anxiety, 18 - 24 mild to moderate anxiety and 25-30 moderate to severe. The data presented here summarizes the change in HAM-A score from Baseline to 8 Weeks|Baseline and 8 weeks following the start of study drug administration|Full analysis set defined as subjects who completed the HAM-A at baseline and at 8 weeks||Units on a scale||Standard Error|Least Squares Mean
741623|NCT00481195|Secondary|Change From Baseline to 4 Weeks in the Hamilton Anxiety Scale (HAM A) Total Score|The HAM-A is a clinician-rated 14 item scale that provides an overall measure of global anxiety, including psychic (mental agitation and psychological distress) and somatic (physical complaints related to anxiety) symptoms. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0 - 56, where less than 17 indicates mild anxiety, 18 - 24 mild to moderate anxiety and 25-30 moderate to severe. The data presented here summarizes the change in HAM-A score from Baseline to 4 Weeks|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects who completed the HAM-A at baseline and at 4 weeks||Units on a scale||Standard Error|Least Squares Mean
741624|NCT00481195|Secondary|Change From Baseline to Endpoint (8 Weeks or Last Observation After Baseline) in Hamilton Anxiety Scale (HAM-A) Total Score|The HAM-A is a clinician-rated 14 item scale that provides an overall measure of global anxiety, including psychic (mental agitation and psychological distress) and somatic (physical complaints related to anxiety) symptoms. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0 - 56, where less than 17 indicates mild anxiety, 18 - 24 mild to moderate anxiety, 25-30 moderate to severe, >30 very severe. The data presented here summarizes the change in HAM-A score from Baseline to Endpoint (8 weeks or last observation after baseline).|baseline and 8 weeks (or last observation after baseline)|Full analysis set defined as subjects who completed the HAM-A at baseline and at least once after baseline||Units on a scale||Standard Error|Least Squares Mean
741625|NCT00481195|Secondary|Change From Baseline to Week 8 in the Quality of Life Enjoyment and Satisfaction Questionnaire – Short Form (Q-LES-Q-SF)|The Q-LES-Q-SF is an instrument designed to measure general activities of daily living. It is a patient-rated quality of life questionnaire and consists of 16 items, but only the first 14 are included in the total score. Each item is rated by the patient on a scale from 1 - 5 (1=very poor, 2=poor, 3=fair, 4=good, and 5=very good). The minimum score is 14 and the maximum score is 70, with lower scores indicating poorer quality of life. The data presented here summarizes the change in score from baseline to 8 weeks.|Baseline and 8 weeks following the start of study drug administration|Full analysis set defined as subjects who completed questionnaire at baseline and at 8 weeks||Units on a scale||Standard Error|Least Squares Mean
741626|NCT00481195|Secondary|Change From Baseline to Week 4 in the Quality of Life Enjoyment and Satisfaction Questionnaire – Short Form (Q-LES-Q-SF)|The Q-LES-Q-SF is an instrument designed to measure general activities of daily living. It is a patient-rated quality of life questionnaire and consists of 16 items, but only the first 14 are included in the total score. Each item is rated by the patient on a scale from 1 - 5 (1=very poor, 2=poor, 3=fair, 4=good, and 5=very good). The minimum score is 14 and the maximum score is 70, with lower scores indicating poorer quality of life. The data presented here summarizes the change in score from baseline to 4 weeks.|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects who completed the questionnaire at baseline and at 4 weeks.||Units on a scale||Standard Error|Least Squares Mean
741627|NCT00481195|Secondary|Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) in the Quality of Life Enjoyment and Satisfaction Questionnaire – Short Form (Q-LES-Q-SF)|The Q-LES-Q-SF is an instrument designed to measure general activities of daily living. It is a patient-rated quality of life questionnaire and consists of 16 items, but only the first 14 are included in the total score. Each item is rated by the patient on a scale from 1 - 5 (1=very poor, 2=poor, 3=fair, 4=good, and 5=very good). The minimum score is 14 and the maximum score is 70, with lower scores indicating poorer quality of life. The data presented here summarizes the change in score from baseline to endpoint (8 weeks or last observation after baseline).|Baseline and 8 weeks (or last observation after baseline)|Full analysis set defined as subjects who completed the questionnaire at baseline and at any appropriate time point after baseline||Units on a scale||Standard Error|Least Squares Mean
741628|NCT00481195|Secondary|Change From Baseline to Week 8 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)|The QIDS-SR16 is a 16-item rating scale of depressive symptoms completed by the patient at each visit. It is a shorter version of the IDS-C30 that is completed by the patient rather than the examiner. The total score ranges from 0 to 27 (higher score signifies more severe depression) and is obtained by adding the scores for each of the 9 depression symptom domains of the DSM IV. The data presented here summarizes the change in QIDS-SR16 from Baseline to Week 8.|Baseline and 8 weeks following the start of study drug administration|Full analysis set defined as subjects who completed the QIDS-SR16 at baseline and at 8 weeks||Units on a scale||Standard Error|Least Squares Mean
741629|NCT00481195|Secondary|Change From Baseline to Week 6 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)|The QIDS-SR16 is a 16-item rating scale of depressive symptoms completed by the patient at each visit. It is a shorter version of the IDS-C30 that is completed by the patient rather than the examiner. The total score ranges from 0 to 27 (higher score signifies more severe depression) and is obtained by adding the scores for each of the 9 depression symptom domains of the DSM IV. The data presented here summarizes the change in QIDS-SR16 from Baseline to Week 6.|Baseline and 6 weeks following the start of study drug administration|Full analysis set defined as subjects who completed the QIDS-SR16 at baseline and at 6 weeks||Units on a scale||Standard Error|Least Squares Mean
741630|NCT00481195|Secondary|Change From Baseline to Week 4 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)|The QIDS-SR16 is a 16-item rating scale of depressive symptoms completed by the patient at each visit. It is a shorter version of the IDS-C30 that is completed by the patient rather than the examiner. The total score ranges from 0 to 27 (higher score signifies more severe depression) and is obtained by adding the scores for each of the 9 depression symptom domains of the DSM IV. The data presented here summarizes the change in QIDS-SR16 from Baseline to Week 4.|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects who completed the QIDS-SR16 at baseline and at 4 weeks||Units on a scale||Standard Error|Least Squares Mean
741631|NCT00481195|Secondary|Change From Baseline to Week 3 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)|The QIDS-SR16 is a 16-item rating scale of depressive symptoms completed by the patient at each visit. It is a shorter version of the IDS-C30 that is completed by the patient rather than the examiner. The total score ranges from 0 to 27 (higher score signifies more severe depression) and is obtained by adding the scores for each of the 9 depression symptom domains of the DSM IV. The data presented here summarizes the change in QIDS-SR16 from Baseline to Week 3.|Baseline and 3 weeks following the start of study drug administration|Full analysis set defined as subjects who completed the QIDS-SR16 at baseline and at week 3||Units on a scale||Standard Error|Least Squares Mean
741632|NCT00481195|Secondary|Change From Baseline to Week 2 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)|The QIDS-SR16 is a 16-item rating scale of depressive symptoms completed by the patient at each visit. It is a shorter version of the IDS-C30 that is completed by the patient rather than the examiner. The total score ranges from 0 to 27 (higher score signifies more severe depression) and is obtained by adding the scores for each of the 9 depression symptom domains of the DSM IV. The data presented here summarizes the change in QIDS-SR16 from Baseline to Week 2|Baseline and 2 weeks following the start of study drug administration|Full analysis set defined as subjects who completed the QIDS-SR16 at baseline and at 2 weeks||Units on a scale||Standard Error|Least Squares Mean
741633|NCT00481195|Secondary|Change From Baseline to Week 1 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)|The QIDS-SR16 is a 16-item rating scale of depressive symptoms completed by the patient at each visit. It is a shorter version of the IDS-C30 that is completed by the patient rather than the examiner. The total score ranges from 0 to 27 (higher score signifies more severe depression) and is obtained by adding the scores for each of the 9 depression symptom domains of the DSM IV. The data presented here summarizes the change in QIDS-SR16 from Baseline to Week 1|Baseline and 1 week following the start of study drug administration|Full analysis set defined as subjects who completed the QIDS-SR16 at baseline and at 1 week||Units on a scale||Standard Error|Least Squares Mean
741634|NCT00481195|Secondary|Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)|The QIDS-SR16 is a 16-item rating scale of depressive symptoms completed by the patient at each visit. It is a shorter version of the IDS-C30 that is completed by the patient rather than the examiner. The total score ranges from 0 to 27 (higher score signifies more severe depression) and is obtained by adding the scores for each of the 9 depression symptom domains of the DSM IV. The data presented here summarizes the change in QIDS-SR16 from Baseline to Endpoint (Week 8 or last observation after baseline).|Baseline and 8 weeks (or last observation after baseline)|Full analysis set defined as subjects who completed the QIDS-SR16 at baseline and at least one observation after baseline.||Units on a scale||Standard Error|Least Squares Mean
741635|NCT00481195|Secondary|Change From Baseline to Week 8 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|The MADRS is a 10-item scale to evaluate the overall severity of a patient's depressive symptoms, that is completed by the physician. The rating scale makes use of both observational clues as to the subject's level of depression (eg. apparent sadness) and verbal indicators of depression expressed by the patient. Each of the 10 items is graded on a 6-point scale with anchors at 2 point intervals. Total scores range from 0 to 60, with the higher number indicating more severe symptoms of depression. Here we present data summarizing the difference in MADRS score from Baseline to Week 8.|Baseline and 8 weeks following the start of study drug administration|Full analysis set defined as subjects who were assessed by MADRS at both baseline and at Week 8||Units on a scale||Standard Error|Least Squares Mean
741636|NCT00481195|Secondary|Change From Baseline to Week 4 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|The MADRS is a 10-item scale to evaluate the overall severity of a patient's depressive symptoms, that is completed by the physician. The rating scale makes use of both observational clues as to the subject's level of depression (eg. apparent sadness) and verbal indicators of depression expressed by the patient. Each of the 10 items is graded on a 6-point scale with anchors at 2 point intervals. Total scores range from 0 to 60, with the higher number indicating more severe symptoms of depression. Here we present data summarizing the difference in MADRS score from Baseline to Week 4.|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects who were assessed by MADRS at both baseline and at Week 4||Units on a scale||Standard Error|Least Squares Mean
741637|NCT00481195|Secondary|Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|The MADRS is a 10-item scale to evaluate the overall severity of a patient's depressive symptoms, that is completed by the physician. The rating scale makes use of both observational clues as to the subject's level of depression (eg. apparent sadness) and verbal indicators of depression expressed by the patient. Each of the 10 items is graded on a 6-point scale with anchors at 2 point intervals. Total scores range from 0 to 60, with the higher number indicating more severe symptoms of depression. Here we present data summarizing the change in MADRS from Baseline to Endpoint.|Baseline and Endpoint (8 weeks following the start of study drug administration or last observation after baseline)|Full analysis set defined as subjects who had both a baseline observation and at least one observation after baseline||Units on a scale||Standard Error|Least Squares Mean
741638|NCT00481195|Secondary|Change From Baseline to Week 8 on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) - Item 4|The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient’s depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. Item 4 assesses hypersomnia on a scale from 0 (sleeps no longer than 7-8 hours a night) to 3 (sleeps longer than 12 hours in 24 hour period). The data presented here summarizes the change from baseline to week 8 in the score of Item 4 assessing hypersomnia.|Baseline and 8 weeks following the start of study drug administration|Full analysis set defined as subjects who were assessed with IDS-C30 at baseline and at week 8||Units on a scale||Standard Error|Least Squares Mean
741672|NCT00481507|Primary|Rate of Diarrhea by Parental Report|The primary outcome was the rate of diarrhea during the 14-day follow-up period in children receiving antibiotics.|14 days|Prior estimates of the sample size showed that 62 per group would have 80% power for detecting a difference of 20% in the rates of diarrhea. This was based on the placebo group having a 10% (which is consistent with published literature) rate of diarrhea. Analysis performed used the intention to treat and no imputation was required.||events/participants at risk|||Number
741639|NCT00481195|Secondary|Change From Baseline to Week 4 on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) - Item 4|The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient’s depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. Item 4 assesses hypersomnia on a scale from 0 (sleeps no longer than 7-8 hours a night) to 3 (sleeps longer than 12 hours in 24 hour period). The data presented here summarizes the change from baseline to week 4 in the score of Item 4 assessing hypersomnia.|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects assessed with IDS-C30 at baseline and at week 4||Units on a scale||Standard Error|Least Squares Mean
741640|NCT00481195|Secondary|Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) - Item 4|The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient’s depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. Item 4 assesses hypersomnia on a scale from 0 (sleeps no longer than 7-8 hours a night) to 3 (sleeps longer than 12 hours in 24 hour period). The data presented here summarizes the change from baseline to Endpoint in the score of Item 4 assessing hypersomnia.|Baseline and 8 weeks (or last observation after baseline)|Full analysis set defined as subjects assessed with IDS-C30 at baseline and at least one observation after baseline||Units on a scale||Standard Error|Least Squares Mean
741641|NCT00481195|Secondary|Change From Baseline to Week 8 on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) Combination of Items 1-3|The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient’s depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. Items 1 - 3 assess sleep onset insomnia, mid-nocturnal insomnia, and early morning insomnia respectively each on a 0 - 3 scale. The data presented here summarizes the change from baseline to week 8 in the combined score of these three items assessing insomnia.|Baseline and 8 weeks following the start of study drug administration|Full analysis set defined as subjects who were assessed with IDS-C30 at baseline and at week 8||Units on a scale||Standard Error|Least Squares Mean
741642|NCT00481195|Secondary|Change From Baseline to Week 4 on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) Combination of Items 1-3|The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient’s depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. Items 1 - 3 assess sleep onset insomnia, mid-nocturnal insomnia, and early morning insomnia respectively each on a 0 - 3 scale. The data presented here summarizes the change from baseline to week 4 in the combined score of these three items assessing insomnia.|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects who were assessed by IDS C30 at baseline and Week 4||Units on a scale||Standard Error|Least Squares Mean
741643|NCT00481195|Secondary|Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) Combination of Items 1-3|The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient’s depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. Items 1 - 3 assess sleep onset insomnia, mid-nocturnal insomnia, and early morning insomnia respectively each on a 0 - 3 scale. The data presented here summarizes the change from baseline to Endpoint in the combined score of these three items assessing insomnia.|Baseline and 8 weeks (or last observation after baseline)|Full analysis set defined as subjects who were assessed by IDS-C30 at baseline and at least one observation after baseline||Units on a scale||Standard Error|Least Squares Mean
741644|NCT00481195|Secondary|"Number of Patients Achieving Sustained Response at Endpoint According to the 30-item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)"|"The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient’s depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data here summarizes the number of subjects in each treatment group who achieved a sustained response (> 50% decrease from baseline in total score that persisted over the four week period between Week 4 and Week 8)."|Baseline, 4 and 8 weeks following start of study drug administration (or last observation after baseline)|Full analysis set defined as subjects who were assessed by IDS-C30 at baseline, and at least one observation after baseline||Participants|||Number
741645|NCT00481195|Secondary|"Number of Patients Achieving Sustained Remission at Endpoint According to the 30-item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)"|"The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient’s depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data here summarizes the number of subjects in each treatment group who achieved a sustained remission (total score <= 11 that persists over the four week period from Week 4 to Week 8)."|Baseline, 4 and 8 weeks following start of study drug administration (or last observation after baseline)|Full analysis set defined as subjects who were assessed by IDS-C30 at baseline, and at least one observation after baseline||Participants|||Number
741646|NCT00481195|Secondary|"Number of Patients Achieving Response at Endpoint According to the 30-item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)"|"The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient’s depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data here summarizes the number of subjects in each treatment group who achieved a response (> 50% decrease from baseline in total score)."|Baseline, 4 and 8 weeks following start of study drug administration (or last observation after baseline)|Full analysis set defined as subjects who were assessed by IDS-C30 at baseline, and at least one observation after baseline||Participants|||Number
741647|NCT00481195|Secondary|Number of Patients Achieving Remission at Endpoint According to the 30-item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)|The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient’s depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data here summarizes the number of subjects in each treatment group who achieved a remission (total score <=11).|Baseline, 4 and 8 weeks following start of study drug administration (or last observation after baseline)|Full analysis set defined as subjects who had completed IDS-C30 at baseline and at least one observation after baseline||Participants|||Number
741648|NCT00481195|Secondary|The Mean Change From Baseline to Week 8 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)|The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient’s depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data presented here summarizes the change from baseline to Week 8 in the total score of the IDS-C30.|Baseline and 8 weeks following the start of study drug administration|Full analysis set defined as subjects who were assessed at baseline and at 8 weeks with the IDS-C30.||Units on a scale||Standard Error|Least Squares Mean
741649|NCT00481195|Secondary|The Mean Change From Baseline to Week 6 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)|The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient’s depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data presented here summarizes the change from baseline to Week 6 in the total score of the IDS-C30.|Baseline and 6 weeks following the start of study drug administration|Full analysis set defined as subjects who were assessed with the IDS-C30 at baseline and at 6 weeks||Units on a scale||Standard Error|Least Squares Mean
741650|NCT00481195|Secondary|The Mean Change From Baseline to Week 4 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)|The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient’s depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data presented here summarizes the change from baseline to Week 4 in the total score of the IDS-C30.|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects who were assessed with the IDS-C30 at baseline and at 4 weeks||Units on a scale||Standard Error|Least Squares Mean
741651|NCT00481195|Secondary|The Mean Change From Baseline to Week 3 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)|The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient’s depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data presented here summarizes the change from baseline to Week 3 in the total score of the IDS-C30.|Baseline and 3 weeks following the start of study drug administration|Full analysis set defined as subjects who were assessed with the IDS-C30 at baseline and at 3 weeks||Units on a scale||Standard Error|Least Squares Mean
741652|NCT00481195|Secondary|The Mean Change From Baseline to Week 2 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)|The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient’s depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data presented here summarizes the change from baseline to Week 2 in the total score of the IDS-C30.|Baseline and 2 weeks following the start of study drug administration|Full analysis set defined as subjects who were assessed with the IDS-C30 at baseline and at 2 weeks||Units on a scale||Standard Error|Least Squares Mean
741653|NCT00481195|Secondary|The Mean Change From Baseline to Week 1 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)|The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient’s depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data presented here summarizes the change from baseline to Week 1 in the total score of the IDS-C30.|Baseline and 1 week following the start of study drug administration|Full analysis set defined as subjects who were assessed with the IDS-C30 at both baseline and at week 1 after start of study drug administration||Units on a scale||Standard Error|Least Squares Mean
741654|NCT00481195|Primary|The Mean Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)|The IDS C30 is a standardized 30 item, clinician rated scale to assess the severity of a patient’s depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data presented here summarizes the change from baseline to Endpoint (either week 8 or the last observation after baseline) in the total score of the IDS-C30.|Baseline and 8 weeks from start of study drug administration (or last observation after baseline)|Full analysis set defined as subjects who were assessed with the IDS-C30 at both baseline and at least one time point after baseline||Units on a scale||Standard Error|Least Squares Mean
741673|NCT00481676|Secondary|Investigator’s Global Assessment of the Patient’s Chronic Urticaria Symptoms|The investigator made a global assessment of the patient’s chronic urticaria symptoms on a 4-point Likert scale (none, mild, moderate, severe) at Baseline and again at the end of the study. The number of patients in each category is reported.|At Baseline and at the end of the study (Week 24)|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline assessment of the primary efficacy variable.||Participants|||Number
741848|NCT00483327|Secondary|Number of Women Who Became Pregnant||up to 3 years after the treatment for each patient|Only 7 participants in the trial pursued pregnancy.||participants|||Number
741849|NCT00483327|Secondary|Duration of Response|For each patient, assessed every 12 weeks during treatment and every 6 months during follow-up.|up to 4 years||09/2017||||
741655|NCT00481247|Other Pre-specified|Number of Participants With Grade 3/4 Abnormalities in On-study Laboratory Test Results|ULN=upper limit of normal. Grade 3=Severe AE; Grade 4=Life-threatening or disabling AE. Absolute neutrophil count: Grade 3 <1000-500/mm^3; Grade 4 <500/mm^3. Hemoglobin: Grade 3 <8.0-6.5 g/dL; Grade 4 <6.5 g/dL. Platelets: Grade 3 <50,000-25,000/mm^3; Grade 4 <25,000/mm^3. ALT/AST: Grade 3 >5.0-20*ULN; Grade 4 >20*ULN. Total bilirubin: Grade 3 >3-10*ULN; Grade 4 >10*ULN. Sample normal ranges (may vary by institution): ALT, Female: 7-30 U/L, Male: 10-55 U/L; AST, Female: 9-25 U/L, Male10-40 U/L; Total bilirubin: 0.0-1.0 mg/dL. Creatinine: Grade 3 >3.0–6.0*ULN; Grade 4 >6.0*ULN. Phosphate: Grade 3 <2.0–1.0 mg/dL; Grade 4 <1.0 mg/dL. Calcium: Grade 3 <7.0–6.0 mg/dL; Grade 4 <6.0 mg/dL. Potassium: Grade 3 <3.0–2.5 mmol/L; Grade 4 <2.5 mmol/L.|From date of last person, first visit to date of last person, last visit (approximately 8 years)|Participants with laboratory assessments||Participants|||Number
741656|NCT00481247|Other Pre-specified|Number of Participants With Adverse Events (AEs), Drug-related AEs, Drug-related Serious Adverse Events (SAEs), Drug-related AEs Leading to Discontinuation, and All Deaths|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.|From date of last person, first visit to date of last person, last visit (approximately 8 years)|All treated participants||Participants|||Number
741657|NCT00481247|Secondary|Percentage of Participants With Overall Survival (OS)|OS was defined as the time from randomization to the date of death. If the participant had not died, survival was censored on last date the participant was known to be alive.|Participants were followed-up for at least 5 years|All randomized participants||Percentage of participants|||Number
741658|NCT00481247|Secondary|Percentage of Participants With Progression-free Survival (PFS)|PFS was defined as the time from randomization until progression (any progression/death within 30 days of last dosing date, or between 30-60 days of last dosing prior to start of secondary therapy). Those who did not progress/die or who progressed/died after 60 days of last dose were censored at last on-study hematologic/cytogenetic assessment; those with progression/death 30-60 days of last dosing date and after start date of secondary therapy censored at last on-study hematologic/cytogenetic assessment prior to start of secondary therapy; those who had not received study treatment censored on date randomized.|Participants were followed-up for at least 5 years|All randomized participants||Percentage of participants|||Number
741659|NCT00481247|Secondary|Time to Major Molecular Response (MMR) Overall|The time to MMR for all randomized participants is defined as the time from randomization date until measurement criteria are first met for MMR. The time to MMR analysis censors nonresponders who do not progress at their last molecular assessments and nonresponders who progress at the maximum time of all randomized participants.|Day 1 to 5 years|All participants who received treatment and achieved MMR||Months||95% Confidence Interval|Median
741660|NCT00481247|Secondary|Time to Confirmed Complete Cytogenic Response (cCCyR) Overall|The time to cCCyR for all randomized participants is defined as the time from the randomization date until criteria are first met for complete cytogenic response (provided it is confirmed later). The time to cCCyR analysis censors nonresponders who do not progress at their last cytogenetic assessments and nonresponders who progress at the maximum time of all randomized participants.|Day 1 to 5 years|All randomized participants who achieved cCCyR||Months||95% Confidence Interval|Median
741661|NCT00481247|Secondary|Percentage of Participants With Major Molecular Response (MMR) at Any Time|Molecular response was assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction. MMR is defined as a ratio BCR-ABL/ABL ≤0.1% on the international scale (ie, at least 3 log reduction from a standardized baseline value).|Planned total follow-up duration of 5 years|All randomized participants||Percentage of participants|||Number
741662|NCT00481247|Secondary|Percentage of Participants Remaining in Confirmed Complete Cytogenetic Response (cCCyR)|"Cytogenetic response (CyR) is based on the prevalence of Philadelphia positive (Ph+) cells in metaphase from bone marrow (BM) sample. (Ideally, 25 metaphases but at least 20 metaphases from a BM sample were evaluated). Complete Cytogenetic Response (CCyR)=0% Ph+ cells in metaphase in BM. A cCCyR=those in which all measurements up to at least 28 days after the initial response show an equivalent or better CCyR.
Percentage of participants in cCCyR at years 2, 3, 4 and 5 was computed for all randomized participants who achieved cCCyR as measured from the time of first confirmation until the date of progression or death. Participants with cCCyR who neither progress nor die are censored on the date of their last cytogenetic assessment. Participants without cCCyR are considered to have progressed on Day 1."|Years 2, 3, 4 and 5|All randomized participants who achieved cCCyR||percentage of participants||95% Confidence Interval|Number
741663|NCT00481247|Primary|Number of Participants With Best Confirmed Complete Cytogenetic Response (cCCyR) Within 12 Months|Cytogenetic response (CyR) is based on the prevalence of Philadelphia positive (Ph+) cells in metaphase from bone marrow (BM) sample. (Ideally, 25 metaphases but at least 20 metaphases from a BM sample were evaluated). Complete Cytogenetic Response (CCyR)=0% Ph+ cells in metaphase in BM. A cCCyR=those in which all measurements up to at least 28 days after the initial response show an equivalent or better CCyR.|Pretreatment, every 3 months up to 12 months|All randomized participants||Participants|||Number
741664|NCT00481351|Secondary|High Density Lipoprotein||12 week|||mg/dl||Standard Deviation|Mean
741665|NCT00481351|Secondary|Total Cholesterol||12 week|||mg/dl||Standard Deviation|Mean
741666|NCT00481351|Secondary|CPK||12 week|||mg/dl||Standard Deviation|Mean
741667|NCT00481351|Secondary|Alanine Aminotransferase||12 weeks|||mg/dl||Standard Deviation|Mean
741668|NCT00481351|Primary|Low Density Lipoprotein||12week|||mg/dl||Standard Deviation|Mean
741669|NCT00481351|Secondary|Triglyceride Fractional Clearance Rate||6week||11/2010||||
741670|NCT00481351|Primary|Cholesteryl Ester Fractional Clearance Rate||6 weeks||07/2011||||
741671|NCT00481507|Secondary|Absences From Daycare or School Owing to Illness, Missed Parental Work Owing to the Child Being Ill, Vomiting, Stomach Pain, Constipation, Runny Nose, Cough, Earaches, Fever, Irritability, Lethargy, and Loose Stools.||14 days||||||
743540|NCT00486278|Secondary|Haematology: Haemoglobin||screening visit, pre-dose and 12 hours after dosing|Safety analysis set includes all subjects who received at least one dose of the investigational product.||g/dL||Standard Deviation|Mean
741674|NCT00481676|Secondary|Patient’s Global Assessment of Their Chronic Urticaria Symptoms|Patients made a global assessment of their chronic urticaria symptoms on a 4-point Likert scale (none, mild moderate, severe) at Baseline and again at the end of the study. The number of patients in each category is reported.|At Baseline and at the end of the study (Week 24)|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline assessment of the primary efficacy variable.||Participants|||Number
741675|NCT00481676|Secondary|Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24)|The CU-Q2oL (German version) is a questionnaire that measures the relative burden of chronic urticaria on subjective well-being. It has 23 questions in 3 domains (symptoms, general impairment, difficulties and problems due to urticaria). Patients are asked to respond how much they are troubled by each problem on a 5-point Likert scale (1=not at all to 5=very much). Each domain and the overall (total) scores are normalized to a scale of 1 to 100. A higher score indicates lower QoL. A negative change score (Week 24 score minus Baseline score) indicates improvement.|Baseline to the end of the study (Week 24)|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline assessment of the primary efficacy variable.||Units on a scale||Standard Deviation|Mean
741676|NCT00481676|Secondary|Change in the Skindex Score From Baseline to the End of the Study (Week 24)|Skindex is a 30-item questionnaire with 3 scores (functioning, emotions,symptoms) and a composite score (average scale score) that assesses the effects of skin disease on patients’ quality of life (QoL). Item responses are standardized on a scale from 0 to 100. The mean of all 61 items was calculated. A higher score indicates a lower QoL. A negative change score (Week 24 score minus Baseline score) indicates improvement.|Baseline to the end of the study (Week 24)|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline assessment of the primary efficacy variable.||Units on a scale||Standard Deviation|Mean
741677|NCT00481676|Secondary|Change in the Dermatology Life Quality Index (DLQI) Score From Baseline to the End of the Study (Week 24)|The DLQI is a dermatology-specific quality of life (QoL) questionnaire designed for use in patients over 16 years of age. Patients are asked to respond to each of 10 questions on a 4-point Likert scale in regard to how much their skin problem has affected their life over the last week (0=not at all, 1=a little, 2=a lot, 3=very much). The overall (total) DLQI score (range=0 to 30) is calculated by summing the scores of all 10 questions. The higher the score, the more QoL is impaired. A negative change score (Week 24 score minus Baseline score) indicates improvement.|Baseline to the end of the study (Week 24)|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline assessment of the primary efficacy variable.||Units on a scale||Standard Deviation|Mean
741678|NCT00481676|Secondary|Use of Concomitant and Rescue Medications|Data was collected from the patients' diaries about the number of clemastine and loratadine pills taken during the last 7 days of each month of the study.|At Weeks 4, 8, 12, 16, 20, and 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline assessment of the primary efficacy variable.||Pills||Standard Deviation|Mean
741679|NCT00481676|Secondary|Standardized (With Respect to Length of Time) Area Under the Curve (AUC) for the Urticaria Activity Score (UAS) From Baseline to the End of the Study (Week 24)|The UAS is a composite diary-recorded score with numeric severity ratings (0=none to 3=intense) for the number of wheals per 24 hours and the intensity of the pruritus. The total daily score (sum of the wheal and pruritus scores) ranges from 0 to 6. A higher score indicates worse disease. AUC was calculated from daily UASs where no urticaria medication was taken using the trapezoidal rule. The standardized AUC UAS was calculated as the sum of trapezoids divided by the length of time.|Baseline to the end of the study (Week 24)|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline assessment of the primary efficacy variable.||Units on a scale||Standard Deviation|Mean
741680|NCT00481676|Secondary|Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study|Patients kept a daily diary of the number of wheals and erythema and the severity of pruritus and angioedemas during the study.|At the end of the study (Week 24)|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline assessment of the primary efficacy variable.||Participants|||Number
741681|NCT00481676|Primary|Change in the Weekly Urticaria Activity Score (UAS7) From Baseline to the End of the Study (Week 24)|The UAS is a composite diary-recorded score with numeric severity ratings (0=none to 3=intense) for the number of wheals per 24 hours and the intensity of the pruritus. The total daily score (sum of the wheal and pruritus scores) ranges from 0 to 6. Because of variations in chronic urticaria disease intensity, assessment of disease activity was based on a weekly (7 days) UAS score called UAS7, that is, the sum of the daily UASs, ranging from 0 to 42 per week. A higher score indicates worse disease. A negative change score (Week 24 score minus Baseline score) indicates improvement.|Baseline to end of the study (Week 24)|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline assessment of the primary efficacy variable.||Units on a scale||Standard Deviation|Mean
741682|NCT00481767|Secondary|Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters Assessed|Parameters assessed were: Alanine amino-transferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), hematocrit (HC), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC). Number of subjects were separated with respect to their results at pre-vaccination, i.e. whether their results were in, above or below the normal range. N for each category at pre-vaccination noted in category title. For each parameter and for each range it was assessed whether the values of the subjects were in, above or below the normal range.|At Month 12|The analysis was performed on the Total Vaccinated cohort on Tanzanian subjects with available results.||subjects|||Number
741694|NCT00481767|Primary|Number of Seroconverted Subjects for Anti-human Papillomavirus (HPV)-16 and 18 Antibodies|"A seroconverted subject was a subject with antibody titers below 8 or 7 Enzyme-linked Immunosorbent Assay Units per milliliter (EL.U/mL) for anti-HPV-16 and 18, respectively, before vaccination and antibody titers >= 8 or 7 EL.U/mL for anti-HPV-16 and 18, respectively, after vaccination.
The groups were stratified by age for the analysis. The age strata were 10-14 years and 15-25 years."|At Month 7|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity on subjects with available results.||subjects|||Number
741683|NCT00481767|Secondary|Number of Senegalese Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters Assessed|Parameters assessed were: Alanine amino-transferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), hematocrit (HC), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC). Number of subjects were separated with respect to their results at pre-vaccination, i.e. whether their results were in, above or below the normal range. N for each category at pre-vaccination noted in category title. For each parameter and for each range it was assessed whether the values of the subjects were in, above or below the normal range.|At Month 12|The analysis was performed on the Total Vaccinated cohort on Senegalese subjects with available results.||subjects|||Number
741684|NCT00481767|Secondary|Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters Assessed|Parameters assessed were: Alanine amino-transferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), hematocrit (HC), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC). Number of subjects were separated with respect to their results at pre-vaccination, i.e. whether their results were in, above or below the normal range. N for each category at pre-vaccination noted in category title. For each parameter and for each range it was assessed whether the values of the subjects were in, above or below the normal range.|At Month 7|The analysis was performed on the Total Vaccinated cohort on Tanzanian subjects with available results.||subjects|||Number
741685|NCT00481767|Secondary|Number of Senegalese Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters Assessed|"Parameters assessed were:
Alanine amino-transferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), hematocrit (HC), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC).
Number of subjects were separated with respect to their results at pre-vaccination, i.e. whether their results were in, above or below the normal range. N for each category at pre-vaccination noted in category title.
For each parameter and for each range it was assessed whether the values of the subjects were in, above or below the normal range."|At Month 7|The analysis was performed on the Total Vaccinated cohort on Senegalese subjects with available results.||subjects|||Number
741686|NCT00481767|Secondary|Number of Subjects With Pregnancies and Their Outcomes|Pregnancy outcomes were ectopic pregnancy, elective termination no apparent congenital anomaly, live infant no apparent congenital anomaly, premature live infant no apparent congenital anomaly, lost to follow-up and spontaneous abortion no apparent congenital anomaly.|Up to Month 12|The analysis was performed on the Total Vaccinated cohort on pregnant subjects.||subjects|||Number
741687|NCT00481767|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Up to Month 7 and up to Month 12|The analysis was performed on the Total Vaccinated cohort.||subjects|||Number
741688|NCT00481767|Secondary|Number of Subjects With New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs)|NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. MSC include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury|Up to Month 7 and from Month 7 up to Month 12|The analysis was performed on the Total Vaccinated cohort on subjects with available results.||subjects|||Number
741689|NCT00481767|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|"Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Any= any unsolicited AE regardless of intensity and relationship to vaccination.
Grade 3= an unsolicited AE that prevented normal everyday activity Related= unsolicited AE assessed by the investigator as causally related to the study vaccination."|Within 30 days (Day 0-29) after any vaccination|The analysis was performed on the Total Vaccinated cohort.||subjects|||Number
741690|NCT00481767|Secondary|Number of Subjects With Solicited Local and General Symptoms|Solicited local symptoms were pain and swelling at the injection site. Solicited general symptoms were arthralgia, fatigue, fever (defined as axillary temperature >= 37.5 degrees Celsius), gastrointestinal symptoms, headache, myalgia, rash and urticaria.|Within 7 days (Day 0-6) after vaccination|The analysis was performed on the Total Vaccinated cohort.||subjects|||Number
741691|NCT00481767|Secondary|GMTs for Anti-HPV-16 and Anti-HPV-18 Antibodies|"Titers were expressed as GMTs in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
The groups were stratified by age for the analysis. The age strata were 10-14 years and 15-25 years."|At Month 2 and Month 12|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity on subjects with available results.||EL.U/mL||95% Confidence Interval|Geometric Mean
741692|NCT00481767|Secondary|Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies|"A seroconverted subject was a subject with antibody titers below 8 or 7 Enzyme-linked Immunosorbent Assay Units per milliliter (EL.U/mL) for anti-HPV-16 and 18, respectively, before vaccination and antibody titers >= 8 or 7 EL.U/mL for anti-HPV-16 and 18, respectively, after vaccination.
The groups were stratified by age for the analysis. The age strata were 10-14 years and 15-25 years."|At Month 2 and Month 12|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity on subjects with available results.||subjects|||Number
741693|NCT00481767|Primary|Geometric Mean Titers (GMTs) of Anti-HPV-16 and Anti-HPV-18 Antibodies|"Titers were expressed as GMTs in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
The groups were stratified by age for the analysis. The age strata were 10-14 years and 15-25 years."|At Month 7|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity on subjects with available results.||EL.U/mL||95% Confidence Interval|Geometric Mean
741695|NCT00481845|Secondary|Pathologic Complete Response||1 year|CR+PR||Participants|||Count of Participants
741772|NCT00482274|Primary|Number of Participants With a Complete Response as Measured by Serum PSA Less Than 0.2 ng/ml|Complete response rate, as measured by PSA and defined as a PSA ≤0.2 ng/ml in PSA-relapsed, hormone-sensitive patients treated with docetaxel.|While receiving study treatment (approximately 6 months)|Analysis includes all subjects who completed study regimen of 6 cycles.||participants|||Number
741696|NCT00481845|Primary|Tumor Objective Response by MRI|Determine tumor objective response rate by MRI. (CR): Disappearance of the target lesion (PR): At least a 30% decrease in the longest diameter of the target lesion taking as reference the baseline LD (PD): At least a 20% increase in the LD of target lesion, taking as reference the baseline LD or the appearance of one or more new lesions (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the baseline LD.|1 year|||Participants|||Count of Participants
741697|NCT00481871|Secondary|Progression-free Survival (PFS) Time|PFS time was calculated as the number of days from study day 1 to the date of PD or death, regardless of cause (date of PD or death – study day 1 + 1).|Response assessments were performed no less than every 3 cycles in the Phase 1 part of the study and every 8 weeks (± 1 week) in the Phase 2a part of the study|||days||95% Confidence Interval|Median
741698|NCT00481871|Secondary|Duration of Response|Duration of response was defined as the number of days between the date of first tumor response assessment of objective response to the time of the first tumor response assessment of progressive disease (PD) or death due to any cause (date of first PD assessment or death – date of first objective response assessment + 1)|Response assessments were performed no less than every 3 cycles in the Phase 1 part of the study and every 8 weeks (± 1 week) in the Phase 2a part of the study|||days||Full Range|Median
741699|NCT00481871|Primary|Objective Responses Assessed by International Workshop Criteria (IWC)|Number of participants who achieved an objective response. Objective response was defined as a tumor response assessment of either complete response (CR) or partial response (PR) and was determined only for patients with measurable disease at baseline. A tumor response assessment reported by IWC without PET was used for any analyses in cases where an IWC+PET evaluation was not done.|Assessed every 8 weeks (+/- 1 week) for Phase II and no less than every 3 cycles for Phase I|All patients who completed at least 1 cycle of treatment were included in the efficacy analysis||participants|||Number
741700|NCT00481988|Secondary|Beck Depression Inventory II|patient self report of depressive symptoms|Two weeks|Data for the secondary outcome measure was incompletely collected and not analyzed.|||||
741701|NCT00481988|Primary|Hamilton Rating Scale for Depression (24 Question Version), a Standardized Assessment Tool for Measuring Severity of Depression Where 0 is the Minimum Score (no Depressive Symptoms) and 40 is the Maximum (Severe Depression).|The Hamilton Rating Scale for Depression (HRS,24 question version), is a standardized assessment tool for measuring severity of depression where 0 is the minimum score (no depressive symptoms) and 40 is the maximum (severe depression).I am reporting the number of participants with stable remission which is defined as an HDRS < 10 for 2 weeks.|Two weeks|20 patients were enrolled in the study and 17 patients completed it. The 17 patients who completed the study are the population analyzed.||participants|||Number
741702|NCT00482014|Primary|Phase 2 - Survival Probability at 2 Years||Phase 2 randomization up to 2 years|All randomized participants in Study Phase 2.||percentage survival||95% Confidence Interval|Mean
741703|NCT00482014|Secondary|Phase 2 - Percentage of Participants With Complete Response or Partial Response (Response Rate)|Response rate is the percentage of participants with complete response (CR) or partial response (PR), as assessed according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. Response rate is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100.|Phase 2 randomization to the end of the treatment up to 30.0 months|All randomization participants in Study Phase 2.||percentage of participants||95% Confidence Interval|Number
741704|NCT00482014|Secondary|Phase 2 - Median Survival||Phase 2 randomization to death as the result of any cause up to 30.0 month|All randomized participants in Study Phase 2.||months||95% Confidence Interval|Median
741705|NCT00482014|Secondary|Phase 2 - Time to Progression|Time to disease progression was measured from randomization of Study Phase 2 to the first observation of disease progression according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Disease progression is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion.|Phase 2 randomization to measured disease progression up to 24 months|All randomized participants in Study Phase 2.||months||95% Confidence Interval|Median
741706|NCT00482014|Secondary|Phase 2 - Pharmacology Toxicity: Number of Participants With Adverse Events|Phase 2 pharmacology toxicity was defined as the number of participants who experienced serious adverse events or all other nonserious adverse events during the study. A summary of serious adverse events and other nonserious adverse events is located in the Reported Adverse Events section.|Phase 2 randomization to the end of the study treatment up to 30.0 months|All randomized participants who received at least 1 dose of study drug or 1 dose of radiation therapy (RT) during Study Phase 2.||participants|||Number
741707|NCT00482014|Secondary|Phase 1 - Percentage of Participants With Complete Response or Partial Response (Response Rate)|Response rate is the percentage of participants with complete response (CR) or partial response (PR), as assessed according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. Response rate is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100.|Phase 1 enrollment to the end of the study treatment up to Week 11|All participants who were enrolled in Study Phase 1 and received at least 1 dose of study drug and 1 dose of radiation therapy.||percentage of participants||95% Confidence Interval|Number
741708|NCT00482014|Secondary|Phase 1 - Pharmacology Toxicity: Number of Participants With Dose Limiting Toxicities (DLTs)|Phase 1 pharmacology toxicity was defined as the number of participants experiencing dose limiting toxicities (DLTs). DLT was defined as any of the following events occurring during the entire radiation therapy (RT) course: Grade 4 neutropenia (<0.5 x 10^9 cells per liter) >7 days, febrile neutropenia, ≥Grade 3 neutropenia with fever >38.5 degrees Celsius (°C), Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with ≥Grade 2 bleeding, ≥Grade 3 nonhematologic toxicity (excluding nausea, vomiting, and transaminase elevations), and ≥Grade 3 pulmonary or esophageal toxicity (radiation-related pneumonitis or esophagitis). Grade 5 events are the events leading to the death.|Phase 1 enrollment up to Week 11|All participants who were enrolled in Study Phase 1 and received at least 1 dose of study drug and 1 dose of radiation therapy.||participants|||Number
741773|NCT00482391|Secondary|Number of Patients Who Were Evaluated for Toxicity|Please see adverse event section in the results. Toxicities were assessed by the National Cancer Institute Common Toxicity Criteria (NCI CTC) version 3.0.|2 years|||Participants|||Count of Participants
741709|NCT00482014|Primary|Phase 1 - Maximum Tolerated Dose (MTD) of Cisplatin|MTD was defined as a dose at which the occurrence of at least 2 dose-limiting toxicities (DLTs) was observed. DLT was defined as any of the following events occurring during the entire radiation therapy (RT) course, including a 2-week recovery period following completion of RT: Grade 4 neutropenia (<0.5 x 10^9 cells per liter) lasting >7 days, febrile neutropenia; ≥Grade 3 neutropenia with fever >38.5 degrees Celsius (°C), Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with ≥Grade 2 bleeding, ≥Grade 3 nonhematologic toxicity (excluding nausea, vomiting, and transaminase elevations) and ≥Grade 3 pulmonary or esophageal toxicity (radiation-related pneumonitis or esophagitis).|Phase 1 enrollment to the end of study treatment up to Week 11|All participants who were enrolled in Study Phase 1 and completed at least 6 weeks of pemetrexed + cisplatin treatment.||milligrams/meter squared (mg/m²)|||Number
741710|NCT00482014|Primary|Phase 1 - Maximum Tolerated Dose (MTD) of Carboplatin|MTD was defined as a dose at which the occurrence of at least 2 dose-limiting toxicities (DLTs) was observed. DLT was defined as any of the following events occurring during the entire radiation therapy (RT) course, including a 2-week recovery period following completion of RT: Grade 4 neutropenia (<0.5 x 10^9 cells per liter) lasting >7 days, febrile neutropenia; ≥Grade 3 neutropenia with fever >38.5 degrees Celsius (°C), Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with ≥Grade 2 bleeding, ≥Grade 3 nonhematologic toxicity (excluding nausea, vomiting, and transaminase elevations) and ≥Grade 3 pulmonary or esophageal toxicity (radiation-related pneumonitis or esophagitis).|Phase 1 enrollment to the end of study treatment up to Week 11|All participants who were enrolled in Study Phase 1 and completed at least 6 weeks of pemetrexed + carboplatin treatment.||milligram/milliliter*minute (mg/mL*min)|||Number
741711|NCT00482170|Secondary|Influence of Prior Systemic Treatment or Topical Medication for Psoriasis on Participant Perception|Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. Numbers of participants with and without prior experience of systemic or topical treatment for psoriasis were determined for each cluster of participants.|Baseline|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.||participants|||Number
741712|NCT00482170|Secondary|Influence of Co-morbidities on Participant Perception|Participant perception: assessed with 26 questions of device attribute and participant questionnaire. Based on scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using multiple correspondence analysis and ascending hierarchical classification. Co-morbidities included current usage of tobacco and alcoholic beverages. Numbers of participants with and without co-morbidities were determined for each cluster of participants.|Baseline|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.||participants|||Number
741713|NCT00482170|Secondary|Influence of Dermatology Life Quality Index (DLQI) on Participant Perception|Participant perception: assessed with 26 questions of device attribute and participant questionnaire. Based on scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using multiple correspondence analysis and ascending hierarchical classification. DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. The DLQI score was determined for each cluster of participants.|Baseline|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.||units on a scale||Standard Deviation|Mean
741714|NCT00482170|Secondary|Influence of Participant's Global Assessment of Psoriasis on Participant Perception|Participant perception: assessed with 26 questions of device attribute and participant questionnaire. Based on scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using multiple correspondence analysis and ascending hierarchical classification. Participant’s global assessment of psoriasis was measured using a 100 mm VAS, with 0 = no activity and 100 = extremely active psoriasis. The participant’s assessment of psoriasis score was determined for each cluster of participants.|Baseline|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.||mm||Standard Deviation|Mean
741715|NCT00482170|Secondary|Influence of Participant's Assessment of General Health on Participant Perception|Participant perception: assessed with 26 questions of device attribute and participant questionnaire. Based on scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using multiple correspondence analysis and ascending hierarchical classification. Participant's assessment of general health was measured on 100mm line visual analog scale (VAS). 0mm = extremely bad to 100mm = very well. The participant’s assessment of general health score was determined for each cluster of participants.|Baseline|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.||mm||Standard Deviation|Mean
741724|NCT00482170|Secondary|Influence of Gender on Participant Perception|Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. Number of female and male participants was determined for each cluster of participants.|Baseline|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.||participants|||Number
745609|NCT00517192|Secondary|Response up to 48 Weeks Using at Least a 1 log10 Reduction in Viral Load From Baseline Using NCF||up to 48 weeks||||||
741716|NCT00482170|Secondary|Influence of Psoriasis Area Severity Index (PASI) on Participant Perception|Participant perception:assessed with 26 questions of device attribute and participant questionnaire. Based on scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using multiple correspondence analysis and ascending hierarchical classification. PASI: combined assessment of lesion severity and area affected into single score; range: 0=no disease to 72=maximal disease. While assessing, body was divided into 4 sections: head, upper extremities, trunk, lower extremities. PASI score was determined for each cluster of participants.|Baseline|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.||units on a scale||Standard Deviation|Mean
741717|NCT00482170|Secondary|Influence of Physician Global Assessment (PGA) of Psoriasis on Participant Perception|Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. PGA of psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). 'Clear' and 'Almost clear' includes all participants who were scored as a 0 or 1. The PGA score was determined for each cluster of participants.|Baseline|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.||units on a scale||Full Range|Median
741718|NCT00482170|Secondary|Influence of Duration of Psoriasis on Participant Perception|Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. The duration of psoriasis was determined for each cluster of participants.|Baseline|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.||years||Standard Deviation|Mean
741719|NCT00482170|Secondary|Influence of Prior Self-injection Experience on Participant Perception|Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. Numbers of participants with and without prior self-injection experience were determined for each cluster of participants.|Baseline|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.||participants|||Number
741720|NCT00482170|Secondary|Influence of Prior Injection Experience on Participant Perception|Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. Numbers of participants with and without prior injection experience were determined for each cluster of participants.|Baseline|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.||participants|||Number
741721|NCT00482170|Secondary|Influence of Willingness to Self Manage Assessed by Patient Activation Measure (PAM) on Participant Perception|Participant perception: assessed with 26 questions of device attribute and participant questionnaire. Based on scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied, less satisfied) using multiple correspondence analysis and ascending hierarchical classification. The 13-item short form of PAM survey assessed participants' knowledge, skill, and confidence for self-management; score range 0 to 100. Higher scores indicated more confidence in managing participants' condition and lifestyle. PAM score was determined for each cluster of participants.|Baseline|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.||units on a scale||Standard Deviation|Mean
741722|NCT00482170|Secondary|Influence of Psychological Status Assessed by Hospital Anxiety Depression (HAD) Score on Participant Perception|Participant perception: assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied, less satisfied) using multiple correspondence analysis and an ascending hierarchical classification. Psychological status: assessed using participant rated questionnaire with 2 subscales for anxiety (HAD-A) and depression (HAD-D). Total score: 0 to 21 for each subscale; higher score = greater severity of symptoms. HAD score was determined for each cluster of participants.|Baseline|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.||units on a scale||Full Range|Median
741723|NCT00482170|Secondary|Influence of Socio-educational Status on Participant Perception|Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. Number of participants corresponding to each socio-educational level (reading or writing, high school or baccalaureate level, university level) was determined for each cluster of participants.|Baseline|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.||participants|||Number
748841|NCT00538642|Secondary|Triglycerides||Baseline|||mg/dL||Standard Deviation|Mean
741725|NCT00482170|Secondary|Influence of Age on Participant Perception|Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. The age was determined for each cluster of participants.|Baseline|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.||years||Standard Deviation|Mean
741726|NCT00482170|Secondary|Short Form State-Trait Anxiety Inventory (SF STAI) Global Score|SF-STAI is a 6 item short form. Global score = sum of coded answers/number of answered questions multiplied by 6, with answers coded on a 4 point Likert scale, where 1 = least anxious and 4 = most anxious. The global score ranges from 6 to 24, where higher score shows greater anxiety.|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.||units on a scale||Standard Deviation|Mean
741727|NCT00482170|Secondary|Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection|"Side effects related to administration were assessed by participant's response to question, Do you experience pain during or immediately after the injection? scored on a 5-point Likert scale (0= none to 4= severe)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.||participants|||Number
741728|NCT00482170|Secondary|Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks|"Device characteristics were assessed by participant's response to question, How much does the device look like something you would feel comfortable to use? scored on a 5-point Likert scale (0= not at all to 4= very much)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.||participants|||Number
741729|NCT00482170|Secondary|Device Characteristics Based on Response to Question Concerning Feel of Device|"Device characteristics were assessed by participant's response to question, How much do you like the feel of the device? scored on a 5-point Likert scale (0= not at all to 4= very much)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.||participants|||Number
741730|NCT00482170|Secondary|Device Characteristics Based on Response to Question Concerning Look of Device|"Device characteristics were assessed by participant's response to question, How much do you like the look of the device? scored on a 5-point Likert scale (0= not at all to 4= very much)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.||participants|||Number
741731|NCT00482170|Secondary|Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection|"Fear of Device was assessed by participant's response to question, Are you emotionally distressed or anxious about your injections? scored on a 5-point Likert scale (0= not at all to 4= very much)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.||participants|||Number
741732|NCT00482170|Secondary|Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device|"Fear of Device was assessed by participant's response to question, Do you dislike injecting yourself with this device? scored on a 5-point Likert scale (0= not at all to 4= very much)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.||participants|||Number
741733|NCT00482170|Secondary|Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin|"Fear of Device was assessed by participant's response to question, How nervous do you feel about inserting the needle into your skin? scored on a 5-point Likert scale (0= not at all to 4= very much)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.||participants|||Number
741734|NCT00482170|Secondary|Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections|"Fear of Device was assessed by participant's response to question, How nervous do you feel about your injections? scored on a 5-point Likert scale (0= not at all to 4= very much)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.||participants|||Number
741735|NCT00482170|Secondary|Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection|"Confidence in injection device was assessed by participant's response to question, How confident are you that you injected yourself successfully? scored on a 5-point Likert scale (0= not at all to 4= very much)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.||participants|||Number
741736|NCT00482170|Secondary|Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process|"Confidence in injection device was assessed by participant's response to question, Are you confident that you have good control over the injection process? scored on a 5-point Likert scale (0= not at all to 4= very much)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.||participants|||Number
741737|NCT00482170|Secondary|Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device|"Confidence in injection device was assessed by participant's response to question, How confident are you that you can inject yourself properly with the device? scored on a 5-point Likert scale (0= not at all to 4= very much)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.||participants|||Number
745610|NCT00517192|Secondary|Response up to 48 Weeks Using at Least a 1 log10 Reduction in Viral Load From Baseline Using Censored||up to 48 weeks||||||
741738|NCT00482170|Secondary|Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time|"Confidence in injection device was assessed by participant's response to question, How confident are you that you inject the right amount of medicine every time? scored on a 5-point Likert scale (0= not at all to 4= very much)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.||participants|||Number
741739|NCT00482170|Secondary|Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections|"Confidence in injection device was assessed by participant's response to question, How confident are you in your management of your injections? scored on a 5-point Likert scale (0= not at all to 4= very much)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.||participants|||Number
741740|NCT00482170|Secondary|Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling|"Convenience of injection device was assessed by participant's response to question, How much do you think injecting etanercept will interfere with travelling on holiday or business or visiting? scored on a 5-point Likert scale (0= not at all to 4= very much)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.||participants|||Number
741741|NCT00482170|Secondary|Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity|"Convenience of injection device was assessed by participant's response to question, Do you think injecting etanercept will interfere with your usual daily activities? scored on a 5-point Likert scale (0= not at all to 4= very much)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.||participants|||Number
741742|NCT00482170|Secondary|Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity|"Convenience of injection device was assessed by participant's response to question, How much do you think injecting etanercept will interfere with your ability to enjoy social or leisure activities? scored on a 5-point Likert scale (0= not at all to 4= very much)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.||participants|||Number
741743|NCT00482170|Secondary|Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal)|"Ease of Use of Injection Device was assessed by participant's response to question, How long does it take to perform the injection, including any preparation and disposal? where time spent was recorded in minutes and categorized into 5 categories, ranging from 'less than 5 minutes' to 'more than 30 minutes'."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the time point for each group respectively.||participants|||Number
741744|NCT00482170|Secondary|Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting|"Ease of use of injection device was assessed by participant's response to question, Did you feel any hand discomfort whilst using the device? scored on a 5-point Likert scale (0= none to 4= extreme)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the time point for each group respectively.||participants|||Number
741745|NCT00482170|Secondary|Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting|"Ease of use of injection device was assessed by participant's response to question, How easy is it to hold the device whilst injecting? scored on a 5-point Likert scale (0= very easy to 4= very difficult)"|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the time point for each group respectively.||participants|||Number
741746|NCT00482170|Secondary|Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete|"Ease of use of injection device was assessed by participant's response to question, How easy is it to know when the injection is completed? scored on a 5-point Likert scale (0= very easy to 4= very difficult)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the time point for each group respectively.||participants|||Number
741747|NCT00482170|Secondary|Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device|"Ease of use of injection device was assessed by participant's response to question, How easy was it to dispose of the device? scored on a 5-point Likert scale (0= very easy to 4= very difficult)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the time point for each group respectively.||participants|||Number
741748|NCT00482170|Secondary|Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device|"Ease of use of injection device was assessed by participant's response to question, How easy was it to use the device? scored on a 5-point Likert scale (0= very easy to 4= very difficult)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the time point for each group respectively.||participants|||Number
741769|NCT00482274|Secondary|Time to Androgen Independent State|Due to the limited enrollment, this analysis was not completed.|Measured at date of documented androgen independence (no estimate available)|Due to the limited enrollment, this analysis was not completed.|||||
745611|NCT00517192|Secondary|Response up to 48 Weeks Using VL < 400 Copies/mL Using Intent-to-treat||up to 48 weeks||||||
741749|NCT00482170|Secondary|Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device|"Ease of use of injection device was assessed by participant's response to question, How easy was it to perform an injection with this device? scored on a 5-point Likert scale (0= very easy to 4= very difficult)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the time point for each group respectively.||participants|||Number
741750|NCT00482170|Secondary|Influence of Prior Injection Experience on Participant Satisfaction With Injection Device|Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the injection device. The categories were defined based on presence of any prior experience of injection. Participants were divided into categories: yes and no.|Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.||units on a scale||Standard Deviation|Mean
741751|NCT00482170|Secondary|Influence of Prior Systemic Treatment or Topical Medication for Psoriasis on Participant Satisfaction With Injection Device|Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the injection device. The categories were defined based on presence of any prior experience of systemic treatment or topical medication for psoriasis. Participants were divided into categories: yes and no.|Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.||units on a scale||Standard Deviation|Mean
741752|NCT00482170|Secondary|Influence of Co-morbidities on Participant Satisfaction With Injection Device|Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. Co-morbidities categories were defined based on current usage of tobacco and alcoholic beverages. Participants were divided into categories, yes and no, for both current tobacco usage and current alcohol usage.|Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.||units on a scale||Standard Deviation|Mean
741753|NCT00482170|Secondary|Influence of Dermatology Life Quality Index (DLQI) on Participant Satisfaction With Injection Device|Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. Score categories were defined based on quartiles of DLQI scores observed. Participants were divided into quarters: =< 8, > 8 to 13, > 13 to 18, > 18.|Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.||units on a scale||Standard Deviation|Mean
741754|NCT00482170|Secondary|Influence of Participant's Global Assessment of Psoriasis on Participant Satisfaction With Injection Device|Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. Participant’s global assessment of psoriasis was measured using a 100 mm VAS, with 0 = no activity and 100 = extremely active psoriasis. Score categories were defined based on quartiles of participant’s global assessment of psoriasis scores observed. Participants were divided into quarters: =< 63, > 63 to 76, > 76 to 88, > 88.|Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.||units on a scale||Standard Deviation|Mean
741755|NCT00482170|Secondary|Influence of Participant's Assessment of General Health on Participant Satisfaction With Injection Device|Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. Participant's assessment of general health was measured on 100 millimeter (mm) line visual analog scale (VAS). 0 mm = extremely bad to 100 mm = very well. Score categories were defined based on quartiles of VAS score observed. Participants were divided into quarters: =< 48, > 48 to 67.25, > 67.25 to 84, > 84.|Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.||units on a scale||Standard Deviation|Mean
741756|NCT00482170|Secondary|Influence of Psoriasis Area and Severity Index (PASI) on Participant Satisfaction With Injection Device|Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. PASI: combined assessment of lesion severity and area affected into single score; range: 0= no disease to 72= maximal disease. Score categories were defined based on quartiles of PASI score observed. Participants were divided into quartiles: =< 11.2, > 11.2 to 16.2, > 16.2 to 21.9, > 21.9.|Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.||units on a scale||Standard Deviation|Mean
741757|NCT00482170|Secondary|Influence of Physician Global Assessment (PGA) of Psoriasis on Participant Satisfaction With Injection Device|Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. PGA of Psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). 'Clear' and 'Almost clear' includes all participants who were scored as a 0 or 1. Score categories were defined based on quartiles of PGA scores observed. Participants were divided into: =< 3, > 3 to 4, > 4.|Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.||units on a scale||Standard Deviation|Mean
741770|NCT00482274|Secondary|Time to Metastatic Disease|Due to the limited enrollment, this analysis was not completed.|Measured at Time of documented metastases (no historical estimate is available)|Due to limited enrollment, this analysis was not completed|||||
741774|NCT00482391|Primary|Number of Patients Who Completed All Planned Therapy|The number of patients who completed all planned therapy (dose-dense adjuvant/ neoadjuvant chemotherapy regimen) in HER-2/neu-overexpressed/ amplified breast cancer patients.|2 years|||participants|||Number
741758|NCT00482170|Secondary|Influence of Duration of Psoriasis on Participant Satisfaction With Injection Device|Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the injection device. Duration of psoriasis categories were defined based on quartiles of the duration of psoriasis observed. Participants were divided into quarters: =< 11 years, > 11 years to 19 years, > 19 years to 28 years, > 28 years.|Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.||units on a scale||Standard Deviation|Mean
741759|NCT00482170|Secondary|Influence of Prior Self-injection Experience on Participant Satisfaction With Injection Device|Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the injection device. The categories were defined based on presence of any prior experience of self-injection. Participants were divided into categories: yes and no.|Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.||units on a scale||Standard Deviation|Mean
741760|NCT00482170|Secondary|Influence of Willingness to Self Manage as Assessed by Patient Activation Measure (PAM) on Participant Satisfaction With Injection Device|Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. The 13-item short form of the PAM survey assessed participants' knowledge, skill, and confidence for self-management; calibrated scale score ranged from 0 to 100. Higher scores indicated more confidence in managing participants' condition and lifestyle. Score categories were defined based on quartiles of PAM scores observed. Participants were divided into quarters: =< 47.4, > 47.4 to 56.4, > 56.4 to 68.5, > 68.5.|Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.||units on a scale||Standard Deviation|Mean
741761|NCT00482170|Secondary|Influence of Psychological Status as Assessed by Hospital Anxiety Depression (HAD) Score on Participant Satisfaction With Injection Device|Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher score = greater satisfaction with injection device. Psychological status was assessed using participant rated questionnaire with 2 subscales for anxiety (HAD-A) and depression (HAD-D). Total score: 0 to 21 for each subscale; higher score = greater severity of symptoms. Score categories were based on quartiles of HAD-A and HAD-D scores observed. Participants were divided into quarters: =< 4, > 4 to 7, > 7 to 10, > 10 for HAD-A and =< 3, > 3 to 5, > 5 to 8, > 8 for HAD-D.|Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.||units on a scale||Standard Deviation|Mean
741762|NCT00482170|Secondary|Influence of Socio-educational Status on Participant Satisfaction With Injection Device|Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism. Socio-educational status categories were defined as reading or (/) writing capacity, high school /baccalaureate level and university level.|Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.||units on a scale||Standard Deviation|Mean
741763|NCT00482170|Secondary|Influence of Gender on Participant Satisfaction With Injection Device|Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism. Gender categories were defined as male and female.|Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.||units on a scale||Standard Deviation|Mean
741764|NCT00482170|Secondary|Influence of Age on Participant Satisfaction With Injection Device|Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism. Age categories were defined based on quartiles (Q) of ages observed. Participants were divided into quarters: less than or equal to (=<) 36 years, greater than (>) 36 years to 45 years, > 45 years to 55 years, > 55 years.|Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. Last observation carried forward (LOCF) method was used to impute missing values.||units on a scale||Standard Deviation|Mean
741765|NCT00482170|Secondary|Percentage of Participants Satisfied With Injection Device|Participant satisfaction was assessed by asking the question “Are you satisfied with your injection device? and using a dichotomous response: Yes or No.|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the time point for each group respectively.||percentage of participants|||Number
741766|NCT00482170|Primary|Participant Satisfaction With Injection Device at Week 12 for Per-protocol (PP) Population|"Participant satisfaction was assessed by asking the question, How satisfied are you with your injection device? using a 0-10 point scale, where 0= totally dissatisfied and 10= totally satisfied."|Week 12|Per-protocol (PP) analysis population included participants from mITT population who completed the study with no major protocol violations. Here, ‘N’ (number of participants analyzed) is signifying those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
741767|NCT00482170|Primary|Participant Satisfaction With Injection Device Evaluated at Week 12 for Modified Intent-to-treat (mITT) Population|"Participant satisfaction was assessed by asking the question, How satisfied are you with your injection device? using a 0-10 point scale, where 0= totally dissatisfied and 10= totally satisfied."|Week 12|Modified intent-to-treat (mITT) analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. Here, ‘N’ (number of participants analyzed) is signifying those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
741768|NCT00482274|Secondary|Time to Death From Any Cause|Due to the limited enrollment, this analysis was not completed.|measured at date of death (no estimate available)|Due to the limited enrollment, this analysis was not completed.|||||
745612|NCT00517192|Secondary|Response up to 48 Weeks Using VL < 400 Copies/mL Using NCF||up to 48 weeks||||||
741775|NCT00482547|Other Pre-specified|Number of Subjects With a sUTI Catheterized for >=48 Hours.|sUTI occurences were counted in subjects of both study groups who had been catheterized with a study catheter for >= 48 hours and who did not have evidence of bUTI at the time of study catheter insertion.|From time of catheterization until 10 days or 48 hours after catheter was removed|Efficacy Evaluable (48) population: ITT subjects who were catheterized with a study catheter for ≥ 48 hours and who did not have a bUTI in the baseline urine sample obtained at the time of catheter insertion.||Participants|||Number
741776|NCT00482547|Other Pre-specified|Number of Subjects With a bUTI Catheterized for >=48 Hours.|bUTI occurences were counted in subjects of both study groups who had been catheterized with a study catheter for >= 48 hours and who did not have evidence of bUTI at the time of study catheter insertion.|From time of catheterization until 10 days post catheterization or 48 hours after catheter removal.|Efficacy Evaluable (48) population: ITT subjects who were catheterized with a study catheter for ≥ 48 hours and who did not have a bUTI in the baseline urine sample obtained at the time of catheter insertion.||Participants|||Number
741777|NCT00482547|Secondary|Number of Participants With Bacteriuria at a Concentration of ≥ 10e3 < 10e5 CFU/mL|The number of subjects with bacteriuria levels ≥ 10e3 < 10e5 CFU/mL who subsequently developed a bUTI or a sUTI|10 days|Safety population: ITT subjects who were catheterized with a study catheter. This population was used to assess tolerability and safety endpoints.||Participants|||Number
741778|NCT00482547|Secondary|Time to Occurance of sUTI in Subjects Catheterized for >= 24 Hours|The time to occurrence of sUTI was measured as the time between catheter insertion and when the criteria for sUTI was met, up to 10 days after catheterization plus 48 hours after catheter removal. Subjects who did not have a sUTI are not included in the median calculation, so the median only includes data from non-censored observations.|>= 24 hours to 10 days|Efficacy Evaluable (24) population: ITT subjects who were catheterized with a study catheter for ≥ 24 hours and who developed a bUTI after catheter insertion.||Days||Standard Deviation|Median
741779|NCT00482547|Secondary|Time to Occurence of bUTI in Subjects Catheterized for >= 24 Hours|Time to occurrence of bUTI in subjects of both study groups who were catheterized with a study catheter for >= 24 hours and developed a bUTI at after catheter insertion. Subjects who did not have a bUTI are not included in the median calculation, so the median only includes data from non-censored observations.|>= 24 hours to 10 days|Efficacy Evaluable (24) population: ITT subjects who were catheterized with a study catheter for ≥ 24 hours and who developed a bUTI after catheter insertion.||Days||Standard Deviation|Median
741780|NCT00482547|Secondary|Time to Occurence of Symptomatic Urinary Tract Infection (sUTI) in Subjects Catheterized for >= 48 Hours|The time to occurrence of sUTI was measured as the time between catheter insertion and when the criteria for sUTI was met, up to 10 days after catheterization plus 48 hours after catheter removal. Subjects who did not have a sUTI are not included in the median calculation, so the median only includes data from non-censored observations.|>= 48 hours to 10 days|Efficacy Evaluable (48) population: ITT subjects who were catheterized with a study catheter for ≥ 48 hours and who developed a sUTI after catheter insertion.||Days||Standard Deviation|Median
741781|NCT00482547|Primary|Time to Occurrence of Bacteriuric Urinary Tract Infection (bUTI) in Subjects Catheterized for >= 48 Hours|Time to occurrence of bUTI in subjects of both study groups who were catheterized with a study catheter for >= 48 hours and who had evidence of bUTI after study catheter insertion. Subjects who did not have a bUTI are not included in the median calculation, so the median only includes data from non-censored observations.|>=48 hours to 10 days|Efficacy Evaluable (48) population: Intent-to-treat (ITT) subjects who were catheterized with a study catheter for ≥ 48 hours and who developed a bUTI after catheter insertion.||Days||Standard Deviation|Median
741782|NCT00482547|Secondary|Percentage of Participants With a bUTI After Catheterization for >= 48 Hours|The percentage of bUTI was calculated as the rate of new occurrence of bUTI in subjects of both study groups who had been catheterized with a study catheter for >= 48 hours and who did not have evidence of bUTI at the time of study catheter insertion.|>=48 hours to 10 days|Efficacy Evaluable (48) population: ITT subjects who were catheterized with a study catheter for ≥ 48 hours and who did not have a bUTI in the baseline urine sample obtained at the time of catheter insertion.||Percentage of Participants with a bUTI|||Number
741783|NCT00482612|Secondary|Number of Participants Who Discontinued From Study Treatment Due to an AE During the 14-day In-Treatment Period|The total number of participants discontinuing from study treatment due to experiencing an AE was tallied for each treatment arm. An AE was defined as any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|Day 1 to Day 15|The All-Subjects-Treated Group consisted of all participants who received at least 1 dose of trial medication.||Number of participants|||Number
741784|NCT00482612|Secondary|Number of Participants Experiencing an Adverse Event (AE) During the 14-day In-treatment Period|The total number of participants with an AE during the 14-day In-treatment Period was tallied for each treatment arm. An AE was defined as any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|Day 1 to Day 15|The All-Subjects-Treated Group consisted of all participants who received at least 1 dose of trial medication.||Number of participants|||Number
741785|NCT00482612|Secondary|Average Sleep Latency (SL) as Recorded Daily in the Sleep Diary During the 14-day In-treatment Period|SL was defined as the duration of time measured in minutes that it took a participant to fall asleep as recorded daily in the participant's sleep diary. SL values over the 14-day active treatment period were averaged for each participant, and average SL was then reported by treatment arm. For participants with missing data, the average of the nights for which TST data were present were used in the analysis.|Day 1 to Day 15|The Intent-To-Treat Group consisted of all randomized participants who received at least one dose of double-blind trial medication and had baseline and at least one post-baseline measurement for at least one efficacy assessment.||Minutes||Standard Deviation|Mean
748842|NCT00538642|Secondary|Diastolic Blood Pressure||4-5 months|||mm Hg||Standard Deviation|Mean
741786|NCT00482612|Primary|Average Total Sleep Time (TST) as Recorded Daily in the Sleep Diary During the 14-day In-treatment Period|TST was defined as the total amount of time (measured in minutes) that was actually spent sleeping the previous night as recorded daily in the participant's sleep diary. TST values over the 14-day active treatment period were averaged for each participant, and average TST was then reported by treatment arm. For participants with missing data, the average of the nights for which TST data were present was used in the analysis.|Day 1 to Day 15|The Intent-To-Treat Group consisted of all randomized participants who received at least one dose of double-blind trial medication, and had baseline and at least one post-baseline measurement for at least one efficacy assessment.||Minutes||Standard Deviation|Mean
741787|NCT00482625|Secondary|Number of Participants Reported at Least 1 Adverse Event With a Grade of 3 and Above|The worst grade of pre-listed toxicity will be summarized by participant and by visit for each treatment group. Descriptive statistics (frequencies and percents) will be used to summarize data and hypotheses about group differences will be tested where appropriate.|Up to 20 weeks|||participants|||Number
741788|NCT00482625|Secondary|Pancreas Calculated Concentration - OSI-420 (ng/g)|Pancreatic tissue concentration levels of Erlotinib (OSI-420)|20 weeks|||ng/g||Standard Deviation|Mean
741789|NCT00482625|Secondary|Plasma Calculated Concentration - OSI-420 (ng/mL)|Plasma concentration levels of Erlotinib (OSI-420)|20 weeks|||ng/mL||Standard Deviation|Mean
741790|NCT00482625|Secondary|Pancreas Calculated Concentration - OSI-774 (ng/g)|Pancreatic tissue concentration levels of Erlotinib (OSI-774)|20 weeks|||ng/g||Standard Deviation|Mean
741791|NCT00482625|Secondary|Plasma Calculated Concentration - OSI-774 (ng/mL)|Plasma concentration levels of Erlotinib (OSI-774)|20 weeks|||ng/mL||Standard Deviation|Mean
741792|NCT00482625|Primary|Reduction in Number of Positive IPMN Celss and Staining Intensity After Treatment|Number of participants showed a reduction in number of positive IPMN cells and staining intensity after treatment|Pre-treatment and post-treatment|||participants|||Number
741793|NCT00482703|Other Pre-specified|Number of Participants With Progression-Free Survival (PFS) at Months 0 - 24 (PFS Life Table)|Progressed disease=achieving a CHR and subsequently no longer meeting criteria consistently over a consecutive 2-week period after starting maximum dose; no CHR after receiving maximum dose and an increase in white blood cell count (doubling of the count from lowest value to >20,000/mm3 or an increase by >50,000/mm3 on 2 assessments done at least 2 weeks apart); meeting the criteria of accelerated or blastic phase CML at any time; having an MCyR and subsequently no longer meeting the criteria for MCyR after starting maximum dose; or having a >=30% absolute increase in number of Ph+ metaphases.|Months 0, 4, 8, 12, 16, 20, 24|Treated participants. Median duration was not reached at the time of this report (see Outcome Measure 7)||participants|||Number
741794|NCT00482703|Other Pre-specified|Number of Participants With CHR at Months 0 - 24 (Duration of MCyR Life Table)|CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets < 450,000/mm³; no blasts or promyelocytes in peripheral blood; < 5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils < 20%; no extramedullary involvement. A confirmed CHR (cCHR) is obtained when all above criteria are maintained for at least 28 days after they are first met. All hematologic responses can begin only 14 days after the dosing start date.|Months 0, 4, 8, 12, 16, 20, 24|Treated participants. Median duration was not reached at the time of this report (see Outcome Measure 7)||participants|||Number
741795|NCT00482703|Other Pre-specified|Number of Participants With Major Cytogenetic Response at Months 0 - 24 (Duration of MCyR Life Table)|MCyR = a complete and a partial cytogenetic response (CyR), based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each bone marrow sample. Percentage of Ph+ Cells in Metaphase in BM: Complete Cytogenetic Response (CCyR) = 0; Partial Cytogenetic Response (PCyR) 1 - 35|Months 0, 4, 8, 12, 16, 20, 24|Treated participants. Median duration was not reached at the time of this report (see Outcome Measure 6)||participants|||Number
741796|NCT00482703|Secondary|Hematologic Response in Imatinib-Intolerant and Imatinib-Resistant Participants at End of Study|CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets < 450,000/mm³; no blasts or promyelocytes in peripheral blood; < 5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils < 20%; no extramedullary involvement. A confirmed CHR (cCHR) is obtained when all above criteria are maintained for at least 28 days after they are first met. All hematologic responses can begin only 14 days after the dosing start date.|Baseline and at the end of long term extension period (The enrollment period was followed by an extension period until the launch of dasatinib in Japan, January 2009.)|All treated participants||percentage of participants||95% Confidence Interval|Number
741797|NCT00482703|Secondary|Cytogenetic Response in Imatinib-Intolerant and Imatinib-Resistant Participants at End of Study|Cytogenetic response (CyR) as reflected in the major cytogenetic response was determined by bone marrow (BM) aspirates and are based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each BM sample. Major Cytogenetic Response (MCyR) = Complete Cytogenetic Response (CCyR; 0 Ph+ Cells in Metaphase in BM), or Partial Cytogenetic Response (PCyR; 1 - 35 Ph+ Cells in Metaphase in BM).|Baseline and at the end of long term extension period (The enrollment period was followed by an extension period until the launch of dasatinib in Japan, January 2009.)|All treated participants||percentage of participants||95% Confidence Interval|Number
741798|NCT00482703|Secondary|Mutational Spectrum of BCR-ABL|Number of participants with a particular BCR-ABL mutation at Baseline and End-of-Study.|Baseline and at the end of long term extension period (The enrollment period was followed by an extension period until the launch of dasatinib in Japan, January 2009.)|Treated participants||participants|||Number
741799|NCT00482703|Secondary|Expression of BCR-ABL Gene Mutations of RNA (mRNA)|Number of participants with positive (>= 2.0 log copies/mg) and negative (<2.0 log copies/mg) expression of mRNA at Baseline and at end of study.|Baseline and at the end of long term extension period (The enrollment period was followed by an extension period until the launch of dasatinib in Japan, January 2009.)|Treated participants||participants|||Number
741810|NCT00482729|Other Pre-specified|Change From Baseline in A1C at Week 44|A1C is measured as percent. Thus, this change from baseline reflects the Week 44 A1C percent minus the Week 0 A1C percent.|Baseline and Week 44|The Full Analysis Set (FAS) included all patients who received at least 1 dose of double-blind study therapy, had a baseline value and ≥1 post-baseline value for this outcome. Data after initiation of additional AHA were included. For FAS with no data at Week 44, the last post-baseline observed measurement was carried forward to Week 44.||Percent||95% Confidence Interval|Least Squares Mean
741800|NCT00482703|Secondary|Progression-Free Survival (PFS)|Progressed disease=achieving a CHR & subsequently no longer meeting criteria consistently over a consecutive 2-week period after starting maximum dose; no CHR after receiving maximum dose & increase in white blood cell count (doubling of count from lowest value to >20,000/mm3 or an increase by >50,000/mm3 on 2 assessments done ≥2 weeks apart); meeting the criteria of accelerated or blastic phase chronic myeloid leukemia at any time; having an MCyR & subsequently no longer meeting the criteria for MCyR after starting maximum dose; or having a >=30% absolute increase in number of Ph+ metaphases.|time from first dose of Dasatinib (BMS-354825) until the first day criteria for CCyR or PCyR, whichever occurs first, are first met|Median months of progression-free survival was not reached at the time of this report. See corresponding life table in Outcome Measure 16.||months||95% Confidence Interval|Median
741801|NCT00482703|Secondary|Duration of CHR|The duration of CHR were measured from the first day all criteria were first met for CHR (provided subjects achieved a cCHR), until the date PD is first reported or until death. Subjects who neither progress nor die were censored on the date of their last hematologic assessment.|measured from the first day all criteria were first met for CHR (provided subjects achieved a cCHR), until the date PD is first reported or until death|Median duration of CHR was not reach at the time of this report. See corresponding life table presented in Outcome Measure 15.||months||95% Confidence Interval|Median
741802|NCT00482703|Secondary|Time to CHR|Time to CHR = time from first dose of Dasatinib until the first day CHR criteria are met (provided subjects achieved a cCHR). CHR=all of the following criteria: white blood cell count ≤ upper limit of normal; platelets <450,000/mm³; no blasts or promyelocytes in peripheral blood; <5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils <20%; no extramedullary involvement. A confirmed CHR (cCHR) is obtained when all above criteria are maintained for at least 28 days after they are first met. All hematologic responses can begin only 14 days after the dosing start date.|time from first dose of Dasatinib (BMS-354825) until the first day CHR criteria are met|Treated participants - responders||months||95% Confidence Interval|Median
741803|NCT00482703|Secondary|Duration of MCyR|The duration of MCyR will be measured from the first day all criteria are met for CCyR or PCyR until the date of progressed disease (PD) or death. Subjects who neither progress nor die will be censored on the date of their last cytogenetic assessment.MCyR = a complete and a partial cytogenetic response (CyR), based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each bone marrow sample. Percentage of Philadelphia-positive (Ph+) Cells in Metaphase in bone marrow: Complete Cytogenetic Response (CCyR) = 0; Partial Cytogenetic Response (PCyR) 1 - 35|from the first day all criteria are met for CCyR or PCyR until the date of progressed disease (PD) or death|Median duration was not reached at the time of this report; see Outcome Measure 14 for corresponding life table.||months||95% Confidence Interval|Median
741804|NCT00482703|Secondary|Pharmacokinetics of Dasatinib (BMS-354825) as Characterized by Population Pharmacokinetics|Blood sample collection for pharmacokinetic (PK) analysis that will contribute to PK modeling.|Six or more peripheral blood samples were collected at any visit after Day 7, pre-dose and 5 - 8 hours after dose administration.|Blood samples were collected for PK to be included in separate population PK analyses. No study specific PK analyses were planned for this report.||participants|||Number
741805|NCT00482703|Secondary|Time to Major Cytogenetic Response (MCyR)|Time to MCyR is defined as the time from first dose of Dasatinib (BMS-354825) until the first day criteria for CCyR or PCyR, whichever occurs first, are first met. MCyR = a complete and a partial cytogenetic response (CyR), based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each bone marrow sample. Percentage of Ph+ Cells in Metaphase in bone marrow: Complete Cytogenetic Response (CCyR) = 0; Partial Cytogenetic Response (PCyR) 1 - 35|time from first dose of Dasatinib (BMS-354825) until the first day criteria for CCyR or PCyR, whichever occurs first, are first met|Treated participants - responders||months||95% Confidence Interval|Median
741806|NCT00482703|Secondary|Complete Hematologic Response (CHR) in Imatinib-Intolerant and Imatinib-Resistant Participants at Week 24|CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets < 450,000/mm³; no blasts or promyelocytes in peripheral blood; < 5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils < 20%; no extramedullary involvement. A confirmed CHR (cCHR) is obtained when all above criteria are maintained for at least 28 days after they are first met. All hematologic responses can begin only 14 days after the dosing start date.|Week 24|All treated participants||percentage of participants||95% Confidence Interval|Number
741807|NCT00482703|Secondary|Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations, and Deaths During Treatment|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|Throughout study period to last observation. Dosing period=6 months; if beneficial, medication may continue in the extension period (ending in January 2009). Last observation=30 days past last dosing day or the discontinuation day.|All treated participants||participants|||Number
741808|NCT00482703|Primary|Cytogenetic Response in Imatinib-Intolerant and Imatinib-Resistant Participants at Week 24|Cytogenetic responses (CyR) are based on the percentage of Philadelphia-positive (Ph+) metaphases among at least 20 metaphase cells in each bone marrow (BM) sample. The criteria for cytogenetic responses are as follows. Best CyR is defined as the best response obtained at any time during the study. Major Cytogenetic Response (MCyR) = Complete Cytogenetic Response (CCyR; 0 Ph+ Cells in Metaphase in BM), and Partial Cytogenetic Response (PCyR; 1 - 35 Ph+ Cells in Metaphase in BM).|Week 24|All treated participants||percentage of participants||95% Confidence Interval|Number
741809|NCT00482729|Other Pre-specified|Number of Patients With A1C < 7.0% at Week 44||Week 44|The Full Analysis Set (FAS) included all patients who received at least 1dose of double-blind study therapy, had a baseline value and ≥1 post-baseline value for this outcome. Data after initiation of additional AHA were included. For FAS with no data at Week 44, the last post-baseline observed measurement was carried forward to Week 44.||Participants|||Number
741845|NCT00483262|Secondary|Progression-Free Survival|Median time to progression or death|10 months|||month||95% Confidence Interval|Median
745613|NCT00517192|Secondary|Response up to 48 Weeks Using VL < 400 Copies/mL Using Censored||up to 48 weeks||||||
741811|NCT00482729|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18|FPG is measured as mg/dL. Thus, this change from baseline reflects the Week 18 FPG mg/dL minus the Week 0 FPG mg/dL.|Baseline and Week 18|The Full Analysis Set (FAS) included all patients who received at least 1dose of double-blind study therapy, had a baseline value and ≥1 post-baseline value for this outcome. Data after initiation of additional AHA were treated as missing. For FAS with no data at Week 18, the last post-baseline observed measurement was carried forward to Week 18.||mg/dL||95% Confidence Interval|Least Squares Mean
741812|NCT00482729|Secondary|Number of Patients With A1C < 7.0% at Week 18||Week 18|The Full Analysis Set (FAS) included all patients who received at least 1 dose of double-blind study therapy, had a baseline value and ≥1 post-baseline value for this outcome. Data after initiation of additional AHA were treated as missing. For FAS with no data at Week 18, the last post-baseline observed measurement was carried forward to Week 18.||Participants|||Number
741813|NCT00482729|Primary|Change From Baseline in Hemoglobin A1c (A1C) at Week 18|A1C is measured as percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.|Baseline and Week 18|The Full Analysis Set (FAS) included all patients who received at least 1 dose of double-blind study therapy, had a baseline value and ≥ 1 post-baseline value for this outcome. Data after initiation of additional AHA were treated as missing. For FAS with no data at Week 18, the last post-baseline observed measurement was carried forward to Week 18.||Percent||95% Confidence Interval|Least Squares Mean
741814|NCT00482911|Secondary|Changes in Gene Expression, Methylation and Protein Modification|Ribonucleic acid (RNA), deoxyribonucleic acid (DNA) and protein obtained from blood, urine and/or tissue was to be evaluated for changes in gene expression, methylation and/or protein modification.|Baseline and end of treatment course 1 and 2, approximately 42 days|Overall survival is not the same as response, to obtain overall survival the investigator would have to follow patients until death, which the original investigator left the institution well before this outcome could be accomplished|||||
741815|NCT00482911|Secondary|Progression Free Survival|Proportion of patients who progress or die after the start of treatment|up to 16 months|Overall survival is not the same as response, to obtain overall survival the investigator would have to follow patients until death, which the original investigator left the institution well before this outcome could be accomplished|||||
741816|NCT00482911|Primary|Overall Survival|Time from date of on study to the date of death from any cause or last follow up|up to 16 months|Overall survival is not the same as response, to obtain overall survival the investigator would have to follow patients until death, which the original investigator left the institution well before this outcome could be accomplished.|||||
741817|NCT00482911|Primary|Toxicity|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|16 months|Cohort 2 = 9 patients. Two patients received Dose B-QD in cycle 1 as outlined in participant flow. Seven patients received Dose D-QD in cycle 1 as outlined in participant flow.||Participants|||Number
741818|NCT00482911|Primary|Response Rate (Complete and Partial Response)|Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is the disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.|2 years|Cohort 2 = 9 patients. Two patients received Dose B-QD in cycle 1 as outlined in participant flow. Seven patients received Dose D-QD in cycle 1 as outlined in participant flow.||Participants|||Number
741819|NCT00483002|Primary|Percentage of Participants With 7-day Point Prevalence for at Least Week 11|Treatment effectiveness was measured by 7-day point prevalence of smoking abstinence status. The smoking status was categorized as smoking or abstained smoking based on 2 parameters: if participant smoked any cigarettes (even a puff) in the last 7 days (Yes/No); if participant used any other nicotine-containing products in the last 7 days (Yes/No).|At least Week 11|Study population included all those participants who received the study medication more than once and were available for follow up. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.||Percentage of participants||95% Confidence Interval|Number
741820|NCT00483002|Primary|Percentage of Participants With 7-day Point Prevalence From Week 7 to Less Than Week 11|Treatment effectiveness was measured by 7-day point prevalence of smoking abstinence status. The smoking status was categorized as smoking or abstained smoking based on 2 parameters: if participant smoked any cigarettes (even a puff) in the last 7 days (Yes/No); if participant used any other nicotine-containing products in the last 7 days (Yes/No).|Week 7 through Week 11|Study population included all those participants who received the study medication more than once and were available for follow up. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.||Percentage of participants||95% Confidence Interval|Number
741821|NCT00483002|Primary|Percentage of Participants With 7-day Point Prevalence From Week 3 to Less Than Week 7|Treatment effectiveness was measured by 7-day point prevalence of smoking abstinence status. The smoking status was categorized as smoking or abstained smoking based on 2 parameters: if participant smoked any cigarettes (even a puff) in the last 7 days (Yes/No); if participant used any other nicotine-containing products in the last 7 days (Yes/No).|Week 3 through Week 7|Study population included all those participants who received the study medication more than once and were available for follow up. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.||Percentage of participants||95% Confidence Interval|Number
741822|NCT00483041|Secondary|Volume at Distribution (Vz)|Vz of MEDI-528|Days 0, 1, 7, 14, 15, 28, 56, 84, and 126|All participants who were randomized (n=11), received MEDI-528 (n=5), and had pharmacokinetic samples for analysis (n=4)||Milliliter||Geometric Coefficient of Variation|Geometric Mean
741823|NCT00483041|Secondary|Volume at Steady State (Vss)|Vss of MEDI-528|Days 0, 1, 7, 14, 15, 28, 56, 84, and 126|All participants who were randomized (n=11), received MEDI-528 (n=5), and had pharmacokinetic samples for analysis (n=4)||Milliliter||Geometric Coefficient of Variation|Geometric Mean
741824|NCT00483041|Secondary|Terminal Half-life (T1/2)|T1/2 of MEDI-528|Days 0, 1, 7, 14, 15, 28, 56, 84, and 126|All participants who were randomized (n=11), received MEDI-528 (n=5), and had pharmacokinetic samples for analysis (n=4)||Day||Geometric Coefficient of Variation|Geometric Mean
741825|NCT00483041|Secondary|Clearance (CL)|CL of MEDI-528|Days 0, 1, 7, 14, 15, 28, 56, 84, and 126|All participants who were randomized (n=11), received MEDI-528 (n=5), and had pharmacokinetic samples for analysis (n=4)||Milliliters per day||Geometric Coefficient of Variation|Geometric Mean
741826|NCT00483041|Secondary|Percent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)]|AUC(ext) of MEDI-528|Days 0, 1, 7, 14, 15, 28, 56, 84, and 126|All participants who were randomized (n=11), received MEDI-528 (n=5), and had pharmacokinetic samples for analysis (n=4)||Percentage of Total Area||Geometric Coefficient of Variation|Geometric Mean
741827|NCT00483041|Secondary|Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)]|AUC(0-infinity) of MEDI-528|Days 0, 1, 7, 14, 15, 28, 56, 84, and 126|All participants who were randomized (n=11), received MEDI-528 (n=5), and had pharmacokinetic samples for analysis (n=4)||Microgram times day per milliliter||Geometric Coefficient of Variation|Geometric Mean
741828|NCT00483041|Secondary|Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)]|AUC(0-t) of MEDI-528|Days 0, 1, 7, 14, 15, 28, 56, 84, and 126|All participants who were randomized (n=11), received MEDI-528 (n=5), and had pharmacokinetic samples for analysis (n=4)||Microgram times day per milliliter||Geometric Coefficient of Variation|Geometric Mean
741829|NCT00483041|Secondary|Peak Concentration (Cmax)|Cmax of MEDI-528|Days 0, 1, 7, 14, 15, 28, 56, 84, and 126|All participants who were randomized (n=11), received MEDI-528 (n=5), and had pharmacokinetic samples for analysis (n=4)||Microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
741830|NCT00483041|Secondary|Time to Peak Concentration (Tmax)|Tmax of MEDI-528|Days 0, 1, 7, 14, 15, 28, 56, 84, and 126|All participants who were randomized (n=11), received MEDI-528 (n=5), and had pharmacokinetic samples for analysis (n=4)||Day||Geometric Coefficient of Variation|Geometric Mean
741831|NCT00483041|Secondary|Incidence of Anti-drug Antibodies (ADA) to MEDI-528|Number of participants with ADA to MEDI-528|Days 0, 28, 56, 84, and 126|All participants who were randomized (n=11) and received at least one dose of investigational product (MEDI-528 or placebo; n=10). One subject in the 9 mg/kg group had no sample collected on Day 126.||Participants|||Number
741832|NCT00483041|Secondary|Incidence of Serious Adverse Events|Number of participants experiencing serious adverse events|Days 0 - 126|All participants who were randomized (n=11) and received at least one dose of investigational product (MEDI-528 or placebo; n=10).||Participants|||Number
741833|NCT00483041|Secondary|Incidence of Adverse Events|Number of participants experiencing adverse events (includes both adverse events and serious adverse events)|Days 0 - 126|All participants who were randomized (n=11) and received at least one dose of investigational product (MEDI-528 or placebo; n=10).||Participants|||Number
741834|NCT00483041|Primary|Listing of Total Interleukin-9 (IL-9) Counts by Enzyme-linked Immunosorbent Assay in Bronchoalveolar Lavage Fluid (BAL)|The response of biologically active IL-9 in BAL fluid to the segmental allergen challenge, 1-2 days after the applying the allergen, prior to and 2 weeks after investigational product administration.|Baseline (2 to 4 weeks prior to Day 0) and Day 15|All subjects who were randomized (n=11), received at least one dose of investigational product (MEDI-528 or placebo; n=10), and completed the 2-day BAL and segmental allergen challenge procedures at baseline (2-4 weeks prior to Day 0) and on Days 14 and 15 (n=2; 1 subject in each treatment group).||Picograms per milliliter|||Number
741835|NCT00483119|Secondary|Ability to be Weaned Off Steroids||Measured 6 and 10 weeks after initiation of IVIg treatment|Sadly, the trial PI, Dr. Jean-Claude Bystryn, died on August 19, 2010. As a result the study could not be completed and an analysis of the data collected was not performed.|||||
741836|NCT00483119|Secondary|Toxicity of Treatment: Measured in Renal Toxicity, Myelosuppression or Hepatic Toxicity||Throughout course of study|Sadly, the trial PI, Dr. Jean-Claude Bystryn, died on August 19, 2010. As a result the study could not be completed and an analysis of the data collected was not performed.|||||
741837|NCT00483119|Primary|Serum Levels of Pemphigus Antibodies||6-10 weeks after initiation of therapy|Sadly, the trial PI, Dr. Jean-Claude Bystryn, died on August 19, 2010. As a result the study could not be completed and an analysis of the data collected was not performed.|||||
741838|NCT00483119|Primary|Clinical Outcome: Extent and Severity of Disease||6 - 10 weeks after initiation of therapy|Sadly, the trial PI, Dr. Jean-Claude Bystryn, died on August 19, 2010. As a result the study could not be completed and an analysis of the data collected was not performed.|||||
741839|NCT00483184|Secondary|Time to Initial Response, Oral Ulcer Sustained Response, Oral Ulcer Recurrence, Time to Recurrence, Pain Associated With Oral Lesions, General Well-Being, Safety||12 weeks||||||
741840|NCT00483184|Primary|Comparison of Patients Experiencing a Sustained Response for Each Treatment Arm.|A patient with a 75% or greater decrease in total OU for three visits was considered a “sustained responder”.|(0-12 weeks)|||patients with sustained response|||Number
741841|NCT00483223|Secondary|Progression Free Survival and Overall Survival|Median progression free survival and overall survival (progression determined using RECIST) during a median follow-up time of 50 months.|5 years|||Months||Full Range|Median
741842|NCT00483223|Secondary|Objective Response Rate Categorized by Subgroup|The number of participants achieving an objective response (as determined by RECIST) categorized by treatment cohort and whether the treatment was first or second line treatment. First line treatment means that the drug used was the first drug used for the treatment of the primary cancer. Second line treatment means that a first line treatment failed to produce the desired response, so a new drug was used for treatment.|3 years|Response rate is divide by drug cohort and categorized by first or second-line treatment||Participants|||Count of Participants
741843|NCT00483223|Primary|Response Rate Categorized by p63/p73 Ratio|Response rate categorized by pre-specified ΔNp63/TAp73 expression ratio cutoff in the primary tumors from this patient cohort as a bio-marker to predict response to cisplatin or carboplatin. Response is defined as partial or completed response as determined by RECIST. Expression ratio was measured using quantitative RT-PCR (Reverse transcription polymerase chain reaction).|3 years|Patients from either cohort with a tumor sample available to evaluate for expression ratio.||Participants|||Count of Participants
741844|NCT00483223|Primary|Objective Response Rate|"Objective response rate (ORR) (complete response [CR]+ partial response [PR]) by RECIST (Response Evaluation Criteria In Solid Tumors).
Complete Response (CR): Disappearance of all target lesions
Partial Response (PR): At least a 30% decrease in the sum of the LD (longest diameter) of target lesions, taking as reference the baseline sum LD
Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started
Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions"|3 years|||Participants|||Count of Participants
741850|NCT00483327|Secondary|Toxicity and Tolerability|Patients with adverse events (AEs) which were possibly, probably, or definitely related to the treatment. AEs were evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) 3.|up to 36 months|Any patient with at least one dose of treatment.||participants|||Number
741851|NCT00483327|Primary|Best Pathologic Responses|Patients are evaluated every 12 weeks while on treatment. The response is evaluated by endometrial biopsy or dilation and curettage (D&C)/hysteroscopy. Complete response (CR) is defined as endometrial sampling is read as normal or proliferative endometrium. Partial response (PR) is defined as the biopsy sample has changed on the endometrial evaluation scale by at least one level towards normal. Stable disease (SD) is defined as no change in pathology between the index and follow-up sample. Progressive disease (PD) is defined the follow-up sample has changed towards neoplasia on the endometrial evaluation scale by at least one level or imaging is concerning for myometrial invasion or extrauterine disease such that conservative management is no longer medically appropriate.|up to 24 months|Patient who were able to complete at least one full course (12 weeks) of treatment||participants|||Number
741852|NCT00477334|Secondary|The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment|"The number of participants with clinically noted shifts in Clinical Chemistry tests from normal at baseline are graded based on Division of Microbiology and Infectious Diseases (DMID) toxicity tables from Grade 1 toxicity (smallest change) to Grade 4 toxicity (largest change). Grade 3 and 4 toxicities are considered to be clinically meaningful.
SGPT(ALT)= Serum Glutamic Pyruvate Transaminase (Alanine Aminotransferase) and SGOT(AST)= Serum Glutamic Oxalacetic Transaminase (Aspartate Aminotransferase)"|Baseline, Day 2|304 Participants = 206 participants in the Famciclovir Group + 98 participants in the Placebo Group. Individual n values in each of the categories is the number of participants in the group with normal baseline values and at least one non-missing post baseline measurement.||Participants|||Number
741853|NCT00477334|Secondary|The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Hematology Test and Treatment|The number of participants with clinically noted shifts in Hematology tests from normal at baseline are graded based on Division of Microbiology and Infectious Diseases (DMID) toxicity tables from Grade 1 toxicity (smallest change) to Grade 4 toxicity (largest change). Grade 3 and 4 toxicities are considered to be clinically meaningful.|Baseline, Day 2|304 Participants = 206 participants in the Famciclovir Group + 98 participants in the Placebo Group. Individual n values in each of the categories is the number of participants in the group with normal baseline values and at least one non-missing post baseline measurement.||Participants|||Number
741854|NCT00477334|Secondary|Time to Second Recurrence of Genital Herpes|Kaplan Meier estimated time in days to second recurrent from treatment initiation and from the date of healing of aborted lesions.|6 months|Intent to Treat Population: participants who completed the first recurrence.||Days||Inter-Quartile Range|Median
741855|NCT00477334|Secondary|Number of Participants With a Second Recurrence of Genital Herpes in the Follow-up Period|Number of participants with a second recurrence of genital herpes in the follow-up period.|6 months|Intent to Treat Population: participants who completed the first recurrence.||Participants|||Number
741856|NCT00477334|Secondary|Time to Resolution of Symptoms Associated With Recurrent Genital Herpes|Median time to resolution of symptoms: all symptoms, pain, burning, itching, tingling and tenderness associated with recurrent genital herpes estimated using Kaplan-Meier method.|72 hour after initiation of study medication up to 21 days|Intent to Treat Population. If a participant never had a symptom prior to the last valid diary entry for the first recurrence, then the time to resolution of the symptom was set to missing and the participant was not included in the analysis.||Days||Inter-Quartile Range|Median
741857|NCT00477334|Secondary|Investigator Assessed Time to Healing of All Non-aborted and Aborted Genital Herpes Lesions|Kaplan-Meier estimation.|21 days|ITT participants who discontinued from the study before healing of non aborted lesions was confirmed and participants who completed the study after 21 days since treatment initiation without non aborted lesion stages and without a final assessment on aborted lesion status were assumed as having non aborted lesions in this analysis.||Days||Inter-Quartile Range|Median
741858|NCT00477334|Secondary|Percentage of Participants With Aborted and Non-aborted Genital Herpes Lesions During the Treatment Period||21 days|Intent-to-Treat (ITT). All randomized participants who initiated treatment (i.e. received any dose of the study drug) with the intention of treating genital herpes recurrences.||Percentage of Participants|||Number
741859|NCT00477334|Primary|Investigator Assessed Time to Healing of All Non-aborted Genital Herpes Lesions|Time to healing of all non-aborted genital herpes lesions, defined as the time from the first dose of study medication to the investigator-assessed time of healing (i.e. loss of all crusts and re-epithelialization of lesions; erythema may be present).|21 days|Modified Intent to Treat Population (mITT) that includes all Intent to Treat participants with non-aborted genital herpes lesions during the treatment period.||Days||Inter-Quartile Range|Median
741860|NCT00477386|Secondary|Phase II: Progression Free Survival|Progression free survival times will be estimated using the Kaplan-Meier method. If a patient progresses or dies, the time till that event will be used. If a patient does not progress or die on the study, the patient will be censored at the last available visit. Confidence intervals on the median will be constructed.|Baseline until disease progression or last visit|All Patients in Phase II of the study||Months||95% Confidence Interval|Median
741861|NCT00477386|Secondary|Phase II: Percent of Patients With Objective Response, CA125 Response or Stable Disease > 3 Months|The percent of patients having an objective response (Complete Response or Partial Response) or CA125 response (Complete Response or Partial Response) or stable disease > 3 months will be estimated with a 95% exact binomial confidence interval for the percent of patients receiving drug.|screening until end of study (approx 12-18 months)|All Patients in Phase II of the study||percent of patients||95% Confidence Interval|Number
741862|NCT00477386|Primary|Phase II: Percent of Patients With Objective Response|The percent of patients having an objective response (Complete Response or Partial Response) will be estimated with a 95% exact binomial confidence interval for the percent of patients receiving drug.|screening until end of study (approx 12-18 months)|All Patients in Phase II of the study||percent of participants||95% Confidence Interval|Number
741910|NCT00483379|Secondary|Baseline Values for Left Ventricular Mass Index (LVMI)|Cardiac pathophysiology was assessed by a central cardiologist using left ventricular mass index (LVMI) measured by echocardiogram at Baseline. Left Ventricular Mass is adjusted to the participant's body surface area in the calculation of LVMI.|Day 0|Full analysis population of participants with LVMI data||g/m^2||Full Range|Median
741863|NCT00477386|Primary|Phase I: Maximum Tolerated Dose (MTD) for Use in Phase II|The definition of MTD will follow the standard definition of the phase I 3+3 trial concept. Dose Limiting Toxicities (DLTs) will be scored in the first cycle. Patients will be monitored for 28 days (a cycle) to determine whether a DLT is experienced for the specific dose level.|28 days|All patients assigned to Phase I of the study||mg/m2 IV QD x 5 days|||Number
741864|NCT00477451|Secondary|Borg Max Change From Baseline|"Subjects asked to Point to the number (0 to 10) which matches how breathless you feel now where 0=nothing at all to 10=very, very strong"|45 minutes|RCT Population (N=40)||units on a scale||Standard Deviation|Mean
741865|NCT00477451|Primary|Duration of the Doxapram-induced Panic Attack|Length of time from the doxapram injection to the time at which the acute panic inventory (API) value returns to within 10 points of the baseline API value. 0=never exceeded 0, 61=exceeded by more than 10 points still at end of assessment of 60 minutes. Thus each would have a duration whether or not they had a panic attack (DIPASI)|1 hr post-dose|RCT Population (N=40)||minutes||Standard Deviation|Mean
741866|NCT00477451|Primary|Number of Participants With Doxapram-induced Panic Attack|doxapram-induced panic attack of sufficient intensity (DIPASI) defined as a 10 or greater increase from baseline in the acute panic inventory (API)|0 to 2 hours|RCT Population (N=40)||Participants|||Count of Participants
741867|NCT00477464|Secondary|Trough Concentration of Capecitabine, 5-FU, and FBAL|PK samples were collected at pre-dose on Day 14 (minus 2 days). Trough concentration is defined as the minimum serum concentration at steady state after a repeated dose. 5-FU and FBAL were evaluated because of the following reasons: (1) capecitabine is an orally administered fluoropyrimidine carbamate selectively activated to fluorouracil (5-FU) in tumors; (2) FBAL is an inactive major metabolite of capecitabine, and metabolites of capecitabine are excreted mainly in urine.|Week 2|ITT Population. Evaluable samples were not taken from some participants.||ng/ml||Standard Deviation|Mean
741868|NCT00477464|Secondary|Trough Concentration of Lapatinib|PK samples were collected at pre-dose on Day 14 and Day 21 (minus 2 days). Trough concentration is defined as the minimum serum concentration at steady state after a repeated dose of lapatinib.|Week 2|ITT Population. Evaluable samples were not taken from some participants.||ng/ml||Standard Deviation|Mean
741869|NCT00477464|Secondary|Area Under the Plasma Concentration-time Curve From Zero to 12 Hours (AUC0-12) of Capecitabine, 5'-Fluorouracil (5-FU), and Alpha-fluoro-beta-alanine (FBAL)|PK samples were collected at pre-dose, and at 0.5 (plus or minus 5 minutes), 1, 2, 3, 4 (plus or minus 15 minutes), 6, 8, and 10 hr (plus or minus 30 minutes) after dosing. AUC is defined as the area under the concentration-time curve from 0 to 12 hours after dosing (AUC 0-12). 5-FU and FBAL were evaluated because of the following reasons: (1) capecitabine is an orally administered fluoropyrimidine carbamate selectively activated to fluorouracil (5-FU) in tumors; (2) FBAL is an inactive major metabolite of capecitabine, and metabolites of capecitabine are excreted mainly in urine.|Week 2|PK Population. One participant was excluded due to dose reduction.||hr*ng/ml||95% Confidence Interval|Geometric Mean
741870|NCT00477464|Secondary|AUC0-tau of Capecitabine, 5'-Fluorouracil (5-FU), and Alpha-fluoro-beta-alanine (FBAL)|PK samples were collected at pre-dose, and at 0.5 (plus or minus 5 minutes), 1, 2, 3, 4 (plus or minus 15 minutes), 6, 8, and 10 hr (plus or minus 30 minutes) after dosing. AUC is defined as the area under the concentration-time curve from 0 to last quantifiable concentration (AUC 0-tau). 5-FU and FBAL were evaluated because of the following reasons: (1) capecitabine is an orally administered fluoropyrimidine carbamate selectively activated to fluorouracil (5-FU) in tumors; (2) FBAL is an inactive major metabolite of capecitabine, and metabolites of capecitabine are excreted mainly in urine.|Week 2|PK Population. One participant was excluded due to dose reduction.||hr*ng/ml||95% Confidence Interval|Geometric Mean
741871|NCT00477464|Secondary|t1/2 of Capecitabine, 5'-Fluorouracil (5-FU), and Alpha-fluoro-beta-alanine (FBAL)|Terminal elimination half-life is defined as the duration until observation of half of the maximum concentration. PK samples were collected at pre-dose, and at 0.5 (plus or minus 5 minutes), 1, 2, 3, 4 (plus or minus 15 minutes), 6, 8, and 10 hr (plus or minus 30 minutes) after dosing. 5-FU and FBAL were evaluated because of the following reasons: (1) capecitabine is an orally administered fluoropyrimidine carbamate selectively activated to fluorouracil (5-FU) in tumors; (2) FBAL is an inactive major metabolite of capecitabine, and metabolites of capecitabine are excreted mainly in urine.|Week 2|PK Population. One participant was excluded due to dose reduction.||hr||95% Confidence Interval|Geometric Mean
741872|NCT00477464|Secondary|Tmax of Capecitabine, 5'-Fluorouracil (5-FU), and Alpha-fluoro-beta-alanine (FBAL)|PK samples were collected at pre-dose, and at 0.5 (plus or minus 5 minutes), 1, 2, 3, 4 (plus or minus 15 minutes), 6, 8, and 10 hr (plus or minus 30 minutes) after dosing. Tmax is defined as the time to peak concentration from initiation of dosing. 5-FU and FBAL were evaluated because of the following reasons: (1) capecitabine is an orally administered fluoropyrimidine carbamate selectively activated to fluorouracil (5-FU) in tumors; (2) FBAL is an inactive major metabolite of capecitabine, and metabolites of capecitabine are excreted mainly in urine.|Week 2|PK Population. One participant was excluded due to dose reduction.||hr||95% Confidence Interval|Geometric Mean
741873|NCT00477464|Secondary|Cmax of Capecitabine, 5'-Fluorouracil (5-FU), and Alpha-fluoro-beta-alanine (FBAL)|PK samples were collected at pre-dose, and at 0.5 (plus or minus 5 minutes), 1, 2, 3, 4 (plus or minus 15 minutes), 6, 8, and 10 hr (plus or minus 30 minutes) after dosing. Cmax is defined as the maximum concentration of drug. 5-FU and FBAL were evaluated because of the following reasons: (1) capecitabine is an orally administered fluoropyrimidine carbamate selectively activated to fluorouracil (5-FU) in tumors; (2) FBAL is an inactive major metabolite of capecitabine, and metabolites of capecitabine are excreted mainly in urine.|Week 2|PK Population. One participant was excluded due to dose reduction.||ng/ml||95% Confidence Interval|Geometric Mean
741874|NCT00477464|Secondary|Area Under the Plasma Concentration-time Curve From Zero to 24 Hours AUC0-24 of Lapatinib|PK samples were collected at pre-dose, and at 1, 2, 3, 4 (plus or minus 15 minutes), 6, 8, 10, 12, and 24 hr (plus or minus 30 minutes) after dosing. AUC is defined as the area under the concentration-time curve from 0 to 24 hour after dosing (AUC 0-24). AUC is a measure of exposure.|Week 2|PK Population. One participant was excluded due to dose reduction.||hr*ng/ml||95% Confidence Interval|Geometric Mean
741944|NCT00489489|Secondary|Pharmacokinetic [PK]: Teriflunomide Plasma Concentration|Plasma concentrations of teriflunomide were measured using validated liquid chromatography-tandem mass spectrometry methods.|24 weeks|All randomized and treated participants who had at least one PK sample. Participants were included in the treatment group according to the drug actually received.||micrograms/mililiter (μg/mL)||Standard Deviation|Mean
741875|NCT00477464|Secondary|Area Under the Plasma Concentration-time Curve Within the Dosing Interval AUC0-tau of Lapatinib|PK samples were collected at pre-dose, and at 1, 2, 3, 4 (plus or minus 15 minutes), 6, 8, 10, 12, and 24 hr (plus or minus 30 minutes) after dosing. AUC is defined as the area under the concentration-time curve from 0 to last quantifiable concentration (AUC 0-tau). AUC is a measure of exposure.|Week 2|PK Population. One participant was excluded due to dose reduction.||hr*ng/ml||95% Confidence Interval|Geometric Mean
741876|NCT00477464|Secondary|Terminal Elimination Half-life (t1/2) of Lapatinib|Terminal elimination half-life is defined as the duration until observation of half of the maximum concentration. PK samples were collected at pre-dose, and at 1, 2, 3, 4 (plus or minus 15 minutes), 6, 8, 10, 12, and 24 hr (plus or minus 30 minutes) after dosing.|Week 2|PK Population. One participant was excluded due to dose reduction.||hr||95% Confidence Interval|Geometric Mean
741877|NCT00477464|Secondary|Time to Maximum Plasma Concentration (Tmax) of Lapatinib|PK samples were collected at pre-dose, and at 1, 2, 3, 4 (plus or minus 15 minutes), 6, 8, 10, 12, and 24 hr (plus or minus 30 minutes) after dosing. Tmax is defined as the time to peak concentration from initiation of lapatinib dosing.|Week 2|PK Population. One participant was excluded due to dose reduction.||hr||95% Confidence Interval|Geometric Mean
741878|NCT00477464|Secondary|Maximum Plasma Concentration (Cmax) of Lapatinib|Pharmacokinetic (PK) samples were collected at pre-dose, and at 1, 2, 3, 4 (plus or minus 15 minutes), 6, 8, 10, 12, and 24 hours (hr) (plus or minus 30 minutes) after dosing. Cmax is defined as the maximum concentration of lapatinib.|Week 2|PK Population: consisted of the first six participants who were enrolled into the study and evaluable for the PK parameters of the investigational products. One participant was excluded due to dose reduction.||nanograms/milliliter (ng/ml)||95% Confidence Interval|Geometric Mean
741879|NCT00477464|Secondary|Duration of Response (Independent Reviewer-assessed)|For the subset of participants who showed a complete or partial response, duration of response is defined as the time from the first documented evidence of partial or complete tumor response until the first documented sign of disease progression or death due to breast cancer, if sooner.|Baseline, every 6 weeks until Week 24 and then every 12 weeks until disease progression or death (up to Week 119)|Participants in the ITT Population achieving a partial or complete response||weeks||95% Confidence Interval|Median
741880|NCT00477464|Secondary|Time to Response (Independent Reviewer-assessed)|Time to response is defined as the time from the start of treatment until the first documented evidence of complete response or partial response.|Baseline, every 6 weeks until Week 24 and then every 12 weeks until disease progression or death (up to Week 119)|Participants in the ITT Population achieving a partial or complete response||weeks||95% Confidence Interval|Median
741881|NCT00477464|Secondary|Overall Survival (Independent Reviewer-assessed)|Overall survival is defined as the time from the start of treatment until death regardless of cause. For participants who did not die, time to death was censored at the time of last confirmation of survival.|Baseline and then followed every 4 weeks until death (up to Week 157.9) while on treatment. After treatment termination, followed every 12 weeks until death (up to Week 157.9)|ITT Population||weeks||95% Confidence Interval|Median
741882|NCT00477464|Secondary|Objective Response (Independent Reviewer-assessed)|Objective response is defined as the percentage of participants achieving a best overall response classified as a complete or partial (confirmed) tumor response. Complete response is defined as the disappearance of all target or non-target lesions, and partial response is defined as at least a 30% decrease in the sum of the longest diameter of target lesions.|Baseline every 6 weeks until Week 24 and then every 12 weeks until disease progression or death (up to Week 119)|ITT Population||percentage of participants|||Number
741883|NCT00477464|Secondary|6-Month Progression-free Survival (Independent Reviewer-assessed)|6-Month progression-free survival is defined as the percentage of participants surviving without progressive disease at 6 months (24 weeks) after the start of treatment. Progressive disease is defined as at least a 20% increase in the sum of the longest diameter of target lesions.|Baseline and then every 6 weeks until Month 6 (Week 24)|ITT Population||percentage of participants|||Number
741884|NCT00477464|Secondary|Progression-free Survival (PFS) (Independent Reviewer-assessed)|PFS is defined as the interval between the start of treatment and the earliest date of disease progression or death of any cause, if sooner.|Baseline, every 6 weeks until Week 24 and then every 12 weeks until disease progression or death (up to Week 119)|ITT Population||weeks||95% Confidence Interval|Median
741885|NCT00477464|Secondary|Time to Progression (Independent Reviewer-assessed)|Time to progression is defined as the interval between the start of treatment and the earliest date of disease progression or death due to breast cancer, if sooner. Time to progression was calculated by using the Kaplan Meier estimate.|Baseline, every 6 weeks until Week 24 and then every 12 weeks until disease progression or death due to breast cancer (up to Week 119)|ITT Population||weeks||95% Confidence Interval|Median
741886|NCT00477464|Primary|Clinical Benefit Response (Independent Reviewer-assessed)|"CBR is defined as the percentage of participants receiving at least one dose of study medication who achieved a best overall response classified as a complete or partial (confirmed) tumor response or stable disease for at least 6 months (24 weeks). A “complete response” is defined as the disappearance of all target or non-target lesions, “partial response” and disease progression as at least a 30% decrease and at least a 20% increase, respectively, in the sum of the longest diameter of target lesions, and “stable disease” as neither “partial response” nor “disease progression.”"|Baseline, every 6 weeks until Week 24 and then every 12 weeks until disease progression (up to Week 119)|Intent-to-treat (ITT) Population: participants who had received at least one dose of study medication.||percentage of participants|||Number
741887|NCT00477490|Secondary|Part II: Participants With Treatment-Emergent Adverse Events (AEs) During Study Part II|A treatment-emergent adverse event (AE) was any AE occurring during the treatment period or a pretreatment AE that worsened in intensity during the treatment period. The treatment period was the period during which a subject received investigational medicinal product. If a subject discontinued the investigational medicinal product, the date of last dose was the last day of the treatment period.|Week 5 up to Day 169|Part II Safety Population includes study participants who received study intervention and had at least one safety assessment during study Part II.||participants|||Number
741986|NCT00489853|Secondary|Inspiratory Capacity (IC) Before Exercise Endurance Time (EET) Performed 1 Hour Postdose|Treatment means from individual participant data.|Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period|||Liter||Standard Deviation|Mean
741888|NCT00477490|Secondary|Part I: Participants With Treatment-Emergent Adverse Events (AEs) During Study Part I|A treatment-emergent adverse event (AE) was any AE occurring during the treatment period or a pretreatment AE that worsened in intensity during the treatment period. The treatment period was the period during which a subject received investigational medicinal product. If a subject discontinued the investigational medicinal product, the date of last dose was the last day of the treatment period.|Day 1 up to Week 4 (end of Part I)|Part I Safety Population includes study participants who received study intervention and had at least one safety assessment during study Part I.||participants|||Number
741889|NCT00477490|Secondary|Part I: Change From Baseline in the Mental Health Summary and the Physical Health Summary of the Short Form-12 Version 2 (SF-12v2) at Week 4|The SF-12v2 was used to measure the impact of nocturia and lack of sleep on general quality of life. The SF-12 consists of 12 questions. Data were analyzed using norm-based scoring and summarized along 2 dimensions: Physical Health Summary and Mental Health Summary. Each summary has a range from 0 (poor health) to 100 (highest level of health). Higher numbers indicate better quality of life.|- Week 3 to Day 1 (Baseline), Week 4 (end of Part I)|Intent to treat population of participants who completed the questionnaire at both baseline and end of Part 1.||units on a scale||Standard Deviation|Mean
741890|NCT00477490|Secondary|Part I: Change From Baseline in Quality of Sleep as Assessed by the Global Score of the Pittsburgh Sleep Quality Index (PSQI) at Week 4|The PSQI is a self-administered 19-item questionnaire designed to assess sleep quality and disturbances. The global score ranges from 0 (better sleep quality) to 21 (worse sleep quality). Higher numbers indicate lower quality of life.|- Week 3 to Day 1 (Baseline), Week 4 (end of Part I)|Intent to treat population of participants who completed the questionnaire at both baseline and end of Part 1.||units on a scale||Standard Deviation|Mean
741891|NCT00477490|Secondary|Part I: Change From Baseline in the Two Domain Scores of the Nocturia Quality of Life (NQoL) Questionnaire at Week 4|The NQoL questionnaire is a self-administered questionnaire designed to assess the impact of nocturia on quality of life. It contains a sleep/energy domain (6 questions), a bother/concern domain (6 questions), and 1 global QoL question. The twelve core questions are scored on a 0 to 4 scale with higher numbers indicating a better quality of life. Domain summary scores were calculated by transforming the raw score into a 0-100 scale with higher numbers indicating a better quality of life.|- Week 3 to Day 1 (Baseline), Week 4 (end of Part I)|Intent to treat population of participants who completed the questionnaire at both baseline and end of Part 1.||units on a scale||Standard Deviation|Mean
741892|NCT00477490|Secondary|Part I: Change From Baseline in Quality of Life Assessed by The International Consultation on Incontinence Modular Questionnaire - Nocturia (ICIQ-N) at Week 4|The ICIQ-N is a self-administered questionnaire designed to assess the frequency and bother of daytime and nighttime urination. Subjects were asked to rate the degree of bother of daytime urination and nighttime urination on a scale ranging from 0 (not at all) to 10 (a great deal). Higher numbers indicate lower quality of life.|- Week 3 to Day 1 (Baseline), Week 4 (end of Part I)|Intent to treat population of participants who completed the questionnaire at both baseline and end of Part 1.||units on a scale||Standard Deviation|Mean
741893|NCT00477490|Secondary|Part I: Change From Baseline in Initial Period of Undisturbed Sleep at Week 4|Initial period of undisturbed sleep was the time elapsed from first falling asleep until either first void or morning arising. Data were captured in patient diaries.|- Week 3 to Day 1 (Baseline), Week 4 (end of Part I)|ITT population --All randomized subjects who received at least one dose of study drug and provided at least one primary efficacy measure (i.e., number of nocturnal voids) during Part I were included in the ITT analysis dataset. Participants with both baseline and Week 4/Day 28/End of Part I data are included.||minutes||Standard Deviation|Mean
741894|NCT00477490|Secondary|Part I: Change From Baseline in Total Reported Sleep Time at Week 4|Total sleep time was recorded by participants in study diaries.|- Week 3 to Day 1 (Baseline), Week 4 (end of Part I)|Intent to treat (ITT) population --All randomized subjects who received at least one dose of study drug and provided at least one primary efficacy measure (i.e., number of nocturnal voids) during Part I were included in the ITT analysis dataset. Participants analyzed had baseline and Week 4/Day 28/End of Part 1 measurements.||minutes||Standard Deviation|Mean
741895|NCT00477490|Secondary|Part II: Percentage of Participants With Greater Than 33 Percent Reduction From Baseline in Mean Number of Nocturnal Voids to Days 29, 57, 113 and 169|Part II outcomes tested the durability of the effect observed in Part I. Percentage of participants in each treatment arm that had a greater than 33% reduction from baseline to Days 29, 57, 113 and 169 in mean number of nocturnal voids. Nocturnal void data were recorded in participant diaries.|- Week 3 to Day 1 (Baseline), Days 29, 57, 113 and 169|Observed Cases (OC) Analysis Set which consisted of participants who had information on mean number of nocturnal voids for both the screening visit and the final visit in Part I (Day 28) and did not have any major protocol deviations. Participants had data representing the visit.||percentage of participants|||Number
741896|NCT00477490|Secondary|Part II: Change From Baseline in Mean Number of Nocturnal Voids to Days 29, 57, 113 and 169|Part II outcomes tested the durability of the effect observed in Part I. The number of nocturnal voids was the average over 3 consecutive 24-hours periods prior to Part I baseline and prior to the Part II visit as recorded in participant diaries.|- Week 3 to Day 1 (Baseline), Days 29, 57, 113 and 169|Observed Cases (OC) Analysis Set which consisted of participants who had information on mean number of nocturnal voids for both the screening visit and the final visit in Part I (Day 28) and did not have any major protocol deviations.||nocturnal voids||Standard Deviation|Mean
741897|NCT00477490|Primary|Part I: Percentage of Participants With Greater Than 33 Percent Reduction From Baseline in Mean Number of Nocturnal Voids at Week 4|"Percentage of participants in each treatment arm that had a greater than 33% reduction from baseline to the end of Part I (week 4) in mean number of nocturnal voids. Nocturnal void data were recorded in participant diaries.
This was the second co-primary outcome."|- Week 3 to Day 1 (Baseline), Week 4 (end of Part I)|Intent to treat (ITT) population --All randomized participants who received at least one dose of study drug and provided at least one primary efficacy measure (i.e., nocturnal voids) during Part I were included in the ITT analysis dataset||percentage of participants|||Number
741987|NCT00489853|Secondary|Borg CR10 Score After Exercise Endurance Time (EET) Performed 6 Hours Post-dose|The level of breathing discomfort experienced by patients, on a scale of 0 (no breathing discomfort at all) to >10 (absolute maximum breathing discomfort). All patients with data are included.|Single measurement performed after exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period|||Scores on a scale||Standard Deviation|Mean
741898|NCT00477490|Primary|Part I: Change From Baseline in Mean Number of Nocturnal Voids at Week 4|"The number of nocturnal voids was the average over 3 consecutive 24-hours periods prior to Day 1 and prior to the week 4 visit as recorded in participant diaries.
This was the first co-primary outcome."|- Week 3 to Day 1 (Baseline), Week 4 (end of Part I)|Intent to treat (ITT) population --All randomized participants who received at least one dose of study drug and provided at least one primary efficacy measure (i.e., nocturnal voids) during Part I were included in the ITT analysis dataset||nocturnal voids||Standard Deviation|Mean
741899|NCT00483379|Primary|Summary of Participants Reporting Treatment-Emergent Adverse Events During the Treatment Period|Overall safety summary of participants experiencing Adverse Events (AEs), Serious Adverse Events (SAEs), treatment-related AEs, and Infusion Associated Reactions (IARs). Summary is based on Treatment-emergent AEs (TEAEs), defined as AEs that occurred following the initiation of study treatment.|Day 1 up to Week 52|Safety population comprised of all participants who received intervention.||participants|||Number
741900|NCT00483379|Primary|Participants' Efficacy Response During the Treatment Period as Compared to Baseline for Participants With Motor Function Decline on Standard Treatment|Participants were enrolled based on clinical decline or sub-optimal clinical response in cardiac, respiratory and/or motor function parameters pre-study while on standard treatment. Each participant was evaluated at Week 52 for change from baseline in the criteria that declined; motor function decline primarily based on Gross Motor Function Measure 66 and Pompe Pediatric Evaluation of Disability Inventory results is summarized. Participants could gain motor function (improve), had no change (declined stopped), or continued loss (worsened). Each participant served as his or her own control.|Baseline, Week 52|All participants who enrolled due to decline in motor function while on standard treatment.||participants|||Number
741901|NCT00483379|Secondary|Change From Baseline in Normative Physical Component Summary of Medical Outcomes Study Short Form Health Survey (SF-36) at Week 52|Health related quality of life is measured using the Physical Component Summary (PCS) score of the Medical Outcomes Study (MOS) Short Form Health Survey (SF-36) for participants ≥14 years of age. SF-36 normative-based scoring has a mean of 50 and a standard deviation of 10. Higher scores represent better quality of life.|Baseline, Week 52|Full analysis population of participants >= 14 years old.||units on a scale||Standard Deviation|Mean
741902|NCT00483379|Secondary|Baseline Values for Normative Physical Component Summary of Medical Outcomes Study Short Form Health Survey (SF-36)|Health related quality of life is measured using the Physical Component Summary (PCS) score of the Medical Outcomes Study (MOS) Short Form Health Survey (SF-36) for participants ≥14 years of age. SF-36 normative-based scoring has a mean of 50 and a standard deviation of 10. Higher scores represent better quality of life.|Day 0|Full analysis population of participants >= 14 years old.||units on a scale||Standard Deviation|Mean
741903|NCT00483379|Secondary|Change From Baseline in Mobility as Measured by the Pompe Pediatric Evaluation of Disability Inventory (Pompe PEDI) at Week 52|The Pompe PEDI is a disease specific version of the PEDI that was developed to assess functional capabilities and performance in children with Pompe disease from 2 months through adolescence. Change from baseline results for the mobility domain are reported. Scaled scores are used as an evaluative measure of change in performance over time with acquisition of new skills or new levels of independence. The range of scores is from 0-100 with scores near “0” reflecting low capability and scores near “100” reflecting high capability.|Baseline, Week 52|Full analysis population||units on a scale||Standard Deviation|Mean
741904|NCT00483379|Secondary|Baseline Values in Mobility as Measured by the Pompe Pediatric Evaluation of Disability Inventory (Pompe PEDI)|"The Pompe PEDI is a disease specific version of the PEDI that was developed to assess functional capabilities and performance in children with Pompe disease from 2 months through adolescence. Baseline results for the mobility domain are reported. Scaled scores are used as an evaluative measure of change in performance over time with acquisition of new skills or new levels of independence. The range of scores is from 0-100 with scores near 0 reflecting low capability and scores near 100 reflecting high capability."|Day 0|Full analysis population||units on a scale||Standard Deviation|Mean
741905|NCT00483379|Secondary|Change From Baseline in Raw Scores for Gross Motor Function Measure 66 (GMFM-66) Results at Week 52|The Gross Motor Function Measure 66 contains sixty-six questions with a total raw score range of 0 - 198. Raw scores are derived from the following dimensions: Lying and rolling = 12; Sitting = 45; Crawling and kneeling = 30; Standing = 39; Walking, running and jumping = 72. Higher scores indicate better gross motor functions.|Baseline, Week 52|Full analysis population||units on a scale||Standard Deviation|Mean
741906|NCT00483379|Secondary|Baseline Values of Raw Scores for Gross Motor Function Measure 66 (GMFM-66) Results|The Gross Motor Function Measure 66 contains sixty-six questions with a total raw score range of 0 - 198. Raw scores are derived from the following dimensions: Lying and rolling = 12; Sitting = 45; Crawling and kneeling = 30; Standing = 39; Walking, running and jumping = 72. Higher scores indicate better gross motor functions.|Day 0|Full analysis population||units on a scale||Standard Deviation|Mean
741907|NCT00483379|Secondary|Change From Baseline in Body Strength Measured by the Manual Muscle Testing (MMT) Total Score at Week 52|Body strength is measured by the MMT score on a scale of 0-10 with higher scores representing greater body strength.|Baseline, Week 52|Full analysis population of participants >= 8 years old. Due to the age restriction and small study population, the number of participants analyzed is too small for results to be meaningful.|||||
741908|NCT00483379|Secondary|Change From Baseline in Ventilator Use at Last Assessment (Approximately Week 52)|The change from baseline in ventilator use at the last assessment is summarized as improved (less use of ventilator support), no change, worsened (increased use of ventilator support), and did not use ventilator support.|Baseline, approximately Week 52|Full analysis population. The participant in the worsened category died after week 52.||participants|||Number
741909|NCT00483379|Secondary|Change From Baseline in Left Ventricular Mass Index (LVMI) at Week 52|Cardiac pathophysiology was assessed by a central cardiologist using left ventricular mass index (LVMI) measured by echocardiogram at Baseline and after 12 months of treatment (Week 52). Left Ventricular Mass is adjusted to the participant's body surface area in the calculation of LVMI.|Baseline, Week 52|Full analysis population of participants with LVMI data at both timepoints||g/m^2||Full Range|Median
742126|NCT00490841|Secondary|9 Month Blood Pressure (Diastolic)|As compared to baseline. See Population description.|9 months and baseline|The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||mmHg||95% Confidence Interval|Mean
741911|NCT00483379|Secondary|Change From Baseline in Left Ventricular Mass (LVM) Z-Score at Week 52|Z-Scores indicate the number of standard deviations (SD) from the mean in a normal distribution. A negative change from baseline indicates a decrease and positive change from baseline an increase in LVM Z-score. The normal range is -2 to 2 and greater than 2 may indicate left ventricular hypertrophy. The Z-scores for all parameters are calculated with reference to the normative data from the Children’s Hospital, Boston, MA (Colan, 1992, J Am Coll Cardiol) based on the reference population with matched body surface area (BSA). Z-scores for LVM were provided by the central cardiologist.|Baseline, Week 52|Full analysis population of participants with LVM data at both timepoints||Z-score||Full Range|Median
741912|NCT00483379|Secondary|Baseline Values for Left Ventricular Mass (LVM) Z-Scores|Z-Scores indicate the number of standard deviations (SD) from the mean in a normal distribution. Negative values indicate a smaller than mean LVM and values higher than 0 indicate a larger LVM than the mean. The normal range is -2 to 2 and greater than 2 may indicate left ventricular hypertrophy. The Z-scores for all parameters are calculated with reference to the normative data from the Children’s Hospital, Boston, MA (Colan, 1992, J Am Coll Cardiol) based on the reference population with matched body surface area (BSA). Z-scores for LVM were provided by the central cardiologist.|Day 0|Full analysis population of participants with LVM data||Z-score||Full Range|Median
741913|NCT00483379|Primary|Participants' Efficacy Response During the Treatment Period as Compared to Baseline for Participants With Respiratory Decline on Standard Treatment|Participants were enrolled based on clinical decline or sub-optimal clinical response in cardiac, respiratory and/or motor function parameters pre-study while on standard treatment. Each participant was evaluated at Week 52 for change from baseline in the criteria that declined; respiratory decline as measured by change in ventilator use is summarized in this outcome. Ventilator use might have improved (less use of ventilator support), had no change, or worsened (more use of ventilator support). Each participant served as his or her own control.|Baseline, Week 52|All participants who enrolled due to decline in respiratory function while on standard treatment.||participants|||Number
741914|NCT00483405|Secondary|Time to Progression|Time to progression will be calculated from the time of enrollment until confirmed disease progression. Defined by RECIST (Response Evaluation Criteria in Solid Tumors), Progressive Disease (PD) – at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.|Median 23 month follow-up|Four patients received some protocol treatment but withdrew before completing one cycle without assessment of response.||months||95% Confidence Interval|Median
741915|NCT00483405|Secondary|Overall Survival|Overall survival will be calculated from time of enrollment to death or last contact date.|Median 23 month follow-up|Four patients received some protocol treatment but withdrew before completing one cycle without assessment of response.||months||95% Confidence Interval|Median
741916|NCT00483405|Secondary|Number of Subjects Experiencing Adverse Events|Adverse events will be assessed using CTCAE criteria.|every 3 weeks of treatment with an average of 15 weeks on treatment|||Participants|||Count of Participants
741917|NCT00483405|Primary|Disease Response Rate|"Radiographic response will be measured every six weeks while subject is on treatment. Response will be measured using RECIST criteria.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions."|42 days (2 cycles)|Four patients received some protocol treatment but withdrew before completing one cycle without assessment of response.||percentage of participants with response||95% Confidence Interval|Number
741920|NCT00483548|Secondary|Change From Baseline in Quality of Life, Enjoyment, and Satisfaction Scale (Q-LES-Q) Scores at Week 6|Q-LES-Q is a 16-item subject rated scale to measure satisfaction with areas of daily functioning (physical health, social relationships, medication, and overall life satisfaction); rated on a 5-point Likert scale: higher scores indicate greater enjoyment and satisfaction with general life activities. Scores for items 1 to 14 are summed for a total score and converted to 0 to 100 range. Items 15 and 16 measure satisfaction with medication and overall satisfaction and are analyzed separately. Change calculated as a difference between post-baseline observation and baseline Q-LES-Q score values.|Baseline, Week 6|ITT; ET visits re-slotted to regular weekly visits according to duration since first dosing date; ET Visit only includes observations from visits that did not meet windowing criteria; (n)=number of subjects with analyzable data at baseline and post-baseline observation for ziprasidone and placebo, respectively.||scores on scale||Standard Deviation|Mean
741921|NCT00483548|Other Pre-specified|Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Scores|AIMS is a clinician rated 12-item scale to rate 7 body areas and global judgments on the severity of abnormal movements, incapacitation and subject's awareness of abnormal movements. Items 1 to 10 scored 0 (none) to 4 (severe); items 11 to 14 are No or Yes response to dental status and sleep movements and are assessed separately. AIMS total score is sum of first 7 items. Change calculated as a difference between post-baseline observation and baseline AIMS score values.|Baseline, Week 2, Week 4, Week 6|ITT; (n)=number of subjects with analyzable data at baseline and post-baseline observation for ziprasidone and placebo, respectively.||scores on scale||Standard Deviation|Mean
744259|NCT00508027|Other Pre-specified|Change in Plasma VEGF Levels|Change in plasma vascular endothelial adhesion molecule-1 levels after treatment with simvastatin|Baseline, 21 days|||pg/mL||Standard Deviation|Mean
741922|NCT00483548|Other Pre-specified|Change From Baseline in Barnes Akathisia Rating Scale (BARS or BAS)|BARS is a clinician rated scale to evaluate akathisia associated with use of antipsychotic medications: objective motor restlessness, range 0 to 3; subjective complaints of restlessness and associated distress, range 0 to 3; global clinical assessment of akathisia, range 0 to 5. Higher scores indicate more affected. Change calculated as a difference between post-baseline observation and baseline BARS score values.|Baseline, Week 2, Week 4, Week 6|ITT; Summarized as Global BARS; individual scores not summarized; (n)=number of subjects with analyzable data at observation for ziprasidone and placebo, respectively.||scores on scale||Standard Deviation|Mean
741923|NCT00483548|Other Pre-specified|Change From Baseline in Simpson Angus Scale (SAS) Score|SAS is a clinician rated 10-item scale to measure extrapyramidal side effects (Parkinsonism or Parkinsonian side effects induced with antipsychotics); rated on a 5-point scale with range 0 (absence of condition) to 4 (presence of condition in extreme form). Global score is sum of all scores divided by the total number of items. Change calculated as a difference between post-baseline observation and baseline SAS score values.|Baseline, Week 2, Week 4, Week 6|ITT; (n)=number of subjects with analyzable data at baseline and post-baseline observation for ziprasidone and placebo, respectively.||scores on scale||Standard Deviation|Mean
741924|NCT00483548|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) at Week 6 (Items 4 and 5)|SDS is a 5-item subject rated scale to measure the extent to which work and or school, social life and or leisure activities, and home life and or family responsibilities were impaired by psychiatric illness. Items 1 to 3 rated on 11-point scale ranging 0 (not at all) to 10 (extremely affected). Total score 0 to 30; higher score indicates greater impairment; items 4 and 5 report number of days in the last month (0 to 31) subject missed work or school or was unproductive and are rated separately. Change calculated as a difference between post-baseline observation and baseline SDS score values.|Baseline, Week 6|ITT; ET visits re-slotted to regular weekly visits according to duration since first dosing date; ET Visit only includes observations from visits that did not meet windowing criteria; (n)=number of subjects with analyzable data at baseline and post-baseline observation for ziprasidone and placebo, respectively.||days||Standard Deviation|Mean
741925|NCT00483548|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) at Week 6 (Items 1 Through 3)|SDS is a 5-item subject rated scale to measure the extent to which work and or school, social life and or leisure activities, and home life and or family responsibilities were impaired by psychiatric illness. Items 1 to 3 rated on 11-point scale ranging 0 (not at all) to 10 (extremely affected). Total score 0 to 30; higher score indicates greater impairment; items 4 and 5 report number of days in the last month (0 to 31) subject missed work or school or was unproductive and are rated separately. Change calculated as a difference between post-baseline observation and baseline SDS score values.|Baseline, Week 6|ITT; ET visits re-slotted to regular weekly visits according to duration since first dosing date; ET Visit only includes observations from visits that did not meet windowing criteria; (n)=number of subjects with analyzable data at baseline and post-baseline observation for ziprasidone and placebo, respectively.||scores on scale||Standard Deviation|Mean
741926|NCT00483548|Secondary|Change From Baseline in Global Assessment of Functioning (GAF) Scale at Week 6|GAF is a clinician rated scale to measure the severity of illness-related impairment in psychological, social, and occupational functioning using a 100-point scale (single score of 1 to 100) with 100 indicating a superior level of function. Change calculated as a difference between post-baseline observation and baseline GAF score values.|Baseline, Week 6|ITT; observed cases; Early Termination (ET) visits re-slotted to regular weekly visits according to duration since first dosing date; ET Visit only includes observations from visits that did not meet windowing criteria; (n)=number of subjects with analyzable data at baseline and post-baseline observation for ziprasidone and placebo, respectively.||scores on scale||Standard Deviation|Mean
741927|NCT00483548|Secondary|Change From Baseline in Young Mania Rating Scale (YMRS) Total Score|YMRS is clinician rated 11-item scale (elevated mood, increased motor activity-energy, sexual interest, sleep, irritability, speech [rate and amount], language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight) used to assess the severity of manic symptoms and effect of treatment on mania severity. Seven items ranked on scale from 0 to 4; 4 items ranked 0 to 8. Higher scores indicate greater severity. Change calculated as a difference between post-baseline observation and baseline YMRS score values. Week 6 is the primary timepoint.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6|ITT; LOCF; (n)=number of subjects with analyzable data at baseline and post-baseline observation for ziprasidone and placebo, respectively.||scores on scale||Standard Deviation|Mean
741928|NCT00483548|Secondary|Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score|HAM-A is a clinician rated 14-item scale that rates the intensity of psychic anxiety (items 1 to 6 and item 14) and somatic anxiety (items 7 to 13) on a 5-point severity scale; scores range from 0 (not present) to 4 (very severe); lower score indicates less affected. Change calculated as a difference between post-baseline observation and baseline HAM-A score values. Week 6 is the primary timepoint.|Baseline, Week 2, Week 4, Week 6|ITT; LOCF; (n)=number of subjects with analyzable data at baseline and post-baseline observation for ziprasidone and placebo, respectively.||scores on scale||Standard Deviation|Mean
741929|NCT00483548|Secondary|CGI-Improvement Score|CGI-I is a single-item clinician rated scale used to assess global improvement in the subject's clinical state (bipolar mania) in response to study treatment and as compared to their status at pre-treatment baseline. Scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse). Higher score = more affected. Week 6 is the primary timepoint.|Week 1, Week 2, Week 3, Week 4, Week 5, Week 6|ITT; LOCF; (n)=number of subjects with analyzable data at baseline and post-baseline observation for ziprasidone and placebo, respectively.||scores on scale||Standard Deviation|Mean
741930|NCT00483548|Secondary|Change From Baseline in CGI-Severity Score (Post-baseline Excluding Week 6)|CGI-S is a single-item clinician rated scale used to assess global severity of bipolar illness based on an overall evaluation of symptoms of bipolar mania, associated behavioral symptoms, and condition of the subject. Scores range from 1 (normal, not at all ill) to 7 (among the most severely ill subjects). Higher score = more affected. Change calculated as a difference between post-baseline observation and baseline CGI-S score values.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5|ITT; LOCF; (n)=number of subjects with analyzable data: baseline and post-baseline observation for ziprasidone, placebo, respectively.||scores on scale||Standard Deviation|Mean
744260|NCT00508027|Other Pre-specified|Change in Plasma IL-6 Levels|Change in plasma IL-6 level after treatment with simvastatin|Baseline, 21 days|||pg/mL||Standard Deviation|Mean
741931|NCT00483548|Secondary|Change From Baseline in MADRS Total Score (Post-baseline Excluding Week 6)|MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts); rated on a 7-point Likert scale 0 (normal) to 6 (most abnormal); total score 0 to 44 (higher score indicates greater severity of symptoms). Change calculated as a difference between post-baseline observation and baseline MADRS score values.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5|ITT; LOCF; (n)=number of subjects with analyzable data: baseline and post-baseline observation for ziprasidone, placebo, respectively.||scores on scale||Standard Deviation|Mean
741932|NCT00483548|Secondary|Clinical Global Impression - Improvement Scale (CGI-Improvement or CGI-I): Number of Subjects With Response (Much Improved or Very Much Improved) at Week 6|Number of subjects with improvement defined as CGI-I response of 1 (very much improved) or 2 (much improved). CGI-I is a single-item clinician rated scale used to assess global improvement in the subject's clinical state (bipolar mania) in response to study treatment and as compared to their status at pre-treatment baseline. Scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse). Higher score = more affected.|Baseline, Week 6|ITT; LOCF||participants|||Number
741933|NCT00483548|Secondary|MADRS Response: Number of Subjects With Total MADRS Score Reduction ≥ 50 Percent From Baseline at Week 6|Number of subjects with reduction of ≥50 percent (%) in MADRS total score (indicates response). MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts); rated on a 7-point Likert scale 0 (normal) to 6 (most abnormal); total score 0 to 44 (higher score indicates greater severity of symptoms). Reduction calculated as ([A-B]/B*100): A=value at observation; B=baseline value.|Week 6|ITT; LOCF||participants|||Number
741934|NCT00483548|Secondary|MADRS Remission: Number of Subjects With Total MADRS Score ≤ 12 at Week 6|Number of subjects with MADRS total score ≤ 12 (indicates remission). MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts); rated on a 7-point Likert scale 0 (normal) to 6 (most abnormal); total score 0 to 44 (higher score indicates greater severity of symptoms).|Week 6|ITT; Last observation carried forward (LOCF)||participants|||Number
741935|NCT00483548|Secondary|Change From Baseline to Week 6 in Clinical Global Impression - Severity Scale (CGI-Severity or CGI-S)|CGI-S is a single-item clinician rated scale used to assess global severity of bipolar illness based on an overall evaluation of symptoms of bipolar mania, associated behavioral symptoms, and condition of the subject. Scored from 1 (normal, not at all ill) to 7 (among the most severely ill subjects). Higher score = more affected. Change calculated as a difference between post-baseline observation and baseline CGI-S score values.|Baseline, Week 6|ITT||scores on scale||Standard Deviation|Mean
741936|NCT00483548|Primary|Change From Baseline to Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts); rated on a 7-point Likert scale 0 (normal) to 6 (most abnormal); total score 0 to 44 (higher score indicates greater severity of symptoms). Change calculated as a difference between post-baseline observation and baseline MADRS score values.|Baseline, Week 6|Intent to Treat analysis set (ITT): all randomized subjects who received at least 1 dose of double-blind treatment and had at least 1 post-baseline primary efficacy evaluation.||scores on scale||Standard Deviation|Mean
741937|NCT00483574|Other Pre-specified|Safety Overview After Any Vaccination in Participants Who Received MMR+V||Day 0 to 7 Post-vaccination|Summary of the safety analysis of the 23 participants in Group 1 that received MMR+V vaccines instead of a MMRV single vaccine in addition to the PCV and HepA vaccines.||Percentage of participants|||Number
741938|NCT00483574|Primary|Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination.|"Solicited injection site reactions: tenderness, Erythema (Redness), and Swelling.
Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, and Irritability"|Day 0 to 7 Post-vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population. Data on 23 participants in Group 1 that received MMR+V vaccines instead of a MMRV single vaccine in addition to the PCV and HepA vaccines were analyzed separately.||Percentage of participants|||Number
741939|NCT00483652|Secondary|Change in Lower Extremity Manual Muscle Test [LEMMT]|Evaluator rated strength in hip flexors, knee flexors, knee extensors, and ankle dorsiflexors on the following scale: best value = 5.0 (normal muscle strength), worst value = 0.0 (absence of any voluntary contraction). A positive shift in LEMMT score shows improvement in strength. Change in LEMMT scores for the secondary efficacy measure was found by averaging the LEMMT scores on days 14, 28, 42, and 56 (double-blind treatment period) and subtracting the baseline LEMMT score.|Days -21, -14, -7, 0, 14, 28, 42, 56, 63, 77|||units on a scale||Standard Deviation|Mean
741940|NCT00483652|Primary|Responders Based Upon the Timed 25-Foot Walk [T25FW]|A responder is a patient who showed faster walking speed for at least 3 visits out of a possible 4 during the double-blind period than the maximum value achieved in the 5 non-double-blind no-treatment visits (4 before the double-blind period and one after)|Days -21, -14, -7, 0, 14, 28, 42, 56, 63, 77|Modified Intention-to-Treat [ITT] population||participants|||Number
741941|NCT00489476|Other Pre-specified|Responders, Sustained Freedom From Pain|The percentages of patients with sustained freedom from pain (pain-free at 2 hours after dosing with no rescue medication and no recurrence of headache from 2 to 24 hours)|Baseline through 24 h post-dose|ITT with LOCF Population||Participants|||Count of Participants
741942|NCT00489476|Secondary|Pain-free at 2 Hours|Pain-free (Pain-IHS) at the 2 hour time point|Baseline and 2 h post-dose|ITT with LOCF Population||Participants|||Count of Participants
741943|NCT00489476|Primary|Pain-relief Response (Pain Severity of NONE or MILD) at 2 Hours|"The primary efficacy endpoint was Pain-relief response as defined by the International Headache Society (Pain-IHS) as a pain severity of NONE or MILD.
Intent to treat (ITT) with last observation carried forward (LOCF)"|Baseline and 2 h post-dose|ITT Population with LOCF||participants|||Number
745614|NCT00517192|Secondary|Response up to 48 Weeks Using VL < 50 Copies/mL Using Intent-to-treat||up to 48 weeks||||||
741945|NCT00489489|Secondary|Annualized Relapse Rate [ARR]: Poisson Regression Estimates|"ARR is obtained from the total number of confirmed relapses that occured during the treatment period divided by the sum of the treatment durations.
Each episode of relapse - appearance, or worsening of a clinical symptom that was stable for at least 30 days, that persisted for a minimum of 24 hours in the absence of fever - was to be confirmed by an increase in Expanded Disability Status Scale [EDSS] score or Functional System scores.
To account for the different treatment durations among participants, a Poisson regression model with robust error variance was used (total number of confirmed relapses as response variable; log-transformed treatment duration as offset variable; treatment group, region of enrollment and IFN-β dose level as covariates)."|24 weeks|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.||relapses per year||95% Confidence Interval|Number
741946|NCT00489489|Primary|Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA)|"PCSA values are abnormal values considered medically important by the Sponsor according to predefined criteria based on literature review.
Hepatic parameters thresholds were defined as follows:
Alanine Aminotransferase [ALT] >3, 5, 10 or 20 Upper Normal Limit [ULN];
Aspartate aminotransferase [AST] >3, 5, 10 or 20 ULN;
Alkaline Phosphatase >1.5 ULN;
Total Bilirubin [TB] >1.5 or 2 ULN;
ALT >3 ULN and TB >2 ULN;"|from first study drug intake up to 112 days after last intake or up to the first intake in the extension study LTS6047, whichever occured first (40 weeks max)|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.||participants|||Number
741947|NCT00489489|Secondary|Cerebral MRI Assessment: Volume of Gd-enhancing T1-lesions Per Scan|Total volume of Gd-enhancing T1-lesions per scan is obtained from the sum of the volumes of Gd-enhancing T1-lesions observed during the study divided by the total number of scans performed during the study.|24 weeks|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.||mililiters per scan|||Number
741948|NCT00489489|Secondary|Cerebral MRI Assessment: Number of Gd-enhancing T1-lesions Per Scan (Poisson Regression Estimates)|"Number of Gd-enhancing T1-lesions per scan is obtained from the total number of Gd-enhancing T1-lesions observed during the study divided by the total number of scans performed during the study.
To account for the different number of scans among participants, a Poisson regression model with robust error variance was used (total number of Gd-enhancing T1-lesions as response variable; log-transformed number of scans as offset variable; treatment group, region of enrollment, IFN-β dose level and baseline number of Gd-enhancing T1-lesions as covariates)."|24 weeks|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.||lesions per scan||95% Confidence Interval|Number
741949|NCT00489489|Secondary|Cerebral Magnetic Resonance Imaging [MRI] Assessment: Change From Baseline in Total Lesion Volume (Burden of Disease)|"Total lesion volume is the sum of the total volume of all T2-lesions and the total volume of all T1-hypointense post-gadolinium lesions measured through T2/proton density scan analysis and gadolinium-enhanced T1 scan analysis.
Least-square means were estimated using a Mixed-effect model with repeated measures [MMRM] on cubic root transformed volume data (treatment group, region of enrollment, IFN-β dose level, visit, treatment-by-visit interaction, baseline value (cubic root transformed), and baseline-by-visit interaction as factors)."|baseline (before randomization) and 24 weeks|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.||mililiters||Standard Error|Least Squares Mean
741950|NCT00489489|Primary|Overview of AE With Potential Risk of Occurrence|"AE with potential risk of occurrence were defined as follows:
Hepatic disorders;
Immune effects, mainly effects on bone marrow and infection;
Pancreatic disorders;
Malignancy;
Skin disorders, mainly Hair loss and Hair thinning;
Pulmonary disorders;
Hypertension;
Peripheral neuropathy;
Psychiatric disorders;
Hypersensitivity."|from first study drug intake up to 112 days after last intake or up to the first intake in the extension study LTS6047, whichever occured first (40 weeks max)|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.||participants|||Number
741951|NCT00489489|Primary|Overview of Adverse Events [AE]|AE are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.|from first study drug intake up to 112 days after last intake or up to the first intake in the extension study LTS6047, whichever occured first (40 weeks max)|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.||participants|||Number
741952|NCT00489541|Secondary|Number of Participants With Target Lesion Failure (TLF) at 12 Months Post-index Procedure. TLF is Defined as Any Ischemia-driven Revascularization of the Target Lesion, Myocardial Infarction (Q-wave and Non-Q-wave), or Death Related to the Target Vessel.|The number of participants who experience a TLF through 365 days post-procedure out of the patients who have either had a TLF within 365 days post-procedure or who were TLF-free with last follow-up at least 335 days post-procedure.|12 months post-index procedure|Intent-to-Treat. All enrolled patients are included in the analysis.||participants|||Number
741953|NCT00489541|Primary|In-stent Late Loss Measured by Quantitative Coronary Angiography (QCA)|Post-procedure minimum lumen diameter (mm) minus follow-up minimum lumen diameter as determined by quantitative angiography. Minimum lumen diameter is measured within the stent at each time point.|9 months post-index procedure|The primary analysis population for the superiority testing of the primary endpoint, 9-month in-stent late loss, is the intent-to-treat (ITT) population, i.e. all patients who had a study device implanted at the target lesion and completed their angiographic follow-up.||millimeter||Standard Deviation|Mean
741954|NCT00489554|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Up to Month 5|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
741955|NCT00489554|Secondary|Number of Subjects Reporting Any Unsolicited AEs|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within 31 days after any vaccine dose|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
741956|NCT00489554|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs|Any fever was defined as axillary temperature ≥ 37.5 degree centigrade (°C), grade 3 fever was axillary temperature > 39.5°C. Grade 3 drowsiness, irritability, and loss of appetite was general symptom which prevented normal everyday activities. Grade 3 diarrhea was ≥ 6 looser than normal stools/day and Grade 3 vomiting was ≥ 3 episodes of vomiting/day. Related was solicited general symptom considered by the investigator to have a causal relationship to study vaccination.|Within 4 days following any vaccine dose|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
741957|NCT00489554|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)|Grade 3 redness and swelling was > 30 millimeter (mm) and grade 3 pain was subjects crying when limb was moved/spontaneously painful. Any was occurrence of any local symptom regardless of grade and whatever the number of injections.|Within 4 days following any vaccine dose|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
741958|NCT00489554|Secondary|Number of Subjects Seropositive for Anti-Protein D Antibodies|Seropositivity was defined as antibody concentration greater than or equal to 100 Enzyme-Linked Immuno Sorbent Assay (ELISA) units per milliliter.|One month after the administration of the 3rd vaccine dose i.e. Month 5|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available.||subjects|||Number
741959|NCT00489554|Secondary|Number of Subjects Seropositive for Opsonic Titer Against Cross-reactive Pneumococcal Serotypes|Seropositivity was defined as anti-pneumococcal antibody opsonic titer greater than or equal to 8. The vaccine pneumococcal cross-reactive serotypes assessed include 6A and 19A.|One month after the administration of the 3rd vaccine dose i.e. Month 5|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available.||subjects|||Number
741960|NCT00489554|Secondary|Number of Subjects Seropositive Against Cross-reactive Pneumococcal Serotypes|Seropositivity was defined as anti-pneumococcal antibody concentration greater than or equal to 0.05 microgram per milliliter. The cross-reactive pneumococcal serotypes assessed include 6A and 19A.|One month after the administration of the 3rd vaccine dose i.e. Month 5|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available.||subjects|||Number
741961|NCT00489554|Secondary|Number of Subjects Seropositive for Opsonic Titer Against Vaccine Pneumococcal Serotypes|Seropositivity was defined as an opsonic titer greater than or equal to 8. The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.|One month after the administration of the 3rd vaccine dose i.e. Month 5|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available.||subjects|||Number
741962|NCT00489554|Secondary|Number of Subjects Seropositive Against Vaccine Pneumococcal Serotypes|Seropositivity was defined as anti-pneumococcal antibody concentration greater than or equal to 0.05 microgram per milliliter. The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.|One month after the administration of the 3rd vaccine dose i.e. Month 5|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available.||subjects|||Number
741963|NCT00489554|Secondary|Opsonophagocytic Titer Against Pneumococcal Cross-reactive Serotypes|The results were presented as the geometric mean dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cross-reactive pneumococcal serotypes assessed include 6A and 19A.|One month after the administration of the 3rd vaccine dose i.e. Month 5|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available.||titer||95% Confidence Interval|Geometric Mean
741964|NCT00489554|Secondary|Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes|Antibody concentrations were expressed as Geometric Mean Concentrations against pneumococcal cross-reactive serotypes 6A and 19A.|One month after the administration of the 3rd vaccine dose i.e. Month 5|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available.||microgram per milliliter||95% Confidence Interval|Geometric Mean
741965|NCT00489554|Secondary|Number of Subjects With Anti-pneumococcal Vaccine Serotypes Antibody Concentrations Greater Than or Equal to 0.2 Microgram Per Milliliter|The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.|One month after the administration of the 3rd vaccine dose i.e. Month 5|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available.||subjects|||Number
741966|NCT00489554|Secondary|Opsonophagocytic Titer Against Pneumococcal Vaccine Serotypes|The results were presented as the geometric mean dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.|One month after the administration of the 3rd vaccine dose i.e. Month 5|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available.||titer||95% Confidence Interval|Geometric Mean
741967|NCT00489554|Primary|Antibody Concentrations Against Protein D|Concentrations were given as geometric mean concentration (GMC) expressed as enzyme-linked immuno-sorbent assay (ELISA) units per milliliter.|One month after the administration of the 3rd vaccine dose i.e. Month 5|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available.||ELISA units per milliliter||95% Confidence Interval|Geometric Mean
741968|NCT00489554|Primary|Antibody Concentrations Against Pneumococcal Vaccine Serotypes|Concentrations were expressed as geometric mean concentration (GMC). The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.|One month after the administration of the 3rd vaccine dose i.e. Month 5|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available.||microgram per milliliter||95% Confidence Interval|Geometric Mean
744261|NCT00508027|Other Pre-specified|Change in Plasma Hs-CRP Levels|Change in plasma high sensitivity C-reactive protein levels in subjects treated with simvastatin|Baseline, 21 days|||mg/L||Standard Deviation|Mean
741969|NCT00489736|Other Pre-specified|Occurrence of the MSE Excluding Gastrointestinal Specific Treatment Emergent Events Defined as Diarrhoea, Nausea, Vomiting|"The considered event is the occurrence of the MSE excluding gastrointestinal specific treatment emergent events defined as diarrhoea, nausea, vomiting. The analysis is performed on the time from first study drug intake to this event. The Measured Values table below presents the numbers of patients with the event at the end of the study period."|minimum study duration is 6 months (+10 days); maximum is 15 months|All randomized and treated patients (receiving at least one dose of study drug) were included in the safety analysis according to the treatment received.||participants|||Number
741970|NCT00489736|Secondary|Occurrence of the Main Safety Endpoint (MSE) Defined as Thyroid, Hepatic, Pulmonary, Neurological, Skin, Eye, or Gastrointestinal Specific Treatment Emergent Events or Premature Study Drug Discontinuation Following Any Adverse Event|"The considered event is the occurrence of the MSE defined as thyroid, hepatic, pulmonary, neurological, skin, eye, or gastrointestinal specific treatment emergent events or premature study drug discontinuation following any adverse event (AE), whichever comes first. The analysis is performed on the time from first study drug intake to this event. The Measured Values table below presents the numbers of patients with the event at the end of the study period."|minimum study duration is 6 months (+10 days); maximum is 15 months|All randomized and treated patients (receiving at least one dose of study drug) were included in the safety analysis according to the treatment received.||participants|||Number
741971|NCT00489736|Primary|Treatment Failure|"The primary event is the treatment failure defined as the first recurrence of atrial fibrillation or premature study drug discontinuation for intolerance or lack of efficacy according to the investigator judgement. The primary efficacy analysis is performed on the time from first study drug intake to this primary event. The Measured Values table below presents the numbers of patients with the event at the end of the study period."|minimum study duration is 6 months (+10 days); maximum is 15 months|All randomized and treated patients (receiving at least one dose of study drug) were included in the efficacy analysis according to the treatment received.||participants|||Number
741972|NCT00489853|Secondary|SGRQ-C (St. George's Respiratory Questionnaire for COPD Patients) Total Score|Score from a questionnaire, with scores ranging form 0 (perfect health) to 100 (worst possible state). Includes all patients with data.|Single measurement taken at the end of each 1-week treatment period|||Scores on a scale||Standard Deviation|Mean
741973|NCT00489853|Secondary|Specific Airway Resistance (sRaw) (Body Plethysmography) Performed Before 6 Hours Post-dose EET|Treatment means from individual participant data.|Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period|||Kilopascals||Standard Deviation|Mean
741974|NCT00489853|Secondary|Total Lung Capacity (TLC) (Body Plethysmography) Performed Before 6 Hours Post-dose Exercise Endurance Time (EET)|Treatment means from individual participant data.|Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period|||Liters||Standard Deviation|Mean
741975|NCT00489853|Secondary|Residual Volume (RV) (Body Plethysmography) Performed Before 6 Hour Post-dose Exercise Endurance Time (EET)|Treatment means from individual participant data.|Single measurement obtained before exercise endurance test performed 6 hous post-dose at the end of each 1-week treatment period|||Liters||Standard Deviation|Mean
741976|NCT00489853|Secondary|Forced Respiratory Capacity (FRC) (Body Plethysmography) Performed Before 6 Hours Post-dose Exercise Endurance Time (EET)|Treatment means from individual participant data.|Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period|||Liters||Standard Deviation|Mean
741977|NCT00489853|Secondary|Inspiratory Capacity (IC) (Body Plethysmography) Performed Before 6 Hour Post-dose Exercise Endurance Time (EET)|Treatment means from individual participant data.|Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period|||Liters||Standard Deviation|Mean
741978|NCT00489853|Secondary|Vital Capacity (VC) (Body Plethysmography) Performed Before 6 Hour Exercise Endurance Time (EET)|Treatment means from individual participant data.|Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period|||Liters||Standard Deviation|Mean
741979|NCT00489853|Secondary|Specific Airway Resistance (sRaw) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET)|Treatment means from individual participant data.|Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period|||kilopascal||Standard Deviation|Mean
741980|NCT00489853|Secondary|Total Lung Capacity (TLC) (Body Plethysmography) Performed Before 1 Hour Exercise Endurance Time (EET)|Treatment means from individual participant data.|Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period|||Liter||Standard Deviation|Mean
741981|NCT00489853|Secondary|Residual Volume (RV) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET)|Treatment means from individual participant data.|Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period|||Liters||Standard Deviation|Mean
741982|NCT00489853|Secondary|Forced Respiratory Capacity (FRC) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET)|Treatment means from individual participant data.|Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period|||Liters||Standard Deviation|Median
741983|NCT00489853|Secondary|Inspiratory Capacity (IC) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET)|Treatment means from individual participant data.|Single measurement obtained before exercise endurance test performed 1hour post-dose at the end of each 1-week treatment period|||Liters||Standard Deviation|Mean
741984|NCT00489853|Secondary|Vital Capacity (VC) (Body Plethysmography) Performed Before 1 Hour Exercise Endurance Time (EET)|Treatment means from individual participant data.|Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period|||Liters||Standard Deviation|Mean
741985|NCT00489853|Secondary|Inspiratory Capacity (IC) Before Exercise Endurance Time (EET) Performed 6 Hours Post-dose|Treatment means from individual participant data.|Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period|||Liters||Standard Deviation|Mean
744424|NCT00509392|Primary|Tenderness|Tenderness 0-10 scale (10 most severe)|2 Weeks|Data available at 2-week follow-up visit||units on a scale|limbs|Standard Deviation|Mean
741988|NCT00489853|Secondary|Borg CR10 Score Before Exercise Endurance Time (EET) Performed 6 Hour Post-dose|The level of breathing discomfort experienced by patients, on a scale of 0 (no breathing discomfort at all) to >10 (absolute maximum breathing discomfort).|Single measurement performed at rest prior to exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period|||Scores on a scale||Standard Deviation|Mean
741989|NCT00489853|Secondary|Borg CR10 Score After Exercise Endurance Time (EET) Performed 1 Hour Post-dose|The level of breathing discomfort experienced by patients, on a scale of 0 (no breathing discomfort at all) to >10 (absolute maximum breathing discomfort).|Single measurement performed after exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period|||Scores on a scale||Standard Deviation|Mean
741990|NCT00489853|Secondary|Borg CR10 Score Before Exercise Endurance Time (EET) Performed 1 Hour Post-dose|The Borg CR10 Scale consists of 10-point score that the patients pointed to so as to indicate their level of dyspnea before and during exercise testing (where 0 indicates no breathlessness at all and 10 indicates maximum breathlessness. Patients are allowed to assign an even higher number depending on their perceived level of breathlessness).|Single measurement performed at rest prior to exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period|||Scores on a scale||Standard Deviation|Mean
741991|NCT00489853|Secondary|Number of Inhalations of Reliever Medication|The change in average daily use for the run-in or wash-out period to the average daily use of the subsequent treatment period.|Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period|||Number of inhalations during 24 hours||Standard Deviation|Mean
741992|NCT00489853|Secondary|Cough Score|The change in average value for the run-in or wash-out period to the average value of the subsequent treatment period, with an ordinal scale of 0 (unaware of coughing) to 4 (never free of need to cough).|Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period|||Scores on a scale||Standard Deviation|Mean
741993|NCT00489853|Secondary|Chest Tightness Score|The change in average value for the run-in or wash-out period to the average value of the subsequent treatment period, with an ordinal scale of 0 (unaware of any discomfort) to 4 (almost constant discomfort).|Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period|||Score on a scale||Standard Deviation|Mean
741994|NCT00489853|Secondary|Breathlessness Score|The change in average value for the run-in or wash-out period to the average value of the subsequent treatment period, with an ordinal scale of 0 (unaware of any difficulty in breathing) to 4 (almost constant difficulties in breathing). All patients with data from both periods are included.|Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period|||Score on Scale||Standard Deviation|Mean
741995|NCT00489853|Secondary|Sleep Score|The change in average value for the run-in or wash-out period to the average value of the subsequent treatment period, with an ordinal scale of 0 (symptoms did not cause a sleep problem) to 4 (did not sleep at all due to symptoms).|Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period|||Score on Scale||Standard Deviation|Mean
741996|NCT00489853|Secondary|Peak Expiratory Flow (PEF) Before Morning Dose|The change in average value for the run-in or wash-out period to the average value of the subsequent treatment period.|Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period|||Liters/minute||Standard Deviation|Mean
741997|NCT00489853|Secondary|Vital Capacity (VC) Pre-dose (Change From Pre-treatment to Treatment)|The mean of the changes for each patient between the pre-dose value at the start of treatment and the pre-dose value after one week of treatment.|Pre-dose at the start of treatment and pre-dose after one week of treatment|||Liters||Standard Deviation|Mean
741998|NCT00489853|Secondary|Forced Vital Capacity (FVC) Pre-dose|The mean of the changes for each patient between the pre-dose value at the start of treatment and the pre-dose value after one week of treatment.|Pre-dose at the start of treatment and pre-dose after one week of treatment|||Liters||Standard Deviation|Mean
741999|NCT00489853|Secondary|Forced Expiratory Flow (FEV1) Pre-dose|The mean of the changes for each patient between the pre-dose value at the start of treatment and the pre-dose value after one week of treatment.|Pre-dose at the start of treatment and pre-dose after one week of treatment|||Liters||Standard Deviation|Mean
742000|NCT00489853|Secondary|Exercise Endurance Time (EET) at 75% of Peak Work Capacity With Cycle Ergometry 6 Hour Post-dose|Treatment means from individual patient data. Patients with only one EET value where excluded since this model, with patient and period as fixed factors, required data from at least two periods.|Single measurement taken 6 hours post-dose at the end of each 1-week treatment period|||Seconds||Standard Deviation|Mean
742001|NCT00489853|Primary|Exercise Endurance Time (EET) at 75% of Peak Work Capacity With Cycle Ergometry 1 Hour Post-dose|Treatment means from individual patient data. Patients with only one EET value where excluded since this model, with patient and period as fixed factors, required data from at least two periods.|Single measurement taken1 hour post-dose at the end of each 1-week treatment period|||Seconds||Standard Deviation|Mean
742002|NCT00489866|Secondary|Beck Depression Inventory, Second Edition (BDI-II)|The Beck Depression Inventory-II (BDI) is a very sensitive and widely used instrument used to detect depressive symptoms. It consists of 21 items that assess the intensity of depression in both clinical and non-clinical subjects. Each item is a list of four statements arranged in increasing severity regarding a particular symptom of depression. Scores range from 0 to 63 (higher scores suggest higher levels of depression). Change scores were calculated from Week 2 and Week 6 scores (Week 2 minus Week 6).|Week 2 and Week 6|Analysis was Intention to Treat. Last Observation Carried Forward was the imputation technique utilized.||Units on a Scale||Standard Deviation|Mean
742003|NCT00489866|Secondary|Connor-Davidson Resilience Scale (CD-RISC)|This scale measures resilience. Range of scores (0-100). A score of 0 is suggestive of no resilience, a score of 100 is suggestive of high level of resilience. Change scores calculated at Week 2 and Week 6 (Week 2 minus Week 6).|Week 2 and Week 6|Analysis was Intention to Treat. Last Observation Carried Forward was the imputation technique utilized.||Units on a scale||Standard Deviation|Mean
742068|NCT00490269|Primary|Number of Participants That Experience Cardiovascular Effects of Smoked Marijuana or Has Any Other Combination Side Effects.|Does dronabinol (when given during smoking of a marijuana cigarette) show changes in the number of participants that experience cardiovascular effects of smoked marijuana or has any other combination side effects.|Day 9 and 10|||participants|||Number
742004|NCT00489866|Primary|Positive and Negative Symptoms Scale (PANSS)|The PANSS is a widely used measure with several subdomains, including positive symptoms, negative symptoms, and general psychopathology of schizophrenia. Lower scores are indicative of fewer symptoms; higher scores are indicative of more symptoms. Total PANSS scores range from 0-20.Mean change scores from Week 2 and Week 6 (Week 2 minus Week 6)|Week 2 and Week 6|Analysis was Intention to Treat. Last Observation Carried Forward was the imputation technique utilized.||Units on a Scale||Standard Deviation|Mean
742005|NCT00489866|Primary|Brief Assessment of Cognition in Affective Disorders (BAC-A)|The BACS includes brief assessments of executive functions, verbal fluency, attention, verbal memory, working memory and motor speed. Z-scores are calculated from composite scores. Higher z-scores are indicative of better cognitive performance, lower z-scores are indicative of lower cognitive performance. Range of z-scores anticipated to be between -3 and 3. Mean change scores from week 2 and week 6 (Week 2 minus Week 6).|Week 2 and Week 6|||Units on a Scale||Standard Deviation|Mean
742006|NCT00489866|Primary|Clinician Administered PTSD Scale (CAPS)|"Mean change scores (Week 2 minus Week 6) in posttraumatic stress disorder symptoms. Scores may range from 0 (no symptoms) to 136 (severe symptoms; score of 136 is based on the first 17 CAPS items administered).
A reduced CAPS score indicates a reduction in (improvement) PTSD symptoms, while an increase in CAPS score indicates an increase (worsening) in PTSD symptoms."|Week 2 and Week 6|Analysis was intention to treat.||Units on a scale||Standard Deviation|Mean
742007|NCT00489970|Secondary|Anti-PRN Antibody Concentration||9 years following vaccination||06/2016||||
742008|NCT00489970|Secondary|Anti-FHA Antibody Concentration||9 years following vaccination||06/2016||||
742009|NCT00489970|Secondary|Anti-PT Antibody Concentration||9 years following vaccination||06/2016||||
742010|NCT00489970|Secondary|Anti-T Antibody Concentration||9 years following vaccination||06/2016||||
742011|NCT00489970|Secondary|Anti-D Antibody Concentration||9 years following vaccination||06/2016||||
742012|NCT00489970|Secondary|Number of Subjects With Anti-pertactin (PRN) Antibody Concentrations Equal to or Above Protocol Specified Cut-off||9 years following vaccination||06/2016||||
742013|NCT00489970|Secondary|Number of Subjects With Anti-filamentous Hemagglutinin (FHA) Antibody Concentrations Equal to or Above Protocol Specified Cut-off||9 years following vaccination||06/2016||||
742014|NCT00489970|Secondary|Number of Subjects With Anti-pertussis Toxoid (PT) Antibody Concentrations Equal to or Above Protocol Specified Cut-off||9 years following vaccination||06/2016||||
742015|NCT00489970|Secondary|Anti-PRN Antibody Concentration|Anti-PRN antibody concentration is expressed as GMC in EL.U/mL.|1, 3 and 5 years following vaccination|Analysis was performed on the According-to-Protocol (ATP) Year 1, 3 or 5 Cohort, which included all subjects who were in the ATP cohort for analysis of immunogenicity in the primary study (NCT00346073) and for whom serological results for at least one antigen were available for the specified timepoint||EL.U/mL||95% Confidence Interval|Geometric Mean
742016|NCT00489970|Secondary|Anti-FHA Antibody Concentration|Anti-FHA antibody concentration is expressed as GMC in EL.U/mL.|1, 3 and 5 years following vaccination|Analysis was performed on the According-to-Protocol (ATP) Year 1, 3 or 5 Cohort, which included all subjects who were in the ATP cohort for analysis of immunogenicity in the primary study (NCT00346073) and for whom serological results for at least one antigen were available for the specified timepoint||EL.U/mL||95% Confidence Interval|Geometric Mean
742017|NCT00489970|Secondary|Anti-PT Antibody Concentration|Anti-PT antibody concentration is expressed as GMC in EL.U/mL.|1, 3 and 5 years following vaccination|Analysis was performed on the According-to-Protocol (ATP) Year 1, 3 or 5 Cohort, which included all subjects who were in the ATP cohort for analysis of immunogenicity in the primary study (NCT00346073) and for whom serological results for at least one antigen were available for the specified timepoint||EL.U/mL||95% Confidence Interval|Geometric Mean
742018|NCT00489970|Secondary|Anti-T Antibody Concentration|Anti-T antibody concentration is expressed as GMC in IU/mL.|1, 3 and 5 years following vaccination|Analysis was performed on the According-to-Protocol (ATP) Year 1, 3 or 5 Cohort, which included all subjects who were in the ATP cohort for analysis of immunogenicity in the primary study (NCT00346073) and for whom serological results for at least one antigen were available for the specified timepoint||IU/mL||95% Confidence Interval|Geometric Mean
742019|NCT00489970|Secondary|Anti-D Antibody Concentration|Anti-D antibody concentration is expressed as geometric mean concentration (GMC) in IU/mL.|1, 3 and 5 years following vaccination|Analysis was performed on the According-to-Protocol (ATP) Year 1, 3 or 5 Cohort, which included all subjects who were in the ATP cohort for analysis of immunogenicity in the primary study (NCT00346073) and for whom serological results for at least one antigen were available for the specified timepoint||IU/mL||95% Confidence Interval|Geometric Mean
742020|NCT00489970|Secondary|Number of Subjects With Anti-pertactin (PRN) Antibody Concentrations Equal to or Above Protocol Specified Cut-off|The cut-off for anti-PRN concentrations was defined as equal to or greater than 5 EL.U/mL.|1, 3 and 5 years following vaccination|Analysis was performed on the According-to-Protocol (ATP) Year 1, 3 or 5 Cohort, which included all subjects who were in the ATP cohort for analysis of immunogenicity in the primary study (NCT00346073) and for whom serological results for at least one antigen were available for the specified timepoint||subjects|||Number
742021|NCT00489970|Secondary|Number of Subjects With Anti-filamentous Hemagglutinin (FHA) Antibody Concentrations Equal to or Above Protocol Specified Cut-off|The cut-off for anti-FHA concentrations was defined as equal to or greater than 5 EL.U/mL.|1, 3 and 5 years following vaccination|Analysis was performed on the According-to-Protocol (ATP) Year 1, 3 or 5 Cohort, which included all subjects who were in the ATP cohort for analysis of immunogenicity in the primary study (NCT00346073) and for whom serological results for at least one antigen were available for the specified timepoint.||subjects|||Number
742022|NCT00489970|Secondary|Number of Subjects With Anti-pertussis Toxoid (PT) Antibody Concentrations Equal to or Above Protocol Specified Cut-off|The cut-off for anti-PT concentrations was defined as equal to or greater than 5 ELISA units per mililiter (EL.U/mL).|1, 3 and 5 years following vaccination|Analysis was performed on the According-to-Protocol (ATP) Year 1, 3 or 5 Cohort, which included all subjects who were in the ATP cohort for analysis of immunogenicity in the primary study (NCT00346073) and for whom serological results for at least one antigen were available for the specified timepoint||subjects|||Number
742069|NCT00490477|Secondary|The Reduction of the Number of Apoptotic Cells, Stimulated With Plasma Derives From Septic Patients With Gram Negative Infection, Treated With PMX-B Hemoperfusion, on Immortalized Tubular and Glomerular Cell Cultures.||72 hours after randomization||04/2007||||
742023|NCT00489970|Primary|Number of Subjects With Anti-diphtheria (Anti-D) Antibody Concentrations Equal to or Above Protocol Specified Cut-off|Anti-D cut-off was defined as greater than or equal to 0.1 international units per mililiter (IU/mL) determined with Enzyme-linked Immunosorbent Assay (ELISA) or VERO.|1, 3 and 5 years following vaccination|Analysis was performed on the According-to-Protocol (ATP) Year 1, 3 or 5 Cohort, which included all subjects who were in the ATP cohort for analysis of immunogenicity in the primary study (NCT00346073) and for whom serological results for at least one antigen were available for the specified timepoint.||subjects|||Number
742024|NCT00489970|Primary|Number of Subjects With Anti-tetanus (Anti-T) Antibody Concentrations Equal to or Above Protocol Specified Cut-off||9 years following vaccination||06/2016||||
742025|NCT00489970|Primary|Number of Subjects With Anti-tetanus (Anti-T) Antibody Concentrations Equal to or Above Protocol Specified Cut-off|Anti-T cut-off was defined as greater than or equal to 0.1 IU/mL (ELISA).|1, 3 and 5 years following vaccination|Analysis was performed on the According-to-Protocol (ATP) Year 1, 3 or 5 Cohort, which included all subjects who were in the ATP cohort for analysis of immunogenicity in the primary study (NCT00346073) and for whom serological results for at least one antigen were available for the specified timepoint||subjects|||Number
742026|NCT00489970|Primary|Number of Subjects With Anti-diphtheria (Anti-D) Antibody Concentrations Equal to or Above Protocol Specified Cut-off||9 years following vaccination||06/2016||||
742027|NCT00490009|Secondary|Overall Survival (OS) Rate|Overall survival reported as the percentage of participants (less lost-to-follow-up) surviving at 6 years.|6 years|1 of the 9 study participants was lost-to-follow-up, and did not contribute data to this outcome.||percentage of participants|||Number
742028|NCT00490009|Secondary|Time to Progression (TTP)|Time of disease progression reported as the number of subjects experiencing disease progression at the time point of progression.|1.5 months; 3 months; 6 months; or Not Progressed|1 of the 9 study participants was lost-to-follow-up, and did not contribute data to this outcome.||participants|||Number
742029|NCT00490009|Primary|Clinical Response Rate|Clinical response rate for all participants, reported as the sum of the numbers of patients achieving complete response (CR, complete disappearance of all lesions); functional CR (fCR, minimal residual disease but clear of disease by positron emission tomography (PET)-scan); or partial response (PR, ≥ decrease in size of lesions and negative for active disease by PET-scan). Progressive disease (PD, advancing cancer) or stable disease (not CR, fCR, or PD) not included as Clinical Response.|6 years|||participants|||Number
742030|NCT00490022|Secondary|Prostate Epithelial Cell Proliferation|Prostate epithelial cell proliferation in the prostate biopsy tissue was measured using Ki-67 immunohistochemical staining of prostate epithelium as a marker of cell proliferation (values are number of Ki-67 positive stained cells per 100 prostate epithelial cells). The placebo and treatment groups were compared.|28-days|||#pos.Ki-67cells per100 prst. epth cells||Standard Deviation|Mean
742031|NCT00490022|Primary|Prostate Tissue DHT and Testosterone Levels After 28 Days of Treatment With Dihydrotestosterone [DHT] Gel Versus Placebo Gel.|After 4 weeks of either daily dihydrotestosterone transdermal gel or placebo gel, subjects underwent a prostate biopsy. Intraprostatic hormone concentrations, specifically DHT and Testosterone, were measured. Unit of measure is ng/g.|28-days|||ng/g||Standard Deviation|Mean
742032|NCT00490035|Secondary|Change From Baseline to the 12-week Treatment Period in Health Status of Life Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.|From Baseline to 12-week Treatment Period|Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit or Early Discontinuation Visit.||units on a scale||Standard Deviation|Mean
742033|NCT00490035|Secondary|Change From Baseline to the 12-week Treatment Period in Overall Quality of Life Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.|From Baseline to 12-week Treatment Period|Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit or Early Discontinuation Visit.||units on a scale||Standard Deviation|Mean
742034|NCT00490035|Secondary|Change From Baseline to the 12-week Treatment Period in Medication Effects Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.|From Baseline to 12-week Treatment Period|Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit or Early Discontinuation Visit.||units on a scale||Standard Deviation|Mean
742070|NCT00490477|Primary|Number of Participants Not Requiring Renal Replacement Therapy (RRT)||28 days from the admission|||participants|||Number
742071|NCT00490490|Secondary|Time-to-Progression (TTP)||2 years|One subject has not progressed (assessment not possible), and one subject has been lost to follow-up.||Participants|||Count of Participants
743541|NCT00486278|Secondary|Biochemistry: Creatinine||screening visit, pre-dose and 12 hours after dosing|Safety analysis set includes all subjects who received at least one dose of the investigational product.||micromol/L||Standard Deviation|Mean
742035|NCT00490035|Secondary|Change From Baseline to the 12-week Treatment Period in Cognitive Functioning Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.|From Baseline to 12-week Treatment Period|Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit or Early Discontinuation Visit.||units on a scale||Standard Deviation|Mean
742036|NCT00490035|Secondary|Change From Baseline to the 12-week Treatment Period in Emotional Well-Being Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.|From Baseline to 12-week Treatment Period|Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit or Early Discontinuation Visit.||units on a scale||Standard Deviation|Mean
742037|NCT00490035|Secondary|Change From Baseline to the 12-week Treatment Period in Energy/Fatigue Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.|From Baseline to 12-week Treatment Period|Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit or Early Discontinuation Visit.||units on a scale||Standard Deviation|Mean
742038|NCT00490035|Secondary|Investigator's Global Evaluation Scale (I-GES) Evaluated at Last Visit or Early Discontinuation Visit|The Investigator's Global Evaluation Scale (I-GES) is a global assessment of the disease evolution which was performed using a seven-point scale (1 = Marked worsening to 7 = Marked improvement), with the start of the study medication as reference time point. The Investigator was to complete it by answering the following question: “Assess the Overall change in the severity of patient’s illness, compared to start of study medication.”|Last Visit or Early Discontinuation Visit in the 12-week Treatment Period|Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit or Early Discontinuation Visit.||units on a scale||Standard Deviation|Mean
742039|NCT00490035|Secondary|Patient's Global Evaluation Scale (P-GES) Evaluated at Last Visit or Early Discontinuation Visit|The Patient's Global Evaluation Scale (P-GES) is a global assessment of the disease evolution which was performed using a seven-point scale (1 = Marked worsening to 7 = Marked improvement) with the start of the study medication as the reference time point. The subject not mentally impaired had to complete it by answering the following question: “Overall, has there been a change in your seizures since the start of the study medication?”|Last Visit or Early Discontinuation Visit in the 12-week Treatment Period|Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit or Early Discontinuation Visit.||units on a scale||Standard Deviation|Mean
742040|NCT00490035|Secondary|Change From Baseline to the 12-week Treatment Period in Hospital Depression Score|The Hospital Anxiety and Depression Scale (HADS) was used to evaluate anxiety and depression simultaneously. The HADS was developed as a self-administered scale that has been designed to assess the presence and severity of both anxiety and depression. It consists of 14 items that are scored on a 4-point severity scale ranging from 0 to 3. A score per dimension was calculated with each score ranging from 0 to 21 and higher scores indicating higher depression / anxiety. Negative values in Change from Baseline indicate a decrease of HADS from Baseline to Treatment Period.|From Baseline to 12-week Treatment Period|Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit / Early Discontinuation Visit.||units on a scale||Standard Deviation|Mean
742041|NCT00490035|Secondary|Change From Baseline to the 12-week Treatment Period in Hospital Anxiety Score|The Hospital Anxiety and Depression Scale (HADS) was used to evaluate anxiety and depression simultaneously. The HADS was developed as a self-administered scale that has been designed to assess the presence and severity of both anxiety and depression. It consists of 14 items that are scored on a 4-point severity scale ranging from 0 to 3. A score per dimension was calculated with each score ranging from 0 to 21 and higher scores indicating higher depression / anxiety. Negative values in Change from Baseline indicate a decrease of HADS from Baseline to Treatment Period.|From Baseline to 12-week Treatment Period|Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit / Early Discontinuation.||units on a scale||Standard Deviation|Mean
742042|NCT00490035|Secondary|Change From Baseline to the 12-week Treatment Period in Daily Activities/Social Functioning Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.|From Baseline to 12-week Treatment Period|Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit / Early Discontinuation.||units on a scale||Standard Deviation|Mean
742043|NCT00490035|Secondary|Change From Baseline to the 12-week Treatment Period in Seizure Worry Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.|From Baseline to 12-week Treatment Period|Subjects in the Intention-To-Treat (ITT) population with measurements at Baseline and Last Visit / Early Discontinuation.||units on a scale||Standard Deviation|Mean
742044|NCT00490035|Secondary|Change From Baseline to the 12-week Treatment Period in Total Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.|From Baseline to 12-week Treatment Period|Subjects in the Intention-To-Treat (ITT) population with measurements at Baseline and Last Visit / Early Discontinuation.||units on a scale||Standard Deviation|Mean
742045|NCT00490035|Secondary|Reduction of Type IC/Type I Seizure Frequency Ratio From Baseline to the 12- Week Treatment Period.|The type IC/Type I seizure frequency ratio is represented by the percentage of subjects having a reduction in the ratio of Type IC seizure frequency over Type IA, IB, and IC seizure frequency from Baseline to Treatment Period.|From Baseline to 12-week Treatment Period|"The Intention-to-treat (ITT) population was defined as all randomized subjects who received at least 1 dose of study medication.
Type IC Population consists of those subjects with at least one Type IC seizure during the Baseline period."||percentage of participants|||Number
742046|NCT00490035|Secondary|Time to Tenth Type I Seizure During the 12-week Treatment Period|The time to tenth Type I Seizure during the 12-week Treatment Period was measured in days.|From Baseline to 12-week Treatment Period|The Intention-to-treat (ITT) population was defined as all randomized subjects who received at least 1 dose of study medication.||Days||95% Confidence Interval|Median
742047|NCT00490035|Secondary|Time to Fifth Type I Seizure During the 12-week Treatment Period|The time to Fifth Type I Seizure during the 12-week Treatment Period was measured in days.|From Baseline to 12-week Treatment Period|The Intention-to-treat (ITT) population was defined as all randomized subjects who received at least 1 dose of study medication.||Days||95% Confidence Interval|Median
742048|NCT00490035|Secondary|Time to First Type I Seizure During the 12-week Treatment Period|The time to first Type I Seizure during the 12-week Treatment Period was measured in days.|From Baseline to 12-week Treatment Period|The Intention-to-treat (ITT) population was defined as all randomized subjects who received at least 1 dose of study medication.||Days||95% Confidence Interval|Median
742049|NCT00490035|Secondary|Seizure Freedom Rate (All Seizure Types) Over the 12-week Treatment Period|Subjects were considered seizure free if their seizure counts for every day over the entire Treatment Period was zero and if they completed the Treatment Period.|From Baseline to 12-week Treatment Period|The Intention-to-treat (ITT) population was defined as all randomized subjects who received at least 1 dose of study medication.||Percentage of Participants|||Number
742050|NCT00490035|Secondary|Categorized Percentage Change From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 12-week Treatment Period|"The categories are:
<= 25 %
- 25 % to < 25 %
25 % to < 50 %
50 % to < 75 %
75 % to < 100 %
100 %"|From Baseline to 12-week Treatment Period|The Intention-to-treat (ITT) population was defined as all randomized subjects who received at least 1 dose of study medication.||Percentage of Participants|||Number
742051|NCT00490035|Secondary|Percent Change From Baseline to the 12-week Treatment Period in Partial Onset Seizure (Type I) Frequency Per Week|The percent change from Baseline was computed as: Weekly Seizure Frequency (Treatment) - Weekly Seizure Frequency (Baseline) / Weekly Seizure Frequency (Baseline) * 100. Negative values indicate a reduction from Baseline with higher negative values showing higher reduction.|From Baseline to 12-week Treatment Period|The Intention-to-treat (ITT) population was defined as all randomized subjects who received at least 1 dose of study medication.||Percent change in seizures per week||Inter-Quartile Range|Median
742052|NCT00490035|Secondary|All Seizure Frequency (Type I+II+III) Per Week Over the 12-week Treatment Period|There are three types of Epilepsy: Partial Epilepsies (Type I), Generalized Epilepsies (Type II) and uncertain classification of Epilepsies (Type III).|From Baseline to 12-week Treatment Period|The Intention-to-treat (ITT) population was defined as all randomized subjects who received at least 1 dose of study medication.||Times per week||Inter-Quartile Range|Median
742053|NCT00490035|Secondary|Responder Rate for Partial Onset Seizures (Type I) Frequency Per Week Over the 12-week Treatment Period|"Responders are those subjects with at least 50 % reduction from Baseline to Treatment Period in Partial Onset Seizure frequency per week.
The Responder Rate for Partial Onset Seizures (Type I) is the proportion of subjects who have a >= 50 % reduction in seizure frequency per week from Baseline."|From Baseline to 12-week Treatment Period|The Intention-to-treat (ITT) population was defined as all randomized subjects who received at least 1 dose of study medication.||Percentage of Participants|||Number
742054|NCT00490035|Primary|Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period|Partial (Type I) Seizures can be classified into one of the following three groups: Simple Partial Seizures, Complex Partial Seizures, Partial Seizures evolving to Secondarily Generalized Seizures.|From Baseline to 12-week Treatment Period|The Intention-to-treat (ITT) population was defined as all randomized subjects who received at least 1 dose of study medication.||Seizure Frequency per Week||Inter-Quartile Range|Median
742055|NCT00490061|Secondary|Overall Survival.|Overall survival is the time from starting treatment until death due to any cause. For subjects who do not die, time to death will be censored at the time of last contact.|Two years survival rate after study enrollment|All enrolled participants.||percentage of participants|||Number
742056|NCT00490061|Primary|Progression Free Survival|"To determine the efficacy of combining lapatinib and radiotherapy in terms of Progression-free survival (PFS) in patients with locally advanced HNSCC who cannot tolerate concurrent chemoradiotherapy.
Progression-free survival is defined is the time from starting treatment to the time of first documented tumor progression or death due to any cause, which ever occurs first.
Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST V1.0) as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions."|2 year PFS: PFS at 2 yrs after study enrollment|All enrolled participants.||percentage of participants||95% Confidence Interval|Number
742057|NCT00490100|Primary|Change in Growth Rate on Study Drug|Growth rate on intervention is compared with growth rate before intervention for each participant.|During intervention, up to 2 years|Only participants who completed study||cm/year||Full Range|Median
742058|NCT00490100|Primary|Safety of Study Drug|Rates of adverse events related to study drug|1 year|||participants|||Number
742059|NCT00490139|Secondary|DFS Ignoring Non-breast Second Primary Malignancies|Disease-free survival is defined as the interval between randomization and the date of the first occurence of disease recurrence (local, regional or distant), a contralateral invasive breast cancer, a second primary cancer, or death from any cause. DFS was estimated using the Kaplan Meier method. The non-breast second primary malignancies were not considered events.The percentile data values presented here indicate the percentage (95, 90, 85, 80 and 75 percent) of participants who did not have DFS ignoring non-breast second primary malignancies for the indicated years. Zero participants were analyzed in the lapatinib arm, as the IDMC discontinued the lapatinib-alone arm due to futility at the time of the first interim analysis (lapatinib participants were then offered trastuzumab).|From randomization until the date of the first occurrence of disease recurrence, a contralateral invasive breast cancer, a second primary cancer, or death from any cause (median follow-up of 4.5 years)|ITT Population. Participants who did not have a recurrence of the initial disease, or did not die, were lost to follow-up, or were withdrawn from the study were censored at the date of last clinical contact. Non-breast second primary cancers were ignored.||years|||Number
742060|NCT00490139|Secondary|Time to Central Nervous System Recurrence|Time to central nervous system recurrence is defined as the time from randomization until the first central nervous system recurrence. Both brain metastasis and meningitis carcinomatosa were considered.The percentile data values presented here indicate that 95 percent of participants did not have central nervous system recurrence for the indicated years.|From randomization until the first central nervous system recurrence (median follow-up of 4.5 years)|ITT Population. Participants who did not have a central nervous system recurrence were censored at the date of the last recorded physical or radiological examination. Death was treated as a competing risk. Zero participants were analyzed in the lapatinib arm, as the IDMC discontinued the lapatinib-alone arm due to futility at the interim analysis.||years|||Number
742061|NCT00490139|Secondary|Time to Distant Recurrence|Time to distant recurrence is defined as the interval between the date of randomization and the date of the first occurrence of distant recurrence (including central nervous system recurrence). The percentile data values presented here indicate the percentage (95, 90, 85 and 80 percent) of participants who did not have distant recurrence for the indicated years.|From randomization until the date of the first occurrence of distant recurrence (median follow-up of 4.5 years)|ITT Population. Participants who did not have a distant recurrence of the initial disease were censored at the date of the last recorded physical or radiological examination. Death was treated as a competing risk. Zero participants were analyzed in the lapatinib arm, as the IDMC discontinued the lapatinib-alone arm due to futility.||years|||Number
742062|NCT00490139|Secondary|Time to Recurrence|Time to recurrence is defined as the interval between the date of randomization and the date of the first occurrence of a disease recurrence (local, regional or distant). The percentile data values presented here indicate the percentage (95, 90, 85, and 80 percent) of participants who did not have disease recurrence for the indicated years. IDMC=Independent Data Monitoring Committee.|From randomization until the date of the first occurrence of a disease recurrence (median follow-up of 4.5 years)|ITT Population. Participants who did not have a recurrence of the initial disease were censored at the date of the last recorded physical or radiological examination. Death was treated as a competing risk. Zero participants were analyzed in the lapatinib arm, as the IDMC discontinued the lapatinib-alone arm due to futility at the interim analysis.||years|||Number
742063|NCT00490139|Secondary|Overall Survival (OS)|Overall survival is defined as the time from randomization until death due to any cause. Overall survival was calculated in years as (date of death minus the date of randomization +1) divided by 365.25. The percentile data values presented here indicate the percentage (99, 98, 97, 96, 95 and 90 percent) of participants who survived for the indicated years.|From randomization until death due to any cause (median follow-up of 4.5 years)|ITT Population. Participants who did not die were censored at the date of last survival contact. Zero participants were analyzed in the lapatinib arm, as the Independent Data Monitoring Committee discontinued the lapatinib-alone arm due to futility at the time of the first interim analysis (lapatinib participants were then offered trastuzumab).||years|||Number
742064|NCT00490139|Primary|Disease-free Survival (DFS)|Disease-free survival is defined as the interval between randomization and the date of the first occurence of disease recurrence (local, regional or distant), a contralateral invasive breast cancer, a second primary cancer (SPC), or death from any cause. DFS was estimated using the Kaplan Meier method.The percentile data values presented here indicate the percentage (95, 90, 85, 80 and 75 percent) of participants who had disease free survival for the indicated years.|From randomization until the date of the first occurrence of disease recurrence, a contralateral invasive breast cancer, a second primary cancer, or death from any cause (median follow-up of 4.5 years)|Intent-to-Treat (ITT) Population: all randomized par., except for those who withdrew their consent to use any of their data prior to receiving any study medication. Par. with no recurrence of the initial disease or SPC, or who did not die, were lost to follow-up, or were withdrawn from the study were censored at the date of last clinical contact.||years|||Number
742065|NCT00490256|Primary|iFAB Post-op|intestinal fatty acid binding protein level immediately postop|Immediate postop|||mcg/ml||Standard Deviation|Mean
742066|NCT00490256|Secondary|Cerebral and Lower Body Near Infra-red Spectroscopy Measures||24 hours||||||
742067|NCT00490256|Primary|Intestinal Fatty Acid Binding Protein and C-reactive Protein||Baseline and 0, 3, 12, and 24 hours after surgery||||||
742073|NCT00490490|Primary|Complete Response (CR) Rate|"Participants assessed for by the following Complete Response (CR) criteria
CR or Functional CR
No evidence of disease and symptoms
Any macroscopic nodules detected in any organs no longer present.
Any palpable lymph node is normal and greatest diameter is < 1.0 cm.
The enlarged organs decreased in size and not palpable
The bone marrow biopsy and aspirate are negative for disease
Negative for disease by PET-scan (functional CR)
CR Unconfirmed (CRu) criteria
No evidence of disease and symptoms
Any lymph node mass > 1.0 cm^2 diameter has regressed is size by more than 75%.
No macroscopic nodules in any organs
Any palpable lymph node is normal and greatest diameter is < 1.0 cm.
The bone marrow biopsy and aspirate are negative for disease
The bone marrow biopsy may have increased number or size of lymphoid aggregates without cytologic or architectural atypia"|12 weeks|||percentage of participants|||Number
742074|NCT00490542|Primary|The Primary Outcome Measure Was Change in Montgomery-Asberg Depression Rating Scale (MADRS) Scores Over Weeks Between Groups.|Change in Montgomery-Asberg Depression Rating Scale score was compared between placebo and ziprasidone arms. The MADRS measures severity of depressive symptoms. The MADRS scale is from 0 (min) to 40 (max) with 0 being not depressed at all and 40 being the most severely depressed. 0 is the best outcome and 40 is the worst outcome.|Baseline to 6 weeks|Power analysis, with beta=0.20 and two-tailed alpha=0.05, was based on pilot studies for the mania registration trials which included mixed episodes and assessed MADRS scores. A projected standard error of the mean difference was assumed to be about twice as much as the mean difference (5-15 points), producing a sample size of about 100.||Scores on a scale||95% Confidence Interval|Mean
742075|NCT00490555|Secondary|Dehydroepiandrosterone (DHEA)||10 weeks|||ng/mL||Inter-Quartile Range|Median
742076|NCT00490555|Secondary|Androstenedione (AED)||10 weeks|||ng/mL||Inter-Quartile Range|Median
742077|NCT00490555|Primary|Dihydrotestosterone (DHT) Concentration||10 weeks|||ng/mL||Inter-Quartile Range|Median
742078|NCT00490555|Primary|Testosterone Concentration||10 weeks|||ng/mL||Inter-Quartile Range|Median
742079|NCT00490555|Primary|Prostate-specific Antigen (PSA)|PSA level week 10 end of treatment|10 weeks|||ng/mL||Inter-Quartile Range|Median
742080|NCT00490646|Primary|Number of Participants With Best Overall Response (BOR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1|BOR was the best response recorded from the start of treatment until disease progression or recurrence (taking the smallest measurement recorded since the start of treatment as reference). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the LD of all lesions. CR and PR criteria should be met again after 4 weeks and before 6 weeks after initial assessment. Stable disease (SD)=Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. Refer to Outcome Measure 3 for definition of PD.|Assessed every 6 weeks from initiation of study therapy up to 12 months; then every 3 months until disease progression (maximum time that any participant was on therapy was 108 weeks).|All randomized participants.||participants|||Number
742081|NCT00490646|Secondary|Number of Participants With Serum Chemistry Abnormalities by Worst Grade Per National Cancer Institure Common Terminology Criteria Adverse Events (NCI CTCAE), Version 3.0|Grading: NCI CTCAE, Version 3.0. GR1=mild, GR2=moderate, GR3=severe, GR4=life threatening or disabling. Normal ranges provided by local laboratory and may also vary by age and sex. Alkaline phosphatase (ALP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST): GR1=>ULN-2.5*ULN; GR2=>2.5-5.0*ULN; GR3=>5.0-20.0*ULN; GR4=>20.0*ULN. Total bilirubin: GR1=>ULN-1.5*ULN, GR2=>1.5-3.0*ULN, GR3=>3-10*ULN, GR4=>10*ULN. Creatinine: GR1=>ULN-1.5*ULN, GR2=>1.5-3.0*ULN, GR3=>3.0-6.0*ULN, GR4=>6.0*ULN. ULN=upper limit of normal.|Prior to every cycle of therapy (i.e. before starting of every 21 day or 3 week cycle; maximum time that any participant was on therapy was 108 weeks.)|Treated participants: Participants who received at least 1 dose of study therapy. n=number of participants with measures available.||participants|||Number
742082|NCT00490646|Secondary|Number of Participants With Hematology Abnormalities by Worst Grade Per National Cancer Institute Common Terminology Criteria Adverse Events (NCI CTCAE), Version 3.0|Grade (GR)1=mild, GR2=moderate, GR3=severe, GR4=life threatening or disabling. Normal ranges provided by local laboratory and may also vary by age and sex. White blood cell (WBC):GR1=<LLN-3.0*10^9/L; GR2=<3.0-2.0*10^9/L; GR3=<2.0-1.0*10^9/L; GR4=<1.0*10^9/L. Absolute Neutrophil Count (ANC):GR1=<LLN-1.5*10^9 /L; GR2=<1.5-1.0*10^9/L; GR3=<1.0-0.5*10^9/L; GR4=<0.5*10^9/L. Platelets:GR1=<LLN-75.0*10^9/L; GR2=<75.0-50.0*10^9/L; GR3=<50.0-25.0*10^9/L, GR4=<25.0*10^9/L. Hemoglobin:GR1=<LLN-10.0g/dL; GR2=<10.0-8.0g/dL; GR3=<8.0-6.5g/dL, GR4=<6.5g/dL. LLN=lower limit of normal.|Prior to every cycle of therapy (i.e. before starting of every 21 day or 3 week cycle; maximum time that any participant was on therapy was 108 weeks.)|Treated participants: Participants who received at least 1 dose of study therapy. n=number of participants with measures available.||participants|||Number
742083|NCT00490646|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs), and AEs Leading to Discontinuation of Study Therapy Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0|AE: New untoward medical occurrence or worsening of a preexisting medical condition that does not have causal relationship with this treatment. SAE: Untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, drug dependency/abuse; life-threatening, an important medical event, a congenital anomaly/birth defect; requires inpatient hospitalization/prolongs existing hospitalization. Grade 3=Severe; and Grade 4=Life-threatening or disabling. GR=Grade.|Assessed from the date of first dose until at least 30 days after the last dose of study drug (maximum time that any participant was on therapy was 108 weeks.)|Treated participants: Participants who received at least 1 dose of study therapy.||participants|||Number
742084|NCT00490646|Secondary|Duration of Response|"Period measured in months from time that measurement criteria were first met for CR or PR until first date of documented PD or death from any cause without prior documentation of progression.
PD=≥20% increase in sum of LD of target lesions in reference to smallest sum LD recorded at or following baseline or unequivocal progression of existing non-target lesion(s) overall. Refer to Outcome Measure 1 for definitions of CR and PR. Estimated by the Kaplan-Meier product limit method. A two-sided 95% CI for median duration was computed by Brookmeyer and Crowley method."|From the date of first PR or CR assessment to the date of documented progressive disease or death without prior documentation of progression (maximum participant duration of response of 38 months.)|All randomized participants with CR or PR. The participants who neither relapsed nor died were censored on the date of their last tumor assessment.||months||95% Confidence Interval|Median
748843|NCT00538642|Secondary|Diastolic Blood Pressure||Baseline|||mm Hg||Standard Deviation|Mean
742085|NCT00490646|Secondary|Time to Response|"Time to response was defined as the time in weeks from randomization until the measurement criteria are first met for a CR or PR, whichever is recorded first.
CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the LD of all lesions. CR and PR criteria should be met again after 4 weeks and before 6 weeks after initial assessment. Estimated by the Kaplan-Meier product limit method. A two-sided 95% CI for median duration was computed by the Brookmeyer and Crowley method."|From randomization every 6 weeks for first 12 months and thereafter every 3 months until CR or PR whichever was recorded first (maximum participant time to response of 18.4 weeks.)|All randomized participants with CR or PR.||weeks||Full Range|Median
742086|NCT00490646|Secondary|Progression Free Survival (PFS)|"Time in months from randomization until first date of documented progressive disease (PD) or death from any cause without prior documentation of progression. PD=≥20% increase in sum of LD of target lesions in reference to smallest sum LD recorded at or following baseline or unequivocal progression of existing non-target lesion(s) overall.
Estimated by the Kaplan-Meier product limit method. A two-sided 95% CI for median duration was computed by the Brookmeyer and Crowley method."|From randomization until the first date of documented progressive disease (PD) or death from any cause without prior documentation of progression (maximum participant PFS of 39.7 months).|All randomized participants. Participants who did not progress or died were censored on the date of their last tumor assessment.||months||95% Confidence Interval|Median
742087|NCT00490646|Primary|Percentage of Participants With Objective Response (OR; Assessed by Response Evaluation Criteria in Solid Tumors [RECIST] Version 1.1)|Percentage of participants with best overall response (BOR) of either complete response (CR) or partial response (PR) according to RECIST version 1.1 as determined by the investigator. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (LD) of all lesions. CR and PR criteria should be met again after 4 weeks and before 6 weeks after initial assessment. A two-sided confidence interval (CI) was computed using the Clopper-Pearson method.|Assessed every 6 weeks from initiation of study therapy up to 12 months; then every 3 months until disease progression (maximum time that any participant was on therapy was 108 weeks)|All randomized participants.||percentage of participants||95% Confidence Interval|Number
742088|NCT00490698|Primary|Median Time to First Skeletal-related Event|Time to skeletal events, defined as a metastatic site requiring radiotherapy or any surgical intervention (eg, embolization, radiofrequency ablation, intrathecal catheter placement) or complications from skeletal metastatic lesions (eg, pathologic fracture, spinal cord compression). Time to skeletal events monitored every 8 weeks for at least 1 year.|Up to 1 year|Four participants did not experience skeletal events.||months||95% Confidence Interval|Median
742089|NCT00490724|Secondary|Urinary Volume|The urinary volume was measured because nesiritide has a diuretic effect. Measurement of hour urine was done in the observation period and treatment period. 1-hour urine before treatment initiation was measured in the observation period. In the treatment period, 1-hour urine for period 1 and 3-hour urine for period 2 was measured. Urinary volume was recorded for participants without urethral catheterization having spontaneous micturition when needed.|Baseline, 3 and 24 hour|The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, n=the participants evaluated for this measure at a particular time point.||Millliter||Standard Deviation|Mean
742090|NCT00490724|Secondary|Assessment of Dyspnea Using Respiratory Rate|Assessment of dyspnea was done by measuring respiratory rate which is the number of times an organism breathes with the lungs (respiration) per unit time, usually per minute|Baseline, 1, 2, 3, 6, 9, 15 and 24 hour|The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, n=the participants evaluated for this measure at a particular time point.||Breaths Per Minute (BrPM)||Standard Deviation|Mean
742091|NCT00490724|Secondary|Assessment of Dyspnea Using Percutaneous Arterial Oxygen Saturation (SpO2)|Assessment of dyspnea was done by measuring SpO2 via pulse oximetry, by making the participant lye quietly in the post anesthesia care unit (PACU) and breathing room air (RA)|Baseline, 1, 2, 3, 6, 9, 12, 15 and 24 hour|The PPS were the residual participants having a significant protocol deviation influencing the efficacy assessment, obtained by subtracting from the FAS population. Here,n=the participants evaluated for this measure at a particular time point.||Percentage of SpO2||Standard Deviation|Mean
742092|NCT00490724|Secondary|Number of Participants With Oxygen Therapy|Assessment of dyspnea was done by measuring number of participants showing presence or absence of oxygen therapy.|Baseline,1 and 24 hour|The PPS were the residual participants having a significant protocol deviation influencing the efficacy assessment, obtained by subtracting from the FAS population. Here, N=the participants evaluated for this measure and n=the participants evaluated for this measure at a particular time point.||Participants|||Number
742093|NCT00490724|Secondary|Number of Participants With Orthopnea|Assessment of dyspnea was done by measuring percentage of participants showing presence or absence of orthopnea (it is the sensation of breathlessness in the recumbent position, relieved by sitting or standing) symptoms|Baseline, 1 and 24 hour|The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, N=the participants evaluated for this measure.||Participants|||Number
742094|NCT00490724|Secondary|Number of Participants With Dyspnea Symptoms Assessed by Likert Scale Score|Assessment of Dyspnea was done using Likert scale. It is a 7-point scale where following scores stands for severity of dyspnea: 1=markedly better; 2=moderately better; 3=minimally better; 4=no change; 5=minimally worse; 6=moderately worse and 7= markedly worse|3, 6 and 24 hour|The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, N=the participants evaluated for this measure.||Participants|||Number
742127|NCT00490841|Secondary|9 Month Blood Pressure (Systolic)|As compared to baseline (pre-procedure). Blood pressure measurements at 9 months.|Baseline (Pre-Procedure) and 9 months|The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||mmHg||95% Confidence Interval|Mean
744425|NCT00509392|Primary|Tenderness|Tenderness 0-10 scale (10 most severe)|1 Week|Data available at 1-week follow-up visit||units on a scale|limbs|Standard Deviation|Mean
742095|NCT00490724|Secondary|Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score|Assessment of Dyspnea (difficult or labored breathing) was done using Borg scale. It is a 10-point scale where following scores stands for severity of dyspnea: 0=no breathlessness at all; 0.5=very very slight (just noticeable); 1=very slight; 2=slight; 3=moderate; 4=somewhat severe; 5=severe; 7=very severe breathlessness; 9=very very severe (almost maximum) and 10=maximum.|Baseline, 1 h and 24 h|The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, N=the participants evaluated for this measure.||Participants|||Number
742096|NCT00490724|Secondary|Change From Baseline in Pulmonary Vascular Resistance (PVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The PVR (force that opposes the flow of blood through a vascular bed) was a calculated hemodynamic parameter and the calculation was done on the basis of the measured hemodynamic parameters. PVR was calculated by dividing (80*[MPAP−PCWP]) and CO.|Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, N=the participants evaluated for this measure and n=the participants evaluated for this measure at a particular time point.||dyne*second/centimeter^5||Standard Deviation|Mean
742097|NCT00490724|Secondary|Change From Baseline in Systemic Vascular Resistance (SVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12 and 24 Hour|The SVR was a calculated hemodynamic parameter and the calculation was done on the basis of the measured hemodynamic parameters. SVR was calculated by dividing (80*[MBP−MRAP]) and CO.|Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12 and 24 Hour|The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, N=the participants evaluated for this measure and n=the participants evaluated for this measure at a particular time point.||dyne*second per centimeter^5||Standard Deviation|Mean
742098|NCT00490724|Secondary|Change From Baseline in Stroke Volume Index (SVI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The SVI was a calculated hemodynamic parameter and the calculation was done on the basis of the measured hemodynamic parameters. Stroke volume is the volume of blood ejected from a ventricle at each beat of the heart, equal to the difference between the end-diastolic volume and the end-systolic volume. The stroke volume index is a method of relating the stroke volume to the size of the person by dividing the stroke volume by the body surface area (BSA).|Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, N=the participants evaluated for this measure and n=the participants evaluated for this measure at a particular time point.||milliliter per meter^2||Standard Deviation|Mean
742099|NCT00490724|Secondary|Change From Baseline in Stroke Volume (SV) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The SV was a calculated hemodynamic parameter and the calculation was done on the basis of the measured hemodynamic parameters. Stroke volume is the volume of blood ejected from a ventricle at each beat of the heart, equal to the difference between the end-diastolic volume and the end-systolic volume. SV was calculated by dividing CO and heart rate (HR).|Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, N=the participants evaluated for this measure and n=the participants evaluated for this measure at a particular time point.||milliliter (ml)||Standard Deviation|Mean
742100|NCT00490724|Secondary|Change From Baseline in Cardiac Index (CI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The CI was a calculated hemodynamic parameter and the calculation was done on the basis of the measured hemodynamic parameters. CI was calculated by dividing CO and body surface area.|Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, n=the participants evaluated for this measure at a particular time point.||Liter per minute per meter^2 (l/min/m^2)||Standard Deviation|Mean
742101|NCT00490724|Secondary|Change From Baseline in Mean Blood Pressure (MBP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24 Hour|The MBP was a calculated hemodynamic parameter and the calculation was done on the basis of the measured hemodynamic parameters. MBP was calculated as sum of diastolic blood pressure (DBP) and (0.33*[SBP−DBP])|Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24 Hour|The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, n=the participants evaluated for this measure at a particular time point.||Millimeters of mercury||Standard Deviation|Mean
742102|NCT00490724|Secondary|Change From Baseline in Cardiac Output (CO) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The CO was a measured cardiopulmonary hemodynamic parameter. It is the volume of blood expelled by the ventricles of the heart with each beat. It was calculated as the product of stroke volume (output of either ventricle per heartbeat) and the number of beats per minute. Cardiac output is commonly measured by the thermodilution technique.|Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, n=the participants evaluated for this measure at a particular time point.||Liter per minute||Standard Deviation|Mean
742128|NCT00490841|Secondary|Event Free Rate of Clinically Indicated Target Lesion Revascularization (TLR)|Event Free percentage: Defined as percentage of participants free from this event.|9 months|The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||Event Free Percentage|||Number
742129|NCT00490841|Secondary|Embolic Events Resulting in Kidney Damage|Percentage of participants with an embolic event resulting in kidney damage.|30 days|The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||Percentage of participants||95% Confidence Interval|Number
745615|NCT00517192|Secondary|Response up to 48 Weeks Using VL < 50 Copies/mL Using NCF||up to 48 weeks||||||
742103|NCT00490724|Secondary|Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The PCWP was a measured hemodynamic parameter. It was the blood pressure, recorded after wedging a catheter in a small pulmonary artery; believed to reflect the pressure in the pulmonary capillaries. It was measured by pulmonary artery catheterization and provided an indirect measure of left atrial pressure.|Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, N=the participants evaluated for this measure and n=the participants evaluated for this measure at a particular time point.||Millimeters of mercury||Standard Deviation|Mean
742104|NCT00490724|Secondary|Change From Baseline in Mean Pulmonary Arterial Pressure (MPAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The MPAP was a measured hemodynamic parameter. MPAP was measured using a Swan-Ganz catheter.|Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, n=the participants evaluated for this measure at a particular time point.||Millimeters of mercury||Standard Deviation|Mean
742105|NCT00490724|Secondary|Change From Baseline in Pulmonary Arterial Diastolic Pressure (PADP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The PADP was a measured hemodynamic parameter. Normal range of PADP is 8 to 15 millimeters of mercury (mmHg). PADP was assessed by Swan-Ganz catheter.|Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, n=the participants evaluated for this measure at a particular time point.||Millimeters of mercury||Standard Deviation|Mean
742106|NCT00490724|Secondary|Change From Baseline in Pulmonary Arterial Systolic Pressure (PASP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The PASP was a measured hemodynamic parameters. PASP was assessed by Swan-Ganz catheter.|Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, n=the participants evaluated for this measure at a particular time point.||Millimeters of mercury||Standard Deviation|Mean
742107|NCT00490724|Secondary|Change From Baseline in Mean Right Atrial Pressure (MRAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 15 and 24 Hour|The MRAP was a measured hemodynamic parameter. MRAP was measured using a Swan-Ganz catheter.|Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 15 and 24 Hour|The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, N=the participants evaluated for this measure and n=the participants evaluated for this measure at a particular time point.||Millimeters of mercury||Standard Deviation|Mean
742108|NCT00490724|Primary|Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP or Pulmonary Arterial Diastolic Pressure[PADP]) at 3 Hours|Change in PCWP was unmeasurable, therefore it was complemented with PADP. PCWP was measured by pulmonary artery catheterization and provided an indirect measure of left atrial pressure.|Baseline and 3 Hours|The per protocol set (PPS) included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations.||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
742109|NCT00490802|Secondary|Social Responsiveness Scale|The Social Responsiveness Scale has been developed to measure autism related symptoms and focuses more on social function than social cognition. The Social Responsiveness Scale has been modified for adults by and we have obtained permission to use the adult scale, although it is not commercially available yet. The Social Responsiveness Scale measures social behaviors such as social awareness, information processing, and social motivation and yields a quantitative score that has been useful in endophenotype studies of Autism Spectrum Disorder. The minimum score that can be obtained is a 0 and the maximum raw score for subscales is 66, maximum total raw score is 153. A lower score represents a positive response.|6 Weeks|||units on a scale||Standard Deviation|Mean
742110|NCT00490802|Secondary|Yale-Brown Obsessive-Compulsive Scale|The Yale-Brown Obsessive-Compulsive Scale is a clinician-rated questionnaire measuring the time spent, distress, interference, resistance, and control in relation to obsessions and compulsions based on a 5-point scale. This scale has excellent reliability and validity and is used as the gold standard to measure treatment challenges in all Obsessive-Compulsive Disorder clinical trials. The Yale-Brown Obsessive-Compulsive Scale Compulsion Subscale has been shown to be a reliable and valid scale in Autism Spectrum Disorder, and in measuring change in treatment studies of autism. The minimum score that can be obtained is 0 and the maximum score is 20. A lower score represents a positive response.|6 Weeks|||units on a scale||Standard Deviation|Mean
742111|NCT00490802|Primary|Diagnostic Analysis of Nonverbal Accuracy, Paralanguage Test|The Diagnostic Analysis of Nonverbal Accuracy is a measure of emotion recognition across multiple modalities. It consists of five subtests: the Adult Facial Expression Test, the Child Facial Expression Test, the Adult Paralanguage Test, the Child Paralanguage Test, and the Adult Posture Test. The Diagnostic Analysis of Nonverbal Accuracy has established reliability and validity for children as young as 3 and adults as old as 100. The subtests of the test vary on four basic core emotions: happiness, sadness, anger, and fear, and the test provides measures of both high intensity and low intensity emotional reactions. We utilized both the Child Paralanguage and Adult Paralanguage Tests, therefore the minimum score that can be obtained is 0 and the maximum is 48. A higher score represents a positive response.|6 Weeks|||units on a scale||Standard Deviation|Mean
742130|NCT00490841|Secondary|Ipsilateral Nephrectomy|Ipsilateral: Situated on or affecting the same side as treated. Nephrectomy: Removal of the affected kidney|30 days|intention to treat (ITT). The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||percentage of participants||95% Confidence Interval|Number
742131|NCT00490841|Secondary|Death for Any Reason||30 days|Non-Hierarchical Subject Counts, Per Subject Analysis (Intent-to-Treat Population). The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||percentage of participants||95% Confidence Interval|Number
742112|NCT00490802|Primary|Repetitive Behavior Scale - Revised|"The Repetitive Behavior Scale - Revised was developed to capture the breadth of repetitive behaviors that are specific to autism and is a parent report measure. In particular, it consists of 43-items that tap six repetitive behavior subtypes: Stereotyped, Self-injurious, Compulsive, Ritualistic, Sameness, and Restricted Interests.
Two scores were calculated (higher-order vs. lower-order repetitive behaviors) in an effort to decrease the number of variables analyzed. This is based on previous factor analysis that produced these two factors: higher order (ritualistic, sameness, compulsive and restricted subscales) and lower order (stereotypy and self-injury).
The higher order behaviors have 29 items that can be endorsed with a maximum score of 87 and a minimum score of 0
The lower order behaviors have 14 items that can be endorsed, with a maximum score of 42 and a minimum score of 0
In both cases, a lower score represents a positive response."|6 Weeks|||units on a scale||Standard Deviation|Mean
742113|NCT00490802|Primary|Clinical Global Impressions Scale - Improvement - Social|"The Clinical Global Impressions Scale - Improvement - Social is a well validated measure employing a 7-point scale of clinical global impression of improvement ( 1- very much improved, 2 - much improved, 3 - minimally improved, 4 - no change, 5 - minimally worse, 6 - much worse, 7 - very much worse) that the clinician fills out after considering all the available information on the participant including the parent history, the examination in clinic, reports from the school and other sources. Therefore the score is filtered through the judgment of the clinician evaluator.
The Week 6 Improvement Ratings were used to categorize patients as clinically improved (≤2) or not (>2). Sixteen of the 19 patients (84%) had data at Week 6. For the remaining three subjects, Week 6 ratings were imputed using expectation-maximization methods and the earlier Clinical Global Impression ratings. In all three cases the imputed ratings were >2 and the patients were classified as not improved."|6 Weeks|||participants|||Number
742114|NCT00490815|Secondary|Retinal Thickness||over 36 months|||µg||Standard Deviation|Mean
742115|NCT00490815|Primary|Levels of Fluocinolone Acetonide in Plasma and Aqueous Humor|This was a combined assessment of the levels of fluocinolone acetonide in the plasma and aqueous humor. The average values of the data collected is entered in Outcome Data.|over 36 months|||pg/ml||Standard Deviation|Mean
742116|NCT00490841|Secondary|Renal Function (Measured by sCr)|"sCR= Serum Creatinine, per subject analysis. ITT. Renal function (measured by sCr) @ baseline: 1.2mg/dL (1.2, 1.3).
The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|9 months|Subject total reflects those who were evaluable at the time of analysis.||mg/dL||95% Confidence Interval|Mean
742117|NCT00490841|Secondary|9 mo in Anti-hypertensive Medication In-take, ≥ 4 Medications|"Number of Anti-Hypertensive Medications taken at follow up compared to baseline, Per Subject Analysis (Intent-to-Treat Population)), reported as the percentage of participants using the number of medications indicated.
The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|9 months|Patients with baseline Anti-Hypertensive medication intake equal to or greater than 4 Medications: 39.6%||percentage of participants|||Number
742118|NCT00490841|Secondary|9 Month Anti-hypertensive Medication In-take, 3 Medications|"Number of Anti-Hypertensive Medications taken-baseline compared to follow up, Per Subject Analysis (Intent-to-Treat Population)), reported as the percentage of participants using the number of medications indicated.
The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|9 months|Patients with baseline Anti-Hypertensive medication intake equal to 3 Medications: 30.7%||percentage of participants|||Number
742119|NCT00490841|Secondary|9 Month Anti-hypertensive Medication In-take, 2 Medications|"Number of Anti-Hypertensive Medications taken-baseline compared to follow up, Per Subject Analysis (Intent-to-Treat Population)), reported as the percentage of participants using the number of medications indicated.
The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|9 months|Patients with baseline Anti-Hypertensive medication intake equal to 2 medications: 29.2%||percentage of participants|||Number
742120|NCT00490841|Secondary|9 Month Anti-hypertensive Medication In-take, 1 Medication|"Number of Anti-Hypertensive Medications taken-baseline compared to follow up, Per Subject Analysis (Intent-to-Treat Population), reported as the percentage of participants using the number of medications indicated.
The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|9 months|Patients with baseline Anti-Hypertensive medication intake equal to 1 medication: 0.5%||percentage of participants|||Number
742121|NCT00490841|Secondary|Secondary Patency Rate of <60% Stenosis of the Target Lesion|"As determined by duplex ultrasound or angiography regardless of PTA, stenting, or bypass since index procedure. Rate reported as a percentage of participants with this condition.
The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|9 months|Subject total reflects those who were evaluable at the time of analysis.||percentage of participants|Participants|95% Confidence Interval|Number
742122|NCT00490841|Secondary|Primary Patency|"Defined as <60% stenosis without prior re-intervention, as determined by duplex ultrasound or angiogram.
The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|9 months|Subject total reflects those who were evaluable at the time of analysis.||percentage of participants|Participants|95% Confidence Interval|Number
742123|NCT00490841|Secondary|Acute Clinical Success|"Procedure success without Major Adverse Events (MAE)or access site event requiring surgical or percutaneous intervention prior to hospital discharge.
The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|From beginning of index proceedure to end of index proceedure.|||percentage of participants||95% Confidence Interval|Number
742124|NCT00490841|Secondary|Acute Procedure Success|Attainment of a final result of < 30% residual stenosis, as determined by the Angiographic Core Lab.|From beginning of index proceedure to end of index proceedure.|||percentage of participants|Participants|95% Confidence Interval|Number
742125|NCT00490841|Secondary|Acute Device Success|Acute device success is defined as, on a per device basis, the achievement of successful delivery of the assigned device(s)as intended to the designated location.|From beginning of index procedure to end of index proceedure.|||percentage of devices|Participants|95% Confidence Interval|Number
744426|NCT00509392|Primary|Tenderness|Tenderness 0-10 scale (10 most severe)|48 Hour|Data available at 48hr visit||units on a scale|limbs|Standard Deviation|Mean
742132|NCT00490841|Primary|Binary Restenosis Rate|Determined by duplex ultrasound or angiogram. Reported as the percentage of participants with occurance of binary restenosis.|9 months|Subject total reflects those who were evaluable at the time of analysis. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician. Only a certain number of patients were required to have angiographic follow-up to provide this endpoint information.||Percentage of lesions|Participants|95% Confidence Interval|Number
742133|NCT00490919|Secondary|The Sleep Disturbance Subscale in the Medical Outcome Study (MOS) Sleep Scale at Weeks 4, 8, and 12 of the Double-blind Phase|The MOS Sleep Scale consists of 12 individual items (4 sleep disturbance, 2 sleep adequacy, 1 quantity of and optimal sleep, 3 somnolence, 1 snoring, and 1 shortness of breath) and takes 5 to 10 minutes to complete. Question 1 is scored on a scale of 1 to 5 and Questions 2 to 12 are scored on a scale of 1 to 6. The Sleep Disturbance Subscale score is derived from the scores to Questions 1, 3, 7 and 8, and ranges from 0 to 100, where higher scores indicate greater sleep disturbance.|Weeks 4, 8, 12 of double-blind phase|The full analysis population (FAP) (N = 541) consisted of subjects who were randomized and received at least 1 dose of the double-blind study drug. 2 subjects did not have safety data (N = 539).||Units on a scale||Standard Deviation|Mean
742134|NCT00490919|Secondary|The Mean Daily Number of Tablets of Nonopioid Supplemental Analgesic Medications Taken During Weeks 2 Through 12 of the Double-blind Phase|Nonopioid supplemental analgesic tablets were sponsor-supplied acetaminophen or ibuprofen.|weeks 2-12|Subjects in the full analysis population who took at least one dose of supplemental analgesic medication.||tablets||Standard Error|Mean
742135|NCT00490919|Primary|Average Pain Over the Last 24 Hours Scores at Week 12 of the Double-blind Phase.|Pain was assessed on an 11-point numerical scale ranging from 0 = no pain to 10 = pain as bad as you can imagine.|Prerandomization phase consisted of a 6-10 day screening period and a <27 day open-label run-in period; and a 12-week double-blind phase.|The full analysis population (FAP) (N = 541) [539] consisted of subjects who were randomized and received at least 1 dose of the double-blind study drug. (Two subjects did not have safety data.)||Units on a scale||Standard Deviation|Mean
742136|NCT00490945|Secondary|VEC-162 Tmax||Night 4|||hour||Standard Deviation|Mean
742137|NCT00490945|Secondary|VEC-162 Cmax||Night 4|||ng/mL||Standard Deviation|Mean
742138|NCT00490945|Secondary|VEC-162 AUC||Night 4|||ng*hr/mL||Standard Deviation|Mean
742139|NCT00490945|Secondary|Wake After Sleep Onset (WASO), and Latency to Persistent Sleep (LPS)|"Wake After Sleep Onset is defined as the total time that is scored as awake in a PSG occurring between sleep onset and lights-on prompt.
Latency to Persistent Sleep is defined as the number of epochs (one 30-second interval of the sleep episode) from the beginning of the recording (lights-out) to the start of persistent sleep (first 20 consecutive non-wake state) divided by 2."|Night 2 and Night 4|*Placebo N = 7 and 100 mg VEC-162 N = 7||minutes||Standard Deviation|Mean
742140|NCT00490945|Primary|Mean Sleep Efficiency|Exposure response was measured by comparing the change in sleep efficiencies of VEC-162 and placebo treated subjects upon a sleep schedule phase advance. Sleep efficiency (total time asleep divided by the time allowed as an opportunity for sleep in a period multiplied by 100%, where time allowed for sleep was 8 hours or 480 minutes) was measured objectively by overnight polysomnographic recordings. Sleep efficiency was also compared in parts of the night by dividing the full night into thirds.|Night 4 and Night 2|"*N = 6 for 3rd Third of Night Efficiency and N=8 for 1st Third of Night Efficiency
**N = 7 for 3rd Third of Night Efficiency"||% points||Standard Deviation|Mean
742141|NCT00490945|Primary|Circadian Phase Shift|Exposure response to VEC-162 on induction of circadian phase shift as measured by Dim Light Melatonin Onset (DLMO) was defined as the time change between Night 3 and Night 4 when melatonin production reached 25% of the maximum melatonin concentration. Samples below LOQ of the melatonin assay were assigned 5 pg/ml.|Night 3 and Night 4|||Hours||Standard Deviation|Mean
742142|NCT00490971|Other Pre-specified|Clinical Global Impression - Bipolar Disorder - Severity of Illness (CGI-BP-S): Change From Baseline|The CGI-BP-S rating scale is used to rate the severity of bipolar disorder, including both depressed and manic components, on a 7-point scale ranging from 1 (not ill) to 7 (very severely ill). This scale permits a global evaluation of the subject’s bipolar condition at a given time. Negative Change in Score Indicates Improvement.|From 1st randomization into acute phase to end of acute/continuation phase (ie, up to 15 weeks after 1st randomization), or from randomization into maintenance (MA) phase to the end of MA phase (ie, up to 175 weeks (or 41 months) after 2nd randomization).|Intent-to-Treat||Scores on the scale||Full Range|Median
742143|NCT00490971|Other Pre-specified|Global Assessment of Functioning (GAF): Change From Baseline|This scale is used when the clinical progress of a subject needs to be assessed in global terms, using a single measure. The GAF scale is rated with respect to psychological, social, and occupational functioning at the time of the assessment only. A higher score indicates a better functioning, with an overall range from 1 to 100. Positive Change in Score Indicates Improvement.|From 1st randomization into acute phase to end of acute/continuation phase (ie, up to 15 weeks after 1st randomization), or from randomization into maintenance (MA) phase to the end of MA phase (ie, up to 175 weeks (or 41 months) after 2nd randomization).|Intent-to-Treat||Scores on the scale||Standard Deviation|Mean
742144|NCT00490971|Other Pre-specified|Montgomery-Asberg Depression Rating Scale (MADRS)|The MADRS consists of 10 items covering all the important complaints which patient with depression have (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts). Item is scored from 0 (normal) to 6 (severe). Total score (0 to 60) is calculated by adding the scores of all 10 items. A higher score represents a more severe condition. Negative Change in Score Indicates Improvement.|From 1st randomization into acute phase to end of acute/continuation phase (ie, up to 15 weeks after 1st randomization), or from randomization into maintenance (MA) phase to the end of MA phase (ie, up to 175 weeks (or 41 months) after 2nd randomization).|Intent-to-Treat||Scores on the scale||Standard Deviation|Mean
742167|NCT00491556|Secondary|Difference in CD8 TEMRa HLA-DR Percentage Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TEMRa HLA-DR percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.||percentage of CD8 TEMRa HLA-DR T cells||Standard Deviation|Mean
744427|NCT00509392|Primary|Pain|Pain 0-10 scale (10 most severe)|1 Month|Data available at 1 month follow-up visit||units on a scale|limbs|Standard Deviation|Mean
742145|NCT00490971|Other Pre-specified|Young Mania Rating Scale (YMRS): Change From Baseline|This is method by which condition of patient suffering with mania is checked. In this scale patient's condition is assessed using 11 items. A severity rating is assigned to each of 11 items based on the how subject feels of his or her condition and the physicians observation of patients behavior. The range of the scale is 0 to 60. A higher score indicates a more severe condition. Change from baseline (Day 105) in the double‑blind maintenance phase to the last postbaseline assessment.|From 1st randomization into acute phase to end of acute/continuation phase (ie, up to 15 weeks after 1st randomization), or from randomization into maintenance (MA) phase to the end of MA phase (ie, up to 175 weeks (or 41 months) after 2nd randomization).|Intent-to-Treat||Scores on the scale||Standard Deviation|Mean
742146|NCT00490971|Secondary|Time to Recurrence of Depressive Symptoms Associated With Bipolar I Disorder|Pali/Pali and Pali/Placebo were compared with each other with respect to time to recurrence of depressive symptoms. The criterias used for this analysis were similar to criterias used for primary analysis.|Date of randomization into the maintenance phase until the first occurrence of recurrence of depressive symptoms or discontinuation from the study, assessed over a period of 41 months.|Intent-to-treat analysis set in MA period, which included participants who entered the maintenance phase and took at least 1 dose of study medication.||Days||95% Confidence Interval|Number
742147|NCT00490971|Secondary|Time to Recurrence of Manic Symptoms Associated With Bipolar I Disorder|This was the key secondary efficacy end-point. Pali/Pali and Pali/Placebo were compared with each other with respect to time to recurrence of manic symptoms. The criterias used for this analysis were similar to criterias used for primary analysis.|Date of randomization into the maintenance phase until the first occurrence of recurrence of manic symptoms or discontinuation from the study, assessed over a period of 41 months.|Intent-to-treat analysis set in MA phase, which included participants who entered the MA phase and took at least 1 dose of study medication.||Days||95% Confidence Interval|Number
742148|NCT00490971|Primary|Time to Recurrence of Any Mood Symptoms (Manic or Depressive) Associated With Bipolar I Disorder|Time to first recurrence of any mood symptoms (ie, manic or depressive) associated with bipolar I disorder during the maintenance phase, after maintaining clinical stability during continued treatment with paliperidone ER over a period of 15 weeks. The time period was from occurrence of acute manic or mixed episode to Week 15. This outcome was measured using combination of various scales, hospitalization for any mood symptoms, use of any medicines for an mood episode and clinical events suggestive of recurrent mood episode associated with bipolar I disorder.|Date of randomization into the maintenance phase until the first occurrence of recurrence of any symptoms or discontinuation from the study, assessed over a period of 41 months.|Intent-to-treat analysis set (ITT) in maintenance (MA) phase, which included participants who entered the MA phase and took at least 1 dose of study medication.||Days||95% Confidence Interval|Number
742149|NCT00491075|Primary|Overall Response|Number of participants with complete or partial response. Response Evaluation Criteria in Solid Tumors (RECIST) of Complete Response: disappearance all target lesions; Partial Response: >30% decrease in sum of longest diameter (LD) of target lesions, reference baseline sum LD; Progressive Disease: >20% increase sum of LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of 1 or > new lesions; Stable Disease: Insufficient shrinkage for partial response, or insufficient increase for progressive disease, reference smallest sum LD since treatment started.|Baseline to 8 weeks (after 4 cycles) protocol response at 16 weeks|One participant did not meet the required 16 week data end point and was excluded from the response evaluation and analysis.||percentage of participants||95% Confidence Interval|Number
742150|NCT00491179|Secondary|Number of Participants With Histologic Response(HR)|Number of participants with histologic response (HR): number of patients who had improvement of as least 2 scores at the end of follow-up liver biopsy compared to baseline liver biopsy by Ishak scoring system (the sum of Ishak necroinflammation score (0-18) and Ishak fibrosis score (0-6); the higher the total scores, the severer the histologic changes)|1.5 year|||Participants|||Number
742151|NCT00491179|Primary|1.Number of Participants With Sustained Virologic Response (SVR) 2.Number of Participants Who Droppoed Out of the Study Prematurely Due to Adverse Events (AEs)|"Number of participants with sustained virologic response (SVR): number of patients with undetectable HCV RNA 6 months off therapy by real-time PCR test (Cobas TaqMan HCV Test v2.0, Roche Diagnostics GmbH, Mannheim, Germany, limit of detection < 25 IU/mL)
Number of participants who droppoed out of the study prematurely due to adverse events (AEs): number of patients who prematurely withdrew from the study due to any adverse events"|1.5 year|Outcome measures:intention-to-treat (ITT) analysis Imputation technique: last observation carried forward||Participants|||Number
742152|NCT00491244|Secondary|Adverse Event (AE)-Related Withdrawal Rate||1.5 year|All patients were analyzed if they received at least one dose of the study medication; monitoring the events until the last visit||participants|||Number
742153|NCT00491244|Primary|Sustained Virologic Response (SVR)Rate||1.5 year|All participants were analyzed if they received at least one dose of the study medication||participants|||Number
742154|NCT00491374|Primary|The Change From Baseline in the Number of Apnea-hypopnea Episodes Per Hour (Apnea-hypopnea Index (AHI)|||The primary outcome measure could not be assessed because no subject received randomized treatment assignment, or any treatment. The study was terminated.|||||Number
742155|NCT00491387|Primary|Improved Sympathetic Cardiac Innervation.||6 months|||participants|||Number
742156|NCT00491400|Secondary|Serum Lipids|Effect of the intervention on total cholesterol, HDL, and triglycerides|8 weeks|Enrollment was insufficient and there are too few subjects for meaningful analysis|||||
742157|NCT00491400|Primary|Brachial Artery Flow-mediated Dilation|Endothelial function was assessed as brachial artery flow-mediated dilation (FMD) using ultrasound. FMD is calculated as the difference in brachial diameter during hyperemic flow and brachial diameter at baseline divided by brachial diameter at baseline and expressed as percent dilation.|8 weeks|The number of participants is too few for meaningful analysis.|||||
742168|NCT00491556|Secondary|Difference in CD8 TEMRa CD57 Percentage Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TEMRa CD57 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.||percentage of CD8 TEMRa CD57cells||Standard Deviation|Mean
744428|NCT00509392|Primary|Pain|Pain 0-10 scale (10 most severe)|2 Weeks|Data available at 2-week follow-up visit||units on a scale|limbs|Standard Deviation|Mean
742158|NCT00491504|Primary|Changes in the Total Nasal Symptom Severity Score (TNSS) at 6 Hours After Dosage Administration on Day 1|Value at 6 hours after dosage administration (Day 1) minus value at Baseline. Minimum threshold TNSS response defined as TNSS score ≥6 out of a possible 12 for combined nasal symptoms of congestion, sneezing, rhinorrhea & itching with a score ≥2 for nasal congestion. Rating of the severity of the individual signs/symptoms according to the following scale: 0=None, sign/symptom wasn't present; 1=Mild, sign/symptom was present, but not disturbing; 2=Moderate, sign/symptom definitely present, & disturbing some of the time; 3=Severe: sign/symptom very noticeable & very bothersome most of the time.|Baseline and 6 hours following initial dosing|Intent to treat population||score on a scale||Standard Error|Least Squares Mean
742159|NCT00491530|Secondary|Mean Percent Change in Total Cholesterol (Total-C) From Baseline to Week 104 of This Open-Label Year 2 Study|[(Week 104 Total-C minus baseline Total-C)/baseline Total-C] X 100. Baseline is the last value prior to the first dose of combination therapy.|Baseline to Week 104 (may include weeks in preceding double-blind studies [combination treatment arms], plus 52 weeks in preceding open-label year 1 study, and open-label year 2 study, up to 104 weeks)|Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies or preceding open-label year 1 study, and in this open-label year 2 study. Only subjects with a combination therapy baseline value and postbaseline value at Week 104 are included.||percent change||Standard Deviation|Mean
742160|NCT00491530|Secondary|Mean Percent Change in Very Low-Density Lipoprotein Cholesterol (VLDL-C) From Baseline to Week 104 of This Open-Label Year 2 Study|[(Week 104 VLDL-C minus baseline VLDL-C)/baseline VLDL-C] X 100. Baseline is the last value prior to the first dose of combination therapy.|Baseline to Week 104 (may include weeks in preceding double-blind studies [combination treatment arms], plus 52 weeks in preceding open-label year 1 study, and open-label year 2 study, up to 104 weeks)|Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies or preceding open-label year 1 study, and in this open-label year 2 study. Only subjects with a combination therapy baseline value and postbaseline value at Week 104 are included.||percent change||Standard Deviation|Mean
742161|NCT00491530|Secondary|Mean Percent Change in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Week 104 of This Open-Label Year 2 Study|[(Week 104 Non-HDL-C minus baseline Non-HDL-C)/baseline Non-HDL-C] X 100. Baseline is the last value prior to the first dose of combination therapy.|Baseline to Week 104 (may include weeks in preceding double-blind studies [combination treatment arms], plus 52 weeks in preceding open-label year 1 study, and open-label year 2 study, up to 104 weeks)|Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies or preceding open-label year 1 study, and in this open-label year 2 study. Only subjects with a combination therapy baseline value and postbaseline value at Week 104 are included.||percent change||Standard Deviation|Mean
742162|NCT00491530|Secondary|Mean Percent Change in Direct Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 104 of This Open-Label Year 2 Study|[(Week 104 LDL-C minus baseline LDL-C)/baseline LDL-C] X 100. Baseline is the last value prior to the first dose of combination therapy.|Baseline to Week 104 (may include weeks in preceding double-blind studies [combination treatment arms], plus 52 weeks in preceding open-label year 1 study, and open-label year 2 study, up to 104 weeks)|Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies or preceding open-label year 1 study, and in this open-label year 2 study. Only subjects with a combination therapy baseline value and postbaseline value at Week 104 are included.||percent change||Standard Deviation|Mean
742163|NCT00491530|Secondary|Mean Percent Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 104 of This Open-Label Year 2 Study|[(Week 104 HDL-C minus baseline HDL-C)/baseline HDL-C] X 100. Baseline is the last value prior to the first dose of combination therapy.|Baseline to Week 104 (may include weeks in preceding double-blind studies [combination treatment arms], plus 52 weeks in preceding open-label year 1 study, and open-label year 2 study, up to 104 weeks)|Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies or preceding open-label year 1 study, and in this open-label year 2 study. Only subjects with a combination therapy baseline value and postbaseline value at week 104 are included.||percent change||Standard Deviation|Mean
742164|NCT00491530|Secondary|Median Percent Change in Triglycerides From Baseline to Week 104 of This Open-Label Year 2 Study|[(Week 104 triglycerides minus baseline triglycerides)/baseline triglycerides] X 100. Baseline is the last value prior to the first dose of combination therapy.|Baseline to Week 104 (may include weeks in preceding double-blind studies [combination treatment arms], plus 52 weeks in preceding open-label year 1 study, and open-label year 2 study, up to 104 weeks)|Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies or preceding open-label year 1 study, and in this open-label year 2 study. Only subjects with a combination therapy baseline value and postbaseline value at Week 104 are included.||percent change||Full Range|Median
742165|NCT00491530|Primary|Percentage of Subjects Reporting Adverse Events During Combination Therapy in the Preceding Double-Blind Studies or in the Preceding Open-Label Year 1 Study or in This Open-Label Year 2 Study|All serious and non-serious adverse events are reported from the time of combination study drug initiation until 30 days after discontinuation of study drug. Adverse events are unfavorable changes in health that occur in subjects during a clinical trial or within a specified period following a trial. Serious adverse events are those that result in death, require inpatient hospitalization or the prolongation of hospitalization, result in congenital anomaly/birth defect, or significant disability/incapacity or are life-threatening.|Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) up to 116 weeks, to within 30 days after the last dose of combination therapy.|Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies or preceding open-label year 1 study, and in this open-label year 2 study. All adverse events in the preceding studies or in this study occurring with exposure to combination therapy are summarized.||percentage of participants|||Number
742166|NCT00491556|Secondary|Difference in CD8 TEMRa HLA-DR Percentage Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TEMRa HLA-DR percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.||percentage of CD8 TEMRa HLA-DR T cells||Standard Deviation|Mean
744429|NCT00509392|Primary|Pain|Pain 0-10 scale (10 most severe)|1 Week|Data available at 1-week follow-up visit.||units on a scale|limbs|Standard Deviation|Mean
742169|NCT00491556|Secondary|Difference in CD8 TEMRa CD57 Percentage Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TEMRa CD57 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.||percentage of CD8 TEMRa CD57 cells||Standard Deviation|Mean
742170|NCT00491556|Secondary|Difference in CD8 TEMRa CD38 Percentage Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TEMRa CD38 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.||percentage of CD8 TEMRa CD38 cells||Standard Deviation|Mean
742171|NCT00491556|Secondary|Difference in CD8 TEMRa CD38 Percentage Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TEMRa CD38 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.||percentage of CD8 TEMRa CD38 cells||Standard Deviation|Mean
742172|NCT00491556|Secondary|Difference in CD8 TEMRa CD28 Percentage Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm.Two subjects did not have enough blood samples to measure CD8 TEMRa CD28 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.||percentage of CD8 TEMRa CD28 cells||Standard Deviation|Mean
742173|NCT00491556|Secondary|Difference in CD8 TEMRa CD28 Percentage Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm.Three subjects did not have enough blood samples to measure CD8 TEMRa CD28 percentage, therefore the number of participants analyzed was reduced from 25 to 22 participants.||percentage of CD8 TemRA CD28 cells||Standard Deviation|Mean
742174|NCT00491556|Secondary|Difference in CD8 TEMRo HLA-DR Percentage Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TEMRo HLA-DR percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.||percentage of CD8 TEMRo HLA-DR cells||Standard Deviation|Mean
742175|NCT00491556|Secondary|Difference in CD8 TEMRO HLADR Percentage Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TEMRO HLADR percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.||percentage of CD8 TEMRO HLADR||Standard Deviation|Mean
742176|NCT00491556|Secondary|Difference in CD8 TEMRo CD57 Percentage Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TEMRo CD57 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.||percentage of CD8 TEMRo CD57 cells||Standard Deviation|Mean
742177|NCT00491556|Secondary|Difference in CD8 TEMRo CD57 Percentage Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TEMRo CD57 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.||percentage of CD8 TEMRo CD57 cells||Standard Deviation|Mean
742178|NCT00491556|Secondary|Difference in CD8 TEMRo CD38 Percentage Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TEMRo CD38 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.||percentage of CD8 TEMRo CD38 cells||Standard Deviation|Mean
742179|NCT00491556|Secondary|Difference in CD8 TEMRo CD38 Percentage Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TEMRo CD38 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.||percentage of CD8 TEMRo CD38 cells||Standard Deviation|Mean
742180|NCT00491556|Secondary|Difference in CD8 TEMRo CD28 Percentage Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TEMRo CD28 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.||percentage of CD8 TEMRo CD28 cells||Standard Deviation|Mean
742181|NCT00491556|Secondary|Difference in CD8 TEMRo CD28 Percentage Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TEMRo CD28 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.||percentage of CD8 TEMRo CD28 cells||Standard Deviation|Mean
742182|NCT00491556|Secondary|Difference in CD8 TCM HLA-DR Percentage Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TCM HLA-DR percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.||percentage of CD8 TCM HLA-DR T cells||Standard Deviation|Mean
742183|NCT00491556|Secondary|Difference in CD8 TCM HLA-DR Percentage Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TCM HLA-DR percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.||percentage of CD8 TCM HLA-DR T cells||Standard Deviation|Mean
742184|NCT00491556|Secondary|Difference in CD8 TCM CD57 Percentage Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TCM CD57 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.||percentage of CD8 TCM CD57 cells||Standard Deviation|Mean
744430|NCT00509392|Primary|Pain|Pain 0-10 scale (10 most severe)|48 Hour|Data available at 48 hr follow-up visit||units on a scale|limbs|Standard Deviation|Mean
742185|NCT00491556|Secondary|Difference in CD8 TCM CD57 Percentage Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TCM CD57 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.||percentage of CD8 TCM CD57 cells||Standard Deviation|Mean
742186|NCT00491556|Secondary|Difference in CD8 TCM CD38 Percentage Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TCM CD38 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.||percentage of CD8 TCM CD38 cells||Standard Deviation|Mean
742187|NCT00491556|Secondary|Difference in CD8 TCM CD38 Percentage Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TCM CD38 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.||percentage of CD8 TCM CD38 cells||Standard Deviation|Mean
742188|NCT00491556|Secondary|Difference in CD8 TCM CD28 Percentage Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TCM CD28 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.||percentage of CD8 TCM CD28 cells||Standard Deviation|Mean
742189|NCT00491556|Secondary|Difference in CD8 TCM CD28 Percentage Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TCM CD28 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.||percentage of CD8 TCM CD28 cells||Standard Deviation|Mean
742190|NCT00491556|Secondary|Difference in CD8 Naïve T-Cell Percentage Expressing HLA-DR Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 Naïve T-Cell percentage Expressing HLA-D, therefore the number of participants analyzed was reduced from 25 to 23 participants.||percentage of CD8 naïve HLA-DR T cells||Standard Deviation|Mean
742191|NCT00491556|Secondary|Difference in CD8 Naïve T-Cell Percentage Expressing Human Leukocyte Antigen-D Related (HLA-DR) Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 Naïve T-Cell percentage Expressing Human Leukocyte Antigen-D related (HLA-DR), therefore the number of participants analyzed was reduced from 25 to 23 participants.||percentage of CD8 naïve HLA-DR T-cells||Standard Deviation|Mean
742192|NCT00491556|Secondary|Difference in CD8 Naïve CD57 Cell Percentage Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 Naïve CD57 Cell percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.||percentage of CD8 naïve CD57 cells||Standard Deviation|Mean
742193|NCT00491556|Secondary|Difference in CD8 Naïve CD57 Cell Percentage Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 Naïve CD57 Cell percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.||percentage of CD8 naïve CD57 cells||Standard Deviation|Mean
742194|NCT00491556|Secondary|Difference in CD8 Naïve CD38 Cell Percentage Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 Naïve CD38 Cell percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.||percentage of CD8 naïve CD38 cells||Standard Deviation|Mean
742195|NCT00491556|Secondary|Difference in CD8 Naïve CD38 Cell Percentage Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 Naïve CD38 Cell percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.||percentage of CD8 naïve CD38 cells||Standard Deviation|Mean
742196|NCT00491556|Secondary|Difference in CD8 Naïve CD28 Cell Percentage Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 Naïve CD28 Cell percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.||percentage of CD8 Naïve CD28 Cells||Standard Deviation|Mean
742197|NCT00491556|Secondary|Difference in CD8 Naïve CD28 Cell Percentage Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 Naïve CD28 Cell percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.||percentage of CD8 naïve CD28 cells||Standard Deviation|Mean
742198|NCT00491556|Secondary|Difference in CD8+ TEMRa Count Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8+ TEMRa count, therefore the number of participants analyzed was reduced from 25 to 23 participants.||CD8+ TEMRa cells/cubic millimeter||Standard Deviation|Mean
742199|NCT00491556|Secondary|Difference in CD8+ TEMRa Count Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8+ TEMRa count, therefore the number of participants analyzed was reduced from 25 to 23 participants.||CD8+ TEMRa cells/cubic millimeter||Standard Deviation|Mean
742200|NCT00491556|Secondary|Difference in CD8+ TEMRo Count Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8+ TEMRo count, therefore the number of participants analyzed was reduced from 25 to 23 participants.||CD8+ TEMRo cells/cubic millimeter||Standard Deviation|Mean
742201|NCT00491556|Secondary|Difference in CD8+ TEMRo Count Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8+ TEMRo count, therefore the number of participants analyzed was reduced from 25 to 23 participants.||CD8+ TEMRo cells/cubic millimeter||Standard Deviation|Mean
742202|NCT00491556|Secondary|Difference in CD8+ TCM Count Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8+ TCM count, therefore the number of participants analyzed was reduced from 25 to 23 participants.||CD8+ TCM cells/cubic millimeter||Standard Deviation|Mean
742203|NCT00491556|Secondary|Difference in CD8+ TCM Count Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8+ TCM count, therefore the number of participants analyzed was reduced from 25 to 23 participants.||CD8+ TCM cells/cubic millimeter||Standard Deviation|Mean
742204|NCT00491556|Secondary|Difference in CD8+ Naïve T-Cell Count Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8+ Naïve T-Cell count, therefore the number of participants analyzed was reduced from 25 to 23 participants.||CD8+ naïve T cells/cubic millimeter||Standard Deviation|Mean
742205|NCT00491556|Secondary|Difference in CD8+ Naïve T-Cell Count Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8+ Naïve T-Cell count, therefore the number of participants analyzed was reduced from 25 to 23 participants.||CD8+ naïve t-cells/cubic millimeter||Standard Deviation|Mean
742206|NCT00491556|Secondary|Difference in CD4+ TEMRa Count Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD4+ TEMRa count, therefore the number of participants analyzed was reduced from 25 to 23 participants.||CD4+ TEMRa cells/cubic millimeter||Standard Deviation|Mean
742207|NCT00491556|Secondary|Difference in CD4+ TEMRa Count Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD4+ TEMRa count, therefore the number of participants analyzed was reduced from 25 to 23 participants.||CD4+ TEMRa cells/cubic millimeter||Standard Deviation|Mean
742208|NCT00491556|Secondary|Difference in CD4+ TEMRo Count Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD4+ TEMRo count, therefore the number of participants analyzed was reduced from 25 to 23 participants.||CD4+ TemRo cells/cubic millimeter||Standard Deviation|Mean
742209|NCT00491556|Secondary|Difference in CD4+ Effector Memory (TEM)Ro Count Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD4+ Effector Memory (TEM)Ro count, therefore the number of participants analyzed was reduced from 25 to 23 participants.||CD4+ TemRo cells/cubic millimeter||Standard Deviation|Mean
742210|NCT00491556|Secondary|Difference in CD4+ TCM Count Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm.Two subjects did not have enough blood samples to measure CD4+ TCM count, therefore the number of participants analyzed was reduced from 25 to 23 participants.||CD4+ TCM cells/cubic millimeter||Standard Deviation|Mean
742211|NCT00491556|Secondary|Difference in CD4+ Termed Central Memory (TCM) Count Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm.Two subjects did not have enough blood samples to measure CD4+ Termed Central Memory (TCM) count, therefore the number of participants analyzed was reduced from 25 to 23 participants.||CD4+ TCM cells/cubic millimeter||Standard Deviation|Mean
742212|NCT00491556|Secondary|Difference in CD4+ Naïve T Cell Count Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm.Two subjects did not have enough blood samples to measure CD4+ Naïve T-Cell count, therefore the number of participants analyzed was reduced from 25 to 23 participants.||CD4+ naïve t-cells/cubic millimeter||Standard Deviation|Mean
742213|NCT00491556|Secondary|Difference in CD4+ Naïve T Cell Count Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm.Two subjects did not have enough blood samples to measure CD4+ Naïve T-Cell count, therefore the number of participants analyzed was reduced from 25 to 23 participants.||CD4+ naïve t-cells/cubic millimeter||Standard Deviation|Mean
742214|NCT00491556|Secondary|Difference in CD4+ T Cell Count Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm||CD4+ T cells/cubic millimeter||Standard Deviation|Mean
742215|NCT00491556|Secondary|Difference in CD4+ T Cell Count Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm.||CD4+ T cells/cubic millimeter||Standard Deviation|Mean
742216|NCT00491556|Primary|Difference in CD4+ T Cell Percentage Between Week 48 and Week 152||152 Weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm||percentage of CD4+ T cells||Standard Deviation|Mean
742217|NCT00491556|Primary|Difference in CD4+ T Cell Percentage Between Week 0 and Week 48||Week 0 and Week 48|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized to the experimental arm.||percentage of CD4+ T cells||Standard Deviation|Mean
742245|NCT00480779|Secondary|Change in Systolic Blood Pressure|A secondary outcome for this study will be change in systolic blood pressure, measured pre and post intervention.|Baseline and 3 months|Intent to treat. Participants with relevant medication changes between baseline and 3 months were excluded.||mmHg||Standard Deviation|Mean
744431|NCT00509496|Secondary|Toxicity|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|6 years|||Participants|||Number
742218|NCT00491608|Secondary|Number of Participants With Clinically Significant Changes in Mean Values for Vital Signs (Temperature, Systolic Blood Pressure, Diastolic Blood Pressure, Respiration Rate, Heart Rate) at Baseline and Day 29|Laboratory findings considered clinically significant by investigator when associated with symptoms, required specific treatment, or required a change in participant management. Clinically significant changes in vital signs were reported as adverse events.|Baseline and Day 29 (end of study)|All participants who received at least 1 application of rThrombin during surgery.||Participants|||Number
742219|NCT00491608|Secondary|Number of Participants With Abnormal Laboratory Results in Median Levels of Immunoglobulin A, G, and M at Baseline or Day 29|Abnormal laboratory findings were recorded as AEs when the investigator considered them to be clinically significant (eg, an unusual result for the surgical population or for an individual participant) or when they were associated with symptoms or required treatment or a change in patient management.|Baseline and Day 29 (end of study)|All participants who received rThrombin and had both baseline and postbaseline antibody assessments available.||Participants|||Number
742220|NCT00491608|Secondary|Number of Participants With Elevations in Coagulation Parameters of CTC Grade 3 or Higher at Baseline and Day 29|Activated partial thromboplastin time (aPTT) elevations: Grade 3=>2*upper limit of normal (ULN). International normalized ratio(INR)elevations: Grade 3=>2*ULN. Changes in prothrombin time were not graded for toxicity. n=Number of participants with assessments available at that visit.|Baseline and Day 29 (end of study)|All participants who received at least 1 application of rThrombin during surgery and had laboratory test results available for assessment.||Participants|||Number
742221|NCT00491608|Secondary|Number of Participants With Abnormal Hematology Laboratory Results of Common Terminology Criteria (CTC) Grade 2 or Higher at Baseline and Day 29|Hemoglobin, low (g/L): Grade 2=<100 Grade 3=<80; Grade 4=<65. Platelets, low: Grade 2=<75*10^9/L; Grade 3=<50*10^9/L; Grade 4=<25*10^9/L. Leukocytes, low: Grade 2=<3.0-2.0*10^9/L; Grade 3=<2.0-1.0*10^9/L; Grade 4=<1.0*10^9/L. Lymphocytes, low: Grade 2=<0.8*10^9/L; Grade 3=<0.5*10^9/L; Grade 4=<0.2*10^9/L. Neutrophils, low: Grade 2=<1.5*10^9/L; Grade 3=<1.0*10^9/L; Grade 4=<0.5*10^9/L. Changes in hematocrit values observed were not graded for severity.|Baseline and Day 29 (end of study)|All participants who who received at least 1 application of rThrombin during surgery and had laboratory test results available for baseline and Day 29 visits.||Participants|||Number
742222|NCT00491608|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events, Treatment-related Adverse Events (AEs), and Treatment-emergent AEs|AE=a new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may or may not have a causal relationship with treatment. SAE=an unfavorable medical event that results in death, persistent or significant incapacity, or drug dependency or abuse; is life-threatening, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=possibly, probably, or certainly related to study drug. Treatment-emergent=onset on or after treatment start. Grade (Gr) 1=mild, Gr 2=moderate, Gr 3=severe, Gr 4=life threatening/disabling, Gr 5=death.|Day 1 (surgery) to Day 29 (end of study), continuously|All participants who received at least 1 application of rThrombin during surgery.||Participants|||Number
742223|NCT00491608|Primary|Number of Participants With Anti-recombinant Thrombin (rThrombin) Product Antibodies at Day 29 in Participants With and Without Anti-bovine Thrombin Product Antibodies at Baseline|Seropositive=with specific anti-bovine thrombin product antibodies; seronegative=without specific anti-bovine thrombin product antibodies.|At Day 29|Participants who received treatment with rThrombin and had results from both baseline and post-baseline antibody assessments||Participants|||Number
742224|NCT00491738|Primary|All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher)|Grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0, laboratory toxicities based on local laboratory assessments.|5 months|||participants|||Number
742225|NCT00491764|Secondary|Treatment Success of Onychomycosis at Week 48|Treatment success was defined as negative mycology (negative culture and negative KOH) and =<10% nail involvement.|Measured at Day 1, Week 2, Week 4, and Every 4 Weeks Thereafter Until Week 48|This analysis was based on all randomized subjects who had a baseline assessment and at least one post-baseline assessment available, and who had been exposed to at least one dose of study medication||Participants|||Number
742226|NCT00491764|Secondary|Effective Treatment of Onychomycosis at Week 48.|Effective treatment is defined as negative mycology (negative culture and KOH) and either 0% nail involvement or >5 mm growth of unaffected nail|Measured at Day 1, Week 2, Week 4, and Every 4 Weeks Thereafter Until Week 48|This analysis was based on all randomized subjects who had a baseline assessment and at least one post-baseline assessment available, and who had been exposed to at least one dose of study medication||Participants|||Number
742227|NCT00491764|Primary|Complete Cure of Onychomycosis at Week 48.|Complete cure is defined as negative mycology (negative culture and KOH [potassium hydroxide]) and 0% nail involvement (defined as absence of onycholysis and subungual hyperkeratosis).|Measured at Day 1, Week 2, Week 4, and Every 4 Weeks Thereafter Until Week 48|This analysis was based on all randomized subjects who had a baseline assessment and at least one post-baseline assessment available, and who had been exposed to at least one dose of study medication||Participants|||Number
742228|NCT00491829|Primary|Change From Baseline in the Frequency of Satisfying Sexual Events as Measured by the eDiary.|To obtain information on satisfying sexual events (SSEs), a small personal handheld electronic device was to be used by the patients to record such information daily (eDiary). An SSE was recorded when a patient answered “yes” to the eDiary question: “Was the event satisfying for you?”|baseline to 24 weeks|Patients who had at least one post-dose on-treatment efficacy assessment were included in the Full Analysis Set (FAS). The FAS was used for primary analyses.||events per month||Standard Deviation|Mean
742229|NCT00491894|Secondary|Investigator's Global Assessment of Treatment|The investigator performed an overall evaluation of glycopyrrolate liquid for the treatment of drooling, benefits, and side effects over the duration of the study. The investigator selected one of the following choices to assess if ‘This is a worthwhile treatment’: 1 = strongly agree, 2 = agree, 3 = neutral, 4 = disagree, 5 = strongly disagree. A dichotomous global assessment was also performed and summarized with the categories ‘responder’ (strongly agree and agree responses aggregated) and ‘non-responder’ (neutral, disagree, and strongly disagree responses aggregated)|Week 24|The analysis for investigator's Global Assessment was done by intention to treat method||Participants|||Number
745616|NCT00517192|Secondary|Response up to 48 Weeks Using VL < 50 Copies/mL Using Censored||up to 48 weeks||||||
748844|NCT00538642|Secondary|Systolic Blood Pressure||4-5 months|||mm Hg||Standard Deviation|Mean
742230|NCT00491894|Secondary|Parent/Caregiver's Global Assessment of Treatment|The parent/caregiver performed an overall evaluation of glycopyrrolate liquid for the treatment of drooling, benefits, and side effects over the duration of the study. The parent/caregiver selected one of the following choices to assess if ‘This is a worthwhile treatment’: 1 = strongly agree, 2 = agree, 3 = neutral, 4 = disagree, 5 = strongly disagree. A dichotomous global assessment was also performed and summarized with the categories ‘responder’ (strongly agree and agree responses aggregated) and ‘non-responder’(neutral, disagree, and strongly disagree responses aggregated)|Week 24|The analysis for parent/caregiver's Global Assessment was done by intention to treat method||Participants|||Number
742231|NCT00491894|Secondary|Parent/Caregiver's Assessment of the Extent of Drooling Using VAS|Parents/caregivers were to complete a 10 cm “Parent/Caregiver’s Assessment of Extent of Drooling for the Day” VAS assessment (0 = normal; 10 = extremely wet) to provide an overall assessment of the extent of drooling for that day.|Week 24|||VAS score||Standard Deviation|Mean
742232|NCT00491894|Secondary|Parent/Caregiver's Assessment of the Extent of Drooling Using Visual Analog Scale (VAS)|Parents/caregivers were to complete a 10 cm “Parent/Caregiver’s Assessment of Extent of Drooling for the Day” VAS assessment (0 = normal; 10 = extremely wet) to provide an overall assessment of the extent of drooling for that day.|Baseline|||VAS score||Standard Deviation|Mean
742233|NCT00491894|Primary|Proportion of Responders According to the Modified Teacher’s Drooling Scale (mTDS)|The primary efficacy variable was patient's response status using the change from baseline to Week 24 evaluations of the mTDS assessment. Each patient was classified as a responder or non-responder according to the change in their mean mTDS rating from baseline to Week 24. Responders were patients who had at least a 3-point decrease in mTDS rating from baseline|6 months|The analysis was done by intention to treat method. For purposes of statistical estimation, patients who dropped out due to lack of efficacy had their worst observation carried forward. Patients who dropped out for reasons other than lack of efficacy had their last observation carried forward||Participants|||Number
742234|NCT00480532|Secondary|Subject Compliance|measured by self report of pill intake on daily diary (yes/no), and reported as percentage with no missed pills over entire study|Assessed on day 112 of the study (the end of the study period). The outcome reflects the number of subjects who did not miss pills during the entire 112 day study. It does not represent a change from baseline.|||number of participants with no missed pi|||Number
742235|NCT00480532|Secondary|Subject Satisfaction.|"measured using 100 mm visual analog scale. anchors of not at all satisfied (0mm) extremely satisfied (100mm)"|Assessed on day 112 of the study (the end of the study period). This outcome does not represent a change from baseline. It was assessed at the end of the study period.|||mm||Standard Deviation|Mean
742236|NCT00480532|Primary|Differences in Bleeding Patterns Between Study Groups.|number of days of bleeding and spotting, self reported on calendar|The outcome was also assessed for day 1 to 84|All participants analyzed in the groups to which they were randomized except for 1 subject in prevention placebo group who was erroneously enrolled although she did not meet enrollment entry criteria||days||Standard Error|Mean
742237|NCT00480636|Secondary|Number of Participants With Recurrent DVT|Defined as the number of participants with recurrence of DVT (diagnosed using compressive ultrasound examination or autopsy) after it has resolved (at the same location) or occurrence of new DVT at a new location on any of the post-baseline visits|Month 6 or EOT (up to Month 6)|FAS||Participants|||Number
742238|NCT00480636|Secondary|Percent of Participants With and Without Pulmonary Embolism (PE)|PE (diagnosed on the basis of ventilation-perfusion scan of the lungs or autopsy)|Baseline, Week 2, Month 1, Month 3, and Month 6 or EOT (up to Month 6)|FAS. n = number of participants per PE status at observation.||Percent of participants|||Number
742239|NCT00480636|Secondary|Number of Participants With Severe Bleeding That Resulted in a Decrease in Hemoglobin Level of at Least 2.0 Grams Per Deciliter (g/dL)|Episodes of the severe bleeding (intracranial, intraspinal, intraocular, retroperitoneal, or in pericardial area) or bleeding from GIT, urinary system or gynecological bleeding which led to a drop of hemoglobin of at least 2.0 g/dL. Subjects were assessed for severe bleeding as part of a systematic adverse event assessment.|Baseline through Month 6 or EOT (up to Month 6)|Safety analysis set.||Participants|||Number
742240|NCT00480636|Secondary|Number of Participants With Severe Bleeding That Resulted in a Transfusion of at Least 2 Units of Blood|Episodes of the severe bleeding (intracranial, intraspinal, intraocular, retroperitoneal, or in pericardial area) or bleeding from gastrointestinal (GIT), urinary system or gynecological bleeding resulted in a need for a transfusion of at least 2 units of blood. Subjects were assessed for severe bleeding as part of a systematic adverse event assessment.|Baseline through Month 6 or EOT (up to Month 6)|The safety analysis set was defined as all participants who received at least 1 dose of study treatment.||Participants|||Number
742241|NCT00480636|Primary|Number of Participants With Resolution of Deep Vein Thrombosis (DVT) of the Leg|Resolution criteria: clinical cure, defined as negative results of a compressive ultrasound examination of the leg|Month 6 or End of Treatment (EOT) (up to Month 6)|Full analysis set (FAS): all participants who received at least 1 dose of the study treatment and who had at least 1 post baseline efficacy measurement.||Participants|||Number
742242|NCT00480740|Primary|Changes in Hemodynamic Variables Recorded During Administration of Sevoflurane + Dexmedetomidine.|"Non-inferiority was shown when differences at steady-state (dexmedetomidine + sevoflurane) compared to baseline (sevoflurane alone) and its associated 95% confidence interval fell completely within the range of plus or minus 20%.The 95% confidence interval was normalized by subtracting the baseline values.
Bispectral Index: monitors electroencephalographic and electromyographic parameters to monitor the depth of anesthesia."|Up to 24 hours following cardiac catheterization|||percentage of change from baseline||95% Confidence Interval|Mean
742243|NCT00480779|Secondary|Change in Triglycerides|A secondary outcome for this study will be change in Triglyceride level, measured pre and post intervention.|Baseline and 3 months|Intent to treat. Participants with relevant medication changes between baseline and 3 months were excluded.||mg/dl||Inter-Quartile Range|Median
742244|NCT00480779|Secondary|Change in Diastolic Blood Pressure|A secondary outcome for this study will be change in diastolic blood pressure, measured pre and post intervention.|Baseline and 3 months|Intent to treat. Participants with relevant medication changes between baseline and 3 months were excluded.||mmHg||Standard Deviation|Mean
743542|NCT00486278|Secondary|Biochemistry: ALAT (Alanine Aminotransferase)||screening visit, pre-dose and 12 hours after dosing|Safety analysis set includes all subjects who received at least one dose of the investigational product.||U/L||Standard Deviation|Mean
742246|NCT00480779|Secondary|Change in Hemoglobin A1C|A secondary outcome for this study will be change in HbA1c, measured pre and post intervention. The hemoglobin HbA1c test provides information regarding how well blood glucose (sugar) has been controlled for the previous 8-12 weeks..|Baseline and 3 months|Intent to treat. Participants with relevant medication changes between baseline and 3 months were excluded.||percentage of glycosylated hemoglobin||Standard Deviation|Mean
742247|NCT00480779|Secondary|Change in Fasting Glucose|A secondary outcome for this study will be change in fasting glucose, measured pre and post intervention.|Baseline and 3 months|Intent to treat. Participants with relevant medication changes between baseline and 3 months were excluded.||mg/dl||Standard Deviation|Mean
742248|NCT00480779|Secondary|Change in LDL Cholesterol|A secondary outcome for this study will be change in LDL cholesterol, measured pre and post intervention.|Baseline and 3 months|Intent to treat. Participants with relevant medication changes between baseline and 3 months were excluded.||mg/dl||Standard Deviation|Mean
742249|NCT00480779|Secondary|Change in HDL Cholesterol|A secondary outcome for this study will be change in HDL cholesterol, measured pre and post intervention.|Baseline and 3 months|Intent to treat. Participants with relevant medication changes between baseline and 3 months were excluded.||mg/dl||Standard Deviation|Mean
742250|NCT00480779|Secondary|Change in Total Cholesterol|A secondary outcome for this study will be change in total cholesterol, measured pre and post intervention.|Baseline and 3 months|Intent to treat. Participants with relevant medication changes between baseline and 3 months were excluded.||mg/dl||Standard Deviation|Mean
742251|NCT00480779|Secondary|Change in Waist Circumference|A secondary outcome for this study will be change in waist circumference, measured pre and post intervention.|Baseline and 3 months|Intent to treat||inches||Standard Deviation|Mean
742252|NCT00480779|Primary|Change in Weight|The primary outcome for this study will be change in weight measured pre and post intervention.|Baseline and 3 months|Intent to treat using Last Observation Carried Forward (LOCF)||pounds||Standard Deviation|Mean
742253|NCT00492024|Other Pre-specified|Percentage of Subjects With Clinical Cure (Per Protocol Population (PP))|The primary efficacy variable was clinical response (CR) at the TOC visit, and was rated as improvement, complete resolution, failure, or indeterminate. Clinical cure, ie, success, was defined as complete resolution or improvement in the signs and symptoms such that no further therapy (antimicrobial, steroid, or irrigation) was required.|At 'Test-of-Cure', Day 1-5 after end of treatment|This analysis population was per protocol population, which included all subjects with at least one pre-treatment causative organism, and who had no major deviations from the protocol procedures.||Percentage of subjects|||Number
742254|NCT00492024|Secondary|Percentage of Subjects With Continued Clinical Cure During Long-Term Follow-Up|A secondary efficacy variable was clinical response (CR) at the Follow-up visit 17-21 days following the start of treatment. CR was rated as continued cure, failure/relapse, or indeterminate. Clinical evaluation was based on the presence and severity (mild, moderate, or severe) of several signs and symptoms of acute sinusitis.|Day 12 to 26 after end of treatment|The MITT population was the primary analysis population. This population includes all subjects treated with at least one dose of study medication, and who have at least one pre-treatment causative organism.||Percentage of subjects|||Number
742255|NCT00492024|Secondary|Percentage of Subjects With Clinical Improvement During Therapy|A secondary efficacy variable was clinical response (CR) at the During Therapy visit at day 3 or 4 of treatment. CR was rated as improvement, cure, failure, or indeterminate. Clinical evaluation was based on the presence and severity (mild, moderate, or severe) of several signs and symptoms of acute sinusitis.|Day 3 of treatment|The MITT population was the primary analysis population. This population includes all subjects treated with at least one dose of study medication, and who have at least one pre-treatment causative organism. Missing responses at during therapy visit in most cases was due to early clinical failure.||Percentage of subjects|||Number
742256|NCT00492024|Secondary|Treatment Day When Patients Returned to Normal Activities as Measured by Patient Reported Data, Using LOCF Approach|The Activity Impairment Assessment (AIA) questionnaire was used to assess activity impairment at baseline and time to return to normal activities. The AIA was administered prior to first dose, every 24 hours during treatment, and at the TOC visit. Improvement in the AIA total score was defined as a decrease of at least 3 units.|Daily until 'Test-Of-Cure' (Day 1-5 after end of treatment)|The MITT population was the primary analysis population. This population includes all subjects treated with at least one dose of study medication, and who have at least one pre-treatment causative organism.||participants|||Number
742257|NCT00492024|Secondary|Treatment Day When Patients Reached Symptom Improvement as Measured by Patient Reported Data, Using Last Observation Carried Forward (LOCF) Approach|The Sino-Nasal Outcome Test (SNOT-16) was used to assess subject-reported time to symptom improvement. Improvement was defined as a decrease of at least 14 units on the test. This difference is the smallest difference that has been identified as beneficial to subjects.|Daily until 'Test-Of-Cure' (Day 1-5 after end of treatment)|The MITT population was the primary analysis population. This population includes all subjects treated with at least one dose of study medication, and who have at least one pre-treatment causative organism.||participants|||Number
742258|NCT00492024|Primary|Percentage of Subjects With Clinical Cure (Modified Intent-to-Treat (MITT))|The primary efficacy variable was clinical response (CR) at the TOC visit, and was rated as improvement, complete resolution, failure, or indeterminate. Clinical cure, ie, success, was defined as complete resolution or improvement in the signs and symptoms such that no further therapy (antimicrobial, steroid, or irrigation) was required.|At 'Test-of-Cure' (TOC), Day 1-5 after end of treatment|The modified intent-to-treat (MITT) population was the primary analysis population. This population includes all subjects treated with at least one dose of study medication, and who have at least one pre-treatment causative organism.||Percentage of subjects|||Number
742259|NCT00492063|Secondary|Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination|The solicited local and systemic reactions were collected from day 1 up to and including day 7 after vaccination for both the vaccine groups.|Up to 7 days postvaccination|Analysis was done on Safety population i.e., all subjects with vaccination and with some post-baseline safety data.||Number of Subjects|||Number
742285|NCT00492973|Primary|Knee Society Scores|The Knee Society Score is on a scale of 0 to 100, with 0 being the worst possible score, and 100 being the best possible score. The Knee Society Score takes into account subjective patient reports of pain and functional ability as well as clinical measures of passive knee range of motion.|3 months postoperative|||units on a scale||Standard Deviation|Mean
742260|NCT00492063|Primary|Geometric Mean Ratio of Subjects After One Vaccination of cTIV or TIV|Immunogenicity was measured as the geometric mean ratio (GMR), calculated as the ratio of postvaccination to prevaccination HI Geometric Mean Titers (GMTs), three weeks after (day 22) one vaccination of cTIV or TIV. In compliance with the requirements of the EMEA recommendations (CPMP/BWP/2490/00, CPMP/BWP/214/96), this criterion is met if the GMR (day 22/day 1) in HI antibody titer is >2.5 in the ≥18 to ≤60 years of age group or >2.0 in the ≥61 years of age group.|Three weeks after vaccination (day 22)|Analysis was performed on the PP set.||Ratio||95% Confidence Interval|Number
742261|NCT00492063|Primary|Percentages Of Subjects Who Achieved Seroconversion Or Significant Increase In HI Titer After One Vaccination of cTIV or TIV|Seroconversion or significant in HI titer is defined as the percentage of subjects with a prevaccination HI titer <10 (negative) to a postvaccination titer ≥40; or in subjects with prevaccination HI titer ≥10, at least a 4-fold increase in postvaccination HI titer. In compliance with the requirements of the EMEA recommendations (CPMP/BWP/2490/00, CPMP/BWP/214/96), the criterion is met if the percentage of subjects achieving seroconversion/significant increase is >40% in the ≥18 to ≤60 years of age group or >30% in the ≥61 years of age group.|Three weeks after vaccination (day 22)|Analysis was performed on the PP set.||Percentages||95% Confidence Interval|Number
742262|NCT00492063|Primary|Percentages Of Subjects Who Achieved HI Titer ≥40 After One Vaccination of Cell Culture-derived (cTIV) or Egg-derived (TIV) Influenza Subunit Vaccines|"Immunogenicity was measured as the percentage of adults (≥18 to ≤60 years) and elderly (≥61 years) achieving HI titers ≥40 at baseline (day 1) and three weeks (day 22) after one vaccination of cTIV or TIV vaccine for each of three vaccine strains, evaluated using the hemagglutination inhibition (HI) egg-derived antigen assay.
In compliance with the requirements of the EMEA recommendations (CPMP/BWP/2490/00, CPMP/BWP/214/96), this criterion is met if the percentage of subjects achieving HI titers ≥40 is >70% in the ≥18 to ≤60 years of age group or >60% in the ≥61 years of age group."|Before vaccination (day 1) and three weeks after vaccination (day 22)|Analysis was done on the per-protocol (PP) set, i.e. the subjects who received the vaccination correctly; provided evaluable data before and after vaccination; and with no major protocol violations, as defined before unblinding.||Percentages||95% Confidence Interval|Number
742263|NCT00492089|Primary|Number of Participants With Response ( > 25% Reduction in T2 Flair) From Baseline to Evaluation at 6 Weeks Post Treatment|Change in magnetic resonance imaging (MRI) from baseline to evaluation at 6 weeks for participants where MRI changes are based on the size of edema (T2 FLAIR) and Gd-contrast enhancement (lesion diameter and perfusion/dynamic). A 25% reduction in T2 flair volume constitutes a response for study.|Baseline to 12 weeks|Analysis was conducted per protocol. The participants in the Crossover Arm were evaluated after receiving the Bevacizumab treatment as described in the arm description.||participants|||Number
742264|NCT00492206|Secondary|EGFR (Epidermal Growth Factor Receptor) Gene Mutation and Akt, pAkt, and MAPKinase|EGFR (epidermal growth factor receptor) gene mutation status and Akt, pAkt, and MAPKinase in participant tumor tissue.|approx. 5 years|Participants with baseline tumor tissue available for EGFR status analysis by fluorescence in situ hybridization (FISH). Akt, pAkt, and MAPKinase analyses were not conducted.||percentage of tumors|baseline tumor tissue||Number
742265|NCT00492206|Secondary|Best Overall Response Rate (ORR) (Number of Participants)|The Best Overall Response is the best response (Complete Response, Partial Response, Stable Disease, Progressive Disease) recorded from the start of the study treatment until the disease progression/recurrence at end of study. Response and progression were evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000]. Complete Response (CR) is the Disappearance of all target lesions and Partial Response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|Up to 12 weeks after treatment initiation|Patients who received concurrent radiotherapy + cetuximab + consolidation therapy, and patients who did not receive cetuximab||participants|||Number
742266|NCT00492206|Secondary|Progression-free Survival (PFS)|Response and progression were evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000]. Progressive Disease was defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Up to 36 months|Patients with surgically unresectable stage IIIA or IIIB NSCLC. Survival analysis excluded the two ineligible patients with advanced NSCLC.||months||95% Confidence Interval|Median
742267|NCT00492206|Primary|Overall Survival (OS)||Up to 36 months|Patients with surgically unresectable stage IIIA or IIIB NSCLC. Survival analysis excluded the two ineligible patients with advanced NSCLC (N = 38).||months||95% Confidence Interval|Median
742268|NCT00492232|Secondary|Participants Who Achieved a 50% Reduction in Zolpidem Dosage at Any Time During the Double-Blind Treatment Period|Participants who achieved a 50% reduction in zolpidem dosage at any previously defined 2-week period (ie, reduction phase) during the DBTP were summarized. The reduction in dosage at any time=[1-(reduction phase weekly dosage/baseline weekly dosage)]*100%.|Baseline and Weeks 1-10|Analysis was performed on all subjects who were randomized and received at least 1 dose of double-blind medication during the study. Subjects were analyzed by the treatment they were randomized to receive.||participants|||Number
742269|NCT00492232|Secondary|Participants Who Achieved a 50% Reduction in Zolpidem Dosage at the End of the Double-Blind Treatment Period|Participants who achieved a 50% reduction in zolpidem dosage (or frequency) at the end of the DBTP (ie, the end of Reduction Phase 4) were summarized. The reduction in dosage at Reduction Phase 4=[1-(Reduction Phase 4 weekly dosage/baseline weekly dosage)]*100%.|Baseline and Week 10|Analysis was performed on all randomized subjects who took at least 1 dose of study drug, who had completed the DBTP, and who had sufficient zolpidem dosage data in the last 7 days of the DBTP.||participants|||Number
742270|NCT00492232|Secondary|Participants Who Completely Discontinued Zolpidem at the End of Double-Blind Treatment Period, by Method of Discontinuation|Participants who took no zolpidem during the last 7 days of the DBTP were completely discontinued from zolpidem. Participants who completely discontinued zolpidem via reduction in zolpidem use frequency (alone) were not summarized.|Weeks 1-10|Analysis was performed on all randomized subjects who took at least 1 dose of study drug, had completed the DBTP, and had sufficient zolpidem dosage data in the last 7 days of the DBTP. Estimates could not be reported with correct statistical inference due to small sample sizes by method of discontinuation (ie, most subjects reduced zolpidem dose).||participants|||Number
742286|NCT00492973|Primary|Knee Range of Motion||3 months|||degrees||Standard Deviation|Mean
742271|NCT00492232|Secondary|Change From Baseline in Weekly Zolpidem Frequency During Weeks 9-10|The number of nights zolpidem was taken was recorded during Weeks 9-10 of the DBTP. Weekly frequency was calculated as the number of nights zolpidem was taken divided by the number of days within the period, multiplied by 7. Differences in frequency from baseline were summarized.|Baseline and Weeks 9-10|Analysis was performed on all randomized subjects who took at least 1 dose of study drug, who had completed the DBTP, and who had sufficient zolpidem dosage data in the last 7 days of the DBTP.||nights per week||Standard Error|Least Squares Mean
742272|NCT00492232|Secondary|Change From Baseline in Weekly Zolpidem Frequency During Weeks 7-8|The number of nights zolpidem was taken was recorded during Weeks 7-8 of the DBTP. Weekly frequency was calculated as the number of nights zolpidem was taken divided by the number of days within the period, multiplied by 7. Differences in frequency from baseline were summarized.|Baseline and Weeks 7-8|Analysis was performed on all randomized subjects who took at least 1 dose of study drug, who had completed the DBTP, and who had sufficient zolpidem dosage data in the last 7 days of the DBTP.||nights per week||Standard Error|Least Squares Mean
742273|NCT00492232|Secondary|Change From Baseline in Weekly Zolpidem Frequency During Weeks 5-6|The number of nights zolpidem was taken was recorded during Weeks 5-6 of the DBTP. Weekly frequency was calculated as the number of nights zolpidem was taken divided by the number of days within the period, multiplied by 7. Differences in frequency from baseline were summarized.|Weeks 5-6|Analysis was performed on all randomized subjects who took at least 1 dose of study drug, who had completed the DBTP, and who had sufficient zolpidem dosage data in the last 7 days of the DBTP.||nights per week||Standard Error|Least Squares Mean
742274|NCT00492232|Secondary|Change From Baseline in Weekly Zolpidem Frequency During Weeks 3-4|The number of nights zolpidem was taken was recorded during Weeks 3-4 of the DBTP. Weekly frequency was calculated as the number of nights zolpidem was taken divided by the number of days within the period, multiplied by 7. Differences in frequency from baseline were summarized.|Weeks 3-4|Analysis was performed on all randomized subjects who took at least 1 dose of study drug, who had completed the DBTP, and who had sufficient zolpidem dosage data in the last 7 days of the DBTP.||nights per week||Standard Error|Least Squares Mean
742275|NCT00492232|Secondary|Change From Baseline in Weekly Zolpidem Frequency During Weeks 1-2|The number of nights zolpidem was taken was recorded during Weeks 1-2 of the DBTP. Weekly frequency was calculated as the number of nights zolpidem was taken divided by the number of days within the period, multiplied by 7. Differences in frequency from BL were summarized.|Baseline and Weeks 1-2|Analysis was performed on all randomized subjects who took at least 1 dose of study drug, who had completed the DBTP, and who had sufficient zolpidem dosage data in the last 7 days of the DBTP.||nights per week||Standard Error|Least Squares Mean
742276|NCT00492232|Secondary|Change From Baseline in Weekly Zolpidem Dosage During Weeks 9-10|Dosages of zolpidem taken were recorded during Weeks 9-10 of the DBTP. Differences in dosages from baseline were summarized. Weekly dosage was calculated as total amount of zolpidem taken divided by the number of days within the phase, multiplied by 7.|Baseline and Weeks 9-10|Analysis was performed on all randomized subjects who took at least 1 dose of study drug, who had completed the DBTP, and who had sufficient zolpidem dosage data in the last 7 days of the DBTP.||Dose (mg)||Standard Error|Least Squares Mean
742277|NCT00492232|Secondary|Change From Baseline in Weekly Zolpidem Dosage During Weeks 7-8|Dosages of zolpidem taken were recorded during Weeks 7-8 of the double blind period. Differences in dosages from baseline were summarized.|Baseline and Weeks 7-8|Analysis was performed on all randomized subjects who took at least 1 dose of study drug, who had completed the DBTP, and who had sufficient zolpidem dosage data in the last 7 days of the DBTP.||Dose (mg)||Standard Error|Least Squares Mean
742278|NCT00492232|Secondary|Change From Baseline in Weekly Zolpidem Dosage During Weeks 5-6|Dosages of zolpidem taken were recorded during Weeks 5-6 of the DBTP. Differences in dosages from baseline were summarized. Weekly dosage was calculated as total amount of zolpidem taken divided by the number of days within the phase, multiplied by 7.|Baseline and Weeks 5-6|Analysis was performed on all randomized subjects who took at least 1 dose of study drug, who had completed the DBTP, and who had sufficient zolpidem dosage data in the last 7 days of the DBTP.||Dose (mg)||Standard Error|Least Squares Mean
742279|NCT00492232|Secondary|Change From Baseline in Weekly Zolpidem Dosage During Weeks 3-4|Dosages of zolpidem taken were recorded during Weeks 3-4 of the DBTP. Differences in dosages from baseline were summarized. Weekly dosage was calculated as total amount of zolpidem taken divided by the number of days within the phase, multiplied by 7.|Baseline and Weeks 3-4|Analysis was performed on all randomized subjects who took at least 1 dose of study drug, who had completed the DBTP, and who had sufficient zolpidem dosage data in the last 7 days of the DBTP.||Dose (mg)||Standard Error|Least Squares Mean
742280|NCT00492232|Secondary|Change From Baseline in Weekly Zolpidem Dosage During Weeks 1-2|Dosages of zolpidem taken were recorded during Weeks 1-2 of the DBTP. Differences in dosages from baseline were summarized. Weekly dosage was calculated as total amount of zolpidem taken divided by the number of days within the phase, multiplied by 7.|Baseline and Weeks 1-2|Analysis was performed on all randomized subjects who took at least 1 dose of study drug, who had completed the DBTP, and who had sufficient zolpidem dosage data in the last 7 days of the DBTP.||Dose (mg)||Standard Error|Least Squares Mean
742281|NCT00492232|Primary|Percentage of Participants Who Discontinued Zolpidem Therapy|Participants reduced zolpidem incrementally from Week 3 to Week 10 of the double-blind treatment period (DBTP). A participant who did not take any zolpidem during the last 7 days of the DBTP was defined as having completely discontinued zolpidem by that time point. The number of subjects who discontinued zolpidem at the end of the DBTP was summarized.|Week 10|Analysis was performed on all randomized subjects who took at least 1 dose of study drug, who had completed the DBTP, and who had sufficient zolpidem dosage data in the last 7 days of the DBTP.||Percentage of participants|||Number
742282|NCT00492973|Primary|Complications, Such as Infections, Hospital Readmissions, Manipulations Under Anesthesia, Etc.||any point during the first postoperative year|||Number of participants with complication|||Number
742283|NCT00492973|Primary|Patient Satisfaction||6 weeks, 3 months, and 1 year postoperative||||||
742284|NCT00492973|Primary|Amount of Pain Medication Taken Per Day||Average of 3 days after surgery|||mg/day morphine equivalant||Standard Deviation|Mean
742287|NCT00492973|Primary|Length of Hospital Stay||days after surgery|||days||Standard Deviation|Mean
742288|NCT00493012|Secondary|Change in Hb A1c From Baseline to 12 Months||change from baseline to 12 months|||% glycosylated hemoglobin||Standard Deviation|Mean
742299|NCT00493038|Secondary|Number of Participants With Response (Microbiologically Valid Patients)|Bacteriological Efficacy Rate at the End of Follow-up period, measured in patients defined as 'microbiologically valid'. A bacteriological success is an eradication without super- or reinfection or presumed eradication.|End of Follow-up, Day 24-30 after treatment|Patients valid per protocol with a causative organism cultured.||Participants|||Number
742300|NCT00493038|Secondary|Number of Participants With Response (Microbiologically Valid Patients)|Bacteriological Efficacy Rate at the 'Test-of-Cure' visit, measured in patients defined as 'microbiologically valid'. A bacteriological success is an eradication without super- or reinfection or presumed eradication.|At 'Test-of-Cure', Day 1-3 after treatment|Patients valid per protocol with a causative organism cultured.||Participants|||Number
742301|NCT00493038|Secondary|Number of Participants With Response (Per-protocol Population)|Number of patients in the population who met criteria pre-specified in the protocol whose clinical response 24-30 days after treatment was assessed by the investigator as “continued clinical cure”|End of Follow-up, Day 24-30 after treatment|PP population at end FU: (1) Clinical evaluation was performed at the TOC visit (2) No other systemic antibacterial agent was administered with study drug up to the TOC visit (3) Adequate treatment compliance (≥80% of study drug taken) (4) Random code not broken (5) No protocol violation affecting treatment efficacy (6) FU assessment available||participants|||Number
742302|NCT00493038|Secondary|Number of Participants With Response (Intent-to-treat Population)|Number of patients in the population who received at least one dose of study medication whose clinical response 1-3 days after treatment was assessed by the investigator as “clinical cure”|At 'Test-of-Cure', Day 1-3 after treatment|ITT population: participants having at least one observation under study medication||participants|||Number
742303|NCT00493038|Primary|Number of Participants With Response (Per-protocol Population)|Number of patients in the population who met criteria pre-specified in the protocol whose clinical response 1-3 days after treatment was assessed by the investigator as “clinical cure”|At 'Test-of-Cure', Day 1-3 after treatment|Per Protocol population: subjects to meet all of the following (1) Clinical evaluation was performed at TOC visit (2) No other systemic antibacterial agent was administered with study drug up to TOC visit (3) Adequate treatment compliance (≥ 80% of study drug taken) (4) Random code not broken (5) No protocol violation affecting treatment efficacy||participants|||Number
742304|NCT00493181|Primary|Number of Participants With Complete Response|Number of participants with platelet response of 'Complete Response' (CR) defined as a sustained (>/= 3 months) platelet count >/= 60 x 10^9/L while continuing tyrosine kinase inhibitor (TKI) therapy or sustained (>/= 3 months) re-escalation of TKI dose to the pre-thrombocytopenia level without recurrence of thrombocytopenia.|Weekly platelet count till stabilized with on-going review while receiving treatment (study total 2 years)|||Participants|||Number
742305|NCT00493220|Primary|AUC0-inf|Area under the drug concentration-time curve from time zero to infinity, calculated as AUC0-t + Ct/kel (Ct = time of last measurable concentration; kel = terminal elimination rate constant)|from the start of ceftriaxone administration to infinity|Per protocol (excludes one participant that did not receive intravenous ceftriaxone intervention)||µg*hr/mL||Standard Deviation|Mean
742306|NCT00493220|Primary|AUC0-t|Area under the drug concentration-time curve from time zero to the time of the last measurable concentration (calculated by the linear trapezoidal method)|Start of ceftriaxone administration through time of last measureable plasma ceftriaxone concentration|Per protocol (excludes one participant that did not receive intravenous ceftriaxone intervention)||μg*hr/mL||Standard Deviation|Mean
742307|NCT00493220|Secondary|Tmax|Time to maximum measured plasma ceftriaxone concentration|from start of ceftriaxone administration until time of maximum measured plasma ceftriaxone concentration|Per protocol (excludes one participant that did not receive intravenous ceftriaxone intervention)||hr||Full Range|Median
742308|NCT00493220|Secondary|Cmax|Maximum measured plasma ceftriaxone concentration|at the time of the highest measured plasma ceftriaxone concentration|Per protocol (excludes one participant that did not receive intravenous ceftriaxone intervention)||µg/mL||Standard Deviation|Mean
742309|NCT00493246|Secondary|Subjects Who Experience at Least One Serious Treatment-Emergent Adverse Event (TEAE)|A Serious Treatment Emergent Adverse Event is defined as any untoward medical occurrence at any dose of IV acetaminophen that; Results in Death, Is life-threatening, Requires inpatient hospitalization or causes prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Is a congenital anomaly/birth defect, Is an important medical event|First dose to 30 days following last dose of study medication|All analyses of safety were conducted on the Safety population, which included those subjects who received any portion of a dose of IV acetaminophen.||Participants|||Number
742310|NCT00493246|Secondary|Number of Subjects Reporting at Least One Treatment-Emergent Adverse Event (TEAE)|A TEAE is defined as an adverse event that starts on or after the start of study medication|First dose of study medication to 30 days after the last dose of study medication|||Participants|||Number
742311|NCT00493246|Primary|Multiple-dose Terminal Elimination Half-life [t1/2(h)] Pharmacokinetics of IV Acetaminophen|t1/2: Terminal elimination half-life|48hrs|"Subjects who received at least one dose of IV acetaminophen and had at least 3 PK sampling assessments were included in the PK analysis.This outcome measure represents PK parameters for the last dose of IV acetaminophen.
Due to only one subject in the Neonate 15mg/kg group, t1/2 (h) was not calculated."||Hours||Full Range|Median
742312|NCT00493246|Primary|Multiple-dose Area Und the Curve (AUC) From Time 0 (Predose) to the Time of the Dosing Interval at Steady-state (0-t (µg*h/ml) Pharmacokinetics of IV Acetaminophen|AUC 0-t (µg*h/ml): Area under the plasma concentration versus time curve from time 0 (predose) to the time of the dosing interval at steady-state.|Time Zero (just prior to first dose) to 48 hours post first dose|||µg*h/ml||Full Range|Median
742313|NCT00493246|Primary|Single-dose Time to Reach Maximum Plasma Concentration [Tmax(h)] Pharmacokinetics of IV Acetaminophen|Tmax: Time to reach maximum plasma concentration (Cmax)|Time Zero (just prior to first dose) to 24 hours post first dose|Subjects who received at least one dose of IV acetaminophen and had at least 3 PK sampling assessments were included in the PK analysis.This outcome measure represents PK parameters for the first dose of IV acetaminophen.||Hour||Full Range|Median
742431|NCT00494494|Primary|Post-operative Best Corrected Visual Acuity (BCVA)|The patients were again instructed to read letters on the ETDRS chart 8 weeks post-surgery. The mean and standard deviation for each group was recorded. Letters range from 0 (20/2000) to 110 (20/12.5), with the higher number signaling better visual acuity.|baseline and 8 weeks|||letters||95% Confidence Interval|Mean
742314|NCT00493246|Primary|Single-dose Maximum Plasma Concentration (Cmax) , Micrograms Per Milliliter (µg/mL) Pharmacokinetics of IV Acetaminophen|Cmax: Maximum Plasma Concentration|Time Zero (just prior to first dose) to 24 hours post first dose|Subjects who received at least one dose of IV acetaminophen and had at least 3 PK sampling assessments were included in the PK analysis.This outcome measure represents PK parameters for the first dose of IV acetaminophen.||micrograms per milliliter (µg/mL)||Full Range|Median
742315|NCT00493285|Secondary|Number of Participants With Seroresponse to PIV3 28 Days After Dose 3|Seroresponse is equal to or greater than a 4-fold rise in PIV3 antibody from baseline as measured by HAI assay.|Days 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for PIV3. Hemagglutination inhibition antibody results obtained on or after detection of wild-type HPIV3 in culture were not considered valid.||participants|||Number
742316|NCT00493285|Secondary|Number of Participants With Seroresponse to PIV3 28 Days After Dose 2|Seroresponse is equal to or greater than a 4-fold rise in PIV3 antibody from baseline as measured by HAI assay.|Days 28-34 after Dose 2 (Dose 2 was on Day 48-64)|The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for PIV3. Hemagglutination inhibition antibody results obtained on or after detection of wild-type HPIV3 in culture were not considered valid.||participants|||Number
742317|NCT00493285|Secondary|Number of Participants With Seroresponse to PIV3 28 Days After Dose 1|Seroresponse is equal to or greater than a 4-fold rise in PIV3 antibody from baseline as measured by HAI assay.|Days 28-34 after Dose 1 (Dose 1 was on Day 0)|The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for PIV3. Hemagglutination inhibition antibody results obtained on or after detection of wild-type HPIV3 in culture were not considered valid.||participants|||Number
742318|NCT00493285|Secondary|Number of Participants With Seroresponse to RSV 28 Days After Dose 3|Seroresponse is equal to or greater than a 4-fold rise in RSV antibody from baseline as measured by microneutralization assay.|Days 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for RSV.||participants|||Number
742319|NCT00493285|Secondary|Number of Participants With Seroresponse to RSV 28 Days After Dose 2|Seroresponse is equal to or greater than a 4-fold rise in RSV antibody from baseline as measured by microneutralization assay.|Days 28-34 after Dose 2 (Dose 2 was on Day 48-64)|The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for RSV.||participants|||Number
742320|NCT00493285|Secondary|Number of Participants With Seroresponse to RSV 28 Days After Dose 1|Seroresponse is equal to or greater than a 4-fold rise in RSV antibody from baseline as measured by microneutralization assay.|Days 28-34 after Dose 1 (Dose 1 was on Day 0)|The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for RSV.||participants|||Number
742321|NCT00493285|Secondary|Geometric Mean Titers (GMTs) of Serum HAI Antibodies to PIV3 Day 28 Post Dose 3|Post dose GMT of serum antibody response to PIV3 as measured by HAI assay. Limit of quantification is 4. For results reported as < 4, a value of 2 was imputed.|Day 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for PIV3 and/or RSV.||GMT||95% Confidence Interval|Mean
742322|NCT00493285|Secondary|Geometric Mean Titers (GMTs) of Serum HAI Antibodies to PIV3 Day 28 Post Dose 2|Post dose GMT of serum antibody response to PIV3 as measured by HAI assay. Limit of quantification is 4. For results reported as < 4, a value of 2 was imputed.|Day 28-34 after Dose 2 (Dose 2 was on Day 48-64)|The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for PIV3 and/or RSV.||GMT||95% Confidence Interval|Mean
742323|NCT00493285|Secondary|Geometric Mean Titers (GMTs) of Serum HAI Antibodies to PIV3 Day 28 Post Dose 1|Post dose GMT of serum antibody response to PIV3 as measured by HAI assay. Limit of quantification is 4. For results reported as < 4, a value of 2 was imputed.|Day 28-34 after Dose 1 (Dose 1 was on Day 0)|The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for PIV3 and/or RSV.||GMT||95% Confidence Interval|Mean
742324|NCT00493285|Secondary|Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies to PIV3 at Baseline|Post dose GMT of serum antibody response to PIV3 as measured by HAI assay. Limit of quantification is 4. For results reported as < 4, a value of 2 was imputed.|Baseline (Day 0 prior to Dose 1)|The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for PIV3 and/or RSV.||GMT||95% Confidence Interval|Mean
742325|NCT00493285|Secondary|Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Day 28 Post Dose 3|Post dose GMT of serum antibody response to RSV as measured by microneutralization assay. Limit of quantification is 5. For results reported as < 5, a value of 2.5 was imputed.|Day 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for PIV3 and/or RSV.||GMT||95% Confidence Interval|Mean
742326|NCT00493285|Secondary|Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Day 28 Post Dose 2|Post dose GMT of serum antibody response to RSV as measured by microneutralization assay. Limit of quantification is 5. For results reported as < 5, a value of 2.5 was imputed.|Day 28-34 after Dose 2 (Dose 2 was on Day 48-64)|The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for PIV3 and/or RSV.||GMT||95% Confidence Interval|Mean
742327|NCT00493285|Secondary|Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Day 28 Post Dose 1|Post dose GMT of serum antibody response to RSV as measured by microneutralization assay. Limit of quantification is 5. For results reported as < 5, a value of 2.5 was imputed.|Day 28-34 after Dose 1 (Dose 1 was on Day 0)|The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for PIV3 and/or RSV.||GMT||95% Confidence Interval|Mean
742328|NCT00493285|Secondary|Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Baseline|Pre-dose GMT of serum antibody response to RSV as measured by microneutralization assay. Limit of quantification is 5. For results reported as < 5, a value of 2.5 was imputed.|Baseline (Day 0 prior to Dose 1)|The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for PIV3 and/or RSV.||GMT||95% Confidence Interval|Mean
742329|NCT00493285|Secondary|Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 3|Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.|Days 0-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|The shedding population included all subjects who received investigational product and had any valid shedding data.||participants|||Number
742330|NCT00493285|Secondary|Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 3|Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.|Days 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|The shedding population included all subjects who received investigational product and had any valid shedding data.||participants|||Number
742331|NCT00493285|Secondary|Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 3|Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.|Days 12-18 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|The shedding population included all subjects who received investigational product and had any valid shedding data.||participants|||Number
742332|NCT00493285|Secondary|Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 3|Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.|Days 7-10 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|The shedding population included all subjects who received investigational product and had any valid shedding data.||participants|||Number
742333|NCT00493285|Secondary|Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 2|Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.|Days 0-34 after Dose 2 (Dose 2 was on Day 48-64)|The shedding population included all subjects who received investigational product and had any valid shedding data.||participants|||Number
742334|NCT00493285|Secondary|Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 2|Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.|Days 28-34 after Dose 2 (Dose 2 was on Day 48-64)|The shedding population included all subjects who received investigational product and had any valid shedding data.||participants|||Number
742335|NCT00493285|Secondary|Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 2|Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.|Days 12-18 after Dose 2 (Dose 2 was on Day 48-64)|The shedding population included all subjects who received investigational product and had any valid shedding data.||participants|||Number
742336|NCT00493285|Secondary|Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 2|Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.|Days 7-10 after Dose 2 (Dose 2 was on Day 48-64)|The shedding population included all subjects who received investigational product and had any valid shedding data.||participants|||Number
742337|NCT00493285|Secondary|Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 1|Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.|Days 0-34 after Dose 1 (Dose 1 was on Day 0)|The shedding population included all subjects who received investigational product and had any valid shedding data.||participants|||Number
742338|NCT00493285|Secondary|Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 1|Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.|Days 28-34 after Dose 1 (Dose 1 was on Day 0)|The shedding population included all subjects who received investigational product and had any valid shedding data.||participants|||Number
742339|NCT00493285|Secondary|Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 1|Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.|Days 12-18 after Dose 1 (Dose 1 was on Day 0)|The shedding population included all subjects who received investigational product and had any valid shedding data.||participants|||Number
742340|NCT00493285|Secondary|Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 1|Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.|Days 7-10 after Dose 1 (Dose 1 was on Day 0)|The shedding population included all subjects who received investigational product and had any valid shedding data.||participants|||Number
742341|NCT00493285|Secondary|Number of Participants Shedding Vaccine-like Virus at Any Time During Study Participation|Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.|Days 7, 12, and 28 after each dose and during visits for pre-specified illness symptoms occurring Day 0 through 28-34 days post each dose.|The shedding population included all subjects who received investigational product and had any valid shedding data.||participants|||Number
742342|NCT00493285|Primary|Number of Participants With Significant New Medical Conditions (SNMCs)|A SNMC is a newly diagnosed medical condition that is of a chronic, ongoing nature and is assessed by the investigator as medically significant.|Day 0 through 180 days after the final dose or through the end of the RSV season, whichever was later|Safety population was participants who received investigational product and had any safety follow-up for ≥ 1 day after dosing (ie, did not discontinue on Day 0 after receiving Dose 1).||participants|||Number
742409|NCT00494143|Secondary|Prosthetic Foot Push Off Peak Power|The biomechanical measurement of the power generated by the prosthetic foot during the push off component of stance phase. The peak power output during the push off component of stance phase was calculated in Joules. It was subsequently standardized for body weight in Kgs. The final units were therefore Joules/Kg.|Subjects were oriented to the testing protocol and each prosthetic foot on average 5 days prior to data collection and a acclimatization period of 5-10 minutes with each prosthetic foot prior to data collection|||joules per kilogram||Standard Deviation|Mean
742343|NCT00493285|Primary|Number of Participants With Serious Adverse Events (SAEs)|Events resulting in death; were life-threatening; resulted in inpatient hospitalization/prolongation of hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly/birth defect in the offspring of a participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and may have jeopardized the participant and required medical/surgical intervention to prevent one of the above outcomes.|Days 0-28 after any dose|The safety population included all subjects who received investigational product for the specified dose and had any safety follow-up.||participants|||Number
742344|NCT00493285|Primary|Number of Subjects With Medically-attended Lower Respiratory Illnesses (MA-LRIs)|An MA-LRI was a healthcare provider-confirmed diagnosis of 1 or more of the following: wheezing, pneumonia, croup, rhonchi (not cleared with cough or suctioning), rales, bronchitis, bronchiolitis, apnea.|Days 0 to 180 days after final dose or the end of the RSV season, whichever was later|The safety population for MA-LRIs included randomized participants who received investigational product and had any safety follow-up.||participants|||Number
742345|NCT00493285|Primary|Number of Participants With AEs After Dose 3|Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 3.|Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|The safety population for AEs included randomized participants who received investigational product for the specified dose and had any safety follow-up.||participants|||Number
742346|NCT00493285|Primary|Number of Participants With AEs After Dose 2|Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 2.|Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)|The safety population for AEs included randomized participants who received investigational product for the specified dose and had any safety follow-up.||participants|||Number
742347|NCT00493285|Primary|Number of Participants With Adverse Events (AEs) After Dose 1|Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 1.|Days 0-28 after Dose 1 (Dose 1 was on Day 0)|The safety population for AEs included randomized participants who received investigational product for the specified dose and had any safety follow-up.||participants|||Number
742348|NCT00493285|Primary|Number of Participants With SEs After Dose 3|The SEs for this study included fever ≥ 100.4°F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, laryngitis, and epistaxis.|Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|Safety population for solicited symptoms included randomized participants who received investigational product for the specified dose and had any solicited symptom data obtained after that dose||participants|||Number
742349|NCT00493285|Primary|Number of Participants With SEs After Dose 2|The SEs for this study included fever ≥ 100.4°F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, laryngitis, and epistaxis.|Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)|Safety population for solicited symptoms included randomized participants who received investigational product for the specified dose and had any solicited symptom data obtained after that dose.||participants|||Number
742350|NCT00493285|Primary|Number of Participants With Solicited Adverse Events (SEs) After Dose 1|The SEs for this study included fever ≥ 100.4°F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, laryngitis, and epistaxis.|Days 0-28 after Dose 1 (Dose 1 was on Day 0)|Safety population for solicited symptoms included randomized participants who received investigational product for the specified dose and had any solicited symptom data obtained after that dose||participants|||Number
742351|NCT00493311|Secondary|Global Assessment of Treatment at T360 Minutes or Early Termination.|"Subject Global Evaluation was assessed by subject using a 4 point categorical scale in response to the following question:Overall, how would you rate the study treatments? 0 = Poor
= Fair
= Good
= Excellent"|Baseline (T0) to 6 hours|||participants|||Number
742352|NCT00493311|Secondary|The Percentage of Subjects With Temperature Less Than 38 Degrees Celsius at Any Timepoint During the Time From T0 to T360 Minutes (6 Hours After Study Drug Administration)||360 minutes (6 hours after study drug administration)|||Percentage of participants|||Number
742353|NCT00493311|Secondary|Maximum Temperature Change During the Period From T0 to T360 Minutes (6 Hours After Study Drug Administration)||Baseline (T0) to 360 minutes (6 hours) post study drug administration|||Degrees celsius||Standard Deviation|Mean
742354|NCT00493311|Secondary|Weighted Sum of Temperature Differences Over 3 Hours (WSTD3) Assessment of the Antipyretic Effect Over 3 Hours of a Single Dose of IV APAP vs. Placebo for Treatment of Endotoxin-induced Fever.|WSTD3 is defined as the weighted sum of temperature differences from the temperature at each assessment timepoint through the first 3 hours compared with the temperature at T0, weighted by the time elapsed between each 2 consecutive timepoints.|Baseline (T0) to 3 hours|||Degrees Celsius||Standard Deviation|Mean
742355|NCT00493311|Primary|Weighted Sum of Temperature Differences Over 6 Hours (WSTD6) Assessment of the Antipyretic Effect Over 6 h of a Single Dose of IV APAP vs. Placebo for Treatment of Endotoxin-induced Fever|The primary efficacy endpoint was WSTD6 defined as the weighted sum of temperature differences from the temperature at each assessment timepoint through 6 hours compared with the temperature at T0, weighted by the time elapsed between each 2 consecutive timepoints.|Baseline (T0) to 6 hours post study drug administration|||Degrees Celsius||Standard Deviation|Mean
742356|NCT00493454|Primary|Objective Response Rate|Objective response rate (ORR) = number of participants out of all participating with Complete Response (CR) + Partial Response (PR) as defined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Partial response (PR) must have ≥ 30% decrease in the sum of longest diameter of all target lesions, from the baseline sum. Complete response (CR) must have disappearance of all target and non-target lesions. Response assessed by magnetic resonance imaging (MRI) or computed tomography (CT) scans, every 3 months for the first year and every 6 months up to 3 years following.|Evaluation 4 weeks after administration of Zevalin up to 3 years|One participant did not receive treatment and was excluded from analysis.||proportion of participants|||Number
742432|NCT00494494|Primary|Macular Volume (Difference in Mean Pre-post Changes by the Two Treatment Groups)||baseline and 8 weeks|||microns||95% Confidence Interval|Mean
742357|NCT00493636|Secondary|Duration of Overall Response|Duration of overall response was calculated as the time (days) from first documentation of CR or PR (whichever status is recorded first) until the first date that recurrent or progressive disease (PD) or death is objectively documented. Response was evaluated via changes from baseline in radiological tumor measurements using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is >=30% decrease in the sum of the longest diameter (LD) of target lesions; Stable Disease (SD) is neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of >=20%; Progressive Disease (PD) is the increase in existing lesions or new lesions.|Period measured from the first documentation of complete or partial response (whichever status is recorded first) until the first date that recurrent or progressive disease or death is objectively documented.|||Days||95% Confidence Interval|Median
742358|NCT00493636|Secondary|Overall Response Rate|Overall response rate was defined as the proportion of participants experiencing complete response (CR) and partial response (PR) as best overall response. Response was evaluated via changes from baseline in radiological tumor measurements using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is >=30% decrease in the sum of the longest diameter (LD) of target lesions; Stable Disease (SD) is neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of >=20%; Progressive Disease (PD) is the increase in existing lesions or new lesions.|The overall tumor burden at baseline will be compared with subsequent measurements up to the date of first documented disease progression or the date of death due to any cause, if before progression, assessed up to 39 months.|||percentage of participants|||Number
742359|NCT00493636|Secondary|Time to Progression||Calculated as the time (days) from date of randomization to date of first observed disease progression (radiological or clinical, whichever is earlier), assessed up to 39 months.|||Days||95% Confidence Interval|Median
742360|NCT00493636|Secondary|Overall Survival||From the date of randomization to date of death due to any cause, assessed up to 56 months.|||Days||95% Confidence Interval|Median
742361|NCT00493636|Primary|Progression Free Survival||From the date of randomization to date of first documented disease progression (i.e., the date on which a radiologic procedure or clinical evaluation was performed) or the date of death due to any cause, if before progression, assessed up to 39 months.|||Days||95% Confidence Interval|Median
742362|NCT00493649|Secondary|OS by cMyc Expression in This Population of HER2+ ESBC Patients Treated With TC+H.|OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.|2 years|ITT population. Patients were excluded if their cMYC amplification were unknown.||probability of overall survival||95% Confidence Interval|Number
742363|NCT00493649|Secondary|DFS by cMyc Expression in This Population of HER2+ ESBC Patients Treated With TC+H.|DFS was measured from the date of registration to either the date the patient was first recorded as having disease recurrence, or the date of death due to any causes before recurrence. If a patient had not recurred or died, DFS was censored at the date of last follow-up.|2 years|ITT population. Patients were excluded if their cMYC amplification were unknown.||probability of disease-free survival||95% Confidence Interval|Number
742364|NCT00493649|Secondary|Overall Survival (OS) Rate at 2 Years in TOP2A-amplified and in TOP2A-nonamplified HER2+ ESBC Patients Treated With TC+H.|OS is measured from the date of registration to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.|2 years|ITT population. Patients were excluded if their TOP2A amplification were unknown.||probability of overall survival||95% Confidence Interval|Number
742365|NCT00493649|Primary|Disease-free Survival (DFS) Rate at 2 Years in TOP2A-amplified and in TOP2A-nonamplified HER2+ ESBC Patients Treated With TC+H.|DFS was measured from the date of registration to either the date the patient was first recorded as having disease recurrence, or the date of death due to any causes before recurrence. If a patient had not recurred or died, DFS was censored at the date of last follow-up.|2 years|ITT population. Patients were excluded if their TOP2A amplification were unknown.||probability of disease-free survival||95% Confidence Interval|Number
742366|NCT00493779|Secondary|Adverse Events (AE) / Serious Adverse Events (SAE)Deaths, and AEs Leading to Discontinuation of Follow-up|An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a patient or clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.|Throughout 4-week follow-up period|All enrolled patients in whom clopidogrel treatment was discontinued.||Participants|||Number
742367|NCT00493779|Secondary|Adjusted Mean Percent Changes From Baseline in Hs-CRP|ANCOVA models performed on log scale controlling for site & natural logarithm of baseline hs-CRP. Back-transformed mean percent changes are presented. Percent changes from baseline can be interpreted as difference of biomarker timepoint value - baseline value ÷ baseline value. Since there is no measure of platelet inhibition or overall thrombogenicity assay presented here, a negative percent change for this measure can not be judged on its own as indicating improvement.|Week 1, Week 2, Week 3, Week 4|Number of patients in the biomarker analysis population having baseline hs-CRP value and at least one post clopidogrel withdrawal measurement for hs-CRP value. No imputation technique for missing values was applied.||percent change||Standard Error|Mean
742368|NCT00493779|Primary|Adjusted Mean Percent Changes From Baseline in Soluble CD40 Ligand (sCD40L)|Based on ANCOVA models performed on log scale controlling for site & natural logarithm of baseline soluble CD40 Ligand value. Percent changes from baseline can be interpreted as the difference of biomarker timepoint value minus baseline value divided by baseline value. Positive percent change might indicate possible enhanced platelet activation.|Week 1, Week 2, Week 3, Week 4 (primary timepoint)|Number of participants in the biomarker analysis population having a baseline soluble CD40 Ligand value (n=95) and at least one post-clopidogrel withdrawal measurement for soluble CD40 Ligand value. No imputation technique for missing values was applied.||percent change||Standard Error|Mean
742433|NCT00494494|Primary|Foveal Thickness|difference in mean pre-post changes by the two treatment groups|baseline and 8 weeks|||microns||95% Confidence Interval|Mean
745617|NCT00517192|Secondary|Time to Virologic Failure Through 48 Weeks of Treatment, Using VL < 400 Copies/mL as the Response Criterion.||48 weeks of treatment||||||
742369|NCT00493779|Secondary|Adjusted Mean Percent Changes From Baseline in Plasma Soluble P-Selectin|Based on ANCOVA models performed on log scale controlling for site and natural logarithm of baseline Plasma Soluble P-selectin value. Percent changes from baseline can be interpreted as difference of biomarker timepoint value minus baseline value divided by baseline value. Positive percent change is known to be mediated by increases in sCD40L.|Week 1, Week 2, Week 3, Week 4|Number of patients in the biomarker analysis population having baseline Plasma Soluble P-selectin value (n=95) and at least one post-clopidogrel withdrawal measurement for Plasma Soluble P-selectin value. No imputation technique for missing values was applied.||percent change||Standard Error|Mean
742370|NCT00493805|Secondary|Sustained Virological Response (PCR 24 Weeks After End of Treatment)|Sustained virological response (SVR) was defined as undetectable HCV RNA in serum at the end of follow-up (24 weeks after end of therapy) according to a polymerase chain reaction (PCR) assay.|Up to 24 weeks following 48 or 72 weeks of therapy|Information on PCR was available for 7 participants in the non interventional study arm and 11 participants in the interventional study arm.||Participants|||Number
742371|NCT00493805|Primary|Early Virological Response in Participants With and Without Insulin Resistance|Early Virological Response (EVR) defined as HCV PCR at Week 12 either negative or at least 2 log units less than baseline in participants with and without insulin resistance.|At Week 12 (after start of therapy)|"Interventional arm: At baseline, PCR measurements for 38 out of 42 participants were available.
Non Interventional arm: At baseline, PCR measurements for 15 out of 17 participants were available."||Participants|||Number
742372|NCT00493974|Secondary|Change in Urinary Leukotriene (LTE4) Levels|Change in natural log-transformed LTE4 (ng/mg Cr.) from Baseline to 72 Hours|Baseline and 72 hours later|"Intent to Treat.
Participants with urine sample at both visits."||(ng/mg Cr.)||Standard Error|Log Mean
742373|NCT00493974|Secondary|Change in Urinary Leukotriene (LTE4) Levels|Change in natural log-transformed LTE4 (ng/mg Cr.) from Baseline to 24 Hours|Baseline and 24 hours|"Intent to Treat.
Participants with urine sample at both visits."||(ng/mg Cr.)||Standard Error|Log Mean
742374|NCT00493974|Secondary|Health-related Quality of Life|"St. George's Respiratory Questionnaire - Total Score
The SGRQ was asked with respect to the last one month as validated for acute exacerbations of COPD by Doll et al.
Scale from 0 (no disability) to 100 (maximum disability).
The SGRQ total score summarizes the impact of airway specific disease on overall health status. Scores range from zero (no impairment) to 100 (maximum impairment). Scores were calculated using the SGRQ scoring Algorithm."|Change from Baseline and 1 Month|Participants were analyzed using the intent to treat method and included those that had SGRQ data at baseline and 1 month.||Units on a scale||Standard Deviation|Mean
742375|NCT00493974|Secondary|Treatment Failure|Treatment failure is defined as death, intubation, readmission to a hospital for COPD, urgent visit to an outpatient or ED provider for symptoms of COPD or intensification of therapy [including second course of antibiotics for COPD, and second course of systemic steroids for COPD]) in the first 30 days after randomization.|Baseline to day 30 visit|Participants were analyzed following intention to treat (ITT) method.||Participants|||Number
742376|NCT00493974|Secondary|Change in FEV1/FEV6 Levels|Change in Post-bronchodilator FEV1/FEV6 ratio comparing data at discharge visit with baseline.|from baseline to day of discharge|Participants were analyzed using the intent to treat method. The N is lower than total randomized due to participants that were unable to perform spirometry at baseline and missing discharge data.||ratio||Standard Error|Mean
742377|NCT00493974|Secondary|Change in FEV1% Predicted|Change in Post-bronchodilator FEV1% predicted comparing data at 30 day visit with baseline.|Measured at Baseline and Day 30|Participants were analyzed using the intent to treat method. The N is lower than total randomized due to participants that were unable to perform spirometry at baseline.||percent predicted||Standard Error|Mean
742378|NCT00493974|Primary|Length of Hospital Stay|Admission will begin at the time the subject has been admitted to an inpatient service. Length of Stay (LOS) will be recorded in days. The LOS will be based on the number of days spent in an acute medical ward or in the ICU. Subjects that are admitted and discharged in the same 24 hour period will be recorded as a LOS of 1 day, as will subjects discharged in the ensuing 24 hour period. LOS's greater than 10 days will be truncated to 10 days.|Measured at Day 30|"Participants were analyzed following intention to treat (ITT) method.
One participant randomized to Zileuton withdrew consent before hospital discharge.
Days to discharge are set at a maximum of 10 days."||Days||Standard Deviation|Median
742379|NCT00494013|Secondary|Number of Injections of Basal Insulin Analog at Endpoint||24 Weeks|Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement. Last observation carried forward.||participants|||Number
742380|NCT00494013|Secondary|Total Daily Insulin Dose Per Body Weight (Units/Kilograms) at Endpoint|Insulin dose at endpoint was analyzed by 24-hour total daily insulin per body weight (Units/kilograms).|24 Weeks|Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement. Last observation carried forward.||Units of Insulin/kilograms (U/kg)||Standard Deviation|Mean
742381|NCT00494013|Secondary|Total Daily Insulin Dose (Units) at Endpoint|Insulin dose at endpoint was analyzed by 24-hour total daily insulin (units).|24 Weeks|Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement. Last observation carried forward.||Units of insulin||Standard Deviation|Mean
742382|NCT00494013|Secondary|Change in Absolute Body Weight (kg) From Baseline to 24 Week Endpoint||Baseline, 24 Weeks|Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement. Last observation carried forward.||kilograms (kg)||Standard Deviation|Mean
742383|NCT00494013|Secondary|30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall|Overall: any time after randomization. Hypoglycemic: any time patient experienced sign/symptom associated with hypoglycemia, or had old Roche blood glucose level <7 mg/dL. Nocturnal: any hypoglycemic event that occurred between bedtime and waking. Severe: event with symptoms consistent with neuroglycopenia in which patient requires assistance, and is associated with: a Roche blood glucose value <2.8 mmol/L or prompt recovery after oral carbohydrate, glucagon, or IV glucose. 30-day adjusted rate=(total number of episodes between 2 time intervals/number of days between intervals) X 30 days.|Baseline to 24 Weeks|Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement.||hypoglycemic events per 30 days||Standard Deviation|Mean
743558|NCT00486291|Primary|Change From Baseline in HbA1c at Week 28.||Baseline to 28 weeks|Intent-to-treat Last-observation-carried-forward (ITT-LOCF)||percent change||Standard Error|Least Squares Mean
742384|NCT00494013|Secondary|1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall|Overall: any time after randomization. Hypoglycemic: any time patient experienced sign/symptom associated with hypoglycemia, or had old Roche blood glucose level <7 mg/dL. Nocturnal: any hypoglycemic event that occurred between bedtime and waking. Severe: event with symptoms consistent with neuroglycopenia in which patient requires assistance, and is associated with: a Roche blood glucose value <2.8 mmol/L or prompt recovery after oral carbohydrate, glucagon, or IV glucose. 1-year adjusted rate=(total number of episodes between 2 time intervals/number of days between intervals) X 365.25 days.|Baseline to 24 Weeks|Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement.||hypoglycemic events per 1 year||Standard Deviation|Mean
742385|NCT00494013|Secondary|Number of Participants With Self-reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe Hypoglycemia) Overall for All Study Periods|Overall: any time after randomization. Hypoglycemic: any time patient experienced sign/symptom associated with hypoglycemia, or had old Roche blood glucose level <7 mg/dL. Nocturnal: any hypoglycemic event that occurred between bedtime and waking. Severe: event with symptoms consistent with neuroglycopenia in which patient requires assistance, and is associated with: a Roche blood glucose value <2.8 mmol/L or prompt recovery after oral carbohydrate, glucagon, or IV glucose. Results are for the combined titration and maintenance periods.|Baseline to 24 Weeks|Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement.||participants|||Number
742386|NCT00494013|Secondary|7-point Self-monitored Blood Glucose (SMBG) Profile at Endpoint|Actual daily mean blood glucose levels at endpoint.|24 Weeks|Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement. Last observation carried forward.||millimoles per liter (mmol/L)||Standard Deviation|Mean
742387|NCT00494013|Secondary|Glycemic Variability|Glycemic variability was measured by standard deviation (SD) value of fasting blood glucose as measured by intra-patient glycemic variability (determined by the 7-point self-monitoring blood glucose [SMBG] profiles at endpoint) for the actual morning pre-meal blood glucose value.|24 Weeks|Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement. Last observation carried forward.||millimoles per Liter (mmol/L)||Standard Deviation|Mean
742388|NCT00494013|Secondary|Percentage of Patients With HbA1c <7.0% and HbA1c < or = 6.5% at Endpoint|Percentage of patients achieving Hemaglobin A1c (HbA1c) targets of less than 7.0% and less than or equal to 6.5% at endpoint.|24 Weeks|Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement. Last observation carried forward.||percentage of participants|||Number
742389|NCT00494013|Secondary|Actual and Change From Baseline Hemoglobin A1c (HbA1c) Value at 12 Weeks and at 24 Weeks||Baseline, 12 Weeks, 24 Weeks|Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement.||percent hemoglobin||Standard Error|Least Squares Mean
742390|NCT00494013|Primary|Change From Baseline to 24 Week Endpoint in Hemoglobin A1c (HbA1c)||Baseline, 24 Weeks|Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement. Last observation carried forward.||percent of HbA1c||Standard Error|Least Squares Mean
742391|NCT00494026|Secondary|Pharmacology Toxicity|Radiation Therapy Oncology Group (RTOG) criteria were used for assessing toxicity. Toxicity grade reflected the most severe degree occurring during the evaluated period, not an average. When two criteria were available for similar toxicities, the one resulting in the more severe grade was used. Toxiccity grades range from 0 to 5. Toxicity grade = 5 if that toxicity caused the death of the patient.|every 21-day cycle for 4 cycles|All enrolled patients who received radiotherapy.||participants|||Number
742392|NCT00494026|Secondary|Duration of Response|The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.|time of response to progressive disease|Trial was terminated early. Results were not analyzed.||months||95% Confidence Interval|Median
742393|NCT00494026|Secondary|Overall Survival|Overall survival is the duration from enrollment to death (includes 1 year follow-up). For patients who are alive, overall survival is censored at the last contact.|baseline to date of death from any cause, 1 year|Trial was terminated early. Results were not analyzed.||months||95% Confidence Interval|Median
742394|NCT00494026|Secondary|Progression-free Survival|Defined as the time from date of first dose to the first observation of disease progression, or death due to any cause.|baseline to measured progressive disease|Trial was terminated early. Results were not analyzed.||months||95% Confidence Interval|Median
742395|NCT00494026|Primary|Proportion of Patients With a Complete or Partial Response (Overall Response Rate [ORR])|Overall Response Rate (ORR) was defined as the proportion of participants having either a Complete or Partial response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions.|baseline to measured response after chemotherapy and radiation|Trial was stopped too early to assess the primary endpoint.||proportion of responders|||Number
742396|NCT00494091|Other Pre-specified|Volume of Distribution at Steady State (Vss) of Temsirolimus|"Vss is an estimate of the volume of distribution at steady state. It is used to predict the plasma concentrations following multiple dosing to a steady-state or pseudo-equilibrium. Vss is proportional to the amount of drug in the body versus the plasma concentration of the drug at steady state. As per planned analysis, only participants in Temsirolimus 20 mg/m^2 treatment arm were to be drawn blood samples intensively for pharmacokinetic analysis."|0 hours (pre-dose), 0.5, 1, 2, 6, 24, 72, and 96 hours during Week 1 and 4 of treatment|PK population included all participants who received at least 1 dose of study treatment and had at least 3 measurable blood concentration samples available. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.||Liter||Standard Deviation|Mean
748845|NCT00538642|Secondary|Systolic Blood Pressure||Baseline|||mm Hg||Standard Deviation|Mean
742397|NCT00494091|Other Pre-specified|Clearance (CLss) of Temsirolimus|"Steady state total body clearance equals infusion rate (zero order) divided by steady state plasma concentration of temsirolimus (R0/Css). As per planned analysis, only participants in Temsirolimus 20 mg/m^2 treatment arm were to be drawn blood samples intensively for pharmacokinetic analysis."|0 hours (pre-dose), 0.5, 1, 2, 6, 24, 72, and 96 hours during Week 1 and 4 of treatment|Pharmacokinetic (PK) population included all participants who received at least 1 dose of study treatment and had at least 3 measurable blood concentration samples available. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.||Liter per hour (L/h)||Standard Deviation|Mean
742398|NCT00494091|Other Pre-specified|Area Under the Concentration-Time Curve (AUC)|"AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. Sirolimus is the major metabolite of temsirolimus. As per planned analysis, only participants in Temsirolimus 20 mg/m^2 treatment arm were to be drawn blood samples intensively for pharmacokinetic analysis."|0 hours (pre-dose), 0.5 hours, 1, 2, 6, 24, 72, and 96 hours during Week 1 and 4 of treatment|PK population included all participants who received at least 1 dose of study treatment and had at least 3 measurable blood concentration samples available. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.||ng*h/mL||Standard Deviation|Mean
742399|NCT00494091|Other Pre-specified|Plasma Decay Half-Life (t1/2)|"Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Sirolimus is the major metabolite of temsirolimus. As per planned analysis, only participants in Temsirolimus 20 mg/m^2 treatment arm were to be drawn blood samples intensively for pharmacokinetic analysis."|0 hours (pre-dose), 0.5, 1, 2, 6, 24, 72, and 96 hours during Week 1 and 4 of treatment|Pharmacokinetic (PK) population included all participants who received at least 1 dose of study treatment and had at least 3 measurable blood concentration samples available. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.||hours||Standard Deviation|Mean
742400|NCT00494091|Other Pre-specified|Time to Reach Maximum Observed Plasma Concentration (Tmax)|"Sirolimus is a major metabolite of temsirolimus. As per planned analysis, only participants in Temsirolimus 20 mg/m^2 treatment arm were to be drawn blood samples intensively for pharmacokinetic analysis."|0 hours (pre-dose), 0.5, 1, 2, 6, 24, 72, and 96 hours during Week 1 and 4 of treatment|PK population included all participants who received at least 1 dose of study treatment and had at least 3 measurable blood concentration samples available. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.||hours||Full Range|Median
742401|NCT00494091|Other Pre-specified|Maximum Observed Plasma Concentration (Cmax)|"Sirolimus is a major metabolite of temsirolimus. As per planned analysis, only participants in Temsirolimus 20 mg/m^2 treatment arm were to be drawn blood samples intensively for pharmacokinetic analysis."|0 hours (pre-dose), 0.5 hours, 1, 2, 6, 24, 72, and 96 hours during Week 1 and 4 of treatment|Pharmacokinetic (PK) population included all participants who received at least 1 dose of study treatment and had at least 3 measurable blood concentration samples available. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
742402|NCT00494091|Secondary|Overall Survival (OS)|Time in months from the date of enrollment to date of death due to any cause. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Baseline Until Death (Up to 4 years)|ITT population included all participants who were enrolled in this study.||months||95% Confidence Interval|Median
742403|NCT00494091|Secondary|Time to Treatment Failure (TTF)|TTF is defined as the time from the date of enrollment to the date of the first documentation of PD, the date of treatment discontinuation except completion of treatment, or date of death due to cancer.|Baseline Up to 4 years|ITT population included all participants who were enrolled in this study.||months||95% Confidence Interval|Median
742404|NCT00494091|Secondary|Duration of Response|Time measurement criteria are met for CR or PR (whichever status is recorded first) until the first date that recurrence or PD is objectively documented, taking as reference for PD the smallest sum longest diameters (LD) recorded since enrollment.|Baseline Up to 4 years|Intent-to-treat ITT population included all participants who were enrolled in this study. Here N (number of participants analyzed) signifies participants with objective disease response.||months||95% Confidence Interval|Median
742405|NCT00494091|Secondary|Percentage of Participants With Objective Response|Percentage of participants with objective response based assessment of confirmed CR or confirmed PR according to Response Evaluation Criteria In Solid Tumors (RECIST). CR is disappearance of all target lesions. PR shows at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.|Baseline Up to 4 years|ITT population included all participants who were enrolled in this study.||percentage of participants||95% Confidence Interval|Number
742406|NCT00494091|Secondary|Progression-free Survival (PFS)|Median time from the date of enrollment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first.|Baseline Up to 4 years|ITT population included all participants who were enrolled in this study.||months||95% Confidence Interval|Median
742407|NCT00494091|Primary|Percentage of Participants With Clinical Benefit|Clinical benefit: confirmed complete response (CR) or partial response (PR) or had stable disease (SD) lasting at least 24 weeks. CR was the disappearance of all target lesions and nontarget lesions. PR was at least a 30 percent (%) decrease in sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. SD was having neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD).|Baseline Up to 4 years|Intent-to-treat (ITT) population included all participants who were enrolled in this study.||percentage of participants||95% Confidence Interval|Number
742408|NCT00494143|Secondary|Peak Intact Knee Loading|The biomechanical measure of the first peak of the knee external adduction moment|Subjects were oriented to the testing protocol and each prosthetic foot on average 5 days prior to data collection and a acclimatization period of 5-10 minutes with each prosthetic foot prior to data collection|||newton meters per kilogram||Standard Deviation|Mean
742430|NCT00494481|Primary|Number of Patients With a Disease Progression Event|Number of patients with objective disease progression or death (by any cause in the absence of objective progression)|RECIST tumour assessments carried out at screening (within 3 weeks before the 1st dose) and then as per site clinical practice until objective progression. The only additional mandatory RECIST assessment is at the point of data cut-off|||Participants|||Number
742410|NCT00494143|Primary|Metabolic Oxygen Consumption During Ambulation|VO2 was collected at rest and while walking at a controlled walking speed of 1.14 meters/second for 10 minutes until they reached a steady state for 3 minutes. This was repeated for each foot condition. VO2 at the steady state was recorded in ml/min and were subsequently converted to calories and and then to Watts. The data were then corrected for body weight by dividing by weight in Kg. The gross VO2 in Watts/Kg during walking were then adjusted to net VO2 in Watts/kg by subtracting the resting metabolic rate.|Subjects were oriented to the testing protocol and each prosthetic foot on average 5 days prior to data collection and a acclimatization period of 5-10 minutes with each prosthetic foot prior to data collection|||Watts per kilogram||Standard Deviation|Mean
742411|NCT00494221|Secondary|Overall Survival|Number of months until death (censored if still alive at date cut-off). Median non-estimable if >50% of subjects within a group are censored.|Randomisation until cut-off date 13OCT2009 (based on approximately 105 progression events observed across the 3 groups)|||Months||Full Range|Median
742412|NCT00494221|Secondary|Duration of Response|Number of months from Complete/Partial response until progression up to cut-off date 13OCT2009 (based on approximately 105 progression events observed across the 3 groups).|RECIST at Baseline, Weeks 6, 12, 18, 24 and then every 12 weeks until progression through to a cut-off date of 13th Oct 2009 (based on approx 105 progression events observed across the 3 groups)|||Months||Standard Deviation|Mean
742413|NCT00494221|Secondary|Best Percentage Change in Tumour Size|Best percentage change in tumour size from baseline, based on the sum of the longest diameters of the target lesions|Randomisation until cut-off date 13OCT2009 (based on approximately 105 progression events observed across the 3 groups)|||Percentage||Standard Deviation|Mean
742414|NCT00494221|Secondary|Objective Tumour Response Rate|Number of patients with complete (CR) /partial response (PR) (based on RECIST). CR is defined as Disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of Longest Diameter (LD) of target lesions taking as reference the baseline sum LD.|RECIST at Baseline, Weeks 6, 12, 18, 24 and then every 12 weeks until progression through to a cut-off date of 13th Oct 2009 (based on approx 105 progression events observed across the 3 groups)|||Participants|||Number
742415|NCT00494221|Primary|Progression Free Survival|Number of months from randomisation until progressive disease based on RECIST (progression of target lesions, clear progression of existing non-target lesions or the appearance of one or more new lesions) or death in the absence of progression.|RECIST at Baseline, Weeks 6, 12, 18, 24 and then every 12 weeks until progression through to a cut-off date of 13th Oct 2009 (based on approx 105 progression events observed across the 3 groups)|||Months||Full Range|Median
742416|NCT00494234|Secondary|Change From Baseline in ECOG Performance Status: Improvement Rate|The change in ECOG performance status was defined as improved (meaning the ECOG score is less than the baseline value), no change (ECOG is same as at baseline), worsened (ECOG score is greater than the baseline value) or missing (the ECOG score is missing or was not recorded at baseline). If no measurement was recorded at Cycle 1 Day 1, the change was calculated in relation to the last recorded ECOG value prior to Day 1.|At cycle 7 day 1 (ie, after completing 6 cycles of treatment)|||Participants with an improvement in ECOG|||Number
742417|NCT00494234|Secondary|Progression-Free Survival (PFS)|PFS is defined as the time from first dose to the earlier date of radiologic progression (as per RECIST criteria) or death by any cause in the absence of objective progression. Those patients who were withdrawn from the study without disease progression were regarded as censored at their last evaluable RECIST assessment. Where patients had not progressed at the termination of the study, they were also regarded as censored at their last evaluable RECIST assessment.|End of study|||Days||95% Confidence Interval|Median
742418|NCT00494234|Secondary|Best Percent Change in Tumour Size|The tumour size is defined as the sum of the longest diameters as measured among all target lesions.|End of study|||Percent change in tumour size||95% Confidence Interval|Mean
742419|NCT00494234|Secondary|The Clinical Benefit Rate (CBR)|The Clinical Benefit Rate (CBR) is defined as the percentage of patients with a RECIST tumour response of confirmed CR, PR or stable disease (SD) for ≥8 weeks +/- 1 week visit window.|End of study|Per protocol||Percentage of Participants||95% Confidence Interval|Number
742420|NCT00494234|Secondary|Duration of Response to Olaparib||Time from response (CR or PR) to progression per RECIST criteria|Per protocol||Days||Full Range|Median
742421|NCT00494234|Primary|Confirmed Objective Tumour Response (According to RECIST Criteria)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease from baseline in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Baseline, every 8 also at study termination or initiation of confounding anti-cancer therapy. Up to 2 years.|||Participants|||Number
742422|NCT00494299|Post-Hoc|Number of Death Cases Due to Any Cause||From randomization of the first subject until death due to any cause assessed up to 55 months.|"Intention to treat (ITT) population. Overall Survival is shown in Secondary Outcome Measure: Overall Survival."||Participants|||Number
742423|NCT00494299|Secondary|Overall Survival (OS)|Overall survival (OS) was defined as the time from date of randomization to death due to any cause. Subjects still alive at their last date of follow-up were censored at the time of analysis.|From randomization of the first subject until 39 months later.|"Median overall survival (OS) and 95% Confidence interval (CI) were not estimable in Placebo Group and Upper Limit of 95% CI was not in Sorafenib Group because of more than half (188 for Placebo,186 for Sorafenib) of the individual study populations censored. Number of death is shown in Post-Hoc Outcome Measure."|||||
742424|NCT00494299|Primary|Time to Progression (TTP)|Time to progression (TTP) was defined as the time from date of randomization to radiological progression / recurrence. Subjects without progression at the time of analysis were censored at their last date of tumor evaluation.|From randomization of the first subject until radiological progression or recurrence whichever came first, assessed up to 39 months.|Intention to treat (ITT) population.||days||95% Confidence Interval|Median
742434|NCT00494494|Primary|Pre-operative Best Corrected Visual Acuity (BCVA)|Patients were instructed to read letters on the EDTRS visual acuity chart. The mean and standard deviation for each group was measured. Letters range from 0 (20/2000) to 110 (20/12.5), with the higher number signaling better visual acuity.|baseline|The analysis was per protocol. At baseline, everybody was given a Best Corrected Visual Acuity Assessment (BCVA).||letters||Standard Deviation|Mean
742435|NCT00494494|Primary|Central Macular Thickness (Difference in Mean Pre-post Changes by the Two Treatment Groups)|The endpoints of the study were change in macular thickness measured by OCT in the central 1mm diameter centred on the fovea (central macular thickness)|baseline and 8 weeks|Three subjects in the treatment group and two subjects in the control group had unreliable preoperative OCT scans because of dense posterior subcapsular cataracts. These subjects were excluded from the analysis.||microns||95% Confidence Interval|Mean
742436|NCT00494507|Secondary|HOP Change From Baseline to Week 9 in SF-36 Mental Health Component Summary Score|The Medical Outcomes Study Short Form (SF-36) questionnaire is a widely used profile measure of generic health-related quality of life. The 36 questions are allocated to eight scales: physical function (PF), physical role (RP), bodily pain (BP), general health perceptions (GH), vitality (VT), social function (SF), mental health (MH), and emotional role (RE). The mental health component summary score is calculated from the four scales of VT, SF, MH, and RE. Scores are constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score. Higher scores are associated with better quality of life.|Baseline and 9 weeks|Participants with evaluable data at both timepoints||T-score||Standard Deviation|Mean
742437|NCT00494507|Secondary|HYP Change From Baseline to Week 9 in SF-36 Mental Health Component Summary Score|The Medical Outcomes Study Short Form (SF-36) questionnaire is a widely used profile measure of generic health-related quality of life. The 36 questions are allocated to eight scales: physical function (PF), physical role (RP), bodily pain (BP), general health perceptions (GH), vitality (VT), social function (SF), mental health (MH), and emotional role (RE). The mental health component summary score is calculated from the four scales of VT, SF, MH, and RE. Scores are constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score. Higher scores are associated with better quality of life.|Baseline and 9 weeks|Participants with evaluable data at both timepoints||T-score||Standard Deviation|Mean
742438|NCT00494507|Secondary|HOP Change From Baseline to Week 9 in SF-36 Physical Component Summary Score|The Medical Outcomes Study Short Form (SF-36) questionnaire is a widely used profile measure of generic health-related quality of life. The 36 questions are allocated to eight scales: physical function (PF), physical role (RP), bodily pain (BP), general health perceptions (GH), vitality (VT), social function (SF), mental health (MH), and emotional role (RE). The physical component summary score is calculated from the four scales of PF, RP, BP, and GH. Scores are constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score. Higher scores are associated with better quality of life.|Baseline and 9 weeks|Participants with evaluable data at both timepoints||T-score||Standard Deviation|Mean
742439|NCT00494507|Secondary|HYP Change From Baseline to Week 9 in SF-36 Physical Component Summary Score|The Medical Outcomes Study Short Form (SF-36) questionnaire is a widely used profile measure of generic health-related quality of life. The 36 questions are allocated to eight scales: physical function (PF), physical role (RP), bodily pain (BP), general health perceptions (GH), vitality (VT), social function (SF), mental health (MH), and emotional role (RE). The physical component summary score is calculated from the four scales of PF, RP,BP, and GH. Scores are constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score. Higher scores are associated with better quality of life.|Baseline and 9 weeks|Participants with evaluable data at both timepoints||T-score||Standard Deviation|Mean
742440|NCT00494507|Secondary|HOP Change From Baseline to Week 9 in Lean Body Mass|Lean body mass was measured by dual-energy X-ray absorptiometry (DEXA).|Baseline and 9 weeks|Participants who had lean body mass data available at baseline and week 9.||kg||Standard Deviation|Mean
742441|NCT00494507|Secondary|HYP Change From Baseline to Week 9 in Lean Body Mass|Lean body mass was measured by dual-energy X-ray absorptiometry (DEXA).|Baseline and 9 weeks|Participants who had lean body mass data available at baseline and week 9.||kg||Standard Deviation|Mean
742442|NCT00494507|Secondary|HOP Change From Baseline to Week 9 in Average Maximum Voluntary Isometric Contraction Testing Percent of Predicted Normal|"The strength of each of 10 muscles was measured using quantitative myometry and expressed as the percent of predicted normal given the participant's age, gender, and height. The scores were averaged across muscles to form a composite MVICT score: average percent of predicted normal score. A higher number indicates a better outcome.
The following muscles were tested: elbow extensor (left/right), elbow flexor (left/right), knee extensor (left/right), knee flexor (left/right), and hand grip (left/right)."|Baseline and 9 weeks|Participants with evaluable data at both timepoints||average percent of predicted normal||Standard Deviation|Mean
742443|NCT00494507|Secondary|HYP Change From Baseline to Week 9 in Average Maximum Voluntary Isometric Contraction Testing Percent of Predicted Normal|"The strength of each of 10 muscles was measured using quantitative myometry and expressed as the percent of predicted normal given the participant's age, gender, and height. The scores were averaged across muscles to form a composite MVICT score: average percent of predicted normal score. A higher number indicates a better outcome.
The following muscles were tested: elbow extensor (left/right), elbow flexor (left/right), knee extensor (left/right), knee flexor (left/right), and hand grip (left/right)."|Baseline and 9 weeks|Participants with evaluable data at both timepoints||average percent of predicted normal||Standard Deviation|Mean
742444|NCT00494507|Secondary|HOP Change From Baseline to Week 9 in Average Maximum Voluntary Isometric Contraction Testing (MVICT) Scores|"The strength of each of 10 muscles was measured using quantitative myometry and expressed as the number of standard deviations from normal (Z-score) given the participant's age, gender, and height. The scores were averaged across muscles to form a composite MVICT score: average standardized MVICT score. A positive Z-score indicates a better outcome.
The following muscles were tested: elbow extensor (left/right), elbow flexor (left/right), knee extensor (left/right), knee flexor (left/right), and hand grip (left/right)."|Baseline and 9 weeks|Participants with evaluable data at both timepoints||Z-score||Standard Deviation|Mean
742469|NCT00494780|Secondary|Number of Participants With Positive Human Anti-human Antibodies (HAHA) at Visits 1, 28, and 33|HAHA are indicators of immunogenicity to ofatumumab. Blood samples were drawn from participants at Visits 1, 28, and 33 for analysis of HAHA.|Visits 1 (Screening), 28 (9 months after last dose), and 33 (24 months after last dose)|FAS. Participants dropped out of the study as the study progressed.||participants|||Number
742445|NCT00494507|Secondary|HYP Change From Baseline to Week 9 in Average Maximum Voluntary Isometric Contraction Testing (MVICT) Scores|"The strength of each of 10 muscles was measured using quantitative myometry and expressed as the number of standard deviations from normal (Z-score) given the participant's age, gender, and height. The scores were averaged across muscles to form a composite MVICT score: average standardized MVICT score. A positive Z-score indicates a better outcome.
The following muscles were tested: elbow extensor (left/right), elbow flexor (left/right), knee extensor (left/right), knee flexor (left/right), and hand grip (left/right)."|Baseline and 9 weeks|Participants with evaluable data at both timepoints||Z-score||Standard Deviation|Mean
742446|NCT00494507|Secondary|HOP Change From Baseline to Week 9 in Average Manual Muscle Testing (MMT) Score|"The strength of each of 26 individual muscles was graded using a modified 13-point Medical Research Council scale ranging from 0-5. Recorded grades were converted to numerical values as follows prior to averaging across muscles to form a composite score: 0 = 0; 1 = 1; 2- = 1.67; 2 = 2; 2+ = 2.33; 3- = 2.67; 3 = 3; 3+ = 3.33; 4- = 3.67; 4 = 4; 4+ = 4.33; 5- = 4.67; 5 = 5. A higher score represents a better outcome, i.e. 5 = normal strength.
The following muscles were tested: shoulder abductor (left/right), elbow extensor (left/right), elbow flexor (left/right), wrist extensor (left/right), wrist flexor (left/right), hip flexor (left/right), hip extensor (left/right), hip abductor (left/right), knee extensor (left/right), knee flexor (left/right), ankle dorsiflexor (left/right), ankle plantar flexor (left/right), neck extensor, neck flexor."|Baseline and 9 weeks|Participants with evaluable data at both timepoints||units on a scale||Standard Deviation|Mean
742447|NCT00494507|Secondary|HYP Change From Baseline to Week 9 in Average Manual Muscle Testing (MMT) Score|"The strength of each of 26 individual muscles was graded using a modified 13-point Medical Research Council scale ranging from 0-5. Recorded grades were converted to numerical values as follows prior to averaging across muscles to form a composite score: 0 = 0; 1 = 1; 2- = 1.67; 2 = 2; 2+ = 2.33; 3- = 2.67; 3 = 3; 3+ = 3.33; 4- = 3.67; 4 = 4; 4+ = 4.33; 5- = 4.67; 5 = 5. A higher score represents a better outcome, i.e. 5 = normal strength.
The following muscles were tested: shoulder abductor (left/right), elbow extensor (left/right), elbow flexor (left/right), wrist extensor (left/right), wrist flexor (left/right), hip flexor (left/right), hip extensor (left/right), hip abductor (left/right), knee extensor (left/right), knee flexor (left/right), ankle dorsiflexor (left/right), ankle plantar flexor (left/right), neck extensor, neck flexor."|Baseline and 9 weeks|Participants with evaluable data at both timepoints||units on a scale||Standard Deviation|Mean
742448|NCT00494507|Secondary|HOP Endpoint of Acute Worsening|Increase in attack frequency or severity in HOP participants necessitating withdrawal from the initial nine-week double-blind treatment period and moving directly into the open-label phase.|0-9 weeks|||participants|||Number
742449|NCT00494507|Secondary|HYP Endpoint of Acute Worsening|Increase in attack frequency or severity in HYP participants necessitating withdrawal from the initial nine-week double-blind treatment period and moving directly into the open-label phase.|0-9 weeks|||participants|||Number
742450|NCT00494507|Secondary|HOP Attack Duration|HOP participant total attack duration per week, defined as the sum of attack durations across all distinct attacks over the final 8 weeks (Weeks 2-9) of the double-blind treatment period divided by the number of weeks that the subject was followed.|8 weeks|||hours per week||Inter-Quartile Range|Median
742451|NCT00494507|Secondary|HYP Attack Duration|HYP participant total attack duration per week, defined as the sum of attack durations across all distinct attacks over the final 8 weeks (Weeks 2-9) of the double-blind treatment period divided by the number of weeks that the subject was followed.|8 weeks|||hours per week||Inter-Quartile Range|Median
742452|NCT00494507|Secondary|HOP Severity-weighted Attack Rate|HOP participant severity-weighted attack rate is defined as the sum of average attack severity across all distinct attacks over the final 8 weeks (Weeks 2-9) of the double-blind treatment period divided by the number of weeks that the subject was followed. Attack severity (scored as 1-10 with increasing severity) is self-reported.|8 weeks|||severity-weighted attacks per week||Inter-Quartile Range|Median
742453|NCT00494507|Secondary|HYP Severity-weighted Attack Rate|HYP participant severity-weighted attack rate is defined as the sum of average attack severity across all distinct attacks over the final 8 weeks (Weeks 2-9) of the double-blind treatment period divided by the number of weeks that the subject was followed. Attack severity (scored as 1-10 with increasing severity) is self-reported.|8 weeks|||severity-weighted attacks per week||Inter-Quartile Range|Median
742454|NCT00494507|Primary|HOP Attack Rate|The number of distinct attacks per week over the final 8 weeks (Weeks 2-9) of the double-blind treatment period as self-reported by HOP participants.|8 weeks|||attacks per week||Inter-Quartile Range|Median
742455|NCT00494507|Primary|HYP Attack Rate|The number of distinct attacks per week over the final 8 weeks (Weeks 2-9) of the double-blind treatment period as self-reported by HYP participants.|8 weeks|||attacks per week||Inter-Quartile Range|Median
742456|NCT00494585|Primary|Number of Participants With Objective Response|Objective response = Complete Response, absence sign/symptoms of disease (without use of growth factors, hydroxyurea, anagrelide, or transfusions for > 1 month); Partial Response, absence of progressive disease (PD), and improvement in 2+ parameters (if abnormal): Absolute neutrophil count (ANC), hemoglobin, platelets, transfusions, splenomegaly, or bone marrow blasts; Clinical Improvement, absence of PD, and improvement in 1 parameter: ANC, hemoglobin, platelets, transfusions, splenomegaly, or bone marrow blasts). [International Working Group on Myelofibrosis Research and Treatment]|Response assessed after each 3 cycles (cycle = 30 days)|Intention to treat.||Participants|||Number
742457|NCT00494676|Secondary|Mobility Change Score (Only Participants Who Discontinued Prism Wear in the Long Term)|Perceived difficulties with mobility were quantified using a 5-point rating scale (no difficulty to extreme difficulty) for 7 situations (items) relevant to people with hemianopia, including at home, in stores, outdoors, in unfamiliar areas, in familiar areas, in crowded areas, and noticing objects off to the side when walking. The questionnaire was administered at baseline (without prisms) and after each period of the crossover. Interval scale measures of perceived difficulty with overall mobility for each participant were estimated using Rasch analysis of the responses to all seven items (Winsteps software, version 3.70.0.226). Rasch measures were expressed as logits (log odds ratios). Mobility improvement scores for real and sham prisms were defined as the difference in perceived difficulty relative to baseline (in logits).|Evaluated after 4 weeks of wearing each type of prism glasses|This is a subgroup analysis of the mobility change scores for real and sham prism glasses evaluated during the crossover. The subgroup includes only those participants who completed the crossover and then discontinued wearing prism glasses.||logits||Standard Deviation|Mean
742458|NCT00494676|Secondary|Mobility Change Score (Only Participants Who Continued Prism Wear in the Long Term)|Perceived difficulties with mobility were quantified using a 5-point rating scale (no difficulty to extreme difficulty) for 7 situations (items) relevant to people with hemianopia, including at home, in stores, outdoors, in unfamiliar areas, in familiar areas, in crowded areas, and noticing objects off to the side when walking. The questionnaire was administered at baseline (without prisms) and after each period of the crossover. Interval scale measures of perceived difficulty with overall mobility for each participant were estimated using Rasch analysis of the responses to all seven items (Winsteps software, version 3.70.0.226). Rasch measures were expressed as logits (log odds ratios). Mobility change scores for real and sham prisms were defined as the difference in perceived difficulty relative to baseline (in logits).|Evaluated after 4 weeks of wearing each type of prism glasses|This is a subgroup analysis of the mobility change scores for real and sham prism glasses evaluated during the crossover. The subgroup includes only those participants who completed the crossover and continued to wear prism glasses in the long term.||logits||Standard Deviation|Mean
742459|NCT00494676|Secondary|Mobility Change Score (All Participants Who Completed Crossover)|Perceived difficulties with mobility were quantified using a 5-point rating scale (no difficulty to extreme difficulty) for 7 situations (items) relevant to people with hemianopia, including at home, in stores, outdoors, in unfamiliar areas, in familiar areas, in crowded areas, and noticing objects off to the side when walking. The questionnaire was administered at baseline (without prisms) and after each period of the crossover. Interval scale measures of perceived difficulty with overall mobility for each participant were estimated using Rasch analysis of the responses to all seven items (Winsteps software, version 3.70.0.226). Rasch measures were expressed as logits (log odds ratios). Mobility change scores for real and sham prisms were defined as the difference in perceived difficulty relative to baseline (in logits).|Evaluated after 4 weeks of wearing each type of prism glasses|Only participants who completed the crossover were included in this analysis||logits||Standard Deviation|Mean
742460|NCT00494676|Primary|"Overall Proportion Saying Yes to Real Prism Glasses"|"At the end of each crossover period, participants were asked a yes/no question: If the study were to end today, would you want to continue with these prism glasses (i.e. the prism glasses worn in that period)? The primary outcome was the overall difference, across the two periods of the crossover, between the proportion of participants saying yes to real prism glasses and the proportion saying yes to sham prism glasses."|Evaluated after 4 weeks of wearing each type of prism glasses|Only participants who completed the crossover were included in this analysis||participants|||Number
742461|NCT00494780|Secondary|Vss at the Sixth Infusion (Week 15, Visit 22)|Vss is defined as the volume of distribution at steady state of ofatumumab.|Week 15 (Visit 22)|FAS. Data were provided for the number of participants attending each visit for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed.||Liters||Geometric Coefficient of Variation|Geometric Mean
742462|NCT00494780|Secondary|CL After the Sixth Infusion (Week 15, Visit 22)|CL is the clearance of drug from plasma, which is defined as the volume of plasma from which the drug is cleared per unit time.|Week 15 (Visit 22)|FAS. Data were provided for the number of participants attending each visit for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed.||Milliliters per hour (mL/h)||Geometric Coefficient of Variation|Geometric Mean
742463|NCT00494780|Secondary|Half Life (t1/2) of Ofatumumab at the Sixth Infusion (Week 15, Visit 22)|Half life is defined as the period of time required for the amount of drug in the body to be reduced by half.|Week 15 (Visit 22)|FAS. Data were provided for the number of participants attending each visit for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed.||hours||Geometric Coefficient of Variation|Geometric Mean
742464|NCT00494780|Secondary|AUC(0-inf) and AUC(0-504) After the Sixth Infusion (Week 15, Visit 22)|AUC is defined as the area under the ofatumumab concentration-time curve as a measure of drug exposure. AUC(0-504) is AUC from the start of infusion to 504 hours after the start of the infusion; AUC(0-inf) is AUC from the start of infusion extrapolated to infinity.|Week 15 (Visit 22)|FAS. Data were provided for the number of participants for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed.||Milligrams * hours/liter (mg.h/L)||Geometric Coefficient of Variation|Geometric Mean
742465|NCT00494780|Secondary|Cmax and Ctrough at the Sixth Infusion (Week 15, Visit 22)|Cmax is defined as the maximum concentration of drug in plasma samples. Ctrough is defined as the trough plasma concentration (measured concentration at the end of a dosing interval [taken directly before next administration]).|Week 15 (Visit 22)|FAS. Data were provided for the number of participants who had a value. Participants withdrawn during the study were not analyzed.||milligrams per liter (mg/L)||Geometric Coefficient of Variation|Geometric Mean
742466|NCT00494780|Secondary|Number of Participants Who Had a Conversion of BCL-2 t(14;18)-Positive to Negative by Polymerase Chain Reaction (PCR) in Peripheral Blood and Bone Marrow Aspirate and Its Durability Post-therapy|This is a genetic prognostic marker of FL response. The former sponsor decided to not analyze these samples; therefore, no results are presented.|Maximum of 6 years follow-up|FAS|||||
742467|NCT00494780|Primary|Number of Participants With the Indicated Overall Best Response (OBR) at Visit 26 (3 Months After the Last Infusion of Ofatumumab)|Based on standardized response criteria for NHL, responders included participants with CR (complete disappearance of all detectable clinical and radiographic evidence of disease), CRu (more than a 75% decrease in LN size compared to baseline), and PR (>=50% decrease in LN size and evidence of new lesions). Non-responders included participants with stable disease (SD; <50% decrease in LN size from baseline) and progressive disease (PD; >=50% increase in LN size and evidence of new lesions).|Maximum of 23 months after the start of treatment|FAS||participants|||Number
742468|NCT00494780|Secondary|Median Percent Change From Visit 1 (Screening) in Serum Complement (CH50) Levels at Visit 22|The peripheral blood for each participant was collected and analyzed for serum complement CH50 levels. Cluster of Differentiation index 50 (CD50) is a human gene which is used as an index of immune response. CD50Percent change from Visit 1 (Screening, Week -2) = (value at Visit 22 minus value at Visit 1 divided by value at Visit 1) * 100.|Visit 1 (Screening, Week -2) and Visit 22 (Week 15)|FAS. Only those participants who remained in the study at Visit 22 were analyzed.||Percent change in serum complement CH50||Full Range|Median
743559|NCT00486330|Primary|Area Under the Curve of BUP/NLX With TPV/r (h*ng/mL)|Non-compartmental methods were used for pharmacokinetic analysis. The area under the plasma drug concentration-time curve was estimated by linear-log trapezoidal rule at 24-hrs.|10 days|||h*ng/mL||Full Range|Geometric Mean
742470|NCT00494780|Secondary|Number of Participants Who Experienced Any Adverse Event (AEs) From First Treatment to Visit 33 (24 Months After Last Infusion)|An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with the treatment. A list of AEs experienced in the study with a frequency threshold of 5% can be found in the AE section.|Up to 22 months after study start|FAS||participants|||Number
742471|NCT00494780|Secondary|Percent Change From Visit 1 (Screening) in Peripheral CD19+ and CD20+ Cell Counts at Visit 33 (24 Months After the Last Infusion of Ofatumumab)|The peripheral blood for each participant was collected and analyzed for CD19+ and CD20+ cell counts. CD19+ and CD20+ are B-cell types which are used as an index of a participant's response to treatment.|Maximum of 24 months after the last infusion of Ofatumumab (Visit 33; median of 33.8 months)|FAS. Only those participants who provided samples at Visit 33 were analyzed.||Percent change in cell counts||Full Range|Median
742472|NCT00494780|Secondary|Duration of Response|The duration of response is defined as the time from the initial response (the first visit at which response was observed) to progression or death.|Followed up to 5 years|FAS. Only those participants with a response were analyzed.||months||95% Confidence Interval|Median
742473|NCT00494780|Secondary|Progression-Free Survival (PFS)|PFS is defined as the time from randomization until progression or death.|Followed up to 5 years|FAS||months||95% Confidence Interval|Median
742474|NCT00494780|Secondary|Time to New Anti-follicular Lymphoma (FL) Therapy|Time to new FL therapy is defined as the time from randomization until the time of first administration of the new FL therapy other than ofatumumab. Time to new FL therapy will be censored if participants are lost to follow-up. The censoring date in such cases will be the date of the last attended visit at which the endpoint was assessed.|Followed up to 5 years|FAS||months||95% Confidence Interval|Median
742475|NCT00494780|Secondary|Median Percent Change From Visit 1 (Screening, Week -2) in Tumor Size at Visit 33 (24 Months After the Last Infusion of Ofatumumab)|The tumor size for a participant was computed as the sum of product of diameters (SPD) for the indicator lesions. Reduction in tumor size was calculated as percent change from Visit 1 until Visit 33, separately by radiologist 1 and radiologist 2. Percent change from Visit 1 (Screening, Week -2) = (value at Visit 33 minus value at Visit 1 divided by value at Visit 1) * 100.|Maximum of 24 months after the last infusion of Ofatumumab (Visit 33; median of 33.8 months)|FAS. Participants were withdrawn from the study between Visits 1 and 33.||Percent change in tumor size||Full Range|Median
742476|NCT00494780|Secondary|Number of Participants With Complete Remission (CR) at Visit 26|Participants were evaluated for response by an Independent Endpoint Review Committee in accordance with the standardized response criteria for NHL. Participants with CR were defined as those with the complete disappearance of all detectable clinical and radiographic evidence of disease.|Maximum of 23 months after the start of treatment|FAS||participants|||Number
742477|NCT00494806|Primary|Time to First Postoperative Flatus in Days Was the End of Postoperative Ileus (POI) Indicator.|Time from end of surgical procedure until passage of first postoperative flatus was used as an indicator for resolution of postoperatve ileus (POI).|Daily from first day after surgical procedure to passage of first flatus (up to 5 - 7 days post surgery).|Intention to treat (ITT) method was used.||Days||Standard Deviation|Mean
742478|NCT00494871|Secondary|Event Rate Adjudicated Non-major Clinically Relevant Bleeding|All events were adjudicated and confirmed by a central independent committee blinded to treatment. Non-major clinically relevant bleeding was clinically overt bleeding that does not meet the definition of major bleeding, but requires medical intervention or unscheduled contact with the physician, (temporary) discontinuation of the study treatment, discomfort to the subject such as pain, or impairment of activities of daily life.|Up to 2 days after the last dose|The safety analysis population consisted of randomized participants who took at least one dose of study treatment (639 in each treatment group).||Events per 100 patient-years|||Number
742479|NCT00494871|Secondary|Event Rate of Adjudicated Major Bleeding|All events were adjudicated and confirmed by a central independent committee blinded to treatment. Major bleeding was clinically overt bleeding associated with a fall in hemoglobin of 2 g/dL or higher, leading to a transfusion of 2 or more units of packed red blood cells or whole blood, occurring in a critical site or contributing to death.|Up to 2 days after the last dose|The safety analysis population consisted of randomized participants who took at least one dose of study treatment (639 in each treatment group).||Events per 100 patient-years|||Number
742480|NCT00494871|Secondary|Event Rate of All-cause Death|All events were adjudicated and confirmed by a central independent committee blinded to treatment. All-cause death included vascular death and non-vascular death.|Up to 2 days after the last dose|The per-protocol analysis population consisted of randomized participants excluding those who had specific pre-defined major protocol deviations (637 in each treatment group).||Events per 100 patient-years|||Number
742481|NCT00494871|Secondary|Event Rate of Stroke With Serious Residual Disability|All events were adjudicated and confirmed by a central independent committee blinded to treatment. A stroke was considered disabling if the participant’s modified Rankin score was between 3 and 5, inclusive.|Up to 2 days after the last dose|The per-protocol analysis population consisted of randomized participants excluding those who had specific pre-defined major protocol deviations (637 in each treatment group).||Events per 100 patient-years|||Number
742482|NCT00494871|Secondary|Event Rate of Vascular Death|All events were adjudicated and confirmed by a central independent committee blinded to treatment. Any death that was not clearly non-vascular (e.g., deaths due to spontaneous bleeding, myocardial infarction, stroke, cardiac failure, and arrhythmia)|Up to 2 days after the last dose|The per-protocol analysis population consisted of randomized participants excluding those who had specific pre-defined major protocol deviations (637 in each treatment group).||Events per 100 patient-years|||Number
742483|NCT00494871|Secondary|Event Rate of Myocardial Infarction|All events were adjudicated and confirmed by a central independent committee blinded to treatment. Myocardial infarction was assessed based on either cardiac bio-markers (troponin I, troponin T, or creatine kinase-muscle and brain subunit isozyme), new abnormal Q waves appeared on ECG for 2 or more leads, or autopsy confirmation.|Up to 2 days after the last dose|The per-protocol analysis population consisted of randomized participants excluding those who had specific pre-defined major protocol deviations (637 in each treatment group).||Events per 100 patient-years|||Number
744125|NCT00506662|Secondary|Change in Mean Fasting Plasma Glucose (FPG) at Month 7||week 0, month 7|Due to the recruitment issue, the trial has been prematurely interrupted and the final number of patients does not allow any efficacy analysis.|||||
742484|NCT00494871|Secondary|Event Rate of Non-CNS Systemic Embolism|"All events were adjudicated and confirmed by a central independent committee blinded to treatment. Non-CNS systemic embolism was abrupt vascular insufficiency associated with clinical or radiological evidence of arterial occlusion in the absence of other likely mechanisms (such as trauma, atherosclerosis, and instrumentation). Arterial emboli in the following areas were non-CNS systemic embolism”: peripheral arterial in the upper and lower extremities, renal, mesenteric, splenic, hepatic, ocular/retinal and others. Pulmonary embolism or myocardial infarction was excluded from this category."|Up to 2 days after the last dose|The per-protocol analysis population consisted of randomized participants excluding those who had specific pre-defined major protocol deviations (637 in each treatment group).||Events per 100 patient-years|||Number
742485|NCT00494871|Secondary|Event Rate of Stroke|All events were adjudicated and confirmed by a central independent committee blinded to treatment. Stroke included hemorrhagic (Stroke with local collections of intraparenchymal blood. Subarachnoid hemorrhage, subdural hemorrhage, and epidural hemorrhage were excluded.), ischemic infarction (Stroke without focal collection of intracranial blood) and unknown (No imaging data and anatomic findings were available.).|Up to 2 days after the last dose|The per-protocol analysis population consisted of randomized participants excluding those who had specific pre-defined major protocol deviations (637 in each treatment group).||Events per 100 patient-years|||Number
742486|NCT00494871|Secondary|Event Rate of the Composite Endpoint of Adjudicated Stroke, Non-CNS Systemic Embolism, Myocardial Infarction, and Vascular Death|"Stroke included hemorrhagic, ischemic infarction and unknown. Arterial emboli in the following areas were non-CNS systemic embolism”: peripheral arterial in the upper and lower extremities, renal, mesenteric, splenic, hepatic, ocular/retinal and others. Pulmonary embolism or myocardial infarction was excluded. Myocardial infarction: assessed based on either cardiac biomarkers, new abnormal Q waves appeared on electrocardiogram for ≥2 leads, or autopsy confirmation. Any death that was not clearly non-vascular."|Up to 2 days after the last dose|The per-protocol analysis population consisted of randomized participants excluding those who had specific pre-defined major protocol deviations (637 in each treatment group).||Events per 100 patient-years|||Number
742487|NCT00494871|Secondary|Event Rate of the Composite Endpoint of Adjudicated Stroke, Non-CNS Systemic Embolism, and Vascular Death|"Stroke included hemorrhagic, ischemic infarction and unknown. Arterial emboli in the following areas were non-CNS systemic embolism”: peripheral arterial in the upper and lower extremities, renal, mesenteric, splenic, hepatic, ocular/retinal and others. Pulmonary embolism or myocardial infarction was excluded. Any death that was not clearly non-vascular."|Up to 2 days after the last dose|The per-protocol analysis population consisted of randomized participants excluding those who had specific pre-defined major protocol deviations (637 in each treatment group).||Events per 100 patient-years|||Number
742488|NCT00494871|Secondary|Event Rate of the Composite Endpoint of Adjudicated Stroke and Non-central Nervous System (CNS) Systemic Embolism|"This is the principal efficacy endpoint. Stroke included hemorrhagic, ischemic infarction and unknown. Arterial emboli in the following areas were non-CNS systemic embolism”: peripheral arterial in the upper and lower extremities, renal, mesenteric, splenic, hepatic, ocular/retinal and others. Pulmonary embolism or myocardial infarction was excluded."|Up to 2 days after the last dose|The per-protocol analysis population consisted of randomized participants excluding those who had specific pre-defined major protocol deviations (637 in each treatment group).||Events per 100 patient-years|||Number
742489|NCT00494871|Primary|Event Rate of the Composite Endpoint of Adjudicated Major Bleeding or Adjudicated Non-major Clinically Relevant Bleeding|Major bleeding: clinically overt bleeding (COB) associated with a fall in hemoglobin ≥2 g/dL, leading to transfusion ≥2 units of packed red blood cells or whole blood, occurring in a critical site or contributing to death. Non-major clinically relevant bleeding: COB that does not meet the definition of major bleeding, but requires medical intervention or unscheduled contact with the physician, (temporary) discontinuation of the study treatment, discomfort to the subject such as pain, or impairment of activities of daily life.|Up to 2 days after the last dose|The safety analysis population consisted of randomized participants who took at least one dose of study treatment (639 in each treatment group).||Events per 100 patient-years|||Number
742490|NCT00494975|Secondary|Detailed Questionnaire at Baseline and After 18 Sessions||at baseline and after 18 sessions||||||
742491|NCT00494975|Primary|Visual Analogue Scale (VAS) Score for Pruritus|"a VAS is a horizontal line, 100 mm in length. The patient marks on the line the point that they feel represents their perception of their pruritus.
0 (no pruritus) - 10 (most severe pruritus) The investigator will determine the pruritic intensity at baseline, every 3 sessions by VAS score, and by detailed questionnaire at baseline and after 18 sessions"|VAS score at baseline and after 6 -week phototherapy|||Units on a scale||Standard Deviation|Mean
742492|NCT00495079|Primary|Clinical Response Assessment Per Independent Response Review Committee (IRRC) Evaluation|Number of subjects who achieved Complete Remission (CR)as assessed by the IRRC. CR is defined as no evidence of ALL. ANC>=1X10^9/L or Platelet count>=100x10^9/L, absence of blasts in blood and morrow (<5%), resolution of all sites of extramedullary disease (EMD). CR with incomplete blood count recovery(CRi)is defined as per CR but platelet count <100x10^9/L or ANC<1x10^9/L.|Response assessment at the end of each 28 days course|The IRRC evaluable population included all subjects who received at least 1 dose of study drug and who has reviewable data to assess and determine response or lack of response as determined by the IRRC.||participants|||Number
742493|NCT00495079|Secondary|Overall Survival|Time, in days, from informed consent date until the date of death or date of last contact|unlimited|Based on the first date of CR or CRi to date of documented relapse, death, or subsequent chemotherapies including hematopoietic stem cell transplant (HSCT)(n=10)||days||95% Confidence Interval|Median
742494|NCT00495079|Secondary|Duration of CR + CRi|Duration of response for those subjects who achieved CR or CRi|CR + CRi duration was calculated from the date the subject first met the definition of CR or CRi until the date of relapse|Based on the first date of CR or CRi to the date of the last available histologic assessment of the same response (n=8)||days||95% Confidence Interval|Median
742551|NCT00483756|Secondary|Number of Participants With Graft Loss|Graft loss was defined as graft nephrectomy, participant death, re-transplantation, or return to dialysis for >=6 consecutive weeks.|Month 6, 12|FAS with last dosing risk set: all randomized participants who received at least 1 dose of study medication, including events occurring up to 7 days after last dose. Here, N (Number of Participants Analyzed): participants evaluable for this measure; and n: participants who remained at risk at given time point for each group, respectively.||participants|||Number
742495|NCT00495079|Primary|Complete Remission Plus Complete Remission Without Full Platelet Recovery (CR + CRi)|CR is defined as no evidence of ALL: ANC>or=1x10^9/L or platelet count>100x10^9/L, absence of leukemia blast cells in blood and marrow (<5% blasts), resolution of all sites of extramedullary disease (EMD). CR with incomplete blood count recovery (CRi): As per CR but platelet count< 100x10^9/L or ANC< 1x10^9/L. Partial remission(PR):CR with>5-25% abnormal cells in the marrow or 50% decrease in bone marrow blasts. Reduction in EMD by at least 50%. Hematologic Improvement. Bone marrow blast(BMB) response: BMB<5% in the absence of HI. Stable disease(SD):No significant hematological and extramedullary change from baseline.|Response assessment performed at the end of each 28 day course.|Subjects who had CR plus CRi by the PI and the IRRC assessments using the International Working Group Criteria. The Intent-to-Treat Analysis, n=65, minimum 1 dose. The IRRC, n=53, 1 dose, assess response as determined by the IRRC. Analyses, a Simon’s 2-stage minimax design where the type I error alpha was set at 0.10 and the power was 80%.||participants|||Number
742496|NCT00495131|Secondary|Histologic Response|Histologic response: improvement of at least 2 grade of scores by Ishak liver histologic classification by end of follow up liver biopsy to baseline liver biopsy|18 months|Data included for analysis only for patients with paired liver biopsies.||Participants|||Number
742497|NCT00495131|Primary|Sustained Biochemical Response|Sustained biochemical response (SBR): alanine aminotransferase (ALT) normalization|18 months|Patients with end of follow-up alanine aminotransferase (ALT) levels||Participants|||Number
742498|NCT00495131|Primary|Sustained Virologic Response|Undetectable HCV RNA 6 months off therapy|18 months|Intention-to-treat (ITT) analysis by last observation carried forward||participants|||Number
742499|NCT00495131|Secondary|Treatment-related Withdrawal Rate|Treatment-related withdrawal rate: patients who prematurely discontinued treatment due to treatment-related adverse events|18 months|||Participants|||Number
742500|NCT00495157|Secondary|Adverse Events||Measured during the 36-week treatment period||||||
742501|NCT00495157|Secondary|Total Amount of Oral Prednisone Required and Total Amount of Inhaled Steroids||Measured during the 36-week treatment period||||||
742502|NCT00495157|Secondary|Quality-of-life (AQLQ), Asthma Control Questionnaire (ACQ), and Number of Visit Days That ACQ is Less Than 1.25||Measured during the 36-week treatment period||||||
742503|NCT00495157|Secondary|Tests of Airway Inflammation (Exhaled Breath Condensate (EBC), Fractional Exhaled Nitric Oxide (FeNO), Sputum Eosinophils)||Measured during the 36-week treatment period||||||
742504|NCT00495157|Secondary|Tests of Airway Caliber and Responsiveness (Forced Expiratory Volume in One Second (FEV1) Pre- and Post-bronchodilator Inhalation), Methacholine Provocative Concentration at 20% (PC20)||Measured during the 36-week treatment period||||||
742505|NCT00495157|Secondary|Number of Asthma Exacerbations||Measured during the 36-week treatment period||||||
742506|NCT00495157|Secondary|Time to First Asthma Exacerbation||Measured during the 36-week treatment period||||||
742507|NCT00495157|Secondary|Number of Episodes of Treatment Failure||Measured during the 36-week treatment period||||||
742508|NCT00495157|Primary|Time to Treatment Failure (Measured in Days)||Measured during the 36-week treatment period|All participants were followed for time to treatment failure or right censoring (measured in days).||days||Standard Error|Mean
742509|NCT00495222|Primary|Knotting Elements Placed|completion of plication (1-3 knotting elements placed per procedure)|intra-operative|Intent to Treat||elements|||Number
742510|NCT00495391|Secondary|Changes in ALT|This analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up.|From baseline to end of follow up|||participants|||Number
742511|NCT00495391|Secondary|Changes in ALT|This analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up.|From baseline to end of treatment|||participants|||Number
742512|NCT00495391|Secondary|Changes in ALT|This analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up.|From baseline to week 16|||participants|||Number
742513|NCT00495391|Secondary|Changes in ALT|This analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up.|From baseline to week 8|||participants|||Number
742514|NCT00495391|Secondary|Rapid Virologic Response (HCV RNA Below Lower Limit of Detection)|Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection after 4 weeks of combination therapy.|After 4 weeks combination treatment|||participants|||Number
742515|NCT00495391|Secondary|Early Virologic Response (HCV RNA Below Lower Limit of Detection)|Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection after 12 weeks of combination therapy.|After 12 weeks combination treatment|||participants|||Number
742516|NCT00495391|Secondary|End of Treatment Response (HCV RNA Below Lower Limit of Detection)|Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection at the end of treatment. All others were considered non-responders.|At end of treatment|||participants|||Number
742517|NCT00495391|Primary|Sustained Virologic Response (HCV RNA Below Lower Limit of Detection)|Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection 24 weeks after the end of treatment. All others were considered non-responders.|24 weeks after end of treatment|||participants|||Number
742518|NCT00483704|Secondary|Percentage of Participants Reporting Total Migraine Freedom From 2 to 24 Hours Post-dose (First Migraine Attack)|TMF from 2 to 24 hours post-dose, which is defined as TMF at 2 hours post-dose, with no administration of either rescue medication or the optional second dose and with no occurrence thereafter of a mild/moderate/severe headache and no reported occurrence of photophobia, phonophobia, nausea, or vomiting during the 2 to 24 hours after dosing with the study medication.|From 2 to 24 hours post-dose for the first migraine attack (up to 6 months)|The FAS Population included participants treated that migraine attack, and had both a baseline value and at least 1 post-dose efficacy measurement for pain severity prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline pain score or post-dose data through 24 hours.||Percentage of participants|||Number
742796|NCT00487240|Secondary|Percentage of Patients With Hemoglobin A1c (HbA1c) Less Than or Equal to 7.0% and HbA1c Less Than or Equal to 6.5%||32 Weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.||percentage of participants|||Number
742519|NCT00483704|Secondary|Percentage of Participants Reporting Total Migraine Freedom at 2 Hours Post-dose (First Migraine Attack)|TMF 2 hours post-dose, which is defined as TMF at 2 hours post-dose, with no administration of either rescue medication or the optional second dose and with no occurrence thereafter of a mild/moderate/severe headache and no reported occurrence of photophobia, phonophobia, nausea, or vomiting during the 2 hours after dosing with the study medication.|2 hours post-dose for the first migraine attack (up to 6 months)|The FAS Population included participants treated that migraine attack, and had both a baseline value and at least 1 post-dose efficacy measurement for pain severity prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline pain score or post-dose data through 2 hours.||Percentage of participants|||Number
742520|NCT00483704|Secondary|Percentage of Participants Reporting Sustained Pain Freedom From 2 to 48 Hours Post-dose (First Migraine Attack)|Sustained Pain Freedom (SPF) from 2 to 48 hours post-dose after study medication administration. SPF from 2 to 48 hours post-dose is defined as PF at 2 hours, with no administration of either rescue medication or the optional second dose and with no occurrence thereafter of a mild/moderate/severe headache during the 2 to 48 hours after dosing with the study medication.|From 2 to 48 hours post-dose for the first migraine attack (up to 6 months)|The FAS Population was participants treated that migraine attack, and had both a baseline value and at least 1 post-dose efficacy measurement for pain severity prior to, or including, the 2-hr. time point. Participants were excluded from this analysis for not having a baseline pain score, post-dose data through 48 hrs, or a recurrence question.||Percentage of participants|||Number
742521|NCT00483704|Secondary|Percentage of Participants Reporting Sustained Pain Freedom From 2 to 24 Hours Post-dose (First Migraine Attack)|Sustained Pain Freedom (SPF) from 2 to 24 hours after study medication administration. SPF from 2 to 24 hours post-dose is defined as PF at 2 hours, with no administration of either rescue medication or the optional second dose and with no occurrence thereafter of a mild/moderate/severe headache during the 2 to 24 hours after dosing with the study medication.|From 2 to 24 hours post-dose for the first migraine attack (up to 6 months)|The FAS Population was participants treated that migraine attack, and had both a baseline value and at least 1 post-dose efficacy measurement for pain severity prior to, or including, the 2-hr. time point. Participants were excluded from this analysis for not having a baseline pain score, post-dose data through 24 hrs, or a recurrence question.||Percentage of participants|||Number
742522|NCT00483704|Primary|Number of Participants Discontinuing Study Medication Due to an AE|Participants discontinuing study medication due to an AE were reported for all migraine attacks.|Up to the 4th dose of study medication (up to 6 months)|The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.||Participants|||Number
742523|NCT00483704|Primary|Number of Participants Experiencing an Adverse Event (AE) Within 48 Hours Post-dose (First Migraine Attack)|AEs were reported following treatment for the first migraine attack using a 48-hour post-dose window. AEs displayed are those reported by at least 4 participants in one or more treatment groups.|Up to 48 hours post-dose for the first migraine attack (up to 6 months)|The All-Patients-as-Treated (APaT) Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication for the first migraine attack, they were included in that treatment group.||Participants|||Number
742524|NCT00483704|Primary|Percentage of Participants Reporting Absence of Nausea 2 Hours Post-dose (First Migraine Attack)|The participant recorded whether nausea was present or absent at each of the predefined time points.|2 hours post-dose for the first migraine attack (up to 6 months)|The FAS Population included participants treated that migraine attack, and had both a baseline value and at least 1 post-dose measurement for nausea severity prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline nausea score or post-dose data through 2 hours.||Percentage of participants|||Number
742525|NCT00483704|Primary|Percentage of Participants Reporting Absence of Phonophobia at 2 Hours Post-dose (First Migraine Attack)|The participant recorded whether phonophobia (sensitivity to sound) was present or absent at each of the predefined time points.|2 hours post-dose for the first migraine attack (up to 6 months)|The FAS Population included participants treated that migraine attack, and had both a baseline value and at least 1 post-dose phonophobia measurement prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline phonophobia score or post-dose data through 2 hours.||Percentage of participants|||Number
742526|NCT00483704|Primary|Percentage of Participants Reporting Absence of Photophobia at 2 Hours Post-dose (First Migraine Attack)|The participant recorded whether photophobia (sensitivity to light) was present or absent at each of the predefined time points.|2 hours post-dose for the first migraine attack (up to 6 months)|The FAS Population included participants treated that migraine attack, and had both a baseline value and at least 1 post-dose measurement for photophobia severity prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline photophobia score or post-dose data through 2 hours.||Percentage of participants|||Number
742527|NCT00483704|Primary|Percentage of Participants Reporting Pain Relief Consistency at 2 Hours Post-dose|Pain Relief Consistency (PRC) at 2 hours post-dose, defined as having achieved PR at 2 hours post-dose on at least 3 treated migraine attacks. Note that for the control groups, a positive PR response arising from the administration of the 1 telcagepant treated migraine attack will count as one of the 3 positive PR responses needed to fulfill the criteria for PRC.|2 hours post-dose (up to 6 months)|The MFAS Population was defined as all participants who experienced at least either 2 failures or 3 successes, regardless of whether or not they had data for 4 migraine attacks, and recorded baseline severity for at least 1 of the treated migraine attacks.||Percentage of participants|||Number
742574|NCT00484185|Secondary|Average Infusion Dose of Study Medication|Average of dose per infusion per kilogram (kg) body weight was reported for prophylaxis purpose or on-demand therapy and surgery.|Baseline up to 6 months|Efficacy analysis set included all participants who received at least 1 dose of study medication for the approved indications and were evaluated upon its related parameters at least once. Here 'N' (number of participants analyzed)= participants evaluable for this measure and 'n' = participants evaluable for the specified category.||international unit/kilogram (IU/kg)||Standard Deviation|Mean
748846|NCT00538642|Secondary|Abdominal Circumference||4-5 months|||cm||Standard Deviation|Mean
742528|NCT00483704|Primary|Percentage of Participants Reporting Pain Freedom Consistency at 2 Hours Post-dose|Pain Freedom Consistency (PFC) at 2 hours post-dose, defined as having achieved PF at 2 hours post-dose on at least 3 treated migraine attacks. Note that for the control groups, a positive PF response arising from the administration of the 1 talcagepant treated migraine attack will count as one of the 3 positive PF responses needed to fulfill the criteria for PFC.|2 hours post-dose (up to 6 months)|The modified FAS (MFAS) Population consisted of all participants who experienced at least either 2 failures or 3 successes, regardless of whether or not they had data for 4 migraine attacks, and recorded baseline severity for at least 1 of the treated migraine attacks.||Percentage of participants|||Number
742529|NCT00483704|Primary|Percentage of Participants Reporting Pain Relief at 2 Hours Post-dose (First Migraine Attack)|Pain Relief (PR) at 2 hours post-dose (first migraine attack), with pain relief defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 1/0 at 2 hours post-dose. Headache severity was subjectively rated by the participant at predefined time points on a scale of Grade 0 to Grade 3: Grade 0 - No pain; Grade 1 - Mild pain; Grade 2 - Moderate Pain; and Grade 3 - Severe Pain.|2 hours post-dose for the first migraine attack (up to 6 months)|The FAS Population included participants treated that migraine attack, and had both a baseline value and at least 1 post-dose efficacy measurement for pain severity prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline pain score or post-dose data through 2 hours.||Percentage of participants|||Number
742530|NCT00483704|Primary|Percentage of Participants Reporting Pain Freedom at 2 Hours Post-dose (First Migraine Attack)|Pain Freedom (PF) at 2 hours post-dose (first migraine attack), with pain freedom defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 0 at 2 hours post-dose. Headache severity was subjectively rated by the participant at predefined time points on a scale of Grade 0 to Grade 3: Grade 0 - No pain; Grade 1 - Mild pain; Grade 2 - Moderate Pain; and Grade 3 - Severe Pain.|2 hours post-dose for the first migraine attack (up to 6 months)|The full-analysis set (FAS) included participants treated that migraine attack, and had both a baseline value and at least 1 post-dose efficacy measurement for pain severity prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline pain score or post-dose data through 2 hours.||Percentage of participants|||Number
742531|NCT00483717|Secondary|The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point|Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain|48 hours post-dosing|Modified ITT||participants|||Number
742532|NCT00483717|Secondary|The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point|Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain|24 hours post-dosing|Modified ITT||participants|||Number
742533|NCT00483717|Secondary|The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point|Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain|4 hours post-dosing|Modified ITT||participants|||Number
742534|NCT00483717|Secondary|The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point|Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain|3 hours post-dosing|Modified ITT||participants|||Number
742535|NCT00483717|Secondary|The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point|Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain|1.5 hours post-dosing|Modified ITT||participants|||Number
742536|NCT00483717|Secondary|The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point|Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain|1 hour post-dosing|Modified ITT||participants|||Number
742537|NCT00483717|Secondary|The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point|Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain|0.5 hours post-dosing|Modified ITT||participants|||Number
742538|NCT00483717|Primary|The Number of Treated Subjects Who Became Pain-free (International Headache Society Grade of 0 = no Pain) by Observation Time Point.|Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain|2 hours after dosing|Modified ITT||participants|||Number
742539|NCT00483756|Secondary|Severity of Dyspepsia Assessment (SODA)|SODA:17-item health scale, assessed participant-reported perceptions of dyspepsia;consists of 3 subscales:Pain Intensity (6-items to assess pain and intensity of abdominal [Ab] discomfort; Range (Ra):2-47, higher score= greater pain and Ab discomfort), Non-Pain Symptoms (7-items to assess severity and impact of non-pain symptoms:burping/belching,heartburn,bloating,flatulence,sour taste,nausea,and bad breath; Ra:7-35,higher scores = increased symptom severity and influence), and Satisfaction (4-items to assess degree of satisfaction with Ab discomfort; Ra:2-23,higher scores= more satisfaction).|Baseline, Month 6, 12|Data not analyzed since the SODA instrument was found irrelevant in the treated population.|||||
742540|NCT00483756|Secondary|End-Stage Renal Disease Symptom Checklist Transplantation Module (ESRD-SCL)|ESRD-SCL:43-item disease specific self-administered questionnaire. Participants’ rated question“At the moment,how much do you suffer?”for each item on 5 point scale,ranged (Ra) 0(not at all)to 4(extremely).Consisted of 6 subscales:cardiac and renal dysfunction;Ra 0-28,increased(In) growth of gum and hair;Ra 0-20,limited cognitive capacity;Ra 0-32,limited physical capacity;Ra 0 - 40,side effects (SEs) of corticosteroids;Ra 0-20,transplantation associated psychological distress(TAPD);Ra 0-32(higher scores=greater dysfunction for each subscale).Total score:0-172,higher scores=greater dysfunction.|Baseline, Month 6, 12|FAS: all randomized participants who received at least 1 dose of study medication. Here, N (Number of Participants Analyzed) signifies participants evaluable for this measure; and 'n' signifies those participants who were evaluable at given time point for each group, respectively.||units on a scale||Standard Deviation|Mean
742645|NCT00485069|Secondary|Percentage of Participants Remaining in the Study on the Indicated Days in the ROP+L-Dopa Group|The percentage of participants remaining in the study was presented by Kaplan-Meier method, where premature discontinuation (i.e., withdrawal before Week 52) was the event, and participants who had completed the study were censored.|Days 0-422|FAS||percentage of participants|||Number
742541|NCT00483756|Secondary|36-Item Short-Form Health Survey (SF-36)|SF-36: standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical and mental component scores. Total of 11 variables were analyzed (8 subscales,2 composite subscales and Question(Q) 2 “how would you rate your health in general now?”(range 1=better, 5=worst). The score for a section (except Q2) is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline, Month 6, 12|FAS: all randomized participants who received at least 1 dose of study medication. Here, N (Number of Participants Analyzed) signifies participants evaluable for this measure; and 'n' signifies those participants who were evaluable at given time point for each group, respectively.||units on a scale||Standard Deviation|Mean
742542|NCT00483756|Secondary|Number of Participants With Clinically Significant Infections|Clinically significant infection was defined as the presence of documented infection confirmed by culture, biopsy, genomic, or serologic findings post-randomization and requiring hospitalization or parenteral anti-infective treatment, or otherwise deemed significant by the investigator.|Baseline up to Month 12|FAS: all randomized participants who received at least 1 dose of study medication.||participants|||Number
742543|NCT00483756|Secondary|Glomerular Filtration Rate (GFR) by The Abbreviated Modification of Diet in Renal Disease (MDRD) Equation|GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR was calculated using abbreviated MDRD equation. GFR by abbreviated MDRD equation= 186 * (serum creatinine)^(-1.154) * (age in years)^(-0.203) * (0.742 if female) * (1.210 if black). A normal GFR is >90 mL/min/1.73 m^2, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR <15 mL/min/1.73 m^2 indicated kidney failure.|Month 1, 3, 6, 9, 12|FAS: all randomized participants who received at least 1 dose of study medication. Here, N (Number of Participants Analyzed) signifies participants evaluable for this measure. Missing data were imputed using LOCF.||mL/min per 1.73 m^2||Standard Deviation|Mean
742544|NCT00483756|Secondary|Glomerular Filtration Rate (GFR) by The Modification of Diet in Renal Disease (MDRD) Equation|GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was calculated using MDRD equation. GFR by MDRD equation = 170 * (serum creatinine)^(-0.999) * (age in years)^(-0.176) * (0.762 if female) * (1.18 if black) * (blood urea nitrogen concentration)^(-0.170) * (serum albumin concentration)^(0.318).A normal GFR is >90 mL/min/1.73 square meter (m^2), although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR <15 mL/min/1.73 m^2 indicated kidney failure.|Month 1, 3, 6, 9, 12|FAS: all randomized participants who received at least 1 dose of study medication. Here, N (Number of Participants Analyzed) signifies participants evaluable for this measure. Missing data were imputed using LOCF.||mL/min/1.73 m^2||Standard Deviation|Mean
742545|NCT00483756|Secondary|Glomerular Filtration Rate (GFR) by The Cockcroft-Gault Equation|GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR was calculated using Cockcroft-Gault equation. GFR by Cockcroft-Gault equation= body weight*(140 minus age in years) divided by (72*serum creatinine). For females value obtained was multiplied by 0.85. A normal GFR is >90 mL/min, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR <15 mL/min indicated kidney failure.|Month 1, 3, 6, 9, 12|FAS: all randomized participants who received at least 1 dose of study medication. Here, N (Number of Participants Analyzed) signifies participants evaluable for this measure. Missing data were imputed using LOCF.||mL/min||Standard Deviation|Mean
742546|NCT00483756|Secondary|Glomerular Filtration Rate (GFR) by The Nankivell Equation|GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR was calculated was estimated by creatinine clearance (CLcr) using Nankivell equation. CLcr by Nankivell equation= (6.7 per serum creatinine) plus (0.25*body weight) minus (0.5*serum urea) minus (100 per height square) plus (35 for male/25 for female). A normal GFR is >90 mL/min, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR <15 mL/min indicated kidney failure.|Month 1, 3, 6, 9, 12|FAS: all randomized participants who received at least 1 dose of study medication. Here, N (Number of Participants Analyzed) signifies participants evaluable for this measure. Missing data were imputed using Last Observation Carried Forward (LOCF).||mL/min||Standard Deviation|Mean
742547|NCT00483756|Secondary|Population Pharmacokinetics (PK)|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Pre-dose-2(P-2), Pre-dose(P), 0.5,1,2 hr post-dose(PD) on Day14, Month(M) 3; P,1,2 hr PD on M1; P, 0.5, 2, 4 hr PD on M6; P-2, P, 0.5 hr PD on M9, M12 as per randomization in CP-690,550 treated; P on M3 and P, 2, 4 hr PD on M6 in CsA treated participants||||||
742548|NCT00483756|Secondary|Lymphocyte Subset|The absolute cell counts of cluster of differentiation 3 (CD3): T-lymphocytes, cluster of differentiation 19 (CD19): B-lymphocytes, and cluster of differentiation 56 (CD56): assumed natural killer cells, were determined using flow cytometry.|Month 1, 3, 6, 12|FAS: all randomized participants who received at least 1 dose of study medication. Here, N (Number of Participants Analyzed) signifies participants evaluable for this measure; and 'n' signifies those participants who were evaluable at given time point for each group, respectively.||cells per microliter||Standard Deviation|Mean
742549|NCT00483756|Secondary|Number of Participants Who Died||Month 6, 12|FAS with last dosing risk set: all randomized participants who received at least 1 dose of study medication, including events occurring up to 7 days after last dose. Here, N (Number of Participants Analyzed): participants evaluable for this measure; and n: participants who remained at risk at given time point for each group, respectively.||participants|||Number
742550|NCT00483756|Secondary|Number of Participants With Efficacy Failure|Efficacy failure was the first occurrence of clinical BPAR diagnosed by the central pathologist or graft loss including participant death.|Month 6, 12|FAS with last dosing risk set: all randomized participants who received at least 1 dose of study medication, including events occurring up to 7 days after last dose. Here, N (Number of Participants Analyzed): participants evaluable for this measure; and n: participants who remained at risk at given time point for each group, respectively.||participants|||Number
748847|NCT00538642|Secondary|Abdominal Circumference||Baseline|||cm||Standard Deviation|Mean
742552|NCT00483756|Secondary|Number of Participants With Combined Banff Rejection Categories (Categories 2, 3, and 4)|Banff 97: standard classification for scoring and classifying rejection of kidney transplant biopsies in 6 diagnostic categories: normal, antibody-mediated rejection, borderline changes: ‘suspicious’ for acute cellular rejection, acute/active cellular rejection, chronic/sclerosing allograft nephropathy, and other. Combined Banff rejection calculated from categories of antibody-mediated rejection (Category 2) plus borderline changes (Category 3) plus acute rejection (Category 4), as interpreted by the central pathologist.|Month 6, 12|FAS with last dosing risk set: all randomized participants who received at least 1 dose of study medication, including events occurring up to 7 days after last dose. Here, N (Number of Participants Analyzed): participants evaluable for this measure; and n: participants who were evaluable at given time point for each group, respectively.||participants|||Number
742553|NCT00483756|Secondary|Number of Participants With Treated Clinical Acute Rejection|Treated clinical acute rejection was defined as an acute rejection episode that was diagnosed based on local biopsy readout and received anti-rejection treatment.|Month 6, 12|FAS with last dosing risk set: all randomized participants who received at least 1 dose of study medication, including events occurring up to 7 days after last dose. Here, N (Number of Participants Analyzed): participants evaluable for this measure; and n: participants who remained at risk at given time point for each group, respectively.||participants|||Number
742554|NCT00483756|Secondary|Number of Participants With First Clinical Biopsy Proven Acute Rejection (BPAR) 12 Months Post Transplant|Clinical BPAR was a BPAR (category acute rejection as interpreted by the central blinded pathologist according to the Banff 97 working classification) associated with an increase in serum creatinine of >= 0.3 mg/dL and >=20% from pre-rejection baseline. The increase in serum creatinine was assessed based on the comparison of baseline and the highest serum creatinine recorded within 24 hrs of the time of biopsy.|Baseline up to Month 12|FAS with last dosing risk set: all randomized participants who received at least 1 dose of study medication, including events occurring up to 7 days after last dose. Here, N (Number of Participants Analyzed) signifies participants evaluable for this measure.||participants|||Number
742555|NCT00483756|Secondary|Number of Participants With Progression of Chronic Allograft Lesions at Month 12|Progression of chronic allograft lesions was defined as an increase in the Banff chronicity score (Banff-CS) in biopsy from the implantation (baseline) biopsy in a given participant. Banff-CS was the sum of the Banff scores for the 4 chronic basic lesions (allograft glomerulopathy [cg] + interstitial fibrosis [ci] + tubular atrophy [ct] + vascular intimal thickening [cv]).The Banff-CS ranged from 0-12, higher score indicated greater lesions and Month 12 Banff-CS greater than the implantation biopsy score indicated progression of lesions.|Month 12|Per protocol (PP) population: all randomized participants who received at least 1 dose of study treatment; excluding participants who had a protocol deviation thought to affect the analyses. Here, N (Number of Participants Analyzed) includes only participants with evaluable data for this measure at both baseline and Month 12.||participants|||Number
742556|NCT00483756|Secondary|Glomerular Filtration Rate (GFR) at Month 6|GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was calculated using iohexol serum clearance. For determination of iohexol serum clearance, iohexol was administered as an intravenous bolus over 5 minutes immediately after morning dosing of CP-690,550 or CsA on day of GFR evaluation. A normal GFR is >90 mL/min, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR <15 mL/min indicated kidney failure.|2, 3, 4, and 5 hrs post iohexol intravenous bolus at Month 6|FAS: all randomized participants who received at least 1 dose of study medication. Here, N (Number of Participants Analyzed) includes only participants with evaluable data for this measure at Month 6.||mL/min||Standard Deviation|Mean
742557|NCT00483756|Primary|Glomerular Filtration Rate (GFR) at Month 12|GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was calculated using iohexol serum clearance. For determination of iohexol serum clearance, iohexol was administered as an intravenous bolus over 5 minutes immediately after morning dosing of CP-690,550 or CsA on day of GFR evaluation. A normal GFR is greater than (>) 90 milliliter per minute (mL/min), although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR less than (<) 15 mL/min indicated kidney failure.|2, 3, 4, and 5 hrs post iohexol intravenous bolus at Month 12|FAS: all randomized participants who received at least 1 dose of study medication. Here, N (Number of Participants Analyzed) includes only participants with evaluable data for this measure at Month 12.||mL/min||Standard Deviation|Mean
742558|NCT00483756|Primary|Number of Participants With First Clinical Biopsy Proven Acute Rejection (BPAR) Episode 6 Months Post-Transplant|Clinical BPAR was a BPAR (category acute rejection as interpreted by the central blinded pathologist according to the Banff 97 working classification) associated with an increase in serum creatinine of >= 0.3 milligram per deciliter (mg/dL) and >=20 percent (%) from pre-rejection baseline. The increase in serum creatinine was assessed based on the comparison of baseline and the highest serum creatinine recorded within 24 hours (hrs) of the time of biopsy.|Baseline up to Month 6|Full analysis set (FAS) with last dosing risk set: all randomized participants who received at least 1 dose of study medication, including events occurring up to 7 days after last dose. Here, N (Number of Participants Analyzed) signifies participants evaluable for this measure.||participants|||Number
742559|NCT00483938|Secondary|Percentage of Participants With Virological Responses (Groups A, B, C, D, E, and F)|End of treatment response (ETR) was defined as “Success” if the HCV-RNA levels were <15 IU/mL at the end of treatment. Early virological response (EVR) was defined as >=2 log10 decrease in serum HCV RNA or undetectable serum HCV RNA (<15 IU/mL) at Week 12. Complete EVR was defined as “Success”, if the HCV-RNA levels were <15 IU/mL at Week 12. Partial EVR was defined as “Success”, if there was a >=2 log10 drop in HCV-RNA at Week 12 compared to baseline but with a level that was still >=15 IU/mL at that time point.|Week 12 (Groups C, D, E, and F), and end of treatment (Weeks 48, 72, 36, 48, 24, and 48 for Groups A, B, C, D, E, and F, respectively)|ITT population||percentage of participants|||Number
742617|NCT00484419|Secondary|Change in Low-Density Lipoprotein-C(LDL-C) From Week 0(Baseline) to Week 16 Least Squares Mean|change in LDL-C from Week 0(baseline) to week 16 least squares mean with 95% confidence intervals change = week 16 - week 0.|16 weeks change = week 16 - week 0.|The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.||mg/dL||95% Confidence Interval|Least Squares Mean
746154|NCT00520767|Primary|Complete Hematologic Response||Up to 12 months|Individuals evaluable for response||participants|individuals||Number
742560|NCT00483938|Secondary|Percentage of Participants With SVR (Groups C, D, E, and F)|SVR was defined as success if the participant had HCV RNA levels <15 IU/mL as measured by COBAS AmpliPrep/COBAS TaqMan® HCV test at the 24-week untreated follow-up visit (HCV-RNA levels obtained at least 18 weeks after last dose of either pegylated-Interferon alfa-2a or ribavirin were considered if the 24-week untreated follow-up visit data were missing). Percentage of participants with SVR for Groups C, D, E, and F was reported in this analysis.|At 24-week untreated follow-up visit (up to 60, 72, 48, and 72 weeks for Groups C, D, E, and F, respectively)|ITT. Here, “Number of Participants Analyzed” = the participants who were evaluable for this outcome measure.||percentage of participants|||Number
742561|NCT00483938|Primary|Percentage of Participants With Sustained Virological Response (SVR) (Groups A and B)|SVR was defined as success if the participant had HCV RNA levels <15 IU/mL as measured by COBAS AmpliPrep/COBAS TaqMan® HCV test at the 24-week untreated follow-up visit (HCV-RNA levels obtained at least 18 weeks after last dose of either pegylated-Interferon alfa-2a or ribavirin were considered if the 24-week untreated follow-up visit data were missing). Percentage of participants with SVR for Groups A and B was reported in this analysis.|At 24-week untreated follow-up visit (up to 72 weeks for Group A, up to 96 weeks for Group B)|Intent-to-treat (ITT) population included randomized participants who received at least one dose of study medication and who had a baseline HCV-RNA which was at least 15 IU/mL. Here, “Number of Participants Analyzed” = the participants who were evaluable for this outcome measure.||percentage of participants|||Number
742562|NCT00484094|Secondary|Estimated Glomerular Filtration Rate (eGFR) Calculated by Nankivell Formula|Graft function was evaluated by eGFR using Nankivell formula. The investigator recorded the date of evaluation and the calculated value on the CRF.|At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier.|Efficacy Analysis Set.||mL/min||Full Range|Median
742563|NCT00484094|Secondary|Percentage of Participants With Survived Graft|Graft survival was defined as not showing graft loss at the time of evaluation.|At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier.|Efficacy Analysis Set; Participants who had available data.||Percentage of participants||95% Confidence Interval|Number
742564|NCT00484094|Secondary|Percentage of Participants Alive|The investigator recorded the participant’s survival status and evaluation date on the CRF.|At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier.|Efficacy Analysis Set; Participants who had available data.||Percentage of participants||95% Confidence Interval|Number
742565|NCT00484094|Secondary|Percentage of Participants With Biopsy-Confirmed Acute Rejection Using Banff 09 Diagnostic Categories for Renal Allograft Biopsies|Renal biopsy was required to confirm the diagnosis of acute rejection. However, due to the non-interventional nature of this study, biopsy could not be mandatory. The decision of whether to perform a biopsy was made at the discretion of the investigator and the result was collected if performed.|At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier.|Efficacy Analysis Set: Participants with efficacy data recorded on the case report form (CRF) at 6 months (±1 month) after initiating Rapamune administration or at the time of completing Rapamune administration (whichever was earlier) were included in the Efficacy Analysis Set.||Percentage of participants||95% Confidence Interval|Number
742566|NCT00484094|Primary|Percentage of Participants With Clinically Significent Abnormal Laboratory Test|Laboratory test was not mandatory because this study was a non-interventional study.|Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.|This analysis was not performed because laboratory data were not collected during the study.|||||
742567|NCT00484094|Primary|Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), Unexpected AEs/ADRs, and Unexpected SAEs/SADRs|All AEs reported after the start of administration of Rapamune were considered as treatment-emergent AEs and summarized. All AEs, except for those with causal relationship to the study drug assessed as “unlikely”, were considered as AEs whose causal relationship to the study drug could not be excluded and classified as ADRs. Unexpected AEs/ADRs were classified by medical review with reference to the local product document and confirmed by Pfizer.|Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.|Safety Analysis Set||Percentage of participants|||Number
742568|NCT00484159|Secondary|Successful Treatment|Greater or equal to 50% pain relief plus procedural satisfaction lasting at least 3 months. What is being measured is the number of participants with a positive outcome.|3-months postprocedure|||participants|||Number
742569|NCT00484159|Primary|Cost Per Successful Procedure|Total cost per effective treatment at 3-months. Successful procedure defined as greater or equal to 50% pain relief and satisfaction lasting at least 3 months.|3-months|||U.S. dollars|||Number
742570|NCT00484185|Other Pre-specified|Number of Participants Who Discontinued the Study Due to Adverse Events (AEs)|AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Number of participants who discontinued the study due to AEs was reported.|Baseline up to 6 months|Safety analysis set included all participants who received at least 1 dose of study medication including dropouts due to AEs.||participants|||Number
742571|NCT00484185|Other Pre-specified|Duration of Adverse Events (AEs)|Total time from onset of adverse event till the event is resolved. Duration of AE per event = AE stop date minus AE start date plus 1.|Baseline up to 6 months|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis.|||||
742572|NCT00484185|Secondary|Percentage of Participants With Efficacy Evaluation|The efficacy of study drug was rated as ‘very effective’, ‘effective’, ‘slightly ineffective’ and ‘ineffective’.|Baseline up to 6 months|Efficacy analysis set included all participants who received at least 1 dose of study medication for the approved indications and were evaluated upon its related parameters at least once. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.||percentage of participants|||Number
742573|NCT00484185|Secondary|Total Infusion of Study Medication|Total dose of study drug infused was calculated over the study duration.|Baseline up to 6 months|Efficacy analysis set included all participants who received at least 1 dose of study medication for the approved indications and were evaluated upon its related parameters at least once.||IU||Standard Deviation|Mean
742575|NCT00484185|Secondary|Mean Number of Breakthrough Bleeds Within 48 Hours of Study Medication|Mean frequency of breakthrough (spontaneous/non-traumatic) bleeds of each participant within 48 hours of a preventive/prophylaxis dose of BeneFIX was calculated from number of irregular bleeding which occurred in each participant. Mean frequency breakthrough bleeds for total participants within 48 hours of a preventive/prophylaxis dose of BeneFIX was summarized.|Baseline up to 6 months|Efficacy analysis set included all participants who received at least 1 dose of study medication for the approved indications and were evaluated upon its related parameters at least once. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.||breakthrough bleeds||Standard Deviation|Mean
742576|NCT00484185|Secondary|Mean Number of Infusion of Study Medication|Mean frequency of BeneFIX administration of each participant was calculated from number of BeneFIX infusions which each participant received for treatment of each new bleed. Mean frequency of BeneFIX administration for total participants was summarized.|Baseline up to 6 months|Efficacy analysis set included all participants who received at least 1 dose of study medication for the approved indications and were evaluated upon its related parameters at least once. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.||infusions||Standard Deviation|Mean
742577|NCT00484185|Secondary|Number of Responses to On-demand Treatment With Study Medication|Responses to on-demand treatment were rated by participant/caregiver or physician each time the drug was administered, on 4-point scale. Score 1=excellent (definite pain relief [PR] and improvement [imp] within 8 hours [h] of infusion [inf], no additional inf); score 2=good (definite PR and imp within 8h of inf, at least 1 additional inf for complete resolution [CR] of bleeding or starting after 8h of inf, no additional inf); score 3=moderate (probable or slight imp starting after 8h of inf, at least 1 additional inf for CR of bleeding); score 4=no imp at all, or condition worsens).|Baseline up to 6 months|Efficacy analysis set included all participants who received at least 1 dose of study medication for the approved indications and were evaluated upon its related parameters at least once. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.||responses|||Number
742578|NCT00484185|Secondary|Mean Annualized Bleeding Rate (ABR)|An annualized bleeding rate (ABR) was calculated as the number of bleeds requiring administration of BeneFIX (for on-demand therapy and surgery), divided by total period of bleeding multiplied by 365.25. Total period of bleeding is the number of days on treatment for prophylaxis purpose and on-demand therapy and surgery.|Baseline up to 6 months|Efficacy analysis set included all participants who received at least 1 dose of study medication for the approved indications and were evaluated upon its related parameters at least once. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.||bleeds per year||Standard Deviation|Mean
742579|NCT00484185|Primary|Number of Participants With Unexpected Adverse Events (AEs)|AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Unexpected AEs were those that were not included in precaution of local product document.|Baseline up to 6 months|Safety analysis set included all participants who received at least 1 dose of study medication including dropouts due to AEs.||participants|||Number
742580|NCT00484185|Primary|Number of Participants With Adverse Events (AEs) by Relationship|AE: untoward medical occurrence in participant who received study drug without regard to causal relationship. All causalities and drug-related AEs reported. Drug-related AEs based on physician’s discretion: certain (AE after drug intake, not explained by other drugs, reaction on drug cessation [DC], relapse on re-intake of drug), probable/likely (AE after drug intake, not explained by other drugs, reaction on DC, no information on re-intake), possible (AE after drug intake, explained by other drugs, no information on DC), unlikely (not related to drug intake time, explained by other drugs).|Baseline up to 6 months|Safety analysis set included all participants who received at least 1 dose of study medication including dropouts due to AEs.||participants|||Number
742581|NCT00484185|Primary|Number of Participants With Outcome in Response to Adverse Events (AEs)|AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Outcome of an AE was assessed based on response to a question ‘Is the adverse event still present?’ as ‘yes’, ‘unknown’ or ‘no-resolved'.|Baseline up to 6 months|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis.|||||
742582|NCT00484185|Primary|Number of Participants With Adverse Events (AEs) According to Seriousness|AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Seriousness of an AE was assessed under the criteria of serious adverse event (SAE). An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to 6 months|Safety analysis set included all participants who received at least 1 dose of study medication including dropouts due to AEs.||participants|||Number
742583|NCT00484185|Primary|Number of Participants With Action Taken in Response to Adverse Events (AEs)|AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. After an onset of an AE, relevant actions were undertaken on the study drug or the participant. Actions related to study drug included: dosage reduced, dosage increased, stopped temporarily or permanently, no action taken; actions related to participants included: withdrawal from the study, concomitant medication, no action taken or any other as per physician’s discretion.|Baseline up to 6 months|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis.|||||
742584|NCT00484185|Primary|Number of Participants With Adverse Events (AEs) According to Severity|AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed according to severity; mild (not causing any significant problem, dose adjustment not required), moderate (caused problem that does not interfere significantly with usual activities or the clinical status, dose adjustment needed due to adverse event) and severe (caused problem that interferes significantly with usual activities or the clinical status, study drug stopped due to adverse event).|Baseline up to 6 months|Safety analysis set included all participants who received at least 1 dose of study medication including dropouts due to AEs. Same participant may be represented in more than 1 category.||participants|||Number
748848|NCT00538642|Secondary|Body Mass Index||4-5 months|||Kg/m2||Standard Deviation|Mean
742585|NCT00484185|Primary|Number of Participants With Adverse Events (AEs) According to Baseline Characteristics|AE: any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. AE assessed by baseline characteristics (chr) included age, gender, pediatric/geriatric status, liver disorder, BeneFIX treatment (previously/newly), factor nine (FIX) gene mutation, prior exposure to plasma-derived FIX products, prior FIX regimen(s) utilized, personal history of FIX inhibitor, family history of hemophilia B, severity of bleeding, medical history, concomitant medication and therapy.|Baseline up to 6 months|Safety analysis set included all participants who received at least 1 dose of study medication including dropouts due to AEs.||participants|||Number
742586|NCT00484289|Primary|Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator||At week 0, 2, 4; then once every 4 weeks up to 48 months; then once in every 3 months or 12 weeks to end of study (27 Dec 2010). The overall mean duration of exposure to the study drug was approximately 3 years (34.3 ± 10.7 months).|All treated participants who received at least 1 dose of the study drug.||participants|||Number
742587|NCT00484289|Secondary|Abatacept PK Parameter: Minimum Plasma Concentration at Steady State|Minimum Plasma Concentration (Cmin) is the minimum observed serum drug concentration at steady state.|Samples were collected predose at week 8, 12, 16, 24; end of infusion at week 12; and at week 13-15 visits.|All participants who received abatacept and had blood samples for assay.||µg/mL||Full Range|Median
742588|NCT00484289|Secondary|Abatacept PK Parameter: Maximum Serum Concentration at Steady State|Maximum plasma concentration is the maximum observed serum drug concentration at steady state (Css max).|Samples were collected predose at week 8, 12, 16, 24; end of infusion at week 12; and at week 13-15 visits.|All participants who received abatacept and had blood samples for assay.||µg/mL||Full Range|Median
742589|NCT00484289|Secondary|Abatacept PK Parameter: Area Under the Serum Concentration-time Curve at Steady State|Area under the plasma concentration-time curve (AUCss) at steady state for each dosing interval was determined using the linear trapezoidal rule.|Samples were collected predose at week 8, 12, 16, 24; end of infusion at week 12; and at week 13-15 visits.|All participants who received abatacept and had blood samples for assay.||µg*h/mL||Full Range|Median
742590|NCT00484289|Secondary|Abatacept PK Parameter: Total Body Clearance|Total body clearance is the rate and extent at which the drug is eliminated from the body. The clearance of a drug is used to understand the processes involved in drug elimination, distribution and metabolism.|Samples were collected predose at week 8, 12, 16, 24; end of infusion at week 12; and at week 13-15 visits.|All participants who received abatacept and had blood samples for assay.||L/day||Full Range|Median
742591|NCT00484289|Secondary|Number of Participants Who Were Positive for Anti-abatacept and Anti-CTLA4-T Antibodies|Validated enzyme-linked immunoassay (ELISA) method was used to measure anti-abatacept and anti-CTLA4-T antibody levels. For anti-abatacept antibody ELISA, a sample was considered seropositive if it had a titer of 400 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of < 400. A sample was considered positive in CTLA4-T antibody ELISA if it had a titer of 25 or greater and if immunodepletion was observed.|At BL (week 0), weeks 24, 48, 72, 96, 120, 144, 168, and 192.|All participants who received study treatment, and had BL and at least one PBL measurement for immunogenicity.||participants|||Number
742592|NCT00484289|Secondary|Change From Baseline in Rheumatoid Factor Levels at Weeks 24, 48, 96, 144, and 192|RF is an autoantibody (antibody directed against an organism's own tissues) most relevant in rheumatoid arthritis. It is an antibody against the Fc portion of Immunoglobulin (Ig)G, which is itself an antibody. RF and IgG join to form immune complexes which contribute to the disease process. RF levels are considered positive if value is >20 and considered negative if value is <20. Please refer to outcome 19 for BL and PBL values.|At BL (week 0), weeks 24, 48, 96, 144, and 192.|All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given point time point.||IU/mL||95% Confidence Interval|Mean
742593|NCT00484289|Secondary|Baseline and Postbaseline Rheumatoid Factor Levels|Rheumatoid factor (RF or RhF) is an autoantibody (antibody directed against an organism's own tissues) most relevant in rheumatoid arthritis. It is an antibody against the Fc portion of Immunoglobulin (Ig)G, which is itself an antibody. RF and IgG join to form immune complexes which contribute to the disease process. RF levels are considered positive if value is >20 and considered negative if value is <20. Please see outcome 20 for change from BL data.|At BL (week 0), weeks 24, 48, 96, 144, and 192.|All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given point time point.||IU/mL||Standard Deviation|Mean
742594|NCT00484289|Secondary|Percentage Decrease in C-reactive Protein Levels From Baseline at Weeks 24, 48, 96, 144, and 192|CRP is an acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA) and is a core component of the ACR scoring system. CRP was evaluated from serum samples. Increasing levels indicate increasing level of disease, negative values indicate improvement. Percentage improvement from BL = (BL - PBL value) / BL value * 100. Please refer to outcome 17 for BL and PBL values.|At BL (week 0), weeks 24, 48, 96, 144, and 192.|All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given point time point.||percentage improvement||95% Confidence Interval|Mean
742595|NCT00484289|Secondary|Baseline and Postbaseline C-reactive Protein (CRP) Levels|CRP is an acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA) and is a core component of the ACR scoring system. CRP was evaluated from serum samples. Increasing levels indicate increasing level of disease. Please see outcome 18 for change from BL data.|At BL (week 0), weeks 24, 48, 96, 144, and 192.|All treated participants who received at least 1 dose of the study drug. n = number of participants with both BL and PBL measurement at a given point time point.||mg/dL||Standard Deviation|Mean
742605|NCT00484289|Secondary|Change From Baseline in DAS 28 Scores at Week 24, 48, 96, 144, and 192|The DAS 28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, CRP levels, and participant assessment of disease activity measure on a visual analogue scale of 100 mm. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (≤ 3.2) and remission (< 2.6). Please refer to outcome 7 for BL and PBL values.|At BL (week 0), weeks 24, 48, 96, 144, and 192.|All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given time point.||Units on a Scale||95% Confidence Interval|Mean
748849|NCT00538642|Secondary|Body Mass Index||Baseline|||Kg/m2||Standard Deviation|Mean
742596|NCT00484289|Secondary|Change From Baseline in Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Score at Weeks 24, 48, 96, 144, and 192|The SF-36 covers 8 health dimensions including 4 physical (physical function, role functioning [physical], bodily pain, and general health) and 4 mental subscales (vitality, social function, role emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.Please see outcome 15 for BL and PBL values.|At BL (Week 0), weeks 24, 48, 96, 144, and 192.|All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given point time point.||Units on a Scale||95% Confidence Interval|Mean
742597|NCT00484289|Secondary|Baseline and Postbaseline Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Scores|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role functioning [physical], bodily pain, and general health) and 4 mental subscales (vitality, social function, role emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful. Please see outcome 14 for change from BL data.|At BL (week 0), weeks 24, 48, 96, 144, and 192.|All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given point time point.||Units on a Scale||Standard Deviation|Mean
742598|NCT00484289|Secondary|Change From Baseline in Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Score at Weeks 24, 48, 96, 144, and 192|The SF-36 covers 8 health dimensions including 4 physical (physical function, role functioning [physical], bodily pain, and general health) and 4 mental subscales (vitality, social function, role emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, higher score indicating better quality of life. Improvements of >3 points were considered clinically meaningful. Please see outcome 13 for BL and PBL values.|At baseline (week 0), weeks 24, 48, 96, 144, and 192.|All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given point time point.||Units on a Scale||95% Confidence Interval|Mean
742599|NCT00484289|Secondary|Baseline and Postbaseline Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Scores|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role functioning [physical], bodily pain, and general health) and 4 mental subscales (vitality, social function, role emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.Please see outcome 14 for change from BL data.|At BL (week 0), weeks 24, 48, 96, 144, and 192.|All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given point time point.||Units on a Scale||Standard Deviation|Mean
742600|NCT00484289|Secondary|Percentage of Participants Who Achieved a Reduction of At Least 0.3 Units From Baseline in Health Assessment Questionnaire (HAQ) at Weeks 24, 48, 96, 144, 192|The disability section of the full HAQ includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Higher scores= greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ response=an improvement of at least 0.3 units from BL in HAQ.|At BL (week 0), weeks 24, 48, 96, 144, and 192.|All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given time point.||percentage of participants||95% Confidence Interval|Number
742601|NCT00484289|Secondary|Number of Participants in Remission (DAS 28 Score < 2.6) at Weeks 24, 48, 96, 144, 192|"The DAS 28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, CRP levels, and participant assessment of disease activity measure on a visual analogue scale.
Participants with DAS 28 score < 2.6 were considered to be in remission."|At weeks 24, 48, 96, 144, and 192.|All treated participants who received at least 1 dose of the study drug. n = participants with available scores at the given time point.||participants|||Number
742602|NCT00484289|Secondary|Number of Participants With Low Disease Activity Score (DAS 28 Score ≤ 3.2) at Weeks 24, 48, 96, 144, 192|The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, CRP levels, and participant assessment of disease activity measure on a visual analogue scale. Participants with DAS 28 score ≤ 3.2 were considered to have low disease activity.|At weeks 24, 48, 96, 144, and 192.|All treated participants who received at least 1 dose of the study drug. n = participants with available scores at the given time point.||participants|||Number
742603|NCT00484289|Primary|Number of Participants With Abnormal Laboratory Changes (ALC)|The laboratory tests were analyses included enzyme, gastrointestinal, hematology, hepatobiliary, lipid, metabolic, nutritional, blood gas, microbiology, serology, protein, chemistry, renal, urinary tract, urinalyses, water, electrolyte and mineral investigations.|From initiation of the study drug (31 Mar 2008) to data cutoff (27 Dec 2010). The overall mean duration of exposure to the study drug was approximately 3 years (34.3 ± 10.7 months).|All treated participants who received at least 1 dose of the study drug.||participants|||Number
742604|NCT00484289|Secondary|Number of Participants With DAS 28 Score Change ≥ 1.2 From Baseline at Weeks 24, 48, 96, 144, and 192|"The DAS 28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, CRP levels, and participant assessment of disease activity measure on a visual analogue scale.
Participants with DAS 28 score change ≥ 1.2 from BL were considered to have improvement."|At BL (week 0), weeks 24, 48, 96, 144, and 192.|All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given time point.||participants|||Number
746155|NCT00520845|Other Pre-specified|Changes in Urinary PGE-M and Survival as Assessed by Immunohistochemistry||At 1 year|data is not available. no analysis done|||||
742606|NCT00484289|Secondary|Baseline (BL) and Postbaseline (PBL) Disease Activity Scores (DAS 28)|The DAS 28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, CRP levels, and participant assessment of disease activity measure on a visual analogue scale of 100 mm. The DAS28 has numeric thresholds that define high disease activity (change of > 5.1), low disease activity (change of ≤ 3.2) and remission (< 2.6). Please see outcome 8 for change from BL data.|At BL (week 0), week 24, 48, 96, 144, and 192.|All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given time point.||Units on a Scale||Standard Deviation|Mean
742607|NCT00484289|Secondary|Percentage of Participants With ACR 70 Response Over Time|ACR 70 response requires a participant to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease activity, participant global assessment of disease activity, participant global assessment of pain, C-reactive protein, and degree of disability in Health Assessment Questionnaire score.|At weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192.|All treated participants who received at least 1 dose of the study drug. n = Number of participants assessed at given time point.||percentage of participants||95% Confidence Interval|Number
742608|NCT00484289|Secondary|Percentage of Participants With ACR 50 Response Over Time|ACR 50 response requires a participant to have a 50% reduction in the number of swollen and tender joints, and a reduction of 50% in three of the following five parameters: physician global assessment of disease activity, participant global assessment of disease activity, participant global assessment of pain, C-reactive protein, and degree of disability in Health Assessment Questionnaire score.|At weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192.|All treated participants who received at least 1 dose of the study drug. n = Number of participants assessed at given time point.||percentage of participants||95% Confidence Interval|Number
742609|NCT00484289|Secondary|Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time|ACR 20 response requires a participant to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease activity, participant global assessment of disease activity, participant global assessment of pain, C-reactive protein, and degree of disability in Health Assessment Questionnaire score.|At weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192.|All treated participants who received at least 1 dose of the study drug. n = number of participants assessed at given time point.||percentage of participants||95% Confidence Interval|Number
742610|NCT00484289|Primary|Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations Due to AEs|AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event. Both subjective and objective AEs and SAEs are included.|From initiation of the study drug (31 Mar 2008) to data cutoff (27 Dec 2010). The overall mean duration of exposure to the study drug was approximately 3 years (34.3 ± 10.7 months).|All treated participants who received at least 1 dose of the study drug.||participants|||Number
742611|NCT00484315|Secondary|In-segment Percent Diameter Stenosis at 9 Months Post-index Procedure|The minimum lumen diameter in the analysis segment at 9-months post-index procedure, divided by the reference vessel diameter at baseline. The analysis segment (“in-segment”) is defined as the proximal edge, stented area, and the distal edge, where each edge segment contains up to 5mm immediately outside the stent.|9 months post-index procedure|All patients from the per protocol analysis set who were randomized to the angiographic subset and completed their angiographic follow-up were analyzed for the secondary endpoint.||percent diameter stenosis||Standard Deviation|Mean
742612|NCT00484315|Primary|Target Lesion Failure (TLF) at 12 Months Post-index Procedure. TLF is Defined as Any Ischemia-driven Revascularization of the Target Lesion, Myocardial Infarction (Q-wave and Non-Q-wave), or Death Related to the Target Vessel.|The number of participants who experience a TLF through 365 days post-procedure out of the participants who have either had a TLF within 365 days post-procedure or who were TLF-free with last follow-up at least 335 days post-procedure.|12 months post-index procedure|The primary analysis set for the non-inferiority testing of the primary endpoint, 12-month TLF, is the per protocol analysis set. All randomized participants who had the randomly assigned study stent implanted in the target coronary artery are included.||participants|||Number
742613|NCT00484393|Primary|To Determine if a Difference in Pain Scale Ratings is Detectable Following Intramuscular Palivizumab Injection That Was Pre-treated With Placebo or Tetracaine.|Parent score 1-10 (1 representing no pain and 10 representing extreme pain) FLACC (Face, Legs, Activity, Cry, Consolability) Score 0-10 (at baseline and post injection) (0 representing no pain and 10 representing extreme pain) Change in FLACC score|2 visits, 1 month apart|Each participant was evaluated for repsonse following tetracaine and following placebo||units on a scale||Full Range|Mean
742614|NCT00484419|Secondary|Mean Percentage of Change in LDL-C Levels From Week 0(Baseline) to Week 16 (Least Squares Mean)|percent change in LDL-C levels from Week 0(baseline) to Week 16 (least squares mean with 95% confidence interval)|16 weeks change = week 16 - week 0.|The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.||% change in LDL-C||95% Confidence Interval|Least Squares Mean
742615|NCT00484419|Secondary|Mean Percentage of Change in LDL-C Levels From Week 0(Baseline) to Week 16|mean percent change in LDL-C levels from Week 0(baseline) to Week 16 mean with standard deviation change = week 16 - week 0.|16 weeks change = week 16 - week 0.|The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.||% change in LDL-C||Standard Deviation|Mean
742616|NCT00484419|Secondary|Mean Change in LDL-C From Week 0(Baseline) to Week 16|mean change in LDL-C from Week 0(baseline) to week 16 with standard deviation change = week 16 - week 0.|16 weeks change = week 16 - week 0.|The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.||mg/dL||Standard Deviation|Mean
746156|NCT00520845|Other Pre-specified|Effect of Celecoxib on Urinary Metabolites of PGE2, PG12 and Thromboxane||At 1 year|data is not available. no analysis done|||||
742618|NCT00484419|Secondary|Mean Change in Post-prandial Insulin From Week 0(Baseline) to Week 16|mean change in post-prandial insulin from Week 0(baseline) to week 16 with standard deviation change = week 16 - week 0.|16 weeks change = week 16 - week 0.|The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.||mg/dL||Standard Deviation|Mean
742619|NCT00484419|Secondary|Mean Change in Post-prandial Glucose From Week 0(Baseline) to Week 16|mean change in post-prandial glucose from Week 0(baseline) to week 16 with standard deviation change = week 16 - week 0.|16 weeks change = week 16 - week 0.|The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.||mg/dL||Standard Deviation|Mean
742620|NCT00484419|Secondary|Change in Post-prandial Glucose From Week 0(Baseline) to Week 16 Least Squares Mean|change in post-prandial glucose from Week 0(baseline) to week 16 least squares mean with 95% confidence intervals change = week 16 - week 0.|16 weeks change = week 16 - week 0.|The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.||mg/dL||95% Confidence Interval|Least Squares Mean
742621|NCT00484419|Secondary|Mean Change in Fasting Insulin From Week 0(Baseline) to Week 16|mean change in fasting insulin from Week 0(baseline) to week 16 with standard deviation change = week 16 - week 0.|16 weeks change = week 16 - week 0.|The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.||uIU/mL||Standard Deviation|Mean
742622|NCT00484419|Secondary|Mean Change in Fasting Insulin From Week 0(Baseline) to Week 8|mean change in fasting insulin from Week 0(baseline) to week 8 with standard deviation change = week 8 - week 0.|8 weeks change = week 8- week 0.|The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.||uIU/mL||Standard Deviation|Mean
742623|NCT00484419|Secondary|Change in Fasting Insulin From Week 0(Baseline) to Week 16 Least Squares Mean|change in fasting insulin from Week 0(baseline) to week 16 least squares mean and 95% confidence interval change = week 16 - week 0.|16 weeks change = week 16 - week 0.|The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.||uIU/mL||95% Confidence Interval|Least Squares Mean
742624|NCT00484419|Secondary|Change in Fasting Insulin From Week 0(Baseline) to Week 8 Least Squares Mean|change in fasting insulin from Week 0(baseline) to week 8 least squares mean and 95% confidence interval change = week 8 - week 0.|8 weeks change = week 8- week 0.|The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.||uIU/mL||95% Confidence Interval|Least Squares Mean
742625|NCT00484419|Secondary|Mean Change in FPG From Week 0(Baseline) to Week 16|change in FPG from Week 0(baseline) to week 16 mean and standard deviation change = week 16 - week 0.|16 weeks change = week 16 - week 0.|The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.||mg/dL||Standard Deviation|Mean
742626|NCT00484419|Secondary|Mean Change in FPG From Week 0(Baseline) to Week 8|mean change in FPG from Week 0(baseline) to Week 8 with standard deviation change = week 8 - week 0.|8 weeks change = week 8- week 0.|||mg/dL||Standard Deviation|Mean
742627|NCT00484419|Secondary|Change in FPG From Week 0(Baseline) to Week 16 Least Squares Mean|change in FPG from Week 0(baseline) to week 16 least squares mean and 95% confidence interval change = week 16 - week 0.|16 weeks change = week 16 - week 0.|The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.||mg/dL||95% Confidence Interval|Least Squares Mean
742628|NCT00484419|Secondary|Change in Fasting Plasma Glucose (FPG) From Week 0(Baseline) to Week 8 Least Squares Mean|change in FPG from Week 0(baseline) to week 8 least squares mean and 95% confidence interval change = week 8 - week 0.|8 weeks change = week 8- week 0.|The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.||mg/dL||95% Confidence Interval|Least Squares Mean
742629|NCT00484419|Primary|Mean Percentage of Change in HbA1c From Week 0(Baseline) to Week 16 Endpoint|Change in HbA1c from Week 0(baseline) to Week 16 endpoint mean with standard deviation change = week 16 - week 0.|16 weeks change = week 16 - week 0.|The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.||% change HbA1c||Standard Deviation|Mean
742630|NCT00484419|Secondary|Mean Percentage of Change in HbA1c From Week 0(Baseline) to Week 8|change in HbA1c from Week 0(baseline) to week 8 mean and standard deviation change = week 8 - week 0.|8 weeks change = week 8- week 0.|||% change in HbA1c||Standard Deviation|Mean
742631|NCT00484419|Secondary|Mean Percentage of Change in Glycosylated Hemoglobin (HbA1c) From Week 0(Baseline) to Week 16 Endpoint Least Squares Mean|Change in HbA1c from Week 0(baseline)to Week 16 endpoint least squares mean with 95% confidence intervals, change = week 16 - week 0.|16 weeks change = week 16 - week 0.|The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.||% change in HbA1c||95% Confidence Interval|Least Squares Mean
742632|NCT00484679|Primary|Mean Change in Cortisol Levels From Baseline to Week 24|Mean change in cortisol levels from baseline to week 24 after four triamcinolone acetonide 10 ml injections 6 weeks apart.|baseline, week 24|Participants who completed all treatment and follow-up visits||mg/dL||Standard Deviation|Mean
742633|NCT00484939|Secondary|AEs, Laboratory Parameters, Vital Signs||Throughout study||||||
742634|NCT00484939|Secondary|Duration of Follow-up|Duration of follow-up is defined as the time in days from randomization until disease progression or death, or time to censoring for overall survival.|Baseline to the end of the study (up to 5 years 8 months)|Intent-to-treat population: All participants randomized into the study.||Days||Standard Deviation|Mean
742635|NCT00484939|Secondary|Percentage of Participants Requiring Additional Treatment for Malignancy|Reported is the percentage of participants requiring additional treatment for malignancy in the survival follow-up period.|Baseline to the end of the study (up to 5 years 8 months)|Intent-to-treat population: All participants randomized into the study.||Percentage of participants|||Number
742636|NCT00484939|Secondary|Eastern Cooperative Oncology Group (ECOG) Performance Status|The ECOG performance status is a scale used to quantify cancer patients' general well-being and activities of daily life. The scale ranges from 0 to 5, with 0 denoting perfect health and 5 indicating death. The 6 categories are 0=Asymptomatic (Fully active, able to carry on all predisease activities without restriction), 1=Symptomatic but completely ambulatory (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature), 2=Symptomatic, < 50% in bed during the day (Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours), 3=Symptomatic, > 50% in bed, but not bedbound (Capable of only limited self-care, confined to bed or chair 50% or more of waking hours), 4=Bedbound (Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair), 5=Death. Reported is the percentage of participants in each of the 6 ECOG performance status categories.|Baseline to the Safety Follow-up which occurred 28 days after the last dose of treatment (up to 5 years 8 months).|Intent-to-treat population: All participants randomized into the study.||Percentage of participants|||Number
742637|NCT00484939|Secondary|Overall Survival|Overall survival was defined as the time in months from randomization to death from any cause.|Baseline to the end of the study (up to 5 years 8 months)|Intent-to-treat population: All participants randomized into the study.||Months||95% Confidence Interval|Median
742638|NCT00484939|Secondary|Time to Response|Time to response was defined as the time in months from the date of first study treatment to the date of the first documentation of complete response (CR) or partial response (PR), whichever occurred first. CR was defined as the disappearance of all target (TL) and non-target lesions (non-TL). PR was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD, or the persistence of 1 or more non-TLs. Participants who did not have a confirmed response were censored at the date of the last evaluable tumor assessment, or if that was unavailable, at the date of the first dose of study medication.|Baseline to the end of the study (up to 5 years 8 months)|Intent-to-treat population: All participants randomized into the study.||Months||95% Confidence Interval|Median
742639|NCT00484939|Secondary|Duration of Response|Duration of response was defined as the time in months from the first confirmed complete response (CR) or partial response (PR) until disease progression or death from any cause, whichever occurred first. CR was defined as the disappearance of all target (TL) and non-target lesions (non-TL). PR was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD, or the persistence of 1 or more non-TLs.|Baseline to the end of the study (up to 5 years 8 months)|Intent-to-treat population: All participants randomized into the study. Only participants with a complete response or partial response were included in the analysis.||Months||95% Confidence Interval|Median
742640|NCT00484939|Secondary|Best Overall Response (BOR)|BOR was defined as the best response (complete response [CR], partial response [PR], stable disease [SD], progressive disease [PD], not evaluable [NE], or not assessed [NA]) recorded from the start of study treatment until disease progression (PD) or death. CR was defined as the disappearance of all target (TL) and non-target lesions (non-TL). PR was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD, or the persistence of 1 or more non-TLs. For TLs, SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since treatment started. For non-TLs, SD was defined as the persistence of 1 or more lesions. PD was defined as ≥ 20% increase in the sum of the longest diameter of TLs, taking as reference the smallest SLD recorded since treatment started, the unequivocal progression of existing non-TLs, or the appearance of 1 or more new lesions.|Baseline to the end of the study (up to 5 years 8 months)|Intent-to-treat population: All participants randomized into the study. Only participants with a response were included in the analysis.||Percentage of participants||95% Confidence Interval|Number
742641|NCT00484939|Primary|Progression-free Survival|Progression-free survival was defined as the time in months from the date of randomization to the date of disease progression or death from any cause, whichever occurred first. All measurable lesions (maximum of 5 per organ and 10 in total, those with the longest diameter and suitability for accurate repeated measurements) were identified as target lesions (TL). A sum of the longest diameter for all TLs was calculated and reported as the baseline sum longest diameter (SLD). All other lesions were identified as non-TLs and recorded at baseline. PD was defined as ≥ 20% increase in the sum of the longest diameter of TLs, taking as reference the smallest SLD recorded since treatment started, the unequivocal progression of existing non-TLs, or the appearance of 1 or more new lesions.|Baseline to the end of the study (up to 5 years 8 months)|Intent-to-treat population: All participants randomized into the study.||Months||95% Confidence Interval|Median
742642|NCT00485069|Secondary|"Mean Change From Baseline in Awake Time Off (Hours) and Awake Time On (Hours) at Week 52 and FAP in the ROP+L-Dopa Group Excluding Participants With 0 Off (Hour) at Baseline"|"Off state is where PD symptoms are not adequately controlled by the drug. On state is where PD symptoms are well controlled by the drug. The off’s duration (awake time spent off) and the on’s duration (awake time spent on) on each day were calculated."|Baseline, Week 52, and FAP (up to Week 52)|"FAS. LOCF was used for the FAP data to impute post-baseline missing values. Participants having off hour of zero at baseline were not included at FAP. These participants as well as those prematurely withdrawn from the study were not included at Week 52."||hours||Standard Deviation|Mean
742643|NCT00485069|Secondary|Number of Participants Scored as Responders on the Clinician's Global Impression (CGI) Scale at Week 52 and FAP|"CGI is measured on the following 7-point scale: 1, Very much improved; 2, Much Improved; 3, Minimally improved; 4, No change; 5, Minimally worse; 6, Much worse; and 7, Very much worse. Responders are defined as those participants scored as very much improved or much improved."|Week 52 and FAP (up to Week 52)|FAS. LOCF was used for the FAP data to impute post-baseline missing values. One participant was not included in the ROP+L-dopa group at FAP as having no post-baseline data. This participant as well as those prematurely withdrawn from the study in each group was not included at Week 52.||participants|||Number
742644|NCT00485069|Secondary|Percentage of Participants Remaining in the Study on the Indicated Days in the ROP Group|The percentage of participants remaining in the study was presented by Kaplan-Meier method, where premature discontinuation (i.e., withdrawal before Week 52) was the event, and participants who had completed the study were censored.|Days 0-419|FAS||percentage of participants|||Number
746797|NCT00524121|Secondary|Correlation of Smoking Status With Overall Survival||5 years|Patients Treated with Study Therapy||months||95% Confidence Interval|Median
742646|NCT00485069|Secondary|Mean Change From Baseline in the Schwab and England Activities of Daily Living Scale Score by Clinician at Week 52 and FAP in ROP Group|The Schwab and England Activities of Daily Living Scale Score is measured as percentage, from 100% (Completely independent. Able to do all chores without slowness, difficulty or impairment. Essentially normal. Unaware of any difficulty) to 0% (Vegetative functions such as swallowing, bladder and bowel functions are not functioning. Bedridden).|Baseline, Week 52, and FAP (up to Week 52)|FAS. LOCF was used for the FAP data to impute post-baseline missing values. Participants prematurely withdrawn from the study were not included at Week 52.||percent change||Standard Deviation|Mean
742647|NCT00485069|Secondary|"Mean Change From Baseline in the Schwab and England Activities of Daily Living Scale Score by Clinician at Week 52 and FAP by On/Off State in the ROP+L-Dopa Group"|The Schwab and England Activities of Daily Living Scale Score is measured as percentage, from 100% (Completely independent. Able to do all chores without slowness, difficulty or impairment. Essentially normal. Unaware of any difficulty) to 0% (Vegetative functions such as swallowing, bladder and bowel functions are not functioning. Bedridden).|Baseline, Week 52, and FAP (up to Week 52)|"FAS. LOCF was used for the FAP data. Some participants were not included at FAP as having no post-baseline data in on state, not having off state at baseline in off state, or having no data in the corresponding state at Week 52/withdrawal. These participants as well as those prematurely withdrawn were not included at Week 52."||percent change||Standard Deviation|Mean
742648|NCT00485069|Secondary|Number of Participants at Each Stage of the Modified Hoehn & Yahr Scale at Baseline, Week 52, and FAP in the ROP Group|The Modified Hoehn & Yahr criteria are measured on the following 8-point scale for staging: 0, No signs of disease; 1, Unilateral disease; 1.5, Unilateral plus axial involvement; 2, Bilateral disease; 2.5, Mild bilateral disease; 3, Mild to moderate bilateral disease; 4, Severe disability; and 5, Wheelchair bound or bedridden unless aided.|Number of Participants at Each Stage of the Modified Hoehn & Yahr Scale at Baseline, Week 52, and FAP in the ROP Group|FAS. LOCF was used for the FAP data to impute post-baseline missing values. Participants prematurely withdrawn from the study were not included at Week 52.||participants|||Number
742649|NCT00485069|Secondary|"Number of Participants at Each Stage of the Modified Hoehn & Yahr Scale at Baseline, Week 52, and FAP by On/Off State in the ROP+L-Dopa Group"|The Modified Hoehn & Yahr criteria are measured on the following 8-point scale for staging: 0, No signs of disease; 1, Unilateral disease; 1.5, Unilateral plus axial involvement; 2, Bilateral disease; 2.5, Mild bilateral disease; 3, Mild to moderate bilateral disease; 4, Severe disability; and 5, Wheelchair bound or bedridden unless aided. LOCF was used for the FAP data to impute post-baseline missing values. Some participants in each state were not included at FAP as having no post-baseline data in the corresponding state or having no data in the corresponding state at Week 52/withdrawal.|Baseline, Week 52, and FAP (up to Week 52)|"FAS. Participants without off state at baseline were not included in the analysis of baseline off state data. Participants not included at FAP as well as those prematurely withdrawn from the study were not included at Week 52."||participants|||Number
742650|NCT00485069|Secondary|Mean Percent Change From Baseline in the Japanese UPDRS Part IV Total Score at Week 52 and FAP|The Japanese UPDRS assesses the status of PD patients objectively. Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications. Percent change from baseline was calculated as (change from baseline score/baseline score) * 100; change from baseline was calculated as thescore at the observation day minus the baseline score.|Baseline, Week 52, and FAP (up to Week 52)|FAS. LOCF was used for the FAP data to impute post-baseline missing values. Some participants were not included at FAP as having a baseline value of zero, which could not be used for calculating the percent change, or having no post-baseline data. These participants as well as those prematurely withdrawn from the study were not included at Week 52.||percent change in score||Standard Deviation|Mean
742651|NCT00485069|Secondary|Japanese UPDRS Part IV Mean Total Score at Baseline, Week 52, and FAP|The Japanese UPDRS assesses the status of PD patients objectively. Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications.|Baseline, Week 52, and FAP (up to Week 52)|FAS. LOCF was used for the FAP data to impute post-baseline missing values. One participant was not included in the ROP+L-dopa group at FAP as having no post-baseline data. This participant as well as those prematurely withdrawn from the study in each group was not included at Week 52.||units on a scale||Standard Deviation|Mean
742652|NCT00485069|Secondary|"Mean Percent Change From Baseline in the Japanese UPDRS Part III Total Score (in On State for the ROP+L-Dopa Group) at Week 52 and FAP"|"The Japanese UPDRS assesses the status of PD patients objectively. Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. On state is where PD symptoms are well controlled by the drug. Percent change from baseline was calculated as (change from baseline score/baseline score) * 100; change from baseline was calculated as thescore at the observation day minus the baseline score."|Baseline, Week 52, and FAP (up to Week 52)|"FAS. LOCF was used for the FAP data to impute post-baseline missing values. Participants with off state at baseline or without post-baseline data were not included in the ROP+L-dopa group at FAP. These participants as well as one with off state at Week 52 in that group and those prematurely withdrawn in each group were not included at Week 52."||percent change in score||Standard Deviation|Mean
742653|NCT00485069|Secondary|"Japanese UPDRS Part III Mean Total Score (in On State for the ROP+L-Dopa Group) at Baseline, Week 52, and FAP"|"The Japanese UPDRS assesses the status of PD patients objectively. Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. On state is where PD symptoms are well controlled by the drug. LOCF was used for the FAP data to impute post-baseline missing values. One participant was not included in the ROP+L-dopa group at FAP as having no post-baseline data."|Baseline, Week 52, and FAP (up to Week 52)|"FAS. Participants having off state at baseline were not included in the ROP+L-dopa group at baseline. The participant not included in the FAP as well as one having off state in the ROP+L-dopa group at Week 52 and those prematurely withdrawn in each group were not included at Week 52."||units on a scale||Standard Deviation|Mean
744126|NCT00506662|Secondary|Change in Glycosylated Haemoglobin (HbA1c) at Month 4||week 0, month 4|Due to the recruitment issue, the trial has been prematurely interrupted and the final number of patients does not allow any efficacy analysis.|||||
742654|NCT00485069|Secondary|Mean Percent Change From Baseline in the Japanese UPDRS Part II Total Score at Week 52 and FAP in the ROP Group|The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. Percent change from baseline was calculated as (change from baseline score/baseline score) * 100; change from baseline was calculated as thescore at the observation day minus the baseline score.|Baseline, Week 52, and FAP (up to Week 52)|FAS. LOCF was used for the FAP data to impute post-baseline missing values. Some participants were not included at FAP as having a baseline value of zero, which could not be used for calculating the percent change. These participants as well as those prematurely withdrawn were not included at Week 52||percent change in score||Standard Deviation|Mean
742655|NCT00485069|Secondary|"Mean Percent Change From Baseline in the Japanese UPDRS Part II Total Score at Week 52 and FAP by On/Off State in the ROP+L-Dopa Group"|"The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. On state is where PD symptoms are well controlled by the drug. Off state is where PD symptoms are not adequately controlled by the drug. Percent change from baseline was calculated as (change from baseline score/baseline score) * 100; change from baseline was calculated as thescore at the observation day minus the baseline score."|Baseline, Week 52, and FAP (up to Week 52)|"FAS. LOCF was used for FAP data. Some participants were not included at FAP as having a baseline value of zero, having no post-baseline data in on state, not having off state at baseline in off state, or having no data at Week 52/withdrawal in off state. These participants as well as those prematurely withdrawn were not included at Week 52."||percent change in score||Standard Deviation|Mean
742656|NCT00485069|Secondary|Japanese UPDRS Part II Mean Total Score at Baseline, Week 52, and FAP in ROP Group|The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms.|Baseline, Week 52, and FAP (up to Week 52)|FAS. LOCF was used for the FAP data to impute post-baseline missing values. Participants prematurely withdrawn from the study were not included at Week 52.||units on a scale||Standard Deviation|Mean
742657|NCT00485069|Secondary|"Japanese UPDRS Part II Mean Total Score at Baseline, Week 52, and FAP by On/Off State in the ROP+L-Dopa Group"|"The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. On state is where PD symptoms are well controlled by the drug. Off state is where PD symptoms are not adequately controlled by the drug. LOCF was used for the FAP data. Some participants were not included at FAP as having no post-baseline data in on state or having no data in off state at Week 52/withdrawal."|Baseline, Week 52, and FAP (up to Week 52)|"FAS. Participants without off state at baseline were not included in the analysis of baseline off state data. Participants not included at FAP as well as those prematurely withdrawn from the study were not included at Week 52."||units on a scale||Standard Deviation|Mean
742658|NCT00485069|Secondary|Mean Percent Change From Baseline in the Japanese UPDRS Part I Total Score at Week 52 and FAP|The Japanese UPDRS assesses the status of PD patients objectively. Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms. Percent change from baseline was calculated as (change from baseline score/baseline score) * 100; change from baseline was calculated as thescore at the observation day minus the baseline score.|Baseline, Week 52, and FAP (up to Week 52)|FAS. LOCF was used for the FAP data to impute post-baseline missing values. Some participants were not included at FAP as having a baseline value of zero, which could not be used for calculating the percent change, or having no post-baseline data. These participants as well as those prematurely withdrawn in each group were not included at Week 52.||percent change in score||Standard Deviation|Mean
742659|NCT00485069|Secondary|Japanese UPDRS Part I Mean Total Score at Baseline, Week 52, and FAP|The Japanese UPDRS assesses the status of PD patients objectively. Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms.|Baseline, Week 52, and FAP (up to Week 52)|FAS. LOCF was used for the FAP data to impute post-baseline missing values. One participant was not included in the ROP+L-dopa group at FAP as having no post-baseline data. This participant as well as those prematurely withdrawn from the study in each group was not included at Week 52.||units on a scale||Standard Deviation|Mean
742660|NCT00485069|Secondary|Mean Change From Baseline in the Japanese UPDRS Part IV Total Score at Week 52 and FAP|The Japanese UPDRS assesses the status of PD patients objectively. Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications.|Baseline, Week 52, and FAP (up to Week 52)|FAS. LOCF was used for the FAP data to impute post-baseline missing values. One participant was not included in the ROP+L-dopa group at FAP as having no post-baseline data. This participant as well as those prematurely withdrawn from the study in each group was not included at Week 52.||units on a scale||Standard Deviation|Mean
742661|NCT00485069|Secondary|Mean Change From Baseline in the Japanese UPDRS Part II Total Score at Week 52 and FAP in the ROP Group|The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms.|Baseline, Week 52, and FAP (up to Week 52)|FAS. LOCF was used for the FAP data to impute post-baseline missing values. Participants prematurely withdrawn from the study were not included at Week 52.||units on a scale||Standard Deviation|Mean
742679|NCT00485173|Secondary|Arm Pain Success Rate|Arm pain success rate is reported as the percentage of participants whose arm pain improvement met: Preoperative Score - Postoperative Score > 0.|24 months post-operation|Primary dataset.||percentage of participants|||Number
743256|NCT00496262|Secondary|Terminal Elimination Half-life (t1/2)|t1/2 for fibrinogen activity was determined from samples taken at 12 timepoints during the specified time frame.|0.5 hours to 13 days post-infusion|The pharmacokinetic analysis population (PK PP) included all subjects who received >90% of the infusion and who also had sufficient data for a reliable PK analysis (n=14).||hours||Standard Deviation|Mean
742662|NCT00485069|Secondary|"Mean Change From Baseline in the Japanese UPDRS Part II Total Score at Week 52 and FAP by On/Off State in the ROP+L-Dopa Group"|"The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. On state is where PD symptoms are well controlled by the drug. Off state is where PD symptoms are not adequately controlled by the drug."|Baseline, Week 52, and FAP (up to Week 52)|"FAS. LOCF was used for the FAP data to impute post-baseline missing values. Some participants were not included at FAP as having no post-baseline data in on state, not having off state at baseline, or no data in off state at Week 52/withdrawal. These participants as well as those prematurely withdrawn were not included at Week 52."||units on a scale||Standard Deviation|Mean
742663|NCT00485069|Secondary|Mean Change From Baseline in the Japanese UPDRS Part I Total Score at Week 52 and FAP|The Japanese UPDRS assesses the status of PD patients objectively. Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms.|Baseline, Week 52, and FAP (up to Week 52)|FAS. LOCF was used for the FAP data to impute post-baseline missing values. One participant was not included in the ROP+L-dopa group at FAP as having no post-baseline data. This participant as well as those prematurely withdrawn from the study in each group was not included at Week 52.||units on a scale||Standard Deviation|Mean
742664|NCT00485069|Primary|"Mean Change From Baseline in the Japanese Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score (in On State for the ROP+L-Dopa Group) at Week 52 and Final Assessment Point (FAP)"|"The Japanese UPDRS assesses the status of Parkinson's Disease (PD) patients objectively. Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. On state is where PD symptoms are well controlled by the drug. Participants with off state at baseline or without post-baseline data were not included in the ROP+L-dopa group at FAP. These participants as well as one with off state at Week 52 and those prematurely withdrawn were not included at Week 52."|Baseline, Week 52, and FAP (up to Week 52)|Full Analysis Set (FAS): all participants enrolled in the Treatment Phase, excluding those with objective measurements not meeting the major eligibility criteria, who did not receive ROP at all, and those with no valid post-baseline data. Last observation carried forward (LOCF) was used for the FAP data to impute post-baseline missing values.||units on a scale||Standard Deviation|Mean
742665|NCT00485134|Secondary|Number of Subjects Exhibiting an Immune Response to Invaplex 50 and/or LPS|Immune responder is defined as someone with both a serologic and an ASC response to either Invaplex 50 or LPS. Immune response defined as Serology: ≥ 4-fold increase in baseline serum titer antibody cecreting cells (ASC): ≥ 10 ASC per 106 peripheral blood mononuclear cells(PBMC).|56 days post-vaccination in stage 1|This analysis is limited to groups A-C only and subjects receiving at least 2 doses of S. flexneri 2a Invaplex 50 or LPS||participants|||Number
742666|NCT00485134|Secondary|S. Flexneri 2a Related Non-diarrheal Clinical Outcomes by Study Group||56 days post-challenge|||participants|||Number
742667|NCT00485134|Secondary|Post-challenge Loose Stool Sample Durations by Study Group||7 days after challenge|One subject in each group had diarrhea continuing at discharge so measured stool output likely an underestimate.||hours||Full Range|Mean
742668|NCT00485134|Secondary|Post-challenge Loose Stool Sample Volumes by Study Group||7 days after challenge|One subject in each group had diarrhea continuing at discharge so measured stool output likely an underestimate.||mL||Full Range|Mean
742669|NCT00485134|Secondary|Post-challenge Loose Stool Samples Occurrences by Study Group||7 days after challenge|One subject in each group had diarrhea continuing at discharge so measured stool output likely an underestimate.||loose stools||Full Range|Mean
742670|NCT00485134|Primary|Post-challenge Diarrhea, Fever, and Blood in Stool Adverse Events by Study Group|Fecal samples were collected through day 77 or until discharge (all stools collected for weighing/grading; maximum of 3 stools/day for culture; rectal swab obtained if no stool provided).|7 days after challenge|The decision criteria to progress to challenge with the Shigella challenge strain were no limiting adverse events (AEs) and positive immune response. These individuals were challenged with 800 colony forming units (CFU) of Shigella challenge strain, Shigella flexneri 2a strain 2457T.||participants|||Number
742671|NCT00485173|Other Pre-specified|Ossification in the Region of Target Level|Ossification in the region of target level is reported as the percentage of the patients who had ossification in the region of the target level. The region of target level included the index level, the superior and inferior adjacent disc spaces, and the superior and inferior adjacent vertebral bodies.|24 months post-operation|Primary dataset.||percentage of participants|||Number
742672|NCT00485173|Secondary|Number of Patients Who Had Secondary Surgeries at the Index Level|Secondary surgical procedures at the index level included revisions, removal, supplemental fixation and reoperations.|24 months post-operation|||participants|||Number
742673|NCT00485173|Secondary|Hospital Stay||During the time of hospital stay, average of 1 day.|Primary dataset.||days||Standard Deviation|Mean
742674|NCT00485173|Secondary|Blood Loss||During the time of operation, approximately 1.5 hours.|Primary dataset.||ml||Standard Deviation|Mean
742675|NCT00485173|Secondary|Operative Time|Operative time was recorded from skin incision to wound closure.|Time of operation, approximately 1.5 hrs.|Primary dataset.||hrs||Standard Deviation|Mean
742676|NCT00485173|Secondary|Success Rate of SF-36 MCS|Success rate of SF-36 Health Survey include two components: the success rate of a physical component summary (PCS) and the success rate of a mental component summary (MCS). The success rates of SF-36 MCS were defined as: Post Score - Pre Score >= 0.|24 months post-operation|Primary dataset.||percentage of participants|||Number
742677|NCT00485173|Secondary|Success Rate of SF-36 PCS|Success rate of SF-36 Health Survey include two components: the success rate of a physical component summary (PCS) and the success rate of a mental component summary (MCS). The success rate of SF-36 PCS was defined as: Post Score - Pre Score >= 0.|24 months post-operation|Primary dataset.||percentage of participants|||Number
742678|NCT00485173|Other Pre-specified|General Health Status -- SF-36 MCS|The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results are summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for MCS is between 0 and 100, with higher scores denoting better quality of life.|24 months post-operation|Primary dataset.||units on a scale||Standard Deviation|Mean
742680|NCT00485173|Other Pre-specified|General Health Status -- SF-36 PCS|The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results are summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS is between 0 and 100, with higher scores denoting better quality of life.|24 months post-operation|Primary dataset.||units on a scale||Standard Deviation|Mean
742681|NCT00485173|Secondary|Neck Pain Success Rate|Neck pain success rate is reported as the percentage of participants whose neck pain improvement met: Preoperative Score - Postoperative Score > 0.|24 months post-operation|Primary dataset.||percentage of participants|||Number
742682|NCT00485173|Other Pre-specified|Arm Pain Score|"Numerical rating scales are used to evaluate arm pain intensity and frequency. Patients rate their arm pain intensity on a scale from 0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be. Similarly, patients record their arm pain frequency on a scale from 0-10, with a score of 0 being pain none of the time and a score of 10 being pain all of the time. The total arm pain score will be the sum of pain intensity and frequency scores."|24 months post-operation|Primary dataset.||units on a scale||Standard Deviation|Mean
742683|NCT00485173|Secondary|Success Rate of Neurological Status|Success rate of neurological status is reported as the percentage of participants who met neurological success defined as maintenance or improvement in all sections (motor, sensory, and reflexes) for the time period evaluated. In order for a section to be considered a success, each element in the section must remain the same or improve from the time of the preoperative evaluation to the time period evaluated.|24 months post-operation|Primary dataset.||percentage of participants|||Number
742684|NCT00485173|Other Pre-specified|Neck Pain Score|"Numerical rating scales are used to evaluate neck pain intensity and frequency. Patients rate their neck pain intensity on a scale from 0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be. Similarly, patients record their neck pain frequency on a scale from 0-10, with a score of 0 being pain none of the time and a score of 10 being pain all of the time. The total neck pain score is the sum of pain intensity and frequency scores."|24 months post-operation|Primary dataset.||units on a scale||Standard Deviation|Mean
742685|NCT00485173|Secondary|Success Rate of Neck Disability Index|Success rate of Neck Disability Index is reported as the percentage of participants whose neck disability index score met: Pre-treatment Score - Post-treatment Score ≥ 15.|24 months post-operation|Primary dataset.||percentage of participants|||Number
742686|NCT00485173|Other Pre-specified|Neck Disability Index Score|The self-administered Neck Disability Index (NDI) Questionnaire was used to assess patient neck pain and ability to function. The NDI scale ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability).|24 months post-operation|Primary dataset.||units on a scale||Standard Deviation|Mean
742687|NCT00485173|Secondary|Success Rate of Fusion|"Success Rate of Fusion is reported as percent of participants who met the following fusion criteria:
Evidence of bridging bone. This is based on the evidence of a continuous bony connection from the superior vertebral body to the inferior vertebral body in at least one of the following areas: lateral, anterior, posterior and/or through the PEEK spacer.
No evidence of radiolucency at greater than 50% of the superior or inferior PEEK spacer-vertebra interface.
No evidence of motion as defined by ≤ 4º of angular motion (based on flexion-extension lateral plain radiographs)."|24 months post-operation|Primary dataset.||percentage of participants|||Number
742688|NCT00485173|Primary|Rate of Overall Success|"Rate of overall success is reported as the percentage of participants who met all of the following criteria:
fusion at the treated level;
pain/disability (Neck Disability Index) success;
neurological status success;
no serious adverse event classified as “implant associated” or “implant/surgical procedure associated;”
no additional surgical procedure classified as a “failure.”"|24 months post-operation|Primary dataset (including all subjects who received study devices. Missing observations were not imputed.)||percentage of participants|||Number
742689|NCT00485264|Secondary|Change of CD4 Percent From Baseline||Baseline, Week 24, 48|Final Dose Population: Participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts are combined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts.||percentage of total lymphocytes||95% Confidence Interval|Mean
742690|NCT00485264|Secondary|Change of CD4 Count (Cells/µL) From Baseline||Baseline, Week 24, 48|Final Dose Population: Participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts are combined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts.||cells/µL||95% Confidence Interval|Mean
742691|NCT00485264|Secondary|Percentage of Participants With ≥1 log10 Drop From Baseline in HIV RNA or HIV RNA <400 Copies/mL|Plasma HIV RNA (RNA) concentrations were determined at entry and at regular intervals using the HIV-1 MONITOR Test, version 1.5 (Roche Molecular Diagnostics) or RealTime HIV-1 (Abbott Molecular).|Baseline, Week 24, 48|Final Dose Population: Participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts are combined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts.||percentage of participants||95% Confidence Interval|Number
742692|NCT00485264|Secondary|Number of Participants Who Died||From study entry through Week 48|Final Dose Population: Participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts are combined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts.||participants|||Number
742693|NCT00485264|Secondary|Number of Participants Terminated From Treatment Due to Suspected Adverse Drug Reaction (SADR) Attributable to the Study Medication|The attribution of relationship of serious adverse events to study drug for the purposes of employing the start, stop and pause rules was by consensus among the site investigator, study team (which includes representatives from Merck) and the Division of AIDS medical officer; if unanimous agreement between them cannot be established, the attribution made by the majority of these 3 persons or entities will be used. Gradation of relationship will use the following terminology: Not related, Probably not related, Possibly related, Probably related or Definitely related.|From study entry through Week 48|Final Dose Population: Participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts are combined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts.||participants|||Number
774525|NCT00748969|Secondary|Change in Mobility Measured by Force and Gait Measurements.||12 months||||||
742694|NCT00485264|Secondary|Percentage of Participants With Grade 3 or 4 Adverse Events (AEs)|Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004, Clarification August 2009, which is available on the RCC website at (http://rcc.tech-res.com/). All grade 3 and higher signs, symptoms, and laboratory toxicities were included.|From study entry through Week 48|Final Dose Population: Participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts are combined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts.||percentage of participants||95% Confidence Interval|Number
742695|NCT00485264|Primary|PK Parameter: Concentration at 12 Hours Postdose (C12h)|Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods (WinNonlin version 4.01, Pharsight Corp., Mountain View, CA). Plasma concentration at 12 hours postdose (C12h) was taken directly from the observed concentration-time data.|Measured between days 5 and 12 of raltegravir initiation; Blood samples were drawn pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, and 12 hours post dosing.|Participants with intensive pharmacokinetic (PK) results at the final recommended dose (Stage I). Cohorts IV and V were not included in this interim analysis.||ng/mL||Standard Deviation|Mean
742696|NCT00485264|Primary|PK Parameter: Time to Half of Maximum Plasma Concentration Cmax (T1/2)|Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods (WinNonlin version 4.01, Pharsight Corp., Mountain View, CA). Time to half of maximum plasma concentration Cmax (T1/2) was taken directly from the observed concentration-time data.|Measured between days 5 and 12 of raltegravir initiation; Blood samples were drawn pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, and 12 hours post dosing.|Participants with intensive pharmacokinetic (PK) results at the final recommended dose (Stage I). Cohorts IV and V were not included in this interim analysis.||hour||Standard Deviation|Mean
742697|NCT00485264|Primary|PK Parameter: Maximum Plasma Concentration (Cmax)|Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods (WinNonlin version 4.01, Pharsight Corp., Mountain View, CA). Maximum plasma concentration (Cmax) was taken directly from the observed concentration-time data.|Measured between days 5 and 12 of raltegravir initiation; Blood samples were drawn pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, and 12 hours post dosing.|Participants with intensive pharmacokinetic (PK) results at the final recommended dose (Stage I). Cohorts IV and V were not included in this interim analysis.||ng/mL||Standard Deviation|Mean
742698|NCT00485264|Primary|Pharmacokinetic (PK) Parameter: Area Under the Curve (AUC12h)|Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods (WinNonlin version 4.01, Pharsight Corp., Mountain View, CA). AUC12h (area-under-the-curve from 0 to 12 hours) were determined using the linear-log trapezoidal rule.|Measured between days 5 and 12 of raltegravir initiation; Blood samples were drawn pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, and 12 hours post dosing.|Participants with intensive pharmacokinetic (PK) results at the final recommended dose (Stage I). Cohorts IV and V were not included in this interim analysis.||hour*mg/L||Standard Deviation|Mean
742699|NCT00485264|Primary|Number of Participants Who Died||From study entry through Week 24|Final Dose Population: Participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts are combined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts.||participants|||Number
742700|NCT00485264|Primary|Number of Participants Terminated From Treatment Due to Suspected Adverse Drug Reaction (SADR) Attributable to the Study Medication|The attribution of relationship of serious adverse events to study drug for the purposes of employing the start, stop and pause rules was by consensus among the site investigator, study team (which includes representatives from Merck) and the Division of AIDS medical officer; if unanimous agreement between them cannot be established, the attribution made by the majority of these 3 persons or entities will be used. Gradation of relationship will use the following terminology: Not related, Probably not related, Possibly related, Probably related or Definitely related.|From study entry through Week 24|Final Dose Population: Participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts are combined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts.||participants|||Number
742701|NCT00485264|Primary|Percentage of Participants With Grade 3 or 4 Adverse Events (AEs)|Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004, Clarification August 2009, which is available on the RCC website at (http://rcc.tech-res.com/). All grade 3 and higher signs, symptoms, and laboratory toxicities were included.|From study entry through Week 24|Final Dose Population: Participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts are combined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts.||percentage of participants||95% Confidence Interval|Number
742702|NCT00485303|Secondary|Percentage of Participants With Clinical Benefit|Clinical benefit was defined as an observation of at least 1 of the following: PSA response by PSAWG criteria; radiographic response by RECIST criteria; stable disease by RECIST criteria lasting 6 months; or improvement by at least 1 unit in ECOG performance status.|Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 60 months|Per protocol population defined as participants who had received at least one dose of abiraterone acetate and must had PSA evaluation/tumor assessment at Baseline and at least 1 post-baseline, and had received a minimum of 3 cycles of study treatment.||percentage of participants|||Number
742713|NCT00485472|Secondary|Change From Baseline to End of 8 Week Maintenance Period in Profile of Mood States (Total Mood Disturbance Score).|Total Mood Disturbance score sums up over the domain scores regarding Tension-anxiety, Depression-ejection, Anger-hostility, Vigor-activity (was subtracted), Fatigue-inertia, Confusion-bewilderment. Domain scores were derived as sum of the respective items and range from 0 to 20. With exception of Vigor-activity high values describe bad mood.|Baseline, end of 8 week Maintenance Period|Full Analysis Set (FAS), defined as all randomized subjects that have received at least one dose of trial medication and had at least one post-baseline WOMAC assessment. Only subjects with non-missing values were included.||Unit on a scale||Standard Deviation|Mean
744127|NCT00506662|Primary|Change in Glycosylated Haemoglobin (HbA1c) at Month 7||week 0, month 7|Due to the recruitment issue, the trial has been prematurely interrupted and the final number of patients does not allow any efficacy analysis.|||||
742703|NCT00485303|Secondary|Shift From Baseline in Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score|ECOG performance status score ranges from 0 to 5 where 0=fully active, perform all pre-disease activities without restriction. 1=restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature, 2=ambulatory, capable of self-care, unable to carry out any work activities, up and about more than (>) 50 percent of waking hours, 3=capable of limited self-care, confined to bed or chair >50 percent of waking hours, 4=completely disabled, not capable of any self-care, totally confined to bed or chair and 5=dead.|Baseline and Day 1 of each cycle until first documented disease progression or up to 60 months|Per protocol population defined as participants who had received at least one dose of abiraterone acetate and must had PSA evaluation/tumor assessment at Baseline and at least 1 post-baseline, and had received a minimum of 3 cycles of study treatment. 'N' (number of participants analyzed) = participants who were evaluable for this measure.||participants|||Number
742704|NCT00485303|Secondary|Time to Radiographic Progression|Time to radiographic progression is defined as the time from first dose until the first radiographic progression date that was confirmed.|Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 60 months|Per protocol population defined as participants who had received at least one dose of abiraterone acetate and must had PSA evaluation/tumor assessment at Baseline and at least 1 post-baseline, and had received a minimum of 3 cycles of study treatment.||days||95% Confidence Interval|Median
742705|NCT00485303|Secondary|Time to PSA Progression|The time interval from first dose of abiraterone acetate to the date of PSA progression as defined by the Prostate-Specific Antigen Working Group (PSAWG) criteria. If a PSA progression does not occur, subject will be censored at the last PSA evaluation.|Day 8 of Cycle 1, thereafter Day 1 of each cycle up to end of study (60 months)|Per protocol population defined as participants who had received at least one dose of abiraterone acetate and must had PSA evaluation/tumor assessment at Baseline and at least 1 post-baseline, and had received a minimum of 3 cycles of study treatment.||days||95% Confidence Interval|Median
742706|NCT00485303|Secondary|Percentage of Participants With Objective Radiographic Response|Percentage of participants with radiographic objective response is defined as the percentage of participants with complete response (CR) or partial response (PR) as best overall response based on reconciled radiographic disease assessment according to RECIST Version 1.0. The CR is disappearance of all lesions. The PR is at least 30 percent decrease in sum of the longest diameter of target lesions or persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.|Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 60 months|Per protocol population defined as participants who had received at least 1 dose of abiraterone acetate and must had PSA evaluation/tumor assessment at Baseline and at least 1 post-baseline, and had received a minimum of 3 cycles of study treatment. “N” (number of participants analyzed) =participants who were evaluable for this measure.||percentage of participants|||Number
742707|NCT00485303|Secondary|Overall Survival (OS)|Overall survival is defined as the interval from the date of the first dose of abiraterone acetate to the date of death.|Every 3 months until death or up to 60 months|Per protocol population defined as participants who had received at least one dose of abiraterone acetate and must had PSA evaluation/tumor assessment at Baseline and at least 1 post-baseline, and had received a minimum of 3 cycles of study treatment.||days||95% Confidence Interval|Median
742708|NCT00485303|Secondary|Radiographic Progression Free Survival (PFS)|The RAD-PFS is defined as the time from randomization to the earliest objective evidence of radiographic progression or death due to any cause. Progression is defined using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0, as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.|Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 60 months|||days||95% Confidence Interval|Median
742709|NCT00485303|Secondary|Prostate-Specific Antigen Based Progression-free Survival (PSA-PFS)|The PSA-PFS is defined as time to first PSA failure (that is, two consecutive increases in PSA of 50 percent and greater than or equal to 5 nanogram per milliliter, as per Prostate-Specific Antigen Working Group [PSAWG] criterion) or death or the start of secondary anti-tumor therapy, whichever occurs first. If a PSA progression or death does not occur, subject will be censored at the last PSA evaluation.|Baseline and Day 1 of each cycle until first documented disease progression or up to 60 months|Per protocol population defined as participants who had received at least one dose of abiraterone acetate and must had PSA evaluation/tumor assessment at Baseline and at least 1 post-baseline, and had received a minimum of 3 cycles of study treatment.||days||95% Confidence Interval|Median
742710|NCT00485303|Primary|Percentage of Participants With Prostate Specific Antigen (PSA) Response|The PSA response was evaluated according to Prostate-Specific Antigen Working Group (PSAWG) criterion, which is, greater than or equal to 50 percent decrease in PSA from Baseline during the study, which would be subsequently confirmed by a measurement that is at least 4 or more weeks after initial documentation of PSA response.|Day 1 of each cycle (of 28 days each) up to Cycle 12|Per protocol population defined as participants who had received at least one dose of abiraterone acetate and must had PSA evaluation/tumor assessment at Baseline and at least 1 post-baseline, and had received a minimum of 3 cycles of study treatment.||percentage of participants||95% Confidence Interval|Number
742711|NCT00485433|Secondary|Number of Participants With Adverse Events Through 96 Hours or Serious Adverse Events Through 30 Days||Up to 30 days||||||
742712|NCT00485433|Primary|Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) With Activity (NRS-A) Pain Intensity Scores From 0 Through 72 Hours|The subject’s pain intensity was to be assessed with activity (NRS-A), after the subject had moved himself from a supine position in bed to a sitting up position at the edge of the bed. The subject was to respond to the following question: “On a scale of 0 to 10, where 0=no pain and 10=worst possible pain, how much pain did you have while sitting up?”|0 to 72 hours|||Units on a scale*hours||Standard Deviation|Mean
742764|NCT00486954|Secondary|Time to Cmax (Tmax) of Lapatinib in the Pilot Part of the Study|PK samples were collected at pre-dose and at 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Days 8 and 14.|Days 8 and 14|PK Parameter Population||hours (hr)||Full Range|Median
747087|NCT00527566|Primary|Number of Participants Who Experienced Specific Symptoms|Number of participants who experienced specific symptoms during the trial.|44 weeks|||Participants|||Number
742714|NCT00485472|Secondary|Change From Baseline to End of 8 Week Maintenance Period in Perception of Pain Interference With Subject’s Sleep.|Pain interference with sleep refers to patient's last evening prior to the visit and was assessed using a 100mm visual analog scale (VAS). The VAS ranges from 0 (did not interfere) to 100 (completely interfered).|Baseline, end of 8 week Maintenance Period|Full Analysis Set (FAS), defined as all randomized subjects that have received at least one dose of trial medication and had at least one post-baseline WOMAC assessment. Only subjects with non-missing values were included.||Unit on a scale||Standard Deviation|Mean
742715|NCT00485472|Secondary|Amount of Rescue Medication Use During 8 Week Maintenance Period.|Use of rescue medication is expressed in number of tablets equivalent to 500 mg Paracetamol per day.|during 8 week Maintenance Period|Full Analysis Set (FAS), defined as all randomized subjects that have received at least one dose of trial medication and had at least one post-baseline WOMAC assessment. Only subjects who entered the Maintenance Phase were included.||tablets/day||Standard Deviation|Mean
742716|NCT00485472|Secondary|Response at the End of 8 Week Maintenance Period Versus Baseline Based on the (Slightly Modified)Criteria of the Osteoarthritis Research Society International (OARSI) and the Outcome Measures in Rheumatology Initiative (OMERACT).|Improvement = reduction of >= 20% and >= 10 mm in both WOMAC pain and physical function subscale. Those who met the criteria in either of the subscales had improved if response to Patient's Global Impression of change from baseline was at least 'mildly improved'. High improvement = reduction of >= 50% and >= 20 mm in either of the subscales. Response = either high improvement or improvement.|Baseline, end of 8 week Maintenance Period|Full Analysis Set (FAS), defined as all randomized subjects that have received at least one dose of trial medication and had at least one post-baseline WOMAC assessment. Dropouts due to lack of efficay were defined as non-responders. For dropouts due to any other reason LOCF was applied to the underlying WOMAC subscale scores.||participants|||Number
742717|NCT00485472|Secondary|Patient’s Global Impression of Change From Baseline at the End of 8 Week Maintenance Period.|Patient's global impression of change from baseline is a score that ranges from 'very much worse' to 'very much improved'.|at the end of 8 week Maintenance Period|Full Analysis Set (FAS), defined as all randomized subjects that have received at least one dose of trial medication and had at least one post-baseline WOMAC assessment. Only subjects with non-missing measurements of Patient's global impression of change from baseline were included.||Participants|||Number
742718|NCT00485472|Secondary|Change From Baseline to End of 8 Week Maintenance Period in Total WOMAC Score.|The WOMAC total score is the sum of the normalized subscale scores for pain, stiffness, and physical function and ranges from 0 to 300, high values describe high grade of impact.|Baseline, end of 8 week Maintenance Period|Full Analysis Set (FAS), defined as all randomized subjects that have received at least one dose of trial medication and had at least one post-baseline WOMAC assessment. LOCF imputation method was applied in case of missing WOMAC assessment.||Unit on a scale||Standard Deviation|Mean
742719|NCT00485472|Secondary|Change From Baseline to End of 8 Week Maintenance Period in WOMAC Stiffness Subscale Score.|The WOMAC stiffness subscale score (Visual Analogue Scale version) ranges from 0 to 100, high values describe high grade of stiffness.|Baseline, end of 8 week Maintenance Period|Full Analysis Set (FAS), defined as all randomized subjects that have received at least one dose of trial medication and had at least one post-baseline WOMAC assessment. LOCF imputation method was applied in case of missing WOMAC assessment.||Unit on a scale||Standard Deviation|Mean
742720|NCT00485472|Secondary|Change From Baseline to End of 8 Week Maintenance Period in WOMAC Physical Function Subscale Score.|The WOMAC physical function subscale score (Visual Analogue Scale version) ranges from 0 to 100, high values describe high grade of difficulty in performing daily activities.|Baseline, end of 8 week Maintenance Period|Full Analysis Set (FAS), defined as all randomized subjects that have received at least one dose of trial medication and had at least one post-baseline WOMAC assessment. LOCF imputation method was applied in case of missing WOMAC assessment.||Unit on a scale||Standard Deviation|Mean
742721|NCT00485472|Primary|Change of the Western Ontario and McMaster Universities (WOMAC) Pain Subscale Score (Visual Analogue Scale Version) From Baseline to the End of the 8 Week Maintenance Period|The Visual Analogue Scale (VAS) version of the WOMAC pain subscale ranges from 0 to 100, high values describe high grade of pain.|Baseline, end of 8 week Maintenance Period|Full Analysis Set (FAS), defined as all randomized subjects that have received at least one dose of trial medication and had at least one post-baseline WOMAC assessment. Last observation carried forward (LOCF) imputation method was applied in case of missing WOMAC assessment.||Unit on a scale||Standard Deviation|Mean
742722|NCT00485485|Primary|Participant Response Rate|Response rate to regimen defined as the number of complete or partial response divided by the total number of participants treated. Tumor response defined by Response Evaluation Criteria In Solid Tumors (RECIST). All complete and partial responses confirmed by a second assessment six weeks later.|At 6 weeks reconfirmed 6 weeks later|||Participants|||Number
742723|NCT00486954|Secondary|Number of Participants With Mutations That May Correlate With Response and Toxicity to Lapatinib|An inadequate number of tissue samples were obtained; thus, analysis could not be performed.|Pretreatment|ITT Population|||||
742724|NCT00486954|Secondary|Number of Participants With the Indicated Human Epidermal Growth Factor Receptor 2 (HER2) Immunohistochemistry Intensity in the Randomized Part of the Study|"HER2 protein expression on the surface of cells in gastric cancer tissue samples was measured using a monoclonal antibody specific for the extracellulr region of HER2, and the degree of membrane staining was evaulated. The immunohistochemistry test gives a score of 0 to 3+ and measures the amount of HER2 receptor protein on the surface of cells in a gastric cancer tissue sample. Score of 0 to 1+, HER2 negative; score of 2+, borderline; score of 3+, HER2 positive."|Pretreatment|ITT Population. Only those participants for whom immunohistochemistry testing was conducted were analyzed.||participants|||Number
742725|NCT00486954|Secondary|Number of Participants With the Indicated Epidermal Growth Factor Receptor (EGFR) Immunohistochemistry Intensity in the Randomized Part of the Study|EGFR protein expression on the surface of cells in gastric cancer tissue samples was measured using a moncolonal antibody specific for the extracellular region of EGFR, and the degree of membrane staining was evaluated. 3+ indicates positive EGFR expression; <3+ indicates negative EGFR expression.|Pretreatment|ITT Population. Only those participants for whom immunohistochemistry testing was conducted were analyzed.||participants|||Number
744995|NCT00511667|Secondary|Concentration of MK-0941 at 24 Hours (C24hr) After Multiple Doses of MK-0941||Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day)|||nM||Standard Deviation|Mean
742726|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-STO22 Hair Loss Scale Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-STO22 is a 22-item, self-reporting instrument consisting of 5 scales and 4 single items to assess health-related quality of life (HRQOL) issues related to dysphagia, eating restrictions, reflux, and abdominal pain, as well as specific symptoms that may occur during chemotherapy or radiation treatment. Scores are averaged and transformed to a 0-100 scale. For the symptom scales and items, a high score is equivalent to worse or more symptoms. In the functional scales, however, a high score is equivalent to better function.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.||scores on a scale||Standard Deviation|Mean
742727|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-STO22 Body Image Scale Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-STO22 is a 22-item, self-reporting instrument consisting of 5 scales and 4 single items to assess health-related quality of life (HRQOL) issues related to dysphagia, eating restrictions, reflux, and abdominal pain, as well as specific symptoms that may occur during chemotherapy or radiation treatment. Scores are averaged and transformed to a 0-100 scale. For the symptom scales and items, a high score is equivalent to worse or more symptoms. In the functional scales, however, a high score is equivalent to better function.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.||scores on a scale||Standard Deviation|Mean
742728|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-STO22 Taste Scale Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-STO22 is a 22-item, self-reporting instrument consisting of 5 scales and 4 single items to assess health-related quality of life (HRQOL) issues related to dysphagia, eating restrictions, reflux, and abdominal pain, as well as specific symptoms that may occur during chemotherapy or radiation treatment. Scores are averaged and transformed to a 0-100 scale. For the symptom scales and items, a high score is equivalent to worse or more symptoms. In the functional scales, however, a high score is equivalent to better function.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.||scores on a scale||Standard Deviation|Mean
742729|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-STO22 Dry Mouth Scale Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-STO22 is a 22-item, self-reporting instrument consisting of 5 scales and 4 single items to assess health-related quality of life (HRQOL) issues related to dysphagia, eating restrictions, reflux, and abdominal pain, as well as specific symptoms that may occur during chemotherapy or radiation treatment. Scores are averaged and transformed to a 0-100 scale. For the symptom scales and items, a high score is equivalent to worse or more symptoms. In the functional scales, however, a high score is equivalent to better function.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.||scores on a scale||Standard Deviation|Mean
742730|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-STO22 Anxiety Scale Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-STO22 is a 22-item, self-reporting instrument consisting of 5 scales and 4 single items to assess health-related quality of life (HRQOL) issues related to dysphagia, eating restrictions, reflux, and abdominal pain, as well as specific symptoms that may occur during chemotherapy or radiation treatment. Scores are averaged and transformed to a 0-100 scale. For the symptom scales and items, a high score is equivalent to worse or more symptoms. In the functional scales, however, a high score is equivalent to better function.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.||scores on a scale||Standard Deviation|Mean
742731|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-STO22 Eating Restrictions Scale Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-STO22 is a 22-item, self-reporting instrument consisting of 5 scales and 4 single items to assess health-related quality of life (HRQOL) issues related to dysphagia, eating restrictions, reflux, and abdominal pain, as well as specific symptoms that may occur during chemotherapy or radiation treatment. Scores are averaged and transformed to a 0-100 scale. For the symptom scales and items, a high score is equivalent to worse or more symptoms. In the functional scales, however, a high score is equivalent to better function.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.||scores on a scale||Standard Deviation|Mean
742732|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-STO22 Reflux Symptoms Scale Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-STO22 is a 22-item, self-reporting instrument consisting of 5 scales and 4 single items to assess health-related quality of life (HRQOL) issues related to dysphagia, eating restrictions, reflux, and abdominal pain, as well as specific symptoms that may occur during chemotherapy or radiation treatment. Scores are averaged and transformed to a 0-100 scale. For the symptom scales and items, a high score is equivalent to worse or more symptoms. In the functional scales, however, a high score is equivalent to better function.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.||scores on a scale||Standard Deviation|Mean
742733|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-STO22 Pain Scale Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-STO22 is a 22-item, self-reporting instrument consisting of 5 scales and 4 single items to assess health-related quality of life (HRQOL) issues related to dysphagia, eating restrictions, reflux, and abdominal pain, as well as specific symptoms that may occur during chemotherapy or radiation treatment. Scores are averaged and transformed to a 0-100 scale. For the symptom scales and items, a high score is equivalent to worse or more symptoms. In the functional scales, however, a high score is equivalent to better function.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.||scores on a scale||Standard Deviation|Mean
742734|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-STO22 Dysphagia Scale Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-STO22 is a 22-item, self-reporting instrument consisting of 5 scales and 4 single items to assess health-related quality of life (HRQOL) issues related to dysphagia, eating restrictions, reflux, and abdominal pain, as well as specific symptoms that may occur during chemotherapy or radiation treatment. Scores are averaged and transformed to a 0-100 scale. For the symptom scales and items, a high score is equivalent to worse or more symptoms. In the functional scales, however, a high score is equivalent to better function.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.||scores on a scale||Standard Deviation|Mean
742735|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-C30 Financial Difficulties Symptom Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.||scores on a scale||Standard Deviation|Mean
742736|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-C30 Diarrhea Symptom Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.||scores on a scale||Standard Deviation|Mean
742737|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-C30 Constipation Symptom Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.||scores on a scale||Standard Deviation|Mean
742738|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-C30 Appetite Loss Symptom Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.||scores on a scale||Standard Deviation|Mean
742739|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-C30 Insomnia Symptom Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.||scores on a scale||Standard Deviation|Mean
742740|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-C30 Dyspnea Symptom Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.||scores on a scale||Standard Deviation|Mean
742741|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-C30 Pain Symptom Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.||scores on a scale||Standard Deviation|Mean
742742|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-C30 Nausea and Vomiting Symptom Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.||scores on a scale||Standard Deviation|Mean
742765|NCT00486954|Secondary|Maximum Plasma Concentration (Cmax) of Lapatinib in the Pilot Part of the Study|Pharmacokinetic (PK) samples were collected at pre-dose and at 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Days 8 and 14.|Days 8 and 14|PK Parameter Population: all participants for whom the PK parameter could be estimated||nanograms per milliliter (ng/mL)||95% Confidence Interval|Geometric Mean
742743|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-C30 Fatigue Symptom Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.||scores on a scale||Standard Deviation|Mean
742744|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-C30 Social Functioning Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.||scores on a scale||Standard Deviation|Mean
742745|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-C30 Cognitive Functioning Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.||scores on a scale||Standard Deviation|Mean
742746|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.||scores on a scale||Standard Deviation|Mean
742747|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-C30 Role Functioning Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.||scores on a scale||Standard Deviation|Mean
742748|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-C30 Physical Functioning Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.||scores on a scale||Standard Deviation|Mean
742749|NCT00486954|Secondary|Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life (QOL) Questionnaire (EORTC QLQ-C30) Global Health Status (GHS)/QOL Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.||scores on a scale||Standard Deviation|Mean
742750|NCT00486954|Secondary|Number of Participants With the Indicated Grade 3 and Grade 4 Adverse Events (AEs) for Which All Grades of the AE Were Reported in >=10% of Participants, Regardless of Causality in the Randomized Part of the Study|The Common Terminology Criteria for Advere Events (CTCAE) is a descriptive terminology that can be used for AE reporting. Grade (G) refers to the severity of the AE. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade (G) refers to the severity of the AE: G 1, mild AE; G 2, moderate AE; G 3, severe AE; G 4, life-threatening/disabling AE; G 5, death related to the AE.|From the first dose of investigational product to 30 days after the last dose (up to 110.3 weeks in the Randomized part)|Safety Population: all participants who were randomized and took at least one dose of study medication||participants|||Number
743951|NCT00504556|Primary|Percent of Subjects With Liver-related Laboratory Marked Abnormalities (MA)|liver enzyme (ALT and/or AST) and/or bilirubin (TBL) abnormalities|3 months|safety analysis set||percent subjects with liver related MA||95% Confidence Interval|Number
742751|NCT00486954|Secondary|Duration of Response in the Randomized Part of the Study|Duration of response was defined as the time from the first documented evidence of CR (the disappearance of all target lesions) or PR (a greater than 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD) until the first documented sign of disease progression (at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions) or death due to any cause, if sooner.|up to 18.27 months|ITT Population. Only those participants achieving a CR or PR were assessed.||months||95% Confidence Interval|Median
742752|NCT00486954|Secondary|Number of Participants With the Indicated Time to Response in the Randomized Part of the Study|Time to response was defined as the time from randomization to CR (the disappearance of all target lesions) or PR (a greater than 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD). For participants who did not achieve a CR or PR, time to response was censored at the last assessment prior to other cancer therapies. For censored participants, time to response was defined as the time from randomization to the time of the last assessment prior to the administation of other cancer therapies.|up to 5.62 months|ITT Population. Only those participants achieving a CR or PR were assessed.||Participants|||Number
742753|NCT00486954|Secondary|Percentage of Participants With Overall Response in the Randomized Part of the Study|Overall response was defined as the percentage of participants achieving either complete response (CR) or partial response (PR). Per RECIST, version 1.0, CR was defined as the disappearance of all target lesions, and PR was defined as a greater than 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.|From randomization up to 5.62 months|ITT Population||Percentage of participants|||Number
742754|NCT00486954|Secondary|Time to Progression in the Randomized Part of the Study|Time to progression was defined as the time from randomization until the earliest date of disease progression or death due to disease. Per RECIST, version 1.0, PD is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions.|From randomization until disease progression or death due to disease (up to 42.35 months )|ITT Population||months||95% Confidence Interval|Median
742755|NCT00486954|Secondary|Progression-free Survival (PFS) in the Randomized Part of the Study|PFS was defined as the time from randomization until the earliest date of disease progression (PD) or death due to any cause. Per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.0, PD is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions.|From randomization until disease progression or death due to any cause (up to 42.35 months)|ITT Population. For participants whose disease did not progress or who did not die, PFS was censored at the time of the last independently assessed radiological scan preceding the initiation of any alternate anti-cancer therapy.||months||95% Confidence Interval|Median
742756|NCT00486954|Secondary|Distribution Volume at Steady State (Vss) of Paclitaxel in the Pilot Part of the Study|PK samples were collected just before the start of infusion and 0.5, 1.0 (immediately before terminating the infusion), 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Days 1 and 8. Vss is the volume of distribution at steady state of paclitaxel.|Days 1 and 8|PK Parameter Population||liters per square meter||95% Confidence Interval|Geometric Mean
742757|NCT00486954|Secondary|Clearance of Paclitaxel in the Pilot Part of the Study|PK samples were collected just before the start of infusion and 0.5, 1.0 (immediately before terminating the infusion), 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Days 1 and 8. Clearance is defined as the clearance of drug from plasma, which is defined as the volume of plasma from which drug is removed per unit time.|Days 1 and 8|PK Parameter Population||liters per hour per square meter||95% Confidence Interval|Geometric Mean
742758|NCT00486954|Secondary|Half-life of Paclitaxel in the Pilot Part of the Study|PK samples were collected just before the start of infusion and 0.5, 1.0 (immediately before terminating the infusion), 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Days 1 and 8. Half-life is defined as the time required for the amount of the drug in the plasma to decrease by half.|Days 1 and 8|PK Parameter Population||hr||95% Confidence Interval|Geometric Mean
742759|NCT00486954|Secondary|Area Under the Concentration-time Curve From Time Zero to Infinity (AUC[0-inf]) of Paclitaxel in the Pilot Part of the Study|PK samples were collected just before the start of infusion and 0.5, 1.0 (immediately before terminating the infusion), 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Days 1 and 8. AUC is defined as the area under the paclitaxel concentration-time curve as a measure of drug exposure. AUC(0-inf) is area under the plasma concentration-time curve from the start of infusion (time 0) extrapolated to infinity.|Days 1 and 8|PK Parameter Population||hr*ng/mL||95% Confidence Interval|Geometric Mean
742760|NCT00486954|Secondary|AUC(0-24) of Paclitaxel in the Pilot Part of the Study|PK samples were collected just before the start of infusion and 0.5, 1.0 (immediately before terminating the infusion), 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Days 1 and 8. AUC is defined as the area under the paclitaxel concentration-time curve as a measure of drug exposure. AUC(0-24) is area under the plasma concentration-time curve from the start of infusion (time 0) to 24 hours after the start of the infusion.|Days 1 and 8|PK Parameter Population||hr*ng/mL||95% Confidence Interval|Geometric Mean
742761|NCT00486954|Secondary|Tmax of Paclitaxel in the Pilot Part of the Study|PK samples were collected just before the start of infusion and 0.5, 1.0 (immediately before terminating the infusion), 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Days 1 and 8.|Days 1 and 8|PK Parameter Population||hr||Full Range|Median
742762|NCT00486954|Secondary|Cmax of Paclitaxel in the Pilot Part of the Study|PK samples were collected just before the start of infusion and 0.5, 1.0 (immediately before terminating the infusion), 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Days 1 and 8.|Days 1 and 8|PK Parameter Population||ng/mL||95% Confidence Interval|Geometric Mean
742763|NCT00486954|Secondary|Area Under the Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24]) of Lapatinib in the Pilot Part of the Study|PK samples were collected at pre-dose and at 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Days 8 and 14. AUC is defined as the area under the lapatinib concentration-time curve as a measure of drug exposure. AUC(0-24) is area under the plasma concentration-time curve from time 0 to 24 hours after oral adminisation.|Days 8 and 14|PK Parameter Population||hr*ng/mL||95% Confidence Interval|Geometric Mean
743952|NCT00504556|Secondary|Pharmacokinetics (Cmin, Cmax) of DU-176b in Subjects Receiving DU-176b|Median (min, max) values of Cmin,ss; Cmax,ss|3 months|||ng/mL||Full Range|Median
742766|NCT00486954|Primary|Overall Survival (OS) in the Randomized Part of the Study|OS was defined as the time from randomization until death due to any cause. For participants who did not die, time to death was censored at the time of last contact. For censored participants, time to death was defined as the time from randomization to the time of last contact.|From randomization until death due to any cause (up to 42.58 months)|Intent-to-Treat Population: all participants who were randomized to study treatment, regardless of whether they actually received study medication||months||95% Confidence Interval|Median
742767|NCT00486954|Primary|Number of Participants With Dose Limiting Toxicities (DLTs) in the Pilot Part of the Study|DLTs consisted of only drug-related toxicities (neurologic and non-neurologic DLTs). A neurologic DLT was defined as grade 3/4 clinically significant peripheral motor and/or sensitive neuropathy. Non-neurologic DLTs mainly included the following: grade 3/4 clinically significant non-hematological toxicity (except nausea), grade 4 neutropenia lasting >=7 days, thrombocytopenia (<=25000 cells per cubic millimeter), inability to begin next treatment within 2 weeks of scheduled dosing due to unresolved toxicity, treatment delay (due to toxicity) of >5 days, for Days 8 or 15 of weekly paclitaxel.|28 days|Safety Population (Pilot part): all participants who received at least one dose of investigational product in the Pilot part of the study||Participants|||Number
742768|NCT00487084|Secondary|Supplemental Analgesia in First 48 Hours|Participants requesting supplemental analgesia in first 48 hours|48 hours|||Participants|||Number
742769|NCT00487084|Primary|Supplemental Analgesia in First 90 Minutes|Participants requesting supplemental analgesia in the first 90 minutes following study drug|90 min|||participants|||Number
742770|NCT00487084|Secondary|Verbal Rating Score (0 to 10) for Pain (VRPS)|Verbal Rating Pain Score (VRPS) at time of post-anesthesia recovery room entry, where 0 = no pain and 10 = worst pain imaginable|At recovery room entry|Verbal Rating Score for Pain (0-10) where 0 = no pain and 10 = worst pain imaginable||Scores on a scale||Inter-Quartile Range|Median
742771|NCT00487084|Primary|Duration of Continuing Analgesia|Time to first request for supplemental analgesia|48 hours|All participants receiving the intervention were analyzed||hours||95% Confidence Interval|Median
742772|NCT00487162|Secondary|Hemodynamic Instability||0-48 hours post op|no analysis was done as the study was terminated due to patient safety concerns|||||
742773|NCT00487162|Primary|Wound Infection||7-10 days post op|no analysis was done as the study was terminated due to patient safety concerns|||||
742774|NCT00487188|Secondary|Number of Participants With Adverse Events (AEs) During the Induction Phase|A serious AE (SAE) is an event which: results in death, is life-threatening, disabling or incapacitating; is a congenital anomaly in the offspring of a patient who received study drug; requires or prolongs inpatient hospitalization; jeopardizes the patient or require medical or surgical intervention to prevent one of the outcomes above; any Grade 4 laboratory value considered by the investigator clinically significant or that requires an action; any injection site reaction that meets SAE criteria above. Non-serious AEs reported include pneumonia and non-serious AEs that led to discontinuation.|Start of the study treatment until the end of the Induction Phase (Week 12 to Week 32)|Safety Population||participants|||Number
742775|NCT00487188|Secondary|Percentage of Participants With Improvement in CD4+ Count During the Maintenance Phase|Improvement of CD4+ count defined as having from 100 to less than 200 CD4+ cells/mm^3 at Baseline 2 (BL2) and greater than or equal to 200 cells/mm^3 at Week 48.|Baseline 2 to Week 48.|Maintenance Phase ITT2 population with a Baseline 2 CD4+ count of ≥100 to <200 cells/mm^3.||percentage of participants|||Number
742776|NCT00487188|Secondary|Percentage of Participants Maintaining CD4+ Count During the Maintenance Phase|Maintenance of CD4+ count defined as having greater than or equal to 200 cells/mm^3 at Baseline 2 (BL2) and greater than or equal to 200 cells/mm^3 at Week 48.|Baseline 2 to Week 48.|Maintenance Phase ITT2 population with a Baseline 2 CD4+ count of greater than or equal to 200 cells/mm^3.||percentage of participants|||Number
742777|NCT00487188|Secondary|Number of Participants With Virological Failure During the Maintenance Phase|Virological failure was defined by 2 consecutive HIV-1 RNA values ≥ 400 copies/mL during the Maintenance Phase.|From Baseline 2 to Week 48.|Maintenance Phase Intent-to-Treat Population 2 (ITT2)||Participants|||Number
742778|NCT00487188|Secondary|Time to Virological Failure During the Maintenance Phase|"Time to virological failure (defined as HIV-1 RNA ≥ 400 copies/mL) was counted from Baseline 2 until the first of the two consecutive ≥400 copies/mL measurements.
Only patients who were qualified for entering the Maintenance Phase were included in the analyses."|From Baseline 2 to Week 48.|Maintenance Phase Intent-to-Treat Population 2 (ITT2)||days||Inter-Quartile Range|Median
742779|NCT00487188|Secondary|Time to Loss of Viral Response During the Maintenance Phase|"The time to loss of viral response (defined as HIV-1 RNA <50 copies/mL) was counted from Baseline 2 until the first of two consecutive ≥50 copies/mL measurements.
Only patients who were qualified for entering the Maintenance Phase were included in the analysis."|From Baseline 2 to Week 48.|Maintenance Phase Intent-to-Treat Population 2 (ITT2)||days||Inter-Quartile Range|Median
742780|NCT00487188|Secondary|Change From Baseline to Week 48 in Cluster Differentiation Antigen Four Positive (CD4) Cell Counts|Change from Baseline in CD4 Cell Counts at Week 48. Least squares means were calculated from an ANCOVA model with treatment and baseline CD4 count as independent variables.|Baseline 1 and Week 48|Intent-to-Treat Population 2 (ITT2) population (patients evaluable for efficacy in the Maintenance Phase). Baseline values were carried forward (i.e. the change from baseline set to zero) for patients with missing data at week 48 or who withdrew prior to the week 48 time window.||cells/mm^3||95% Confidence Interval|Least Squares Mean
742781|NCT00487188|Secondary|Percentage of Maintenance Phase Participants With Viral Load < 50 Copies/mL at 48 Weeks|The percentage of participants from the Maintenance Phase who maintained HIV-1 RNA < 50 copies/mL at Week 48. Patients who discontinued from the study, rebounded to ≥ 50 copies/mL (i.e., had two consecutive readings ≥ 50 copies/mL), had missing data or had virological failure by Week 48 were classed as non-responders.|Week 48|Maintenance Phase Intent-to-Treat Population 2 (ITT2).||percentage of participants|||Number
742782|NCT00487188|Secondary|Percentage of Induction Phase Participants With Viral Load < 50 Copies/mL at 48 Weeks|The percentage of participants from the Induction Phase who maintained HIV-1 RNA < 50 Copies/mL at Week 48. Patients who discontinued from the study, rebounded to ≥ 50 copies/mL (i.e., had two consecutive readings ≥ 50 copies/mL), had missing data or had virological failure by Week 48 were classed as non-responders.|Week 48|Induction Phase Intent-to-Treat Population 1 (ITT1).||percentage of participants|||Number
748850|NCT00538642|Primary|Insulin Sensitivity|Euglycemic clamp method|Baseline|||mg glucose/kg.min/μIU insulin||Standard Deviation|Mean
742783|NCT00487188|Secondary|Change From Baseline to Week 24 in Cluster Differentiation Antigen Four Positive (CD4+) Cell Counts|Change from Baseline in CD4+ Cell Counts at Week 24. Least squares means were calculated from an ANCOVA model with treatment as an independent variable.|Baseline and Week 24|Intent-to-Treat Population 1 (ITT1) population (patients evaluable for efficacy in the Induction Phase). Baseline values were carried forward (i.e. the change from baseline set to zero) for patients with missing data at week 24 or who withdrew prior to the week 24 time window.||cells/mm^3||95% Confidence Interval|Least Squares Mean
742784|NCT00487188|Secondary|Change From Baseline to Week 24 in Viral Load|"Change from Baseline in log10 HIV-1 RNA at Week 24. Least squares means were calculated from an analysis of covariance (ANCOVA) model with treatment, a flag variable removed ENF at re-randomization and Baseline viral load as independent variables."|Baseline and Week 24|Intent-to-Treat Population 1 (ITT1) population (patients evaluable for efficacy in the Induction Phase). Baseline values were carried forward (i.e. the change from baseline set to zero) for patients with missing data at week 24 or who withdrew prior to the week 24 time window.||log10 copies/mL||95% Confidence Interval|Least Squares Mean
742785|NCT00487188|Secondary|Number of Participants With Viral Suppression HIV-1 RNA < 400 Copies/mL During the Induction Phase|Participants whose viral load achieved suppression (HIV-1 RNA < 400 copies/mL) by Week 24 at the latest, confirmed at Week 28 (2 consecutive assessments ≥ 28 days apart) were defined as responders. Patients who discontinued the study or did not respond to assigned treatment by Week 28 were considered as non-responders.|From Baseline 1 to Week 28|ITT1 population (patients evaluable for efficacy in the induction phase)||Participants|||Number
742786|NCT00487188|Secondary|Time to Achieving HIV-1 RNA < 50 Copies/mL During the Induction Phase|"The time to achieving HIV-1 RNA <50 copies/mL was counted from Baseline 1 until the first of the two consecutive <50 copies/mL measurements.
Patients who discontinued from the study or patients who did not have confirmed virological response by week 28 were classed as non-responders and censored at Week 24."|Baseline 1 until Week 28.|Intent-to-Treat Population 1 (ITT1) population (patients evaluable for efficacy in the induction phase).||days||Inter-Quartile Range|Median
742787|NCT00487188|Primary|Number of Participants With Viral Suppression: HIV-1 RNA < 50 Copies/mL During the Induction Phase|Participants whose viral load achieved suppression (HIV-1 RNA < 50 copies/mL) at Week 24 at the latest, confirmed at Week 28 (2 consecutive assessments ≥ 28 days apart) were defined as responders. Patients who discontinued the study or did not respond to assigned treatment by week 28 were considered as non-responders.|From Baseline 1 to Week 28|Intent-to-Treat Population 1 (ITT1) population (patients evaluable for efficacy in the induction phase)||Participants|||Number
742788|NCT00487240|Secondary|Insulin Dose (Total and By Component [Basal and Bolus])|Total daily insulin dose (U/day) was assessed.|32 weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.||units of insulin per day (U/day)||Standard Deviation|Mean
742789|NCT00487240|Secondary|Insulin Dose Per Body Weight (Total and By Component [Basal and Bolus])|Total daily insulin dose adjusted for body weight (U/kg/day) was assessed.|32 Weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.||units of insulin per kilogram per day||Standard Deviation|Mean
742790|NCT00487240|Secondary|Change From Baseline in Absolute Body Weight at 32 Week Endpoint||Baseline, 32 Weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population.||kilograms||Standard Deviation|Mean
742791|NCT00487240|Secondary|30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint||baseline to 32 weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.||hypoglycemic events per 30 days||Standard Deviation|Mean
742792|NCT00487240|Secondary|1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint|Nocturnal: Defined as any hypoglycemic event that occurs between bedtime and waking. Non-Nocturnal: Defined as any hypoglycemic event that occurs between waking and bedtime. Severe: An episode with symptoms consistent with neuroglycopenia in which the patient requires the assistance of another person; associated with either a blood glucose level of <2.8 mmol/L (<50 mg/dL) or prompt recovery after oral carbohydrate, glucagon, or intravenous glucose.|baseline to 32 weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.||hypoglycemic events per 1 year||Standard Deviation|Mean
742793|NCT00487240|Secondary|Number of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe Hypoglycemia) Overall and at Endpoint|Nocturnal: Defined as any hypoglycemic event that occurs between bedtime and waking. Non-Nocturnal: Defined as any hypoglycemic event that occurs between waking and bedtime. Severe: An episode with symptoms consistent with neuroglycopenia in which the patient requires the assistance of another person; associated with either a blood glucose level of <2.8 mmol/L (<50 mg/dL) or prompt recovery after oral carbohydrate, glucagon, or intravenous glucose.|Baseline to 32 Weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.||episodes of hypoglycemia|||Number
742794|NCT00487240|Secondary|Glycemic Variability at Endpoint|Glycemic variability was measured by standard deviation (SD) value of fasting blood glucose as measured by intra-patient glycemic variability (determined by the 7-point self-monitored blood glucose [SMBG] profiles at endpoint); mean value (M-value), which was the mean of the intra-days self-monitored blood glucose values, and by the mean of daily difference (MODD), which was the mean of the between-days self-monitored blood glucose values.|32 Weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.||millimoles per Liter (mmol/L)||Standard Deviation|Mean
742795|NCT00487240|Secondary|7-Point Self-Monitored Blood Glucose (SMBG) at Endpoint|Actual daily mean blood glucose levels at endpoint. The SMBG excursion is the difference between the postprandial and preprandial blood glucose concentration taken at the morning, midday and evening meals.|32 Weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.||millimoles per Liter (mmol/L)||Standard Deviation|Mean
743953|NCT00504556|Secondary|Effects on Biomarker Prothrombin Fragments|Mean (SD) change from baseline in Prothrombin Fragments 1 and 2 (F1 and F2)|3 months|||pmol/L||Standard Deviation|Mean
776654|NCT00768066|Secondary|Number of Deaths||12-months post-catheterization|||participants|||Number
742797|NCT00487240|Secondary|Actual and Change From Baseline Hemoglobin A1c (HbA1c) Values|"The summary statistics represents the mean of all subjects. Change from baseline is calculated for each individual subject for the specific visit and then the mean change from baseline is calculated by averaging out for all subjects. [Sum over all (i) {A1c at Week 8 for Subject(i) minus A1c Baseline for Subject (i)}/Total Subjects]. Therefore, for example, the Change from Baseline is not equal to the difference of Mean A1c for Week 8 minus Mean A1c for baseline."|Baseline, 8,16, 24, 32 Weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population.||percent of HbA1c||Standard Error|Least Squares Mean
742798|NCT00487240|Primary|Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint||baseline and 32 weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.||percent of HbA1c||Standard Error|Least Squares Mean
742799|NCT00487279|Secondary|Arrhythmic Mortality|Arrhythmic mortality was reported as the number of randomized patients who died due to arrhythmic death. Arrhythmic death was defined as death due to arrhythmia or sudden death.|Total survival will be evaluated 2 years after the last patient is randomized.|||participants|||Number
742800|NCT00487279|Primary|All-cause Mortality||Total survival will be evaluated 2 years after the last patient is randomized.|Intent to Treat||participants|||Number
742801|NCT00487396|Secondary|The Additional Diagnostic Value and Sensitivity of CE Compared With Ileo-colonoscopy and SBFT Will be Evaluated by the Number of Positive Findings, Detected by Each Modality, Which Were Considered by the Investigator to be Crohn's Disease Related.||four months from enrollment||||||
742802|NCT00487396|Secondary|Small Bowel Disease Present (Will be Categorized as Mild, Moderate or Severe)or Suspicious for Small Bowel Disease or No Small Bowel Disease Present.||four months from enrollment||||||
742803|NCT00487396|Primary|The Number of Positive Findings, Detected by Each Modality, Which Were Considered by the Investigator to be Crohn's Disease Related|The number of positive findings related to Crohn that were detected by capsule endoscopy procedure and ileo-colonoscopy as compared to the number of findings related to Crohn that were detected by ileo-colonoscopy and small bowel follow through(SBFT) procedures.|four months from enrollment|Findings were catagorized (ulcers, inflammatory lesions, stricturing lesions and others) and for each category, the numbers of found and missed pathologies, i.e. the detection capabilities, were calculated for the combination of the procedures (i.e. CE and IC vs. SBFT and IC) and were limited to one count per location (SB, terminal ileum, colon).||Number of findings|||Number
742804|NCT00487435|Secondary|Change From Baseline in Average Pain Intensity Scores at Week 52 Using the Numerical Rating Scale (NRS)|"The subjects indicated the average level of pain experienced, at each study visit, over the previous 24 hours on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Baseline, 52 weeks|observed cases||Scores on a Scale||Standard Deviation|Mean
742805|NCT00487435|Primary|Number of Subjects With Treatment-emergent Adverse Events (TEAE)|The number of subjects who reported a TEAE during the treatment period. TEAE was defined as any adverse event that started or worsened on or after the start of the study medication and up to 3 days after the discontinuation of the study medication.|52 weeks|Safety analysis set (All randomized subjects who took at least one dose of study medication).||participants|||Number
742806|NCT00487461|Secondary|To Determine Efficiency of Simvastatin in Decreasing the Incidence of Clinical Vasospasm in aSAH, and Define the Optimal Dose of Simvastatin and to Measure Outcome at 6 Months Follow up|Study PI left before the efficacy of Simvastatin decreasing the incidence of clinical vasospasm in aSAH, and defining the optimal dose of Simvastatin and measuring the outcome at 6 months follow up data was collected for the study and therefore these outcomes will never be analyzed.|6 months|Study PI left before the efficacy of Simvastatin decreasing the incidence of clinical vasospasm in aSAH, and defining the optimal dose of Simvastatin and measuring the outcome at 6 months follow up data was collected for the study and therefore these outcomes will never be analyzed.|||||
742807|NCT00487461|Primary|To Measure Outcome in Patients Diagnosed With Aneurysmal Subarachnoid Hemorrhage (aSAH) Treated With Simvastatin, by Assessing Neurological Outcome by Accessing Glasgow Outcome Score, Modified Rankin Scale, and Barthel Index Score at Day 21 Post aSAH||21 days|Study PI left before outcome data was collected for the study and therefore the Outcome(s) will never be analyzed.|||||
743048|NCT00488514|Primary|Number of Participants With the Indicated Drug-related Adverse Events|The number of participants with a drug-related adverse event (AE). Frequency threshold for reporting a drug-related AE: >=2% participants recorded as having at least one occurrence of a reported drug-related AE.|Baseline through End of Study (up to Month 12)|Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet||participants|||Number
742812|NCT00487552|Post-Hoc|Success Rate of Mature Anastomosis Creation Using Magnetic Anastomosis Device (MAD)|Endoscopy was performed to determine whether an anastomosis (hole) was successfully created.|Approximately 8-10 days|Patients who underwent a second endoscopy after successful magnet placement||participants|||Number
742813|NCT00487552|Primary|Success Rate Associated With the Creation of a Gastro-jejunal Anastomosis Using the Cook Magnetic Anastomosis Device With Trans-anastomotic Deployment of a Gastro-jejunal or Duodenal Stent|Success is defined as placement of the gastric and jejunal magnets, creation of the anastomosis, and deployment of the gastro-jejunal stent.|Approximately 8-10 days|||participants|||Number
742814|NCT00487565|Primary|Knee Active Flexion|Active flexion is measured by how much a patient can bend their knee on their own, without assistance.|12 month|||degrees||Standard Deviation|Mean
742815|NCT00487578|Secondary|Sustained Treatment Effect|Sustained treatment effect as measured by the MEWT Performance Index score compared to change in number of Headache Days. Results would be presented in the form of a correlation analysis. There is an expected negative correlation as performance index increases and number of headache days decrease (a correlation of -1).|Day 0, Day 10, Day 30|No analysis was conducted. Study terminated due to expiration of study medication and low enrollment.|||||
742816|NCT00487578|Secondary|Quality of Life Scores|"Quality of life as measured by Migraine Specific Quality of Life questionnaire (MSQ) scores. 14 questions ask how often headaches have interfered with specific daily activities in previous 4 weeks. 6-point scale ranges from None of the time to All of the time."|Day 0, Day 30, Day 90|No analysis was conducted. Study terminated due to expiration of study medication and low enrollment.|||||
742817|NCT00487578|Secondary|Overall Satisfaction With Medication Score|Subject overall satisfaction with effectiveness of the therapy as measured by score on the Satisfaction with Medication questionnaire. Scale range: Very satisfied, Satisfied, Neutral, Dissatisfied, Very dissatisfied.|Day 30, Day 90|No analysis was conducted. Study terminated due to expiration of study medication and low enrollment.|||||
742818|NCT00487578|Primary|Mental Efficiency Workload Test (MEWT) Performance Index Score|Cognitive function as measured by Performance Index scores on the Mental Efficiency Workload Test (MEWT). On the performance index scale of 1 to 10, 1 indicates the poorest level and 10 indicates the best level of cognitive functioning. Tests include: Simple reaction time, Running memory, Matching to sample, Math processing and a sleep scale.|Day 0, Day 10, Day 30|No analysis was conducted. Study terminated due to expiration of study medication and low enrollment.|||||
742819|NCT00487578|Primary|Headache Impact Test-6 (HIT-6) Score|Impact of headache symptoms on subject's life as measured by HIT-6 questionnaire scores. Possible scores range from 36 to 78. Score of 48 or less indicates headache has little impact on life. Score of 60-78 indicative of very severe impact.|Day 0, Day 30|No analysis was conducted. Study terminated due to expiration of study medication and low enrollment.|||||
742820|NCT00487578|Primary|Headache Days|Number of headache days as measured by the Headache Diary|Day 30|No analysis was conducted. Study terminated due to expiration of study medication and low enrollment.|||||
742821|NCT00487669|Secondary|Overall Survival||time from study entry until death|||months||95% Confidence Interval|Median
742822|NCT00487669|Secondary|Time to Progression||time from study entry until the first documented sign of progression|||months||95% Confidence Interval|Median
742823|NCT00487669|Primary|To Evaluate the Overall Response Rate (Complete Plus Partial Responses by RECIST Criteria) to the Combination of Paclitaxel Poliglumex and Pemetrexed as Therapy in Patients With Advanced NSCLC.||CT or MRI scans of the chest will be obtained after every 2 cycles (6-week intervals +/- 7 days)|||participants|||Number
742824|NCT00487695|Secondary|Mean Number of Biopsies Taken in Barrett's Surveillance Patients|The number of biopsies taken during each procedure (i.e. the number of biopsies taken during CLE, or the number of biopsies taken during standard EGD). Biopsies are taken during CLE only if CLE shows that the esophageal mucosa is abnormal. Esophageal biopsies are taken during standard EGD using a standard Barrett's esophagus protocol (4 quadrants, every 1-2 cm of the Barrett's esophagus). This analysis looks at the patients with Barrett's esophagus in the study who were undergoing surveillance EGD (no suspected neoplasia).|6 weeks|Analysis was per protocol. Each participant was compared to self, so if the participant did not complete, the study, no comparison could be made. The patients in this analysis were referred for surveillance of Barrett's esophagus (no suspected neoplasia).||mean number of biopsies||Full Range|Mean
742825|NCT00487695|Secondary|Mean Number of Biopsies With Neoplasia in Barrett's Surveillance Patients|The number of biopsies from each procedure (i.e. biopsies taken during CLE, or biopsies taken during standard EGD) that showed neoplasia. Neoplasia is high grade dysplasia or cancer. This analysis looks at patients undergoing surveillance EGD for Barrett's esophagus (no suspected neoplasia).|6 weeks|Analysis was per protocol. Each participant was compared to self, so if the participant did not complete the study, no comparison could be made.||number of biopsies with neoplasia||Full Range|Mean
742826|NCT00487695|Secondary|Diagnostic Yield for Neoplasia in Barrett's Surveillance Patients|Our hypothesis was that the yield for neoplasia would be higher using confocal laser endomicroscopy compared to standard endoscopy. The null hypothesis would be that there is no difference in yield for neoplasia when CLE is used compared to standard endoscopy. This analysis looks specifically at patients who were referred for surveillance of Barrett's esophagus (no suspected neoplasia).|6 weeks|Analysis was per protocol as the patients who did not undergo CLE could not be analyzed at all (cannot compare 2 procedures when only one (or zero) are performed).||percent yield for neoplasia|||Number
743049|NCT00488592|Secondary|Clinical Response|Hematological response status|16 weeks||||||
743345|NCT00496782|Secondary|Change in Detectable Tropism From Baseline|Number of subjects who switch their tropism status from Baseline to Days 7, 14, and Week 24/End of Study(EOS)/Discontinuation|Baseline, Day 15 and Week 24/End of Study/Discontinuation|Study was canceled with only 16 subjects of 60 subjects required to enroll.||Participants|||Number
742827|NCT00487695|Secondary|Mean Number of Biopsies Taken in High Risk Patients (Suspected Neoplasia)|The number of biopsies taken during each procedure (i.e. the number of biopsies taken during CLE, or the number of biopsies taken during standard EGD). Biopsies are taken during CLE only if CLE shows that the esophageal mucosa is abnormal. Esophageal biopsies are taken during standard EGD using a standard Barrett's esophagus protocol (4 quadrants, every 1-2 cm of the Barrett's esophagus). This analysis looks at the Barrett's patients with suspected (but not known) neoplasia.|6 weeks|per protocol as participants would only have data to compare if they completed both endoscopies||mean number of biopsies||Full Range|Mean
742828|NCT00487695|Secondary|Mean Number of Biopsies With Neoplasia in High Risk Patients (Suspected Neoplasia)|The number of biopsies from each procedure (i.e. biopsies taken during CLE, or biopsies taken during standard EGD) that showed neoplasia. Neoplasia is high grade dysplasia or cancer. This analysis looks at patients with Barrett's suspected (but not known) neoplasia.|6 weeks|Analysis was per protocol. Each participant was compared to self, so if the participant did not complete the study, no comparison could be made.||mean number of biopsies with neoplasia||Full Range|Mean
742829|NCT00487695|Primary|Diagnostic Yield for Neoplasia in High Risk Patients(Suspected Neoplasia)|The yield for neoplasia is calculated by the number of biopsies showing neoplasia over the total number of biopsies taken (normal + neoplastic biopsies)|6 weeks|Analysis was per protocol as the patients who did not undergo CLE could not be analyzed at all (cannot compare 2 procedures when only one (or zero) are performed. This analysis looks specifically at patients with Barrett's and suspected (but not known) neoplasia.||percent yield for neoplasia|||Number
742830|NCT00487721|Primary|Measurable Silibinin Tissue Levels|To determine if measurable silibinin tissue levels are detectable in the prostate glands of men treated with Silybin-Phytosome administered according to the protocol. Analysis of silibinin in human fluid and tissue samples was carried out by Liquid chromatography - mass spectrometric (LC/MS/MS) following liquid extraction. Briefly, sample was extracted in acidified ethyl acetate by vortex. Following centrifugation, the organic layer was evaporated to dryness in a rotary evaporator and the samples were dissolved in acetonitrile/ammonium acetate with acetic acid for analysis. Sample analysis was done using an Applied Biosystems 3200 Q-Trap 1 triple quadrupole mass spectrometer with an Agilent 1100 Liquid Chromatography system and HTC-PAL Leap Autosampler. Quantitation of silibinin in samples was done by internal standard reference and batch analysis verified by the inclusion of spiked quality control samples in the appropriate matrix.|At the time of surgery|Per protocol analysis was used and 6 participants that were enrolled in the study were included in the analysis.||Participants|||Number
742831|NCT00487747|Secondary|Mean Change in Laboratory Parameters (ALT Levels)|Mean Change in Laboratory parameters (ALT levels) is reported.|From Screening (Day 0) to Week 96|Safety population included all participants who received at least one dose of the study drug.||International units per liter (IU/L)||Standard Deviation|Mean
742832|NCT00487747|Secondary|Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs)|All participants who received at least one dose of the study drug were analysed. Number of participants with any adverse events and any serious adverse events are reported.|Up to Week 96|Safety population included all participants who received at least one dose of the study drug.||Participants|||Number
742833|NCT00487747|Secondary|Number of HBeAg Negative Participants With HBV DNA <400 Copies/mL, HbsAg Seroconversion and Normalization of ALT|Hepatitis B Surface Antigen (HBsAg) seroconversion is defined as a decrease in HBsAg to undetectable levels and a gain of detectable levels of HBsAb. This study included 14 HBeAg negative participants.|Week 96|All participants who received at least one dose of the study drug were considered for analysis.||Participants|||Number
742834|NCT00487747|Secondary|Number of HBeAg Positive Participants With HBV DNA <400 Copies Per mL, HBsAg Seroconversion, Normalization of ALT, and Sustained HBe Seroconversion|Hepatitis B Surface Antigen (HBsAg) seroconversion is defined as a decrease in HBsAg to undetectable levels and a gain of detectable levels of Hepatitis B surface antibody (HBsAb). Sustained HBe seroconversion is defined as loss of HBeAg and presence of hepatitis B e-antibody (HBeAb). This study included 4 HBeAg positive participants.|Week 96|All participants who received at least one dose of the study drug were considered for analysis.||Participants|||Number
742835|NCT00487747|Primary|Number of HBeAg Negative Participants With HBV DNA < 20,000 Copies Per mL|This study included 14 HBeAg negative participants. Participants with HBV DNA <20,000 copies/mL were reported.|Week 96|All participants who received at least one dose of the study drug were considered for analysis.||Participants|||Number
742836|NCT00487747|Primary|Number of HBeAg Positive Participants With Hepatitis B Virus Deoxyribonucleic Acid <100,000 Copies Per mL|This study included four Hepatitis B Early Antigen (HBeAg) positive participants. Participants with Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <100,000 copies/mL were reported.|Week 96|All participants who received at least one dose of the study drug were considered for analysis.||Participants|||Number
742837|NCT00487825|Secondary|The Number of Participants in Clinical Remission Based on Disease Activity Score (DAS)28 and Simplified Disease Activity Index (SDAI)|"At each visit (including baseline) the DAS28 and SDAI variables were derived using the following formulas:
DAS28 = 0.56*√ (tender28) + 0.28 * √ (swollen28) + 0.36 * loge(CRP+1) + 0.014*PGDA+ 0.96; SDAI = tender28 + swollen28 + CRP + (PGDA / 10) + (EGDA / 10) where tender28 is the tender 28-joint count, swollen28 is the swollen 28-joint count, CRP is C-reactive protein, PGDA is the patient’s global assessment of disease activity and EGDA is the physician’s global assessment of disease activity.
The Number of Participants in clinical remission is defined as the DAS28 ≤ 2.6 or SDAI ≤ 3.3."|At 6 weeks, 14 weeks and 24 weeks|Intention to treat (ITT) population||Participants|||Number
742838|NCT00487825|Secondary|Percentage of Participants Achieving a Good European League Against Rheumatism (EULAR) Response (Based on the Disease Activity Score (DAS28)) at 26 Weeks|At each visit (including baseline) the DAS28 is derived as: DAS28 = 0.56*√ (tender28) + 0.28 * √ (swollen28) + 0.36 * loge(CRP+1) + 0.014*PGDA+ 0.96; where tender28 is the tender 28-joint count, swollen28 is the swollen 28-joint count, PGDA is the patient’s global assessment of disease activity. Patients can be scored on a range of 0 to 10. When current DAS < 3.2, good response is defined as >1.2 improvement in DAS from baseline and non-response is improvement of ≤0.6. When current DAS >5.1, non-response is improvement of >0.6 but ≤1.2 . All others are moderate responses.|At 26 weeks|Intention to treat (ITT) population||Percentage of Participants|||Number
743091|NCT00489216|Secondary|Overall Hepatic Response Rate|The normalization of the total serum bilirubin to <2mg/dL|On study days 29 and 57 after 4 and 8 doses of weekly subcutaneous efalizumab|There is no data for this outcome measure as no enrolled patients had an elevated bilirubin level.|||||
742839|NCT00487825|Secondary|Response to Intravenous (IV) Canakinumab and Oral Methotrexate (MTX) Therapy (ACR20, 70, 90) Compared to MTX Alone|"A patient was considered as improved according to the criteria of ACR 20 equaling at least 20%, ACR70 = 70%, and ACR90 = 90% improvement in the tender and the swollen 28-joint count, and in at least 3 of the following 5 measures:
Patient’s pain assessment (Visual Analogue Scale (VAS) 100 mm)
Patient’s global assessment of disease activity (VAS 100 mm)
Physician’s global assessment of disease activity (VAS 100 mm)
Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)
Acute phase reactant (high sensitivity C-reactive Protein (hsCRP))"|At 6 weeks, 14 weeks, and 26 weeks|Intent-to-treat population (ITT)||Participants|||Number
742840|NCT00487825|Primary|Response to Intravenous Canakinumab and Oral Methotrexate (MTX) Compared to MTX Alone as Determined by 50% Improvement in Symptoms According to the American College of Rheumatology Criteria (ACR50)|"A patient was considered as improved according to the ACR50 criteria if she/he had at least a 50 % improvement in both the tender and the swollen 28-joint count, and in at least 3 of the following 5 measures:
Patient’s pain assessment (Visual Analogue Scale (VAS) 100 mm)
Patient’s global assessment of disease activity (VAS 100 mm)
Physician’s global assessment of disease activity (VAS 100 mm)
Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)
Acute phase reactant (high sensitivity C-reactive Protein (hsCRP))"|6, 14, and 26 weeks of treatment|Intent-to-treat population (ITT)||Participants|||Number
742841|NCT00487942|Secondary|Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Baseline|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The CGI-S was assessed at Baseline, Week 1, Week 2 and Week 4. Data is presented representing the number of subjects who rated each CGI-S score at Baseline.|Baseline|Full analysis set defined as the number of subjects who had at least one observation after baseline||Participants|||Number
742842|NCT00487942|Secondary|Patient Global Impression of Change (PGIC) at Week 4|The PGIC is a patient-rated scale of the change in disease severity. The PGIC uses the following 7 categories and scoring assignments: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. The number of subjects who rated each category at Week 4 is presented here.|Week 4|Full analysis set defined as subjects who received one or more doses of the study drug and who completed an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.||Participants|||Number
742843|NCT00487942|Secondary|Patient Global Impression of Change (PGIC) at Week 2|The PGIC is a patient-rated scale of the change in disease severity. The PGIC uses the following 7 categories and scoring assignments: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. The number of subjects who rated each category at Week 2 is presented here.|Week 2|Full analysis set defined as subjects who received one or more doses of the study drug and who completed an efficacy assessment at week 2. Summary statistics are provided for the observed data only, missing data was not estimated.||Participants|||Number
742844|NCT00487942|Secondary|Patient Global Impression of Change (PGIC) at Week 1|The PGIC is a patient-rated scale of the change in disease severity. The PGIC uses the following 7 categories and scoring assignments: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. The number of subjects who rated each category at Week 1 is presented here.|Week 1|Full analysis set defined as subjects who received one or more doses of the study drug and who completed an efficacy assessment at week 1. Summary statistics are provided for the observed data only, missing data was not estimated.||Participants|||Number
742845|NCT00487942|Secondary|Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Week 4|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The CGI-S was assessed at Baseline, Week 1, Week 2 and Week 4. Data is presented representing the number of subjects who rated each CGI-S score at week 4.|Baseline and 4 weeks|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.||Participants|||Number
742846|NCT00487942|Secondary|Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Week 2|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The CGI-S was assessed at Baseline, Week 1, Week 2 and Week 4. Data is presented representing the number of subjects who rated each CGI-S score at week 2.|Baseline and 2 weeks|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 2. Summary statistics are provided for the observed data only, missing data was not estimated.||Participants|||Number
742847|NCT00487942|Secondary|Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Week 1|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The CGI-S was assessed at Baseline, Week 1, Week 2 and Week 4. Data is presented representing the number of subjects who rated each CGI-S score at week 1.|Baseline and 1 week|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 1. Summary statistics are provided for the observed data only, missing data was not estimated.||Participants|||Number
742899|NCT00487942|Secondary|Change From Baseline to Week 2 in the Median Value for Actigraphy Data of Total Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 2 in total activity.|Baseline and Week 2|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 2||Counts||Standard Deviation|Mean
743954|NCT00504556|Secondary|Effects on Biomarker D-dimer|Mean (SD) change from baseline in D-dimer|3 months|||ng/mL||Standard Deviation|Mean
742848|NCT00487942|Secondary|Change From Baseline to Week 4 in Epworth Sleepiness Scale (ESS) Total Scores|ESS is a self-administered subjective measure of daytime sleepiness, based on responses to questions referring to 8 everyday situations (eg. sitting and reading, talking to someone) and reflects a patient's propensity to fall asleep in those situations. Score for the ESS range from 0 to 24 with higher scores indicating greater daytime sleepiness. Data here represents the change from Baseline to Week 4 in the ESS total score.|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and who completed an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
742849|NCT00487942|Secondary|Change From Baseline to Week 2 in Epworth Sleepiness Scale (ESS) Total Scores|ESS is a self-administered subjective measure of daytime sleepiness, based on responses to questions referring to 8 everyday situations (eg. sitting and reading, talking to someone) and reflects a patient's propensity to fall asleep in those situations. Score for the ESS range from 0 to 24 with higher scores indicating greater daytime sleepiness. Data here represents the change from Baseline to Week 2 in the ESS total score.|Baseline and 2 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and who completed an efficacy assessment at week 2. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
742850|NCT00487942|Secondary|Change From Baseline to Week 1 in Epworth Sleepiness Scale (ESS) Total Scores|ESS is a self-administered subjective measure of daytime sleepiness, based on responses to questions referring to 8 everyday situations (eg. sitting and reading, talking to someone) and reflects a patient's propensity to fall asleep in those situations. Score for the ESS range from 0 to 24 with higher scores indicating greater daytime sleepiness. Data here represents the change from Baseline to Week 1 in the ESS total score.|Baseline and 1 week following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and who completed an efficacy assessment at week 1. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
742851|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation Following Baseline in Epworth Sleepiness Scale (ESS) Total Scores|ESS is a self-administered subjective measure of daytime sleepiness, based on responses to questions referring to 8 everyday situations (eg. sitting and reading, talking to someone) and reflects a patient's propensity to fall asleep in those situations. Score for the ESS range from 0 to 24 with higher scores indicating greater daytime sleepiness. Data here represents the change from Baseline to Endpoint (Week 4 or last observation following baseline) in the ESS total score.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as the number of subjects who had at least one baseline observation and one observation after baseline||Units on a scale||Standard Deviation|Mean
742852|NCT00487942|Secondary|Change From Baseline to Week 4 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Total Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Total score ranges from 7 to 210. The data here represents the change in Total score from Baseline to Week 4.|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
742853|NCT00487942|Secondary|Change From Baseline to Week 2 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Total Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Total score ranges from 7 to 210. The data here represents the change in Total score from Baseline to Week 2.|Baseline and 2 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 2. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
742854|NCT00487942|Secondary|Change From Baseline to Week 1 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Total Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Total score ranges from 7 to 210. The data here represents the change in Total score from Baseline to Week 1.|Baseline and 1 week following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 1. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
742855|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation Following Baseline in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Total Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Total score ranges from 7 to 210. The data here represents the change in Total score from Baseline to Endpoint.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as the number of subjects who had at least one baseline observation and one observation after baseline||Units on a scale||Standard Deviation|Mean
791380|NCT00885482|Secondary|Change of the Results of Neurocognitive Tests at 48 Weeks||48 weeks||||||
742856|NCT00487942|Secondary|Change From Baseline to Week 4 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Negative Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Negative Scale score ranges from 7 to 49. The data here represents the change in Negative Rating Scale from Baseline to Week 4.|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
742857|NCT00487942|Secondary|Change From Baseline to Week 2 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Negative Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Negative Scale score ranges from 7 to 49. The data here represents the change in Negative Rating Scale from Baseline to Week 2.|Baseline and 2 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 2. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
742858|NCT00487942|Secondary|Change From Baseline to Week 1 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Negative Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Negative Scale score ranges from 7 to 49. The data here represents the change in Negative Rating Scale from Baseline to Week 1.|Baseline and 1 week following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 1. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
742859|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Negative Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Negative Scale score ranges from 7 to 49. The data here represents the change in Negative Rating Scale from Baseline to Endpoint.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as the number of subjects who had at least one baseline observation and one observation after baseline||Units on a scale||Standard Deviation|Mean
742860|NCT00487942|Secondary|Change From Baseline to Week 4 in Scale for the Assessment of Negative Symptoms (SANS) Total Scores|SANS is a clinician-rated instrument that rates the severity of negative symptoms of schizophrenia. It contains 25 items in 5 domains: affective flattening/blunting, alogia, avolition-apathy, anhedonia-asociality, attentional impairment. Items in a domain assess symptoms and a global item assesses the overall severity of the domain. Each item is scored on a 6-point severity scale(0=Not at all, 1=questionable decrease, 2=mild, 3=moderate, 4=marked, 5=severe). The total scale ranges from 0-125. Data presented here represents change in total score from Baseline to Week 4.|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
742861|NCT00487942|Secondary|Change From Baseline to Week 2 in Scale for the Assessment of Negative Symptoms (SANS) Total Scores|SANS is a clinician-rated instrument that rates the severity of negative symptoms of schizophrenia. It contains 25 items in 5 domains: affective flattening/blunting, alogia, avolition-apathy, anhedonia-asociality, attentional impairment. Items in a domain assess symptoms and a global item assesses the overall severity of the domain. Each item is scored on a 6-point severity scale(0=Not at all, 1=questionable decrease, 2=mild, 3=moderate, 4=marked, 5=severe). The total scale ranges from 0-125. Data presented here represents change in total score from Baseline to Week 2.|Baseline and 2 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 2. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
742862|NCT00487942|Secondary|Change From Baseline to Week 1 in Scale for the Assessment of Negative Symptoms (SANS) Total Scores|SANS is a clinician-rated instrument that rates the severity of negative symptoms of schizophrenia. It contains 25 items in 5 domains: affective flattening/blunting, alogia, avolition-apathy, anhedonia-asociality, attentional impairment. Items in a domain assess symptoms and a global item assesses the overall severity of the domain. Each item is scored on a 6-point severity scale(0=Not at all, 1=questionable decrease, 2=mild, 3=moderate, 4=marked, 5=severe). The total scale ranges from 0-125. Data presented here represents change in total score from Baseline to Week 1.|Baseline and 1 week following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 1. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
743092|NCT00489216|Secondary|Complete Cutaneous Response Rate|The complete disappearance of all signs of cutaneous graft-versus-host disease. Complete cutaneous response rate + partial cutaneous response rate|On study days 29 and 57 after 4 and 8 doses of weekly subcutaneous efalizumab|||participants|||Number
742863|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in Scale for the Assessment of Negative Symptoms (SANS) Total Scores|SANS is a clinician-rated instrument that rates the severity of negative symptoms of schizophrenia. It contains 25 items in 5 domains: affective flattening/blunting, alogia, avolition-apathy, anhedonia-asociality, attentional impairment. Items in a domain assess symptoms and a global item assesses the overall severity of the domain. Each item is scored on a 6-point severity scale(0=Not at all, 1=questionable decrease, 2=mild, 3=moderate, 4=marked, 5=severe). The total scale ranges from 0-125. Data presented here represents change in total score from Baseline to Endpoint.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as the number of subjects who had at least one baseline observation and one observation after baseline||Units on a scale||Standard Deviation|Mean
742864|NCT00487942|Secondary|Patient Global Impression of Change (PGIC) at Week 4 or Last Observation Following Baseline|The PGIC is a patient-rated scale of the change in disease severity. The PGIC uses the following 7 categories and scoring assignments: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. The number of subjects who rated each category at Week 4 or at the last observation following Baseline is presented.|Week 4 or last observation following Baseline|Full analysis set defined as subjects who have at least one observation after Baseline||Participants|||Number
742865|NCT00487942|Secondary|Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Week 4 or Last Observation Following Baseline|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The CGI-S was assessed at Baseline, Week 1, Week 2 and Week 4. Data is presented representing the number of subjects who rated each CGI-S score at Endpoint which is Week 4 or the last observation following Baseline.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as the number of subjects who had at least one observation after baseline||Participants|||Number
742866|NCT00487942|Secondary|Change From Baseline to Week 4 in the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Global Rating|The SCoRS is an 18-item interview based assessment covering all the cognitive domains in the MATRICS Consensus Cognitive Battery except social cognition. It is administered separately to the patient and an informant (family or friend) who are asked to rate the patient's level of difficulty in performing various cognitive functions on a 4-point scale (higher rating = greater impairment). They also complete a global assessment of cognitive function on a 1-10 scale. The interviewer factors in their own assessment on both the 18-items (Total Score) and the global assessment for the final score.|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose interviewers completed an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Error|Mean
742867|NCT00487942|Secondary|Change From Baseline to Week 2 in the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Global Rating|n The SCoRS is an 18-item interview based assessment covering all the cognitive domains in the MATRICS Consensus Cognitive Battery except social cognition. It is administered separately to the patient and an informant (family or friend) who are asked to rate the patient's level of difficulty in performing various cognitive functions on a 4-point scale (higher rating = greater impairment). They also complete a global assessment of cognitive function on a 1-10 scale. The interviewer factors in their own assessment on both the 18-items (Total Score) and the global assessment for the final score.|Baseline and 2 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose interviewers completed an efficacy assessment at week 2. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
742868|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Global Rating|The SCoRS is an 18-item interview based assessment covering all the cognitive domains in the MATRICS Consensus Cognitive Battery except social cognition. It is administered separately to the patient and an informant (family or friend) who are asked to rate the patient's level of difficulty in performing various cognitive functions on a 4-point scale (higher rating = greater impairment). They also complete a global assessment of cognitive function on a 1-10 scale. The interviewer factors in their own assessment on both the 18-items (Total Score) and the global assessment for the final score.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and whose interviewers completed an efficacy assessment at least once after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
742869|NCT00487942|Secondary|Change From Baseline to Week 4 in the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Total Scores|The SCoRS is an 18-item interview based assessment covering all the cognitive domains in the MATRICS Consensus Cognitive Battery except social cognition. It is administered separately to the patient and an informant (family or friend) who are asked to rate the patient's level of difficulty in performing various cognitive functions on a 4-point scale (higher rating = greater impairment). They also complete a global assessment of cognitive function on a 1-10 scale. The interviewer factors in their own assessment on both the 18-items (Total Score) and the global assessment for the final score.|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and who had an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
742887|NCT00487942|Other Pre-specified|Change From Baseline to Week 4 or Last Observation Following Baseline in the Barnes Akathisia Scale (BARS) Total Score|The BARS is a 4-item clinician-rated scale to measure the presence and severity of drug-induced akathisia. Items related to the assessment of objective akathisia, subjective awareness of restlessness, and distress related to restlessness are rated using various 4-point (0 - 3) scales. A global assessment of akathisia is rated using a 6-point (0=Absent, 1=Questionable akathisia, 2=Mild akathisia, 3=Moderate akathisia, 4=Marked akathisia, 5=Severe akathisia) scale. The total score range is from 0 to 14 with a higher score indicating more severe akathisia.|Baseline and 4 weeks (or last observation after Baseline)|Safety Analysis Set defined as subjects who had at least one dose of study medication and an observation at baseline and at least one observation after baseline.||Units on a scale||Standard Deviation|Mean
742870|NCT00487942|Secondary|Change From Baseline to Week 2 in the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Total Scores|The SCoRS is an 18-item interview based assessment covering all the cognitive domains in the MATRICS Consensus Cognitive Battery except social cognition. It is administered separately to the patient and an informant (family or friend) who are asked to rate the patient's level of difficulty in performing various cognitive functions on a 4-point scale (higher rating = greater impairment). They also complete a global assessment of cognitive function on a 1-10 scale. The interviewer factors in their own assessment on both the 18-items (Total Score) and the global assessment for the final score.|Baseline and 2 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and who had an efficacy assessment at week 2. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
742871|NCT00487942|Secondary|Change From Baseline to Endpoint (Week 4 or Last Observation After Baseline) in the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Total Scores|The SCoRS is an 18-item interview based assessment covering all the cognitive domains in the MATRICS Consensus Cognitive Battery except social cognition. It is administered separately to the patient and an informant (family or friend) who are asked to rate the patient's level of difficulty in performing various cognitive functions on a 4-point scale (higher rating = greater impairment). They also complete a global assessment of cognitive function on a 1-10 scale. The interviewer factors in their own assessment on both the 18-items (Total Score) and the global assessment for the final score.|Baseline and Week 4 or last observation after baseline|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
742872|NCT00487942|Secondary|Change From Baseline to Week 4 in the Maximum Value for Actigraphy Data of Total Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 4 in total activity.|Baseline and Week 4|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 4||Counts||Standard Deviation|Mean
742873|NCT00487942|Secondary|Change From Baseline to Week 3 in the Maximum Value for Actigraphy Data of Total Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 3 in total activity.|Baseline and Week 3|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 3||Counts||Standard Deviation|Mean
742874|NCT00487942|Secondary|Change From Baseline to Week 2 in the Maximum Value for Actigraphy Data of Total Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 2 in total activity.|Baseline and Week 2|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 2||Counts||Standard Deviation|Mean
742875|NCT00487942|Secondary|Change From Baseline to Week 1 in the Maximum Value for Actigraphy Data of Total Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to week 1 in total activity.|Baseline and Week 1|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 1||Counts||Standard Deviation|Mean
742876|NCT00487942|Secondary|Change From Baseline to Endpoint (Week 4 or Last Observation After Baseline) in the Maximum Value for Actigraphy Data of Total Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Endpoint in total activity.|Baseline and Week 4 or last observation after baseline|Full analysis set defined as subjects who had at least one assessment by actigraphy after baseline||Counts||Standard Deviation|Mean
742877|NCT00487942|Other Pre-specified|Change From Baseline to Week 4 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Positive Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Positive Scale score ranges from 7 to 49. The data here represents the change in Positive Rating Scale from Baseline to Week 4.|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
742878|NCT00487942|Other Pre-specified|Change From Baseline to Week 2 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Positive Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Positive Scale score ranges from 7 to 49. The data here represents the change in Positive Rating Scale from Baseline to Week 2.|Baseline and 2 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 2. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
743346|NCT00496782|Secondary|Change in Detectable Tropism From Screening|Number of subjects who switch their tropism status from screening to Baseline|Screening (Day -21 to 0), Baseline.|Study was canceled with only 16 subjects of 60 subjects required to enroll.||Participants|||Number
742879|NCT00487942|Other Pre-specified|Change From Baseline to Week 1 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Positive Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Positive Scale score ranges from 7 to 49. The data here represents the change in Positive Rating Scale from Baseline to Week 1.|Baseline and 1 week following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 1. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
742880|NCT00487942|Other Pre-specified|Change From Baseline to Week 4 or Last Observation After Baseline in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Positive Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Positive Scale score ranges from 7 to 49. The data here represents the change in Positive Rating Scale from Baseline to Endpoint.|Baseline and 4 weeks (or last observation after Baseline)|Safety Analysis Set defined as subjects who had at least one dose of study medication and an observation at baseline and at least one observation after baseline.||Units on a scale||Standard Deviation|Mean
742881|NCT00487942|Other Pre-specified|Change From Baseline to Week 4 on the Calgary Depression Scale for Schizophrenia (CDSS) Total Score|The CDSS is a clinician-rated scale that assesses the level of depression in patients with schizophrenia. Each of the 9 items is scored on a 4-point scale (0=absent, 1=mild, 2=moderate, 3=severe). The total score range is 0 - 27. The data presented here represents the change from Baseline to Week 4 in the total score.|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
742882|NCT00487942|Other Pre-specified|Change From Baseline to Week 2 on the Calgary Depression Scale for Schizophrenia (CDSS) Total Score|The CDSS is a clinician-rated scale that assesses the level of depression in patients with schizophrenia. Each of the 9 items is scored on a 4-point scale (0=absent, 1=mild, 2=moderate, 3=severe). The total score range is 0 - 27. The data presented here represents the change from Baseline to Week 2 in the total score.|Baseline and 2 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 2. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
742883|NCT00487942|Other Pre-specified|Change From Baseline to Week 4 or Last Observation After Baseline on the Calgary Depression Scale for Schizophrenia (CDSS) Total Score|The CDSS is a clinician-rated scale that assesses the level of depression in patients with schizophrenia. Each of the 9 items is scored on a 4-point scale (0=absent, 1=mild, 2=moderate, 3=severe). The total score range is 0 - 27. The data presented here represents the change from Baseline to Week 4 or the last observation following baseline in the total score.|Baseline and 4 weeks (or last observation after Baseline)|Safety Analysis Set defined as subjects who had at least one dose of study medication and an observation at baseline and at least one observation after baseline.||Units on a scale||Standard Deviation|Mean
742884|NCT00487942|Other Pre-specified|Change From Baseline to Week 4 in the Barnes Akathisia Scale (BARS) Total Score|The BARS is a 4-item clinician-rated scale to measure the presence and severity of drug-induced akathisia. Items related to the assessment of objective akathisia, subjective awareness of restlessness, and distress related to restlessness are rated using various 4-point (0 - 3) scales. A global assessment of akathisia is rated using a 6-point (0=Absent, 1=Questionable akathisia, 2=Mild akathisia, 3=Moderate akathisia, 4=Marked akathisia, 5=Severe akathisia) scale. The total score range is from 0 to 14 with a higher score indicating more severe akathisia.|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Error|Mean
742885|NCT00487942|Other Pre-specified|Change From Baseline to Week 2 in the Barnes Akathisia Scale (BARS) Total Score|The BARS is a 4-item clinician-rated scale to measure the presence and severity of drug-induced akathisia. Items related to the assessment of objective akathisia, subjective awareness of restlessness, and distress related to restlessness are rated using various 4-point (0 - 3) scales. A global assessment of akathisia is rated using a 6-point (0=Absent, 1=Questionable akathisia, 2=Mild akathisia, 3=Moderate akathisia, 4=Marked akathisia, 5=Severe akathisia) scale. The total score range is from 0 to 14 with a higher score indicating more severe akathisia.|Baseline and 2 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 2. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
742886|NCT00487942|Other Pre-specified|Change From Baseline to Week 1 in the Barnes Akathisia Scale (BARS) Total Score|The BARS is a 4-item clinician-rated scale to measure the presence and severity of drug-induced akathisia. Items related to the assessment of objective akathisia, subjective awareness of restlessness, and distress related to restlessness are rated using various 4-point (0 - 3) scales. A global assessment of akathisia is rated using a 6-point (0=Absent, 1=Questionable akathisia, 2=Mild akathisia, 3=Moderate akathisia, 4=Marked akathisia, 5=Severe akathisia) scale. The total score range is from 0 to 14 with a higher score indicating more severe akathisia.|Baseline and 1 week following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 1. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
762934|NCT00659360|Secondary|Stable Disease Rate|Achieved stable disease as their best response|Up to 5 years|||participants|||Number
742888|NCT00487942|Other Pre-specified|Change From Baseline to Week 4 in the Modified Simpson-Angus Scale Total Score|The Modified Simpson Angus Scale is a clinician-rated scale to assess the presence and severity of extrapyramidal symptoms associated study drug treatment. This is a 10-item scale that focuses on rigidity. The items are rated using a 5-point (0 - 4) scale. The total score ranges between 0 and 40. The data presented here represents the change from Baseline to Week 4.|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
742889|NCT00487942|Other Pre-specified|Change From Baseline to Week 2 in the Modified Simpson-Angus Scale Total Score|The Modified Simpson Angus Scale is a clinician-rated scale to assess the presence and severity of extrapyramidal symptoms associated study drug treatment. This is a 10-item scale that focuses on rigidity. The items are rated using a 5-point (0 - 4) scale. The total score ranges between 0 and 40. The data presented here represents the change from Baseline to Week 2.|Baseline and 2 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 1. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
742890|NCT00487942|Other Pre-specified|Change From Baseline to Week 1 in the Modified Simpson-Angus Scale Total Score|The Modified Simpson Angus Scale is a clinician-rated scale to assess the presence and severity of extrapyramidal symptoms associated study drug treatment. This is a 10-item scale that focuses on rigidity. The items are rated using a 5-point (0 - 4) scale. The total score ranges between 0 and 40. The data presented here represents the change from Baseline to Week 1.|Baseline and 1 week following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 1. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
742891|NCT00487942|Other Pre-specified|Change From Baseline to Week 4 or Last Observation After Baseline in the Modified Simpson-Angus Scale Total Score|The Modified Simpson Angus Scale is a clinician-rated scale to assess the presence and severity of extrapyramidal symptoms associated study drug treatment. This is a 10-item scale that focuses on rigidity. The items are rated using a 5-point (0 - 4) scale. The total score ranges between 0 and 40. The data presented here represents the change from Baseline to Week 4 or the last observation following baseline.|Baseline and 4 weeks (or last observation after Baseline)|Safety Analysis Set defined as subjects who had at least one dose of study medication and an observation at baseline and at least one observation after baseline||Units on a scale||Standard Deviation|Mean
742892|NCT00487942|Secondary|Change From Baseline to Week 4 in the Minimum Value for Actigraphy Data of Total Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to week 4 in total activity.|Baseline and Week 4|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 4||Counts||Standard Deviation|Mean
742893|NCT00487942|Secondary|Change From Baseline to Week 3 in the Minimum Value for Actigraphy Data of Total Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 3 in total activity.|Baseline and Week 3|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 3||Counts||Standard Deviation|Mean
742894|NCT00487942|Secondary|Change From Baseline to Week 2 in the Minimum Value for Actigraphy Data of Total Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 2 in total activity.|Baseline and Week 2|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 2||Counts||Standard Deviation|Mean
742895|NCT00487942|Secondary|Change From Baseline to Week 1 in the Minimum Value for Actigraphy Data of Total Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 1 in total activity.|Baseline and Week 1|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 1||Counts||Standard Deviation|Mean
742896|NCT00487942|Secondary|Change From Baseline to Endpoint (Week 4 or Last Observation After Baseline) in the Minimum Value for Actigraphy Data of Total Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Endpoint in total activity.|Baseline and Week 4 or last observation after baseline|Full analysis set defined as subjects who had at least one assessment by actigraphy after baseline||Counts||Standard Deviation|Mean
742897|NCT00487942|Secondary|Change From Baseline to Week 4 in the Median Value for Actigraphy Data of Total Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 4 in total activity.|Baseline and Week 4|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 4||Counts||Standard Deviation|Mean
742898|NCT00487942|Secondary|Change From Baseline to Week 3 in the Median Value for Actigraphy Data of Total Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 3 in total activity.|Baseline and Week 3|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 3||Counts||Standard Deviation|Mean
763024|NCT00652145|Primary|Fecal Calprotectin Level <50µg/g||6 weeks after randomization|||participants|||Number
742900|NCT00487942|Secondary|Change From Baseline to Week 1 in the Median Value for Actigraphy Data of Total Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to week 1 in total activity.|Baseline and Week 1|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 1||Counts||Standard Deviation|Mean
742901|NCT00487942|Secondary|Change From Baseline to Endpoint (Week 4 or Last Observation After Baseline) in the Median Value for Actigraphy Data of Total Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Endpoint in total activity.|Baseline and Week 4 or last observation after baseline|Full analysis set defined as subjects who had at least one assessment by actigraphy after baseline||Counts||Standard Deviation|Mean
742902|NCT00487942|Secondary|Change From Baseline to Week 4 in the Median Value for Actigraphy Data of Standard Deviation of Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to week 4 in standard deviation of activity (counts/epoch).|Baseline and Week 4|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 4||Counts||Standard Deviation|Mean
742903|NCT00487942|Secondary|Change From Baseline to Week 3 in the Median Value for Actigraphy Data of Standard Deviation of Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 3 in standard deviation of activity (counts/epoch).|Baseline and Week 3|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 3||Counts||Standard Deviation|Mean
742904|NCT00487942|Secondary|Change From Baseline to Week 2 in the Median Value for Actigraphy Data of Standard Deviation of Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 2 in standard deviation of activity (counts/epoch).|Baseline and Week 2|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 2||Counts||Standard Deviation|Mean
742905|NCT00487942|Secondary|Change From Baseline to Week 1 in the Median Value for Actigraphy Data of Standard Deviation of Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 1 in standard deviation of activity (counts/epoch).|Baseline and Week 1|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 1||Counts||Standard Deviation|Mean
742906|NCT00487942|Secondary|Change From Baseline to Endpoint (Week 4 or Last Observation After Baseline) in the Median Value for Actigraphy Data of Standard Deviation of Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to endpoint in standard deviation of activity (counts/epoch).|Baseline and Week 4 or last observation after baseline|Full analysis set defined as subjects who had at least one assessment by actigraphy after baseline||Counts||Standard Deviation|Mean
742907|NCT00487942|Secondary|Change From Baseline to Week 4 in the Median Value for Actigraphy Data of Maximum Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to week 4 in maximum activity.|Baseline and Week 4|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 4||Counts||Standard Deviation|Mean
742908|NCT00487942|Secondary|Change From Baseline to Week 3 in the Median Value for Actigraphy Data of Maximum Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 3 in maximum activity.|Baseline and Week 3|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 3||Counts||Standard Deviation|Mean
742909|NCT00487942|Secondary|Change From Baseline to Week 2 in the Median Value for Actigraphy Data of Maximum Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 2 in maximum activity.|Baseline and Week 2|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 2||Counts||Standard Deviation|Mean
742910|NCT00487942|Secondary|Change From Baseline to Week 1 in the Median Value for Actigraphy Data of Maximum Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 1 in maximum activity.|Baseline and Week 1|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 1||Counts||Standard Deviation|Mean
742911|NCT00487942|Secondary|Change From Baseline to Endpoint (Week 4 or Last Observation After Baseline) in the Median Value for Actigraphy Data of Maximum Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline in maximum activity to Endpoint.|Baseline and Week 4 or last observation after baseline|Full analysis set defined as subjects who had at least one assessment by actigraphy after baseline||Counts||Standard Deviation|Mean
742912|NCT00487942|Secondary|Change From Baseline to Week 4 in the Median Value for Actigraphy Data of Average Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline in average activity per epoch (counts/epoch) to Week 4.|Baseline and Week 4|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 4||Counts||Standard Deviation|Mean
742913|NCT00487942|Secondary|Change From Baseline to Week 3 in the Median Value for Actigraphy Data of Average Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline in average activity per epoch (counts/epoch) to Week 3.|Baseline and Week 3|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 3||Counts||Standard Deviation|Mean
742914|NCT00487942|Secondary|Change From Baseline to Week 2 in the Median Value for Actigraphy Data of Average Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline in average activity per epoch (counts/epoch) to Week 2.|Baseline and Week 2|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 2||Counts||Standard Deviation|Mean
742915|NCT00487942|Secondary|Change From Baseline to Week 1 in the Median Value for Actigraphy Data of Average Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline in average activity per epoch (counts/epoch)to Week 1.|Baseline and Week 1|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 1||Counts||Standard Deviation|Mean
742916|NCT00487942|Secondary|Change From Baseline to Endpoint (Week 4 or Last Observation After Baseline) in the Median Value for Actigraphy Data of Average Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline in average activity per epoch (counts/epoch).|Baseline and Week 4 or last observation after baseline|Full analysis set defined as subjects who had a baseline and at least one post-baseline assessment by actigraphy||Counts||Standard Deviation|Mean
742917|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Trails B Test|Trail B is an instrument designed to assess set shifting. The patient was given a paper with numbers and letters on it and asked to connect them in an alternating manner (eg. 1-A-2-B-3C). The time required for the patient to complete the test was recorded. The change from Baseline to last observation following Baseline in the time necessary to complete the test is presented here.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.||Minutes||Standard Deviation|Mean
742918|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Wisconsin Card Sort Test (WCST) - Categories Completed|"WCST is an instrument administered electronically to assess abstract reasoning and ability to alter problem solving strategies. Patients are given 64 response cards and 4 stimulus cards and asked to match each stimulus card to 1 pile of response cards. The patient is not told how to match the cards, only right or wrong to each placement. Examiner may change matching rules (sorting categories) during the test at which time the subject must alter their sorting category. The change from baseline in number of sorting categories achieved was assessed."|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.||Categories Completed||Standard Deviation|Mean
742919|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Wisconsin Card Sort Test (WCST) - Consecutive Responses on the Final Category|"WCST is an instrument administered electronically to assess abstract reasoning and ability to alter problem solving strategies. Patients are given 64 response cards and 4 stimulus cards and asked to match each stimulus card to 1 pile of response cards. The patient is not told how to match the cards, only right or wrong to each placement. Examiner may change matching rules (sorting categories) during the test at which time the subject must alter their sorting category. The change from baseline in number of consecutive responses on the final category was assessed."|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.||Responses||Standard Deviation|Mean
742920|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Wisconsin Card Sort Test (WCST) - Number of Perseverative Errors|"WCST is an instrument administered electronically to assess abstract reasoning and ability to alter problem solving strategies. Patients are given 64 response cards and 4 stimulus cards and asked to match each stimulus card to 1 pile of response cards. The patient is not told how to match the cards, only right or wrong to each placement. Examiner may change matching rules during the test. Perseveration errors occur when subject repeats the same error no matter how many times they are told the placement is wrong. The change from baseline in number of perseveration errors was assessed."|4 weeks (or last observation after baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.||Errors||Standard Deviation|Mean
743105|NCT00489255|Secondary|Median Time to 'on' for Visit 4/End of Period 2 Injection|Time to “on” (relief of immobility) was measured 20 minutes after administration of Apokyn and before discharge at the clinic; calculated as the difference between the recorded time of “on” and time of injection.|Day 56 (Visit 4)|||minutes||95% Confidence Interval|Median
791381|NCT00885482|Secondary|Change of Metabolic Parameters at 48 Weeks||48 weeks||||||
742921|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Letter-Number Span (LNS) Test of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery|The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The LNS is a component of the Working Memory Domain scored on a normative scale to derive a T-score, (mean is 50 and standard deviation is 10). The data here represent the mean change in LNS T-score from baseline to last observation after baseline.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
742922|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Wechsler Memory Scale: Spatial Span (WMS-III SS) Test of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery|The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The WMS-III SS is a component of the Working Memory Domain scored on a normative scale to derive a T-score, (mean is 50 and standard deviation is 10). The data here represent the mean change in WMS-III SS T-score from baseline to last observation after baseline.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
742923|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Fluency Test of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery|The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Fluency Test is a component of the Speed of Processing Domain scored on a normative scale to derive a T-score, (mean is 50 and standard deviation is 10). The data here represent the mean change in Fluency Test T-score from baseline to last observation after baseline.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
742924|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Brief Assessment of Cognition in Schizophrenia: Symbol Coding (BASC SC) Test of the MATRICS Consensus Cognitive Battery|The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The BASC SC Test is a component of the Speed of Processing Domain scored on a normative scale to derive a T-score, (mean is 50 and standard deviation is 10). The data here represent the mean change in BASC SC Test T-score from baseline to last observation after baseline.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
742925|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Trail Making Test of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery|The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Trail Making Test is a component of the Speed of Processing Domain scored on a normative scale to derive a T-score, (mean is 50 and standard deviation is 10). The data here represent the mean change in Trail Making Test T-score from baseline to last observation after baseline.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
742926|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Social Cognition Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery|The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Domain score combines the individual test scores of the Domain and scores them on a normative scale to derive a T-score, (mean is 50 and standard deviation is 10) for the composite. The data here represent the mean change in Social Cognition Domain T-score from baseline to last observation after baseline.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
742951|NCT00488293|Primary|Skindex-16 Change Scores Between Baseline and Month 9 - Functioning Scores|"Skindex-16 Change Scores. Skindex-16 is a quality of life measure that assesses bother. It includes the domains of symptoms, emotions, and functioning. A composite (total) score can also be calculated. The range of scores are 0 (never bothered) to 100 (always bothered) for subscale and composite scores. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant."|Baseline to Month 9|Baseline to Month 9 Skindex-16 change scores - Functioning Scores||units on a scale||Standard Deviation|Mean
743347|NCT00496782|Secondary|Change in Lymphocyte Subsets; CD4 and CD8 From Screening.|Calculated avergae of {CD4 or CD8 at Day 1 - CD4 or CD8 at Screening}|Screening (Day -14 to 0), Day 1.|Study was canceled with only 16 subjects of 60 subjects required to enroll.||cells/µL||Standard Deviation|Mean
742927|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Reasoning and Problem Solving Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery|The MATRICS Consensus Cognitive Battery is an instrument containing 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Domain score combines the individual test scores of the Domain and scores them on a normative scale to derive a T-score, (mean is 50 and standard deviation is 10) for the composite. The data here represent the mean change in Reasoning and Problem Solving Domain T-score from baseline to last observation after baseline.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
742928|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Visual Learning Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery|The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Domain score combines the individual test scores of the Domain and scores them on a normative scale to derive a T-score, where the mean is 50 and a standard deviation is 10 for the composite. The data here represent the mean change in Visual Learning Domain T-score from baseline to last observation after baseline.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
742929|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Verbal Learning Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery|The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Domain score combines the individual test scores of the Domain and scores them on a normative scale to derive a T-score, where the mean is 50 and a standard deviation is 10 for the composite. The data here represent the mean change in Verbal Learning Domain T-score from baseline to last observation after baseline.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
742930|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Working Memory Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery|The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Domain score combines the individual test scores of the Domain and scores them on a normative scale to derive a T-score, where the mean is 50 and a standard deviation is 10 for the composite. The data here represent the mean change in Working Memory Domain T-score from baseline to last observation after baseline.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
742931|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Attention/Vigilance Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery|The MATRICS Consensus Cognitive Battery is an instrument containing 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Domain score combines the individual test scores of the Domain and scores them on a normative scale to derive a T-score, where the mean is 50 and a standard deviation is 10 for the composite. The data here represent the mean change in Attention/Vigilance Domain T-score from baseline to last observation after baseline.|Baseline and 4 weeks (or last observation after baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
742932|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Speed of Processing Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery|The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Domain score combines the individual test scores of the Domain and scores them on a normative scale to derive a T-score, where the mean is 50 and a standard deviation is 10 for the composite. The data here represent the mean change in Processing Speed Domain T-score from baseline to last observation after baseline.|Baseline 4 weeks (or last observation after baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
742952|NCT00488293|Primary|Skindex-16 Change Scores Between Baseline to Month 3 - Emotions Score|"Skindex-16 Change Scores. Skindex-16 is a quality of life measure that assesses bother. It includes the domains of symptoms, emotions, and functioning. A composite (total) score can also be calculated. The range of scores are 0 (never bothered) to 100 (always bothered) for subscale and composite scores. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant."|Baseline to Month 3|Baseline to Month 3 Skindex-16 change scores - Emotions Score||units on a scale||Standard Deviation|Mean
742933|NCT00487942|Secondary|Change From Baseline to Week 4 in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery Composite Score|The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The composite score combines the individual scores of the 10 tests and scores them on a normative scale to derive a T-score, where the mean is 50 and a standard deviation is 10 for the composite. The data here represent the mean change in composite T-score from baseline to 4 weeks.|Baseline and 4 weeks|Full analysis set defined as subjects who received one or more doses of the study drug and who had a MATRICS efficacy assessment at baseline and at Week 4. If any part of the composite score was missing then the composite score was set to missing. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
742934|NCT00487942|Primary|Mean Change From Baseline to Last Observation After Baseline in Composite Score on the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery|The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The composite score combines the individual scores of the 10 tests and scores them on a normative scale to derive a T-score, where the mean is 50 and a standard deviation is 10 for the composite. The data here represents the change from baseline to last observation after baseline in Composite T-Score.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. If any part of the composite score was missing then the composite score was set to missing. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
742935|NCT00487981|Primary|Pain Rating at 6 Months Post Activation Compared to Baseline||6 months|||Percent reduction||Standard Deviation|Mean
742936|NCT00488033|Secondary|Number of Participants With Limb Amputation or Peripheral Vascular Revascularization Procedure||4 years|||Participants|||Count of Participants
742937|NCT00488033|Secondary|Number of Participants With Stroke or Carotid Revascularization Procedure||4 years|||Participants|||Count of Participants
742938|NCT00488033|Secondary|Number of Participants With Hospitalization for Heart Failure||4 years|||Participants|||Count of Participants
742939|NCT00488033|Secondary|Number of Participants With Combination of Coronary Death, Non-fatal MI, and Unstable Angina With Hospitalization||4 years|||Participants|||Count of Participants
742940|NCT00488033|Secondary|Number of Participants Suffering Cardiovascular (CV) Death||4 years|||Participants|||Count of Participants
742941|NCT00488033|Primary|Number of Participants With Combination of All Cause Death, Non-fatal Myocardial Infarction (MI), and Hospitalization for Unstable Angina||4 years|||Participants|||Count of Participants
742942|NCT00488059|Secondary|Percentage of Patients With Ongoing Injection Site Reactions (ISRs)||Phase I and II|||Percentage of patients|||Number
742943|NCT00488059|Secondary|CD4+ Lymphocyte Count Change From Baseline|"Change from study Phase I baseline in CD4+ lymphocyte count at Phase II study Weeks II - 1, 12, 16, and LOCF by treatment arm.
Change from study Phase II baseline in CD4+ lymphocyte count at Phase II study weeks II – 12 and 16."|Phase I Baseline and Phase II Weeks II-1, 12, 16, and LOCF|Intent-to-treat||cells/mm3||Full Range|Median
742944|NCT00488059|Secondary|Virologic Response Over Time in Phase II of the Study|The number of intent-to-treat (ITT) participants with HIV-1 RNA <= 50 copies/mL and HIV-1 RNA < 400 copies/mL by study week.|Weeks II-4, 8, 12 & 16|intent-to-treat population||participants|||Number
742945|NCT00488059|Secondary|HIV-1 RNA Viral Load Change From Baseline in Phase I of the Study|Change from baseline in HIV-1 RNA (log10 copies/mL) at study Weeks I-4, 8, 12 & LOCF for ITT patients in Phase I of the study|Baseline and Weeks 4, 8, 12 & LOCF|Intent-to-treat population. Last Observation Carried Forward (LOCF) includes non-missing data values from the last post-baseline visit for each participant which was carried forward to impute missing data values.||log10 copies/mL||Standard Deviation|Mean
742946|NCT00488059|Primary|Number of Patients in Phase II of the Study With HIV-1 RNA ≤ 50 Copies/mL at Week II-16||Week II-16|Intent-to-treat population||participants|||Number
742947|NCT00488059|Secondary|Virologic Response Over Time in Phase I of the Study|The number of intent-to-treat (ITT) participants with HIV-1 RNA <= 50 copies/mL and HIV-1 RNA < 400 copies/mL by study week are summarized below.|Weeks 4, 8 & 12|Intent-to-treat population||participants|||Number
742948|NCT00488059|Primary|Number of Patients in Phase I of the Study With a Confirmed HIV-1 RNA Viral Load ≤ 50 Copies/mL|Virologic responders were defined as patients who had an initial HIV-1 RNA assessment <= 50 copies/mL during Phase I at any visit between Week I-4 and Week I-12 and a confirmatory viral load assessment ≤ 50 copies/mL at the next visit (Week I-8 to Week II-16)|Between Week I-4 and Week I-12 of Phase I of the study|Intent-to-treat population||participants|||Number
742949|NCT00488293|Secondary|Clinical Course Rating Between Baseline and First Clinic Visit|Clinical course was assessed by review of serial digital images. The clinical course rating was provided by consensus opinion provided by a panel of three dermatologists that were not otherwise involved in the study. The rating categories were resolved, improved, unchanged - not clinically relevant, unchanged - clinically relevant, and worse.|Baseline to First Clinic Visit|Clinical course rating between baseline and first clinic visit, if a visit occurred. Timeframe varied and only applied if a first clinic visit occurred.||participants|||Number
742950|NCT00488293|Primary|Skindex-16 Change Scores Between Baseline and Month 3 - Functioning Score|"Skindex-16 Change Scores. Skindex-16 is a quality of life measure that assesses bother. It includes the domains of symptoms, emotions, and functioning. A composite (total) score can also be calculated. The range of scores are 0 (never bothered) to 100 (always bothered) for subscale and composite scores. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant."|Baseline to Month 3|Baseline to Month 3 Skindex-16 change scores - Functioning Scores||units on a scale||Standard Deviation|Mean
743348|NCT00496782|Secondary|Change in Lymphocyte Subset CD8 From Day 1|Calculated average of CD8 at Day 7, 14, 28 and Week 24 minus CD8 at Day 1|Day 1(Baseline), Day 7, 14, 28 and Weeks 24|Study was canceled with only 16 subjects of 60 subjects required to enroll.||cells/µL||Standard Deviation|Mean
742953|NCT00488293|Primary|Skindex-16 Change Scores Between Baseline and Month 9 - Emotions Score|"Skindex-16 Change Scores. Skindex-16 is a quality of life measure that assesses bother. It includes the domains of symptoms, emotions, and functioning. A composite (total) score can also be calculated. The range of scores are 0 (never bothered) to 100 (always bothered) for subscale and composite scores. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant."|Baseline to Month 9|Baseline to Month 9 Skindex-16 change score - Emotions Score||units on a scale||Standard Deviation|Mean
742954|NCT00488293|Primary|Skindex-16 Changes Scores Baseline to Month 3 - Symptoms Score|"Skindex-16 Change Scores. Skindex-16 is a quality of life measure that assesses bother. It includes the domains of symptoms, emotions, and functioning. A composite (total) score can also be calculated. The range of scores are 0 (never bothered) to 100 (always bothered) for subscale and composite scores. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant."|Baseline to Month 3|Baseline to Month 3 Skindex-16 change score - Symptoms Score||units on a scale||Standard Deviation|Mean
742955|NCT00488293|Primary|Skindex-16 Change Scores Baseline to Month 9 - Symptoms Score|"Skindex-16 Change Scores. Skindex-16 is a quality of life measure that assesses bother. It includes the domains of symptoms, emotions, and functioning. A composite (total) score can also be calculated. The range of scores are 0 (never bothered) to 100 (always bothered) for subscale and composite scores. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant."|Baseline to Month 9|Baseline to Month 9 Skindex-16 change scores - Symptoms Score||units on a scale||Standard Deviation|Mean
742956|NCT00488293|Primary|Skindex-16 Change Scores Baseline to Month 3 - Composite Score|"Skindex-16 Change Scores. Skindex-16 is a quality of life measure that assesses bother. It includes the domains of symptoms, emotions, and functioning. A composite (total) score can also be calculated. The range of scores are 0 (never bothered) to 100 (always bothered) for subscale and composite scores. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant."|Baseline to Month 3|Baseline to Month 3 Skindex-16 change scores - Composite Score||units on a scale||Standard Deviation|Mean
742957|NCT00488293|Secondary|Clinical Course Rating Between Baseline and Month 9|Clinical course was assessed by review of serial digital images. The clinical course rating was provided by consensus opinion provided by a panel of three dermatologists that were not otherwise involved in the study. The rating categories were resolved, improved, unchanged - not clinically relevant, unchanged - clinically relevant, and worse.|Baseline to Month 9|Clinical course rating between baseline and month 9||participants|||Number
742958|NCT00488293|Primary|Skindex-16 Change Scores Between Baseline to Month 9 - Composite Score|"Skindex-16 Change Scores. Skindex-16 is a quality of life measure that assesses bother. It includes the domains of symptoms, emotions, and functioning. A composite (total) score can also be calculated. The range of scores are 0 (never bothered) to 100 (always bothered) for subscale and composite scores. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant."|Baseline to Month 9|Baseline to Month 9 Skindex-16 change scores - Composite Score.||units on a scale||Standard Deviation|Mean
742959|NCT00488319|Secondary|Change From Open-label Baseline to Open-label Endpoint in the Sleep Visual Analog Scale (VAS): Daytime Drowsiness - Last Observation Carried Forward|Sleep VAS is a self administered scale that rates the quality of sleep and daytime drowsiness. Participants make a mark on a line to represent how well they have slept in the previous 7 days (“very badly” to “very well”) and how often they have felt drowsy within the previous 7 days (“not at all” to “all the time”). The score for each item ranges from 0 to 100 mm. For quality of sleep, a score of 0 indicates “Very badly” and a score of 100 indicates “Very well.” For daytime drowsiness, a score of 0 indicates “Not at all” and a score of 100 indicates “All the time.” Improvement of the condition is indicated by the positive change for the quality of sleep and the negative change for the daytime drowsiness.|Baseline, Week 104 or the last post-baseline assessment|The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set.||Scores on a scale||Standard Deviation|Mean
742960|NCT00488319|Secondary|Change From Open-label Baseline to Open-label Endpoint in the Sleep Visual Analog Scale (VAS): Quality of Sleep - Last Observation Carried Forward|Sleep VAS is a self administered scale that rates the quality of sleep and daytime drowsiness. Participants make a mark on a line to represent how well they have slept in the previous 7 days (“very badly” to “very well”) and how often they have felt drowsy within the previous 7 days (“not at all” to “all the time”). The score for each item ranges from 0 to 100 mm. For quality of sleep, a score of 0 indicates “Very badly” and a score of 100 indicates “Very well.” For daytime drowsiness, a score of 0 indicates “Not at all” and a score of 100 indicates “All the time.” Improvement of the condition is indicated by the positive change for the quality of sleep and the negative change for the daytime drowsiness.|Baseline, Week 104 or the last post-baseline assessment|The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set.||Scores on a scale||Standard Deviation|Mean
742961|NCT00488319|Secondary|Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Executive Functioning (Reasoning and Problem Solving) Domain Test Variable - Wisconsin Card Sort Test-Total Errors: Scaled - Last Observation Carried Forward|A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance.|Baseline, Week 24|The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set.||Scores on a scale||Standard Deviation|Mean
743404|NCT00497198|Secondary|Change From Baseline in Low Density Lipoprotein Cholesterol(LDL-c) at Week 12||12 weeks (baseline to week 12)|||mg/dL||Standard Error|Mean
755231|NCT00593346|Primary|Local Control Using Ipsilateral Breast Tumor Recurrence Rates||2 years after treatment completion|||percentage of participants|||Number
742962|NCT00488319|Secondary|Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Executive Functioning (Reasoning and Problem Solving) Domain Test Variable, Trials Part B Time, Scaled - Last Observation Carried Forward|A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance.|Baseline, Week 24|The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set.||Scores on a scale||Standard Deviation|Mean
742963|NCT00488319|Secondary|Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Speed of Processing Domain Test Variable Semantic Verbal Fluency, Scaled - Last Observation Carried Forward|A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance.|Baseline, Week 24|The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set.||Scores on a scale||Standard Deviation|Mean
742964|NCT00488319|Secondary|Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Speed of Processing Domain Test Variable Phonetic Verbal Fluency: Scaled - Last Observation Carried Forward|A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance.|Baseline, Week 24|The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set.||Scores on a scale||Standard Deviation|Mean
742965|NCT00488319|Secondary|Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Speed of Processing Domain Test Variable Child Color Trials Test 1 Time: Scaled - Last Observation Carried Forward|A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance.|Baseline, Week 24|The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set.||Scores on a scale||Standard Deviation|Mean
742966|NCT00488319|Secondary|Change From Open Label Baseline to Open Label Endpoint - Cognitive Domain: Speed of Processing Domain Test Variable Trials Part A Time: Scaled - Last Observation Carried Forward|A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance.|Baseline, Week 24|The open label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open label study drug and had both the baseline and at least 1 postbaseline assessment in the open label phase were included in this analysis set.||Scores on a scale||Standard Deviation|Mean
742967|NCT00488319|Secondary|Change From Open Label Baseline to Open Label Endpoint - Cognitive Domain: Social Cognition Domain Test Variable - Theory of Mind-Total - Last Observation Carried Forward|A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance.|Baseline, Week 24|The open label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open label study drug and had both the baseline and at least 1 postbaseline assessment in the open label phase were included in this analysis set.||Scores on a scale||Standard Deviation|Mean
742968|NCT00488319|Secondary|Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Visual Learning and Memory Domain Test Variable, Rey Complex Figure Test - Total, Scaled - Last Observation Carried Forward|A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance.|Baseline, Week 24|The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set.||Scores on a scale||Standard Deviation|Mean
742984|NCT00488345|Primary|Area Under the Curve (AUCτ) From Time Zero to Time of Estimated Concentration at 12 Hours|AUCτ: AUC between doses from time zero to the time of estimated concentration at 12 hours reported in nanograms * hours divided by milliliters (ng*h/mL) was calculated using the log-trapezoidal rule for decreasing concentrations and the linear-trapezoidal rule for increasing concentrations estimating the 12 hour drug concentration if necessary.|Day 3 (just before and immediately after infusion, and 0.75, 2, and 6 hours post-dose)|mITT; N = number of participants with sufficient reported tigecycline concentration data to estimate AUC.||ng*h/mL||Standard Deviation|Mean
755232|NCT00593372|Secondary|Change on Mini-Mental State Examination||End of Study||||||
742969|NCT00488319|Secondary|Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Verbal Learning and Memory Domain Test Variable California Verbal Learning Test-Total Trials, Scaled - Last Observation Carried Forward|A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance.|Baseline, Week 24|The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set.||Scores on a scale||Standard Deviation|Mean
742970|NCT00488319|Secondary|Change From Open-label Baseline to Open-label - Cognitive Domain: Verbal Learning and Memory Domain Test Variable Wide Range Assessment of Memory and Learning Story - Total, Scaled - Last Observation Carried Forward|A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance.|Baseline, Week 24|The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set.||Scores on a scale||Standard Deviation|Mean
742971|NCT00488319|Secondary|Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Attention/Working Memory Domain Test Variable Digit Span, Scaled - Last Observation Carried Forward|A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance.|Baseline, Week 24|The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set.||Scores on a scale||Standard Deviation|Mean
742972|NCT00488319|Secondary|Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Attention/Working Memory Domain Test Variable Coding, Scaled - Last Observation Carried Forward|A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance.|Baseline, Week 24|The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set.||Scores on a scale||Standard Deviation|Mean
742973|NCT00488319|Secondary|Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Motor Speed Domain Test Variable, Finger Tapping Dominant- and Non-Dominant Hand, Scaled - Last Observation Carried Forward|A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance.|Baseline, Week 24|The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set.||Scores on a scale||Standard Deviation|Mean
742974|NCT00488319|Secondary|Change From Open-label Baseline to Open-label Endpoint in the Children’s Global Assessment Scale (CGAS) - Last Observation Carried Forward|The CGAS is a 100 point rating scale which measures the psychological, social, and school functioning for children 6 to 17 years of age. The score ranges from 1 to 100, divided into 10 equal intervals to rate the impairment level of general functioning (poor to superior functioning). Higher scores denote better functioning.|Baseline, Week 104 or the last post-baseline assessment|The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set.||Scores on a scale||Standard Deviation|Mean
742975|NCT00488319|Secondary|Change From Open-label Baseline to Open-label Endpoint in the Clinical Global Impression Severity (CGI-S) Scale - Last Observation Carried Forward|"The CGI-S rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher scores indicate worsening."|Baseline, Week 104 or the last post-baseline assessment|The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set.||Scores on a scale||Full Range|Median
742985|NCT00488345|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax)|Time of peak concentration taken directly from the observed data.|Day 3 (immediately post-dose, 0.75, and 2 hours post-dose)|mITT; N = number of participants with evaluable tigecycline concentration data.||hours||Standard Deviation|Mean
742986|NCT00488345|Primary|Maximum Observed Plasma Concentration (Cmax)|Cmax: tigecycline serum concentration measured in nanograms per milliliter (ng/mL) determined by a validated liquid chromatography with mass spectrophotometric (LC/MS/MS) detection method. Peak concentration was taken directly from the observed data.|Day 3 (immediately post-dose, 0.75, and 2 hours post-dose)|Modified intent to treat (mITT) population: participants who were screened, assigned to study medication and received at least one dose of study medication. N = number of participants with evaluable tigecycline concentration data.||ng/mL||Standard Deviation|Mean
742976|NCT00488319|Secondary|Change From Open-label Baseline to Open-label Endpoint in the Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Based on Marder Factors - Last Observation Carried Forward|Neuropsychiatric symptoms of schizophrenia were assessed using the 30-item PANSS scale. PANSS scale provides a total score (sum of scores of all 30 items) and scores for 3 subscales, ie, positive (7 items), negative (7 items), and general psychopathology (16 items) subscales. Each item is scored on a scale of 1 (absent) to 7 (extreme). Positive Factor Score (range: 8 to 56): sum of select scores from positive, negative, and general psychopathology subscales. Negative Factor Score (range: 7 to 49): sum of select scores from negative and general psychopathology subscales. Disorganized Thoughts Factor Score (range: 7 to 49): sum of select scores from positive, negative, and general psychopathology subscales. Uncontrolled Hostility/Excitement Factor Score (range: 4 to 28): sum of select scores from positive and general psychopathology subscales. Anxiety/Depression Factor Score (range: 4 to 28): sum of select scores from general psychopathology subscale. Higher scores indicate worsening.|Baseline, Week 104 or the last post-baseline assessment|The open label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open label study drug and had both the baseline and at least 1 postbaseline assessment in the open label phase were included in this analysis set.||Scores on a scale||Standard Deviation|Mean
742977|NCT00488319|Secondary|Change From Open-label Baseline to Open-label Endpoint in Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Scores - Last Observation Carried Forward|The PANSS is a medical scale that assesses various symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill).|Baseline, Week 104 or the last post-baseline assessment|The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set.||Scores on a scale||Standard Deviation|Mean
742978|NCT00488319|Primary|The Number of Participants Who Experienced Adverse Events as a Measure of Safety and Tolerability|A serious adverse event as defined by the International Conference on Harmonisation (ICH) is any untoward medical occurrence that at any dose results in death, is life-threatening (the subject was at risk of death at the time of the even; it does not refer to an event that hypothetically might have caused death if it were more severe), requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.|Up to 2 years|The safety analysis set was used for the safety analyses and included all enrolled participants who received at least 1 dose of the open-label study drug as recorded on the electronic case report form. This population was considered as evaluable participants.||Number of Participants|||Number
742979|NCT00488345|Secondary|Population Pharmacokinetic (PK) Model: Effect of Weight|Two compartment model with linear clearance and effect of weight on clearance using pooled PK data from 2 pediatric studies. All concentration-time data were combined and analyzed using population PK methods to investigate potential influence of age, weight, and height (dose, tigecycline concentrations, times, subject weight, height, age, body surface area, serum creatinine, estimated creatinine clearance, serum bilirubin.|3074K4-2207: Day 3 just before and immediately after infusion, and 0.75, 2, and 6 hours post-dose; 3074A1-110: just before and 0.5, 0.75, 1, 2, 3, 4, 8, 12, 24, 36, and 48 hours after start of infusion|Separate population pharmacokinetic analysis results are not available for the current study as more than 1 study was involved in this analysis based on pooled data from pediatric studies 3074A1-110 and 3074K4-2207.|||||
742980|NCT00488345|Secondary|Population Pharmacokinetic (PK) Model: Clearance|Two compartment model with linear clearance and effect of weight on clearance using pooled PK data from 2 pediatric studies. All concentration-time data were combined and analyzed using population PK methods to investigate potential influence of age, weight, and height (dose, tigecycline concentrations, times, subject weight, height, age, body surface area, serum creatinine, estimated creatinine clearance, serum bilirubin.|3074K4-2207: Day 3 just before and immediately after infusion, and 0.75, 2, and 6 hours post-dose; 3074A1-110: just before and 0.5, 0.75, 1, 2, 3, 4, 8, 12, 24, 36, and 48 hours after start of infusion|Separate population pharmacokinetic analysis results are not available for the current study as more than 1 study was involved in this analysis based on pooled data from pediatric studies 3074A1-110 and 3074K4-2207.|||||
742981|NCT00488345|Primary|Percentage of Participants With Clinical Response (CR) to Tigecycline at Last Day of Therapy (LDOT) and Test-of-Cure (TOC) Assessment|CR = Cure: resolution of all signs, symptoms (SS) of infection (INF) or improvement, no further antibacterial therapy (AT) necessary; Improved (IMP): SS IMP to extent that switch to oral AT deemed appropriate; Failure: lack of response, required additional AT, initial recovery then deterioration requiring further AT, death due to the INF after day 2, death due to treatment (TR)-related adverse event (AE), required non-routine surgical TR >48 hours after 1st dose of TR due to failure to IMP or clinical worsening. TOC = CR, vital signs, physical exam, laboratory results, concomitant TR, and AEs.|Day 14 or LDOT, TOC Visit (10 to 21 days after last dose of total antibiotic therapy)|mITT||percentage of participants|||Number
742982|NCT00488345|Secondary|Population Pharmacokinetic (PK) Model: Volume of Distribution|Two compartment model with linear clearance and effect of weight on clearance using pooled PK data from 2 pediatric studies. All concentration-time data were combined and analyzed using population PK methods to investigate potential influence of age, weight, and height (dose, tigecycline concentrations, times, subject weight, height, age, body surface area, serum creatinine, estimated creatinine clearance, serum bilirubin.|3074K4-2207: Day 3 just before and immediately after infusion, and 0.75, 2, and 6 hours post-dose; 3074A1-110: just before and 0.5, 0.75, 1, 2, 3, 4, 8, 12, 24, 36, and 48 hours after start of infusion|Separate population pharmacokinetic analysis results are not available for the current study as more than 1 study was involved in this analysis based on pooled data from pediatric studies 3074A1-110 and 3074K4-2207.|||||
742983|NCT00488345|Primary|Weight Normalized Drug Clearance (CLW)|Weight normalized drug clearance measured in liters per hour per kilogram (L/hr/kg). Drug clearance (CL) was determined as the ratio of dose/area under the concentration-time curve from time zero (start of infusion) to 12 hours (start of next infusion) (AUCτ). CLW was determined as the ratio of CL/weight.|Day 3 (just before and immediately after infusion, and 0.75, 2, and 6 hours post-dose)|mITT; N = number of participants with sufficient reported tigecycline concentration data to estimate AUC.||L/hr/kg||Standard Deviation|Mean
768707|NCT00699400|Secondary|Number of Oocytes Frozen||At cryopreservation|||Number of Oocytes Frozen|Participants||Number
742987|NCT00488475|Other Pre-specified|Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) With or Without Concomitant Methotrexate (MTX) Therapy|Participants with or without concomitant methotrexate (MTX) treatment were reported for AEs or SAEs. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Week 2 up to Week 52|Safety analysis population included all participants with available documentations. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and 'n' signifies participants evaluable for specified category.||participants|||Number
742988|NCT00488475|Other Pre-specified|Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included SAEs as well as non-serious AEs which occurred during the study.|Week 2 up to Week 52|Safety analysis population included all participants with available documentations.||participants|||Number
742989|NCT00488475|Other Pre-specified|Percentage of Participants With Low Disease Activity Determined by Disease Activity Score 28 Based on 28-joints Count (DAS 28)|DAS28 calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and Patient global assessment of disease activity (recorded on a VAS of 0 mm [very good] to 100 mm [very bad]). Total score range: 0 to 10, higher score indicated more disease activity. DAS28 defined low disease activity was classified as a score of <=3.2.|Week 2, 6, 12, 26, 38, 52|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points.||percentage of participants||95% Confidence Interval|Number
742990|NCT00488475|Secondary|Fatigue Visual Analog Scale (VAS)|Participants assessed their fatigue during the last 7 days using a 0 mm - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue.|Baseline, Week 26, 52|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points.||mm||Standard Deviation|Mean
742991|NCT00488475|Secondary|C-Reactive Protein (CRP)|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 2, 6, 12, 26, 38, 52|Safety analysis population included all participants with available documentations. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and 'n' signifies participants evaluable at specified time points.||milligram per deciliter (mg/dL)||Standard Deviation|Mean
742992|NCT00488475|Secondary|Patient Global Assessment of Disease Activity|Patient global assessment of disease activity was measured using a 100 mm Visual Analog Scale (VAS) ranging from 0 mm= very good to 100 mm = very bad.|Baseline, Week 2, 6, 12, 26, 38, 52|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points.||mm||Standard Deviation|Mean
742993|NCT00488475|Secondary|Physician Global Assessment of Disease Activity|Physician global assessment of disease activity was measured on a 0 mm to 100 mm Visual Analog Scale (VAS), with 0 mm = no disease activity and 100mm = maximum possible disease activity.|Baseline, Week 2, 6, 12, 26, 38, 52|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points.||mm||Standard Deviation|Mean
742994|NCT00488475|Secondary|Patient Global Assessment of Arthritis Pain|Participants assessed arthritis pain using a 0 mm - 100 mm Visual Analog Scale (VAS) where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst).|Baseline, Week 2, 6, 12, 26, 38, 52|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points.||mm||Standard Deviation|Mean
742995|NCT00488475|Secondary|Duration of Morning Stiffness|Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If stiffness persisted the entire day, 999 minutes was recorded [largest value possible to document] which may also include values up to 1440 minutes [= complete day]).|Baseline, Week 2, 6, 12, 26, 38, 52|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points.||minutes||Full Range|Median
743013|NCT00488488|Secondary|Antibiotic Agents Chosen for Combination Therapy With Tigecycline|Percentage of participants who received each antibiotic administered as combination therapy with tigecycline.|Baseline to End of Treatment (up to Day 47)|All participants; N = number of participants who were concomitantly treated with other antibiotics in combination with Tygacil; n = number of participants who were concomitantly treated with specified antibiotic in combination with Tygacil.||percentage of participants|||Number
743106|NCT00489255|Secondary|Median Time to 'on' for Visit 3/End of Period 1 Injection|Time to “on” (relief of immobility) was measured 20 minutes after administration of Apokyn and before discharge at the clinic; calculated as the difference between the recorded time of “on” and time of injection.|Day 28|This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population.||minutes||95% Confidence Interval|Median
742996|NCT00488475|Secondary|Percentage of Participants With Response Determined by Disease Activity Score Based on 28-Joints Count (DAS 28)|The DAS28-based European League Against Rheumatism (EULAR) response criteria was used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and level of disease activity reached (final values). Good responders: change from baseline >1.2 with DAS28 final value <=3.2; moderate responders: change from baseline >1.2 with DAS28 final values >3.2 to <=5.1 and >5.1 or change from baseline >0.6 to <=1.2 with DAS28 final values <=3.2 and >3.2 to <=5.1; non-responders: change from baseline <=0.6 with DAS28 final values <=3.2, >3.2 to <=5.1 and >5.1 or change from baseline >0.6 to <=1.2 with DAS28 final values >5.1. Good and moderate responders were considered to have DAS28 response.|Week 2, 6, 12, 26, 38, 52|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points.||percentage of participants||95% Confidence Interval|Number
742997|NCT00488475|Secondary|Percentage of Participants With Remission Determined by Disease Activity Score Based on 28-Joints Count (DAS 28)|DAS28 calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and Patient global assessment of disease activity (recorded on a VAS of 0 mm [very good] to 100 mm [very bad]). Total score range: 0 to 10, higher score indicated more disease activity. DAS28 defined remission was classified as a score of <2.6.|Week 2, 6, 12, 26, 38, 52|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points.||percentage of participants||95% Confidence Interval|Number
742998|NCT00488475|Secondary|Erythrocyte Sedimentation Rate (ESR)|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hour. A higher rate is consistent with inflammation.|Baseline, Week 2, 6, 12, 26, 38, 52|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points.||millimeter per hour (mm/h)||Standard Deviation|Mean
742999|NCT00488475|Secondary|Tender Joints Count (TJC)|Number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.|Baseline, Week 2, 6, 12, 26, 38, 52|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points.||joints||Standard Deviation|Mean
743000|NCT00488475|Secondary|Swollen Joints Count (SJC)|Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1.|Baseline, Week 2, 6, 12, 26, 38, 52|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points.||joints||Standard Deviation|Mean
743001|NCT00488475|Secondary|Disease Activity Score Based on 28-Joints Count (DAS28)|DAS28 calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and Patient global assessment of disease activity (recorded on a VAS of 0 mm [very good] to 100 mm [very bad]). Total score range: 0 to 10, higher score indicated more disease activity. DAS28 less than (<) 2.6 = remission, DAS28 less than or equal to (<=) 3.2 = low disease activity, DAS28 greater than or equal to (>=) 3.2 to <=5.1 = moderate disease activity, DAS28 greater than (>) 5.1 = high disease activity.|Baseline, Week 2, 6, 12, 26, 38, 52|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points.||units on a scale||Standard Deviation|Mean
743002|NCT00488475|Secondary|Duration of Working Disability|"Duration of working disability was assessed as number of days a participant was disable to work. Duration of work disability was considered as 0 if participant was not disable to work during period of assessment. At baseline, participants’ duration of working disability during last 12 months before enrollment into the study was documented. After enrollment, participants’ duration of working disability was documented for last 6 months after previous documentation."|Baseline, Week 26, Week 52|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points.||days||Full Range|Median
743003|NCT00488475|Secondary|Duration of Healthcare Resources Utilization|Participants’ duration of healthcare resources utilization was evaluated as number of days for healthcare resources utilization including: duration of visits to general practitioners, to rheumatologist, to other medical specialists, inpatient hospitalizations, inpatient rehabilitations, inpatient follow-up treatment, outpatient rehabilitations, physiotherapy, and other healthcare utilizations. At baseline, number of days for participants’ healthcare resources utilizations during last 12 months before enrollment into the study were documented. After enrollment, number of days for participants’ healthcare resources utilization were documented for last 6 months after previous documentation.|Baseline, Week 26, Week 52|Effectiveness population. Here 'N' (number of participants analyzed) = overall participants evaluable for any event for this measure and 'n'= participants evaluable for specified event at specified time points.||days||Full Range|Median
743955|NCT00504556|Primary|Adjudicated Incidence of Bleeding Events|Adjudicated Incidence of Bleeding Events during treatment period|3 months|safety analysis set||percent of subjects with outcome event||95% Confidence Interval|Number
743004|NCT00488475|Secondary|Healthcare Resource Utilization|Participants’ utilization of healthcare resources was evaluated as number of events for healthcare resources utilization including: number of visits to general practitioners, visits to rheumatologist, visits to other medical specialists, inpatient hospitalizations, inpatient rehabilitations, inpatient follow-up treatment, outpatient rehabilitations, physiotherapy, and other healthcare utilizations. At baseline, number of events for participants’ healthcare resources utilization during last 12 months before enrollment into the study were documented. After enrollment, number of events for participants’ healthcare resources utilization were documented for last 6 months after previous documentation.|Baseline, Week 26, Week 52|Effectiveness population. Here 'N' (number of participants analyzed) = overall participants evaluable for any event for this measure and 'n'= participants evaluable for specified event at specified time points.||events||Standard Deviation|Mean
743005|NCT00488475|Secondary|Work Productivity and Activity Impairment - Special Health Problems (WPAI:SHP)|WPAI:SHP is 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to rheumatoid arthritis for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.|Baseline, Week 26, Week 52|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points.||percentage of impairment||Standard Deviation|Mean
743006|NCT00488475|Secondary|Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO)|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health state profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain or discomfort, and anxiety or depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol group assigns a utility value for each domain in the profile. EQ-5D score is transformed to EQ-5D-TTO score ranging from -0.205 to 0.999; higher score indicates a better health state.|Baseline, Week 26, Week 52|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points.||units on a scale||Standard Deviation|Mean
743007|NCT00488475|Secondary|Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeter (mm) (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Week 26, Week 52|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points.||mm||Standard Deviation|Mean
743008|NCT00488475|Primary|Percentage of Participants Achieving Functional Remission Determined by Hannover Functional Ability Questionnaire (FFbH) at Week 52|Hannover Functional Ability Questionnaire (FFbH) consists 18 questions to assess daily activities in last 7 days. Each question is answered by the participant as “Yes, I can perform the activity without difficulty” (score assigned = 2), “Yes, but with some difficulties” (score assigned = 1) and “No or only with help” (score assigned = 0). Final FFbH score (FFbH functional capacity) is then computed according to formula: (Sum of all single scores * 100%) / (2 * number of answered questions), ranging between 0-100; higher score indicates better daily activities. FFbH functional remission is defined as FFbH functional capacity of >= 83%.|Week 52|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of rheumatoid arthritis, who had not received treatment with etanercept previously and who had post baseline documentations. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||percentage of participants||95% Confidence Interval|Number
743009|NCT00488475|Primary|Percentage of Participants Achieving Functional Remission Determined by Hannover Functional Ability Questionnaire (FFbH) at Week 26|Hannover Functional Ability Questionnaire (FFbH) consists 18 questions to assess daily activities in last 7 days. Each question is answered by the participant as “Yes, I can perform the activity without difficulty” (score assigned = 2), “Yes, but with some difficulties” (score assigned = 1) and “No or only with help” (score assigned = 0). Final FFbH score (FFbH functional capacity) is then computed according to formula: (Sum of all single scores * 100% [percent]) / (2 * number of answered questions) ranging between 0-100; higher score indicates better daily activities. FFbH functional remission is defined as FFbH functional capacity of >= 83%.|Week 26|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of rheumatoid arthritis, who had not received treatment with etanercept previously and who had post baseline documentations. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||percentage of participants||95% Confidence Interval|Number
743010|NCT00488488|Secondary|Overall Mortality: All Participants|Deaths for any reasons occurring during the study observation period.|Baseline to End of Treatment (up to Day 47)|All participants. Overall mortality was not calculated separately for nosocomial and community-acquired infections.||percentage of participants||95% Confidence Interval|Number
743011|NCT00488488|Secondary|Reasons for Utilization of Tygacil||Baseline to End of Treatment (up to Day 47)|All participants; n = number of participants with specified reason for utilization of Tygacil.||percentage of participants|||Number
743012|NCT00488488|Secondary|Change of Antibiotic Treatment From Tygacil to Alternative Antibiotic|Reasons for change in antibiotic treatment from Tygacil to another antibiotic.|Baseline to End of Treatment (up to Day 47)|All participants; N = number of participants with a documented therapy switch in antibiotic treatment from Tygacil to another antibiotic; n = number of participants with specified reason for switch in antibiotic treatment . Multiple specifications were possible.||percentage of participants|||Number
743014|NCT00488488|Secondary|Percentage of Participants With Resistant Pathogens Identified at Follow-up Due to Treatment Failure|Percentage of participants with resistant pathogens for each pathogen identified at second (follow-up) microbial examination. A second microbiological examination was documented only for participants with treatment failure. Treatment failure = no significant improvement of infection symptoms under Tygacil therapy.|Follow-up (up to Day 47)|All participants; N = number of participants who had a follow-up microbial investigation due to treatment failure; n = number of participants who tested positive for pathogen and had isolates tested for pathogen resistance.||percentage of participants|||Number
743015|NCT00488488|Secondary|Participants With Probable Failure at Follow-up|Participants with antibiogram follow-up due to treatment failure who had detectable pathogens. Treatment failure = no significant improvement of infection symptoms under Tygacil therapy.|Follow-up (up to Day 47)|All participants.||participants|||Number
743016|NCT00488488|Primary|Percentage of Participants With Composite Cure: Community-acquired Infections|Composite Cure = complete resolution or improvement of infection symptoms; no further antibiotic treatment required.|End of Treatment (duration based on severity, location, and clinical response: maximum duration 47 days)|All participants; N = number participants with community-acquired infections.||percentage of participants|||Number
743017|NCT00488488|Primary|Percentage of Participants With Composite Cure: Nosocomial Infections|Composite Cure = complete resolution or improvement of infection symptoms; no further antibiotic treatment required.|End of Treatment (duration based on severity, location, and clinical response; maximum duration 47 days)|All participants; N = number of participants with nosocomial infections.||percentage of participants|||Number
743018|NCT00488488|Primary|Percentage of Participants With Composite Cure: All Participants|Composite Cure = complete resolution or improvement of infection symptoms; no further antibiotic treatment required.|End of Treatment (duration based on severity, location, and clinical response; maximum duration 47 days)|All participants.||percentage of participants|||Number
743019|NCT00488488|Primary|Percentage of Participants With Clinical and Microbiological Cure: Community-acquired Infections|Cure = complete resolution of infection symptoms; no further antibiotic treatment required. A second microbiological examination was documented only for participants with treatment failure.|End of Treatment (duration based on severity, location, and clinical response: maximum duration 47 days)|All participants; N = number of participants with community-acquired infections.||percentage of participants||95% Confidence Interval|Number
743020|NCT00488488|Primary|Percentage of Participants With Clinical and Microbiological Cure: Nosocomial Infections|Cure = complete resolution of infection symptoms; no further antibiotic treatment required. A second microbiological examination was documented only for participants with treatment failure.|End of Treatment (duration based on severity, location, and clinical response; maximum duration 47 days)|All participants; N = number of participants with nosocomial infections.||percentage of participants||95% Confidence Interval|Number
743021|NCT00488488|Primary|Percentage of Participants With Clinical and Microbiological Cure: All Participants|Cure = complete resolution of infection symptoms; no further antibiotic treatment required. A second microbiological examination was documented only for participants with treatment failure.|End of Treatment (duration based on severity, location, and clinical response; maximum duration 47 days)|All participants: participants exposed to Tygacil who had non-retrospective post-baseline data.||percentage of participants||95% Confidence Interval|Number
743022|NCT00488514|Secondary|Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire–Revised (PPMQ-R) at Month 12|The PPMQ-R is a fully validated 32-item questionnaire assessing participant satisfaction with acute migraine medication and includes 3 questions that assess satisfaction with respect to efficacy, side effects, and overall satisfaction (i.e., How effective the medication is overall, side effects of the medication, overall satisfaction with the medication). Each item is rated on a 7-point scale ranging from “very satisfied” (1) to “very dissatisfied” (7).|End of Study/Month 12|Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet. Due to data collection and/or assignment of a collected assessment to a visit, the number of participants analyzed at a given visit could vary.||participants|||Number
743023|NCT00488514|Secondary|Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire–Revised (PPMQ-R) at the Screening Visit|The PPMQ-R is a fully validated 32-item questionnaire assessing participant satisfaction with acute migraine medication and includes 3 questions that assess satisfaction with respect to efficacy, side effects, and overall satisfaction (i.e., How effective the medication is overall, side effects of the medication, overall satisfaction with the medication). Each item is rated on a 7-point scale ranging from “very satisfied” (1) to “very dissatisfied” (7).|Screening|Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet. Due to data collection and/or assignment of a collected assessment to a visit, the number of participants analyzed at a given visit could vary.||participants|||Number
743024|NCT00488514|Secondary|Mean Change From Baseline in the Migraine Specific Quality of Life (QOL) Questionnaire for Adolescents (MSQ-A) Score at Months 3, 6, 9, and 12|The MSQ-A consists of 14 items measuring how migraines affect QOL: Role Function (RF)-Restrictive (items 1-7) and RF-Preventative (items 8-11), examining the degree to which performance of daily activities is limited or interrupted, respectively, by migraine; RF-Emotional (items 12-14, examining frustration/helplessness due to migraine). Dimensions (dim.) are scored independently. The 14 items are reverse coded onto a 1-6 scale; dim. are then created by summing specific item scores and transforming raw total score onto a 0-100 scale. For each dim., higher scores indicate better health status.|Baseline and Months 3, 6, 9, and 12|Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet. Due to data collection and/or assignment of a collected assessment to a visit, the number of participants analyzed at a given visit could vary.||points on a scale||Standard Error|Mean
743107|NCT00489255|Secondary|Median Time to 'on' for Visit 2/Period 1 Injection 2|Time to “on” (relief of immobility) was measured 20 minutes after administration of Apokyn and before discharge at the clinic; calculated as the difference between the recorded time of “on” and time of injection.|Day 1 (Visit 2)|This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population.||minutes||95% Confidence Interval|Median
743025|NCT00488514|Secondary|Number of Treated Migraine Attacks With Photophobia, Phonophobia, Nausea, Neck Pain, Sinus Pain, and Vomiting|The number of treated migraine attacks with the reported migraine-associated symptoms of photophobia, phonophobia, nausea, neck pain, sinus pain, and vomiting were counted. Photophobia: sensitivity to light; phonophobia: sensitivity to sound.|Baseline through End of Study (up to Month 12)|Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet||treated migraine attacks|||Number
743026|NCT00488514|Secondary|Number of Migraine Attacks Rated With the Indicated Pain Severity|The number of migraine attacks treated at the mild, moderate, or severe intensity were counted. Pain severity was assessed by participants based on a scale of 0-3: 0=no pain, 1=mild, 2= moderate, 3=severe.|Baseline through End of Study (up to Month 12)|Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet||treated migraine attacks|||Number
743027|NCT00488514|Secondary|Number of Total Migraines Headaches and Migraines Treated With the Combination Tablet|The total number of migraine headaches and the number of migraine headaches treated with the Combination Tablet during the study were summarized.|Baseline through End of Study (up to Month 12)|Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet||migraine attacks|||Number
743028|NCT00488514|Secondary|Average Number of Headaches, Migraine Attacks, and Treated Migraine Attacks Per Month|The average number of headaches (non-migraine and migraine attacks), migraine attacks, and treated migraine attacks per month was calculated for each participant, based on their time in the study. The outcome measure represents the average of the mean number of the headaches, migraine headaches, and treated migraines per month of the study participants in the 6 Month, 12 Month, and ITT Populations. A treated attack is defined as a migraine treated with the Combination Tablet.|Baseline through End of Study (up to Month 12)|Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet||events||Standard Deviation|Mean
743029|NCT00488514|Secondary|Number of Treated Attacks Classified as Migraine Pain-Free Within 4 Hours That Were Also Pain Free Within 2 Hours of Dosing With the Combination Tablet|The number of migraine attacks eligible for evaluation, not associated with rescue medication use, and not associated with either rescue medication use or prohibited medications were counted. Migraine Pain Free was defined as the migraine attack ending <= 4 hours after the participant was dosed with the Combination Tablet.|Baseline through End of Study (up to Month 12)|ITT Population: all participants who took at least one dose of study drug and had at least one post-treatment migraine assessment||treated migraine attacks|||Number
743030|NCT00488514|Secondary|Number of Treated Attacks Classified as Migraine Pain-Free (MPF) Within 4 Hours of Dosing With a Combination Tablet|The number of migraine attacks eligible for evaluation, not associated with rescue medication use, and not associated with either rescue medication use or prohibited medications were counted. Migraine Pain Free was defined as the migraine attack ending <= 4 hours after the participant was dosed with the Combination Tablet.|Baseline through End of Study (up to Month 12)|ITT Population: all participants who took at least one dose of study drug and had at least one post-treatment migraine assessment||treated migraine attacks|||Number
743031|NCT00488514|Secondary|Number of Treated Attacks Classified as Migraine Pain-Free (MPF) Within 24 Hours of Dosing With the Combination Tablet|The number of migraine attacks eligible for evaluation, not associated with rescue medication use, and not associated with either rescue medication use or prohibited medications were counted. Migraine Pain Free was defined as the migraine attack ending <= 24 hours after the participant was dosed with the Combination Tablet.|Baseline through End of Study (up to Month 12)|ITT Population: all participants who took at least one dose of study drug and had at least one post-treatment migraine assessment||treated migraine attacks|||Number
743032|NCT00488514|Secondary|Number of Treated Migraine Attacks|The number of migraine attacks eligible for evaluation, not associated with rescue medication use, or prohibited medications, was summarized. Rescue medication was additional medication taken within 24 hours of Combination Tablet. Prohibited medications: ergot, opioid, barbiturate, 5-HT1 agonist, long-acting non-steroidal anti-inflammatory drug (NSAID), short-acting NSAID-containing compound, analgesic, anti-emetic, monoamine oxidase inhibitors, St. John’s Wort, angiotensin-converting enzyme inhibitor, Angiotensin II receptor blockers, anti-coagulant, anti-platelet.|Baseline through End of Study (up to Month 12)|Intent-to-Treat (ITT) Population: all participants who took at least one dose of study drug and had at least one post-treatment migraine assessment||treated migraine attacks|||Number
743033|NCT00488514|Secondary|Number of Participants With Abnormal Electrocardiogram Findings at Screening and at the Final Visit as Assessed by the Investigator|The number of participants with an electrocardiogram (ECG) status of normal, abnormal, clinically significant (CS), or not clinically significant (NCS), as determined by the Investigator, was reported. Specific definitions of ECG categorizations were not provided; investigators were expected to apply reasonable standards of clinical judgment. Normal, all ECG parameters within accepted normal ranges; abnormal, ECG finding(s) outside of normal ranges; CS, ECG with a CS abnormality that meets exclusion criteria; NCS, ECG with an abnormality not CS or meeting exclusion criteria per investigator.|Screening and Final Visit (up to Month 12)|Safety Population: all participants in the Enrolled Population who took at least one dose of the combination tablet. The number of participants with an assessment may vary, depending on the number of assessments completed at each visit.||participants|||Number
743034|NCT00488514|Secondary|Mean Heart Rate for All Study Participants at the Indicated Time Points|A sitting heart rate was measured once for each participant at each visit.|Screening and Months 3, 6, 9, and 12|Safety Population: all participants in the Enrolled Population who took at least one dose of the combination tablet. The number of participants with an assessment may vary, depending on the number of assessments completed at each visit.||beats per minute||Standard Deviation|Mean
743047|NCT00488514|Secondary|Number of Participants With Any Adverse Event Categorized by Severity|The number of participants with at least one mild (an event that is easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities), moderate (an event that is sufficiently discomforting to interfere with normal everyday activities), or severe adverse event (an event that prevents normal everyday activities) was recorded.|Baseline through End of Study (up to Month 12)|Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet||participants|||Number
743035|NCT00488514|Secondary|Mean Blood Pressure for All Study Participants at the Indicated Time Points|At each visit, a participant’s blood pressure was taken three times. The average of the three readings was then calculated for each participant at each visit (mean blood pressure). The outcome measure represents the average of the mean blood pressure of all of the study participants. SBP, systolic blood pressure; DBP, diastolic blood pressure.|Screening and Months 3, 6, 9, and 12|Safety Population: all participants in the Enrolled Population who took at least one dose of the combination tablet. The number of participants with an assessment may vary, depending on the number of assessments completed at each visit.||millimeters of mercury (mmHg)||Standard Deviation|Mean
743036|NCT00488514|Secondary|Mean Body Mass Index (BMI) for All Study Participants at the Indicated Time Points|BMI = (Weight in kilograms)/(height in centimeters/100)^2|Screening and Months 3, 6, 9, and 12|Safety Population: all participants in the Enrolled Population who took at least one dose of the combination tablet. The number of participants with an assessment may vary, depending on the number of assessments completed at each visit.||kilograms per meters squared||Standard Deviation|Mean
743037|NCT00488514|Secondary|Mean Weight for All Study Participants at the Indicated Time Points||Screening and Months 3, 6, 9, and 12|Safety Population: all participants in the Enrolled Population who took at least one dose of the combination tablet. The number of participants with an assessment may vary, depending on the number of assessments completed at each visit.||kilograms||Standard Deviation|Mean
743038|NCT00488514|Secondary|Mean Height for All Study Participants at the Indicated Time Points||Screening and Months 3, 6, 9, and 12|Safety Population: all participants in the Enrolled Population who took at least one dose of the combination tablet. The number of participants with an assessment may vary by visit, depending on the number of assessments completed at each visit.||centimeters||Standard Deviation|Mean
743039|NCT00488514|Secondary|Number of Participants With Hematocrit and Hemoglobin Values of Interest That Shifted From Normal at Baseline to Abnormal at the End of Study Visit|A shift from “normal to low,” for example, indicates that a value was normal at baseline but low at the end of study visit. The value ranges were determined by the central laboratory. Reference ranges: hemoglobin, 12-17 years old (y): 120-160 grams (g)/L; hematocrit (expressed as the percentage of blood occupied by red blood cells), 12-17 y: 0.360-0.490.|Baseline through End of Study (up to Month 12)|Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet. The number of participants with an assessment may vary, depending on the number of assessments completed at each visit.||participants|||Number
743040|NCT00488514|Secondary|Number of Participants With Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatinine, Potassium, and Blood Urea Nitrogen (BUN) Values of Interest That Shifted From Normal at Baseline to Abnormal at the End of Study Visit|A shift from “normal to low,” for example, indicates that a value was normal at baseline but low at the end of study visit. The value ranges were determined by the central laboratory. Reference ranges: ALT, 12 years old (y): 0-45 Units/liter (U/L), >13 y: 0-48 U/L; AST, 12 y: 0-42 U/L, >13 y 0-42 U/L; creatinine, 12 y: 27-88 micromoles/liter (UMOL/L), >13 y: 44-124 UMOL/L; potassium, 12 y: 3.5-5.5 millimoles/liter (MMOL/L), >13 y: 3.5-5.3 MMOL/L; BUN, 12-17 y: 24-101 milligrams (mg)/deciliter (dL).|Baseline through End of Study (up to Month 12)|Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet. The number of participants with an assessment may vary, depending on the number of assessments completed at each visit.||participants|||Number
743041|NCT00488514|Secondary|Number of Tablets Taken, After Which at Least One Adverse Event Occurred Within 3 or 5 Days of Dosing With That Combination Tablet|The number of events that occurred within 3 or 5 days of dosing with the combination tablet on a per tablet basis. A total of 8413, 5876, and 9989 tablets were taken by the 6 Month Completer, 12 Month Completer, and the Safety Populations, respectively.|Baseline through End of Study (up to Month 12)|Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet||tablets|||Number
743042|NCT00488514|Secondary|Number of Participants With Any Adverse Event That Occurred Within 3 or 5 Days of the First Dose of the Combination Tablet|The number of participants with adverse events that occurred within 3 or 5 days of their first dose of the Combination Tablet was recorded.|Baseline through End of Study (up to Month 12)|Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet||participants|||Number
743043|NCT00488514|Secondary|Number of Participants With Any Adverse Event Categorized by Participant Gender|The number of participants with adverse events by gender is recorded.|Baseline through End of Study (up to Month 12)|Safety Population: all participants in the Enrolled Population who took at least one dose of the combination tablet||participants|||Number
743044|NCT00488514|Secondary|Number of Participants With Any Adverse Event Categorized by Participant Race|"The number of participants with any adverse event was categorized by race. The category Other captures : American Indian or Alaskan Native; Asian, Native Hawaiian, or Other Pacific Islander; African American/African Heritage and Asian; African American/African Heritage and White; and American Indian or Alaskan Native and White."|Baseline through End of Study (up to Month 12)|Safety Population: all participants in the Enrolled Population who took at least one dose of the combination tablet||participants|||Number
743045|NCT00488514|Secondary|Number of Participants With Any Adverse Event Categorized by Participant Age|The number of participants with any adverse event by age group (12-14 and 15-17 years) is recorded.|Baseline through End of Study (up to Month 12)|Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet||participants|||Number
743046|NCT00488514|Secondary|Number of Participants With Any Adverse Event Categorized Over Time|The number of participants with an adverse event occurring in either the first six months of the study (months 0-6; <=194 days) or the second six months of the study (months 6-12; =>194 days until end of study) was recorded.|Baseline through End of Study (up to Month 12)|Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet||participants|||Number
743276|NCT00496470|Secondary|Serum Tumor Necrosis Factor-alpha (TNF-alpha)|Ratio of treatment period mean to run-in value|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Ratio||Inter-Quartile Range|Median
743050|NCT00488592|Primary|Efficacy in Inducing or Boosting a Cellular Immune Response|A T-cell response was considered positive if the frequencies of interferon (IFN-γ+) cluster of differentiation (CD8+) T cells in peptide-stimulated peripheral bloody mono-nucleated cells (PBMCs) were 2-fold or more higher than the frequencies of interferon (IFN-γ+) CD8+ T cells in unstimulated PBMCs and if there was a minimum of 0.05% Interferon (IFNγ+) CD8+ T cells (after subtracting the frequencies of interferon (IFNγ+) CD8+ T cells in unstimulated PBMCs). A significant vaccine-induced CD8+ T-cell response was defined as the emergence of detectable PR1 or WT1-specific CD8+ T cells when the pre-study analysis found no response, or a 2-fold increase in frequencies when responses were present before vaccination.|16 weeks|||participants|||Number
743051|NCT00488618|Secondary|Change From Baseline in Clinical Global Impression-Severity (CGI-S) Total Score at Week 3|The CGI-S measures the investigator’s assessment of overall severity of the participant’s illness compared with the severity of illness in other patients the physician has observed using a 7-point scale (1=Normal, not ill at all to 7=Among the most extremely ill participants). A negative change from Baseline indicates improvement. Analyses are based on ANCOVA model for change from Baseline with treatment group and study center as factors and Baseline CGI-S score as covariate.|Baseline, 3 Weeks|Intent-to-treat Population included all participants who received at least 1 dose of study drug and who had at least 1 post-baseline YMRS assessment, LOCF.||score on a scale||Standard Error|Least Squares Mean
743052|NCT00488618|Primary|Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Week 3|The YMRS is an 11-item scale that assesses manic symptoms based on the participant’s perception of his or her condition over the previous 48 hours, as well as the physician’s clinical observations during the interview. The 11-items are elevated mood, increased motor activity-energy, sexual interest, sleep, irritability, rate and amount of speech, language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight. The severity of the abnormality for 7-items are rated on a five-point scale (0-4) and 4-items on a nine-point scale (0-8). The individual scores are summed for a total possible score of 0 (best) to 60 (worst). A negative change from Baseline indicates improvement. Analyses are based on an Analysis of Covariance (ANCOVA) model for change from Baseline with treatment group and study center as factors and Baseline value as covariate.|Baseline, Week 3|Intent-to-treat Population included Participants who received at least 1 dose of study drug and who had at least 1 post-baseline YMRS assessment, last observation carried forward (LOCF).||score on a scale||Standard Error|Least Squares Mean
743053|NCT00488631|Secondary|Number of Participants With Clinical Remission at Week 54 and Not Receiving Concomitant Corticosteroids Among Participants on Corticosteroids at Week 0 of Maintenance Study|Clinical remission is defined as a Mayo score of less than or equal to 2, with no individual sub-score greater than 1. The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and physician’s global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12.|Week 54|Analysis population included randomly assigned participants in clinical response to golimumab induction who were receiving concomitant corticosteroids at Week 0 of the study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||Participants|||Number
743054|NCT00488631|Secondary|Number of Participants With Clinical Remission at Both Week 30 and 54 Among Participants With Clinical Remission at Week 0 of Maintenance Study|Clinical remission is defined as a Mayo score of less than or equal to 2, with no individual sub-score greater than 1. The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and physician’s global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12. The number of participants in clinical remission at both the weeks that is Week 30 as well as Week 54 will be reported.|Week 30 and Week 54|Analysis population included randomly assigned participants who were in clinical remission to golimumab induction at Week 0 of the maintenance study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||Participants|||Number
743055|NCT00488631|Secondary|Number of Participants With Mucosal Healing at Both Week 30 and Week 54|Mucosal healing is determined from the endoscopy sub-score of the Mayo score. Mucosal healing is defined as an endoscopy sub-score of 0 or 1. Higher score indicates higher severity of disease. Endoscopy sub-score ranges from 0 (normal or inactive disease) to 3 (severe disease; spontaneous bleeding and ulceration). The number of participants with mucosal healing at both the weeks that is Week 30 as well as Week 54 will be reported.|Week 30 and Week 54|Primary analysis population included randomly assigned participants in clinical response to golimumab induction at Week 0 of the study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||Participants|||Number
743056|NCT00488631|Secondary|Number of Participants With Clinical Remission at Both Week 30 and Week 54|Clinical remission is defined as a Mayo score of less than or equal to 2, with no individual sub-score greater than 1. The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and physician’s global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12. The number of participants in clinical remission at both the weeks that is Week 30 as well as Week 54 will be reported.|Week 30 and Week 54|Primary analysis population included randomly assigned participants in clinical response to golimumab induction at Week 0 of the maintenance study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||Participants|||Number
743057|NCT00488631|Primary|Number of Participants in Clinical Response Through Week 54|Clinical response is defined as decrease from induction baseline in Mayo score by greater than or equal to (>=) 30 percent and >= 3, with either decrease from induction baseline in rectal bleeding subscore of >= 1 or rectal bleeding subscore of 0 or 1. Participants who lost clinical response prior to Week 54 were considered not to meet endpoint. Mayo score is sum of 4 subscores (ie, stool frequency, rectal bleeding, endoscopic findings, physician’s global assessment); each rated on scale from 0 to 3, with higher scores indicating more severe disease. Total Mayo score value ranges from 0 to 12.|Induction Baseline, Week 0 through Week 54|Primary analysis population included randomly assigned participants in clinical response to golimumab induction at Week 0 of the maintenance study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||Participants|||Number
744996|NCT00511667|Secondary|Apparent Terminal Elimination Half-life (T1/2) of MK-0941 After Multiple Doses of MK0941||Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day)|||hours||Standard Deviation|Mean
743058|NCT00488644|Primary|Number of Participants Demonstrating Improvement With Impaired Neuro-cognitive Function (NCF) Based on Results of a Series Neuro-cognitive Exams Administered at Baseline and 8 Weeks After Liothyronine Therapy|At baseline, each participant's scores for standardized/widely-used NCF exams are recorded (recalled words/objects/sequence repetition/etc per tests listed below). After 8 weeks liothyronine therapy, participants are tested again and scores compared to baseline scores. If the participant recalls more numbers/objects/sequence repetition faster/etc., than previous scores, this constitutes an improvement in NCF function for that individual. Scores are not compared to other participants. NCF tests: Memory by RAVLT (Rey Auditory Verbal Learning Test), scored by the number of words correctly recalled at different timepoints; Attention by Digit Span Exam (accurately repeating a sequence of numbers just spoken); Processing speed by Digit Symbol Exam (accurately matching numbers with associated symbols) Executive function by Trail Making Tests and Controlled Oral Word Association; Motor dexterity evaluated by correctly placing pegs in pegboards in a specified time.|At baseline and after 8 weeks of treatment|||participants|||Number
744655|NCT00503113|Secondary|Relative Change From Baseline in Actual GFR (Using CG Formula)|Change (mL/min) from baseline in actual GFR (CG formula using the patient's actual body surface area) after 9 months (or 40 weeks) of treatment.|Baseline and 9 months|PP Population||mL/min||Standard Deviation|Mean
743277|NCT00496470|Secondary|Serum Soluble Tumor Necrosis Factor-alpha (sTNF-alpha)|Ratio of treatment period mean to run-in value|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Ratio||Inter-Quartile Range|Median
743081|NCT00488826|Secondary|Concentration of Serotype-Specific IgG Antibodies|Vaccine efficacy can be assessed by measuring the levels of antibodies to the specific types (or serotypes) of bacteria covered by the vaccine. IgG antibodies for the 7 pneumococcal serotypes in 7vPnC (4, 6B, 9V, 14, 18C, 19F, 23F) were assessed 30-50 days after the third dose of vaccine. Antibody levels were measured by standardized enzyme-linked immunosorbent assay (ELISA). The minimum level of antibodies required to confer protection has been defined as 0.15 ug/ml by the Northern California Kaiser Permanente (NCKP) study and as 0.35 ug/ml by the World Health Organization (WHO).|7 months|"The population analyzed was all the available immunogenicity population (all subjects who completed the primary series of 7vPnC or DTaP and had the post third dose serum available for assessment) and were in either 7vPnC+DTaP Concurrently or DTaP Alone group. The 7vPnC Separately group was not included as part of this objective."||ug/ml||95% Confidence Interval|Geometric Mean
743082|NCT00488826|Primary|Concentration of Serotype-Specific IgG Antibodies|Vaccine efficacy can be assessed by measuring the levels of antibodies to the specific types (or serotypes) of bacteria covered by the vaccine. IgG antibodies for the 7 pneumococcal serotypes in 7vPnC (4, 6B, 9V, 14, 18C, 19F, 23F) were assessed 30-50 days after the third dose of vaccine. Antibody levels were measured by standardized enzyme-linked immunosorbent assay (ELISA). The minimum level of antibodies required to confer protection has been defined as 0.15 ug/ml by the Northern California Kaiser Permanente (NCKP) study, and as 0.35 ug/ml by the World Health Organization (WHO).|7 months|"Population analyzed was available immunogenicity population (all subjects who completed the primary series of 7vPnC or DTaP and had the post-third dose serum available for assessment) and were in either the 7vPnC separately or DTaP alone group. The 7vPnC + DTaP group was not part of the primary objective; no statistical testing was done."||ug/ml||95% Confidence Interval|Geometric Mean
743083|NCT00488865|Primary|Percentage of Participants With Retrieval Clinical Success|Intact filter retrieval via percutaneous techniques from the vasculature without associated injury or damage to the vena cava requiring intervention.|upto 175 days|The population for Option filter retrieval was based on intention to treat (ITT). Retrieval procedures were attempted in 39 of the 100 enrolled patients.||Percent of Participants||95% Confidence Interval|Number
743084|NCT00488865|Secondary|Placement Technical Success|Successful deployment of the filter at the intended placement level such that the filter is judged suitable by the Investigator for mechanical protection against pulmonary embolism.|Immediately post placement procedure|||Percent of Participants||95% Confidence Interval|Number
743085|NCT00488865|Primary|Percentage of Participants With Clinical Success|Placement Technical Success without subsequent pulmonary embolism, significant filter migration, symptomatic caval thrombosis or other complication requiring filter removal or invasive intervention to address condition.|up to 180 days|The number of participants was determined per intention to treat (ITT).||Percent of Participants||95% Confidence Interval|Number
743086|NCT00489086|Secondary|Overall Response at Treated Lesions||36 months||||||
743087|NCT00489086|Secondary|Estimated Duration of Complete Response||36 months||||||
743088|NCT00489086|Secondary|Time to Progression||36 months||||||
743089|NCT00489086|Secondary|Time to Lesion Clearance||36 months||||||
743090|NCT00489086|Primary|Complete Response Rate|The primary endpoint used to evaluate tazarotene efficacy for BCC chemotherapy was the complete response (CR) rate, defined as the complete visible disappearance of a patient’s “target” lesion during the the 18 months of tazarotene application and its failure to recur during the ensuing 18-months. We defined surgical removal of a target lesion as a treatment failure. The primary endpoint was assessed based on intention to treat analysis such that any subject who underwent the baseline evaluation and applied at least 1 dose of tazarotene was included in the analysis. Drop-outs were considered non-responders. A priori treatment success for tazarotene was defined as a CR rate of at least 50%, and treatment failure was defined as a CR rate of 25% or less.|36 months|Intention to treat||participants|||Number
747164|NCT00527878|Secondary|New Skin Infections|Patients reported the number of new skin infections|12 months placebo/12 months ranitidine|Patients that completed the study||skin infections||Full Range|Median
743093|NCT00489216|Secondary|Overall Complete Response Rate|To assess the overall complete response rate on study days 29 and 57 after 4 and 8 doses of weekly subcutaneous efalizumab. A complete response (CR) was defined as the total resolution of skin disease, and a partial response was defined as >=50% reduction in the proportion of total body surface area involved by rash.|57 days|Of the two patients, one patient completed all 8 doses of study medication according to schedule. The other patient received 6/8 scheduled efalizumab doses, but was subsequently taken off the study after developing transient coagulase negative staphylococcal bacteremia. The patient demonstrated a complete response (CR).||Participants|||Count of Participants
743094|NCT00489216|Primary|Exploratory Assessment of the Staining of Cutaneous Tissues for LFA-1, ICAM-1, CD4, CD8, and Possibly CD20|Numerical scoring system for both LFA-1 and ICAM-1 expression which could then be used in a larger phase II trial to correlate clinical response rates to pathological findings.|57 days|There is no data for this outcome measure because of the small number of patients and inability to make meaningful conclusions|||||
743095|NCT00489216|Primary|Degree of Skin Involvement by GVHD Using Two Digital Photography Techniques.|"Estimate of the percentage of body surface area involved by GVHD using two digital photography techniques and computerized image analyses:
Digital photography and body surface area calculations: A total of 12 digital photographs were obtained from different body regions using systematic digital imaging and computerized image analysis.
Body surface area calculations: Using National Institutes of Health image software, each body region will be manually traced and the total area of the traced area determined. Using a similar technique, each part of the region that is involved by a GVHD rash will also be traced and its area measured. The areas involved by rash will then be summed, and finally divided by the total area of the region. In so doing, the percentage of each region that is involved by GVHD will be determined."|120 days|Data was not collected for this objective due to limited number of participants. A minimum of 12 patients were needed for analysis.|||||
743096|NCT00489216|Primary|Number of Subjects Experiencing Adverse Events|"The primary objective of this exploratory study is to evaluate the general tolerability of efalizumab in patients suffering from steroid refractory GVHD
Subjects will be evaluated for drug toxicity each visit. Toxicity will be graded using the Common Terminology Criteria for Adverse Events (CTCAE) common criteria."|120 days|Of the two patients, one patient completed all 8 doses of study medication according to schedule. The other patient received 6/8 scheduled efalizumab doses, but was subsequently taken off the study after developing transient coagulase negative staphylococcal bacteremia.||participants|||Number
743097|NCT00489255|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 5, Post Apokyn Dose, Period 3|Part 3 (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability.|Day 56 (Visit 4)|This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population.||score on a scale||Standard Deviation|Mean
743098|NCT00489255|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 5, Pre Apokyn Dose, Period 3|Part 3 (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability.|Day 84 (Visit 5)|This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population.||score on a scale||Standard Deviation|Mean
743099|NCT00489255|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 4, Post Apokyn Dose, Period 2|Part 3 (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability.|Day 56 (Visit 4)|This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population.||score on a scale||Standard Deviation|Mean
743100|NCT00489255|Secondary|Unified Parkinson’s Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 4, Pre Apokyn Dose, Period 2|Part 3 (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability.|Day 56 (Visit 4)|This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population.||score on a scale||Standard Deviation|Mean
743101|NCT00489255|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 3, Post Apokyn Dose, Period 1|Part 3 (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability.|Day 28|This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population.||score on a scale||Standard Deviation|Mean
743102|NCT00489255|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 3, Pre Apokyn Dose, Period 1|Part 3 (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability.|Day 28|This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population.||score on a scale||Standard Deviation|Mean
743103|NCT00489255|Secondary|Unified Parkinson’s Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 2, Pre Apokyn Dose, Period 1|Part 3 (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability.|Day 1 (Visit 2)|This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population.||score on a scale||Standard Deviation|Mean
743104|NCT00489255|Secondary|Median Time to 'on' for Visit 5/End of Period 3 Injection|Time to “on” (relief of immobility) was measured 20 minutes after administration of Apokyn and before discharge at the clinic; calculated as the difference between the recorded time of “on” and time of injection.|Day 84 (Visit 5)|||minutes||95% Confidence Interval|Median
743108|NCT00489255|Secondary|Median Time to 'on' for Visit 2/Period 1 Injection 1|Time to “on” (relief of immobility) was measured 20 minutes after administration of Apokyn and before discharge at the clinic; calculated as the difference between the recorded time of “on” and time of injection.|Day 1 (Visit 2)|This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population.||minutes||95% Confidence Interval|Median
743109|NCT00489255|Secondary|Subject Global Evaluation of Randomized Study Medication for Period 3|The subject global evaluation of Tigan/placebo was completed by the subject at the visits in response to the question “Overall, how would you rate the study medication you received for nausea/vomiting?” Response choices were excellent, very good, good, fair, or poor.|Day 84 (Visit 5)|This secondary efficacy analysis was performed on the total number of subjects who responded to the evaluation within the Intention-to-Treat (ITT) population.||participants|||Number
743110|NCT00489255|Secondary|Subject Global Evaluation of Randomized Study Medication for Period 2|The subject global evaluation of Tigan/placebo was completed by the subject at the visits in response to the question “Overall, how would you rate the study medication you received for nausea/vomiting?” Response choices were excellent, very good, good, fair, or poor.|Day 56 (Visit 4)|This secondary efficacy analysis was performed on the total number of subjects who responded to the evaluation within the Intention-to-Treat (ITT) population.||participants|||Number
743111|NCT00489255|Secondary|Subject Global Evaluation of Randomized Study Medication for Period 1|The subject global evaluation of Tigan/placebo was completed by the subject at the visits in response to the question “Overall, how would you rate the study medication you received for nausea/vomiting?” Response choices were excellent, very good, good, fair, or poor.|Day 28 (Visit 3)|This secondary efficacy analysis was performed on the total number of subjects who responded to the evaluation within the Intention-to-Treat (ITT) population.||participants|||Number
743112|NCT00489255|Secondary|Modified Index of Nausea, Vomiting and Retching (INVR) Scores - Total Experience Score for Period 3|The INVR is an 8-item, 5 point Likert-type measurement of the patient’s perceived experience of nausea, vomiting and retching. Modified INVR scores collected once daily, rather than twice a day. INVR total score range from 0 to 32, with 32 indicative of the worst and 0 no symptom.|Days 57-84|Secondary efficacy analyses performed on the Intention-to-Treat (ITT) population.||score on a scale||Standard Deviation|Mean
743113|NCT00489255|Secondary|Modified Index of Nausea, Vomiting and Retching (INVR) Scores - Total Experience Score for Period 2|The INVR is an 8-item, 5 point Likert-type measurement of the patient’s perceived experience of nausea, vomiting and retching. Modified INVR scores collected once daily, rather than twice a day. INVR total score range from 0 to 32, with 32 indicative of the worst and 0 no symptom.|Days 29-56|Secondary efficacy analyses performed on the Intention-to-Treat (ITT) population.||score on a scale||Standard Deviation|Mean
743114|NCT00489255|Secondary|Modified Index of Nausea, Vomiting and Retching (INVR) Scores - Total Experience Score for Period 1|The INVR is an 8-item, 5 point Likert-type measurement of the patient’s perceived experience of nausea, vomiting and retching. Modified INVR scores collected once daily, rather than twice a day. INVR total score range from 0 to 32, with 32 indicative of the worst and 0 no symptom.|Days 1-28|This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population.||score on a scale||Standard Deviation|Mean
743115|NCT00489255|Secondary|Incidence of Nausea and/or Vomiting for Period 3||Days 57-84|Secondary efficacy analyses performed on the Intention-to-Treat (ITT) population.||participants|||Number
743116|NCT00489255|Secondary|Incidence of Nausea and/or Vomiting for Period 2||Days 29-56|Secondary efficacy analyses performed on the Intention-to-Treat (ITT) population.||participants|||Number
743117|NCT00489255|Secondary|Incidence of Nausea and/or Vomiting for Period 1||Days 1-28|Secondary efficacy analyses performed on the Intention-to-Treat (ITT) population.||participants|||Number
743118|NCT00489255|Primary|Incidence of Nausea and/or Vomiting During the Initial Titration of Apokyn® at the Visit on Day 1||Day 1 (Period 1, Visit 2)|Primary efficacy analyses performed on the Intention-to-Treat (ITT) population.||participants|||Number
743119|NCT00489268|Secondary|Percentage of Participants With Sub-squamous Intestinal Metaplasia|The secondary outcome sub-squamous intestinal metaplasia was defined as prevalence of buried glandular mucosa in the esophagus.|5 year|The analysis was done per protocol.||Percent of Participants|||Number
743120|NCT00489268|Secondary|Adverse Events|The secondary outcome adverse events was defined as any event that occurred during the course of the trial|5 year|The analysis was done per protocol.||Participants|||Number
743121|NCT00489268|Secondary|Progression of Histological Grade|Secondary outcomes of progression of histological grade was defined as proportion of participants who had progression of disease such as (i) prevalence of dysplasia; (ii) Kaplan-Meier CR-IM (Complete Response to Intestinal Metaplasia) survival analysis.|5 year|The analysis was done per protocol.||Percent of Participants|||Number
743122|NCT00489268|Primary|Percentage of Participants With Histological Clearance of Barrett's Metaplasia|The primary study outcomes were defined as the percent of patients with complete histological response to intestinal metaplasia (IM) (CR-IM). CR-IM means complete eradication of IM (diseased epithelium). A patient was considered a Complete Responder (CR) if all biopsies (100%) were negative for intestinal metaplasia (CR-IM).|5 year|The analysis was done per protocol.||Percent of Participants|||Number
743123|NCT00489359|Secondary|Phase 2 - Progression-Free Survival|Progression-free survival (PFS) is defined as the time from the date of study enrollment to the date of objectively determined PD or death from any cause, whichever comes first. For patients who are still alive at the time of analysis, and who do not have PD, PFS will be censored at the date of the last objective progression-free disease assessment.|baseline to measured progressive disease (up to 31 months)|"Protocol Qualified (PQ) population. This population includes all patients in the Phase 2 study who met the following requirements:
Histologic diagnosis of ovarian or primary peritoneal cancer, no concurrent chemotherapy, treatment with at least 1 dose of pemetrexed or 1 dose of carboplatin, presence of measurable disease as defined by RECIST."||Months||95% Confidence Interval|Median
743124|NCT00489359|Secondary|Phase 2 - Number of Participants With Adverse Events (Toxicity)|A listing of adverse events is located in the Reported Adverse Event module.|baseline through end of Phase 2 (up to 31 months)|Intention to Treat (ITT) population - all patients that consented and were successfully screened (note patient may or may not have received treatment; patients that were screen failures were not included in this population).||participants|||Number
747598|NCT00530842|Secondary|Static Lung Volumes|Trough IRV (Inspiratory Reserve Volume) after 4 weeks (measured by bodyphlethysmography)|4 weeks|FAS using imputed values||Litres||Standard Error|Mean
743125|NCT00489359|Secondary|Phase 2 - Overall Survival|Overall survival is defined as the time from the date of study enrollment to the date of death from any cause. This analysis was not done due to the high number of censored patients.|baseline to date of death from any cause (up to 31 months)|Protocol Qualified (PQ) population. This analysis was not done due to the high number of censored patients.||months||95% Confidence Interval|Median
743126|NCT00489359|Secondary|Phase 2 - Time to Treatment Failure|Time to treatment failure (TTTF) is defined as the time from the date of study enrollment to the date of the first observation of disease progression, death from any cause, or early discontinuation of treatment (any reason). For patients who are alive, progression-free, and have not discontinued early at the time of analysis, TTTF will be censored at the date of the last objective progression-free disease assessment.|First treatment to discontinuation of study drug, progressive disease, or death (up to 31 months)|"Protocol Qualified (PQ) population. This population includes all patients in the Phase 2 study who met the following requirements:
Histologic diagnosis of ovarian or primary peritoneal cancer, no concurrent chemotherapy, treatment with at least 1 dose of pemetrexed or 1 dose of carboplatin, presence of measurable disease as defined by RECIST."||Months||95% Confidence Interval|Median
743127|NCT00489359|Secondary|Phase 2 - Time to Disease Progression|Time to objective progressive disease (TTPD) is defined as the time from the date of study enrollment to the date of objectively determined Progressive Disease (PD). For patients who die without objective PD (including death from study disease), TTPD will be censored at the date of the last objective progression-free disease assessment. For patients who are still alive at the time of analysis, and who do not have PD, TTPD will be censored at the date of the last objective progression-free disease assessment.|baseline to measured progressive disease (up to 31 months)|"Protocol Qualified (PQ) population. This population includes all patients in the Phase 2 study who met the following requirements:
Histologic diagnosis of ovarian or primary peritoneal cancer, no concurrent chemotherapy, treatment with at least 1 dose of pemetrexed or 1 dose of carboplatin, presence of measurable disease as defined using RECIST."||Months||95% Confidence Interval|Median
743128|NCT00489359|Secondary|Phase 2 - Duration of Response (DOR)|Duration of response is defined as the time from first observation of Complete Response or Partial Response to the first observation of Progressive Disease or death from any cause. For patients who are still alive at the time of analysis, and who do not have Progressive Disease, duration of response will be censored at the date of the last objective progression-free disease assessment.|time of response to progressive disease (up to 31 months)|"Protocol Qualified (PQ) population. This population includes all patients in the Phase 2 study who met the following requirements:
Histologic diagnosis of ovarian or primary peritoneal cancer, no concurrent chemotherapy, treatment with at least 1 dose of pemetrexed or 1 dose of carboplatin, presence of measurable disease as defined by RECIST."||Months||95% Confidence Interval|Median
743129|NCT00489359|Secondary|Phase 2 - Time to Response (TTR)|Response is defined as CR (Complete Response) or PR (Partial Response) per RECIST criteria. Possible evaluations include: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the size of target lesions. Progressive Disease (PD): At least a 20% increase in the size of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|First treatment to response (up to 31 months)|"Protocol Qualified (PQ) population. This population includes all patients in the Phase 2 study who met the following requirements:
Histologic diagnosis of ovarian or primary peritoneal cancer, no concurrent chemotherapy, treatment with at least 1 dose of pemetrexed or 1 dose of carboplatin, presence of measurable disease as defined by RECIST."||Months||95% Confidence Interval|Median
743130|NCT00489359|Secondary|Phase 1 - Number of Participants With Tumor Response|Patients were analyzed by Cancer Antigen-125 (CA-125) response criteria and RECIST guidelines. Possible evaluations include: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the size of target lesions. Progressive Disease (PD): At least a 20% increase in the size of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|baseline measured to progressive disease (up to 18 months)|Intention to Treat (ITT) population - all patients that consented and were successfully screened (note patient may or may not have received treatment; patients that were screen failures were not included in this population).||Participants|||Number
743131|NCT00489359|Secondary|Phase 1 - Recommended Area Under the Curve (AUC) Dose of Carboplatin for Phase 2|MTD was to be used as Phase 2 recommended dose. MTD determined by increasing doses up to AUC 6 mg/mL*min based on pattern of DLT (Outcome #3). If none of 3 initial participants at given level had DLT in Cycle 1, enrollment proceeded to next dose level. If at least 2 participants had DLT in Cycle 1 at dose level, that dose level was considered MTD. However, based on results from Phase 2 Study (NCT00109096), further dose escalations were not explored: carboplatin dose was selected based on standard dose employed in control arm of first-line therapy for epithelial ovarian cancer (Bookman 2006).|baseline measured to progressive disease (up to 18 months)|Intention to Treat (ITT) population - all patients that consented and were successfully screened (note patient may or may not have received treatment; patients that were screen failures were not included in this population).||mg/mL*min|||Number
743132|NCT00489359|Secondary|Phase 1 - Recommended Dose of Pemetrexed for Phase 2|MTD was to be used as Phase 2 recommended dose. MTD was to be determined by increasing doses of pemetrexed up to 900 mg/m^2 based on observed pattern of dose limiting toxicity (DLT: See Outcome #3). If none of 3 initial participants at a given level had a DLT in Cycle 1, enrollment proceeded to next dose level. If at least 2 participants had a DLT in Cycle 1 at a dose level, that dose level was considered the MTD. However, based on results from another Phase 2 Study (NCT00109096), further dose escalations were not explored and dose was selected based on results of that Phase 2 Study.|baseline measured to progressive disease (up to 18 months)|Intention to Treat (ITT) population - all patients that consented and were successfully screened (note patient may or may not have received treatment; patients that were screen failures were not included in this population).||mg/m^2 (milligrams per square meter)|||Number
743133|NCT00489359|Secondary|Phase 1 - Number of Participants With Adverse Events (Toxicity)|A listing of adverse events is located in the Reported Adverse Event module.|baseline measured to progressive disease (up to 18 months)|Intention to Treat (ITT) population - all patients that consented and were successfully screened (note patient may or may not have received treatment; patients that were screen failures were not included in this population).||Participants|||Number
767264|NCT00693238|Primary|Acute Grade 3 (NCI CTC v4.0) or Higher Treatment-related Toxicity Rate.||6 months after the end of radiation therapy|||Participants|||Number
743134|NCT00489359|Secondary|Phase 1 - Number of Dose-Limiting Toxicities (DLTs)|"The following toxicities were considered DLT: CTCAE Grade 4 neutropenia (absolute neutrophil count [ANC] <0.5 × 10^9/L lasting ≥7 days. Febrile neutropenia (ANC <1.0 × 10^9/L, fever 38.5°C, and no documented infection). CTCAE Grade 4 thrombocytopenia (platelets <25.0 × 10^9/L).
Any hemorrhage with CTCAE Grade ≥3 thrombocytopenia (50.0 × 10^9/L). CTCAE Grade ≥3 nonhematologic toxicity (excluding nausea, vomiting, or CTCAE Grade 3 alanine transaminase (ALT) or aspartate aminotransferase (AST) that returned to baseline prior to next treatment).
Treatment delay more than 1 week due to toxicity."|baseline through end of Phase 1 (up to 18 months)|Intention to Treat (ITT) population - all patients that consented and were successfully screened (note patient may or may not have received treatment; patients that were screen failures were not included in this population).||DLT events|||Number
743135|NCT00489359|Primary|Phase 2 - Percentage of Participants With Overall Tumor Response (Response Rate)|"Response is defined as CR (Complete Response) or PR (Partial Response) per Response Evaluation Criteria in Solid Tumor (RECIST criteria). Possible evaluations include: CR: Disappearance of all target lesions. PR: At least a 30% decrease in the size of target lesions.
Response rate (%) = (number of patients with CR+PR/number of patients in Phase 2)*100"|baseline to measured progressive disease (PD) (up to 18 months)|"Protocol Qualified (PQ) population. This population includes all patients in the Phase 2 study who met the following requirements:
Histologic diagnosis of ovarian or primary peritoneal cancer, no concurrent chemotherapy, treatment with at least 1 dose of pemetrexed or 1 dose of carboplatin, presence of measurable disease as defined by RECIST."||percentage of participants||95% Confidence Interval|Number
743136|NCT00489359|Primary|Phase 1 - Maximum Tolerated Dose (MTD) of Pemetrexed in Combination With Carboplatin|MTD was to be determined by increasing doses of pemetrexed up to 900 mg/m^2 and carboplatin Area Under the Concentration-Time Curve (AUC) up to 6 mg/mL*min based on observed pattern of dose limiting toxicity (DLT). See Outcome #3 for DLT. If none of 3 initial participants at a given level experienced a DLT in Cycle 1, enrollment proceeded to the next dose level. If at least 2 participants experienced a DLT in Cycle 1 at a dose level, that dose level was considered the MTD. However, based on results from a different Phase 2 Study (NCT00109096), further dose escalations were not explored.|First treatment to toxicity (up to 18 months)|MTD was not determined in this study, so zero participants were analyzed.||mg/m^2|||Number
743137|NCT00489411|Secondary|Change in Average Pain From Week 8 to Week 12, as Measured by the BPI-SF Average Pain Severity Item|Change in average pain from Week 8 to Week 12, measured on day 1 of Weeks 8 and 13 by the Brief Pain Inventory Short Form (BPI-SF) was calculated as value at Day 1 of Week 8 minus value at Day 1 of Week 13 to yield positive improvement values. The BPI-SF contains 4 items assessing average, worst, least, and intermediate pain severity in the last 24 hours. Pain severity items are scored using an 11-point numeric rating scale (0, no pain; 10, pain as bad as you can imagine). Average pain severity was chosen as the primary outcome based on recommendations from the Initiative on Methods, Measurements, and Pain Assessment in Clinical Trials (IMMPACT). Patients completed the BPI-SF when thinking only about pain from peripheral neuropathy. The Cronbach's alpha reliability for the BPI ranges between 0.77 and 0.91. The comparison of interest was the difference between the 2 treatment groups in pain change during the crossover treatment period.|Day 1 of Week 8 to Day 1 of Week 13|Patients who completed crossover intervention and had complete data were included in the analysis.||units on a scale||95% Confidence Interval|Mean
743138|NCT00489411|Secondary|Change in the Total Score of the FACT/COG-NTX From Week 1 to Week 5|Patient-reported QOL was assessed using the Functional Assessment of Cancer Treatment, Gynecologic Oncology Group Neurotoxicity (FACT/GOG-Ntx) subscale on day 1 of weeks 1, 6, 8, and 13. The instrument contains 11 questions, assessing numbness, tingling, and discomfort in the hands or feet; difficulty hearing; tinnitus; joint pain or muscle cramps; weakness; or trouble walking, buttoning buttons, or feeling small shapes when placed in the hand. Items are scored from 0 to 4 (o, not at all; 4, very much) and summed (total score range, 0-44, with higher scores indicating a worse outcome). A 2- to 3-point change is defined as a clinically meaningful improvement in QOL per published recommendations specific to similar measures. The Mean Change During Initial Treatment Period in the FACT/GOG-Ntx total score are reported for each treatment arm and was calculated as value at Day 1 of Week 1 minus value at Day 1 of Week 6 to yield positive improvement values.|Day 1 of Week 1 to Day 1 of Week 6|Patients who completed initial intervention (prior to crossing over to receive alternate study drug duloxetine or placebo) and had complete data were included in the primary analysis.||units on a scale||95% Confidence Interval|Mean
743139|NCT00489411|Secondary|Change in Pain-related Functional Interference Score From Week 1 to Week 5, as Measured by the BPI-SF Interference Score|Change in pain-related functional interference score during the initial treatment period (Week 1 to Week 5), as measured by the BPI-SF interference score: Using an accepted method for accessing the influence of pain on function, 7 BPI-SF items were used to quantify the degree to which pain interfered with daily activities or function (0, does not interfere; 10 completely interferes). The 7 items were summed to obtain a total interference score, which ranged from 0 to 70, with lower scores meaning less interference. The mean change in pain-related functional interference score during the initial treatment period are reported below for each treatment arm and was calculated as value at Day 1 of Week 1 minus value at Day 1 of Week 6 to yield positive improvement values.|Day 1 of Week 1 to Day 1 to Week 6|Patients who completed initial intervention (prior to crossing over to receive alternate study drug duloxetine or placebo) and had complete data were included in the primary analysis.||units on a scale||95% Confidence Interval|Mean
743140|NCT00489411|Primary|Change in Average Pain From Week 1 to Week 5, as Measured by the BPI-SF Average Pain Severity Item|Change in average pain from Week 1 to Week 5, measured on day 1 of Weeks 1 and 6 by the Brief Pain Inventory Short Form (BPI-SF) was calculated as value at Day 1 of Week 1 minus value at Day 1 of Week 6 to yield positive improvement values. The BPI-SF contains 4 items assessing average, worst, least, and intermediate pain severity in the last 24 hours. Pain severity items are scored using an 11-point numeric rating scale (0, no pain; 10, pain as bad as you can imagine). Average pain severity was chosen as the primary outcome based on recommendations from the Initiative on Methods, Measurements, and Pain Assessment in Clinical Trials (IMMPACT). Patients completed the BPI-SF when thinking only about pain from peripheral neuropathy. The Cronbach’s alpha reliability for the BPI ranges between 0.77 and 0.91. The comparison of interest was the difference between the 2 treatment groups in pain change during the initial treatment period.|Day 1 of Week 1 to Day 1 of Week 6|Patients who completed initial intervention (prior to crossing over to receive alternate study drug duloxetine or placebo) and had complete data were included in the primary analysis.||units on a scale||95% Confidence Interval|Mean
743141|NCT00489424|Secondary|Change From Baseline in Visual Analog Scale (VAS) Measurement of Symptom Severity|Effect on severity of symptoms following i.v. infusion of zoledronic acid 5 mg. The VAS is a 100-mm linear visual analog scale (0 = no symptoms to 100 = severe symptoms). The baseline VAS measurement was defined as the VAS measurement recorded prior to the infusion.|0 - 3 days|Intent to Treat (ITT) population. Number of participants analyzed may vary from ITT population due to some patients not reporting baseline or post baseline VAS measurement. Calculating change requires both baseline and post baseline values to be present.||units on a scale||Standard Deviation|Mean
743142|NCT00489424|Secondary|Proportion of Patients Reporting Severe Questionnaire Symptoms.|A severe questionnaire symptom was defined as experiencing a severe specified symptom (feeling feverish, experiencing headaches, having aches and pains of muscles and joints) at least once post-baseline.|0 - 3 days|Intent to Treat (ITT) population.||proportion of patients|||Number
743143|NCT00489424|Secondary|Proportion of Patients With a Major Increase (Worsening) in Severity of Questionnaire Symptoms.|A major increase (worsening) in severity was defined as an increase in severity of 2 units or more from baseline at least once during the 3 days immediately following i.v. infusion of zoledronic acid 5 mg. The severity of the symptom was evaluated using a 4-point categorical scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe).|0 - 3 days|Intent to Treat (ITT) population.||proportion of patients|||Number
743144|NCT00489424|Secondary|Time to First Rescue Medication After Infusion of Zoledronic Acid 5 mg.|Patients who experienced severe discomfort after their first home measurements and self-administration of study medication were allowed to take ibuprofen (200 mg tablets every 4-6 hours as needed) as rescue medication while continuing to take their study medication.|0 - 3 days|Number of patients who took rescue medication at least once. Two patients who took rescue medication in fluvastatin arm were not included in analysis since the time rescue medication was taken was not recorded.||hours||Standard Deviation|Mean
743145|NCT00489424|Secondary|Number of Rescue Medication Tablets Taken|Patients who experienced severe discomfort after their first home measurements and self-administration of study medication were allowed to take ibuprofen (200 mg tablets every 4-6 hours as needed) as rescue medication while continuing to take their study medication.|0 - 3 days|Number of patients who took rescue medication at least once. One patient in acetaminophen arm was not included in analysis since the number of tablets taken was not recorded.||tablets||Standard Deviation|Mean
743146|NCT00489424|Secondary|Proportion of Patients Who Used Rescue Medication.|Patients that took rescue medication >= 1 time during the 3-day period after i.v. infusion of zoledronic acid 5 mg. Patients who experienced severe discomfort after their first home measurements and self-administration of study medication were allowed to take ibuprofen (200 mg tablets every 4-6 hours as needed) as rescue medication while continuing to take their study medication.|0 - 3 days|Intent to Treat (ITT) population. One patient who used rescue medication in acetaminophen arm and two patients in fluvastatin arm were not included in analysis due to lack of documentation regarding use and exposure of rescue medication.||proportion of patients|||Number
743147|NCT00489424|Secondary|Proportion of Patients With a Clinically Significant Increase in Oral Body Temperature.|Clinically significant increase in oral body temperature >= 1 time during the 3-day period after i.v. infusion of zoledronic acid 5 mg. A clinically significant increase in body temperature was defined as an increase of at least 1 degree Celsius from baseline and a mean oral body temperature reading of at least 38.5 degrees Celsius occurring at least once during the 3-day treatment period.|0 - 3 days|Intent to Treat (ITT) population.||proportion of patients|||Number
743148|NCT00489424|Primary|Proportion of Patients With a Clinically Significant Increase in Oral Body Temperature or Use of Rescue Medication.|Clinically significant increase in oral body temperature or used rescue medication ibuprofen >= 1 time during the 3-day period after i.v. infusion of zoledronic acid 5 mg. A clinically significant increase in body temperature was defined as an increase of at least 1 degree Celsius from baseline and a mean oral body temperature reading of at least 38.5 degrees Celsius occurring at least once during the 3-day treatment period.|0 - 3 days|Intent to Treat (ITT) population.||proportion of patients|||Number
743149|NCT00495495|Secondary|Laser Fluorescence Progression-12 Month (Increase at Least 10)|The change in DIAGNOdent measurements between baseline and twelve-month visits was used as an additional secondary endpoint. Clinically significant changes for DIAGNOdent indicating caries progression would be an increase in DIAGNOdent reading of 10 or more units. DIAGNOdent reading using a scale from 00 to 99, with 00 indicating no caries activity and 99 indicating a high level of activity.|one year|Analyses were based on per protocol subjects, defined as all randomized subjects with no major protocol violations.||teeth|Participants||Number
743150|NCT00495495|Secondary|Laser Fluorescence Progression-12 Month (Increase From <=20 to >=30)|The change in DIAGNOdent measurements between baseline and twelve-month visits was used as an additional secondary endpoint. Clinically significant changes for DIAGNOdent indicating caries progression would be an increase in DIAGNOdent reading of 10 or more units or an increase in DIAGNOdent reading from below 20 to above 30 units. DIAGNOdent reading using a scale from 00 to 99, with 00 indicating no caries activity and 99 indicating a high level of activity.|one year|Analyses were based on per protocol subjects, defined as all randomized subjects with no major protocol violations (subjects who completed all four treatment/examination visit at Baseline, 3-, 6-, 9-month as well as Final examination at 12-month.||teeth|Participants||Number
743151|NCT00495495|Secondary|Progression of Radiographic Scores at 12 Months|"Clinically significant changes for Bitewing x-rays indicating caries progression would be changes in x-ray criterion for lesion presence from “no” to “yes” or for lesion depth to a D1 or higher. The occlusal surface of study teeth will be evaluated using the following scale:
Lesion presence: yes /no
Lesion depth:
E1 = outer half of enamel E2 = inner half of enamel D1 = outer third of dentin D2 = middle third of dentin D3 = inner third of dentin or greater/pulpal exposure"|one year|Analyses were based on per protocol subjects, defined as all randomized subjects with no major protocol violations (subjects who completed all four treatment/examination visit at Baseline, 3-, 6-, 9-month as well as Final examination at 12-month.||teeth|Participants||Number
743184|NCT00495677|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 hour (pre-dose) on Day 1 to 9; 0 hour (pre-dose), 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 10; Day 12, 13, 15 morning|Pharmacokinetic parameter analysis population included all participants who were randomized, treated and had at least 1 of the pharmacokinetic parameters of interest in the study.||hours||Full Range|Median
767420|NCT00694304|Primary|Number of Patients With Adverse Events (AEs)||Baseline to end of the 4-week safety follow-up period|APTS||participants|||Number
743152|NCT00495495|Secondary|Change in Caries Lesion Activity|"Change in caries lesion activity at One Year. All teeth were considered Active at Baseline
Caries Lesion Activity score:
= Inactive – surface of enamel appears whitish, brownish or black. Enamel may be shiny and feels hard and smooth when the tip of the probe is moved gently across the surface.
= Active lesion – surface of enamel appears whitish/yellowish opaque with loss of luster. The surface feels rough when the tip of the probe is moved gently across the surface."|Baseline and one year|"Analyses were based on per protocol subjects, defined as all randomized subjects with no major protocol violations.
Clinically significant changes for Activity Scores were indicated by a change in caries activity status from active to inactive. It should be noted that all teeth were considered active at baseline."||teeth|Participants||Number
743153|NCT00495495|Primary|ICDAS Severity Value|"Clinically significant changes indicating caries progression are defined as changes in ICDAS severity values from 1 or 2 to a 3 or higher, or from a 3 or 4 to a 5 or higher. The severity criteria are as follows:
0 = Sound tooth surface.
= First visual change in enamel.
= Distinct visual change in enamel.
= Localized enamel breakdown due to caries with no visible dentin.
= Underlying dark shadow from dentin, with or without localized enamel breakdown.
= Distinct cavity with visible dentin.
= Extensive distinct cavity with visible dentin."|Baseline and One Year|The study utilized a split-mouth design. The results posted are for the Per Protocol dataset. Subjects who completed all four treatment/examination visits as well as final examination visit without major protocol violations were included in this dataset.||teeth|Participants||Number
743154|NCT00495521|Secondary|Change in Global Physician Assessment of Disease Activity From Baseline to Study Completion||4 weeks||||||
743155|NCT00495521|Secondary|Change in Hgb, ESR, CRP, Platelet Count, Calprotectin From Baseline and Time to Normalization||2 weeks and 4 weeks||||||
743156|NCT00495521|Secondary|Time to Normalization of All Other Components in the Diary||up to 4 weeks||||||
743157|NCT00495521|Secondary|Absence of Night Time Stools, if They Were Present on Entry, and Time to Disappearance||up to 4 weeks||||||
743158|NCT00495521|Secondary|Change From Baseline in the Patient's General Sense of Disease Activity as Recorded in the Individual Daily Diary||4 weeks||||||
743159|NCT00495521|Secondary|Change in IMPACT-III From Baseline to 4 Weeks||4 weeks||||||
743160|NCT00495521|Secondary|Rate of Remission as Defined by the Decrease in PCDAI < 10 by 4 Weeks||4 weeks||||||
743161|NCT00495521|Secondary|Rate of Response as Defined by the Decrease in PCDAI of 12.5 Points by 4 Weeks||4 weeks||||||
743162|NCT00495521|Secondary|Time to Response and/or Remission Including Time to Change in HBI, According to Elements of the Daily Patient Diary||up to 4 weeks||||||
743163|NCT00495521|Secondary|Rate of Remission as Defined by the Decrease in HBI to Less Than 3 by 4 Weeks||4 weeks||||||
743164|NCT00495521|Secondary|Rate of Response as Defined by a Reduction in HBI to Less Than 5 by 4 Weeks||4 weeks||||||
743165|NCT00495521|Secondary|Rate of Remission|Rate of remission was defined by a decrease in modified Crohn's Disease Activity Index (mCDAI) > 100 points and total mCDAI < 150 by 4 weeks|4 weeks|||Participants|||Count of Participants
743166|NCT00495521|Primary|Reduction in the Modified Crohn's Disease Activity Index (mCDAI) Score of >70 Points by 4 Weeks Compared With Baseline|Reduction in the Modified Crohn's Disease Activity Index (mCDAI) score of >70 points by 4 weeks after randomization compared with baseline|4 weeks|||participants|||Number
743167|NCT00495586|Secondary|Number of Days Till the Next Exacerbation|For the assessment of the time till next exacerbation patients were monitored over a period of 365 days on a three-monthly basis. Patients were instructed to contact their physician immediately if there was any change in their health status. Diagnosis of a new exacerbation was based on the same clinical criteria described previously. For the calculation of time to the next exacerbation, all clinical failures occurring during therapy were counted as zero exacerbation-free interval days.|One year|Patients with clinical success at the end of therapy visit||Days||Inter-Quartile Range|Median
743168|NCT00495586|Primary|Number of Patients Who Were Cured|Cure defined as the disappearance of the acute signs and symptoms related to the infection, with complete return to the previous situation of stability|Day 9-11|Clinical cure at end of therapy visit at day 9-11 in the ITT population||Participants|||Number
743169|NCT00495612|Secondary|Duration of Allergen Exposure During the Cat Allergen Exposure Challenge at Week 16|The challenge was stopped if a patient stated that they were extremely uncomfortable and would like to leave the room, the FEV1 has decreased by 50% from the baseline value, or after 60 minutes of exposure. The duration of allergen exposure was the time from when the patient entered the exposure room until the challenge stopped, with a maximum of 60 minutes. A longer duration indicates greater tolerance of the allergen exposure.|Week 16|Modified intent-to-treat population: All randomized patients that received at least 1 dose of study drug and who had at least 1 primary efficacy data point, ie, at least 1 FEV1 measurement during the 1-hour cat allergen exposure at Week 16.||Minutes||95% Confidence Interval|Median
743170|NCT00495612|Secondary|Area Under the Curve (AUC) of Change in Nasal-ocular Symptom Score (NOSS) During a 1-hour Cat Allergen Exposure From Pre-challenge at Week 16|The NOSS was defined as the total of 4 sub-scores: Nasal congestion, rhinorrhea, nasal pruritus, ocular pruritus, and ocular tearing. Each sub-score was rated by the patient on a scale of 0-3 (0=none, 1=mild, 2=moderate, and 3=severe) immediately prior to and approximately every 5 minutes during chamber exposure. The maximum NOSS was 15 points. A lower score indicates a reduced response to the allergen exposure and fewer nasal-ocular symptoms.|Week 16|Modified intent-to-treat population: All randomized patients that received at least 1 dose of study drug and who had at least 1 primary efficacy data point, ie, at least 1 FEV1 measurement during the 1-hour cat allergen exposure at Week 16.||Units on a scale*hours||Standard Deviation|Mean
743171|NCT00495612|Secondary|Area Under the Curve (AUC) of Change in Chest Symptom Score During a 1-hour Cat Allergen Exposure From Pre-challenge at Week 16|The chest symptom score was defined as the total of 4 sub-scores: Chest tightness, wheezing, shortness of breath, and cough. Each sub-score was rated by the patient on a scale of 0-3 (0=none, 1=mild, 2=moderate, and 3=severe) immediately prior to and approximately every 5 minutes during chamber exposure. The maximum chest symptom score was 12 points. A lower score indicates a reduced response to the allergen exposure and fewer respiratory symptoms.|Week 16|Modified intent-to-treat population: All randomized patients that received at least 1 dose of study drug and who had at least 1 primary efficacy data point, ie, at least 1 FEV1 measurement during the 1-hour cat allergen exposure at Week 16.||Units on a scale*hours||Standard Deviation|Mean
743172|NCT00495612|Secondary|Maximum Percent Change in Forced Expiratory Volume in 1 Second (FEV1) During a 1-hour Cat Allergen Exposure From Pre-challenge at Week 16|Spirometry was performed prior to chamber exposure, approximately every 10 minutes during exposure, and approximately every 20 minutes after exposure until FEV1 returned to within 10% of baseline value. A smaller change in FEV1 indicates a reduced response to the allergen exposure.|Week 16|Modified intent-to-treat population: All randomized patients that received at least 1 dose of study drug and who had at least 1 primary efficacy data point, ie, at least 1 FEV1 measurement during the 1-hour cat allergen exposure at Week 16.||Percent change||Standard Deviation|Mean
743173|NCT00495612|Secondary|Percent Change in Forced Expiratory Volume in 1 Second (FEV1) at 20 Minutes of a 1-hour Cat Allergen Exposure From Pre-challenge at Week 16|Spirometry was performed prior to chamber exposure, approximately every 10 minutes during exposure, and approximately every 20 minutes after exposure until FEV1 returned to within 10% of baseline value. A smaller change in FEV1 indicates a reduced response to the allergen exposure.|Week 16|Modified intent-to-treat population: All randomized patients that received at least 1 dose of study drug and who had at least 1 primary efficacy data point, ie, at least 1 FEV1 measurement during the 1-hour cat allergen exposure at Week 16.||Percent change||Standard Deviation|Mean
743174|NCT00495612|Primary|Area Under the Curve (AUC) of Percent Change in Forced Expiratory Volume in 1 Second (FEV1) Over a 1-hour Cat Allergen Exposure From Pre-challenge at Week 16|Spirometry was performed prior to chamber exposure, approximately every 10 minutes during exposure, and approximately every 20 minutes after exposure until FEV1 returned to within 10% of the baseline value. A smaller change in FEV1 indicates a reduced response to the allergen exposure.|Week 16|Modified intent-to-treat population: All randomized patients that received at least 1 dose of study drug and who had at least 1 primary efficacy data point, ie, at least 1 FEV1 measurement during the 1-hour cat allergen exposure at Week 16.||Percent change from pre-challenge*hours||Standard Deviation|Mean
743175|NCT00495625|Primary|Number of Participants With Progressive Disease (PD) at Interim Analysis|Progressive Disease Rate. Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Response and progression were evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000].|On Treatment to Off Study - average of 7 months per participant|17 of the 23 patients that were enrolled at time of Interim Analysis (patients enrolled between 10/13/06 and 9/24/07) were evaluable for response.||participants|||Number
743176|NCT00495625|Primary|Number of Participants With Stable Disease (SD) at Interim Analysis|Stable Disease (SD) Rate at Interim Analysis. Stable Disease (SD): Neither sufficient shrinkage to qualify for Partial Response (PR) nor sufficient increase to qualify for Progressive Disease (PD), taking as reference the smallest sum longest diameter (LD) since the treatment started. Response and progression were evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000].|On Treatment to Off Study - average of 7 months per participant|17 of the 23 patients that were enrolled at time of Interim Analysis (patients enrolled between 10/13/06 and 9/24/07) were evaluable for response.||participants|||Number
743177|NCT00495625|Secondary|Number of Participants With Serious Adverse Events (SAEs)|The toxicity of sunitinib malate in the treatment in unresectable HCC|On Treatment to Off Study - average of 7 months per participant|All participants||participants|||Number
743178|NCT00495625|Secondary|Number of Participants With Overall Survival (OS)|Overall survival (OS) of sunitinib malate in the treatment in unresectable HCC|On Treatment to Off Study - average of 7 months per participant|Participants who had not expired on their off study date.||participants|||Number
743179|NCT00495625|Secondary|Participant Time to Tumor Progression (TTP)|Investigators planned to determine the time to tumor progression (TTP) of sunitinib malate in the treatment in unresectable Hepatocellular Cancers (HCC). TTP is defined as the duration of time from start of treatment to time of progression.|On Treatment to Off Study - average of 7 months per participant|Not analyzed. The Principal Investigator who initiated the study left Moffitt before reaching the target enrollment required to perform the planned analysis.||months||Full Range|Mean
743180|NCT00495625|Primary|Number of Participants With Partial Response (PR) at Interim Analysis|Partial Response at Interim Analysis. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (unidimensional measurement) of target lesions, taking as reference the baseline sum longest diameter (LD). Response was evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000].|On Treatment to Off Study - average of 7 months per participant|17 of the 23 patients that were enrolled at time of Interim Analysis (patients enrolled between 10/13/06 and 9/24/07) were evaluable for response.||participants|||Number
743181|NCT00495677|Other Pre-specified|Number of Participants With Chemokine Receptor 5 (CCR5) Delta 32 Genotyping and Immunophenotyping|CCR5 Delta 32 genotyping and immunophenotyping was to be done to assess CCR5 Delta 32 status, other CCR5 polymorphisms, enzymes involved in drug metabolism and/or drug transport proteins in order to measure the impact of genetic variation with respect to PF-00232798 in case any unusual patterns of response or an unexplained excess of adverse events occurred.|Pre-dose on Day 1|Results for this outcome were not analyzed because there were no unusual patterns of response or an unexplained excess of adverse events that warranted genotyping.|||||
743182|NCT00495677|Other Pre-specified|Number of Participants With Viral Tropism and Resistance|Virus tropism was determined using the Monogram PhenoSense Entry assay; standard Trofile tropisim assay was used for Stage 1 and enhanced sensitivity Trofile tropisim assay was used for Stage 2.|Screening, pre-dose on Day 1; Day 11, 25|Results for this outcome was not reported because data was collected in individual participant listings, but not summarized for analyses.|||||
743183|NCT00495677|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)|AUCtau= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to the time end of dosing interval (24 hours post-dose).|0 hour (pre-dose), 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 10|Pharmacokinetic parameter analysis population included all participants who were randomized, treated and had at least 1 of the pharmacokinetic parameters of interest in the study.||nanogram*hour per milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
747599|NCT00530842|Secondary|Static Lung Volumes|Trough IRV (Inspiratory Reserve Volume) after 8 weeks (measured by bodyphlethysmography)|8 weeks|FAS using imputed values||Litres||Standard Error|Mean
743185|NCT00495677|Secondary|Maximum Observed Plasma Concentration (Cmax)||0 hour (pre-dose) on Day 1 to 9; 0 hour (pre-dose), 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 10; Day 12, 13, 15 morning|Pharmacokinetic parameter analysis population included all participants who were randomized, treated and had at least 1 of the pharmacokinetic parameters of interest in the study.||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
743186|NCT00495677|Secondary|Number of Participants With Time to Rebound of Human Immunodeficiency Virus (HIV) Viral Load|The time to rebound of viral load was calculated as the time from the last dose to the time of the first occasion at which the viral load was greater than the baseline value. Results are reported for number of participants who rebound within specified days from last dose and who did not rebound up to Day 25.|Day 1 up to Day 25|Pharmacodynamic population included all participants who were randomized, treated and had at least 1 post-dose HIV viral load measurement in the study.||participants|||Number
743187|NCT00495677|Primary|Change From Baseline in Log 10-transformed Human Immunodeficiency Virus (HIV) Viral Load at Day 11|Viral load was determined using the Roche COBAS Taqman HIV-1 assay with a lower limit of detection of 40 copies per milliliter (copies/mL). Samples with an initial reading of less than 1,000,000 copies/mL were diluted into range and re-assayed.|Baseline, Day 11|Pharmacodynamic population included all participants who were randomized, treated and had at least 1 post-dose HIV viral load measurement in the study.||log10 copies/mL||Standard Deviation|Mean
743188|NCT00495755|Secondary|The Effect of Alemtuzumab Therapy on Parameters of Cellular and Humoral Immunity in the Late Post Transplant Period. This Information is Exploratory in Nature Only Due to the Heterogeneity of the Anticipated Patient Population.||12||||||
743189|NCT00495755|Secondary|The Efficacy of a Four-week Course of Alemtuzumab in Patients With Steroid-refractory Chronic GVHD (cGVHD).|Efficacy measured as complete response (CR), partial response (PR), stable disease (SD) and cGVHD progression (PD). CR is defined as absence of all measurable or symptomatic cGVHD, PR is defined as a remission in some but not all involved organs. SD is defined as no measurable change in GVHD and PD is defined as progression in at least one involved organ.|12 weeks|||participants|||Number
743190|NCT00495755|Primary|The Maximum Tolerated Dose (MTD) of a Four-week Course of Alemtuxumab in Chronic GVHD for Patients With an Incomplete Response to Steroids|MTD: The dose at which fewer or equal to 2/6 experience a dose-limiting toxicity|12 weeks|||mg|||Number
743191|NCT00495794|Secondary|LDL Control||12 months after invention period|Includes only participants with a LDL in the 12 months after the intervention period.||mg/dl||Standard Deviation|Mean
743192|NCT00495794|Secondary|A1c Control||12 months after intervention period|Includes only participants with an A1c in the 12 months after the intervention period.||percentage of total hemoglobin||Standard Deviation|Mean
743193|NCT00495794|Primary|Change in Systolic Blood Pressure||6 months prior to 6 months after the intervention period|intention to treat analysis||mmHg||95% Confidence Interval|Mean
743194|NCT00496054|Primary|The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for P1||Baseline and Approximately 6 Months|The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results||Titer||95% Confidence Interval|Geometric Mean
743195|NCT00496054|Primary|The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G4||Baseline and Approximately 6 Months|The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results||Titer||95% Confidence Interval|Geometric Mean
743196|NCT00496054|Primary|The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G3||Baseline and Approximately 6 Months|The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results||Titer||95% Confidence Interval|Geometric Mean
743197|NCT00496054|Primary|The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G2||Baseline and Approximately 6 Months|The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results||Titer||95% Confidence Interval|Geometric Mean
743198|NCT00496054|Primary|The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G1||Baseline and Approximately 6 Months|The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results||Titer||95% Confidence Interval|Geometric Mean
743199|NCT00496054|Primary|The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for P1||Baseline and Approximately 6 Months|The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data||Titer||95% Confidence Interval|Geometric Mean
743200|NCT00496054|Primary|The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G4||Baseline and Approximately 6 Months|The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data||Titer||95% Confidence Interval|Geometric Mean
743201|NCT00496054|Primary|The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G3||Baseline and Approximately 6 Months|The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data||Titer||95% Confidence Interval|Geometric Mean
743202|NCT00496054|Primary|The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G2||Baseline and Approximately 6 Months|The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data||Titer||95% Confidence Interval|Geometric Mean
743203|NCT00496054|Primary|The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G1||Baseline and Approximately 6 Months|The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data||Titer||95% Confidence Interval|Geometric Mean
743221|NCT00496080|Secondary|Maintenance of Menses|Number of participants with continuation of menstrual cycles without interruption for three consecutive months|12 months|ITT (No data for 30 participants)||participants|||Number
768708|NCT00699400|Secondary|Number of Live Babies||Birth of one or more live babies|||Number of live births|||Number
743204|NCT00496054|Primary|The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for IgA||Baseline and Approximately 6 Months|The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results||Titer||95% Confidence Interval|Geometric Mean
743205|NCT00496054|Primary|The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for IgA||Baseline and Approximately 6 Months|The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data||Titer||95% Confidence Interval|Geometric Mean
743206|NCT00496054|Primary|The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in P1 Serum Neutralizing Antibodies(SNA)||Baseline and Approximately 6 Months|The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results||Percentage of Participants|||Number
743207|NCT00496054|Primary|The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G4 Serum Neutralizing Antibodies(SNA)||Baseline and Approximately 6 Months|The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results||Percentage of Participants|||Number
743208|NCT00496054|Primary|The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G3 Serum Neutralizing Antibodies(SNA)||Baseline and Approximately 6 Months|The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results||Percentage of Participants|||Number
743209|NCT00496054|Primary|The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G2 Serum Neutralizing Antibodies(SNA)||Baseline and Approximately 6 Months|The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results||Percentage of Participants|||Number
743210|NCT00496054|Primary|The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G1 Serum Neutralizing Antibodies(SNA)||Baseline and Approximately 6 Months|The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results||Percentage of Participants|||Number
743211|NCT00496054|Primary|The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in P1 Serum Neutralizing Antibodies(SNA)||Baseline and Approximately 6 Months|The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data||Percentage of Participants|||Number
743212|NCT00496054|Primary|The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G4 Serum Neutralizing Antibodies(SNA)||Baseline and Approximately 6 Months|The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data||Percentage of Participants|||Number
743213|NCT00496054|Primary|The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G3 Serum Neutralizing Antibodies(SNA)||Baseline and Approximately 6 Months|The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data||Percentage of Participants|||Number
743214|NCT00496054|Primary|The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G2 Serum Neutralizing Antibodies(SNA)||Baseline and Approximately 6 Months|The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data||Percentage of Participants|||Number
743215|NCT00496054|Primary|The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G1 Serum Neutralizing Antibodies (SNA)||Baseline and Approximately 6 Months|The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data||Percentage of Participants|||Number
743216|NCT00496054|Primary|The Percentage of Participants Who Exhibit a 3 Fold Rise or Greater From Baseline to Approximately 6 Months in Rotavirus Specific Serum in IgA||Baseline and Approximately 6 Months|The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results.||Percentage of Participants|||Number
743217|NCT00496054|Primary|The Percentage of Participants Who Exhibit a 3 Fold Rise or Greater From Baseline to Approximately 6 Months in Rotavirus Specific Serum in IgA||Baseline and Approximately 6 Months|The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data||Percentage of Participants|||Number
743218|NCT00496080|Secondary|Mean Improvement in Uterine Fibroid Symptom Quality of Life (UFS-QOL) Symptom Severity Scores|"Number of participants categorized as better in the UFS-QOL sympton severity questionnaire, indicating an overall improvement in fibroid related symptoms. On this scale, higher scores are indicative of increasing symptom distress, with a maximum(worst)score of 100 and a minimum (best)score of 0. Better was defined as a change of -11 or less from baseline at 12 mo."|From baseline to 12 months|ITT (No data for 18 participants.)||participants|||Number
743219|NCT00496080|Secondary|Decrease in Fibroid Bulk|"Number of participants with a minimum 15% decrease in fibroid bulk based on independent magnetic resonance imaging (MRI) review from baseline at 12 mo.
Note: As per protocol, MRIs were planned only for subjects 1 - 40, 81 - 120, and 161-200."|From baseline to 12-months|ITT (Due to early termination, only 39 subjects had MRIs. No data for 8 participants.)||participants|||Number
743220|NCT00496080|Secondary|Procedural Satisfaction|"Number of participants with responses of either satisfied or very satisfied on a qualitative survey that ranged from very dissatisfied (worst) to very satisfied (best)"|12 months|ITT (No data for 19 participants)||participants|||Number
743222|NCT00496080|Secondary|Mean Improvement in Health Related Quality of Life (HRQOL) Scores|"Participants categorized as better in the total UFS-QOL questionnaire, indicating an overall improvement in health-related quality of life. On this scale, higher scores are indicative of better quality of life, with a maximum(best)score of 100 and a minimum (worst)score of 0. Better was defined as a change of +12 or more from baseline at 12 mo."|From baseline to 12 months|ITT (No data for 20 participants)||participants|||Number
743223|NCT00496080|Primary|Improvement in Pictorial Blood Loss Assessment Chart (PBLAC) Score|Number of participants with a 50% or greater reduction in PBLAC score from baseline at 12 mo and a PBLAC score of less than 250. PBLAC is a simple validated semiquantitative method of measuring total menstrual blood loss using a pictorial representation of blood loss, where higher scores indicate more blood loss. This hybrid endpoint combined the reduction in PBLAC score with the total PBLAC score.|From baseline to 12 months|ITT (No data for 18 participants)||participants|||Number
743224|NCT00496080|Primary|No Surgical Re-intervention|Number of participants without any subsequent surgical procedure intended to manage fibroid symptoms performed. Potential procedures included surgical hysterectomy or dilatation and curettage (D&C) for treatment of menorrhagia; uterine artery embolization (UAE) or laparoscopic uterine artery occlusion; endometrial resection or ablation; myomectomy or myolysis.|Study completion|ITT (Data missing for 5 participants)||participants|||Number
743225|NCT00496197|Secondary|Number of Participants Who Died||Baseline up to Week 6 Follow-up (EOS) or 30 days after last dose of study drug (whichever was later)|Safety analysis set||participants|||Number
743226|NCT00496197|Secondary|Number of Participants With Non-serious and Serious Adverse Events|AEs are any untoward medical occurrence in a clinical investigation subject administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. SAEs are any untoward medical occurrence at any dose that results in death, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, results in congenital anomaly or birth defect.|Baseline up to Week 6 Follow-up (EOS) or 30 days after last dose of study drug (whichever was later)|Safety analysis set. An event may have been reported as both a serious and non-serious adverse event, however, what is presented are distinct events; participants may be counted as having experienced > 1 event.||participants|||Number
743227|NCT00496197|Secondary|Number of Participants Per Specified Cause of Death|Cause of death (includes all-cause and attributable to Candida infection) reported based on death due to Serious Adverse Events (SAEs). SAEs are any untoward medical occurrence at any dose that results in death, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, results in congenital anomaly or birth defect. Participants may be counted with > 1 cause of death if multiple causes were present.|Baseline up to Week 6 Follow-up (EOS) or 30 days after last dose of study drug (whichever was later)|Safety analysis set is the same as the Intent-to-Treat population (ITT) and includes all participants who had taken at least 1 dose of study medication. N=number of participants who died with cause of death reported as Serious Adverse Events.||participants|||Number
743228|NCT00496197|Secondary|Medical Resource Utilization (MRU): Duration of Overall Therapy (Days)|Overall therapy includes Intravenous and Oral therapy. Participants were to receive at least 5 days and a maximum of 28 days of IV anidulafungin. After that, participants could continue treatment with oral fluconazole or voriconazole for at least 14 days from the day of last positive culture.|Baseline up to End of Treatment (Day 5 up to Day 42)|Intent to Treat (ITT) population includes all participants who received at least 1 dose of study medication.||days||Standard Deviation|Mean
743229|NCT00496197|Secondary|Medical Resource Utilization (MRU): Duration of Intravenous Therapy (Days)|Analysis of length of hospital stay based on Kaplan-Meier survival techniques.|Baseline up to End of Intravenous treatment (Day 5 up to Day 28)|MITT; N=number of participants with analyzable data at observation. Length of hospital stay censored at Week 6 Follow-up (EOS).||days||Standard Error|Mean
743230|NCT00496197|Secondary|Medical Resource Utilization (MRU): Duration of Intensive Care Unit or Critical Care Unit Stay (Days)|Analysis of length of hospital stay based on Kaplan-Meier survival techniques.|Baseline up to 6 Week Follow-up (EOS)|MITT; N=number of participants with analyzable data at observation. Length of hospital stay censored at Week 6 Follow-up (EOS).||days||Standard Error|Mean
743231|NCT00496197|Secondary|Medical Resource Utilization (MRU): Duration of Hospital Stay (Days)|Measured as time to dischargeable (medically dischargeable status) and as time to discharge (actual discharge). Analysis of length of hospital stay based on Kaplan-Meier survival techniques.|Baseline up to 6 Week Follow-up (EOS)|MITT; N=number of participants with analyzable data at observation. Time to dischargeable and time to discharge censored at Week 6 Follow-up (EOS).||days||Standard Error|Mean
743232|NCT00496197|Secondary|Time (75% Quartile Point Estimate) to Negative Blood and / or Tissue Culture for Candida Species|Participants with a negative culture on Day 1 were not included in the analysis. For participants with a positive culture on Day 1, the first day on which there was a negative culture was determined and then compared to the result of the next culture. If the next culture was also negative, or the next culture was positive but the interval between the 2 cultures was > 3 days, the earlier of the 2 cultures was the day of first negative blood culture. If next culture was positive and taken within 3 days of the previous culture, the process was repeated with the next negative blood culture.|Baseline (Day 1) up to Week 6 Follow-up (EOS)|MITT; Confidence interval (CI) for the median could not be calculated by the software because no event time met the criteria for inclusion into the CI.||days||95% Confidence Interval|Number
743233|NCT00496197|Secondary|Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at Week 6 Follow-up (EOS) for Participants With Non-albicans Candida at Baseline|Success: Clinical response=Cure (s/s of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (f/u culture negative) or Presumed Eradication (f/u culture n/a and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida spp) or Presumed Persistence (f/u culture n/a and clinical outcome= failure).|Week 6 Follow-up (EOS)|MITT; N=number of participants in the MITT population where the pathogen isolated at baseline was a Candida spp. other than Candida albicans (participants with missing outcome values were excluded from the analysis).||participants|||Number
776655|NCT00768066|Secondary|Ectopic Tissue Formation.||12 months post-catheterization|||participants|||Number
743234|NCT00496197|Secondary|Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at Week 2 Follow-up for Participants With Non-albicans Candida at Baseline|Success: Clinical response=Cure (s/s of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (f/u culture negative) or Presumed Eradication (f/u culture n/a and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida spp) or Presumed Persistence (f/u culture n/a and clinical outcome= failure).|Week 2 Follow-up|MITT; N=number of participants in the MITT population where the pathogen isolated at baseline was a Candida spp. other than Candida albicans (participants with missing outcome values were excluded from the analysis).||participants|||Number
743235|NCT00496197|Secondary|Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at EOIV for Participants With Non-albicans Candida at Baseline|Success: Clinical response=Cure (s/s of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (f/u culture negative) or Presumed Eradication (f/u culture n/a and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida spp) or Presumed Persistence (f/u culture n/a and clinical outcome= failure).|End of Intravenous treatment (Day 5 up to Day 28)|MITT; N=number of participants in the MITT population where the pathogen isolated at baseline was a Candida spp. other than Candida albicans (participants with missing outcome values were excluded from the analysis).||participants|||Number
743236|NCT00496197|Secondary|Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at EOT for Participants With Non-albicans Candida at Baseline|Success: Clinical response=Cure (s/s of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (f/u culture negative) or Presumed Eradication (f/u culture n/a and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida spp) or Presumed Persistence (f/u culture n/a and clinical outcome= failure).|End of Treatment (Day 5 up to Day 42)|MITT; N=number of participants in the MITT population where the pathogen isolated at baseline was a Candida spp. other than Candida albicans (participants with missing outcome values were excluded from the analysis).||participants|||Number
743237|NCT00496197|Secondary|Number of Participants With Sustained (Continued) Microbiological Response at Week 6 Follow-up (EOS)|Microbiological Success=Eradication: negative culture for baseline Candida spp or Presumed Eradication: f/u culture n/a and clinical outcome defined as success (cure or improvement); Microbiological Failure=Persistence: positive culture for at least 1 baseline Candida spp or Presumed Persistence: f/u culture n/a and clinical outcome defined as failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida).|Week 6 Follow-up (EOS)|MITT; N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis).||participants|||Number
743238|NCT00496197|Secondary|Number of Participants With Sustained (Continued) Clinical Response at Week 6 Follow-up (EOS)|Clinical Success=Cure: resolution of Candida s/s or Improvement: significant but incomplete resolution of s/s; Clinical Failure: at least 3 doses Anidulafungin with no significant improvement in s/s or death due to Candida.|Week 6 follow-up (EOS)|MITT; N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis).||participants|||Number
743239|NCT00496197|Secondary|Number of Participants With Sustained (Continued) Global Response of Success or Failure (Based on Clinical and Microbiological Response) at Week 6 Follow-up (End of Study [EOS])|Success: Clinical response=Cure (s/s of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (f/u culture negative) or Presumed Eradication (f/u culture n/a and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida spp) or Presumed Persistence (f/u culture n/a and clinical outcome= failure).|Week 6 Follow-up (EOS)|MITT; N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis).||participants|||Number
743240|NCT00496197|Secondary|Number of Participants With Sustained (Continued) Microbiological Response at Week 2 Follow-up|Microbiological Success=Eradication: negative culture for baseline Candida spp or Presumed Eradication: f/u culture n/a and clinical outcome defined as success (cure or improvement); Microbiological Failure=Persistence: positive culture for at least 1 baseline Candida spp or Presumed Persistence: f/u culture n/a and clinical outcome defined as failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida).|Week 2 Follow-up|MITT; N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis).||participants|||Number
743241|NCT00496197|Secondary|Number of Participants With Sustained (Continued) Clinical Response at Week 2 Follow-up|Clinical Success=Cure: resolution of Candida s/s or Improvement: significant but incomplete resolution of s/s; Clinical Failure: at least 3 doses Anidulafungin with no significant improvement in s/s or death due to Candida.|Week 2 follow-up|MITT; N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis).||participants|||Number
743242|NCT00496197|Secondary|Number of Participants With Sustained (Continued) Global Response of Success or Failure (Based on Clinical and Microbiological Response) at Week 2 Follow-up|Success: Clinical response=Cure (s/s of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (f/u culture negative) or Presumed Eradication (f/u culture n/a and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida spp) or Presumed Persistence (f/u culture n/a and clinical outcome= failure).|Week 2 Follow-up|MITT; N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis).||participants|||Number
743343|NCT00496782|Secondary|Number of Subjects With Susceptibility to Maraviroc|Phenotypic susceptibility to maraviroc|Screening (Day -21 to 0), Day 14, Week 24|Study was canceled with only 16 subjects of 60 subjects required to enroll.||Participants|||Number
743243|NCT00496197|Secondary|Number of Participants With Microbiological Response at EOIV|Microbiological Success=Eradication: negative culture for baseline Candida spp or Presumed Eradication: f/u culture n/a and clinical outcome defined as success (cure or improvement); Microbiological Failure=Persistence: positive culture for at least 1 baseline Candida spp or Presumed Persistence: f/u culture n/a and clinical outcome defined as failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida).|End of Intravenous treatment (Day 5 up to Day 28)|MITT; N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis).||participants|||Number
743244|NCT00496197|Secondary|Number of Participants With Clinical Response at EOIV|Clinical Success=Cure: resolution of Candida s/s or Improvement: significant but incomplete resolution of s/s; Clinical Failure: at least 3 doses Anidulafungin with no significant improvement in s/s or death due to Candida.|End of Intravenous treatment (Day 5 up to Day 28)|MITT; N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis).||participants|||Number
743245|NCT00496197|Secondary|Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at End of Intravenous Treatment (EOIV)|Success: Clinical response=Cure (s/s of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (f/u culture negative) or Presumed Eradication (f/u culture n/a and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida spp) or Presumed Persistence (f/u culture n/a and clinical outcome= failure).|End of Intravenous treatment (Day 5 up to Day 28)|MITT; N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis).||participants|||Number
743246|NCT00496197|Secondary|Number of Participants With Microbiological Response at EOT|Microbiological Success=Eradication: negative culture for baseline Candida spp or Presumed Eradication: f/u culture n/a and clinical outcome defined as success (cure or improvement); Microbiological Failure=Persistence: positive culture for at least 1 baseline Candida spp or Presumed Persistence: f/u culture n/a and clinical outcome defined as failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida).|End of Treatment (Day 5 up to Day 42)|MITT; N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis).||participants|||Number
743247|NCT00496197|Secondary|Number of Participants With Clinical Response at EOT|Clinical Success=Cure: resolution of Candida s/s or Improvement: significant but incomplete resolution of s/s; Clinical Failure: at least 3 doses Anidulafungin with no significant improvement in s/s or death due to Candida.|End of Treatment (Day 5 up to Day 42)|MITT; N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis).||participants|||Number
743248|NCT00496197|Primary|Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at End of Treatment (EOT)|Success: Clinical response=Cure (no signs, symptoms [s/s] of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (follow up [f/u] culture negative) or Presumed Eradication (f/u culture not available [n/a] and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida species [spp]) or Presumed Persistence (f/u culture n/a and clinical outcome= failure).|End of Treatment (Day 5 up to Day 42)|Modified Intent to Treat population (MITT): includes all participants who received at least 1 dose of study medication and with a positive baseline culture for a Candida spp. N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis).||participants|||Number
743249|NCT00496262|Secondary|Classical In Vivo Recovery (IVR)|Maximum fibrinogen activity increase in plasma times plasma volume per mg/kg dose|Pre-infusion to 4 hours post-infusion|The pharmacokinetic analysis population (PK PP) included all subjects who received >90% of the infusion and who also had sufficient data for a reliable PK analysis (n=14).||% of expected increase in fibrinogen||Full Range|Median
743250|NCT00496262|Secondary|Incremental In Vivo Recovery (IVR)|Maximum fibrinogen activity increase in plasma per mg/kg dosed|Pre-infusion to 4 hours post-infusion|The pharmacokinetic analysis population (PK PP) included all subjects who received >90% of the infusion and who also had sufficient data for a reliable PK analysis (n=14).||mg/dL increase per mg/kg body weight||Full Range|Median
743251|NCT00496262|Secondary|Volume of Distribution at Steady State (Vss)|Vss for fibrinogen activity was determined from samples taken at 11 timepoints during the specified time frame.|Pre-infusion to 13 days post-infusion|The pharmacokinetic analysis population (PK PP) included all subjects who received >90% of the infusion and who also had sufficient data for a reliable PK analysis (n=14).||mL/kg||Standard Deviation|Mean
743252|NCT00496262|Secondary|Mean Residence Time (MRT)|MRT for fibrinogen activity was determined from samples taken at 12 timepoints during the specified time frame.|Pre-infusion to 13 days post-infusion|The pharmacokinetic analysis population (PK PP) included all subjects who received >90% of the infusion and who also had sufficient data for a reliable PK analysis (n=14).||hours||Standard Deviation|Mean
743253|NCT00496262|Secondary|Clearance (Cl)|Cl for fibrinogen activity was determined from samples taken at 12 timepoints during the specified time frame.|Pre-infusion to 13 days post-infusion|The pharmacokinetic analysis population (PK PP) included all subjects who received >90% of the infusion and who also had sufficient data for a reliable PK analysis (n=14).||mL/hour/kg||Standard Deviation|Mean
743254|NCT00496262|Secondary|Area Under the Concentration-time Curve (AUC) Standardized for 70 mg/kg Body Weight Dose|AUC for fibrinogen activity was determined from samples taken at 12 timepoints during the specified time frame.|Pre-infusion to 13 days post-infusion|The pharmacokinetic analysis population (PK PP) included all subjects who received >90% of the infusion and who also had sufficient data for a reliable PK analysis (n=14).||hour*mg/mL||Standard Deviation|Mean
743255|NCT00496262|Secondary|Maximum Concentration (Cmax)|Cmax for fibrinogen activity was determined from samples taken at 12 timepoints during the specified time frame.|Pre-infusion to 13 days post-infusion|The pharmacokinetic analysis population (PK PP) included all subjects who received >90% of the infusion and who also had sufficient data for a reliable PK analysis (n=14).||g/L||Standard Deviation|Mean
747600|NCT00530842|Secondary|Static Lung Volumes|Post-dose IC (Inspiratory Capacity) after 4 weeks (measured by bodyphlethysmography)|4 weeks|FAS using imputed values||Litres||Standard Error|Mean
743257|NCT00496262|Primary|Maximum Clot Firmness (MCF)|MCF is a functional parameter that depends on the activation of coagulation, the fibrinogen content of the sample (in plasma), and the polymerization and crosslinking of the fibrin network. MCF was determined by rotational thromboelastometry (ROTEM) testing.|Pre-infusion and 1 hour post-infusion|All subjects in the intention to treat (ITT) population. The ITT population included all subjects who received any portion of any infusion of human fibrinogen concentrate. (Note: 2 subjects in the ITT population had missing MCF data; the change from baseline MCF was entered as 0.0 for these subjects.)||millimeters||Standard Deviation|Mean
743258|NCT00496340|Secondary|Percentage of Participants With Overall Survival (OS)|OS at 2 years post-transplant. OS, defined as time from day of hematopoietic cell infusion to death from any cause.|2 years post-transplant|All participants||percentage of participants||95% Confidence Interval|Number
743259|NCT00496340|Secondary|Percentage of Participants With Progression Free Survival (PFS)|PFS at 2 years post-transplant. PFS, defined as time from day of hematopoietic cell infusion to disease relapse. Relapsed disease: Disease was in complete remission post-transplant but returned (e.g., >5% blast in bone marrow or any peripheral blasts).|2 years post-transplant|All participants||percentage of participants||95% Confidence Interval|Number
743260|NCT00496340|Secondary|Incidence of Graft Versus Host Disease (GVHD)|"By day +100, the cumulative incidence of GVHD, acute of grades 2-4, and 3-4.
At 2 years, the cumulative incidence of chronic GVHD of any severity according to National Institutes of Health (NIH) consensus criteria. Diagnosis of chronic GVHD requires the presence of at least one diagnostic clinical sign of chronic GVHD or the presence of at least one distinctive manifestation confirmed by pertinent biopsy or other relevant tests in the same or another organ. Furthermore, other possible diagnoses for clinical symptoms must be excluded. No time limit is set for the diagnosis of chronic GVHD.
At 2 years, the cumulative incidence of moderate/severe chronic GVHD."|Up to 2 years post-transplant|All participants||percentage of participants||95% Confidence Interval|Number
743261|NCT00496340|Secondary|Time to Incidence of Graft Versus Host Disease (GVHD)|"The median time from allo-HCT to the initiation of tacrolimus (TAC) taper.
The median time to onset of acute GVHD (aGVHD). Clinical manifestations of acute GVHD include a classic maculopapular rash; persistent nausea and/or emesis; abdominal cramps with diarrhea; and a rising serum bilirubin concentration."|Up to 2 years post-transplant|All participants||days||95% Confidence Interval|Median
743262|NCT00496340|Secondary|Incidence of Infections|Infections: Incidence of infections (opportunistic and non-opportunistic) following conditioning.|Up to 2 years post-transplant|All participants||participants|||Number
743263|NCT00496340|Secondary|Non-relapse Mortality Rate (NRM)|The cumulative incidence of NRM after allo-HCT.|Up to 2 years post-transplant|All participants||percentage of participants||95% Confidence Interval|Number
743264|NCT00496340|Secondary|Rate of T-cell (CD3+) and Myeloid (CD33+) Chimerism by Day +100|Median Percentage of Donor Cells in Study Population (Chimerism).|100 days post-transplant|Participants with bone marrow chimerism data available at time of analysis.||percentage of cells||95% Confidence Interval|Median
743265|NCT00496340|Secondary|Rate of T-cell (CD3+) and Myeloid (CD33+) Chimerism by Day +28|Median Percentage of Donor Cells in Study Population (Chimerism).|28 days post-transplant|Participants with bone marrow chimerism data available at time of analysis.||percentage of cells||95% Confidence Interval|Median
743266|NCT00496340|Secondary|Cumulative Incidence of Hematopoietic Cell Engraftment|Hematologic engraftment: defined as time to achieve an absolute neutrophil count (ANC) >/= 500/µl for 3 consecutive days or a platelet count of >/= 20,000//µl without the need for platelet support.|28 days post-transplant|All participants||percentage of participants||95% Confidence Interval|Number
743267|NCT00496340|Primary|Incidence of Greater Than or Equal to 50% Donor Chimerism|The primary endpoint was achievement of >/= 50% donor chimerism in CD3+ peripheral blood lymphocytes by day +28 (± 7) after allogeneic hematopoietic cell transplantation (allo-HCT).|28 days post-transplant|All participants||percentage of participants|||Number
743268|NCT00496366|Secondary|-Determine the Clinical Benefit Rate (Complete Response, Partial Response, or Stable Disease for at Least 6 Months) of Capecitabine and Lapatinib. -Determine Time to Disease Progression After Treatment With Capecitabine and Lapatinib. -Evaluate Overall||2 years|Study was terminated early and insufficient data was collected to assess this outcome measure.|||||
743269|NCT00496366|Primary|Determine the Response Rate (as Determined by RECIST Criteria) of Capecitabine and Lapatinib as First-line Therapy in Patients With Advanced or Metastatic Breast Cancer That Overexpress HER2.||2 years|Study to was terminated early and insufficient data was collected to assess this outcome measure.|||||
743270|NCT00496379|Secondary|Clinical Benefit Rate.|CBR = CR + PR + SD > 24 weeks in CNS with at least stable non-CNS disease|2 years|all pts who received at least 1 dose of protocol therapy||percentage of participants|||Number
743271|NCT00496379|Secondary|Time to Progression at Any Site.|Time from date of registration until the date of the first documentation of progression or date of death (from any cause),whichever came first, up to 2 years from registration. Progression is defined as either progression in the Central Nervous system (CNS) according to volumetric measurement (Freedman et al. 2011) and /or progression in non-Central Nervous System lesion Measured by RECIST 1.0|2 years|all patients who received at least 1 dose of protocol therapy||months||Full Range|Median
743272|NCT00496379|Secondary|Objective Response Rate in Non-Central Nervous System (CNS) Sites|Non-CNS response rate (according to RECIST 1.0) limited to patients with measurable non-CNS disease|2 years|only included the 8 pts with measurable non-CNS disease at baseline. The 7 pts with non-measurable non-CNS disease at baseline were not included in the denominator for this endpoint||percentage of participants|||Number
743273|NCT00496379|Secondary|Number of Subjects With Adverse Events (Any Grade)|Adverse events per NCI CTCAE|2 years|Study was closed prior to full accrual for reasons detailed in published manuscript||participants|||Number
743274|NCT00496379|Primary|Objective Response Rate in the Central Nervous System (CNS)|Objective response rate is defined as at least a 50 percent reduction in the Central Nervous system target lesion volume compared to the lesion volume at baseline.|2 years|The study was closed prior to full accrual as detailed in the manuscript||percentage of participants||95% Confidence Interval|Number
743275|NCT00496470|Secondary|Serum Vascular Cell Adhesion Molecule-1 (VCAM-1)|Ratio of treatment period mean to run-in value|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Ratio||Inter-Quartile Range|Median
743278|NCT00496470|Secondary|Serum Monocyte Chemoattractant Protein-1 (MCP-1)|Ratio of treatment period mean to run-in value|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Ratio||Inter-Quartile Range|Median
743279|NCT00496470|Secondary|Serum Interleukin 8 (IL-8)|Ratio of treatment period mean to run-in value|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Ratio||Inter-Quartile Range|Median
743280|NCT00496470|Secondary|Serum Interleukin 6 (IL-6)|Ratio of treatment period mean to run-in value|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Ratio||Inter-Quartile Range|Median
743281|NCT00496470|Secondary|Serum High-sensitivity C-reactive Protein (hsCRP)|Ratio of treatment period mean to run-in value|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Ratio||Inter-Quartile Range|Median
743282|NCT00496470|Secondary|Severe COPD Exacerbations|Patients with worsening of COPD leading to treatment with systemic steroids (oral or parenteral), emergency room treatment or hospitalisation|12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Participants|||Number
743283|NCT00496470|Secondary|COPD Symptoms, Cough Score|Daily diary record. Change in average values from run-in to the full treatment period. Symptom scale 0 - 4 (0) None (1) Mild (2) Moderate (3) Marked (4) Severe|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Units on a Scale||Standard Deviation|Mean
743284|NCT00496470|Secondary|COPD Symptoms, Chest Score|Daily diary record. Change in average values from run-in to the full treatment period. Symptom scale 0 - 4 (0) None (1) Mild (2) Moderate (3) Marked (4) Severe|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Units on a Scale||Standard Deviation|Mean
743285|NCT00496470|Secondary|COPD Symptoms, Sleeping Score|Daily diary record. Change in average values from run-in to the full treatment period. Symptom scale 0 - 4 (0) None (1) Mild (2) Moderate (3) Marked (4) Severe|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Units on a Scale||Standard Deviation|Mean
743286|NCT00496470|Secondary|COPD Symptoms, Breathing Score|Daily diary record. Change in average values from run-in to the full treatment period. Symptom scale 0 - 4 (0) None (1) Mild (2) Moderate (3) Marked (4) Severe|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Units on a Scale||Standard Deviation|Mean
743287|NCT00496470|Secondary|Use of Rescue Medication, Total|Daily diary record - Total, 24 hours, during the night, and during the day. Change in average values from run-in to the full treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Inhalations||Standard Deviation|Mean
743288|NCT00496470|Secondary|Use of Rescue Medication, Day|Daily diary record - Day, after morning measurement till evening. Change in average values from run-in to the full treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Inhalations||Standard Deviation|Mean
743289|NCT00496470|Secondary|Use of Rescue Medication, Morning|Daily diary record - Morning, after morning measurement till midday. Change in average values from run-in to the full treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Inhalations||Standard Deviation|Mean
743290|NCT00496470|Secondary|Use of Rescue Medication, Night|Daily diary record - Night, after evening measurement till morning. Change in average values from run-in to the full treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Inhalations||Standard Deviation|Mean
743291|NCT00496470|Secondary|Capacity of Day Living in the Morning (CDLM) Score|"Daily diary record. Change in average values from run-in to the full treatment period.
The CDLM questionnaire is as a questionnaire to report on patient’s ability to carry out each of six different morning activities (score ranging from 0 “not performed” to 1”performed”) and rank the difficulty of performing each of those activities (score ranging from 0 “so difficult that the activity could not be carried out by the patient on their own” to 5 “activity was not at all difficult to carry out”. Total score for each morning activity range from 0-6. Total score for whole CDLM questionnaire range from 0-36."|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Scores on a scale||Standard Deviation|Mean
743292|NCT00496470|Secondary|GCSQ Score, 15 Minutes Post-dose|"Daily diary record. Change in average values from run-in to the full treatment period.
The GCSQ consisted of two questions that required the patient to rate shortness of breath and feelings of chest tightness. The patients recorded their response on a five-point Likert-type scale ranging from 0 (not at all) to 4 (extremely), the total score being calculated as the average score of the two questions."|Baseline to 12 weeks|||Scores on a scale||Standard Deviation|Mean
747601|NCT00530842|Secondary|Static Lung Volumes|Post-dose IC (Inspiratory Capacity) after 8 weeks (measured by bodyphlethysmography)|8 weeks|FAS using imputed values||Litres||Standard Error|Mean
743293|NCT00496470|Secondary|GCSQ Score, 5 Minutes Post-dose|"Daily diary record. Change in average values from run-in to the full treatment period.
The GCSQ consisted of two questions that required the patient to rate shortness of breath and feelings of chest tightness. The patients recorded their response on a five-point Likert-type scale ranging from 0 (not at all) to 4 (extremely), the total score being calculated as the average score of the two questions."|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Scores on a scale||Standard Deviation|Mean
743294|NCT00496470|Secondary|Global Chest Symptoms Questionnaire (GCSQ) Score, Pre-dose|"Daily diary record. Change in average values from run-in to the full treatment period.
The GCSQ consisted of two questions that required the patient to rate shortness of breath and feelings of chest tightness. The patients recorded their response on a five-point Likert-type scale ranging from 0 (not at all) to 4 (extremely), the total score being calculated as the average score of the two questions."|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Scores on a scale||Standard Deviation|Mean
743295|NCT00496470|Secondary|Morning Diary FEV1, 15 Minutes Post-dose|Daily diary record. Change in average values from run-in to the full treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Liters||Standard Deviation|Mean
743296|NCT00496470|Secondary|Morning Diary FEV1, 5 Minutes Post-dose|Daily diary record. Change in average values from run-in to the full treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Liters||Standard Deviation|Mean
743297|NCT00496470|Secondary|Evening Diary FEV1, Pre-dose|Daily diary record. Change in average values from run-in to the full treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Liters||Standard Deviation|Mean
743298|NCT00496470|Secondary|Morning Diary FEV1 Pre-dose|Daily diary record. Change in average values from run-in to the full treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Liters||Standard Deviation|Mean
743299|NCT00496470|Secondary|Morning Peak Expiratory Flow (PEF) 15 Min Post-dose|Daily diary record. Change in average values from run-in to the full treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Liters/minute||Standard Deviation|Mean
743300|NCT00496470|Secondary|Morning Peak Expiratory Flow (PEF) 5 Min Post-dose|Daily diary record. Change in average values from run-in to the full treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Liters/minute||Standard Deviation|Mean
743301|NCT00496470|Secondary|Evening Peak Expiratory Flow (PEF) Pre-dose|Daily diary record. Change in average values from run-in to the full treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Liters/minute||Standard Deviation|Mean
743302|NCT00496470|Secondary|Morning Peak Expiratory Flow (PEF) Pre-dose|Daily diary record. Change in average values from run-in to the full treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Liters/minute||Standard Deviation|Mean
743303|NCT00496470|Secondary|St George's Respiratory Questionnaire for COPD Patients (SGRQ-C) Score|"Change in total score from baseline (Visit 3) to end of treatment (Visit 6, or last available visit).
SGRQ-C is a health related quality of life questionnaire consisting of 40 items divided into two components: 1) symptoms, 2) activity& impacts. The lowest possible value is zero and the highest 100. Higher values correspond to greater impairment in quality of life."|Baseline and 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Score on a scale||Standard Deviation|Mean
743304|NCT00496470|Secondary|Inspiratory Capacity (IC) 60 Minutes Post-dose|Change in the 60 min post-dose IC from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12)|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Liters||Standard Deviation|Mean
743305|NCT00496470|Secondary|Inspiratory Capacity (IC) Pre-dose|Change in the pre-dose IC from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12)|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Liters||Standard Deviation|Mean
743306|NCT00496470|Secondary|Forced Vital Capacity (FVC) 60 Minutes Post-dose|Change in the 60 min post-dose FVC from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Liters||Standard Deviation|Mean
743450|NCT00498186|Secondary|Number of Subjects Who Withdrew From the Trial Due to an Adverse Event During the 5-year Open Label Extension|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|Up to five years|Of the 295 subjects who entered the study, 295 are included in this summary based on the Safety Set (SS).||participants|||Number
743307|NCT00496470|Secondary|Forced Vital Capacity (FVC) 5 Minutes Post-dose|Change in the 5 min post-dose FVC from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12)|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Liters||Standard Deviation|Mean
743308|NCT00496470|Secondary|Forced Vital Capacity (FVC) Pre-dose|Change in the pre-dose FVC from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12)|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Liters||Standard Deviation|Mean
743309|NCT00496470|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 60 Min Post-dose|Change in the 60 min post-dose FEV1from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12)|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Liters||Standard Deviation|Mean
743310|NCT00496470|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 5 Min Post-dose|Change in the 5 min post-dose FEV1from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12)|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Liters||Standard Deviation|Mean
743311|NCT00496470|Primary|Forced Expiratory Volume in 1 Second (FEV1) Pre-dose|Change in the pre-dose FEV1from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12)|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Liters||Standard Deviation|Mean
743312|NCT00496483|Secondary|Safety Evaluation|A combination of deaths, graft failure and biopsy proven acute rejections (BPAR) was used to evaluate the safety.|52 days|All enrolled patients are included in the safety population.||participants|||Number
743313|NCT00496483|Secondary|Tacrolimus Pharmacokinetics (Fluctuation and Swing) Was Measured at Day 7.|Degree og fluctuation and degree of swing was measured as baseline at day 7 (Cmin was measured as part of the primary outcome).|7 days|"48 completed treatment with LCP-Tacro but one patient was excluded from the PP analysis due to inappropriate conversion rate.
Arithmetic mean and standard deviation is given below."||percentage||Standard Deviation|Mean
743314|NCT00496483|Secondary|Tacrolimus Pharmacokinetics (Tmax) Was Measured at Day 7.|Tmax was measured at baseline day 7 (Cmin was measured as part of the primary outcome).|7 days|48 completed treatment with LCP-Tacro but one patient was excluded from the PP analysis due to inappropriate conversion rate. Another patient discontinued before the Day 21 visit.||hour||Full Range|Mean
743315|NCT00496483|Secondary|Tacrolimus Pharmacokinetics (Cmax and Cavg) Was Measured at Day 7.|Cmax and Cavg was measured at baseline day 7 (Cmin was measured as part of the primary outcome).|7 days|"48 completed treatment with LCP-Tacro but one patient was excluded from the PP analysis due to inappropriate conversion rate.
The arithmetic mean and standard deviation is given."||ng/mL||Standard Deviation|Mean
743316|NCT00496483|Primary|Evaluation of Steady State Tacrolimus Exposure (AUC 0-24).|Patients were converted from Prograf to LCP-Tacro on day 7. On day 21, AUC was measured (0 to 24 hours).|21 days|"48 completed treatment with LCP-Tacro but one patient was excluded from the PP analysis due to inappropriate conversion rate. Another patient discontinued before the Day 21 visit.
The arithmetic mean and standard deviation is given."||ng*hr/mL||Standard Deviation|Mean
743317|NCT00496483|Primary|Evaluation of Steady State Tacrolimus Exposure Trough Levels (C24).|Patients were converted from Prograf to LCP-Tacro on day 7. On day 21, a trough level (C24) was measured.|21 days|"48 completed treatment with LCP-Tacro but one patient was excluded from the PP analysis due to inappropriate conversion rate. Another patient discontinued before the Day 21 visit.
The arithmetic mean and standard deviation is given."||ng/mL||Standard Deviation|Mean
743318|NCT00496483|Primary|Evaluation of Steady State Tacrolimus Exposure (AUC 0-24).|Patients had a baseline AUC measured (0 to 24 hours) at day 7 before conversion to LCP-Tacro.|7 days|"48 completed treatment with LCP-Tacro but one patient was excluded from the PP analysis due to inappropriate conversion rate.
The arithmetic mean and standard deviation is given."||ng*hr/mL||Standard Deviation|Mean
743319|NCT00496483|Primary|Evaluation of Steady State Tacrolimus Trough Levels (C24).|Patients had a baseline trough level (C24) measured at day 7 before conversion to LCP-Tacro.|7 days|"48 completed treatment with LCP-Tacro but one patient was excluded from the PP analysis due to inappropriate conversion rate.
The arithmetic mean and standard deviation is given."||ng/mL||Standard Deviation|Mean
743320|NCT00496483|Secondary|Tacrolimus Pharmacokinetics (Fluctuation and Swing) Was Measured at Day 21.|Degree og fluctuation and degree of swing was measured at day 21 (Cmin was measured as part of the primary outcome).|21 days|"48 completed treatment with LCP-Tacro but one patient was excluded from the PP analysis due to inappropriate conversion rate. Another patient discontinued before the Day 21 visit.
Arithmetic mean and standard deviation is given below."||percentage||Standard Deviation|Mean
743321|NCT00496483|Secondary|Tacrolimus Pharmacokinetics (Tmax) Was Measured at Day 21.|Tmax was measured at day 21 (Cmin was measured as part of the primary outcome).|21 days|48 completed treatment with LCP-Tacro but one patient was excluded from the PP analysis due to inappropriate conversion rate. Another patient discontinued before the Day 21 visit.||hour||Full Range|Mean
743322|NCT00496483|Secondary|Tacrolimus Pharmacokinetics (Cmax and Cavg) Was Measured at Day 21.|Cmax and Cavg was measured at day 21 (Cmin was measured as part of the primary outcome).|21 days|"48 completed treatment with LCP-Tacro but one patient was excluded from the PP analysis due to inappropriate conversion rate. Another patient discontinued before the Day 21 visit.
The arithmetic mean and standard deviation is given."||ng/mL||Standard Deviation|Mean
743344|NCT00496782|Secondary|Change in Detectable Resistance (Genotype) and Susceptibility (Phenotype) to Drugs in the Regimen From Screening|Change in detectable resistance (genotype) and susceptibility (phenotype) to drugs in the regimen from Screening|Screening (Day -21), Baseline (Day 0), Day 14 (after addition of MVC to a failing regimen), Week 24, and time of Virologic Failure.|Study was canceled with only 16 subjects of 60 subjects required to enroll.||Gene Sequence|||Number
743323|NCT00496587|Secondary|Objective Response Rate (ORR)|Objective response defined as Complete Response + Partial Response, with response recorded from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Complete Response: The disappearance of all target lesions. Partial Response: >30% decrease in the sum of the longest diameter of target lesions, reference baseline sum longest diameter. Progressive Disease: At least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started, or the appearance of one or more new lesions. Stable Disease: Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, reference smallest sum longest diameter since the treatment started.|12 months or until progression of disease|Four participants were excluded from response analysis due to missing data.||percentage of participants|||Number
743324|NCT00496587|Primary|Time to Treatment Failure (TTF)|Time to treatment failure, TTF, with failure defined as death or disease progression where progression is defined per RECIST criteria as an increase in disease of 20% or more in the sum of longest tumor diameters compared to baseline.|12 months or until progression of disease|Four participants were excluded from response analysis due to missing data.||Months||95% Confidence Interval|Median
743325|NCT00496587|Primary|Progression Free Survival (PFS)|Event or disease-free survival given as progression free survival (PFS) which was defined as the length of time after primary treatment that the participant survives without disease progression. Evaluation of response will follow the Response Evaluation Criteria in Solid Tumors (RECIST) where progression is defined per RECIST criteria as an increase in disease of 20% or more in the sum of longest tumor diameters compared to baseline.|12 months or until progression of disease|One participant was excluded from survival analysis due to missing data.||Months||95% Confidence Interval|Median
743326|NCT00496626|Secondary|Serious Adverse Experiences and Systemic Adverse Experiences Occurring Within 14 Days After Each Vaccination, and Injection-site Complaints Occurring Day 1 Through Day 5 After Each Vaccination|All adverse experiences were collected through 14 days following each vaccination. All participants were requested to record injection-site adverse experiences and monitor the participant's temperature daily on the Vaccination Report Card for Day 1 thereafter for 4 additional calendar days, and record all systemic adverse experiences that occur during the 14-day period after each injection.|For serious adverse experiences and systemic adverse experiences: 14 days follow-up after each dose of vaccination; For injection-site adverse experiences: 5 days follow-up after each dose of vaccination|Safety population, defined as all participants who were vaccinated at least one dose and had safety follow-up data||Participants|||Number
743327|NCT00496626|Secondary|Number of Participants Who Were Seronegative at Baseline and Developed Seropositive at Month 7|"Anti-HPV 6, 11, 16, 18 Seroconversion Rate, i.e., the Number of participants who were seronegative at baseline and developed seropositive at Month 7. Seroconversion for HPV 6, 11, 16, and 18 is defined as achieving an anti-HPV cLIA level of at least 20, 16, 20 and 24 mMU/mL, respectively.
Seroconversion rate = (number of participants with seronegative at baseline and developed seropositive at Month 7)/(number of participants with seronegative at baseline regardless relevant HPV serum status at Month 7). Measure serum anti-HPV 6, 11, 16, 18 titers at Day 1 prior to vaccination and at Month 7"|Collect blood sample for anti-HPV 6, 11, 16, 18 titers testing at Day 1 prior to vaccination and Month 7|Per-protocol population, defined as all participants who received all 3 dose vaccinations within acceptable day ranges, had at least 1 valid serology result after the third injection, and adhered to protocol guidelines. To be included in the immunogenicity analysis for given HPV type, participants must be seronegative to that HPV type at baseline.||Participants|||Number
743328|NCT00496626|Primary|Geometric Mean Titer (GMT) of Anti-HPV 6, 11, 16 , 18 at Day 1 and Month 7 (1 Month After Completion of Administration of a 6-month 3-dose Regimen of Vaccines)|"Measured GMT of anti-HPV 6, 11, 16 and 18 at Day 1 and Month 7 (1 month after completion of administration of a 6-month 3-dose regimen of vaccines). GMT at Day 1 was used to define per-protocol population. Antibody titers were tested with Luminex array.
The numeric values for the Day 1 (Vaccine and Placebo groups) and the Month 7 (Placebo groups) are the threshold of detection for the Luminex array assays. The reported values are all below the lower limit of qualification, ((less than) <7, <8, <11, <10 respectively)"|Collect blood sample for anti-HPV 6, 11, 16, 18 titers testing at Day 1 prior to vaccination, and Month 7|Per-protocol population, defined as all participants who received all 3 dose vaccinations within acceptable day ranges, had at least 1 valid serology result after the third injection, and adhered to protocol guidelines. To be included in the immunogenicity analysis for given HPV type, participants must be seronegative to that HPV type at baseline.||mMU/mL||95% Confidence Interval|Geometric Mean
743329|NCT00496730|Other Pre-specified|Change in Lower Density Lipoprotein Cholesterol From Baseline After 8 Weeks.||Baseline and Week 8|All patient treated(APT) approach which included all patients who had baseline measured right before randomization, have taken the study drug more than once after randomization and have one measurement after the initiation of the treatment.||mg/dL||Standard Deviation|Mean
743330|NCT00496730|Secondary|Number of Patients Attaining LDL-C Goal After 8 Weeks Treatment.|"Number of Patients Attaining LDL-C Goal After 8 Weeks Treatment.
LDL-C goal is based on National Cholesterol Education Program (NCEP) III guideline (LDL-C goals and cutpoints for therapeutic life changes and drug Therapy in different risk)."|Baseline and 8 weeks|All patient treated(APT) approach which included all patients who had baseline measured right before randomization, have taken the study drug more than once after randomization and have one measurement after the initiation of the treatment.||Participants attaining LDL-C goal|||Number
743331|NCT00496730|Primary|Mean Percent Change of Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline After 8 Weeks.||Baseline and 8 Weeks|All patient treated(APT) approach which included all patients who had baseline measured right before randomization, have taken the study drug more than once after randomization and have one measurement after the initiation of the treatment.||Percent of Baseline Value||Standard Deviation|Mean
747602|NCT00530842|Secondary|Static Lung Volumes|Trough IC (Inspiratory Capacity) after 4 weeks (measured by bodyphlethysmography)|4 weeks|FAS using imputed values||Litres||Standard Error|Mean
743341|NCT00496782|Secondary|Correlation of Mutations in gp160 and the V3 Loop and Decreased Susceptibility to Maraviroc||Screening (Day -21 to 0), Day 14, time of virologic failure, Week 24|Study was canceled with only 16 subjects of 60 subjects required to enroll.||Gene Sequence|||Number
743342|NCT00496782|Secondary|Change in Gene Sequence in Gp-160, and the V3 Loop From Screening Visit (Day -21 to 0) to Day 14, Time of Virologic Failure (See Section 6.5.1) and Week 24|Change in gene sequence in gp-160, and the V3 loop from Screening visit (Day -21 to 0) to Day 14, time of virologic failure (See Section 6.5.1) and Week 24|Screening (Day -21 to 0), Day 14, time of virologic failure, and Week 24|Study was canceled with only 16 subjects of 60 subjects required to enroll.||Gene Sequence|||Number
743349|NCT00496782|Primary|Change From Baseline in Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) With R5 & Non-R5 Tropism Results From the Trofile(tm) Assay|Spearman's correlation coefficient to assess percentage of participants achieving HIV-1 RNA with tropism|Baseline, Day 4, 7, 14|Study was canceled: no efficacy data (primary/secondary) was collected per protocol for limited number of patients left in study; only safety data was summarized.||percentage of participants|||Number
743350|NCT00496782|Secondary|Change in Lymphocyte Subset CD4 From Baseline|Calculated average of CD4 at Day 7, 14, 28 and Week 24 minus CD4 at Day 1|Day 1 (Baseline), Day 7, 14, 28 and Weeks 24|Study was canceled with only 16 subjects of 60 subjects required to enroll.||cells/µL||Standard Deviation|Mean
743351|NCT00496782|Secondary|Time to Virologic Failure|For this protocol, virologic failure will be confirmed by a repeat viral load test within 2 weeks of first viral load meeting any of the following criteria: 1. Failing to achieve a reduction in HIV-1 RNA > 0.5 log10 copies/mL from baseline by the second viral load determination (unless the viral load is below level of quantification [LOQ]); 2. Experiencing a > 0.5 log10 increase from nadir in HIV-1 RNA after achieving an HIV-1 RNA reduction from baseline > 0.5 log10 copies/mL; or 3. Experiencing an HIV-1 RNA >1000 copies/mL after having achieved an HIV-1 RNA below LOQ.|Baseline up to Week 24|Study was canceled with only 16 subjects of 60 subjects required to enroll.||Days||Standard Deviation|Median
743352|NCT00496782|Secondary|Subjects With Virologic Failure|For this protocol, virologic failure will be confirmed by a repeat viral load test within 2 weeks of first viral load meeting any of the following criteria: 1. Failing to achieve a reduction in HIV-1 RNA > 0.5 log10 copies/mL from baseline by the second viral load determination (unless the viral load is below level of quantification [LOQ]); 2. Experiencing a > 0.5 log10 increase from nadir in HIV-1 RNA after achieving an HIV-1 RNA reduction from baseline > 0.5 log10 copies/mL; or 3. Experiencing an HIV-1 RNA >1000 copies/mL after having achieved an HIV-1 RNA below LOQ.|Baseline up to Week 24|Study was canceled with only 16 subjects of 60 subjects required to enroll.||participants|||Number
743353|NCT00496782|Secondary|Subjects Achieving HIV-1 RNA <50 Copies/mL|Number of Subjects Achieving HIV-1 RNA <50 Copies/mL at each time point|Days 4, 7, 14, 28, and Weeks 8, 12, 18, and 24|Study was canceled with only 16 subjects of 60 subjects required to enroll.||participants|||Number
743354|NCT00496782|Secondary|Subjects Achieving HIV-1 RNA <400 Copies/mL|Number of Subjects Achieving HIV-1 RNA <400 Copies/mL at each time point|Days 4, 7, 14, 28, and Weeks 8, 12, 18, and 24|Study was canceled with only 16 subjects of 60 subjects required to enroll.||participants|||Number
743355|NCT00496808|Secondary|Mean Percent of Ki-67|Mean percent of Ki-67 (% nuclei stained) at immunohistochemical staining performed for biomarkers. Tissue sections from diagnostic core biopsy tissue that contains DCIS before treatment and from corresponding tissues that contain DCIS from the surgical resection obtained after a single dose of Herceptin.|Before and after single dose of Herceptin approximately 21 days before DCIS surgery, up to 4 weeks|Analysis was per protocol. Twelve evaluable patients were required to characterize the change in proliferation rate after treatment with a single dose of Herceptin (trastuzumab). Those participants who completed Herceptin administration, surgery, and post surgery bio-markers testing were evaluable.||Percentage of Ki-67||Standard Deviation|Mean
743356|NCT00496808|Primary|Number of Participants Achieving Documented Change in Proliferation|Proliferation rate and apoptotic index measured on core biopsy specimen and resection specimen from each participants. To compare Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and CD4+ T-cell response in each participant observed at pre- and post-treatment times, paired analysis was performed using Student’s t-test. Nonparametric Wilcoxon rank sum test was used to compare data between groups.|Before and after single dose of Herceptin approximately 21 days before DCIS surgery, up to 4 weeks|Twelve evaluable patients were required to characterize the change in proliferation rate after treatment with a single dose of Herceptin (trastuzumab). Those participants who completed Herceptin administration, surgery, and post surgery bio-markers testing were evaluable.||Participants|||Number
743357|NCT00496808|Primary|Percent Change in Proliferation as Measured by Ki-67|Percent Change in Proliferation as measured by Ki-67 (% nuclei stained). Comparison of proliferation rates of Her-2/neu overexpressing cells before and after treatment with Herceptin per Participant where absolute change defined as difference of increase/decrease. Proliferation rate evaluated by immunohistochemistry using paraffin-embedded sections and monoclonal antibody for ki-67.|Before and after single dose of Herceptin approximately 21 days before surgery for ductal carcinoma in situ (DCIS), up to 4 weeks||||||
743358|NCT00496834|Secondary|Diastolic Blood Pressure (DBP) Mean Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug||Baseline and 24 weeks|Participants for analysis was modified intention to treat (Number of patients: Losartan group was 88, Carvedilol group was 94) Missing data were imputed by the last observation carried forward (LOCF) technique.||mm Hg||Standard Deviation|Mean
743359|NCT00496834|Secondary|Systolic Blood Pressure (SBP) Mean Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug||Baseline and 24 weeks|Participants for analysis was modified intention to treat (Number of patients: Losartan group was 88, Carvedilol group was 94) Missing data were imputed by the last observation carried forward (LOCF) technique.||mm Hg||Standard Deviation|Mean
743360|NCT00496834|Primary|PWV Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug|Analysis was performed in the per protocol (PP) population which additionally excludes certain protocol violations as described in the analysis plan.|Baseline and 24 Weeks|Participants for analysis was per protocol (Number of patients: Losartan group was 54, Carvedilol group was 67). Missing data were imputed by the last observation carried forward (LOCF) technique. For the primary efficacy endpoints, Per protocol analysis approach was supplementary used.||meters/second||Standard Deviation|Mean
743361|NCT00496834|Primary|Pulse Wave Velocity (PWV) Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug|Analysis was performed in the modified intention to treat (mITT) population.|Baseline and 24 Weeks|Participants for analysis was modified intention to treat (Number of patients: Losartan group was 88, Carvedilol group was 94). Missing data were imputed by the last observation carried forward (LOCF) technique.||meters/second||Standard Deviation|Mean
743362|NCT00496860|Secondary|Immunogenicity of ALT-801|Titer of anti-drug Abs at week 4|24 months|||titer||Standard Error|Mean
743363|NCT00496860|Secondary|ALT-801 Induced Cell-mediated Immune Responses|Number of tumor-responsive (interferon-gamma positive (IFNg+)) immune cells in blood post dosing|24 months|||IFNg spots per million PMBCs||Standard Error|Mean
743364|NCT00496860|Secondary|Clinical Antitumor Response to ALT-801|Number of subjects with a complete response (CR), partial response (PR) or stable disease (SD). CR is defined as disappearance of all tumor lesions selected for measurement. PR is defined as at least 30% decrease in the sum of all tumor lesions selected for measurement. Stable disease is defined as neither sufficient tumor shrinkage to qualify for PR nor sufficient tumor increase to qualify for progressive disease (PD) which is defined as at least 20% increase the sum of the all tumor lesions selected for measurement.|24 months|||participants|||Number
743365|NCT00496860|Primary|The Maximum-tolerated Dose (MTD) of ALT-801|Number of dose limiting toxicities (DLTs). A DLT is a toxicity that results in patient withdrawal from the study as defined in the protocol.|18 months|||events|||Number
743366|NCT00496860|Primary|The Safety and Toxicity of ALT-801 in Patients With Progressive Metastatic Malignancies|Number of serious adverse events per cohort|18 months|||Events|||Number
743367|NCT00496873|Secondary|3-Year Progression-Free Survival|Progression-free survival (PFS) was defined as time from initiation of therapy to progression of disease or death, whichever occurred first. The Kaplan-Meier method was used to estimate PFS.|PFS assessed 7 days prior to every cycle and then every 3 months after off-treatment for one year, every 6 months for second year, then once on third year|Two participants of the 85 enrolled were found to be ineligible following the enrollment and not treated therefore are excluded from outcome analysis. For the 83 eligible participants, five were considered inevaluable for response, but are included as non-responders in an intent-to-treat analysis.||percentage of participants||95% Confidence Interval|Number
743368|NCT00496873|Primary|Number of Participants With Complete Response (CR)/Complete Response Unconfirmed (CRu) With Low-grade Lymphoma (N=83) After 6-9 Cycles of PCR Therapy|Number of participants with response according to the International Working Group (IWG) anatomic criteria for assessing six categories of efficacy response or nonresponse to treatment in non-Hodgkins lymphoma (NHL): complete remission (CR), complete remission/unconfirmed (CRu), partial remission (PR), stable disease (SD), relapsed disease (RD), and progressive disease (PD). Response was assessed after 3, 6, and 9 cycles of therapy.|9 cycles of 21 days, up to 7 months|Two participants of the 85 enrolled were found to be ineligible following the enrollment and not treated therefore are excluded from outcome analysis. For the 83 eligible participants, five were considered inevaluable for response, but are included as non-responders in an intent-to-treat analysis.||participants|||Number
743369|NCT00496873|Primary|Participant Response Rate According to the International Working Group (IWG) Response Criteria for Non Hodgkin's Lymphoma (NHL), Cheson 1999|Number of participants with response out of total treated participants using IWG defined 6 categories based on IWG 1999 Response Criteria for NHL of efficacy response or nonresponse to treatment in non-Hodgkins lymphoma (NHL): complete remission (CR), complete remission/unconfirmed (CRu), partial remission (PR), stable disease (SD). CR: is a complete disappearance of all disease with the exception of nodes. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. PR: is a 50% decrease in the sum of the products of diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions. SD: participants who have achieved less than a PR but who have not developed findings consistent with progressive disease.|Evaluated after treatment in Cycles 3, 6 and 9 (1 Cycle = 21 Days), up to 7 months|Two participants of the 85 enrolled were found to be ineligible following the enrollment and not treated therefore are excluded from outcome analysis. For the 83 eligible participants, five were considered inevaluable for response, but are included as non-responders in an intent-to-treat analysis.||Percentage of Participants|||Number
743377|NCT00497055|Primary|To Measure the Safety and Tolerability of Aripiprazole and Placebo Among Methamphetamine-dependent Individuals, as Determined by the Number of Adverse Clinical Events in the Aripiprazole and Placebo Arms.||Total reported adverse events (throughout study, up to 12 weeks)|||total reported adverse events|||Number
743378|NCT00497055|Primary|To Measure the Acceptability of Aripiprazole and Placebo Among Methamphetamine-dependent Individuals, by Determining (Via Electronic Pill Caps [MEMS or Medication Event Monitoring System]) Medication Adherence to Aripiprazole and Placebo.|To measure the acceptability of aripiprazole and placebo among methamphetamine-dependent individuals, by determining (via electronic pill caps [MEMS or Medication Event Monitoring System]) medication adherence to aripiprazole and placebo. (Percent adherence from MEMS is determined by 100* the number of days where MEMS registered an opening out of the number of days a dose was prescribed for each arm.)|Adherence as determined by MEMS (throughout study, up to 12 weeks)|||percent adherence from MEMS||Standard Deviation|Mean
744997|NCT00511667|Secondary|Time to Maximum Concentration (Tmax) of MK-0941 After Multiple Doses of MK-0941||Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day)|||hours||Full Range|Mean
743379|NCT00497055|Primary|To Test the Hypothesis That Aripiprazole 20 mg Daily Will Reduce Methamphetamine Use Significantly More Than Placebo Among Methamphetamine-dependent Individuals.|To test the hypothesis that aripiprazole 20 mg daily will reduce methamphetamine use significantly more than placebo among methamphetamine-dependent individuals, as determined by the proportion of methamphetamine-positive urines in the aripiprazole versus placebo group.|Final study visit at week 12|||perc of positive urines at final visit|||Number
743380|NCT00497081|Primary|Frequency of Adverse Events Reported||From Baseline (week 0) through Final Visit (week 12)|||Adverse Events Reported|||Number
743381|NCT00497081|Primary|Proportion of Days With Recorded Pill Bottle Opening, as Determined by MEMS.|Proportion of days with recorded pill bottle opening, as determined by MEMS (medication event monitoring system).|Daily, from Baseline (week 0) through Final Visit (week 12)|||Percentage of recorded openings||Standard Deviation|Mean
743382|NCT00497081|Primary|Change in Number of Positive Methamphetamine Urine Tests, Comparing Baseline (Week 0) to Final Visit (Week 12).||Baseline (week 0) and Final Visit (week 12)|||Percentage reduction|||Number
743383|NCT00497146|Secondary|Change in Progression of Left Ventricular Ejection Fraction|Change from baseline to Week 48 in left ventricular ejection fraction.|Baseline to 48 weeks|The intent-to-treat (ITT) population, participants with available data.||percent||Standard Error|Least Squares Mean
743384|NCT00497146|Secondary|Change in Progression of Left Ventricular End-diastolic Volume Index|Change from baseline to Week 48 in left ventricular end-diastolic volume index.|Baseline to 48 weeks|The intent-to-treat (ITT) population, participants with available data.||milliliters/meter^2.7||Standard Error|Least Squares Mean
743385|NCT00497146|Secondary|Change in Progression of Left Ventricular End-systolic Volume Index|Change from baseline to Week 48 in left ventricular end-systolic volume index.|Baseline to 48 weeks|The intent-to-treat (ITT) population, participants with available data.||milliliters/meter^2.7||Standard Error|Least Squares Mean
743386|NCT00497146|Secondary|Change in Progression of Aortic Compliance|Change from baseline to Week 48 in aortic compliance.|Baseline to 48 weeks|The intent-to-treat (ITT) population, participants with available data.||10^-4 cm^2/mmHg||Standard Error|Least Squares Mean
743387|NCT00497146|Secondary|Change in Progression of Thoraco-abdominal Aortic Wall Volume|Change from baseline to Week 48 in thoraco-abdominal aortic wall volume|Baseline to 48 weeks|The intent-to-treat (ITT) population, participants with available data.||milliliters||Standard Error|Least Squares Mean
743388|NCT00497146|Secondary|Change in Progression of Thoraco-abdominal Aortic Plaque Volume|Change from baseline to Week 48 in thoraco-abdominal aortic plaque volume.|Baseline to 48 weeks|The intent-to-treat (ITT) population, participants with available data.||milliliters||Standard Error|Least Squares Mean
743389|NCT00497146|Secondary|Change in High Sensitivity C-reactive Protein (hsCRP)|High sensitivity C-reactive protein (hsCRP) is a biological and inflammatory marker.|Baseline to 48 weeks|The intent-to-treat (ITT) population, participants with available data.||milligrams/liter||Standard Error|Least Squares Mean
743390|NCT00497146|Secondary|Change in B-type Natriuretic Peptide (BNP)|B-type natriuretic peptide (BNP) is a biological and inflammatory marker.|Baseline to 48 weeks|The intent-to-treat (ITT) population, participants with available data.||log nanograms/liter||Standard Error|Least Squares Mean
743391|NCT00497146|Secondary|Change in Troponin-T|Troponin-T is a biological and inflammatory marker.|Baseline to 48 weeks|The intent-to-treat (ITT) population, participants with available data.||micrograms/liter||Standard Error|Least Squares Mean
743392|NCT00497146|Secondary|Change in Interleukin-6 (IL-6)|Interleukin-6 (IL-6) is a biological and inflammatory marker.|Baseline to 48 weeks|The intent-to-treat (ITT) population, participants with available data.||nanograms/liter||Standard Error|Least Squares Mean
743393|NCT00497146|Secondary|Change in Plasma Triiodothyronine (T3)|Plasma triiodothyronine (T3) is a biological and inflammatory marker.|Baseline to 48 weeks|The intent-to-treat (ITT) population, participants with available data.||nanomoles/liter||Standard Error|Least Squares Mean
743394|NCT00497146|Secondary|Change in Left Atrial Volume|Left atrial volume is a measure of diastolic function.|Baseline to 48 weeks|The intent-to-treat (ITT) population, participants with available data.||milliliters||Standard Error|Least Squares Mean
743395|NCT00497146|Secondary|Change in Isovolumetric Relaxation Time (IVRT)|Isovolumetric relaxation time (IVRT) is a measure of diastolic function.|Baseline to 48 weeks|The intent-to-treat (ITT) population, participants with available data.||seconds||Standard Error|Least Squares Mean
743396|NCT00497146|Secondary|Change in E-wave Deceleration Time (DT)|E-wave deceleration time (DT) is a measure of diastolic function.|Baseline to 48 weeks|The intent-to-treat (ITT) population, participants with available data.||seconds||Standard Error|Least Squares Mean
743397|NCT00497146|Secondary|Change in Ratio of Peak E Wave Velocity to Lateral E Wave Velocity (E/E')|The ratio of peak E wave velocity to lateral E wave velocity (E/E') is a measure of diastolic function.|Baseline to 48 weeks|The intent-to-treat (ITT) population, participants with available data.||ratio||Standard Error|Least Squares Mean
743398|NCT00497146|Secondary|Change in Diastolic Mitral Annular Relaxation Velocity (E')|Diastolic mitral annular relaxation velocity (lateral E wave velocity; E') is a measure of diastolic function.|Baseline to 48 weeks|The intent-to-treat (ITT) population, participants with available data.||centimeters/second||Standard Error|Least Squares Mean
743399|NCT00497146|Primary|Change From Baseline in Left Ventricular Mass Index (LVMI) Over 48 Weeks Measured by Cardiac Magnetic Resonance Imaging (MRI)|The Central Cardiac MRI Core Laboratory (CCL) interpreted and analyzed all cardiac MRI data. Left Ventricular Mass (LVM) was normalized to the participant's height by the following equation to obtain LVMI: LVM (grams) divided by height (meters)^2.7.|Baseline to 48 weeks|The analysis was based on the intent-to-treat (ITT) population, defined as all randomized participants who took at least one dose of study drug, with available data.||grams/meter^2.7||Standard Error|Least Squares Mean
743400|NCT00497198|Primary|Change From Baseline in Hemoglobin A1c(HbA1c) at Week 12||12 weeks (baseline to week 12)|Per protocol set; Last observation carried forward||percentage||Standard Error|Mean
743401|NCT00497198|Primary|Hemoglobin A1c (HbA1c) at Baseline||0 weeks|Per protocol set||percentage||Standard Deviation|Mean
743402|NCT00497198|Primary|Change From Baseline in Blood Glucose at Week 12||12 weeks (baseline to week 12)|Per protocol set; Last observation carried forward||mg/dL||Standard Error|Mean
743403|NCT00497198|Primary|Fasting Plasma Glucose at Baseline||0 weeks|Per protocol set||mg/dL||Standard Deviation|Mean
780809|NCT00790647|Secondary|Number of Participants Surviving at 1 Year||one year from transplant|||participants|||Number
743405|NCT00497770|Secondary|Symptom Score Associated With Treatment as Measured by the M.D. Anderson Symptom Inventory - LC(MDASI-LC)|The symptom score assessed: pain, fatigue, nausea, sleep, distress, shortness of breath, memory, appetite, drowsy, dry mouth, sadness, vomiting, numbness, cough, constipation, general activity, mood, work, relationships with other people, walking, enjoyment. Scores for each item range from 0 to 10, where 0 equaled no symptoms and 10 equaled worst possible symptoms. Assessed at baseline and end of treatment.|Baseline and end of treatment (up to 20 cycles [14 months])|The number of participants who had measurements for the subscale at those time points.||participants||Standard Deviation|Mean
743406|NCT00497770|Secondary|Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Operate the Telephone|The daily activities assessed: ability to operate the telephone. OARS-IADL assesses the participant's ability to operate the telephone at baseline and end of treatment. Responses: ability to do the activity without help, some help, unable, or not done (missing). The percent of participants responding in the different levels of functional ability are provided.|beginning and at end of pemetrexed treatment (up to 20 cycles [14 months])|All participants enrolled in the study.||percentage of participants|||Number
743407|NCT00497770|Secondary|Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to do the Act of Shopping|The daily activities assessed: ability to do the act of shopping. OARS-IADL assesses the participant's ability to do the act of shopping at baseline and end of treatment. Responses: ability to do the activity without help, some help, unable, or not done (missing). The percent of participants responding in the different levels of functional ability are provided.|beginning and at end of pemetrexed treatment (up to 20 cycles [14 months])|All participants enrolled in the study.||percentage of participants|||Number
743408|NCT00497770|Secondary|Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Prepare and Take Medications|The daily activities assessed: ability to prepare and take medications. OARS-IADL assesses the participant's ability to prepare and take medications at baseline and end of treatment. Responses: ability to do the activity without help, some help, unable, or not done (missing). The percent of participants responding in the different levels of functional ability are provided.|beginning and at end of pemetrexed treatment (up to 20 cycles [14 months])|All participants enrolled in the study.||percentage of participants|||Number
743409|NCT00497770|Secondary|Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Perform Housework Activities|The daily activities assessed: ability to perform housework activities. OARS-IADL assesses the participant's ability to perform housework activities at baseline and end of treatment. Responses: ability to do the activity without help, some help, unable, or not done (missing). The percent of participants responding in the different levels of functional ability are provided.|beginning and at end of pemetrexed treatment (up to 20 cycles [14 months])|All participants enrolled in the study.||percentage of participants|||Number
743410|NCT00497770|Secondary|Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Handle Personal Finances|The daily activities assessed: ability to handle personal finances. OARS-IADL assesses the participant's ability to handle personal finances at baseline and end of treatment. Responses: ability to do the activity without help, some help, unable, or not done (missing). The percent of participants responding in the different levels of functional ability are provided.|beginning and at end of pemetrexed treatment (up to 20 cycles [14 months])|All participants enrolled in the study.||percentage of participants|||Number
743411|NCT00497770|Secondary|Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Drive or Use Public Transportation|The daily activities assessed: ability to drive or use public transportation. OARS-IADL assesses the participant's ability to drive or use public transportation at baseline and end of treatment. Responses: ability to do the activity without help, some help, unable, or not done (missing). The percent of participants responding in the different levels of functional ability are provided.|beginning and at end of pemetrexed treatment (up to 20 cycles [14 months])|All participants enrolled in the study.||percentage of participants|||Number
743412|NCT00497770|Secondary|Functional Status Based on Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Plan and Prepare Meals|The daily activities assessed: ability to plan and prepare meals. OARS-IADL assesses the participant's ability to plan and prepare meals at baseline and end of treatment. Responses: ability to do the activity without help, some help, unable, or not done (missing). The percent of participants responding in the different levels of functional ability are provided.|beginning and at end of pemetrexed treatment (up to 20 cycles [14 months])|All participants enrolled in the study.||percentage of participants|||Number
743413|NCT00497770|Secondary|Progression Free Survival|Time from start of second line therapy until death, disease progression, or last contact expressed in months. Participants lost to follow-up (that were alive at last contact) were treated as censored using Kaplan-Meier survival analysis method.|baseline to measured progressive disease or death (up to 20 cycles [14 months])|All participants enrolled in the study.||months||95% Confidence Interval|Median
743414|NCT00497770|Secondary|Overall Survival|Overall survival is the duration (months) from enrollment to death. For patients who are alive, overall survival is censored at the last contact.|baseline to date of death from any cause (up to 20 cycles [14 months])|All participants enrolled in the study.||months||95% Confidence Interval|Median
743415|NCT00497770|Primary|Percentage of Participants With a Best Overall Disease Control Response (Disease Control Rate)|Disease Control Rate [DCR] is the percentage of participants with Complete Response (CR), Partial Response (PR), Stable Disease (SD), and SD or Incomplete Response (SI). Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. CR=disappearance of all target lesions; PR=30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD)=20% increase in sum of longest diameter of target lesions; SD=small changes not meeting above criteria; SI=persistence of 1 or more non-target lesion(s) and/or maintenance of tumor marker level above normal limits.|baseline to measured progressive disease (up to 20 cycles [14 months])|"Of the 434 participants enrolled, 50 participants had a response status at the end of pemetrexed treatment indicating Not done/Missing and were not included in this analysis."||percentage of participants|||Number
743416|NCT00497796|Secondary|Plasma Concentration of Maribavir Metabolite VP 44469 During Treatment|For the first 16 subjects to have PK profiling performed, PK sampling was collected at Weeks 2, 6 and 10. For subsequent subjects that have PK profiling performed, PK sampling was collected at Weeks 2 and 6. Samples were collected 12 hours after the morning dose of maribavir. Permissible assessment windows for pharmacokinetic profile sampling purposes were +/- 5 days for each sampling day. Samples for determination of VP 44469 (a metabolite of maribavir) concentration were analyzed by a validated liquid chromatography tandem mass spectrometry (LC/MS/MS) method. For plasma, the minimum detectable concentration for VP 44469 was 0.2 μg/mL.|12 hours post-dose after 2, 6, and 10 weeks of treatment|The PK population, defined as those participants in the ITT-S population from whom plasma samples were drawn, tested for maribavir concentrations, and complete, evaluable PK data were available.||μg/mL||Standard Deviation|Mean
743417|NCT00497796|Secondary|Plasma Concentration of Maribavir During Treatment|For the first 16 subjects to have PK profiling performed, PK sampling was collected at Weeks 2, 6 and 10. For subsequent subjects that have PK profiling performed, PK sampling was collected at Weeks 2 and 6. Samples were collected 12 hours after the morning dose of maribavir. Permissible assessment windows for pharmacokinetic profile sampling purposes were +/- 5 days for each sampling day. Samples for determination of maribavir concentration were analyzed by a validated liquid chromatography tandem mass spectrometry (LC/MS/MS) method. For plasma, the minimum detectable concentration for maribavir was 0.2 μg/mL.|12 hours post-dose after 2, 6, and 10 weeks of treatment|The Pharmacokinetic (PK) population, defined as those participants in the ITT-S population from whom plasma samples were drawn, tested for maribavir concentrations, and complete, evaluable PK data were available.||μg/mL||Standard Deviation|Mean
743418|NCT00497796|Secondary|Percent of Participants With Signs of Bone Marrow Suppression|Bone marrow suppression was assessed by the occurrence of adverse events (AEs) of investigator-reported leukopenia, neutropenia, thrombocytopenia, and pancytopenia; absolute neutrophil count (ANC) <1000/mm3; white blood cell (WBC) count toxicity grade shifts from 0-2 at baseline to a maximum of 3-4 post-baseline; and use of hematopoietic growth factors during the 6 month post-transplant period.|15 weeks|The ITT-S population, defined as all participants who received at least one dose of study drug.||percent of participants|||Number
743419|NCT00497796|Secondary|Number of Participants Who Died Within 6 Months Post-Transplantation||6 months post-transplant|The ITT-S population, defined as all participants who received at least one dose of study drug.||participants|||Number
743420|NCT00497796|Secondary|Number of Participants With Acute Graft Rejection|Rejection was assessed by examining a liver biopsy sample. Diagnosis of graft rejection included a global assessment grade and a rejection activity index score.|26 weeks post-transplant|The ITT-S population, defined as all participants who received at least one dose of study drug.||participants|||Number
743421|NCT00497796|Secondary|Number of Participants With Graft Failure Related Death||Through 6 months post-transplant (From Day 1 to 100 days and 6 months post-transplant)|The ITT-S population, defined as all participants who received at least one dose of study drug.||participants|||Number
743422|NCT00497796|Secondary|Number of Participants With Retransplantation||Through 6 months post-transplant (From Day 1 to 100 days and 6 months post-transplant)|The ITT-Safety (ITT-S) population, defined as all participants who received at least one dose of study drug.||participants|||Number
743423|NCT00497796|Secondary|Number of Participants With CMV Infection or EC-confirmed CMV Disease Within 100 Days Post-Transplantation|Incidence of CMV infection or EC-confirmed CMV disease within the 6-month post-transplant period included in this section were defined (1) with infection assessed by pp65 antigenemia assay; (2) with infection assessed by CMV DNA PCR; (3) with infection assessed by either assay (pp65 antigenemia or CMV DNA PCR); and (4) with infection assessed by initiation of anti-CMV therapy.|100 days post-transplant|The ITT-M population, defined as all randomized subjects who received at least one dose of study drug and had participated in the study for at least 14 weeks or had the potential to receive 14 weeks of therapy by 12-Feb-2009.||participants|||Number
743424|NCT00497796|Secondary|Number of Participants With EC-confirmed CMV Disease Within 100 Days Post-Transplantation|All investigator-determined (protocol-defined) cases of CMV disease (i.e., symptomatic CMV infection or CMV organ disease), were adjudicated by an independent, blinded EC. Symptomatic CMV infection was defined as: CMV infection detected by a positive result from a CMV laboratory assay from at least one central laboratory assay (pp65 antigenemia or CMV DNA polymerase chain reaction [PCR] assay in plasma) and fever >/=38 °C on >/=2 occasions >/=24 hours apart within a 7-day period and at least one of the following: new or increased malaise, two successive measurements of leucopenia (white blood cell [WBC] count <3500/mm3 or a WBC count decrease of 20% if the cell count prior to onset of clinical symptoms was >4000/mm3) >/=24 hours apart, atypical lymphocytosis >/=5%, and thrombocytopenia. CMV organ disease was defined as described by Ljungman et al., 2002.|100 days post-transplant|The ITT-M population, defined as all randomized subjects who received at least one dose of study drug and had participated in the study for at least 14 weeks or had the potential to receive 14 weeks of therapy by 12-Feb-2009.||participants|||Number
743425|NCT00497796|Secondary|Number of Participants With Investigator-determined CMV Disease|Symptomatic CMV infection was defined as: CMV infection detected by a positive result from a CMV laboratory assay from at least one central laboratory assay (pp65 antigenemia or CMV DNA polymerase chain reaction [PCR] assay in plasma) and fever >/=38 °C on >/=2 occasions >/=24 hours apart within a 7-day period and at least one of the following: new or increased malaise, two successive measurements of leucopenia (white blood cell [WBC] count <3500/mm3 or a WBC count decrease of 20% if the cell count prior to onset of clinical symptoms was >4000/mm3) >/=24 hours apart, atypical lymphocytosis >/=5%, and thrombocytopenia. CMV organ disease was defined as described by Ljungman et al., 2002.|Through 6 months post-transplant (Day 1 to 100 days and 6 months post-transplant)|The ITT-M population, defined as all randomized subjects who received at least one dose of study drug and had participated in the study for at least 14 weeks or had the potential to receive 14 weeks of therapy by 12-Feb-2009.||participants|||Number
743426|NCT00497796|Secondary|Time to Onset of CMV Infection or EC-confirmed CMV Disease Within 6 Months Post-Transplantation|All investigator-determined (protocol-defined) cases of CMV disease (i.e., symptomatic CMV infection or CMV organ disease) were adjudicated by an independent, blinded EC. CMV infection was assessed by pp65 Antigenemia or CMV DNA PCR from a central or local lab. CMV organ disease was defined as described by Ljungman et al., 2002.|6 months post-transplant|The ITT-M population, defined as all randomized subjects who received at least one dose of study drug and had participated in the study for at least 14 weeks or had the potential to receive 14 weeks of therapy by 12-Feb-2009.||days||Inter-Quartile Range|Median
743427|NCT00497796|Secondary|Number of Participants With CMV Infection or EC-confirmed CMV Disease Within 6 Months Post-Transplantation|Incidence of CMV infection or EC-confirmed CMV disease within the 6-month post-transplant period included in this section were defined (1) with infection assessed by pp65 antigenemia assay; (2) with infection assessed by CMV DNA PCR; (3) with infection assessed by either assay (pp65 antigenemia or CMV DNA PCR); and (4) with infection assessed by initiation of anti-CMV therapy.|6 months post-transplant|The ITT-M population, defined as all randomized subjects who received at least one dose of study drug and had participated in the study for at least 14 weeks or had the potential to receive 14 weeks of therapy by 12-Feb-2009.||participants|||Number
743428|NCT00497796|Primary|Number of Participants With Endpoint Committee (EC)-Confirmed Cytomegalovirus (CMV) Disease Within 6 Months Post-Transplantation|All investigator-determined (protocol-defined) cases of CMV disease (i.e., symptomatic CMV infection or CMV organ disease), were adjudicated by an independent, blinded EC. Symptomatic CMV infection was defined as: CMV infection detected by a positive result from a CMV laboratory assay from at least one central laboratory assay (pp65 antigenemia or CMV DNA polymerase chain reaction [PCR] assay in plasma) and fever >/=38 °C on >/=2 occasions >/=24 hours apart within a 7-day period and at least one of the following: new or increased malaise, two successive measurements of leucopenia (white blood cell [WBC] count <3500/mm3 or a WBC count decrease of 20% if the cell count prior to onset of clinical symptoms was >4000/mm3) >/=24 hours apart, atypical lymphocytosis >/=5%, and thrombocytopenia. CMV organ disease was defined as described by Ljungman et al., 2002.|6 months post-transplant|The modified Intent-to-Treat (ITT-M) population, defined as all randomized subjects who received at least one dose of study drug and had participated in the study for at least 14 weeks or had the potential to receive 14 weeks of therapy by 12-Feb-2009.||number of participants with event|||Number
743429|NCT00497874|Secondary|Change in Physical Functioning|Physical functioning was assessed using the Physical Functioning, Role Functioning, Health Perceptions, and Pain subscales of the 20-item Medical Outcomes Study Short Form survey (SF-20) (Stewart, Hays, & Ware, Jr., 1988). (SF-20 subscales assessing mental health and social functioning were omitted to get a purer measure of physical functioning). Physical functioning was computed by taking the mean of the four subscales after each was linearly transformed to range from 0-100. The change scores reported here are the difference between the physical functioning scores at baseline and 9 months (i.e., 9 months minus baseline). Change scores range from -100 to +100, with higher positive scores indicating more improvement in physical functioning.|Baseline, 9 months|Multiple imputation||units on a scale||Standard Deviation|Mean
743430|NCT00497874|Secondary|Number of Participants Taking Prescribed Antidepressant Medication (Medication Adherence)|At 9 months follow-up, participants who had been prescribed antidepressant medication were asked if they had started and were still taking it. Participants who were taking their medication or had stopped with their doctor's advice were considered to be adherent.|9 months|Multiple imputation||Participants|||Number
743431|NCT00497874|Secondary|Number Participants Without Major Depression at Baseline Who Experienced the Onset of Major Depression During Follow-up|At baseline and follow-up, Major Depression was assessed using 9-item depression module of the Primary Care Evaluation of Mental Disorders Patient Health Questionnaire—PHQ-9 (Spitzer, Kroenke, & Williams, 1999). In this analysis, Major Depression was assessed among participants not meeting criteria for major depression at baseline.|9 months|Multiple imputation||Participants|||Number
743432|NCT00497874|Secondary|Number of Participants in the Action or Maintenance Stage for Using Effective Methods to Prevent Depression.|Depression prevention was defined as: “Using effective methods to keep depression from occurring, or if it does occur, to keep it as mild and brief as possible.” Effective methods were: 1) controlling negative thinking; 2) engaging in healthy, pleasant activities; 3) practicing stress management; 4) exercising; and 5) getting professional help when needed. Patients who reported that they were not currently practicing depression prevention and had no intention of doing so in the next 6 months were classified in the precontemplation stage; those who intended to practice depression prevention in the next 6 months or next 30 days were classified in the contemplation or preparation stage, respectively; those who had been practicing depression prevention for less than 6 months were in the action stage, and those who had been practicing for more than 6 months were in maintenance. This outcome represents the number of participants in the action or maintenance stage at 9 months follow-up.|9 months|Multiple imputation||Participants|||Number
743433|NCT00497874|Secondary|Number of Participants Exhibiting a Reliable and Clinically Significant Change in Depression Severity|Two statistical criteria (Jacobson & Truax, 1991a; Atkins, Bedics, McGlinchey, & Beauchaine, 2005) were used to define reliable and clinically significant improvement. The first involved selecting a cutoff that represents remission or the absence of symptoms, which was selected to be BDI-II < 9. The second involved selecting a pre-post difference score that represents a statistically reliable change (e.g., how much change—1 point, 5 points, 10 points—is needed to be 95% confident that a real change has occurred, rather than just a chance fluctuation due to the unreliability of the measure?) Using a general formula for calculating reliable change that incorporates test-retest reliability (Jacobson & Truax, 1991b), reliable change for the BDI-II was calculated to be 5.13, and rounded down to 5. Thus, reliable and clinically significant improvement on the BDI-II was defined as a reduction of 5 or more points from baseline to follow-up and a follow-up score < 9.|9 months|Multiple imputation||Participants|||Number
743434|NCT00497874|Primary|Change in Depression Severity|Depression was assessed using the Beck Depression Inventory, 2nd Edition (BDI-II)(Beck, Steer, & Brown, 1996). In this self-report measure, 21 symptoms of depression are rated on a 0-3 scale. Scores for the 21 items are summed to yield a total score ranging from 0 to 63. The change scores reported here are the difference between the total BDI-II scores at baseline and 9 months (i.e., 9 months minus baseline). Change scores range from -63 to +63, with larger negative scores indicating greater reduction in depression.|Baseline, 9 months|Multiple imputation||units on a scale||Standard Deviation|Mean
743435|NCT00498173|Secondary|Change in Pediatric Anxiety Rating Scale, 5-item Total (Open-label Trial)|Since the ABC does not have items which directly assess anxiety, the Pediatric Anxiety Rating Scale (PARS) is administered at week 8 during the study as an exploratory measure. The PARS is a clinician-rated instrument that assesses anxiety symptoms that are commonly associated with social anxiety, separation anxiety, and generalized anxiety disorders. Scaled score ranges form 0-25 with higher scores indicating more severe anxiety symptoms.Change will be determined from the start of the open-label trial to 8 weeks post-start.|8 weeks|Participants randomized to placebo who are not responders at the end of 8 weeks will be treated with atomoxetine for 8 weeks during an open-label trial||units on a scale||95% Confidence Interval|Mean
743436|NCT00498173|Secondary|Change in Pediatric Quality of Life Inventory (Open-label Trial)|Quality of life is assessed with the Pediatric Quality of Life Inventory (PedsQL 4.0). This instrument is well-validated and widely used for measuring health-related quality of life in children and adolescents. It also appears to be a valid instrument for use with children with psychiatric disorders. The Generic Core scales include 23 items. The health related and family functioning scores range from 0 to 100, with higher scores indicating better quality of life. The Family Impact module will be included to assess any change in family functioning. This will be completed at the start of the open-label trial and at the end of 8 weeks. Change will be determined from the start of the open-label trial to 8 weeks post-start.|8 weeks|Participants randomized to placebo who are not responders at the end of 8 weeks will be treated with atomoxetine for 8 weeks during an open-label trial||units on a scale||95% Confidence Interval|Mean
743437|NCT00498173|Secondary|Change in Vineland Adaptive Behavior Scales (VABS) Composite Score (Open-label Trial)|The Vineland Adaptive Behavior Scales, Second Edition (VABS) is used to assess adaptive functioning in four domains: Communication, Daily Living Skills, Socialization, and Motor Skills. This is a well-standardized open-ended interview used to assess the overall functioning of children and adults. This measure is especially important for subjects with PDDs given that their intellectual level is not always comparable to their adaptive functioning. The Vineland Maladaptive Behavior subscales will be included with these measures as these have been shown to be responsive to drug effects in other clinical trials in this population. The composite score represents a standard score (mean = 100 and standard deviation of 15; range = 20-160) on which higher scores indicate a higher level of adaptive functioning. Change will be determined from the start of the open-label phase to 8 weeks|8 weeks|Participants randomized to placebo who are not responders at the end of 8 weeks will be treated with atomoxetine for 8 weeks during an open-label trial||units on a scale||95% Confidence Interval|Mean
743438|NCT00498173|Secondary|Change in Social Responsiveness Scale (SRS) (Open-label Trial)|The Social Responsiveness Scale (SRS) is completed by the parent in order to assess whether additional improvements in social functioning occur with atomoxetine, as observed in our pilot study. This 65-item questionnaire will be completed at baseline and at the end of 8 weeks. The SRS is a standardized measure of the core symptoms of autism. Each item is scored on a 4-point Likert scale. The score of each item is summed to create a total score. Total score results as follows: 0-62: within normal limits; 63-79 mild range of impairment; 80-108: moderate range of impairment; 109-149: severe range of impairment. This 65-item questionnaire will be completed at the start of and at the end of 8 weeks of the open-label trial.|8 weeks|Participants randomized to placebo who are not responders at the end of 8 weeks will be treated with atomoxetine for 8 weeks during an open-label trial||units on a scale||95% Confidence Interval|Mean
743439|NCT00498173|Secondary|Change in Aberrant Behavior Checklist (ABC) (Open-label Trial)|The Aberrant Behavior Checklist (ABC) is a 58-item questionnaire with 5 subscales derived by factor analysis: Irritability, Social Withdrawal, Stereotypy, Hyperactivity, and Inappropriate. It has been extensively used in psychopharmacological studies of autism and assesses many symptoms that are either central to autism (Social Withdrawal, Stereotypy, and Inappropriate Speech) or frequently a target of treatment Irritability). Each item of the 58-item scale is scored on a 4-point scale (0=never a problem to 3=severe problem). The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. The range of scores per subscale are: Social Withdrawal/Lethargy 0-48; Stereotypy 0-21; Irritability 0-45; Hyperactivity 0-48; Inappropriate Speech 0-12. Parent ratings occur every 2 weeks during the study. Change will be determined from the start of the open-label trial to 8 weeks post-start.|8 weeks|Placebo-treated subjects that don’t respond to placebo will be offered an 8-week open-label trial of atomoxetine, and the open-label extension will be a continuation phase for those subjects that respond to 8 weeks of atomoxetine during the double-blind phase.||units on a scale||95% Confidence Interval|Mean
743440|NCT00498173|Secondary|Change in ADHD Rating Scale (ADHDRS)-Home Version Inattention and Hyperactivity Scores (Open-label Trial)|The ADHD Rating Scale (ADHD-RS) is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder with established reliability, validity and sensitivity to change. The ADHD-RS-IV is investigator-administered biweekly during the 8-week open-label phase of the study. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. Results from this rating scale alone should not be used to make a diagnosis. The score fro each subscale ranges from 0-27, with a higher score indicating greater severity. Change will be determined from the start of the open-label trial to 8 weeks post-start.|8 weeks|Participants randomized to placebo who are not responders at the end of 8 weeks will be treated with atomoxetine for 8 weeks during an open-label trial||units on a scale||95% Confidence Interval|Mean
743441|NCT00498173|Secondary|Change in ADHD Rating Scale (ADHDRS)-Home Version Total Score (Open-label Trial)|The ADHD Rating Scale (ADHD-RS) is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder with established reliability, validity and sensitivity to change. The ADHD-RS-IV is investigator-administered biweekly during the 8-week double-blind, placebo-controlled phase of the study. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. Results from this rating scale alone should not be used to make a diagnosis. The total score can range form 0 to 54, with a higher score indicating greater severity. Change will be determined from the start of the open-label trial to 8 weeks post-start.|8 weeks|Participants randomized to placebo who are not responders at the end of 8 weeks will be treated with atomoxetine for 8 weeks during an open-label trial||units on a scale||95% Confidence Interval|Mean
743449|NCT00498173|Primary|ADHD Rating Scale (ADHDRS)-Home Version Total Score (Randomized Phase)|The ADHD Rating Scale (ADHD-RS) is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder with established reliability, validity and sensitivity to change. The ADHD-RS-IV is investigator-administered biweekly during the 8-week double-blind, placebo-controlled phase of the study. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. Results from this rating scale alone should not be used to make a diagnosis. The total score can range form 0 to 54, with a higher score indicating greater severity. Estimates are adjusted for baseline score, study stratum, and site, which were set at their sample means.|8 weeks|Two participants from the Atomoxetine arm, and one participant from the Placebo arm did not have post-baseline measures.||units on a scale||95% Confidence Interval|Mean
743442|NCT00498173|Secondary|Odds of Clinical Global Impression-Improvement Scale, Very Much or Much Improved (1 or 2) (Randomized Phase)|The Clinical Global Impressions Global Improvement (CGI-I) is designed to take into account all factors to arrive at an assessment of response to treatment. The CGI-I scale ranges from 1 to 7 (1=very much improved; 2= much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse), with lower scores indicating improvement (1=very much improved and 2=much improved). Participants with a CGI-I score of 1 or 2 were classified as improved. Odds of improvement at 8 weeks were estimated using a repeated measures logistic regression model adjusting for baseline severity, study stratum, and site. The CGI-I was administered biweekly during the study. The CGI was focused on the target symptoms of inattention, hyperactivity, and impulsivity.|8 weeks|Two participants from the Atomoxetine arm, and one participant from the Placebo arm did not have post-baseline measures.||odds of improvement||95% Confidence Interval|Number
743443|NCT00498173|Secondary|Pediatric Anxiety Rating Scale, 5-Item Total (Randomized Phase)|Since the ABC does not have items which directly assess anxiety, the Pediatric Anxiety Rating Scale (PARS) is administered at week 8 during the study as an exploratory measure. The PARS is a clinician-rated instrument that assesses anxiety symptoms that are commonly associated with social anxiety, separation anxiety, and generalized anxiety disorders. Scaled score ranges form 0-25 with higher scores indicating more severe anxiety symptoms. Estimates are adjusted for baseline score, study stratum, and site, which were set at their sample means.|8 weeks|Four participants from the Atomoxetine arm, and two participants from the Placebo arm did not have post-baseline measures.||units on a scale||95% Confidence Interval|Mean
743444|NCT00498173|Secondary|Pediatric Quality of Life Inventory (Randomized Phase)|Quality of life is assessed with the Pediatric Quality of Life Inventory (PedsQL 4.0). This instrument is well-validated and widely used for measuring health-related quality of life in children and adolescents. It also appears to be a valid instrument for use with children with psychiatric disorders. The Generic Core scales include 23 items. The health related and family functioning scores range from 0 to 100, with higher scores indicating better quality of life. The Family Impact module will be included to assess any change in family functioning. This will be completed at baseline and at the end of 8 weeks. Estimates are adjusted for baseline score, study stratum, and site, which were set at their sample means.|8 weeks|Four participants from the Atomoxetine arm, and two participants from the Placebo arm did not have post-baseline measures.||units on a scale||95% Confidence Interval|Mean
743445|NCT00498173|Secondary|Vineland Adaptive Behavior Scales (VABS) Composite Score (Randomized Phase)|The Vineland Adaptive Behavior Scales, Second Edition (VABS) is used to assess adaptive functioning in four domains: Communication, Daily Living Skills, Socialization, and Motor Skills. This is a well-standardized open-ended interview used to assess the overall functioning of children and adults. This measure is especially important for subjects with PDDs given that their intellectual level is not always comparable to their adaptive functioning. The Vineland Maladaptive Behavior subscales will be included with these measures as these have been shown to be responsive to drug effects in other clinical trials in this population. The VABS will be done at baseline and at the end of 8 weeks. The composite score represents a standard score (mean = 100 and standard deviation of 15; range = 20-160) on which higher scores indicate a higher level of adaptive functioning. Estimates are adjusted for baseline score, study stratum, and site, which were set at their sample means.|8 weeks|Four participants from the Atomoxetine arm, and two participants from the Placebo arm did not have post-baseline measures.||units on a scale||95% Confidence Interval|Mean
743446|NCT00498173|Secondary|Social Responsiveness Scale (SRS) (Randomized Phase)|The Social Responsiveness Scale (SRS) is completed by the parent in order to assess whether additional improvements in social functioning occur with atomoxetine, as observed in our pilot study. This 65-item questionnaire will be completed at baseline and at the end of 8 weeks. The SRS is a standardized measure of the core symptoms of autism. Each item is scored on a 4-point Likert scale. The score of each item is summed to create a total score. Total score results as follows: 0-62: within normal limits; 63-79 mild range of impairment; 80-108: moderate range of impairment; 109-149: severe range of impairment. Estimates are adjusted for baseline score, study stratum, and site, which were set at their sample means.|8 weeks|Four participants from the Atomoxetine arm, and two participants from the Placebo arm did not have post-baseline measures.||units on a scale||95% Confidence Interval|Mean
743447|NCT00498173|Secondary|Aberrant Behavior Checklist (ABC) (Randomized Phase)|The Aberrant Behavior Checklist (ABC) is a 58-item questionnaire with 5 subscales derived by factor analysis: Irritability, Social Withdrawal, Stereotypy, Hyperactivity, and Inappropriate. It has been extensively used in psychopharmacological studies of autism and assesses many symptoms that are either central to autism (Social Withdrawal, Stereotypy, and Inappropriate Speech) or frequently a target of treatment (Irritability). Each item of the 58-item scale is scored on a 4-point scale (0=never a problem to 3=severe problem). The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. The range of scores per subscale are: Social Withdrawal/Lethargy 0-48; Stereotypy 0-21; Irritability 0-45; Hyperactivity 0-48; Inappropriate Speech 0-12. Parent ratings occur every 2 weeks during the study. Estimates are adjusted for baseline score, study stratum, and site, which were set at their sample means.|8 weeks|Two participants from the Atomoxetine arm, and one participant from the Placebo arm did not have post-baseline measures.||units on a scale||95% Confidence Interval|Mean
743448|NCT00498173|Secondary|ADHD Rating Scale (ADHDRS)-Home Version Inattention and Hyperactivity Scores (Randomized Phase)|The ADHD Rating Scale (ADHD-RS) is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder with established reliability, validity and sensitivity to change. The ADHD-RS-IV is investigator-administered biweekly during the 8-week double-blind, placebo-controlled phase of the study. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. Results from this rating scale alone should not be used to make a diagnosis. The score for each subscale ranges from 0-27 with a higher score indicating greater severity. Estimates are adjusted for baseline score, study stratum, and site, which were set at their sample means.|8 weeks|Two participants from the Atomoxetine arm, and one participant from the Placebo arm did not have post-baseline measures.||units on a scale||95% Confidence Interval|Mean
743487|NCT00498485|Primary|Self Reported Assessment of Sleep|Subjects were asked to provide their input as to the quality of their sleep over the past week|Assessed at week 6|While data were collected, these data were never analyzed because the study was terminated prematurely by the sponsor and were lost when PI moved from UMDNJ to Beth Israel in NYC in 2008.|||||
743451|NCT00498186|Primary|Number of Subjects With at Least One Adverse Event, as Reported Spontaneously by the Subject or Observed by the Investigator, During the 5-year Open-label Extension.|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|Up to five years|Of the 295 subjects who entered the study, 295 are included in this summary based on the Safety Set (SS).||participants|||Number
743452|NCT00498355|Secondary|The Incidence of Ocular and Non-ocular Adverse Events||Study duration||||||
743453|NCT00498355|Secondary|The Incidence of Uveitis Flares (> 2+ Cells in the Anterior Chamber or Vitreous)||Study duration||||||
743454|NCT00498355|Secondary|The Mean Change in Area of Leakage From Baseline at 3 and 12 Months||3 and 12 months||||||
743455|NCT00498355|Secondary|The Mean Change in Foveal Retinal Thickness From Baseline at 7 Days, and at Months 3, 6, 9, and 12||7 days, and at months 3, 6, 9, and 12||||||
743456|NCT00498355|Secondary|The Mean Change in Best Corrected Visual Acuity From Baseline at 12 Months||12 months from baseline||||||
743457|NCT00498355|Primary|The Mean Change at 3 Months in BSCVA From Baseline|The outcome measure was mean best spectacle-corrected visual acuity (BSCVA). In this study, BSCVA was measured after trial frame manifest refraction, using high-contrast modified Bailey-Lovie (ETDRS) charts at 4 meters. The charts were placed in a retro-illuminated light box equipped with two 20-watt fluorescent tubes. The highest attainable 4-meter visual acuity score is 100 letters.|baseline and 3 months|6 patients completed all assessment points. One patient decided not to continue for nonmedical reasons, but they did complete the baseline, 1-week and 1-month assessment.||letters||Full Range|Mean
743458|NCT00498368|Secondary|Biochemical Marker Immunoglobulin G (IgG) AutoAb at 12 Months||12 months|The number of participants differs from the participant flow because not all participants had the laboratory test done.||U/ml||Standard Deviation|Mean
743459|NCT00498368|Secondary|Biochemical Marker Gd-Immunoglobulin A Subclass 1 (IgA1) at 12 Months||12 months|The number of participants differs from the participant flow because not all participants had the laboratory test done.||U/100ng IgA||Standard Deviation|Mean
743460|NCT00498368|Secondary|Biochemical Marker IgA at 12 Months||12 months|The number of participants differs from the participant flow because not all participants had the laboratory test done.||mg/ml||Standard Deviation|Mean
743461|NCT00498368|Primary|Change in Proteinuria at 12 Months||1 year|The number of participants differs from the participant flow because not all participants had the laboratory test done.||participants|||Number
743462|NCT00498433|Secondary|Part 2: Number of Participants With Reported Any Adverse Events, Serious Adverse Events and Death||98 days|The safety population consisted of all patients who received at least one dose of study drug with at least one post-baseline safety assessment. Patients were analyzed according to treatment received.||Participants|||Number
743463|NCT00498433|Secondary|Part 2: Change From Baseline in Mitochondrial Mass in Subcutaneous Fat and Skeletal Muscle (Tissue Biopsies)||Placebo Baseline (Day 14), Active Treatment (Day 98)|Total 40 completed subjects needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.|||||
743464|NCT00498433|Secondary|Part 2: Change From Baseline in Peripheral Insulin Sensitivity in Response to Insulin Modified Frequently Sampled Intravenous Glucose Test [IM-FSIGT]for Each Tissue (Adipose or Skeletal Muscle)||Placebo Baseline (Day 14), Active Treatment (Day 98)|Total 40 completed subjects needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.|||||
743465|NCT00498433|Primary|Part 2: Plasma Renin Concentration (PRC) Levels During Double Blind Treatment Period||Day 98|Total 40 completed subjects needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.|||||
743466|NCT00498433|Primary|Part 2: Plasma Renin Activity (PRA) Concentration During Double Blind Treatment Period||Day 98|Total 40 completed subjects needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.|||||
743467|NCT00498433|Primary|Part 2: Change From Baseline in Plasma Angiotensin II Levels During Double Blind Treatment Period|Plasma Ang II was measured prior to and 1 hour after the Insulin modified-frequently sampled intravenous glucose tolerance test (IM-FSIGT) during placebo treatment (Days 14) and active treatment(Day 98).|Placebo Baseline (Day 14), Active Treatment (Day 98)|Total 40 completed subjects needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.|||||
743468|NCT00498433|Primary|Part 2: Change From Baseline in Angiotensin II Levels in Interstitial Fluid of Fat and Skeletal Muscle (Microdialysis) During Double Blind Treatment Period|Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method to determine Ang II concentration.|Placebo Baseline (Day 14), Active Treatment (Day 98)|Total 40 completed subjects needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.|||||
743469|NCT00498433|Primary|Part 1: Renin Activity From Plasma During Amlodipine Treatment Period|Plasma renin activity (PRC) was measured by a trapping PRA (tPRA) assay.|Day 98|All patients who received at least one dose of study drug and had at least one post-baseline assessment of pharmacodynamic data were included in the data analysis.||ng/nl/h||95% Confidence Interval|Geometric Mean
743470|NCT00498433|Primary|Part 1: Renin Activity From Plasma During Aliskiren Treatment Period|Plasma Renin activity (PRC) was measured by a trapping PRA (tPRA) assay.|Day 42|All patients who received at least one dose of study drug and had at least one post-baseline assessment of pharmacodynamic data were included in the data analysis.||ng/nl/h||95% Confidence Interval|Geometric Mean
743471|NCT00498433|Primary|Part 1: Renin Concentrations From Plasma During Amlodipine Treatment Period|Renin concentrations from plasma were measured as plasma renin concentration (PRC), prorenin concentration and total renin concentration (renin + prorenin concentration).|Day 98|All patients who received at least one dose of study drug and had at least one post-baseline assessment of pharmacodynamic data were included in the data analysis.||pg/mL||95% Confidence Interval|Geometric Mean
743472|NCT00498433|Primary|Part 1: Renin Concentrations From Plasma During Aliskiren Treatment Period|Renin concentrations from plasma were measured as: plasma renin concentration (PRC), prorenin concentration and total renin concentration (renin + prorenin concentration).|Day 42|All patients who received at least one dose of study drug and had at least one post-baseline assessment of pharmacodynamic data were included in the data analysis.||pg/mL||95% Confidence Interval|Geometric Mean
743473|NCT00498433|Primary|Part 1: Angiotensin II Levels in Plasma During Amlodipine Treatment Period|Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method to determine Ang II concentration.|Day 98|All patients who received at least one dose of study drug and had at least one post-baseline assessment of pharmacodynamic data were included in the data analysis.||fmol/mL||95% Confidence Interval|Geometric Mean
743474|NCT00498433|Primary|Part 1: Angiotensin II Levels in Plasma During Aliskiren Treatment Period|Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method to determine Ang II concentration.|Day 42|All patients who received at least one dose of study drug and had at least one post-baseline assessment of pharmacodynamic data were included in the data analysis.||fmol/mL||95% Confidence Interval|Geometric Mean
743475|NCT00498433|Primary|Part 1: Amlodipine Concentrations From Plasma at the End of Amlodipine Treatment Period|Plasma samples were obtained for measurement of aliskiren or amlodipine concentrations. All blood samples were taken by an indwelling cannula inserted in a forearm vein or direct venipuncture. The plasma samples for drug concentrations analyses were taken on the last day of the amlodipine treatment periods (Day 98).|Day 98|All patients who received at least one dose of study drug and had at least one post-baseline assessment of pharmacokinetics data were included in the data analysis.||ng/mL||Standard Deviation|Mean
743476|NCT00498433|Primary|Part 1: Aliskiren Concentrations From Plasma at the End of Aliskiren Treatment Period|Plasma samples were obtained for measurement of aliskiren or amlodipine concentrations. All blood samples were taken by an indwelling cannula inserted in a forearm vein or direct venipuncture. The plasma samples for drug concentrations analyses were taken on the last day of the aliskiren treatment periods (Day 42).|Day 42|All patients who received at least one dose of study drug and had at least one post-baseline assessment of pharmacokinetics data were included in the data analysis.||ng/mL||Standard Deviation|Mean
743477|NCT00498433|Primary|Part 1: Renin Activity and Concentrations From Adipose and Skeletal Tissues During Aliskiren Treatment Period||Day 42|Renin activity and concentration from adipose tissue and skeletal muscles were all below lower limitation of quantification (LLOQ) at all time points.|||||
743478|NCT00498433|Primary|Part 1: Angiotensin II Levels From Tissue During Aliskiren Treatment Period|Biopsies were taken from abdominal adipose and skeletal muscle tissue to determine Ang II concentration.|Day 42|More than 50% of the biopsy samples over all time points were either below lower limit of quantification (LLOQ) or not received.|||||
743479|NCT00498433|Primary|Part 1: Aliskiren Concentrations From Tissue at the End of Aliskiren Treatment Period|Biopsies were taken from abdominal adipose and skeletal muscle tissue to determine aliskiren concentration. Tissue biopsy samples for drug concentrations analyses were taken on the last day of the aliskiren treatment periods (Day 42).|Day 42|All patients who received at least one dose of study drug and had at least one post-baseline assessment of pharmacokinetics data were included in the data analysis.||ng/g||Standard Deviation|Mean
743480|NCT00498433|Primary|Part 1: Angiotensin II Levels in Interstitial Fluid of Fat and Skeletal Muscle (Microdialysis) During Amlodipine Treatment Period|Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method to determine Ang II concentration.|Day 98|Due to technical limitations, zero flow concentrations could not be derived for Ang II.|||||
743481|NCT00498433|Primary|Part 1: Angiotensin II Levels in Interstitial Fluid of Fat and Skeletal Muscle (Microdialysis) During Aliskiren Treatment Period|Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method to determine Ang II concentration.|Day 42|Due to technical limitations, zero flow concentrations could not be derived for Ang II.|||||
743482|NCT00498433|Secondary|Part 2: Renin Activity and Concentration of Aliskiren and Amlodipine in Fat and Skeletal Muscle Interstitial Fluid||Placebo Baseline (Day 14), Active Treatment (Day 98)|Total 40 completed subjects needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.|||||
743483|NCT00498433|Secondary|Part 2: Change From Baseline in Official Blood Pressure||Placebo Baseline (Day 14), Active Treatment (Day 98)|Total 40 completed subjects needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.|||||
743484|NCT00498433|Secondary|Part 2: Microdialysis Metabolic Analytes in Response to Insulin Modified Frequently Sampled Intravenous Glucose Test [IM-FSIGT]for Each Tissue (Adipose or Skeletal Muscle)||Day 14 and Day 98|Total 40 completed subjects needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.|||||
743485|NCT00498433|Primary|Part 1: Amlodipine Concentrations From Interstitial Fluid (Microdialysis) at the End of Amlodipine Treatment Period|Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method. Interstitial fluid was collected for measurements of drug concentration on the last day of the amlodipine treatment periods (Day 98).|Day 98|Zero flow concentrations from microdialysates could not be derived by linear regression because of missing data due to inadequate sample volumes.|||||
743486|NCT00498433|Primary|Part 1: Aliskiren Concentrations From Interstitial Fluid (Microdialysis)at the End of Aliskiren Treatment Period|Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method. Interstitial fluid was collected for measurements of drug concentrations on the last day of the aliskiren treatment periods (Day 42).|Day 42|All patients who received at least one dose of study drug and had at least one post-baseline assessment of pharmacokinetics (PK)/ pharmacodynamics (PD) data were included in the data analysis.||ng/mL||Standard Deviation|Mean
743539|NCT00486278|Secondary|Haematology: Red Cell Count||screening visit, pre-dose and 12 hours after dosing|Safety analysis set includes all subjects who received at least one dose of the investigational product.||10^12 cells/L||Standard Deviation|Mean
743488|NCT00498485|Primary|Global Assessment of Change|A count was made of subject responses on a Patient Assessment of Change questionnaire where scores went from +2 [much better] thru 0 [no change] to -2 [much worse]|6 weeks|Had we completed the study, the analysis would have been a comparison of counts of those reporting being very much improved across the two treatment conditions||participants|||Number
743489|NCT00485693|Secondary|Number of Participants With Adverse Events or Serious Adverse Events Through 30 Days||Up to 30 days||||||
743490|NCT00485693|Primary|Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) With Activity (NRS-A) Pain Intensity Scores Through Postoperative Day 4|The subject’s pain intensity was to be assessed with activity (NRS-A) after actively flexing the involved knee to the maximum flexion point possible. The subject was asked to respond to the following question: “On a scale of 0 to 10, where 0 = no pain and 10 = worst possible pain, how much pain did you have while bending your knee?”|0 to 96 hours|||Units on a scale*hours||Standard Deviation|Mean
743491|NCT00485732|Secondary|Number of Subjects With Pregnancies and Their Outcome|Total: the total number of pregnancies in a group. The specific outcomes are also listed.|from Day 0 up to Month 7|Analysis was performed on subjects with a pregnancy.||subjects|||Number
743492|NCT00485732|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|Serious adverse events assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Day 0 up to Month 7|||subjects|||Number
743493|NCT00485732|Secondary|Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions|NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes. Medically significant AEs assessed include AEs prompting emergency room visits and physician office visits not related to common illnesses or Serious Adverse Events (SAEs) that are not related to common illnesses.|From Day 0 up to Month 7|||subjects|||Number
743494|NCT00485732|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|"Unsolicited adverse event= Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event."|During the 30-day (Days 0-29) period following each vaccination|||subjects|||Number
743495|NCT00485732|Secondary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed include arthralgia, fatigue, fever, gastrointestinal symptoms, headache, myalgia, rash, and urticaria.|During the 7-day (Days 0-6) period following each vaccination|Analysis was performed on the Total vaccinated cohort on the subjects with available data.||subjects|||Number
743496|NCT00485732|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling at the injection site.|During the 7-day (Days 0-6) period following each vaccination|Analysis was performed on the Total vaccinated cohort on the subjects with available data.||subjects|||Number
743497|NCT00485732|Secondary|Anti-HPV-16 and Anti-HPV-18 Antibody Titres|Titres are given as geometric mean titres (GMTs) calculated on all subjects.|Before vaccination (PRE) and one month post Dose 3 (Month 7)|Analysis was performed on the ATP cohort for immunogenicity.||titre||95% Confidence Interval|Geometric Mean
743498|NCT00485732|Primary|Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies|"Seroconversion is defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination.
Cut-off values were 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies."|One month post Dose 3 (Month 7)|Analysis was performed on initially seronegative subjects from the According-to-Protocol (ATP) cohort for immunogenicity.||subjects|||Number
743499|NCT00485758|Secondary|Percent Change at Week (Wk) 12 Compared to Baseline (Bl) in Triglycerides in Patients With Type 2 Diabetes When Compared to Placebo|after 12 weeks of treatment, to assess the reduction of triglycerides in patients with Type 2 diabetes when compared to placebo|Baseline and 12 Weeks|Full Analysis Set With at Least one Post-Titration Visit Measurement||Percent change at Wk 12 compared to Bl||95% Confidence Interval|Median
743500|NCT00485758|Secondary|Percent Change at Week (Wk) 12 Compared to Baseline (Bl) in High Density Lipoprotein Cholesterol in Patients With Type 2 Diabetes When Compared to Placebo|After 12 weeks of treatment, to assess the increase of high-density lipoprotein cholesterol in patients with Type 2 diabetes when compared to placebo|Baseline and 12 Weeks|Full Analysis Set||Percent change at Wk 12 compared to Bl||95% Confidence Interval|Least Squares Mean
743501|NCT00485758|Primary|Percent Change at Week (Wk) 12 Compared to Baseline (Bl) in Low-density Lipoprotein Cholesterol in Patients With Type 2 Diabetes When Compared to Placebo|After 12 Weeks of treatment, to assess the reduction of low-density lipoprotein cholesterol in patients with Type 2 diabetes when compared to placebo|Baseline and 12 Weeks|Full Analysis Set||Percent change at Wk 12 compared to Bl||95% Confidence Interval|Least Squares Mean
743502|NCT00485836|Secondary|Mean Change From Baseline in the NEI VFQ-25 Distance Activities Subscale Score at Month 6|The NEI VFQ-25 (v. 2000; Interviewer Format) consisted of the base set of 25 questions, plus the optional additional questions (where questions A6, A7, and A8 pertained to the Distance Activities Subscale). Scores ranged from 0 to 100; a higher score represented better functioning.|Baseline and 6 months|Intent to treat (randomized) population; however, patients without a baseline score were excluded from analysis.||Points on the NEI VFQ-25 subscale||Standard Deviation|Mean
743503|NCT00485836|Secondary|Mean Change From Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) Near Activities Subscale Score at Month 6|The NEI VFQ-25 (v. 2000; Interviewer Format) consisted of the base set of 25 questions, plus the optional additional questions (where questions A3, A4, and A5 pertained to the Near Activities Subscale). Scores ranged from 0 to 100; a higher score represented better functioning.|Baseline and 6 months|Intent to treat (randomized) population; however, patients without a baseline score were excluded from analysis.||Points on the NEI VFQ-25 subscale||Standard Deviation|Mean
743504|NCT00485836|Secondary|Mean Absolute Change From Baseline in Central Foveal Thickness at Month 6|A central reading center assessed all OCT images. Central foveal thickness was defined as the center point thickness.|Baseline and 6 months|Intent to treat (randomized) population. Missing values were imputed using the LOCF method.||μm||Standard Deviation|Mean
743505|NCT00485836|Secondary|Percentage of Participants With a Central Foveal Thickness of ≤ 250 μm at Month 6|A central reading center assessed all optical coherence tomography (OCT) images. Central foveal thickness was defined as the center point thickness.|6 months|Intent to treat (randomized) population. Missing values were imputed using the LOCF method.||Percentage of participants||95% Confidence Interval|Number
743506|NCT00485836|Secondary|Percentage of Participants Who Lost < 15 Letters in BCVA Score at Month 6 Compared With Baseline|BCVA score based on the ETDRS visual acuity charts (number of correct letters) and assessed at a starting distance of 4 meters.|Baseline and 6 months|Intent to treat (randomized) population. Missing values were imputed using the LOCF method.||Percentage of participants||95% Confidence Interval|Number
743507|NCT00485836|Secondary|Percentage of Participants Who Gained ≥ 15 Letters in BCVA Score at Month 6 Compared With Baseline|BCVA score based on the ETDRS visual acuity charts (number of correct letters) and assessed at a starting distance of 4 meters.|Baseline and 6 months|Intent to treat (randomized) population. Missing values were imputed using the LOCF method.||Percentage of participants||95% Confidence Interval|Number
743508|NCT00485836|Primary|Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at 6 Months|BCVA score in the study eye was based on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts (number of correct letters) and assessed at a starting distance of 4 meters.|Baseline and 6 months|Intent to treat (randomized) population. Missing values were imputed using the last-observation-carried-forward (LOCF) method.||Units on a scale||Standard Deviation|Mean
743512|NCT00486018|Secondary|Mean Change From Baseline in the NEI VFQ-25 Distance Activities Subscale Score at Month 6|The NEI VFQ-25 (v. 2000; Interviewer Format) consisted of the base set of 25 questions, plus the optional additional questions (where questions A6, A7, and A8 pertained to the Distance Activities Subscale). Scores ranged from 0 to 100; a higher score represented better functioning.|Baseline and 6 months|Intent to treat (randomized) population; however, patients without a baseline score were excluded from analysis.||Points on the NEI-VFQ-25 subscale||Standard Deviation|Mean
743513|NCT00486018|Secondary|Mean Change From Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) Near Activities Subscale Score at Month 6|The NEI VFQ-25 (v. 2000; Interviewer Format) consisted of the base set of 25 questions, plus the optional additional questions (where questions A3, A4, and A5 pertained to the Near Activities Subscale). Scores ranged from 0 to 100; a higher score represented better functioning.|Baseline and 6 months|Intent to treat (randomized) population; however, patients without a baseline score were excluded from analysis.||Points on the NEI VFQ-25 subscale||Standard Deviation|Mean
743514|NCT00486018|Secondary|Mean Absolute Change From Baseline in Central Foveal Thickness at Month 6|A central reading center assessed all OCT images. Central foveal thickness was defined as the center point thickness.|Baseline and 6 months|Intent to treat (randomized) population. Missing values were imputed using the LOCF method.||μm||Standard Deviation|Mean
743515|NCT00486018|Secondary|Percentage of Participants With a Central Foveal Thickness of ≤ 250 μm at Month 6|A central reading center assessed all optical coherence tomography (OCT) images. Central foveal thickness was defined as the center point thickness.|6 months|Intent to treat (randomized) population. Missing values were imputed using the LOCF method.||Percentage of participants||95% Confidence Interval|Number
743516|NCT00486018|Secondary|Percentage of Participants Who Lost < 15 Letters in BCVA Score at Month 6 Compared With Baseline|BCVA score based on the ETDRS visual acuity charts (number of correct letters) and assessed at a starting distance of 4 meters. The percentage of subjects who lost <15 letters will be greater than the percentage of subjects who “gained >=15 letters” as “losing <15 letters” includes both those who gained >=15 letters and those who were “stable” (i.e. lost between 1 and 14 letters, had no change, or gained between 1 and 14 letters).|Baseline and 6 months|Intent to treat (randomized) population. Missing values were imputed using the LOCF method.||Percentage of participants||95% Confidence Interval|Number
743517|NCT00486018|Secondary|Percentage of Participants Who Gained ≥ 15 Letters in BCVA Score at Month 6 Compared With Baseline|BCVA score based on the ETDRS visual acuity charts (number of correct letters) and assessed at a starting distance of 4 meters.|Baseline and 6 months|Intent to treat (randomized) population. Missing values were imputed using the LOCF method.||Percentage of participants||95% Confidence Interval|Number
743518|NCT00486018|Primary|Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at 6 Months|BCVA score in the study eye was based on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts (number of correct letters) and assessed at a starting distance of 4 meters.|Baseline and 6 months|Intent to treat (randomized) population. Missing values were imputed using the last-observation-carried-forward (LOCF) method.||Units on a scale||Standard Deviation|Mean
743519|NCT00486044|Secondary|Changes in Cognitive Performance|"Change in Hopkins Verbal Learning Test Delayed Recall
The Hopkins Verbal Learning Test Delayed Recall score is the raw number of words recalled at Trial 4, adjusted for years of education and age. This is a 12-item word list test."|Baseline and 9 months|1 participant in simvastatin arm with missing data||adjusted words recalled||Standard Deviation|Mean
743520|NCT00486044|Secondary|Change in Inflammatory Markers|Change noted in serum high-sensitivity c-reactive protein|baseline and 9 months|2 participants in the simvastatin arm and 3 participants in the placebo arm had incomplete hs-CRP results||mg/L||Standard Deviation|Mean
743521|NCT00486044|Secondary|Changes in Regional Cerebral Blood Flow on MRI|Mean changes noted in posterior cingulate cortex|baseline and 9 months|Number of participants analyzed represent participants in MRI substudy with readable MRI scans at both baseline and 9 months; 24 and 17 readable MRI scans in simvastatin and placebo arms, respectively. Unusable MRI scans resulted from poor quality images due to technical problems.||mL/100 g/min||Standard Deviation|Mean
743522|NCT00486044|Primary|Change in Cerebrospinal Fluid (CSF) Beta-amyloid-42||baseline and 9 months|1 participant declined follow up CSF collection in simvastatin arm; CSF could not be accessed at month 9 in 1 participant in placebo arm||ng/L||Standard Deviation|Mean
747603|NCT00530842|Secondary|Static Lung Volumes|Trough IC (Inspiratory Capacity) after 8 weeks (measured by bodyphlethysmography)|8 weeks|FAS using imputed values||Litres||Standard Error|Mean
743523|NCT00486226|Secondary|Aneurysm Occlusion|Aneurysm occlusion was assessed using the Raymond Scale (Class 1 - Complete Obliteration / Class 2 - Residual Neck / Class 3 - Residual Aneurysm)|post procedure to 6 months|no data was available for 21 subjects post-procedure and 26 subjects at 6 months follow-up; either because the investigator didn't submit the images or due to poor quality of the submitted images||participants|||Number
743524|NCT00486226|Secondary|Satisfactory Coil Mass Position|Satisfactory coil mass position is defined as VRD maintains coil position within the sac with parent artery patency as defined angiographically|6 months|no data was available for 33 subjects; either because the investigator didn't submit the images or due to poor quality of the submitted images||participants|||Number
743525|NCT00486226|Secondary|Device or Procedure Related Adverse Events (AEs)|Incidence of device or procedure related adverse events during the index procedure and till discharge|index procedure to discharge; an average of 3.8 days|||participants|||Number
743526|NCT00486226|Primary|The Successful Intracranial VRD Placement With Satisfactory Coil Mass Position Without the Occurrence of Any Device and/or Procedure Related Serious Adverse Event (SAE)|"Successful intracranial VRD placement is defined as stable VRD placement with complete coverage of the aneurysm neck and parent artery patency.
Satisfactory coil mass position is defined as VRD maintains coil position within the sac with parent artery patency as defined angiographically"|Start of the procedure to end of the procedure (defined as removal of catheter sheath introducer after the coiling procedure)|||participants||95% Confidence Interval|Number
743527|NCT00486252|Other Pre-specified|Change in Intraocular Presssure (IOP): Baseline to Month 1|Change: IOP at observation minus IOP at baseline. IOP was measured with the non-contact or Goldmann tonometer for a given subject. Three measurements were performed in each eye alternating between eyes, starting with the right eye. The mean of the 3 measurements was used and if both eyes were study eyes, the mean of the 2 eyes was used.|Baseline, Month 1|Full Analysis Set (FAS) included all patients who received at least 1 dose of latanoprost (Xalatan®), had baseline IOP recorded, & at least one postbaseline IOP measure recorded (at either Month 1 or Month 3). No imputation techniques used for missing data; only observed data reported.||mmHg||Standard Deviation|Mean
743528|NCT00486252|Secondary|Categorized Percentage Change in Intraocular Pressure (IOP)|Percentage change=100 times (IOP at observation minus IOP at Baseline) divided by IOP at Baseline. Percentage change in each patient assigned to the following: Increase or no change in IOP (percentage change greater than or equal to 0); Percentage reduction of up to 20% (-20 less than or equal to percentage change < 0); Percentage reduction greater than 20% (percentage change < -20).|Month 1, Month 3|"Full Analysis Set (FAS) included all patients who received at least 1 dose of latanoprost (Xalatan®), had baseline IOP recorded, & at least one postbaseline IOP measure recorded (at either Month 1 or Month 3). No imputation techniques used for missing data; only observed data reported. n=number of participants in each group for that category."||participants|||Number
743529|NCT00486252|Secondary|Percentage Change in Intraocular Pressure (IOP)|Percentage change in IOP calculated as 100 times (IOP at Observation minus IOP at Baseline) divided by IOP at Baseline.|Month 1, Month 3|Full Analysis Set (FAS) included all patients who received at least 1 dose of latanoprost (Xalatan®), had baseline IOP recorded, & at least one postbaseline IOP measure recorded (at either Month 1 or Month 3). No imputation techniques used for missing data; only observed data reported.||percentage change in mmHg||Standard Deviation|Mean
743530|NCT00486252|Primary|Change in Intraocular Pressure (IOP): Baseline to Month 3|Change: IOP at observation minus IOP at baseline. IOP was measured with the non-contact or Goldmann tonometer for a given subject. Three measurements were performed in each eye alternating between the eyes, starting with the right eye. The mean of the 3 measurements was used and if both eyes were study eyes, the mean of the 2 eyes was used.|Baseline, Month 3|"Full Analysis Set (FAS) included all patients who received at least 1 dose of latanoprost (Xalatan®), had baseline IOP recorded, & at least one postbaseline IOP measure recorded (at either Month 1 or Month 3). No imputation techniques used for missing data; only observed data reported. n=number of participants in each group for that category."||mmHg||Standard Deviation|Mean
743531|NCT00486265|Secondary|To Evaluate the Safety and Tolerability of AZD4877 on a Daily x 3 Schedule by Assessment of Adverse Events, Non-hematologic Labs and Vital Signs||Patients were followed for safety from the date of first dose of AZD4877 up to 30-days after the last administration of AZD4877, where possible.||||||
743532|NCT00486265|Secondary|To Assess the Effect of AZD4877 on Rate and Duration of CR, CRi, PR and Overall Response (CR,CRi, or PR)|Marrow response is assessed by modified Cheson criteria for Acute Myelogenous Leukemia (AML). Possible outcomes for marrow response are CR (Complete Remission), CRi (Complete Remission with incomplete blood count recovery), PR (Partial Remission), and treatment failure.|Response is evaluated after a maximum of 2 courses of induction therapy.||||||
743533|NCT00486265|Primary|To Determine the PK Profile of AZD4877 [ Time Frame: Daily x 3 Schedule ]|Maximum plasma concentration, Cmax|PK samples are collected on Days 1, 2, 3, 24 and 48 hours following the end of Day 3 AZD4877 infusion and Day 8.||||||
743534|NCT00486265|Primary|To Assess the Effect of AZD4877 on the Rate of Complete Remission (CR)|Marrow response is assessed by modified Cheson criteria for Acute Myelogenous Leukemia (AML). Possible outcomes for marrow response are CR (Complete Remission), CRi (Complete Remission with incomplete blood count recovery), PR (Partial Remission), and treatment failure.|Response is evaluated after a maximum of 2 courses of induction therapy.|8 of 9 patients in Part B were evaluable for response following a maximum of 2 courses of induction therapy.||Participants|||Number
743535|NCT00486265|Primary|To Identify a Maximum Tolerated Dose (MTD) of AZD4877 by Assessment of the Incidence of Dose-limiting Toxicities (DLTs)|To identify a maximum tolerated dose (MTD) of AZD4877 by assessment of the incidence of dose-limiting toxicities (DLTs)|Dose-limiting toxicities (DLTs) are evaluated during the first induction treatment course administered during the initial 15-day treatment period.||||||
743536|NCT00486278|Secondary|Haematology: Platelet Count||screening visit, pre-dose and 12 hours after dosing|Safety analysis set includes all subjects who received at least one dose of the investigational product.||10^9 cells/L||Standard Deviation|Mean
743537|NCT00486278|Secondary|Haematology: White Cell Count||screening visit, pre-dose and 12 hours after dosing|Safety analysis set includes all subjects who received at least one dose of the investigational product.||10^9 cells/L||Standard Deviation|Mean
743538|NCT00486278|Secondary|Haematology: Packed Cell Volume||screening visit, pre-dose and 12 hours after dosing|Safety analysis set includes all subjects who received at least one dose of the investigational product.||percentage (%)||Standard Deviation|Mean
743543|NCT00486278|Secondary|Immunogenicity (Inhibitor Development)|Immunogenicity was tested by formation of neutralising antibodies towards vatreptacog alfa and/or rFVIIa.|Monitoring of adverse events was performed from start of the trial to approximately 4 weeks after administration of trial product.|Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.||participants|||Number
743544|NCT00486278|Secondary|Pharmakokinetic Parameters Based on FVIIa Activity: Vss (Distribution Volume at Steady State)||0-24 hours after trial product administration|All randomised patients in top 3 dosing tiers 3, 4 and 5 who had pharmacokinetic assessments and completed the trial without violating the protocol in a manner that was judged to affect the pharmacokinetic endpoints were included in the pharmacokinetic analysis set. Some subjects did not contribute for pharmacokinetic analysis.||mL/kg||Full Range|Median
743545|NCT00486278|Secondary|Pharmacokinetic Parameters Based on FVIIa Activity: CL (Total Clearance)||0-24 hours after trial product administration|All randomised patients in top 3 dosing tiers 3, 4 and 5 who had pharmacokinetic assessments and completed the trial without violating the protocol in a manner that was judged to affect the pharmacokinetic endpoints were included in the pharmacokinetic analysis set. Some subjects did not contribute for pharmacokinetic analysis.||mL/h||Full Range|Median
743546|NCT00486278|Secondary|Pharmacokinetic Parameters Based on FVIIa Activity: t½ (Terminal Half-life)||0-24 hours after trial product administration|All randomised patients in top 3 dosing tiers 3, 4 and 5 who had pharmacokinetic assessments and completed the trial without violating the protocol in a manner that was judged to affect the pharmacokinetic endpoints were included in the pharmacokinetic analysis set. Some subjects did not contribute for pharmacokinetic analysis.||hours||Standard Deviation|Mean
743547|NCT00486278|Secondary|Pharmacokinetic Parameters Based on FVIIa Activity: MRT (Mean Residence Time)||0-24 hours after trial product administration|All randomised patients in top 3 dosing tiers 3, 4 and 5 who had pharmacokinetic assessments and completed the trial without violating the protocol in a manner that was judged to affect the pharmacokinetic endpoints were included in the pharmacokinetic analysis set. Some subjects did not contribute for pharmacokinetic analysis.||hours||Standard Deviation|Mean
743548|NCT00486278|Secondary|Pharmacokinetic Parameters Based on FVIIa Activity: AUC(0-inf) (Area Under the Plasma FVIIa Activity-time Curve From Time Zero to Infinity)||0-24 hours after trial product administration|All randomised patients in top 3 dosing tiers 3, 4 and 5 who had pharmacokinetic assessments and completed the trial without violating the protocol in a manner that was judged to affect the pharmacokinetic endpoints were included in the pharmacokinetic analysis set. Some subjects did not contribute for pharmacokinetic analysis.||(IU*h)/mL||Geometric Coefficient of Variation|Geometric Mean
743549|NCT00486278|Secondary|Pharmacokinetic Parameters Based on FVIIa Activity: AUC 0-t (Area Under the Plasma FVIIa Activity-time Curve From Time Zero to the Time (t) )||0-24 hours after trial product administration|All randomised patients in top 3 dosing tiers 3, 4 and 5 who had pharmacokinetic assessments and completed the trial without violating the protocol in a manner that was judged to affect the pharmacokinetic endpoints were included in the pharmacokinetic analysis set. Some subjects did not contribute for pharmacokinetic analysis.||(IU*h)/mL||Geometric Coefficient of Variation|Geometric Mean
743550|NCT00486278|Secondary|Number of Subjects With Need for Additional Haemostatic Agents||within 24 hours after successful control of bleeding episode with trial product|All randomised patients for whom at least one of the efficacy variables is assessed were to be included in the full analysis set (FAS). For the outcome measure 9 subjects did not contribute to the data.||participants|||Number
743551|NCT00486278|Secondary|Cessation of Bleeding: Number of Doses Needed to Control Bleeding||Within 9 hours after first trial product administration or need of additional haemostatic medication within 9 hours after first trial administration additional haemostatic agents required to control bleed (treatment failure)|All randomised patients for whom at least one of the efficacy variables is assessed were to be included in the full analysis set (FAS). For the outcome measure 1 subject did not contribute to the data.||bleeding episodes|||Number
743552|NCT00486278|Secondary|Activated Partial Thromboplastin Time (aPTT)|The aPTT time measured in clinical samples reflects both the effect of the drugs (generation of thrombin and FXa) and the presence of rFVIIa /rFVIIa analogue in the plasma samples causing a dose dependent shortening of the clotting time.|pre-dose - 12 hours after trial product administration|Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.||Sec||Standard Deviation|Mean
743553|NCT00486278|Secondary|F1 + 2 (Prothrombin Fragments 1+2)|Thrombin and F1+2 are formed in equimolar quantities by the enzymatic cleavage of prothrombin (FII), and F1+2 thus indicate that thrombin has been generated.|pre-dose - 12 hours after trial product administration|Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.||pmol/L||Standard Deviation|Mean
743554|NCT00486278|Secondary|Prothrombin Time (PT)|The test measures the clotting time of plasma following the activation of tissue factor (TF also called thromboplastin) and calcium to hypocalcemic plasma. PT was provided in percent based on the measured PT in seconds and related/converted with the relevant standard curve. The percent value was derived based on the hyperbolic relation between PT (sec) and % PT activity.|pre-dose - 12 hours after trial product administration|Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.||percentage (%)||Standard Deviation|Mean
743555|NCT00486278|Secondary|Activated Recombinant Human Factor VII Analogue Activity in the Blood||0-24 hours after trial product administration|All randomised patients in top three dosing tiers 3, 4 and 5 who had pharmacokinetic assessments and completed the trial without violation of the protocol in a manner that was judged to affect the pharmacokinetic endpoints were included in the pharmacokinetic analysis set.||IU/mL||Standard Deviation|Mean
743556|NCT00486278|Primary|Number of Adverse Events (AEs)|Adverse event is defined as any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Monitoring of adverse events was performed from start of the trial to approximately 4 weeks after administration of trial product.|Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.||events|||Number
743557|NCT00486291|Secondary|Absolute Weight Change (kg) From Baseline to Week 28||Baseline to 28 weeks|Intent-to-treat Last-observation-carried-forward (ITT-LOCF)||kg||Standard Error|Least Squares Mean
782877|NCT00814983|Primary|Disease Free Survival||One year|No analysis was performed since the experimental arm was not opened|||||
743560|NCT00486434|Primary|Western Ontario and McMaster Universities Arthritis Index (WOMAC) Function Subscore in the Signal Knee.|WOMAC is a self-administered set of standardized questionnaires to evaluate the condition of patients with osteoarthritis of the knee. The subject marks on a scale (1-100) the degree of difficulty for performing each daily function listed in the questionnaire. 0 is no difficulty (best), 100 is extreme difficulty (worst). The total function sub score for the questions are then calculated. Total possible minimum sub score is 0, maximum is 1700. The final outcome is the absolut change from baseline to 24 months. If the outcome is less that 0 there is improvement (less diffulty).|Change from baseline to 24 months|The number of participants analysed for this outcome is the intent-to-treat (ITT) population. ITT is the number of randomized subjects who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the ITT analysis.||Units on a scale||Inter-Quartile Range|Median
743561|NCT00486434|Primary|Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Subscore in the Signal Knee|WOMAC is a self-administered set of standardized questionnaires to evaluate the condition of patients with osteoarthritis of the knee. The subject marks on a scale (1-100) the pain associated with performing each daily activity listed in the questionnaire. 0 is no pain (best), 100 is extreme pain (Worst). The total function sub score for the questions are then calculated. Total possible minimum sub score is 0, maximum is 500. The final outcome is the absolut change from baseline to 24 months. If the outcome is less that 0 there is improvement (less pain).|Change from baseline to 24 months|The number of participants analysed for this outcome is the intent-to-treat (ITT) population. ITT is the number of randomized subjects who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the ITT analysis.||Units on a scale||Inter-Quartile Range|Median
743562|NCT00486434|Secondary|Changes in Biochemical Markers of Bone & Cartilage Metabolism.Effect on Hand OA Assessed by X-ray & Questionnaire at Baseline and After 24 Months.Disease Progression in the Knee Evaluated by MRI.Nature and # of AEs Monitored Continuously During Study||January 2010||||||
743563|NCT00486434|Primary|Joint Space Width (JSW) in the Medial Tibiofemoral Knee Joint in Signal Knee Measured by X-ray After 24 Months.|The signal knee was chosen prior to randomization based on which knee met the inclusion and exclusion criterias. The JSW is the space measured in mm between the 2 bones in the knee joint and this is assessed by x-ray. The JSW decreases with disease progression. The lower limit for participation in the trial were 2 mm JSW. There were no upper limit as long as inclusion and exclusion criterias were met. The outcome was meassured as a change in JSW from baseline to month 24.|Change from baseline to 24 months|The number of participants analysed for this outcome is the intent-to-treat (ITT) population. ITT is the number of randomized subjects who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the ITT analysis.||mm||Standard Deviation|Mean
743564|NCT00486447|Secondary|Clinical Outcomes - EKG, Laboratory Workup, Changes in Medical Management, Downstream Cardiac Testing, Significant Coronary Interventions, and Major Cardiac Events & Long-term Outcomes (Non-fatal MI and Cardiac-related Death).||1 year outcomes after initial MPS exam|Data were not collected for analysis.|||||
743565|NCT00486447|Primary|Detection of Significant Coronary Artery Disease Using Diagnostic Catheterization for Standard of Truth.|Number of subjects with CT for detection purposes|through study completion, an expected average of 1 year|Data were not collected for analysis.|||||
743566|NCT00486525|Primary|CES-D|"The Center for Epidemiological Studies Depression Scale (CES-D) is a self-report scale designed to measure current symptoms of depression rated on a four-point likert scale.
Scores range from 0-60, with higher scores indicating a higher frequency of depressive symptoms."|Immediately post-treatment and 3 months post-treatment|Any subjects who do not have any measurements post-baseline are excluded from analyses.||units on a scale||Standard Error|Least Squares Mean
743567|NCT00486525|Primary|Vitality, SF-36|"The SF-36's (RAND Health Survey) energy/fatigue (vitality) scale focuses on the frequency of feelings of fatigue over the last month.
Standardized scores on the RAND SF-36 vigor/vitality scale range from 0-100, with higher scores indicating less fatigue."|Immediately post-treatment and 3 months post-treatment|Any subjects who do not have any measurements post-baseline are excluded from analyses.||units on a scale||Standard Error|Least Squares Mean
743568|NCT00486525|Primary|MFSI-SF Fatigue|"The 30-item Multidimensional Fatigue Symptom Inventory-Short form (MFSI-SF) assesses behavioral, cognitive, physical, and affective expressions of fatigue.
Items are rated on a 5-point scale indicating how true each statement was for the respondent during the last week (0=not at all; 4=extremely). The total score represents the sum of the subscales measuring general, physical, emotional, and mental fatigue, minus the vigor scale, providing a possible range of scores from -24 to 96, with higher scores indicating greater fatigue."|Immediately post-treatment and 3 months post-treatment|Any subjects who do not have any measurements post-baseline are excluded from analyses.||units on a scale||Standard Error|Least Squares Mean
743569|NCT00486525|Primary|Stimulated ln (IL-1b)|log-transformed Lipopolysaccharide (LPS) stimulated Interleukin-1 beta (IL-1b)|Immediately post-treatment and 3 months post-treatment|Any subjects who do not have any measurements post-baseline are excluded from analyses.||ln (pg/mL)||Standard Error|Least Squares Mean
743570|NCT00486525|Primary|Stimulated ln (IL-6)|log-transformed Lipopolysaccharide (LPS) stimulated Interleukin-6 (IL-6)|Immediately post-treatment and 3 months post-treatment|Any subjects who do not have any measurements post-baseline are excluded from analyses.||ln (pg/mL)||Standard Error|Least Squares Mean
743571|NCT00486525|Primary|Stimulated ln (TNF-a)|log-transformed Lipopolysaccharide (LPS) stimulated Tumor Necrosis Factor-alpha (TNF-alpha)|Immediately post-treatment and 3 months post-treatment|Any subjects who do not have any measurements post-baseline are excluded from analyses.||ln (pg/mL)||Standard Error|Least Squares Mean
743572|NCT00486642|Other Pre-specified|Survival Rate|Calculated by Kaplan and Meier.|At 1 year|Very little death information is captured for this study so OS analysis was not done.|||||
743573|NCT00486642|Other Pre-specified|Median Survival Time|Calculated by Kaplan and Meier|Up to 1 year after completion of treatment|Very little death information is captured for this study so OS analysis was not done.|||||
743574|NCT00486642|Secondary|Toxicity|Patients who came off treatment due to toxicity.|Assessed up to 5 years|||participants|||Number
744998|NCT00511667|Secondary|Maximum Concentration (Cmax) of MK-0941 After Multiple Doses of MK-0941||Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day)|||nM||Standard Deviation|Mean
743575|NCT00486642|Secondary|Time to Disease Progression|Earliest date on which disease progression was determined by any of the methods listed: PSA progression, objective disease progression (Response Evaluation Criteria in Solid Tumors [RECIST] criteria) or cancer-related symptomatic progression.|Time from start of treatment to time criteria are met for disease progression or death from any cause, whichever came first, assessed up to 5 years|||months||95% Confidence Interval|Median
743576|NCT00486642|Secondary|Stable Disease Rate as Assessed by RECIST Criteria|RECIST Stable defined as - Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|Measured from the start of the treatment until the criteria for progression are met or death from any cause, whichever came first, assessed up to 5 years|5 evaluable patients in Arm A + 9 evaluable patients in Arm B||Participants|||Count of Participants
743577|NCT00486642|Secondary|Median Duration of PSA-Response|"Definition of PSA response: >= 50% fall (minimum 5 ng/ml) in PSA from baseline maintained for >4 weeks, and without other evidence of disease progression documented at time of confirmatory values.
PSA response duration will commence on the date of the first >=50% decline in PSA. The response duration ends when PSA progression criteria are met with the second increasing PSA value.
PSA progression in PSA responders: rise in PSA of 50% (minimum 5ng/ml) above nadir value and confirmed by a second increasing value at least 1 week later."|From time PSA response criteria are met until time PSA progression criteria are met or death from any cause, whichever came first, up to 5 years|1 patient in Arm A and 2 patients in Arm B had a PSA response.||months||Full Range|Median
743578|NCT00486642|Secondary|Progression-free Survival|"PFS is defined as the time from treatment initiation to disease progression or death from any cause, whichever came first.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions"|From time of treatment initiation to disease progression or death from any cause, whichever came first, assessed up to 5 years|||months||95% Confidence Interval|Median
743579|NCT00486642|Secondary|Objective Tumor Response Rate as Assessed by RECIST Criteria|RECIST PR defined as - At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|Time from start of treatment to time criteria are met for disease progression or death from any cause, whichever came first, assessed up to 5 years|5 evaluable patients in Arm A + 9 evaluable patients in Arm B||patient|||Number
743580|NCT00486642|Primary|PSA Response Rate|Prostate-specific antigen (PSA) response rate (defined as a confirmed > / = 50% decline (minimum 5ng/ml) in PSA from baseline maintained for >4 weeks, and without other evidence of disease progression documented at time of confirmatory values).|Up to 12 weeks|9 evaluable in Arm A + 12 evaluable in Arm B||Participants|||Count of Participants
743581|NCT00486720|Primary|Safety and Tolerability as Assessed by the Number of Participants With Adverse Events.||Every 21 days while on therapy and at 30 days after the last dose of study therapy|||Participants|||Number
743582|NCT00486720|Primary|Number of Responders and Number of Non-responders Defined by International Working Group Response Criteria|Number of responders is defined as the number of patients in the analysis population who have complete response (CR), partial response (PR), or hematologic improvement (HI) per International Working Group Response Criteria during the course of the study. Confirmation of CR or PR will require a second assessment performed 4 weeks or more after the initial assessment. Confirmation of HI will require a second assessment performed 8 weeks or more after the initial assessment. Number of non-responders is defined as the number of patients who did not achieve CR, PR or HI in the study.|2 Years|Full analysis set (FAS) population is the analysis population. This population consists of all randomized patients who have received at least one dose of study medication.||Participants|||Number
743583|NCT00486759|Secondary|Overall Response (OR) Assessed According to the Revised Response Criteria for Malignant Lymphoma|OR = a complete response (CR), an unconfirmed CR, or a partial response (PR). CR = Complete disappearance of disease and disease-related symptoms. All lymph nodes and nodal masses regressed on computed tomography (CT) to normal size (≤ 1.5 cm in their greatest transverse diameter for nodes > 1.5 cm prior to therapy and ≤ 1.0 cm in their short axis for nodes 1.1-1.5 cm in their long axis and > 1.0 cm in their short axis prior to therapy). Spleen and/or liver not palpable on physical examination, normal size by imaging, and disappearance of nodules related to lymphoma. If bone marrow was involved prior to therapy, infiltrate must have cleared on repeat biopsy. PR = ≥ 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses. No increase in the size of the other nodes, liver, or spleen. Splenic and hepatic nodules regressed by ≥ 50% in their SPD or, for single nodules, in the greatest transverse diameter. No new sites of disease.|At the end of treatment (Cycle 8, up to 12 months)|Intent-to-treat population: All randomized patients, regardless whether or not they had actually received the assigned treatments.||Percentage of patients|||Number
743584|NCT00486759|Secondary|Overall Survival|Overall survival was defined as the time from the date of randomization to the date of death due to any cause.|Baseline to end of the study (up to 4 years, 4 months)|Intent-to-treat population: All randomized patients, regardless whether or not they had actually received the assigned treatments.||Months||Inter-Quartile Range|Median
743585|NCT00486759|Primary|Progression-free Survival (PFS)|PFS was defined as the time from the date of randomization to the date of disease progression (PD)/relapse, as determined by the investigator, or death from any cause, whichever occurred earlier. A patient with PD/relapse must meet at least 1 of the following criteria: (1) Appearance of any new lesion > 1.0 cm in the short axis during or at the end of therapy. (2) ≥ 50 % increase from nadir in the sum of the products of diameters (SPD, maximum diameter of a tumor x largest diameter perpendicular to the maximum diameter) of any previously involved nodes, in a single involved node, or the size of other lesions (eg, splenic or hepatic nodules). To be considered progressive disease, a lymph node with a diameter of the short axis < 1.0 cm must increase by ≥ 50% to a size of 1.5 x 1.5 cm or > 1.5 cm in the long axis. (3) ≥ 50 % increase in the greatest diameter of any previously identified node > 1.0 cm in its short axis or in the SPD of more than 1 node.|Baseline to end of the study (up to 4 years, 4 months)|Intent-to-treat population: All randomized patients, regardless whether or not they had actually received the assigned treatments.||Months||Inter-Quartile Range|Median
744999|NCT00511667|Secondary|Area Under the Concentration-time Curve (AUC0-24) of MK-0941 After Multiple Doses of MK0941||Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day)|||nM-hr||Standard Deviation|Mean
743586|NCT00486811|Secondary|Patient Assessment of Constipation Symptoms (PAC-SYM) Over Time|"The Constipation Assessment (PAC-SYM) is a 12-item self-report questionnaire that assesses the severity of symptoms of constipation. Participants are asked How severe have each of these symptoms been in the last two weeks? e.g. Pain in your stomach. There are 3 subscales: 4 questions on Abdominal symptoms, 3 on rectal symptoms and 5 on stool symptoms. Responses are rated on a 5-point Likert scale ranging from 0 (absence of symptom) to 4 (very severe symptoms). If the changes in the overall or subscale scores are positive then there is a worsening in symptoms associated with constipation."|Change from Baseline to Week 12 of the Maintenance Period|Safety Set||Units on a scale||Standard Deviation|Mean
743587|NCT00486811|Secondary|Number of Participants Reporting a Category From the Quality of Sleep (Sleep Questionnaire)|"The Sleep Questionnaire addressed the following question: Please rate the overall quality of your sleep last night? The quality of sleep at baseline and prior to completion of treatment are reported. The participant can choose one of the following options: Excellent, good, fair and poor."|Week 12 of the maintenance period compared to baseline|Intention to treat (ITT). Last Observation Carried Forward (LOCF). The number of participants reporting the appropriate sleep quality category are shown.||participants|||Number
743588|NCT00486811|Secondary|Sleep Questionnaire: Number of Awakenings During Sleep|"The Sleep Questionnaire addressed the following question: How many times did you wake up during the night?. Sleep was assessed by the subject once a week during the entire double-blind treatment period. Reported are the baseline and end of maintenance period. Generally the less the number of awakenings the better the sleep."|Week 12 of the maintenance period compared with baseline|Intention to treat (ITT). Last Observation Carried Forward (LOCF). The number reflects the number of participants that had the specified awakenings.||participants|||Number
743589|NCT00486811|Secondary|Sleep Questionnaire: Amount of Time Slept in Hours|"The Sleep Questionnaire addressed the following question: How long did you sleep last night?. The mean change for the number of hours slept during the night before from baseline to 12 weeks was studied."|Baseline to Week 12 of the maintenance period|Intention to treat (ITT). Last Observation Carried Forward (LOCF)||hours||Standard Deviation|Mean
743590|NCT00486811|Secondary|Sleep Questionnaire: Change From Baseline in Sleep Latency Time in Hours to the Last Week of the Maintenance Period.|"The Sleep Questionnaire addressed the following question: How long after bedtime/lights out did you fall asleep last night(hours)?. The mean change from baseline to 12 weeks was studied. Decrease in time, measured in hours, indicates an improvement."|Week 12 of the maintenance period compared to baseline|Intention to treat (ITT). Last Observation Carried Forward (LOCF).||hours||Standard Deviation|Mean
743591|NCT00486811|Secondary|EuroQol-5 (EQ-5D) Health Status Index Outcome Over Time|"The participant scored the EuroQol-5. This is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating full health and 0 representing dead. The positive values indicate that during the study the health status improved."|Comparison of Baseline to Week 12 of the Maintenance Period|Intention to treat (ITT). Last Observation Carried Forward (LOCF).||Index value||Standard Error|Mean
743592|NCT00486811|Secondary|Change in the Health Survey Scores Form (SF-36)|The Scores Form 36 (SF-36) includes several brief board questions on 8 aspects, (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. A higher score indicates an improvement in health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state.|Change From Baseline to Week 12 of the Maintenance Period|The number indicate the available responses. For certain categories, e.g. Physical Functioning only 318 participants in the tapentadol treatment were analyzed and in the General Health analysis only 328 oxycodone- and 336 placebo-treated participants were available. Intention to treat (ITT). Last Observation Carried Forward (LOCF).||units on a scale||Standard Deviation|Least Squares Mean
743593|NCT00486811|Secondary|Time to Treatment Discontinuation Due to Lack of Efficacy|The median time to treatment discontinuation due to lack of efficacy from baseline to endpoint.|Baseline to week 12 of the maintenance period|Intention to treat (ITT) The results for median and interquartile ranges were not estimated as an insufficient number of participants discontinued due to lack of efficacy to estimate values.||days|||Number
743594|NCT00486811|Secondary|Change From Baseline in the Western Ontario McMaster Questionnaire (WOMAC) Global Score Assessing Pain, Disability and Joint Stiffness of the Knee Over the Last Week of the Maintenance Period at Week 12|Change from baseline to week 12 of Western Ontario McMaster Questionnaire (WOMAC) Global Score: WOMAC is measured with a Likert ordinal scale (the participant gives one of 5 possible answers) from 0 to 4. Higher scores indicate that a symptom is bothersome and physically disabling.|Change from baseline to week 12 of the maintenance period|Intention to treat (ITT). No imputation performed.||units on a scale||Standard Deviation|Mean
743595|NCT00486811|Secondary|Patient Global Impression of Change|In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant is requested to choose one of seven categories. Scores range from very much improved to very much worse.|Baseline; End of 12 week maintenance period|Intention to treat (ITT). Last observation carried forward (LOCF). Assessments obtained more than one day after end of treatment were not included in the analysis.||participants|||Number
743596|NCT00486811|Secondary|Change From Baseline of the Average Pain Intensity Based on an 11-point Numerical Rating Scale (NRS) Over the Last Week of the Maintenance Period at Week 12.|"The twice daily pain assessments were averaged. The participants were to indicate their pain on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. The lower the value the less pain intensity."|Change from Baseline to Week 12 of the Maintenance Period|Intention to treat (ITT). Last Observation Carried Forward (LOCF).||Units on a scale||Standard Deviation|Mean
743610|NCT00486863|Secondary|Number of Participants Whose Infant Was Born With Congenital Anomalies|The newborn was examined by the midwife at delivery and within 2-6 days of delivery to assess the presence of congenital anomalies and well-being. The newborn was also examined by study pediatrician at 28 days of life.|At delivery, within 2-6 days of delivery, and at 28 days|All newborns are included in the analysis.||participants|||Number
772983|NCT00734929|Secondary|Incidence of Nausea|operative procedure|Post operative procedure (OP) hours (0-2, 24, 48)|||participants|||Number
743597|NCT00486811|Primary|Change From Baseline of the Average Pain Intensity Overall in the 12-week Maintenance Period of the Daily Pain Intensity on an 11-point Numeric Rating Scale (NRS).|"For this twice daily pain assessment, the participants were required to indicate the level of pain experienced over the previous 12 hours on an 11-point Numeric Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. The lower the value the less pain in the treatment group. Negative values indicate a reduction in pain."|Change from baseline over the 12 week Maintenance Period|Intent-to-treat (ITT), Last Observation Carried Forward (LOCF)||Units on a scale||Standard Deviation|Mean
743598|NCT00486837|Secondary|Change in Neutrophil Number in Induced Sputum From Baseline at Week 4||Baseline vs Week 4|For Group 1, only 21 out of 28 subjects had applicable data to analyze. For Group 2, only 22 out of 28 subjects had applicable data to analyze.||percentage of change||Standard Deviation|Mean
743599|NCT00486837|Secondary|Change in Pseudomonas Load in Induced Sputum From Baseline at Week 4||Baseline vs Week 4|For Group 1, only 24 out of 28 subjects had applicable data to analyze. For Group 2, all 28 subjects had applicable data to analyze.||CFU/g||Standard Deviation|Mean
743600|NCT00486837|Secondary|Change in Total Bacterial Load in Induced Sputum From Baseline to Week 4||Week 4|For Group 1, only 24 out of 28 subjects had applicable data to analyze. For Group 2, all 28 subjects had applicable data to analyze.||CFU/g||Standard Deviation|Mean
743601|NCT00486837|Secondary|Change in Total Immunoglobulin G (IgG) Fragments in Induced Sputum From Baseline at Week 4||Baseline vs Week 4|For Group 1, only 24 out of 28 subjects had applicable data to analyze. For Group 2, only 26 out of 28 subjects had applicable data to analyze.||ug/mL||Standard Deviation|Mean
743602|NCT00486837|Secondary|Change in Alpha-1-anti-trypsin (A1AT) Activity in Induced Sputum From Baseline at Week 4||Baseline vs Week 4|For Group 1, only 24 out of 28 subjects had applicable data to analyze. For Group 2, only 27 out of 28 subjects had applicable data to analyze.||ug/mL||Standard Deviation|Mean
743603|NCT00486837|Primary|Change in Free Elastase in Induced Sputum From Baseline to Week 4||Baseline vs Week 4|Modified Intent-to-Treat Population (mITT) was all randomized subjects who received any amount of study medication and had at least one evaluation of the primary efficacy variable (free elastase in induced sputum) post baseline and at baseline (Visit 2).||ug/mL||Standard Deviation|Mean
743604|NCT00486863|Secondary|4-hydroxy Praziquantel Pharmacokinetic Concentrations|Since pregnancy is associated with increased cytochrome P450 activity and physiologic changes in the gastrointestinal tract that tend to reduce drug absorption, praziquantel pharmacokinetics may be affected by pregnancy. Thus, the metabolite-to-parent drug ratio may serve as a differential marker to help determine if variability in drug exposure following oral administration during pregnancy is due to altered metabolism or drug absorption. Samples that were collected from subjects who were randomized to receive praziquantel were analyzed for praziquantel and 4-hydroxy praziquantel concentrations. Assays were performed using high performance liquid chromatography–electrospray mass spectrometry in the University of California at San Diego Pediatric Clinical Pharmacology Laboratory. Descriptive statistics were obtained for concentrations at each of the four sparse sampling timepoints.|4.5 and 8 hours after the first praziquantel dose (subjects assigned to an even study number) or 6 and 10 hours after the first praziquantel dose (subjects assigned to an odd study number).|The analysis population for pharmacokinetics descriptive analyses was defined as all subjects who had plasma samples collected and who were randomized to receive PZQ (N=99; 50 subjects at 4.5 and 8 hr after first PZQ dose and 49 at 6 and 10 hr after first PZQ dose).||ng/ml||Inter-Quartile Range|Median
743605|NCT00486863|Secondary|Praziquantel Pharmacokinetic Concentrations|Two plasma samples were collected during the overnight hospitalization from approximately 200 subjects that remained at the time of study modification to incorporate PK studies. Subjects had samples collected based on one of two sample collection strategies: 4.5 and 8 hr after the first praziquantel dose or 6 and 10 hr after the first praziquantel dose. Subjects randomized to an even study number were assigned to the 4.5 and 8 hour schedule. Subjects randomized to an odd study number were assigned to the 6 and 10 hour schedule. Samples only from subjects randomized to receive praziquantel were analyzed for praziquantel. Samples drawn from subjects randomized to the control group were not analyzed. Praziquantel concentrations (ng/ml) were assayed using high performance liquid chromatography–electrospray mass spectrometry in the University of California at San Diego Pediatric Clinical Pharmacology Laboratory.|4.5 and 8 hours after the first praziquantel dose (subjects assigned to an even study number) or 6 and 10 hours after the first praziquantel dose (subjects assigned to an odd study number).|The analysis population for pharmacokinetics descriptive analyses was defined as all subjects who had plasma samples collected and who were randomized to receive PZQ (N=99; 50 subjects at 4.5 and 8 hr after first PZQ dose and 49 at 6 and 10 hr after first PZQ dose).||ng/mL||Inter-Quartile Range|Median
743606|NCT00486863|Secondary|Cytokeratin 18 Neo-epitope Staining as a Measure of Apoptosis|A study hypothesis was that peripheral serum obtained from S. japonicum infected, treated mothers would induce a lower level of apoptosis (programmed cell death) in cultured trophoblasts as measured by cytokeratin 18 neo-epitope staining compared to peripheral serum obtained from S. japonicum infected, PZQ untreated mothers. This assay was planned to be completed only if the primary objective was met; therefore, there will be no data for this outcome measure.|32 weeks gestation||||||
743607|NCT00486863|Secondary|Placental Blood Cytokine Levels|Cytokine assays were planned to be performed with culture supernatant harvested from placental explant cultures. The cytokines were to be measured with a multi-analyte analyzer. These assays were intended to be performed only if the primary objective of the study was met; therefore, there will be no results reported for this outcome measure.|At delivery||||||
743608|NCT00486863|Secondary|Maternal Serum Cytokine Levels of TNF-alpha, TNF-alpha Receptors I and II, IL-1, and IL-6|Extra-placental mechanisms mediating improved outcomes in the PZQ group were planned to be evaluated with maternal serum cytokine levels, particularly TNF-alpha, TNF-alpha receptors I and II, IL-1, and IL-6. These assays were intended to be performed only if the primary objective of the study was met; therefore, there will be no results reported for this outcome measure.|At 32 weeks gestation||||||
743609|NCT00486863|Secondary|Number of Participants With Pre-eclampsia|Participants were assessed for the presence of pre-eclampsia at both the 22 and 32 week visits. Pre-eclampsia was defined by the presence of proteinurea (2+ protein on urine dipstick) and a single diastolic blood pressure reading of 100 millimiters of mercury (mm Hg) or above OR more than one reading, four hours apart, of 90 mm Hg or above.|22 weeks and 32 weeks|All participants seen at both timepoints are included.||participants|||Number
743611|NCT00486863|Secondary|Number of Participants Reporting Abnormalities in Clinical Chemistry Assessments Within 24 Hours of Dosing|Toxicity to maternal kidney and liver was assessed by laboratory parameters collected just before and 24 hours after dosing. Specifically, blood was drawn just before the dose at 12-16 weeks gestation to determine baseline blood urea nitrogen (BUN), creatinine, aspartate aminotransferase (AST), alanine aminotransferase (ALT), and bilirubin. Blood was then drawn 24 hours after the second part of the split dose and before discharge from the hospital to assess any changes in these parameters. Any values that were 1.1 times the upper limit of normal or greater for the parameter were considered abnormal.|Just before and 24 hours after dosing|All participants were included in this analysis.||participants|||Number
743612|NCT00486863|Secondary|Number of Participants Reporting Abnormalities in Hematology Assessments Within 24 Hours of Dosing|Toxicity to maternal bone marrow, kidney, and liver was assessed by laboratory parameters collected just before and 24 hours after dosing. Specifically, blood was drawn just before the dose at 12-16 weeks gestation to determine baseline complete blood count, including white blood count (WBC), platelets, and hemoglobin. Blood was then drawn 24 hours after the second part of the split dose and before discharge from the hospital to assess any changes in these parameters. White blood count was abnormal at or above 10,800 or at or below 3500 cells/square millimeter (sq mm), platelets were abnormal at or below 140,000 cells/sq mm, and hemoglobin was abnormal at or below 10.9 grams/deciliter (g/dL).|Just before and 24 hours after dosing|All participants were included in this analysis.||participants|||Number
743613|NCT00486863|Secondary|Number of Participants Experiencing Fetal Loss by Abortion|Abortion was defined by the protocol as bleeding followed by fetal loss as supported by ultrasound before 20 weeks gestation. Abortion was an important safety outcome measure due to the fact that abortion would occur closer to the time of dosing than miscarriage or stillbirth. Participants were observed in hospital for 24 hours after dosing and asked to return for any bleeding at any time.|After dosing and before 20 weeks gestation|All participants were included in this analysis.||participants|||Number
743614|NCT00486863|Secondary|Number of Participants Reporting Serious Adverse Events Within 24 Hours of Dosing|Participants were observed in hospital for 24 hours after dosing for serious adverse events. Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof (for reasons other than the 24-hour observation period); resulted in a congenital anomaly/birth defect; or may have jeopardized the participant, or required intervention to prevent one of these outcomes.|Within 24 hours of dosing|All participants were included in this analysis.||participants|||Number
743615|NCT00486863|Secondary|Number of Subjects With Reduction in S. Japonicum Egg Counts From Screening to 22 Weeks Gestation of Greater Than 90 Percent|Parasitologic response to treatment was evaluated by counting S. japonicum eggs per gram of stool at screening and again at 22 weeks gestation. Success of treatment was pre-specified as greater than 90 percent reduction in egg count from screening to 22 weeks gestation.|Screening and 22 weeks gestation|All participants for whom egg counts were reported are included in the analysis.||participants|||Number
743616|NCT00486863|Secondary|Newborn Median Serum Transferrin Receptor:Ferritin Ratio|To assess total body iron, the serum transferrin receptor:ferritin ratio was assessed in the infant. At delivery, a heel stick blood sample and a cord blood sample were collected for assessment of total body iron by determination of the transferrin receptor:ferritin ratio.|0-6 days after delivery.|All infants for whom transferrin receptor and ferritin were reported are included in the analysis.||ratio||Inter-Quartile Range|Median
743617|NCT00486863|Secondary|Mean Change in Maternal Thigh Skinfold Thickness From 14 to 32 Weeks Gestation|Maternal fat stores were measured by thigh skinfold thickness obtained using a Holtain skinfold caliper. The thickness increase from 14 to 32 weeks was determined for each participant, and the mean and standard deviation calculated.|14 and 32 weeks gestation|All participants for whom thigh skinfold thickness was reported at both timepoints were included in this analysis.||millimeters||Standard Deviation|Mean
743618|NCT00486863|Secondary|Mean Change in Maternal Weight From 14 to 32 Weeks Gestation|Maternal weight gain was assessed by measuring participants' weight in kilograms. The weight increase from 14 to 32 weeks was determined for each participant, and the mean and standard deviation calculated.|14 and 32 weeks gestation|All participants for whom weight was reported at both timepoints were included in this analysis.||kilograms||Standard Deviation|Mean
743619|NCT00486863|Secondary|Median Maternal Hepcidin at 32 Weeks Gestation|Anemia of inflammation was assessed via maternal urine hepcidin levels. In response to inflammation, elevated serum levels of hepcidin is synthesized. Hepcidin causes sequestration of iron from bio-available forms to storage forms such as ferritin and decreases intestinal absorption of iron. Hepcidin was measured in participants' urine at 32 weeks gestation.|32 weeks gestation|All participants for whom hepcidin levels were reported are included in the analysis.||nanograms/milliliter||Inter-Quartile Range|Median
743620|NCT00486863|Secondary|Median Change in Maternal Transferrin Receptor:Ferritin Ratio From 14 to 32 Weeks Gestation|To assess total body iron, one needs to assess the storage compartment, which will contain sequestered iron, and the functional compartment, which represents bioavailable iron. Body iron status is defined by the two laboratory measurements that reflect these compartments, ferritin and serum transferrin receptor. The serum transferrin receptor:ferritin ratio has been shown in quantitative phlebotomy studies to provide an accurate assessment of total body iron over the entire range of status. At 14 and 32 weeks gestation, a blood sample was collected for assessment of total body iron by determination of the transferrin receptor:ferritin ratio. Each participant's change in ratio was calculated, and the median and interquartile range were determined for each group.|14 weeks and 32 weeks gestation|All participants for whom transferrin receptor:ferritin ratio was reported at both timepoints are included in the analysis.||ratio||Inter-Quartile Range|Median
743621|NCT00486863|Secondary|Mean Change in Maternal Hemoglobin From 14 to 32 Weeks Gestation|Hemoglobin concentration in a venous blood sample collected at 14 and 32 weeks gestation was measured using a multi-analyte analyzer. Each participant's change in hemoglobin concentration between the two timepoints was determined, and the mean and standard deviation for each group calculated.|14 weeks and 32 weeks gestation|All participants for whom hemoglobin concentrations were reported are included in the analysis.||grams/deciliter||Standard Deviation|Mean
743622|NCT00486863|Secondary|Number of Participants Whose Pregnancy Resulted in a Live Birth|Each participant was followed until delivery to record if the outcome of the pregnancy was a live birth. Live births were defined as the complete expulsion or extraction from its mother of a product of conception, irrespective of the duration of the pregnancy, which, after such separation, breathes or shows any other evidence of life such as heartbeat, umbilical cord pulsation, or definite movement of voluntary muscles, whether the umbilical cord had been cut or the placenta was attached.|At delivery|All participants for whom the status of the infant at delivery was reported are included in the analysis.||participants|||Number
743623|NCT00486863|Primary|Mean Newborn Birth Weight|Birth weight was collected for live infants at the time of delivery by a trained midwife, or within 24 hours of delivery for participants who chose to deliver at home with a helot, a birth attendant without formal training.|Within 24 hours of delivery.|All newborns for whom birth weights were reported were included in the analysis.||kilograms||Standard Deviation|Mean
743624|NCT00486902|Post-Hoc|Pain Score (0-10) at 2 Weeks Following Cesarean Delivery|Numeric rating for pain score (0 to 10) reported at 2 weeks following cesarean delivery. Zero is no pain and 10 is worst pain imaginable.|2 weeks|||Scores on a scale||Inter-Quartile Range|Median
743625|NCT00486902|Secondary|Disturbing Dreams|Number of subject reporting disturbing dreams at 72 hours post cesarean delivery|72 hours|||participants|||Number
743626|NCT00486902|Secondary|Postperative Pruritus|Number of subjects with pruritus in the first 24 hours following cesarean delivery|24 hours|||participants|||Number
743627|NCT00486902|Secondary|Postoperative Vomiting|Number of subjects that vomited in the first 24 hours following cesarean delivery|24 hours|||participants|||Number
743628|NCT00486902|Secondary|Postoperative Nausea|Number of subjects reporting nausea in first 24 hours following cesarean delivery|24 hours|||participants|||Number
743629|NCT00486902|Secondary|Cumulative Hydrocodone/Acetaminophen for Supplemental Analgesia to Treat Breakthrough Pain|Cumulative hydrocodone/acetaminophen for supplemental analgesia to treat breakthrough pain for 72 hours following cesarean delivery|72 hours|Analysis was per protocol||tablets||Inter-Quartile Range|Median
743630|NCT00486902|Secondary|Verbal Pain Scores (0 to 10) at First Analgesia Request|Numeric rating of pain scores (NRS) scale (0 to 10) at time of supplemental analgesia request. Zero is no pain and 10 is worst pain imaginable.|24 hours|||Scores on a scale||Inter-Quartile Range|Median
743631|NCT00486902|Primary|Number of Subjects Requiring Supplemental Analgesia in the First 24 Hours Following Cesarean Delivery|Request for oral hydrocodone/acetaminophen for pain not controlled by around the clock non-steroidal antiflammatory drugs in the first 24 hours following cesarean delivery.|24 hours|Analysis was performed per protocol||participants|||Number
743632|NCT00492284|Secondary|Mean Change From Baseline in Lesion Size|Mean change from baseline in lesion size measured as greatest linear dimension (GLD) of the lesion|Baseline to Month 12, Baseline to Month 24|Intent-to-treat and last observation carried forward||micron||Standard Deviation|Mean
743633|NCT00492284|Secondary|Mean Change From Baseline in Central Retinal Thickness||Baseline to Month 12, Baseline to Month 24|Intent-to-treat and last observation carried forward||micron||Standard Deviation|Mean
743634|NCT00492284|Secondary|Percentage of Subjects With >=15 Letters of Visual Acuity Lost From Baseline||Baseline to Month 12, Baseline to Month 24|Intent-to-treat and last observation carried forward||Percentage of participants||95% Confidence Interval|Mean
743635|NCT00492284|Secondary|Percentage of Subjects With >=0 Letter Gain of Visual Acuity From Baseline||Baseline to Month 12, Baseline to Month 24|Intent-to-treat and last observation carried forward||Percentage of participants||95% Confidence Interval|Mean
743636|NCT00492284|Secondary|Percentage of Subjects With >=15 Letters of Visual Acuity Gained From Baseline||Baseline to Month 12, Baseline to Month 24|Intent-to-treat and last observation carried forward||Percentage of participants||95% Confidence Interval|Mean
743637|NCT00492284|Secondary|Mean Change From Baseline in Study Eye Best-Corrected VA Score|Early Treatment Diabetic Retinopathy Study (ETDRS) method at 4 meters. Worst = 0; best = 100|Baseline to Month 24|||Letters read on ETDRS chart||95% Confidence Interval|Mean
743638|NCT00492284|Secondary|Mean Number of Retreatments (Day 0 Excluded)|Retreatment was defined in the protocol as study treatment administered after Day 0. For the analyses of retreatment, any study treatment that was administered was considered to be a retreatment, and combination therapy was considered to be one retreatment, even though two or three treatment procedures were done. In the combination therapy groups, if a ranibizumab injection was given because retreatment was indicated and the previous combination treatment was less than 2 months before, the ranibizumab injection was counted as a retreatment.|Month 1 to Month 24|Intent-to-treat||number of retreatments||95% Confidence Interval|Mean
743639|NCT00492284|Primary|Mean Change From Baseline in Study Eye Best-corrected VA Score (ETDRS Chart)|Early Treatment Diabetic Retinopathy Study (ETDRS) method at 4 meters. Worst = 0; best = 100|Baseline to Month 12|Intent-to-treat and last observation carried forward||Letters read on ETDRS chart||95% Confidence Interval|Mean
743640|NCT00492284|Primary|Mean Number of Retreatments (Day 0 Excluded)|Retreatment was defined in the protocol as study treatment administered after Day 0. For the analyses of retreatment, any study treatment that was administered was considered to be a retreatment, and combination therapy was considered to be one retreatment, even though two or three treatment procedures were done. In the combination therapy groups, if a ranibizumab injection was given because retreatment was indicated and the previous combination treatment was less than 2 months before, the ranibizumab injection was counted as a retreatment.|Month 1 to Month 12|Intent-to-treat||number of retreatments||95% Confidence Interval|Mean
743641|NCT00492297|Secondary|Time to Progression|Time to Progression was the number of days from the start of therapy to progression (if patient progressed then censored=no) or to the last observation at which the patient was known to have not progressed, that is, the last observation with a best response of CR, PR, or SD.|From start of treatment until progression (median 259 days)|There were 83 subjects in the intent-to-treat (ITT) population. Of these 83, 78 were included in this analysis.||days||95% Confidence Interval|Median
743642|NCT00492297|Secondary|Time to Response|Time to Response in subjects who achieved an objective response (PR or CR with confirmation) was measured from the date of starting study combination treatment until the earliest date that the response was first documented.|start of therapy to confirmed CR or PR (median 259 days)|There were 83 subjects in the intent-to-treat (ITT) population. Only the 10 subjects who had a PR or CR were included in this analysis.||days||95% Confidence Interval|Median
743643|NCT00492297|Secondary|Duration of Stable Disease|Duration of Stable Disease (DSD), defined as the time from the first documented objective evidence of Stable Disease (SD) to disease progression (DP) or death if death occurred before DP, was assessed in subjects who showed SD as best response. DSD for subjects who had not progressed or died was censored at the date of last tumor assessment.|from start of therapy to PD, only in non-responders (median 259 days)|There were 83 subjects in the intent-to-treat (ITT) population. Only the 70 subjects who had a Best Response of Stable Disease, ie, those who failed to achieve a Best Response of CR or PR, were included in this analysis.||days||95% Confidence Interval|Median
743644|NCT00492297|Secondary|Disease Control (DC)|DC was defined as the total number of subjects whose best response was not progressive disease (PD) (total number of CRs + total number of PRs + total number of Stable Diseases (SD)). The DC at specific time points could also be calculated as the total number of subjects whose response was not PD at that time point.|after start of treatment, at 6 months and 12 months|There were 83 subjects in the intent-to-treat (ITT) population. All 83 were included in this analysis.||participants|||Number
743645|NCT00492297|Secondary|Duration of Partial Response|Duration of partial response was the number of days from the date that a partial response was first documented to the date that recurrent or progressive disease was first objectively documented (if patient progressed then censored=no) or to last observation (if patient did not progress then censored=yes).|from confirmed PR until PD (median 259 days)|There were 83 subjects in the intent-to-treat (ITT) population. Only the 9 subjects who had a PR were included in this analysis.||days||95% Confidence Interval|Median
743646|NCT00492297|Secondary|Duration of Complete Response|Duration of complete response was the number of days from the date that a complete response was first documented to the date that recurrent or progressive disease was first objectively documented (if patient progressed then censored=no) or to last observation (if patient did not progress then censored=yes).|from confirmed CR until PD (median 259 days)|There were 83 subjects in the intent-to-treat (ITT) population. Only the 1 subject who had a CR was included in this analysis (duration 420 days, censored).||days|||Number
743647|NCT00492297|Secondary|Duration of Response|Duration of Response was assessed in subjects who showed a Partial Response (PR) or Complete Response (CR). It was defined as the time from the first documented objective response to Progressive Disease (PD), or death if before documented progression. Duration of response for subjects who have not progressed or died at the time of analysis was censored at the date of last tumor assessment.|from confirmed Complete Response (CR) or Partial Response (PR) until Progressive Disease (PD) (median 259 days)|There were 83 subjects in the intent-to-treat (ITT) population. Only the 10 subjects who had a PR or CR were included in this analysis.||days||Full Range|Median
743648|NCT00492297|Secondary|Overall Survival|Overall Survival was the number of days from the date that combination treatment started until the date of death.|from start of treatment until death (median 259 days)|There were 83 subjects in the intent-to-treat (ITT) population. All 83 were included in this analysis.||days||95% Confidence Interval|Median
743649|NCT00492297|Secondary|Percentage of Subjects With Progression-free Survival at Specific Time-points|Progression-free Survival (PFS) was the time from the first dose of combination therapy to disease progression (radiological or clinical, whichever is earlier) or death (if death occurs before progression is documented). PFS for subjects without tumor progression or death at the time of analysis were censored at the date of last tumor evaluation.|from start of treatment until progression or death before progression after 3, 6 and 12 months|There were 83 subjects in the intent-to-treat (ITT) population. All 83 were included in this analysis.||percentage of participants|||Number
743650|NCT00492297|Secondary|Progression-free Survival|Progression-free Survival (PFS) was the time from the first dose of combination therapy to disease progression (radiological or clinical, whichever is earlier) or death (if death occurs before progression is documented). PFS for subjects without tumor progression or death at the time of analysis were censored at the date of last tumor evaluation.|from start of treatment until progression or death before progression (median 259 days)|There were 83 subjects in the intent-to-treat (ITT) population. All 83 were included in this analysis.||days||95% Confidence Interval|Median
743651|NCT00492297|Primary|Overall Best Response|Best Overall Response (BOR): Best tumor response achieved during or within 30 days after active therapy confirmed according to the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR): The disappearance of all target and non-target lesions. Partial response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. SD was defined as steady state of disease, PD was defined as an increase of at least 20% increase in the sum of the LD of target lesions or appearance of new lesions.|during or within 30 days after active therapy|There were 83 subjects in the intent-to-treat (ITT) population. Of these, 75 were evaluable for Best Response; 8 were not evaluable.||participants|||Number
743652|NCT00492336|Secondary|Side Effect Checklist and Vital Signs||Weekly||||||
743653|NCT00492336|Secondary|Simpson Angus Scale||Every 4 weeks||||||
743654|NCT00492336|Secondary|Neuropsychological Tests, Including RBANS, Probabilistic Learning Task, and N-Back Task||Beginning of treatment phase (week 0) and end of treatment phase (week 12)||||||
743655|NCT00492336|Primary|Scale for the Assessment of Negative Symptoms (SANS)|"Scores on the subscales are combined (summed) to compute a total score. There are a total of 17 subscales. Each subscale ranges from 0=Not at all to 5=Severe. Every 4 weeks the summed subscale scores provide a total score for that week (0-85). These total scores from each week are then combined (summed) for an overall score and then averaged for the two groups after the 12 week period."|Every 4 weeks over a 12 week period|||units on a scale||Standard Deviation|Mean
743656|NCT00492401|Secondary|Measurement of Gene Expression in Peripheral Blood or Bone Marrow|Standard paired statistical tests, parametric and nonparametric, will be used to baseline with treatment values. With data collected serially over time, repeated measures analysis of variance will be used to analyze data.|From baseline to up to day 28 of course 1|Data was not collected and analyzed for this trial|||||
743657|NCT00492401|Secondary|Measurement of HbF in Peripheral Blood or Marrow Cells|Standard paired statistical tests, parametric and nonparametric, will be used to baseline with treatment values. With data collected serially over time, repeated measures analysis of variance will be used to analyze data.|From baseline to up to days 28 of course 2|Data was not collected and analyzed for this trial|||||
745000|NCT00511667|Primary|Participants With Any Clinical Adverse Experience||Approximately 30 days after last dose of study drug (14 days for participants receiving MK0941 40 mg before each meal)|||percentage of of participants|||Number
743658|NCT00492401|Secondary|Measurement of DNMT Protein in Peripheral Blood or Bone Marrow Cells|Expression studies were conducted using quantitative RT PCR. Expression of DNMT were normalized to the internal control to the ABL and levels of miR-29 to RNA U44.|Pre treatment|Only pre treatment samples available for testing for 23 patients||delta delta CT values||Inter-Quartile Range|Median
743659|NCT00492401|Secondary|Measurement of DNA Methylation in Peripheral Blood or Bone Marrow Cells|Standard paired statistical tests, parametric and nonparametric, will be used to baseline with treatment values. With data collected serially over time, repeated measures analysis of variance will be used to analyze data.|From baseline to up to day 28 of course 1|Data was not collected and analyzed|||||
743660|NCT00492401|Primary|Rate of Complete Remission|Per International Working Group criteria: Morphologic complete remission (CRm): Defined as morphologic leukemia-free state, including <5% blasts in BM aspirate with marrow spicules and a count of > 200 nucleated cells and no blasts with Auer rods, no persistent extramedullary disease, ANC > 1000/uL, platelet count > 100,000/uL. Patient must be independent of transfusions for a minimum of 1 week before each marrow assessment. Morphologic complete remission with incomplete blood count recovery (CRi): Defined as CR with the exception of neutropenia <1000/uL or thrombocytopenia <100,000/ul. Complete Remission Rate (CRm + CRi)|Up to 24 weeks|||patients|||Number
743661|NCT00492531|Primary|Change in Exercise Capacity as Assessed by 6 Minute Walk.|The primary outcome measure was change in exercise capacity assessed by 6 minute walk distance in meters from baseline to 16 weeks. Subjects without a week 16 assessment had their last observation carried forward.|Baseline to week 16/Imputed last visit.|All efficacy and safety analyses were conducted on the intent-to-treat (ITT) population, defined as all randomized subjects, regardless of therapy received. Pre-defined imputation rules:A value of 0 meters was imputed for subjects who died during the MIT.Subjects without a week 16 assessment had their last observation carried forward (LOCF).||meters||Standard Deviation|Mean
743662|NCT00492531|Secondary|Brain Natriuretic Peptide(BNP)Levels.||16 weeks|||pg/dl||Standard Deviation|Mean
743663|NCT00492531|Secondary|Borg Dyspnea Score|Borg dyspnea score was used to measure the level of severity of breathlessness perceived by the patient before and after 6 minute walk. The severity is measured on a 10 point scale with 0= nothing at all and 10=maximum severity of breathlessness.|baseline to 16 weeks|||Score on a scale||Standard Deviation|Mean
743664|NCT00492531|Secondary|Change From Baseline in Pulmonary Hypertension at Week 16 as Assessed by Tricuspid Regurgitant Jet Velocity|Secondary outcome measure was change from baseline in Pulmonary hypertension at week 16 as assessed by Tricuspid regurgitant jet velocity(TRV). Tricuspid regurgitant jet velocity was measured by transthoracic Doppler Echocardiography.|16 weeks|||meters/second||Standard Deviation|Mean
743665|NCT00492544|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters|"Abnormalities include values outside (above or below) the normal ranges.
Normal ranges:
alanine aminotransferase (ALT): 5-35 U/L aspartate aminotransferase (AST): 5-50 U/L basophils: 0-2 % bilirubin total: 0.1-1.1 mg/dL blood urea nitrogen: 0-20 mg/dL creatinine: 0.2-1.2 mg/dL eosinophils: 0-7 % hematocrit: 30-45 % hemoglobin: 10-15 g/dL lymphocytes: 18-50 % monocytes: 1-8 % neutrophils: 42-74 % platelets: 10-60 10E4/microL red blood cells: 350-550 10E4/microL total protein: 6.5-8.6 g/dL white blood cells: 4000-15000 /microL"|At Day 0 and Month 7|||subjects|||Number
743666|NCT00492544|Primary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed include arthralgia, fatigue, fever, gastrointestinal symptoms, headache, myalgia, rash, and urticaria.|During the 7-day (Days 0-6) period following each vaccination|||subjects|||Number
743667|NCT00492544|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|Serious adverse events assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Day 0 up to Month 7|||subjects|||Number
743668|NCT00492544|Secondary|Outcome of All Pregnancies|According to the study protocol, the outcome of all pregnancies reported during the entire study period was to be reported, even if delivery occurs after the end of the study.|Up to Month 7|There were no pregnancies reported between Day 0 and Month 7 in the Total Vaccinated Cohort.|||||
743669|NCT00492544|Secondary|Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Other Medically Significant Conditions|NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes. Medically significant conditions assessed include adverse events prompting emergency room visits and physician office visits not related to common illnesses or Serious Adverse Events that are not related to common illnesses.|From Day 0 up to Month 7|||subjects|||Number
743670|NCT00492544|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|"Unsolicited adverse event= Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event."|During the 30-day (Days 0-29) period following each vaccination|||subjects|||Number
743671|NCT00492544|Primary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling.|During the 7-day (Days 0-6) period following each vaccination|||subjects|||Number
743672|NCT00492544|Primary|Anti-HPV-16 and Anti-HPV-18 Antibody Titers|Titers are given as geometric mean titers (GMTs) calculated on all subjects.|Before vaccination (PRE) and one month post Dose 3 (Month 7)|Analysis was performed on the ATP cohort for immunogenicity.||titer||95% Confidence Interval|Geometric Mean
743673|NCT00492544|Primary|Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies|"Seroconversion is defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination.
Cut-off values were 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies."|One month post Dose 3 (Month 7)|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity.||subjects|||Number
743731|NCT00498706|Primary|Depression, as Assessed by Hamilton Depression Rating Scale(Ham-D)|Ham-D indicates Hamilton Depression Rating Scale,range is 0 to 52. A score of 0 means the best outcome with no depression symptoms reported, and a score of 52 is the worse outcome with highest level of depression reported. A difference of 3 points on the Hamilton scale has been identified as clinically significant.|Measured at baseline; Weeks 4, 9, 14, and 18; and Months 3, 6, 9, and 12 of follow-up|||units on a scale||Full Range|Mean
743674|NCT00492557|Post-Hoc|13vPnC Comparisons: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)|Pneumococcal OPA GMTs for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of a subset of participants using a microcolony OPA (mcOPA) assay.|1 month after 13vPnC vaccination|Evaluable immunogenicity population: had participants who adhered to protocol requirements, had valid and determinate assay results, and had no major protocol violations. n= number of participants with a determinate OPA antibody titer to the given serotype.||Geometric mean titers||95% Confidence Interval|Geometric Mean
743675|NCT00492557|Other Pre-specified|Percentage of Participants With Pre-specified Systemic Events|Systemic events (Any fever >= 38 degrees Celsius [C]), fatigue, headache, chills, rash, vomiting, decreased appetite, new muscle pain, any aggravated muscle pain, new joint pain or any aggravated joint pain. Participants may be presented in more than one category.|Days 1 through 14 after 13vPnC vaccination|Safety population: included all participants who received at least 1 dose of study vaccine. n=number of participants at each timepoint, in each group respectively.||Percentage of participants|||Number
743676|NCT00492557|Other Pre-specified|Percentage of Participants With Pre-specified Local Reactions|Local reactions were reported using an electronic diary. Pain was scaled as Any; Mild (awareness but easily tolerated); Moderate (discomfort enough to interfere with usual activity) and Severe (incapacitating the usual activity). Redness and swelling were scaled as Any; Mild (2.5 cm to 5.0 cm); Moderate (5.1 to 10.0 cm)and Severe (> 10.0 cm). Limitation in arm movement were scaled as Any; Mild (some limitation); Moderate (unable to move above head but able to move above shoulder) and Severe (unable to move above shoulder).|Days 1 through 14 after 13vPnC vaccination|Safety population: included all participants who received at least 1 dose of study vaccine. n=number of participants at each timepoint, in each group respectively.||percentage of participants|||Number
743677|NCT00492557|Primary|13vPnC Comparisons: Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC)|IgG GMC as measured by enzyme-linked immunosorbent assay (ELISA) and expressed in micrograms per mL (mcg/mL) for serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.|1 month after 13vPnC vaccination|Evaluable immunogenicity population: had participants who adhered to protocol requirements, had valid and determinate assay results, and had no major protocol violations.||mcg/mL||95% Confidence Interval|Geometric Mean
743678|NCT00492557|Primary|TIV Comparisons: Percentage of Participants Achieving at Least a 4-fold Increase in the Titer of the Standard Hemagglutination Inhibition Assay (HAI)|Percentage of participants achieving at least a 4-fold increase in the titer of the standard HAI for each influenza virus subtype (A/H1N1, A/H3N2, and B) were compared.|Baseline and 1 month after TIV vaccination|Evaluable immunogenicity population: had participants who adhered to protocol requirements, had valid and determinate assay results, and had no major protocol violations.||Percentage of participants||95% Confidence Interval|Number
743679|NCT00492583|Primary|Number of Days Children Are Out of School Sick|"Outcome measure, number of days children are out of school sick was measured for the entire population"|90 days|||days per 100 person days|||Number
743680|NCT00492622|Primary|Area Under the Curve for Omeprazole Plasma Concentration|The area under the curve for omeprazole concentration-time curve for immediate release and delayed release omeprazole.|0 to 5 hrs after the study drug was ingested on treatment day 7|the AUC for each formulation were combined regardless of order given||mg*h/mL||Standard Deviation|Mean
743681|NCT00492622|Primary|Maximal Concentration of Omerazole|Maximal concentration of immediate-release vs. delayed-release omeprazole|10, 20, 30, 45, 60, 90, 120, 150, 180, 210, 240 and 300 min after the study drug was ingested on day 7 of treatment|All subjects were included, regardless of which formulation they received first.||ng/mL plasma||Standard Deviation|Mean
743682|NCT00492622|Primary|Time to Maximal Omeprazole Concentration (Tmax)|Time to max concentration for Immediate release vs. Delayed release omeprazole|10, 20, 30, 45, 60, 90, 120, 150, 180, 210, 240 and 300 min after the study drug was ingested on day 7 of treatment|All subjects were included regardless of which formulation they received first.||minutes||Standard Deviation|Mean
743683|NCT00492726|Secondary|Duration of Hospitalization Postoperatively|Duration of hospitalization after the first surgery until discharge in the per protocol population.|Duration of hospitalization after the first surgery until discharge date (from 4 to 71 days after start of study medication)|Numbers refer to patients in the per protocol population with known end of hospitalization date.||days||Standard Deviation|Mean
743684|NCT00492726|Secondary|Duration of Hospitalization|Duration of hospitalization in the per protocol population.|From the first admission date to the discharge date (from 4 to 71 days after start of study medication)|Numbers refer to patients in the per protocol population with known end of hospitalization date.||days||Standard Deviation|Mean
743685|NCT00492726|Secondary|Number of Subjects Who Died Due to Intra-abdominal Infections|Number of subjects who had died due to intra abdominal infections by the time of TOC visit.|21 - 28 days after end of treatment at TOC Visit|Per protocol population comprising subjects with no major protocol deviations that would have influenced the primary outcome.||participants|||Number
743686|NCT00492726|Secondary|Number of Subjects Achieving Clinical Cure at TOC Visit in the Per Protocol Population With Causative Organism(s)|Clinical cure at TOC = resolution or improvement of clinical signs and symptoms related to the infection without the occurrence of a wound infection requiring a systemic antibiotic treatment. Clinical failure at TOC = either failure to respond or insufficient lessening of the signs and symptoms of infection at end of treatment (EOT) or reappearance of the signs and symptoms of the original infection from EOT up to TOC or wound infection requiring additional systemic antimicrobial therapy at any time up to TOC.|21 - 28 days after end of therapy|Per protocol population (subjects with no major protocol deviations that would have influenced the primary outcome) with causative organism(s).||participants|||Number
743687|NCT00492726|Secondary|Number of Subjects Achieving Bacteriological Success at TOC Visit in the Per Protocol Population With Causative Organism(s)|Bacteriological success = response classified as ‘eradication’ or ‘presumed eradication’ without occurrence of a superinfection. Bacteriological failure = response classified as ‘persistence’, ‘presumed persistence’, or ‘superinfection’ – additionally, any recurrence or reinfection was treated as bacteriological failure at TOC.|21 - 28 days after end of therapy|Per protocol population (subjects with no major protocol deviations that would have influenced the primary outcome) with causative organism(s).||participants|||Number
747604|NCT00530842|Secondary|Static Lung Volumes|Post-dose RV (Residual Volume) after 4 weeks (measured by bodyphlethysmography)|4 weeks|FAS using imputed values||Litres||Standard Error|Mean
743688|NCT00492726|Secondary|Number of Subjects Achieving Bacteriological Success at EOT Visit in the Per Protocol Population With Causative Organism(s)|Bacteriological success = response classified as ‘eradication’ or ‘presumed eradication’ without occurrence of a superinfection. Bacteriological failure = response classified as ‘persistence’, ‘presumed persistence’, or ‘superinfection’.|After 5 - 14 days of therapy|Per protocol population (subjects with no major protocol deviations that would have influenced the primary outcome) with causative organism(s). For one patient in the Moxifloxacin group, the data is missing due to missing EOT visit (not displayed in the table below).||participants|||Number
743689|NCT00492726|Secondary|Number of Subjects Achieving Clinical Cure at End of Therapy (EOT) Visit in the Per Protocol Population|Clinical cure = resolution/improvement of clinical signs and symptoms related to the infection without wound infection requiring systemic antibiotic treatment. Clinical failure = Failure to respond/insufficient lessening of signs and symptoms of infection requiring a modification/addition of antibacterial therapy, or a second surgical intervention (unless the original surgery was deemed inadequate). Development of a wound infection requiring alternative/additional antibiotic therapy was considered a failure. Failed subjects must have had 3 full days of therapy administered.|after 5 - 14 days of therapy|Per protocol population comprising subjects with no major protocol deviations that would have influenced the primary outcome.||participants|||Number
743690|NCT00492726|Secondary|Number of Subjects Achieving Bacteriological Success During Treatment in the Per Protocol Population With Causative Organism(s)|Bacteriological success = response classified as ‘eradication’ or ‘presumed eradication’ without occurrence of a superinfection. Bacteriological failure = response classified as ‘persistence’, ‘presumed persistence’, or ‘superinfection’.|During treatment at day 5 +/- 1 day|Per protocol population (subjects with no major protocol deviations that would have influenced the primary outcome) with causative organism(s).||participants|||Number
743691|NCT00492726|Secondary|Number of Subjects Achieving Clinical Improvement During Treatment in the Per Protocol Population|Clinical improvement = Reduction in the severity and/or number of signs and symptoms of infection.Clinical failure = Failure to respond/insufficient lessening of signs and symptoms of infection requiring a modification/addition of antibacterial therapy, or a second surgical intervention (unless the original surgery was deemed inadequate). Development of a wound infection requiring alternative/additional antibiotic therapy was considered a failure. Failed subjects must have had 3 full days of therapy administered.|During treatment at day 5 +/- 1 day|Per protocol population comprising subjects with no major protocol deviations that would have influenced the primary outcome.||participants|||Number
743692|NCT00492726|Primary|Number of Subjects Achieving Clinical Cure at Test of Cure (TOC) Visit in the Per Protocol Population|Clinical cure at TOC = resolution or improvement of clinical signs and symptoms related to the infection without the occurrence of a wound infection requiring a systemic antibiotic treatment. Clinical failure at TOC = either failure to respond or insufficient lessening of the signs and symptoms of infection at end of treatment (EOT) or reappearance of the signs and symptoms of the original infection from EOT up to TOC or wound infection requiring additional systemic antimicrobial therapy at any time up to TOC.|21 to 28 days after completion of study drug therapy|The per protocol population was the main analysis set for the assessment of clinical response and was defined as those subjects with no major protocol deviations that would have influenced the primary outcome.||participants|||Number
743693|NCT00492752|Secondary|Time of Maximum Concentration (Tmax) After 21 Days of Sorafenib Treatment|Tmax refers to the time after dosing when a drug attains its maximum concentration in the blood. It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content. The time corresponding to the highest measurable concentration (Cmax) is referred to as Tmax.|PK assessments made at following times: pre-dose, 1 h, 2h, 4h, 8h,and 12h after at least 21 consecutive doses during Cycle 1|The stated goal in the protocol was to obtain PK data from approximately 39 patients. As this was only descriptive information, the sample size was not critical. All patients who provided PK data were included in the analysis.||hours||Full Range|Median
743694|NCT00492752|Secondary|Normalized Maximum Concentration (Cmaxnorm) After 21 Days of Sorafenib Treatment|Cmaxnorm refers to the maximum plasma concentration of Sorafenib corrected for dose and body weight (Cmaxnorm = Cmax/(mg/kg)).|PK assessments made at following times: pre-dose, 1 h, 2h, 4h, 8h,and 12h after at least 21 consecutive doses during Cycle 1|The stated goal in the protocol was to obtain PK data from approximately 39 patients. As this was only descriptive information, the sample size was not critical. All patients who provided PK data were included in the analysis.||g/mL||Full Range|Geometric Mean
743695|NCT00492752|Secondary|Maximum Concentration (Cmax) After 21 Days of Sorafenib Treatment|Cmax refers to the highest plasma concentration of drug reached after dosing. It is obtained by collecting a series of blood samples after dosing, and analyzing them for drug content by a sensitive and specific analytical method. The highest measured concentration is referred to as the Cmax.|PK assessments made at following times: pre-dose, 1 h, 2h, 4h, 8h,and 12h after at least 21 consecutive doses during Cycle 1|The stated goal in the protocol was to obtain PK data from approximately 39 patients. As this was only descriptive information, the sample size was not critical. All patients who provided PK data were included in the analysis.||mg/L||Full Range|Geometric Mean
743696|NCT00492752|Secondary|Normalized Area Under the Curve (AUC Norm) After 21 Days of Sorafenib Treatment|The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. A plot of concentration vs time after dosing is created, and the area under this curve is calculated by standard methods (eg, trapezoidal rule) to provide a measure of how much drug was in the bloodstream following dosing.|PK assessments made at following times: pre-dose, 1 h, 2h, 4h, 8h,and 12h after at least 21 consecutive doses during Cycle 1|The stated goal in the protocol was to obtain PK data from approximately 39 patients. As this was only descriptive information, the sample size was not critical. All patients who provided PK data were included in the analysis.||g*h/L||Full Range|Geometric Mean
743732|NCT00498706|Primary|Patient Health Questionnaire (PHQ)-9|Measures depression on a 9 - item scale. Scores range from 0-27, with 0 being no symptoms. A difference of 5 or more points on the PHQ-9 is considered a clinically meaningful response to treatment.|Measured at baseline; Weeks 4, 9, 14, and 18; and Months 3, 6 post-treatment follow-up|||units on a scale||Full Range|Mean
743733|NCT00498706|Secondary|Health-related Quality of Life (SF-36V), Patient Satisfaction (Satisfaction Index - Mental Health), and Therapeutic Alliance (Working Alliance Inventory - Short Form)||Measured at baseline; Weeks 4, 9, 14, and 18; and Months 3, 6, 9, and 12 of follow-up||||||
743697|NCT00492752|Secondary|Area Under the Curve From Time 0 to 12 Hours Post-dose (AUC 0-12) After 21 Days of Sorafenib Treatment|The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. A plot of concentration vs time after dosing is created, and the area under this curve is calculated by standard methods (eg, trapezoidal rule) to provide a measure of how much drug was in the bloodstream following dosing.|PK assessments made at following times: pre-dose, 1 h, 2h, 4h, 8h,and 12h after at least 21 consecutive doses during Cycle 1|The stated goal in the protocol was to obtain PK data from approximately 39 patients. As this was only descriptive information, the sample size was not critical. All patients who provided PK data were included in the analysis.||mg*h/L||Full Range|Geometric Mean
743698|NCT00492752|Secondary|Time to Response|Time to Response (TTR) for subjects who achieved a response (Complete Response (CR) or Partial Response (PR) ) was defined as the time from date of randomization to the earliest date that the response was first documented.|From randomization of the first subject until the data cut-off date approximately 23 months after start of randomization|The time to response was measured for the ITT population.||days||Full Range|Median
743699|NCT00492752|Secondary|Duration of Response|Duration of Response was defined as the time from date of first response (Complete Response (CR) or Partial Response (PR)) to the date when Progressive Disease (PD) is first documented, or to the date of death, whichever occurs first. Subjects still having CR or PR at the time of analysis were censored at their last tumor assessment.|From randomization of the first subject until the data cut-off date approximately 23 months after start of randomization|The duration of response was measured for the ITT population.||days||Full Range|Median
743700|NCT00492752|Secondary|Number of Participants With Different Tumor Response|Tumor Response (= Best Overall Response) of a subject was defined as the best tumor response (confirmed Complete Response (CR: disappearance of tumor lesions), confirmed* Partial Response (PR: a decrease of at least 30% in the sum of tumor lesion sizes), Stable Disease (SD: steady state of disease), or Progressive Disease (PD: an increase in the sum of tumor lesions sizes)) observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.|From randomization/start of treatment of the first subject until approximately 23 months after randomization when the subjects on placebo were offered the option to crossover to sorafenib treatment|The tumor response was measured for the ITT population.||participants|||Number
743701|NCT00492752|Secondary|Change in Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) Score From Baseline to Cycle 3 and End of Treatment|"The FACT-Hep questionnaire was also completed to assess patient reported outcome. The FACT-Hep assesses hepatobiliary cancer-related quality of life. FACT-Hep total score ranges from 0 to 180 (0=All questions answered Not at all; 180=All questions answered Very much)."|Baseline up to Cycle 3 and end of treatment. From randomization of the first subject until the data cut-off date approximately 23 months after start of randomization|FACT-Hep score changes from baseline by visit were assessed for the ITT population.||scores on a scale||Standard Deviation|Mean
743702|NCT00492752|Secondary|Change in Functional Assessment of Cancer Therapy (FACT) Hepatobiliary Symptom Index-8 (FHSI-8) Score From Baseline to Cycle 1 and Cycle 3|The FHSI-8 questionnaire was completed at baseline and every 3 weeks during treatment and at the end of treatment visit only for subjects who withdrew for reasons other than symptomatic progression. Patient reported outcome was measured using the FHSI-8 score changes from baseline throughout the study period. FHSI-8 assesses hepatobiliary cancer symptoms with total score ranges from 0 to 32 (0 = the best quality of life; 32 = the worst quality of life with severe symptoms)..|Baseline up to Cycle 1 and Cycle 3. From randomization of the first subject until the data cut-off date approximately 23 months after start of randomization|FHSI-8 score changes from baseline by visit were assessed for the ITT population.||scores on a scale||Standard Deviation|Mean
743703|NCT00492752|Secondary|Disease Control|Disease Control (DC) was defined as the total number of subjects whose best response was not Progressive Disease (PD: an increase in the sum of tumor lesions sizes) according to Response Evaluation Criteria in Solid Tumors (RECIST) (= total number of Complete Response (CR: disappearance of tumor lesions) + total number of Partial Response (PR: a decrease of at least 30% in the sum of tumor lesion sizes) + total number of Stable Disease (SD: steady state of disease); CR, PR, or SD had to be maintained for at least 28 days from the first demonstration of that rating).|From randomization of the first subject until the data cut-off date approximately 23 months after start of randomization|Disease control rate was measured for the ITT population (all randomized subjects)||participants|||Number
743704|NCT00492752|Secondary|Time to Progression (TTP)|Time to progression (TTP) was defined as the time from date of randomization to radiologically documented disease progression. Subjects without progression at the time of analysis were censored at their last date of tumor evaluation。|From randomization of the first subject until the data cut-off date approximately 23 months after start of randomization|Time to progression was measured for the ITT population (all randomized subjects) up to the data cut-off date of 09 Aug 2007 (23 months after randomization).||days||95% Confidence Interval|Median
743705|NCT00492752|Secondary|Time to Symptomatic Progression (TTSP)|Time to Symptomatic Progression (TTSP) was defined as the time from date of randomization to symptomatic progression. Subjects without symptomatic progression at the time of analysis were censored at their last date of tumor evaluation.|From randomization of the first subject until the data cut-off date approximately 23 months after start of randomization|Time to Symptomatic Progression was measured for the ITT population (all randomized subjects) up to the data cut-off date of of 09 Aug 2007 (23 months after randomization)||days||95% Confidence Interval|Median
743706|NCT00492752|Primary|Overall Survival|Overall Survival (OS) was defined as the time from date of randomization to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.|From randomization of the first subject until the data cut-off date approximately 23 months after start of randomization|In this study the overall survival was measured for the ITT population from the date of randomization until the date of death due to any cause. For patients alive or lost to follow-up at the time of analysis, time to death was to be censored at their last date of follow-up, or at the data cut-off of 09 Aug 2007 (23 months after randomization).||days||95% Confidence Interval|Median
743734|NCT00498706|Primary|Number of Participants Who Dropped Out of Therapy|"Using the number of therapy sessions attended, we categorized patients into:
those who discontinued treatment before session 18, and those who completed session 18.
those who discontinued before Session 5, and those who continued."|Post treatment, up to 18 weeks|||participants|||Number
743707|NCT00492856|Primary|3-year Disease-free Survival (DFS) Rate|DFS measured from date of post-consolidation randomization until relapse of any kind or death from any cause. Observation censored at date of last follow-up for patients last known to be alive without report of relapse. Relapse from CR/CRi is occurrence of marrow blasts ≥ 5% or presence of Auer rods or presence of neoplastic promyelocytes; (re)appearance of leukemic blasts or neoplastic promyelocytes in the peripheral blood; or (re)appearance of extramedullary disease. Relapse from PR is sum of marrow blasts and promyelocytes ≥ 20%, or sum of marrow blasts and promyelocytes 6-19% with Auer rods and/or neoplastic promyelocytes; or (re)appearance of leukemic blasts or neoplastic promyelocytes in the peripheral blood; or (re)appearance of extramedullary disease. Relapse from CRc is reappearance of t(15;17) in cytogenetic analysis. Relapse from CRm/PRm is reappearance of PML-RARα by RT-PCR as defined by a normalized quotient > 10^-5 based on RT-PCR performed at appropriate central lab.|Up to 3 years|Eligible patients in molecular remission after receiving consolidation and randomized to either maintenance chemotherapy or observation. As of 8/15/10, all eligible patients were non-randomly assigned to receive maintenance chemotherapy. Only those that were randomized to either maintenance treatment or observation were included.||percentage of patients|||Number
743708|NCT00492856|Secondary|Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug|Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which were deemed to be related to protocol treatment are included. Only adverse events that are possibly, probably, or definitely related to study drug are reported.|Up to 5 years|Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.||Participants|||Number
743709|NCT00498550|Primary|Brief Psychiatric Rating Scale (BPRS) Total Score|This study utilized the 24 item BPRS. Each item is rated a 0 (not present) to 6 (severe) scale. The minimum score for this assessment is 0 and the maximum score is 144.|12 weeks|||BPRS Score||Standard Deviation|Mean
743710|NCT00498550|Primary|Days of Cannabis Use as Measured by the Timeline Followback||12 weeks||||||
743711|NCT00498602|Secondary|Change From Baseline GMTs of Anti-A-beta IgG Subtypes Using ELISA at Visits Where an IgG Total Response is Measurable (at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 if Applicable)|IgG subtypes were not assessed|Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104||||||
743712|NCT00498602|Secondary|GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104|The LLOQ was 50 U/mL and when the assay result was below LLOQ (50 U/mL), 25 U/mL was imputed for IgM.|Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104|The immunogenicity population included all randomized participants with documented injection of at least one dose of study drug and at least one immunogenicity data point collected.||U/mL||95% Confidence Interval|Geometric Mean
743713|NCT00498602|Secondary|Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104|The lower limit of quantification (LLOQ) was 100 U/mL and when the assay result was below LLOQ (100 U/mL), 50 U/mL was imputed for IgG.|Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104|The immunogenicity population included all randomized participants with documented injection of at least one dose of study drug and at least one immunogenicity data point collected.||U/mL||95% Confidence Interval|Geometric Mean
743714|NCT00498602|Primary|Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs)|An AE was any untoward, undesired, or unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study drug or in a sponsor’s clinical study. The event did not need to be causally related to the study drug or the clinical studies. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|approximately 110 weeks, including a 6-week screening period, 52 weeks of dosing and 54 weeks for follow-up after the last dose|The safety population included all randomized participants with documented use of at least one dose of study drug.||percentage of participants|||Number
743715|NCT00498615|Primary|Time to Recover to 70% of Fall in the Baseline Skin Temperature After Cold Challenge.|The time to recover 70% of the drop from baseline (prechallenge) skin temperature was derived for each subject for each cold challenge. After each of 3 study interventions received by each participant. Each participant received Fasudil 4o mg, 80 mg and placebo in a randomized sequence blinded to the participant and researchers.|within 60 minutes|||minutes||Standard Deviation|Mean
743716|NCT00498615|Secondary|The Blood Flow by Laser Doppler Scans of the Fingers|The measurement of the blood flow of participants prior to cold challenge 2 hours after receiving study.|Blood flow prior to cold challenge 2 hours after taking study drug|||perfusion units||Standard Deviation|Mean
743717|NCT00498615|Primary|The Time to Recover 50% of Fall in the Baseline Skin Temperature.|The time to recover 50% of the drop from baseline (prechallenge) skin temperature was derived for each subject for each cold challenge. After each of 3 study interventions received by each participant. Each participant received Fasudil 4o mg, 80 mg and placebo in a randomized sequence blinded to the participant and researchers.|within 60 minutes|||minutes||Standard Deviation|Mean
743735|NCT00498706|Primary|Attrition (Number of Therapy Sessions Attended)|Number of therapy sessions attended was collected. At the end of treatment, the total number of sessions attended by each patient was collected.|Post treatment, up to 18 weeks|A randomized controlled trial of 325 Chicago area primary care patients with major depressive disorder, recruited from November 1007 to December 2010.||Number of Sessions|Participants|Standard Deviation|Mean
743736|NCT00498797|Secondary|Number of Patients With an Objective Disease Progression Event|Number of patients with objective disease progression or death (by any cause in the absence of objective progression)|RECIST tumour assessments carried out at screening and then as per site clinical practice until objective progression. The only additional mandatory tumour assessment visit is at the point of data cut-off (21 July 2007 or up to 7 days in advance of DCO)|||Participants|||Number
743737|NCT00498797|Primary|Prostate Specific Antigen (PSA) Response|Prostate Specific Antigen (PSA) response was defined as a reduction of at least 50% from baseline at any assessment, confirmed by a second assessment 2-4 weeks after the initial response|PSA measurements were to be performed at screening, at baseline (>2 weeks after screening) and every 3 weeks during the study. Any response was to be confirmed 2-4 weeks after the initial assessment of a 50% fall in PSA from baseline|||Participants|||Number
743738|NCT00499252|Secondary|Overall Survival||from entry into the study to death or the date of last contact.|Eligible and Treated Patients||months||95% Confidence Interval|Median
743739|NCT00499252|Secondary|Progression-free Survival|"Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions.
CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response."|from study entry until disease progression, death or date of last contact.|Eligible and Treated Patients||months||95% Confidence Interval|Median
743740|NCT00499252|Primary|Frequency and Severity of Observed Adverse Effects|Refer to Adverse Events (AE) tables.|Every cycle during treatment||||||
743741|NCT00499252|Primary|Tumor Response|"Complete and Partial Tumor Response by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Per RECIST v1.0 for target lesions and assessed by MRIor CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD.
CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response."|every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels|Eligible and Treated Patients||Percentage of participants||95% Confidence Interval|Number
743742|NCT00499343|Primary|CD34+ Cells/kg in Blood Stem Cells|After blood counts return to normal, stem cell collection (takes approximately 4 hours) up to 6 sessions.|The process of stem cell collections take about 4 hours, 1-6 sessions may be needed.|||CD34+ cells/kg||Full Range|Median
743743|NCT00499369|Secondary|Toxicity|Number of patients with Grade 3 through 5 adverse events that are related to study drug. Only adverse events that are possibly, probably or definitely related to study drug are reported.|Up to 5 years|Eligible patients who received any treatment and were assessed for toxicity were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.||Participants|||Number
743744|NCT00499369|Primary|Progression-free Survival (PFS)|PFS is measured from date of registration to first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact.|Up to 5 years|All eligible patients are included in this analysis.||months||95% Confidence Interval|Median
743745|NCT00499369|Secondary|Objective Tumor Response||Up to 5 years|No participants were analyzed due to limited accrual.|||||
743746|NCT00499369|Secondary|Overall Survival|Time to death is from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Up to 5 years|No participants were analyzed due to limited accrual.|||||
743747|NCT00499408|Secondary|Changes in PSA Doubling Time||up to one year||||||
743748|NCT00499408|Secondary|Changes in PSA Slope||up to one year||||||
743749|NCT00499408|Primary|Number of Participants Showing a 50% Reduction in Serum Prostate Specific Antigen(PSA) During Treatment||up to one year|||participants|||Number
743750|NCT00499447|Secondary|Rate of Acute and Late Treatment-related Toxicity (Per CTCAE, v3.0) Related to Specific Symptoms||two years||||||
743751|NCT00499447|Primary|Two Year Progression Free Survival Rate|the number of patients surviving progression-free at two years.|2 years|||participants|||Number
743752|NCT00499460|Secondary|Oral Digoxin Test|Digoxin when given orally is a probe substrate for the efflux activity of P-glycoprotein in the small intestine. The phenotype index in this case is the area under the plasma digoxin concentration from time zero to 240 min after a 0.5-mg oral test dose. A decrease in oral digoxin AUC indicates an enhanced activity of P-glycoprotein, possibly as a result of transporter upregulation.|Serial blood sampling over 4 hours after a 0.5-mg oral test dose of digoxin|||(ng/mL)*min||Standard Deviation|Mean
743753|NCT00499460|Secondary|Oral Midazolam Test|Midazolam when given orally is a probe substrate for the in vivo intestinal and hepatic activity of CYP3A (Cytochrome P450 3A) enzymes. The phenotype index in this case is the area under the plasma midazolam concentration from time zero to 360 min after a 5-mg oral test dose. A decrease in oral midazolam AUC indicates enhanced activity of CYP3A enzymes, possibly as a result of enzyme induction.|Serial blood sampling over 6 hours after a 5-mg oral test dose of midazolam|||(ng/mL)*min||Standard Deviation|Mean
745105|NCT00512902|Secondary|Change in Modified Rodnan Skin Score (MRSS)|No measures of dispersion was available as data were lost. The range of this measure is 0 to 51 and measures the extent of skin thickening with higher numbers representing thickening.|Baseline vs. Endpoint|||units on a scale||Standard Deviation|Mean
743754|NCT00499460|Secondary|Cognitive-Affective Side Effects Total Score|Subjects rated the mental side effects they experienced at 90, 150 and 300 min after oxycodone administration on a 36-item Cognitive-Affective Side Effects (CASE) questionnaire. Total score (i.e., average of the scores for all 36 items) ranges on a numerical scale from 0 (no somatic side effects) to a maximum of 4 (extreme somatic aide effects). Only the peak CASE scores at 150 min are reported herein.|CASE scores at 150 min after a single 15-mg oral dose of oxycodone|||units on a scale||Standard Deviation|Mean
743755|NCT00499460|Secondary|Somatic Side Effects Total Score|Subjects rated the bodily side effects they experienced at 90, 150 and 300 min after oxycodone administration on a 35-item Somatic Side Effects (SSE) questionnaire. Total score (i.e., average of the scores for all 35 items) ranges on a numerical scale from 0 (no somatic side effects) to a maximum of 4 (extreme somatic aide effects). Only the peak SSE scores at 150 min are reported herein.|SSE scores at 150 min after a single 15-mg oral dose of oxycodone|||units on a scale||Standard Deviation|Mean
743756|NCT00499460|Secondary|Cold Pressor Tolerance AUC|Cold Pressor Test measures response to experimentally induced pain, in this case by immersion of a subject's hand in icy-cold water. Tolerance is the duration of time a subject is able to keep his/her hand immersed in the cold water. A prolongation in tolerance time indicates analgesic response to oxycodone treatment. Cold Pressor Tolerance AUC is the area under the tolerance versus time curve over a 300-min period after a test dose of oxycodone. Because of non-normality in sample distribution, log transformed AUC estimates were analyzed by Generalized Linear Model.|Repeated testing for tolerance to Cold Pressor Test just before and at 45, 90, 150 and 300 min after a single 15-mg oral dose of oxycodone|||log (sec*min)||Standard Deviation|Mean
743757|NCT00499460|Primary|Oxycodone Oral Clearance|Oxycodone oral clearance is computed by Dose/AUC, where AUC is the area under the plasma oxycodone concentration-time curve from time zero to infinity. Oral clearance is a measure of the rate at which oxycodone is cleared from the body via metabolism.|Serial blood sampling over 24 hours after a 15-mg oral dose of oxycodone|||L/min||Standard Deviation|Mean
743758|NCT00499473|Secondary|Overall Survival||up to 12 months|||months||Full Range|Median
743759|NCT00499473|Secondary|Percentage of Patients Progression Free at 12 Months||At 12 months after the start of treatment|||percent of patients|||Number
743760|NCT00499473|Secondary|Confirmed Objective Response (Complete Response[CR] or Partial Response [PR])|Confirmatory scans should also be obtained within 4 to 6 weeks following initial documentation of objective response. Confidence intervals for the true proportion will be calculated using the exact binomial method. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|up to 12 weeks|Only 21 patients were evaluable for response||patients|||Number
743761|NCT00499473|Primary|Dose Resulting in Steady-state Trough|Average of pre-dose values of sunitinib + SU12662 plasma concentrations equivalent to that observed in patients not receiving EIAC based on pharmacokinetic modeling.|At baseline (day 8) and days 15, 22, and 23|Not determined due to early termination of the study due to lack of efficacy|||||
743762|NCT00499473|Primary|Maximum Tolerable Dose Based on Dose-limiting Toxicity of Sunitinib in Patients Receiving EIAC (Stratum 2)|Maximum tolerable dose of sunitinib in patients receiving treatment with EIAC agents using dose escalation based on the steady-state trough sunitinib + SU12662 plasma concentrations on day 14 observed in patients treated in stratum 1. Six patients will be treated in each dose cohort with up to 12 patients being treated at the maximum tolerable dose for a total of 18-24 patients with gliomas receiving EIAC.|From the time of first treatment with sunitinib until completion of treatment, assessed up to 30 days|MTD in Stratum 2 not determined due to lack of efficacy in Stratum 1|||||
743763|NCT00499473|Primary|Progression-free Survival at 6 Months (Stratum 1)|Number of patients with Progression-free Survival at 6 months for Stratum 1|From time to registration to up to 6 months|Only 21 patients were evaluable for PFS||patients|||Number
743764|NCT00499486|Primary|Severity of Adverse Events as Assessed by NCI CTCAE v3.0||6 months|||percentage of Adverse Events|||Number
743765|NCT00499486|Primary|Response Rate (Complete, Partial Response and Stable Disease) as Assessed by RECIST|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progression, a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Response for Stable disease was assessed at 2 months and for complete and partial response at 6 months.|response at 2 and 6 months|||participants|||Number
743766|NCT00499486|Primary|Percentage of Patients With Overall Survival at 6 Months||6- month survival rate (6mSR)|||% of participants|||Number
743767|NCT00499590|Secondary|Need for Rescue Therapy, Time to Rescue Therapy, and Number of Patients With a 3 or More Line Gain in Vision||Week 60|Zero participants analyzed due to early termination of the study.|||||
743768|NCT00499590|Primary|Visual Acuity|avoidance of 3 or more lines of vision loss|week 60|Zero participants analyzed due to early termination of the study.|||||
743769|NCT00499603|Secondary|Participant Responses Per Treatment Arm at 24 Weeks|Radiographic criteria of response based on regional ultrasound examination (decrease in size of the primary tumor and/or fatty replacement in regional lymph nodes), and includes partial response and complete response. A decrease in size of the product of the two largest dimensions =/> 50% considered a partial response (PR), and a complete disappearance of the primary tumor by physical exam and or ultrasound and normalization of the lymph nodes by ultrasound will be considered a complete clinical response (CR). Stable Disease (SD) is carcinoma neither decreasing nor increasing in extent or severity, and Progression of disease (PD) defined as 30% increase in size primary tumor and/or lymph nodes on physical exam and/or ultrasound.|24 weeks|Participants who did not complete the entire 12 week of paclitaxel +/- RAD001 or the entire 4 cycles of FEC are evaluable for response.||participants|||Number
743784|NCT00499616|Primary|Comparison Between Reduce Intensity of Therapy for Patients With Stage 4 Neuroblastoma and Favorable Biological Features and Patients < 1 Year of Age With Stage 4 Neuroblastoma Treated on COG-A3961|Addressed by the interim stopping rule and the comparison, by INSS stage, to the historical EFS rate of the analogous cohort of patients < 1 yrs of age.|Up to 3 years|Eligible and evaluable patients with Stage 4 neuroblastoma, 12-18 months of age, and favorable biological features.||percentage of 3 yr EFS rate||95% Confidence Interval|Number
743770|NCT00499603|Secondary|Participant Responses Per Treatment Arm at 12 Weeks|Radiographic criteria of response based on regional ultrasound examination (decrease in size of the primary tumor and/or fatty replacement in regional lymph nodes), and includes partial response and complete response. A decrease in size of the product of the two largest dimensions =/> 50% considered a partial response (PR), and a complete disappearance of the primary tumor by physical exam and or ultrasound and normalization of the lymph nodes by ultrasound will be considered a complete clinical response (CR). Stable Disease (SD) is carcinoma neither decreasing nor increasing in extent or severity, and Progression of disease (PD) defined as 30% increase in size primary tumor and/or lymph nodes on physical exam and/or ultrasound.|12 weeks|Participants who did not complete the entire 12 week of paclitaxel +/- RAD001 or the entire 4 cycles of FEC are evaluable for response.||participants|||Number
743771|NCT00499603|Primary|Number Participants With Inhibition of PI3K/PTEN/AKT Pathway at 48 Hours|Number of participants with inhibition of the PI3K/PTEN/AKT pathway at 48 hours after the start of treatment, regardless of the status of the pathway at the time of randomization. Molecular changes (inhibition/activation) of the PI3K/PTEN/AKT pathway evaluated using reverse phase protein arrays (RPPA) where fine-needle aspirations (FNAs) from the primary breast cancer obtained pretreatment, and at 48 hours. Bioinformatics cluster analysis of arrays used to define molecular changes as inhibition or activation where pathways called 'active' with presence of 2 or more phosphorilated pathway proteins (pAKT, pmTOR, pGSK3, pS6K1, pS6), and 'inhibited' with one or none phosphorilated pathway proteins present.|48 hours after start of treatment|Participants were randomly assigned 1:1 to receive T-FEC or TR-FEC using a balanced block design stratified by disease stage and menopausal status. One participant in Arm 2 started treatment but had untolerable side effects and was taken off the study and thus was considered inevaluable.||participants|||Number
743772|NCT00499616|Secondary|Prognostic Ability of the INRG Image-defined Risk Factor (IDRF) System|A Kaplan – Meier curves of presence vs absence of one or more IDRFs will be generated, and a log rank test performed to compare them, for EFS and OS. The IDRF data will be used to determine the International Neuroblastoma Risk Group Stage (INRGSS) and Kaplan-Meier curves by INRGSS will be generated. To compare the institutional assessment of IDRFs (presence vs absence) with the central review assessment of IDRFs, a chi-square test will be performed. ROC curves will be generated, and the sensitivity and specificity of the institutional assessment will be calculated|At baseline, during and after completion of study treatment||||||
743773|NCT00499616|Secondary|Association Between Surgical Biopsy Technique With Adequacy of Tissue Acquisition for Biologic Studies, and With Complications Associated With the Biopsy Procedure|A chi-square test will be performed.|During and after surgery|The data was not collected to assess this study aim.|||||
743774|NCT00499616|Secondary|Proportion of Patients With Neurologic Symptoms Overall and Type of Symptom|Descriptive analysis will be used.|On treatment and post-treatment||||||
743775|NCT00499616|Secondary|Biological Surrogate Markers|Multivariable analyses will be performed to identify variables of prognostic interest.|At baseline and surgery|The data was not collected to assess this study aim.|||||
743776|NCT00499616|Secondary|Overall Survival Time|Kaplan-Meier curves and life tables of E2FS and OS (from the time of first event) will be generated to describe the outcome for patients who have a first progressive, non-metastatic event during Observation and then receive protocol retrieval therapy.|From the time of the first progressive, non-metastatic event||||||
743777|NCT00499616|Secondary|Second-event-free Survival (E2FS) of Intermediate Risk Patients|Kaplan-Meier curves and life tables of E2FS and OS (from the time of first event) will be generated to describe the outcome for patients who have a first progressive, non-metastatic event during Observation and then receive protocol retrieval therapy.|From the time of the first progressive, non-metastatic event until the subsequent occurrence of relapse, progressive disease, secondary malignancy, or death||||||
743778|NCT00499616|Primary|Correlation Between Extent of Surgical Resection With the Maintenance of Local Control, Surgical Complication Rate|To test for the association of the extent of surgical resection (CR vs <CR) with surgical complications rate (complications of any kind vs no complications at all), a chi-square test will be performed.|Up to 10 years|Eligible and evaluable intermediate risk patients with reported surgery||Proportion with surgical complications||95% Confidence Interval|Number
743779|NCT00499616|Primary|Correlation Between Extent of Surgical Resection With the Maintenance of Local Control, Overall Survival (OS) Rates|To test the predictive ability of the extent of surgical resection for OS, log-rank tests will be performed comparing complete surgical resection vs. without complete surgical resection.|Up to 10 years|Eligible and evaluable intermediate risk patients with reported surgery.||percentage of OS rate||95% Confidence Interval|Number
743780|NCT00499616|Primary|Correlation Between Extent of Surgical Resection With the Maintenance of Local Control, Event Free Survival (EFS)|To test the predictive ability of the extent of surgical resection for EFS, log-rank tests will be performed comparing complete surgical resection vs. without complete surgical resection.|Up to 10 years|Eligible and evaluable intermediate risk patients with reported surgery||percentage of 3 yr EFS survival||95% Confidence Interval|Number
743781|NCT00499616|Primary|Outcome of Patients With Stage 4S Neuroblastoma Who Are Unable to Undergo Biopsy for Biology-based Risk Assignment|Kaplan-Meier curves and lifetables of Event Free Survival (EFS) and Overall Survival (OS) rates will be generated to describe the outcome of the stage 4S infants unable to undergo biopsy.|From baseline to up to 10 years|Eligible and evaluable patients with Stage 4S neuroblastoma unable to undergo biopsy.||percentage survival||95% Confidence Interval|Number
743782|NCT00499616|Primary|Reduced Surgical Morbidity for Patients With Stage 4S Neuroblastoma|Descriptive analyses of the proportion of stage 4S infants that experience a surgical or post-operative event.|Up to 3 years|Eligible and evaluable patients with Stage 4S neuroblastoma that had a biopsy or resection.||Proportion||95% Confidence Interval|Number
743783|NCT00499616|Primary|Comparison Between Reduce Intensity of Therapy for Patients With Unfavorable Histology Neuroblastoma and Patients Unfavorable Histology Neuroblastoma Treated on COG-A3961|Addressed by the interim stopping rule and the comparison, by INSS stage, to the historical EFS rate of the analogous cohort of patients < 1 yrs of age|Up to 3 years|Eligible and evaluable patients with Stage 3 neuroblastoma, 12-18 months of age, MYCN non-amplified, and unfavorable histology.||percentage of 3 yr EFS rate|||Number
745170|NCT00514683|Secondary|Absolute Change From Baseline in FVC|"Change from baseline in percentage of absolute Forced Vital Capacity (FVC) at 52 weeks.
Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline and region."|Baseline and 52 weeks|LOCF-Randomised set||Liters||Standard Error|Mean
743785|NCT00499616|Primary|Definitive Determination of the Prognostic Ability of 1p and 11q|Addressed by a descriptive comparison of the EFS and OS rates for patients with 1p loss vs without 1p loss, and for those with unbalanced 11q vs normal 11q.|At baseline|Eligible intermediate risk patients with 1p and 11q data.||percentage of 3 yr EFS/OS rate||95% Confidence Interval|Number
743786|NCT00499616|Primary|Overall Survival (OS) Rates|OS time is calculated from date of enrollment until death, or until last contact if the patient is alive.|3 years|Eligible intermediate risk patients.||percentage of participants||95% Confidence Interval|Number
743787|NCT00499655|Secondary|Progression-free Survival - Low PGEM|Estimated using the product-limit method of Kaplan and Meier.Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.|Until disease progression, up to 5 years.|Analysis on a subset of patients with low baseline urinary prostaglandin E metabolite (PGEM).||Months||95% Confidence Interval|Median
743788|NCT00499655|Secondary|Progression-free Survival - EGRF|Estimated using the product-limit method of Kaplan and Meier.Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.|Until disease progression, up to 5 years.|Analysis on a subset of patients with wild-type epidermal growth factor receptor (EGFR),||Months||95% Confidence Interval|Median
743789|NCT00499655|Secondary|Progression-free Survival - Elevated PGEM|Estimated using the product-limit method of Kaplan and Meier.Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.|Until disease progression, up to 5 years.|Analysis on a subset of patients with elevated baseline urinary prostaglandin E metabolite (PGEM).||Months||95% Confidence Interval|Median
743790|NCT00499655|Secondary|Number of Participants With Overall Response|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|16 weeks post start of treatment|||Participants|||Count of Participants
743791|NCT00499655|Primary|Progression-free Survival|Estimated using the product-limit method of Kaplan and Meier.Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.|Until disease progression, up to 5 years.|All patients receiving treatment.||Months||95% Confidence Interval|Median
743792|NCT00499681|Primary|Number of Participants With a Pathological Complete Response|Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.|at 14 weeks|Participants who were available for measurement of response.||participants|||Number
743793|NCT00499694|Secondary|Correlation of Urine NTX and Serum BSAP Levels With Time to Progression||Day 1 of every cycle (35 days) and Day 15 of every cycle||||||
743794|NCT00499694|Secondary|Changes in Levels of N-terminal Collagen Peptide (NTX) and Bone-specific Alkaline Phosphatase (BSAP)||Day 1 of every cycle (35 days) and Day 15 of every cycle||||||
743795|NCT00499694|Secondary|Overall Survival||Followed every 3 months after treatment is discontinued||||||
743796|NCT00499694|Secondary|Prostate-specific Antigen (PSA) Response Rate||Day 1 of every cycle (35 days) and Day 15 of every cycle||||||
743797|NCT00499694|Secondary|Toxicity||Day 1 of every cycle (35 days) and Day 15 of every cycle||||||
743798|NCT00499694|Primary|Time to Progression||Every 70 days|||months||90% Confidence Interval|Median
743799|NCT00499863|Secondary|Change From Baseline in Weight at Endpoint||Baseline and endpoint (up to 7 weeks)|Safety population||lbs||Standard Deviation|Mean
743800|NCT00499863|Secondary|Change From Baseline in Diastolic Blood Pressure at Endpoint||Baseline and endpoint (up to 7 weeks)|||mmHg||Standard Deviation|Mean
743801|NCT00499863|Secondary|Change From Baseline in Systolic Blood Pressure at Endpoint||Baseline and endpoint (up to 7 weeks)|Safety population||mmHg||Standard Deviation|Mean
743802|NCT00499863|Secondary|Change From Baseline in Pulse Rate at Endpoint||Baseline and endpoint (up to 7 weeks)|Safety population||bpm||Standard Deviation|Mean
743803|NCT00499863|Secondary|Change From Baseline in Electrocardiogram Results(QTcF Interval) at Endpoint|QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate(e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.|Baseline and endpoint (up to 7 weeks)|Safety population||msec||Standard Deviation|Mean
743804|NCT00499863|Secondary|Dermal Response Scale (DRS) Scores|Mean dermal reaction scores were graded on a scale ranging from 0 (no irritation) to 7 (strong reaction) for observed findings of erythema, edema, papules, and vesicles.|up to 7 weeks|Safety population which included all randomized subjects that received at least one dose of MTS or PTS.||scores on a scale||Standard Deviation|Mean
743805|NCT00499863|Other Pre-specified|Post Sleep Questionnaire (PSQ) Quality of Sleep|Post Sleep Questionnaire (PSQ) overall rating of quality of sleep. There are 5 rating responses ranging from very poor to very good. No numbers are associated with the rating responses.|up to 7 weeks|Safety population (Note: not everyone in the safety population completed a sleep questionnaire)||Participants|||Number
743806|NCT00499863|Secondary|Change From Baseline in Youth Quality of Life-research Version (YQOL-R) Total Score at Endpoint|The Youth Quality of Life Instrument-research version (YQOL-R) is a validated 56-item generic instrument for comparing quality of life of adolescents across condition groups that scores each question on a scale from 0 (never) to 4 (very often).|Baseline and endpoint (up to 7 weeks)|ITT||scores on a scale||Standard Error|Least Squares Mean
772984|NCT00734929|Primary|Cumulative Incidence of Emesis|Any vomiting or retching|48 h|ITT analysis||participants|||Number
743807|NCT00499863|Secondary|Improvement in Parent Global Assessment (PGA) Score|Parent Global Assessment (PGA) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement includes a score of 1 (very much improved) or 2 (much improved) on the scale.|up to 7 weeks|ITT||Participants|||Number
743808|NCT00499863|Secondary|Improvement in Clinical Global Impressions-Improvement (CGI-I) Score|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement includes a score of 1 (very much improved) or 2 (much improved) on the scale.|up to 7 weeks|ITT||Participants|||Number
743809|NCT00499863|Secondary|Change From Baseline in the Conner's Parent Rating Scale-Revised (CPRS-R) Total Score at Endpoint|The Conner's Parent rating Scale-revised short version (CPRS-R) consists of 27 questions graded on a scale from 0 (not true at all) to 3 (very much true).|Baseline and endpoint (up to 7 weeks)|ITT||scores on a scale||Standard Error|Least Squares Mean
743810|NCT00499863|Primary|Change From Baseline in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Endpoint|The Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|baseline and endpoint (up to 7 weeks)|Intent-to-treat (ITT) which included all randomized subjects who received at least one dose of MTS or PTS, and had one Baseline and at least one post-Baseline assessment.||scores on a scale||Standard Error|Least Squares Mean
743811|NCT00499889|Secondary|Participants' With mCR Response to Post Transplant DLI|Number of participants with response of molecular complete remission (mCR) to DLI as treatment for residual disease after transplant. Molecular remission is a complete remission with no evidence of disease in the blood cells and/or bone marrow using sensitive polymerase chain reaction (PCR) tests.|1 year|Only 8 participants having the post-transplant DLI out of the 41 participants treated were analyzed for this outcome.||Participants|||Number
743812|NCT00499889|Primary|Number of Participants in Complete Molecular Remission at 1 Year|Participants at 1 year in molecular remission, post transplant, post imatinib mesylate and donor lymphocyte infusion (DLI). Molecular remission is a complete remission with no evidence of disease in the blood cells and/or bone marrow using sensitive polymerase chain reaction (PCR) tests (this test is most commonly used in clinical trials).|Baseline to 1 year|Analysis was per protocol. One patient did not receive treatment and was excluded from analysis.||participants|||Number
743813|NCT00499889|Secondary|Participants' With mCR Response to Post Transplant Imatinib Mesylate Therapy|Number of participants with response of molecular complete remission (mCR) to Imatinib Mesylate therapy as treatment for residual disease after transplant. Molecular remission is a complete remission with no evidence of disease in the blood cells and/or bone marrow using sensitive polymerase chain reaction (PCR) tests.|1 Year|Analysis was per protocol. Only 19 participants having the post transplant Imatinib Mesylate Therapy out of the 41 participants treated were analyzed for this outcome.||Participants|||Number
743814|NCT00499915|Secondary|Respiratory Morbidity Assessed Through Respiratory Symptoms as Well as Health Care Utilization for Respiratory Illnesses.||2, 5, and 7-9 months post baseline||||||
743815|NCT00499915|Primary|Infants Living in Smoke-free Environments.|"Infants living in homes with a home smoking ban rule"|5 months post baseline|||participants|||Number
743816|NCT00500071|Secondary|Changes From Baseline in Behavior Rating Inventory of Executive Function (BRIEF) Scores at 7 Weeks|Behavior Rating Inventory of Executive Function (BRIEF) is an 86-item questionnaire composed of three scales (Global Executive Composite, Behavioral Recognition Index, and Metacognition Index). Items are rated 1 (never), 2 (sometimes), and 3 (often). Lower scores reflect better functioning.|Baseline and 7 weeks|ITT||Units on a scale||Standard Deviation|Mean
743817|NCT00500071|Secondary|Change From Baseline in Expression and Emotional Scale for Children (EESC) Scores at 7 Weeks|Expression and Emotional Scale for Children (EESC) consists of 29 items rated on a scale from 1 (not true at all) to 5 (very much true). Lower scores reflect better emotional outcomes.|Baseline and 7 weeks|ITT||Units on a scale||Standard Deviation|Mean
743818|NCT00500071|Secondary|Number of Participants With Improvement onParent Global Assessment (PGA)|Parent Global Assessment (PGA) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|7 weeks|ITT||Participants|||Number
743819|NCT00500071|Secondary|Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I)|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 or 2 on the scale.|7 weeks|ITT||Participants|||Number
743820|NCT00500071|Primary|Change From Baseline in Total Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Score at 7 Weeks|Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|Baseline and 7 weeks|Intent-to-treat (ITT). ITT population defined as all subjects who took at least one dose of drug and had at least one ADHD-RS-IV total score available.||Units on a scale||Standard Error|Mean
743821|NCT00500071|Secondary|Weekly Change From Baseline in Total ADHD-RS-IV Score|Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|Baseline and 1, 2, 3, 4, 5, 6, and 7 weeks|ITT||Units on a scale||Standard Error|Mean
743822|NCT00500110|Primary|Number of Participants Achieving Pathological Complete Response|Probability of response, defined as pathological complete remission based on tissue obtained at surgery. Pathological Complete Response (pCR): Patients without gross or microscopic evidence of residual disease at Radical Prostatectomy defined as pCR.|Every 3 months for 1 year, then every 6 months until disease progression or death|Analysis was per protocol.||participants|||Number
743823|NCT00500149|Secondary|Duration of Effect of Vyvanse|Duration of effect will be defined as the first time point at which there is a non-significant difference between Vyvanse and placebo after a time point at which there is a significant difference between the two treatment groups as measured by SKAMP Deportment Scores. The degree of impairment is rated from 0 (normal) to 6 (maximal).|Evaluations were conducted at 1.5, 2.5, 5.0, 7.5, 10.0, 12.0, and 13.0 hours post-dose.|Analysis on intention-to-treat (ITT) population.||scores on a scale||Standard Error|Least Squares Mean
743824|NCT00500149|Primary|Onset of Effect of Vyvanse|The onset of effect will be defined as the first assessment time showing statistical significance between Vyvanse and placebo as measured by the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Deportment scale. The degree of impairment is rated from 0 (normal) to 6 (maximal).|Evaluations were conducted at 1.5, 2.5, 5.0, 7.5, 10.0, 12.0, and 13.0 hours post-dose.|Analysis on the intention-to-treat (ITT) population.||scores on a scale||Standard Error|Least Squares Mean
743825|NCT00500240|Primary|Progression Free Survival (PFS)|PFS was defined as the time interval between the date of complete remission and the date of relapse detection or death. Complete Remission (CR) defined as granulocyte count >1.0 × 10^9/L, platelet count >100 × 10^9/L, no abnormal peripheral blasts, and <5% blasts in normocellular or hypercellular bone marrow.|Date of complete remission to disease progression, assessed for approximately 6 years|There were 51 evaluable participants.||Months||Full Range|Median
743826|NCT00500240|Primary|Overall Survival|Overall survival (OS) defined as the interval between the date of randomization and the date of death. Calculation of period was from baseline (date of randomization) to the death or last follow-up.|Baseline (date of randomization) to date of death or last follow-up (weekly during treatment then every 2 months post study treatment) up to 6 years|||Months|Participants|Full Range|Median
743827|NCT00500240|Primary|1-Year Overall Survival Rate|The overall survival rate defined as percentage of participants in each treatment group who are still alive at 12 months.|1 year|There were 51 evaluable participants.||percentage of participants||95% Confidence Interval|Number
743828|NCT00500266|Primary|Percentage of Participants Taking Pain or Antipyretic Medication|Use of pain or antipyretic medication was collected by the participants using an electronic diary.|Days 1 through 14|Safety population: all participants who received 1 dose of 13vPnC. n = number of participants with the event as “yes” for at least 1 day or as “no” for all days.||Percentage of Participants||95% Confidence Interval|Number
743829|NCT00500266|Primary|Percentage of Participants With Pre-specified Systemic Events|Systemic events were collected by participant using electronic diary. Fatigue,headache,new/aggravated generalized muscle pain,new/aggravated generalized joint pain: any, mild(no interference with activity), moderate(some interference with activity), severe(prevents routine daily activity). Fever(>=38 degrees Celsius[C]), chills, rash, vomiting(mild:1-2 times daily; moderate:>2 times daily; severe:prevents daily activity) decreased appetite & diarrhea(mild:2-3 loose stools/day; moderate:4-5 loose stools/day; severe:>=6 loose stools/day) reported. Participants may be represented in >1 category.|Days 1 through 14|Safety population: all participants who received 1 dose of 13vPnC. n = number of participants with the event as “yes” for at least 1 day or as “no” for all days.||Percentage of Participants||95% Confidence Interval|Number
743830|NCT00500266|Primary|Percentage of Participants With Pre-specified Local Reactions|Local reactions were collected by the participant using an electronic diary. Redness and swelling scaled as any(present); mild(2.5-5.0 centimeters[cm]); moderate(5.1-10.0 cm); severe(>10.0cm). Pain as any(present); mild(present, no interference with activity); moderate(present, some interference with activity); severe(present, prevents daily activity). Limitation of arm movement as any(present); mild(present, could move arm above head); moderate(could move arm above shoulder but not above head); severe(could not move arm above shoulder). Participants may be represented in more than 1 category.|Days 1 through 14|Safety population: all participants who received 1 dose of 13vPnC. n = participants reporting “yes” for at least 1 day or “no” for all days.||Percentage of Participants||95% Confidence Interval|Number
743831|NCT00500292|Primary|Number of Patients With an Objective Disease Progression Event|Number of patients with objective disease progression or death (by any cause in the absence of objective progression)|RECIST tumour assessments carried out at screening and then as per site clinical practice until objective progression. The only additional mandatory tumour assessment visit is at the point of data cut-off (5 March 2008 +/-3 days)|||Participants|||Number
743832|NCT00500318|Secondary|Inspiratory Capacity (IC)/Total Lung Capacity (TLC) Ratio|Ratio of trough Inspiratory Capacity verses Total Lung Capacity.|Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6)|The Intent-to-Treat (ITT) population consisted of all patients in the Safety Population who had at least a baseline and one post-baseline assessment of the primary efficacy parameter. Missing values due to a premature discontinuation or patients who missed specific trial visits were imputed by Last Observation Carried Forward (LOCF).||ratio||Standard Error|Least Squares Mean
743833|NCT00500318|Secondary|Functional Residual Capacity (FRC)|Change in trough Functional Residual Capacity. FRC was assessed at the end of the daily dosing interval (Trough).|Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6)|The Intent-to-Treat (ITT) population consisted of all patients in the Safety Population who had at least a baseline and one post-baseline assessment of the primary efficacy parameter. Missing values due to a premature discontinuation or patients who missed specific trial visits were imputed by Last Observation Carried Forward (LOCF).||L||Standard Error|Least Squares Mean
743834|NCT00500318|Secondary|Trough Inspiratory Capacity (IC)|Change in trough Inspiratory Capacity. Inspiratory Capacity was measured as part of the spirometry procedures performed at each visit. IC was assessed at the end of the daily dosing interval (Trough).|Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6)|The Intent-to-Treat (ITT) population consisted of all patients in the Safety Population who had at least a baseline and one post-baseline assessment of the primary efficacy parameter. Missing values due to a premature discontinuation or patients who missed specific trial visits were imputed by Last Observation Carried Forward (LOCF).||L||Standard Error|Least Squares Mean
743835|NCT00500318|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1)|Change in trough Forced Expiratory Volume in 1 second. FEV1 was assessed at the end of the daily dosing interval (Trough).|Change from baseline (Visit 4) at Week 6 (Visit 6)|The Intent-to-Treat (ITT) population consisted of all patients in the Safety Population who had at least a baseline and one post-baseline assessment of the primary efficacy parameter. Missing values due to a premature discontinuation or patients who missed specific trial visits were imputed by Last Observation Carried Forward (LOCF).||L||Standard Error|Least Squares Mean
743847|NCT00500370|Secondary|Ratio of Endpoint (LOCF) to Baseline for Homeostatic Model Assessment-Insulin Sensitivity (HOMA-S) (Logarithmically Transformed)|Ratio of HOMA-S at week 24 to HOMA-S at week 0 (i.e., HOMA-S at week 24 divided by HOMA-S at week 0). HOMA-S is a measure of insulin sensitivity.|24 weeks|Intent to Treat population; Last Observation Carried Forward||Ratio||Standard Error|Least Squares Mean
747605|NCT00530842|Secondary|Static Lung Volumes|Post-dose RV (Residual Volume) after 8 weeks (measured by bodyphlethysmography)|8 weeks|FAS using imputed values||Litres||Standard Error|Mean
743836|NCT00500318|Primary|Change From Baseline in Exercise Endurance Time (ET)|Exercise endurance time is defined as the time from the increase in work rate at 75% Wmax (watts) to the point of symptom limitation. The Wmax is defined as the highest work rate the patients were able to maintain for at least 30 seconds.|From baseline Week 0 (Visit 4) to Week 6 (Visit 6)|Missing data for patients who withdrew due to COPD exacerbations was imputed using the Worst Observation Carried Forward (WOCF) of all Endurance time (ET), while ETs that were missing for other reasons were imputed using the Last Observation Carried Forward (LOCF) method based on the last visit available.||Seconds||Standard Error|Least Squares Mean
743837|NCT00500357|Secondary|Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2)|Pneumococcal IgG GMCs measured as micrograms per milliliter (mcg/mL) for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMCs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 1 / Year 1 (Core study/NCT00269672), Month 1 / Year 2 (Follow-up study/NCT00500357)|Evaluable Immunogenicity population; N=number of participants with a determinate antibody concentration for the specified serotype.||geometric mean concentration (mcg/mL)||95% Confidence Interval|Geometric Mean
743838|NCT00500357|Secondary|Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1)|Pneumococcal IgG GMCs measured as micrograms per milliliter (mcg/mL) for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMCs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 1 / Year 0 (Core study/NCT00269672), Month 1 / Year 2 (Follow-up study/NCT00500357)|Evaluable Immunogenicity population; N=number of participants with a determinate antibody concentration for the specified serotype.||geometric mean concentration (mcg/mL)||95% Confidence Interval|Geometric Mean
743839|NCT00500357|Secondary|Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2)|Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|Month 1 / Year 1 (Core study/NCT00269672), Month 1 / Year 2 (Follow-up study/NCT00500357)|Evaluable Immunogenicity population; N=number of participants with a determinate antibody titer for the specified serotype.||geometric mean titer||95% Confidence Interval|Geometric Mean
743840|NCT00500357|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3)|Systemic events reported using electronic diary. Fever scaled as Any (≥38 degrees Celsius [C]); Mild (≥38 but <38.5 degrees C); Moderate (≥38.5 but <39 degrees C); Severe (≥39 but ≤40 degrees C); Potentially life-threatening (>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New muscle pain, Aggravated muscle pain, New joint pain, and Aggravated joint pain.|Days 1 through 14 / Year 2 (Follow-up study/NCT00500357)|Safety population; N=number of participants with reactogenicity events (reported Yes for at least 1 day or No for all days); (n)=number of participants with known values for 13vPnC / 23vPS / 13vPnC (Vax 3). Participants may be represented in more than 1 category.||percentage of participants|||Number
743841|NCT00500357|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3)|Local reactions reported using electronic diary. Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters [cm] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (> 10.0 cm). Pain scaled as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move shoulder).|Days 1 through 14 / Year 2 (Follow-up study/NCT00500357)|Safety population included all participants who received the vaccine sequence 13vPnC / 23vPS / 13vPnC. N=number of participants with reactogenicity events (reported Yes for at least 1 day or No for all days); (n)=number of participants with known values for 13vPnC / 23vPS / 13vPnC (Vax 3). Participants may be represented in more than 1 category.||percentage of participants|||Number
743842|NCT00500357|Primary|Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1)|Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|Month 1 / Year 0 (Core study/NCT00269672), Month 1 / Year 2 (Follow-up study/NCT00500357)|Evaluable Immunogenicity population includes participants from the evaluable immunogenicity population for Vax 1 and Vax 2 in the core study/NCT00269672, received 13vPnC in follow-up study/NCT00500357, and had at least 1 assay result in the follow-up study. N=number of participants with a determinate antibody titer for the specified serotype.||geometric mean titer||95% Confidence Interval|Geometric Mean
743843|NCT00500370|Secondary|Change in Glycosylated Hemoglobin (HbA1c)|Change in HbA1c from baseline following 24 weeks of treatment (i.e., HbA1c at week 24 minus HbA1c at week 0)|24 weeks|Intent to Treat population||percent||Standard Error|Least Squares Mean
743844|NCT00500370|Secondary|Change in High Sensitivity C-reactive Protein (hsCRP)|Change in hsCRP levels from baseline following 24 weeks of treatment (i.e., hsCRP at week 24 minus hsCRP at week 0)|24 weeks|Intent to Treat population||pmol/L||Standard Error|Least Squares Mean
743845|NCT00500370|Secondary|Incidence of Patients That Demonstrate Normalization of Impaired Fasting Glucose (IFG) and/or Impaired Glucose Tolerance (IGT)|Number of patients in each treatment group that demonstrate normalization of IFG and/or IGT by week 24|24 weeks|Intent to Treat population||Participants|||Number
743846|NCT00500370|Secondary|Incidence of Patients That Demonstrate Overt Signs of Diabetes Mellitus Diagnosis|Number of patients in each treatment group that demonstrate overt signs of diabetes mellitus diagnosis by week 24|24 weeks|Intent to Treat population||Participants|||Number
791382|NCT00885482|Secondary|Evolution of Atazanavir Plasma Concentrations During the 48 Weeks||48 weeks||||||
743848|NCT00500370|Secondary|Ratio of Endpoint (LOCF) to Baseline for Homeostatic Model Assessment-Beta Cell (HOMA-B) (Logarithmically Transformed)|Ratio of HOMA-B at week 24 to HOMA-B at week 0 (i.e., HOMA-B at week 24 divided by HOMA-B at week 0). HOMA-B is a measure of beta cell function.|24 weeks|Intent to Treat population; Last Observation Carried Forward||Ratio||Standard Error|Least Squares Mean
743849|NCT00500370|Secondary|Change in Serum Glucose AUC Levels Following Oral Glucose Tolerance Test (OGTT)|Change in serum glucose AUC following OGTT (week 24 compared to week 0) (i.e., serum glucose AUC at week 24 minus serum glucose AUC at week 0)|24 weeks|Intent to Treat population; Last Observation Carried Forward||(mmol*hr)/L||Standard Error|Least Squares Mean
743850|NCT00500370|Secondary|Change in Fasting Serum Glucose|Change in fasting serum glucose from baseline following 24 weeks of treatment (i.e., fasting serum glucose at week 24 minus fasting serum glucose at week 0)|24 weeks|Intent to Treat population||mmol/L||Standard Error|Least Squares Mean
743851|NCT00500370|Secondary|Change in Low Density Lipoprotein (LDL) Cholesterol|Change in LDL cholesterol from baseline following 24 weeks of treatment (i.e., LDL cholesterol at week 24 minus LDL cholesterol at week 0)|24 weeks|Intent to Treat population; Last Observation Carried Forward||mmol/L||Standard Error|Least Squares Mean
743852|NCT00500370|Secondary|Ratio of Endpoint (LOCF) to Baseline for Fasting Triglycerides (Logarithmically Transformed)|Ratio of triglycerides at week 24 compared to triglycerides at week 0 (i.e., triglycerides at week 24 divided by triglycerides at week 0)|24 weeks|Intent to Treat population; Last Observation Carried Forward||Ratio||Standard Error|Least Squares Mean
743853|NCT00500370|Secondary|Change in High Density Lipoprotein (HDL) Cholesterol|Change in HDL cholesterol from baseline after 24 weeks of treatment (i.e., HDL cholesterol at week 24 minus HDL cholesterol at week 0)|24 weeks|Intent to Treat population; Last Observation Carried Forward||mmol/L||Standard Error|Least Squares Mean
743854|NCT00500370|Secondary|Change in Total Cholesterol|Change in total cholesterol from baseline after 24 weeks of treatment (i.e., total cholesterol at week 24 minus total cholesterol at week 0)|24 weeks|Intent to Treat population; Last Observation Carried Forward||mmol/L||Standard Error|Least Squares Mean
743855|NCT00500370|Secondary|Percentage of Patients Experiencing >=5% Weight Loss|Percentage of exenatide and placebo treated patients experiencing >=5% weight loss after 24 weeks of treatment (i.e., [weight at week 0 minus weight at week 24] divided by weight at week 0 times 100% >=5%)|24 weeks|Intent to Treat population; Last Observation Carried Forward||percentage of patients|||Number
743856|NCT00500370|Secondary|Change in Waist-to-hip Ratio|Waist-to-hip ratio at week 24 compared to waist-to-hip ratio at week 0 (i.e., waist-to-hip ratio at week 24 minus waist-to-hip ratio at week 0). Waist-to-hip ratio equals waist circumference at given time point divided by hip circumference at given timepoint.|24 weeks|Intent to Treat population||Ratio||Standard Error|Least Squares Mean
743857|NCT00500370|Secondary|Change in Body Mass Index (BMI)|Change in BMI from baseline after 24 weeks of treatment (i.e., BMI at week 24 minus BMI at week 0)|24 weeks|Intent to Treat population||kg/m^2||Standard Error|Least Squares Mean
743858|NCT00500370|Primary|Change in Body Weight|Change in body weight from baseline after 24 weeks of treatment (i.e., body weight at week 24 minus body weight at week 0)|24 weeks|Intent to Treat population||kg||Standard Error|Least Squares Mean
743859|NCT00500448|Primary|Change From Baseline in Quadriceps Strength at 12 Weeks||Baseline and 12 weeks following the intervention|||Nm/kg||95% Confidence Interval|Mean
743860|NCT00500448|Secondary|Change From Baseline in WOMAC Pain Score at 12 Weeks|WOMAC Pain Score ranges from 5 (no pain) to 25 (worst possible pain)|Baseline and 12 weeks following intervention|||units on a scale||95% Confidence Interval|Mean
743861|NCT00500448|Secondary|Change From Baseline in Timed Walking Speed at 12 Weeks||Baseline and 12 weeks post-intervention|||m/s||95% Confidence Interval|Mean
743862|NCT00500448|Secondary|Change From Baseline in WOMAC Disability Score at 12 Weeks|Womac Disability Score is on a scale from 17 (no functional loss) to 85 (severe functional loss)|baseline and 12 weeks post-intervention|||units on a scale||95% Confidence Interval|Mean
743863|NCT00500448|Primary|Change From Baseline in Quadriceps Central Activation Ratio at 12 Weeks|Knee extension Torque recorded during voluntary contraction/Knee extension torque recorded during contraction with superimposed stimulus|Baseline and 12 weeks post-intervention|||unitless||95% Confidence Interval|Mean
743864|NCT00500539|Secondary|Number of Participants Who Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Follow-up Period|The assessment of safety was based on the number of patients with AEs (mild, moderate and severe) and SAEs. According to FDA 21CFR 314.80, a serious adverse event (SAE) is described as any adverse event that leads to death, is life threatening, causes or prolongs hospitalization, results in a congenital anomaly, or any other important medical event not described above. The duration of the follow-up period was 16 weeks, but for purposes of AE reporting the follow-up period was 12 weeks (as the first 4 weeks of follow-up were included in the treatment period).|Last 12 weeks of the follow-up period (initial 4 weeks of the follow-up period were included in the treatment period for AE reporting)|The safety population consisted of all patients that received any part of a dose of study drug and had any post-baseline assessment, whether scheduled or not.||participants|||Number
743865|NCT00500539|Secondary|Number of Participants Who Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Treatment Period|The assessment of safety was based on the number of patients with AEs (mild, moderate and severe) and SAEs. According to FDA 21CFR 314.80, a serious adverse event (SAE) is described as any adverse event that leads to death, is life threatening, causes or prolongs hospitalization, results in a congenital anomaly, or any other important medical event not described above. The duration of the treatment period was 24 weeks, but patients were followed for an additional 4 weeks, so that the total duration of the treatment period for purposes of AE reporting was 28 weeks.|24 weeks treatment period + 4 weeks for following up participants|The safety population consisted of all patients that received any part of a dose of study drug and had any post-baseline assessment, whether scheduled or not.||participants|||Number
743901|NCT00501293|Secondary|Number of Participants With Improvement on Parent Global Assessment (PGA) Scores.|Parent Global Assessment (PGA) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|6 months|ITT||Participants|||Number
745293|NCT00515216|Secondary|Genetic Polymorphisms That May Alter Treatment Outcomes (Partial Response)|This outcome looks at what genotypes of the MDR1 c.3435C>T (rs1045642) gene had a partial response.|4 years|9 out of 25 participants had a partial response.||participants|||Number
743866|NCT00500539|Primary|The Number of Participants With Confirmed Positive Human Antihuman Antibody (HAHA) Results at the End of the 16-week Follow-up Period|An assessment of the immunogenic potential of omalizumab liquid was a primary objective of the study, and was based on the results of the human anti-human antibody (HAHA) assays at the end of the follow-up period. A participant was considered potentially HAHA positive if either Fab or Fc was more than 2.0 titer. All values more than 2.0 titer were re-assayed to obtain a confirmatory result. Confirmatory results were used to determine those participants who were HAHA positive.|16 weeks after last dose|The Safety Population consisted of all patients that received any part of a dose of study drug and had any post-baseline assessment, whether scheduled or not. The analysis was done on total number of patients who had follow-up HAHA sample taken.||participants|||Number
743867|NCT00500578|Primary|Occurrences of Pneumonia|Treatment failure defined as progression to pneumonia within 7 days of initial treatment with aerosolized ribavirin. Patients considered as a failure or to have an unfavorable response if there develop signs and symptoms of pneumonia during therapy either evidenced by chest-xray or clinically, meaning they did reach the primary endpoint.|6 Years|The analysis was carried out per protocol. All patients enrolled were included in the final analysis except one patient who was a screen failure.||Participants|||Number
743868|NCT00500656|Secondary|Time to Almost Complete Symptom Relief|Almost complete symptom relief was defined as a score between 0 and 10 mm on the VAS for at least three consecutive measurements for all symptoms.|48 hours|||Hours||Inter-Quartile Range|Median
743869|NCT00500656|Primary|Time to Onset of Symptom Relief.|"The primary efficacy endpoint was Time to onset of symptom relief (TOSR) following treatment with either icatibant or tranexamic acid. The median time to onset of symptom relief for the icatibant group was compared to the the median time to onset of symptom relief for the tranexamic acid group.
TOSR was defined as the time between time of injection to time of first documented onset of symptom relief for the three primary symptoms: cutaneous swelling, cutaneous skin, and abdominal pain.
The primary symptom was based on the type of attack. For abdominal attacks, the single primary symptom was abdominal pain. For cutaneous attacks, the single primary symptom was either skin swelling or skin pain, whichever was most severe."|2 days|||Hours||Inter-Quartile Range|Median
743874|NCT00500760|Secondary|Percentage of Participants With a Complete Response at 6 Months|Response assessment based on central review of scans using a a modification of the WHO criteria, during the first 6 months. Complete Response is defined as the disappearance of all index and non-index lesions and no new lesions.|6 months|Evaluable for Central Tumor Response Analysis Set||percentage of participants||95% Confidence Interval|Number
743875|NCT00500760|Secondary|Percentage of Participants With an Objective Response at 6 Months|"Objective response by 6 months is defined as a complete response or partial response based on central review of scans using a a modification of the WHO criteria during the first 6 months.
Complete Response (CR): Disappearance of all index and non-index lesions and no new lesions. Partial Response (PR): At least a 50% decrease in the size of index lesions with no progression in non-index lesions, or the disappearance of all index lesions and persistence of 1 or more non-index lesions not qualifying for either CR or progressive disease and no new lesions."|6 months|Evaluable for Central Tumor Response Analysis Set: the subset of participants in the Efficacy Analysis Set with at least one bi-dimensionally measurable lesion at baseline using a modified version of the WHO criteria per blinded central review.||percentage of participants||95% Confidence Interval|Number
743876|NCT00500760|Secondary|Overall Survival|Survival time is defined as time from the first day of any study treatment to date of death. Participants who had not died by the cutoff date were censored at their last contact date.|From first dose date up to 37 months|Efficacy Analysis Set||months||95% Confidence Interval|Median
743877|NCT00500760|Secondary|Progression-Free Survival|"Progression-free survival time is defined as time from the first day of any study treatment to date of first progresive disease using a modified version of the World Health Organization (WHO) criteria or death.
Progressive Disease is defined as at least a 25% increase in the size of index lesions or unequivocal progression of existing non-index lesions or the presence of one or more new lesions.
Participants not meeting these criteria by the cutoff date were censored at their last evaluable disease assessment date."|From first dose date to 37 months|Efficacy Analysis Set||months||95% Confidence Interval|Median
743878|NCT00500760|Secondary|Duration of Local-regional Control|Duration of local regional control is calculated from the first day of any study treatment (radiotherapy, chemotherapy, or panitumumab) administration to the date of first local-regional failure or to death due to any cause (whichever occurs first). Local-regional failure includes persistent disease and local-regional recurrence of disease. Participants who did not meet the criteria for LRC recurrence after achieving a response by the analysis data cutoff date were censored at their last evaluable disease assessment date. Participants who never achieved LRC were considered to have a duration of 0.|From first dose up to 37 months|Efficacy Analysis Set||months||95% Confidence Interval|Median
743879|NCT00500760|Secondary|Local Regional Control Rate at 6 Months and 12 Months|Participants were considered to be in local regional control (LRC) if there was no evidence of active disease in the previously affected/irradiated head-and-neck area. LRC could be achieved at any time following completion of treatment unless disease progression in the local-regional area occurred or the participant received subsequent anti-tumor therapy. Local regional control rate is defined as the Kaplan-Meier (KM) estimate of the proportion of participants with local regional control.|6 months and 12 months|Efficacy Analysis Set||proportion of paticipants||95% Confidence Interval|Number
743902|NCT00501293|Secondary|Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|6 months|ITT||Participants|||Number
743880|NCT00500760|Primary|Local Regional Control Rate at 2 Years|In this study participants were considered to be in local regional control (LRC) if there was no evidence of active disease in the previously affected/irradiated head-and-neck area. LRC could be achieved at any time following completion of treatment unless disease progression in the local-regional area occurred or the participant received subsequent anti-tumor therapy. Local regional control rate is defined as the Kaplan-Meier (KM) estimate of the proportion of participants with local regional control.|2 years|Efficacy Analysis Set (all randomized participants who received at least 1 dose of protocol-specified treatment according to treatment randomization regardless of treatment received.)||proportion of paticipants||95% Confidence Interval|Number
743881|NCT00501007|Secondary|Persistence as a Prospective Predictor of Smoking Cessation|Analysis of Generalized Estimating Equations (GEE) parameter estimates based on empirical standard error estimates, using an exchangeable working correlation structure, with smoking abstinence as outcome variable, and task persistence, time, diagnosis, ability, Fagerstrom Test for Nicotine Dependence (FTND) score, and the interaction between disorder and persistence as explanatory variables.|6 months|||Odds ratio||95% Confidence Interval|Number
743882|NCT00501007|Primary|Mirror-tracing Persistence (in Seconds)|Number of seconds participants continued working on a mirror tracing task before giving up.|baseline|All meeting inclusion criteria||seconds||Standard Deviation|Mean
743887|NCT00501085|Secondary|Subject Reported Sleepiness (Epworth Sleepiness Scale)|The Epworth Sleepiness Scale (ESS) is a questionnaire used to determine a subject’s level of daytime sleepiness. Subjects rate his or her chances of dozing off in different situations, which are combined into a total ESS score that can vary between zero (low level of daytime sleepiness) and 24 (high level of daytime sleepiness).|Baseline to 5 years|The analysis population is defined as all subjects treated with the LAP-BAND System.||units on a scale||Standard Deviation|Mean
743888|NCT00501085|Secondary|Subject Reported Quality of Life|Quality of Life was assessed using the Obesity and Weight-Loss Quality of Life Questionnaire (OWL-QOL-17). The OWL-QOL-17 is a survey of 17 questions, that rates quality of life on a scale of 0 (better) to 102 (lower).|Baseline to 5 Years|The analysis population is defined as all subjects treated with the LAP-BAND System.||units on a scale||Standard Deviation|Mean
743889|NCT00501085|Secondary|Subject Reported Satiety|Subjects rated their level of hunger, satiety after meals, and desire to eat at all follow-up visits. Level of hunger was rated using a 6-point scale: 0 = not hungry at all to 5 = as hungry as I have ever felt. Satiety after meals was rated using a 6-point scale: 0 = not at all full to 5 = as full as I have ever felt. Desire to eat was rated using a 6-point scale: 0 = no desire at all to 5 = extremely strong desire.|Baseline to 5 Years|The analysis population is defined as all subjects treated with the LAP-BAND System.||units on a scale||Standard Deviation|Mean
743890|NCT00501085|Secondary|Subject BMI From Baseline to 5 Years Post LAP-BAND Implantation|Subjects' Body Mass Index (BMI) was recorded at each follow-up visit for the 5 years after LAP-BAND implantation.|Baseline to 5 years|The analysis population is defined as all subjects treated with the LAP-BAND System.||kg/m2||Standard Deviation|Mean
743891|NCT00501085|Primary|Change in Percent Excess Weight|Subjects' Percent Excess Weight Loss (%EWL) from baseline over the 5 year period post LAP-BAND implantation was measured. Excess Weight = Baseline weight - Ideal weight, where ideal weight is based on a BMI of 25 kg/m2.|Baseline to 5 Years|The analysis population is defined as all subjects treated with the LAP-BAND System.||percentage of excess weight lost||Standard Deviation|Mean
743892|NCT00501228|Primary|Number of Donor Derived Cells After G-CSF Therapy|In each patient, the number of donor derived (dd) cells in solid organ tissue specimens measured by biopsy of relevant tissue at initiation of rhG-CSF treatment (baseline) and at eight weeks post allogeneic transplant.|Baseline + 8 Weeks post transplant|No analysis was done. Only one eligible patient was able to complete treatment.|||||
743893|NCT00501293|Primary|Dermal Reactions|Dermal reactions were graded on a scale ranging from 0 (no irritation) to 7 (strong reaction) for observed findings of erythema, edema, papules, and vesicles.|6 months|Safety Population||Participants|||Number
743894|NCT00501293|Primary|Weight||Baseline and 6 months|Safety population||lb||Standard Deviation|Mean
743895|NCT00501293|Primary|Post Sleep Questionnaire (PSQ) Quality of Sleep|Post Sleep Questionnaire (PSQ) overall rating of quality of sleep. There are 5 rating responses ranging from very poor to very good. No numbers are associated with the rating responses.|6 months|Safety Population||Participants|||Number
743896|NCT00501293|Primary|Electrocardiogram Results (QTcF Interval)|QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate(e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.|Baseline and 6 months|Safety Population||msec||Standard Deviation|Mean
743897|NCT00501293|Primary|Pulse Rate||Baseline and 6 months|Safety population||beats per minute||Standard Deviation|Mean
743898|NCT00501293|Primary|Diastolic Blood Pressure||Baseline and 6 months|Safety population||mmHg||Standard Deviation|Mean
743899|NCT00501293|Primary|Systolic Blood Pressure||Baseline and 6 months|Safety population defined as all subjects that received at least one dose of MTS.||mmHg||Standard Deviation|Mean
743900|NCT00501293|Secondary|Change From Baseline in Youth Quality of Life-research Version (YQOL-R) Total Score at 6 Months|The Youth Quality of Life-research version (YQOL-R) is a validated 56-item generic instrument for comparing quality of life of adolescents across condition groups that scores each question on a scale from 0 (never) to 4 (very often). The YQOL scores are transformed to a 0-100 scale for easy interpretability. Higher scores indicate better quality of life.|Baseline and 6 months|ITT. Not all subjects in the ITT population completed a YQOL-R.||Units on a scale||Standard Deviation|Mean
791383|NCT00885482|Secondary|Evolution of Adherence and Quality of Life During the 48 Weeks||48 weeks||||||
743903|NCT00501293|Secondary|Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) at 6 Months|The Conner's Parent rating Scale-revised short version (CPRS-R) consists of 27 questions graded on a scale from 0 (not true at all) to 3 (very much true) with a total score ranging from 0 to 81. Higher scores are indicative of increased ADHD. This scale allows parents to respond on the basis of the child's behavior and help assess ADHD and evaluate problem behavior.|Baseline and 6 months|ITT||Units on a scale||Standard Deviation|Mean
743904|NCT00501293|Secondary|Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Scores at 6 Months|The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|Baseline and 6 months|Intent-to-treat (ITT) defined as subjects who were enrolled and received at least one dose of MTS and had at least one assessment of the primary efficacy endpoint.||Units on a scale||Standard Deviation|Mean
743905|NCT00501345|Primary|Participants With 7 Days Observation Without Severe Bleeding|Blood samples collected at baseline before or after aspirin is given and at 24 hours, 72 hours and 7 days after treatment has been initiated for those that remain in the study after the first 24 hours.|7 Days|The baseline Thromboelastogram showed normal platelet function in all patients and no evidence of heparin induced thrombocytopenia (HIT). No further analysis was done as study was terminated due to lack of accrual.|||||
743906|NCT00501540|Secondary|Overall Survival (OS)|Overall survival for a participant is defined as the number of days from the day of first Lithium administration to the participant's death. As of the time of analysis (03/10/2011), median overall survival duration was not reached.|Up to 4 years|The median OS time had not been reached.||participants||Full Range|Median
743907|NCT00501540|Secondary|Progression Free Survival (PFS)|Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Progression free survival is measured from the date of entry on the study to the appearance of new metastatic lesions or objective tumor progression. If a participant did not experience an event of disease progression or death at the time of analysis (03/10/2011), then the patient's data was censored at the date of the last available evaluation.|Up to 4 years|||months||95% Confidence Interval|Median
743908|NCT00501540|Primary|Tumor Response Rate Measured by the Response Evaluation Criteria in Solid Tumors (RECIST)|Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR) >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) >=20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD), small changes that do not meet the above criteria.|Up to 4 years|||participants|||Number
743909|NCT00501592|Secondary|Hepatocellular Function|Hepatocellular function as measured by assessment of liver enzymes and biochemical markers of hepatic and metabolic function|baseline and 6 weeks|||U/L||Standard Deviation|Mean
743910|NCT00501592|Primary|Insulin Resistance and Glucose Homeostasis|The primary objective of assessing changes in insulin resistance and glucose homeostasis will be attained by performing a euglycemic clamp procedure at baseline (Day 0) and at the end of 6 weeks of treatment (Day 43).|baseline and 6 weeks|||mg/kg/min||Standard Deviation|Mean
743911|NCT00501631|Secondary|Longer-term Safety of VIVITROL|Number of subjects reporting at least 1 treatment-emergent adverse event (TEAE) while on study.|up to 1 year||||||
743912|NCT00501631|Primary|Cumulative Percentage of Participants by Heavy Drinking Rate|"Cumulative percentage (%) of subjects reporting heavy drinking by category reflecting the various cut-offs for percentage of days that were heavy drinking days. A heavy drinking day was defined as 4 or more alcohol drinks in 1 day for women, and 5 or more alcohol drinks in 1 day for men. The Timeline Follow-Back (TLFB) method (Sobell & Sobell: Humana Press, 1992) was utilized to collect subjects' daily drinking information (ie, the number of drinks consumed per day per subject which was retrospectively recalled and recorded in a diary)."|up to 12 weeks|The primary endpoint is based on percentage rate of heavy drinking days during the double-blind treatment period as per protocol.||percentage of participants|||Number
743913|NCT00501644|Primary|Number of Patients With Response|Per World Health Organization (WHO) Tumor Response: Complete Response (CR), Partial Response (PR) or Progressive Disease (PD). CR defined as disappearance of all target lesions, PR as > = 30% decrease in sum of longest dimensions of target lesions with reference baseline sum longest dimensions and if CA 125 levels declined by >50%, provided target lesion size did not increase by >20% on imaging, and PD as >20% increase in sum of longest dimensions of target lesions taking as references smallest sum of longest dimensions recorded since treatment started, or appearance of 1 or > new lesions.|Follow up CT scans after every 3 courses of treatment and following completion of all treatments.|Analysis per protocol. Of 59 participants enrolled, five (5) were not evaluable.||Participants|||Number
743914|NCT00495820|Secondary|Clinical Global Impression|The Clinical Global Impression scale is an observational scale of global evaluation, which assesses the change in degree of illness in relation to the original assessment. The severity sub-scale reported below ranges from 1-7 wherein higher scores indicate worsening severity of illness.|At 12 weeks|||units on a scale||Standard Deviation|Mean
743915|NCT00495820|Secondary|Mini-mental State Examination (MMSE) at 12 Weeks|Mini-mental State Examination (MMSE) is a commonly used screening measure for cognition with questions pertaining to orientation, registration, recall, visuo-spatial construction, attention span etc. Score on MMSE ranges from 0-30, higher scores indicating improving cognition|At 12 weeks|||units on a scale||Standard Deviation|Mean
743916|NCT00495820|Primary|Apathy Evaluation Scale Score at 12 Weeks|The Apathy Evaluation Scale (AES) has been specifically developed to assess apathy and discriminate it from depression. This 18 item scale with score ranging from 18 to 72, assesses apathy in behavioral, cognitive and emotional domains over the previous four weeks. Higher scores indicate worsening apathy.|At 12 weeks|||units on a scale||Standard Deviation|Mean
743917|NCT00501852|Secondary|Least Squares Means of FEV1 (L) at Day 1, by Timepoint|FEV1 was measured at 5, 15, 30 minutes, 1, 2, 3, 4, 5, 23 hours and 15 minutes, and 23 hours and 45 minutes post dose.|Day 1|||Liters||Standard Error|Least Squares Mean
743948|NCT00504556|Secondary|Effects on Pharmacodynamic Biomarker (Endogenous FX Activity) in Subjects Receiving DU-176b|Mean (SD) change from baseline in biomarker endogenous FX activity on Day 28, 1-3 hours post dose.|Day 28|||percent change of Endogenous FX activity||Standard Deviation|Mean
743918|NCT00501852|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) Following 7 Days of Treatment|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. The trough in FEV1 was defined as the mean of two measurements at 23h 15min and 23h 45min post dosing.|Day 7|Modified Intent-to-Treat (mITT) population. The modified intent-to-treat (mITT) population included all randomized patients who received at least one dose of study drug. Patients were analyzed according to the treatment they received.||Liters||Standard Error|Least Squares Mean
743919|NCT00501891|Secondary|Incidence of Grade ≥ 4 Hematologic or Grade ≥ 3 Non-hematologic Toxicity|Number of participants experiencing a grade ≥4 hematologic or grade ≥3 non-hematologic toxicity|27 months|Intent to treat||participants|||Number
743920|NCT00501891|Secondary|Incidence and Severity of CNS Hemorrhage and Systemic Hemorrhage|Number of participants experiencing a Central Nervous System (CNS) hemorrhage or systemic hemorrhage|27 months|Intent to treat||participants|||Number
743921|NCT00501891|Secondary|Response Rate|The number of participants with complete or partial response as determined by a modification of the Macdonald criteria. Complete response was defined as complete disappearance on MR/CT of all enhancing tumor and mass effect, off all corticosteroids (or receiving only adrenal replacement doses), accompanied by a stable or improving neurologic examination, and maintained for at least 4 weeks. Partial Response was defined as greater than or equal to 50% reduction in tumor size on MR/CT by bi-dimensional measurement, on a stable or decreasing dose of corticosteroids, accompanied by a stable or improving neurologic examination, and maintained for at least 4 weeks.|27 months|Intent to treat||Number of participants|||Number
743922|NCT00501891|Primary|6-Month Progression-free Survival|Percentage of participants surviving six months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to the Macdonald criteria, or to death due to any cause. [Optional: Macdonald criteria are standard criteria in neuro-oncology. Tumor assessment was made according to the adapted MacDonald criteria based on the combined evaluation of: 1) assessment of the MRI scan for measurable, evaluable, and new lesions (made by the independent external expert too), 2) overall assessment of neurological performance (made by the investigator), 3) concomitant steroid use (as reported by the investigator).]|6 months|Intent to treat||percentage of participants||95% Confidence Interval|Number
743923|NCT00501943|Secondary|Changes in Normalized Grey Matter Volume|The baseline data of grey matter volume obtained from the MRI images is compared to data obtained at time points using SIENA (Structural Image Evaluation using Normalization of Atrophy) and SIENAX|Baseline, Month-3, Month-6, Month-12 and Month-24|||percent change per year||95% Confidence Interval|Mean
743924|NCT00501943|Secondary|Changes in Symbol Digit Modality Test (SDMT)|Baseline SDMT data were compared to SDMT data collected during the timepoints. A simple substitution task, the SDMT gives the examinee 90 seconds to pair specific numbers with given geometric figures as a measure for screening cognitive impairment. The total score is the total number of correctly completed boxes in the time allowed. The test score range is from 0(worst outcome) to 110 (best outcome).|Baseline, Month-3, Month-6, Month-12, Month-18 and Month-24|||percent change per year||95% Confidence Interval|Mean
743925|NCT00501943|Secondary|Changes in Peripapillary Retinal Nerve Fiber Layer Thickness (RNFL)|Baseline RNFL data is compared to the RNFL data collected during the timepoint, and the changes in RNFL is measured using optical coherence tomography (OCT).|Baseline, Month-3, Month-6, Month-12, Month-18 and Month-24|||percent change per year||95% Confidence Interval|Mean
743926|NCT00501943|Secondary|Changes in MS Functional Composite (MSFC)|Baseline MSFC data is compared to MSFC data collected during the timepoints. The MSFC is a three-part, standardized, quantitative, assessment instrument that measures the clinical dimensions of leg function, arm/hand function and cognitive function and the components include Timed 25-Foot walk, 9-Hole Peg Test and Paced Auditory Serial Addition Test.|Baseline, Month-3, Month-6, Month-12, Month-18 and Month-24|||percent change per year||95% Confidence Interval|Mean
743927|NCT00501943|Secondary|Changes in Normalized White Matter Volumes (nWMV)|The baseline data of white matter volume obtained from the MRI images is compared to data obtained at time points using SIENA (Structural Image Evaluation using Normalization of Atrophy) and SIENAX|Baseline, Month-3, Month-6, Month-12, Month-18 and Month-24|||percent change per year||95% Confidence Interval|Mean
743928|NCT00501943|Primary|MRI Parameter- Percent Brain Volume Change for 2 Years|Baseline MRI is compared to MRI images collected during subsequent timepoints. The percent brain volume change is measured using SIENAX (Structural Image Evaluation using Normalization of Atrophy-X)|Baseline, Month-3, Month-6, Month-12, Month-18 and Month-24|Multivariate regression model was used as the statistical method of analysis for the study. So data from patients who have not completed the study are also used for statistical analysis.||percent change per year||95% Confidence Interval|Mean
743929|NCT00501969|Secondary|Mean Epworth Sleepiness Scale Score During the Open-label Extension|The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire with 8 questions. The total ESS score is the sum of 8 item-scores and can range between 0 and 24. The higher the score, the higher the person's level of daytime sleepiness.|Visit 13 (end of year 1), Visit 17 (end of year 2), Visit 21 (end of year 3), Visit 25(end of year 4)|Of the 395 subjects who entered the study, 395 are included in this summary based on the Safety Set (SS). Last observation carried forward (LOCF) was utilized.||Score on a scale||Standard Deviation|Mean
743930|NCT00501969|Secondary|Number of Subjects Who Withdrew From the Trial Due to an Adverse Event|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|five years|Of the 395 subjects who entered the study, 395 are included in this summary based on the Safety Set (SS).||Subjects|||Number
743931|NCT00501969|Primary|Number of Subjects With at Least One Adverse Event During This Open-label Extension Study|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|five years|Of the 395 subjects who entered the study, 395 are included in this summary based on the Safety Set (SS).||Subjects|||Number
743949|NCT00504556|Secondary|Effects on Pharmacodynamic Biomarker Anti-Factor Xa Activity in Subjects Receiving DU-176b|Mean (SD) change from baseline in biomarker anti-Factor Xa [FXa] activity on Day 28, 1-3 hours post dose.|Day 28|||IU/mL||Standard Deviation|Mean
743950|NCT00504556|Secondary|Pharmacokinetics (AUC) of DU-176b in Subjects Receiving DU-176b|Median (min, max) values of AUCss|3 months|||ng*h/mL||Full Range|Median
743932|NCT00501995|Secondary|Change in the HAQ-DI, PGA, FVC and DLCO|The Health Assessment Questionnaire-Disability Index (HAQ-DI) a 48 item questionnaire assessing ability to perform activities of daily living, use of assistive devises and a 6 item analog scale of pain severity from 0 cm (no pain) to 14.3 cm (very severe pain). The lower the HAQ-DI score the less the disability. The physician global assessment (PGA) which is a visual analogue scale from 0 to 100 on which the physician rates the patient's disease severity based on their observations. A score of 0 is no disease activity and 100 is the worst possible disease activity. The Forced Vital Capacity (FVC) measure of lung capacity and Diffusing Capacity (DLCO) measures of oxygen exchange in the alveoli ( pulmonary function testing). The predicted lung volumes were referenced from NHANES/Hanikson et al and for DLCO predicts were from Knudson. Pre and post study percent predicted values were compared.|0-24 months|The study group consisted of 4 men and 2 women aged 19-60 years of old.||percentage change||Full Range|Mean
743933|NCT00501995|Primary|Improvement in the Modified Rodnan Skin Score.|The modified Rodnan skin score is the accepted clinical measure of scleroderma skin activity. The investigator will assess the thickening of the skin using the modified Rodnan skin score through simple palpation on 17 different body areas: fingers, hands, forearms, arms, feet, legs, and thighs (bilaterally) and face, chest, and abdomen (singly). Skin thickness is assessed on a scale of 0-3; 0 representing normal skin and 3 being severe thickening. The sum of the individual scores can range from 0-51; 0 (normal) to 51 (severe thickening in all 17 areas) A 25% improvement in the modified Rodnan Skin score will be considered significant at any time point in the study. Modified Rodnan Skin Score was evaluated at months 0,1,3,6,12 and 24 months.|0 to 24 months|Patient 4 died during the early phase of the study and longitudinal assessment of his skin score was not determined.||percent improvement from baseline||Full Range|Mean
743934|NCT00504231|Secondary|Assessment of Reactogenicity|Maximum solicited systemic and local signs and symptoms during the week after initial vaccination, by Dose and Randomization Assignment|1 week|||participants|||Number
743935|NCT00504231|Secondary|Geometric Mean Titer (GMT) Pre- and Post- Vaccination|GMT before and 4 Weeks after Vaccination by Full- or Reduced-Dose (9 mg) IM or Reduced-Dose (9 mg) ID Injections. A/Solomon Islands/3/2006 (A/H1N1), A/Wisconsin/67/2005 (A/H3N2), B/Malaysia/2506/2004 (B)|1 month|||GMT||95% Confidence Interval|Geometric Mean
743936|NCT00504231|Primary|Seroprotection Pre- and Post- Vaccination|Seroprotection before and 4 Weeks after Vaccination by Full- or Reduced-Dose (9 mg) Intramuscular (IM) or Reduced-Dose (9 mg) Intradermal (ID) Injections for A/Solomon Islands/3/2006 (A/H1N1), A/Wisconsin/67/2005 (A/H3N2), B/Malaysia/2506/2004 (B)|1 month|||% of Participants|||Number
743937|NCT00504257|Secondary|Overall Survival (OS)|Overall Survival (OS): defined as observed length of life from entry onto the protocol to death, or for living patients, date of last contact (regardless of whether or not this contact is on a subsequent protocol). Survival (PFS and OS) were analyzed using the Kaplan-Meier method with standard errors based on Greenwood's formula.|Up to 5 years|All evaluable participants||months||95% Confidence Interval|Median
743938|NCT00504257|Secondary|Occurrence of Grade 3 or 4 Toxicity|Number of participants with Grade 3 or 4 Toxicity based on 278 treatment cycles. Toxicity was graded per the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|Up to 4 years|All evaluable participants||participants|||Number
743939|NCT00504257|Secondary|Overall Response Rate (RR)|Overall Response: Complete Response (CR) + Partial Response (PR). To determine the response rate (RR) of the investigational treatment regimen. Response and progression were evaluated in the study by using the Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) method or modified Rustin Criteria for CA-125 measurements.|Up to 5 years|Response Rate (RR) evaluable patients included all patients who received at least 2 cycles of treatment and at least one tumor assessment or had demonstrated clinical progression.||participants|||Number
743940|NCT00504257|Secondary|Median Progression Free Survival|"PFS: Period from study entry until disease progression, death due to disease progression, or date of last contact.
Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started, progression of non-target lesions, or the appearance of one or more new lesions."|Up to 5 years|All evaluable participants||months||95% Confidence Interval|Median
743941|NCT00504257|Primary|Six Month Progression Free Survival (PFS)|"Percentage of participants with PFS at six months. PFS: Period from study entry until disease progression, death due to disease progression, or date of last contact.
Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started, progression of non-target lesions, or the appearance of one or more new lesions."|6 months per participant|All evaluable participants||percentage of participants||95% Confidence Interval|Number
743942|NCT00504426|Secondary|Improvement Rate of Pain (Doctor's Judgment)|"Percentage of participants qualified for improvement of pain by doctor's judgement.
Qualification: stopped or almost stopped, alleviated, slightly alleviated, unchanged, worsend.
Improvement defind by stopped or almost stopped or alleviated."|Baseline and Week 4|||Percentage of Participants||95% Confidence Interval|Number
743943|NCT00504426|Primary|Pain (Subjective Symptom)|"Change of pain measured by 100 mm visual analogue scale (VAS) at week4 from baseline.
Regarding VAS (dotted onto a 100 mm line), 0 mm means No Pain and 100 mm means Worst Pain Imaginable."|Baseline and Week 4|||mm||Standard Deviation|Mean
743944|NCT00504504|Primary|5-year Failure-free Survival Rate for Participants With Hodgkin's Disease Given Rituximab With ABVD|Five year Event Free Survival (EFS) is proportion of surviving participants who remain event free out of total participants at 5 years after receiving Rituximab + ABVD (RABVD). Event-free Survival (EFS) analyzed every 6 months.|Baseline to 5 Years or until disease progression|||percentage of participants|||Number
743945|NCT00504556|Secondary|Effects on Pharmacodynamic Biomarker INR in Subjects Receiving DU-176b|Mean (SD) change from baseline in biomarker International Normalized Ratio (INR) on Day 28, 1-3 hours post dose.|Day 28|||ratio||Standard Deviation|Mean
743946|NCT00504556|Secondary|Effects on Pharmacodynamic Biomarker PT in Subjects Receiving DU-176b|Mean (SD) change from baseline in biomarker prothrombin time (PT) on Day 28, 1-3 hours post dose.|Day 28|||seconds||Standard Deviation|Mean
743947|NCT00504556|Secondary|Effects on Pharmacodynamic Biomarker PICT Activity in Subjects Receiving DU-176b|"Mean (SD) change from baseline in biomarker prothrombinase induced clotting time [PICT] on Day 28, 1-3 hours post dose.
PICT was determined by PICT aasay which is a plasma based functional assay to determine the anticoagulant activity on FXa and FIIa inhibition."|Day 28|||seconds||Standard Deviation|Mean
743956|NCT00504556|Secondary|Incidence of Major Adverse Cardiac Events MACE)|MACE is defined as the composite of stroke [ischemic or hemorrhagic], Systemic embolic event (SEE), Myocardial Infarction (MI), Cardiovascular (CV) death, and hospitalization for any cardiac condition|3 months|safety analysis set||percent of subjects experiencing events||95% Confidence Interval|Number
743957|NCT00504595|Secondary|Efficacy of ACZ885 (Canakinumab) by Assessing the Response to Treatment Using the Disease Activity Score (DAS28)|DAS28 is derived by the number of swollen joints and tender joints using the 28-joint count (tender28 and swollen28). DAS28 measures the C-reactive protein (CRP) (in mg/L) and the patient's general health (GH). GH is measured on a 100 mm Visual Analogue Scale (VAS), ranging from no arthritis activity to maximal arthritis activity. DAS28 = 0.56*√(tender28) + 0.28*√(swollen28) + 0.36*log_e(CRP+1) + 0.014*PGDA + 0.96. Lower scores indicate less disease activity.|6 weeks and 12 weeks|The Safety Analysis Set consisted of all subjects who received at least one dose of study medication. The analysis used last observation carried forward (LOCF) imputation for missing values.||Scores on a scale||Standard Deviation|Mean
743958|NCT00504595|Secondary|Efficacy of ACZ885 by Assessing the Response to Treatment Using the Simple Disease Index (SDAI)|SDAI is derived by the number of swollen joints and tender joints using the 28-joint count (tender28 and swollen28). SDAI measures the high sensitivity C-reactive protein (hsCRP) level, patient's global disease activity (PGDA) and evaluator's global disease activity (EGDA). PGDA and EGDA are measured on a 100 mm Visual Analogue Scale (VAS), ranging from no arthritis activity to maximal arthritis activity. SDAI = tender28 + swollen28 + CRP + (PGDA/10) + (EGDA/10). Lower scores indicate less disease activity.|6 weeks and 12 weeks|The Safety Analysis Set consisted of all subjects who received at least one dose of study medication. The analysis used last observation carried forward (LOCF) imputation for missing values.||Scores on a scale||Standard Deviation|Mean
743959|NCT00504595|Primary|Response to Treatment (ACR20) in Adult Patients With Established Rheumatoid Arthritis (RA)|"At each post-dose visit, an ACR20 responder was defined as someone who achieved at least 20% improvement in the tender and the swollen 28-joint count, and 20% improvement in at least 3 of the following 5 measures::
Patient's pain assessment (Visual Analogue Scale (VAS) 100 mm)
Patient's global assessment of disease activity (VAS 100 mm)
Physician's global assessment of disease activity (VAS 100 mm)
Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)
Acute phase reactant (high sensitivity C-reactive Protein (hsCRP))"|6 weeks and 12 weeks|The Safety Analysis Set consisted of all subjects who received at least one dose of study medication. The analysis used last observation carried forward (LOCF) imputation for missing values.||Participants|||Number
743960|NCT00504660|Primary|6 Month Progression-free Survival for Participants With Glioblastoma|Progression-free Survival (PFS) at 6 months measured as percentage of participants that are alive and progression-free at 6 months (glioblastoma multiforme). A combination of neurological examination and MRI brain scan used to define overall response or progression.|6 months|||percentage of participants|||Number
743961|NCT00504660|Primary|12 Month-progression-free Survival for Participants With Anaplastic Tumors|Progression-free Survival (PFS) at 12 months measured as percentage of participants that are alive and progression-free at 12 months (anaplastic tumors). A combination of neurological examination and MRI brain scan used to define overall response or progression.|12 months|Results from TMZ and CCNU treatment arms (Anaplastic Tumor-Glioma Arms 1 & 2) were combined in the final analysis because there was no statistically significant difference between them.||percentage of participants|||Number
743962|NCT00504725|Secondary|Verbal Pain Scores|Pain scores rated by the subject on a scale of 0 low - 10 high|baseline, 4 hours, 24 hours and at discharge|||units on a scale||Standard Deviation|Mean
743963|NCT00504725|Secondary|C-reactive Protein (CRP) Serum Levels|The CRP levels were measured 24 hours postoperatively.|24 hours|||pg/ml||Standard Deviation|Mean
743964|NCT00504725|Primary|Interleukin Levels at 24 Hours||24 Hours|||pg/ml||Standard Deviation|Mean
743965|NCT00504751|Primary|Complete Response|Complete Response|26 months|||participants|||Number
743966|NCT00504777|Secondary|Change From Baseline in HAQ-DI Score|The Stanford HAQ-DI is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Responses in each component set are scored from 0 (without any difficulty) to 3 (unable to do). The highest score recorded for any question in a category determines the score for the category, unless aids, devices, or help from another person is required. The HAQ-DI score is calculated as the sum of the category scores divided by the number of categories scored, giving a possible range of scores from 0 to 3. Scores of 0 to 1 are generally considered to represent “mild to moderate difficulty”, 1 to 2 as “moderate to severe disability”, and 2 to 3 as “severe to very severe disability”.|Week 24|ITT Population||scores on a scale||Standard Deviation|Mean
743967|NCT00504777|Secondary|Percentage of Participants Achieving a Response by European League Against Rheumatism (EULAR) Category|Percentage of participants with a EULAR response at Week 24 based on a scale of good response, moderate response, or no response. The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders have a change from baseline greater than (>)1.2 with DAS28 less than or equal to (≤)3.2; moderate responders have a change from baseline >1.2 with DAS28 >3.2 to ≤5.1 or change from baseline >0.6 to ≤1.2 with DAS28 ≤5.1; non-responders have a change from baseline ≤0.6 or change from baseline >0.6 and ≤1.2 with DAS28 >5.1.|Week 24|ITT Population||percentage of participants|||Number
743968|NCT00504777|Secondary|Percentage of Participants Achieving American College of Rheumatology (ACR) Response|ACR20/50/70 response defined as greater than or equal to (≥)20 percent (%), 50%, or 70% improvement, respectively, in TJC and SJC, and ≥20%/50%/70% improvement in at least 3 of 5 remaining ACR core measures: Patient Assessment of Pain, Patient Global Assessment of Disease Activity, Physician Global Assessment of Disease Activity, self-assessed disability based on the Health Assessment Questionnaire-Disability Index (HAQ-DI), and C-Reactive Protein (CRP).|Week 24|ITT Population||percentage of participants|||Number
744076|NCT00506350|Primary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (From Day 0 up to Month 24)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Participants|||Count of Participants
743969|NCT00504777|Primary|Change From Baseline in Disease Activity Score Based on 28-Joint Count (DAS28)|DAS28 was calculated from the number of swollen joints, or swollen joint count (SJC) and tender joint count (TJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (measured in millimeters per hour [mm/hr]), and Patient Global Assessment of Disease Activity (participant rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. A clinically significant improvement in DAS28 was a change of at least 1.2 units.|Week 24|ITT Population||scores on a scale||Standard Deviation|Mean
743970|NCT00504881|Secondary|Change From Baseline to the 16-week Treatment Period in Medication Effects Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into 7 multi-item subscales: Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items), and a Health Status item. In addition to the 31 items of the QOLIE-31, the QOLIE-31-P contains 7 items asking the subjects to rate the degree of 'distress' related to the topic of each subscale (ie, distress items). The QOLIE-31-P also contains an item asking about the relative importance of each subscale topic (ie, prioritization item). The subscale scores, the total score and the Health Status item score were calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function.|Baseline to 16-week Treatment Period|"Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.
Only subjects who are not mentally impaired were to complete the QOLIE-31-P. Only subjects having values at baseline and at the considered visit are included."||units on a scale||Standard Deviation|Mean
743971|NCT00504881|Secondary|Change From Baseline to the 16-week Treatment Period in Overall Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into 7 multi-item subscales: Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items), and a Health Status item. In addition to the 31 items of the QOLIE-31, the QOLIE-31-P contains 7 items asking the subjects to rate the degree of 'distress' related to the topic of each subscale (ie, distress items). The QOLIE-31-P also contains an item asking about the relative importance of each subscale topic (ie, prioritization item). The subscale scores, the total score and the Health Status item score were calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function.|Baseline to 16-week Treatment Period|"Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.
Only subjects who are not mentally impaired were to complete the QOLIE-31-P. Only subjects having values at baseline and at the considered visit are included."||units on a scale||Standard Deviation|Mean
743972|NCT00504881|Secondary|Change From Baseline to the 16-week Treatment Period in Cognitive Functioning Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into 7 multi-item subscales: Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items), and a Health Status item. In addition to the 31 items of the QOLIE-31, the QOLIE-31-P contains 7 items asking the subjects to rate the degree of 'distress' related to the topic of each subscale (ie, distress items). The QOLIE-31-P also contains an item asking about the relative importance of each subscale topic (ie, prioritization item). The subscale scores, the total score and the Health Status item score were calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function.|Baseline to 16-week Treatment Period|"Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.
Only subjects who are not mentally impaired were to complete the QOLIE-31-P. Only subjects having values at baseline and at the considered visit are included."||units on a scale||Standard Deviation|Mean
743973|NCT00504881|Secondary|Change From Baseline to the 16-week Treatment Period in Emotional Well-being Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into 7 multi-item subscales: Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items), and a Health Status item. In addition to the 31 items of the QOLIE-31, the QOLIE-31-P contains 7 items asking the subjects to rate the degree of 'distress' related to the topic of each subscale (ie, distress items). The QOLIE-31-P also contains an item asking about the relative importance of each subscale topic (ie, prioritization item). The subscale scores, the total score and the Health Status item score were calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function.|Baseline to 16-week Treatment Period|"Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.
Only subjects who are not mentally impaired were to complete the QOLIE-31-P. Only subjects having values at baseline and at the considered visit are included."||units on a scale||Standard Deviation|Mean
743989|NCT00504881|Secondary|Seizure Frequency (All Seizure Types) Per Week Over the 16-week Treatment Period|"There are three different types of seizures:
Type I: Partial seizures
Type II: Generalized seizures
Type III: Unclassified epileptic seizures. All seizure frequency per week over Treatment Period (TP) was calculated as: (Total number of seizures over the TP)*7/(Total number of days with no missing seizure count in the TP)"|Baseline (Week 0) to the end of Treatment Period (Week 16)|Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.||number of seizures per week||Inter-Quartile Range|Median
772985|NCT00734968|Primary|Incidence of Post-operative UTI in Treatment Group|The incidence of UTI in the nitrofurantoin group was 17.6%.|6 weeks|||participants|||Number
743974|NCT00504881|Secondary|Change From Baseline to the 16-week Treatment Period in Energy/Fatigue Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into 7 multi-item subscales: Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items), and a Health Status item. In addition to the 31 items of the QOLIE-31, the QOLIE-31-P contains 7 items asking the subjects to rate the degree of 'distress' related to the topic of each subscale (ie, distress items). The QOLIE-31-P also contains an item asking about the relative importance of each subscale topic (ie, prioritization item). The subscale scores, the total score and the Health Status item score were calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function.|Baseline to 16-week Treatment Period|"Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.
Only subjects who are not mentally impaired were to complete the QOLIE-31-P. Only subjects having values at baseline and at the considered visit are included."||units on a scale||Standard Deviation|Mean
743975|NCT00504881|Secondary|Investigator's Global Evaluation Scale (I-GES) Evaluated at Last Visit or Early Discontinuation Visit|The Investigator's Global Evaluation Scale (I-GES) is a global assessment of the disease evolution which was performed using a seven-point scale (1= Marked worsening to 7= Marked improvement) with the start of the study medication as the reference time point. The Investigator completed it by answering to the following: 'Assess the overall change in the severity of patient's illness, compared to start of study medication.'|Baseline to Last Visit or Early Discontinuation Visit in the 16-week Treatment Period|"Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.
Evaluable subjects are subjects for whom the GES was completed by the investigator at last treatment period visit."||units on a scale||Standard Deviation|Mean
743976|NCT00504881|Secondary|Patient's Global Evaluation Scale (P-GES) Evaluated at Last Visit or Early Discontinuation Visit|The Patient's Global Evaluation Scale (P-GES) is a global assessment of the disease evolution which was performed using a seven-point scale (1= Marked worsening to 7= Marked improvement) with the start of the study medication as the reference time point. The subject completed it by answering to the following: 'Overall, has there been a change in your seizures since the start of the study medication?'|Baseline to last visit or early discontinuation visit in the 16-week Treatment Period|"Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.
Evaluable subjects are subjects who completed the GES at last treatment period visit."||units on a scale||Standard Deviation|Mean
743977|NCT00504881|Secondary|Change From Baseline to the 16-week Treatment Period in Hospital Depression Score|The Hospital Anxiety and Depression Scale (HADS) was used to evaluate Anxiety and Depression.The HADS was developed as a self-administered scale to assess the presence and severity of Anxiety and Depression. It consists of 14 items that are scored on a 4-point severity scale ranging from 0 to 3. A score per dimension was calculated with each score ranging from 0 to 21 (higher scores indicating greater problems). A negative value in change from Baseline indicates an improvement from Baseline.|Baseline to 16-week Treatment Period|"Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.
Only subjects who are not mentally impaired were to complete the HADS. Only subjects having values at baseline ans at the considered visit are included."||units on a scale||Standard Deviation|Mean
743978|NCT00504881|Secondary|Change From Baseline to the 16-week Treatment Period in Hospital Anxiety Score|The Hospital Anxiety and Depression Scale (HADS) was used to evaluate Anxiety and Depression. The HADS was developed as a self-administered scale to assess the presence and severity of Anxiety and Depression. It consists of 14 items that are scored on a 4-point severity scale ranging from 0 to 3. A score per dimension was calculated with each score ranging from 0 to 21 (higher scores indicating greater problems). A negative value in change from Baseline indicates an improvement from Baseline.|Baseline to 16-week Treatment Period|"Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.
Only subjects who are not mentally impaired were to complete the HADS. Only subjects having values at baseline ans at the considered visit are included."||units on a scale||Standard Deviation|Mean
743979|NCT00504881|Secondary|Change From Baseline to the 16-week Treatment Period in Daily Activities / Social Functioning Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into 7 multi-item subscales: Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items), and a Health Status item. In addition to the 31 items of the QOLIE-31, the QOLIE-31-P contains 7 items asking the subjects to rate the degree of 'distress' related to the topic of each subscale (ie, distress items). The QOLIE-31-P also contains an item asking about the relative importance of each subscale topic (ie, prioritization item). The subscale scores, the total score and the Health Status item score were calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function.|Baseline to 16-week Treatment Period|"Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.
Only subjects who are not mentally impaired were to complete the QOLIE-31-P. Only subjects having values at baseline and at the considered visit are included."||units on a scale||Standard Deviation|Mean
743990|NCT00504881|Secondary|Responder Rate for Partial Onset Seizures (Type I) Frequency Per Week Over the 16-week Treatment Period|The responder rate was presented as the percentage of responders and non-responders. A subject is a responder, if the subject has at least 50 % reduction in Partial Onset Seizure frequency per week from Baseline to Treatment Period. Subjects with zero seizure frequency per week at Baseline were considered as non-responders.|Baseline (Week 0) to the end of Treatment Period (Week 16)|Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.||percentage of participants|||Number
743980|NCT00504881|Secondary|Change From Baseline to the 16-week Treatment Period in Seizure Worry Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into 7 multi-item subscales: Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items), and a Health Status item. In addition to the 31 items of the QOLIE-31, the QOLIE-31-P contains 7 items asking the subjects to rate the degree of 'distress' related to the topic of each subscale (ie, distress items). The QOLIE-31-P also contains an item asking about the relative importance of each subscale topic (ie, prioritization item). The subscale scores, the total score and the Health Status item score were calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function.|Baseline to 16-week Treatment Period|"Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.
Only subjects who are not mentally impaired were to complete the QOLIE-31-P. Only subjects having values at baseline and at the considered visit are included."||units on a scale||Standard Deviation|Mean
743981|NCT00504881|Secondary|Change From Baseline to the 16-week Treatment Period in Total Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into 7 multi-item subscales: Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items), and a Health Status item. In addition to the 31 items of the QOLIE-31, the QOLIE-31-P contains 7 items asking the subjects to rate the degree of 'distress' related to the topic of each subscale (ie, distress items). The QOLIE-31-P also contains an item asking about the relative importance of each subscale topic (ie, prioritization item). The subscale scores, the total score and the Health Status item score were calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function.|Baseline to 16-week Treatment Period|"Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.
Only subjects who are not mentally impaired were to complete the QOLIE-31-P. Only subjects having values at baseline and at the considered visit are included."||units on a scale||Standard Deviation|Mean
743982|NCT00504881|Secondary|Time to Tenth Type I Seizure During Treatment Period|Time to tenth Type I seizure during the 16-week Treatment Period was measured in days.|Baseline to 16-week Treatment Period|Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.||days||95% Confidence Interval|Median
743983|NCT00504881|Secondary|Time to Fifth Type I Seizure During the 16-week Treatment Period|Time to fifth Type I seizure during the 16-week Treatment Period was measured in days.|Baseline to 16-week Treatment Period|Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.||days||95% Confidence Interval|Median
743984|NCT00504881|Secondary|Time to First Type I Seizure During the 16-week Treatment Period|Time to first Type I seizure during the 16-week Treatment Period was measured in days.|Baseline to 16-week Treatment Period|Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.||days||95% Confidence Interval|Median
743985|NCT00504881|Secondary|Reduction of Type IC/Type I Seizure Frequency Ratio From Baseline to the 16-week Treatment Period|The type IC/Type I seizure frequency ratio is represented by the percentage of subjects having a reduction in the ratio of Type IC seizure frequency over Type IA, IB, and IC seizure frequency from Baseline to Treatment Period.|Baseline to 16-week Treatment Period|"The Intention-to-treat (ITT) population was defined as all randomized subjects who received at least 1 dose of study medication.
Type IC Population consists of those subjects with at least one Type IC seizure during the Baseline period."||percentage of participants|||Number
743986|NCT00504881|Secondary|Seizure Freedom Rate (All Seizure Types) Over the 16-week Treatment Period|"Subjects were considered seizure free if their seizure counts for every day over the Treatment Period (TP) was zero and if they did not discontinue before the end of the TP. Seizure freedom rate was calculated as:
(total number of seizure - free subjects in treatment group during TP)/(total number of evaluable Intent-To-Treat (ITT) subjects in treatment group)"|Baseline (Week 0) to the end of Treatment Period (Week 16)|Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.||percentage of participants|||Number
743987|NCT00504881|Secondary|Categorized Response From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 16-week Treatment Period|"Subjects were classified in 1 of the following categories based on their percent reduction from Baseline to Treatment Period in Partial Onset Seizure (POS) frequency per week: <-25 %, -25 % to <25 %, 25 % to <50 %, 50 % to <75 %, 75 % to <100 %, and 100 %.
Subjects having zero for Baseline seizure frequency per week were classified in the <-25 % category."|Baseline to 16-week Treatment Period|Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.||percentage of participants|||Number
743988|NCT00504881|Secondary|Percent Change From Baseline to the 16-week Treatment Period in Partial Onset Seizure (Type I) Frequency Per Week|"Percent change from Baseline was calculated as percent reduction by:
(weekly seizure frequency Baseline - weekly seizure frequency Treatment)*100/(weekly seizure frequency Baseline).
A negative value in percent Change from Baseline indicates an improvement from Baseline.
The higher the negative values for percent change in Partial Onset Seizure (POS) frequency, the higher the improvement from Baseline."|Baseline (Week 0) to end of Treatment Period (Week 16)|Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.||percent change||Inter-Quartile Range|Median
744120|NCT00506662|Secondary|Change in Mean Pre-dinner Plasma Glucose at Month 4||week 0, month 4|Due to the recruitment issue, the trial has been prematurely interrupted and the final number of patients does not allow any efficacy analysis.|||||
791384|NCT00885482|Secondary|Evolution of CD4 Cell Count During the 48 Weeks||48 weeks||||||
743991|NCT00504881|Primary|Partial Onset Seizure (Type I) Frequency Per Week Over the 16-week Treatment Period|"Partial (Type I) seizures can be classified into one of the following three groups:
Simple partial seizures
Complex partial seizures
Partial seizures evolving to generalized tonic-clonic convulsions.
Partial Onset Seizure (POS) frequency per week over the Treatment Period (TP) was calculated as:
(Total Type I seizures over the TP)*7/(Total number of days with no missing seizure count in the TP)"|Baseline (Week 0) to the end of the Treatment Period (Week 16)|Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.||seizures per week||Inter-Quartile Range|Median
743992|NCT00504881|Primary|Percentage of Subjects With at Least One Adverse Event During the 16-week Treatment Period|An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|Week 2 to the end of the Treatment Period (Week 16)|The Safety Population was defined as all randomized subjects who received at least 1 dose of study medication.||percentage of participants|||Number
743993|NCT00504894|Primary|New Encoding (Scanner) Task Reaction Time (ms)|The encoding task was performed in the scanner. Subjects viewed a pseudorandom sequence of 160 images, made up of the 40 negative–arousing targets and 40 neutral targets, each presented twice (mean interval between first and second presentations 9.1 images). The task was to indicate with the buttonpress device whether the image they were seeing was being presented for the first time (‘new’) or whether it had been presented earlier in the sequence (‘old’). The sequence was divided into eight blocks of 20 images, with a short break in between blocks. The interstimulus interval was jittered to an average of 12 s (range 6–18 s). Images were presented for 3000 ms and separated by a white fixation cross. For counterbalancing, four versions of the sequence were randomly assigned. The entire encoding task took ∼35 min, after which the drug was stopped and the subject removed from the scanner.|for 90 minutes after the drug/placebo was commenced|||ms||Standard Error|Mean
743994|NCT00504985|Primary|Patient Fatigue Severity Scores Assessed With MDASI|"Descriptive factor and cluster analysis using MD Anderson Symptom Index (MDASI) 13 core symptom items to form 1) treatment-related factor (nausea and vomiting) and 2) general severity factor (the remaining 11 core symptom items). Patients rate intensity and interference of symptoms on 0–10 numeric scales from not present to as bad as you can imagine. Patients also rate the amount of interference with daily activities caused by symptoms on 0–10 numeric scales from did not interfere to interfered completely."|Survey and blood draw done within 24 hours of patient's Emergency Center visit|Study terminated early due to low recruitment, insufficient data for analysis.|||||
743995|NCT00505076|Secondary|Schizophrenia Cognition Rating Scale (SCoRS) Score|The Schizophrenia Cognition Rating Scale (SCoRS) assessed functional capacity. The SCoRS Interviewer Global Rating of function has a range 1 to 10. Higher ratings indicate greater impairment.|4 Weeks (Baseline to End of Treatment)|Fifty-three participants completed the study: MK-0777 3mg BID: 18; MK-0777 8mg BID: 18; placebo: 17. Three participants dropped out prior to receiving study drug (one randomized to each group) and 1 participant dropped out prior to any post-randomization ratings (randomized to placebo). These participants were not included in analyses.||SCoRS Score||Standard Deviation|Mean
743996|NCT00505076|Secondary|UPSA(UCSD Performance-Based Skills Assessment) Summary Score|The UCSD Performance-Based Skills Assessment assessed functional capacity. The UPSA Summary Score has a range from 0 to 120. A higher score indicates less impairment.|Baseline and end of treatment, a total of four weeks.|Fifty-three participants completed the study: MK-0777 3mg BID: 18; MK-0777 8mg BID: 18; placebo: 17. Three participants dropped out prior to receiving study drug (one randomized to each group) and 1 participant dropped out prior to any post-randomization ratings (randomized to placebo). These participants were not included in analyses.||UPSA Summary Score||Standard Deviation|Mean
743997|NCT00505076|Primary|Composite MATRICS Consensus Cognitive Battery Score|The primary outcome measure is the composite score on the Matrics Consensus Cognitive Battery (MCCB). The MCCB composite score is a standardized mean of the seven domain scores. T-scores are standardized to normative data, and have an estimated mean of 50 and SD of 10 in the general healthy population. Data reduction for analysis of neurocognitive testing used the following steps: i) individual neurocognitive test scores at baseline and follow-up were converted to t-scores; ii) t-scores within the pre-specified cognitive domains measured by more than one test were averaged to obtain a domain-specific t-score; and iii) domain-specific t-scores were averaged to create the MCCB composite score.|4 weeks|Fifty-three participants completed the study: MK-0777 3mg BID: 18; MK-0777 8mg BID: 18; placebo: 17. Three participants dropped out prior to receiving study drug (one randomized to each group) and 1 participant dropped out prior to any post-randomization ratings (randomized to placebo). These participants were not included in analyses.||composite score||Standard Deviation|Mean
743998|NCT00505284|Secondary|Analysis of Rescue Analgesic Medication Use (Acetaminophen) During Double-Blind Dosing Period|If acetaminophen was not reported on the Pain Therapy CRF or on the Concomitant Medication CRF, it was assumed that the subject did not use rescue analgesic medication.|Baseline to Week 15|ITT Population||Participants|||Number
743999|NCT00505284|Secondary|Presence or Absence of Allodynia at Week 15/EOT|Investigators rated subjects’ allodynia as mild, moderate, severe, or not present. The presence of allodynia (yes/no) at Week 15/EOT was analyzed.|Week 15/EOT|ITT Population||Participants|||Number
744000|NCT00505284|Secondary|Withdrawal Due to Treatment Failure During Double-Blind Dosing Period|Based on data reported on the End of Study case report form (CRF): If a subject terminated the study early during the Double-blind Dosing Period due to ‘lack of therapeutic efficacy,’ the subject was counted as a withdrawal due to treatment failure.|Baseline and Week 15|ITT Population||Participants|||Number
744001|NCT00505284|Secondary|Change From Baseline to Week 15/EOT in Hospital Anxiety and Depression Scale (HADS) Anxiety and Depression Subscale Scores|HADS anxiety subscale score=sum of scores for 7 anxiety items, each scored on a 4-pt scale (0, 1, 2, or 3), where a higher score indicates worse anxiety. Range of possible HADS anxiety subscale scores, 0 to 21. HADS depression subscale score=sum of scores for 7 depression items, each scored on a 4-pt scale (0, 1, 2, or 3), where a higher score indicates worse depression. Range of possible HADS depression subscale scores, 0 to 21.|Baseline and Week 15/EOT|ITT Population||Scores on a Scale||Standard Deviation|Mean
744002|NCT00505284|Secondary|Change From Baseline to Week 15/EOT in SF-36 Physical and Mental Component Scores|Short Form 36 Health Survey Questionnaire (SF-36) measuring limitations in Physical Components including physical activities, usual role activities (due to physical problems), measuring bodily pain, general health perceptions, and Mental Components including social activities, usual role activities (due to emotional problems), vitality (energy and fatigue. Each of the 8 domains are described by a score ranging from 0 to 100, for a range of total possible scores of 0-400 for physical and 0-400 for mental. Higher scores reflect better subject status.|Baseline and Week 15/EOT|ITT Population||Scores on a Scale||Standard Deviation|Mean
744003|NCT00505284|Secondary|Analysis of Patient Global Impression of Change (PGIC) at Week 15/EOT|At the EOT (Visit 7) or Early Withdrawal Visit (as appropriate), the subject assessed his/her status compared to how they felt before entering the study. This assessment included an evaluation of pain frequency and intensity, the occurrence of AEs, and overall functional status using a 7-point scale where 1=very much improved and 7=very much worse. Using Modified BOCF.|Week 15/EOT|Subset of ITT population used, including subjects that completed PGIC at Week 15 visit, and using BOCF (baseline observation carried forward) subjects that terminated prior to Week 15 received a 'No Change' if due to AE or Lack of Therapeutic Efficacy, subjects who discontinued due to other reasons used PGIC scores from Early Termination visit.||Participants|||Number
744004|NCT00505284|Secondary|Change in Short Form - McGill Pain Questionnaire (SF-MPQ) From Baseline to Week 15/EOT|SF-MPQ sensory score = sum of intensity scores for descriptors 1-11 (throbbing, shooting, stabbing, sharp, cramping, gnawing, hot-burning, aching, heavy, tender, splitting). Each descriptor scored as 0=none, 1=mild, 2=moderate, or 3=severe. Range of possible sensory scores, 0 to 33, with a score of 33 being the most severe intensity.|Baseline and Week 15/EOT|ITT Population||Scores on a Scale||Standard Deviation|Mean
744005|NCT00505284|Secondary|Change in Average Sleep Interference Scores From Baseline to Week 15/EOT|Average of last 7 available scores prior to the visit, based on 11-point Likert-type numerical rating scale for sleep interference (0=pain did not interfere with sleep, to 10=pain completely interfered with sleep [unable to sleep]). Based on modified BOCF.|Baseline to Week 15/EOT|ITT Population||Scores on a Scale||Standard Deviation|Mean
744006|NCT00505284|Primary|Mean Change in Average Pain Scores From Baseline at Each Study Week|Average pain scores were calculated as the average of last 7 available scores prior to the visit, based on 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain). Last on-treatment value refers to last 7 days of available diary data while subject was on double-blind study drug.|Baseline, Week 1 to Week 17|ITT Population||Scores on a Scale||Standard Deviation|Mean
744007|NCT00505284|Primary|Responder Rate: Analysis of the Change in Pain Score From Baseline to Week 15/EOT in Subjects Who Had at Least a 50% Reduction in Pain Score|Average pain scores were calculated as the average of last 7 available scores prior to the visit, based on 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain). This is based on a modified BOCF.|Baseline to Week 15/EOT|ITT Population. A responder was defined as a subject who had at least a 50% reduction in average pain scores from Baseline to Week 15/EOT.||Percentage of Participants|||Number
744008|NCT00505284|Primary|Responder Rate: Analysis of the Change in Pain Score From Baseline to Week 15/EOT in Subjects Who Had at Least a 30% Reduction in Pain Score|Average pain scores were calculated as the average of last 7 available scores prior to the visit, based on 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain). This is based on a modified BOCF.|Baseline to Week 15/EOT|ITT Population. A responder was defined as a subject who had at least a 30% reduction in average pain scores from Baseline to Week 15/EOT.||Percentage of Participants|||Number
744009|NCT00505284|Primary|Change in Average Pain Scores From Baseline to Week 15/End of Treatment (EOT)|Average of last 7 available scores prior to the visit, based on 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain). This is based on a modified baseline observation carried forward (BOCF).|Baseline to Week 15/EOT|Intent-to-Treat (ITT) Population - Randomized subjects who took at least 1 dose of study drug and had at least 1 efficacy assessment at Baseline.||Scores on a Scale||Standard Deviation|Mean
744010|NCT00505362|Secondary|Operative Times|Operative time of the cesarean delivery in minutes.|From start to the end of the cesarean delivery, assessed up to two hours.|||minutes||Standard Deviation|Mean
744011|NCT00505362|Primary|Post-operative Pain|Post-operative pain was assessed using Silverman Integrated Assessment (SIA) pain score which combines the opioid use and movement pain score over the 72-hour study period. The SIA pain and opioid score is calculated by first rank ordering each patient’s total opioid use (morphine milligram equivalents) and area under the curve (AUC) movement pain score over the 72 hour study period, then calculating a mean for both opioid use and movement pain scores, expressing both opioid use and movement pain score as percent differences from the mean, and lastly adding the percent differences from the mean for the two variables. The SIA composite score value for each subject ranges from approximately 200% to approximately -200%, with the highest positive score indicating the least comfortable or the most pain despite the greatest use of analgesics, and the lowest score indicating the most comfortable or least pain despite the least use of analgesics.|72-hour study period|||Scores on a scale||Standard Deviation|Mean
744012|NCT00505375|Primary|Area Under the Stimulated C-peptide Curve Over the First 2 Hours of a 4 Hour Mixed Meal Tolerance Test at the 2 Year Visit|The primary outcome is the area under the stimulated C-peptide curve (AUC) based on data collected at time 0 to 2 hours of a 4-hour mixed meal glucose tolerance test (MMTT) conducted at the primary endpoint visit. The timed measurements are done at: 0, 15, 30 60, 90, and 120 minutes.|2 years of follow up|||nmol/L||95% Confidence Interval|Geometric Mean
744013|NCT00505414|Secondary|Patient Global Impression of Change (PGIC)|The Patient Global Impression of Change (PGIC) is an instrument where the participant indicates their perceived change at the end of a treatment phase. The overall participant status assessed using Patient Global Impression of Change (PGIC) self-assessment questionnaire which was used by participants to report on 7 categories listed as follows; Very Much Improved, Much Improved, Minimally Improved, No Change, Minimally Worse, Much Worse and Very Much Worse in tapentadol and morphine at Day 15 (Start of Maintenance Phase) and repeated in participants completing the Maintenance Phase in the Matching Placebo, Tapentadol and Morphine (Day 43).|Day 15 corresponds with PGIC at end of titration phase; Day 43 corresponds with PGIC at end of maintenance phase|Full Analysis Set. Number of participants with data available.||participants|||Number
772986|NCT00734968|Primary|Incidence of Post-operative UTI in Placebo Group|The incidence of UTI in the placebo group was 32%.|6 weeks|||participants|||Number
744014|NCT00505414|Primary|Responder Rates in Maintenance Period|"A responder is a participant in the study that:
completed 28 days of the maintenance phase
had a numeric rating scale score below 5 on the 11 point scale (where 0 indicates no pain and 10 indicates worst possible pain. This twice daily current pain score was averaged over Day 18 to Day 43.
did not use more than 30 mg of rescue medication per day on average in the 28 day (excluding the first 3 days) maintenance period (from Day 18 to Day 43).
A participant that met all 3 of the above-mentioned criteria is counted as a responder, in other words the participant benefited from the assigned drug treatment. A participant that fails to meet at least 1 of the 3 criteria is not counted as a responder."|End of the 4 week Maintenance Phase (Day 43)|Full Analysis Set. Number of participants with data available.||participants|||Number
744015|NCT00505518|Primary|Nurse Telepsychiatry Services Satisfaction Questionnaire|The charge nurse’s satisfaction with the telepsychiatry services were surveyed using a satisfaction questionnaire specifically designed for this study. The satisfaction questionnaire is a scale with three choices: “not satisfied”, “satisfied”, and “highly satisfied.”|30 days or 60 days (length depended on clinical needs of patients)|||Participants|||Number
744016|NCT00505518|Primary|Patient/Family Telepsychiatry Service Satisfaction Survey|Patients’ (or their family members’ for those who had severe cognitive deficits) satisfaction with the telepsychiatry services were surveyed using a satisfaction questionnaire specifically designed for this study. The satisfaction questionnaire is a scale with three choices: “not satisfied”, “satisfied”, and “highly satisfied.”|30 days or 60 days (length depended on clinical needs of patients)|||participants|||Number
744017|NCT00505518|Primary|Change in Mean Scores on Clinical Global Impressions|Minimum score - 1 (better outcome) Maximum score - 7 (worse outcome)|Baseline, 30 days or 60 days (length depended on clinical needs of patients)|||units on a scale||Standard Deviation|Mean
744018|NCT00505622|Secondary|Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) During Open-label Extension Study|ON state is when medication is providing benefits with regard to stiffness, slowness, and tremor. All data was collected using a 3-day diary within a window of a defined visit.|Baseline, Week 0, Week 2, Week 4, Week 8, Week 20, Follow-up|Safety population||Hours||Standard Deviation|Mean
744019|NCT00505622|Secondary|Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) During Open-label Extension Study|Unified Parkinson’s Disease Rating Scale (UPDRS) is a standardized assessment of the symptoms and signs of Parkinson’s Disease. Part III assesses motor activity, based on 14 items, such as gait, facial expression, and rigidity. Participants receive a score of 0-4 points per item, with a higher score indicating more severe symptoms. ON state is when medication is providing benefits to stiffness, slowness, and tremor.|Baseline, Week 0, Week 20, Week 32|Safety population||Scores on a scale||Standard Deviation|Mean
744020|NCT00505622|Secondary|Mean Change From Baseline in UPDRS Part II (ADL) Score in OFF State (Hours) During Open-label Extension Study|Unified Parkinson’s Disease Rating Scale (UPDRS) is a standardized assessment of the symptoms and signs of Parkinson’s Disease. Part II assesses activities of daily living (ADL) based on 13 items, such as speech, hygiene, and falling. Participants receive a score of 0-4 points per item, with a higher score indicating more severe symptoms. OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor.|Baseline, Week 0, Week 20, Week 32|Safety Population||Scores on a scale||Standard Deviation|Mean
744021|NCT00505622|Primary|Mean Change From Baseline in Total Daily OFF Time (Hours) During Open-label Extension Study|OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor. All data was collected using a 3-day diary within a window of a defined visit.|Baseline, Week 0, Week 2, Week 4, Week 8, Week 20, Follow-up|Safety Population - All subjects entering the open-label extension study who took at least 1 dose of perampanel.||Hours||Standard Deviation|Mean
744022|NCT00505635|Secondary|Number of Participants With Response|Response evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST).|Following each 21 day cycles||||||
744023|NCT00505635|Primary|Time to Progression (TTP)|TTP defined as the time from date of first dose of study medication to first documentation of objective tumor progression in days. Response evaluation by Response Evaluation Criteria in Solid Tumors (RECIST) done following 2 cycles and 3 cycles. Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline.|Following two 21 day cycles until disease progression|||days||Full Range|Geometric Mean
744024|NCT00505661|Primary|Objective Response Rate Following Treatment With Letrozole|Using RECIST criteria, Objective Response evaluated every 2 months.|2 month intervals for first 2 years|Analysis was per protocol, only 9 of 12 eligible patients were evaluable for response.||participants|||Number
744025|NCT00505687|Secondary|Mean Epworth Sleepiness Scale Score During the Open-label Extension.|The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire with 8 questions. The total ESS score is the sum of 8 item-scores and can range between 0 and 24. The higher the score, the higher the person's level of daytime sleepiness.|Visit 6 (post year 1), Visit 10 (post year 2), Visit 14 (post year 3), End of Treatment (last study visit or early withdrawal visit)|Of the 186 subjects who entered the study, 186 are included in this summary based on the Safety Set (SS). Last observation carried forward (LOCF) was utilized.||Score on a scale||Standard Deviation|Mean
744026|NCT00505687|Secondary|Number of Subjects Who Withdrew From the Trial Due to an Adverse Event|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|four years|Of the 186 subjects who entered the study, 186 are included in this summary based on the Safety Set (SS).||Subjects|||Number
744027|NCT00505687|Primary|Number of Subjects With at Least One Adverse Event During This Open-label Extension Study|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|four years|Of the 186 subjects who entered the study, 186 are included in this summary based on the Safety Set (SS).||Subjects|||Number
744028|NCT00505752|Secondary|Percentage of Participants With Clinical Pregnancy|Clinical pregnancy was defined as the presence of one or more fetal sacs with fetal heart activity on the Day 35-42 post r-hCG ultrasound examination.|Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 21 days])|ITT population included all the participants who were randomized to study treatment. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.||Percentage of participants|||Number
744029|NCT00505752|Primary|Number of Fertilized Oocytes (2 Pronuclei [PN])|Oocytes were fertilized using Intra-cytoplasmic Sperm Injection (ICSI) technique which is an in-vitro fertilization procedure in which a single sperm is injected directly into an egg under a microscope. The appearance of 2PN is the first sign of successful fertilization as observed during in vitro fertilization, and is usually observed after ICSI. The zygote is then termed 2PN.|Ovum pick-up (OPU) day (34-38 hours post r-hCG administration day [end of stimulation cycle {approximately 21 days}])|Intention-to-treat (ITT) population included all the participants who were randomized to study treatment. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.||2PN oocytes||Standard Deviation|Mean
744030|NCT00505765|Secondary|Change in SCoRS Interviewer Global Rating|Schizophrenia Cognition Rating Scale (SCoRS) assessed functional capacity by completing a 20-question rating scale via interviews with the subject and an informant, focusing on cognitive impairment and its impact on daily functioning. After the interview, the interviewer rated subject's overall difficulty on a Global Scale of 1-10. Higher scores indicate greater cognitive impairment.|Baseline, 12 weeks|Participants administered SCoRS at both Baseline and 12 weeks were included in analysis||units on a scale||Standard Deviation|Mean
744031|NCT00505765|Secondary|Change in SCoRS Interviewer Global Rating|Schizophrenia Cognition Rating Scale (SCoRS) assessed functional capacity by completing a 20-question rating scale via interviews with the subject and an informant, focusing on cognitive impairment and its impact on daily functioning. After the interview, the interviewer rated subject's overall difficulty on a Global Scale of 1-10. Higher scores indicate greater cognitive impairment.|Baseline, 6 weeks|Participants administered SCoRS at both Baseline and 6 weeks were included in analysis||units on a scale||Standard Deviation|Mean
744032|NCT00505765|Secondary|Change in UCSD Performance-Based Skills Assessment (UPSA) Summary Scores|UPSA includes 5 skill areas (subscales) with scores that each range from 0-20. The UPSA yields an overall total score which is the sum of the five subscales and ranges from 0-100. Higher scores are associated with more independent living.|Baseline, 12 weeks|Only participants with UPSA scores at both Baseline and 12 weeks were included in this analysis||units on a scale||Standard Deviation|Mean
744033|NCT00505765|Secondary|Change in UCSD Performance-Based Skills Assessment (UPSA) Summary Scores|UPSA includes 5 skill areas (subscales) with scores that each range from 0-20. The UPSA yields an overall total score which is the sum of the five subscales and ranges from 0-100. Higher scores are associated with more independent living.|Baseline, week 6|Only participants with UPSA scores at both Baseline and 6 weeks were included in this analysis||units on a scale||Standard Deviation|Mean
744034|NCT00505765|Primary|Change in MATRICS Consensus Cognitive Battery (MCCB)|The MATRICS Consensus Cognitive Battery (MCCB) measures functioning across various cognitive domains and is comprised of ten tests that assess seven cognitive domains (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition) Its measurements are based on timed paper-and-pencil, computerized, and orally-administered tests, as well as spatial tests using geometric cubes. MCCB composite T scores are between 40 and 60 (normal range) and < 40 (below normal range).|Baseline, 12 weeks|Only participants with completed MCCB at both Baseline and 12 weeks were included in analysis||units on a scale||Standard Deviation|Mean
744035|NCT00505765|Primary|Change in MATRICS Consensus Cognitive Battery Composite Score Change|The MATRICS Consensus Cognitive Battery (MCCB) measures functioning across various cognitive domains and is comprised of ten tests that assess seven cognitive domains (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition) Its measurements are based on timed paper-and-pencil, computerized, and orally-administered tests, as well as spatial tests using geometric cubes. MCCB composite T scores are between 40 and 60 (normal range) and < 40 (below normal range).|Baseline, week 6|Only participants with completed MCCB at both baseline and 6 weeks were included in analysis||units on a scale||Standard Deviation|Mean
744036|NCT00505778|Secondary|Percentage of Participants Indicating Ulcerative Colitis in Remission (Patient Defined Remission Index), ITT Population, Month 6|Is your ulcerative colitis in remission (not active)? Y/N|6 months|ITT Population||Percentage of Participants|||Number
744037|NCT00505778|Secondary|Total MARS (Medication Adherence Report Scale) Questionnaire Scores, ITT Population, Month 6|MARS: Composite score for the following statements: I change how many times per day I take my medicine, I forget to use it, I stop taking it for a while, I only use it when I am having active symptoms, I decide to miss out on a dose, I take less than instructed, I take more than instructed, I avoid using it if I can, I use it regularly every day (reverse scored): 5-never, 4-rarely, 3-sometimes, 2-often, 1-very often. Minimum score 9, maximum score 45.|6 months|ITT Population||MARS Score||Standard Error|Mean
744038|NCT00505778|Secondary|Number of Subjects Who Relapse/Flare Within 6 Months, ITT Population|Relapse/flare is defined as SCCAI >= 5. Simple Clinical Colitis Activity Index: minimum score 0, maximum score 19, reflects disease activity over the 24 hours prior to completion. Composite Score: bowel frequency (day, 0-3) (night, 0-2), defecation urgency (0-3), blood in stool (0-3), general well being (0-4), extracolonic features (arthritis, pyoderma gangrenosum, erythema nodosum, uveitis - 1 per manifestation).|6 months|ITT Population||Participants|||Number
744039|NCT00505778|Secondary|Percentage of Patients Remaining in Remission at Month 12, ITT Population|Remission defined as SCCAI score < 5. Simple Clinical Colitis Activity Index: minimum score 0, maximum score 19, reflects disease activity over the 24 hours prior to completion. Composite Score: bowel frequency (day, 0-3) (night, 0-2), defecation urgency (0-3), blood in stool (0-3), general well being (0-4), extracolonic features (arthritis, pyoderma gangrenosum, erythema nodosum, uveitis - 1 per manifestation).|12 months|ITT Population||Percentage of Participants|||Number
744040|NCT00505778|Secondary|Percentage of Patients Remaining in Remission at Month 3, ITT Population|Remission defined as SCCAI < 5. Simple Clinical Colitis Activity Index: minimum score 0, maximum score 19, reflects disease activity over the 24 hours prior to completion. Composite Score: bowel frequency (day, 0-3) (night, 0-2), defecation urgency (0-3), blood in stool (0-3), general well being (0-4), extracolonic features (arthritis, pyoderma gangrenosum, erythema nodosum, uveitis - 1 per manifestation).|3 months|ITT Population||Percentage of Participants|||Number
744121|NCT00506662|Secondary|Change in Mean Pre-dinner Plasma Glucose at Month 7||week 0, month 7|Due to the recruitment issue, the trial has been prematurely interrupted and the final number of patients does not allow any efficacy analysis.|||||
747606|NCT00530842|Secondary|Static Lung Volumes|Trough RV (Residual Volume) after 4 weeks (measured by bodyphlethysmography)|4 weeks|FAS using imputed values||Litres||Standard Error|Mean
744041|NCT00505778|Primary|Percentage of Patients Remaining in Remission at Month 6, ITT Population, Determined by the Simple Clinical Colitis Activity Index (SCCAI)|Remission defined as SCCAI <5. Simple Clinical Colitis Activity Index: minimum score 0, maximum score 19, reflects disease activity over the 24 hours prior to completion. Composite Score: bowel frequency (day, 0-3) (night, 0-2), defecation urgency (0-3), blood in stool (0-3), general well being (0-4), extracolonic features (arthritis, pyoderma gangrenosum, erythema nodosum, uveitis - 1 per manifestation).|6 months|ITT Population||Percentage of Participants|||Number
744042|NCT00505895|Secondary|Acute Grade II-IV Graft Versus Host Disease (GVHD)|Effects of Rituximab as measured by percentage of participants with Acute and Chronic Graft Versus Host Disease (GVHD) incidences after allogeneic transplantation. GVHD occurring anytime after day 90 post transplant was considered chronic GVHD; otherwise it was considered acute GVHD. Acute GVHD status defined as GVHD with maximum grade ≥2. Clinical grading of Acute GVHD (Thomas et al., New England Journal of Medicine (NEJM), 229:895, 1975): Grade 1 to 4.|GVHD grading weekly during first 100 days; Annual examinations for nine year study period|For the acute GVHD analysis, only 48 patients’ data were available.||percentage of participants|||Number
744043|NCT00505895|Primary|Number of Participants With Successful Engraftment at Day 100||Day 100|||participants|||Number
744044|NCT00505921|Primary|Participant Progression Free Survival at 2 Years|Progression-free survival defined as the number of participants without evidence of progression or death after 2 years from stem cell transplant.|2 years|Analysis was per protocol. Nine participants were not eligible for treatment therefore were excluded from analysis.||participants|||Number
744045|NCT00505934|Secondary|Number of Consecutive Levetiracetam Intravenous (LEV IV) Doses Received||Treatment period (up to 4 days)|All 19 subjects enrolled in the study were included in the Intent to Treat (ITT) population and are included in this analysis.||Consecutive doses||Standard Deviation|Mean
744046|NCT00505934|Secondary|Number of Subjects Who Received High-dose Levetiracetam Intravenous (LEV IV) (More Than 28 mg/kg/Day for Subjects <6 Months; >40mg/kg/Day for Subjects ≥6 Months) During the Treatment Period (up to 4 Days)||Treatment period (up to 4 days)|All 19 subjects enrolled in the study were included in the Intent to Treat (ITT) population and are included in this analysis.||Subjects|||Number
744047|NCT00505934|Primary|Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (up to 4 Days)||Treatment period (up to 4 days)|All 19 subjects enrolled in the study were included in the Intent to Treat (ITT) population and are included in this analysis.||Subjects|||Number
744048|NCT00506025|Primary|Antimicrobial Activity of Urine From Pregnant Subjects Following Cranberry Juice Cocktail (CJC)|The primary outcome measure was the measurement of bacteriuria in study subject urine, defined as having a urine culture with 100,000 or more of a single uropathogen (measured as cfu per ml).|7 months, from enrollment at 3 months of pregnancy to delivery|a priori for a pilot study||cfu per ml||Full Range|Median
744049|NCT00506064|Primary|Objective Sleep Response of Patients|Objective responses measured by wrist actigraph (measures sleep movement), and the Sp02 monitor (measures the % oxy-hemoglobin in the blood)|Longitudinal study with major responses measured on days 0 (day of operation) and days 1-6 post-operative|Since unable to accrue an adequate number of cases with data, unable to provide analysis.|||||
744050|NCT00506077|Other Pre-specified|Pre-randomization Baseline: Working Memory Composite Score|"Pre-randomization baseline values for all treatment sequences are equal because
the constrained longitudinal data analysis (cLDA) model was used
(Liang and Zeger, 2000, Sankhya: The Indian Journal of Statistics, Series B 62, 134–148)."|Pre-randomization Baseline|Full Analysis Set (FAS): The FAS included all randomized patients who took at lease one dose of study medication and had at least one post-randomization efficacy measurement in either of the two treatment periods. The data as observed (DAO) approach was used to handle missing data.||Composite T-score||Standard Error|Least Squares Mean
744051|NCT00506077|Other Pre-specified|Pre-randomization Baseline: Episodic Memory Composite Score|"Pre-randomization baseline values for all treatment sequences are equal because
the constrained longitudinal data analysis (cLDA) model was used
(Liang and Zeger, 2000, Sankhya: The Indian Journal of Statistics, Series B 62, 134–148)."|Pre-randomization Baseline|Full Analysis Set (FAS): The FAS included all randomized patients who took at lease one dose of study medication and had at least one post-randomization efficacy measurement in either of the two treatment periods. The data as observed (DAO) approach was used to handle missing data.||Composite T-score||Standard Error|Least Squares Mean
744052|NCT00506077|Other Pre-specified|Pre-randomization Baseline: Attention/Processing Speed Composite Score|"Pre-randomization baseline values for all treatment sequences are equal because
the constrained longitudinal data analysis (cLDA) model was used
(Liang and Zeger, 2000, Sankhya: The Indian Journal of Statistics, Series B 62, 134–148)."|Pre-randomization Baseline|Full Analysis Set (FAS): The FAS included all randomized patients who took at lease one dose of study medication and had at least one post-randomization efficacy measurement in either of the two treatment periods. The data as observed (DAO) approach was used to handle missing data.||Composite T-score||Standard Error|Least Squares Mean
744053|NCT00506077|Other Pre-specified|Pre-randomization Baseline: Total Cognitive Score on the Brief Assessment of Cognition in Schizophrenia (BACS) Battery.|"Pre-randomization baseline values for all treatment sequences are equal because
the constrained longitudinal data analysis (cLDA) model was used
(Liang and Zeger, 2000, Sankhya: The Indian Journal of Statistics, Series B 62, 134–148)."|Pre-randomization Baseline|Full Analysis Set (FAS): The FAS included all randomized patients who took at lease one dose of study medication and had at least one post-randomization efficacy measurement in either of the two treatment periods. The data as observed (DAO) approach was used to handle missing data.||Composite T-score||Standard Error|Least Squares Mean
744054|NCT00506077|Secondary|Mean Change From Baseline at 4 Weeks of Treatment in Working Memory Composite Score|The Working Memory Composite Score was comprised of the University of Pennsylvania’s Computerized Neuropsychological (CNP) battery N-back test and the BACS battery Digit Sequencing test. The composite score was calculated as a weighted average of the T-scores (normalized for age) for each test. The minimum and maximum values possible for this composite T-score of the change from baseline were -122 and 122, respectively. Higher values (positive changes from baseline) indicate better performance.|Baseline and 4 weeks of treatment|Full Analysis Set (FAS): The FAS included all randomized patients who took at lease one dose of study medication and had at least one post-randomization efficacy measurement in either of the two treatment periods. The data as observed (DAO) approach was used to handle missing data.||Composite T-score||95% Confidence Interval|Least Squares Mean
744055|NCT00506077|Secondary|Mean Change From Baseline at 4 Weeks of Treatment in Episodic Memory Composite Score|The Episodic Memory Composite Score was comprised of the University of Pennsylvania’s Computerized Neuropsychological Battery (CNP) Face Memory and BACS battery Verbal Memory. The composite score was calculated as a weighted average of the T-scores (normalized for age) for each test. The minimum and maximum values possible for this composite T-score of the change from baseline were -202 and 202, respectively. Higher values (positive changes from baseline) indicate better performance.|Baseline and 4 weeks of treatment|Full Analysis Set (FAS): The FAS included all randomized patients who took at lease one dose of study medication and had at least one post-randomization efficacy measurement in either of the two treatment periods. The data as observed (DAO) approach was used to handle missing data.||Composite T-score||95% Confidence Interval|Least Squares Mean
744056|NCT00506077|Secondary|Mean Change From Baseline at 4 Weeks of Treatment in Attention/Processing Speed Composite Score|The Attention/Processing Speed Composite Score was comprised of the University of Pennsylvania's Computerized Neuropsychological Battery (CNP) Penn Continuous Performance Test (PCPT) and BACS battery Symbol Coding. The composite score was calculated as a weighted average of the T-scores (normalized for age) for each test. The minimum and maximum values possible for this composite T-score of the change from baseline were -91 and 91, respectively. Higher values (positive changes from baseline) indicate better performance.|Baseline and 4 weeks of treatment|Full Analysis Set (FAS): The FAS included all randomized patients who took at lease one dose of study medication and had at least one post-randomization efficacy measurement in either of the two treatment periods. The data as observed (DAO) approach was used to handle missing data.||Composite T-score||95% Confidence Interval|Least Squares Mean
744057|NCT00506077|Primary|Mean Change From Baseline at 4 Weeks of Treatment in Total Cognitive Score on the Brief Assessment of Cognition in Schizophrenia (BACS) Battery.|The mean change from baseline after 4 weeks of treatment in total cognitive score on the BACS was calculated as a weighted average of T-scores (normalized for age) from BACS subtests including Verbal Memory, Digit Sequencing, Token Motor, Symbol Coding, Semantic Fluency, Letter Fluency, and Tower of London. The minimum and maximum values possible for this composite T-score of the change from baseline were -131 and 131, respectively. Higher values (positive changes from baseline) indicate better performance.|Baseline and 4 weeks of treatment|Full Analysis Set (FAS): The FAS included all randomized patients who took at lease one dose of study medication and had at least one post-randomization efficacy measurement in either of the two treatment periods. The data as observed (DAO) approach was used to handle missing data.||Composite T-score||95% Confidence Interval|Least Squares Mean
744058|NCT00506155|Secondary|5-year Overall Survival (OS)|The overall survival rate stated as a five-year survival rate, which is the percentage of participants in study who are alive five years after the start of treatment.|5 years|||Percentage of Participants|||Number
744059|NCT00506155|Primary|Percentage of Participants With Response Defined as the Absence of Residual Muscle Invasive Cancer in Resected Specimen|"Number of participants out of total with a response defined as “downstaging” to <= pT1N0 in the resected specimen. A binary variable was defined for downstaging (pathologic stage below initial clinical stage and below pT1N1N0M0); staging using American Joint Committee on Cancer (AJCC) TNM system of TNM; T describes size tumor & cancer spread into nearby tissue; N describes spread to nearby lymph nodes; & M describes metastasis (spread to other parts of body). Numbers after T (such as T1, T2, T3, and T4) describe tumor size and/or amount of spread into nearby structures, higher the T number, the larger the tumor and/or more it has grown into nearby tissues. Responses of lesser magnitude scored as treatment failure. Response Evaluation Criteria In Solid Tumors (RECIST) criteria do not apply for this cohort of neoadjuvant participants since this study does not require measurable disease by traditional assessment."|Following 20 weeks of chemotherapy|All 60 participants completed at least 1 cycle of chemotherapy.||Percentage of Participants|||Number
744060|NCT00506285|Secondary|Conners' Adult ADHD Rating Scales (CAARS)|Measures the DSM based ADHD criteria of Inattention and Hyperactivity/Impulsivity. There are 30 items scored 0-3 for a minimum score of 0 (no symptoms) and a maximum score of 90 worst possible symptoms.|Double-blind endpoints for MTS and placebo arms|||units on a scale||Standard Deviation|Mean
744061|NCT00506285|Primary|Wender Reimherr Adult Attention Deficit Disorder Scale|This scale measures the 7 domains of the Utah Criteria for Adult ADHD. Total scores run from 0 to 28. Normative samples average below 5. The worst possible score is 28.|Double-blind endpoints during MTS and placebo arms|"All subjects given active treatment last observation carried forward using a mixed models design."||units on a scale||Standard Deviation|Mean
744062|NCT00506350|Secondary|Frequency of Antigen-specific CD4/CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines|Among cytokines expressed after background reduction were cluster of differentiation 4 all doubles (CD4 all doubles), cluster of differentiation 40-ligand (CD40-L), interleukin-2 (IL-2), interferon-gamma (IFN-γ) and tumour necrosis factor-alpha (TNF-α). The flu strains assessed were H5N1 A/Indonesia and H5N1 A/Vietnam.|At Months 6, 12, 18 and 24|The analysis was performed on the ATP cohort for persistence, which consisted of all subjects who had serologic results available at the antibody persistence time point.||T-cell/million cells||Inter-Quartile Range|Median
744063|NCT00506350|Secondary|Frequency of Antigen-specific CD4/CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines|Among cytokines expressed after background reduction were cluster of differentiation 4 all doubles (CD4 all doubles), cluster of differentiation 40-ligand (CD40-L), interleukin-2 (IL-2), interferon-gamma (IFN-γ) and tumour necrosis factor-alpha (TNF-α). The flu strains assessed wwere H5N1 A/Indonesia and H5N1 A/Vietnam.|At Days 0 and 21|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.||T-cells/million cells||Inter-Quartile Range|Median
744064|NCT00506350|Secondary|Number of Seroprotected (SPR) Subjects for HI Antibodies Against the A/Indonesia/05/2005 Strain|Seroprotection rate was defined as the percentage of vaccines with a serum HI antibody titer ≥ 1:40 that usually is accepted as indicating protection. The flu strain assessed was A/Indonesia/05/2005 (H5N1).|At Months 6, 12, 18 and 24|The analysis was performed on the ATP cohort for persistence, which consisted of all subjects who had serologic results available at the antibody persistence time point.||Participants|||Count of Participants
744122|NCT00506662|Secondary|Change in Mean Pre-lunch Plasma Glucose at Month 4||week 0, month 4|Due to the recruitment issue, the trial has been prematurely interrupted and the final number of patients does not allow any efficacy analysis.|||||
744065|NCT00506350|Secondary|Number of Seroprotected (SPR) Subjects for HI Antibodies Against the A/Indonesia/05/2005 Strain|"Seroprotection rate was defined as the percentage of vaccines with a serum HI antibody titer ≥ 1:40 that usually is accepted as indicating protection.
The flu strain assessed was A/Indonesia/05/2005 (H5N1)."|At Days 0, 7, 14, 21, 28, 35 and 42|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.||Participants|||Count of Participants
744066|NCT00506350|Secondary|Seroconversion Factor (SCF) for H5N1 Haemagglutinin-inhibition (HI) Antibodies Against the A/Indonesia/05/2005 Strain|Seroconversion factor (SCF) was defined as the fold increase in H5N1 HI antibody GMTs post-vaccination compared to Day 0. The flu strains assessed were A/Indonesia/05/2005.|At Months 6, 12, 18 and 24|The analysis was performed on the ATP cohort for persistence, which consisted of all subjects who had serologic results available at the antibody persistence time point.||Fold increase||95% Confidence Interval|Geometric Mean
744067|NCT00506350|Secondary|Seroconversion Factor (SCF) for H5N1 Haemagglutinin-inhibition (HI) Antibodies Against the A/Indonesia/05/2005 Strain|Seroconversion factor (SCF) was defined as the fold increase in H5N1 HI antibody GMTs post-vaccination compared to Day 0. The flu strain assessed was A/Indonesia/05/2005.|At Days 7, 14, 21, 35 and 42|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.||Fold increase||95% Confidence Interval|Geometric Mean
744068|NCT00506350|Secondary|Number of Seroconverted (SCR) Subjects for Neutralizing HI Antibodies Against the A/Indonesia/05/2005 Strain|Seroconversion rate for neutralizing antibody response was defined as the percentage of vaccines who have either a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:56 or a pre-vaccination titer ≥ 1:56 and at least a 4-fold increase in post-vaccination titer.|At Months 6, 12, 18 and 24|The analysis was performed on the ATP cohort for persistence, which consisted of all subjects who had serologic results available at the antibody persistence time point.||Participants|||Count of Participants
744069|NCT00506350|Secondary|Number of Seroconverted (SCR) Subjects for Neutralizing HI Antibodies Against the A/Indonesia/05/2005 Strain|Seroconversion rate for anti-HA antibody response was defined as the percentage of vaccines who have either a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:56 or a pre-vaccination titer ≥ 1:56 and at least a 4-fold increase in post-vaccination titer.|At Days 21 (post-vaccination one) and 42 (post-vaccination two)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.||Participants|||Count of Participants
744070|NCT00506350|Secondary|Number of Seroconverted (SCR) Subjects for HI Antibodies Against the A/Indonesia/05/2005 Strain|SCR was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titer< 10 and a post-vaccination reciprocal titer ≥ 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post-vaccination reciprocal titer against the vaccine virus. The flu strain assessed was Flu A/Indonesia/05/2005.|At Months 6, 12, 18 and 24|The analysis was performed on the ATP cohort for persistence, which consisted of all subjects who had serologic results available at the antibody persistence time point.||Participants|||Count of Participants
744071|NCT00506350|Secondary|Number of Seroconverted (SCR) Subjects for HI Antibodies Against the A/Indonesia/05/2005 Strain|Seroconversion (SCR) was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer ≥ 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post-vaccination reciprocal titer against the vaccine virus. The flu strain assessed was Flu A/Indonesia/05/2005.|At Days 7,14, 21, 35 and 42|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.||Participants|||Count of Participants
744072|NCT00506350|Secondary|Titers for Serum H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain|Titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was A/Indonesia/05/2005.|At Months 6, 12, 18 and 24|The analysis was performed on the ATP cohort for persistence, which consisted of all subjects who had serologic results available at the antibody persistence time point.||Titers||95% Confidence Interval|Geometric Mean
744073|NCT00506350|Secondary|Titers for Serum H5N1 Haemaglutinin-inhibition (HI) Antibodies Against the A/Indonesia/05/2005 Strain|Titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was A/Indonesia/05/2005.|At Days 0, 7, 14, 21, 28, 35 and 42|The analysis was performed on the ATP cohort for immunogenicity, whiich included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.||Titers||95% Confidence Interval|Geometric Mean
744074|NCT00506350|Secondary|Titers for Serum Neutralizing HI Antibodies Against A/Indonesia/05/2005 Stain|Titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:28. The flu strain assessed was A/Indonesia/05/2005.|At Months 6, 12, 18 and 24|The analysis was performed on the ATP cohort for persistence, which included all subjects who had serologic results available at the antibody persistence time-point.||Titers||95% Confidence Interval|Geometric Mean
744075|NCT00506350|Secondary|Titers for Serum Neutralizing HI Antibodies Against A/Indonesia/05/2005 Strain|Titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:28. The flu strain assessed was A/Indonesia/05/2005. No subject from GSK1562902A AD F1 Primed Group has received a second vaccination.|At Days 0, 21 (post-vaccination one) and 42 (post-vaccination two)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.||Titers||95% Confidence Interval|Geometric Mean
744123|NCT00506662|Secondary|Change in Mean Pre-lunch Plasma Glucose at Month 7||week 0, month 7|Due to the recruitment issue, the trial has been prematurely interrupted and the final number of patients does not allow any efficacy analysis.|||||
773196|NCT00736125|Primary|The Number of Cerebral Emboli During Surgery as Measured by Transcranial Doppler (TCD)||During surgery|||emboli|||Number
744077|NCT00506350|Primary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 30-day (Days 0-29) follow-up period after the first vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Participants|||Count of Participants
744078|NCT00506350|Primary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 21-day (Days 0-20) follow-up period after the first vaccination and 30-day (Days 0-29) follow-up period after the second vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Participants|||Count of Participants
744079|NCT00506350|Primary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, headache, myalgia, shivering, sweating and fever [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as causally related to the study vaccination. No subject from GSK1562902A AD F1 Primed Group has received Dose 2.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had their symptom sheets filled in.||Participants|||Count of Participants
744080|NCT00506350|Primary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 ecchymosis/induration/redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. No subject from GSK1562902A AD F1 Primed Group has received Dose 2.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had their symptom sheets filled in.||Participants|||Count of Participants
744081|NCT00506350|Primary|Number of Seroprotected Subjects for H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain|A seroprotected subject was defined as a vaccinated subject with a serum HI titer equal to or above (≥) 1:40. The flu strain assessed was A/Indonesia/05/2005.|At Day 21|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.||Participants|||Count of Participants
744082|NCT00506350|Primary|Number of Seroprotected Subjects for H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain|A seroprotected subject was defined as a vaccinated subject with a serum HI titer equal to or above (≥) 1:40. The flu strain assessed was A/Indonesia/05/2005.|At Day 0|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.||Participants|||Count of Participants
744083|NCT00506350|Primary|Seroconversion Factor (SCF) for H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain|Seroconversion factor (SCF) was defined as the fold increase in H5N1 HI antibody GMTs post-vaccination compared to Day 0. The flu strain assessed was A/Indonesia/05/2005.|At Day 21|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.||Fold increase||95% Confidence Interval|Geometric Mean
744084|NCT00506350|Primary|Number of Seroconverted Subjects for H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain|Seroconversion rate for HI antibody response was defined as the percentage of vaccines who have either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.|At Day 21|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.||Participants|||Count of Participants
744085|NCT00506350|Primary|Titers for Serum H5N1 Haemagglutinin Inhibition (HI) Antibodies Against the A/Indonesia/05/2005 Strain|Titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was A/Indonesia/05/2005.|At Day 21|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.||Titers||95% Confidence Interval|Geometric Mean
744086|NCT00506350|Primary|Titers for Serum H5N1 Haemagglutinin Inhibition (HI) Antibodies Against the A/Indonesia/05/2005 Strain|Titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was A/Indonesia/05/2005.|At Day 0|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.||Titers||95% Confidence Interval|Geometric Mean
744124|NCT00506662|Secondary|Change in Mean Fasting Plasma Glucose (FPG) at Month 4||week 0, month 4|Due to the recruitment issue, the trial has been prematurely interrupted and the final number of patients does not allow any efficacy analysis.|||||
744087|NCT00506389|Secondary|Average Subjective Total Sleep Time (TST) During the In-Treatment Period|TST was defined as the total amount of time in minutes that was actually spent sleeping the previous night as recorded daily in the participant's sleep diary. TST values over the 6 week In-Treatment Period were averaged for each participant, and average TST was then reported by treatment arm. For participants with missing data, the average of the nights for which TST data were available was used in the analysis.|From Day 1 to Day 36|The ITT group consisted of all participants who were randomized, received at least one dose of double-blind trial medication, and had at least one post-randomization efficacy assessment. Fifteen participants from 1 site were excluded from all efficacy analyses.||Minutes||Standard Deviation|Mean
744088|NCT00506389|Secondary|Average Latency to Persistent Sleep (LPS) During the In-Treatment Period|LPS was defined as the time in minutes from lights out to the first 20 consecutive epochs scored as sleep as measured by PSG. LPS was calculated as the mean of Nights 1, 15, and 36.|From Day 1 to Day 36|The ITT group consisted of all participants who were randomized, received at least one dose of double-blind trial medication, and had at least one post-randomization efficacy assessment. Fifteen participants from 1 site were excluded from all efficacy analyses.||Minutes||Standard Deviation|Mean
744089|NCT00506389|Primary|Average Wake Time After Sleep Onset (WASO) During the In-Treatment Period|WASO was defined as the total objective time awake after the onset of persistent sleep until the end of the 8-hour sleep cycle period as measured by polysomnography (PSG). WASO was calculated as the mean of Nights 1, 15, and 36.|From Day 1 to Day 36|The Intent-to-Treat (ITT) group consisted of all participants who were randomized, received at least one dose of double-blind trial medication, and had at least one post-randomization efficacy assessment. Fifteen participants from 1 site were excluded from all efficacy analyses.||Minutes||Standard Deviation|Mean
744090|NCT00506415|Secondary|Number of Patients With Adverse Events, Serious Adverse Events and Discontinuations Due to Adverse Events||30 days after a maximum of 96 weeks treatment|The safety set included all patients who received at least one dose of study medication and who had at least one post-baseline safety assessment.||Participants|||Number
744091|NCT00506415|Secondary|Change From Baseline in Neuropsychiatric Inventory (NPI)-10 Score at Week 48 of Double Blind Period|Change from baseline to week 48 as assessed by the Neuropsychiatric Inventory (NPI)-10 total score. The scale consists of 10 domains that are rated for both frequency (range 1-4) and severity (range 1-3). A composite score for each domain is calculated (frequency x severity) which ranges from 1 to 12. There is a leading question for each item. If the symptom is not present then the frequency, severity and distress scores are not completed. In this case the score is 0 for the item. The sum of the composite scores yields the NPI-10 total score (range 0-120). A negative change in score indicates an improvement from baseline (symptom reduction).|Baseline and week 48 of double blind period|Intent to treat population double blind (ITT-DB): included all randomized patients with an assessment at baseline and week 48, who received at least 1 dose of double blind study drug, and had at least 1 post-randomization assessment for both co-primary efficacy variables (ADAS-cog, ADCS-IADL).||units on a scale||Standard Deviation|Mean
744092|NCT00506415|Secondary|Change in Attention and Executive Function as Assessed by the Trail Making Test (Part B) at Week 48 of Double Blind Period|Change from baseline to week 48 in total time to perform Trail Making Test (TMT) part B. This test provides information on visual search, scanning, speed of processing, mental flexibility, and executive functions. TMT has two parts: Part A requires an individual to draw lines sequentially connecting 25 encircled numbers distributed on a sheet of paper. Task requirements are similar for TMT-Part B except the person must alternate between numbers and letters. Total values for TMT part B range between 0 and 420 seconds. A negative change from baseline indicates an improvement in condition.|Baseline and week 48 of double blind period|Intent to treat population (ITT-DB): included all randomized patients with an assessment at baseline and week 48 who received at least 1 dose of double blind study drug, and had at least 1 post-randomization assessment for both co-primary efficacy variables (ADAS-cog, ADCS-IADL).||Time in seconds||Standard Deviation|Mean
744093|NCT00506415|Secondary|Change in Attention and Executive Function as Assessed by the Trail Making Test (Part A) at Week 48 of the Double Blind Period|Change from baseline to week 48 in total time to perform Trail Making Test (TMT) part A. This test provides information on visual search, scanning, speed of processing, mental flexibility, and executive functions. The TMT part A requires an individual to draw lines sequentially connecting 25 encircled numbers distributed on a sheet of paper. The score represents the amount of time required to complete the task. Total values for TMT part A range between 0 and 300 seconds. A negative change indicates an improvement from baseline.|Baseline and week 48 of double blind period|Intent to treat population (ITT-DB): included all randomized patients with an assessment at baseline and week 48 who received at least 1 dose of double blind study drug, and had at least 1 post-randomization assessment for both co-primary efficacy variables (ADAS-cog and ADCS-IADL).||Time in seconds||Standard Deviation|Mean
744094|NCT00506415|Secondary|Time to Functional Decline as Measured by Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living (ADCS-IADL) Subscale During the Double Blind Period|Functional decline was defined by either an at least 1 point decrease in the Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living (ADCS-IADL) subscale score in a visit and confirmed by the following visit/assessment or at least 2 points decrease from the double blind randomization baseline.|390 days was the maximum|Intent to treat population double blind (ITT-DB): included all randomized patients who received at least 1 dose of double blind study drug, and had at least 1 post-randomization assessment for both co-primary efficacy variables: Alzheimer's Disease Assessment Scale-Cognitive and Disease Cooperative Study-Instrumental Activities of Daily Living.||Time in days||95% Confidence Interval|Median
744095|NCT00506415|Primary|Change in Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living (ADCS-IADL) Subscale Score From Baseline to Week 48 of Double Blind Period|The Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living (ADCS-IADL) is a 16 item subscale of the caregiver-based ADCS-IADL scale, developed for the use in dementia studies. The ADCS-IADL total score ranges from 0 to 56, with higher scores indicating less severe impairment. A positive change indicates an improvement from baseline.|Baseline and week 48 of double blind period|Intent to treat population double blind (ITT-DB): included all randomized patients who received at least 1 dose of double blind study drug, and had at least 1 post-randomization assessment for both co-primary efficacy variables: Alzheimer's Disease Assessment Scale-Cognitive and Disease Cooperative Study-Instrumental Activities of Daily Living.||units on a scale||Standard Deviation|Mean
744096|NCT00506415|Primary|Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) Subscale at Week 48 of Double Blind Period|The Alzheimer's Disease Assessment Scale-Cognitive (ADAS-cog) subscale comprises 11 items summed to a total score ranging from 0 to 70, with lower scores indicating less severe impairment. A negative change indicates an improvement from baseline.|Baseline and week 48 of double blind period|Intent to treat population double blind (ITT-DB): included all randomized patients who received at least 1 dose of double blind study drug, and had at least 1 post-randomization assessment for both co-primary efficacy variables: Alzheimer's Disease Assessment Scale-Cognitive and Disease Cooperative Study-Instrumental Activities of Daily Living.||units on a scale||Standard Deviation|Mean
744097|NCT00506441|Secondary|Incidence of Adverse Events||12 weeks (Week 0-12) and 4 weeks (Week 12-16)||||||
744098|NCT00506441|Secondary|Change From Baseline in Triglyceride||12 weeks||||||
744099|NCT00506441|Secondary|Change From Baseline in VLDL Cholesterol||12 weeks||||||
744100|NCT00506441|Secondary|Change From Baseline in HDL Cholesterol||12 weeks||||||
744101|NCT00506441|Secondary|Change From Baseline in LDL Cholesterol||12 weeks||||||
744102|NCT00506441|Secondary|Change From Baseline in Total Cholesterol||12 weeks||||||
744103|NCT00506441|Secondary|Change From Baseline in Calcium x Phosphorus Ion Product||12 weeks||||||
744104|NCT00506441|Secondary|Change From Baseline in Calcium||12 weeks||||||
744105|NCT00506441|Secondary|Change From Baseline in PTH||12 weeks||||||
744106|NCT00506441|Secondary|Change From Baseline in Serum Phosphorus||12 weeks (Week 0 to Week 12)|ITT1 (The ITT1 population included all enrolled subjects who have taken at least one dose of study medication and have at least one central phosphorus value after the start of study medication.)||mg/dL||95% Confidence Interval|Mean
744107|NCT00506441|Primary|The Change in Serum Phosphorus From Week 12 to Week 16|The changes in serum phosphorus (mg/dL) from Week 12 to Week 16 (last observation post Week 12)|4 weeks (Week 12 to Week 16)|Intent-to-treat (ITT) 2 (The ITT2 population included all subjects who complete 12-weeks, receive a randomization number and receive at least one dose of study medication in the placebo-controlled withdrawal phase, either MCI-196 or placebo, and have at least one central phosphorus value after 12-weeks.)||mg / dL||Standard Deviation|Mean
744108|NCT00506454|Primary|Reduction in Endotoxin Levels.|The number of participants whose post-hemodialysis endotoxin (as measured by Endotoxin Activity Assay (EAA)) was less than their pre-hemodialysis endotoxin.|Baseline and at 4 weeks|||Participants|||Number
744109|NCT00506493|Secondary|Safety Endpoints: Composite 9-month Major Adverse Event Rate, Post-procedure|Major Adverse Events were defined to include: mediastinitis, death, myocardial infarction, stroke, transient ischemic attacks (TIA), pulmonary embolism, peripheral arterial embolism, and esophageal injury.|9 months|||percentage of subjects|||Number
744110|NCT00506493|Secondary|Efficacy Endpoints: The Percent of Patients Out of AF, Regardless of Antiarrhythmic Drug Status, as Determined by a 24 Hour Holter Recording at 9 Months||9 months|||percentage of subjects|||Number
744111|NCT00506493|Primary|Safety Endpoint: Composite Acute Major Adverse Event Rate, Within 30 Days Post-procedure or Hospital Discharge|Major Adverse Events were defined to include: mediastinitis, death, myocardial infarction, stroke, transient ischemic attacks (TIA), pulmonary embolism, peripheral arterial embolism, and esophageal injury.|30 days post procedure or hospital discharge|||percentage of subjects|||Number
744112|NCT00506493|Primary|Efficacy Endpoint: The Percent of Patients Off Class I or III Antiarrhythmic Drugs and Out of AF as Determined by 24 Hour Holter Recording at 9 Months|Subject's cardiac rhythm was assessed by wearing a Holter Monitor for 24 hours|9 months|75 subjects were enrolled, 14 subjects had no Holter assessment performed- 6 subjects died, 5 subjects withdrew participation, and 3 subjects completed endpoint follow-up without analyzable Holter data.||percentage of subjects|||Number
744113|NCT00506597|Primary|Number of Participants Treated With Erwinase as a Replacement for E.Coli L-asparaginase or Pegylated E.Coli L-asparaginase as Part of the Treatment for Acute Lymphoblastic Leukemia (ALL) or T or B Cell Lymphoma|Main objective of protocol Erwinase® Master Treatment Protocol (EMTP) was to enable United States (US) participants who were treated for Acute Lymphoblastic Leukemia (ALL) and who were allergic to Escherichia coli derived L-Asparaginase, whatever the formulation, to be treated with Erwinia derived L-Asparaginase (Erwinase®), under Investigational New Drug (IND) 290.|4 years|||participants|||Number
744114|NCT00506597|Primary|Participant Toxicity Data|Toxicity data collected and reported as adverse events during the study period. See Adverse Event section for reporting.|3 Years||||||
744115|NCT00506662|Secondary|Mean Number of Total Hypoglycaemic Episodes, Months 5-7|Mean number of total hypoglycaemic episodes per patient expressed as rate per week by visit. Rate per week is calculated by dividing the number of episodes for each patient by the number of weeks in the period.|weeks -2-0, months 5-7|The safety analysis set is all patients who had been exposed to at least one dose of the trial product, and had hypoglycaemia data available at both endpoints.||episodes per week by visit||Standard Deviation|Mean
744116|NCT00506662|Secondary|Mean Number of Total Hypoglycaemic Episodes, Months 2-4|Mean number of total hypoglycaemic episodes per patient expressed as rate per week by visit. Rate per week is calculated by dividing the number of episodes for each patient by the number of weeks in the period.|weeks -2-0, months 2-4|The safety analysis set is all patients who had been exposed to at least one dose of the trial product, and had hypoglycaemia data available at both endpoints.||episodes per week by visit||Standard Deviation|Mean
744117|NCT00506662|Secondary|Mean Number of Total Hypoglycaemic Episodes, Month 1|Mean number of total hypoglycaemic episodes per patient expressed as rate per week by visit. Rate per week is calculated by dividing the number of episodes for each patient by the number of weeks in the period.|weeks -2-0, month 1|The safety analysis set is all patients who had been exposed to at least one dose of the trial product, and had hypoglycaemia data available at both endpoints.||episodes per week by visit||Standard Deviation|Mean
744118|NCT00506662|Secondary|Change in Body Weight at Month 4||week 0, month 4|Due to the recruitment issue, the trial has been prematurely interrupted and the final number of patients does not allow any efficacy analysis.|||||
744119|NCT00506662|Secondary|Change in Body Weight at Month 7||week 0, month 7|Due to the recruitment issue, the trial has been prematurely interrupted and the final number of patients does not allow any efficacy analysis.|||||
747607|NCT00530842|Secondary|Static Lung Volumes|Trough RV (Residual Volume) after 8 weeks (measured by bodyphlethysmography)|8 weeks|FAS using imputed values||Litres||Standard Error|Mean
744128|NCT00506675|Primary|Mean (SD) Change in Visual Acuity in the Amblyopic Eye at the 10 Week Primary Outcome Exam|Change in logMAR from baseline to 10 weeks was calculated, with positive difference indicating improvement. Note one logMAR line = 5 letters or one Snellen line equivalent.|baseline to 10 Weeks|||logMAR||Standard Deviation|Mean
744129|NCT00506675|Primary|Distribution of Amblyopic Eye Visual Acuity Change From Baseline to 10 Weeks|Change in logMAR from baseline to 10 weeks was calculated, with positive difference indicating improvement. Note one logMAR line = 5 letters or one Snellen line equivalent.|baseline to 10 Weeks|||Participants|||Number
744130|NCT00506675|Primary|Mean (SD) Distribution of Visual Acuity at 10 Weeks|Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol resulting in a Snellen acuity score that can range from 20/16 to 20/800 for ages 3 to <7; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. Scores were converted to log of minimum angle of resolution (logMAR) equivalents for analyses (lower logMAR value is better than higher logMAR).|10 Weeks|||logMAR||Standard Deviation|Mean
744131|NCT00506675|Primary|Distribution of Amblyopic Eye Visual Acuity at 10 Weeks|Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol resulting in a Snellen acuity score that can range from 20/16 to 20/800 for ages 3 to <7; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. Scores were converted to log of minimum angle of resolution (logMAR) equivalents for analyses (lower logMAR value is better than higher logMAR).|10 Weeks|||participants|||Number
744132|NCT00506714|Secondary|Gait Velocity|Gait velocity when adults with symptomatic hip osteoarthritis walked with a cane after four weeks of cane use|4 weeks|Analysis was per protocol||cm/s||Standard Deviation|Mean
744133|NCT00506714|Secondary|Gait Velocity With a Cane in Hip OA Subjects|Measured gait velocity when hip OA subjects walked with a cane at the baseline visit.|Baseline|Analysis was per protocol||cm/s||Standard Deviation|Mean
744134|NCT00506714|Primary|Gait Velocity||Baseline|Analysis was per protocol||cm/s||Standard Deviation|Mean
744135|NCT00498927|Secondary|Overall Survival|All patients will have their tumor measurements recorded at baseline and at the time of each MRI scan. Lesions must be measured in two dimensions. The dose of gadolinium must be held constant from scan to scan. Macdonald criteria will be used for assessment of tumor response.|2 years|Glioblastoma patients||months||95% Confidence Interval|Median
744136|NCT00498927|Primary|Progression-free Survival (PFS) Rate at 6 Months|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|at 6 months|Glioblastoma patients||percentage of participants|||Number
744137|NCT00498940|Secondary|Secondary End Points Include Incidence of Arrhythmias, Inotropic Support, Urine Output, Weight Gain, Morbidity, Mortality, and ICU Costs.||30 days after surgery||||||
744138|NCT00498940|Primary|Thermal Dilution Cardiac Index (CI) Measured in the Intensive Care Unit (ICU).|Cardiac output (CO) 12-24 hours after bypass is measured five times and averaged. CO is then converted to CI, after division by the patient's body surface area.|24 hours|||L/min/m^2||Standard Error|Mean
744139|NCT00499031|Secondary|Duration of Overall Survival||From study entry to death or the date of last contact, up to 5 years||||||
744140|NCT00499031|Secondary|Frequency and Severity of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0||Up to 5 years||||||
744141|NCT00499031|Secondary|Duration of Objective Response Rate||Up to 5 years||||||
744142|NCT00499031|Secondary|Duration of Progression-free Survival||From study entry until disease progression, death or date of last contact, up to 5 years||||||
744143|NCT00499031|Primary|Objective Tumor Response Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)|"Response is measured according to Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.0):
Complete Response (CR) is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart.
Partial Response (PR) is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD.
Disease Progression is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.
Stable Disease is any condition not meeting the above criteria.
Indeterminate is defined as having no repeat tumor assessments following initiation of study therapy for reasons unrelated to symptoms or signs of disease."|every other cycle for the first 6 months; then every 3 months x 2; then every 6 months|Total number of eligible and evaluable participants||participants|||Number
744144|NCT00499031|Primary|Progression-free Survival Greater Than 6 Months||At 6 months|Total number of eligible and evaluable participants||participants|||Number
744145|NCT00499096|Secondary|Body Mass Index (BMI)|Body mass index (BMI) is reported in kilograms divided by meters squared (kg/m^2) with a normal (healthy) range of 18-24, in which >=25 is considered overweight, and >=30 is the definition of obesity|24 months|||kg/m^2||Standard Deviation|Mean
744146|NCT00499096|Secondary|Disability Based on WHO-DAS Score|Disability based on the WHO Disability Assessment Scale (WHO-DAS); range = 0-24, higher score equals greater disability|24 months|||units on a scale||Standard Deviation|Mean
744147|NCT00499096|Secondary|Depressive Symptom Score|Depressive symptoms based on the Internal State Scale (Range: 0-200, higher score = more severe symptoms)|24 months|||units on a scale||Standard Deviation|Mean
744148|NCT00499096|Primary|Physical Health-related Quality of Life Score|Physical health-related quality of life is based on the Short Form (SF)-12 survey physical health component (PCS) score- which ranges from 0 to 50, with higher scores indicating higher quality of life|24 months|||units on a scale||Standard Deviation|Mean
744149|NCT00499096|Primary|Total Cholesterol|Total cholesterol in mg/dl- lower is better|24 months|||mg/dL||Standard Deviation|Mean
744150|NCT00499096|Secondary|Manic Symptoms|Manic symptoms based on the Internal State Scale (range is 0-500; higher score indicates more severe symptoms)|24 months|||units on a scale||Standard Deviation|Mean
744151|NCT00499096|Primary|Systolic and Diastolic Blood Pressure (SBP, DBP)|24-month systolic and diastolic blood pressure (mm/Hg): lower is better|24 months|||mm/Hg||Standard Deviation|Mean
744152|NCT00499109|Secondary|Response Rate (RR)|Number of participants per response category. Response to treatment was determined according to Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.|6 months|All evaluable participants||participants|||Number
744153|NCT00499109|Secondary|Overall Survival (OS)|OS at 12 months, determined from the date of randomization. The time interval from randomization to the date of death was calculated for each patient and used to generate Kaplan-Meier survival estimates and to calculate the overall survival.|12 months|All participants||estimated percentage of participants||95% Confidence Interval|Number
744154|NCT00499109|Primary|Progression Free Survival (PFS)|PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Progressive Disease (PD): Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. The data of first documented disease progression or death, as defined by Response Evaluation Criteria In Solid Tumors (RECIST), was recorded, and the time interval from randomization to that date was calculated for each patient and used to generate Kaplan-Meier survival estimates and to calculate the PFS at 6 months.|6 months|All participants||estimated percentage of participants||95% Confidence Interval|Number
744155|NCT00499122|Secondary|The Correlation of Serum Protein Glutathionylation With Clinical and Pathologic Responses||About 7 months||||||
744156|NCT00499122|Secondary|Definition of the Safety Profiles of Protocol Therapy|Definition of the safety profiles of protocol therapy in study participants as shown by the number of study participants experiencing adverse events or other toxicity.|Up to 30 days Post-Last Dose of Protocol Therapy, About 7 months|||participants|||Number
744157|NCT00499122|Primary|Percentage of Participants Achieving Pathologic Complete Response|Pathologic complete response (pCR) is defined according to Hankoop et al [41] as either: the absence of any histological evidence of invasive breast cancer cells in the tissue specimen removed from the breast or the presence of invasive tumor equal to or less than 10mm after preoperative treatment, determined at definitive breast surgery.|About 7 months|Study participants who had received at least one cycle of protocol therapy.||percentage of participants||95% Confidence Interval|Number
744158|NCT00506831|Secondary|Change in Serum Autoantibody Profile at 6 Months Compared to Baseline||6 months compared to baseline||||||
744159|NCT00506831|Secondary|Change in High Throughput Gene Expression Analysis at 6 Months Compared to Baseline||6 months compared to baseline||||||
744160|NCT00506831|Secondary|Change in Serum Cytokine Profile at 6 Months Compared to Baseline||6 months compared to baseline||||||
744161|NCT00506831|Secondary|Change in Dermal Thickness and Collagen Separation on Cutaneous Histopathology at 6 Months Compared to Baseline||6 months compared to baseline||||||
744162|NCT00506831|Secondary|Change in Scleroderma Health Assessment Questionnaire at 6 Months Compared to Baseline||6 months compared to baseline||||||
744163|NCT00506831|Secondary|Change in Digital Ulcerations at 6 Months Compared to Baseline||6 months compared to baseline||||||
744164|NCT00506831|Secondary|Change in Pulmonary Function Tests at 6 Months Compared to Baseline||6 months compared to baseline||||||
744165|NCT00506831|Primary|Percent Change in Modified Rodnan Skin Score at 6 Months Compared to Baseline|Modified Rodnan skin score (mRSS) on scale of 0 (no skin disease) to 51 severe skin disease. %change in mRSS=(score at 6 months - baseline score)/baseline score. Negative values indicate improvement in skin disease. Clinical important improvement defined as > 25% improvement.|6 months compared to baseline|||percentage of change in MRSS||Standard Deviation|Mean
744166|NCT00506857|Secondary|Number of Participants With Graft Versus Host Disease (GVHD)|Tacrolimus and Methotrexate used for acute graft versus host disease (aGVHD) prophylaxis, clinical grading AGVHD criteria (Days 1-100): Grade 1: + to ++ skin rash; no gut involvement; no decrease in clinical performance status; Grade 2: + to +++ skin rash; + gut involvement and/or + liver involvement; mild decrease in performance status; Grade 3: ++ to +++ skin rash; ++ to +++ gut involvement and/or ++ to ++++ liver involvement; marked decrease in performance status; Grade 4: Similar to Grade 3 with ++ to ++++ organ involvement and extreme decrease in performance status.|5 years|Analysis was per protocol for 73 patients out of 80 patients due to 3 early deaths and 4 non engraftments.||Participants|||Number
744167|NCT00506857|Primary|Maximum Tolerated Dose (MTD)|"Continual reassessment method (four times a day) used to determine an MTD, with a target toxicity probability of 20%, where toxicity is defined as grade 3 or 4 conventional toxicity [National Cancer Institute Common Toxicity Criteria (NCI-CTC)]. Participant evaluation in a cohort with each modality is 30 days."|1 month|Analysis was per protocol.||mg/kg|||Number
744168|NCT00506883|Primary|Responders|Responders were defined as patients who achieved a ≥ 50% reduction in target joint pain score from baseline at 24 hours without using rescue drug, using an 11 point scale from 0 to 10, with 10 being the worst pain imaginable after beginning therapy.|24 hours after baseline|The Intent-to-Treat (ITT) population(N=184) was used. The ITT group is defined as all patients who were randomized,and had a qualifying gout flare based on contact with the Gout Flare Call Center, who were instructed to begin taking and took at least one dose of the study drug study drug. One patient had a flare, but||Participants|||Number
744169|NCT00506922|Primary|Number of Patients Without GVHD at 100 Days|The primary efficacy endpoint of escalating doses Pentostatin with Tacrolimus + Methotrexate is success, defined to be that the patient is alive, engrafted, and without acute graft-versus-host disease (GVHD) at 100 days.|100 days|All analysis was intention to treat (ITT).||participants|||Number
744170|NCT00506948|Primary|Number of Participants With Acute Graft-versus-host Disease (aGVHD)|Participants who had acute graft-versus-host disease (aGVHD) within 100 days post transplant. Physical exam and bloodwork every week (for the first 90-100 days after the transplant).|Baseline to 100 days post transplant|||participants|||Number
744171|NCT00506948|Primary|Failure Rate|Efficacy failure defined as a participants who had either grade 3-4 acute graft-versus-host disease (aGVHD) or treatment related mortality (TRM) within 100 days post transplant. Failure Rate calculated as (# of failures) / (# participants evaluated). Physical exam and bloodwork every week (for the first 90-100 days after the transplant).|Baseline to 100 days post transplant||||||
747585|NCT00530842|Secondary|Static Lung Volumes (Percent)|Post-dose TGV/TLC (Thoracic Gas Volume over Total Lung Capacity) after 8 weeks (measured by bodyphlethysmography)|8 weeks|FAS using imputed values||Percent of TGV over TLC||Standard Error|Mean
744172|NCT00507416|Secondary|Change From Baseline in EORTC QLQ-C30 - Global Health Status|"The European Organisation for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).
The EORTC QLQ-C30 Global Health Status/QOL Scale is scored between 0 and 100, where higher scores indicate better Global Health Status/QOL. Negative changes from baseline indicate deterioration in QOL or functioning and positive changes indicate improvement."|Baseline and Day 1 of Cycles 3, 5, 7, 9, 11 and 13|"Intent-to-treat population with available data at each time point (indicated by n)."||units on a scale||Standard Deviation|Mean
744173|NCT00507416|Secondary|Time to Alternative Therapy|Time to alternative therapy is defined as the time between randomization and alternative therapy. Participants who did not receive alternative therapy were censored at the time of last contact.|From randomization until alternative therapy. Median follow-up time was 43 months.|Intent to Treat||months||95% Confidence Interval|Median
744174|NCT00507416|Secondary|Overall Survival|Overall survival is defined as the time between randomization and death. Participants still alive at the cutoff date or lost to follow-up were censored at the date of last contact.|From randomization until death. Median follow-up time was 43 months.|Intent to treat||months||95% Confidence Interval|Median
744175|NCT00507416|Secondary|Duration of Response|Duration of response is defined in participants with an overall response as the time between first documentation of response and disease progression. Responders without disease progression were censored at the last clinical assessment of response.|From first documented response until disease progression. Median follow-up time was 43 months.|Participants with an overall response||months||95% Confidence Interval|Median
744176|NCT00507416|Secondary|Percentage of Participants With a Complete Response or a Very Good Partial Response|"Complete response is defined by negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow.
Very good partial response is defined by serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100 mg per 24 hours.
Response was assessed by the Investigator using the IMWG uniform response criteria."|Response assessed every other cycle for up to 13 cycles (49 weeks).|Response-Evaluable population, defined as all participants who received at least 1 dose of any study drug, have measurable disease at baseline, and have at least one post-baseline M-protein measurement.||percentage of participants|||Number
744177|NCT00507416|Secondary|Percentage of Participants With a Complete Response|Participants with a best overall response of complete response, defined as negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow. Response was assessed by the Investigator using the IMWG uniform response criteria.|Response assessed every other cycle, for up to 13 cycles (49 weeks).|Response-Evaluable population, defined as all participants who received at least 1 dose of any study drug, have measurable disease at baseline, and have at least one post-baseline M-protein measurement.||percentage of participants|||Number
744178|NCT00507416|Secondary|Percentage of Participants With an Overall Response|"Overall response defined as a best overall response of complete response (CR), very good partial response (VGPR) or partial response (PR), assessed by the Investigator using the IMWG uniform response criteria.
CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow.
VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein plus urine M-protein level <100 mg per 24 hours (h).
PR requires 1 of the following:
≥50% reduction of serum M-protein and 24-h urinary M-protein by ≥ 90% or to <200 mg/24 h, or
If M-protein not measurable, a ≥50% decrease in the difference between involved and uninvolved FLC levels, or
If FLC not measurable, a ≥ 50% reduction in plasma cells, provided baseline bone marrow plasma cell percentage was ≥30%.
If present at baseline, a ≥50% reduction in the size of soft tissue plasmacytomas is also required."|Response assessed every other cycle for up to 13 cycles (49 weeks).|Response-Evaluable population, defined as all participants who received at least 1 dose of any study drug, have measurable disease at baseline, and have at least one post-baseline M-protein measurement.||percentage of participants|||Number
744179|NCT00507416|Primary|Progression Free Survival (PFS)|"PFS is defined as the time from randomization to disease progression or death, whichever occurs first. Participants who did not progress and were still alive at the cut-off date were censored at the date of last contact. Response was assessed by the Investigator using the International Myeloma Working Group (IMWG) uniform response criteria.
Progressive disease requires 1 of the following:
Increase of ≥ 25% from nadir in:
Serum M-component (absolute increase ≥ 0.5 g/dl)
Urine M-component (absolute increase ≥ 200 mg/24 hours)
In patients without measurable serum and urine M-protein levels the difference between involved and uninvolved free light chain (FLC) levels (absolute increase > 100 mg/dl)
Bone marrow plasma cell percentage (absolute % ≥ 10%)
Development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas.
Development of hypercalcemia (corrected serum calcium > 11.5 mg/dl) attributed solely to plasma cell proliferative disease"|From randomization until disease progression. Median follow-up time was 43 months.|Intent-to-treat (all randomized participants)||months||95% Confidence Interval|Median
744180|NCT00507429|Secondary|To Determine Percentage of 1 Year Survival||from randomization through end of study visit|Intent to treat||percentage of participants|||Number
744181|NCT00507429|Secondary|To Determine Progression Free Survival||from randomization through end of study visit||||||
744182|NCT00507429|Primary|Overall Survival||From randomization to date last known alive|All randomized subjects (the Intent-to-treat population) included in the analysis||months||95% Confidence Interval|Median
744183|NCT00507442|Secondary|Overall Survival|Overall survival is defined as time from the date of randomization to the date of death|Up to 48 weeks or until death|The modified intent-to-treat population is defined as phase 2 patients received at least one dose of any drug.||days||95% Confidence Interval|Median
744184|NCT00507442|Secondary|Probability of 1-year Survival||survival probability at 1 year after randomization|The modified intent-to-treat population is defined as phase 2 patients received at least one dose of any drug.||percentage of patients|||Number
747586|NCT00530842|Secondary|Static Lung Volumes (Percent)|Trough TGV/TLC (Thoracic Gas Volume over Total Lung Capacity) after 4 weeks (measured by bodyphlethysmography)|4 weeks|FAS using imputed values||Percent of TGV over TLC||Standard Error|Mean
744185|NCT00507442|Secondary|Progression-free Survival|"Progression-free survival is defined as time from the date of randomization to the date of the first documented progressive disease or death.
Disease progression requires any one or more of the following: serum m-protein increase >= 25% from nadir(absolute increase >= 0.5 g/dL); Urine m-protein increase >= 25% from nadir(absolute increase >= 200 mg/24 hr), bone marrow plasma cell percentage increase >= 25% from nadir(absolute increase >= 10%), new bone lesion or soft tissue plasmacytomas."|Up to 48 weeks or until disease progression/death|The modified intent-to-treat population is defined as phase 2 patients received at least one dose of any drug.||days||95% Confidence Interval|Median
744186|NCT00507442|Secondary|Time to Response|Time to response is defined as time from date of randomization to the date of the first documentation of a confirmed response. confirmed response is a response that has been observed on at least two consecutive assessments.|Up to 48 weeks or until disease response|Responders (patients achieved complete and partial response) in the response evaluable population.||days||Full Range|Median
744187|NCT00507442|Secondary|Time to Disease Progression|"Time to disease progression is defined as time from the date of randomization to the date of first documented progressive disease.
Disease progression requires any one or more of the following: serum m-protein increase >= 25% from nadir(absolute increase >= 0.5 g/dL); Urine m-protein increase >= 25% from nadir(absolute increase >= 200 mg/24 hr), bone marrow plasma cell percentage increase >= 25% from nadir(absolute increase >= 10%), new bone lesion or soft tissue plasmacytomas."|Up to 48 weeks or until disease progression|The modified intent-to-treat population is defined as phase 2 patients received at least one dose of any drug.||days||95% Confidence Interval|Median
744188|NCT00507442|Secondary|Duration of Response|"Duration of response is the time from date of first documented confirmed response to date of first documented progressive disease. A confirmed response is a response that has been observed on at least two consecutive assessments.
Disease progression requires any one or more of the following: serum m-protein increase >= 25% from nadir(absolute increase >= 0.5 g/dL); Urine m-protein increase >= 25% from nadir(absolute increase >= 200 mg/24 hr), bone marrow plasma cell percentage increase >= 25% from nadir(absolute increase >= 10%), new bone lesion or soft tissue plasmacytomas."|Up to 48 weeks or until disease progression|Responders (patients achieved complete and partial response) in the response evaluable population.||days||95% Confidence Interval|Median
744189|NCT00507442|Secondary|Number of Patients With Complete Response Rate + Near Complete Response Rate|"Complete response requires negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow.
Near Complete response requires positive immunofixation on the serum and/or urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow."|Up to 48 weeks or until disease progression|The response-evaluable population is defined as phase 2 patients with measurable disease at baseline and with at least 1 post baseline response assessment.||participants|||Number
744190|NCT00507442|Secondary|Number of Patients With Stringent Complete Response Rate|Stringent Complete Response is defined as complete response plus normal free light chain (kappa/lambda) ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.|Up to 48 weeks or until disease progression|The response-evaluable population is defined as phase 2 patients with measurable disease at baseline and with at least 1 post baseline response assessment.||participants|||Number
744191|NCT00507442|Secondary|Number of Patients With Overall Response|"Overall Response includes complete response and partial response.
Complete response requires negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow.
Partial response requires at least 50% reduction of serum M-protein and reduction in 24-h urinary M-protein by at least 90% or to < 200 mg per 24 hour."|Up to 48 weeks or until disease progression|The response-evaluable population is defined as phase 2 patients with measurable disease at baseline and with at least 1 post baseline response assessment.||participants|||Number
744192|NCT00507442|Secondary|Number of Patients With Adverse Events (AEs)|Evaluate the safety and tolerability of the combination therapy|From first dose of study drug through the 30 day post-treatment AE assessment visit|The safety population includes patients received any dose of any study drug.||participants|||Number
744193|NCT00507442|Primary|Number of Patients With Combined Complete Response and Very Good Partial Response|"Complete response requires negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow.
Very good partial response requires serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level < 100 mg per 24 h"|Up to 48 weeks or until disease progression|The response-evaluable population is defined as phase 2 patients with measurable disease at baseline and with at least 1 post baseline response assessment.||participants|||Number
744194|NCT00507455|Secondary|Change From Baseline in ICIQ-LUTSqol Overall Symptom Interference of Life Score|"Participants were asked to rate how much their urinary symptoms interfered overall with their everyday life on a scale from 0 (not at all) to 10 (a great deal).
Least squares (LS) means were adjusted for pooled center and the Baseline value."|Baseline and Weeks 4, 8 and 12|"Full analysis set (FAS) population with available data at Baseline and at each time point (indicated as N). End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method."||units on a scale||Standard Error|Least Squares Mean
744195|NCT00507455|Secondary|Change From Baseline in International Consultation on Incontinence Questionnaire - Lower Urinary Tract Symptom Quality of Life (ICIQ-LUTSqol) Symptom Score|"Quality of life was assessed by the ICIQ-LUTSqol questionnaire which consists of 19 questions regarding daily activities affected by urinary problems. Participants responded to each question on a scale from 1 (not at all) to 4 (a lot). The total symptom score ranges from 19 to 76, where larger scores correspond to a lesser quality of life).
Least squares (LS) means were adjusted for pooled center and the Baseline value."|Baseline and Weeks 4, 8 and 12|"Full analysis set (FAS) population with available data at Baseline and at each time point (indicated as N). End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method."||units on a scale||Standard Error|Least Squares Mean
744236|NCT00507559|Primary|Effectiveness: Composite Success Rate|Composite endpoint of delivery success, absence of Type I/III endoleak requiring intervention post-index procedure, absence of migration (>10mm), and absence of aneurysm rupture or conversion.This composite endpoint is compared to an estimated success rate of 80%.|12 months|||participants|||Number
792185|NCT00890721|Secondary|Participants With Adverse Events Through 72 Hours or Serious Adverse Events Through 30 Days||30 days||||||
744196|NCT00507455|Secondary|Change From Baseline in ICIQ-MLUTS Total Symptom Bother Score|"The degree to which urinary symptoms bothered participants was assessed by the ICIQ MLUTS questionnaire which consists of 13 symptom bother questions. Each question is answered by the participant on a scale from 0 (not at all) to 10 (a great deal). The total bother score ranges from 0 to 130, where larger scores correspond to worse outcomes.
Least squares (LS) means were adjusted for pooled center and the Baseline value."|Baseline and Weeks 4, 8 and 12|"Full analysis set (FAS) population with available data at Baseline and at each time point (indicated as N). End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method."||units on a scale||Standard Error|Least Squares Mean
744197|NCT00507455|Secondary|Change From Baseline in International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptom (ICIQ MLUTS) Total Symptom Score|"Male lower urinary tract symptoms were assessed by the ICIQ MLUTS questionnaire which consists of 13 questions regarding urinary symptoms. Each question is answered by the participant on a scale from 0 (never) to 4 (all the time). The total symptom score ranges from 0 to 52, where larger scores correspond to worse conditions.
Least squares (LS) means were adjusted for pooled center and the Baseline value."|Baseline and Weeks 4, 8 and 12|"Full analysis set (FAS) population with available data at Baseline and at each time point (indicated as N). End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method."||units on a scale||Standard Error|Least Squares Mean
744198|NCT00507455|Secondary|Change From Baseline in Volume Voided Per Micturition|"The mean volume voided per micturition was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
Least squares (LS) means were adjusted for pooled center and the Baseline value."|Baseline and Weeks 2, 4, 8 and 12|Full analysis set (FAS) population with available data at each time point. End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method.||mL||Standard Error|Least Squares Mean
744199|NCT00507455|Secondary|Change From Baseline in Number of Incontinence Episodes Per 24 Hours|"The mean number of incontinence episodes (the involuntary leakage of urine) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
Least squares (LS) means were adjusted for pooled center and the Baseline value."|Baseline and Weeks 2, 4, 8 and 12|Full analysis set (FAS) population who had 3-day averaged incontinence episodes >0 at Baseline and with available data at each time point. End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method.||incontinence episodes||Standard Error|Least Squares Mean
744200|NCT00507455|Secondary|Change From Baseline in Number of Urgency Episodes Per 24 Hours|"For each micturition and/or incontinence episode participants rated the degree of associated urgency (the sudden compelling desire to pass urine, which is difficult to defer) according to the following scale: 0: No Urgency, felt no need to empty my bladder but did so for another reason; 1: Mild urgency, could postpone passing water for as long as necessary; 2: Moderate urgency, could postpone passing water for a short while; 3: Severe urgency, could not postpone passing water; 4: Urge incontinence, leaked before reaching the toilet. An urgency episode is defined as an episode with urgency severity of three or higher.
The mean number of urgency episodes per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
Least squares (LS) means were adjusted for pooled center and the Baseline value."|Baseline and Weeks 2, 4, 8 and 12|Full analysis set (FAS) population with available data at each time point. End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method.||urgency episodes||Standard Error|Least Squares Mean
744201|NCT00507455|Secondary|Change From Baseline in Number of Micturitions Per 24 Hours|"A micturition is any voluntary urination, excluding episodes of incontinence only. The mean number of micturitions per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
Least squares (LS) means were adjusted for pooled center and the Baseline value."|Baseline and Weeks 2, 4, 8 and 12|Full analysis set (FAS) population with available data at each time point. End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method.||micturitions||Standard Error|Least Squares Mean
744202|NCT00507455|Secondary|Change From Baseline in Patient Perception of Bladder Condition (PPBC)|"The patient perception of bladder condition (PPBC) questionnaire asks participants to assess their bladder condition using a 6-point validated Likert scale which ranges from 1 (does not cause me any problems at all) to 6 (causes me many severe problems).
Least squares (LS) means were adjusted for pooled center and the Baseline value."|Baseline and Weeks 2, 4, 8 and 12|Full analysis set (FAS) population with available data at each time point. End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method.||units on a scale||Standard Error|Least Squares Mean
744203|NCT00507455|Secondary|Change From Baseline in IPSS Storage Score|"The IPSS is a validated global questionnaire used to assess the degree of “bother” from benign prostatic hyperplasia symptoms based on the answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The storage symptom score is the sum of the responses to 3 questions relating to storage symptoms (frequency, urgency and nocturia) and ranges from 0 to 15 (asymptomatic to very symptomatic).
Least squares (LS) means were adjusted for pooled center and the Baseline value."|Baseline and Weeks 2, 4, 8 and 12|Full analysis set (FAS) population with available data at each time point. End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method.||units on a scale||Standard Error|Least Squares Mean
744204|NCT00507455|Secondary|Change From Baseline in IPSS Voiding Score|"The IPSS is a validated global questionnaire used to assess the degree of “bother” from benign prostatic hyperplasia symptoms based on the answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The voiding score is the sum of the responses to 4 questions relating to urination (incomplete emptying, intermittency, weak stream and straining) and ranges from 0 to 20 (asymptomatic to very symptomatic).
Least squares (LS) means were adjusted for pooled center and the Baseline value."|Baseline and Weeks 2, 4, 8 and 12|Full analysis set (FAS) population with available data at each time point. End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method.||units on a scale||Standard Error|Least Squares Mean
744205|NCT00507455|Secondary|Change From Baseline in International Prostate Symptoms Score (IPSS)|"The IPSS is a validated global questionnaire used to assess the degree of “bother” from benign prostatic hyperplasia symptoms and is based on the answers to 7 questions concerning urinary symptoms:
Sensation of incomplete emptying
Repeat urinating after 2 hours (frequency)
Start and stop several times (intermittency)
Urgency
Weak stream
Straining
Nocturia
Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).
Least squares (LS) means were adjusted for pooled center and the Baseline value."|Baseline and Weeks 2, 4, 8 and 12|Full analysis set (FAS) population with available data at each time point. End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method.||units on a scale||Standard Error|Least Squares Mean
744206|NCT00507455|Secondary|Safety Assessed by Adverse Events (AEs), Electrocardiogram (ECG), Vital Signs, Physical Exam and Laboratory Tests|Abnormal laboratory parameters, vital signs or ECG data were defined as AEs if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. A serious AE was an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important. AEs were assessed by the Investigator for intensity as mild (no disruption of normal daily activities), moderate (affected normal daily activities) or severe (inability to perform daily activities) and for causal relationship to study drug.|From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).|Safety analysis set population consisted of participants who received at least 1 dose of double-blind treatment.||participants|||Number
744207|NCT00507455|Secondary|Change From Baseline to End of Treatment in Percent Bladder Voiding Efficiency (BVE)|"Percent Bladder Voiding Efficiency (BVE) is a product of bladder contractility against the urethral resistance and is measured according to the degree of bladder emptying. BVE is expressed as a percentage and is calculated using the formula:
Bladder Voiding efficiency = (Voided volume x 100)/maximum cystometric capacity.
A higher number indicates a higher voiding efficiency.
LS means were adjusted for pooled center and Baseline value."|Baseline and Week 12|Full analysis set (FAS) population; Last observation carried forward (LOCF) imputation was used.||Percent voiding efficiency||Standard Error|Least Squares Mean
744208|NCT00507455|Secondary|Change From Baseline to End of Treatment in Bladder Contractility Index (BCI)|"The Bladder Contractility Index (BCI) is a value used to measure the degree of contractility. BCI was calculated using the following formula:
BCI = pdetQmax + 5Qmax.
Strong contractility is a BCI > 150, normal contractility is a BCI of 100-150 and weak contractility is a BCI of < 100.
LS means were adjusted for pooled center and Baseline value."|Baseline and Week 12|Full analysis set (FAS) population; Last observation carried forward (LOCF) imputation was used.||units on a scale||Standard Error|Least Squares Mean
744209|NCT00507455|Primary|Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax)|The maximum flow rate (Qmax) during a micturition (urination) was recorded using uroflowmetry. A reduction in maximum flow rate may be due to an obstruction of the bladder outlet or a failure of the detrusor muscle to aid in expelling urine.|Baseline and Week 12|Full analysis set (FAS) population consisted of participants who received at least one dose of double-blind treatment and had urodynamic measurements at baseline and post-baseline on-treatment visit. Last observation carried forward (LOCF) imputation was used.||mL/sec||Standard Error|Least Squares Mean
744210|NCT00507455|Secondary|Change From Baseline in Post Void Residual Volume (PVR)|"Healthy micturitions result in complete emptying of the bladder. Post Void Residual (PVR) is the volume of urine retained after voiding (post-void residual urine). Post void residual volume was assessed by abdominal ultrasound. An increasing PVR over time is an indicator of abnormal bladder function or detrusor decompensation.
End-of-treatment is the last post-baseline assessment during the treatment period.
Least squares (LS) means were adjusted for pooled center and the Baseline value."|Baseline and Weeks 2, 4, 8 and 12|"Full analysis set (FAS) population with available data at each time point (as indicated by N). End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method."||mL||Standard Error|Least Squares Mean
744211|NCT00507455|Primary|Change From Baseline to End of Treatment in Detrusor Pressure at Maximum Flow Rate (PdetQmax)|Detrusor pressure (Pdet) measures the force the detrusor muscle is exerting. This pressure is required to expel urine from the bladder during normal voiding. A high detrusor pressure may be observed in the presence of outflow tract obstruction. Detrusor pressure at maximum urinary flow rate (PdetQmax) was evaluated using simultaneous recording of urinary voiding by an uroflowmeter during detrusor pressure evaluation by cystometry.|Baseline and Week 12|Full analysis set (FAS) population consisted of participants who received at least one dose of double-blind treatment and had both urodynamic measurements at baseline and one or both measured at any post-baseline on-treatment visit. Last observation carried forward (LOCF) imputation was used.||cmH2O||Standard Error|Least Squares Mean
744212|NCT00507507|Secondary|Occurrence of HBV Resistance Mutations|The development of HBV resistance mutations (occurrence of conserved site changes and/or polymorphic site changes) was analyzed for the overall study period (through Week 192).|Baseline to Week 192|Genotyping was attempted for all participants with HBV DNA ≥ 400 copies/mL at Week 48, 96, 144, 192 and/or the early discontinuation visit, and for all participants (with HBV DNA ≥ 400 copies/mL) after Week 192 who were on study for at least 216 weeks when the last participant reached Week 192.||participants|||Number
744213|NCT00507507|Secondary|Number of Participants With Seroconversion to Antibody to HBsAg (Anti-HBs) at Weeks 48, 96, 144, and 192|The number of participants with seroconversion to anti-HBs at Weeks 48, 96, 144, and 192 was analyzed. Seroconversion to anti-HBs was defined as change of detectable antibody to HBsAg from negative to positive.|Weeks 48, 96, 144, and 192|Full Analysis Set||participants|||Number
744214|NCT00507507|Secondary|Number of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48, 96, 144, and 192|The number of participants with HBsAg loss at Weeks 48, 96, 144, and 192 was analyzed. Loss of HBsAg was defined as change of detectable HBsAg from positive to negative.|Weeks 48, 96, 144, and 192|Full Analysis Set||participants|||Number
744237|NCT00507689|Secondary|Percentage of Participants With Normal ALT at Week 96|Range of normal ALT was 6 to 34 U/L for females 18-69 years of age, and 6 to 32 U/L for females over age 69. Range of normal ALT was 6 to 43 U/L for males 18-69 years of age, and 6 to 35 U/L for males over age 69.|Week 96|Participants in the Full Analysis Set with available data at Week 96 were analyzed.||percentage of participants|||Number
744215|NCT00507507|Secondary|Number of Participants With Seroconversion to Antibody Against HBeAg (Anti-HBe) at Weeks 48, 96, 144, and 192|"The number of participants with seroconversion to anti-HBe at Weeks 48, 96, 144, and 192 was analyzed. Seroconversion to anti-HBe was defined as change of detectable antibody to HBeAg from negative to positive.
No statistical analysis is presented for Week 48 because no participants met the criteria at that time point."|Weeks 48, 96, 144, and 192|Participants in the Full Analysis Set who were HBeAg positive at baseline were analyzed.||participants|||Number
744216|NCT00507507|Secondary|Number of Participants With Hepatitis B e Antigen (HBeAg) Loss at Weeks 48, 96, 144, and 192|"The number of participants with HBeAg loss at Weeks 48, 96, 144, and 192 was analyzed. Loss of HBeAg was defined as change of detectable HBeAg from positive to negative.
No statistical analysis is presented for Week 48 because no participants met the criteria at that time point."|Weeks 48, 96, 144, and 192|Participants in the Full Analysis Set who were HBeAg positive at baseline were analyzed.||participants|||Number
744217|NCT00507507|Secondary|Number of Participants With Normal Alanine Aminotransferase (ALT) at Weeks 48, 96, 144, and 192|Range of normal ALT was 6 to 34 U/L for females, 6 to 43 U/L for males. Participants with missing data were considered to have failed to achieve the criteria for evaluation.|Weeks 48, 96, 144, and 192|Full Analysis Set||participants|||Number
744218|NCT00507507|Secondary|Change From Baseline in HBV DNA at Week 192|The change from baseline in HBV DNA at Week 192 was analyzed.|Baseline to Week 192|Participants in the Full Analysis Set with evaluable change data at Week 96 were analyzed.||log_10 copies/mL||Standard Deviation|Mean
744219|NCT00507507|Secondary|Change From Baseline in HBV DNA at Week 144|The change from baseline in HBV DNA at Week 144 was analyzed.|Baseline to Week 144|Participants in the Full Analysis Set with evaluable change data at Week 96 were analyzed.||log_10 copies/mL||Standard Deviation|Mean
744220|NCT00507507|Secondary|Change From Baseline in HBV DNA at Week 96|The change from baseline in HBV DNA at Week 96 was analyzed.|Baseline to Week 96|Participants in the Full Analysis Set with evaluable change data at Week 96 were analyzed.||log_10 copies/mL||Standard Deviation|Mean
744221|NCT00507507|Secondary|Change From Baseline in HBV DNA at Week 48|The change from baseline in HBV DNA at Week 48 was analyzed.|Baseline to Week 48|Participants in the Full Analysis Set with evaluable change data at Week 48 were analyzed.||log_10 copies/mL||Standard Deviation|Mean
744222|NCT00507507|Secondary|Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 96, 144, and 192|The percentage of participants with HBV DNA < 169 copies/mL at Weeks 48, 96, 144, and 192 was analyzed. Participants with missing data were considered to have failed to achieve the criteria for evaluation.|Weeks 48, 96, 144, and 192|Full Analysis Set||percentage of participants|||Number
744223|NCT00507507|Secondary|Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 96, and 144|The percentage of participants with HBV DNA < 400 copies/mL at Weeks 48, 96, and 144 was analyzed. Participants with missing data were considered to have failed to achieve the criteria for evaluation.|Weeks 48, 96, and 144|Full Analysis Set||percentage of participants|||Number
744224|NCT00507507|Primary|Percentage of Participants With HBV DNA < 400 Copies/mL at Week 192|The percentage of participants with HBV DNA < 400 copies/mL at Week 192 was analyzed. Participants with missing data were considered to have failed to achieve the criteria for evaluation.|Week 192|Full Analysis Set: participants who were randomized and received at least one dose of study drug||percentage of participants|||Number
744225|NCT00507546|Secondary|Change in Subjective Morning Alertness|Measured as the median of the average morning alertness (measured from 1-7 on the Stanford Sleepiness Scale, a Likert-like scale in which higher values are lower alertness) of the three weeks of either placebo or ramelteon treatment|10 weeks|||units on a scale||Full Range|Median
744226|NCT00507546|Primary|Amount of Wakefulness After Sleep Onset (WASO)|Measured as the median of the average WASO of the three weeks of either placebo or ramelteon treatment|10 weeks|All participants who completed the entire protocol.||Minutes||Full Range|Median
744227|NCT00507559|Secondary|Effectiveness: Thrombosis|Percent (number) of subjects experiencing thrombosis through 5 years post-index procedure|5 years|Events classified by the clinical events committee as thrombosis in device, embolism, device occlusion, vascular occlusion and thrombosis were included in the number of patients affected||participants|||Number
744228|NCT00507559|Secondary|Effectiveness: Type I Endoleak and Type III Endoleak|Percent (number) of subjects experiencing type I endoleak (inadequate or ineffective seal of graft) or III endoleak (inadequate seal of graft joints or graft rupture) requiring intervention through 12 months post-index procedure|12 months|Denominator is the number of subjects with adequate CT imaging available at 12 months||participants|||Number
744229|NCT00507559|Secondary|Effectiveness: Prosthesis Migration|Percent (number) of subjects experiencing prothesis migration at 12 months post-index procedure|12 months|The denominator is the number of subjects with adequate CT imaging available at 12 months||participants|||Number
744230|NCT00507559|Secondary|Effectiveness: EndoStaple Stent/Fracture|Percent (number) of subjects experiencing an EndoStaple stent/fracture at 12 months post-index procedure|12 months|Denominator is number of subjects with adequate x-ray imaging available at 12 months||participants|||Number
744231|NCT00507559|Secondary|Effectiveness: Aneurysm Change|Percent (number) of subjets experiencing aneurysm change (defined as increase in maximum diameter of >5mm) at 12 months post-index procedure|12 months|Denominator is number of subjects with assessable imaging. Films are not assessable for aneurysm change if the 30-day scan is not available as a baseline.||participants|||Number
744232|NCT00507559|Secondary|Effectiveness: Aneurysm Rupture|Percent (number) of subjects experiencing aneurysm rupture through 12 months post-index procedure|12 months|143 reflects the number of subjects with data for the 12 month visit.||participants|||Number
744233|NCT00507559|Secondary|Effectiveness: Surgical Conversion|"Percent (number) of subjects undergoing surgical conversion through 12 months post-index procedure.
Conversion is defined as the patient undergoing open surgical aneurysm repair with partial or complete removal of the study device."|12 months|143 reflects the number of subjects with data for the 12 month visit.||participants|||Number
744234|NCT00507559|Secondary|Safety: SAE (Serious Adverse Event)|Percent (number) of subjects experiencing one or more serious adverse event through 5 years post-index procedure|5 years|||participants|||Number
744235|NCT00507559|Primary|Safety: MAE (Major Adverse Event)|Percentage (number) of subjects experiencing one or more of major adverse events within the first 30 days post-index procedure compared to the open surgical repair historical group|30 days|||participants|||Number
744238|NCT00507689|Secondary|Percentage of Participants With Normal ALT at Week 72|Range of normal ALT was 6 to 34 U/L for females 18-69 years of age, and 6 to 32 U/L for females over age 69. Range of normal ALT was 6 to 43 U/L for males 18-69 years of age, and 6 to 35 U/L for males over age 69.|Week 72|Participants in the Full Analysis Set with available data at Week 72 were analyzed.||percentage of participants|||Number
744239|NCT00507689|Secondary|Percentage of Participants With HBV DNA < 169 Copies/mL at Week 96||Week 96|Participants in the Full Analysis Set with available data at Week 96 were analyzed.||percentage of participants|||Number
744240|NCT00507689|Secondary|Percentage of Subjects With HBV DNA < 169 Copies/mL at Week 72||Week 72|Participants in the Full Analysis Set with available data at Week 72 were analyzed.||percentage of participants|||Number
744241|NCT00507689|Secondary|Percentage of Participants With HBV Recurrence at Week 96|HBV recurrence was defined as HBV DNA ≥ 400 at the Week 96 visit.|Week 96|Participants in the Full Analysis Set with available data at Week 96 were analyzed.||percentage of participants|||Number
744242|NCT00507689|Primary|Percentage of Participants With HBV Recurrence Prior to or at Week 72|HBV recurrence was defined as either HBV DNA ≥ 400 at 2 consecutive visits before Week 72, or HBV DNA ≥ 400 at the Week 72 visit.|Pretreatment baseline through Week 72|Full Analysis Set||percentage of participants|||Number
744243|NCT00507767|Primary|Number of Participants With Progression-free Survival at 12-weeks|Progression-free survival (PFS) is defined as stable disease or better. Participants who have received at least one dose of dasatinib and who die or leave the study before 12 weeks will be counted as having progressive disease.|At 12-weeks|Analysis per protocol.||participants|||Number
744244|NCT00507819|Secondary|Change From Baseline in Mean Minute Ventilation (L/Min) at 6 Weeks|Minute ventilation measurements were taken at peak exercise. Subjects were exercised to maximal volition with an electronically braked cycle ergometer. The protocol consisted of 3 minutes of pedaling in an unloaded state followed by a ramp increase in work rate (watts) to maximal exercise. Metabolic and ventilatory data were obtained throughout the exercise study and for the first 2 minutes of recovery on a breath-by-breath basis with a metabolic cart.|Baseline and 6 Weeks|||L/min||Standard Deviation|Mean
744245|NCT00507819|Secondary|Change From Baseline in Mean Respiratory Rate (Breaths/Min) at 6 Weeks|Respiratory rate was measured at peak exercise. Subjects were exercised to maximal volition with an electronically braked cycle ergometer. The protocol consisted of 3 minutes of pedaling in an unloaded state followed by a ramp increase in work rate (watts) to maximal exercise. Metabolic and ventilatory data were obtained throughout the exercise study and for the first 2 minutes of recovery on a breath-by-breath basis with a metabolic cart.|Baseline and 6 Weeks|||breaths/min||Standard Deviation|Mean
744246|NCT00507819|Secondary|Change From Baseline in Mean Heart Rate (Bpm) at 6 Weeks|Heart rate was measured at peak exercise. Subjects were exercised to maximal volition with an electronically braked cycle ergometer. The protocol consisted of 3 minutes of pedaling in an unloaded state followed by a ramp increase in work rate (watts) to maximal exercise. Metabolic and ventilatory data were obtained throughout the exercise study and for the first 2 minutes of recovery on a breath-by-breath basis with a metabolic cart.|Baseline and 6 Weeks|||bpm||Standard Deviation|Mean
744247|NCT00507819|Primary|Change From Baseline in Mean Oxygen Consumption (mL/kg/Min) at 6 Weeks|Oxygen consumption measurements were taken at peak exercise. Subjects were exercised to maximal volition with an electronically braked cycle ergometer. The protocol consisted of 3 minutes of pedaling in an unloaded state followed by a ramp increase in work rate (watts) to maximal exercise. Metabolic and ventilatory data were obtained throughout the exercise study and for the first 2 minutes of recovery on a breath-by-breath basis with a metabolic cart.|Baseline and 6 Weeks|||mL/kg/min||Standard Deviation|Mean
744248|NCT00508001|Secondary|Overall Survival|Overall survival defined as the time from randomization (start of treatment) until death from any cause.|assessed up to 360 days|The analysis performed in the intent-To-Treat population.||Days||95% Confidence Interval|Median
744249|NCT00508001|Secondary|Progression-free Survival|Progression-free survival defined as the period from date of randomization(start of treatment) to date of disease progression or death.|from the date of randomisation to the date of documented disease progression or death for any cause|The analysis has been performed in the Intent-To-Treat (ITT) population.||Days||95% Confidence Interval|Mean
744250|NCT00508001|Secondary|Objective Response Rate|"Objective Response rate defined as percentage of patients with Complete Response [CR] or Partial Response [PR] based on Response Evaluation Criteria in Solid Tumours (RECIST).
Partial response (PR) must have ≥ 30% decrease in the sum of longest diameter of all target lesions as assessed by Magnetic Resonance Imaging (MRI). Complete response (CR) must have disappearance of all target and non-target lesions as assessed by MRI."|After 16 weeks of treatment.|The analysis has been performed in the Intent-To-Treat (ITT) population.||percentage of patients|||Number
744251|NCT00508001|Primary|Tumour Stabilisation Rate|"Tumour stabilisation rate calculated as percentage of patients with best objective tumour response (Complete Response, Partial Response or Stable Disease) for >=16 weeks based on Response Evaluation Criteria in Solid Tumours (RECIST).
Complete Response - Disappearance of all target lesions; Partial Response - >=30% decrease in the sum of longest diameter of target lesions; Progressive Disease - >=20% increase in the sum of longest diameter of target lesions; Stable Disease - neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD."|After 16 weeks of treatment.|The analysis has been performed in the Intent-To-Treat (ITT) population.||percentage of patients|||Number
744252|NCT00508027|Primary|Change in Serum Creatinine Levels|Change in serum creatinine (Cr) levels after treatment with simvastatin|Baseline, 21 days|||mg/dL||Standard Deviation|Mean
744253|NCT00508027|Primary|Change in Serum Alanine Transaminase (ALT) Levels|Change in serum alanine transaminase (ALT) after treatment with simvastatin|Baseline, 21 days|||U/L||Standard Deviation|Mean
744254|NCT00508027|Primary|Change in Serum Creatine Kinase Levels|Change in serum creatine kinase (CK) levels after treatment with simvastatin|Baseline, 21 days|||U/L||Standard Deviation|Mean
744255|NCT00508027|Primary|Change in Hemoglobin Level|Change in plasma hemoglobin (Hb) level after treatment with simvastatin|Baseline, 21 days|||gm/dL||Standard Deviation|Mean
744256|NCT00508027|Primary|Change in Total Cholesterol Level|Change in serum total cholesterol level after treatment with simvastatin|Baseline, 21 days|||mg/dL||Standard Deviation|Mean
744257|NCT00508027|Other Pre-specified|Change in Plasma TF Levels|Change in plasma tissue factor (TF) levels after treatment with simvastatin|Baseline, 21 days|||pg/mL||Standard Deviation|Mean
744262|NCT00508027|Other Pre-specified|Change in Plasma NOx Levels|Measurements of the levels of plasma nitric oxide metabolites (NOx), high sensitivity C-reactive protein (hs-CRP), interleukin-6 (IL-6), vascular cell adhesion molecule-1 (VCAM-1), tissue factor (TF) and vascular endothelial growth factor (VEGF)were performed before and after simvastatin treatment. Changes in mean plasma biomarker levels were assessed for each dose level; however, dose level 3 results were not analyzed, as only 2 subjects were enrolled in this dose group.|Baseline, 21 days|All participants for whom plasma biomarker levels were recorded at baseline and 21 days||micromolar||Standard Deviation|Mean
744263|NCT00508118|Secondary|Transcranial Doppler Measurements||Day of surgery through discharge|No participants were analyzed due to study terminated early.|||||
744264|NCT00508118|Secondary|Cerebral Oximetry Measurements||Day of surgery through discharge|No participants were analyzed due to study terminated early.|||||
744265|NCT00508118|Secondary|Bispectral Index Scores (BIS)||Day of surgery through discharge|No participants were analyzed due to study terminated early.|||||
744266|NCT00508118|Secondary|Time Points for SSEP Latency and Amplitude Changes||Day of surgery through discharge|No participants were analyzed due to study terminated early.|||||
744267|NCT00508118|Secondary|Time Points of EEG Patterns||Day of surgery through discharge|No participants were analyzed due to study terminated early.|||||
744268|NCT00508118|Secondary|Temperature at Which Ablation of(SSEP)Occurs||Day of surgery through discharge|No participants were analyzed due to study terminated early.|||||
744269|NCT00508118|Secondary|Temperature at Which ECS Occurs||Day of surgery through discharge|No participants analyzed due to study terminated early.|||||
744270|NCT00508118|Primary|Duration From Initiation of Cardiopulmonary Bypass (CPB) to Electrocerebral Silence (ECS), Defined as no Discernable Electroencephalographic Activity at an Amplification of 2 Micro Volts (μV)/mm, Confirmed for 3 Minutes||Day of surgery|3 SUBJECTS PER PROTOCOL.||Time (minutes)||95% Confidence Interval|Median
744271|NCT00508144|Primary|Objective Response Rate (OR) Where OR=CR+PR: Number of Participants With Responses of Complete Response (CR) and Partial Response (PR)|"Complete Response (CR): Complete disappearance of all measurable & non-measurable disease; No new lesions; No disease related symptoms; Normalization of markers & other abnormal lab values.
Partial Response (PR): Applies only to those with at least one measurable lesion. >/= 30% decrease under baseline of sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. All target measurable lesions assessed using same techniques as baseline.
Progression: 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using same techniques as baseline. Unequivocal progression of non-measurable disease in opinion of treating physician.
Evaluated for symptoms 1-2 times per week while receiving treatment then 2 weeks after stopping study treatment (expected 4 cycles)."|Evaluated with 3 week treatment cycles, up to 4 cycles or 12 weeks|Of 58 eligible participants, only 54 treated were available for response and five (5) experienced an early death, five (5) were later deemed inevaluable, and two had an indeterminate response.||Participants|||Count of Participants
744272|NCT00508157|Secondary|Mean Change From Baseline in the Impact of Weight on Quality of Life (IWQoL-Lite) Scale Through Week 16|IWQoL-Lite is a 31-item self-report inventory to assess the impact of weight on quality of life among patients with obesity. Subscales include: Physical Function, Self Esteem, Sexual Life, Public Distress and Work. The rescaled IWQoL-Lite Total Score is determined by the sum of the 1 to 5 scores on all 31 items and rescaling this sum to a 0-100 scoring with 0=the poorest and 100=the best quality of life. A change of 7.8 to 12.0 points on the rescaled IWQoL-Lite Total Score=a meaningful improvement. A change of -4.5 to -7.6 on the rescaled IWQoL-Lite Total Score=a meaningful deterioration.|Baseline, Week 4, Week 8, Week 12, Week 16|This measure was not analyzed because the study was terminated early and there were insufficient data to draw meaningful conclusions.|||||
744273|NCT00508157|Secondary|Mean Change From Baseline in Subjective Well-Being Under Neuroleptics Scale (SWN-short Form) Through Week 16|The SWN-short form is a 20-item self-report instrument that measures subjective well-being under neuroleptics. 10 positive and 10 negative items cover 5 health domains (subscales) (4 items each): emotional regulation, self-control, mental functioning, social integration, and physical functioning. Individual scores range from 1 (not at all) to 6 (very much). With negative item scores being reversed, Subscale scores range from 4 to 24 and Total score ranges from 20 to 120.|Baseline, Week 4, Week 8,Week 12, Week 16|This measure was not analyzed because the study was terminated early and there were insufficient data to draw meaningful conclusions.|||||
744274|NCT00508157|Secondary|Mean Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale Through Week 16|A CGI-S assessment (a 7-point scale to evaluate the severity of symptoms) was performed at baseline (1=normal; 7=among the most extremely ill patients). A decrease in value indicates improvement.|Baseline, Week 4, Week 8, Week 12, Week 16|This measure was not analyzed because the study was terminated early and there were insufficient data to draw meaningful conclusions.|||||
744275|NCT00508157|Secondary|Median Change From Baseline in Body Mass Index (BMI) Through Week 16||Baseline, Week 4, Week 8, Week 12, Week 16|This measure was not analyzed because the study was terminated early and there were insufficient data to draw meaningful conclusions.|||||
744276|NCT00508157|Secondary|Mean Change From Baseline in Body Weight Through Week 16||Baseline, Week 4, Week 8, Week 12, Week 16|This measure was not analyzed because the study was terminated early and there were insufficient data to draw meaningful conclusions.|||||
744277|NCT00508157|Secondary|Mean Change From Baseline for Fasting Glucose Levels Through Week 16||Baseline, Week 4, Week 8, Week 12, Week 16|This measure was not analyzed because the study was terminated early and there were insufficient data to draw meaningful conclusions.|||||
744278|NCT00508157|Secondary|Mean Percent Change From Baseline in Fasting Lipid Parameters Through Week 16|Mean percent change from baseline in total cholesterol, low-density lipoprotein (LDL), HDL, and triglycerides.|Baseline, Week 4, Week 8, Week 12, Week 16|This measure was not analyzed because the study was terminated early and there were insufficient data to draw meaningful conclusions.|||||
744314|NCT00508651|Secondary|Geometric Mean Titers of Serum Antibodies to HPIV3 Day 28 Post Dose 1|Post-Dose 1 GMT of HAI antibody to HPIV3|Day 28-34 after Dose 1 (Dose 1 was on Day 0)|Immunogenicity population was randomized participants who received investigational product, did not have a protocol violation that would affect interpretation of immunogenicity results, and had valid HAI results. HAI results obtained on/after detection of wild-type HPIV3 were not considered valid. A value of 2 was assigned for HAI titers < 4.||GMT||95% Confidence Interval|Mean
744279|NCT00508157|Secondary|Number of Participants Remaining on Metabolic Syndrome at Week 16|Metabolic syndrome is defined as the presence of at least 3 out of the following Adult Treatment Panel III-A (ATP III-A) criteria (all of which are to be assessed at the same visit): waist >102 cm in males, >88 cm in females; blood pressure (BP) systolic BP ≥130 or diastolic BP ≥85 mm Hg; fasting HDL <40 mg/dL in males, <50 mg/dL in females; fasting triglycerides ≥150 mg/dL; fasting glucose ≥100 mg/dL, and/or the start of a treatment for any of the parameters of metabolic syndrome during the course of the study.|Week 16|LOCF, Safety Sample For handling missing values, the metabolic syndrome is assumed to be ongoing unless there is enough data to support the resolution of the metabolic syndrome.||participants|||Number
744280|NCT00508157|Primary|Mean Percent Change From Baseline in Fasting Non-high Density Lipoprotein (HDL) Cholesterol at Week 16|Non-HDL cholesterol was calculated as fasting Total Cholesterol minus fasting HDL Cholesterol.|Baseline, Week 16|Last Observation Carried Forward (LOCF) data set, Non-HDL measurements obtained after start of a treatment with a lipid-lowering agent were excluded; last measurement prior was used for LOCF analyses. Baseline data was carried forward for LOCF analysis for subjects for whom no on-treatment measurements for fasting non-HDL cholesterol was available.||percent change||Standard Error|Mean
744281|NCT00508274|Secondary|Central Nervous System as First Site of Relapse|Number of participants who have Central Nervous System metastasis as the first site of relapse. CT, Magnetic Resonance Imaging, etc. were used for the assessment.|Baseline; every 6 weeks for the first 36 weeks and then every 12 weeks until disease progression. The maximum time participants were followed was 11.07 months.|Intent-to-Treat (ITT) Population: all participants who received at lease one dose of investigational product||participants|||Number
744282|NCT00508274|Secondary|Duration of Response|Duration of response is defined as the time of first documentation of disease response until the date of disease progression or death due to breast cancer, whichever occurs first.|Baseline; every 6 weeks for the first 36 weeks and then every 12 weeks until disease progression. The maximum time participants were followed was 11.07 months.|Intent-to-Treat (ITT) Population: all participants who received at lease one dose of investigational product||Months||Full Range|Median
744283|NCT00508274|Secondary|Time to Response|Time to response is defined as the time from first dose date until first documentation of disease response.|Baseline; every 6 weeks for the first 36 weeks and then every 12 weeks until disease progression. The maximum time participants were followed was 11.07 months.|Intent-to-Treat (ITT) Population: all participants who received at lease one dose of investigational product||Months||Full Range|Median
744284|NCT00508274|Secondary|Six Months Progression-Free Survival|Six Months Progression-Free Survival is defined as the percentage of surviving participants who are free of disease progression longer than six months (greather than 180 days) after the first start date of study treatment.|Baseline; every 6 weeks for the first 36 weeks and then every 12 weeks until disease progression. The maximum time participants were followed was 11.07 months.|Intent-to-Treat (ITT) Population: all participants who received at least one dose of investigational product||Percentage of participants||95% Confidence Interval|Mean
744285|NCT00508274|Secondary|Progression-Free Survival (PFS)|PFS is defined as the time from first dose date until the date of disease progression or death due to any reason, whichever occurs first.|Baseline; every 6 weeks for the first 36 weeks and then every 12 weeks until disease progression. The maximum time participants were followed was 11.07 months.|Intent-to-Treat (ITT) Population: all participants who received at least one dose of investigational product||Months||Full Range|Median
744286|NCT00508274|Primary|Clinical Benefit Rate (CBR)|"CBR is defined by the percentage of participants achieving either a confirmed tumor reponse or stable disease (SD) for at least 24 weeks. Response Criteria in Solid Tumors (RECIST) is a system for measuring tumor shrinkage or progression in terms of the longest dimensions of the tumor on imaging scans such as computerized tomography (CT). A partial response requires a decrease of 30% or more, Progression requires an increase of at least 20%, and Stable disease falls in between these two. All responses have a repeat assessment to confirm the response."|Baseline; every 6 weeks for the first 36 weeks and then every 12 weeks until disease progression. The maximum time participants were followed was 11.07 months.|Intent-to-Treat (ITT) Population: all participants who received at least one dose of investigational product||Percentage of participants||95% Confidence Interval|Mean
744287|NCT00508391|Primary|Percent of Subjects That Did Not Experience an Adverse Event That Require Additional Invasive Intervention to Resolve, Specifically Related to the Interventricular Delay Feature of the Lumax HF-T Heart Failure Device|The purpose of primary endpoint two is to evaluate adverse events that require additional invasive intervention to resolve, specifically those events that are directly related to the interventricular delay feature of the Lumax HF-T heart failure device. These adverse events include any software issues related to the programming of the interventricular delay or any event that occurs after optimization of the interventricular delay and that can be directly attributed to the use of the feature.|60 days after enrollment|||Percent of Subjects|||Number
744288|NCT00508391|Primary|"Percentage of Subjects Classified as Not Worsened for Changes in the Minnesota Living With Heart Failure Questionnaire and Six-minute Walk Distance Between Periods of Optimized and Simultaneous Biventricular Pacing"|"The purpose is to evaluate the effectiveness of optimized pacing (OPT) compared to simultaneous pacing (SIM). The hypothesis is evaluated based on a responder classification. Subjects are classified not worsened if after 30 days of OPT the quality of life (QOL) score is no more than 10 points higher and the six-minute walk distance is no more than 35 meters lower than after 30 days of SIM. The Minnesota Living with Heart Failure questionnaire, a 21 question patient-completed survey, was used for QOL. Each question had a possible score of 0 (best) to 5 (worst), for a total of 0 to 105."|60 days after enrollment|Study utilized an intention-to-treat analysis. 111 out of 122 enrolled subjects completed the primary endpoint follow-up. 106 of these subjects met analysis criteria based on paired quality of life and six-minute walk data at the one and two month visits. Subjects not included in analysis either withdrew consent or had incomplete study measures.||Percent of Subjects|||Number
744289|NCT00508404|Secondary|Resection Rate|The percentage of participants who underwent a surgical procedure that resulted in partial reduction or complete eradication of all metastatic disease.|From enrollment until the data cut-off date of 18 June 2009; median follow-up time was 34 weeks.|Primary Analysis Set||percentage of participants||95% Confidence Interval|Number
745294|NCT00515216|Secondary|Genetic Polymorphisms That May Alter Treatment Outcomes (Partial Response)|This outcome looks at what genotypes of the XRCC1 c.1196G>A (rs25487) gene had a partial response.|4 years|9 out of 25 participants had a partial response.||participants|||Number
744290|NCT00508404|Secondary|Time to Disease Relapse Following Surgical Intervention|Calculated only for those participants who underwent surgical intervention, and defined as the time from the date of first post-intervention radiographic disease assessment to the date of first observed PD. Participants with no post-intervention disease assessment had their time to relapse set to zero and censored in the analysis. Participants that had evidence of progression / recurrence at their first post-intervention disease assessment had a time to relapse of zero. For participants who had not progressed by the analysis data cut-off date, time to relapse was censored at the date of their last evaluable disease assessment. Time to relapse was analyzed using Kaplan-Meier metjhods.|From enrollment until the data cut-off date of 18 June 2009; median follow-up time was 34 weeks.|Primary Analysis Set participants who underwent surgery||months||95% Confidence Interval|Median
744291|NCT00508404|Secondary|Time to Treatment Failure|Time to treatment failure is defined as the time from enrollment to the date the decision was made to end the treatment phase for any reason. For participants who remained in the treatment phase at the analysis data cut-off date, time to treatment failure was censored at the date of their last on-study assessment. Time to treatment failure was analyzed using Kaplan-Meier methods.|From enrollment until the data cut-off date of 18 June 2009; median follow-up time was 34 weeks.|Primary Analysis Set||months||95% Confidence Interval|Median
744292|NCT00508404|Secondary|Duration of Stable Disease|Duration of stable disease was calculated only for participants with a best response of stable disease and is defined as the time from enrollment to first observed PD. For participants who did not progress by the analysis data cut-off date, duration of SD was censored at their last evaluable disease assessment date. Duration of stable disease was estimated using Kaplan-Meier methods.|Tumor response was assessed at Week 8 and every 8 weeks to Week 48 and 3 monthly thereafter until disease progression; median follow-up time was 34 weeks.|KRAS Tumor Response Analysis Set with a best response of SD||months||95% Confidence Interval|Median
744293|NCT00508404|Secondary|Time to Disease Progression|Time to progression is the time from the enrollment date to the date of first observed progression. For participants who had not progressed by the analysis data cutoff date, time to progressive disease was censored at their last evaluable disease assessment date. Time to disease progression was analyzed using Kaplan-Meier methods.|From enrollment until the data cut-off date of 18 June 2009; median follow-up time was 34 weeks.|Primary Analysis Set||months||95% Confidence Interval|Median
744294|NCT00508404|Secondary|Progression-free Survival|Progression-free survival is the time from the date of enrollment to the date of first observed progression or death, whichever comes first. Participants who were alive and did not progress by the analysis data cut-off date were censored at the last evaluable disease assessment date. Progression-free survival was analyzed using Kaplan-Meier methods.|From enrollment until the data cut-off date of 18 June 2009; median follow-up time was 34 weeks.|Primary Analysis Set (all participants who provided informed consent, enrolled, received at least 1 dose of panitumumab, and had evaluable KRAS status data)||months||95% Confidence Interval|Median
744295|NCT00508404|Secondary|Time to Initial Objective Response|Time to response is the time from the date of enrollment to the date of first confirmed complete or partial response. Participants with a best response of stable disease at the analysis data cut-off date were censored at their last assessment of SD and participants with all other categories of best response were censored at the maximum observed time to a first confirmed response among all responders. Time to initial objective response was analyzed using Kaplan-Meier methods.|Tumor response was assessed at Week 8 and every 8 weeks to Week 48 and 3 monthly thereafter until disease progression; median follow-up time was 34 weeks.|KRAS Tumor Response Analysis Set||months||95% Confidence Interval|Median
744296|NCT00508404|Secondary|Duration of Response|Duration of response was calculated only for those participants who had a confirmed complete or partial response, and is defined as the time from first confirmed response to first observed progression. For participants who responded and did not progress by the analysis data cut-off date, duration of response was censored at their last evaluable disease assessment date. Duration of response was analyzed using the Kaplan-Meier method.|Tumor response was assessed at Week 8 and every 8 weeks to Week 48 and 3 monthly thereafter until disease progression; median follow-up time was 34 weeks.|KRAS Tumor Response Analysis Set with an objective response (CR or PR)||months||95% Confidence Interval|Median
744297|NCT00508404|Secondary|Disease Control Rate|"The percentage of participants whose best response was either a complete or partial response or stable disease, based on modified RECIST v1.0 criteria as assessed by the Investigator.
Stable diease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD of target lesions and no progression of existing non-target lesions and no new lesions, or, the persistence of 1 or more non-target lesions not qualifying for either CR or PD if no target lesions were identified at Baseline."|Tumor response was assessed at Week 8 and every 8 weeks to Week 48 and 3 monthly thereafter until disease progression; median follow-up time was 34 weeks|KRAS Tumor Response Analysis Set||percentage of participants||95% Confidence Interval|Number
744298|NCT00508404|Secondary|Objective Response by 17 Weeks|The percentage of participants with a best response of complete response or partial response by Week 17. Disease assessments are based on investigator review of scans using modified RECIST V1.0 criteria. A complete or partial response was confirmed no less than 4-weeks after the criteria for response were first met. Participants with no post-baseline assessment were considered non-responders.|Up to Week 17|KRAS Tumor Response Analysis Set||percentage of participants||95% Confidence Interval|Number
744315|NCT00508651|Secondary|Geometric Mean Titers (GMTs) of Serum HAI Antibodies to HPIV3 at Baseline|Pre-dose GMT of HAI antibody to HPIV3|Baseline (Day 0 prior to Dose 1)|Immunogenicity population was randomized participants who received investigational product, did not have a protocol violation that would affect interpretation of immunogenicity results, and had valid HAI results. HAI results obtained on/after detection of wild-type HPIV3 were not considered valid. A value of 2 was assigned for HAI titers < 4.||GMT||95% Confidence Interval|Mean
744316|NCT00508651|Secondary|Number of Nasal Wash Samples Containing Vaccine-like Virus in the Absence of Admixture With Wild-type HPIV3 in Which the Vaccine-like Virus Was Phenotypically Stable|A nasal wash specimen was collected at screening and on Days 7 (7-10), 12 (12-18), and 28 (28-34) post each dose and during visits for pre-specified illness symptoms occurring Day 0 through 180 days post final dose to assess vaccine virus replication. Determination of the temperature sensitivity of recovered vaccine-type virus.|Day 0 after Dose 1 to 180 days after the final dose|All nasal wash samples in which MEDI-560 was identified in the absence of wild-type HPIV3 and for which valid phenotype data are available||samples containing vaccine-like virus|Participants||Number
744299|NCT00508404|Primary|Objective Response Rate|"Objective response rate is defined as the percentage of participants with a best response of complete response or partial response. Disease assessments are based on investigator review of scans using modified Response Evaluation Criteria in Solid Tumors (RECIST) V1.0 criteria. A complete or partial response was confirmed no less than 4-weeks after the criteria for response were first met. Participants with no post-baseline assessment were considered non-responders.
Complete Response (CR): disappearance of all target and non-target lesions and no new lesions.
Partial Response (PR): At least a 30% decrease in the size of target lesions with no progression of non-target lesions and no new lesions, or, the disappearance of all target lesions but persistence of 1 or more non-target lesions not qualifying for either CR or progressive disease (PD) and no new lesions."|Tumor response was assessed at Week 8 and every 8 weeks to Week 48 and 3 monthly thereafter until disease progression; median follow-up time was 34 weeks|KRAS Tumor Response Analysis Set (all participants who provided informed consent, enrolled, received at least 1 dose of panitumumab, had evaluable KRAS status data, and with at least 1 unidimensionally measurable lesion per modified RECIST by the local investigator)||percentage of participants||95% Confidence Interval|Number
744300|NCT00508469|Primary|Adherence|Patients were considered adherent if a minimum of 80% of their instillations were administered ±2 hours of the scheduled time.|6 months|Per protocol||percentage of adherent patients|||Number
744301|NCT00508482|Secondary|Percentage of the Usage of Emergency Drugs||at the 12th week of follow-up|ITT analysis was used.||percentage of participants|||Number
744302|NCT00508482|Secondary|Percentage of the Usage of Emergency Drugs||at the 4th week of follow-up|ITT analysis was used||percentage of participants|||Number
744303|NCT00508482|Secondary|Percentage of the Usage of Emergency Drugs||over 4 weeks of treatment|ITT analysis was used.||percentage of participants|||Number
744304|NCT00508482|Secondary|Time to the First Spontaneous Bowel Movement After the First Treatment||counting by hours|ITT analysis was used||hours||Standard Deviation|Mean
744305|NCT00508482|Secondary|Change of Mean Value of Cleveland Clinic Score|Cleveland Clinic Score was assessed by doctors which contains eight items about constipation-related symptoms. Score ranges from '0' to '30'. '0' means none of symptoms and '30' means very severe symptoms. The change was calculated as the value at baseline minus the average over 4 weeks of treatment.|over 4 weeks of treatment|ITT analysis was used||units on a scale||Inter-Quartile Range|Median
744306|NCT00508482|Secondary|Change of Mean Value of Abdominal Distention|Score of abdominal distention was assessed every week according to patients' diaries during 4 weeks of treatment. Score ranges from '0' to '4'. '0' means none of symptoms and '4' means very severe symptoms. Change from baseline of the mean value of abdominal distention over 4 weeks of treatment was evaluated as the secondary outcome. The change was calculated as the value at baseline minus the average over 4 weeks of treatment. We corrected the mean value of abdominal distention by covariance because the data had significant difference among three groups at baseline.|over 4 weeks of treatment|ITT analysis was used.||units on a scale||Standard Deviation|Mean
744307|NCT00508482|Secondary|Change of Mean Value of Stool Consistency|Score of stool consistency was assessed every week according to patients' diaries during 4 weeks of treatment. Score ranges from '0' to '4'. '0' means none of symptoms and '4' means very severe symptoms. Change from baseline of the mean value of stool consistency over 4 weeks of treatment was evaluated as the secondary outcome. The change was calculated as the value at baseline minus the average over 4 weeks of treatment. We corrected the mean value of stool consistency by covariance because the data had significant difference among three groups at baseline.|over 4 weeks of treatment|ITT analysis was used.||units on a scale||Standard Deviation|Mean
744308|NCT00508482|Secondary|Change of Mean Value of Incomplete Evacuation|Score of incomplete evacuation was assessed every week according to patients' diaries during 4 weeks of treatment. Score ranges from '0' to '4'. '0' means none of symptoms and '4' means very severe symptoms. Change from baseline of the mean value of incomplete evacuation over 4 weeks of treatment was evaluated as the secondary outcome. The change was calculated as the value at baseline minus the average over 4 weeks of treatment.|over 4 weeks of treatment|ITT analysis was used.||units on a scale||Inter-Quartile Range|Median
744309|NCT00508482|Secondary|Change of Mean Value of Straining During Defecating|Score of straining during defecating was assessed every week according to patients' diaries during 4 weeks of treatment. Score ranges from '0' to '4'. '0' means none of symptoms and '4' means very severe symptoms. Change from baseline of the mean value of straining during defecating over 4 weeks of treatment was evaluated as the secondary outcome. The change was calculated as the value at baseline minus the average over 4 weeks of treatment. We corrected the mean value of straining during defecating by covariance because the data had significant difference among three groups at baseline.|over 4 weeks of treatment|ITT analysis was used||units on a scale||Standard Deviation|Mean
744310|NCT00508482|Primary|Change of Mean Weekly Spontaneous Bowel Movements|Spontaneous bowel movements per week were assessed every week during 4 weeks of treatment according to patients' diaries. Weekly spontaneous bowel movements were also assessed at the 4th and 12th week of follow-up according to patients' diaries.|over 4-week treatment, at the 4th week of follow-up, at the 12th week of follow-up|Intention-To-Treat(ITT) analysis was used.||stools/week||Inter-Quartile Range|Median
744311|NCT00508521|Primary|Fugl-Meyer Upper Limb Coordination Scale (FMUE)|A subscale of the Fugl-Meyer; the Fugl-Meyer Upper Limb Coordination Scale is a measure of movement coordination in and out of synergy patterns for the hemiparetic upper limb; scores range from 0-66, with 0 being the worst score and 66 being the best score.|baseline and after 12 weeks of training|||units on a scale||Standard Deviation|Mean
744312|NCT00508651|Secondary|Geometric Mean Titers of Serum Antibodies to HPIV3 Day 28 Post Dose 3|Post-Dose 3 GMT of HAI antibody to HPIV3|Day 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|Immunogenicity population was randomized participants who received investigational product, did not have a protocol violation that would affect interpretation of immunogenicity results, and had valid HAI results. HAI results obtained on/after detection of wild-type HPIV3 were not considered valid. A value of 2 was assigned for HAI titers < 4.||GMT||95% Confidence Interval|Mean
744313|NCT00508651|Secondary|Geometric Mean Titers of Serum Antibodies to HPIV3 Day 28 Post Dose 2|Post-Dose 2 GMT of HAI antibody to HPIV3|Day 28-34 after Dose 2 (Dose 2 was on Day 48-64)|Immunogenicity population was randomized participants who received investigational product, did not have a protocol violation that would affect interpretation of immunogenicity results, and had valid HAI results. HAI results obtained on/after detection of wild-type HPIV3 were not considered valid. A value of 2 was assigned for HAI titers < 4.||GMT||95% Confidence Interval|Mean
744317|NCT00508651|Secondary|Number of Nasal Wash Samples Containing Vaccine-like Virus in the Absence of Admixture With Wild-type HPIV3 in Which the Vaccine-like Virus Was Genotypically Stable|A nasal wash specimen was collected at screening and on Days 7 (7-10), 12 (12-18), and 28 (28-34) post each dose and during visits for pre-specified illness symptoms occurring Day 0 through 180 days post final dose to assess vaccine virus replication. Genotypic stability of recovered vaccine-type virus at the 15 mutations of phenotypic importance was assessed.|Day 0 after Dose 1 to 180 days after the final dose|All nasal wash samples in which MEDI-560 was identified in the absence of wild-type HPIV3 and for which valid genotype data are available||samples containing vaccine-like virus|Participants||Number
744318|NCT00508651|Secondary|Number of Participants With HAI Seroconversion/Seroresponse to HPIV3 28 Days After Dose 3|Hemagglutination inhibition seroconversion/seroresponse is equal to or greater than a 4-fold rise in HAI antibody titer from baseline. Hemagglutination inhibition antibody results obtained on or after detection of wild-type HPIV3 in culture were not considered valid.|Days 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|The immunogenicity population included all randomized participants who received investigational product and who did not have a major protocol violation that would affect interpretation of immune response assay results and who had valid HAI results.||participants|||Number
744319|NCT00508651|Secondary|Number of Participants With HAI Seroconversion/Seroresponse to HPIV3 28 Days After Dose 2|Hemagglutination inhibition seroconversion/seroresponse is equal to or greater than a 4-fold rise in HAI antibody titer from baseline. Hemagglutination inhibition antibody results obtained on or after detection of wild-type HPIV3 in culture were not considered valid.|Days 28-34 after Dose 2 (Dose 2 was on Day 48-64)|The immunogenicity population included all randomized participants who received investigational product and who did not have a major protocol violation that would affect interpretation of immune response assay results and who had valid HAI results.||participants|||Number
744320|NCT00508651|Secondary|Number of Participants With Hemagglutination Inhibition (HAI) Seroconversion/Seroresponse to HPIV3 28 Days After Dose 1|Hemagglutination inhibition seroconversion/seroresponse is equal to or greater than a 4-fold rise in HAI antibody titer from baseline. Hemagglutination inhibition antibody results obtained on or after detection of wild-type HPIV3 in culture were not considered valid.|Days 28-34 after Dose 1 (Dose 1 was on Day 0)|The immunogenicity population included all randomized participants who received investigational product and who did not have a major protocol violation that would affect interpretation of immune response assay results and who had valid HAI results.||participants|||Number
744321|NCT00508651|Secondary|Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 3.|Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.|Days 0-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available.||participants|||Number
744322|NCT00508651|Secondary|Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 3|Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.|Days 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available.||participants|||Number
744323|NCT00508651|Secondary|Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 3|Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.|Days 12-18 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available.||participants|||Number
744324|NCT00508651|Secondary|Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 3|Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.|Days 7-10 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available.||participants|||Number
744325|NCT00508651|Secondary|Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 2|Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.|Days 0-34 after Dose 2 (Dose 2 was on Day 48-64)|The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available.||participants|||Number
744326|NCT00508651|Secondary|Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 2|Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.|Days 28-34 after Dose 2 (Dose 2 was on Day 48-64)|The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available.||participants|||Number
744327|NCT00508651|Secondary|Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 2|Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.|Days 12-18 after Dose 2 (Dose 2 was on Day 48-64)|The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available.||participants|||Number
744328|NCT00508651|Secondary|Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 2|Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.|Days 7-10 after Dose 2 (Dose 2 was on Day 48-64)|The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available.||participants|||Number
744329|NCT00508651|Secondary|Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 1||Days 0-34 after Dose 1 (Dose 1 was on Day 0)|The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available.||participants|||Number
744330|NCT00508651|Secondary|Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 1|Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.|Days 28-34 after Dose 1 (Dose 1 was on Day 0)|The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available.||participants|||Number
744331|NCT00508651|Secondary|Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 1|Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.|Days 12-18 after Dose 1 (Dose 1 was on Day 0)|The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available.||participants|||Number
744332|NCT00508651|Secondary|Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 1|Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.|Days 7-10 after Dose 1 (Dose 1 was on Day 0)|The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available.||participants|||Number
744333|NCT00508651|Secondary|Number of Participants Shedding Vaccine-like Virus at Any Time During Study Participation|Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.|Days 7, 12, and 28 after each dose and during visits for pre-specified illness symptoms occurring Day 0 through 180 days post final dose.|The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available.||participants|||Number
744334|NCT00508651|Primary|Number of Participants With Significant New Medical Conditions (SNMCs)|A SNMC is a newly diagnosed medical condition that is of a chronic, ongoing nature and is assessed by the investigator as medically significant.|Day 0 through 180 days after final dose|Safety population was randomized participants who received investigational product and had any safety follow-up, including a temperature measurement, SE, AE, concomitant medication use, or follow-up for ≥ 1 day after dosing (ie, did not discontinue on Day 0 after receiving Dose 1).||participants|||Number
744335|NCT00508651|Primary|Number of Participants With SAEs After Dose 3||Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|Safety population for SAEs included randomized participants who received investigational product for the specified dose and had any safety follow-up after that dose (ie, did not discontinue on Day 0 after that dose)||participants|||Number
744336|NCT00508651|Primary|Number of Participants With SAEs After Dose 2|One participant had event of pneumonia after Dose 2.|Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)|Safety population for SAEs included randomized participants who received investigational product for the specified dose and had any safety follow-up after that dose (ie, did not discontinue on Day 0 after that dose)||participants|||Number
744337|NCT00508651|Primary|Number of Participants With Serious Adverse Events (SAEs) After Dose 1||Days 0-28 after Dose 1 (Dose 1 was on Day 0)|Safety population for SAEs included randomized participants who received investigational product for the specified dose and had any safety follow-up after that dose (ie, did not discontinue on Day 0 after that dose)||participant|||Number
744338|NCT00508651|Primary|Number of Participants With MA-LRIs After Dose 3||Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|Safety population for MA-LRIs included randomized participants who received investigational product for the specified dose and had any safety follow-up after that dose (ie, did not discontinue on Day 0 after that dose)||participant|||Number
744339|NCT00508651|Primary|Number of Participants With MA-LRIs After Dose 2||Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)|Safety population for MA-LRIs included randomized participants who received investigational product for the specified dose and had any safety follow-up after that dose (ie, did not discontinue on Day 0 after that dose)||participant|||Number
744340|NCT00508651|Primary|Number of Participants With Medically Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 1||Days 0-28 after Dose 1 (Dose 1 was on Day 0)|Safety population for MA-LRIs included randomized participants who received investigational product for the specified dose and had any safety follow-up after that dose (ie, did not discontinue on Day 0 after that dose)||participant|||Number
744341|NCT00508651|Primary|Number of Participants With AEs After Dose 3|Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 3.|Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|Safety population for adverse events included randomized participants who received investigational product for the specified dose and had any safety follow-up after that dose (ie, did not discontinue on Day 0 after that dose)||participants|||Number
744342|NCT00508651|Primary|Number of Participants With AEs After Dose 2|Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 2.|Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)|Safety population for adverse events included randomized participants who received investigational product for the specified dose and had any safety follow-up after that dose (ie, did not discontinue on Day 0 after that dose)||participants|||Number
744343|NCT00508651|Primary|Number of Participants With Adverse Events (AEs) After Dose 1|Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 1.|Days 0-28 after Dose 1 (Dose 1 was on Day 0)|Safety population for adverse events included randomized participants who received investigational product for the specified dose and had any safety follow-up after that dose (ie, did not discontinue on Day 0 after that dose).||participants|||Number
744344|NCT00508651|Primary|Number of Participants With SEs After Dose 3||Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|Safety population for solicited symptoms included randomized participants who received investigational product for the specified dose and had any solicited symptom data obtained after that dose.||participants|||Number
744345|NCT00508651|Primary|Number of Participants With SEs After Dose 2||Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)|Safety population for solicited symptoms included randomized participants who received investigational product for the specified dose and had any solicited symptom data obtained after that dose||participants|||Number
744346|NCT00508651|Primary|Number of Participants With Solicited Adverse Events (SEs) After Dose 1||Days 0-28 after Dose 1 (Dose 1 was on Day 0)|Safety population for solicited symptoms included randomized participants who received investigational product for the specified dose and had any solicited symptom data obtained after that dose||participants|||Number
744347|NCT00508716|Primary|Re-hospitalization or Death|Number of participants who are re-hospitalized or die within 90 days of discharge|90 days|||participants|||Number
744367|NCT00509028|Secondary|Number of Patients With Abnormal Plasma Cortisol Values.|Cut-off value of cortisol is defined as 4 mcg/dL.|54 weeks|||Participants|||Number
744368|NCT00509028|Secondary|Number of Patients With Abnormal Vital Sign Values for the Following Variables: Blood Pressure (Sitting) and Pulse Rate (Sitting), as Judged by the Investigator||54 weeks|||Participants|||Number
744348|NCT00508742|Secondary|Percentage of Participants With Nasopharyngeal Cultures Testing Positive for 6A' (6A + 6C) or 19A Serotypes of Streptococcus Pneumoniae (S. Pneumoniae) at 7, 12, 13, 18 and 24 Months of Age||Month 7, 12, 13, 18, 24|Evaluable culture population; 'n' is number of participants with at least 1 determinate nasopharyngeal culture result for given serotype combination at specified time points for each arm group respectively.||percentage of participants||95% Confidence Interval|Number
744349|NCT00508742|Primary|Percentage of Participants With a New Acquisition of Serotype 6A' (6A + 6C) or 19A Combined 1 Month After the Infant Series to 24 Months of Age|A new acquisition was defined as the detection of a serotype (here 6A’ [6A + 6C] or 19A), once a participant was fully vaccinated (one month after dose 3), that had not been detected previously in the baseline samples at 2, 4, 6 months of age.|Month 7 through Month 24|Evaluable culture population included all participants who adhered to protocol requirements; received the treatment to which they were randomized; had at least 1 nasopharyngeal swab for the proposed analysis and no major protocol violations.||percentage of participants||95% Confidence Interval|Number
744350|NCT00508755|Primary|Observational Gait Components: Observational Comparison of Gait Components for: Gait Robot-alone Condition, FES-alone Condition, and Combined Gait Robot and FES.|Observational Gait components during stance and swing phase, for pelvis, hip, knee, and ankle for each of the six participants was observed during the following conditions: Gait Robot-alone, FES-alone, and combined Gait Robot and FES.|visit 48, following treatment|The sample size for this feasibility study was n=6, constrained by funding limit.||participants|||Number
744351|NCT00508820|Secondary|Platelet Response (Definition 2)|Platelet response using definition 2 (a platelet count increase of >=20 x 109/L from baseline)|Duration of treatment (up to 201 weeks)|Full Analysis Set, all enrolled participants||Participants|||Number
744352|NCT00508820|Secondary|Platelet Response (Definition 1)|Platelet response using definition1 . (a doubling of baseline platelet count and a platelet count of >=50 x 10^9/L|Duration of treatment (up to 201 weeks)|Full Analysis Set, all enrolled participants||Participants|||Number
744353|NCT00508820|Primary|Adverse Events|One or more occurences of one or more adverse events within the participant during the study. Participants with more than one event were only counted once|Duration of Treatment plus 30 days or End of Study (whichever is later). Approximately 205 weeks.|Safety Analysis Set, comprised of all participants who received at least one dose of romiplostim||participants|||Number
744354|NCT00508872|Primary|Complete Gross Resection Rate|Complete gross resection rate for patients with initially unresectable hepatic colorectal metastasis who are treated with a combination of oxaliplatin/ 5-fluorouracil/ leucovorin/ bevacizumab (Number of Resectable versus Not Resectable Patients).|Over 4 year study period|Intended analysis was per protocol. Study terminated early, leading to only two (2) patients recruited, one not eligible for study and second inevaluable.|||||
744355|NCT00508924|Primary|Composite and Each of Death, Myocardial Infarction, and Urgent Revascularisation at Day 30, and Major Bleeding Events During Hospital Stay.|"Composite end point (a): all cause death, myocardial infarction and urgent revascularization at Day30
Composite end point (b): all cause death, myocardial infarction and urgent revascularization at Day30 as well as major bleeding events during hospital stay"|30 Days|||participants|||Number
744356|NCT00508924|Primary|Activated Clotting Time (ACT) Value After the First Dosing of Study Treatment.||5 - 10 min after initial bolus|||second||Inter-Quartile Range|Median
744357|NCT00509028|Secondary|Forced Expiratory Volume in One Second (FEV1) Percentage of Predicted Normal Change From Baseline|Forced Expiratory Volume in one second (FEV1) percentage of predicted normal change from baseline calculated as: 100 * (FEV1 at last visit - FEV1 at randomization)/predicted normal FEV1).|54 weeks|||Percentage||Standard Deviation|Mean
744358|NCT00509028|Secondary|Change From Baseline in Disturbance of Night-time Sleep|"Change in disturbance of night-time sleep from baseline calculated as (disturbances of night-time sleep at last visit - disturbances of night-time sleep at randomization).
Frequency of disturbance of night- time sleep was assessed using 3- grade scale (normal, almost able, unable)."|Baseline and 54 weeks|||Disturbances per night||Standard Deviation|Mean
744359|NCT00509028|Secondary|Change From Baseline in Disturbance of Daily Activities|"Change in disturbance of daily activities from baseline calculated as (disturbance of daily activities at last visit - disturbance of daily activities at randomization).
Frequency of disturbance of daily activity was assessed using 3- grade scale (normal, almost able, unable)."|Baseline and 54 weeks|||Disturbances per day||Standard Deviation|Mean
744360|NCT00509028|Secondary|Change From Baseline of Use of Inhaled Short-acting B-2 Agonist (Night-time)|Change in use of inhaled short-acting B-2 agonist (night-time) from baseline calculated as (use of inhaled short-acting B-2 agonist (night-time) at last visit - use of inhaled short-acting B-2 agonist (night-time) at randomization)|Baseline and 54 weeks|||Puffs per day||Standard Deviation|Mean
744361|NCT00509028|Secondary|Change From Baseline of Use of Inhaled Short-acting B-2 Agonist (Daytime)|Change in use of inhaled short-acting B-2 agonist (daytime) from baseline calculated as (use of inhaled short-acting B-2 agonist (daytime) at last visit - use of inhaled short-acting B-2 agonist (daytime) at randomization)|Baseline and 54 weeks|||Puffs per day||Standard Deviation|Mean
744362|NCT00509028|Secondary|Change From Baseline of Respiratory Condition at Asthma Attacks (Nighttime)|"Change in respiratory condition at asthma attacks (nighttime) from baseline calculated as (respiratory condition at asthma attacks (nighttime) at last visit - respiratory condition at asthma attacks (night-time) at randomization).
Scale: 0 - 4. 0 = None. 1 = Mild. 2 = Moderate. 3= Severe. 4 = Respiratory insufficiency."|Baseline and 54 weeks|||Points on a scale||Standard Deviation|Mean
744363|NCT00509028|Secondary|Change From Baseline of Respiratory Condition at Asthma Attacks (Daytime)|"Change in respiratory condition at asthma attacks (daytime) from baseline to last visit. Scale: 0 - 4.
0 = None. 1 = Mild. 2 = Moderate. 3= Severe. 4 = Respiratory insufficiency"|Baseline and 54 weeks|||Points on a scale||Standard Deviation|Mean
744364|NCT00509028|Secondary|Morning Peak Expiratory Flow (PEF) Percentage of Predicted Normal|Change in PEF percent of predicted normal calculated as (PEF percent predicted normal at last visit - PEF percent predicted normal at randomization).|54 weeks|||Percentage||Standard Deviation|Mean
744365|NCT00509028|Secondary|Weight|Weight, change from baseline calculated as (weight at last visit - weight at randomization)|Baseline and 54 weeks|||kilograms||Standard Deviation|Mean
744366|NCT00509028|Secondary|Height|Height, change from baseline calculated as (height at last visit - height at randomization)|Baseline and 54 weeks|||Centimeters||Standard Deviation|Mean
744369|NCT00509028|Secondary|Number of Patients With Abnormal Clinical Laboratory Test Values.|"Analysis of haematological, clinical chemistry and urynalysis variables were performed.
Haematology variables: erythrocytes, haemoglobin, haematocrit, leucocyte count, leucocyte different count (neutrophils, eosinophils, basophils, lymphocytes, monocytes), platelet count.
Clinical chemistry measurements: aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), total bilirubin, albumin, creatinine,sodium, potassium, total protein, blood urea nitrogen.
Urinalysis variables: protein, glucose, urobilinogen, occult."|54 weeks|||Participants|||Number
744370|NCT00509028|Primary|Number of Patients With Adverse Events (AEs).|AEs were defined as undesirable medical conditions or deteriorations of a pre-existing medical condition following/during exposure. All Serious AEs, AEs leading to withdrawal, Other relevant AE were recorded.|54 weeks|||Participants|||Number
744371|NCT00509041|Secondary|Progression Free Survival|Progression free survival (PFS) was defined as the time from registration to progression or death of any cause. Progression free and alive patients were censored at the date of last follow-up. The median PFS with 95% CI was estimated using the Kaplan Meier method.|Time from registration to progression or death (up to 3 years)|||weeks||95% Confidence Interval|Median
744372|NCT00509041|Secondary|Overall Survival|Overall survival (OS) was defined as the time from registration to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% CI was estimated using the Kaplan Meier method.|Time from registration to death (up to 3 years)|||weeks||95% Confidence Interval|Median
744373|NCT00509041|Secondary|Number of Participants With Overall Tumor Response|"Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria:
Complete Response (CR): disappearance of all target lesions;
Partial Response (PR) 30% decrease in sum of longest diameter of target lesions;
Progressive Disease (PD): 20% increase in sum of longest diameter of target lesions;
Stable Disease (SD): small changes that do not meet above criteria.
Overall tumor response is the total number of CR and PRs."|Duration of study until progression (up to 3 years)|||participants|||Number
744374|NCT00509041|Primary|24 Week Progression Free Survival|Percentage of participants who were alive and progression free at 24 weeks. The 24 week progression free survival, with 95% confidence interval, was estimated using the Kaplan Meier method.|24 weeks|||percentage of participants||95% Confidence Interval|Number
744375|NCT00509067|Secondary|Electrocardiogram||Measured at pre- and post-intervention||||||
744376|NCT00509067|Secondary|Nicotine Use||Measured at Baseline and Weeks 4, 8, 12, and 16||||||
744377|NCT00509067|Secondary|Cognitive Measures (MATRICS: Attention, Memory, Processing Speed)||Measured at Baseline and Weeks 8 and 16||||||
744378|NCT00509067|Secondary|Clinical Global Impression||Measured at Baseline and Weeks 4, 8, 12, and 16||||||
744379|NCT00509067|Primary|Negative Symptoms Measured on Positive and Negative Syndrome Scale (PANSS)|The score for each subject was the sum of the ratings for five items on the negative-symptom subscale of the PANSS: 1) blunted affect, 2) emotional withdrawal, 3) poor rapport, 4) passive/apathetic social withdrawal, and 5) lack of spontaneity and flow of conversation. Each item (symptom) is rated on a scale from 1 = absence of negative symptom to 7 = extreme negative symptom. The sum of the ratings for the five items range from 5 to 35, with higher scores indicating more severe symptoms. The primary outcome measure is the mean of the sum of these ratings across subjects.|Measured at Baseline and Weeks 4, 8, 12, and 16|intent to treat||units on a scale||Standard Deviation|Mean
744380|NCT00509106|Secondary|Evaluate Safety||first dose, throughout the treatment period, and up to the TOC visit||||||
744381|NCT00509106|Secondary|Microbiological Reinfection/Recurrence at LFU||21 to 35 days after last dose of study drug||||||
744382|NCT00509106|Secondary|Clinical Relapse at Late Follow Up (LFU) Visit||21-35 days after last dose of study drug||||||
744383|NCT00509106|Secondary|Clinical and Microbiological Response by Pathogen at TOC||8-15 days after last dose of study drug||||||
744384|NCT00509106|Secondary|Overall Clinical and Radiographic Success Rate at TOC||8-15 days after last dose of study drug||||||
744385|NCT00509106|Secondary|Microbiological Success Rate at TOC||8-15 days after last dose of study drug||||||
744386|NCT00509106|Secondary|Clinical Response at End of Therapy (EOT)||Last day of study drug administration||||||
744387|NCT00509106|Primary|Clinical Cure Rate for Ceftaroline Compared With That for Ceftriaxone at TOC in the Clinically Evaluable (CE) Population||8-15 days after last dose of study drug||||||
744388|NCT00509106|Primary|Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at the Test of Cure (TOC) in the Modified Intent to Treat Efficacy (MITTE) Population|"Cure:Total resolution of all signs and symptoms of pneumonia (ie,CABP), or improvement to such an extent that further antimicrobial therapy was not necessary
Failure: Any of the following:
Persistence, incomplete clinical resolution, or worsening in signs and symptoms of CABP that required alternative antimicrobial therapy
Treatment-limiting adverse event (AE) leading to discontinuation of study drug therapy, when subject required alternative antimicrobial therapy to treat the pneumonia
Death wherein pneumonia (ie,CABP) was considered causative
Indeterminate: Inability to determine an outcome"|8-15 days after last dose of study drug|The MITTE Population consisted of all subjects in the MITT Population (all randomized subjects who received any amount of the study drug) in PORT Risk Class III or IV. The Pneumonia Outcomes Research Team (PORT) scale of CAP severity in which Risk Class I is associated with the lowest risk for mortality and Risk Class V represents the highest risk.||participants|||Number
744389|NCT00509197|Secondary|Change in Provocative Concentration of Methacholine Inducing a 20% Fall in FEV1 (PC20)|Change in provocative concentration of methacholine inducing a 20% fall in FEV1 (PC20) after fluticasone or placebo treatment|Four weeks|||mg/ml||Standard Deviation|Mean
744390|NCT00509197|Secondary|Change in Forced Expiratory Volume in One Second (FEV1)|Change in forced expiratory volume in one second (FEV1) after fluticasone or placebo treatment.|Four weeks|||L||Standard Deviation|Mean
744406|NCT00509366|Secondary|Drug Sensitivity Quartiles for Cisplatin and Pemetrexed|Using genomics-based prediction models previously developed separately for cisplatin and pemetrexed, the probability that each patient was sensitive or would respond to treatment was computed. Quartiles describe the patterns of drug sensitivity probabilities. The 1st, 2nd, and 3rd quartiles are the sensitivity levels at which 25%, 50%, and 75% of patients have lower sensitivity.|3 years|This outcome is not summarized due to irreproducibility of the genomics-based prediction model and resulting probability estimates.|||||
744391|NCT00509197|Secondary|Asthma Quality of Life Questionnaire (AQLQ) Score After 4 Weeks of Treatment|Validated questionnaire assessing quality of life related to asthma after 4 weeks of treatment. The AQLQ is composed of 32 questions in 4 domains (symptoms, activity limitation, emotional function and environmental stimuli). The activity domain contains 5 ‘patient-specific’ questions. This allows patients to select 5 activities in which they are most limited and these activities will be assessed at each follow-up. Patients are asked to think about how they have been during the previous two weeks and to respond to each of the 32 questions on a 7-point scale (7 = not impaired at all - 1 = severely impaired). The AQLQ score is rated on a 7-point scale (1=maximal impairment, 7=no impairment) to yield a mean score out of 7. The worse the quality of life is , the lower the score is.|Four weeks|||units on a scale||Standard Deviation|Mean
744392|NCT00509197|Primary|Asthma Control Questionnaire (ACQ) Score After 4 Weeks of Treatment With Inhaled Corticosteroids (ICS) or Placebo|Validated questionnaire assessing asthma control after 4 weeks of treatment with ICS or placebo. The ACQ has 7 questions (the top scoring 5 symptoms, FEV1% pred. and daily rescue bronchodilator use). Patients are asked to recall how their asthma has been during the previous week and to respond to the symptom and bronchodilator use questions on a 7-point scale (0=no impairment, 6= maximum impairment). The ACQ score is the mean of 7 items and thus ranges between 0 (well controlled) and 6 (extremely poorly controlled) to yield a mean score out of 6. The higher the score, the worst asthma control is.|Four weeks|Intention to treat||units on a scale||Standard Deviation|Mean
744393|NCT00509223|Primary|HbA1c Change|Month 6 change in HbA1c (%)|Baseline to Month 6|The following definition was applied to the primary endpoint: included in analysis were all participants that had at least 1 follow-up HbA1c value in addition to the Baseline HbA1c were considered.||HbA1c percent||Standard Deviation|Mean
744394|NCT00509236|Secondary|Change From Baseline in Hemoglobin A1c for Sitagliptin Versus Glipizide Treatment|Change from baseline in least square means hemoglobin A1c after treatment with sitagliptin versus glipizide for 54 weeks. Hemoglobin A1c is the percent of hemoglobin that is glycated.|Baseline / Week 54|Randomized participants. Numbers analyzed excluded participants with either no baseline or no post-baseline measurements. The last observation carried forward (LOCF) method was used to impute missing values.||Percent hemoglobin A1c||95% Confidence Interval|Least Squares Mean
744395|NCT00509236|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|Change from baseline in mean Fasting Plasma Glucose after treatment with sitagliptin versus glipizide for 54 weeks.|Baseline / Week 54|Randomized participants. Numbers analyzed excluded participants with no baseline or no post-baseline measurements. The last observation carried forward (LOCF) method was used to impute missing values.||mg/dL||Standard Deviation|Mean
744396|NCT00509236|Primary|Number of Participants With Clinical Adverse Events|Reported experiences assessed by investigators as adverse events, excluding data after initiation of glycemic rescue therapy.|54 Week Treatment Period + 28 days|All randomized participants.||Participants|||Number
744397|NCT00509236|Secondary|Number of Participants With Symptomatic Hypoglycemic Adverse Events|A symptomatic hypoglycemic adverse event is an episode with clinical symptoms attributed to hypoglycemia, without regard to fingerstick glucose level.|54 Week Treatment Period + 28 days|All randomized participants.||Participants|||Number
744398|NCT00509236|Primary|Change From Baseline in Hemoglobin A1c After Sitagliptin Treatment|Change from baseline in mean hemoglobin A1c after treatment with sitagliptin for 54 weeks. Hemoglobin A1c is the percent of hemoglobin that is glycated. Results for the glipizide arm are not reported in this table because the primary outcome measure is for the sitagliptin arm only.|Baseline / Week 54|Randomized participants. Numbers analyzed excluded participants with either no baseline or no post-baseline measurements. The last observation carried forward (LOCF) method was used to impute missing values.||Percent hemoglobin A1c||Standard Deviation|Mean
744399|NCT00509249|Primary|Hematological Response Rate|Complete Response (CR): repeat bone marrow (BM) shows <5% myeloblasts, and peripheral blood values lasting ≥ 2 months of hemoglobin (hgb) (>110 g/L), neutrophils (≥1.0x10^9/L), platelets (≥100x10^9/L), blasts (0%) and no dysplasia. Partial Response (PR): same as CR for peripheral blood except BM shows blasts decrease by ≥ 50% but still > 5% or a less advanced FAB classification from pretreatment. Hematological response=CR+PR.|Up to 3 years|||participants|||Number
744400|NCT00509262|Secondary|Change From Baseline in Body Weight at Week 54||Baseline to Week 54|All participants as treated (APaT) population included participants who had both baseline and Week 54 data (excluding data after initiation of glycemic rescue therapy).||kg||Standard Error|Least Squares Mean
744401|NCT00509262|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 54||Baseline to Week 54|The per protocol population required that a participant had measurements both at baseline and at Week 54, and did not have any major protocol violations (e.g. drug compliance <75%, addition of prohibited antihyperglycemic agent, or incorrect double-blind study medication). No missing data were imputed.||mg/dL||Standard Deviation|Mean
744402|NCT00509262|Primary|Percentage of Participants With Hypoglycemic Events|Percentage of participants with at least one symptomatic hypoglycemic adverse event, excluding data after initiation of glycemic rescue therapy.|Baseline up to 28 days following the last dose of study therapy|All participants as treated (APaT) population included all randomized participants who took at least one dose of study therapy.||percentage of participants|||Number
744403|NCT00509262|Primary|Change From Baseline in Hemoglobin A1c (A1C) Levels at Week 54|A1C represents percentage of glycosylated hemoglobin.|Baseline to Week 54|The per protocol population required that a participant had measurements both at baseline and at Week 54, and did not have any major protocol violations (e.g. drug compliance <75%, addition of prohibited antihyperglycemic agent, or incorrect double-blind study medication). No missing data were imputed.||Percent of glycosylated hemoglobin||Standard Deviation|Mean
744404|NCT00509288|Secondary|Toxicity|Here is the number of participants with adverse events. For a detailed listing of adverse events, see the adverse event module.|57 months|||Participants|||Number
744405|NCT00509288|Primary|Clinical Tumor Regression.|Tumor regression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.|7/5/07-4/23/09|||Participants|||Number
744407|NCT00509366|Secondary|Mean Change From Baseline to Follow-up Cycle in Quality of Life - Functional Assessment of Cancer Therapy-Lung (FACT-L)|The outcome measure is mean change in the Trial Outcome Index (TOI) between baseline and each follow-up assessment measured by the Functional Assessment of Cancer Therapy-Lung (FACT-L). The FACT-L instrument consists of 34 items to assess physical (PWB), social and family (SWB), emotional (EWB), functional well-being (FWB) and additional lung specific concerns (LCS). Using a 5-point Likert type scale, responses to individual items range from 0 (not at all) to 4 (Very Much) with higher scores indicating better quality of life. The TOI is the sum of PWB (7 items), FWB (7 items) and LCS scores (7 items), which each have a possible range between 0 and 28. Therefore, TOI ranges from 0 to 84.|Baseline, Every 21 days for a maximum of 6 cycles|Of the 50 patients assigned treatment, only 32 patients completed the FACT-L assessment at baseline and at least one follow-up.||units on a scale||Standard Error|Mean
744408|NCT00509366|Secondary|Median Time to Progressive Disease|Median time to progressive disease was defined as the time from enrollment to the the time at which 50% of patients had experienced disease progression. Enrollment is defined as having successful genomic analysis and start of chemotherapy. Time was censored at date of death for patients who have not had documented disease progression, at first available date of other anti-tumor therapy for patients who were either administered other anti-tumor therapy prior to documented disease progression or administered other anti-tumor therapy without documented disease progression, and at last date of followup if neither non-protocol therapy was administered nor progression documented.|1 Year|Due to the irreproducible nature of the genomic signatures of cisplatin sensitivity, analyses based on separate treatment groups were inappropriate. Therefore, all enrolled participants (initiated for treatment) from both treatment arms were analyzed together.||months||95% Confidence Interval|Number
744409|NCT00509366|Primary|1-year Progression Free Survival Rate in Chemo-naive Select Stage IIIB or Stage IV NSCLC Patients|One-year progression-free survival was defined from the time from initiation of study treatment to the first date of disease progression or death as a result of any cause. Progression was defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Time was censored at the date of the last follow-up visit for patients who were still alive and have not progressed. The one-year progression free survival rate is a percentage, representing the fraction of treated patients who, after one-year, are disease free or alive.|1 year|Due to the irreproducible nature of the genomic signatures of cisplatin sensitivity, analyses based on separate treatment groups were inappropriate. Therefore, all enrolled participants (initiated for treatment) from both treatment arms were analyzed together.||percentage of treated patients||95% Confidence Interval|Number
744410|NCT00509392|Secondary|Change in CIVIQ QOL|"Chronic Venous Insufficiency Questionnaire(CIVIQ) for Quality of Life(QOL). (Min 20- Max 100).
Global index and an outline of 4 quality-of-life dimensions: pain (4 items), physical (4 items), psychological (9 items), and social (3 items). A low global (total) score corresponds to greater patient comfort.
Change from Baseline"|1 Month|Data at 1 month follow-up visit||units on a scale|limbs|Standard Deviation|Mean
744411|NCT00509392|Secondary|Change in CIVIQ QOL|"Chronic Venous Insufficiency Questionnaire(CIVIQ) for Quality of Life(QOL) (Min 20- Max 100).
Global index and an outline of 4 quality-of-life dimensions: pain (4 items), physical (4 items), psychological (9 items), and social (3 items). A low global (total) score corresponds to greater patient comfort.
Change from Baseline"|2 Week|Data at 2-week follow up visit||units on a scale|limbs|Standard Deviation|Mean
744412|NCT00509392|Secondary|Change in CIVIQ QOL|"Chronic Venous Insufficiency Questionnaire(CIVIQ) for Quality of Life(QOL). (Min 20- Max 100).
Global index and an outline of 4 quality-of-life dimensions: pain (4 items), physical (4 items), psychological (9 items), and social (3 items). A low global (total) score corresponds to greater patient comfort.
Change from Baseline"|1 Week|Data at one week follow up visit||units on a scale|limbs|Standard Deviation|Mean
744413|NCT00509392|Secondary|Change in CIVIQ QOL|"Chronic Venous Insufficiency Questionnaire(CIVIQ) for Quality of Life(QOL). (Min 20- Max 100).
Global index and an outline of 4 quality-of-life dimensions: pain (4 items), physical (4 items), psychological (9 items), and social (3 items). A low global (total) score corresponds to greater patient comfort.
Change from Baseline"|48 Hours|Data at 48 hrs follow up visit||units on a scale|limbs|Standard Deviation|Mean
744414|NCT00509392|Secondary|VCSS|"Venous Clinical Severity Score (0-30 total overall score):
0(minimum)- No evidence of venous disease 30(maximum)- Severe venous disease"|1 Month|Data at 1- month follow up visit||units on a scale|limbs|Standard Deviation|Mean
744415|NCT00509392|Secondary|VCSS|"Venous Clinical Severity Score (0-30 total overall score):
0(minimum)- No evidence of venous disease 30(maximum)- Severe venous disease"|2 Weeks|Data at 2 week follow up visit||units on a scale|limbs|Standard Deviation|Mean
744416|NCT00509392|Secondary|VCSS|"Venous Clinical Severity Score (0-30 total overall score):
0(minimum)- No evidence of venous disease 30(maximum)- Severe venous disease"|1 Week|Data at 1-week follow up visit||units on a scale|limbs|Standard Deviation|Mean
744417|NCT00509392|Secondary|VCSS|"Venous Clinical Severity Score (0-30 total overall score):
0(minimum)- No evidence of venous disease 30(maximum)- Severe venous disease"|48 Hours|Data at 48 hours for follow up visit||units on a scale|limbs|Standard Deviation|Mean
744418|NCT00509392|Primary|Complications|Sequelae at any follow-up|1 month|Data up to one month follow up visit||limbs|limbs||Count of Units
744419|NCT00509392|Primary|Ecchymosis|"0-5 scale (5 most severe) 0: None
<25%
25-50%
50-75%
75-100%
Above or below tx segment"|1 Month post treatment (no baseline)|Data available at 1- month follow-up visit||limbs|limbs||Number
744420|NCT00509392|Primary|Ecchymosis|"0-5 scale (5 most severe) 0: None
<25%
25-50%
50-75%
75-100%
Above or below tx segment"|2 Weeks post treatment (no baseline)|Intent to treat/ SP: Data available at 2-week follow-up visit||limbs|limbs||Number
744421|NCT00509392|Primary|Ecchymosis|"0-5 scale (5 most severe) 0: None
<25%
25-50%
50-75%
75-100%
Above or below tx segment"|1 Week post treatment (no baseline)|Data available at 1-week follow-up visit||limbs|limbs||Number
744422|NCT00509392|Primary|Ecchymosis|"0-5 scale (5 most severe) 0: None
<25%
25-50%
50-75%
75-100%
Above or below treated (tx) segment"|48 Hours post treatment (no baseline)|Data available at 48hrs follow-up visit||limbs|limbs||Number
744423|NCT00509392|Primary|Tenderness|Tenderness 0-10 scale (10 most severe)|1 Month|Data available at 1 month follow-up visit||units on a scale|limbs|Standard Deviation|Mean
744432|NCT00509496|Primary|Clinical Tumor Regression.|Clinical tumor regression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is a disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD)is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.|20 months|||Participants|||Number
744433|NCT00509587|Secondary|Adverse Events Graded According to the NCI CTCAE Version 3.0|grade 3– 4 toxicities - transaminitis, hypertension, and neutropenia in three patients each (14% each) and grade 3 gastrointestinal hemorrhage in one patient (5%).|Up to 3 years|||percentage of patients|||Number
744434|NCT00509587|Secondary|Overall Survival|Computed using the Kaplan-Meier method.|Up to 3 years|||months||95% Confidence Interval|Median
744435|NCT00509587|Secondary|Progression-free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a nontarget lesion, or the appearance of new lesions|6 months|||percentage of patients||95% Confidence Interval|Number
744436|NCT00509587|Secondary|Duration of Stable Disease||From the start of the treatment until the criteria for progression are met, assessed up to 3 years|||months||95% Confidence Interval|Median
744437|NCT00509587|Secondary|Duration of Objective Response||From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 3 years||||||
744438|NCT00509587|Primary|Number of Participants With Partial and Complete Response.|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT / MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Up to 3 years|||participant|||Number
744439|NCT00509600|Primary|Patient Response|Response is defined as a WBC < 15,000 and platelets > 75,000 at 12 weeks; toxicity is defined as a grade 3 or worse infection or non-hematologic toxicity within the first 4 weeks.|12 weeks|No analysis as only registrant inevaluable, and trial terminated early due to poor enrollment.|||||
744440|NCT00509769|Secondary|Progression-free Survival Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)|Progression-free survival (PFS) was defined as the time from the first day of study treatment to documented disease progression or death on study (ie, death from any cause within 30 days of the last dose of study drug), whichever occurred first. Disease progression was at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. For patients who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate PFS.|Randomization until the final analysis cut-off date of 25 Jun 2009 (end of the study, approximately 12 months after the last patient was enrolled, up to 23 months)|Efficacy evaluable population: All patients who received at least 1 dose of study drug and who underwent a baseline and at least 1 post-baseline tumor assessment or died while in the study from any cause within 30 days of the last dose of study drug.||Months||95% Confidence Interval|Median
744441|NCT00509769|Secondary|Duration of Objective Response Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)|For patients who achieved an objective response, duration of objective response was defined as the time from the first tumor assessment that supported a patient's objective response to the time of disease progression or death on study (ie, death from any cause within 30 days of the last dose of study drug), whichever occurred first. Disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of 1 or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. For participants who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate the duration of objective response.|Randomization until the final analysis cut-off date of 25 Jun 2009 (end of the study, approximately 12 months after the last patient was enrolled, up to 23 months)|Patients who had an objective response in the efficacy evaluable population: All patients who received at least 1 dose of study drug and who underwent a baseline and at least 1 post-baseline tumor assessment or died while in the study from any cause within 30 days of the last dose of study drug.||Months||95% Confidence Interval|Median
744442|NCT00509769|Secondary|Objective Response Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)|Objective response was defined as a complete response (CR) or partial response (PR) determined on 2 consecutive occasions ≥ 4 weeks apart, using Response Evaluation Criteria in Solid Tumors (RECIST). CR: The disappearance of all target lesions and all non-target lesions, normalization of tumor marker level, and no new lesions. PR: Disappearance of all target lesions and persistence of ≥ 1 non-target lesions and/or the maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of the longest diameter of target lesions, and no new lesions or unequivocal progression of existing non-target lesions.|Randomization until the final analysis cut-off date of 25 Jun 2009 (end of the study, approximately 12 months after the last patient was enrolled, up to 23 months)|Efficacy evaluable population: All patients who received at least 1 dose of study drug and who underwent a baseline and at least 1 post-baseline tumor assessment or died while in the study from any cause within 30 days of the last dose of study drug.||Percentage of patients||95% Confidence Interval|Number
744455|NCT00502242|Secondary|Percentage of Participants With Hyperkalemia|Hyperkalemia defined as serum potassium >5.6 millimoles per liter (mmol/L)|Baseline, Pre-SRL (from first dose of ramipril/placebo up to SRL conversion), On-Therapy (up to 52 weeks after SRL conversion), and Off-Therapy Period (up to 56 weeks after SRL conversion)|Safety population; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
747608|NCT00530842|Secondary|Static Lung Volumes|Trough TGV(FRC) (Thoracic Gas Volume) after 4 weeks (measured by bodyphlethysmography)|4 weeks|FAS using imputed values||Litres||Standard Error|Mean
744443|NCT00509769|Secondary|Progression-free Survival (PFS) Assessed by the Independent Review Facility Using Response Evaluation Criteria in Solid Tumors (RECIST)|Progression-free survival (PFS) was defined as the time from the first day of study treatment to documented disease progression or death on study (ie, death from any cause within 30 days of the last dose of study drug), whichever occurred first. Disease progression was at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. For patients who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate PFS.|Randomization until the final analysis cut-off date of 25 Jun 2009 (end of the study, approximately 12 months after the last patient was enrolled, up to 23 months)|Efficacy evaluable population: All patients who received at least 1 dose of study drug and who underwent a baseline and at least 1 post-baseline tumor assessment or died while in the study from any cause within 30 days of the last dose of study drug.||Months||95% Confidence Interval|Median
744444|NCT00509769|Secondary|Duration of Objective Response (OR) Assessed by the Independent Review Facility Using Response Evaluation Criteria in Solid Tumors (RECIST)|For patients who achieved an objective response, duration of objective response was defined as the time from the first tumor assessment that supported a patient's objective response to the time of disease progression or death on study (ie, death from any cause within 30 days of the last dose of study drug), whichever occurred first. Disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of 1 or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. For participants who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate the duration of objective response.|Randomization until the final analysis cut-off date of 25 Jun 2009 (end of the study, approximately 12 months after the last patient was enrolled, up to 23 months)|Patients who had an objective response in the efficacy evaluable population: All patients who received at least 1 dose of study drug and who underwent a baseline and at least 1 post-baseline tumor assessment or died while in the study from any cause within 30 days of the last dose of study drug.||Months||95% Confidence Interval|Median
744445|NCT00509769|Primary|Objective Response Assessed by the Independent Review Facility Using Response Evaluation Criteria in Solid Tumors (RECIST)|Objective response was defined as a complete response (CR) or partial response (PR) determined on 2 consecutive occasions ≥ 4 weeks apart, using Response Evaluation Criteria in Solid Tumors (RECIST). CR: The disappearance of all target lesions and all non-target lesions, normalization of tumor marker level, and no new lesions. PR: Disappearance of all target lesions and persistence of ≥ 1 non-target lesions and/or the maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of the longest diameter of target lesions, and no new lesions or unequivocal progression of existing non-target lesions.|Randomization until the analysis data cutoff-dates of 31 Jan 2009 (6 months after the last patient was enrolled in the study) and 25 Jun 2009 (approximately 12 months after the last patient was enrolled in the study, up to 23 months)|Efficacy evaluable population: All patients who received at least 1 dose of study drug and who underwent a baseline and at least 1 post-baseline tumor assessment or died while in the study from any cause within 30 days of the last dose of study drug.||Percentage of patients||95% Confidence Interval|Number
744446|NCT00509795|Secondary|Mean Change From Baseline in Choroidal Neovascularization (CNV) Area at Week 52 (LOCF)|CNV area values measured in square millimeters (mm^2); lower values represent better outcomes.|Baseline and at week 52|FAS population used for analysis.||mm^2||Standard Deviation|Mean
744447|NCT00509795|Secondary|Mean Change From Baseline in National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25) Total Score at Week 52 - LOCF|The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales which are all scored from 0-100. To reach the overall composite score, each sub-scale score is averaged in order to give each sub-scale equal weight.|Baseline and at Week 52|FAS population used for analysis.||scores on a scale||Standard Deviation|Mean
744448|NCT00509795|Secondary|Percentage of Patients Who Gained at Least 15 Letters of Vision in the ETDRS Letter Score in the Study Eye at Week 52 - LOCF.|Defined study baseline range of ETDRS Best Corrected Visual Acuity of: letter score of 73 to 25 (20/40 to 20/320) in the study eye; a higher score represents better functioning.|Baseline and at week 52|FAS population used for analysis.||percentage of patients|||Number
744449|NCT00509795|Secondary|Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 52 - LOCF|Defined study baseline range of ETDRS Best Corrected Visual Acuity of: letter score of 73 to 25 (20/40 to 20/320) in the study eye; a higher score represents better functioning.|Baseline and at week 52|FAS population used for analysis.||letters read||Standard Deviation|Mean
744450|NCT00509795|Primary|Percentage of Patients Who Maintained Vision at Week 52 - Last Observation Carried Forward (LOCF)|Defined “maintenance of vision” as patients who lost fewer than 15 letters in Early Treatment Diabetic Retinopathy Study (ETDRS) letter score compared to baseline.|Baseline and at week 52|PPS population used for analysis.||percentage of patients|||Number
744451|NCT00502203|Primary|Number of Participants With Overall Response|Overall response rate including complete (CR) and partial responses (PR) with measurable disease using Response Evaluation Criteria In Solid Tumors (RECIST) assessment. CR: Disappearance of all target and non-target lesions; no evidence of new lesions documented by 2 disease assessments at least 4 weeks apart. PR: At least 30% decrease in sum of longest dimensions (LD) of all target measurable lesions reference baseline sum of LD; no unequivocal progression of non-target lesions and no new lesions. Documentation by 2 disease assessments at least 4 weeks apart is required.|24 Months|Thirteen participants had measurable disease therefore evaluable for a complete or partial response.||participants|||Number
744452|NCT00502216|Secondary|Tolerability of the Combination of 25 mg Naltrexone and 2 mg Varenicline||11 weeks||||||
744453|NCT00502216|Secondary|Weight Gain in Participants Who Are Continuously Abstinent for the Last 4 Weeks of Treatment||4 weeks||||||
744454|NCT00502216|Primary|Weight Gain in Treatment Completers||baseline and 12 weeks|Subpopulation of participants who reported quitting smoking||Pounds||Standard Deviation|Mean
744456|NCT00502242|Secondary|Percentage of Participants With Malignancy|Includes treatment-emergent adverse events based on categorization by the investigator as 'malignancy', regardless of the event preferredterm in MedDRA.|From Day 1 of Ramipril/Placebo to 52 weeks after SRL conversion|Safety population||percentage of participants|||Number
744457|NCT00502242|Secondary|Percentage of Participants With Angioedema|Includes treatment-emergent adverse events based on categorization by the investigator as angioedema, regardless of the event preferred term in MedDRA.|From Day 1 of Ramipril/Placebo to 52 weeks after SRL conversion|Safety population||percentage of participants|||Number
744458|NCT00502242|Secondary|Percentage of Participants With an Infection|Includes treatment-emergent adverse events based on categorization by the investigator as 'infection', regardless of the event preferred term in Medical Dictionary for Regulatory Activities (MedDRA.)|From Day 1 of Ramipril/Placebo to 52 weeks after SRL conversion|Safety population||percentage of participants|||Number
744459|NCT00502242|Secondary|Percentage of Participants Using Statins||Baseline, Pre-SRL (from first dose of ramipril/placebo up to SRL conversion), On-Therapy (up to 52 weeks after SRL conversion), and Off-Therapy Period (up to 56 weeks after SRL conversion)|Safety population; n=number of participants analyzed for the specified parameter at a given visit.||percentage of participants|||Number
744460|NCT00502242|Secondary|Percentage of Participants With Graft Loss at 24 and 52 Weeks Following Conversion to SRL|Graft loss was defined as physical loss (nephrectomy orretransplantation), functional loss (requiring dialysis for ≥56days with no return of graft function), or death.|24 weeks and 52 weeks after conversion|mITT population||percentage of participants|||Number
744461|NCT00502242|Secondary|Number of Participants With BCAR by Severity of First BCAR|Severity was summarized by type (antibody versus T-cell) and by phase: post-SRL (where both on-therapy and off-therapy events are included) and post-SRL (on-therapy). BCAR was categorized using Banff criteria as antibody-mediated (AM) or T-cell. AM BCAR severity was graded as Grade I (mild), Grade II (moderate [mod]), and Grade III (severe). T-cell BCAR severity was graded as 'Grade Ia, Ib (mild), Grade IIa, IIb (mod), and Grade III (severe). If a participant had both T-cell BCAR and antibody-mediated BCAR on the first rejection, the participant was counted in each category. For participants with T-cell BCAR (post-SRL and post-SRL On -Therapy) the p-value could not be calculated and all events were mild in severity.|From Day 1 of SRL conversion to 52 weeks after conversion|mITT population; only participants with BCAR were included in the anlaysis.||participants|||Number
744462|NCT00502242|Secondary|Percentage of Participants With First BCAR at 24 and 52 Weeks Following Conversion to SRL|BCAR was defined according to updated Banff criteria (1997)for renal allograft rejection. Participants without BCAR were censored at the time of withdrawal from the study. Defined as the first BCAR occurring on therapy following conversion to SRL based on the mITT population. Time to first BCAR was defined as the date of first BCAR to date of the first dose of SRL (in weeks). Percentages were estimated using the Kaplan-Meier method for time to event data.|24 weeks and 52 weeks after conversion|mITT population; includes BCAR occurring in the On-Therapy and Off-Therapy Periods||percentage of participants||95% Confidence Interval|Number
744463|NCT00502242|Secondary|Biopsy-Confirmed Acute Rejection (BCAR) - Number of Participants With an Event|BCAR was defined according to updated Banff criteria (1997)for renal allograft rejection. The time to the first BCAR was defined as the date of first BCAR to the date of the first dose of SRL (in weeks). Participants without BCAR were censored at the time of withdrawal from the study.|From Day 1 of SRL conversion to 52 weeks after conversion|mITT population; includes BCAR occurring in On-Therapy and Off-Therapy Periods.||participants|||Number
744464|NCT00502242|Secondary|Change From Baseline in Fasting Lipid Parameters (Millimoles Per Liter [mmol/L]) at 4, 12, 24, and 52 Weeks Following Conversion to SRL|Parameters assessed included (all fasting) total cholesterol (TC), triglycerides, low-density lipoprotein cholesterol (LDL-C), high-densitylipoprotein cholesterol (HDL-C).|4, 12, 24, and 52 weeks after conversion|Safety population; n=number of participants assessed for the specified parameter at a given visit.||mmol/L||Standard Error|Mean
744465|NCT00502242|Secondary|Percentage of Participants Using Red Blood Cell Production Stimulants (Erythropoiesis Stimulating Agents [ESAs])||Baseline, Pre-SRL (from first dose of ramipril/placebo up to SRL conversion), On-Therapy (up to 52 weeks after SRL conversion), and Off-Therapy Period (up to 56 weeks after SRL conversion)|Safety population; n=number of participants analyzed for the specified parameter at a given visit.||percentage of participants|||Number
744466|NCT00502242|Secondary|Percentage of Participants With Hemoglobin Levels ≤100 Grams Per Liter (g/L)||Baseline, Pre-SRL (from first dose of ramipril/placebo up to SRL conversion), On-Therapy (up to 52 weeks after SRL conversion), and Off-Therapy Period (up to 56 weeks after SRL conversion)|Safety population||percentage of participants|||Number
744467|NCT00502242|Secondary|SRL Time-Normalized Trough Concentration (Cmin,TN) by Time Interval|Cmin,TN was determined for SRL using the area method for the intervals: 0–2 weeks, >2–4 weeks, >4–12 weeks, >12–24 weeks, >24–36 weeks and >36–52 weeks using the equation:Cmin,TN = AUCi-j/timej-timeiwhere AUC is the area under the concentration-time curve, i is the beginning of the interval and j is the end of the interval. Cmin,TN was calculated for participants who did not dropout of studies, but were missing concentrations at the interval endpoints by carrying the last observed concentration forward to the interval endpoint.|From Day 1 of SRL conversion to 52 weeks after conversion|Safety population; n=number of participants assessed for the specified parameter for the given time interval; only participants dosed throughout the interval were included.||ng/mL||Standard Deviation|Mean
744468|NCT00502242|Secondary|Percentage of Participants With Potentially Clinically Important Blood Pressure (BP) Values by Diastolic and Systolic BP Category|BP values of potential clinical importance were recorded and categorized as follows: diastolic BP (DBP) ≤50 millimeters of mercury (mmHg) or ≥110 mmHg and systolic BP (SBP) ≤90 mmHg and ≥180 mmHg. Data were summarized for the on-therapy period and the off-therapy period and for the pre-SRL period.|Baseline, Pre-SRL (from first dose of ramipril/placebo up to SRL conversion), On-Therapy (up to 52 weeks after SRL conversion), and Off-Therapy Period (up to 56 weeks after SRL conversion)|Safety population||percentage of participants|||Number
744481|NCT00502320|Primary|Sleep Satisfaction at Baseline and Measured Monthly, as Measured by the Pittsburgh Sleep Quality Index (PSQI)|Self-rated scale to measure quality of sleep via questions regarding sleep latency, duration, efficiency, disturbances, use of sleep medication, and daytime dysfunction. Score ranges from 0-21, higher scores represent more significant sleep disturbance.|Monthly for duration of treatment (up to 4 months)|Intention to Treat analysis; excludes one screen failure.||scores on a scale||Standard Error|Mean
744469|NCT00502242|Secondary|Fraction of Albumin (Milligrams Per Deciliter [mg/dL]) to Protein (mg/dL) in Urine at 24 and 52 Weeks After Conversion to SRL|Baseline fraction was the last value of the pre-SRL conversion period. Only the last value of U p/c or U alb/c was used for analysis if multiple measurements occurred in the same data anlysis interval. Fraction of albumin and protein was calculated only when urine protein was 6.2 mg/dL or higher. For urine albumin, if the value was reported as '<xx.x', the numerical portion of the value was used in the calculation of fraction of albumin and protein.|24 weeks and 52 weeks after conversion|mITT population; n=number of participants assessed for the specified parameter at a given visit. Includes measures collected from On-Therapy and Off-Therapy Periods.||(mg/dL)/(mg/dL)||Standard Deviation|Mean
744470|NCT00502242|Secondary|Abbreviated Modified Diet in Renal Disease (MDRD) Glomerular Filtration Rate (GFR) at Weeks 12, 24, and 52 Following Conversion to SRL|Calculated in millimeters per minute per 1.73 square meters (mL/min/1.73m^2). Age and corresponding creatinine at each visit (Weeks 12, 24, and 52) were used to calculate GFR.|12, 24, and 52 weeks following conversion|mITT population; n=number of participants assessed for the specified parameter at a given visit. Includes measures collected from On-Therapy and Off-Therapy Periods.||mL/min/1.73 m^2||Standard Deviation|Mean
744471|NCT00502242|Secondary|Percentage of Participants Who Discontinued SRL Therapy at 24 and 52 Weeks Following Conversion to SRL|Defined as the percentage of participants who stop SRL (as test article) between the first day of SRL and either Week 24 or Week 52 following conversion to SRL. If a participant had a >14 day gap in SRL use, the stop date of SRL was the date of the last SRL use before it was re-initiated. Participants who early terminate SRL at Week 24 were defined as having SRL stop day less than or equal to (≤) Day 190 (selected as the midpoint between Weeks 24 and 30). Participants who early terminate SRL at Week 52 were defined as having SRL stop day ≤Day 337 (selected as the midpoint between Weeks 44 and 52).|24 weeks and 52 weeks after conversion|mITT population||percentage of participants|||Number
744472|NCT00502242|Secondary|U Alb/c at Baseline and Weeks 3, 4, 8, 12, 24, 30, 36, and 52 Following Conversion to SRL|U alb/c was measured in mg/mg. Baseline U alb/c values were the last values of the pre-SRL conversion period.|Baseline and 3, 4, 8, 12, 24, 30, 36, and 52 weeks after conversion|mITT population; n=number of participants assessed for the specified parameter at a given visit; only participants with nonmissing records of U alb/c were included in the analysis. Includes measures collected from On-Therapy and Off-Therapy Periods.||mg/mg||Standard Deviation|Mean
744473|NCT00502242|Secondary|U p/c at Baseline and Weeks 3, 4, 8, 12, 24, 30, 36, and 52 Following Conversion to SRL|U p/c was measured in milligrams per milligram (mg/mg). The baseline U p/c values were the last values of the pre-SRL conversion period.|Baseline and 3, 4, 8, 12, 24, 30, 36, and 52 weeks after conversion|mITT population; n (number) = number of participants assessed for the specified parameter at a given visit; only participants with nonmissing records of U p/c were included in the analysis. Includes measures collected from On-Therapy and Off-Therapy Periods.||mg/mg||Standard Deviation|Mean
744474|NCT00502242|Secondary|Percentage of Participants With Both U Alb/c <0.5 and U p/c <0.5 at 24 and 52 Weeks Following Conversion to SRL|The U alb/c and U p/c must have been collected on the same day to be counted as the numerator.|24 weeks and 52 weeks after conversion|mITT population; includes assessments from On-Therapy and Off-Therapy Periods.||percentage of participants|||Number
744475|NCT00502242|Secondary|Percentage of Participants With Urinary Albumin to Creatinine Ratio (U Alb/c) <0.5 at 24 and 52 Weeks Following Conversion to SRL|Spot urine sample of albumin and creatinine concentrations were obtained during the pre-SRL conversion period and after conversion.|24 weeks and 52 weeks after conversion|mITT population; includes assessments from On-Therapy and Off-Therapy Periods.||percentage of participants|||Number
744476|NCT00502242|Secondary|Percentage of Participants With U p/c <0.5 at 24 and 52 Weeks Following Conversion to Sirolimus|Spot urine sample of protein and creatinine concentrations were obtained during the pre-SRL conversion period and after conversion.|24 weeks and 52 weeks after conversion|mITT population; includes assessments from On-Therapy and Off-Therapy Periods.||percentage of participants|||Number
744477|NCT00502242|Secondary|Percentage of Participants Who Had a Dose Escalation in Randomized Test Article (Ramipril or Placebo) by 52 Weeks Following Conversion to SRL|Defined as the time from the first dose of SRL administration to the first dose escalation of randomized test article (ramipril or placebo; in weeks), or censored on the day that a participant stopped the combination of SRL and randomized test article (ramipril or placebo) if the participants did not experience any ramipril/placebo dose escalation following conversion to SRL. Dose-escalation was defined as an increase in total daily dose of ramipril/placebo compared to Day 1 post conversion. Percentage was estimated using Kaplan-Meier method for time to event data.|From Day 1 of SRL conversion to 52 weeks after conversion|mITT population||percentage of participants||95% Confidence Interval|Number
744478|NCT00502242|Primary|Percentage of Participants Who Had Initiated Losartan Therapy at 52 Weeks Following Conversion to SRL|The event for each participant was defined as the initiation of losartan while on SRL and ramipril/placebo combination therapy. Participants who started losartan prior to SRL administration were not counted as events. Percentage was estimated using Kaplan-Meier method for time to event data.|From Day 1 of SRL conversion to 52 weeks after conversion|Modified Intent to Treat (mITT) population: all participants in the safety population who took at least one dose of SRL.||percentage of participants||95% Confidence Interval|Number
744479|NCT00502320|Secondary|Depressive Symptoms at Baseline and Measured Monthly, as Measured by the Structured Interview Guide for the Hamilton Depression Rating - Seasonal Affective Disorder (SIGH-SAD)|Clinician-rated measure of mood; evaluates classical 21 Hamilton Depression items, and 8-item subscale measuring atypical depression symptoms which commonly occur during SAD episodes. Score ranges from 0-89, higher scores indicate higher levels of depression.|Monthly for duration of treatment (up to 4 months)|Intention to Treat analysis; excludes one screen failure.||scores on a scale||Standard Error|Mean
744480|NCT00502320|Secondary|Depressive Symptoms at Baseline and Measured Monthly, as Measured by the Zung Depression Scale (ZDS)|Self-rated scale to measure severity of depressive symptoms. Score ranges from 25-100, higher scores reflect more depression.|Monthly for duration of treatment (up to 4 months)|Intention to Treat analysis; excludes one screen failure.||scores on a scale||Standard Error|Mean
744656|NCT00503113|Secondary|Relative Change From Baseline in Actual GFR (Using Abbreviated MDRD Formula)|Change (mL/min) from baseline in actual GFR (abbreviated MDRD formula using the patient's actual body surface area) after 9 months (or 40 weeks) of treatment.|Baseline and 9 months|PP Population||mL/min||Standard Deviation|Mean
744482|NCT00502593|Secondary|Number of Subjects With Adverse Events of Specific Interest (AESIs)|AESIs are adverse events such as clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. AESIs assessed included neuroinflammatory disorders such as cranial nerve disorders, multiple sclerosis,transverse myelitis, Guillain-Barré syndromeor neuritis), musculoskeletal disorders (such as systemic lupus erythematosus, cutaneous lupus, polymyositis, rheumatoid arthritis, reactive arthritis, psoriatic arthropathy, or undifferentiated spondyloarthropathy), gastrointestinal disorders (such as Crohn’s disease, ulcerative colitis, ulcerative proctitis, celiac disease), metabolic diseases (such as autoimmune thyroiditis, Addison’s disease). skin disorders (such as psoriasis, vitiligo, Raynaud’s phenomenon, or autoimmune bullous skin diseases), and other conditions as autoimmune hemolytic anemia, thrombocytopenias, antiphospholipid syndrome, vasculitis, autoimmune hepatitis, or sarcoidosis.|Throughout the entire study period, from Day 0 to Month 24|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom safety data were available.||Subjects|||Number
744483|NCT00502593|Secondary|Number of Seroconverted Subjects Against 2 Strains of Influenza Disease as Regards to Neutralizing Antibody Response|A seroconverted subject as regards to neutralizing antibody response was a subject with a minimum 4-fold increase in neutralizing antibody titer at post-vaccination. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO) strains. Results presented are for subjects participating in Phase A of the study. Subjects participating to Phases B and C of the study were not analysed at these persistence time points for this outcome.|At Months 6, 12 and 24.|The analysis was performed on the According-to-Protocol cohort for persistence, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component on Month 6/Day 180, Month 12 and Month 24.||Subjects|||Number
744484|NCT00502593|Secondary|Titers for Serum Neutralizing Antibodies Against 2 Strains of Influenza Disease|Titers of serum neutralizing antibodies are presented as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off value of 1:28. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO) strains. Results presented are for subjects participating in Phase A of the study. Subjects participating to Phases B and C of the study were not analysed at these persistence time points for this outcome.|At Months 6, 12 and 24|The analysis was performed on the According-to-Protocol cohort for persistence, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component on Month 6/Day 180, Month 12 and Month 24.||Titer||95% Confidence Interval|Geometric Mean
744485|NCT00502593|Secondary|Number of Seroconverted Subjects Against One Strain of Influenza Disease With Respect to Serum Neutralizing Antibodies|A seroconverted subject as regards to serum neutralizing antibodies against influenza disease was a subject with a minimum 4-fold increase in serum neutralizing antibody titer at post-vaccination. The flu strain assessed was A/Vietnam/1194/2004 (A/VIET). This outcome presents results for subjects participating to Phase C of the study.|At Days 21 and 42|The analysis was based on the According to protocol (ATP) cohort for immunogenicity, which included all subjects meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria and no major deviation from protocol, for whom immunogenicity data for at least one antigen were available.||Subjects|||Number
744486|NCT00502593|Secondary|Number of Seroconverted Subjects Against One Strain of Influenza Disease With Respect to Serum Neutralizing Antibodies|A seroconverted subject as regards to serum neutralizing antibodies against influenza disease was a subject with a minimum 4-fold increase in serum neutralizing antibody titer at post-vaccination. The flu strain assessed was A/Vietnam/1194/2004 (A/VIET). This outcome presents results for subjects participating to Phase B of the study.|At Days 21 and 42|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, e.g. for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination||Subjects|||Number
744487|NCT00502593|Secondary|Number of Seroconverted Subjects Against One Strain of Influenza Disease With Respect to Serum Neutralizing Antibodies|A seroconverted subject as regards to serum neutralizing antibodies against influenza disease was a subject with a minimum 4-fold increase in serum neutralizing antibody titer at post-vaccination. The flu strain assessed was A/Vietnam/1194/2004 (A/VIET). This outcome presents results for subjects participating to Phase A of the study.|At Days 21 and 42|The analysis was based on the According to protocol (ATP) cohort for immunogenicity, which included all subjects meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria and no major deviation from protocol, for whom immunogenicity data for at least one antigen were available.||Subjects|||Number
744488|NCT00502593|Secondary|Titers for Serum Neutralizing Antibodies Against 1 Strain of Influenza Disease|Titers of serum neutralizing antibodies are presented as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off value of 1:28. The influenza strain assessed was A/Vietnam/1194/04 (A/VIET). Results presented are for subjects participating in Phase C of the study.|At Days 0, 21 and 42|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, e.g. for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Titer||95% Confidence Interval|Geometric Mean
744489|NCT00502593|Secondary|Titers for Serum Neutralizing Antibodies Against 1 Strain of Influenza Disease|Titers of serum neutralizing antibodies are presented as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off value of 1:28. The influenza strain assessed was A/Vietnam/1194/04 (A/VIET). Results presented are for subjects participating in Phase B of the study.|At Days 0, 21 and 42|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, e.g. for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Titer||95% Confidence Interval|Geometric Mean
744564|NCT00502775|Secondary|Mean Change From Baseline in Pre-Dose Instantaneous Total Nasal Symptom Score (iTNSS)|Subjects assessed four nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing). The sum of the four nasal symptoms comprised the total nasal symptom score (TNSS).Instantaneous rating represented symptoms at the time of the assessment. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.|Baseline and Weeks 1-2|||Score on a Scale||Standard Error|Mean
744490|NCT00502593|Secondary|Titers for Serum Neutralizing Antibodies Against 1 Strain of Influenza Disease|Titers of serum neutralizing antibodies are presented as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off value of 1:28. The influenza strain assessed was A/Vietnam/1194/04 (A/VIET).Results presented are for subjects participating in Phase A of the study|At Days 0, 21 and 42|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, e.g. for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Titer||95% Confidence Interval|Geometric Mean
744491|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase C|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents LDH results, for subjects participating to Phase C of the study.|At Days 0, 21 and 42 and at Months 6, 12 and 24|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.||Subjects|||Number
744492|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase C|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents CREA results, for subjects participating to Phase C of the study.|At Days 0, 21 and 42 and at Months 6, 12 and 24|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.||Subjects|||Number
744493|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase C|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents CPK results, for subjects participating to Phase C of the study.|At Days 0, 21, and 42, and at Months 6, 12 and 24|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.||Subjects|||Number
744494|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Aspartate Aminotransferase (AST) in Study Phase C|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents AST results, for subjects participating to Phase C of the study.|At Days 0, 21, and 42, and at Months 6, 12 and 24|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, e.g. for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination||Subjects|||Number
744495|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase B|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents CPK results, for subjects participating to Phase B of the study.|At Days 0, 21, and 42, and at Months 6, 12 and 24|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.||Subjects|||Number
744496|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase C|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents ALT results, for subjects participating to Phase C of the study.|At Days 0, 21, and 42, and at Months 6, 12 and 24|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.||Subjects|||Number
744497|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase C|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents BUN results, for subjects participating to Phase C of the study.|At Days 0, 21 and 42 and at Months 6, 12 and 24|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.||Subjects|||Number
744498|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase B|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents BUN results, for subjects participating to Phase B of the study.|At Days 0, 21, and 42, and at Months 6, 12 and 24|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.||Subjects|||Number
744565|NCT00502775|Secondary|Mean Change From Baseline in 24 Hour Reflective Total Ocular Symptoms Score (rTOSS)|Subjects assessed three ocular symptoms (itching/ burning eyes, tearing/watering eyes, and eye redness). The sum of the 3 ocular symptoms comprised the total ocular symptom score (TOSS). Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.|Baseline and Weeks 1-2|||Score on a Scale||Standard Error|Mean
744499|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase B|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents LDH results, for subjects participating to Phase B of the study.|At Days 0, 21, and 42, and at Months 6, 12 and 24|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.||Subjects|||Number
744500|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase B|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents CREA results, for subjects participating in Phase B of the study.|At Days 0, 21 and 42 and at Month 6, 12 and 24|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.||Subjects|||Number
744501|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Aspartate Aminotransferase (AST) in Study Phase B|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents AST results, for subjects participating to Phase B of the study.|At Days 0, 21, and 42, and at Months 6, 12 and 24|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.||Subjects|||Number
744502|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase B|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents AST results, for subjects participating to Phase B of the study.|At Days 0, 21, and 42, and at Months 6, 12 and 24|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.||Subjects|||Number
744503|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase A|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents LDH results for subjects participating in Phase A of the study.|At Days 0, 21, and 42, and at Months 6, 12 and 24|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.||Subjects|||Number
744504|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase A|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents CPK results for subjects participating in Phase A of the study.|At Days 0, 21, and 42, and at Months 6, 12 and 24|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.||Subjects|||Number
744505|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase A|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents CREA results, for subjects participating in Phase A of the study.|At Days 0, 21, and 42, and at Months 6, 12 and 24|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.||Subjects|||Number
744506|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase A|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents BUN results for subjects participating in Phase A of the study.|At Days 0, 21, and 42, and at Months 6, 12 and 24|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.||Subjects|||Number
744507|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Aspartate Aminotransferase (AST) in Study Phase A|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents AST results for subjects participating in Phase A of the study.|At Days 0, 21, and 42, and at Months 6, 12 and 24|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.||Subjects|||Number
744542|NCT00502593|Primary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).|At Month 6|The analysis was performed on the According-to-Protocol cohort for persistence, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component on Month 6/Day 180, Month 12 and Month 24.||Fold||95% Confidence Interval|Geometric Mean
744508|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase A|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents ALT results for subjects participating in Phase A of the study.|At Days 0, 21, and 42, and at Months 6, 12 and 24|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.||Subjects|||Number
744509|NCT00502593|Primary|Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH) in Study Phase C|Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for LDH for subjects participating in Phase C of the study.|At Days 21, and 42, and at Months 6, 12 and 24|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.||Subjects|||Number
744510|NCT00502593|Primary|Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK) in Study Phase C|Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for CPK for subjects participating in Phase C of the study.|At Days 21, and 42, and at Months 6, 12 and 24|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom safety data were available.||Subjects|||Number
744511|NCT00502593|Primary|Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase C|Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for CREA for subjects participating in Phase C of the study.|At Days 21, and 42, and at Months 6, 12 and 24|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom safety data were available.||Subjects|||Number
744512|NCT00502593|Primary|Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C|Changes from baseline are categorised as below, within(normal), or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for BUN for subjects participating in Phase C of the study.|At Days 21, and 42, and at Months 6, 12 and 24|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom safety data were available.||Subjects|||Number
744513|NCT00502593|Primary|Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase C|Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for AST for subjects participating in Phase C of the study.|At Days 21, and 42, and at Months 6, 12 and 24|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.||Subjects|||Number
744514|NCT00502593|Primary|Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase C|Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for ALT for subjects participating in Phase C of the study.|At Days 21, and 42, and at Months 6, 12 and 24|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.||Subjects|||Number
744515|NCT00502593|Primary|Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase B|Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for LDH for subjects participating in Phase B of the study.|At Days 21, and 42, and at Months 6, 12 and 24|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.||Subjects|||Number
744516|NCT00502593|Primary|Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase B|Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for CREA for subjects participating in Phase B of the study.|At Days 21, and 42, and at Months 6, 12 and 24|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.||Subjects|||Number
744517|NCT00502593|Primary|Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase B|Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for CPK for subjects participating in Phase B of the study.|At Days 21, and 42, and at Months 6, 12 and 24|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.||Subjects|||Number
744518|NCT00502593|Primary|Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase B|Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for BUN for subjects participating in Phase B of the study.|At Days 21, and 42, and at Months 6, 12 and 24|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.||Subjects|||Number
744519|NCT00502593|Primary|Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase B|Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for AST for subjects participating in Phase B of the study.|At Days 21, and 42, and at Months 6, 12 and 24|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.||Subjects|||Number
744520|NCT00502593|Primary|Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B|Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for ALT for subjects participating in Phase B of the study.|At Days 21 and 42 and Months 6, 12 and 24|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.||Subjects|||Number
744521|NCT00502593|Primary|Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A|Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for LDH for subjects participating in Phase A of the study|At Days 21 and 42 and Months 6, 12 and 24|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom safety data were available.||Subjects|||Number
744522|NCT00502593|Primary|Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase A|Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for CREA for subjects participating in Phase A of the study.|At Days 21 and 42 and Months 6, 12 and 24|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom safety data were available.||Subjects|||Number
744531|NCT00502593|Primary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, fever (axillary temperature above or equal (≥) 37.5°C), irritability, loss of appetite, shivering, sweating and vomiting. Any = occurrence of a symptom regardless of intensity or relationship to vaccination. Grade 3 = general symptom that prevented normal activity. Grade 3 temperature = axillary temperature > 39.0°C. Related = symptom assessed as causally related to study vaccination. This outcome presents results for subjects aged between 3 and 5 years participating in Phases A, B and C of the study.|During the 7-day (Days 0-6) follow-up period after any vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.||Subjects|||Number
744523|NCT00502593|Primary|Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A|Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for CPK for subjects participating in Phase A of the study.|At Days 21 and 42 and Months 6, 12 and 24|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom safety data were available.||Subjects|||Number
744524|NCT00502593|Primary|Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A|Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for BUN for subjects participating in Phase A of the study.|At Days 21 and 42 and Months 6, 12 and 24|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom safety data were available.||Subjects|||Number
744525|NCT00502593|Primary|Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A|Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for AST for subjects participating in Phase A of the study.|At Days 21 and 42 and Months 6, 12 and 24|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom safety data were available.||Subjects|||Number
744526|NCT00502593|Primary|Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase A|Changes from baseline are categorised as below, within(normal), or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for ALT for subjects participating in Phase A of the study.|At Days 21 and 42 and Months 6, 12 and 24|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.||Subjects|||Number
744527|NCT00502593|Primary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events|"An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event. Grade 3 AE = AE that prevented normal activity, everyday activities, or required intervention of a physician/healthcare provider. Related = symptom assessed as causally related to study vaccination."|During a 21 day follow-up period after the first vaccination, during a 30-day follow-up period after the second vaccination|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom safety data were available.||Subjects|||Number
744528|NCT00502593|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE = any SAE regardless of intensity or relationship to vaccination.|During the entire study (Day 0 to Month 24)|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom safety data were available.||Subjects|||Number
744529|NCT00502593|Primary|Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms|Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling at the injection site. Any = occurrence of a symptom regardless of intensity. Grade 3 pain = significant pain at rest/ that prevented normal activities. Grade 3 ecchymosis/induration/redness/swelling = ecchymosis/induration/redness/swelling larger than (>) 100 millimeters (mm). All solicited local symptoms were considered to be related to study vaccination. This outcome presents results from subjects participating to Phase B of the study.|During the 7-day follow-up period after each vaccination|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.||Subjects|||Number
744530|NCT00502593|Primary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms were arthralgia, fatigue, headache, muscle aches, shivering and fever, assessed as oral temperature above or equal (≥) 37.0 degrees Celsius (°C). Any = occurrence of a symptom regardless of intensity or relationship to vaccination. Grade 3 = general symptom that prevented normal activity, everyday activities, or required intervention of a physician/healthcare provider. Grade 3 fever= oral temperature ≥ 39.0°C. Related = symptom assessed as causally related to study vaccination. This outcome presents results related to subjects aged 6 to 9 years participating in the study phases A, B and C.|During the 7-day (Days 0-6) follow-up period after any vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.||Subjects|||Number
744657|NCT00503113|Secondary|Absolute Change From Baseline in Actual GFR (Using Cockcroft-Gault [CG] Formula)|Change (mL/min) from baseline in actual GFR (using Cockcroft-Gault [CG] formula) after 9 months (or 40 weeks) of treatment.|Baseline and 9 months|PP Population||mL/min||Standard Deviation|Mean
744532|NCT00502593|Primary|Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms|Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling at the injection site. Any = occurrence of a symptom regardless of intensity. Grade 3 pain = significant pain at rest/ that prevented normal activities. Grade 3 ecchymosis/induration/redness/swelling = ecchymosis/induration/redness/swelling larger than (>) 100 millimeters (mm). All solicited local symptoms were considered to be related to study vaccination. This outcome presents results from subjects participating in Phase C of the study.|During the 7-day follow-up period after each vaccination|The analysis was based on theTotal Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.||Subjects|||Number
744533|NCT00502593|Primary|Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms|Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling at the injection site. Any = occurrence of a symptom regardless of intensity. Grade 3 pain = significant pain at rest/ that prevented normal activities. Grade 3 ecchymosis/induration/redness/swelling = ecchymosis/induration/redness/swelling larger than (>) 100 millimeters (mm). All solicited local symptoms were considered to be related to study vaccination. This outcome presents results from subjects participating in Phase A of the study.|During the 7 day follow-up period after each vaccination|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.||Subjects|||Number
744534|NCT00502593|Primary|Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease|A seroprotected subject was defined as a vaccinated subject with a serum HI antibody titer ≥ 1:40, a level of HI antibody that has been viewed as correlating with protection against influenza. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/5/2005 (A/INDO).|At Month 24|The analysis was performed on the According-to-Protocol cohort for persistence, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component on Month 6/Day 180, Month 12 and Month 24.||Subjects|||Number
744535|NCT00502593|Primary|Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease|A seroprotected subject was defined as a vaccinated subject with a haemagglutination-inhibition (HI) antibody titer above or equal to the seroprotection threshold of 1:40. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/5/2005 (A/INDO)|At Month 12|The analysis was performed on the According-to-Protocol cohort for persistence, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component on Month 6/Day 180, Month 12 and Month 24.||Subjects|||Number
744536|NCT00502593|Primary|Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease|A seroprotected subject was defined as a vaccinated subject with a haemagglutination-inhibition (HI) antibody titer above or equal to the seroprotection threshold of 1:40. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/5/2005 (A/INDO)|At Month 6|The analysis was performed on the According-to-Protocol cohort for persistence, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component on Month 6/Day 180, Month 12 and Month 24.||Subjects|||Number
744537|NCT00502593|Primary|Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease|A seroprotected subject was defined as a vaccinated subject with a haemagglutination-inhibition (HI) antibody titer above or equal to the seroprotection threshold of 1:40. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/5/2005 (A/INDO).|At Day 42|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, e.g. for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
744538|NCT00502593|Primary|Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease|A seroprotected subject was defined as a vaccinated subject with a haemagglutination-inhibition (HI) antibody titer above or equal to the seroprotection threshold of 1:40. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/5/2005 (A/INDO).|At Day 21|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, e.g. for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
744539|NCT00502593|Primary|Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease|A seroprotected subject was defined as a vaccinated subject with a haemagglutination-inhibition (HI) antibody titer above or equal to the seroprotection threshold of 1:40. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/5/2005 (A/INDO).|At Day 0|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, e.g. for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
744540|NCT00502593|Primary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (A/VIET) and A/Indonesia/5/2005 (A/INDO).|At Month 24|The analysis was performed on the According-to-Protocol cohort for persistence, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component on Month 6/Day 180, Month 12 and Month 24.||Fold||95% Confidence Interval|Geometric Mean
744541|NCT00502593|Primary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (A/VIET) and A/Indonesia/5/2005 (A/INDO).|At Month 12|The analysis was performed on the According-to-Protocol cohort for persistence, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component on Month 6/Day 180, Month 12 and Month 24.||Fold||95% Confidence Interval|Geometric Mean
744658|NCT00503113|Primary|Absolute Change From Baseline in Actual Glomerular Filtration Rate (GFR) (Using Abbreviated Modification of Diet in Renal Disease [MDRD] Formula)|The primary parameter of the study was the change (mL/min) from baseline in actual GFR (abbreviated MDRD formula using the patients’ actual body surface area) after 9 months (or 40 weeks) of treatment.|Baseline and 9 months|Per Protocol (PP) Population||mL/min||Standard Deviation|Mean
744543|NCT00502593|Primary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).|At Day 42|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, e.g. for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Fold||95% Confidence Interval|Geometric Mean
744544|NCT00502593|Primary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).|At Day 21|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, e.g. for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination||Fold||95% Confidence Interval|Geometric Mean
744545|NCT00502593|Primary|Number of Seroconverted Subjects Against 2 Strains of Influenza Disease|A seroconverted subject was a subject with a pre-vaccination serum haemagglutination-inhibition (HI) antibody titer < 1:10 and a post-vaccination HI antibody titer ≥1:40 or a pre-vaccination HI antibody titer ≥ 1:10 and at least four-fold increase in post-vaccination HI antibody titer. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).|At Month 24|The analysis was performed on the According-to-Protocol cohort for persistence, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component on Month 6/Day 180, Month 12 and Month 24.||Subjects|||Number
744546|NCT00502593|Primary|Number of Seroconverted Subjects Against 2 Strains of Influenza Disease|A seroconverted subject was a subject with a pre-vaccination serum haemagglutination-inhibition (HI) antibody titer < 1:10 and a post-vaccination HI antibody titer ≥1:40 or a pre-vaccination HI antibody titer ≥ 1:10 and at least four-fold increase in post-vaccination HI antibody titer. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).|At Month 12|The analysis was performed on the According-to-Protocol cohort for persistence, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component on Month 6/Day 180, Month 12 and Month 24.||Subjects|||Number
744547|NCT00502593|Primary|Number of Seroconverted Subjects Against 2 Strains of Influenza Disease|A seroconverted subject was a subject with a pre-vaccination serum haemagglutination-inhibition (HI) antibody titer < 1:10 and a post-vaccination HI antibody titer ≥1:40 or a pre-vaccination HI antibody titer ≥ 1:10 and at least four-fold increase in post-vaccination HI antibody titer. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).|At Month 6|The analysis was performed on the According-to-Protocol cohort for persistence, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component on Month 6/Day 180, Month 12 and Month 24.||Subjects|||Number
744548|NCT00502593|Primary|Number of Seroconverted Subjects Against 2 Strains of Influenza Disease|A seroconverted subject was a subject with a pre-vaccination serum haemagglutination-inhibition (HI) antibody titer < 1:10 and a post-vaccination HI antibody titer ≥1:40 or a pre-vaccination HI antibody titer ≥ 1:10 and at least four-fold increase in post-vaccination HI antibody titer. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).|At Day 42|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, e.g. for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
744549|NCT00502593|Primary|Number of Seroconverted Subjects Against 2 Strains of Influenza Disease|A seroconverted subject was a subject with a pre-vaccination serum haemagglutination-inhibition (HI) antibody titer below (<) 1:10 and a post-vaccination HI antibody titer above than or equal to (≥)1:40 or a pre-vaccination HI antibody titer ≥ 1:10 and at least four-fold increase in post-vaccination HI antibody titer. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).|At Day 21|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, e.g. for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
744550|NCT00502593|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|Titers of serum HI antibodies are presented as geometric mean titers (GMTs). The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO). The cut-off of the assay was the seropositivity cut-off value of 1:10|At Month 24|The analysis was performed on the According-to-Protocol cohort for persistence, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component on Month 6/Day 180, Month 12 and Month 24.||Titer||95% Confidence Interval|Geometric Mean
744551|NCT00502593|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (A/VIET) and A/Indonesia/5/2005 (A/INDO). The cut-off of the assay was the seropositivity cut-off value of 1:10|At Month 12|The analysis was performed on the According-to-Protocol cohort for persistence, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component on Month 6/Day 180, Month 12 and Month 24.||Titer||95% Confidence Interval|Geometric Mean
744552|NCT00502593|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|Titers of serum HI antibodies are presented as geometric mean titers (GMTs). The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO). The cut-off of the assay was the seropositivity cut-off value of 1:10.|At Month 6|The analysis was performed on the According-to-Protocol cohort for persistence, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component on Month 6/Day 180, Month 12 and Month 24.||Titer||95% Confidence Interval|Geometric Mean
747609|NCT00530842|Secondary|Static Lung Volumes|Trough TGV(FRC) (Thoracic Gas Volume) after 8 weeks (measured by bodyphlethysmography)|8 weeks|FAS using imputed values||Litres||Standard Error|Mean
744553|NCT00502593|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (A/VIET) and A/Indonesia/5/2005 (A/INDO). The cut-off of the assay was the seropositivity cut-off value of 1:10|At Day 42|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, e.g. for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination||Titer||95% Confidence Interval|Geometric Mean
744554|NCT00502593|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|Titers of serum HI antibodies are presented as geometric mean titers (GMTs). The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO). The cut-off of the assay was the seropositivity cut-off value of 1:10|At Day 21|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, e.g. for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination||Titer||95% Confidence Interval|Geometric Mean
744555|NCT00502593|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|Titers of serum HI antibodies are presented as geometric mean titers (GMTs). The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO). The cut-off of the assay was the seropositivity cut-off value of 1:10.|At Day 0|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, e.g. for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Titer||95% Confidence Interval|Geometric Mean
744556|NCT00502671|Secondary|Percentage of Participants With Early Withdrawal or Discontinuation Due to an AE|The postmarketing safety profile of capecitabine was evaluated by collection of AEs, clinical laboratory data, vital signs, and other findings from physical examination. Abnormalities in these findings were captured as AEs, defined as any untoward medical occurrence in a study participant regardless of the suspected cause. The percentage of participants with early withdrawal or treatment discontinuation due to an AE was calculated as [number of participants with event divided by number analyzed] multiplied by 100.|Up to 25 weeks (from Baseline to the end of safety follow-up)|Safety Population.||percentage of participants|||Number
744557|NCT00502671|Primary|Percentage of Participants With an Adverse Event (AE), Serious AE, or Death Due to an AE|The postmarketing safety profile of capecitabine was evaluated by collection of AEs, clinical laboratory data, vital signs, and other findings from physical examination. Abnormalities in these findings were captured as AEs, defined as any untoward medical occurrence in a study participant regardless of the suspected cause. Serious AEs were those which, at any dose, met one or more of the following criteria: resulted in fatality, were life-threatening, necessitated new or prolonged existing hospitalization, produced persistent or significant disability, resulted in congenital anomaly or birth defect, were considered medically significant, or required intervention to prevent any of the aforementioned outcomes. Those specific serious AEs which resulted in fatality were also reported separately. The percentage of participants with an AE, serious AE, or AE resulting in death was calculated as [number of participants with event divided by number analyzed] multiplied by 100.|Up to 25 weeks (from Baseline to the end of safety follow-up)|Safety Population.||percentage of participants|||Number
744558|NCT00502697|Secondary|Maternal Length of Stay at Delivery|Number of maternal hospital days associated with delivery|Hospital discharge point following delivery|Of the 211 participants, data on length of stay at delivery were available for 194 women. The most common reason for the lack of this information was that the birth did not take place at the study’s medical center.||days||Full Range|Median
744559|NCT00502697|Primary|Infant Gestational Age|Infant gestational age was determined by the weeks and days gestation documented in the maternal delivery record.|Time of delivery|ITT analysis used with all participants that birth information could be obtained.||weeks||Inter-Quartile Range|Median
744560|NCT00502775|Secondary|Mean Change From Baseline at Day 15 for Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ)|Subjects completed the 16-item Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ)to assess nocturnal rhinitis-related quality of life. The NRQLQ measures the functional problems most troublesome to patients with nocturnal allergy symptoms. Each question scored from 0-6 with higher scores indicating more nocturnal impairment.|Baseline, Day 15 or if Early Withdrawal Day|Ten placebo subjects, six FFNS subjects, and four fexofenadine subjects had no overall NRQLQ score at endpoint, indicating either a missing score for one or more of the NRQLQ domains, a missing baseline score, or both. One additional FFNS patient had no on-treatment NRQLQ data.||Score on a Scale||Standard Error|Mean
744561|NCT00502775|Secondary|Mean Change From Baseline in Evening Peak Nasal Inspiratory Flow (PNIF)|Subjects used a portable hand-held inspiratory flow meter to measure and record PNIF in the evening. Three measurements were taken and the highest measurement was recorded in the electronic diary. A positive change signifies improved nasal air flow.|Baseline and Weeks 1-2|Two subjects in the placebo group & two in the FFNS group recorded no data during the two-week treatment period.||Score on a Scale||Standard Error|Mean
744562|NCT00502775|Secondary|Mean Change From Baseline in Morning Peak Nasal Inspiratory Flow (PNIF)|Subjects used a portable hand-held inspiratory flow meter to measure and record PNIF in the morning prior to taking the study medication. Three measurements were taken and the highest measurement was recorded in the electronic diary. A positive change signifies improved nasal air flow.|Baseline and Weeks 1-2|Two subjects in the placebo group & three in the FFNS group recorded no data during the two-week treatment period.||Score on a Scale||Standard Error|Mean
744563|NCT00502775|Secondary|Mean Change From Baseline in Pre-Dose Instantaneous Total Ocular Symptom Score (iTOSS)|Subjects assessed three ocular symptoms (itching/ burning eyes, tearing/watering eyes, and eye redness). The sum of the four ocular symptoms comprised the total nasal symptom score (TOSS).Instantaneous rating represented symptoms at the time of the assessment. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.|Baseline and Weeks 1-2|||Score on a Scale||Standard Error|Mean
744703|NCT00503906|Primary|Median Progression-Free Survival|Progression-free survival will be measured from the first dose date to the earliest date of documented evidence of progressive disease or the date of death due to any causes, whichever occurs first.|Up to 24 months|||months||95% Confidence Interval|Median
744566|NCT00502775|Secondary|Mean Change From Baseline in Daytime Reflective Total Ocular Symptom Score (D-rTOSS)|Subjects assessed three ocular symptoms (itching/ burning eyes, tearing/watering eyes, and eye redness). The sum of the 3 ocular symptoms comprised the total ocular symptom score (TOSS). Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.|Baseline and Weeks 1-2|||Score on a Scale||Standard Error|Mean
744567|NCT00502775|Secondary|Mean Change From Baseline in Nighttime Reflective Total Ocular Symptom Score (N-rTOSS)|Subjects assessed three ocular symptoms (itching/ burning eyes, tearing/watering eyes, and eye redness). The sum of the 3 ocular symptoms comprised the total ocular symptom score (TOSS). Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.|Baseline and Weeks 1-2|||Score on a Scale||Standard Error|Mean
744568|NCT00502775|Secondary|Mean Change From Baseline in 24 Hour Reflective Total Nasal Symptom Score (24 Hour rTNSS)|Subjects assessed four nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing). The sum of the four nasal symptoms comprised the total nasal symptom score (TNSS).Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.|Baseline and Weeks 1-2|||Score on a Scale||Standard Error|Mean
744569|NCT00502775|Secondary|Mean Change From Baseline in Daytime Reflective Total Nasal Symptom Score (D-rTNSS)|Subjects assessed four nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing). The sum of the four nasal symptoms comprised the total nasal symptom score (TNSS). Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.|Baseline and Weeks 1-2|||Score on a Scale||Standard Error|Mean
744570|NCT00502775|Secondary|Mean Change From Baseline in Nighttime Reflective Total Nasal Symptom Score (N-rTNSS)|Subjects assessed four nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing). The sum of the four nasal symptoms comprised the total nasal symptom score (TNSS). Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.|Baseline and Weeks 1-2|||Score on a Scale||Standard Error|Mean
744571|NCT00502775|Primary|Mean Change From Baseline in the Nighttime Symptom Score (NSS)|Questions include: 1. Nasal congestion on awakening (Score: 0=none, 1=mild, 2=moderate, 3=severe); 2. Difficulty going to sleep (Score: 0=not at all, 1=little, 2=moderately, 3=very); 3. Nighttime awakenings (Score: 0=not at all, 1=once, 2=more than once, 3=felt like awake all night). The sum of the ratings for the three items comprises the NSS.|Baseline and Weeks 1-2|One analysis population was defined for this study, the Intent-to-Treat population. . The Intent-to-Treat (ITT) population included all subjects randomized to double-blind treatment. This population formed the basis for all summaries of demographic, background, efficacy, and safety data.||Score on a Scale||Standard Error|Mean
744572|NCT00502801|Secondary|Clinical Response Rates at the Late Follow-up Assessment.|"The table below shows the percentage of subjects who had a clinical response of “clinical cure” at the Late Follow-up Visit as assigned by the medical monitor. A clinical response of clinical cure is defined as no further antibacterial therapy needed for treatment of the infection."|28 to 35 days after last dose of study therapy|Clinically Evaluable: Subset of the ITT population who received at least 5 days of study medication unless deemed a clinical failure with at least 2 full days of therapy, and excluding those subjects with a clinical outcome of Not Evaluable at the TOC assessment.||Percentage of participants|||Number
744573|NCT00502801|Primary|Clinical Response Rates and 95% Confidence Intervals at the Test-of-Cure Assessment.|The table below shows the percentage of subjects who had a clinical response of “clinical cure” at the Late Follow-up Visit as assigned by the medical monitor. A clinical response of “clinical cure” is defined as no further antibacterial therapy needed for treatment of the infection.|5 to 21 days after the last dose of study therapy, or at early termination.|Clinically Evaluable: Subset of the ITT population who received at least 5 days of study medication unless deemed a clinical failure with at least 2 full days of therapy, and excluding those subjects with a clinical outcome of Not Evaluable at the TOC assessment.||Percentage of participants||95% Confidence Interval|Number
744574|NCT00502840|Secondary|Rheumatoid Factor (RF)|RF measured in international units per milliliter (IU/mL) was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). Baseline was defined as the original baseline score from assessment performed in Study ML19070.|Baseline and Week 24|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||IU/mL||Standard Deviation|Mean
744575|NCT00502840|Secondary|Erythrocyte Sedimentation Rate|ESR mean scores measured in mm/hr at was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). Baseline was defined as the original baseline score from assessment performed in Study ML19070.|Baseline and Week 24|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||mm/hr||Standard Deviation|Mean
744576|NCT00502840|Secondary|C-Reactive Protein|CRP measured in milligrams per deciliter (mg/dL) was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). Baseline was defined as the original baseline score from assessment performed in Study ML19070.|Baseline and Week 24|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||mg/dL||Standard Deviation|Mean
744577|NCT00502840|Secondary|Patient's Assessment of Pain|"Patient Assessment of Pain was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). Baseline was defined as the original baseline score from assessment performed in Study ML19070. Participants were to assess their current level of pain on a 100 mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as no pain and the right-hand (100 mm) as unbearable pain."|Baseline and Week 24|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||mm||Standard Deviation|Mean
744600|NCT00502853|Secondary|X-Rays: Right Hand Total Score|Right hand total scores as measured by X-rays examining erosion and joint space narrowing. Total score was calculated as the sum of the erosion score and the joint space narrowing score and scores ranged from 0 (best possible outcome) to 180 (worst possible outcome).|Baseline and Week 24|Safety Population; only participants with values at both Baseline and Week 24 were included in the analysis.||units on a scale||Standard Deviation|Mean
744578|NCT00502840|Secondary|Patient's Global Assessment of Disease Activity|"Patient Global Assessment of Disease Activity was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). Baseline was defined as the original baseline score from assessment performed in Study ML19070. Participants were to assess the disease activity on a 100-mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as no disease activity (symptom-free and no arthritis symptoms) and the right hand extreme (100 mm) as maximum disease activity (maximum arthritis disease activity)."|Baseline and Week 24|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||mm||Standard Deviation|Mean
744579|NCT00502840|Secondary|Physician's Global Assessment of Disease Activity|"Physician's Global Assessment of Disease Activity was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). Baseline was defined as the original baseline score from assessment performed in Study ML19070. Physicians were to assess the disease activity on a 100-mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as no disease activity (symptom-free and no arthritis symptoms) and the right hand extreme (100 mm) as maximum disease activity (maximum arthritis disease activity)."|Baseline and Week 24|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||mm||Standard Deviation|Mean
744580|NCT00502840|Secondary|Tender Joint Count|Mean sum of 28 tender joints was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The 28 joints to be assessed for tenderness were shoulder, elbow, wrist, MCP joints 1-5, PIP joints 1-5, and knee on both sides of the body. The sum of tender joints ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status.|Screening and Week 24|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||tender joints||Standard Deviation|Mean
744581|NCT00502840|Secondary|Swollen Joint Count|Mean sum of 28 swollen joints was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The 28 joints to be assessed for swelling were shoulder, elbow, wrist, metacarpophalangeal (MCP) joints 1-5, proximal interphalangeal (PIP) joints 1-5, and knee on both sides of the body. The sum of swollen joints ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status.|Screening and Week 24|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||swollen joints||Standard Deviation|Mean
744582|NCT00502840|Secondary|Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Percent (%), 50%, or 70% Improvement (ACR20/ACR50/ACR70) by Treatment Course|ACR response was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). ACR20/50/70 response: ≥20/50/70%, respectively, improvement in SJC or TJC and 20/50/70% improvement in 3 of the following 5 criteria: 1) Physician's Global Assessment of Disease Activity, 2) Patient's Global Assessment of Disease Activity, 3) Patient's Assessment of Pain, 4) participants assessment of functional disability via HAQ-DI, and 5) C-reactive protein (CRP) or ESR at each visit.|24 weeks after each course|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
744583|NCT00502840|Secondary|SF-36 Domain Scores by Treatment Course - General Heath Perceptions|SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and MCS. The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.|Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||scores on a scale||Standard Deviation|Mean
744584|NCT00502840|Secondary|SF-36 Domain Scores by Treatment Course - Vitality|SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and MCS. The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.|Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||scores on a scale||Standard Deviation|Mean
744585|NCT00502840|Secondary|SF-36 Domain Scores by Treatment Course - Social Functioning|SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and MCS. The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.|Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||scores on a scale||Standard Deviation|Mean
744704|NCT00503984|Secondary|Number of Participants Experiencing Adverse Events After Beginning Protocol Therapy.||Up to 4.5 years|All study participants who received at least one dose of combination Azacitidine + Docetaxel, and 5 mg of Prednisone in either Phase 1 or Phase 2.||participants|||Number
744586|NCT00502840|Secondary|SF-36 Domain Scores by Treatment Course - Emotional Well-Being|SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and MCS. The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.|Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||scores on a scale||Standard Deviation|Mean
744587|NCT00502840|Secondary|SF-36 Domain Scores by Treatment Course - Emotional Role Functioning|SF-36was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the physical and mental composite t-scores (PCS and MCS). The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.|Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||scores on a scale||Standard Deviation|Mean
744588|NCT00502840|Secondary|SF-36 Domain Scores by Treatment Course - Physical Role Functioning|SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the physical and mental composite t-scores (PCS and MCS). The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.|Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||scores on a scale||Standard Deviation|Mean
744589|NCT00502840|Secondary|SF-36 Domain Scores by Treatment Course - Bodily Pain|SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and MCS. The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.|Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||scores on a scale||Standard Deviation|Mean
744590|NCT00502840|Secondary|SF-36 Domain Scores by Treatment Course - Physical Functioning|SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and MCS. The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.|Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||scores on a scale||Standard Deviation|Mean
744591|NCT00502840|Secondary|SF-36 MCS by Treatment Course|SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and MCS. The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.|Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||scores on a scale||Standard Deviation|Mean
744614|NCT00502853|Secondary|Health Assessment Questionnaire - Disability Index (HAQ-DI) Score|The Stanford HAQ-DI is a participant-reported questionnaire specific for rheumatoid arthritis (RA). It consist of 20 items referring to eight component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Each item within a domain was scored on a 4-point Likert scale from 0 to 3: 0 = no difficulty; 1 = some difficulty; 2 = much difficulty; 3 = unable to do. The highest score reported by the participant for a domain determined the score for that domain. The overall disability index is computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline and Weeks 4, 12, and 24|Safety Population||units on a scale||Standard Deviation|Mean
744592|NCT00502840|Secondary|Short-Form 36 (SF-36) Physical Composite Scores (PCS) by Treatment Course|SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and mental composite t-score (MCS). The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.|Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||scores on a scale||Standard Deviation|Mean
744593|NCT00502840|Secondary|Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score by Treatment Course|FACIT-F was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The FACIT fatigue scale is based on a 13-item questionnaire to assess the therapy-induced fatigue. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant’s response to the questions (with the exception of 2 negatively stated), greater was the participant’s fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant’s response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (best) to 52 (worst). The assessment was originally developed for chronic illnesses and is now validated for patients with rheumatoid arthritis (RA). The questionnaire was provided in a German translation.|Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||scores on a scale||Standard Deviation|Mean
744594|NCT00502840|Secondary|Health Assessment Questionnaire - Disability Index (HAQ-DI) Score by Treatment Course|HAQ-DI was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The HAQ-DI score consists of questions referring to 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. For each of the categories, participants reported the amount of difficulty they had in performing 2 or 3 specific sub-category items. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. The standard disability score was calculated from the 8 categories by dividing the sum of the individual categories by the number of categories answered ;total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. The questionnaire was provided in a German translation and was scored based on the instructions from the Stanford University Medical Center.|Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||scores on a scale||Standard Deviation|Mean
744595|NCT00502840|Secondary|Percentage of Participants Achieving a Response By EULAR Category and Treatment Course|Response was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders had a change from baseline >1.2 with a DAS28 score ≤3.2; moderate responders had a change from baseline >1.2 with a DAS28 score >3.2 to ≤5.1 or a change from baseline >0.6 to ≤1.2 with a DAS28 score ≤5.1; non-responders had a change from baseline ≤0.6 or change from baseline >0.6 and ≤1.2 with a DAS28 score > 5.1.|Week 24|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
744596|NCT00502840|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Response of 'Good' or 'Moderate' by Treatment Course|DAS28 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders had a change from baseline >1.2 with a DAS28 score ≤3.2; moderate responders had a change from baseline >1.2 with a DAS28 score >3.2 to ≤5.1 or a change from baseline >0.6 to ≤1.2 with a DAS28 score ≤5.1.|Week 24|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
744597|NCT00502840|Secondary|DAS28 Score by Treatment Course and Follow-up (FU) Visit|DAS28 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The DAS28 consists of SJC and TJC measurements, the ESR (measured in mm/hr), and Patient Global Asessment of disease activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 less than or equal to (≤)3.2 equals (=) low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12|ITT Population; n (number) = number of participants assessed for the specified parameter at a given visit.||scores on a scale||Standard Deviation|Mean
744598|NCT00502840|Primary|Change From Baseline in DAS28 Score at Week 24|DAS28 calculated from the swollen joint count (SJC) and tender joint count (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and Patient Global Asessment of disease activity (participant- rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). A clinically meaningful improvement in DAS28 was defined as an improvement of 1.2 units.|Week 24|Intent-to-Treat (ITT) Population: all participants who signed the informed consent form, received at least 1 dose of study medication, and where the DAS28 was measured at least once under study medication.||scores on a scale||Standard Deviation|Mean
744599|NCT00502853|Secondary|X-Rays: Left Hand Total Score|Left hand total scores as measured by X-rays examining erosion and joint space narrowing. Total score was calculated as the sum of the erosion score and the joint space narrowing score and ranged from 0 (best possible outcome) to 180 (worst possible outcome).|Baseline and Week 24|Safety Population; only participants with values at both Baseline and Week 24 were included in the analysis.||units on a scale||Standard Deviation|Mean
744601|NCT00502853|Secondary|Joint Space Narrowing - Left Hand|Joint space narrowing and joint subluxation or luxation are combined in a single score with a range of 0 to 4. A normal joint space was scored 0. A score of 2 was allowed to a focal narrowing of the joint or to a joint space not sufficiently narrowed to be scored 2. The score of 1 was not to be used when the reader was unsure whether there was joint space narrowing. A generalized narrowing leaving more than 50% of the original joint space present was scored 2. A generalized narrowing leaving less than 50% of the original joint space present was scored 3, and a subluxation of a joint was also scored 3. A bony ankylosis or a complete luxation of the joint was scored 4. A total of 13 joints were evaluated for narrowing and the scores were summed (13 x 4 [maximum per joint]). Each sum was normalized to a scale of 0 (best possible outcome) to 100 (worst possible outcome).|Baseline and Week 24|Safety Population; only participants with values at both Baseline and Week 24 were included in the analysis.||units on a scale||Standard Deviation|Mean
744602|NCT00502853|Secondary|Joint Space Narrowing - Right Hand|Joint space narrowing and joint subluxation or luxation are combined in a single score with a range of 0 to 4. A normal joint space was scored 0. A score of 2 was allowed to a focal narrowing of the joint or to a joint space not sufficiently narrowed to be scored 2. The score of 1 was not to be used when the reader was unsure whether there was joint space narrowing. A generalized narrowing leaving more than 50% of the original joint space present was scored 2. A generalized narrowing leaving less than 50% of the original joint space present was scored 3, and a subluxation of a joint was also scored 3. A bony ankylosis or a complete luxation of the joint was scored 4. A total of 13 joints were evaluated for narrowing and the scores were summed (13 times [x] 4 [maximum per joint]). Each sum was normalized to a scale of 0 (best possible outcome) to 100 (worst possible outcome).|Baseline and Week 24|Safety Population; only participants with values at both Baseline and Week 24 were included in the analysis.||units on a scale||Standard Deviation|Mean
744603|NCT00502853|Secondary|Erosion Score - Left Hand|The erosion score per joint of the hands can range from 0 to 5. Erosions were scored 1 if they were discrete but clearly present, and 2 or 3 if they were larger, depending on the surface area of the joint involved. A score of 3 was given if the erosion was large and extended over the imaginary middle of the bone. A score of 5 was given if a complete collapse of the joint was present or if the full surface of the joint was affected. In each joint, individual erosions were summed up to a maximum of 5. The maximal erosion score for each hand was thus 80, considering the 16 areas for erosions per hand.|Baseline and Week 24|Safety Population; n=number of participants with values for analysis at the specified timepoints.||units on a scale||Standard Deviation|Mean
744604|NCT00502853|Secondary|Erosion Score - Right Hand|The erosion score per joint of the hands can range from 0 to 5. Erosions were scored 1 if they were discrete but clearly present, and 2 or 3 if they were larger, depending on the surface area of the joint involved. A score of 3 was given if the erosion was large and extended over the imaginary middle of the bone. A score of 5 was given if a complete collapse of the joint was present or if the full surface of the joint was affected. In each joint, individual erosions were summed up to a maximum of 5. The maximal erosion score for each hand was thus 80, considering the 16 areas for erosions per hand.|Baseline and Week 24|Safety Population||units on a scale||Standard Deviation|Mean
744605|NCT00502853|Secondary|Percentage of Total B-lymphocytes|Concentration of all B-lymphocytes subtypes was assessed.|Baseline and Weeks 4, 12, and 24|Safety Population||percentage of cells||Standard Deviation|Mean
744606|NCT00502853|Secondary|Hematocrit Concentration (%)||Baseline and Weeks 4, 12, and 24|Safety Population||percentage||Standard Deviation|Mean
744607|NCT00502853|Secondary|Total Immunoglobulin (Ig) Concentrations|Total Ig concentrations as measured by milligrams per milliliter (mg/mL).|Baseline and Weeks 4, 12, and 24|Safety Population||mg/mL||Standard Deviation|Mean
744608|NCT00502853|Secondary|Rheumatoid Factor (RF) Immunoglobulin M (IgM) Concentrations|RF IgM concentrations measured by international units per milliliter (IU/mL). RF is an antibody reacting against the fragment, crystallizable (Fc) region of IgG. Quantitative measurements have shown a prognostic value in distinguishing between progressive and non-progressive disease in early RA, a correlation with radiologically determined joint damage, and relation with clinical improvement after disease-modifying anti-rheumatic treatment.|Baseline and Weeks 4, 12, and 24|Safety Population||IU/mL||Standard Deviation|Mean
744609|NCT00502853|Secondary|Anti-Cyclic Citrullinated Peptide (Anti-CCP) Autoantibodies Count|Anti-CCP autoantibodies count measured by units per milliliter (U/mL). The anti-CCP autoantibodies bind antigenic determinants that contain the unusual amino acid citrulline. The anti-CCP antibody is a highly specific diagnostic test of RA (though with variable sensitivity) and a marker of joint damage with high prognostic significance.|Baseline and Weeks 4, 12, and 24|Safety Population||U/mL||Standard Deviation|Mean
744610|NCT00502853|Secondary|C-Reactive Protein (CRP)|CRP measured by milligrams per deciliter (mg/dL). High levels of CRP are indicators of active inflammation.|Baseline and Weeks 4, 12, and 24|Safety Population||mg/dL||Standard Deviation|Mean
744611|NCT00502853|Secondary|Erythrocyte Sedimentation Rate (ESR)|ESR was determined using the Westergren method. ESR measures how fast red blood cells (erythrocytes) fall to the bottom of a fine glass tube that is filled with the participant's blood. The higher the sedimentation rate the greater the inflammation.|Baseline and Weeks 4, 12, and 24|Safety Population||mm/hr||Standard Deviation|Mean
744612|NCT00502853|Secondary|DAS28 Score|DAS28 calculated from the number of swollen joints and tender joints using the 28-joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. A DAS28 score of less than or equal to (≤) 3.2 = low disease activity, a DAS28 score of >3.2 to 5.1 = moderate to high disease activity.|Baseline and Weeks 4, 12, and 24|Safety Population||units on a scale||Standard Deviation|Mean
744613|NCT00502853|Secondary|Patient’s Global Assessment of Pain|The participant’s assessment of their current level of pain on a 0 to 100 millimeter (mm) horizontal VAS. The left-hand extreme of the line was described as “no pain” and the right-hand as “unbearable pain”. The participant was asked to mark the line corresponding to their current level of pain and the distance from the left edge was recorded.|Baseline and Weeks 4, 12, and 24|Safety Population||mm||Standard Deviation|Mean
744626|NCT00502996|Secondary|Mean Value of Inflamed Joints|The efficacy of rituximab was assessed by evaluating inflamed joints.|Screening (Days -28 to 0), EOT (Week 24), and EOFU (Week 48)|All eligible participants who received one treatment dose of rituximab were considered for this outcome measure.||number of inflamed joints||Standard Deviation|Mean
744615|NCT00502853|Primary|Relative Enhancement (RE) Score|A low cost, low field dedicated extremity MRI unit was used, which is specifically designed for the examination of peripheral joints. In addition to the standard OMERACT-RAMRIS scoring system, additional data were elaborated by using “dynamic” MRI (DCE-MRI). This method evaluates the diffusion of the contrast mean in a series of very short sequences thus providing a diffusion curve which is proportionate to the extent of inflammation in the synovial membrane. Numerical parameters used with this method are the slope in the initial phase (REE) and its “steady state” condition (RE).|Baseline, Weeks 4 and 24|Safety Population||percent||Standard Deviation|Mean
744616|NCT00502853|Primary|Early Enhancement Rate (REE)|A low cost, low field dedicated extremity MRI unit was used, which is specifically designed for the examination of peripheral joints. In addition to the standard OMERACT-RAMRIS scoring system, additional data were elaborated by using “dynamic” MRI, i.e. Contrast-Enhanced Dynamic MRI (DCE-MRI). This method evaluates the diffusion of the contrast mean in a series of very short sequences thus providing a diffusion curve which is proportionate to the extent of inflammation in the synovial membrane. Numerical parameters used with this method are the slope in the initial phase (rate of early enhancement - REE) and its “steady state” condition (relative enhancement - RE). REE per second during the first 55 seconds was calculated according to the formula REE55 = (S55-S0)/(S0x55)x100%. The REE shows the slope of the curve of contrast uptake tangential to the α angle and is steeper if inflammation is higher.|Baseline, Weeks 4 and 24|Safety Population||percent per second||Standard Deviation|Mean
744617|NCT00502853|Secondary|Ritchie Articular Index Scores|The Ritchie Articular Index is a graded assessment of tenderness in 26 joint regions. The sum of the grades of tenderness (0=not tender, 1=tender, 2=tender and causes wince, and 3 tender, causes wince and effort to withdraw) elicited by applying firm pressure over the joint margin of articular joints (such as shoulders, elbow, wrists, hips). The scores ranged from 0 (no tenderness) to 78 (most severe tenderness).|Baseline and Weeks 4, 12, and 24|Safety Population||units on a scale||Standard Deviation|Mean
744618|NCT00502853|Primary|OMERACT RAMRIS Erosion Score|MRI bone erosion measures a sharply marginated bone lesion, with correct juxta-articular localization and typical signal characteristics, which is visible in 2 planes with a cortical break seen in at least 1 plane. Each bone (wrists: carpal bones, distal radius, distal ulna, metacarpal bases; MCP joints: metacarpal heads, phalangeal bases) scored separately. Scale is 0–10 based on proportion of eroded bone compared to assessed bone volume (0=no erosion; 1=1%–10% of bone eroded; 2=11%–20%, etc). For long bones, assessed bone volume is from articular surface (or best estimated position if absent) to depth of 1 centimeter (cm); in carpal bones it is the whole bone. Total erosion score=sum of individual scores for an overall range of 0–230, where 0=no erosion and 230=most severe erosion. Change in erosion=Follow-up erosion score - baseline score.|Baseline, Week 4, and Week 24|Safety Population||units on a scale||Standard Deviation|Mean
744619|NCT00502853|Primary|OMERACT RAMRIS Bone Edema Score|Extension and degree of bone edema in the wrist according to the RAMRIS score developed by OMERACT. Bone edema is a lesion within the trabecular bone, with ill-defined margins and signal characteristics consistent with increased water content. Each bone (wrists: carpal bones, distal radius, distal ulna, metacarpal bases; MCP joints: metacarpal heads, phalangeal bases) is scored separately. The scale of 0–3 was based on the proportion of bone with edema, as follows: 0=no edema; 1=1 percent (%) to 33% of bone was edematous; 2 = 34%–66% of bone was edematous; and 3= 67%–100% of bone was edematous. Total bone edema score=sum of the individual scores for an overall range of 0–69, where 0=no edema and 69=most severe edema. Change in bone edema = follow-up bone edema score - baseline score.|Baseline, Weeks 4 and 24|Safety Population||units on a scale||Standard Deviation|Mean
744620|NCT00502853|Primary|Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Synovitis Score|Extension and degree of synovitis in wrist according to RAMRIS score developed by OMERACT. Synovitis is an area in synovial compartment that shows above normal post-gadolinium enhancement of a thickness greater than width of normal synovium. Synovitis is assessed in 3 wrist regions (distal radioulnar joint; radiocarpal joint; intercarpal and carpometacarpal joints) and in each metacarpophalangeal (MCP) joint. 1st carpometacarpal joint and 1st MCP joint are not scored. Score 0 is normal, and 1–3 (mild, moderate, severe) are by thirds of the presumed maximum volume of enhancing tissue in the synovial compartment. Total synovitis score=the sum of the individual scores (3 wrist regions [range 0-9] or 4 MCP joints [range 0-12]) for an overall range of 0–21, where 0=no damage and maximum score [9, 12, or 21]=most severe damage. Change in synovitis = Follow-up synovitis score - baseline score.|Baseline, Week 4, and Week 24|The Safety Population included all participants who received any portion of the rituximab dose and was used for efficacy and safety analyses.||units on a scale||Standard Deviation|Mean
744621|NCT00502905|Primary|Number of Participants With Successful Engraftment|Successful Engraftment defined as first of 3 consecutive days with Absolute neutrophil count (ANC) equal to or more than 0.5 * 10^9/L. Failure to engraft by day +30 considered primary engraftment failure. Study period one week prior to transplant through post Day 28.|Study period one week prior to transplant through post Day 28|Analysis per protocol.||participants|||Number
744622|NCT00502944|Primary|Linkage to Care of Newly Diagnosed HIV Infected Participants|We define linkage to care as attendance at a first HIV clinic appointment where the following 3 events occur: 1) introduction to an HIV care primary provider; 2) receipt of confirmatory Western Blot HIV test results; and 3) phlebotomy for CD4 cell count and HIV RNA level.|Assessed within 8 weeks after receipt of reactive rapid HIV test results|DSMB recommended the trial be ended early for likely inability to obtain this primary outcome. Thus the outcomes reported in paper are the secondary and other pre-specified outcomes listed.||participants|||Number
744623|NCT00502944|Other Pre-specified|Test Acceptance Rate|Acceptance of the HIV test was defined as the proportion of study participants who received the HIV test among those offered the test.|Assess on day subject enrolled into the study|Number of participants analyzed equals the number of participants offered a rapid HIV test. Many participants left the ED before the opportunity was available to offer the test.||participants|||Number
744624|NCT00502944|Other Pre-specified|Test Offer Rate|The offer rate of the HIV test was defined as the proportion of enrolled study participants who were actually offered a test.|Assess on day subject enrolled into the study|||participants|||Number
744625|NCT00502944|Secondary|Overall Rapid HIV Testing Rate|We defined the overall rapid HIV testing rate as the number of participants tested for HIV using the rapid test among those randomized to potentially be tested in each arm.|Assess on day subject enrolled into the study|Intention to treat analysis||participants|||Number
744627|NCT00502996|Secondary|Mean Values of Pain and Activity Based on Visual Analogue Scale|Pain assessment was assessed by using a VAS (0=no pain to 100=unbearable pain). Disease activity was also evaluated by participants and investigators by using a VAS (0=no disease activity to 100=maximum disease activity).|Screening ((Days -28 to 0), Week 1, Week 12, and Week 24|All eligible participants who received one treatment dose of rituximab were considered for this outcome measure.||Scores on scale||Standard Deviation|Mean
744628|NCT00502996|Secondary|Mean Values of Globular Sedimentation Velocity|Globular sedimentation velocity is a component of ACR.|Screening ((Days -28 to 0), Week 1, Week 12, and Week 24|All eligible participants who received one treatment dose of rituximab were considered for this outcome measure.||millimeters per hour||Standard Deviation|Mean
744629|NCT00502996|Secondary|Mean Values of C Reactive Protein|C Reactive Protein (CRP) is a component of ACR. CRP is a marker of inflammation.|Screening ((Days -28 to 0), EOT (Week 24), and EOFU (Week 48)|All eligible participants who received one treatment dose of rituximab were considered for this outcome measure.||milligrams per liter||Standard Deviation|Mean
744630|NCT00502996|Secondary|Mean Value of Quality of Life (Health Assessment Questionnaire – Disease Index)|Health Assessment Questionnaire - Disease Index (HAQ-DI) indicates how the disease affected participant’s activities of daily life. It consisted of 20 questions in 8 domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities) rated on a 4-point scale, 0=without any difficulty to 3=unable to do. Sum of scores was divided by number of domains with a score for a total possible score of 0 (best/no difficulties to perform activities) to 3 (worst/ unable to perform activities at all).|Screening (Days -28 to 0), Week 1, Week 12, and Week 24|All eligible participants who received one treatment dose of rituximab were considered for this outcome measure.||Scores on scale||Standard Deviation|Mean
744631|NCT00502996|Secondary|Number of Participants With American College of Rheumatology (20, 50, and 70) Criteria|American College of Rheumatology (ACR) criteria improvement consisting of 20%, 50%, and 70% (ACR20, ACR50, and ACR70, respectively) reduction in tender joints and swollen joints, as well as for three of the additional five ACR core set variables: patient’s assessment of pain using a Visual Analog Scale (VAS) with left end of the line 0=no pain to right end of the line 100=unbearable pain); patient’s global assessment of disease activity and physician’s global assessment of disease activity using a VAS (0=no disease activity to 100=maximum disease activity); health assessment questionnaire (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant; C-reactive protein and globular sedimentation velocity.|Week 1, Week 12, and Week 24|All eligible participants who received one treatment dose of rituximab were considered for this outcome measure.||participants|||Number
744632|NCT00502996|Secondary|Mean Value of Painful Joints|The efficacy of rituximab was assessed by evaluating painful joints.|Screening (Days -28 to 0), EOT (Week 24), and EOFU (Week 48)|All eligible participants who received one treatment dose of rituximab were considered for this outcome measure.||number of painful joints||Standard Deviation|Mean
744633|NCT00502996|Secondary|Mean Duration of Morning Joint Stiffness|The efficacy of rituximab was assessed by evaluating mean duration of morning joint stiffness.|Screening ((Days -28 to 0), EOT (Week 24), and EOFU (Week 48)|All eligible participants who received one treatment dose of rituximab were considered for this outcome measure.||Minutes||Standard Deviation|Mean
744634|NCT00502996|Secondary|Mean Values of Aspartate Transaminase, Alanine Transaminase, Alkaline Phosphatase, and Lactic Dehydrogenase at Screening and EOT Visit|The mean aspartate transaminase (AST) and alanine transaminase (ALT), Alkaline phosphatase (AP), and Lactic dehydrogenase (LDH) concentration for each participant was estimated at Screening and at EOT visit.|Screening (Days -28 to 0) and EOT (Week 24)|The safety population included all eligible participants who received one treatment dose of rituximab and have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.||International units/liter||Standard Deviation|Mean
744635|NCT00502996|Secondary|Mean Values of Potassium, Chlorine, Sodium, and Phosphorus at Screening and EOT Visit|The mean concentration of potassium, chlorine, sodium and phosphorus for each participant was estimated at Screening and at EOT.|Screening (Days -28 to 0) and EOT (Week 24)|The safety population included all eligible participants who received one treatment dose of rituximab and have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.||millimoles per liter||Standard Deviation|Mean
744636|NCT00502996|Secondary|Mean Values of Cholesterol, Uric Acid, Urea, Creatinine, Calcium, Total Bilirubin and Serum Total Proteins at Screening and EOT Visit.|The mean concentration of cholesterol, uric acid, urea, creatinine, calcium, total bilirubin and serum total proteins (STP) for each participant was estimated at Screening and at EOT visit.|Screening (Days -28 to 0) and EOT (Week 24)|The safety population included all eligible participants who received one treatment dose of rituximab and have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.||mg/dL||Standard Deviation|Mean
744637|NCT00502996|Secondary|Mean Values of Biochemistry Parameters at Screening and Visit 8 (Albumin and Glucose)|The mean albumin and glucose concentration for each participant was estimated at Screening and at EOT visit.|Screening (Days -28 to 0) and EOT (Week 24)|The safety population included all eligible participants who received one treatment dose of rituximab and have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.||g/dL||Standard Deviation|Mean
744638|NCT00502996|Secondary|Mean Values of Hematology Parameters at Screening and EOT Visit (Leucocytes and Platelets)|The mean leucocytes and platelets concentration for each participant was estimated at Screening, at EOT visit.|Screening (Days -28 to 0) and EOT (Week 24)|The safety population included all eligible participants who received one treatment dose of rituximab and have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.||10^9 cells/liter||Standard Deviation|Mean
744639|NCT00502996|Secondary|Mean Values of Hematology Parameter at Screening and EOT Visit (Erythrocytes)|The mean erythrocyte concentration for each participant was estimated at Screening and at EOT.|Screening (Days -28 to 0) and EOT (Week 24)|The safety population included all eligible participants who received one treatment dose of rituximab and have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.||10^12 cells/liter||Standard Deviation|Mean
744651|NCT00503113|Secondary|Relative Change From Baseline in Urine Albumin-to-Creatinine Ratio.|The relative change from baseline in this case is positively skewed (while the absolute change is not) and the means tends to more positive values.|Baseline and 9 months|PP Population||mg/g||Standard Deviation|Mean
744640|NCT00502996|Secondary|Mean Values of Hematology Parameter at Screening and EOT Visit (Mean Corpuscular Volume)|Mean corpuscular volume (MCV) is the average volume of red cells. The mean MCV concentration for each participant was estimated at Screening and EOT.|Screening (Days -28 to 0) and EOT (Week 24)|The analysis was performed on safety population. Eligible participants who received one treatment dose of Rituximab, have completed the follow-up period, Visit 11, and end of follow-up period in safety conditions and also who had been withdrawn or not from the study were included in the safety population.||femtoliters||Standard Deviation|Mean
744641|NCT00502996|Secondary|Mean Values of Hematology Parameters at Screening and EOT Visit (Hematocrit, Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils)|The hematology parameters (hematocrit, neutrophils, lymphocytes, monocytes, eosinophils, and basophils) for each participant were estimated at Screening and at EOT.|Screening (Days -28 to 0) and EOT (Week 24)|The safety population included all eligible participants who received one treatment dose of rituximab and have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.||percentage of cells||Standard Deviation|Mean
744642|NCT00502996|Secondary|Mean Values of Hematology Parameters at Screening and EOT Visit (Hemoglobin and Mean Corpuscular Hemoglobin Concentration)|The values of hemoglobin (Hb) and mean corpuscular hemoglobin concentration (MCHC) for each participant were estimated at Screening and at EOT visit.|Screening (Days -28 to 0) and EOT (Week 24)|The safety population included all eligible participants who received one treatment dose of rituximab and have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.||g/deciliter (dL)||Standard Deviation|Mean
744643|NCT00502996|Primary|Number of Participants With AEs of Special Interest During the Study|Adverse event of special interest during the study treatment and follow up period included infections. The participants with AEs of special interest were reported at Screening, End of treatment (EOT), and End of Follow-up (EOFU) visit.|Screening (Days -28 to 0), EOT (Week 24), and EOFU (Week 48)|The safety population included all eligible participants who received one treatment dose of rituximab and have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.||participants|||Number
744644|NCT00502996|Primary|Number of Participants With AEs Leading to Discontinuation and Any Drug Related AEs and SAEs|"An AE is any unfavorable sign and non-intentional, symptom or disease temporarily related with the use of a medicinal product, considered or not related to the medicinal product. Pre-existing conditions that worsened during the study were reported as AEs. A SAE is any experience that suggested a significant risk, contraindication, caution, and at any dose, fulfills, at least, one of the following criteria: adverse event considered as fatal (resulting in death), life threatening, defect of birth/congenital abnormality, required hospitalization or extension of hospital length of stay, significant medical intervention, resulted in significant disability/impairment. Relationship between AEs and medication under investigation was evaluated through the classification Yes and No. A relationship classified as Yes implied a significant causal relationship with the medication under investigation which was evaluated based on enough evidences, facts or arguments."|Up to Week 48|The safety population included all eligible participants who received one treatment dose of rituximab and have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.||participants|||Number
744645|NCT00502996|Primary|Number of Participants With AEs According to Degree of Intensity|An AE is any unfavorable sign and non-intentional, symptom or disease temporarily related with the use of a medicinal product, considered or not related to the medicinal product. Pre-existing conditions that worsened during the study were reported as AEs. The Intensity of AEs was classified as Grade 1, Grade 2, Grade 3 and Grade 4. Grade 1: Discomfort was noticed, but the normal daily activity was not interrupted. Grade 2: Discomfort was enough to reduce the normal daily activity. Grade 3: There was disability for work or develop normal daily activities. Grade 4: It represented an immediate threat to life (these events were reported as SAEs).|Up to Week 48|The safety population included all eligible participants who received one treatment dose of rituximab and have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.||participants|||Number
744646|NCT00502996|Primary|Number of Participants With Any Adverse Event, Any Serious Adverse Event, and Death|An Adverse event (AE) was considered any unfavorable medical event in a participant of clinical research who received the study drug and that not necessarily had a causal relationship with this treatment. An AE could, therefore, being any unfavorable sign and non-intentional, symptom or disease temporarily related with the use of a medicinal product, considered or not related to the medicinal product. Pre-existing conditions that worsened during the study were reported as AEs. A serious adverse event (SAE) is any experience that suggested a significant risk, contraindication, caution, and at any dose fulfills at least one of the following criteria: adverse event considered as fatal (resulting in death), life threatening, defect of birth/congenital abnormality, required hospitalization or extension of hospital length of stay, significant medical intervention, resulted in significant disability/impairment.|Up to Week 48|The safety population included all eligible participants who received one treatment dose of rituximab and have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.||participants|||Number
744647|NCT00503009|Secondary|Change From Baseline in Exhaled Nitric Oxide (eNO) Averaged Over Days 1-4|eNO was measured using a study-issued monitor. Due to the small sample size, efficacy measures were not analyzed.|Days 1 through 4||||||
744648|NCT00503009|Secondary|Change From Baseline in the Morning Forced Expiratory Volume in One Second (FEV1) Averaged Over Days 1-4|FEV1 measurements were collected via a study-issued spirometer. Due to the small sample size, efficacy measures were not analyzed.|Days 1 through 4||||||
744649|NCT00503009|Secondary|Change From Baseline in the Morning Peak Expiratory Flow (PEF) Averaged Over Days 1-4|PEF measurements were collected via a study-issued electronic peak flow meter. Due to the small sample size, efficacy measures were not analyzed.|Days 1 through 4||||||
744650|NCT00503009|Primary|Change From Baseline in the Cumulative Lower Respiratory Symptom Score Averaged Over Days 1-4|The cumulative lower respiratory symptom score consisted of the summary of individual scores assessing cough, shortness of breath, chest discomfort, and wheezing based on the following scale: 0 (not present); 1=mild, clearly present; 2=moderately severe, uncomfortable; 3=severe (best possible score of 12; worst possible score of 0), interfering with sleep or activity. Due to the small sample size, efficacy measures were not analyzed.|Days 1 through 4||||||
744652|NCT00503113|Secondary|Absolute Change From Baseline in Urine Albumin-to-Creatinine Ratio.||Baseline and 9 months|PP Population||mg/g||Standard Deviation|Mean
744659|NCT00503139|Secondary|European League Against Rheumatism (EULAR) Disease Activity Score (DAS) 28 Improvement (3/Erythrocyte Sedimentation Rate: ESR)|DAS28-3 (ESR) was calculated from swollen joint count (SJC) and tender joint count (TJC) using 28 joints count and ESR (mm/hour). Total score range: 0-9.4, higher score=more disease activity. DAS28-3 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (ESR) <2.6 = remission.|2 years|The efficacy analysis population (N = number of participants evaluated) consisted of the participants in whom DAS28 (3/ESR) was calculated. The last observation carried forward (LOCF) method was used to impute missing data.||percentage of participants||95% Confidence Interval|Number
744660|NCT00503139|Secondary|Visual Analog Fatigue Scale (VAFS)|Participants assessed their fatigue using a 0 - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue.|2 years|The efficacy analysis population (N = number of participants evaluated) consisted of the participants in whom VAS Fatigue was calculated. The last observation carried forward (LOCF) method was used to impute missing data.||Score||Standard Deviation|Mean
744661|NCT00503139|Secondary|Modified Health Assessment Questionnaire (mHAQ) Score|Modified Health Assessment Questionnaire-(mHAQ): participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|2 years|The efficacy analysis population (N = number of participants evaluated) consisted of the participants in whom mHAQ was calculated. The last observation carried forward (LOCF) method was used to impute missing data.||Score||Standard Deviation|Mean
744662|NCT00503139|Primary|European League Against Rheumatism (EULAR) Disease Activity Score (DAS) 28 Improvement (4/Erythrocyte Sedimentation Rate: ESR)|DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = remission.|2 years|The efficacy analysis population (N = number of participants evaluated) consisted of the participants in whom DAS28 (4/ESR) was calculated. The last observation carried forward (LOCF) method was used to impute missing data.||percentage of participants||95% Confidence Interval|Number
744663|NCT00503139|Primary|Number of Participants With Unlisted Treatment Related Adverse Events of Etanercept|Adverse events are all unfavorable events, including clinically problematic abnormal changes in laboratory test values, which develop in participants after the administration of Etanercept, irrespective of causal relationship to Etanercept. The causal relationship between an adverse event and Etanercept was evaluated by the sponsor. Unlisted treatment related adverse events were confirmed with listed adverse drug reactions specified in Japanese package insert.|3 years|The safety analysis population (N = number of participants evaluated) consisted of the participants who received etanercept for rheumatoid arthritis because of an inadequate response to the conventional therapies and had no history of or concurrent malignant tumors.||Participants|||Number
744664|NCT00503139|Primary|Number of Participants With Serious Treatment Related Adverse Events of Etanercept|Serious treatment-related adverse events are defined as any events that lead to death, life-threatening, hospitalization or prolonged hospitalization, a permanent or remarkable disorder/dysfunction, congenital anomaly/congenital deficiency, or other medically significant events or disorder.|3 years|The safety analysis population (N = number of participants evaluated) consisted of the participants who received etanercept for rheumatoid arthritis because of an inadequate response to the conventional therapies and had no history of or concurrent malignant tumors.||Participants|||Number
744665|NCT00503139|Primary|Number of Participants With Treatment Related Adverse Events of Etanercept|Adverse events are all unfavorable events, including clinically problematic abnormal changes in laboratory test values, which develop in participants after the administration of Etanercept, irrespective of causal relationship to Etanercept. The causal relationship between an adverse event and Etanercept was evaluated by the sponsor.|3 years|The safety analysis population (N = number of participants evaluated) consisted of the participants who received etanercept for rheumatoid arthritis because of an inadequate response to the conventional therapies and had no history of or concurrent malignant tumors.||Participants|||Number
744666|NCT00503139|Primary|Number of Participants in Safety Analysis Population of Etanercept||3 years|The safety analysis population (N = number of participants evaluated) consisted of the participants who received etanercept for rheumatoid arthritis because of an inadequate response to the conventional therapies and had no history of or concurrent malignant tumors.||Participants|||Number
744667|NCT00503308|Primary|Satisfaction With HIV Testing Experience (O'Connor Decisional Conflict Scale)|We measured decisional conflict, the primary outcome of the study, using the English or Spanish language 10-item Low Literacy Decisional Conflict Scale. We considered a DCS score of 25 or less to be low, corresponding to limited conflict. All questions have 3 response categories: yes, no, unsure. Items are scored as 0 = yes, 2 = unsure, 4 = no. Scores for each of the 10 items are summed, divided by 2 and multiplied by 25 to calculate the total score. The final scores range from 0(no decisional conflict) to 100 (extremely high decisional conflict).|same day as HIV test counseling (cross-sectional study)|||scores on scale||95% Confidence Interval|Mean
744668|NCT00503399|Secondary|Number of Participants With Adverse Events (AEs)|Summary tables of serious AEs (SAEs) and all other non-serious AEs are located in the Reported Adverse Event Module. Fractures that occurred during the study were collected separately as an additional safety variable. The number of participants experiencing hypercalcemia was summarized for each treatment arm. Hypercalcemia was defined as a serum calcium level corrected for albumin of >2.7 millimole per liter (mmol/L) (10.8 milligram per deciliter [mg/dL]).|Baseline up to 18 months|The safety analysis set included all participants who received study treatment.||participants|||Number
744669|NCT00503399|Secondary|Change From Baseline in Serum Type I Collagen Degradation Fragments (β-CTx) at 3 Months, 6 Months, and 18 Months|β-CTx was used as a biochemical marker of bone turnover/resorption, reflecting collagen breakdown of the bone matrix.|3, 6, 18 months|The analysis population was the full analysis set (FAS), which included all randomized participants who received at least 1 dose of study medication.||nanograms per deciliter (ng/dL)||Standard Error|Least Squares Mean
774280|NCT00746590|Secondary|Post-treatment Changes in the Amount of Contrast-enhancing and Non-contrast-enhancing Tumour||Every 6 weeks until progression||||||
744670|NCT00503399|Secondary|Change From Baseline in Serum Aminoterminal Propeptide of Type I Procollagen (P1NP) at 3 Months, 6 Months, and 18 Months|P1NP was used as a serum biochemical marker of collagen synthesis, reflecting the formation of new osteoid.|Baseline, 3 months, 6 months, 18 months|The analysis population was the full analysis set (FAS), which included all randomized participants who received at least 1 dose of study medication.||micrograms per deciliter (μg/dL)||Standard Error|Least Squares Mean
744671|NCT00503399|Secondary|Change From Baseline in Areal Bone Mineral Density (BMD) at Lumbar Spine, Femoral Neck, and Total Hip at 18 Months|Dual x-ray absorptiometry (DXA) techniques validated this measurement at skeletal sites that are at risk of osteoporotic fracture, such as lumbar spine, femoral neck, and hip.|Baseline, 18 months|The analysis population was the full analysis set (FAS), which included all randomized participants who received at least 1 dose of study medication.||grams per square centimeter (g/cm^2)||Standard Deviation|Mean
744672|NCT00503399|Secondary|Change From Baseline in Axial Compression by Finite Element Analysis in the 12th Thoracic Vertebra (T12) at 6 Months and 18 Months: Stiffness and Strength|Axial compression was measured using HR-QCT-based finite element analysis to determine stiffness and strength of T12. Stiffness evaluated the strength of the vertebral body, defined as the slope of the initial step of the force-displacement curve. Strength of the vertebral body was evaluated under compressive loading conditions using computer simulation. LS Means were adjusted for age, baseline P1NP, fracture less than 12 months before study start, duration of prior bisphosphonate use, screening glucocorticoid dose, and cumulative glucocorticoid dose before and during the trial.|Baseline, 6 months, 18 months|The analysis population was the full analysis set (FAS), which included all randomized participants who received at least 1 dose of study medication.||Newton per millimeter (N/mm)||Standard Error|Least Squares Mean
744673|NCT00503399|Secondary|Change From Baseline in Anterior Bending and Axial Torsion by Finite Element Analysis in the 12th Thoracic Vertebra (T12) at 6 Months and 18 Months: Stiffness and Strength|Anterior bending and axial torsion were measured using HR-QCT-based finite element analysis to determine stiffness and strength of T12. Stiffness evaluated strength of the vertebral body, defined as the slope of the initial step of the force-displacement curve. Strength of the vertebral body was evaluated under compressive loading conditions using computer simulation. LS Means were adjusted for age, baseline P1NP, fracture less than 12 months before study start, duration of prior bisphosphonate use, screening glucocorticoid dose, and cumulative glucocorticoid dose before and during the trial.|Baseline, 6 months, 18 months|The analysis population was the full analysis set (FAS), which included all randomized participants who received at least 1 dose of study medication.||Newton/millimeter/radian (N/mm/rad)||Standard Error|Least Squares Mean
744674|NCT00503399|Secondary|Change From Baseline in High Resolution Quantitative Computerized Technology (HR-QCT) of Integral and Trabecular Bone Mineral Density (BMD) of the 12th Thoracic Vertebra (T12) at 6 Months and 18 Months|Three-dimensional (3-D) microstructure variables of T12 were assessed by HR-QCT. In contrast with regular QCT that assessed 3 millimeter (mm) slide thickness, HR-QCT used segmentation of 1 single vertebra with approximately 100 consecutive slides reconstructed at 300-400 micrometer (µm) slice increments covering the complete vertebral body. Least Squares (LS) Means were adjusted for age, baseline P1NP, fracture less than 12 months before study start, duration of prior bisphosphonate use, screening glucocorticoid dose, and cumulative glucocorticoid dose before and during the trial.|Baseline, 6 months, 18 months|The analysis population was the full analysis set (FAS), which included all randomized participants who received at least 1 dose of study medication.||milligram per cubic centimeter (mg/cm^3)||Standard Error|Least Squares Mean
744675|NCT00503399|Secondary|Change From Baseline in Lumbar Spine Volumetric Trabecular Bone Mineral Density (BMD) by Quantitative Computerized Technology (QCT) at 6 Months|Least Squares (LS) Means were adjusted for age, baseline propeptide of Type I procollagen (P1NP), fracture less than 12 months before study start, duration of prior bisphosphonate use, screening glucocorticoid dose, and cumulative glucocorticoid dose before and during the trial.|Baseline, 6 months|The analysis population was the primary efficacy population, which included all randomized participants who received at least 1 dose of study medication (full analysis set) and had a lumbar spine volumetric trabecular BMD measurement at baseline and at ≥1 post-baseline visit.||milligram per cubic centimeter (mg/cm^3)||Standard Error|Least Squares Mean
744676|NCT00503399|Primary|Change From Baseline in Lumbar Spine Volumetric Trabecular Bone Mineral Density (BMD) by Quantitative Computerized Tomography (QCT) at 18 Months|Least Squares (LS) Means were adjusted for age, baseline serum aminoterminal propeptide of Type I procollagen (P1NP), fracture less than 12 months before study start, duration of prior bisphosphonate use, screening glucocorticoid dose, and cumulative glucocorticoid dose before and during the trial.|Baseline, 18 months|The analysis population was the primary efficacy population, which included all randomized participants who received at least 1 dose of study medication (full analysis set) and had a lumbar spine volumetric trabecular BMD measurement at baseline and at ≥1 post-baseline visit.||milligram per cubic centimeter (mg/cm^3)||Standard Error|Least Squares Mean
744677|NCT00503425|Secondary|Change From Baseline in Bone Density Score at Weeks 48 and 104|Bone density or bone mineral density (BMD) is the amount of bone mineral in bone tissue. BMD test results are compared to the ideal or peak BMD of a healthy 30-year-old adult, and results are provided as T-score. A score of 0 means BMD is equal to the norm for a healthy young adult. Differences between observed BMD and that of the healthy young adult norm are measured in units called standard deviations (SDs). The more standard deviations below 0, indicated as negative numbers, lower the BMD higher the risk of fracture. SD + 1 to -1 indicates normal BMD; SD between -1 to -2.5 indicates low bone mass, SD -2.5 or lower indicates osteoporosis. Change in bone density was measured in participants who were not treated with biphosphonates by Dual Energy X-Ray Absorptiometry. Change in bone density was assessed at baseline and at Weeks 48 and 104. Change from baseline in bone density score was reported for all 5 courses.|Baseline, Weeks 48 and 104 (End of treatment)|ITT population. Here, number of participants analyzed (N) signified those participants who were evaluable for this outcome and “n” signified participants with evaluable data for a specified time point.||T-score||Standard Deviation|Mean
744705|NCT00503984|Secondary|Overall Survival (OS)|The time from the date of initiation of study treatment until date of death from any cause.|Up to 4.5 years.|||months||95% Confidence Interval|Median
744706|NCT00503984|Secondary|Progression-Free Survival (PFS)|The time from the date of start of treatment until the first documented or confirmed disease progression, or death related to prostate cancer, whichever is earlier.|Up to 4.5 years|||months||95% Confidence Interval|Median
744678|NCT00503425|Secondary|Percentage of Participants With EULAR DAS 28 Response at Week 24|Clinical response was assessed according to EULAR categorical DAS28 response criteria, which defined clinically meaningful improvement at Week 24. EULAR response was based on change from baseline (COB) in DAS28 score and also on actual DAS28 score, at Week 24. DAS28 score= participant's disease activity calculated using TJC28, SJC28, PGH [VAS: 0=no disease activity to 100=maximum disease activity] and ESR. DAS28 was calculated by following formula: 0.56*√TJC+(0.28*√SJC)+(0.70*ln ESR)+(0.014*PGH). Total possible score=0-10, higher scores represented higher disease activity. Scores below 2.6: clinical remission, </=3.2: low disease activity, </=5.1: moderate disease activity, above 5.1: severe disease. EULAR Good response: DAS28</=3.2; COB<-1.2. Moderate response: DAS28</=3.2 or >3.2 to </=5.1 or >5.1; COB <-1.2 or <-0.6 to greater than or equal to (>/=)-1.2. No response: DAS28 </=3.2 or > 3.2 to </=5.1 or >5.1; COB <-0.6 to >/=-1.2 or >/=-0.6. EULAR response was reported for 5 courses.|Week 24|ITT Population. Here, number of participants analyzed (N) signified those participants who were evaluable for this outcome and “n” signified participants with evaluable data for a specified time point.||Percentage of participants|||Number
744679|NCT00503425|Secondary|Percentage of Participants Whose DAS28 Improved by Greater Than (>) 1.2 at Week 24|DAS28 score is a measure of participant's disease activity calculated using TJC28, SJC28, PGH [VAS: 0=no disease activity to 100=maximum disease activity] and ESR. DAS28 was calculated according to following formula: [0.56*√TJC] + [0.28*√SJC] + [0.70*ln ESR] + [0.014*PGH]. Total possible score of 0 to approximately 10, where higher scores represented higher disease activity. Scores below 2.6 indicated clinical remission, score of </= 3.2 indicated low disease activity, score of </= 5.1 indicated moderate disease activity, and scores above 5.1 indicated high or severe disease. Rituximab was administered as needed during episodes of inflammation for up to 5 courses. Change from baseline in DAS28 to Week 24 was reported for all 5 courses. Participants whose DAS28 score improved by 1.2 score were reported.|Week 24|ITT Population. Here, number of participants analyzed (N) signified those participants who were evaluable for this outcome and “n” signified participants with evaluable data for a specified time point.||Percentage of participants|||Number
744680|NCT00503425|Secondary|Mean Change From Baseline in Disease Activity Score Based on 28 Joints (DAS 28) at Week 24|DAS28 score is a measure of participant's disease activity calculated using tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], participant's global assessment of disease activity (PGH) [visual analog scale (VAS): 0=no disease activity to 100=maximum disease activity] and erythrocyte sedimentation rate (ESR). DAS28 was calculated according to following formula: 0.56 multiplied by (*) square root (√) of TJC] plus (+) [0.28*√SJC]+[0.70*the natural logarithm (ln) ESR]+[0.014*PGH]. Total possible score of 0 to approximately 10, where higher scores represented higher disease activity. Scores below 2.6 indicated clinical remission, score of less than or equals to (</=) 3.2 indicated low disease activity, score of </=5.1 indicated moderate disease activity, scores above 5.1 indicated high or severe disease. Rituximab was administered as needed during episodes of inflammation for up to 5 courses. Change from baseline in DAS28 to Week 24 was reported for all 5 courses.|Baseline, Week 24|ITT Population. Here, number of participants analyzed (N) signified those participants who were evaluable for this outcome and “n” signified participants with evaluable data for a specified time point.||Units on a scale||Standard Deviation|Mean
744681|NCT00503425|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants with non-serious AEs was exclusive of SAEs.|Baseline up to study withdrawal or follow-up (Approximately 104 weeks)|Safety population included all participants who had received any part of an infusion of study medication.||Participants|||Number
744682|NCT00503698|Secondary|Health Related Quality of Life Assessments|Summary from activity of daily living from the Rotterdam Symptom Checklist (RSCL) measuring activity from 1 (active) to 5 (inactive). The Edmonton Symptom Assessment System (ESAS), subjects assess their health in the last 24 hours on a scale from 1 (good health) to 3 (feeling poorly). The EQ-5D is a measure of subjects' health outcome from 0 (death) to 1 (full health). SF-36 (Short Form (36)) covering mental and physicial health is provided in a scale from 0-100 with higher scores indicating greater satisfaction.|week 0, trial termination|FAS (full analysis set) is all subjects exposed to at least one dose of trial drug. Observations from end of trial visit is substitute for week 104. Not all subjects provided 'quality of life' data.||scores on a scale||Standard Deviation|Mean
744683|NCT00503698|Secondary|Mortality - Two-year Mortality Rate||week 0, trial termination|No analysis was done since the trial was prematurely terminated before week 104 of the trial. Trial was terminated January 16th, 2009.|||||
744684|NCT00503698|Secondary|Morbidity - Number of Hospitalisations, in Addition to Normal Dialysis Procedures|The number of times that the patient was hospitalised in addition to hospitalisation for normal dialysis procedures measured from week 0 (randomisation) to the time the trial was terminated.|week 0, trial termination|FAS (full analysis set) is all subjects exposed to at least one dose of trial drug. Due to the early termination of this trial, observations from end of trial visit are substituted for week 104 visit (end of trial as per protocol).||hospitalisations||Standard Deviation|Mean
744685|NCT00503698|Secondary|Morbidity - Time From Randomisation to Next Cardiovascular Event (Defined as Composite of All-cause Mortality, Non-fatal Myocardial Infarction, Stroke, Cardiac Insufficiency and Other Thrombo-embolic Event)|Morbidity - time from week 0 to next cardiovascular event (composite of all-cause mortality and cardiovascular events defined as adjudicated medical event of special interest and categorised as myocardial infarctions, cardiac insufficiencies, strokes or other thrombo-embolic events). Statistical analysis is based on all available information from week 0 to trial termination. Summary data illustrates percentage (%) participants with events estimated using Kaplan-Meier. Summary data illustrates morbidity until 52 weeks, because very few subjects had trial time longer than 52 weeks.|week 0, trial termination|FAS (full analysis set) is all subjects exposed to at least one dose of trial drug. Due to the early termination of this trial, observations from end of trial visit are substituted for week 104 (end of trial per protocol).||percentage of participants|||Number
744742|NCT00509925|Secondary|Hormonal Assessment: Adiponectin|Adiponectin levels after each treatment period.|Week 14, week 30|The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint.||ng/ml||Standard Deviation|Mean
744686|NCT00503698|Primary|Mortality - Time to All-cause Death|Time to all-cause death. Statistical analysis is based on all available information from week 0 to trial termination. Summary data illustrates percentage (%) participants dead estimated using Kaplan-Meier. Summary data illustrates mortality until 52 weeks, because very few subjects had trial time longer than 52 weeks. Due to early trial termination, median trial time was 17.4 weeks.|week 0, trial termination|FAS (full analysis set) is all subjects exposed to at least one dose of trial drug. Due to the early termination of this trial, observations from end of trial visit are substituted for week 104 visit (end of trial as per protocol).||percentage of participants|||Number
744687|NCT00503750|Secondary|Number of Participants Who Had Complete Clinical Resposnse, Partial Response and Stable Disease.|"Complete clinical response (CCR): complete disappearance of all measurable malignant disease. No new malignant lesion, disease-related symptoms or evidence of non-evaluable disease.
Partial response (PR): Reduction by at least 50% of the sum of the products of the longest perpendicular diameters of all measurable lesions.
Stable disease (SD): For bidimensionally measurable disease, no decrease or <25% increase in the sum of the products of the longest perpendicular diameters of all measurable lesions."|clinic examination every 2 weeks, evaluated every 3 months for 2 years post-op|||participants|||Number
744688|NCT00503750|Primary|Number of Participants With Complete Pathologic Response.|"Pathologic complete response (pCR): Absence of invasive breast cancer in the breast (mastectomy or lumpectomy) specimen at the time of definitive surgery. Presence of in situ cancer alone will be considered a pCR.
Although clinical examination is the primary method of determining response, radiologic assessments (mammogram, ultrasound ± MRI) may be used to confirm response/non-response."|assess at 8 weeks|||participants|||Number
744689|NCT00503776|Secondary|Changes in the Frequency and Types of Dietary Intakes|Patients are asked to note their food intake in terms of amount and texture over the past 24 hours as measured by 24 hour dietary recalls.|at baseline, at 1 month, 3 months and 6 months post-chemoradiation|Due to loss of funding, sufficient data for analysis was not collected.|||||
744690|NCT00503776|Secondary|Changes in the Amount and Texture of Food Consumed|Patients are asked to note their food intake in terms of amount and texture over the past 24 hours as measured by 24-hour dietary recalls.|at baseline, at 1 month, 3 months and 6 months post-chemoradiation|Due to loss of funding, sufficient data for analysis was not collected.|||||
744691|NCT00503776|Secondary|Number of Patients With Oral Mucositis by Grade|Measured by Common Toxicity Criteria (CTC) v. 3.00 = no mucositis (minimum score), 1 = mild mucositis, 2 = moderate mucositis, 3 = severe mucositis, 4 = life-threatening, disabling mucositis, 5 = death (worst score).|6 months after concurrent chemotherapy and radiation|Participants available for 6-month follow-up oral examination. No 6-month follow-up data were available for the following numbers of patients: Arm 1A (1), Arm 1B (4), Arm 2A (3), Arm 2B (2).||participants|||Number
744692|NCT00503776|Secondary|Stimulated and Unstimulated Salivary Production|Unstimulated and stimulated salivary production, measured in mL/minute. Unstimulated salivary production is determined by expectoration of passively accumulated secretions accumulated in three 2-minute periods. Stimulated salivary production is determined by chewing paraffin wax with expectoration of passively accumulated secretions accumulated in three 2-minute periods.|6 months after concurrent chemotherapy and radiation|Patients who underwent salivary testing at 6 months. The following patients were not available at 6- months for testing for salivary production: Arm 1A (1), Arm 1B (4), Arm 2A (3), Arm 2B (2)||mL per minute||Standard Deviation|Mean
744693|NCT00503776|Primary|Number of Patients With Each Degree of Swallowing Dysfunction|Grade of swallowing dysfunction as measured by the modified barium swallow score: grade 1, normal; grade 2, within functional limits; grade 3, mild impairment; grade 4, mild to moderate impairment; grade 5, moderate impairment; grade 6, moderate to severe impairment; grade 7, severe impairment|6 months after concurrent chemotherapy and radiation|One patient (Arm 2B) did not undergo the 6-month study||participants|||Number
744694|NCT00503841|Secondary|Toxicity of a 15-day Regimen of Daily Oral Administration of Erlotinib Hydrochloride||At day -7, prior to surgery, and 1 week post-surgery||||||
744695|NCT00503841|Secondary|Effect of Erlotinib Hydrochloride on Tumor Cell Proliferation (Ki67) and Apoptosis (TUNEL)||Baseline and day 0||||||
744696|NCT00503841|Secondary|Effect of Erlotinib Hydrochloride on Expression of NF-κB and AR in Patients With ER-negative, EGFR-positive and IL-1a-positive Breast Cancer||Baseline and day 0||||||
744697|NCT00503841|Primary|Effect of Erlotinib Hydrochloride on Expression of IL-1a in Patients With ER- Negative, EGFR- Positive and (IL-)1a-positive Breast Cancer||Baseline and day 0|No participants received the study drug erlotinib hydrochloride.|||||
744698|NCT00503906|Post-Hoc|Rate of Overall Survival in Study Participants|Rate of overall survival in study participants. Overall survival will be measured from the date of enrollment to the date of death from any cause, or the date of last contact (censored observations.)|18 months|||percentage of participants||95% Confidence Interval|Median
744699|NCT00503906|Secondary|Relationship Between SPARC Expression and Response to Protocol Therapy.|Relationship between SPARC expression and response to this chemotherapy combination and relation to progression free survival.|Baseline, over the course of treatment, about 1 year|Data were not collected for this outcome measure.|||||
744700|NCT00503906|Secondary|Relationship Between Circulating Tumor Cells (CTC) and Disease Progression as Measured by Presence of CTC at Baseline and Over the Course of Study Treatment|Exploration of the relationship between circulating tumor cells (CTC) and disease progression, by measuring CTC at baseline and over the course of treatment.|Baseline, over the course of Treatment, about 1 year|Data were not collected for this outcome measure.|||||
744701|NCT00503906|Secondary|Rate of Toxicity in Study Participants|Determination of safety and side effect profile of the protocol therapy including the rate of toxicity in study participants. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for adverse event reporting.|Over the course of study treatment.|||percentage of participants|||Number
744702|NCT00503906|Secondary|Rates of Partial Response (PR), Complete Response (CR) and Overall Response (ORR) in Study Participants|Rates of partial response (PR), complete response (CR) and overall response (PR+CR = ORR) in study participants according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0.|After two cycles, about 60 days|Evaluable patients are study-eligible patients who receive an initial infusion of combination chemotherapy consisting of Gemcitabine, NAB paclitaxel and Bevacizumab and have had at least one CT scan for evaluation of disease status.||percentage of participants|||Number
744707|NCT00503984|Secondary|Duration of Response|Length of time from the date of first observation of complete response (CR) or partial response (PR) to the date of first observation of disease progression, according to prostate-specific antigen (PSA) response according to Prostate Cancer Working Group 1 (PCWG1) criteria. PSA response according to PCWG1 is defined as an least 50 percent decline in PSA level from baseline that was maintained for at least three weeks.|Up to 4.5 years.|The 10 participants in both Phase 1 and Phase 2 who achieved PSA response.||weeks||Full Range|Median
744708|NCT00503984|Primary|Number of Participants Achieving Complete Response (CR) or Partial Response (CR) to Protocol Therapy.|"Number of participants achieving Complete Response (CR) or Partial Response to protocol therapy according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.0 Criteria. Per RECIST 1.0 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; "|Up to 4.5 years|Number of evaluable participants with measurable disease on CT scan. Only 10 of the 19 evaluable participants had measurable disease on CT Scan.||participants|||Number
744709|NCT00503984|Primary|Number of Participants Achieving Prostate-specific Antigen (PSA) Response.|Number of participants achieving prostate-specific antigen (PSA) response according to Prostate Cancer Working Group 1 (PCWG1) criteria. PSA response according to PCWG1 is defined as an least 50 percent decline in PSA level from baseline that was maintained for at least three weeks.|Up to 4.5 years.|Of the 22 participants enrolled, only 19 were evaluable because they completed 2 or more cycles of protocol therapy.||participants|||Number
744710|NCT00503984|Primary|Phase I - Recommended Phase Two Dose (RPTD) of Azacitidine and Docetaxel in Combination With Prednisone. (Prednisone)|Determination of a safe and potentially efficacious phase II dose of azacitidine in combination with docetaxel and prednisone that can be used for the treatment of hormone refractory metastatic prostate cancer.|Up to 1.5 years|Number of participants enrolled in the Phase 1 portion of the study. The initial RPTD was 150 mg/m2 Azacitidine + 75 mg/m2 Docetaxel, with 5mg of Prednisone. However, due to the death of one patient, the Data and Safety Monitoring Board (DSMB) recommended that the RPTD be reduced to 75 mg/m2 Azacitidine + 75 mg/m2 Docetaxel, with 5mg of Prednisone.||mg|||Number
744711|NCT00503984|Primary|Phase I - Recommended Phase Two Dose (RPTD) of Azacitidine and Docetaxel in Combination With Prednisone. (Azacitidine and Docetaxel)|Determination of a safe and potentially efficacious phase II dose of azacitidine in combination with docetaxel and prednisone that can be used for the treatment of hormone refractory metastatic prostate cancer.|Up to 1.5 years|Number of participants enrolled in the Phase 1 portion of the study. The initial RPTD was 150 mg/m2 Azacitidine + 75 mg/m2 Docetaxel, with 5mg of Prednisone. However, due to the death of one patient, the Data and Safety Monitoring Board (DSMB) recommended that the RPTD be reduced to 75 mg/m2 Azacitidine + 75 mg/m2 Docetaxel, with 5mg of Prednisone.||mg/m2|||Number
744712|NCT00503997|Primary|Patient Response to Treatment Measured by RECIST Criteria|RECIST response categories: Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.|at 8 weeks|||participants|||Number
744713|NCT00504075|Secondary|Duration of Time That the Platelet Count of Subjects With Chronic ITP Treated With Gammaplex Remained ≥ 50 x 10^9/L.|Blood samples were collected to measure platelet counts and the duration of time for which the platelet count remained ≥50 x 10^9/L was measured.|Days 1, 2, 3, 5, 9, 14, 21, 32.|Any subject who started treatment with GAMMAPLEX and whose central laboratory results taken prior to infusion on Day 1 were within specified protocol parameters, was included in the intent-to-treat (ITT) population for analysis of efficacy and safety.||days||95% Confidence Interval|Median
744714|NCT00504075|Secondary|The Safety of GAMMAPLEX at the Dosage Used in This Study.|"The safety variables used to assess safety were the following:
Adverse events
The number and percent of infusions with at least 1 adverse event(AE) that occurs during an infusion or within 72 hours after the infusion stops
Nature, severity, and frequency of AEs
Suspected unexpected serious adverse reactions (SUSARs)
Vital signs
Clinical laboratory tests and Direct Coombs’ Test
Transmission of viruses
Physical examination"|AEs were documented from the date the informed consent form was signed until the End of Study visit on Day 90.|Any subject who started treatment with GAMMAPLEX and whose central laboratory results taken prior to infusion on Day 1 were within specified protocol parameters, was included in the intent-to-treat (ITT) population for analysis of efficacy and safety.||% of subjects with product related SAEs||95% Confidence Interval|Number
744715|NCT00504075|Primary|The Number of Subjects With Chronic ITP Treated With Gammaplex Whose Platelet Count Reached a Threshold of 50 x 10^9/L.|The number of subjects with chronic ITP treated following treatment with Gammaplex who attained a platelet count of ≥ 50 x 10^9/L by Day 9.|9 days|Any subject who started treatment with GAMMAPLEX and whose central laboratory results taken prior to infusion on Day 1 were within specified protocol parameters, was included in the intent-to-treat (ITT) population for analysis of efficacy and safety.||participants|||Number
744716|NCT00504153|Secondary|Change in Plasma Vascular Endothelial Growth Factor (VEGF) Levels Over 15 Days|Changes of VEGF will be correlated with response rates and 4-month progression-free survival utilizing the Wilcoxon rank-sum test.|At baseline and day 15|This outcome was not assessed for any of the patients.|||||
744717|NCT00504153|Secondary|Association Between the Incidence of Total C-src and Phosphorylated C-src Expression and Response|Examined by comparing expression in those who have an objective response versus those who do not and in those with and without disease progression at 4 months using Fisher’s exact test.|4 months|This outcome was not assessed for any of the patients.|||||
744718|NCT00504153|Secondary|Incidence of Somatic Mutations|Multivariable analysis of progression-free survival duration will be performed using the Cox (1972) regression model to evaluate the prognostic value of somatic mutations. For the mutational analysis endpoints, genetic mutations will also be correlated with drug activity via Fisher’s exact test for comparisons of responders with non-responders and for comparison of patients progression-free and 4 months vs. those with early progression or death|1 year|This outcome was not assessed for any of the patients.|||||
745106|NCT00512902|Secondary|Change in DLco|DLCO (diffusing capacity or transfer factor of the lung for carbon monoxide (CO)) is the extent to which oxygen passes from the air sacs of the lungs into the blood. Commonly, it refers to the test used to determine this parameter.|Baseline vs. Endpoint (1 year)|||Percent predicted||Standard Deviation|Mean
744719|NCT00504153|Secondary|Response Rate (RR) (Complete or Partial Responders)|Response will be evaluated in this study using the new international criteria proposed by the RECIST Committee. The response rate is the proportion of subjects who experienced a complete or partial response.|Every 2 courses, assessed up to 8 weeks after completion of study treatment (i.e., up to 10 months)|||percentage of participants|||Number
744720|NCT00504153|Primary|Progression-free Survival Rate|Progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Patients who are still alive and have not progressed will be censored at the date of the last negative examination. A Simon (1989), optimal, two-stage design will be employed. The progression-free survival count will be the proportion of subjects who are alive and progression-free at 4 months.|From the start of treatment to the time of disease progression or death from any cause, assessed at 4 months after completion of treatment (i.e., up to 12 months.)|||percentage of participants|||Number
744721|NCT00504166|Primary|Mean % Change From Baseline in Trabecular Number (Tb.N) by HR-pQCT|Trabecular number is a three-dimensional measure of the mean inter-trabecular distance; the primary micro-architectural feature measured by high-resolution CT imaging. The parameter was calculated from scans of the distal radius and distal tibia at baseline, 12, and 24 months. The percent change from baseline over these time periods was calculated as the primary outcome measure indicating the micro-architectural status of trabecular bone.|Baseline, 24 months|final statistical analysis was performed per protocol||Percent change||Standard Deviation|Mean
744722|NCT00509873|Post-Hoc|Percentage of Patients With Clearing (Clinical Success) of Conjunctival Hyperemia and Conjunctival Discharge Up to Day 6|"Percentage of patients that achieved clinical success, defined as achievement of a score of zero for both conjunctival hyperemia and conjunctival discharge in the study eye up to Day 6. Conjunctival hyperemia and conjunctival discharge were each assessed on a 4-point severity grade scale (0=none, +1=mild, +2=moderate, +3=severe). (Note: The Up to Day 6 analysis included all data up to the Day 6 time point but excluded any Day 6 visit data that was collected after the Day 6 time point)."|6 Days|"Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria. (Note: The Up to Day 6 analysis included all data up to the Day 6 time point but excluded any Day 6 visit data that was collected after the Day 6 time point)."||Percentage of Patients|||Number
744723|NCT00509873|Secondary|Percentage of Patients With Clinical Improvement of Ocular Symptoms at Day 6|Percentage of patients with clinical improvement of ocular symptoms at Day 6, defined as a decrease (improvement) from Day 1 (Baseline) in the total score of itching and tearing (each on 4-point scale: 0 = none, 1 = mild, 2 = moderate, and 3 = severe), with no increase (worsening) from Day 1 (Baseline) in any individual score in the study eye diagnosed with bacterial conjunctivitis|Day 6|"Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria. (Note: The Day 6 analysis included all Day 6 visit data, regardless of whether it was collected on Day 6 or on a later day)."||Percentage of Patients|||Number
744724|NCT00509873|Secondary|Percentage of Patients With Clinical Improvement of Ocular Signs at Day 6|Percentage of patients with clinical improvement of ocular signs at Day 6 based on a 4-point scale (0 = none, 1 = mild, 2 = moderate, and 3 = severe), defined as a decrease (improvement) from Day 1 (Baseline) in the total score of conjunctival hyperemia and mucopurulent discharge (pus),with no increase (worsening) from Day 1 (Baseline) in either individual variable in the study eye.|Day 6|"Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria. (Note: The Day 6 analysis included all Day 6 visit data, regardless of whether it was collected on Day 6 or on a later day)."||Percentage of Patients|||Number
744725|NCT00509873|Secondary|Percentage of Patients With Microbiological Cure at Day 6|Percentage of patients with microbiological cure, defined such that all bacteria present in the study eye at Day 1 (Baseline) are eradicated (or absent) at Day 6 based on a Classification of Microbial Response. (Eradication=pathogen is absent in follow-up culture; Reduction=pathogen is reduced from baseline below threshold count in follow-up culture; Persistence=pathogen reduced from baseline but is above or equal to threshold count in follow-up culture; and Proliferation=pathogen has increased in count from baseline in follow-up culture)|Day 6|"Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria. (Note: The Day 6 analysis included all Day 6 visit data, regardless of whether it was collected on Day 6 or on a later day)."||Percentage of Patients|||Number
744726|NCT00509873|Primary|Percentage of Patients With Clearing (Clinical Success) of Conjunctival Hyperemia and Conjunctival Discharge at Day 6|Percentage of patients that achieved clinical success, defined as achievement of a score of zero for both conjunctival hyperemia and conjunctival discharge in the study eye at Day 6. Conjunctival hyperemia and conjunctival discharge were each assessed on a 4-point severity grade scale (0=none, +1=mild, +2=moderate, +3=severe).|Day 6|"Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria. (Note: The Day 6 analysis included all Day 6 visit data, regardless of whether it was collected on Day 6 or on a later day)."||Percentage of Patients|||Number
744727|NCT00509899|Secondary|Change From Baseline to Week 24 in Eastern Cooperative Oncology Group (ECOG) Performance Status|"The ECOG performance status measures patients' functional status on the following scale:
0=Fully active, no restrictions;
1=Restricted in physically strenuous activity but ambulatory, able to carry out light work;
2=Ambulatory and capable of all selfcare, unable to carry out any work activities; Up and about > 50% of waking hours;
3=Limited selfcare, confined to bed or chair more than 50% of waking hours;
4=Completely disabled. Totally confined to bed or chair;
5=Dead.
Data reported indicate the number of participants with a change from Baseline score of -2, -1, 0 and 1."|Baseline and Week 24|Intent-to-treat population for patients who had reached each time point and for whom data was available.||participants|||Number
744728|NCT00509899|Secondary|Change From Baseline in Body Weight Over Time||Baseline and Weeks 4, 8, 12, 24, 36, 48 and 60.|Intent-to-treat population for patients who had reached each time point and for whom data was available.||kg||Standard Deviation|Mean
744741|NCT00509925|Secondary|Hormonal Assessment: Insulin-like Growth Factor-1|Insulin-like growth factor-1 (IGF-1) levels after each treatment period.|Week 14, week 30|The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint.||ng/ml||Standard Deviation|Mean
774281|NCT00746590|Secondary|Time to Tumour Progression||Every 3 weeks until progression||||||
744729|NCT00509899|Secondary|Change From Baseline to Week 24 in Health-Related Quality of Life|Health-related Quality of Life was assessed using the Global Health Status/Quality of Life Scale of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). This scale ranges from 0 to 100, with higher scores indicating higher quality of life.|Baseline and Week 24|The safety population included all subjects who received at least 1 dose of study medication, and for whom data was available at both time points. The EORTC QLQ C30 was implemented by protocol amendment and as a result this data are available for only approximately 50% of the enrolled patients.||units on a scale||Standard Deviation|Mean
744730|NCT00509899|Secondary|Change From Baseline in Myelofibrosis Total Symptom Score at Week 24|Symptoms of myelofibrosis were assessed using a modified Myelofibrosis Symptom Assessment Form (MFSAF). Abdominal discomfort, itching, muscle or bone pain, and night sweats are prominent and troubling symptoms in patients with MF. Therefore, the MFSAF-derived responses for these symptoms were analyzed as a total symptom score. Each symptom was assessed on a scale from 0 (absent), 1 (most favorable) to 10 (worst). The total symptom score is a sum of the individual scores and ranges from 0-40. A higher score indicates worse symptoms hence a negative change from baseline indicates improvement.|Baseline and Week 24|Intent-to-treat population for whom data was available. The MFSAF was implemented by protocol amendment while the study was ongoing. Hence data are available for only approximately 50% of enrolled patients. This analysis includes patients with a Baseline total symptom score ≥ 0; 8 patients were excluded because they had a Baseline score = 0.||scores on a scale||Standard Deviation|Mean
744731|NCT00509899|Secondary|Percentage of Participants With ≥ 35% Reduction From Baseline in Spleen Volume Over Time|"Spleen volume was assessed in a subgroup of 27 patients using magnetic resonance imaging (MRI) scans (or computed tomography (CT) scans in patients who were not candidates for MRI) of the abdomen in order to allow objective measurement of spleen volume using standard estimation techniques.
For each visit, patients who had a missing value at the visit or dropped out of the study due to any reason prior to the visit were considered as not having achieved the ≥35% reduction in spleen volume."|Baseline, Weeks 4, 12, 24 and 48|Patients with at least 1 Spleen-Volume Measurement. Patients who had not reached the visit were excluded from the analysis. In addition, at Week 48, 5 patients who did not have MRI measurement due to a protocol amendment were considered as not evaluable and were excluded from the analysis.||percentage of participants|||Number
744732|NCT00509899|Secondary|Percentage of Participants Achieving ≥ 50% Reduction From Baseline in Spleen Palpation Length Over Time|For each visit, patients who had a missing value at the visit, dropped out of the study due to any reasons prior to the visit or had non-palpable spleen at baseline and then became palpable at the time of the visit were all considered as having not achieved the ≥ 50% reduction in spleen palpation length.|Baseline and Weeks 4, 8, 12, 24, 36, 48 and 60|Intent to treat population. A total of 16 patients had either a splenectomy prior to study entry, missing Baseline spleen values or had spleen lengths reported as 0 cm and were excluded.||percentage of participants|||Number
744733|NCT00509899|Primary|Percentage of Participants With Clinical Improvement (CI) Over Time|"Clinical improvement was defined according to the International Working Group Myelofibrosis Research and Treatment criteria, and required 1 of the following:
A ≥ 2 g/dL increase in Hemoglobin level or becoming transfusion independent;
Either a ≥ 50% reduction in palpable splenomegaly if spleen was ≥ 10 cm at Baseline or a spleen palpable at > 5 cm at Baseline becomes not palpable;
A ≥ 100% increase in platelet count and an absolute platelet count of ≥ 50,000 x 10^9/L or
A ≥ 100% increase in absolute neutrophil count (ANC) and an ANC of ≥ 0.5 x 10^9/L."|Week 12, 24, 36, 48 and 60|The intent-to-treat population included all patients who received at least 1 dose of study medication and had at least 1 follow-up assessment for safety and efficacy. N = the number of patients who had clinical response assessed during the time interval.||percentage of participants|||Number
744734|NCT00509899|Primary|Number of Participants With Adverse Events (AEs)|"Treatment-Emergent AEs are events occurring after first drug administration or worsened from baseline.
Treatment-Related AEs are those with a definite, probable, possible or missing causality.
A serious AE is a medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is a medical event requiring intervention to prevent 1 of the above.
A severe or life-threatening AE is based on intensity, according to National Cancer Institute-Common Toxicity Criteria for Adverse Effects (NCI-CTCAE) v3.0."|From Baseline to the interim clinical cut-off date (31 December 2009). The median time on study was 14.8 months, with a range of 26 days to 29.7 months. As of March 1, 2011 the total exposure to ruxolitinib was 269 patient-years.|Safety population included all patients who received at least 1 dose of study medication.||participants|||Number
744735|NCT00509925|Secondary|Hypoglycaemic Episodes, Diurnal/Nocturnal|Total number of hypoglycaemic episodes during the day (diurnal) and the night (nocturnal) experienced in the study.|Weeks 0-32|The safety analysis set included all randomised and exposed subjects.||episodes|||Number
744736|NCT00509925|Secondary|Hypoglycaemic Episodes|Total number of hypoglycaemic episodes experienced in the study.|Weeks 0-32|The safety analysis set included all randomised and exposed subjects.||episodes|||Number
744737|NCT00509925|Secondary|Fasting Plasma Glucose|Fasting plasma glucose (FPG) after each treatment period.|Week 16, week 32|The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint.||mmol/L||Standard Deviation|Mean
744738|NCT00509925|Secondary|Glycosylated Haemoglobin A1c (HbA1c)|Glycosylated haemoglobin A1c (HbA1c) after each treatment period.|Week 16, week 32|The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint.||percentage of total haemoglobin||Standard Deviation|Mean
744739|NCT00509925|Secondary|Hormonal Assessment: Leptin|Leptin levels after each treatment period.|Week 14, week 30|The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint.||ng/ml||Standard Deviation|Mean
744740|NCT00509925|Secondary|Hormonal Assessment: Resistin|Resistin levels after each treatment period.|Week 14, week 30|The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint.||ng/ml||Standard Deviation|Mean
774526|NCT00748969|Secondary|Change in Bone Mineral Density, Content, and Strength by DXA and pQCT, and Change in Serum Markers of Bone Metabolism.||12 months||||||
744743|NCT00509925|Secondary|Waist:Hip Ratio|At each time-point, 3 measurements each of waist and hip circumference were taken, then an average across the three measurements was calculated for both and the ratio was calculated as the waist average in cm divided by hip average in cm, and multiplied by 100.|Week 16, week 32|The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint.||percentage of hip circumference||Standard Deviation|Mean
744744|NCT00509925|Secondary|Fat Mass|Fat mass was measured using Bioelectrical Impedance Analysis (BIA), a method used for estimating body composition.|Week 16, week 32|The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint.||kg||Standard Deviation|Mean
744745|NCT00509925|Secondary|Lean Body Mass|Lean body mass was measured using Bioelectrical Impedance Analysis (BIA), a method used for estimating body composition.|Week 16, week 32|The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint.||kg||Standard Deviation|Mean
744746|NCT00509925|Secondary|Body Weight|Body weight after each treatment period.|Week 16, week 32|The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint.||kg||Standard Deviation|Mean
744747|NCT00509925|Secondary|Component of Total Energy Expenditure: Non-exercise Activity Thermogenesis (NEAT)|Non-exercise activity thermogenesis is a component of TEE (total energy expenditure). Thermic efficiency was assessed by measuring O2 consumption/CO2 production while the subject exercised on a bike for 20 minutes while hooked up to a device that recorded their respiration (visit in week 14 and week 30). If thermic efficiency was unchanged and volitional exercise was unchanged, then any change in physical activity thermogenesis was due to changes in NEAT.|Week 16, week 32|The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint.||kcal/day||Standard Deviation|Mean
744748|NCT00509925|Secondary|Component of Total Energy Expenditure: Physical Activity Thermogenesis|Physical activity thermogenesis is a component of TEE (total energy expenditure). Subjects were asked not to change their physical activity levels. Physical activity thermogenesis can be calculated as the difference between TEE minus (REE + DIT), as long as volitional exercise is unchanged. Volitional exercise was assessed using Actiheart 3-D monitor readings. Subjects were asked to measure their normal activity for between 1 and 5 days prior to their visits at week 16 and week 32).|Week 16, week 32|The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint.||kcal/day||Standard Deviation|Mean
744749|NCT00509925|Primary|Total Energy Expenditure, Dietary Record Method|The total energy expenditure (TEE) measured after each treatment period by the dietary record method. The calculation of energy balance is accomplished by compiling an accurate record of food intake over a period of time and measuring any changes in body weight that occur during that time. Data from the 7-day food diary was used to calculate TEE.|Weeks 14-16, weeks 30-32|The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint.||kcal/day||Standard Deviation|Mean
744750|NCT00509925|Secondary|Component of Total Energy Expenditure: Diet Induced Thermogenesis (DIT)|Diet induced thermogenesis (DIT) is a component of TEE (total energy expenditure) and is the energy expenditure following feeding for anabolic processes. Subjects fasted overnight and rested for 1 hour. Multiple measurements of REE (resting energy expenditure) were taken. A fixed 600 kcal liquid meal was given and REE was measured over the next 3 hours. DIT was calculated as area under the curve of total REE-resting REE for the 3-hour period and was then converted to a per day measurement by taking into account each individual’s average daily food intake.|Week 14, week 30|The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint.||kcal/day||Standard Deviation|Mean
744751|NCT00509925|Secondary|Component of Total Energy Expenditure: Resting Energy Expenditure (REE)|Resting energy expenditure (REE) is a component of TEE (total energy expenditure). It was measured at 2 different timepoints during the trial using indirect calorimetry (measurement of O2 consumption/CO2 production) after an overnight fast when subjects would be metabolising a mixture of carbohydrate and free fatty acid. This technique allowed the calculation of the rate of carbohydrate and lipid oxidation.|Week 14, week 30|The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint.||kcal/day||Standard Deviation|Mean
744752|NCT00509925|Primary|Total Energy Expenditure, Double-labelled Water Method|Total energy expenditure (TEE) measured after each treatment period by the double-labelled water (DLW) method. This technique required subjects to label their body water using oral administration of water labelled with 2 stable isotopes (2H218O). The clearance of 2H and 18O was measured over a two week period with daily collections of urine. The difference between the clearance of 2H and 18O is a measure of CO2 production rate. This can be converted to provide a measure of energy expenditure.|Weeks 14-16, weeks 30-32|The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint.||kcal/day||Standard Deviation|Mean
744753|NCT00510068|Secondary|Plasma Angiogenesis Marker: Vascular Endothelial Growth Factor (VEGF)|This biomarker is related to angiogenesis pathway, was analyzed to determine the effects of everolimus on plasma antiangiogenic molecules.|Baseline, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1|The Full Analysis Set (FAS) consists of all patients who were randomized.||pg/mL||Standard Deviation|Mean
744754|NCT00510068|Secondary|Plasma Angiogenesis Marker: Soluble Vascular Endothelial Growth Factor Receptor 2 (sVEGFR2)|This biomarker is related to angiogenesis pathway, was analyzed to determine the effects of everolimus on plasma antiangiogenic molecules.|Baseline, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1|The Full Analysis Set (FAS) consists of all patients who were randomized.||pg/mL||Standard Deviation|Mean
744755|NCT00510068|Secondary|Plasma Angiogenesis Marker: Soluble Vascular Endothelial Growth Factor Receptor 1 (sVEGFR1)|This biomarker is related to angiogenesis pathway, was analyzed to determine the effects of everolimus on plasma antiangiogenic molecules.|Baseline, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1|The Full Analysis Set (FAS) consists of all patients who were randomized.||pg/mL||Standard Deviation|Mean
744756|NCT00510068|Secondary|Plasma Angiogenesis Marker: Placental Growth Factor (PLGF)|This biomarker is related to angiogenesis pathway, was analyzed to determine the effects of everolimus on plasma antiangiogenic molecules.|Baseline, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1|The Full Analysis Set (FAS) consists of all patients who were randomized.||pg/mL||Standard Deviation|Mean
744757|NCT00510068|Secondary|Plasma Angiogenesis Marker: Basic Fibroblast Growth Factor (bFGF)|This biomarker is related to angiogenesis pathway, was analyzed to determine the effects of everolimus on plasma antiangiogenic molecules.|Baseline, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1|The Full Analysis Set (FAS) consists of all patients who were randomized.||pg/mL||Standard Deviation|Mean
744758|NCT00510068|Secondary|Analysis of Time to Definitive Deterioration of WHO Performance Status Using Kaplan-Meier|Time to definitive worsening is defined as a definitive increase in performance status from a baseline of 0 or 1 to WHO >= 2, or from a baseline value of 2 to WHO >= 3. If no earlier deterioration, patients were censored at the end of follow-up or at the start of further antineoplastic therapy. Rates of patients with no deterioration at 3 and 6 months were computed using Kaplan-meier method. Grade 0: Able to carry out all activity without restriction; Grade 1: Restricted in physically strenuous activity but ambulatory & able to do light work; Grade 2: Ambulatory & capable of all self-care but unable to carry out any work. Up & about more than 50% of waking hours; Grade 3: Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; Grade 4: Completely disabled & cannot carry on any self-care; totally confined to bed or chair.|3 months, 6 months|The Full Analysis Set (FAS) consists of all patients who were randomized.||% of participants with no deterioration|||Number
744759|NCT00510068|Secondary|Evaluation of Pharmacokinetics (PK) Parameter: Tmax -Time to Maximum (Peak) Drug Concentration|The PK parameters for a full PK profile at steady-state were determined in blood using non compartmental methods. Values for tmax where summarized in median (range).|Day 1 of every cycle (28 days/cycle) throughout the study|The Safety Set consisted of all patients who received any study drug and had at least one postbaseline safety assessment.||h||Full Range|Median
744760|NCT00510068|Secondary|Evaluation of Pharmacokinetics (PK) Parameter: CL/F|The PK parameters for a full PK profile at steady-state were determined in blood using non compartmental methods. The PK parameter clearance of distribution expressed as a function of bioavailability (CL/F).|Day 1 of every cycle (28 days/cycle) throughout the study|The Safety Set consisted of all patients who received any study drug and had at least one postbaseline safety assessment.||L/h||Standard Deviation|Mean
744761|NCT00510068|Secondary|Evaluation of Pharmacokinetics (PK) Parameters: Cmax, Cmin|The PK parameters for a full PK profile at steady-state were determined in blood using non compartmental methods. The PK parameter: maximum (peak) drug concentration (Cmax) and minimum (trough) drug concentration (Cmin).|Day 1 of every cycle (28 days/cycle) throughout the study|The Safety Set consisted of all patients who received any study drug and had at least one postbaseline safety assessment.||ng/mL||Standard Deviation|Mean
744762|NCT00510068|Secondary|Evaluation of Pharmacokinetics (PK) Parameter: AUC0-t Last|The PK parameters for a full PK profile at steady-state were determined in blood using non compartmental methods. This PK parameter is area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-t last).|Day 1 of every cycle (28 days/cycle) throughout the study|The Safety Set consisted of all patients who received any study drug and had at least one postbaseline safety assessment.||ng.h/mL||Standard Deviation|Mean
744763|NCT00510068|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) (Open-label Period)|Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.|on or after the start of open-label study medication until no later than 28 days after open-label study medication discontinuation|The open-label set was used to summarize the safety analyses performed on data collected in the open-label period of the study: the open-label set included only patients who received at least one dose of open-label everolimus 10 mg and had at least one safety assessment during the open-label period of the study.||Participants|||Number
744764|NCT00510068|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs)|Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.|on or after the start of double-blind study medication until no later than 28 days after double-blind study medication discontinuation|The Safety Set consists of all patients who received any study drug and had at least one post-baseline safety assessment.||Participants|||Number
744765|NCT00510068|Secondary|Progression Free Survival According to Neuron Specific Enolase Tumor Marker (NSE) Baseline Level and According to NSE Early Response|"Baseline levels of serum NSE were characterized towards PFS as per local investigator assessment, relative to the upper limited of normal (ULN). NSE levels exceeding ULN were considered to be 'Elevated' otherwise considered as Non-elevated. An ‘early response’ (applicable to only those patients with elevated levels at baseline) was defined as a decrease of greater than or equal to 30% from baseline to Cycle 2 Day 1 or normalization by Cycle 2 Day 1. NSE is widely expressed in well-differentiated pancreatic NET. NSE is usually expressed in the cytoplasm. Pancreatic NET patients often present with elevated circulating levels of NSE in their blood. Baseline levels of these biomarkers are considered as prognostic factors."|Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 17 August 2007, until cut-off date 28 February 2010|The Full Analysis Set (FAS) consisted of all patients who were randomized.||Months||95% Confidence Interval|Median
744778|NCT00510146|Secondary|Change From Baseline to Endpoint in Platelet Count (Open-Label Phase)||Baseline (End of Acute Phase/Week 6), Endpoint (Week 24)|Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF).||billion cells per liter (BILL/L)||Standard Deviation|Mean
744766|NCT00510068|Secondary|Progression Free Survival According to Chromogramin A Tumor Marker (CgA) Baseline Level and According to CgA Early Response|"Baseline levels of serum CgA SE were characterized towards progression free survival (PFS) as per local investigator assessment, relative to the upper limited of normal (ULN). CgA levels exceeding 2 x ULN were considered to be 'Elevated' otherwise considered as Non-elevated. An ‘early response’ (applicable to only those patients with elevated levels at baseline) was defined as a decrease of greater than or equal to 30% from baseline to Cycle 2 Day 1 or normalization by Cycle 2 Day 1. CgA is widely expressed in well-differentiated pancreatic NET. CgA is present in the secretory granules of neuroendocrine cells. Pancreatic NET patients often present with elevated circulating levels of CgA in their blood. Baseline levels of these biomarkers are considered as prognostic factors."|Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 17 August 2007, until cut-off date 28 February 2010|The Full Analysis Set (FAS) consisted of all patients who were randomized.||Months||95% Confidence Interval|Median
744767|NCT00510068|Secondary|Progression Free Survival According to Ki-67 Levels Categorized as: Less Than or Equal to 2%, > 2% to Less Than or Equal to 5% and > 5%|The level of Ki 67 expression for evaluable tumor samples were analyzed towards progression free survival (PFS) as per local investigator assessment. The Ki-67 protein is a cellular marker for proliferation. It is strictly associated with cell proliferation. During interphase, the Ki-67 antigen can be exclusively detected within the cell nucleus, whereas in mitosis most of the protein is relocated to the surface of the chromosomes. Baseline Ki 67 levels were categorized as: less than or equal to 2%, > 2% to less than or equal to 5% and > 5%.|Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 17 August 2007, until cut-off date 28 February 2010|The Full Analysis Set (FAS) consisted of all patients who were randomized.||Months||95% Confidence Interval|Median
744768|NCT00510068|Secondary|Overall Survival|Overall survival (OS) was defined as the time from date of randomization to the date of death due to any cause. Analyses were performed using all deaths in the FAS population regardless of whether they were observed during the double-blind treatment period, the open-label treatment period, the post-treatment evaluations, or the survival follow-up period.|Baseline, to death- no time limit|The Full Analysis Set (FAS) included all randomized patients.||Months||95% Confidence Interval|Median
744769|NCT00510068|Secondary|Percentage of Participants With Objective Response Rate ( CR {Complete Response} OR PR {Partial Response})|Objective Response defined by RECIST criteria: Partial response (PR) must have ≥ 30% decrease in the sum of the longest diameter of all target lesions, from the baseline sum. Complete response (CR) must have disappearance of all target and non-target lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments within 4 weeks . Progression = 20% increase in the sum of the longest diameter of all target lesions, from the smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions|Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 17 August 2007, until cut-off date 28 February 2010|The Full Analysis Set (FAS) consists of all patients who were randomized.||Percentage of participants||95% Confidence Interval|Number
744770|NCT00510068|Primary|Time to Progression Free Survival (PFS) Based as Per Investigator Using Kaplan-Meier Methodology|Progression of disease is defined as the time from study start to the date of first documented progression of disease or death due to any cause. Progression of disease is defined by RECIST criteria: Progression = 20% increase in the sum of the longest diameter of all target lesions, from the smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions.|Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 17 August 2007, until cut-off date 28 February 2010|The Full Analysis Set (FAS) consists of all patients who were randomized.||Months||95% Confidence Interval|Median
744771|NCT00510146|Secondary|Number of Participants With Adverse Events (Open-Label Phase)|Please refer to the Adverse Event overview for details regarding adverse events and serious adverse events.|Baseline (End of Acute Phase/Week 6) through Endpoint (Week 24)|Total participants in the open-label extension phase.||participants|||Number
744772|NCT00510146|Secondary|Percentage of Participants With High Suicidality at Endpoint (Open-Label Phase)|The MINI module C (MINI-C) is a rating scale for severity of suicidal thoughts and behaviors. The MINI-C is composed of 12 Yes/No questions with variable scores assigned to each question. The scale ranges from 0 to 52 with higher scores indicating a greater presence of suicidal thoughts and/or behaviors. Based upon scores, suicidality is defined as Low (1-8), Medium (9-16), and High (>=17).|Endpoint (Week 24)|Total participants in the open-label extension phase.||percentage of participants|||Number
744773|NCT00510146|Secondary|Change From Baseline to Endpoint in Heart Rate (Open-Label Phase)||Baseline (End of Acute Phase/Week 6), Endpoint (Week 24)|Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF).||beats per minute||Standard Deviation|Mean
744774|NCT00510146|Secondary|Change From Baseline to Endpoint in ECG (Open-Label Phase)|Time from electrocardiogram Q wave to the end of the T wave corresponding to electrical systole, fixed correction factor (QTcF interval); Bazett-Corrected QT Interval (QTcB interval).|Baseline (End of Acute Phase/Week 6), Endpoint (Week 24)|Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF).||milliseconds||Standard Deviation|Mean
744775|NCT00510146|Secondary|Change From Baseline to Endpoint in Glucose and Lipids (Cholesterol, Triglycerides, HDL Cholesterol, LDL Cholesterol) (Open-Label Phase)||Baseline (End of Acute Phase/Week 6), Endpoint (Week 24)|Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF).||millimole/Liter||Standard Deviation|Mean
744776|NCT00510146|Secondary|Change From Baseline to Endpoint in Uric Acid (Open-Label Phase)||Baseline (End of Acute Phase/Week 6), Endpoint (Week 24)|Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF).||micromole/Liter||Standard Deviation|Mean
744777|NCT00510146|Secondary|Change From Baseline to Endpoint in Prolactin (Open-Label Phase)||Baseline (End of Acute Phase/Week 6), Endpoint (Week 24)|Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF).||microgram/Liter||Standard Deviation|Mean
744779|NCT00510146|Secondary|Change From Baseline to Endpoint in Hemoglobin (Open-Label Phase)||Baseline (End of Acute Phase/Week 6), Endpoint (Week 24)|Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF).||millimole/Liter of iron (Fe)||Standard Deviation|Mean
744780|NCT00510146|Secondary|Change From Baseline to Endpoint in Erythrocyte Count (Open-Label Phase)||Baseline (End of Acute Phase/Week 6), Endpoint (Week 24)|Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF).||trillion cells per liter (Tril/L)||Standard Deviation|Mean
744781|NCT00510146|Secondary|Change From Baseline to Endpoint in Creatinine (Open-Label Phase)||Baseline (End of Acute Phase/Week 6), Endpoint (Week 24)|Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF).||micromole/Liter||Standard Deviation|Mean
744782|NCT00510146|Secondary|Change From Baseline to Endpoint in Chloride (Open-Label Phase)||Baseline (End of Acute Phase/Week 6), Endpoint (Week 24)|Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF).||millimole/Liter||Standard Deviation|Mean
744783|NCT00510146|Secondary|Change From Baseline to Endpoint in Alkaline Phosphatase, Creatinine Phosphokinase (CPK), GGT (Open-Label Phase)||Baseline (End of Acute Phase/Week 6), Endpoint (Week 24)|Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF).||units/Liter||Standard Deviation|Mean
744784|NCT00510146|Secondary|Change From Baseline to Endpoint in Albumin and Total Protein (Open-Label Phase)||Baseline (End of Acute Phase/Week 6), Endpoint (Week 24)|Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF).||gram/Liter||Standard Deviation|Mean
744785|NCT00510146|Secondary|Change From Baseline to Endpoint in Weight (Open-Label Phase)||Baseline (End of Acute Phase/ Week 6), Endpoint (Week 24)|Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF).||kilograms||Standard Deviation|Mean
744786|NCT00510146|Secondary|Change From Baseline to Endpoint in Blood Pressure (Open-Label Phase)||Baseline (End of Acute Phase/Week 6), Endpoint (Week 24)|Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF).||millimeters of mercury||Standard Deviation|Mean
744787|NCT00510146|Secondary|Percentage of Participants With Extra-Pyramidal Symptoms (EPS) at Endpoint As Measured by Drug-Induced Extra-Pyramidal Symptoms Scale (DIEPSS) (Open-Label Phase)|EPS symptoms measured by DIEPSS are grouped into 4 categories: parkinsonism, akathisia, dystonia, and dyskinesia. Severity is assessed at 5 levels, from level 0 (none, normal) to level 4 (severe). For Parkinsonism, normal baseline is defined as a score not >=3 on 1 item nor >=2 on 2 items; abnormal endpoint is defined as a score >=3 on 1 item or >=2 on 2 items, or an increase of 3 on Parkinsonism total. Baseline akathisia, dystonia and dyskinesia is defined as a score <2; abnormal endpoint is a score >=2 or an increase >= 2 from that baseline score.|Endpoint (Week 24)|Participants who entered Open-Label Phase with a normal baseline and at least one post-baseline result.||percentage of participants|||Number
744788|NCT00510146|Secondary|Percentage of Participants With Emergence of Mania During the Study (Open-Label Phase)|Emergence of mania is defined as first occurrence of score of >=15 in the YMRS total score in the Open-Label Extension. The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.|Baseline (End of Acute Phase/Week 6) through Endpoint (Week 24)|Total participants in the open-label extension phase.||percentage of participants|||Number
744789|NCT00510146|Secondary|Change From Baseline to Endpoint in Young Mania Rating Scale (YMRS) Total Score (Open-Label Phase)|The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.|Baseline (End of Acute Phase/Week 6), Endpoint (Week 24)|Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
744790|NCT00510146|Secondary|Percentage of Participants With Recovery (Open-Label Phase)|Percentage of participants with recovery defined as a value of less than or equal to 12 in the MADRS total score for at least 4 weeks of post-baseline treatment. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline (End of Acute Phase/Week 6) through Endpoint (Week 24)|Total participants in open-label extension phase.||percentage of participants|||Number
744791|NCT00510146|Secondary|Percentage of Participants With Symptomatic Remission in the MADRS Total Score (Open-Label Phase)|Percentage of participants with symptomatic remission at any time as defined as a score of less than or equal to 12 in the MADRS total score. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline (End of Acute Phase/Week 6) through Endpoint (Week 24)|Total participants in open-label extension phase.||percentage of participants|||Number
744792|NCT00510146|Secondary|Percentage of Participants With Symptomatic Response in Montgomery-Asberg Depression Rating (MADRS) Depression Rating (Open-Label Phase)|The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Response is defined as a reduction (from baseline to endpoint) of 50% or more in the MADRS total score.|Baseline (End of Acute Phase/Week 6) through Endpoint (Week 24)|Total participants in the open-label extension phase.||percentage of participants|||Number
744793|NCT00510146|Secondary|Number of Participants With Adverse Events (Acute Phase)|Please refer to the Adverse Event overview for details regarding adverse events and serious adverse events.|Baseline through Week 6 (Acute Phase)|All enrolled participants in Acute Phase||participants|||Number
744794|NCT00510146|Secondary|Change From Baseline to Endpoint in MINI Suicidality Total Scores (Acute Phase)|The MINI module C (MINI-C) is a rating scale for severity of suicidal thoughts and behaviors. The MINI-C is composed of 12 Yes/No questions with variable scores assigned to each question. The scale ranges from 0 to 52 with higher scores indicating a greater presence of suicidal thoughts and/or behaviors.|Baseline, Endpoint (Week 6)|Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
744795|NCT00510146|Secondary|Change From Baseline to Endpoint in Heart Rate (Acute Phase)||Baseline, Endpoint (Week 6)|Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||beats per minute (bpm)||Standard Deviation|Mean
744796|NCT00510146|Secondary|Change in Electrocardiogram (ECG) From Baseline to Endpoint (Acute Phase)|Time from electrocardiogram Q wave to the end of the T wave corresponding to electrical systole, fixed correction factor (QTcF interval); Bazett-Corrected QT Interval (QTcB interval).|Baseline, Endpoint (Week 6)|Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||milliseconds||Standard Deviation|Mean
744797|NCT00510146|Secondary|Change From Baseline to Endpoint in Urinalysis (UA)- Specific Gravity (Acute Phase)||Baseline, Endpoint (Week 6)|Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||ratio||Standard Deviation|Mean
744798|NCT00510146|Secondary|Change From Baseline to Endpoint in Prolactin (Acute Phase)||Baseline, Endpoint (Week 6)|Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||microgram/Liter||Standard Deviation|Mean
744799|NCT00510146|Secondary|Change From Baseline to Endpoint in Hemoglobin (Acute Phase)||Baseline, Endpoint (Week 6)|Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||millimole/Liter of iron (Fe)||Standard Deviation|Mean
744800|NCT00510146|Secondary|Change From Baseline to Endpoint in Hemoglobin A1c (Acute Phase)||Baseline, Endpoint (Week 6)|Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||percent of glycosylated hemoglobin||Standard Deviation|Mean
744801|NCT00510146|Secondary|Change From Baseline to Endpoint in Hematocrit (Acute Phase)||Baseline, Endpoint (Week 6)|Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||proportion of blood volume||Standard Deviation|Mean
744802|NCT00510146|Secondary|Change From Baseline to Endpoint in Erythrocyte Count (Acute Phase)||Baseline, Endpoint (Week 6)|Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||trillion cells per liter ( TRIL/L)||Standard Deviation|Mean
744803|NCT00510146|Secondary|Change From Baseline to Endpoint in Direct Bilirubin, Total Bilirubin, Uric Acid (Acute Phase)||Baseline, Endpoint (Week 6)|Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||micromole/Liter||Standard Deviation|Mean
744804|NCT00510146|Secondary|Change From Baseline to Endpoint in Alanine Amino Transferase/Serum Glutamate Pyruvate Transaminase (ALT/SGPT), Aspartate Aminotransferase/Serum Glutamic Oxaloacetic Transaminase (AST/SGOT), Gamma Glutamyl Transferase (GGT)||Baseline, Endpoint (Week 6)|Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||units/Liter||Standard Deviation|Mean
744805|NCT00510146|Secondary|Change From Baseline to Endpoint in Albumin (Acute Phase)||Baseline, Endpoint (Week 6)|Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||gram/Liter||Standard Deviation|Mean
744806|NCT00510146|Secondary|Change From Baseline to Endpoint in Glucose and Lipids (Cholesterol, Triglycerides, HDL Cholesterol, LDL Cholesterol)||Baseline, Endpoint (Week 6)|Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||millimole/Liter||Standard Deviation|Mean
744807|NCT00510146|Secondary|Change From Baseline to Endpoint in Weight (Acute Phase)||Baseline, Endpoint (Week 6)|Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||kilograms||Standard Deviation|Mean
744808|NCT00510146|Secondary|Change From Baseline to Endpoint in Blood Pressure (Acute Phase)||Baseline, Endpoint (Week 6)|Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||mmHg (millimeters of mercury)||Standard Deviation|Mean
744809|NCT00510146|Secondary|Percentage of Participants With Extra-Pyramidal Symptoms (EPS) At Endpoint As Measured by Drug-Induced Extra-Pyramidal Symptoms Scale (DIEPSS) (Acute Phase)|EPS symptoms measured by DIEPSS are grouped into 4 categories: parkinsonism, akathisia, dystonia, and dyskinesia. Severity is assessed at 5 levels, from level 0 (none, normal) to level 4 (severe). For Parkinsonism, normal baseline is defined as a score not >=3 on 1 item nor >=2 on 2 items; abnormal endpoint is defined as a score >=3 on 1 item or >=2 on 2 items, or an increase of 3 on Parkinsonism total. Baseline akathisia, dystonia and dyskinesia is defined as a score <2; abnormal endpoint is a score >=2 or an increase >= 2 from that baseline score.|Endpoint (Week 6)|Participants with a normal baseline and an endpoint result.||percentage of participants|||Number
744810|NCT00510146|Secondary|Percentage of Participants With Emergence of Mania During the Study (Acute Phase)|Emergence of mania is defined as first occurrence of score of >=15 in the YMRS total score in the post-baseline period of Acute Phase. The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.|Baseline through Endpoint (Week 6)|Intention-to-treat (ITT) population||percentage of participants|||Number
745017|NCT00511797|Secondary|Number of Bleeding / Spotting Days|Bleeding data were captured from the diary a participant recorded by herself. Bleeding is a genital bleeding. Spotting is a slight genital bleeding with participant's experience. The bleeding /spotting analyses are by intensity.|For the first 90 days|FAS (Participants with the defined data)||days||Standard Deviation|Mean
744811|NCT00510146|Secondary|Percentage of Participants With Non-Alcohol Psychoactive Substance Use Disorder at Endpoint on MINI Substance Dependence/Abuse Module (Acute Phase)|In the MINI Substance Dependence and Abuse Module, participants are asked a series of Yes/No questions to determine whether or not they are currently experiencing symptoms indicating current non-alcohol substance use dependence or abuse.|Endpoint (Week 6)|Intention-to-treat (ITT) population with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||percentage of participants|||Number
744812|NCT00510146|Secondary|Percentage of Participants With Alcohol Dependence and Abuse at Endpoint on MINI Alcohol Dependence/Abuse Module (Acute Phase)|In the MINI Alcohol Abuse and Dependence Module, participants are asked a series of Yes/No questions to determine whether or not they are currently experiencing symptoms indicating current alcohol dependence or abuse.|Endpoint (Week 6)|Intention-to-treat (ITT) population with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||percentage of participants|||Number
744813|NCT00510146|Secondary|Percentage of Participants With Psychotic Disorders and Mood Disorders With Psychotic Features at Endpoint on MINI Psychotic Disorders Module (Acute Phase)|In the MINI Psychotic Features Episode module, participants are asked a series of Yes/No questions to determine whether or not they are currently experiencing mood disorder with psychotic features or current psychotic disorders.|Endpoint (Week 6)|Intention-to-treat (ITT) population with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||percentage of participants|||Number
744814|NCT00510146|Secondary|Percentage of Participants With Current Hypomanic Episode at Endpoint on MINI Manic Episode Module (Acute Phase)|In the MINI Manic Episode module, participants are asked a series of Yes/No questions to determine whether or not they are currently experiencing hypomanic or manic episodes.|Endpoint (Week 6)|Intention-to-treat (ITT) population with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||percentage of participants|||Number
744815|NCT00510146|Secondary|Percentage of Participants With Major Depressive Episode at Endpoint on Mini International Neuropsychiatric Interview (MINI), Depressive Episode Module (Acute Phase)|In the MINI Major Depressive Episode module, participants are asked a series of Yes/No questions to determine whether or not they are experiencing a major depressive episode or a major depressive episode with melancholic features.|Endpoint (Week 6)|Intention-to-treat (ITT) population with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||percentage of participants|||Number
744816|NCT00510146|Secondary|Change From Baseline to Endpoint in Hamilton Depression Rating Scale-17 (HAMD-17) Total Score (Acute Phase)|The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).|Baseline, Endpoint (Week 6)|Intention-to-treat population (ITT) with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF)||units on a scale||Standard Deviation|Mean
744817|NCT00510146|Secondary|Change From Baseline to Endpoint in Young Mania Rating Scale (YMRS) Total Score (Acute Phase)|The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.|Baseline, Endpoint (Week 6)|Intention-to-treat population (ITT) with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF)||units on a scale||Standard Deviation|Mean
744818|NCT00510146|Secondary|Percentage of Participants With Recovery (Acute Phase)|Percentage of participants with recovery defined as a value of less than or equal to 12 in the MADRS total score for at least 4 weeks of post-baseline treatment. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline through Endpoint (Week 6 )|Intention-to-treat (ITT) population; all randomized participants.||percentage of participants|||Number
744819|NCT00510146|Secondary|Change From Baseline to Endpoint in Clinical Global Improvement- Bipolar (CGI-BP) Severity of Illness Scores-Mania, Depression, Overall Bipolar Illness Scores (Acute Phase)|CGI-BP is a measure of illness severity especially adapted for bipolar illness. It allows rating of mania, depression, and overall illness. The score ranges from 1 (normal, not ill) to 7 (very seriously ill).|Baseline, Endpoint (Week 6)|Intention-to-treat population (ITT) with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF)||units on a scale||Standard Deviation|Mean
744820|NCT00510146|Secondary|Percentage of Participants With Symptomatic Remission At Any Time (Acute Phase)|Percentage of participants with symptomatic remission at any time as defined as a score of less than or equal to 12 in the MADRS total score. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline through Endpoint (Week 6)|Intention-to-treat (ITT) population; all randomized participants.||percentage of participants|||Number
744821|NCT00510146|Secondary|Percentage of Participants With Symptomatic Response at Endpoint (Acute Phase)|Response is defined as a reduction (from baseline to endpoint) of 50% or more in the MADRS total score. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Endpoint (Week 6)|Intention-to-treat (ITT) population; all randomized participants.||percentage of participants|||Number
744822|NCT00510146|Primary|Change From Baseline to Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (Acute Phase)|The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline, Endpoint (Week 6)|Intention-to-treat population (ITT) with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF)||units on a scale||Standard Deviation|Mean
749182|NCT00541658|Secondary|Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 52, ITT Population||Week 52|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
744823|NCT00510484|Secondary|Percentage of Days With no Abdominal Pain.|The percentage of days with no abdominal pain is calculated from the diary during the treatment period: 100*(number of days with no abdominal pain / number of days recorded in diary). Higher values indicate a better response.|5 days|The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.||Percentage of days||Standard Deviation|Mean
744824|NCT00510484|Secondary|Percentage of Days With no Flatulence.|The percentage of days with no flatulence is calculated from the diary during the treatment period: 100*(number of days with no flatulence/number of days recorded in diary). Higher values indicate a better response.|5 days|The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.||Percentage of days||Standard Deviation|Mean
744825|NCT00510484|Other Pre-specified|Percentage of Days With Formed/Normal Stools.|The percentage of days with formed/normal stools is calculated from the diary during the treatment period: 100*(number of days with formed/normal stools/number of days with any stool). Higher values indicate a better response.|5 days|The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.||Percentage of days||Standard Deviation|Mean
744826|NCT00510484|Secondary|Stool Frequency|Stool frequency is the average of the daily number of stools recorded during the treatment period. Lower values indicate a better response.|5 days|The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.||Number per day||Standard Deviation|Mean
744827|NCT00510484|Secondary|Total Stool Weight (Grams)|Total weight of the stools collected during the stool collection period. Stools were collected on 3 days during the 5 days treatment period. Lower values indicate a better response.|5 days|The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.||Grams||Standard Deviation|Mean
744828|NCT00510484|Secondary|Total Fat Excretion (Grams)|Total amount of fat excreted during the stool collection period. Stools were collected on 3 days during the 5 days treatment period. Lower values indicate a better response.|5 days|The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.||Grams||Standard Deviation|Mean
744829|NCT00510484|Secondary|Coefficient of Nitrogen Absorption (%)|This coefficient is calculated from nitrogen intake and nitrogen excretion : 100*[nitrogen intake-nitrogen excretion]/nitrogen intake. Stools were collected on 3 days during the 5 days treatment period. Higher values indicate a better response.|5 days|The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.||Percentage||Standard Deviation|Mean
744830|NCT00510484|Primary|Coefficient of Fat Absorption (%)|This coefficient is calculated from fat intake and fat excretion : 100*[fat intake-fat excretion]/fat intake. Stools were collected on 3 days during the 5 days treatment period. Higher values indicate a better response.|5 days|The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.||Percentage||Standard Deviation|Mean
744831|NCT00510497|Secondary|Virologic Efficacy (HIV-1 Viral Load at End of ATI Minus Viral Load Prior to ART)|Log10 Change in HIV RNA set point comparing pre-ART to 12 weeks after treatment interruption|at the end of 12 weeks treatment interruption|||log10 HIV RNA||Full Range|Median
744832|NCT00510497|Primary|Safety and Tolerability of Autologous HIV-1 ApB DC Vaccine.|AE graded by Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, version 1.0, December 2004|80 weeks|||participants with Grade 3 events related|||Number
744833|NCT00510510|Secondary|Least Squares Means of Trough Forced Expiratory Volume in One Second (FEV1), by Day|Forced expiratory volume maneuvers recorded using a calibrated spirometer. Trough forced expiratory volume in one second (FEV1) on Days 1 & 28 defined as the mean of the FEV1 values measured at 23 hours 15 minutes and 23 hours 45 minutes post-dose.|28 Days|||Liters||Standard Error|Least Squares Mean
744834|NCT00510510|Primary|Safety of Treatment With NVA237 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)|The assessment of safety was based on adverse events, particularly those adverse events known to be associated to treatment with muscarinic antagonists. A summary of adverse events is presented with this outcome, additional details are provided in Adverse Events Sections.|28 days|||Participants|||Number
744835|NCT00510653|Primary|Overall Response Rate (ORR)|ORR = participant proportion with responsive disease: Complete Response (CR): disappearance all clinically detectable malignant disease for at least 4 weeks, no new lesions; Partial Response (PR): >/= 50% decrease sum of products of perpendicular diameters of all measurable lesions for at least 4 weeks; Stable Disease: does not qualify for CR, PR or progression. Progressive Disease: a 25% or > increase in sum of products of measurable lesions over smallest sum observed, OR reappearance of lesion which had disappeared, OR appearance of new lesion/site. Response determined every 6 week cycle.|6 weeks with re-evaluation every 6 weeks or until disease progression|Two participants were not evaluable for response: in 1 participant, early toxicity caused discontinuation of the drug, and the other patient had an intestinal obstruction requiring palliative surgery after 1 day of therapy.||participants|||Number
744836|NCT00510692|Secondary|Number of Subjects With Adverse Events.|Incidence of adverse events in each treatment group.|6 months compared to baseline|||participants|||Number
744837|NCT00510692|Secondary|Relative EPA Concentration of Total Free Fatty Acids in the Rectal Mucosa.|Relative EPA concentration of total free fatty acids in the rectal mucosa of subjects with FAP.|6 months compared to baseline.|3 subjects in the full analysis set had no samples for analysis.||percentage of total fatty acid content||95% Confidence Interval|Mean
744838|NCT00510692|Secondary|Change in Global Rectal Polyp Burden.|"Change in global rectal polyp burden in subjects treated with Eicosapentanoic Acid (EPA) compared to subjects receiving placebo. Each reviewer in the Polyp Video Scoring Committee assessed global colorectal polyp burden change as better, same as or worse. The qualitative assessment was assigned a score of +1 for better, 0 for same as and -1 for worse. Thereafter a mean overall reviewers score was calculated."|6 months compared to baseline.|5 subjects in the full analysis set lacked the video required for determining global rectal polyp burden due to failure of equipment.||units on a scale||95% Confidence Interval|Mean
745107|NCT00512902|Secondary|Change in TLC (Total Lung Capacity)|No measures of dispersion was available for TLC as data were lost. This describes the total lung capacity as a percent of predicted.|Baseline vs. Endpoint (1 year)|||Percent predicted||Standard Deviation|Mean
744839|NCT00510692|Secondary|Percentage Change in the Number of Polyps Measured in the Defined Focal Area of the Rectum.|Percentage change in the number of polyps measured in the defined focal area of the rectum in subjects treated with EPA compared to subjects receiving placebo.|6 months compared to baseline.|13 subjects lacked the photographs required for counting the measurements of polyps. Reasons for lack of photographs varied including failure of video equipment, inability to identify identical views of the focal area and no forceps visible for calibration.||percentage of change in total polyps||95% Confidence Interval|Mean
744840|NCT00510692|Primary|Absolute Change in the Number of Polyps Measured in a Focal Area of the Rectum.|Absolute change in the number of polyps measured in a defined focal area of the rectum.|6 months compared to baseline.|13 subjects lacked the photographs required for counting the measurements of polyps. Reasons for lack of photographs varied including failure of video equipment, inability to identify identical views of the focal area and no forceps visible for calibration.||Change from baseline number of polyps.||Standard Deviation|Mean
744841|NCT00510744|Primary|Fat Absorption|72 hour fat absorption study|3 months|each patients as their own control, baseline fat absorption vs post 3 month enzyme supplementation fat absorption||g/d||Standard Error|Mean
744842|NCT00510783|Primary|Number of Participants Who Experienced a Recurrent Seizure After Treatment.|Recurrent seizure is defined as a seizure within 24 hours of treatment in the Emergency Department.|24 hours|||participants|||Number
744843|NCT00510809|Secondary|Adverse Events Reported|All events reported that were deemed to be related, or unrelated, to the study drug.|Week 8|||number of events reported|||Number
744844|NCT00510809|Primary|Lipid Profile||Change between Week 8 and Baseline|||mg/dl||Standard Error|Mean
744845|NCT00510835|Secondary|Resource Use and Costs of Alternative Resuscitation Strategies||at discharge or 60 days, whichever comes first||||||
744846|NCT00510835|Secondary|Changes in Markers of Inflammation, Oxidative Stress, Cellular Hypoxia and Coagulation/Thrombosis.||study hour 0, 6, 24 & 72||||||
744847|NCT00510835|Primary|Hospital Mortality|The primary study outcome is hospital mortality (defined as the number of deaths prior to discharge or 60 days, whichever comes first). The secondary outcomes are duration of survival (90 day and 1 year) and clinical evidence of organ dysfunction.|prior to discharge or 60 days, whichever comes first|||Participants|||Count of Participants
744848|NCT00510874|Secondary|Number of Seroprotected Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.|A seroprotected subject was defined as a vaccinated subject who had a serum HI antibody reciprocal titer ≥ 1:40 on the specified study day.|At Days 0, 21 and 182|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and Day 42 HI titer results for the A/Indonesia/5/05 virus.||Subjects|||Number
744849|NCT00510874|Secondary|Geometric Mean Fold-rise (GMFR) Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.|GMFR was defined as the geometric mean fold increase in serum HI antibody reciprocal titer on the specified study day compared to Day 0.|At Days 21 and 182|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and Day 42 HI titer results for the A/Indonesia/5/05 virus.||Fold increase||95% Confidence Interval|Geometric Mean
744850|NCT00510874|Secondary|Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer on the specified day.|At Days 21 and 182|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and Day 42 HI titer results for the A/Indonesia/5/05 virus.||Subjects|||Number
744851|NCT00510874|Secondary|Titers for Serum HI Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.|Titers are presented as geometric mean titers (GMTs).|At Day 21 and Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and Day 42 HI titer results for the A/Indonesia/5/05 virus.||Titers||95% Confidence Interval|Geometric Mean
744852|NCT00510874|Primary|Number of Subjects With Any Serious Adverse Events (SAEs).|A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or resulted in a congenital anomaly/birth defect in the offspring of a study subject.|From Day 0 to 182|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.||Subjects|||Number
744853|NCT00510874|Primary|Number of Subjects With Unsolicited Adverse Events (AEs).|An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Between Day 0 and Day 84 after vaccination.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.||Subjects|||Number
744854|NCT00510874|Primary|Number of Subjects With Unsolicited Adverse Events (AEs).|An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 21-day follow-up period (Days 0-20) after vaccination.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.||Subjects|||Number
753200|NCT00566982|Primary|Mean Change From Baseline in Percentage of Superficial Cells in Maturation Index of Vaginal Smear||12 weeks|ITT||percentage of superficial cells||Standard Deviation|Mean
744855|NCT00510874|Primary|Number of Subjects With Medically Attended Adverse Events (MAEs) and New Onset Chronic Diseases (NOCDs).|A MAE was defined as any unsolicited symptom that received medical attention such as hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. NOCDs included autoimmune diseases, diabetes mellitus.|From Day 0 to 182|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.||Subjects|||Number
744856|NCT00510874|Primary|Number of Subjects With Solicited General Symptoms.|Assessed solicited general symptoms were fatigue, headache, joint pain at other location (joint pain), muscle aches, shivering, sweating and fever. Fever was defined as oral temperature (≥) 38 degrees Celsius (°C). Any = occurrence of any solicited general symptoms regardless of intensity grade or relationship to vaccination.|Within the 7-day follow-up period (Days 0-6) after any vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.||Subjects|||Number
744857|NCT00510874|Primary|Number of Subjects With Solicited Local Symptoms.|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any solicited local symptoms regardless of their intensity grade. Any redness and swelling were ≥ 20 millimeters (mm).|Within the 7-day follow-up period (Days 0-6) after any vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.||Subjects|||Number
744858|NCT00510874|Primary|Number of Seroprotected Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.|A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40.|At Day 42|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and Day 42 HI titer results for the A/Indonesia/5/05 virus.||Subjects|||Number
744859|NCT00510874|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.|Titers are presented as geometric mean titers (GMTs).|At Day 42|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and Day 42 HI titer results for the A/Indonesia/5/05 virus.||Titers||95% Confidence Interval|Geometric Mean
744860|NCT00510874|Primary|Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer on the specified day.|At Day 42|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and Day 42 HI titer results for the A/Indonesia/5/05 virus.||Subjects|||Number
744861|NCT00510887|Secondary|Number of Participants With Neuropathy, Any Grade|Before each drug dose, the patient will be evaluated for possible toxicities that may have occurred after the previous dose(s). Toxicities are to be assessed according to the NCI Common Toxicity Criteria (CTC).|up to 1 year|||participants|||Number
744862|NCT00510887|Secondary|Number of Participants With a Grade 3-4 Hematologic Toxicity.|Before each drug dose, the patient will be evaluated for possible toxicities that may have occurred after the previous dose(s). Toxicities are to be assessed according to the NCI Common Toxicity Criteria (CTC).|up to 1 year|||participants|||Number
744863|NCT00510887|Secondary|Percentage of Subjects Experiencing Overall Survival|Overall survival is from the day of enrollment to date of death from any cause.|up to 2 years|||percentage of participants|||Number
744864|NCT00510887|Secondary|Percentage of Subjects Experiencing Progression Free Survival|Progression free survival is measured from treatment to progression or death, whichever comes first. Progressive disease is measured as: 50% or greater increase from nadir in the sum of the products (SPD) of any previously identified abnormal node and the appearance of any new lesions during or at the end of treatment.|up to 2 years|||percentage of participants|||Number
744865|NCT00510887|Secondary|Duration of Response|Duration of response is measured from time of treatment to time of disease progression|up to 4 years|||months||Full Range|Mean
744866|NCT00510887|Primary|Complete and Partial Response|"Complete Response: Complete disappearance of all detectable clinical and radiographic evidence of disease, disappearance of all disease-related symptoms and normalization of biochemical abnormalities (eg. LDH) definitely assignable to follicular lymphoma.
Partial Response requires the following:
greater than or equal to 50% decrease in the SPD of the 6 largest dominant nodes of nodal masses.
No increase in size of other nodes, liver, or spleen.
Splenic and hepatic nodes must regress by at least 50% in sum of the products (SPD).
Bone marrow assessment in irrelevant for determination of Partial Response since it is not measurable disease; however, if positive the type of cell should be reported.
No new lesions."|1 year|||percentage of participants|||Number
744867|NCT00510952|Secondary|Total Daily Insulin Dose Per Body Weight (Units/Kilograms) at Endpoint|Insulin dose at endpoint was analyzed by 24-hour total daily insulin per body weight (units/kilograms).|24 Weeks|Number of randomized patients who received at least one dose of study drug and had at least one post-baseline measurement. Last observation carried forward.||Units of insulin/kilograms (U/kg)||Standard Deviation|Mean
744868|NCT00510952|Secondary|Total Daily Insulin Dose (Units) at Endpoint|Insulin dose at endpoint was analyzed by 24-hour total daily insulin (units).|24 weeks|Number of randomized patients who received at least one dose of study drug and had at least one post-baseline measurement. Last observation carried forward.||Units of insulin||Standard Deviation|Mean
744869|NCT00510952|Secondary|Change in Absolute Body Weight (kg) From Baseline to 24 Week Endpoint||Baseline, 24 weeks|Number of randomized patients who received at least one dose of study drug and had at least one post-baseline measurement.||kilograms (kg)||Standard Deviation|Mean
745108|NCT00512902|Secondary|Change in FVC (Forced Vital Capacity)|Measures the amount of air breathed out as a percent of predicted.|Baseline vs. Endpoint (1 year)|||Percent predicted||Standard Deviation|Mean
745109|NCT00512902|Primary|Treatment-related Adverse Events|Treatment-related adverse events requiring discontinuation.|Baseline vs. Endpoint (1 year)|||participants|||Number
744870|NCT00510952|Secondary|30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall|Overall: any time after randomization. Hypoglycemic: any time patient experienced sign/symptom associated with hypoglycemia, or had old Roche blood glucose level <7 mg/dL. Nocturnal: any hypoglycemic event that occurred between bedtime and waking. Severe: event with symptoms consistent with neuroglycopenia in which patient requires assistance, and is associated with: a Roche blood glucose value <2.8 mmol/L or prompt recovery after oral carbohydrate, glucagon, or IV glucose. 30-day adjusted rate=(total number of episodes between 2 time intervals/number of days between intervals) X 30 days.|Baseline to 24 Weeks|Number of randomized patients who received at least one dose of study drug and had at least one post-baseline measurement.||hypoglycemic events per 30 days||Standard Deviation|Mean
744871|NCT00510952|Secondary|1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall|Overall: any time after randomization. Hypoglycemic: any time patient experienced sign/symptom associated with hypoglycemia, or had old Roche blood glucose level <7 mg/dL. Nocturnal: any hypoglycemic event that occurred between bedtime and waking. Severe: event with symptoms consistent with neuroglycopenia in which patient requires assistance, and is associated with: a Roche blood glucose value <2.8 mmol/L or prompt recovery after oral carbohydrate, glucagon, or IV glucose. 1-year adjusted rate=(total number of episodes between 2 time intervals/number of days between intervals) X 365.25 days.|Baseline to 24 weeks|Number of randomized patients who received at least one dose of study drug and had at least one post-baseline measurement.||hypoglycemic event per 1 year||Standard Deviation|Mean
744872|NCT00510952|Secondary|Number of Participants With Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe Hypoglycemia) Overall|Overall: any time after randomization. Hypoglycemic: any time patient experienced sign/symptom associated with hypoglycemia, or had old Roche blood glucose level <7 mg/dL. Nocturnal: any hypoglycemic event that occurred between bedtime and waking. Severe Hypoglycemia: event with symptoms consistent with neuroglycopenia in which patient requires assistance, and is associated with either a Roche blood glucose value <2.8 millimoles/liter or prompt recovery after oral carbohydrate, glucagon, or intravenous glucose.|Baseline to 24 weeks|Number of randomized patients who received at least one dose of study drug and had at least one post-baseline measurement.||participants|||Number
744873|NCT00510952|Secondary|7-Point Self-Monitored Blood Glucose (SMBG) Profile at Endpoint|Actual measurements and daily mean blood glucose levels at endpoint.|24 weeks|Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement. Last observation carried forward.||millimoles per liter (mmol/L)||Standard Deviation|Mean
744874|NCT00510952|Secondary|Glycemic Variability at Endpoint|Glycemic variability was measured by standard deviation (SD) value of fasting blood glucose as measured by intra-patient glycemic variability (determined by the 7-point self-monitoring blood glucose (SMBG) profiles at endpoint) based on the actual morning pre-meal blood glucose.|24 weeks|Number of randomized patients who received at least one dose of study drug and had at least one post-baseline measurement. Last observation carried forward.||millimoles per liter (mmol/L)||Standard Deviation|Mean
744875|NCT00510952|Secondary|Percentage of Patients With HbAlc Less Than 7.0 Percent and HbAlc Less Than or Equal to 6.5 Percent at Endpoint|Percentage of patients achieving Hemaglobin A1c (HbA1c) targets of less than 7% and less than or equal to 6.5% at endpoint.|24 weeks|Number of randomized patients who received at least one dose of study drug and had at least one post-baseline measurement. Last observation carried forward.||percentage of participants|||Number
744876|NCT00510952|Secondary|Actual and Change From Baseline to 12 Week and 24 Week Endpoint in HbAlc Value||Baseline, 12 Weeks, 24 Weeks|Number of randomized patients who received at least one dose of study drug and had at least one post-baseline measurement.||percent hemoglobin||Standard Error|Least Squares Mean
744877|NCT00510952|Primary|Change From Baseline to 24 Week Endpoint in Hemoglobin A1c (HbA1c)||Baseline, 24 Weeks|Number of randomized patients who received at least one dose of study drug and had at least one post-baseline measurement. Last observation carried forward.||percent of HbA1c||Standard Error|Least Squares Mean
744878|NCT00511004|Secondary|Brugia Specific Immunoglobulin G4 (IgG4) Antibodies|IgG4 antibodies directed against Brugia malayi antigen|2 years|By 2 years, 4 subjects in High Dose Group lost to followup||ng/ml||Full Range|Median
744879|NCT00511004|Secondary|Microfilarial Levels at 2 Years|Night time microfilarial levels at 2 years|2 years from time enrolled|By 2 years, 4 subjects in High Dose Group lost to followup||MF/ML||Full Range|Median
744880|NCT00511004|Secondary|Adult Worm Burdens at 2 Years|Doppler detected worm nests at 2 years|2 years from the time enrolled.|By 2 years, 4 subjects in High Dose Group lost to followup||Number of nests||Full Range|Median
744881|NCT00511004|Primary|Microfilarial Counts at 1 Year|Night time microfilarial counts at 1 year|1 year from time enrolled|||MF/ML||Full Range|Median
744882|NCT00511095|Secondary|Serum GMC of Anti-HBsAg Measured at Weeks 4, 8, 12, and 28||28 Weeks|||mIU/mL||95% Confidence Interval|Geometric Mean
744883|NCT00511095|Secondary|Portion of Subjects Who Have a Seroprotective Immune Response (Anti-HBsAg ≥ 10 Milli-international Unit (mIU)/ml) at Weeks 4, 8, 12 and 28.||28 weeks|Enrolled subjects who received at least 1 study injection irrespective of available immune response data.||Participants|||Count of Participants
744884|NCT00511095|Primary|Occurrence of Adverse Events and Local and Systemic Reaction Rates||8 weeks|Subject who received at least 1 study injection (confirm)||Participants|||Count of Participants
744885|NCT00511108|Secondary|Change From Baseline in Glucose 5-hour Total AUC After 12 Weeks of Treatment|Glucose concentration was measured at 11 points during an Meal Tolerance Test (MTT), at times -10, 0, 10, 20, 30, 60, 90, 120, 180, 240, 300 minutes. Total AUC was calculated over 5 hours including all sample points starting from 0 minutes using the trapezoid method. The change from baseline reflects Week 12 total AUC minus the Week 0 total AUC.|Baseline and 12 weeks|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. For FAS patients with no data at Week 12, the last observed measurement was carried forward to Week 12.||mg*hr/dL||95% Confidence Interval|Least Squares Mean
744939|NCT00511355|Primary|Serum Concentration of Corticosteroid Binding Globulin (CBG)|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline to Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||nmol/L||Standard Deviation|Mean
744886|NCT00511108|Primary|Percent Change From Baseline in Index of Static Beta-cell Sensitivity to Glucose After 12 Weeks of Treatment|"Static sensitivity is a measure of the effect of glucose on beta cell secretion and is the ratio between the insulin secretion rate and glucose concentration above the threshold level at steady state.
Percent change from baseline was calculated as the difference between index of static sensitivities at Week 12 and at baseline with respect to the index of static sensitivity at baseline times 100."|Baseline and 12 weeks|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. For FAS patients with no data at Week 12, the last observed measurement was carried forward to Week 12.||Percent Change||95% Confidence Interval|Least Squares Mean
744887|NCT00511108|Primary|Change From Baseline in Glucagon 3-hour Total Area Under the Curve (AUC) After 12 Weeks of Treatment|Glucagon concentration was measured at 9 points during an Meal Tolerance Test (MTT), at times -10, 0, 10, 20, 30, 60, 90, 120, and 180 minutes. Total AUC was calculated over 3 hours including all sample points starting from 0 minutes using the trapezoid method. The change from baseline reflects Week 12 total AUC minus the Week 0 total AUC.|Baseline and 12 weeks|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. For FAS patients with no data at Week 12, the last observed measurement was carried forward to Week 12.||pg*hr/mL||95% Confidence Interval|Least Squares Mean
744888|NCT00511134|Secondary|Smoking Abstinence as Measured by Self Reported Smoking and Confirmed by CO Level|Endpoint abstinence will be defined as 0 cigarettes over the seven days prior to the subject’s Timeline Follow-Back evaluation at the end of week 7 (end of trial) and a Carbon Monoxide (CO) level ≤ 5.|6 weeks after target smoking quite date|||participants|||Number
744889|NCT00511134|Primary|Level of Insomnia as Measured by the Insomnia Severity Index|Insomnia Severity Index (ISI): 13-item self-report measure which examines symptoms of insomnia, consequences of insomnia, and subjective distress related to sleep problems. Subjects rate the symptoms and consequences of insomnia on a 5 point Likert scales. For example, subjects are asked to rate the severity of their insomnia (e.g., difficulty falling asleep from 0=none to 4=very severe). Scores on the first 7 items are summed for a total insomnia score ranging from 0-28.|6 weeks after target smoking quit date|Baseline descriptive data was examined for the 4 participants. Outcome measures were available for 2 participants. Due to the small number of participants, statistical comparisons were not able to be performed.||Units on a Scale||Full Range|Median
744890|NCT00511147|Secondary|Regression of Hemorrhage/Bleedings|Defined by the percentage of treated patients with hemorrhage/bleedings at Day 1 (i.e., the day of the first infusion, pre-infusion) who improve their diathesis during the clinical follow-up period ending on Day 15 ± 1.|15 days|Number of participants analyzed is based on the number of patients with hemorrhage/bleeding at Day 1 in the Modified ITT Population||percent of subjects with regression|||Number
744891|NCT00511147|Secondary|Duration of Response|Defined by the number of consecutive days for which the platelet count remains ≥ 50 x 10^9/L at any moment during the clinical follow-up period ending on Day 30 ± 1.|30 days|Number of participants analyzed is based on the number of responding patients (52/64 [81.3%]) in the Modified ITT Population||days||Standard Deviation|Mean
744892|NCT00511147|Secondary|Time to Platelet Count Recovery|Defined by the number of days elapsed from Day 1 (the day of the first infusion of the IP) to the day when the platelet count is first known to be ≥ 50 x 10^9/L at any moment during the clinical follow-up period ending on Day 30 ± 1|30 days|Number of participants analyzed is based on the number of responding patients (52/64 [81.3%]) in the Modified ITT Population||days||Standard Deviation|Mean
744893|NCT00511147|Primary|Response Rate|Defined by the percentage of treated patients in whom platelet counts increase from ≤ 20 x 10^9/L to ≥ 50 x 10^9/L by Day 8 ± 1 [where the day of the first infusion is Day 1]|8 days|Modified ITT Population||percentage of responders|||Number
744894|NCT00511173|Primary|In Patients Receiving Warfarin, a Pharmacogenetic Algorithm Dose Was Compared to Clinician Dosing (mg/wk).|Warfarin pharmacogenetic algorithm dosing (mg/wk) was compared to clinician warfarin dosing (mg/wk).|six months|power analysis based on data from Sconce, et al.||mg/wk||Standard Deviation|Mean
744895|NCT00511199|Secondary|Average Number of Withdrawal Bleeding/Spotting Days|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Withdrawal bleeding was defined as bleeding/spotting episode that started during or continued into the expected bleeding period. Expected bleeding period: DRSP-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle."|Every 28-day cycle for 13 cycles (one year total)|"ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.
n= number of participants who had withdrawal bleeding/spotting for the respective cycle."||days||Standard Deviation|Mean
744896|NCT00511199|Secondary|Average Number of Breakthrough Bleeding/Spotting Days|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding/spotting was defined as any episode that occurred during the expected non-bleeding period that was neither an early nor a continued withdrawal bleeding. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle."|Every 28-day cycle for 13 cycles (one year total)|"ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.
n= number of participants who had breakthrough bleeding/spotting for the respective cycle."||days||Standard Deviation|Mean
744940|NCT00511355|Primary|Serum Concentration of Total Cortisol|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||nmol/L||Standard Deviation|Mean
745146|NCT00514683|Secondary|Change From Baseline in TLC|Change from Baseline in Total Lung Capacity (TLC) at 52 weeks. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.|Baseline and 52 weeks|LOCF-Randomised set||Liters||Standard Error|Mean
744897|NCT00511199|Secondary|Number of Participants With an Occurrence of Continued Withdrawal Bleeding|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Continued withdrawal bleeding was defined as any withdrawal bleeding that continued into the expected non-bleeding period of the next cycle. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle."|Every 28-day cycle for 12 cycles|The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.||Participants|||Number
744898|NCT00511199|Secondary|Number of Participants With an Occurrence of Early Withdrawal Bleeding|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Early withdrawal bleeding was defined as any withdrawal bleeding that started before the current expected bleeding period. Expected bleeding period: DRSP-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle."|Every 28-day cycle for 13 cycles (one year total)|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.
n= number of participants with evaluable cycles."||Participants|||Number
744899|NCT00511199|Secondary|Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only)|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough spotting was defined as any spotting episode that occurred during the expected non-bleeding period that was neither part of an early nor continued withdrawal bleeding.
Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of
the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle."|Every 28-day cycle for 13 cycles (one year total)|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.
n= number of participants with evaluable cycles."||Participants|||Number
744900|NCT00511199|Secondary|Number of Participants With an Occurrence of Breakthrough Bleeding|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding was defined as any bleeding episode that occurred during the expected non-bleeding period that was neither part of an early nor continued withdrawal bleeding. Expected non-bleeding period: LNG-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle."|Every 28-day cycle for 13 cycles (one year total)|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.
n= number of participants with evaluable cycles."||Participants|||Number
744901|NCT00511199|Secondary|Number of Participants With an Occurrence of Absence of Withdrawal Bleeding|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Absence of withdrawal bleeding was defined as no bleeding/spotting episode that began during or continued into the expected bleeding period. Expected bleeding period: DRSP-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle."|Every 28-day cycle for 13 cycles (one year total)|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.
n= number of participants with evaluable cycles."||participants|||Number
744902|NCT00511199|Secondary|Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding/spotting was defined as any episode that occurred during the expected non-bleeding period that was neither an early nor a continued withdrawal bleeding. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle."|Every 28-day cycle for 13 cycles (one year total)|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.
n= number of participants with evaluable cycles."||participants|||Number
744903|NCT00511199|Primary|Number of In-treatment Pregnancies (With +14 Day Window) Per 100 Woman Years of Exposure (Pearl Index)|In-treatment pregnancies were pregnancies with an estimated date of conception from the day of first intake of trial medication up to and including the day of last (active or placebo) intake of trial medication extended with a period of 14 days. Each 13 cycles (28 days per cycle) of exposure constitutes a woman year. The Pearl Index was obtained by dividing the number of in-treatment pregnancies that occurred by the time (in 100 women years) that the women were under risk of becoming pregnant.|1 year (13 cycles)|Restricted ITT set included all participants treated except for 2 nonpregnant participants whose exposure was excluded due to limited credibility of diary data & also excluded nonpregnant participants without >= 1 cycle expected to be at risk for pregnancy (with recorded use of condoms or w/o confirmed sexual intercourse, based on e-diary data).||Pregnancies per 100 woman years|Participants|95% Confidence Interval|Number
745147|NCT00514683|Secondary|St George's Respiratory Questionnaire (SGRQ) Responder|St George's Respiratory Questionnaire (SGRQ) responder (<= -4 points change) (%) at 52 weeks-worst case|52 weeks|Worst case - Randomised set||percentage of participants|||Number
744904|NCT00511199|Primary|Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index)|In-treatment pregnancies were pregnancies with an estimated date of conception from the day of first intake of trial medication up to and including the day of last (active or placebo) intake of trial medication extended with a maximum of two days. Each 13 cycles (28 days per cycle) of exposure constitutes a woman year. The Pearl Index was obtained by dividing the number of in-treatment pregnancies that occurred by the time (in 100 women years) that the women were under risk of becoming pregnant.|1 year (13 cycles)|Restricted ITT set included all participants treated except for 2 nonpregnant participants whose exposure was excluded due to limited credibility of diary data & also excluded nonpregnant participants without >= 1 cycle expected to be at risk for pregnancy (with recorded use of condoms or w/o confirmed sexual intercourse, based on e-diary data).||Pregnancies per 100 woman years|Participants|95% Confidence Interval|Number
744905|NCT00511238|Secondary|Overall Survival (A1 Only)|The time from start of treatment to death due to any cause OS was to be censored on the date the subject was last known to be alive for those who were alive or lost to follow-up as of a data analysis cutoff date.|Patients were to be followed by telephone contact for disease progression and OS every 3 months after study discontinuation for the first year and every 6 months thereafter for up to 2 years|||months||95% Confidence Interval|Number
744906|NCT00511238|Secondary|Progression-free Survival (A1 Only)|The PFS was defined as the time from the start of treatment to progressive disease (PD) determined by PI or until death.|Response assessments same as described in primary outcome measure|"Response-Evaluable Population:
had measurable disease at Baseline
received at least 1 dose of carfilzomib
underwent baseline disease response assessments and at least 1 post-baseline disease assessment, or discontinued protocol treatment before Cycle 2 Day 1 due to an AE that was considered to be possibly or probably related to carfilzomib"||months||95% Confidence Interval|Median
744907|NCT00511238|Secondary|Progression-free Survival (A0 Only)|The PFS was defined as the time from the start of treatment to progressive disease (PD) determined by PI or until death.|Response assessments same as described in primary outcome measure|Response-evaluable Population: Enrolled patients who completed at least 1 cycle of carfilzomib and who underwent disease assessments at Screening, Cycle 1 Day 15, and Cycle 2 Day 24. This analysis set also included patients who discontinued treatment during this time due to an AE that was considered probably related to carfilzomib.||months||95% Confidence Interval|Median
744908|NCT00511238|Secondary|Time to Progression (A1 Only)|Time to progression (TTP) is defined as the time from the study entry (first dose of carfilzomib) to disease progression.|Response assessments same as described in primary outcome measure|"Response-Evaluable Population:
had measurable disease at Baseline
received at least 1 dose of carfilzomib
underwent baseline disease response assessments and at least 1 post-baseline disease assessment, or discontinued protocol treatment before Cycle 2 Day 1 due to an AE that was considered to be possibly or probably related to carfilzomib"||months||95% Confidence Interval|Median
744909|NCT00511238|Secondary|Time to Progression (A0 Only)|Time to progression (TTP) is defined as the time from the study entry (first dose of carfilzomib) to disease progression.|Response assessments same as described in primary outcome measure|Response-evaluable Population: Enrolled patients who completed at least 1 cycle of carfilzomib and who underwent disease assessments at Screening, Cycle 1 Day 15, and Cycle 2 Day 24. This analysis set also included patients who discontinued treatment during this time due to an AE that was considered probably related to carfilzomib.||months||95% Confidence Interval|Median
744910|NCT00511238|Secondary|Duration of Response (A1 Only)|Duration of response (DOR) was calculated separately for subjects with clinical benefit response or overall response. DOR is defined as the time from first evidence of PR or better (for overall response) and MR or better (for clinical benefit response) to start of disease progression or death.|Response assessments same as described in primary outcome measure|Subjects with overall response within the response-evaluable population were included in the analysis of DOR. See overall analysis population description of response-evaluable population above.||months||95% Confidence Interval|Median
744911|NCT00511238|Secondary|Duration of Response (A0 Only)|Duration of response (DOR) was calculated separately for subjects with clinical benefit response or overall response. DOR is defined as the time from first evidence of PR or better (for overall response) and MR or better (for clinical benefit response) to start of disease progression or death.|Response assessments same as described in primary outcome measure|Subjects with overall response within the response-evaluable population were included in the analysis of DOR. See analysis population description of response-evaluable population above.||days||95% Confidence Interval|Median
744912|NCT00511238|Secondary|Clinical Benefit Response (CBR) (A1 Only)|sCR, CR, VGPR, PR, and minimal response (MR)|Response assessments same as described in primary outcome measure|"Response-Evaluable Population:
had measurable disease at Baseline
received at least 1 dose of carfilzomib
underwent baseline disease response assessments and at least 1 post-baseline disease assessment, or discontinued protocol treatment before Cycle 2 Day 1 due to an AE that was considered to be possibly or probably related to carfilzomib"||participants|||Number
744913|NCT00511238|Secondary|Clinical Benefit Response (CBR) (A0 Only)|sCR, CR, VGPR, PR, and minimal response (MR)|Response assessments same as described in primary outcome measure|Response-evaluable Population: Enrolled patients who completed at least 1 cycle of carfilzomib and who underwent disease assessments at Screening, Cycle 1 Day 15, and Cycle 2 Day 24. This analysis set also included patients who discontinued treatment during this time due to an AE that was considered probably related to carfilzomib.||participants|||Number
744914|NCT00511238|Primary|Best Overall Response Rate (ORR)|For both A0 and A1, to evaluate the best overall response rate (stringent complete response [sCR]+ complete response [CR]+ very good partial response [VGPR]+ partial response [PR]) in patients with multiple myeloma who had previously received bortezomib and either thalidomide or lenalidomide, had relapsed after two or more therapies, and were refractory to the most recently received therapy|A0: Subjects evaluated for disease response on Day 24 of Cycles 2, 4, 6, 9, and 12. Onset of response measured on Day 15 of Cycle 1. A1: Subjects evaluated for disease response on Day 15 of Cycle 1, Day 1 of Cycles 2 through 12 and at End of Study.|Analysis population described in reporting groups below||% of participants w/ PR or better||95% Confidence Interval|Number
745068|NCT00512252|Primary|Phase II Only: Complete Response Rate of AMD3100 + MEC|"Responses were assessed according to the International Working Group Criteria for AML. All patients who received at least one dose of AMD3100 were considered evaluable for response.
Response rate was the rate of complete remission plus complete remission with incomplete blood count recovery (CR + CRi)."|42 days|||percentage of participants|||Number
744915|NCT00511342|Secondary|Average Number of Withdrawal Bleeding-spotting Days|Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary cards. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Withdrawal bleeding was defined as bleeding/spotting episode that started during or continued into the “expected bleeding period”. Expected bleeding period: LNG-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2 group: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle.|Every 28-day cycle for 26 cycles (2 years total)|"ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.
n= number of participants who had breakthrough bleeding/spotting for the respective cycle."||days||Standard Deviation|Mean
744916|NCT00511342|Secondary|Average Number of Breakthrough Bleeding-Spotting Days|Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary cards. Participants documented whether vaginal bleeding was present, and if so, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding/spotting was defined as any bleeding/spotting episode that occurred during the “expected non-bleeding period” that was neither an early nor a continued withdrawal bleeding. Expected non-bleeding period: LNG-EE: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle.|Every 28-day cycle for 26 cycles (2 years total)|"ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.
n= number of participants who had breakthrough bleeding/spotting for the respective cycle."||days||Standard Deviation|Mean
744917|NCT00511342|Secondary|Number of Participants With an Occurrence of Continued Withdrawal Bleeding|Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary cards. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Continued withdrawal bleeding was defined as any withdrawal bleeding that continued into the “expected non-bleeding period” of the next cycle. Expected non-bleeding period: LNG-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle.|Every 28-day cycle for 26 cycles (2 years total) including one week after stopping treatment|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.
n= Number of participants with evaluable cycles."||participants|||Number
744918|NCT00511342|Secondary|Number of Participants With an Occurrence of Early Withdrawal Bleeding|Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary cards. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Early withdrawal bleeding was defined as any withdrawal bleeding that started before the current “expected bleeding period”. Expected bleeding period: LNG-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2 group: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle.|Every 28-day cycle for 26 cycles (2 years total)|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.
n= Number of participants with evaluable cycles."||participants|||Number
744919|NCT00511342|Secondary|Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only)|Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary cards. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough spotting was defined as any spotting episode that occurred during the “expected non-bleeding period” that was neither part of an early nor continued withdrawal bleeding. Expected non-bleeding period: LNG-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle.|Every 28-day cycle for 26 cycles (2 years total)|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.
n= Number of participants with evaluable cycles."||participants|||Number
744920|NCT00511342|Secondary|Number of Participants With an Occurrence of Breakthrough Bleeding|Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary cards. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding was defined as any bleeding episode that occurred during the “expected non-bleeding period” that was neither part of an early nor continued withdrawal bleeding. Expected non-bleeding period: LNG-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle.|Every 28-day cycle for 26 cycles (2 years total)|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.
n= Number of participants with evaluable cycles."||participants|||Number
744921|NCT00511342|Secondary|Number of Participants With an Occurrence of Absence of Withdrawal Bleeding|Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary cards. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Absence of withdrawal bleeding was defined as no bleeding/spotting episode that began during or continued into the “expected bleeding period”. Expected bleeding period: LNG-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2 group: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle.|Every 28-day cycle for 26 cycles (2 years total)|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.
n= Number of participants with evaluable cycles."||participants|||Number
744922|NCT00511342|Primary|Mean Change From Baseline in Z-scores of the Lumbar Spine (L2-L4) and Femoral Neck|BMD was measured by a Dual Energy X-ray Absorptiometry (DEXA) machine. The Z-score measures the distance of the measured BMD value from the appropriate normal age matched population mean value in units of standard deviation of this population. More negative scores indicate less BMD compared to age matched population, & more positive scores indicate higher BMD compared to age matched population. The adjusted mean change from baseline to the after Cycle 26 visit of the Z-scores is estimated using a baseline-adjusted analysis of covariance (ANCOVA).|Baseline and after cycle 26 (2 years)|All-Subjects-Treated (AST) group consisted of all randomized participants who took at least one dose of trial medication. The number of participants in the AST group with a baseline value and a Week 26 value is presented.||score on a scale||Standard Deviation|Mean
744923|NCT00511342|Secondary|Number of Participants With an Occurrence of Breakthrough Bleeding/ Spotting|Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary cards. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding/spotting was defined as any episode that occurred during the “expected non-bleeding period” that was neither an early nor a continued withdrawal bleeding. Expected non-bleeding period: LNG-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle.|Every 28-day cycle for 26 cycles (2 years total)|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.
n= Number of participants with evaluable cycles."||participants|||Number
744924|NCT00511342|Secondary|Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index)|"Contraceptive efficacy parameter of this trial was the Pearl Index. In-treatment pregnancies were pregnancies with an estimated date of conception from
the day of first intake of trial medication up to and including the day of last(active or placebo) intake of trial medication extended with a maximum of two days. Each 13 cycles (28 days per cycle) of exposure constitutes a woman year. The Pearl Index was obtained by dividing the number of in-treatment pregnancies that occurred by the time (in 100 women years) that the women were under risk of becoming pregnant."|2 years (26 cycles)|Restricted Intent-To-Treat (ITT) analysis set included all participants treated, and further excluded non-pregnant participants without at least one cycle expected to be at risk for pregnancy(with recorded use of condoms or without confirmed sexual intercourse, as determined from the electronic diary data).||Pregnancies per 100 woman years|Participants|95% Confidence Interval|Number
744925|NCT00511355|Secondary|Average Number of Withdrawal Bleeding/Spotting Days|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Withdrawal bleeding/spotting was defined as any episode that occurred during the expected bleeding period. Expected bleeding period: NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle; LNG-EE: 7-day period starting on Day 22 of the cycle."|Every 28-day cycle for 6 cycles|"ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.
n=number of participants who had withdrawal bleeding/spotting for the respective cycle."||Days||Standard Deviation|Mean
744926|NCT00511355|Secondary|Average Number of Breakthrough Bleeding/Spotting Days|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding/spotting was defined as any episode that occurred during the expected non-bleeding period that was neither an early nor a continued withdrawal bleeding. Expected non-bleeding period: NOMAC-E2: 21-day period starting on Day 4 of the cycle; LNG-EE: 21-day period starting on Day 1 of the cycle."|Every 28-day cycle for 6 cycles|"ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.
n=number of participants who had breakthrough bleeding/spotting for the respective cycle."||Days||Standard Error|Mean
744927|NCT00511355|Secondary|Number of Participants With an Occurrence of Continued Withdrawal Bleeding|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Continued withdrawal bleeding was defined as any withdrawal bleeding that continued into the expected non-bleeding period of the next cycle. Expected non-bleeding period: NOMAC-E2: 21-day period starting on Day 4 of the cycle; LNG-EE: 21-day period starting on Day 1 of the cycle."|Every 28-day cycle for 5 cycles|The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.||Participants|||Number
744928|NCT00511355|Secondary|Number of Participants With an Occurrence of Early Withdrawal Bleeding|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Early withdrawal bleeding was defined as any withdrawal bleeding that started before the current expected bleeding period. Expected bleeding period: NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle; LNG-EE: 7-day period starting on Day 22 of the cycle."|Every 28-day cycle for 6 cycles|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.
n=number of participants with evaluable cycles."||Participants|||Number
744941|NCT00511355|Primary|Serum Concentration of Hemoglobin Type A1c (HbA1c)|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). HbA1c was determined before glucose loading. Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||Percent of glycosylated hemoglobin||Standard Deviation|Mean
744929|NCT00511355|Secondary|Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only)|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough spotting was defined as any spotting episode that occurred during the expected non-bleeding period that was neither part of an early nor continued withdrawal bleeding. Expected non-bleeding period: NOMAC-E2: 21-day period starting on Day 4 of the cycle; LNG-EE: 21-day period starting on Day 1 of the cycle."|Every 28-day cycle for 6 cycles|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.
n=number of participants with evaluable cycles."||Participants|||Number
744930|NCT00511355|Secondary|Number of Participants With an Occurrence of Breakthrough Bleeding|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding was defined as any bleeding episode that occurred during the expected non-bleeding period that was neither part of an early nor continued withdrawal bleeding. Expected non-bleeding period: NOMAC-E2: 21-day period starting on Day 4 of the cycle; LNG-EE: 21-day period starting on Day 1 of the cycle."|Every 28-day cycle for 6 cycles|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.
n=number of participants with evaluable cycles."||Participants|||Number
744931|NCT00511355|Secondary|Number of Participants With an Occurrence of Absence of Withdrawal Bleeding|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Absence of withdrawal bleeding was defined as no bleeding/spotting episode that began during or continued into the expected bleeding period. Expected bleeding period: NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle; LNG-EE: 7-day period starting on Day 22 of the cycle."|Every 28-day cycle for 6 cycles|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.
n=number of participants with evaluable cycles."||Participants|||Number
744932|NCT00511355|Secondary|Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding/spotting was defined as any episode that occurred during the expected non-bleeding period that was neither an early nor a continued withdrawal bleeding. Expected non-bleeding period: NOMAC-E2: 21-day period starting on Day 4 of the cycle; LNG-EE: 21-day period starting on Day 1 of the cycle."|Every 28-day cycle for 6 cycles|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.
n=number of participants with evaluable cycles."||Participants|||Number
744933|NCT00511355|Secondary|Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index)|In-treatment pregnancies were pregnancies with an estimated date of conception from the day of first intake of trial medication up to and including the day of last (active or placebo) intake of trial medication extended with a maximum of 2 days. Each 13 cycles (28 days per cycle) constitutes a woman year. The Pearl Index was obtained by dividing the number of in-treatment pregnancies that occurred by the time (in 100 women years) that the women were under risk of becoming pregnant.|6 cycles|"The restricted ITT set included all participants treated and excluded nonpregnant participants who didn't have >=1 cycle expected to be at risk for pregnancy (with recorded use of condoms or w/o sexual intercourse per diary card data)."||Pregnancies per 100 woman years|Woman years (rounded to nearest integer)|95% Confidence Interval|Number
744934|NCT00511355|Secondary|Serum Concentration of Dihydrotestosterone (DHT)|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||nmol/L||Standard Deviation|Mean
744935|NCT00511355|Secondary|Serum Concentration of Androstenedione|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||nmol/L||Standard Deviation|Mean
744936|NCT00511355|Primary|Serum Concentration of Thyroxin Binding Globulin (TBG)|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||mg/L||Standard Deviation|Mean
744937|NCT00511355|Primary|Serum Concentration of Free Thyroxine (T4)|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||pmol/L||Standard Deviation|Mean
744938|NCT00511355|Primary|Serum Concentration of Thyroid Stimulating Hormone (TSH)|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||mU/L||Standard Deviation|Mean
744942|NCT00511355|Primary|Incremental AUC3 for Insulin (OGTT)|Blood insulin levels were determined as fasting values just before oral glucose intake and each half hour thereafter for 2 hours and again after 3 hours. Oral glucose tolerance was analysed using the (unadjusted) area under the curve over the 3 hours (AUC3). Incremental area under the curve was defined as incremental AUC3 = AUC3 - 3*fasting concentration. Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||hrs*pmol/L||Standard Deviation|Mean
744943|NCT00511355|Primary|AUC3 for Insulin (OGTT)|Blood insulin levels were determined as fasting values just before oral glucose intake and each half hour thereafter for 2 hours and again after 3 hours. Oral glucose tolerance was analysed using the (unadjusted) area under the curve over the 3 hours (AUC3). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||hrs*pmol/L||Standard Deviation|Mean
744944|NCT00511355|Primary|Incremental AUC3 for Glucose (OGTT)|Blood glucose levels were determined as fasting values just before oral glucose intake and each half hour thereafter for 2 hours and again after 3 hours. Oral glucose tolerance was analysed using the (unadjusted) area under the curve over the 3 hours (AUC3). Incremental area under the curve was defined as incremental AUC3 = AUC3 - 3*fasting concentration. Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||hrs*mmol/L||Standard Deviation|Mean
744945|NCT00511355|Primary|Area Under the Curve Over 3 Hours (AUC3) for Glucose (Oral Glucose Tolerance Test [OGTT])|Blood glucose levels were determined as fasting values just before oral glucose intake and each half hour thereafter for 2 hours and again after 3 hours. Oral glucose tolerance was analysed using the (unadjusted) area under the curve over the 3 hours (AUC3). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||hrs*mmol/L||Standard Deviation|Mean
744946|NCT00511355|Primary|Serum Concentration of Total Triglycerides|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||mmol/L||Standard Deviation|Mean
744947|NCT00511355|Primary|Serum Concentration of Lipoprotein(a)|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||g/L||Standard Deviation|Mean
744948|NCT00511355|Primary|Serum Concentration of Apolipoprotein B|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||g/L||Standard Deviation|Mean
744949|NCT00511355|Primary|Serum Concentration of Apolipoprotein A-1|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||g/L||Standard Deviation|Mean
744950|NCT00511355|Primary|Serum Concentration of Low Density Lipoprotein (LDL)-Cholesterol|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||mmol/L||Standard Deviation|Mean
744951|NCT00511355|Primary|Serum Concentration of HDL3-cholesterol|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||mmol/L||Standard Deviation|Mean
744952|NCT00511355|Primary|Serum Concentration of HDL2-cholesterol|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||mmol/L||Standard Deviation|Mean
744953|NCT00511355|Primary|Serum Concentration of High Density Lipoprotein (HDL)-Cholesterol|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||mmol/L||Standard Deviation|Mean
744954|NCT00511355|Primary|Serum Concentration of Total Cholesterol|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||mmol/L||Standard Deviation|Mean
744955|NCT00511355|Primary|Serum Concentration of C-Reactive Protein (CRP)|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||mg/L||Standard Deviation|Mean
744992|NCT00511472|Secondary|Number of Participants Who Experienced an Adverse Event - Titration Scheme 1|In Titration Scheme #1, MK-0941/matching placebo was initiated at 10-mg q.a.c. dose and increased on a daily basis in 10-mg q.a.c. increments on Titration Dose [TD] Days 1 to 4 of the Titration Phase 1 of the study.|25 days|All participants who experienced one or more adverse events within 25 days of Titration Scheme 1||participants|||Number
744956|NCT00511355|Primary|Serum Concentration of Sex Hormone Binding Globulin (SHBG)|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||nmol/L||Standard Deviation|Mean
744957|NCT00511355|Primary|APC Resistance Ratio (Activated Partial Thromboplastin Time [APTT]-Based)|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). APC resistance ratio (APTT-based) measures the anticoagulation response of plasma to APC after activation of the intrinsic coagulation pathway. An increase in the ratio indicates a increased responsiveness to APC. Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||Ratio||Standard Deviation|Mean
744958|NCT00511355|Primary|Serum Concentration of Protein C|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||Percent of normal||Standard Deviation|Mean
744959|NCT00511355|Primary|Serum Concentration of Protein S (Total)|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||Percent of normal||Standard Deviation|Mean
744960|NCT00511355|Primary|Serum Concentration of Protein S (Free)|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||Percent of normal||Standard Deviation|Mean
744961|NCT00511355|Primary|Serum Concentration of Antithrombin III|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||Percent of normal||Standard Deviation|Mean
744962|NCT00511355|Primary|Serum Concentration of Clotting Factor II|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||Percent of normal||Standard Deviation|Mean
744963|NCT00511355|Primary|Serum Concentration of Clotting Factor VIII|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||Percent of normal||Standard Deviation|Mean
744964|NCT00511355|Secondary|Serum Concentration of Dehydroepiandrosterone Sulphate (DHEAS)|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||umol/L||Standard Deviation|Mean
744965|NCT00511355|Secondary|Serum Concentration of Free Testosterone|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||pmol/L||Standard Deviation|Mean
744966|NCT00511355|Secondary|Serum Concentration of Total Testosterone|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||nmol/L||Standard Deviation|Mean
744967|NCT00511355|Primary|Serum Concentration of Clotting Factor VIIc|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||Percent of normal||Standard Deviation|Mean
744968|NCT00511355|Primary|Serum Concentration of Clotting Factor VIIa|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||U/L||Standard Deviation|Mean
744969|NCT00511355|Primary|Activated Protein C (APC) Resistance Ratio (Endogenous Thrombin Potential [ETP]-Based)|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). APC resistance ratio (ETP-based) measures the anticoagulation response of plasma to APC after activation of the extrinsic coagulation pathway. An increase in the ratio indicates a reduced responsiveness to APC. Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||Ratio||Standard Deviation|Mean
744970|NCT00511355|Primary|Serum Concentration of D-Dimer|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||mg/L Fibrinogen Equivalent Units (FEU)||Standard Deviation|Mean
744971|NCT00511355|Primary|Serum Concentration of Prothrombin Fragments 1 + 2|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||nmol/L||Standard Deviation|Mean
744972|NCT00511433|Primary|Effect on Ovarian Function as Determined by Luteinizing Hormone (LH)|The parameter was measured at pre-defined study days.|Cycle 1, Cycle 2, Cycle 3, and Cycle 6|"ITT group consisted of all participants who were treated.
n=number of participants with non-missing values at the respective time point."||IU/L||Standard Deviation|Mean
744973|NCT00511433|Secondary|Average Number of Withdrawal Bleeding Days|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Withdrawal bleeding was defined as bleeding/spotting episode that started during or continued into the expected bleeding period. Expected bleeding period: DRSP-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle."|Every 28-day cycle for 6 cycles|"ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.
n= number of participants who had withdrawal bleeding/spotting for the respective cycle."||Days||Standard Deviation|Mean
744974|NCT00511433|Secondary|Average Number of Breakthrough Bleeding/Spotting Days|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding/spotting was defined as any episode that occurred during the expected non-bleeding period that was neither an early nor a continued withdrawal bleeding. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle."|Every 28-day cycle for 6 cycles|"ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.
n= number of participants who had breakthrough bleeding/spotting for the respective cycle."||Days||Standard Deviation|Mean
744975|NCT00511433|Primary|Effect on Ovarian Function as Determined by Follicle Stimulating Hormone (FSH)|The parameter was measured at pre-defined study days.|Cycle 1, Cycle 2, Cycle 3, and Cycle 6|"ITT group consisted of all participants who were treated.
n=number of participants with non-missing values at the respective time point."||International units per liter (IU/L)||Standard Deviation|Mean
744976|NCT00511433|Primary|Effect on Ovarian Function as Determined by 17 Beta-estradiol (E2)|The parameter was measured at pre-defined study days.|Cycle 1, Cycle 2, Cycle 3, and Cycle 6|"ITT group consisted of all participants who were treated.
n=number of participants with non-missing values at the respective time point."||picomoles per liter (pmol/L)||Standard Deviation|Mean
744977|NCT00511433|Primary|Effect on Ovarian Function as Determined by the Maximum Progesterone Value|The maximum progesterone value was defined as the largest value during a cycle.|Screening cycle, Cycle 1, Cycle 2, Cycle 3, and Cycle 6|"ITT group consisted of all participants who were treated.
n=number of participants completing the respective cycle with non-missing values."||nanomoles per liter (nmol/L)||Standard Deviation|Mean
744978|NCT00511433|Primary|Effect on Ovarian Function as Determined by the Maximum Follicle Diameter|The maximum follicular diameter was defined as the largest follicular diameter during a treatment cycle.|Screening cycle, Cycle 1, Cycle 2, Cycle 3, and Cycle 6|"ITT group consisted of all participants who were treated.
n=number of participants completing the respective cycle with non-missing values."||millimeters (mm)||Standard Deviation|Mean
744979|NCT00511433|Primary|Effect on Ovarian Function as Determined by the Number of Participants With an Occurrence of Ovulation|During treatment, ovulation was assessed for each participant by the investigator on the basis of ultrasound scanning (USS). The final analysis was based on assessor-blind adjudication.|Cycle 1, Cycle 2, and Cycle 6|"Intent-to-treat (ITT) group consisted of all participants who were treated.
n=number of participants completing the respective cycle with non-missing values."||Participants|||Number
744980|NCT00511433|Secondary|Number of Participants With an Occurrence of Continued Withdrawal Bleeding|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Continued withdrawal bleeding was defined as any withdrawal bleeding that continued into the expected non-bleeding period of the next cycle. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle."|Every 28-day cycle for 5 cycles|The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.||Participants|||Number
744981|NCT00511433|Secondary|Number of Participants With an Occurrence of Early Withdrawal Bleeding|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Early withdrawal bleeding was defined as any withdrawal bleeding that started before the current expected bleeding period. Expected bleeding period: DRSP-EE: 7-day period starting on Day 22 of the cycle; NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle."|Every 28-day cycle for 6 cycles|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.
n= number of participants with evaluable cycles."||Participants|||Number
744993|NCT00511472|Primary|Number of Participants Who Experienced an Adverse Event During the Study||39 days|All participants who experienced one or more adverse events during the study||participants|||Number
744994|NCT00511667|Primary|Participants Discontinued Because of Any Clinical Adverse Experience||Approximately 30 days after last dose of study drug (14 days for participants receiving MK0941 40 mg before each meal)|||participants|||Number
744982|NCT00511433|Secondary|Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only)|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough spotting was defined as any spotting episode that occurred during the expected non-bleeding period that was neither part of an early nor continued withdrawal bleeding. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2:21-day period starting on Day 4 of the cycle."|Every 28-day cycle for 6 cycles|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.
n=number of participants with evaluable cycles."||Participants|||Number
744983|NCT00511433|Secondary|Number of Participants With an Occurrence of Breakthrough Bleeding|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding was defined as any bleeding episode that occurred during the expected non-bleeding period that was neither part of an early nor continued withdrawal bleeding. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2:21-day period starting on Day 4 of the cycle."|Every 28-day cycle for 6 cycles|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.
n=number of participants with evaluable cycles."||Participants|||Number
744984|NCT00511433|Secondary|Number of Participants With an Occurrence of Absence of Withdrawal Bleeding|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Absence of withdrawal bleeding was defined as no bleeding/spotting episode that began during or continued into the expected bleeding period. Expected bleeding period: DRSP-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle."|Every 28-day cycle for 6 cycles|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.
n=number of participants with evaluable cycles."||Participants|||Number
744985|NCT00511433|Secondary|Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding/spotting was defined as any episode that occurred during the expected non-bleeding period that was neither an early nor a continued withdrawal bleeding. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle."|Every 28-day cycle for 6 cycles|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.
n=number of participants with evaluable cycles."||Participants|||Number
744986|NCT00511433|Secondary|Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index)|In-treatment pregnancies were pregnancies with an estimated date of conception from the day of first intake of trial medication up to and including the day of last (active or placebo) intake of trial medication extended with a maximum of two days. Each 13 cycles (28 days per cycle) of exposure constitutes a woman year. The Pearl Index was obtained by dividing the number of in-treatment pregnancies that occurred by the time (in 100 woman years) that the women were under risk of becoming pregnant.|6 cycles|"The restricted ITT set included all participants treated and excluded nonpregnant participants who didn't have >=1 cycle expected to be at risk for pregnancy (with recorded use of condoms or without sexual intercourse per diary card data)."||Pregnancies per 100 woman years|Participants|95% Confidence Interval|Number
744987|NCT00511433|Secondary|Effect on Maximum Endometrial Thickness|Maximum endometrial thickness was defined as the largest endometrial thickness during a cycle.|Screening Cycle, Cycle 1, Cycle 2, and Cycle 6|"ITT group consisted of all participants who were treated.
n=number of participants completing the respective cycle."||mm||Standard Deviation|Mean
744988|NCT00511433|Secondary|Effect on Cervical Mucus as Determined by Insler Score|The Insler Score was assessed on Day 6 after ovulation during the Screening Cycle, on Day 21 of Cycle 1, and when the maximum follicle diameter was greater than or equal to 15 mm. The Insler Score consisted of four categories each scaled from 0 (none) to 3 (complete). The higher the score, the greater the cervical reaction.|Screening Cycle, Cycle 1, Cycle 2, and Cycle 7 (post-treatment cycle)|"ITT group consisted of all participants who were treated.
n=number of participants with non-missing values at the respective time point."||score on a scale||Standard Deviation|Mean
744989|NCT00511472|Secondary|Number of Participants Who Experienced an Adverse Event During the Outpatient Treatment Period|During the Outpatient Treatment Period, participants were followed for an additional 2 weeks while at home.|Outpatient Days 1 to 14|All participants who experienced one or more adverse events during the Outpatient Treatment Period.||participants|||Number
744990|NCT00511472|Secondary|24-Hour Weighted Mean Blood Glucose Levels (mg/dL) by Treatment Group on Day 7|Measurement of the 24-hour weighted mean blood glucose levels of participants receiving MK-0941 or placebo while on basal insulin on Day 7.|24 hours|All participants who had 24-hour weighted mean blood glucose levels evaluated on Day 7||mg/dL||Standard Deviation|Least Squares Mean
744991|NCT00511472|Secondary|Number of Participants Who Experienced an Adverse Event - Titration Scheme 2|Titration Scheme #2 (Titration Phase, Days 1 to 4) was a flexible-dose titration scheme in which MK-0941/matching placebo was given at a dose determined by a pre-prandial plasma glucose concentration for the subsequent meal on the previous day of administration.|25 days|All participants who experienced one or more adverse events within 25 days of Titration Scheme 2||participants|||Number
745001|NCT00511706|Secondary|Change From Screening in the Area of Leakage From Choroidal Neovascularization (CNV) at Week 25 as Assessed by Fluorescein Angiography in the Study Eye|Fluorescein angiography (FA) is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. Photographs are taken with a specialized low-power microscope with an attached camera designed to photograph the interior of the eye, including the retina and optic disc. FA was performed on the study eye after dilation at Screening and Week 25.|Screening (-Week 28), Week 25|Participants from the intent-to-treat population (all randomized participants) with data available at Screening and Week 25 for analyses.||Millimeters square (MM^2)||Standard Deviation|Mean
745002|NCT00511706|Secondary|Change From Baseline in the Mean Central Retinal Subfield Thickness at Week 25 as Assessed by Optical Coherence Tomography (OCT) in the Study Eye|Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed in the study eye after pupil dilation at baseline and Month 25.|Baseline, Week 25|Participants from the Intent-to-treat population (all randomized patients) with data available at Baseline and Week 25 for analyses.||Microns||Standard Deviation|Mean
745003|NCT00511706|Secondary|Change From Baseline in the Best Corrected Visual Acuity (BCVA) at Week 25|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|Baseline, Week 25|Participants from the Intent-to-treat population (all randomized patients) with data available at Baseline and Week 25 for analyses.||Letters||Standard Deviation|Mean
745004|NCT00511706|Primary|Injection Free Interval|The injection free interval was defined as the number of days between receiving the second ranibizumab injection (day 7 to 14) to the investigator’s determination of eligibility to receive a third ranibizumab injection in the study eye.|Week 1 to Week 25|Intent-to-treat population consisted of all randomized patients.||Days||Inter-Quartile Range|Median
745005|NCT00511797|Post-Hoc|Change From Baseline in Total Dysmenorrheal Score at Final Evaluation in Patients Without Previous Medication|Total dysmenorrheal score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Total possible best is 0, and total possible worst is 6. Note: used with permission of Nobelpharma Co., Ltd. from the phase 3 clinical study protocol (Prog Med 2005:25 (3):739-758) of IKH-01 in dysmenorrhea (associated with endometriosis) (Nobelpharma Co., Ltd.)|Baseline and up to 4 Cycles (28 days per cycle)|The number of subjects without previous medication in DRSP 1 mg/EE 20 μg group was 1, so the standard deviation was not measurable. The number of subjects without previous medication in the other three groups were 0, so the data were not applicable.||scores on a scale||Standard Deviation|Mean
745006|NCT00511797|Post-Hoc|Change From Baseline in Total Dysmenorrheal Score at Final Evaluation in Subgroups (2)|Total dysmenorrheal score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Total possible best is 0, and total possible worst is 6. Note: used with permission of Nobelpharma Co., Ltd. from the phase 3 clinical study protocol (Prog Med 2005:25 (3):739-758) of IKH-01 in dysmenorrhea (associated with endometriosis) (Nobelpharma Co., Ltd.)|Baseline and up to 4 Cycles (28 days per cycle)|FAS||scores on a scale||Standard Deviation|Mean
745007|NCT00511797|Post-Hoc|Change From Baseline in Total Dysmenorrheal Score at Final Evaluation in Subgroups (1)|Total dysmenorrheal score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Total possible best is 0, and total possible worst is 6. Note: used with permission of Nobelpharma Co., Ltd. from the phase 3 clinical study protocol (Prog Med 2005:25 (3):739-758) of IKH-01 in dysmenorrhea (associated with endometriosis) (Nobelpharma Co., Ltd.)|Baseline and up to Cycle 4 (28 days per cycle)|FAS||scores on a scale||Standard Deviation|Mean
745008|NCT00511797|Post-Hoc|Change From Baseline for Total Pelvic Pain Score at Times Other Than During Menstruation at Cycle 4|Total pelvic pain score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Total possible best is 0, and total possible worst is 6.|From baseline to Cycle 4(28 days per cycle)|FAS (Participants with data at Cycle 4)||scores on a scale||Standard Deviation|Mean
745009|NCT00511797|Secondary|Change From Baseline in Serum Progesterone Level at Cycle 4|Progesterone is a steroid hormone involving in the female menstrual cycle, pregnancy, etc.|From baseline to Cycle 4 (28 days per cycle)|FAS (Participants with data at Cycle 4)||ng/mL||Full Range|Mean
745010|NCT00511797|Secondary|Change From Baseline in Serum Estradiol Level After 4-cycle Treatment|Estradiol is a predominant sex hormone that presents in female.|From baseline to Cycle 4 (28 days per cycle)|FAS (Participants with data at Cycle 4)||pg/mL||Full Range|Mean
745011|NCT00511797|Secondary|Change From Baseline in Serum C-reactive Protein (CRP) After 4-cycle Treatment|CRP is a laboratory parameter giving an indication of inflammation, whose elevated levels that were defined by a lab suggest a potential inflammation.|From baseline to Cycle 4 (28 days per cycle)|FAS (Participants with data at Cycle 4)||mg/dL||Full Range|Mean
745012|NCT00511797|Secondary|Change From Baseline in Serum Carbohydrate Antigen-125 (CA125) After 4-cycle Treatment|CA125 is a laboratory parameter giving an indication of having tumor, whose elevated levels that were defined by a lab suggest a potential tumor.|From baseline to Cycle 4 (28 days per cycle)|FAS (Participants with data at Cycle 4)||Units/L||Full Range|Mean
745013|NCT00511797|Secondary|Participants With Non-heavy Withdrawal Bleeding|Non-heavy bleedings were defined as those other than heavy bleeding (less or normal bleeding).|At Cycle 4 (28 dyas per cycle)|FAS (Participants with data at Cycle 4)||participants|||Number
745014|NCT00511797|Secondary|Participants With Non-heavy Intracyclic Bleeding|Non-heavy bleedings were defined as those other than heavy bleeding (less or normal bleeding).|At Cycle 4 (28 days per cycle)|FAS (Participants with data at Cycle 4)||participants|||Number
745015|NCT00511797|Secondary|Participants With Intracyclic Bleeding|Intracyclic bleedings were defined as bleedings while a participant takes active drugs.|At Cycle 4 (28 days per cycle)|FAS (Participants with data at Cycle 4)||participants|||Number
745016|NCT00511797|Secondary|Participants With Withdrawal Bleeding|Withdrawal bleedings were defined as bleedings while a participant takes placebo tablets.|At Cycle 4 (28 days per cycle)|FAS (Participants with data at Cycle 4)||participants|||Number
745018|NCT00511797|Secondary|Number of Bleeding / Spotting Episodes|Bleeding data were captured from the diary a participant recorded by herself. Bleeding is a genital bleeding. Spotting is a slight genital bleeding with participant's experience. An episode means a series of bleeding and/or spotting. The bleeding /spotting analyses are by intensity.|For the first 90 days|FAS (Participants with the defined data)||number of episodes||Standard Deviation|Mean
745019|NCT00511797|Secondary|Change From Baseline in Endometrial Thickness After 4-cycle Treatment|Endometrial thickness was measured via transvaginal ultrasound examination. The endometrium is the inner membrane of the uterus. During the menstrual cycle, the endometrium grows to a thick, blood vessel-rich, glandular tissue layer.|From baseline to Cycle 4 (28 days per cycle)|FAS (Participants with data at Cycle 4)||mm||Standard Deviation|Mean
745020|NCT00511797|Secondary|Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation at Cycle 4|VAS is an unmarked scale on a line 100 mm in length, indicating from 0 mm (no pain) to 100 mm (worst pain a participant has ever experienced).|Cycle 4 (28 days per cycle)|FAS (Participants with data at Cycle 4)||scores on a scale||Standard Deviation|Mean
745021|NCT00511797|Secondary|Change From Baseline in Visual Analogue Scale (VAS) for Dysmenorrhea at Times Other Than During Menstruation at Cycle 4|VAS is an unmarked scale on a line 100 mm in length, indicating from 0 mm (no pain) to 100 mm (worst pain a participant has ever experienced).|From baseline up to Cycle 4 (28 days per cycle)|FAS (Participants with data at Cycle 4)||scores on a scale||Standard Deviation|Mean
745022|NCT00511797|Secondary|Number of Participants With Total Pelvic Pain Score at Times Other Than During Menstruation at Cycle 4|Total pelvic pain score was defined as sum of 2 sub-scores: severity of dysmenorrhea and use of analgesics. Higher score means it is more severe. 0=None, 6=Severest.|Cycle 4 (28 days per cycle)|FAS (Participants with data at Cycle 4)||participants|||Number
745023|NCT00511797|Secondary|Number of Participants With Severity of Nausea or Vomiting During Menstruation at Cycle 4|Severity of nausea or vomiting during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).|Cycle 4 (28 days per cycle)|FAS (Participants with data at Cycle 4)||participants|||Number
745024|NCT00511797|Secondary|Number of Participants With Severity of Headache During Menstruation at Cycle 4|Severity of headache during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).|Cycle 4 (28 days per cycle)|FAS (Participants with data at Cycle 4)||participants|||Number
745025|NCT00511797|Secondary|Number of Participants With Severity of Low Back Pain During Menstruation at Cycle 4|Severity of low back pain during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).|Cycle 4 (28 days per cycle)|FAS (Participants with data at Cycle 4)||participants|||Number
745026|NCT00511797|Secondary|Number of Participants With Severity of Lower Abdominal Pain During Menstruation at Cycle 4|Severity of lower abdominal pain during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).|Cycle 4 (28 days per cycle)|FAS (Participants with data at Cycle 4)||participants|||Number
745027|NCT00511797|Secondary|Change From Baseline in Total Dysmenorrheal Score at Cycle 1 up to Cycle 4|Total dysmenorrheal score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Total possible best is 0, and total possible worst is 6.|Baseline and up to 4 Cycles (28 days per cycle)|FAS||scores on a scale||Standard Deviation|Mean
745028|NCT00511797|Primary|Change From Baseline in Total Dysmenorrheal Score at Final Evaluation|Total dysmenorrheal score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Total possible best is 0, and total possible worst is 6. Note: used with permission of Nobelpharma Co., Ltd. from the phase 3 clinical study protocol (Prog Med 2005:25 (3):739-758) of IKH-01 in dysmenorrhea (associated with endometriosis) (Nobelpharma Co., Ltd.)|Baseline and up to 4 Cycles (28 days per cycle)|FAS||scores on a scale||Standard Deviation|Mean
745029|NCT00511810|Primary|Mood Symptoms Ratings|Depression symptom severity was determined with the Children’s Depression Rating Scale-Revised (CDRS-R), which is a brief rating scale based on a semi-structured interview with the child. It is a 17-item observer-rated questionnaire where the 17 symptom areas are rated on a 6- or 7-point scale. Total score ranges from a low (not depressed) of 17 to a maximum (very depressed) of 108. Remission was defined as a CDRS-R score of <28. (The total score is the sum of the ratings on each of the 17 items.)|10 weeks|||CDRS-R score||Standard Deviation|Mean
745030|NCT00511836|Primary|Change From Baseline in BOLD Signal Activation Values in the Reward Circuitry||14 days (Baseline to Day 14)|Analyses include all randomized, dosed subjects who had functional magnetic resolution imaging (fMRI) on Day 14. No data were imputed.||Percentage (%) of Change||Standard Deviation|Mean
745031|NCT00511836|Primary|Change From Baseline in BOLD Signal Activation Values for the Inferior Frontal Gyrus||14 days (Baseline to Day 14)|Analyses include all randomized, dosed subjects who had functional magnetic resolution imaging (fMRI) on Day 14. No data were imputed.||Percentage (%) of Change||Standard Deviation|Mean
745032|NCT00511836|Secondary|Change From Baseline in Daily Craving Score in Alcohol-dependent Subjects (Actiwatch Data)|The Actiwatch-Score device (MiniMitter Co.) was used to collect data on daily alcohol craving. The Actiwatch device is a wrist-worn, battery-operated monitor programmed to beep every 3 hours ±20 minutes, to signal the subjects to enter their alcohol craving or desire to use alcohol at that exact moment on a scale of 0 to 10 units: 0 indicates no craving at all (best score) and 10 indicates extreme craving (worst score). A negative result for Change in Baseline at Day 28 indicates an improvement in daily craving as of 1 month after study drug administration.|28 days (Baseline to Day 28)|All randomized subjects who received at least 1 dose of study drug and had a craving score assessment at Day 28 were included in this analysis. No last-observation-carried-forward (LOCF) approach was used.||Change in Daily Craving Score||Standard Deviation|Mean
745101|NCT00512798|Secondary|Patients With Inhibition in NF-kB Activation (Phase I)|Patient with a minimum of 50% reduction from baseline on day 8 or day 29 in NF-kB, measured by picograms/milliliter in peripheral mononuclear blood cells|at baseline, on day 8 and on day 29|Phase I patients for whom blood was taken at baseline,on day 8 and on day 29 of each cycle. There was no correlation of change in NF-kB activation with changes in tumor tissue||participants|||Number
745033|NCT00511836|Secondary|Change From Baseline in Obsessive-Compulsive Drinking Scale (OCDS) Score in Alcohol-dependent Subjects|There are 14 items on the Obsessive Compulsive Drinking Scale (OCDS). The scale is scored from 0 to 40 (units). A score of 0 units indicates no obsession-compulsion with respect to alcohol (best score). A score of 40 units indicates maximum obsession-compulsion with respect to alcohol (worst score). A negative Change from Baseline value indicates an improvement. For scoring methods, see: Anton RF, Moak DH, Latham P (1995), The Obsessive Compulsive Drinking Scale: A self-rated instrument for the quantification of thoughts about alcohol and drinking behavior. Alcohol Clin Exp Res 19:92-9.|28 days (Baseline to Day 28)|All randomized subjects who received at least 1 dose of study drug and had an Obsessive-Compulsive Drinking Scale (OCDS) assessment at Day 28 were included in this analysis. No last-observation-carried-forward (LOCF) approach was used.||Change in OCDS score||Standard Deviation|Mean
745034|NCT00511836|Primary|Change From Baseline in Blood Oxygen-level-dependent (BOLD) Signal Activation Values Detected in the Reward Circuitry of the Brain in Alcohol-dependent Subjects After Presentation of Alcohol-related Cues.|As was standard among fMRI studies conducted at the study site at the time, a change in BOLD signal in the range of 5% to 6% in anterior cingulate as measured using a 3T magnet,is considered highly significant in block-designed experiments.|14 days (Baseline to Day 14)|Analyses include all randomized, dosed subjects who had functional magnetic resolution imaging (fMRI) on Day 14. No data were imputed.||Percentage (%) of Change||Standard Deviation|Mean
745035|NCT00511862|Post-Hoc|2 Year Survival|The percentage of patients in the neuroendocrine group alive at 2 years|24 months from treatment|||percentage of treated subjects|||Number
745036|NCT00511862|Secondary|Overall Survival|Duration of survival from date of first TheraSphere treatment to date of death or censored to last known date alive.|Time from first TheraSphere treatment to death; median follow up 30 months|In the neuroendocrine group, a median overall survival was not achieved so a post-hoc analysis of 2 year survival was performed in Outcome Measure 3.||Months||95% Confidence Interval|Median
745037|NCT00511862|Primary|Hepatic Progression-free Survival According to Response Evaluation Criterian in Solid Tumors (RECIST)|Progression per RECIST v 1.0 is defined as at least 20% increase in the sum of the longest diameter of target lesions, taking as the reference the smallest sum of longest diameters recorded since treatment started, or unequivocal progression of existing non-target lesion or appearance of new lesions. A maximum of 5 target lesions per organ are assessed. To assess the impact of a non-systemic local therapy on progression, for the purposes of this trial, hepatic progression was defined as at least a 20% increase in the sum of the longest diameter of target hepatic lesions. Hepatic progression-free survival is the time from the day of first treatment with TheraSphere to determination of hepatic progression.|From the date of first treatment until date of first documented progression; median patient follow-up 30 months|Patients receiving at least one TheraSphere treatment with images evaluable by RECIST||Months||95% Confidence Interval|Median
745038|NCT00511901|Secondary|POMS Depression-Dejection Scale|Profile of Mood States (POMS) Depression-Dejection Scale 15 item questionnaire to measure the degree of depressive thoughts. The scale ranges from 0 to 60 (most depressed).|3,8,12 weeks|exact numbers of subjects analyzed at each time point vary based on time of study withdrawal for those who withdrew and availability of subject for those who were under active follow-up||Scores on a Scale||Inter-Quartile Range|Median
745039|NCT00511901|Secondary|Activity Counts|Activity counts as measured by the Actigraph monitor. Higher counts indicate more activity.|3, 8, and 12 weeks following randomization|exact numbers of subjects analyzed at each time point vary based on time of study withdrawal for those who withdrew and availability of subject for those who were under active follow-up||Counts||Standard Deviation|Mean
745040|NCT00511901|Secondary|FACIT Measurement System Fatigue Scale|Fatigue score ranges from 0 to 72. Lower score represents less fatigue|3, 8, and 12 weeks following randomization|exact numbers of subjects analyzed at each time point vary based on time of study withdrawal for those who withdrew and availability of subject for those who were under active follow-up||Scores on a Scale||Standard Deviation|Mean
745041|NCT00511901|Secondary|Short Physical Performance Battery (SPPB) Score|Measure physical function scored 0 - 12 (better)|3, 8, and 12 weeks following randomization|exact numbers of subjects analyzed at each time point vary based on time of study withdrawal for those who withdrew and availability of subject for those who were under active follow-up||Scores on a scale||Standard Deviation|Mean
745042|NCT00511901|Secondary|Grip Strength|kilograms measured by hand held dynamometer|3, 8, and 12 weeks following randomization|exact numbers of subjects analyzed at each time point vary based on time of study withdrawal for those who withdrew and availability of subject for those who were under active follow-up||kg||Standard Deviation|Mean
745043|NCT00511901|Secondary|Length of Stay in Subacute Rehabilitation Facility|Days from randomization to discharge|12 weeks following randomization|exact numbers of subjects analyzed at each time point vary based on time of study withdrawal for those who withdrew and availability of subject for those who were under active follow-up||Days||Standard Deviation|Mean
745044|NCT00511901|Secondary|Motor-FIM Score|FIM Motor score ranges from 13 to 91 (most independent)|3, 8, and 12 weeks following randomization|exact numbers of subjects analyzed at each time point vary based on time of study withdrawal for those who withdrew and availability of subject for those who were under active follow-up||Scores on a Scale||Standard Deviation|Mean
745045|NCT00511901|Primary|Mean Hemoglobin Concentration at 8 Weeks After Entry Into the Study||8 weeks following randomization|Intention to treat; of the subjects not lost to follow-up, 3 subjects in the placebo arm & 2 subjects in the epoetin alpha arm were not available for 8 week hemoglobin draw||g/dL||Standard Deviation|Mean
745046|NCT00511914|Primary|Percentages of Subjects With Seroconversion or Significant Increase After 1 Dose of Cell Culture Derived Vaccine (cTIV).|"Proportion of subjects with either seroconversion (antibody increase from < 10 pre vaccination to ≥40 post vaccination) or significant increase (antibody titer of ≥10 pre vaccination and 4-fold antibody increase post vaccination).
According to the CHMP criteria, the percentages of subjects achieving seroconversion or significant increase should be >40% for adults and >30% for elderly subjects."|3 weeks postvaccination (Day 22)|Analysis was done on per protocol set||Percentages of Subjects||95% Confidence Interval|Number
745102|NCT00512798|Primary|Optimal Doses of Temozolomide and Bortezomib (Phase I)|The optimal biologic dose (OBD) defined as the dose that achieves the greatest degree of inhibition of NF-κB activation in peripheral blood mononuclear cells when co-administered with Temozolomide|up to 42 days|All Phase I patients who received the study drugs||mg/m2|||Number
745047|NCT00511914|Primary|Percentages of Subjects With HI Titer ≥40 After 1 Dose of Cell Culture Derived Vaccine (cTIV).|"HI titer as assessed by hemagglutination inhibition (HI) assay using egg derived antigen in adults and elderly subjects.
This criterion is met according to European (CHMP) guideline if the percentages of subjects achieving HI titers ≥40 is >70% for adults and >60% for elderly subjects."|3 weeks postvaccination (Day 22)|Analysis was done on per protocol set||Percentages of Subjects||95% Confidence Interval|Number
745048|NCT00511914|Primary|Geometric Mean Ratio After 1 Dose of the Cell Culture Derived Vaccine (cTIV)|"Geometric mean ratio (GMR) of Day 22 / Day 1 geometric mean antibody titers was assessed by hemagglutination inhibition (HI)assay using egg derived antigen in adults and elderly subjects.
The criterion is met according to European (CHMP) guideline if the mean geometric increase GMR (Day22 / Day1) in HI antibody titer is >2.5 for adults and >2.0 for elderly subjects."|3 weeks postvaccination (Day 22)|Analysis was done on per protocol set||Ratio||95% Confidence Interval|Geometric Mean
745049|NCT00511914|Secondary|Number of Subjects Reporting Local and Systemic Reactions|To evaluate the safety and tolerability of cell culture derived vaccine (cTIV) in adults and elderly subjects in terms of number of subjects reporting local and systemic reactions after 1 vaccine dose.|3 days postvaccination|Analysis was done on safety set.||Subjects|||Number
745050|NCT00511914|Primary|Geometric Mean Titers (GMT) After 1 Dose of Cell Culture Derived Vaccine (cTIV).|Pre and postvaccination geometric mean titers against all 3 strains were assessed by hemagglutination inhibition (HI) assay using egg derived antigen in adults and elderly subjects.|3 weeks postvaccination (Day 22)|Analysis was done on per protocol set||Titer||95% Confidence Interval|Geometric Mean
745051|NCT00511992|Secondary|Number of Patients Who Experienced Toxicities Associated With Intraperitoneal Cisplatin With Intravenous Paclitaxel and Avastin.|CTCAE assessment of toxicity|2 years|||Participants|||Count of Participants
745052|NCT00511992|Primary|Number of Patients Able to Complete 6 Cycles of Treatment.|Completion of cycle 6|2 years|||Participants|||Count of Participants
745053|NCT00512096|Primary|Number of Participants With Pathologic Complete Remission (pCR)|Histopathologic assessment of surgical resection to confirm Pathologoic Complete Remission. Complete remission defined as disappearance of all target lesions.|restaging with second and fourth 21-day cycles followed by surgery|Participants who completed chemotherapy without progression then had surgical resection.||participants|||Number
745054|NCT00512148|Primary|Overall Safety Profile - Number of Participants Experiencing an Adverse Event|Clinical evaluation of adverse events, laboratory parameters and urinary imaging to assess any safety issues emerging from this technology and to allow a comparison of a safety profile with standard of care enterocystoplasty. Please refer to adverse event section for detailed information.|through month 12|This analysis was performed on the safety population. Patients undergoing screening and meeting inclusion/exclusion criteria were included in the safety population||participants|||Number
745055|NCT00512148|Primary|Change in Maximum Detrusor Pressure From Baseline to 12 Months|Detrusor pressure is measured using urodynamic testing, which involves inserting a catheter through the urethra and into the bladder and measuring the pressure in the bladder as it is filled with fluid. The primary outcome measure for this study was the change in the maximum pressure observed during bladder filling from baseline to 12 months. The goal of the therapy was to decrease pressure.|baseline and 12 months|All patients with urodynamics measurement performed at baseline and month 12 were included in the analysis.||centimeters of water (cm H2O)||95% Confidence Interval|Mean
745056|NCT00512148|Secondary|Urodynamic Measurements and Long Term Safety||month 12 through month 60||||||
745057|NCT00512252|Secondary|Relapse-free Survival|"This is determined only for patients achieving a complete remission. Defined as the interval from the date of the first documentation of a leukemia free state to date of recurrence or death due to any cause.
Kaplain-Meier estimate was used."|1 year|This excludes the 25 participants who had treatment failure.||percentage of participants|||Number
745058|NCT00512252|Secondary|Overall Survival||1 year|||percentage of participants|||Number
745059|NCT00512252|Secondary|Treatment Failure|Treatment failures includes those patients for whom treatment has failed to achieve a CR or a CRi.|42 days|||participants|||Number
745060|NCT00512252|Secondary|Time to Progression||Every 6 months|"This outcome was not analyzed instead reason for treatment failure was analyzed as it provided better information on why the treatment did not work."|||||
745061|NCT00512252|Secondary|Pharmacokinetics of AMD3100 on MEC||Day 1 - Phase 2 only|This was not performed.|||||
745062|NCT00512252|Secondary|Characterize the Mobilization of Leukemic Cells With AMD3100 by Measuring the Peak Mobilization of AML Blasts (Phase I)|Measured at 0 hours, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, and 24 hours after AMD3100 dose on Day 0.|Day 0|||percentage of AML blasts||Full Range|Median
745063|NCT00512252|Secondary|Characterize the Mobilization of Leukemic Cells With AMD3100 by Measuring the Peak Mobilization of Total Leukocytes (Phase I)|"Measured at 0 hours, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, and 24 hours after AMD3100 dose on Day 0.
Characterization of the mobilized cells as well as the kinetics of mobilization will be determined by analyzing the surface expression of mobilized cells by flow cytometry at the specified time points in conjunction with their total leukocyte count from the patient's CBC."|Day 0|||cells x 10^3/microliter||Full Range|Median
745064|NCT00512252|Secondary|Time to Platelet Recovery|Defined as the date of the first dose of AMD3100 to the date that the platelet count is >100,000/mm3 in the absence of platelet transfusions.|42 days|This analysis includes patients who achieved a CR.||days||Full Range|Median
745065|NCT00512252|Secondary|Time to Neutrophil Recovery|Defined as the date of the first dose of AMD3100 to the date that the absolute neutrophil count >1,000 cells/mm^3.|42 days|This analysis includes patients who achieved a CR or a CRi.||days||Full Range|Median
745066|NCT00512252|Secondary|Safety and Tolerability of AMD3100 + MEC.|Treatment related mortality (deaths occurring during treatment)|42 days|The 46 patients include the 6 patients treated on Dose Level 3 of the Phase I portion of the study.||participants|||Number
745067|NCT00512252|Primary|Ability of AMD3100 + MEC to Induce dsDNA Damage and Apoptosis in Leukemic Blasts From Bone Marrow or Peripheral Blood Fractions||42 days|This outcome was not analyzed as data was not collected.|||||
745103|NCT00512876|Secondary|Size and Extent of Corneal Neovascularization|computerized image analysis of the corneal photographs were used to measure the change in size and extent of corneal neovascularization from baseline.|24 weeks|||percentage change||Standard Deviation|Mean
745104|NCT00512876|Primary|Adverse Events (Ocular and Systemic)||24 weeks|||participants|||Number
745069|NCT00512252|Primary|Phase I Only: Optimal Dose of AMD3100 Plus MEC in Patients With Relapsed or Refractory AML|A standard 3+3 design was used in the Phase I portion starting with the AMD3100 dose of 80 mcg/kg and escalating by 80 mcg/kg for each successive cohort up to a maximum of 240 mcg/kg/d. The optimal dose was defined as the highest dose of AMD3100 <= 240 mcg/kg at which 0-1 of 6 patients experienced a dose limiting toxicity.|Completion of all patients in Phase I portion (232 days)|The Phase I Dose Escalation portion included (3) patients enrolled in Dose Level 1 and (3) patients enrolled in Dose Level 2. The (6) patients enrolled in Dose Level 3 that determined the Phase II dose are included in the population for this outcome.||mcg/kg|||Number
745070|NCT00512278|Secondary|Percentage of Participants Experiencing Medically Significant Infections|Medically significant infection was defined as an infection requiring the use of intravenous antibiotics or hospitalization.|72 weeks from initiation of treatment|||Participants|||Count of Participants
745071|NCT00512278|Secondary|Percentage of Participants Experiencing Serious Adverse Events|The severity of adverse events was graded according to modified World Health Organization grades as mild, moderate, severe, or life-threatening|72 Weeks from initiation of treatment|||Participants|||Count of Participants
745072|NCT00512278|Primary|Number of Participants Achieving Sustained Virological Response (SVR)|HCV RNA negativity at 24 weeks after completion of all study medications|24 weeks after completion of all study medications|||Participants|||Count of Participants
745073|NCT00512278|Secondary|A Comparison of the Percentage of Participants With Non-detectable HCV-RNA After 24 Weeks of Therapy.|A comparison of the proportion of the subject population with non-detectable HCV-RNA after 24 wks of therapy.|24 weeks|||Participants|||Count of Participants
745074|NCT00512278|Primary|A Comparison of the Percentage of Chronic Hepatitis C Subjects (Treatment Naive,Genotype 1) Who Achieve SVR at Week 72, After 48 Weeks of Treatment.|A comparison of the Proportion of Chronic Hepatitis C Subjects (Treatment Naive,Genotype 1) Who Achieve SVR at Week 72, After 48 Weeks of TreatmentSVR in both study arms|72 Weeks from initiation of treatment|Included all patients who received at least one dose of treatment in both study arms||percentage of participants|||Number
745075|NCT00512707|Other Pre-specified|Change From Baseline in Sex Hormone Binding Globulin (SHBG)||Week 0, Week 14|All available data expressed as absolute value at the given time-point.||nmol/L||Standard Deviation|Mean
745076|NCT00512707|Other Pre-specified|Change From Baseline in Free Testosterone|Free testosterone levels were calculated from total testosterone at screening and equilibrium dialysis at randomization and at trial end.|Week 0, Week 14|All available data expressed as absolute value at the given time-point.||pg/mL||Standard Deviation|Mean
745077|NCT00512707|Other Pre-specified|Change From Baseline in Total Testosterone|Total testosterone levels were measured between 7:30 and 10:10 a.m. using a liquid chromatography-tandem mass spectrometry assay certified by the Centers for Disease Control and Prevention's Hormone Standardization Program.|Week 0, Week 14|All available data expressed as absolute value at the given time-point.||ng/dL||Standard Deviation|Mean
745078|NCT00512707|Secondary|Change From Baseline in Positive Affects Ratio (PAR) of Derogatis Affects Balance Scale (DABS)|The Derogatis Affects Balance Scale (DABS) is a 40-item mood inventory and consists of 4 positive affect dimensions (joy, contentment, vigor, and affection) as well as 4 negative affect dimensions(anxiety, depression, guilt, and hostility). Positive Affects Ratio (PAR), ranging from 0 to 1, is the proportion of total scores (sum of all 8 domains) that is positive (sum of 4 positive domains). Higher PAR represents better affectivity.|Week 0, Week 8, Week 14|All available data expressed as absolute value at the given time-point.||ratios||Standard Deviation|Mean
745079|NCT00512707|Secondary|Change From Baseline in Derogatis Affects Balance Scale (DABS)|The Derogatis Affects Balance Scale (DABS) is a 40-item mood inventory and consists of 4 positive affect dimensions (joy, contentment, vigor, and affection) as well as 4 negative affect dimensions(anxiety, depression, guilt, and hostility). Each domain was calculated as the sum of 5-items and could range from 0 to 20, wherein higher scores indicate greater affectivity.|Week 0, Week 8, Week 14|All available data expressed as absolute value at the given time-point.||units on a scale||Standard Deviation|Mean
745080|NCT00512707|Secondary|Change From Baseline in Psychological General Well-Being Index Score (PGWBI)|Well-being and mood were assessed using the Psychological General Well-Being Index (PGWBI), a 22-item questionnaire that evaluated six dimensions of self-reported wellness: Anxiety (5 questions), Depressed Mood (3 questions), Positive Well-Being (4 questions), Self Control (3 questions), General Health (3 questions), and Vitality (4 questions). Higher scores in each dimension reflect increasing well-being. A global score (ranging from 0 (poor QoL) to 110 (good QoL)) was calculated as the sum of each domain score. The global score and those of its 6 dimensions were normalized to a 100% scale to facilitate comparison.|Week 0, Week 8, Week 14|All available data expressed as absolute value at the given time-point.||units on a scale||Standard Deviation|Mean
745081|NCT00512707|Secondary|Change From Baseline in Marital Interaction Scale of CAncer Rehabilitation Evaluation System-Short Form (CARES-SF)|CAncer Rehabilitation Evaluation System-short form (CARES-SF) marital interaction scale consists of 6 items (range from 0 (best) to 4) and mean of these 6 questions was used to determine intimacy and partner interaction. Lower CARES-SF scores correspond with improved marital interaction.|Week 0, Week 8, Week 14|All available data expressed as absolute value at the given time-point.||units on a scale||Standard Deviation|Mean
745082|NCT00512707|Secondary|Change From Baseline in Quality of Life Specific to Male Erection Difficulties (QOL-MED)|The Quality of Life for men with Erection Difficulties (QOL-MED) is a cross-cultural instrument to measure quality of life specific to male erection difficulties. The 18 items for this scale were generated from interviews with men with erection difficulties by TH Wagner in 1996. Higher QOL-MED scores reflect better quality of life. Scores were standardized to range of 0 to 100.|Week 0, Week 8, Week 14|All available data expressed as absolute value at the given time-point.||units on a scale||Standard Deviation|Mean
745083|NCT00512707|Secondary|Change From Baseline in Men's Sexual Health Questionnaire (MSHQ)|MSHQ, a 25-item questionnaire, assesses sexual function and satisfaction. It consists 5 domains: Erection (3 items, ranging from 0 to 15 (best)), Ejaculation (7 items, ranging from 1 to 35 (best)), Satisfaction (6 items, ranging from 6 to 30 (best)), Sexual desire (4 items, ranging 4-20 (best)), and Sexual activity (3 items, ranging 3-15 (best)). A composite score is the sum of Ejaculation and Satisfaction domains, ranging from 7 to 65 (best), with higher score representing better sexual function and satisfaction.|Week 0, Week 8, Week 14|All available data expressed as absolute value at the given time-point.||units on a scale||Standard Deviation|Mean
745084|NCT00512707|Secondary|Change From Baseline in Successful Sexual Intercourse of Sexual Encounter Profile (SEP)|Sexual Encounter Profile (SEP) diaries were used to assess frequency of sexual activity, sildenafil use, vaginal penetration, completion of intercourse with ejaculation, and overall satisfaction with sexual encounters. Higher percentage of Ejaculations or Satisfaction in successful sexual intercourse represents better sexual function.|Week 0, week 8, week 14|All available data expressed as absolute value at the given time-point.||percentage of sexual intercourses||Standard Deviation|Mean
745085|NCT00512707|Secondary|Change From Baseline in Sexual Encounter Profile (SEP)|Sexual Encounter Profile (SEP) diaries were used to assess frequency of sexual activity, sildenafil use, vaginal penetration, completion of intercourse with ejaculation, and overall satisfaction with sexual encounters. Minimum value is 0 with no maximum limit, wherein higher values representing better sexual encounter.|Week 0, week 8, week 14|All available data expressed as absolute value at the given time-point.||events/week||Standard Deviation|Mean
745086|NCT00512707|Secondary|Change From Baseline in Other Domains of International Index of Erectile Function (IIEF)|IIEF is a validated, 15-item questionnaire that assesses 5 domains of sexual function: erectile function (range 1-30), orgasmic function (range 0-10), sexual desire (range 2-10), intercourse satisfaction (range 0-15), and overall sexual satisfaction (range 2-10). Each question was answered on a 6-point or 5-point scale from 0/1 to 5 (best) with a total possible score (sum of 5 domains) range of 5 to 75 with higher scores representing better function.|Week 0, week 8, week 11, week 14|All available data expressed as absolute value at the given time-point.||units on a scale||Standard Deviation|Mean
745087|NCT00512707|Primary|Change From Baseline in Erectile Function Domain Score of the International Index of Erectile Function (IIEF)|IIEF is a validated, 15-item questionnaire that assesses 5 domains of sexual function: erectile function (range 1-30), orgasmic function (range 0-10), sexual desire (range 2-10), intercourse satisfaction (range 0-15), and overall sexual satisfaction (range 2-10). Each question was answered on a 6-point or 5-point scale from 0/1 to 5 (best) with Erectile Function domain range of 1 to 30 with higher scores representing better function.|Week 0, week 8, week 11, week 14|All available data expressed as absolute value at the given time-point.||units on a scale||Standard Deviation|Mean
745088|NCT00507130|Secondary|Terminal Phase Half-life (T1/2)|T1/2 of MEDI-528|Days 0, 3, 7, 10, 14, 17, 21, 24, 26, 28, 31, 35, 42, 49, 56, 70, 84, 119, and 150|All subjects who received at least one dose of MEDI-528 and had blood samples analyzed for pharmacokinetic analysis||Day||Standard Deviation|Mean
745089|NCT00507130|Secondary|Observed Maximum Serum Concentration (Cmax)|Cmax of MEDI-528|Days 0, 3, 7, 10, 14, 17, 21, 24, 26, 28, 31, 35, 42, 49, 56, 70, 84, 119, and 150|All subjects who received at least one dose of MEDI-528 and had blood samples analyzed for pharmacokinetic analysis||Micrograms per milliliter||Standard Deviation|Mean
745090|NCT00507130|Secondary|Time to Observed Maximum Serum Concentration (Tmax)|Tmax of MEDI-528|Days 0, 3, 7, 10, 14, 17, 21, 24, 26, 28, 31, 35, 42, 49, 56, 70, 84, 119, and 150|All subjects who received at least one dose of MEDI-528 and had blood samples analyzed for pharmacokinetic analysis||Day||Standard Deviation|Mean
745091|NCT00507130|Secondary|Incidence of Anti-drug Antibodies (ADA) to MEDI-528|Number of participants with ADA to MEDI-528|Days 0, 28, 56, 84, 119, and 150|All subjects who received at least one dose of MEDI-528||Participants|||Number
745092|NCT00507130|Primary|Incidence of Serious Adverse Events|Number of participants experiencing serious adverse events|Days 0 - 150|All subjects who received at least one dose of investigational product (MEDI-528 or placebo)||Participants|||Number
745093|NCT00507130|Primary|Incidence of Abnormal Clinically Significant Magnetic Resonance Imaging (MRI) Results|Number of participants experiencing abnormal clinically significant MRI results|Days -14 to -1 and 28|All subjects who received at least one dose of investigational product (MEDI-528 or placebo)||Participants|||Number
745094|NCT00507130|Primary|Incidence of Abnormal Clinically Significant Electrocardiogram (ECG) Results|Number of participants with abnormal clinically significant ECG results|Days -14 to -1, 14, 28, 56, 84, and 150|All subjects who received at least one dose of investigational product (MEDI-528 or placebo)||Participants|||Number
745095|NCT00507130|Primary|Incidence of Abnormal Troponin Levels|Number of participants with troponin levels greater than upper limit of normal|Days 0, 14, 28, 56, 84, and 150|All subjects who received at least one dose of investigational product (MEDI-528 or placebo)||Participants|||Number
745096|NCT00507130|Primary|Incidence of Adverse Events|Number of participants experiencing adverse events (includes both adverse events and serious adverse events)|Days 0 - 150|All subjects who received at least one dose of investigational product (MEDI-528 or placebo)||Participants|||Number
745097|NCT00507208|Primary|Number of Participants Demonstrating Improved MIO Using Either the Dynapslint System or Tongue Depressors|Number of participants who demonstrated improved maximal incisial opening (MIO), the distance from the tips of the upper and lower incisors on maximal effort. Successful improvement is defined as > 5mm improvement from the baseline measurement.|12 months|||participants|||Number
745098|NCT00512798|Primary|Number of Patients With Clinical Anti-tumor Activity Phase II)|Per RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) > 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions. Patients with CR + PR + SD|every 9 weeks to a maximum of 54 weeks|Patients who were available to measure response to the study drugs.||participants|||Number
745099|NCT00512798|Secondary|Patients With Inhibition of NF-kB (Phase II)|Patient with a minimum of 50% reduction from baseline on day 8 or day 29 in NF-kB, measured by picograms/milliliter in peripheral mononuclear blood cells|at baseline, on day 8 and on day 29|Patients with advanced, incurable melanoma who are chemotherapy-naive and patients who had undergone prior chemotherapy with either Dacarbazine or Temozolomide with treatment failure. No degree of inhibition of NF-kB was observed. Phase II not completed due to lack of efficacy.||participants|||Number
745100|NCT00512798|Secondary|Patients With Clinical Anti-tumor Activity (Phase I)|Per RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) > 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions|every 9 weeks up to a maximum of 54 weeks|Patients who received treatment and who were available for measurement of lesions.||participants|||Number
745110|NCT00513019|Primary|The Yale-Brown Obsessive Compulsive Scale Modified for Neurotic Excoriation (NE-YBOCS) Will be the Primary Outcome Measure|The Yale-Brown Obsessive Compulsive Scale Modified for Neurotic Excoriation (NE-YBOCS) was the primary outcome measure - severity of illness. The NE-YBOCS is a reliable and valid, 10-item, clinician-administered scale that rates buying symptoms within the last seven days, on a severity scale from 0 to 4 for each item (total scores range from 0 to 40 with higher scores reflecting greater illness severity).|beginning and at each visit until the end of their participation in the study (12-weeks); investigator rated. Note: Reported mean and standard deviation is the final reported data point.|||units on a scale||Standard Deviation|Mean
745111|NCT00513071|Secondary|N-telopeptide and Deoxypyridinoline as Prognostic Bone Markers||At baseline, at 6 hours, at each course (day 1), and at 2 years||||||
745112|NCT00513071|Secondary|Relationship Between Changes in Laboratory Correlates and Response and Survival||Up to 2 years||||||
745113|NCT00513071|Secondary|Toxicity as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0||Up to 2 years||||||
745114|NCT00513071|Secondary|Overall Survival||Up to 2 years||||||
745115|NCT00513071|Secondary|Time to Treatment Failure||Up to 2 years||||||
745116|NCT00513071|Secondary|Progression-free Survival (PFS) According to RECIST|PFS defined as time between registration and disease progression or death. Using the method of Kaplan-Meier.|Up to 2 years|||Months||95% Confidence Interval|Median
745117|NCT00513071|Primary|PSA Response Rate|Complete Response (CR), disappearance of all measurable and non-measurable disease. No new lesions. PSA ≤ 0.2 ng/mL; Partial Response (PR), a decline in PSA by at least 30%, confirmed by a second PSA value four or more weeks later; Overall Response (OR) = CR + PR|PSA measured every 4 weeks|||percentage of participants|||Number
745118|NCT00514501|Primary|Sensitivity, Specificity of Detecting Myocardial Ischemia (Reader 3)|"Enrolled subjects were imaged (10 minutes post-injection) using iodofiltic acid I 123 SPECT and the resulting data were reviewed in blinded reads by readers independent of the study centers and the Sponsor. The results obtained in these blinded reads were compared with the final diagnosis for each subject with regard to myocardial ischemia or ACS, determined by the Final Diagnosis Clinical Endpoints Committee (FDCEC).
Sensitivity = % (n/N): N = number of subjects positive for ischemia per the FDCEC; n = subset of N positive for ischemia per the blinded Majority Read (two of three readers) of iodofiltic acid I 123 readers.
Specificity = % (n/N): N = number of subjects negative for ischemia per the FDCEC; n = subset of N negative for ischemia per the blinded Majority Read (two of three readers) of iodofiltic acid I 123 readers."|Day 30|The study enrolled a total of 510 subjects; 507 of these subjects received iodofiltic acid I 123, and 506 had iodofiltic acid I 123 SPECT images available. Of the 507 subjects who were dosed, 342 were eligible for efficacy evaluation.||% (n/N)||95% Confidence Interval|Number
745119|NCT00514501|Primary|Sensitivity, Specificity of Detecting Myocardial Ischemia (Reader 2)|"Enrolled subjects were imaged (10 minutes post-injection) using iodofiltic acid I 123 SPECT and the resulting data were reviewed in blinded reads by readers independent of the study centers and the Sponsor. The results obtained in these blinded reads were compared with the final diagnosis for each subject with regard to myocardial ischemia or ACS, determined by the Final Diagnosis Clinical Endpoints Committee (FDCEC).
Sensitivity = % (n/N): N = number of subjects positive for ischemia per the FDCEC; n = subset of N positive for ischemia per the blinded Majority Read (two of three readers) of iodofiltic acid I 123 readers.
Specificity = % (n/N): N = number of subjects negative for ischemia per the FDCEC; n = subset of N negative for ischemia per the blinded Majority Read (two of three readers) of iodofiltic acid I 123 readers."|Day 30|The study enrolled a total of 510 subjects; 507 of these subjects received iodofiltic acid I 123, and 506 had iodofiltic acid I 123 SPECT images available. Of the 507 subjects who were dosed, 342 were eligible for efficacy evaluation.||% (n/N)||95% Confidence Interval|Number
745120|NCT00514501|Primary|Sensitivity, Specificity of Detecting Myocardial Ischemia (Reader 1)|"Enrolled subjects were imaged (10 minutes post-injection) using iodofiltic acid I 123 SPECT and the resulting data were reviewed in blinded reads by readers independent of the study centers and the Sponsor. The results obtained in these blinded reads were compared with the final diagnosis for each subject with regard to myocardial ischemia or ACS, determined by the Final Diagnosis Clinical Endpoints Committee (FDCEC).
Sensitivity = % (n/N): N = number of subjects positive for ischemia per the FDCEC; n = subset of N positive for ischemia per the blinded Majority Read (two of three readers) of iodofiltic acid I 123 readers.
Specificity = % (n/N): N = number of subjects negative for ischemia per the FDCEC; n = subset of N negative for ischemia per the blinded Majority Read (two of three readers) of iodofiltic acid I 123 readers."|Day 30|The study enrolled a total of 510 subjects; 507 of these subjects received iodofiltic acid I 123, and 506 had iodofiltic acid I 123 SPECT images available. Of the 507 subjects who were dosed, 342 were eligible for efficacy evaluation.||% (n/N)||95% Confidence Interval|Number
745121|NCT00514514|Secondary|Efficacy Event Data After Month 12 to Month 60|Efficacy events were: Biopsy-proven acute rejection (BPAR), graft loss, death, and treatment failure (defined as composite endpoint of BPAR, graft loss, death, loss to follow-up, discontinuation due to lack of efficacy or due to toxicity).|Events starting after Month 12|The Intention-to-treat (ITT) Population consisted of all patients who were randomized at BL2 (Month 3), and who received at least one dose of randomized treatment. Patients were analyzed according to their assigned treatment. The ITT population might have included patients without any data after randomization.||Participants|||Number
745122|NCT00514514|Secondary|Mean Change in Serum Creatinine From Month 3 to Month 60|Change in venous blood serum creatinine. Last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model|From randomization at BL2 (Month 3) to Month 60 post-transplant|Participants analyzed were previously enrolled in the core study and had at least one serum creatinine value in the extension period.||mg/dl||95% Confidence Interval|Least Squares Mean
745148|NCT00514683|Secondary|Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Domain Score Activities|"Change from baseline in Saint George's Respiratory Questionnaire (SGRQ) domain score activities. Scores range from 0 to 100, with higher scores indicating worst possible health status.
Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region."|Baseline and 52 weeks|LOCF-Randomised set||units on a scale||Standard Error|Mean
745245|NCT00515008|Secondary|Mean Change From Baseline CPSS Score|The Chronic Pain Self-Efficacy Scale (CPSS) is a self-report score measuring self-efficacy with respect to chronic pain (range, 1 to 10, with higher scores indicating greater self-efficacy).|12 weeks|||units on a scale||95% Confidence Interval|Mean
745123|NCT00514514|Secondary|GFR at Month 60 Utilizing Modification of Diet in Renal Disease (MDRD) Method|"Change in GFR (Modification of Diet in Renal Disease calculated using the –MDRD formulat:
For men: GFR = 170 × (serum creatinine -0,999)×(age-0,176) x (urea nitrogen -0,17) × (albumin0,318) For women: GFR = 170 × (serum creatinine -0,999) × (age-0,176) × (urea nitrogen -0,17) x (albumin0,318) × 0.762 with urea nitrogen = urea / 2.144. ), last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model, with treatment, center, donor type (deceased vs. living) as factors and BL2-value at V4/M3/BL2 as covariate."|From randomization at BL2 (Month 3) to Month 60 post-transplant|Participants analyzed differs due to different input values requested by the different formulas (Nankivell, MDRD and Cockcroft-Gault). ITT Population consisted of all patients who were randomized at Month 3 who received at least one dose of randomized treatment. The ITT population might have included patients without any data after randomization||ml/min/1.73m²||95% Confidence Interval|Least Squares Mean
745124|NCT00514514|Secondary|GFR at Month 60 Utilizing Cockcroft-Gault Formula|Cockcroft-Gault formula: For men: GFR= ((140-age) × body weight in kg)∕(72 x serum creatinine in mg∕dl) For women: GFR= (0.85×(140-age) × body weight in kg)∕(72 x serum creatinine in mg/dl), ), last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model|From randomization at BL2 (Month 3) to Month 60 post-transplant|Participants analyzed differs due to different input values requested by the different formulas (Nankivell, MDRD and Cockcroft-Gault). ITT Population consisted of all patients who were randomized at Month 3 who received at least one dose of randomized treatment. The ITT population might have included patients without any data after randomization||ml/min/1.73m²||95% Confidence Interval|Least Squares Mean
745125|NCT00514514|Secondary|GFR Calculated Via Nankivell Formula at Month 60|Change in GFR using the Nankivell formula (GFR = 6.7 / Scr + BW / 4 – Surea / 2-100 / (height)² + C where where Scr is the serum creatinine concentration expressed in mmol/L, BW the body weight in kilograms, Surea the serum urea in mmol/L, height in m, and the constant C is 35 for male and 25 for female patients. The calculated GFR is expressed in mL/min per 1.73m², last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model, with treatment, center, donor type (deceased vs. living) as factors and BL2-value at V4/M3/BL2 as covariate.|From randomization at BL2 (Month 3) to Month 60|Participants analyzed differs due to different input values requested by the different formulas (Nankivell, MDRD and Cockcroft-Gault). ITT Population consisted of all patients who were randomized at Month 3 who received at least one dose of randomized treatment. The ITT population might have included patients without any data after randomization||ml/min/1.73m²||95% Confidence Interval|Least Squares Mean
745126|NCT00514514|Secondary|Change From BL2 (Month 3) to Month 12 in Cardiovascular Risk (Framingham Score; 10-year Cardiovascular Risk)|The Framingham Score (based on LDL cholesterol level) estimates the coronary heart disease risk (%) of developing one of the following coronary heart diseases: angina pectoris, myocardial infarction, or coronary disease death, over the course of 10 years.|From Baseline 2 (Month 3) to Month 12|The Intention-to-treat (ITT) Population consisted of all patients who were randomized at BL2 (Month 3), and who received at least one dose of randomized treatment. Patients were analyzed according to their assigned treatment. The ITT population might have included patients without any data after randomization.||Percent risk||Standard Deviation|Mean
745127|NCT00514514|Secondary|Efficacy Event Data Baseline 2 (Month 3) to Month 12|Efficacy events were: Biopsy-proven acute rejection (BPAR), graft loss, death, and treatment failure (defined as composite endpoint of BPAR, graft loss, death, loss to follow-up, discontinuation due to lack of efficacy or due to toxicity).|From Baseline 2 (Month 3) to Month 12|The Intention-to-treat (ITT) Population consisted of all patients who were randomized at BL2 (Month 3), and who received at least one dose of randomized treatment. Patients were analyzed according to their assigned treatment. The ITT population might have included patients without any data after randomization.||Participants|||Number
745128|NCT00514514|Secondary|Efficacy Event Data From Baseline 2 (Month 3) to Month 6|Efficacy events were: Biopsy-proven acute rejection (BPAR), graft loss, death, and treatment failure (defined as composite endpoint of BPAR, graft loss, death, loss to follow-up, discontinuation due to lack of efficacy or due to toxicity).|From Baseline 2 (Month 3) to Month 6|The Intention-to-treat (ITT) Population consisted of all patients who were randomized at BL2 (Month 3), and who received at least one dose of randomized treatment. Patients were analyzed according to their assigned treatment. The ITT population might have included patients without any data after randomization.||Participants|||Number
745129|NCT00514514|Secondary|Mean Change in Serum Creatinine From Month 3 to Month 12|Change in venous blood serum creatinine. Last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model|From randomization at BL2 (Month 3) to Month 12 post-transplant|Participants analyzed required at least one post randomization value. ITT Population consisted of all patients who were randomized at Month 3 who received at least one dose of randomized treatment. The ITT population might have included patients without any data after randomization||mg/dl||95% Confidence Interval|Least Squares Mean
745130|NCT00514514|Secondary|GFR at Month 12 Utilizing Cockcroft-Gault Formula|Cockcroft-Gault formula: For men: GFR= ((140-age) × body weight in kg)∕(72 x serum creatinine in mg∕dl)For women: GFR= (0.85×(140-age) × body weight in kg)∕(72 x serum creatinine in mg/dl), ), last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model|From randomization at BL2 (Month 3) to Month 12 post-transplant|Participants analyzed differs due to different input values requested by the different formulas (Nankivell, MDRD and Cockcroft-Gault). ITT Population consisted of all patients who were randomized at Month 3 who received at least one dose of randomized treatment. The ITT population might have included patients without any data after randomization.||ml/min/1.73m²||95% Confidence Interval|Least Squares Mean
745149|NCT00514683|Secondary|Change From Baseline in SGRQ Domain Score Impacts|"Change from baseline in Saint George's Respiratory Questionnaire (SGRQ) domain score impacts. Scores range from 0 to 100, with higher scores indicating worst possible health status.
Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region."|Baseline and 52 weeks|LOCF - Randomised set||units on a scale||Standard Error|Mean
745150|NCT00514683|Secondary|Change From Baseline in SGRQ Domain Score Symptoms|"Change from baseline in Saint George's Respiratory Questionnaire (SGRQ) domain score symptoms. Scores range from 0 to 100, with higher scores indicating more limitations.
Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region."|Baseline and 52 weeks|LOCF-Randomised set||units on a scale||Standard Error|Mean
745131|NCT00514514|Secondary|GFR at Month 12 Utilizing Modification of Diet in Renal Disease (MDRD) Method|"Change in GFR (Modification of Diet in Renal Disease calculated using the –MDRD formulat:
For men: GFR = 170 × (serum creatinine -0,999)×(age-0,176) x (urea nitrogen -0,17) × (albumin0,318) For women: GFR = 170 × (serum creatinine -0,999) × (age-0,176) × (urea nitrogen -0,17) x (albumin0,318) × 0.762 with urea nitrogen = urea / 2.144. ), last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model, with treatment, center, donor type (deceased vs. living) as factors and BL2-value at V4/M3/BL2 as covariate."|From randomization at BL2 (Month 3) to Month 12 post-transplant|Participants analyzed differs due to different input values requested by the different formulas (Nankivell, MDRD and Cockcroft-Gault). ITT Population consisted of all patients who were randomized at Month 3 who received at least one dose of randomized treatment. The ITT population might have included patients without any data after randomization.||ml/min/1.73m²||95% Confidence Interval|Least Squares Mean
745132|NCT00514514|Secondary|GFR Via Nankivell Formula at Month 12 - All Regimens|Change in GFR using the Nankivell formula (GFR = 6.7 / Scr + BW / 4 – Surea / 2-100 / (height)² + C where where Scr is the serum creatinine concentration expressed in mmol/L, BW the body weight in kilograms, Surea the serum urea in mmol/L, height in m, and the constant C is 35 for male and 25 for female patients. The calculated GFR is expressed in mL/min per 1.73m², last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model, with treatment, center, donor type (deceased vs. living) as factors and BL2-value at V4/M3/BL2 as covariate.|From randomization at BL2 (Month 3) to Month 12 post-transplant|Participants analyzed differs due to different input values requested by the different formulas (Nankivell, MDRD and Cockcroft-Gault). ITT Population consisted of all patients who were randomized at Month 3 who received at least one dose of randomized treatment. The ITT population might have included patients without any data after randomization.||ml/min/1.73m²||95% Confidence Interval|Least Squares Mean
745133|NCT00514514|Primary|GFR Via Nankivell Method at Month 12 - CNI-Free vs Standard Regimen|Demonstrate superiority of CNI-Free vs Standard Regimen in GFR using the Nankivell formula (GFR = 6.7 / Scr + BW / 4 – Surea / 2-100 / (height)² + C where where Scr is the serum creatinine concentration expressed in mmol/L, BW the body weight in kilograms, Surea the serum urea in mmol/L, height in m, and the constant C is 35 for male and 25 for female patients. The calculated GFR is expressed in mL/min per 1.73m², last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model, with treatment, center, donor type (deceased vs. living) as factors and BL2-value at V4/M3/BL2 as covariate. P-values are not adjusted|From randomization at BL2 (Month 3) to Month 12 post-transplant|Participants analyzed differs due to different input values requested by the different formulas (Nankivell, MDRD and Cockcroft-Gault). ITT Population consisted of all patients who were randomized at Month 3 who received at least one dose of randomized treatment. The ITT population might have included patients without any data after randomization.||ml/min/1.73m²||95% Confidence Interval|Least Squares Mean
745134|NCT00514592|Secondary|Any Stroke Before Carotid Enderarterectomy|Same as primary endpoint, but includes stroke of all types.|Before CEA|||participants|||Number
745135|NCT00514592|Primary|Ipsilateral Ischemic Stroke Before Carotid Endarterectomy|Ipsilateral ischemic stroke after the presenting event. Only events that occurs within 90 days and before Carotid EndArterectomy (CEA) is used.|Before CEA|||participants|||Number
745136|NCT00514683|Secondary|Pre-dose Plasma Concentration of Nintedanib in Plasma at Steady State on Day 365 (Cpre,ss,365) and Day 729 (Cpre,ss,729).|Cpre,ss,729 represents the pre-dose plasma concentration of nintedanib in plasma at steady state on Day 729 and Cpre,ss,365 represents the pre-dose plasma concentration of nintedanib in plasma at steady state on Day 365. At day 365, values only for Nintedanib 50 qd group are presented as no values reported for other groups and at day 729, values are presented for all group except for Nintedanib 50 qd group as no values reported for it.|day 365 and day 729|Randomised set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
745137|NCT00514683|Secondary|Time to Progression|"Time to progression. Progression was defined as at least one of the following: 5mmHg increase in the alveolo-arterial pressure difference in oxygen (P(A-a)O2), 10% decrease in FVC (FVC(baseline)-FVC(progression) >= 10%) or Death.
Failure means participants with event and Censored means participants with no event."|52 weeks|OC - Randomised set||Days||95% Confidence Interval|Median
745138|NCT00514683|Secondary|Survival (Death Due to Respiratory Cause, and Lung-transplant Free)|"Survival (death due to respiratory cause, and lung-transplant free) at 52 weeks.
Failure means participants with event and Censored means participants with no event."|52 weeks|OC-Randomised set||percentage of participants|||Number
745139|NCT00514683|Secondary|Time to First Occurrence of IPF Exacerbation|"This endpoint is called time to first occurrence of IPF exacerbation however it was actually analysed as the proportion of patients having occurrence of Idiopathic Pulmonary Fibrosis (IPF) exacerbation at 52 weeks.
Failure means participants with event and Censored means participants with no event."|52 weeks|OC-Randomised set||percentage of participants|||Number
745140|NCT00514683|Secondary|Occurrences of IPF Exacerbations Per Patient Per Year|Occurrences of Idiopathic Pulmonary Fibrosis (IPF) exacerbations per patient per year at 52 weeks|52 weeks|OC-Randomised set||Exacerbations Per Year||Standard Deviation|Mean
745141|NCT00514683|Secondary|Number of Patients With at Least One IPF Exacerbation|Number of patients with at least one Idiopathic Pulmonary Fibrosis (IPF) exacerbation at 52 weeks|52 weeks|OC-Randomised set||participants|||Number
745142|NCT00514683|Secondary|Change From Baseline in IC|Change from Baseline in Inspiratory Capacity (IC) at 52 weeks. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.|Baseline and 52 weeks|LOCF-Randomised set||Liters||Standard Error|Mean
745143|NCT00514683|Secondary|Change From Baseline in VC|Change from baseline in Vital capacity (VC) at 52 weeks. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.|Baseline and 52 weeks|LOCF-Randomised set||Liters||Standard Error|Mean
745144|NCT00514683|Secondary|Change From Baseline in TGV|Change from Baseline in Thoracic gas volume (TGV) at 52 weeks. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.|Baseline and 52 weeks|LOCF-Randomised set||Liters||Standard Error|Mean
745145|NCT00514683|Secondary|Change From Baseline in RV|Change from Baseline in Residual volume (RV) at 52 weeks. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.|Baseline and 52 weeks|LOCF-Randomised set||Liters||Standard Error|Mean
749183|NCT00541658|Secondary|Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 26, ITT Population||Week 26|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
745151|NCT00514683|Secondary|Change From Baseline in SGRQ Total Score|"Change from baseline in Saint George's Respiratory Questionnaire (SGRQ) total score. Total score is defined as sum of the three domain scores symptoms, activities and impacts. Scores range from 0 to 100, with higher scores indicating worst possible health status.
Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region."|Baseline and 52 weeks|LOCF-Randomised set||units on a scale||Standard Error|Mean
745152|NCT00514683|Secondary|Absolute Change From Baseline in FEV1/FVC|"Change from baseline of percentage of FVC expelled in the first second of a forced expiration (FEV1/FVC) at 52 weeks.
Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region."|Baseline and 52 weeks|LOCF-Randomised set||percentage of FVC||Standard Error|Mean
745153|NCT00514683|Secondary|Absolute Change From Baseline in MRC Dyspnea Scale by Categories|"Absolute change from baseline in Medical Research Council (MRC) dyspnea scale by below mentioned categories:
Decrease
No Change
Increase"|Baseline and 52 weeks|LOCF- Randomised||percentage of participants|||Number
745154|NCT00514683|Secondary|Change From Baseline in Dyspnoea Rating on Borg Scale After Exercise (6-MWT)|"Change from baseline in Dyspnoea rating after exercise (6-MWT) at 52 weeks based on Borg scale as mentioned below :
0: Nothing at all, 0.5: Very, very slight (just noticable), 1: Very slight, 2: Slight (light), 3: Moderate, 4: Somewhat severe, 5: Severe (heavy), 6, 7:Very severe, 8, 9, 10: Very, very severe (Maximal).
The 6-Minutes Walk Test (6-MWT) was conducted according to the ATS Criteria. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region."|Baseline and 52 weeks|LOCF-Randomised set||Units on a scale||Standard Error|Mean
745155|NCT00514683|Secondary|Absolute Change From Baseline in Dyspnoea Rating on Borg Scale Before Exercise (6-MWT)|"Absolute change from baseline in Dyspnoea rating before exercise (6-MWT) at 52 weeks based on Borg scale as mentioned below :
0: Nothing at all, 0.5: Very, very slight (just noticable), 1: Very slight, 2: Slight (light), 3: Moderate, 4: Somewhat severe, 5: Severe (heavy), 6, 7:Very severe, 8, 9, 10: Very, very severe (Maximal).
The 6-Minutes Walk Test (6-MWT) was conducted according to the ATS Criteria. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region."|Baseline and 52 weeks|LOCF-Randomised set||Units on a scale||Standard Error|Mean
745156|NCT00514683|Secondary|Absolute Change From Baseline in Distance Walk (6-MWT)|Absolute change from baseline in distance walk (6-MWT) at 52 weeks. The 6-Minutes Walk Test (6-MWT) was conducted according to the American Thoracic Society (ATS) Criteria. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.|Baseline and 52 weeks|LOCF-Randomised set||Meter||Standard Error|Mean
745157|NCT00514683|Secondary|Absolute Change From Baseline in DLCO by Categories|"Absolute change from baseline in Diffusing capacity of the lung for carbon monoxide (DLCO) by below mentioned categories:
Decrease > 15% or > 1
Change <= 15% or <= 1
Increase > 15% or > 1"|Baseline and 52 weeks|LOCF Randomized set||percentage of patients|||Number
745158|NCT00514683|Secondary|Absolute Change From Baseline in DLCO|"Absolute change from Baseline in Diffusing capacity of the lung for carbon monoxide (DLCO) at 52 weeks.
Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region."|Baseline and 52 weeks|LOCF-Randomised set||mmol.min^−1.kPa^−1||Standard Error|Mean
745159|NCT00514683|Secondary|Absolute Change From Baseline in P(A-a) O2 by Categories|"Absolute change from baseline in Alveolo-arterial oxygen gradient (P(A-a) O2) by below mentioned categories:
Decrease > 4 mmHg
Change within +/- 4 mmHg
Increase > 4 mmHg"|Baseline and 52 weeks|OC - Randomised set||percentage of participants|||Number
745160|NCT00514683|Secondary|Absolute Change From Baseline in PaO2 by Categories|"Absolute change from baseline in Arterial oxygen partial pressure (PaO2) by below mentioned categories:
Decrease > 4 mmHg
Change within +/- 4 mmHg
Increase > 4 mmHg"|Baseline and 52 weeks|OC - Randomised set||percentage of participants|||Number
745161|NCT00514683|Secondary|Absolute Change From Baseline in PaCO2|Absolute change from baseline in Arterial carbon dioxyde partial pressure (PaCO2) at week 52. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.|Baseline and 52 weeks|OC-Randomised set||mmHg||Standard Error|Mean
745162|NCT00514683|Secondary|Absolute Change From Baseline in P(A-a)O2|Absolute change from baseline in Alveolo-arterial oxygen gradient (P(A-a)O2) at week 52. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.|Baseline and 52 weeks|OC-Randomised set||mmHg||Standard Error|Mean
745163|NCT00514683|Secondary|Absolute Change From Baseline in PaO2|Absolute change from baseline in Arterial oxygen partial pressure (PaO2) at week 52. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.|Baseline and 52 weeks|OC-Randomised set||mmHg||Standard Error|Mean
745164|NCT00514683|Secondary|Absolute Change From Baseline in SpO2 at Rest by Categories|"Absolute change from baseline in oxygen saturation (SpO2) at rest by below mentioned categories:
SpO2 (non-invasive) at 52 weeks:
Decrease > 4% SpO2
Change within +/- 4% SpO2
Increase > 4% SpO2"|Baseline and 52 weeks|LOCF-Randomised set||percentage of participants|||Number
745165|NCT00514683|Secondary|Absolute Change From Baseline in SpO2 at Rest|"Absolute change from baseline in oxygen saturation (SpO2) at rest.
Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region."|Baseline and 52 weeks|LOCF-Randomised set||Percentage of SpO2||Standard Error|Mean
745166|NCT00514683|Secondary|Survival (All Causes of Death and Lung-transplant Free)|"Survival (all causes of death and lung-transplant free) at 52 weeks, based on overall mortality and on-treatment survival.
Failure means participants with event and Censored means participants with no event."|52 weeks|OC-Randomised set||participants|||Number
745167|NCT00514683|Secondary|Number of Participants With Change From Baseline in FVC by Categories|"Change from baseline in percentage of Forced Vital Capacity (FVC) at 52 weeks in below mentioned categories:
Decrease > 10% or 200mL
Change within <= 10% or <=200 mL
Increase > 10% or 200mL"|Baseline and 52 weeks|LOCF-Randomised set||participants|||Number
745168|NCT00514683|Secondary|Relative Change From Baseline in FVC|"Percent change from baseline in absolute Forced Vital Capacity (FVC) at 52 weeks.
Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline and region"|Baseline and 52 weeks|LOCF-Randomised set||percentage change||Standard Error|Mean
745169|NCT00514683|Secondary|Relative Change From Baseline in FVC%Pred|"Percent change from baseline in percentage of predicted Forced Vital Capacity (FVC%pred) at 52 weeks.
Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline and region."|Baseline and 52 weeks|LOCF-Randomised set||percentage of change||Standard Error|Mean
753201|NCT00566982|Primary|Mean Change From Baseline in Percentage of Parabasal Cells in Maturation Index of Vaginal Smear||12 weeks|ITT||percentage of parabasal cells||Standard Deviation|Mean
745171|NCT00514683|Secondary|Absolute Change From Baseline in FVC%Pred|"Change from baseline in percentage of predicted Forced Vital Capacity (FVC%pred) at 52 weeks.
Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline and region."|Baseline and 52 weeks|"Last Observation Carried Forward (LOCF): This method was used for the replacement of missing values.
Randomised set: This patient set includes all randomised patients whether treated or not."||percentage of predicted FVC||Standard Error|Mean
745172|NCT00514683|Primary|Rate of Decline in FVC|"Rate of decline in Forced Vital Capacity (FVC) evaluated from baseline until 52 weeks of treatment.
The means presents actually the adjusted rate based on a MMRM with fixed terms for treatment*time, gender*height, gender*age and random terms for patient effect, patient*time."|Baseline until 52 weeks|"Observed Case (OC): This method was used for the replacement of missing values.
Randomised set: This patient set includes all randomised patients whether treated or not."||Liters/year||Standard Error|Mean
745173|NCT00514709|Secondary|Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV)|"Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions; Pyrexia (temperature), Vomiting, Abnormal Crying, Drowsiness, Loss of Appetite, and irritability.
Grade 3 reactions are defined as: Pain - cries when injected limb is moved; Erythema and Swelling - ≥ 5cm; Fever - rectal temperature ≥ 39.5ºC; Vomiting - ≥6 episodes per 24 hours; Crying - inconsolable crying for >3 hours; Somnolence - sleeping most of the time or difficulty to wake up; Anorexia - refuses ≥3 feeds; and Irritability - inconsolable."|Day 0 up to Day 7 after vaccination|Safety was assessed on the safety analysis (intent-to-treat) population.||Participants|||Number
745174|NCT00514709|Secondary|Geometric Mean Titers (GMTs) of Vaccine Antibodies After Booster Vaccination With DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV)|Immunogenicity was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-PRP antibodies, enzyme immunoassay (EIA) for anti-Tetanus, and serum neutralization (SN) for anti-Diphtheria following the booster vaccination.|Day 0 (pre-vaccination) and Day 28 post-vaccination|GMTs were assessed in a sub-set of the participants available for the endpoint, the per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
745175|NCT00514709|Primary|Number of Participants With Antibody Persistence and Immunogenicity Booster Response to Vaccination With DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV)|"Immunogenicity was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-PRP antibodies, enzyme immunoassay (EIA) for anti-Tetanus, and serum neutralization (SN) for anti-Diphtheria.
Booster responses defined as titers ≥ 10 mIU/mL for anti-Hep Bs; ≥ 0.15 μg/mL for anti-PRP; ≥ 0.01 IU/mL for anti-Tetanus and anti-Diphtheria; Pertussis Toxoid and Filamentous Hemagglutinin (FHA) 4-fold increase and booster response."|Day 0 (pre-vaccination) and Day 28 post-booster vaccination|Antibody persistence and immunogenicity booster responses were assessed in a subset of participants available for the endpoint, the per-protocol population.||Participants|||Number
745176|NCT00514735|Secondary|Improved Quality of Life Over 6 Months Compared to Baseline.|The SF-36 questionnaire was administered to subjects at baseline, 1, 3 and 6 month visits. The SF-36 is a multi-purpose, short-form health survey with only 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based Physical Component Score and Mental Component Score. The possible range for Physical Component Score and Mental Component Score is 0 to 100. The higher score, the better quality of life.|6 months|An Intention to Treat (ITT) analysis was performed in which all data was analyzed according to the subject’s assigned randomization group.||Scores on a scale||Standard Deviation|Mean
745177|NCT00514735|Secondary|Improvement in Atrial Fibrillation (AF) Symptom Severity Scores Over 6 Months Compared to Baseline.|The severity of subject's atrial fibrillation related symptoms on a scale from 1 (no symptoms) to 5 (most severe). The symptoms included palpitations, fatigue, shortness of breath, lightheadedness or dizziness, and lack of energy during exertion or exercise. The scores were tabulated at the 1, 3 and 6 month follow-up visits. Scores could range from 5 to 25, indicating a spectrum of subject status from asymptomatic to severely symptomatic.|6 months|An Intention to Treat (ITT) analysis was performed in which all data was analyzed according to the subject’s assigned randomization group.||AF Symptom Severity Score||Standard Deviation|Mean
745178|NCT00514735|Secondary|Improvement of Left Ventricular Ejection Fraction at 6 Months Compared to Baseline.|Left ventricular ejection fraction (LVEF), as measured by transthoracic echocardiogram at baseline and 6 months in both the Ablation and Medical Management arms.|6 months|An Intention to Treat (ITT) analysis was performed in which all data was analyzed according to the subject’s assigned randomization group.||percent||Standard Deviation|Mean
745179|NCT00514735|Secondary|Improvement of Left Atrial Size at 6 Months Compared to Baseline.|Left atrial diameter (LAD), as measured by transthoracic echocardiogram (TTE) looking at the longitudinal long axis at baseline and at the 6 month follow-up visit in both the Ablation and Medical Management arms.|6 months|An Intention to Treat (ITT) analysis was performed in which all data was analyzed according to the subject’s assigned randomization group. The primary missing value imputation technique for all primary endpoint analyses was the passive method of imputation.||centimeters||Standard Deviation|Mean
745180|NCT00514735|Secondary|Acute Efficacy|"A treatment success/failure up to the conclusion of the procedure for each subject in Ablation Management. A subject was considered successfully treated if the following were true:
Medtronic ablation catheters were used to achieve procedure success.
All accessible pulmonary veins were isolated.
At least 50% reduction of complex fractionated atrial electrograms mapped and ablated with Medtronic ablation catheters.
Sinus rhythm was achieved upon leaving the electrophysiology lab (±cardioversion)."|Procedure conclusion|An Intention to Treat (ITT) analysis was performed in which all data was analyzed according to the subject’s assigned randomization group. The primary missing value imputation technique for all primary endpoint analyses was the passive method of imputation.||percentage of participants||95% Confidence Interval|Mean
745197|NCT00514904|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability /incapacity or are a congenital anomaly/ birth defect in the offspring of a study subject.|From Day 0 up to 6 months after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Participants|||Count of Participants
745181|NCT00514735|Primary|Chronic Safety|The primary endpoint for chronic safety was a success/failure variable calculated for each subject at 6 months. Any subject that had at least one adverse event that met designated seriousness and relatedness criteria for the particular treatment group as adjudicated by the Data Safety Monitoring Board was considered a chronic safety failure. Adverse events in Ablation Management that were acute (≤7 days) were not included in the chronic safety primary endpoint. Given the disparity in the length of time at risk between treatment arms,the Chronic Safety endpoint was not statistically powered.|6 months|An Intention to Treat (ITT) analysis was performed in which all data was analyzed according to the subject’s assigned randomization group. The primary missing value imputation technique for all primary endpoint analyses was the passive method of imputation.||participants|||Number
745182|NCT00514735|Primary|Acute Safety|The primary endpoint for acute safety was a success/failure variable calculated for each subject in Ablation Management at the 7 day post-procedure time point. Any subject with at least one adverse event adjudicated by the Data Safety Monitoring Board as both serious and either probably or definitely procedure and/or device-related occurring within 7 days of the ablation procedure was considered an acute safety failure, regardless of whether the event occurred following the index or retreatment ablation procedure.|7 days|An Intention to Treat (ITT) analysis was performed in which all data was analyzed according to the subject’s assigned randomization group.||percentage of participants||95% Confidence Interval|Mean
745183|NCT00514735|Primary|Chronic Effectiveness|"The chronic efficacy endpoint was a treatment success/failure measure for each subject computed at 6 months. Treatment success included:
A 90% reduction in clinically significant atrial fibrillation from baseline to the 6 month time point based on a Holter recording. Clinically significant atrial fibrillation was defined as sustained atrial fibrillation lasting more than 10 minutes.
The subject was off all antiarrhythmic drugs at 6 months (Ablation Management arm only)
The Investigator judged all procedures to be acutely successful (Ablation Management arm only)."|6 months|An Intention to Treat (ITT) analysis was performed in which all data was analyzed according to the subject’s assigned randomization group. The primary missing value imputation technique for all primary endpoint analyses was the passive method of imputation.||percentage of participants with success|||Number
745184|NCT00514813|Secondary|Change From Baseline in Hematocrits at 2 Years||Baseline and 2 years|This study was terminated on July 31, 2008 as a result of a decision by Shire Pharmaceutical to permanently cease marketing Dynepo and withdraw the Marketing Authorisation. The decision was for commercial reasons, it was not the result of any safety signal.|||||
745185|NCT00514813|Secondary|Change From Baseline in Hemoglobin (Hb) Concentrations at 2 Years||Baseline and 2 years|This study was terminated on July 31, 2008 as a result of a decision by Shire Pharmaceutical to permanently cease marketing Dynepo and withdraw the Marketing Authorisation. The decision was for commercial reasons, it was not the result of any safety signal.|||||
745186|NCT00514813|Primary|Rate of Emergence of Treatment Emergent Adverse Events (TEAEs)||Over the course of 2 Years|This study was terminated on July 31, 2008 as a result of a decision by Shire Pharmaceutical to permanently cease marketing Dynepo and withdraw the Marketing Authorisation. The decision was for commercial reasons, it was not the result of any safety signal.|||||
745187|NCT00514852|Secondary|Change From Baseline at Day 30 in Subjective Evaluation of Symptom of Dryness Score|Measures dry eye severity on a scale of 0-4 (0 = none, 4 = severe)|Change from baseline at Day 30|Intent to Treat Population||Units on a scale||Standard Deviation|Mean
745188|NCT00514852|Secondary|Change From Baseline at Day 30 in Ocular Surface (Conjunctival) Staining With Fluorescein|Sum of conjunctival staining over 6 zones; each zone was measured on a modified Oxford Scheme of 0-5 (0=no staining, 5=most severe staining), with total score from 0-30 (0=no staining, 30=most severe staining)|Change from baseline at Day 30|Intent to Treat Population||Units on a scale||Standard Deviation|Mean
745189|NCT00514852|Secondary|Change From Baseline at Day 30 in Ocular Surface (Corneal) Staining With Fluorescein|Sum of corneal staining over 5 zones; each zone was measured on a modified Oxford Scheme of 0-5 (0=no staining, 5=most severe staining), with total score from 0-25 (0= no staining, 25 = most severe staining)|Change from baseline at Day 30|Intent to Treat Population||Units on a scale||Standard Deviation|Mean
745190|NCT00514852|Post-Hoc|Ocular Surface Staining With Fluorescein (Central Cornea) at Day 30|Central staining score is based on modified Oxford Scheme measured on a scale of 0-5 (0= no staining, 5= most severe staining)|Day 30|Intent to Treat Population||Units on a scale||Standard Deviation|Mean
745191|NCT00514852|Post-Hoc|Vision Subscale of the Ocular Surface Disease Index Questionnaire© at Day 30|Vision subscale of the Ocular Surface Disease Index Questionnaire© is measured on 6 domains; a 5-point scale (0-4) for each domain. Sum of the domain scores is normalized to a severity scale of 0-100 (0 = no symptoms, 100 = maximum severity)|Day 30|Intent to Treat Population (Modified)||Units on a scale||Standard Deviation|Mean
745192|NCT00514852|Secondary|Patient Acceptability Score (Vision) at Day 30|Vision Quality Visual Analog Scale is measured on a 0-100 point scale (0 = very poor, has never been worse, 100 = excellent, has never been better).|Day 30|Intent to treat population||Units on a scale||Standard Deviation|Mean
745193|NCT00514852|Secondary|Patient Acceptability Score (Dryness) at Day 30|Dryness Severity Visual Analog Scale is measured on a 0-100 point scale (0 = could not be worse, 100 = none at all).|Day 30|Intent to Treat Population||Units on scale||Standard Deviation|Mean
745194|NCT00514852|Secondary|Change From Baseline at Day 30 in Tear Break-Up Time, With Fluorescein|Measures the stability of tear film. The average of 3 measures.|Change from baseline at Day 30|Intent to Treat Population||seconds||Standard Deviation|Mean
745195|NCT00514852|Secondary|Change From Baseline at Day 30 in Schirmer Test, With Anesthesia|Schirmer Test measures the rate of the secretion of tears|Change from baseline at Day 30|Intent to Treat Population||mm/5min||Standard Deviation|Mean
745196|NCT00514852|Primary|Change From Baseline at Day 30 in Ocular Surface Disease Index© Questionnaire Score|Ocular Surface Disease Index© Questionnaire Score is measured on 12 domains; a 5-point scale (0-4) for each domain. Sum of the domain scores is normalized to a severity scale of 0-100 (0 = no symptoms, 100 = maximum severity)|Change from baseline at Day 30|Intent to Treat Population (Modified)||Units on a scale||Standard Deviation|Mean
745210|NCT00514904|Primary|Number of Subjects With Grade 3 General Symptoms (Solicited and Unsolicited)|Grade 3 symptom was defined as symptom that prevented normal, everyday activities.|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Participants|||Count of Participants
745198|NCT00514904|Secondary|Number of Subjects Reporting Any Unsolicited Symptoms|Up to one month (Day 0-Day 30) after vaccination|Unsolicited symptom covers any symptom reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Participants|||Count of Participants
745199|NCT00514904|Secondary|Number of Subjects Reporting Specific Adverse Events (AEs)|Specific AEs include: rash; new onset of chronic illness(es) (NOCI) and/ or conditions prompting emergency room (ER) visits or non-routine physician office visits.|From Day 0 up to 6 months after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Participants|||Count of Participants
745200|NCT00514904|Secondary|Number of Subjects ≥ 6 Years of Age With Solicited General Symptoms|Solicited general symptoms assessed were fatigue, fever (measured orally and temperature ≥ 37.5°C ), gastrointestinal and headache. Any was defined as incidence of any general symptom regardless of intensity grade or relationship to vaccination.|During the 4-day (Days 0-3) follow-up period after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and with the symptom sheet filled-in.||Participants|||Count of Participants
745201|NCT00514904|Secondary|Number of Subjects < 6 Years of Age With Solicited General Symptoms|Solicited general symptoms assessed were drowsiness, fever (measured orally and temperature ≥ 37.5°C ), irritability and loss of appetite. Any was defined as incidence of any general symptom regardless of intensity grade or relationship to vaccination.|During the 4-day (Days 0-3) follow-up period after vaccination|The analysis was performed on the Total Vaccinated cohort (TVC), which included all vaccinated subjects for whom data were available and with the symptom sheet filled-in.||Participants|||Count of Participants
745202|NCT00514904|Secondary|Number of Subjects ≥ 6 Years of Age With Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any local symptom regardless of intensity grade.|During the 4-day (Days 0-3) follow-up period after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and with the symptom sheet filled-in.||Participants|||Count of Participants
745203|NCT00514904|Secondary|Number of Subjects Less Than (<) 6 Years of Age With Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any local symptom regardless of intensity grade.|During the 4-day (Days 0-3) follow-up period after vaccination|The analysis was performed on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects for whom data were available and with the symptom sheet filled-in.||Participants|||Count of Participants
745204|NCT00514904|Secondary|Anti-polysaccharide (Anti-PS) Antibody Concentrations|Anti-PS concentrations were expressed as geometric mean concentrations (GMCs) and expressed in μg/mL. One half of the subjects (50%, randomized) of the ATP cohort for immunogenicity was tested for anti-PSA and anti-PSC and the other half for anti-PSW-135 and anti-PSY.|Pre vaccination (Month 0) and post vaccination (Month 1)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component from the blood sample taken one month after vaccination.||μg/mL||95% Confidence Interval|Geometric Mean
745205|NCT00514904|Secondary|Number of Subjects With Anti-polysaccharide (Anti-PS) Concentrations Greater Than or Equal to (≥) the Cut-off Values|The cut-off values for anti-PS concentrations were ≥ 0.3 microgram per milliliter (μg/mL) and ≥ 2.0 μg/mL respectively for the anti- PSA, anti-PSC, anti-PSW-135 and anti-PSY antibodies respectively. One half of the subjects (50%, randomized) of the ATP cohort for immunogenicity was tested for anti-PSA and anti-PSC and the other half for anti-PSW-135 and anti-PSY.|Pre vaccination (Month 0) and post vaccination, (Month 1)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component from the blood sample taken one month after vaccination.||Participants|||Count of Participants
745206|NCT00514904|Secondary|Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations|Antibody concentrations were expressed as geometric mean concentrations (GMCs)|Pre vaccination (Month 0) and post vaccination (Month 1)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component from the blood sample taken one month after vaccination.||Titer||95% Confidence Interval|Geometric Mean
745207|NCT00514904|Secondary|Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Concentrations Greater Than or Equal to (≥) the Cut-off Values|The cut-off values for anti-TT concentrations were ≥ 0.1 international units per milliliter (IU/mL) and ≥ 1.0 IU/mL respectively.|Pre vaccination (Month 0) and post vaccination (Month 1)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component from the blood sample taken one month after vaccination.||Participants|||Count of Participants
745208|NCT00514904|Secondary|rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers|Antibody titers were expressed as geometric mean titers (GMTs).|Pre vaccination (Month 0) and post vaccination (Month 1)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component from the blood sample taken one month after vaccination.||Titer||95% Confidence Interval|Geometric Mean
745209|NCT00514904|Secondary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Titers Greater Than or Equal (≥) to the Cut-off Values|The cut-off values for the rSBA titers were ≥ 1:8 and ≥ 1:128 respectively.|Pre vaccination (Month 0) and post vaccination (Month 1)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component from the blood sample taken one month after vaccination.||Participants|||Count of Participants
745211|NCT00514904|Primary|Number of Subjects With Vaccine Response to N. Meningitidis Serogroups A (MenA), MenC, MenY and MenW-135|Vaccine response was defined as an rSBA titer of at least 1:32 in subjects initially seronegative (< 1:8) and as 4-fold increase in titer from pre- to post-vaccination in subjects initially seropositive (≥ 1:8).|One month after vaccination (Post-vaccination, study Month 1)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component from the blood sample taken one month after vaccination.||Participants|||Count of Participants
745212|NCT00514917|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|TEAE: any adverse event (AE) that occurred or worsened during the on-treatment period, which was the period from first administration of study treatment until 30 days after last administration of study treatment. AE: any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious AE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly, or medically important. Drug-related AEs were any untoward medical occurrences attributed to study drug in a participant who received study drug. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 Grade 3 (severe) and Grade 4 (life threatening/disabling) TEAEs were also reported.|From first administration of study treatment until 30 days after the last administration of study treatment|Safety population included all randomized participants who received at least part of one dose of any of the study drugs.||participants|||Number
745213|NCT00514917|Secondary|Change From Baseline in Erectile Function Domain of International Index of Erectile Function (EF-IIEF) Total Score at EOT|EF-IIEF is a 6-item erectile function domain of IIEF. It consists of Question 1, 2, 3, 4, 5, and 15 of IIEF questionnaire. 5 questions are scored from 0 (no activity) to 5 (very high activity) and 1 question is scored from 1 (very low activity) to 5 (very high activity). Total EF-IIEF score ranges from 1 to 30, where higher score indicates high activity.|Baseline, EOT (up to Month 18)|"ITT population. Here N (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants evaluable at each time-point for each treatment arm, respectively."||units on a scale||Standard Deviation|Mean
745214|NCT00514917|Primary|Progression-Free Survival (PFS) Rate at Month 36 in Testosterone Specific Evaluable Population|PFS rate at Month 36 was defined as probability of being progression-free at Month 36. PFS rate was estimated using the Kaplan-Meier method.|Month 36|Testosterone-specific evaluable population included all participants who recovered testosterone to non-castrate levels (50 ng/mL) following completion of treatment of leuprolide with at least 1 follow-up PSA assessment.||percent chance of being progression-free||95% Confidence Interval|Number
745215|NCT00514917|Secondary|Change From Baseline in Multidimensional Assessment of Fatigue (MAF) Index Score at EOT|MAF scale consists of 16-items to measure 4 dimensions of fatigue during past week: severity (Item 1-2), distress (Item 3), degree of interference in activities of daily living (Item 4-14), and timing (Item 15-16). Item 1-14 are scored on a numeric rating scale from 1 to 10, where higher score indicate more severity/distress/interference. Item 15-16 had multiple choice responses (4 responses each). Scale Index was calculated using Item 1-15, in following steps: 1) Item 15 score converted to 1-10 scale by multiplying the score with 2.5; 2) Average score was calculated from Item 4-14; 3) Finally scale index was calculated by adding Items 1, 2, 3 scores with average score from step 2 and converted score of Item 15 from step 1. Total MAF scale index score ranges 1 (no fatigue) to 50 (severe fatigue).|Baseline, EOT (up to Month 18)|ITT population. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants evaluable at each time-point for each treatment arm, respectively.||units on a scale||Standard Deviation|Mean
745216|NCT00514917|Primary|Median Progression-Free Survival (PFS) in Testosterone Specific Evaluable Population|PFS was the time from randomization to the date of first documented PSA progression, or radiographic progression, or death due to prostate cancer in the absence of previous documentation of disease progression, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method.|Randomization until PSA progression or radiographic progression or death due to prostate cancer, assessed up to Month 60|Testosterone-specific evaluable population included all participants who recovered testosterone to non-castrate levels (50 ng/mL) following the completion of treatment of leuprolide with at least 1 follow-up PSA assessment.||months||95% Confidence Interval|Median
745217|NCT00514917|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Trial Outcome Index (TOI) Score at EOT|Physical well-being, functional well-being, and prostate cancer concerns sub-scales of the FACT-P questionnaire were combined to calculate TOI. Total TOI score ranges from 0 to 104, with higher scores representing a better quality of life with fewer symptoms.|Baseline, EOT (up to Month 18)|ITT population. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants evaluable at each time-point for each treatment arm, respectively.||units on a scale||Standard Deviation|Mean
745218|NCT00514917|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Total Score at End of Treatment (EOT)|FACT-P is a 39-item participant questionnaire which assesses physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and additional prostate cancer specific concerns (12 items). All items are scored from 0 (not at all) to 4 (very much). The total FACT-P score ranges from 0-156, with higher scores representing a better quality of life with fewer symptoms. A score of 156 represents the best outcome.|Baseline, EOT (up to Month 18)|ITT population. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants evaluable at each time-point for each treatment arm, respectively.||units on a scale||Standard Deviation|Mean
745219|NCT00514917|Secondary|Cancer-Specific Survival: Number of Participants Who Died (Cancer-Specific)|The cancer-specific survival was the time from the date of randomization to the date of death due to prostate cancer. Cancer-specific survival was to be analyzed using the Kaplan-Meier method. However, the analysis was not performed due to insufficient number of events. Reported is the number of participants who died from prostate cancer.|Randomization until death due to prostate cancer, assessed up to Month 60|ITT population.||participants|||Number
745220|NCT00514917|Secondary|Overall Survival (OS): Number of Participants Who Died (All Cause)|The OS was the time interval from the date of randomization to the date of death due to any cause. OS was to be analyzed using the Kaplan-Meier method. However, the analysis was not performed due to insufficient number of events. Reported is the number of participants who died from any cause.|Randomization until death due to any cause, assessed up to Month 60|ITT population.||participants|||Number
745221|NCT00514917|Primary|Progression-Free Survival (PFS) Rate at Month 36 in ITT Population|PFS rate at Month 36 was defined as probability of being progression-free at Month 36. PFS rate was estimated using the Kaplan-Meier method.|Month 36|ITT population.||percent chance of being progression-free||95% Confidence Interval|Number
745222|NCT00514917|Primary|Median Progression-Free Survival (PFS) in Intent-to-treat (ITT) Population|PFS was the time from randomization to the date of first documented prostate specific antigen (PSA) progression, or radiographic progression, or death due to prostate cancer in the absence of previous documentation of disease progression, whichever occurred first. PSA progression was determined as: a) During treatment period: a 50 percent (%) increase from baseline, which was confirmed by a second value; b) During follow-up: detectable PSA (defined as PSA greater than or equal to 0.05 nanogram per millimeter [ng/mL]), which was confirmed by consecutive observation (not less than 2 weeks apart). Median PFS was estimated using the Kaplan-Meier method.|Randomization until PSA progression or radiographic progression or death due to prostate cancer, assessed up to Month 60|ITT population included all participants who were randomized, with study drug assignment designated according to randomization, regardless of whether participants received any study drug or a different drug from that to which they were randomized.||months||95% Confidence Interval|Median
745223|NCT00514943|Secondary|Pre-dose Concentration of Afatinib in Plasma for Dose 40mg and 50mg at Steady State on Day 57 (Cpre,ss, 57)|Cpre,ss,57 represents the pre-dose concentration of afatinib in plasma at steady state on day 57.|Day 57|Pharmacokinetic Set (PK)||ng/mL||Geometric Coefficient of Variation|Geometric Mean
745224|NCT00514943|Secondary|Pre-dose Concentration of Afatinib in Plasma for Dose 40mg and 50mg at Steady State on Day 29 (Cpre,ss,29)|"Cpre,ss,29 represents the pre-dose concentration of afatinib in plasma at steady state on day 29.
Note: At day 29, values for afatinib 40 mg no values reported in stage 2."|Day 29|Pharmacokinetic Set (PK)||ng/mL||Geometric Coefficient of Variation|Geometric Mean
745225|NCT00514943|Secondary|Pre-dose Concentration of Afatinib in Plasma for Dose 40mg and 50mg at Steady State on Day 15 (Cpre,ss,15)|"Cpre,ss,15 represents the pre-dose concentration of afatinib in plasma at steady state on day 15.
Note: At day 15, values for afatinib 40 mg no values reported in stage 1 and stage 2."|Day 15|Pharmacokinetic Set (PK): The PK analysis was based on all patients who were treated with afatinib and who had evaluable plasma concentration data, which consisted of data for 60 patients in Stage 1 and 35 patients in Stage 2.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
745226|NCT00514943|Secondary|Incidence and Intensity of Adverse Events With Grading According CTCAE|Incidence and intensity of Adverse Events with grading according to the Common Terminology Criteria for Adverse Events (CTCAE version 3.0).|First administration of trial medication until 28 days after last drug administration|Treated Set in Stage 1 : This analysis set included the randomized patients who took at least 1 dose of the randomized treatment (61 afatinib and 60 cetuximab patients. Treated set in Stage 2: This analysis set included all patients who received treatment: 36 patients in the afatinib and 32 patients in the cetuximab arm.||percentage of participants|||Number
745227|NCT00514943|Secondary|Patients With AEs Resulting in Diarrhea, Skin Rash, Dose Reduction, Treatment Discontinuation and Decreased Cardiac Left Ventricular Function|"Patients with adverse events (AEs) resulting in Diarrhea, Skin Rash, dose reduction, treatment discontinuation and decreased cardiac left ventricular function
Note: To asses the Decreased Cardiac left ventricular function, Left ventricular ejection fraction (LVEF) was assessed in patients treated with afatinib in Stage 1 and Stage 2 . And no patients in either group had a significant change in LVEF during Stage 1 or Stage 2 of the trial."|First administration of trial medication until 28 days after last drug administration|Treated Set in Stage 1 : This analysis set included the randomized patients who took at least 1 dose of the randomized treatment (61 afatinib and 60 cetuximab patients. Treated set in Stage 2: This analysis set included all patients who received treatment: 36 patients in the afatinib and 32 patients in the cetuximab arm.||number of participants|||Number
745228|NCT00514943|Secondary|Time to Deterioration in HRQoL - Stage 1|"Health related Quality of Life (HRQoL) for Time to deterioration was assessed using the the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the Head and Neck Cancer Module (H&N35).
Time to deterioration in HRQoL (defined as a 10-point change towards worsening from the baseline score on a 0-100 point scale) was determined for:
global health status (Questions 29 and 30 in EORTC QLQ C30)
pain (Questions 9 and 19 in EORTC QLQ C30)
swallowing (Questions 35 to 38 in EORTC QLQ-H&N35)"|From randomisation to deterioration in HRQoL scores before crossover.|Randomised Set (RS)||months||95% Confidence Interval|Median
745229|NCT00514943|Secondary|Overall Survival (OS)|"OS is defined as time from randomisation to death.
Median is calculated from the Kaplan−Meier curve for each treatment group."|From randomisation to data cut-off date.|Randomised set (RS).||Weeks||95% Confidence Interval|Median
745230|NCT00514943|Secondary|Progression Free Survival (PFS) After Crossover Based on Investigator Assessment|"PFS is defined as time from first administration study medication after cross over until the occurrence of tumor progression or death, whichever came first, during Stage 2 of the trial.
Median is calculated from the Kaplan−Meier curve for each treatment group."|From first administration of study medication after cross over to disease progression in Stage 2 or death whichever came first after crossover.|Patients treated in stage 2||weeks||95% Confidence Interval|Median
745231|NCT00514943|Secondary|Progression Free Survival (PFS) Before Crossover Based on Investigator Assessment|"PFS is defined as time from randomisation to until the occurrence of tumor progression or death, whichever occurred first, during Stage 1 of the trial.
Median is calculated from the Kaplan−Meier curve for each treatment group."|From randomisation to disease progression in Stage 1 or death whichever occurred first before crossover.|Randomised set (RS).||weeks||95% Confidence Interval|Median
745232|NCT00514943|Secondary|Best RECIST Assessment as Confirmed Duration of Disease Control as Per ICR for Stage 2|Best RECIST Assessment as confirmed duration of disease control as per the independent central review (ICR) assessment according to the RECIST 1.0 criteria.|Response determined during Stage 2 or within 28 days after termination of Stage 2 treatment|patients treated in stage 2||Weeks||Standard Deviation|Mean
745233|NCT00514943|Secondary|Best RECIST Assessment as Confirmed Duration of Objective Response and Disease Control as Per Investigator Assessment for Stage 2|Best RECIST Assessment as confirmed duration of objective response and disease control as per Investigator assessment according to the RECIST 1.0 criteria.|Response determined during Stage 2 or within 28 days after termination of Stage 2 treatment|patients treated in stage 2||Weeks||Standard Deviation|Mean
745234|NCT00514943|Secondary|Best RECIST Assessment as Confirmed Duration of Confirmed Objective Response and Disease Control as Per ICR for Stage 1|Best RECIST Assessment as duration of confirmed objective response and disease control as per the independent central review (ICR) according to the RECIST 1.0 criteria.|Response determined from randomization until patient started Stage 2 or within 28 days after termination of Stage 1 treatment|Randomised Set (RS)||Weeks||Standard Deviation|Mean
745235|NCT00514943|Secondary|Best RECIST Assessment as Confirmed Duration of Objective Response and Disease Control as Per Investigator Assessment for Stage 1|Best RECIST Assessment as duration of confirmed objective response and disease control as per Investigator assessment according to the RECIST 1.0 criteria.|Response determined from randomization until patient started Stage 2 or within 28 days after termination of Stage 1 treatment|Randomised Set (RS)||Weeks||Standard Deviation|Mean
745236|NCT00514943|Secondary|Best RECIST Assessment as Onset of Confirmed Objective Response as Per Investigator Assessment for Stage 2|Best RECIST Assessment as onset of confirmed objective response as per Investigator assessment according to the RECIST 1.0 criteria.|Response determined during Stage 2 or within 28 days after termination of Stage 2 treatment|Patients treated in Stage 2||Number of participants|||Number
745237|NCT00514943|Secondary|Best RECIST Assessment as Onset of Confirmed Objective Response as as Per ICR for Stage 1|Best RECIST Assessment as onset of confirmed objective response as per the independent central review (ICR) according to the RECIST 1.0 criteria.|Response determined from randomization until patient started Stage 2 or within 28 days after termination of Stage 1 treatment|Randomised set (RS).||Number of participants|||Number
745238|NCT00514943|Secondary|Best RECIST Assessment as Onset of Confirmed Objective Response as Per Investigator Assessment for Stage 1|Best RECIST Assessment as onset of confirmed objective response as per Investigator assessment for Stage 1.|Response determined from randomization until patient started Stage 2 or within 28 days after termination of Stage 1 treatment|Randomised set (RS).||Number of participants|||Number
745239|NCT00514943|Secondary|Best RECIST Assessment as Per ICR for Stage2 (as Confirmed Disease Control (Clinical Benefit) and Objective Response Are Simply Categories of RECIST Assessment)|Best RECIST Assessment is defined as confirmed Disease control (complete response (CR), partial response (PR) and Stable disease (SD)), Best objective response ( complete response (CR) or partial response (PR)) as assessed by the independent central review (ICR) according to the RECIST 1.0 criteria.|Response determined during Stage 2 or within 28 days after termination of Stage 2 treatment|Patients treated in Stage 2||Number of participants|||Number
745240|NCT00514943|Secondary|Best RECIST Assessment as Per Investigator Assessment for Stage 2 (as as Confirmed Disease Control (Clinical Benefit) and Objective Response Are Simply Categories of RECIST Assessment)|Best RECIST Assessment is defined as confirmed Disease control (complete response (CR), partial response (PR) and Stable disease (SD)), Objective response ( complete response (CR) or partial response (PR)) assessed by the investigator according to the RECIST 1.0 criteria.|Response determined during Stage 2 or within 28 days after termination of Stage 2 treatment|Patients treated in Stage 2||Number of participants|||Number
745241|NCT00514943|Secondary|Best RECIST Assessment as Per ICR for Stage 1 (as Confirmed Disease Control (Clinical Benefit) and Objective Response Are Simply Categories of RECIST Assessment).|Best RECIST Assessment is defined as confirmed Disease control (complete response (CR), partial response (PR) and Stable disease (SD)), Best objective response ( complete response (CR) or partial response (PR)) as assessed by the independent central review (ICR) according to the RECIST 1.0 criteria.|Response determined from randomization until patient started Stage 2 or within 28 days after termination of Stage 1 treatment|Randomised set (RS).||Number of participants|||Number
745242|NCT00514943|Secondary|Best RECIST Assessment as Per Investigator Assessment for Stage 1 (as Confirmed Disease Control (Clinical Benefit) and Objective Response Are Simply Categories of RECIST Assessment).|Best RECIST Assessment is defined as confirmed Disease control (complete response (CR), partial response (PR) and Stable disease (SD)), Objective response ( complete response (CR) or partial response (PR)) assessed by the investigator according to the RECIST 1.0 criteria.|Response determined from randomization until patient started Stage 2 or within 28 days after termination of Stage 1 treatment|Randomised set (RS).||Number of participants|||Number
745243|NCT00514943|Secondary|Tumor Shrinkage After Crossover (Stage 2) as Per Investigator Assessments|Tumor shrinkage after crossover was defined as the change from baseline in the smallest post-crossover sum of the longest diameters of target lesions (SLD), calculated as the smallest SLD after crossover minus SLD at baseline. Baseline was the SLD measured at the time of crossover, or the closest measurement before the patient started stage 2 treatment. A negative value means the smallest post-crossover SLD was smaller than baseline (decreased after crossover), a positive value means tumor size increased after crossover.|From baseline assessed prior to first dose of Stage 2 study medication to 28 days after termination of Stage 2 treatment.|Patients treated in stage 2 : This analysis set included all patients who received treatment: 36 patients in the afatinib and 32 patients in the cetuximab arm.||millimeters||Standard Deviation|Mean
745244|NCT00514943|Primary|Tumor Shrinkage Before Crossover (Stage 1) of the Trial as Per Investigator Assessment|"Tumor shrinkage before crossover was defined as the change from baseline in the smallest post-randomisation sum of the longest diameters of target lesions (SLD), calculated as the smallest SLD after randomisation but before crossover minus SLD at baseline. Baseline was the SLD measured before randomisation. A negative value means the smallest post-randomisation SLD was smaller than baseline (decreased since baseline); a positive value means tumor size increased since baseline.
Mean calculated is actually the Adjusted mean. Adjusted mean is obtained from fitting an ANCOVA model including treatment, stratification factor prior chemotherapy for recurrent/metastatic disease and the baseline sum of longest distance of target lesions as covariates."|From randomization until start of Stage 2 treatment, or within 28 days after the termination of Stage 1.|Randomised Set (RS). The randomised set includes all patients who were randomised to receive treatment, whether treated or not. However, patients without baseline or post-baseline tumor measurements were excluded.||millimeter||Standard Error|Mean
745246|NCT00515008|Secondary|Mean Change From Baseline CES-D Score|The Center for Epidemiologic Studies (CES-D) Depression Scale (range, 0 to 60, with higher scores indicating more severe depression), is a self-report measure of depressive symptoms.|12 weeks|||units on a scale||95% Confidence Interval|Mean
745247|NCT00515008|Secondary|Mean Change From Baseline SF-36 Score Mental Component|The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) Mental Component is the summary score for the mental quality-of-life components (range, 0 to 100, with higher scores indicating better health status)|12 weeks|||units on a scale||95% Confidence Interval|Mean
745248|NCT00515008|Secondary|Mean Change From Baseline SF-36 Score Physical Component|The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) Physical Component is the summary score for the physical quality-of-life components (range, 0 to 100, with higher scores indicating better health status)|12 weeks|||units on a scale||95% Confidence Interval|Mean
745249|NCT00515008|Secondary|Mean Change From Baseline of 6-Minute Walk Test||12 weeks|||yards||95% Confidence Interval|Mean
745250|NCT00515008|Secondary|Mean Change From Baseline PSQI Score|The Pittsburgh Sleep Quality Index (PSQI) is a self-report measure of sleep quality(range, 0 to 21, with higher scores indicating worse sleep quality)|12 weeks|||units on a scale||95% Confidence Interval|Mean
745251|NCT00515008|Secondary|Mean Change From Baseline of Patient’s Global Assessment Score|Patients' global assessment score was assessed separately by the participant, who was unaware of the group assignment, with the use of a visual-analogue scale (VAS) (range, 0 to 10,with higher scores indicating greater pain).|12 weeks|||units on a scale||95% Confidence Interval|Mean
745252|NCT00515008|Secondary|Mean Change From Baseline of VAS Physicians' Global Assessment of Fibromyalgia Severity|Physicians' global assessment score was assessed separately by the study physician, who was unaware of the group assignment, with the use of a visual-analogue scale (VAS) (range, 0 to 10,with higher scores indicating greater pain).|Wks 12|||units on a scale||95% Confidence Interval|Mean
745253|NCT00515008|Primary|Mean Change From Baseline of Fibromyalgia Impact Questionnaire Score|Fibromyalgia Impact Questionnaire (FIQ) is a well-validated, multidimensional measure of the overall severity of fibromyalgia as rated by patients. Categories include the intensity of pain, physical functioning, fatigue, morning tiredness, stiffness, depression, anxiety, job difficulty, and overall well-being.21 The total score ranges from 0 to 100, with higher scores indicating more severe symptoms.|wks 12|||units on a scale||95% Confidence Interval|Mean
745254|NCT00515034|Secondary|Patients With cIAI Who Were Clinically Cured|clinical cure is the complete resolution or significant improvement of signs or symptoms of cIAI, such that no additional antimicrobial therapy or surgical or percutaneous intervention is required for the treatment of the current infection.|7 to 14 days after the end of IV therapy|participants who were clinically evaluable||participants|||Number
745255|NCT00515034|Secondary|Patients With VAP Who Were Clinically Cured|clinical cure is the complete resolution of signs and symptoms of pneumonia or lack of progression of chest x-ray abnormalities to such an extent that no further antimicrobial therapy was necessary.|7 to 14 days after the end of IV therapy|the population is the number of participants who are clinically evaluable||participants|||Number
745256|NCT00515034|Primary|Patients With Incidence of Treatment-emergent Adverse Events (TEAEs).|Treatment-emergent adverse events (TEAEs) are defined as AEs with onset dates on or after the date of the start of the infusion of first dose of study therapy and within 30 days after administration of the last dose of study therapy.|from the initiation of the first infusion of study drug therapy and up to 30 days after the completion of study drug therapy|population is the as-treated analysis set - that is subjects who were administered therapy||participants|||Number
745257|NCT00515073|Primary|Overall Survival at 2 Years and 5 Years|The percentage of participants who are still alive for A designated period of time (2 years and 5 years) after starting treatment. Continual Assessments every 3 months for 1 year, then every 4 months for 2 years, then every 6 months for 2 years, then once a year.|Assessment at 2 years and 5 years|Two participants were inevaluable.||percentage of participants|||Number
745258|NCT00515086|Secondary|Surgery Group: Number of Participants With Adverse Events|The number of participants with any adverse event by System Organ Class. Additional information about Adverse Events can be found in the Adverse Event Section.|First day of treatment to study discontinuation (Up to 28 weeks)|Surgery Group participants from the Safety population who received at least one dose of study medication.||Participants|||Number
745259|NCT00515086|Secondary|No Surgery Group: Progression Free Survival|Progression-free survival (PFS) was assessed using Gadolinium chelate-enhanced Magnetic Resonance Imaging (MRI) and based on the Neuro-Oncology Criteria for Tumor Response for CNS tumors. PFS is reported for participants with 1 previous relapse and participants with ≥2 previous relapses. PFS was measured from the first day of treatment to disease progression or death and is derived using the Kaplan-Meier method.|First day of treatment to study discontinuation (up to 60 weeks)|No Surgery Group participants from the Intent-to-treat (ITT) population who received at least one dose of study medication.||Weeks||95% Confidence Interval|Median
745260|NCT00515086|Secondary|Surgery Group: Biomarkers Phosphatase and Tensin Homolog (PTEN) and Epidermal Growth Factor Receptor (EGFR)|"The secondary efficacy assessment was to evaluate the role of PTEN and EGFR pathway status on phosphor-S6. Tumor cells from the initial surgical resection and from the salvage resection were used for assessments. Immunohistochemistry and Fluorescence in-situ hybridization (FISH) were used to assess PTEN and EGFR pathway status.
Study was terminated due to slow enrollment. Analysis was not possible due to insufficient sample size."|After surgery, week 4, week 8 and every 8 weeks thereafter|Study was terminated due to slow enrollment.||Levels||Standard Deviation|Mean
745261|NCT00515086|Secondary|Surgery Group: Progression-free Survival|Progression-free survival (PFS) was assessed using Gadolinium chelate-enhanced Magnetic Resonance Imaging (MRI) and based on the Neuro-Oncology Criteria for Tumor Response for CNS tumors. PFS was measured from the first day of treatment after surgery to disease progression or death and is derived using the Kaplan-Meier method.|After surgery (within 96 hours), Weeks 4 and 8 and then every 8 weeks after restarting treatment until study discontinuation (Up to 28 weeks)|Results for the Surgery Group only include patients with residual tumor following salvage surgery.||Weeks||95% Confidence Interval|Median
745262|NCT00515086|Secondary|Surgery Group: Blood and Brain Tissue Levels of Everolimus (RAD001)||Baseline and Day 7-9 (Blood samples were collected one day prior to surgery and tissue samples were collected during surgery.)|Study was terminated due to slow enrollment.||Levels||Standard Deviation|Mean
745263|NCT00515086|Primary|No Surgery Group: Best Overall Tumor Response|The best overall tumor response is reported for participants with 1 previous relapse and participants with ≥2 previous relapses according to the following categories: Complete Response, Partial Response, Stable Disease and Progressive Disease. Gadolinium chelate-enhanced Magnetic Resonance Imaging (MRI) was used for tumor analysis. The objective assessment of tumor response was evaluated at each site by the designated pathologist based on the Neuro-Oncology criteria for Tumor Response for Central Nervous System (CNS) tumors.|First day of treatment to study discontinuation (up to 60 weeks)|No Surgery Group participants from the Intent-to-treat (ITT) population who received at least one dose of study medication.||Participants|||Number
745264|NCT00515086|Primary|Surgery Group: Percentage Change From the Baseline in S6 Kinase Levels|In the Surgery Group, the primary efficacy assessment was inhibition of Mammalian target of rapamycin (mTOR) as defined as ≥75% S6 phosphorylation. The occurrence of S6 phosphorylation was determined by phosphor-S6 immunohistochemical staining. Tumor cells from the initial surgical resection and from the salvage resection were used for assessments.|Baseline and Day 7-9 (during salvage surgery)|Study was terminated due to slow enrollment.||Percentage change in S6 kinase|||Number
745265|NCT00515099|Secondary|Hemoglobin A1c|Glycosylated hemoglobin (HbA1c) is a measure of the average plasma concentration of blood sugar (glucose) over the previous three months and measures the level of optimal management of underlying disease. An HbA1c of <\=5.6% is considered normal. HbA1c of 6.5% or higher is typical for individuals with Type 1 Diabetes mellitus (T1DM).|Baseline (Pre-treatment), Months 12 and 24|Intent-to-treat||Percentage (%)||Standard Deviation|Mean
745266|NCT00515099|Secondary|2-Hour and 4-Hour C-peptide Area Under the Curve (AUC) Results in Response to Standardized Mixed Meal Tolerance Test (MMTT)|C-peptide is a substance released by the pancreas into the bloodstream in equal amounts to insulin and reflects how much insulin pancreatic beta cells are making. The standardized MMTT evaluates whether beta cells are producing endogenous insulin. The MMTT was performed in the morning and blood samples for C-peptide collected at baseline (pre-meal) and 15, 30, 60, 90, 120, 150, 180, 210,and 240 minutes post-meal. Results of the stimulated 2-hour (e.g., 120 minutes) and 4-hour (e.g., 240 minutes) post-meal C-peptide AUC are provided. Larger numbers are preferable (better) in these AUC results: more insulin being produced reflects less severe disease. C-peptide levels in the serum (e.g., AUC following a standardized MMTT) compared to control group at 1 year post treatment initiation for the evaluation of investigational products intended to preserve endogenous beta-cell function in T1DM trials is recognized by the CDER at the FDA as a valid efficacy endpoint.|Baseline (Pre-treatment), Month 24|Intent-to-treat||pmol/mL||Standard Deviation|Mean
745267|NCT00515099|Secondary|Number of Participants With Major Hypoglycemic Event(s) Post Treatment Randomization/Initiation|Major hypoglycemic events are defined as a glucose concentration <55 mg/dL (grades 2-5, NCI-CTCAE version 3.0), or clinically: involving seizure(s) or involving loss of consciousness (coma), or requiring assistance from another individual in order to recover.|Baseline (Pre-treatment), Months 12 , and 24|Intent-to-treat||participants|||Number
745268|NCT00515099|Secondary|Number of Participants Who Are Exogenous-Insulin-Free|The need to use exogenous insulin is an indication that the body is not producing enough endogenous insulin. Higher amounts of insulin use indicate higher disease activity.|Baseline (Pre-treatment), Months 12 , 18, and 24|Intent-to-treat||participants|||Number
745269|NCT00515099|Secondary|Insulin Use in Units Per Kilogram Body Weight Per Day|The need to use exogenous insulin is an indication that the body is not producing enough endogenous insulin. Higher amounts of insulin use indicate higher disease activity.|Baseline (Pre-treatment), Months 12 and 24|Intent-to-treat||units/day/kg||Standard Deviation|Mean
745270|NCT00515099|Secondary|4-Hour C-peptide Area Under the Curve (AUC) Result in Response to Standardized Mixed Meal Tolerance Test (MMTT)|C-peptide is a substance released by the pancreas into the bloodstream in equal amounts to insulin and reflects how much insulin pancreatic beta cells are making. The standardized MMTT evaluates whether beta cells are producing endogenous insulin. The MMTT was performed in the morning and blood samples for C-peptide collected at baseline (pre-meal) and 15, 30, 60, 90, 120, 150, 180, 210,and 240 minutes post-meal. Results of the stimulated 4-hour (e.g., 240 minutes) post-meal C-peptide AUC are provided. Larger numbers are preferable (better) in these AUC results: more insulin being produced reflects less severe disease. C-peptide levels in the serum (e.g., AUC following a standardized MMTT) compared to control group at 1 year post treatment initiation for the evaluation of investigational products intended to preserve endogenous beta-cell function in T1DM trials is recognized by the Center for Drug Evaluation and Research (CDER) at the FDA as a valid efficacy endpoint.|Baseline (Pre-treatment initiation), Month 12|Intent-to-treat||pmol/mL||Standard Deviation|Mean
745271|NCT00515099|Primary|2-Hour C-peptide Area Under the Curve (AUC) Result in Response to Standardized Mixed Meal Tolerance Test (MMTT)|C-peptide is a substance released by the pancreas into the bloodstream in equal amounts to insulin and reflects how much insulin pancreatic beta cells are making. The standardized MMTT evaluates whether beta cells are producing endogenous insulin. The MMTT was performed in the morning and blood samples for C-peptide collected at baseline (pre-meal) and 15, 30, 60, 90, 120, 150, 180, 210,and 240 minutes post-meal. Results of the stimulated 2-hour (e.g., 120 minutes) post-meal C-peptide AUC are provided. Larger numbers are preferable (better) in these AUC results: more insulin being produced reflects less severe disease. C-peptide levels in the serum (e.g., AUC following a standardized MMTT) compared to control group at 1 year post treatment initiation for the evaluation of investigational products intended to preserve endogenous beta-cell function in T1DM trials is recognized by the Center for Drug Evaluation and Research (CDER) at the FDA as a valid efficacy primary endpoint.|Baseline (Pre-treatment initiation), Month 12|Intent-to-treat||pmol/mL||Standard Deviation|Mean
745272|NCT00515112|Secondary|To Explore the Value of Androgen Receptor (AR) Expression in Circulating Tumor Cells.|The AR is defined as 4 categories by the observed data: no detectable cells, low AR expression, normal AR expression, and high AR expression.|every 8 weeks||||||
745291|NCT00515216|Secondary|Genetic Polymorphisms That May Alter Treatment Outcomes (Stable Disease)|This outcome looks at what genotypes of the TYMS 3'-UTR 1494delTTAAAG(6 bp) (rs34489327) gene had stable disease.|4 years|11 out of 25 participants had a partial response.||participants|||Number
745292|NCT00515216|Secondary|Genetic Polymorphisms That May Alter Treatment Outcomes (Stable Disease)|This outcome looks at what genotypes of the TYMS 5'-UTR TSER + G>C (rs34743033) gene had stable disease.|4 years|11 out of 25 participants had a partial response.||participants|||Number
780364|NCT00802880|Secondary|Rate of Nausea/Emesis (Any Grade)|Approximately 18 weeks|Completion of 6 cycles of treatment (18 weeks)|||percentage of participants|||Number
745273|NCT00515112|Primary|Progression Free Survival|Time to progression is measured from the date of randomization until the onset of the earliest of one of the following events: in the absence of a 50% decline in prostate-specific antigen (PSA), a PSA increase to 3 times the nadir PSA or an absolute PSA value of 50 ng/ml, whichever comes first; if at least a 50% decline in PSA is achieved from PSA peak value, a PSA increase of 50% above the nadir provided the increase is at least 5 ng/ml or back to baseline; one or more new skeletal lesions as shown on any bone scan or minimum of 1.5 cm in longest diameter on any computed tomography or magnetic resonance imaging scan; tumor flair; the occurrence of a clinical event, including death, determined by the investigator to represent disease progression.|Up to 5 years|This study has been terminated due to poor accrual.|||||
745274|NCT00515177|Secondary|Medical Outcome Study Short Form (SF-12)|Mental component summary score (MCS) of the SF-12 is a self-reported measure of mental health-related quality of life. Scores are reported as standardized T-scores, where an average (mean) score in the general population is 50 with a standard deviation of 10. Scores of 40 or less indicate impaired mental health quality or function.|8 weeks and 5 months|In the PCT arm, one person who refused to take the drug was excluded. 10-1=9 In the MBSR arm, one person who did not attend MBSR and one person who attended fewer than 5 classes were excluded. 20-2=18.||units on a scale||Standard Deviation|Mean
745275|NCT00515177|Secondary|Center for Epidemiological Studies Depression Scale (CES-D)|The CES-D is a 20-item self-report scale to measure symptoms of depression in the past week with scores having a range of 0 to 60 and a score of 16 or higher indicating clinically relevant symptoms.|8 weeks and 5 months|In the PCT arm, one person who refused to take the drug was excluded. 10-1=9 In the MBSR arm, one person who did not attend MBSR and one person who attended fewer than 5 classes were excluded. 20-2=18.||units on a scale||Standard Deviation|Mean
745276|NCT00515177|Secondary|State-Trait Anxiety Inventory (STAI)|The STAI is a 20 item scale that measures current anxiety symptoms with scores that range from 20 to 80, with higher scores indicating greater levels of anxiety. The norm for working adults is a score of 34.|8 weeks and 5 months|In the PCT arm, one person who refused to take the drug was excluded. 10-1=9 In the MBSR arm, one person who did not attend MBSR and one person who attended fewer than 5 classes were excluded. 20-2=18.||units on a scale||Standard Deviation|Mean
745277|NCT00515177|Primary|Actigraphy|Total Sleep Time from Actigraphy|8 weeks|In the PCT arm, one person who refused to take the drug and one who did not complete actigraphy were excluded. 10-2=8 In the MBSR arm, one person who did not attend MBSR, one person who attended fewer than 5 classes, and two who did not complete actigraphy were excluded. 20-4=16.||hours||Standard Deviation|Mean
745278|NCT00515177|Primary|Insomnia Severity Index|The Insomnia Severity Index is a 7-item scale that provides a total score indicating current (e.g., last 2 weeks) severity of insomnia symptoms with scores that can range from 0 to 28. Scores of 15 or higher indicate clinical insomnia.|8 weeks and 5 months|In the PCT arm, one person who refused to take the drug was excluded. 10-1=9 In the MBSR arm, one person who did not attend MBSR and one person who attended fewer than 5 classes were excluded. 20-2=18.||units on a scale||Standard Deviation|Mean
745279|NCT00515177|Primary|Pittsburgh Sleep Quality Index (PSQI)|The PSQI is a 19-item self-reported sleep quality measure with scores that range from 0 to 21, where higher scores indicate worse sleep quality. Scores greater than 5 indicate poor sleep.|8 weeks and 5 months|In the PCT arm, one person who refused to take the drug was excluded. 10-1=9 In the MBSR arm, one person who did not attend MBSR and one person who attended fewer than 5 classes were excluded. 20-2=18.||units on a scale||Standard Deviation|Mean
745280|NCT00515203|Primary|Adverse Events|Occurrence of one or more adverse events in the participant during the 12-week treatment period|12 weeks|Safety Analysis Set, composed of all participants who received at least one dose of study medication||Participants|||Number
745281|NCT00515203|Secondary|Requirement for Rescue Therapy (as Defined Per Protocol)|Participant required rescue therapy (as defined per protocol) during the 12 week treatment period.|12-week treatment period|Efficacy Analysis Set, composed of all randomized participants||Participants|||Number
745282|NCT00515203|Secondary|Increase in Platelet Count ≥ 20 x 10^9/L Above Baseline for Two Consecutive Weeks|Participant incidence of achieving an increase in platelet count ≥20 x 10^9/L above baseline for two consecutive weeks during the 12 week treatment period.|12-week treatment period|Efficacy Analysis Set, composed of all randomized participants||Participants|||Number
745283|NCT00515203|Secondary|Platelet Count ≥ 50 x 10^9/L for Two Consecutive Weeks|Participant incidence of achieving a platelet count ≥50 x 10^9/L for two consecutive weeks during the 12 week treatment period.|12-week treatment period|Efficacy Analysis Set, composed of all randomized participants||Participants|||Number
745284|NCT00515203|Secondary|Bleeding Events (Grade 2 or Higher)|Total number of bleeding events (Grade 2 or higher, i.e., mild to life-threatening, as defined in the protocol) for each participant during Weeks 2-13 (end-of-study visit for non-responders)|12-week treatment period (Weeks 2 - 13)|Efficacy Analysis Set, composed of all randomized participants||Events per participant||Standard Deviation|Mean
745285|NCT00515203|Secondary|Weeks With Platelet Count ≥ 50 x 10^9/L|The number of weeks with platelet count ≥ 50 x 10^9/L during the 12 week treatment period.|12-week treatment period|Efficacy Analysis Set, composed of all randomized participants||Weeks||Standard Deviation|Mean
745286|NCT00515216|Secondary|Genetic Polymorphisms That May Alter Treatment Outcomes (Stable Disease)|This outcome looks at what genotypes of the MDR1 c.3435C>T (rs1045642) gene had stable disease.|4 years|11 out of 25 participants had a partial response.||participants|||Number
745287|NCT00515216|Secondary|Genetic Polymorphisms That May Alter Treatment Outcomes (Stable Disease)|This outcome looks at what genotypes of the XRCC1 c.1196G>A (rs25487) gene had stable disease.|4 years|11 out of 25 participants had a partial response.||participants|||Number
745288|NCT00515216|Secondary|Genetic Polymorphisms That May Alter Treatment Outcomes (Stable Disease)|This outcome looks at what genotypes of the GSTP1 c.313A>G (rs1695) gene had stable disease.|4 years|11 out of 25 participants had a partial response.||participants|||Number
745289|NCT00515216|Secondary|Genetic Polymorphisms That May Alter Treatment Outcomes (Stable Disease)|This outcome looks at what genotypes of the ERCC2 c.2251A>C (rs13181) gene had stable disease.|4 years|11 out of 25 participants had a partial response.||participants|||Number
745290|NCT00515216|Secondary|Genetic Polymorphisms That May Alter Treatment Outcomes (Stable Disease)|This outcome looks at what genotypes of the ERCC1 c.354C>T (rs11615) gene had stable disease.|4 years|11 out of 25 participants had a partial response.||participants|||Number
745295|NCT00515216|Secondary|Genetic Polymorphisms That May Alter Treatment Outcomes (Partial Response)|This outcome looks at what genotypes of the GSTP1 c.313A>G (rs1695) gene had a partial response.|4 years|9 out of 25 participants had a partial response.||participants|||Number
745296|NCT00515216|Secondary|Genetic Polymorphisms That May Alter Treatment Outcomes (Partial Response)|This outcome looks at what genotypes of the ERCC2 c.2251A>C (rs13181) gene had a partial response.|4 years|9 out of 25 participants had a partial response.||participants|||Number
745297|NCT00515216|Secondary|Genetic Polymorphisms That May Alter Treatment Outcomes (Partial Response)|This outcome looks at what genotypes of the ERCC1 c.354C>T (rs11615) gene had a partial tumor response.|4 years|9 out of 25 participants had a partial response.||participants|||Number
745298|NCT00515216|Secondary|Genetic Polymorphisms That May Alter Treatment Outcomes (Partial Response)|This outcome looks at what genotypes of the TYMS 3'-UTR 1494delTTAAAG(6 bp) (rs34489327) gene had a partial tumor response.|4 years|9 out of 25 participants had a partial response.||participants|||Number
745299|NCT00515216|Secondary|Genetic Polymorphisms That May Alter Treatment Outcomes (Partial Response)|This outcome looks at what genotypes of the TYMS 5'-UTR TSER + G>C (rs34743033) gene had a partial tumor response.|4 years|9 out of 25 participants had a partial response.||participants|||Number
745300|NCT00515216|Secondary|Tumor Specific Changes That May Alter Treatment Outcomes||4 years|This was not completed as the archived tumor samples were not of sufficient quality for DNA extraction or analysis.|||||
745301|NCT00515216|Secondary|Disease Control Rate (DCR)|"DCR - complete response, partial response, and stable disease
Complete response - disappearance of all target and non-target lesions
Partial response - at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter
Stable disease - neither sufficient shrinkage to qualify for partial response not sufficient increase to qualify for progressive disease"|2 years|||percentage of participants||95% Confidence Interval|Number
745302|NCT00515216|Secondary|Progression-free Survival (PFS)|Progressive disease - at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions|4 years|||months||95% Confidence Interval|Median
745303|NCT00515216|Secondary|Overall Survival||4 years|||months||95% Confidence Interval|Median
745304|NCT00515216|Primary|Overall Response Rate (ORR)|"ORR = complete response + partial response
Complete response - disappearance of all target and non-target lesions
Partial response - at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter"|2 years|||percentage of participants||95% Confidence Interval|Number
745305|NCT00515294|Secondary|Psycho-motor Vigilance Test (PVT)|Participants completed 10 test trials to assess their psycho-motor response using a hand held box that randomly starts a scroll of numbers in milliseconds and as soon as it starts to scroll the participant needs to press a button to stop the scrolling. The mean and standard deviations for the 10 tests were calculated as a single outcome score for each study arm. Response times were measured in milliseconds. The lower the number of milliseconds the faster the response to the random stimuli.|30 minutes post dosing|||milliseconds||Standard Deviation|Mean
745306|NCT00515294|Primary|Lane Position Deviation|The reported lane position deviation indicates the position of the car relative to the center line in feet in the driver simulator. A deviation of 0 indicates no deviation from the center line (the car is positioned farthest from the road edge). Negative numbers indicate deviations to the right of the center line with the car positioned within the lane closer to the road edge. Positive numbers indicate deviations to the left of the center line with the car positioned in the lane of oncoming traffic closer to the road edge|30 minutes post dosing|Driver simulator did not work properly for 6 participants. Their data are not included.||feet||Standard Deviation|Mean
745307|NCT00515437|Secondary|Change in Unstimulated Salivary Flow Rate at Wk 12 Post-injection|"saliva collected over 5 minutes and weighed to produce a grams/minute rate"|baseline vs 12 weeks post-injection|||grams/minute||Standard Deviation|Mean
745308|NCT00515437|Secondary|Change in Unstimulated Salivary Flow Rate at Wk 4 Post-injection|"saliva is collected over 5 minutes and weighed to produce a grams/minute rate"|baseline vs 4 weeks post-injection|||grams/minute||Standard Deviation|Mean
745309|NCT00515437|Secondary|Change in Drooling Frequency and Severity Scale (DFSS) at Wk 12 Post-injection|9 point scale (0=no drooling, 9=severe drooling)|baseline vs 12 weeks post injection|||points on a scale||Standard Deviation|Mean
745310|NCT00515437|Primary|Change in Drooling Frequency & Severity Scale (DFSS)at Wk 4 Post-injection|9 point scale, 0 = no drooling, 9 = severe drooling|baseline versus 4 weeks post-injection|Intent to Treat (ITT)||points on a scale||Standard Deviation|Mean
745311|NCT00515463|Secondary|Number of Participants With Laboratory Toxicity CTCAE Grade Greater or Equal to 3|Participants with laboratory toxicity grade 3 (severe) or 4 (life-threatening), based on the Common Terminology Criteria for Adverse Events (CTCAE), version 3.0.|Day 1 to Month 12|Patients who received ≥ 1 dose of investigational product.||Participants|||Number
745312|NCT00515463|Secondary|Monocytes Change From Baseline at Month 12|Laboratory hematology monocytes|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.||10^9/L||Standard Deviation|Mean
745313|NCT00515463|Secondary|Monocytes Change From Baseline at Month 6|Laboratory hematology monocytes|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.||10^9/L||Standard Deviation|Mean
745314|NCT00515463|Secondary|Monocytes Change From Baseline at Month 1|Laboratory hematology monocytes|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.||10^9/L||Standard Deviation|Mean
745315|NCT00515463|Secondary|Lymphocytes Change From Baseline at Month 12|Laboratory hematology lymphocytes|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.||10^9/L||Standard Deviation|Mean
745316|NCT00515463|Secondary|Lymphocytes Change From Baseline at Month 6|Laboratory hematology lymphocytes|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.||10^9/L||Standard Deviation|Mean
745317|NCT00515463|Secondary|Lymphocytes Change From Baseline at Month 1|Laboratory hematology lymphocytes|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.||10^9/L||Standard Deviation|Mean
745318|NCT00515463|Secondary|Basophils Change From Baseline at Month 12|Laboratory hematology basophils|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.||10^9/L||Standard Deviation|Mean
745319|NCT00515463|Secondary|Basophils Change From Baseline at Month 6|Laboratory hematology basophils|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.||10^9/L||Standard Deviation|Mean
745320|NCT00515463|Secondary|Basophils Change From Baseline at Month 1|Laboratory hematology basophils|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.||10^9/L||Standard Deviation|Mean
745321|NCT00515463|Secondary|Eosinophils Change From Baseline at Month 12|Laboratory hematology eosinophils|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.||10^9/L||Standard Deviation|Mean
745322|NCT00515463|Secondary|Eosinophils Change From Baseline at Month 6|Laboratory hematology eosinophils|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.||10^9/L||Standard Deviation|Mean
745323|NCT00515463|Secondary|Eosinophils Change From Baseline at Month 1|Laboratory hematology eosinophils|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.||10^9/L||Standard Deviation|Mean
745324|NCT00515463|Secondary|Total Neutrophils Change From Baseline at Month 12|Laboratory hematology total neutrophils|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.||10^9/L||Standard Deviation|Mean
745325|NCT00515463|Secondary|Total Neutrophils Change From Baseline at Month 6|Laboratory hematology total neutrophils|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.||10^9/L||Standard Deviation|Mean
745326|NCT00515463|Secondary|Total Neutrophils Change From Baseline at Month 1|Laboratory hematology total neutrophils|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.||10^9/L||Standard Deviation|Mean
745327|NCT00515463|Secondary|White Blood Cells Change From Baseline at Month 12|Laboratory hematology white blood cells|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.||10^9/L||Standard Deviation|Mean
745328|NCT00515463|Secondary|White Blood Cells Change From Baseline at Month 6|Laboratory hematology white blood cells|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.||10^9/L||Standard Deviation|Mean
745329|NCT00515463|Secondary|White Blood Cells Change From Baseline at Month 1|Laboratory hematology white blood cells|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.||10^9/L||Standard Deviation|Mean
745330|NCT00515463|Secondary|Platelets Change From Baseline at Month 12|Laboratory hematology platelets|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.||10^9/L||Standard Deviation|Mean
745331|NCT00515463|Secondary|Platelets Change From Baseline at Month 6|Laboratory hematology platelets|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.||10^9/L||Standard Deviation|Mean
745332|NCT00515463|Secondary|Platelets Change From Baseline at Month 1|Laboratory hematology platelets|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.||10^9/L||Standard Deviation|Mean
745333|NCT00515463|Secondary|Reticulocytes Change From Baseline at Month 12|Laboratory hematology reticulocytes|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.||10^9/L||Standard Deviation|Mean
745334|NCT00515463|Secondary|Reticulocytes Change From Baseline at Month 6|Laboratory hematology reticulocytes|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.||10^9/L||Standard Deviation|Mean
745335|NCT00515463|Secondary|Reticulocytes Change From Baseline at Month 1|Laboratory hematology reticulocytes|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.||10^9/L||Standard Deviation|Mean
745336|NCT00515463|Secondary|Hemoglobin Change From Baseline at Month 12|Laboratory hematology hemoglobin|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.||g/L||Standard Deviation|Mean
745337|NCT00515463|Secondary|Hemoglobin Change From Baseline at Month 6|Laboratory hematology hemoglobin|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.||g/L||Standard Deviation|Mean
745338|NCT00515463|Secondary|Hemoglobin Change From Baseline at Month 1|Laboratory hematology hemoglobin|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.||g/L||Standard Deviation|Mean
745339|NCT00515463|Secondary|Red Blood Cells Change From Baseline at Month 12|Laboratory hematology red blood cells|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.||10^12/L||Standard Deviation|Mean
745340|NCT00515463|Secondary|Red Blood Cells Change From Baseline at Month 6|Laboratory hematology red blood cells|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.||10^12/L||Standard Deviation|Mean
745341|NCT00515463|Secondary|Red Blood Cells Change From Baseline at Month 1|Laboratory hematology red blood cells|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.||10^12/L||Standard Deviation|Mean
745342|NCT00515463|Secondary|Glucose Change From Baseline at Month 12|Laboratory chemistry glucose|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.||mmol/L||Standard Deviation|Mean
745343|NCT00515463|Secondary|Glucose Change From Baseline at Month 6|Laboratory chemistry glucose|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.||mmol/L||Standard Deviation|Mean
745344|NCT00515463|Secondary|Glucose Change From Baseline at Month 1|Laboratory chemistry glucose|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.||mmol/L||Standard Deviation|Mean
745345|NCT00515463|Secondary|Total Protein Change From Baseline at Month 12|Laboratory chemistry total protein|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.||g/L||Standard Deviation|Mean
745346|NCT00515463|Secondary|Total Protein Change From Baseline at Month 6|Laboratory chemistry total protein|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.||g/L||Standard Deviation|Mean
745347|NCT00515463|Secondary|Total Protein Change From Baseline at Month 1|Laboratory chemistry total protein|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.||g/L||Standard Deviation|Mean
745348|NCT00515463|Secondary|Albumin Change From Baseline at Month 12|Laboratory chemistry albumin|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.||g/L||Standard Deviation|Mean
745349|NCT00515463|Secondary|Albumin Change From Baseline at Month 6|Laboratory chemistry albumin|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.||g/L||Standard Deviation|Mean
745350|NCT00515463|Secondary|Albumin Change From Baseline at Month 1|Laboratory chemistry albumin|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.||g/L||Standard Deviation|Mean
745351|NCT00515463|Secondary|Total Bilirubin Change From Baseline at Month 12|Laboratory chemistry total bilirubin|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.||umol/L||Standard Deviation|Mean
745352|NCT00515463|Secondary|Total Bilirubin Change From Baseline at Month 6|Laboratory chemistry total bilirubin|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.||umol/L||Standard Deviation|Mean
745353|NCT00515463|Secondary|Total Bilirubin Change From Baseline at Month 1|Laboratory chemistry total bilirubin|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.||umol/L||Standard Deviation|Mean
745354|NCT00515463|Secondary|Alanine Amino Transferase Change From Baseline at Month 12|Laboratory chemistry alanine amino transferase|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.||U/L||Standard Deviation|Mean
745355|NCT00515463|Secondary|Alanine Amino Transferase Change From Baseline at Month 6|Laboratory chemistry alanine amino transferase|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.||U/L||Standard Deviation|Mean
745356|NCT00515463|Secondary|Alanine Amino Transferase Change From Baseline at Month 1|Laboratory chemistry alanine amino transferase|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.||U/L||Standard Deviation|Mean
745357|NCT00515463|Secondary|Aspartate Amino Transferase Change From Baseline at Month 12|Laboratory chemistry aspartate amino transferase|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.||U/L||Standard Deviation|Mean
745358|NCT00515463|Secondary|Aspartate Amino Transferase Change From Baseline at Month 6|Laboratory chemistry aspartate amino transferase|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.||U/L||Standard Deviation|Mean
745359|NCT00515463|Secondary|Aspartate Amino Transferase Change From Baseline at Month 1|Laboratory chemistry aspartate amino transferase|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.||U/L||Standard Deviation|Mean
745360|NCT00515463|Secondary|Creatinine Change From Baseline at Month 12|Laboratory chemistry creatinine|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.||umol/L||Standard Deviation|Mean
745361|NCT00515463|Secondary|Creatinine Change From Baseline at Month 6|Laboratory chemistry creatinine|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.||umol/L||Standard Deviation|Mean
745362|NCT00515463|Secondary|Creatinine Change From Baseline at Month 1|Laboratory chemistry creatinine|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.||umol/L||Standard Deviation|Mean
745363|NCT00515463|Secondary|Blood Urea Nitrogen Change From Baseline at Month 12|Laboratory chemistry blood urea nitrogen|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.||mmol/L||Standard Deviation|Mean
745364|NCT00515463|Secondary|Blood Urea Nitrogen Change From Baseline at Month 6|Laboratory chemistry blood urea nitrogen|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.||mmol/L||Standard Deviation|Mean
745365|NCT00515463|Secondary|Blood Urea Nitrogen Change From Baseline at Month 1|Laboratory chemistry blood urea nitrogen|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.||mmol/L||Standard Deviation|Mean
745366|NCT00515463|Secondary|Magnesium Change From Baseline at Month 12|Laboratory chemistry magnesium|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.||mmol/L||Standard Deviation|Mean
745367|NCT00515463|Secondary|Magnesium Change From Baseline at Month 6|Laboratory chemistry magnesium|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.||mmol/L||Standard Deviation|Mean
745368|NCT00515463|Secondary|Magnesium Change From Baseline at Month 1|Laboratory chemistry magnesium|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.||mmol/L||Standard Deviation|Mean
745369|NCT00515463|Secondary|Bicarbonate Change From Baseline at Month 12|Laboratory chemistry bicarbonate|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.||mmol/L||Standard Deviation|Mean
745370|NCT00515463|Secondary|Bicarbonate Change From Baseline at Month 6|Laboratory chemistry bicarbonate|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.||mmol/L||Standard Deviation|Mean
780810|NCT00790647|Secondary|Number of Participants Surviving at 100 Days From Transplant||100 Days from transplant date|||participants|||Number
745371|NCT00515463|Secondary|Bicarbonate Change From Baseline at Month 1|Laboratory chemistry bicarbonate|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.||mmol/L||Standard Deviation|Mean
745372|NCT00515463|Secondary|Chloride Change From Baseline at Month 12|Laboratory chemistry chloride|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.||mmol/L||Standard Deviation|Mean
745373|NCT00515463|Secondary|Chloride Change From Baseline at Month 6|Laboratory chemistry chloride|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.||mmol/L||Standard Deviation|Mean
745374|NCT00515463|Secondary|Chloride Change From Baseline at Month 1|Laboratory chemistry chloride|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.||mmol/L||Standard Deviation|Mean
745375|NCT00515463|Secondary|Potassium Change From Baseline at Month 12|Laboratory chemistry potassium|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.||mmol/L||Standard Deviation|Mean
745376|NCT00515463|Secondary|Potassium Change From Baseline at Month 6|Laboratory chemistry potassium|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.||mmol/L||Standard Deviation|Mean
745377|NCT00515463|Secondary|Potassium Change From Baseline at Month 1|Laboratory chemistry potassium|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.||mmol/L||Standard Deviation|Mean
745378|NCT00515463|Secondary|Sodium Change From Baseline at Month 12|Sodium Change From Baseline at Month 12|Baseline, Month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.||mmol/L||Standard Deviation|Mean
745379|NCT00515463|Secondary|Sodium Change From Baseline at Month 6|Laboratory chemistry sodium|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.||mmol/L||Standard Deviation|Mean
745380|NCT00515463|Secondary|Sodium Change From Baseline at Month 1|Laboratory chemistry sodium|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.||mmol/L||Standard Deviation|Mean
745381|NCT00515463|Secondary|Number of Participants With Neutralizing Antibodies Against Denosumab at Month 12|Samples demonstrating reactivity for binding antibodies to denosumab were to be tested for neutralizing or inhibitory effects in a cell-based bioassay.|Month 12|Patients testing positive for binding antibodies to denosumab.|||||
745382|NCT00515463|Secondary|Number of Participants Who Tested Positive for Anti-denosumab Antibodies at Month 12|An electrochemiluminescent bridging immunoassay was used to test blood samples for binding antibodies to denosumab.|12 months|Patients who received ≥ 1 dose of investigational product, have a baseline and ≥ 1 post-baseline antibody assessment and did not have binding anti-denosumab antibodies present at baseline, and with evaluable antibody results at 12 months.||Participants|||Number
745383|NCT00515463|Primary|Number of Participants Who Tested Positive for Anti-denosumab Antibodies at Month 6|An electrochemiluminescent bridging immunoassay was used to test blood samples for binding antibodies to denosumab.|6 months|Patients who received ≥ 1 dose of investigational product, have a baseline and ≥ 1 post-baseline antibody assessment and did not have binding anti-denosumab antibodies present at baseline, and with evaluable antibody results at 6 months.||Participants|||Number
745384|NCT00515502|Secondary|Mean Serial Specific Airway Resistance (sGaw) Over 24 Hours After Dosing on Day 1 of Each Treatment Period|sGaw is the specific airways resistance (mid) which was assessed by whole body plethysmography. Values used were the mean of the 3 readings recorded at each timepoint. sGaw measurements were taken at 2 hour (h), 6 h, 12 h and 24 h post-dose of each treatment period. 1/kPa.s=1(the inverses)/kPa (kilopascal).s (second)|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been summarized for different parameters/at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||1/kPa*s||Standard Error|Geometric Mean
745385|NCT00515502|Secondary|Mean Serial FEV1over 24 Hours After Dosing on Day 1 of Each Treatment Period|Serial spirometry assessments were conducted on Day 1 of each treatment period over the course of 24 hours and were taken at 1 hour (h), 2 h, 6 h, 9 h, 12 h and 24 h post-dose. The maximum of the 3 FEV1 measurements for each participant, treatment period and timepoint were used in the calculation of the mean for each treatment group at each timepoint.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been summarized for different parameters/at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Liters||Standard Error|Least Squares Mean
745386|NCT00515502|Secondary|Fraction of Dose Excreted Unchanged in Urine From Time Zero to: 24 Hours [Fe(0-24)] and 48 Hours [Fe(0-48)] for UMEC|Urine samples were collected to determine the urine concentrations of UMEC from 0 min up to 48 hours post-dose of each treatment period to derive Fe(0-24) and Fe(0-48). Urine samples for PK analysis of UMEC were obtained on Day 1; a single sample was collected at each of the following timepoints: 0–2 h, 2–8 h, 8–12 h, 12–24 h and 24–48 h post UMEC dose administration.|Day 1 of each treatment period (up to Study Day 46)|PK Population||Percentage of total dose administered||Full Range|Median
745387|NCT00515502|Secondary|Half-life for Renal Excretion of UMEC on Day 1|The terminal half-life (t1/2) of UMEC is defined as the time required for the urine concentration of UMEC to reach half of its original concentration. Urine samples for PK analysis of UMEC were obtained on Day 1; a single sample was collected at each of the following timepoints: 0–2 h, 2–8 h, 8–12 h, 12–24 h and 24–48 h post UMEC dose administration.|Day 1 of each treatment period (up to Study Day 46)|PK Population||Hours||Geometric Coefficient of Variation|Geometric Mean
745388|NCT00515502|Secondary|Renal Clearance (CLr) of UMEC Following Dose Administration on Day 1|The CLr is defined as the apparent total clearance of the drug from plasma after oral administration. Blood samples for PK analysis of UMEC were obtained on Day 1at pre-dose and 5 minutes (min), 15 min, 30 min, 1 hour (h), 2 h, 4 h, 6 h, 8 h, 12 h, 16 h, and 24 h post UMEC dose administration.|Day 1 of each treatment period (up to Study Day 46)|PK Population||Liters per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
745389|NCT00515502|Secondary|Amount of Drug Excreted Unchanged in Urine From Time Zero to: 2h [Ae(0-2)] , 8h [Ae(0-8)], 12h [Ae(0-12)], 24h [Ae(0-24)], and 48h [Ae(0-48)]; and Area Under the Excretion Rate Curve From Time Zero to: 18h [AUER(0-18)] and 36h [AUER(0-36)] for UMEC|Urine samples were collected to determine the urine concentrations of UMEC from 0 min up to 48 hours post-dose of each treatment period to derive Ae(0-2), Ae(0-8), Ae(0-12), Ae(0-24), Ae(0-48), AUER(0-18) and AUER(0-36). Urine samples for PK analysis of UMEC were obtained on Day 1; a single sample was collected at each of the following timepoints: 0–2 h, 2–8 h, 8–12 h, 12–24 h and 24–48 h post UMEC dose administration.|Day 1 of each treatment period (up to Study Day 46)|PK Population||ng||Geometric Coefficient of Variation|Geometric Mean
745390|NCT00515502|Secondary|Time of Maximum Observed Plasma Concentration (Tmax), Last Time Point Where the Concentration is Above the Limit of Quantification (Tlast), and Plasma Half-life (t1/2) of UMEC|Blood samples were collected to determine the plasma concentrations of UMEC from pre-dose up to 24 hour post-dose of each treatment period to derive tmax, tlast and t1/2. Blood samples for PK analysis of UMEC were obtained on Day 1at pre-dose and 5 minutes (min), 15 min, 30 min, 1 hour (h), 2 h, 4 h, 6 h, 8 h, 12 h, 16 h, and 24 h post UMEC dose administration.|Day 1 of each treatment period (up to Study Day 46)|PK Population. Only those participants with non-missing observations (including non-calculable values) were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters/at different time points, so the overall number of participants analyzed reflects everyone in the PK Population||Hours||Full Range|Median
745391|NCT00515502|Secondary|Maximum Observed Plasma Concentration (Cmax) of UMEC|Blood samples were collected to determine the plasma concentrations of UMEC from pre-dose up to 24 hour post-dose of each treatment period to derive the Cmax. Blood samples for PK analysis of UMEC were obtained on Day 1at pre-dose and 5 minutes (min), 15 min, 30 min, 1 hour (h), 2 h, 4 h, 6 h, 8 h, 12 h, 16 h, and 24 h post UMEC dose administration.|Day 1 of each treatment period (up to Study Day 46)|PK Population||ng/mL||Geometric Coefficient of Variation|Geometric Mean
745392|NCT00515502|Secondary|Area Under Concentration-time Curve From Time 0 to 2 Hours [AUC(0-2)] and Area Under Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration [AUC(0-t)] of UMEC|Blood samples were collected to determine the plasma concentrations of UMEC from pre-dose up to 24 hour post-dose of each treatment period to derive the AUC(0-2) and AUC(0-t). Blood samples for PK analysis of UMEC were obtained on Day 1at pre-dose and 5 minutes (min), 15 min, 30 min, 1 hour (h), 2 h, 4 h, 6 h, 8 h, 12 h, 16 h, and 24 h post UMEC dose administration.|Day 1 of each treatment period (up to Study Day 46)|Pharmacokinetic (PK) Population:all participants in the All Subjects Population for whom a PK sample was obtained and analyzed.||hr * nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
745393|NCT00515502|Primary|Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at the Indicated Time Points on Day 1 of Each Treatment Period|FEV1 and FVC are measures of lung function. FEV1 is defined as the maximal amount of air that can be forcefully exhaled in one second. FVC is defined as the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. FEV1 and FVC measurements were taken at pre-dose and 1 hour (h), 2 h, 6 h, 9 h, 12 h and 24 h post-dose of each treatment period.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been summarized for different parameters/at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Liters||Standard Deviation|Mean
745394|NCT00515502|Primary|Calcium, Bicarbonate, Chloride, Glucose, Inorganic Phosphorus (IP), Potassium, Sodium, and Urea Values at the Indicated Time Points on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of the calcium, bicarbonate, chloride, glucose, IP, potassium, sodium, and urea at pre-dose and 24 hour (h) post-dose of each treatment period.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters/at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Millimoles per liter (mmol/L)||Standard Deviation|Mean
745395|NCT00515502|Primary|Total Bilirubin, Creatinine and Uric Acid Values at the Indicated Time Points on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of total bilirubin, creatinine, and uric acid at pre-dose and 24 hour (h) post-dose of each treatment period.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population||Micromoles per liter (µmol/L)||Standard Deviation|Mean
745396|NCT00515502|Primary|Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Phosphokinase (CPK), and Gamma Glutamyl Transferase (GGT) Values at the Indicated Time Points on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of ALP, ALT, AST, CPK, and GGT at pre-dose and 24 hour (h) post-dose of each treatment period.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been summarized for different parameters/at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||International units per liter (IU/L)||Standard Deviation|Mean
745397|NCT00515502|Primary|Platelets Count and White Blood Cells (WBC) Count Values at the Indicated Time Points on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of platelets count and WBC count at pre-dose and 24 hour (h) post-dose of each treatment period.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population||10^9 cells per liter (GI/L)||Standard Deviation|Mean
745398|NCT00515502|Primary|Red Blood Cells Count Values at the Indicated Time Points on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of the red blood cells count at pre-dose and 24 hour (h) post-dose of each treatment period.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population||10^12 cells per liter (TI/L)||Standard Deviation|Mean
745399|NCT00515502|Primary|Mean Corpuscle Volume Values at the Indicated Time Points on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of the mean corpuscle volume at pre-dose and 24 hour (h) post-dose of each treatment period.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population||Femtoliters (FL)||Standard Deviation|Mean
781843|NCT00799292|Primary|Intra-operative Blood Loss During Vaginal Hysterectomy||Blood loss will be assessed at the end of the operative procedure||||||
745400|NCT00515502|Primary|Mean Corpuscle Hemoglobin Values at the Indicated Time Points on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of the mean corpuscle hemoglobin at pre-dose and 24 hour (h) post-dose of each treatment period.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population||picograms/cell (pg)||Standard Deviation|Mean
745401|NCT00515502|Primary|Hematocrit Values at the Indicated Time Points on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of hematocrit at pre-dose and 24 hour (h) post-dose of each treatment period.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population||Proportion of red blood cells in blood||Standard Deviation|Mean
745402|NCT00515502|Primary|Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC), Albumin and Total Protein Values at the Indicated Time Points on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of hemoglobin, MCHC, albumin and total protein at pre-dose and 24 hour (h) post-dose of each treatment period.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population||Grams per liter (G/L)||Standard Deviation|Mean
745403|NCT00515502|Primary|Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils Values at the Indicated Time Points on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, and total neutrophils at pre-dose and 24 hour (h) post-dose of each treatment period.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population||Percentage||Standard Deviation|Mean
745404|NCT00515502|Primary|Mean (0-24 Hours) Heart Rate as Measured From Holter Monitoring at Day 1 of Each Treatment Period|Twenty-four-hour Holter monitoring was conducted to measure heart rate for the 24-h period following dosing of each treatment period and the mean value for heart rate (0-24 hours) was derived. Analysis was performed using a mixed model of period and treatment group fitted as fixed effects and participant as a random effect.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population. All participants with >=1 post-Baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 1.||Beats per minute (bpm)||Standard Error|Least Squares Mean
745405|NCT00515502|Primary|Maximum (0-24 Hours) Heart Rate as Measured From Holter Monitoring at Day 1 of Each Treatment Period|Twenty-four hour Holter monitoring was conducted to measure heart rate for the 24-hour period following dosing at each treatment period and the maximum value for heart rate (0-24 hours) was derived. Analysis was performed using a mixed model of period and treatment group fitted as fixed effects and participant as a random effect.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population. All participants with >=1 post-Baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 1.||Beats per minute (bpm)||Standard Error|Least Squares Mean
745406|NCT00515502|Primary|Weighted Mean (0-4 Hours) QTcF at Day 1 of Each Treatment Period|Twelve-lead ECGs were performed to measure QTcF at pre-dose and 15 minutes (min), 45 min, 1.5 hours (h), 4 h, 8 h and 24 h post-dose of each treatment period and the weighted mean value for QTcF (0-4 hours) was derived. Baseline is the mean of the 3 pre-dose measurements for each period. Participant level Baseline is the mean of the Baselines for each participant and period level Baseline is the difference between the Baseline and the participant level Baseline in each treatment period for each participant. Analysis was performed using a mixed model with participant level Baseline, period level Baseline, period and treatment group were fitted as fixed effects and participant as a random effect.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population. All participants with >=1 post-Baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 1.||Milliseconds (msec)||Standard Error|Least Squares Mean
745407|NCT00515502|Primary|Maximum (0-4 Hours) QTcF at Day 1 of Each Treatment Period|Twelve-lead ECGs were performed to measure QT interval corrected according to Fredericia’s formula (QTcF) at pre-dose and 15 minutes (min), 45 min, 1.5 hours (h), 4 h, 8 h and 24 h post-dose of each treatment period and the maximum value for QTcF (0-4 hours) was derived. Baseline is the mean of the 3 pre-dose measurements for each period. Participant level Baseline is the mean of the Baselines for each participant and period level Baseline is the difference between the Baseline and the participant level Baseline in each treatment period for each participant. Analysis was performed using a mixed model with participant level Baseline, period level Baseline, period and treatment group were fitted as fixed effects and participant as a random effect.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population. All participants with >=1 post-Baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 1.||Milliseconds (msec)||Standard Error|Least Squares Mean
745408|NCT00515502|Primary|Weighted Mean (0-4 Hours) QTcB at Day 1 of Each Treatment Period|Twelve-lead ECGs were performed to measure QTcB at pre-dose and 15 minutes (min), 45 min, 1.5 hours (h), 4 h, 8 h and 24 h post-dose of each treatment period and the weighted mean value for QTcB (0-4 hours) was derived. Baseline is the mean of the 3 pre-dose measurements for each period. Participant level Baseline is the mean of the Baselines for each participant and period level Baseline is the difference between the Baseline and the participant level Baseline in each treatment period for each participant. Analysis was performed using a mixed model with participant level Baseline, period level Baseline, period and treatment group were fitted as fixed effects and participant as a random effect.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population. All participants with >=1 post-Baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 1.||Milliseconds (msec)||Standard Error|Least Squares Mean
745415|NCT00515502|Primary|Maximum (0-4 Hours) Heart Rate on Day 1 of Each Treatment Period|Resting heart rate was measured at pre-dose and 15 minutes (min), 45min, 1.5 hour (h) 4 h, 8 h, and 24 h post-dose of each treatment period and the maximum value for heart rate (0-4hours) was derived at rest. Baseline is the mean of the 3 pre-dose measurements for each period. Participant level Baseline is the mean of the Baselines for each participant and period level Baseline is the difference between the Baseline and the participant level Baseline in each treatment period for each participant. Analysis was performed using a mixed model with participant level Baseline, period level Baseline, period and treatment group were fitted as fixed effects and participant as a random effect.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population. All participants with >=1 post-Baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 1.||Beats per minute (bpm)||Standard Error|Least Squares Mean
745409|NCT00515502|Primary|Maximum (0-4 Hours) QTcB at Day 1 of Each Treatment Period|Twelve-lead ECGs (electrocardiograms) were performed to measure QT interval corrected according to Bazzet's formula (QTcB) at pre-dose and 15 minutes (min), 45 min, 1.5 hours (h), 4 h, 8 h and 24 h post-dose of each treatment period and the maximum value for QTcB (0-4 hours) was derived. Baseline is the mean of the 3 pre-dose measurements for each period. Participant level Baseline is the mean of the Baselines for each participant and period level Baseline is the difference between the Baseline and the participant level Baseline in each treatment period for each participant. Analysis was performed using a mixed model with participant level Baseline, period level Baseline, period and treatment group were fitted as fixed effects and participant as a random effect.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population. All participants with >=1 post-Baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 1.||Milliseconds (msec)||Standard Error|Least Squares Mean
745410|NCT00515502|Primary|Weighted Mean (0-4 Hours) Diastolic Blood Pressure at Day 1 of Each Treatment Period|Resting diastolic blood pressure was measured at pre-dose and 15 minutes (min), 45 min, 1.5 hours (h), 4 h, 8 h and 24 h post-dose of each treatment period and the weighted mean value for diastolic blood pressure (0-4 hours) was derived. Baseline is the mean of the 3 pre-dose measurements for each period. Participant level Baseline is the mean of the Baselines for each participant and period level Baseline is the difference between the Baseline and the participant level Baseline in each treatment period for each participant. Analysis was performed using a mixed model with participant level Baseline, period level Baseline, period and treatment group were fitted as fixed effects and participant as a random effect.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population. All participants with >=1 post-Baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 1.||Millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
745411|NCT00515502|Primary|Maximum (0-4 Hours) Diastolic Blood Pressure at Day 1 of Each Treatment Period|Resting diastolic blood pressure was measured at pre-dose and 15 minutes (min), 45 min, 1.5 hours (h), 4 h, 8 h and 24 h post-dose of each treatment period and the maximum value for diastolic blood pressure (0-4 hours) was derived. Baseline is the mean of the 3 pre-dose measurements for each period. Participant level Baseline is the mean of the Baselines for each participant and period level Baseline is the difference between the Baseline and the participant level Baseline in each treatment period for each participant. Analysis was performed using a mixed model with participant level Baseline, period level Baseline, period and treatment group were fitted as fixed effects and participant as a random effect.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population. All participants with >=1 post-Baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 1.||Millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
745412|NCT00515502|Primary|Weighted Mean (0-4 Hours) Systolic Blood Pressure at Day 1 of Each Treatment Period|Resting systolic blood pressure was measured at pre-dose and 15 minutes (min), 45 min, 1.5 hours (h), 4 h, 8 h and 24 h post-dose of each treatment period and the weighted mean value for systolic blood pressure (0-4 hours) was derived. Baseline is the mean of the 3 pre-dose measurements for each period. Participant level Baseline is the mean of the Baselines for each participant and period level Baseline is the difference between the Baseline and the participant level Baseline in each treatment period for each participant. Analysis was performed using a mixed model with participant level Baseline, period level Baseline, period and treatment group were fitted as fixed effects and participant as a random effect.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population. All participants with >=1 post-Baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 1.||Millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
745413|NCT00515502|Primary|Maximum (0-4 Hours) Systolic Blood Pressure at Day 1 of Each Treatment Period|Resting systolic blood pressure was measured at pre-dose and 15 minutes (min), 45 min, 1.5 hours (h), 4 h, 8 h and 24 h post-dose of each treatment period and the maximum value for systolic blood pressure (0-4 hours) was derived. Baseline is the mean of the 3 pre-dose measurements for each period. Participant level Baseline is the mean of the Baselines for each participant and period level Baseline is the difference between the Baseline and the participant level Baseline in each treatment period for each participant. Analysis was performed using a mixed model with participant level Baseline, period level Baseline, period and treatment group were fitted as fixed effects and participant as a random effect.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population. All participants with >=1 post-Baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 1.||Millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
745414|NCT00515502|Primary|Weighted Mean (0-4 Hours) Heart Rate at Day 1 of Each Treatment Period|Resting heart rate was measured at pre-dose and 15 minutes (min), 45 min, 1.5 hours (h), 4 h, 8 h and 24 h post-dose of each treatment period and the weighted mean value for heart rate (0-4 hours) was derived. Baseline is the mean of the 3 pre-dose measurements for each period. Participant level Baseline is the mean of the Baselines for each participant and period level Baseline is the difference between the Baseline and the participant level Baseline in each treatment period for each participant. Analysis was performed using a mixed model with participant level Baseline, period level Baseline, period and treatment group were fitted as fixed effects and participant as a random effect.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population. All participants with >=1 post-Baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 1.||Beats per minute (bpm)||Standard Error|Least Squares Mean
745426|NCT00515671|Secondary|Psychiatric Symptoms (PANSS Total)|Psychiatric symptomatology was assessed by the Positive and Negative Syndrome Scale (PANSS), a widely-used, 30-item rating scale. The PANSS has previously demonstrated satisfactory internal consistency, test-retest reliability, and validity. Raters were trained to reach inter-rater agreement of .80 prior to interviewing participants. This is the total score, which ranges from 30 to 210, with higher scores indicating more severe symptoms.|Baseline, 9 months, 18 months|||units on a scale||Standard Deviation|Mean
745458|NCT00516074|Secondary|Change in Daytime Heart Rate From Baseline to Endpoint|Change from baseline to endpoint in daytime heart rate as measured by an ambulatory blood pressure monitor|12 weeks|Intent to treat; Last observation carried forward||beats per minute||Standard Error|Least Squares Mean
745416|NCT00515502|Primary|Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs and SAEs.|From Day 1 of Treatment Period 1until Follow-up (up to 10 weeks)|All Subjects Population: all participants who received at least one dose of study medication.||Participants|||Number
745417|NCT00515541|Primary|EQELS (Electrophoretic Quasi Elastic Light Scattering: Change in Mobility After the Addition of Arachidonic Acid|Measurements were made using a modified device (EQELS) to specifications of constant current, high electric field and a scattering angle of 30 degrees. EQELS provides a sensitive assessment of subtle changes in the cell surface that occurs with activation, ligand binding or apoptosis. These changes are the result of different distributions of charged groups that define a surface charge finger print for the current state of activation of the cell. Resting state platelets have a negative surface charge, whereas fully activated platelets have a positive surface charge.|up to and including closeout at 24 weeks|Based on number of subjects completing 24 weeks. Change in EQELS value after the addition of Arachidonic Acid.||mobility units||Inter-Quartile Range|Median
745418|NCT00515541|Primary|Bleeding Time|Bleeding time is a measure of how well platelets interact with blood vessel walls to form a clot. A manual blood pressure cuff is placed 2 inches above the antecubital fossa and inflated to 40mmHg. Using a standard Surgicutt device, a small incision is made and a stopwatch is started. The incision edge is blotted at 30 second intervals with standard filter paper until the bleeding has stopped. The time to hemostasis is noted.|up to and including closeout at 24 weeks|Based on number of subjects completing 24 weeks||seconds||Inter-Quartile Range|Median
745419|NCT00515541|Secondary|The Occurence of Any Type of Bleeding|was there any bleeding occurance during the accessed interval|up to and including closeout at 24 weeks|Subjects would indicate if they had any bleeding episode during the trial at each of their testing intervals||Number of occurance|||Number
745420|NCT00515541|Primary|Platelet Aggegation (Arachiodonic Acid)Using a PAP-8E (BioData Corp.)|The PAP-8E measures platelet aggregation in platelet rich plasma (PRP). Platelet responses to a series of common agonists cause changes in optical density that are measured. The instrument is blanked (100% baseline (optimal transmission)) by inserting a platelet poor plasma (PPP) specimen into the appropriate channel. The PRP is then inserted into the same well. The difference in optical density between the PPP and the PRP 0% baseline (optical transmission) is recorded for several minutes when the agonist reagent is added to the PRP.|up to and including closeout at 24 weeks|Based on number of subjects completing 24 weeks||percent||Inter-Quartile Range|Median
745421|NCT00515619|Secondary|Percentage of at Least 50% Responders During the Treatment Period (up to 5.5 Years)|At least 50 percent response is based on the percentage reduction in 28-day seizure frequency during the Treatment Period of the open-label extension relative to the Baseline Phase of the prior study. This endpoint reflects the percentage of subjects with at least 50% reduction (ie, at least 50% change) in 28-day partial onset seizure frequency|Treatment Period (up to 5.5 years)|Of the 376 subjects who were enrolled/treated in the study, 376 are included in this summary based on the Full Analysis Set (FAS). FAS population: number of subjects treated with at least 1 post-baseline seizure diary day with available data during the SP774 study.||Percentage of subjects|||Number
745422|NCT00515619|Secondary|Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (up to 5.5 Years)|"Median percentage change is the median value with respect to the percent change from Baseline across the population of subjects. Percentage change is calculated as 100 times the difference of the seizure frequency for the treatment period and the Baseline seizure frequency divided by the baseline seizure frequency.
Negative changes from Baseline indicate an improvement (i.e., a reduction) in 28-day seizure frequency."|Baseline, Treatment Period (up to 5.5 years)|Of the 376 subjects who were enrolled/treated in the study, 376 are included in this summary based on the Full Analysis Set (FAS). FAS population: number of subjects treated with at least 1 post-baseline seizure diary day with available data during the SP774 study.||Percentage change||Full Range|Median
745423|NCT00515619|Primary|Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (up to 5.5 Years)|A serious adverse event is any untoward medical occurrences in a subject administered study treatment, whether or not the event is related to treatment, with at least one of the follow outcomes: death, life-threatening, initial inpatient hospitalization or prolongation of hospitalization, significant or persistent disability/incapacity, congenital anomaly/birth defect, or an important medical event that may jeopardize the subject and require a medical/surgical intervention.|During the Treatment Period (up to 5.5 years)|Of the 376 subjects who entered the study, 376 are included in this summary based on the Safety Set (SS). SS population: number of subjects treated.||Subjects|||Number
745424|NCT00515619|Primary|Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (up to 5.5 Years)|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|During the Treatment Period (up to 5.5 years)|Of the 376 subjects who entered the study, 376 are included in this summary based on the Safety Set (SS). SS population: number of subjects treated.||Subjects|||Number
745425|NCT00515619|Primary|Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) During the Treatment Period (up to 5.5 Years)|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|During the Treatment Period (up to 5.5 years)|Of the 376 subjects who entered the study, 376 are included in this summary based on the Safety Set (SS). SS population: number of subjects treated.||Subjects|||Number
745456|NCT00516074|Secondary|Change in Mean 24 Hour Systolic Blood Pressure From Baseline to Endpoint|Change from baseline to endpoint in average systolic blood pressure measured over 24 hours by an ambulatory blood pressure monitor|12 weeks|Intent to treat; Last observation carried forward||mmHg||Standard Error|Least Squares Mean
745427|NCT00515671|Primary|Illness Management Ratings|Illness self-management was assessed with the consumer-rated Illness Management and Recovery Scale. Items are rated on a 5-point behaviorally anchored scale; the mean across all 15 items forms an overall score of illness management (ranging from 1 to 5), with higher scores indicating better self-management.|Baseline, 9 months, 18 months|||units on a scale||Standard Deviation|Mean
745428|NCT00515697|Secondary|Summary Listing of Participants Reporting Drug-Related Treatment-Emergent Adverse Events|Data presented are the number of participants who experienced treatment-emergent adverse events (TEAE), serious adverse events (SAE), Grade 3 or 4 TEAE, or adverse events (AE) leading to discontinuation of treatment that were considered to be related to ramucirumab. A summary of SAEs and other nonserious AEs, regardless of causality, is located in the Reported Adverse Events section.|First dose to study completion (up to 34 months) plus 30-day safety follow-up|Intent-to-treat population: participants who received any quantity of ramucirumab.||participants|||Number
745429|NCT00515697|Secondary|Maximum Concentration (Cmax) of Ramucirumab||1 hour after the end of the Week 32 infusion treatment [Cycle 16 (1 cycle=14 days)]|Participants who received any quantity of ramucirumab and had evaluable pharmacokinetic data at the specified time point.||micrograms per milliliter (mcg/mL)||Standard Deviation|Mean
745430|NCT00515697|Secondary|Minimum Concentration (Cmin) of Ramucirumab||Immediately prior to the Week 32 infusion treatment [Cycle 16 (1 cycle=14 days)]|Participants who received any quantity of ramucirumab and had evaluable pharmacokinetic data at the specified time point.||micrograms per milliliter (mcg/mL)||Standard Deviation|Mean
745431|NCT00515697|Secondary|Median Duration of Overall Response|Duration of response is the interval from the date of initial documented response [confirmed complete response (CR) or partial response (PR)] to the first documented date of disease progression as classified according to Response Evaluation Criteria In Solid Tumors (RECIST version 1.0) criteria, or initiation of other (or additional) antitumor therapy is first reported, or death due to any cause. CR is the disappearance of all target and non-target lesions and the normalization of tumor marker levels. PR is having at least a 30% decrease in the sum of the longest diameter of target lesions without new lesions and progression of non-target lesions. Disease progression is having at least a 20% increase in the sum of the longest diameter of target lesions and/or unequivocal progression of a non-target lesion and/or detection of a new lesion. Data from participants who did not relapse were censored on the day of their last tumor assessment.|Time of first response (CR or PR) to disease progression, initiation of other (or additional) antitumor therapy, or death due to any cause (up to 34 months)|Participants who received any quantity of ramucirumab and had confirmed complete response or partial response. The number of participants censored was 1.||months||95% Confidence Interval|Median
745432|NCT00515697|Secondary|Percentage of Participants With Objective Response (Objective Response Rate) at 12 Weeks|The percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR) at Week 12, as classified according to Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. CR is the disappearance of all target and non-target lesions and the normalization of tumor marker levels. PR is having at least a 30% decrease in the sum of the longest diameter of target lesions without new lesions and progression of non-target lesions. The percentage of participants with objective response=(number of participants whose best overall response achieved at 12 weeks was CR or PR/number of participants treated)*100.|Week 12 [Cycle 6 (1 cycle=14 days)]|Intent-to-treat population: participants who received any quantity of ramucirumab.||percentage of participants||95% Confidence Interval|Number
745433|NCT00515697|Secondary|Percentage of Participants Showing Disease Control at Week 12|Participants who were alive and did not experience disease progression were considered to have disease control at 12 weeks. Disease control was based on lack of disease progression using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. According to RECIST criteria, disease progression was having at least a 20% increase in the sum of the longest diameter of target lesions and/or unequivocal progression of non-target lesion and/or detection of new lesion. Participants whose disease progression was symptomatic were not considered to have disease control. The percentage of participants showing disease control=(number of participants who did not have disease or symptomatic progression at Week 12/number of participants treated)*100.|Week 12 [Cycle 6 (1 cycle=14 days)]|Intent-to-treat population: participants who received any quantity of ramucirumab.||percentage of participants||95% Confidence Interval|Number
745434|NCT00515697|Secondary|Progression-Free Survival|Progression-free survival (PFS) is measured from the date of the first dose to the first documented date of disease progression as classified according to Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria or death from any cause. Disease progression is having at least a 20% increase in the sum of the longest diameter of target lesions and/or unequivocal progression of a non-target lesion and/or detection of a new lesion. Data for participants whose disease does not progress or for whom no post-baseline assessment is made are censored at the day of their last tumor assessment. Data for participants whose disease does not progress who are subsequently lost to follow-up are also censored at the day of their last tumor assessment.|First dose to measured progressive disease or death due to any cause (up to 34 months)|Intent-to-treat population: participants who received any quantity of ramucirumab. The number of participants censored was 4.||months||95% Confidence Interval|Median
745435|NCT00515697|Primary|Percentage of Participants With Objective Response (Objective Response Rate)|The percentage of participants with a best overall response of confirmed complete response (CR) or partial response (PR) as classified according to Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. CR is the disappearance of all target and non-target lesions and normalization of tumor marker levels. PR is having at least a 30% decrease in the sum of the longest diameter of target lesions without new lesions and progression of non-target lesions. The percentage of participants with objective response=(number of participants whose best overall response during therapy is CR or PR/number of participants treated)*100.|First dose to date of objective progressive disease or death due to any cause (up to 34 months)|Intent-to-treat population: participants who received any quantity of ramucirumab.||percentage of participants||95% Confidence Interval|Number
745436|NCT00515827|Secondary|Number of Participants Who Discontinued Study Drug|Participants who discontinued randomized study treatment for any reason|From first day of treatment to week 12|All 53 participants||Participant|||Number
745457|NCT00516074|Secondary|Change in Nighttime (2400-0600) Heart Rate From Baseline to Endpoint|Change from baseline to endpoint in nighttime (2400-0600) heart rate as measured by an ambulatory blood pressure monitor|12 weeks|Intent to treat; Last observation carried forward||beats per minute||Standard Error|Least Squares Mean
745437|NCT00515827|Secondary|Number of Participants Who Experienced Study Related Grade 2 or Higher Signs/Symptoms, Grade 3 or Higher Laboratory Abnormalities and Clinical Events From Week 12 to Week 24|Participant who experienced at least one study related grade 2 or higher signs/symptoms, grade 3 or higher laboratory abnormalities and clinical events that are 'possibly', probably', or definitely' related to study treatment. DAIDS Toxicity Grading Table (2004) was used for grading.|From week 12 to week 24|||participants|||Number
745438|NCT00515827|Secondary|Number of Participants Who Experienced Study Related Grade 2 or Higher Signs/Symptoms, Grade 3 or Higher Laboratory Abnormalities and Clinical Events From First Day of Treatment to Week 12|"Participant who experienced at least one study related grade 2 or higher signs/symptoms, grade 3 or higher laboratory abnormalities and clinical events that are possibly, probably or definitely related to study treatment. DAIDS Toxicity Grading Table (2004) was used for grading."|From first day of treatment to week 12|All participants on study treatment||Participant|||Number
745439|NCT00515827|Secondary|Change in CD8+/CD38+/HLA-DR+ Percent|Level of CD8+ T-cell activation was determined by measuring the percentage of cells that expressed both the activation marker CD38 and Human leukocyte antigen (HLA)-DR. Levels measured at pre-entry and entry were averaged. Change from baseline to week 12 was defined as CD8+/CD38+/HLA-DR+% at week 12 minus CD8+/CD38+/HLA-DR+% at baseline.|At pre-entry, entry, and week 12|All participants who stayed on study treatment and had not experienced virologic failures.||% CD8 cells co-express CD38+ and HLA-DR+||Inter-Quartile Range|Median
745440|NCT00515827|Secondary|Change in CD4+/CD38+/HLA-DR+ Percent|Level of CD4+ T-cell activation was determined by measuring the percentage of cells that expressed both the activation marker CD38 and Human leukocyte antigen (HLA)-DR. Levels measured at pre-entry and entry were averaged. Change from baseline to week 12 was defined as CD4+/CD38+/HLA-DR+% at week 12 minus CD4+/CD38+/HLA-DR+% at baseline.|At pre-entry, entry, and week 12|All participants who were on study treatment and had not experienced virologic failure||% CD4 cells co-express CD38+ and HLA-DR+||Inter-Quartile Range|Median
745441|NCT00515827|Secondary|Change in Total CD8 Cell Count|CD8 cell counts were assessed by flow cytometry at pre-entry and entry (the baseline value was the average of the two measurements) and at week 12|At pre-entry, entry, and week 12|All participants who were on study treatment and had not experienced virologic failure||cells/mm^3||Inter-Quartile Range|Median
745442|NCT00515827|Secondary|Change in Total CD4 Cell Count|CD4 cell counts were assessed by flow cytometry at pre-entry and entry (the baseline value was the average of the two measurements) and at week 12|At pre-entry, entry, and week 12|All participants who were on study treatment and had not experienced virologic failure||cells/mm^3||Inter-Quartile Range|Median
745443|NCT00515827|Secondary|Change in HIV-1 RNA Level|Change in HIV-1 RNA level, as measured by single copy assay, from baseline to weeks 10/12 . When averaging the measurements at pre-entry and entry, and at weeks 10 and 12, measurements below the lower limit of quantification (LLQ) were imputed a value of the LLQ divided by 2.|At pre-entry, entry, weeks 10 and 12|All participants who were on study treatment and had not experienced virologic failure||copies/mL||Inter-Quartile Range|Median
745444|NCT00515827|Primary|HIV-1 RNA Level|HIV-1 RNA level, as measured by single copy assay, averaged at weeks 10 and 12. The quantification limit of single copy assay was determined by the volume of plasma tested. When averaging the week 10 and 12 measurements, if one of both measurements were below the single copy assay lower limits, the lower limit of quantification was used to compute the average and the result was treated as below the averaged value.|At Weeks 10 and 12|49 subjects who were on study treatment before week 10 and did not experience virologic failure by week 12||copies/mL||Inter-Quartile Range|Median
745445|NCT00515879|Secondary|Range of Impaired Functioning Tool||Measured at Months 3, 6, and 9 post-treatment||||||
745446|NCT00515879|Secondary|Liebowitz Self-Rated Disability Scale||Measured at Months 3, 6, and 9 post-treatment||||||
745447|NCT00515879|Secondary|Quality of Life Enjoyment and Satisfaction Questionnaire||Measured at Months 3, 6, and 9 post-treatment||||||
745448|NCT00515879|Secondary|Social Phobia and Anxiety Inventory||Measured at Months 3, 6, and 9 post-treatment||||||
745449|NCT00515879|Primary|Liebowitz Social Anxiety Scale (LSAS)|The Liebowitz Social Anxiety Scale (LSAS; Liebowitz, 1987) is a 24-item scale that provides separate scores for fear and avoidance in social and performance situations; it is widely used in treatment studies of SAD. Total scores range from 0 (no anxiety) to 144 (maximum).|Measured at Months 3|||LSAS scores||95% Confidence Interval|Mean
745450|NCT00515879|Primary|Social Phobic Disorders Severity and Change Form|Social Phobic Disorders Severity and Change Form (SPD-SC Form; Liebowitz et al., 1992) is an expansion and adaptation of the Clinical Global Impression Scale (CGI) by Guy (1976) to SAD. Similar to the original CGI scale, the SPD-SC Form is rated by an independent evaluator on a 7-point scale to indicate severity (1=normal/not ill; 2 = minimally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most severely ill) and improvement (1=very much improved; 2=much improved; . 3=minimally improved' 4 = no change; 5=nimimal deterioration; 6=severe deterioration; 7=very severe deterioration). The primary outcome measure is units of a scale ranging from 1 (very much improved) to 7 (very severe deterioration).|Measured at Months 3 (immediately after treatment)|||Units on a scale||95% Confidence Interval|Mean
745451|NCT00516048|Primary|Incidence of Potentially Immune-related Treatment-emergent Adverse Events|Number of patients experiencing a potentially immune-related treatment-emergent adverse event at any point during the study|24 weeks|Intent to Treat||participants|||Number
745452|NCT00516048|Secondary|Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint|Change in HbA1c from baseline (Week 0) to endpoint (Week 24) by treatment-emergent antibody status|24 weeks|Intent to Treat; Last Observation Carried Forward||percent||Standard Deviation|Mean
745453|NCT00516048|Primary|Treatment-emergent Antibody Status (Maximum Titer Level Experienced)|Patients who experienced specified treatment-emergent antibody status at any point during the study (grouped by maximum titer level experienced)|24 weeks|Intent to Treat||Participants|||Number
745454|NCT00516074|Secondary|Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint|Change from baseline to endpoint in HbA1c|12 weeks|Intent to treat; Last observation carried forward||percent||Standard Error|Least Squares Mean
745455|NCT00516074|Secondary|Change in Mean 24 Hour Diastolic Blood Pressure From Baseline to Endpoint|Change from baseline to endpoint in average diastolic blood pressure measured over 24 hours by an ambulatory blood pressure monitor|12 weeks|Intent to treat; Last observation carried forward||mmHg||Standard Error|Least Squares Mean
745459|NCT00516074|Primary|Change in Mean 24-hour Heart Rate From Baseline to Endpoint|Change from baseline to endpoint in average heart rate measured over 24 hours by an ambulatory blood pressure monitor.|12 weeks|Intent to treat; Last observation carried forward||beats per minute||Standard Error|Least Squares Mean
745460|NCT00516139|Secondary|Absorption Rate (KA) for Participants in All Concomitant AED Groups Combined: Neutral, With EIAED, and With VPA|Individual serum LTG concentration data were subjected to population pharmacokinetic methodologies based on the concomitant AED groups. KA is defined as the rate at which a drug enters the body after administration. Serum LTG concentration-time data files incorporating, where appropriate, records of LTG administration, participant demography, and concomitant medication were supplied to CPDM by Clinical Data Management as NONMEM compatible .csv files.|Weeks 4, 7, 11, 15, 20, 24, and 28|Safety Population. Participants with missing data were not analyzed. Not all participants received all doses at each blood draw; therefore, participants were only analyzed for the dose received at blood draw.||1/h||95% Confidence Interval|Mean
745461|NCT00516139|Secondary|Apparent Volume of Distribution (V/F) for Participants in All Concomitant AED Groups Combined: Neutral, With EIAED, and With VPA|Individual serum LTG concentration data were subjected to population pharmacokinetic methodologies based on the concomitant AED groups. V/F is defined as the apparent volume in which a drug is distributed immediately after it has been injected intravenously and equilibrated between plasma and the surrounding tissues. Serum LTG concentration-time data files incorporating, where appropriate, records of LTG administration, participant demography, and concomitant medication were supplied to CPDM by Clinical Data Management as NONMEM compatible .csv files.|Weeks 4, 7, 11, 15, 20, 24, and 28|Safety Population. Participants with missing data were not analyzed. Not all participants received all doses at each blood draw; therefore, participants were only analyzed for the dose received at blood draw.||liters||95% Confidence Interval|Mean
745462|NCT00516139|Secondary|Apparent Clearance (CL/F) Based on the Concomitant AED Groups: Neutral, With EIAED, and With VPA|Individual serum LTG concentration data were subjected to population pharmacokinetic methodologies based on the concomitant AED groups. Clearance is defined as the volume of LTG per unit time eliminated from serum. Serum LTG concentration-time data files incorporating, where appropriate, records of LTG administration, participant demography, and concomitant medication were supplied to Clinical Pharmacokinetics Modelling and Simulation, Clinical Pharmacology, and Discovery Medicine (CPDM) by Clinical Data Management as NONMEM compatible .csv files.|Weeks 4, 7, 11, 15, 20, 24, and 28|Safety Population. Participants with missing data were not analyzed. Not all participants received all doses at each blood draw; therefore, participants were only analyzed for the dose received at blood draw.||Liters per hour||95% Confidence Interval|Mean
745463|NCT00516139|Secondary|Serum LTG Concentrations at Different LTG Doses Based on the Concomitant AED Groups: Neutral (Without Known Enzyme-inducing AED [EIAED], Valproate [VPA]) With EIAED, and With VPA|The blood samples were collected at the specified study visits; however, serum LTG concentrations were summarized by dose regimen, not by study week. The serum was assayed for LTG using an approved method under the management of Worldwide Bioanalysis, GlaxoSmithKline.|Weeks 4, 7, 11, 15, 20, 24, and 28|Safety Population. Participants with missing data were not analyzed. Not all participants received all doses at each blood draw; therefore, participants were only analyzed for the dose received at blood draw.||Micrograms per milliliter|serum concentrations|Full Range|Median
745464|NCT00516139|Secondary|Change From Baseline in Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Glucose, Potassium, Sodium, Triglycerides, and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points|The blood samples collected at the study visits were analyzed and assessed at the central laboratory, and the investigator reviewed and assessed the clinical significance. Change from Baseline was calculated by subtracting the value of cholesterol, HDL cholesterol, LDL cholesterol, glucose, potassium, sodium, triglycerides, and urea/BUN at the indicated time points in the study from the Baseline value.|Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD)|Safety Population. Only those participants with both a baseline and post-baseline value were analyzed.||millimoles (mmol) per liter||Full Range|Median
745465|NCT00516139|Secondary|Change From Baseline in Direct Bilirubin (DB), Total Bilirubin (TB), and Creatinine at the Indicated Time Points in the Study|The blood samples collected at the study visits were analyzed and assessed at the central laboratory, and the investigator reviewed and assessed the clinical significance. Change from Baseline was calculated by subtracting the value of DB, TB, and creatinine at the indicated time points in the study from the Baseline value.|Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD)|Safety Population. Only those participants with both a baseline and post-baseline value were analyzed.||micromoles (µmol) per liter||Full Range|Median
745466|NCT00516139|Secondary|Change From Baseline in Alkaline Phosphatase (Alk P), Alanine Amino Transferase (Ala AT), and Aspartate Amino Transferase (Asp AT) at the Indicated Time Points in the Study|The blood samples collected at the study visits were analyzed and assessed at the central laboratory, and the investigator reviewed and assessed the clinical significance. Change from Baseline was calculated by subtracting the value of Alk P, Ala AT, and Asp AT at the indicated time points in the study from the Baseline value.|Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD)|Safety Population. Only those participants with both a baseline and post-baseline value were analyzed.||International units per liter||Full Range|Median
745467|NCT00516139|Secondary|Change From Baseline in Red Blood Cell (RBC) Count at the Indicated Time Points in the Study|The blood samples collected at the study visits were analyzed and assessed at the central laboratory, and the investigator reviewed and assessed the clinical significance. Change from Baseline was calculated by subtracting the value of RBC count at the indicated time points in the study from the Baseline value. Change from baseline is measured as the number of red blood cells x 10^12 per liter.|Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD)|Safety Population. Only those participants with both a baseline and post-baseline value were analyzed.||Tera (10^12) cells per liter||Full Range|Median
745478|NCT00516139|Secondary|Number of Seizure-free Participants at Baseline Who Remained Seizure-free Throughout the Entire Treatment Period|Participants were considered to be seizure-free if they did not report any seizures at Baseline.|Week 30 or 33|Safety Population. Participants who were seizure-free at Baseline were analyzed.||participants|||Number
749184|NCT00541658|Secondary|Percent Change From Baseline Urine Type-I Collagen N-telopeptide/ Creatinine (NTX/Cr), Week 13, ITT Population||Week 13|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
745468|NCT00516139|Secondary|Change From Baseline in Mean Corpuscle Volume (MCV) at the Indicated Time Points in the the Study|The blood samples collected at the study visits were analyzed and assessed at the central laboratory, and the investigator reviewed and assessed the clinical significance. Change from Baseline was calculated by subtracting the value of MCV at the indicated time points in the study from the Baseline value.|Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD)|Safety Population. Only those participants with both a baseline and post-baseline value were analyzed.||Femtoliters||Full Range|Median
745469|NCT00516139|Secondary|Change From Baseline in Mean Corpuscle Hemoglobin (MCH) at the Indicated Time Points in the Study|The blood samples collected at the study visits were analyzed and assessed at the central laboratory, and the investigator reviewed and assessed the clinical significance. Change from Baseline was calculated by subtracting the value of MCH at the indicated time points in the study from the Baseline value.|Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD)|Safety Population. Only those participants with both a baseline and post-baseline value were analyzed.||picograms||Full Range|Median
745470|NCT00516139|Secondary|Change From Baseline in the Mean Corpuscle Hemoglobin Concentration (MCHC), Albumin, and Total Protein at the Indicated Time Points in the Study|The blood samples collected at the study visits were analyzed and assessed at the central laboratory, and the investigator reviewed and assessed the clinical significance. Change from Baseline was calculated by subtracting the values of MCHC, albumin, and total protein at the indicated time points in the study from the respective Baseline values.|Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD)|Safety Population. Only those participants with both a baseline and post-baseline value were analyzed.||grams per liter||Full Range|Median
745471|NCT00516139|Secondary|Percent Change From Baseline in the Basophil, Eosinophil, Hemoglobin, Lymphocyte, Monocyte, Absolute Neutrophil Count, Platelet Count, and White Blood Cell Count at the Indicated Time Points in the Study|The blood samples collected at the study visits were analyzed and assessed at the central laboratory, and the investigator reviewed and assessed the clinical significance. Percent change from Baseline = (value at each indicated time point in the study minus respective Baseline value divided by Baseline value) x 100.|Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD)|Safety Population. Only those participants with both a baseline and post-baseline value were analyzed.||Percent change in counts||Full Range|Median
745472|NCT00516139|Secondary|Change From Baseline in the Basophil, Eosinophil, Hemoglobin, Lymphocyte, Monocyte, Absolute Neutrophil Count (ANC), Platelet Count, and White Blood Cell (WBC) Count at the Indicated Time Points in the Study|The blood samples collected at the study visits were analyzed and assessed at the central laboratory, and the investigator reviewed and assessed the clinical significance. Change from Baseline was calculated by subtracting the value of basophil, eosinophil, hemoglobin, lymphocyte, monocyte, ANC, platelet count, and WBC count at the indicated time points in the study from the Baseline value.|Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD)|Safety Population. Only those participants with both a baseline and post-baseline value were analyzed.||Giga (10^9) cells per liter||Full Range|Median
745473|NCT00516139|Secondary|Change From Baseline in the Weight at the Indicated Time Points in the Study|Change from Baseline was calculated by subtracting the value of weight measured by the investigator at the indicated time points in the study from the Baseline value.|Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), Week 28 (WD), and Week 30/33 (End of study [EOS])|Safety Population. Only those participants with both a baseline and post-baseline value were analyzed.||kilograms||Standard Deviation|Mean
745474|NCT00516139|Secondary|Change From Baseline in the Height at the Indicated Time Points in the Study|Change from Baseline was calculated by subtracting the value of height measured by the investigator at the indicated time points in the study from the Baseline value.|Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), Week 28 (WD), and Week 30/33 (End of study [EOS])|Safety Population. Only those participants with both a baseline and post-baseline value were analyzed.||centimeters||Standard Deviation|Mean
745475|NCT00516139|Secondary|Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at the Indicated Time Points in the Study|Change from Baseline was calculated by subtracting the values of systolic and diastolic blood pressures recorded by the investigator at the indicated time points in the study from the respective Baseline values.|Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), Week 28 (WD), and Week 30/33 (End of study [EOS])|Safety Population. Only those participants with both a baseline and post-baseline value were analyzed.||Millimeters of mercury||Standard Deviation|Mean
745476|NCT00516139|Secondary|Number of Participants With Changes From Baseline in Overall Clinical Status in the Indicated Categories, as Measured by the IGE Scale|Investigators rated the participants' overall clinical status at Weeks 15 and 28 of the study treatment by using the IGE scale, comprised of 7 categories: 3 for improvement (mild improvement, moderate improvement, and marked improvement), 3 for deterioration (marked deterioration, moderate deterioration, mild deterioration), and 1 for no change. Investigators assessed the degree of the participants' improvement or deterioration or determined whether the participants’ condition had not changed compared to their Baseline condition.|Week 15 (Adjunctive Maintenance [Adj M] Phase), Week 28 (Adjunctive Optimization [Adj O] Phase), Week 28 (Monotherapy [Mono] Phase), and Week 28 (Early Withdrawal [WD])|Safety Population. Participants with missing data were not analyzed.||participants|||Number
745477|NCT00516139|Secondary|Number of Participants With Changes From Baseline in Seizure Severity in the Indicated Categories, as Measured by the Investigator's Global Evaluation (IGE) Scale|Investigators rated the participants' seizure severity at Weeks 15 and 28 of the study treatment by using the IGE scale, comprised of 7 categories: 3 for improvement (mild improvement, moderate improvement, and marked improvement), 3 for deterioration (marked deterioration, moderate deterioration, mild deterioration), and 1 for no change. Investigators assessed the degree of the participants' improvement or deterioration or determined whether the participants’ condition had not changed compared to their Baseline condition.|Week 15 (Adjunctive Maintenance [Adj M] Phase), Week 28 (Adjunctive Optimization [Adj O] Phase), Week 28 (Monotherapy [Mono] Phase), and Week 28 (Early Withdrawal [WD])|Safety Population. Only those participants who had seizures at baseline were analyzed.||participants|||Number
752319|NCT00558272|Secondary|N-desmethyl Metabolite of Saracatinib: AUCss Metabolite to Parent Ratio||Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29|||Ratio||Full Range|Median
745479|NCT00516139|Secondary|Number of Participants With the Indicated Change From Baseline in Weekly Seizure Frequency During Each Phase of the Study|Participants recorded the number of seizures, by seizure type, as well as the duration of episodes of innumerable seizure activity in their daily diaries during all phases of the study. For participants who withdrew from the study, seizure data were averaged for the portion of the study the participant completed up to the time of study drug discontinuation. Participants who experienced a change from Baseline in the weekly seizure frequency were categorized as having a >=25%, >=50%, >=75%, or 100% reduction or a >=50% increase in percent change from Baseline in weekly seizure frequency.|Baseline (Week 0), Dose-Escalation Phase (Week 7), Maintenance Phase (Week 15), Adjunctive Optimization (Adj O) Phase (Week 28), Conversion Phase (Week 20), Monotherapy Phase (Week 28), and end of treatment (ET, Week 30 or 33)|Safety Population. Only those participants who had seizures at baseline were analyzed.||participants|||Number
745480|NCT00516139|Secondary|Percent Change From Baseline (BL) in Weekly Seizure (sz.) Frequency for All Partial Seizures During Each Phase of the Study|Partial-onset sz. have a focal site of onset; sz. activity is initially limited to 1 brain hemisphere. Partial sz. can remain simple or complex, or evolve to generalized tonic-clonic sz. Participants (par.) recorded the number of sz., by type as well as the episode duration of innumerable sz. activity), in daily diaries. If par. withdrew from study, data were averaged for the study portion the par. completed up to the time of drug discontinuation. Percent change from BL = (BL value minus study phase value divided by BL value) x 100; positive values indicate reduction from BL in sz. frequency.|Baseline (Week 0), Dose-Escalation Phase (Week 7), Maintenance Phase (Week 15), Adjunctive Optimization Phase (Week 28), Conversion Phase (Week 20), Monotherapy Phase (Week 28), and end of treatment (Week 30 or 33)|Safety Population. Only those participants who had seizures at baseline were analyzed.||Percent change in seizure frequency||Full Range|Median
745481|NCT00516139|Primary|Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event|An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or causes its prolongation, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. A complete list of all SAEs and AEs experienced in the study can be found in the SAE/AE section.|From Baseline (Week 0) until 3 weeks after the end of treatment (Week 30 or 33)|Safety Population: all participants who were enrolled and took at least one dose of study drug||participants|||Number
745482|NCT00516165|Secondary|Overall Survival|The median overall survival was 8.4 months (95% CI, 3.9-21.1 months). Only 2 ((8 %) patients were progression-free at 24 weeks. The study did not proceed to the second stage of the phase 2 portion of the study.|2 years|||months||95% Confidence Interval|Median
745483|NCT00516165|Secondary|Time to Progression|3.9 months with a CI of 21-|2 years|||month||95% Confidence Interval|Median
745484|NCT00516165|Secondary|Overall Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|2 years|||percentage of patient response||95% Confidence Interval|Number
745485|NCT00516165|Secondary|Number of Patients With Adverse Events Who Were Treated With RAD001 for Advanced HCC|Everolimus given at 10 mg/day as a single agent was well tolerated in patients with advanced HCC.|2 years|Patients with histologically confirmed measurable advanced HCC. The primary end points were determination of a safe dosage of everolimus and progression-free survival at 24 weeks.||Participants|||Count of Participants
745486|NCT00516165|Primary|Progression-free Survival Rate at 24 Weeks|"Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
This information will be collected during two years of patient participation."|2 years|||months||95% Confidence Interval|Median
745487|NCT00516165|Primary|Maximum Tolerated Dose of RAD001 in Patients With Advanced Hepatocellular Carcinoma (HCC).||2 years|Patients with histologically confirmed measurable advanced Hepatocellular Carcinoma.||mg|||Number
745488|NCT00516217|Secondary|6 Month Progression Free Survival Rate|"Percentage of patients who were progression free at 6 months. The 6-month progression free rate was estimated using the Kaplan Meier method.
Relapse was assessed by investigator according to Revised Response Criteria for Malignant Lymphoma. Progression required a appearance of any new lesion > 1.5 cm, at least 50% increase from nadir in the sum of products of involved nodes, or a 50% increase in the longest diameter of any single node."|6 months|||percentage of participants||95% Confidence Interval|Number
745489|NCT00516217|Secondary|12 Month Overall Survival Rate|Percentage of patients who were alive at 12 months. The 12-month survival rate was estimated using the Kaplan Meier method.|12 months|||percentage of participants||95% Confidence Interval|Number
745490|NCT00516217|Primary|Overall Response|"Overall response is defined as achievement of a complete response (CR) or partial response (PR) as defined by the Revised Response Criteria for Malignant Lymphoma.
CR: complete disappearance of all detectable disease PR: >=50% decrease in the sum of the product of diameters of indicator lesions."|Duration of treatment (up to 10 years)|||participants|||Number
745491|NCT00516269|Primary|Mean Difference Between Post-Methylphenidate and Post-Placebo Measurement|"The primary endpoint is the “fatigue worst” score (range: 0 – 10) on the Brief Fatigue Inventory (BFI) at the end of two-week treatment (either Methylphenidate or placebo). Worst fatigue is defined as participants' rating of worst fatigue on a scale of 0 (no fatigue) to 10 (as bad as can imagine). Since each participant is expected to receive both 2-week of Methylphenidate or 2-week placebo at different times, they serve as their own control. The outcome is the difference in “fatigue worst” score between post-Methylphenidate measurement and post-Placebo measurement."|At end of two 2-week treatment cycles (4 weeks total)|It is a crossover design and only the 33 patients who completed the study were included in the final data analysis.||units on a scale||Standard Deviation|Mean
745510|NCT00516321|Secondary|Number of Participants With Rapid Virological Response (RVR) and Extended RVR (eRVR) During the DB Phase|RVR is defined as the absence of detectable HCV RNA after 4 weeks of antiviral treatment. eRVR is defined as the absence of detectable HCV RNA after 4 weeks of antiviral treatment that persisted through Week 12.|From Baseline up to Week 12|ITT Population||participants|||Number
745492|NCT00516295|Primary|Time to Disease Progression in Patients Receiving VTC With or Without Bevacizumab|Time from enrollment to disease progression, death, second malignant neoplasm, or last patient follow-up whichever occurs first. Patients who experience disease progression, death or second malignant neoplasm will be considered to have experienced an event; otherwise the patient will be considered censored at last follow-up.|Maximum of 5 years after enrollment|Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.||days of event free survival||95% Confidence Interval|Median
745493|NCT00516295|Primary|The Occurrence of Limiting Toxicity in an Eligible and Evaluable Patient.|Limiting toxicity defined as Any Grade IV hematological toxicities lasting longer than 7 days, myelosuppression causing delays > 14 days in delivery of therapy, > Grade 3 thromboembolic events, > Grade 3 bleeding events, > Grade 2 hypertension, > Grade 2 proteinuria.|First 2 courses (42 days) of therapy|Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.||number of toxicities|||Number
745494|NCT00516321|Secondary|Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase|The BMI for participants was calculated at the indicated time points as body weight in kilograms divided by height in meters squared. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.|DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)|Safety DB Population. Only those participants contributing data at the indicated time points were analyzed.||Kilograms per meters squared (kg/m^2)||Standard Deviation|Mean
745495|NCT00516321|Secondary|Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase|The weight of participants was recorded at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.|DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)|Safety DB Population. Only those participants contributing data at the indicated time points were analyzed.||Kilograms (kg)||Standard Deviation|Mean
745496|NCT00516321|Secondary|Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase|Heart rate was measured in participants at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.|DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)|Safety DB Population. Only those participants contributing data at the indicated time points were analyzed.||beats per minute||Standard Deviation|Mean
745497|NCT00516321|Secondary|Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase|Participant’s blood pressure was measured at the indicated time points during the study. Systolic blood pressure is a measure of blood pressure while the heart is beating. Diastolic blood pressure is a measure of blood pressure while the heart is relaxed. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.|DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)|Safety DB Population. Only those participants contributing data at the indicated time points were analyzed.||Millimeters of mercury (mmHg)||Standard Deviation|Mean
745498|NCT00516321|Secondary|Number of Participants With CS and NCS Change From Baseline for 12-lead ECG at the Indicated Time Points During the DB Phase|"Duplicate 12-lead ECGs were required at Screening/BL, Antiviral BL, and at 12 weekly intervals during the study. The number of participants with a CS or a NCS change from baseline in ECG status was reported, as determined by the Investigator based on a reasonable standard of clinical judgment. Not applicable indicates that information was not provided by the investigator on whether the change from baseline ECG was CS or NCS."|End of Treatment (up to Week 52); and 24-week FU (up to Week 72)|Safety DB Population. Only those participants contributing data at the indicated time points were analyzed.||participants|||Number
745499|NCT00516321|Secondary|Number of Participants Assessed as Normal and Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points During the DB Phase|"Duplicate 12-lead ECGs were required at Screening/BL, Antiviral BL, and at 12 weekly intervals during the study. The investigator assigned an ECG status of normal, abnormal, CS, or NCS; a status of abnormal alone indicates that the investigator did not determine if ECG was CS or NCS. Normal, all ECG parameters within accepted normal ranges. Abnormal, ECG finding(s) outside of normal ranges. CS, ECG with a CS abnormality that meets exclusion criteria. NCS, ECG with an abnormality not CS or meeting exclusion criteria, per Investigator, based on reasonable standards of clinical judgment."|DB Phase: Antiviral BL (up to Week 10); End of Treatment (up to Week 52); and 24-week FU (up to Week 72)|Safety DB Population. Only those participants contributing data at the indicated time points were analyzed. Worst ECG post-BL is the worst ECG assessment reported for a participant at a post-BL assessment and could be Normal, Abnormal - NCS, Abnormal - CS, or Abnormal (NCS or CS not given).||participants|||Number
745500|NCT00516321|Secondary|Number of Participants in the Indicated Categories for Cataract Event During the DB Phase, Per Clinical Events Committee (CEC) Adjudication During the DB Phase|Ophthalmic (pertaining to eye) assessments were performed during the study. A cataract event is defined as an event ascertained to be a cataract (opacity or cloudiness of the lens of the eye, causing impairment of vision) by at least one of the CEC members (comprised of expert ophthalmologists who provided objective medical review of the blinded ophthalmic data). Per the CEC, cataract events were categorized as: (1) Cataract Progression (CP; progression of cataracts present at BL); and (2) Incident Cataract (IC; development of new cataracts). One eye=unilateral; both eyes=bilateral.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|Safety DB Population||participants|||Number
745511|NCT00516321|Secondary|Number of Participants in the Indicated Categories for Minimum Platelet Count With Antiviral Therapy During the DB Phase|The minimum platelet count with antiviral therapy was categorized as follows: <25 Gi/L; >=25 to <50 Gi/L; >=50 to <90 Gi/L; >=90 to <150 Gi/L; >=150 Gi/L to <200 Gi/L; >=200 Gi/L to <400 Gi/L; and >=400 Gi/L.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|ITT Population||participants|||Number
745501|NCT00516321|Secondary|Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS During the DB Phase|Blood samples for the assessment of hematology parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL during the DB Phase are reported, per severity grades by DAIDS, for levels of hemoglobin (low=anemia), lymphocytes (low=lymphocytopenia), total neutrophils (low=neutropenia), and white blood cells (low=leukocytopenia). Per the DAIDS toxicity table, grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|Safety DB Population||participants|||Number
745502|NCT00516321|Secondary|Number of Par. With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) During the DB Phase|Blood samples for the assessment of clinical chemistry parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL during the DB Phase are reported, per severity grades by DAIDS, for levels of calcium (low=hypocalcemia; high=hypercalcemia), glu. (low=hypoglycemia; high=hyperglycemia), pot. (low=hypokalemia; high=hyperkalemia), and sod. (low=hyponatremia; high=hypernatremia). Per the DAIDS toxicity table, the grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|Safety DB Population: all randomized participants who had received study drug in the DB Phase||participants|||Number
745503|NCT00516321|Secondary|Number of Participants (Par.) Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) During the DB Phase|There are two genetic variants (rs12979860 and rs8099917) mapping near IL28B associated with both interferon-induced SVR and spontaneous HCV clearance. Genotyping of the IL28B polymorphisms (rs12979860 and rs8099917) was conducted. IL28B genotype distribution by response to antiviral therapy (SVR and RVR) for both treatment arms was assessed. The effect of genotype was tested by comparing participants that carried 2 copies of the IL28B favorable response allele versus the others (recessive model). Genotypes at rs12979860 were coded as: CC=1, CT or TT=0; rs8099917 was coded as TT=1, GT or GG=0.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|Pharmacogenetic (PGx) Sub-Population: participants enrolled in this study who provided written informed consent for PGx research with a blood sample for genotyping and who were successfully genotyped for at least one of the two genetic markers under study||participants|||Number
745504|NCT00516321|Secondary|Number of Participants Who Prematurely Discontinued Antiviral Therapy in the DB Phase|The following participants were considered to have discontinued from antiviral therapy: participants who were lost to follow-up; participants who withdrew for any reason; participants who died; participants who otherwise did not complete their planned course of antiviral therapy for any reason. The planned duration of antiviral therapy was 48 weeks for participants with Non-Genotype 2/3 and 24 or 48 weeks for participants with Genotype 2/3.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|ITT Population||participants|||Number
745505|NCT00516321|Secondary|Number of Participants With the Indicated Levels of Peginterferon Dose Reductions in the DB Phase|The assigned dose in the DB Phase of peginterferon alfa-2a was 180 micrograms (mcg). For peginterferon dose modification, downward adjustments in one level increments was considered. The lowest dose of peginterferon alfa-2a that was allowed to be administered was 45 mcg. Where dose adjustment was required for moderate to severe adverse reactions (clinical and/or laboratory), an initial dose reduction to 135 mcg was generally adequate. In some cases, a dose reduction to 90 mcg or 45mcg was necessary. Dose increases toward the original dose were considered when the adverse reaction was resolved.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|ITT Population. One participant could have had more than one dose reduction.||participants|||Number
745506|NCT00516321|Secondary|Time to First Dose Reduction of Peginterferon Alfa-2a and Ribavirin Therapy in the DB Phase|Time to first dose reduction was calculated as the time period from the first dose to the first dose reduction.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|ITT Population. Only those participants with dose reductions were analyzed.||weeks||Standard Deviation|Mean
745507|NCT00516321|Secondary|Number of Participants in the Indicated Categories for Antiviral Therapy Dose Reductions in the DB Phase|Participants were assigned a score equal to the number of times their dose of antiviral therapy (peginterferon or ribavirin) was reduced (0=no dose reductions [DRs]; 1=one DR; 2=two DRs; 3=three DRs; >3=more than three DRs). Where possible, every effort was made to maintain the recommended dose of antiviral therapy for the treatment duration in the DB Phase. However, where dose modification of antiviral therapy was required due to safety concerns, it was performed by the Investigator as per the region-specific product labels of peginterferon and ribavirin.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|ITT Population||participants|||Number
745508|NCT00516321|Secondary|Number of Participants With End of Treatment Response (ETR) and Sustained Virological Response at Week 12 of Follow-up (SVR12) During the DB Phase|ETR is defined as the absence of detectable HCV RNA at the end of antiviral treatment. SVR12 is defined as the absence of detectable HCV RNA at the end of antiviral treatment and the 12-week follow-up assessment.|From Baseline up to Week 36 or Week 60 (for participants with Genotype 2/3) or up to Week 60 (for participants with Non-Genotype 2/3)|ITT Population||participants|||Number
745509|NCT00516321|Secondary|Number of Participants With Early Virological Response (EVR) and Complete EVR (cEVR) During the DB Phase|EVR is defined as a clinically significant reduction from Baseline in HCV RNA (>=2 log10 decrease in HCV RNA or undetectable HCV RNA) after 12 weeks of antiviral treatment. cEVR, a subset of EVR, is defined exclusively as undetectable HCV RNA after 12 weeks of antiviral treatment.|From Baseline up to Week 12|ITT Population||participants|||Number
745594|NCT00517075|Secondary|Theory of Mind||At baseline and the end of each study phase (random and open)|P.I. has left the institution and NYSPI has no access to the data. Results will not be analyzed or presented.|||||
745512|NCT00516321|Secondary|Median Platelet Count at the Indicated Time Points During the DB Phase|Blood taken from peripheral blood vessels was used for the measurement of platelet counts.|DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)|ITT Population. Only those participants contributing data at the indicated time points were analyzed. The Last On Treatment assessment refers to the actual last treatment assessment, not necessarily to the End of Treatment assessment entered by the Investigator.||Gi/L||Full Range|Median
745513|NCT00516321|Secondary|Median Platelet Count at the Indicated Time Points During the OL Phase|Blood taken from peripheral blood vessels was used for the measurement of platelet counts. The Last On Treatment assessment refers to the actual last treatment assessment, not necessarily to the End of Treatment assessment entered by the Investigator.|OL Phase: Baseline; Day 1; Weeks 1, 2, 3, 4, 5, 6, 7, 8, and 9; Antiviral Baseline (up to Week 10); End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 62); 12-week FU (up to Week 70); and 24-week FU (up to Week 82)|Safety Population. Only those participants contributing data at the indicated time points were analyzed.||Gi/L||Full Range|Median
745514|NCT00516321|Secondary|Number of Participants Receiving the Indicated Doses of Eltrombopag in the OL Phase Who Initiated Antiviral Therapy (Peginterferon Alfa-2a and Ribavirin) in the DB Phase|In the OL Phase, participants initially received the lowest dose of eltrombopag (25 mg QD) for 2 weeks. If after this time the platelet count was <90 Gi/L, participants underwent sequential dose escalation to the next highest dose (50 mg QD for up to 2 weeks), with further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) if platelet counts remained <90 Gi/L. Participants who achieved platelet count >=90 Gi/L on any of the eltrombopag doses in the OL Phase initiated antiviral therapy in the DB Phase.|From Baseline up to Week 9 in the OL Phase|Safety Population. Participants with a platelet count >=90 Gi/L and who initiated antiviral therapy during the DB Phase were analyzed.||participants|||Number
745515|NCT00516321|Secondary|Number of Participants Whose Platelet Count Increased From a Baseline Count of <75 Gi/L to a Count Greater Than or Equal to (>=) 90 Giga (10^9) Cells Per Liter (Gi/L) During the Open-label (OL) Pre-Antiviral Treatment Phase|Participants were assessed for a shift from a baseline platelet count of <75 Gi/L to a count >=90 Gi/L during the OL Phase (up to 9 weeks). Local laboratories were used for platelet function tests. Platelet counts were measured by blood draw.|From Baseline up to Week 9 in the OL Phase|Safety Population: all participants who had received study drug in the OL Phase||participants|||Number
745516|NCT00516321|Primary|Number of Participants With Sustained Virologic Response (SVR) in the Double-blind (DB) Antiviral Treatment Phase|Participants with SVR were defined as those with undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) at 24 weeks post-completion of the treatment period of the DB Phase.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|Intent-to-Treat (ITT) Population: all participants randomized in the DB Phase||participants|||Number
745517|NCT00516386|Secondary|Change in Levels of N-terminal Propeptide of Type 1 Procollagen (P1NP) Following rhIGF-1 Administration in Girls With Anorexia Nervosa||Baseline and 7-10 days|||ng/ml||Standard Error|Mean
745518|NCT00516386|Primary|Change in Levels of Insulin Like Growth Factor-1 (IGF-I) Following Recombinant Human (rh) IGF-1 Administration in Girls With Anorexia Nervosa||Baseline and 7-10 days|16 subjects were screened for the study, and 10 completed the study. 10 were analyzed.||ng/ml||Standard Error|Mean
745519|NCT00516503|Secondary|Adverse Event Profile of Topical Amitriptyline HCl/ Baclofen/Ketamine > Frequency and Severity of Adverse Events Reported by the Patient in the > Symptom Experience Diary and Evaluated Through Clinical Assessment by NCI CTCAE v3.0|Frequency and severity of adverse events reported by patients in weekly diary and evaluated through clinical assessment by NCI CTCAE v3.0. The number of patients reporting grade 3 or higher events are reported in this outcome measure. For a full list of all events, please refer to the Adverse Events section of this report.|Up to 4 weeks|All patients that were assessed for adverse events are used in this analysis.||Participants|||Count of Participants
745520|NCT00516503|Secondary|Numbness, Tingling, and Pain as Measured by the Peripheral Neuropathy Questionnaire at Baseline and Weekly for 4 Weeks|The Peripheral Neuropathy Questionnaire was used to analyze this endpoint. Patient neuropathy symptoms were scored on a 0 - 100 scale (higher score represents less symptomatic). The area under the curve (AUC) from baseline to week 4 was calculated for each patient's score. The average AUC for the placebo arm and the topical amitriptyline HCl/ baclofen/ ketamine arm are reported.|Up to 4 weeks|||units on a scale * week||Standard Deviation|Mean
745521|NCT00516503|Secondary|Pain Severity and Interference as Measured by the Brief Pain Inventory (BPI) at Baseline and Week 4|Pain severity, defined by the four items addressing worst, least, and average pain and pain right now as measured by the BPI will be analyzed identical to the primary endpoint. Additionally, total pain interference as measured by the BPI will be transformed onto a 0-100 ( higher is less pain) point scale. The area under the curve (AUC) from baseline to week 4 was calculated for each patient's score. The average AUC for the placebo arm and the topical amitriptyline HCl/ baclofen/ ketamine arm are reported.|Up to 4 weeks|||units on a scale * week||Standard Deviation|Mean
745522|NCT00516503|Secondary|Mood States and Total Mood Disturbance as Measured by the Profile of Mood States (POMS)|Each mood scale (0 - 100, higher is better mood) will be analyzed as an endpoint along with the total mood disturbance score.|At 4 weeks|||units on a scale||Standard Deviation|Mean
745523|NCT00516503|Secondary|Autonomic Symptoms and Functioning as Measured by the EORTC QLQ-CIPN20 at Baseline and Week 4|The scoring algorithm for the parent instrument, the EORTC QLQ-C30, was applied for linearly converting items and subscales of CIPN-20 to 0–100 scales so that a high score corresponds to better condition or less symptom. The secondary analysis was to compare changes from baseline at 4 weeks for the autonomic neuropathy subscale of the CIPN-20. To analyze this endpoint, the area under the curve (AUC) from baseline to week 4 was calculated for each patient's motor neuropathy score. The average AUC for the placebo arm was compared to the average AUC for the topical amitriptyline HCl/ baclofen/ ketamine arm using a Wilcoxon rank sum test.|Up to 4 weeks|There were 26 participants in the BAK arm and 27 in the placebo arm who did not provide primary endpoint data. In the BAK arm, 11 refused due to experiencing an adverse event and 15 refused for non-specified reasons. In the placebo arm, eight refused due to an adverse event, one patient died, and 18 refused for non-specified reasons.||(units on a scale)*week||Standard Deviation|Mean
745524|NCT00516503|Secondary|Motor Neuropathy as Measured by the EORTC QLQ-CIPN20 at Baseline and Week 4|The scoring algorithm for the parent instrument, the EORTC QLQ-C30, was applied for linearly converting items and subscales of CIPN-20 to 0–100 scales so that a high score corresponds to better condition or less symptom. The secondary analysis was to compare changes from baseline at 4 weeks for the motor neuropathy subscale of the CIPN-20. To analyze this endpoint, the area under the curve (AUC) from baseline to week 4 was calculated for each patient's motor neuropathy score. The average AUC for the placebo arm was compared to the average AUC for the topical amitriptyline HCl/ baclofen/ ketamine arm using a Wilcoxon rank sum test.|From Baseline to week 4|There were 26 participants in the BAK arm and 27 in the placebo arm who did not provide primary endpoint data. In the BAK arm, 11 refused due to experiencing an adverse > event and 15 refused for non-specified reasons. In the placebo arm, eight refused due to an > adverse event, one patient died, and 18 refused for non-specified reasons.||(units on a scale)* week||Standard Deviation|Mean
745525|NCT00516503|Primary|Total Sensory Neuropathy as Measured by the European Organization for Research and Treatment of Cancer [EORTC] Quality of Life [QLQ] - Chemo-induced Peripheral Neuropathy [CIPN20]|The scoring algorithm for the parent instrument, the EORTC QLQ-C30, was applied for linearly converting items and subscales of CIPN-20 to 0–100 scales so that a high score corresponds to better condition or less symptom. The primary analysis was the change in sensory neuropathy subscale of the CIPN-20 from baseline to week 4. The area under the curve (AUC) from baseline to week 4 was calculated for each patient's sensory neuropathy score. The average AUC for the placebo arm was compared to the average AUC for the topical amitriptyline HCl/ baclofen/ ketamine arm using a Wilcoxon rank sum test.|From baseline to 4 weeks|There were 26 participants in the BAK arm and 27 in the placebo arm who did not provide primary endpoint data. In the BAK arm, 11 refused due to experiencing an adverse event and 15 refused for non-specified reasons. In the placebo arm, eight refused due to an adverse event, one patient died, and 18 refused for non-specified reasons.||(units on a scale) * week||Standard Deviation|Mean
745526|NCT00516737|Secondary|Number of Participants With Absence of Functional Disability at 2 Hours Post-Dose|"Level of functional disability was assessed on a paper diary by the participants.
Level of functional disability was rated as: normal, mildly impaired, severely impaired or unable to do activities, requires bed rest. Absence of functional disability defined as a rating of normal at 2 hours post-dose."|2 hours post-dose|The FAS population included all randomized participants who had at least one assessment within 2 hours post-dose (i.e., after baseline assessment).||Participants|||Number
745527|NCT00516737|Secondary|Number of Participants With Absence of Nausea at 2 Hours Post-dose|Absence or presence of nausea was recorded by the participants on a paper diary. Absence is defined as no nausea at 2 hours post-dose.|2 hours post-dose|The FAS population included all randomized participants who had at least one assessment within 2 hours post-dose (i.e., after baseline assessment).||Participants|||Number
745528|NCT00516737|Secondary|Number of Participants With Absence of Phonophobia at 2 Hours Post-dose|Absence or presence of phonophobia was recorded by the participants on a paper diary. Absence is defined as no phonophobia at 2 hours post-dose.|2 hours post-dose|The FAS population included all randomized participants who had at least one assessment within 2 hours post-dose (i.e., after baseline assessment).||Participants|||Number
745529|NCT00516737|Secondary|Number of Participants With Absence of Photophobia at 2 Hours Post-dose|Absence or presence of photophobia was recorded by the participants on a paper diary. Absence is defined as no photophobia at 2 hours post-dose.|2 hours post-dose|The FAS population included all randomized participants who had at least one assessment within 2 hours post-dose (i.e., after baseline assessment).||Participants|||Number
745530|NCT00516737|Secondary|Number of Participants With no Rescue Use up to 24 Hours Post-Dose|Participants recorded use of any rescue medication up to 24 hours after dosing with study medication on a paper diary.|24 hours post-dose|The FAS population included all randomized and treated participants.||Participants|||Number
745531|NCT00516737|Secondary|Number of Participants With 24-Hour Sustained Pain Freedom|24-hour sustained pain freedom (defined as pain freedom from 2 to 24 hours post-dose and no use of rescue medication). Participants assessed pain severity and use of rescue medication on a paper diary.|24 hours post-dose|The FAS population was used for this secondary variable of 24-hour sustained pain freedom, unless participants were otherwise identified as non-responders for this endpoint (i.e., took rescue up to 24 hours post-dose or were not pain free at 2 hours post-dose). To be included, participants must have also had a non-missing 24-hour assessment.||Participants|||Number
745532|NCT00516737|Primary|Number of Participants Who Are Pain Free at 2 Hours Post-Dose|Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), or 3 (severe). Pain free = rating of 0 (no pain) at 2 hours post-dose.|2 hours post-dose|Full Analysis Set (FAS): The FAS population includes all randomized participants who have at least one assessment within 2 hours post-dose (i.e., after baseline assessment).||Participants|||Number
745533|NCT00516893|Secondary|Annualized Relapse Rate|Annualized relapse rate was calculated as the total number of relapses that occurred during the study divided by the total number of years the participant was followed in the study. The annualized relapse rate was based only on those relapses that were determined to meet the definition of relapse per the investigator’s clinical judgment. New or recurrent symptoms that occurred less than 30 days following the onset of a protocol-defined relapse were considered part of the same relapse.|Through Week 36|Participants who received at least 1 dose of study drug.||relapses/participant-years|||Number
745534|NCT00516893|Secondary|Mean Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at Week 36|EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. The change in EDSS at Month 36 was calculated as EDSS at Month 36 minus EDSS at baseline.|Baseline, Week 36|Participants with EDSS scores at Baseline and Week 36 (includes participants who withdrew from the study).||scores on a scale||Standard Deviation|Mean
745595|NCT00517075|Secondary|Depression||At baseline, every 2 weeks during rTMS sessions, and at monthly follow-up visits.|P.I. has left the institution and NYSPI has no access to the data. Results will not be analyzed or presented.|||||
745596|NCT00517075|Secondary|Social Functioning||At baseline, every 2 weeks during rTMS sessions, and at monthly follow-up visits.|P.I. has left the institution and NYSPI has no access to the data. Results will not be analyzed or presented.|||||
752320|NCT00558272|Secondary|N-desmethyl Metabolite of Saracatinib: Minimum Plasma Concentration at Steady State (Css,Min)||Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29|||ng/ml||Full Range|Median
745535|NCT00516893|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs|AE: any sign, symptom, or diagnosis/disease that was unfavorable or unintended, new, or if pre-existing, worsened in a participant administered a study treatment and that did not necessarily have a causal relationship with this treatment. SAE: an event that resulted in death; an event that, in the view of the investigator, placed the participant at immediate risk of death (life-threatening event); an outcome that resulted in a congenital anomaly/birth defect diagnosed in a child of a participant in this study; an event that required or prolonged inpatient hospitalization; an event that resulted in persistent or significant disability/incapacity; any other medically important event that, in the opinion of the investigator, may have jeopardized the participant or may have required intervention to prevent one of the other outcomes listed above. Events were classified as ‘related’ or ‘not related’ to study drug, and categorized as ‘mild’ moderate’ or ‘severe’ per protocol.|AEs: collected from Baseline (Week 0) until Week 36 or premature withdrawal. SAEs: collected from informed consent until Week 36 or premature withdrawal.|Participants who received at least 1 dose of study drug.||participants|||Number
745536|NCT00516893|Primary|Number of Participants With Anti-Natalizumab Antibody Negative, Transient Positive, and Persistent Positive Status|Negative: no detectable antibody at all post-baseline visits. Persistent positive: antibody positive at 2 or more post-baseline visits at least 42 days apart, or positive at the last post-baseline visit. Transient positive: antibody positive at only 1 post-baseline visit prior to the last visit.|Assessed every 12 weeks from Week 0 (Baseline) to Week 36|Participants who received at least 1 dose of natalizumab, had a negative baseline antibody result, and had at least 1 antibody assessment after the first dose.||participants|||Number
745537|NCT00510224|Secondary|Pre Versus Post Treatment Mitogenic Effects.||12 Weeks|The trial was closed for futility after no PSA responses were observed among the first 13 patients, and this analysis was not performed|||||
745538|NCT00510224|Secondary|Grade 4-5 Adverse Events||12 weeks|||Adverse Events|||Number
745539|NCT00510224|Secondary|Pre-post Percent Change in Circulating Levels of IGF-1 and IGF-Binding Protein 1.|Serum was batched and IGF and IGFBP levels were assayed at one time at the end of the study using an enzyme-linked immunoabsorbent assay (ELISA) method by Diagnostic Systems Laboratories (Webster, TX).|Baseline, 12 weeks|||percent change||Full Range|Median
745540|NCT00510224|Primary|PSA Response|Number of participants with a PSA decline of at least 50% from Baseline during the first 3 cycles of therapy, confirmed by a second measurement at least 2 weeks later.|12 weeks|n=27 was determined to be sufficient to test for a 20% PSA response proportion compared with a null hypothesis of 5%. A two-stage design was employed to carry out an interim analysis for efficacy. As no patient showed a PSA decline among the first 13 accrued after 3 cycles (the first evaluation of PSA response), accrual was discontinued||Participants|||Number
745541|NCT00510276|Secondary|Strong Responders by Baseline Smoking Status|Baseline smoking status was recorded and associations to response to treatment were determined. Strong response was defined as 40% or greater decrease in ADHD symptoms as measured by the CAARS-Inv:SV total ADHD symptom score. The 18-item total CAARS-Inv:SV ADHD symptom score is the sum of the Inattention and Hyperactivity-Impulsivity subscales. Each item is scored on a 0 to 3 scale (0=not at all, never; 1=just a little, once in a while; 2=pretty much, often; 3=very much, very frequently). The scale assesses symptom severity over the past week. The total score ranges from 0 to 54.|12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||participants|||Number
745542|NCT00510276|Secondary|Responders by Baseline Smoking Status|Baseline smoking status was recorded and associations to response to treatment were determined. Response was defined as 25% or greater decrease in ADHD symptoms as measured by the CAARS-Inv:SV total ADHD symptom score. The 18-item total CAARS-Inv:SV ADHD symptom score is the sum of the Inattention and Hyperactivity-Impulsivity subscales. Each item is scored on a 0 to 3 scale (0=not at all, never; 1=just a little, once in a while; 2=pretty much, often; 3=very much, very frequently). The scale assesses symptom severity over the past week. The total score ranges from 0 to 54.|12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||participants|||Number
745543|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Epworth Sleepiness Scale (ESS)|Used to determine the level of daytime sleepiness. The ESS is a self-rated questionnaire with 8 items that describe normative daily situations known to vary in their soporific qualities. Subjects rate the likelihood of dozing off or falling asleep in each of these situations. Each item is rated on a 4-point scale from 0 (would never doze) to 3 (high chance of dozing). The item scores are summed to produce a total score (range of 0-24). Score >10 (95th percentile) are considered to be suggestive of significant daytime sleepiness.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||units on a scale||Standard Error|Least Squares Mean
745544|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Working Memory Section|The BRIEF-A Working Memory assesses an individuals' memory function in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Observations are rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 8 to 24.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||units on a scale||Standard Error|Least Squares Mean
745597|NCT00517075|Secondary|Global Clinical Improvement||At baseline, every 2 weeks during rTMS sessions, and at monthly follow-up visits.|P.I. has left the institution and NYSPI has no access to the data. Results will not be analyzed or presented.|||||
745598|NCT00517075|Primary|Clinical Improvement of Negative Symptoms (Positive and Negative Syndrome Scale [PANSS] Negative Symptoms Subscale) Relative to Pre-treatment Baseline.||At baseline, every 2 weeks during rTMS sessions, and at monthly follow-up visits.|P.I. has left the institution and NYSPI has no access to the data. Results will not be analyzed or presented.|||||
745545|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Task Monitor Section|The BRIEF-A Task Monitor assesses an individuals's ability to monitor a task in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Observations are rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 6 to 18.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||units on a scale||Standard Error|Least Squares Mean
745546|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Self Monitor Section|The BRIEF-A Self Monitor assesses an individuals' capacity to self monitor in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Observations are rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 6 to 18.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||units on a scale||Standard Error|Least Squares Mean
745547|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - SHIFT Section|The BRIEF-A Shift assess an individuals' shifting between different behaviors in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Observations are rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 6 to 18.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||units on a scale||Standard Error|Least Squares Mean
745548|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Plan/Organize Section|The BRIEF-A Plan/Organize asseses an individuals' capabilities to plan and organize in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Behavior is rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 10 to 30.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||units on a scale||Standard Error|Least Squares Mean
745549|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Organization of Materials Section|The BRIEF-A Organization of Materials assesses an individuals' organizing skills in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Observations are rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 8 to 24.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||units on a scale||Standard Error|Least Squares Mean
745550|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Negativity Section|The BRIEF-A Negativity asseses an indivduals' perceived negativity in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Behavior is rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 0 to 10.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||units on a scale||Standard Error|Least Squares Mean
745551|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Metacognition Section|BRIEF-A Metacognition subscale is a standardized measure assessing individual's ability to systematically solve problems via planning and organization while sustaining these task-completion efforts in active working memory. Form is designed to be completed by adults, including adults with wide variety of developmental, systemic, neurological, and psychiatric disorders. Behavior is rated on a 3-point Likert scale, with 1=behavior never observed, 2=behavior sometimes observed, and 3=behavior often observed - higher ratings indicate greater perceived impairment. Total score ranges from 40 to 120.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||units on a scale||Standard Error|Least Squares Mean
745599|NCT00517192|Secondary|Occurrence of New AIDS Progression Events or Death||through 48 weeks of treatment||||||
745600|NCT00517192|Secondary|Change From Baseline in log10 Viral Load up to Week 48||up to week 48||||||
745601|NCT00517192|Secondary|Change From Baseline in CD4+ Cell Count up to Week 48||up to week 48||||||
745602|NCT00517192|Secondary|Daily Average in Viral Load Change From Baseline up to Week 48||up to week 48||||||
745603|NCT00517192|Secondary|Daily Average in Viral Load Change From Baseline up to Week 24||up to week 24||||||
745552|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Initiate Section|The BRIEF-A Initiate rates an individual's initiative behaviors in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Behavior is rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 8 to 24.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||units on a scale||Standard Error|Least Squares Mean
745553|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Inhibit Section|The BRIEF-A Inhibit rates an individual's inhibition in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Behavior is rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 8 to 24.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||units on a scale||Standard Error|Least Squares Mean
745554|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Infrequency Section|Standardized measure assessing adult executive functioning/self-regulation in his/her everyday environment. Extent to which respondent answers additional items in an unusual and infrequent direction. Form is designed to be completed by adults 18-90 years of age, including adults with wide variety of developmental, systemic, neurological, and psychiatric disorders. Behavior is rated on 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. Total score ranges from 0 to 5.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||units on a scale||Standard Error|Least Squares Mean
745555|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Inconsistency Section|The BRIEF-A Inconsistency rates the behavioral inconsistency displayed by the patient in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Behavior is rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 0 to 20.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||units on a scale||Standard Error|Least Squares Mean
745556|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - GEC Section Score|The BRIEF-A GEC rates the global executive composite of the patient in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Behavior is rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 75 to 225.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||units on a scale||Standard Error|Least Squares Mean
745557|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Emotional Control Section Score|The BRIEF-A emotional control subscale assesses an individuals emotional control in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Behavior is rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 10 to 30.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||units on a scale||Standard Error|Least Squares Mean
745558|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Behavioral Regulation Section Score|The BRIEF-A behavioral regulation subscale measures an individuals control over behavior in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Behavior is rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 30 to 90.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||units on a scale||Standard Error|Least Squares Mean
745559|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Driving Behavior Survey-Other Report|26-item driving survey completed by someone other than the patient/driver. Examples of driving behaviors included in the survey match those listed in the Self-Report version of the scale. Items are rated on a 4-point scale (1 = not at all or rarely, 2 = sometimes, 3 = often, 4 = very often). The total score is the sum of the 26 items and ranges from 26 to 104.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||units on a scale||Standard Error|Least Squares Mean
745560|NCT00510276|Primary|Mean Change in the Conners' Adult ADHD Rating Scale-Investigator Rated: Screening Version (CAARS-Inv:SV) Total ADHD Symptom Score From Baseline to 12 Week Endpoint|CAARS-Inv:SV is a 30-item scale containing 3 subscales: the Inattention subscale, the Hyperactivity-Impulsivity subscale, and the ADHD Index. The 18-item total ADHD symptom score is the sum of the Inattention and Hyperactivity-Impulsivity subscales. Each item is scored on a 0 to 3 scale (0=not at all, never; 1=just a little, once in a while; 2=pretty much, often; 3=very much, very frequently). The scale assesses symptom severity over the past week. The total score ranges from 0 to 54.|Baseline, Week 12|Intent-to-treat population was analyzed, including all randomized patients who had both a baseline and at least 1 post baseline score.||units on a scale||Standard Error|Least Squares Mean
745561|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Driving Behavior Survey Self-Report|26 item self-rated driving survey with examples of driving behaviors, e.g.: putting on seat belt, driving within speed limits, yielding the right of way to other drivers. Items are rated on a 4-point scale (1 = not at all or rarely, 2 = sometimes, 3 = often, 4 = very often). The total score is the sum of the 26 items. A driving history is completed by self-report the first time a rater completes the Driving Behavior Survey (Self-Report). The total score ranges from 26 to 104.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward as imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||units on a scale||Standard Error|Least Squares Mean
745562|NCT00510276|Secondary|Mean Change From Baseline to 12 Week Endpoint on the Social Adaptation Self-Evaluation Scale (SASS)|Patient completed scale that consists of 21 items that examine behavior and subjective perception, including satisfaction, self-perception and motivation in participating in and maintaining relationships with family and friends, satisfaction in work, home and leisure activities, and intellectual interests. Each item is scored from 0 to 3, corresponding to minimal and maximal social adjustment, with a total score range from 0 to 60.|Baseline, 12 weeks|Analyzed was a intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||units on a scale||Standard Error|Least Squares Mean
745563|NCT00510276|Secondary|Mean Change From Baseline to 12 Week Endpoint on the Fagerstrom Test for Nicotine Dependence (FTND)|The FTND was designed to provide an ordinal measure of nicotine dependence related to cigarette smoking. It contains items that evaluate the quantity of cigarette consumption, the compulsion to use, and dependence. The FTND contains 4 yes-no and 2 multiple choice questions and can be used in a self-report format. The items on FTND are scored 0 to 3 for multiple choice items, the items are summed to yield a total score of 0-10 (0=minimum nicotine dependence; 10=maximum nicotine dependence).|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||units on a scale||Standard Error|Least Squares Mean
745564|NCT00510276|Secondary|Mean Change From Baseline to 12 Week Endpoint on the Habits Timeline Followback (TLFB) Incidence for Use of Marijuana|Variation of the Alcohol Timeline Followback (TLFB) which is a method for assessing the quantity of alcohol consumption on a daily basis. With a calendar as a guide, the interviewee provides a retrospective estimate of daily habits over a specified period of as long as the previous year. The goal is to provide a detailed record of patterns of use that can be used to guide treatment and to assess treatment outcome. Recorded is the number of joints that have been consumed.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||number of joints per day||Standard Error|Least Squares Mean
745565|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Habits Timeline Followback (TLFB) Incidence for Use of Nicotine|Variation of the Alcohol Timeline Followback (TLFB) which is a method for assessing the quantity of alcohol consumption on a daily basis. This subscale assesses the amount of nicotine consumed by an individual. With a calendar as a guide, the interviewee provides a retrospective estimate of daily habits over a specified period of as long as the previous year. The goal is to provide a detailed record of patterns of use that can be used to guide treatment and to assess treatment outcome.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||number of nicotine products per day||Standard Error|Least Squares Mean
745566|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Habits Timeline Followback (TLFB) Incidence for Use of Drugs|Variation of the Alcohol Timeline Followback (TLFB) which is a method for assessing the quantity of alcohol consumption on a daily basis. This subscale assesses the amount of recreational drugs other than marijuana an individual consumed and is expressed as the ratio of number of days on which drugs were used over the total number of days, resulting in a total score ranging from 0 to 1. With a calendar as a guide, the interviewee provides a retrospective estimate of daily habits over a specified period of as long as the previous year.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||ratio||Standard Deviation|Mean
745567|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Habits Timeline Followback (TLFB) Incidence for Use of Caffeine|Variation of the Alcohol Timeline Followback (TLFB) which is a method for assessing the quantity of alcohol consumption on a daily basis. This subscale assesses the amount of caffeine consumed by an individual. With a calendar as a guide, the interviewee provides a retrospective estimate of daily habits over a specified period of as long as the previous year. The goal is to provide a detailed record of patterns of use that can be used to guide treatment and to assess treatment outcome.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||number of caffeinated drinks per day||Standard Error|Least Squares Mean
745604|NCT00517192|Secondary|Daily Average in Viral Load Change From Baseline up to Week 8||up to week 8||||||
745605|NCT00517192|Secondary|Daily Average in CD4+ Cell Count Change From Baseline up to Week 48||up to week 48||||||
745606|NCT00517192|Secondary|Daily Average in CD4+ Cell Count Change From Baseline up to Week 24||up to week 24||||||
745607|NCT00517192|Secondary|Daily Average in CD4+ Cell Count Change From Baseline at up to Week 8||up to week 8||||||
745568|NCT00510276|Secondary|Mean Change From Baseline to 12 Week Endpoint on the Habits Timeline Followback (TLFB) Incidence for Use of Alcohol|Variation of the Alcohol Timeline Followback (TLFB) which is a method for assessing the quantity of alcohol consumption on a daily basis. With a calendar as a guide, the interviewee provides a retrospective estimate of daily habits over a specified period of as long as the previous year. The goal is to provide a detailed record of patterns of use that can be used to guide treatment and to assess treatment outcome. Recorded is the number of standard drinks that have been consumed.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||number of alcoholic drinks per day||Standard Error|Least Squares Mean
745569|NCT00510276|Secondary|Correlation of Mean Changes From Baseline to 12 Week on the Adult ADHD Quality of Life-29 Total Score and of Conners' Adult Attention-Deficit/Hyperactivity Disorder Rating Scale-Investigator Rated:Screening Version Total Score|"AAQOL-29: Patient-reported outcome measure examining disease-specific functional impariments and quality of life for adults with ADHD. The domains included in the AAQOL are life productivity, psychological health, quality of relationships, and life outlook. Consistent with the majority of existing quality of life measures, higher scores on the AAQOL-29 indicate better functioning.
CAARS-Inv:SV: Inattention subscale, Impulsivity subscale, and ADHD Index. Each item is scored on a 0 to 3 scale, assessing symptom severity over the past week. The total score is the sum of all subscale scores."|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||correlation coefficient|||Number
745570|NCT00510276|Secondary|Mean Change From Baseline to 12 Week Endpoint on the Beck Anxiety Inventory (BAI)|21-item self-reported screening tool for measuring anxiety severity. Each item is rated on a 4-point Likert scale ranging from 0 (not at all) to 3 (severely; I could barely stand it). Each item is descriptive of subjective, somatic, or panic-related symptoms of anxiety. Patients record how much they have been bothered by each symptom during the past week, including the day the questionnaire is administered. The total score ranges from 0 to 63.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward as imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||units on a scale||Standard Error|Least Squares Mean
745571|NCT00510276|Secondary|Mean Change From Baseline to 12 Week Endpoint on the Montgomery Asberg Depression Rating Scale (MADRS)|Rating scale for severity of depressive mood symptoms, administered by the investigator. The scale consists of 10 items, each rated on a scale from 0 to 6. The MADRS total score is the sum of the 10 items and the score ranges from 0 to 60. Higher scores denote more severe depressive symptoms.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||units on a scale||Standard Error|Least Squares Mean
745572|NCT00510276|Secondary|Endpoint Scores in Patient Global Impression - Improvement (PGI-I)|7-point scale modeled after the CGI on which patients rate any change in their overall status that they had experienced since beginning the study drug. The score on this scale ranges from 1 (very much improved) to 7 (very much worse).|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||units on a scale||Standard Error|Least Squares Mean
745573|NCT00510276|Secondary|Mean Change From Baseline to 12 Week Endpoint in CAARS Self Report (CAARS-S:SV) Total Score|30-item patient-reported scale with 3 subscales: Inattention subscale, Hyperactivity-Impulsivity subscale, and ADHD Index. 18-item total ADHD symptom score is the sum of the Inattention and Hyperactivity-Impulsivity subscales. Each individual item is scored on a 0 to 3 scale (0 = not at all, never; 1 = just a little, once in a while; 2 = Pretty much, often; 3 = very much, very frequently). The rating scale assesses symptom severity over the past week. The total score ranges from 0 to 54.|Baseline, 12 weeks|An intent-to-treat population was analyzed using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||units on a scale||Standard Error|Least Squares Mean
745574|NCT00510276|Secondary|Mean Change From Baseline to 12 Week Endpoint in Clinical Global Impression-ADHD- Severity (CGI-ADHD-S)|Single-item clinician rating of the clinician’s assessment of the patient’s severity of the ADHD symptoms in relation to the clinician’s total experience with ADHD patients. Severity is rated on a 7-point scale (1 = normal, not at all ill; 7 = among the most extremely ill patients). The total score ranges from 1 to 7.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||units on a scale||Standard Error|Least Squares Mean
745575|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Life Outlook Subscale|"Patient-reported outcome measure used to examine the disease specific functional impairments and quality of life for adults with ADHD. This subscale asseses life outlook. Individual items are scored on a five-point Likert-like scale from not at all/never=1 to extremely/very often=5. The range of scores for this subscale is 0 to 100. Consistent with the majority of existing quality of life measures, higher scores on the AAQOL-29 indicate better functioning."|Baseline, 12 weeks|An intent-to-treat population was analyzed. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||units on a scale||Standard Error|Least Squares Mean
745576|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Psychological Health Subscale|"Patient-reported outcome measure used to examine the disease specific functional impairments and quality of life for adults with ADHD. This subscale asseses the psychological health. Individual items are scored on a five-point Likert-like scale from not at all/never=1 to extremely/very often=5. The range of scores for this subscale is 0 to 100. Consistent with the majority of existing quality of life measures, higher scores on the AAQOL-29 indicate better functioning."|Baseline, 12 weeks|An intent-to-treat population was analyzed. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||units on a scale||Standard Error|Least Squares Mean
745608|NCT00517192|Secondary|Response up to 48 Weeks Using at Least a 1 log10 Reduction in Viral Load From Baseline Using Intent-to-treat||up to 48 weeks||||||
745577|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Life Productivity Subscale|"Patient-reported outcome measure used to examine the disease specific functional impairments and quality of life for adults with ADHD. This subscale assesses life productivity. Individual items are scored on a five-point Likert-like scale from not at all/never=1 to extremely/very often=5. The range of scores for this subscale is 0 to 100. Consistent with the majority of existing quality of life measures, higher scores on the AAQOL-29 indicate better functioning."|Baseline, 12 weeks|An intent-to-treat population was analyzed. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||units on a scale||Standard Error|Least Squares Mean
745578|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Relationship Subscale|"Patient-reported outcome measure used to examine the disease-specific functional impariments and quality of life for adults with ADHD. This subscale asseses quality of relationships. Individual items are scored on a five-point Likert-like scale from not at all/never=1 to extremely/very often=5. The range of scores for this subscale is 0 to 100. Consistent with the majority of existing quality of life measures, higher scores on the AAQOL-29 indicate better functioning."|Baseline, 12 weeks|Intent-to-treat population was used for analysis. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||units on a scale||Standard Error|Least Squares Mean
745579|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Total Score|"Patient-reported outcome measure used to examine the disease-specific functional impariments and quality of life for adults with ADHD. The domains included in the AAQOL are life productivity, psychological health, quality of relationships, and life outlook. Individual items are scored on a five-point Likert-like scale from not at all/never=1 to extremely/very often=5. The range of scores is 0 to 100. Consistent with the majority of existing quality of life measures, higher scores on the AAQOL-29 indicate better functioning."|Baseline, 12 weeks|Analyzed was an intent-to-treat population. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||units on a scale||Standard Error|Least Squares Mean
745580|NCT00510289|Secondary|Change in Microvessel Density|Microvessel density will be measured before and after treatment, and the distribution of change across time will be summarized with descriptive statistics.|Measured before and after treatment|This outcome was not analysed due to the early closure of the study.|||||
745581|NCT00510289|Secondary|Overall Survival|Overall Survival is defined as the number of months from enrollment onto the study until death from any cause in subjects who took study drug for at least cycle 1.|1 year from the last dose of study drug|7 subjects completed cycle 1 or beyond.||months||Full Range|Mean
745582|NCT00510289|Secondary|Time to Progression|Time to progression will be defined as the number of months between on-study and the date of progression or death, whichever comes first, in subjects who took study drug for at least cycle 1.|5 years|7 patients completed cycle one and had bone marrow biopsies to confirm response.||months||Full Range|Median
745583|NCT00510289|Secondary|Number of Subjects Requiring Dose Reductions|The number of subjects who took study drug for more than 1 cycle and required a dose reduction down to the next dose level.|While on study drug, a maximum of 5 years|7 Subjects completed beyond cycle 1. 4 of those subjects had dose reductions during the time they took study drug.||participants|||Number
745584|NCT00510289|Primary|Number of Subjects Achieving Hematological Response|Hematological response is defined as the number of subjects who achieve either a complete response (CR), Partial response (PR) or Hematologic improvement.(HI). HI is defined as peripheral blood counts with hemoglobin ≥11 g/dL, absolute neutrophil count ≥1x10(9)/L and platelet count ≥100x10(9)/L, and normal bone marrow morphology with no evidence of dysplasia or blasts. CR is defined as the disappearance of all signs and symptoms related to disease, along with HI. PR is defined as fulfilling the criteria for CR in the peripheral blood but blasts decreasing by 50% or more in the bone marrow or to a less advanced WHO classification pretreatment.|During treatment - up to a maximum of 5 years|There were 16 subjects enrolled in the trial. 9 subjects refused further bone marrow biopsy to assess response to therapy. Therefore, there were 7 evaluable subjects. One subject experienced PR||participants|||Number
745585|NCT00516906|Secondary|Rating of Skin Condition|Ratings of skin condition for erythema on a 0 to 3 scale (0 = None, 1=Mild, 2=Moderate, 3=Severe)|Daily up to 7 Days (average 3-7 days of wear)|||Units on a scale||Standard Deviation|Mean
745586|NCT00516906|Secondary|Clinician Overall Satisfaction With Dressing|Clinician Overall Satisfaction with Dressing Five point scale: 1= Very Good, 5= Very poor|Daily up to 7 Days (average 3-7 days of wear)|||Units on a scale||Standard Deviation|Mean
745587|NCT00516906|Primary|Clinician Overall Satisfaction With Catheter Securement|Clinician Overall Satisfaction with Catheter Securement Five Point Scale: 1 = Very Good, 5= Very Poor|Daily up to 7 Days (average 3-7 days of wear)|||Units on a scale||Standard Deviation|Mean
745588|NCT00516919|Primary|Participant BMI|Body Mass Index (BMI)|4 months and 6 month follow-up|Data for all randomized participants were included. In the event of dropout or missing data, baseline values were used.||kg/m^2||Standard Deviation|Mean
745589|NCT00517010|Secondary|1. Change in BCVA From Baseline|change in number of letter read correctly in study eye compared to the number of letters read correctly at baseline, i.e. BCVA (number of letters read correctly) at 24 months minus BCVA (number of letters read correctly) at baseline|24 months|||change in number of letters||Standard Deviation|Mean
745590|NCT00517010|Primary|Incidence and Severity of Ocular Adverse Events|Any ocular adverse event identified by eye examination during the study follow-up will be recorded and determined for possible or probable relation to study treatment.|24 months|||number of adverse events|||Number
745591|NCT00517075|Secondary|Cortical Excitability||At baseline, every 2 weeks during rTMS sessions, and at monthly follow-up visits.|P.I. has left the institution and NYSPI has no access to the data. Results will not be analyzed or presented.|||||
745592|NCT00517075|Secondary|Cognitive Function||At baseline, the first and last rTMS sessions of each study phase (random and open), and at monthly follow-up visits.|P.I. has left the institution and NYSPI has no access to the data. Results will not be analyzed or presented.|||||
745593|NCT00517075|Secondary|Smoking Behaviors||At baseline, every 2 weeks during rTMS sessions, and at monthly follow-up visits.|P.I. has left the institution and NYSPI has no access to the data. Results will not be analyzed or presented.|||||
745618|NCT00517192|Secondary|Intent-To-Treat Analysis of Virologic Response at Week 48, Using VL < 50 Copies/mL as the Response Criterion Where Patients Are Followed Until Week 48 for VL Regardless of Whether or Not They Remain on Study Drug.||48 weeks of treatment||||||
745619|NCT00517192|Secondary|Treatment Response at Week 48, Using VL < 50 Copies/mL as the Response Criterion and the FDA Definition for Handling Drug Discontinuations ((NCF) Non-Completers=Failure).||48 weeks of treatment||||||
745620|NCT00517192|Primary|Time to Virologic Failure Through 48 Weeks of Treatment, Using Viral Load (VL) < 50 Copies/Millilitre (mL) as the Response Criterion.||48 weeks of treatment||||||
745621|NCT00518284|Secondary|Diameter Stenosis|Diameter stenosis is calculated as [1 - (minimum lumen diameter (MLD) / reference vessel diameter)] * 100, where the reference vessel diameter is the vessel diameter measured in a healthy segment of the target vessel proximal as close as possible to the lesion.|9 months|Because the study was cancelled after only 6 patients were enrolled, this analysis was not performed.||percent diameter stenosis||Standard Deviation|Mean
745622|NCT00518284|Secondary|Percentage of Participants With Binary Restenosis|Binary restenosis was defined by a >50% diameter stenosis at follow-up study, assessed by angiography.|9 months|Because the study was cancelled after only 6 patients were enrolled, this analysis was not performed.||percentage of participants|||Number
745623|NCT00518284|Secondary|Late Loss|Late loss is defined as minimum lumen diameter (MLD) immediately post-procedure minus MLD at the time of follow-up, in mm.|Day 1 (following revascularization) and 9 months|Because the study was cancelled after only 6 patients were enrolled, this analysis was not performed.||mm||Standard Deviation|Mean
745624|NCT00518284|Secondary|Minimum Lumen Diameter|Minimum lumen diameter (MLD) is defined as the smallest diameter in millimeters (mm) in the arterial segment of interest measured angiographically.|9 months|Because the study was cancelled after only 6 patients were enrolled, this analysis was not performed.||mm||Standard Deviation|Mean
745625|NCT00518284|Secondary|Number of Participants With a Stroke|The number of patients experiencing a stroke during the study. Stroke was defined as any sudden development of neurological deficits lasting more than 24 hours, and if a brain imaging study is performed it shows an infarction or hemorrhage. A transient ischemic attack is a neurological deficit lasting less than 24 hours and, if an imaging study is performed, shows no evidence of infarction or hemorrhage.|Up to 11 months|Treated population.||participants|||Number
745626|NCT00518284|Secondary|Number of Participants With Myocardial Infarction (MI)|The number of patients experiencing Myocardial Infarction (MI) during the study. Myocardial Infarction was defined as new pathologic Q waves of at least 0.04 seconds, or an increase in serum creatine kinase to more than twice the normal code together with a pathologic increase in myocardial isoenzymes.|Up to 11 months|Treated population.||participants|||Number
745627|NCT00518284|Secondary|Number of Deaths|Number of patients who died due to any cause.|Up to 11 months|Treated population.||participants|||Number
745628|NCT00518284|Secondary|Target Lesion Revascularization (TLR) at 9 Months|Target lesion revascularization (TLR) was defined as repeat percutaneous intervention or bypass surgery of the previously treated target lesion (or blockage). The percentage of participants requiring revascularization of the target lesion was determined by stenosis of > 50% confirmed by angiography.|9 months|Because the study was cancelled after only 6 patients were enrolled, this analysis was not performed.||percentage of participants|||Number
745629|NCT00518284|Secondary|Decrease in Ankle Brachial Index (ABI) > 0.15|"The percentage of participants with a decrease in the Ankle Brachial Index (ABI) > 0.15.
Ankle Brachial Index = Systolic Ankle Pressure / Systolic Brachial Pressure."|Baseline and Month 9|Because the study was cancelled after only 6 patients were enrolled, this analysis was not performed.||percentage of participants|||Number
745630|NCT00518284|Secondary|Change From Baseline in Walking Impairment Questionnaire (WIQ) Score|The Walking Impairment Questionnaire (WIQ) is utilized to characterize a patient’s walking ability. Scores range from 0 (no difficulty) to 100 (much difficulty).|Baseline and Month 9|Because the study was cancelled after only 6 patients were enrolled, this analysis was not performed.||scores on a scale||Standard Deviation|Mean
745631|NCT00518284|Secondary|Systolic Velocity Ratio (SVR) > 2.0|The percentage of participants with a systolic velocity ratio > 2.0 assessed using lower extremity arterial duplex ultrasound.|9 months|Because the study was cancelled after only 6 patients were enrolled, this analysis was not performed.||percentage of participants|||Number
745632|NCT00518284|Primary|Target Vessel Revascularization at 9 Months|Target vessel revascularization (TVR) was defined as percutaneous revascularization or bypass of the target lesion or any segment of the artery containing the target lesion. The percentage of participants requiring revascularization of the target vessel was determined by stenosis of > 50% confirmed by angiography.|9 months|Because the study was cancelled after only 6 patients were enrolled, this analysis was not performed.||percentage of participants|||Number
745633|NCT00518323|Secondary|Change From Baseline to End Point in Sleep VAS for Daytime Drowsiness|The sleep VAS for daytime drowsiness is a scale for measuring the drowsiness experienced by a patient. Scores range from 0 to 100, where 100=best and 0=worst.|6 weeks|The number of participants in the intent-to-treat (ITT) analysis set was used. This set includes patients who received study drug and have at least 1 efficacy measurement. The Last Observation Carried Forward method was used for imputation; ie, the last measure for subjects who ended study early was carried forward as if they completed the study.||units on a scale||Standard Deviation|Mean
745634|NCT00518323|Secondary|Change From Baseline to End Point in Sleep Visual Analog Scale (VAS) for Quality of Sleep.|The sleep VAS for sleep quality is a scale for measuring the quality of sleep experienced by a patient. Scores range from 0 to 100, where 100=best and 0=worst.|6 weeks|The number of participants in the intent-to-treat (ITT) analysis set was used. This set includes patients who received study drug and have at least 1 efficacy measurement. The Last Observation Carried Forward method was used for imputation; ie, the last measure for subjects who ended study early was carried forward as if they completed the study.||units on a scale||Standard Deviation|Mean
745635|NCT00518323|Secondary|Change From Baseline to End Point in Children's Global Assessment (CGAS) Score|The CGAS score assesses psychological, social, and school functioning for children 6 to 17 years of age. Scores range from 1 to 100, where 100=best and 1=worst.|6 weeks|The number of participants in the intent-to-treat (ITT) analysis set was used. This set includes patients who received study drug and have at least 1 efficacy measurement. The Last Observation Carried Forward method was used for imputation; ie, the last measure for subjects who ended study early was carried forward as if they completed the study.||units on a scale||Standard Deviation|Mean
745636|NCT00518323|Secondary|Change From Baseline to End Point in Clinical Global Impression-Severity (CGI-S) Scale|The CGI-S rating scale was used to assess the severity of a subject’s overall clinical condition. Scores range from 1 to 7, where 1=best and 7=worst.|6 weeks|The number of participants in the intent-to-treat (ITT) analysis set was used. This set includes patients who received study drug and have at least 1 efficacy measurement. The Last Observation Carried Forward method was used for imputation; ie, the last measure for subjects who ended study early was carried forward as if they completed the study.||units on a scale||Full Range|Median
745637|NCT00518323|Primary|Change in the PANSS Total Score From Baseline to the Last Postrandomization Assessment in the Double-blind Period of the Study.|The Positive and Negative Syndrome Scale (PANSS) measures the severity of psychotic symptoms of schizophrenia. Scores range from 30 to 210, where 30=best and 210=worst. The change in PANSS total score for all eligible subjects was measured from the beginning of the study to the end.|6 weeks|The number of participants in the intent-to-treat (ITT) analysis set was used. This set includes patients who received study drug and have at least 1 efficacy measurement. The Last Observation Carried Forward method was used for imputation; ie, the last measure for subjects who ended study early was carried forward as if they completed the study.||units on a scale||Standard Deviation|Mean
745638|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection|"Abnormal cytology included ASC-US, LSIL, HSIL, AGC and ASC-H.
Oncogenic HPV types assessed included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 7|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)||Subjects|||Number
745639|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Oncogenic HPV Types Cervical Infection|"Abnormal cytology included ASC-US, LSIL, HSIL, AGC, and ASC-H.
Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 7|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)||Subjects|||Number
745640|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With an HPV 16 and/or HPV-18 Cervical Infection|"Abnormal cytology included ASC-US, LSIL, HSIL, AGC and ASC-H.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 7|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)||Subjects|||Number
745641|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection|"Abnormal cytology included ASC-US, LSIL, HSIL, AGC and ASC-H.
Oncogenic HPV types assessed included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 7|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)||Subjects|||Number
745642|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Oncogenic HPV Types Cervical Infection|"Abnormal cytology included ASC-US, LSIL, HSIL, AGC, and ASC-H.
Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 7|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)||Subjects|||Number
745643|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With an HPV 16 and/or HPV-18 Cervical Infection|"Abnormal cytology included atypical squamus cells of undetermined significance (ASC-US), low-grade squamous intraepithelial lesion (LSIL), high-grade squamous intraepithelial lesion (HSIL), atypical glandular cells (AGC), atypical squamus cells and cannot exclude HSIL (ASC-H).
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 7|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)||Subjects|||Number
745644|NCT00518336|Secondary|Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN2+ was defined as CIN grades 2 and 3, AIS and invasive cervical cancer.
Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 7|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)||Subjects|||Number
745663|NCT00518336|Secondary|Number of Subjects With New Onset Chronic Diseases (NOCD) up to Year 9|NOCDs include for example asthma, type I diabetes, allergies, ...|Up to year 9|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo).||Subjects|||Number
745645|NCT00518336|Secondary|Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN2+ was defined as CIN grades 2 and 3, AIS and invasive cervical cancer.
Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 7|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)||Subjects|||Number
745646|NCT00518336|Secondary|Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN2+ was defined as CIN grades 2 and 3, AIS and invasive cervical cancer.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 7|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)||Subjects|||Number
745647|NCT00518336|Secondary|Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN1+ was defined as CIN grades 1,2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.
Oncogenic HPV types assessed included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 7|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)||Subjects|||Number
745648|NCT00518336|Secondary|Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN1+ was defined as CIN grades 1,2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.
Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 7|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)||Subjects|||Number
745649|NCT00518336|Secondary|Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN1+ was defined as CIN grades 1,2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 7|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)||Subjects|||Number
745650|NCT00518336|Secondary|Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types|"Individual oncogenic non-vaccine HPV types include HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Persistent cervical HPV infection (12-month definition) was defined as detection of the same HPV type in cervical specimens at all consecutive evaluations over a minimum of 10 months.
Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 7|The According-To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.||Subjects|||Number
745651|NCT00518336|Secondary|Number of Subjects With Persistent Infection (12-month Definition) With Any Oncogenic HPV Type|"Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Persistent cervical HPV infection (12-month definition) was defined as detection of the same HPV type in cervical specimens at all consecutive evaluations over a minimum of 10 months.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 7|The According-To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.||Subjects|||Number
745652|NCT00518336|Secondary|Number of Subjects With Persistent Infection (12-month Definition) With HPV-16 and/or HPV-18|"Persistent cervical HPV infection (12-month definition) was defined as detection of the same HPV type in cervical specimens at all consecutive evaluations over a minimum of 10 months.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 7|The According-To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.||Subjects|||Number
745664|NCT00518336|Secondary|Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset|Data are expressed as Geometric Mean Titers (GMTs). The titer is the serum dilution giving a 50 percent reduction of the signal compared to a control without serum|At Month 77 until year 9 (Month 113)|The analyses were performed on the ATP cohort for immunogenicity, which included evaluable subjects for whom immunogenicity data were available.||Titer||95% Confidence Interval|Geometric Mean
745653|NCT00518336|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types|"Oncogenic HPV types included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Persistent cervical HPV infection (6-month definition) was defined as detection of the same HPV type in cervical specimens at 2 consecutive evaluations over a minimum of 5 months.
Subjects with an event did not report the same event during the earlier studies. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 7|The According-To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.||Subjects|||Number
745654|NCT00518336|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With Any Oncogenic HPV Type|"Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Persistent cervical HPV infection (6-month definition) was defined as detection of the same HPV type in cervical specimens at 2 consecutive evaluations over a minimum of 5 months.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 7|The According-To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.||Subjects|||Number
745655|NCT00518336|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 and/or HPV-18|"Persistent cervical HPV infection (6-month definition) was defined as detection of the same HPV type in cervical specimens at 2 consecutive evaluations over a minimum of 5 months.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study"|Up to year 7|The According -To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.||Subjects|||Number
745656|NCT00518336|Secondary|Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type.|"Oncogenic types included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 7|The According -To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.||Subjects|||Number
745657|NCT00518336|Secondary|Number of Subjects Presenting Cervical Infections With Any Oncogenic HPV Type.|"Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 7|The According -To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.||Subjects|||Number
745658|NCT00518336|Primary|Number of Subjects Presenting Cervical Infections With Human Papillomavirus (HPV) -16 and /or HPV-18|Cervical HPV infection was defined as the first detection of an HPV type in a subject previously negative for that HPV type.|Up to year 7|The According -To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.||Subjects|||Number
745659|NCT00518336|Primary|Number of Subjects Presenting Cervical Infections With Human Papillomavirus (HPV) -16 and/or HPV-18|Cervical HPV infection was defined as the first detection of an HPV type in a subject previously negative for that HPV type|Up to year 9|The According-To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.||Subjects|||Number
745660|NCT00518336|Secondary|Number of Subjects With Serious Adverse Events (SAEs) up to Year 9.|SAEs assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject|up to year 9|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)||Subjects|||Number
745661|NCT00518336|Secondary|Number of Subjects With Medically Signifant Conditions up to Year 9|Medically significant conditions include adverse events (AEs) prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|Up to year 9|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)||Subjects|||Number
745662|NCT00518336|Secondary|Number of Subjects With New Onset Autoimmune Disease (NOAD) up to Year 9.||Up to year 9|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)||Subjects|||Number
755605|NCT00597558|Secondary|Serum CAP-FEIA to Egg|Measure of serum CAP-FEIA to egg from subjects on egg OIT after completion of treatment compared to baseline|24-60 months|||ku/L||Full Range|Mean
745665|NCT00518336|Secondary|Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort|"Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked immunosorbent assay (ELISA) Units per milliliter (EL.U/mL).
The cut-off-vales assessed were >= 8 or 7 EL. U/mL for anti-HPV-16 and 18, respectively."|At Month 77 until year 9 (Month 113)|The analyses were performed on the ATP cohort for immunogenicity, which included evaluable subjects for whom immunogenicity data were available.||EL. U/mL||95% Confidence Interval|Geometric Mean
745666|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection|"Abnormal cytology included ASC-US, LSIL, HSIL, AGC and ASC-H.
Oncogenic HPV types assessed included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 9|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)||Subjects|||Number
745667|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Oncogenic HPV Types Cervical Infection|"Abnormal cytology included ASC-US, LSIL, HSIL, AGC, and ASC-H.
Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 9|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)||Subjects|||Number
745668|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With an HPV 16 and/or HPV-18 Cervical Infection|"Abnormal cytology included ASC-US, LSIL, HSIL, AGC and ASC-H.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 9|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)||Subjects|||Number
745669|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection|"Abnormal cytology included ASC-US, LSIL, HSIL, AGC and ASC-H.
Oncogenic HPV types assessed included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study"|Up to year 9|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)||Subjects|||Number
745670|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With Oncogenic HPV Types Cervical Infection|"Abnormal cytology included ASC-US, LSIL, HSIL, AGC, and ASC-H.
Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 9|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)||Subjects|||Number
745671|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With an HPV 16 and/or HPV-18 Cervical Infection|"Abnormal cytology included atypical squamus cells of undetermined significance (ASC-US), low-grade squamous intraepithelial lesion (LSIL), high-grade squamous intraepithelial lesion (HSIL), atypical glandular cells (AGC), atypical squamus cells and cannot exclude HSIL (ASC-H).
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study"|Up to year 9|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)||Subjects|||Number
745672|NCT00518336|Secondary|Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN2+ was defined as CIN grades 2 and 3, AIS and invasive cervical cancer.
Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 9|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)||Subjects|||Number
745673|NCT00518336|Secondary|Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN2+ was defined as CIN grades 2 and 3, AIS and invasive cervical cancer.
Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 9|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)||Subjects|||Number
745692|NCT00518336|Secondary|Number of Subjects With NOCD up to Year 8|"NOCDs included for example asthma, type I diabetes, allergies, ...
NOCDs which were not unblinded at the subject level at the time of the analysis are not presented and will be disclosed as soon as they become available."|Up to year 8|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)||subjects|||Number
745674|NCT00518336|Secondary|Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN2+ was defined as CIN grades 2 and 3, AIS and invasive cervical cancer.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 9|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)||Subjects|||Number
745675|NCT00518336|Secondary|Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN1+ was defined as CIN grades 1,2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.
Oncogenic HPV types assessed included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 9|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)||Subjects|||Number
745676|NCT00518336|Secondary|Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN1+ was defined as CIN grades 1,2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.
Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 9|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)||Subjects|||Number
745677|NCT00518336|Secondary|Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen|"Cervical Intraepithelial Neoplasia (CIN1)+ was defined as CIN grades 1,2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 9|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)||Subjects|||Number
745678|NCT00518336|Secondary|Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types|"Individual oncogenic non-vaccine HPV types include HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Persistent cervical HPV infection (12-month definition) was defined as detection of the same HPV type in cervical specimens at all consecutive evaluations over a minimum of 10 months.
Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study"|Up to year 9|The According-To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.||Subjects|||Number
745679|NCT00518336|Secondary|Number of Subjects With Persistent Infection (12-month Definition) With Any Oncogenic HPV Types|"Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Persistent cervical HPV infection (12-month definition) was defined as detection of the same HPV type in cervical specimens at all consecutive evaluations over a minimum of 10 months.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 9|The According-To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.||Subjects|||Number
745680|NCT00518336|Secondary|Number of Subjects With Persistent Infection (12-month Definition) With HPV-16 and/or HPV-18|"Persistent cervical HPV infection (12-month definition) was defined as detection of the same HPV type in cervical specimens at all consecutive evaluations over a minimum of 10 months.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study"|Up to year 9|The According-To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.||Subjects|||Number
745681|NCT00518336|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types|"Oncogenic HPV types included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Persistent cervical HPV infection (6-month definition) was defined as detection of the same HPV type in cervical specimens at 2 consecutive evaluations over a minimum of 5 months.
Subjects with an event did not report the same event during the earlier studies. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 9|The According-To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.||Subjects|||Number
745693|NCT00518336|Secondary|Number of Subjects With New Onset Chronic Diseases (NOCD) up to Year 7|NOCDs include for example asthma, type I diabetes, allergies, ...|Up to year 7|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)||subjects|||Number
745682|NCT00518336|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With Any Oncogenic HPV Type|"Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Persistent cervical HPV infection (6-month definition) was defined as detection of the same HPV type in cervical specimens at 2 consecutive evaluations over a minimum of 5 months.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 9|The According-To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.||Subjects|||Number
745683|NCT00518336|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 and/or HPV-18|"Persistent cervical HPV infection (6-month definition) was defined as detection of the same HPV type in cervical specimens at 2 consecutive evaluations over a minimum of 5 months.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study"|Up to year 9|The According -To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study, who complied with the protocol and for whom efficacy data were available.||Subjects|||Number
745684|NCT00518336|Secondary|Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type|"Oncogenic types included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 9|The According -To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.||Subjects|||Number
745685|NCT00518336|Secondary|Number of Subjects Presenting Cervical Infections With Any Oncogenic HPV Type.|"Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 9|The According -To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.||Subjects|||Number
745686|NCT00518336|Secondary|Number of Subjects With SAEs up to Year 8|SAEs assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject|up to year 8|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)||subjects|||Number
745687|NCT00518336|Secondary|Number of Subjects With Serious Adverse Events (SAEs) up to Year 7|SAEs assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject|Up to year 7|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)||subjects|||Number
745688|NCT00518336|Secondary|Number of Subjects With Medically Significant Conditions up to Year 8|"Medically significant conditions include adverse events (AEs) prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
Medically significant conditions which were not unblinded at the time of the analysis are not presented yet."|up to year 8|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)||subjects|||Number
745689|NCT00518336|Secondary|Number of Subjects With Medically Significant Conditions up to Year 7|"Medically significant conditions include adverse events (AEs) prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
Medically significant conditions which were not unblinded at the time of the analysis are not presented yet."|Up to year 7|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)||subjects|||Number
745690|NCT00518336|Secondary|Number of Subjects With NOAD up to Year 8|The values of NOADs are not yet corresponding to the values in each group. The cases are still blinded. They will be disclosed as soon as the results will be available.|Up to year 8|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)||subjects|||Number
745691|NCT00518336|Secondary|Number of Subjects With New Onset Autoimmune Disease (NOAD) up to Year 7||Up to year 7|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)||subjects|||Number
746101|NCT00513526|Secondary|HPV Antibody Titers to Type 11 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status||weeks 0, 28, and 76|Intent to treat population, includes all participants who received at least one dose of vaccine||Milli-Merck units/mL||95% Confidence Interval|Geometric Mean
745694|NCT00518336|Secondary|Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset|Data are expressed as Geometric Mean Titers (GMTs). The titer is the serum dilution giving a 50 percent reduction of the signal compared to a control without serum|At Months 77-101|The analyses were performed on a subset of the ATP cohort for immunogenicity, which included evaluable subjects for whom immunogenicity data were available.||titer||95% Confidence Interval|Geometric Mean
745695|NCT00518336|Secondary|Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort|Titers are given as Geometric Mean Titers (GMTs) expressed as ELISA Units per milliliter (EL.U/mL).|At Months 77-101|The analyses were performed on the ATP cohort for immunogenicity, which included evaluable subjects for whom immunogenicity data were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
745696|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection|"Abnormal cytology included ASC-US, LSIL, HSIL, AGC and ASC-H.
Oncogenic HPV types assessed included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 8|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)||subjects|||Number
745697|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Oncogenic HPV Types Cervical Infection|"Abnormal cytology included ASC-US, LSIL, HSIL, AGC, and ASC-H.
Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 8|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)||subjects|||Number
745698|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With an HPV 16 and/or HPV-18 Cervical Infection|"Abnormal cytology included ASC-US, LSIL, HSIL, AGC and ASC-H.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 8|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)||subjects|||Number
745699|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection|"Abnormal cytology included ASC-US, LSIL, HSIL, AGC and ASC-H.
Oncogenic HPV types assessed included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 8|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)||subjects|||Number
745700|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Oncogenic HPV Types Cervical Infection|"Abnormal cytology included ASC-US, LSIL, HSIL, AGC, and ASC-H.
Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 8|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)||subjects|||Number
745701|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With an HPV 16 and/or HPV-18 Cervical Infection|"Abnormal cytology included atypical squamus cells of undetermined significance (ASC-US), low-grade squamous intraepithelial lesion (LSIL), high-grade squamous intraepithelial lesion (HSIL), atypical glandular cells (AGC), atypical squamus cells and cannot exclude HSIL (ASC-H).
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 8|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)||subjects|||Number
745702|NCT00518336|Secondary|Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN2+ was defined as CIN grades 2 and 3, AIS and invasive cervical cancer.
Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Subjects with an event did not report the same event in the earlier studies. and were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 8|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)||subjects|||Number
745703|NCT00518336|Secondary|Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN2+ was defined as CIN grades 2 and 3, AIS and invasive cervical cancer.
Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 8|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)||subjects|||Number
745704|NCT00518336|Secondary|Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN2+ was defined as CIN grades 2 and 3, AIS and invasive cervical cancer.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 8|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)||subjects|||Number
745705|NCT00518336|Secondary|Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN1+ was defined as CIN grades 1,2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.
Oncogenic HPV types assessed included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 8|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)||subjects|||Number
745706|NCT00518336|Secondary|Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN1+ was defined as CIN grades 1,2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.
Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 8|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)||subjects|||Number
745707|NCT00518336|Secondary|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN1+ was defined as CIN (Cervical Intraepithelial Neoplasia) grades 1,2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 8|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)||subjects|||Number
745708|NCT00518336|Secondary|Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types|"Individual oncogenic non-vaccine HPV types include HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Persistent cervical HPV infection (12-month definition) was defined as detection of the same HPV type in cervical specimens at all consecutive evaluations over a minimum of 10 months.
Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 8|The ATP cohort for analysis of efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. who met all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.||subjects|||Number
745709|NCT00518336|Secondary|Number of Subjects With Persistent Infection (12-month Definition) With Any Oncogenic HPV Types|"Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Persistent cervical HPV infection (12-month definition) was defined as detection of the same HPV type in cervical specimens at all consecutive evaluations over a minimum of 10 months.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 8|The ATP cohort for analysis of efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. who met all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.||subjects|||Number
745710|NCT00518336|Secondary|Number of Subjects With Persistent Infection (12-month Definition) With HPV-16 and/or HPV-18|"Persistent cervical HPV infection (12-month definition) was defined as detection of the same HPV type in cervical specimens at all consecutive evaluations over a minimum of 10 months.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 8|The ATP cohort for analysis of efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. who met all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.||subjects|||Number
745711|NCT00518336|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types|"Oncogenic HPV types included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Persistent cervical HPV infection (6-month definition) was defined as detection of the same HPV type in cervical specimens at 2 consecutive evaluations over a minimum of 5 months.
Subjects with an event did not report the same event during the earlier studies. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 8|The ATP cohort for analysis of efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. who met all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.||Subjects|||Number
745931|NCT00519649|Secondary|Number of Participants Reporting Serious Adverse Events (SAE)|"An SAE is any untoward medical occurrence that:
results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above."|After the challenge dose of HBV vaccine.|||participants|||Number
745712|NCT00518336|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With Any Oncogenic HPV Types|"Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Persistent cervical HPV infection (6-month definition) was defined as detection of the same HPV type in cervical specimens at 2 consecutive evaluations over a minimum of 5 months.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 8|The ATP cohort for analysis of efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. who met all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.||subjects|||Number
745713|NCT00518336|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 and/or HPV-18|"Persistent cervical HPV infection (6-month definition) was defined as detection of the same HPV type in cervical specimens at 2 consecutive evaluations over a minimum of 5 months.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 8|The ATP cohort for analysis of efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. who met all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.||subjects|||Number
745714|NCT00518336|Secondary|Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type|"Oncogenic types included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 8|The ATP cohort for analysis of efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. who met all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.||subjects|||Number
745715|NCT00518336|Secondary|Number of Subjects Presenting Cervical Infections With Any Oncogenic HPV Type|"Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 8|The ATP cohort for analysis of efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. who met all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.||subjects|||Number
745716|NCT00518336|Primary|Number of Subjects Presenting Cervical Infections With Human Papillomavirus (HPV) -16 and/or HPV-18|Cervical HPV infection was defined as the first detection of an HPV type in a subject previously negative for that HPV type.|Up to year 8|According-To-Protocol (ATP) cohort for analysis of efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. who met all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.||subjects|||Number
745717|NCT00518531|Secondary|Medication Adherence Rating Scale (MARS) to Alendronate in the Second Treatment Period|The MARs questionnaire is a validated, self-reported instrument for assessing treatment adherence. Participants report how often they engage in each of 5 aspects of non-adherent behavior (forgetting to take a dose, changing the dose, stop taking them for a while, deciding to not take a dose, or taking less than instructed). Scores are summed over the 5 items, the total score ranges from 5 to 25 with higher scores indicating greater self-reported adherence. The MARS was collected at the month 6 and month 12 visits of each treatment period only for those participants receiving oral alendronate during that period.|Month 18, Month 24 (treatment period 2)|"Participants in the PRO analysis set with at least one post-baseline assessment in both periods and with observed data; n indicates the number of patients with available data at each time point."||scores on a scale||Standard Deviation|Mean
745718|NCT00518531|Secondary|Medication Adherence Rating Scale (MARS) to Alendronate in the First Treatment Period|The MARs questionnaire is a validated, self-reported instrument for assessing treatment adherence. Participants report how often they engage in each of 5 aspects of non-adherent behavior (forgetting to take a dose, changing the dose, stop taking them for a while, deciding to not take a dose, or taking less than instructed). Scores are summed over the 5 items, the total score ranges from 5 to 25 with higher scores indicating greater self-reported adherence. The MARS was collected at the month 6 and month 12 visits of each treatment period only for those participants receiving oral alendronate during that period.|Month 6, Month 12 (treatment period 1)|"Participants in the PRO analysis set with observed data; n indicates the number of patients with available data at each time point."||scores on a scale||Standard Deviation|Mean
745719|NCT00518531|Secondary|Beliefs About Medicines Questionnaire (BMQ) Preference Score|The BMQ is a 22- item self-reported questionnaire specific to osteoporosis that measures beliefs about the weekly pill or every 6 months injection. The BMQ consists of 3 subscales measuring beliefs about the necessity of the medication for controlling osteoporosis, concern with the adverse consequences of taking the medication, and preference for one medication over the other. The BMQ preference score, which measures a participant's overall evaluation of a medication, is based on the average of 7 items in the BMQ. The preference score ranges from 1 to 5, with higher scores indicating stronger preference for one medication over the other.|Baseline and Month 6, Month 12, Month 18, and Month 24|"Participants in the PRO analysis set with observed data; n indicates the number of patients with available data at each time point."||scores on a scale||Standard Deviation|Mean
745731|NCT00518531|Secondary|Compliance With Treatment in the Second Treatment Period|Participants were considered compliant to denosumab treatment if they received 2 denosumab injections (overall treatment compliance) and if they took each injection 6 months (± 4 weeks) apart (treatment compliance over time). Participants were considered compliant to alendronate treatment if they took ≥ 80% QW tablets (overall treatment compliance).|Treatment period 2 (Month 13 to Month 24)|Crossover set||Participants|||Number
745720|NCT00518531|Secondary|Beliefs About Medicines Questionnaire (BMQ) Concern Score|The BMQ is a 22- item self-reported questionnaire specific to osteoporosis that measures beliefs about the weekly pill or every 6 months injection. The BMQ consists of 3 subscales measuring beliefs about the necessity of the medication for controlling osteoporosis, concern with the adverse consequences of taking the medication, and preference for one medication over the other. Participants' concern about the adverse consequences of taking the medication for controlling osteoporosis was based on the average of 10 items from the BMQ that form the concern score. The concern score ranges from 1 to 5, with higher scores indicating stronger concerns about the adverse consequences of taking the prescribed medication for controlling osteoporosis.|Baseline and Month 6, Month 12, Month 18, and Month 24|"Participants in the PRO analysis set with observed data; n indicates the number of patients with available data at each time point."||scores on a scale||Standard Deviation|Mean
745721|NCT00518531|Secondary|Beliefs About Medicines Questionnaire (BMQ): Necessity Score|"The BMQ is a 22- item self-reported questionnaire specific to osteoporosis that measures beliefs about the weekly pill or every 6 months injection. The BMQ consists of 3 subscales measuring beliefs about the necessity of the medication for controlling osteoporosis, concern with the adverse consequences of taking the medication, and preference for one medication over the other.
Participants' beliefs about the necessity of the prescribed medication to treat osteoporosis were based on the average of 5 items from the BMQ that form the necessity score. The necessity score ranges from 1 to 5, with higher scores indicating stronger beliefs about the necessity of the prescribed medication for controlling osteoporosis."|Baseline, Month 6, Month 12, Month 18 and Month 24|"Participants in the PRO analysis set with observed data; n indicates the number of patients with available data at each time point."||scores on a scale||Standard Deviation|Mean
745722|NCT00518531|Secondary|Overall Satisfaction to Study Treatment|"Participant satisfaction with their treatment was assessed using question 7 (ie, “Please rate your satisfaction with the weekly pill on the following: frequency of administration; mode of administration [taking a pill]; convenience; overall satisfaction”) and question 8 (ie, “Please rate your satisfaction with the six month injection on the following: frequency of administration; mode of administration [receiving an injection]; convenience; overall satisfaction”) from the Preference Satisfaction Questionnaire (PSQ) at the end of each treatment period. The PSQ is a 34 item, self-report questionnaire of participants’ preference and satisfaction for each of the two study treatments. Possible answers include: Not at all Satisfied, A Little Satisfied, Moderately Satisfied, Quite Satisfied, and Very Satisfied."|End of treatment period 1 (Month 12)|The Patient Reported Outcomes (PRO) analysis set for each independent treatment period included patients in the FAS who received at least one dose of study drug and had at least one post-baseline assessment in the relevant treatment period. Analysis population includes patients with observed data for ≥1 question in the questionnaire.||Participants|||Number
745723|NCT00518531|Secondary|Time to Non-persistence to Alendronate Treatment in the Second Treatment Period|Time to non-persistence for alendronate is defined for each treatment period as the first time <2 tablets were taken in a rolling 4-week time period (e.g. study weeks 1-4, 2-5, 3-6 etc) and where the participant never reaches this threshold again during the treatment period. Tablet intake was tracked using a Medication Event Monitoring System.|Treatment period 2 (Month 13 to Month 24)|Crossover set||weeks||Standard Error|Mean
745724|NCT00518531|Secondary|Time to Non-persistence to Alendronate Treatment in the First Treatment Period|Time to non-persistence for alendronate is defined for each treatment period as the first time <2 tablets were taken in a rolling 4-week time period (e.g. study weeks 1-4, 2-5, 3-6 etc) and where the participant never reaches this threshold again during the treatment period. Tablet intake was tracked using a Medication Event Monitoring System.|Treatment period 1 (Month 1 to Month 12)|Full analysis set||weeks||Standard Error|Mean
745725|NCT00518531|Secondary|Time to Non-compliance to Alendronate Treatment in the Second Treatment Period|Time to treatment non-compliance for alendronate is based on the percent of QW tablets taken and is defined for each treatment period as the first week since Study Day 1 of the treatment period to the week where the percent of QW tablets taken falls below the threshold of ≥ 80% and where the participant can not reach this threshold again during the treatment period.|Treatment period 2 (Month 13 to Month 24)|crossover set||weeks||Standard Error|Mean
745726|NCT00518531|Secondary|Time to Non-compliance to Alendronate Treatment in the First Treatment Period|Time to treatment non-compliance for alendronate is based on the percent of QW tablets taken and is defined for each treatment period as the first week since Study Day 1 of the treatment period to the week where the percent of QW tablets taken falls below the threshold of ≥ 80% and where the participant can not reach this threshold again during the treatment period.|Treatment period 1 (Month 1 to Month 12)|Full analysis set||weeks||Standard Error|Mean
745727|NCT00518531|Secondary|Time to Non-adherence to Alendronate Treatment in the Second Treatment Period|Time to treatment non-adherence for alendronate is defined for each treatment period as the time to treatment non-compliance or time to treatment non-persistence, whichever occurs earliest, for participants with uncensored values. Participants who had both censored time to non-compliance and censored time to non-persistence values were censored in the analysis at the end of treatment period visit.|Treatment Period 2 (Month 13 to Month 24)|Crossover set||weeks||Standard Error|Mean
745728|NCT00518531|Secondary|Time to Non-adherence to Alendronate Treatment in the First Treatment Period|Time to treatment non-adherence for alendronate is defined for each treatment period as the time to treatment non-compliance or time to treatment non-persistence, whichever occurs earliest, for participants with uncensored values. Participants who had both censored time to non-compliance and censored time to non-persistence values were censored in the analysis at the end of treatment period visit.|Treatment Period 1 (Month 1 to Month 12)|Full analysis set||weeks||Standard Error|Mean
745729|NCT00518531|Secondary|Persistence With Treatment in the Second Treatment Period|Denosumab-treated participants were considered persistent to treatment if they completed the relevant treatment period and alendronate-treated participants were considered persistent to treatment if they completed the relevant treatment period and took at least 2 tablets in the last month of the treatment period.|Treatment period 2 (Month 13 to Month 24)|Crossover set||Participants|||Number
745730|NCT00518531|Secondary|Persistence With Treatment in the First Treatment Period|Denosumab-treated participants were considered persistent to treatment if they completed the relevant treatment period and alendronate-treated participants were considered persistent to treatment if they completed the relevant treatment period and took at least 2 tablets in the last month of the treatment period.|Treatment period 1 (Month 1 to Month 12)|Full analysis set||Participants|||Number
745732|NCT00518531|Secondary|Compliance With Treatment in the First Treatment Period|Participants were considered compliant to denosumab treatment if they received 2 denosumab injections (overall treatment compliance) and if they took each injection 6 months (± 4 weeks) apart (treatment compliance over time). Participants were considered compliant to alendronate treatment if they took ≥ 80% QW tablets (overall treatment compliance).|Treatment period 1 (Month 1 to Month 12)|Full analysis set||Participants|||Number
745733|NCT00518531|Secondary|Adherence With Treatment in the Second Treatment Period|A participant was considered adherent to denosumab treatment if the participant: - received 2 denosumab injections (overall treatment compliance); - took each injection 6 months (± 4 weeks) apart (treatment compliance over time); - completed the relevant treatment period (treatment persistence). A participant was considered adherent to alendronate treatment if the participant: - took ≥ 80% QW tablets (overall treatment compliance); - took at least 2 tablets in the last month and completed the relevant treatment period (treatment persistence). Participants who did not meet all criteria for their assigned treatment were deemed nonadherent to treatment.|Treatment period 2 (Months 13 to 24)|The cross-over analysis set includes all participants who crossed over to their treatment period 2 treatment.||Participants|||Number
745734|NCT00518531|Primary|Adherence With Treatment in the First Treatment Period|A participant was considered adherent to denosumab treatment if the participant: - received 2 denosumab injections (overall treatment compliance); - took each injection 6 months (± 4 weeks) apart (treatment compliance over time); - completed the relevant treatment period (treatment persistence). A participant was considered adherent to alendronate treatment if the participant: - took ≥ 80% QW tablets (overall treatment compliance); - took at least 2 tablets in the last month and completed the relevant treatment period (treatment persistence). Participants who did not meet all criteria for their assigned treatment were deemed non-adherent to treatment.|Treatment period 1 (Month 1 to Month 12)|The full analysis set (FAS) includes all participants who were randomized.||Participants|||Number
745735|NCT00518622|Primary|Antiviral Activity of MK7009|Change from Baseline in Log10 IU/mL hepatitis C virus (HCV) ribonucleic acid (RNA) on Day 8|Baseline and Day 8|Per-protocol population (defined as the study participants that completed the study as defined by the protocol). One participant was excluded from the analysis due to incorrect dosing of study medication.||Log10 IU/mL HCV RNA||Standard Deviation|Mean
745736|NCT00518622|Primary|Safety and Tolerability of MK7009|Number of participants who reported adverse experiences while on study medication as well as for 14 days after completion of study medication|14 days after completion of study therapy|All treated patients are included in the safety analysis.||Participants|||Number
745737|NCT00518687|Secondary|Number of Participants With Surgical-site Staphylococcus Aureus Infection|Diagnosis of the Staphylococcus aureus infections employed standardized definitions adapted from the CDC Guidelines for Nosocomial infections. A Staphylococcus infection surgical-site infection included any superficial incisional, deep incisional, or organ/space infection at the sternal site, the vascular harvest (donor) site, or any other site at which the surgery was performed.|Up to 90 days after surgery|The population analyzed was the full analysis set: participants who were vaccinated and subsequently underwent cardiothoracic surgery involving full median sternotomy at least 14 days and at most 60 days after vaccination||participants|||Number
745738|NCT00518687|Secondary|Number of Participants With Invasive Staphylococcus Aureus Infection|Diagnosis of the Staphylococcus aureus infections employed standardized definitions adapted from the CDC Guidelines for Nosocomial infections. An invasive Staphylococcus infection included bacteremia, deep sternal wound infection, deep-tissue organ/space infection at another surgical site, or any other deep-tissue infection.|Up to 90 days after surgery|The population analyzed was the full analysis set: participants who were vaccinated and subsequently underwent cardiothoracic surgery involving full median sternotomy at least 14 days and at most 60 days after vaccination||participants|||Number
745739|NCT00518687|Primary|Incidence Rate of Vaccine-related Serious Adverse Experiences|Vaccine-related adverse experiences were those deemed by the investigator to be possibly, probably, or definitely vaccine related. A serious adverse experience was any adverse experience occurring at any dose that 1) resulted in death, 2) was life threatening, 3) resulted in a persistent or significant disability/incapacity, 4) resulted in or prolonged an existing inpatient hospitalization, 5) was a congenital anomaly/birth defect, 6) was a cancer, 7) was an overdose, or 8) jeopardized the participant and required medical or surgical intervention.|Up to 360 days after surgery|The population analyzed included all vaccinated participants with follow-up results||Events per 100 person-years|||Number
745740|NCT00518687|Primary|Number of Participants With Staphylococcus Aureus Bacteremia and/or Deep Sternal Wound Infection|Diagnosis of the Staphylococcus aureus infections employed standardized definitions adapted from the Centers for Disease Control (CDC) Guidelines for Nosocomial infections (Garner JS, Jarvis WS, Emori TG, et al. CDC definitions for nosocomial infections. APIC Infect Control App Epidemiol 1996;A1-20). Bacteremia was defined as ≥1 positive blood culture for S. aureus regardless of the presence of clinical symptoms. A Staphylococcus aureus deep sternal wound infection included mediastinitis or a deep incisional surgical-site infection involving the sternal wound.|Up to 90 days after surgery|The population analyzed was the full analysis set: participants who were vaccinated and subsequently underwent cardiothoracic surgery involving full median sternotomy at least 14 days and at most 60 days after vaccination||participants|||Number
745741|NCT00518713|Other Pre-specified|Percent Reduction of Total (Drop and Non-Drop) Seizures.|This outcome measure evaluated the percent reduction in average weekly rate in total (drop and non-drop) seizures. Drop seizures were defined as a drop attack or spell (atonic, tonic or myoclonic) involving the entire body, trunk, or head that led to a fall, injury, slumping in chair, or head hitting surface or that could have led to a fall or injury, depending on the position of the patient at the time of the attack or spell. Non-drop seizures were other seizures not meeting the drop seizure definition.|4-week baseline period and 12-week maintenance period|||Percent reduction||Full Range|Least Squares Mean
745742|NCT00518713|Other Pre-specified|Percent Reduction in the Number of Non-drop Seizures.|This outcome measure evaluated the percent reduction (average per week) in non-drop Seizures. Non-drop seizures were other seizures not meeting the drop seizure definition. Drop seizures were defined as a drop attack or spell (atonic, tonic or myoclonic) involving the entire body, trunk, or head that led to a fall, injury, slumping in chair, or head hitting surface or that could have led to a fall or injury, depending on the position of the patient at the time of the attack or spell.|4-week baseline period and the 12-week maintenance period|||Percent reduction||Full Range|Least Squares Mean
745743|NCT00518713|Secondary|Parent/Caregiver Global Evaluations of the Patient’s Overall Change in Symptoms.|"The parent/caregiver was asked to rate the patient's overall change in symptoms and overall change in seizure activity and Quality of Life since the beginning of clobazam treatment by checking very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse."|Week 15|Those patients in the MITT population who had a baseline and Week 15 parent/caregiver global evaluations were analyzed.||participants|||Number
745744|NCT00518713|Secondary|Investigator Global Evaluations of the Patient's Overall Change in Symptoms.|"The physician was asked to rate the patient's overall change in symptoms and overall change in seizure activity and Quality of Life since the beginning of clobazam treatment by checking very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse."|Week 15|Those patients in the MITT population who completed a Physician Global Evaluation at Week 15.||participants|||Number
745745|NCT00518713|Secondary|Tolerance|Study responders who have ≥50% reduction in their drop seizure rate during the first 4 or first 8 weeks of maintenance compared to the 4 week baseline period.|4-week baseline period and first 4/first 8 weeks of the maintenance period|MITT||Participants|||Number
745746|NCT00518713|Secondary|Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (Last 4 Weeks of the 12-week Maintenance Period).|Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal.|4-week baseline period and the last 4 weeks of the 12-week maintenance period|||Percent Responders|||Number
745747|NCT00518713|Secondary|Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (Middle 4 Weeks of the 12-week Maintenance Period).|Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal.|4-week baseline period and the middle 4 weeks of the 12-week maintenance period|||Percent Responders|||Number
745748|NCT00518713|Secondary|Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (First 4 Weeks of the 12-week Maintenance Period).|Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal.|4-week baseline period and the first 4 weeks of the 12-week maintenance period|MITT||Percent of responders|||Number
745749|NCT00518713|Secondary|Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (12-week Maintenance Period).|Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal.|4-week baseline period and the 12-week maintenance period|||Percent of responders|||Number
745750|NCT00518713|Secondary|Percent Reduction in Number of Drop Seizures (Last 4 Weeks of the 12-week Maintenance Period).|Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal.|4-week baseline period and the last 4 weeks of the 12-week maintenance period|||Percent reduction||Full Range|Least Squares Mean
745751|NCT00518713|Secondary|Percent Reduction in Number of Drop Seizures (Middle 4 Weeks of the 12-week Maintenance Period).|Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal.|4-week baseline period and the middle 4 weeks of the 12-week maintenance period|||Percent reduction||Full Range|Least Squares Mean
745752|NCT00518713|Secondary|Percent Reduction in Number of Drop Seizures (First 4 Weeks of the 12-week Maintenance Period).|Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal.|4-week baseline period and the first 4 weeks of the 12-week maintenance period|MITT population||Percent reduction||Full Range|Least Squares Mean
745753|NCT00518713|Primary|Percent Reduction in Number of Drop Seizures (12-week Maintenance Period).|Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal.|4-week baseline period and 12-week maintenance period|Modified Intent-to-Treat (MITT) population||Percent Reduction||Full Range|Least Squares Mean
745754|NCT00518882|Secondary|Hypoglyceamic Episodes, Weeks 26-78|Total number of hypoglycaemic episodes occurring after end of randomisation (week 26) and until week 78 (end of treatment). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|weeks 26-78|The safety analysis set is all subjects who had been exposed to at least one dose of the study products.||episodes|||Number
745755|NCT00518882|Secondary|Hypoglycaemic Episodes at Week 26|Total number of hypoglycaemic episodes occurring after baseline (week 0) and until week 26 (end of randomisation). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|weeks 0-26|The safety analysis set is all subjects who had been exposed to at least one dose of the study products.||episodes|||Number
745932|NCT00519649|Secondary|Number of Participants Reporting Unsolicited Adverse Events|An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|During the 31-day follow-up period after the challenge dose of HBV vaccine.|||participants|||Number
745756|NCT00518882|Secondary|Change in Apolipoprotein B at Week 78|Change in apolipoprotein B (ApoB) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.||g/L||Standard Deviation|Mean
745757|NCT00518882|Secondary|Change in Apolipoprotein B, Weeks 26-78|Change in apolipoprotein B (ApoB) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).|week 26, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.||g/L||Standard Deviation|Mean
745758|NCT00518882|Secondary|Change in Apolipoprotein B at Week 26|Change in apolipoprotein B (ApoB) from baseline (week 0) to 26 weeks (end of randomisation)|week 0, week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.||g/L||Standard Error|Least Squares Mean
745759|NCT00518882|Secondary|Change in Free Fatty Acid at Week 78|Change in Free Fatty Acid (FFA) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.||mmol/L||Standard Deviation|Mean
745760|NCT00518882|Secondary|Change in Free Fatty Acid, Weeks 26-78|Change in Free Fatty Acid (FFA) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).|week 26, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.||mmol/L||Standard Deviation|Mean
745761|NCT00518882|Secondary|Change in Free Fatty Acid at Week 26|Change in Free Fatty Acid (FFA) from baseline (week 0) to 26 weeks (end of randomisation)|week 0, week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.||mmol/L||Standard Error|Least Squares Mean
745762|NCT00518882|Secondary|Change in Triglyceride at Week 78|Change in triglyceride (TG) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.||mmol/L||Standard Deviation|Mean
745763|NCT00518882|Secondary|Change in Triglyceride, Weeks 26-78|Change in Triglyceride (TG) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).|week 26, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.||mmol/L||Standard Deviation|Mean
745764|NCT00518882|Secondary|Change in Triglyceride at Week 26|Change in triglyceride (TG) from from baseline (week 0) to 26 weeks (end of randomisation)|week 0, week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.||mmol/L||Standard Error|Least Squares Mean
745765|NCT00518882|Secondary|Change in High-density Lipoprotein-cholesterol at Week 78|Change in High-density Lipoprotein-cholesterol (HDL-C) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.||mmol/L||Standard Deviation|Mean
745766|NCT00518882|Secondary|Change in High-density Lipoprotein-cholesterol, Weeks 26-78|Change in High-density Lipoprotein-cholesterol (HDL-C) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).|week 26, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.||mmol/L||Standard Deviation|Mean
745767|NCT00518882|Secondary|Change in High-density Lipoprotein-cholesterol at Week 26|Change in High-density Lipoprotein-cholesterol (HDL-C) from baseline (week 0) to 26 weeks (end of randomisation)|week 0, week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.||mmol/L||Standard Error|Least Squares Mean
745768|NCT00518882|Secondary|Change in Very Low-density Lipoprotein-cholesterol at Week 78|Change in Very Low-density Lipoprotein-cholesterol (VLDL-C) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.||mmol/L||Standard Deviation|Mean
745769|NCT00518882|Secondary|Change in Very Low-density Lipoprotein-cholesterol, Weeks 26-78|Change in Very Low-density Lipoprotein-cholesterol (VLDL-C) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).|week 26, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.||mmol/L||Standard Deviation|Mean
745770|NCT00518882|Secondary|Change in Very Low-density Lipoprotein-cholesterol at Week 26|Change in very low-density lipoprotein-cholesterol (VLDL-C) from baseline (week 0) to 26 weeks (end of randomisation)|week 0, week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.||mmol/L||Standard Error|Least Squares Mean
747587|NCT00530842|Secondary|Static Lung Volumes (Percent)|Trough TGV/TLC (Thoracic Gas Volume over Total Lung Capacity) after 8 weeks (measured by bodyphlethysmography)|8 weeks|FAS using imputed values||Percent of TGV over TLC||Standard Error|Mean
745771|NCT00518882|Secondary|Change in Low-density Lipoprotein-cholesterol at Week 78|Change in Low-density Lipoprotein-cholesterol (LDL-C) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.||mmol/L||Standard Deviation|Mean
745772|NCT00518882|Secondary|Change in Low-density Lipoprotein-cholesterol, Weeks 26-78|Change in low-density lipoprotein-cholesterol (LDL-C) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).|week 26, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.||mmol/L||Standard Deviation|Mean
745773|NCT00518882|Secondary|Change in Low-density Lipoprotein-cholesterol at Week 26|Change in Low-density Lipoprotein-cholesterol (LDL-C) from baseline (week 0) to 26 weeks (end of randomisation)|week 0, week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.||mmol/L||Standard Error|Least Squares Mean
745774|NCT00518882|Secondary|Change in Total Cholesterol at Week 78|Change in total cholesterol (TC) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.||mmol/L||Standard Deviation|Mean
745775|NCT00518882|Secondary|Change in Total Cholesterol, Weeks 26-78|Change in total cholesterol (TC) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).|week 26, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the trial products.||mmol/L||Standard Deviation|Mean
745776|NCT00518882|Secondary|Change in Total Cholesterol at Week 26|Change in total cholesterol (TC) from baseline (week 0) to 26 weeks (end of randomisation)|week 0, week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.||mmol/L||Standard Error|Least Squares Mean
745777|NCT00518882|Secondary|Change in Beta-cell Function at Week 78|"Change in Beta-cell function from baseline (week 0) to 78 weeks (end of treatment). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B).
Beta-cell function: HOMA-B (%) = 20∙fasting insulin[uU/mL] divided by (FPG mmol/L]‑3.5)."|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.||percentage point (%point)||Standard Deviation|Mean
745778|NCT00518882|Secondary|Change in Beta-cell Function, Weeks 26-78|"Change in Beta-cell function from Week 26 (end of randomisation) to Week 78 (end of treatment). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B).
Beta-cell function: HOMA-B (%) = 20∙fasting insulin[uU/mL] divided by (FPG mmol/L]‑3.5)."|week 26, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.||percentage point (%point)||Standard Deviation|Mean
745779|NCT00518882|Secondary|Change in Beta-cell Function at Week 26|"Change in Beta-cell function from baseline (week 0) to 26 weeks (end of randomisation). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B).
Beta-cell function: HOMA-B (%) = 20∙fasting insulin[uU/mL] divided by (FPG mmol/L]‑3.5)."|week 0, week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.||percentage point (%point)||Standard Error|Least Squares Mean
745780|NCT00518882|Secondary|Change in Mean Postprandial Increment of Plasma Glucose After Dinner at Week 78|Change in mean postprandial increment of plasma glucose after dinner from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner.|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.||mmol/L||Standard Deviation|Mean
745781|NCT00518882|Secondary|Change in Mean Postprandial Increment of Plasma Glucose After Lunch at Week 78|Change in mean postprandial increment of plasma glucose after lunch from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch.|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.||mmol/L||Standard Deviation|Mean
745782|NCT00518882|Secondary|Change in Mean Postprandial Increment of Plasma Glucose After Breakfast at Week 78|Change in mean postprandial increment of plasma glucose after breakfast from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast.|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.||mmol/L||Standard Deviation|Mean
745933|NCT00519649|Secondary|Number of Participants Reporting Solicited General Symptoms|Solicited general symptoms assessed include fatigue, fever, gastrointestinal symptoms, and headache|During the 4-day follow-up period after the challenge dose of HBV vaccine.|||participants|||Number
782506|NCT00805766|Secondary|CDAI Remission Rates at Each Evaluation Time Point in the Increased Dose Period||every 4 weeks for up to 40 weeks||||||
745783|NCT00518882|Secondary|Change in Mean Postprandial Increment of Plasma Glucose After Dinner, Weeks 26-78|Change in mean postprandial increment of plasma glucose after dinner from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner.|week 26, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.||mmol/L||Standard Deviation|Mean
745784|NCT00518882|Secondary|Change in Mean Postprandial Increment of Plasma Glucose After Lunch, Weeks 26-78|Change in mean postprandial increment of plasma glucose after lunch from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch.|week 26, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.||mmol/L||Standard Deviation|Mean
745785|NCT00518882|Secondary|Change in Mean Postprandial Increment of Plasma Glucose After Breakfast, Weeks 26-78|Change in mean postprandial increment of plasma glucose after breakfast from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast.|week 26, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.||mmol/L||Standard Deviation|Mean
745786|NCT00518882|Secondary|Change in Mean Postprandial Increment of Plasma Glucose After Dinner at Week 26|Change in mean postprandial increment of plasma glucose after dinner from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner.|week 0, week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.||mmol/L||Standard Error|Least Squares Mean
745787|NCT00518882|Secondary|Change in Mean Postprandial Increment of Plasma Glucose After Lunch at Week 26|Change in mean postprandial increment of plasma glucose after lunch from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch.|week 0. week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.||mmol/L||Standard Error|Least Squares Mean
745788|NCT00518882|Secondary|Change in Mean Postprandial Increment of Plasma Glucose After Breakfast at Week 26|Change in mean postprandial increment of plasma glucose after breakfast from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast.|week 0, week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.||mmol/L||Standard Error|Least Squares Mean
745789|NCT00518882|Secondary|Change in Mean Prandial Increment of Plasma Glucose After Dinner at Week 78|Change in mean prandial increment of plasma glucose after dinner from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner.|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.||mmol/L||Standard Deviation|Mean
745790|NCT00518882|Secondary|Change in Mean Prandial Increment of Plasma Glucose After Lunch at Week 78|Change in mean prandial increment of plasma glucose after lunch from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch.|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.||mmol/L||Standard Deviation|Mean
745791|NCT00518882|Secondary|Change in Mean Prandial Increment of Plasma Glucose After Breakfast at Week 78|Change in mean prandial increment of plasma glucose after breakfast from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast.|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.||mmol/L||Standard Deviation|Mean
745792|NCT00518882|Secondary|Change in Mean Prandial Increment of Plasma Glucose After Dinner, Weeks 26-78|Change in mean prandial increment of plasma glucose after dinner from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner.|week 26, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.||mmol/L||Standard Deviation|Mean
745793|NCT00518882|Secondary|Change in Mean Prandial Increment of Plasma Glucose After Lunch, Weeks 26-78|Change in mean prandial increment of plasma glucose after lunch from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after a lunch.|week 26, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.||mmol/L||Standard Deviation|Mean
745794|NCT00518882|Secondary|Change in Mean Prandial Increment of Plasma Glucose After Breakfast, Weeks 26-78|Change in mean prandial increment of plasma glucose after breakfast from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast.|week 26, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.||mmol/L||Standard Deviation|Mean
745934|NCT00519649|Secondary|Number of Participants Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling|During the 4-day follow-up period after the challenge dose of HBV vaccine.|||participants|||Number
745795|NCT00518882|Secondary|Change in Mean Prandial Increment of Plasma Glucose After Dinner at Week 26|Change in mean prandial increment of plasma glucose after dinner from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner.|week 0, week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.||mmol/L||Standard Error|Least Squares Mean
745796|NCT00518882|Secondary|Change in Mean Prandial Increment of Plasma Glucose After Lunch at Week 26|Change in mean prandial increment of plasma glucose after lunch from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch.|week 0, week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.||mmol/L||Standard Error|Least Squares Mean
745797|NCT00518882|Secondary|Change in Mean Prandial Increment of Plasma Glucose After Breakfast at Week 26|Change in mean prandial increment of plasma glucose after breakfast from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between glucose values measured before and after breakfast.|week 0, week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.||mmol/L||Standard Error|Least Squares Mean
745798|NCT00518882|Secondary|Change in Fasting Plasma Glucose at Week 78|Change in fasting plasma glucose from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group)|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.||mmol/L||Standard Deviation|Mean
745799|NCT00518882|Secondary|Change in Fasting Plasma Glucose, Weeks 26-78|Change in fasting plasma glucose from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group)|week 26, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.||mmol/L||Standard Deviation|Mean
745800|NCT00518882|Secondary|Change in Fasting Plasma Glucose at Week 26|Change in fasting plasma glucose (FPG) from baseline (week 0) to 26 weeks (end of randomisation)|week 0, week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.||mmol/L||Standard Error|Least Squares Mean
745801|NCT00518882|Secondary|Change in Body Weight at Week 78|Change in body weight from baseline (Week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group)|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.||kg||Standard Deviation|Mean
745802|NCT00518882|Secondary|Change in Body Weight, Weeks 26-78|Change in body weight from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group)|week 26, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.||kg||Standard Deviation|Mean
745803|NCT00518882|Secondary|Change in Body Weight at Week 26|Change in body weight from baseline (week 0) to 26 weeks (end of randomisation)|week 0, week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.||kg||Standard Error|Least Squares Mean
745804|NCT00518882|Secondary|Percentage of Subjects Achieving Treatment Target of Either HbA1c < 7.0% or =< 6.5% at Week 78|Percentage of subjects achieving treatment target of HbA1c less than 7.0% or less than or equal to 6.5% at Week 78 (end of treatment)|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.||percentage (%) of subjects|||Number
745805|NCT00518882|Secondary|Percentage of Subjects Achieving Treatment Target of Either HbA1c < 7.0% or =< 6.5% at Week 26|Percentage of subjects achieving treatment target of HbA1c less than 7.0% or less than or equal to 6.5% at Week 26 (end of randomisation)|week 0, week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.||percentage (%) of subjects|||Number
745806|NCT00518882|Secondary|Change in Glycosylated A1c (HbA1c) at Week 78|Percentage point change in glycosylated A1c (HbA1c) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group)|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.||percentage point of total HbA1c||Standard Deviation|Mean
745807|NCT00518882|Secondary|Change in Glycosylated A1c (HbA1c), Weeks 26-78|Percentage point change in glycosylated A1c (HbA1c) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group)|week 26, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.||percentage point of total HbA1c||Standard Deviation|Mean
745808|NCT00518882|Primary|Change in Glycosylated A1c (HbA1c) at Week 26|Percentage point change in glycosylated A1c (HbA1c) from baseline (week 0) to 26 weeks (end of randomisation)|week 0, week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.||percentage point of total HbA1c||Standard Error|Least Squares Mean
745916|NCT00519532|Primary|Change From Baseline in UPDRS III Score at Week 13 (End of Maintenance)|"The Unified Parkinson´s Disease Rating Scale Part III is an accepted and validated scale for the assessment of motor function in Parkinson´s disease. Each of the elements in the UPDRS III is measured on a scale of 0 to 4, where 0 is normal and 4 represents severe abnormalities.
Baseline is defined as first titration visit (T1) of SP915."|Baseline (baseline SP915) and week 13 (End of maintenance)|Full Analysis Set (FAS).||units on a scale||Standard Deviation|Mean
745809|NCT00518986|Secondary|Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at 12 Weeks|"Cephalon created the Excessive Sleepiness Symptom Rating Form to assess symptoms of excessive sleepiness. Patients rate 7 symptoms(Tiredness, Fatigue, Sleepiness, Lack of energy, Trouble paying attention, Forgetfulness, Trouble staying organized) each on an 11-point Likert scale(0=no problem at all 10=as bad as you can imagine). ES Symptom Rating Form was designed to follow the response to treatment (measuring severity) of each of these 7 symptoms using the same 11-point scale. Change from Baseline to 12 Weeks is presented only for the symptom of Sleepiness."|Baseline and 12 weeks following start of study drug administration|Full analysis set defined as subjects who completed the ES Symptom Rating Form at baseline and at 12 weeks||Units on a scale||Standard Error|Least Squares Mean
745810|NCT00518986|Secondary|Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at 8 Weeks|"Cephalon created the Excessive Sleepiness Symptom Rating Form to assess symptoms of excessive sleepiness. Patients rate 7 symptoms(Tiredness, Fatigue, Sleepiness, Lack of energy, Trouble paying attention, Forgetfulness, Trouble staying organized) each on an 11-point Likert scale(0=no problem at all 10=as bad as you can imagine). ES Symptom Rating Form was designed to follow the response to treatment (measuring severity) of each of these 7 symptoms using the same 11-point scale. Change from Baseline to 8 Weeks is presented only for the symptom of Sleepiness."|baseline and 8 weeks following start of study drug administration|Full analysis set defined as subjects who completed the ES Symptom Rating Form at baseline and at 8 weeks||Units on a scale||Standard Error|Least Squares Mean
745811|NCT00518986|Secondary|Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at 4 Weeks|"Cephalon created the Excessive Sleepiness Symptom Rating Form to assess symptoms of excessive sleepiness. Patients rate 7 symptoms(Tiredness, Fatigue, Sleepiness, Lack of energy, Trouble paying attention, Forgetfulness, Trouble staying organized) each on an 11-point Likert scale(0=no problem at all 10=as bad as you can imagine). ES Symptom Rating Form was designed to follow the response to treatment (measuring severity) of each of these 7 symptoms using the same 11-point scale. Change from Baseline to 4 Weeks is presented only for the symptom of Sleepiness."|Baseline and 4 weeks following start of study drug administration|Full analysis set defined as subjects who completed the ES Symptom Rating Form at Baseline and at 4 weeks||Units on a scale||Standard Error|Least Squares Mean
745812|NCT00518986|Secondary|Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at 2 Weeks|"Cephalon created the Excessive Sleepiness Symptom Rating Form to assess symptoms of excessive sleepiness. Patients rate 7 symptoms(Tiredness, Fatigue, Sleepiness, Lack of energy, Trouble paying attention, Forgetfulness, Trouble staying organized) each on an 11-point Likert scale(0=no problem at all 10=as bad as you can imagine). ES Symptom Rating Form was designed to follow the response to treatment (measuring severity) of each of these 7 symptoms using the same 11-point scale. Change from Baseline to 2 Weeks is presented only for the symptom of Sleepiness."|Baseline and 2 weeks|Full analysis set defined as subjects who completed the ES Symptom Rating form at baseline and 2 weeks||Units on a scale||Standard Error|Least Squares Mean
745813|NCT00518986|Secondary|Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at Endpoint (12 Weeks or Last Observation After Baseline)|"The Excessive Sleepiness Symptom Rating Form was used to assess symptoms of excessive sleepiness. Patients rate 7 symptoms(tiredness, fatigue, sleepiness, lack of energy, trouble paying attention, forgetfulness, trouble staying organized) on an 11-point Likert scale (0 = no problem at all to 10 = as bad as you can imagine). ES Symptom Rating Form was designed to follow the response to treatment measuring severity of each of these 7 symptoms using the same 11-point scale. Change from Baseline to Endpoint (12 weeks or last baseline observation) is presented only for the symptom of Sleepiness."|Baseline and Endpoint (12 weeks or last observation after baseline)|Full analysis set defined as subjects with at least one observation after baseline||Units on a scale||Standard Error|Least Squares Mean
745814|NCT00518986|Secondary|Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at 12 Weeks|"The MOS-CF6 assesses self-reported cognitive function. Items were selected to cover 6 relevant aspects of cognitive functioning as follows: confusion, concentration/thinking, attention, memory, reasoning, problem-solving, and processing speed. The MOS-CF6 responses includes 6 choices, ranging from none of the time to all of the time. The MOS-CF6 is scored by summing responses across the 6 items and converting the total to a 0 - 100 point scale, with the higher score indicating better cognitive functioning. Data is presented showing the change in score from baseline to 12 weeks."|baseline and 12 weeks following start of study drug administration|Full analysis set defined as subjects who completed MOS-CF6 at baseline and at 12 weeks||Units on a scale||Standard Error|Least Squares Mean
745815|NCT00518986|Secondary|Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at 8 Weeks|"The MOS-CF6 assesses self-reported cognitive function. Items were selected to cover 6 relevant aspects of cognitive functioning as follows: confusion, concentration/thinking, attention, memory, reasoning, problem-solving, and processing speed. The MOS-CF6 responses includes 6 choices, ranging from none of the time to all of the time. The MOS-CF6 is scored by summing responses across the 6 items and converting the total to a 0 - 100 point scale, with the higher score indicating better cognitive functioning. Data is presented showing the change in score from baseline to 8 weeks."|baseline and 8 weeks following start of study drug administration|Full analysis set defined as subjects who completed the MOS-CF6 at baseline and at week 8||Units on a scale||Standard Error|Least Squares Mean
745816|NCT00518986|Secondary|Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at 4 Weeks|"The MOS-CF6 assesses self-reported cognitive function. Items were selected to cover 6 relevant aspects of cognitive functioning as follows: confusion, concentration/thinking, attention, memory, reasoning, problem-solving, and processing speed. The MOS-CF6 responses includes 6 choices, ranging from none of the time to all of the time. The MOS-CF6 is scored by summing responses across the 6 items and converting the total to a 0 - 100 point scale, with the higher score indicating better cognitive functioning. Data is presented showing the change in score from baseline to 4 weeks."|baseline and 4 weeks following start of study drug administration|Full analysis set defined as subjects who completed the MOS-CF6 at baseline and at 4 weeks||Units on a scale||Standard Error|Least Squares Mean
745917|NCT00519584|Secondary|Total Opioid Consumption|cumulative opioid consumption in oral oxycodone equivalents (mg) during the first 3 days after surgery.|during first 3 days after surgery|||mg||Inter-Quartile Range|Median
745978|NCT00520234|Secondary|Incidence of Proven and Probable Invasive Fungal Infections Other Than Invasive Candidiasis.||Within 7 days after end of therapy||||||
745817|NCT00518986|Secondary|Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at 2 Weeks|"The MOS-CF6 assesses self-reported cognitive function. Items were selected to cover 6 relevant aspects of cognitive functioning as follows: confusion, concentration/thinking, attention, memory, reasoning, problem-solving, and processing speed. The MOS-CF6 responses includes 6 choices, ranging from none of the time to all of the time. The MOS-CF6 is scored by summing responses across the 6 items and converting the total to a 0 - 100 point scale, with the higher score indicating better cognitive functioning. Data is presented showing the change in score from baseline to 2 weeks."|baseline and 2 weeks|Full analysis set defined as subjects who completed the MOS-CF6 at baseline and at 2 weeks||Units on a scale||Standard Error|Least Squares Mean
745818|NCT00518986|Secondary|Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at Endpoint (12 Weeks or Last Observation After Baseline)|"The MOS-CF6 assesses self-reported cognitive function. Items were selected to cover 6 relevant aspects of cognitive functioning:confusion, concentration/thinking, attention, memory, reasoning, problem-solving, and processing speed. Responses range from none of the time to all of the time. The MOS-CF6 is scored by summing responses across the 6 items and converting the total to a 0 - 100 point scale, with the higher score indicating better cognitive functioning. Data is presented showing the change in score from baseline to Endpoint (12 weeks or last observation after baseline)."|Baseline and Endpoint (12 weeks or last observation after baseline)|Full analysis set defined as subjects who had at least one observation after baseline||Units on a scale||Standard Error|Least Squares Mean
745819|NCT00518986|Secondary|Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) at Week 12|The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum = 2 maximum = 120) was calculated from the responses. A responder analysis defining responders as patients with a total score > 17.9 at 12 weeks is presented here.|12 weeks following the start of study drug administration|Full analysis set defined as subjects who completed the FOSQ at 12 weeks||Participants|||Number
745820|NCT00518986|Secondary|Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) at Week 8|The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score was calculated from the responses (minimum = 2 maximum = 120). A responder analysis defining responders as patients with a total score > 17.9 at 8 weeks is presented here.|8 weeks following start of study drug administration|Full analysis set defined as subjects who completed the FOSQ at 8 weeks||Participants|||Number
745821|NCT00518986|Secondary|Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) at Week 4|The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum=2 maximum = 120) was calculated from the responses. A responder analysis defining responders as patients with a total score > 17.9 at 4 weeks is presented here.|4 weeks following start of study drug administration|Full analysis set defined as subjects who completed the FOSQ at 4 weeks||Participants|||Number
745822|NCT00518986|Secondary|Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 2 Weeks|The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum=2 maximum=120) was calculated from the responses. A responder analysis defining responders as patients with a total score > 17.9 at 2 weeks is presented here.|2 weeks following start of study drug administration|Full analysis set defined as subject who completed the FOSQ at 2 weeks||Participants|||Number
745823|NCT00518986|Secondary|Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at Endpoint (Week 12 or Last Observation After Baseline)|The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum = 2 maximum = 120) was calculated from the responses. A responder analysis defining responders as patients with a total score > 17.9 at Endpoint (12 weeks or last observation after baseline) is presented.|Endpoint (week 12 or last observation after baseline)|Full analysis set defined as subjects with at least one observation after baseline||Participants|||Number
745824|NCT00518986|Secondary|Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 12 Weeks|The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum = 2 maximum = 120) was calculated from the responses. The change in total score from baseline to 12 weeks is presented here.|baseline and 12 weeks following the start of study drug administration|Full analysis set defined as subjects who completed the FOSQ at baseline and at 12 weeks||Units on a scale||Standard Error|Least Squares Mean
745825|NCT00518986|Secondary|Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 8 Weeks|The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum = 2 maximum = 120) was calculated from the responses. The change in total score from baseline to 8 weeks is presented here.|baseline and 8 weeks following start of study drug administration|Full analysis set defined as subjects who completed the FOSQ at baseline and at 8 weeks||Units on a scale||Standard Error|Least Squares Mean
745979|NCT00520234|Secondary|Time to Development of Proven or Probable Invasive Candidiasis||Within 7 days after end of therapy||||||
745980|NCT00520234|Secondary|Initiation of Other Antifungals||Within 7 days after end of therapy||||||
745981|NCT00520234|Secondary|All Cause Mortality||Within 7 days of end of therapy||||||
745826|NCT00518986|Secondary|Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 4 Weeks|The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum = 2 maximum = 120) was calculated from the responses. The change in total score from baseline to 4 weeks is presented here.|baseline and 4 weeks following start of study drug administration|Full analysis set defined as subjects who completed the FOSQ at baseline and at 4 weeks||Units on a scale||Standard Error|Least Squares Mean
745827|NCT00518986|Secondary|Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 2 Weeks|The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum = 2 maximum = 120) was calculated from the responses. The change in total score from baseline to 2 weeks is presented here.|baseline and 2 weeks following start of study drug administration|Full analysis set defined as subjects who completed FOSQ at baseline and at 2 weeks||Units on a scale||Standard Error|Least Squares Mean
745828|NCT00518986|Secondary|Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at Endpoint (12 Weeks or Last Observation After Baseline)|The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum of 2 maximum of 120) was calculated from the responses. The change in total score from baseline to Endpoint (12 weeks or last observation after baseline) is presented here.|Baseline and endpoint (12 weeks after start of study drug or last observation after baseline)|Full analysis set defined as subjects who had at least one observation after baseline||Units on a scale||Standard Error|Least Squares Mean
745829|NCT00518986|Secondary|Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 12 Weeks (or Last Observation After Baseline)|The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The Interference Score consists of 6 questions that ask subjects to rate on a 0 to 10 scale how during the past 24 hours fatigue has interfered with their general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life. The scores are averaged (0-10) for the Interference Score.|Baseline and 12 weeks after start of study drug administration|Full analysis set defined as subjects who completed BFI at baseline and at 12 weeks||Units on a scale||Standard Error|Least Squares Mean
745830|NCT00518986|Secondary|Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 8 Weeks|The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The Interference Score consists of 6 questions that ask subjects to rate on a 0 to 10 scale how during the past 24 hours fatigue has interfered with their general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life. The scores are averaged (0-10) for the Interference Score.|Baseline and 8 weeks after start of study drug administration|Full analysis set defined as subjects who completed the BFI at baseline and at 8 weeks||Units on a scale||Standard Error|Least Squares Mean
745831|NCT00518986|Secondary|Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 4 Weeks|The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The Interference Score consists of 6 questions that ask subjects to rate on a 0 to 10 scale how during the past 24 hours fatigue has interfered with their general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life. The scores are averaged (0-10) for the Interference Score.|Baseline and 4 weeks after start of study drug administration|Full analysis set defined as subjects who completed the BFI at baseline and at 4 weeks||Units on a scale||Standard Error|Least Squares Mean
745832|NCT00518986|Secondary|Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 2 Weeks|The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The Interference Score consists of 6 questions that ask subjects to rate on a 0 to 10 scale how during the past 24 hours fatigue has interfered with their general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life. The scores are averaged (0-10) for the Interference Score.|Baseline and 2 weeks after start of study drug administration|Full analysis set defined as subjects who completed the BFI at baseline and at 2 weeks||Units on a scale||Standard Error|Least Squares Mean
745833|NCT00518986|Secondary|Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at Endpoint (12 Weeks or Last Observation After Baseline)|The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The Interference Score consists of 6 questions that ask subjects to rate on a 0 to 10 scale how during the past 24 hours fatigue has interfered with their general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life. The scores are averaged (0-10) for the Interference Score.|Baseline and at endpoint (12 weeks or last observation after baseline)|Full analysis set defined as subjects who had at least one observation after baseline||Units on a scale||Standard Error|Least Squares Mean
745853|NCT00518986|Secondary|Change From Baseline on Epworth Sleepiness Scale (ESS) at 12 Weeks|ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The change in ESS total score from baseline to 12 weeks are summarized.|12 weeks (or last observation after baseline)|Full analysis set defined as subjects who completed ESS at Baseline and at 12 weeks||Units on a scale||Standard Error|Least Squares Mean
745834|NCT00518986|Secondary|Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 12 Weeks|The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. Subjects were considered responders if the final Worst Fatigue Score was < 7 at Week 12.|12 weeks after start of study drug administration|Full analysis set defined as subjects who completed the BFI at 12 weeks||Participants|||Number
745835|NCT00518986|Secondary|Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 8 Weeks|The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. Subjects were considered responders if the final Worst Fatigue Score was < 7 at Week 8.|8 weeks after start of study drug administration|Full analysis set defined as subjects who completed the BFI at 8 weeks||Participants|||Number
745836|NCT00518986|Secondary|Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 4 Weeks|The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. Subjects were considered responders if the final Worst Fatigue Score was < 7 at Week 4.|4 weeks after start of study drug administration|Full analysis set defined as subjects who completed BFI at 4 weeks||Participants|||Number
745837|NCT00518986|Secondary|Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 2 Weeks|The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. Subjects were considered responders if the final Worst Fatigue Score was < 7 at Week 2.|2 weeks after start of study drug administration|Full analysis set defined as subjects who completed BFI at 2 weeks||Participants|||Number
745838|NCT00518986|Secondary|Number of Responders According to Brief Fatigue Inventory (BFI) Worst Fatigue Score at Endpoint (12 Weeks or Last Observation After Baseline)|The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. Subjects were considered responders if the final Worst Fatigue Score was < 7 at Week 12 or last observation after baseline.|12 weeks after start of study drug administration (or last observation after baseline)|Full analysis set defined as subjects who had at least one observation after baseline||Participants|||Number
745839|NCT00518986|Secondary|Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 12 Weeks|The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. This measure compares the change in score from baseline to Week 12.|12 weeks|||Units on a scale||Standard Error|Least Squares Mean
745840|NCT00518986|Secondary|Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 8 Weeks|The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. This measure compares the change in score from baseline to Week 8.|Baseline and 8 weeks after start of study drug administration|Full analysis set defined as subjects who completed the BFI at baseline and at week 8||Units on a scale||Standard Error|Least Squares Mean
745841|NCT00518986|Secondary|Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 4 Weeks|The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. This measure compares the change in score from baseline to Week 4.|Baseline and 4 weeks after start of study drug administration|Full analysis set defined as subjects who completed BFI at baseline and at 4 weeks||Units on a scale||Standard Error|Least Squares Mean
745842|NCT00518986|Secondary|Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 2 Weeks|The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. This measure compares the change in score from baseline to Week 2.|Baseline and 2 weeks after start of study drug administration|Full analysis set defined as subjects who completed BFI at baseline and at 2 weeks||Units on a scale||Standard Error|Least Squares Mean
745843|NCT00518986|Secondary|Change From Baseline on the Brief Fatigue Inventory (BFI) Worst Daily Fatigue Score at Endpoint (12 Weeks or Last Observation After Baseline)|The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with >= 7 indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. This measure compares the change in score from baseline to Week 12 (or last observation after baseline).|Baseline and 12 weeks or last observation after baseline|Full analysis set defined as subjects with at least one observation after baseline||Units on a scale||Standard Error|Least Squares Mean
745844|NCT00518986|Secondary|Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 12 Weeks|The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The total score is calculated by taking the sum of all 9 rating scales for a minimum score of 0 and a maximum score of 90. This assessment examines the difference in total BFI score from Baseline to 12 weeks.|Baseline and 12 weeks after start of study drug administration|||Units on a scale||Standard Error|Least Squares Mean
745845|NCT00518986|Secondary|Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 8 Weeks|The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The total score is calculated by taking the sum of all 9 rating scales for a minimum score of 0 and a maximum score of 90. This assessment examines the difference in total BFI score from Baseline to 8 weeks.|Baseline and 8 weeks after start of study drug administration|||Units on a scale||Standard Error|Least Squares Mean
745846|NCT00518986|Secondary|Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 4 Weeks|The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The total score is calculated by taking the sum of all 9 rating scales for a minimum score of 0 and a maximum score of 90. This assessment examines the difference in total BFI score from Baseline to 4 weeks.|Baseline and 4 weeks after start of study drug administration|Full analysis set defined as subjects who had completed BFI at baseline and at 4 weeks||Units on a scale||Standard Error|Least Squares Mean
745847|NCT00518986|Secondary|Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 2 Weeks|The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The total score is calculated by taking the sum of all 9 rating scales for a minimum score of 0 and a maximum score of 90. This assessment examines the difference in total BFI score from Baseline to 2 weeks.|Baseline and 2 weeks after start of study drug administration|Full analysis set defined as subjects who had completed BFI at baseline and at 2 weeks||Units on a scale||Standard Error|Least Squares Mean
745848|NCT00518986|Secondary|Change From Baseline to Endpoint (Week 12 or Last Observation After Baseline) in the Brief Fatigue Inventory (BFI) Total Score|The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The total score is calculated by taking the sum of all 9 rating scales for a minimum score of 0 and a maximum score of 90. This assessment examines the difference in total BFI score from Baseline to 12 weeks or last observation after baseline.|Baseline and 12 weeks following start of study drug administration or last recorded observation|Full analysis set defined as subjects with at least one BFI assessment after baseline||Units on a scale||Standard Error|Least Squares Mean
745849|NCT00518986|Secondary|Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 12 Weeks|ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The number of responders who had a total ESS score < 10 and the number of non-responders with a total score >= 10 at 12 weeks are presented.|12 weeks|Full analysis set defined as subjects who completed the ESS at 12 weeks||Participants|||Number
745850|NCT00518986|Secondary|Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 8 Weeks|ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The number of responders who had a total ESS score < 10 and the number of non-responders with a total score >= 10 at 8 weeks are presented.|8 weeks|Full analysis set defined as subjects who completed ESS at 8 weeks||Participants|||Number
745851|NCT00518986|Secondary|Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 4 Weeks|ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The number of responders who had a total ESS score < 10 and the number of non-responders with a total score >= 10 at 4 weeks are presented.|4 weeks|Full analysis set defined as number of subjects who completed ESS at 4 weeks||Participants|||Number
745852|NCT00518986|Secondary|Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 2 Weeks|ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The number of responders who had a total ESS score < 10 and the number of non-responders with a total score >= 10 at 2 weeks are presented.|2 weeks|Full analysis set defined as the number of subjects who completed the ESS at 2 weeks||Participants|||Number
745854|NCT00518986|Secondary|Change From Baseline on Epworth Sleepiness Scale (ESS) at 8 Weeks|ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The change in ESS total score from baseline to 8 weeks are summarized.|Baseline and 8 weeks after start of study drug administration|Full analysis set defined as subjects who completed ESS at Baseline and at 8 weeks||Units on a scale||Standard Error|Least Squares Mean
745855|NCT00518986|Secondary|Change From Baseline on Epworth Sleepiness Scale (ESS) at 4 Weeks|ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The change in ESS total score from baseline to 4 weeks are summarized.|Baseline and 4 weeks after start of study drug administration|Full analysis set defined as subjects who completed ESS at baseline and at Week 4||Units on a scale||Standard Error|Least Squares Mean
745856|NCT00518986|Secondary|Change From Baseline on Epworth Sleepiness Scale (ESS) at 2 Weeks|ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The change in ESS total score from baseline to two weeks are summarized.|Baseline and 2 weeks following start of study drug administration|Full analysis set defined as subjects who completed the ESS at baseline and at 2 weeks||Unit on a scale||Standard Error|Least Squares Mean
745857|NCT00518986|Secondary|Clinical Global Impression of Change (CGI-C) at 12 Weeks - Full Scale|The CGI-C is a clinician's rating of disease severity compared with baseline as assessed by Clinical Global Impression of Severity (CGI-S). CGI-C rates 7 responses: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. CGI-S measured 7 categories as well: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among most extremely ill. The results for the number of participants who responded to each item on the full scale at 12 weeks are presented.|12 weeks after starting study drug treatment|Full analysis set defined as subjects assessed by CGI-C at 12 weeks||Participants|||Number
745858|NCT00518986|Secondary|Clinical Global Impression of Change (CGI-C) at 8 Weeks - Full Scale|The CGI-C is a clinician's rating of disease severity compared with baseline as assessed by Clinical Global Impression of Severity (CGI-S). CGI-C rates 7 responses: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. CGI-S measured 7 categories as well: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among most extremely ill. The results for the number of participants who responded to each item on the full scale at 8 weeks are presented.|8 weeks after start of study drug treatment|Full analysis set defined as subjects who were assessed by CGI-C at 8 weeks||Participants|||Number
745859|NCT00518986|Secondary|Clinical Global Impression of Change (CGI C) at 4 Weeks - Full Scale|The CGI-C is a clinician's rating of disease severity compared with baseline as assessed by Clinical Global Impression of Severity (CGI-S). CGI-C rates 7 responses: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. CGI-S measured 7 categories as well: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among most extremely ill. The results for the number of participants who responded to each item on the full scale at 4 weeks are presented.|4 weeks after start of treatment|Full analysis set defined as subjects who were assessed by CGI-C at 4 weeks.||Participants|||Number
745860|NCT00518986|Secondary|Clinical Global Impression of Change (CGI-C) at 12 Weeks|The CGI-C is a clinician's rating of disease severity compared with baseline as assessed by Clinical Global Impression of Severity (CGI-S). CGI-C rates 7 responses: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. CGI-S measured 7 categories as well: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among most extremely ill. Proportion of responders who had at least minimal improvement in CGI-C ratings (as related to sleepiness) were assessed.|12 weeks after beginning treatment|Full analysis set defined as subjects assessed with CGI-C at week 12||Participants|||Number
745861|NCT00518986|Secondary|Clinical Global Impression of Change (CGI-C) at 8 Weeks|"The CGI-C is a clinician's rating of disease severity compared with baseline as assessed by Clinical Global Impression of Severity (CGI-S). CGI-C rates 7 responses: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. CGI-S measured 7 categories as well: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among most extremely ill. Proportion of responders who had at least minimally improved in CGI-C ratings (as related to sleepiness) at 8 weeks were assessed."|8 weeks after beginning study drug treatment|Full analysis set defined as subjects assessed by CGI-C at 8 weeks||Participants|||Number
745862|NCT00518986|Secondary|Clinical Global Impression of Change (CGI-C) at 4 Weeks|"The CGI-C is a clinician's rating of disease severity compared with baseline as assessed by Clinical Global Impression of Severity (CGI-S). CGI-C rates 7 responses: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. CGI-S measured 7 categories as well: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among most extremely ill. Proportion of responders who had at least minimally improved in CGI-C ratings (as related to sleepiness) at 4 weeks were assessed."|4 weeks after beginning study drug treatment|Full analysis set defined as subjects who were assessed with CGI-C at 4 weeks||Participants|||Number
745863|NCT00518986|Secondary|Change From Baseline on Maintenance of Wakefulness Test (MWT) at 12 Weeks|MWT measures ability of subject to remain awake. Subjects instructed to try and remain awake during series of four 30-minute periods (0900, 1100, 1300, and 1500) reclining in dark room. Each period was terminated immediately after sleep onset or at end of 30 minutes if no sleep occured. If subject fell asleep, they were awakened and not allowed to sleep for remainder of that 30 minute period. Change from Baseline to 12 weeks in mean sleep latency (measured in minutes)averaged from each of the four testing intervals was measured. The poorest outcome was 0 minutes the best was 30 minutes.|baseline and 12 weeks (or last observation after baseline)|Full analysis set defined as subjects who had measurements of MWT at baseline and 12 weeks.||Minutes||Standard Error|Least Squares Mean
745982|NCT00520234|Secondary|Incidence of Proven Invasive Candidiasis by MSG/ EORTC Criteria.||Within 7 days of end of therapy||||||
745864|NCT00518986|Secondary|Change From Baseline on Maintenance of Wakefulness Test (MWT) at 8 Weeks|MWT measures ability of subject to remain awake. Subjects instructed to try and remain awake during series of four 30-minute periods (0900, 1100, 1300, and 1500) reclining in dark room. Each period was terminated immediately after sleep onset or at end of 30 minutes if no sleep occured. If subject fell asleep, they were awakened and not allowed to sleep for remainder of that 30 minute period. Change from Baseline to 8 weeks in mean sleep latency (measured in minutes)averaged from each of the four testing intervals was measured. The poorest outcome was 0 minutes the best was 30 minutes.|Baseline and 8 weeks following start of study drug administration|Full analysis set defined as subjects with MWT measure at 8 weeks and baseline||Minutes||Standard Error|Least Squares Mean
745865|NCT00518986|Secondary|Change From Baseline on Maintenance of Wakefulness Test (MWT) at 4 Weeks|MWT measures ability of subject to remain awake. Subjects instructed to try and remain awake during series of four 30-minute periods (0900, 1100, 1300, and 1500) reclining in dark room. Each period was terminated immediately after sleep onset or at end of 30 minutes if no sleep occured. If subject fell asleep, they were awakened and not allowed to sleep for remainder of that 30 minute period. Change from Baseline to 4 weeks in mean sleep latency (measured in minutes)averaged from each of the four testing intervals was measured. The poorest outcome was 0 minutes the best was 30 minutes.|baseline and 4 weeks|Full analysis set defined as subjects who had MWT measurement at baseline and at 4 weeks||Minutes||Standard Error|Least Squares Mean
745866|NCT00518986|Secondary|Change From Baseline on the Epworth Sleepiness Scale (ESS) at Endpoint (12 Weeks or Last Measurement After Baseline)|For this key secondary outcome the ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The change in ESS total score from baseline to Endpoint (12 weeks or last observation after baseline) are summarized.|Baseline and 12 weeks (or last observation after baseline)|Full analysis set defined as subjects who had at least one assessment of ESS after baseline||Units on a scale||Standard Error|Least Squares Mean
745867|NCT00518986|Primary|Clinical Global Impression of Change (CGI-C) at Endpoint (12-weeks or Last Observation After Baseline)|"The CGI-C is a clinician's rating of disease severity compared with baseline as assessed by Clinical Global Impression of Severity (CGI-S). CGI-C rates improvement by 7 categories: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. CGI-S measured 7 categories of illness as well: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among most extremely ill. Proportion of responders who had at least minimally improved in CGI-C ratings (as related to sleepiness) were assessed."|12 weeks (or last observation after baseline)|Full analysis set which includes subjects who had at least 1 measurement of MWT or CGI-C after baseline.||Participants|||Number
745868|NCT00518986|Primary|Change From Baseline on Maintenance of Wakefulness Test (MWT) to Endpoint (12 Weeks or Last Observation After Baseline)|MWT measures ability of subject to remain awake. Subjects instructed to try and remain awake during series of 4 30-minute periods (0900, 1100, 1300, and 1500) reclining in dark room. Each period was terminated immediately after sleep onset or at end of 30 minutes if no sleep occurred. If subject fell asleep, they were awakened and not allowed to sleep for remainder of that 30 minute period. Change from Baseline to Endpoint (12 weeks or last observation after baseline) in mean sleep latency averaged from the 4 intervals was measured. Poorest outcome was 0 minutes the best was 30 minutes.|Baseline and 12 weeks (or last observation after baseline)|Full analysis set which includes subjects who had at least 1 measurement of MWT or Clinical Global Impression of Change (CGI-C) after baseline.||Minutes||Standard Deviation|Mean
745869|NCT00519077|Secondary|Median Progression-free Survival Time|Progression-free survival (PFS) is the number of months during and after Gefitinib treatment during which the cancer did not get worse (progress) as defined by Response Evaluation Criteria In Solid Tumors (RECIST). Progressive disease is associated with at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. All patients developed progressive disease or died during the 9-month observation period.|9 months|||months||95% Confidence Interval|Median
745870|NCT00519077|Primary|Response (CR or PR), Stable Disease (SD), and Progressive Disease (PD) Rates|"The proportion of subjects that responded [complete (CR) or partial response (PR)], had stable disease (SD), or progressive disease (PD) as defined by the Response Evaluation Criteria In Solid Tumors (RECIST)
Complete Response (CR): Disappearance of all target lesions
Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter
Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter (LD) since the treatment started
Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions"|8 weeks|Eight patients were not assessable for response, six of them died prior to the evaluation of response. For the purpose of the analysis these patients were classified as having disease progression in response to therapy.||percentage of participants|||Number
745871|NCT00519090|Secondary|Durable Complete Cytogenetic Response Rate|Due to early termination of the trial, the number of patients was too small and imbalanced and therefore analysis was not performed.|24 months|The trial was terminated early, so only 6 patients were enrolled.||percent of participants|||Number
745872|NCT00519090|Primary|Complete Cytogenetic Response Rate(CCyR) in Patients Who Had a Suboptimal Cytogenetic Response on Imatinib|Due to early termination of the trial, the number of patients was too small and imbalanced and therefore analysis was not performed.|12 months|||percent of participants|||Number
745873|NCT00519194|Primary|Freedom From Atrial Fibrillation in the Absence of Any AF Therapies|Freedom from atrial fibrillation (AF) at 6 months in absence of any AF therapies.|6 months|||participants|||Number
745918|NCT00519584|Secondary|Maximum VRS Pain Scores at Rest|Verbal rating scales (VRS): a list of adjectives describing different levels of pain intensity with 0 = no pian and 10 = extremely intense pain. An adequate VRS of pain intensity should include adjectives that reflect the extremes of this dimension; from 'no pain' to 'extremely intense pain'. Patients are asked to read over the list of adjectives and select the word or phrase that best describes their level of pain on the scale from 0 to 10.|postoperative day 1 day 2, day 3.|||units on a scale||Inter-Quartile Range|Median
745874|NCT00519285|Secondary|Number of Participants With Positive Anti-aflibercept Antibody Levels as a Measure of Immunogenicity of Aflibercept|"Serum for detection of anti-drug antibodies (ADA) was collected in patients treated in selected centers only. Samples were analyzed using a titer-based, bridging immunoassay developed and validated to detect ADAs in human serum.
Samples with positive antibody levels were further analyzed using a validated, non-quantitative ligand binding assay to detect neutralizing antibodies Ab).
A participant was considered to have positive antibody levels if antibodies were detected above the quantification limits."|Pre-dose of cycle 1 (baseline), pre-dose of each every other cycle, then 30 and 90 days after the last administration of the study drug|The analysis was performed on the safety population evaluable for immunogenicity (i.e. exposed to aflibercept with serum samples evaluable for immunogenicity).||participants|||Number
745875|NCT00519285|Secondary|Number of Participants With Adverse Events as a Measure of Safety|"Adverse Events (AE) are any unfavorable and unintended sign, symptom, syndrome or illness observed by the investigator or reported by the participant during the study.
AE were collected at regular intervals throughout the study then graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v.3.0)."|From first dose of study treatment (aflibercept/placebo or docetaxel whichever came first) to last dose of study treatment (aflibercept/placebo or docetaxel whichever came last) + 30 days|The analysis was performed on the safety population (i.e. all randomized and treated participants according to the treatment actually received). Six participants in the Placebo group who received at least one dose of aflibercept in error were considered in the Aflibercept group.||participants|||Number
745876|NCT00519285|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Prostate Total Score as a Measure of Health Related Quality of Life|"Functional Assessment of Cancer Therapy-Prostate (FACT-P) is a 39-item participant questionnaire that measures the concerns of patients with prostate cancer. It consists of 5 subscales assessing physical well-being, social/family well-being, emotional well-being, functional well-being, and prostate-specific concerns.
FACT-P total score is the sum of the 5 subscores. It ranges from 0 to 156 with higher score indicating better quality of life."|Before randomization (baseline) then every 3 weeks until disease progression or administration of further antitumor therapy, whichever came first|The analysis was performed on the ITT population evaluable for Health related quality of life (i.e. with baseline and at least one post-baseline evaluable FACT-P questionnaire).||units on a scale||Standard Deviation|Mean
745877|NCT00519285|Secondary|Pain Response Rate|Pain response was defined as either a ≥2-point decrease from baseline in Present Pain Intensity (PPI) score without increase in Analgesics Score (AS), or a ≥50% decrease from baseline in AS without increase in the PPI score confirmed at least 3 weeks later. Increases in PPI or AS during the first 12 weeks were ignored in determining pain response.|Before randomization (baseline) then every 3 weeks up to pain progression or the cut-off date, whichever occurred first|The analysis was performed in the ITT population evaluable for pain response (i.e. stable analgesia at baseline and, baseline PPI ≥2 and/or baseline AS ≥10 points).||percentage of participants||95% Confidence Interval|Number
745878|NCT00519285|Secondary|Pain Progression-free Survival Time|"Pain progression was defined as either ≥1-point increase in Present Pain Intensity (PPI) score or ≥25% increase in Analgesics Score (AS) confirmed at least 3 weeks later, or requirement for palliative radiotherapy. PPI scale is a self-report 0-5 scale to assess pain intensity - a score 0 reflects no pain, a score 5 reflects excruciating pain. AS is a scoring method to assess analgesics consumption. Each analgesic is scored 1 or 4 depending on the analgesic type and dose. AS is the sum of the analgesic scores.
Pain progression-free survival (PFS) time was measured as the time from the date of randomization up to the date of first pain progression or death due to any cause, whichever occurred first.
The median pain-PFS and its 95% confidence interval were estimated using the Kaplan-Meier method. In the absence of event, the participant was censored at the the date of last assessment without evidence of pain progression or the study cut-off date, whichever was earlier."|From randomization up to the cut-off date (median follow-up of 35.4 months)|"The analysis was performed on the ITT population evaluable for pain progression (i.e. with no pain or with stable pain at baseline).
At the cut-off date, pain progression or death had occurred in 507 participants, 263 in the Placebo group and 244 in the Aflibercept group."||months||95% Confidence Interval|Median
745879|NCT00519285|Secondary|Prostate Specific Antigen Progression-free Survival Time|"Prostate specific antigen (PSA) progression was defined as ≥25% increase in PSA level confirmed 3 weeks later, above the nadir in participants who had achieved a PSA response, or above the baseline in participants who hadn't achieved a PSA response.
PSA progression-free survival (PFS) time was defined as the time from the date of randomization up to the date of the first documented PSA progression or death due to any cause, whichever occurred first.
The median PSA-PFS time and its 95% confidence interval were estimated using the Kaplan-Meier method. In the absence of PSA progression or death, the participant was censored at the the date of last assessment without evidence of progression or the study cut-off date, whichever was earlier."|From randomization up to the cut-off date (median follow-up of 35.4 months)|"The analysis was performed in the ITT population evaluable for PSA progression (i.e. with an evaluable baseline PSA).
At the cut-off date, PSA progression or death had occurred in 1138 participants, 571 in the Placebo group and 567 in the Aflibercept group."||months||95% Confidence Interval|Median
745880|NCT00519285|Secondary|Tumor Response Rate in Participants With Measurable Disease|Tumor response was defined as either a Complete Response (disappearance of all target lesions) or a Partial Response (≥30% decrease from baseline in target lesions) as assessed by Response Evaluation Criteria In Solid Tumors (RECIST)version 1.0.|Before randomization (baseline) then every 3 months up to tumor progression (≥25% increase) or the cut-off date, whichever occurred first|The analysis was performed on the ITT population evaluable for tumor response (i.e. received at least one dose of study drugs (aflibercept/placebo or docetaxel), had no important deviations to protocol and was evaluable for response as per RECIST version 1.0).||percentage of participants||95% Confidence Interval|Number
745914|NCT00519532|Secondary|Change From Baseline in Nocturnal Akinesia, Dystonia, and Cramps Score (NADCS) at Week 13 (End of Maintenance)|"Subjects were asked to assess nocturnal akinesia, dystonia and cramps, using an ordinal severity scale. While a score of 0= normal and 4= maximal severity, subjects could also rate their symptoms with values of 0.5, 1.5, 2.5, 3.5. The nocturnal akinesia score was used to evaluate motor performance while the dystonia and cramps scores were used to evaluate sleep.
Baseline is defined as Visit 2 of previous double- blind trial SP889."|Baseline (baseline SP889 NCT00474058) and week 13 (End of maintenance)|Full Analysis Set (FAS).||units on a scale||Standard Deviation|Mean
745881|NCT00519285|Secondary|Progression Free Survival Time|"Disease progression was defined as a composite of: Radiological tumor progression (≥20% increase in target lesions, or appearance of at least 2 new bone lesions); PSA progression (≥25% increase in PSA level confirmed 3 weeks later); Pain progression (increase in pain intensity or in analgesic consumption for cancer related pain confirmed 3 weeks later); Radiotherapy for cancer related symptoms; Occurence of Skeletal related events (SRE).
Progression Free survival (PFS) time was measured as the time from the date of randomization up to the date of occurrence of the first event defining a disease progression or death due to any cause, whichever occurred first.
The median PFS time and its 95% confidence interval were estimated using the Kaplan-Meier method. In the absence of disease progression, the participant was censored at the the date of last assessment without evidence of progression or the study cut-off date, whichever was earlier."|From randomization up to the cut-off date (median follow-up of 35.4 months)|"The analysis was performed on the ITT population.
At the cut-off date, disease progression or death had occurred in 1184 participants, 592 in each treatment group."||months||95% Confidence Interval|Median
745882|NCT00519285|Secondary|Time to Skeletal Related Events|"Skeletal Related Events (SRE) included pathological fractures and/or spinal cord compression, need for bone irradiation, including radioisotopes or bone surgery, change in antineoplastic therapy to treat bone pain.
Time to SRE was defined as the time from the date of randomization to the date of occurence of the first event defining a SRE or death due to any cause, whichever occurred first.
The median time to SRE and its 95% confidence interval were estimated using the Kaplan-Meier method. In the absence of SRE, the participant was censored at the last date he/she was known to be alive or the study cut-off date, whichever was earlier."|From randomization up to the cut-off date (median follow-up of 35.4 months)|"The analysis was performed on the ITT population.
At the cut-off date, SRE or death had occurred in 1013 participants, 516 in the Placebo group and 497 in the Aflibercept group."||months||95% Confidence Interval|Median
745883|NCT00519285|Secondary|Prostate Specific Antigen Response Rate|Prostate specific antigen (PSA) response was defined as ≥50% decrease from baseline in serum PSA levels, confirmed at least 3 weeks later. Increases of any magnitude during the first 12 weeks were ignored in determining PSA response.|Before randomization (baseline) then every 3 weeks up to PSA progression (≥25% increase) or the cut-off date, whichever occurred first|The analysis was performed on the ITT population evaluable for PSA response (i.e. with a baseline PSA ≥10 ng/mL).||percentage of participants||95% Confidence Interval|Number
745884|NCT00519285|Primary|Overall Survival Time|"Overall survival (OS) time was measured as the time from date of randomization to the date of death due to any cause.
The median OS time and its 95.6% confidence interval were estimated using the Kaplan-Meier method. In the absence of confirmation of death, the participant was censored at the last date he/she was known to be alive or the study cut-off date (when 873 deaths have occurred), whichever was earlier."|From randomization up to the cut-off date (median follow-up of 35.4 months)|"The analysis was performed on the Intent-to-treat (ITT) population (i.e all randomized participants according to the treatment assigned regardless of the drug actually received).
At the cut-off date, 873 deaths had occurred, 445 in the Placebo group and 428 in the Aflibercept group."||months||95% Confidence Interval|Median
745885|NCT00519376|Secondary|Tmax of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444|Blood samples were collected pre-dose and at 2, 5, 10, 20, and 30 minutes, 1, 2, 4, 6, 8, 10, and 24 hour post-dose. Blood samples were analyzed for GW642444 and its metabolites GI179710, GW630200 and GSK932009, using a high performance liquid chromatography/mass spectrometry/mass (HPLC/MS/MS) spectrometry. The Time to maximum plasma concentration (Tmax) was determined from the concentration time data by non-compartmental methods. Assay censoring refers to some of the values being below the limit of quantification such that this parameter could not be defined.|Day 1 of each treatment period (up to Study Day 54)|PK Population: all participants who received at least one dose and for whom a PK sample was obtained and analyzed||Hours||Full Range|Median
745886|NCT00519376|Secondary|Cmax of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444|Blood samples were collected pre-dose and at 2, 5, 10, 20, and 30 minutes, 1, 2, 4, 6, 8, 10, and 24 hour post-dose. Blood samples were analyzed for GW642444 and its metabolites GI179710, GW630200 and GSK932009, using a high performance liquid chromatography/mass spectrometry/mass (HPLC/MS/MS) spectrometry. The maximum observed plasma concentration (Cmax) was determined from the concentration time data by non-compartmental methods. Assay censoring refers to some of the values being below the limit of quantification such that this parameter could not be defined.|Day 1 of each treatment period (up to Study Day 54)|PK Population: all participants who received at least one dose and for whom a PK sample was obtained and analyzed||picograms/milliliter (pg/mL)||Geometric Coefficient of Variation|Geometric Mean
745887|NCT00519376|Secondary|AUC(0- t) and up to 1 Hour Post-dose (AUC[0-1]) of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444|Blood samples were collected pre-dose and at 2, 5, 10, 20, and 30 minutes, 1, 2, 4, 6, 8, 10, and 24 hour post-dose. Blood samples were analyzed for GW642444 and its metabolites GI179710, GW630200 and GSK932009 using a high performance liquid chromatography/mass spectrometry/mass (HPLC/MS/MS) spectrometry. AUC defined as area under the plasma concentration curve from time zero to the last quantifiable concentration (AUC(0-t)), and up to 1 hour post-dose (AUC(0-1)) were determined by non-compartmental methods. Assay censoring refers to some of the values being below the limit of quantification such that this parameter could not be defined.|Baseline and Day 1 of each treatment period (up to Study Day 54)|Pharmacokinetic (PK) Population: all participants who received at least one dose and for whom a PK sample was obtained and analyzed||picograms.Hour/milliliter (pg.hr/mL)||Geometric Coefficient of Variation|Geometric Mean
745888|NCT00519376|Secondary|Weighted Mean and Maximum/Minimum Value (0 - 4 Hours) for Glucose and Potassium|Blood samples were collected for the measurement of potassium and glucose at Screening, prior to dosing, and at 20 minutes, 45 minutes, 1,2, 3 and 4 hours post-dose on Day 1of the each treatment period. Whole blood samples (approximately 1.0 milliliter [mL]) was analysed for potassium and glucose using the i-STAT1 portable chemical analyser. The i-STAT1 system is an analyser designed for point of care testing and employs a hand-held chemistry analyzer and disposable cartridges, which in the configuration tested, are capable of measuring potassium, glucose, blood gases, electrolytes, metabolites and coagulation. Weighted mean (WM) is derived by calculating the area under curve (AUC), and then dividing by the relevant time interval. The data is presented as adjusted mean of WM and maximum (max) glucose /minimum (min) potassium.|Baseline and Day 1 of each treatment period (up to Study Day 54)|PP Population. Only those participants available at the indicated time points were assessed.||Millimoles per liter (mmol/L)||Standard Error|Mean
745889|NCT00519376|Secondary|Weighted Mean and Maximum Value (0 - 4 Hours) of Supine Systolic and Diastolic Blood Pressure|Blood pressure (BP) measurement included systolic blood pressure (SBP) and diastolic BP (DBP). Weighted mean (WM) is derived by calculating the area under curve (AUC), and then dividing by the relevant time interval. SBP and DBP were recorded at Screening, prior to dosing, and at 20 minutes, 45 minutes, 1,2, 3, 4 and 6 hours post-dose on Day 1of the each treatment period. SBP and DBP recorded at 20 minutes, 45 minutes and 1, 2, 3 and 4 hours post-dose on Day 1of the each treatment period were used for analysis. Heart rate measurement was taken in a supine position having rested in this position for at least 10 minutes before each reading. The data is presented as adjusted mean of WM and maximum SBP and DBP.|Baseline and Day 1 of each treatment period (up to Study Day 54)|PP Population. Only those participants available at the indicated time points were assessed.||Millimeters of mercury||Standard Error|Mean
745890|NCT00519376|Secondary|Weighted Mean and Maximum Value (0 - 4 Hours) Supine Heart Rate|Weighted mean (WM) is derived by calculating the area under curve (AUC), and then dividing by the relevant time interval. Heart rate was recorded at Screening, prior to dosing, and at 20 minutes, 45 minutes, 1, 2, 3, 4 and 6 hours post-dose on Day 1of each treatment period. Heart rate recorded at 20 minutes, 45 minutes and 1, 2, 3 and 4 hours post-dose on Day 1of the each treatment period were used for analysis. Heart rate measurement was taken in a supine position having rested in this position for at least 10 minutes before each reading. The data is presented as adjusted mean of WM and maximum heart rate.|Baseline and Day 1 of each treatment period (up to Study Day 54)|PP Population. Only those participants available at the indicated time points were assessed.||Beats per minute||Standard Error|Mean
745891|NCT00519376|Secondary|Weighted Mean and Maximum Value (0 - 4 Hours) QTc(B) and QTc(F)|QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the 12-lead ECG. QTcB is the QT interval corrected for heart rate using Bazett's formula; QTcF is the QT interval corrected for heart rate using Fridericia's formula. Weighted mean (WM) is derived by calculating the area under curve (AUC), and then dividing by the relevant time interval. QTcB and QTcF recorded at 20 minutes, 45 minutes, 1, 2, 3, and 4 hours post-dose on Day 1 of each treatment period were used for analysis. The data is presented as the adjusted means of WM and maximum QTc(B) and QTc(F).|Baseline and Day 1 of each treatment period (up to Study Day 54)|PP Population. Only those participants available at the indicated time points were assessed.||Milliseconds (msec)||Standard Error|Mean
745892|NCT00519376|Secondary|Mean FEV1 Over 23 and 24 Hours After Dosing|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured electronically by spirometry. The data is presented as adjusted mean of the FEV1 values over 23 and 24 hours after dosing. Changed in trough FEV1 will be analysed using a model with baseline, treatment, period, as fixed effects .|Baseline and Day 1 of each treatment period (up to Study Day 54)|PP Population. Only those participants available at the indicated time points were assessed.||Liters||Standard Error|Mean
745893|NCT00519376|Primary|Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period|ECG parameters [PR, QRS, RR, QT (uncorrected), QTcB (QT corrected by Bazett's formula) and QTcF (QT corrected by Fridericia's formula) intervals] were measured at Baseline and over the post-dose 24h period at the following scheduled time points: 20 minutes (min), 45 min, 1 h, 2 h, 3 h, 4 h, 6 h, and 24 h. Baseline was defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline and Day 1 of each treatment period (up to Study Day 54)|PP Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the PP Population.||milliseconds (msec)||Standard Deviation|Mean
745894|NCT00519376|Primary|Change From Baseline in Heart Rate Over the Post-dose 24 Hour (h) Period|Heart rate (HR) was measured at Baseline and over the post-dose 24 h period at the following scheduled time points: 20 minutes (M), 45 M, 1 h, 2 h, 3 h, 4 h, 6 h, and 24 h. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline and Day 1 of each treatment period (up to Study Day 54)|Per Protocol (PP) Population: all participants included in the All Subjects population excluding a participant deemed not to have heart rate or other ECG parameters deemed suitable for evaluation. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).||Beats per minute(bpm)||Standard Deviation|Mean
745895|NCT00519376|Primary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period|SBP and DBP were measured at Baseline and over the post-dose 24 h period at the following scheduled time points: 20 minutes (M), 45 M, 1h, 2h, 3h, 4h, 6h, and 24 h. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline and Day 1 of each treatment period (up to Study Day 54)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Millimeters of mercury (mmHg)||Standard Deviation|Mean
745896|NCT00519376|Primary|Change From Baseline in C-reactive Protein at 24 Hours Post-dose on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of c-reactive protein at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline and Day 1 of each treatment period (up to Study Day 54)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Milligrams per liter (Mg/L)||Standard Deviation|Mean
745915|NCT00519532|Primary|Change From Baseline in Parkinson Disease Sleep Scale (PDSS) at Week 13 (End of Maintenance)|"The Parkinson Disease Sleep Scale (PDSS) is a questionnaire with 15 questions to assess sleep and nocturnal disability in Parkinson´s disease. The item- scores range between 0= never and 4= very often.
Baseline is defined as Visit 2 of previous double- blind trial SP889."|Baseline (baseline SP889 NCT00474058) and week 13 (End of maintenance)|Full Analysis Set (FAS).||units on a scale||Standard Deviation|Mean
745897|NCT00519376|Primary|Change From Baseline in Total Bilirubin and Creatinine at 24 Hours Post-dose on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of total bilirubin and creatinine at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline and Day 1 of each treatment period (up to Study Day 54)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Micromoles per liter (µmol/L)||Standard Deviation|Mean
745898|NCT00519376|Primary|Change From Baseline in Cholesterol, Chloride, Potassium, Sodium, Triglycerides, and Urea at 24 Hours Post-dose on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of cholesterol, chloride, potassium, sodium, triglycerides, and urea at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline and Day 1 of each treatment period (up to Study Day 54)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Millimoles per liter (mmol/L)||Standard Deviation|Mean
745899|NCT00519376|Primary|Change From Baseline in Albumin and Total Protein at 24 Hours Post-dose on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of albumin and total protein at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline and Day 1 of each treatment period (up to Study Day 54)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Grams per liter||Standard Deviation|Mean
745900|NCT00519376|Primary|Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) Values at 24 Hours Post-dose on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of ALT, ALP, AST, and GGT at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline and Day 1 of each treatment period (up to Study Day 54)|All Subjects Population, Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||International units per liter (IU/L)||Standard Deviation|Mean
745901|NCT00519376|Primary|Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Values at 24 Hours Post-dose on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of MCH at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline and Day 1 of each treatment period (up to Study Day 54)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||10^12 picograms (pg) per cell||Standard Deviation|Mean
745902|NCT00519376|Primary|Change From Baseline in Mean Corpuscle Volume (MCV) at 24 Hours Post-dose on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of MCV at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline and Day 1 of each treatment period (up to Study Day 54)|Blood samples were collected for the measurement of MCV at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.||10^15 femtoliters (fL) per cell||Standard Deviation|Mean
745903|NCT00519376|Primary|Change From Baseline in Hematocrit at 24 Hours Post-dose on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of hematocrit at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline and Day 1 of each treatment period (up to Study Day 54)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Proportion of 1.0||Standard Deviation|Mean
745904|NCT00519376|Primary|Change From Baseline in Reticulocyte and Red Blood Cell (RBC) Count at 24 Hours Post-dose on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of reticulocyte and RBCs at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline and Day 1 of each treatment period (up to Study Day 54)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||10^12 cells per liter (TI/L)||Standard Deviation|Mean
745919|NCT00519584|Secondary|Time to a Significant Increase in Shoulder Discomfort|the length of time until the patients’ first report of surgical site pain.|during postoperative day 1 to 3|||hours||Inter-Quartile Range|Median
755843|NCT00589550|Primary|Characterize the Toxicity of Peginterferon Alfa-2b and Sorafenib in Patients With Metastatic or Unresectable Clear Cell Renal Cell Carcinoma.||up to 2 months||||||
745905|NCT00519376|Primary|Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at 24 Hours Post-dose on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of hemoglobin and MCHC at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline and Day 1 of each treatment period (up to Study Day 54)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Grams per liter (g/L)||Standard Deviation|Mean
745906|NCT00519376|Primary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell Count at 24 Hours Post-dose on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count, and white blood cell (WBC) count at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline and Day 1 of each treatment period (up to Study Day 54)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||10^9 cells per liter (GI/L)||Standard Deviation|Mean
745907|NCT00519376|Primary|Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in deciding whether reporting is appropriate in other situations. Refer to the General Adverse AE/SAE module for a complete list of AEs and SAEs.|From the first dose of the study medication until the Follow-up Visit (up to Study Day 60)|All Subjects Population: all participants who received at least one dose of study medication||Participants|||Number
745908|NCT00519428|Secondary|Quality of Life, as Measured by the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Short Form (SF)|"The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) intends to measure quality of life in 16 domains. A summary score is computed by adding the scores and dividing by 16 (or the number of answered items if some are not answered).
The minimum raw score on the Q-LES-Q-SF is 14, and the maximum score is 70. Higher score means more satisfaction."|12 weeks|All Randomized Subjects||units on the Q-LES-Q scale||Standard Deviation|Mean
745909|NCT00519428|Secondary|Functioning, as Measured by the Social Adjustment Scale (SAS) Summary Score|Social adjustment was measured using the Social Adjustment Scale (SAS). The SAS is a self-report scale that assesses depressive symptoms and functioning in nine social and work-related domains generating a total score that is indicative of a subject's overall level of social adjustment. Subjects rate their own social functioning over times on a 5-point scale on items covering work for pay, housework, extended family, parenting, marital status, social activity and leisure, family unit and student status (sub-scales). Mean values of all the sub-scales are used, with a range from 0-5. Higher score = worse outcome … worse functioning|12 weeks|All randomized patients; latest available Total SAS score used if week 12 score not available.||units on the SAS scale||Standard Deviation|Mean
745910|NCT00519428|Secondary|Severity of Depressive Symptoms as Measured by Hamilton Rating Scale for Depression (HAM-D 17)|"Last summary score rating on the 17-item Hamilton Rating Scale for Depression Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2. Range 0-58.
0-7 = Normal 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severe Depression
≥ 23 = Very Severe Depression"|12 weeks|age 18-65 with MDD, non-bipolar, non-psychotic, non-substance abusing, without intolerance to study drugs or adequate SSRI/bupropion treatment in current episode; physically healthy without contraindications to bupropion or escitalopram.||units on Hamilton Rating Scale for Depre||Standard Deviation|Mean
745911|NCT00519428|Secondary|Remission: Persistent Hamilton Rating Scale for Depression, 17 Items (HAM-D 17) <= 7, With no HAM-D 17 >7 Through Week 12|Chi square comparison of rates of persistent remission (i.e., no subsequent Hamilton Rating Scale for Depression, 17 items [HAMD-D 17] > 7 once HAMD-D 17 <= 7); Dual rate vs. Escitalopram only rate and Dual rate vs. Bupropion only rate.|12 weeks|age 18-65 with MDD, non-bipolar, non-psychotic, non-substance abusing, without intolerance to study drugs or adequate SSRI/bupropion treatment in current episode; physically healthy without contraindications to bupropion or escitalopram.||percentage of participants|||Number
745912|NCT00519428|Primary|Time to Remission, Defined by the Week of Onset of Persistent Hamilton Rating Scale for Depression (HAM-D 17) <= 7, With no Subsequent HAM-D 17 > 7|Life Table Survival Analysis run twice, once comparing Dual Therapy (i.e., Bupropion + Escitalopram) to Bupropion alone (i.e., Bupropion + Placebo) and once comparing Dual Therapy to Escitalopram alone (i.e., Escitalopram + Placebo). Because both analyses must significantly favor Dual Therapy, each individual analysis must reach a critical alpha = .0916 in order to reach an over-all alpha = .05.|12 weeks|age 18-65 with Major Depressive Disorder (MDD), non-bipolar, non-psychotic, non-substance abusing, without intolerance to study drugs or adequate selective serotonin re-uptake inhibitor (SSRI) and/or bupropion treatment in current episode; physically healthy without contraindications to bupropion or escitalopram.||weeks||Standard Deviation|Mean
745913|NCT00519532|Secondary|Change From Baseline in Number of Nocturias at Week 13 (End of Maintenance)|"The change in number of nocturias was used to evaluate improvements in sleep disorders.
Baseline is defined as Visit 2 of previous double- blind trial SP889."|Baseline (baseline SP889 NCT00474058) and week 13 (End of maintenance)|Full Analysis Set (FAS).||Nocturias||Standard Deviation|Mean
745920|NCT00519584|Primary|the Duration of Analgesia|the interval between the onset of sensory block and the initial PACU use of opioid analgesia for surgical site pain|surgical date to postoperative day 1 (pod 0 -1 day)|||hours||Inter-Quartile Range|Median
755844|NCT00589550|Primary|Maximum Tolerated Dose of PEG-interferon Alfa-2b and Sorafenib Tosylate||up to 2 months||||||
745921|NCT00519623|Primary|Pharmacodynamics of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients (GIRmax)|Study IN2007001 is designed to evaluate the PK/PD of the PassPort(R) Transdermal Insulin Delivery System in type 1 diabetes patients. The PD was determined by analysis of glucose infusion rates required to maintain the glucose clamp level of 100 mg/dL. The mean GIRmax was reported.|Glucose infusion rates were adjusted every 10 minutes as necessary|||mg/kg/min||Standard Error|Mean
745922|NCT00519623|Secondary|Skin Response to the Application of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients|Skin response was evaulated by visual skin scoring using a modified Draize scale and transepidermal water loss (TEWL) measurements. The transdermal insulin patch was well-tolerated with mild transient erythema at the application site.|Time Points: prior to microporation, after microporation, after patch removal, 24 hours after patch removal, and 7 days after patch removal||11/2010||||
745923|NCT00519623|Primary|Pharmacokinetics of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients (Cmax)|Study IN2007001 is designed to evaluate the PK/PD of the PassPort(R) Transdermal Insulin Delivery System in type 1 diabetes patients. The PK was determined by analysis of serum insulin assay values. The mean Cmax was reported.|Samples were collected at -1,-0.25, 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, 10.0, 11.0, 12.0, 12.5, 13.0, 14.0, 15.0, 16.0 hours|Number of subjects completed||uU/mL||Standard Error|Mean
745924|NCT00519636|Secondary|Subject Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) on Preference for: Gentleness of Mist|"Subjects assessed preference over gentleness of mist for the nasal sprays used during the treatment periods by answering I prefer product 1 for spray used during Treatment Period 1 or I prefer product 2 for spray used during Treatment Period 2. Subject could also choose I have no preference."|End of Crossover Period (Day 22)|Intent-to-Treat(ITT) population. These measures are from the product preference questionnaire given at the end of the study. Because questionnaires were comparative in nature, only subjects who completed both treatment periods were included in the analyses. In addition, there are small variations due to non-response for individual questions.||Participants|||Number
745925|NCT00519636|Secondary|Subject Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) on Preference for: Ease of Use|"Subjects assessed preference over ease of use for the nasal sprays used during the treatment periods by answering I prefer product 1 for spray used during Treatment Period 1 or I prefer product 2 for spray used during Treatment Period 2. Subject could also choose I have no preference."|End of Crossover Period (Day 22)|Intent-to-Treat(ITT) population. These measures are from the product preference questionnaire given at the end of the study. Because questionnaires were comparative in nature, only subjects who completed both treatment periods were included in the analyses. In addition, there are small variations due to non-response for individual questions.||Participants|||Number
745926|NCT00519636|Secondary|Subject Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) on Preference for: Leaking Out of Nose/Down Throat|"Subjects assessed preference over leaking out of nose/down throat for the nasal sprays used during the treatment periods by answering I prefer product 1 for spray used during Treatment Period 1 or I prefer product 2 for spray used during Treatment Period 2. Subject could also choose I have no preference."|End of Crossover Period (Day 22)|Intent-to-Treat(ITT) population. These measures are from the product preference questionnaire given at the end of the study. Because questionnaires were comparative in nature, only subjects who completed both treatment periods were included in the analyses. In addition, there are small variations due to non-response for individual questions.||Participants|||Number
745927|NCT00519636|Secondary|Comparision of Mean Change From Baseline Over Each Treatment Period in Nighttime Reflective Total Nasal Symptom Scores (N-rTNSS) for Active Drug Nasal Sprays Versus Placebos|Reflective Total Nasal Symptom scores (rTNSS) symptoms of rhinorrhea, nasal congestion, nasal itching, sneezing using scale of: 0=none, 1=mild, 2=moderate, 3=severe; maximum score=12.|Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21)|Intent-to-Treat(ITT) population consisted of all subjects who were randomized to study treatment, and was to form the basis of all summaries of background, demographic, safety, and efficacy data.||Scores on a scale||Standard Error|Mean
745928|NCT00519636|Secondary|Comparation of Mean Change From Baseline Over Each Treatment Period in Daytime Reflective Total Nasal Symptom Scores (D r-TNSS) for Active Drug Nasal Sprays Versus Placebos|Reflective Total Nasal Symptom scores (rTNSS) symptoms of rhinorrhea, nasal congestion, nasal itching, sneezing using scale of: 0=none, 1=mild, 2=moderate, 3=severe.|Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21)|Intent-to-Treat(ITT) population. A subject in the FP/FF group had no baseline daytime TNSS; however, does have a baseline nighttime TNSS, that value serves as the baseline 24-hour TNSS. Therefore there are 90 24-hour & nighttime TNSS observations available in the FP/FF group, but only 89 daytime TNSS observations.||Scores on a scale||Standard Error|Mean
745929|NCT00519636|Primary|Subject Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Scent/Odor|"Subjects assessed preference of scent/odor for the nasal sprays used during the treatment periods by answering I prefer product 1 for spray used during Treatment Period 1 or I prefer product 2 for spray used during Treatment Period 2. Subject could also choose I have no preference."|End of Crossover Period (Day 22)|Intent-to-Treat(ITT) population. These measures are from the product preference questionnaire given at the end of the study. Because questionnaires were comparative in nature, only subjects who completed both treatment periods were included in the analyses. In addition, there are small variations due to non-response for individual questions.||Participants|||Number
745930|NCT00519636|Primary|Comparison of Mean Change From Baseline in Daily Reflective Total Nasal Symptom Score (rTNSS) Over Each Treatment Period of Active Drug Nasal Sprays Versus Placebos|Reflective Total Nasal Symptom scores (rTNSS) symptoms of rhinorrhea, nasal congestion, nasal itching, sneezing using scale of: 0=none, 1=mild, 2=moderate, 3=severe; maximum score=12. The mean of AM and PM scores were used.|Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21)|Intent-to-Treat(ITT) population consisted of all subjects who were randomized to study treatment, and was to form the basis of all summaries of background, demographic, safety, and efficacy data.||Scores on a scale||Standard Error|Mean
746050|NCT00513292|Secondary|Asymptomatic Decreases From Baseline in Left Ventricular Ejection Fraction (LVEF) at Week 12|The summary of asymptomatic decrease in LVEF.|Baseline, at 12 week|All patients who had a MUGA or ECHO performed at week 12 are included in the summary of asymptomatic changed in LVEF at week 12.||Percentage of participants|||Number
745935|NCT00519649|Secondary|Number of Participants With Anti-HBs Antibody Concentrations Above the Cut-off Value|Anti-HBs antibody cut-off values assessed include 3.3, 10 and 100 mIU/mL|Before challenge dose of HBV vaccine|Analysis was performed on subjects from the According-to-Protocol cohort for analysis of antibody persistence for whom serological results were available at pre-HBV vaccine challenge blood sampling time point||participants|||Number
745936|NCT00519649|Primary|Number of Participants With Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-off Value|Anti-HBs antibody cut-off value assessed was 100 milli-international unit per milliliter (mIU/mL)|One month after the challenge dose of HBV vaccine|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity||participants|||Number
745937|NCT00519779|Secondary|ln(CES-D)|"log-transformed Center for Epidemiologic Studies Depression Scale (CES-D) score
The CES-D is a self-report scale designed to measure current symptoms of depression rated on a four-point likert scale.
Scores range from 0-60, with higher scores indicating a higher frequency of depressive symptoms."|every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)|intention to treat||scores on a||Standard Error|Least Squares Mean
745938|NCT00519779|Primary|Stimulated ln(TNF-alpha)|log-transformed stimulated TNF-alpha|every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)|intention to treat||ln(pg/mL)||Standard Error|Least Squares Mean
745939|NCT00519779|Primary|Stimulated ln(IL-6)|"log-transformed stimulated IL-6
Serum cytokine levels provide an assessment of systemic inflammation, the cytokine level circulating throughout the body. Higher levels are typically interrupted as worse unless an individual is acutely ill.
Stimulated cytokine production reflects the inflammatory cytokine production capacity of monocytes."|every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)|intent to treat||ln(pg/mL)||Standard Error|Least Squares Mean
745940|NCT00519779|Primary|Serum ln(TNF-a)|"log-transformed serum Tumor Necrosis Factor-alpha (TNF-alpha)
All cytokine measurements (e.g., IL-6 and TNF-a, serum and stimulated) were analyzed across time; however, no stress effects were found. Therefore, all assessments post-supplementation were averaged (time points 3-6) and analyzed to determine whether fish oil supplementation had an effect. Pooling these 4 assessments provides a better estimate of an individual’s cytokine levels because single time point measurements can be affected by changes in exercise, alcohol consumption, or sleep in the preceding 24-48 hours."|every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)|intention to treat||ln(pg/mL)||Standard Error|Least Squares Mean
745941|NCT00519779|Secondary|ln(Beck Anxiety Score)|log-transformed Beck anxiety score, min-max values - 0-4.1: higher means greater anxiety|every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)|intention to treat||units||Standard Error|Least Squares Mean
745942|NCT00519779|Primary|Serum ln(IL-6)|"log-transformed serum Interleukin-6 (IL-6)
Serum cytokine levels provide an assessment of systemic inflammation, the cytokine level circulating throughout the body. Higher levels are typically interrupted as worse unless an individual is acutely ill.
Stimulated cytokine production reflects the inflammatory cytokine production capacity of monocytes."|every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)|intention to treat||ln(pg/mL)||Standard Error|Least Squares Mean
745943|NCT00519818|Secondary|17 Hydroxyprogesterone at 08.00 Hours||Cortef after one week compared with Chronocort after one month|||nmol/l||Standard Deviation|Mean
745944|NCT00519818|Primary|Chronocort vs. Cortef Cortisol Concentrations (AUC Over 24 Hours - Time Points 0,.5,1,1.5,2,3,4,5,6,7,8,10,10.5,11, 11.5,12,13,15,17,17.5,18,18.5,19,20,22,24 Post Dose).||Cortef after one week, Chronocort after one month|Per protocol||h*nmol/l||Standard Error|Mean
745945|NCT00519831|Secondary|Progression-free Survival||after cycle 2, within 2 weeks of completing cycle 4|Data not collected due to early study termination.|||||
745946|NCT00519831|Secondary|Overall Survival||Every 30 days|Data not collected due to early study termination.|||||
745947|NCT00519831|Secondary|Duration of Response||After cycle 4|Data not collected due to early study termination.|||||
745948|NCT00519831|Primary|Overall Tumor Response Rate as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria. Sum of Partial Responses (PR) and Complete Responses (CR).|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions. Measurable lesions must be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm with conventional techniques or as > 10mm with spiral CT scan or nonmeasurable, but evaluable. Evaluable is nonmeasurable disease that includes ascites, malignant pleural/pericardial effusion, bone lesions, or marrow involvement.|Baseline, after cycle 2, within 2 weeks of completing cycle 4|||Participants|||Count of Participants
745949|NCT00519896|Secondary|Time-to-tumor Progression Measured From the Date of Enrollment to the First Date of Progression of Disease|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|At 30 days from the last dose of study treatment and then for 2 years|||months||95% Confidence Interval|Median
745950|NCT00519896|Secondary|Safety and Toxicity of Sunitinib Malate Given as a Continuous Treatment Rated for Toxicity Using the NCI Common Toxicity Criteria (CTC) Version 3.0|Only adverse events that were grade 3 and higher using NCI Common Toxicity Criteria (CTC) version 3.0 were recorded.|On day 1, monthly while on study treatment, and after completion of study treatmentthrough study completion, an average of 2 years|All patients that received at least one dose of sunitinib malate were included in the analysis.||participants|||Number
745951|NCT00519896|Primary|Overall Response Rate|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.,"|At baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months|||Participants|||Count of Participants
746063|NCT00513370|Secondary|Change in Productivity Outcomes and Costs From Baseline as Measured by the Health and Labour Questionnaire (HLQ)||16 and 24 weeks||||||
745952|NCT00520013|Secondary|Consolidation Objective Response Rate|Consolidation objective response (OR) was based on RECIST 1.0 criteria with OR defined as achieving partial response (PR) or complete response (CR). Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. For CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. If CA125 disease then OR based on Rustin criteria is a 50% decrease in serum CA125 level from two initially elevated samples confirmed by a 4th sample.|Assessments occurred every cycle (serologic) and every 3 cycles (radiologic) on consolidation treatment. Pts were allowed on consolidation therapy for up to 1 year.|The analysis dataset is comprised of all patient who started consolidation treatment.||proportion of patients||95% Confidence Interval|Number
745953|NCT00520013|Primary|Consolidation Treatment-related Toxicity Rate|Consolidation treatment-related toxicity rates based on CTCAEv3 were defined as rates of maximum grade 3 or higher toxicity events with attribution possible, probable or definite occurring during consolidation treatment and up to 30 days post-treatment.|Assessed every cycle during consolidation treatment and up to 30 days post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.|The analysis dataset is comprised of patients who were randomized to consolidation treatment.||percentage of participants||95% Confidence Interval|Number
745954|NCT00520013|Primary|Consolidation Progression-Free Survival|Consolidation PFS based on the Kaplan-Meier method was defined as the time from the first day of consolidation therapy to documented disease progression (PD) or disease-specific death. Based on RECIST 1.1, radiographic PD was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum since beginning consolidation, the appearence of one or more new lesions and/or unequivocal progression of existing non-target lesions. Based on Rustin criteria, serlogic PD was a rise in CA125 since beginning of consolidation or previously normal CA125 that rises to >/= 2xULN with either event documented on 2 occasions. Patients who were event-free were censored at the date of their last disease evaluation.|Assessments occurred every cycle (serologic) and every 3 cycles (radiologic) on consolidation treatment. Pts were allowed on consolidation therapy for up to 1 year and upon treatment discontinuation were followed for another year.|The analysis dataset is comprised of patients randomized to consolidation treatment.||months||95% Confidence Interval|Median
745955|NCT00520130|Secondary|Immune Reconstitution of Cluster of Differentiation 8 (CD8) T Cell Populations|Cluster of differentiation 3 (CD3)+cluster of differentiation 4 (CD4)+ and CD3+CD8+ T cells within the lymphocyte population were determined by flow cytometry. The absolute numbers of cells/µl were calculated from the absolute lymphocyte count.|2 weeks, 1, 3, 6, 12 and 24 months post transplant|2 of 44 patients who completed the AC arm were transplanted after our cutoff for data analysis and are not included. A total of 5 completed participants did not contribute data due to missing samples, and participants who died and were not able to supply samples for the time points indicated.||Cells/µl||Full Range|Median
745956|NCT00520130|Secondary|Immune Reconstitution of Cluster of Differentiation 4 (CD4) T Cell Populations|Cluster of Differentiation 3 (CD3)+CD4+ and CD3+Cluster of Differentiation 8 (CD8)+ T cells within the lymphocyte population were determined by flow cytometry. The absolute numbers of cells/µl were calculated from the absolute lymphocyte count.|2 weeks, and 1, 3, 6, 12 and 24 months post transplant|2 of 44 patients who completed the AC arm were transplanted after our cutoff for data analysis and are not included. A total of 5 completed participants did not contribute data due to missing samples, and participants who died and were not able to supply samples for the time points indicated.||Cells/µl||Full Range|Median
745957|NCT00520130|Secondary|Immune Reconstitution of Normal Killer (NK) Cells|Cluster of differentiation 3 (CD3) - cluster of differentiation 56 (CD56) + Natural Killer (NK) cells within the lymphocyte population were determined by flow cytometry. The absolute numbers of cells/µl were calculated from the absolute lymphocyte count.|2 weeks, and 1, 3, 6, 12, and 24 months post transplant|2 of 44 patients who completed the AC arm were transplanted after our cutoff for data analysis and are not included. A total of 5 completed participants did not contribute data due to missing samples, and participants who died and were not able to supply samples for the time points indicated.||Cells/µl||Full Range|Median
745958|NCT00520130|Secondary|Decline in Homeostatic Cytokine Interleukin 7 (IL-7) Post-Transplant|During depletion of lymphocytes during transplant conditioning, levels of homeostatic cytokines increase in the blood. These then decline with the expansion of new donor-derived cells. The rapidity of decline may predict acute graft versus host disease (AGVHD). Decline in cytokine IL-7 will be assessed by the enzyme-linked immunosorbent assay (ELISA).|Day 0, 1 week and 2 weeks|Following the focus on chronic graft-versus host disease (GVHD) as a primary outcome measure in 2011, this measure was not assessed.|||||
745959|NCT00520130|Secondary|Percentage of Participants With Late Treatment Related Mortality|Any death occurring 28 days or more after transplantation in a patient in continuous remission.|Greater than 28 days after transplantation|2 of 44 patients who completed the AC arm were transplanted after our cutoff for data analysis and are not included.||percentage of participants||95% Confidence Interval|Number
745960|NCT00520130|Secondary|Early Treatment Related Mortality|Any death occurring within 28 days after transplantation in a patient in continuous remission.|Less than or equal to 28 days after transplantation|2 of 44 patients who completed the AC arm were transplanted after our cutoff for data analysis and are not included.||participants|||Number
745961|NCT00520130|Secondary|Overall Survival|Time between the first day of transplant to the day of death.|Patients were followed for an average of up to 5 years.|2 of 44 patients who completed the AC arm were transplanted after our cutoff for data analysis and are not included.||Months||95% Confidence Interval|Median
745962|NCT00520130|Secondary|Days to Engraftment of Lymphocytes|Lymphocyte recovery: designated by the first of 3 consecutive days with absolute lymphocyte count (ALC) above 500/mm(3).|2 years|2 of 44 patients who completed the AC arm were transplanted after our cutoff for data analysis and are not included.||Days||Full Range|Median
745963|NCT00520130|Secondary|Days to Engraftment of Platelets|Platelet recovery: designated by the first of 7 days where the platelet count remains above 20,000/mm(3) without transfusion support|2 years|2 of 44 patients who completed the AC arm were transplanted after our cutoff for data analysis and are not included.||Days||Full Range|Median
746064|NCT00513370|Secondary|Change From Baseline on the EuroQol (EQ-5D) Quality of Life Questionnaire||16 and 24 weeks||||||
745964|NCT00520130|Secondary|Days to Engraftment of Neutrophils|Days to engraftment is defined as neutrophil recovery: designated by the first of 3 consecutive days with an absolute neutrophil count (ANC) above 500/mm(3).|2 years|One myeloma patient had graft failure in the AC Arm. 2 of 44 patients who completed the AC arm were transplanted after our cutoff for data analysis and are not included.||Days to neutrophil engraftment||Full Range|Median
745965|NCT00520130|Secondary|Toxicities|Here are the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|103 months and 22 days|||participants|||Number
745966|NCT00520130|Secondary|Percentage of Participants With Grade III-IV Acute Graft Versus Host Disease (GVHD)|Acute GVHD is assessed by the 1994 Consensus Conference on acute GVHD Grading criteria. See Przepiorka D, Weisdorf D, Martin P, et al. 1994 Consensus Conference on Acute GVHD Grading. Bone Marrow Transplant. 1995; 15:825-8., for grading criteria.|6 months|2 of 44 patients who completed the AC arm were transplanted after our cutoff for data analysis and are not included.||percentage of participants||95% Confidence Interval|Number
745967|NCT00520130|Primary|Changes in CD8 T Cell Receptor Vbeta Repertoire|Ribonucleic acid (RNA) was extracted from sorted CD4 and cluster of differentiation 8 (CD8) T cells and analyzed for Vbeta repertoire by nested polymerase chain reaction (PCR) analysis using Vbeta family specific primers and a labeled constant region primer (spectratyping). The receptor repertoire diversity was calculated from spectratyping data by creating a normal standard for repertoire diversity from healthy normal controls and assessing the divergence of individual patient’s T cell receptor repertoire from these standard normal donor values. In this Vbeta repertoire divergence index, lower numbers are consistent with a more normal highly diverse repertoire, and high numbers represent a highly skewed, oligoclonal repertoire. The assay is described in Memon SA et al, J Immunol Methods, 2012, 375: 84-92. The repertoire diversity of the CD4 and CD8 T cells of the donor infusion is shown for comparison.|Donor at time of collection and recipient at 1, 3, 6 and 12 months post transplant|The original intention was to perform these assays on the first 10 pts within each arm. One pt died within the first mo., others died within the 1st yr. Not all donors gave consent for research analyses to be done on their cells, hence cells from those donors were not available.||Divergence index||Full Range|Median
745968|NCT00520130|Primary|Changes in Cluster of Differentiation 4 (CD4) T Cell Receptor Vbeta Repertoire|Ribonucleic acid (RNA) was extracted from sorted CD4 and cluster of differentiation 8 (CD8) T cells and analyzed for Vbeta repertoire by nested polymerase chain reaction (PCR) analysis using Vbeta family specific primers and a labeled constant region primer (spectratyping). The receptor repertoire diversity was calculated from spectratyping data by creating a normal standard for repertoire diversity from healthy normal controls and assessing the divergence of individual patient’s T cell receptor repertoire from these standard normal donor values. In this Vbeta repertoire divergence index, lower numbers are consistent with a more normal highly diverse repertoire, and high numbers represent a highly skewed, oligoclonal repertoire. The assay is described in Memon SA et al, J Immunol Methods, 2012, 375: 84-92. The repertoire diversity of the CD4 and CD8 T cells of the donor infusion is shown for comparison.|Donor at time of collection and recipient at 1, 3, 6 and 12 months post transplant|The original intention was to perform these assays on the first 10 pts within each arm. One pt died within the first mo., others died within the 1st yr. Not all donors gave consent for research analyses to be done on their cells, hence cells from those donors were not available.||Divergence index||Full Range|Median
745969|NCT00520130|Primary|Recovery of Naïve Cluster of Differentiation 8 (CD8) T Cells|The percentage of CCR7+CD45RA+ naïve T cells within the CD4 and CD8 T cell populations was determined by flow cytometry.|Recipient recovery at 6, 12 and 24 months post transplant|A few measurements were missed, one patient was not evaluable for technical reasons and removed from the analysis, but most of the decline was due to patients that had gone off study.||% of naive (CCR7+CD45RA+) CD8 Cells||Full Range|Median
745970|NCT00520130|Primary|Recovery of Naïve Cluster of Differentiation 4 (CD4) T Cells|The percentage of C-C motif chemokine receptor 7 (CCR7)+CD45RA+ naïve T cells within the CD4 T cell populations was determined by flow cytometry.|Recipient recovery at 6, 12 and 24 months post transplant|A few measurements were missed, one patient was not evaluable for technical reasons and removed from the analysis, but most of the decline was due to patients that had gone off study.||% of naive (CCR7+CD45RA+) CD4 Cells||Full Range|Median
745971|NCT00520130|Primary|Percentage of Participants With Chronic Graft Versus Host Disease (cGVHD)|Chronic GVHD is assessed by the 2005 Chronic GVHD Consensus Project. First the individual organ scoring is done, and then based on that the Global score is determined (mild-moderate-severe). See Citation: Filipovich AH, Weisdorf D, Pavletic S, et al. National Institutes of Health consensus development project on criteria for clinical trials in chronic graft-versus-host disease: I. Diagnosis and staging working group report. Biol Blood Marrow Transplant. 2005; 11:945-56., for grading criteria.|2 years post transplant|2 of 44 patients who completed the AC arm were transplanted after our cutoff for data analysis and are not included.||percentage of participants||95% Confidence Interval|Number
745972|NCT00520130|Primary|Percentage of Participants With Grade II-IV Acute Graft Versus Host Disease (GVHD)|Acute GVHD is assessed by the 1994 Consensus Conference on Acute GVHD Grading criteria. See Przepiorka D, Weisdorf D, Martin P, et al. 1994 Consensus Conference on Acute GVHD Grading. Bone Marrow Transplant. 1995; 15:825-8., for grading criteria.|6 months|2 of 44 patients who completed the AC arm were transplanted after our cutoff for data analysis and are not included.||percentage of participants||95% Confidence Interval|Number
745973|NCT00520234|Secondary|Subjects With 1 or More Serious Drug-related Adverse Event(s)||Up to 14 days after end of therapy|Safety population, defined as all subjects who received at least one dose of study drug.||participants|||Number
745974|NCT00520234|Secondary|Subjects Who Discontinue Study Therapy Due to a Drug-related Adverse Event||Up to 14 days after end of therapy|Safety population, defined as all subjects who received at least one dose of study drug.||participants|||Number
745975|NCT00520234|Secondary|Hospital Metrics (to be Evaluated Separately for Prophylaxis and Pre-emptive Therapy Phases); Length of Stay in the Hospital, Length of Stay in the ICU, and the Costs Data for the ICU Stay and the Hospitalization, if Available.||Hospital discharge||||||
745976|NCT00520234|Secondary|Incidence of Complete and Partial Response by Clinical and Microbiological or Serological Evidence for Subjects on the Pre-emptive Therapy Phase.||Within 14 days after end of therapy||||||
745977|NCT00520234|Secondary|Time to Beta Glucan Negativity in Pre-emptive Phase.||Within 14 days after end of therapy||||||
782507|NCT00805766|Secondary|CDAI at Each Evaluation Time Point in the Increased Dose Period||every 4 weeks for up to 40 weeks||||||
745983|NCT00520234|Primary|Proven and Probable Invasive Candidiasis Based on Modified Mycoses Study Group/European Organization for Research and Treatment of Cancer (MSG/EORTC) Criteria.|Modified MSG/EORTC criteria for the diagnosis of fungal infections: Proven invasive candidiasis is defined as candidemia, Candida cultured from a sterile site, or histopathological evidence of candida infection. Probable invasive candidiasis is defined as 2 consecutive positive beta glucan levels in the presence of signs and symptoms of infection.|Within 7 days after end of therapy|Modified intent-to-treat population, defined as subjects who received at least one dose of study drug and did not have baseline invasive candidiasis.||percent of participants|||Number
745984|NCT00520286|Secondary|Reduction of Craving|Number of subjects with 21 or more consecutive days of abstinence|21 days|||Participants|||Count of Participants
745985|NCT00520286|Primary|Abstinence (Week 1 - 12)|Number of participant who abstained from methamphetamine from weeks 1 through 12|Weeks 1 - 12|||Participants|||Count of Participants
745986|NCT00520299|Secondary|Correlation Between ASS Tumor Expression and Clinical Response|Expression of ASS was analyzed by immunohistochemistry in tumor samples (archived or biopsy) at baseline and compared with overall best clinical response per RECIST. ASS tumor expression is categorized as either negative or ≤ 5% positive tumor cells.|Up to 12 months|Includes all subjects who had an ASS antigen assay performed at Baseline||participants|||Number
745987|NCT00520299|Secondary|Summary of ADI-PEG 20 Immunogenicity Over Time|Blood samples were collected at baseline, day 1 (pre-injection), day 4, day 8, and every 7 days thereafter for detection of anti-ADI antibodies.|Up to 12 months|Includes all subjects who had at least 1 post-baseline blood sample with associated pharmacokinetic analysis. Means are presented for time points at which >1 subject in any arm contributed data.||log 10 U/mL||Standard Deviation|Mean
745988|NCT00520299|Secondary|Summary of Plasma Citrulline Levels Over Time|Blood samples were collected at baseline, day 1 (pre-injection), day 4, day 8, and every 7 days thereafter for plasma citrulline levels.|Up to 9 months|Includes all subjects who had at least 1 post-baseline blood sample with associated pharmacokinetic analysis. Means are presented for time points at which >1 subject in any arm contributed data.||uM||Standard Deviation|Mean
745989|NCT00520299|Secondary|Summary of Plasma Arginine Levels Over Time|Blood samples were collected at baseline, day 1 (pre-injection), day 4, day 8, and every 7 days thereafter for plasma arginine levels.|Up to 9 months|Includes all subjects who had at least 1 post-baseline blood sample with associated pharmacokinetic analysis. Means are presented for time points at which >1 subject in any arm contributed data.||uM||Standard Deviation|Mean
745990|NCT00520299|Secondary|Summary of ADI-PEG 20 Plasma Concentrations Over Time|Blood samples were collected on day 1 (pre-injection), day 4, day 8, and every 7 days thereafter for ADI-PEG 20 plasma concentrations.|Up to 12 months|Includes all subjects who had at least 1 post-baseline blood sample with associated pharmacokinetic analysis. Means are presented for time points at which >1 subject in any arm contributed data.||nM||Standard Deviation|Mean
745991|NCT00520299|Secondary|Metabolic Tumor Response|Metabolic tumor responses were evaluated using fluorodeoxyglucose (FDG) positron emission tomography (PET) at baseline, on day 4, and at the end of every cycle.|Every 8 to 9 weeks for up to 12 months|Includes all subjects who completed the study as planned or had tumor progression during the study||participants|||Number
745992|NCT00520299|Primary|Best Overall Clinical Tumor Response|Clinical tumor responses were evaluated using disease imaging (CT preferred) performed at baseline and at the end of every cycle. Responses were categorized according to RECIST. Per RECIST for target lesions and assessed by MRI: Complete Response (CR): Disappearance of all target lesions [no evidence of disease]; Partial Response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria.|Every 8 to 9 weeks for up to 12 months|Includes all subjects who completed the study as planned or had tumor progression during the study||participants|||Number
745993|NCT00520299|Primary|Assessment of Safety and Tolerability of ADI-PEG 20|Analysis of treatment-emergent adverse events (TEAEs) reported from clinical laboratory tests, physical examinations, and vital signs.|Every 1 to 2 weeks for up to 12 months|Safety Analysis Set (all subjects who received at least 1 dose of ADI-PEG 20)||participants|||Number
745994|NCT00520351|Primary|Subjective Comfort Rating|Numeric rating scale was administered. Comfort ratings (0 - 100), 0 = Very poor comfort and 100 = Excellent comfort.|2 weeks|||Units on a scale||95% Confidence Interval|Mean
745995|NCT00520351|Primary|In-vivo Wettability|Pre-lens non-invasive tear breakup time|2 weeks|||Seconds||95% Confidence Interval|Least Squares Mean
745996|NCT00520351|Primary|Low Contrast Visual Acuity|"Low Contrast Visual Acuity with contact lenses, was measured using standardized and computer generated logMAR chart.
10 Sloan letters adopted. VA chart's target size varied from logMAR 1.0 to -0.40 in 0.1 logMAR step."|2 weeks|Analysis was per protocol||logMAR||Standard Deviation|Mean
745997|NCT00520351|Primary|High Contrast Visual Acuity|"High Contrast Visual Acuity with contact lenses, was measured using standardized and computer generated logMAR chart.
10 Sloan letters adopted. VA chart's target size varied from logMAR 1.0 to -0.40 in 0.1 logMAR step."|2 weeks|||logMAR||Standard Deviation|Mean
745998|NCT00520403|Primary|PFS - Time to Event|PFS was defined as the time in days from the date of treatment start to the date of first documented disease progression or death. Disease progression was evaluated according to RECIST using CT scans (preferred method), MRI scans, X-ray, bone scans, or clinical examination. Median PFS was estimated using the Kaplan-Meier method|Days 0, 91, 182, 273, 365, 456, and 547|ITT population.||days||Standard Error|Median
745999|NCT00520403|Secondary|Overall Survival (OS)|OS was defined as the duration from treatment start to death from any cause. Overall survival was censored at the last contact for surviving participants and missing data points.|Baseline, Day 1 of every cycle to disease progression or death (up to Week 102)|Two of 25 participants died during the course of the study, thus, median overall survival could not be analyzed.||weeks||Full Range|Median
746000|NCT00520403|Secondary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR based on assessment of confirmed complete remission (CR) or confirmed partial remission (PR) according to RECIST.|Baseline and Cycles 3, 6, 9, 13, and 17|ITT Population; missing data were imputed using the last observation carried forward (LOCF) technique. Number (n) equals (=) number of participants assessed at each specific visit.||percentage of participants|||Number
786243|NCT00839241|Primary|Frequency of Natural Killer Cells as Measured With Flow Cytometry.||Day 8 postop|||total number of cells * 10^5/mL||Standard Deviation|Mean
746001|NCT00520403|Primary|Percentage of Participants With Disease Progression or Death|Disease progression was evaluated according to the Response Evaluation Criteria In Solid Tumors (RECIST) using computed tomography (CT) scans (preferred method), magnetic resonance imaging (MRI) scans, X-ray, bone scans, or clinical examination.|Days 0, 91, 182, 273, 365, 456, and 547|Intent-to-treat (ITT) population: all participants, even those who withdrew from the study prematurely, who received at least 1 dose of study medication and for whom the primary efficacy variable was measured at least once during the time when the participant received study medication.||percentage of participants|||Number
746002|NCT00520468|Primary|Number of Participants With Response|Periodic bone marrow samples (every 3-6 months) to check cells related to disease before/during/after study. Response classifications categorized by the International Working Group Response Criteria for Myelodysplastic Syndrome (MDS) as: Complete Remission, Partial Response, Hematologic Improvement or No Response.|Response evaluation within first 3 months from start of therapy, then every 3 to 6 months|All treated patients on study included in analysis.||participants|||Number
746003|NCT00520494|Secondary|Number of Patients With Clinically Relevant Changes in Vital Signs|Vital signs included heart rate, systolic blood pressure, diastolic blood pressure, and body temperature.|At the screening visit, before and after infusions (Days 1 to 5), and at the completion visit (Week 25)|The SDS comprised all treated patients.||participants|||Number
746004|NCT00520494|Secondary|Number of Patients With Clinically Relevant Changes in Routine Laboratory Parameters|Laboratory parameters included hematology, serum chemistry, and urinalysis parameters, and were assessed at screening, Week 12 (hematology and serum chemistry) and at the completion visit (approximately Week 25).|At Weeks 12 and 25|The SDS comprised all treated patients.||participants|||Number
746005|NCT00520494|Secondary|Rate of Local Reactions by Severity and Relatedness|"The rate was the number of local reactions over the number of infusions administered.
Local reactions included:
infusion site: erythema, pain, pruritus, rash, reaction, swelling;
injection site: bruising, erythema, irritation, pruritus, swelling;
edema peripheral;
tenderness;
erythema;
pruritus; and
skin swelling.
Mild AE: Did not interfere with activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities.
Not related: Explained by factors not involving the drug, no temporal relationship; Possibly related: Occurred within a reasonable time of administration, could also be explained by concurrent disease or other drugs; Probably related: Compelling temporal relationship, could not be explained concurrent disease/other drugs; Related AE: Compelling temporal relationship, known/suspected response to the drug confirmed by improvement on stopping."|For the duration of the study, up to approximately 25 weeks|The SDS comprised all treated patients.||local reactions per infusion|Participants||Number
746006|NCT00520494|Secondary|Number of Patients With Local Reactions by Severity and Relatedness|"Local reactions included: infusion site erythema, infusion site pain, infusion site pruritus, infusion site rash, infusion site reaction, infusion site swelling, injection site bruising, injection site erythema, injection site irritation, injection site pruritus, injection site swelling, edema peripheral, tenderness, erythema, pruritus, and skin swelling.
Mild AE: Did not interfere with activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities.
Not related: Explained by factors not involving the drug, no temporal relationship; Possibly related: Occurred within a reasonable time of administration, could also be explained by concurrent disease or other drugs; Probably related: Compelling temporal relationship, could not be explained concurrent disease/other drugs; Related AE: Compelling temporal relationship, known/suspected response to the drug confirmed by improvement on stopping."|For the duration of the study, up to approximately 25 weeks|The SDS comprised all treated patients.||participants|||Number
746007|NCT00520494|Secondary|Rate of AEs by Severity and Relatedness|"The rate was the number of AEs over the number of infusions administered.
Mild AE: Did not interfere with activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities.
Not related: Explained by factors not involving the drug, no temporal relationship; Possibly related: Occurred within a reasonable time of administration, could also be explained by concurrent disease or other drugs; Probably related: Compelling temporal relationship, could not be explained concurrent disease/other drugs; Related AE: Compelling temporal relationship, known/suspected response to the drug confirmed by improvement on stopping."|For the duration of the study, up to approximately 25 weeks|The SDS comprised all treated patients.||AEs per infusion|Participants||Number
746008|NCT00520494|Secondary|Number of Patients With Adverse Events (AEs) by Severity and Relatedness|"Mild AE: Did not interfere with activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities.
Not related: Explained by factors not involving the drug, no temporal relationship; Possibly related: Occurred within a reasonable time of administration, could also be explained by concurrent disease or other drugs; Probably related: Compelling temporal relationship, could not be explained concurrent disease/other drugs; Related AE: Compelling temporal relationship, known/suspected response to the drug confirmed by improvement on stopping."|For the duration of the study, up to approximately 25 weeks|The Safety data set (SDS) comprised all treated patients.||participants|||Number
746009|NCT00520494|Secondary|Quality of Life as Measured by the Child Health Questionnaire Parent Form-50 (CHQ-PF50; Age ≤ 13 Years)|The CHQ-PF50 is a 50-item questionnaire that measures generic health concepts and is suitable for patients younger than 14 years of age. The questions are grouped into 15 domains: global health, physical functioning, role/social limitations - emotional/behavioral, role/social limitations - physical, bodily pain, behavior, global behavior, mental health, self esteem, general health perceptions, change in health, parental impact - emotional, parental impact - time, family activities, and family cohesion. Scores range from 0 to 100, with higher scores indicating a better health state.|At study completion, approximately Week 25|The analysis population comprised all patients who were treated with the study drug and completed Day 12 (the ITT data set), and for which responses to the CHQ-PF50 questionnaire were available.||units on a scale||Standard Deviation|Mean
746065|NCT00513370|Secondary|Mean Change From Baseline in Beck Depression Inventory (BDI-II) at 16 and 24 Weeks|Change in the Beck Depression Inventory from Baseline. The BDI-II contains 21 questions and is scored from 0-63; higher scores indicate more severe depression symptoms.|16 and 24 weeks|Observed Cases - subjects with nonmissing values at each time point||units on a scale||Standard Deviation|Mean
746122|NCT00513695|Secondary|Overall Survival|Kaplan-Meier estimate from the start of protocol therapy until the date of death from any cause or the last date the patient was known to be alive, assessed at two years.|Up to 2 years|||survival probability||95% Confidence Interval|Number
746010|NCT00520494|Secondary|Quality of Life as Measured by the Adapted Short Form-36 Health Survey (SF-36; Age ≥ 14 Years)|The SF-36 is a 36-item questionnaire that measures generic health concepts that are relevant across age, disease, and treatment groups. The questions are grouped into eight domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores range from 0 to 100, with higher scores indicating a better health state.|At study completion, approximately Week 25|The analysis population comprised all patients who were treated with the study drug and completed Day 12 (the ITT data set), and for which responses to the SF-36 questionnaire were available.||units on a scale||Standard Deviation|Mean
746011|NCT00520494|Secondary|Use of Antibiotics for Infection Prophylaxis and Treatment|Number of patients. Medications were classified as antibiotics according to the anatomic therapeutic chemical code.|For the duration of the study, up to approximately 25 weeks|The ITT data set comprised all patients who were treated with the study drug and completed Day 12.||participants|||Number
746012|NCT00520494|Secondary|Serum Concentrations of Specific IgGs Against H. Influenzae Type B and S. Pneumoniae at Week 25||At Week 25|The analysis population comprised all patients who were treated with the study drug and completed Day 12 (the ITT data set) and for which Week 25 specific IgG results were available.||mg/L||Standard Deviation|Mean
746013|NCT00520494|Secondary|Serum Concentrations of Specific IgGs Against H. Influenzae Type B and S. Pneumoniae On Day 12||On Day 12|The analysis population comprised all patients who were treated with the study drug and completed Day 12 (the ITT data set) and for which Day 12 specific IgG results were available.||mg/L||Standard Deviation|Mean
746014|NCT00520494|Secondary|Serum Concentrations of Specific IgGs Against Cytomegalovirus, Tetanus, and Measles at Week 25||At Week 25|The analysis population comprised all patients who were treated with the study drug and completed Day 12 (the ITT data set) and for which Week 25 specific IgG results were available.||IU/mL||Standard Deviation|Mean
746015|NCT00520494|Primary|Proportion of Patients Achieving Immunoglobulin G (IgG) Levels ≥ 5 g/L on Day 12||On Day 12|The intention-to-treat (ITT) data set comprised all patients who were treated with the study drug and completed Day 12.||proportion of patients||95% Confidence Interval|Number
746016|NCT00520494|Secondary|Serum Concentrations of Specific IgGs Against Cytomegalovirus, Tetanus, and Measles on Day 12||On Day 12|The analysis population comprised all patients who were treated with the study drug and completed Day 12 (the ITT data set) and for which Day 12 specific IgG results were available.||IU/mL||Standard Deviation|Mean
746017|NCT00520494|Secondary|Total Serum IgG Trough Levels at Week 25||At Week 25|The analysis population comprised all patients who were treated with the study drug and completed Day 12 (the ITT data set) and for which Week 25 total serum IgG results were available.||g/L||Standard Deviation|Mean
746018|NCT00520494|Secondary|Total Serum IgG Trough Levels on Day 12||On Day 12|The ITT data set comprised all patients who were treated with the study drug and completed Day 12.||g/L||Standard Deviation|Mean
746019|NCT00520494|Secondary|Overall Rate of Infections|"Annualized rate of any infection. The annualized rate was based on the total number of infections and the total number of patient study days for all patients in the specified analysis population and adjusted to 365 days.
Infections were classified as all AEs with the system organ class infections and infestations."|For the duration of the study, up to approximately 25 weeks|The ITT data set comprised all patients who were treated with the study drug and completed Day 12.||infections per patient year|Participants|95% Confidence Interval|Number
746020|NCT00520494|Secondary|IgG Increase (Change From Baseline) on Day 12||Baseline to Day 12|The analysis population comprised all patients who were treated with the study drug and completed Day 12 (the ITT data set) and for which IgG results, as required for the analysis, were available.||g/L||Standard Deviation|Mean
746021|NCT00520494|Secondary|Proportion of Patients Achieving IgG Levels ≥ 5 g/L on Day 26||On Day 26|The ITT data set comprised all patients who were treated with the study drug and completed Day 12.||proportion of participants||95% Confidence Interval|Number
746022|NCT00520494|Secondary|Proportion of Patients Achieving IgG Levels ≥ 5 g/L on Day 19||On Day 19|The ITT data set comprised all patients who were treated with the study drug and completed Day 12.||proportion of participants||95% Confidence Interval|Number
746023|NCT00520546|Secondary|Lesion Based Analysis of FEC-PET, Endorectal MRI and Combined FEC-PET/eMRI in Patients With Malignant Lesions >5mm (n=98)|PET positive lesions were measured on its own and evaluated as malignant just as hypointense lesions on MRI. In PET/MRI analysis, MRI suspect lesions without FEC uptake were considered not to be malignant. PET positive lesions in central periurethral zone with inhomogenous signal intensity and sharp edges on MRI images were also considered to be benign. PET positive lesions in the peripheral zone without a hypointense correlate on MRI were considered to be malignant. Sensitivity, specificity, accuracy, negative and positive predictive values were determined without malign lesions <=5mm.|within < 2 weeks after PET/MRI|lesion based (malignant lesions >5mm, n=98) results from FEC-PET as compared with histological results on a lesion based analysis of all patients (38)||lesions|Participants||Number
746024|NCT00520546|Secondary|Lesion Based Analysis of FEC-PET, Endorectal MRI and Combined FEC-PET/eMRI in Patients With Gleason Score >6 (3+3)|PET positive lesions in patients with Gleason >6(3+3),n=43 were measured on its own and evaluated as malignant just as hypointense lesions on MRI. In PET/MRI analysis, MRI suspect lesions without FEC uptake were considered not to be malignant. PET positive lesions in central periurethral zone with inhomogenous signal intensity and sharp edges on MRI images were also considered to be benign. PET positive lesions in the peripheral zone without a hypointense correlate on MRI were considered to be malignant. Sensitivity, specificity, accuracy, negative & positive predictive values were determined.|within < 2 weeks after PET/MRI|"lesion based (patients with Gleasons Score >6(3+3),n= 43) results from FEC-PET as compared with histological results on a lesion based analysis of all patients (38).
Gleason Grades: 1+2=well differentiated (rare), 3=moderately diff., 4=poorly diff., 5=undifferentiated
Gleason Score = histological primary grade + secondary grade (min=2,max=10)"||lesions|Participants||Number
746066|NCT00513370|Secondary|Number of Subjects Achieving a Dermatology Life Quality Index (DLQI) = 0|Number of subjects achieving a Dermatology Life Quality Index (DLQI) score of 0 (indicating total lack of impairment). The DLQI consists of 10 questions and is scored from 0-30, where 0 = total lack of impairment and 30 = my life is very much impaired.|16 and 24 weeks|Observed Cases - subjects with nonmissing values at each time point||participants|||Number
746149|NCT00520767|Secondary|Toxicity, Including Neurotoxicity||Day 1 of Each Cycle||||||
746025|NCT00520546|Secondary|Lesion Based Analysis of FEC-PET, Endorectal MRI and Combined FEC-PET/eMRI in All Patients|PET positive lesions (n=128) were measured on its own and evaluated as malignant just as hypointense lesions on MRI. In PET/MRI analysis, MRI suspect lesions without FEC uptake were considered not to be malignant. PET positive lesions in central periurethral zone with inhomogenous signal intensity and sharp edges on MRI images were also considered to be benign. PET positive lesions in the peripheral zone without a hypointense correlate on MRI were considered to be malignant. Sensitivity, specificity, accuracy, negative and positive predictive values were determined.|within < 2 weeks after PET/MRI|Comparison of lesion based (128)imaging results (FEC-PET, MRI and PET/MRI) with postoperative histological findings (all patients = 38).||lesions|Participants||Number
746026|NCT00520546|Primary|Number of Participants With Positive or Negative Results in PET, MRI or PET/MRI for Prostate Cancer Compared to Histological Findings|PET positive lesions were measured on its own and evaluated as malignant just as hypointense lesions on MRI. In PET/MRI analysis, MRI suspect lesions without FEC uptake were considered not to be malignant. PET positive lesions in central periurethral zone with inhomogenous signal intensity and sharp edges on MRI images were also considered to be benign. PET positive lesions in the peripheral zone without a hypointense correlate on MRI were considered to be malignant. At least 1 histological confirmed cancer lesion has to be detected by each of the 3 methods to be patient based true positive.|within < 2 weeks after PET/MRI|Comparison of imaging results (FEC-PET, MRI and PET/MRI) with postoperative histological findings (all patients).||participants|||Number
746027|NCT00520572|Secondary|Health Assessment Questionnaire - Disability Index (HAQ-DI) at 6 Months.|Change from baseline in HAQ-DI (a measure of patients assessment of physical function scored between zero and 3) after 6 months’ treatment, calculated as score at 6 months minus score at baseline. A change of zero indicates no effect of treatment and a negative change of 0.22 or greater indicates an improvement in symptoms. (The HAQ-DI scale runs from 0 to 3, with higher scores indicating greater disability).|Baseline to 6 months|||Composite score||Standard Deviation|Mean
746028|NCT00520572|Secondary|Disease Activity Score (Based on 28 Joint Count) (DAS28) at 6 Months.|Change from baseline in the DAS28 composite score (a measure of RA symptoms including: joint swelling and tenderness; patient’s assessment of disease activity; and ESR) after 6 months’ treatment. A change of zero indicates no effect of treatment and a negative change of 1.2 indicates a clinically important improvement in symptoms. (The DAS scale runs from 0 to 10, with the higher scores indicating worse RA symptoms).|Baseline to 6 months|||Composite score||Standard Deviation|Mean
746029|NCT00520572|Secondary|American College of Rheumatology 70 Response (ACR70) at 6 Months|The number of participants with greater to or equal to 70% improvement in the ACR composite score (a measure of RA symptoms including: joint swelling and tenderness; patient’s assessment of pain, disease activity and physical function; physician’s assessment of disease activity; and CRP) after 6 months’ treatment|6 months|||Participants|||Number
746030|NCT00520572|Secondary|American College of Rheumatology 50 Response (ACR50) at 6 Months|The number of participants with greater to or equal to 50% improvement in the ACR composite score (a measure of RA symptoms including: joint swelling and tenderness; patient’s assessment of pain, disease activity and physical function; physician’s assessment of disease activity; and CRP) after 6 months’ treatment.|6 months|||Participants|||Number
746031|NCT00520572|Primary|American College of Rheumatology 20 Response (ACR20) at 6 Months|The number of participants with greater to or equal to 20% improvement in the ACR composite score (a measure of RA symptoms including: joint swelling and tenderness; patient’s assessment of pain, disease activity and physical function; physician’s assessment of disease activity; and CRP) after 6 months’ treatment|6 months|||Participants|||Number
746032|NCT00520676|Secondary|Number of Participants With Adverse Events (AEs)|Summaries of serious AEs (SAEs) and all other non-serious AEs are located in the Reported Adverse Event Module.|Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).|Analysis was performed on safety population. This population includes all participants with non-squamous histology who received at least one dose of study drug. Participants were analysed according to treatments they actually received.||participants|||Number
746033|NCT00520676|Secondary|Survival Without Grade 4 Toxicity|Survival without Grade 4 toxicity is the time from the date of randomization to the first date of a Grade 4 TEAE or death due to any cause. Participants who are alive without experiencing Grade 4 toxicity will be censored for this analysis at the date of last contact.|Baseline to until 218 events (defined as death or Grade 4 toxicity) have been observed (up to 33.3 months).|Analysis was performed on protocol-qualified, intent-to-treat (Q-ITT) population. This population includes all data from all randomized participants, with nonsquamous histology, receiving at least 1 dose of the study drug according to the treatment the participants were assigned.||participants||95% Confidence Interval|Median
746034|NCT00520676|Secondary|Survival Without Clinically Important Grade 3 or 4 Toxicity|Survival without Grade 3 or 4 toxicity is the time from date of randomization to the first date of the following clinically important Grade 3 or 4 TEAEs graded by the Common Terminology Criteria for Adverse Events [CTCAE], version 3.0: neutropenia (lasting >5 days), febrile neutropenia, documented infections related to neutropenia, anemia, thrombocytopenia, fatigue, nausea, vomiting, diarrhea, stomatitis, and neurosensory events; or death due to any cause. Participants who were alive without experiencing Grade 3 or 4 toxicity were censored for this analysis at the date of last contact.|Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).|Analysis was performed on protocol-qualified, intent-to-treat (Q-ITT) population. This population includes all data from all randomized participants, with nonsquamous histology, receiving at least one dose of the study drug according to the treatment the participants were assigned.||months||95% Confidence Interval|Median
746035|NCT00520676|Other Pre-specified|Duration of Response|The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. CR=disappearance of all target lesions; PR=at least a 30% decrease in sum of longest diameter of target lesions.|Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).|Analysis was performed on tumour response qualified population. This population includes all participants with locally advanced or metastatic non-small cell lung cancer (NSCLC), non-squamous histology with measurable disease as defined by RECIST (Version 1.0), who received at least 1 dose of pemetrexed, docetaxel, or carboplatin.||months||95% Confidence Interval|Median
746036|NCT00520676|Secondary|Percentage of Participants With Tumor Response (Response Rate)|Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=at least a 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD)=at least a 20% increase in sum of longest diameter of target lesions; Stable Disease (SD)=small changes not meeting above criteria. Response rate (%)=Number of participants with CR+PR/Number of participants analyzed *100. Disease Control rate=Number of participants with SD+PR+CR/Number of participants analyzed *100.|Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).|Analysis was performed on tumour response-qualified population. This population includes all participants with locally advanced or metastatic non-small cell lung cancer (NSCLC), non-squamous histology with measurable disease as defined by RECIST (Version 1.0), who received at least 1 dose of pemetrexed, docetaxel, or carboplatin.||percentage of participants||95% Confidence Interval|Number
746037|NCT00520676|Secondary|Progression-free Survival (PFS)|Defined as the time from date of first dose to the first observation of disease progression (PD), or death due to any cause.|Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).|Analysis was performed on protocol-qualified, intent-to-treat (Q-ITT) population. This set includes all data from all randomized participants, with nonsquamous histology, receiving at least 1 dose of the study drug according to the treatment the participants were assigned.||months||95% Confidence Interval|Median
746038|NCT00520676|Secondary|Overall Survival (OS)|OS is the duration from enrollment to death. For participants who are alive, OS is censored at the last contact.|Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).|Analysis was performed on protocol-qualified, intent-to-treat (Q-ITT) population. This population includes all data from all randomized participants, with nonsquamous histology, receiving at least 1 dose of the study drug according to the treatment the participants were assigned.||months||95% Confidence Interval|Median
746039|NCT00520676|Primary|Survival Without Grade 3 or 4 Toxicity|"Defined as the time from date of randomization to first date of a Grade 3 or 4 treatment-emergent adverse event (TEAE; as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events [CTCAE], version 3.0) or death due to any cause. Grade 3 TEAE: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated. Grade 4 TEAE: Life-threatening consequences; urgent intervention indicated.
Participants who were alive without experiencing Grade 3 or 4 toxicity were censored at the date of last contact."|Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).|Analysis was performed on protocol-qualified, intent-to-treat (Q-ITT) population. This population includes all data from all randomized participants, with nonsquamous histology, receiving at least 1 dose of the study drug according to the treatment the participants were assigned.||months||95% Confidence Interval|Median
746040|NCT00513240|Secondary|Pharmacokinetics of High Dose Erythropoetin: 7 Erythropoetin Levels in First 24 Hours After First Dose.||24 hours after first EPO dose.||||||
746041|NCT00513240|Secondary|EEG Seizure Burden in the First 72 Postoperative Hours. (Total Minutes of EEG Seizures).||72 hours postoperatively.||||||
746042|NCT00513240|Primary|Scores on Bayley Scales of Infant Development III at Age 1 Years.|3 domains of the Bayley Scales of Infant Development III: Cognitive, Language and Motor Minimum score = 45, maximum score = 155; Population mean = 100, SD = 15; Higher scores are indicative of better outcomes Language scores are reflective of receptive communication and expressive communication subscales. Motor scores are reflective of fine motor and gross motor subscales.|1 year postoperatively|||units on a scale||Standard Deviation|Mean
746043|NCT00513240|Primary|MRI Severity of Injury Score|MRI severity of injury score change from preoperative brain MRI to 7 day postoperative MRI(decrease by 25%). Scoring of infarction, hemorrhage, white matter injury, cerebral venous sinus thrombosis, or increased lactate on MR spectroscopy.|7 days postoperatively.||||||
746044|NCT00513292|Secondary|Overall Survival (OS)|OS of Arm I and Arm II patients will be estimated using the Kaplan-Meier method. The difference will be tested using the log-rank test, stratified by tumor size (2.0 - 4.0 cm, > 4.0 cm), age (< 50, >= 50), and hormone receptor status (ER- and PgR-negative, ER- and/or PgR-positive).|From time to registration to death, assessed up to 5 years||06/2017||||
746045|NCT00513292|Secondary|Disease-free Survival (DFS)|DFS defined as inoperable progressive disease, gross residual disease following definitive surgery, local, regional or distant recurrence, contralateral breast cancer, other second primary cancers, and death prior to recurrence or second primary cancer. DFS of Arm I and Arm II patients will be estimated using the Kaplan-Meier method. The difference will be tested using the log-rank test, stratified by tumor size (2.0 - 4.0 cm, > 4.0 cm), age (< 50, >= 50), and hormone receptor status (ER- and PgR-negative, ER- and/or PgR-positive).|From time to registration to time of event, assessed up to 5 years||06/2017||||
746046|NCT00513292|Secondary|Breast Conservation Rates|Method of definitive surgery, categorized as breast conserving surgery (“lumpectomy”) or total mastectomy. Breast conservation rates will be compared using the Mantel-Haenszel test, stratified by tumor size (2.0 -4.0 cm, > 4.0 cm), age (< 50, >= 50) and hormone receptor status (ER- and PgR-negative, ER- and/or PgR positive). The Chi-squared will be conducted at the two-sided .05 level. A 95% confidence interval will be computed for the difference in breast conservation rates.|From time surgery to up to 5 years||06/2017||||
746047|NCT00513292|Secondary|Change in LVEFs (From Regularly Scheduled Multi Gated Acquisition Scan (MUGA)/Echo Scans) From Baseline and at 24 Week|Difference from pretreatment LVEF (%) at 24 weeks [median change from baseline Inter Quartile Range (IQR)].|Baseline, at 24 week|All patients who had a MUGA or ECHO performed at week 24 are included in the summary of asymptomatic changed in LVEF at week 24.||percent||Inter-Quartile Range|Median
746048|NCT00513292|Secondary|LVEFs From Regularly Scheduled Multi Gated Acquisition Scan (MUGA)/Echo Scans as Reported at 12 Week|All patients who had a MUGA or ECHO performed at week 12 are included in the summary of asymptomatic changed in LVEF at week 12. Difference from pretreatment LVEF (%) at 12 weeks [median change from baseline Inter Quartile Range (IQR)].|At 12 week|||percent||Inter-Quartile Range|Median
746049|NCT00513292|Secondary|Asymptomatic Decreases From Baseline in LVEF at Week 24|The summary of asymptomatic changed in LVEF.|Baseline, at 24 week|All patients who had a MUGA or ECHO performed at week 24 are included in the summary of asymptomatic changed in LVEF at week 24.||Percentage of Participants|||Number
746150|NCT00520767|Secondary|Organ Response Rate (OrR)||Beginning of cycles 4, 8, 12, 16 and 20, at follow up and end of study.||||||
746051|NCT00513292|Secondary|Combined pCR Rate in the Breast and Axillary Lymph Nodes Defined as no Evidence of Invasive Tumor Remaining in Either the Breast or Axillary Nodes at Surgery Following Completion of Chemotherapy|pCR Rate in the Breast and Axillary Lymph Nodes Defined as no Evidence of Invasive Tumor Remaining in Either the Breast or Axillary Nodes at Surgery Following Completion of Chemotherapy (among those with Metastasis to movable ipsilateral axillary lymph node(s) (cN1-3) disease).|Up to 5 years|All patients who had clinical N1-3 disease prior to the start of treatment are included in the analysis of the pCR rate in the breast and axillary lymph nodes.||Percentage (95% confidence Interval)||95% Confidence Interval|Number
746052|NCT00513292|Primary|pCR Within the Breast, Defined as no Evidence of Invasive Tumor Remaining in the Breast at Surgery Following Completion of Chemotherapy|Pathological complete response (pCR) rates will be based on institutional pathology reports. In the final analysis for publication, rates will be based on blinded central review of these institutional pathology reports. The Chi-squared test will be conducted at the two-sided 0.05 level. A 95% confidence interval will be computed for the difference in pCR rates.|Up to 5 years|All patients who started study treatment are included in the analysis of the primary endpoint.||percentage of participants||95% Confidence Interval|Number
746053|NCT00513305|Secondary|Proportion of Participants Surviving at 6 Months and 12 Months Using the Kaplan Meier Estimate|The duration of overall survival was defined for all patients and was measured from the date of randomization until death from any cause. For a patient who was not known to have died by the end of the follow-up period, observation of overall survival was censored on the date the patient was last known to be alive. The estimate of likelihood of survival at 6 and 12 months after Baseline using the Kaplan Meier Estimate is presented here.|Baseline through 12 months|||Proportion of Participants||95% Confidence Interval|Number
746054|NCT00513305|Secondary|Number of Participants Who Experienced Induction (Thirty-Day) Mortality|The number of subjects who died from any cause within the first 30 days after the start of study drug treatment is presented here.|Up to 30 days following start of study drug treatment|||Participants|||Number
746055|NCT00513305|Secondary|Number of Participants Who Experienced Early Death|Early death is defined as death from any cause within the first 14 days after start of study drug treatment. The number of patients in each study group who experienced early death is presented here.|14 days from start of study drug treatment|||Participants|||Number
746056|NCT00513305|Secondary|Proportion of Participants With Relapse-Free Survival (RFS)Using the Kaplan-Meier Estimate|RFS is defined for patients who achieved a complete remission (CR), complete remission with incomplete platelet recovery (CRp), or partial remission(PR), and was measured from the date of attaining CR, CRp, or PR until the date of AML relapse or death from any cause, whichever occurred first. For a patient not known to have relapsed or died by the end of the study followup, observation of relapse free survival was censored on the date of the last followup examination. The Kaplan Meier Estimate of relapse-free survival at Month 3 and Month 6 is presented here.|From Baseline (randomization) through 24 months following Baseline|Population analyzed are the subjects who who achieved a complete remission (CR), complete remission with incomplete platelet recovery (CRp), or partial remission(PR)during the course of the study||Proportion of participants||95% Confidence Interval|Number
746057|NCT00513305|Secondary|Number of Participants Who Died or Were Censored by 24 Months|This measure (time to death or censor) was defined for all enrolled subjects from the date of randomization until death from any cause. If a subject was not known to have died by the end of the followup period, observation of overall survival was censored on the date the patient was last known to be alive. The number of participants who died or were censored is presented here. (Note: all subjects participating in this study had either died or were censored by 24 months.)|From Baseline through 24 months following Baseline|||Participants|||Number
746058|NCT00513305|Primary|Percentage of Participants in Complete Remission (CR)|The primary efficacy variable was the percentage of subjects in each treatment group who achieved complete remission after treatment with study drug. Complete remission was defined as: 1) Less than 5% blasts in normocellular bone marrow sample. 2) No blasts in bone marrow sample containing Auer rods. 3)Clearance of previous extramedullary disease. 4)Normal values for absolute neutrophil count (at least 1000/microliter), platelet count (at least 100,000/microliter), without platelet transfusions, and in absence of peripheral myeloblasts.|From baseline through Day 70. Assessments were performed on Day 21 in cycle 1, no later than Day 56 of cycle 1 or 2 (if applicable), and no later than Day 70 of cycle 1 or 2 (if applicable) or at any other time at the discretion of the investigator|Intention to treat (ITT) Analysis Set||Percentage of participants in CR|||Number
746059|NCT00513344|Secondary|Change in Arterial Stiffness From Baseline (20 Min Before Product Intake) to Two Hours Following Product Intake|"Value of arterial stiffness at 2 hours minus value at baseline. Arterial stiffness is also automatically calculated by peripheral arterial tonometry which consists in measuring the peripheral vessel endothelial response to an ischemia provoked by a 5-min occlusion of the humeral artery using an armcuff.
An increase in arterial stiffness means an increase in the resistance of the vessel wall which reflects an impaired endothelial response to ischemia."|baseline and 2 hours|||percentage of baseline||Standard Deviation|Mean
746060|NCT00513344|Primary|Change in Reactive Hyperemia Index (RHI) From Baseline (20 Min Before Product Intake) to 2 Hours Following Product Intake|Value of RHI at 2 hours minus value at baseline. RHI reflects the endothelial function of a vessel at the distal phalanx of a finger, i.e. the capacity of the vessel to dilate after an ischemia. RHI is the increase of blood flow following the occlusion of the brachial artery during 5 minutes by the inflation of an armcuff. RHI was measured by peripheral arterial tonometry using a fingerprobe connected to an EndoPat analyser.|Baseline and 2 hours|"Taking into account the fact that there is no background data and that we need to have accurate evaluation of central tendency and dispersion, a minimum of five complete subjects are needed.
Data from all randomized subjects were considered in the intention to treat model (for the primary outcome)."||percentage of the pulse wave amplitude||Standard Error|Mean
746061|NCT00513357|Primary|Change in Appetite as Measured by ESAS|Difference in ESAS (Edmonton Symptom Assessment Scale) assessment scores of appetite (symptom) from baseline evaluation [± 3 days] to 4 week evaluation [± 3 days], where the severity at the time of assessment is rated from 0 to 10 on a numerical scale; with 0 meaning that the symptom is absent and 10 that it is the worst possible severity.|Baseline and at 4 weeks|||units on a scale||Standard Deviation|Mean
746062|NCT00513370|Secondary|Change in Resource Utilization Outcomes and Costs From Baseline as Measured by the Health Care Resource (HCR) Questionnaire||16 and 24 weeks||||||
746067|NCT00513370|Secondary|Mean Change From Baseline in the Dermatology Life Quality Index (DLQI) at 16 and 24 Weeks|Mean change in the Dermatology Life Quality Index (DLQI) from Baseline. The questionnaire contains 10 questions and is scored from 0-30, where 0 = total lack of impairment and 30 = my life is very much impaired; the minimum clinically important difference is 2.3 to 5.7 point change.|16 and 24 weeks|Observed Cases - subjects with nonmissing values at each time point||units on a scale||Standard Deviation|Mean
746068|NCT00513370|Secondary|Mean Change From Baseline in Patient's Global Assessment of Joint Pain at 16 and 24 Weeks|Mean change in the Patient's Global Assessment of Joint Pain from Baseline, as assessed on a 100-mm visual analog scale where 0 mm = no pain and 100 mm = pain as bad as it could be.|16 and 24 weeks|Observed Cases - subjects with nonmissing values at each time point||units on a scale||Standard Deviation|Mean
746069|NCT00513370|Secondary|Mean Change From Baseline in Swollen Joint Count at 16 and 24 Weeks|Mean change in the number of swollen joints from Baseline. 76 joints were evaluated for swelling, corresponding to all joints evaluated for tenderness except for the hip joints.|16 and 24 weeks|Observed Cases - subjects with nonmissing values at each time point||number of joints||Standard Deviation|Mean
746070|NCT00513370|Secondary|Mean Change From Baseline in Tender Joint Count at 16 and 24 Weeks|Mean change in the number of tender joints from Baseline. 78 joints were evaluated for tenderness, including all 76 joints evaluated for swelling plus the hip joints.|16 and 24 weeks|Observed Cases - subjects with nonmissing values at each time point||number of joints||Standard Deviation|Mean
746071|NCT00513370|Secondary|Number of Subjects With Psoriasis Area and Severity Index (PASI) 50/75/90/100 Response|PASI 50/75/90/100 is a >=50% / >=75% / >=90% / 100% improvement on the Psoriasis Area and Severity Index (PASI). The PASI scale runs from 0-72, where 0 = no psoriasis and 72 = complete erythroderma of the severest possible degree.|16 and 24 weeks|Observed Cases - subjects with nonmissing values at each time point||participants|||Number
746072|NCT00513370|Secondary|Mean Change From Baseline in Physician Global Assessment of Arthritic Disease Activity at 16 and 24 Weeks|Mean Change from Baseline in Physician Global Assessment of Arthritic Disease Activity as measured on a 100-mm visual analog scale where 0 mm = no arthritis activity and 100 mm = extremely active arthritis.|16 and 24 weeks|Observed Cases - subjects with nonmissing values at each time point||units on a scale||Standard Deviation|Mean
746073|NCT00513370|Secondary|"Number of Subjects Achieving a Clinical Response Defined as a Physician's Global Assessment for Psoriasis (PGA) of Clear or “Clear or Minimal”"|"Number of subjects achieving a response of Clear or Clear or Minimal on the Physician's Global Assessment for Psoriasis. This is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the subject. The degree of overall severity is rated as follows: 0-Clear, 1-Minimal, 2-Mild, 3-Moderate, 4-severe, 5-very severe."|16 and 24 weeks|Observed Cases - subjects with nonmissing values at each time point||participants|||Number
746074|NCT00513370|Secondary|Number of Subjects With Improvement in Physician's Global Assessment for Psoriasis (PGA)|Number of subjects with improvement on the Physician's Global Assessment for Psoriasis (PGA). The PGA is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the subject, where 0 = clear and 6 = very severe. Improvement is defined as a reduction in PGA score.|16 and 24 weeks|Observed Cases - subjects with nonmissing values at each time point||participants|||Number
746075|NCT00513370|Secondary|Mean Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at 16 and 24 Weeks|Mean percent change in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI score ranges from 0-72, where 0 = no psoriasis and 72 = complete erythroderma of the severest possible degree.|16 and 24 weeks|Observed Cases - subjects with nonmissing values at each time point||percent change||Standard Deviation|Mean
746076|NCT00513370|Secondary|Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at 16 and 24 Weeks|Mean change in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI score ranges from 0-72, where 0 = no psoriasis and 72 = complete erythroderma of the severest possible degree|16 and 24 weeks|Observed Cases - subjects with nonmissing values at each time point||unit on a scale||Standard Deviation|Mean
746077|NCT00513370|Primary|Number of Subjects With Psoriasis Area and Severity Index (PASI) 75 Response at 16 Weeks|PASI 75 is a 75% or greater improvement on the Psoriasis Area and Severity Index (PASI). The PASI scale runs from 0-72, where 0 = no psoriasis and 72 = complete erythroderma of the severest possible degree|16 weeks|Observed Cases - subjects with nonmissing values at each time point||participants|||Number
746078|NCT00513409|Secondary|Number of Subjects With Anti-hepatitis A Antibody Concentrations Above the Cut-off Value|Anti-hepatitis A antibodies cut-off value assessed was ≥ 15 mIU/mL.|Before (pre) and one month after (post) the administration of Dose 2|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results.||subjects|||Number
746079|NCT00513409|Secondary|Anti-hepatitis A Virus Antibodies Concentration|Concentration of anti-hepatitis A antibodies given as geometric mean concentration (GMC) in milli-international units per milliliter (mIU/mL).|Before (pre) and one month after (post) the administration of Dose 2|Analysis was performed on the ATP cohort for analysis of immunogenicity,on subjects with available results||mIU/mL||95% Confidence Interval|Geometric Mean
746080|NCT00513409|Secondary|Number of Subjects With Anti-protein D Antibody Concentrations Above the Cut-off Value|Anti-protein D antibody cut-off value assessed was ≥ 100 Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per milliliter (EL.U/mL).|Before (pre) and one month after (post) the administration of Dose 2|Analysis was performed on the ATP cohort for analysis of immunogenicity,on subjects with available results||subjects|||Number
746081|NCT00513409|Secondary|Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value|"Cut-off value for opsonophagocytic activity against pneumococcal antibody assessed was ≥ 8
The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F."|Before (pre) and one month after (post) the administration of Dose 2|Analysis was performed on the ATP cohort for analysis of immunogenicity,on subjects with available results||subjects|||Number
746082|NCT00513409|Secondary|Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value|"Anti-pneumococcal antibody cut-off value assessed was 0.20 microgram per milliliter (μg/mL).
The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F."|Before (pre) and one month after (post) the administration of Dose 2|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available results||subjects|||Number
746083|NCT00513409|Secondary|Number of Subjects Reporting Serious Adverse Events Throughout the Entire Study Period|"An SAE is any untoward medical occurrence that:
results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above."|Throughout the entire study period (from the beginning of the booster phase up to the end of the 6-month extended safety follow-up)|||subjects|||Number
746084|NCT00513409|Secondary|Number of Subjects Reporting Serious Adverse Events During the Active Phase of the Study|"A serious adverse event (SAE) is any untoward medical occurrence that:
results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above."|Throughout the active phase of the study ( from the beginning of the booster phase up to 1 month after the second booster dose)|||subjects|||Number
746085|NCT00513409|Secondary|Number of Subjects Reporting Unsolicited Adverse Events|An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Within 31 days after the administration of any study vaccine dose|||subjects|||Number
746086|NCT00513409|Secondary|Number of Subjects Reporting Solicited General Symptoms|"Solicited general symptoms assessed include drowsiness, fever, irritability and loss of appetite.
Fever was defined as rectal temperature ≥ 38 degrees Celsius."|Within 4 days after the administration of any study vaccine dose|Analysis was performed on all subjects included in the Total Vaccinated Cohort, who returned the symptom sheet.||subjects|||Number
746087|NCT00513409|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling.|Within 4 days after the administration of any study vaccine dose|Analysis was performed on all subjects included in the Total Vaccinated Cohort, who returned the symptom sheet.||subjects|||Number
746088|NCT00513409|Primary|Number of Subjects Reporting Grade 3 Symptoms (Solicited and Unsolicited)|Grade 3 symptoms are symptoms which prevent normal, everyday activities (e.g. in a young child such symptom would prevent attendance at school/ kindergarten/ a day-care center and would cause the parents/guardians to seek medical advice).|Within 4 days after the administration of any study vaccine dose|Analysis was performed on all subjects included in the Total Vaccinated Cohort, who returned the symptom sheet.||subjects|||Number
746089|NCT00513435|Secondary|Overall Survival|The Kaplan-Meier method will be used to estimate overall survival.|Up to 12 weeks|||Days||Full Range|Median
746090|NCT00513435|Primary|Overall Response Rate|Response was determined as inicated in the protocol.|From the start of treatment for up to 12 weeks|||participants|||Number
746091|NCT00513474|Secondary|Graft-versus-host and Host-versus-graft Immune Responses|Laboratory tests such as limited dilution assay (LDA) were to be performed to assess graft-versus-host and host-versus-graft immune responses.|Days -2, 0, and Days 14, 21 and 35 days post-transplant|Due to laboratory and budgetary issues the planned laboratory testing and assays were not performed and no data were collected.|||||
746092|NCT00513474|Secondary|Number of Participant With Adverse Events (AE)|An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment.|Up to 71 months|Safety population included all participants who received at least one dose of protocol specified treatment and were in remission at the time of transplant.||Participants|||Count of Participants
746093|NCT00513474|Secondary|Uric Acid Levels|Blood was collected and analyzed at a laboratory for serum uric acid levels reported in milligrams(mg)/deciliter(dL). Data is presented for those participants who experienced Grade II to IV aGVHD and those participants who did not experience Grade II to IV aGVHD at pre-transplant and post-transplant.|Pre-transplant Day -7 to Day -1 and Post-transplant Day 0 to Day 6|Intent-to-treat population with data available for analyses.||mg/dL||Standard Deviation|Mean
746094|NCT00513474|Primary|Percentage of Participants With Grades II to IV Acute Graft-Versus-Host Disease (aGVHD)|"aGVHD severity was determined using International Bone Marrow Transplant Registry (IBMTR) scale stage and grade of the skin, liver and gut. Stage 1: Skin=maculopapular rash <25% of body surface; Liver=Bilirubin 2-3 mg/dL and Gut=500-999 mL diarrhea/day or peristent nausea with histologic evidence of GvHD. Stage 2: Skin=maculopapular rash 25-50% of body surface; Liver=Bilirubin 3.1-6 mg/dL and Gut=1000-1499 mL diarrhea/day. Stage 3: Skin=maculopapular rash >50% of body surface; Liver=Bilirubin 6.1-15 mg/dL and Gut=≥1500 mL diarrhea/day. Stage 4: Skin=generalized erythroderma with bulla formation; Liver=Bilirubin >15 mg/dL and Gut=severe abdominal pain.
Grade 1: Stage 1-2 rash; no liver or gut involvement. Grade II: Stage 3 rash, or stage 1 liver involvement, or stage 1 gut involvement. Grade III: None to stage 3 skin rash with stage 2-3 liver, or stage 2-4 gut involvement. Grade IV: Stage 4 skin rash, or stage 4 liver involvement."|Up to 71 months|Intent-to-treat participants included in the analyses.||percentage of participants|||Number
746095|NCT00513500|Secondary|Number of Children Who do Not Respond to Treatment for Pneumonia||one year|Based on number classified as having pneumonia. Analysis was per intention to treat||participants|||Number
746096|NCT00513500|Primary|Number of Children With Fever Who Received Coartem (Artemether-lumefantrine)||one year|The participants analyzed was based on children reported with fever. Analysis was per intention to treat.||participants|||Number
746097|NCT00513500|Primary|Number of Children Who Received Early and Appropriate Treatment for Pneumonia.|Early and appropriate is defined as receiving 13-15 doses of amoxicillin over 5 days and receiving the first dose within 24-48 hours of onset of first symptom|one year|The number of participants determined for this analysis was based on those classified as pneumonia. The analysis was based on an intent-to-treat basis.||partcipants|||Number
746098|NCT00513526|Secondary|Evaluate Oral Levels of Serum IgA Before and After the Vaccination Series||Weeks 0, 28 and 76|Samples for this outcome measure were not analyzed due to loss of funding for the central lab.|||||
746099|NCT00513526|Secondary|HPV Antibody Titers to Type 18 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status||weeks 0, 28, and 76|Intent to treat population, includes all participants who received at least one dose of vaccine||Milli-Merck units/mL||95% Confidence Interval|Geometric Mean
746100|NCT00513526|Secondary|HPV Antibody Titers to Type 16 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status||weeks 0, 28, and 76|Intent to treat population, includes all participants who received at least one dose of vaccine||Milli-Merck units/mL||95% Confidence Interval|Geometric Mean
746102|NCT00513526|Primary|Detectable Human Papillomavirus (HPV) Antibody to Type 18 a Month After the Completion of HPV Vaccination Series (Week 28) Among Patients Seronegative for Type 18 at Baseline||Week 28|Per protocol population for a given HPV type requires patients to be seronegative for that type at entry and to have no HPV DNA detected by PCR for that type at entry and screening. Also, patients must have received 3 doses of vaccine.||proportion of participants||95% Confidence Interval|Number
746103|NCT00513526|Primary|Detectable Human Papillomavirus (HPV) Antibody to Type 16 a Month After the Completion of HPV Vaccination Series (Week 28) Among Patients Seronegative for Type 16 at Baseline||Week 28|Per protocol population for a given HPV type requires patients to be seronegative for that type at entry and to have no HPV DNA detected by PCR for that type at entry and screening. Also, patients must have received 3 doses of vaccine.||proportion of participants||95% Confidence Interval|Number
746104|NCT00513526|Primary|Detectable Human Papillomavirus (HPV) Antibody to Type 11 a Month After the Completion of HPV Vaccination Series (Week 28) Among Patients Seronegative for Type 11 at Baseline||Week 28|Per protocol population for a given HPV type requires patients to be seronegative for that type at entry and to have no HPV DNA detected by PCR for that type at entry and screening. Also, patients must have received 3 doses of vaccine.||proportion of participants||95% Confidence Interval|Number
746105|NCT00513526|Secondary|HPV Antibody Titers to Type 6 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status||weeks 0, 28, and 76|Intent to treat population, includes all participants who received at least one dose of vaccine||Milli-Merck units/mL||95% Confidence Interval|Geometric Mean
746106|NCT00513526|Secondary|Longitudinal Changes in Plasma HIV-1 RNA From Baseline|Plasma HIV-1 RNA at week 0 was subtracted from plasma HIV-1 RNA at each of weeks 4, 12, and 28.|Week 0, 4, 12, 28|Intention to treat population, includes all participants who received at least one dose of vaccine and had assessments at week 0 and the specified week.||copies/ml||Inter-Quartile Range|Median
746107|NCT00513526|Secondary|Longitudinal Changes in CD4+ Cell Count From Baseline|CD4+ cell count at week 0 was subtracted from CD4+ cell counts at each of weeks 4, 12, and 28.|Week 0, 4, 12, 28|Intention to treat population, includes all participants who received at least one dose of vaccine and had assessments at week 0 and the specified week.||cells/uL||Inter-Quartile Range|Median
746108|NCT00513526|Primary|Detectable Human Papillomavirus (HPV) Antibody to Type 6 a Month After the Completion of HPV Vaccination Series (Week 28) Among Patients Seronegative for Type 6 at Baseline||Week 28|Per protocol population for a given HPV type requires patients to be seronegative for that type at entry and to have no HPV DNA detected by PCR for that type at entry and screening. Also, patients must have received 3 doses of vaccine.||proportion of participants||95% Confidence Interval|Number
746109|NCT00513526|Primary|Occurrence of ≥ Grade 3 Adverse Events Probably or Definitely Related to the Vaccine||All study visits|Intention to treat (i.e., received at least one dose of the vaccine)||participants|||Number
746110|NCT00513604|Primary|Toxicity|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|5 years|||Participants|||Number
746111|NCT00513604|Primary|Clinical Response|Clinical response is defined as complete response (CR)- a disappearance of all target lesions, partial response (PR) - at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progression (PD)- at least a 20% increase in the sum of the LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) - neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.|every 1-3 months until disease progression. Total length of time -8/7/2007 to 9/27/2012|||Participants|||Number
746112|NCT00513617|Secondary|Fetal Hemoglobin|Fetal hemoglobin (HbF) as measured by the Advia machine|12 weeks after randomization||||||
746113|NCT00513617|Secondary|Endothelin-1|Endothelin-1 is a potent vasoconstrictor and pro-inflammatory agent which is elevated in SCD patients|12 weeks after randomization||||||
746114|NCT00513617|Secondary|8-iso-PGF2a|8-iso-PGF2a is a measure of lipid peroxidation and oxidative damage in vivo measured by enzyme immunoassay kit from Cayman chemical|12 weeks after randomization||||||
746115|NCT00513617|Primary|Mean Corpuscular Hemoglobin Concentration|Mean corpuscular hemoglobin concentration as measured by an Advia machine|12 weeks after randomization|||g/dL||Standard Deviation|Mean
746116|NCT00513617|Primary|Nitric Oxide|Nitric oxide from plasma amino acids|12 weeks after randomization|All subjects that were randomized and dosed - ITT No imputation used.||uM||Standard Deviation|Mean
746117|NCT00513617|Secondary|Soluble Vascular Cell Adhesion Molecule|Soluble vascular cell adhesion molecule (sVCAM) a vascular adhesion molecule|12 weeks after randomization||||||
746118|NCT00513617|Primary|Gardos Channel Activity|Gardos channel activity: a calcium (Ca2+)–activated K+ channel|12 weeks after randomization|All subjects that were randomized and dosed - Intent to Treat (ITT) No imputation used.||mmol/10^13 cells x min||Standard Deviation|Mean
746119|NCT00513682|Secondary|Percent Coefficient of Nitrogen Absorption (CNA)|Percent CNA was calculated as [(nitrogen intake-nitrogen excretion)/nitrogen intake]*100, determined by the stools collected during the 72- hour period in either washout phase or treatment phase. Nitrogen intake was calculated as protein intake/6.25. Nitrogen excretion was measured as total fecal nitrogen. Mean percent CNA was calculated for Day 3 to Day 5 or Day 6 of the respective phase.|Day 3 to Day 5 or Day 6 during washout phase and treatment phase|Intent-to-treat (ITT) population included all the participants who took at least 1 dose of Ultrase® MT20 and had completed at least 1 phase (washout or treatment phase) evaluating primary and secondary efficacy parameters.||Percent CNA||Standard Deviation|Mean
746120|NCT00513682|Primary|Percent Coefficient of Fat Absorption (CFA)|Percent CFA was calculated as ([fat intake - fat excretion]/fat intake)*100, determined by the stools collected during the 72-hour period in either washout phase or treatment phase. Mean percent CFA was calculated for Day 3 to Day 5 or Day 6 of the respective phase.|Day 3 to Day 5 or Day 6 during washout phase and treatment phase|Intent-to-treat (ITT) population included all the participants who took at least 1 dose of Ultrase® MT20 and had completed at least 1 phase (washout or treatment phase) evaluating primary and secondary efficacy parameters.||Percent CFA||Standard Deviation|Mean
746121|NCT00513695|Secondary|Number and Percent of Subjects Reporting Adverse Events|See Adverse Events section for more details.|28 days after the last dose of study drug|||Participants|||Count of Participants
746123|NCT00513695|Secondary|Time to Disease Progression|Median time to disease progression, at two years, as defined by clear increase in disease sites present at registration or development of new disease sites.|Up to 2 years|||days||95% Confidence Interval|Median
746124|NCT00513695|Secondary|Relapse Rate|Cumulative incidence rate of relapse, assessed at two years. Death is considered a competing risk.|Up to two years|||probability of relapse||95% Confidence Interval|Number
746125|NCT00513695|Secondary|Clinical Complete Response and Correlation With Plasma VEGF, Soluble VCAM (sVCAM), and Circulating Endothelial Cells (CECs) Levels||At baseline, after week 12 of therapy, and prior to surgery|Data not collected|||||
746126|NCT00513695|Primary|Microscopic Pathologic CR (pCR) Rate|Defined as no evidence of microscopic invasive tumor present at primary tumor site in the surgical specimen and calculated with exact 90% binomial confidence interval.|At the time of surgery|||percent of evaluable participants||95% Confidence Interval|Number
746127|NCT00513708|Secondary|Completed Inpatient Treatment|"Completion of inpatient treatment was defined as being admitted to and successfully discharged from an inpatient alcohol treatment program (e.g., a 28-day program). Participants who left the inpatient program against medical advice or who received an administrative discharge were not considered to have successfully completed the inpatient program."|90 days|"There were 50 participants in each arm; the number of participants analyzed represents the number of those 50 in each arm who were admitted to an inpatient treatment program (e.g., a 28-day program)."||Participants|||Number
746128|NCT00513708|Secondary|Relapse to Drinking|"Relapse to drinking was defined as the consumption of one or more standard drinks (approximately 12 grams of ethanol)during the first 30 days following discharge from the inpatient detoxification unit. The date of discharge was considered to be Day 1."|30 days|"There were 50 participants in each arm. Per protocol, the number of participants analyzed represents the number that had outcome data (i.e, relapse or no relapse) available at the 30-day follow-up."||participants|||Number
746129|NCT00513708|Primary|"Linkage to Alcohol Behavioral Therapy Counseling (i.e., Aftercare)"|"Linkage to alcohol behavioral therapy counseling (i.e., aftercare) was defined as: arriving for the first outpatient chemical dependency counseling visit, being admitted to an inpatient or residential chemical dependency treatment facility, or attending at least one meeting of a help-help program such as Alcoholics Anonymous."|1 month|"There were 50 participants in each arm. Per protocol, the number of participants analyzed represents the number that had outcome data (i.e, linked to aftercare or not linked to aftercare) available at the 30-day follow-up."||participants|||Number
746130|NCT00513799|Secondary|Number of Participants Eradicated of S. Aureus Carriage - 4 Months After Intervention|Eradication is defined as the absence of S. aureus carriage at the 3 sampled body sites (anterior nares, axilla, inguinal folds) of the index patient. Samples obtained by study team at follow-up visit.|4 month follow-up|||Participants|||Number
746131|NCT00513799|Secondary|Number of Participants With Recurrent Staphylococcus Aureus Skin or Soft Tissue Infection|Recurrent Staphylococcus aureus Skin or Soft Tissue Infection is defined as incidence of skin abscess, impetigo, cellulitis, or spider bite in the 1 month following intervention. Infections reported by participant at follow-up visit.|1, 4 and 6 month follow-ups|Groups 1/4 have 1 more participant analyzed each than in participant flow module due to data collected by phone. They did not return to hospital for followup (colonization swabs were not obtained). Group 3 has 1 less participant analyzed than in participant flow module due to missing data point on followup survey. They were not able to be reached.||Participants|||Number
746132|NCT00513799|Primary|Number of Participants Eradicated of S. Aureus Carriage - 1 Month After Intervention|Eradication is defined as the absence of S. aureus carriage at the 3 sampled body sites (anterior nares, axilla, inguinal folds) of the index patient. Samples obtained by study team at follow-up visit.|1 month follow-up|||Participants|||Number
746133|NCT00514020|Primary|"Number of Patients With Each Response in Good Risk Genotype (Thymidylate Synthase Promoter Enhancer Region [TSER]*2/*2 or TSER*2/*3 Genotype [Low TS Expression])"|Per RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) > 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions. This is a one-time assessment.|every 8 weeks to progression|"Patients available for measurement of response. All patients who received Oxaliplatin + Leucovorin + 5-Fluorouracil are in the heterozygous good risk genotype group. One patient was not evaluable for response."||participants|||Number
746134|NCT00514137|Secondary|Toxicity|Assessed per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Included are the toxicities at least possibly related to the study drug.|From the time of first treatment to up to 30 days after the last day of study drug treatment|||participants|||Number
746135|NCT00514137|Secondary|Duration of Response|The distribution of duration of response will be estimated using the method of Kaplan-Meier.|From the documentation of response until the date of progression|No analysis was done because there were no confirmed responses.|||||
746136|NCT00514137|Secondary|Event-free Survival|The distribution of progression-free survival will be estimated using the method of Kaplan-Meier.|Time from registration to progression or death due to any cause, assessed up to 3 years|||months||95% Confidence Interval|Median
746137|NCT00514137|Primary|The Number of Confirmed Responses (Complete Response [CR], Very Good Partial Response [VGPR], or Partial Response [PR])|"A confirmed response is defined as a patient who has achieved response and maintained it on two consecutive evaluations at least 2 weeks apart.
A Complete Response (CR) is defined as the complete disappearance of an M-protein and fewer than 5% bone marrow plasmacytosis.
A Hematologic Very good partial response (VGPR) is defined as having a ≥ 90% reduction of M-protein from serum, a Urine M-spike to be ≤ 100 mg/24 hours, and a disappearance of soft tissue plasmacytomas.
A Partial Response (PR) is defined as having a 50-89% reduction in the level of the serum monoclonal protein, a reduction in 24-hour urinary light chain excretion either by ≥90% or to <200 mg, and a ≥ 50% reduction in size of soft tissue plasmacytoma."|Every 6 weeks from the first initiation of therapy up to 72 weeks|All 13 participants were evaluable for a response||participants|||Number
746138|NCT00514215|Secondary|Immune Function and Cancer-specific Response|CT-guided biopsy & Peritumoral GM-CSF|Days 1 & 32||||||
746151|NCT00520767|Secondary|Change in Quality of Life From Baseline as Assessed by the Functional Assessment of Cancer Therapy-Neurotoxicity Questionnaire.||At the start of each cycle||||||
746139|NCT00514215|Secondary|Toxicity|CBC, sodium, potassium, BUN, serum creatinine, calcium, glucose, SGOT, Alk Phos, bilirubin, Electrolytes, Albumin (Alb), Alanine transaminase (ALT), Aspartate transaminase (AST), Alkaline phosphatase (ALP), Total bilirubin (TBIL), Direct bilirubin (Conjugated Bilirubin), Gamma glutamyl transpeptidase (GGT)|Days 11, 32, 43, & 63||||||
746140|NCT00514215|Secondary|Clinical Response as Measured by CT Criteria|CT-guided biopsy|Days 1 & 32||||||
746141|NCT00514215|Primary|Immunologic Response as Measured by ELISPOT Assay and Flow Cytometry|CT-guided biopsy & Peritumoral GM-CSF|Days 1 & 32|Patients who had metastatic Renal Cell carcinoma||percentage of participants||90% Confidence Interval|Number
746142|NCT00520741|Secondary|Patient's Global Impression of Change (PGIC) From Baseline To Last Visit|"For the assessment of the Patient’s Global Impression of Change, the subject should provide his/her assessment of his/her own clinical status, compared to Baseline, including an evaluation of seizure frequency and intensity, the occurrence of AEs, and subject’s functional status.The subject was asked to answer the following:
Over the past 4 weeks, how have you felt compared to before you entered this clinical trial? (Please check the number that best describes your condition.)
Very much improved
Much improved
Minimally improved
No change
Minimally worse
Much worse
Very much worse"|Baseline; Last Visit (approximately 27 weeks)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS included subjects who completed the Titration Phase and started withdrawing background Anti-epileptic Drugs (AEDs) (eg, entered the Maintenance Phase and took at least 1 dose of Maintenance medication).||participants|||Number
746143|NCT00520741|Secondary|Clinical Global Impression of Change (CGIC) From Baseline To Last Visit|"For the assessment of the Clinical Global Impression of Change (CGIC), the investigator should provide his/her assessment of the subject’s clinical status, compared to Baseline, including an evaluation of seizure frequency and intensity, the occurrence of AEs, and subject’s functional status. He was asked the following:Please check the number that best describes the subject’s condition over the past 4 weeks compared to Baseline:
Very much improved
Much improved
Minimally improved
No change
Minimally worse
Much worse
Very much worse"|Baseline; Last Visit (approximately 27 weeks)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS included subjects who completed the Titration Phase and started withdrawing background Anti-epileptic Drugs (AEDs) (eg, entered the Maintenance Phase and took at least 1 dose of Maintenance medication).||participants|||Number
746144|NCT00520741|Secondary|Duration of Monotherapy Treatment During the Monotherapy Phase of The Maintenance Period (Visit 9 - Visit 12)|Days on Monotherapy Treatment were defined as the number of days during the Monotherapy Phase when the subject took Lacosamide (LCM) only (ie, the total number of days exposed to LCM during the Monotherapy Phase minus any days where a concomitant or rescue Anti-epileptic Drug (AED) was taken by the subject). The days on Monotherapy Treatment did not need to be consecutive.|Visit 9 - Visit 12 (approximately 10 weeks)|The Analysis Population refers to a subset of the Full Analysis Set (FAS). The FAS included subjects who completed the Titration Phase and started withdrawing background Anti-epileptic Drugs (AEDs).This subset of the FAS included subjects who entered the Maintenance Phase but who never achieved Lacosamide (LCM) monotherapy.||days||Full Range|Median
746145|NCT00520741|Secondary|Percentage of Subjects (Using Kaplan-Meier) Who Are Identified as Meeting at Least 1 Pre-defined Exit Criteria by Day 112, Withdrew Due to Adverse Event (AE) or Withdrew Due to Lack of Efficacy During The Maintenance Period|"Subjects were classified as having an exit event if they experienced at least 1 of the following events during the Maintenance Phase as of Day 112:
Met at least 1 exit criterion based on the calculations applied for the Primary Efficacy Analysis
Withdrawal due to AE with onset during the Maintenance Phase
Withdrew prematurely due to lack of efficacy during the Maintenance Phase
The date the subject experienced the event was set to the earliest date the subject met an exit criterion or the date of the last Maintenance Phase dose for subjects not meeting an exit criterion but withdrawing due to an AE or lack of efficacy.
The secondary analysis is only conducted on the Lacosamide 400 mg/day group."|16 Weeks Maintenance Period (approximately 112 days)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS included subjects who completed the Titration Phase and started withdrawing background Anti-epileptic Drugs (AEDs) (eg, entered the Maintenance Phase and took at least 1 dose of Maintenance medication).||percentage of subjects|||Number
746146|NCT00520741|Secondary|Time to First Occurrence of Any Exit Event During The Maintenance Period|The time to first occurrence (days) of any exit event was estimated using Kaplan-Meier methods and was based on the time from the start of the Maintenance Phase to the earliest date a subject met an exit criterion. Subjects who discontinued during the Maintenance Phase due to non-exit criteria reasons or who completed the Maintenance Phase before 112 days and did not meet an exit criterion were censored as of the last Maintenance Phase dose date. Subjects completing 112 days in the Maintenance Phase were censored as of Day 112.|16 Weeks Maintenance Period (approximately 112 days)|The Analysis Population refers to a subset of the Full Analysis Set (FAS). The FAS included subjects who completed the Titration Phase and started withdrawing background Anti-epileptic Drugs (AEDs). In addition to being a member of FAS, subjects also met at least one of the exit criterion noted under the Primary Outcome Measure.||days||Full Range|Median
746147|NCT00520741|Primary|Percentage of Subjects (Using Kaplan-Meier) Who Are Identified As Meeting At Least 1 Pre-defined Exit Criteria By Day 112 Relative To The Start of Withdrawal of Background Antiepileptic Drug(s)|"Pre-defined exit criteria:
A 2-fold or greater increase in average monthly (28-day) partial seizure frequency (motor and non-motor) compared to average monthly partial seizure frequency (motor and non-motor) during the Baseline Phase
A 2-fold or greater increase in consecutive 2-day partial seizure frequency (motor and non-motor) versus the highest consecutive 2-day partial seizure frequency (motor and non-motor) that occurred during the Baseline Phase.
Note: if the highest consecutive 2-day partial seizure frequency during the Baseline Phase is 1, a 2-day partial seizure frequency of ≥3 is required to meet this exit criterion
Occurrence of a single generalized tonic-clonic seizure if none had occurred in the 6 months prior to randomization
A prolongation or worsening of overall seizure duration, frequency, type or pattern considered by the investigator as serious enough to warrant trial discontinuation
Status epilepticus, or new onset of serial/cluster seizures"|16 Weeks Maintenance Period (approximately 112 days)|"The Analysis Population refers to the Full Analysis Set (FAS). The FAS included subjects who completed the Titration Phase and started withdrawing background Anti-epileptic Drugs (AEDs) (ie, entered the Maintenance Phase and took at least 1 dose of Maintenance medication).
The primary analysis is only conducted on the Lacosamide 400 mg/day group."||percentage of subjects|||Number
746148|NCT00520767|Secondary|Overall Hematologic Response Rate (OHR)||Beginning of cycles 4, 8, 12, 16 and 20, at follow up and end of study.||||||
746157|NCT00520845|Secondary|Time to Progression|Estimated probable duration from on‐study date to date of disease progression, using the Kaplan‐Meier method with censoring (see analysis population description for additional details). Disease progression is defined under RECIST v1.1 as >=20% increase in sum of longest diameters of target lesions, unequivocal progression of non‐target lesions, or appearance of new lesions.|2 years from date of registration|All patients are included in the analysis on intention‐to-treat basis. Analysis is by Kaplan‐Meier method, where progression is an event, with censoring for non-progressed patients at greater of off‐study date, last known alive date, or date of death not attributable to disease progression.||days||95% Confidence Interval|Median
746158|NCT00520845|Secondary|Overall Response Rate|Overall response rate is measured by complete response + partial response. Number of patients in each response category, per RECIST v1.1, summarized as follows for target lesion criteria (see RECIST v1.1 for additional details): complete response (CR),disappearance of target lesions; partial response (PR), >=30% decrease in sum of longest diameter of target lesions; progressive disease (PD), >=20% increase in sum of LD of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or SD. Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR>PR>SD>PD.|On‐treatment date to date of disease progression (assessed at 6 weeks up to 2 years)|All patients with best overall response data; patients are excluded if best overall response data is missing or if the patient is not evaluable for best overall response.||participants||95% Confidence Interval|Number
746159|NCT00520845|Primary|Median Survival|Estimated probable duration of life from on‐study date to date of death from any cause, using the Kaplan‐Meier method with censoring (see analysis population description for additional details)|2 years from date of registration|All patients are included in the analysis on intention‐to-treat basis. Analysis is by Kaplan‐Meier method, where death is an event, with censoring for non‐expired patients at greater of off‐study date or last known alive date.||days||95% Confidence Interval|Median
746160|NCT00520936|Secondary|Pharmacogenomics - Measure the Response of Genes Related to Toxicity|The pharmacogenomics outcomes examining the correlation between the presence of the methylene tetrahydrofolate reductase gene and the presence of a polymorphism in the thymidylate synthase (TS) gene and/or gene promoter and toxicity were optional and will not be reported here. Results of this optional research may be reported in the future by the Children's Oncology Group in the peer-reviewed literature.|baseline|The pharmacogenomics outcomes examining the correlation between the presence of the methylene tetrahydrofolate reductase gene and the presence of a polymorphism in the thymidylate synthase (TS) gene and/or gene promoter and toxicity were optional and will not be reported here.||Correlation coefficient|||Number
746161|NCT00520936|Secondary|Number of Patients With Adverse Events, Discontinuations, or Deaths Possibly Due to Study Drug|AdEERS= Adverse Event Expedited Reporting System; AE = adverse event. Patients may be counted in more than 1 category. Includes events that were considered possibly related to study drug (PRSD) as judged by the investigator.|every cycle (up to 2 years and 7 months)|All treated participants.||Participants|||Number
746162|NCT00520936|Primary|Percentage of Participants With Overall Tumor Response (Response Rate)|Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response = disappearance of all target lesions. Partial Response = 30% decrease in sum of longest diameter of target lesions. Response rate (percent [%])= (number of participants with complete response (CR) or partial response (PR) in stratum/number of participants in stratum)*100.|baseline to measured progressive disease (up to 1 year)|All treated participants.||Percentage of Participants|||Number
746163|NCT00520975|Other Pre-specified|VEGF Levels in Breast Tumor by Immunohistochemistry Assay (Tumor Sample Has Not Been Analyzed Yet, no Results Could be Reported)|Tissue sections from the primary or metastatic paraffin blocks were subjected to VEGF immunohistochemistry (IHC). The VEGF cytoplasmic staining intensity was evaluated semiquantitavely using a classification from 0 to 3, with 0 representing lack of staining, 1 = low staining intensity, 2 = intermediate staining intensity and 3 = strong staining intensity. The fraction of positively staining cells will be determined as well (0 = lack of staining, 1 ≤ 1% cell staining, 2 = 1 – 10% cell staining, 3 = 10 – 50% cell staining, 4 = 50 – 90% cells staining and 5 ≤ 90% cells staining) (48). Staining intensity score zero and fraction of positively staining cells of ≤ 1% (scores zero and 1) will be considered as absence of staining and therefore negative overexpression of VEGF.|assessed at baseline||||||
746164|NCT00520975|Other Pre-specified|Number of Circulating Tumor Cells at Baseline|Number of circulating tumor cells per 7.5mL blood were counted prior to starting protocol therapy|assessed at baseline prior to starting protocol therapy|Patients who had blood sample drawn at baseline prior to starting protocol therapy||number of cells per 7.5 mL blood||Full Range|Median
746165|NCT00520975|Other Pre-specified|Change in Level of Experiencing Side Effects Between Baseline and Cycle 6 Induction|Participants indicated their level of experiencing side effects across 1 item (Functional Assessment of Cancer Therapy [FACT] item G5) on a 5-point Likert scale ranging from 0 (not at all) to 4(very much). Total score per patient, ranged from 0 to 4 with a higher score representing better quality of life (QOL).|assessed at baseline and at cycle 6 induction prior to starting maintenance therapy|All patients who reported their level of experiencing side effects using FACT item G5 at both baseline and cycle 6 induction||scores on a scale||Full Range|Median
746166|NCT00520975|Other Pre-specified|Change in Neurotoxicity Level Between Baseline and Cycle 6 Induction|Participants indicated their level of neurotoxicity symptoms across 4 items using the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) scale, each item on a 5-point Likert scale ranging from 0 (not at all) to 4(very much). Total score per patient ranged from 0 to 16 with higher scores representing fewer neurotoxic symptoms.|assessed at baseline and at cycle 6 induction prior to starting maintenance therapy|All patients who reported their neurotoxicity level using FACT/GOG-Ntx scale at both baseline and cycle 6 induction||scores on a scale||Full Range|Median
746167|NCT00520975|Other Pre-specified|Change in FACT/NCCN Breast Symptom Index (FBSI) Between Baseline and Cycle 6 Induction|Participants indicated their level of breast symptoms across 8 items using the Functional Assessment of Cancer Therapy/National Comprehensive Cancer Network (FACT/NCCN) FBSI scale, each item on a 5-point Likert scale ranging from 0 (not at all) to 4(very much). Total score per patient, ranged from 0 to 32 with higher scores representing fewer symptoms.|assessed at baseline and at cycle 6 induction prior to starting maintenance therapy|All patients who reported their fatigue level using FACIT Fatigue subscale at both baseline and cycle 6 induction||scores on a scale||Full Range|Median
746168|NCT00520975|Other Pre-specified|Change in Fatigue Level Between Baseline and Cycle 6 Induction|Fatigue level was measured using Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue subscale. Participants indicated their level of fatigue across 13 items, each item on a 5-point Likert scale ranging from 0 (not at all) to 4(very much). Total score per patient was calculated by taking the reverse of each item (unless specified not to), taking the sum of those items, multiplying the sum by the number of items in the scale, and then dividing that number by the number of answered items. Total score ranged from 0 to 52 with higher scores representing less fatigue.|assessed at baseline and at cycle 6 induction prior to starting maintenance therapy|All patients who reported their fatigue level using FACIT Fatigue subscale at both baseline and cycle 6 induction||scores on a scale||Full Range|Median
746169|NCT00520975|Secondary|Number of Patients Experiencing Congestive Heart Failure|Clinical congestive heart failure (CHF) was assessed using Left Ventricular Ejection Fraction (LVEF) and symptom information via the Cardiac Toxicity Form as well as symptom information collected via the Adverse Event Form. Clinical CHF was defined as symptomatic decline in LVEF to below the lower limit of normal (LLN) or symptomatic diastolic dysfunction.|assessed every 3 months while on treatment and at 3 months post treatment|All patients who began protocol treatment||participants|||Number
746170|NCT00520975|Secondary|Overall Response Rate|Overall response rate is defined as number of patients with complete response (CR) or partial response (PR) divided by all randomized patients. Responses are evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline. CR is defined as disappearance of all target and non-target lesions. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameters), and/or persistence of one or more non-target lesion(s).|assessed at baseline, every 12 weeks while on treatment, then very 3 months if patient is <2 years from study entry, every 6 months if 2-5 years from study entry, and annually if 6-10 years from study entry until disease progression|All randomized patients||proportion of participants||95% Confidence Interval|Number
746171|NCT00520975|Secondary|Proportion of Progression-free at 6 Months|Disease progression was defined using the Response Evaluation Criteria in Solid Tumours (RECIST) version 1.0, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Proportion of progression-free at 6 months was calculated using the Kaplan-Meier method.|assessed at baseline, at 3 and 6 months after study entry|All randomized patients||proportion of participants||95% Confidence Interval|Number
746172|NCT00520975|Secondary|Overall Survival|Overall survival (OS) is defined as the time from randomization until death (event), or censored at last date known alive. Kaplan-Meier method was used to estimate the median OS.|assessed every 3 months for patients within 2 years of registration, every 6 months for patients 3-5 years from registration and then yearly for up to10 years|All randomized patients||Months||95% Confidence Interval|Median
746173|NCT00520975|Primary|Progression-free Survival|Progression-free survival (PFS) was defined as time from date of randomization to first disease progression, new second breast primaries, or to death from any cause, whichever occurred first, otherwise cases were censored at date last documented to be free of progression. Disease progression was defined using the Response Evaluation Criteria in Solid Tumours (RECIST) version 1.0, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Kaplan-Meier method was used to estimate the median PFS.|assessed every 3 months for patients within 2 years of registration, every 6 months for patients 3-5 years from registration and then yearly for up to10 years|All randomized patients||Months||95% Confidence Interval|Median
746174|NCT00521001|Secondary|Confirmed Response Rate (Complete Response and Partial Response)|Confirmed response rates will be evaluated by dividing the number of confirmed responders (i.e. patients that achieve a CR or PR on consecutive evaluations) by the total number of evaluable patients. Confidence intervals for the true response rate will be calculated using the properties of the binomial distribution.|Up to 5 years|||percentage of confirmed responses||95% Confidence Interval|Number
746175|NCT00521001|Secondary|Time to Disease Progression|Time to disease progression is defined as the time from registration to the earliest date documentation of disease progression. If a patient dies without a documentation of disease progression the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death. The distribution of time to progression will be estimated using the method of Kaplan-Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Time from registration to the earliest date documentation of disease progression; Up to 5 years|||months||95% Confidence Interval|Median
746176|NCT00521001|Secondary|Survival Time|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.|Time from registration to death due to any cause; Up to 5 years|||months||95% Confidence Interval|Median
746177|NCT00521001|Primary|9-week Progression-free Survival Rate|The primary endpoint of this trial is the 9 week PFS rate. A patient is a success if they are progression free at their cycle 2 evaluation (approximately 9 weeks post registration). All patients, who meet the eligibility criteria, sign a consent form, and start treatment will be included in the evaluation of the 9-week PFS rate (evaluable patients). The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated using the properties of the binomial distribution. If some patients are lost to follow up prior to their cycle 2 evaluation, the Kaplan-Meier method will be used to estimate the 9 week PFS rate. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|at 9 weeks|||proportion of patients||95% Confidence Interval|Number
746178|NCT00521014|Primary|Progression-free Survival Rate|"after autologous stem cell transplantation (ASCT). Disease progression is defined using International Workshop Criteria for non-Hodgkin lymphoma37 and is defined as:
≥ 50% increase in products of diameters of any previously identified abnormal node or nodule AND/OR
appearance of any new lesions"|up to 3 years|||years||Full Range|Mean
752321|NCT00558272|Secondary|N-desmethyl Metabolite of Saracatinib: Maximum Plasma Concentration at Steady State (Css,Max)||Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29|||ng/ml||Full Range|Median
746179|NCT00521339|Secondary|Mean Residence Time (MRT) During the Extension Phase|Mean Residence Time (MRT) is defined as the mean duration of time the drug spends in the body. The average concentration at steady state (Cavg) (for Days169/170) was calculated as follows: Cavg = (Day 169/170)/(12)|Day 169 pre-dose, 0.5, 1, 2, 4, 8 12, 24 and 36 hours after AM dose|Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma concentration data for apremilast.||hours||Geometric Coefficient of Variation|Geometric Mean
746180|NCT00521339|Secondary|Accumulation Index During the Extension Phase|Accumulation represents the relationship between the dosing interval and the rate of elimination for the drug.|Day 169 pre-dose, 0.5, 1, 2, 4, 8 12, 24 and 36 hours after AM dose|Not able to calculate the Accumulation Index at this time point; insufficient data collection for this calculation.|||||
746181|NCT00521339|Secondary|Apparent Total Volume of Distribution During the Terminal Phase After Extravascular Administration (Vz/F) During the Extension Phase|For Days 169/170, apparent volume of distribution of drug (V/z) based on the terminal phase was calculated as follows: Vz/F=Dose/(λ*AUC12) where λ = the terminal elimination rate constant|Day 169 pre-dose, 0.5, 1, 2, 4, 8 12, 24 and 36 hours after AM dose|Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma concentration data for apremilast.||mL||Geometric Coefficient of Variation|Geometric Mean
746182|NCT00521339|Secondary|Apparent Total Clearance of Apremilast From Plasma After Extravascular Administration (CL/F) During the Extension Phase|For 169/170, apparent clearance of drug from plasma after extravascular administration (CL/F) was calculated as follows: CL/F= Dose/AUC12|Day 169 pre-dose, 0.5, 1, 2, 4, 8 12, 24 and 36 hours after AM dose|Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma concentration data for apremilast. This analysis was performed for participants with normal renal function only.||mL/hour||Geometric Coefficient of Variation|Geometric Mean
746183|NCT00521339|Secondary|Terminal Phase Elimination Half Life of Apremilast (t½) During the Extension Phase|Terminal phase elimination half-life (t1/2) was calculated as follows: t1/2 = 0.693/λz. The terminal elimination rate constant (λZ) was estimated by linear regression of the log-transformed concentration-time data.|Day 169 pre-dose, 0.5, 1, 2, 4, 8 12, 24 and 36 hours after AM dose|Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma concentration data for Apremilast.||hours||Geometric Coefficient of Variation|Geometric Mean
746184|NCT00521339|Secondary|Time to Maximum Plasma Concentration (Tmax) During the Extension Phase|The time to reach Cmax (Tmax) was obtained directly from the observed concentration-time data on Day 169/170. Actual times utilized were used for reporting Tmax values.|Day 169 pre-dose, 0.5, 1, 2, 4, 8 12, 24 and 36 hours after AM dose|Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma concentration data for Apremilast.||hours||Geometric Coefficient of Variation|Geometric Mean
746185|NCT00521339|Secondary|Peak (Maximum) Plasma Concentration of Apremilast (Cmax) During the Extension Phase|The maximum observed plasma concentration of CC-10004 (Cmax); the maximum plasma concentration (Cmax) was obtained directly from the observed concentration-time data on Days 169/170.|Day 169 pre-dose, 0.5, 1, 2, 4, 8 12, 24 and 36 hours after AM dose|Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma concentration data for Apremilast.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
746186|NCT00521339|Secondary|Area Under the Plasma Concentration Time-curve From 0 to 12 Hours Post Dose (AUC 0-12) During the Extension Phase|Plasma concentrations of apremilast were determined using validated chiral liquid chromatography-mass spectrometry methods (LC-MS/MS).|Day 169 pre-dose, 0.5, 1, 2, 4, 8 12, 24 and 36 hours after AM dose|Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma concentration data for apremilast.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
746187|NCT00521339|Secondary|Change From Baseline in the Medical Outcome Study Short Form 36-item Health Survey (SF-36) Scores, Mental and Physical Components to Week 12|The SF-36 was a self-administered instrument consisting of 8 multi-item scales that assess 8 health domains: 1) limitations in physical activities because of health problems; 2) limitations in social activities because of physical or emotional problems; 3) limitations in usual role activities because of physical health problems; 4) bodily pain; 5) general mental health (psychological distress and well-being); 6) limitations in usual role activities because of emotional problems; 7) vitality (energy and fatigue); and 8) general health perceptions. A higher score post-baseline is indicative of improvement in the disease state. The summary physical health score included physical functioning, role-physical, bodily pain and general health. The summary mental health score included: vitality, social functioning, role-emotional and mental health. The resulting score for each subscale is then standardized, to obtain values ranging from 0 to 100, with higher values indicating a better QOL.|Baseline to Week 12|Safety population consisted of all participants who were enrolled and received at least one dose of study medication. If participant had a missing evaluation for any time point assessments, the last observation carried forward (LOCF) method of imputation was used.||units on a scale||Standard Deviation|Mean
746188|NCT00521339|Secondary|Change From Baseline in the Dermatology Life Quality Index (DLQI) at Week 12|DLQI was the dermatology-specific quality of life (QOL) measure used for the psoriatic population. The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on a participants QoL, based on recall over the past week. Domains include symptoms, feelings, daily activities, leisure, work, personal relationships, and treatment. Possible responses for each of the 10 items are: not at all, a little, a lot, and very much. Each question is rated on a scale of 0 to 3 with a total range of 0 to 30. Higher scores indicate greater impact of disease on QOL|Baseline to Week 12|Only those with both a baseline and final/termination visit assessment were included in the analyses of change from baseline. Safety population consisted of all participants who were enrolled and received at least one dose of study medication.||units on a scale||Standard Deviation|Mean
746189|NCT00521339|Secondary|Percent Change From Baseline in the Dendritic Cell (CD83) Inflammatory Marker in Psoriatic Skin Biopsies|Inflammatory markers associated with psoriasis (using skin biopsies) were used to detect acute inflammation and as markers of treatment response. The inflammatory markers were measured using Reverse transcriptase polymerase chain reaction (RT-PCR) and the messenger Ribonucleic acid (mRNA) is being measured.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Inflammatory Marker in Psoriatic Skin Biopsies at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.||percent change||Full Range|Median
756035|NCT00591344|Secondary|50 Foot Walk Speed|The speed that aerson walks over 50 feet|Obtained during initial evaluation & then every 6 six months to end of 2-yr training period||||||
746190|NCT00521339|Secondary|Percent Change From Baseline in the IL2 Inflammatory Marker in Psoriatic Skin Biopsies|Inflammatory markers associated with psoriasis (using skin biopsies) were used to detect acute inflammation and as markers of treatment response. The inflammatory markers were measured using Reverse transcriptase polymerase chain reaction (RT-PCR) and the messenger Ribonucleic acid (mRNA) is being measured.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Inflammatory Marker in Psoriatic Skin Biopsies at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.||percent change||Full Range|Median
746191|NCT00521339|Secondary|Percent Change From Baseline in the Chemokine Ligand (CXCL9) Inflammatory Marker in Psoriatic Skin Biopsies|Inflammatory markers associated with psoriasis (using skin biopsies) were used to detect acute inflammation and as markers of treatment response. The inflammatory markers were measured using Reverse transcriptase polymerase chain reaction (RT-PCR) and the messenger Ribonucleic acid (mRNA) is being measured.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Inflammatory Marker in Psoriatic Skin Biopsies at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.||percent change||Full Range|Median
746192|NCT00521339|Secondary|Percent Change From Baseline in the IL10 Inflammatory Marker in Psoriatic Skin Biopsies|Inflammatory markers associated with psoriasis (using skin biopsies) were used to detect acute inflammation and as markers of treatment response. The inflammatory markers were measured using Reverse transcriptase polymerase chain reaction (RT-PCR) and the messenger Ribonucleic acid (mRNA) is being measured.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Inflammatory Marker in Psoriatic Skin Biopsies at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.||percent change||Full Range|Median
746193|NCT00521339|Secondary|Percent Change From Baseline in the Interferon (INF) Gamma Inflammatory Marker in Psoriatic Skin Biopsies|Inflammatory markers associated with psoriasis (using skin biopsies) were used to detect acute inflammation and as markers of treatment response. The inflammatory markers were measured using Reverse transcriptase polymerase chain reaction (RT-PCR) and the messenger Ribonucleic acid (mRNA) is being measured.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Inflammatory Marker in Psoriatic Skin Biopsies at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.||percent change||Full Range|Median
746194|NCT00521339|Secondary|Percent Change From Baseline in the Tumor Necrosing Factor (TNF) Alpha Inflammatory Marker in Psoriatic Skin Biopsies|Inflammatory markers associated with psoriasis (using skin biopsies) were used to detect acute inflammation and as markers of treatment response. The inflammatory markers were measured using Reverse transcriptase polymerase chain reaction (RT-PCR) and the messenger Ribonucleic acid (mRNA) is being measured.|Week 0 to Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Inflammatory Marker in Psoriatic Skin Biopsies at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.||percent change||Full Range|Median
746195|NCT00521339|Secondary|Percent Change From Baseline in the IL17A Inflammatory Marker in Psoriatic Skin Biopsies|Inflammatory markers associated with psoriasis (using skin biopsies) were used to detect acute inflammation and as markers of treatment response. The inflammatory markers were measured using Reverse transcriptase polymerase chain reaction (RT-PCR) and the messenger Ribonucleic acid (mRNA) is being measured.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Inflammatory Marker in Psoriatic Skin Biopsies at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.||percent change||Full Range|Median
746196|NCT00521339|Secondary|Percent Change From Baseline in the MX1 (Gene That Encodes the Interferon-induced p78 Protein) Inflammatory Marker in Psoriatic Skin Biopsies|Inflammatory markers associated with psoriasis (using skin biopsies) were used to detect acute inflammation and as markers of treatment response. The inflammatory markers were measured using Reverse transcriptase polymerase chain reaction (RT-PCR) and the messenger Ribonucleic acid (mRNA) is being measured.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Inflammatory Marker in Psoriatic Skin Biopsies at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.||percent change||Full Range|Median
746197|NCT00521339|Secondary|Percent Change From Baseline in the IL8 Inflammatory Marker in Psoriatic Skin Biopsies|Inflammatory markers associated with psoriasis (using skin biopsies) were used to detect acute inflammation and as markers of treatment response. The inflammatory markers were measured using Reverse transcriptase polymerase chain reaction (RT-PCR) and the messenger Ribonucleic acid (mRNA) is being measured.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Inflammatory Marker in Psoriatic Skin Biopsies at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.||percent change||Full Range|Median
746198|NCT00521339|Secondary|Percent Change From Baseline in the pluripotent19 (P19) Inflammatory Marker in Psoriatic Skin Biopsies|Inflammatory markers associated with psoriasis (using skin biopsies) were used to detect acute inflammation and as markers of treatment response. The inflammatory markers were measured using Reverse transcriptase polymerase chain reaction (RT-PCR) and the messenger Ribonucleic acid (mRNA) is being measured.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Inflammatory Marker in Psoriatic Skin Biopsies at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.||percent change||Full Range|Median
746199|NCT00521339|Secondary|Percent Change From Baseline in the keratin16 (K16) Inflammatory Marker in Psoriatic Skin Biopsies|Inflammatory markers associated with psoriasis (using skin biopsies) were used to detect acute inflammation and as markers of treatment response. The inflammatory markers were measured using Reverse transcriptase polymerase chain reaction (RT-PCR) and the messenger Ribonucleic acid (mRNA) is being measured.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Inflammatory Marker in Psoriatic Skin Biopsies at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.||percent change||Full Range|Median
747588|NCT00530842|Secondary|Static Lung Volumes (Percent)|Post-dose RV/TLC (Residual Volume over Total Lung Capacity) after 4 weeks (measured by bodyphlethysmography)|4 weeks|FAS using imputed values||Percent of RV over TLC||Standard Error|Mean
746200|NCT00521339|Secondary|Percent Change From Baseline in the Defensin Beta 4 (DEFB4) Inflammatory Marker in Psoriatic Skin Biopsies|Inflammatory markers associated with psoriasis (using skin biopsies) were used to detect acute inflammation and as markers of treatment response. The inflammatory markers were measured using Reverse transcriptase polymerase chain reaction (RT-PCR) and the messenger Ribonucleic acid (mRNA) i being measured.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Inflammatory Marker in Psoriatic Skin Biopsies at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.||percent change||Full Range|Median
746201|NCT00521339|Primary|Treatment Emergent Adverse Events (TEAEs) During the Extension Phase|"TEAE = any AE occurring or worsening on or after the first treatment with any study drug. Related = suspected by investigator to be related to study treatment. National Cancer Institute [NCI] Common Toxicity Criteria for Adverse Events [CTCAE], Version 3.0, grades: 1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, 5 = death.
Adverse event (AE) = any noxious, unintended, or untoward medical occurrence occurring at any dose that may appear or worsen in a participant during the course of a study, including new intercurrent illness, worsening concomitant illness, injury, or any concomitant impairment of participant's health, including laboratory test values, regardless of etiology. Serious adverse event (SAE) = any AE which: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event."|Week 12 to Week 24|Safety population consisted of all participants who were enrolled and received at least one dose of study medication in treatment Extension Phase.||participants|||Number
746202|NCT00521339|Secondary|Percent Change From Baseline in the p40 Inflammatory Marker in Psoriatic Skin Biopsies|Inflammatory markers associated with psoriasis (using skin biopsies) were used to detect acute inflammation and as markers of treatment response. The inflammatory markers were measured using Reverse transcriptase polymerase chain reaction (RT-PCR) and the messenger Ribonucleic acid (mRNA) is being measured.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Inflammatory Marker in Psoriatic Skin Biopsies at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.||percent change||Full Range|Median
746203|NCT00521339|Secondary|Percent Change From Baseline in the Interleukin (IL) IL-22 Inflammatory Marker in Psoriatic Skin Biopsies|Inflammatory markers associated with psoriasis (using skin biopsies) were used to detect acute inflammation and as markers of treatment response. The inflammatory markers were measured using Reverse transcriptase polymerase chain reaction (RT-PCR) and the messenger Ribonucleic acid (mRNA) is being measured.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Inflammatory Marker in Psoriatic Skin Biopsies at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.||percent change||Full Range|Median
746204|NCT00521339|Secondary|Percent Change From Baseline in the Inducible Nitric Oxide (iNOS) Inflammatory Marker in Psoriatic Skin Biopsies|Inflammatory markers associated with psoriasis (using skin biopsies) were used to detect acute inflammation and as markers of treatment response. The inflammatory markers were measured using Reverse transcriptase polymerase chain reaction (RT-PCR) and the messenger Ribonucleic acid (mRNA) is being measured.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Inflammatory Marker in Psoriatic Skin Biopsies at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.||percent change||Full Range|Median
746205|NCT00521339|Secondary|Percent Change From Baseline of Epidermal Thickness in the Psoriatic Skin Biopsy at Week 12|The aim of the study was to measure the pharmacodynamic effects of apremilast in participants with plaque psoriasis in skin affected by psoriasis, immune cells enter the skin through blood vessels and cause the epidermis to grow very rapidly and to stop shedding properly. This causes thickening of the skin as well as the scaly build up composed of dead skin cells seen on areas affected by psoriasis.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Psoriatic Skin Biopsy at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.||percent change||Full Range|Median
746206|NCT00521339|Secondary|Percent Change From Baseline of Langerin in the Epidermis of the Psoriatic Skin Biopsy at Week 12|The aim of the study was to measure the pharmacodynamic effects of apremilast in participants with plaque psoriasis in skin affected by psoriasis, immune cells enter the skin through blood vessels and cause the epidermis to grow very rapidly and to stop shedding properly. This causes thickening of the skin as well as the scaly build up composed of dead skin cells seen on areas affected by psoriasis.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Psoriatic Skin Biopsy at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.||percent change||Full Range|Median
746207|NCT00521339|Secondary|Percent Change From Baseline of Langerin in the Dermis of Psoriatic Skin Biopsy at Week 12|The aim of the study was to measure the pharmacodynamic effects of apremilast in participants with plaque psoriasis in skin affected by psoriasis, immune cells enter the skin through blood vessels and cause the epidermis to grow very rapidly and to stop shedding properly. This causes thickening of the skin as well as the scaly build up composed of dead skin cells seen on areas affected by psoriasis.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Psoriatic Skin Biopsy at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.||percent change||Full Range|Median
746208|NCT00521339|Secondary|Percent Change From Baseline of CD56 in the Epidermis of the Psoriatic Skin Biopsy at Week 12|The aim of the study was to measure the pharmacodynamic effects of apremilast in participants with plaque psoriasis in skin affected by psoriasis, immune cells enter the skin through blood vessels and cause the epidermis to grow very rapidly and to stop shedding properly. This causes thickening of the skin as well as the scaly build up composed of dead skin cells seen on areas affected by psoriasis.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Psoriatic Skin Biopsy at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.||percent change||Full Range|Median
747181|NCT00527982|Primary|Histological Responses|Number of patients with histological response based on changes in bronchoscopies from baseline to 12 months.|Baseline to 12 months|No analysis. One registered patient inevaluable for response, study terminated early.|||||
746209|NCT00521339|Secondary|Percent Change From Baseline of CD56 in the Dermis of the Psoriatic Skin Biopsy at Week 12|The aim of the study was to measure the pharmacodynamic effects of apremilast in participants with plaque psoriasis in skin affected by psoriasis, immune cells enter the skin through blood vessels and cause the epidermis to grow very rapidly and to stop shedding properly. This causes thickening of the skin as well as the scaly build up composed of dead skin cells seen on areas affected by psoriasis.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Psoriatic Skin Biopsy at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.||percent change||Full Range|Median
746210|NCT00521339|Secondary|Percent Change From Baseline of CD11c in the Epidermis of the Psoriatic Skin Biopsy at Week 12|The aim of the study was to measure the pharmacodynamic effects of apremilast in participants with plaque psoriasis in skin affected by psoriasis, immune cells enter the skin through blood vessels and cause the epidermis to grow very rapidly and to stop shedding properly. This causes thickening of the skin as well as the scaly build up composed of dead skin cells seen on areas affected by psoriasis.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Psoriatic Skin Biopsy at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.||percent change||Full Range|Median
746211|NCT00521339|Secondary|Percent Change From Baseline of CD 11c in the Dermis of the Psoriatic Skin Biopsy at Week 12|The aim of the study was to measure the pharmacodynamic effects of apremilast in participants with plaque psoriasis in skin affected by psoriasis, immune cells enter the skin through blood vessels and cause the epidermis to grow very rapidly and to stop shedding properly. This causes thickening of the skin as well as the scaly build up composed of dead skin cells seen on areas affected by psoriasis.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Psoriatic Skin Biopsy at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.||percent change||Full Range|Median
746212|NCT00521339|Secondary|Percent Change From Baseline of CD3 in the Epidermis of the Psoriatic Skin Biopsy at Week 12|The aim of the study was to measure the pharmacodynamic effects of apremilast in participants with plaque psoriasis in skin affected by psoriasis, immune cells enter the skin through blood vessels and cause the epidermis to grow very rapidly and to stop shedding properly. This causes thickening of the skin as well as the scaly build up composed of dead skin cells seen on areas affected by psoriasis.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Psoriatic Skin Biopsy at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.||percent change||Full Range|Median
746213|NCT00521339|Secondary|Percent Change From Baseline of CD3 in the Dermis of the Psoriatic Skin Biopsy at Week 12|The aim of the study was to measure the pharmacodynamic effects of apremilast in participants with plaque psoriasis in skin affected by psoriasis, immune cells enter the skin through blood vessels and cause the epidermis to grow very rapidly and to stop shedding properly. This causes thickening of the skin as well as the scaly build up composed of dead skin cells seen on areas affected by psoriasis.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Psoriatic Skin Biopsy at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.||percent change||Full Range|Median
746214|NCT00521339|Secondary|Change From Baseline in Peripheral Blood T Cell, B Cell, and NK Cell Subsets at Week 12|T cells or T lymphocytes, a type of white blood cell, play a role in cell-mediated immunity. T cells are distinguished from other lymphocytes by the presence of a T-cell receptor (TCR) on the cell surface and mature in the thymus. B cells, a type of lymphocyte in the humoral immunity of the adaptive immune system can be distinguished by the presence of a protein on the B cells outer surface called a B cell receptor (BCR). This receptor protein allows a B cell to bind to a specific antigen and make antibodies against antigens [(antigen-presenting cells APCs)], and to develop into memory B cells after activation by antigen interaction. Natural Killer Cells (NK) are a type of cytotoxic lymphocyte critical to the innate immune system. Their role is analogous to that of cytotoxic T cells in the vertebrate adaptive immune response. They constitute the third kind of cells differentiated from the common lymphoid progenitor generating B and T lymphocytes and mature in the bone marrow.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the peripheral blood T cell, B cell and NK cell subsets at Baseline and Week 12.||percentage of lymphocytes||Standard Deviation|Mean
746215|NCT00521339|Secondary|Mean Residence Time (MRT) During the Treatment Phase|Mean Residence Time (MRT) is defined as the mean duration of time the drug spends in the body. The average concentration at steady state (Cavg) (for Day 85 was calculated as follows: Cavg = (Day 85 AUC0-12)/(12).|Day 85 Pre-dose, 0.5, 1, 2, 4, 8, and 12 hours after the AM dose|Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma concentration data for apremilast||hours||Geometric Coefficient of Variation|Geometric Mean
746216|NCT00521339|Secondary|Accumulation Index (R)|Accumulation represents the relationship between the dosing interval and the rate of elimination for the drug.|Day 85 Pre-dose, 0.5, 1, 2, 4, 8, and 12 hours after the AM dose|Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma concentration data for apremilast.||ratio||Geometric Coefficient of Variation|Geometric Mean
746217|NCT00521339|Secondary|Apparent Total Volume of Distribution During the Terminal Phase After Extravascular Administration (Vz/F) During the Treatment Phase|"Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F) (for Days 1, 85, and 169/170)
For Day 1, Vz/F was not calculated.
For Days 85 and 169/170, apparent volume of distribution of drug (V/z) based on the terminal phase was calculated as follows: Vz/F=Dose/(λ*AUC^12)"|Day 85|Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma concentration data for apremilast.||mL||Geometric Coefficient of Variation|Geometric Mean
746218|NCT00521339|Secondary|Apparent Total Clearance of Apremilast From Plasma After Extravascular Administration (CLz/F) During the Treatment Phase|"The apparent total clearance of apremilast from plasma after extravascular administration (CLz/F); for Day 1, apparent clearance of drug from plasma (CL/F) was not calculated.
For Day 85, Apparent clearance of drug from plasma after extravascular administration (CL/F) was calculated as follows: CL/F= Dose/AUC^12 where τ=12."|Day 85 Pre-dose, 0.5, 1, 2, 4, 8, and 12 hours after the AM dose|Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma concentration data for apremilast. This analysis was performed for participants with normal renal function only.||mL/hour||Geometric Coefficient of Variation|Geometric Mean
746219|NCT00521339|Secondary|Terminal Phase Elimination Half Life of Apremilast (t½)|Terminal phase elimination half-life (t1/2) was calculated as follows: t1/2 = 0.693/λz. The terminal elimination rate constant (λZ) was estimated by linear regression of the log-transformed concentration-time data.|Day 85 Pre-dose, 0.5, 1, 2, 4, 8, and 12 hours after the AM dose|Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma concentration data for apremilast.||Liters||Geometric Coefficient of Variation|Geometric Mean
746220|NCT00521339|Secondary|Time to Maximum Plasma Concentration (Tmax) During the Treatment Phase|The time to reach Cmax (Tmax) was obtained directly from the observed concentration-time data on Day 85. Actual times utilized were used for reporting Tmax values.|Day 85 Pre-dose, 0.5, 1, 2, 4, 8, and 12 hours after the AM dose|Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma concentration data for apremilast.||hours||Full Range|Median
746221|NCT00521339|Secondary|Trough Plasma Concentration (Cmin)|The trough observed plasma concentration of apremilast (Cmin) was determined directly from the observed pre-AM dose concentration on Day 85.|Day 85 Pre-dose|Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma concentration data for apremilast||ng/mL||Geometric Coefficient of Variation|Geometric Mean
746222|NCT00521339|Secondary|Peak (Maximum) Plasma Concentration of Medication (Cmax)|The maximum observed plasma concentration of apremilast (Cmax); the maximum plasma concentration (Cmax) was obtained directly from the observed concentration-time data on Days 1, 85, and 169/170, respectively.|Day 85 Pre-dose, 0.5, 1, 2, 4, 8, and 12 hours after the AM dose|Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma concentration data for Apremilast.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
746223|NCT00521339|Secondary|Area Under the Plasma Concentration Time-curve From 0 to 12 Hours Post Dose (AUC 0-12)|Plasma concentrations of apremilast were determined using validated chiral liquid chromatography-mass spectrometry methods (LC-MS/MS). For Day 1, AUC0-12 was calculated, using linear trapezoidal area method in WinNonlin (linear-linear trapezoidal). For Days 85 and 169/170, the AUC during a dosing interval (12 hours) (AUC0-12), was calculated at steady-state using the partial area function within WinNonlin.|Day 85 Pre-dose, 0.5, 1, 2, 4, 8, and 12 hours after the AM dose|Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma concentration data for Apremilast.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
746224|NCT00521339|Secondary|Time to Relapse of Psoriatic Arthritis During the Observational Follow-up Phase|"A relapse was defined as a 50% loss of maximal American College of Rheumatoid (ACR) Score improvement in participants with psoriatic arthritis who achieved at least an ACR 20 score during the treatment phase.
Relapses were only captured prior to the prescription of concomitant psoriatic treatment."|Observational follow up phase; Days 168 to Day 196|This endpoint was not summarized since there were only 8 participants with psoriatic arthritis enrolled in the study and only 2 participants who achieved an ACR 20 response during the treatment phase.|||||
746225|NCT00521339|Secondary|Percent of Participants With Psoriatic Arthritis Who Achieved an American College of Rheumatology 20% Improvement (ACR-20) Response at Week 12|"A participant was a responder if the following 3 criteria for improvement from baseline were met:
≥ 20% improvement in 78 tender joint count;
≥ 20% improvement in 76 swollen joint count; and
≥ 20% improvement in at least 3 of the 5 following parameters: Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Patient's global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); C-Reactive Protein."|Baseline to Week 12|Safety population consisted of all participants who were enrolled and received at least one dose of study medication. Last observation carried forward was used. Only a small percentage of participants had psoriatic arthritis.||percentage of participants|||Number
746226|NCT00521339|Secondary|Time to Relapse of Psoriasis (50% Loss of Maximal PASI Score Improvement in Participants Who Achieved at Least PASI-50 During the Treatment Phase) During the Observational Follow up Phase|Time to relapse of psoriasis (50% loss of maximal PASI score improvement in participants who achieved at least PASI-50 during the treatment phase) during the observational follow up phase was not analyzed. Time to relapse of psoriasis was defined as a 50% loss of maximal PASI score improvement in participants who achieved at least PASI-50 during the treatment or extension phase. The lesion on each area of the body was assessed for redness, thickness, and scaling.|28-day Observational Follow-up Phase; Days 168 to Day 196.|Time to relapse of psoriasis was not analyzed due to the small number of participants enrolled and who achieved PASI-50 and entered the observation follow-up phase.|||||
746227|NCT00521339|Secondary|Time to Achieve PASI-75 During Treatment Phase|Time to achieve PASI-75 during treatment phase was not analyzed. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. These values for each anatomic region are summed to yield the PASI score.||Time to achieve PASI-75 was not analyzed, due to the small number of participants enrolled and who achieved PASI-75.|||||
746228|NCT00521339|Secondary|Time to Clinically Relevant Response (Time to Achieve PASI-50) During Treatment Phase|Time to clinically relevant response (time to achieve PASI-50) during treatment phase was not analyzed. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head,trunk, upper limbs, and lower limbs. Degree of involvement on each of the4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. These values for each anatomic region are summed to yield the PASI score.||Time to achieve PASI-50 was not analyzed since the study enrolled a small number of participants and the number of participants who achieved PASI-50 was even smaller.|||||
746229|NCT00521339|Secondary|Percent Change From Baseline in the Psoriasis Affected Body Surface Area (BSA) Involvement at Week 12|The BSA estimate was based on the palm area of the hand of the participant which equates to 1% of the total body surface area.|Baseline to Week 12|Safety population consisted of all participants who were enrolled and received at least one dose of study medication.||Percent change in BSA||Standard Deviation|Mean
746230|NCT00521339|Secondary|Maximal PASI Response Documented for Each Participant During Treatment Phase|PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head,trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. These values for each anatomic region are summed to yield the PASI score.|Baseline to Week 12|Maximal PASI response was not analyzed since similar information was captured in change in psoriasis area severity Index (PASI) score at Day 85, which is week 12.|||||
746231|NCT00521339|Secondary|Percentage of Participants Who Achieved a PASI-50 Score at Week 12|PASI -50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score at Week 12. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head,trunk, upper limbs, and lower limbs. Degree of involvement on each of the4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant.|Baseline to Week 12|Safety population consisted of all participants who were enrolled and received at least one dose of study medication. If participant had a missing evaluation for any time point assessments, the last observation carried forward (LOCF) method of imputation was used.||percentage of participants||95% Confidence Interval|Number
746232|NCT00521339|Secondary|Percentage of Participants Who Achieved a PASI-75 Score at Week 12|PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 12. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant.|Baseline to Week 12|Safety population consisted of all participants who were enrolled and received at least one dose of study medication. If participant had a missing evaluation for any time point assessments, the last observation carried forward (LOCF) method of imputation was used.||percentage of participants||95% Confidence Interval|Number
746233|NCT00521339|Secondary|Percent Change From Baseline in Psoriasis Area Severity Index (PASI) Score at Week 12|The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. These values for each anatomic region are summed to yield the PASI score.|Baseline and Week 12|Safety population consisted of all participants who were enrolled and received at least one dose of study medication.||percent change||Standard Deviation|Mean
746234|NCT00521339|Secondary|Percentage of Participants With at Least a 1 Point Reduction on 0 to 5 Point Scale From Baseline in Static Physician Global Assessment (sPGA) at Week 12|The static Physician’s Global Assessment (sPGA) rated the investigator’s overall clinical assessment of a participants plaque thickness, erythema, and scaling on a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (majority of plaques have severe thickness, erythema, and scale). To assign a sPGA score, the investigator examined all psoriatic lesions and assigned a severity score ranging from 0 to 5 for thickness, erythema, and scaling. Scores for thickness, erythema, and scaling are summed and the mean of these 3 scores equals the overall sPGA score. Decreases in sPGA correspond to clinical improvement.|Baseline and Week 12|Safety population consisted of all participants who were enrolled and received at least one dose of study medication. Last Observation Carried Forward.||percentage of participants||95% Confidence Interval|Number
746235|NCT00521339|Primary|Treatment Emergent Adverse Events (TEAEs) During the Treatment Phase|"TEAE = any AE occurring or worsening on or after the first treatment with any study drug. Related = suspected by investigator to be related to study treatment. National Cancer Institute [NCI] Common Toxicity Criteria for Adverse Events [CTCAE], Version 3.0, grades: 1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, 5 = death.
Adverse event (AE) = any noxious, unintended, or untoward medical occurrence occurring at any dose that may appear or worsen in a participant during the course of a study, including new intercurrent illness, worsening concomitant illness, injury, or any concomitant impairment of participant's health, including laboratory test values, regardless of etiology. Serious adverse event (SAE) = any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect; constitutes an important medical event."|Week 0 to Week 12|Safety population consisted of all participants who were enrolled and received at least one dose of study medication.||participants|||Number
746236|NCT00521352|Secondary|Clinical Improvement (CGI-S)|"Minimum CGI-S score: 1 Maximum CGI-S score: 7
Higher scores indicate the presence of high symptom severity. Decrease in scores from baseline reflects clinical symptom improvement.
Patients will be classified as responders with a CGI-S = 1 or 2; and partial responders CGI-S = 3.
= Normal, not at all ill
= Borderline mentally ill
= Mildly ill
= Moderately ill
= Markedly ill
= Severely ill
= Among the most extremely ill patients"|4 weeks|||responders (CGI-S = 1 or 2)|||Number
746237|NCT00521352|Primary|Hamilton Depression Rating Scale (HDRS), 28 Item Version|"The Hamilton Rating Scale for Depression (HRSD) is a multiple item questionnaire used to provide an indication of depression severity. The 28-, rather then 17- or 24-, item version was used to assess subjects in this protocol.
28-item minimum score = 0 28-item maximum score = 84
Higher scores indicate high levels of symptomatology. Reduction in score from baseline indicates clinical symptom improvement."|4 weeks|||responders|||Number
746238|NCT00521352|Primary|Panic Disorder Severity Scale (PDSS)|"The Panic Disorder Severity Scale is a questionnaire developed for measuring the severity of panic disorder symptoms.
The PDSS consists of seven items, each rated on a 5-point scale, which ranges from 0 to 4. The items assess panic frequency, resulting distress, panic-focused anticipatory anxiety, phobic avoidance of situations and of physical sensations, impairment in occupational and social functioning. The overall assessment is made by a total score, which is calculated by summing the scores for all seven items. The total scores range from 0 to 28.
Higher scores indicate high levels of panic symptomatology. Reduction in score from baseline indicates clinical improvement of panic symptoms."|4 weeks|||responders|||Number
746239|NCT00521365|Secondary|Number of Participants With >7% Increase in Weight|Number of participants with >7% increase in weight from baseline to end of study.|Baseline and 3 weeks|Modified Intention to treat patients mITT- (88), for each outcome measure where mITT is evaluated, population is the group of patients who had taken at least one dose of study drug and had at least one evaluable Young Mania Rating Scale at baseline.||Participants|||Number
746240|NCT00521365|Secondary|Change in Waist Circumference From Baseline to Final Visit or Last Observation Carried Forward (LOCF).||Baseline and 3 weeks|Modified Intention to treat patients mITT- (88), for each outcome measure where mITT is evaluated, population is the group of patients who had taken at least one dose of study drug and had at least one evaluable Young Mania Rating Scale at baseline.||cm||Standard Deviation|Mean
746241|NCT00521365|Secondary|Change in Weight From Baseline to Final Visit or Last Observation Carried Forward (LOCF).||Baseline and 3 weeks|Modified Intention to treat patients mITT- (88), for each outcome measure where mITT is evaluated, population is the group of patients who had taken at least one dose of study drug and had at least one evaluable Young Mania Rating Scale at baseline.||Kg||Standard Deviation|Mean
746242|NCT00521365|Secondary|Change in the Barnes Akathisia Rating Scale (BARS) Total Score From Baseline to Final Visit or Last Observation Carried Forward (LOCF).|Change in the BARS total score from baseline to Final Visit or Last Observation Carried Forward (LOCF). BARS Questionnaire has 4 items with scale range 0 to 3 for 3 items and 0 to 5 for 1 item. 0=Normal; 3 or 5=Most abnormal. Total possible score is 0-14.|Baseline and 3 weeks|Modified Intention to treat patients mITT- (88), for each outcome measure where mITT is evaluated, population is the group of patients who had taken at least one dose of study drug and had at least one evaluable Young Mania Rating Scale at baseline.||Scores on a scale||Standard Deviation|Mean
746243|NCT00521365|Secondary|Change in the Simpson-Angus Scale (SAS) Total Score From Baseline to Final Visit or Last Observation Carried Forward (LOCF).|"Change in the Simpson-Angus Scale (SAS) total score from baseline to Final Visit or Last Observation Carried Forward (LOCF).
SAS Questionnaire has a 6 items with scale range 0 to 3 for each item.0=Normal; 3=Most abnormal. Total possible score is 0-18."|Baseline and 3 weeks|Modified Intention to treat patients mITT- (88), for each outcome measure where mITT is evaluated, population is the group of patients who had taken at least one dose of study drug and had at least one evaluable Young Mania Rating Scale at baseline.||Scores on a scale||Standard Deviation|Mean
746244|NCT00521365|Secondary|Change in the Quality of Life Questionnaire EQ5D Visual Analogue Scale (VAS) From Baseline to Final Visit or Last Observation Carried Forward (LOCF).|Change from baseline to Final Visit or Last Observation Carried Forward (LOCF). Quality of Life Questionnaire (EQ5D) part 2 has 1 item with continuous scale range 0 to 100. 0=The worsen Quality of Life; 100=The best Quality of life.|Baseline and 3 weeks|Modified Intention to treat patients mITT- (88), for each outcome measure where mITT is evaluated, population is the group of patients who had taken at least one dose of study drug and had at least one evaluable Young Mania Rating Scale at baseline.||Scores on a scale||Standard Deviation|Mean
746245|NCT00521365|Secondary|Change in the Quality of Life Questionnaire EQ5D Index From Baseline to End of the Study.|Total possible index score is 0-1(0=The worsen quality of life; 1=The best Quality of life).|Baseline and 3 weeks|Modified Intention to treat patients mITT- (88), for each outcome measure where mITT is evaluated, population is the group of patients who had taken at least one dose of study drug and had at least one evaluable Young Mania Rating Scale at baseline.||Scores on a scale||Standard Deviation|Mean
746246|NCT00521365|Secondary|Change in the Clinical Global Impression - Improvement (CGI-I) at Final Visit or Last Observation Carried Forward (LOCF).|Change in the CGI- I at Final Visit or Last Observation Carried Forward (LOCF). CGI I Questionnaire has a one item with scale range 0 to 7. 0=patients who ere not assessed, 1=Very much improved; 4= No change; 7=Very much worse.|Baseline and 3 weeks|Modified Intention to treat patients mITT- (88), for each outcome measure where mITT is evaluated, population is the group of patients who had taken at least one dose of study drug and had at least one evaluable Young Mania Rating Scale at baseline.||Scores on a scale||Standard Deviation|Mean
746247|NCT00521365|Secondary|Change in the Clinical Global Impression (CGI) Total Score From Baseline (CGI-S) to Final Visit or Last Observation Carried Forward (LOCF)(CGI-I).|Clinical Global Impression-Severity(CGI-S)is a measurement of illness severity evaluated at baseline. Clinical Global Impression-Improvement(CGI-I)is a measurement of improvement taken at Final Visit (FV) or Last Observation Carried Forward(LOCF).Change CGI Total score is assessed with next equation: CGI-I total score at FV or LOCF - CGI-S score. CGI-S Questionnaire has a scale range 0-7. 0=patients who are not assessed, 1=Normal 7=the most extremely ill patients. CGI-I Questionnaire has a scale range 0-7. 0=patients who are not assessed, 1=Very much improved; 4= No change; 7=Very much worse.|Baseline and 3 weeks|Modified Intention to treat patients mITT- (88), for each outcome measure where mITT is evaluated, population is the group of patients who had taken at least one dose of study drug and had at least one evaluable Young Mania Rating Scale at baseline.||Scores on a scale||Standard Deviation|Mean
746248|NCT00521365|Secondary|Number of Participants With Young Mania Rating Scale (YMRS) Remission at Final Visit or Last Observation Carried Forward (LOCF).|"Number of participants that had Young Mania Rating Scale (YMRS) remission at Final Visit or Last Observation Carried Forward (LOCF). A patient is classified in remission if his/her final YMRS total score was ≤11.
YMRS questionnaire has 11 items with scale range 0 to 4 for 7 items and 0 to 8 for 4 items. 0=normal; 4 or 8=most abnormal. Total possible score is 0 - 60."|21 days ± 2 days or Last Observation Carried Forward|||Participants|||Number
746249|NCT00521365|Secondary|Number of Participants With Young Mania Rating Scale (YMRS) Response at Final Visit or Last Observation Carried Forward (LOCF)|"Number of participants that had Young Mania Rating Scale (YMRS) response at Final Visit or Last Observation Carried Forward (LOCF). A patient is scored as responder if the change from inclusion shows a reduction of 6 points in the YMRS total score.
YMRS questionnaire has 11 items with scale range 0 to 4 for 7 items and 0 to 8 for 4 items. 0=normal; 4 or 8=most abnormal. Total possible score is 0 - 60."|21 days ± 2 days or Last Observation Carried Forward|||Participants|||Number
746250|NCT00521365|Secondary|Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Visit 3|Change in the YMRS total score from baseline to visit 3(2 weeks). YMRS questionnaire has 11 items with scale range 0 to 4 for 7 items and 0 to 8 for 4 items. 0=normal; 4 or 8=most abnormal. Total possible score is 0-60.|Baseline and 2 weeks|Outcome was comparing the data at baseline with the specific data at visit 3 (not with the LOCF), since only 79 patients completed YMRS at visit 3 the number of patients analyzed is different respect to the LOCF (88).||Scores on a scale||Standard Deviation|Mean
746251|NCT00521365|Secondary|Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Visit 2.|Change in the YMRS total score from baseline to visit 2 (1 week) ,. YMRS questionnaire has 11 items with scale range 0 to 4 for 7 items and 0 to 8 for 4 items. 0=normal; 4 or 8=most abnormal. Total possible score is 0-60.|Baseline and 1 week|Outcome was comparing the data at baseline with the specific data at visit 2(not with the LOCF), since only 78 patients completed YMRS at visit 2 the number of patients analyzed is different respect to the LOCF (88).||Scores on a scale||Standard Deviation|Mean
746252|NCT00521365|Primary|Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to End of Treatment (Day 21)|Change in the YMRS total score from baseline to Final Visit or Last Observation Carried Forward (LOCF), modified intention to treat (mITT) population. YMRS questionnaire has 11 items with scale range 0 to 4 for 7 items and 0 to 8 for 4 items. 0=normal; 4 or 8=most abnormal. Total possible score is 0 - 60.|Baseline and 3 weeks|Modified Intention to treat patients (88). Patients who had taken at least one dose of study drug and had at least one evaluable Young Mania Rating Scale at baseline.||Scores on a scale||Standard Deviation|Mean
746253|NCT00521456|Post-Hoc|Visual Acuity|Patients with ≥ 3 line improvement in visual acuity|Change from baseline at Day 14|Modified Intent-to-Treat Population||Percentage of patients with ≥ 3 lines|||Number
746254|NCT00521456|Secondary|Mean Pupil Area|Pupil area post-irrigation and aspiration|Day 0|Modified Intent-to-Treat Population||millimeters squared (mm²)||Standard Deviation|Mean
746255|NCT00521456|Secondary|Ocular Pain|Measured on a scale of 0-4 (0 = none, 4 = intolerable)|Day 1|Modified Intent-to-Treat Population||% of participants with a score of 0|||Number
746256|NCT00521456|Primary|Resolution of Post Operative Inflammation|Anterior chamber inflammation is the sum of biomicroscopic cell and flare; each measured on a scale of 0-4 (Flare: 0 = no flare, 4 = intense flare / Cell: 0 = no cells, 4 = >50 cells)|Day 14|Modified Intent-to-Treat Population||% of participants with a score of 0|||Number
746257|NCT00521586|Other Pre-specified|Percentage of Participants With Serious Adverse Events (SAEs) or Non-serious Adverse Events (Non-SAEs)|AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Non-serious AEs are AEs excluding SAEs. In Years 1-4, only deaths and withdrawals due to AEs or SAEs were to be recorded in the case report form.|Signing of informed consent up to 194 days after re-vaccination at Year 5|Safety population included all participants who had received at least 1 vaccination and did not lack any safety data. Here, n=number of participants with known values.||percentage of participants|||Number
746258|NCT00521586|Other Pre-specified|Percentage of Participants Reporting Pre-specified Acute Pain Within 30 Minutes After 13vPnC (Year 5)|Acute pain was not prompted in the electronic diary however were recorded in a specific page of the case report form (CRF). Acute pain at injection site pain occurred within 30 minutes of vaccination and was scaled as: Any (pain present); Mild (easily tolerated); Moderate (discomfort interfering the usual activity); Severe (Incapacitating with inability to do usual activity).|Within 30 Minutes After 13vPnC (Year 5)|Safety population at Year 5 included all participants who had received at least 1 vaccination and did not lack any safety data.||percentage of participants|||Number
746259|NCT00521586|Other Pre-specified|Percentage of Participants Reporting Pre-specified Acute Pain Within 30 Minutes After Dose 2 (Year 0)|Acute pain was not prompted in the electronic diary however were recorded in a specific page of the case report form (CRF). Acute pain at injection site pain occurred within 30 minutes of vaccination and was scaled as: Any (pain present); Mild (easily tolerated); Moderate (discomfort interfering the usual activity); Severe (Incapacitating with inability to do usual activity). Acute pain was measured only on the participant's arm vaccinated with either 13vPnC or placebo and were not collected at the TIV injection site.|Within 30 Minutes After Dose 2 (Year 0)|Safety population included all participants who had received at least 1 vaccination (Dose 2, year 0) and did not lack any safety data.||percentage of participants|||Number
746260|NCT00521586|Other Pre-specified|Percentage of Participants Reporting Pre-specified Acute Pain Within 30 Minutes After Dose 1 (Year 0)|Acute pain was not prompted in the electronic diary however were recorded in a specific page of the case report form (CRF). Acute pain at injection site pain occurred within 30 minutes of vaccination and was scaled as: Any (pain present); Mild (easily tolerated); Moderate (discomfort interfering the usual activity); Severe (Incapacitating with inability to do usual activity). Acute pain was measured only on the participant’s arm vaccinated with either 13vPnC or placebo and were not collected at the TIV injection site.|Within 30 Minutes After Dose 1 (Year 0)|Safety population included all participants who had received at least 1 vaccination and did not lack any safety data.||percentage of participants|||Number
747182|NCT00528021|Primary|Clinical Cure|No live lice 14 days following last treatment|Day 15 or 22|||participant|||Number
746261|NCT00521586|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After 13vPnC (Year 5)|Percentage of participants who experienced specific systemic events (Fever: >= 38.0 degrees Celsius [C], mild: 38.0 to 38.4 degrees C, moderate: 38.5 to 38.9 degrees C, severe: 39.0 to 40.0 degrees C and potentially life threatening > 40.0 degrees C), chills, fatigue, headache, vomiting, decreased appetite, rash, new generalized muscle pain, aggravated generalized muscle pain, new generalized joint pain, and aggravated generalized joint pain prompted for each day were reported using an electronic diary.|Within 14 days after 13vPnC (Year 5)|The safety population at Year 5 included participants who received both (Year 0 and Year 5) 13vPnC and had some safety results at Year 5. Here, n=number of participants with known values.||percentage of participants|||Number
746262|NCT00521586|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Dose 2 (Year 0)|Percentage of participants who experienced specific systemic events (absent: 38.0 degrees Celsius [C], mild: 38.0 to 38.4 degrees C, moderate: 38.5 to 38.9 degrees C, severe: 39.0 to 40.0 degrees C and potentially life threatening > 40.0 degrees C), chills, fatigue, headache, vomiting, decreased appetite, rash, new generalized muscle pain, aggravated generalized muscle pain, new generalized joint pain, and aggravated generalized joint pain prompted for each day were reported using an electronic diary.|Within 14 days after Dose 2 (Year 0)|Safety population included all participants who had received at least 1 vaccination and did not lack any safety data. Here, n=number of participants with known values.||percentage of participants|||Number
746263|NCT00521586|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Dose 1 (Year 0)|Percentage of participants who experienced specific systemic events (mild: 38.0 to 38.4 degrees Celsius [C], moderate: 38.5 to 38.9 degrees C, severe: 39.0 to 40.0 degrees C and potentially life threatening greater than [>] 40.0 degrees C), chills, fatigue, headache, vomiting, decreased appetite, rash, new generalized muscle pain, aggravated generalized muscle pain, new generalized joint pain, and aggravated generalized joint pain prompted for each day were reported using an electronic diary.|Within 14 days after Dose 1 (Year 0)|Safety population included all participants who had received at least 1 vaccination and did not lack any safety data. Here, n=number of participants with known values.||percentage of participants|||Number
746264|NCT00521586|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After 13vPnC (Year 5)|Specific local reactions were prompted for each day,and reported using an electronic diary.Redness and Swelling were scaled as Any(redness present or swelling present);Mild(2.5 to 5.0 centimeters [cm]);Moderate(5.1 to 10.0 cm);Severe (>10 cm). Pain at injection site was scaled as: Any (pain present); Mild (awareness of sign or symptom, but easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, with inability to do usual activity). Limitation of arm movement was scaled as Any(no limitation of arm movement);Mild(some limitation of arm movement);Moderate (unable to move arm above head but able to move arm above shoulder);Severe (unable to move arm above shoulder).|Within 14 days after 13vPnC (Year 5)|The safety population at Year 5 included participants who received both (Year 0 and Year 5) 13vPnC and had some safety results at Year 5. Here, n=number of participants with known values.||percentage of participants|||Number
746265|NCT00521586|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Dose 2 (Year 0)|Specific local reactions were prompted for each day,and reported using an electronic diary.Redness and Swelling were scaled as Any(redness present or swelling present);Mild(2.5 to 5.0 centimeters [cm]);Moderate(5.1 to 10.0 cm);Severe (>10 cm). Pain at injection site was scaled as: Any (pain present); Mild (awareness of sign or symptom, but easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, with inability to do usual activity). Limitation of arm movement was scaled as Any(no limitation of arm movement);Mild(some limitation of arm movement);Moderate (unable to move arm above head but able to move arm above shoulder);Severe (unable to move arm above shoulder). Local reactions were measured only on the participant’s arm vaccinated with either 13vPnC or placebo and were not collected at the TIV injection site.|Within 14 days after Dose 2 (Year 0)|Safety population included all participants who had received at least 1 vaccination and did not lack any safety data. Here,n=number of participants with known values.||percentage of participants|||Number
746266|NCT00521586|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Dose 1 (Year 0)|Specific local reactions were prompted for each day,and reported using an electronic diary.Redness and Swelling were scaled as Any(redness present or swelling present);Mild(2.5 to 5.0 centimeters [cm]);Moderate(5.1 to 10.0 cm);Severe (>10 cm). Pain at injection site was scaled as: Any (pain present); Mild (awareness of sign or symptom, but easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, with inability to do usual activity). Limitation of arm movement was scaled as Any(no limitation of arm movement);Mild(some limitation of arm movement);Moderate (unable to move arm above head but able to move arm above shoulder);Severe (unable to move arm above shoulder). Local reactions were measured only on the participant’s arm vaccinated with either 13vPnC or placebo and were not collected at the TIV injection site.|Within 14 days after Dose 1 (Year 0)|Safety population included all participants who had received at least 1 vaccination and did not lack any safety data. Here, n=number of participants with known values.||percentage of participants|||Number
746267|NCT00521586|Other Pre-specified|Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) 1 Month After 13vPnC (Year 0),1, 2, 3, 4 Years After Initial Vaccination (Year 0); Before and 1 Month After 13vPnC (Year 5) Relative to Before 13vPnC (Year 0)|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined from before to 1 month after 13vPnC (Year 0), at years 1, 2, 3 and 4 after initial vaccination (Year 0), before, 1 month after 13vPnC (Year 5) and were summarized geometric means and 2-sided 95% CIs, which were computed using the logarithmically transformed assay results. CI for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rises. GMFRs were calculated using all participants with available data from both the baseline and the various time points.|Before, 1 month after 13vPnC (Year 0), at years 1, 2, 3 and 4 after initial vaccination (Year 0), before, 1 month after 13vPnC (Year 5)|Subset of all-available immunogenicity population with data at Years 0 through 5 included participants with immunogenicity data at all-time points from Year 0 through Year 5 within the protocol specified time window. n=participants with valid and determinate assay results for both the before 13vPnC (Year 0) and the specified timepoints.||fold-rises||95% Confidence Interval|Geometric Mean
746268|NCT00521586|Other Pre-specified|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC (Year 0), 1, 2, 3, 4 Years After Initial Vaccination (Year 0); Before and 1 Month After 13vPnC (Year 5)|Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1(Dose1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1(Dose 1, placebo+TIV). Placebo matched to 13vPnC was administered 1 month after(Dose 2, placebo), or 13vPnC was administered 1 month after (Dose 2, 13vPnC).Participants were further followed-up for 1 month,then attended a 6-month follow-up visit for safety.Participants were then followed-up yearly for 4 years.Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination.Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.|Before,1 month after 13vPnC (Year 0), 1, 2, 3, 4 years after initial vaccination (Year 0); before,1 month after 13vPnC (Year 5)|Subset of all-available immunogenicity population with data at Years 0 through 5 included participants with immunogenicity data at all-time points from Years 0 through Year 5 within the protocol specified time window. Here, n=number of participants with valid and determinate assay results for the specified serotype at the given time points.||mcg/mL||95% Confidence Interval|Geometric Mean
746269|NCT00521586|Other Pre-specified|Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) 1 Month After 13vPnC Re-vaccinated Dose (Year 5) Relative to Before 13vPnC (Year 0)|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined from Before 13vPnC (Year 0) to 1 month after 13vPnC re-vaccinated dose (Year 5) and were summarized geometric means and 2-sided 95% CIs, which were computed using the logarithmically transformed assay results. CI for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rises. GMFRs were calculated using all participants with available data from both before 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.|Before 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)|All-available immunogenicity population at Years 0 and 5. n=participants with valid and determinate assay results for the specified serotype for both before 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.||fold-rises||95% Confidence Interval|Geometric Mean
746270|NCT00521586|Other Pre-specified|Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs) Before 13vPnC (Year 0) and 1 Month After 13vPnC Re-vaccinated Dose (Year 5)|Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for adult participants are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data before 13vPnC (Year 0) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draw. CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Participants in this population must have immunogenicity data at both the Year 0 and Year 5 time points.|before 13vPnC (Year 0) and 1 month after 13vPnC re-vaccinated dose (Year 5)|All-available immunogenicity population at Years 0 and 5. n=participants with valid and determinate assay results for the specified serotype for both before 13vPnC (Year 0) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.||mcg/mL||95% Confidence Interval|Geometric Mean
746271|NCT00521586|Other Pre-specified|Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) 1 Month After 13vPnC Re-vaccinated Dose (Year 5) Relative to 1 Month After 13vPnC (Year 0)|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined from 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) and were summarized geometric means and 2-sided 95% CIs, which were computed using the logarithmically transformed assay results. CI for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rises. GMFRs were calculated using all participants with available data from both 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.|1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)|All-available immunogenicity population at Years 0 and 5. n=participants with valid and determinate assay results for the specified serotype for both 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.||fold-rises||95% Confidence Interval|Geometric Mean
746272|NCT00521586|Other Pre-specified|Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs) 1 Month After 13vPnC (Year 0) and 1 Month After 13vPnC Re-vaccinated Dose (Year 5)|Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for adult participants are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) blood draw. CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Participants in this population must have immunogenicity data at both the Year 0 and Year 5 time points|1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)|All-available immunogenicity population at Years 0 and 5. n=participants with valid and determinate assay results for the specified serotype for both 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.||mcg/mL||95% Confidence Interval|Geometric Mean
746273|NCT00521586|Other Pre-specified|Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) 1 Month After 13vPnC Re-vaccinated Dose (Year 5) Relative to Before 13vPnC (Year 5)|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined from before 13vPnC (Year 5) to 1 month after 13vPnC re-vaccinated dose (Year 5) and were summarized geometric means and 2-sided 95% CIs, which were computed using the logarithmically transformed assay results. CI for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rises. GMFRs were calculated using all participants with available data from both before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.|before 13vPnC (Year 5), 1 month after 13vPnC re-vaccinated dose (Year 5)|All-available immunogenicity population at Year 5. n=participants with valid and determinate assay results for the specified serotype for both before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.||fold-rises||95% Confidence Interval|Geometric Mean
747183|NCT00521053|Secondary|Overall Survival|1-year survival|52 weeks|ITT participants||percentage of participants|||Number
746274|NCT00521586|Other Pre-specified|Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs) Before 13vPnC (Year 5) and 1 Month After 13vPnC Re-vaccinated Dose (Year 5)|Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for adult participants are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draw. CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Participants in this population must have immunogenicity data at both Year 5 time points.|before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5)|All-available immunogenicity population at Year 5. n=participants with valid and determinate assay results for the specified serotype at before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.||mcg/mL||95% Confidence Interval|Geometric Mean
746275|NCT00521586|Other Pre-specified|Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs) 1 Month After 13vPnC (Year 5)|Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for adult participants are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated. Geometric means were calculated using all participants with available data for 1 month after 13vPnC Dose 1 blood draw. CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|1 month after 13vPnC (Year 5)|All-available immunogenicity population at Year 5. n=participants with valid and determinate assay results for the specified serotype at 1 month after 13vPnC (Year 5) blood draws for each treatment arm, respectively.||microgram per milliliter(mcg/mL)||95% Confidence Interval|Geometric Mean
746276|NCT00521586|Other Pre-specified|Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) 1 Month After 13vPnC (Year 0),1, 2, 3, 4 Years After Initial Vaccination (Year 0); Before and 1 Month After 13vPnC (Year 5) Relative to Before 13vPnC (Year 0)|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined from before to 1 month after 13vPnC (Year 0), at years 1, 2, 3 and 4 after initial vaccination (Year 0), before, 1 month after 13vPnC (Year 5) and were summarized geometric means and 2-sided 95% CIs, which were computed using the logarithmically transformed assay results. CI for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rises. GMFRs were calculated using all participants with available data from both the baseline and the various time points.|Before, 1 month after 13vPnC (Year 0), at years 1, 2, 3 and 4 after initial vaccination (Year 0), before, 1 month after 13vPnC (Year 5)|Subset of all-available immunogenicity population with data at Years 0 through 5 included participants with immunogenicity data at all-time points from Year 0 through Year 5 within the protocol specified time window. n=participants with valid and determinate assay results for both the before 13vPnC (Year 0) and all the specified timepoints.||fold-rises||95% Confidence Interval|Geometric Mean
746277|NCT00521586|Other Pre-specified|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC (Year 0), 1, 2, 3, 4 Years After Initial Vaccination (Year 0); Before and 1 Month After 13vPnC (Year 5)|Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of participants using a microcolony OPA (mcOPA) assay. GMT (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data before, 1 month after 13vPnC (Year 0), at Years 1, 2, 3 and 4 after initial vaccination (Year 0), before, 1 month after 13vPnC (Year 5) blood draws. CI for GMT were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers. n=participants with valid and determinate assay results for the specified serotype at before, 1 month after 13vPnC (Year 0), at Years 1, 2, 3 and 4 after initial vaccination (Year 0), before, 1 month after 13vPnC (Year 5) blood draws.|Before,1 month after 13vPnC (Year 0), 1, 2, 3, 4 years after initial vaccination (Year 0); before,1 month after 13vPnC (Year 5)|Subset of all-available immunogenicity population with data at Years 0 through 5 included participants with immunogenicity data at all-time points from Year 0 through Year 5 within the protocol specified time window.||titers||95% Confidence Interval|Geometric Mean
746278|NCT00521586|Other Pre-specified|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) 1 Month After 13vPnC Re-vaccinated Dose (Year 5) Relative to Before 13vPnC (Year 0)|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined from before13vPnC (Year 0) to 1 month after 13vPnC re-vaccinated dose (Year 5) and were summarized geometric means and 2-sided 95% CIs, which were computed using the logarithmically transformed assay results. CI for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rises. GMFRs were calculated using all participants with available data from both before 13vPnC (Year 0) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.|before 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)|All-available immunogenicity population at Years 0 and 5. n=participants with valid and determinate assay results for the specified serotype from both before 13vPnC (Year 0) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.||fold-rises||95% Confidence Interval|Geometric Mean
746279|NCT00521586|Other Pre-specified|Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) Before 13vPnC (Year 0) and 1 Month After 13vPnC Re-vaccinated Dose (Year 5)|Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of participants using a microcolony OPA (mcOPA) assay. GMTs (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for before 13vPnC (Year 0) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws. CI for GMTs were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers. Participants in this population must have immunogenicity data at both the Year 0 and Year 5 time points.|before 13vPnC (Year 0) and 1 month after 13vPnC re-vaccinated dose (Year 5)|All-available immunogenicity population at Years 0 and 5. n=participants with valid and determinate assay results for the specified serotype for both before 13vPnC (Year 0) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.||titers||95% Confidence Interval|Geometric Mean
746427|NCT00523341|Primary|Number of Participants With Laboratory Toxicities of Grade ≥ 3|Laboratory toxicity grading was based on Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Grade 3 indicates severe toxicity and Grade 4 indicates life-threatening toxicity.|84 months|All participants who received at least 1 dose of denosumab||participants|||Number
746280|NCT00521586|Other Pre-specified|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) 1 Month After 13vPnC Re-vaccinated Dose (Year 5) Relative to 1 Month After 13vPnC (Year 0)|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined from 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) and were summarized geometric means and 2-sided 95% CIs, which were computed using the logarithmically transformed assay results. CI for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rises. GMFRs were calculated using all participants with available data from both 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.|1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)|All-available immunogenicity population at Years 0 and 5. n=participants with valid and determinate assay results for the specified serotype from both 1 month after 13vPnC (Year 0) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.||fold-rises||95% Confidence Interval|Geometric Mean
746281|NCT00521586|Other Pre-specified|Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After 13vPnC (Year 0) and 1 Month After 13vPnC Re-vaccinated Dose (Year 5)|Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of participants using a microcolony OPA (mcOPA) assay. GMTs (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) blood draws. CI for GMTs were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers. Participants in this population must have immunogenicity data at both the Year 0 and Year 5 time points.n=participants with valid and determinate assay results for the specified serotype for both 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.|1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)|All-available immunogenicity population at Year 0 and 5 included participants who had at least 1 valid and determinate assay result related to the proposed analysis.||titers||95% Confidence Interval|Geometric Mean
746282|NCT00521586|Other Pre-specified|Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold-Rises (GMFRs) 1 Month After 13vPnC Re-vaccinated Dose (Year 5) Relative to Before 13vPnC (Year 5)|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined from before 13vPnC (Year 5) to 1 month after 13vPnC re-vaccinated dose (Year 5) and were summarized geometric means and 2-sided 95% CIs, which were computed using the logarithmically transformed assay results. CI for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rises. GMFRs were calculated using all participants with available data from both before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws. n=participants with valid and determinate assay results for the specified serotype from both before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.|before 13vPnC (Year 5), 1 month after 13vPnC re-vaccinated dose (Year 5)|All-available immunogenicity population at Year 5 included participants who had at least 1 valid and determinate assay result related to the proposed analysis.||fold-rises||95% Confidence Interval|Geometric Mean
746283|NCT00521586|Other Pre-specified|Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) Before 13vPnC (Year 5) and 1 Month After 13vPnC Re-vaccinated Dose (Year 5)|Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of participants using a microcolony OPA (mcOPA) assay. GMTs (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws. CI for GMTs were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers. Participants with immunogenicity data at both Year 5 endpoints.|before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5)|All-available immunogenicity population at Year 5.n=participants with valid and determinate assay results for the specified serotype at before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws for each treatment arm, respectively.||titers||95% Confidence Interval|Geometric Mean
746284|NCT00521586|Other Pre-specified|Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC (Year 5)|Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of participants using a microcolony OPA (mcOPA) assay. GMTs (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for 1 Month After 13vPnC (Year 5) blood draws. CI for GMTs were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|1 month after 13vPnC (Year 5)|All-available immunogenicity population at Year 5 included participants who had at least 1 valid and determinate assay result related to the proposed analysis. n=participants with valid and determinate assay results for the specified serotype at 1 month after 13vPnC (Year 5) blood draws for each treatment arm, respectively.||titers||95% Confidence Interval|Geometric Mean
746285|NCT00521586|Primary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose|Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for adult participants are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated. Geometric means were calculated using all participants with available data for 1 month after 13vPnC Dose at year 0 blood draw. CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|1 month after 13vPnC Dose at year 0|Evaluable immunogenicity population:eligible participants who received vaccination as assigned;had blood drawn within pre-specified time-frames;had at least 1 valid,determinate assay result;had no major protocol violation. n=participants with valid and determinate assay results for the specified serotype at the given visit.||microgram per milliliter (mcg/mL)||95% Confidence Interval|Geometric Mean
746337|NCT00522418|Secondary|Treatment Emergent Adverse Events, Device Complications, and Premature Study Withdrawal|Number of participants with treatment emergent adverse events, device complications, and premature Study withdrawal.|At 12 and 24 months|This study was conducted between February 2006 and July 2008 and was prematurely terminated by Cyberonics, Inc. due to a low enrollment rate and not as a result of a safety or efficacy signal. Because of early termination and limited data this outcome measure was not tabulated.|||||
746286|NCT00521586|Primary|Percentage of Participants Achieving at Least 4-fold Increase in Titer for Concomitant Trivalent Inactivated Influenza Vaccine (TIV) Antigens 1 Month After Dose 1|Percentage of participants achieving at least 4-fold increase in titer for concomitant Trivalent Inactivated Influenza Vaccine (TIV) were measured by standard Hemagglutination Inhibition Assay (HAI) for the A/H1, A/H3, and B vaccine strains.Exact, unconditional, 2-sided, 95% confidence intervals (CI) on the difference in proportions (13vPnC+TIV – Placebo+TIV) was calculated. N(number of participants analyzed)=participants with a determinate antibody titer to the given concomitant vaccine antigen. n=participants who met the prespecified level for the given antigen.|1 month after Dose 1|Evaluable immunogenicity population:eligible participants who received vaccination as assigned;had blood drawn within pre-specified time-frames;had at least 1 valid,determinate assay result;had no major protocol violation.||percentage of participants||95% Confidence Interval|Number
746287|NCT00521599|Primary|Change From Baseline in the Average AM Peak Expiratory Flow (PEF) Over the 7 Days of Week 8.|Week 8 End = The last 7 days of data with the last day within the range of Days 51 to 64.|Baseline and Week 8 End|All treated subjects included all but one placebo-treated subject from the All Randomized Subjects data set, who was randomized, but never treated in either the open-label or double-blind Treatment Periods due to non-compliance with the protocol||liters/minute||Standard Deviation|Least Squares Mean
746288|NCT00521924|Secondary|DAS 28 at Baseline vs at Week 38; Quality of Life; American College of Rheumatology (ACR) Response Disease Progression (X-ray); Effect of Inflammatory Markers on Response and Disease Progression; Assess Simplified Disease Activity Index (SDAI).|These were not prespecified key secondary outcomes; therefore, results will not be disclosed.|Weeks 14, 38, and 62||||||
746289|NCT00521924|Primary|Number of Patients in Remission According to Disease Activity Score (DAS) 28 (< 2.6)|The DAS 28 is an assessment of disease activity based on swollen joint count, erythrocyte sedimentation rate, and general health. Patients can be scored on a range of 0 to 10, with lower scores indicating less disease activity.|after 38 weeks|This trial terminated early due to poor enrollment. Since none of the randomized patients reached Week 38, no change of DAS28 between baseline and Week 38 could be analyzed.|||||
746290|NCT00521976|Secondary|Recurrent Troponin-T (TnT) Positive Events|Recurrent Troponin-T (TnT) positive events; Symptoms of coronary ischemia associated with TnT >0.05 ng/mL with a pattern of gradual rise and fall in TnT|24 months.|||Participants|||Number
746291|NCT00521976|Primary|Total Mortality.||24 months.|||Participants.|||Number
746292|NCT00521989|Secondary|To Assess the Efficacy of the CRx-102 Compared to Placebo on the Change From Baseline to Day 98 Using the Full WOMAC Pain, Stiffness, Physical Function Parameters, and Patient Global Assessment VAS.||Day 98||||||
746293|NCT00521989|Primary|Change From Baseline to Day 98 Using the WOMAC Pain Question #1|"The WOMAC Index is a validated, 24-question self-administered assessment of three dimensions of pain, stiffness, and physical function for subjects with knee or hip OA. The WOMAC pain question #1 asks subjects to think about the pain you felt in your (study joint) caused by your arthritis during the last 48 hours when walking on a flat surface. This is a visual analog scale (VAS) where the subject indicates pain severity by making a mark through a 100 mm horizontal line with No Pain on the left (0 mm) and Extreme Pain on the right (100 mm). The distance between the left end of the scale and the subject's mark is measured in millimeters. Lower values represent a better outcome."|Baseline to Day 98|ITT population||millimeters||Standard Deviation|Mean
746294|NCT00522041|Secondary|Percentage of Responders|Participants rated the pain associated with their chronic anal fissure over the preceding 24 hours on a 100 mm visual analog scale at Baseline and on Days 14 through 18. The average pain rating on Days 14 through 18 was calculated. The left-end of the visual analog scale was labelled “least possible pain” and the right-end of the visual analog scale was labelled “worst possible pain”. The pain rating ranged from 0 to 100, with a higher score indicating more pain. A responder was defined as a participant with either a ≥ 50% decrease or a ≥ 10 mm decrease from Baseline in the 24 hour average pain intensity averaged over Days 14 to 18.|Baseline to Day 18|Intent-to-treat population: All randomized participants who had applied the study medication at least once.||Percentage of responders|||Number
746295|NCT00522041|Secondary|Time to an Improvement in Pain Intensity|Participants rated the pain associated with their chronic anal fissure over the preceding 24 hours on a 100 mm visual analog scale (VAS) at Baseline and on each of the 21 treatment days of the study. The left-end of the visual analog scale was labelled “least possible pain” and the right-end of the visual analog scale was labelled “worst possible pain”. The pain rating ranged from 0 to 100, with a higher score indicating more pain. Improvement was defined as either a ≥ 50% decrease or a ≥ 10 mm decrease from Baseline in rated pain intensity.|Baseline to Day 21|Intent-to-treat population: All randomized participants who had applied the study medication at least once. Only participants with an improvement in pain intensity were included in the analysis.||Days||Standard Error|Mean
746296|NCT00522041|Primary|Change From Baseline in Pain Intensity at Days 14-18|Participants rated the pain associated with their chronic anal fissure over the preceding 24 hours on a 100 mm visual analog scale at Baseline and on Days 14 through 18. The average pain rating on Days 14 through 18 was calculated and used to determine the change from Baseline. The left-end of the visual analog scale was labelled “least possible pain” and the right-end of the visual analog scale was labelled “worst possible pain”. The pain rating ranged from 0 to 100, with a higher score indicating more pain. A negative change score indicated improvement.|Baseline to Day 18|Intent-to-treat population: All randomized participants who had applied the study medication at least once.||Units on a scale||Standard Error|Mean
746297|NCT00522171|Secondary|Total Number of Hours From Drain Placement to Drain Removal|Total number of hours from drain placement to drain removal|From drain placement to drain removal (</= 770 hours)|terminated study||hours||Standard Deviation|Mean
746298|NCT00522171|Primary|Total Volume (mL) From the Time of Drain Placement to Time of Drain Removal|Postoperative serous drainage volume was measured in milliliters and defined as the volume of serous fluid collected from the wound drains installed after the study procedure|From the time of drain placement to time of drain removal (</= 770 hours)|ITT||milliliter||Standard Deviation|Mean
746338|NCT00522418|Secondary|Retention Rate|Percent of participants who were compliant with the protocol.|At 12 and 24 months|This study was conducted between February 2006 and July 2008 and was prematurely terminated by Cyberonics, Inc. due to a low enrollment rate and not as a result of a safety or efficacy signal. Because of early termination and limited data this outcome measure was not tabulated.|||||
746299|NCT00522275|Secondary|Percentage of at Least 50 % Responders During the Treatment Period (Maximum 6 Years)|At least 50 percent response is based on the percentage reduction in 28-day seizure frequency during the Treatment Period of the open-label extension relative to the Baseline Phase of the prior study.|Treatment Period (Maximum 6 years)|Of the 308 subjects who were enrolled/treated in the study, 307 are included in this summary based on the Full Analysis Set (FAS). FAS population: number of subjects treated with at least 1 post-baseline seizure diary day with available data during the SP756 study.||percentage of subjects|||Number
746300|NCT00522275|Secondary|Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (Maximum 6 Years)|Negative changes from Baseline indicate an improvement (i.e., a reduction) in 28-day seizure frequency.|Baseline (8-week Baseline Period from the parent study SP0754 [NCT00136019]), Treatment Period (Maximum 6 years)|Of the 308 subjects who were enrolled/treated in the study, 307 are included in this summary based on the Full Analysis Set (FAS). FAS population: number of subjects treated with at least 1 post-baseline seizure diary day with available data during the SP756 study.||percentage change||Full Range|Median
746301|NCT00522275|Primary|Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 6 Years)|Serious adverse events are any untoward serious medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|During the Treatment Period (Maximum 6 years)|Of the 308 subjects who entered the study, 308 are included in this summary based on the Safety Set (SS). SS population: number of subjects treated.||subjects|||Number
746302|NCT00522275|Primary|Number of Subjects Prematurely Discontinuing Due to a Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (Maximum 6 Years)|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|During the Treatment Period (Maximum 6 years)|Of the 308 subjects who entered the study, 308 are included in this summary based on the Safety Set (SS). SS population: number of subjects treated.||subjects|||Number
746303|NCT00522275|Primary|Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (Maximum 6 Years)|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|During the Treatment Period (Maximum 6 years)|Of the 308 subjects who entered the study, 308 are included in this summary based on the Safety Set (SS). SS population: number of subjects treated.||subjects|||Number
746304|NCT00522301|Primary|Progression-free Survival (PFS) Rate at 12 Months|All 5 patients experienced a rash. As a result, all 5 were either advised to withdraw from the protocol, or withdrew themselves from the protocol. The outcome was not met.|1 year|Protocol terminated prior to primary outcome evaluation. All 5 patient were evaluable for toxicity only.|||||
746305|NCT00522379|Secondary|"The Change in Number of Off Periods From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary"|Time “Off” is defined as when the patient does not have the effect of anti-Parkinson’s medication.|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 405 are included in this analysis. The Observed Cases (OC) method was utilized.||Hours||Standard Deviation|Mean
746306|NCT00522379|Secondary|The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Symptomatic Orthostasis?|"Item = Does the patient have symptomatic orthostasis (question #42) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates subject has symptomatic orthostasis.
Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same."|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 495 are included in this analysis. The Last Observation Carried Forward (LOCF) method was utilized.||participants|||Number
746307|NCT00522379|Secondary|The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Any Sleep Disturbances Such as Insomnia or Hypersomnolence?|"Item = Does the patient have any sleep disturbances such as insomnia or hypersomnolence (question #41) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates subject has sleep disturbances such as insomnia or hypersomnolence.
Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same."|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 495 are included in this analysis. The Last Observation Carried Forward (LOCF) method was utilized.||participants|||Number
746308|NCT00522379|Secondary|The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Anorexia, Nausea, or Vomiting?|"Item = Does the patient have anorexia, nausea, or vomiting (question #40) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates subject has anorexia, nausea, or vomiting.
Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same."|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 495 are included in this analysis. The Last Observation Carried Forward (LOCF) method was utilized.||participants|||Number
746335|NCT00522418|Secondary|Centre for Epidemiologic Studies Depression Scale (CES-D) in Patients With Less Then a 50% Reduction|The Center for Epidemiologic Studies Depression Scale (CES-D) includes 20 items comprising six scales reflecting major dimensions of depression: depressed mood, feelings of guilt and worthlessness, feelings of helplessness and hopelessness, psychomotor retardation, loss of appetite, and sleep disturbance. Possible range of scores is 0 to 60, higher scores indicate more depressive symptoms.|At 12 and 24 months|This study was conducted between February 2006 and July 2008 and was prematurely terminated by Cyberonics, Inc. due to a low enrollment rate and not as a result of a safety or efficacy signal. Because of early termination and limited data this outcome measure was not tabulated.|||||
746309|NCT00522379|Secondary|"The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - What Proportion of the Waking Day is the Subject Off, on Average?"|"Item = What proportion of the waking day is the subject “off”, on average (question #39) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 – 4 points (4 = maximum). A higher score indicates the subject is “off” a larger portion of the waking day.
Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same."|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 495 are included in this analysis. The Last Observation Carried Forward (LOCF) method was utilized.||participants|||Number
746310|NCT00522379|Secondary|"The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Do Off Periods Come on Suddenly?"|"Item = Do “off” periods come on suddenly, within a few seconds (question #38) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates “off” periods come on suddenly, within a few seconds.
Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same."|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 495 are included in this analysis. The Last Observation Carried Forward (LOCF) method was utilized.||participants|||Number
746311|NCT00522379|Secondary|"The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Are Off Periods Unpredictable?"|"Item = Are “off” periods unpredictable (question #37) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates “off” periods are unpredictable.
Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same."|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 495 are included in this analysis. The Last Observation Carried Forward (LOCF) method was utilized.||participants|||Number
746312|NCT00522379|Secondary|"The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Are Off Periods Predictable?"|"Item = Are “off” periods predictable (question #36) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates “off” periods are predictable.
Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same."|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 495 are included in this analysis. The Last Observation Carried Forward (LOCF) method was utilized.||participants|||Number
746313|NCT00522379|Secondary|The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Presence of Early Morning Dystonia|"Item = Presence of Early Morning Dystonia (question #35) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates early morning dystonia.
Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same."|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 495 are included in this analysis. The Last Observation Carried Forward (LOCF) method was utilized.||participants|||Number
746314|NCT00522379|Secondary|The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Painful Dyskinesias: How Painful Are the Dyskinesias?|"Item = Painful Dyskinesia (question #34) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period - How painful are the dyskinesias? Has a possible score of 0 – 4 points (4 = maximum). A higher score indicates more severe symptoms.
Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same."|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 495 are included in this analysis. The Last Observation Carried Forward (LOCF) method utilized.||participants|||Number
746315|NCT00522379|Secondary|The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Disability: How Disabling Are the Dyskinesias?|"Item = Disability (question #33) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period - How disabling are the dyskinesias? Has a possible score of 0 – 4 points (4 = maximum). A higher score indicates more severe symptoms.
Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same."|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 495 are included in this analysis. The Last Observation Carried Forward (LOCF) method utilized.||participants|||Number
746339|NCT00522418|Secondary|Changes in Anti-epileptic Drugs (AEDs)|Change from baseline in number of AED medications by visit|Change from baseline in number of AEDs at 12 months|Due to early study termination & only a few patients (n=7) achieving 2 year follow-up, study data for the 24 month time point is not available. However, at the 12 month time point there was an adequate amount of patient study data for analysis. This outcome measure evaluates the data for fifty-nine (59) patients.||Number of AEDs Taken||Full Range|Median
746442|NCT00523549|Secondary|Change in Ratio of Peak E Wave Velocity/Lateral Mitral Annular Myocardial Relaxation Velocity|Change from baseline in peak E-wave velocity / lateral mitral annular myocardial relaxation velocity (E/E’) at Week 24|Baseline to 24 weeks after treatment|Intent-to-treat||ratio||Standard Deviation|Mean
746316|NCT00522379|Secondary|The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - What Proportion of the Waking Day Are Dyskinesias Present?|"Item = Duration (question #32) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period - What proportion of the waking day are dyskinesias present? Has a possible score of 0 – 4 points (4 = maximum). A higher score indicates more severe symptoms.
Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same."|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 495 are included in this analysis. The Last Observation Carried Forward (LOCF) method utilized.||participants|||Number
746317|NCT00522379|Secondary|The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III From Baseline to the End of the Maintenance Period|The Unified Parkinson's Disease Rating Scale (UPDRS) Part III is a scale for the assessment of function in Parkinson's disease. UPDRS Part III measures Motor Function. It consists of 14 items with 27 questions, each ranging from 0 to 4. The sum score for the UPDRS Part III ranges from 0 to 108. A higher score indicates greater disability. A negative change score indicates improvement.|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 496 are included in this analysis. The Last Observation Carried Forward (LOCF) method utilized.||units on a scale||Standard Deviation|Mean
746318|NCT00522379|Secondary|The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part II From Baseline to the End of the Maintenance Period|The Unified Parkinson's Disease Rating Scale (UPDRS) Part II is a scale for the assessment of function in Parkinson's disease. UPDRS Part II measures Activities of Daily Living. It consists of 13 questions, each ranging from 0 to 4. The sum score of the UPDRS Part II ranges from 0 to 52. A higher score indicates greater disability. A negative change score indicates improvement.|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 497 are included in this analysis. The Last Observation Carried Forward (LOCF) method utilized.||units on a scale||Standard Deviation|Mean
746319|NCT00522379|Secondary|The Change in the Status of the Subject After Wake-Up From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary||From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 405 are included in this analysis.||Hours||Standard Deviation|Mean
746320|NCT00522379|Secondary|"The Change in the Relative Time Spent on From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary"|Time “On” is defined as when the patient has the effect of anti-Parkinson’s medication.|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 502 are included in this analysis. The Last Observation Carried Forward (LOCF) method was utilized.||Hours||Standard Deviation|Mean
746321|NCT00522379|Secondary|"The Change in the Absolute Time Spent on From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary"|Time “On” is defined as when the patient has the effect of anti-Parkinson’s medication.|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 502 are included in this analysis. The Last Observation Carried Forward method was utilized.||Hours||Standard Deviation|Mean
746322|NCT00522379|Secondary|"The Change in Relative Time Spent Off From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary"|Time “Off” is defined as when the patient does not have the effect of anti-Parkinson’s medication.|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 502 are included in this analysis. The Last Observation Carried Forward (LOCF) method was utilized.||Hours||Standard Deviation|Mean
746323|NCT00522379|Primary|"The Change in the Absolute Time Spent Off From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary"|Time “Off” is defined as when the patient does not have the effect of anti-Parkinson’s medication.|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 502 are included in this analysis. The Last Observation Carried Forward (LOCF) method was utilized.||Hours||Standard Deviation|Mean
746324|NCT00522392|Secondary|Change in Quality of Life (QOL) From Baseline to 6 Months Post Consolidation as Assessed by the Functional Assessment of Cancer Therapy-Neurotoxicity Trial Outcome Index (FACT-Ntx TOI)|The combined score on the FACT-Ntx TOI is of interest. The FACT-Ntx TOI has 25 items and the score ranges from 0 (worst possible quality of life) -100 (best possible quality of life). The primary QOL endpoint is defined as the change in the FACT-Ntx TOI score from registration to 6 months post consolidation treatment.|Baseline and 6 months post consolidation treatment|Patients with both assessments complete at baseline and 6 months post consolidation treatment were included in this analysis.||units on a scale||Full Range|Mean
746325|NCT00522392|Secondary|Overall Survival (OS)|Overall survival is defined as the time from randomization to death or date of last known alive. The OS results are based on data as of April 2014.|Assessed every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, every 12 months if patient is 6-10 years from study entry, up to 10 years|All randomized patients||Months||95% Confidence Interval|Median
746336|NCT00522418|Secondary|Quality of Life in Epilepsy - 89 Items(QOLIE-89)in Patients With Less Than a 50% Reduction in Seizures|QOLIE-89 contains 17 multi-item measures of overall quality of life, emotional well-being, role limitations due to emotional problems, social support, social isolation, energy/fatigue, worry about seizure, medication effects, health discouragement, work/driving/social function, attention/concentration, language, memory, physical function, pain, role limitations due to physical problems, and health perceptions. Range of values 0-100. Higher scores reflect better quality of life; lower ones, worse quality of life.|At 12 and 24 months|This study was conducted between February 2006 and July 2008 and was prematurely terminated by Cyberonics, Inc. due to a low enrollment rate and not as a result of a safety or efficacy signal. Because of early termination and limited data this outcome measure was not tabulated.|||||
746326|NCT00522392|Secondary|Response Rates (Complete Response [CR] or Very Good Partial Response [VGPR])|"CR:
Patients with complete disappearance of an M-protein and no evidence of myeloma in the bone marrow are considered to have CR. To be considered CR, patients must meet all of the following criteria:
Negative immunofixation on the serum and urine at two consecutive times
Disappearance of any soft tissue plasmacytomas
≤5% plasma cells in bone marrow
If serum and urine M protein are unmeasurable and the immunoglobulin free light chain (FLC) parameter is being used, patients must have a normal ratio of 0.26-1.65 at two consecutive times
VGPR:
Serum and urine M-component detectable by immunofixation but not on electrophoresis OR
>=90% reduction in serum M-component plus urine M-component <100 mg per 24 hours (by SPEP and UPEP)
If the serum and urine M protein are unmeasurable and the immunoglobulin FLC parameter is being used, a >90% decrease in the difference between involved and uninvolved FLC levels is required in place of the M protein criteria"|Assessed at the end of each cycle, every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, every 12 months if patient is 6-10 years from study entry, up to 10 years|Patients with measurable disease at randomization were included in this analysis.||Proportion of patients||95% Confidence Interval|Number
746327|NCT00522392|Primary|Progression-free Survival (PFS)|"Progression-free survival was defined as the time from randomization to the earliest documentation of disease progression (PD) or death. If a patient died without evidence of PD, the patient was considered an event if death occurred within 3 months of the last disease assessment. Patients who died outside of the specified interval or patients who were alive without evidence of PD were censored at the date of last disease assessment.
The PFS results are based on data as of August 2012, while overall survival (OS) was updated in April 2014. Given the early termination and limited sample size, data management efforts to update PFS were not pursued."|Assessed every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, every 12 months if patient is 6-10 years from study entry, up to 10 years|All randomized patients||Months||95% Confidence Interval|Median
746328|NCT00522418|Secondary|Clinical Global Impressions Scale (CGI) in Patients With Less Then a 50% Reduction in Seizures|The Clinical Global Impression scale (CGI-I)is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention Scores range from 1-7: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.|At 12 and 24 months|This study was conducted between February 2006 and July 2008 and was prematurely terminated by Cyberonics, Inc. due to a low enrollment rate and not as a result of a safety or efficacy signal. Because of early termination and limited data this outcome measure was not tabulated.|||||
746329|NCT00522418|Secondary|Change From Baseline in QOLIE-89 Measures: Subgroup Analysis of Population With Baseline Adverse Event Profile Score < 40|QOLIE-89 contains 17 multi-item measures of overall quality of life. Range of values 0-100. Higher scores reflect better quality of life; lower ones, worse quality of life. Adverse Events Profile (AEP) is a 19-item scale used as a systematic measure of adverse effects from antiepileptic drugs (AEDs). Scores range from 19-76; higher scores indicate high prevelance and severity of adverse events.|Change from baseline up to 12 months|This outcome measure includes patients from both arms VNS + BMP (N=17) and BMP alone (N=17), with an overall QOLIE-89 at baseline and any other baseline visit up to 12 months. Subgroup Analysis of Population With Baseline Adverse Event Profile Score < 40||units on a scale||Standard Error|Least Squares Mean
746330|NCT00522418|Secondary|Change From Baseline in QOLIE-89 Measures: Subgroup Analysis of Population With Baseline Adverse Event Profile Score >= 40|QOLIE-89 contains 17 multi-item measures of overall quality of life. Range of values 0-100. Higher scores reflect better quality of life; lower ones, worse quality of life. Adverse Events Profile (AEP) is a 19-item scale used as a systematic measure of adverse effects from antiepileptic drugs (AEDs). Scores range from 19-76; higher scores indicate high prevelance and severity of adverse events.|Change from baseline up to 12 months|This outcome measure includes patients from both arms, VNS + BMP (N=30) and BMP alone (N=31), with an overall QOLIE-89 at baseline and any other post baseline visit up to 12 months. Subgroup Analysis of population with Baseline Adverse Event Profile Score >= 40||Units on a Scale||Standard Error|Least Squares Mean
746331|NCT00522418|Secondary|Percent of Participants Who Were Compliant With the Protocol|Retention rate in patients with less then a 50% reduction in seizures|At 12 and 24 months|This study was conducted between February 2006 and July 2008 and was prematurely terminated by Cyberonics, Inc. due to a low enrollment rate and not as a result of a safety or efficacy signal. Because of early termination and limited data this outcome measure was not tabulated.|||||
746332|NCT00522418|Secondary|Change in the Number of Anti-epileptic Drugs Prescribed|Changes in Anti-Epileptic Drugs (AEDs) in patients with less then a 50% reduction in seizures|At 12 and 24 months|This study was conducted between February 2006 and July 2008 and was prematurely terminated by Cyberonics, Inc. due to a low enrollment rate and not as a result of a safety or efficacy signal. Because of early termination and limited data this outcome measure was not tabulated.|||||
746333|NCT00522418|Secondary|Adverse Event Profile (AEP) in Patients With Less Then a 50% Reduction in Seizures|Adverse Events Profile (AEP) is a 19-item scale used as a systematic measure of adverse effects from antiepileptic drugs (AEDs). Scores range from 19-76; higher scores indicate high prevelance and severity of adverse events.|At 12 and 24 months|This study was conducted between February 2006 and July 2008 and was prematurely terminated by Cyberonics, Inc. due to a low enrollment rate and not as a result of a safety or efficacy signal. Because of early termination and limited data this outcome measure was not tabulated.|||||
746334|NCT00522418|Secondary|Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) in Patients With Less Then a 50% Reduction in Seizures|The Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) is a 6-item questionnaire validated to screen for depression in people with epilepsy. Scores range from 6 to 24, with higher scores indicating more depressive symptoms.|At 12 and 24 months|This study was conducted between February 2006 and July 2008 and was prematurely terminated by Cyberonics, Inc. due to a low enrollment rate and not as a result of a safety or efficacy signal. Because of early termination and limited data this outcome measure was not tabulated.|||||
746443|NCT00523549|Secondary|Change in Left Atrial Size|Change from baseline in left atrial size at Week 24|Baseline to 24 weeks after treatment|Intent-to-treat||cm||Standard Deviation|Mean
746444|NCT00523549|Primary|Change in Lateral Mitral Annular Myocardial Relaxation Velocity|Change from baseline in lateral mitral annular myocardial relaxation velocity (E’) at Week 24|Baseline to 24 weeks after treatment|Intent-to-treat||cm/s||Standard Deviation|Mean
746340|NCT00522418|Secondary|Change From Baseline in Adverse Event Profile (AEP) Score|Adverse Events Profile (AEP) is a 19-item scale used as a systematic measure of adverse effects from antiepileptic drugs (AEDs). Scores range from 19-76; higher scores indicate high prevelance and severity of adverse events.|Mean change from baseline AEP Score at 12 months|Due to early study termination & only a few patients (n=7) achieving 2 year follow-up, study data for the 24 month time point is not available. However, at the 12 month time point there was an adequate amount of patient study data for analysis. This outcome measure evaluates the data for sixty (60) patients.||Units on a scale||Standard Deviation|Mean
746341|NCT00522418|Secondary|Mean Change From Beginning of Intervention Clinical Global Impression-Improvement Scale (CGI-I) Score at 12 Months|The Clinical Global Impression scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention Scores range from 1-7: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.|Mean change from baseline CGI-I Score at 12 months|Due to early study termination & only a few patients (n=7) achieving 2 year follow-up, study data for the 24 month time point is not available. However, at the 12 month time point there was an adequate amount of patient study data for analysis. This outcome measure evaluates the data for sixty (60) patients.||Units on a Scale||Standard Deviation|Mean
746342|NCT00522418|Secondary|Change From Baseline in Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) Score|The Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) is a 6-item questionnaire validated to screen for depression in people with epilepsy. Scores range from 6 to 24, with higher scores indicating more depressive symptoms.|Mean change from baseline NDDI-E Score at 12 months|Due to early study termination & only a few patients (n=7) achieving 2 year follow-up, study data for the 24 month time point is not available. However, at the 12 month time point there was an adequate amount of patient study data for analysis. This outcome measure evaluates the data for sixty (60) patients.||Units on a Scale||Standard Deviation|Mean
746343|NCT00522418|Secondary|Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) Score|The Center for Epidemiologic Studies Depression Scale (CES-D) includes 20 items comprising six scales reflecting major dimensions of depression: depressed mood, feelings of guilt and worthlessness, feelings of helplessness and hopelessness, psychomotor retardation, loss of appetite, and sleep disturbance. Possible range of scores is 0 to 60, higher scores indicate more depressive symptoms.|Mean change from baseline CES-D Score at 12 months|Due to early study termination & only a few patients (n=7) achieving 2 year follow-up, study data for the 24 month time point is not available. However, at the 12 month time point there was an adequate amount of patient study data for analysis. This outcome measure evaluates the data for sixty (60) patients.||Units on a Scale||Standard Deviation|Mean
746344|NCT00522418|Secondary|Seizure Free Days Over the Last 6 Months||Over the last 6 months|This study was conducted between February 2006 and July 2008 and was prematurely terminated by Cyberonics, Inc. due to a low enrollment rate and not as a result of a safety or efficacy signal. Because of early termination and limited data this outcome measure was not tabulated.|||||
746345|NCT00522418|Secondary|Seizure Free Days|Seizure free days is defined as the time from last seizure to study exit date.|From the patient's last seizure to the study exit date|This study was conducted between February 2006 and July 2008 and was prematurely terminated by Cyberonics, Inc. due to a low enrollment rate and not as a result of a safety or efficacy signal. Because of early termination and limited data this outcome measure was not tabulated.|||||
746346|NCT00522418|Secondary|Mean Percent Change in Seizure Frequency|Percent change in total seizuires per week from baseline at 12 months|Mean percent change from baseline in seizure frequency at 12 months|Due to early study termination & only a few patients (n=7) achieving 2 year follow-up, study data for the 24 month time point is not available. However, at the 12 month time point there was an adequate amount of patient study data for analysis. This outcome measure evaluates the data for sixty (60) patients.||Percent Change||Standard Deviation|Mean
746347|NCT00522418|Secondary|Percent of Patients That Are Seizure Free|Percent of patients that are seizure free as defined by no seizures during the preceding follow-up period.|3, 6, 9, 12, 15, 18, 21, 24 months|This study was conducted between February 2006 and July 2008 and was prematurely terminated by Cyberonics, Inc. due to a low enrollment rate and not as a result of a safety or efficacy signal. Because of early termination and limited data this outcome measure was not tabulated.|||||
746348|NCT00522418|Secondary|Response Rate|Response Rate is defined as the percent of participants who are responders. A Responder is defined as participants with a reduction of at least 50% or 75% in seizure frequency from baseline to the seizure count evaluation period.|Number of Responders at 12 Months|Due to early study termination & only a few patients (n=7) achieving 2 year follow-up, study data for the 24 month time point is not available. However, at the 12 month time point there was an adequate amount of patient study data for analysis. This outcome measure evaluates the data for sixty (60) patients.||participants|||Number
746349|NCT00522418|Primary|Overall Quality of Life in Epilepsy-89 (QOLIE-89) Score in Patients With Baseline & at Least One Post-baseline QOLIE Assessment|QOLIE-89 contains 17 multi-item measures of overall quality of life, emotional well-being, role limitations due to emotional problems, social support, social isolation, energy/fatigue, worry about seizure, medication effects, health discouragement, work/driving/social function, attention/concentration, language, memory, physical function, pain, role limitations due to physical problems, and health perceptions. Range of values 0-100. Higher scores reflect better quality of life; lower ones, worse quality of life.|Mean change from baseline QOLIE-89 Overall Score at 12 months|Due to early study termination & only a few patients (n=7) achieving 2 year follow-up, study data for the 24 month time point is not available. However, at the 12 month time point there was an adequate amount of patient study data for analysis. This outcome measure evaluates the data for sixty (60) patients.||units on a scale||Standard Deviation|Mean
746350|NCT00522431|Secondary|Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration (Cmax) Criteria at Day 90|Percentage of participants with Cmax ≤1500 ng/dL, 1800-2500 ng/dL, and >2500 ng/dL|0, 0.5, 1, 2, 4, 6, 8, 10, 12 and 24 hours after study drug application on day 90|Modified intent-to-treat (mITT) population included participants who had more than 1 pharmacokinetic (PK) sample obtained during the 24-hour PK profile on day 90 (11 participants were excluded); data from 9 additional participants were excluded due to insufficient backup samples needed for reanalysis||percentage of participants|||Number
746351|NCT00522431|Primary|Percentage of Participants Meeting Serum Total Testosterone Average Concentration (Cavg) Criteria at Day 90|Percentage of participants with Cavg0-24h ≥300-≤1140 ng/dL|0, 0.5, 1, 2, 4, 6, 8, 10, 12 and 24 hours after study drug application on day 90|Modified intent-to-treat (mITT) population included participants who had more than 1 pharmacokinetic (PK) sample obtained during the 24-hour PK profile on day 90 (11 participants were excluded); data from 9 additional participants were excluded due to insufficient backup samples needed for reanalysis||percentage of participants||95% Confidence Interval|Number
746352|NCT00522457|Secondary|Clinical Benefit Rate|The study was prematurely terminated, therefore no participants were analyzed|patients are monitored for 6 months|The study was prematurely terminated, therefore no participants were analyzed||participants|||Number
746353|NCT00522457|Secondary|Duration of Response|The study was prematurely terminated, therefore no participants were analyzed|patients are monitored for 6 months|The study was prematurely terminated, therefore no participants were analyzed||participants|||Number
746354|NCT00522457|Primary|Clinical Efficacy Measured by Objective Response Rate (Best Response During the Course of the Study)||patients are monitored for 6 months|The study was prematurely terminated, therefore no participants were analyzed. The primary endpoint was the objective response rate (ORR) to ertumaxomab (best response during the course of the study), defined as the number of patients with CR or PR according to RECIST, relative to the total population of treated patients||participants|||Number
746355|NCT00522626|Secondary|Maternal Physiologic Parameters||120 minutes||||||
746356|NCT00522626|Primary|Fetal Heart Rate|Fetal heart rate in beats per minute|60 minutes|Total number of subjects completing assessment||beats per minute||Standard Deviation|Mean
746357|NCT00522795|Primary|Complete Pathologic Response|Per pathology review post surgery|At Surgery approximately 4weeks after last treatment|Twelve of 37 patients (32%) had pathologic complete responses. The 12 patients with pathologic CR all had adenocarcinoma.||participants|||Number
746358|NCT00522873|Secondary|Number of Participants With Amenorrhea During Month 10 to 12 of Treatment|The women were to record any bleeding daily in a diary, indicating 'no bleeding', 'spotting', 'light bleeding', 'normal bleeding' or 'heavy bleeding'. Women were considered to have amenorrhea if they had no bleeding and no spotting day within the given time interval.|Month 10 to Month 12|Per protocol set (PPS): All subjects from the FAS who had at least 75% overall study drug compliance and no major protocol violations||Participants|||Number
746359|NCT00522873|Secondary|Number of Participants With Amenorrhea During Month 1 to 3 of Treatment|The women were to record daily in a diary, indicating 'no bleeding', 'spotting', 'light bleeding', 'normal bleeding' or 'heavy bleeding'. Women were considered to have amenorrhea if they had no bleeding and no spotting day within the given time interval.|Month 1 to Month 3|Per protocol set (PPS): All subjects from the FAS who had at least 75% overall study drug compliance and no major protocol violations||Participants|||Number
746360|NCT00522873|Primary|Number of Participants in the DRSP/E2 Group With an Assessment of Endometrial Hyperplasia or Worse at End of Study (EoS) (1 Year of Treatment)|The number of women who had a biopsy classified as 'hyperplasia or worse' at any time during the study. According to the protocol this endpoint was defined as primary for the DRSP/E2 group only.|Up to one year|For the DRSP/E2 group only - Primary analysis set (PAS): All subjects from the full analysis set (FAS) who either had a biopsy result classified as ‘normal’ or ‘hyperplasia or worse’ after a year of treatment or who prematurely discontinued the study before Cycle 13 with a biopsy classified as ‘hyperplasia or worse’.||Participants|||Number
746361|NCT00522925|Secondary|Change From Baseline in Mean Seated Systolic and Diastolic Blood Pressure||4 weeks of treatment with PS43540||||||
746362|NCT00522925|Secondary|Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure||4 weeks of treatment with PS43540||||||
746363|NCT00522925|Primary|Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure||4 weeks of treatment with PS43540|||mmHg||95% Confidence Interval|Mean
746364|NCT00522951|Secondary|Intraclass Correlation Coefficient (ICC) Among 3 Blinded Readers on the Number of Detected Lesions|ICC among 3 blinded readers calculated for number of detected lesions using the statistical model with two random effects, i.e., blinded readers and individual patients.|one day|Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.||ICC|||Number
746365|NCT00522951|Secondary|Contrast Noise Ratio (CNR) of Lesions Evaluated by Independent Radiologist|CNR of lesion/normal white matter based on the signal intensity of MR images evaluated by independent radiologist (mean and standard deviation of 306 lesions)|one day|Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.||CNR||Standard Deviation|Mean
746366|NCT00522951|Secondary|Lesion Size Evaluated by Independent Radiologist|Size of each lesion on postcontrast MR images evaluated by independent radiologist (mean and standard deviation of 603 lesions)|one day|Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.||mm||Standard Deviation|Mean
746367|NCT00522951|Secondary|Number of Participants With Reasons for Performance in SRS Planning by Investigator|Reasons for comparison results of overall image quality for SRS treatment planning between gadobutrol and gadoteridol by investigator (multiple answers applicable)|one day|Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), whose images were assessed as “confident in treatment planning” with gadobutrol and ProHance, and who were assessed as applicable for SRS, and had valid data for this Outcome Measure||participants|||Number
746368|NCT00522951|Secondary|Number of Participants With Reasons for Performance in SRS Planning by TPE|Reasons for comparison results of overall image quality for SRS treatment planning between gadobutrol and gadoteridol by investigator (multiple answers applicable)|one day|Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), whose images were assessed as “confident in treatment planning” with gadobutrol and ProHance, and who were assessed as applicable for SRS, and had valid data for this Outcome Measure||participants|||Number
746470|NCT00517296|Secondary|Changes in Disease Activity|Changes in Crohn's disease activity using the Harvey Bradshaw Index (HBI) at Week 48 compared to baseline HBI Scores. Higher numbers for the HBI equal more significant disease activity. Range can vary from 0 to 17 plus the number of liquid stools per day.|Baseline and 48 Weeks|||units on a scale||Inter-Quartile Range|Mean
746369|NCT00522951|Secondary|Number of Participants With Performance in Stereotactic Radiosurgery (SRS) Planning by Investigator|Comparison of overall image quality for SRS treatment planning between gadobutrol and gadoteridol by investigator|one day|Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), whose images were assessed as “confident in treatment planning” with gadobutrol and ProHance, and who were assessed as applicable for SRS, and had valid data for this Outcome Measure||participants|||Number
746370|NCT00522951|Secondary|Number of Participants With Performance in Stereotactic Radiosurgery (SRS) Planning by TPE|Comparison of overall image quality for SRS treatment planning between gadobutrol and gadoteridol by TPE|one day|Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), whose images were assessed as “confident in treatment planning” with gadobutrol and ProHance, and who were assessed as applicable for SRS, and had valid data for this Outcome Measure||participants|||Number
746371|NCT00522951|Secondary|Treatment Planning Confidence - Gadobutrol 0.2 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Investigator|Treatment planning confidence evaluated separately for each image set (gadobutrol 0.2 mmol/kg bw and gadoteridol 0.2 mmol/kg) by investigator (category: not confident, confident, and not assessable)|one day|Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.||participants|||Number
746372|NCT00522951|Secondary|Treatment Planning Confidence - Gadobutrol 0.2 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by TPE|Treatment planning confidence evaluated separately for each image set (gadobutrol 0.2 mmol/kg bw and gadoteridol 0.2 mmol/kg) by TPE (category: not confident, confident, and not assessable)|one day|Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.||participants|||Number
746373|NCT00522951|Secondary|Treatment Planning Confidence - Gadobutrol 0.1 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Investigator|Treatment planning confidence evaluated separately for each image set (gadobutrol 0.1 mmol/kg bw and gadoteridol 0.2 mmol/kg) by investigator (category: not confident, confident, and not assessable)|one day|Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.||participants|||Number
746374|NCT00522951|Secondary|Treatment Planning Confidence - Gadobutrol 0.1 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Treatment Planning Experts (TPE)|Treatment planning confidence evaluated separately for each image set (gadobutrol [Gado-] 0.1 mmol/kg bw and gadoteridol [Pro-] 0.2 mmol/kg) by TPE (category: not confident, confident, and not assessable)|one day|Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.||participants|||Number
746375|NCT00522951|Secondary|Score of Visibility Assessment - Border Delineation by Investigator|Border delineation for each lesion on postcontrast MR images using the 4-point scale by investigator (Score 1=None, 2=Moderate, 3=Good, 4=Excellent)|one day|Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.||scores on a scale||Standard Deviation|Mean
746376|NCT00522951|Secondary|Score of Visibility Assessment - Border Delineation by Blinded Reader|Border delineation for each lesion on postcontrast MR images using the 4-point scale by averaged blinded reader (Score 1=None, 2=Moderate, 3=Good, 4=Excellent)|one day|Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.||scores on a scale||Standard Deviation|Mean
746377|NCT00522951|Secondary|Score of Visibility Assessment - Degree of Lesion Contrast Enhancement by Investigator|Degree of contrast enhancement for each lesion on postcontrast MR images using the 4-point scale by investigator (Score 1=No, 2=Moderate, 3=Good, 4=Excellent)|one day|Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.||scores on a scale||Standard Deviation|Mean
746378|NCT00522951|Secondary|Score of Visibility Assessment - Degree of Lesion Contrast Enhancement by Blinded Reader|Degree of contrast enhancement for each lesion on postcontrast MR images using the 4-point scale by averaged blinded reader (Score 1=No, 2=Moderate, 3=Good, 4=Excellent)|one day|Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.||scores on a scale||Standard Deviation|Mean
746379|NCT00522951|Primary|Number of Lesions Detected by Blinded Readers (BR) and Investigator|Number of metastatic lesions (unenhanced and enhanced) per participant detected on postcontrast Magnetic resonance (MR) images by averaged blinded reader and investigator|one day|Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.||lesions||Standard Deviation|Mean
746380|NCT00523237|Primary|The Percentage of Patients Who Maintain a Viral Load < 50 Copies/ml After Being Switched From Enfuvirtide to Raltegravir|evaluate the percent of patients with viral load of <50 copies at week 24 of study after being switched from enfuvirtide to raltegravir|24 weeks|With expected man baseline residual viremia of 5 copies/ml and predicted standard deviation of 3 in change of residual viremia, our study was predicted to have 80% power to detect a difference of 2.5 copies/ml in residual viremia with =0.05.||percentage|||Number
746381|NCT00523341|Secondary|Bone Histology at Month 84|Bone biopsy samples were prepared according to standard procedures for bone histology to determine if there were any histological abnormalities in the bone. Results are reported for the number of biopsies with normal bone micro-architecture: normal lamellar bone, normal mineralization, and osteoid, and biopsies with abnormal bone histology: osteomalacia, marrow fibrosis, or woven bone.|Month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, and had at least 1 bone biopsy evaluable for histology at extension month 84.||biopsies|biopsies||Number
746401|NCT00523341|Secondary|Bone Histomorphometry: Osteoid Surface|Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. Osteoid surface is the percent of bone surface covered in osteoid.|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available osteoid surface data.||percentage of total bone surface||Standard Deviation|Mean
746382|NCT00523341|Secondary|Bone Histology at Month 24|Bone biopsy samples were prepared according to standard procedures for bone histology to determine if there were any histological abnormalities in the bone. Results are reported for the number of biopsies with normal bone micro-architecture: normal lamellar bone, normal mineralization, and osteoid, and biopsies with abnormal bone histology: osteomalacia, marrow fibrosis, or woven bone.|Month 24|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, and had at least 1 bone biopsy evaluable for histology at extension month 24.||biopsies|biopsies||Number
746383|NCT00523341|Secondary|Bone Histomorphometry: Mineralization Lag Time|"Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. A double tetracycline labeling procedure was used to allow visualization and quantification of sites of new bone formation. Tetracycline was given for two periods of 3 days separated by 14 days where no tetracycline was taken.
Mineralization lag time is the average time interval between osteoid formation and its subsequent mineralization and is calculated by dividing the osteoid width by the apposition rate."|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available mineralization lag time data.||days||Standard Deviation|Mean
746384|NCT00523341|Secondary|Bone Histomorphometry: Osteoid Volume|"Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.
Osteoid volume is the percentage of a given volume of bone tissue that consists of unmineralized bone (osteoid)."|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available osteoid volume data.||percentage of total bone tissue||Standard Deviation|Mean
746385|NCT00523341|Secondary|Bone Histomorphometry: Activation Frequency|"Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.
A double tetracycline labeling procedure was used to allow visualization and quantification of sites of new bone formation. Tetracycline was given for two periods of 3 days separated by 14 days where no tetracycline was taken. The average time that it takes for a new remodeling cycle to begin on any point on a cancellous surface is called the activation frequency. Activation frequency is calculated as the bone formation rate / wall width."|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available activation frequency data.||/year||Standard Deviation|Mean
746386|NCT00523341|Secondary|Bone Histomorphometry: Formation Period|"Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.
A double tetracycline labeling procedure was used to allow visualization and quantification of sites of new bone formation. Tetracycline was given for two periods of 3 days separated by 14 days where no tetracycline was taken. Formation period (FP) is the mean time required to rebuild a new bone structural unit or osteon from the cement line back to the bone surface at a single location, and is given by wall width / adjusted apposition rate."|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available formation period data.||days||Standard Deviation|Mean
746387|NCT00523341|Secondary|Bone Histomorphometry: Bone Formation Rate - Volume Based|"Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.
A double tetracycline labeling procedure was used to allow visualization and quantification of sites of new bone formation. Tetracycline was given for two periods of 3 days separated by 14 days where no tetracycline was taken. Bone formation rate - volume based is the calculated rate at which cancellous bone volume is being replaced annually, derived from the Mineral Appositional Rate * 365 * (relative mineralizing surface / total bone volume)."|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available bone formation rate data.||percent of bone volume per year||Standard Deviation|Mean
746388|NCT00523341|Secondary|Bone Histomorphometry: Bone Formation Rate - Surface Based|"Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.
A double tetracycline labeling procedure was used to allow visualization and quantification of sites of new bone formation. Tetracycline was given for two periods of 3 days separated by 14 days where no tetracycline was taken. Bone formation rate - surface based is the calculated rate at which cancellous bone surface is being replaced annually, derived from the Mineral Appositional Rate * 365 * (relative mineralizing surface / total bone surface)."|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available bone formation rate data.||μm³/μm²/year||Standard Deviation|Mean
746389|NCT00523341|Secondary|Bone Histomorphometry: Adjusted Apposition Rate|"Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.
A double tetracycline labeling procedure was used to allow visualization and quantification of sites of new bone formation. Tetracycline was given for two periods of 3 days separated by 14 days where no tetracycline was taken. The mineral apposition rate (MAR) is the average rate at which new bone mineral is being added on any actively forming surface. Adjusted MAR is calculated as: (average distance between visible labels / labeling interval) * (total mineralizing surface/total bone surface)."|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available adjusted apposition rate data.||μm/day||Standard Deviation|Mean
746400|NCT00523341|Secondary|Bone Histomorphometry: Osteoid Thickness|Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. Osteoid thickness (width) is the mean thickness of osteoid seams on cancellous surfaces. Osteoid thickness is normally <12.5 µm. Increased osteoid thickness suggests abnormal mineralization (osteomalacia).|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available osteoid thickness data.||μm||Standard Deviation|Mean
746390|NCT00523341|Secondary|Bone Histomorphometry: Mineral Apposition Rate|"Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.
A double tetracycline labeling procedure was used to allow visualization and quantification of sites of new bone formation. Tetracycline was given for two periods of 3 days separated by 14 days where no tetracycline was taken. The mineral apposition rate (MAR) is the avarage rate at which new bone mineral is being added on any actively forming surface. MAR is calculated as the average distance between visible labels, divided by the labeling interval."|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available mineral apposition rate data.||μm/day||Standard Deviation|Mean
746391|NCT00523341|Secondary|Bone Histomorphometry: Mineralizing Surface|"Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.
A double tetracycline labeling procedure was used to allow visualization and quantification of sites of new bone formation. Tetracycline was given for two periods of 3 days separated by 14 days where no tetracycline was taken. Total mineralizing surfaces (MS) include all double and half of single-labeled surfaces. MS is expressed as a percentage of total bone surface."|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available mineralizing surface data.||percentage of bone surface||Standard Deviation|Mean
746392|NCT00523341|Secondary|Bone Histomorphometry: Double-label Surface|"Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.
A double tetracycline labeling procedure was used to allow visualization and quantification of sites of new bone formation. Tetracycline was given for two periods of 3 days separated by 14 days where no tetracycline was taken. The presence of double labels indicates that normal bone mineralization was actively occurring over the entire labeling interval. Double-label surface is expressed as a percentage of total bone surface."|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available double-label surface data.||percentage of bone surface||Standard Deviation|Mean
746393|NCT00523341|Secondary|Bone Histomorphometry: Single-label Surface|"Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.
A double tetracycline labeling procedure was used to allow visualization and quantification of sites of new bone formation. Tetracycline was given for two periods of 3 days separated by 14 days where no tetracycline was taken. A single label is deposited if formation either started or ended during the interval between the uses of the two courses of tetracycline administration. Single-label surface is expressed as a percentage of total bone surface."|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available single-label surface data.||percentage of bone surface||Standard Deviation|Mean
746394|NCT00523341|Secondary|Bone Histomorphometry: Osteoclast Number by TRAP - Surface Based|"Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.
Osteoclast number was measured using TRAP staining and is expressed per 100 mm of bone surface.
Da"|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available osteoclast number data.||1/100 mm||Standard Deviation|Mean
746395|NCT00523341|Secondary|Bone Histomorphometry: Osteoclast Number by TRAP - Length Based|"Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.
Osteoclast number was measured using TRAP staining and is expressed per mm of bone."|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available osteoclast number data.||1/mm||Standard Deviation|Mean
746396|NCT00523341|Secondary|Bone Histomorphometry: Osteoclast Number - Surface Based|"Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.
Osteoclast number was measured by quantitative histomorphometry and is expressed per 100 mm of bone surface area."|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available osteoclast number data.||1/100 mm||Standard Deviation|Mean
746397|NCT00523341|Secondary|Bone Histomorphometry: Osteoclast Number - Length Based|"Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.
Osteoclast number was measured by quantitative histomorphometry and is expressed per mm of bone."|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available osteoclast number data.||1/mm||Standard Deviation|Mean
746398|NCT00523341|Secondary|Bone Histomorphometry: Eroded Surface/Bone Surface|"Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.
Eroded surface/bone surface is the percentage of bone surface occupied by eroded (resorption) cavities (Howships lacunae), with or without osteoclasts."|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available eroded surface/bone surface data.||percentage of bone surface||Standard Deviation|Mean
746399|NCT00523341|Secondary|Bone Histomorphometry: Wall Thickness|Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. Wall thickness is the average thickness of trabecular bone structural units (BSU) and is used to assess the overall balance between resorption and formation.|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available wall thickness data.||μm||Standard Deviation|Mean
746471|NCT00517296|Primary|Number of Participants With Durable Fistula Healing|Complete cessation of fistula drainage at 48 weeks|at week 48|||participants|||Number
746402|NCT00523341|Secondary|Bone Histomorphometry: Osteoblast - Osteoid Interface|Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. Osteoblast - osteoid interface is calculated as osteoblast surface / osteoid surface * 100.|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available osteoblast - osteoid interface data.||percentage of osteoid surface||Standard Deviation|Mean
746403|NCT00523341|Secondary|Bone Histomorphometry: Surface Density|Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. Surface density is calculated by total bone (trabecular) surfaces / total tissue volume.|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available surface density data.||mm²/mm³||Standard Deviation|Mean
746404|NCT00523341|Secondary|Bone Histomorphometry: Cancellous Bone Volume by TRAP Histomorphometry|Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. Cancellous (trabecular) bone volume is the percent of the total marrow cavity that is occupied by cancellous bone (both mineralized and non-mineralized) measured by tartrate-resistant acid phosphatase (TRAP) staining histomorphometry.|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available cancellous bone volume data.||percentage of total bone tissue volume||Standard Deviation|Mean
746405|NCT00523341|Secondary|Bone Histomorphometry: Cortical Width|Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. Cortical width is the average width of both inner and outer cortices.|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available cortical width data.||μm||Standard Deviation|Mean
746406|NCT00523341|Secondary|Bone Histomorphometry: Trabecular Thickness|Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. Mean trabecular thickness is a measure of trabecular structure and is calculated as the reciprocal of total bone (trabecular) surfaces. Trabecular thickness is reduced by aging and osteoporosis.|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available trabecular thickness data.||μm||Standard Deviation|Mean
746407|NCT00523341|Secondary|Bone Histomorphometry: Trabecular Separation|Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. Trabecular separation is the mean distance between trabeculae (measured by integrated computer graphics). Trabecular separation increases with trabecular bone loss.|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available trabecular separation data.||μm||Standard Deviation|Mean
746408|NCT00523341|Secondary|Bone Histomorphometry: Trabecular Number|Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. Trabecular number is the number of trabeculae present per lineal mm and is calculated as trabecular bone volume/trabecular thickness. Trabecular number is a measure of trabecular connectivity and decreases with bone loss.|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available trabecular number data.||1/mm||Standard Deviation|Mean
746409|NCT00523341|Secondary|Bone Histomorphometry: Cancellous Bone Volume|Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. Cancellous (trabecular) bone volume is the percent of the total marrow cavity that is occupied by cancellous bone (both mineralized and non-mineralized) measured by quantitative histomorphometry.|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available cancellous bone volume data.||percentage of total bone tissue volume||Standard Deviation|Mean
746410|NCT00523341|Secondary|Serum Denosumab Concentration|Serum concentrations of denosumab were measured by a validated conventional sandwich enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 0.8 ng/mL. Values of 0 in the table below indicate data below the lower limit of quantification.|Baseline (pre-dose in extension study), day 10, and Months 3, 4 and 6 (pre-dose)|Participants who participated in the Study 20030216 PK substudy, for whom dosing information was not missing and for whom sampling was within 14 days of specified sampling times.||ng/mL||Standard Deviation|Mean
746411|NCT00523341|Secondary|Percent Change From Baseline in Albumin-adjusted Serum Calcium at Day 10||Baseline (of extension study) and day 10|Participants who had a calcium corrected by albumin measurement within the Day 10 visit window up to May 31, 2008.||percent change||Inter-Quartile Range|Median
746412|NCT00523341|Secondary|Percent Change From Study 20030216 Baseline in P1NP by Visit|Bone turnover markers were collected in a subset of participants who participated in the 20030216 Bone Marker sub-study and in new participants continuing beyond month 24 who were not previously in the Bone Turnover Markers sub-study.|Study 20030216 Baseline and extension study day 10, and months 6, 12, 24, 36, 48, 60, 72, and 84|"Participants who received at least 1 dose of denosumab and enrolled in the bone turnover marker substudy at screening or Month 24 in Study 20060289. n indicates the number of participants with available data at each time point."||percent change||Inter-Quartile Range|Median
746413|NCT00523341|Secondary|Percent Change From Study 20030216 Baseline in CTX-1 by Visit|Bone turnover markers were collected in a subset of participants who participated in the 20030216 Bone Marker sub-study and in new participants continuing beyond month 24 who were not previously in the Bone Turnover Markers sub-study.|Study 20030216 Baseline and extension study day 10, and months 6, 12, 24, 36, 48, 60, 72, and 84|"Participants who received at least 1 dose of denosumab and enrolled in the bone turnover marker substudy at screening or Month 24 in Study 20060289. n indicates the number of participants with available data at each time point."||percent change||Inter-Quartile Range|Median
746414|NCT00523341|Secondary|Percent Change From Baseline in Procollagen Type 1 N-telopeptide (P1NP) by Visit|Bone turnover markers were collected in a subset of participants who participated in the 20030216 Bone Marker sub-study and in new sparticipants continuing beyond month 24 who were not previously in the Bone Turnover Markers sub-study.|Baseline (of extension study), day 10, and months 6, 12, 24, 36, 48, 60, 72, and 84|"Participants who received at least 1 dose of denosumab and enrolled in the bone turnover marker substudy at screening or Month 24 in Study 20060289. n indicates the number of participants with available data at each time point."||percent change||Inter-Quartile Range|Median
746415|NCT00523341|Secondary|Percent Change From Baseline in C-Telopeptide 1 (CTX-1) by Visit|Bone turnover markers were collected in a subset of participants who participated in the 20030216 Bone Marker sub-study and in new participants continuing beyond month 24 who were not previously in the Bone Turnover Markers sub-study.|Baseline (of extension study), day 10, and months 6, 12, 24, 36, 48, 60, 72, and 84|"Participants who received at least 1 dose of denosumab and enrolled in the bone turnover marker substudy at screening or Month 24 in Study 20060289. n indicates the number of participants with available data at each time point."||percent change||Inter-Quartile Range|Median
746416|NCT00523341|Secondary|Number of Participants With Non-Vertebral Fractures|Non-vertebral fractures (osteoporotic) were defined as a fracture present on a copy of radiographs or other diagnostic images such as computerized tomography (CT) or magnetic resonance imaging (MRI) confirming the fracture, and/or documented in a copy of the radiology report, surgical report, or discharge summary, excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges. In addition, fractures associated with high trauma severity or pathologic fractures were excluded.|84 months|All enrolled participants||participants|||Number
746417|NCT00523341|Secondary|Number of Participants With New Vertebral Fractures|A new vertebral fracture, assessed by lateral spine X-ray using Genant semiquantitative scoring method, was identified as an ≥ 1 grade increase from the previous grade of 0 in any vertebra from T4 to L4, excluding any fracture associated with high trauma severity or a pathologic fracture.|84 months|All participants enrolled in the extension study who have vertebral X-ray assessment at the extension baseline and at least 1 post-extension baseline visit.||participants|||Number
746418|NCT00523341|Secondary|Percent Change From Study 20030216 Baseline in 1/3 Radius BMD by Visit|1/3 radius BMD was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. Measurements at some time points during the core study 20030216 were only taken in a subset of participants.|Study 20030216 baseline and extension study months 12, 24, 36, 60, and 84|"Participants in the DXA substudy with an Extension Study baseline and at least 1 post-baseline DXA BMD measurement. n indicates the number of participants with available data at each time point."||percent change||95% Confidence Interval|Least Squares Mean
746419|NCT00523341|Secondary|Percent Change From Study 20030216 Baseline in Femoral Neck BMD by Visit|Femoral neck bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. Measurements at some time points during the core study 20030216 were only taken in a subset of participants.|Study 20030216 baseline and extension study months 12, 24, 36, 60 and 84|"Participants with an Extension Study baseline and at least 1 post-baseline DXA BMD measurement. n indicates the number of participants with available data at each time point."||percent change||95% Confidence Interval|Least Squares Mean
746420|NCT00523341|Secondary|Percent Change From Study 20030216 Baseline in Total Hip BMD by Visit|Total hip bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. Measurements at some time points during the core study 20030216 were only taken in a subset of participants.|Study 20030216 baseline and extension study months 12, 24, 36, 60 and 84|"Participants with an Extension Study baseline and at least 1 post-baseline DXA BMD measurement. n indicates the number of participants with available data at each time point."||percent change||95% Confidence Interval|Least Squares Mean
746421|NCT00523341|Secondary|Percent Change From Study 20030216 Baseline in Lumbar Spine Bone Mineral Density by Visit|Lumbar spine bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. Measurements at some time points during the core study 20030216 were only taken in a subset of participants.|Study 20030216 baseline and extension study months 12, 24, 36, 60 and 84|"Participants with an Extension Study baseline and at least 1 post-baseline DXA BMD measurement. n indicates the number of participants with available data at each time point."||percent change||95% Confidence Interval|Least Squares Mean
746422|NCT00523341|Secondary|Percent Change From Baseline in 1/3 Radius Bone Mineral Density by Visit|1/3 radius bone mineral density was measured in a subset of participants by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.|Baseline (of extension study) and months 12, 24, 36, 60 and 84|"Participants in the DXA substudy with an Extension Study baseline and at least 1 post-baseline DXA BMD measurement. n indicates the number of participants with available data at each time point."||percent change||95% Confidence Interval|Least Squares Mean
746423|NCT00523341|Secondary|Percent Change From Baseline in Femoral Neck Bone Mineral Density by Visit|Femoral neck bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.|Baseline (of extension study) and months 12, 24, 36, 60 and 84|"Participants with an Extension Study baseline and at least 1 post-baseline DXA BMD measurement. n indicates the number of participants with available data at each time point."||percent change||95% Confidence Interval|Least Squares Mean
746424|NCT00523341|Secondary|Percent Change From Baseline in Total Hip Bone Mineral Density by Visit|Total hip bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.|Baseline (of extension study) and months 12, 24, 36, 60 and 84|"Participants with an Extension Study baseline and at least 1 post-baseline DXA BMD measurement. n indicates the number of participants with available data at each time point."||percent change||95% Confidence Interval|Least Squares Mean
746425|NCT00523341|Secondary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density by Visit|Lumbar spine bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.|Baseline (of extension study) and months 12, 24, 36, 60 and 84|"Participants with an Extension Study baseline and at least 1 post-baseline DXA BMD measurement. n indicates the number of participants with available data at each time point."||percent change||95% Confidence Interval|Least Squares Mean
746426|NCT00523341|Primary|Number of Participants With Antibodies to Denosumab||Every 12 months through Month 84|All participants who received at least 1 dose of denosumab||participants|||Number
746428|NCT00523341|Primary|Number of Participants With Adverse Events (AEs)|A serious adverse event (SAE) is defined as an adverse event that: • is fatal • is life threatening • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • is other significant medical hazard. Treatment-related adverse events includes only events for which the investigator indicated there was a reasonable possibility they may have been caused by study drug. The following were classified as adverse events of interest (events that are considered to be identified or potential risks of denosumab treatment): positively adjudicated osteonecrosis of the jaw, positively adjudicated atypical femoral fracture, hypocalcemia, adverse events potentially related to hypersensitivity, serious infection (including bacterial cellulitis), malignancy, cardiac disorders, vascular disorders, fracture healing complications, eczema, acute pancreatitis, and musculoskeletal pain.|84 months|All participants who received at least one dose of denosumab.||participants|||Number
746429|NCT00523367|Secondary|COPD/GERD Patients Treated With High Dose Esomeprazole|COPD patients with GERD treated with high dose esomeprazole for 1 year decreases the frequency of COPD exacerbations compared to the previous year without treatment.|1 year||||||
746430|NCT00523367|Primary|Number of Participants With Gastro Esophageal Reflux Disease One Year After Treatment.|The number of participants who have Gastro Esophageal Reflux Disease after one year of treatment.|1 year|||participants|||Number
746431|NCT00523419|Secondary|Overall Survival (OS) Time|OS was the duration from enrollment to death. For participants who lived, OS was censored at the last contact.|Baseline to 27.6 months|Full analysis population: all participants who were treated with at least one dose of the study regimen.||months||95% Confidence Interval|Median
746432|NCT00523419|Secondary|Progression-Free Survival (PFS)|PFS was from date of study enrollment to first date of objectively determined progressive disease (PD) or death from any cause. For participants who did not die as of data cut-off date and who did not have objective PD, PFS was censored at date of last objective progression-free disease assessment. For participants who received subsequent systemic anticancer therapy (after discontinuation from study drug) before objectively determined disease progression or death, PFS was censored at date of last objective progression-free disease assessment, before post-discontinuation chemotherapy.|Baseline to 10.4 months|Full analysis population: all participants who were treated with at least one dose of the study regimen.||months||95% Confidence Interval|Median
746433|NCT00523419|Secondary|Duration of Response|The duration of a complete response (CR) or partial response (PR) was defined as the time from the first objective status assessment of CR or PR to the first date of progression or death as a result of any cause: CR was achieved if all tumor lesions disappeared; PR was achieved if there was >=30% decrease in sum of the longest diameter (LD) of target lesions (reference: baseline sum LDs) or complete disappearance of target lesions with persistence (but not worsening) of >=1 nontarget lesions and no appearance of new lesions.|Baseline to 31 months|Tumor response population: participants with best overall response of complete response (CR) and partial response (PR).||months|||Number
746434|NCT00523419|Secondary|Number of Participants With Adverse Events (Pharmacology Toxicity)|Pharmacology toxicity was defined as serious and non-serious adverse events. Summaries of these adverse events are located in the Reported Adverse Event Section.|Baseline to 21 months|Full analysis population: all participants who were treated with at least one dose of the study regimen||participants|||Number
746435|NCT00523419|Secondary|Correlation of Disease Outcome With Pharmacogenomic Analysis|It was planned to examine methylthioadenosine phosphorylase (MTAP) gene deletion, folate receptor alpha (FRα) and folylpoly-gamma-glutamate synthetase (FPGS) expression, and to correlate the results with the clinical data to determine the association between these factors and clinical outcome to treatment. However, due to the small number of participants with partial response (n=1), the planned statistical analyses that would correlate responders/non responders with pharmacogenomics data are no longer valid and the analyses were not conducted.|Baseline to 21 months|Since this outcome measure was not analyzed due to the inadequate number of responders, zero participants were analyzed.||correlation coefficient|||Number
746436|NCT00523419|Secondary|Time to Treatment Failure|When the protocol was written, time to treatment failure (TTTF) was included as a secondary endpoint. However, it was subsequently realized that due to the design of the study, participants are treated until disease progression or discontinuation from study treatment, not for a fixed number of cycles. Therefore, it was concluded that analysis of TTTF was inappropriate with the current study design and the analysis was not conducted, since it would be essentially the same as Progression-Free Survival.|Baseline to 21 months|Since this outcome measure was not analyzed due to the study design, zero participants were analyzed.||days||Standard Deviation|Mean
746437|NCT00523419|Primary|Percentage of Participants With Tumor Response|Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR) = disappearance of all target lesions; Partial Response (PR) = at least a 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD) = at least a 20% increase in sum of longest diameter of target lesions; Stable Disease (SD) = small changes that do not meet above criteria. Tumor Response Rate(%) = sum of number of PR + CR observed/number of participants qualified for tumor response analysis * 100.|Baseline to 21 months|Participants who qualified for tumor response analysis are those with histological evidence of high grade locally advanced or metastatic osteosarcoma and treatment with at least 1 dose of study drug. Three participants died before the first tumor assessment and 1 participant discontinued without any tumor assessments and were considered Unknown.||percentage of participants||95% Confidence Interval|Number
746438|NCT00523549|Secondary|Change in Estimated Central Aortic Pressure|Change from baseline in estimated central aortic pressure at Weeks 8 and 24|Baseline to 8 and 24 weeks after treatment|Intent-to-treat||mm Hg||Standard Deviation|Mean
746439|NCT00523549|Secondary|Change in Mean Sitting Diastolic Blood Pressure (msDBP)|Change from baseline in msDBP at Weeks 8 and 24|Baseline to 8 and 24 weeks after treatment|Intent-to-treat population||mm Hg||Standard Deviation|Mean
746440|NCT00523549|Secondary|Change in Mean Sitting Systolic Blood Pressure (msSBP)|Change from baseline in msSBP at Weeks 8 and 24|Baseline to 8 and 24 weeks after treatment|Intent-to-treat||mm Hg||Standard Deviation|Mean
746441|NCT00523549|Secondary|Percent Change From Baseline in Vascular Stiffness|Percent change from baseline in Vascular Stiffness (measured by radial augmentation index [AI]) at Weeks 8 and 24|Baseline to 8 and 24 weeks after treatment|Intent-to-treat||percentage of change in mean AI||Standard Deviation|Mean
746445|NCT00523614|Primary|Risk of Venous Thromboembolism (VTE) Between Women Who Use Dienogest/Ethinylestradiol (DNG/EE) and Women Who Use Other Low-dose Combined Oral Contraceptives (COC)|The time frame is the time when venous thromboembolism (VTE) was diagnosed in the cases group. VTE includes deep venous thrombosis and pulmonary embolism. These clinical endpoints were established by magnetic resonance imaging, spiral computer tomography, duplex sonography, and lung scintigraphy.|01/2002 - 01/2008|||Participants|||Number
746446|NCT00523640|Secondary|Overall Survival|Time from enrollment until death from any cause.|60 months|||months||95% Confidence Interval|Median
746447|NCT00523640|Primary|Progression-free Survival|Progression is defined as a measurable increase in the sum of longest diameters of all target lesions, or unequivocable progression of non-target lesions, or the appearance of new lesions, since baseline|60 months|||months||95% Confidence Interval|Median
746448|NCT00523640|Primary|Objective Response Rate|Per RECIST Criteria (V1.0) using standard cross-sectional CT scanning: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Response (R)= CR + PR.|12 weeks|||proportion|||Number
746449|NCT00523705|Secondary|Subject Satisfaction Questionnaire||Study endpoint|Not analyzed due to small number of subjects.|||||
746450|NCT00523705|Secondary|Patient Global Evaluation of Improvement (PGE)||Throughout treatment|Not analyzed due to small number of subjects|||||
746451|NCT00523705|Secondary|Sheehan Disability Scale (SDS)||Throughout study|Data not analyzed due to only 11 subjects.|||||
746452|NCT00523705|Primary|Subject Daily Symptom Rating Score.|A daily diary with 17 symptoms of PMS rated on a 5-point scale to indicate none to very severe symptoms. Minimum score 0; maximum score 408.|baseline and 5 months.|||units on a scale||Standard Deviation|Mean
746453|NCT00523718|Secondary|Clinical Global Impression (CGI) - Severity of Illness Item|The Clinical Global Impression – Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.|14 weeks|||units on a scale||Standard Deviation|Mean
746454|NCT00523718|Secondary|Average Hamilton Anxiety Inventory (HAM-A)|The Hamilton Anxiety Rating Scale (HARS or HAM-A) is a psychological questionnaire used by clinicians to rate the severity of a patient's anxiety. Total score ranges from 0 to 56. A score of 17 or less indicates mild anxiety severity. A score from 18 to 24 indicates mild to moderate anxiety severity. A score of 25 to 30 indicates a moderate to severe anxiety severity. A score of 31 or greater represents very severe anxiety severity.|14 weeks|||units on a scale||Standard Deviation|Mean
746455|NCT00523718|Secondary|Average Hamilton Depression Inventory (HAM-D)|"The HDRS (also known as the HAM-D) is the most widely used clinician-administered depression assessment scale. The HAM-D 17-item scale ranges from 0 (normal) to >23 (very severe depression), with a maximum score of 52. The 24-item scale has a maximum score of 75. Severity of depression (e.g. normal or very severe) is based upon the score in the first 17-items."|14 weeks|||units on a scale||Standard Deviation|Mean
746456|NCT00523718|Primary|Partial Responders by Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)|"The Yale–Brown Obsessive Compulsive Scale (Y-BOCS) is a test to rate the severity of obsessive–compulsive disorder (OCD) symptoms. The scale is a clinician-rated, 10-item scale, each item rated from 0 (no symptoms) to 4 (extreme symptoms), yielding a total possible score range from 0 to 40. The results can be interpreted based on the total score:
0–7 is sub-clinical; 8–15 is mild; 16–23 is moderate; 24–31 is severe; 32–40 is extreme.
Improvement was defined apriori as a 25% improvement from baseline"|14 weeks|||participants|||Number
746457|NCT00523744|Secondary|Percentage of Patients Who Achieved a Protocol-defined Blood Pressure Response During the Extension Phase of the Study|Blood pressure response was defined as msSBP < 140 mmHg or a 20 mmHg decrease in msSBP at the end of Phase 3 compared to Baseline in Phase 3 or a msDBP < 90 mmHg or a 10 mmHg decrease in msDBP at the end of Phase 3 compared to Baseline in Phase 3.|Baseline of Phase 3 (Week 8) to end of Phase 3 (Week 12)|Safety population: All patients who took at least one dose of amlodipine 10 mg plus valsartan 160 mg plus HCTZ 12.5 mg.||Percentage of participants|||Number
746458|NCT00523744|Secondary|Percentage of Patients Who Achieved Normalized Blood Pressure During the Extension Phase of the Study|Normalized Blood Pressure was defined as a msSBP < 140 mmHg and/or a msDBP < 90 mmHg.|Baseline Phase 3 (Week 8) to end of Phase 3 (Week 12)|Safety population: All patients who took at least one dose of amlodipine 10 mg plus valsartan 160 mg plus HCTZ 12.5 mg.||Percentage of participants|||Number
746459|NCT00523744|Secondary|Change in Sitting Pulse Rate During the Extension Phase of the Study|Pulse rate was measured once for 30 seconds just prior to blood pressure measurements in the sitting position.|Baseline Phase 3 (Week 8) to end of Phase 3 (week 12)|Safety population: All patients who took at least one dose of amlodipine 10 mg plus valsartan 160 mg plus HCTZ 12.5 mg.||BPM (beats per minute)||95% Confidence Interval|Mean
746460|NCT00523744|Secondary|Change in Sitting Pulse Pressure During the Extension Phase of the Study|Pulse pressure is systolic pressure (SP) minus diastolic pressure (DP). The arm in which the highest sitting DPs were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, SP and DP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.|Baseline Phase 3 (Week 8) to end of Phase 3 (Week 12)|Safety population: All patients who took at least one dose of amlodipine 10 mg plus valsartan 160 mg plus HCTZ 12.5 mg.||mmHg||95% Confidence Interval|Mean
746472|NCT00517361|Secondary|Correlation of Response to BRCA1 Methylation Status|The methylation status of the tumor is defined using Methylation Specific polymerase chain reaction and/or pyrosequencing.|Up to 5 years|This study has been terminated due to poor accrual.|||||
746473|NCT00517361|Secondary|Duration of Response||Up to 5 years|This study has been terminated due to poor accrual.|||||
746545|NCT00517829|Secondary|Overall Survival|OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.|Treatment will continue until disease progression or intolerable toxicity|ITT population||months||95% Confidence Interval|Median
746461|NCT00523744|Secondary|Change in Mean Sitting Systolic Blood Pressure (msSBP) During the Extension Phase of the Study|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.|Baseline Phase 3 (Week 8) to end of Phase 3 (Week 12)|Safety population: All patients who took at least one dose of amlodipine 10 mg plus valsartan 160 mg plus HCTZ 12.5 mg.||mmHg||95% Confidence Interval|Mean
746462|NCT00523744|Secondary|Percentage of Patients Who Achieved a Protocol-defined Blood Pressure Response During the Core Phase of the Study|Blood pressure response was defined as msSBP < 140 mmHg or a 20 mmHg decrease in msSBP at the end of Phase 2 (Week 8) compared to Baseline in Phase 2 (week 4) or a msDBP < 90 mmHg or a 10 mmHg decrease in msDBP at the end of Phase 2 compared to Baseline in Phase 2.|Baseline of Phase 2 (Week 4) to end of Phase 2 (Week 8)|Intent-to-treat population (ITT): All patients who took at least one dose of amlodipine plus valsartan who had at least one primary efficacy parameter evaluation. Patients who dropped out were included in the ITT population if there was any BP measurement available; their last available blood pressure measurement was used for the analysis.||Percentage of participants|||Number
746463|NCT00523744|Secondary|Percentage of Patients Who Achieved Normalized Blood Pressure During the Core Phase of the Study|Normalized Blood Pressure was defined as a msSBP < 140 mmHg and/or a msDBP < 90 mmHg.|Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8)|Intent-to-treat population (ITT): All patients who took at least one dose of amlodipine plus valsartan who had at least one primary efficacy parameter evaluation. Patients who dropped out were included in the ITT population if there was any BP measurement available; their last available blood pressure measurement was used for the analysis.||Percentage of participants|||Number
746464|NCT00523744|Primary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) During the Extension Phase of the Study|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.|Baseline Phase 3 (Week 8) to end of Phase 3 (Week 12)|Safety population: All patients who took at least one dose of amlodipine 10 mg plus valsartan 160 mg plus HCTZ 12.5 mg.||mmHg||95% Confidence Interval|Mean
746465|NCT00523744|Secondary|Change in Sitting Pulse Rate During the Core Phase of the Study|Pulse rate was measured once for 30 seconds just prior to blood pressure measurements in the sitting position.|Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8)|Intent-to-treat population (ITT): All patients who took at least one dose of amlodipine plus valsartan who had at least one primary efficacy parameter evaluation. Patients who dropped out were included in the ITT population if there was any BP measurement available; their last available blood pressure measurement was used for the analysis.||BPM (beats per minute)||95% Confidence Interval|Mean
746466|NCT00523744|Secondary|Change in Sitting Pulse Pressure During the Core Phase of the Study|Pulse pressure is systolic pressure (SP) minus diastolic pressure (DP). The arm in which the highest sitting DPs were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, SP and DP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.|Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8)|Intent-to-treat population (ITT): All patients who took at least one dose of amlodipine plus valsartan who had at least one primary efficacy parameter evaluation. Patients who dropped out were included in the ITT population if there was any BP measurement available; their last available blood pressure measurement was used for the analysis.||mmHg||95% Confidence Interval|Mean
746467|NCT00523744|Secondary|Change in Mean Sitting Systolic Blood Pressure (msSBP) During the Core Phase of the Study|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.|Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8)|Intent-to-treat population (ITT): All patients who took at least one dose of amlodipine plus valsartan who had at least one primary efficacy parameter evaluation. Patients who dropped out were included in the ITT population if there was any BP measurement available; their last available blood pressure measurement was used for the analysis.||mmHg||95% Confidence Interval|Mean
746468|NCT00523744|Primary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) During the Core Phase of the Study|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.|Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8)|Intent-to-treat population (ITT): All patients who took at least one dose of amlodipine plus valsartan who had at least one primary efficacy parameter evaluation. Patients who dropped out were included in the ITT population if there was any BP measurement available; their last available blood pressure measurement was used for the analysis.||mmHg||95% Confidence Interval|Mean
746469|NCT00517296|Secondary|Changes in Perianal Disease Activity Index (PDAI)|Changes in Crohn's disease activity at Week 48 compared to baseline based on PDAI Scores- higher numbers equal more significant disease activity. PDAI has a range from 0 to 20.|Baseline and 48 Weeks|||units on a scale||Inter-Quartile Range|Mean
756036|NCT00591344|Secondary|50 ft Walk Time|Time it takes to walk 50 feet|Obtained during initial evaluation & then every 6 six months to end of 2-yr training period||||||
746474|NCT00517361|Secondary|Response Rate|Response is defined using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000]: Complete Response (CR), Disappearance of all target lesions or disappearance of all non-target lesions and normalization of tumor marker level; Partial Response (PR), At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD since the treatment started, or persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits.|Up to 5 years|This study has been terminated due to poor accrual.|||||
746475|NCT00517361|Primary|Progression Free Survival|Progression is defined using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000], as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions, or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|Up to 5 years|This study has been terminated due to poor accrual.|||||
746476|NCT00517413|Secondary|Mean Ferritin Levels Over Time|Ferritin is a protein found inside cells that stores iron so that the body can use it later. A ferritin test indirectly measures the amount of iron in your blood. The Ferritin levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The standard reference ranges for ferritin are as follows: Female: min-max for lower limit=6 - 50 mcg/L and min-max for upper limit=120 - 400 mcg/L; Male: min-max for lower limit=10 - 50 mcg/L and min-max for upper limit=200 - 400 mcg/L.|Baseline (Week 0), Week 8, 16, 24, 32, 40, and 48|The safety population included all participants who entered into the study. n = the number of participants analyzed at a given time point.||mcg/L||Standard Deviation|Mean
746477|NCT00517413|Secondary|Mean C-Reactive Protein Levels Over Time|C-reactive protein (CRP) is produced by the liver. The level of CRP rises when there is inflammation throughout the body. The CRP test is a general test to check for inflammation in the body.The CRP levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The standard reference ranges for CRP are as follows: Female/Male: min-max for lower limit=0 - 10 mg/L and min-max for upper limit=0.5 - 30 mg/L.|Baseline (Week 0), 8, 16, 24, 32, 40, and 48|The safety population included all participants who entered into the study. n = the number of participants analyzed at a given time point.||mg/L||Standard Deviation|Mean
746478|NCT00517413|Secondary|Mean Albumin and Transferrin Levels Over Time|The albumin and transferrin levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The standard reference ranges for albumin are as follows: Female/Male: min-max for lower limit=30 - 35 g/L and min-max for upper limit=48 – 55 g/L. The standard reference ranges for transferrin are as follows: Female/Male: min-max for lower limit=1.5 - 2.3 g/L and min-max for upper limit=2.87 - 4.3 g/L.|Baseline (Week 0), Week 8, 16, 24, 32, 40, and 48|The safety population included all participants who entered into the study.||g/L||Standard Deviation|Mean
746479|NCT00517413|Secondary|Mean Transferrin Saturation Levels Over Time|Transferrin saturation (TSAT) is the ratio of serum iron and total iron-binding capacity. Transferrin is a blood protein that picks up iron absorbed by the intestines and transports it from one location to another. When iron absorption is abnormally high, transferrin proteins become more saturated with iron. An elevated TS value therefore reflects an increase in iron absorption. The TSAT levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. TSAT was calculated automatically in the electronic case report form (eCRF) according to the following formulae: TSAT= (Serum Iron*100)/(Transferrin*1.41) or TSAT=(Serum Iron*100)/TIBC. Calculated data was not provided by laboratory; therefore no reference range is available.|Baseline (Week 0), Week 8, 16, 24, 32, 40, and 48|The safety population included all participants who entered into the study. n = the number of participants analyzed at a given time point.||Percentage of Transferrin Saturation||Standard Deviation|Mean
746480|NCT00517413|Secondary|Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time|The creatinine, iron, and total iron binding capacity (TIBC) levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The standard reference ranges for creatinine are as follows: Female: min-max for lower limit=0 - 70.72 mmol/L and min-max for upper limit=79.56 - 123.76 mmol/L; Male: min-max for lower limit=0 - 70.72 mmol/L and min-max for upper limit=97.24 - 123.76 mmol/L. The standard reference ranges for iron are as follows: Female: min-max for lower limit=6.265 - 10.74 mmol/L and min-max for upper limit=25.06 - 32.22 mmol/L and Male: min-max for lower limit=6.265 - 11.635 mmol/L and min-max for upper limit=25.06 - 32.22 mmol/L. The standard reference ranges for TIBC are as follows: Female: min-max for lower limit=19.69 - 49.046 mmol/L and min-max for upper limit=62.65 - 88.963 mmol/L and Male: min-max for lower limit=19.69 - 52.089 mmol/L and min-max for upper limit=62.65 - 80.55 mmol/L.|Baseline (Week 0), Week 8, 16, 24, 32, 40, and 48|The safety population included all participants who entered into the study. n = the number of participants analyzed at a given time point.||μmol/L||Standard Deviation|Mean
746481|NCT00517413|Secondary|Mean Phosphate and Potassium Levels Over Time|The phosphate and potassium levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The standard reference ranges for phosphate are as follows: Female/Male: min-max for lower limit= 0.48435 - 0.9687 mmol/L and min-max for upper limit=1.45305 - 2.2603 mmol/L. The standard reference ranges for potassium are as follows: Female/Male: min-max for lower limit=3.1 - 3.7 mmol/L and min-max for upper limit=5 - 5.5 mmol/L.|Baseline (Week 0), Week 8, 16, 24, 32, 40, and 48|The safety population included all participants who entered into the study. n = the number of participants analyzed at a given time point.||mmol/L||Standard Deviation|Mean
746482|NCT00517413|Secondary|Mean White Blood Cells and Thrombocyte Levels Over Time|The white blood cells (WBC) and thrombocyte levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The standard reference ranges for WBC are as follows: Female/Male: min-max for lower limit= 3.5 - 5*10^9 cells/L and min-max of upper limit= 9 -13.5*10^9 cells/L. The standard reference ranges for thrombocyte are as follows: Female/Male: min-max for lower limit= 130 – 150*10^9 cells/L and min-max of upper limit= 300 - 450*10^9 cells/L.|Baseline (Week 0), Week 8, 16, 24, 32, 40, and 48|The safety population included all participants who entered into the study. n = the number of participants analyzed at a given time point.||10^9 cells/L||Standard Deviation|Mean
746483|NCT00517413|Secondary|Mean Hematocrit Levels Over Time|The haematocrit (HCT) levels in fraction were recorded for each participant at enrollment and at different time points during the study up to Week 48. The standard reference range for hematocrit are as follows: Female: min-max for lower limit=0.12 - 0.38 and min-max of upper limit=0.43 - 0.537; Male: min-max for lower limit=0.35 - 0.45 and min-max of upper limit=0.45 - 0.54.|Baseline (Week 0), Week 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48|The safety population included all participants who entered into the study. n = the number of participants analyzed at a given time point.||Proportion of red blood cells in blood||Standard Deviation|Mean
746484|NCT00517413|Secondary|Mean Haemoglobin Levels Over Time|The Hb levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The standard reference range for Hb are as follows: Female: min-max for lower limit=11 to 13 g/dL and min-max for upper limit=14 to 18.1 g/dL; Male: min-max for lower limit=12 to 14.2 g/dL and min-max for upper limit=16 to 18.1 g/dL.|Baseline (Week 0), Week 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48|The safety population included all participants who entered into the study. n = the number of participants analyzed at a given time point.||g/dL||Standard Deviation|Mean
746485|NCT00517413|Secondary|Number of Participants With Adverse Events and Serious Adverse Events|Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.|Up to Week 52|The safety population included all participants who entered into the study.||participants|||Number
746486|NCT00517413|Secondary|Incidence of Red Blood Cell Transfusions During the C.E.R.A. Treatment Phase|Red blood cell (RBC) transfusions were permitted during the treatment period in case of medical need. The pre-transfusion Hb level was measured before any transfusion was administered.|Baseline (Week 0) to Week 44|The safety population included all participants who entered into the study.||participants|||Number
746487|NCT00517413|Secondary|Mean Monthly Dose of C.E.R.A During the DTP and EEP|The initial dose of C.E.R.A. was 120, 200, or 360 mcg IV or SC every 4 weeks for 48 weeks, which was based on the last dose of the previous ESA. Dose adjustments were necessary when Hb increased or decreased by a clinically significant amount. The dose of C.E.R.A. was adjusted to maintain the individual participant's Hb within a range of +/-1.0 g/dL of the reference Hb concentration and between 10.5 and 12.5 g/dL throughout the DTP and the EEP. The reference Hb value was taken as the mean of all Hb assessments during the stability verification period. The mean monthly doses of C.E.R.A during the DTP and EEP are presented.|Baseline (Week 0) to Week 24|The Intention To Treat (ITT) population included participants who received at least 1 dose of C.E.R.A. (Week 0) and for whom data for at least one follow-up variable were available.||mcg||Standard Deviation|Mean
746488|NCT00517413|Secondary|Percentage of Participants Requiring Dose Adjustments of C.E.R.A During the DTP and EEP|Dose adjustments were necessary when Hb increased or decreased by a clinically significant amount. The dose of C.E.R.A. was adjusted to maintain the individual participant’s Hb within a range of +/-1.0 g/dL of the reference Hb concentration and between 10.5 and 12.5 g/dL throughout the DTP (Week 0 to Week 16) and the EEP (Weeks 16 to 24). The reference Hb value was taken as the mean of all Hb assessments during the stability verification period (Weeks -4, -3, -2, -1). The percentage of participants requiring C.E.R.A dose adjustments during the DTP and EEP are presented.|Baseline (Week 0) to Week 24|The Intention To Treat (ITT) population included participants who received at least 1 dose of C.E.R.A. (Week 0) and for whom data for at least one follow-up variable were available.||Percentage of participants|||Number
746489|NCT00517413|Secondary|Mean C.E.R.A Dose To Maintain Hb Level Within the Range 10.5-12.5 g/dL Throughout the EEP|The Hb levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The mean C.E.R.A dose required to maintain the Hb level within the range 10.5-12.5 g/dL throughout the EEP is presented.|EEP (Week 16 to 24)|The Intention To Treat (ITT) population included participants who received at least 1 dose of C.E.R.A. (Week 0) and for whom data for at least one follow-up variable were available.||mcg||Standard Deviation|Mean
746490|NCT00517413|Secondary|Mean Time Spent by the Participants in the Hb Target Range 10.5-12.5 g/dL During EEP|The Hb levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The mean time (days) spent by the participants in the Hb target range 10.5 to 12.5 is reported.|EEP (Week 16 to 24)|The Intention To Treat (ITT) population included participants who received at least 1 dose of C.E.R.A. (Week 0) and for whom data for at least one follow-up variable were available.||days||Standard Deviation|Mean
746491|NCT00517413|Secondary|Percentage of Participants Maintaining Hb Concentration Within The Target Range 10.5 and 12.5 g/dL Throughout the EEP|The Hb levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The percentage of participants maintaining their mean Hb concentration within the target range 10.5 and 12.5 g/dL throughout the EEP are reported.|EEP (Week 16 to 24)|The Intention To Treat (ITT) population included participants who received at least 1 dose of C.E.R.A. (Week 0) and for whom data for at least one follow-up variable were available.||Percentage of participants||95% Confidence Interval|Number
746492|NCT00517413|Secondary|Mean Change in the Hb Concentration Between the Stability Verification Period and the EEP|The Hb levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The mean change in the Hb concentration between the Stability Verification Period (SVP) and the EEP is reported.|SVP (Week -4 to -1), EEP (Week 16 to 24)|The Intention To Treat (ITT) population included participants who received at least 1 dose of C.E.R.A. (Week 0) and for whom data for at least one follow-up variable were available.||g/dL||Standard Deviation|Mean
746503|NCT00517530|Secondary|Percentage of Participants With Complete Response (CR/CRu/CRi) in Phase II of the Study|A complete response was defined as the disappearance of all evidence of disease (NHL) and symptoms; normalization of biochemical abnormalities (NHL); regression of lymph nodes and nodal masses to normal size; decrease of nodes in the sum of the products of the greatest diameters (SPD); regression in size of the spleen and/or liver, should not be palpable, and disappearance of nodules related to lymphoma (CLL). Complete/unconfirmed (CRu) response includes NHL patients with one or more of the following: 1) a residual lymph node mass greater than 1.5 cm in greatest transverse diameter that has regressed by more than 75% in the SPD; 2) Indeterminate bone marrow (increased number or size of aggregates without cytologic or architectural atypia). Complete Response with Incomplete Bone Marrow Recovery (CRi) was measured only in patients with CLL.|by Cutoff Date: 31 March 2012 (within 3 years, 4 months)|||percentage of participants|||Number
786244|NCT00839241|Primary|Frequency of Natural Killer Cells as Measured With Flow Cytometry.||Day 5 postop|||total number of cells * 10^5/mL||Standard Deviation|Mean
746493|NCT00517413|Primary|Percentage of Participants Maintaining Their Mean Hb Concentration Within ±1.0 Gram/Deciliter of Their Reference Hb and Between 10.5 and 12.5 Gram/Deciliter|The haemoglobin (Hb) levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The reference Hb value was defined on the basis of individual participant’s all assessments at Weeks -4, -3, -2, -1 and 0. The Hb value on the first day of first dose (Week 0) was included in the calculation, as this assessment was performed before the first dose was given. The percentage of participants maintaining their mean Hb concentration within +/-1.0 gram/deciliter (g/dL) of their reference Hb and between 10.5 and 12.5 g/dL are reported for efficacy evaluation period (EEP). Efficacy evaluation period was from Week 16 to Week 24 after completion of 16-week dose titration period (DTP).|EEP (Week 16 to 24)|The Per-Protocol Population (PP) included all participants in the safety population except those who had <3 recorded Hb values; withdrawn; inadequate iron defined as mean serum ferritin =<100 nanogram/milliliter (ng/mL) or mean TSAT=<20% or mean hypochromic RBCs>=10%; or had missing administration of C.E.R.A. all during EEP (Week 16-24).||Percentage of participants||95% Confidence Interval|Number
746494|NCT00517530|Other Pre-specified|Maximum Plasma Concentration (Cmax) of Obinutuzumab in CLL Patients||at Cycle 1 Day 1, Cycle 1 Day 8 and Cycle 8 (over 168 days)|||micrograms/mL||Geometric Coefficient of Variation|Geometric Mean
746495|NCT00517530|Secondary|Area Under the Concentration-time Curve of Obinutuzumab Administered on Day 1 of Cycle 1 in Phase I of the Study|Blood samples were taken on Day 1 (pre-infusion, end of infusion, 3-6 hours post-infusion) of Cycle 1. Nonlinear mixed-effects modeling (with NONMEM software) was used to analyze the pooled samples for dose-concentration-time data of obinutuzumab.|Day 1 of Cycle 1|Pharmacokinetics (PK)- evaluable population at the given dose (e.g., 3 or more participants). Other doses did not have a PK-evaluable population, so were not included in the table of results. Due to the limited sampling schedule derived PK parameters could not be accurately obtained during Cycle 1 and Cycle 8.||µm/ml*day||Geometric Coefficient of Variation|Geometric Mean
746496|NCT00517530|Secondary|Maximum Plasma Concentration (Cmax) of Obinutuzumab in NHL Participants|Obinutuzumab serum pharmacokinetic (PK) parameters in NHL participants following ascending doses.|at Cycle 1 Day 1, Cycle 1 Day 8 and Cycle 8 (over 168 days)|Pharmacokinetics (PK)- evaluable population at the given dose (e.g., 3 or more participants at any of the given time points). Other doses did not have a PK-evaluable population, so were not included in the table of results. Due to the limited sampling schedule derived PK parameters could not be accurately obtained during Cycle 1 and Cycle 8.||µm/ml*day||Geometric Coefficient of Variation|Geometric Mean
746497|NCT00517530|Secondary|Percentage of Retreated Participants With Response|Patients who might benefit from retreatment were allowed to be treated again at the request of the investigator.|by Cutoff Date: 25 November 2013 (within 4 years, 2 months)|Retreated participants||percentage of participants|||Number
746498|NCT00517530|Secondary|Pharmacodynamics: Participants With Peripheral B-cell Recovery After Having Had Depletion at End of Treatment During Phase II of the Study|B-cell depletion was defined in two ways: definition 1 – decrease below 5% baseline level and definition 2 – decrease below 0.04 x 109/L. B-cell recovery was defined in two ways: definition 1 – return to at least 50% of baseline level and definition 2 – return to at least 0.08 x 109/L.|by the end of Phase II (within 3 years, 4 months)|Participants analyzed include those with B-cell depletion at the end of treatment (N), with assessments (n) at each time point.||participants|||Number
746499|NCT00517530|Secondary|Participants With Event-Free Survival (EFS) in Phase II of the Study|EFS is defined as the time from start of treatment to disease progression/relapse, death or, in case of early withdrawal from the treatment period, the (end) date of last dose, whatever comes first.|by the end of the follow-up period in Phase II of the study (within 3 years, 4 months)|||participants|||Number
746500|NCT00517530|Secondary|Duration of Response by Disease Type in Phase II of the Study|Duration of complete response was defined as the time from the first complete or partial response until disease progression (PD) or death, whichever occurred first. For non-Hodgkin’s lymphoma participants, PD was defined as >= 50% increase from nadir in the sum of the products of the greatest diameters (SPD) of any previously identified abnormal node for participants with a partial response or non-responders or the appearance of any new lesion during or at the end of therapy. For chronic lymphocytic leukemia participants, PD was defined as: (1) A >= 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or the size of other lesions (eg, splenic or hepatic nodules); a lymph node with a short axis of < 1.0 cm must increase by >= 50% and to a size of 1.5×1.5 cm or > 1.5 cm in the longest axis. (2) Appearance of any new lesion > 1 cm in the short axis. (4) A new site that is PET-positive with histological confirmation.|by the end of the follow-up period in Phase II of the study (within 3 years, 4 months)|Safety population: All enrolled participants in Phase II, who had received at least 1 dose of obinutuzumab. Data reported for each disease cohort.||days||Full Range|Median
746501|NCT00517530|Secondary|Progression-free Survival (PFS) in Phase II of the Study|PFS was defined as the time from start of treatment to disease progression (PD) or death due to any cause, whichever occurred first. For non-Hodgkin’s lymphoma participants, PD was defined as >= 50% increase from nadir in the sum of the products of the greatest diameters (SPD) of any previously identified abnormal node for participants with a partial response or non-responders or the appearance of any new lesion during or at the end of therapy. For chronic lymphocytic leukemia participants, PD was defined as: (1) A >= 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or the size of other lesions (eg, splenic or hepatic nodules); a lymph node with a short axis of < 1.0 cm must increase by >= 50% and to a size of 1.5×1.5 cm or > 1.5 cm in the longest axis. (2) Appearance of any new lesion > 1 cm in the short axis. (4) A new site that is positron emission tomography (PET)-positive with histological confirmation.|by the end of the follow-up period in Phase II of the study (within 3 years, 4 months)|Safety population: All enrolled participants in Phase II, who had received at least 1 dose of obinutuzumab.||days||95% Confidence Interval|Median
746502|NCT00517530|Secondary|Percentage of Participants With Partial Response (PR) in Phase II of the Study|A PR was defined as a >=50% decrease in SPD of the 6 largest nodes or nodal masses; no increase in size of other nodes, liver, or spleen; regression of splenic and hepatic nodules by >=50% in their SPD or, for single nodules, in the long axis (CLL only); and no new disease sites.|by Cutoff Date: 31 March 2012 (within 3 years, 4 months)|||percentage of participants|||Number
747589|NCT00530842|Secondary|Static Lung Volumes (Percent)|Post-dose RV/TLC (Residual Volume over Total Lung Capacity) after 8 weeks (measured by bodyphlethysmography)|8 weeks|FAS using imputed values||Percent of RV over TLC||Standard Error|Mean
746504|NCT00517530|Primary|Percentage of Participants With Best Overall Response in Phase II of the Study|Best overall response (BOR) was defined as the percentage of participants with a complete response (CR) or partial response (PR)|by Cutoff Date: 31 March 2012 (within 3 years, 4 months)|Safety population: All enrolled participants in Phase II, who had received at least 1 dose of obinutuzumab.||percentage of participants|||Number
746505|NCT00517530|Primary|Percentage of Participants Who Experienced a Dose-limiting Toxicity in Phase I of the Study|Dose-limiting toxicities were defined as obinutuzumab-related adverse events occurring within the first 28 days of each administration of obinutuzumab, with the exception of B-cell depletion and lymphopenia which are expected outcomes of treatment with obinutuzumab.|Baseline to 28 days after the last infusion of obinutuzumab (up to 6 months)|Safety population: All enrolled participants in Phase I, who had received at least 1 dose of obinutuzumab by 6 months.||percentage of participants|||Number
746506|NCT00517556|Primary|Change in Visual Analog Scale (VAS) Score|Change in subjective perception of pain, as measured by the VAS. Subjects completed the VAS at baseline and 6 months. The VAS ranges from 0 (no pain) to 100 (worst pain). Therefore, a negative change in VAS indicates improvement in pain and a positive change in VAS indicates worsening of pain.|Baseline and 6 months|||units on a scale||95% Confidence Interval|Mean
746507|NCT00517595|Other Pre-specified|Overall Survival (OS) by Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status|Overall survival is defined as the time from treatment start until death from any cause. The median overall survival time is used to measure OS. ECOG performance status describes how daily living activities of the patient are affected by disease. ECOG of 0 means the patient is fully active without restriction. ECOG of 1 means the patient is restricted in physically strenuous activity but is able to carry out light work. The investigator assigned the ECOG score at baseline (i.e., before the patient started study treatment).|OS was measured from day 1 of treatment until time of death, assessed up to 20 months.|Note that N=18 patients for the Baseline ECOG performance status 0 group, and N=30 patients for the Baseline ECOG performance status 1 group.||Months||95% Confidence Interval|Median
746508|NCT00517595|Other Pre-specified|Progression Free Survival (PFS) by Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status|PFS is defined as the duration of time from start of treatment to time of progression or death, whichever comes first. The median progression free survival is the parameter used to describe PFS. ECOG performance status describes how daily living activities of the patient are affected by disease. ECOG of 0 means the patient is fully active without restriction. ECOG of 1 means the patient is restricted in physically strenuous activity but is able to carry out light work. The investigator assigned the ECOG score at baseline (i.e., before the patient started study treatment).|PFS was measured from day 1 of treatment until time of progression (assessed every 8 weeks) or death, whichever came first, assessed up to 15 months.|Note that N=18 patients for the Baseline ECOG performance status 0 group, and N=30 patients for the Baseline ECOG performance status 1 group.||Months||95% Confidence Interval|Median
746509|NCT00517595|Secondary|Overall Response|Response was evaluated via changes from baseline in radiological tumor measurements performed after every 4th treatment cycle and at the end of treatment or time of progression. Response was evaluated using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD) is neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of >=20%; Progressive Disease (PD) is the increase in existing lesions or new lesions.|Response to treatment was assessed after every 8 weeks of treatment, up to 50 weeks.|||Participants|||Number
746510|NCT00517595|Secondary|Overall Survival (OS)|Overall survival is defined as the time from treatment start until death from any cause. The median overall survival time is used to measure OS.|OS was measured from day 1 of treatment until time of death, assessed up to 20 months.|||Months||95% Confidence Interval|Median
746511|NCT00517595|Secondary|Time to Progression (TTP)|Time to progression is defined as the time from treatment start until objective tumor progression. Progression is defined per RECIST criteria v1.0 as a measurable increase in the smallest diameter of any target lesion, progression of existing non-target lesions, or the appearance of 1 or more new lesions. The median time to progression is the parameter used to describe TTP.|TTP was measured from day 1 of treatment until time of progression (assessed every 8 weeks), assessed up to 15 months.|||Months||95% Confidence Interval|Median
746512|NCT00517595|Primary|Progression Free Survival (PFS)|PFS is defined as the duration of time from start of treatment to time of progression or death, whichever comes first. Progression is defined per RECIST criteria v1.0 as a measurable increase in the smallest diameter of any target lesion, progression of existing non-target lesions, or the appearance of 1 or more new lesions. The median progression free survival is the parameter used to describe PFS.|PFS was measured from day 1 of treatment until time of progression (assessed every 8 weeks) or death, whichever came first, assessed up to 15 months.|||Months||95% Confidence Interval|Median
746513|NCT00517634|Secondary|Weighted Mean Change From Baseline Over 0-6 Hours in Serum IL-5 Post-Allergen Challenge on Day 14|Amount of serum IL-5 measured from blood draws|0-6 hours post allergen challenge, 1 hour after dosing, Day 14||||||
746514|NCT00517634|Secondary|Weighted Mean Change From Baseline Over 0-6 Hours in Serum IL-5 Post-Allergen Challenge on Day 35|Amount of serum interleukin (IL)-5 measured from blood draws|0-6 hours post allergen challenge, 10-11 hours post treatment, Day 35||||||
746515|NCT00517634|Secondary|Weighted Mean Change From Baseline Over 0-6 Hours in Blood Eosinophils Post-Allergen Challenge on Day 14|Number of peripheral blood eosinophils measured from blood draws|0-6 hours, post allergen challenge, 1 hour post treatment, Day 14|ITT Population||Giga Units per Liter (GI/L)||95% Confidence Interval|Mean
746516|NCT00517634|Primary|Weighted Mean Change From Baseline Over 0-6 Hours in Blood Eosinophils Post-Allergen Challenge on Day 35|Number of peripheral blood eosinophils measured from blood draws|0-6 hours post allergen challenge, 10-11 hours post treatment, Day 35|Intent-to-Treat (ITT) Population: All participants receiving at least one dose of study medication who had at least one post-randomization efficacy assessment||Giga Units per Liter (GI/L)||95% Confidence Interval|Mean
746532|NCT00517751|Secondary|Patient Satisfaction (PS) Scores Measured by Zurich Claudication Questionnaire (ZCQ) at Post Treatment|PS score is the mean score of 6 questions of ZCQ, ranging from 1 to 4 if the number of responses exceeded four. A lower score represents a better outcome. Patients with PS score less than 2.5 at postoperative evaluation were considered positive, which implied that patients were satisfied with their treatment.|6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months|||units on a scale||Standard Deviation|Mean
746517|NCT00517699|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time interval between the entry into trial and occurrence of one of the following events: progression of disease (PD) or death as a result of primary central nervous system lymphoma (PCNSL). Participants who were withdrawn from the study without documented progression and for whom there existed case report form (CRF) evidence that evaluations had been made, were censored at the date of last tumor assessment when participant was known to be progression free. Participants without postbaseline tumor assessments but known to be alive were censored at the time of randomization. PD required a ≥25% increase in the contrast-enhanced lesion seen on MRI as compared with baseline or best response (comparison should be made to the smallest of multiple lesions); progression of ocular disease as indicated by an increase in vitreous cell count or progressive retinal or optic nerve infiltration, appearance of any new lesion or site of disease during or at the end of therapy.|Week 24|Due to early study termination, all efficacy data were documented by data listings only, no data analysis was performed.|||||
746518|NCT00517699|Secondary|Overall Survival|Time from entry into trial until death of any cause. Participants who were alive at the time of the analysis were censored at the date of the last follow-up assessment. Participants without follow-up assessment were censored at the day of last dose and participants with no post baseline information were censored at the baseline date.|Time of last follow-up assessment between Day 1 and 3 years|Due to early study termination, all efficacy data were documented by data listings only, no data analysis was performed.|||||
746519|NCT00517699|Secondary|Percentage of Participants With Initial CR or CRu and Subsequent Disease Relapse||Week 24|Due to early study termination, all efficacy data were documented by data listings only, no data analysis was performed.|||||
746520|NCT00517699|Primary|Percentage of Participants With a CR, CRu or Partial Response (PR)|PR: greater than or equal to (≥) 50 percent (%) decrease in the contrast-enhancing lesion seen on MRI as compared with the baseline images; (2) Corticosteroid dose was irrelevant to the determination of PR; for participants with ocular disease, ophthalmologic exam must show a decrease in vitreous cell count or retina/optic nerve cellular infiltrate but may have continued to show persistent malignant or suspicious cells; for participants with CSF positive for neoplastic cells, CSF cytology may be negative or continue to show persistent malignant or suspicious cells in patients with ≥50% decrease in the primary brain lesions; no new sites of disease.|Week 24|Due to early study termination, all efficacy data were documented by data listings only, no data analysis was performed.|||||
746521|NCT00517699|Primary|Percentage of Participants With a Complete Response (CR) or Unconfirmed CR (CRu)|CR: complete disappearance of all enhancing abnormalities on contrast-enhanced cranial magnetic resonance imaging (MRI); no evidence of active ocular lymphoma as defined by absence of cells in the vitreous and resolution of any previously documented retinal or optic nerve infiltrates; negative cerebrospinal fluid (CSF) cytology; at the time of CR determination, participant had discontinued use of all corticosteroids for at least 2 weeks. CRu requires fulfillment of CR criteria but with these limitations: Fulfills CR criteria but had continued requirement for corticosteroid therapy at any dose; small but persistent enhancing abnormality on MRI related to biopsy or focal hemorrhage; persistent minor abnormality on follow-up ophthalmologic exam (related to persistent non-malignant cells in vitreous, or alterations in retina/optic nerve not consistent with tumor infiltration) if the abnormality is unlikely to represent ocular lymphoma.|Week 24|Due to early study termination, all efficacy data were documented by data listings only, no data analysis was performed.|||||
746522|NCT00517751|Other Pre-specified|Percent of Subjects Who Had Any Subsequent Lumbar Spine Surgery||Overall study period|||percentage of participants|||Number
746523|NCT00517751|Other Pre-specified|Percent of Subjects Who Reported Implant-Related Adverse Events||Overall study period|||percentage of participants|||Number
746524|NCT00517751|Secondary|Right Leg Pain in Numerical Rating Scales (NRS)|"Right leg pain was measured using NRS. Patients rated their leg pain on a scale from 0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be."|Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months|||units on a scale||Standard Deviation|Mean
746525|NCT00517751|Secondary|Left Leg Pain in Numerical Rating Scales (NRS)|"Left leg pain was measured using NRS. Patients rated their leg pain on a scale from 0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be."|Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months|||units on a scale||Standard Deviation|Mean
746526|NCT00517751|Secondary|Back Pain in Numerical Rating Scales (NRS)|"Back pain was measured using NRS. Patients rated their back pain on a scale from 0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be."|Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months|||units on a scale||Standard Deviation|Mean
746527|NCT00517751|Other Pre-specified|Percent of Subjects With Pfirrmann Grades Increased at Adjacent Levels at 60 Months|The percent of subjects with Pfirrmann grades increased from baseline at adjacent levels at 60 months is reported.|60 months|At 60 months, 16 subjects were evaluable for Pfirrmann Grade assessment.||percentage of participants|||Number
746528|NCT00517751|Secondary|General Health Status -- SF-36 MCS|MCS score is between 0 and 100, with higher scores denoting better quality of life.|Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months|||units on a scale||Standard Deviation|Mean
746529|NCT00517751|Secondary|General Health Status -- SF-36 PCS|The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS is between 0 and 100, with higher scores denoting better quality of life.|Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months|||units on a scale||Standard Deviation|Mean
746530|NCT00517751|Secondary|Oswestry Disability Index (ODI) Score|ODI Questionnaire was used to assess patient back function. The ODI score ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability).|Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months|||units on a scale||Standard Deviation|Mean
746531|NCT00517751|Secondary|Success Rate in Patient Satisfaction (PS) Domain of Zurich Claudication Questionnaire (ZCQ) at Post Treatment|Success rate in PS domain of ZCQ at post treatment is reported as the percentage of participants who had success in PS domain of ZCQ. The PS success was defined as PS score less than 2.5.|6 weeks, 12months, 24 months, 36 months, 48 months, and 60 months|||percentage of participants|||Number
746533|NCT00517751|Secondary|Success Rate in Physical Function (PF) Domain of Zurich Claudication Questionnaire (ZCQ)|Success rate in PF domain of ZCQ is reported as percentage of participants who had success in PF domain of ZCQ. The PF success was defined as clinically significant improvement by at least 0.5 points in PF score compared to preoperative baseline.|6 weeks, 12months, 24 months, 36 months, 48 months, and 60 months|||percentage of participants|||Number
746534|NCT00517751|Secondary|Physical Function (PF) Scores Measured by Zurich Claudication Questionnaire (ZCQ)|PF score is the mean score of five physical function questions of ZCQ, ranging from 1 to 4. A lower score represents a better outcome/condition. If more than one item were missing, the PF score was considered as missing.|Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months|||units on a scale||Standard Deviation|Mean
746535|NCT00517751|Other Pre-specified|Percent of Subjects With Pfirrmann Grades Increased at Adjacent Levels at 24 Months|The percent of subjects with Pfirrmann grades increased from baseline at adjacent levels at 24 months is reported.|24 months|At 24 months, 53 subjects were evaluable for Pfirrmann Grade assessment.||percentage of participants|||Number
746536|NCT00517751|Other Pre-specified|Percent of Subjects With Pfirrmann Grades Increased From Baseline at Any Index Level at 60 Months|The Pfirrmann Grading System is descriptive and grades the status on an intervertebral disc as visualized with MRI using a 5-point system (grade I, II, III, IV or V). Grade I: disc is homogeneous with bright hyper-intense white signal intensity and normal disc height. Grade V: disc is inhomogeneous with hypo-intense black signal intensity and there is no more distinction between the nucleus and annulus, the disc space is collapsed. The percent of subjects with Pfirrmann grades increased from baseline at 60 months is reported.|60 months|At 60 months, 16 subjects were evaluable for Pfirrmann Grade assessment.||percentage of participants|||Number
746537|NCT00517751|Other Pre-specified|Percent of Subjects With Pfirrmann Grades Increased From Baseline at Any Index Level at 24 Months|The Pfirrmann Grading System is descriptive and grades the status on an intervertebral disc as visualized with MRI using a 5-point system (grade I, II, III, IV or V). Grade I: disc is homogeneous with bright hyper-intense white signal intensity and normal disc height. Grade V: disc is inhomogeneous with hypo-intense black signal intensity and there is no more distinction between the nucleus and annulus, the disc space is collapsed. The percent of subjects with Pfirrmann grades increased from baseline at 24 months is reported.|24 months|At 24 months, 53 subjects were evaluable for Pfirrmann Grade assessment.||percentage of participants|||Number
746538|NCT00517751|Secondary|Success Rate in Symptom Severity (SS) Domain of Zurich Claudication Questionnaire (ZCQ)|Success rate in SS domain of ZCQ is reported as percentage of participants who had success in SS domain of the ZCQ. The SS success was defined as clinically significant improvement by at least 0.5 point in SS score compared to preoperative baseline.|6 weeks, 12months, 24 months, 36 months, 48 months, and 60 months|||percentage of participants|||Number
746539|NCT00517751|Secondary|Symptom Severity (SS) Scores Measured by Zurich Claudication Questionnaire (ZCQ)|ZCQ is a validated outcomes instrument specific to lumbar spinal stenosis, and captures data in 3 distinct domains: SS, PF, and post-treatment PS. SS Score is based on seven questions (overall pain, pain frequency, pain in the back, pain in the leg, numbness, weakness, and balanced disturbance) in ZCQ. The first 6 questions are scored 1 to 5. Balance disturbance is scored in a 1-3-5 scale. The SS score is the mean of all answered items in the questionnaire, ranging from 1 to 5. A lower score represents a better outcome/condition. If more than two items were missing, the SS score was considered as missing.|Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months|||units on a scale||Standard Deviation|Mean
746540|NCT00517751|Secondary|Treatment Success Rate at 60 Months|"Treatment success rate is reported as the percentage of participants who met all of the following criteria:
Clinically significant improvement (by at least 0.5 points) in the Symptom Severity (SS) domain of the ZCQ compared to preoperative baseline
Clinically significant improvement (by at least 0.5 points) in the Physical Function (PF) domain of the ZCQ compared to pre-operative baseline
Patient satisfaction with treatment defined as a Patient Satisfaction (PS) score < 2.5
No additional surgery for lumbar stenosis performed
Maintenance of distraction
No dislodgement of the implant
No device-related complications"|60 months|At 60 months, 62 subjects were evaluable for overall treatment success. Once subjects failed on additional surgery for lumbar stenosis or dislodgement of the implant or device-related complications, they failed at later visits no matter whether they had data or not.||percentage of participants|||Number
746541|NCT00517751|Primary|Treatment Success Rate at 24 Months|"Treatment success rate is reported as the percentage of participants who met all of the following criteria:
Clinically significant improvement (by at least 0.5 points) in the Symptom Severity (SS) domain of the Zurich Claudication Questionnaire (ZCQ) compared to preoperative baseline
Clinically significant improvement (by at least 0.5 points) in the Physical Function (PF) domain of the ZCQ compared to pre-operative baseline
Patient satisfaction with treatment defined as a Patient Satisfaction (PS) score < 2.5
No additional surgery for lumbar stenosis performed
Maintenance of distraction
No dislodgement of the implant
No device-related complications"|24 months|At 24 months, 94 subjects were evaluable for overall treatment success. Once subjects failed on additional surgery for lumbar stenosis or dislodgement of the implant or device-related complications, they failed at later visits no matter whether they had data or not.||percentage of participants|||Number
746542|NCT00517829|Secondary|Duration of Response|The duration of response is measured from the time measurement criteria are first met for CR/PR until the first date that recurrent or progressive disease is objectively documented.|Treatment will continue until disease progression or intolerable toxicity|Patients who achieve a major objective response (CR or PR).||months||95% Confidence Interval|Median
746543|NCT00517829|Secondary|Time to Response|For patients who achieve a major objective response (CR or PR) the time to response will be assessed as the date of registration to the date of response.|Treatment will continue until disease progression or intolerable toxicity|Patients who achieve a major objective response (CR or PR)||months||95% Confidence Interval|Median
746544|NCT00517829|Secondary|Objective Response Rate (ORR)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.|Treatment will continue until disease progression or intolerable toxicity.|Evaluable Population||percentage of participants||95% Confidence Interval|Number
752322|NCT00558272|Secondary|N-desmethyl Metabolite of Saracatinib: Area Under the Curve at Steady State (AUCss)||Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29|||ng.h/ml||Full Range|Median
746546|NCT00517829|Primary|Progression-free Survival|"PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions."|Treatment will continue until disease progression or intolerable toxicity, up to 2 years|ITT population||months||95% Confidence Interval|Median
746547|NCT00517881|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both serious as well as non-serious AEs.|Week 0 up to Week 24|Safety population||participants|||Number
746548|NCT00517881|Secondary|Percentage of Participants With Red Blood Cell Transfusion During the Study|Percentage of participant who required red blood cell transfusion during the study was reported.|Week 0 up to Week 24|ITT Population||percentage of participants|||Number
746549|NCT00517881|Secondary|Percentage of Participants Requiring Any Dose Adjustment|Percentage of participants requiring any adjustment in the dose of study drug during the dose titration period (DTP: Week 1 to Week 16) and EEP (Week 17 to Week 24) was reported.|Week 1 up to Week 16 and Week 17 up to Week 24|ITT Population. Here, 'n' signifies the number of participants evaluable for specified category.||percentage of participants|||Number
746550|NCT00517881|Secondary|Mean Time Spent by Participants With Hemoglobin Concentration in the Target Range During the EEP|Mean time spent by participants with hemoglobin concentration within the target range of 10.5 to 12.5 g/dL during the EEP (Week 17 to Week 24) was reported.|Week 17 up to Week 24|ITT Population||days||Standard Deviation|Mean
746551|NCT00517881|Secondary|Percentage of Participants Maintaining Hemoglobin Concentration Within the Target Range During EEP|Percentage of participants maintaining hemoglobin concentration within the target range of 10.5 to 12.5 g/dL during EEP (Week 17 to Week 24) was reported.|Week 17 up to Week 24|ITT Population; data missing at the end of the EEP was handled using the last value carried forward method.||percentage of participants||95% Confidence Interval|Number
746552|NCT00517881|Secondary|Change in Hemoglobin Concentration Between Reference (SVP) and EEP|The reference hemoglobin value was defined as the mean of the 5 assessments recorded during the SVP at Weeks -4, -3, -2, -1 and 0. The mean change of the time adjusted average of hemoglobin from reference value obtained during the SVP (Week -4 up to Week 0) and the value during EEP (Week 17 up to Week 24) was assessed.|Week 17 up to Week 24|ITT population; data missing at the end of the EEP was handled using the last value carried forward method.||g/dL||Standard Deviation|Mean
746553|NCT00517881|Primary|Percentage of Participants Maintaining Mean Hemoglobin Concentration Within Plus or Minus (+/-) 1 Gram Per Deciliter (g/dL) of Their Reference Hemoglobin and Within the Target Range|Percentage of participants maintaining the mean hemoglobin concentration within +/- 1.0 g/dL of their reference hemoglobin value and within the target range of 10.5 to 12.5 g/dL during the efficacy evaluation period (EEP) was reported. The reference hemoglobin value was defined as the mean of the 5 assessments recorded during the stability verification period (SVP) at Weeks -4, -3, -2, -1 and 0. The mean hemoglobin concentration for each individual participant during the EEP (Week 17 to Week 24) was estimated as a time adjusted average.|Week 17 up to Week 24|The Intention-to-treat (ITT) population included all participants who received at least 1 dose of C.E.R.A. (week 0) and for whom data for at least 1 follow-up variable was available. Data missing at the end of the EEP (that is, the last measured hemoglobin value before Week 24) was handled using the last value carried forward method.||percentage of participants||95% Confidence Interval|Number
746554|NCT00517933|Secondary|Short Form Health Survey (SF36) Aggregate Physical|"The SF36 measures functional health and well-being scores on eight scales that correlate with two aggregate scores.
Each score ranges from 0 to 100, with a higher score indicating better function.
Mean raw scores of SF36 Aggregate Physical."|Baseline, 6 weeks, 12 weeks|||units on a scale||Standard Deviation|Mean
746555|NCT00517933|Secondary|Change in SF36 Aggregate Physical (Adjusted Value)|"The SF36 measures functional health and well-being scores on eight scales that correlate with two aggregate scores.
Each score ranges from 0 to 100, with a higher score indicating better function.
Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil – placebo."|Baseline, 12 weeks|||units on a scale||95% Confidence Interval|Mean
746556|NCT00517933|Secondary|Short Form Health Survey (SF36) General Health|"The SF36 measures functional health and well-being scores on eight scales that correlate with two aggregate scores.
Each score ranges from 0 to 100, with a higher score indicating better function.
Mean raw scores of SF36 General Health"|Baseline, 6 weeks, 12 weeks|||units on a scale||Standard Deviation|Mean
746557|NCT00517933|Secondary|Change in Short Form Health Survey (SF36) General Health - Adjusted Value|"The SF36 measures functional health and well-being scores on eight scales that correlate with two aggregate scores.
Each score ranges from 0 to 100, with a higher score indicating better function.
Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil – placebo."|Baseline, 12 weeks|||units on a scale||95% Confidence Interval|Mean
746558|NCT00517933|Secondary|EuroQOL (EQ-5D) Utility|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in total score range -0.594 to 1.000; higher score indicates better health state.
Mean raw scores of EuroQOL Utility."|Baseline, 6 weeks, 12 weeks|||units on a scale||Standard Deviation|Mean
746574|NCT00517933|Secondary|Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)|Raw scores of DLCO (% predicted) measured at baseline (time 0), week 6, and week 12 comparing the sildenafil and placebo groups|Baseline, Week 6, Week 12|ITT||percentage of predicted (DLCO)||Standard Deviation|Mean
746559|NCT00517933|Secondary|Change in EuroQOL (EQ-5D) Utility - Adjusted Value|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in total score range -0.594 to 1.000; higher score indicates better health state.
Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil – placebo."|Baseline, 12 weeks|||units on a scale||95% Confidence Interval|Mean
746560|NCT00517933|Secondary|EuroQOL Thermometer|"The thermometer score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). Higher scores indicate a better health state.
Mean raw scores of EuroQOL Thermometer."|Baseline, 6 weeks, 12 weeks|||units on a scale||Standard Deviation|Mean
746561|NCT00517933|Secondary|Change in EuroQOL Thermometer (Adjusted Value)|"The thermometer score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). Higher scores indicate a better health state.
Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil – placebo."|Baseline, 12 weeks|||units on a scale||95% Confidence Interval|Mean
746562|NCT00517933|Secondary|ICECAP-O|The ICEpop CAPability measure for Older people (ICECAP-O) is a measure of capability in older people for use in economic evaluation. The values of ICECAP-O range from 0 (worst) to 1 (best). Mean raw scores of ICECAP-O.|Baseline, 6 weeks, 12 weeks|||units on a scale||Standard Deviation|Mean
746563|NCT00517933|Secondary|Change in ICECAP-O Adjusted Value|"The ICEpop CAPability measure for Older people (ICECAP-O) is a measure of capability in older people for use in economic evaluation. The values of ICECAP-O range from 0 (worst) to 1 (best).
Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil – placebo."|Baseline, 12 weeks|||units on a scale||95% Confidence Interval|Mean
746564|NCT00517933|Secondary|St. George’s Respiratory Questionnaire (Impacts Score)|The St. George’s Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment). Mean raw scores of the St. George’s Respiratory Questionnaire.|Baseline, 6 weeks, 12 weeks|||units on a scale||Standard Deviation|Mean
746565|NCT00517933|Secondary|Change in St. George’s Respiratory Questionnaire (Impacts Score) Adjusted Value|The St. George’s Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment). Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil – placebo.|Baseline, 12 weeks|||units on a scale||95% Confidence Interval|Mean
746566|NCT00517933|Secondary|St. George’s Respiratory Questionnaire (Activity Score)|The St. George’s Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment). Mean raw scores of the St. George’s Respiratory Questionnaire.|Baseline, 6 weeks, 12 weeks|||units on a scale||Standard Deviation|Mean
746567|NCT00517933|Secondary|Change in St. George’s Respiratory Questionnaire (Activity Score) Adjusted Value|The St. George’s Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment). Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil – placebo.|Baseline, 12 weeks|||units on a scale||95% Confidence Interval|Mean
746568|NCT00517933|Secondary|St. George’s Respiratory Questionnaire (Symptoms Score)|The St. George’s Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment). Mean raw scores of the St. George's Respiratory Questionnaire. Mean raw scores of the St. George’s Respiratory Questionnaire.|Baseline, 6 weeks, 12 weeks|||units on a scale||Standard Deviation|Mean
746569|NCT00517933|Secondary|Change in St. George’s Respiratory Questionnaire (Symptoms Score) Adjusted Value|The St. George’s Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment). Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil – placebo.|Baseline, 12 weeks|||units on a scale||95% Confidence Interval|Mean
746570|NCT00517933|Secondary|St. George’s Respiratory Questionnaire (Total Score)|Mean raw scores of the St. George’s Respiratory Questionnaire. The St. George’s Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment.)|Baseline, 6 weeks, 12 weeks|||units on a scale||Standard Deviation|Mean
746571|NCT00517933|Secondary|Change in St. George’s Respiratory Questionnaire (Total Score) (Adjusted Values)|The St. George’s Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment.) Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil – placebo.|Baseline, 12 week|||units on a scale||95% Confidence Interval|Mean
746572|NCT00517933|Secondary|Borg Dyspnea Index (BDI) After 6 Minute Walk Test (Raw Scores)|The BDI was calculated by using a 10-point scale (0 = None, 10 = Maximum) and indicates the degree of breathlessness after completion of the 6-minute walk test.|Baseline, 6 week, 12 week|||units on a scale||Standard Deviation|Mean
746573|NCT00517933|Secondary|Change in Borg Dyspnea Index (BDI) After 6 Minute Walk Test (Adjusted Values)|The BDI was calculated by using a 10-point scale (0 = None, 10 = Maximum) and indicates the degree of breathlessness after completion of the 6-minute walk test. Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil – placebo.|Baseline, 12 week|||units on a scale||95% Confidence Interval|Mean
746575|NCT00517933|Secondary|Change in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) Adjusted Values|Change in DLCO (% predicted) measured at baseline (time 0), and week 12 comparing the sildenafil and placebo groups. All models adjust for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil – placebo.|Baseline, Week 12|ITT||percentage of predicted (DLCO)||95% Confidence Interval|Least Squares Mean
746576|NCT00517933|Secondary|Forced Vital Capacity (FVC)|Raw scores of FVC (liters) from baseline (time 0) to week 6 and 12 comparing the sildenafil and placebo groups|Baseline, Week 6, Week 12|ITT||liters||Standard Deviation|Mean
746577|NCT00517933|Secondary|Change in Forced Vital Capacity (FVC) Adjusted Values|Change in FVC (liters) from baseline (time 0) to week 12 comparing the sildenafil and placebo groups. Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil – placebo.|Baseline, Week 12|ITT||liters||95% Confidence Interval|Least Squares Mean
746578|NCT00517933|Secondary|University of California at San Diego (UCSD) Shortness of Breath Questionnaire Total|"The University of California at San Diego Shortness of Breath Questionnaire (SOBQ) uses a 6-point scale (0 = not at all to 5 = maximal or unable to do because of breathlessness) to rate 24 items. The final score ranges from 0 to 120 -- lower scores are better. (Raw scores)
Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil – placebo."|Baseline, 6 weeks, 12 weeks|||units on a scale||Standard Deviation|Mean
746579|NCT00517933|Secondary|Change in Dyspnea|"The University of California at San Diego Shortness of Breath Questionnaire (SOBQ) uses a 6-point scale (0 = not at all to 5 = maximal or unable to do because of breathlessness) to rate 24 items. The final score ranges from 0 to 120 -- lower scores are better."|Measured from enrollment to 12 weeks (phase I)|||units on a scale||95% Confidence Interval|Mean
746580|NCT00517933|Secondary|Desaturation During 6-minute Walk Test (6MWT)|The 6MWT was stopped when the pulse oximetry (SpO2) dropped to below 80% for six consecutive seconds. The estimates are based on the Kaplan-Meier event curves with minutes walked as the x-axis.|Week 12|ITT population||percentage of participants||95% Confidence Interval|Number
746581|NCT00517933|Secondary|Estimated Change From Baseline to 12 Weeks in 6-minute Walk Distance|The 6MWT measures the distance that a participant can walk in a period of 6 minutes. All models adjust for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil – placebo.|Baseline, week 12|||meters||95% Confidence Interval|Mean
746582|NCT00517933|Secondary|6-minute Walk Distance (6MWT)|The 6MWT measures the distance that a participant can walk in a period of 6 minutes.|Baseline, 6 week, 12 week|||meters||Standard Deviation|Mean
746583|NCT00517933|Primary|Change in 6-minute Walk Distance From Enrollment to Week 12 (≥ 20% Improvement)|This is a binary score (1 or 0) with 1 being better than 0. All models adjust for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil – placebo.|Measured at Week 12|||participants|||Number
746584|NCT00518011|Secondary|Mean Change in Body Temperature From Baseline|Mean change in body temperature from Baseline for each cycle calculated as Day 1 of each cycle value minus baseline value.|Baseline (Day -14 to Day 0), Cycle 1 (Days 1, 8, 15 and 22), Cycle 2 (Days 1, 8, 15 and 22), Cycle 3 (Days 1, 8, and 15), Cycle 4 (Days 1, 8, and 15), Cycle 5 (Days 1, 8, and 15), Cycle 6 (Days 1, 8, and 15)|Safety population included all participants who received at least one dose/infusion and had at least one safety assessment performed at baseline.||Fahrenheit||Standard Deviation|Mean
746585|NCT00518011|Secondary|Mean Change in Blood Pressure From Baseline|Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were recorded as vital parameters in this study. Mean change in SBP and DBP from Baseline for each cycle calculated as Day 1 of each cycle value minus baseline value.|Baseline (Day -14 to Day 0), Cycle 1 (Days 1, 8, 15 and 22), Cycle 2 (Days 1, 8, 15 and 22), Cycle 3 (Days 1, 8, and 15), Cycle 4 (Days 1, 8, and 15), Cycle 5 (Days 1, 8, and 15), Cycle 6 (Days 1, 8, and 15)|Safety population included all participants who received at least one dose or infusion of study treatment and had a safety assessment performed at Baseline.||mm Hg||Standard Deviation|Mean
746586|NCT00518011|Secondary|Mean Change in Pulse Rate From Baseline|Mean change in pulse rate from Baseline for each cycle calculated as Day 1 of each cycle value minus Baseline value|Baseline (Day -14 to Day 0), Cycle 1 (Days 1, 8, 15 and 22), Cycle 2 (Days 1, 8, 15 and 22), Cycle 3 (Days 1, 8, and 15), Cycle 4 (Days 1, 8, and 15), Cycle 5 (Days 1, 8, and 15), Cycle 6 (Days 1, 8, and 15)|Safety population included all participants who received at least one dose or infusion of study treatment and had a safety assessment performed at baseline.||beats per minute||Standard Deviation|Mean
746587|NCT00518011|Secondary|Overall Survival|Overall survival was defined as the interval between the date of randomization to the date of death from any cause.|Up to 2 years|PP population included all randomized participants who received at least one dose of study medication and had at least one post baseline tumor assessment or record of death||Week||95% Confidence Interval|Median
746588|NCT00518011|Secondary|Duration of Response|Duration of response was defined as the interval between the date of CR or PR was first recorded to the date on which progressive disease was first noted or date of death.|Up to 2 years|PP population included all randomized participants received at least one dose of study medication and had at least one post baseline tumor assessment or record of death. Participants available at the time of evaluation of duration of response were included in the analysis.||Week||Standard Deviation|Mean
746598|NCT00518115|Secondary|Mean Absorption Rate of Albiglutide|Absorption rate is defined as the rate at which albiglutide enters the blood circulation. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 4, 5, 7, 8, 9, 12, 15) and on the day of the clinic visit at Weeks 16, 17, 18, 20, 23, and 27. The Week 5, 8, and 12 post-dose (PK sampling was performed within 6 days of drug administration.|Weeks 0, 4, 5, 7, 8, 9, 12, 15, 16, 17 18, 20, 23, and 27|PK Analysis Population||hour^-1||95% Confidence Interval|Mean
746815|NCT00525824|Secondary|Percent Change in TC/HDL-C After 6 Weeks Combination Treatment|Percent change in TC/HDL-C = (Combination treatment value - Baseline value)/Baseline value*100|Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)|||Percentage||Standard Deviation|Mean
746589|NCT00518011|Secondary|Disease Control Rate|Disease control rate was defined as the percentage of participants who have any evidence of confirmed objective CR or PR or Stable disease (SD) (where SD was maintained for 8 weeks), as assessed by the RECIST version 1.0 criteria. As per the RECIST Version 1.0 CR is defined as disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum of the LD. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum of the LD since the treatment started. PD is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum of the LD recorded since the treatment started or the appearance of one or more new lesions.|Up to 2 years|PP population included all randomized participants who received at least one dose of study medication and had at least one post baseline tumor assessment or record of death.||Percentage of participants|||Number
746590|NCT00518011|Secondary|Objective Response Rate|Objective response rate was defined as the percentage of participants who have any evidence of confirmed objective of complete response (CR) + partial response (PR), as assessed by the Response Evaluation Criteria In Solid Tumors (RECIST version 1.0) criteria. As per the RECIST Version 1.0 CR is defined as disappearance of all target lesions and PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of the LD.|Up to 2 years|PP population included all randomized participants who received at least one dose of study medication and had at least one post baseline tumor assessment or record of death.||Percentage of participants|||Number
746591|NCT00518011|Primary|Progression Free Survival|Progression free survival was defined as the interval between the day of randomization and the date of the first documentation of disease progression or date of death (from any cause), whichever occurs first.|Up to 2 years|Per protocol (PP) population included all randomized participants who received at least one dose of study medication and had at least one post baseline tumor assessment or record of death.||Week||95% Confidence Interval|Median
746592|NCT00518089|Primary|Percentage of Patients With Clearing (Clinical Success) of Conjunctival Hyperemia and Conjunctival Discharge Up to Day 6|Percentage of patients that achieved clinical success, defined as achievement of a score of zero for both conjunctival hyperemia and conjunctival discharge in the study eye up to Day 6. Conjunctival hyperemia and conjunctival discharge were each assessed on a 4-point severity grade scale (0=none, +1=mild, +2=moderate, +3=severe).|6 Days|"Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria. (Note: The Up to Day 6 analysis included all data up to the Day 6 time point but excluded any Day 6 visit data that was collected after the Day 6 time point)."||Percentage of Patients|||Number
746593|NCT00518089|Secondary|Percentage of Patients With Clinical Improvement of Ocular Symptoms Up to Day 6|Percentage of patients with clinical improvement of ocular symptoms, defined as a decrease (improvement) up to Day 6 from Day 1 (Baseline) in the total score of itching and tearing (each on 4-point scale: 0 = none, 1 = mild, 2 = moderate, and 3 = severe), with no increase (worsening) from Day 1 (Baseline) in any individual score in the study eye diagnosed with bacterial conjunctivitis.|6 Days|"Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria. (Note: The Up to Day 6 analysis included all data up to the Day 6 time point but excluded any Day 6 visit data that was collected after the Day 6 time point)."||Percentage of Patients|||Number
746594|NCT00518089|Secondary|Percentage of Patients With Clinical Improvement of Ocular Signs Up to Day 6|Percentage of patients with clinical improvement of ocular signs up to Day 6 based on a 4-point scale (0 = none, 1 = mild, 2 = moderate, and 3 = severe), defined as a decrease (improvement) from Day 1 (Baseline) in the total score of conjunctival hyperemia and mucopurulent discharge (pus), with no increase (worsening) from Day 1 (Baseline) in either individual variable in the study eye.|6 Days|"Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria. (Note: The Up to Day 6 analysis included all data up to the Day 6 time point but excluded any Day 6 visit data that was collected after the Day 6 time point)."||Percentage of Patients|||Number
746595|NCT00518089|Secondary|Percentage of Patients With Microbiological Cure Up to Day 6|Percentage of patients with microbiological cure, defined such that all bacteria present in the study eye at Day 1 (Baseline) are eradicated up to Day 6 based on a Classification of Microbial Response. (Eradication=pathogen is absent in follow-up culture; Reduction=pathogen is reduced from baseline below threshold count in follow-up culture; Persistence=pathogen reduced from baseline but is above or equal to threshold count in follow-up culture; and Proliferation=pathogen has increased in count from baseline in follow-up culture).|6 Days|"Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria. (Note: The Up to Day 6 analysis included all data up to the Day 6 time point but excluded any Day 6 visit data that was collected after the Day 6 time point)."||Percentage of Patients|||Number
746596|NCT00518089|Secondary|Percentage of Patients With Clearing (Clinical Success) of Conjunctival Hyperemia and Conjunctival Discharge at Day 6|Percentage of patients that achieved clinical success, defined as achievement of a score of zero for both conjunctival hyperemia and conjunctival discharge in the study eye at Day 6. Conjunctival hyperemia and conjunctival discharge were each assessed on a 4-point severity grade scale (0=none, +1=mild, +2=moderate, +3=severe).|Day 6|"Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria. (Note: The Day 6 analysis included all Day 6 visit data, regardless of whether it was collected on Day 6 or on a later day)."||Percentage of Patients|||Number
746597|NCT00518115|Secondary|Mean Half-maximal Effective Concentration (EC50) of Albiglutide for HbA1c and FPG|EC50 is defined as the concentration of albiglutide that give a half-maximal HbA1c and FPG response. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 4, 5, 7, 8, 9, 12, 15) and on the day of the clinic visit at Weeks 16, 17, 18, 20, 23, and 27. The Week 5, 8, and 12 post-dose (PK sampling was performed within 6 days of drug administration. EC50 estimates used PK data as well as HbA1c and FPG efficacy data. EC50 was estimated from an inhibitory Emax (maximal possible effect of albiglutide) model.|Weeks 0, 4, 5, 7, 8, 9, 12, 15, 16, 17 18, 20, 23, and 27|PK/PD Analysis Population: all participants in the PK Analysis Population with sufficient dosing history for inclusion in the PK/PD analysis||nanograms per milliliter||95% Confidence Interval|Mean
752323|NCT00558272|Secondary|Saracatinib: Time to Cssmax (Tmax)||Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29|||h||Full Range|Median
746599|NCT00518115|Secondary|Mean Volume of Distribution of Albiglutide|Volume of distribution is defined as the apparent volume in which albiglutide is distributed. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 4, 5, 7, 8, 9, 12, 15) and on the day of the clinic visit at Weeks 16, 17, 18, 20, 23, and 27. The Week 5, 8, and 12 post-dose (PK sampling was performed within 6 days of drug administration.|Weeks 0, 4, 5, 7, 8, 9, 12, 15, 16, 17 18, 20, 23, and 27|PK Analysis Population||Liters||95% Confidence Interval|Mean
746600|NCT00518115|Secondary|Mean Clearance of Albiglutide|Clearance is defined as the volume of plasma cleared of albiglutide per unit time. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 4, 5, 7, 8, 9, 12, 15) and on the day of the clinic visit at Weeks 16, 17, 18, 20, 23, and 27. The Week 5, 8, and 12 post-dose pharmacokinetic (PK) sampling was performed within 6 days of drug administration.|Weeks 0, 4, 5, 7, 8, 9, 12, 15, 16, 17 18, 20, 23, and 27|PK Analysis Population: all participants for whom a PK sample was obtained and analyzed||milliliters per hour||95% Confidence Interval|Mean
746601|NCT00518115|Secondary|Number of Participants With the Indicated Response to Questions on the Hunger, Craving, and Fullness Questionnaire (HCFQ) at Week 16|"The HCFQ questionnaire is used to record how often participants have felt hungry or craved food, and how full participants felt after finishing meals, on average, in the past week. Participants answered the following seven questions with the response that best described their feelings of hunger, craving, and fullness: Q1, In the past week I was hungry; Q2, In the past week I thought about food; Q3, In the past week I wanted to eat; Q4, In the past week I ate more than I should have; Q5, In the past week, I craved specific food; Q6, In the past week when finished meals I felt full; Q7, In the past week when finished meals I felt satisfied."|Week 16|Safety Population. Only those participants available at the specified time point were analyzed.||Participants|||Number
746602|NCT00518115|Secondary|Change From Baseline in Functional Living Index – Emesis (FLIE) Scores at Week 16|The FLIE questionnaire is used to record the participant's feelings/opinions concerning the effects of nausea/vomiting on their quality of life during the past five days. Participants completed the questionnaire by responding to 18 questions. The first set of 9 questions refer to nausea, and the second set of 9 questions refer to vomiting. Each question is scored on a seven-point visual analog scale (1 to 7). On this scale, a score of 1 corresponds to 0 millimeters (mm), and a score of 7 correspond to 100 mm. Anything in between is marked at the appropriate point on the scale and is measured in mm. Data are reported in mm in this table. In FLIE questions (FLIEQ) 1, 2, 4, 5, 7, 8, 9, 10, 12, 13, 14, 16, and 17, a score of 1 indicates no effect on the quality of life, and a score of 7 indicates a great effect on the quality of life. In FLIEQ 3, 6, 11, 15, and 18, a score of 1 indicates a great effect on the quality of life, and a score of 7 indicates no effect on the quality of life.|Baseline and Week 16|Safety Population: all randomly assigned participants who received at least one dose of study drug. Only those participants available at the specified time point were analyzed. Change from Baseline was calculated as the score at Week 16 minus the score at Baseline.||Score on a scale||Standard Deviation|Mean
746603|NCT00518115|Secondary|Change From Baseline in Triglycerides, Free Fatty Acids, Total Cholesterol, Low-density Lipoprotein Cholesterol, and High-density Lipoprotein Cholesterol at Weeks 5, 8, 12, and 16|Serum lipid components, including triglycerides (TG), free fatty acids (FFA), total cholesterol (CL), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C), were measured at Baseline and Weeks 5, 8, 12, and 16. The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Baseline and Weeks 5, 8, 12, and 16|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||mmol/L||Standard Deviation|Mean
746604|NCT00518115|Secondary|Change From Baseline in Fasting Insulin at Weeks 5, 8, 12, and 16|Fasting insulin levels were measured after the participant had not eaten (fasted) for at least eight hours prior to the sampling. The Baseline insulin value is the last non-missing value before the start of treatment. Change from Baseline in insulin was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Baseline and Weeks 5, 8, 12, and 16|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Picomoles per liter (pmol/L)||Standard Deviation|Mean
746605|NCT00518115|Secondary|Change From Baseline in Fasting Glucagon at Weeks 5, 8, 12, and 16|Fasting glucagon levels were measured after the participant had not eaten (fasted) for at least eight hours prior to the sampling. The Baseline glucagon value is the last non-missing value before the start of treatment. Change from Baseline in glucagon was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Baseline and Weeks 5, 8, 12, and 16|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Nanograms per liter (ng/L)||Standard Deviation|Mean
746606|NCT00518115|Secondary|Change From Baseline in Fasting C-peptide at Weeks 5, 8, 12, and 16|Fasting C-peptide levels were measured after the participant had not eaten (fasted) for at least eight hours prior to the sampling. The Baseline C-peptide value is the last non-missing value before the start of treatment. Change from Baseline in C-peptide was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Baseline and Weeks 5, 8, 12, and 16|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Nanomoles per liter (nmol/L)||Standard Deviation|Mean
746607|NCT00518115|Secondary|Change From Baseline in Fasting Fructosamine at Weeks 5, 8, 12, and 16|Fasting fructosamine levels were measured after the participant had not eaten (fasted) for at least eight hours prior to the sampling. The Baseline fructosamine value is the last non-missing value before the start of treatment. Change from Baseline in fructosamine was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Baseline and Weeks 5, 8, 12, and 16|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Micromoles per liter (µmol/L)||Standard Deviation|Mean
746608|NCT00518115|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 4, 5, 7, 8, 9, 12, 15, and 16|The FPG test measures blood sugar levels after the participant has not eaten (fasted) for at least eight hours prior to the sampling. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline in FPG was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Baseline and Weeks 4, 5, 7, 8, 9, 12, 15, and 16|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Millimoles per liter (mmol/L)||Standard Deviation|Mean
746609|NCT00518115|Secondary|Percent Change From Baseline in Body Weight at Week 16|The Baseline value is the last non-missing value before the start of treatment. Change from Baseline in body weight was calculated as the value at Week 16 minus the value at Baseline. Percent change from Baseline was calculated as the ([value at Week 16 minus the Baseline value] divided by the Baseline value) multiplied by 100. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Baseline and Week 16|ITT Population. Only participants with a value at Baseline and at Week 16 were analyzed.||Percent change||Standard Deviation|Mean
746610|NCT00518115|Secondary|Change From Baseline in Body Weight at Week 16|The Baseline value is the last non-missing value before the start of treatment. Change from Baseline in body weight was calculated as the value at Week 16 minus the value at Baseline. The last observation carried forward (LOCF) method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Baseline and Week 16|ITT Population. Only participants with a value at Baseline and at Week 16 were analyzed.||Kilograms (Kg)||Standard Deviation|Mean
746611|NCT00518115|Secondary|Change From Baseline in Waist Circumference at Week 16|The Baseline value is the last non-missing value before the start of treatment. Change from Baseline in waist circumference was calculated as the value at Week 16 minus the value at Baseline. The last observation carried forward (LOCF) method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Baseline and Week 16|ITT Population. Only participants with a value at Baseline and at Week 16 were analyzed.||Centimeters||Standard Deviation|Mean
746623|NCT00518180|Secondary|Geometric Mean Titers (GMTs) of Anti-HPV by Competitive Luminex Immunoassay|To compare the immune response of HPV vaccine given concomitantly with MenACWY and Tdap to the response when HPV vaccine is given alone. (Immune response against HPV virus-like particles (VLPs) for types 6, 11, 16, and 18 was measured at one month after the third HPV vaccine vaccination.)|1 month post third HPV vaccination|The analysis was performed on the per-protocol (PP) population.||Titers||95% Confidence Interval|Geometric Mean
746816|NCT00525824|Secondary|Percent Change in Apolipoprotein A1 (ApoA-1) After 6 Weeks Combination Treatment|Percent change in ApoA-1 = (Combination treatment value - Baseline value)/Baseline value*100|Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)|||Percentage||Standard Deviation|Mean
746612|NCT00518115|Secondary|Number of Participants Who Achieved Target Values for HbA1c <6.5% and >=6.5% to <7% at Weeks 4, 5, 7, 8, 9, 12, 15, and 16|The number of participants who achieved target values for HbA1c (i.e., HbA1c <6.5% and >=6.5% to <7%) were assessed. The last observation carried forward (LOCF) method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Weeks (W) 4, 5, 7, 8, 9, 12, 15, and 16|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Participants|||Number
746613|NCT00518115|Secondary|Change From Baseline in HbA1c at Weeks 4, 5, 7, 8, 9, 12, 15, and 16|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline in HbA1c was calculated as the post-Baseline value minus the value at Baseline. The last observation carried forward (LOCF) method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Baseline and Weeks 4, 5, 7, 8, 9, 12, 15, and 16|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Percentage of HbA1c in the blood||Standard Deviation|Mean
746614|NCT00518115|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 16|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline in HbA1c was calculated as the value at Week 16 minus the value at Baseline. Based on ANCOVA: Change = treatment + Baseline HbA1c + prior therapy + gender + region. The last observation carried forward (LOCF) method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Baseline and Week 16|Intent-to-Treat (ITT) Population: all randomly assigned participants with at least one post-Baseline assessment of the primary endpoint. Participants from the exenatide arm were not included in the analysis. Only those participants with a value at Baseline and at the specified visit were analyzed.||Percentage of HbA1c in the blood||Standard Error|Least Squares Mean
746615|NCT00518180|Secondary|Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination|Number of subjects with specified local and systemic reactions were solicited for 7 days after the HPV vaccination.|Days 1 to 7|The analysis was performed on the safety population.||Subjects|||Number
746616|NCT00518180|Secondary|Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination.|Number of subjects with specified local and systemic reactions were assessed when MenACWY was given alone, one month after Tdap, and concomitantly with Tdap and HPV vaccine.|Days 1 to 7|The analysis was performed on the safety set.||Subjects|||Number
746617|NCT00518180|Primary|Geometric Mean Concentrations (GMC) of Antipertussis Toxin (Anti-PT), Antifilamentous Hemagglutinin (Anti-FHA), and Antipertactin (Anti-PRN)|To compare the immune response of Tdap given concomitantly with MenACWY and HPV vaccine with the immune response of Tdap when administered alone|1 month post Tdap vaccination|The analysis was performed on the per-protocol (PP) population.||IU/mL||95% Confidence Interval|Geometric Mean
746618|NCT00518180|Secondary|Percentages of Subjects With at Least a 4-fold Rise for PT, FHA, and PRN|To compare the immune response of Tdap, defined by the percentage of subjects with a 4-fold rise in antibody titer over baseline against PT, FHA, PRN, when administered one month after the MenACWY with the immune response of Tdap when administered alone.|1 month post Tdap vaccination|The analysis was performed on the per-protocol (PP) population.||Percentages of subjects||95% Confidence Interval|Number
746619|NCT00518180|Secondary|Geometric Mean Titers (GMT) of Pertussis Antigens|To compare the immune response to Tdap administered one month after MenACWY with the immune response to Tdap administered alone.|1 month post Tdap vaccination|The analysis was performed on the per-protocol (PP) population.||Titers||95% Confidence Interval|Geometric Mean
746620|NCT00518180|Secondary|Geometric Mean Concentrations (GMC) for Diphtheria and Tetanus|To compare the immune response of Tdap, as measured by the antidiphtheria and antitetanus GMCs, when administered one month after the MenACWY vaccine with the immune response of the Tdap vaccine when administered alone.|1 month post Tdap vaccination|The analysis was performed on the per-protocol (PP) population.||IU/mL||95% Confidence Interval|Geometric Mean
746621|NCT00518180|Secondary|The Effect of Sequential Vaccination on Immunogenicity for Diphtheria and Tetanus|The immune response to the Tdap vaccine, as measured by the percentage of subjects with antidiphtheria and antitetanus toxin ≥1.0 IU/mL.|1 month post Tdap vaccination|The analysis was performed on the per-protocol (PP) population.||Percentages of subjects||95% Confidence Interval|Number
746622|NCT00518180|Secondary|Percentage of Subjects With hSBA ≥ 1:8, hSBA Titer ≥ 1:4, for A, C, W, and Y Serogroups|The immune responses to MenACWY, as measured by the percentage of subjects with hSBA titer ≥ 1:8, hSBA titer ≥ 1:4, when given: (a) alone, (b) concomitantly with Tdap and HPV vaccine; and (c) when given one month after Tdap.|1 month post MenACWY vaccination|The analysis was performed on the per-protocol (PP) population.||Percentage of subjects||95% Confidence Interval|Number
746638|NCT00523939|Primary|Response Rate|To evaluate response rate using intrathecal DepoCytTM in two cohorts of patients, one with active lymphomatous meningitis and another with active leukemic meningitis.|1 year|Primary outcome measure was not assessed due to early study termination.|||||
746624|NCT00518180|Secondary|Percentage of Subjects With Anti-HPV Seroconversion|To compare the immune response of HPV vaccine given concomitantly with MenACWY and Tdap to the response when HPV vaccine is given alone. (Immune response against HPV virus-like particles (VLPs) for types 6, 11, 16, and 18 was measured at one month after the third HPV vaccination.) Anti-HPV Seroconversion (SC): SC was defined as negative (baseline HPV titer < type-specific cut-off) for anti-HPV and anti-HPV ≥ an HPV type-specific cut-off at one month after the third HPV injection.|1 month post third HPV vaccination|The analysis was performed on the per-protocol (PP) population.||Percentage of subjects||95% Confidence Interval|Number
746625|NCT00518180|Secondary|Effect of Concomitant and Sequential Vaccination on hSBA Geometric Mean Titers (GMTs) for A, C, W, and Y Serogroups|The immune responses to the MenACWY conjugate vaccine, as measured by the hSBA Geometric Mean Titers (GMTs) when given: (a) alone, (b) concomitantly with the Tdap vaccine and the HPV vaccine, and (c) when given one month after the Tdap vaccine.|1 month post MenACWY vaccination|The analysis was performed on the per-protocol (PP) population.||Titers||95% Confidence Interval|Geometric Mean
746626|NCT00518180|Primary|Percentage of Subjects With Antidiphtheria and Antitetanus Toxin ≥1.0 IU/mL|To compare the immune response to Tdap given concomitantly with MenACWY and HPV vaccine with the immune response to Tdap when administered alone|1 month post Tdap vaccination|The analysis was performed on the per-protocol (PP) population. A total of 183 subjects were excluded from the PP population due to protocol deviations. The most common protocol deviations were blood draw performed outside the protocol-specified window.||Percentage of subjects||95% Confidence Interval|Number
746627|NCT00518180|Primary|Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse|"Immune responses to MenACWY, as measured by the percentage of hSBA seroresponders, when given: (a) alone; (b) concomitantly with a Tetanus diphtheria acellular pertussis (Tdap) vaccine and a Human Papillomavirus Recombinant (HPV) vaccine; and (c) when given one month after a Tdap vaccine.
Seroresponse to MenACWY: For a subject with baseline hSBA titer <1:4, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with baseline hSBA titer ≥ 1:4, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline."|1 month post MenACWY vaccination|The analysis was performed on the per-protocol (PP) population. A total of 182 subjects were excluded from the PP population due to protocol deviations. The most common protocol deviations were blood draw performed outside the protocol-specified window.||Percentage of participants||95% Confidence Interval|Number
746628|NCT00518206|Secondary|Number of Subjects With Treatment-emergent Adverse Events|Toxicity was graded in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events (version 3.0). Treatment-emergent adverse events (TEAEs) were reported based on clinical laboratory tests, physical examinations, and vital signs from pre-treatment through the study period. Dose-limiting toxicity was defined as any treatment-related grade 4 toxicity or any grade 3 toxicity, excluding grade 3 skin necrosis at the site of the delayed-type hypersensitivity reaction, fever, or asymptomatic hyperglycemia that improved to baseline within 3 weeks of onset.|Up to 22 months|The Safety Analysis Set comprises all subjects who received at least 1 dose of study drug.||participants|||Number
746629|NCT00518206|Secondary|Humoral Immunogenicity of the NY-ESO-1 ISCOM Vaccine|Blood samples were drawn to measure humoral immunologic response at pretreatment and weeks 3, 7, 11, 33, and every 12 weeks thereafter. Humoral immunity was assessed by measurement of antibodies to NY-ESO-1 by enzyme-linked immunosorbent assay (ELISA). Data are presented according to baseline (BL) NY-ESO-1 antibody positivity and the time to seroconversion, if applicable.|Up to 22 months|Subjects with available measurement of baseline and post-baseline positivity for NY-ESO-1 antibodies.||Participants|||Count of Participants
746630|NCT00518206|Secondary|Post-Vaccination Delayed-type Hypersensitivity (DTH) Reactions|NY-ESO-1-specific DTH was measured by intradermal injection with the full-length NY-ESO-1 protein, NY-ESO-1b peptide, and NY-ESO-1 DP4 peptide at pretreatment, week 11, and between week 23 and 25. DTH reactions (eg, local skin irritation) were evaluated 2 days after DTH injections. Data presented are based on injections with the full-length peptide, as these data are considered to be representative of the comprehensive DTH results.|Up to 22 months|Subjects who underwent DTH testing with available DTH reaction evaluation(s).||Participants|||Count of Participants
746631|NCT00518206|Secondary|Cellular Immunogenicity of the NY-ESO-1 ISCOM Vaccine|Blood samples were drawn to measure cellular response at pretreatment and weeks 3, 7, 11, between weeks 23 and 25, week 33, and every 12 weeks thereafter. Cellular immunity included an assay for gamma interferon-producing T cells and enumeration of NY-ESO-1b-specific T cells, detected by fluorescent labeled human leukocyte antigen (HLA)-A2 tetramers carrying the NY-ESO-1b peptide, expressed as percent positive staining of CD4+ and CD8+ T cells. Data are presented for CD4+ and CD8+ T-cell responses (not mutually exclusive) that were pre-existing at baseline (BL) or presented at any time post-BL.|Up to 22 months|Subjects with available results from the evaluation of T-cell responses in peripheral blood.||participants|||Number
746632|NCT00518206|Primary|Number of Subjects With Best Overall Tumor Response|Tumor responses were evaluated using computed tomography and categorized according to RECIST (version 1.0) at baseline, at week 11, between weeks 23 and 25, and every 12 weeks thereafter. Per RECIST, target lesions are categorized as follows: Complete Response (CR): Disappearance of all target lesions [no evidence of disease]; Partial Response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria.|Up to 22 months|Subjects with data available from at least 1 post-baseline response assessment.||Participants|||Count of Participants
746633|NCT00523809|Primary|Progression-free Survival (PFS)|Number or participants with no disease progression or death for any reason during first 100 days following transplantation. Participants followed every 3 months for first year.|100 days after transplant|Study objectives were not meet, analysis was not performed.|||||
746634|NCT00523848|Secondary|Time to Disease Progression||Every 3 monthsntil the date of first documented progression or date of death from any cause, whichever came first|||months||95% Confidence Interval|Median
746635|NCT00523848|Secondary|Complete Response Rate||Every 3 months|Evaluable patients.||percentage of participants||95% Confidence Interval|Number
746636|NCT00523848|Primary|Overall Response Rate (Complete and Partial)||Every 3 months|Evaluable patients||percentage of participants||95% Confidence Interval|Number
746637|NCT00523939|Secondary|Time to Neurologic Progression||2 years||||||
786245|NCT00839241|Primary|Frequency of Natural Killer Cells as Measured With Flow Cytometry.||Baseline|||total number of cells * 10^5/mL||Standard Deviation|Mean
746639|NCT00523978|Primary|Cryoablation Procedure Events (CPEs)|Subjects that had CPEs. CPEs were device- or procedure-related serious adverse events (SAE) categorized as access site complications, cardiac damage, pulmonary vein (PV) stenosis, embolic complications, arrhythmias, unresolved phrenic nerve palsy and death.|To end of ablation procedure|Data for subjects who were randomized to the Experimental group and received cryoablation therapy were included in this analysis. All CPEs reported in the Experimental group were included in the analysis regardless of their association with the first or a repeat cryoablation.||participants|||Number
746640|NCT00523978|Primary|Freedom From Major Atrial Fibrillation Events (MAFEs)|Subjects that did not have or were free of MAFEs. MAFEs were serious adverse events categorized as cardiovascular death, myocardial infarction, stroke, or hospitalization for AF recurrence/ablation, flutter ablation, embolic events, heart failure, hemorrhage or anti-arrhythmic drug treatment.|12 Months|mITT set included all subjects (82 CS, 163 ES) who were enrolled, randomized, and received treatment.||participants|||Number
746641|NCT00523978|Primary|Treatment Success|Treatment Success was defined as Acute Procedure Success (APS) and freedom from Chronic Treatment Failure (CTF) for Experimental Subjects, and freedom from CTF for Control Subjects. Under this pre-specified definition of Treatment Success, Experimental Subjects must have had APS and remained free of CTF during the 12-month follow-up duration, while Control Subjects must have remained free of CTF during the 12-month follow-up duration.|12 months|The mITT population consisted of all subjects, who were enrolled, randomized and received treatment||participants|||Number
746642|NCT00523978|Primary|Freedom From Chronic Treatment Failure (CTF)|Subjects that did not have or were free of CTF. CTF was defined as the occurence of an Atrial Fibrillation (AF) intervention, use of non-study AF drug therapy, or the occurence of detectable AF which is is defined as an episode of AF, documented in a tracing, and lasting more than 30 seconds, occurring during a Non Blanked Follow-up Period.|12 month follow up period|This section includes data for subjects who were randomized, received treatment and were followed through 12-Months post randomized treatment regardless of AF Drug usage. Subjects who experienced Acute Procedural Failure in the Experimental group were not included in this analysis of post-procedural failure causes.||participants|||Number
746643|NCT00523978|Primary|Acute Procedural Success (APS)|Acute Procedural Success was defined as a demonstration of electrical isolation in ≥ 3 Pulmonary Veins (PVs) at the conclusion of the first protocol-defined cryoablation procedure. APS was decided at the end of the procedure the mean time was calculated for the time frame.|371.4 Minutes (Average)|Subjects evaluated were from the modified Intent to Treat subset (mITT)or subjects that were enrolled, randomized and received treatment.||participants|||Number
746644|NCT00523991|Secondary|Change From Baseline in Number of Steps Per Day (Week 24)|Change from baseline in number of steps per day (week 24)|baseline, week 24|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days||Steps||Standard Error|Least Squares Mean
746645|NCT00523991|Secondary|Change From Baseline in Number of Steps Per Day (Week 20)|Change from baseline in number of steps per day (week 20)|baseline, week 20|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days||Steps||Standard Error|Least Squares Mean
746646|NCT00523991|Secondary|Change From Baseline in Number of Steps Per Day (Week 16)|Change from baseline in number of steps per day (week 16)|baseline, week 16|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days||Steps||Standard Error|Least Squares Mean
746647|NCT00523991|Secondary|Change From Baseline in Number of Steps Per Day (Week 12)|Change from baseline in Number of steps per day (week 12)|baseline, week 12|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days||Steps||Standard Error|Least Squares Mean
746648|NCT00523991|Secondary|Change From Baseline in Number of Steps Per Day(Week 8)|Change from baseline in number of steps per day (week 8)|baseline, week 8|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days||Steps||Standard Error|Least Squares Mean
746649|NCT00523991|Secondary|Change From Baseline in Number of Steps Per Day (Week 4)|Change from baseline in number of steps per day (week 4)|baseline, week 4|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days||Steps||Standard Error|Least Squares Mean
746650|NCT00523991|Secondary|Number of Steps Per Day (Baseline)|Number of steps per day (baseline)|baseline|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days||Steps||Standard Deviation|Mean
746651|NCT00523991|Secondary|Change From Baseline in Active Energy Expenditure (Week 24)|The amount of energy (kcal/day) that a person uses while physically active.|baseline, week 24|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days||kilo calories per day||Standard Error|Least Squares Mean
746652|NCT00523991|Secondary|Change From Baseline in Active Energy Expenditure (Week 20)|The amount of energy (kcal/day) that a person uses while physically active.|baseline, week 20|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days||kilo calories per day||Standard Error|Least Squares Mean
746653|NCT00523991|Secondary|Change From Baseline in Active Energy Expenditure (Week 16)|The amount of energy (kcal/day) that a person uses while physically active.|baseline, week 16|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days||kilo calories per day||Standard Error|Least Squares Mean
746654|NCT00523991|Secondary|Change From Baseline in Active Energy Expenditure (Week 12)|The amount of energy (kcal/day) that a person uses while physically active.|baseline, week 12|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days||kilo calories per day||Standard Error|Least Squares Mean
746655|NCT00523991|Secondary|Change From Baseline in Active Energy Expenditure (Week 8)|The amount of energy (kcal/day) that a person uses while physically active.|baseline, week 8|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days||kilo calories per day||Standard Error|Least Squares Mean
746656|NCT00523991|Secondary|Change From Baseline in Active Energy Expenditure (Week 4)|The amount of energy (kcal/day) that a person uses while physically active.|baseline, week 4|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days||kilo calories per day||Standard Error|Least Squares Mean
746657|NCT00523991|Secondary|Active Energy Expenditure (Baseline)|The amount of energy (kcal/day) that a person uses while physically active.|baseline|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days||kilo calories per day||Standard Deviation|Mean
746658|NCT00523991|Secondary|Number of Participants With Healthy Lifestyle (Week 24)|Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no|week 24|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days||Participants|||Number
746659|NCT00523991|Secondary|Number of Participants With Healthy Lifestyle (Week 20)|Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no|week 20|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days||Participants|||Number
746660|NCT00523991|Secondary|Number of Participants With Healthy Lifestyle (Week 16)|Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no|week 16|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days||Participants|||Number
746661|NCT00523991|Secondary|Number of Participants With Healthy Lifestyle (Week 12)|Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no|week 12|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days||Participants|||Number
746662|NCT00523991|Secondary|Number of Participants With Healthy Lifestyle (Week 8)|Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no|week 8|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days||Participants|||Number
746663|NCT00523991|Secondary|Number of Participants With Healthy Lifestyle (Week 4)|Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no|week 4|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days||Participants|||Number
746664|NCT00523991|Secondary|Number of Participants With Healthy Lifestyle (Baseline)|Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no|baseline|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days||Participants|||Number
746665|NCT00523991|Secondary|Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 24) in Logarithm of Average Time Spent in Minutes Per Day|"Moderate or higher intensity is greater than or equal to three metabolic equivalents
Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject’s resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.
ln in measure value unit means natural logarithm"|baseline, week 24|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days||ln(minutes)||Standard Error|Least Squares Mean
746666|NCT00523991|Secondary|Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 20) in Logarithm of Average Time Spent in Minutes Per Day|"Moderate or higher intensity is greater than or equal to three metabolic equivalents
Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject’s resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.
ln in measure value unit means natural logarithm"|baseline, week 20|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days||ln(minutes)||Standard Error|Least Squares Mean
746728|NCT00523991|Secondary|Change From Baseline in Forced Vital Capacity (Week 16, 30 Minutes)|Change from baseline in forced vital capacity (week 16, 30 minutes)|baseline, week 16, 30 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
746667|NCT00523991|Secondary|Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 16) in Logarithm of Average Time Spent in Minutes Per Day|"Moderate or higher intensity is greater than or equal to three metabolic equivalents
Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject’s resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.
ln in measure value unit means natural logarithm"|baseline, week 16|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days||ln(minutes)||Standard Error|Least Squares Mean
746668|NCT00523991|Secondary|Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 12) in Logarithm of Average Time Spent in Minutes Per Day|"Moderate or higher intensity is greater than or equal to three metabolic equivalents
Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject’s resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.
ln in measure value unit means natural logarithm"|baseline, week 12|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days||ln(minutes)||Standard Error|Least Squares Mean
746669|NCT00523991|Secondary|Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 8) in Logarithm of Average Time Spent in Minutes Per Day|"Moderate or higher intensity is greater than or equal to three metabolic equivalents
Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject’s resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.
ln in measure value unit means natural logarithm"|baseline, week 8|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days||ln(minutes)||Standard Error|Least Squares Mean
746670|NCT00523991|Secondary|Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 4) in Logarithm of Average Time Spent in Minutes Per Day|"Moderate or higher intensity is greater than or equal to three metabolic equivalents
Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject’s resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.
ln in measure value unit means natural logarithm"|baseline, week 4|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days||ln(minutes)||Standard Error|Least Squares Mean
746671|NCT00523991|Secondary|Physical Activity (Moderate or Higher Intensity; Baseline) in Logarithm of Average Time Spent in Minutes Per Day|"Moderate or higher intensity is greater than or equal to three metabolic equivalents
Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject’s resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.
ln in measure value unit means natural logarithm"|baseline|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days||ln(minutes)||Standard Deviation|Mean
746672|NCT00523991|Secondary|Change From Baseline in Physical Activity (Light Intensity; Week 24) in Logarithm of Average Time Spent in Minutes Per Day|"Light intensity is less than three metabolic equivalents
Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject’s resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.
ln in measure value unit means natural logarithm"|baseline, week 24|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days||ln(minutes)||Standard Error|Least Squares Mean
746673|NCT00523991|Secondary|Change From Baseline in Physical Activity (Light Intensity; Week 20) in Logarithm of Average Time Spent in Minutes Per Day|"Light intensity is less than three metabolic equivalents
Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject’s resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.
ln in measure value unit means natural logarithm"|baseline, week 20|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days||ln(minutes)||Standard Error|Least Squares Mean
746674|NCT00523991|Secondary|Change From Baseline in Physical Activity (Light Intensity; Week 16) in Logarithm of Average Time Spent in Minutes Per Day|"Light intensity is less than three metabolic equivalents
Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject’s resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.
ln in measure value unit means natural logarithm"|baseline, week 16|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days||ln(minutes)||Standard Error|Least Squares Mean
746729|NCT00523991|Secondary|Change From Baseline in Forced Vital Capacity (Week 16, Pre-dose)|Change from baseline in forced vital capacity (week 16, pre-dose)|baseline, week 16, pre-dose|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
746675|NCT00523991|Secondary|Change From Baseline in Physical Activity (Light Intensity; Week 12) in Logarithm of Average Time Spent in Minutes Per Day|"Light intensity defined as less than three metabolic equivalents.
Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject’s resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.
ln in measure value unit means natural logarithm"|baseline, week 12|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days||ln(minutes)||Standard Error|Least Squares Mean
746676|NCT00523991|Secondary|Change From Baseline in Physical Activity (Light Intensity; Week 8) in Logarithm of Average Time Spent in Minutes Per Day|"Light intensity is less than three metabolic equivalents
Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject’s resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.
ln in measure value unit means natural logarithm"|baseline, week 8|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days||ln(minutes)||Standard Error|Least Squares Mean
746677|NCT00523991|Secondary|Change From Baseline in Physical Activity (Light Intensity; Week 4) in Logarithm of Average Time Spent in Minutes Per Day|"Light intensity is less than three metabolic equivalents
Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject’s resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.
ln in measure value unit means natural logarithm"|baseline, week 4|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days||ln(minutes)||Standard Error|Least Squares Mean
746678|NCT00523991|Secondary|Physical Activity (Light Intensity; Baseline) in Logarithm of Average Time Spent in Minutes Per Day|"Light intensity is less than three metabolic equivalents.
Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject’s resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.
ln in measure value unit means natural logarithm."|baseline|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days||ln(minutes)||Standard Deviation|Mean
746679|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 24)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 24 and baseline.|baseline, week 24|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||units on a scale||Standard Error|Least Squares Mean
746680|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 20)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 20 and baseline.|baseline, week 20|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||units on a scale||Standard Error|Least Squares Mean
746681|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 16)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 16 and baseline.|baseline, week 16|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||units on a scale||Standard Error|Least Squares Mean
746682|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 12)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 12 and baseline.|baseline, week 12|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||units on a scale||Standard Error|Least Squares Mean
747590|NCT00530842|Secondary|Static Lung Volumes (Percent)|Trough RV/TLC (Residual Volume over Total Lung Capacity) after 4 weeks (measured by bodyphlethysmography)|4 weeks|FAS using imputed values||Percent of RV over TLC||Standard Error|Mean
746683|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 8)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 8 and baseline.|baseline, week 8|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||units on a scale||Standard Error|Least Squares Mean
746684|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 4)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 4 and baseline.|baseline, week 4|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||units on a scale||Standard Error|Least Squares Mean
746685|NCT00523991|Secondary|Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Baseline)|"WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment.
Absenteeism, Presenteeism, Work productivity loss, Activity Impairment Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment."|baseline|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||units on a scale||Standard Deviation|Mean
746686|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 24)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 24 and baseline.|baseline, week 24|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||units on a scale||Standard Error|Least Squares Mean
746687|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 20)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 20 and baseline.|baseline, week 20|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||units on a scale||Standard Error|Least Squares Mean
746688|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 16)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 16 and baseline.|baseline, week 16|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||units on a scale||Standard Error|Least Squares Mean
746689|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 12)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 12 and baseline.|baseline, week 12|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||units on a scale||Standard Error|Least Squares Mean
746730|NCT00523991|Secondary|Change From Baseline in Forced Vital Capacity (Week 8, 180 Minutes)|Change from baseline in forced vital capacity (week 8, 180 minutes)|baseline, week 8, 180 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
746731|NCT00523991|Secondary|Change From Baseline in Forced Vital Capacity (Week 8, 120 Minutes)|Change from baseline in forced vital capacity (week 8, 120 minutes)|baseline, week 8, 120 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
746690|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 8)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 8 and baseline.|baseline, week 8|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||units on a scale||Standard Error|Least Squares Mean
746691|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 4)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 4 and baseline.|baseline, week 4|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||units on a scale||Standard Error|Least Squares Mean
746692|NCT00523991|Secondary|Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Baseline)|"WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment.
Absenteeism, Presenteeism, Work productivity loss, Activity Impairment Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment."|baseline|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||units on a scale||Standard Deviation|Mean
746693|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 24)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 24 and baseline.|baseline, week 24|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||units on a scale||Standard Error|Least Squares Mean
746694|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 20)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 20 and baseline.|baseline, week 20|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||units on a scale||Standard Error|Least Squares Mean
746695|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 16)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 16 and baseline.|baseline, week 16|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||units on a scale||Standard Error|Least Squares Mean
746696|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 12)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 12 and baseline.|baseline, week 12|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||units on a scale||Standard Error|Least Squares Mean
746732|NCT00523991|Secondary|Change From Baseline in Forced Vital Capacity (Week 8, 60 Minutes)|Change from baseline in forced vital capacity (week 8, 60 minutes)|baseline, week 8, 60 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
746817|NCT00525824|Secondary|Percent Change in Apolipoprotein B (ApoB) After 6 Weeks Combination Treatment|Percent change in ApoB = (Combination treatment value - Baseline value)/Baseline value*100|Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)|||Percentage||Standard Deviation|Mean
746697|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 8)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 8 and baseline.|baseline, week 8|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||units on a scale||Standard Error|Least Squares Mean
746698|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 4)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 4 and baseline.|baseline, week 4|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||units on a scale||Standard Error|Least Squares Mean
746699|NCT00523991|Secondary|Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health|"WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment.
Absenteeism, Presenteeism, Work productivity loss, Activity Impairment Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment."|baseline|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||units on a scale||Standard Deviation|Mean
746700|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 24)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 24 and baseline.|baseline, week 24|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||units on a scale||Standard Error|Least Squares Mean
746701|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 20)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 20 and baseline.|baseline, week 20|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||units on a scale||Standard Error|Least Squares Mean
746702|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 16)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 16 and baseline.|baseline, week 16|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||units on a scale||Standard Error|Least Squares Mean
746703|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 12)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 12 and baseline.|baseline, week 12|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||units on a scale||Standard Error|Least Squares Mean
746733|NCT00523991|Secondary|Change From Baseline in Forced Vital Capacity (Week 8, 30 Minutes)|Change from baseline in forced vital capacity (week 8, 30 minutes)|baseline, week 8, 30 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
746734|NCT00523991|Secondary|Change From Baseline in Forced Vital Capacity (Week 8, Pre-dose)|Change from baseline in forced vital capacity (week 8, pre-dose)|baseline, week 8, pre-dose|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
746704|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 8)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 8 and baseline.|baseline, week 8|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||units on a scale||Standard Error|Least Squares Mean
746705|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 4)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 4 and baseline.|baseline, week 4|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||units on a scale||Standard Error|Least Squares Mean
746706|NCT00523991|Secondary|Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Baseline)|"WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment.
Absenteeism, Presenteeism, Work productivity loss, Activity Impairment Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment."|baseline|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||units on a scale||Standard Deviation|Mean
746707|NCT00523991|Secondary|Number of Participants With Categorical Scores on Patient's Global Assessment (Week 24)|"The patient’s global assessment was based on the subject’s need to take additional medications for breathing, their need for emergency room or hospital visits for COPD, and severity and amount of coughing, wheezing, and/or breathing discomfort experienced, and the impact of these symptoms on the subject’s ability to exercise and perform daily activities.
Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent."|week 24|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||Participants|||Number
746708|NCT00523991|Secondary|Number of Participants With Categorical Scores on Patient's Global Assessment (Week 12)|"The patient’s global assessment was based on the subject’s need to take additional medications for breathing, their need for emergency room or hospital visits for COPD, and severity and amount of coughing, wheezing, and/or breathing discomfort experienced, and the impact of these symptoms on the subject’s ability to exercise and perform daily activities.
Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent."|week 12|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||Participants|||Number
746709|NCT00523991|Secondary|Number of Participants With Categorical Scores on Patient's Global Assessment (Baseline)|"The patient’s global assessment was based on the subject’s need to take additional medications for breathing, their need for emergency room or hospital visits for COPD, and severity and amount of coughing, wheezing, and/or breathing discomfort experienced, and the impact of these symptoms on the subject’s ability to exercise and perform daily activities.
Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent."|baseline|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||Participants|||Number
746710|NCT00523991|Secondary|Number of Participants With Categorical Scores on Physician's Global Assessment (Week 24)|"The physician's global assessment reflected the physician's opinion of the participant's overall clinical condition with respect to COPD. The evaluation was based on the participant's use of concomitant medications, as well as the number and severity of COPD exacerbations and related emergency room visits and/or hospitalizations since the last visit. The frequency and severity of symptoms ( cough, dyspnea, wheezing) and the impact of these on the participant's ability to exercise were considered.
Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent."|week 24|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||Participants|||Number
746711|NCT00523991|Secondary|Number of Participants With Categorical Scores on Physician's Global Assessment (Week 12)|"The physician's global assessment reflected the physician's opinion of the participant's overall clinical condition with respect to COPD. The evaluation was based on the participant's use of concomitant medications, as well as the number and severity of COPD exacerbations and related emergency room visits and/or hospitalizations since the last visit. The frequency and severity of symptoms ( cough, dyspnea, wheezing) and the impact of these on the participant's ability to exercise were considered.
Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent."|week 12|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||Participants|||Number
746735|NCT00523991|Secondary|Forced Vital Capacity (Baseline, 180 Minutes)|Forced vital capacity (baseline, 180 minutes)|baseline, 180 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
746736|NCT00523991|Secondary|Forced Vital Capacity (Baseline, 120 Minutes)|Forced vital capacity (baseline, 120 minutes)|baseline, 120 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
746712|NCT00523991|Secondary|Number of Participants With Categorical Scores on Physician's Global Assessment (Baseline)|"The physician's global assessment reflected the physician's opinion of the participant's overall clinical condition with respect to COPD. The evaluation was based on the participant's use of concomitant medications, as well as the number and severity of COPD exacerbations and related emergency room visits and/or hospitalizations since the last visit. The frequency and severity of symptoms ( cough, dyspnea, wheezing) and the impact of these on the participant's ability to exercise were considered.
Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent."|baseline|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||Participants|||Number
746713|NCT00523991|Secondary|Change From Baseline in Albuterol Use p.r.n. - (Week 24)|Difference in number of days that participants used albuterol prn per week between week 24 and baseline|baseline, week 24|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||days||Standard Error|Least Squares Mean
746714|NCT00523991|Secondary|Change From Baseline in Albuterol Use p.r.n. -(Week 20)|Difference in number of days that participants used albuterol prn per week between week 20 and baseline|baseline, week 20|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||days||Standard Deviation|Mean
746715|NCT00523991|Secondary|Change From Baseline in Albuterol Use p.r.n. - (Week 16)|Difference in number of days that participants used albuterol prn per week between week 16 and baseline|baseline, week 16|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||days||Standard Deviation|Mean
746716|NCT00523991|Secondary|Change From Baseline in Albuterol Use p.r.n. -(Week 12)|Difference in number of days that participants used albuterol prn per week between week 12 and baseline|baseline, week 12|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||days||Standard Deviation|Mean
746717|NCT00523991|Secondary|Change From Baseline in Albuterol Use p.r.n. - (Week 8)|Difference in number of days that participants used albuterol prn per week between week 8 and baseline|baseline, week 8|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||days||Standard Deviation|Mean
746718|NCT00523991|Secondary|Change From Baseline in Albuterol Use p.r.n. - (Week 4)|Difference in number of days that participants used albuterol prn per week between week 4 and baseline|baseline, week 4|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||days||Standard Deviation|Mean
746719|NCT00523991|Secondary|Albuterol Use p.r.n. (Baseline)|Number of days that participants used albuterol prn per week|baseline|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||days||Standard Deviation|Mean
746720|NCT00523991|Secondary|Change From Baseline in Forced Vital Capacity (Week 24, 180 Minutes)|Change from baseline in forced vital capacity (week 24, 180 minutes)|baseline, week 24, 180 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Error|Least Squares Mean
746721|NCT00523991|Secondary|Change From Baseline in Forced Vital Capacity (Week 24, 120 Minutes)|Change from baseline in forced vital capacity (week 24, 120 minutes)|baseline, week 24, 120 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Error|Least Squares Mean
746722|NCT00523991|Secondary|Change From Baseline in Forced Vital Capacity (Week 24, 60 Minutes)|Change from baseline in forced vital capacity (week 24, 60 minutes)|baseline, week 24, 60 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Error|Least Squares Mean
746723|NCT00523991|Secondary|Change From Baseline in Forced Vital Capacity (Week 24, 30 Minutes)|Change from baseline in forced vital capacity (week 24, 30 minutes)|baseline, week 24, 30 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Error|Least Squares Mean
746724|NCT00523991|Secondary|Change From Baseline in Forced Vital Capacity (Week 24, Pre-dose)|Change from baseline in forced vital capacity (week 24, pre-dose)|baseline, week 24, pre-dose|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Error|Least Squares Mean
746725|NCT00523991|Secondary|Change From Baseline in Forced Vital Capacity (Week 16, 180 Minutes)|Change from baseline in forced vital capacity (week 16, 180 minutes)|baseline, week 16, 180 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
746726|NCT00523991|Secondary|Change From Baseline in Forced Vital Capacity (Week 16, 120 Minutes)|Change from baseline in forced vital capacity (week 16, 120 minutes)|baseline, week 16, 120 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
746727|NCT00523991|Secondary|Change From Baseline in Forced Vital Capacity (Week 16, 60 Minutes)|Change from baseline in forced vital capacity (week 16, 60 minutes)|baseline, week 16, 60 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
746737|NCT00523991|Secondary|Forced Vital Capacity (Baseline, 60 Minutes)|Forced vital capacity (baseline, 60 minutes)|baseline, 60 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
746738|NCT00523991|Secondary|Forced Vital Capacity (Baseline, 30 Minutes)|Forced vital capacity (baseline, 30 minutes)|baseline, 30 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
746739|NCT00523991|Secondary|Forced Vital Capacity (Baseline, Pre-dose)|Forced vital capacity (baseline, pre-dose)|baseline|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
746740|NCT00523991|Secondary|Change From Baseline in Peak Forced Vital Capacity (at Week 24)|Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.|baseline, week 24|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Error|Least Squares Mean
746741|NCT00523991|Secondary|Change From Baseline in Peak Forced Vital Capacity (at Week 16)|Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.|baseline, week 16|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
746742|NCT00523991|Secondary|Change From Baseline in Peak Forced Vital Capacity (at Week 8)|Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.|baseline, week 8|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
746743|NCT00523991|Secondary|Peak Forced Vital Capacity (FVC) (Baseline)|Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1.|baseline|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
746744|NCT00523991|Secondary|Change From Baseline in Trough Forced Vital Capacity (at Week 24)|Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.|baseline, week 24|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Error|Least Squares Mean
746745|NCT00523991|Secondary|Change From Baseline in Trough Forced Vital Capacity (at Week 16)|Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.|baseline, week 16|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
746746|NCT00523991|Secondary|Change From Baseline in Trough Forced Vital Capacity (at Week 8)|Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.|baseline, week 8|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
746747|NCT00523991|Secondary|Trough Forced Vital Capacity (Baseline)|Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.|baseline|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
746748|NCT00523991|Secondary|FVC AUC0-3 at Week 24 Minus Baseline|Change from baseline in Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h) (week 24)|baseline, week 24|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres * hours||Standard Error|Least Squares Mean
746749|NCT00523991|Secondary|FVC AUC0-3 at Week 16 Minus Baseline|Change from baseline in Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h)(week 16)|baseline, week 16|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres * hours||Standard Deviation|Mean
746750|NCT00523991|Secondary|FVC AUC0-3 at Week 8 Minus Baseline|Change from baseline in Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h) (week 8)|baseline, week 8|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres * hours||Standard Deviation|Mean
746751|NCT00523991|Secondary|FVC AUC0-3 at Baseline|Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h)|baseline|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres * hours||Standard Deviation|Mean
746752|NCT00523991|Secondary|Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 180 Minutes)|Change from baseline in peak forced expiratory volume in 1 second (at week 24, 180 minutes)|baseline, week 24, 180 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Error|Least Squares Mean
746784|NCT00524030|Secondary|Mean Time on Pregabalin Monotherapy||Week 2 to Week 20|MITT Full Study Set; N=number of participants entering Monotherapy Period||Days||Standard Deviation|Mean
746753|NCT00523991|Secondary|Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 120 Minutes)|Change from baseline in peak forced expiratory volume in 1 second (at week 24, 120 minutes)|baseline, week 24, 120 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Error|Least Squares Mean
746754|NCT00523991|Secondary|Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 60 Minutes)|Change from baseline in peak forced expiratory volume in 1 second (at week 24, 60 minutes)|baseline, week 24, 60 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Error|Least Squares Mean
746755|NCT00523991|Secondary|Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 30 Minutes)|Change from baseline in peak forced expiratory volume in 1 second (at week 24, 30 minutes)|baseline, week 24, 30 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Error|Least Squares Mean
746756|NCT00523991|Secondary|Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, Pre-dose)|Change from baseline in peak forced expiratory volume in 1 second (at week 24, pre-dose)|baseline, week 24, pre-dose|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Error|Least Squares Mean
746757|NCT00523991|Secondary|Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 180 Minutes)|Change from baseline in peak forced expiratory volume in 1 second (at week 16, 180 minutes)|baseline, week 16, 180 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
746758|NCT00523991|Secondary|Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 120 Minutes)|Change from baseline in peak forced expiratory volume in 1 second (at week 16, 120 minutes)|baseline, week 16, 120 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
746759|NCT00523991|Secondary|Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 60 Minutes)|Change from baseline in peak forced expiratory volume in 1 second (at week 16, 60 minutes)|baseline, week 16, 60 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
746760|NCT00523991|Secondary|Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 30 Minutes)|Change from baseline in peak forced expiratory volume in 1 second (at week 16, 30 minutes)|Baseline, week 16, 30 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
746761|NCT00523991|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 16, Pre-dose)|Change from baseline in forced expiratory volume in 1 second (at week 16, pre-dose)|baseline, week 16, pre-dose|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
746762|NCT00523991|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 180 Minutes)|Change from baseline in forced expiratory volume in 1 second (at week 8, 180 minutes)|baseline, week 8, 180 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
746763|NCT00523991|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 120 Minutes)|Change from baseline in forced expiratory volume in 1 second (at week 8, 120 minutes)|baseline, week 8, 120 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
746764|NCT00523991|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 60 Minutes)|Change from baseline in forced expiratory volume in 1 second (at week 8, 60 minutes)|baseline, week 8, 60 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
746765|NCT00523991|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 30 Minutes)|Change from baseline in forced expiratory volume in 1 second (at week 8, 30 minutes)|Baseline, week 8, 30 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
746766|NCT00523991|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, Pre-dose)|Change from baseline in forced expiratory volume in 1 second (at week 8, pre-dose)|baseline, week 8, pre-dose|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
746767|NCT00523991|Secondary|Forced Expiratory Volume in 1 Second (Baseline, 180 Minutes)|Forced expiratory volume in 1 second (baseline, 180 minutes)|Baseline, 180 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
746768|NCT00523991|Secondary|Forced Expiratory Volume in 1 Second (Baseline, 120 Minutes)|Forced expiratory volume in 1 second (baseline, 120 minutes)|Baseline, 120 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
746795|NCT00524121|Secondary|Response by Phosphor Epidermal Growth Factor Receptor (pEGFR) Expression||Radiologic evaluation every 3 months, up to 5 years|||participants|||Number
746796|NCT00524121|Secondary|Response by Epidermal Growth Factor Receptor (EGFR) Expression||Radiologic evaluation every 3 months, up to 5 years|||participants|||Number
746769|NCT00523991|Secondary|Forced Expiratory Volume in 1 Second (Baseline, 60 Minutes)|Forced expiratory volume in 1 second (baseline, 60 minutes)|baseline, 60 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
746770|NCT00523991|Secondary|Forced Expiratory Volume in 1 Second (Baseline, 30 Minutes)|Forced expiratory volume in 1 second (baseline, 30 minutes)|baseline, 30 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
746771|NCT00523991|Secondary|Forced Expiratory Volume in 1 Second (Baseline, Pre-dose)|Forced expiratory volume in 1 second (baseline, pre-dose)|Baseline|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
746772|NCT00523991|Secondary|Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24)|Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.|Baseline, week 24|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Error|Least Squares Mean
746773|NCT00523991|Secondary|Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16)|Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.|Baseline, week 16|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
746774|NCT00523991|Secondary|Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 8)|Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.|Baseline, week 8|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
746775|NCT00523991|Secondary|Peak Forced Expiratory Volume in 1 Second (Baseline)|Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1.|Baseline|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
746776|NCT00523991|Secondary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 24)|Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.|Baseline, week 24|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Error|Least Squares Mean
746777|NCT00523991|Secondary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 16)|Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.|Baseline, week 16|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
746778|NCT00523991|Secondary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 8)|Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.|Baseline, week 8|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
746779|NCT00523991|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1)(Baseline)|Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.|Baseline|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
746780|NCT00523991|Primary|Change From Baseline in Lung Function as Measured by the Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve From 0-3h (AUC0-3h)|Change = Week 24 Value – Baseline Value|baseline, week 24|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres * hours||Standard Error|Least Squares Mean
746781|NCT00524030|Secondary|Pregabalin Exposure-Response Analysis|Percentage of participants predicted to exit the study due to any seizure exit criteria at Day 126. The exit rate at Day 126 was predicted using the final model (log normal distribution with respect to treatment group) and the parameter estimates.|Day 126|MITT Full Study Set||Percentage of Participants|||Number
746782|NCT00524030|Secondary|Pregabalin Population Pharmacokinetics (PK)|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Baseline up to 20 weeks||||||
746783|NCT00524030|Secondary|Percentage of Seizure-Free Participants by Study Phase|Percentage of participants who were seizure-free during the last 28 days on double-blind study medication (monotherapy phase, Days 112-140), during the monotherapy portion of the double-blind treatment phase (Days 56-140), and during all of the double-blind treatment phase (Days 1-140)|Day 1 up to Day 140|MITT Full Study Set||Percentage of Participants|||Number
746785|NCT00524030|Secondary|Percentage of Participants Who Met Protocol-Specified Exit Events|Percentage of participants experiencing any of the following (could have had more than 1): 1) episode of SE; 2) SGTC seizure if none had been experienced within 2 years of study entry; 3) 28-day study seizure rate during DBP >2 times the Max 28-day study seizure rate during BLP; 4) 2-day study seizure rate during the DBP >2 times the Max 2-day study seizure rate during BLP; or 5) unacceptable clinically significant increase in frequency/intensity of seizure activity|Week 2 up to Week 18|MITT Efficacy Set||Percentage of Participants|||Number
746786|NCT00524030|Secondary|Percentage of Participants Completing 20 Weeks of Double-Blind Treatment||Randomization up to Week 20|MITT Full Study Set||Percentage of Participants|||Number
746787|NCT00524030|Secondary|Percentage of Participants in the Pregabalin 150 mg/Day Treatment Group Discontinuing the Study Due to at Least 1 Pre-Defined Seizure Exit Criteria|Participants who discontinued due to: episode of SE; SGTC seizure if none within 2 years of study entry; 28-day study seizure rate during DBP >2 times Max 28-day study seizure rate during BLP; 2-day study seizure rate during DBP >2 times Max 2-day study seizure rate during BLP; or unacceptable clinically significant increase in frequency/intensity of seizure activity. Determined as exit rate, defined as (1-KM product limit estimate for survival function) * 100%|Week 2 up to Week 18|MITT Full Study Set: all randomized participants who met the MITT definition (received at least 1 dose of pregabalin in DB treatment phase, had BL seizure assessment, and participated in DB efficacy assessment after Week 2)||Percentage of Participants||95% Confidence Interval|Number
746788|NCT00524030|Primary|Percentage of Participants in the Pregabalin 600 mg/Day Treatment Group Discontinuing the Study Due to at Least 1 Pre-Defined Seizure Exit Criteria|Participants who discontinued due to: episode of status epilepticus (SE); secondarily generalized tonic-clonic (SGTC) seizure if none within 2 years of study entry; 28-day study seizure rate during double-blind phase (DBP) greater than (>)2 times maximum (Max) 28-day study seizure rate during baseline phase (BLP); 2-day study seizure rate during DBP >2 times Max 2-day study seizure rate during BLP; or unacceptable clinically significant increase in frequency/intensity of seizure activity. Determined as exit rate:(1-Kaplan-Meier [KM] product limit estimate for survival function) * 100%|Week 2 up to Week 18|Modified Intent to Treat (MITT) Efficacy Set: The first 125 participants randomized who received at least 1 dose of pregabalin in DB treatment phase, had BL seizure assessment, and participated in DB efficacy assessment after Week 2. Number of participants analyzed (N)= number of MITT participants with discontinuation/completion data.||Percentage of Participants||95% Confidence Interval|Number
746789|NCT00524043|Secondary|Change From Baseline to End Point (Week 6 or the Last Assessment After the Baseline Assessment) in MOS SF-36 Mental Component Summary Scale Score|The MOS SF-36 is a measure of patient-reported health status. It is a 36-item questionnaire measuring 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Each domain score ranges from 0 (worst) to 100 (best), with higher scores reflecting better health-related functional status. Two summary scale scores are computed based on weighted combinations of the 8 domain scores: the Physical Component Summary and the Mental Component Summary.|Baseline, 6 weeks|The intent-to-treat analysis set included all enrolled patients who received at least 1 dose of paliperidone ER or placebo and had both the baseline and at least 1 postbaseline efficacy assessment.||units on a scale||Standard Deviation|Mean
746790|NCT00524043|Secondary|Change From Baseline to End Point (Week 6 or the Last Assessment After the Baseline Assessment) in MOS SF-36 Physical Component Summary Scale Score|The Medical Outcomes Study Short Form Health Survey-36 (MOS SF-36) is a measure of patient-reported health status. It is a 36-item questionnaire measuring 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Each domain score ranges from 0 (worst) to 100 (best), with higher scores reflecting better health-related functional status. Two summary scale scores are computed based on weighted combinations of the 8 subscale scores: the Physical Component Summary and the Mental Component Summary.|Baseline, 6 weeks|The intent-to-treat analysis set included all enrolled patients who received at least 1 dose of paliperidone ER or placebo and had both the baseline and at least 1 postbaseline efficacy assessment.||units on a scale||Standard Deviation|Mean
746791|NCT00524043|Secondary|Change From Baseline to End Point (Week 6 or the Last Assessment After the Baseline Assessment) in PSP Score|The Personal and Social Performance (PSP) scale assesses the degree of difficulty (ranging from i [absent] to vi [very severe]) a patient exhibits over a 1-month period in socially useful activities, personal and social relationships, self care, and disturbing and aggressive behavior. The overall score ranges from 1 to 100. Patients with scores of 71 to 100 have a mild degree of difficulty; patients with scores from 31 to 70 have various degrees of disability; and patients with scores of 30 or less function so poorly as to require intensive supervision.|Baseline, 6 weeks|The intent-to-treat analysis set included all enrolled patients who received at least 1 dose of paliperidone ER or placebo and had both the baseline and at least 1 postbaseline efficacy assessment.||units on a scale||Standard Deviation|Mean
746792|NCT00524043|Secondary|Change From Baseline to the End of the Double-blind Treatment Phase (Week 6 or the Last Assessment Obtained After the Baseline Assessment) in CGI-S|The Clinical Global Impression-Severity (CGI-S) rating scale is used by psychiatrists to rate the severity of a patient's psychotic condition on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe). The scale permits a global evaluation of the patient's condition at a given time.|Baseline, 6 weeks|The intent-to-treat analysis set included all enrolled patients who received at least 1 dose of paliperidone ER or placebo and had both the baseline and at least 1 postbaseline efficacy assessment.||units on a scale||Full Range|Median
746793|NCT00524043|Primary|Change From Baseline in PANSS Total Score at the End of the Double-blind Treatment Phase (Week 6 or the Last Assessment Obtained After the Baseline Assessment).|The Positive and Negative Syndrome Scale (PANSS) is a tool used by psychiatrists to measure the symptoms of psychosis experienced by a patient with schizophrenia. It includes 30 items that produce a total score ranging from a minimum of 30 (indicating least severe symptoms of illness) to a maximum of 120 (indicating most severe symptoms of illness). A negative change in score from baseline to end point indicates improvement in the symptoms of illness.|Baseline, 6 weeks|The intent-to-treat analysis set included all enrolled patients who received at least 1 dose of paliperidone ER or placebo and had both the baseline and at least 1 postbaseline efficacy assessment.||units on a scale||Standard Deviation|Mean
746794|NCT00524121|Secondary|Response by EGFR Mutation Status||Radiologic evaluation every 3 months, up to 5 years|||participants|||Number
746798|NCT00524121|Secondary|Effect of Study Therapy on Overall Quality of Life as Assessed by FACT-E Scale|Functional Assessment of Cancer Therapy-Esophagus (FACT-E) is a health-related quality of life instrument validated in esophageal cancer patients. All of the scales and single-item measures range in score from 0 to 4. The ranges of average quality of life scores was from 0 to 4 and was adjusted as lower scores indicate better outcomes|Baseline and Week 3|Patients Treated with Study Therapy and with FACT-E scores available||FACT-E Score||Full Range|Median
746799|NCT00524121|Secondary|Progresssion-Free Survival|Progression is defined as at least a 20% increase in the sum of long distance of target lesions taking as reference the smallest sum long distance recorded since the treatment started or the appearance of one or more new lesions, or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|Every 3 months, up to 5 years|||months||95% Confidence Interval|Median
746800|NCT00524121|Secondary|Complete Response|"Response assessment by CT scans and upper endoscopy performed between 4-8 weeks after completion of radiation.
Complete Response (CR) is defined as absence of viable tumor in endoscopic evaluation post chemoradiation, with four-quadrant biopsies taken at 1 cm intervals throughout length of original tumor."|4-8 weeks after completion of radiation.|Patients Treated with Study Therapy||percentage of participants||95% Confidence Interval|Number
746801|NCT00524121|Primary|Overall Survival||5 years|||months||95% Confidence Interval|Median
746802|NCT00525525|Primary|Unexpected Toxicities During First 2 Cycles of Study Drug|Unexpected severe study-related adverse events|Within 8 weeks of initiating study therapy|||Events|||Number
746803|NCT00525525|Secondary|Progression-free Survival|Progression-free survival was defined from the date of diagnosis to the date that progressive disease was first observed on imaging, or the date at which nonreversible neurologic progression or permanently increased corticosteroid requirement, death from any cause, or early discontinuation of treatment. Imaging guidelines were used to evaluate progression: (i) 25% increase in the sum of products of all measurable lesions over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline; (ii) clear worsening of any assessable disease; (iii) appearance of any new lesion/site; and (iv) clear clinical worsening or failure to return for evaluation as a result of death or deteriorating condition (unless clearly unrelated to this cancer).|Approximately 6 months to 1 year|||months||95% Confidence Interval|Median
746804|NCT00525525|Primary|Overall Survival (OS)|Overall survival was defined from the date of diagnosis to date of death from any cause|Approximately 6-24 months|||months||95% Confidence Interval|Median
746805|NCT00525603|Primary|Overall Participant Response|Overall Response: Complete remission (CR), nodular partial remission (nPR), and partial remission (PR) rates (overall response) in high-risk, previously untreated patients with CLL treated with CFAR. National Cancer Institute - Working Group (NCI-WG) response criteria. CR defined as zero nodes, Liver/spleen not palpable, zero symptoms, polymorphonuclear leukocyte (PMN)>1,500/uL, Platelets >100,000uL, Hemoglobin (untransfused) >11.0g/dL, Lymphocytes <4,000/uL and Bone Marrow Aspirate biopsy <30% lymphocytes with no lymphocyte infiltrate; PR defined as nodes >/= 50% decrease,Liver/spleen >/= 50% decrease, symptoms not applicable, PMN >1,500/uL or >50% improvement from baseline, Platelets 100,000uL or >/=50% decrease improvement from baseline, Hemoglobin (untransfused) >11.0g/dL or >50% improvement from baseline, Lymphocytes >50% decrease and Bone Marrow Aspirate biopsy Not Applicable for PR; with nPR defined same as PR but with <30% lymphocytes with residual disease on biopsy.|Evaluated after 3 courses of 4 week therapy (12 weeks)|Sixty participants were analyzed for response. Four participants did not have a response and one participant was not evaluable.||Participants|||Number
746806|NCT00525629|Primary|Insulin Resistance|HOMA-IR (homeostatic model assessment of insulin resistance) given in units as it is a ratio equation.|4 days|||units on a scale||Standard Deviation|Mean
746807|NCT00525733|Primary|The Primary Outcome of This Study is the Proportion of Patients Having Detectable HIV-1 RNA Using the Single Copy Assay After 48 Weeks of Treatment and the Study Hypothesis is That New Treatment is Better Than the Control Group.||48 weeks|||# subjects without detectable viremia|||Number
746808|NCT00525798|Secondary|Number of Patients With Non-vertebral Fractures|"The secondary outcome was the occurrence or not of a non-vertebral fracture during the 3 year observation period. Non-vertebral fractures of interest were: hip fractures, forearm fractures, humurus fractures, rib fractures and clavicular fractures.
Any new non-vertebral fractures while on-study were recorded. A copy of radiographs confirming the fracture, as well as a copy of the radiologist’s report was to be obtained. A copy of the emergency room discharge letter or a hospital discharge letter was also obtained."|From baseline to month 36|all randomized patients||Participants|||Number
746809|NCT00525798|Primary|Number of Patients With New Vertebral Fractures|"The primary variable was the occurrence or not of a new vertebral fracture during the 3 year observation period. New vertebral fractures were identified from an assessment of x-ray of the lateral spine through time (at baseline and at yearly intervals thereafter).
The outcome is the number of new vertebral fractures from baseline to 36 months."|From baseline to month 36|all patients randomized who received at least one dose of study drug, with the addition of evaluable baseline spine X-ray and at least one follow-up for calculation of vertebral fractures.||Participants|||Number
746810|NCT00525824|Secondary|Percent Change in LDL-C After 6 Weeks Monotherapy|Percent change in LDL-C = (Monotherapy treatment value - Baseline value)/Baseline value*100|Mean of Weeks 4 and 6 on monotherapy (Last observation carried forward)|||Percentage||Standard Deviation|Mean
746811|NCT00525824|Secondary|Percent Change in High-sensitivity C-reactive Protein (Hs-CRP) After 6 Weeks Combination Treatment|Percent change in hs-CRP = (Combination treatment value - Baseline value)/Baseline value*100|Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)|||Percentage||Full Range|Mean
746812|NCT00525824|Secondary|Percent Change in ApoB/ApoA-1 After 6 Weeks Combination Treatment|Percent change in ApoB/ApoA-1 = (Combination treatment value - Baseline value)/Baseline value*100|Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)|||Percentage||Standard Deviation|Mean
746813|NCT00525824|Secondary|Percent Change in Non-HDL-C/HDL-C After 6 Weeks Combination Treatment|Percent change in non-HDL-C/HDL-C = (Combination treatment value - Baseline value)/Baseline value*100|Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)|||Percentage||Standard Deviation|Mean
746814|NCT00525824|Secondary|Percent Change in LDL-C/HDL-C After 6 Weeks Combination Treatment|Percent change in LDL-C/HDL-C = (Combination treatment value - Baseline value)/Baseline value*100|Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)|||Percentage||Standard Deviation|Mean
746818|NCT00525824|Secondary|Percent Change in Non-high-density Lipoprotein Cholesterol (nonHDL-C) After 6 Weeks Combination Treatment|Percent change in nonHDL-C = (Combination treatment value - Baseline value)/Baseline value*100|Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)|||Percentage||Standard Deviation|Mean
746819|NCT00525824|Secondary|Percent Change in Triglycerides (TG) After 6 Weeks Combination Treatment|Percent change in TG = (Combination treatment value - Baseline value)/Baseline value*100|Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)|||Percentage||Standard Deviation|Mean
746820|NCT00525824|Secondary|Percent Change in Total Cholesterol (TC) After 6 Weeks Combination Treatment|Percent change in TC = (Combination treatment value - Baseline value)/Baseline value*100|Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)|||Percentage||Standard Deviation|Mean
746821|NCT00525824|Secondary|Percent Change in High-density Lipoprotein Cholesterol (HDL-C) After 6 Weeks Combination Treatment|Percent change in HDL-C = (Combination treatment value - Baseline value)/Baseline value*100|Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)|||Percentage||Standard Deviation|Mean
746822|NCT00525824|Primary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After 6 Weeks Combination Treatment|Percent change in LDL-C = (Combination treatment value - Baseline value)/Baseline value*100|Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)|||Percentage||Standard Deviation|Mean
746823|NCT00525837|Secondary|Tolerability of Varenicline Measured by Adverse Symptoms Checklist (SAFTEE-SI LCN Modified)||6-8 weeks||||||
746824|NCT00525837|Secondary|Improvement on Patient and Clinician Clinical Global Impression Rating Scale (CGI)||6-8 weeks||||||
746825|NCT00525837|Secondary|Improvement on Snaith-Hamilton Anhedonia Scale||6-8 weeks||||||
746826|NCT00525837|Primary|Change in Quick Inventory of Depressive Symptoms, 16 Question Self-report|"this is a 16-item self report questionnaire that measures depressive symptoms.
Improvement is reported in change in depressive score
score ranges from 0-27, with higher numbers indicating more severe symptom reporting.
change is calculated by baseline plus/minus the value at the later time point"|Baseline and every 2 weeks until 8 weeks or study endpoint|||Units on a scale||95% Confidence Interval|Mean
746827|NCT00525876|Primary|Overall Survival at 100 Days Post Transplant (Number of Surviving Participants)|Overall Survival defined as the number of participants living at day 100 following non-myeloablative allogeneic stem cell transplantation using rituximab, cyclophosphamide, fludarabine as a preparative regimen for participants with advanced or recurrent mantle cell lymphoma.|100 days post transplant|Analysis was per protocol.||participants|||Number
746828|NCT00525902|Primary|Cumulative Endpoint|Improvement in at least one of these criteria without significant worsening in any of them. 1) improvement by 2 or more lines of best-corrected Snellen visual acuity in at least one eye; (2) reduction in dose of systemic corticosteroid or other immunosuppressive therapy by at least 50%; (3) two-step improvement in control of ocular inflammation; and (4) reduction of cystoid macular edema and other inflammatory signs on angiography.|50 Weeks|Participants characterized as clinical responders at 10 weeks were allowed to continue in the study.||participants|||Number
746829|NCT00525902|Primary|Cumulative Endpoint|Improvement in at least one of these criteria without significant worsening in any of them. 1) improvement by 2 or more lines of best-corrected Snellen visual acuity in at least one eye; (2) reduction in dose of systemic corticosteroid or other immunosuppressive therapy by at least 50%; (3) two-step improvement in control of ocular inflammation; and (4) reduction of cystoid macular edema and other inflammatory signs on angiography.|10 weeks|||participants|||Number
746830|NCT00525915|Primary|Pathologic Complete Response Rate|Pathologic Complete Response rate: percentage of participants with response reported as Pathologic complete response (pathCR) following surgery. Once surgery performed, response to therapy judged in surgical specimen with three possible categories reported: 1) Pathologic complete response (no residual cancer in the specimen); 2) <50% of residual cells in the surgical specimen; or 3) >50% of cells in the surgical specimen. Upon recovery from chemoradiation (Chemo), surgery follows approximately 5-6 weeks later with response assessment. Arm A schedule consists of 6 weeks of Chemo +XRT, followed by 5-6 weeks of rest, followed by surgery. Arm B schedule consist of 8 weeks of Chemo, followed by 6 weeks of Chemo +XRT, followed by 5-6 weeks of rest, followed by surgery. In particular, Arm B is 8 weeks longer than Arm A.|Surgery post chemotherapy (approximately 10-11 weeks)|Participants who had surgery were reported for the pathCR rate assessment in this outcome.||percentage of participants|||Number
746831|NCT00526058|Secondary|Device Parameters|"Apheresis Machine Physical parameters; Parameter Description (Abbreviation) Plasmat® Secura Plasma Flow (Plasma Pump) Plasma Pressure 1 (PLP 1) Plasma Pressure 2 (PLP 2) Filtration Pressure 1 (FP 1) Transmembrane Pressure (TMP) Plasmat® Futura Plasma Flow (Plasma Pump) Pressure at Precipitate Filter (PPF) Pressure at Dialysis Filter (PDF) Pressure Drop Across Precipitate Adsorber (PDPA)*
PDPA = PPF - PDF"|Analyzed at specific time points throughout the study from week 0 to week 24.||||||
746832|NCT00526058|Primary|Percent Change of the Pre and Post Treatment Value|The primary study endpoint is the change in percent measurements of the pre-to-post apheresis LDL measurements. Blood samples for LDL-cholesterol determination will be obtained before and after each treatment. The pooled difference between the pre- and post-treatment LDL level for each apheresis machine will be reported as the primary endpoint for the system performance.|Assessment based on LDL-C values obtained pre-and post-treatment, analyzed from week 0 to week 24.|||percentage of change||Standard Deviation|Mean
746833|NCT00526058|Secondary|Clinical Lab Profiles|Blood samples will be obtained for hematology; coagulation, Prothrombin time, , and Inflammatory markers,chemistry (Alkaline phosphatase, blood urea nitrogen, CPK (Creatine phosphokinase, Creatinine, Ferritin, Glucose, Lactate dehydrogenase, Phosphate, and uric acid) and liver functions (Total Protein, Total bilirubin, Alanine Aminotransferase (ALT), Aspartate transaminase (AST); immunoglobulins; complement components; endocrine; and urinalysis (color, specific gravity, wbc (white blood count), rbc (red blood count), urinary dipstick chemistry, and examination of sediment) will be obtained.|Analyzed at specific time points throughout the study from week 0 to week 24.||||||
746834|NCT00526058|Primary|Percent Change in Pre- and Post-treatment Reductions of Low-density Lipoprotein Cholesterol (LDL-C) Levels Between the Approved H.E.L.P. System and the Modified H.E.L.P. System.||Blood samples for LDL-cholesterol determination will be obtained before and after each treatment from week 0 to week 24..||||||
752324|NCT00558272|Secondary|Saracatinib: Minimum Plasma Concentration at Steady State (Css,Min)||Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29|||ng/ml||Full Range|Median
746835|NCT00526097|Secondary|Change From Baseline for Chloride (Normalized Value)|Normalized value: the reported laboratory value is converted by linear transformation to a preferred unit and then linear-transformed with respect to the standard reference range|Baseline and 4 weeks|Treated patients ( = All randomised patients, who took at least one dose of trial medication), who provided data for the underlying outcome measure||mmol/L||Standard Deviation|Mean
746836|NCT00526097|Secondary|Change From Baseline for Potassium (Normalized Value)|Normalized value: the reported laboratory value is converted by linear transformation to a preferred unit and then linear-transformed with respect to the standard reference range|Baseline and 4 weeks|Treated patients ( = All randomised patients, who took at least one dose of trial medication), who provided data for the underlying outcome measure||mmol/L||Standard Deviation|Mean
746837|NCT00526097|Secondary|Change From Baseline for Sodium (Normalized Value)|Normalized value: the reported laboratory value is converted by linear transformation to a preferred unit and then linear-transformed with respect to the standard reference range|Baseline and 4 weeks|Treated patients ( = All randomised patients, who took at least one dose of trial medication), who provided data for the underlying outcome measure||mmol/L||Standard Deviation|Mean
746838|NCT00526097|Secondary|Change From Baseline in the PAC-QoL Overall Score|The PAC-QoL is a 28-item (5-point Likert scale ranging from 0 (none of the time or not at all) to 4 (all of the time or extremely). Single item scores are inverted, if applicable, to ensure that a lower score indicates a better QoL|Baseline and 4 weeks|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Score on a scale||Standard Error|Least Squares Mean
746839|NCT00526097|Secondary|Change From Baseline in the PAC-QoL Subscale 'Satisfaction'|The PAC-QoL is a 28-item (5-point Likert scale ranging from 0 (none of the time or not at all) to 4 (all of the time or extremely). Single item scores are inverted, if applicable, to ensure that a lower score indicates a better QoL|Baseline and 4 weeks|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Score on a scale||Standard Error|Least Squares Mean
746840|NCT00526097|Secondary|Change From Baseline in the PAC-QoL Subscale 'Psychosocial Discomfort'|The PAC-QoL is a 28-item (5-point Likert scale ranging from 0 (none of the time or not at all) to 4 (all of the time or extremely). Single item scores are inverted, if applicable, to ensure that a lower score indicates a better QoL|Baseline and 4 weeks|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Score on a scale||Standard Error|Least Squares Mean
746841|NCT00526097|Secondary|Change From Baseline in the PAC-QoL Subscale 'Physical Discomfort'|The PAC-QoL is a 28-item (5-point Likert scale ranging from 0 (none of the time or not at all) to 4 (all of the time or extremely). Single item scores are inverted, if applicable, to ensure that a lower score indicates a better QoL|Baseline and 4 weeks|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Score on a scale||Standard Error|Least Squares Mean
746842|NCT00526097|Secondary|Change From Baseline in the PAC-QoL Subscale 'Worries and Concerns'|The PAC-QoL is a 28-item (5-point Likert scale ranging from 0 (none of the time or not at all) to 4 (all of the time or extremely). Single item scores are inverted, if applicable, to ensure that a lower score indicates a better QoL|Baseline and 4 weeks|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Score on a scale||Standard Error|Least Squares Mean
746843|NCT00526097|Secondary|Change From Baseline in the SF-36 Physical Component Scale (PCS)|The PCS is a summary scale of the subscales physical functioning, role-physical, bodily pain, and general health. The component scale is norm-based to a standard population. A higher score indicates a better health.|Baseline and 4 weeks|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Score on a scale||Standard Error|Least Squares Mean
746844|NCT00526097|Secondary|Change From Baseline in the SF-36 Mental Component Scale (MCS)|The MCS is a summary scale of the dimensions vitality, social functioning, role-emotional, and mental health. The component scale is norm-based to a standard population. A higher score indicates a better health.|Baseline and 4 weeks|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Score on a scale||Standard Error|Least Squares Mean
746845|NCT00526097|Secondary|Change From Baseline in the SF-36 Dimension 'Mental Health'|The dimension is a sum of 5 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health.|Baseline and 4 weeks|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Score on a scale||Standard Error|Least Squares Mean
746846|NCT00526097|Secondary|Change From Baseline in the SF-36 Dimension 'Role Limitation Due to Emotional Problems'|The dimension is a sum of 3 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health.|Baseline and 4 weeks|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Score on a scale||Standard Error|Least Squares Mean
746847|NCT00526097|Secondary|Change From Baseline in the SF-36 Dimension 'Social Functioning'|The dimension is a sum of 2 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health.|Baseline and 4 weeks|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Score on a scale||Standard Error|Least Squares Mean
786952|NCT00848250|Primary|t-PA (Tissue-type Plasminogen Activator) Antigen||Baseline (prior to surgery) to postoperative day 1|||ng/ml||Standard Error|Mean
746848|NCT00526097|Secondary|Change From Baseline in the SF-36 Dimension 'Vitality'|The dimension is a sum of 4 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health.|Baseline and 4 weeks|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Score on a scale||Standard Error|Least Squares Mean
746849|NCT00526097|Secondary|Change From Baseline in the SF-36 Dimension 'General Health'|The dimension is a sum of 5 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health.|Baseline and 4 weeks|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Score on a scale||Standard Error|Least Squares Mean
746850|NCT00526097|Secondary|Change From Baseline in the SF-36 Dimension 'Bodily Pain'|The dimension is a sum of 2 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health.|Baseline and 4 weeks|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Score on a scale||Standard Error|Least Squares Mean
746851|NCT00526097|Secondary|Change From Baseline in the SF-36 Dimension 'Role Limitation Due to Physical Problems'|The dimension is a sum of 4 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health.|Baseline and 4 weeks|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Score on a scale||Standard Error|Least Squares Mean
746852|NCT00526097|Secondary|Change From Baseline in the SF-36 Dimension 'Physical Functioning'|The dimension is a sum of 10 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health.|Baseline and 4 weeks|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Score on a scale||Standard Error|Least Squares Mean
746853|NCT00526097|Secondary|Number of Participants With Respect to the Final Global Assessment of Tolerability by the Patient|Final global assessment scale range: 1 (good) to 4 (bad), ordinal|4 weeks|Treated patients ( = All randomised patients, who took at least one dose of trial medication), who provided data for the underlying outcome measure||Participants|||Number
746854|NCT00526097|Secondary|Number of Participants With Respect to the Final Global Assessment of Tolerability by the Investigator|Final global assessment scale range: 1 (good) to 4 (bad), ordinal|4 weeks|Treated patients ( = All randomised patients, who took at least one dose of trial medication), who provided data for the underlying outcome measure||Participants|||Number
746855|NCT00526097|Secondary|Number of Participants With Respect to the Final Global Assessment of Efficacy by the Patient|Final global assessment scale range: 1 (good) to 4 (bad), ordinal|4 weeks|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Participants|||Number
746856|NCT00526097|Secondary|Number of Participants With Respect to the Final Global Assessment of Efficacy by the Investigator|Final global assessment scale range: 1 (good) to 4 (bad), ordinal|4 weeks|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Participants|||Number
746857|NCT00526097|Secondary|Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 4 in the Treatment Period in Comparison to Baseline|Reduced / unchanged / increased bothersomeness of abdominal discomfort is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline|Baseline and week 4 in the treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Participants|||Number
746858|NCT00526097|Secondary|Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 3 in the Treatment Period in Comparison to Baseline|Reduced / unchanged / increased bothersomeness of abdominal discomfort is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline|Baseline and week 3 in the treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Participants|||Number
746859|NCT00526097|Secondary|Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 2 in the Treatment Period in Comparison to Baseline|Reduced / unchanged / increased bothersomeness of abdominal discomfort is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline|Baseline and week 2 in the treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Participants|||Number
746860|NCT00526097|Secondary|Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 1 in the Treatment Period in Comparison to Baseline|Reduced / unchanged / increased bothersomeness of abdominal discomfort is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline|Baseline and week 1 in the treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Participants|||Number
746861|NCT00526097|Secondary|Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 4 in the Treatment Period in Comparison to Baseline|Reduced / unchanged / increased bothersomeness of abdominal bloating is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline|Baseline and week 4 in the treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Participants|||Number
746862|NCT00526097|Secondary|Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 3 in the Treatment Period in Comparison to Baseline|Reduced / unchanged / increased bothersomeness of abdominal bloating is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline|Baseline and week 3 in the treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Participants|||Number
746863|NCT00526097|Secondary|Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 2 in the Treatment Period in Comparison to Baseline|Reduced / unchanged / increased bothersomeness of abdominal bloating is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline|Baseline and week 2 in the treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Participants|||Number
746864|NCT00526097|Secondary|Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 1 in the Treatment Period in Comparison to Baseline|Reduced / unchanged / increased bothersomeness of abdominal bloating is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline|Baseline and week 1 in the treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Participants|||Number
746865|NCT00526097|Secondary|Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 4 in the Treatment Period in Comparison to Baseline|Reduced / unchanged / increased bothersomeness of constipation is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline|Baseline and week 4 in the treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Participants|||Number
746866|NCT00526097|Secondary|Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 3 in the Treatment Period in Comparison to Baseline|Reduced / unchanged / increased bothersomeness of constipation is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline|Baseline and week 3 in the treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Participants|||Number
746867|NCT00526097|Secondary|Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 2 in the Treatment Period in Comparison to Baseline|Reduced / unchanged / increased bothersomeness of constipation is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline|Baseline and week 2 in the treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Participants|||Number
746868|NCT00526097|Secondary|Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 1 in the Treatment Period in Comparison to Baseline|Reduced / unchanged / increased bothersomeness of constipation is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline|Baseline and week 1 in the treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Participants|||Number
746869|NCT00526097|Secondary|Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 4 in the Treatment Period in Comparison to Baseline|Improved / unchanged / worsened overall satisfaction is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (A very great deal satisfied) to 4 (Not at all satisfied) at the corresponding week in comparison to baseline|Baseline and week 4 in the treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Participants|||Number
746870|NCT00526097|Secondary|Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 3 in the Treatment Period in Comparison to Baseline|Improved / unchanged / worsened overall satisfaction is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (A very great deal satisfied) to 4 (Not at all satisfied) at the corresponding week in comparison to baseline|Baseline and week 3 in the treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Participants|||Number
746893|NCT00526097|Secondary|Number of Participants Using Rescue Medication at Week 4 in the Treatment Period||Week 4 in the treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Participants|||Number
746871|NCT00526097|Secondary|Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 2 in the Treatment Period in Comparison to Baseline|Improved / unchanged / worsened overall satisfaction is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (A very great deal satisfied) to 4 (Not at all satisfied) at the corresponding week in comparison to baseline|Baseline and week 2 in the treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Participants|||Number
746872|NCT00526097|Secondary|Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 1 in the Treatment Period in Comparison to Baseline|Improved / unchanged / worsened overall satisfaction is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (A very great deal satisfied) to 4 (Not at all satisfied) at the corresponding week in comparison to baseline|Baseline and week 1 in the treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Participants|||Number
746873|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Manual Manoeuvre' at Week 4|The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 4 in treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Score on a scale||Standard Error|Least Squares Mean
746874|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Manual Manoeuvre' at Week 3|The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 3 in treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Score on a scale||Standard Error|Least Squares Mean
746875|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Manual Manoeuvre' at Week 2|The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 2 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Score on a scale||Standard Error|Least Squares Mean
746876|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Manual Manoeuvre' at Week 1|The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 1 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Score on a scale||Standard Error|Least Squares Mean
746877|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Anorectal Obstructions/Blockade' at Week 4|The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 4 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Score on a scale||Standard Error|Least Squares Mean
746878|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Anorectal Obstructions/Blockade' at Week 3|The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 3 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Score on a scale||Standard Error|Least Squares Mean
746879|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Anorectal Obstructions/Blockade' at Week 2|The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 2 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Score on a scale||Standard Error|Least Squares Mean
746880|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Anorectal Obstructions/Blockade' at Week 1|The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 1 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Score on a scale||Standard Error|Least Squares Mean
746881|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Sensation of Incomplete Evacuation' at Week 4|The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 4 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Score on a scale||Standard Error|Least Squares Mean
746882|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Sensation of Incomplete Evacuation' at Week 3|The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 3 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Score on a scale||Standard Error|Least Squares Mean
746883|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Sensation of Incomplete Evacuation' at Week 2|The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 2 in treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Score on a scale||Standard Error|Least Squares Mean
746884|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Sensation of Incomplete Evacuation' at Week 1|The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 1 in treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Score on a scale||Standard Error|Least Squares Mean
746885|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Stool Quality' at Week 4|The score on the 7-point Bristol Stool Form Scale from Type 1 (hard, lumpy stool) to Type 7 (watery stool) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 4 in treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Score on a scale||Standard Error|Least Squares Mean
746886|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Stool Quality' at Week 3|The score on the 7-point Bristol Stool Form Scale from Type 1 (hard, lumpy stool) to Type 7 (watery stool) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 3 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Score on a scale||Standard Error|Least Squares Mean
746887|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Stool Quality' at Week 2|The score on the 7-point Bristol Stool Form Scale from Type 1 (hard, lumpy stool) to Type 7 (watery stool) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 2 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Score on a scale||Standard Error|Least Squares Mean
746888|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Stool Quality' at Week 1|The score on the 7-point Bristol Stool Form Scale from Type 1 (hard, lumpy stool) to Type 7 (watery stool) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 1 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Score on a scale||Standard Error|Least Squares Mean
746889|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Straining' at Week 4|The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 4 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Score on a scale||Standard Error|Least Squares Mean
746890|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Straining' at Week 3|The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 3 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Score on a scale||Standard Error|Least Squares Mean
746891|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Straining' at Week 2|The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 2 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Score on a scale||Standard Error|Least Squares Mean
746892|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Straining' at Week 1|The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 1 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Score on a scale||Standard Error|Least Squares Mean
746894|NCT00526097|Secondary|Number of Participants Using Rescue Medication at Week 3 in the Treatment Period||Week 3 in the treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Participants|||Number
746895|NCT00526097|Secondary|Number of Participants Using Rescue Medication at Week 2 in the Treatment Period||Week 2 in the treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Participants|||Number
746896|NCT00526097|Secondary|Number of Participants Using Rescue Medication at Week 1 in the Treatment Period||Week 1 in the treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Participants|||Number
746897|NCT00526097|Secondary|Number of Participants Using Rescue Medication Over the 4 Weeks Treatment Period||4 weeks|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Participants|||Number
746898|NCT00526097|Secondary|Number of Premature Withdrawals at Week 4 in the Treatment Period||Week 4 in the treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Participants|||Number
746899|NCT00526097|Secondary|Number of Premature Withdrawals at Week 3 in the Treatment Period||Week 3 in the treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Participants|||Number
746900|NCT00526097|Secondary|Number of Premature Withdrawals at Week 2 in the Treatment Period||Week 2 in the treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Participants|||Number
746901|NCT00526097|Secondary|Number of Premature Withdrawals at Week 1 in the Treatment Period||Week 1 in the treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Participants|||Number
746902|NCT00526097|Secondary|Number of Premature Withdrawals Over the 4 Weeks Treatment Period||4 weeks|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Participants|||Number
746903|NCT00526097|Secondary|Number of Participants With a Mean of at Least 3 CSBMs a Week Over the 4 Weeks Treatment Period||4 weeks|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Participants|||Number
746904|NCT00526097|Secondary|Number of Participants With a Mean of at Least 1 CSBM a Day Over the 4 Weeks Treatment Period||4 weeks|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Participants|||Number
746905|NCT00526097|Secondary|Number of Participants With an Increase of at Least 1 CSBM at Week 4 Compared to Baseline||Baseline and week 4 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Participants|||Number
746906|NCT00526097|Secondary|Number of Participants With an Increase of at Least 1 CSBM at Week 3 Compared to Baseline||Baseline and week 3 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Participants|||Number
746907|NCT00526097|Secondary|Number of Participants With an Increase of at Least 1 CSBM at Week 2 Compared to Baseline||Baseline and week 2 in treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Participants|||Number
746908|NCT00526097|Secondary|Number of Participants With an Increase of at Least 1 CSBM at Week 1 Compared to Baseline||Baseline and week 1 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Participants|||Number
746909|NCT00526097|Secondary|Number of Participants With an Increase of at Least 1 in the Mean Number of CSBMs Per Week Over the 4 Weeks Treatment Period Compared to Baseline||Baseline and 4 weeks|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Participants|||Number
746910|NCT00526097|Secondary|Time to the First SBM Following the First Dose of Study Medication (SM)|The time to the first SBM following the first dose of SM was captured by the eDiary. The time was censored by the time of intake of rescue medication (RM), the time of premature discontinuation or the end of treatment whatever was minimal.|Time of first dose of SM up to 4 weeks|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Hours||95% Confidence Interval|Median
746911|NCT00526097|Secondary|Number of SBMs at Week 4|The number of SBMs at week 4 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.|Week 4 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||SBMs per week||Standard Error|Least Squares Mean
746912|NCT00526097|Secondary|Number of SBMs at Week 3|The number of SBMs at week 3 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.|Week 3 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||SBMs per week||Standard Error|Least Squares Mean
746913|NCT00526097|Secondary|Number of SBMs at Week 2|The number of SBMs at week 2 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.|Week 2 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||SBMs per week||Standard Error|Least Squares Mean
746914|NCT00526097|Secondary|Number of SBMs at Week 1|The number of SBMs at week 1 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.|Week 1 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||SBMs per week||Standard Error|Least Squares Mean
746915|NCT00526097|Secondary|Mean Number of SBMs Per Week Over the 4 Weeks Treatment Period|A Spontaneous Bowel Movement (SBM) is a non-rescue medication-induced stool. The number of SBMs in each of the 4 weeks was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer. The sum of the resulting numbers were divided by the number of weeks with data.|4 Weeks|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||SBMs per week||Standard Error|Least Squares Mean
746916|NCT00526097|Secondary|Number of CSBMs at Week 4|The number of CSBMs at week 4 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.|Week 4 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||CSBMs per week||Standard Error|Least Squares Mean
746917|NCT00526097|Secondary|Number of CSBMs at Week 3|The number of CSBMs at week 3 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.|Week 3 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||CSBMs per week||Standard Error|Least Squares Mean
746918|NCT00526097|Secondary|Number of CSBMs at Week 2|The number of CSBMs at week 2 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.|Week 2 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||CSBMs per week||Standard Error|Least Squares Mean
746919|NCT00526097|Secondary|Number of CSBMs at Week 1|The number of CSBMs at week 1 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.|Week 1 in treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||CSBMs per week||Standard Error|Least Squares Mean
746920|NCT00526097|Primary|Mean Number of Complete Spontaneous Bowel Movements (CSBMs) Per Week Over the 4 Weeks Treatment Period|"A Complete Spontaneous Bowel Movement (CSBM) is a complete non-rescue medication-induced stool.
The number of CSBMs in each of the 4 weeks was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer. The sum of the resulting numbers were divided by the number of weeks with data."|4 Weeks|Full Analysis Set (FAS): All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure||CSBMs per week||Standard Error|Least Squares Mean
746921|NCT00526110|Secondary|Median Overall Survival|Overall survival was defined as the time from the start of treatment until death or last follow-up. Kaplan-Meier curve was used to estimate overall survival.|Up to 30 months|||months||Full Range|Median
746922|NCT00526110|Primary|Progression Free Survival|Progression Free Survival (PFS) defined as the time from the first study drug administration until the first day of radiological and/or symptomatic disease progression is documented, or the start of further anticancer therapy or death from any cause, whichever occurs first. Kaplan-Meier curve was used to estimate PFS. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesion.|Assessed from baseline to 30 months|||months||95% Confidence Interval|Median
746923|NCT00526110|Primary|Maximum Tolerated Dose (MTD)|MTD is the highest dose at which 1 or fewer dose limiting toxicities (DLT’s) are observed in 6 patients. DLT defined as any non-hematologic grade III/IV or neutropenia-associated (infection or fever treated in the hospital) toxicity attributable to this therapy. Response evaluated after two 14-day treatments of Docetaxel, 5-Fluorouracil and Oxaliplatin (One cycle = 28 days).|28 days|||mg/m^2|||Number
746924|NCT00526123|Secondary|Reliability of the Catheter|Percentage of study visits in which the median blood flow rate was greater than or equal to 300 mL/min.|35 Weeks|Number of participants was derived from the 'per protocol' population defined as those subjects that were randomized, had the study catheter inserted, and have at least one post baseline measurement for the primary efficacy endpoint.||percentage of study visits||Standard Deviation|Mean
746925|NCT00526123|Secondary|Primary Failure Rate|The percentage of catheters unable to deliver adequate blood flow of at least 300 mL/min for at least 50% of measurements during the first attempted dialysis session.|First dialysis session with study catheter|Number of participants was derived from the 'per protocol' population defined as those subjects that were randomized, had a study catheter inserted, and have at least one post baseline measurement for the primary efficacy endpoint.||percentage of catheters|||Number
746926|NCT00526123|Secondary|Frequency of Clinician Interventions for Catheter Malfunction and Infection|Average number of times clinician intervention was required for either catheter malfunction or infection|35 Weeks|Number of participants is derived from the 'per protocol' population defined as those subjects that were randomized and have at least one post baseline measurement for the primary efficacy endpoint.||events||Standard Deviation|Mean
746927|NCT00526123|Secondary|Average Number of Line Reversals Per Subject|Average number of times the dialysis lines were reversed per subject to deliver dialysis treatments|35 Weeks|Number of participants is derived from the 'per protocol' population defined as those subjects that were randomized and have at least one post baseline measurement for the primary efficacy endpoint.||events||Standard Deviation|Mean
746928|NCT00526123|Primary|First Catheter Induced Complication|% of participants that did not experience a catheter induced complication at the specified Outcome Measure Time Frame.|245 days|Number of participants is derived from the 'per protocol' population defined as those subjects that were randomized and have at least one post baseline measurement for the primary efficacy endpoint.||percentage of participants|||Number
746929|NCT00526123|Primary|First Catheter Induced Complication|% of participants that did not experience a catheter induced complication at the specified Outcome Measure Time Frame.|60 days|Number of participants is derived from the 'per protocol' population defined as those subjects that were randomized and have at least one post baseline measurement for the primary efficacy endpoint.||percentage of participants|||Number
746930|NCT00526123|Secondary|Inadequate Flow Rates Requiring Surgical/Radiological Intervention|Number of events per study group in which the first catheter induced complication was 'inadequate flow requiring surgical/radiological intervention'.|35 weeks|Number of participants is derived from the 'intent to treat' population defined as those subjects that were randomized.||events|||Number
746931|NCT00526123|Primary|First Catheter Induced Complication|% of participants that did not experience a catheter induced complication at the specified Outcome Measure Time Frame.|30 days|Number of participants is derived from the 'per protocol' population defined as those subjects that were randomized and have at least one post baseline measurement for the primary efficacy endpoint.||percentage of participants|||Number
746932|NCT00526162|Secondary|Adverse Events|A total of 70 Adverse Events were reported in 44 subjects.|1 month|||participants|||Number
746933|NCT00526162|Secondary|Describe System Performance|System performance was assessed by reviewing Holter records, Save to disk files and technical observations. Only descriptive statistics were presented,no comparative measure was analyzed. 20 24-hour Holter records and 94 Save to Disk Files were reviewed. 3 minor anomalies were found, and were deemed acceptable. There was no patient safety risk.|1 month|The device performed as intended.||participants|||Number
746934|NCT00526162|Primary|Percentage of Subjects With an Unanticipated Serious Adverse Device Effects at 1-Month Post Implant.|Only subjects implanted with a Consulta device that were followed at least 28 days post-implant, or have had a unanticipated device effect within 28 days after implant were included in the analysis.|1 month|||percentage of participants|||Number
746935|NCT00526188|Secondary|Difference in Precision of Lesion Characterization (Combined Pre- and Post-contrast Minus Pre-contrast MRI) Measured in Percentage Points|Three Blinded Reader performed lesion characterization in pre- and combined pre-/post-contrast MRI image set. Per Blinded Reader/image set combination, precision of lesion characterization was calculated: (number of unique Standard of Reference-matched characterizations detected for the Reader/image set combination)/(number of unique lesion characterizations in Standard of Reference)*100%. Then, difference in precision of lesion characterization for post- minus combined pre-/post-contrast MRI (in percentage points) was calculated for each Blinded Reader.|Post administration assessment of study images (i.e. on the same day of treatment by the investigators and at the end of patient enrollment of the study from 29 September to 18 November 2008 by the Blinded Readers).|All participants from the per protocol set with pre- and combined pre- and post- contrast MRI image sets evaluable for all blinded readers, with at least 1 lesion characterization in the Standard of reference (SOR)||Percentage points||95% Confidence Interval|Mean
746936|NCT00526188|Secondary|Difference in Sensitivity of Lesion Detection in MRI Images (Post-contrast MRI Minus Pre-contrast MRI) Assessed by Investigators Measured in Percentage Points|The on-site investigators performed lesion detection in pre- and post-contrast MRI image sets. Per image set, sensitivity of lesion detection was calculated, as: (number of lesions detected in image set)/(number of lesions in Standard of Reference)*100%. Then, difference in sensitivity of lesion detection for post- minus pre-contrast MRI (in percentage points) was calculated.|Post administration assessment of study images (i.e. on the same day of treatment by the investigators and at the end of patient enrollment of the study from 29 September to 18 November 2008 by the Blinded Readers).|All participants from the per protocol set, with at least 1 lesion in the Standard of Reference (SOR).||Percentage points||95% Confidence Interval|Mean
746937|NCT00526188|Primary|Difference in Sensitivity of Lesion Detection in MRI Images (Post-contrast MRI Minus Pre-contrast MRI) Measured as Percentage Points|Three Blinded Readers performed lesion detection in pre- and post-contrast MRI image sets. Per Blinded Reader/image set combination, sensitivity of lesion detection was calculated, as: (number of lesions detected in the reader/image set combination)/(number of lesions in Standard of Reference)*100%. Then, difference in sensitivity of lesion detection for post- minus pre-contrast MRI images (in percentage points) was calculated for each Blinded Reader.|Post administration assessment of study images (i.e. on the same day of treatment by the investigators and at the end of patient enrollment of the study from 29 September to 18 November 2008 by the Blinded Readers).|All participants from the per protocol set with pre- and post-contrast MRI image sets evaluable for all blinded readers, with at least 1 lesion in the Standard of Reference (SOR)||Percentage points||95% Confidence Interval|Mean
746938|NCT00526227|Secondary|Adverse Events|A total of 62 Adverse Events were reported in 43 subjects.|1 Month|||participants|||Number
746939|NCT00526227|Secondary|Describe System Performance|System performance was assessed by reviewing Holter records, Save to disk files and technical observation. Only descriptive statistics were presented, no comparative measure was analyzed. 21 24-hour digital Holter records were review. 140 Save to Disk Files was reviewed. No anomalies were found. The device performed as intended.|1 month|||participants|||Number
791385|NCT00885482|Secondary|Number of Patients With Viral Load Lower Than 50 Copies/mL at 48 Weeks at the Intention to Treat Analysis||48 weeks||||||
746940|NCT00526227|Primary|Percentage of Subjects With an Unanticipated Serious Adverse Device Effects at 1-Month Post Implant.|Only subjects implanted with a Secura device that were followed at least 28 days post-implant, or have had a unanticipated device effect within 28 days after implant were included in the analysis.|1 month|Seventy-nine subjects completed at least one-month (28 days)of follow-up post-implant and were included in the analysis. One subject died prior to the 1-month follow-up.||Percentage of participants|||Number
746941|NCT00526292|Primary|Treatment Efficacy as Defined by Complete or Partial Remission||3 Months following treatment|||participants|||Number
746942|NCT00526331|Primary|Length of Hospital Stay (LOS) by Participant|Length of hospital stay of arterial pressure-based cardiac output (APCO) monitor participants versus the participants using the global standard care guided by esophageal Doppler, measured in days.|From baseline (first day of hospital stay) to release from hospital (anticipate 5 days minimally)|Study terminated by sponsor without analysis due to technical reasons.||days|||Number
746943|NCT00526474|Post-Hoc|Kaplan-Meier Estimate of the Percentage of Participants Who Had Any Revascularization Performed Within 3 Years From Randomization|The time (in days) from study start to the first occurrence of any revascularization was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who had any revascularization performed within 3 years from randomization.|up to 3 years|Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA||Percentage of Participants|||Number
746944|NCT00526474|Post-Hoc|Kaplan-Meier Estimate of the Percentage of Participants Who Had a UH-VCIN Within 3 Years From Randomization|The time (in days) from study start to the first occurrence of a UH-VCIN was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who had a UH-VCIN within 3 years from randomization.|up to 3 years|Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA||Percentage of Participants|||Number
746945|NCT00526474|Post-Hoc|Kaplan-Meier Estimate of the Percentage of Participants Who Died From Any Cause Within 3 Years From Randomization|The time (in days) from study start to death from any cause was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who died from any cause within 3 years from randomization.|up to 3 years|Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA||Percentage of Participants|||Number
746946|NCT00526474|Post-Hoc|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced a Stroke Within 3 Years From Randomization|The time (in days) from study start to first experience of a stroke was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced a stroke within 3 years from randomization.|up to 3 years|Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA||Percentage of Participants|||Number
746947|NCT00526474|Post-Hoc|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced UCR Within 3 Years From Randomization|The time (in days) from study start to the first occurrence of UCR was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced UCR within 3 years from randomization.|up to 3 years|Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA||Percentage of Participants|||Number
746948|NCT00526474|Post-Hoc|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced an MI Within 3 Years From Randomization|The time (in days) from study start to the first occurrence of an MI was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced an MI within 3 years from randomization.|up to 3 years|Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA||Percentage of Participants|||Number
746949|NCT00526474|Post-Hoc|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death Within 3 Years From Randomization|The time (in days) from study start to the CV death (if reported) was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death within 3 years from randomization.|up to 3 years|Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA||Percentage of Participants|||Number
752325|NCT00558272|Secondary|Saracatinib: Maximum Plasma Concentration at Steady State (Css,Max)||Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29|||ng/ml||Full Range|Median
746950|NCT00526474|Post-Hoc|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death, MI, Stroke, Any Revascularization, or UH-VCIN Within 3 Years From Randomization|The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: CV death, MI, stroke, any revascularization, or UH-VCIN. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death, MI, stroke, any revascularization procedure, or UH-VCIN within 3 years from randomization.|up to 3 years|Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA||Percentage of Participants|||Number
746951|NCT00526474|Post-Hoc|Kaplan-Meier Estimate of the Percentage of Participants Who Died From Any Cause, or Experienced an MI, Stroke, or Any Revascularization Within 3 Years From Randomization|The time (in days) from study start to death from any cause or the first occurrence of any of the following clinical outcomes was recorded: MI, stroke, or any revascularization procedure . A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who died from any cause, or experienced an MI, stroke, or any revascularization within 3 years from randomization.|up to 3 years|Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA||Percentage of Participants|||Number
746952|NCT00526474|Post-Hoc|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death, MI, Stroke, UCR, or UH-VCIN Within 3 Years From Randomization|The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: CV death, MI, stroke, UCR, or UH-VCIN . A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death, MI, stroke, UCR, or UH-VCIN within 3 years from randomization.|up to 3 years|Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA||Percentage of Participants|||Number
746953|NCT00526474|Post-Hoc|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death or an MI Within 3 Years From Randomization|The time (in days) from study start to the occurrence of CV death or first occurrence of an MI. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death or MI within 3 years from randomization.|up to 3 years|Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA||Percentage of Partcipants|||Number
746954|NCT00526474|Post-Hoc|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Death From Any Cause, MI, Stroke, or UCR Within 3 Years From Randomization|The time (in days) from study start to the occurrence of any of the following clinical outcomes was recorded: death from any cause, MI, stroke, or UCR. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who experienced death from any cause, MI, stroke, or UCR within 3 years from randomization.|up to 3 years|Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA||Percentage of Participants|||Number
746955|NCT00526474|Post-Hoc|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Clinically Significant Bleeding Within 3 Years From Randomization|Adverse events were categorized as “bleeding events” if the intensity, frequency, or type of the event was other or more than would be normally expected in the given situation (eg, mild nosebleed in a person who does not normally have nosebleeds, greater bruising than expected for a given injury, greater volume of blood loss than expected for a given procedure). The investigator graded the intensity of bleeding events according to the TIMI Study Group criteria as major, minor or other. “Clinically Significant Bleeding” was defined as the composite of TIMI Major bleeding, TIMI Minor bleeding, or bleeding that required unplanned medical or surgical treatment or unplanned laboratory evaluation even if it did not meet the criteria for TIMI major or minor bleeding. The Kaplan-Meier estimate reports the percentage of participants who experienced clinically significant bleeding within 3 years from randomization.|up to 3 years|Intended Label Safety Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA who received at least 1 dose of study drug||Percentage of Participants|||Number
746956|NCT00526474|Post-Hoc|Kaplan-Meier Estimate of the Percentage of Participants Who Met GUSTO Moderate or Severe Bleeding Criteria Within 3 Years From Randomization|Adverse events were categorized as “bleeding events” if the intensity, frequency, or type of the event was other or more than would be normally expected in the given situation (eg, mild nosebleed in a person who does not normally have nosebleeds, greater bruising than expected for a given injury, greater volume of blood loss than expected for a given procedure). The investigator graded the intensity of bleeding events according to the GUSTO cooperative group criteria as follows: Mild , Moderate or Severe and the grading was adjudicated by the CEC. The Kaplan-Meier estimate reports the percentage of participants who experienced GUSTO moderate or severe bleeding within 3 years from randomization.|up to 3 years|Intended Label Safety Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA who received at least 1 dose of study drug||Percentage of Participants|||Number
747416|NCT00529763|Secondary|Mean Apparent Volume of Distribution (Vz/F) of Dasatinib Following 70 mg BID and 100 QD Dose Administration||Day 1 (0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours postdose), Day 8 (0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12 hours postdose)|Number of treated participants with measurement at time point||mL/h||Standard Deviation|Mean
746957|NCT00526474|Post-Hoc|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death, MI, or Stroke Within 3 Years From Randomization|The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: CV death, MI, or stroke. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death, MI, or stroke within 3 years from randomization.|up to 3 years|Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA||Percentage of Participants|||Number
746958|NCT00526474|Post-Hoc|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death, MI, Stroke, or UCR Within 3 Years From Randomization|The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: CV death, MI, stroke, or UCR. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death, MI, stroke, or UCR within 3 years from randomization.|up to 3 years|Intended Label Population: all enrolled participants with coronary arterial disease (CAD) or peripheral arterial disease (PAD) and no history of a stroke or transient ischemic attack (TIA)||Percentage of Participants|||Number
746959|NCT00526474|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Had Any Revascularization Performed Within 3 Years From Randomization|The time (in days) from study start to the first occurrence of a revascularization was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who had any revascularization performed within 3 years from randomization.|up to 3 years|ITT Population, defined as all participants who were randomly assigned to a treatment arm.||Percentage of Participants|||Number
746960|NCT00526474|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Had a UH-VCIN Within 3 Years From Randomization|The time (in days) from study start to the first occurrence of an UH-VCIN was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who had a UH-VCIN within 3 years from randomization.|up to 3 years|ITT Population, defined as all participants who were randomly assigned to a treatment arm.||Percentage of Participants|||Number
746961|NCT00526474|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Died From Any Cause Within 3 Years From Randomization|The time (in days) from study start to death from any cause was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who died from any cause within 3 years from randomization.|up to 3 years|ITT Population, defined as all participants who were randomly assigned to a treatment arm.||Percentage of Participants|||Number
746962|NCT00526474|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced a Stroke Within 3 Years From Randomization|The time (in days) from study start to first experience of a stroke was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced a stroke within 3 years from randomization.|up to 3 years|ITT Population, defined as all participants who were randomly assigned to a treatment arm.||Percentage of Participants|||Number
746963|NCT00526474|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced UCR Within 3 Years From Randomization|The time (in days) from study start to the first occurrence of UCR was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced UCR within 3 years from randomization.|up to 3 years|ITT Population, defined as all participants who were randomly assigned to a treatment arm.||Percentage of Participants|||Number
746964|NCT00526474|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced an MI Within 3 Years From Randomization|The time (in days) from study start to the first occurrence of an MI was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced an MI within 3 years from randomization.|up to 3 years|ITT Population, defined as all participants who were randomly assigned to a treatment arm.||Percentage of Participants|||Number
747591|NCT00530842|Secondary|Static Lung Volumes (Percent)|Trough RV/TLC (Residual Volume over Total Lung Capacity) after 8 weeks (measured by bodyphlethysmography)|8 weeks|FAS using imputed values||Percent of RV over TLC||Standard Error|Mean
746965|NCT00526474|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death Within 3 Years From Randomization|The time (in days) from study start to CV death (if reported) was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death within 3 years from randomization.|up to 3 years|ITT Population, defined as all participants who were randomly assigned to a treatment arm.||Percentage of Participants|||Number
746966|NCT00526474|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death, MI, Stroke, Any Revascularization, or UH-VCIN Within 3 Years From Randomization|The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: CV death, MI, stroke, any revascularization, or UH-VCIN. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death, MI, stroke, any revascularization procedure, or UH-VCIN within 3 years from randomization.|up to 3 years|ITT Population, defined as all participants who were randomly assigned to a treatment arm.||Percentage of Participants|||Number
746967|NCT00526474|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Died From Any Cause, or Experienced an MI, Stroke, or Any Revascularization Within 3 Years From Randomization|The time (in days) from study start to death from any cause or the first occurrence of any of the following clinical outcomes was recorded: MI, stroke, or any revascularization procedure . A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who died from any cause, or experienced an MI, stroke, or any revascularization within 3 years from randomization.|up to 3 years|ITT Population, defined as all participants who were randomly assigned to a treatment arm.||Percentage of Participants|||Number
746968|NCT00526474|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death, MI, Stroke, UCR, or Urgent Hospitalization for Vascular Cause of Ischemic Nature (UH-VCIN) Within 3 Years From Randomization|The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: CV death, MI, stroke, UCR or UH-VCIN. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death, MI, stroke, UCR, or UH-VCIN within 3 years from randomization.|up to 3 years|ITT Population, defined as all participants who were randomly assigned to a treatment arm.||Percentage of Participants|||Number
746969|NCT00526474|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death or an MI Within 3 Years From Randomization|The time (in days) from study start to the occurrence of CV death or MI. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death or MI within 3 years from randomization.|up to 3 years|ITT Population, defined as all participants who were randomly assigned to a treatment arm.||Percentage of Participants|||Number
746970|NCT00526474|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Death From Any Cause, MI, Stroke, or UCR Within 3 Years From Randomization|The time (in days) from study start to the occurrence of any of the following clinical outcomes was recorded: death from any cause, MI, stroke, or UCR. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who experienced death from any cause, MI, stroke, or UCR within 3 years from randomization.|up to 3 years|ITT Population, defined as all participants who were randomly assigned to a treatment arm.||Perentage of Participants|||Number
746971|NCT00526474|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Clinically Significant Bleeding Within 3 Years From Randomization|Adverse events were categorized as “bleeding events” if the intensity, frequency, or type of the event was other or more than would be normally expected in the given situation (eg, mild nosebleed in a person who does not normally have nosebleeds, greater bruising than expected for a given injury, greater volume of blood loss than expected for a given procedure). The investigator graded the intensity of bleeding events according to the Thrombolysis in Myocardial Infarction (TIMI) Study Group criteria as major, minor or other. “Clinically Significant Bleeding” was defined as the composite of TIMI Major bleeding, TIMI Minor bleeding, or bleeding that required unplanned medical or surgical treatment or unplanned laboratory evaluation even if it did not meet the criteria for TIMI major or minor bleeding. The Kaplan-Meier estimate reports the percentage of participants who experienced clinically significant bleeding within 3 years from randomization.|up to 3 years|As Treated Population, which included all participants who received at least 1 dose of study medication.||Percentage of Participants|||Number
747058|NCT00527423|Secondary|Mean Change From Baseline of Original Study in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score of Study Eye - Observed Values|Defined study baseline range of ETDRS Best Corrected Visual Acuity of: letter score of 73 to 25 (20/40 to 20/320) in the study eye; a higher score represents better functioning.|Baseline of original study to Wk 156|||letters read||Standard Deviation|Mean
746972|NCT00526474|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Met Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) Moderate or Severe Bleeding Criteria Within 3 Years From Randomization|Adverse events were categorized as “bleeding events” if the intensity, frequency, or type of the event was other or more than would be normally expected in the given situation (eg, mild nosebleed in a person who does not normally have nosebleeds, greater bruising than expected for a given injury, greater volume of blood loss than expected for a given procedure). The investigator graded the intensity of bleeding events according to the GUSTO cooperative group criteria as follows: Mild , Moderate or Severe and the grading was adjudicated by the CEC. The Kaplan-Meier estimate reports the percentage of participants who experienced GUSTO moderate or severe bleeding within 3 years from randomization.|up to 3 years|As Treated Population, which included all participants who received at least 1 dose of study medication.||Percentage of Participants|||Number
746973|NCT00526474|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death, MI, or Stroke Within 3 Years From Randomization|The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: CV death, MI, or stroke. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death, MI, or stroke within 3 years from randomization.|up to 3 years|ITT Population, defined as all participants who were randomly assigned to a treatment arm.||Percentage of Participants|||Number
746974|NCT00526474|Primary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Cardiovascular (CV) Death, Myocardial Infarction (MI), Stroke, or Urgent Coronary Revascularization (UCR) Within 3 Years From Randomization|The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: CV death, MI, stroke, or UCR. A Clinical Endpoints Committee (CEC) reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death, MI, stroke, or UCR within 3 years from randomization.|up to 3 years|Intent to Treat (ITT) Population, defined as all participants who were randomly assigned to a treatment arm.||Percentage of Participants|||Number
746975|NCT00526630|Secondary|The 5-item EuroQoL (EQ-5D) Quality of Life Generic Instrument Between Groups at 12 and 27 Weeks.|The EQ-5D comprises five questions on mobility, self care, pain, usual activities, and psychological status with three possible answers for each item (1=no problem, 2=moderate problem, 3=severe problem; see appendix). A summary index with a maximum score of 1 can be derived from these five dimensions by conversion with a table of scores. The range is from 0 to 100, with 100 indicating the best health status.|Week 12 and 27|||units on a scale||Standard Deviation|Mean
746976|NCT00526630|Secondary|The Epworth Sleepiness Scale (ESS) Between Groups at 12 and 27 Weeks|The Epworth Sleepiness Scale (ESS) is a scale intended to measure daytime sleepiness that is measured by use of a very short questionnaire. The questionnaire asks the subject to rate his or her probability of falling asleep on a scale of increasing probability from 0 to 3 for eight different situations that most people engage in during their daily lives, though not necessarily every day. The scores for the eight questions are added together to obtain a single number. A number in the 0–9 range is considered to be normal while a number in the 10–24 range indicates excessive daytime sleepiness. Higher scores imply worse sleepiness.|Week 12 and 27|||units on a scale||Standard Deviation|Mean
746977|NCT00526630|Secondary|Montgomery–Åsberg Depression Rating Scale (MADRS) Between Groups at 12 and 27 Weeks.|MADRS is a questionnaire used to measure the severity of depressive episodes in patients with mood disorders. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60|Week 12 and 27|||units on a scale||Standard Deviation|Mean
746978|NCT00526630|Secondary|Freezing of Gait Questionnaire (FOGQ) Scores Between Groups at 12 and 27 Weeks.|FOGQ is a questionnaire that quantifies severity of gait and falls. It contains 16 items with a 0-4 severity scale for each, for a range of 0 (normal) to 64 (most severe impairment).|Week 12 and 27|||units on a scale||Standard Deviation|Mean
746979|NCT00526630|Secondary|Duration of Freezing and Shuffling Episodes Between Groups at 12 and 27 Weeks.|Freezing and shuffling are measures of ambulatory impairment.|Week 12 and 27|||hours||Standard Deviation|Mean
746980|NCT00526630|Primary|The Primary Outcome Measure Was Change in Gait Velocity Between Groups at 12 and 27 Weeks.|"Gait velocity is a measure of distance over time in the on state. This will be measured by the GAITRite System, which is an electronic walkway utilized to measure the temporal (timing) and spatial (two dimension geometric position) parameters of its pressure activated sensors."|Week 12 and 27|||centimeters/second||Standard Deviation|Mean
746981|NCT00526630|Primary|The Primary Outcome Measure Was Change in a Gait Stride Length Between Groups at 12 and 27 Weeks.|"Gait stride length is the distance between two consecutive steps in the on state. This will be measured by the GAITRite System, which is an electronic walkway utilized to measure the temporal (timing) and spatial (two dimension geometric position) parameters of its pressure activated sensors."|Week 12 and 27|||centimeters||Standard Deviation|Mean
746982|NCT00526630|Secondary|The Unified Parkinson Disease Rating Scale (UPDRS) Between Groups at 12 and 27 Weeks|Patients will have a mild to severe gait disturbance with score >1 on the motor subscale of the Unified Parkinson’s disease rating scale (UPDRS) but without need for a continuous ambulatory aid such as walker or wheelchair (Hoehn & Yahr 2-3). The highest score possible for the UPDRS is 108 which indicates severe motor impairment. The lowest score for the UPDRS is 0 which indicates no motor impairment.|At week 12 and 27|||units on a scale||Standard Deviation|Mean
747059|NCT00527423|Secondary|Frequency (Number of Injections)|Frequency (number of injections) of PRN treatment from baseline of this study to week 152 (end of treatment).|Baseline of this study to Wk 152|A total of 1116 PRN injections were administered into the study eyes of 135 participants between baseline of this study to Week 152 (end of treatment). Of the 157 enrolled participants, 22 received no injections, and 15 received 1 injection.||Injections||Full Range|Median
746983|NCT00526669|Secondary|Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points|Blood samples were collected for the evaluation of WBC count. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For WBCs: G 1 (<LLN to 3000/mm^3 of blood plasma [bp]), mild; G 2 (<3000 to 2000/mm^3 of bp), moderate; G 3 (<2000 to 1000/mm^3 of bp), severe; G 4 (<1000/mm^3 of bp), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.|Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy|Safety Population. Only those participants with data available at the specified time points were evaluated.||participants|||Number
746984|NCT00526669|Secondary|Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points|Blood samples were collected for the evaluation of platelet count. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For platelet count: G 1 (<LLN to 75000/mm^3 of blood plasma [bp]), mild; G 2 (<75000 to 50000/mm^3 of bp), moderate; G 3 (<50000 to 25000/mm^3 of bp), severe; G 4 (<25000/mm^3 of bp), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.|Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy|Safety Population. Only those participants with data available at the specified time points were evaluated.||participants|||Number
746985|NCT00526669|Secondary|Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points|Blood samples were collected for the evaluation of total neutrophils. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For neutrophils: G 1 (<LLN to 1500/millimeters cubed [mm^3] of blood plasma [bp]), mild; G 2 (<1500 to 1000/mm^3 of bp), moderate; G 3 (<1000 to 500/mm^3 of bp), severe; G 4 (<500/mm^3 of bp), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.|Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy|Safety Population. Only those participants with data available at the specified time points were evaluated.||participants|||Number
746986|NCT00526669|Secondary|Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points|Blood samples were collected for the evaluation of lymphocytes. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For lymphocytes: G 1, mild; G 2, moderate; G 3, severe; G 4, life threatening/disabling; G 5, death related to AE; ranges were provided by local laboratories. Change from Baseline was measured as any grade increase (AGI), increase to G 3 (ItoG3), and increase to G 4 (ItoG4). Worst-case on-therapy reflects the most severe change at any time point measured post treatment.|Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy|Safety Population. Only those participants with data available at the specified time points were evaluated.||participants|||Number
746987|NCT00526669|Secondary|Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points|Blood samples were collected for the evaluation of hemoglobin. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For hemoglobin: G 1 (<LLN to 10 g/dL), mild; G 2 (<10.0 to 8.0 g/dL), moderate; G 3 (<8.0 to 6.5 g/dL), severe; G 4 (<6.5 g/dL), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.|Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy|Safety Population. Only those participants with data available at the specified time points were evaluated.||participants|||Number
746988|NCT00526669|Secondary|Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points|Blood samples were collected for sodium evaluation. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of each AE severity. For sodium (high and low, respectively): G 1 (>ULN to 150 mmol/L; <LLN to 130 mmol/L), mild; G 2 (>150 to 155 mmol/L; value not available), moderate; G 3 (>155 to 160 mmol/L; <130 to 120 mmol/L), severe; G 4 (>160 mmol/L; <120 mmol/L), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.|Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy|Safety Population. Only those participants with data available at the specified time points were evaluated.||participants|||Number
746989|NCT00526669|Secondary|Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points|Blood samples were collected for magnesium evaluation. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For magnesium (high and low, respectively): G 1 (>ULN to 3.0 mg/dL; <LLN to 1.2 mg/dL), mild; G 2 (value not available; <1.2 to 0.9 mg/dL), moderate; G 3 (>3.0 to 8.0 mg/dL; <0.9 to 0.7 mg/dL), severe; G 4 (>8.0 mg/dL; <0.7 mg/dL), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.|Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy|Safety Population. Only those participants with data available at the specified time points were evaluated.||participants|||Number
747060|NCT00527423|Primary|Number of Participants With Adverse Events (AE)|Number of participants with AEs summarized by category|Baseline of this study to Wk 152|||participants|||Number
791386|NCT00885482|Secondary|Time to Virological Failure at Survival Analysis||48 weeks||||||
746990|NCT00526669|Secondary|Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points|Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For potassium (high and low [per blood samples], respectively): G 1 (>ULN to 5.5 millimoles per liter [mmol/L]; <LLN to 3.0 mmol/L), mild; G 2 (>5.5 to 6.0 mmol/L; value not available), moderate; G 3 (>6.0 to 7.0 mmol/L; <3.0 to 2.5 mmol/L), severe; G 4 (>7.0 mmol/L; <2.5 mmol/L), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.|Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy|Safety Population. Only those participants with data available at the specified time points were evaluated.||participants|||Number
746991|NCT00526669|Secondary|Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points|Blood samples were collected for the evaluation of glucose. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For glucose (high and low, respectively): G 1 (>ULN to 160 mg/dL; <LLN to 55 mg/dL), mild; G 2 (>160 to 250 mg/dL; <55 to 40 mg/dL), moderate; G 3 (>250 to 500 mg/dL; <40 to 30 mg/dL), severe; G 4 (>500 mg/dL; <30 mg/dL), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.|Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy|Safety Population. Only those participants with data available at the specified time points were evaluated.||participants|||Number
746992|NCT00526669|Secondary|Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points|Blood samples were collected for the evaluation of creatinine. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For creatinine: G 1 (>ULN to 1.5x ULN), mild; G 2 (>1.5 to 3.0x ULN), moderate; G 3 (>3.0 to 6.0x ULN), severe; G 4 (>6.0x ULN), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.|Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy|Safety Population. Only those participants with data available at the specified time points were evaluated.||participants|||Number
746993|NCT00526669|Secondary|Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points|Blood samples were collected for calcium evaluation. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For calcium (low and high, respectively): G 1 (<LLN to 8.0 mg/dL; >ULN to 11.5x ULN), mild; G 2 (<8.0 to 7.0 mg/dL; >11.5 to 12.5 ULN), moderate; G 3 (<7.0 to 6.0 mg/dL; >12.5 to 13.5 mg/dL), severe; G 4 (<6 mg/dL; >13.5 mg/dL), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.|Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy|Safety Population. Only those participants with data available at the specified time points were evaluated.||participants|||Number
746994|NCT00526669|Secondary|Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points|Blood samples were collected for the evaluation of total bilirubin. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For total bilirubin: G 1 (>ULN to 1.5x ULN), mild; G 2 (>1.5 to 3.0x ULN), moderate; G 3 (>3.0 to 10.0x ULN), severe; G 4 (>10.0x ULN), life threatening/disabling; G 5 (value not available), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.|Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy|Safety Population. Only those participants with data available at the specified time points were evaluated.||participants|||Number
746995|NCT00526669|Secondary|Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points|Blood samples were collected for the evaluation of ALT. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For ALT: G 1 (>ULN to 2.5x ULN), mild; G 2 (>2.5 to 5.0x ULN), moderate; G 3 (>5.0 to 20.0x ULN), severe; G 4 (>20.0x ULN), life threatening/disabling; G 5 (value not available), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.|Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy|Safety Population. Only those participants with data available at the specified time points were evaluated.||participants|||Number
746996|NCT00526669|Secondary|Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points|Blood samples were collected for the evaluation of AST. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For AST: G 1 (>ULN to 2.5x ULN), mild; G 2 (>2.5 to 5.0x ULN), moderate; G 3 (>5.0 to 20.0x ULN), severe; G 4 (>20.0x ULN), life threatening/disabling; G 5 (value not available), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.|Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy|Safety Population. Only those participants with data available at the specified time points were evaluated.||participants|||Number
747061|NCT00527475|Secondary|The Number of Days to Retreatment. The Total Number of Treatments Given Over One Year. The Percentage of Patients With More Than a 15 Letter Increase in Vision at 12 Months. The Mean Change in Macular Volume as Measured by OCT at 3, 6, and 12 Months.||1 year||||||
746997|NCT00526669|Secondary|Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points|Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For ALP: G 1 (upper limit of normal [ULN] to 2.5x ULN), mild; G 2 (>2.5 to 5.0x ULN), moderate; G 3 (>5.0 to 20.0x ULN), severe; G 4 (>20.0x ULN), life threatening/disabling; G 5 (value not available), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.|Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy|Safety Population. Only those participants with data available at the specified time points were evaluated.||participants|||Number
746998|NCT00526669|Secondary|Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points|Toxicity was measured in grades (AE severity) per National Cancer Institute Common Toxicity Criteria for Adverse Event (NCI CTCAE) version (v) 3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For albumin (per blood samples): G 1 (<lower limit of normal [LLN] to 3 grams per deciliter [g/dL]), mild; G 2 (<3 to 2 g/dL), moderate; G 3 (<2 g/dL), severe; G 4 (value not available), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.|Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy|Safety Population: all participants who entered the study and received at least one dose of lapatinib. Only those participants with data available at the specified time points were evaluated.||participants|||Number
746999|NCT00526669|Secondary|Number of Participants in the Indicated Categories for Best Overall Response (BOR)|Best overall response was evaluated by the investigator based on RECIST criteria: CR; PR; Stable Disease (SD), defined as no sufficient shrinkage to qualify for PR, no sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started; PD, defined as at least a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of >= 1 new lesions; Unknown, defined as participants who do not have CR, PR, SD, or PD.|From Baseline (Day 0) until disease progression or death due to any cause (up to approximately 85 weeks)|ITT Population||participants|||Number
747000|NCT00526669|Secondary|Duration of Response|Duration of response is defined as the time from the first documented evidence of tumor response (CR or PR) until the first documented sign of disease progression or death due to any cause, whichever came first.|From date of first documented evidence of response until the date of first documented sign of disease progression or death due to any cause (up to approximately 78 weeks)|ITT Population. Duration of response was estimated for only the subset of participants who had response. Duration of response was censored for participants who did not have an event before data cut off. The last available assessment prior to the data cut off was used for censored participants.||weeks||95% Confidence Interval|Median
747001|NCT00526669|Secondary|Time to Response|Time to response is defined as the time from the initial treatment until the first documented evidence of CR (disappearance of all TLs and non-TLs and the appearance of no new lesions) or PR (>= a 30% decrease in the sum of the longest diameter of TLs, taking as reference the Baseline sum longest diameter) (whichever status was recorded first). Time to response data are presented as cumulative incidence estimate, which is defined as the time from the initial treatment until crude hazard probability of the occurrence of a particular event is reached to a particular point.|Baseline (Day 0) until first documented evidence of response (up to approximately 60 weeks)|ITT Population. Time to response was censored for participants who did not have an event before data cut off. The last available assessment prior to the data cut off was used for censored participants.||weeks||Inter-Quartile Range|Median
747002|NCT00526669|Secondary|Time to Progression (All Deaths Due to Non-PD Are Treated as Competing Risk)|Time to progression is defined as the time from the initial treatment (first dose) until the first documented radiological symptomatic sign of disease progression. Time to progression data are presented as cumulative incidence estimate, which is defined as the time from the initial treatment until crude hazard probability of occurrence of a particular event is reached to a particular point. All factors that hinder the observation of the event are defined as competing risks.|From Baseline (Day 0) until disease progression or death due to any cause (up to approximately 85 weeks)|ITT Population. Time to progression was censored for participants who did not have an event before data cut off. The last available assessment prior to the data cut off was used for censored participants.||weeks||Inter-Quartile Range|Median
747003|NCT00526669|Secondary|Time to Progression (All Deaths Are Treated as Competing Risk)|Time to progression is defined as the time from the initial treatment (first dose) until the first documented radiological symptomatic sign of disease progression. Time to progression data are presented as cumulative incidence estimate, which is defined as the time from the initial treatment until crude hazard probability of the occurrence of a particular event is reached to a particular point. All factors that hinder the observation of the event are defined as competing risks.|From Baseline (Day 0) until disease progression or death due to any cause (up to approximately 85 weeks)|ITT Population. Time to progression was censored for participants who did not have an event before data cut off. The last available assessment prior to the data cut off was used for censored participants.||weeks||Inter-Quartile Range|Median
747004|NCT00526669|Secondary|Overall Survival (OS)|Overall survival is defined as the time from the initial treatment until death due to any cause. A death occurring during the study is defined as a death occurring during treatment or within 30 days of the last administration of study medication.|From Baseline (Day 0) until death due to any cause evaluated at approximately 12 months (up to approximately 100 weeks)|ITT Population. OS was censored for participants who did not have an event before data cut off. The last available assessment prior to the data cut off was used for censored participants.||weeks||95% Confidence Interval|Median
747062|NCT00527475|Primary|The Percentage of Patients With Less Than 15 Letters of ETDRS Visual Loss at 12 Months.||1 year|Fifty-six participants completed the full 12 month study. Four subjects did not return for the 12 month visit. No patients terminated the study due to adverse events.||percentage of participants|||Number
747005|NCT00526669|Secondary|PFS|PFS is defined as the time from the initial treatment until the first observation of disease progression or death due to any cause. The date of documented disease progression was defined as the earliest date of radiographic disease assessment progression or symptomatic progression, whichever came first. For participants who did not die/progress, survival was censored at the time of the last assessment (or contact).|From Baseline (Day 0) until disease progression or death due to any cause (up to approximately 85 weeks)|ITT Population. PFS was censored for participants who did not have an event before data cut off. The last available assessment prior to the data cut off was used for censored participants.||weeks||95% Confidence Interval|Median
747006|NCT00526669|Primary|Percentage of Participants (Par.) With 5-month Progression-free Survival (PFS)|5-month (mo.) PFS was defined as the percentage of par. who were alive/progression free for 5 months from the time of initial treatment. PFS is defined as the time from the initial treatment until the first observation of disease progression (DP)/death due to any cause; the percentage of par. whose follow-up ended or was ongoing was reported. DP is defined as symptomatic progression or the appearance of >=1 NL and/or unequivocal progression of existing non-TLs, and a >=20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since treatment started.|From initial treatment up to 24 weeks (next available assessment after the 5-month assessment for progressive disease)|ITT Population. PFS was censored for participants who did not have an event before data cut off. The last available assessment prior to the data cut off was used for censored participants.||percentage of participants|||Number
747007|NCT00526669|Primary|Response Rate (Measured as the Percentage of Participants With Response [Complete Response or Partial Response])|Response is defined as documented evidence of complete response (CR) or partial response (PR). The investigator evaluated response based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete response is defined as the disappearance of all target lesions (TLs) and non-TLs and the appearance of no new lesions (NLs). Partial response for TLs is defined as >= a 30% decrease in the sum of the longest diameter (LD) of TLs, taking as a reference the Baseline sum LD. For non-TLs it is defined as the persistence of 1 or more non-TL and no new TLs or non-TLs.|From Baseline (Day 0) until disease progression or death due to any cause evaluated every 6 or 12 weeks (up to approximately 85 weeks)|ITT Population||percentage of participants|||Number
747008|NCT00526669|Primary|Change From Start of Run-in Period in Biomarker Expression Levels at Day 0|Participants were analyzed for intratumoral expression levels of genes involved in the 5-fluorouracil (FU) pathway and lapatinib-targeted genes. Change in biomarker expression levels was calculated as the levels measured after the lapatinib Run-in Period (Baseline) of the study minus the levels measured at the start of monotherapy (Day -7). EGFR, epidermal growth factor receptor; HER, human epidermal growth factor receptor. Data are presented as ratios of the normalized gene expression of the target gene to that of beta actin.|evaluated at baseline and after 7 days of study treatment|Intent-to-Treat (ITT) Population: all participants who entered the study and received at least one dose of lapatinib. Only those participants contributing viable samples were analyzed. Different participants contributed samples for different biomarkers.||ratio||Full Range|Median
747009|NCT00526799|Secondary|Duration of Stable Disease|To determine duration of stable disease, in months|From enrollment until treatment discontinuation. Participants may remain on study drug indefinitely|||months||95% Confidence Interval|Median
747010|NCT00526799|Secondary|Clinical Benefit|To determine the rate of clinical benefit defined as the percentage of patients experiencing an objective response or a CA125 response.|From enrollment until treatment discontinuation. Participants may remain on study drug indefinitely|||percentage of particpants||95% Confidence Interval|Number
747011|NCT00526799|Secondary|Progression-free Survival|To determine the progression-free survival of patients treated with Sorafenib plus Topotecan.|From enrollment until treatment discontinuation. Participants may remain on study drug indefinitely|||months||95% Confidence Interval|Median
747012|NCT00526799|Primary|Percentage of Participants With Response|"To assess response in patients with recurrent or resistant epithelial ovarian cancer treated with Sorafenib plus Topotecan. Reponse evaluated per RECIST criteria where:
Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started"|Disease assessments were conducted on the 8th week (Cycle 2, Week 4) and every eight weeks there after, until treatment discontinuation|||percentage of participants|||Number
747013|NCT00526799|Primary|Maximum Tolerated Dose (MTD)|An initial 3 patients will be enrolled at dose level 1. If all 3 patients in dose level 1 complete the first cycle of therapy without a dose limiting toxicity (DLT), 3 patients will be enrolled at dose level 2. If 0 of 3 or 1 of 6 patients in dose level 2 experience a DLT, all subsequent patients will be enrolled in the Phase II cohort at dose level 2. If 2 of the first 3 or 2 of the total 6 patients experience DLT at dose level 2, then dose level 1 will be considered the MTD and used in the second phase.|Each participant was treated at their assigned dose level on 28 day cycles until disease progression or unacceptable toxicity. Participants were evaluated for toxicity every two weeks.|Of the 16 patients enrolled in the phase I study, five were not evaluable for MTD determination due to intercurrent illnesses interfering with toxicity assessment or withdrawal and were replaced or excluded.||mg/day|||Number
747021|NCT00526994|Primary|Quality of Life, Mental Health Composite|Assessed with the Quality of Life SF-12 v.2 (Ware, Kosinski, Turner-Bowker, & Gandek, 2002). This instrument has 12 items measuring eight subscales of mental and physical health—general health, physical functioning, role limitations due to physical health problems, role limitations due to emotional problems, bodily pain, vitality (energy/fatigue), social functioning, and mental health (psychological distress)—during the past 4 weeks. These subscales are combined to form a physical health composite scale and a mental health composite scale. Each scale is standardized to have a mean of 50 and a standard deviation of 10 for the U.S. population with a possible range from 0 to 100; higher scores represent a better health state.|past 30 days|||units on a scale||95% Confidence Interval|Mean
747022|NCT00526994|Secondary|Disability|days lost from housework|one year follow-up|||days||95% Confidence Interval|Mean
747023|NCT00526994|Secondary|Utilization of Health Care|number of ambulatory care visits|during past year|||visits||95% Confidence Interval|Mean
747024|NCT00526994|Primary|Quality of Life, Physical Health Composite|Assessed with Quality of Life SF-12 V.2 (Ware, Kosinski,Turner-Bowker, & Gandek, 2002). This instrument has 12 items measuring eight subscales of mental and physical health—general health, physical functioning, role limitations due to physical health problems, role limitations due to emotional problems, bodily pain, vitality (energy/fatigue), social functioning, and mental health (psychological distress)—during the past 4 weeks. These subscales are combined to form a physical health composite scale and a mental health composite scale. Each scale is standardized to have a mean of 50 and a standard deviation of 10 for the U.S. population with a possible range from 0 to 100; higher scores represent a better health state.|at one-year follow-up|||units on a scale||95% Confidence Interval|Mean
747025|NCT00527072|Secondary|Number of Patients Achieved Psoriasis Area Activity Index (PASI) 50 Response at Week 26||Week 26|This analysis is based on all observed mITT patients. The treatment failures will be classified as not achieving a PASI 50, 75, 90, or 100 response at all visits after the date of treatment failure. For non-treatment failure patients who did not have a PASI score at the visit due to other reasons, their data at that visit will not be imputed.||participants|||Number
747026|NCT00527072|Secondary|Number of Patients Achieved Psoriasis Area Activity Index (PASI) 50 Response at Week 10|A PASI 50 responder is defined as a patient who has achieved at least a 50% improvement in the overall PASI score from baseline. PASI is an index used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 to 72. A score less than 10 signifies a mixture of mild and moderate disease; a score greater than 10 but less than or equal to 30 signifies moderate disease; and a score greater than 30 signifies severe disease.|Week 10|Analysis is based on observed mITT (modified Intent to Treat) patients. Treatment failures are classified as not achieving a PASI 50, 75, 90, or 100 response at all visits after the date of treatment failure. For non-treatment failure patients who did not have a PASI score at the visit due to other reasons, will not have data imputed at that visit.||participants|||Number
747027|NCT00527072|Primary|Number of Patients Who Achieve a Physician Global Assessment (PGA) Score of Minimal (1) or Clear (0)|Patients who did not have a PGA score at Week 10 will be treated as not having achieved a PGA score of minimal (1) or clear (0) at Week 10. Specifically, treatment failures prior to Week 10 will be classified as not having a minimal (1) or clear (0).|Week 10|This analysis is based on the evaluable population that includes the all enrolled patients who received at least one infliximab infusion, and had a baseline PGA score greater than 1.||participants|||Number
747028|NCT00527098|Primary|Mortality||From hospital arrival up to an average of 3.5 weeks|Analysis was per protocol.||participants|||Number
747029|NCT00527111|Secondary|KRAS Mutation Rate|Percentage of Participants with KRAS mutation.|5 years|ITT population with KRAS test||percentage of participants with mutation|||Number
747030|NCT00527111|Secondary|Recurrence-free Survival (RFS) Rate at 5 Years|RFS is measured from the date of randomization to the date of first documented disease recurrence or date of death, whichever comes first. If a patient neither recurrences nor dies, this patient will be censored at the date of last contact.|5 years|ITT population||probability of recurrence-free survival||95% Confidence Interval|Number
747031|NCT00527111|Secondary|5- Year Overall Survival (OS) Rate|Overall survival is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the date of last contact.|5 years|ITT population||probability of overall survival||95% Confidence Interval|Number
747032|NCT00527111|Secondary|To Determine Objective Response Rate (ORR) Based on RECIST Local Recurrence-free Survival in These Patient Groups; Overall and Recurrence-free Survival in These Cohorts.|Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.|5 years|Evaluable Population||percentage of participants||95% Confidence Interval|Number
747033|NCT00527111|Primary|Percentage of Pathologic Response Rate (pCR) With 95% Confidence Interval.|A pathologic complete response (pCR) is defined as no pathologic evidence of invasive disease at the primary site in the bowel wall or in examined mesorectal tissue and/or lymph nodes.|5 years|Post surgery population||percentage of participants||95% Confidence Interval|Number
747034|NCT00527124|Secondary|Overall Survival|Analyzed with standard K-M methodology.|The time from registration date until death from any cause, assessed up to 52 weeks||||||
747035|NCT00527124|Secondary|Time to Progression|Analyzed with standard K-M methodology. Both point and 95% CI estimates of the median and other statistics (e.g., the 3-month rate, 6-month rate, etc.) will be computed from the censored distribution of TTP. These point and CI estimates will be reported for all patients combined, and separately for each treatment arm.|The time from registration date until documented clinical disease progression, or until date of death, whichever occurs first, assessed up to 52 weeks||||||
747036|NCT00527124|Secondary|Partial and Complete Response Rate Evaluated by the RECIST Criteria|Will be analyzed with standard Kaplan-Meier (K-M) methodology. Both point and 95% CI estimates of the median and other statistics (e.g., the 3-month rate, 6-month rate, etc.) will be computed from the censored distribution of each of these two TTE endpoints.|Up to 52 weeks||||||
747037|NCT00527124|Secondary|Prostate-specific Antigen (PSA) Response and PSA Control Duration in Accordance With the Prostate Specific Antigen Working Group|Will be analyzed with standard Kaplan-Meier (K-M) methodology. Both point and 95% CI estimates of the median and other statistics (e.g., the 3-month rate, 6-month rate, etc.) will be computed from the censored distribution of each of these two TTE endpoints.|Up to 52 weeks||||||
747038|NCT00527124|Primary|6-month Progression-free Survival (PFS) Proportion|The proportion of patients on each treatment arm who survive ≥ 6.00 months progression-free|Followed for 52 weeks at 3 month intervals after coming off treatment, time period equal to the length of treatment + up to 12 months|Per protocol. 30 subjects on Arm I and 28 subjects on Arm II accrued for analysis of the primary endpoint of 6 mths PFS proportion. PFS is obtainable on all 58 participants enrolled, however 1 subject enrolled on Arm I withdrew before receiving any treatment, hence cannot be included for AE analysis and reporting, AE results involve 29 subjects.||percentage of patients||95% Confidence Interval|Number
747039|NCT00527319|Primary|Proportion of Subjects With a Positive Change From Baseline to Week 4 in Grip Strength||4 weeks|||participants|||Number
747040|NCT00527319|Primary|Proportion of Subjects With a Positive Change From Baseline to Week 4 in Lean Body Mass||4 weeks|||participants|||Number
747041|NCT00527332|Secondary|Health-related Economy.||Within 6 months after the surgery||||||
747042|NCT00527332|Secondary|The Stress Coping Ability Impact on Postoperative Symptoms and Recovery.||Within 6 months after the surgery||||||
747043|NCT00527332|Secondary|Sick Leave.||Within 6 months after the surgery||||||
747044|NCT00527332|Secondary|Quality of Life and QALYs (Quality Adjusted Life Years).||Within 6 months after the surgery||||||
747045|NCT00527332|Secondary|Complications and Complication Rates.||Within 6 months after the surgery||||||
747046|NCT00527332|Secondary|Postoperative Consumption of Analgesics and Antiemetics.||Within 6 months after surgery||||||
747047|NCT00527332|Secondary|Occurrence and Degree of Postoperative Symptoms.||Within 6 months after the surgery||||||
747048|NCT00527332|Primary|Duration of Hospital Stay.|Duration of hospital stay defined as time from start anesthesia to leaving the hospital|Within 6 months after surgery|Participants who completed the study were analyzed||Hours||Full Range|Median
747049|NCT00527397|Primary|Self-Monitoring Blood Glucose Levels: Change From Baseline|Self-monitoring blood glucose levels obtained at each observation point minus that at baseline.|One year|This endopoint was not analyzed because of small numbers of subjects due to early termination||milligram/millilitre||Standard Deviation|Mean
747050|NCT00527397|Secondary|Insulin Antibody Levels : Change From Baseline|Insulin antibody levels obtained at each observation point minus that at baseline. The end of treatment values were calculated each subject's last observed value up to 26 weeks.|Baseline, Week 6, Week 12, End of treatment|Includes all subjects who received at least one dose of study drug. Number of subjects with evaluable data presented as n=type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus Using Insulin, Type 2 Diabetes Mellitus Not Using Insulin, respectively.||microunit/milliliter||Standard Deviation|Mean
747051|NCT00527397|Secondary|The Values of Forced Expiratory Volume at 1 Second/Forced Vital Capacity:Change From Baseline|Pulmonary function test(forced expiratory volume at 1 second/forced vital capacity) obtained at each observation point minus that at baseline. The end of treatment values were calculated each subject's last observed value up to 26 weeks.|Baseline, Week 1, Week 2, Week 6, Week 12, Week26, End of treatment|Included all subjects who had a baseline forced expiratory volume at 1 second value, had at least one-post baseline forced expiratory volume at 1 second values, and received at least one dose of study drug.||liter/liter||Standard Deviation|Mean
747052|NCT00527397|Secondary|The Values of Forced Vital Capacity:Change From Baseline|pulmonary function test(forced vital capacity) obtained at each observation point minus that at baseline. The end of treatment values were calculated each subject's last observed value up to 26 weeks.|Baseline, Week 1, Week 2, Week 6, Week 12, Week 26, End of treatment|Included all subjects who had a baseline forced expiratory volume at 1 second value, had at least one-post baseline forced expiratory volume at 1 second values, and received at least one dose of study drug.||liter||Standard Deviation|Mean
747053|NCT00527397|Secondary|The Values of Forced Expiratory Volume at 1 Second:Change From Baseline|Pulmonary function test(forced expiratory volume at 1 second) obtained at each observation point minus that at baseline. The end of treatment values were calculated each subject's last observed value up to 26 weeks.|Beseline, Week 1, Week 2, Week 6, Week 12, Week 26|Included all subjects who had a baseline forced expiratory volume at 1 second value, had at least one-post baseline forced expiratory volume at 1 second values, and received at least one dose of study drug.||liter||Standard Deviation|Mean
747054|NCT00527397|Secondary|The Incidence of Hypoglycaemia at the Cumulative Doses of Inhaled Insulin|Number of hypoglycemic events per subject-month. Subject-month=(number of days from the first day of study treatment to the last day of active treatment + 1 day lag)/30.44|0 month to 12 months|Includes all subjects who received at least one dose of study drug. Number of subjects with evaluable data presented as n=type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus Using Insulin, Type 2 Diabetes Mellitus Not Using Insulin, respectively.||events / subject-month|||Number
747055|NCT00527397|Secondary|The Value of Fasting Plasma Glucose:Change From Baseline|Fasting plasma glucose levels obtained at each observation point minus that at baseline. The end of treatment values were calculated each subject's last observed value up to 26 weeks.|Baseline, Week 6, Week 12, Week 26|Includes all subjects who received at least one dose of study drug. Number of subjects with evaluable data presented as n=type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus Using Insulin, Type 2 Diabetes Mellitus Not Using Insulin, respectively.||milligram/millilitre||Standard Deviation|Mean
747056|NCT00527397|Secondary|The Values of Hemoglobin A1c:Change From Baseline|Hemoglobin A1c levels obtained each observation point minus that at baseline. The end of treatment values were calculated each subject's last observed value up to 26 weeks.|Baseline, Week 6, Week 12, Week 26, End of treatment|Includes all subjects who received at least one dose of study drug. Number of subjects with evaluable data presented as n=type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus Using Insulin, Type 2 Diabetes Mellitus Not Using Insulin, respectively.||percent||Standard Deviation|Mean
747057|NCT00527397|Secondary|Daily Inhaled Insulin Dose|The mean of daily inhaled insulin dose. The dose of inhaled insulin was adjusted based on the results of self-monitoring of blood glucose before each meal.The end of treatment values were calculated each subject's last observed value up to 26 weeks.|Up to 26 weeks|Includes all subjects who received at least one dose of study drug. Number of subjects with evaluable data presented as n=type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus Using Insulin, Type 2 Diabetes Mellitus Not Using Insulin, respectively.||milligram||Standard Deviation|Mean
747080|NCT00527514|Secondary|Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 10 mg + Olmesartan 40 mg Group|Change from study baseline in cuff systolic pressure (as measured by an Omron device) to the end of the treatment period. The Last Observation Carried Forwarded (LOCF) approach was used for the analysis.|Baseline to end end of week 12|ITT (efficacy cohort)||mm Hg||Standard Error|Mean
747081|NCT00527514|Secondary|Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 5mg + Olmesartan 40 mg Group|Change from study baseline in cuff systolic pressure (as measured by an Omron device) to the end of the treatment period. The Last Observation Carried Forwarded (LOCF) approach was used for the analysis.|Baseline to end of week 9|ITT (efficacy cohort)||mm Hg||Standard Error|Mean
747082|NCT00527514|Secondary|Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 5mg + Olmesartan 20 mg Group.|Change from study baseline in cuff systolic pressure (as measured by an Omron device) to the end of the treatment period. The Last Observation Carried Forwarded (LOCF) approach was used for the analysis.|Baseline to end of week 6|ITT (efficacy cohort)||mm Hg||Standard Error|Mean
747083|NCT00527514|Secondary|Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 5mg Group.|Change from study baseline in cuff systolic pressure (as measured by an Omron device) to the end of the treatment period. The Last Observation Carried Forwarded (LOCF) approach was used for the analysis.|Baseline to end of week 3|ITT (efficacy cohort)||mm Hg||Standard Deviation|Mean
747084|NCT00527514|Secondary|Change From Baseline in Daytime and Nighttime Ambulatory Systolic Blood Pressure||Baseline to 12 weeks|The ambulatory blood pressure monitoring (ABPM) subset were subjects who received at least one dose of active study medication and had a baseline ABPM and end of study ABPM measurement.This = 172 participants.||mm Hg||Standard Deviation|Mean
747085|NCT00527514|Primary|Change From Baseline in Mean 24-hour Systolic Blood Pressure Measured by Ambulatory Monitoring||Baseline to 12 Weeks|The ambulatory blood pressure monitoring (ABPM) subset were subjects who received at least one dose of active study medication and had a baseline ABPM and end of study ABPM measurement.This = 172 participants.||mm Hg||Standard Deviation|Mean
747086|NCT00527566|Secondary|Efficacy- Exacerbation Rate|Quantified the exacerbation rate (total number of exacerbations per day) of the participants during treatment with mepolizumab and without treatment. Exacerbations were characterized as any worsening of clinical disease requiring an increase of systemic corticosteroid therapy (e.g. prednisone) for asthma, respiratory symptoms, or underlying vasculitis.|Treatment period (12 weeks)|||Exacerbation rate (Exacerbations/day)|||Number
747088|NCT00527566|Secondary|Evaluate Overall Positive Change in Churg-Strauss Syndrome Via the Measures Outlined in Study Aims|The Asthma Control Questionnaire (ACQ) was one measure used to assess the prevalence of asthma symptoms the participant was having during the study. It is a series of 7 questions assessing how often, over the past two weeks, the participant wakes up from their asthma, how bad their symptoms were, etc. The greater the prevalence of symptoms, the higher the score. Each of the 7 questions is scored 0-6. The total score is calculated by adding the individual question scores and dividing the sum by 7.|20 weeks|||units on a scale||Full Range|Mean
747089|NCT00527566|Secondary|Steroid Dosing During Trial||20 weeks|||Prednisone mg/day||Full Range|Mean
747090|NCT00527566|Primary|Number of Participants With Indicated Side Effects|Side effects experienced by participants 1 to 2 days after Mepolizumab infusion.|Participants were followed for the duration of the study, approximately 44 weeks|||Participants|||Number
747091|NCT00527592|Primary|Comfort Immediately After Dosing|Comfort was assessed by the patient and recorded on a scale of 0 to 100, with 0 = perfect comfort and 100 = worse discomfort imaginable.|5 seconds|Intent to treat: All patients who received test article and completed the trial.||Units on a scale|Participants|Standard Deviation|Mean
747092|NCT00527605|Secondary|Change From Baseline in Qmax at Month 3|Change from baseline was calculated as Qmax at Month 3 minus Qmax at baseline. Qmax is the peak urinary flow measured by a uroflow meter.|Baseline and Month 3|ITT Population. Some participants were missing Month 3 measurements.||ml/s||Standard Deviation|Mean
747093|NCT00527605|Secondary|Change From Baseline in Qmax at Month 6|Change from baseline was calculated as Qmax at Month 6 minus Qmax at baseline. Qmax is the peak urinary flow measured by a uroflow meter.|Baseline and Month 6|ITT Population. Some participants were missing Month 6 measurements.||milliliters/second (ml/s)||Standard Deviation|Mean
747094|NCT00527605|Secondary|Percent Change From Baseline in Qmax at Month 3|Percent change from baseline was calculated as Qmax at Month 3 minus Qmax at baseline, divided by baseline Qmax and multiplied by 100. Qmax is the peak urinary flow measured by a uroflow meter.|Baseline and Month 3|ITT Population. Some participants were missing Month 3 measurements.||percent change||Standard Deviation|Mean
747095|NCT00527605|Secondary|Percent Change From Baseline in Maximum Urinary Flow Rate (Qmax) at Month 6|Percent change from baseline was calculated as Qmax at Month 6 minus Qmax at baseline, divided by baseline Qmax and multiplied by 100. Qmax is the peak urinary flow measured by a uroflow meter.|Baseline and Month 6|ITT Population. Some participants were missing Month 6 measurements.||percent change||Standard Deviation|Mean
747096|NCT00527605|Secondary|Change From Baseline in the AUA-SI Score at Month 3|Change from baseline was calculated as the AUA-SI score at month 3 minus the baseline score. AUA-SI is a self-administered questionnaire that assesses the severity of benign prostate hyperplasia symptoms. Scores range from 0 to 35; mild, 0-7; moderate, 8-19; severe, 20-35.|Baseline and Month 3|ITT Population. Some participants were missing Month 3 measurements.||points on a scale||Standard Deviation|Mean
747097|NCT00527605|Secondary|Change From Baseline in the AUA-SI Score at Month 6|Change from baseline was calculated as the AUS-SI score at month 6 minus the baseline score. AUA-SI is a self-administered questionnaire that assesses the severity of benign prostatic hyperplasia symptoms. Scores range from 0 to 35; mild, 0-7; moderate, 8-19; severe, 20-35.|Baseline and Month 6|ITT Population. Some participants were missing Month 6 measurements.||points on a scale||Standard Deviation|Mean
747098|NCT00527605|Secondary|Percent Change From Baseline in the AUA-SI Score at Month 3|Percent change from baseline is calculated as the AUA-SI score at month 3 minus the baseline AUA-SI score, divided by the baseline score and multiplied by 100. AUA-SI is a self-administered questionnaire that assesses the severity of benign prostatic hyperplasia symptoms. Scores range from 0 to 35; mild, 0-7; moderate, 8-19; severe, 20-35.|Baseline and Month 3|ITT Population. Some participants were missing Month 3 measurements.||percent change||Standard Deviation|Mean
747099|NCT00527605|Secondary|Percent Change From Baseline in the American Urological Association Symptom Index (AUA-SI) Score at Month 6|Percent change from baseline is calculated as the AUA-SI score at month 6 minus the baseline AUA-SI score, divided by the baseline score and multiplied by 100. AUA-SI is a self-administered questionnaire that assesses the severity of benign prostatic hyperplasia symptoms. Scores range from 0 to 35; mild, 0-7; moderate, 8-19; severe, 20-35.|Baseline and Month 6|ITT Population. Some participants were missing Month 6 measurements.||percent change||Standard Deviation|Mean
747100|NCT00527605|Secondary|Change From Baseline in the Serum DHT at Month 3|Change from baseline was calculated as the value of DHT at Month 3 minus the baseline value.|Baseline and Month 3|ITT Population. Some participants were missing Month 3 measurements.||pg/ml||Standard Deviation|Mean
747101|NCT00527605|Secondary|Change From Baseline in the Serum DHT at Month 6|Change from baseline was calculated as the value of DHT at Month 6 minus the baseline value.|Baseline and Month 6|ITT Population. Some participants were missing Month 6 measurements.||picograms/milliliter (pg/ml)||Standard Deviation|Mean
747102|NCT00527605|Secondary|Percent Change From Baseline in the Serum DHT at Month 3|Percent change from baseline was calculated as the DHT at Month 3 minus the value at baseline, divided by the baseline value and multiplied by 100.|Baseline and Month 3|ITT Population. Some participants were missing Month 3 measurements.||percent change||Standard Deviation|Mean
747103|NCT00527605|Secondary|Percent Change From Baseline in the Serum Dihydrotestosterone (DHT) at Month 6|Percent change from baseline was calculated as serum DHT at month 6 minus the value at baseline ,divided by the baseline value and multiplied by 100.|Baseline and Month 6|ITT Population. Some participants were missing Month 6 measurements.||percent change||Standard Deviation|Mean
747104|NCT00527605|Secondary|Change From Baseline in the Prostate Volume at Month 3|Change from baseline was calculated as the prostate volume at Month 3 minus the volume at baseline. Prostate volume is measured by transrectal ultrasound.|Baseline and Month 3|ITT Population. Some participants were missing Month 3 measurements.||cubic centimeters||Standard Deviation|Mean
747105|NCT00527605|Secondary|Change From Baseline in the Prostate Volume at Month 6|Change from baseline was calculated as the prostate volume at Month 6 minus the volume at baseline. Prostate volume was measured by transrectal ultrasound.|Baseline and Month 6|ITT Population. Some participants were missing Month 6 measurements.||cubic centimeters||Standard Deviation|Mean
747202|NCT00528112|Secondary|Average Total Cervical Score – Year 3|Cervical mucus samples were analyzed to determine any effects of progesterone on the cervical mucus. Range of score: 0 (high contraceptive efficacy) to 12 (low contraceptive efficacy)|For six weeks in the second half of Year 3|A subset of women from the full analysis set||Scores on a scale||Standard Deviation|Mean
747106|NCT00527605|Secondary|Percent Change From Baseline in the Prostate Volume at Month 3|Percent change from baseline was calculated as the prostate volume at Month 3 minus the volume at baseline, divided by the prostate volume at baseline and multiplied by 100. Prostate volume was measured by transrectal ultrasound.|Baseline and Month 3|ITT Population. Some participants were missing Month 3 measurements.||percent change in volume||Standard Deviation|Mean
747107|NCT00527605|Primary|Percent Change From Baseline in the Prostate Volume at Month 6|Percent change from baseline was calculated as the prostate volume at Month 6 minus the volume at baseline, divided by the prostate volume at baseline and multiplied by 100. Prostate volume was measured by transrectal ultrasound.|Baseline and Month 6|Intent-to-Treat (ITT) Population: all participants who were randomized to study treatment (after the 4-week placebo run-in) and received at least one dose of study treatment. Some participants were missing Month 6 measurements.||percent change in volume||Standard Deviation|Mean
747108|NCT00527618|Secondary|Sub-Study: To Evaluate the Kinetics of Plasma HIV-1 Decline Over the First Three Days of High-dose Valacyclovir Administration.|Plasma HIV-1 RNA was measured one day prior to, at initiation, and at 6, 24, 48, and 72 hours after initiating valacyclovir. Measurements at 24, 48, and 72 hours were used to determine the rate of HIV-1 RNA decline.|72 hours|In April 2010, we invited participants, including those who already completed the study, to participate in the substudy. Two participants had plasma HIV-1 RNA <40 copies/mL at the time of valacyclovir initiation and were excluded from analysis.||log10 copies/mL/day||95% Confidence Interval|Mean
747109|NCT00527618|Secondary|The Safety of Valacyclovir 1 Gram Orally Twice Daily in HIV-1 Seropositive Persons.||12 weeks||||||
747110|NCT00527618|Secondary|The Effect of Valacyclovir 1 g Twice Daily Compared With Acyclovir 400 mg Twice Daily on the Quantity of Genital HSV Detected During Shedding Episodes.|HSV DNA was quantitated from daily self-collected genital swabs for the four weeks of each drug intervention. The quantity of genital HSV DNA present, when HSV DNA was detected, was compared.|The first four weeks of each intervention|Of the 34 participants who were randomized, 6 participants did not contribute to both arms of the study. The final analysis set therefore included 28 participants.||log10 copies/mL||Full Range|Median
747111|NCT00527618|Secondary|The Effect of Valacyclovir 1 Gram Twice Daily Compared to Acyclovir 400 mg Twice Daily on the Percentage of Days With Genital Herpes Lesions.|The percentage of days with genital herpes lesions was determined by the combined diary days in which genital lesions were recorded divided by the combined number of diary days for participants in the first four weeks of each drug intervention, multiplied by 100.|26 weeks (12 weeks per drug intervention)|Of the 34 participants who were randomized, 6 participants did not contribute to both arms of the study. The final analysis set therefore included 28 participants.||percentage of days with genital lesions|||Number
747112|NCT00527618|Primary|The Genital HSV Shedding Rate While on 400 mg Twice Daily of Acyclovir Versus 1000 mg Twice Daily of Valacyclovir.|HSV DNA quantitated from daily self-collected genital swabs for the first four weeks of each drug intervention. The shedding rate was determined by the combined number of swabs with HSV detected divided by the combined number of swabs collected from participants, multiplied by 100.|The first four weeks of each intervention|Of the 34 participants who were randomized, 6 participants did not contribute to both arms of the study. The final analysis set therefore included 28 participants.||percentage of swabs collected with HSV|||Number
747113|NCT00527618|Primary|The Quantity of HIV-1 RNA in Plasma While on 400 mg Twice Daily of Acyclovir Versus 1000 mg Twice Daily of Valacyclovir.|Weekly measurements of plasma HIV-1 RNA on each drug were compared. The primary analysis was of the average difference in plasma HIV-1 RNA on valacyclovir and acyclovir as determined by a linear mixed model. The median of the average per-participant plasma HIV-1 RNA levels on valacyclovir and valacyclovir is also listed.|26 weeks (12 weeks per drug intervention)|Of the 34 participants who were randomized, 6 participants did not contribute to both arms of the study. The final analysis set therefore included 28 participants. 27 participants had plasma HIV-1 RNA levels available for analysis, since samples for one participant were persistently inhibited.||log10 copies/mL||Full Range|Median
747114|NCT00527722|Primary|Number of Participants With Absence of Pneumothoraces|Treatment Success defined as absence of pneumothoraces to measure the effects of the hydrogel plug in three follow-up radiographic assessment (x-rays post procedure by 0-60 minutes, 24 hours and 30 days).|X-Rays at 0-60 minutes, 24 hours and 30 days|Intent-to-treat (ITT) population of all subjects who were randomized.||Participants|||Number
747146|NCT00527787|Primary|Number of Participants With Gastric Ulcer Confirmed by Endoscopy|The primary efficacy endpoint was the number of subjects with gastric ulcers at any time throughout 6 months of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter (measured by close application of open endoscopic biopsy forceps) with unequivocal crater depth. A subject is considered to have completed the study if all scheduled assessments up through the 6 month visit have been performed or if the endpoint of gastric ulcer confirmed by endoscopy has been reached.|6 months|Intent to Treat (ITT) Population||Participants|||Number
747147|NCT00527826|Secondary|Mean Total Costs (Related to COPD) Per Participant|"Total costs include costs for hospitalization, medication, and visits to/by physician. Medications that were used as required were assumed to be used every second day."|Baseline through Week 52|ITT Population||Euros per participant||Standard Deviation|Mean
747137|NCT00527748|Primary|Change in Range of Motion|Participants randomized into ARM stretching device group will experience less ankle stiffness and an increased range of motion after using the stretching device, as compared to the control group receiving traditional physiotherapy.|Ten weeks|No participant data or results are available as the investigator left the institution without making them or any analysis available.|||||
747138|NCT00527787|Secondary|Mean Change From Baseline on Satisfaction of the Severity of Dyspepsia Assessment (SODA) Subscales|Mean Change in Satisfaction on SODA Assessment. Questions/statements to rate about satisfaction/dissatisfaction with their present level of abdominal discomfort. Question 1: 4-point scale range 0 (extremely unhappy) to 4 (extremely happy), statement 2 (I feel satisfied with my health with regard to abdominal discomfort) & statement 3 (I am pleased because my abdominal discomfort seems under control) on a 5 point scale (definitely true to definitely false) & question 4 rated how pleased subjects were with abdominal discomfort on a 10 point scale. Total satisfaction composite range: 2-23|baseline to 6 Months|Intent to Treat (ITT) Population||Units on SODA Subscale||Standard Error|Least Squares Mean
747139|NCT00527787|Secondary|Mean Change From Baseline on Non-Pain Symptoms of the Severity of Dyspepsia Assessment (SODA) Subscales|Change from Baseline of Non-Pain Symptoms on the SODA Assessment. There are 7 categories about the non-pain symptoms: burping/beching, heartburn, bloating, passing gas, sour taste, nausea and bad breath. For each of these categories, subjects were to rate during the past seven days, on average, the severity on a 5 point scale ranging from no problem to very severe problem. The scores are combined into a single composite score. The total possible range of the non-pain symptoms subscale is: 7-35.|baseline to 6 Months|Intent to Treat (ITT) Population||Units on SODA Subscale||Standard Error|Least Squares Mean
747140|NCT00527787|Secondary|Mean Change From Baseline on Pain Intensity of the Severity of Dyspepsia Assessment (SODA) Subscales|"Mean Change from Baseline on Pain Intensity of the Severity of Dyspepsia Assessment (SODA) Subscales. There are 6 questions about abdominal pain during the past 7 days: q 1-5 on average: 1. rate with a number between 0 (no pain) and 100 (pain as bad as it could be), 2. rate with a number between 0 (no discomfort) and 10 (discomfort as bad as it can be), 3. on a scale of 5 (from none to excriciating), 4. on 100 mm VAS, 5. on a scale of 4 and 6. worst abdominal pain scale 0 (no discomfort) and 10 (discomfort as bad as it can be). Total composite possible range for pain intensity is: 2-47"|baseline to 6 Months|Intent to Treat (ITT) Population||Units on SODA Subscale||Standard Error|Least Squares Mean
747141|NCT00527787|Secondary|Improvement From Baseline in Upper Abdominal Pain and Discomfort Scores at 6 Months, Based on the Overall Treatment Evaluation for Dyspepsia Questionnaire|"Improvement from baseline in Upper Abdominal Pain and Discomfort scores at 6 months, based on the overall Treatment Evaluation for Dyspepsia Questionnaire. Subjects were asked: since treatment started, has there been any change in your upper abdominal pain and/or discomfort? Answers would be better/about the same/worse. Participants with the response better (instead of about the same or worse), are tabulated by treatment group."|change from baseline at 6 Months|Intent to Treat (ITT) Population||Participants|||Number
747142|NCT00527787|Secondary|Heartburn Symptom Resolution, ie no Heartburn Symptoms During the Last 7 Days Prior to the Visit|"Subjects were asked whether heartburn symptoms within the 7 days prior to the visit were:
none: no symptoms
mild: awareness of symptom, but easily tolerated
moderate: discomforting symptom sufficient to cause interference with normal activities (including sleep)
severe: incapacitating symptom, with inability to perform normal activities (including sleep) Heartburn was defined as a burning feeling rising from the stomach or lower part of the chest towards the neck."|6 months|Intent to Treat (ITT) Population||participants|||Number
747143|NCT00527787|Secondary|The Number of Participants Developing Duodenal Ulcers Throughout 6 Months of Treatment|The Number of Participants Developing Duodenal Ulcers at any time during the 6 Months of the treatment period|6 months|Intent to treat (ITT) population||Participants|||Number
747144|NCT00527787|Secondary|The Number of Participants Discontinuing From the Study Due to NSAID-Associated Upper GI Adverse Events or to Duodenal Ulcer|The Number of Participants Discontinuing from the Study Due to non-steroidal antiinflammatory drug (NSAID)-Associated Upper GI Adverse Events or to Duodenal Ulcer during the treatment period|6 Months|Intention to Treat (ITT) Population||Participants|||Number
747145|NCT00527787|Secondary|The Number of Participants With Pre-Specified NSAID-Associated Upper GI Adverse Events or Duodenal Ulcers|The Number of Participants with Pre-Specified non-steroidal antiinflammatory drug (NSAID)-Associated Upper Gastrointestinal (UGI) Adverse Events or Duodenal Ulcers after 6 months of treatment. Pre-specified UGI adverse events typically associated with NSAID use include dyspepsia, abdominal pain, gastritis, erosive esophagitis, duodenitis, abdominal discomfort|6 months|Intent to Treat (ITT) Population||Participants|||Number
747163|NCT00527878|Secondary|New Lung Infections|Number of new infection while on placebo or study drug|12 months placebo and 12 months ranitidine|Patients who completed the study||new lung infections||Full Range|Median
747148|NCT00527826|Secondary|Mean Change From Baseline in the Total Score of the St. George's Respiratory Questionnaire (SGRQ) at Week 52|Change from baseline was calculated as the total score at Week 52 minus the score at baseline. The SGRQ (a self-administered questionnaire) total score ranges from 0 to 100% and summarizes the impact of COPD on overall health status (summed weights of 15 questions). A total score of 0 indicates the best possible status.|Baseline and Week 52|ITT Population||percent||Standard Deviation|Mean
747149|NCT00527826|Secondary|Mean Change From Baseline in the Impact Score of the St. George's Respiratory Questionnaire (SGRQ) at Week 52|Change from baseline was calculated as the impact score at Week 52 minus the score at baseline. The SGRQ (a self-administered questionnaire) subscale impact score ranges from 0 to 100% and is concerned with social functioning and psychological disturbances (summed weights of 5 questions). A score of 0 indicates the best possible status.|Baseline and Week 52|ITT Population||percent||Standard Deviation|Mean
747150|NCT00527826|Secondary|Mean Change From Baseline in the Activity Score of the St. George's Respiratory Questionnaire (SGRQ) at Week 52|Change from baseline is calculated as the activity score at Week 52 minus the score at baseline. The SGRQ (a self-administered questionnaire) subscale activity score ranges from 0 to 100% and is concerned with activities that cause or are limited by breathlessness (summed weights of 2 questions). A score of 0 indicates the best possible status.|Baseline and Week 52|ITT Population||percent||Standard Deviation|Mean
747151|NCT00527826|Secondary|Mean Change From Baseline in the Symptom Score of the St. George's Respiratory Questionnaire (SGRQ) at Week 52|Change from baseline is calculated as the symptom score at Week 52 minus the symptom score at baseline. The SGRQ (a self-administered questionnaire) subscale symptom score ranges from 0 to 100% and measures the effect of respiratory symptoms, frequency, and severity on quality of life (summed weights of 8 questions). A score of 0 indicates the best possible status.|Baseline and Week 52|ITT Population||percent||Standard Deviation|Mean
747152|NCT00527826|Secondary|Mean Change From Baseline in the Tiffeaneau Index at Week 52|The Tiffeneau index is defined as the FEV1 divided by the IVC (i.e., forced expiratory volume in one second relative to the inspiratory capacity) in percent. Change from baseline is calculated as the FEV1/IVC value at Week 52 minus the value at baseline.|Baseline and Week 52|ITT Population||percent of IVC||Standard Deviation|Mean
747153|NCT00527826|Secondary|Mean Change From Baseline in Inspiratory Vital Capacity (IVC) at Week 52|Change from baseline was measured as the IVC value at Week 52 minus the value at baseline. The post-bronchodilator lung function test was performed to measure IVC 30 minutes after inhaling salbutamol. The most reliable result of three different, consecutive measurements was documented.|Baseline and Week 52|ITT Population||liters||Standard Deviation|Mean
747154|NCT00527826|Secondary|Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 52|Change from baseline was calculated as the FEV1 percent predicted value at Week 52 minus the percent predicted value at baseline. The post-bronchodilator lung function test was performed to measure FEV1 30 minutes after inhaling salbutamol. The most reliable result of three different consecutive measurements was documented.|Baseline and Week 52|ITT Population||percent of predicted value||Standard Deviation|Mean
747155|NCT00527826|Secondary|Mean Number of Days Rescue Medication Was Used|Participants were asked for the number of days they used rescue medication within the 7 days before Week 8 and Week 52.|The 7 days before baseline (=Visit 2 [Week 8]) and the last 7 days of study (=Visit 6 [Week 52])|ITT Population with non-missing data (due to early withdrawal, some data for this outcome measure are missing).||number of days||Standard Deviation|Mean
747156|NCT00527826|Secondary|Number of Participants With the Indicated Number of Hospital Stays|The number of participants with the indicated number of hospitalizations was recorded.|Baseline through Week 52|ITT Population||participants|||Number
747157|NCT00527826|Secondary|Number of Participants With the Indicated Number of Days at the Intensive Care Unit (ICU)|The number participants with the indicated number of days at the ICU was recorded.|Baseline through Week 52|ITT Population of participants who were admitted to the ICU||participants|||Number
747158|NCT00527826|Secondary|Mean Number of COPD-related Visits at/by Physician|The total number of COPD-related visits, i.e., from baseline through week 52, the number of visits at physician's office, the number of home visits made by physician, the number of visits at an emergency outpatient clinic, as well as the number of home visits by an emergency physician were summed up.|Baseline through Week 52|ITT Population with non-missing data (due to early withdrawal some data for this outcome measure are missing)||number of visits||Standard Deviation|Mean
747159|NCT00527826|Primary|Mean Number of Exacerbations Per Year: Poisson Model|During regular visits, participants were asked whether they experienced any exacerbation since last contact. Between visits, COPD participants were contacted by phone by the staff and asked about exacerbation details. Exacerbations were defined according to Rodriguez-Roisin: moderate (grade II) exacerbations include a worsening of COPD symptoms that require both a change of respiratory medication (increased dose of prescribed or addition of new drugs) and medical assistance; severe (grade III) exacerbations include deterioration in COPD resulting in hospitalization or emergency room treatment.|Baseline through Week 52|ITT Population||Number of exacerbations per year||Standard Error|Least Squares Mean
747160|NCT00527826|Secondary|Compliance and Adherence to Study Medication|Compliance is calculated as the ratio (in percent) between the number of actual doses taken during the total treatment period divided by the number of doses that should have been taken during the total treatment period.|Baseline through Week 52|ITT Population||percentage of doses||Standard Deviation|Mean
747161|NCT00527826|Primary|Mean Number of Exacerbations Per Year: Negative Binomial Model|During regular visits, participants were asked whether they experienced any exacerbation since last contact. Between visits, COPD participants were contacted by phone by the staff and asked about exacerbation details. Exacerbations were defined according to Rodriguez-Roisin: moderate (grade II) exacerbations include a worsening of COPD symptoms that require both a change of respiratory medication (increased dose of prescribed or addition of new drugs) and medical assistance; severe (grade III) exacerbations include deterioration in COPD resulting in hospitalization or emergency room treatment.|Baseline through Week 52|Intent-to-Treat (ITT) Population: all participants receiving at least one dose of study medication and suffering from COPD||Number of exacerbations per year||Standard Error|Least Squares Mean
747162|NCT00527878|Secondary|Clinical Severity Score|Scoring that was completed every 3 months. Clinical severity scored had outcomes that could range from 0 to 121 with 0 being the least severe and 121 being the most severe.|one year on ranitidine and one year on placebo|Patients who completed the study||score on a scale||Full Range|Mean
747165|NCT00527878|Primary|Number of Infections in Subjects With HIES.|Patients received one year of treatment medication and one year of placebo. New infections (bacterial, fungal, viral or parasitic) were defined as those requiring an addition or change of an antimicrobial (including topical, oral or intravenous therapies) or those requiring a medical procedure (i.e., incision and drainage of a skin abscess, warm soaks to aid abscess drainage or sinus drainage).|1 year on intervention|Patients that completed both arms of the study (24 months)||infections||Full Range|Median
747166|NCT00527904|Primary|Number of Subjects Monitored for Long-term Safety of PN 400|Incidence of adverse events and monitoring vital signs, clinical laboratory values, physical exams, ECG. All AEs were coded into preferred terms according to MedDRA (Medical Dictionary for Regulatory Activities) and classified by system organ class (SOC). Summaries of the incidence of all treatment-emergent AEs, treatment-related AEs, SAEs, and AEs leading to study drug discontinuation were prepared. Treatment-emergent AEs were also summarized by maximum severity, by quartile of number of doses taken and by treatment window.|12 months|Approximately 200 subjects were planned, 239 were enrolled and treated and 143 subjects completed the study. All 239 subjects were evaluable for safety.||participants|||Number
747167|NCT00527943|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced a Stroke Within 2 Years From Randomization|The time (in days) from study start to first experience of a stroke was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced a stroke within 2 years from randomization.|Up to 2 years|Intent to Treat Population, defined as all participants who were randomly assigned to a treatment arm.||Percentage of Participants|||Number
747168|NCT00527943|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Died From Any Cause Within 2 Years From Randomization|The time (in days) from study start to death from any cause was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who died from any cause within 2 years from randomization.|Up to 2 years|Intent to Treat Population, defined as all participants who were randomly assigned to a treatment arm.||Percentage of Participants|||Number
747169|NCT00527943|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced UCR Within 2 Years From Randomization|The time (in days) from study start to the first occurrence of UCR was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced UCR within 2 years from randomization.|Up to 2 years|Intent to Treat Population, defined as all participants who were randomly assigned to a treatment arm.||Percentage of Participants|||Number
747170|NCT00527943|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced RIR Within 2 Years From Randomization|The time (in days) from study start to the first occurrence of RIR was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced RIR within 2 years from randomization.|Up to 2 years|Intent to Treat Population, defined as all participants who were randomly assigned to a treatment arm||Percentage of Participants|||Number
747171|NCT00527943|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced an MI Within 2 Years From Randomization|The time (in days) from study start to the first occurrence of an MI was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced an MI within 2 years from randomization.|Up to 2 years|Intent to Treat Population, defined as all participants who were randomly assigned to a treatment arm.||Percentage of Participants|||Number
747172|NCT00527943|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death Within 2 Years From Randomization|The time (in days) from study start to the CV death (if reported) was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death within 2 years from randomization.|Up to 2 years|Intent to Treat Population, defined as all participants who were randomly assigned to a treatment arm.||Percentage of Participants|||Number
747173|NCT00527943|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced All-cause Death, MI, Stroke, or UCR Within 2 Years From Randomization|The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: all-cause death, MI, stroke, or UCR. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who experienced all-cause Death, MI, stroke, or UCR I within 2 years from randomization.|Up to 2 years|Intent to Treat Population, defined as all participants who were randomly assigned to a treatment arm.||Percentage of Participants|||Number
747174|NCT00527943|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced All-cause Death, MI, Stroke, RIR, or UCR Within 2 Years From Randomization|The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: all-cause death, MI, stroke, RIR, or UCR. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who experienced all-cause death, MI, stroke, RIR, or UCR within 2 years from randomization.|Up to 2 years|Intent to Treat population, defined as all participants who were randomly assigned to a treatment arm.||Percentage of Participants|||Number
747175|NCT00527943|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death or MI Within 2 Years From Randomization|The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: CV death or MI. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death or MI within 2 years from randomization.|Up to 2 years|Intent to Treat Population, defined as all participants who were randomly assigned to a treatment arm.||Percentage of Participants|||Number
747176|NCT00527943|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death, MI, Stroke, or UCR Within 2 Years From Randomization|The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: CV death, MI, stroke, or UCR. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death, MI, stroke, or UCR within 2 years from randomization.|Up to 2 years|Intent to Treat Population, defined as all participants who were randomly assigned to a treatment arm.||Percentage of Participants|||Number
747177|NCT00527943|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Clinically Significant Bleeding Within 2 Years From Randomization|Adverse events were categorized as “bleeding events” if the intensity of the event was other or more than would be normally expected in the given situation (eg, mild nosebleed in a person who does not normally have nosebleeds, greater bruising than expected for a given injury, greater volume of blood loss than expected for a given procedure). The investigator graded the intensity of bleeding events according to the Thrombolysis in Myocardial Infarction (TIMI) Study Group criteria as major, minor or other. “Clinically Significant Bleeding” was defined as the composite of TIMI Major bleeding, TIMI Minor bleeding, or bleeding that required unplanned medical or surgical treatment or unplanned laboratory evaluation even if it did not meet the criteria for TIMI major or minor bleeding. The Kaplan-Meier estimate reports the percentage of participants who experienced clinically significant bleeding within 2 years from randomization.|Up to 2 years|As Treated Population, which included all participants who received at least 1 dose of study medication.||Percentage of Participants|||Number
747178|NCT00527943|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Met Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) Moderate or Severe Bleeding Criteria Within 2 Years From Randomization|Adverse events were categorized as “bleeding events” if the intensity of the event was other or more than would be normally expected in the given situation (eg, mild nosebleed in a person who does not normally have nosebleeds, greater bruising than expected for a given injury, greater volume of blood loss than expected for a given procedure). The investigator graded the intensity of bleeding events according to the GUSTO cooperative group criteria as follows: Mild , Moderate or Severe and the grading was adjudicated by the CEC. The Kaplan-Meier estimate reports the percentage of participants who experienced GUSTO moderate or severe bleeding within 2 years from randomization.|Up to 2 years|As Treated Population, which included all participants who received at least 1 dose of study medication.||Percentage of Participants|||Number
747179|NCT00527943|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Cardiovascular Death, Myocardial Infarction, and/or Stroke Within 2 Years From Randomization|The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: cardiovascular (CV) death, myocardial infarction (MI), and/or stroke. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced at least 1 of the components of the secondary composite efficacy endpoint within 2 years from randomization.|up to 2 years|Intent to Treat Population, defined as all participants who were randomly assigned to a treatment arm.||Percentage of Participants|||Number
747180|NCT00527943|Primary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Cardiovascular Death, Myocardial Infarction, Stroke, Recurrent Ischemia With Re-hospitalization, and/or Urgent Coronary Revascularization Within 2 Years From Randomization|The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: cardiovascular (CV) death, myocardial infarction (MI), stroke, recurrent ischemia with re-hospitalization (RIR), and/or urgent coronary revascularization (UCR). A Clinical Endpoints Committee (CEC) reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced at least 1 of the components of the primary composite efficacy endpoint within 2 years from randomization.|Up to 2 years|Intent to Treat Population, defined as all participants who were randomly assigned to a treatment arm.||Percentage of Participants|||Number
747184|NCT00521053|Post-Hoc|Rate of Complete Response|Using modified Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for cutaneous or subcutaneous target lesions assessed by ruler, caliper or ultrasound: Complete Response (CR), disappearance of all target lesions; Complete Response Rate (CRR) = %CR.|52 weeks|ITT participants having all baseline disease injected with PV-10||percentage of participants||95% Confidence Interval|Number
747185|NCT00521053|Secondary|Progression Free Survival (PFS)|Progression is defined using modified Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or significant worsening of non-target disease (e.g., a measurable increase in non-target lesions or the appearance of new lesions) indicative of disease progression.|52 weeks|||Months||95% Confidence Interval|Median
747186|NCT00521053|Secondary|Objective Response Rate of Untreated Bystander Lesions|Using modified Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for designated, untreated cutaneous or subcutaneous bystander lesions assessed by ruler, caliper or ultrasound: Complete Response (CR), disappearance of all bystander lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of bystander lesions; Objective Response Rate (ORR) = %CR + %PR.|52 weeks|ITT participants having at least one uninjected dermal bystander lesion designated at baseline (some ITT participants did not have at least one bystander lesion).||percentage of participants||95% Confidence Interval|Number
747187|NCT00521053|Primary|Objective Response Rate (ORR) of PV-10 Treated Lesions|Using modified Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for cutaneous or subcutaneous target lesions assessed by ruler, caliper or ultrasound: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response Rate (ORR) = %CR + %PR.|52 weeks|ITT participants||percentage of participants||95% Confidence Interval|Number
747188|NCT00521079|Secondary|Percentage of Participants Achieving 25% Excess Weight Loss (%EWL)|To evaluate the percentage of participants achieving 25% excess weight loss from baseline (implant) to 12 months between treatment groups.|Baseline and 1 Year|||Percentage of subjects|||Number
747189|NCT00521079|Primary|Rate of System and Procedure-related Serious Adverse Events (SAEs).|To estimate the rate of serious, system- and procedure-related adverse events associated with the Maestro System.|1 Year|||Events|||Number
747190|NCT00521079|Primary|Percentage of Excess Weight Loss (EWL) With the Maestro System|Observe at least a 10% greater percentage excess weight loss (%EWL) with vBloc therapy delivered by the Maestro System compared to sham 12 months following randomization using MetLife Method (ideal body weight is calculated based on Metropolitan Height and Weight Tables)|Baseline and 1 Year|||Percentage of excess weight loss||Standard Error|Mean
747191|NCT00521144|Primary|Overall Response Rate (Phase II)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR)=CR +PR|Every 6 weeks, assessed up to 30 days|Only those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response.||participants|||Number
747192|NCT00528112|Secondary|Number of Participants With Partial or Total Expulsion up to 5 Years|If LCS was displaced, but still in the cervical canal, it was assessed as being partially displaced. If LCS was expelled from the uterus, it was assessed as a total expulsion.|Up to 5 years|All participants from the full analysis set who had an assessment for this evaluation||Participants|||Number
747193|NCT00528112|Secondary|Degree of User Overall Satisfaction With Study Treatment up to 5 Years|Overall user satisfaction was assessed by a questionnaire given to participants at the end of the study. The questionnaire was only given to participants whose end-of-study visit occurred after implementation of Protocol Amendment 3.|At the end of study/Year 5|All participants from the full analysis set who participated in the extension phase and had an assessment for this evaluation||Participants|||Number
747194|NCT00528112|Secondary|Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 20|The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.|Day 1711 to Day 1800|All participants from the full analysis set who had an assessment for this evaluation||Days||Standard Deviation|Mean
747195|NCT00528112|Secondary|Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 13|The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.|Day 1081 to Day 1170|All participants from the full analysis set who had an assessment for this evaluation||Days||Standard Deviation|Mean
747196|NCT00528112|Primary|Pearl Index for LCS16 up to 5 Years|The unadjusted Pearl Index (PI) is defined as the number of pregnancies per 100 woman years.|Up to 5 years|Full analysis set||Pregnancies per 100 women years||95% Confidence Interval|Number
747197|NCT00528112|Secondary|Number of Participants With Partial or Total Expulsion|If LCS was displaced, but still in the cervical canal, it was assessed as being partially displaced. If LCS was expelled from the uterus, it was assessed as a total expulsion.|Up to 3 years|All participants from the full analysis set who had an assessment for this evaluation||Participants|||Number
747198|NCT00528112|Secondary|Degree of User Overall Satisfaction With Study Treatment|Overall user satisfaction was assessed by a questionnaire given to participants at the end of the study. The questionnaire was only given to participants whose end-of-study visit occurred after implementation of Protocol Amendment 3.|At the end of study/Year 3|All participants from the full analysis set who had an assessment for this evaluation||Participants|||Number
747199|NCT00528112|Secondary|Classification of Endometrium – Year 3 / End of Study|The histological evaluation of the endometrium examined the effects of progesterone on the endometrium|At Year 3 / End of study|A subset of women from the full analysis set||Participants|||Number
747200|NCT00528112|Secondary|Classification of Endometrium – Year 2|The histological evaluation of the endometrium examined the effects of progesterone on the endometrium|At Year 2|A subset of women from the full analysis set||Participants|||Number
747201|NCT00528112|Secondary|Classification of Endometrium – Year 1|The histological evaluation of the endometrium examined the effects of progesterone on the endometrium|At Year 1|A subset of women from the full analysis set||Participants|||Number
747203|NCT00528112|Secondary|Average Total Cervical Score – Year 2|"Cervical mucus samples were analyzed to determine any effects of progesterone on the cervical mucus.
Range of score: 0 (high contraceptive efficacy) to 12 (low contraceptive efficacy)"|For six weeks in the second half of Year 2|A subset of women from the full analysis set||Scores on a scale||Standard Deviation|Mean
747204|NCT00528112|Secondary|Average Total Cervical Score – Year 1|Cervical mucus samples were analyzed to determine any effects of progesterone on the cervical mucus. Range of score: 0 (high contraceptive efficacy) to 12 (low contraceptive efficacy)|For six weeks in the second half of Year 1|A subset of women from the full analysis set||Scores on a scale||Standard Deviation|Mean
747205|NCT00528112|Secondary|Number of Participants With/Without Ovulation – Year 3|Serum concentrations of progesterone were analyzed. All subjects with progesterone values equal to or greater than 2.5 ng/ml were assessed as having an ovulation.|For six weeks in the second half of Year 3|A subset of women from the full analysis set||Participants|||Number
747206|NCT00528112|Secondary|Number of Participants With/Without Ovulation – Year 2|Serum concentrations of progesterone were analyzed. All subjects with progesterone values equal to or greater than 2.5 ng/ml were assessed as having an ovulation.|For six weeks in the second half of Year 2|A subset of women from the full analysis set||Participants|||Number
747207|NCT00528112|Secondary|Number of Participants With/Without Ovulation – Year 1|Serum concentrations of progesterone were analyzed. All subjects with progesterone values equal to or greater than 2.5 ng/ml were assessed as having an ovulation.|For six weeks in the second half of Year 1|A subset of women from the full analysis set||Participants|||Number
747208|NCT00528112|Secondary|Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 12|The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.|Day 331 to Day 360|All participants from the full analysis set who had an assessment for this evaluation||Days||Standard Deviation|Mean
747209|NCT00528112|Secondary|Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 4|The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.|Day 91 to Day 120|All participants from the full analysis set who had an assessment for this evaluation||Days||Standard Deviation|Mean
747210|NCT00528112|Secondary|Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 3|The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.|Day 61 to Day 90|All participants from the full analysis set who had an assessment for this evaluation||Days||Standard Deviation|Mean
747211|NCT00528112|Secondary|Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 2|The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.|Day 31 to Day 60|All participants from the full analysis set who had an assessment for this evaluation||Days||Standard Deviation|Mean
747212|NCT00528112|Secondary|Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 1|The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.|Day 1 to Day 30|All participants from the full analysis set who had an assessment for this evaluation||Days||Standard Deviation|Mean
747213|NCT00528112|Secondary|Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 12|The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.|Day 991 to Day 1080|All participants from the full analysis set who had an assessment for this evaluation||Days||Standard Deviation|Mean
747214|NCT00528112|Secondary|Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 4|The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.|Day 271 to Day 360|All participants from the full analysis set who had an assessment for this evaluation||Days||Standard Deviation|Mean
747215|NCT00528112|Secondary|Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 3|The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.|Day 181 to Day 270|All participants from the full analysis set who had an assessment for this evaluation||Days||Standard Deviation|Mean
747216|NCT00528112|Secondary|Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 2|The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.|Day 91 to Day 180|All participants from the full analysis set who had an assessment for this evaluation||Days||Standard Deviation|Mean
747217|NCT00528112|Secondary|Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 1|The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.|Day 1 to Day 90|All participants from the full analysis set who had an assessment for this evaluation||Days||Standard Deviation|Mean
747218|NCT00528112|Primary|Pearl Index up to 3 Years|The unadjusted Pearl Index (PI) is defined as the number of pregnancies per 100 woman years. The 3-year PI was obtained by dividing the number of pregnancies that occurred during the first three years of treatment by the time (in 100 women years) that the women were at risk of getting pregnant.|Up to 3 years|Full analysis set||Pregnancies per 100 women years||95% Confidence Interval|Number
747592|NCT00530842|Secondary|Static Lung Volumes|Post-dose TLC (Total Lung Capacity) after 4 weeks (measured by bodyphlethysmography)|4 weeks|FAS using imputed values||Litres||Standard Error|Mean
747219|NCT00528190|Primary|The Primary Outcome Measure Will be the Number of Patients Who Experience a Respiratory Exacerbation Requiring Intravenous Antibiotics in the Two Treatment Groups Over the 24 Week Trial Treatment Period.|The Primary outcome measure will be the number of patients who experience a respiratory exacerbation requiring intravenous antibiotics in the two treatment groups over the 24 week trial treatment period.|24 weeks|||Participants|||Count of Participants
747220|NCT00528268|Secondary|The Study Will Determine Potential Benefit of NaPB on Lean Body Mass; Overall Motor Function; Potential Cellular Response to NaPB; and Drug Compliance.||24 months||||||
747221|NCT00528268|Primary|The Study Will Assess the Safety, Tolerability and Potential Efficacy of Sodium Phenylbutyrate (NaPB) in Presymptomatic Infants Genetically Confirmed to Have SMA. It Will Also Determine Selected Pharmacokinetic Parameters.|Number of participants with SAE's related to research.|24 months|||participants|||Number
747222|NCT00528931|Secondary|Change From Baseline Range of Motion|Range of motion defined as the difference between the finger extension angle and finger flexion angle expressed in degrees|Baseline, 30 days after treatment to the primary joint|Efficacy assessment based on safety population which included all enrolled subjects who received the AA4500 injection.||Degrees|Joints|Standard Deviation|Mean
747223|NCT00528931|Secondary|Percent Change From Baseline Contracture|Change from baseline in the degree of fixed-flexion contracture calculated as 100 times (baseline contracture minus last available post-injection contracture measurement) divided by baseline contracture where a positive change indicates a reduction in the degree of contracture.|Baseline, 30 days after treatment to the primary joint|Efficacy assessment based on safety population which included all enrolled subjects who received the AA4500 injection.||Percentage of contracture change|Joints|Standard Deviation|Mean
747224|NCT00528931|Secondary|Clinical Improvement|Clinical improvement defined as ≥50% reduction from baseline in contracture within 30 days of the injection. LOCF after the injection was used if the status at day 30 could not be determined.|30 days after treatment to the primary joint|Efficacy assessment based on safety population which included all enrolled subjects who received the AA4500 injection.||Percentage of joints|Joints||Number
747225|NCT00528931|Secondary|Clinical Success|Clinical success defined as a reduction in contracture (ie, flexion deformity) to ≤5° of normal as measured by finger goniometry 30 days after an injection. Last observation carried forward (LOCF) after the injection was used if the status at day 30 could not be determined.|30 days after treatment to the primary joint|Efficacy assessment based on safety population which included all enrolled subjects who received the AA4500 injection||Percentage of joints|Joints||Number
747226|NCT00528931|Primary|Number of Subjects With AUX I and AUX II Detected in Their Blood After a Single Dose of AA4500|AUX I and AUX II are the constituent protein collagenases of collagenase clostridium histolyticum (AA4500). Plasma concentrations of AUX I and AUX II were assessed through an enzymye-linked-immunoabsorbent assay (ELISA).|Before dosing, at predetermined time points through the 24 hours after dosing, Day 7, and Day 30|Pharmacokinetic population||participants|||Number
747227|NCT00528957|Secondary|Change From Baseline in CD4 Cell Count (Cells/mm^3) at 336 Weeks||Baseline and 336 weeks||||||
747228|NCT00528957|Secondary|Change From Baseline in CD4 Cell Count (Cells/mm^3) at 288 Weeks||Baseline and 288 weeks||||||
747229|NCT00528957|Secondary|Change From Baseline in CD4 Cell Count (Cells/mm^3) at 240 Weeks||Baseline and 240 weeks||||||
747230|NCT00528957|Secondary|Change From Baseline in CD4 Cell Count (Cells/mm^3) at 192 Weeks||Baseline and 192 weeks||||||
747231|NCT00528957|Secondary|Change From Baseline in CD4 Cell Count (Cells/mm^3) at 144 Weeks|This is the change from baseline in CD4 cell count after 144 weeks of exposure to TDF.|Baseline and 144 weeks|Intent-to-treat, Missing = Excluded||cells/mm^3||Standard Deviation|Mean
747232|NCT00528957|Secondary|Change From Baseline in CD4 Cell Count (Cells/mm^3) at 96 Weeks|This is the change from baseline in CD4 cell count after 96 weeks of exposure to TDF.|Baseline and 96 weeks|Intent-to-treat, Missing = Excluded||cells/mm^3||Standard Deviation|Mean
747233|NCT00528957|Secondary|Change From Baseline in CD4 Cell Count (Cells/mm^3) at 48 Weeks|This is the change from baseline in CD4 cell count after 48 weeks of exposure to randomized study drug.|Baseline and 48 weeks|Intent-to-treat, Missing = Excluded||cells/mm^3||Standard Deviation|Mean
747234|NCT00528957|Secondary|Change From Baseline in CD4 Percentage at 336 Weeks||Baseline and 336 weeks||||||
747235|NCT00528957|Secondary|Change From Baseline in CD4 Percentage at 288 Weeks||Baseline and 288 weeks||||||
747236|NCT00528957|Secondary|Change From Baseline in CD4 Percentage at 240 Weeks||Baseline and 240 weeks||||||
747237|NCT00528957|Secondary|Change From Baseline in CD4 Percentage at 192 Weeks||Baseline and 192 weeks||||||
747238|NCT00528957|Secondary|Change From Baseline in CD4 Percentage at 144 Weeks|This is the change from baseline in CD4 percentage after 144 weeks of exposure to TDF.|Baseline and 144 weeks|Intent-to-treat, Missing = Excluded||CD4 Percentage||Standard Deviation|Mean
747239|NCT00528957|Secondary|Change From Baseline in CD4 Percentage at 96 Weeks|This is the change from baseline in CD4 percentage after 96 weeks of exposure to TDF.|Baseline and 96 weeks|Intent-to-treat, Missing = Excluded||CD4 Percentage||Standard Deviation|Mean
747240|NCT00528957|Secondary|Change From Baseline in CD4 Percentage at 48 Weeks|This is the change from baseline in CD4 percentage after 48 weeks of exposure to randomized study drug.|Baseline and 48 weeks|Intent-to-treat, Missing = Excluded||CD4 Percentage||Standard Deviation|Mean
747241|NCT00528957|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 336 Weeks||336 weeks||||||
747242|NCT00528957|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 288 Weeks||288 weeks||||||
747243|NCT00528957|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 240 Weeks||240 weeks||||||
747244|NCT00528957|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 192 Weeks||192 weeks||||||
747245|NCT00528957|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 144 Weeks|This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 144 weeks of exposure to TDF.|144 weeks|Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.||percentage of participants|||Number
747417|NCT00529763|Secondary|Mean Oral Clearance (CLo) of Dasatinib Following 70 mg BID and 100 QD Dose Administration||Day 1 (0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours postdose), Day 8 (0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12 hours postdose)|Number of treated participants with measurement at time point||mL/h||Standard Deviation|Mean
747246|NCT00528957|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 96 Weeks|This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 96 weeks of exposure to TDF.|96 weeks|Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.||percentage of participants|||Number
747247|NCT00528957|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 48 Weeks|This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 48 weeks of exposure to randomized study drug.|48 weeks|Intent-to-treat, Missing = Failure||percentage of participants|||Number
747248|NCT00528957|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 336 Weeks||336 weeks||||||
747249|NCT00528957|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 288 Weeks||288 weeks||||||
747250|NCT00528957|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 240 Weeks||240 weeks||||||
747251|NCT00528957|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 192 Weeks||192 weeks||||||
747252|NCT00528957|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 144|This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 144 weeks of exposure to TDF.|144 weeks|Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.||percentage of participants|||Number
747253|NCT00528957|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96|This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 96 weeks of exposure to TDF.|96 weeks|Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.||percentage of participants|||Number
747254|NCT00528957|Secondary|Virologic Success at 48 Weeks (HIV-1 RNA Cutoff at 400 Copies/mL, Snapshot)|This is the percentage of participants with virologic success after 48 weeks of exposure to randomized study drug.|48 weeks|ITT Analysis Set; only includes participants < 12 years of age at baseline||percentage of participants|||Number
747255|NCT00528957|Primary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48|This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 48 weeks of exposure to randomized study drug.|48 weeks|Intent-to-treat, Missing = Failure||percentage of participants|||Number
747256|NCT00529035|Secondary|Treg Cell:Tcon Cell Ratio|"Changes in the ratio of the CD4+ regulatory T cell (Treg) and CD4+ conventional T cell (Tcon) counts were measured at study appointments during the 8-week IL-2 treatment and four weeks post study therapy.
All study participants (n=28) with a sample available were reported in the data table.
Immune outcome data cannot be meaningfully rendered in the template provided, owing to complexity. The tables below only represent a general overview of the data. Please refer to figure 2 in our published report (Koreth et al, NEJM 2011)."|Immunological samples taken at study appointments during the 12 week protocol schedule|Participants were evaluated for changes to the ratio of regulatory T cell (Treg) and conventional T cell (Tcon) counts while on IL-2 therapy. Participants had blood samples drawn at study appointments during the 12 week protocol schedule to analyze the immunological effects of low-dose IL-2 therapy.||ratio||Inter-Quartile Range|Median
747257|NCT00529035|Secondary|CD3+T, CD4+T (Including Regulatory CD4+T Cells (Treg) and Conventional CD4+T Cells (Tcon)), CD8+T, NK, NKT and B Cell Counts.|"Changes in the above immune cell populations (CD3+T, CD4+T (including CD4+Treg and CD4+Tcon), CD8+T, NK, NKT and B cell counts were measured at study appointments during the 8-week IL-2 treatment and four weeks post study therapy.
All study participants (n=28) with a sample available were reported in the data table.
Immune outcome data cannot be meaningfully rendered in the template provided, owing to complexity. The tables below only represent a general overview of the data. Please refer to figure 2 in our published report (Koreth et al, NEJM 2011)."|Immunological samples taken at study appointments during the 12 week protocol schedule|Participants were evaluated for regulatory T cell (Treg) expansion and other immune-cell changes while on low-dose IL-2 therapy. Participants had blood samples drawn at study appointments during the 12 week protocol schedule. Please note that for NK and NKT cell counts, only 18 participants samples were analyzed.||cells/cubic millimeter||Inter-Quartile Range|Median
747258|NCT00529035|Secondary|The Number of Participants Who Tolerated at Least 6 Weeks of Subcutaneous Low Dose IL-2.|"Feasibility: the number of participants who tolerated at least 6 weeks of therapy, and were thus evaluable for response. Efficacy: chronic GVHD response per NIH consensus criteria in evaluable patients.
A complete response was defined as resolution of all reversible chronic GVHD–associated manifestations, a partial response as an improvement of 50% or more on the organ-specific chronic GVHD scale without progression at other organs or sites, progressive disease as an increase of 25% or more on the organ specific chronic GVHD scale, and stable disease as an improvement of less than 50% or increase of less than 25%. Please refer to the Supplementary Appendix in our published report (Koreth et al, NEJM 2011) for further details."|Participants were assessed for toxicities at mandatory study follow-up visits during the 8 week course of study therapy and four weeks post therapy. cGVHD was assessed at Weeks 8 and 12|Participants were evaluable for response and considered meeting the feasibility endpoint if they completed at least 6 weeks of treatment. Participants who had a partial response or complete response in cGVHD to treatment were considered to meet the efficacy endpoint.||participants|||Number
747259|NCT00529035|Primary|The Maximum Tolerated Dose and Toxicity Profile of an 8 Week Course of IL-2 in Patients With cGVHD and an Inadequate Response to Steroids.|"Three dose levels were evaluated to determine the maximally tolerated dose (MTD):
Dose level A: 0.3 x 10^6 IU/m^2/day Dose level B: 1.0 x 10^6 IU/m^2/day Dose level C: 3.0 x 10^6 IU/m^2/day Once the MTD (dose level B) was established, an additional 10 participants were enrolled at this dose."|Participants were assessed for toxicities at mandatory study follow-up visits during the 8 week course of study therapy and four weeks post therapy|One participant terminated therapy early and was not evaluable for this outcome measure.||million IU/m2/day|||Number
747260|NCT00529087|Secondary|Change in Percentage of Rescue-free Bowel Movements (RFBM) With a Sensation of Complete Evacuation From Baseline During Double-blind Period|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS). A complete RFBM has a sensation of complete evacuation.|4 weeks|Patients who were randomized and received at least 1 dose of double-blinded test article. Last observation carried forward (LOCF)||percentage change||Standard Error|Mean
747261|NCT00529087|Secondary|Change in Percentage of Rescue-free Bowel Movements (RFBM) With Straining Scale Scores of 0 or 1 (no, or Mild) From Baseline During Double-blind Period|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS). The amount of straining associated with bowel movements was assessed using a 5-point straining scale, where 0=none, 1 = mild and 4=very severe.|4 weeks|Patients who were randomized and received at least 1 dose of double-blinded test article. Last observation carried forward (LOCF)||percentage change||Standard Error|Mean
747262|NCT00529087|Secondary|Percentage of Patients With Any Diarrhea or Watery Rescue-free Bowel Movements (RFBM) During Open-label Period.|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS). The Bristol Stool Form Scale assessed stool quality using a 7-point scale, where Type 1 = separate hard lumps like nuts (difficult to pass), Type 6 = fluffy pieces with ragged edges, a mushy stool, and Type 7 = watery, no solid pieces (entirely liquid.) This analysis included types 6 and 7.|weeks 5-12|Patients who continued into the open-label period and received at least 1 dose of test article.||percentage of participants|||Number
747263|NCT00529087|Secondary|Change in Percentage of Rescue-free Bowel Movements (RFBM) Classified as Diarrhea or Watery Stools From Baseline During Double-blind Period|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS). The Bristol Stool Form Scale assessed stool quality using a 7-point scale, where Type 1 = separate hard lumps like nuts (difficult to pass), Type 6 = fluffy pieces with ragged edges, a mushy stool, and Type 7 = watery, no solid pieces (entirely liquid.) This analysis included types 6 and 7.|4 weeks|Patients who were randomized and received at least 1 dose of double-blinded test article. Last observation carried forward (LOCF)||percentage change||Standard Error|Mean
747264|NCT00529087|Secondary|Change in Percentage of Rescue-free Bowel Movements (RFBM) With Bristol Stool Form Scale in Type 3 or Type 4 From Baseline During Double-blind Period|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone IVRS. The Bristol Stool Form Scale assessed stool quality using a 7-point scale, where Type 1=separate hard lumps like nuts (difficult to pass) and Type 7=watery, no solid pieces (entirely liquid.) Specifically, Type 3=like a sausage but with cracks on the surface, Type 4=Like a sausage or snake, smooth and soft.|4 weeks|Patients who were randomized and received at least 1 dose of double-blinded test article. Last observation carried forward (LOCF)||percentage change||Standard Error|Mean
747265|NCT00529087|Secondary|Percentage of Patients With Improvement in Straining Scale Score for Rescue-free Bowel Movements (RFBM) by 1 Point During Open Label Period|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS). The amount of straining associated with bowel movements was assessed using a 5-point straining scale, where 0=none and 4=very severe.|8 weeks|Patients who continued into the open-label period and received at least 1 dose of test article.||percentage of participants|||Number
747266|NCT00529087|Secondary|Percentage of Patients With Improvement in Bristol Stool Form Scale Score for Rescue-free Bowel Movements (RFBM) by 1 Point During Open Label Period|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS). The Bristol Stool Form Scale assessed stool quality using a 7-point scale, where Type 1 = separate hard lumps like nuts (difficult to pass) and Type 7 = watery, no solid pieces (entirely liquid.)|8 weeks|Patients who continued into the open-label period and received at least 1 dose of test article.||percentage of participants|||Number
747267|NCT00529087|Secondary|Change in Straining Scale Score of Rescue-free Bowel Movements (RFBM) From Baseline During Double-blind Period|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS). The amount of straining associated with bowel movements was assessed using a 5-point straining scale, where 0=none and 4=very severe.|4 weeks|Patients who were randomized and received at least 1 dose of double-blinded test article. Last observation carried forward (LOCF)||units on scale||Standard Error|Mean
747268|NCT00529087|Secondary|Change in Bristol Stool Form Scale Score for Rescue-free Bowel Movements (RFBM)|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS). The Bristol Stool Form Scale assessed stool quality using a 7-point scale, where Type 1 = separate hard lumps like nuts (difficult to pass) and Type 7 = watery, no solid pieces (entirely liquid.)|4 weeks|Patients who were randomized and received at least 1 dose of double-blinded test article. Last observation carried forward (LOCF)||units on scale||Standard Error|Mean
747269|NCT00529087|Secondary|Change in Weekly Number of Complete Rescue-free Bowel Movements (RFBM)|A rescue-free bowel movement defined as a bowel movement with no laxatives use during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were reported daily by patient using a telephone interactive voice response system (IVRS). Weekly number of complete RFBM was the total number of complete RFBM reported in study period divided by the number of days with information, and multiplied by 7 for a normalized weekly number. A complete RFBM has a sensation of complete evacuation.|4 weeks|Patients who were randomized and received at least 1 dose of double-blinded test article. Last observation carried forward (LOCF)||bowel movements||Standard Error|Mean
747593|NCT00530842|Secondary|Static Lung Volumes|Post-dose TLC (Total Lung Capacity) after 8 weeks (measured by bodyphlethysmography)|8 weeks|FAS using imputed values||Litres||Standard Error|Mean
747270|NCT00529087|Secondary|Change From Baseline in Weekly Number of Quality Rescue-free Bowel Movements (RFBM)|RFBM defined as bowel movement with no laxatives during the prior 24 hours. Information on laxative use, bowel movements and assessments were reported daily by patient. Weekly number of quality RFBM was the total number of quality RFBM reported in study period divided by number of days with information and multiplied by 7 for a normalized weekly number. Stool quality assessed with the Bristol Stool Form Scale (7-points) (1=difficult to pass, 7=entirely liquid). A quality RFBM defined as one other than diarrhea (Bristol Type 1–5).|4 weeks|Patients who were randomized and received at least 1 dose of double-blinded test article. Last observation carried forward (LOCF)||bowel movements||Standard Error|Mean
747271|NCT00529087|Secondary|Change in Weekly Number of Bowel Movements During Double-blind Period|Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS). The weekly number of BM was defined as the total number of BMs reported during study period divided by the number of days the subject reported diary information in that period, and then multiplied by 7 to normalize to a weekly number.|4 weeks|Patients who were randomized and received at least 1 dose of double-blinded test article. Last observation carried forward (LOCF)||bowel movements||Standard Error|Mean
747272|NCT00529087|Secondary|Percentage of Patients With an Increase of at Least 1 in the Weekly Rescue-free Bowel Movement (RFBM) Rate From Baseline for the Double-blind Period at 4 Weeks|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone IVRS. The weekly RFBM rate was defined as the total number of RFBM reported during study period divided by the number of days the subject reported diary information in that period, and then multiplied by 7 to normalize to a weekly rate.|Baseline and 4 weeks|Patients who were randomized and received at least 1 dose of double-blinded test article. Last observation carried forward (LOCF)||percentage of participants|||Number
747273|NCT00529087|Secondary|Percentage of Patients With a Weekly Rescue-free Bowel Movement (RFBM) Rate ≥ 3 and an Increase of at Least 1 in the Weekly RFBM Rate From Baseline for the Double-blind Period|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone IVRS. The weekly RFBM rate was defined as the total number of RFBM reported during study period divided by the number of days the subject reported diary information in that period, and then multiplied by 7 to normalize to a weekly rate.|4 weeks|Patients who were randomized and received at least 1 dose of double-blinded test article. Last observation carried forward (LOCF)||percentage of participants|||Number
747274|NCT00529087|Secondary|Percentage of Injections Resulting in Any Rescue-free Bowel Movement (RFBM) Within 1, 2, 3, 4 and 6 Hours in Double-blind Period|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS).|Within 1-6 hours during 4-week double-blind period|Patients who were randomized and received at least 1 dose of double-blinded test article. Last observation carried forward (LOCF).||percentage of injections||Standard Deviation|Mean
747275|NCT00529087|Secondary|Percentage of Active Injections Resulting in Any Rescue-free Bowel Movement (RFBM) Within 1, 2, 3 and 6 Hour(s) in Double-blind Period|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS). Active injections are those that contain study drug (e.g., daily injections in MOA-728 QD treatment group and every other injection for the MOA-728 QOD treatment group). The corresponding injections in the placebo group were used as controls.|Within 1-6 hours during 4 week double-blind period|Patients who were randomized and received at least 1 dose of double-blinded test article. Last observation carried forward (LOCF).||percentage of active injections||Standard Deviation|Mean
747276|NCT00529087|Secondary|Percentage of Patients Achieving at Least 3 Rescue-free Bowel Movements (RFBM) Per Week in Double-blind Period|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone IVRS. The weekly number of RFBM was defined as the total number of RFBM reported during the study week divided by the number of days the patient reported diary information in that period, and then multiplied by 7 to normalize to a weekly number.|4 weeks|Patients who were randomized and received at least 1 dose of double-blinded test article.||percentage of participants|||Number
747277|NCT00529087|Secondary|Weekly Number of Rescue-free Bowel Movements (RFBM) (Open-label Period)|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone IVRS. The weekly number of RFBM was defined as the total number of RFBMs reported during study period divided by the number of days the patient reported diary information in that period, and then multiplied by 7 to normalize to a weekly number. Weekly number of RFBM determined as missing for <4 days of information.|8 weeks|Patients who continued into the open-label period and received at least 1 dose of test article. Observed case analysis.||bowel movements||Standard Deviation|Mean
747278|NCT00529087|Secondary|Change From Baseline in Weekly Number of Rescue-free Bowel Movements (RFBM) for the Double-blind Period at 4 Weeks|A rescue-free bowel movement defined as a bowel movement with no laxatives use during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were reported daily by patient using a telephone interactive voice response system (IVRS). The weekly number of RFBM was defined as the total number of RFBM reported during the double-blind period divided by the number of days the patient reported diary information in that period, and then multiplied by 7 to normalize to a weekly number.|Baseline and 4 weeks|Patients who were randomized and received at least 1 dose of double-blinded test article. Last observation carried forward (LOCF).||bowel movements||Standard Error|Mean
747450|NCT00530023|Secondary|Incidence of Severe Hypoglycemia Events Baseline to Week 15|The total number of severe hypoglycemia events, defined as episodes requiring assistance from another person (i.e., subject is unable to treat self and requires carbohydrate or glucagon or other resuscitative actions) compared between the two study arms from Baseline to Week 15.|Baseline and 15 weeks|||number of events|||Number
747279|NCT00529087|Secondary|Time to the First Rescue-free Bowel Movement (RFBM) After First Dose|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS). Responses following first injection were censored at 24 hours or at time of the second injection, which ever occurred first.|up to 24 hours|Patients who were randomized and received at least 1 dose of double-blinded test article.||% of subjects achieving RFBM in 24 hours|||Number
747280|NCT00529087|Primary|Percentage of Active Injections Resulting in Any Rescue-free Bowel Movement (RFBM) Within 4 Hours of Injection During the Double-blind Period|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS). Active injections are those that contain study drug (e.g., daily injections in MOA-728 QD treatment group and every other injection for the MOA-728 QOD treatment group). The corresponding injections in the placebo group were used as controls.|4 weeks|Patients who were randomized and received at least 1 dose of double-blinded test article.||percentage of active injections||Standard Deviation|Mean
747281|NCT00529087|Primary|Percentage of Patients Having a Rescue-free Bowel Movement (RFBM) Within 4 Hours of the First Dose|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS).|up to 4 hours|Patients who were randomized and received at least 1 dose of double-blinded test article. For this analysis, the MOA-728 QD and MOA-728 QOD treatment groups were combined as the treatment regimen was the same through the first dose (day 1).||percentage of participants|||Number
747282|NCT00529100|Secondary|Phase 2: Site of Progressive Disease (PD)|Summarized participants with local (progression within the sites of initial disease)/regional (disease progression adjacent to but not within the site of initial disease at the start of treatment), distant (disease progression that is blood borne to other parts of the body, including outside the chest or involving the contralateral lung), and local + distant sites of disease. Objective PD is defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.0) as at least a 20% increase in the sum of the longest diameter (LD) of target lesions as references the smallest sum LD recorded since treatment started or the appearance of 1 or more new lesions.|Baseline to measured PD (up to 3 years)|The treated population was used for this analysis and included all participants who received at least 1 dose of either study therapy (pemetrexed, cisplatin, or radiation) and who had PD.||participants|||Number
747283|NCT00529100|Secondary|Phase 2: Percentage of Participants With Objective Tumor Response (Response Rate)|Response using Response Evaluation Criteria In Solid Tumors (RECIST 1.0). Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD)=20% increase in sum of longest diameter of target lesions; Stable Disease (SD)=small changes that do not meet above criteria. Objective response rate (%)=number of objective responders divided by the number of participants with measurable disease * 100, where objective responders are those participants who have met criteria either for CR or PR.|Baseline to measured PD (up to 3 years)|The treated population was used for this analysis and included all participants who received at least 1 dose of either study therapy (pemetrexed, cisplatin, or radiation) and with measurable disease.||percentage of participants||95% Confidence Interval|Number
747284|NCT00529100|Secondary|Progression Free Survival (PFS)|PFS was defined as the period from study entry until PD, death, or date of last contact. For participants not known to have died as of the data cut-off date and who did not have PD, the PFS date was censored at the last contact date (contacts considered in the determination of last progression free disease assessment).|Baseline to measured PD (up to 36 months)|The treated population was used for this analysis and included all participants who received at least 1 dose of either study therapy (pemetrexed, cisplatin, or radiation). Eight participants were censored.||months||95% Confidence Interval|Median
747285|NCT00529100|Secondary|Phase 2: Percentage of Participants With Progression Free Survival (PFS)|The percentage of participants not known to have died as of the data cut-off date or last contact and who did not have PD.|Baseline and 1 year and 2 years and 3 years|The treated population was used for this analysis and included all participants who received at least 1 dose of either study therapy (pemetrexed, cisplatin, or radiation).||percentage of participants||95% Confidence Interval|Number
747286|NCT00529100|Secondary|Phase 2: Time to Progressive Disease (PD)|Time to PD was defined as the time from study enrollment to the first date of objective disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.0) as at least a 20% increase in the sum of the longest diameter (LD) of target lesions as references the smallest sum LD recorded since treatment started or the appearance of 1 or more new lesions. Time to PD was censored at the date of death if death was due to other cause. For participants not known to have died as of the data cut-off date and who did not have PD, time to PD was censored at the last progression-free disease assessment. For participants who received subsequent cancer therapy (after discontinuation from the study therapy) before PD, time to PD was censored at the date of subsequent cancer therapy initiation.|Baseline to measured PD (up to 3 years)|The treated population was used for this analysis and included all participants who received at least 1 dose of either study therapy (pemetrexed, cisplatin, or radiation). Eleven participants were censored.||months||95% Confidence Interval|Median
747287|NCT00529100|Secondary|Phase 2: Percentage of Participants With Overall Survival (OS) at 2 Years and 3 Years|OS was defined as the time from date of enrollment to death due to any cause.|Baseline and 2 years and 3 years|The treated population was used for this analysis and included all participants who received at least 1 dose of either study therapy (pemetrexed, cisplatin, or radiation).||percentage of participants||95% Confidence Interval|Number
747288|NCT00529100|Secondary|Phase 1: Number of Participants With Adverse Events (AE; Toxicity)|A listing of AEs is located in the Reported Adverse Event module.|Baseline to measured PD (up to 1 year)|The treated population was used for this analysis and included all participants who received at least 1 dose of either study therapy (pemetrexed, cisplatin, or radiation).||participants|||Number
747451|NCT00530023|Primary|Change in A1C From Baseline to Week 15|Change in A1C measured from Baseline to week 15 will be compared. A1C measured as percent of glycated hemoglobin using a standardized assay for all subjects.|Baseline and 15 weeks|||percent glycated hemoglobin||Standard Deviation|Mean
747289|NCT00529100|Primary|Phase 2: Percentage of Participants With Overall Survival (OS) at 1 Year|OS was defined as the time from date of enrollment to death due to any cause.|Baseline to date of death from any cause (up to 1 year)|The treated population was considered the primary analysis population for the efficacy endpoints. The efficacy analysis was also completed on the protocol-qualified (PQ)population to assess the sensitivity of the results.||percentage of participants||95% Confidence Interval|Number
747290|NCT00529100|Primary|Phase 1: Maximum Tolerated Dose (MTD) of Pemetrexed in Combination With Cisplatin and Radiation Therapy|Recommended Phase 2 MTD was highest dose at which no more than 1 of 6 participants experienced dose level toxicity (DLT). DLT=(1) Grade 3/4 dysphagia/esophagitis, leukopenia, thrombocytopenia, febrile neutropenia, fatigue/malaise, pneumonitis, dermatitis, persistent elevation of bilirubin/alkaline phosphatase/aspartate aminotransferase only if resulting in delay of radiotherapy >1 week, delay of pemetrexed/cisplatin Cycle 2 >2 weeks, or delay of pemetrexed/cisplatin Cycle 3 past 5 weeks after radiotherapy; (2) other Grade 3 or 4 toxicity possibly related to concurrent treatment administration.|Baseline to measured progressive disease (PD; up to 1 year)|The treated population included all participants who received at least 1 dose of either study therapy (that is, pemetrexed, cisplatin, or radiation).||milligrams per square meter (mg/m^2)|||Number
747291|NCT00529126|Secondary|Participants With Adverse Events Through 72 Hours or Serious Adverse Events Through 30 Days||Up to 30 days||||||
747292|NCT00529126|Primary|Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) at Rest (NRS-R) Pain Intensity Scores From 0 Through 72 Hours|To assess pain intensity at rest (NRS-R), the subject was to assume a resting position that did not exacerbate his or her postoperative pain. The subject was to rest in this position for at least 5 minutes before responding to the following question: “On a scale of 0 to 10, where 0=no pain and 10=worst possible pain, how much pain are you having right now?”|0 to 72 hours|||units on a scale*hrs||Standard Deviation|Mean
747293|NCT00529152|Secondary|Change in Serum Ferritin Concentration From Baseline.|The change in serum ferritin concentration from baseline to week 24 was measured and analyzed for all participants in the study|Baseline and 24 weeks|99 subjects had at least one post baseline measurement of serum ferritin concentration and were eligible for the efficacy analyses in the Intent to Treat population (all subjects). The Last Measurement Carried Forward methodology was used to populate any missing serum ferritin value.||ug/L||Standard Deviation|Mean
747294|NCT00529152|Primary|Occurrence of Adverse Events|Number of Adverse Events over 24 weeks|24 Weeks|All subjects enrolled (100), had at least one dose of Ferriprox oral solution, all were included in safety analysis||Adverse Events|||Number
747295|NCT00529191|Secondary|HDL and LDL Cholesterol Levels in Participants Stratified by the Preservation of Islet Cell Function|"Relationship between atorvastatin's effect on HDL and LDL cholesterol and the preservation of islet cell function.
Islet cell preservation defined as: <7.5% Reduction in C-Pep"|Baseline, Week 1, Month 3, Month 6, Month 9, Month 12,|||mg/dl||Standard Deviation|Mean
747296|NCT00529191|Secondary|Study Drug Compliance Rate Overall|Compliance is defined as >=80% expected dosage consumed during the visit period.|12 months treatment|||% of compliant participants|||Number
747297|NCT00529191|Secondary|Number of Episodes of Hypoglycemia Requiring Any Treatment|number of episodes of hypoglycemia requiring any treatment, defined by the need for treatment with glucagon or third party intervention.|Baseline, Month 12, Month 18|All subjects contributing data||episodes||Standard Deviation|Mean
747298|NCT00529191|Secondary|Blood Glucose Control (Number of Participants With Hypoglycemia)|Blood glucose control as determined from home glucose meter downloads for the 1 week preceding the visit. The number of subjects with hypoglycemic episodes requiring treatment (BG < 70 mg/dl)|Baseline, Month 12, Month 18|All participants contributing data||Participants|||Count of Participants
747299|NCT00529191|Secondary|Levels of HbA1c at Months 3, 6, 9, 12 and 18||3, 6, 9, 12, and 18 months|||percentage of glycated hemoglobin||Standard Deviation|Mean
747300|NCT00529191|Secondary|Mean Daily Insulin Dose Per kg Body Weight for 7 Days|Mean daily insulin dose per kg body weight for the 1 week preceding each scheduled study visit.|Visit 1, 2, 3, 4, 5, 6, 7|||units/kg||Standard Deviation|Mean
747301|NCT00529191|Secondary|% Subjects Without Change in 2-hour C-peptide AUC in Response to the MMTT at Baseline vs. 12 Months|The C-peptide AUC measurements are collected over a 2 hour period (with 30 minute intervals) after a Mixed Meal Tolerance Test. The area under the curve from these combined measurements (from 0 to 120 or 0 to 240 minutes) is calculated and the unit of measure is nanogram*minutes/ml. The change in C-peptide AUC in response to a 2 hour MMTT at baseline vs 12 months were calculated, and efficacy (success) is defined as < 7.5% reduction.|Baseline vs 12 months|||% of participants with efficacy|||Number
747302|NCT00529191|Primary|Efficacy of a Daily Dose of Atorvastatin to Maintain Islet Cell Function as Measured by a 4-hour C-peptide Area Under Curve (AUC) in Patients With Newly Diagnosed Type 1 Diabetes Mellitus|The change in C-peptide measurements collected over a 4 hour period (0, 30, 60, 90, 120, 150, 180, 210 and 240 minutes) after a Mixed Meal Tolerance Test at baseline vs 12 months post-treatment were calculated. The area under the curve for these combined measurements is calculated and the unit of measure is nanogram x minutes / mL. Efficacy (success) is defined by < 7.5% reduction in AUC for 4-hr MMTT.|Baseline vs 12-month|Participants who completed their 12-month treatment were included in the analysis, in which the change in C-peptide AUC at baseline and 12-months were calculated. Efficacy (success) is defined by < 7.5% reduction in AUC for 4-hr MMTT.||nanogram*minutes/ml||Standard Deviation|Mean
747303|NCT00529204|Secondary|Safety of Exenatide in Patients With NAFLD and Type 2 Diabetes||24 weeks|||adverse events|||Number
747304|NCT00529204|Secondary|Changes in Components of Liver Histology at Baseline and Week 24 Including Steatosis, Inflammation and Fibrosis|"Steatosis was grades on a scale of 0 (< 5%); 1 (5%- 33%); 2 (> 33% - 66%); and 3 (> 66%).
Inflammation was graded on a scale of 0 (No foci); 1 (< 2 foci per 200 X field); 2 (2-4 foci per 200 X field); and 3 (>4 foci per 200 X field) Fibrosis was graded on a scale of 0 (None); 1 (Mild periportal or perisinusoidal); 2 (Moderate periportal or perisinusoidal); 3 (Bridging fibrosis); and 4 (cirrhosis)"|24 weeks|||units on a scale|||Number
747305|NCT00529204|Primary|Reduction in Serum ALT From Baseline to 24 Weeks of Exenatide Therapy||24 weeks|||IU|||Number
747482|NCT00530335|Secondary|Number of Participants With Potentially Clinically Significant Changes in Vital Signs During the Study|Vital signs reported are Pulse (beats per minute [bpm]), Systolic Blood Pressure (SBP) (mmHg), and Diastolic Blood Pressure (DBP) (mmHg).|over 8 weeks|All enrolled participants.||participants|||Number
747306|NCT00529217|Secondary|Clinical Improvement (CGI-S)|"Minimum CGI-S score: 1 Maximum CGI-S score: 7
Higher scores indicate the presence of high symptom severity. Decrease in scores from baseline reflects clinical symptom improvement.
Patients will be classified as responders with a CGI-S = 1 or 2; and partial responders CGI-S = 3.
= Normal, not at all ill
= Borderline mentally ill
= Mildly ill
= Moderately ill
= Markedly ill
= Severely ill
= Among the most extremely ill patients"|6, 9, or 12 weeks|||responders (CGI-S = 1 or 2)|||Number
747307|NCT00529217|Primary|Cambridge Depersonalization Scale (CDS)|"Change on CDS from baseline. Scale item number: 29 Item score range: Frequency: 0 - 4, Duration: 0-5 Minimum CDS score: 0 Maximum CDS score: 261
Higher scores indicate the presence of high symptom severity. Decrease in scores from baseline reflects clinical symptom improvement."|6, 9, or 12 weeks|||responders (>50% reduction in CDS score)|||Number
747308|NCT00529243|Secondary|Average Change in Cluster of Differentiation 4(CD4) Cell Count From Baseline at Week 24|To study the immunologic effect of changing enfuvirtide to MK-0518 (raltegravir) in HIV-1 infected patients who have an undetectable level of serum HIV (undetectable serum HIV defined as < 75 copies/ml by bDNA assay or < 50 copies/ml by Ultrasensitive PCR assay)on their current HIV medication regimen.|24 Weeks|Analysis was per intention to treat (ITT) population defined as all patients who received at least one dose of raltegravir.||cells/mm^3||Full Range|Mean
747309|NCT00529243|Primary|Number of Patients With Undetectable Human Immunodeficiency Virus (HIV) Viral Load at Week 24.|To assess the virologic effect of changing enfuvirtide to MK-0518 (raltegravir) in human immunodeficiency virus type 1 (HIV-1) infected patients who have an undetectable level of serum HIV (undetectable level of serum HIV defined as < 75 copies/ml by bDNA assay or < 50 copies/ml by Ultrasensitive PCR assay) on their current HIV medication regimen.|24 Weeks|Analysis used the intent to treat (ITT) population, defined as all patients who received at least one dose of raltegravir.||participants|||Number
747310|NCT00529282|Secondary|Clinical Cure Without Prophylactic Antibiotics After the End-of-treatment (EOT) Visit up to 28 Days of Study Drug|To demonstrate the noninferiority of ceftobiprole compared with cefepime with or without vancomycin with regard to clinical cure at the primary efficacy visit after completing the unmodified initial course of therapy, and receiving no prophylactic antibiotics after the EOT visit.|7 to 10 days after end of therapy or before 24 hours of the initiation of the next course of chemotherapy, whichever is shorter.|No outcome measures were analyzed due to early termination of the study.|||||
747311|NCT00529282|Secondary|Clinical Success at 72 Hours|To compare the clinical success rate (absence or improvement of signs and symptoms of infection) at 72 hours after starting ceftobiprole with that of cefepime with or without vancomycin|72 hours after starting study drug|No outcome measures were analyzed due to early termination of the study.|||||
747312|NCT00529282|Secondary|Clinical Cure Regardless of Modification of Therapy|To demonstrate the noninferiority of ceftobiprole compared with cefepime with or without vancomycin with regard to clinical cure at the primary efficacy visit after completing the initial course of therapy, regardless of modification of therapy defined as addition of an anti-fungal agent and/or an aminoglycoside. Cure with modification: The subject requires antifungals, which will be considered a failure for the primary endpoint. The subject needs modification of study therapy by adding one or more agents (other than protocol-defined chemoprophylaxis antibiotics).|7 to 10 days after end of therapy or before 24 hours of the initiation of the next course of chemotherapy, whichever is shorter.|No outcome measures were analyzed due to early termination of the study.|||||
747313|NCT00529282|Primary|Clinical Cure Rate of Ceftobiprole vs Comparator in Patients With Fever and Neutropenia.|Clinical cure rate (the ratio of the number of clinically cured patients to the total number of patients in the population) at 7 to 10 days after end of therapy or before 24 hours of the initiation of the next course of chemotherapy, whichever is shorter. Cure without modification: A subject will be considered to be cured at the primary efficacy visit if: The subject’s fever and clinical signs and symptoms are resolved to the extent that no further anti-infective therapy is necessary as determined by the investigator Any infecting organisms that were identified at baseline were eradicated|7 to 10 days after end of therapy or before 24 hours of the initiation of the next course of chemotherapy, whichever is shorter.|No outcome measures were analyzed due to early termination of the study.|||||
747314|NCT00529308|Primary|"Number of Patients With Improved or Minimally Improved in Clinical Global Impression-Improvement (CGI) Scale"|The CGI-I is a clinician-rated scales that have been used in clinical trials for over 25 years. Clinicians rate patient improvement compared to baseline. By convention, 4 = No Change; scores of 5, 6, and 7 move in the direction of worsening; scores of 3, 2, and 1 correspond to “Minimal Improvement,” “Much Improved” or “Very Much Improved,” respectively. CGI-I ratings of “Much” or “Very Much Improved” at post-treatment are used to identify treatment responders.|3 weeks|||participants|||Number
747315|NCT00529308|Primary|Motor Cortex Excitability Normalization-Left Motor Threshold|Motor Threshold (MT) is thought to be a measure of membrane excitability in pyramidal neurons. MT is defined as the minimum magnetic flux needed to elicit a threshold EMG response (50 µV in peak to peak amplitude) in a resting target muscle in 5 out of 10 trials using single pulse TMS administered to the contralateral primary motor cortex. MT for both right and left hand are determined, and the lowest is used to select the intensity for rTMS.|3 weeks|This data was only available for the subjects at the Yale site only.||µV||Standard Deviation|Mean
747316|NCT00529308|Primary|"Number of Patients With Much Improved or Very Much Improved on Clinical Global Impression-Improvement (CGI) Scale"|The CGI-I is a clinician-rated scales that have been used in clinical trials for over 25 years. Clinicians rate patient improvement compared to baseline. By convention, 4 = No Change; scores of 5, 6, and 7 move in the direction of worsening; scores of 3, 2, and 1 correspond to “Minimal Improvement,” “Much Improved” or “Very Much Improved,” respectively. CGI-I ratings of “Much” or “Very Much Improved” at post-treatment are used to identify treatment responders.|3 weeks|||participants|||Number
747317|NCT00529308|Primary|Motor Cortex Excitability Normalization-Right Motor Threshold|Motor Threshold (MT) is thought to be a measure of membrane excitability in pyramidal neurons. MT is defined as the minimum magnetic flux needed to elicit a threshold EMG response (50 µV in peak to peak amplitude) in a resting target muscle in 5 out of 10 trials using single pulse TMS administered to the contralateral primary motor cortex. MT for both right and left hand are determined, and the lowest is used to select the intensity for rTMS.|3 weeks|This data was only available for the subjects at the Yale site only.||µV||Standard Deviation|Mean
747318|NCT00529308|Primary|Yale Global Tic Severity Scale (Y-GTSS)|Y-GTSS is a clinician-rated scale used to assess tic severity. Motor and phonic tics are rated separately from 0 to 5 on several scales including number, frequency, intensity, complexity, and interference. Thus Motor and Phonic Tic scores can range from 0 to 25; the combined Total Tic Score ranges from 0 to 50. There is also an Impairment score that rates the overall burden due to tics. The Impairment scale yields a single score from 0 to 50 with higher scores indicating higher levels of overall impairment associated with tics.|3 weeks|||units on a scale||Standard Deviation|Mean
747319|NCT00529399|Primary|The Primary Outcome is the Area Under the Stimulated C-peptide Curve (AUC) at the One Year Visit|The primary outcome is the area under the stimulated C-peptide curve (AUC) based on data collected at time 0 to 2 hours of a 4-hour mixed meal glucose tolerance test (MMTT) conducted at the primary endpoint visit. The timed measurements are done at: 0, 15, 30 60, 90, and 120 minutes.|Based on mixed meal tolerance test (MMTT) conducted at the one year visit|||nmol/L||95% Confidence Interval|Geometric Mean
747320|NCT00529451|Primary|Non-inferiority of Aliskiren 75 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP)|To evaluate the non-inferiority of aliskiren 75 mg to ramipril 5 mg in the change in Mean Sitting Diastolic Blood Pressure (msDBP) from baseline to 8 week endpoint|Baseline and Week 8|Intent-to-treat. Analyzed patients received at least one dose of study drug and had a post baseline measurement.||mm Hg||Standard Error|Least Squares Mean
747321|NCT00529451|Primary|Non-inferiority of Aliskiren 150 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP)|To evaluate the non-inferiority of aliskiren 300 mg to ramipril 5 mg in the change in Mean Sitting Diastolic Blood Pressure (msDBP) from baseline to 8 week endpoint|Baseline and Week 8|Intent-to-treat. Analyzed patients received at least one dose of study drug and had a post baseline measurement.||mm Hg||Standard Error|Least Squares Mean
747322|NCT00529451|Primary|Non-inferiority of Aliskiren 300 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP)|To evaluate the non-inferiority of aliskiren 300 mg to ramipril 5 mg in the change in Mean Sitting Diastolic Blood Pressure (msDBP) from baseline to 8 week endpoint|Baseline and Week 8|Intent-to-treat. Analyzed patients received at least one dose of study drug and had a post baseline measurement.||mm Hg||Standard Error|Least Squares Mean
747323|NCT00529451|Secondary|Evaluation of the Percentage of Responders on Aliskiren 300 mg, 150 mg and 75 mg vs. Ramipril 5 mg, Define as msDBP < 90 mmHg or ≥ 10mmHg Decrease From Baseline in msDBP|To evaluate the percentage of responders on aliskiren 300 mg, 150 mg and 75 mg vs. ramipril 5 mg, defined as msDBP < 90 mmHg or ≥ 10mmHg decrease from baseline in msDBP.|Week 8|Intent-to-treat. Analyzed patients received at least one dose of study drug and had a post baseline measurement.||Percentage of participants|||Number
747324|NCT00529451|Secondary|Evaluation of the Percentage of Patients Controlled to a Target Blood Pressure of < 140/90 mmHg on Aliskiren 300 mg, 150 mg and 75 mg vs. Ramipril 5 mg|To evaluate the percentage of patients controlled to a target blood pressure of < 140/90 mmHg on aliskiren 300 mg, 150 mg and 75 mg vs. ramipril 5 mg.|Week 8|Intent-to-treat. Analyzed patients received at least one dose of study drug and had a post baseline measurement.||Percentage of participants|||Number
747325|NCT00529451|Secondary|Change in Mean Sitting Systolic Blood Pressure (msSBP)and Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to 8 Week Endpoint|To evaluate the change in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic blood Pressure (msDBP) from baseline to 8 week endpoint on aliskiren 300 mg, 150 mg and 75 mg vs. ramipril 5 mg in patients with essential hypertension.|Baseline and Week 8|Intent-to-treat. Analyzed patients received at least one dose of study drug and had a post baseline measurement.||mm Hg||Standard Error|Least Squares Mean
747326|NCT00529464|Primary|Number of Unnecessary Loop Electrosurgical Excision Procedures (LEEP)|A LEEP is unnecessary if histological examination results in diagnosis of low grade squamous intraepithelial lesion or normal. Comparison of 3 arms (colposcopy to colposcopy + spectroscopy, colposcopy + LEEP Procedure) in the diagnostic setting, stratifying participants by outside Papanicolaou (Pap) smear of low grade and high grade squamous intraepithelial lesions, and to use multispectral digital colposcopy retrospectively, in identifying unnecessary LEEPs performed.|Up to 2 years|The primary outcome measure could not be assessed because no subject received randomized treatment assignment. The study was terminated.|||||
747327|NCT00529516|Secondary|Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least TNF-α and Another Immune Marker|Results are presented as the geometric mean number of IFN-γ -positive CD8 T-cells (per million CD8 T-cells) for pooled vaccine strains. Other immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L) and interferon gamma (IFN-γ).|At Day 0 and 21|The analysis was performed on the ATP cohort of immunogenicity Cell-Mediated Immunity (CMI) which included a subset of subjects from the ATP Cohort for immunogenicity HI. This included subjects for whom data for immune response marker-positive CD8 result was available 21 days after vaccination.||Cells per million||Standard Deviation|Geometric Mean
747328|NCT00529516|Secondary|Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least IL-2 and Another Immune Marker|Results are presented as the geometric mean number of IFN-γ -positive CD8 T-cells (per million CD8 T-cells) for pooled vaccine strains. Other immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L), tumor necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ).|At Day 0 and 21|The analysis was performed on the ATP cohort of immunogenicity Cell-Mediated Immunity (CMI) which included a subset of subjects from the ATP Cohort for immunogenicity HI. This included subjects for whom data for immune response marker-positive CD8 result was available 21 days after vaccination.||Cells per million||Standard Deviation|Geometric Mean
747329|NCT00529516|Secondary|Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least IFN-γ and Another Immune Marker|Results are presented as the geometric mean number of IFN-γ -positive CD8 T-cells (per million CD8 T-cells) for pooled vaccine strains. Other immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L), interleukin-2 (IL-2) and tumor necrosis factor alpha (TNF-α).|At Day 0 and 21|The analysis was performed on the ATP cohort of immunogenicity Cell-Mediated Immunity (CMI) which included a subset of subjects from the ATP Cohort for immunogenicity HI. This included subjects for whom data for immune response marker-positive CD8 result was available 21 days after vaccination.||Cells per million||Standard Deviation|Geometric Mean
747572|NCT00530842|Secondary|Forced Expiratory Volume in 1 Second (FEV1)|Post-dose percent predicted FEV1 (Forced Expiratory Volume in 1 second) according to ECCS after 4 weeks (measured by spirometry)|4 weeks|FAS using imputed values||Percent of predicted FEV1||Standard Error|Mean
747330|NCT00529516|Secondary|Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least CD40L and Another Immune Marker|Results are presented as the geometric mean number of CD40L-positive CD8 T-cells (per million CD8 T-cells) for pooled vaccine strains. Other immune markers assessed include interleukin-2 (IL-2), tumor necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ).|At Day 0 and 21|The analysis was performed on the ATP cohort of immunogenicity Cell-Mediated Immunity (CMI) which included a subset of subjects from the ATP Cohort for immunogenicity HI. This included subjects for whom data for immune response marker-positive CD8 result was available 21 days after vaccination.||Cells per million||Standard Deviation|Geometric Mean
747331|NCT00529516|Secondary|Number of Cluster of Differentiation 8 (CD8) T-cells (Per Million CD8 T-cells) Expressing at Least 2 Different Immune Markers|Results are presented as the geometric mean number of immune response marker-positive CD8 T-cells (per million CD8 T-cells) for pooled vaccine strains. Immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L), interleukin-2 (IL-2), tumor necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ).|At Day 0 and 21|The analysis was performed on the ATP cohort of immunogenicity Cell-Mediated Immunity (CMI) which included a subset of subjects from the ATP Cohort for immunogenicity HI. This included subjects for whom data for immune response marker-positive CD8 result was available 21 days after vaccination.||Cells per million||Standard Deviation|Geometric Mean
747332|NCT00529516|Secondary|Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least TNF-α and Another Immune Marker|Results are presented as the geometric mean number of IFN-γ -positive CD4 T-cells (per million CD4 T-cells) for pooled vaccine strains. Other immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L) and interferon gamma (IFN-γ).|At Day 0 and 21|The analysis was performed on the ATP cohort of immunogenicity Cell-Mediated Immunity (CMI) which included a subset of subjects from the ATP Cohort for immunogenicity HI. This included subjects for whom data for immune response marker-positive CD4 result was available 21 days after vaccination.||Cells per million||Standard Deviation|Geometric Mean
747333|NCT00529516|Secondary|Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least IL-2 and Another Immune Marker|Results are presented as the geometric mean number of IFN-γ -positive CD4 T-cells (per million CD4 T-cells) for pooled vaccine strains. Other immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L), tumor necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ).|At Day 0 and 21|The analysis was performed on the ATP cohort of immunogenicity Cell-Mediated Immunity (CMI) which included a subset of subjects from the ATP Cohort for immunogenicity HI. This included subjects for whom data for immune response marker-positive CD4 result was available 21 days after vaccination.||Cells per million||Standard Deviation|Geometric Mean
747334|NCT00529516|Secondary|Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least IFN-γ and Another Immune Marker|Results are presented as the geometric mean number of IFN-γ -positive CD4 T-cells (per million CD4 T-cells) for pooled vaccine strains. Other immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L), interleukin-2 (IL-2) and tumor necrosis factor alpha (TNF-α).|At Day 0 and 21|The analysis was performed on the ATP cohort of immunogenicity Cell-Mediated Immunity (CMI) which included a subset of subjects from the ATP Cohort for immunogenicity HI. This included subjects for whom data for immune response marker-positive CD4 result was available 21 days after vaccination.||Cells per million||Standard Deviation|Geometric Mean
747335|NCT00529516|Secondary|Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least CD40L and Another Immune Marker|Results are presented as the geometric mean number of CD40L-positive CD4 T-cells (per million CD4 T-cells) for pooled vaccine strains. Other immune markers assessed include interleukin-2 (IL-2), tumor necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ).|At Day 0 and 21|The analysis was performed on the ATP cohort of immunogenicity Cell-Mediated Immunity (CMI) which included a subset of subjects from the ATP Cohort for immunogenicity HI. This included subjects for whom data for immune response marker-positive CD4 result was available 21 days after vaccination.||Cells per million||Standard Deviation|Geometric Mean
747336|NCT00529516|Secondary|Number of Cluster of Differentiation 4 (CD4) T-cells (Per Million CD4 T-cells) Producing at Least 2 Different Immune Markers|Results are presented as the geometric mean number of immune response marker-positive CD4 T-cells (per million CD4 T-cells) for pooled vaccine strains. Immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L), interleukin-2 (IL-2), tumor necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ).|At Day 0 and 21|The analysis was performed on the ATP cohort of immunogenicity Cell-Mediated Immunity (CMI) which included a subset of subjects from the ATP Cohort for immunogenicity HI. This included subjects for whom data for immune response marker-positive CD4 result was available 21 days after vaccination.||Cells per million||Standard Deviation|Geometric Mean
747337|NCT00529516|Secondary|Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains|A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to1:40 that is usually accepted as indicating protection. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.|At Days 0 and 21|The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity haemagglutination-inhibition (HI) which included all evaluable subjects who complied with the protocol up to the end of the active phase, for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
747338|NCT00529516|Secondary|Seroconversion Factors for HI Antibodies Against Each of the Three Vaccine Strains|Seroconversion factor was defined as the fold increase in serum HI Geometric Mean Titers post-vaccination compared to Day 0.|At Day 21|The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity haemagglutination-inhibition (HI) which included all evaluable subjects who complied with the protocol up to the end of the active phase, for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Fold increase||95% Confidence Interval|Geometric Mean
747339|NCT00529516|Secondary|Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains|A seroconverted subject was defined as a subject who had either a pre-vaccination titer below1:10 and a post-vaccination titer greater than or equal to1:40 or a pre-vaccination titer greater than or equal to1:10 and at least a four-fold increase in post-vaccination titer. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.|At Day 21|The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity haemagglutination-inhibition (HI) which included all evaluable subjects who complied with the protocol up to the end of the active phase, for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
747340|NCT00529516|Secondary|Serum Hemagglutination-inhibition (HI) Antibody Titers Against Each of the Three Vaccine Strains|Titers were expressed as Geometric Mean Titers. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.|At Days 0 and 21|The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity haemagglutination-inhibition (HI) which included all evaluable subjects who complied with the protocol up to the end of the active phase, for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Titer||95% Confidence Interval|Geometric Mean
747341|NCT00529516|Secondary|Number of Subjects Reporting Any and Related Medically Significant Conditions (MSCs)|Medically significant conditions assessed include conditions prompting emergency room visits, hospitalizations or physician visits.|During the vaccination phase of the study (Day 0 to Day 20) and during the long term follow-up phase of the study (Day 21 to Day 179)|The analysis was performed on the Total Vaccinated Cohort which included all subjects with study vaccine administered.||Subjects|||Number
747342|NCT00529516|Secondary|Number of Subjects With Any and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the vaccination phase of the study (Day 0 to Day 20) and during the long term follow-up phase of the study (Day 21 to Day 179)|The analysis was performed on the Total Vaccinated Cohort which included all subjects with study vaccine administered.||Subjects|||Number
747343|NCT00529516|Primary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any: any AE regardless of intensity or relationship to vaccination. Grade 3: AE that prevented normal activity. Related: AE considered by the investigator to be causally related to the study vaccination.|During a 21-day follow-up period after vaccination|The analysis was performed on the Total Vaccinated Cohort which included all subjects with study vaccine administered.||Subjects|||Number
747344|NCT00529516|Primary|Duration of Solicited General Adverse Events|Duration was expressed as the median number of days the symptom was experienced.|During a 7-day follow-up period after vaccination|The analysis was performed on the Total Vaccinated Cohort, on subjects that experienced the specific symptom.||Days||Full Range|Median
747345|NCT00529516|Primary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs)|Solicited general AEs assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any: any symptom regardless of intensity grade; any fever: oral temperature greater than or equal to 38 degrees Celsius (°C). Grade 3: symptoms that prevented normal activity ; Grade 3 fever: oral temperature greater than 40°C. Related: symptom assessed by the investigator as causally related to the study vaccination.|During a 7-day follow-up period after vaccination|The analysis was performed on the Total Vaccinated Cohort on subjects who completed the symptom sheet.||Subjects|||Number
747346|NCT00529516|Primary|Duration of Solicited Local Adverse Events|Duration was expressed as the median number of days the symptom was experienced.|During a 7-day follow-up period after vaccination|The analysis was performed on the Total Vaccinated Cohort, on subjects that reported the specific symptom.||Days||Full Range|Median
747347|NCT00529516|Primary|Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)|Solicited local AEs assessed include ecchymosis, pain, redness and swelling. Any: any symptom regardless of intensity grade. Grade 3 pain: considerable pain at rest, which prevented normal everyday activities. Grade 3 ecchymosis, redness and swelling: more than 100 millimeter.|During a 7-day follow-up period after vaccination|The analysis was performed on the Total Vaccinated Cohort on subjects who completed the symptom sheet.||Subjects|||Number
747348|NCT00529529|Secondary|Number of Asthma Exacerbations Per Patient (Without Imputation) During the 26 Weeks of the Study|An asthma exacerbation was defined as a worsening of asthma as judged clinically significant by the physician, requiring treatment with rescue oral or intravenous (IV) corticosteroids. The number of asthma exacerbations includes events recorded on the asthma exacerbation clinical report form (CRF) page and events recorded on the adverse events CRF page with “asthma” as a key word in the preferred term.|Baseline (Day 1) to end of study (Week 26)|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug.||Asthma exacerbations||Standard Deviation|Mean
747349|NCT00529529|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at Week 12 + 1 Day, Day 85|FEV1 (in liters, L) was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at Week 12, Day 85. The analysis included baseline FEV1 and FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening as covariates.|24 hours post-dose at Week 12 + 1 day, Day 85|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Participants with observations at Day 85 were included in the analysis.||Liters||Standard Error|Least Squares Mean
747350|NCT00529529|Primary|Percentage of Patients With Clinically Significant Asthma Exacerbations During the 26 Weeks of the Study|A clinically significant asthma exacerbation was defined as a worsening of asthma as judged clinically significant by the physician, requiring treatment with systemic corticosteroids. This includes events recorded on the asthma exacerbation clinical report form (CRF) page and events recorded on the adverse events CRF page with “asthma” as a key word in the preferred term.|Baseline (Day 1) to end of study (Week 26)|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug.||Percentage of patients|||Number
747351|NCT00529529|Primary|Blood Glucose 1 Hour Post-dose at Week 12|Blood glucose (in millimoles per liter, mmol/L) was measured from venous blood samples. Samples were sent to a central laboratory for analysis. The analysis included baseline blood glucose and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.|Week 12|Safety population: All patients who received at least one dose of study drug. Participants with observations at week 12 were included in the analysis.||mmol/L||Standard Error|Least Squares Mean
747573|NCT00530842|Secondary|Forced Expiratory Volume in 1 Second (FEV1)|Post-dose percent predicted FEV1 (Forced Expiratory Volume in 1 second) according to ECCS after 8 weeks (measured by spirometry)|8 weeks|FAS using imputed values||Percent of predicted FEV1||Standard Error|Mean
747594|NCT00530842|Secondary|Static Lung Volumes|Trough TLC (Total Lung Capacity) after 4 weeks (measured by bodyphlethysmography)|4 weeks|FAS using imputed values||Litres||Standard Error|Mean
747352|NCT00529529|Primary|Blood Glucose 1 Hour Post-dose at Day 1|Blood glucose (in millimoles per liter, mmol/L) was measured from venous blood samples. Samples were sent to a central laboratory for analysis. The analysis included baseline blood glucose and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.|Day 1|Safety population: All patients who received at least one dose of study drug. Participants with observations at Day 1 were included in the analysis.||mmol/L||Standard Error|Least Squares Mean
747353|NCT00529529|Primary|Serum Potassium 1 Hour Post-dose at Week 12|Serum potassium (in millimoles per liter, mmol/L) was measured from venous blood samples. Samples were sent to a central laboratory for analysis. The analysis included baseline serum potassium and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.|Week 12|Safety population: All patients who received at least one dose of study drug. Participants with observations at week 12 were included in the analysis.||mmol/L||Standard Error|Least Squares Mean
747354|NCT00529529|Primary|Serum Potassium 1 Hour Post-dose at Day 1|Serum potassium (in millimoles per liter, mmol/L) was measured from venous blood samples. Samples were sent to a central laboratory for analysis. The analysis included baseline serum potassium and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.|Day 1|Safety population: All patients who received at least one dose of study drug. Participants with observations at Day 1 were included in the analysis.||mmol/L||Standard Error|Least Squares Mean
747355|NCT00529529|Primary|24 Hour Mean Heart Rate Determined From ECG Holter Monitoring at Week 26|Continuous 24 hour electrocardiography (Holter monitoring) was conducted in a subset of patients at designated study centers, and was used to calculate the mean heart rate (in beats per minute, bpm). Patients returned the Holter monitor recorder to the clinic the morning after the 24 hour recording was complete. The results of Holter monitoring were processed centrally. The analysis included baseline 24 hour mean heart rate and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.|Week 26|Safety population: All patients who received at least one dose of study drug. Participants with observations at week 26 were included in the analysis.||bpm||Standard Error|Least Squares Mean
747356|NCT00529529|Primary|24 Hour Mean Heart Rate Determined From ECG Holter Monitoring at Week 12|Continuous 24 hour electrocardiography (Holter monitoring) was conducted in a subset of patients at designated study centers, and was used to calculate the mean heart rate (in beats per minute, bpm). Patients returned the Holter monitor recorder to the clinic the morning after the 24 hour recording was complete. The results of Holter monitoring were processed centrally. The analysis included baseline 24 hour mean heart rate and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.|Week 12|Safety population: All patients who received at least one dose of study drug. Participants with observations at week 12 were included in the analysis.||bpm||Standard Error|Least Squares Mean
747357|NCT00529529|Primary|Corrected QT (QTc) Interval Using Fridericia's Formula Measured 1 Hour Post-dose at Week 21|The QTc interval (in milliseconds, ms) is calculated from electrocardiogram (ECG) data collected 1 hour post-dose using Fridericia's formula: QTc = QT/RR^0.33. QTc is the interval between the Q and T waves corrected for heart rate and RR is the interval between two R waves. ECGs included all 12 standard leads and a Lead II rhythm strip of at least 10-second duration. All results were sent to a central laboratory for review by a cardiologist. The analysis included baseline QTc interval and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.|Week 21|Safety population: All patients who received at least one dose of study drug. Participants with observations at week 21 were included in the analysis.||ms||Standard Error|Least Squares Mean
747358|NCT00529529|Primary|Corrected QT (QTc) Interval Using Fridericia's Formula Measured 1 Hour Post-dose at Week 12|The QTc interval (in milliseconds, ms) is calculated from electrocardiogram (ECG) data collected 1 hour post-dose using Fridericia's formula: QTc = QT/RR^0.33. QTc is the interval between the Q and T waves corrected for heart rate and RR is the interval between two R waves. ECGs included all 12 standard leads and a Lead II rhythm strip of at least 10-second duration. All results were sent to a central laboratory for review by a cardiologist. The analysis included baseline QTc interval and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.|Week 12|Safety population: All patients who received at least one dose of study drug. Participants with observations at week 12 were included in the analysis.||ms||Standard Error|Least Squares Mean
747359|NCT00529529|Primary|Corrected QT (QTc) Interval Using Fridericia’s Formula Measured 1 Hour Post-dose at Day 1|The QTc interval (in milliseconds, ms) is calculated from electrocardiogram (ECG) data collected 1 hour post-dose using Fridericia's formula: QTc = QT/RR^0.33. QTc is the interval between the Q and T waves corrected for heart rate and RR is the interval between two R waves. ECGs included all 12 standard leads and a Lead II rhythm strip of at least 10-second duration. All results were sent to a central laboratory for review by a cardiologist. The analysis included baseline QTc interval and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.|Day 1|Safety population: All patients who received at least one dose of study drug. Participants with observations at Day 1 were included in the analysis.||ms||Standard Error|Least Squares Mean
747360|NCT00529529|Primary|Diastolic Blood Pressure 1 Hour Post-dose at Week 12|Diastolic blood pressure measurements (in millimeters of mercury, mmHg) were made 1 hour post-dose after the patient had rested in the sitting position for at least 10 minutes. Measurements were made using an inflatable cuff around the upper arm. Phase V Korotkoff sounds were used for determination of diastolic pressure. The analysis included baseline diastolic blood pressure and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.|Week 12|Safety population: All patients who received at least one dose of study drug. Participants with observations at week 12 were included in the analysis.||mmHg||Standard Error|Least Squares Mean
747361|NCT00529529|Primary|Diastolic Blood Pressure 1 Hour Post-dose at Day 1|Diastolic blood pressure measurements (in millimeters of mercury, mmHg) were made 1 hour post-dose after the patient had rested in the sitting position for at least 10 minutes. Measurements were made using an inflatable cuff around the upper arm. Phase V Korotkoff sounds were used for determination of diastolic pressure. The analysis included baseline diastolic blood pressure and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.|Day 1|Safety population: All patients who received at least one dose of study drug. Participants with observations at Day 1 were included in this analysis.||mmHg||Standard Error|Least Squares Mean
747595|NCT00530842|Secondary|Static Lung Volumes|Trough TLC (Total Lung Capacity) after 8 weeks (measured by bodyphlethysmography)|8 weeks|FAS using imputed values||Litres||Standard Error|Mean
747362|NCT00529529|Primary|Systolic Blood Pressure 1 Hour Post-dose at Week 12|Systolic blood pressure measurements (in millimeters of mercury, mmHg) were made 1 hour post-dose after the patient had rested in the sitting position for at least 10 minutes. Measurements were made using an inflatable cuff around the upper arm. The analysis included baseline systolic blood pressure and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.|Week 12|Safety population: All patients who received at least one dose of study drug. Participants with observations at week 12 were included in the analysis.||mmHg||Standard Error|Least Squares Mean
747363|NCT00529529|Primary|Systolic Blood Pressure 1 Hour Post-dose at Day 1|Systolic blood pressure measurements (in millimeters of mercury, mmHg) were made 1 hour post-dose after the patient had rested in the sitting position for at least 10 minutes. Measurements were made using an inflatable cuff around the upper arm. The analysis included baseline systolic blood pressure and forced expiratory volume in 1 second (FEV1) pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.|Day 1|Safety population: All patients who received at least one dose of study drug. Participants with observations at Day 1 were included in the analysis.||mmHg||Standard Error|Least Squares Mean
747364|NCT00529529|Primary|Percentage of Patients With at Least 1 Adverse Event During the 26 Weeks of the Study|Adverse events include asthma exacerbations. An asthma exacerbation was defined as a worsening of asthma as judged clinically significant by the physician, requiring treatment with rescue oral or intravenous (IV) corticosteroids. Asthma worsening that required treatment with inhaled or nebulized short-acting β2-agonists or an increase in inhaled corticosteroids only was not considered an asthma exacerbation.|Baseline (Day 1) to end of study (Week 26)|Safety population: All patients who received at least one dose of study drug.||Percentage of patients|||Number
747365|NCT00529542|Post-Hoc|Body Mass Index||baseline and 6 weeks|All analyses were performed by intention-to-treat.||kg/m2||Standard Deviation|Mean
747366|NCT00529542|Post-Hoc|Mean Ovarian Volume|Pelvic ultrasound was performed using the 6.5 megahertz (MHz) probe of an ATL 400 machine to characterize ovarian size and morphology. Since in vitro studies demonstrate that statins inhibit ovarian theca-interstitial cell proliferation, we hypothesized that statins might reduce ovarian volume in PCOS.|baseline and 6 weeks|All analyses were performed by intention-to-treat.||mm3||Standard Deviation|Mean
747367|NCT00529542|Post-Hoc|Diastolic Blood Pressure||baseline and 6 weeks|All analyses were performed by intention-to-treat.||mm Hg||Standard Deviation|Mean
747368|NCT00529542|Post-Hoc|Systolic Blood Pressure||baseline and 6 weeks|All analyses were performed by intention-to-treat.||mm Hg||Standard Deviation|Mean
747369|NCT00529542|Other Pre-specified|High-sensitivity C-reactive Protein (hsCRP)|high sensitive C-reactive protein as a measure of inflammation|baseline and 6 weeks|All analyses were performed by intention-to-treat.||mg/L||Standard Deviation|Mean
747370|NCT00529542|Secondary|DHEAS|Dehydroepiandrosterone sulfate|baseline and 6 weeks|All analyses were performed by intention-to-treat.||ng/ml||Standard Deviation|Mean
747371|NCT00529542|Secondary|Androstenedione||baseline and 6 weeks|All analyses were performed by intention-to-treat.||ng/ml||Standard Deviation|Mean
747372|NCT00529542|Secondary|Total Testosterone||baseline and 6 weeks|All analyses were performed by intention-to-treat.||ng/dl||Standard Deviation|Mean
747373|NCT00529542|Secondary|AUC for Insulin|Area under the curve for insulin during OGTT: A 75 gram oral glucose tolerance test was performed with blood draws at 0, 30, 60, 90 and 120 minutes.|baseline and 6 weeks|All analyses were performed by intention-to-treat.||uU*minute/mL||Standard Deviation|Mean
747374|NCT00529542|Secondary|Area Under the Curve (AUC) for Glucose During OGTT|A 75 gram oral glucose tolerance test (OGTT) was performed with blood draws at 0, 30, 60, 90 and 120 minutes.|baseline and 6 weeks|All analyses were performed by intention-to-treat.||mg*minute/dL||Standard Deviation|Mean
747375|NCT00529542|Secondary|Fasting Insulin||baseline and 6 weeks|All analyses were performed by intention-to-treat.||uU/ml||Standard Deviation|Mean
747376|NCT00529542|Secondary|Fasting Glucose||baseline and 6 weeks|All analyses were performed by intention-to-treat.||mg/dl||Standard Deviation|Mean
747377|NCT00529542|Secondary|Triglycerides||baseline and 6 weeks|All analyses were performed by intention-to-treat.||mg/dl||Standard Deviation|Mean
747378|NCT00529542|Secondary|HDL Cholesterol||baseline and 6 weeks|All analyses were performed by intention-to-treat.||mg/dl||Standard Deviation|Mean
747379|NCT00529542|Secondary|LDL Cholesterol||baseline and 6 weeks|All analyses were performed by intention-to-treat.||mg/dl||Standard Deviation|Mean
747380|NCT00529542|Secondary|Total Cholesterol||baseline and 6 weeks|All analyses were performed by intention-to-treat.||mg/dl||Standard Deviation|Mean
747381|NCT00529542|Secondary|Peak Brachial Artery Conductance (BAC)|Pneumatic cuffs were positioned on the upper arm and wrist of the experimental arm. The brachial artery was imaged using an ATL Doppler ultrasound probe (5–12MHz linear array scanhead, HDI 5000, Advanced Technology Laboratories, Bothell, WA). Mean blood flow velocity (MBV) and brachial artery diameter (BAD) were recorded at baseline. Then the wrist cuff was inflated to 200–250 mmHg. After a minute, with the wrist cuff still inflated, the arm cuff was inflated to 200–250 mmHg. After 10 minutes the arm cuff was released to induce reactive hyperemia in the brachial artery. Upon release of the arm cuff, we continuously measured blood pressure (BP), heart rate (HR), and MBV, and intermittently measured BAD in the experimental arm. Brachial artery conductance (BAC)was calculated as MBV/MAP and FMD was calculated as percent change in BAD from baseline.|baseline and 6 weeks|All analyses were performed by intention-to-treat.||ml/sec/mm Hg||Standard Deviation|Mean
747382|NCT00529542|Primary|Brachial Artery Flow-mediated Dilation (FMD)|Brachial artery FMD, the percent change in brachial artery diameter following release of transient occlusion, was selected as the primary outcome because it is the most widely used research tool for evaluating the effects of interventions on endothelial function. FMD has been shown to predict longterm cardiovascular events, even in patients with no apparent heart disease.|baseline and 6 weeks|All analyses were performed by intention-to-treat.||% change in brachial artery diameter||Standard Deviation|Mean
747383|NCT00529555|Primary|Change in Pocket Depth.|Average change of Pocket Depth at 9 months from baseline|baseline & 9 months|Intent to treat||mm||95% Confidence Interval|Least Squares Mean
747574|NCT00530842|Secondary|Forced Expiratory Volume in 1 Second (FEV1)|Trough percent predicted FEV1 (Forced Expiratory Volume in 1 second) according to ECCS after 4 weeks (measured by spirometry)|4 weeks|FAS using imputed values||Percent of predicted FEV1||Standard Error|Mean
747384|NCT00529568|Secondary|Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase|The BMI for participants was calculated at the indicated time points as body weight in kilograms divided by height in meters squared. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.|DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)|Safety DB Population. Only those participants contributing data at the indicated time points were analyzed.||Kilograms per meters squared (kg/m^2)||Standard Deviation|Mean
747385|NCT00529568|Secondary|Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase|The weight of participants was recorded at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.|DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)|Safety DB Population. Only those participants contributing data at the indicated time points were analyzed.||Kilograms (kg)||Standard Deviation|Mean
747386|NCT00529568|Secondary|Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase|Heart rate was measured in participants at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.|DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)|Safety DB Population. Only those participants contributing data at the indicated time points were analyzed.||beats per minute||Standard Deviation|Mean
747387|NCT00529568|Secondary|Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase|Participant’s blood pressure was measured at the indicated time points during the study. Systolic blood pressure is a measure of blood pressure while the heart is beating. Diastolic blood pressure is a measure of blood pressure while the heart is relaxed. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.|DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)|Safety DB Population. Only those participants contributing data at the indicated time points were analyzed.||Millimeters of mercury (mmHg)||Standard Deviation|Mean
747388|NCT00529568|Secondary|Number of Participants With CS and NCS Change From Baseline for 12-lead ECG at the Indicated Time Points During the DB Phase|"Duplicate 12-lead ECGs were required at Screening/BL, Antiviral BL, and at 12 weekly intervals during the study. The number of participants with a CS and a NCS change from baseline in ECG status, as determined by the Investigator, was reported. CS, ECG with a CS abnormality that meets exclusion criteria. NCS, ECG with an abnormality not CS or meeting exclusion criteria, per Investigator, based on reasonable standards of clinical judgment. Not applicable indicates that information was not provided by the investigator on whether the change from baseline ECG was CS or NCS."|End of Treatment (up to Week 52); and 24-week FU (up to Week 72)|Safety DB Population. Only those participants contributing data at the indicated time points were analyzed.||participants|||Number
747389|NCT00529568|Secondary|Number of Participants Assessed as Normal and Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points During the DB Phase|Duplicate 12-lead ECGs were required at Screening/BL, Antiviral BL, and at 12 weekly intervals during the study. The number of participants with an ECG status of normal, abnormal, CS, or NCS, as determined by the Investigator, was reported. Normal, all ECG parameters within accepted normal ranges. Abnormal, ECG finding(s) outside of normal ranges. CS, ECG with a CS abnormality that meets exclusion criteria. NCS, ECG with an abnormality not CS or meeting exclusion criteria, per Investigator, based on reasonable standards of clinical judgment.|DB Phase: Antiviral BL (up to Week 10); End of Treatment (up to Week 52); and 24-week FU (up to Week 72)|Safety DB Population. Only those participants contributing data at the indicated time points were analyzed.||participants|||Number
747390|NCT00529568|Secondary|Number of Participants in the Indicated Categories for Cataract Event During the DB Phase, Per Clinical Events Committee (CEC) Adjudication|Ophthalmic (pertaining to eye) assessments were performed during the study. A cataract event is defined as an event ascertained to be a cataract (opacity or cloudiness of the lens of the eye, causing impairment of vision) by at least one of the CEC members (comprised of expert ophthalmologists who provided objective medical review of the blinded ophthalmic data). Per the CEC, cataract events were categorized as: (1) Cataract Progression (CP; progression of cataracts present at BL); and (2) Incident Cataract (IC; development of new cataracts). One eye=unilateral; both eyes=bilateral.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|Safety DB Population||participants|||Number
747391|NCT00529568|Secondary|Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS|Blood samples for the assessment of hematology parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL during the DB Phase are reported, per severity grades by DAIDS, for levels of hemoglobin (low=anemia), lymphocytes (low=lymphocytopenia), total neutrophils (low=neutropenia), and white blood cells (low=leukocytopenia). Per the DAIDS toxicity table, grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|Safety DB Population||participants|||Number
747402|NCT00529568|Secondary|Median Platelet Count at the Indicated Time Points During the DB Phase|Blood taken from peripheral blood vessels was used for the measurement of platelet counts. The Last On Treatment assessment refers to the actual last treatment assessment, not necessarily to the End of Treatment assessment entered by the Investigator.|DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)|ITT Population. Only those participants contributing data at the indicated time points were analyzed.||Gi/L||Full Range|Median
747596|NCT00530842|Secondary|Static Lung Volumes|Post-dose IRV (Inspiratory Reserve Volume) after 4 weeks (measured by bodyphlethysmography)|4 weeks|FAS using imputed values||Litres||Standard Error|Mean
747392|NCT00529568|Secondary|Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS)|Blood samples for the assessment of clinical chemistry parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL during the DB Phase are reported, per severity grades by DAIDS, for levels of calcium (low=hypocalcemia; high=hypercalcemia), glu. (low=hypoglycemia; high=hyperglycemia), pot. (low=hypokalemia; high=hyperkalemia), and sod. (low=hyponatremia; high=hypernatremia). Per the DAIDS toxicity table, the grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|Safety DB Population: all randomized participants who had received study drug in the DB Phase||participants|||Number
747393|NCT00529568|Secondary|Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3)|There are two genetic variants (rs12979860 and rs8099917) mapping near IL28B associated with both interferon-induced SVR and spontaneous HCV clearance. IL28B genotype distribution by response to antiviral therapy (SVR/RVR responders: those who achieved SVR/RVR; SVR/RVR non-responders: those who did not achieve SVR/RVR) was assessed. The effect of genotype was tested by comparing participants that carried 2 copies of the IL28B favorable response allele versus the others (recessive model). Genotypes at rs12979860 were coded as: CC=1, CT or TT=0; rs8099917 was coded as TT=1, GT or GG=0.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|Pharmacogenetic (PGx) Sub-Population: participants enrolled in this study who provided written informed consent for PGx research with a blood sample for genotyping and who were successfully genotyped for at least one of the two genetic markers under study. Only those participants who were analyzed for SVR and RVR were considered.||participants|||Number
747394|NCT00529568|Secondary|Number of Participants Who Prematurely Discontinued Antiviral Therapy in the DB Phase|The following participants were considered to have discontinued antiviral therapy: participants who were lost to follow-up; participants who withdrew for any reason; participants who died; participants who otherwise did not complete their planned course of antiviral therapy for any reason. The planned duration of antiviral therapy was 48 weeks for participants with Non-Genotype 2/3 and 24 or 48 weeks for participants with Genotype 2/3.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|ITT Population||participants|||Number
747395|NCT00529568|Secondary|Number of Participants With the Indicated Levels of Peginterferon Dose Reductions in the DB Phase|The assigned dose in the DB Phase of peginterferon alfa-2a was 180 micrograms (µg). For peginterferon dose modification, downward adjustments in one-level increments were considered. The lowest dose of peginterferon alfa-2a that was allowed to be administered was 45 µg. When dose adjustment was required for moderate to severe adverse reactions (clinical and/or laboratory), an initial dose reduction to 135 µg was generally adequate. In some cases, a dose reduction to 90 µg or 45 µg was necessary. Dose increases toward the original dose were considered when the adverse reaction was resolved.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|ITT Population. One participant could have had more than one dose reduction.||participants|||Number
747396|NCT00529568|Secondary|Time to First Dose Reduction of Peginterferon Alfa-2a and Ribavirin Therapy in the DB Phase|Time to first dose reduction was calculated as the time period from the first dose to the first dose reduction.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|ITT Population. Only those participants with dose reductions were analyzed.||weeks||Standard Deviation|Mean
747397|NCT00529568|Secondary|Number of Participants in the Indicated Categories for Antiviral Therapy Dose Reductions in the DB Phase|Participants were assigned a score equal to the number of times their dose of antiviral therapy (peginterferon or ribavirin) was reduced (0=no dose reductions [DRs]; 1=one DR; 2=two DRs; 3=three DRs; >3=more than three DRs). When possible, every effort was made to maintain the recommended dose of antiviral therapy for the treatment duration in the DB Phase. However, when dose modification of antiviral therapy was required due to safety concerns, it was performed by the Investigator as per the region-specific product labels of peginterferon and ribavirin.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|ITT Population||participants|||Number
747398|NCT00529568|Secondary|Number of Participants With End of Treatment Response (ETR) and Sustained Virological Response at Week 12 of Follow-up (SVR12) During the DB Phase|ETR is defined as the absence of detectable HCV RNA at the end of antiviral treatment. SVR12 is defined as the absence of detectable HCV RNA at the end of antiviral treatment and the 12-week follow-up assessment.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|ITT Population||participants|||Number
747399|NCT00529568|Secondary|Number of Participants With Early Virological Response (EVR) and Complete EVR (cEVR) During the DB Phase|EVR is defined as a clinically significant reduction from Baseline in HCV RNA (>=2 log10 drop or undetectable) after 12 weeks of antiviral treatment. cEVR is defined as undetectable HCV RNA after 12 weeks of antiviral treatment.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|ITT Population||participants|||Number
747400|NCT00529568|Secondary|Number of Participants With Rapid Virological Response (RVR) and Extended RVR (eRVR) During the DB Phase|RVR is defined as the absence of detectable HCV RNA after 4 weeks of antiviral treatment. eRVR is defined as the absence of detectable HCV RNA after 4 weeks of antiviral treatment that persisted through Week 12.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|ITT Population||participants|||Number
747401|NCT00529568|Secondary|Number of Participants in the Indicated Categories for Minimum Platelet Count With Antiviral Therapy|The minimum platelet count with antiviral therapy was categorized as follows: <25 Gi/L; >=25 to <50 Gi/L; >=50 to <90 Gi/L; >=90 to <150 Gi/L; >=150 Gi/L to <200 Gi/L; >=200 Gi/L to <400 Gi/L; and >=400 Gi/L.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|ITT Population||participants|||Number
747403|NCT00529568|Secondary|Median Platelet Count at the Indicated Time Points During the OL Phase|Blood taken from peripheral blood vessels was used for the measurement of platelet counts. The Last On Treatment assessment refers to the actual last treatment assessment, not necessarily to the End of Treatment assessment entered by the Investigator.|OL Phase: Baseline; Day 1; Weeks 1, 2, 3, 4, 5, 6, 7, 8, and 9; Antiviral Baseline (up to Week 10); End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 62); 12-week FU (up to Week 70); and 24-week FU (up to Week 82)|Safety Population. Only those participants contributing data at the indicated time points were analyzed.||Gi/L||Full Range|Median
747404|NCT00529568|Secondary|Number of Participants Receiving the Indicated Doses of Eltrombopag in the OL Phase Who Initiated Antiviral Therapy (Peginterferon Alfa-2a and Ribavirin) in the DB Phase|In the OL Phase, participants initially received the lowest dose of eltrombopag (25 mg QD) for 2 weeks. If after this time the platelet count was <100 Gi/L, participants underwent sequential dose escalation to the next highest dose (50 mg QD for up to 2 weeks), with further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) if platelet counts remained <100 Gi/L. Participants who achieved platelet counts >=100 Gi/L when receiving any of the eltrombopag doses in the OL Phase initiated antiviral therapy in the DB Phase.|From Baseline up to Week 9 in the OL Phase|Safety Population. Participants with a platelet count >=100 Gi/L and who initiated antiviral therapy during the DB Phase were analyzed.||participants|||Number
747405|NCT00529568|Secondary|Number of Participants Whose Platelet Count Increased From a Baseline Count of <75 Gi/L to a Count Greater Than or Equal to (>=) 100 Giga (10^9) Cells Per Liter (Gi/L) During the Open-label (OL) Pre-Antiviral Treatment Phase|Participants were assessed for a shift from a baseline platelet count of <75 Gi/L to a count >=100 Gi/L during the OL Phase (up to 9 weeks). Local laboratories were used for platelet function tests. Platelet counts were measured by blood draw.|From Baseline up to Week 9 in the OL Phase|Safety Population: all participants who had received study drug in the OL Phase||participants|||Number
747406|NCT00529568|Primary|Number of Participants With Sustained Virologic Response (SVR) in the Double-blind (DB) Antiviral Treatment Phase|Participants with SVR are defined as those with non-detectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) at the end of treatment and all subsequent planned visits up to 24 weeks post-completion of the treatment period of the DB Phase.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|Intent-to-Treat (ITT) Population: all participants randomized in the DB Phase||participants|||Number
747407|NCT00529633|Primary|Difference in Serum Prealbumin|"Serum Prealbumin in treated patient and control (no drug) patients were tabulated once weekly for week #1-4 , then once every 4 weeks thereafter at week# 8, 12, 16, 20, 24 to see changes of health status. Final data collected at week 28 -- to ensure patient safety"|28 weeks total|Participant data is not available due to no shipping of specimen to analyzing laboratory|||||
747408|NCT00529633|Primary|Difference in Serum CRP|"Serum CRP in treated patient and control (no drug) patients were tabulated once weekly for week #1-4 , then once every 4 weeks thereafter at week# 8, 12, 16, 20, 24 to see changes of health status. Final data collected at week 28 -- to ensure patient safety"|28 weeks total|||Mg/L CRP|||Number
747409|NCT00529633|Primary|Difference in Serum Albumin|"Serum albumin in treated patient and control (no drug) patients were tabulated once weekly for week #1-4 , then once every 4 weeks thereafter at week# 8, 12, 16, 20, 24 to see changes of health status. Final data collected at week 28 -- to ensure patient safety"|28 weeks total|||g/dL of Albumin|||Number
747410|NCT00529659|Secondary|Change From Baseline in Activity Measure for Post Acute Care (AM-PAC) Physical Movement Score|The Activity Measure for Post Acute Care (AM-PAC) measures function in three domains: basic mobility, daily activities, and applied cognitive function. AM-PAC scores in each functional domain have a mean of 50 with a standard deviation of 10 and scores are distributed along a continuum of function. The AM-PAC tracks outcomes as a participant progresses across an episode of care with higher scores indicating an improved level of functioning.|Baseline, Month 6|N = Number of patient with at least one non-missing measurement at the time point.||Score on a Scale||Standard Deviation|Mean
747411|NCT00529659|Secondary|Change From Baseline in Stair Climbing Power|"Stair-climbing power is an alternate measure of lower extremity muscle strength. Participants were asked to climb a standardized 4-step flight of stairs. The study coordinator timed how long it took the participant to walk up the stairs as quickly as possible. The test starts when the tester says go and ends when both of the patient’s feet are flat on the platform area at the top of the staircase. Participants were permitted to use the railing, and/or an assistive device, if needed. Stair climbing power was calculated as = participant weight × gravity constant × height of stairs / time."|Baseline, Month 6|The FAS included all participants that received at least one dose of the study therapy and had a post-randomization stair climbing power measurement.||watts||Standard Deviation|Mean
747412|NCT00529659|Secondary|Change From Baseline in Participant Gait Speed||Baseline, Month 6|N = Number of participants with at least one non-missing measurement at the time point.||cm/sec||Standard Deviation|Mean
747413|NCT00529659|Primary|Change From Baseline in Bilateral Leg Press (BLP) Measurement|BLP measurements were obtained with the participant sitting on the BLP exercise machine with flexed hips and knees. The participant held the handgrips with hips flexion and knees bent at a 90 degree angle and feet placed evenly on the footpad with heels placed approximately shoulder width apart. Participants were asked to slowly push the footpad forward, while keeping the knees slightly flexed, and bend back again slowly for one repetition. The BLP procedure measures the maximum amount of weight that the patient can push through his or her full range of motion one time.|Baseline, Month 6|N = Number of participants with at least one non-missing measurement at the time point.||lbs||Standard Deviation|Mean
747414|NCT00529659|Secondary|Change From Baseline in Participant Short Physical Performance Battery (SPPB)|The Short Physical Performance Battery (SPPB) is an objective assessment tool for evaluating lower extremity functioning in older persons. The SPPB consists of 3 types of physical maneuvers: balance test, speed gait test, and chair stand test. Results from each maneuvers test are scored on a scale of 0 to 4, with an increasing composite score indicating an improved function level. The total maximum score of SPPB is 12.|Baseline, Month 6|N = Number of participants with at least one non-missing measurement at the time point.||Score on a Scale||Standard Deviation|Mean
747415|NCT00529659|Primary|Change From Baseline in Participant Lean Body Mass||Baseline, Month 6|The full analysis set (FAS) included all participants that received at least one dose of the study therapy and had a post-randomization measurement of lean body mass.||kg||Standard Deviation|Mean
747418|NCT00529763|Secondary|Mean (AUC[0-T]), (AUC[INF]), and (AUC[TAU])of Dasatinib Following 70 mg BID and 100 QD Dose Administration|Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration AUC(0-T)for dasatinib. AUC(INF)=area under the plasma concentration-time curve from time zero extrapolated to infinite time. AUC(TAU)=area under the plasma concentration-time curve for a dosing interval|Day 1 (0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours postdose), Day 8 (0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12 hours postdose)|Number of treated participants with measurement at time point||ng*h/mL||Standard Deviation|Mean
747419|NCT00529763|Secondary|Mean (Tmax) and (T-Half) of Dasatinib Following 70 mg BID and 100 QD Dose Administration|Tmax=time of maximum observed plasma concentration. T-Half=plasma half-life.|Day 1 (0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours postdose), Day 8 (0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12 hours postdose)|Number of treated participants with measurement at time point||hours||Standard Deviation|Mean
747420|NCT00529763|Secondary|Mean Maximum Concentration (Cmax) of Dasatinib Following 70 mg BID and 100 QD Dose Administration|Cmax=maximum observed plasma concentration of dasatinib|Day 1 (0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours postdose), Day 8 (0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12 hours postdose)|Number of treated participants with measurement at time point||ng/mL||Standard Deviation|Mean
747421|NCT00529763|Secondary|Mean Dasatinib Plasma Concentrations|Mean dasatinib plasma concentrations following 70 mg BID dose in AD CML or Ph+ ALL participants and following 100 mg QD dose in CP CML participants|Day 1 (0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours postdose), Days 6 and 7 (0 hours postdose), Day 8 (0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12 hours postdose),|Number of participants analyzed=all treated participants with evaluable PK data; n=number of participants evaluated at time point||ng/mL||Standard Deviation|Mean
747422|NCT00529763|Secondary|Deaths, Serious Adverse Events (SAEs), Adverse Events (AEs), and Grade 3/4 Hematologic Abnormalities|AEs and SAEs considered possibly, probably, or certainly related to study treatment, graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death).SAE= any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization/prolongation of existing hospitalization, results in persistent/significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.|18 months of follow-up from the start of dasatinib treatment (data cut-off date: 18-Jun-2010)|All CP CML, AD CML, and Ph+ ALL Participants||Participants|||Number
747423|NCT00529763|Secondary|Progression-free Survival Among AD CML and Ph+ ALL Participants|The probability to progress after 12 months among AD CML and Ph+ ALL participants. Participants were considered as having Disease Progression (PD) if they: achieved a hematologic response but subsequently no longer meet the criteria consistently on all assessment over a consecutive 2-week period after starting maximum dose; had no decrease from their baseline percent blasts in PB or BM on all assessments over a 4-week period, or had an increase by at least 50% in PB blast count (absolute) over a 2-week period after starting their maximum (individually-tolerated) dose.|12 months of follow-up from the start of dasatinib treatment (data cut-off date: 18-Jun-2010)|All AD CML and Ph+ ALL Participants. Subjects who neither progressed nor died were censored on the date of their last hematologic or cytogenetic assessment.||percentage (probability)||95% Confidence Interval|Number
747424|NCT00529763|Secondary|Duration of MaHR Among AD CML and Ph+ ALL Participants|Durability of MaHR, as measured by the probability of duration of MaHR > 12 months. Major HR (MAHR) includes CHR or no evidence of leukemia (NEL). CHR=white blood cells (WBC) ≤ upper limit of normal (ULN); absolute neutrophil count (ANC) ≥1,000/mm3; platelets ≥100,000/mm3; no blasts/promyelocytes, <20% basophils and <5% myelocytes+metamyelocytes in peripheral blood (PB); BM blasts ≤5%; no extra-medullary involvement/hepatomegaly/splenomegaly. NEL=CHR except platelets ≥20,000/mm3 and <100,000/mm3; ANC >500/mm3 and <1,000/mm3.|Duration of MaHR was measured for AD CML and Ph+ ALL subjects with MaHR from the first day all criteria were met for MaHR until the date of disease progression (PD) or death. (data cut-off date: 18-Jun-2010)|Number of responders. Subjects who neither progressed nor died were censored on the date of their last hematologic assessment.||percentage (probability)||95% Confidence Interval|Number
747425|NCT00529763|Secondary|Duration of CHR Among AD CML and Ph+ ALL Participants|Durability of CHR, as measured by the probability of duration of CHR >12 months. CHR=white blood cells (WBC) ≤ upper limit of normal (ULN); absolute neutrophil count (ANC) ≥1,000/mm3; platelets ≥100,000/mm3; no blasts/promyelocytes, <20% basophils and <5% myelocytes+metamyelocytes in peripheral blood (PB); BM blasts ≤5%; no extra-medullary involvement/hepatomegaly/splenomegaly.|Duration of CHR was measured for AD CML and Ph+ ALL subjects with CHR from the first day all criteria were met for CHR until the date of disease progression (PD) or death.(data cut-off date: 18-Jun-2010)|Number of responders. Subjects who neither progressed nor died were censored on the date of their last hematologic assessment||percentage (probability)||95% Confidence Interval|Number
747426|NCT00529763|Secondary|Time to Complete and Major Hematologic Response (CHR and MaHR) in Advanced Disease Chronic Myeloid Leukemia (AD CML) and Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Participants (Ph+ ALL)|Median time to CHR and MaHR, in weeks. Time to CHR is defined for AD CML and Ph+ALL subjects as the time from first dose of Dasatinib until the first day CHR criteria are met (for all confirmed responses). Time to CHR is computed only for subjects whose best response is CHR. Major HR (MaHR) includes CHR or no evidence of leukemia (NEL). See Outcome Measure 1 for definitions of CHR and MaHR.|12 months of follow-up from the start of dasatinib treatment (data cut-off date: 18-Jun-2010)|Number of Participants Analyzed=All treated participants. n= number of responders.||weeks||Full Range|Median
747427|NCT00529763|Secondary|Progression-free Survival Among CP CML Participants|The probability to progress after 12 months among CP CML participants. Participants were considered as having Disease Progression (PD) if they: achieved a hematologic response but subsequently no longer meet the criteria consistently on all assessment over a consecutive 2-week period after starting maximum dose; had no decrease from their baseline percent blasts in PB or BM on all assessments over a 4-week period, or had an increase by at least 50% in PB blast count (absolute) over a 2-week period after starting their maximum (individually-tolerated) dose.|12 months of follow-up from the start of dasatinib treatment (data cut-off date: 18-Jun-2010)|All CP CML Participants.Subjects who did not progress nor died were censored at their last tumor assessments.||percentage (probability)||95% Confidence Interval|Number
747575|NCT00530842|Secondary|Forced Expiratory Volume in 1 Second (FEV1)|Trough percent predicted FEV1 (Forced Expiratory Volume in 1 second) according to ECCS after 8 weeks (measured by spirometry)|8 weeks|FAS using imputed values||Percent of predicted FEV1||Standard Error|Mean
747428|NCT00529763|Secondary|Duration of Major Cytogenetic Response (MCyR) in Chronic Phase Chronic Myeloid Leukemia (CP - CML) Participants|The Durability of MCyR as measured by the probability of duration of MCyR >12 months. Major Cytogenetic Response (MCyR) = Complete Cytogenetic Response (CCyR: 0% Ph-chromosome-positive cells in metaphase in BM) or Partial Cytogenetic Response (PCyR: 1-35% Ph-chromosome-positive cells in metaphase in BM).|Duration of MCyR was measured for CP CML subjects with MCyR from the first day all criteria were met for CCyR or PCyR until the date of disease progression (PD) or death. (data cut-off date: 18-Jun-2010)|All treated participants in this cohort who were responders. Subjects who did not progress nor died were censored at their last tumor assessments.||percentage (probability)||95% Confidence Interval|Number
747429|NCT00529763|Secondary|Time to Major Cytogenetic Response (MCyR) in Chronic Phase Chronic Myeloid Leukemia (CP - CML) Participants|Time to MCyR is defined for CP CML subjects with MCyR as the time from first dose of dasatinib until the first day criteria for CCyR or PCyR, whichever occurs first. Major Cytogenetic Response (MCyR) is defined as Complete Cytogenetic Response (CCyR: 0% Ph-chromosome-positive cells in metaphase in BM) or Partial Cytogenetic Response (PCyR: 1-35% Ph-chromosome-positive cells in metaphase in BM).|12 months of follow-up from the start of dasatinib treatment (data cut-off date: 18-Jun-2010)|All treated participants in this cohort who were responders.||weeks||Full Range|Median
747430|NCT00529763|Secondary|Percentage of Chronic Phase Chronic Myeloid Leukemia (CP - CML) Participants With Complete Hematologic Response (CHR)|For CP CML, a Complete Hematologic Response (CHR) is obtained when all the following criteria are met: WBC ≤ institutional ULN; platelets ≤ 450,000/mm3; ≤20% basophils in peripheral blood; no blasts or promyelocytes in PB cells; < 5% myelocytes plus metamyelocytes in PB cells; no extra-medullary involvement including no hepatomegaly or splenomegaly.|12 months of follow-up from the start of dasatinib treatment (data cut-off date: 18-Jun-2010)|All treated participants in this cohort||percentage of participants||95% Confidence Interval|Number
747431|NCT00529763|Primary|Percentage of Participants With Complete, Major, and Overall Hematologic Response (CHR, MaHR, & OHR) in Advanced Disease Chronic Myeloid Leukemia (AD CML) and Blast Phase CML/Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Subjects (Ph+ ALL)|MaHR=CHR or no evidence of leukemia (NEL). CHR=white blood cells (WBC) ≤upper limit of normal (ULN); absolute neutrophil count (ANC) ≥1,000/mm3; platelets ≥100,000/mm3; no blasts/promyelocytes, <20% basophils & <5% myelocytes+metamyelocytes in peripheral blood (PB); BM blasts ≤5%; no extra-medullary involvement/hepatomegaly/splenomegaly. NEL=CHR except platelets ≥20,000/mm3 & <100,000/mm3; ANC >500/mm3 & <1,000/mm3. OHR=CHR+NEL+ return to chronic phase (RTC=<15% blasts in BM and PB; <30% blasts+promyelocytes in BM & PB; <20% basophils in PB; no extra-medullar disease other than spleen & liver)|12 months of follow-up from the start of dasatinib treatment (data cut-off date: 18-Jun-2010)|All treated participants in these cohorts||percentage of participants||95% Confidence Interval|Number
747432|NCT00529763|Primary|Percentage of Chronic Phase Chronic Myeloid Leukemia (CP - CML) Participants With Major Cytogenetic Response (MCyR)|Major Cytogenetic Response (MCyR) is defined as Complete Cytogenetic Response (CCyR: 0% Ph-chromosome-positive cells in metaphase in bone marrow [BM]) or Partial Cytogenetic Response (PCyR: 1-35% Ph-chromosome-positive cells in metaphase in [BM]).|12 months of follow-up from the start of dasatinib treatment (data cut-off date: 18-Jun-2010)|All treated participants in this cohort||percentage of participants||95% Confidence Interval|Number
747433|NCT00529789|Other Pre-specified|Adverse Events Leading to Discontinuation|A listing of adverse events leading to discontinuation from the study. Abbreviation in data table: ADHD = Attention-Deficit/Hyperactivity Disorder.|Week 0 (Baseline) to 30 Weeks|All enrolled patients.||participants|||Number
747434|NCT00529789|Primary|Number of Participants With Potentially Clinically Significant Electrocardiograms at Any Time in Period IV|Total number of patients with any abnormal post-baseline values, based on all values at scheduled and unscheduled visits. Criteria: High QRS Interval = ≥100 milliseconds (msec); High QTc Bazette's or Fredericia's correction - Female = ≥470 msec; High QTc Bazette's or Fredericia's correction - Male = ≥450 msec.|Between 18 and 30 Weeks|Number of patients with baseline (and none abnormal) and post-baseline values, based on all values at scheduled and unscheduled visits.||participants|||Number
747435|NCT00529789|Primary|Number of Participants Meeting Criteria for Potentially Clinically Significant Electrocardiograms at Any Time in Period II/III|Total number of patients with any abnormal post-baseline values, based on all values at scheduled and unscheduled visits. Criteria: High QRS Interval = ≥100 milliseconds (msec); High QTc Bazette's or Fredericia's correction - Female = ≥470 msec; High QTc Bazette's or Fredericia's correction - Male = ≥450 msec.|Baseline to 18 Weeks|Number of patients with baseline (and none abnormal) and post-baseline values, based on all values at scheduled and unscheduled visits.||participants|||Number
747436|NCT00529789|Primary|Number of Participants Meeting Criteria for Potentially Clinically Significant (PCS) Laboratory Analyte Values at Any Time During Period IV|The results shown are for all laboratory analytes where PCS criteria were met, based on criteria used for adult studies. Criteria: High Alkaline Phosphatase (>420 Units/Liter [U/L]); Low Hematocrit (females <0.32; males <0.37); High Inorganic Phosphorus (>1.776 millimoles/L).|Between 18 and 30 Weeks|Total number of patients with baseline (and none abnormal) and post-baseline values in Period IV, based on all values at scheduled and unscheduled visits.||participants|||Number
747437|NCT00529789|Primary|Number of Participants Meeting Criteria for Potentially Clinically Significant (PCS) Laboratory Analyte Values at Any Time During Period II/III|The results shown are for all laboratory analytes where PCS criteria were met, based on criteria used for adult studies. Criteria: High Alanine transaminase (>165 Units/Liter [U/L]); High Creatine Phosphokinase (females: >507 U/L; males:>594 U/L); Low Glucose (<2.498 millimoles/L); Low Hematocrit (females: <0.32; males <0.37); Low Hemoglobin (females <5.896 millimoles/L [mmol/L] iron; males <7.137 mmol/L iron); High Inorganic Phosphorus (>1.776 millimoles/L); Low Leukocyte Count (<2.8 X10^9/L).|Baseline to 18 Weeks|Total number of patients with baseline (and none abnormal) and post-baseline values, based on all values at scheduled and unscheduled visits.||participants|||Number
747449|NCT00530023|Secondary|Blood Glucose Monitoring System - Ratings Questionnaire (BGMS-RQ) Assessed at Baseline and Week 15|Questionnaire measuring overall satisfaction with the relevant blood glucose monitoring system. Assessed at Baseline and Week 15 and compared between arms. Likert scale used with responses graded as the lowest number being the least acceptable and the highest number the most acceptable. The scoring was then transformed to a 0 - 100 scale again with the higher number representing the most acceptable response.|Baseline and 15 weeks|||Scores on a scale||Standard Deviation|Mean
747438|NCT00529789|Primary|Number of Participants Meeting Criteria for Potentially Clinically Significant Vital Sign Values at Any Time During Period IV|Total number of patients with any abnormal post-baseline value, based on all values at scheduled and unscheduled visits. Criteria: High Diastolic Blood Pressure = increase of at least 5 mmHg to a value above the 95th percentile; High Systolic Blood Pressure = increase of at least 5 mmHg to a value above the 95th percentile; High Pulse = increase of at least 25 to a value of at least 110.|Between 18 and 30 Weeks|Number of patients with baseline (and none abnormal) and post-baseline values, based on all values at scheduled and unscheduled visits.||participants|||Number
747439|NCT00529789|Secondary|Change From Baseline to 18 Weeks and 30 Weeks in Children's Depression Rating Scale-Revised (CDRS-R) Total Score|Measures presence and severity of depression. Consists of 17 items scored on a 1-5 or 1-7 scale. A rating of 1 indicates normal, thus the minimum score is 17. The maximum score is 113. In general, scores below 20 indicate an absence of depression; scores of 20 or 30 indicate borderline depression; scores of 40 to 60 indicate moderate depression. Baseline is the same timepoint (Week 0) for both comparisons, but due to differences in number of patients in both periods (II/III vs IV), the baseline values may be slightly different.|Week 0 (Baseline), 18 Weeks, 30 Weeks|18 Week results are for all enrolled patients with a baseline and at least one non-missing post-baseline value; 30 Week results are for the enrolled patients with a baseline and at least one non-missing post-baseline value in Period IV. Last observation carried forward.||units on a scale||Standard Deviation|Mean
747440|NCT00529789|Secondary|Change From Baseline to 18 Weeks and 30 Weeks in Clinical Global Impressions of Severity Scale (CGI-S)|Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Baseline is the same timepoint (Week 0) for both comparisons, but due to differences in number of patients in both periods (II/III vs IV), the baseline values may be slightly different.|Week 0 (Baseline), 18 Weeks, 30 Weeks|18 Week results are for all enrolled patients with a baseline and at least one non-missing post-baseline value; 30 Week results are for the enrolled patients with a baseline and at least one non-missing post-baseline value in Period IV. Last observation carried forward.||units on a scale||Standard Deviation|Mean
747441|NCT00529789|Secondary|Pharmacokinetics: Summary of Observed Duloxetine Plasma Concentrations Stratified by Duloxetine Dose|Plasma samples were obtained at steady state, and approximately 95% of duloxetine concentrations were within the 24 hour dosing interval.|Weeks 2, 4, 6, 8, 10, 14, 18|Number of patients in each duloxetine dose.||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
747442|NCT00529789|Primary|Number of Participants Meeting Criteria for Potentially Clinically Significant Vital Sign Values at Any Time During Period II/III|Total number of patients with any abnormal post-baseline value, based on all values at scheduled and unscheduled visits. Criteria: High Diastolic Blood Pressure = increase of at least 5 mmHg to a value above the 95th percentile; High Systolic Blood Pressure = increase of at least 5 mmHg to a value above the 95th percentile; High Pulse = increase of at least 25 to a value of at least 110.|Baseline to 18 Weeks|Number of patients with baseline (and none abnormal) and post-baseline values, based on all values at scheduled and unscheduled visits.||participants|||Number
747443|NCT00529789|Primary|Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS) During Period IV|The C-SSRS captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. Some questions are yes/no and some are on a scale of 1 (low severity) to 5 (high severity). Completed suicide and non-fatal suicide events are yes/no questions and results presented are the number of participants with these events. Worsening of suicidal ideation was an increase in severity of suicidal ideation from baseline.|Between 18 and 30 Weeks|Number of enrolled patients with baseline and post-baseline values in Period IV.||participants|||Number
747444|NCT00529789|Primary|Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS) During Period II/III|The C-SSRS captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. Some questions are yes/no and some are on a scale of 1 (low severity) to 5 (high severity). Completed suicide and non-fatal suicide events are yes/no questions and results presented are the number of participants with these events. Worsening of suicidal ideation was an increase in severity of suicidal ideation from baseline.|Baseline to 18 Weeks|All enrolled patients.||participants|||Number
747445|NCT00529789|Primary|Number of Participants With Emergence of Suicidal Ideation During Period IV|Emergence of Any Suicidal Ideation: Item 13 of Children's Depression Rating Scale-Revised (CDRS-R) has possible scores of 1 (no thoughts of suicide) to 7 (contemplation of suicide). Emergence of suicidal ideation was defined as an increase in severity of suicidal ideation for those patients who did not have suicidal ideation at baseline (Week 0).|Week 0 and Between 18 and 30 Weeks|All enrolled patients with data for specified category.||participants|||Number
747446|NCT00529789|Primary|Number of Participants With Emergence of Suicidal Ideation During Period II/III|Emergence of Any Suicidal Ideation: Item 13 of Children's Depression Rating Scale-Revised (CDRS-R) has possible scores of 1 (no thoughts of suicide) to 7 (contemplation of suicide). Emergence of suicidal ideation was defined as an increase in severity of suicidal ideation for those patients who did not have suicidal ideation at baseline (Week 0).|Baseline to 18 weeks|All enrolled patients with data for specified category.||participants|||Number
747447|NCT00530023|Secondary|Hypoglycemia Fear Scale (HFS) Assessed at Baseline and Week 15|Questionnaire evaluating change in the subjects' fear of potential hypoglycemia events assessed Week 15 and compared between arms. Likert scale of 0 - 4 used with responses graded as the lowest number being the most acceptable and highest number the least acceptable. The questionnaire has two sections, Behavior and Worry with a maximum possible score of 60 for Behavior (15 X 4) and 72 for Worry (18 X 4). The total combined scoring of these two sections was then assessed at Baseline and Week 15 and the change from Baseline to Week 15 for each arm reported as the end of study result.|Baseline and 15 weeks|||Scores on a scale||Standard Deviation|Mean
747448|NCT00530023|Secondary|Insulin Delivery System - Ratings Questionnaire (IDS-RQ) Assessed at Baseline and Week 15|Questionnaire measuring overall satisfaction with the relevant insulin delivery system. Assessed at Baseline and Week 15 and compared between arms. Likert scale used with responses graded as the lowest number being the least acceptable and the highest number the most acceptable. The scoring was then transformed to a 0 - 100 scale again with the higher number representing the most acceptable response.|Baseline and 15 weeks|||Scores on a scale||Standard Deviation|Mean
747452|NCT00530075|Secondary|SF-36|Assessment of the impact of gusperimus on general health using the Short form-36 (SF-36) questionaire. The SF-36 is a self-report, 36 item survey measuring health-related quality-of-life. Thirty-five items are used to construct 8 scales: (1) physical functioning, (2) role physical, (3) bodily pain, (4) general health, (5) vitality, (6) social function, (7) role emotional, and (8) mental health. Raw scores are calculated as the sum of re-coded scale items and transformed to a 0 to 100 scale. If scores for all 8 scales are available, two summary measures known as component scores are derived: the Physical Health Component Score (PCS) and the Mental Health Component Score (MCS). First each scale standardized to the relevant population. Then PCS and MCS are calculated as the weighted sum of standardized scores. All scales and the component scores are positively scored so that higher scores represent better health-related quality-of-life.|At Entry (Day 1 of Cycle 1), End of treatment period, up to 24 weeks|Efficacy Population||Score on a scale||Full Range|Median
747453|NCT00530075|Secondary|Vasculitis Damage Index (VDI)|Assessment of the degree of irreversible damage due to the vasculitis using VDI scoring system. The VDI comprises 64 items of damage (grouped into 11 organ-based systems). Total VDI score is 0 - 64. The higher scores represent the more severe damage occurred in patients. The VDI score can either increase or remain the same over time.|At Entry (Day 1 of Cycle 1), End of treatment period, up to 24 weeks, 6 months of follow-up period|Efficacy Population||Score on a scale||Full Range|Median
747454|NCT00530075|Secondary|CRP|Assessment of anti-inflammatory activity of gusperimus using surrogate marker: serum C-reactive protein level.|At Entry (Day 1 of Cycle 1), End of treatment period, up to 24 weeks|Patients who had elevated CRP level (> 6 mg/dL) at entry||mg/dL||Full Range|Median
747455|NCT00530075|Secondary|ANCA|"Assessment of anti-neutrophil cytoplasmic antibody (ANCA): Number of ANCA-positive patients was counted.
ANCA are highly associatred with active WG, with c-ANCA titres observed in 90% of WG. In addition to their diagnostic value, it has been suggested that ANCA may have a predictive value for relapse in patients with systemic vasculitis."|At Entry (Day 1 of Cycle 1), End of treatment period, up to 24 weeks|Efficacy Population||Number of participants|||Number
747456|NCT00530075|Secondary|Creatinine|Assessment of anti-inflammatory activity of gusperimus using surrogate marker: serum creatinine level|At Entry (Day 1 of Cycle 1), End of treatment period, up to 24 weeks|Efficacy population||micromol/L||Full Range|Median
747457|NCT00530075|Secondary|Haematuria|Assessment of anti-inflammatory activity of gusperimus using surrogate marker: number of hematuria-positive patients.|At Entry (Day 1 of Cycle 1), End of treatment period, up to 24 weeks|Efficacy population||Number of participants|||Number
747458|NCT00530075|Secondary|Duration of Clinical Response|Time from Complete Remission or Partial Remission to Relapse.|At Entry (Day 1 of Cycle 1), Day 22 of cycles 1-6, up to 24 weeks, End of treatment period, and 3 and 6 months of follow-up period|Patients who had relapsed after achieved at least partial remission||Days||Full Range|Median
747459|NCT00530075|Primary|Remission of Vasculitis|"The primary efficacy outcome measure was remission of vasculitis. Complete remission was defined as a Birmingham vasculitis activity score (BVAS) of 0 sustained for at least 2 months. Partial remission was defined as a reduction in BVAS of 50% or more, sustained for at least 2 months, when compared with the BVAS at entry.
Entry required active Wegener's granulomatosis with a BVAS >= 4. Their disease had to be active, as measured with BVAS in which clinical manifestations caused by active vasculitis are scored on a list of predefined organ-specific items."|At Entry (Day 1 of Cycle 1), Day 22 of cycles 1-6, up to 24 weeks|Efficacy Population||Percentage of participants|||Number
747460|NCT00530088|Primary|Local Toxicity|Number of patients with an adverse event|30 days|All treated and eligible patients||participants|||Number
747461|NCT00530088|Primary|Response|"Response Rate 9.0 TUMOR RESPONSE 9.1 Tumor response will be evaluated at each follow-up visit. 9.2 Objective Tumor Response 9.21 Complete Response - CR1 Complete absence of visible lesion and negative biopsy. CR2 Complete absence of visible lesions without biopsy. 9.22 Partial Response. Reduction in the lesion size by 50% or more in the maximum size of the initial lesion or reduction in grade of lesion, e.g. severe -> mild dysplasia. Patients that have any physical evidence of residual leukoplakia or erythroplasia will require biopsy.
9.23 No Response. All responses less than a Partial Response are considered as No Response.
9.24 Progressive Disease. Any increase in size of the treated lesion or an increase in grade of the treated lesion, i.e. mild to severe dysplasia."|2 years|All treated and eligible patients||percentage of participants||95% Confidence Interval|Number
747462|NCT00530257|Primary|Test of Everyday Attention for Children: Opposite Worlds|The TEA-Ch is a battery of subtests designed to assess multiple attentional capacities in children 6-16y.o. The Opposite Worlds subtest is a measure of attentional control and response inhibition. There is not a finite range of scores on this test. Lower scores indicate better performance..|2 weeks|Crossover design, all 30 of the 31 subjects completed both the placebo and medication phase of the study and were the group analyzed||units on a scale||Full Range|Median
747463|NCT00530257|Primary|Test of Everyday Attention for Children: Sky Search|The TEA-Ch is a battery of nine subtests designed to assess multiple attentional capacities in children 6-16y.o. The Sky Search subtest is a measure of selective attention. There is not a finite range of scores on this subtest, but lower scores indicate better performance.|2 weeks|Crossover design, all 30 of the 31 subjects completed both the placebo and medication phase of the study and were the group analyzed||units on a scale||Full Range|Median
747464|NCT00530257|Primary|Test of Everyday Attention for Children: Map Mission|The TEA-Ch is a battery of nine subtests designed to assess multiple attentional capacities in children 6-16y.o. The Map Mission subtest is a measure of selective attention and indicates the number of targets found in one minute. Scores on this subtest can range from 0 to over 70 with higher scores representing improved performance.|2 weeks|Crossover design, all 30 of the 31 subjects completed both the placebo and medication phase of the study and were the group analyzed||units on a scale||Full Range|Median
747465|NCT00530257|Primary|Test of Everyday Attention for Children: Creature Counting|The TEA-Ch is a battery of nine subtests designed to assess multiple attentional capacities in children 6-16y.o. The Creature Counting subtest is a measure of attentional control. There is not a finite range for this test, but lower scores indicate better performance.|2 weeks|Crossover design, all 30 of the 31 subjects completed both the placebo and medication phase of the study and were the group analyzed||units on a scale||Full Range|Median
747576|NCT00530842|Secondary|Forced Expiratory Volume in 1 Second (FEV1)|Post-dose FEV1 (Forced Expiratory Volume in 1 second) after 4 weeks (measured by spirometry)|4 weeks|FAS using imputed values||Litres||Standard Error|Mean
747466|NCT00530257|Primary|Test of Everyday Attention for Children: Score Dual Task (DT)|The TEA-Ch is a battery of nine subtests designed to assess multiple attentional capacities in children 6-16y.o. The Score DT subtest is a measure of sustained attention. and response inhibition. Scores on this subtest can range from 0 to 20 with higher scores representing better performance.|2 weeks|Crossover design, all 30 of the 31 subjects completed both the placebo and medication phase of the study and were the group analyzed||units on a scale||Full Range|Median
747467|NCT00530257|Primary|Test of Everyday Attention for Children-Sky Search Dual Task|The TEA-Ch is a battery of nine subtests designed to assess multiple attentional capacities in children 6-16y.o. The Sky Search Dual Task is a measure of sustained attention. Lower scores indicate better performance. There is not a finite range for this test and very high scores can be negative numbers.|2 weeks|Crossover design, all 30 of the 31 subjects completed both the placebo and medication phase of the study and were the group analyzed||units on a scale||Full Range|Median
747468|NCT00530257|Other Pre-specified|Stimulant Side Effect Rating Scale|Parents rate 16 possible stimulant side effects on a 10 point likert scale from 0-9 with 0 indicating no side effects and 9 indicating more severe symptoms.|2 weeks|||Units on a scale||Standard Deviation|Mean
747469|NCT00530257|Secondary|ADHD Rating Scale-IV, Parent and Teacher Version|This is the parent and teacher version of the ADHD Rating Scale-IV. The scale has 2 subscales, one for inattention and one for hyperactivity-impulsivity. The scores provided are percentile scores and can range from 1 to 99 percent. Higher scores indicate more problems in inattention or with hyperactivity-impulsivity|2 Weeks|We had complete data for all 30 subjects for the parent rating scale. We only had 24 sets of complete data for the teacher rating scale as some teachers did not return a rating scale when the subject was on both medication and placebo||Percentile||Standard Deviation|Mean
747470|NCT00530257|Secondary|Behavior Rating Inventory of Executive Function||2 Weeks|Although this was included in the protocol we have not analyzed the results of this rating scale||units on a scale||Standard Deviation|Mean
747471|NCT00530257|Primary|Wechsler Intelligence Scale for Children-IV, Digit Span Subtest|The verbal assessment of working memory uses the digit span reversed component of the Digit Span subtest of the Wechsler Intelligence Scale for Children-IV edition (WISC-IV).Scores could range from 0 to 16 with higher scores indicating better performance.|2 weeks|The 30 subjects who completed both arms of the crossover analysis||units on a scale||Full Range|Median
747472|NCT00530257|Primary|Gordon Diagnostic System Continuous Performance Test|This is a measure of sustained attention & response inhibition for children 6 yrs and older. During this task a series of numbers flash, one at a time, on a screen. The subject is told to press a button every time a “1” is followed by a “9”. There are 45 possible correct responses over the 9-minute task. Omission errors are a measure of sustained attention and can range from 0 to 45. Commission errors are a measure of sustained attention and response inhibition can range from zero to hundreds (each time the button is pushed at the incorrect time). Lower scores indicate better performance.|2 weeks|31 participants began the crossover phase of the trial and 30 completed both the medication and placebo arms. For one patient there was an equipment problem so that subject did not have data available||errors||Full Range|Median
747473|NCT00530257|Primary|Test of Everyday Attention for Children: Walk, Don't Walk|The TEA-Ch is a battery of nine subtests designed to assess multiple attentional capacities in children 6-16y.o. The Walk-Don’t Walk subtest is a measure of sustained attention and response inhibition. Scores on this subtest can range from 0 to 20 with higher scores representing better performance.|2 weeks|Crossover design, all 30 of the 31 subjects completed both the placebo and medication phase of the study and were the group analyzed||units on a scale||Full Range|Median
747474|NCT00530270|Secondary|Duration of Hypoxemia (Low Blood Oxygen)|Sum of time periods when subject was hypoxemic (Sp02 value less than 92%) since the first dose date/time|Measured at the end of hospital stay|Subject without major protocol violation and received treatment.||Hours||Standard Deviation|Mean
747475|NCT00530270|Secondary|Duration of Supplemental Oxygen|Time period between the supplemental oxygen start date/time and first dose date/time, whichever is later, and the supplemental oxygen stop date/time|Measured at the end of hospital stay|Subject without major protocol violation and received treatment.||Hours||Standard Deviation|Mean
747476|NCT00530270|Secondary|Duration of Hospitalization|Duration in hours from treatment start time to hospital discharge.|Measured at the end of hospital stay, no maximum number of days|Subject without major protocol violation and received treatment.||Hours||Standard Deviation|Mean
747477|NCT00530270|Secondary|Rating of Pain|Change from baseline rating of pain from randomization (baseline) to discharge from the hospital, evaluated every 4 hours. Pain was rated on the Oucher Scale for the pediatric population or numeric rating scale for the adult population, both 0 to 10 with 0 indicating no pain and 10 indicating severe pain.|Measured at the end of the hospital stay|Subject without major protocol violation and received treatment.||Units on a scale||Standard Error|Mean
747478|NCT00530270|Primary|Log (Natural) of Duration of Signs and Symptoms of Acute Chest Syndrome (ACS) or Duration of Hospitalization, Whichever is Less|Resolution of symptoms of ACS includes respiratory rate <= upper limit of normal +2, no work of breathing (retractions, nasal flaring, and use of accessory muscles), thoracic pain <= 4, no use of supplemental oxygen, no use of ventilary support, and saturation of peripheral oxygen (Sp02) >= steady state value -2. Symptoms were measured every 4 hours from the first dose of study drug to resolution of symptoms or hospital discharge.|Measured from first dose to end of the hospital stay, no maximum number of days|Subject without major protocol violation and received treatment.||hours (log transformed)||Standard Deviation|Log Mean
747479|NCT00530335|Secondary|Cytochrome P450 2D6 (CYP2D6) Phenotype Status|CYP2D6 is the primary atomoxetine metabolizing enzyme. Metabolizer status was determined by focusing on the normal, decreased, and defective allele. Poor metabolizer = defective/defective. Extensive metabolizer is all except for poor metabolizer.|8 weeks|||participants|||Number
747480|NCT00530335|Secondary|Number of Participants With Abnormal QTc Interval Based on International Conference on Harmonisation Criterion|The Fridericia correction of the QT interval(QTcF) was used.|over 8 weeks|All enrolled participants.||participants|||Number
747481|NCT00530335|Secondary|Number of Participants With Potentially Clinically Significant Changes in Body Weight During the Study|Potentially clinically significant weight loss was defined as any decrease of at least 7%. Potentially clinically significant weight gain was defined as any increase of at least 7%.|over 8 weeks|All enrolled participants.||participants|||Number
747483|NCT00530335|Secondary|Change From Endpoint to Baseline in Stroop Color Word Test|An assessment of response inhibition. Three timed tests: reading color words in black ink; reading the printed colored ink; and reading color words printed in different colored ink. There were 100 items for each of the three test categories and if they made it through the 100 words with time remaining, they would repeat the list.|baseline and 8 weeks|All enrolled participants with Last Observation Carried Forward.||number of correct answers||Standard Deviation|Mean
747484|NCT00530335|Secondary|Change From Endpoint to Baseline in 36-item Short-Form Health Survey (SF-36v2) Norm-based Subdomain and Summary Scores|"Derivation of norm-based scoring: Items re-scored to ensure choices were in consistent order and sum up converted score in each subscale; Transform subscale score; Normalize transformed subscale score (i.e. Z-score) using Japanese mean and standard deviation of SF-36v2 subscales.
Calculate: norm-based score=Z-score*10+50 in each subscale."|baseline and 8 weeks|All enrolled participants with Last Observation Carried Forward.||units on a scale||Standard Deviation|Mean
747485|NCT00530335|Secondary|Change From Endpoint to Baseline in Hamilton Anxiety Rating Scale - 14 Items (HAMA) Total Score|The 14-item HAMA assesses the severity of anxiety. The investigator talked to the patient about their symptoms over the previous week before the study visit. Each item was scored using a 5-point scale, i.e. 0 = absent to 4 = severe. The total score of HAMA-14 may range from 0 (normal) to 56 (severe).|baseline and 8 weeks|||units on a scale||Standard Deviation|Mean
747486|NCT00530335|Secondary|Change From Endpoint to Baseline in Hamilton Depression Rating Scale - 17 Items (HAMD-17) Total Score|The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).|baseline and 8 weeks|All enrolled participants with Last Observation Carried Forward.||units on a scale||Standard Deviation|Mean
747487|NCT00530335|Secondary|Change From Endpoint to Baseline in Clinical Global Impression-ADHD - Severity|Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).|baseline and 8 weeks|All enrolled participants with Last Observation Carried Forward.||units on a scale||Standard Deviation|Mean
747488|NCT00530335|Secondary|Change From Endpoint to Baseline in Connors's Adult ADHD Rating Scale-Self Report: Screening Version - Japanese Version (CAARS-S:SV-J)|Scale=30 items divided between 3 subscales: inattention (9 items), hyperactivity-impulsivity (9 items), and ADHD index (12 items), using a 4-point scale (0=not at all/never to 3=very much/very frequently). Total ADHD symptom score consisted of 18 items (sum of inattention and hyperactivity-impulsivity subscales) with range of scores from 0 to 54.|baseline and 8 weeks|All enrolled participants with Last Observation Carried Forward.||units on a scale||Standard Deviation|Mean
747489|NCT00530335|Secondary|Change From Endpoint to Baseline in Connors's Adult ADHD Rating Scale-Investigator Rated: Screening Version - Japanese Version (CAARS-Inv:SV-J)|Scale=30 items divided between 3 subscales: inattention (9 items), hyperactivity-impulsivity (9 items), and ADHD index (12 items), using a 4-point scale (0=not at all/never to 3=very much/very frequently). Total ADHD symptom score consisted of 18 items (sum of inattention and hyperactivity-impulsivity subscales) with range of scores from 0 to 54.|baseline and 8 weeks|All enrolled participants with Last Observation Carried Forward.||units on a scale||Standard Deviation|Mean
747490|NCT00530335|Primary|Number of Participants With Adverse Events Leading to Discontinuation||over 8 weeks|All three participants who discontinued due to an adverse event were on atomoxetine doses of between 80 mg/day and 105 mg/day.||participants|||Number
747491|NCT00530348|Secondary|Percent Change From Baseline in Magnetic Resonance Imaging Time Constant 2 (MRI-T2) Hyperintense Lesion Volume at Year 2|Percent change in MS lesion volume as measured by MRI-T2 scan was calculated from MRI-T2-weighted scans as the following: (lesion volume at 2 years – lesion volume at Baseline)*100/ (lesion volume at Baseline).|Baseline, Year 2|FAS population included all randomized participants who received at least 1 dose of study drug. Here, number of participants analyzed was subset of FAS who had assessment for T2 volume at both Baseline and end-of-study (Year 2).||percent change||Standard Deviation|Mean
747492|NCT00530348|Secondary|Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Score at Year 2|MSFC is a multidimensional measure consisting of quantitative tests of ambulation (Timed 25-Foot Walk), manual dexterity (9-Hole Peg Test; 9HPT), and cognitive function (Paced Auditory Serial Addition Test; PASAT). The MSFC score was calculated as the mean of the Z-scores of the 3 components. A Z-score was calculated by subtracting the mean of the reference population from the test result, then dividing by the standard deviation of the reference population. Higher Z-scores reflected better neurological function and a positive change from Baseline indicates improvement. An increase in score indicated an improvement (Z-score range: -3 to +3). Acquisition of disability was measured by change from Baseline in MSFC score at Year 2.|Baseline, Year 2|FAS population included all randomized participants who received at least 1 dose of study drug. Here, number of participants analyzed signifies subset of FAS who had MSFC score assessment at Baseline; 'n' signifies participants who had MSFC score assessment at Baseline (for Baseline) and at both Baseline and Year 2 (for change at Year 2).||Z-score||Standard Deviation|Mean
747493|NCT00530348|Secondary|Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Year 2|EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses the 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS). Change was calculated by subtracting Baseline value from value at Year 2.|Baseline, Year 2|FAS population included all randomized participants who received at least 1 dose of study drug. Here, number of participants analyzed was subset of FAS who had EDSS assessment at both Baseline and end-of-study (Year 2).||units on a scale||Standard Deviation|Mean
747494|NCT00530348|Secondary|Percentage of Participants Who Were Relapse Free at Year 2|Participants were considered relapse free at Year 2 if they did not experience a relapse from the date of first study treatment to study completion at 24 months. Percentage of participants who were relapse free at Year 2, estimated using the KM method, was reported.|Year 2|FAS population included all randomized participants who received at least 1 dose of study drug.||percentage of participants||95% Confidence Interval|Number
747577|NCT00530842|Secondary|Forced Expiratory Volume in 1 Second (FEV1)|Post-dose FEV1 (Forced Expiratory Volume in 1 second) after 8 weeks (measured by spirometry)|8 weeks|FAS using imputed values||Litres||Standard Error|Mean
747495|NCT00530348|Primary|Annualized Relapse Rate|Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination, attributable to multiple sclerosis that lasted for at least 48 hours, that were present at normal body temperature, and that were preceded by at least 30 days of clinical stability. Annualized relapse rate was estimated through negative binomial regression with robust variance estimation and covariate adjustment for geographic region using observed number of relapses as dependent variable, the log total amount of follow-up from date of first study treatment for each participant as an offset variable, and treatment group and geographic region as model covariates.|Up to 2 years|FAS population included all randomized participants who received at least 1 dose of study drug.||relapses per participant per year||95% Confidence Interval|Number
747496|NCT00530348|Primary|Percentage of Participants With Sustained Accumulation of Disability (SAD)|EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score: 0 (normal neurological examination) to 10 (death due to MS). As measured by EDSS score, SAD was defined as increase of at least 1.5 points for participants with Baseline score of 0 and increase of at least 1.0 point for participants with a Baseline score of 1.0 or more; and the increase persisted for at least next 2 scheduled assessments, that is, 6 consecutive months. Onset date of SAD was date of first EDSS assessment that began 6 month consecutive period of SAD. Participants who did not reach SAD endpoint were censored at their last visit. Percentage of participants with SAD, estimated by Kaplan-Meier (KM) method, was reported.|Up to 2 years|FAS population included all randomized participants who received at least 1 dose of study drug.||percentage of participants with SAD||95% Confidence Interval|Number
747497|NCT00530439|Primary|Gestational Weight Gain|Weight at gestational week 35 - weight by inclusion|Gestational week 35|||kg||Inter-Quartile Range|Median
747498|NCT00530439|Secondary|Metabolic Markers||Until 6 months post partum||||||
747499|NCT00530439|Primary|Neonatal Intensive Care Unit||Within 1 month postpartum||||||
747500|NCT00530439|Primary|Large for Gestational Age||Delivery||||||
747501|NCT00530439|Primary|Gestational Diabetes Mellitus||Delivery||||||
747502|NCT00530439|Primary|Preeclampsia/Pregnancy Induced Hypertension||Delivery||||||
747503|NCT00530439|Primary|Cesarean Section||At delivery||||||
747504|NCT00530504|Primary|Composite Rate of Death, Ipsilateral CVA, Procedure-related CVA, or Myocardial Infarction (MI) at 30 Days Post-procedure.|Combined incidence of Major Adverse Cardiac and Cerebrovascular Events (MACCE) defined as myocardial infarction (MI), ipsilateral cerebrovascular accident (CVA), procedure-related contralateral CVA, or death, within 30 days of implantation.|30 Days|||participants|||Number
747505|NCT00530634|Primary|Two-year Progression-free Survival From the Date of Surgery|Estimated using the product-limit method of Kaplan and Meier. Progression defined as a 25% increase or an increase of 10 cm2 (whichever is smaller) in the sum of the products of all measurable lesions over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline, or clear worsening of any evaluable disease, or reappearance of any lesion that had disappeared, or appearance of any new lesion/site, or failure to return for evaluation or death, or deteriorating condition (unless clearly unrelated to this cancer).|2 years post-surgery|Study was terminated after accruing only three patients.||percentage of participants||95% Confidence Interval|Number
747506|NCT00530712|Secondary|Duplex Ultrasound ≤ 2.4 Primary Patency|Defined as a binary duplex ultrasound ratio ≤ 2.4 at the stented target lesion with no clinically-driven reintervention without the stented segment. Duplex Ultrasound ≤ 2.4 primary patency was evaluated by the Kaplan-Meier method in all enrolled subjects.|1 Year|||Event free percentage||95% Confidence Interval|Number
747507|NCT00530712|Secondary|Walking Improvement||1 Year||||||
747508|NCT00530712|Secondary|Absolute Claudication Distance Improvement|Absolute claudication distance improvement at 1 year was defined as the increase in walking distance determined by a graded treadmill exercise test. Only assessed in subjects enrolled under study procol versions in which the endpoint was predefined.|1 Year|||Miles||Standard Deviation|Mean
747509|NCT00530712|Secondary|Secondary Patency|Secondary patency was defined as PSV ratio < 2.0 maintained by repeat percutaneous intervention after occlusion of the target lesion. Secondary patency was evaluated by the Kaplan-Meier method in all enrolled subjects.|1 Year|||Event free percentage||95% Confidence Interval|Number
747510|NCT00530712|Secondary|Assisted Primary Patency|Assisted primary patency at 1 year was defined as PSV ratio < 2.0 as measured by binary duplex ultrasound maintained by repeated percutaneous intervention completed prior to complete vessel closure. Kaplan-Meier assisted primary patency was evaluated in all enrolled subjects.|1 Year|||Event free percentage||95% Confidence Interval|Number
747511|NCT00530712|Secondary|Increase in Ankle-Brachial Index|Defined as an increase in ancle-brachial index (ABI) at 1 year compared to baseline in subjects with compressible arteries and baseline ABI < 0.9.|1 Year|||Ratio||Standard Deviation|Mean
747512|NCT00530712|Secondary|Improvement in Rutherford Clinical Category|Improvement in Rutherford Clinical Category (RCC) was defined as an improvement in clinical status indicated by a decrease of one or more categories in RCC compared to baseline.|1 Year|||Percentage of participants with data|||Number
747513|NCT00530712|Secondary|Decline in Rutherford Clinical Category|Defined as an increase of one or more categories in RCC compared to baseline.|30 Days||||||
747514|NCT00530712|Secondary|Stent Fracture Rate|Stent integrity determined by x-ray at 1, 2 and 3 years post stent implantation. only 1 year data presented here.|1, 2 and 3 Years|||percentage of stents implanted|Participants||Number
747515|NCT00530712|Secondary|Major Adverse Events|MAE rate at 1 year was defined as clinically-driven TLR, amputation of treated limb, or all-cause mortality that occurs within 1 year post-procedure, as adjudicated by the CEC.|1 Year|||Percentage of particants with data|||Number
747516|NCT00530712|Secondary|Single-Stent Major Adverse Events|MAE rate in subjects who received a single stent was defined as clinically-driven TLR, amputation of treated limb, or all-cause mortality that occurred within 30-days post-procedure, as adjudicated by the CEC. Single stents were implanted in 272 subjects.|30 Days|||Percentage of participants with data|||Number
747578|NCT00530842|Secondary|Forced Expiratory Volume in 1 Second (FEV1)|Trough FEV1 (Forced Expiratory Volume in 1 second) after 4 weeks (measured by spirometry)|4 weeks|FAS using imputed values||Litres||Standard Error|Mean
747517|NCT00530712|Secondary|Single-Stent Primary Patency|Primary stent patency in subjects with single-stent, as determined by the core laboratory, was defined as PSV ratio < 2.0 at the stented target lesion as measured by duplex ultrasound at the 1-year follow-up visit (335-395 days post procedure) and no clinically-driven TLR within the stented segment within 1 year of the procedure. Single stents were implanted in 272 subject.|1 Year|||Percentage of participants with data|||Number
747518|NCT00530712|Primary|Major Adverse Events|Major Adverse Events (MAE) was defined as clinically-driven Target Lesion Revascularization (TLR), amputation of treated limb, or all-cause mortality, as adjudicated by the Clinical Events Commettee (CEC)|30 Days|||Percentage of participants with data|||Number
747519|NCT00530712|Primary|Primary Patency|Primary stent patency, as determined by the core laboratory, was defined as PSV ratio < 2.0 at the stented target lesion as measured by duplex ultrasound at the 1-year follow-up visit (335-395 days post procedure) and no clinically-driven TLR within the stented segment within 1 year of the procedure.|1 Year|||Percentage of participants with data|||Number
747520|NCT00530764|Secondary|Change in Montgomery Asberg Depression Rating Scale (MADRS)|The MADRS comprises of 10 questions that are completed by the patient to determine their depression level. The MADRS was completed at Visit 2 (Baseline) prior to receiving the study drug and at Visit 4 (Week 5 or premature termination). Each item is scored on a 0-6 scale , where 0=no sadness to 6=extreme and continuous gloom and despondency, and the MADRS score is the sum of the 10 item scores (range 0-60). The higher the score the more severe the depression.|Baseline and End of Treatment (Week 5 or premature termination)|||Score on scale||Standard Deviation|Mean
747521|NCT00530764|Secondary|Change in Patient Global Impression of Change - PGIC|A 7-point Likert-type scale was used, with the question: ‘Please assess the status of your pain due to cancer since entry into the study using the scale below’ with the markers “very much improved, much improved, slightly improved, no change, slightly worse, much worse or very much worse”. At Visit 2 (Baseline) patients wrote a brief description of their pain caused by cancer which was used at Week 5 to aid their memory regarding their symptoms at study start. For each of above markers the number of participants were reported.|End of Week 5|||Participants|||Number
747522|NCT00530764|Secondary|Change in Patient Assessment of Constipation Quality of Life (PAC-QoL)|The PAC-QoL questionnaire consists of 28 questions divided into the following areas: 4 questions on physical discomfort, 8 questions on psychosocial discomfort, 11 questions on worries/concerns and 5 questions on satisfaction. The PAC-QoL was completed at baseline and then at the end of treatment. An overall score (range 0-4) was calculated at each visit and the difference determined. A positive difference in score represents an improvement.|Baseline (Visit 2) and End of Treatment (Week 5 or premature termination)|||Score on scale||Standard Deviation|Mean
747523|NCT00530764|Secondary|Change in Brief Pain Inventory – Short Form (BPI-SF)|The BPI-SF is a 14-item questionnaire that asks patients to rate pain over the prior week and the degree to which it interferes with activities on a 0 to 10 scale, where 0=no pain and 10=pain as bad as you can imagine. Severity is measured as worst pain, least pain, average pain, and pain right now. The severity composite score was calculated as the arithmetic mean of the four severity items(range 0-10). the minimum value is zero and maximum is 10. A higher score represents a poor outcome.|Baseline (Visit 2) and End of Treatment (End of Week 5 or premature termination)|||Score on scale||Standard Deviation|Mean
747524|NCT00530764|Secondary|Change in Sleep Disruption NRS|"The sleep disruption NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate how your pain disrupted your sleep last night? where 0 = did not disrupt sleep and 10 = completely disrupted (unable to sleep at all). A negative value indicates an improvement in sleep disruption score from baseline."|5 Weeks: Baseline - End of Treatment (Last 3 days of Week 5)|||Points on scale||Standard Deviation|Mean
747525|NCT00530764|Secondary|Change in Mean Daily NRS Pain Score (Worst Pain).|"The worst pain NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate the number that best describes your worst pain in the last 24 hours where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain due to cancer. A negative value indicates an improvement in worst pain score from baseline."|5 Weeks: Baseline (first 3 days) - End of Treatment (last 3 days of week 5)|||Points on scale||Standard Deviation|Mean
747526|NCT00530764|Secondary|Change in Mean Daily NRS Pain Score (Average Pain).|"The average pain NRS was complete at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain due to cancer. A negative value indicates an improvement in pain score from baseline."|5 Weeks: Baseline (first 3 days) - End of Treatment (last 3 days of week 5)|||Points on scale||Standard Deviation|Mean
747527|NCT00530764|Secondary|Change in Cumulative Average Pain Response Curves|"The cumulative response to treatment is the percentage changes from baseline in the mean NRS pain score as defined as the 30% response.
The pain NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain due to cancer."|Baseline to end of treatment (Week 5)|||Percent Change||Inter-Quartile Range|Median
747528|NCT00530764|Primary|Number of Patients With at Least 30% Improvement in Numerical Rating Scale (NRS) Average Pain Score From Baseline|"A positive 30% pain response is defined as a reduction of at least 30% in the mean NRS average pain score from baseline to week 5 (last 3 days). The patient was asked on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain due to cancer. The average pain NRS was completed at the same time each day, i.e. bedtime in the evening."|5 Weeks: Baseline (first 3 days) - Week 5 (last 3 days)|||Participants|||Number
747529|NCT00530777|Secondary|Vertical HIV-1 Transmission||1 year postpartum|||Participants|||Number
747530|NCT00530777|Primary|Mean Change in HIV-1 Levels in Plasma Between 34 and 38 Weeks Gestation||4 weeks|Women with paired plasma samples at 34 and 38 weeks gestation||log10 copies/mL||Standard Deviation|Mean
747579|NCT00530842|Secondary|Forced Expiratory Volume in 1 Second (FEV1)|Trough FEV1 (Forced Expiratory Volume in 1 second) after 8 weeks (measured by spirometry)|8 weeks|FAS using imputed values||Litres||Standard Error|Mean
747531|NCT00530790|Secondary|Pharmacokinetic Analysis: Plasma Concentrations of SK&F89124, a Circulating Metabolite of Ropinirole.|Plasma samples taken at 24 hours after dosing had been administered for 3 days or longer. This was repeated if the dose was escalated. Lower Limits of Quantitation (LLQ) for SK&89124 = 20 pg/mL. The lowest concentration of analyte can be measured with established acceptable accuracy and precision.|Weeks 1-12|PK Population||picograms/mL||Standard Deviation|Mean
747532|NCT00530790|Secondary|Pharmacokinetic Analysis: Plasma Concentrations of SK&F104557, a Circulating Metabolite of Ropinirole.|Plasma samples taken at 24 hours after dosing had been administered for 3 days or longer. This was repeated if the dose was escalated. Lower Limits of Quantitation (LLQ) for SK&104557 = 20 pg/mL. The lowest concentration of analyte can be measured with established acceptable accuracy and precision.|Weeks 1 -12|PK Population||picograms/mL||Standard Deviation|Mean
747533|NCT00530790|Secondary|Pharmacokinetic Analysis: Plasma Concentrations of SK&F101468, an Unchanged Form of Ropinirole.|Plasma samples taken at 24 hours after dosing had been administered for 3 days or longer. This was repeated if the dose was escalated. Lower Limits of Quantitation (LLQ) for SK&101468 = 20 pg/mL. The lowest concentration of analyte can be measured with established acceptable accuracy and precision.|Weeks 1-12|Pharmacokinetic (PK) Population: subjects who underwent blood sampling for measuring the trough plasma drug concentrations, excluding those who did not fulfill inclusion criteria, those who were considered to affect the evaluation of the PK research due to drug incompliance or other protocol violation.||picograms/mL||Standard Deviation|Mean
747534|NCT00530790|Secondary|Change From Baseline at Week 12/Early Withdrawal (EW) in Hospital Anxiety and Depression Scale (HADS)|"Self screening questionnaire that requires the first response to questions. Questionnaire consists of 14 questions, seven for anxiety 0-21 and seven for depression 0-21. Questions are answered on a four point scale from 0-3; Items 1, 3, 5, 6, 8, 10, 11, and 13 are reversed for summation."|Baseline - Week 12/EW|FAS: Subpopulation: HADS Anxiety population, N = 15; HADS Depression population, N = 31. Patients in the FAS population who also have a baseline anxiety domain score of 8 or greater and patients with a baseline depression domain score of 8 or greater will be included in the HADS Anxiety Population and the HADS Depression Population, respectively.||Points on a scale||Standard Deviation|Mean
747535|NCT00530790|Secondary|Change From Baseline at Week 12/Early Withdrawal (EW) in Profile of Mood Status (POMS)|"The POMS Standard form contains 65 items (0-232). The respondent rates each item on a 5-point scale, ranging from Not at all (0) to Extremely (4). The assessment measures six identified mood factors:
Tension-Anxiety
Depression-Dejection
Anger-Hostility
Vigor-Activity
Fatigue-Inertia
Confusion-Bewilderment"|Baseline and Week 12/EW|Full Analysis Set||Points on a scale||Standard Deviation|Mean
747536|NCT00530790|Primary|Vital Signs and Body Weight Change From Baseline|Units of Measure Vary: Weight = kg; Semi-supine and Standing Systolic and Diastolic BP = mmHg; Semi-supine and Standing Pulse Rate = bpm; EW = early withdrawal; Semi-supine = lying down; Orthostatic = lying, sitting, and standing.|Baseline to Week 12/EW|Safety Population||Varied Standard Units of Measure||Standard Deviation|Mean
747537|NCT00530790|Primary|12-Lead Electrocardiogram (ECG) Findings Transitions From Baseline|Baseline Finding/Time Period Finding. Abbreviations: N = normal; A = abnormal; CS = clinically significant; NCS = not clinically significant. Options include N/N, N/ANCS, N/ACS, ANCS/N, ANCS/ANCS, ANCS/ACS, ACS/N, ACS/ANCS, and ACS/ACS.|Baseline, Week 4, 8, 12, 13 (Follow-up)|Safety Population - (Baseline = 35 subjects, Week 4 = 33 subjects, Week 8 = 31 subjects, Week 12/EW = 33 subjects and Week 13 [Follow-up] = 35 subjects evaluated).||Participants|||Number
747538|NCT00530790|Primary|Urinalysis Clinical Lab Values|Dipstick test values: Neg Value, Trace, +1, +2, +3. No subjects tested higher than +3.|Baseline - Week 13 (Follow-up)|Safety Population (Baseline, Week 4 = 35 subjects, Week 8 = 32 subjects, Week 12 = 30 subjects, Week 12/EW = 33 subjects, Week 13 [Follow-up] = 35 subjects evaluated).||Participants|||Number
747539|NCT00530790|Primary|Blood Chemistry Clinical Lab Values Change From Baseline|Mean Change in Standard Units of Measure: Albumin, Total Protein=G/L; Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Lactate Dehydrogenase, Creatine Phosphokinase, Gamma Glutamyl Transferase=IU/L; Total Bilirubin, Creatinine=UMOL/L; Blood Urea Nitrogen, Cholesterol, Chloride, Sodium, Potassium=MMOL/L; Prolactin=MCG/L|Baseline - Week 13 (Follow-up)|Safety Population (Week 4 = 35 subjects, Week 8 = 32 subjects, Week 12 = 30 subjects, Week 12/EW = 33 subjects, Week 13 (Follow-up) = 35 subjects whose labs were evaluated).||Varied Standard Units of Measure||Standard Deviation|Mean
747540|NCT00530790|Primary|Haematology Clinical Lab Values Change From Baseline|Standard units of measure vary. Therefore, Mean Change is represented in Standard Units: Hematocrit = SI unit of GSK; Hemoglobin = G/L; Platelet count, White Blood Cell count = GI/L; Red Blood Cell count = TI/L. n = number of subjects evaluated. EW = Early Withdrawal.|Baseline - Week 13 (Follow-up)|Safety Population (Week 4 = 35 subjects, Week 8 = 32 subjects, Week 12 = 30 subjects, Week 12/EW = 33 subjects, Week 13 (Follow-up) = 35 subjects whose labs were evaluated).||Varied Standard Units of Measure||Standard Deviation|Mean
747541|NCT00530790|Secondary|Change From Baseline at Week 12/Early Withdrawal (EW) in Johns Hopkins Restless Leg Syndrome Quality of Life Questionnaire (RLSQOL) on the Overall Life Impact Score|The RLSQOL scale consists of 18 items, 13 of which are scored on a 5-point scale. Ten of the items can be summed to the overall life impact score, which can be transformed to a 0-100 score. Mild = 84.48, Moderate = 62.93, or Severe = 37.47|Baseline and Week 12/EW|Full Analysis Set(FAS)||Points on a scale||Standard Deviation|Mean
747542|NCT00530790|Secondary|Change From Baseline to Week 12/EW in Pittsburgh Sleep Quality Index (PSQI) Total Score by Domains|The PSQI generates seven scores that correspond to different domains. Each component score ranges from 0 (no difficulty) to 3 (severe difficulty). The domain scores are totaled to produce a global score (range of 0–21). A PSQI global score > 5 is considered to be suggestive of significant sleep disturbance.|Baseline - Week 12/EW|Full Analysis Set(FAS)||Points on a scale||Standard Deviation|Mean
747543|NCT00530790|Secondary|Change From Baseline at Week 12/Early Withdrawal (EW) in Pittsburgh Sleep Quality Index (PSQI) Total Score|The PSQI generates seven scores that correspond to different domains. Each component score ranges from 0 (no difficulty) to 3 (severe difficulty). The domain scores are totaled to produce a global score (range of 0–21). A PSQI global score > 5 is considered to be suggestive of significant sleep disturbance.|Baseline - Week 12/EW|Full Analysis Set(FAS)||Points on a scale||Standard Deviation|Mean
747580|NCT00530842|Secondary|Slow Vital Capacity (SVC)|Post-dose SVC (Slow Vital Capacity) after 4 weeks (measured by spirometry)|4 weeks|FAS using imputed values||Litres||Standard Error|Mean
747544|NCT00530790|Secondary|Clinical Global Impression Global Improvement (CGI-GI)|CGI-GI is a 7 point scale assessing Global Improvement. 1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6 = Much worse, 7 = Very much worse (no patients scored a 5, 6, or 7).|Baseline - Final assessment point|Full Analysis Set Population (Weeks 1, 2, 3, and 4 = 35 subjects; Weeks 5 and 6 = 33 subjects; Week 8 = 32 subjects; Week 10, 12 = 30 subjects; Final assessment point = 35 subjects). Method for missing date is LOCF.||Participants|||Number
747545|NCT00530790|Secondary|Clinical Global Impression Scale - Severity of Illness (CGI-S)|The CGI-S scale measures the overall severity of illness on a 7 point scale. Normal = 1, Borderline = 2, Mildly = 3, Moderately = 4, Markedly = 5, Severely = 6, Extremely Severe = 7(no subjects scored a 7).|Baseline - Final assessment point|Full Analysis Set Population (Baseline, Weeks 1, 2, 3, 4 = 35 subjects; Weeks 5 and 6 = 33 subjects; Week 8 = 32 subjects; Weeks 10 and 12 = 30 subjects; Final assessment point = 35 subjects). Method of Missing Data = LOCF.||Participants|||Number
747546|NCT00530790|Secondary|Change From Baseline to Week 12 in International Restless Leg Syndrome (IRLS) Rating Scale Total Score|The IRLS Scale assesses the severity of sensory and motor symptoms, sleep disturbance, daytime somnolence, and impact on activities of daily living and mood. The questionnaire scores various questions and totals them using the following scale: Very severe=31-40 points, Severe=21-30 points, Moderate=11-20 points, Mild=1-10 points, None=0 points.|Baseline and after Week 12|Full Analysis Set: Subjects entered to the treatment period, except for those not fulfilling the major registration criteria, those who did not take even one dose of the study medication, and those for whom no observation data were available after starting the study treatment. Method for missing data is Last Observation Carried Forward (LOCF).||Points on a scale||Standard Deviation|Mean
747547|NCT00530790|Primary|Drug Related Adverse Events-On-Therapy||Weeks 1 - 12 Treatment Period|Safety Population consisting of the subjects who took at least one dose of the study medication.||Number of Events|||Number
747548|NCT00530816|Secondary|Overall Survival (OS)|"Overall Survival is defined as the time from the start of study treatment to date of death due to any cause.
Patients who were alive or lost to follow-up as of the data analysis cut-off date for the final OS analysis were censored at the date the patient was last known to be alive. Median OS was estimated using the Kaplan-Meier method."|Patients were followed for up to 2 years after study discontinuation. The data cutoff for the analysis is 19 November 2012 for Part 1 and 07 January 2013 for Part 2. Median follow-up time was 19.1 months for Part 1 and 35.9 months in Part 2.|Safety Population includes all patients enrolled on study and who received at least 1 dose of carfilzomib.||months||95% Confidence Interval|Median
747549|NCT00530816|Secondary|Progression-free Survival (PFS)|"Progression-free Survival (PFS) is defined as the time from start of treatment to IRC determined disease progression or death due to any cause. Patients who were lost to follow-up prior to documentation of disease progression and patients who were alive without disease progression before a data analysis cut-off date were censored at the last disease assessment.
Median PFS was estimated using the Kaplan-Meier method."|Patients were followed for up to 2 years after study discontinuation. The data cutoff for the analysis is 30 November 2010 for Part 1 and 22 April 2011 for Part 2. Median follow-up time was 13.4 months for Part 1 and 11.5 months in Part 2.|Response Evaluable Population||months||95% Confidence Interval|Median
747550|NCT00530816|Secondary|Time to Progression (TTP)|"Time to Progression is defined as the time from the start of treatment to IRC-determined disease progression. Patients who were lost to follow-up prior to documentation of disease progression, or who died before documentation of disease progression or who were alive and did not have documentation of disease progression before the data analysis cut-off date were censored at the last disease assessment.
Median TTP was estimated using the Kaplan-Meier method."|Patients were followed for up to 2 years after study discontinuation. The data cutoff for the analysis is 30 November 2010 for Part 1 and 22 April 2011 for Part 2. Median follow-up time was 13.4 months for Part 1 and 11.5 months in Part 2.|Response Evaluable Population||months||95% Confidence Interval|Median
747551|NCT00530816|Secondary|Duration of Response (DOR)|"DOR is defined as the time from first evidence of PR or better to disease progression assessed by the IRC or death due to any cause. Patients lost to follow-up prior to disease progression or who were alive without disease progression before the analysis cutoff date were censored at the last disease assessment.
Progressive disease was defined as any of the following:
An increase of M-protein in serum (absolute increase ≥ 0.5 g/dL) or urine (absolute increase ≥ 200 mg/24 hours) of > 25% from the nadir (if not zero).
Percentage of plasma cells in bone marrow ≥ 10%.
New or increased size of bone lesions or new plasmacytomas.
Patients without measurable serum and urine M-protein: 25% increase from nadir in the difference between involved and uninvolved FLC levels and absolute increase >10 mg/dL.
Development of hypercalcemia (corrected serum calcium > 11.5 mg/dL) attributed solely to the proliferative disorder.
Median DOR was estimated using Kaplan-Meier methods."|Patients were followed for up to 2 years after study discontinuation. The data cutoff for the analysis is 30 November 2010 for Part 1 and 22 April 2011 for Part 2.|Response Evaluable Population with a response of PR or better.||months||95% Confidence Interval|Median
747552|NCT00530816|Secondary|Clinical Benefit Rate (CBR)|Clinical Benefit Rate is defined as the percentage of participants with a best overall response of minimal response (MR) or better, i.e., a best overall response of sCR, CR, VGPR, PR, or MR. MR was defined as outlined by European Group for Blood and Marrow Transplantation (EBMT) criteria, defined as reduction of M-protein in serum of 25% to 49% and in urine of 50% to 89%, maintained for 6 weeks.|Disease response was assessed on Day 15 of Cycle 1, Day 1 of Cycles 2 through 12, and at End of Study, 30 days after last dose. Median duration of treatment was 100 days for Part 1 and 170 days for Part 2 participants.|Response Evaluable Population||percentage of participants||95% Confidence Interval|Median
747581|NCT00530842|Secondary|Slow Vital Capacity (SVC)|Post-dose SVC (Slow Vital Capacity) after 8 weeks (measured by spirometry)|8 weeks|FAS using imputed values||Litres||Standard Error|Mean
747582|NCT00530842|Secondary|Slow Vital Capacity (SVC)|Trough SVC (Slow Vital Capacity) after 4 weeks (measured by spirometry)|4 weeks|FAS using imputed values||Litres||Standard Error|Mean
747583|NCT00530842|Secondary|Slow Vital Capacity (SVC)|Trough SVC (Slow Vital Capacity) after 8 weeks (measured by spirometry)|8 weeks|FAS using imputed values||Litres||Standard Error|Mean
747584|NCT00530842|Secondary|Static Lung Volumes (Percent)|Post-dose TGV/TLC (Thoracic Gas Volume over Total Lung Capacity) after 4 weeks (measured by bodyphlethysmography)|4 weeks|FAS using imputed values||Percent of TGV over TLC||Standard Error|Mean
747553|NCT00530816|Secondary|Best Overall Response Rate (ORR) in the Response Evaluable Population|"ORR is defined as the percentage of patients who achieved a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR) determined by Independent Review Committee (IRC). Responses were assessed according to International Uniform Response Criteria for Multiple Myeloma, documented by 2 consecutive assessments made at any time before the start of new therapy.
sCR: CR as defined below plus normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.
CR: absence of M-protein in serum and urine by immunofixation, disappearance of any soft tissue plasmacytomas, and ≤5% plasma cells in bone marrow.
VGPR: serum and urine M-proteins detectable by immunofixation but not by electrophoresis or a ≥ 90% reduction in serum M-protein with urine M-protein level < 100 mg/24 hours.
PR: ≥ 50% reduction of serum M-protein and in urine of ≥ 90% or to < 200 mg per 24 hours."|Disease response was assessed on Day 15 of Cycle 1, Day 1 of Cycles 2 through 12, End of Study, 30 days after last dose; median duration of treatment was 100 days for Part 1 and 170 days for Part 2 participants.|The Response Evaluable population consists of all treated patients with measurable disease at Baseline as assessed by M-protein, SFLC or by quantitative serum Ig for certain patients with IgA myeloma, and with a baseline and at least 1 post-baseline disease assessment.||percentage of participants||95% Confidence Interval|Number
747554|NCT00530816|Primary|Best Overall Response Rate (ORR) in the Response Evaluable Subset Population|"ORR is defined as the percentage of patients who achieved a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR) determined by Independent Review Committee (IRC). Responses were assessed according to International Uniform Response Criteria for Multiple Myeloma, documented by 2 consecutive assessments made at any time before the start of new therapy.
sCR: CR as defined below plus normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.
CR: absence of M-protein in serum and urine by immunofixation, disappearance of any soft tissue plasmacytomas, and ≤5% plasma cells in bone marrow.
VGPR: serum and urine M-proteins detectable by immunofixation but not by electrophoresis or a ≥ 90% reduction in serum M-protein with urine M-protein level < 100 mg/24 hours.
PR: ≥ 50% reduction of serum M-protein and in urine of ≥ 90% or to < 200 mg per 24 hours."|Disease response was assessed on Day 15 of Cycle 1, Day 1 of Cycles 2 through 12, and at End of Study, 30 days after last dose. Median duration of treatment was 100 days for Part 1 and 170 days for Part 2 participants.|"The Response Evaluable Subset population consists of all treated patients with measurable disease at Baseline as assessed by M-protein or by quantitative serum Ig for certain patients with IgA myeloma, and with a baseline and at least 1 post-baseline disease assessment.
Patients whose disease was only measurable by SFLC were excluded."||percentage of participants||95% Confidence Interval|Number
747555|NCT00530842|Secondary|Locus of Symptom Limitation at Peak Exercise During Exercise|Reason for stopping exercise after 8 weeks (leg discomfort, breathing discomfort, both or none)|8 weeks|FAS using imputed values||Participants|||Number
747556|NCT00530842|Secondary|Locus of Symptom Limitation at Peak Exercise During Exercise|Reason for stopping exercise after 4 weeks (leg discomfort, breathing discomfort, both or none)|4 weeks|FAS using imputed values||Participants|||Number
747557|NCT00530842|Secondary|Locus of Symptom Limitation at Peak Exercise During Exercise|Reason for stopping exercise at baseline (leg discomfort, breathing discomfort, both or none)|baseline|FAS using imputed values||Participants|||Number
747558|NCT00530842|Secondary|Dyspnea and Leg Discomfort|Peak Borg leg discomfort scale after 8 weeks, Unit on a Scale (min. 0, max 10)|8 weeks|FAS using imputed values||Unit on a Scale||Standard Deviation|Mean
747559|NCT00530842|Secondary|Dyspnea and Leg Discomfort|Peak Borg dyspnea scale after 8 weeks, Unit on a Scale (min. 0, max 10)|8 weeks|FAS using imputed values||Unit on a Scale||Standard Deviation|Mean
747560|NCT00530842|Secondary|Symptom Intensity During Exercise|Isotime Borg leg discomfort scale after 4 weeks, Unit on a Scale (min. 0, max. 10), 0 = no leg dyscomfort, 10 = worst imaginable leg dyscomfort|4 weeks|FAS using imputed values||Unit on a Scale||Standard Error|Mean
747561|NCT00530842|Secondary|Symptom Intensity During Exercise|Isotime Borg leg discomfort scale after 8 weeks, Unit on a Scale (min. 0, max. 10), 0 = no leg dyscomfort, 10 = worst imaginable leg dyscomfort|8 weeks|FAS using imputed values||Unit on a Scale||Standard Error|Mean
747562|NCT00530842|Secondary|Symptom Intensity During Exercise|Isotime Borg dyspnea scale after 4 weeks, Unit on a Scale (min. 0, max. 10), 0 = no dyspnea, 10 = worst imaginable dyspnea|4 weeks|FAS using imputed values||Unit on a Scale||Standard Error|Mean
747563|NCT00530842|Secondary|Symptom Intensity During Exercise|Isotime Borg dyspnea scale after 8 weeks, Unit on a Scale (min. 0, max 10), 0 = no dyspnea, 10 = worst imaginable dyspnea|8 weeks|FAS using imputed values||Unit on a Scale||Standard Error|Mean
747564|NCT00530842|Secondary|FEV1 Over FVC (Percent)|Post-dose FEV1 (Forced Expiratory Volume in 1 second) over FVC (Forced Vital Capacity) after 4 weeks (measured by spirometry)|4 weeks|FAS using imputed values||Percent of FEV1 over FVC||Standard Error|Mean
747565|NCT00530842|Secondary|FEV1 Over FVC (Percent)|Post-dose FEV1 (Forced Expiratory Volume in 1 second) over FVC (Forced Vital Capacity) after 8 weeks (measured by spirometry)|8 weeks|FAS using imputed values||Percent of FEV1 over FVC||Standard Error|Mean
747566|NCT00530842|Secondary|FEV1 Over FVC (Percent)|Trough FEV1 (Forced Expiratory Volume in 1 second) over FVC (Forced Vital Capacity) after 4 weeks (measured by spirometry)|4 weeks|FAS using imputed values||Percent of FEV1 over FVC||Standard Error|Mean
747567|NCT00530842|Secondary|FEV1 Over FVC (Percent)|Trough FEV1 (Forced Expiratory Volume in 1 second) over FVC (Forced Vital Capacity) after 8 weeks (measured by spirometry)|8 weeks|FAS using imputed values||Percent of FEV1 over FVC||Standard Error|Mean
747568|NCT00530842|Secondary|Forced Vital Capacity (FVC)|Post-dose FVC (Forced Vital Capacity) after 4 weeks (measured by spirometry)|4 weeks|FAS using imputed values||Litres||Standard Error|Mean
747569|NCT00530842|Secondary|Forced Vital Capacity (FVC)|Post-dose FVC (Forced Vital Capacity) after 8 weeks (measured by spirometry)|8 weeks|FAS using imputed values||Litres||Standard Error|Mean
747570|NCT00530842|Secondary|Forced Vital Capacity (FVC)|Trough FVC (Forced Vital Capacity) after 4 weeks (measured by spirometry)|4 weeks|FAS using imputed values||Litres||Standard Error|Mean
747571|NCT00530842|Secondary|Forced Vital Capacity (FVC)|Trough FVC (Forced Vital Capacity) after 8 weeks (measured by spirometry)|8 weeks|FAS using imputed values||Litres||Standard Error|Mean
747597|NCT00530842|Secondary|Static Lung Volumes|Post-dose IRV (Inspiratory Reserve Volume) after 8 weeks (measured by bodyphlethysmography)|8 weeks|FAS using imputed values||Litres||Standard Error|Mean
747610|NCT00530842|Secondary|Endurance Time (After 4 Weeks)|Endurance time to the point of symptom limitation after 4 weeks during a constant work rate exercise test at 75% Wcap (co-primary endpoint)|4 weeks|FAS using imputed values||Seconds||Inter-Quartile Range|Median
747611|NCT00530842|Secondary|Post-dose TGV(FRC) (After 4 Weeks)|Post-dose TGV(FRC) (Thoracic Gas Volume) after 4 weeks|4 weeks|FAS using imputed values||Litres||Standard Error|Mean
747612|NCT00530842|Primary|Endurance Time (After 8 Weeks)|Endurance time to the point of symptom limitation after 8 weeks during a constant work rate exercise test at 75% Wcap (co-primary endpoint)|8 weeks|FAS using imputed values||Seconds||Inter-Quartile Range|Median
747613|NCT00530842|Primary|Post-dose TGV(FRC) (After 8 Weeks)|Post-dose TGV(FRC) (Thoracic Gas Volume; co-primary endpoint) after 8 weeks|8 weeks|FAS using imputed values. The full analysis set (FAS) was defined to include all treated patients with any post-dosing efficacy data after at least 4 weeks for both investigational treatments in TGV(FRC) or endurance time.||Litres||Standard Error|Mean
747614|NCT00530855|Secondary|Occurrence of Treatment-Emergent Adverse Events (TEAE) Leading to Subject Withdrawal From Visit 1 to End of Study||From Visit 1 to End of Study (approximately 2 years)|All 322 Subjects from the Safety Set are included in the Analysis of this Outcome Measure. Safety Set is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.||Participants|||Number
747615|NCT00530855|Secondary|Occurrence of At Least One Treatment-Emergent Adverse Event (TEAE) From Visit 1 to End of Study|"A TEAE is defined as any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any phase of a clinical trial including Pretreatment, Run-In, Wash-Out, or Follow-Up Phases.
An TEAE is defined as being independent of assumption of any causality (eg, to trial or concomitant medication, primary or concomitant disease, or trial design)."|From Visit 1 to End of Study (approximately 2 years)|All 322 Subjects from the Safety Set are included in the Analysis of this Outcome Measure. Safety Set is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.||Participants|||Number
747616|NCT00530855|Primary|Duration of Lacosamide (LCM) Monotherapy Treatment From Visit 1 to End of Study|Duration of total Lacosamide Monotherapy From Visit 1 to End of Study.|From Visit 1 to End of Study (approximately 2 years)|All 322 Subjects from the Safety Set are included in the Analysis of this Outcome Measure. Safety Set is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.||days||Standard Deviation|Mean
747617|NCT00530855|Primary|Percentage of Subjects on Lacosamide (LCM) Monotherapy at Any Time Between Visit 1 and End of Study|Percentage of Subjects on Lacosamide (LCM) Monotherapy at any time between Visit 1 and End of Study.|From Visit 1 to End of Study (approximately 2 years)|All 322 Subjects from the Safety Set are included in the Analysis of this Outcome Measure. Safety Set is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.||Participants|||Number
747618|NCT00530894|Secondary|Change in Quality of Life (QOL) From Baseline to 1 Year|"The QOL questionnaire consisted of: Kansas City Cardiomyopathy (KCCQ), The Medical Outcomes Study Short-Form 12 (SF-12) - physical and metal states.
KCCQ scores are on a range of 0-100, in which 100 reflects the best health status and 0 reflects the worst health status.
SF-12 questionnaire was used in which 100 reflects the best health status and 0 reflects the worst health status."|Baseline and 1 Year|Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.||Units on a scale||Standard Deviation|Mean
747619|NCT00530894|Secondary|Total Hospital Days From the Index Procedure|Total hospital days from the index procedure or randomization into control arm to one year post procedure or randomization.|1 year|||Days||Standard Deviation|Mean
747620|NCT00530894|Secondary|Number of Participants With Major Adverse Cardiac and Cerebro-vascular Events (MACCE)|Number of participants with MACCE definition includes death, myocardial infarction (MI), stroke and renal failure|1 year|||participants|||Number
747621|NCT00530894|Secondary|Functional Change of NYHA|NYHA classification change from baseline to 1 year visit. NYHA provides a way of classifying the extent of heart failure. New York Heart Association (NYHA) is a functional classification of heart failure based on how much a patient is limited during physical activity. The rating ranges from I - IV, with the lowest (I) as no limitations and the highest (IV) unable to carry on any physical activity without discomfort.|Baseline to 1 year|Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.||Units on scale||95% Confidence Interval|Least Squares Mean
747622|NCT00530894|Primary|Composite of Death and Recurrence Hospitalization.|Death from any cause or repeat hospitalization after intervention.|duration of study|Composite of Death and recurrence hospitalization was not a primary outcome for the High Risk groups.||participants|||Number
747623|NCT00530894|Primary|Death|Death from any cause.|1 Year|||participants|||Number
747624|NCT00530920|Secondary|Clinical Abnormal Findings in Laboratory and Physical Examination||Screening through the end of the study (14 days)|Treated set.||participants|||Number
747625|NCT00530920|Secondary|Cmax of Ritonavir|Ritonavir pharmacokinetics|Visits baseline, 5, 7, 9 and 13 or 14|Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment||uM||Geometric Coefficient of Variation|Geometric Mean
747626|NCT00530920|Secondary|Tmax of Ritonavir|Ritonavir pharmacokinetics|Final (Day 14)|Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment||h||Geometric Coefficient of Variation|Geometric Mean
747627|NCT00530920|Secondary|Terminal Half-Life (t1/2) of Ritonavir|Ritonavir pharmacokinetics|Final (Day 14)|Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment||Hours||Geometric Coefficient of Variation|Geometric Mean
747628|NCT00530920|Secondary|Volume of Distribution (V/F) of Ritonavir|Ritonavir pharmacokinetics|Final (Day 14)|Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment||L||Geometric Coefficient of Variation|Geometric Mean
747629|NCT00530920|Secondary|Apparent Oral Clearance I(Cl/F) of Ritonavir|Ritonavir pharmacokinetics|Final (Day 13 for QD, Day 14 for BID)|Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment||L/h||Geometric Coefficient of Variation|Geometric Mean
747630|NCT00530920|Secondary|Cp 24 h of Ritonavir for QD and CP 12 h of Ritonavir for BID|Ritonavir pharmacokinetics|Final (Day 13 for QD, Day 14 for BID)|Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment||uM||Geometric Coefficient of Variation|Geometric Mean
747631|NCT00530920|Secondary|AUC 24 of Ritonavir for QD and AUC 12 of Ritonavir for BID|Ritonavir pharmacokinetics|Final (Day 13 for QD, Day 14 for BID)|Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment||h*uM||Geometric Coefficient of Variation|Geometric Mean
747632|NCT00530920|Secondary|Time to Cmax (Tmax) of Tipranavir|Tipranavir pharmacokinetics|Final (Day 14)|Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment||h||Geometric Coefficient of Variation|Geometric Mean
747633|NCT00530920|Secondary|Terminal Half-Life (t1/2) of Tipranavir|Tipranavir pharmacokinetics|Final (Day 14)|Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment||h||Geometric Coefficient of Variation|Geometric Mean
747634|NCT00530920|Secondary|Volume of Distribution (V/F) of Tipranavir|Tipranavir pharmacokinetics|Final (Day 14)|Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment||L||Geometric Coefficient of Variation|Geometric Mean
747635|NCT00530920|Secondary|Maximum Concentration (Cmax) of Tipranavir|TPV pharmacokinetics|Final (Day 13 for QD, Day 14 for BID)|Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment||uM||Geometric Coefficient of Variation|Geometric Mean
747636|NCT00530920|Secondary|Trough Concentration (Cmin) of Tipranavir|TPV pharmacokinetics|Final (Day 13 for QD, Day 14 for BID)|Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment||uM||Geometric Coefficient of Variation|Geometric Mean
747637|NCT00530920|Secondary|Concentration-24 Hour (hr) Post Dose of Tipranavir - (Cp 24 h for QD and 12 hr Post Dose (CP 12h) for BID|TPV pharmacokinetics|Final (Day 13 for QD, Day 14 for BID)|Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment||uM||Geometric Coefficient of Variation|Geometric Mean
747638|NCT00530920|Secondary|Area Under the Curve(AUC) of Tipranavir 24 h for Once Daily (QD) and AUC 12 h for Twice Daily (BID)|Tipranavir (TPV) pharmacokinetics|Final (Day 13 for QD, Day 14 for BID)|Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment||h*uM||Geometric Coefficient of Variation|Geometric Mean
747639|NCT00530920|Secondary|Apparent Oral Clearance I(Cl/F) of Tipranavir|"Tipranavir pharmacokinetics - Clearance (CL) is defined as the dose of a drug divided by the area-under-the-concentration-time curve (AUC), ie. CL = Dose / AUC. For extravascu­lar models the fraction of dose absorbed cannot be estimated, therefore clear­ance for these models is actually Cl/F where F is the fraction of the drug dose which is absorbed."|Final (Day 14)|Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment||L/h||Geometric Coefficient of Variation|Geometric Mean
747640|NCT00530920|Primary|Viral Load (log10 Copies/mL) Change From Baseline (Last Observation Carried Forward (LOCF))||Baseline (Day 0) to Final (Day 14)|Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment||Log10 copies/mL||Inter-Quartile Range|Median
747641|NCT00530946|Secondary|Change in Apolipoprotein B From Baseline to Each Observation Point|Value at Week 2, Week 4, or Week 8 minus value at baseline|2 weeks, 4 weeks, and 8 weeks|Full Analysis Set, Observed Cases||mg/dL||Standard Deviation|Mean
747642|NCT00530946|Secondary|Change in Total Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (TC/HDL-C) From Baseline to Each Observation Point|Value at Week 2, Week 4, or Week 8 minus value at baseline|2 weeks, 4 weeks , and 8 weeks|Full Analysis Set, Observed Cases||Ratio||Standard Deviation|Mean
747643|NCT00530946|Secondary|Change in Low Density Lipoprotein-Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (LDL-C/HDL-C) From Baseline to Each Observation Point|Value at Week 2, Week 4, or Week 8 minus value at baseline|2 weeks, 4 weeks, and 8 weeks|Full Analysis Set, Observed Cases||Ratio||Standard Deviation|Mean
747644|NCT00530946|Secondary|Percent Change in Triglycerides From Baseline to Each Observation Point|"Percent of value at Week 2, Week 4, or Week 8 minus value at baseline over value at baseline"|2 weeks, 4 weeks , and 8 weeks|Full Analysis Set, Observed Cases||Percent Change||Standard Deviation|Mean
747645|NCT00530946|Secondary|Percent Change in High Density Lipoprotein-Cholesterol From Baseline to Each Observation Point|"Percent of value at Week 2, Week 4, or Week 8 minus value at baseline over value at baseline"|2 weeks, 4 weeks , and 8 weeks|Full Analysis Set, Observed Cases||Percent Change||Standard Deviation|Mean
747646|NCT00530946|Secondary|Percent Change in Total Cholesterol From Baseline to Each Observation Point|"Percent of value at Week 2, Week 4, or Week 8 minus value at baseline over value at baseline"|2 weeks, 4 weeks , and 8 weeks|Full Analysis Set, Observed Cases||Percent Change||Standard Deviation|Mean
747647|NCT00530946|Secondary|Percent Change in Low Density Lipoprotein-Cholesterol From Baseline to Each Observation Point|"Percent of value at Week 2, Week 4, or Week 8 minus value at baseline over value at baseline"|2 weeks, 4 weeks , and 8 weeks|Full Analysis Set, Observed Cases||Percent Change||Standard Deviation|Mean
747648|NCT00530946|Secondary|Change in Diastolic Blood Pressure From Baseline to Each Observation Point|Value at Week 2, Week 4, or Week 8 minus value at baseline|2 weeks, 4 weeks , and 8 weeks|Full Analysis Set, Observed Cases||mm Hg||Standard Deviation|Mean
747649|NCT00530946|Secondary|Change in Systolic Blood Pressure From Baseline to Each Observation Point|Value at Week 2, Week 4, or Week 8 minus value at baseline|2 weeks, 4 weeks, and 8 weeks|Full Analysis Set, Observed Cases||mm Hg||Standard Deviation|Mean
747650|NCT00530946|Primary|Percent Change in Low Density Lipoprotein-Cholesterol|"Percent of value at Week 8 minus value at baseline over value at baseline"|8 weeks|Full Analysis Set, Last Observation Carried Forward||Percent Change||Standard Error|Least Squares Mean
747651|NCT00530946|Primary|Change in Systolic Blood Pressure|Value at Week 8 minus value at baseline|8 weeks|Full Analysis Set, Last Observation Carried Forward||mm Hg||Standard Error|Least Squares Mean
747900|NCT00525512|Secondary|Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 80 Weeks - Double-Blind Phase|FEV1 is the maximal amount of air you can forcefully exhale in one second.|baseline, 80 weeks|||liters||Standard Error|Least Squares Mean
747652|NCT00531011|Primary|In-stent Late Loss (LL)|Full Analysis Set (FAS). LL is defined as the difference between the post-procedure (immediately post placement of the stent) minimal lumen diameter (MLD) and the follow-up MLD (at 270 days). In stent is measured within the confines of the stent edges.|at 270 days|Descriptive statistics for this measure are based on one random lesion per patient, 167 patients performed angiographic follow-up.||millimeters|Participants|Standard Deviation|Mean
747653|NCT00531011|Secondary|Distal Minimum Lumen Diameter (MLD).|Distal refers to the immediate 5 mm outside of the distal end of the stent.|at 9 months.|||millimeters|Participants|Standard Deviation|Mean
747654|NCT00531011|Secondary|Proximal Minimum Lumen Diameter (MLD).|Proximal refers to the immediate 5 mm outside of the proximal end of the stent.|at 9 months.|||millimeters|Participants|Standard Deviation|Mean
747655|NCT00531011|Secondary|In-segment Minimum Lumen Diameter (MLD).||at 9 months.|||millimeters|Participants|Standard Deviation|Mean
747656|NCT00531011|Secondary|In-stent Minimum Lumen Diameter (MLD).||at 9 months.|||millimeters|Participants|Standard Deviation|Mean
747657|NCT00531011|Secondary|Composite Endpoint of All Death, MI (Q-wave and Non Q-wave), and TVR.||9 months|ITT||percentage of participants|||Number
747658|NCT00531011|Secondary|Composite Endpoint of Cardiac Death, MI (Q-wave and Non Q-wave), and Ischemia-driven TLR .|ITT|9 months|ITT||percentage of participants|||Number
747659|NCT00531011|Secondary|Revascularizations|(TLR/TVR/any revascularization)both ischemia-driven and not ischemia-driven.|9 months|ITT||percentage of participants|||Number
747660|NCT00531011|Secondary|Revascularizations|(TLR/TVR/any revascularization)both ischemia-driven and not ischemia-driven.|at 30 days|ITT||percentage of participants|||Number
747661|NCT00531011|Secondary|Adjudicated Stent Thrombosis.||9 months|ITT||percentage of participants|||Number
747662|NCT00531011|Secondary|Adjudicated Stent Thrombosis.||at 30 days|||percentage of participants|||Number
747663|NCT00531011|Secondary|Device Success|defined as achievement of a final residual in-stent diameter stenosis of < 30% (visual assessment) using the assigned device only.|at the time of PCI|||percentage of participants|Participants||Number
747664|NCT00531011|Secondary|Procedural Success|defined as: residual in-stent %DS of < 30% using a percutaneous method, without cardiac death, Q-wave MI, non Q-wave MI, or repeat revasc of the target during hospitalization.|at the time of PCI|||percentage of participants|Participants||Number
747665|NCT00531011|Secondary|Lesion Success|defined as attainment of < 30% residual in-stent stenosis (by visual assessment) using any percutaneous method.|at the time of PCI|Intent to treat (ITT)||Percentage of participants|Participants||Number
747666|NCT00531011|Secondary|Composite Rate of All Death, MI (Q-wave and Non Q-wave), and Target Vessel Revascularization (TVR).||at 30 days|ITT||percentage of participants|||Number
747667|NCT00531011|Secondary|Composite Rate of Cardiac Death, Myocardial Infarction (MI, Both Q-wave and Non Q-wave), and Ischemia-driven Target Lesion Revascularization (TLR) .|This measure is a calculation of the percentage of participants who experience any of the components of this composite measure.|at 30 days|ITT||percentage of participants|||Number
747668|NCT00531011|Secondary|In-segment Late Loss (LL)|LL is defined as the difference between the post-procedure (immediately post placement of the stent) minimal lumen diameter (MLD) and the follow-up MLD (at 270 days). In segment LL is measured within the confines of the stent edges and within 5 mm of those edges.|at 9 months|167 patients performed angiographic follow-up. Descriptive statistics for this measure are based on one random lesion per patient.||millimeters|Participants|Standard Deviation|Mean
747669|NCT00531011|Secondary|In-segment Binary Restenosis Rate|"This measures the percentage of patients who have > 50% diameter stenosis of the assessed vessel, within the stent edges
In-segment is measured within the confines of the stent edges plus within 5 mm on either side of the stent."|at 9 months|167 patients performed angiographic follow-up.||percentage of participants|Participants||Number
747670|NCT00531011|Secondary|In-stent Binary Restenosis Rate|This measures the percentage of patients who have > 50% diameter stenosis of the assessed vessel, within the stent edges.|at 9 months|ITT, 167 patients performed angiographic follow-up.||percentage of participants|Participants||Number
747671|NCT00531050|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) During Part 1 and Part 2|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the mean of the 23 hours 30 minutes and 24 hours post morning dose FEV1 measurements. Analysis of covariance included pre-dose FEV1 as covariate.|23 hours 30 minutes and 24 hours post-dose at Day 1|The safety population consisted of all subjects who received at least one dose of study medication after randomization.||Liters||95% Confidence Interval|Least Squares Mean
747672|NCT00531050|Primary|Maximum Heart Rate (HR) During Salbutamol Administration in Part 2|Maximum HR (0-12 hours): maximum (max) of post dose measurement up to second administration. Maximum HR (12-24 hours): max of the post second administration of salbutamol measurements. Maximum HR (0-24 hours): max of all post dose measurements up to and including the 24 hour measurement. Mixed effects analysis model used period baseline HR as the covariate. The maximum HR for 0-24 hours (h) is the maximum of the maximum HR for the two 12h periods and thus the average (LS means) of the maximum HRs for 0-24h will be equal to or greater than the average of the maximum for the two periods.|24 hours post dose on Day 1|The safety population consisted of all subjects who received at least one dose of study medication after randomization. ECG monitoring was not performed successfully for three subjects in Part 2 during the afternoon monitoring. These subjects were therefore excluded from the analysis of heart rate.||Beats per minute (bpm)||95% Confidence Interval|Least Squares Mean
747673|NCT00531050|Primary|Maximum Heart Rate During Exercise in Part 1|Maximum heart rate was generally taken from the continuous ECG monitoring. Analysis based on mixed effects analysis using model with treatment and period as fixed effects and subject as random effect.|2 hour post-dose on Day 1|The safety population consisted of all subjects who received at least one dose of study medication after randomization.||Beats per minute (bpm)||95% Confidence Interval|Least Squares Mean
747699|NCT00531284|Secondary|Volume of Distribution at Steady State (Vss) of Carfilzomib||Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.|Safety population with available pharmacokinetic (PK) data. PK analyses were conducted in solid tumor and multiple myeloma groups only and were not conducted for lymphoma or participants enrolled under Amendment 4 (CFX + dexamethasone).||liters||Standard Deviation|Mean
747674|NCT00531050|Primary|Percentage of Participants With Maximum Heart Rate Increase During Salbutamol Administration in Part 2 of the Study|"The percentage of patients with an increase of >= 10 beats per minute (bpm) in their heart rate (HR) following treatment with indacaterol and salmeterol compared to treatment with placebo over 24 hours in Part 2 was determined.
0-12 hours: post first dose measurements up to second dose
12-24 hours: post second dose measurement up to and including the 24 hour measurement
0-24 hours: all post dose measurements up to and including the 24 hour measurement"|24 hours post dose on Day 1|Safety population. ECG monitoring was not performed successfully for three subjects in Part 2 during the afternoon monitoring. These subjects were therefore excluded from the analysis of heart rate. In a patient where data for the second 12 hour period is missing, 0-24 is not reported; hence the discrepancy of 4 and 3 subjects.||Percentage of participants||95% Confidence Interval|Number
747675|NCT00531050|Secondary|Change in Heart Rate During Exercise in Part 1|"Change in heart rate is calculated from the 1.5 hour post dose to the maximum heart rate during exercise.
Analysis of covariance included treatment and period as fixed effects, subject as random effect and 1.5 hour pre-exercise/post dose heart rate as a covariate."|1.5 hour post dose to max heart rate during exercise|The safety population consisted of all subjects who received at least one dose of study medication after randomization.||Beats per minute (bpm)||95% Confidence Interval|Least Squares Mean
747676|NCT00531050|Primary|Percentage of Participants With Maximum Heart Rate Increase During Exercise in Part 1 of the Study|The percentage of patients with an increase of more than 10 beats per minute (bpm) in their heart rate following treatment with indacaterol and salmeterol compared to treatment with placebo was determined.|24-hours post-dose on Day 1 (of each treatment)|The safety population consisted of all subjects who received at least one dose of study medication after randomization.||Percentage of participants||95% Confidence Interval|Number
747677|NCT00531206|Secondary|Alkaline Phosphatase Over Time||52 weeks|Full Analysis Set (FAS), all patients entered and treated||international units/liter||Inter-Quartile Range|Median
747678|NCT00531206|Secondary|Total Bilirubin Over Time||52 weeks|Full Analysis Set (FAS), all patients entered and treated||mg/dl||Inter-Quartile Range|Median
747679|NCT00531206|Secondary|Creatinine Over Time||52 weeks|Full Analysis Set (FAS), all patients entered and treated||mg/dl||Inter-Quartile Range|Median
747680|NCT00531206|Secondary|Gamma-glutamyl Transpeptidase (GGT) Over Time||52 weeks|Full Analysis Set (FAS), all patients entered and treated||international units/liter||Inter-Quartile Range|Median
747681|NCT00531206|Secondary|Aspartate Aminotransferase (ALT) Over Time||52 weeks|Full Analysis Set (FAS), all patients entered and treated||international units/liter||Inter-Quartile Range|Median
747682|NCT00531206|Secondary|Alanine Aminotransferase (ALT) Over Time||52 weeks|Full Analysis Set (FAS), all patients entered and treated||international units/liter||Inter-Quartile Range|Median
747683|NCT00531206|Secondary|Triglycerides Over Time||52 weeks|Full Analysis Set (FAS), all patients entered and treated||mg/dl||Inter-Quartile Range|Median
747684|NCT00531206|Secondary|Low Density Lipoprotein (HDL) Cholesterol Over Time||52 weeks|Full Analysis Set (FAS), all patients entered and treated||mg/dl||Inter-Quartile Range|Median
747685|NCT00531206|Secondary|High Density Lipoprotein (HDL) Cholesterol Over Time||52 weeks|Full Analysis Set (FAS), all patients entered and treated||mg/dl||Inter-Quartile Range|Median
747686|NCT00531206|Secondary|Total Cholesterol Over Time||52 weeks|Full Analysis Set (FAS), all patients entered and treated||mg/dl||Inter-Quartile Range|Median
747687|NCT00531206|Secondary|Body Mass Index Class (Kilograms/Square Meter)||52 weeks|Full Analysis Set (FAS), all patients entered and treated||participants|||Number
747688|NCT00531206|Secondary|Use of Lipid Lowering Agents During the Study||52 weeks|Full Analysis Set (FAS), all patients entered and treated||participants|||Number
747689|NCT00531206|Secondary|Number of Anti-retroviral Medications Taken in Combination With Tipranavir/Ritonavir||52 weeks|Full Analysis Set (FAS), all patients entered and treated||participants|||Number
747690|NCT00531206|Secondary|Adverse Events Related to Therapy With Tipranavir/Ritonavir Based on Investigator's Opinion|The safety and tolerability of the observed antiretroviral therapy were based on the Adverse Events (AEs) and Serious Adverse Events (SAEs) reported in the case report forms.|52 weeks|Full Analysis Set (FAS), all patients entered and treated||Number of patients|||Number
747691|NCT00531206|Secondary|Discontinuations Due to an Adverse Event|The safety and tolerability of the observed antiretroviral therapy were based on the Adverse Events (AEs) and Serious Adverse Events (SAEs) reported in the case report forms.|52 weeks|Full Analysis Set (FAS), all patients entered and treated||Number of patients|||Number
747692|NCT00531206|Secondary|Deaths|The safety and tolerability of the observed antiretroviral therapy were based on the Adverse Events (AEs) and Serious Adverse Events (SAEs) reported in the case report forms.|52 weeks|Full Analysis Set (FAS), all patients entered and treated||Number of patients|||Number
747693|NCT00531206|Secondary|Serious Adverse Events|The safety and tolerability of the observed antiretroviral therapy were based on the Adverse Events (AEs) and Serious Adverse Events (SAEs) reported in the case report forms.|52 weeks|Full Analysis Set (FAS), all patients entered and treated||Number of patients|||Number
747694|NCT00531206|Secondary|Subjective Well-being|Investigator’s opinion of patient’s general condition (quality of life)|52 weeks|Full Analysis Set (FAS), all patients entered and treated||participants|||Number
747695|NCT00531206|Secondary|CD4+ Cell Count|Change from baseline in CD4+ count over time|Baseline and 52 weeks|Full Analysis Set (FAS), all patients entered and treated||cells/mm3||Inter-Quartile Range|Median
747696|NCT00531206|Secondary|Change in Viral Load|Log10 change from baseline in viral load over time|Baseline and 52 weeks|Full Analysis Set (FAS), all patients entered and treated||log10 copies/ml||Inter-Quartile Range|Median
747697|NCT00531206|Primary|Adverse Events|The safety and tolerability of the observed antiretroviral therapy were based on the Adverse Events (AEs) and Serious Adverse Events (SAEs) reported in the case report forms.|52 weeks|Full Analysis Set (FAS), all patients entered and treated||Number of patients with adverse events|||Number
747698|NCT00531284|Secondary|Mean Residence Time (MRT) Extrapolated to Infinity for Carfilzomib||Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.|Safety population with available pharmacokinetic (PK) data. PK analyses were conducted in solid tumor and multiple myeloma groups only and were not conducted for lymphoma or participants enrolled under Amendment 4 (CFX + dexamethasone).||hours||Standard Deviation|Mean
747700|NCT00531284|Secondary|Clearance (CL) of Carfilzomib||Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.|Safety population with available pharmacokinetic (PK) data. PK analyses were conducted in solid tumor and multiple myeloma groups only and were not conducted for lymphoma or participants enrolled under Amendment 4 (CFX + dexamethasone).||liters/hour||Standard Deviation|Mean
747701|NCT00531284|Secondary|Elimination Half-life (t½) of Carfilzomib||Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.|Safety population with available pharmacokinetic (PK) data. PK analyses were conducted in solid tumor and multiple myeloma groups only and were not conducted for lymphoma or participants enrolled under Amendment 4 (CFX + dexamethasone).||hours||Full Range|Median
747702|NCT00531284|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) for Carfilzomib||Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.|Safety population with available pharmacokinetic (PK) data. PK analyses were conducted in solid tumor and multiple myeloma groups only and were not conducted for lymphoma or participants enrolled under Amendment 4 (CFX + dexamethasone).||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
747703|NCT00531284|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to the Last Concentration Measured (AUC0-last) for Carfilzomib||Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.|Safety population with available pharmacokinetic (PK) data. PK analyses were conducted in solid tumor and multiple myeloma groups only and were not conducted for lymphoma or participants enrolled under Amendment 4 (CFX + dexamethasone).||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
747704|NCT00531284|Secondary|Time to Maximum Observed Plasma Concentration (Tmax) of Carfilzomib||Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.|Safety population with available pharmacokinetic (PK) data. PK analyses were conducted in solid tumor and multiple myeloma groups only and were not conducted for lymphoma or participants enrolled under Amendment 4 (CFX + dexamethasone).||hours||Full Range|Median
747705|NCT00531284|Secondary|Maximum Observed Plasma Concentration of Carfilzomib|Plasma concentrations of carfilzomib were determined by a validated liquid chromatography tandem mass spectrometry method. Concentration values that were below the lower limit of quantification of 0.1 ng/mL were set to zero. Treatment groups receiving the same dose (e.g. 20 mg/m²) were combined for Day 1 analyses.|Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.|Safety population with available pharmacokinetic (PK) data. PK analyses were conducted in solid tumor and multiple myeloma groups only and were not conducted for lymphoma or participants enrolled under Amendment 4 (CFX + dexamethasone).||ng/mL||Geometric Coefficient of Variation|Geometric Mean
747706|NCT00531284|Secondary|Time to Progression|Time to Progression (TTP) is defined as number of months between start of treatment and first evidence/documentation of disease progression.|Tumor assessments occurred at the end of Cycle 2, 4, 6, 9, and 12 and continued every 3 cycles thereafter up to 6 months after last dose. Analysis includes data up to the data cut-off date of 07 October 2014; maximum duration of treatment was 35 months.|Safety population.||months||95% Confidence Interval|Median
747707|NCT00531284|Secondary|Progression-Free Survival|Progression-free survival (PFS) is the time from start of treatment to disease progression or death (due to any cause), whichever occurred first.|Tumor assessments occurred at the end of Cycle 2, 4, 6, 9, and 12 and continued every 3 cycles thereafter up to 6 months after last dose. Analysis includes data up to the data cut-off date of 07 October 2014; maximum duration of treatment was 35 months.|Safety population||months||95% Confidence Interval|Median
747708|NCT00531284|Secondary|Duration of Response|Duration of response is defined as the time from first evidence of a partial response or better (the first observation of PR before confirmation) to disease progression, with deaths owing to causes other than progression censored.|Tumor assessments occurred at the end of Cycle 2, 4, 6, 9, and 12 and continued every 3 cycles thereafter up to 6 months after last dose. Analysis includes data up to the data cut-off date of 07 October 2014; maximum duration of treatment was 35 months.|Safety Population with a partial response or better||months||95% Confidence Interval|Median
747709|NCT00531284|Secondary|Percentage of Participants With an Overall Response Throughout the Study|"Solid tumor participants were evaluated for disease response according to RECIST, Version 1.1. Multiple myeloma participants were evaluated using the International Myeloma Working Group (IMWG) Uniform Response Criteria with the addition of minimal response (MR) based on the European Group for Blood and Marrow Transplant Group (EBMT). Non-Hodgkin lymphoma (NHL) participants were evaluated using the International Workshop NHL criteria. Waldenström macroglobulinemia (WM) participants were evaluated using Criteria from the Sixth International Workshop for WM.
Overall response is defined in Outcome Measure 2 for participants with solid tumors. For NHL, overall response is defined as a best overall response of CR or PR. For multiple myeloma and WM, overall response is defined as participants with a best overall response of stringent complete response (sCR), CR, very good partial response (VGPR) or PR."|Tumor assessments occurred at the end of Cycle 2, 4, 6, 9, and 12 and continued every 3 cycles thereafter up to 6 months after last dose. Analysis includes data up to the data cut-off date of 07 October 2014; maximum duration of treatment was 35 months.|Safety Population||percentage of participants||95% Confidence Interval|Number
747727|NCT00524303|Other Pre-specified|Transcriptional Profiling of Total RNA and the Correlation to Response/Non-response to Treatment|Transcriptional data were of poor quality and thus could not be analyzed. Gene pathways that correlate with response/non-response to treatment were to have been evaluated. The unit of measure is unit less; however, the processed values would be considered normalized relative expression level.|Tumor core biopsy taken at Baseline and Treatment Day 14||||||
747901|NCT00525512|Secondary|Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 64 Weeks - Double-Blind Phase|FEV1 is the maximal amount of air you can forcefully exhale in one second.|baseline, 64 weeks|||liters||Standard Error|Least Squares Mean
747710|NCT00531284|Primary|Phase 2: Percentage of Participants With an Overall Response After 4 Treatment Cycles|"Overall response is defined as participants with a best overall response of complete response (CR), partial response (PR) or stable disease (SD) after 4 cycles, assessed by the Investigator using tumor measurement and according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
CR: Disappearance of all target and non-target lesions and no new lesions;
PR: Disappearance of all target lesions, persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits and no lesions, or, at least a 30% decrease in the size of target lesions and no progression of existing non-target lesions or any new lesions.
SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest size since the treatment started, and no progression of existing non-target lesions or any new lesions."|4 months|Phase 2 Safety population||percentage of participants||95% Confidence Interval|Number
747711|NCT00531284|Primary|Phase 1b: Number of Participants With Dose-limiting Toxicities (DLT)|"Participants were evaluated for dose-limiting toxicities according to the Common Terminology Criteria for Adverse Events (CTCAE) of the National Cancer Institute (NCI) version 3.0.
A DLT was defined as treatment-related ≥ Grade 2 neuropathy with pain, ≥ Grade 3 non-hematologic toxicity, Grade 4 neutropenia or thrombocytopenia lasting 7 or more days, or thrombocytopenia with bleeding.
The maximum tolerated dose (MTD) for each of the 3 populations (solid tumor, multiple myeloma, and lymphoma) was defined as the dose level at which < 33% of participants experienced a dose-limiting toxicity during the first 28-day cycle."|28 days|Dose-limiting toxicity analysis was based on subsets of the safety population including participants exposed to carfilzomib in Cycle 1 who experienced a DLT or completed 28 days of evaluation after the first dose of carfilzomib. Participants enrolled into the expansion cohorts (MTD dose expansion, carfilzomib + DEX) were not evaluated for DLT.||participants|||Number
747712|NCT00531427|Secondary|Sleep Disturbance Subscale of the MOS-Sleep Scale at Weeks 4, 8, and 12 of the Double-blind Phase.|The MOS Sleep Scale consists of 12 individual items (4 sleep disturbance, 2 sleep adequacy, 1 quantity of sleep and optimal sleep, 3 somnolence, 1 snoring, and 1 shortness of breath) and takes 5 to 10 minutes to complete. Question 1 is scored on a scale of 1 to 5 ( 1 = 0-15 min to more than 60 min) and Questions 2 to 12 are scored on a scale of 1 to 6 (1 = all of the time to 6 = none of the time. The Sleep Disturbance Subscale score is derived from the scores to Questions 1, 3, 7, and 8 and ranges from 0 to 100, where higher scores indicate greater sleep disturbance.|Weeks 4, 8, and 12 of the double-bind phase|Full Analysis Population (N = 570) consisted of subjects who were randomized and received at least 1 dose of double-blind study drug.||units on a scale||Standard Deviation|Mean
747713|NCT00531427|Secondary|Mean Daily Number of Tablets of Nonopioid Supplemental Analgesic Used From Week 2 to 12 of the Double-blind Phase.|Subjects were permitted to take sponsor-provided supplemental analgesic medication after week 1 of the double-blind treatment (acetaminophen or ibuprofen).|10 weeks|Subjects in the full analysis population who took at least 1 dose of supplemental analgesic medication.||tablets||Standard Deviation|Mean
747714|NCT00531427|Primary|"Average Pain Over the Last 24 Hours Score of the Study Knee at Week 12 of the Double Blind Phase."|"Average pain over the last 24 hours” scores of the study knee at week 12 was evaluated on an 11-point scale: 0 = no pain, 10 = worst pain imaginable, recorded daily."|24 hours (week 12)|The full analysis population is the group of subjects who were randomized and received at least 1 dose of double-blind study drug||units on a scale||Standard Deviation|Mean
747715|NCT00524134|Secondary|Prevalence of Medication Retention/Treatment Failure||16 weeks|The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in October 2009.|||||
747716|NCT00524134|Secondary|Prevalence of Seizure Freedom||12 weeks at highest tolerated dose|The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in October 2009.|||||
747717|NCT00524134|Secondary|Percent Change in Total Seizure Count Between Treatment Arms||12 weeks at highest tolerated dose|The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in October 2009.|||||
747718|NCT00524134|Primary|Proportion of Each Treatment Arm With ≥50% Reduction in Seizures||12 weeks at highest tolerated dose|The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in October 2009.|||||
747719|NCT00524225|Primary|Volume of Blood Transfusion|The volume of blood transfusion required (units of blood) after the surgical procedure.|4 weeks|||units of blood|||Number
747720|NCT00524225|Secondary|A Secondary Outcome Measure is the Frequency of IL-11 Associated Adverse Events.||The time frame is within 4 weeks of surgery.||||||
747721|NCT00524225|Secondary|A Secondary Outcome Measure is the Mechanism of IL-11 Effect by VWFmRNA.||4 weeks per subject||||||
747722|NCT00524225|Primary|Volume of Surgical Blood Loss|Hemostatic efficacy was measured by estimated blood loss (cc) during the surgical procedure.|4 weeks|||cc|||Number
747723|NCT00524264|Post-Hoc|Visual Acuity|Patients with ≥ 3 line improvement in visual acuity|Change from baseline at Day 14|Modified Intent-to-Treat Population||Percentage of patients with ≥ 3 lines|||Number
747724|NCT00524264|Secondary|Mean Pupil Area|Pupil area post-irrigation and aspiration|Day 0|Modified Intent-to-Treat Population||millimeters squared (mm²)||Standard Deviation|Mean
747725|NCT00524264|Secondary|Ocular Pain|Measured on a scale of 0-4 (0 = none, 4 = intolerable)|Day 1|Modified Intent-to-Treat Population||% of participants with a score of 0|||Number
747726|NCT00524264|Primary|Resolution of Post Operative Inflammation|Anterior chamber inflammation is the sum of biomicroscopic cell and flare; each measured on a scale of 0-4 (Flare: 0 = no flare, 4 = intense flare / Cell: 0 = no cells, 4 = >50 cells)|Day 14|Modified Intent-to-Treat Population||% of participants with a score of 0|||Number
747728|NCT00524303|Other Pre-specified|Cancer Stem Cells and the Correlation to Response/Non-response to Treatment|Stem cell data were of poor quality and thus could not be analyzed. Increases or decreases in cancer stem cells and how the changes correlated with response/non-response to treatment were to have been assessed.|Tumor core biopsy taken at Baseline and Treatment Day 14||||||
747729|NCT00524303|Other Pre-specified|Mean Intra-tumoral Expression of the Indicated Proteins at Baseline and Day 14|Expression (exp) of biomarker proteins (prot) were analyzed to determine if individual prot levels either in the Baseline or Day 14 breast tumor biopsy specimen correlated with breast pCR. A biomarker indicates a change in exp or state of a prot that correlates with the risk or disease progression, or with the susceptibility of the disease to a given treatment. Biomarkers are characteristic biological properties that can be detected and measured in parts of the body like blood or tissue. pCR=yes: participants (par.) had breast pCR. pCR=no: par. did not have breast pCR. Prot exp values are represented as normalized, scaled values; the unit of measurement is unit-less. Raw exp values were processed as follows: background subtraction of the raw exp value, then that value divided by beta-acting exp to normalize the exp value. A Standard Z score was calculated to scale the exp value.|Tumor core biopsy taken at Baseline and Treatment Day 14|ITT-E Population. Only those participants with matched pairs of biopsy samples for analysis at Baseline and on Day 14 were analyzed.||: normalized relative expression level||Standard Deviation|Mean
747730|NCT00524303|Secondary|Cumulative Number of Participants With at Least One Decrease of More Than or Equal to 20% in Left Ventricular Ejection Fraction (LVEF) at the Indicated Time Points Compared to LVEF at Baseline|LVEF is the measurement of how much blood is being pumped out of the left ventricle of the heart (the main pumping chamber) with each contraction and is used to determine cardiac function. LVEF was measured by performing echocardiogram (ECHO). If ECHO could not be performed or if the investigator believed that it was not conclusive to evaluate LVEF, then a multigated acquisition (MUGA) scan was performed.|Weeks 3, 9, and 15; EOT or early withdrawal; and 3- and 6-month survival follow-up after last chemotherapy course|Safety Population. Not all participants in the Safety Population were analyzed: some participants were randomized to an arm they did not want or participants were randomized in error (eligibility criteria weren’t met).||participants|||Number
747731|NCT00524303|Secondary|Number of Participants With the Indicated Electrocardiogram (ECG) Status at Baseline and at EOT or Early Withdrawal|12-lead ECGs were performed, and participants were classified as having normal ECG, abnormal- not clinically significant (NCS) ECG, and abnormal-clinically significant (CS) ECG per investigator opinion and reported result.|Baseline and EOT (up to Week 26) or Early withdrawal|Safety Population: all randomized participants (par) who received at least one dose of investigational product, based on actual treatment received if this differed from that to which par was randomized. Not all par were analyzed: some par were randomized to an arm they did not want or par were randomized in error (eligibility criteria weren’t met).||participants|||Number
747732|NCT00524303|Secondary|Percentage of Participants (Par.) With Disease-free Survival (DFS) at the End of 5 Years From Randomization|Percentage is the Kaplan Meier estimate of DFS. DFS is time from randomization until disease recurrence (contralateral breast cancer; second primary cancer; progression during neo-adjuvant treatment; or death from any cause). Par. who experienced progression during treatment and were withdrawn were considered to have a DFS event at withdrawal.|From first dose date until disease progression, assessed up to a maximum of 5 years|ITT Population||Percentage||95% Confidence Interval|Number
747733|NCT00524303|Secondary|Percentage of Participants With Clinical Complete Response (cCR) at 26 Weeks or at End of Treatment (EOT) or Early Withdrawal|cCR was defined as the percentage of participants achieving either a Complete Response (CR) or a Partial Response (PR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR was defined as the disappearance of all target lesions, and PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.|Week 26 or EOT or Early withdrawal|ITT Population: all randomized participants regardless of whether they had received any treatment.||percentage of participants|||Number
747734|NCT00524303|Primary|Percentage of Participants With Overall Pathological Complete Response (pCR) After 26 Weeks of Therapy|A pCR in the breast was defined as no pathologic evidence of invasive disease (residual ductal carcinoma in situ [DCIS] or lobular carcinoma in situ [LCIS] was allowed). A pCR in the axillary lymph node(s) was defined as no evidence of breast cancer cells in the lymph node (including subcapsular sinus). Overall pCR was defined as the sum of pCR in the breast and pCR in the lymph nodes. 26 weeks of therapy comprised the 2-week run-in phase, 12 weeks of treatment with FEC, and 12 weeks of treatment with Paclitaxel.|Week 26|Intent-to-Treat-Evaluable (ITT-E) Population: ITT participants with evaluable tumor responses who had been >=75% compliant to 5-fluorouracil (5-FU) 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 (FEC75) and paclitaxel 80 mg/m^2 and had undergone surgery.||percentage of participants|||Number
747735|NCT00524316|Secondary|Tumor Marker Response (AFP)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Baseline, week 7 and every 6 weeks after|All treated and eligible patients||percentage of participants||95% Confidence Interval|Number
747736|NCT00524316|Secondary|Assess the Change in the Quality of Life Among Patients Using the FACTHep (Version 4) for Hepatobiliary Cancers.|"We utilized the FACT-HEP TOTAL SCORE (version 4) quality-of-life scale, which is a 45 item scale ranging from 96-178. Higher scores reflect better quality of life.
No subscales were analyzed."|Baseline and Cycle 2|All treated and eligible patients||units on a scale||Standard Deviation|Mean
747737|NCT00524316|Secondary|Safety and Tolerability|"Number of participants with adverse advent.
Please refer to adverse event reporting for more detail."|Daily while on treatment through study completion, an average of 1 year|All treated and eligible patients||participants|||Number
747738|NCT00524316|Secondary|Tissue Perfusion, Ktrans, IAUC, and Percent Viable Tumor as Measured by DCE-MRI at Baseline and on Days 8 (Before Transarterial Chemoembolization), 10, and 35||Baseline, day 8, day 10, day 28 and day 35|Due to the study's early termination and inadequate number of patients, no data were collected for this Outcome Measure.|||||
747739|NCT00524316|Secondary|Overall Survival|median survival in months|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months|All treated and eligible patients||months||95% Confidence Interval|Median
747740|NCT00524316|Primary|Progression-free Survival|median progression free survival in months|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months|All treated and eligible patients.||months||95% Confidence Interval|Median
747741|NCT00524342|Secondary|A Secondary Outcome Measure is the Frequency of IL-11 Associated Adverse Events.||The time frame is up to 7 months per subject.|||participants|||Number
747742|NCT00524342|Secondary|A Secondary Outcome Measure is the Mechanism of IL-11 Effect by VWF mRNA.||The time frame is up to 7 months per subject.||||||
747743|NCT00524342|Primary|>50% Reduction in PBAC at 6 Months|Subjective estimate of blood loss was measured by using a Pictorial blood assessment chart (PBAC) . The PBAC measures scores on a scale where 0 to 100 is normal and greater than 100-200 are abnormal.|6 months|||percentage of participants|||Number
747744|NCT00524368|Secondary|Number of Participants Developing Mutations at Endpoint|Development of Mutations in Virologic Failures (Plasma Viral Load less than 50 Copies/mL) at endpoint.|48 weeks|Intent-to-Treat (ITT) population: Participants who were randomized and who received at least 1 dose of study medication.||Participants|||Number
747745|NCT00524368|Secondary|Predose Plasma Concentration (C0h) of DRV and Rtv.|Pharmacokinetic parameter C0h was assessed. Population Pharmacokinetic Estimates of DRV and rtv were evaluated.|0 hour predose and 1 hour post dose measured at Weeks 4 and 24. Any time point measured at Weeks 8 and 48|Intent-to-Treat (ITT) population: Participants who were randomized and who received at least 1 dose of study medication.||ng/mL||Full Range|Median
747746|NCT00524368|Secondary|Area Under the Curve From the Time of Study Medication Administration Upto 24 Hour Postdose (AUC24h) of DRV and Rtv|Pharmacokinetic parameter AUC24h was assessed from the time of study medication administration upto 24 hour postdose. Population Pharmacokinetic Estimates of DRV and rtv were evaluated.|0 hour predose and 1 hour post dose measured at Weeks 4 and 24. Any time point measured at Weeks 8 and 48.|Intent-to-Treat (ITT) population: Participants who were randomized and who received at least 1 dose of study medication.||ng*h/mL||Full Range|Median
747747|NCT00524368|Secondary|Percentage of Participants Adherent/Non-adherent to ARV as Determined by Modified Medication Adherence Self Report Inventory (M-MASRI) Questionnaire at Week 48|Self-reported adherence to the ARV medications was measured. The M-MASRI asks participants to report the number of doses taken, as well as the number of doses taken during the last 30 days prior to the study visit by means of a horizontal visual analogue scale (VAS) that generates a self-rated percentage of doses of all the ARV medications taken during the past 30 days.|48 weeks|Intent-to-Treat (ITT) population: Participants who were randomized and who received at least 1 dose of study medication.||Percentage of participants|||Number
747748|NCT00524368|Secondary|Change From Baseline in Total Functional Assessment of HIV Infection (FAHI) Score|The FAHI is a 44-item questionnaire and incorporates 5 functional scales (physical well-being, emotional well-being/living with HIV, functional and global well-being, social well-being, and cognitive functioning). Each scale included several questions (all 5 scales include total 44 questions). For each question, participants gave a score of either 0 (not at all), 1 (a little bit), 2 (somewhat), 3 (quite a bit) and 4 (very much). Total FAHI imputed score is calculated by adding scores for each question. The range of total FAHI score is 0 to 176. Higher scores indicate worsening.|48 weeks|Intention To Treat (ITT) population - last observation carried forward (LOCF): Intermittent missing values and missing values due to premature discontinuation were imputed with the last observation.||Scores on a scale||Full Range|Median
747749|NCT00524368|Secondary|Change in CD4+ Cell Count From Baseline|CD4+ cell count was calculated using the Last Observation Carried Forward (LOCF) algorithm.|48 Weeks|Intention To Treat (ITT) population - last observation carried forward (LOCF): Intermittent missing values and missing values due to premature discontinuation were imputed with the last observation.||10e6/l||Full Range|Median
747750|NCT00524368|Secondary|Time-averaged Difference (DAVG) of log10 Plasma Viral Load Over 48 Weeks||48 weeks|Intention To Treat (ITT) population: Observed cases||log10 copies/mL||Standard Error|Least Squares Mean
747751|NCT00524368|Secondary|Time to Loss of Virologic Response|Time taken to lose the virologic response ie, plasma viral load less than 50 copies/mL by participants.|48 weeks|Intention To Treat (ITT) population: Participants who permanently discontinued were considered nonresponders after discontinuation. Participants with intermittent missing viral load values were considered responders if preceeding and succeeding visits indicated response. Otherwise, intermittent values were imputed with nonresponse.||Days||Standard Error|Mean
747752|NCT00524368|Secondary|Time to Reach First Virologic Response|Time (in weeks) to achieve viral load less than 50 copies/mL by the participants.|48 weeks|Intention To Treat (ITT) population: Participants who permanently discontinued were considered nonresponders after discontinuation. Participants with intermittent missing viral load values were considered responders if preceeding and succeeding visits indicated response. Otherwise, intermittent values were imputed with nonresponse.||Days||Full Range|Median
747753|NCT00524368|Secondary|Change in log10 Viral Load From Baseline at Week 48||48 weeks|Intention To Treat (ITT) population: Participants who permanently discontinued were considered nonresponders after discontinuation. Participants with intermittent missing viral load values were considered responders if preceeding and succeeding visits indicated response. Otherwise, intermittent values were imputed with nonresponse.||log10 copies/mL||Full Range|Median
747754|NCT00524368|Secondary|Virologic Response at Week 48 (Viral Load Less Than 400 Copies/mL)|Number of participants with confirmed plasma viral load less than 400 copies/mL at Week 48.|48 weeks|Intention To Treat (ITT) population: Participants who permanently discontinued were considered nonresponders after discontinuation. Participants with intermittent missing viral load values were considered responders if preceeding and succeeding visits indicated response. Otherwise, intermittent values were imputed with nonresponse.||Participants|||Number
747773|NCT00524485|Primary|Protoporphyrin IX (PpIX) Accumulation as a Function of Skin Preparation, Aminolevulinic Acid Application Time, and Body Site|||Study was activated prior to RPCI putting a centralize data entry and data management. Data entry of the treatment arm assignments and outcomes was done by PI's staff and has since been lost. The PI died and all attempts to retrieve the data have failed.|||||
747774|NCT00524511|Secondary|Patient Satisfaction of Cosmesis of Surgical Wound|survey questionnaire using a visual analog scale to inquire about incision appearance, satisfaction with method of closure and comparison to previous closure type (if applicable)|before hospital discharge after surgery|No participants were analyzed due to poor enrollment, subjects lost to follow-up and incomplete/partial data.|||||
747755|NCT00524368|Primary|Virological Response at Week 48 (Number of Participants With Plasma Viral Load Less Than 50 Copies/mL) - as Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm|The TLOVR algorithm was used to derive response, ie, response and loss of response needed to be confirmed at 2 consecutive visits and participants who permanently discontinued were considered nonresponders after discontinuation. Participants with intermittent missing viral load values were considered responders if the preceeding and succeeding visits indicated response. In all other cases, intermittent values were imputed with nonresponse. Resuppression after confirmed virologic failure was considered as failure in this algorithm.|48 Weeks|Intention To Treat (ITT) population: Participants who permanently discontinued were considered nonresponders after discontinuation. Participants with intermittent missing viral load values were considered responders if preceeding and succeeding visits indicated response. Otherwise, intermittent values were imputed with nonresponse.||Participants|||Number
747756|NCT00524394|Primary|Cytokines|IL2 IL6 IL8 IL13 MIP1B MCP1 IL1B IL4 IL5 IL7 IL10 IL12P70 Measure of Cytokines presence and level .|O TO 30 DAYS OF LIFE|zero participant analyzed|||||
747757|NCT00524394|Primary|Immunological Homeostasis|"Describe changes in immunological homeostasis that indicate the normal function vs. presence of sepsis in newborn infants of various gestational ages"|0 to 30 days of life.||||||
747758|NCT00524420|Secondary|Adverse Events|Adverse events (AEs) were collected by open report of emergent symptoms or illness during the study. This form is filled out during baseline, daily before each TMS session by the trained physician administering the TMS, and at each follow-up visit.|Measured daily|||number of adverse events|||Number
747759|NCT00524420|Secondary|Hamilton Depression Rating Scale|The research coordinator administered the Hamilton Depression Rating Scale-17 item to assess the level of depression on a weekly basis at baseline, weeks 1, 2, 3 of TMS treatment and 1 week post-TMS treatment. Higher scores indicate a higher level of depression. Scores range from 0-50 and scores greater than 20 generally indicate moderate depression. Scores between 0-7 are considered normal.|Measured weekly|||units on a scale||Standard Deviation|Mean
747760|NCT00524420|Secondary|Gracely Box Unpleasantness Scale|The BURS is reliable, valid, and sensitive measure that has been used in a number of studies of analgesics and studies of changes of pain unpleasantness over time. Each scale is a 20 point scale that has clear anchor points. Pain unpleasantness is different from pain intensity in that it assesses the affective and not the somatic aspect of the pain. Lower scores indicate less unpleasantness of pain and higher scores indicate more unpleasantness of pain. This measure was administered at Baseline, after weeks 1, 2, and 3 of TMS treatment, and 1 week post-TMS.|Measured weekly|||units on a scale||Standard Deviation|Mean
747761|NCT00524420|Primary|Gracely Box Intensity Rating Scale|The BIRS is reliable, valid, and sensitive measure that has been used in a number of studies of analgesics and studies of changes of pain intensity over time and was selected as the primary outcome variable. Each scale is a 20 point scale that has clear anchor points. Patients will be classified as responders if they have a 4 point drop or more on the BIRS. In order to be randomized, subjects were to have had a BIRS score of at least 8. Lower scores indicate less pain and higher scores indicate more pain. This measure was administered once a week at Baseline, at the end of weeks 1, 2, and 3 of TMS treatment, and 1 week post-TMS treatment.|Measured weekly|||units on a scale||Standard Deviation|Mean
747762|NCT00524459|Secondary|Safety, in Terms of Neutropenia and Cardiac Toxicity||Every cycle during study treatment and 8 weeks post-treatment.|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.|||||
747763|NCT00524459|Secondary|Number of Women Who Would Have Required a Mastectomy Upfront But Who Underwent Breast Conservation Therapy Instead After Neoadjuvant Chemotherapy||Baseline (pre-treatment) surgical assessment, and post-chemotherapy surgical outcome.|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.|||||
747764|NCT00524459|Secondary|Overall Clinical Local Regional Response||Mammogram done pre-treatment and after four and six cycles of study chemotherapy treatment.|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.|||||
747765|NCT00524459|Primary|Clinical Complete Response||Surgery done after completion of six cycles of study chemotherapy treatment.|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.|||||
747766|NCT00524459|Primary|Pathological Complete Response||Mammogram done pre-treatment and after four and six cycles of study chemotherapy treatment.|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.|||||
747767|NCT00524485|Secondary|Extent That the PpIX is Photobleached by the Treatment Light in Incidental Lesions|||Study was activated prior to RPCI putting a centralize data entry and data management. Data entry of the treatment arm assignments and outcomes was done by PI's staff and has since been lost. The PI died and all attempts to retrieve the data have failed.|||||
747768|NCT00524485|Secondary|PpIX Accumulation in Incidental AK as a Function of Skin Preparation, Aminolevulinic Acid Application Time, and Body Site|||Study was activated prior to RPCI putting a centralize data entry and data management. Data entry of the treatment arm assignments and outcomes was done by PI's staff and has since been lost. The PI died and all attempts to retrieve the data have failed.|||||
747769|NCT00524485|Secondary|Histological Response|||Study was activated prior to RPCI putting a centralize data entry and data management. Data entry of the treatment arm assignments and outcomes was done by PI's staff and has since been lost. The PI died and all attempts to retrieve the data have failed.|||||
747770|NCT00524485|Secondary|Effects of Different Treatment Conditions on Efficacy|||Study was activated prior to RPCI putting a centralize data entry and data management. Data entry of the treatment arm assignments and outcomes was done by PI's staff and has since been lost. The PI died and all attempts to retrieve the data have failed.|||||
747771|NCT00524485|Secondary|Effects of Different Treatment Conditions on Acute Reactions of Actinic Keratoses (AK) and Sun Damaged Skin Occurring 24-48 Hours After Photodynamic Therapy|||Study was activated prior to RPCI putting a centralize data entry and data management. Data entry of the treatment arm assignments and outcomes was done by PI's staff and has since been lost. The PI died and all attempts to retrieve the data have failed.|||||
747772|NCT00524485|Primary|Extent That the PpIX is Photobleached by the Treatment Light|||Study was activated prior to RPCI putting a centralize data entry and data management. Data entry of the treatment arm assignments and outcomes was done by PI's staff and has since been lost. The PI died and all attempts to retrieve the data have failed.|||||
747775|NCT00524511|Primary|Wound Complication Rate|Wound seroma or hematoma, wound separation, wound requiring packing, cellulitis, required extra medical clinic visits to evaluate wound|within six weeks of study intervention|No participants were analyzed due to poor enrollment, subjects lost to follow-up and incomplete/partial data.|||||
747776|NCT00524537|Secondary|Healthcare Resource Utilization (HCRU): Mean Total Days In Hospital Due to CD at Each Study Visit|"The HCRU assesses the frequency of unscheduled outpatient visits, emergency room visits, or hospitalizations due to CD in the past 3 months. The mean total days in hospital in the past 3 months is presented at each timepoint. N=number of participants with data for total days in hospital at given timepoint."|Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months|"All participants in the All Treated Population (received at least 1 injection of Humira in the registry) with data for total days in hospital."||total days in hospital||Standard Deviation|Mean
747777|NCT00524537|Secondary|Healthcare Resource Utilization (HCRU): Mean Number Of Admissions to Hospital Due to CD at Each Study Visit|"The HCRU assesses the frequency of unscheduled outpatient visits, emergency room visits, or hospitalizations due to CD in the past 3 months. The mean number of admissions to hospital in the past 3 months is presented at each timepoint. N=number of participants with data for total days in hospital and at least one admission to hospital at given timepoint.."|Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months|"All participants in the All Treated Population (received at least 1 injection of Humira in the registry) with data for total days in hospital and at least one admission to hospital."||number of admissions to hospital||Standard Deviation|Mean
747778|NCT00524537|Secondary|Healthcare Resource Utilization (HCRU): Mean Number Of Visits At Emergency Room Due to CD at Each Study Visit|The HCRU assesses the frequency of unscheduled outpatient visits, emergency room visits, or hospitalizations due to CD in the past 3 months. The mean number of visits at emergency room in the past 3 months is presented at each timepoint. N=number of participants with at least one visit at given timepoint.|Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months|All participants in the All Treated Population (received at least 1 injection of Humira in the registry) with at least 1 visit at emergency room.||number of visits at emergency room||Standard Deviation|Mean
747779|NCT00524537|Secondary|Healthcare Resource Utilization (HCRU): Mean Number Of Visits At Physician's Office Due to CD at Each Study Visit|The HCRU assesses the frequency of unscheduled outpatient visits, emergency room visits, or hospitalizations for their CD in the past 3 months. The mean number of visits at physician's office in the past 3 months is presented at each timepoint. N=number of participants with at least one visit at given timepoint.|Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months|All participants in the All Treated Population (received at least 1 injection of Humira in the registry) with at least 1 visit at physician's office.||number of visits at physician's office||Standard Deviation|Mean
747780|NCT00524537|Secondary|WPAI:SHP: Change in Mean Percentage of Activity Impairment Due to Crohn’s Disease From Baseline to Each Visit|Activity impairment due to CD (the extent to which CD affected the ability to perform usual daily activities) is presented as the mean percentage of activity impairment, and is calculated as 100*scale value of WPAI question 6 (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. A negative change in score indicates improvement. N=the number of participants with available data at both baseline and given timepoint.|Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months|All participants in the All Treated Population (received at least 1 injection of Humira in the registry) with WPAI:SHP measurements.||percentage of activity impairment||Standard Deviation|Mean
747781|NCT00524537|Secondary|WPAI:SHP: Change in Mean Percentage of Overall Work Impairment Due to Crohn’s Disease From Baseline to Each Visit|The mean percentage of overall work impairment due to CD (based on the WPAI questionnaire) is presented, and is calculated as: Absenteeism (%) + extent to which CD decreased productivity (%)* [number of hours worked / (number of hours of work missed due to CD + number of hours worked)]. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. A negative change in score indicates improvement. N=the number of participants with available data at both baseline and given timepoint.|Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months|All participants in the All Treated Population (received at least 1 injection of Humira in the registry) with WPAI:SHP measurements.||percentage of overall work impairment||Standard Deviation|Mean
747782|NCT00524537|Secondary|WPAI:SHP: Change in Mean Percentage of Impairment While Working (Presenteeism) Due to Crohn’s Disease From Baseline to Each Visit|Presenteeism (the extent to which CD decreased productivity) is presented as the mean percentage of impairment while working due to CD, and is calculated as: 100*scale value of question 5 on the WPAI (between 0 and 10) / 10. WPAI:SHP is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. A negative change in score indicates improvement. N=the number of participants with available data at both baseline and given timepoint.|Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months|All participants in the All Treated Population (received at least 1 injection of Humira in the registry) with WPAI:SHP measurements.||percentage of impairment while working||Standard Deviation|Mean
747783|NCT00524537|Secondary|Work Productivity and Activity Impairment: Special Health Problem (WPAI:SHP): Change in Mean Percentage of Work Time Missed (Absenteeism) From Baseline to Each Visit|Absenteeism, presented as the mean percentage of work time missed due to Crohn's Disease (as reported on the WPAI:SHP), and is calculated as: 100*number of hours of work missed due to psoriasis / (number of hours of work missed due to psoriasis + number of hours worked). WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. A negative change in score indicates improvement. N=the number of participants with available data at both baseline and given timepoint.|Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months|All participants in the All Treated Population (received at least 1 injection of Humira in the registry) with WPAI:SHP measurements.||percentage of work time missed||Standard Deviation|Mean
747797|NCT00524680|Secondary|Toxicity|Number of treated patients that had serious adverse events.|Baseline, at 1, 3 and 6 months|All treated and eligible patients||participants|||Number
747784|NCT00524537|Secondary|Physician's Global Assessment of Disease Activity (PGA): Change From Baseline to Each Visit|The PGA measures the physician's assessment of the patient's current disease activity from using 6 assessments (general well-being, abdominal pain, diarrhea, blood in stool, abdominal mass, and Crohn's disease-related complications). The PGA score is the sum of the subscores and ranges from 0 (very good) to approximately 25 (very bad). A negative change in score indicates improvement. N=the number of participants with available data at both baseline and given timepoint.|Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months|All participants in the All Treated Population (received at least 1 injection of Humira in the registry) with PGA measurements.||units on a scale||Standard Deviation|Mean
747785|NCT00524537|Secondary|Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Total Score: Change From Baseline to Each Visit|The SIBDQ is a disease-specific health-related quality of life (HRQoL) questionnaire, able to detect and define meaningful clinical changes in inflammatory bowel disease (IBD) patients by measuring physical, social and emotional status. The SIBDQ consists of 10 questions, each question is scored on a scale from 1 (poor QoL) to 7 (good QoL). The scores are summed up and range from 10 (poor QoL) to 70 (good QoL). A higher score indicates a better HRQoL; a positive change from baseline indicates improvement. N=the number of participants with available data at both baseline and given timepoint.|Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months|All participants in the All Treated Population (received at least 1 injection of Humira in the registry) with SIBDQ measurements.||units on a scale||Standard Deviation|Mean
747786|NCT00524537|Primary|Number of Participants With Registry Treatment-Emergent Adverse Events (AEs)|"An AE is any untoward medical occurrence in a participant which does not necessarily have a causal relationship with this treatment. A serious AE (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Registry treatment-emergent AEs are defined as any event that began or worsened in severity after the first dose of Humira in the registry. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related.
For more details on adverse events please see the AE section below."|Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).|All Treated Population: All participants who received at least 1 injection of Humira in the registry||Participants|||Count of Participants
747787|NCT00524576|Secondary|Number of Participants Reporting Serious Adverse Events (SAE)|An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|During the 31-day follow-up period (Day 0-30) after the challenge dose|Analysis was performed on the Total Vaccinated Cohort. This table describes SAEs reported by all subjects including those enrolled in the Australian center.||participants|||Number
747788|NCT00524576|Secondary|Number of Participants Reporting Unsolicited Adverse Events (AE)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|During the 31-day follow-up period (Day 0-30) after the challenge dose|Analysis was performed on the Total Vaccinated Cohort. Data from the Australian center were not included following data quality issues detected at the investigator site.||participants|||Number
747789|NCT00524576|Secondary|Number of Participants Reporting Solicited General Symptoms|Solicited general symptoms assessed include fatigue, fever, gastrointestinal symptoms, and headache.|During the 4-day follow-up period (Day 0-3) after the challenge dose|Analysis was performed on the Total Vaccinated Cohort. Data from the Australian center were not included following data quality issues detected at the investigator site.||participants|||Number
747790|NCT00524576|Secondary|Number of Participants Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling.|During the 4-day follow-up period (Day 0-3) after the challenge dose|Analysis was performed on the Total Vaccinated Cohort. Data from the Australian center were not included following data quality issues detected at the investigator site.||participants|||Number
747791|NCT00524576|Secondary|Concentration of Anti-HBs Antibodies|Concentrations given as geometric mean concentration (GMC) and expressed in mIU/mL.|30 days post-challenge dose|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity. Data from the Australian center were not included following data quality issues detected at the investigator site.||mIU/mL||95% Confidence Interval|Geometric Mean
747792|NCT00524576|Secondary|Number of Participants With Anti-HBs Antibody Concentrations Above the Cut-off Value|Anti-HBs antibody cut-off values assessed include 3.3, 10 and 100 mIU/mL.|30 days post-challenge dose|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity. Data from the Australian center were not included following data quality issues detected at the investigator site.||participants|||Number
747793|NCT00524576|Primary|Number of Participants With Immunological Response to Challenge Dose in Terms of Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration|"Immune response defined as:
For initially seronegative subjects (anti-HBs antibody concentration <3.3 milli-international unit per milliliter [mIU/mL] before vaccination) antibody concentration ≥ 10mIU/mL at post booster.
For initially seropositive subjects: antibody concentration at post booster ≥ 4-fold the pre-vaccination antibody concentration."|30 days post-challenge dose|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity. Data from the Australian center were not included following data quality issues detected at the investigator site.||participants|||Number
747796|NCT00524680|Secondary|Occurrence of Infections, Deep Vein Thrombosis, Vascular Events, and Falls|Number of participant with occurrence of infections, deep venous thrombosis, vascular events and falls|Baseline, at 1, 3 ,6 months|All treated and eligible patients||participants|||Number
747798|NCT00524680|Secondary|Pattern of Response of Parathormone|Change from Baseline in PTH Levels at 1, 3, and 6 Months at dose levels 4000, 6000, 8000 and 10000 IU. Statistical analysis was done using one sample t-test.|Baseline, at 1, 3, 6 months|All treated and eligible patients||pg/mL||Standard Deviation|Mean
747799|NCT00524680|Primary|Pattern of Response of Serum 25(OH) D3 Levels|Change from Baseline in Serum 25(OH) D3 Levels at 1, 3, and 6 Months at dose levels 4000, 6000, 8000 and 10000 IU. Statistical analysis was done using one sample t-test.|Baseline, at 1, 3, 6 months|All treated and eligible patients||ng/mL||Standard Deviation|Mean
747800|NCT00524745|Secondary|Comparison of Antibody Response to HPV Type 11 1 Month Post-dose 3 for Each Alternative Schedule Compared to the Standard Schedule.||25 months|||GMT ratio||95% Confidence Interval|Number
747801|NCT00524745|Secondary|Comparison of Antibody Response to HPV Type 6 1 Month Post-dose 3 for Each Alternative Schedule Compared to the Standard Schedule.||25 months|||GMT ratio||95% Confidence Interval|Number
747802|NCT00524745|Primary|Comparison of Antibody Response to HPV Type 18 1 Month Post-dose 3 for Each Alternative Schedule Compared to the Standard Schedule.||25 months|||GMT ratio||95% Confidence Interval|Number
747803|NCT00524745|Primary|Comparison of Antibody Response to HPV Type 16 1 Month Post-dose 3 for Each Alternative Schedule Compared to the Standard Schedule.||25 months|||GMT ratio||95% Confidence Interval|Number
747804|NCT00524771|Primary|Number of Participants With Arterial Thromboembolism (ATE)|Arterial Thromboembolism (ATE) associated with the use of hormonal contraceptives that contain both an estrogen and progestin.|Time to event analysis within 48 months|||participants|||Number
747805|NCT00524771|Primary|Number of Participants With Venous Thromboembolism (VTE)|Venous thromboembolism (VTE) associated with the use of hormonal contraceptives that contain both an estrogen and progestin.|Time to event analysis within 48 months|Study participants that were not excluded due to protocol violations.||participants|||Number
747806|NCT00524940|Primary|Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Pre-vaccination and Post-vaccination.|GMTs and their 95% Confidence Interval are presented for each of the 3 antigens in the Fluzone® Vaccine 2007-2008 formulation.|21 days post-vaccination|The GMT were evaluated in the per-protocol Population||Titer||95% Confidence Interval|Geometric Mean
747807|NCT00524940|Primary|Solicited Injection Site and Solicited Systemic Reactions Post-vaccination.|Information concerning the safety of Fluzone® vaccine 2007-2008 formulation.|0-3 days post-vaccination and entire study duration|Safety analysis was on all enrolled and vaccinated participants, intend-to-treat Population.||Participants|||Number
747808|NCT00525031|Primary|Response to Neoadjuvant Therapy: Overall Clinical Responses|Response to neoadjuvant therapy reported as number of participants with clinical response, defined as Clinical Complete Response (CR): Disappearance of all clinical evidence of visible tumor. Partial Response (PR) : 30% or > decrease in the sum of the of the longest diameter of target lesions, taking as reference the baseline sum longest diameter persisting for at least 4 weeks. Progressive Disease (PD): > 20% increase in sum of longest diameter of target lesions, reference baseline sum longest diameter. Appearance new lesions and/or unequivocal progression of existing non-target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, reference smallest sum longest diameter since treatment started.|Evaluated after a total of 8 weeks of therapy before definitive surgery.|||Participants|||Count of Participants
747809|NCT00525031|Primary|Response to Neoadjuvant Therapy by Therapy Arms: Clinical Response Rates (CR + PR + SD)|Response to neoadjuvant therapy reported as number of participants with clinical response, defined as Complete Response (CR), Partial Response (PR) or Stable Disease (SD). Clinical Complete Response (CR): Disappearance of all clinical evidence of visible tumor. Partial Response (PR) : 30% or > decrease in the sum of the of the longest diameter of target lesions, taking as reference the baseline sum longest diameter persisting for at least 4 weeks. Progressive Disease (PD): > 20% increase in sum of longest diameter of target lesions, reference baseline sum longest diameter. Appearance new lesions and/or unequivocal progression of existing non-target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, reference smallest sum longest diameter since treatment started.|Evaluated after a total of 8 weeks of therapy before definitive surgery.|||Participants|||Count of Participants
747810|NCT00525135|Secondary|Survival||up to 10 years post-study treatment|Due to early termination, participants were not followed for survival after the primary outcome timeframe|||||
747811|NCT00525135|Primary|Decrease in Tumor Size|Number of participants with decreased tumor size after study treatment|Baseline, 16 weeks|||participants|||Number
747812|NCT00525135|Secondary|Side Effects of Drugs Affecting Quality of Life|Number of participants experiencing > Grade 1 adverse events (including fatigue) attributable to study treatment|17 weeks|||participants|||Number
747813|NCT00525135|Secondary|Increased Radioactive Iodine Uptake|Number of participants with increased radioiodine uptake on the Thyrogen scan post valproic acid therapy|Baseline, 10 weeks|||participants|||Number
747814|NCT00525135|Primary|Decrease in Thyroglobulin Level|Number of participants with decreased thyroglobulin level after study treatment|Baseline, 16 weeks|||participants|||Number
747815|NCT00525148|Secondary|Safety of BIBW 2992 as Indicated by Intensity and Incidence of Worst Adverse Events Graded According to NCI CTCAE Version 3.0|Safety of afatinib as indicated by intensity and incidence of worst adverse events graded according to National Cancer Institute (NCI) Common terminology criteria for adverse events (CTCAE) Version 3.0 (R04-0474).|First administration of trial medication until 28 days after last administration of trial medication, up to 93 months.|Treated set||Percentage of participants|||Number
747816|NCT00525148|Secondary|Safety of BIBW 2992 as Indicated by Incidence of Specified Adverse Events.|Safety of afatinib as indicated by incidence of specified adverse events: skin reactions (a preferred term of the system organ class: Skin and subcutaneous tissue disorders) and gastrointestinal (GI) (a system organ class).|First administration of trial medication until 28 days after last administration of trial medication, up to 93 months.|Treated set||Percentage of participants|||Number
747817|NCT00525148|Secondary|Cpre,ss,29|Predose concentration of the analyte in plasma at steady state immediately before administration of the 29th dose (Cpre,ss,29).|-0:05h (pre-dose) on Day 29|Treated Set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
752326|NCT00558272|Secondary|Saracatinib: Plasma Clearance at Steady State (CLss/F)||Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29|||L/h||Full Range|Median
747818|NCT00525148|Secondary|Overall Survival Time|Overall survival time (OS) was also evaluated and was defined as the duration of time from start of treatment to time of death up to 93 months, regardless of the cause of death. Medians are calculated from the Kaplan-Meier estimates and 95% confidence intervals, using Greenwood’s standard error estimate.|Start of treatment to time to all death, up to 93 months|Treated set||Months||95% Confidence Interval|Median
747819|NCT00525148|Secondary|Progression-free Survival|Progression-free survival (PFS) as per independent review was defined as the duration of time from the start of treatment until the day of objective tumor progression was confirmed by tumor imaging (Progressive Disease according to RECIST 1.0) or death, whichever came first. Patients with unknown progression status or unknown date of progression were reviewed on a case-by-case basis. Patients known to be alive without progression at the end of the trial or the last follow-up visit were censored at the date of the last imaging when the patient was known to be alive and progression-free. Medians are calculated from the Kaplan-Meier estimates and 95% confidence intervals, using Greenwood’s standard error estimate.|Response assessment is done at end of Week 4 (after Course 1), Week 8 (after Course 2), Week 12 (after Course 3) and at 8-week intervals thereafter, up to 93 months.|Treated Set||Months||95% Confidence Interval|Median
747820|NCT00525148|Secondary|Time to Objective Response|"Time to objective response was defined as the number of days from the start of treatment to the first recorded objective response. Patients who did not experience objective response during the study were censored at the time of treatment discontinuation.
The results are provided as the percentage of participants for this Outcome Measure."|Response assessment is done at end of Week 4 (after Course 1), Week 8 (after Course 2), Week 12 (after Course 3) and at 8-week intervals thereafter, up to 93 months.|Treated set||Percentage of participants|||Number
747821|NCT00525148|Secondary|Duration of Objective Response|Duration of objective response (OR) was measured from the time the criteria for CR or PR (whichever was documented first) were first met until the first date that progressive disease or death (or date of censoring for PFS) was objectively documented as per independent review.|Response assessment is done at end of Week 4 (after Course 1), Week 8 (after Course 2), Week 12 (after Course 3) and at 8-week intervals thereafter, up to 93 months.|Treated set including only patients with objective response.||Weeks||Standard Deviation|Mean
747822|NCT00525148|Secondary|Duration of Clinical Benefit|Duration of clinical benefit (disease control) as per independent review was defined as the time from the start of treatment to the time of progression or death (whichever occurred first), among patients with evidence of SD, PR or CR.|Response assessment is done at end of Week 4 (after Course 1), Week 8 (after Course 2), Week 12 (after Course 3) and at 8-week intervals thereafter, up to 93 months.|Treated Set||weeks||Standard Deviation|Mean
747823|NCT00525148|Secondary|Clinical Benefit as Determined by RECIST 1.0|Clinical benefit was evaluated according to RECIST 1.0 by independent review assessment. Patients whose best RECIST 1.0 assessment was stable disease (SD), partial response (PR), or complete response (CR) were considered to have derived a clinical benefit from treatment.|Response assessment is done at end of Week 4 (after Course 1), Week 8 (after Course 2), Week 12 (after Course 3) and at 8-week intervals thereafter, up to 93 months.|Treated set||Percentage of participants||95% Confidence Interval|Number
747824|NCT00525148|Primary|Objective Response (OR) as Determined by RECIST 1.0|Objective response (OR) was assessed for all treated patients by independent review as determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0. OR included complete response (CR) and partial response (PR), where CR or PR must have been confirmed by a subsequent response in ≥28 days.|Response assessment is done at end of Week 4 (after Course 1), Week 8 (after Course 2), Week 12 (after Course 3) and at 8-week intervals thereafter, up to 93 months.|Treated set: The patients who had taken at least one dose of afatinib were included in the treated set.||percentage of participants||95% Confidence Interval|Number
747825|NCT00525161|Secondary|Clinical Benefit Rate|Clinical benefit rate is defined as complete response, partial response, or stable disease (CR/PR/SD) as measured by Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for a minimum of at least 24 weeks.|24 weeks|||percentage of participants||95% Confidence Interval|Number
747826|NCT00525161|Secondary|Time to Progression||continuously|||months||95% Confidence Interval|Median
747827|NCT00525161|Primary|Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Patients were followed monthly for clinical and toxicity evaluation. Disease response by RECIST criteria v1.0 was assessed after 3 months by appropriate scans and these were obtained every 2 months thereafter until progression.|12 weeks after treatment & 8 weeks after initial documentation of response|one discontinued treatment after 2 weeks owing to a grade 3 rash and was not evaluable for response||participants|||Number
747828|NCT00525174|Secondary|Social Stigma From Treatment at 24 Weeks|The Parental Amblyopia Treatment Index consists of 18 likert-type questions evaluating the impact of treatment on the patient and family (2 of these questions pertain to social stigma of treatment). Questions are answered on a scale from 'Strongly Disagree' to 'Strongly Agree.' For analysis, values were coded numerically with integers from 5 (strongly agree) to 1 (strongly disagree) (0 was assigned to 'non-applicable' answers). The scores for these 2 questions were summed and averaged for each individual (total sums could range from 0 to 10). A mean across all individuals was computed.|24 weeks|||Units on a scale||Standard Deviation|Mean
747829|NCT00525174|Secondary|Social Stigma From Treatment at 6 Weeks|The Parental Amblyopia Treatment Index consists of 18 likert-type questions evaluating the impact of treatment on the patient and family (2 of these questions pertain to social stigma of treatment). Questions are answered on a scale from 'Strongly Disagree' to 'Strongly Agree.' For analysis, values were coded numerically with integers from 5 (strongly agree) to 1 (strongly disagree) (0 was assigned to 'non-applicable' answers). The scores for these 2 questions were summed and averaged for each individual (total sums could range from 0 to 10). A mean across all individuals was computed.|6 weeks|||Units on a scale||Standard Deviation|Mean
747870|NCT00525512|Secondary|Change From Baseline in Patient Global Evaluation at 64 Weeks - Double-Blind Phase|The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)|baseline, 64 weeks|||units on scale||Standard Error|Mean
752352|NCT00567840|Secondary|EBA Expressed as the Change in Time to Positive (TTP) Signal in Liquid Culture for M. Tuberculosis (Days 0-14)||Day 0 and Day 14|||hours/day||Standard Deviation|Mean
747830|NCT00525174|Secondary|Compliance With Treatment at 24 Weeks|The Parental Amblyopia Treatment Index consists of 18 likert-type questions evaluating the impact of treatment on the patient and family (7 of these questions pertain to compliance of treatment). Questions are answered on a scale from 'Strongly Disagree' to 'Strongly Agree.' For analysis, values were coded numerically with integers from 5 (strongly agree) to 1 (strongly disagree) (0 was assigned to 'non-applicable' answers). The scores for these 7 questions were summed and averaged for each individual (total sums could range from 0 to 35). A mean across all individuals was computed.|24 weeks|||Units on a scale||Standard Deviation|Mean
747831|NCT00525174|Secondary|Compliance With Treatment at 6 Weeks|The Parental Amblyopia Treatment Index consists of 18 likert-type questions evaluating the impact of treatment on the patient and family (7 of these questions pertain to compliance of treatment). Questions are answered on a scale from 'Strongly Disagree' to 'Strongly Agree.' For analysis, values were coded numerically with integers from 5 (strongly agree) to 1 (strongly disagree) (0 was assigned to 'non-applicable' answers). The scores for these 7 questions were summed and averaged for each individual (total sums could range from 0 to 35). A mean across all individuals was computed.|6 weeks|||Units on a scale||Standard Deviation|Mean
747832|NCT00525174|Secondary|Adverse Effects of Treatment on Patient and Family at 24 Weeks|The Parental Amblyopia Treatment Index consists of 18 likert-type questions evaluating the impact of treatment on the patient and family (8 of these questions pertain to adverse effects of treatment). Questions are answered on a scale from 'Strongly Disagree' to 'Strongly Agree.' For analysis, values were coded numerically with integers from 5 (strongly agree) to 1 (strongly disagree) (0 was assigned to 'non-applicable' answers). The scores for these 8 questions were summed and averaged for each individual (total sums could range from 0 to 40). A mean across all individuals was computed.|24 weeks|||Units on a scale||Standard Deviation|Mean
747833|NCT00525174|Secondary|Adverse Effects of Treatment on Patient and Family at 6 Weeks|The Parental Amblyopia Treatment Index consists of 18 likert-type questions evaluating the impact of treatment on the patient and family (8 of these questions pertain to adverse effects of treatment). Questions are answered on a scale from 'Strongly Disagree' to 'Strongly Agree.' For analysis, values were coded numerically with integers from 5 (strongly agree) to 1 (strongly disagree) (0 was assigned to 'non-applicable' answers). The scores for these 8 questions were summed and averaged for each individual (total sums could range from 0 to 40). A mean across all individuals was computed.|6 weeks|||Units on a scale||Standard Deviation|Mean
747834|NCT00525174|Secondary|Impact of Treatment on Patient and Family at 24 Weeks|The Parental Amblyopia Treatment Index consists of 18 likert-type questions evaluating the impact of treatment on the patient and family. Questions are answered on a scale from 'Strongly Disagree' to 'Strongly Agree.' For analysis, values were coded numerically with integers from 5 (strongly agree) to 1 (strongly disagree) (0 was assigned to 'non-applicable' answers). The scores were summed and averaged for each individual (total sums could range from 0 to 90; means could range from 0 to 5). A mean across all individuals was computed from the individual means.|24 weeks|||Units on a scale||Standard Deviation|Mean
747835|NCT00525174|Secondary|Impact of Treatment on Patient and Family at 6 Weeks|The Parental Amblyopia Treatment Index consists of 18 likert-type questions evaluating the impact of treatment on the patient and family. Questions are answered on a scale from 'Strongly Disagree' to 'Strongly Agree.' For analysis, values were coded numerically with integers from 5 (strongly agree) to 1 (strongly disagree) (0 was assigned to 'non-applicable' answers). The scores were summed and averaged for each individual (total sums could range from 0 to 90; means could range from 0 to 5). A mean across all individuals was computed from the individual means.|6 weeks|||Units on a scale||Standard Deviation|Mean
747836|NCT00525174|Secondary|Mean Change in Fellow Eye Visual Acuity From Baseline to 24 Weeks|Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) testing protocol resulting in a Snellen acuity score for 3 to <7 year olds; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds, resulting in a letter score that could range from 0 to 97 letters (0 worst; 97 best). Scores were converted to log of minimum angle of resolution (logMAR)(lower logMAR indicates better score). Change from baseline to 24 weeks was calculated. A positive difference indicates improvement (one logMAR line = 5 letters or one Snellen line).|Baseline to 24 weeks|||logMAR line||Standard Deviation|Mean
747837|NCT00525174|Secondary|Distribution of Change in Fellow Eye Visual Acuity From Baseline to 24 Weeks|Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) testing protocol resulting in a Snellen acuity score for 3 to <7 year olds; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds, resulting in a letter score that could range from 0 to 97 letters (0 worst; 97 best). Scores were converted to log of minimum angle of resolution (logMAR)(lower logMAR indicates better score). Change from baseline to 24 weeks was calculated. A positive difference indicates improvement (one logMAR line = 5 letters or one Snellen line).|Baseline to 24 weeks|||participants|||Number
747838|NCT00525174|Secondary|Distribution of Change in Randot Preschool Stereoacuity From Baseline to 24-week Outcome by Treatment Group: Subjects With Anisometropia and No Strabismus|The Randot Preschool Stereotest measures stereopsis from 800 to 40 seconds of arc. It is designed as a matching game in which the patient matches pictures in a test booklet wearing special glasses. A subject can fail the pretest (not see any pictures) or can score >800 (the worst), 800, 400, 200, 100, 60, or 40 (the best). If two shapes are identified correctly the patient moves to the next lower level. A failed test occurs when the patient cannot identify any shapes. A change of 1 level is a movement of 1 step in the scale (decrease shows improvement - ex. 100 to 60 is 1 level improved).|Baseline to 24 weeks|||participants|||Number
747839|NCT00525174|Secondary|Distribution of Change in Randot Preschool Stereoacuity From Baseline to 24-Week Outcome by Treatment Group: All Subjects|The Randot Preschool Stereotest measures stereopsis from 800 to 40 seconds of arc. It is designed as a matching game in which the patient matches pictures in a test booklet wearing special glasses. A subject can fail the pretest (not see any pictures) or can score >800 (the worst), 800, 400, 200, 100, 60, or 40 (the best). If two shapes are identified correctly the patient moves to the next lower level. A failed test occurs when the patient cannot identify any shapes. A change of 1 level is a movement of 1 step in the scale (decrease shows improvement - ex. 100 to 60 is 1 level improved).|Baseline to 24 weeks|||participants|||Number
747871|NCT00525512|Secondary|Change From Baseline in Patient Global Evaluation at 48 Weeks - Double-Blind Phase|The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)|baseline, 48 weeks|||units on scale||Standard Error|Mean
747840|NCT00525174|Secondary|Mean and SD of Change in Visual Acuity in the Amblyopic Eye From Baseline to 24-Week Outcome Examination According to Patient Characteristics|Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) testing protocol resulting in a Snellen acuity score for 3 to <7 year olds; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds, resulting in a letter score that could range from 0 to 97 letters (0 worst; 97 best). Scores were converted to log of minimum angle of resolution (logMAR)(lower logMAR indicates better score). Change from baseline to 24 weeks was calculated. A positive difference indicates improvement (one logMAR line = 5 letters or one Snellen line).|Baseline to 24 weeks|||logMAR line||Standard Deviation|Mean
747841|NCT00525174|Secondary|Distribution of Patient Characteristics at the 24-week Outcome Exam.|The distribution of the number of participants in each patient characteristic category at the 24-week outcome examination was found (for example, the number of participants at 24 weeks who were 3 to <5 years old at the time of enrollment).|24 weeks|||participants|||Number
747842|NCT00525174|Secondary|Distribution of Subjects With 3 or More Lines of Improvement|Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) testing protocol resulting in a Snellen acuity score for 3 to <7 year olds; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds, resulting in a letter score that could range from 0 to 97 letters (0 worst; 97 best). Scores were converted to log of minimum angle of resolution (logMAR)(lower logMAR indicates better score). Change from baseline to 24 weeks was calculated. A positive difference indicates improvement (one logMAR line = 5 letters or one Snellen line).|Baseline to 24 weeks|||participants|||Number
747843|NCT00525174|Secondary|Distribution of Subjects With >= 20/25 Amblyopic Eye Visual Acuity at 24 Weeks|Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol resulting in a Snellen acuity score that can range from 20/16 to 20/800 for ages 3 to <7; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. Scores were converted to log of minimum angle of resolution (logMAR) equivalents for analyses (lower logMAR value is better than higher logMAR).|24 weeks|||participants|||Number
747844|NCT00525174|Secondary|Distribution of Subjects With Interocular Difference <1 logMAR Line at 24 Weeks|Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) testing protocol resulting in a Snellen acuity score for 3 to <7 year olds; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds, resulting in a letter score that could range from 0 to 97 letters (0 worst; 97 best). Scores were converted to log of minimum angle of resolution (logMAR)(lower logMAR indicates better score). A positive interocular difference indicates worse acuity in the amblyopic eye (one logMAR line = 5 letters or one Snellen line).|24 weeks|||participants|||Number
747845|NCT00525174|Secondary|Mean Interocular Difference at 24 Weeks|Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) testing protocol resulting in a Snellen acuity score for 3 to <7 year olds; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds, resulting in a letter score that could range from 0 to 97 letters (0 worst; 97 best). Scores were converted to log of minimum angle of resolution (logMAR)(lower logMAR indicates better score). A positive interocular difference indicates worse acuity in the amblyopic eye (one logMAR line = 5 letters or one Snellen line).|24 weeks|||logMAR line||Standard Deviation|Mean
747846|NCT00525174|Primary|Mean Change in Amblyopic Eye Visual Acuity From Baseline to 24 Weeks|Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) testing protocol resulting in a Snellen acuity score for 3 to <7 year olds; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds, resulting in a letter score that could range from 0 to 97 letters (0 worst; 97 best). Scores were converted to log of minimum angle of resolution (logMAR)(lower logMAR indicates better score). Change from baseline to 24 weeks was calculated. A positive difference indicates improvement (one logMAR line = 5 letters or one Snellen line).|Baseline to 24 weeks|||logMAR line||Standard Deviation|Mean
747847|NCT00525174|Primary|Distribution of Change in Amblyopic Eye Visual Acuity Scores From Baseline to 24 Weeks|Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) testing protocol resulting in a Snellen acuity score for 3 to <7 year olds; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds, resulting in a letter score that could range from 0 to 97 letters (0 worst; 97 best). Scores were converted to log of minimum angle of resolution (logMAR)(lower logMAR indicates better score). 'Worse' indicates acuity at 24 weeks is worse than acuity at baseline; 'Better' indicates acuity at 24 weeks is better than acuity at baseline.|Baseline to 24 weeks|||participants|||Number
747848|NCT00525174|Primary|Mean (SD) of Amblyopic Eye Visual Acuity at 24 Weeks|Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol resulting in a Snellen acuity score that can range from 20/16 to 20/800 for ages 3 to <7; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. Scores were converted to log of minimum angle of resolution (logMAR) equivalents for analyses (lower logMAR value is better than higher logMAR).|24 weeks|||logMAR||Standard Deviation|Mean
747849|NCT00525174|Primary|Distribution of Visual Acuity in the Amblyopic Eye at 24 Weeks|Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol resulting in a Snellen acuity score that can range from 20/16 to 20/800 for ages 3 to <7; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. Scores were converted to log of minimum angle of resolution (logMAR) equivalents for analyses (lower logMAR value is better than higher logMAR).|24 weeks|||participants|||Number
747850|NCT00525265|Primary|Body Weight|The body weight change from baseline at the time of final trial drug administration|Baseline, at the time of final trial drug administration|||Kg||Standard Deviation|Mean
747851|NCT00525421|Secondary|Change in Serum C-reactive Protein and Serum Interleukin-6 Levels|Percentage changes from baseline to two weeks in C-Reactive protein (CLP) and interleukin-6 (IL-6).|2 weeks|||Percent change||Inter-Quartile Range|Median
747898|NCT00525512|Secondary|Pre-treatment Forced Vital Capacity (FVC) at 8 Weeks - Double-Blind Phase|FVC is the volume of air that can be forcibly blown out after full inspiration.|baseline, 8 weeks|||liters||Standard Error|Least Squares Mean
747852|NCT00525421|Primary|Percent Change From Baseline to Two Weeks in Symptoms and Signs of Oral Lichen Planus (OLP)|Numeric Rating Scale (NRS) is patient-reported numerical score for intensity of symptoms (range 0-10, where 0=no oral discomfort and 10=worst imaginable oral discomfort; symptom score over the last 1 week was recorded at baseline, and symptom score since baseline was recorded at follow-up. For Modified Oral Mucositis Index (MOMI) each of 16 oral sites is scored by an examiner for both erythema intensity (range 0-3 where 0=normal, 1=mild, 2=moderate, 3=severe) and area of ulceration (range 0-3 where 0=none, 1=>0-0.25 cm^2, 2= >0.25-1 cm^2, 3=>=1cm^2): right (R) and left (L) buccal mucosa, labial mucosa (upper and lower), lateral tongue (R and L), dorsum of tongue (R and L), ventral tongue and floor of mouth (R and L), maxillary gingiva (R and L), mandibular gingiva (R and L), and soft and hard palate. Total score for clinical signs (MOMI) is the sum of scores for 16 sites; separate scores for erythema and ulceration are the sums of respective scores.|2 weeks|||percent change||Inter-Quartile Range|Median
747853|NCT00525499|Secondary|Number of Participants With Improvement in Investigator Global Assessment by at Least One Grade From Baseline to Week 12|"The Investigator Global Assessment used a static categorical scale, with zero corresponding to no acne and higher scores reflecting more severe acne:
0 No acne lesions.
Rare non-inflammatory lesions.
Some non-inflammatory lesions, no more than a few inflammatory lesions. No nodulo-cystic lesions.
Many non-inflammatory lesions, some inflammatory lesions, no more than one nodulo-cystic lesion.
Many noninflammatory and inflammatory lesions but no more than a few nodulo-cystic lesions.
Highly inflammatory lesions, multiple nodulo-cystic lesions."|Baseline to Week 12|ITT population: All randomized subjects||Participants|||Number
747854|NCT00525499|Primary|Percent Change in Inflammatory Acne Lesion Counts From Baseline to Week 12|Percent change in inflammatory lesion counts from Baseline to Week 12. It is calculated by taking the Week 12 count minus the Baseline count and then dividing by the Baseline count. Thus, a negative percent change will reflect a reduction in lesion counts.|Baseline to Week 12|ITT population: All randomized subjects||Percent change||Standard Deviation|Mean
747855|NCT00525512|Secondary|Clinical Relevant Abnormalities for Vital Signs and Physical Examination, Including Vital Status|Clinical Relevant Abnormalities for Vital Signs and Physical examination, including vital status. Any new or clinically relevant worsening of baseline conditions was reported as Adverse Events.|From first drug administration until 30 days after last drug administration|||participants|||Number
747856|NCT00525512|Secondary|Saint George's Respiratory Questionnaire Symptoms Component Score at 100 Weeks - Open-Label Phase|Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.|baseline, 100 weeks|||units on scale||Standard Error|Least Squares Mean
747857|NCT00525512|Secondary|Saint George's Respiratory Questionnaire Impact Component Score at 100 Weeks - Open-Label Phase|Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.|baseline, 100 weeks|||units on scale||Standard Error|Least Squares Mean
747858|NCT00525512|Secondary|Saint George's Respiratory Questionnaire Activity Component Score at 100 Weeks - Open-Label Phase|Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.|baseline, 100 weeks|||units on scale||Standard Error|Least Squares Mean
747859|NCT00525512|Secondary|Saint George's Respiratory Questionnaire Total Score at 100 Weeks - Open-Label Phase|Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.|baseline, 100 weeks|||units on scale||Standard Error|Least Squares Mean
747860|NCT00525512|Secondary|Post-treatment Forced Vital Capacity (FVC) at 100 Weeks - Open-Label Phase|FVC is the volume of air that can be forcibly blown out after full inspiration.|baseline, 100 weeks|||liters||Standard Error|Least Squares Mean
747861|NCT00525512|Secondary|Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 100 Weeks - Open-Label Phase|FEV1 is the maximal amount of air you can forcefully exhale in one second.|baseline, 100 weeks|||liters||Standard Error|Least Squares Mean
747862|NCT00525512|Secondary|90% Constant Work Rate (CWR) Treadmill Endurance Time at 100 Weeks - Open-Label Phase|Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.|baseline, 100 weeks|||seconds||95% Confidence Interval|Least Squares Mean
747863|NCT00525512|Secondary|Patients With COPD Exacerbation (Survival Analysis) - Double-Blind Phase|COPD exacerbation is a complex of symptoms related to COPD with a duration of three days or more requiring a change of treatment.|baseline, 96 weeks|||participants|||Number
747864|NCT00525512|Secondary|Saint George's Respiratory Questionnaire Symptoms Component Score at 96 Weeks - Double-Blind Phase|Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.|baseline, 96 weeks|||units on scale||Standard Error|Least Squares Mean
747865|NCT00525512|Secondary|Saint George's Respiratory Questionnaire Impact Component Score at 96 Weeks - Double-Blind Phase|Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.|baseline, 96 weeks|||units on scale||Standard Error|Least Squares Mean
747866|NCT00525512|Secondary|Saint George's Respiratory Questionnaire Activity Component Score at 96 Weeks - Double-Blind Phase|Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.|baseline, 96 weeks|||units on scale||Standard Error|Least Squares Mean
747867|NCT00525512|Secondary|Saint George's Respiratory Questionnaire Total Score at 96 Weeks - Double-Blind Phase|Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.|baseline, 96 weeks|||units on scale||Standard Error|Least Squares Mean
747868|NCT00525512|Secondary|Change From Baseline in Patient Global Evaluation at 96 Weeks - Double-Blind Phase|The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)|baseline, 96 weeks|||units on scale||Standard Error|Mean
747869|NCT00525512|Secondary|Change From Baseline in Patient Global Evaluation at 80 Weeks - Double-Blind Phase|The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)|baseline, 80 weeks|||units on scale||Standard Error|Mean
747899|NCT00525512|Secondary|Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 96 Weeks - Double-Blind Phase|FEV1 is the maximal amount of air you can forcefully exhale in one second.|baseline, 96 weeks|||liters||Standard Error|Least Squares Mean
747872|NCT00525512|Secondary|Change From Baseline in Patient Global Evaluation at 32 Weeks - Double-Blind Phase|The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)|baseline, 32 weeks|||units on scale||Standard Error|Mean
747873|NCT00525512|Secondary|Change From Baseline in Patient Global Evaluation at 16 Weeks - Double-Blind Phase|The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)|baseline, 16 weeks|||units on scale||Standard Error|Mean
747874|NCT00525512|Secondary|Change From Baseline in Patient Global Evaluation at 8 Weeks - Double-Blind Phase|The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)|baseline, 8 weeks|||units on scale||Standard Error|Mean
747875|NCT00525512|Secondary|Change From Baseline in Physician Global Evaluation at 96 Weeks - Double-Blind Phase|The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)|baseline, 96 weeks|||units on scale||Standard Error|Mean
747876|NCT00525512|Secondary|Change From Baseline in Physician Global Evaluation at 80 Weeks - Double-Blind Phase|The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)|baseline, 80 weeks|||units on scale||Standard Error|Mean
747877|NCT00525512|Secondary|Change From Baseline in Physician Global Evaluation at 64 Weeks - Double-Blind Phase|The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)|baseline, 64 weeks|||units on scale||Standard Error|Mean
747878|NCT00525512|Secondary|Change From Baseline in Physician Global Evaluation at 48 Weeks - Double-Blind Phase|The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)|baseline, 48 weeks|||units on scale||Standard Error|Mean
747879|NCT00525512|Secondary|Change From Baseline in Physician Global Evaluation at 32 Weeks - Double-Blind Phase|The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)|baseline, 32 weeks|||units on scale||Standard Error|Mean
747880|NCT00525512|Secondary|Change From Baseline in Physician Global Evaluation at 16 Weeks - Double-Blind Phase|The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)|baseline, 16 weeks|||units on scale||Standard Error|Mean
747881|NCT00525512|Secondary|Change From Baseline in Physician Global Evaluation at 8 Weeks - Double-Blind Phase|The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)|baseline, 8 weeks|||unit on scale||Standard Error|Mean
747882|NCT00525512|Secondary|Borg Scale of Peak Leg Discomfort After 96 Weeks - Double-Blind Phase|Borg scale assessed degreee of discomfort on a scale from 0 (Nothing at all) to 10 (Maximal)|baseline, 96 weeks|||unit on scale||Standard Error|Least Squares Mean
747883|NCT00525512|Secondary|Borg Scale of Peak Dyspnea After 96 Weeks - Double-Blind Phase|Borg scale assessed degreee of discomfort on a scale from 0 (Nothing at all) to 10 (Maximal)|baseline, 96 weeks|||unit on scale||Standard Error|Least Squares Mean
747884|NCT00525512|Secondary|Borg Scale of Dyspnea at Isotime After 96 Weeks - Double-Blind Phase|Borg scale assessed degreee of discomfort on a scale from 0 (Nothing at all) to 10 (Maximal)|baseline, 96 weeks|||units on scale||Standard Error|Least Squares Mean
747885|NCT00525512|Secondary|Post-treatment Forced Vital Capacity (FVC) at 96 Weeks - Double-Blind Phase|FVC is the volume of air that can be forcibly blown out after full inspiration.|baseline, 96 weeks|||liters||Standard Error|Least Squares Mean
747886|NCT00525512|Secondary|Post-treatment Forced Vital Capacity (FVC) at 80 Weeks - Double-Blind Phase|FVC is the volume of air that can be forcibly blown out after full inspiration.|baseline, 80 weeks|||liters||Standard Error|Least Squares Mean
747887|NCT00525512|Secondary|Post-treatment Forced Vital Capacity (FVC) at 64 Weeks - Double-Blind Phase|FVC is the volume of air that can be forcibly blown out after full inspiration.|baseline, 64 weeks|||liters||Standard Error|Least Squares Mean
747888|NCT00525512|Secondary|Post-treatment Forced Vital Capacity (FVC) at 48 Weeks - Double-Blind Phase|FVC is the volume of air that can be forcibly blown out after full inspiration.|baseline, 48 weeks|||liters||Standard Error|Least Squares Mean
747889|NCT00525512|Secondary|Post-treatment Forced Vital Capacity (FVC) at 32 Weeks - Double-Blind Phase|FVC is the volume of air that can be forcibly blown out after full inspiration.|baseline, 32 weeks|||liters||Standard Error|Least Squares Mean
747890|NCT00525512|Secondary|Post-treatment Forced Vital Capacity (FVC) at 16 Weeks - Double-Blind Phase|FVC is the volume of air that can be forcibly blown out after full inspiration.|baseline, 16 weeks|||liters||Standard Error|Least Squares Mean
747891|NCT00525512|Secondary|Post-treatment Forced Vital Capacity (FVC) at 8 Weeks - Double-Blind Phase|FVC is the volume of air that can be forcibly blown out after full inspiration.|baseline, 8 weeks|||liters||Standard Error|Least Squares Mean
747892|NCT00525512|Secondary|Pre-treatment Forced Vital Capacity (FVC) at 96 Weeks - Double-Blind Phase|FVC is the volume of air that can be forcibly blown out after full inspiration.|baseline, 96 weeks|||liters||Standard Error|Least Squares Mean
747893|NCT00525512|Secondary|Pre-treatment Forced Vital Capacity (FVC) at 80 Weeks - Double-Blind Phase|FVC is the volume of air that can be forcibly blown out after full inspiration.|baseline, 80 weeks|||liters||Standard Error|Least Squares Mean
747894|NCT00525512|Secondary|Pre-treatment Forced Vital Capacity (FVC) at 64 Weeks - Double-Blind Phase|FVC is the volume of air that can be forcibly blown out after full inspiration.|baseline, 64 weeks|||liters||Standard Error|Least Squares Mean
747895|NCT00525512|Secondary|Pre-treatment Forced Vital Capacity (FVC) at 48 Weeks - Double-Blind Phase|FVC is the volume of air that can be forcibly blown out after full inspiration.|baseline, 48 weeks|||liters||Standard Error|Least Squares Mean
747896|NCT00525512|Secondary|Pre-treatment Forced Vital Capacity (FVC) at 32 Weeks - Double-Blind Phase|FVC is the volume of air that can be forcibly blown out after full inspiration.|baseline, 32 weeks|||liters||Standard Error|Least Squares Mean
747897|NCT00525512|Secondary|Pre-treatment Forced Vital Capacity (FVC) at 16 Weeks - Double-Blind Phase|FVC is the volume of air that can be forcibly blown out after full inspiration.|baseline, 16 weeks|||liters||Standard Error|Least Squares Mean
756044|NCT00591344|Secondary|Berg Balance Scale Score|This is a overall measure of balance|obtained during initial evaluation & then every 6 six months to end of 2-yr training period||||||
747902|NCT00525512|Secondary|Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 48 Weeks - Double-Blind Phase|FEV1 is the maximal amount of air you can forcefully exhale in one second.|baseline, 48 weeks|||liters||Standard Error|Least Squares Mean
747903|NCT00525512|Secondary|Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 32 Weeks - Double-Blind Phase|FEV1 is the maximal amount of air you can forcefully exhale in one second.|baseline, 32 weeks|||liters||Standard Error|Least Squares Mean
747904|NCT00525512|Secondary|Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 16 Weeks - Double-Blind Phase|FEV1 is the maximal amount of air you can forcefully exhale in one second.|baseline, 16 weeks|||liters||Standard Error|Least Squares Mean
747905|NCT00525512|Secondary|Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 8 Weeks - Double-Blind Phase|FEV1 is the maximal amount of air you can forcefully exhale in one second.|baseline, 8 weeks|||liters||Standard Error|Least Squares Mean
747906|NCT00525512|Secondary|Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 96 Weeks - Double-Blind Phase|FEV1 is the maximal amount of air you can forcefully exhale in one second.|baseline, 96 weeks|||liters||Standard Error|Least Squares Mean
747907|NCT00525512|Secondary|Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 80 Weeks - Double-Blind Phase|FEV1 is the maximal amount of air you can forcefully exhale in one second.|baseline, 80 weeks|||liters||Standard Error|Least Squares Mean
747908|NCT00525512|Secondary|Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 64 Weeks - Double-Blind Phase|FEV1 is the maximal amount of air you can forcefully exhale in one second.|baseline, 64 weeks|||liters||Standard Error|Least Squares Mean
747909|NCT00525512|Secondary|Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 48 Weeks - Double-Blind Phase|FEV1 is the maximal amount of air you can forcefully exhale in one second.|baseline, 48 weeks|||liters||Standard Error|Least Squares Mean
747910|NCT00525512|Secondary|Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 32 Weeks - Double-Blind Phase|FEV1 is the maximal amount of air you can forcefully exhale in one second.|baseline, 32 weeks|||liters||Standard Error|Least Squares Mean
747911|NCT00525512|Secondary|Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 16 Weeks - Double-Blind Phase|FEV1 is the maximal amount of air you can forcefully exhale in one second.|baseline, 16 weeks|||liters||Standard Error|Least Squares Mean
747912|NCT00525512|Secondary|Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 8 Weeks - Double-Blind Phase|FEV1 is the maximal amount of air you can forcefully exhale in one second.|baseline, 8 weeks|||liters||Standard Error|Least Squares Mean
747913|NCT00525512|Secondary|90% Constant Work Rate (CWR) Treadmill Endurance Time at 80 Weeks - Double-Blind Phase|Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.|baseline, 80 weeks|||seconds||95% Confidence Interval|Least Squares Mean
747914|NCT00525512|Secondary|90% Constant Work Rate (CWR) Treadmill Endurance Time at 64 Weeks - Double-Blind Phase|Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.|baseline, 64 weeks|||seconds||95% Confidence Interval|Least Squares Mean
747915|NCT00525512|Secondary|90% Constant Work Rate (CWR) Treadmill Endurance Time at 48 Weeks - Double-Blind Phase|Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.|baseline, 48 weeks|||seconds||95% Confidence Interval|Least Squares Mean
747916|NCT00525512|Secondary|90% Constant Work Rate (CWR) Treadmill Endurance Time at 32 Weeks - Double-Blind Phase|Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.|baseline, 32 weeks|||seconds||95% Confidence Interval|Least Squares Mean
747917|NCT00525512|Secondary|90% Constant Work Rate (CWR) Treadmill Endurance Time at 16 Weeks - Double-Blind Phase|Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.|baseline, 16 weeks|||seconds||95% Confidence Interval|Least Squares Mean
747918|NCT00525512|Secondary|90% Constant Work Rate (CWR) Treadmill Endurance Time at 8 Weeks - Double-Blind Phase|Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.|baseline, 8 weeks|||seconds||95% Confidence Interval|Least Squares Mean
747919|NCT00525512|Primary|90% Constant Work Rate (CWR) Treadmill Endurance Time at 96 Weeks - Double-Blind Phase|Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.|baseline, 96 weeks|Full Analysis Set (FAS) includes all treated participants with a baseline and any post-dosing exercise duration data||seconds||95% Confidence Interval|Least Squares Mean
747920|NCT00531453|Secondary|Percent of Participants Achieving Overall Combined Complete Response (CR) Following High-dose Chemotherapy (HDT)/Stem Cell Transplantation (SCT)|"Percent of Participants Achieving Overall Combined Complete Response (CR) (CR w/normalized serum κ:λ ratio + CR + Near Complete Response (nCR)) following stem cell transplantation.
CR criteria: negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow.
κ:λ ratio: normal free light chain (FLC) ratio
nCR criteria: positive immunofixation analysis of serum or urine as the only evidence of disease; disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow."|all data included in clinical database as of 10 April 2009|The response-evaluable population is defined as all subjects who have measurable disease at baseline, receive at least 1 dose of any study drug and have at least 1 post-transplantation response assessment. The response-evaluable population comprises 38 subjects in the VDT treatment group and 27 subjects in the VDTC group.||percentage of participants|||Number
747921|NCT00531453|Primary|Percent of Particpants Achieving Overall Combined Complete Response (CR) Following Induction|"Percent of Particpants Achieving Overall combined complete response (CR w/normalized serum κ:λ ratio + CR + near complete response (nCR)) following induction therapy.
CR criteria: negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow.
κ:λ ratio: normal free light chain (FLC) ratio
nCR criteria: positive immunofixation analysis of serum or urine as the only evidence of disease; disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow."|all data included in clinical database as of 10 April 2009|The response-evaluable population is defined as all subjects who have measurable disease at baseline, receive at least 1 dose of any study drug and have at least 1 post-baseline response assessment. The response-evaluable population comprises 49 subjects in the VDT treatment group and 48 subjects in the VDTC group.||percentage of participants|||Number
747922|NCT00531479|Secondary|Time to Death Due to Invasive Aspergillosis (IA)|Survival time from start of treatment. Time to death defined as date of death due to IA minus first treatment date + 1.|Day 1 to Day 84 (Week 12)|MITT; N = number of participants in MITT population at time of assessment. Participants who died due to causes other than IA were defined as censored at time of death.||days||Full Range|Median
747923|NCT00531479|Secondary|Time to Death: All-Cause Mortality|Survival time from start of treatment. Time to death defined as date of death due to any cause minus first treatment date + 1.|Day 1 to Day 84 (Week 12)|MITT; N = number of participants in MITT population at time of assessment.||days||Full Range|Median
747924|NCT00531479|Secondary|Mortality Due to Invasive Aspergillosis (IA) at Week 6 in Participants With Probable or Proven IA|Number of deaths due to Invasive Aspergillosis measured 6 weeks after start of treatment. Time to death defined as date of death minus first treatment date + 1.|Day 1 to Day 42 (Week 6)|MITT; N = number of participants in MITT population at Week 6. Participants who died due to causes other than IA before Week 6 were censored at their time of death in this analysis.||participants|||Number
747925|NCT00531479|Secondary|All-cause Mortality at Week 12 in Participants With Probable or Proven Invasive Aspergillosis (IA)|Number of deaths due to any cause measured 12 weeks after start of treatment. Time to death defined as date of death minus first treatment date + 1.|Day 1 to Day 84 (Week 12)|MITT; N=number of participants in MITT population at Week 12.||participants|||Number
747926|NCT00531479|Secondary|All-cause Mortality at Week 6 in Participants With Possible, Probable, or Proven Invasive Aspergillosis (IA)|Number of deaths due to any cause measured 6 weeks after start of treatment. Time to death defined as date of death minus first treatment date + 1.|Day 1 to Day 42 (Week 6)|Intent-to-treat (ITT) population: participants in MITT analysis set plus participants with possible IA who could not be upgraded to probable or proven IA within 7 days and had received at least 1 dose of study medication. N=number of participants in ITT population at Week 6.||participants|||Number
747927|NCT00531479|Secondary|Global Response at Week 6|Number of participants with a successful response (complete or partial global response). Complete response = resolution of all clinical signs and symptoms and >90% of lesions due to IA that were visible on radiologic studies at baseline (BL); partial response = clinical improvement and >50% improvement in radiological findings present at BL.|Baseline, Day 42 (Week 6)|MITT; N = number of participants in MITT population at Week 6. Missing data and participants who died at Week 6 were treated as failure.||participants|||Number
747928|NCT00531479|Primary|All-cause Mortality at Week 6 in Participants With Proven or Probable Invasive Aspergillosis|Number of deaths measured 6 weeks after start of treatment. Time to death defined as date of death minus first treatment date + 1.|Day 1 to Day 42 (Week 6)|Modified intent-to-treat (MITT) population: all randomized participants with proven or probable IA confirmed by Day 7 following enrollment who received at least 1 dose of study medication. N=number of participants in MITT population at Week 6. Participants not known to have died were censored at last study visit (Day 84).||participants|||Number
747929|NCT00531518|Primary|Psychotic Symptoms|Psychotic symptoms were assessed and scored using the Structured Interview for the Prodromal Syndrome (SIPS) and the Scale of Prodromal Symptoms (SOPS). The SOPS provides a measure of four domains of symptoms, including positive, negative, disorganized and general symptoms. The Positive Symptom sub-scale score reported is the sum of all five symptom items in the Positive Symptom sub-scale. The Positive Symptom sub-scale assesses psychotic symptoms, each item on a scale of 0-6. The sum scale score is 0-30, with 30 indicating severe psychotic symptoms, while 0 indicates no psychotic symptoms.|two years|||units on a scale||Standard Deviation|Mean
747930|NCT00531661|Other Pre-specified|Freedom From Pressure Sensor Failure||Study duration: average patient follow-up of 15 months|||participants|||Number
747931|NCT00531661|Other Pre-specified|Freedom From a Device/System-related Complication (DSRC)||Study duration: average patient follow-up of 15 months|||participants|||Number
747932|NCT00531661|Other Pre-specified|Rate of HFR Hospitalizations||Study duration: average patient follow-up of 15 months|||HFR hospitalizations/patient-year|||Number
747933|NCT00531661|Secondary|Quality of Life - Minnesota Living With Heart Failure Questionnaire (MLHFQ)|THe MLHFQ is patient self-assessment of how heart failure affects his or her daily life. To measure the effects of symptoms, functional limitations, psychological distress on an individual’s quality of life, the MLHFQ questionnaire asks each person to indicate using a 6-point, zero to five, Likert scale how much each of 21 facets prevented them from living as they desired. Total scores are provided as sums. The total score scale range is 0 - 105. A lower total score is indicative of better quality of life.|6 months|||units on a scale||Standard Deviation|Mean
747934|NCT00531661|Secondary|Days Alive Outside of the Hospital||6 months|||days||Standard Deviation|Mean
747935|NCT00531661|Secondary|Proportion of Patients Hospitalized for Heart Failure||6 months|||participants|||Number
747936|NCT00531661|Secondary|Change From Baseline in Pulmonary Artery Mean Pressure|Change from baseline in pulmonary artery mean pressure was calculated using an area under the curve (AUC) methodology. All patients were instructed to take daily home readings for 180 days. By patient, a baseline average for the first 7 days of home readings was calculated. The difference between baseline and each daily reading was then determined and a corresponding daily AUC value was calculated. Finally, all daily AUC values were summed over the entire 180 day period resulting in a total AUC per patient. These data were aggregated for each randomization group and then compared. The unit of measure is mmHg x Days.|6 months|||mmHg * days||Standard Deviation|Mean
747937|NCT00531661|Primary|Freedom From Pressure Sensor Failure|A pressure sensor failure occurs when the sensor malfunctions to the point that no readings can be obtained from it after all attempts are exhausted including troubleshooting the system to rule out any problems with the electronic components.|6 months|This Safety Endpoint was prespecified as an aggregate analysis of all patients implanted with the device. Results are not presented as an inter-arm comparison but rather against an objective performance criteria (OPC).||participants|||Number
747938|NCT00531661|Primary|Freedom From a Device/System-related Complication (DSRC).|"A DSRC is an adverse event that is, or is possibly, related to the HF Pressure Measurement System and at least one the following:
is treated with invasive means (other than intramuscular medication or a right heart catheterization with a Swan-Ganz measurement which is used for diagnostic purposes)
results in the death of the subject
results in the explant of the device"|6 months|This Safety Endpoint was prespecified as an aggregate analysis of all patients implanted with the device as well as patients where an implant was attempted. Results are not presented as an inter-arm comparison but rather against an objective performance criteria (OPC). This population includes 550 implanted patients + 25 patient attempts.||cases|Participants||Number
747939|NCT00531661|Primary|Rate of Heart Failure Related (HFR) Hospitalizations||6 months|||HFR hospitalizations/patient/6 months|||Number
747940|NCT00531752|Other Pre-specified|Treatment Duration|Treatment duration was defined as the total number of dosing days from first to last day of study drug administration in each period.|Day 1 up to Day 21|Safety analysis set consisted of all participants who took at least 1 dose of study medication.||days||Full Range|Mean
747941|NCT00531752|Other Pre-specified|Number of Participants With Change From Baseline in Physical Examination and Neurological Examination|Analysis include general physical examination and assessment of head, ears, eyes, ocular fundi, nose, mouth, throat, neck, thyroid, lungs, heart, breasts, abdomen and musculoskeletal system.|Baseline up to 1 week after last study dose (1 week after end of Period 2)|Safety analysis set consisted of all participants who took at least 1 dose of study medication.||participants|||Number
747942|NCT00531752|Other Pre-specified|Number of Participants With Clinically Significant Vital Sign Abnormalities|Criteria for potential clinical concern in vital signs: systolic blood pressure (BP) less than (<) 90 millimeters of mercury (mmHg), diastolic BP <50 mmHg, supine and sitting heart rate <40 beats per minute (bpm) or >120 bpm, standing and erect heart rate <40 bpm or >140 bpm. Maximum increase from baseline in systolic BP >=30 mmHg, maximum increase from baseline in diastolic BP >=20 mmHg.|Baseline up to 1 week after last study dose|Safety analysis set consisted of all participants who took at least 1 dose of study medication. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||participants|||Number
747943|NCT00531752|Other Pre-specified|Number of Participants With Electrocardiogram (ECG) Findings|Criteria for potential clinical concern in ECG parameters: maximum PR interval of greater than or equal to (>=) 300 milliseconds (msec), maximum QRS interval >=200 msec, maximum QTc interval of 450 to <480 msec, 480 to <500 msec and >=500 msec.|Baseline up to End of Treatment (Week 3 of period 2)|Safety analysis set consisted of all participants who took at least 1 dose of study medication. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||participants|||Number
747944|NCT00531752|Other Pre-specified|Number of Participants With Clinically Significant Laboratory Test Abnormalities|Laboratory parameters included hematology (hemoglobin, hematocrit, red blood cell count, platelets, leukocytes, total neutrophils, eosinophils, basophils, lymphocytes, monocytes); liver function (total bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, albumin, total protein); renal function (creatinine, blood urea nitrogen, uric acid, sodium, potassium, chloride, bicarbonate, calcium); urinalysis (protein, blood), and clinical chemistry (glucose).|Baseline up to 1 week after last study dose|Safety analysis set consisted of all participants who took at least 1 dose of study medication. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||participants|||Number
747945|NCT00531752|Other Pre-specified|Change From Baseline in Subjective Sleep Questionnaire (SSQ) Quality of Sleep Subscale Scores at Week 1, 2 and 3|"SSQ is a 5-item self-report scale that was designed to evaluate the amount and quality of sleep and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), WASO (1 item), quality of sleep (1 item).
Quality of sleep subscale score ranges from 0-100. Higher score indicates better quality of sleep."|Baseline, Week 1, 2, 3|PP analysis set: all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here ‘n’ signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.||units on a scale||Standard Deviation|Mean
747946|NCT00531752|Other Pre-specified|Change From Baseline in Subjective Sleep Questionnaire (SSQ) Total Awake After Sleep Onset (WASO) Subscale Scores at Week 1, 2 and 3|"SSQ is a 5-item self-report scale that was designed to evaluate the amount and quality of sleep and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), WASO (1 item), quality of sleep (1 item).
Total WASO subscale score ranges from 0 to 24 hours. Lower value indicates better sleep."|Baseline, Week 1, 2, 3|PP analysis set: all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here ‘n’ signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.||hours||Standard Deviation|Mean
747947|NCT00531752|Other Pre-specified|Change From Baseline in Subjective Sleep Questionnaire (SSQ) Number of Awakenings Subscale Scores at Week 1, 2 and 3|"SSQ is a 5-item self-report scale that was designed to evaluate the amount and quality of sleep and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), WASO (1 item), quality of sleep (1 item).
Number of awakenings subscale score ranges from 0 to 30. Lower value indicates better sleep."|Baseline, Week 1, 2, 3|PP analysis set: all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here ‘n’ signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.||awakenings||Standard Deviation|Mean
747948|NCT00531752|Other Pre-specified|Change From Baseline in Subjective Sleep Questionnaire (SSQ) Hours of Sleep Subscale Scores at Week 1, 2 and 3|"SSQ is a 5-item self-report scale that was designed to evaluate the amount and quality of sleep and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), WASO (1 item), quality of sleep (1 item).
Hours of sleep subscale score ranges from 0-16 hours. Higher value indicates better sleep."|Baseline, Week 1, 2, 3|PP analysis set: all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here ‘n’ signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.||hours||Standard Deviation|Mean
747949|NCT00531752|Other Pre-specified|Change From Baseline in Subjective Sleep Questionnaire (SSQ) Latency Subscale Scores at Week 1, 2 and 3|SSQ is a 5-item self-report scale that was designed to evaluate the amount and quality of sleep and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), total awake after sleep onset (WASO [1 item]), quality of sleep (1 item). Latency subscale score ranges from 0-840 minutes. Lower value indicates better sleep.|Baseline, Week 1, 2, 3|PP analysis set: all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here ‘n’ signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.||minutes||Standard Deviation|Mean
748031|NCT00532779|Primary|Co-primary: Body Weight- Proportion of Subjects With ≥5% Decrease||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||percentage of participants||95% Confidence Interval|Number
747950|NCT00531752|Other Pre-specified|Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3|Participant-rated 12-item questionnaire to assess sleep quality and quantity. The items contribute to each scale and are averaged to create the 7 subscale scores: sleep disturbance, snoring, awaken short of breath (ASoB) or with a headache, somnolence, sleep adequacy, sleep quantity (range 0 to 24) and optimal sleep, and overall sleep problem index (SPI) I (range 0 to 600) and II. Except for sleep quantity and sleep problem index I, scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute. Except for sleep quantity, higher scores=greater impairment. Scales with at least one item answered was used to generate a scale score.|Baseline, Week 1, 2, 3|PP analysis set: all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here ‘n’ signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.||units on a scale||Standard Deviation|Mean
747951|NCT00531752|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Subscale Scores at Week 3|SDS was a participant-rated questionnaire assessing the effect of the participant's symptoms on the 3 domains/subscales: work/school, social life/leisure activities, and family/home management. Each domain was rated on visual analog scale ranges from 0 to 10 where 0=not at all impaired and 10=extremely impaired, and total SDS score was calculated as a sum of all the domains with a score range of 0=not at all impaired to 30=extremely impaired. Disability scores were reported for each of the domains/subscales. Higher scores reflect greater impairment.|Baseline, Week 3|PP analysis set: all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here ‘n’ signifies those participants who were evaluable for given subscale at specified time points for each arm, respectively.||units on a scale||Standard Deviation|Mean
747952|NCT00531752|Secondary|Change From Baseline in Adult ADHD Quality of Life Scale (AAQOL) Subscale Score at Week 3|AAQoL is a 29-item questionnaire consisting of 4 subscales: life productivity (11 items), psychological health ([PH] 6 items), life outlook (7 items) and relationships (5 items). Participants rated each item on a scale ranging from 1 (not at all/never) to 5 (extremely/very often). The scores of each item were then transformed to a 0 to 100 point scale, higher scores indicating better quality of life. The score for each subscale was calculated as the sum of the corresponding item scores. Total score ranges were: life productivity (0 to 1100), psychological health (0 to 600), life outlook (0 to 700) and relationships (0 to 500), where higher subscale score indicates better quality of life for each subscale.|Baseline, Week 3|PP analysis set: all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here ‘n’ signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.||units on a scale||Standard Deviation|Mean
747953|NCT00531752|Secondary|Change From Baseline in ADHD Impact Module – Adults (AIM-A) Subscale Score at Week 3|AIM-A: 66 item questionnaire completed by the participant to assess the impact of ADHD on the participant’s quality of life. It is comprised of 4 global quality of life (QoL) items (current quality of life item [CQoLI], range:1 to 10; global limitation item [GLI]: range:1 to 4, on the right track item [RTI], range:1 to 3, more good days [GD] than bad days [BD], range:1 to 5, higher scores indicate a better QoL for all the 4 QoL items) and 6 multi-item subscales (living with ADHD, general well-being, performance and daily functioning [PDF], relationships and communication [R/C], Impact of symptoms-bother/concern [IS-B/C] scale, and impact of symptoms-interference [IS-I] scale). Participants responded to each item of multi-item subscale using a likert scale ranging from 1 (strongly agree) to 5 (strongly disagree). Multi-item subscale scores were calculated as an average of scores for the contributing items and transformed into 0 to 100 score where higher scores indicate a better QoL.|Baseline, Week 3|PP analysis set: all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here ‘n’ signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.||units on a scale||Standard Deviation|Mean
747954|NCT00531752|Secondary|Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Week 3|HAM-A is a clinician-rated 14 item scale that provides an overall measure of global anxiety, including psychic (mental agitation and psychological distress) and somatic (physical complaints related to anxiety) symptoms. Each item was scored on a scale ranging from 0 (not present) to 4 (very severe) with a total score range of 0 to 56, where higher score indicates greater anxiety.|Baseline, Week 3|PP analysis set: all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here ‘n’ signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.||units on a scale||Standard Deviation|Mean
747955|NCT00531752|Secondary|Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score at Week 3|The MADRS scale measures the depression level of a participant. It is administered as a semi-structured clinician interview. The total score is derived by adding the scores of the following 10 items: (1) Apparent sadness; (2) Reported sadness; (3) Inner tension; (4) Reduced sleep; (5) Reduced appetite; (6) Concentration difficulties; (7) Lassitude; (8) Inability to feel; (9) Pessimistic thoughts; (10) Suicidal thoughts. Each item is scored using a 6-point scale which ranges from 0 to 6 (a higher score indicates increased severity). The total score range was 0 to 60 where 0 indicates no depression and 60 indicates severely depressed.|Baseline, Week 3|PP analysis set: all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here ‘n’ signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.||units on a scale||Standard Deviation|Mean
747956|NCT00531752|Secondary|Change From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Total Score on Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 21|TASS: a time sensitive 18-item questionnaire completed by the participant that measured the severity of current ADHD symptoms. It included 9 items that evaluate symptoms of inattention sub-scale and 9 items that evaluate symptoms of impulsivity and hyperactivity sub-scale. Each item was rated from 0 (none) to 3 (severe). TASS total score was calculated as sum of all the items on the scale and ranged from 0 to 54. A higher total score corresponded to a worse severity of ADHD. TASS was administered each day from Day 1 to 14 and on Day 21 in each intervention period.|Baseline, Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 21|Analysis population included all participants in PP analysis set and 1 additional participant in PF-03654746 (Flexible Dose) for whom the post-baseline data was available.‘N’ (number of participants analyzed)=evaluable participants for this measure and ‘n’= evaluable participants for this measure at specified time points for each arm, respectively.||units on a scale||Standard Deviation|Mean
747957|NCT00531752|Secondary|Change From Baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) Subscale Scores at Week 1, 2 and 3|AISRS: an 18-item scale administered by the investigator. It included 9 items that evaluated symptoms of inattention and 9 items that evaluated symptoms of impulsivity and hyperactivity. Each item was rated from 0 (none) to 3 (severe). The AISRS inattention and hyperactive/impulsive total subscale score range from 0 to 27. A higher total subscale score corresponded to a worse severity of ADHD inattention or hyperactivity/impulsivity.|Baseline, Week 1, 2, 3|PP analysis set:all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.||units on a scale||Standard Deviation|Mean
747958|NCT00531752|Secondary|Percentage of Participants With Sustained Response of at Least 30 Percent Decrease From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Total Score|TASS: a time sensitive 18-item questionnaire completed by the participant that measured the severity of current ADHD symptoms. It included 9 items that evaluate symptoms of inattention sub-scale and 9 items that evaluate symptoms of impulsivity and hyperactivity sub-scale. Each item was rated from 0 (none) to 3 (severe). TASS total score was calculated as sum of all the items on the scale and ranged from 0 to 54. A higher total score corresponds to a worse severity of ADHD. TASS was administered each day from Day 1 to 14 and on Day 21 in each intervention period. Participants with sustained response were those who had at least 30 percent decrease from baseline in TASS total score, which was maintained at all visits up to the time of assessment. Sustained responders at Day 7, 14 and 21 were analyzed.|Day 7, 14, 21|PP analysis set: all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.||percentage of participants|||Number
747959|NCT00531752|Secondary|Percentage of Participants With Less Than or Equal to 18 Score on Adult ADHD Investigator Symptom Rating Scale (AISRS)|AISRS: an 18-item scale administered by the investigator. It included 9 items that evaluated symptoms of inattention and 9 items that evaluated symptoms of impulsivity and hyperactivity. Each item was rated from 0 (none) to 3 (severe). AISRS total score was calculated as sum of all the items on the scale and ranged from 0 to 54. A higher score corresponded to a worse severity of ADHD.|Week 1, 2, 3|PP analysis set:all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.||percentage of participants|||Number
747960|NCT00531752|Secondary|Percentage of Participants With 1 or 2 Score on Clinical Global Impression-Severity Scale (CGI-S)|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Participants with a score of 1 (normal - not ill at all) or 2 (borderline mentally ill) are reported.|Week 1, 2, 3|PP analysis set:all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.||percentage of participants|||Number
747961|NCT00531752|Secondary|Percentage of Participants With at Least 30 Percent Decrease From Baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) Total Score|AISRS: an 18-item scale administered by the investigator. It included 9 items that evaluated symptoms of inattention and 9 items that evaluated symptoms of impulsivity and hyperactivity. Each item was rated from 0 (none) to 3 (severe). AISRS total score was calculated as sum of all the items on the scale and ranged from 0 to 54. A higher score corresponded to a worse severity of ADHD.|Week 1, 2, 3|PP analysis set:all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.||percentage of participants|||Number
747962|NCT00531752|Secondary|Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Total Score at Week 1 and 2|AISRS: an 18-item scale administered by the investigator. It included 9 items that evaluated symptoms of inattention and 9 items that evaluated symptoms of impulsivity and hyperactivity. Each item was rated from 0 (none) to 3 (severe). AISRS total score was calculated as sum of all the items on the scale and ranged from 0 to 54. A higher score corresponded to a worse severity of ADHD.|Baseline, Week 1, 2|PP analysis set:all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.||units on a scale||Standard Deviation|Mean
747963|NCT00531752|Primary|Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Total Score at Week 3|AISRS: an 18-item scale administered by the investigator. It included 9 items that evaluated symptoms of inattention and 9 items that evaluated symptoms of impulsivity and hyperactivity. Each item was rated from 0 (none) to 3 (severe). AISRS total score was calculated as sum of all the items on the scale and ranged from 0 to 54. A higher score corresponded to a worse severity of ADHD.|Baseline, Week 3|Per Protocol (PP) set: all participants included in full analysis set (FAS=who received at least[>=]1 dose of randomized study drug,had baseline and >=1 post-baseline measurement of primary efficacy variable)and had no major protocol violation affecting primary efficacy variable. n=participants evaluable at specified time points for each arm.||units on a scale||Standard Deviation|Mean
748002|NCT00532493|Secondary|Alcohol Use Disorders Identification Test-Consumption (AUDIT-C)|Change from baseline in possible range for Audit-C score is 0-12. Higher score indicates heavier use of alcohol. A score of >=4 for male and a score of >=3 for female meets the criteria for alcohol use disorders.|This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination).|11 participants in the prazosin group have missing data on this item at one or more of the follow-up weeks; 9 participants in the placebo group have missing data at one or more of the follow-up weeks||scores on a scale||Standard Deviation|Mean
747964|NCT00532129|Secondary|Mean Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Scores|EORTC QLQ-C30: included global health status (GHS)/quality of life (QOL), functional scales (physical, role, cognitive, emotional, and social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulties). Most questions used a 4- point scale (1 'Not at All' to 4 'Very Much'); 2 questions used a 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores were averaged and transformed to 0-100 scale; a higher score for Global Qol/functional scales=better level of QoL/functioning, or a higher score for symptom scale=greater degree of symptoms.|Baseline, Day 1 of Cycles 5 and 11, end of follow-up (FU) (24 month [m] FU visit, up to approximately 3 years)|FAS. Number of participants analyzed = number of participants evaluable for this outcome and n=number of participants evaluable at the specified time point.||units on scale||Standard Deviation|Mean
747965|NCT00532129|Secondary|Percentage of Participants Who Achieved Minimal Residual Disease (MRD) Negativity|MRD negativity was defined by the absence of tumor cells in bone marrow, using 4-color flow cytometry. MRD was assessed in participants with a confirmed CR. CR was achieved if all of the following criteria were met for ≥8 weeks: a)Absence of LD by PE and CT scan, b)No HM/SM by PE/CT scan, c)Absence of B symptoms, d)Normal CBC, and e)BM biopsy: normocellular for age, <30% of the cells being Lym and LN absent.|Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)|FAS population participants who achieved confirmed CR.||percentage of participants|||Number
747966|NCT00532129|Secondary|Overall Survival (OS) Time|This was defined as the interval (number of days) from the trial treatment start date to the date of death by any cause. Participants who were alive at the time of the analysis were censored at the date of the last follow-up assessment.|Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)|FAS.||percentage of participants||95% Confidence Interval|Median
747967|NCT00532129|Secondary|Percentage of Participants Who Died||Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)|FAS.||percentage of participants|||Number
747968|NCT00532129|Secondary|Duration of Response (DoR)|DoR: defined as interval (in days) from first tumor response (of CR/PR/nPR) to earlier of date of PD/death. Participants without PD/death or who were lost to follow-up were censored. CR: a)Absence of LD by PE and CT, b)No HM/SM by PE/CT, c)Absence of B symptoms, d)Normal CBC, and e)BM biopsy: normocellular for age, <30% of the cells being Lym and LN absent. PR: a)≥50% decrease in Lym count from baseline value, b)≥50% reduction in LD, c)≥50% reduction in size of liver/spleen by PE/CT scan and d)Leuk, Plat and Hb ≥1.5×10^9/L, >100×10^9/L and >11.0 g/dL, respectively or 50% improvement (of all the 3) over baseline value. nPR: participants who satisfied all of CR criteria except for BM, where LN could be identified. PD: a)≥50% increase in sum of the products of ≥2 lymph nodes or appearance of new lymph nodes/extranodal lesions, or b)≥50% increase in size of HSM; new appearance of palpable HM/SM, or c)≥50% increase in number of Lym, or d)Transformation to a more aggressive histology.|Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)|FAS population participants who achieved confirmed CR, PR or nPR.||days||95% Confidence Interval|Median
747969|NCT00532129|Secondary|Disease Free Survival (DFS) Time|DFS time was defined as interval (in days) from first tumor response of CR to date of first tumor response of PD, or date of death by any cause. Participants who experienced none of these events or who were lost to follow-up at the time of analysis were censored on last date when they were assessed for tumor response. CR: a) Absence of LD by PE and CT, b) No HM/SM by PE/CT, c) Absence of B symptoms, d) Normal CBC, and e) BM biopsy: normocellular for age, <30% of the cells being Lym and LN absent. PD: a) ≥50% increase in sum of the products of ≥2 lymph nodes compared to their smallest size or appearance of new lymph nodes/extranodal lesions, or b) ≥50% increase in the size of HSM; new appearance of palpable HM/SM, or c) ≥50% increase in the absolute number of circulating Lym to ≥5×10^9/L, or d) Transformation to a more aggressive histology.|Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)|FAS population participants who achieved confirmed CR.||days||95% Confidence Interval|Median
747970|NCT00532129|Secondary|Progression Free Survival (PFS) Time|PFS was defined as the interval (in days) from trial treatment start date to earlier of the date of first tumor response assessment of PD or date of death by any cause. Participants who experienced none of these events or who were lost to follow-up at the time of analysis were censored on last date when they were assessed for tumor response. PD is considered if 1 of the following criteria is met: a)≥50% increase in sum of products of ≥2 lymph nodes compared to their smallest size (at least one ≥2 cm in diameter) or appearance of new lymph nodes/extranodal lesions, b)≥50% increase in the size of HSM as determined by PE/CT; appearance of palpable HM/SM that was not previously present, c)≥50% increase in the number of circulating Lym to ≥5×10^9/L, d)Transformation to a more aggressive histology. Symptomatic deterioration (evident in clinical symptoms but not supported by tumor assessments), in such cases, the determination of clinical progression was based on symptomatic deterioration.|Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)|FAS.||days||95% Confidence Interval|Median
747971|NCT00532129|Secondary|Percentage of Participant With Disease Progression or Death|PD is considered if 1 of the following criteria is met: a)≥50% increase in sum of the products of ≥2 lymph nodes compared to their smallest size (at least one ≥2 cm in diameter) or appearance of new lymph nodes/extranodal lesions, b)≥50% increase in the size of HSM as determined by PE/CT scan; appearance of palpable HM/SM that was not previously present, c)≥50% increase in the absolute number of circulating Lym to ≥5×10^9/L, d)Transformation to a more aggressive histology. Symptomatic deterioration (evident in clinical symptoms but not supported by tumor assessments), in such cases, the determination of clinical progression was based on symptomatic deterioration.|Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)|FAS.||percentage of participants|||Number
747972|NCT00532129|Secondary|Percentage of Participants With Objective Response (CR or PR)|Objective response was defined as a tumor response of CR or PR. CR was achieved if all of the criteria were met for ≥8 weeks: a)Absence of LD by PE and CT scan, b)No HM/SM by PE/CT scan, c)Absence of B symptoms, d)Normal CBC, and e)BM biopsy: normocellular for age, <30% of the cells being Lym and LN absent. PR was achieved if all of the criteria were met: a)≥50% decrease in Lymp count from the baseline value, b)≥50% reduction in LD by CT scan, c)≥50% reduction in size of liver/spleen by PE/CT scan and at least 1 of the following for a minimum of 8 weeks: i. Leuk ≥1.5×10^9/L or 50% improvement over baseline, ii. Plat >100×10^9/L or 50% improvement over baseline and iii. Hb >11.0 g/dL or 50% improvement over baseline without transfusion. Participants who fulfilled criteria for CR with persistent anemia/thrombocytopenia were considered PRs.|Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)|FAS.||percentage of participants||95% Confidence Interval|Number
747973|NCT00532129|Secondary|Percentage of Participants With BOR of Stable Disease (SD)|Participants without CR/PR or PD were considered having a tumor response of SD. CR: a) Absence of LD by PE and CT, b) No HM/SM by PE/CT, c) Absence of B symptoms, d) Normal CBC, and e) BM biopsy: normocellular for age, <30% of the cells being Lym and LN absent. PR: a) ≥50% decrease in Lym count from baseline, b) ≥50% reduction in LD, c) ≥50% reduction in size of liver/spleen by PE/CT and ≥1 of the following for at least 8 weeks: i. Leuk ≥1.5×10^9/L or 50% improvement over baseline, ii. Plat >100×10^9/L or 50% improvement over baseline and iii. Hb >11.0 g/dL or 50% improvement over baseline without transfusion. PD: a) ≥50% increase in sum of the products of ≥2 lymph nodes compared to their smallest size or appearance of new lymph nodes/extranodal lesions, or b) ≥50% increase in the size of HSM; new appearance of palpable HM/SM, or c) ≥50% increase in the absolute number of circulating Lym to ≥5×10^9/L, or d) Transformation to a more aggressive histology.|Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)|FAS.||percentage of participants|||Number
747974|NCT00532129|Secondary|Percentage of Participants With BOR of Progressive Disease (PD)|PD is considered if 1 of the following criteria is met: a)≥50% increase in sum of the products of ≥2 lymph nodes compared to their smallest size (at least one ≥2 cm in diameter) or appearance of new lymph nodes/extranodal lesions, b)≥50% increase in the size of hepatosplenomegaly (HSM) as determined by PE/CT scan; appearance of palpable HM/SM that was not previously present, c)≥50% increase in the absolute number of circulating Lym to ≥5×10^9/L, d)Transformation to a more aggressive histology. Symptomatic deterioration (evident in clinical symptoms but not supported by tumor assessments), in such cases, the determination of clinical progression was based on symptomatic deterioration.|Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)|FAS.||percentage of participants|||Number
747975|NCT00532129|Secondary|Percentage of Participants With BOR of Nodular Partial Response (nPR)|CR was achieved if all of the following criteria were met for ≥8 weeks: a)Absence of LD by PE and CT scan, b)No HM/SM by PE/CT scan, c)Absence of B symptoms, d)Normal CBC, and e)BM biopsy: normocellular for age, <30% of the cells being Lym and LN absent. Participants with nPR were those who satisfied all of the CR criteria except for the BM, where LN could be identified histologically.|Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)|FAS.||percentage of participants|||Number
747976|NCT00532129|Secondary|Percentage of Participants With BOR of Partial Response (PR)|PR was achieved if all of the following criteria were met: a)≥50% decrease in Lym count from the baseline value, b)≥50% reduction in LD by CT scan, c)≥50% reduction in size of liver/spleen by PE/CT scan and at least 1 of the following for a minimum of 8 weeks: i. Leuk ≥1.5×10^9/L or 50% improvement over baseline, ii. Plat >100×10^9/L or 50% improvement over baseline and iii. Hb >11.0 g/dL or 50% improvement over baseline without transfusion. Participants who fulfilled criteria for CR with persistent anemia/thrombocytopenia were considered in PRs. CR was achieved if all of the criteria were fulfilled for ≥8 weeks: a)Absence of LD by PE and CT scan, b)No HM/SM by PE/CT, c)Absence of B symptoms, d)Normal CBC, and e)BM biopsy: normocellular for age, <30% of the cells being Lym and LN absent.|Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)|FAS.||percentage of participants|||Number
747977|NCT00532129|Secondary|Percentage of Participants With Best Overall Response (BOR) of Clinical CR or Confirmed CR|Clinical CR was achieved if all of the following criteria were met: a)Absence of lymphadenopathy (LD) by physical examination (PE) and Computed Tomography (CT) scan (all lymph nodes less than [<] 1.5 centimeters [cm] in diameter), b)No hepatomegaly (HM)/splenomegaly (SM) by PE/CT scan, c)Absence of B symptoms (unexplained fever greater than [>] 38 degrees [°] Centigrade [C], drenching night sweats/>10 percent [%] body weight loss in the last 6 months), d)Normal Complete Blood Count (CBC) (i. Leukocytes (Leuk) greater than or equal to [≥] 1.5×10^9 per liter (/L), ii. Platelets (Plat) >100×10^9/L, and iii. Haemoglobin (Hb) >11.0 grams per deciliter [g/dL]) and e)Once clinical, radiological and laboratory evaluations demonstrated CR, bone marrow (BM) biopsy and aspirate were performed 8 weeks later for confirmation; BM sample: normocellular for age, <30% of the cells being lymphocytes (Lym) and lymphoid nodules (LN) absent was considered as a confirmed CR.|Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)|FAS.||percentage of participants|||Number
747978|NCT00532129|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 56 days from the beginning of the last treatment cycle that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs as well as non-serious AEs.|First administration of study treatment up to 56 days after the beginning of the last treatment cycle (up to 365 days)|FAS.||percentage of participants|||Number
747979|NCT00532155|Secondary|Health Related Quality of Life (HRQL) Assessed by the Average Symptom Burden Index (ASBI)|HRQL assessments were performed by participants using a self-administered LCSS questionnaire. LCSS is a 9-item questionnaire, six measuring major symptoms for lung malignancies, and 3 summation items related to total symptomatic distress, activity status and overall quality of life. Participant responses were measured using visual analogue scales (VAS) with 100-mm lines. ABSI was the mean score for the six major lung cancer symptoms (appetite, fatigue, cough, dyspnea, hemoptysis and pain), each scored between 0 (for best outcome) to 100 (for worst outcome).|Baseline (prior to first dose), at cycles 2 and 4 and at the end of study therapy.|ITT population with questionnaires evaluable for ABSI.||units on a scale||Standard Deviation|Mean
747980|NCT00532155|Secondary|Health Related Quality of Life (HRQL) Assessed by the Lung Cancer Symptom Scale (LCSS)|HRQL assessments were performed by participants using a self-administered LCSS questionnaire. LCSS is a 9-item questionnaire, six measuring major symptoms for lung malignancies (appetite, fatigue, cough, dyspnea, hemoptysis and pain), and 3 summation items related to total symptomatic distress, activity status and overall quality of life. Participant responses were measured using visual analogue scales (VAS) with 100-mm lines. The LCSS total score was defined as the mean of the 9 items of the scale, each scored between 0 (for best outcome) to 100 (for worst outcome).|Baseline (prior to first dose), at cycles 2 and 4 and at the end of study therapy.|ITT population with questionnaires evaluable for LCSS.||units on a scale||Standard Deviation|Mean
747981|NCT00532155|Secondary|Overall Response (OR) Rate as Per Response Evaluation Criteria in Solid Tumours (RECIST) Criteria|"Participants with OR were those who had a confirmed complete response [CR] or a confirmed partial response [PR], based on RECIST criteria, in which
CR refected the disappearance of all tumor lesions (with no new tumors)
PR reflected a pre-defined decrease in tumor burden - a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD
OR was CR + PR The response rate was the percent of participants with a response.
To determine a response, tumors were assessed by the investigators using Computerized Tomography (CT) scans or Magnetic Resonance Imaging (MRI) scans; and an observed response was confirmed by repeated imaging after 4 – 6 weeks."|Baseline to data cut-off (26 January 2011)|Evaluable population: All ITT participants with measurable disease at study entry, and with at least one valid post baseline tumor evaluation, except if the participant died due to progressive disease or had documented (ie, radiological) progression before having any post-baseline tumor evaluation.||percentage of participants|||Number
747982|NCT00532155|Secondary|Progression Free Survival (PFS)|"PFS was defined as the time interval between the date of randomization and the time of occurrence of the first radiological tumor progression detected by a computer tomography (CT) scan and /or by Magnetic Resonance Imaging (MRI); or death due to any cause; whichever was earlier. Participants without disease progression were censored at the earliest date between their last valid tumour assessment and the data cutoff date.
PFS was estimated from Kaplan-Meier Curves."|Baseline to data cut-off (26 January 2011)|Intent to treat (ITT) population. The results are based on a total of 865 PFS events (434 in the placebo group and 431 in the aflibercept group) at the time of cutoff.||months|Participants|95% Confidence Interval|Median
747983|NCT00532155|Primary|Overall Survival (OS)|"OS was time interval from the date of randomization to the date of death due to any cause. If death was not observed during the study, overall survival time was censored at the last date the participant was known to be alive, or the study cutoff date, whichever was earlier. The cut-off date for the OS was date when 687 deaths were observed.
OS was estimated from Kaplan-Meier Curves."|Baseline to the date when 687 deaths occurred (26 January 2011)|All randomized participants.||months|Participants|95% Confidence Interval|Median
747984|NCT00532259|Secondary|Overall Survival||within 16 months following the first CT-011 treatment (18 months following autologous PBSCT).|||Percent||90% Confidence Interval|Number
747985|NCT00532259|Primary|Progression-free Survival|PFS (progression-free survival ) will be determined at the eligible patient populations|16 months following the first CT-011 administration (approximately 18 months following autologous PBSCT).|Patients who did not meet key study entry criteria were excluded from the eligible data set.||Percent||90% Confidence Interval|Number
747986|NCT00532298|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|During a 21-day follow-up period (Day 0-20) after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||Subjects|||Number
747987|NCT00532298|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs)|MSCs were defined as an AEs with a medically-attended visit (MAE) i.e. prompting emergency room (ER) visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. Any MSC was defined as at least one MSC experienced. Grade 3 was a MSC that prevented normal activities and related was defined as a MSC assessed by the investigator to be causally related to the study vaccination.|During a 21-day follow-up period (Day 0-20) after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||Subjects|||Number
747988|NCT00532298|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.|During a 21-day follow-up period (Day 0-20) after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||Subjects|||Number
747989|NCT00532298|Secondary|Duration of Solicited General AEs|Duration was defined as number of days with any grade of general symptoms.|During a 7-day follow-up period (Day 0-6) after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.||Days||Full Range|Median
747990|NCT00532298|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs|Any temperature was defined as oral temperature greater than or equal to 38.0 degree centigrade i.e ≥38.0°C, grade 3 temperature was oral temperature ≥39.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relation to vaccination and grade 3 was defined as a general symptom that prevented normal activity. Related was a general symptom assessed by the investigator as causally related to the study vaccination.|During a 7-day follow-up period (Day 0-6) after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.||Subjects|||Number
747991|NCT00532298|Secondary|Duration of Solicited Local AEs|Duration was defined as number of days with any grade of local symptoms.|During a 7-day follow-up period (Day 0-6) after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.||Days||Full Range|Median
747992|NCT00532298|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)|Grade 3 ecchymosis, redness and swelling was greater than 100 millimeter (mm) i.e. >100mm and grade 3 pain was considerable pain at rest that prevented normal everyday activities. Any was occurrence of any local symptom regardless of their intensity grade. Any for ecchymosis, redness and swelling was >20mm.|During a 7-day follow-up period (Day 0-6) after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.||Subjects|||Number
747993|NCT00532298|Secondary|The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations|A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. The vaccine strains included A/New Caledonia (for all groups receiving vaccine formulations for the Northern Hemisphere [NH] 2006/2007 influenza season) or A/Solomon Islands (for all groups receiving vaccine formulations for the NH 2007/2008 influenza season), A/Wisconsin and B/Malaysia antigens.|At Days 0 and 21|The analysis was performed on According-to-Protocol (ATP) immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity were available.||Subjects|||Number
747994|NCT00532298|Secondary|HI Antibody Seroconversion Factors|Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/New Caledonia (for all groups receiving vaccine formulations for the Northern Hemisphere [NH] 2006/2007 influenza season) or A/Solomon Islands (for all groups receiving vaccine formulations for the NH 2007/2008 influenza season), A/Wisconsin and B/Malaysia antigens.|At Day 21|The analysis was performed on According-to-Protocol (ATP) immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity were available.||fold increase||95% Confidence Interval|Geometric Mean
747995|NCT00532298|Secondary|The Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations|A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains included A/New Caledonia (for all groups receiving vaccine formulations for the Northern Hemisphere [NH] 2006/2007 influenza season) or A/Solomon Islands (for all groups receiving vaccine formulations for the NH 2007/2008 influenza season), A/Wisconsin and B/Malaysia antigens.|At Day 21|The analysis was performed on According-to-Protocol (ATP) immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity were available.||Subjects|||Number
747996|NCT00532298|Secondary|HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations|Antibody titers were expressed as GMTs. The vaccine strains included A/New Caledonia or A/Solomon Islands, A/Wisconsin and B/Malaysia antigens. A/New Caledonia vaccine strain was administered to all groups receiving the Northern Hemisphere 2006/2007 influenza season vaccine formulations. A/Solomon Islands vaccine strain was administered to all groups receiving the Northern Hemisphere 2007/2008 influenza season vaccine formulations. A/Wisconsin and B/Malaysia vaccine strains were administered to all groups.|At Days 0 and 21|The analysis was performed on According-to-Protocol (ATP) immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity were available.||titer||95% Confidence Interval|Geometric Mean
747997|NCT00532298|Primary|Haemagglutination Inhibition (HI) Antibody Titers for the H1N1 Vaccine Strain|Antibody titers were expressed as Geometric mean titers (GMTs). The H1N1 vaccine strains included A/New Caledonia and A/Solomon Islands antigens. A/New Caledonia vaccine strain was administered to both groups receiving the adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season. A/Solomon Islands vaccine strain was administered to both groups receiving the adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season.|At Days 0 and 21|The analysis was performed on According-to-Protocol (ATP) immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity were available. This primary outcome was assessed only on those groups receiving any of the GSK Bio's influenza vaccine GSK576389A formulations.||titer||95% Confidence Interval|Geometric Mean
747998|NCT00532441|Secondary|Overall Survival|Determine Overall Survival|18 Months|||months||95% Confidence Interval|Median
747999|NCT00532441|Secondary|Response Rate|Determine the Response Rate Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0)|18 months|||participants|||Number
748000|NCT00532441|Primary|16 Weeks Progression-free Survival|To determine the rate of progression-free survival (PFS) at 16 weeks for the combination therapy of erlotinib and docetaxel for subjects in the Biliary stratum, per RECIST criteria. Progressive disease is defined as at least a 20% increase in the sum of the longest diameter of target lesions taking as reference the smallest sum recorded since the treatment started or the appearance of one or more new lesions.|Start of treatment until disease progression per RECIST criteria up to 16 weeks|||months||95% Confidence Interval|Median
748001|NCT00532480|Primary|17-item Hamilton Depression Rating Scale|Standard 17-item rating scale for depression used in clinical trials. A score of 0-7 is considered to be normal. 8 - 13 mild depression. Scores of 20 or higher indicate moderate, severe, or very severe depression, and are usually required for entry into a clinical trial. Range of score: 0 - 50.|8 weeks|10 patients included in the study out of which 7 completed 8 weeks of the study||units on a scale||Standard Deviation|Mean
748003|NCT00532493|Secondary|Quality of Life Inventory (QOLI)|Change from baseline in possible range for QOLI is -6 to 6. Higher QOLI indicates better satisfaction with life.|This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination).|11 participants in the prazosin group have missing data on this item at one or more of the follow-up weeks; 9 participants in the placebo group have missing data at one or more of the follow-up weeks||scores on a scale||Standard Deviation|Mean
748004|NCT00532493|Secondary|SF-12 Mental Standardized Score (SF-12 MCS)|Change from baseline in possible range for SF-12 MCS is 5-76. Higher SF-12 score indicates better level of health.|This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination).|11 participants in the prazosin group have missing data on this item at one or more of the follow-up weeks; 9 participants in the placebo group have missing data at one or more of the follow-up weeks||scores on a scale||Standard Deviation|Mean
748005|NCT00532493|Secondary|SF-12 Physical Standardized Score (SF-12 PCS)|Change from baseline in possible range for SF-12 PCS is 6-72. Higher SF-12 score indicates better level of health.|This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination).|11 participants in the prazosin group have missing data on this item at one or more of the follow-up weeks; 9 participants in the placebo group have missing data at one or more of the follow-up weeks||scores on a scale||Standard Deviation|Mean
748006|NCT00532493|Secondary|Patient Health Questionnaire-9 (PHQ9)|Change from baseline in possible range for PHQ9 score is 0-27. Higher PHQ9 score indicates more severe depression.|This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination).|11 participants in the prazosin group have missing data on this item at one or more of the follow-up weeks; 9 participants in the placebo group have missing data at one or more of the follow-up weeks||scores on a scale||Standard Deviation|Mean
748007|NCT00532493|Secondary|PTSD Checklist-Military Version (PCL-M) Score|Change from baseline in possible range for PCL-M score 17-85. Higher PCL score indicates greater propensity for chronic and delayed PTSD.|This secondary outcome was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks to assess change in PTSD symptom severity.|11 participants in the prazosin group have missing data on this item at one or more of the follow-up weeks; 9 participants in the placebo group have missing data at one or more of the follow-up weeks||scores on a scale||Standard Deviation|Mean
748008|NCT00532493|Primary|Clinical Global Impression of Change (CGIC)|Change from baseline in possible range for Clinical Global Impression of Change 1-7. As compared to baseline global condition, 1 is marked improvement, 2 is moderate improvement, 3 is minimal improvement, 4 is no change, 5 is minimal worsening, 6 is moderate worsening, and 7 is marked worsening.|This primary outcome measure was administered at baseline and week 10. The change of the 10-week from baseline was reported.|17 participants in the prazosin group have missing data on this item at week 10; 16 participants in the placebo group have missing data on this item at week 10||scores on a scale||Standard Deviation|Mean
748009|NCT00532493|Secondary|Total CAPS Score|Change from baseline in possible range for CAPS total score is 0-136. Higher score indicates more severe PTSD symptoms.|The total CAPS was administered at baseline, 6, 10, 18, and 26 weeks (or early termination).|11 participants in the prazosin group have missing data on this item at one or more of the follow-up weeks; 9 participants in the placebo group have missing data at one or more of the follow-up weeks||scores on a scale||Standard Deviation|Mean
748010|NCT00532493|Secondary|Clinical Global Impression of Change|Change from baseline in possible range for Clinical Global Impression of Change (CGIC) 1-7. As compared to baseline global condition, 1 is marked improvement, 2 is moderate improvement, 3 is minimal improvement, 4 is no change, 5 is minimal worsening, 6 is moderate worsening, and 7 is marked worsening.|This secondary outcome measure was administered at 6, 10, 14, 18, 22 and 26 weeks (or early termination).|11 participants in the prazosin group have missing data on this item at one or more of the follow-up weeks; 9 participants in the placebo group have missing data at one or more of the follow-up weeks||scores on a scale||Standard Deviation|Mean
748011|NCT00532493|Secondary|CAPS Recurrent Distressing Dreams Item|Change from baseline in frequency and/or severity of combat trauma-related nightmares will be assessed by the CAPS Recurrent Distressing Dreams item. Possible range for Recurrent Distressing Dreams is 0-8. Higher score indicates more severe PTSD symptoms.|This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination) to assess temporal course of changes in symptoms in response to prazosin or placebo.|11 participants in the prazosin group have missing data on this item at one or more of the follow-up weeks; 9 participants in the placebo group have missing data at one or more of the follow-up weeks||scores on a scale||Standard Deviation|Mean
748012|NCT00532493|Secondary|Pittsburgh Sleep Quality Index|Change from baseline in possible range for PSQI global score 0-21. Higher PSQI score indicates worse quality of sleep.|This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination).|11 participants in the prazosin group have missing data on this item at one or more of the follow-up weeks; 9 participants in the placebo group have missing data at one or more of the follow-up weeks||scores on a scale||Standard Deviation|Mean
748013|NCT00532493|Primary|Pittsburgh Sleep Quality Index (PSQI)|Change from baseline in possible range for PSQI global score 0-21. Higher PSQI score indicates worse quality of sleep.|This primary outcome measure was administered at baseline and week 10. The change of the 10-week from baseline was reported.|17 participants in the prazosin group have missing data on this item at week 10; 16 participants in the placebo group have missing data on this item at week 10||scores on a scale||Standard Deviation|Mean
748014|NCT00532493|Primary|CAPS Recurrent Distressing Dreams Item|Change from baseline in frequency and/or severity of combat trauma-related nightmares will be assessed by the CAPS Recurrent Distressing Dreams item. Possible range for Recurrent Distressing Dreams is 0-8. Higher score indicates more severe PTSD symptoms.|This primary outcome measure was administered at baseline and week 10. The change of the 10-week from baseline was reported.|17 participants in the prazosin group have missing data on this item at week 10; 16 participants in the placebo group have missing data on this item at week 10||scores on a scale||Standard Deviation|Mean
748030|NCT00532779|Secondary|Body Weight- Proportion of Subjects With ≥10% Decrease||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||Percentage of participants||95% Confidence Interval|Number
748015|NCT00532779|Secondary|Change in Food Craving Inventory Carbohydrates Subscale Score|The Food Craving Inventory is a 33-item self-report measure designed to assess specific food cravings and is organized into 4 subscales (high fats, sweets, carbohydrates/starches, and fast-food fats). A craving was defined as an intense desire to consume a particular food (or food type) that was difficult to resist over the past month. Subjects rated their frequency of cravings for each of the 33 items using a 5-point scale, where 1=never, 2=rarely, 3=sometimes, 4=often, and 5=always. The carbohydrates subscale consisted of 8 items and the score ranges from 8 (better outcome) to 40 (worse outcome).|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||units on a scale||Standard Error|Least Squares Mean
748016|NCT00532779|Secondary|Change in Food Craving Inventory Sweets Subscale Score|The Food Craving Inventory is a 33-item self-report measure designed to assess specific food cravings and is organized into 4 subscales (high fats, sweets, carbohydrates/starches, and fast-food fats). A craving was defined as an intense desire to consume a particular food (or food type) that was difficult to resist over the past month. Subjects rated their frequency of cravings for each of the 33 items using a 5-point scale, where 1=never, 2=rarely, 3=sometimes, 4=often, and 5=always. The sweets subscale consisted of 8 items and the score ranges from 8 (better outcome) to 40 (worse outcome).|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||units on a scale||Standard Error|Least Squares Mean
748017|NCT00532779|Secondary|Change in IDS-SR Total Scores|IDS-SR= Inventory of Depressive Symptoms-Subject Rated IDS-SR total score is based on 30 items. The total score can range from 0-84, with 0 being no depressive symptoms and 84 being very severe depressive symptoms. A total score ≤ 13 indicates no depression.|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||units on a scale||Standard Error|Least Squares Mean
748018|NCT00532779|Secondary|Change in Diastolic Blood Pressure||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||mm Hg||Standard Error|Least Squares Mean
748019|NCT00532779|Secondary|Change in Systolic Blood Pressure||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||mm Hg||Standard Error|Least Squares Mean
748020|NCT00532779|Secondary|Change in Fasting LDL Cholesterol Levels||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||mg/dL||Standard Error|Least Squares Mean
748021|NCT00532779|Secondary|Change in Question 19 From 21-Item COE (Control of Eating) Questionnaire|Question 19: Generally, how difficult has it been to control your eating? Scoring: 0=not at all difficult; 100=extremely difficult|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||units on a scale||Standard Error|Least Squares Mean
748022|NCT00532779|Secondary|Change in HOMA-IR Levels, Using Log-transformed Data|HOMA-IR= Homeostasis Model Assessment-Insulin Resistance|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||percent change||95% Confidence Interval|Least Squares Mean
748023|NCT00532779|Secondary|Change in Fasting Blood Glucose Levels||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||mg/dL||Standard Error|Least Squares Mean
748024|NCT00532779|Secondary|Change in Fasting Insulin Levels, Using Log-transformed Data||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||percent change||95% Confidence Interval|Least Squares Mean
748025|NCT00532779|Secondary|Change in High-sensitivity C Reactive Protein (Hs-CRP) Levels, Using Log-transformed Data||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||percent change||95% Confidence Interval|Least Squares Mean
748026|NCT00532779|Secondary|Change in IWQOL-Lite Total Scores|IWQOL-Lite= Impact of Weight on Quality of Life-Lite Questionnaire Total score is based on a scale from 0 to 100, with 0 representing the poorest and 100 the best quality of life and where a score of 71-79 indicates moderate impairment|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||units on a scale||Standard Error|Least Squares Mean
748027|NCT00532779|Secondary|Change in Fasting Triglycerides Levels, Using Log-transformed Data||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||percent change||95% Confidence Interval|Least Squares Mean
748028|NCT00532779|Secondary|Change in Fasting HDL Cholesterol Levels||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||mg/dL||Standard Error|Least Squares Mean
748029|NCT00532779|Secondary|Change in Waist Circumference||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||cm||Standard Error|Least Squares Mean
749185|NCT00541658|Secondary|Percent Change From Baseline in Greater Trochanter BMD, Week 104 / Endpoint||Week 104 / Endpoint|ITT Population. Last Observation Carried Forward at Week 104.||Percent Change||95% Confidence Interval|Least Squares Mean
748032|NCT00532779|Primary|Co-primary: Body Weight- Mean Percent Change||Baseline, 56 weeks|Modified ITT (Full Analysis Set): Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||percentage of body weight||Standard Error|Least Squares Mean
748033|NCT00532883|Primary|Distribution of the Density of Hemoglobin SC Red Cells|An individuals’ percentage of red blood cells with density greater than 41 g/dL as measured by Advia.|measured 2 months after initiation of treatment|ITT: All randomized subjects who receive any clinical trial material. Subjects in the ITT population will be classified according to the treatment group to which they were randomized, regardless of what study drug they received.||percent of cells||Standard Deviation|Mean
748034|NCT00532935|Secondary|Percent of Participants With A1C <7.0% at Week 32||Week 32|The Full Analysis Set (FAS) included all patients who received at least one dose of double-blind study drug and had both a baseline value and ≥ 1 post-baseline value for this outcome. For FAS patients with no data at Week 32, the last non-baseline observed measurement was carried forward to Week 32.||Percent Participants|||Number
748035|NCT00532935|Secondary|Change From Baseline in FPG at Week 32|Change from baseline reflects the Week 32 FPG minus the baseline FPG|Baseline and Week 32|Full Analysis Set (FAS) included all patients who received at least one dose of double-blind study drug and had both a baseline value and ≥ 1 post-baseline value for this outcome. For FAS patients with no data at Week 32, the last non-baseline observed measurement was carried forward to Week 32.||mg/dL||95% Confidence Interval|Least Squares Mean
748036|NCT00532935|Secondary|Change From Baseline in 2-hour Post-Meal Glucose (PMG) at Week 32|Change from baseline reflects the Week 32 2-hour PMG minus the baseline 2-hour PMG|Baseline and Week 32|The Full Analysis Set (FAS) included all patients who received at least one dose of double-blind study drug and had both a baseline value and ≥ 1 post-baseline value for this outcome. For FAS patients with no data at Week 32, the last non-baseline observed measurement was carried forward to Week 32.||mg/dL||95% Confidence Interval|Least Squares Mean
748037|NCT00532935|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 1|Change from baseline reflects the Week 1 FPG minus the baseline FPG. At Week 1, the dose was 50/500 mg b.i.d. for Sita/Met FDC and 30 mg q.d. for pioglitazone|Baseline and Week 1|The Full Analysis Set (FAS) included all patients who received at least one dose of double-blind study drug and had both a baseline value and ≥ 1 post-baseline value for this outcome.||mg/dL||95% Confidence Interval|Least Squares Mean
748038|NCT00532935|Primary|Change From Baseline in A1C at Week 32|A1C is measured as a percent. Thus this change from baseline reflects the Week 32 A1C percent minus the baseline A1C percent|Baseline and Week 32|The Full Analysis Set (FAS) included all patients who received at least one dose of double-blind study drug and had both a baseline value and ≥ 1 post-baseline value for this outcome. For FAS patients with no data at Week 32, the last non-baseline observed measurement was carried forward to Week 32.||Percent of glycosylated hemoglobin (A1C)||95% Confidence Interval|Least Squares Mean
748039|NCT00532948|Secondary|Anti Tumor Activity|Tumor response refers to the best response prior to failure (disease progression, death or second malignancy).|Up to 6 years|Efficacy data of the present study (NO18517 - NCT00532948) were pre-specified to be combined with efficacy data of the Phase 2 portion of this Study, NO21125 (NCT01118377) for analysis. Results are currently posted in the record of Study NO21125.|||||
748040|NCT00532948|Secondary|The Area Under the Plasma Concentration-time Curve From Time of Dosing to the Last Measurable Concentration (AUClast) of Capecitabine and Its Metabolites (5’-DFCR, 5’-DFUR, 5-FU and FBAL)|AUC last concentration of capecitabine and its metabolites. Participants who consented to participating in the PK studies were randomized to either sampling series A or Series B. The collection time points included 2 different series, Series A (Baseline [pre-dose], 10 mins, 30 mins, 1, 2.5, 6, 8 and 10 hours after dosing) and Series B (Baseline [pre-dose], 15 minutes, 45 minutes, 1.5, 4, 8 and 10 hours after dosing).|Day 1 and Day 14|The safety population consisted of all eligible patients who received at least one dose of capecitabine. Participants available at a particular time point were included in analysis.||h*ng/mL||Standard Deviation|Mean
748041|NCT00532948|Secondary|Time to Maximum Plasma Concentration (Tmax) of Capecitabine and Its Metabolites (5’-DFCR, 5’-DFUR, 5-FU and FBAL)|Tmax is the corresponding time at which Cmax occurs of capecitabine and its metabolites.Participants who consented to participating in the PK studies were randomized to either sampling series A or Series B. The collection time points included 2 different series, Series A (Baseline [pre-dose], 10 mins, 30 mins, 1, 2.5, 6, 8 and 10 hours after dosing) and Series B (Baseline [pre-dose], 15 minutes, 45 minutes, 1.5, 4, 8 and 10 hours after dosing).|Day 1 and Day 14|The safety population consisted of all eligible patients who received at least one dose of capecitabine. Participants available at a particular time point were included in analysis.||Hour||Full Range|Median
748042|NCT00532948|Secondary|Maximum Observed Plasma Concentration (Cmax) of Capecitabine and Its Metabolites (5’-Deoxy-5-Fluorocytidine [5’-DFCR], 5’-Deoxy-5-Fluorouridine [5’-DFUR], 5-Fluorouracil [5-FU] and Alpha-fluoro-beta-alanine [FBAL])|The maximum observed plasma concentration of capecitabine and its metabolites. Participants who consented to participating in the PK studies were randomized to either sampling series A or Series B. The collection time points included 2 different series, Series A (Baseline [pre-dose], 10 mins, 30 mins, 1, 2.5, 6, 8 and 10 hours after dosing) and Series B (Baseline [pre-dose], 15 minutes, 45 minutes, 1.5, 4, 8 and 10 hours after dosing).|Day 1 and Day 14|The safety population consisted of all eligible patients who received at least one dose of capecitabine. Participants available at a particular time point were included in analysis.||ng/mL||Standard Deviation|Mean
748043|NCT00532948|Primary|Number of Participants With Baseline Shift From Normal to Low or High in Blood Chemistry Parameters|For blood chemistry, the parameters assessed were: Sodium, potassium, calcium, magnesium, chloride, bicarbonate, total protein, albumin, alkaline phosphatase, alanine transaminase (ALT), aspartate aminotransferase (AST), blood urea nitrogen (BUN), Lactate dehydrogenase (LDH), total bilirubin, direct bilirubin, indirect bilirubin, creatinine (serum creatinine or creatinine clearance), glucose.|Up to 06 years|The safety population consisted of all eligible patients who received at least one dose of capecitabine. Participants available at a particular time point were included in analysis.||Participants|||Number
748247|NCT00534495|Secondary|Number of Participants With Presence of Systemic Features ( Fever, Rash)||At Weeks 4, 12 and 24|At week 4 ,Rilonacept 36 and Placebo 34 participants , at week 12 , Rilonacept 33 and 29 Placebo participants , and at week 24 combined group with 57 participants, at baseline Rilonacept 36 and Placebo 35 participants.||participants|||Number
748044|NCT00532948|Primary|Number of Participants With Baseline Shift From Normal to Low or High in Hematology Parameters|For hematology, the parameters assessed were: Hemoglobin, hematocrit, platelet count, RBC, WBC, lymphocytes, monocytes,granulocytes (blasts), neutrophils(segs, bands),eosinophils and basophils.|Up to 06 years|The safety population consisted of all eligible patients who received at least one dose of capecitabine. Participants available at a particular time point were included in analysis.||Participants|||Number
748045|NCT00532948|Primary|Number of Participants With Adverse Events (AE)|An AE is an unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Toxicity was monitored and graded according to the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Adverse events that were not included in the CTCAEv3.0 were reported and graded under the other AE within the appropriate category.|Up to 06 years|The safety population consisted of all eligible patients who received at least one dose of capecitabine.||Participants|||Number
748046|NCT00532948|Primary|Dose Limiting Toxicities (DLTs)|DLT was defined as any of the following events occurring during the 11 week dose-finding period: any event that leads to interruption of planned radiation for 5 consecutive days or 10 days total; Grade 4 neutropenia or thrombocytopenia; Grade 3 thrombocytopenia that required a platelet transfusion on 2 or more occasions; any Grade 3 or 4 non-hematologic toxicity (with the exception of grade 3 nausea or vomiting of less than 5 days duration, Grade 3 transaminases that returned to baseline value within 7 days of study drug interruption and that did not recur upon re-challenge with study drug, and/or Grade 3 fever or infection of <5 days duration); Grade 2 non-hematologic toxicities that persisted for >7 days and required treatment interruption, or any other capecitabine-related adverse events that required need for dose reduction or permanent cessation of therapy, interruption of study drug for >7 days or recurred on re-challenge with capecitabine rapidly disintegrating tablets (RDTs).|Upto 11 weeks|The safety population consisted of all eligible patients who received at least one dose of capecitabine.||Participants|||Number
748047|NCT00532948|Primary|Maximum Tolerated Dose (MTD) of Capecitabine.|The MTD was the dose level at which six evaluable patients had been treated and at most one patient experienced a dose limiting toxicity (DLT) and the next highest dose level was too toxic. Dose escalation occurred if 0 out of 3 or at most 1 out of 6 patients experienced DLT while being treated at a dose level; otherwise the dose was declared unsafe and thus above the MTD.|Upto 11 weeks.|The safety population consisted of all eligible patients who received at least one dose of capecitabine.||milligrams|||Number
748048|NCT00533117|Primary|Suicide Attempts|Suicide attempt count total over the course of the 12 month treatment period (sum of 6 bimonthly assessments during the treatment phase)|Assessed bimonthly|"Data was *prespecified* to be collected for the Dialectical Behavior Therapy With or Without Fluoxetine and Supportive Therapy With or Without Fluoxetine Arm/Group combination, therefore the four original treatment conditions were collapsed into 2 study arms for analysis of the primary outcome measure"||suicide attempt|||Number
748049|NCT00533273|Secondary|Change From Baseline Range of Motion After the First Injection||30 days after first treatment to the primary joint||||||
748050|NCT00533273|Secondary|Percent Reduction From Baseline Contracture After the First Injection||30 days after first treatment to the primary joint||||||
748051|NCT00533273|Secondary|Clinical Improvement After the First Injection||30 days after first treatment to the primary joint||||||
748052|NCT00533273|Secondary|Clinical Success After the First Injection||30 days after first treatment to the primary joint||||||
748053|NCT00533273|Secondary|Time to First Achieve and Maintain Clinical Success After the Last Injection||First evaluation visit on which clinical success is achieved and maintained through the Day 30 evaluation of the primary joint||||||
748054|NCT00533273|Secondary|Change From Baseline Range of Motion After the Last Injection||30 days after last treatment to the primary joint||||||
748055|NCT00533273|Secondary|Percent Reduction From Baseline Contracture After the Last Injection||30 days after last treatment to the primary joint||||||
748056|NCT00533273|Secondary|Clinical Improvement After the Last Injection||30 days after last treatment to the primary joint||||||
748057|NCT00533273|Primary|Reduction in Contracture to 5° or Less of the Primary Joint|"The Primary Outcome Measure for patients treated with AA4500 is the percentage of 45 joints that were successfully treated where successfully treated was defined as reduction in contracture to 5° or less.
The Primary Outcome Measure for placebo treated patients is the percentage of 21 joints that were successfully treated where successfully treated was defined as reduction in contracture to 5° or less."|Within 30 days after the last injection|Intent-to-Treat population||% Joints|||Number
748058|NCT00533351|Primary|Change From Baseline in Daily Pain Score at Week 2|Change from baseline in the daily-average-pain score at week 2. This was measured using a 11-point (0 to 10) scale where 0 represented no pain and 10 represented worst pain. Due to the low number of patients completing the treatment period of the study no analyses were performed|Baseline, Week 2|Due to low number of patients completing the treatment period of the study no analyses were performed|||||
748059|NCT00533351|Secondary|Change From Baseline in Subject Global Impression of Change Score at Week 2|Change from baseline in Subject Global Impression of Change score at week 2. The Subject Global Impression of Change is a self-evaluation by the subject of their overall change in relief of neuropathic pain since the beginning of the study rated on a 7-point scale (1=very much improved to 7=very much worse). Due to low number of patients completing the treatment period of the study no analyses were performed.|Baseline, Week 2|Due to low number of patients completing the treatment period of the study no analyses were performed.|||||
748060|NCT00533442|Secondary|Overall Pancreas Transplant Function at 12, 36, and 60 Months Post-transplant.|Comparisons of pancreas function (C-peptide in ng/mL) at 12, 36, and 60 months post-transplant.|at 1-5 years post-transplant|Number analyzed here includes all patients alive with a functioning graft that had an available measurement taken at that time||ng/mL||Standard Error|Mean
748061|NCT00533442|Secondary|Overall Kidney Transplant Function at 12, 36, and 60 Months Post-transplant.|Comparisons of renal function (eGFR, measured in mL/min/1.73 m^2) at 12, 36, and 60 months post-transplant.|at 1-5 years post-transplant|Number analyzed here includes all patients alive with a functioning graft that had an available measurement taken at that time||mL/min/1.73m^2||Standard Error|Mean
749186|NCT00541658|Secondary|Percent Change From Baseline in Greater Trochanter BMD, Week 104, ITT Population||Week 104|ITT Population.||Percent Change||95% Confidence Interval|Least Squares Mean
748062|NCT00533442|Primary|Event-Specific Survival Comparisons|Freedom from biopsy-proven acute rejection of the kidney allograft; Freedom from biopsy-proven acute rejection of the pancreas allograft; Death-censored kidney graft survival; Death-censored pancreas graft survival; Death-uncensored graft (kidney and pancreas) survival; and Patient survival.|over 1-10 years post-transplant|||Participants|||Count of Participants
748063|NCT00533507|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|Up to one month after the third dose|||subjects|||Number
748064|NCT00533507|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product|During the 31-day (Day 0-30) period after each dose|||subjects|||Number
748065|NCT00533507|Secondary|Number of Subjects Reporting Solicited Symptoms|Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include diarrhoea, drowsiness, fever, irritability, loss of appetite, and vomiting|During the 4-day (Day 0-3) period after each dose|||subjects|||Number
748066|NCT00533507|Secondary|Number of Subjects With Anti-rotavirus Immunoglobulin A Antibody Concentrations Above the Cut-Off Value|Anti-rotavirus IgA antibody cut-off value assessed was greater than or equal to 20 Units per milliliter (U/mL).|Four months after the administration of the second dose of Rotarix™ vaccine|Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results||subjects|||Number
748067|NCT00533507|Secondary|Number of Subjects With Anti-Poliovirus 1, 2 and 3 Antibody Titers Above the Cut-Off Value|Anti-poliovirus 1, 2 and 3 antibody cut-off value assessed was greater than or equal to 1:8 titer.|One month after the third dose|Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results||subjects|||Number
748068|NCT00533507|Primary|Concentration of Anti-Pneumococcal Antibodies|"Concentrations are given as geometric mean titers (GMC) and expressed in microgram per milliliter (µg/mL).
The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F."|One month after the third dose|Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results||µg/mL||95% Confidence Interval|Geometric Mean
748069|NCT00533507|Secondary|Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-Off Value|Anti-HBs antibody cut-off value assessed was greater than or equal to 10 milli-International Units per milliliter (mIU/mL).|One month after the third dose|Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results||subjects|||Number
748070|NCT00533507|Secondary|Number of Subjects With Anti-Pertussis (PT), Anti-Filamentous Hemagglutinin (FHA) and Anti-Pertactin (PRN) Antibody Concentrations Above the Cut-Off Value|Anti-PT, anti-FHA and anti-PRN cut-off values assessed were greater than or equal to 5 Enzyme-Linked Immuno Sorbent Assay (ELISA) units per milliliter (EL.U/mL).|One month after the third dose|Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results||subjects|||Number
748071|NCT00533507|Secondary|Number of Subjects With Anti-Diphteria and Anti-Tetanus Toxoids Antibody Concentrations Above the Cut-Off Value|Anti-diphteria and anti-tetanus toxoids antibody cut-off values assessed were greater than or equal to 0.10 International Units per milliliter (IU/mL).|One month after the third dose|Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results||subjects|||Number
748072|NCT00533507|Secondary|Number of Subjects With Anti-Polyribosyl-Ribitol Phosphate Antibody Concentrations Above the Cut-Off Value|Anti-polyribosyl-ribitol phosphate antibody cut-off value assessed was greater than or equal to 0.15 microgram per milliliter (μg/mL).|One month after the third dose|Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results||subjects|||Number
748073|NCT00533507|Secondary|Number of Subjects With Opsonophagocytic Activity Against Cross-Reactive Pneumococcal Serotypes Above the Cut-Off Value|Cut-off value for opsonophagocytic activity against pneumococcal antibody assessed was greater than or equal to 1:8 titer.|One month after the third dose|Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results||subjects|||Number
748074|NCT00533507|Secondary|Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-Off Value|Cut-off value for opsonophagocytic activity against pneumococcal antibody assessed was greater than or equal to 1:8 titer.|One month after the third dose|Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results||subjects|||Number
748075|NCT00533507|Secondary|Number of Subjects With Cross-Reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value|Anti-pneumococcal antibody cut-off value assessed was 0.05 microgram per milliliter (µg/mL).|One month after the third dose|Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results||subjects|||Number
748076|NCT00533507|Secondary|Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value|"Anti-pneumococcal antibody cut-off value assessed was 0.05 microgram per milliliter (μg/mL).
The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F."|Before the first dose (pre) and one month after (post) the third dose|Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results||subjects|||Number
748077|NCT00533507|Primary|Concentration of Anti-Protein D Antibodies|Concentrations are given as geometric mean concentrations (GMC) and expressed in Enzyme-Linked Immuno Sorbent Assay (ELISA) units per milliliter (EL.U/mL).|One month after the third dose|Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results||EL.U/mL||95% Confidence Interval|Geometric Mean
748078|NCT00533507|Secondary|Number of Subjects With Anti-Protein D Antibody Concentrations Above the Cut-Off Value|Anti-protein D antibody cut-off value assessed was greater than or equal to 100 Enzyme-Linked Immuno Sorbent Assay (ELISA) units per milliliter (EL.U/mL).|Before the first dose (pre) and one month after (post) the third dose|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available results||subjects|||Number
749187|NCT00541658|Secondary|Percent Change From Baseline in Greater Trochanter BMD, Week 52 / Endpoint||Week 52 / Endpoint|ITT Population. Last Observation Carried Forward at Week 52.||Percent Change||95% Confidence Interval|Least Squares Mean
748079|NCT00533546|Secondary|National Institutes of Health Stroke Scale (NIHSS)|"The NIHSS is a measure of neurologic deficit on a scale of 0-42, with 0 being normal. The National Institutes of Health Stroke Scale, or NIH Stroke Scale (NIHSS) is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0. The 11 items are:
Level of Consciousness Horizontal Eye Movement Visual field test Facial Palsy Motor Arm Motor Leg Limb Ataxia Sensory Language Speech Extinction and Inattention"|90 days|||units on a scale||Standard Deviation|Mean
748080|NCT00533546|Secondary|Mean Barthel Index Score|"Measure of functional recovery using Barthel Index (range 0-100). The Barthel scale or Barthel ADL index is an ordinal scale used to measure performance in activities of daily living (ADL). Each performance item is rated on this scale with a given number of points assigned to each level or ranking. It uses ten variables describing ADL and mobility with 10 points given to each variable for a total of 100 points. A higher number is associated with a greater likelihood of being able to live at home with a degree of independence following discharge from hospital. The ten variables addressed in the Barthel scale are:
presence or absence of fecal incontinence presence or absence of urinary incontinence help needed with grooming help needed with toilet use help needed with feeding help needed with transfers (e.g. from chair to bed) help needed with walking help needed with dressing help needed with climbing stairs and help needed with bathing"|90 days|||units on a scale||Standard Deviation|Mean
748081|NCT00533546|Secondary|Mean Modified Rankin Scale Score|"Measure of disability as determined by categorical assignment on modified Rankin Scale.. The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.
The scale runs from 0-6, running from perfect health without symptoms to death.
0 - No symptoms.
- No significant disability. Able to carry out all usual activities, despite some symptoms.
- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
- Moderate disability. Requires some help, but able to walk unassisted.
- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
- Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
- Dead."|90 days|||units on a scale||Standard Deviation|Mean
748082|NCT00533546|Primary|Number of Participants With Intracranial Hemorrhage|"Intracranial Hemorrhage (ICH):
Fatal ICH: Death ascribed to ICH confirmed by autopsy or CT imaging. Major non-fatal ICH: Hemorrhage within brain parenchyma associated with neurological deterioration or evidence of subdural, epidural or intraventricular hemorrhage on CT imaging, with or without symptoms.
Symptomatic ICH: Hemorrhage within the territory of qualifying infarction with neurological deterioration as measured by > 2 point increase in the National Institutes of Health Stroke Scale (NIHSS) from previous examination; hemorrhage in different vascular territory associated with new neurologic deficit. All symptomatic ICH will be defined as a major ICH.
Asymptomatic ICH: Presence of hemorrhage within the territory of qualifying infarction without neurological deterioration ascribed to the hemorrhage or presence of hemorrhage within brain parenchyma outside the territory of qualifying infarction without new neurologic deficit (would not be considered a major ICH)"|Measured within 36-48 hours of treatment|All participants enrolled were analyzed.||participants|||Number
748083|NCT00533702|Secondary|Maximum Concentration (Cmax) for Cycle 1 Day 14|Cmax was not calculated due to sparse sampling.|Cycle 1 Day 14 (21-day cycle)|Zero participants were analyzed.|||||
748084|NCT00533702|Secondary|Maximum Concentration (Cmax) for Cycle 1 Day 7|Cmax was not calculated due to sparse sampling.|Cycle 1 Day 7 (21-day cycle)|Zero participants were analyzed.|||||
748085|NCT00533702|Secondary|Maximum Concentration (Cmax) for Cycle 1 Day 1|Cmax was not calculated due to sparse sampling.|Cycle 1 Day 1 (21-day cycle) 1-hour post infusion|Zero participants were analyzed.|||||
748086|NCT00533702|Secondary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Response Rate) at 12 Weeks|Response rate was defined as a CR or a PR using Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR was defined as the disappearance of all target and non-target lesions and the normalization of non-target lesion tumor marker levels. PR was defined as at least a 30% decrease from baseline in sum of longest diameter of target lesions. CR and PR had to be confirmed by repeat assessments and performed no fewer than 4 weeks after the criteria for response were first met.|12 weeks (4 cycles of treatment)|Intent-to-Treat Population: All enrolled participants who were treated with any quantity of study drug.||percentage of participants|||Number
748087|NCT00533702|Secondary|Percentage of Participants With Stable Disease (SD) or Better (Disease Control Rate) at 12 Weeks|Disease Control Rate (DCR) was defined as complete response (CR) plus partial response (PR) plus SD using Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR was defined as the disappearance of all target and non-target lesions and the normalization of non-target lesion tumor marker levels. PR was defined as at least a 30% decrease from baseline in sum of longest diameter of target lesions. CR and PR had to be confirmed by repeat assessments and performed no fewer than 4 weeks after the criteria for response were first met. Stable Disease (SD) was defined as: neither sufficient increase to qualify for progressive disease (PD) nor sufficient shrinkage to qualify for PR, taking as reference the smallest sum of the longest diameters recorded since treatment began. PD was defined as at least 20% increase in sum of longest diameter of target lesions.|12 weeks (4 cycles of treatment)|Intent-to-Treat Population: All enrolled participants who were treated with any quantity of study drug.||percentage of participants|||Number
748096|NCT00533897|Secondary|LTE: Mean Seated Systolic Blood Pressure (SBP) During LTE|During LTE, blood pressure was taken in participants while seated, measured in millimeters of mercury (mmHg) and were assessed at all office visits prior to SC injection of abatacept. Vital signs were also assessed 7 days after the last injection of abatacept for participants who were withdrawn prematurely.|Days 337, 365, 449, 533, 617, 729,813, 897,981, 1093, 1177,1261,1345, 1457,1541,1625,1709,1821,1905,1989,2073|Participants who received at least 1 dose of study medication in LTE period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point.||mm Hg||Standard Deviation|Mean
749188|NCT00541658|Secondary|Percent Change From Baseline in Greater Trochanter BMD, Week 52, ITT Population||Week 52|ITT Population.||Percent Change||95% Confidence Interval|Least Squares Mean
748088|NCT00533702|Secondary|Percentage of Participants With Stable Disease (SD) or Better (Disease Control Rate) at 6 Weeks|Disease Control Rate (DCR) was defined as complete response (CR) plus partial response (PR) plus SD using Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR was defined as the disappearance of all target and non-target lesions and the normalization of non-target lesion tumor marker levels. PR was defined as at least a 30% decrease from baseline in sum of longest diameter of target lesions. CR and PR had to be confirmed by repeat assessments and performed no fewer than 4 weeks after the criteria for response were first met. SD was defined as: neither sufficient increase to qualify for progressive disease (PD) nor sufficient shrinkage to qualify for PR, taking as reference the smallest sum of the longest diameters recorded since treatment began. PD was defined as at least 20% increase in sum of longest diameter of target lesions.|6 weeks (2 cycles of treatment)|Intent-to-Treat Population: All enrolled participants who were treated with any quantity of study drug.||percentage of participants|||Number
748089|NCT00533702|Secondary|Duration of Response|The duration of overall response was defined as the time from first assessment of complete response (CR) or partial response (PR) to the first date of progressive disease (PD) using Response Evaluation Criteria in Solid Tumors (RECIST v1.0), initiation of other or additional antitumor therapy, or death from any cause. CR was defined as the disappearance of all target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions. CR and PR had to be confirmed by repeat assessments and performed no fewer than 4 weeks after the criteria for response were first met. PD was defined as at least 20% increase in sum of longest diameter of target lesions. Participants who did not relapse were censored at the day of their last objective tumor assessment.|Cycle 1 Day 1 (of 21-day cycle) up to 17.1 months|Intent-to-Treat Population: All enrolled participants who were treated with any quantity of study drug and who had CR or PR. Censored participants: IMC-1121B (ramucirumab) + dacarbazine=2; IMC-1121B (ramucirumab)=0.||months||95% Confidence Interval|Median
748090|NCT00533702|Secondary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)]|The ORR was defined as the percentage of all randomized participants with the best overall response of PR or CR using Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR was defined as the disappearance of all target and non-target lesions. PR was defined as at least a 30% decrease in sum of longest diameter of target lesions. CR and PR had to be confirmed by repeat assessments and performed no fewer than 4 weeks after the criteria for response were first met.|Cycle 1 Day 1 (of 21-day cycle) up to 17.1 months|Intent-to-Treat Population: All enrolled participants who were treated with any quantity of study drug.||percentage of participants||95% Confidence Interval|Number
748091|NCT00533702|Secondary|Number of Participants With Adverse Events (AE)|The number of participants who experienced any IMC-1121B (ramucirumab [RAM]) treatment-related and treatment emergent AE (TEAE), treatment-related TEAE of Grade ≥3, treatment-related TE serious AEs (SAEs), treatment-related TEAE resulting in death (Grade 5 AE) and any TEAEs resulting in death. A summary of SAEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.|Baseline up to 40 months|Safety Population: All enrolled participants who were treated with any quantity of study drug.||participants|||Number
748092|NCT00533702|Primary|Progression Free Survival (PFS)|PFS was defined as the time from the first day of therapy to the first evidence of disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.0) or death from any cause. Progressive disease (PD) was defined as at least a 20% increase in the sum of the longest diameter (LD) of the target lesions, taking as reference the smallest sum LD recorded since the treatment started in comparison with the measurement of the nadir or the appearance of 1 or more new lesions. In addition, unequivocal progression of existing non-target lesions was considered PD. New or existing pleural effusion/ascites required cytological confirmation for PD according to the protocol. Participants who did not progress and who were alive or did not have documented progression or missed ≥2 visits, or had no post baseline assessment were censored at the day of their last tumor assessment.|Baseline up to 36 months|Intent-to-Treat Population: All enrolled participants who were treated with any quantity of study drug. Censored participants: IMC-1121B (ramucirumab) + dacarbazine=9; IMC-1121B (ramucirumab)=4.||months||95% Confidence Interval|Median
748093|NCT00533897|Secondary|LTE: Mean Temperature (T) During LTE|During LTE, temperature was taken in participants while seated, measured in degrees celsius and was assessed at all office visits prior to SC injection of abatacept. Temperature was also assessed 7 days after the last injection of abatacept for participants who were withdrawn prematurely.|Days 337, 365, 449,533, 617, 729,813, 897,981, 1093, 1177,1261, 1345, 1457,1541,1625,1709,1821,1905,1989,2073|Participants who received at least 1 dose of study medication in LTE period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point.||degrees Celsius||Standard Deviation|Mean
748094|NCT00533897|Secondary|LTE: Mean Heart Rate (HR) During LTE|During LTE, heart rate was taken in participants while seated, measured in beats per minute (bpm) and was assessed at all office visits prior to SC injection of abatacept. Heart rate was also assessed 7 days after the last injection of abatacept for participants who were withdrawn prematurely.|Days 337, 365, 449, 533, 617, 729,813, 897,981, 1093, 1177,1261, 1345, 1457,1541,1625,1709,1821,1905,1989,2073|Participants who received at least 1 dose of study medication in LTE period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point.||bpm||Standard Deviation|Mean
748095|NCT00533897|Secondary|LTE: Mean Seated Diastolic Blood Pressure (DBP) During LTE|During LTE, blood pressure was taken in participants while seated, measured in millimeters of mercury (mmHg) and were assessed at all office visits prior to SC injection of abatacept. Vital signs were also assessed 7 days after the last injection of abatacept for participants who were withdrawn prematurely.|Days 337, 365, 449, 533, 617, 729,813, 897,981, 1093, 1177,1261, 1345, 1457,1541,1625,1709,1821,1905,1989,2073|Participants who received at least 1 dose of study medication in LTE period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point.||mmHg||Standard Deviation|Mean
748120|NCT00533897|Secondary|DBW Period; Mean Temperature (T) During Period II|Participants were seated and temperature taken just prior to study drug injection.|Days 113, 141, and 169|Participants who received at least 1 dose of study medication in DBW period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point.||degrees Celsius||Standard Deviation|Mean
749189|NCT00541658|Secondary|Percent Change From Baseline Greater Trochanter BMD, Week 26, ITT Population||Week 26|ITT Population.||Percent Change||95% Confidence Interval|Least Squares Mean
748097|NCT00533897|Secondary|LTE: Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria During LTE|MA criteria: serum glucose (Glu): <65 mg/dL/>220 mg/dL;fasting serum Glu: <0.8* LLN/>1.5*ULN,or if BL<LLN then use 0.8*BL or >ULN,or if BL>ULN then use >2.0*BL or <LLN;total protein: <0.9*LLN/>1.1*ULN,or if BL<LLN then use <0.9*BL or >UNL,or if BL>UNL then use >1.1*BL or <LLN; albumin: <0.9*LLN,or if BL<LLN then use <0.75 BL;uric acid: >1.5*ULN,or if BL>ULN then use >2*BL. Urinalysis (Urine protein,urine Glu,urine blood,leukocyte esterase,Red Blood Cells [RBCs], White Blood Cells [WBCs]):Use ≥2 when BL value missing or when pre-dose=0 or 0.5; use ≥3 when pre-dose=1, use ≥4 when pre-dose=2 or 3|For Period I non-responders: as of Day 85 and up to completion of LTE (FEB 2014). For ST completers: as of Day 253 and up to completion of LTE (FEB 2014). Data included up to 56 days post last dose.|Participants who received at least 1 dose of study medication in LTE period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available during the LTE period.||participants|||Number
748098|NCT00533897|Secondary|LTE: Number of Participants With Electrolyte Values Meeting the Marked Abnormality Criteria During LTE|Marked abnormality criteria: Sodium (Na): <0.95*LLN/ >1.05*ULN, or if BL<LLN then use <0.95* BL or >ULN, or if BL>ULN then use>1.05* BL or <LLN; potassium (K): <0.9* LLN/>1.1*ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; (Cl): <0.9* LLN/>1.1* ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; calcium (Ca): <0.8* LLN/>1.2* ULN, or if BL<LLN then use <0.75* BL or >ULN, or if BL>ULN then use>1.25* BL or <LLN; phosphorous (P): <0.75* LLN/ >1.25* ULN, or if BL<LLN then use 0.67* BL or >ULN, or if BL>ULN then use>1.33* BL or <LLN|For Period I non-responders: as of Day 85 and up to completion of LTE (FEB 2014). For ST completers: as of Day 253 and up to completion of LTE (FEB 2014). Data included up to 56 days post last dose.|Participants who received at least 1 dose of study medication in LTE period and who had data available during the LTE period.||participants|||Number
748099|NCT00533897|Secondary|LTE: Number of Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria During LTE|Marked abnormality criteria: Alkaline phosphatase (ALP): >2* ULN, or if BL>ULN then use >3* BL; aspartate aminotransferase (AST): >3* ULN, or if BL>ULN then use >4* BL; alanine aminotransferase (ALT): >3* ULN, or if BL>ULN then use >4* BL; G-Glutamyl transferase (GGT): >2* ULN, or if BL>ULN then use >3* BL; Bilirubin: >2* ULN, or if BL>ULN then use >4* BL; blood urea nitrogen (BUN): >2* BL; creatinine: >1.5* BL|For Period I non-responders: as of Day 85 and up to completion of LTE (FEB 2014). For ST completers: as of Day 253 and up to completion of LTE (FEB 2014). Data included up to 56 days post last dose.|Participants who received at least 1 dose of study medication in LTE period and who had data available during the LTE period.||participants|||Number
748100|NCT00533897|Secondary|LTE: Number of Participants With Hematology Values Meeting the Marked Abnormality Criteria During LTE|Marked abnormality criteria are: Hemoglobin (HGB): >3 g/dL decrease from BL; Hematocrit: <0.75 * BL; Erythrocytes: <0.75 * BL; Platelets (PLT): <0.67 * LLN/>1.5 * ULN, or if BL < LLN then use <0.5 * BL and <100,000 mm^3; Leukocytes: <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL or >ULN, or if BL>ULN then use >1.2 * BL or <LLN; neutrophils+bands: <1.0 * 10^3 cells/uL; eosinophils: >0.750 * 10^3 cells/uL; basophils: > 400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750 * 10^3 cells/uL/ >7.50 * 10^3 cells/uL.|For Period I non-responders: as of Day 85 and up to completion of LTE (FEB 2014). For ST completers: as of Day 253 and up to completion of LTE (FEB 2014). Data included up to 56 days post last dose.|Participants who received at least 1 dose of study medication in LTE period and who had data available during the LTE period.||participants|||Number
748101|NCT00533897|Secondary|LTE: Number of Participants With AEs of Special Interest During LTE|AEs of special interest in LTE are those AEs that may be associated with the use of immunomodulatory drugs, including all infections and opportunistic infections; autoimmune disorders; malignancies, local injection site reaction (pre-specified AEs occurring at the site of SC injection) and systemic injection site reactions (pre-specified systemic AEs such as hypersensitivity reactions occurring within 24 hours of SC injection)|For Period I non-responders: as of Day 85 and up to completion of LTE (FEB 2014) up to 56 days post last dose. For ST completers: as of Day 253 and up to completion of LTE (FEB 2014) up to 56 days post last dose.|Participants who received at least 1 dose of study medication in LTE period||participants|||Number
748102|NCT00533897|Secondary|LTE: Number of Participants With Death, Related SAEs, SAEs Leading to Discontinuation, Related AEs, or AEs Leading to Discontinuation During Long Term Extension (LTE)|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. SAEs include hospitalizations for elective surgical procedures.All deaths reported during the LTE including those that occurred > 56 days after the last dose. Related AE or SAE defined as AE or SAE with Certain, Probable, Possible, or Missing relationship to study medication. All participants who completed the ST period could enter the open label LTE on Day 253; LI Period 1 non-responders could directly enter the LTE.|For Period I non-responders: as of Day 85 and up to completion of LTE (FEB 2014), up to 56 days post last dose. For ST completers: as of Day 253 and up to completion of LTE (FEB 2014) up to 56 days post last dose.|Participants who received at least 1 dose of study medication in LTE period||participants|||Number
748103|NCT00533897|Secondary|LTE: Overall Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses (ECL Method) for On-Treatment Visits, Post Last Dose Visits, and Overall Study - All Participants Treated in LTE|Serum samples from Abatacept-treated adult participants with active RA were screened for the presence of drug-specific antibodies using electrochemiluminescence (ECL). The percent of participants with a positive abatacept induced immunogenicity response against cytotoxic T-lymphocyte antigen 4 (CTLA4) and possibly immunoglobulin (Ig), or against Ig and/or Junction Region was calculated by number of participants with a positive response divided by number of participants evaluated. Overall for on-treatment includes treatment visits on Days 337, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1177, 1261, 1457, 1625, 1821, and 1989.|Days 337, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1177, 1261, 1457, 1625, 1821, 1989 and 28, 56, 85, 168 days post last dose in LTE|All participants treated in LTE period with at least 1 immunogenicity result (ECL) during LTE period. n=number of participants evaluated.||percentage of participants|||Number
758418|NCT00617240|Primary|Change From Baseline to Week 24 in Weight|Change in weight is calculated as 24 weeks weight minus the baseline weight.|24 weeks|||kg||Standard Error|Mean
748104|NCT00533897|Secondary|LTE: Percent of Participants With HAQ Response Over Time - All Participants Treated in LTE|The disability section of the full HAQ includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Higher scores= greater dysfunction. A disability index (DI) was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ DI. Percent=number of participants with HAQ response divided by number of participants in the analysis. Since Period I Non-responders proceeded directly to the LTE at the end of Period I (Day 85), study days do not represent treatment days.|Study Days 1 (Baseline),15, 29, 57, 78, 85, 253, 337, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1177, 1261, 1345, 1457, 1541,1625,1709,1821,1905,1989, 2073|The LTE Treated Population contained those participants who received at least 1 dose of study medication during the LTE. Participants in LTE either completed Period 3 or were non-responders at the end of Period 1. n= number of participants with data who were evaluated||percentage of participants||95% Confidence Interval|Number
748105|NCT00533897|Secondary|LTE: Percent of Participants With Low Disease Activity in Long Term Extension: All Participants Treated in LTE|DAS28:continuous disease measure composite of 4 variables: number of tender joints out of 28 joints, number of swollen joints out of 28 joints, level of the serum reactant protein CRP, and participant global assessment of disease activity measure on a visual analogue scale. Low disease activity score: ≤ 3.2. Percent=Number of participants with Low Disease Activity divided by number of participants evaluated. Last day of ST is Day 85 for Period I Nonresponders and Day 253 for ST Completers . Data are not available(NA) for the period from Day 113 to Day 253 for Period 1 non-responders. Note: Day 85 and Day 337 assessments for the Period I Nonresponder cohort in fact represent consecutive assessments with an interval of approximately 1 month. For Period I nonresponder, study days do not represent treatment days. Study Day 337 for a Period I nonresponder actually corresponds to that participant’s Treatment Day 169.|For Period 1 non-responders: as of Study Day 85 and up to Day 1821. For ST completers: as of Study Day 253 and up to Day 1821.|The LTE Treated Population contained those participants who received at least 1 dose of study medication during the LTE. Participants in LTE either completed Period 3 or were nonresponders at the end of Period 1.||percentage of participants|||Number
748106|NCT00533897|Secondary|LTE: Percent of Participants Who Achieved Clinical Remission in the Long Term Extension - All Participants Treated in LTE|DAS28=continuous disease measure composite of 4 variables: number of tender joints out of 28, number of swollen joints out of 28, level of serum reactant protein CRP, and participant global assessment of disease activity measured on a visual analogue scale. Clinical remission=DAS28-CRP score<2.6. Percent=Number of participants meeting remission divided by number of participants evaluated. Last day of ST is Day 85 for Period I Nonresponders and Day 253 for ST Completers . Data are not available (NA) for the period from Day 113 to Day 253 for Period 1 non-responders. Note: Day 85 and Day 337 assessments for the Period I Nonresponder cohort in fact represent consecutive assessments with an interval of approximately 1 month. For Period I nonresponder, study days do not represent treatment days. Study Day 337 for a Period I nonresponder actually corresponds to that participant’s Treatment Day 169.|For Period I non-responders: as of Study Day 85 and up to Study Day 1821. For ST completers: as of Study Day 253 and up to Study Day 1821|The LTE Treated Population contained those participants who received at least 1 dose of study medication during the LTE. Participants in LTE either completed Period 3 or were nonresponders at the end of Period 1. n= number of participants evaluated at each specific timepoint||percentage of participants|||Number
748107|NCT00533897|Secondary|LTE: DAS28-CRP Mean Change From Baseline (Day 1) Over Time - All Participants Treated in LTE|DAS28=continuous disease measure composite of 4 variables: number of tender joints out of 28, number of swollen joints out of 28, level of serum reactant protein CRP, and participant global assessment of disease activity measured on a visual analogue scale. DAS28-CRP has numeric thresholds defining high disease activity (> 5.1), low disease activity (≤ 3.2) and remission (< 2.6). Last day of ST is Day 85 for Period I Nonresponders and Day 253 for ST Completers . Data are not available(NA) for the period from Day 113 to Day 253 for Period 1 non-responders. Note: Day 85 and Day 337 assessments for the Period I Nonresponder cohort in fact represent consecutive assessments with an interval of approximately 1 month. For Period I nonresponder, study days do not represent treatment days. Study Day 337 for a Period I nonresponder actually corresponds to that participant’s Treatment Day 169.|For Period 1 non-responders: as of Study Day 85 and up to Day 1821. For ST completers: as of Study Day 253 and up to Day 1821.|The LTE Treated Population contained those participants who received at least 1 dose of study medication during the LTE. Participants in LTE either completed Period 3 or were nonresponders at the end of Period 1. n=number of participants with both baseline and post-baseline measurements.||units on a scale||Standard Error|Mean
748108|NCT00533897|Secondary|ST; Number of Participants Positive for Anti-nuclear Antibody (ANA), Anti-double Stranded DNA Antibody (dsDNA), or Rheumatoid Factor (RF) at Day 253 According to Baseline Status (Negative at Baseline or Positive at Baseline) by DBW Treatment Groups|Venous blood was collected and tested for anti-nuclear antibodies, anti-dsDNA antibodies, and rheumatoid factor. ANA were detected by means of immunofluorescent antibodies. An anti-DNA radioimmunoassay was used for detection of anti-dsDNA antibodies (Diagnostic Products Corporation). RF was measured by an immunoturbidimetric assay (Roche Tina-Quant). Determinations of antibody or RF status were made at baseline and Day 253.|Baseline, Day 253|Participants treated in DBW period with at least 1 immunogenicity result (immunofluorescence, radioimmunoassay, or immunoturbidimetry) during this period. N=Number of Participants Analyzed, n=number of participants with data for that time point||participants|||Number
748109|NCT00533897|Secondary|Short Term; Abatacept Serum Concentration by Immunogenicity Status as Measured by ECL by RI Treatment Groups|Pharmacokinetics is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. Cmin=minimum observed plasma concentration of single-dose abatacept. Cmin for each participant was listed by study visit and immunogenicity status (seropositive vs. seronegative) was determined by ECL.|Day 197 through Day 253|Participants treated in RI period with at least 1 immunogenicity result (ECL) during RI period. N=Number of Participants Analyzed, n=number of participants with data for that time point||ug/mL||Standard Deviation|Mean
749190|NCT00541658|Secondary|Percent Change From Baseline in Femoral Neck BMD, Week 104 / Endpoint, ITT Population||Week 104 / Endpoint|ITT Population. LOCF at Week 104.||Percent Change||95% Confidence Interval|Least Squares Mean
748110|NCT00533897|Secondary|Short Term; Abatacept Serum Concentration by Immunogenicity Status as Measured by ELISA by RI Treatment Groups|Pharmacokinetics is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. Cmin=minimum observed plasma concentration of single-dose abatacept. Cmin for each participant was listed by study visit and immunogenicity status (seropositive vs. seronegative) was determined by ELISA.|Day 197 through Day 253|Participants treated during the RI Period with at least 1 immunogenicity result (ELISA) during this period. N=Number of Participants Analyzed, n=number of participants with data for that time point||ug/mL||Standard Deviation|Mean
748111|NCT00533897|Secondary|RI Period; Mean Temperature (T) During Period III||Days 169, 197, 225, and 253|Participants who received at least 1 dose of study medication in RI period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point.||degrees Celsius||Standard Deviation|Mean
748112|NCT00533897|Secondary|RI Period; Mean Heart Rate (HR) During Period III||Days 169, 197, 225, and 253|Participants who received at least 1 dose of study medication in RI period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point.||beats per minute (bpm)||Standard Deviation|Mean
748113|NCT00533897|Secondary|RI Period; Mean Seated Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) During Period III||Days 169, 197, 225, and 253|Participants who received at least 1 dose of study medication in RI period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point.||mm mercury (Hg)||Standard Deviation|Mean
748114|NCT00533897|Secondary|RI; Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria|MA criteria: serum glucose (Glu): <65 mg/dL/>220 mg/dL;fasting serum Glu: <0.8* LLN/>1.5*ULN,or if BL<LLN then use 0.8*BL or >ULN,or if BL>ULN then use >2.0*BL or <LLN;total protein: <0.9*LLN/>1.1*ULN,or if BL<LLN then use <0.9*BL or >UNL,or if BL>UNL then use >1.1*BL or <LLN; albumin: <0.9*LLN,or if BL<LLN then use <0.75 BL;uric acid: >1.5*ULN,or if BL>ULN then use >2*BL. Urinalysis (Urine protein,urine Glu,urine blood,leukocyte esterase,Red Blood Cells [RBCs], White Blood Cells [WBCs]):Use ≥2 when BL value missing or when pre-dose=0 or 0.5; use ≥3 when pre-dose=1, use ≥4 when pre-dose=2 or 3|From Day 169 through Day 253, up to 56 days post last dose in RI Period or up to first dose in LTE, whichever occurred earlier.|Participants who received at least 1 dose of study medication in RI period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available during the RI period.||participants|||Number
748115|NCT00533897|Secondary|RI; Number of Participants With Electrolytes Values Meeting the Marked Abnormality Criteria|Marked abnormality criteria: Sodium (Na): <0.95*LLN/ >1.05*ULN, or if BL<LLN then use <0.95* BL or >ULN, or if BL>ULN then use>1.05* BL or <LLN; potassium (K): <0.9* LLN/>1.1*ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; (Cl): <0.9* LLN/>1.1* ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; calcium (Ca): <0.8* LLN/>1.2* ULN, or if BL<LLN then use <0.75* BL or >ULN, or if BL>ULN then use>1.25* BL or <LLN; phosphorous (P): <0.75* LLN/ >1.25* ULN, or if BL<LLN then use 0.67* BL or >ULN, or if BL>ULN then use>1.33* BL or <LLN|From Day 169 through Day 253, up to 56 days post last dose in RI Period or up to first dose in LTE, whichever occurred earlier.|Participants who received at least 1 dose of study medication in RI period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available during the RI period.||participants|||Number
748116|NCT00533897|Secondary|RI; Number of Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria|Marked abnormality criteria: Alkaline phosphatase (ALP): >2* ULN, or if BL>ULN then use >3* BL; aspartate aminotransferase (AST): >3* ULN, or if BL>ULN then use >4* BL; alanine aminotransferase (ALT): >3* ULN, or if BL>ULN then use >4* BL; G-Glutamyl transferase (GGT): >2* ULN, or if BL>ULN then use >3* BL; Bilirubin: >2* ULN, or if BL>ULN then use >4* BL; blood urea nitrogen (BUN): >2* BL; creatinine: >1.5* BL|From Day 169 through Day 253, up to 56 days post last dose in RI Period or up to first dose in LTE, whichever occurred earlier.|Participants who received at least 1 dose of study medication in RI period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available during the RI period.||participants|||Number
748117|NCT00533897|Secondary|RI; Number of Participants With Hematology Values Meeting the Marked Abnormality Criteria|Marked abnormality criteria are: Hemoglobin (HGB): >3 g/dL decrease from BL; Hematocrit: <0.75 * BL; Erythrocytes: <0.75 * BL; Platelets (PLT): <0.67 * LLN/>1.5 * ULN, or if BL < LLN then use <0.5 * BL and <100,000 mm^3; Leukocytes: <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL or >ULN, or if BL>ULN then use >1.2 * BL or <LLN; neutrophils+bands: <1.0 * 10^3 cells/uL; eosinophils: >0.750 * 10^3 cells/uL; basophils: > 400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750 * 10^3 cells/uL/ >7.50 * 10^3 cells/uL.|From Day 169 through Day 253, up to 56 days post last dose in RI Period or up to first dose in LTE, whichever occurred earlier.|Participants who received at least 1 dose of study medication in RI period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available during the RI period.||participants|||Number
748118|NCT00533897|Secondary|RI; Number of Participants With AEs of Special Interest|AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections and opportunistic infections; autoimmune disorders; malignancies; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion), peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion),local injection site reaction (pre-specified AEs occurring at the site of SC injection)and systemic injection site reactions (pre-specified systemic AEs such as hypersensitivity reactions occurring within 24 hours of SC injection)|From Day 169 through Day 253, up to 56 days post last dose in RI Period or up to first dose in LTE, whichever occurred earlier.|Participants who received at least 1 dose of study medication in RI period.||participants|||Number
748119|NCT00533897|Secondary|RI; Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, or AEs Leading to Discontinuation|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|From Day 169 through Day 253, up to 56 days post last dose in RI Period or up to first dose in LTE, whichever occurred earlier.|Participants who received at least 1 dose of study medication in RI period.||participants|||Number
748121|NCT00533897|Secondary|DBW Period; Mean Heart Rate (HR) During Period 2|Heart Rate was taken in participants while seated, just prior to study drug injection, and measured in beats per minute (bpm)|Days 113, 141, and 169|Participants who received at least 1 dose of study medication in DBW period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point.||beats per minute (bpm)||Standard Deviation|Mean
748122|NCT00533897|Secondary|DBW; Mean Seated Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) During Double Blind Period|Blood pressures were taken in participants while seated, just prior to study drug injection, and measured in millimeters of mercury (mmHg).|Days 113, 141, and 169|Participants who received at least 1 dose of study medication in DBW period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point.||mm mercury (Hg)||Standard Deviation|Mean
748123|NCT00533897|Secondary|DBW; Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria|MA criteria: serum glucose (Glu): <65 mg/dL/>220 mg/dL;fasting serum Glu: <0.8* LLN/>1.5*ULN,or if BL<LLN then use 0.8*BL or >ULN,or if BL>ULN then use >2.0*BL or <LLN;total protein: <0.9*LLN/>1.1*ULN,or if BL<LLN then use <0.9*BL or >UNL,or if BL>UNL then use >1.1*BL or <LLN; albumin: <0.9*LLN,or if BL<LLN then use <0.75 BL;uric acid: >1.5*ULN,or if BL>ULN then use >2*BL. Urinalysis (Urine protein,urine Glu,urine blood,leukocyte esterase,Red Blood Cells [RBCs], White Blood Cells [WBCs]):Use ≥2 when BL value missing or when pre-dose=0 or 0.5; use ≥3 when pre-dose=1, use ≥4 when pre-dose=2 or 3|From Day 85 through Day 169, up to 56 days post last dose in DBW Period or up to first dose in RI Period, whichever occurred earlier|Participants who received at least 1 dose of study medication in DBW period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available during the DBW period.||participants|||Number
748124|NCT00533897|Secondary|DBW; Number of Participants With Electrolytes Values Meeting the Marked Abnormality Criteria|Marked abnormality criteria: Sodium (Na): <0.95*LLN/ >1.05*ULN, or if BL<LLN then use <0.95* BL or >ULN, or if BL>ULN then use>1.05* BL or <LLN; potassium (K): <0.9* LLN/>1.1*ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; (Cl): <0.9* LLN/>1.1* ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; calcium (Ca): <0.8* LLN/>1.2* ULN, or if BL<LLN then use <0.75* BL or >ULN, or if BL>ULN then use>1.25* BL or <LLN; phosphorous (P): <0.75* LLN/ >1.25* ULN, or if BL<LLN then use 0.67* BL or >ULN, or if BL>ULN then use>1.33* BL or <LLN|From Day 85 through Day 169, up to 56 days post last dose in DBW Period or up to first dose in RI Period, whichever occurred earlier|Participants who received at least 1 dose of study medication in DBW period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available during the DBW period.||participants|||Number
748125|NCT00533897|Secondary|DBW; Number of Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria|Marked abnormality criteria: Alkaline phosphatase (ALP): >2* ULN, or if BL>ULN then use >3* BL; aspartate aminotransferase (AST): >3* ULN, or if BL>ULN then use >4* BL; alanine aminotransferase (ALT): >3* ULN, or if BL>ULN then use >4* BL; G-Glutamyl transferase (GGT): >2* ULN, or if BL>ULN then use >3* BL; Bilirubin: >2* ULN, or if BL>ULN then use >4* BL; blood urea nitrogen (BUN): >2* BL; creatinine: >1.5* BL|From Day 85 through Day 169, up to 56 days post last dose in DBW Period or up to first dose in RI Period, whichever occurred earlier|Participants who received at least 1 dose of study medication in DBW period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available during the DBW period.||participants|||Number
748126|NCT00533897|Secondary|DBW; Number of Participants With Hematology Values Meeting the Marked Abnormality Criteria|Marked abnormality criteria are: Hemoglobin (HGB): >3 g/dL decrease from BL; Hematocrit: <0.75 * BL; Erythrocytes: <0.75 * BL; Platelets (PLT): <0.67 * LLN/>1.5 * ULN, or if BL < LLN then use <0.5 * BL and <100,000 mm^3; Leukocytes: <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL or >ULN, or if BL>ULN then use >1.2 * BL or <LLN; neutrophils+bands: <1.0 * 10^3 cells/uL; eosinophils: >0.750 * 10^3 cells/uL; basophils: > 400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750 * 10^3 cells/uL/ >7.50 * 10^3 cells/uL.|From Day 85 through Day 169, up to 56 days post last dose in DBW Period or up to first dose in RI Period, whichever occurred earlier|Participants who received at least 1 dose of study medication in DBW period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available during the DBW period.||participants|||Number
748127|NCT00533897|Secondary|DBW; Number of Participants With AEs of Special Interest|AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections and opportunistic infections; autoimmune disorders; malignancies; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion), peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion),local injection site reaction (pre-specified AEs occurring at the site of SC injection)and systemic injection site reactions (pre-specified systemic AEs such as hypersensitivity reactions occurring within 24 hours of SC injection)|From Day 85 through Day 169, up to 56 days post last dose in DBW Period or up to first dose in RI Period, whichever occurred earlier|Participants who received at least 1 dose of study medication in DBW period||participants|||Number
748128|NCT00533897|Secondary|DBW; Number of Participants With Death, Serious SAEs, Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, or AEs Leading to Discontinuation|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|From Day 85 through Day 169, up to 56 days post last dose in DBW Period or up to first dose in RI Period, whichever occurred earlier|Participants who received at least 1 dose of study medication in DBW period||participants|||Number
748129|NCT00533897|Secondary|LI Period; Mean Temperature (T)|Temperature was taken in participants while seated and measured in degrees celsius. Temperature was assessed at screening, at baseline on Day 1 prior to infusion of IV abatacept, at 30 and 60 minutes after IV infusion of abatacept on Day 1, and at all office visits prior to SC injection of abatacept. Temperature was also assessed 7 days after the last injection of abatacept for participants who were withdrawn prematurely.|Days 1, 15, 29, 57, 78, and 85|Participants who received at least 1 dose of study medication during LI period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point during the LI period.||degrees Celsius||Standard Deviation|Mean
748130|NCT00533897|Secondary|LI Period; Mean Heart Rate (HR)|Heart rate was taken in participants while seated and measured in beats per minute (bpm). Heart rate was assessed at screening, at baseline on Day 1 prior to infusion of IV abatacept, at 30 and 60 minutes after IV infusion of abatacept on Day 1, and at all office visits prior to SC injection of abatacept. Heart rate was also assessed 7 days after the last injection of abatacept for participants who were withdrawn prematurely.|Days 1, 15, 29, 57, 78, and 85|Participants who received at least 1 dose of study medication during LI period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point during the LI period.||bpm||Standard Deviation|Mean
748131|NCT00533897|Secondary|LI Period; Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Blood pressure was taken in participants while seated and measured in millimeters of mercury (mmHg). Pressures were assessed at screening, at baseline on Day 1 prior to infusion of IV abatacept, at 30 and 60 minutes after IV infusion of abatacept on Day 1, and at all office visits prior to SC injection of abatacept. Vital signs were also assessed 7 days after the last injection of abatacept for participants who were withdrawn prematurely.|Days 1, 15, 29, 57, 78, and 85|Participants who received at least 1 dose of study medication during LI period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point during the LI period.||mmHg||Standard Deviation|Mean
748132|NCT00533897|Secondary|LI; Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria|MA criteria: serum glucose (Glu): <65 mg/dL/>220 mg/dL;fasting serum Glu: <0.8* LLN/>1.5*upper limits of normal (ULN),or if BL< lower limits of normal (LLN) then use 0.8*BL or > upper limits of normal (ULN),or if BL>ULN then use >2.0*BL or <LLN;total protein: <0.9*LLN/>1.1*ULN,or if BL<LLN then use <0.9*BL or >ULN,or if BL>UNL then use >1.1*BL or <LLN; albumin: <0.9*LLN,or if BL<LLN then use <0.75 BL;uric acid: >1.5*ULN,or if BL>ULN then use >2*BL. Urinalysis: Urine protein,urine Glu,urine blood,leukocyte esterase,Red Blood Cells (RBCs), White Blood Cells (WBCs):Use ≥2 when BL value missing or when pre-dose=0 or 0.5; use ≥3 when pre-dose=1, use ≥4 when pre-dose=2 or 3|From Day 1 through Day 85, up to 56 days post last dose in Lead-in Period or up to first dose in next period, whichever occurred earlier|Participants who received at least 1 dose of study medication during LI period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available during LI period.||participants|||Number
748133|NCT00533897|Secondary|LI; Number of Participants With Electrolyte Values Meeting the Marked Abnormality Criteria|Marked abnormality criteria: Sodium (Na): <0.95*LLN/ >1.05*ULN, or if BL<LLN then use <0.95* BL or >ULN, or if BL>ULN then use>1.05* BL or <LLN; potassium (K): <0.9* LLN/>1.1*ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; (Cl): <0.9* LLN/>1.1* ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; calcium (Ca): <0.8* LLN/>1.2* ULN, or if BL<LLN then use <0.75* BL or >ULN, or if BL>ULN then use>1.25* BL or <LLN; phosphorous (P): <0.75* LLN/ >1.25* ULN, or if BL<LLN then use 0.67* BL or >ULN, or if BL>ULN then use>1.33* BL or <LLN|From Day 1 through Day 85, up to 56 days post last dose in Lead-in Period or up to first dose in next period, whichever occurred earlier|Participants who received at least 1 dose of study medication during LI period.||participants|||Number
748134|NCT00533897|Secondary|LI; Number of Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria|Marked abnormality criteria: Alkaline phosphatase (ALP): >2* ULN, or if BL>ULN then use >3* BL; aspartate aminotransferase (AST): >3* ULN, or if BL>ULN then use >4* BL; alanine aminotransferase (ALT): >3* ULN, or if BL>ULN then use >4* BL; G-Glutamyl transferase (GGT): >2* ULN, or if BL>ULN then use >3* BL; Bilirubin: >2* ULN, or if BL>ULN then use >4* BL; blood urea nitrogen (BUN): >2* BL; creatinine: >1.5* BL|From Day 1 through Day 85, up to 56 days post last dose in Lead-in Period or up to first dose in next period, whichever occurred earlier|Participants who received at least 1 dose of study medication during LI period.||participants|||Number
748135|NCT00533897|Secondary|LI; Number of Participants With Hematology Values Meeting the Marked Abnormality (MA) Criteria|Upper Normal Limit (ULN), Lower Normal Limit (LLN), Baseline (BL). Marked abnormality criteria are: Hemoglobin (HGB): >3 g/dL decrease from BL; Hematocrit: <0.75 * BL; Erythrocytes: <0.75 * BL; Platelets (PLT): <0.67 * LLN/>1.5 * ULN, or if BL < LLN then use <0.5 * BL and <100,000 mm^3; Leukocytes: <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL or >ULN, or if BL>ULN then use >1.2 * BL or <LLN; neutrophils+bands: <1.0 * 10^3 cells/ microliter (uL); eosinophils: >0.750 * 10^3 cells/uL; basophils: > 400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750 * 10^3 cells/uL/ >7.50 * 10^3 cells/uL.|From Day 1 through Day 85, up to 56 days post last dose in Lead-in Period or up to first dose in next period, whichever occurred earlier|Participants who received at least 1 dose of study medication during LI period.||participants|||Number
748136|NCT00533897|Secondary|LI Period; Number of Participants With AEs of Special Interest|AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections and opportunistic infections; autoimmune disorders; malignancies; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion), peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion),local injection site reaction (pre-specified AEs occurring at the site of SC injection)and systemic injection site reactions (pre-specified systemic AEs such as hypersensitivity reactions occurring within 24 hours of SC injection)|From Day 1 through Day 85, up to 56 days post last dose in Lead-in Period or up to first dose in next period, whichever occurred earlier|Participants who received at least 1 dose of study medication during LI period||participants|||Number
748137|NCT00533897|Secondary|LI; Number of Participants With Deaths, Serious Adverse Events (SAEs), SAEs Leading to Discontinuation, Adverse Events (AEs), Related AEs, or AEs Leading to Discontinuation|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|From Day 1 through Day 85, up to 56 days post last dose in Lead-in Period or up to first dose in next period, whichever occurred earlier|Participants who received at least 1 dose of study medication during LI period||participants|||Number
748295|NCT00528411|Secondary|Cardiopulmonary Parameters at Post 6-week Treatment: FVC|FVC is measured by Spirometry, the unit is Liter.|6-week post treatment|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.||Liter||Standard Deviation|Mean
748138|NCT00533897|Secondary|RI Period; Mean Change in DAS 28 (CRP) From RI Period Baseline (Day 169) Over Time|DAS28 is a continuous disease measure composite of 4 variables: the number of tender joints out of 28 joints, the number of swollen joints out of 28 joints, the level of the serum reactant protein CRP, and participant global assessment of disease activity measure on a visual analogue scale. DAS28 has numeric thresholds defining high disease activity (> 5.1), low disease activity (≤ 3.2) and remission (< 2.6). Clinically meaningful improvement= decrease in DAS28 score of ≥1.2 from baseline.|Days 169 (Period III Baseline), 197, 225, and 253|Participants who received at least 1 dose of study medication during RI period. N=Number of Participants Analyzed, n=number of participants with data for that time point and at RI period baseline.||units on a scale||Standard Error|Mean
748139|NCT00533897|Secondary|DBW Period; Percentage of Participants With Rheumatoid Arthritis (RA) Flare Over Time|"A participant had an RA flare if at least 2 of the following criteria were met:
Doubling of tender and swollen joint count from Day 78
Increase in DAS28-CRP score ≥ 1.2 from Day 78
Prematurely discontinued from Double-blind Withdrawal Period (Period 2) and continued to Re-introduction Period (Period 3)"|Days 85, 113, 141, and 169|Intent To Treat Analysis Population (DBW Period, Participants randomized in DBW period who received at least 1 dose of study medication in DBW period). N=Number of Participants Analyzed, n=number of participants with data for that time point.||percentage of participants|||Number
748140|NCT00533897|Secondary|DBW Period; Mean Change in DAS 28 (CRP) From DBW Period Baseline (Day 85) Over Time|DAS28 is a continuous disease measure composite of 4 variables: the number of tender joints out of 28 joints, the number of swollen joints out of 28 joints, the level of the serum reactant protein CRP, and participant global assessment of disease activity measure on a visual analogue scale. DAS28 has numeric thresholds defining high disease activity (> 5.1), low disease activity (≤ 3.2) and remission (< 2.6). Clinically meaningful improvement= decrease in DAS28 score of ≥1.2 from baseline.|Days 85 (Period 2 Baseline), 113, 141, and 169|Intent To Treat Analysis Population (DBW Period, Participants randomized in DBW period who received at least 1 dose of study medication in DBW period). N=Number of Participants Analyzed, n=number of participants with data for that time point and at DBW period baseline.||units on a scale||Standard Error|Mean
748141|NCT00533897|Secondary|LI; Percentage of Participants With Clinically Meaningful Improvement in DAS (CRP) Over Time|DAS28 is a continuous disease measure composite of 4 variables: the number of tender joints out of 28 joints, the number of swollen joints out of 28 joints, the level of the serum reactant protein CRP, and participant global assessment of disease activity measure on a visual analogue scale. DAS28 has numeric thresholds defining high disease activity (> 5.1), low disease activity (≤ 3.2) and remission (< 2.6). Clinically meaningful improvement= decrease in DAS28 score of ≥1.2 from baseline.|Days 15, 29, 57, 78, 85|Participants who received at least 1 dose of study medication during LI period. N=Number of Participants Analyzed, n=number of participants with data for that time point and at baseline.||percentage of participants|||Number
748142|NCT00533897|Secondary|LI; Mean Change in DAS 28 (CRP) From Baseline Over Time|DAS28 is a continuous disease measure composite of 4 variables: the number of tender joints out of 28 joints, the number of swollen joints out of 28 joints, the level of the serum reactant protein CRP, and participant global assessment of disease activity measure on a visual analogue scale. DAS28 has numeric thresholds defining high disease activity (> 5.1), low disease activity (≤ 3.2) and remission (< 2.6). Clinically meaningful improvement= decrease in DAS28 score of ≥1.2 from baseline.|Days 1 (Baseline), 15, 29, 57, 78, 85|Participants who received at least 1 dose of study medication during LI period. N=Number of Participants Analyzed, n=number of participants with data for that time point and at baseline.||units on a scale||Standard Error|Mean
748143|NCT00533897|Secondary|Short Term; Percentage of Participants With HAQ-DI Response Over Time by DBW Treatment Groups|The disability section of the full HAQ includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Higher scores= greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ disability Index.|Days 1 (Baseline),15, 29, 57, 78, 85, 113, 141, 169, 197, 225, and 253 (short term)|Intent To Treat Analysis Population (DBW Period, Participants randomized in DBW period who received at least 1 dose of study medication in DBW period). N=Number of Participants Analyzed, n=number of participants with data for that time point and at baseline.||percentage of Participants|||Number
748144|NCT00533897|Secondary|Short Term; Mean Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline Over Time by DBW Treatment Groups|The disability section of the full HAQ includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Higher scores= greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ disability Index.|Days 1 (Baseline),15, 29, 57, 78, 85, 113, 141, 169, 197, 225, and 253 (short term)|Intent To Treat Analysis Population (DBW Period, Participants randomized in DBW period who received at least 1 dose of study medication in DBW period). N=Number of Participants Analyzed, n=number of participants with data for that time point and at baseline.||units on a scale||Standard Error|Mean
748145|NCT00533897|Secondary|Short Term: Percentage of Participants Achieving Clinically Meaningful Improvement (CMI) in DAS 28 (CRP), Low Disease Activity (LDAS), or Clinical Remission Over Time by DBW Treatment Groups|DAS28 is a continuous disease measure composite of 4 variables: the number of tender joints out of 28 joints, the number of swollen joints out of 28 joints, the level of the serum reactant protein CRP, and participant global assessment of disease activity measure on a visual analogue scale. DAS28 has numeric thresholds defining high disease activity (> 5.1), low disease activity (≤ 3.2) and remission (< 2.6). Clinically meaningful improvement= decrease in DAS28 score of ≥1.2 from baseline.|Days 85, 169, and 253 (short term)|Intent To Treat Analysis Population (DBW Period, Participants randomized in DBW period who received at least 1 dose of study medication in DBW period). N=Number of Participants Analyzed, n=number of participants with data for that time point and, when relevant, at baseline.||percentage of participants|||Number
748321|NCT00528424|Secondary|Change From Baseline Range of Motion After the Last Injection||30 days after last treatment||||||
748146|NCT00533897|Secondary|Short Term: Mean Change in Disease Activity Score (DAS) 28 (Using C-Reactive Protein [CRP]) From Baseline Over Time by DBW Treatment Groups|The DAS28 is a continuous disease measure composite of 4 variables: the number of tender joints out of 28 joints, the number of swollen joints out of 28 joints, the level of the serum reactant protein CRP, and participant global assessment of disease activity measure on a visual analogue scale. DAS28 has numeric thresholds defining high disease activity (> 5.1), low disease activity (≤ 3.2) and remission (< 2.6). Clinically meaningful improvement= decrease in DAS28 score of ≥1.2 from baseline.|Days 1 (Baseline),15, 29, 57, 78, 85, 113, 141, 169, 197, 225, and 253 (short term)|Intent To Treat Analysis Population (DBW Period, Participants randomized in DBW period who received at least 1 dose of study medication in DBW period). N=Number of Participants Analyzed, n=number of participants with data for that time point and at baseline.||units on a scale||Standard Error|Mean
748147|NCT00533897|Secondary|Short Term: Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 ECL Antibody Responses by DBW Treatment Groups|ECL screened sera for drug-specific antibodies; immunocompetition was used to identify specific anti-Abatacept reactivity. Cytotoxic leukocyte antigen 4 (CTLA4) and Possibly Immunoglobulin (Ig) Category=reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction (JNC) Category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing or negative.|For on-TRT visits: Days 1-253 (ST). For follow-up post visits for participants who discontinued drug in the ST: Day 22 after last dose of ST drug to Day 85 after last dose of ST drug|All participants treated in DBW period with at least 1 immunogenicity result (ECL) during the Short Term. N=Number of Participants Analyzed, n=number of participants with data for that time point.||percentage of Participants|||Number
748148|NCT00533897|Secondary|Short Term (ST); Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 ELISA Antibody Responses by DBW Treatment Groups|Serum samples from Abatacept-treated adult participants with active rheumatoid arthritis (RA) were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody. ST was defined as the LI Period, the DBW Period, and the RI Period (Days 1-253).|For on-TRT visits: Days 1-253 (ST). For follow-up post visits for participants who discontinued drug in the ST: Day 22 after last dose of ST drug to Day 85 after last dose of ST drug|All participants treated in DBW period with at least 1 immunogenicity result (ELISA) during the Short Term. N=Number of Participants Analyzed, n=number of participants with data for that time point.||percentage of participants|||Number
748149|NCT00533897|Secondary|RI Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ECL Over Time by DBW Treatment Group|ECL screened sera for drug-specific antibodies; immunocompetition was used to identify specific anti-Abatacept reactivity. Cytotoxic leukocyte antigen 4 (CTLA4) and Possibly Immunoglobulin (Ig) Category=reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction (JNC) Category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing or negative.|For on-treatment visits: Days 170-253, includes ≤21 Days after last dose or up to 1st dose of LTE Period. For follow-up post visits for participants who discontinued drug in RI: Day 22 after last dose of drug to Day 85 after last dose of drug|All participants treated in RI period with at least 1 immunogenicity result (ECL) during RI period N=Number of Participants Analyzed, n=number of participants with data for that time point||percentage of participants|||Number
748150|NCT00533897|Secondary|RI Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA Over Time by DBW Treatment Group|Serum samples from Abatacept-treated adult participants with active RA were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.|For on-treatment visits: Days 170-253, includes ≤21 Days after last dose or up to 1st dose of LTE Period. For follow-up post visits for participants who discontinued drug in RI: Day 22 after last dose of drug to Day 85 after last dose of drug|All participants treated in RI period with at least 1 immunogenicity result (ELISA) during RI period N=Number of Participants Analyzed, n=number of participants with data for that time point.||percentage of participants|||Number
748151|NCT00533897|Secondary|DBW Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ECL At Post Visits|ECL screened sera for drug-specific antibodies; immunocompetition was used to identify specific anti-Abatacept reactivity. Cytotoxic leukocyte antigen 4 (CTLA4) and Possibly Immunoglobulin (Ig) Category=reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction (JNC) Category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing or negative.|Day 22 after last dose of drug to Day 85 after last dose of drug|These data were not summarized since there were no participants at any post visits|||||
748152|NCT00533897|Secondary|DBW Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ECL Over Time|ECL screened sera for drug-specific antibodies; immunocompetition was used to identify specific anti-Abatacept reactivity. Cytotoxic leukocyte antigen 4 (CTLA4) and Possibly Immunoglobulin (Ig) Category=reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction (JNC) Category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing or negative.|Days 86-169, includes ≤21 Days after last dose or up to 1st dose of RI Period|All participants treated in DBW period with at least 1 immunogenicity result (ECL) during DBW period. N=Number of Participants Analyzed, n=number of participants with data for that time point||percentage of participants|||Number
748153|NCT00533897|Secondary|DBW Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA at Post Visits|Serum samples from Abatacept-treated adult participants with active RA were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.|Day 22 after last dose of drug to Day 85 after last dose of drug|These data were not summarized since there were no participants at any post visits.|||||
748154|NCT00533897|Primary|Re-introduction (RI) Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA at Day 253, by DBW Period Groups|Serum samples from Abatacept-treated adult participants with active RA were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.|Day 253 (short term)|Participants treated in RI period with at least 1 immunogenicity result (ELISA) during RI period. N=Number of Participants Analyzed, n=number of participants with data for that time point.||percentage of participants|||Number
748155|NCT00533897|Secondary|DBW Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA Over Time|Serum samples from Abatacept-treated adult participants with active RA were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody. Samples were obtained during treatment (TRT) visits.|Days 86-169, includes ≤21 Days after last dose or up to 1st dose of RI Period|All participants treated in DBW period with at least 1 immunogenicity result (ELISA) during DBW period. N=Number of Participants Analyzed, n=number of participants with data for that time point.||percentage of participants|||Number
748156|NCT00533897|Secondary|LI Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by Electrochemiluminescence (ECL) Over Time|ECL screened sera for drug-specific antibodies; immunocompetition was used to identify specific anti-Abatacept reactivity. Cytotoxic leukocyte antigen 4 (CTLA4) and Possibly Immunoglobulin (Ig) Category=reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction (JNC) Category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing or negative.|For on-treatment visits: Day 1-Day 85, includes ≤21 Days after last dose or up to 1st dose of DBW Period. For follow-up post visits for participants who discontinued drug in LI: Day 22 after last dose of drug to Day 85 after last dose of drug|All participants treated in Period 1 (Lead-in Period). N=Number of Participants Analyzed, n=number of participants with data for that time point||percentage of participants|||Number
748157|NCT00533897|Secondary|Lead-in (LI) Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA Over Time|Serum samples from Abatacept-treated adult participants with active RA were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.|For on-treatment visits: Day 1-Day 85, includes ≤21 Days after last dose or up to 1st dose of DBW Period. For follow-up post visits for participants who discontinued drug in LI: Day 22 after last dose of drug to Day 85 after last dose of drug|All participants treated in LI Period who had at least 1 immunogenicity result (ELISA) during LI period. N=Number of Participants Analyzed, n=number of participants with data for that time point||percentage of participants|||Number
748158|NCT00533897|Secondary|RI Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA at Day 253, by DBW Period Placebo Group|Serum samples from Abatacept-treated adult participants with active RA were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.|Day 253 (short term)|Participants treated with Placebo in DBW period who were treated in RI period and had at least 1 immunogenicity result (ELISA) during RI period. N=Number of Participants Analyzed, n=number of participants with data for that time point||percentage of participants|||Number
748159|NCT00533897|Primary|Double-blind Withdrawal (DBW) Period; Percentage of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Antibody Responses by Enzyme-Linked Immunosorbent Assay (ELISA) at Day 169|Serum samples from all treated adult participants with active rheumatoid arthritis (RA) were screened for the presence of drug-specific antibodies using an enzyme-linked immunosorbent assay (ELISA). Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.|Day 169|Participants treated in the DBW Period with at least 1 immunogenicity result (ELISA) during DBW Period. N=Number of Participants Analyzed, n=number of participants with data for that time point||percentage of participants|||Number
748160|NCT00533949|Secondary|Prognostic Value of Pre-treatment Standardized Uptake Value (SUV) of Positron Emission Tomography (PET) Scan in Predicting Survival, Distant Metastasis, and Local-regional Control||From randomization to date of failure (either local or regional), death or last follow-up. Analysis occurs after 339 deaths have been reported.||12/2017||||
748161|NCT00533949|Secondary|Prognostic and Predictive Effects of Gross Tumor Volume on Overall Survival||From randomization to date of death or last follow-up. Analysis occurs after 339 deaths have been reported.||12/2017||||
748162|NCT00533949|Secondary|Correlation of Tumor Markers With Overall Survival, Local-regional Failure, and QOL|Biomarker data has not yet been obtained and therefore this outcome measure cannot yet be reported.|Analysis occurs after 339 deaths have been reported, estimated at 5.6 years from start of study, unless a futility bound is crossed prior to that.||||||
748163|NCT00533949|Secondary|Quality-adjusted Survival Based on EuroQoL (EQ5D)-Derived Health Utility Score||From start of treatment to 24 months.||12/2017||||
748164|NCT00533949|Secondary|Patient-reported Swallowing Ability||From start of treatment to 24 months.||12/2017||||
748165|NCT00533949|Secondary|Percentage of Patients With Decline From Baseline to 3 Months in the Lung Cancer Subscale (LCS) of the Functional Assessment of the Cancer Therapy Trial Outcome Index (FACT-TOI).|A decline of 2 points in the LCS from baseline to 3 months was considered a clinically meaningful change indicating a decline in quality of life. Comparisons are only made between radiation therapy dosing levels because the cetuximab regimen was known to be safe in combination with radiation therapy.|At baseline and 3 months.|Eligible patients who enrolled while the high dose arms were open, had baseline and 3 month assessments, and did not withdraw consent.||percentage of participants||95% Confidence Interval|Number
748166|NCT00533949|Secondary|Death During or Within 30 Days of Discontinuation of Protocol Treatment|Deaths regardless of cause and occuring during or within 30 days of discontinuation of protocol treatment were evaluated.|From start of treatment to 24 months.|Eligible patients who started study treatment and did not withdraw consent.||percentage of participants||95% Confidence Interval|Number
748322|NCT00528424|Secondary|Percent Reduction From Baseline Contracture After the Last Injection||30 days after last treatment||||||
748323|NCT00528424|Secondary|Clinical Improvement After the Last Injection||30 days after last treatment||||||
748167|NCT00533949|Secondary|Percentage of Participants With Other Grade 3-5 Adverse Events as Assessed by NCI CTCAE v3.0|Treatment-related adverse events other than esophagitis and pneumonitis were assessed graded using the CTCAE v3.0. Comparisons are only made between radiation therapy dosing levels because the cetuximab regimen was known to be safe in combination with radiation therapy.|Analysis occurs 50 months of accrual and an additional 18 months of follow-up, such that patients are followed at least 18 months from randomization.|All eligible patients enrolled while the high dose arms were open, who did not withdraw consent.||percentage of participants||95% Confidence Interval|Number
748168|NCT00533949|Secondary|Percentage of Participants With Grade 3-5 Esophagitis and Pneumonitis Adverse Events as Assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0|Treatment-related esophagitis and pneumonitis were assessed graded using the CTCAE v3.0. Comparisons are only made between radiation therapy dosing levels because the cetuximab regimen was known to be safe in combination with radiation therapy.|Analysis occurs after 50 months of accrual and an additional 18 months of follow-up, such that patients are followed at least 18 months from randomization.|All eligible patients enrolled while the high dose arms were open, who did not withdraw consent.||percentage of participants||95% Confidence Interval|Number
748169|NCT00533949|Secondary|Local-regional Failure (Reported as Two-year Estimates)|A failure for local-regional failure is the first occurrence of local or regional progression. Time is measured from the date of randomization to the date of first failure. Patients alive without local or regional failure at the time of last follow-up are censored. Patients who died without local or regional failure are considered as having competing risk at the time of death. Local-regional failure was estimated by the cumulative incidence method and 2 year estimates are reported.|Analysis occurs after 50 months of accrual and an additional 18 months of follow-up, such that patients are followed at least 18 months from randomization.|Eligible patients who did not withdraw consent; patients enrolled while high dose arms open to accrual are included in the RT comparison, patients enrolled while cetuximab arms open to accrual are included in the cetuximab comparison.||percentage of participants||95% Confidence Interval|Number
748170|NCT00533949|Secondary|Progression-free Survival|A failure for progression-free survival (PFS) is the first occurrence of local or regional progression, distant metastases, or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a nontarget lesion, or the appearance of new lesions. Time is measured from the date of randomization to the date of first failure. Patients without failure are censored at the date of last follow-up.|Analysis occurs after 50 months of accrual and an additional 18 months of follow-up, such that patients are followed at least 18 months from randomization.|Eligible patients who did not withdraw consent; patients enrolled while high dose arms open to accrual are included in the RT comparison, patients enrolled while cetuximab arms open to accrual are included in the cetuximab comparison.||months||95% Confidence Interval|Median
748171|NCT00533949|Primary|Overall Survival|Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.|Analysis occurs after 50 months of accrual and an additional 18 months of follow-up, such that patients are followed at least 18 months from randomization.|"Eligible patients who did not withdraw consent; patients enrolled while high dose arms open to accrual are included in the RT comparison, patients enrolled while cetuximab arms open to accrual are included in the cetuximab comparison. See Limitations and Caveats."||months||95% Confidence Interval|Median
748172|NCT00534001|Secondary|Abstinence|Bioverified 4-week continuous abstinence|4 weeks|||Participants|||Count of Participants
748173|NCT00534001|Primary|Prequit Change in Cigarettes Per Day|Prequit Change in Cigarettes Per Day|3-Week PreQuit Drug Manipulation Phase|Excludes participants with missing data (2 in Arm 1, 3 in Arm 2)||Cigarettes Per Day||Standard Error|Mean
748174|NCT00534092|Other Pre-specified|Number of Patients With Device/Procedure Related Adverse Events That Occurred During the Study||3+ years following first 2 years post-X-STOP implant through IDE study|||participants|||Number
748175|NCT00534092|Other Pre-specified|Number of Patients With Subsequent Lumbar Spinal Surgeries That Occurred During the Study|The surgeries that occurred subsequent to the original X-STOP implantation were categorized as revision, removal, reoperation, supplemental fixation, and other.|3+ years following first 2 years post-X-STOP implant through IDE study|||participants|||Number
748176|NCT00534092|Secondary|Change in Quality of Life Using Short Form 36-Question (SF-36) Health Survey (At ≥ 5 Years)|Quality of life was assessed by the SF-36 health survey. It includes 8 subdomains (bodily pain, physical functioning, role-physical, general health and vitality, social functioning, role-emotional, and mental health) and 2 component summaries (physical component summary [PCS] and mental component summary [MCS]). Scores for each subdomain and component summary range from 0 “worst” to 100 “best. The change from baseline to the 5 year postoperative visit for each of these domains is presented.|Baseline and 3+ years following first 2 years post-X-STOP implant through IDE study|||units on a scale||Standard Deviation|Mean
748177|NCT00534092|Secondary|Patient Satisfaction (PS) as Assessed by Zurich Claudication Questionnaire (ZCQ) Domain Scores (At ≥ 5 Years)|ZCQ is a validated outcomes instrument specific to lumbar spinal stenosis, and captures data in 3 distinct domains: SS, PF, and post-treatment Patient Satisfaction (PS). PS score is the mean of 6 questions scored from 1 to 4 if the number of responses exceeded four, a lower score represents a better outcome. Patients with mean scores <2.5 at 5 years postoperative evaluation were considered positive, which implied patient treatment satisfaction.|3+ years following first 2 years post-X-STOP implant through IDE study|||units on a scale||Standard Deviation|Mean
748195|NCT00534313|Secondary|Short-term Period: Mean Change From Baseline in Physical Component Summary Score as Measured by the Short-form 36 at Day 169|PCS=physical component score; MCS=mental component score. The Short-form 36 is a 36-item instrument with physical and mental components and covers quality of life (QoL) domains: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Responses are used to derive physical and mental component summary scores, ranging from 0 to 100, with higher scores indicating better QoL. Mean change from baseline=postbaseline value-baseline value; a higher value signifies improvement.|At Day 169 from Baseline|All randomized participants who received treatment and with baseline and postbaseline measurements at Day 169. Missing values were imputed by Last Observation Carried Forward, except for participants with only baseline observations.||Units on a scale||Standard Error|Mean
748178|NCT00534092|Secondary|Change in Symptom Severity (SS) and Physical Functioning (PF) as Using Zurich Claudication Questionnaire (ZCQ) Domain Scores (At ≥ 5 Years)|ZCQ is a validated outcomes instrument specific to lumbar spinal stenosis, and captures data in 3 distinct domains: SS, PF, and post-treatment Patient Satisfaction (PS). SS domain is based on seven questions (overall pain, pain frequency, pain in the back, pain in the leg, numbness, weakness, and balanced disturbance). The first 6 questions are scored 1 to 5. Balance disturbance is scored in a 1-3-5 scale. The SS score is the mean of all answered items in the questionnaire ranging from 1to 5. If more than two items were missing, the SS score was considered as missing. PF score is the mean of five physical function questions ranging from 1 to 4. If more than one item were missing, the PF score was considered as missing. In each domain, a lower score represents a better outcome/condition. The change is calculated as the score at 5+ years after X-STOP implantation minus the baseline score.|Baseline and 3+ years following first 2 years post-X-STOP implant through IDE study|||units on a scale||Standard Deviation|Mean
748179|NCT00534092|Primary|Treatment Success Rates (At ≥ 5 Years)|Seven treatment success criteria were defined as follows: clinically significant improvement (at least 0.5 points) in Symptom Severity (SS) domain of Zurich Claudication Questionnaire (ZCQ), clinically significant improvement (at least 0.5 points) in Physical Function (PF) domain of ZCQ, Patient Satisfaction (PS) score of <2.5 points in ZCQ, no additional lumbar spinal stenosis surgery at the index level, maintenance of distraction, no device dislodgement, no device-related complications. All 7 criteria must be met to be considered a treatment success.|3+ years following first 2 years post-X-STOP implant through IDE study|Patients who received the X-STOP and 1) completed the IDE trial or CAP/COS under IDE #G990128 or 2) were participating in the CAP/COS program, were eligible for the LTOS study. 55 included in analysis met moderately impaired baseline physical function. 14 had mildly impaired physical function at baseline and were analyzed as separate safety cohort.||percentage of participants|||Number
748180|NCT00534105|Secondary|LDL|LDL values were obtained at least 6 weeks postpartum in both the gestational diabetic group and the normal controls.|Postpartum|||mg/dl||Inter-Quartile Range|Mean
748181|NCT00534105|Secondary|HDL|Triglyceride values were obtained at least 6 weeks postpartum in both the gestational diabetic group and the normal controls.|Postpartum|||mg/dl||Inter-Quartile Range|Mean
748182|NCT00534105|Secondary|Triglyceride Values|Triglyceride values were obtained at least 6 weeks postpartum in both the gestational diabetic group and the normal controls.|Postpartum|||mg/dl||Inter-Quartile Range|Mean
748183|NCT00534105|Primary|Cholesterol|Cholesterol values were obtained at least 6 weeks postpartum from the gestational diabetic group and the normal controls|Postpartum|||mg/dl||Inter-Quartile Range|Mean
748191|NCT00534248|Secondary|Number of Participants Reporting One or More Serious Adverse Experiences by Vaccination Group During the 42-day Postvaccination Follow-up Period|"A serious adverse event is defined as any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing
hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an other important medical event based on medical judgement."|Through 42 days post-vaccination|All participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.||participants|||Number
748192|NCT00534248|Secondary|Varicella-zoster Virus (VZV) Antibody Response at 6 Weeks Post Vaccination by Vaccination Group|VZV antibody response as measured by Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) in the group that received Zostavax™ compared with the group that received placebo, based on the random subcohort population.|6 Weeks|Random subcohort population included 10% of all randomized participants randomly selected for immunogenicity assay, were vaccinated (according to actual treatment received), had results at prevaccination and at 6 weeks postvaccination. Results from participants with protocol violations that may impact the immunogenicity analysis were excluded.||gpELISA units/mL||95% Confidence Interval|Mean
748193|NCT00534248|Primary|Incidence of Confirmed Herpes Zoster (HZ) Cases by Vaccination Group|Incidence rate of HZ cases was defined as the number of confirmed HZ cases per 1000 person-years of follow-up following vaccination. Vaccine efficacy for HZ was defined as the relative reduction in incidence rate of HZ in the group that received Zostavax™ compared with the group that received placebo based on the intent-to-treat population.|2 Years|Intent-to-treat population defined as all participants randomized in the study according to the planned treatment, Zostavax or placebo, they were assigned.||number of HZ cases/1000 person-years||95% Confidence Interval|Mean
748194|NCT00534313|Secondary|Short-term Period: Number of Participants Achieving a Reduction of At Least 0.3 Unit From Baseline in HAQ-DI Scores at Day 169|The HAQ-DI assesses a participant's ability to perform the following tasks: dress/groom; arise; eat; walk; reach; grip; maintain hygiene; and maintain daily activity over a period by marking their response on a questionnaire. Responses/scores range from: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=to unable to do. Higher total score=greater disability.|At Day 169 from Baseline|All randomized participants who received at least 1 infusion of study medication at any time. Missing response values were imputed as nonresponders for participants who discontinued early after receiving study medication.||Participants|||Number
748196|NCT00534313|Secondary|Short-term Period: Population Pharmacokinetic (POPPK) Analysis of the Pharmacokinetic (PK) Parameters|PK data: summaries of concentrations and concentration versus time plots were obtained. These data were to be used to develop a POPPK model using a nonlinear mixed-effects model. Prediction of PK data for each of the 3 abatacept treatment groups using POPPK methodology was not performed, because it would not provide any relevant information over the observed PK data.|Days 1, 15, 29, 57, 85, 113, 141, and 169||||||
748197|NCT00534313|Secondary|Short-term Period: Mean Serum Trough Concentrations (Cmin) of Abatacept|Abatacept was assayed using a validated ELISA method. Cmin of abatacept was obtained from concentration versus time data.|Days 1, 15, 29, 57, 85, 113, 141, and 169|All participants who received at least 1 infusion of study medication and were evaluable for PK analysis during double-blind period. n= number of participants with evaluable PK results in each arm respectively.||µg/mL||Full Range|Geometric Mean
748198|NCT00534313|Secondary|Short-term Period: Mean Serum Concentrations of Abatacept|Abatacept was assayed using a validated enzyme linked immunosorbent assay method (ELISA). Serum concentration versus time data was analyzed in the descriptive pharmacokinetic (PK) analysis.|Days 1, 15, 29, 57, 85, 113, 141, and 169|All participants who received at least 1 infusion of study medication and were evaluable for PK analysis during double-blind period. n= number of participants with evaluable PK results in each arm respectively.||µg/mL||Standard Deviation|Mean
748199|NCT00534313|Secondary|Short-term Period: Mean Change From Baseline in the Mental Component Summary Score as Measured by the Short-form 36 at Day 169|PCS=physical component score; MCS=mental component score. The Short-form 36 is a 36-item instrument with physical and mental components and covers quality of life (QoL) domains: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Responses are used to derive physical and mental component summary scores, ranging from 0 to 100, with higher scores indicating better QoL. Mean change from baseline=postbaseline value-baseline value; a higher value signifies improvement.|At Day 169 from Baseline|All randomized and treated participants with baseline and postbaseline measurements at Day 169. Missing values were imputed by Last Observation Carried Forward, except for participants with only baseline observations.||Units on a scale||Standard Error|Mean
748200|NCT00534313|Secondary|Short-term Period: Number of Participants With Positive Responses for Serum Levels of Abatacept-specific Antibodies (Anti-Abatacept-C)|Meso Scale Discovery electrochemiluminescence, a validated, sensitive immunoassay technique (anti-abatacept assay C) was used to measure serum levels of abatacept-specific antibodies against the whole molecule (both the CTLA4 and possibly immunoglobulin G portion [anti-abatacept antibody].|From Baseline to Day 169|Participants who received abatacept and for whom baseline and at least 1 additional measurement were available during the double-blind (short-term) period.||Participants|||Number
748201|NCT00534313|Secondary|Short-term Period: Mean Percentage of Change From Baseline in Target Lesion Score at Day 169|Target lesion score measures the degree of erythema, induration, and scale of a psoriatic lesion with a diameter of at least 2 cm, selected as a target for response throughout the study period. Scores: 0=clear, 1=almost clear, 2=mild clear, 3=moderate disease, 4=severe. Percent improvement from baseline was computed using the ratio of improvement from baseline to the baseline value.|At Day 169 from Baseline|All randomized participants who received at least 1 infusion of study drug in double-blind (short-term) period. Only participants with both baseline and postbaseline values included. Missing values at Day 169 were imputed using the last observation carried forward values, except for participants with only baseline value.||Percentage of change||Standard Error|Mean
748202|NCT00534313|Secondary|Short-term Period: Number of Participants With an IGA Score of Clear or Almost Clear at Day 169|Score indicates lesion induration, scaling, and erythema: 0 = clear (no signs of plaque psoriasis except for residual discoloration); 1 = almost clear (just perceptible erythema, no induration to very slightly elevated above normal skin levels, limited amount of very fine scaling); 2 = mild disease (mild erythema, mild induration, mainly fine scaling predominates); 3 = moderate disease (moderate erythema [most plaques are red], moderate induration and/or coarse scale predominates); 4=severe (severe erythema, marked to very marked elevation of lesions, coarse thick scale predominates).|At Day 169 from Baseline|All randomized participants who received at least 1 infusion of study medication in double-blind (short-term) period. Missing response values were imputed as nonresponders for participants who discontinued early after receiving study medication.||Participants|||Number
748203|NCT00534313|Secondary|Short-term Period: Number of Participants Who Died and With SAEs, AEs, AEs Leading to Discontinuation, SAEs Leading to Discontinuation, Drug-related AEs, and Drug-related SAEs|An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=possibly, probably, or certainly related to and of unknown relationship to study treatment.|From Baseline to Day 169|All participants who received at least 1 infusion of study medication during the double-blind period.||Participants|||Number
748204|NCT00534313|Secondary|Short-term Period: Number of Participants With Marked Abnormalities in Urinalysis|Pre-Rx=pretreatment. Criteria for marked abnormality: Protein, glucose, blood, leukocyte esterase, red blood cells (RBC), white blood cells (WBC) >=2+ (or, if value >=4, or if pre-Rx value=0 or 0.5, >= 2* or if pre-RX value =1, >=3, or if pre-Rx =2 or 3, >=4).|From Baseline to Day 169|All participants who received at least 1 infusion of study medication during the double-blind period. n = number of participants with evaluable results (each arm respectively).||Participants|||Number
748205|NCT00534313|Secondary|Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry (Continued)|LLN=lower limit of normal; ULN=upper limit of normal; pre-Rx=pretreatment. Marked abnormality criteria: Glucose <65 or >220 mg/dL; glucose (fasting)<0.8*LLN or >1.5*ULN (if pre-Rx <LLN, <0.8*pre-Rx or >ULN. If pre-Rx >ULN, t>2.0*pre-Rx or <LLN). Protein (total) <0.9*LLN or >1.1*ULN (if pre-Rx <LLN, <0.9*pre-Rx or >ULN. If pre-Rx >ULN, >1.1*pre-Rx or <LLN). Albumin <0.9*LLN (if pre-Rx <LLN, <0.75* pre-Rx). Uric acid >1.5*ULN; if pre-Rx >ULN or >2*pre-Rx value.|From Baseline to Day 169|All participants who received at least 1 infusion of study medication during the double-blind period. n=number of participants with evaluable results.||Participants|||Number
749191|NCT00541658|Secondary|Percent Change From Baseline in Femoral Neck BMD, Week 104, ITT Population||Week 104|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
748206|NCT00534313|Secondary|Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry (Continued)|LLN=lower limit of normal; ULN=upper limit of normal; pre-Rx=pretreatment. Marked abnormality criteria: Sodium <0.95*LLN or >1.05*ULN (if pre-Rx<LLN, <0.95*pre-Rx or >ULN. If pre-Rx >ULN,>1.05* pre-Rx or <LLN); potassium, chloride <0.9*LLN or >1.1*ULN (if pre-Rx <LLN, <0.9*pre-Rx or >ULN. If pre-Rx >ULN, >1.1*pre-Rx or <LLN); calcium <0.8*LLN or >1.2*ULN (if pre-Rx <LLN,<0.75* pre-Rx or >ULN. If pre-Rx >ULN, >1.25* pre-Rx or <LLN); phosphorous <0.75*LLN or >1.25*ULN (if pre-Rx <LLN, <0.67*pre-Rx or >ULN. If pre-Rx >ULN, >1.33*pre-Rx or <LLN.|Baseline to Day 169|All participants who received at least 1 infusion of study medication during the double-blind period. n=number of participants with evaluable results (each arm respectively).||Participants|||Number
748207|NCT00534313|Secondary|Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry|ULN=upper limit of normal; pre-Rx=pretreatment. Marked abnormality criteria: Alkaline phosphatase (ALP), gamma-glutamyltransferase (GGT) >2*ULN (if pre-Rx >ULN, >3*pre-Rx); aspartate aminotransferase (AST), alanine transaminase (ALT) >3*ULN (if pre-Rx >ULN, >4*pre-Rx); bilirubin (total) >2*ULN (if pre-Rx >ULN, >4*pre-Rx); blood urea nitrogen (BUN) >2*pre-Rx; creatinine >1.5*pre-Rx.|Baseline to Day 169|All participants who received at least 1 infusion of study medication during the double-blind period. n=number of participants with evaluable results (each arm respectively).||Participants|||Number
748208|NCT00534313|Secondary|Short-term Period: Number of Participants With Marked Abnormalities in Hematology (Continued)|LLN=lower limit of normal; ULN=upper limit of normal; pre-Rx=pretreatment. Laboratory measurements are marked as abnormal per predefined study criteria, at any study time point. Criteria for the data presented. Leukocytes <0.75*LLN or >1.25*ULN (or, if pre-Rx value <LLN, <0.8*pre-Rx or >ULN. If pre-Rx value >ULN, >1.2*pre-Rx or <LLN); neutrophils+bands (absolute) <1.00*10^3 c/uL; lymphocytes (absolute) <0.75*10^3 c/uL or >7.50*10^3 c/uL; monocytes (absolute) >2000/mm^3; basophils (absolute) >0.40*10^3 c/uL; eosinophils (absolute) >0.75*10^3 c/uL.|From Baseline to Day 169|All participants who received at least 1 infusion of study medication during double-blind period. n=number of participants with evaluable results (each arm respectively).||Participants|||Number
748209|NCT00534313|Primary|Short-term Period: Number of Participants With ACR 20 Response at Day 169|An ACR 20 responder was a participant who had a reduction of 20% or more from baseline in scores for both tender and swollen joints and had a reduction from baseline of 20% or more in 3 out of the following 5 assessments: participant’s assessment of disease activity, participant’s global assessment of disease activity, investigator’s global assessment of disease activity, participant’s assessment of physical function by HAQ–DI, and Disease Activity Score 28-C reactive protein.|At Day 169 from Baseline|All randomized participants who received at least 1 infusion of study medication in the double-blind (short-term) period. Missing response values were imputed as nonresponders for participants who discontinued early after receiving study medication.||Participants|||Number
748210|NCT00534313|Secondary|Short-term Period: Number of Participants With Marked Abnormalities in Hematology|LLN=lower limit of normal; ULN=upper limit of normal; pre-Rx=pretreatment. Marked abnormalities are laboratory measurements marked as abnormal, per predefined study criteria, at any study time point. Criteria: Hemoglobin >3 g/dL decrease from pre-Rx value; hematocrit <0.75*pre-Rx value; erythrocytes <0.75*pre-Rx value; platelets <0.67*LLN (or, if pre-Rx value <LLN, <0.5*pre-Rx value and <100000/mm^3) or >1.5*ULN.|From Baseline to Day 169|All participants who received at least 1 infusion of study medication during double-blind period. n=number of participants with evaluable results (each arm respectively).||Participants|||Number
748211|NCT00534313|Secondary|Long-term Period: Number of Participants Achieving A Reduction of At Least 0.3 Unit From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Days 365 and 729|Per the HAQ-DI, participants assessed their own ability to perform the following tasks: dress/groom, arise, eat, walk, reach, grip, maintain hygiene, and maintain daily activity over a period by marking their responses on a questionnaire. Scoring of the HAQ-DI: 0=without any difficulty; 1=with some difficulty; 2=with much difficulty); and 3=unable to do. Greater score=greater disability. Responders with a >= 0.3 unit decrease in index scores from baseline to days 365 and 729 were considered to be improved.|Days 365 and 729 from baseline|All participants who received at least 1 infusion of abatacept in the long-term (open-label) period. (n=number of participants with responses available)||Participants|||Number
748212|NCT00534313|Secondary|Long-term Period: Mean Change From Baseline in the Short-form 36 (SF-36), Version 2, Domain and Component Scores at Days 365 and 729|PCS=physical component score; MCS=mental component score. The SF-36 is a 36-item instrument with physical and mental components and covers quality of life (QoL) domains: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Responses are used to derive physical and mental component summary scores, ranging from 0 to 100, with higher scores indicating better QoL. Mean change from baseline=postbaseline value-baseline value; a higher value signifies improvement.|At Days 365 and 729 from baseline|||Units on a scale||Standard Error|Mean
748213|NCT00534313|Secondary|Long-term Period: Mean Percentage of Change From Baseline in Target Lesion Score at Days 365 and 729|Target lesion score is a measurement of the degree of erythema, induration, and scale of a psoriatic lesion, at least 2 cm in diameter, selected as a target for response throughout the study period. The scores assigned were 0=clear, 1=almost clear, 2=mild clear, 3=moderate disease, 4=severe. Percent improvement from baseline was computed using the ratio of improvement from baseline to the baseline value.|From Baseline to Days 365 and 729|All participants who received at least 1 infusion of abatacept in the long-term (open-label) period.||Percentage of change||Standard Deviation|Mean
748214|NCT00534313|Secondary|Long-term Period: Number of Participants With an Investigators Global Assessment (IGA) Score of Clear or Almost Clear at Days 365 and 729|IGA score indicates lesion induration, scaling, and erythema: 0=clear (no signs of plaque psoriasis except for residual discoloration); 1=almost clear (just perceptible erythema, no induration to very slightly elevated above normal skin levels, limited amount of very fine scaling); 2=mild disease (mild erythema, mild induration, mainly fine scaling predominates); 3=moderate disease (moderate erythema [most plaques are red], moderate induration and/or coarse scale predominates); 4=severe (severe erythema, marked to very marked elevation of lesions, coarse thick scale predominates).|From Day 169 to Days 365 and 729|All participants who received at least 1 infusion of abatacept in the long-term (open-label) period. (n=number of participants with a response)||Participants|||Number
749192|NCT00541658|Secondary|Percent Change From Baseline in Femoral Neck BMD, Week 52 / Endpoint, ITT Population||Week 52 / Endpoint|ITT Population. LOCF at Week 52.||Percent Change||95% Confidence Interval|Least Squares Mean
748215|NCT00534313|Secondary|Long-term Period: Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR 50, ACR 70, ACR 90 Responses at Days 365 and 729|An ACR 20 (50, 70, 90) responder was a participant whose counts for both tender and swollen joints was reduced by 20% (50%, 70%, 90%, respectively) or more from baseline and who had a reduction of 20% (50%, 70%, 90%, respectively) or more from baseline in 3 of the following assessments: participant's assessment of disease activity, participant's global assessment of disease activity, Investigators Global Response, participant's assessment of physical function by Health Assessment Questionnaire Disability Index, and Disease Activity Score 28 based on C-reactive protein.|At Days 365 and 729 from Baseline|All participants who received at least 1 infusion of abatacept in the long-term (open-label) period. (n=number of participants with a response)||Percentage of participants||95% Confidence Interval|Number
748216|NCT00534313|Primary|Long-term Period: Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Drug-related AEs, AEs Leading to Discontinuation, and AEs of Interest|Presp=prespecified; acute= ≤1 hour after start of infusion; periinfusional= ≤24 hours after start of infusion. AE=any new unfavorable symptom or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=an unfavorable medical event that at any dose results in death, significant disability, drug dependency/abuse, hospitalization or prolonged hospitalization; is life-threatening, an important medical event, or a congenital anomaly/birth defect. Drug-related=possibly, probably, or certainly related and of unknown relationship to study drug.|From Day 169 to Day 729|All participants who received at least 1 infusion of abatacept during the long-term period.||Participants|||Number
748217|NCT00534352|Secondary|CD4+ Cell Count (Percent): Baseline and Median Changes From Baseline (ITT-Observed Case)||Baseline, Day 8, 14, 22, 28 & 42 and Week 48|ITT (Observed)||Percent Change from Baseline||Full Range|Median
748218|NCT00534352|Secondary|CD4+ Cell Count (x 10^6 Cell/L): Baseline and Median Changes From Baseline (ITT-Observed Case)|CD4+ Cell Count (x 10^6 cell/L): Baseline and Median Changes From Baseline (ITT-Observed Case).|Baseline, Day 8, 14, 22, 28 & 42 ans Week 48|||x 10^6 cell/L||Full Range|Median
748219|NCT00534352|Secondary|Log10 Viral Load (HIV-1 RNA Copies/mL): Mean Changes From Baseline(ITT-Observed Case)|Log10 Viral Load (HIV-1 RNA copies/mL): Mean Changes From Baseline(ITT-Observed Case).|Baseline, Day 8, 14, 22, 28 & 42 and Week 48|ITT (Observed)||copies/mL||Standard Error|Mean
748220|NCT00534352|Secondary|Virologic Response < 50 HIV-1 RNA Copies/mL (ITT-Observed Case)|Virologic Response < 50 HIV-1 RNA Copies/mL (ITT-Observed Case).|Day 8, 14, 22, 28, 42 and Week 48|ITT||participants|||Number
748221|NCT00534352|Secondary|Number of Participants With Treatment-Emergent Graded Laboratory Abnormalities(Worst Grade): Lipids- Triglycerides|"Number of participants with Treatment-Emergent Graded Laboratory Abnormalities(Worst Grade): Lipids- Triglycerides.
Worst Grade is based on the DAIDS toxicity grading scale, 0-5 : No Toxicity-Death."|Day 1 through 48 and Week 48|ITT||participants|||Number
748222|NCT00534352|Secondary|Number of Participants With Treatment-Emergent Graded Laboratory Abnormalities(Worst Grade): Lipids- Low-density Lipoprotein (LDL) Direct|"Number of participants with Treatment-Emergent Graded Laboratory Abnormalities(Worst Grade): Lipids- Low-density lipoprotein (LDL) Direct.
Worst Grade is based on the DAIDS toxicity grading scale, 0-5 : No Toxicity-Death."|Day 1 through 42 and Week 48|ITT||participants|||Number
748223|NCT00534352|Secondary|Number of Participants With Treatment-Emergent Non-Graded Laboratory Abnormalities(Worst Abnormality): Lipids- High-density Lipoprotein (HDL)|"Number of participants with Treatment-Emergent Non-Graded Laboratory Abnormalities(Worst Abnormality): Lipids- High-density lipoprotein (HDL).
Normal Range:
40 - 59 mG/dL 1.03 - 1.53 mmol/L"|Day 1 through 42 and Week 48|ITT||participants|||Number
748224|NCT00534352|Secondary|Number of Participants With Treatment-Emergent Graded Laboratory Abnormalities (Worst Grade): Lipids- Total Cholesteral|"Number of participants with Treatment-Emergent Graded Laboratory Abnormalities (Worst Grade): Lipids- Total Cholesteral.
Worst Grade is based on the DAIDS toxicity grading scale, 0-5 : No Toxicity-Death."|Day 1 through 42 and Week 48|ITT||participants|||Number
748225|NCT00534352|Secondary|Number of Participants With Treatment-Emergent Non-Graded Laboratory Abnormalities(Worst Abnormality): Glucose- Insulin|"Number of participants with Treatment-Emergent Non-Graded Laboratory Abnormalities(Worst Abnormality): Glucose- Insulin.
Normal Range: 3.0 - 27.0 ulU/mL"|Day 1 through 42 and Week 48|||participant|||Number
748226|NCT00534352|Secondary|Number of Participants With Treatment-Emergent Graded Laboratory Abnormalities (Worst Grade): Glucose- Hypoglycemia|"Number of participants with Treatment-Emergent Graded Laboratory Abnormalities (Worst Grade): Glucose- Hypoglycemia.
Worst Grade is based on the DAIDS toxicity grading scale 0-5: No Toxicity-Death."|Day 1 through 42 and Week 48|ITT||participants|||Number
748227|NCT00534352|Secondary|Number of Participants With Treatment-Emergent Graded Laboratory Abnormalities (Worst Grade): Glucose-Hyperglycemia|"Number of Participants with Treatment-Emergent Graded Laboratory Abnormalities (Worst Grade): Glucose-Hyperglycemia.
Worst Grade is based on the National Institute of Allergy and Infectious Diseases Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity grading scale, 0,1,2,3,4 and 5 : None, Mild, Moderate, Severe, Life-threatening and Death."|Day 1 through 42 and Week 48|ITT||participants|||Number
748228|NCT00534352|Primary|Number of Participants Contributing to the Pharmacokinetic (PK) Evaluations: Cmin, Cmax, AUC24 & Css,av|At visit Days 14 & 28, samples were collected pre-dose and at 1, 2, 3, 4, 6, 9, and 12 hours post-dose. An additional sample was taken at 24 hours (Day 15 or 29 as applicable) post-dose.|6 weeks|Intention To Treat (ITT) population||participants|||Number
748229|NCT00534365|Secondary|Incontinence Severity Index Score|The incontinence severity index comprises the following two questions. How often do you experience urine leakage (0=never, 1=less than once a month, 2=one or several times a month, 3=one or several times a week, 4=every day and/or night)? How much urine do you lose each time (1=drops or little, 2=more)? The total score is the score for the first question multiplied by the score for the second question (0=dry, 1-2=slight, 3-4=moderate, 6-8=severe).|12 months|||units on a scale||Standard Deviation|Mean
748230|NCT00534365|Secondary|Patient Global Impression Improvement||12 months|Please note that no all participants conducted the global improvement scale survey due to loss to follow up.||Participants|||Count of Participants
748231|NCT00534365|Secondary|Long Term Complications > 6 Weeks||6 weeks-12 months|||participants|||Number
748232|NCT00534365|Secondary|Post Operative Complications at 6 Week or Less||6 week|||participants|||Number
748233|NCT00534365|Primary|Subjective Cure of Urinary Incontinence at 12 Months After Surgery|Composite outcome defined as absence of urinary incontinence as indicated by the Incontinence Severity Index score of 0 and the absence of any additional surgical or nonsurgical treatment of stress urinary incontinence (SUI) after the index surgery.|12 months|Analysis based on per protocol enrollment||Participants|||Count of Participants
748234|NCT00534404|Secondary|Self-reported 30-day Prolonged Abstinence at 3-month Follow up||3-months post randomization|||participants|||Number
748235|NCT00534404|Secondary|Self-reported 30-day Prolonged Abstinence at 9-month Follow up||9 months post randomization|||participants|||Number
748236|NCT00534404|Primary|Self-reported 6-month Prolonged Abstinence From Smoking|Participants complete the final study survey 9 months following enrollment in the program. They are asked to report when they had last smoked a cigarette, even a puff. Participants who report that they have not smoked in the past 6 months are counted as abstinent for the purposes of our study analysis.|Measured at 9 Months post-randomization|All currently enrolled participants were invited via email to complete an online follow-up survey. Participants who did not respond to the email received phone calls from study staff asking them to complete the survey online. Results to this outcome measure are from those subjects who completed the survey.||participants|||Number
748237|NCT00534417|Secondary|Patients Experiencing Severe Symptom Burden (Physical Functioning)|The subject rates each question about physical functioning on a scale of 0 through 10, where 0 is not bad and 10 is as bad as possible. Severe symptoms are indicated by a response > or = to 7 on an item.|The questionnaire was administered on day 1 of every cycle (approximately every 4 weeks) during study treatment.|Participants who had questionnaire data available. Note that 4 items only had data available from 27 participants rather than 28.||percentage of participants|||Number
748238|NCT00534417|Post-Hoc|Overall Survival (OS)|Overall survival is defined as the time from treatment start until death from any cause. The median overall survival time is used to measure OS.|OS was measured from day 1 of treatment until time of death from any cause, up to 32.5 months.|14 patients had died, and 27 patients were censored in the OS analysis.||Months||95% Confidence Interval|Median
748239|NCT00534417|Secondary|Patients Experiencing Severe Symptom Burden (Psychiatric Symptoms)|The subject rates each question about psychiatric symptoms on a scale of 0 through 10, where 0 is not bad and 10 is as bad as possible. Severe symptoms are indicated by a response > or = to 7 on an item.|The questionnaire was administered on day 1 of every cycle (approximately every 4 weeks) during study treatment.|Participants who had questionnaire data available.||percentage of participants|||Number
748240|NCT00534417|Secondary|Patients Experiencing Severe Symptom Burden (Physical Symptoms)|The subject rates each question about physical symptoms on a scale of 0 through 10, where 0 is not bad and 10 is as bad as possible. Severe symptoms are indicated by a response > or = to 7 on an item.|The questionnaire was administered on day 1 of every cycle (approximately every 4 weeks) during study treatment.|Participants who had questionnaire data available.||percentage of participants|||Number
748241|NCT00534417|Primary|Progression-free Survival (PFS)|Disease progression was determined through radiology imaging measurements and by clinical or symptomatic progression during or after treatment. Progression is defined per RECIST v1.0 guidelines as a measurable increase in the smallest diameter of any target lesion, progression of existing non-target lesions, or the appearance of 1 or more new lesions.|PFS was measured from day 1 of treatment until time of progression (assessed every 8 weeks) or death, whichever came first, up to 32.5 months.|21 patients had experienced disease progression, and three had died. 17 patients were censored in PFS analysis.||Months||95% Confidence Interval|Median
748242|NCT00534417|Secondary|Clinical Benefit Rate|Clinical benefit rate was defined as the percentage of participants experiencing stable disease (SD) of at least 24 weeks plus complete response (CR) and partial response (PR). Response was evaluated via changes from baseline in radiological tumor measurements performed after every two treatment cycles and at the end of treatment or time of progression. Response was evaluated using RECIST version 1.0 guidelines, where CR is the disappearance of all target lesions; PR is >=30% decrease in the sum of the longest diameter(LD) of target lesions; SD is neither sufficient shrinkage in sum of longest diameter of target lesions to be PR nor increase of >=20%.|Response to treatment was assessed after every 8 weeks of treatment|||percentage of participants||95% Confidence Interval|Number
748243|NCT00534417|Secondary|Overall Response Rate|Overall response rate was defined as the percentage of participants experiencing complete response (CR) and partial response (PR). Response was evaluated via changes from baseline in radiological tumor measurements performed after every two treatment cycles and at the end of treatment or time of progression. Response was evaluated using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is >=30% decrease in the sum of the longest diameter (LD) of target lesions; Stable Disease (SD) is neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of >=20%; Progressive Disease (PD) is the increase in existing lesions or new lesions.|Response to treatment was assessed after every 8 weeks of treatment|||percentage of participants||95% Confidence Interval|Number
748244|NCT00534417|Secondary|Best Overall Response|Best overall response is defined as the best response across all time points. Response was evaluated via changes from baseline in radiological tumor measurements performed after every two treatment cycles and at the end of treatment or time of progression. Response was evaluated using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is >=30% decrease in the sum of the longest diameter (LD) of target lesions; Stable Disease (SD) is neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of >=20%; Progressive Disease (PD) is the increase in existing lesions or new lesions.|Response to treatment was assessed after every 8 weeks of treatment|||participants|||Number
748245|NCT00534417|Primary|Time to Progression (TTP)|Time to progression is defined as the time from treatment start until objective tumor progression. Progression is defined per Response Evaluation Criteria in Solid Tumors (RECIST)v1.0 guidelines as a measurable increase in the smallest diameter of any target lesion, progression of existing non-target lesions, or the appearance of 1 or more new lesions. The median time to progression is the parameter used to describe TTP.|TTP was measured from day 1 of treatment until time of progression (assessed every 8 weeks), up to 29 months.|21 patients had experienced disease progression. 20 patients were censored in TTP analysis. The 3 deaths in the PFS analysis were censored for the TTP analysis.||Months||95% Confidence Interval|Median
748246|NCT00534495|Primary|Number of Serious Adverse Events,Adverse Events, Infections, Development of MAS||At Weeks 0- 24|||events|||Number
748248|NCT00534495|Secondary|Physical Function as Determined by Childhood Health Assessment Questionnaire ( CHAQ)|"Childhood Health Assesment Questionairre dissability index (C-HAQ)-DI, Disability Index Calculation:
The index is calculated by adding the scores for each of the categories and dividing by the number of categories answered. This gives a score in the 0 to 3.0 range. lower is better"|At Weeks 12 and 24|36 Rilonacept and 35 placebo at baseline , 36 Rilonacept and 34 placebo at week 4, 33 Rilonacept and 29 placebo at week 12, and 57 combined at week 24.||units on a scale||Inter-Quartile Range|Median
748249|NCT00534495|Secondary|Pediatric Quality of Life Inventory|Visual Analog Score (0-100 mm) 0 very well , 100 very poor|At Weeks 4, 12 and 24|At Week 4 ,36 Rilonacept and 34 Placebo patient. At week 12, Rilonacept 33 patients and Placebo 29.At baseline Rilonacept 36 and Placebo 35 participants.||units on a scale||Inter-Quartile Range|Median
748250|NCT00534495|Secondary|Number of Participants With Response as Determined by JIA ACR50 and JIA ACR70||At Week 4 and week 12|Participants in the study at week 4 (rilonacept 35 and placebo 33).Participants in the study at week 12 ( Rilonacept 33 and placebo 29).||participants|||Number
748251|NCT00534495|Primary|Time to Response to Treatment, as Determined by a Modified JIA ACR30 Requiring no Fever, Coupled With a Requirement for Corticosteroid Taper in Participants Who Are Taking Corticosteroids||At Week 12|||weeks||Inter-Quartile Range|Median
748252|NCT00528372|Secondary|Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])|12-Lead ECGs were performed at entry into lead-in period Day -7 visit and Week 24/end of treatment visit (LOCF) on participants who were supine. ECGs were assessed by the investigator. Baseline was Day -7 for this parameter, and data after rescue were included.The Week 102 value is the last observation, regardless of rescue prior to Week 102 if no Week 102 measurement was available. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included. Thus, only key safety and efficacy analyses were performed for Group 2.|Baseline to Week 24 (end of Short-term Period)|Randomized participants who received at least 1 dose of study medication and who had measurements available||Participants|||Number
748253|NCT00528372|Secondary|Number of Participants With Elevated Levels of Liver Enzymes on Laboratory Test Results (Short-term and Long-term Periods)|Data after rescue was included. AST=aspartate aminotransferase; ALT=alanine aminotransferase; ALP=alkaline phosphatase. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included. Thus, only key safety and efficacy analyses were performed for Group 2.|Day 1 to Week 102 (end of Long-term Period)|Randomized participants who received at least 1 dose of study medication and with laboratory test results available||Participants|||Number
748254|NCT00528372|Secondary|Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)|Baseline was defined as the last assessment prior to the start of the first dose of the double-blind study medication. Data included from baseline up to and including the last day of treatment plus 4 days. Data after rescue were also included. ULN=upper limit of normal; preRX=pretreatment. Phosphorus, inorganic (high) defined as >=5.6 mg/dL for ages 17-65 years or >=5.1 mg/dL for ages >=66.|Baseline to Week 102 (end of Long-term Period)|Randomized participants who received at least 1 dose of study medication and with laboratory test results available||Participants|||Number
748255|NCT00528372|Primary|Adjusted Mean Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c) (Last Observation Carried Forward [LOCF]): Group 2|HbA1c was measured by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. If no Week 24 assessment was available, the last postbaseline measurement prior to Week 24 was used. For rescued participants, measurements obtained after initiation of rescue medication were not considered in calculating the primary endpoint. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.|Baseline to Week 24 (end of Short-term Period)|Randomized participants with HbA1c ≥10.1% and ≤12% at enrollment and nonmissing baseline and Week 24 LOCF values||Percent||Standard Deviation|Mean
748256|NCT00528372|Secondary|Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or missing relationship to study drug. Includes non-SAEs and hypoglycemia with onset on or after the first date/time of double-blind treatment and on or prior to the last day of short-term plus long-term treatment plus 4 days. Includes SAEs with onset on or after the first date/time of double-blind treatment and on or prior to the last day of short-term plus long-term treatment plus 30 days.|Day 1 to Week 102 (end of Long-term Period) + 30 days|Randomized participants who received at least 1 dose of study medication||Participants|||Number
748263|NCT00528372|Secondary|Adjusted Mean Change From Baseline in Fasting Plasma Glucose Levels at Week 1 (Last Observation Carried Forward [LOCF]): Group 1|Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Because the primary focus of the entire dapagliflozin program was on morning dosing in a population with HbA1c ≥7% and ≤10%, only data on AM dosing were summarized. Data after rescue medication was excluded from this analysis. Fasting plasma glucose was measured by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.|Baseline to Week 1 (end of Short-term Period)|Randomized participants with nonmissing baseline and Week 24 LOCF values||mg/dL||Standard Error|Mean
749193|NCT00541658|Secondary|Percent Change From Baseline in Femoral Neck BMD, Week 52, ITT Population||Week 52|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
748257|NCT00528372|Secondary|Adjusted Mean Change From Baseline to Week 24 in Total Body Weight in Patients With Baseline Body Mass Index ≥27 kg/m^2 (Last Observation Carried Forward)|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available) was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included. Thus, only key safety and efficacy analyses were performed for Group 2.|Baseline to Week 24 (end of Short-term Period)|Randomized participants with baseline BMI ≥27 kg/m^2 and nonmissing baseline and Week 24 values||Kilograms||Standard Error|Mean
748258|NCT00528372|Secondary|Adjusted Percentage of Participants Who Achieved Hemoglobin A1c [HbA1c] ≤6.5% (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. If no Week 24 assessment was available, HbA1c was recorded from the last postbaseline measurement prior to Week 24. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included. Thus, only key safety and efficacy analyses were performed for Group 2.|Baseline to Week 24 (end of Short-term Period)|Randomized participants with HbA1c values at both baseline and Week 24 (LOCF)||Percentage of participants|||Number
748259|NCT00528372|Secondary|Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) in Participants With Baseline Body Mass Index (BMI) ≥27 kg/m^2 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. If no Week 24 assessment was available, HbA1c was recorded from the last postbaseline measurement prior to Week 24. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included. Thus, only key safety and efficacy analyses were performed for Group 2.|Baseline to Week 24 (end of Short-term Period)|Randomized participants with baseline BMI ≥27 kg/m^2 and nonmissing baseline and Week 24 LOCF values||Percent||Standard Error|Mean
748260|NCT00528372|Secondary|Adjusted Mean Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c) in Patients With Baseline HbA1c ≥9.0% (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. If no Week 24 assessment was available, HbA1c was recorded from the last postbaseline measurement prior to Week 24. HbA1c was measured as % of hemoglobin by a central laboratory. The population included randomized patients who received treatment and had baseline HbA1c >9.0%. Data after rescue medication were excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of double-blind study drug. In cases where time of the first dose or assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study drug. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered exploratory, included to obtain initial data. No comparator arm was included. Thus, only key safety and efficacy analyses were performed in Group 2.|Baseline to Week 24 (end of Short-term Period)|Randomized participants with nonmissing baseline and Week24 LOCF values.||Percent||Standard Error|Mean
748261|NCT00528372|Secondary|Adjusted Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1c] <7.0%) at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Therapeutic glycemic response is defined as HbA1c <7.0%. Data after rescue medication was excluded from this analysis. If no Week 24 assessment was available, HbA1c was recorded from the last postbaseline measurement prior to Week 24. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included. Thus, only key safety and efficacy analyses were performed for Group 2.|Baseline to Week 24 (end of Short-term Period)|Randomized participants who had nonmissing baseline and Week 24 LOCF values||Percentage of participants|||Number
748262|NCT00528372|Secondary|Adjusted Mean Change From Baseline in Fasting Plasma Glucose Levels at Week 1 (Last Observation Carried Forward [LOCF]): Group 2|Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Because the primary focus of the entire dapagliflozin program was on morning dosing in a population with HbA1c ≥7% and ≤10%, only data on AM dosing were summarized. Data after rescue medication was excluded from this analysis. Fasting plasma glucose was measured by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.|Baseline to Week 1|Randomized participants with HbA1c ≥10.1% and ≤12% at enrollment with nonmissing baseline and Week 24 LOCF values||mg/dL||Standard Deviation|Mean
748273|NCT00528411|Secondary|Cardiopulmonary Parameters Post 6-week Treatment: NT-proBNP|NT-proBNP is measured by clinical lab, the unit is pg/mL.|6-week post treatment|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.||pg/ml||Standard Deviation|Mean
748274|NCT00528411|Secondary|Cardiopulmonary Parameters at Baseline: N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)|NT-proBNP is measured by clinical lab, the unit is pg/mL.|Baseline|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.||pg/ml||Standard Deviation|Mean
749194|NCT00541658|Secondary|Percent Change From Baseline in Femoral Neck BMD, Week 26, ITT Population||Week 26|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
748264|NCT00528372|Secondary|Adjusted Mean Change in Total Body Weight at Week 24 (Last Observation Carried Forward [LOCF]): Group 2|Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined). Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.|From Baseline to Week 24 (end of Short-term Period)|Randomized participants with HbA1c ≥10.1% and ≤12% at enrollment nonmissing baseline and Week 24 LOCF values.||Kilograms||Standard Deviation|Mean
748265|NCT00528372|Secondary|Adjusted Mean Change in Total Body Weight at Week 24 (Last Observation Carried Forward [LOCF]): Group 1|Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Because the primary focus of the entire dapagliflozin program was on morning dosing in a population with HbA1c ≥7% and ≤10%, only data on AM dosing were summarized. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined). Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.|From Baseline to Week 24 (end of Short-term Period)|Randomized participants with nonmissing baseline and Week 24 values||Kilograms||Standard Error|Mean
748266|NCT00528372|Secondary|Adjusted Mean Change From Baseline to Week 24 in Fasting Plasma Glucose Levels (Last Observation Carried Forward [LOCF]): Group 2|Group 2 was an exploratory group, included to obtain initial efficacy and safety data. No comparator arm was included. Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Data after rescue medication were excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. If no Week 24 assessment was available, glucose levels were recorded from the last postbaseline measurement prior to Week 24. For rescued participants, measurements obtained after initiation of rescue medication was not considered in calculating the endpoint.|Baseline to Week 24 (end of Short-term Period)|Randomized participants with HbA1c ≥10.1% and ≤12% at enrollment and nonmissing baseline and Week 24 LOCF values||mg/dL||Standard Deviation|Mean
748267|NCT00528372|Secondary|Adjusted Mean Change From Baseline to Week 24 in Fasting Plasma Glucose Levels (Last Observation Carried Forward [LOCF]): Group 1|Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Because the primary focus of the entire dapagliflozin program was on morning dosing in a population with HbA1c ≥7% and ≤10%, only data on AM dosing were summarized in secondary efficacy analyses. Data after rescue medication were excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. If no Week 24 assessment was available, glucose levels were recorded from the last postbaseline measurement prior to Week 24. For rescued participants, measurements obtained after initiation of rescue medication was not considered in calculating the endpoint.|Baseline to Week 24 (end of Short-term Period)|Randomized participants with nonmissing baseline and Week 24 LOCF values||mg/dL||Standard Error|Mean
748268|NCT00528372|Primary|Adjusted Mean Change From Baseline to Week 24 in Hemoglobin A1C (HbA1c) (Last Observation Carried Forward [LOCF]): Group 1|HbA1c was measured by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. If no Week 24 assessment was available, the last postbaseline measurement prior to Week 24 was used. For rescued participants, measurements obtained after initiation of rescue medication were not considered in calculating the primary endpoint. Evening dosing groups were summarized as exploratory endpoints.|Baseline to Week 24 (end of Short-term Period)|Randomized participants with nonmissing baseline and Week 24 LOCF values||Percent||Standard Error|Mean
748269|NCT00528398|Secondary|Bone Marrow at Day 7 Post-Induction Chemotherapy|Bone marrow positive, negative cells at day 7 post-induction chemotherapy for leukemia (%)|7 days post completion of induction chemotherapy|||Participants|||Count of Participants
748270|NCT00528398|Primary|Complete Remission (CR)|The peripheral blood neutrophil count is >= 1.5 x 10^9 / L and platelets more than 100 x 10^9 / L. Leukemia blast cells are not present in the peripheral blood. The cellularity of the bone marrow is more than 20% with maturation of all cell lines. The bone marrow contains less than 5% blast cells, and Auer rods is not detectable.|7 days post completion of induction chemotherapy|||Participants|||Count of Participants
748271|NCT00528411|Secondary|Cardiopulmonary Parameters Post 6-week Treatment: SpO2|SpO2 is measured by pulse oximetry, the unit is Percent. The unit % is the percentage of oxygen attached hemoglobin relative to the total hemoglobin.|6-week post treatment|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.||Percentage||Standard Deviation|Mean
748272|NCT00528411|Secondary|Cardiopulmonary Parameters at Baseline: Blood Oxygen Saturation Measured by Pulse Oximetry (SpO2)|SpO2 is measured by pulse oximetry, the unit is Percent. The unit % is the percentage of oxygen attached hemoglobin relative to the total hemoglobin.|Baseline|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.||Percent||Standard Deviation|Mean
749195|NCT00541658|Secondary|Percent Change From Baseline Total Proximal Femur BMD, Week 104 / Endpoint, ITT Population||Week 104 / Endpoint|ITT Population. Last Observation Carried Forward at Week 104.||Percent Change||95% Confidence Interval|Least Squares Mean
748275|NCT00528411|Secondary|Cardiopulmonary Parameters Post 6-week Treatment: EF|EF is measured by Echocardiogram, the unit is Percent. The ejection fraction is defined by: (LV diastolic volume - LV systolic volume)/LV diastolic volume. The unit % is the percentage change of left ventricular diastolic versus systolic volume relative to the diastolic volume. LV is the left ventricle.|6-week post treatment|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.||Percent||Standard Deviation|Mean
748276|NCT00528411|Secondary|Cardiopulmonary Parameters at Baseline: Ejection Fraction (EF)|EF is measured by Echocardiogram, the unit is Percent. The ejection fraction is defined by: (LV diastolic volume - LV systolic volume)/LV diastolic volume. The unit % is the percentage change of left ventricular diastolic versus systolic volume relative to the diastolic volume. LV is the left ventricle.|Baseline|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.||Percent||Standard Deviation|Mean
748277|NCT00528411|Secondary|Cardiopulmonary Parameters Post 6-week Treatment: DLCOSB|DLCOSB is measured by Body Box Plethysmography, the unit is Percent.|6-week post treatment|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.||Percent||Standard Deviation|Mean
748278|NCT00528411|Secondary|Cardiopulmonary Parameters at Baseline: Single Breath Diffusing Capacity for the Lungs Using Carbon Monoxide (DLCOSB)|DLCOSB is measured by Body Box Plethysmography, the unit is Percent.|Baseline|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.||Percent||Standard Deviation|Mean
748279|NCT00528411|Secondary|Cardiopulmonary Parameters Post 6-week Treatment: VT|VT is measured by Body Box Plethysmography, the unit is Liter/Minute.|6-week post treatment|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.||Liters/minute||Standard Deviation|Mean
748280|NCT00528411|Secondary|Cardiopulmonary Parameters at Baseline: Tidal Volume (VT)|VT is measured by Body Box Plethysmography, the unit is Liter/Minute.|Baseline|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.||Liters/minute||Standard Deviation|Mean
748281|NCT00528411|Secondary|Cardiopulmonary Parameters Post 6-week Treatment: RR|RR is measured by Spirometry and Body Box Plethysmography, the unit is Breaths/Minute.|6-week post treatment|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.||Breaths/minute||Standard Deviation|Mean
748282|NCT00528411|Secondary|Cardiopulmonary Parameters at Baseline: Respiratory Rate (RR)|RR is measured by Spirometry and Body Box Plethysmography, the unit is Breaths/Minute.|Baseline|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.||Breaths/minute||Standard Deviation|Mean
748283|NCT00528411|Secondary|Cardiopulmonary Parameters Post 6-week Treatment: VE|VE is measured by Spirometry and Body Box Plethysmography, the unit is Liter/Minute|6-week post treatment|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.||Liter/minute||Standard Deviation|Mean
748284|NCT00528411|Secondary|Cardiopulmonary Parameters at Baseline: Minute Ventilation (VE)|VE is measured by Spirometry and Body Box Plethysmography, the unit is Liter/Minute|Baseline|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.||Liter/minute||Standard Deviation|Mean
748285|NCT00528411|Secondary|Cardiopulmonary Parameters Post 6-week Treatment: RV|RV is measured by Body Box Plethysmography, the unit is Liter.|6-week post treatment|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.||Liter||Standard Deviation|Mean
748286|NCT00528411|Secondary|Cardiopulmonary Parameters at Baseline: Residual Volume (RV)|RV is measured by Body Box Plethysmography, the unit is Liter.|Baseline|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.||Liter||Standard Deviation|Mean
748287|NCT00528411|Secondary|Cardiopulmonary Parameters Post 6-week Treatment: TLC|TLC is measured by Body Box Plethysmography, the unit is Liter.|6-week post treatment|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.||Liter||Standard Deviation|Mean
748288|NCT00528411|Secondary|Cardiopulmonary Parameters at Baseline: Total Lung Capacity (TLC)|TLC is measured by Body Box Plethysmography, the unit is Liter.|Baseline|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.||Liter||Standard Deviation|Mean
748289|NCT00528411|Secondary|Cardiopulmonary Parameters Post 6-week Treatment: FRC|FRC is measured by Body Box Plethysmography, the unit is Liter.|6-week post treatment|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.||Liter||Standard Deviation|Mean
748290|NCT00528411|Secondary|Cardiopulmonary Parameters at Baseline: Functional Residual Capacity (FRC)|FRC is measured by Body Box Plethysmography, the unit is Liter.|Baseline|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.||Liter||Standard Deviation|Mean
748291|NCT00528411|Secondary|Cardiopulmonary Parameters Post 6-week Treatment: FEF25-75|FEF25-75 is measured by Spirometry, the unit is Liter/Second.|6-week post treatment|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.||Liter/second||Standard Deviation|Mean
748292|NCT00528411|Secondary|Cardiopulmonary Parameters at Baseline: Mean Forced Expiratory Flow Between 25% and 75% of the FVC (FEF25-75)|FEF25-75 is measured by Spirometry, the unit is Liter/Second.|Baseline|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.||Liter/second||Standard Deviation|Mean
748293|NCT00528411|Secondary|Cardiopulmonary Parameters at Post 6-week Treatment: FEV1/FVC Ratio|FEV1/FVC Ratio is measured by Spirometry, the unit is Ratio.|6-week post treatment|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.||Ratio||Standard Deviation|Mean
748294|NCT00528411|Secondary|Cardiopulmonary Parameters at Baseline: Ratio of Forced Expiratory Volume in 1 Second Over Forced Vital Capacity (FEV1/FVC Ratio)|FEV1/FVC Ratio is measured by Spirometry, the unit is Ratio.|Baseline|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.||Ratio||Standard Deviation|Mean
748296|NCT00528411|Secondary|Cardiopulmonary Parameters at Baseline: Forced Vital Capacity (FVC)|FVC is measured by Spirometry, the unit is Liter.|Baseline|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.||Liter||Standard Deviation|Mean
748297|NCT00528411|Secondary|Cardiopulmonary Parameters at Post 6-week Treatment: FEV1|FEV1 is measured by Spirometry, the unit is Liter.|6-week post treatment|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.||Liter||Standard Deviation|Mean
748298|NCT00528411|Secondary|Cardiopulmonary Parameters at Baseline: Forced Expiratory Volume in 1 Second (FEV1)|FEV1 is measured by Spirometry, the unit is Liter.|Baseline|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.||Liter||Standard Deviation|Mean
748299|NCT00528411|Secondary|Final Extent IPA Induced by 20 µM ADP at 240 Hours - Day 10 After Last Dose|IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|240 hours - Day 10 after last dose|Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.||Percentage||Inter-Quartile Range|Median
748300|NCT00528411|Secondary|Final Extent IPA Induced by 20 µM ADP at 168 Hours - Day 7 After Last Dose|IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference of baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|168 hours - Day 7 after last dose|Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.||Percentage||Inter-Quartile Range|Median
748301|NCT00528411|Secondary|Final Extent IPA Induced by 20 µM ADP at 120 Hours - Day 5 After Last Dose|IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|120 hours - Day 5 after last dose|Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.||Percentage||Inter-Quartile Range|Median
748302|NCT00528411|Secondary|Final Extent IPA Induced by 20 µM ADP at 72 Hours After Last Dose|IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|72 hours after last dose|Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.||Percentage||Inter-Quartile Range|Median
748303|NCT00528411|Secondary|Final Extent IPA Induced by 20 µM ADP at 48 Hours After Last Dose|IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|48 hours after last dose|Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.||Percentage||Inter-Quartile Range|Median
748304|NCT00528411|Secondary|Final Extent IPA Induced by 20 µM ADP at 24 Hours After Last Dose|IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|24 hours after last dose|Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.||Percentage||Inter-Quartile Range|Median
748305|NCT00528411|Secondary|Final Extent IPA Induced by 20 µM ADP at 8 Hours After Last Dose|IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|8 hours after last dose|Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.||Percentage||Inter-Quartile Range|Median
748306|NCT00528411|Secondary|Final Extent IPA Induced by 20 µM ADP at 4 Hours After Last Dose|IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|4 hours after last dose|Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.||Percentage||Inter-Quartile Range|Median
748324|NCT00528424|Primary|Reduction in Contracture to 5° or Less|"The Primary Outcome Measure is the percentage of 320 joints that were successfully treated where successfully treated was defined as reduction in contracture to 5° or less."|Within 30 days after the last injection|||% joints|||Number
748325|NCT00528450|Primary|Molecular Remission Rate|# of patients with Complete Remission|2 years|||participants|||Number
749196|NCT00541658|Secondary|Percent Change From Baseline Total Proximal Femur BMD, Week 104, ITT Population||Week 104|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
748307|NCT00528411|Secondary|Final Extent IPA Induced by 20 µM ADP at 2 Hours After Last Dose|IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|2 hours after last dose|Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.||Percentage||Inter-Quartile Range|Median
748308|NCT00528411|Secondary|Final Extent IPA Induced by 20 µM ADP at 0 Hour Before Last Dose|IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|0 hour before last dose|Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.||Percentage||Inter-Quartile Range|Median
748309|NCT00528411|Secondary|Final Extent IPA Induced by 20 µM ADP at 24 Hours After First Dose|IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|24 hours after first dose|Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.||Percentage||Inter-Quartile Range|Median
748310|NCT00528411|Secondary|Final Extent IPA Induced by 20 µM ADP at 8 Hours After First Dose|IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|8 hours after first dose|Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.||Percentage||Inter-Quartile Range|Median
748311|NCT00528411|Secondary|Final Extent IPA Induced by 20 µM ADP at 4 Hours After First Dose|IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|4 hours after first dose|Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.||Percentage||Inter-Quartile Range|Median
748312|NCT00528411|Secondary|Final Extent IPA Induced by 20 µM ADP at 1 Hour After First Dose|IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|1 hour after first dose|Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.||Percentage||Inter-Quartile Range|Median
748313|NCT00528411|Secondary|Final Extent IPA Induced by 20 µM ADP at 0.5 Hours After First Dose|IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|0.5 hours after first dose|Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.||Percentage||Inter-Quartile Range|Median
748314|NCT00528411|Primary|Slope of Extent IPA Offset Curve 4 to 72 Hours After Last Dose of Study Drug|IPA(%)=(PAb-PAt)/PAb*100.The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. The unit for the slope of IPA curve is percent/hour.|4 to 72 Hours after last dose of study drug|Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.||Percentage/Hour||Standard Error|Least Squares Mean
748315|NCT00528411|Primary|Final Extent Inhibition of Platelet Aggregation (IPA) Induced by 20 µM Adenosine Diphosphate (ADP) at 2 Hours After First Dose|IPA(%)=(PAb-PAt)/PAb*100.The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|At 2 hours after first dose of study drug|Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.||Percentage||Inter-Quartile Range|Median
748316|NCT00528424|Secondary|Change From Baseline Range of Motion After the First Injection||30 days after first treatment||||||
748317|NCT00528424|Secondary|Percent Reduction From Baseline Contracture After the First Injection||30 days after first treatment||||||
748318|NCT00528424|Secondary|Clinical Improvement After the First Injection||30 days after first treatment||||||
748319|NCT00528424|Secondary|Clinical Success After the First Injection||30 days after first treatment||||||
748320|NCT00528424|Secondary|Time to First Achieve and Maintain Clinical Success After the Last Injection||First evaluation visit on which clinical success is achieved and maintained through the Day 30 evaluation||||||
748326|NCT00528528|Secondary|Percentage of Participants With Sustained Viral Response 24 Weeks After End of Treatment (SVR24)|SVR24 was defined as having undetectable HCV RNA (i.e., no HCV RNA is detected in the participants’ plasma samples) at EOT and no confirmed detectable HCV RNA levels between EOT and 24 weeks after the last dose of study medication.|EOT (up to Week 48) and up to 24 weeks after EOT|FAS population included all randomly assigned participants who received at least 1 dose of the study medication.||Percentage of participants|||Number
748327|NCT00528528|Secondary|Change From Baseline in Log 10-Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values at End of Treatment (EOT)|Change from baseline in log 10 of Plasma HCV RNA levels were measured using the COBAS TaqMan HCV test (lower limit of quantification 25 IU/mL). The assay used real-time reverse transcription - polymerase chain reaction (RT-PCR) methodology.|Baseline (pre-dose), EOT (up to Week 48)|FAS population included all randomly assigned participants who received at least 1 dose of the study medication.||log 10 IU/mL||Standard Error|Mean
748328|NCT00528528|Secondary|Change From Baseline in Log 10-Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values at Week 12|Change from baseline in log 10 of Plasma HCV RNA levels were measured using the COBAS TaqMan HCV test (lower limit of quantification 25 IU/mL). The assay used real-time reverse transcription - polymerase chain reaction (RT-PCR) methodology. HCV RNA samples were taken pre-dose of Peg-IFN administration.|Baseline (pre-dose), Week 12|FAS population included all randomly assigned participants who received at least 1 dose of the study medication.||log 10 IU/mL||Standard Error|Mean
748329|NCT00528528|Secondary|Percentage of Participants With Partial Response|Partial response was defined as having at least 2 log drop in HCV RNA from Baseline, but not having undetectable HCV RNA (i.e., no HCV RNA is detected in the participants’ plasma samples).|Baseline (Day 1) up to EOT (up to Week 48)|FAS population included all randomly assigned participants who received at least 1 dose of the study medication.||Percentage of participants|||Number
748330|NCT00528528|Secondary|Number of Participants With Viral Breakthrough at End of Treatment (EOT)|Viral breakthrough was defined as a confirmed increase of more than 1 log 10 in HCV RNA level from the lowest level reached or a confirmed value of HCV RNA more than 100 IU/mL in participants whose HCV RNA was previously less than 25 IU/mL.|EOT (up to Week 48)|FAS population included all randomly assigned participants who received at least 1 dose of the study medication.||Participants|||Number
748331|NCT00528528|Secondary|Time to First Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level|Virologic response was either defined as having undetectable HCV RNA (i.e., no HCV RNA was detected in the participants’ plasma samples) or less than 25 IU/mL HCV RNA (i.e., the participants’ plasma samples contained traces of HCV RNA at a concentration below the limit of quantification of the viral load assay or no HCV RNA was detected in the samples).|Baseline (Day 1) up to EOT (up to Week 48)|FAS population included all randomly assigned participants who received at least 1 dose of the study medication.||Days||Full Range|Median
748332|NCT00528528|Primary|Percentage of Participants With Virologic Response at Week 12|Virologic response was either defined as having undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) (i.e., no HCV RNA was detected in the participants’ plasma samples) or less than 25 international units/milliliter (IU/mL) HCV RNA (i.e., the participants’ plasma samples contained traces of HCV RNA at a concentration below the limit of quantification of the viral load assay or no HCV RNA was detected in the samples).|End of treatment (EOT) (up to Week 48)|Full analysis set (FAS) population included all randomly assigned participants who received at least 1 dose of the study medication.||Percentage of participants|||Number
748333|NCT00528541|Secondary|Patient Comparison of Benefit to Previous Injections at Week 10|"Patients assessed the improvement in cervical dystonia after receiving the study treatment compared to previous treatment(s). Patients were required to answer How would you rate the benefit of the current treatment of cervical dystonia with botulinum toxin type A compared to the previous treatment using the following scale?. The response options were 'much worse', 'worse', 'somewhat worse', 'same as previous', 'somewhat better', 'better', and 'much better'."|Week 10|Modified intent to treat: all patients who were randomized to treatment and received 1 dose at Visit 1. Only completed assessments at this timepoint are included.||Number of Responses|||Number
748334|NCT00528541|Secondary|Physician Comparison of Benefit to Previous Injections at Week 10|"Physicians assessed the improvement in cervical dystonia after the study treatment compared to previous treatment(s) for each patient. Physicians were required to answer How would you rate the benefit of the current treatment of cervical dystonia with botulinum toxin type A compared to the previous treatment using the following scale?. The response options were 'much worse', 'worse', 'somewhat worse', 'same as previous', 'somewhat better', 'better', and 'much better'."|Week 10|Modified intent to treat: all patients who were randomized to treatment and received 1 dose at Visit 1. Only completed assessments at this time point are included.||Number of Responses|||Number
748335|NCT00528541|Secondary|Patient Visual Analog Assessment of Pain at Week 4|Patients were required to assess their pain using a Visual Analog Scale in reference to their current perception of pain at that visit. This scale consisted of a line measuring 100 mm, and patients were instructed to put a mark on the line at the point that best described 'How much pain you are having right now'. Higher scores denoted higher pain intensity: 0 indicated 'No pain' and 100 indicated 'Worst possible pain'.|Baseline, Week 4|Modified intent to treat: all patients who were randomized to treatment and received 1 dose at Visit 1.||Units on a Scale||Full Range|Median
748336|NCT00528541|Secondary|Patient Assessment of Need for Retreatment at Week 4|"Patients were queried regarding their need for another injection of botulinum toxin type A for cervical dystonia. Patients were required to answer How would you rate your need for another injection of botulinum toxin type A for cervical dystonia using the following scale?. The response options included 'absolutely requires injection', 'very much requires injection', 'somewhat requires injection' and 'does not require injection'."|Baseline, Week 4|Modified intent to treat: all patients who were randomized to treatment and received 1 dose at Visit 1. Only completed assessments at the time points are included.||Number of Responses|||Number
748337|NCT00528541|Secondary|Global Assessment of Benefit by Patient at Week 4|Patient evaluation of benefit from botulinum toxin type A treatment for cervical dystonia. Ratings were on a scale of +4 to -4, with higher scores denoting improvement in cervical dystonia: +4 was 'Complete abolishment of signs and symptoms (about 100% improvement)', 0 represented 'Unchanged', and -4 represented 'Very marked worsening (about 100% worse or greater).'|Week 4|Modified intent to treat: all patients who were randomized to treatment and received 1 dose at Visit 1.||Units on a Scale||Full Range|Median
748338|NCT00528541|Secondary|Global Assessment of Benefit by Physician at Week 4|Physician evaluation of benefit from botulinum toxin type A treatment for cervical dystonia. Ratings were on a scale of +4 to -4, with higher scores denoting improvement in cervical dystonia: +4 was 'Complete abolishment of signs and symptoms (about 100% improvement)', 0 represented 'Unchanged', and -4 represented 'Very marked worsening (about 100% worse or greater).'|Week 4|Modified intent to treat: all patients who were randomized to treatment and received 1 dose at Visit 1.||Units on a Scale||Full Range|Median
748339|NCT00528541|Secondary|Physician Assessment of Cervical Dystonia Severity at Week 4|Physician assessment of cervical dystonia severity. The rating was assessed on a scale of 0 to 10, with higher scores denoting greater severity: 0 represented 'No evidence of dystonia' and 10 represented 'Worst cervical dystonia ever.'|Baseline, Week 4|Modified intent to treat: all patients who were randomized to treatment and received 1 dose at Visit 1.||Units on a Scale||Full Range|Median
748340|NCT00528541|Secondary|Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score at Week 4|The TWSTRS assessments were conducted at each study visit. The TWSTRS is an assessment scale used to measure the impact of cervical dystonia on patients. It is comprised of 3 subscales: Severity, Disability, and Pain, each of which is scored independently. The total of these 3 comprises the TWSTRS total score which is scored from 0 (least symptoms) to 85 (worst symptoms). Higher scores indicate a greater degree of symptom severity.|Baseline, Week 4|Modified intent to treat: all patients who were randomized to treatment and received 1 dose at Visit 1.||Scores on a Scale||Full Range|Median
748341|NCT00528541|Primary|Dysphagia Incidence Over 10 Weeks|Dysphagia Incidence (difficulty swallowing) was defined as the number of patients reporting at least 1 treatment-emergent dysphagia event at any point in the study. Occurrences of dysphagia were captured as spontaneous events or were assessed during study visits using the Structured Symptom Interview (SSI) and the Dystonia Study Group Dysphagia Interview (DSGDI) for symptoms of difficulty swallowing; coughing while eating and drinking; choking while eating or drinking; or difficulty swallowing solids or liquids.|10 weeks|Modified intent to treat: all patients who were randomized to treatment and received 1 dose at Visit 1.||Number of patients|||Number
748342|NCT00528567|Secondary|Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) and Deaths|"An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events.
A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is Life-Threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant."|Through end of study: 30 June 2014: up to 77 months|Safety population, defined as all randomized participants who received at least one dose of study drug. Participants who received at least one full or partial dose of bevacizumab were included in the bevacizumab and chemotherapy arm; all other patients were analyzed in the chemotherapy arm.||Participants|||Number
748343|NCT00528567|Secondary|Percentage of Participants With Distant Disease-Free Survival (DDFS) Events|DDFS is defined as the time from randomization until the date of the first occurrence of one of the following events: Distant recurrence; Death attributable to any cause; Second primary non-breast invasive cancer (with the exception of non-melanoma Skin cancers). Percentage of participants with and without DDFS Events by the time of the data cutoff is presented.|Event driven (until data cutoff: 29 February 2012: up to 49 months)|Intent-to-treat population, defined as all randomized participants.||Percentage of participants|||Number
748344|NCT00528567|Secondary|Time to Distant Disease-Free Survival (DDFS) Event|DDFS is defined as the time from randomization until the date of the first occurrence of one of the following events: Distant recurrence; Death attributable to any cause; Second primary non-breast invasive cancer (with the exception of non-melanoma Skin cancers).|Event driven (until data cutoff: 29 February 2012: up to 49 months)|Intent-to-treat population, defined as all randomized participants.||Months||95% Confidence Interval|Median
748345|NCT00528567|Secondary|Percentage of Participants With Disease-Free Survival (DFS) Events|DFS is defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site); Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer, Second primary non-breast invasive cancer or New diagnosis of an ipsilateral or contralateral Ductal carcinoma in situ (DCIS). Percentage of Participants with and without DFI Events by the time of the data cut-off is presented.|Event driven (until data cutoff: 29 February 2012: up to 49 months)|Intent-to-treat population, defined as all randomized participants.||Percentage of participants|||Number
748346|NCT00528567|Secondary|Time to Disease-Free Survival (DFS) Event|DFS is defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site); Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer, Second primary non-breast invasive cancer or New diagnosis of an ipsilateral or contralateral Ductal carcinoma in situ (DCIS).|Event driven (until data cutoff: 29 February 2012: up to 49 months)|Intent-to-treat population, defined as all randomized participants.||Months||95% Confidence Interval|Median
748347|NCT00528567|Secondary|Percentage of Participants With Breast Cancer-Free Interval (BCFI) Events|BCFI is defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral local/regional invasive breast cancer recurrence or distant breast cancer recurrence; Contralateral invasive breast cancer; Ipsilateral or contralateral DCIS or Death only from breast cancer cause. Percentage of participants with and without BCFI events by the time of the data cutoff is presented.|Event driven (until data cutoff: 29 February 2012: up to 49 months)|Intent-to-treat population, defined as all randomized participants.||Percentage of participants|||Number
748516|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 6:Insomnia Late|Measures late insomnia on a scale of 0 (no difficulty) to 2 (unable to fall asleep again if gets out of bed).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
748348|NCT00528567|Secondary|Time to Breast Cancer-Free Interval (BCFI) Event|BCFI is defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral local/regional invasive breast cancer recurrence or distant breast cancer recurrence; Contralateral invasive breast cancer; Ipsilateral or contralateral Ductal carcinoma in situ or Death only from breast cancer cause.|Event driven (until data cutoff: 29 February 2012: up to 49 months)|Intent-to-treat participants, defined as all randomized participants.||Months||95% Confidence Interval|Median
748349|NCT00528567|Secondary|Percentage of Participants With Overall Survival (OS) Event|OS was defined as the time from randomization to death attributable to any cause. Patients for whom no death is captured in the clinical database up to the clinical cut-off date are censored at the last time they were known to be alive.|Event driven (until data cut off: 30 June 2014: up to 77 months)|Intent-to-treat population, defined as all randomized participants.||percentage of participants|||Number
748350|NCT00528567|Primary|Percentage of Participants With Invasive Disease-free Survival (IDFS) Events Excluding Second Primary Non-Breast Invasive Cancer|IDFS, was a composite endpoint defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site); Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer. Percentage of participants with and without IDFS Events by the time of data cutoff is presented.|Event driven (until data cutoff: 29 February 2012: up to 49 months)|Intent-to-treat population, defined as all randomized participants.||Percentage of participants|||Number
748351|NCT00528567|Secondary|Percentage of Participants With Overall Survival (OS) Event|OS was defined as the time from randomization to death attributable to any cause. Patients for whom no death is captured in the clinical database up to the clinical cut-off date are censored at the last time they were known to be alive.|Event driven (until data cut off: 29 February 2012: up to 49 months)|Intent-to-treat population, defined as all randomized participants.||percentage of participants|||Number
748352|NCT00528567|Primary|Time to Invasive Disease-free Survival (IDFS) Event Excluding Second Primary Non-Breast Invasive Cancer|IDFS, was a composite endpoint defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site); Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer.|Event driven (until data cutoff: 29 February 2012: up to 49 months)|Intent-to-treat population, defined as all randomized participants.||Months||95% Confidence Interval|Median
748353|NCT00528567|Primary|Percentage of Participants With Invasive Disease-free Survival (IDFS) Events|IDFS, was a composite endpoint defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site);Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer or Second primary non-breast invasive cancer. The percentage of participants with and without IDFS Events by the time of the data cutoff is presented.|Event driven (until data cutoff: 29 February 2012 up to 49 months)|Intent-to-treat population, defined as all randomized participants.||Percentage of participants|||Number
748354|NCT00528567|Secondary|Time to Overall Survival (OS) Event|OS was defined as the time from randomization to death attributable to any cause. Patients for whom no death is captured in the clinical database up to the clinical cut-off date are censored at the last time they were known to be alive.|Event driven (until data cutoff: 30 June 2014: up to 77 months)|Intent-to-treat population, defined as all randomized participants.||Months||95% Confidence Interval|Median
748355|NCT00528567|Secondary|Time to Overall Survival (OS) Event|OS was defined as the time from randomization to death attributable to any cause. Patients for whom no death is captured in the clinical database up to the clinical cut-off date are censored at the last time they were known to be alive.|Event driven (until data cutoff: 29 February 2012: up to 49 months)|Intent-to-treat population, defined as all randomized participants.||Months||95% Confidence Interval|Median
748356|NCT00528567|Primary|Time to Invasive Disease-free Survival (IDFS) Event|IDFS, was a composite endpoint defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site);Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer or Second primary non-breast invasive cancer.|Event driven (until data cutoff: 29 February 2012: up to 49 months)|Intent-to-treat population, defined as all randomized participants.||Months||95% Confidence Interval|Median
748357|NCT00528606|Secondary|Change From Baseline Range of Motion After the First Injection||30 days after first treatment to the primary joint||||||
748358|NCT00528606|Secondary|Percent Reduction From Baseline Contracture After the First Injection||30 days after first treatment to the primary joint||||||
748359|NCT00528606|Secondary|Clinical Improvement After the First Injection||30 days after first treatment to the primary joint||||||
748360|NCT00528606|Secondary|Clinical Success After the First Injection||30 days after first treatment to the primary joint||||||
748361|NCT00528606|Secondary|Time to First Achieve and Maintain Clinical Success After the Last Injection||First evaluation visit on which clinical success is achieved and maintained through the Day 30 evaluation of the primary joint||||||
748362|NCT00528606|Secondary|Change From Baseline Range of Motion After the Last Injection||30 days after last treatment to the primary joint||||||
748363|NCT00528606|Secondary|Percent Reduction From Baseline Contracture After the Last Injection||30 days after last treatment to the primary joint||||||
748364|NCT00528606|Secondary|Clinical Improvement After the Last Injection||30 days after last treatment to the primary joint||||||
749197|NCT00541658|Secondary|Percent Change From Baseline Total Proximal Femur BMD, Week 52 / Endpoint, ITT Population||Week 52 / Endpoint|ITT Population. Last Observation Carried Forward at Week 52.||Percent Change||95% Confidence Interval|Least Squares Mean
748365|NCT00528606|Primary|Clinical Success (Reduction in Contracture to 5° or Less) of the Primary Joint After the Last Injection|"The Primary Outcome Measure for patients treated with AA4500 is the percentage of 203 joints that were successfully treated where successfully treated was defined as reduction in contracture to 5° or less.
The Primary Outcome Measure for placebo treated patients is the percentage of 103 joints that were successfully treated where successfully treated was defined as reduction in contracture to 5° or less."|Within 30 days after the last injection|Modified-Intent-to-Treat population||% Joints|||Number
748366|NCT00528645|Secondary|Time to Disease Progression|Will be estimated using the method of Kaplan-Meier.|From registration to documentation of disease progression, assessed up to 2 years||||||
748367|NCT00528645|Secondary|Confirmed Tumor Response (Defined as Complete or Partial Response on 2 Consecutive Evaluations at Least 4 Weeks Apart)|"Confirmed tumor response (complete and partial) as measured by RECIST(Response Evaluation Criteria In Solid Tumors) criteria on 2 consecutive evaluations at least 4 weeks apart.
Confirmed tumor response is at least a 30% decrease in the sum of the longest diameter of target lesions and no new lesions."|6 months||||||
748368|NCT00528645|Secondary|Survival Time|Will be estimated using the method of Kaplan-Meier.|From registration to death due to any cause, assessed up to 2 years||||||
748369|NCT00528645|Primary|Progression-free Survival Rate at 12 Weeks|The progression-free survival (PFS) rate at 12 weeks will be estimated by calculating the number of patients that are alive and progression-free at 12 weeks post-registration divided by the total number of evaluable patients. All patients meeting the eligibility criteria who have signed a consent form, begun AZD0530 treatment, and are not lost to follow-up before 12 weeks, will be considered evaluable for the 12-week progression-free survival (PFS) rate.|12 weeks|||percentage of participants||95% Confidence Interval|Number
748370|NCT00528775|Secondary|Inflammation and Apoptosis as Assessed by Immunohistochemistry||2 months|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.|||||
748371|NCT00528775|Secondary|STAT3 Cross-links as Assessed by Western Blotting||2 months|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.|||||
748372|NCT00528775|Secondary|Photosensitizer (HPPH) Concentration in Tumor||2 months|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.|||||
748373|NCT00528775|Secondary|Palliation of Symptoms as Assessed by the Pulmonary Symptom Scale||2 months|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.|||||
748374|NCT00528775|Primary|Tumor Response||6 months|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.|||||
748375|NCT00528788|Primary|Change in Endothelial Cell Function|Endothelial cell function was assessed by performing flow mediated vasodilatation testing in a vascular laboratory prior to receiving doxercalciferol (either 2 mcg or 4 mcg 3 times per week at hemodialysis) and then after receiving the drug for 30 days.|1 month|prospective open-label 30-day observational study testing the effects of doxercalciferol on mediated vasodilation (FMD) among 20 dialysis pts with secondary hyperparathyroidism||percent change in FMD||Standard Deviation|Mean
748376|NCT00528801|Secondary|Volume of Total Cortical Gray Matter as Measured by Volumetric MRI.|The cortical gray matter is the gray matter of the cerebral cortex only and does not include subcortical gray matter such as hippocampus or basal ganglia.|Within 2 months of informed consent|Per protocol, no imputations.||mL||Standard Deviation|Mean
748377|NCT00528801|Secondary|Participants With Brain Lacunae as Measured by Clinical MRI|Particpants with imaging abnormalities as measured by MRI (Magnetic Resonance Imaging) specifically brain lacunae. Lacunar infarcts are 3-15 mm in diameter located at the basal ganglia, capsular and thalamic regions. Lesions located at the level of the anterior commisure are considered perivascular spaces unless >5 mm in diameter.|Within 2 months of informed consent|Per protocol, no imputation.||Participants|||Number
748378|NCT00528801|Primary|Wechsler Adult Intelligence Scale (WAIS)-III Performance IQ|Extent of neurocognitive dysfunction in neurologically asymptomatic adult patients with sickle cell disease as measured by WAIS-III performance IQ. This quotient is based on an average of 100, with a standard deviation of 15. The Wechsler intelligence scales are not considered adequate measures of extremely high and low intelligence (IQ scores above 160 and below 40, respectively). The performance IQ is derived from scores on seven subtests: picture completion, picture arrangement, block design, object assembly, digit symbol, matrix reasoning, and symbol search.|Within 2 months of signing informed consent.|Per protocol, no imputation used.||Points on a scale||Standard Deviation|Mean
748379|NCT00528840|Secondary|Change From Baseline Range of Motion After the First Injection||30 days after first treatment||||||
748380|NCT00528840|Secondary|Percent Reduction From Baseline Contracture After the First Injection||30 days after first treatment||||||
748381|NCT00528840|Secondary|Clinical Improvement After the First Injection||30 days after first treatment||||||
748382|NCT00528840|Secondary|Clinical Success After the First Injection||30 days after first treatment||||||
748383|NCT00528840|Secondary|Time to First Achieve and Maintain Clinical Success After the Last Injection||First evaluation visit on which clinical success is achieved and maintained through the Day 30 evaluation||||||
748384|NCT00528840|Secondary|Change From Baseline Range of Motion After the Last Injection||30 days after last treatment||||||
748385|NCT00528840|Secondary|Percent Reduction From Baseline Contracture After the Last Injection||30 days after last treatment||||||
748386|NCT00528840|Secondary|Clinical Improvement After the Last Injection||30 days after last treatment||||||
748387|NCT00528840|Primary|Reduction in Contracture to 5° or Less|"The Primary Outcome Measure is the percentage of 292 joints that were successfully treated where successfully treated was defined as reduction in contracture to 5° or less."|Within 30 days after the last injection|All Joints Treated With AA4500 0.58 mg||% Joints|||Number
748388|NCT00528866|Secondary|Prognostic Value of Genomic and Proteomic Markers for the Primary and Secondary Clinical Endpoints|Biomarker data has not yet been obtained and therefore this outcome measure cannot yet be reported.|Analysis can occur at the same time as the primary endpoint if data is available.||||||
748517|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 5:Insomnia Middle|Measures middle insomnia on a scale of 0 (no difficulty) to 2 (waking during the night).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
748389|NCT00528866|Secondary|Time to “Late” Grade 3+ Adverse Events (Based on CTCAE, v3.0)|Two-year rate shown (cumulative incidence method). Adverse events are graded using CTCAE v3.0. Time of first late adverse event occurrence of the Grade 3+ adverse event between 91 days and 730 days from the completion of treatment (3 weeks after the last planned docetaxel dose) calculated. Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.|From 91 to 730 days after the planned end of treatment (21 days after last docetaxel dose). Analysis occurs at the time of the primary analysis. (Patients are followed from registration to death or study termination whichever occurs first.)|All eligible patients who started study treatment||percentage of participants||95% Confidence Interval|Number
748390|NCT00528866|Secondary|Number of Patients With “Acute” Adverse Events (Based on CTCAE, v3.0)|The number of patients with at least one grade 3 or higher adverse event (AE) from start of treatment to 90 days after the planned end of treatment (21 days after last docetaxel dose). Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.|From start of treatment to 90 days after the planned end of treatment (21 days after last docetaxel dose). Analysis occurs at the time of the primary analysis. (Patients are followed until death or study termination whichever occurs first.|All eligible patients who started study treatment||participants|||Number
748391|NCT00528866|Secondary|Time to Biochemical (PSA) Failure (3-year Rate)|Failure is defined as PSA ≥ 0.4 ng/mL confirmed by a second higher PSA or initiation of non-protocol hormones. Death is considered a competing risk. Three-year failure rate and 95% confidence interval were estimated by the cumulative incidence method.|Analysis occurs after all patients have been on study for at least 3 years. (Patients are followed from registration to death or study termination whichever occurs first.)|All eligible patients who started study treatment||percentage of participants||95% Confidence Interval|Number
748392|NCT00528866|Secondary|Overall Survival (3-year Rate)|Time from registration to date of death (failure) or last follow-up (censored). Three-year rate and 95% confidence interval were estimated by the Kaplan-Meier method.|Analysis occurs after all patients have been on study for at least 3 years. (Patients are followed from registration to death or study termination whichever occurs first.)|All eligible patients who started study treatment||percentage of participants||95% Confidence Interval|Number
748393|NCT00528866|Secondary|Non-prostate Cancer Death (3-year Rate)|Time from registration to date of death due to other causes (failure), death due to prostate cancer (competing risk), or last follow-up (censored).Three-year failure rate and 95% confidence interval were estimated by the cumulative incidence method.|Analysis occurs after all patients have been on study for at least 3 years. (Patients are followed from registration to death or study termination whichever occurs first.)|All eligible patients who started study treatment||percentage of participants||95% Confidence Interval|Number
748394|NCT00528866|Secondary|Prostate Cancer Death (3-year Rate)|Time from registration to date of distant metastasis (failure), death (competing risk), or last follow-up (censored). Three-year failure rate and 95% confidence interval were estimated by the cumulative incidence method.|Analysis occurs after all patients have been on study for at least 3 years. (Patients are followed from registration to death or study termination whichever occurs first.)|All eligible patients who started study treatment||percentage of participants||95% Confidence Interval|Number
748395|NCT00528866|Secondary|Distant Metastasis (3-year Rate)|Time from registration to date of distant metastasis (failure), death (competing risk), or last follow-up (censored). Three-year failure rate and 95% confidence interval were estimated by the cumulative incidence method.|Analysis occurs after all patients have been on study for at least 3 years. (Patients are followed from registration to death or study termination whichever occurs first.)|All eligible patients who started study treatment||percentage of participants||95% Confidence Interval|Number
748396|NCT00528866|Secondary|Local-regional Progression (3 Year Rate)|Time from registration to date of local progression (failure), death (competing risk), or last follow-up (censored). Three-year failure rate and 95% confidence interval were estimated by the cumulative incidence method.|Analysis occurs after all patients have been on study for at least 3 years. (Patients are followed from registration to death or study termination whichever occurs first.)|All eligible patients who started study treatment||percentage of participants||95% Confidence Interval|Number
748397|NCT00528866|Primary|Number of Participants Free From Progression at 3 Years|Failure was defined as PSA ≥ 0.4 ng/mL after the end of radiation therapy confirmed by a second higher PSA, non-protocol hormones, local-regional progression, distant metastasis, or death, within 3 years after study registration. Freedom from progression (FFP) rate under null hypothesis was 50%; under alternative hypothesis ≥ 70%. Per Fleming's multiple testing procedure with 3 stages, 69 patients (76 allowing for 10% ineligible) were required for 90% power and type I error 0.025. If ≥ 44 of 69 patients had a FFP event, we would reject 50% FFP rate in favor of ≥ 70%. Analysis was out of 74 patients (not 69), so ≥ 44 was revised to ≥ 46.|From registration to 3 years.|All eligible patients who started study treatment||participants|||Number
748398|NCT00528879|Secondary|Adjusted Percentage of Participants Achieving Hemoglobin A1c (HbA1C) ≤6.5% at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Percent adjusted for baseline HbA1c. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.|From Baseline to Week 24|All randomized participants who received study medication and who had HbA1c values at Baseline and Week 24 (LOCF)||Percentage of participants|||Number
748416|NCT00534599|Secondary|Least Square Mean Change From Randomization to Week 1 in HAM-A Psychic Anxiety Subscale Score|Hamilton Rating Scale for Anxiety (HAM-A) consists of 14 items to evaluate anxiety. Each item is rated on a scale from 0-4, with '0' showing no anxiety (not present) and '4' showing the worst (very severe).Results based on MITT population with available data for this outcome measure.|Baseline (randomization) and then 8 weeks|||LS mean change from randomization||95% Confidence Interval|Least Squares Mean
749198|NCT00541658|Secondary|Percent Change From Baseline in Total Proximal Femur BMD, Week 52, ITT Population||Week 52|ITT Population.||Percent||95% Confidence Interval|Least Squares Mean
748399|NCT00528879|Secondary|Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 1 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Data after rescue medication was excluded from this analysis. Fasting plasma glucose was measured by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.|From Baseline to Week 1|All randomized participants who received study medication and who had nonmissing fasting plasma glucose values at baseline and Week 1 (LOCF)||mg/dL||Standard Error|Mean
748400|NCT00528879|Secondary|Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) in Participants With Baseline Body Mass Index (BMI) ≥27 kg/m^2 at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted for baseline HbA1c. HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication were excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.|From Baseline to Week 24|All randomized participants who received study medication, who had a BMI ≥27 kg/m^2 at baseline, and who had nonmissing HbA1c values at Week 24 (LOCF)||Percent||Standard Error|Mean
748401|NCT00528879|Other Pre-specified|Number of Participants With Orthostatic Hypotension|Orthostatic hypotension was defined as a decrease from supine to standing blood pressure of >20 mm Hg in systolic blood pressure or >10 mm Hg in diastolic blood pressure.|From Baseline to Week 102|All randomized participants who received treatment; n=the number of participants who were not missing blood pressure measurements.||Participants|||Number
748402|NCT00528879|Other Pre-specified|Mean Changes From Baseline in Seated Diastolic Blood Pressure|Blood pressure values were obtained after the participant was seated quietly for 5 minutes; at least 8 hours after the last ingestion of caffeine, alcohol, or nicotine; and in the same arm (right or left) consistently through out the study. Data after rescue were also included. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.|From Baseline to Week 102|All randomized participants who received study medication. n=the number of participants not missing baseline and Week t values.||mm Hg||Standard Error|Mean
748403|NCT00528879|Other Pre-specified|Mean Changes From Baseline in Seated Systolic Blood Pressure|Blood pressure values were obtained after the participant was seated quietly for 5 minutes; at least 8 hours after the last ingestion of caffeine, alcohol, or nicotine; and in the same arm (right or left) consistently through out the study. Data after rescue were also included. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.|From Baseline to Week 102|All randomized participants who received study medication. n=the number of participants not missing baseline and Week t values.||mm Hg||Standard Error|Mean
748404|NCT00528879|Other Pre-specified|Number of Participants With Changes in Baseline in Electrocardiogram Findings at Week 102 (Last Observation Carried Forward [LOCF])|12-Lead electrocardiograms (ECGs) were performed at entry into lead-in period Day -7 visit and Week 24/dnd of treatment visit (LOCF) on participants who were supine. ECGs were assessed by the investigator. Baseline was Day -7 for this parameter. Data after rescue included.The Week 102 value is the last observation, regardless of rescue prior to Week 102 if no Week 102 measurement was available.|Baseline to Week 102|All randomized participants who received at least 1 dose of study medication and who had nonmissing baseline and Week 102 (LOCF) values||Participants|||Number
748405|NCT00528879|Other Pre-specified|Number of Participants With Laboratory Test Results Meeting the Criteria for Laboratory Abnormality|BUN=blood urea nitrogen; preRX=pretreatment; ULN=upper limit of normal; AST=aspartate aminotransferase; ALT=alanine aminotransferase; ALP=alkaline phosphatase. Phosphorus, inorganic (low): ages 17-65 years, ≤1.8 mg/dL; ages≥66 years, ≤2.1 mg/dL. Phosphorus, inorganic (high): ages 17-65 years, ≥5.6 mg/dL; ages≥66 years, ≥5.6 mg/dL. Phosphorus, inorganic (low) ≤1.8 mg/dL if age 17-65 or ≤2.1 mg/dL if age ≥66. Calcium, total (high): ≥1 mg/dL from ULN and ≥0.5 mg/dL from preRx value.|Day 1 to Week 102|All randomized participants who received at least 1 dose of study medication and who had nonmissing laboratory values at baseline and Week 102.||Participants|||Number
748406|NCT00528879|Other Pre-specified|Number of Participants With Adverse Events (AEs), Hypoglycemia Events, Related AEs, Death as Outcome, Serious AEs (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs Leading to Discontinuation, and Hypoglycemia Events Leading to Discontinuation|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or missing relationship to study drug. Events captured from baseline to last dose plus 4 days for AEs and plus 30 days for SAEs during the double-blind 12-week period. Data after rescue included.|From Baseline to end of Long-term Period (Week 102)|All randomized participants who received at least 1 dose of blinded study medication||Participants|||Number
748417|NCT00534599|Secondary|Least Square Mean Change From Randomization to Week 1 in HAM-A Total Score|"Hamilton Rating Scale for Anxiety (HAM-A) consists of 14 items to evaluate anxiety. Each item is rated on a scale from 0-4, with '0' showing no anxiety (not present) and '4' showing the worst (very severe).
Results based on MITT population with available data for this outcome measure."|Baseline (randomization) and then 8 weeks|||LS mean change from randomization||95% Confidence Interval|Least Squares Mean
748418|NCT00534599|Secondary|Mean Change From Randomization to Week 8 in Q-LES-Q Item 16 (Overall Quality of Life) Score|Results based on MITT population with available data for this outcome measure.|Baseline (randomization) and then 8 weeks|||Mean change from randomization||Standard Deviation|Mean
748407|NCT00528879|Secondary|Adjusted Mean Change From Baseline in Total Body Weight at Week 24 in Participants With Baseline Body Mass Index (BMI) ≥27 kg/m^2 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined.) Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in Periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 of the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication, who had baseline BMI ≥27 kg/m^2, and who had nonmissing total body weight measurements at Week 24 (LOCF)||Kilograms||Standard Error|Mean
748408|NCT00528879|Secondary|Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) in Participants With Baseline HbA1c ≥9.0% at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. HbA1c was measured as percent of hemoglobin by a central laboratory. The population included those randomized participants who received treatment and had a baseline HbA1c > 9.0%. Data after rescue medication were excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.|From Baseline to Week 24|All randomized participants who received study medication, who had baseline HbA1c ≥9.0%, and who had nonmissing HbA1c values at Week 24 (LOCF)||Percent||Standard Error|Mean
748409|NCT00528879|Secondary|Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Percent adjusted for baseline HbA1c. Therapeutic glycemic response is defined as HbA1c <7.0%. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.|From Baseline to Week 24|All randomized participants who received study medication and were not missing baseline and Week 24 (LOCF) values||Percentage of participants|||Number
748410|NCT00528879|Secondary|Adjusted Mean Change From Baseline in Total Body Weight at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 of the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing total body weights at baseline and Week 24 (LOCF)||Kilograms||Standard Error|Mean
748411|NCT00528879|Secondary|Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Data after rescue medication was excluded from this analysis. Fasting plasma glucose was measured as milligrams per deciliter (mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.|From Baseline to Week 24|All randomized participants who received study medication and who had nonmissing fasting plasma glucose values at baseline and Week 24 (LOCF)||mg/dL||Standard Error|Mean
748412|NCT00528879|Primary|Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF])|HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 8, 12, 16, 20, and 24 in the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing HbA1c values at baseline and Week 24 (LOCF)||Percent||Standard Error|Mean
748413|NCT00534599|Secondary|Number of Patients With HAM-A Response (≥50% Score Reduction From Randomization) at Week 1|"Hamilton Rating Scale for Anxiety (HAM-A) consists of 14 items to evaluate anxiety. Each item is rated on a scale from 0-4, with '0' showing no anxiety (not present) and '4' showing the worst (very severe).
Results based on MITT population with available data for this outcome measure."|Baseline (randomization) and then 8 weeks|||Participants|||Number
748414|NCT00534599|Secondary|Least Square Mean Change From Randomization to Week 1 in CGI-S Score|Results based on MITT population with available data for this outcome measure.|Baseline (randomization) and then 8 weeks|||LS mean change from randomization||95% Confidence Interval|Least Squares Mean
748415|NCT00534599|Secondary|Least Square Mean Change From Randomization to Week 1 in HAM-A Somatic Anxiety Subscale Score|"Hamilton Rating Scale for Anxiety (HAM-A) consists of 14 items to evaluate anxiety. Each item is rated on a scale from 0-4, with '0' showing no anxiety (not present) and '4' showing the worst (very severe).
Results based on MITT population with available data for this outcome measure."|Baseline (randomization) and then 8 weeks|||LS mean change from randomization||95% Confidence Interval|Least Squares Mean
748419|NCT00534599|Secondary|Mean Change From Randomization to Week 8 in Q-LES-Q Item 15 (Satisfaction With Medication) Score|Results based on MITT population with available data for this outcome measure.|Baseline (randomization) and then 8 weeks|||Mean change from randomization||Standard Deviation|Mean
748420|NCT00534599|Secondary|Least Square Mean Change From Randomization to Week 8 in Quality of Life Enjoyment and Satisfaction Questionaire (Q-LES-Q) Percent Maximum Total Score|"The Q-LES-Q score is the sum of the first 14 items, larger values indicating a higher perceived quality of life enjoyment and satisfaction. This total score was converted to a % maximum score using the following scoring conversion: %Maximum score = (Total score-14)*(100/560)rounded to an integer.
Results based on MITT population with available data for this outcome measure."|Baseline (randomization) and then 8 weeks|||LS mean change from randomization||95% Confidence Interval|Least Squares Mean
748421|NCT00534599|Secondary|Number of Patients With HAM-A Remission (Total Score ≤7) at Week 8|Hamilton Rating Scale for Anxiety (HAM-A) remission is derived from the HAM-A total score and is defined as a HAM-A total score of ≤7. 1=Yes, 0=No Results based on MITT population with available data for this outcome measure.|Baseline (randomization) and then 8 weeks|||Participants|||Number
748422|NCT00534599|Secondary|Number of Patients With HAM-A Response (≥50% Score Reduction From Randomization) at Week 8|Hamilton Rating Scale for Anxiety (HAM-A) response is derived from the HAM-A total score and is defined as a decrease from baseline total HAM-A score of at least 50%. (1=Yes, 0=No) Results based on MITT population with available data for this outcome measure.|Baseline (randomization) and then 8 weeks|||Participants|||Number
748423|NCT00534599|Secondary|Least Square Mean Change From Randomization to Week 8 in HAM-A Somatic Anxiety Subscale Score|"The HAM-A Somatic cluster subscale is defined as the sum of the following 7 HAM-A items: somatic (muscular), somatic (sensory), cardiovascular symptoms, respiratory symptoms, gastrointestinal symptoms, genitourinary symptoms and autonomic system (i.e. items 7-13 respectively).
Results based on MITT population with available data for this outcome measure."|Baseline (randomization) and then 8 weeks|||LS mean change from randomization||95% Confidence Interval|Least Squares Mean
748424|NCT00534599|Secondary|Least Square Mean Change From Randomization to Week 8 in HAM-A Psychic Anxiety Subscale Score|The HAM-A psychic anxiety factor subscale is defined as the sum of the following 7 HAM-A factors: anxious mood, tension, fears, insomnia, intellectual, depressed mood and behavior at the interview (i.e.items 1-6 and 14, respectively) Results based on MITT population with available data for this outcome measure.|Baseline (randomization) and then 8 weeks|||LS mean change from randomization||95% Confidence Interval|Least Squares Mean
748425|NCT00534599|Secondary|"Number of Patients With Clinical Global Impression-Global Improvement (CGI-I) Score of Much/Very Much Improved at Week 8"|"This pertains to the CGI-I scale which rates improvement of anxiety on a scale from 1-7, with '1' showing the best improvement(Very Much Improved) and '7' showing the worst improvement (Very Much Worse) as compared to the baseline visit. A rating of '2' indicates 'Much Improved'.
Results based on MITT population with available data for this outcome measure."|Baseline (randomization) and then 8 weeks|||Participants|||Number
748426|NCT00534599|Secondary|Least Square Mean Change From Randomization to Week 8 in Clinical Global Impression-Severity of Illness (CGI-S) Score|"The CGI-S is assessed on a seven-point scale ranging from most extremely ill/very much worse (7) to normal/very much improved (1).
Results based on MITT population with available data for this outcome measure."|Baseline (randomization) and then 8 weeks|||LS mean change from randomization||95% Confidence Interval|Least Squares Mean
748427|NCT00534599|Primary|Least Square Mean Change From Randomization to Week 8 in Hamilton Rating Scale for Anxiety (HAM-A) Total Score|"Hamilton Rating Scale for Anxiety (HAM-A) consists of 14 items to evaluate anxiety. Each item is rated on a scale from 0-4, with '0' showing no anxiety (not present) and '4' showing the worst (very severe).
Results based on MITT population with available data for this outcome measure. Least square mean of each treatment was adjusted for baseline value."|Baseline (randomization) and then 8 weeks|Results participant numbers are based on Modified Intention to Treat (MITT) population set; The participants in the overall study are participants randomized.||units on scale||95% Confidence Interval|Least Squares Mean
748428|NCT00534638|Secondary|Number of Male Subjects Reporting Any SAEs That Are Causally Related to Vaccination, in All Male Subjects|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from dose1-Day 0 to Visit 5-18.5 years of age)|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
748429|NCT00534638|Secondary|Number of Female Subjects Reporting Any SAEs That Are Causally Related to Vaccination, in a Female Subjects|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Dose 1-Day 0 to Visit 5-18.5 years of age)|The Total Vaccinated cohort included all vaccinated subjects for whom data were available||Subjects|||Number
748430|NCT00534638|Secondary|Number of Female Subjects With New Onset of Autoimmune Diseases (NOADs).|NOADs include colitis ulcerative, juvenile arthritis, type 1 diabetes mellitus, coeliac disease and Chron's disease, Basedow's disease, erythema nodosum VIIth nerve paralysis and psoriasis.|Between Visit 1 (at Day 0) and Visit 5 (at 18.5 years of age)|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
748431|NCT00534638|Secondary|Number of Subjects Reporting Pregnancies With Onset During the Study|Pregnancies with onset during the study were classified by their outcome. Outcomes included live infant with no apparent congenital anomaly, elective termination with no apparent congenital anomaly, spontaneous abortion with no apparent congenital anomaly, ectopic pregnancy, stillbirth with no apparent congenital anomaly and molar pregnancy. One additional pregnant subject was lost to follow-up during the study.|Between Visit 1 (at Day 0) and Visit 5 (at 18.5 years of age)|The analysis was based on the total number of pregnant subjects reported, part of the Total Vaccinated cohort, which all vaccinated subjects for whom data were available.||Subjects|||Number
748441|NCT00534638|Secondary|Number of Female Subjects With Vaccine Effectiveness Against Oropharyngeal Infection With HPV-16/18 Serotypes|The analysis of total effectiveness was based on stratified Mantel-Haenszel adjusted for clustering. The effectiveness was computed as 1- the prevalence odd ratio in HPV vaccinated subjects from the investigated group (prevalence rate in HPV vaccinated subjects from the investigated arm/prevalence rate in all subjects from Arm C).|At the time of visit 5 (at 18.5 years of age)|The analysis was based on the female study participants from the Total Enrolled cohort on effectiveness, which included all study participants who were previously enrolled in the immunization phase, and those who joined the trial at Visit 5.||Subjects|||Number
748432|NCT00534638|Secondary|Titres for Anti-HPV-16 and Anti-HPV-18 Antibodies, by Gender, in a Subset of Subjects.|The antibody concentrations against HPV-16 and HPV-18 were determined by Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 8 ELISA units per millilitre (EL.U/mL) for anti-HPV-16 and 7 EL.U/mL for anti-HPV-18 at Visits 1 and 4 and 19 EL.U/mL for HPV-16 and 18 EL.U/mL for HPV-18 at Visit 5. The Immunogenicity subset comprised the male study participants from the Cervarix/Engerix-B A Group plus female study participants from the same Cervarix/Engerix-B A Group.|At the time of visits 1 and 4 (at Day 0 and Month 7) and at the time of Visit 5 (18.5 years of age)|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. Subjects who acquired either HPV-16 or HPV-18 infection during the trial were excluded from the ATP cohort for immunogenicity.||Titres||95% Confidence Interval|Geometric Mean
748433|NCT00534638|Secondary|Number of Subjects With HPV-16 and HPV-18 Antibody Concentrations Equal to or Above the Cut-off Values, by Gender, in a Subset of Subjects.|The antibody concentrations against HPV-16 and HPV-18 were determined by Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 8 ELISA units per millilitre (EL.U/mL) for anti-HPV-16 and 7 EL.U/mL for anti-HPV-18 at Visits 1 and 4 and 19 EL.U/mL for HPV-16 and 18 EL.U/mL for HPV-18 at Visit 5. The Immunogenicity subset comprised the male study participants from the Cervarix/Engerix-B A Group plus female study participants from the same Cervarix/Engerix-B A Group.|At the time of Visit 1 (at Day 0), Visit 4 (at Month 7) and Visit 5 (at 18.5 years of age)|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. Subjects who acquired either HPV-16 or HPV-18 infection during the trial were excluded from the ATP cohort for immunogenicity.||Subjects|||Number
748434|NCT00534638|Secondary|Number of Subjects Reporting SAEs Assessed by the Investigator as Possibly Related to Vaccination.|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period up to the Visit 5 (18.5 years of age)|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.||Subjects|||Number
748435|NCT00534638|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs) and SAEs Causally Related to Vaccination, in a Subset of Subjects|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Dose 1 (at Day 0) until Month 12|The analysis was based on the Total Vaccinated Cohort subset of Male subjects with active follow-up Month 0-Month 12 for SAEs, which included the male subjects in the Diary Card subset and the remaining Cervarix/Engerix-B Group male subjects.||Number|||Number
748436|NCT00534638|Secondary|Number of Subjects Reporting Medically Significant Conditions (MSCs), in a Subset of Subjects.|MSCs are defined as AEs prompting emergency room or physician visits that are not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that are not related to common diseases. Common diseases include: upper respiratory infections sinusitis, pharyngitis, gastroenteritis, urinary tract infections and injury.|From Dose 1 (at Day 0) until Month 12|The analysis was performed on the Total Vaccinated Cohort - Diary Card subset - a subset of male adolescents from the Cervarix/Engerix-B and Engerix-B Groups, selected for active assessment of safety using diary cards.||Subjects|||Number
748437|NCT00534638|Secondary|Number of Subjects Reporting Rash and Urticaria, in a Subset of Subjects.||Within 30 minutes following vaccination|This analysis was based on the Total Vaccinated Cohort - the Diary Card subset - a subset of male adolescents from Cervarix/Engerix-B A and Engerix-B Groups selected for active assessment of safety using diary cards.||Subjects|||Number
748438|NCT00534638|Secondary|Number of Subjects Reporting Any, Grade 3 and Related to Vaccination Unsolicited Adverse Events (AEs), in a Subset of Subjects.|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|Within 30 days (Days 0 - 29) after any vaccination|This analysis was based on the Total Vaccinated Cohort - the Diary Card subset - a subset of male adolescents from Cervarix/Engerix-B A and Engerix-B Groups selected for active assessment of safety using diary cards.||Subjects|||Number
748439|NCT00534638|Secondary|Number of Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects.|Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastrointestinal symptoms, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|Within 7 days (Days 0 - 6) after any vaccination|The analysis was based on the Total vaccinated cohort - the Diary card subset, which included a subset of male adolescents from Cervarix/Engerix-B and Engerix-B groups, who were selected for active assessment of safety using diary cards.||Subjects|||Number
748440|NCT00534638|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects.|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Relationship analysis was not performed.|Within 7 days (Days 0 - 6) after any vaccination|The analysis was based on the Total vaccinated cohort - the Diary card subset, which included a subset of male adolescents from Cervarix/Engerix-B and Engerix-B groups, who were selected for active assessment of safety using diary cards.||Subjects|||Number
748460|NCT00536341|Secondary|Progression-Free Survival|Measured from first treatment to disease progression and assessed using Kaplan-Meier methods.|Every 3 months during treatment until disease progression and every 6 months thereafter, up to 5 years|All treated patients, all dose levels||months||95% Confidence Interval|Median
748442|NCT00534638|Primary|Number of Female Subjects With Vaccine Overall Effectiveness Against Genital Infection With Human Papilloma Virus (HPV) 16/18 Serotypes|The analysis of overall effectiveness was based on stratified Mantel-Haenszel adjusted for clustering. The effectiveness was computed as 1- the prevalence odd ratio in all subjects from the investigated group (prevalence rate in all subjects from the investigated arm/prevalence rate in all subjects from Arm C).|At the time of visit 5 (at 18.5 years of age)|The analysis was based on the female study participants from the Total Enrolled cohort on effectiveness, which included all study participants who were previously enrolled in the immunization phase, and those who joined the trial at Visit 5.||Subjects|||Number
748443|NCT00534794|Secondary|Ocular Comfort Score at 12 Hours|Ocular comfort was measured on a 0 (more uncomfortable) to 10 (more comfortable) scale.|12 hours|||units on a scale||Standard Deviation|Mean
748444|NCT00534794|Primary|Change in Ocular Itch Score From Baseline|Ocular itch was measured on a 0 (none) to 4 (severe itch with continual desire to rub eyes) scale. Negative values for change from baseline represent favorable outcomes.|0 hours, 12 hours|||units on a scale||Standard Deviation|Mean
748445|NCT00534833|Secondary|Number of Participants Reporting At Least 1 Solicited Injection Site and Systemic Reaction Following Booster Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV|"Solicited injection site reactions: Tenderness, Erythema, and Swelling; Systemic reactions: Fever (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability.
Grade 3 reactions are defined as: Tenderness - cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling - ≥ 5cm; Fever - temperature ≥ 39.5ºC; Vomiting - ≥6 episodes per 24 hours; Crying - inconsolable crying for >3 hours; Somnolence - sleeping most of the time or difficulty to wake up; Anorexia - refuses ≥3 feeds; and Irritability - inconsolable."|Day 0 up to Day 7 post-vaccination|Safety was assessed on the safety analysis (intent-to-treat) population.||Participants|||Number
748446|NCT00534833|Primary|Geometric Mean Titers (GMTs) of Vaccine Antibodies Following Booster Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV|Immunogenicity were assessed by means of enzyme immunoassay (EIA) for antibodies to the vaccine antigens 28 days after the Booster vaccination|Day 28 post-vaccination|Geometric Mean Titers (GMTs) of Vaccine Antibodies were assessed in the per protocol population.||Titers||95% Confidence Interval|Geometric Mean
748447|NCT00534833|Primary|Summary of Antibody Persistence and Immunogenicity Booster Response in Participants Who Were Vaccinated With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV|"Immunogenicity was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-polyribosyl ribitol phosphate (PRP) antibodies, enzyme immunoassay (EIA) for anti-Tetanus, and serum neutralization for anti-Diphtheria.
Booster responses defined as titers ≥ 10 mIU/mL for anti-Hep Bs; ≥ 0.15 μg/mL for anti-PRP; ≥ 0.01 IU/mL for anti-Tetanus and anti-Diphtheria at Day 28 after the third vaccination; Pertussis Toxoid (PT) and Filamentous Hemagglutinin (FHA) 4-fold increase, and individual titers ratio."|28 Days post-vaccination|Antibody persistence and immunogenicity booster responses were assessed in a subset of participants available for the endpoint, the per-protocol population.||Participants|||Number
748448|NCT00536263|Secondary|Change From Baseline in Liver Biopsy Score|"Method for biopsy scoring was Knodell Scoring System (Histology Activity Index-HAI Score System):
Score I (periportal +/- bridging necrosis): 0 (none) to 10 (multilobular necrosis).
Score II (Intralobular degeneration and focal necrosis): 0 (none) to 4 (Marked [involvement of >2/3 of lobules or nodules]).
Score III (portal inflammation): 0 (none) to 4 (Marked [dense packing of
inflammatory cells in >2/3 of portal tracts]).
Score IV (fibrosis): 0 (none) to 4 (cirrhosis)."|Baseline to 24 weeks after end of treatment|Treated participants from designated sites||Units on a scale||Standard Deviation|Mean
748449|NCT00536263|Secondary|Hepatitis B Surface Antigen (HBs) Seroconversion|HBs seroconversion was defined as having HBsAg Loss and Anti-HBs Positive|End of treatment (EOT) and 24 weeks after EOT|Treated participants||Participants|||Number
748450|NCT00536263|Secondary|Hepatitis B Surface Antigen (HBsAg) Loss|HBsAg Loss was tested by assay of Abbott MEIA|End of treatment (EOT) and 24 weeks after EOT|Treated participants||Participants|||Number
748451|NCT00536263|Secondary|Number of Participants With Combined Response|Combined response was defined as HBV DNA <20,000 IU/mL and HBe seroconversion and alanine aminotransferase (ALT) normalization|End of treatment (EOT) and 24 weeks after EOT|Treated participants||Participants|||Number
748452|NCT00536263|Secondary|Number of Participants With Biochemical Response|Biochemical response was defined as alanine aminotransferase (ALT) normalization.|End of treatment (EOT) and 24 weeks after EOT|Treated participants||Participants|||Number
748453|NCT00536263|Secondary|Number of Participants With HBV-DNA Undetectable|Undetectable HBV-DNA was defined as having a level <6 IU/mL by polymerase chain reaction (PCR).|End of treatment (EOT) and 24 weeks after EOT|Treated participants||Participants|||Number
748454|NCT00536263|Secondary|Number of Participants With HBV-DNA < 200 IU/mL|HBV-DNA was tested by assay of Roche Cobas Taqman (the test lowest limit is 6 IU/mL)|End of treatment (EOT) and 24 weeks after EOT|Treated participants||Participants|||Number
748455|NCT00536263|Secondary|Number of Participants With Hepatitis B Virus - Deoxyriboncleic Acid (HBV-DNA) <20,000 IU/mL|"HBV-DNA was tested by assay of Roche Cobas Taqman (the test
lowest limit is 6 IU/mL)"|End of treatment (EOT) and 24 weeks after EOT|Treated participants||Participants|||Number
748456|NCT00536263|Secondary|HBe Seroconversion|HBe seroconversion was defined as HBeAg Loss and Anti-HBeAg Positive. These were tested by assay of Abbott MEIA.|End of treatment (EOT) and 24 weeks after EOT|Treated participants||Participants|||Number
748457|NCT00536263|Secondary|Number of Participants With HBeAg Loss|HBeAg Loss was tested by assay of Abbott MEIA|Up to Treatment Week 48|Treated participants||Participants|||Number
748458|NCT00536263|Primary|Number of Participants With Hepatitis B Envelope Antigen (HBe or HBeAg) Loss|HBeAg Loss was tested by Abbott Microparticle Enzyme Immunoassay (MEIA)|24 weeks after end of treatment (EOT)|Treated participants||Participants|||Number
748459|NCT00536341|Secondary|Overall Survival|Defined as the time from Day 1 of treatment administration to date of death from any cause, estimated using Kaplan-Meier methods.|Every 3 months until treatment discontinuation, expected average of 6 months and then every 6 months thereafter up to 5 years|All treated patients, all dose levels||months||95% Confidence Interval|Median
749199|NCT00541658|Secondary|Percent Change From Baseline in Total Proximal Femur BMD, Week 26, ITT Population||Week 26|ITT Population.||Percent Change||95% Confidence Interval|Least Squares Mean
748461|NCT00536341|Primary|Complete Response Rate|An improvement in complete response to at least 60% following treatment, assessed using CT scans, clinical/lab examinations, and bone marrow aspirations, as defined by National Cancer Institute Working Group Response Criteria.|At 12 weeks during treatment and 2 months post-treatment until disease progression, projected 8 months|All patients deemed evaluable and evaluated for response||participants|||Number
748462|NCT00536341|Primary|Number of Adverse Events as a Measure of Safety and Tolerability|Recorded from first treatment until 30 days after last treatment and assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0|63 months|All treated patients||participants|||Number
748463|NCT00536380|Primary|Change in the Urticaria Activity Score (UAS) From Baseline to the Final Week for Desloratadine 5 mg Versus Desloratadine 20 mg|The UAS is a composite diary-recorded score. The diary recorded scores included wheal score and pruritus score with numeric severity intensity ratings of 0 = none to 3 = intense. The scoring was to be done twice daily within one hour of arising and in the evening, approximately 12 hours later. Scoring was “reflective”, covering the 12-hour period since the previous recording. The daily UAS is the average of the morning and evening scores. The final week by definition was the terminal week. It was the last week participants stayed for the treatment period.|Baseline and 4 treatment weeks|Intent to treat population||Units on a scale||Standard Error|Least Squares Mean
748464|NCT00536471|Secondary|Summary of Adverse Events Leading to Discontinuation||over 9 months|Number of randomized participants in each treatment group.||participants|||Number
748465|NCT00536471|Secondary|Statistically Significant Abnormal Laboratory Values at 9 Month Endpoint||9 months|Number of participants with a normal baseline and at least one post-baseline measurement.||participants|||Number
748466|NCT00536471|Secondary|Statistically Significant Abnormal Laboratory Values at Anytime During 9 Months||over 9 months|Number of participants with a normal baseline at at least one post-baseline measurement.||participants|||Number
748467|NCT00536471|Secondary|Statistically Significant Abnormal Laboratory Values at Anytime/12 Week Endpoint|The number of participants with statistically significant abnormal lab values at anytime and at 12 week endpoint were the same.|over 3 months|Number of participants with a normal baseline and at least one post-baseline measurement.||participants|||Number
748468|NCT00536471|Secondary|Statistically Significant Changes in Baseline to 9 Month Endpoint Laboratory Values - Hemoglobin||Baseline, 9 months|Number of participants with non-missing data at baseline and at least one post-baseline visit.||millimoles per Liter (iron)||Standard Deviation|Least Squares Mean
748469|NCT00536471|Secondary|Statistically Significant Changes in Baseline to 9 Month Endpoint Laboratory Values - Alkaline Phosphatase||baseline, 9 months|Number of participants with non-missing data at baseline and at least one post baseline visit.||Units per Liter||Standard Deviation|Least Squares Mean
748470|NCT00536471|Secondary|Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Platelet Count||Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and at least post-baseline visit.||Billions per Liter||Standard Deviation|Least Squares Mean
748471|NCT00536471|Secondary|Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Chloride, Urea Nitrogen, Cholesterol, Sodium||Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and at least one post-baseline visit.||millimole per Liter||Standard Deviation|Least Squares Mean
748472|NCT00536471|Secondary|Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Mean Cell Volume (MCV)||Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and at least one post-baseline visit.||femtoliter||Standard Deviation|Least Squares Mean
748473|NCT00536471|Secondary|Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Hematocrit||Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and at least one post-baseline visit.||Proportion of 1.0||Standard Deviation|Least Squares Mean
748474|NCT00536471|Secondary|Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Bilirubin, Creatinine, Uric Acid||Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and at least one post-baseline visit.||micromole per Liter||Standard Deviation|Least Squares Mean
748475|NCT00536471|Secondary|Abnormal Vital Signs at 9 Month Endpoint||9 months|Number of participants with a normal baseline and at least one post-baseline measurement.||participants|||Number
748476|NCT00536471|Secondary|Abnormal Vital Signs at 12 Week Endpoint||12 weeks|Number of participants with a normal baseline and at least one post-baseline measurement.||participants|||Number
748477|NCT00536471|Secondary|Abnormal Vital Signs at Anytime Over 9 Months||over 9 months|Number of participants with a normal baseline and at least oone post-baseline measurement.||participants|||Number
748478|NCT00536471|Secondary|Abnormal Vital Signs at Anytime Over 12 Weeks||over 12 weeks|Number of participants wtih a normal baseline and at least one post-baseline measurement.||participants|||Number
748479|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in Weight||Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||kilograms||Standard Error|Least Squares Mean
748480|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in Pulse Rate||Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||beats per minute||Standard Error|Least Squares Mean
748481|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in Blood Pressure|Sitting systolic and diastolic blood pressure.|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||mm Hg||Standard Error|Least Squares Mean
748482|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in the Social Adaptation Self-evaluation Scale (SASS) Total Score|A 21-item self-rated scale that evaluates patient social motivation and behavior in depression. Each of the 21 items is scored from 0 (minimal social adjustment) to 3 (maximal social adjustment). Total score ranges from 0 to 60.|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
748514|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 8:Retardation|Measures slowness of thought and speech; impaired ability to concentrate; decreased motor activity on a scale of 0 (normal speech and thought) to 4 (complete stupor).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
748483|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH-CPFQ)|A 7-item patitent-rated questionnaire pertaining to a patient's cognitive and physical well-being. It assesses motivation, wakefulness, energy, focus, recall, word-finding difficulty, and mental acuity. Each of the 7 questions is scored on a 6-point scale ranging fom 1 (greater than normal) to 6 (totally absent). Total score ranges from 7 to 42.|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
748484|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoint in the Clinical Global Impression-Severity Scale (CGI-S)|Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients.|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
748485|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in Pain Numerical Rating Scale (NRS)|Item 1=Average musculoskeletal pain severity over the last week as measured by an 11-point Likert scale. Scores range from 0 (no pain) to 10 (worst possible pain). Item 7=How much they have been bothered by pain over the last week. Scores range from 0 (not bothered at all)to 10 (extremely bothered).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Deviation|Least Squares Mean
748486|NCT00536471|Secondary|Probability of Response at 12 Week Endpoint|Probability of response as measured by ≥ 50% Improvement in the HAMD17 Total Score and ≥ 50% Improvement in the QIDS16SR Total Score. The visitwise percentages of patients meeting criteria in the Acute Therapy Phase for response (visitwise binary outcome, yes/no) will be analyzed using a categorical, pseudo-likelihood-based repeated measures approach. This analysis will include the fixed, categorical effects of treatment, investigator, visit, and treatment-by-visit interaction, as well as the continuous, fixed covariate of baseline score.|12 weeks|Number of participants with non-missing data at baseline and post-baseline visit.||probability of response||Standard Error|Least Squares Mean
748487|NCT00536471|Secondary|Probability of Remission at 12 Week Endpoint and Sustained Remission at 9 Month Endpoint|Probability of remission as measured by the HAMD17 Total Score ≤ 7 and by the QIDS16SR Total Score ≤ 5. The visitwise percentages of patients meeting criteria in the Acute Therapy Phase for remission (visitwise binary outcome, yes/no) will be analyzed using a categorical, pseudo-likelihood-based repeated measures approach. This analysis will include the fixed, categorical effects of treatment, investigator, visit, and treatment-by-visit interaction, as well as the continuous, fixed covariate of baseline score.|12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||probability of remission||Standard Error|Least Squares Mean
748488|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in 16-Item Quick Inventory of Depressive Symptomatology Self Report (QIDS16SR) Total Score|A 16-item patient-rated measure of depressive symptomatology. The total score ranges from 0 to 27 with higher scores indicative of greater severity.|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Deviation|Least Squares Mean
748489|NCT00536471|Secondary|Path Analysis of BPOMS Total Score to Overall Improvement in SDS Total Score - Percent of Total Effect|For Group A, at least one effect was in the opposite direction, percent of total effect was not calculated.|Over 12 weeks|||percent of total effect|||Number
748490|NCT00536471|Secondary|Path Analysis of BPOMS Total Score to Overall Improvement in Sheehan Disability Scale (SDS) Total Score|Relative contribution of improvement on the mood states, defined by BPOMS total score (determined from subscales) to overall improvement in SDS total score using path analysis.|over 12 weeks|||coefficient|||Number
748491|NCT00536471|Secondary|Path Analysis of BPOMS Total Score to Overall Improvement in HAMD-24 Item 7 - Percent of Total Effect|For Group A, at least one effect was in the opposite direction, percent of total effect was not calculated.|over 12 weeks|||percent of total effect|||Number
748492|NCT00536471|Secondary|Path Analysis of BPOMS Total Score to Overall Improvement in HAMD-24 Item 7|Relative contribution of improvement on the mood states, defined by BPOMS total score (calculated from subscales) to overall improvement in work and activities, HAMD-24 item 7 using path analysis.|Over 12 weeks|||coefficient|||Number
748493|NCT00536471|Secondary|Change From Baseline to 9 Month Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscores|The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Individual item scores range from 0 to 10. Total scores range from 0 to 30 with higher values indicating greater disruption in the patient's work/social/family life.|Baseline, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
748494|NCT00536471|Secondary|Change From Baseline to 12 Week Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscores|The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Individual item scores range from 0 to 10. Total scores range from 0 to 30 with higher values indicating greater disruption in the patient's work/social/family life.|Baseline, 12 weeks|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
748495|NCT00536471|Secondary|Change From Baseline to 9 Month Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment)|The 30-item BPOMS measures mood states and has 6 factors: tension-anxiety, depression-dejection, anxiety-hostility, fatigue, confusion, and vigor. Item scores: 0 (not at all) to 4 (extremely). Each factor scores range from 0 to 20. The Total score is sum of all factor scores minus the factor score for vigor (Total=Ten+Dep+Ang+Fat+Con-Vig).|Baseline, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
748515|NCT00536471|Secondary|Change From Baseline to 9 Month Endpoint in HAMD-24 - Item 7:Work and Activities|Item 7 of the HAMD-24 assesses loss of interest or pleasure in work and activities and is an essential symptom in MDD. Scores range from 0 (no difficulty/no loss) to 4 (difficulty/loss).|Baseline, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
754591|NCT00584935|Primary|2. The Proportion of Patients That Experience a Grade 3, Grade 4, or Grade 5 Toxicity Based Reaction on the NCI-CTC System at the Time of Their Infusions and During Follow-up Visits.||16 weeks||||||
748496|NCT00536471|Secondary|Change From Baseline to 12 Week Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment).|The 30-item BPOMS measures mood states and has 6 factors: tension-anxiety, depression-dejection, anxiety-hostility, fatigue, confusion, and vigor. Item scores: 0 (not at all) to 4 (extremely). Each factor scores range from 0 to 20. The Total score is sum of all factor scores minus the factor score for vigor (Total=Ten+Dep+Ang+Fat+Con-Vig).|Baseline, 12 weeks|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
748497|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 24B:Worthlessness|Measures feelings of worthlessness on a scale of 0 (absent) to 4 (severe).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
748498|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 23B:Hopelessness|Measures feelings of hopelessness on a scale of 0 (absent) to 4 (expresses feelings of discouragement, despair, and/or pessimism about the future which cannot be dispelled).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
748499|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 22B:Helplessness|Measures feelings of helplessness on a scale of 0 (absent) to 4 (severe).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
748500|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 21:Obsessional and Compulsive Symptoms|Measures obsessional and compulsive symptoms on a scale of 0 (absent) to 2 (severe).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
748501|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 20:Paranoid Symptoms|Measures paranoid symptoms on a scale of 0 (none) to 2 (severe).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
748502|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 19: Depersonalization and Derealization|Measures feelings of unreality on a scale of 0 (absent) to 4 (incapacitating).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
748503|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 18B:Diurnal Variation-Severity|Measures the severity of the diurnal variation on a scale of 0 (none) to 2 (severe).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
748504|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 18A:Diurnal Variation|Measures whether symptoms are worse in morning or evening on a scale of 0 (no variation), 1 (worse in morning), or 2 (worse in evening).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
748505|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 17:Insight|Measures insight on a scale of 0 (acknowledges being depressed and ill) to 2 (denies being ill at all).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
748506|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 16:Loss of Weight|Measures weight loss since last visit on a scale of 0 (no weight loss) to 2 (definite weight loss caused by present illness).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
748507|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 15:Hypochondriasis|Measures hypochondriasis on a scale of 0 (not present) to 4 (hypochondriacal delusions).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
748508|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 14:Genital Symptoms|Measures genital symptoms (loss of libido, menstrual disturbances) on a scale of 0 (absent) to 2 (severe).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
748509|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 13:Somatic Symptoms/General|Measures general somatic symptoms on a scale of 0 (none) to 2 (any clear-cut symptoms).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
748510|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 12:Somatic Symptoms/Gastrointestinal|Measures gastrointestical somatic symptoms on a scale of 0 (none) to 2 (difficulty eating, requires medication for symptoms).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
748511|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 11:Anxiety (Somatic)|Measures physiological concomitants of anxiety on a scale of 0 (absent) to 4 (incapacitating).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
748512|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 10:Anxiety (Psychic)|Measures anxiety on a scale of 0 (no difficulty) to 4 (fears expressed)|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
748513|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 9:Agitation|Measures agitation on a scale of 0 (none) to 4 (hand-wringing, nail-biting)|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
752635|NCT00561600|Secondary|Analysis of Metal Ion Release - Erythrocyte Chromium|Erythrocyte Chromium|4 months post-operative|Metal ion sub-study was limited to two sites. All participants with available data are presented below.||ug/L||Full Range|Median
748518|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 4:Insomnia Early|Measures early insomnia on a scale of 0 (no difficulty falling asleep) to 2 (complains of nightly difficulty falling asleep).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
748519|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 3:Suicide|Measures thoughts of suicide on a scale of 0 (absent) to 4 (attempts suicide).|Baseline, 12 weeks, 9 Months|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
748520|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 2:Feelings of Guilt|Measures feelings of guilt on a scale of 0 (absent) to 4 (very guilty).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
748521|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in the HAMD-24 Item 1:Depressed Mood|Measures depressed mood on a scale of 0 (absent) to 4 (very depressed).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
748522|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in the HAMD-24 Total Score||Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
748523|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in the 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score and HAMD-24 Subscales (8 Week Endpoint for Maier Subscale)|The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe). Please see baseline demographics for subscale total scores.|Baseline, 8 weeks, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
748524|NCT00536471|Primary|Change From Baseline to 8 Weeks in 24-Item Hamilton Depression Rating Scale (HAMD-24) Item 7 (Work and Activities)|Item 7 of the HAMD-24 assesses loss of interest or pleasure in work and activities and is an essential symptom in MDD. Scores range from 0 (no difficulty/no loss) to 4 (difficulty/loss).|baseline, 8 weeks|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
748525|NCT00536484|Secondary|Change in Urgency Severity Visual Analog Scale (VAS) Relative to Baseline|"The urgency severity VAS Scale records the subject’s assessment of the severity of urgency. VAS scale ranges from 1 ‘Very Mild’ to 10 ‘Very Severe’. Negative change indicated improvement.
Change: mean at observation minus mean at baseline."|Baseline, Week 2, Week 6 and Week 12|"Participants in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 2, Week 6 or Week 12 (last observation carried forward [LOCF]).
Number analyzed=participants at Week 12 LOCF"||scores on a scale||Standard Error|Least Squares Mean
748526|NCT00536484|Secondary|Categorical Change in Urgency Perception Scale (UPS) Relative to Baseline|"UPS scores range from 0 (I am usually not able to hold urine) to 2 (I am usually able to finish what I am doing before going to the toilet [without leaking]). Improvement: positive score change; No change: score change=0; Deterioration: negative score change"|Baseline, Week 2, Week 6 and Week 12|"Participants in the Full Analysis Set (FAS) with non-missing baseline values and Week 2, Week 6 (last observation carried forward [LOCF]) or Week 12 (LOCF) values.
Number analyzed=participants at Week 12 LOCF."||percentage of participants|||Number
748527|NCT00536484|Secondary|Categorical Change in Patient Perception of Bladder Condition (PPBC) Score Relative to Baseline|PPBC scale range: 1=’does not cause me any problems at all’ to 6=’causes me many severe problems’. Major improvement=negative score change of 2 or more from baseline; minor improvement=negative score change of 1 or more from baseline; no change=0 score change from baseline; Deterioration=positive score change from baseline|Baseline, Week 2, Week 6 and Week 12|"Participants in the Full Analysis Set (FAS) with non-missing baseline values and Week 2, Week 6 (last observation carried forward [LOCF]) or Week 12 (LOCF) values.
Number analyzed=participants at Week 12 LOCF."||percentage of participants|||Number
748528|NCT00536484|Secondary|Change in Overactive Bladder Questionnaire (OAB-q) at Week 12 Relative to Baseline - Health Related Quality of Life (HRQL) Subscales|"Each item rated by subject on a Likert scale 1 (least symptom bother) to 6 (most symptom bother). Raw scores were transformed to a score from 0 to 100. Once transformed a positive change indicates improvement.
Change: mean at Week 12 minus mean at baseline."|Baseline and Week 12|"Participants in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12.
The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 valid efficacy assessment, either at baseline or post baseline"||scores on a scale||Standard Error|Least Squares Mean
748529|NCT00536484|Secondary|Change in Overactive Bladder Questionnaire (OAB-q) at Week 12 Relative to Baseline - Symptom Bother Scale|"Each item rated by subject on a Likert scale 1 (least symptom bother) to 6 (most symptom bother). Raw scores were transformed to a score from 0 to 100. Once transformed a negative change indicates improvement.
Change: mean at Week 12 minus mean at baseline"|Baseline and Week 12|"Participants in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12.
The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 valid efficacy assessment, either at baseline or post baseline"||scores on a scale||Standard Error|Least Squares Mean
748530|NCT00536484|Secondary|Change in Frequency-urgency Sum Per 24 Hours Relative to Baseline|Change in frequency urgency sum is total urinary sensation scale (USS) ratings recorded for all micturitions in 24-hour day. Number of USS ratings per 24 hours is sum of all USS ratings divided by the total diary days collected at that visit. USS scale: 1=No feeling of urgency to 5=Unable to hold:leak urine. Numerical decrease indicates improvement|Baseline, Week 2, Week 6 and Week 12|"Participants in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 2, Week 6 or Week 12 (last observation carried forward [LOCF]).
Number analyzed=participants at Week 12 LOCF."||scores on a scale||Standard Error|Least Squares Mean
748587|NCT00536913|Secondary|Morning Peak Expiratory Flow (mPEF)|Change in average value from the run-in to the treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation.Missing data between the first and last entry were estimated using linear interpolation.|Daily during run-in and daily during treatment period of 6 weeks|||Liters/min||Standard Deviation|Mean
748531|NCT00536484|Secondary|Change in Number of Nocturnal Urgency Episodes Per 24 Hours Relative to Baseline|Change in number of nocturnal urgency episodes (NUE) recorded in bladder diary. NUE had urinary sensation scale (USS) rating of 3 or more that occurred between time subject went to bed and time he or she arose to start next day. Number of NUE per 24 hours was calculated as sum of all NUE divided by total number of diary days collected at that visit|Baseline, Week 2, Week 6 and Week 12|Number of subjects with Nocturnal Urgency Episodes >0 per 24 hours and non-missing change from baseline to Week 2, Week 6 (last observation carried forward [LOCF]) or Week 12 (LOCF). Only subjects with at least 1 episode during baseline 3-day diary period were included in analysis.||number of episodes per 24 hours||Standard Error|Least Squares Mean
748532|NCT00536484|Secondary|Change in Nocturnal Micturition Episodes Per 24 Hours Relative to Baseline|Change in number of nocturnal micturitions (NM) recorded in the bladder diary. NM were defined as micturitions that occurred between the time the subject went to bed and the time he or she arose to start the next day. The number of NM per 24 hours was calculated as the sum of all NM divided by the total number of diary days collected at that visit.|Baseline, Week 2, Week 6 and Week 12|Number of subjects with Baseline Nocturnal Micturitions >0 per 24 and non-missing change from baseline to Week 2, Week 6 (last observation carried forward [LOCF]) or Week 12 (LOCF). Only subjects with at least 1 episode during baseline 3-day diary period were included in analysis.||number of episodes per 24 hours||Standard Error|Least Squares Mean
748533|NCT00536484|Secondary|Change in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours Relative to Baseline|Change in number of UUI episodes (urinary sensation scale [USS] rating of 5) recorded in the bladder diary. Scale: 0=no feeling of urgency to 5=unable to hold; leak urine|Baseline, Week 2, Week 6 and Week 12|Number of subjects with Baseline UUI >0 per 24 hours and non-missing change from baseline to Week 2, Week 6 (last observation carried forward [LOCF]) or Week 12 (LOCF). Only subjects with at least 1 episode during baseline 3-day diary period were included in analysis.||number of episodes per 24 hours||Standard Error|Least Squares Mean
748534|NCT00536484|Secondary|Change in Number of Severe Urgency Episodes Per 24 Hours Relative to Baseline|Change in number of severe urgency episodes (urinary sensation scale [USS] rating of 4 or more) recorded in the bladder diary. Scale: 0=no feeling of urgency to 5=unable to hold; leak urine. Number of severe urgency episodes per 24 hours calculated as sum of all severe urgency episodes divided by total number of diary days collected at that visit.|Baseline, Week 2, Week 6 and Week 12|Number of subjects with baseline severe urgency episodes >0 per 24 hours and non-missing change from baseline to Week 2, Week 6 (last observation carried forward [LOCF]) or Week 12 (LOCF). Only those with at least 1 episode during baseline 3-day diary period were included.||number of episodes per 24 hours||Standard Error|Least Squares Mean
748535|NCT00536484|Secondary|Change in Number of Urgency Episodes Per 24 Hours Relative to Baseline|Change in number of urgency episodes (urinary sensation scale [USS] rating of 3 or more) recorded in the bladder diary. Scale: 0=no feeling of urgency to 5=unable to hold; leak urine. The number of urgency episodes per 24 hours was calculated as the sum of all urgency episodes divided by the total number of diary days collected at that visit.|Baseline, Week 2, Week 6 and Week 12|Number of subjects with Baseline Urgency Episodes >0 per 24 hours and non missing change from baseline to Week 2, Week 6 (last observation carried forward [LOCF]) or Week 12 (LOCF). Only subjects with at least 1 episode during baseline 3-day diary period were included in analysis.||number of episodes per 24 hours||Standard Error|Least Squares Mean
748536|NCT00536484|Secondary|Change in Mean Number of Micturition Episodes Per 24 Hours Relative to Baseline|"The number of micturitions per 24 hours was calculated as the sum of all micturitions divided by the total number of diary days collected at that visit.
Change: mean at observation minus mean at baseline"|Baseline, Week 2 and Week 6|"Participants in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 2 or Week 6 (last observation carried forward [LOCF]).
The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 valid efficacy assessment, either at baseline or post baseline (n=placebo; n=fesoterodine)"||number of episodes per 24 hours||Standard Error|Least Squares Mean
748537|NCT00536484|Primary|Change in Mean Number of Micturition Episodes Per 24 Hours at Week 12 Relative to Baseline.|"The number of micturitions per 24 hours was calculated as the sum of all micturitions divided by the total number of diary days collected at that visit.
Change: mean at Week 12 minus mean at Baseline"|Baseline and Week 12|Participants in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12 (last observation carried forward [LOCF)). The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 valid efficacy assessment, either at baseline or post baseline.||number of episodes per 24 hours||Standard Error|Least Squares Mean
748538|NCT00536510|Secondary|Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) After 12 Weeks|Percent change from baseline in High Density Lipoprotein Cholesterol (HDL-C) after 12 weeks is calculated as the difference between week 12 measure and baseline measure divided by baseline measure *100|12 weeks|Full Analysis Set: consisted of all randomized patients who (i) took at least one dose of the treatment period study medication and (ii) had a baseline measurement and at least one measurement during Weeks 5 to 12. The last available lipid values during Weeks 5 to 12 were used for patients who had no lipid data collected at Week 12.||Percent Change||95% Confidence Interval|Least Squares Mean
748539|NCT00536510|Primary|Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) After 12 Weeks|Low Density Lipoprotein Cholesterol (LDL-C) after 12 weeks is calculated as the difference between week 12 measure and baseline measure divided by baseline measure *100|12 weeks|Full Analysis Set: consisted of all randomized patients who (i) took at least one dose of the treatment period study medication and (ii) had a baseline measurement and at least one measurement during Weeks 5 to 12. The last available lipid values during Weeks 5 to 12 were used for patients who had no lipid data collected at Week 12.||Percent Change||95% Confidence Interval|Least Squares Mean
748540|NCT00536575|Primary|Objective Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment|The percentage of patients who experience an objective benefit from treatment, determined by the treating physician after reviewing key laboratory values from blood and urine.|24 months|||percentage of participants|||Number
748541|NCT00536731|Secondary|Forced Expiratory Volume in 1 Second (FEV1)|Change in the FEV1from baseline to week 6 (calculated as a mean using all available data after randomization)|Baseline to 6 weeks|||Liters||Standard Deviation|Mean
759237|NCT00615290|Secondary|CD4 Count at 3 Months||3 months after inclusion|All enrolled patients with data at 3 months||cells/cubic millimeter||Inter-Quartile Range|Median
748542|NCT00536731|Secondary|Percentage of Rescue Free Days|Change in the Percentage of Rescue Free Days from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed. Rescue-free Day defined as day and night with no use of rescue medication.|Baseline to 6 weeks|||Percentage of days||Standard Deviation|Mean
748543|NCT00536731|Secondary|Percentage of Asthma Control Days|Change in the Percentage of Symptom Control Days from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed. Asthma Control Day: no symptoms (asthma symptom score=0) night and day, no awakenings due to asthma, no rescue medication.|Baseline to 6 weeks|||Percentage of days||Standard Deviation|Mean
748544|NCT00536731|Secondary|Percentage of Symptom-free Days|Change in the Percentage of Symptom-free Days from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed. Symptom-free Day: no symptoms (asthma symptom score=0) night and day, and no awakenings due to asthma.|Baseline to 6 weeks|||Percentage of days||Standard Deviation|Mean
748545|NCT00536731|Secondary|Use of Rescue Medication, Total|Change in the Use of Rescue Medication (Total) from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed|Baseline to 6 weeks|||Inhalations||Standard Deviation|Mean
748546|NCT00536731|Secondary|Use of Rescue Medication, Day|Change in the Use of Rescue Medication (Day) from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed|Baseline to 6 weeks|||Inhalations||Standard Deviation|Mean
748547|NCT00536731|Secondary|Use of Rescue Medication, Night|Change in the Use of Rescue Medication (Night) from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed|Baseline to 6 weeks|||Inhalations||Standard Deviation|Mean
748548|NCT00536731|Secondary|Percentage of Nights With Awakenings Due to Asthma|"Change in the Percentage of Nights With Awakenings Due to Asthma from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed. The participants answered Yes or No whether she/he woke up during the night due to asthma."|Baseline and 6 weeks|||Percentage of night||Standard Deviation|Mean
748549|NCT00536731|Secondary|Asthma Symptom Score, Total|Change in the Asthma Symptom Score (Total) from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed. Daily scale:0 = No symptoms; 1 = Mild symptoms; 2 = Moderate symptoms; 3 = Severe symptoms.|Baseline to 6 weeks|||Units on a scale||Standard Deviation|Mean
748550|NCT00536731|Secondary|Asthma Symptom Score, Day|Change in the Asthma Symptom Score (Day) from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed. Daily scale:0 = No symptoms; 1 = Mild symptoms; 2 = Moderate symptoms; 3 = Severe symptoms.|Baseline to 6 weeks|||Units on a scale||Standard Deviation|Mean
748551|NCT00536731|Secondary|Asthma Symptom Score, Night|Change in the Asthma Symptom Score (Night) from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed. Daily scale:0 = No symptoms; 1 = Mild symptoms; 2 = Moderate symptoms; 3 = Severe symptoms.|Baseline to 6 weeks|||Units on a scale||Standard Deviation|Mean
748552|NCT00536731|Secondary|Evening Peak Expiratory Flow (PEF)|Change in the Evening PEF from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomisation). No imputation of missing data was performed|Baseline to 6 weeks|||Liters/min||Standard Deviation|Mean
748553|NCT00536731|Primary|Morning Peak Expiratory Flow (PEF)|Change in the Morning PEF from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomisation). No imputation of missing data was performed|Baseline to 6 weeks|||Liters/min||Standard Deviation|Mean
748554|NCT00536744|Secondary|Time to Wound Closure, Wound Closure Area and Volume Between Active and Control 12 Weeks Post Initial Application, Subject Pain Assessment Between Active and Control 24 Weeks Post Initial Application||12 weeks post initial application and 24 weeks post initial application||||||
748555|NCT00536744|Primary|The Primary Variable for Effectiveness of the dermaPACE Device Will be Assessed by Comparing the Incidence of Complete Wound Closure of the dermaPACE and Control Groups 12 Weeks Post Initial Application.||12 weeks post initial application|ITT||participants||95% Confidence Interval|Number
748556|NCT00536809|Secondary|Change From Baseline to Study Completion in Aspartate Aminotransferase, Alanine Aminotranferease, and Alkaline Phosphatase|Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.|Baseline to study completion (up to 135 days)|All-Treated Population for Phase II||International Units/Liter||Standard Deviation|Mean
748557|NCT00536809|Secondary|Change From Baseline to Study Completion in Creatinine Clearance|Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.|Baseline to study completion (up to 135 days)|All-Treated Population for Phase II||milliliters/minute||Standard Deviation|Mean
762935|NCT00659360|Secondary|Overall Survival|Median was estimated. The Kaplan-Meier method will be used to estimate overall survival estimates.|Up to 5 years|||months||95% Confidence Interval|Median
748558|NCT00536809|Secondary|Change From Baseline to Study Completion in Creatinine, Total Bilirubin, and Direct Bilirubin|Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.|Baseline to study completion (up to 135 days)|All-Treated Population for Phase II||micromoles/Liter||Standard Deviation|Mean
748559|NCT00536809|Secondary|Change From Baseline to Study Completion in Sodium, Potassium, and Calcium|Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.|Baseline to study completion (up to 135 days)|All-Treated Population for Phase II||millimoles/Liter||Standard Deviation|Mean
748560|NCT00536809|Secondary|Change From Baseline to Study Completion in International Normalized Ratio|Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.|Baseline to study completion (up to 135 days)|All-Treated Population for Phase II||International sensitivity index 1-5||Standard Deviation|Mean
748561|NCT00536809|Secondary|Change From Baseline to Study Completion in Prothrombin Time and Partial Thromboplastin Time|Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.|Baseline to study completion (up to 135 days)|All-Treated Population for Phase II||seconds||Standard Deviation|Mean
748562|NCT00536809|Secondary|Change From Baseline to Study Completion in White Blood Cells and Platelets|Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.|Baseline to study completion (up to 135 days)|All-Treated Population for Phase II||GI/L (.25/liter)||Standard Deviation|Mean
748563|NCT00536809|Secondary|Change From Baseline to Study Completion in Hemoglobin and Neutrophils|Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.|Baseline to study completion (up to 135 days)|All-Treated Population for Phase II||grams/Liter||Standard Deviation|Mean
748564|NCT00536809|Secondary|Change From Baseline to Study Completion in Blood Pressure|Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.|Baseline to study completion (up to 135 days)|All-Treated Population for Phase II||millimeters of mercury||Standard Deviation|Mean
748565|NCT00536809|Secondary|Change From Baseline to Study Completion in Heart Rate|Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.|Baseline to study completion (up to 135 days)|All-Treated Population for Phase II||beats per minute||Standard Deviation|Mean
748566|NCT00536809|Secondary|Change From Baseline to Study Completion in Weight|Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.|Baseline to study completion (up to 135 days)|All-Treated Population for Phase II||kilograms||Standard Deviation|Mean
748567|NCT00536809|Secondary|Progression-free Survival (PFS) After Lapatinib, Oxaliplatin, and Capecitabine Administered at the MTD Level of Phase II|Both participants that entered Phase II of the study were censored for progression-free survival. Progression-free survival (PFS) is defined as the time from first dose until the first documented sign of disease progression or death due to any cause. For participants who do not progress or die, PFS was censored at the time of last radiological scan preceding the initiation of alternative anti-cancer therapy. Of the 2 participants in Phase II of the study, one discontinued due to adverse events, and the other was referred for a surgical resection.|Date of the first dose of study drug to the date of documented and confirmed progression by clinical, radiographic, or biochemical criteria, whichever occurred earliest, or to date of death due to any causes (up to 135 Days)|All-Treated Population for Phase II||days||Standard Deviation|Median
748568|NCT00536809|Secondary|Genetic Variants in Germline (Host) DNA and Comparison to the Efficacy and Safety of the Study Drugs|This outcome measure was conducted to investigate a possible genetic relationship to handling or response to lapatinib, oxaliplatin, and capecitabine. This measure was not analyzed due to the small number of participants who signed the optional pharmacogenetics consent.|Optional pharmacogenetics sample may be collected at any time during the study after consent has been obtained; however, it is recommended that it be collected at the earliest time point possible|Participants in the All-Treated Population who signed a PGx informed consent.||Number of variants per exon or gene|||Number
748569|NCT00536809|Secondary|Genetic Aberrations in Somatic (Tumor) DNA Derived From the Tumor Tissue Biopsies That May Associate With Clinical Outcomes in Response to Therapy|DNA sequencing was done to identify genetic aberrations in somatic (tumor) DNA that may associate with clinical outcomes in response to therapy. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.|Pre-treatment tumor sample should have been provided for the most recent biopsy (not older than 5 years) prior to dosing. The post-treatment sample is suggested, not mandatory, and should have been collected at end of Cycle 2, +/-3 days from Cycle 3.|All-Treated population for Phase II||Number of aberrations per exon or gene||Standard Deviation|Mean
748588|NCT00536913|Secondary|Forced Expiratory Volume in 1 Second (FEV1)|Changes in FEV1 from baseline to the mean value at 2 weeks to 4 weeks with the baseline value as a covariate.|At baseline, at 2 weeks and 4 weeks|||Liters||Full Range|Mean
748589|NCT00536913|Primary|Urinary Free Cortisol (UFC)|Ratio between the value at the end of treatment and the value at start of treatment, including only patients with values at both baseline and end of treatment|At baseline and 4 weeks|||Ratio||Full Range|Geometric Mean
748570|NCT00536809|Secondary|Tumor-derived Biomarkers (Encoded in Protein or RNA) Associated With Clinical Outcome to Treatment|Exploring tumor-derived biomarkers including TS, DPD, TP, EGFR (ErbB1), and additional downstream markers involved in the mechanism of action of each compound (e.g., ERCC1) and comparison to clinical response. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.|Pre-treatment tumor sample should have been provided for the most recent biopsy (not older than 5 years) prior to dosing. The post-treatment sample is suggested, not mandatory, and should have been collected at 43 +/-3 days.|All-Treated population for Phase II||Relative value comparison||Standard Deviation|Mean
748571|NCT00536809|Secondary|Effect of Lapatinib, Oxaliplatin, and Capecitabine on Plasma TS mRNA and the Relationship Between Plasma TS mRNA and Clinical Response|A possible association between a reduction in thymidylate synthase (TS) gene expression and increased sensitivity in clinical activity was to be explored. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.|Blood samples were collected to determine TS levels at screening phase; Days 43 and 85; after every 2 cycles of treatment (+/- 3 days); and at discontinuation (if possible).|All-Treated population for Phase II||Relative value comparison||Standard Deviation|Mean
748572|NCT00536809|Secondary|Relationship Between Pretreatment Plasma TS mRNA and Pretreatment Tumor TS mRNA in Colon Tumor Biopsies.|Exploring if there is an association with a reduction in thymidylate synthase (TS) gene expression in both plasma and tumor prior to treatment and increased sensitivity in clinical activity. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.|Plasma TS mRNA is collected at screening. Pre-treatment tumor sample can be archived tissue if collected within 5 years from screening; if not, tumor sample should be collected at screening.|All-Treated population for Phase II||Relative value comparison||Standard Deviation|Mean
748573|NCT00536809|Primary|Overall Response in Phase II|The overall response is defined as the number of participants whose tumor response was classified as a complete response (CR; disappearance of all target lesions) or partial response (PR; 30% decrease in the sum of the longest diameter of target lesions) per Response Evaluation Criteria in Solid Tumors. Response was measured for participants in Phase II only. To determine response, radiographic images were taken at baseline, 8 weeks, and every 8 weeks thereafter until the participant withdrew from the study.|Baseline to response (up to 135 days)|All-Treated Population for Phase II: all participants who received at least one dose of lapatinib||participants|||Number
748574|NCT00536874|Secondary|Specific Tumor Marker Response (Ca 19-9) to Neoadjuvant Therapy|Percent change in specific tumor marker (Cancer Antigen 19-9, Ca 19-9) levels in response to neoadjuvant therapy|Baseline and 2 years|||percent change||Full Range|Median
748575|NCT00536874|Secondary|Specific Tumor Marker Response (CEA) to Neoadjuvant Therapy|Percentage change in specific tumor marker (Carcinoembryonic antigen, CEA) levels in response to neoadjuvant therapy|Baseline and 2 years|||percent change||Full Range|Median
748576|NCT00536874|Secondary|Specific Tumor Marker Response (Ca 19-9) to Neoadjuvant Therapy||Baseline and 2 years|||U/ml||Full Range|Median
748577|NCT00536874|Secondary|RECIST Radiologic Response to Neoadjuvant Therapy|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR)=CR +PR|2 years|||participants|||Number
748578|NCT00536874|Secondary|Specific Tumor Marker Response (CEA) to Neoadjuvant Therapy||Baseline and 2 years|||ng/ml||Full Range|Median
748579|NCT00536874|Secondary|Overall Survival (Follow-Up Time)||From Baseline until 2 Years and Follow-Up, up to 120 months|||months||Full Range|Median
748580|NCT00536874|Primary|Overall Survival at 18 Months|Percentage of participants that were alive or survived at 18 months after randomization|18 months|||percentage of participants||95% Confidence Interval|Number
748581|NCT00536913|Secondary|Use of Rescue Medication at Day|Change in average value from the run-in to treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation.Missing data between the first and last entry estimated using linear interpolation.|Daily during run-in and daily during treatment period of 6 weeks|||Inhalations||Standard Deviation|Mean
748582|NCT00536913|Secondary|Use of Rescue Medication at Night|Change in average value from the run-in to treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation.Missing data between the first and last entry estimated using linear interpolation.|Daily during run-in and daily during treatment period of 6 weeks|||Inhalations||Standard Deviation|Mean
748583|NCT00536913|Secondary|Percentage of Nights With Awakenings Due to Asthma|Change in Percentage of nights with awakenings, average value from the run-in to treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation.Missing data between the first and last entry estimated using linear interpolation.|Daily during run-in and daily during treatment period of 6 weeks|||Percentage of nights||Standard Deviation|Mean
748584|NCT00536913|Secondary|Asthma Symptoms at Day|Change in average value from the run-in to treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation.Missing data between the first and last entry estimated using linear interpolation. Daily scale:0 = No symptoms; 1 = Mild symptoms; 2 = Moderate symptoms; 3 = Severe symptoms.|Daily during run-in and daily during treatment period of 6 weeks|||Units on a scale||Standard Deviation|Mean
748585|NCT00536913|Secondary|Asthma Symptoms at Night|Change in average value from the run-in to treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation.Missing data between the first and last entry estimated using linear interpolation. Daily scale:0 = No symptoms; 1 = Mild symptoms; 2 = Moderate symptoms; 3 = Severe symptoms.|Daily during run-in and daily during treatment period of 6 weeks|||Units on a scale||Standard Deviation|Mean
748586|NCT00536913|Secondary|Evening Peak Expiratory Flow (ePEF)|Change in average value from the run-in to the treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation. Missing data between the first and last entry were estimated using linear interpolation.|Daily during run-in and daily during treatment period of 6 weeks|||Liters/min||Standard Deviation|Mean
752636|NCT00561600|Secondary|Analysis of Metal Ion Release - Erythrocyte Cobalt|Erythrocyte Cobalt|4 months post-operative|Metal ion sub-study was limited to two sites. All participants with available data are presented below.||ug/L||Full Range|Median
748590|NCT00536978|Secondary|One-year Disease-free Survival (DFS)|Efficacy (disease-free-survival) defined as number of participants still living, without disease progression following T- cell or Natural killer (NK) cell adback. One-year disease-free survival (DFS) time estimated using the Kaplan-Meier estimator. Patients who experience disease recurrence considered to be a treatment failure event.|1 Year||||||
748591|NCT00536978|Primary|6-month Treatment Related Mortality (TRM)|Number of participant deaths in 6 months of T- cell or Natural killer (NK) cell adback treatment.|6 Months|Of the 22 patients enrolled, none received the adback T-Cell or NK cells treatment.||participants|||Number
748592|NCT00536991|Secondary|Objective Tumor Response, Assessed by RECIST|Judged by monthly physical exam and radiographic evaluation. Patients will be considered evaluable for tumor response if they have at least two post-baseline tumor assessments at least 4 weeks apart, received study medication for 8 weeks or if they have evidence of disease progression. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 11 years|All treated and eligible patients. 26 patients were not evaluable.||percentage of participants||95% Confidence Interval|Number
748593|NCT00536991|Secondary|Incidence of Toxicity Graded According to the National Cancer Institute CTC Version 3.0|Count of participants with serious adverse event. Please refer to the adverse event reporting for more detail.|Up to 11 years|All treated and eligible patients||Participants|||Count of Participants
748594|NCT00536991|Primary|PSA Response Rate|Patients will be considered evaluable for PSA response if they have at least two post-baseline PSA measurements at least 4 weeks apart, or if they have other evidence of disease progression. A PSA response will be considered a PSA decline of at least 50% must be confirmed by a second PSA value four or more weeks later. The reference PSA for these declines should be a PSA measured within 2 weeks prior to the initiation of therapy.|Up to 11 years|All treated and eligible patients||percentage of participants||95% Confidence Interval|Number
748595|NCT00536991|Primary|Determine the Maximum Tolerated Dose (MTD)|Determine the maximum tolerated dose (MTD) of oral calcitriol daily x 3 consecutive days a week in combination with oral ketoconazole (400 mg thrice daily [TID]) + oral hydrocortisone (20 mg AM, 10 mg PM)|up to 11 years|All Phase I participants||mcg|||Number
748596|NCT00537017|Primary|Number of Participants Who Experienced at Least One Adverse Event|An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. A serious adverse event is an adverse event that that results in death, life threatening adverse event, permanent or significant disability / unfitness for work, hospital treatment (i.e., admission to hospital) or prolongation of a patient's length of stay, or congenital deformity or birth defect.|Up to 42 weeks|All participants who received treatment with study drug were included in the analysis.||Participants|||Number
748597|NCT00537017|Secondary|Total Sleep Time|Participant diaries recorded time spent in the sleep state at half-hourly intervals for at least 3 full days before scheduled visits. BL was determined using two methods: 1) P04501 BL refers to the starting BL of the double-blind base study P04501 and 2) P04501 BL_LA refers to BL as defined by the last assessment taken in P04501. Endpoint refers to the last observed result for participants within P05175.|Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36|All participants with a baseline value and at least one post-baseline value were included in the analysis.||hours/day||Standard Deviation|Mean
748598|NCT00537017|Secondary|Absolute Duration of Dyskinesias|"Participant diaries recorded time spent in the on state with dyskinesias at half-hourly intervals for at least 3 full days before scheduled visits. “On” time is defined as when the participant’s medication is working as subjectively determined by the participant and his/her physician. Dyskinesias are a side effect of long-term therapy with L-dopa consisting of unintentional twisting and/or turning movements that occur in the on time. Higher values relative to BL signify worsening of dyskinesia (i.e., more time spent with dyskinesia). BL was determined using two methods: 1) P04501 BL refers to the starting BL of the double-blind base study P04501 and 2) P04501 BL_LA refers to BL as defined by the last assessment taken in P04501. Endpoint refers to the last observed result for participants within P05175."|Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36|All participants with a baseline value and at least one post-baseline value were included in the analysis.||hours/day||Standard Deviation|Mean
748599|NCT00537017|Secondary|"Time Spent in the on State Without Troublesome Dyskinesia"|"Participant diaries recorded time spent in the on state without troublesome dyskinesias at half-hourly intervals for at least 3 full days before scheduled visits. “On” time is defined as when the participant’s medication is working as subjectively determined by the participant and his/her physician. Dyskinesias are a side effect of long-term therapy with L-dopa consisting of unintentional twisting and/or turning movements that occur in the on time; troublesome dyskinesias interfere with function or cause discomfort. Higher values relative to BL signify that the Parkinson’s disease symptoms are better or absent (i.e., participant can move well) concomitant with absence of troublesome dyskinesias. BL was determined using two methods: 1) P04501 BL refers to the starting BL of the double-blind base study P04501 and 2) P04501 BL_LA refers to BL as defined by the last assessment taken in P04501. Endpoint refers to the last observed result for participants within P05175."|Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36|All participants with a baseline value and at least one post-baseline value were included in the analysis.||hours/day||Standard Deviation|Mean
748610|NCT00537056|Secondary|Tumor Size by DCE Magnetic Resonance Imaging (MRI) Scan|Tumor size was measured using values obtained from DCE MRI pre- and post-sunitinib therapy. Gadolinium contrast material given intravenously during the DCE MRI scan is used to improve visualization of blood vessels, tumors, and/or organs.|12 weeks|||Participants|||Count of Participants
748611|NCT00537056|Secondary|Tumor Size by Computed Tomography (CT) Scan|Tumor size was measured based on computed tomography (CT) pre- and post-sunitinib therapy. CT was performed immediately prior to the PET scan and is used to determine both the PET scan imaging area and PET image attenuation correction (AC). F-18 FDG PET provides the metabolic and physiologic data while CT provides the anatomical data.|12 weeks|||Participants|||Count of Participants
750372|NCT00552240|Secondary|Change in Glomerular Filtration Rate (GFR) From Baseline to Week 48|using 4-variable Modification of Diet in Renal Disease (MDRD) formula|baseline to week 48|Includes only treated patients with data for the specified time window||ml/min/1.73m^2||Standard Deviation|Mean
748600|NCT00537017|Secondary|"Time Spent in the on State With Troublesome Dyskinesias"|"Participant diaries recorded time spent in the on state with troublesome dyskinesias at half-hourly intervals for at least 3 full days before scheduled visits. “On” time is defined as when the participant’s medication is working as subjectively determined by the participant and his/her physician. Dyskinesias are a side effect of long-term therapy with L-dopa consisting of unintentional twisting and/or turning movements that occur in the on time; troublesome dyskinesias interfere with function or cause discomfort. Higher values relative to BL signify that the Parkinson’s disease symptoms are better or absent (i.e., participant can move well) concomitant with troublesome dyskinesias. BL was determined using two methods: 1) P04501 BL refers to the starting BL of the double-blind base study P04501 and 2) P04501 BL_LA refers to BL as defined by the last assessment taken in P04501. Endpoint refers to the last observed result for participants within P05175."|Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36|All participants with a baseline value and at least one post-baseline value were included in the analysis.||hours/day||Standard Deviation|Mean
748601|NCT00537017|Secondary|"Time Spent in the on State With no Dyskinesias"|"Participant diaries recorded time spent in the on state with no dyskinesias at half-hourly intervals for at least 3 full days before scheduled visits. “On” time is defined as when the participant’s medication is working as subjectively determined by the participant and his/her physician. Dyskinesias are a side effect of long-term therapy with L-dopa consisting of unintentional twisting and/or turning movements that occur in the on time. Higher values relative to BL signify an improvement in the Parkinson’s disease symptoms (i.e., participant can move well) concomitant with no dyskinesias. BL was determined using two methods: 1) P04501 BL refers to the starting BL of the double-blind base study P04501 and 2) P04501 BL_LA refers to BL as defined by the last assessment taken in P04501. Endpoint refers to the last observed result for participants within P05175."|Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36|All participants with a baseline value and at least one post-baseline value were included in the analysis.||hours/day||Standard Deviation|Mean
748602|NCT00537017|Secondary|"Awake Time Per Day in the on State"|"Participant diaries recorded time spent in the on state at half-hourly intervals for at least 3 full days before scheduled visits. “On” time is defined as when the participant’s medication is working as subjectively determined by the participant and his/her physician. Higher on time values relative to BL mean that the Parkinson’s disease symptoms are better or absent (i.e., participant can move well). BL was determined using two methods: 1) P04501 BL refers to the starting BL of the double-blind base study P04501 and 2) P04501 BL_LA refers to BL as defined by the last assessment taken in P04501. Endpoint refers to the last observed result for participants within P05175."|Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36|All participants with a baseline value and at least one post-baseline value were included in the analysis.||hours/day||Standard Deviation|Mean
748603|NCT00537017|Secondary|"Time Spent in Off State Per Day"|"Participant diaires recorded time spent in the off state at half-hourly intervals for at least 3 full days before scheduled visits. “Off” time is defined as when the participant’s medication is not working as subjectively determined by the participant and his/her physician. Higher off time values relative to Baseline (BL) signify that the Parkinson’s disease symptoms are worse (i.e., participant can only move slowly or not at all). BL was determined using two methods: 1) P04501 BL refers to the starting BL of the double-blind base study P04501 and 2) P04501 BL_LA refers to BL as defined by the last assessment taken in P04501. Endpoint refers to the last observed result for participants within P05175."|Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36|All participants with a baseline value and at least one post-baseline value were included in the analysis.||Hours/day||Standard Deviation|Mean
748604|NCT00537030|Secondary|Frequency of Asparaginase-related Toxicities Following Erwinase® Treatment.|As assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The incidence of these toxicities will be described. The percentage of patients that have Erwinase® therapy discontinued due to the above toxicities will also be estimated. With a sample size of 50, the incidence of the above toxicities can be estimated with a maximum standard error of 7%.|At each course of Erwinase® treatment||||||
748605|NCT00537030|Secondary|Presence of Anti-Erwinia Asparaginase Antibodies in Children Treated With a Course(s) of Erwinase® Following Clinical Allergy to PEG-asparaginase|An ELISA (enzyme-linked immunosorbent assay) method will be used to determine the presence of specific anti-Erwinia and anti-PEG-asparaginase antibodies at baseline, and of specific anti-Erwinia asparaginase antibodies after first and subsequent exposures to Erwinase®. The rate of antibody formation will be described and compared informally to experience in CCG-1962 and 1961. Serum asparaginase activity will be compared during Erwinase® courses as an indication of the neutralizing effect of antibodies on the enzyme effect.|At baseline, prior to doses 4, 5, and 6 and on days 15 and 22||||||
748606|NCT00537030|Secondary|Determine if Plasma Asparagine is Adequately Depleted|Plasma asparagine depletion will be determined in a subset of 20 patients limited to participating Phase I Institutions.|On days 12 or 13||||||
748607|NCT00537030|Primary|Trough Serum Asparaginase Activity|To determine if the 48 hour trough serum asparaginase activity is ≥ 0.1 IU/mL in at least 70% of patients.|Measured in blood at 48 hours post administration of Erwinia asparaginase|Of the 59 enrolled participants, there was 1 ineligible participant and 3 inevaluable participants that were not analyzed leaving a total of 55 participants. Of those 55 participants, 20 participants had an insufficient sample at 48 hours, where a total of 35 participants were analyzed.||IU/mL of Asparaginase Activity||Full Range|Median
748608|NCT00537056|Secondary|Initial Tumor Size|Initial tumor size was measured using values obtained from computed tomography (CT) pre-sunitinib therapy. CT is performed immediately prior to the PET scan and is used to determine both the PET scan imaging area and PET image attenuation correction (AC). F-18 FDG PET provides the metabolic and physiologic data while CT provides the anatomical data.|pre-sunitinib therapy|||Participants|||Count of Participants
748609|NCT00537056|Secondary|DCE MRI AUC Peak Flow|Area under the curve (AUC) was measured using receiver operating characteristic (ROC) curve analysis. ROC curve analysis measures sensitivity (true-positives, correctly diagnosed positive pathologies) against specificity (true-negatives, correctly diagnosed negative pathologies or free of disease) of the DCE MRI scan. An area of 1.0 under the curve would equal a perfect test (with 100% sensitivity; 100% specificity) while an area of 0.5 would equal a useless test (50% sensitivity; 50% specificity).|12 weeks|||Participants|||Count of Participants
748612|NCT00537056|Secondary|Tumor Necrosis|The degree of tumor necrosis was measured using values obtained from dynamic contrast enhanced magnetic resonance imaging (DCE MRI) pre- and post-sunitinib therapy. Gadolinium contrast material given intravenously during the DCE MRI scan is used to improve visualization of blood vessels, tumors, and/or organs.|12 weeks|||Participants|||Count of Participants
748613|NCT00537056|Secondary|Adverse Events|Adverse events were monitored for on F-18 FDG PET/CT and DCE MRI imaging days: baseline (n=17); interim (n=12); and post-sunitinib therapy (n=17). Reported as the overall number of adverse events experienced.|up to 12 months|||adverse events|||Number
748614|NCT00537056|Secondary|Initial Comprehensive Metabolic Panel|A comprehensive metabolic panel is a blood test that measures sugar (glucose) level, electrolyte and fluid balance, kidney function, and liver function. It was performed prior to the administration of gadolinium contrast. For patients with normal renal function, approximately 90% of gadolinium contrast is excreted through the urinary system. These patients have known renal cell carcinoma, so it was important to perform a metabolic function panel prior to gadolinium injection, specifically to determine kidney function. Reported as the number of patients for whom the initial comprehensive metabolic panel was within institutional standards.|Prior to baseline DCE MRI|||Participants|||Count of Participants
748615|NCT00537056|Secondary|Histopathology|Histopathologic findings were correlated to the pre-treatment 18F-fluorodeoxyglucose positron emission tomography (F-18 FDG PET/CT) scan. Outcome is reported as the number of participants for whom both histopathology and F-18 FDG PET/CT indicated that active cancers was present.|1 day|Patients with renal cell carcinoma||Participants|||Count of Participants
748616|NCT00537056|Primary|F-18 FDG Tumor Uptake (SUV Max)|"The maximum standardized uptake value (SUVmax) is a measurement of tumor metabolism as determined by the PET scan before and after 12-weeks of sunitinib therapy. Decreased SUVmax correlates to a reduction of tumor metabolism. Increased SUVmax correlates to an increase in tumor metabolism.
Reduction or increased SUVmax will be determined as the change from baseline in uptake of F18 FDG.
Results were based on the European Organization for Research and Treatment of Cancer (EORTC) for predicting progression free survival. EORTC criteria is a ± 25% change of SUVmax for assessment of progressive disease, stable disease and partial response."|12 weeks minus baseline|All patients underwent baseline F-18 FDG PET scan. Mean SUVmax at baseline is reported (row 1). 6 participants achieved progression-free survival after post-sunitinib therapy, and their SUVmax values were averaged (row 2). 11 participants had progression or recurrence/relapse of disease and their SUVmax values were averaged (row 3).||SUVmax||Standard Deviation|Mean
748617|NCT00537082|Secondary|Annualized Relapse Rate (ARR) at 6 Months|Annualized relapse rate (ARR) of the treatment group is calculated by taking the total number of confirmed relapses for all the patients in the treatment group divided by the total number of days on study for all patients in the group and multiplied by 365.25 to obtain the annual rate.|6 Months|Full Analysis Set (FAS) consisted of all patients who were randomized and received at least one dose of study drug. This population was only used for the analyses of relapse and EDSS.||Relapses per year|||Number
748618|NCT00537082|Secondary|Number of Patients Free of New or Newly Enlarged T2 Lesions|The number of T2 lesions were obtained from MRI scans at Screening visit. The numbers of new/newly enlarging T2 lesions were obtained from MRI scans at Month 3 or more. New lesions were identified by comparing each lesion already seen in previous examinations. Lesions expanding throughout several slices were counted as only one lesion.|up to Month 3 and up to Month 6|Modified Full Analysis Set (Modified FAS) included all patients who were randomized and received at least one dose of study drug and had at least one valid post-randomized MRI scan at Month 3 or longer.||Participants|||Number
748619|NCT00537082|Secondary|Number of Patients Free of MS Relapse up to Month 6 (Confirmed Relapse Only)|A relapse must have been confirmed by a neurologist and was confirmed when it was accompanied by an increase of at least half a step (0.5) on the Expanded Disability Status Scale (EDSS) or an increase of 1 point on two different Functional Systems (FS) of the EDSS or 2 points on one of the FS (excluding Bowel/Bladder or Cerebral FS).|up to Month 6|Full Analysis Set (FAS) consisted of all patients who were randomized and received at least one dose of study drug. This population was only used for the analyses of relapse and EDSS.||Participants|||Number
748620|NCT00537082|Primary|Number of Patients Free of Gadolinium-enhanced T1-Weighted Magnetic Resonance Imaging (MRI) Lesions at Both Month 3 and Month 6|Brain Magnetic Resonance Imaging (MRI) was performed at Month 3 and Month 6. Gadolinium-enhancing lesions (active lesions) represent acute inflammatory activity only and dissipate within 2-8 weeks of appearance. MRI scans were analyzed by blinded readers at the central MRI Evaluation Center to ensure consistency. Any Gd-enhanced T1 weighted MRI data obtained less than 14 days after the steroid used to treat MS relapses is invalid and excluded.|Month 3 and Month 6|Modified Full Analysis Set (Modified FAS) included all patients who were randomized and received at least one dose of study drug and had at least one valid post-randomized MRI scan at Month 3 or longer.||Participants|||Number
748621|NCT00537095|Secondary|Time to Death|Interim analysis time to date of randomisation to date of death (data not mature at the time of this analysis, so number of deaths displayed instead.|time from randomisation to date of death|For the efficacy part, 72 were randomized to received ZD6474 and 73 placebo. For the safety part, 73 patients received at least one dose of ZD6474 and 72 placebo||participants|||Number
748622|NCT00537095|Secondary|Objective Response Rate|Best objective response of the participants from an average of 46.7 months, defined as complete or partial response according to RECIST criteria|46.7 months|||participants|||Number
748623|NCT00537095|Secondary|Disease Control Rate at 6 Months|number of participants that achieved disease control 6 months after randomisation. Best objective response of complete response + partial response + stable disease > 24 weeks according to RECIST criteria|6 months after randomisation|||participants|||Number
748624|NCT00537095|Primary|Time to Tumor Progression|modified RECIST V1.0 was used|Time from date of randomisation to date of the first documented tumor progression or date of death from any cause (within the 3 months) of tumor assessment|||days||95% Confidence Interval|Median
748634|NCT00537277|Secondary|Number of Treatment Emergent Serious Adverse Events (SAEs)|Total number of treatment emergent SAEs experienced from baseline (week 0) to end of trial (week 48). A treatment emergent SAE were defined as an adverse event which occurred in the trial treatment period.|weeks 0-48|Safety analysis set was all subjects who have been exposed to at least one dose of trial drug.||events|||Number
755298|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for ‘Psychiatric’||28 days|Safety Set, only patients with non-missing values were analyzed||participants|||Number
748625|NCT00537199|Primary|Ratio (Percentage) of Sensitivity of OraTest + Visual Exam Versus Sensitivity of Visual Exam Alone|"Primary efficacy parameters, ratio of sensitivity of OraTest® in combination with visual exam versus visual exam alone is the difference between the adjusted specificity for OraTest in combination with visual exam and the adjusted specificity for visual exam alone.
Reported ratio as percentage of patients with abnormalities (suspicious lesions) found upon visual exam of the mouth with and without OraTest® dye."|Following two (2) scheduled visits for visual examination, up to one month following first exam|No analysis was performed. Study was terminated by sponsor.|||||
748626|NCT00537238|Secondary|Percentage of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) Score|MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Percentage of participants with optimal sleep are reported.|Baseline, Week 16|FAS included all randomized participants who had received at least 1 blinded dose of study drug and had at least 1 baseline and post baseline primary efficacy evaluation. N (number of participants analyzed)=participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||percentage of participants|||Number
748627|NCT00537238|Secondary|Medical Outcomes Study Sleep Scale (MOS-SS) Score|Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales:sleep disturbance,snoring,awakened short of breath,sleep adequacy,somnolence (range:0-100);sleep quantity (range:0-24),optimal sleep(yes/no), and 9 item index measures of sleep disturbance provide composite scores:sleep problem summary,overall sleep problem. Except adequacy,optimal sleep and quantity, higher scores=more impairment. Scores transformed (actual raw score[RS] minus lowest possible score divided by possible RS range*100);total score range:0-100;higher score=more intensity of attribute.|Baseline, Week 16|FAS included all randomized participants who had received at least 1 blinded dose of study medication and had at least 1 baseline and post baseline primary efficacy evaluation. n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Error|Least Squares Mean
748628|NCT00537238|Secondary|Hospital Anxiety and Depression Scale (HADS) Score|HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.|Baseline, Week 16|FAS included all randomized participants who had received at least 1 blinded dose of study drug and had at least 1 baseline and post baseline primary efficacy evaluation. N (number of participants analyzed)=participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Error|Least Squares Mean
748629|NCT00537238|Secondary|Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total and Core Score at Week 7, 10, 13, 16 and Follow-up|BPRS-A:18-item clinician rated scale assesses somatic concern,anxiety, emotional withdrawal,conceptual disorganization,hallucinatory behavior(HB), guilt feelings,suspiciousness,disorientation,tension,mannerisms and posturing,grandiosity,depressive mood,hostility,motor retardation,uncooperativeness,unusual thought content,blunted affect,excitement. Items rated on 7-point scale 1 (not reported) to 7 (very severe). Total score=sum of items(range 18-126), core score=sum of conceptual disorganization, suspiciousness, HB, unusual thought content(range 4-28). Higher total/core score=more impairment.|Baseline, Week 7, 10, 13, 16 and Follow-up (Day 7 of taper phase)|FAS included all randomized participants who had received at least 1 blinded dose of study drug and had at least 1 baseline and post baseline primary efficacy evaluation. n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Error|Least Squares Mean
748630|NCT00537238|Secondary|Percentage of Participants Without Seizures|Seizure free for 28 days was defined as participants who have not experienced any seizure (simple partial, complex partial and SGTC) for at least 28 consecutive days from their last seizure until the end of the maintenance phase. Same participant could be seizure free for a specific type of seizure but not necessarily for the other types of seizure.|Baseline up to Week 16|FAS included all randomized participants who had received at least 1 blinded dose of study drug and had at least 1 baseline and post baseline primary efficacy evaluation. N (number of participants analyzed)=participants who were evaluable for this measure.||percentage of participants||95% Confidence Interval|Number
748631|NCT00537238|Secondary|Change From Baseline in the Proportion of 28-day Secondarily Generalized Tonic-clonic (SGTC) Seizure Rate to 28-day All Partial Seizure Rate at Week 16|Change was calculated as (proportion of SGTC seizure rate divided by all partial seizure rates during double blind phase) minus (proportion of SGTC seizure rate divided by all partial seizure rates at baseline). Negative values indicated reductions in seizures.|Baseline, Week 16|SGTC population included all participants who had at least 1 SGTC seizure during either baseline or double-blind phase. n=number of participants evaluable at specific time points for each arm group, respectively.||percentage of all partial seizure/28days||Standard Deviation|Mean
748632|NCT00537238|Secondary|Percent Change From Baseline in 28 Day Seizure Frequency at Week 16|The seizures were recorded by the participants, by a family member, by a caregiver, or by a legal guardian and documented in a daily seizure diary. Participant’s 28-day seizure frequency of all partial seizure was assessed during double blind (TP + MP) phase compared with baseline.|Baseline, Week 16|Full analysis set (FAS) included all randomized participants who had received at least 1 blinded dose of study drug and had at least 1 baseline and post baseline primary efficacy evaluation.||percent change||Full Range|Median
748633|NCT00537238|Primary|Proportion of Participants With Response to Treatment|Participants who had at least 50% reduction in 28-day seizure rate from baseline to the end of the maintenance phase were considered as responders. The 28-day seizure rate was calculated as number of partial seizures in the period divided by difference of number of days in the period and number of missing diary day entries in the period, multiplied by 28.|Baseline up to Week 16|Per protocol population included all randomized participants who had at least 28 days of study drug during the maintenance phase and a minimum of 28 days of utilizable seizure diary data during baseline and maintenance phases of the study and had no major protocol violation.||proportion of participants|||Number
748635|NCT00537277|Secondary|Number of Nocturnal Hypoglycaemic Episodes|Total number of hypoglycaemic episodes during the night (nocturnal) experienced in the trial from baseline (week 0) to end of trial (week 48). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose (PG) below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no PG or blood glucose measurement or PG higher than or equal to 3.1 mmol/L or 56 mg/dL.|weeks 0-48|Safety analysis set was all subjects who have been exposed to at least one dose of trial drug.||episodes|||Number
748636|NCT00537277|Secondary|Number of Diurnal Hypoglycaemic Episodes|Total number of hypoglycaemic episodes during the day (diurnal) experienced in the trial from baseline (week 0) to end of trial (week 48). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose (PG) below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no PG or blood glucose measurement or PG higher than or equal to 3.1 mmol/L or 56 mg/dL.|weeks 0-48|Safety analysis set was all subjects who have been exposed to at least one dose of trial drug.||episodes|||Number
748637|NCT00537277|Secondary|Number of Hypoglycaemic Episodes|Total number of hypoglycaemic episodes experienced from baseline (week 0) to end of trial (week 48). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose (PG) below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no PG or blood glucose measurement or PG higher than or equal to 3.1 mmol/L or 56 mg/dL.|weeks 0-48|Safety analysis set was all subjects who have been exposed to at least one dose of trial drug.||episodes|||Number
748638|NCT00537277|Secondary|Percentage of Trial Completers Achieving the Treatment Target of Glycosylated Haemoglobin (HbA1c) Below 7.0%||week 48|Full Analysis Set (FAS) was all subjects who have been exposed to at least one dose of trial drug.||percentage of trial completers|||Number
748639|NCT00537277|Primary|Percentage of Subjects Achieving the Treatment Target of Glycosylated Haemoglobin (HbA1c) Below 7.0%||week 48|Full Analysis Set (FAS) was all subjects who have been exposed to at least one dose of trial drug.||percentage of subjects|||Number
748640|NCT00537303|Secondary|Cardiovascular Risk Marker: High-sensitivity C-reactive Peptide|High-sensitivity C-reactive peptide was measured in serum at week 36. Serum samples were analysed at a central laboratory.|week 36|Safety Analysis Set is all randomised subjects exposed to at least one dose of trial products.||mg/L||Standard Deviation|Mean
748641|NCT00537303|Secondary|Haematology: Haemoglobin Measured in Blood|Haemoglobin was measured in blood samples at week 36. Blood samples were analysed at a central laboratory.|week 36|Safety Analysis Set is all randomised subjects exposed to at least one dose of trial products.||mmol/L||Standard Deviation|Mean
748642|NCT00537303|Secondary|Biochemistry: Serum Alanine Aminotransferase|Alanine aminotransferase was measured in serum at week 36. Serum samples were analysed at a central laboratory.|week 36|Safety Analysis Set is all randomised subjects exposed to at least one dose of trial products.||U/L||Standard Deviation|Mean
748643|NCT00537303|Secondary|Hypoglycaemic Episodes|Number of hypoglycaemic episodes from Week 0 to Week 36, defined as major, minor or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L (56 mg/dL). Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|Weeks 0-36|Safety Analysis Set is all randomised subjects exposed to at least one dose of trial products.||episodes|||Number
748644|NCT00537303|Primary|Glycosylated Haemoglobin A1c (HbA1c)|Measured for the Per Protocol analysis set.|week 36|Per Protocol analysis set: All exposed subjects who completed the trial without significantly violating the inclusion/exclusion criteria or other aspects of the protocol considered to potentially affect the efficacy results.||percentage (%) of total haemoglobin||Standard Error|Least Squares Mean
748645|NCT00537303|Primary|Glycosylated Haemoglobin A1c (HbA1c)|Analysed for the full analysis set.|week 36|Full analysis set (FAS) is all randomised subjects exposed to at least one dose of trial products.||percentage (%) of total haemoglobin||Standard Error|Least Squares Mean
748689|NCT00537407|Secondary|log10 Hepatitis C Virus RNA at Day 29|Hepatitis C virus RNA was quantified in plasma samples using real time polymerase chain reaction.|Day 29|Intent-to-treat population: All randomized participants with at least a Baseline and 1 on- or post-treatment hepatitis C virus RNA assessment.||Log10(IU/mL)||Standard Deviation|Mean
748652|NCT00537329|Secondary|Number of Subjects With Global Response of Success at EOT in Relation to Subject Subgroups|Number of subjects with clinician assessed global response of success at EOT (clinical=cure, improvement, microbiological=eradication, presumed eradication) in relation to subject subgroups (subject may be represented in >1 subgroup). Subgroups: Neutropenic status (absolute neutrophil count [ANC in cubic millimeters [cmm]); baseline pathogen; previous surgery (any surgery, abdominal surgery); organ transplantation (kidney, liver, heart); elderly; renal insufficiency (calculated creatinine clearance [CCC] in milliliters per minute [mL/min]); central venous catheter; receiving chemotherapy.|EOT (Day 5 up to Day 42)|MITT. May have >1 baseline pathogen; previous surgery=any surgery (includes abdominal surgery) within 1 month prior to baseline (PTB); chemotherapy for solid cell tumors or hematological malignancies at baseline or within 3 months PTB; central venous catheter (CVC) up to 1 month PTB; (n)=subjects per subgroup with analyzable data at observation.||participants|||Number
748653|NCT00537329|Secondary|Change From Baseline for β-D-glucan Assay Results at Endpoints in Relation to Microbiological Response of Status of Success or Status of Failure at EOT|Change from baseline in β-D-glucan (range 0 to 6000 pg/mL) summarized at endpoints and by subject’s EOT microbiological response status of Success at EOT or Failure at EOT and as combined status of All at EOT. Success=eradication (negative culture Candida spp or presumed eradication (culture not available, clinical outcome defined as success); failure=persistence (culture positive for at least 1 baseline Candida spp) or presumed persistence (culture not available, clinical outcome defined as failure). Percent change=([mean value of β-D-glucan at observation-baseline value]/baseline value*100).|Baseline, Day 3, Day 5, Day 7, EOT (Day 5 up to Day 42)|"MITT; (n)=number of subjects with analyzable data at observation; summary includes only subjects who completed visit; missing microbiological responses treated as failures. Failures carried forward for subjects who withdrew prematurely from study with documented failure. All category includes all subjects with success or failure at EOT."||percent change||Standard Deviation|Mean
748654|NCT00537329|Secondary|Absolute Values for β-D-glucan Assay Results at Endpoints in Relation to Microbiological Response Status of Success or Status of Failure at End of All Treatment|Absolute values for β-D-glucan (range 0 to 6000 pg/mL) summarized at timeframe endpoints by subject’s at end of all treatment microbiological response status of Success at EOT or Failure at EOT and as combined status of All at EOT. Success: eradication (follow up negative culture for Candida spp) or presumed eradication (follow up culture was not available and clinical outcome defined as success); failure: persistence (follow up culture was positive for at least 1 baseline Candida spp) or presumed persistence (follow up culture was not available and clinical outcome was defined as failure).|Baseline, Day 3, Day 5, Day 7, EOT (Day 5 up to Day 42)|"MITT; (n)=number of subjects with analyzable data at observation; summary includes only subjects who completed visit; missing microbiological responses treated as failures. Failures carried forward for subjects who withdrew prematurely from study with documented failure. All category includes all subjects with success or failure at EOT."||pg/mL||Standard Deviation|Mean
748655|NCT00537329|Secondary|Change From Baseline for β-D-glucan Assay Results at Endpoints in Relation to Clinical Response Status of Success or Status of Failure at End of All Treatment|Change from baseline for β-D-glucan (range 0 to 6000 pg/mL) summarized at endpoints by subject's at end of all treatment clinical response status of Success at EOT or Failure at EOT and as combined status of All at EOT. Success=cure (resolution of signs, symptoms of Candida infection) or improvement (significant but incomplete resolution of signs, symptoms); failure=no significant improvement or death due to Candida infection; subject must have received at least 3 doses of anidulafungin. Percent change calculated as ([mean value of β-D-glucan at observation-baseline value]/baseline value*100).|Baseline, Day 3, Day 5, Day 7, EOT (Day 5 up to Day 42)|"MITT; (n)=number of subjects with analyzable data at observation; summary includes only subjects who completed visit; missing or indeterminate CR treated as failures. Failures were carried forward for subjects who withdrew prematurely from study with a documented failure. All category includes all subjects with success or failure at EOT."||percent change||Standard Deviation|Mean
748656|NCT00537329|Secondary|Absolute Values for β-D-glucan Assay Results at Endpoints in Relation to Clinical Response Status of Success or Status of Failure at End of All Treatment|Absolute values for β-D-glucan (range 0 to 6000 picograms per milliliter [pg/mL]) summarized at all timeframe endpoints by subject’s at end of all treatment clinical response status of success (Success at EOT) or failure (Failure at EOT) and as combined status of all subjects (All at EOT). Success: cure (resolution of signs and symptoms of Candida infection) or improvement (significant but incomplete resolution of signs and symptoms); failure: no significant improvement in signs and symptoms or death due to Candida infection; subjects must have received at least 3 doses of anidulafungin.|Baseline, Day 3, Day 5, Day 7, EOT (Day 5 up to Day 42)|"MITT; (n)=number of subjects with analyzable data at observation; summary includes only subjects who completed visit; missing or indeterminate CR treated as failures. Failures were carried forward for subjects who withdrew prematurely from study with a documented failure. All category includes all subjects with success or failure at EOT."||pg/mL||Standard Deviation|Mean
748657|NCT00537329|Secondary|Time to Death Due to Candidemia|"Time to death (median survival time in days) due to candidemia; time to death includes the first day (Day 1) of study drug (baseline and Day 1 allowed to occur on same day). EOT visit could occur anytime from Day 5 through Day 42; if a subject terminated early, the timeframe at end of 12 weeks after baseline could occur in the follow-up period (6 Wks post EOT or Week 12 post EOT)."|Baseline through end of 12 weeks after baseline|MITT; time to death (median survival time in days) based on Kaplan-Meier method if estimable. Data not summarized by median survival time as planned as median time is not estimable; no subjects died due to candidemia out of the analyzable population.||days||Full Range|Median
755606|NCT00597558|Secondary|Egg Protein Skin Prick Test After Egg OIT|Wheal size on egg protein skin prick test at the end of egg OIT treatment compared with at baseline.|24-60 months|||mm||Full Range|Mean
748658|NCT00537329|Secondary|Time to Death From Any Cause|"Time to death (median survival time in days) from any cause; time to death includes the first day (Day 1) of study drug (baseline and Day 1 allowed to occur on same day). EOT visit could occur anytime from Day 5 through Day 42; if a subject terminated early, the timeframe at end of 12 weeks after baseline could occur in the follow-up period (6 Wks post EOT or Week 12 post EOT)."|Baseline through end of 12 weeks after baseline|MITT; time to death (median survival time in days) based on Kaplan-Meier method if estimable. Data not summarized by median survival time as planned as median time is not estimable; < 50% of subjects died out of the analyzable population.||days||Full Range|Median
748659|NCT00537329|Secondary|Number of Subjects With Microbiological Response of Success at Endpoints|Number of subjects with clinician assessed microbiological response (MR) of success. Defined as eradication or presumed eradication (erad/presumed erad): erad=follow up negative culture result for Candida spp; presumed eradication=follow up culture was not available and clinical outcome defined as success on the microbiological response.|EOIT, EOT (Day 5 up to Day 42), 2 Wks post EOT, 6 Wks post EOT, 12 Wks post baseline|"MITT. EOT visit could occur anytime from Day 5 through Day 42; if a subject terminated early, the timeframe at end of 12 weeks after baseline could occur in the follow-up period (6 Wks post EOT or Week 12 post EOT)."||participants|||Number
748660|NCT00537329|Secondary|Number of Subjects With Clinical Response of Success at Endpoints|Number of subjects with clinician assessed clinical response (CR) of success. Defined as cure or improvement (cure/improvement): cure=resolution of signs and symptoms of Candida infection; improvement=significant but incomplete resolution of signs and symptoms of Candida infection on the clinical response.|EOIT, EOT (Day 5 up to Day 42), 2 Wks post EOT, 6 Wks post EOT, 12 Wks post baseline|"MITT. EOT visit could occur anytime from Day 5 through Day 42; if a subject terminated early, the timeframe at end of 12 weeks after baseline could occur in the follow-up period (6 Wks post EOT or Week 12 post EOT)."||participants|||Number
748661|NCT00537329|Secondary|Number of Subjects With Global Response of Success at Endpoints|Number of subjects with clinician assessed global response of success. Defined as cure or improvement (cure/improvement): cure=resolution of signs and symptoms of Candida infection; improvement=significant but incomplete resolution of signs and symptoms of Candida infection on the clinical response in conjunction with eradication or presumed eradication (erad/presumed erad): erad=follow up negative culture result for Candida spp; presumed erad=follow up culture was not available and clinical outcome defined as success on the microbiological response.|End of intravenous treatment (EOIT), end of Week 2 after EOT (2 Wks post EOT), end of Week 6 after EOT (6 Wks post EOT), at end of 12 weeks after baseline (12 Wks post baseline)|"MITT; EOT visit could occur anytime from Day 5 through Day 42; if a subject terminated early, the timeframe at end of 12 weeks after baseline could occur in the follow-up period (6 Wks post EOT or Week 12 post EOT)."||participants|||Number
748662|NCT00537329|Primary|Number of Subjects With Global Response of Success at End of Treatment|Number of subjects with clinician assessed global response of success; defined as cure (resolution of signs and symptoms of Candida infection) or improvement (significant but incomplete resolution of signs and symptoms of Candida infection) on the clinical response in conjunction with eradication (follow up negative culture result for Candida species [spp]) or presumed eradication (follow up culture was not available and clinical outcome defined as success) on the microbiological response.|End of treatment (EOT) = Day 5 up to Day 42|Modified Intent to Treat (MITT): includes all Full Analysis Set (FAS) subjects (received at least 1 dose of study treatment) with confirmed, documented diagnosis of candidemia and had received the initial loading dose of study treatment.||participants|||Number
748663|NCT00537381|Secondary|Percent Change From Baseline in ‘Vascular Endothelial Growth Factor (VEGF)’ Marker Concentration|Percent change = marker concentration at time of measurement minus baseline value divided by baseline value multiplied by 100.|Baseline, Week 6, 7, 10 and 13|The PD analysis set included all participants who received at least 1 dose of study treatment and had at least 1 PD measurement. Here ‘n’ signifies those participants evaluable for this measure at the specified time point for each arm group, respectively.||Percent change||Standard Deviation|Mean
748664|NCT00537381|Secondary|Percent Change From Baseline in ‘N-telopeptide of Type I Collagen (NTx)’ Marker Concentration|Percent change = marker concentration at time of measurement minus baseline value divided by baseline value multiplied by 100.|Baseline, Week 6, 7, 10 and 13|The PD analysis set included all participants who received at least 1 dose of study treatment and had at least 1 PD measurement. Here ‘n’ signifies those participants evaluable for this measure at the specified time point for each arm group, respectively.||Percent change||Standard Deviation|Mean
748665|NCT00537381|Secondary|Percent Change From Baseline in ‘C-telopeptide of Type I Collagen (CTx)’ Marker Concentration|Percent change = marker concentration at time of measurement minus baseline value divided by baseline value multiplied by 100.|Baseline, Week 6, 7, 10 and 13|The pharmacodynamic (PD) analysis set included all participants who received at least 1 dose of study treatment and had at least 1 PD measurement. Here ‘n’ signifies those participants evaluable for this measure at the specified time point for each arm group, respectively.||Percent change||Standard Deviation|Mean
748666|NCT00537381|Secondary|Overall Survival|Overall Survival is defined as the time from the date of randomization to death due to any cause. For participants who were alive at the time of analysis, overall survival was censored at the last contact date.|Baseline until death (up to 887 days)|Efficacy population included all participants randomly assigned to study treatment.||Days||95% Confidence Interval|Median
748667|NCT00537381|Secondary|Number of Participants With Prostate Specific Antigen (PSA) Response|The PSA response is defined as at least a 50 percent decrease in PSA below the baseline value, confirmed by a second PSA value greater than or equal to 6 weeks later. A participant was considered to be a PSA responder if and only if the response occurs prior to PSA progression (increase of at least 25 percent and an increase of 5 nanogram per milliliter from the lowest observed PSA value since initiation of treatment, to be confirmed greater than or equal to 3 weeks later).|Baseline up to 6 months after last dose of study treatment or early withdrawal, assessed up to 601 days|Included all participants randomly assigned to study treatment and had baseline PSA evaluation and at least two post-baseline evaluations that are at least 3 weeks apart.||Participants|||Number
748690|NCT00537407|Secondary|Change From Baseline in log10 Hepatitis C Virus RNA at Day 29 in the Debio 025 Monotherapy and Dual Therapy Treatment Arms (B and C)|Hepatitis C virus RNA was quantified in plasma samples using real time polymerase chain reaction.|Baseline to Day 29|Intent-to-treat population: All randomized participants with at least a Baseline and 1 on- or post-treatment hepatitis C virus RNA assessment.||Log10(IU/mL)||Standard Deviation|Mean
748668|NCT00537381|Secondary|Number of Participants With Best Overall Response (OR)|Number of participants with best OR is based on assessment of confirmed complete response (CR) or confirmed partial response (PR). Confirmed CR is defined as disappearance of all target lesions. Confirmed PR is defined as greater than or equal to 30 percent decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD. Confirmed responses are those that persist on repeat imaging study greater than or equal to 4 weeks after initial documentation of response.|Baseline up to 6 months after last dose of study treatment, assessed up to 551 days|Response evaluable population included participants who had target lesion or non-target lesion at baseline and received at least 1 study treatment and had at least 1 post-baseline response assessment or discontinued study treatment due to disease progression, or death.||Participants|||Number
748669|NCT00537381|Primary|Progression-Free Survival (PFS)|The PFS was assessed as median number of days from baseline until the first documented sign of disease progression (increase in disease; radiographic, clinical, or both) or death due to any cause, whichever occurred earlier.|Baseline up to 6 months after last dose of study treatment, assessed up to 551 days|Efficacy population included all participants randomly assigned to study treatment.||Days||95% Confidence Interval|Median
748670|NCT00537394|Secondary|Participants With Newly Acquired HIV Drug Resistance Between Study Entry and Confirmed Virologic Failure|Defined among the subgroup of participants experiencing the outcome of confirmed virologic failure. Newly acquired HIV drug resistance is defined as one or more ARVs with partial resistance or resistance when pre-entry resistance was fully sensitive or resistant when pre-entry resistance was fully sensitive or partially sensitive. The ARVs included for resistance acquisition included the following: darunavir/ritonavir; etravirine, tipranavir, tenofovir, emtracitabine, lamivudine, zidovudine, abacavir.|Between baseline and confirmed virologic failure (up to 96 weeks)|Those with confirmed virologic failure (N=54; N=50) among the randomized arms included; and those who were missing resistance information following virologic failure (N=2; N=4) are excluded.||participants|||Number
748671|NCT00537394|Secondary|Change in Fasting Non-HDL Cholesterol From Baseline|Fasting non-HDL cholesterol calculated from difference between fasting total cholesterol and fasting HDL level. Missing values and non-fasting values excluded.|From study entry to Weeks 24, 48|All randomized participants who started study treatment. Non-fasting results and missing results excluded from analysis. Therefore, differences reported here represent a complete case analysis.||mg/dL||Standard Deviation|Mean
748672|NCT00537394|Secondary|Number of Participants With Change in Virus Co-receptor Tropism Among Those With R5-only Tropic Virus at Study Entry|HIV Co-receptor tropism test result of either dual/mixed or evidence of X4 using virus from sample collected at confirmed virologic failure.|From study entry to time of confirmed virological failure (up to 96 weeks)|Only randomized participants with R5-tropic virus at study entry (N=89; N=88), and who experienced confirmed virologic failure (N=27; N=22) during follow-up, and who had a tropism test following failure are included.||participants|||Number
748673|NCT00537394|Secondary|Time From Treatment Dispensation to Serious Non-AIDS-defining Events|Serious Non-AIDS defining Events were adjudicated by independent and blinded review and possible events included serious diagnoses in the following disease areas: liver, cardiovascular, end-stage renal, non-AIDS malignancy, and diabetes mellitus. Week 96 study visit could take place up to 110 weeks following randomization. Event times were the exact weeks following treatment initiation corresponding to the diagnosis dates of the qualifying serious non-AIDS defining events. Censoring times were the weeks following treatment initiation corresponding to the latest study visit.|From treatment initiation to week 96 study visit|Randomized participants were included, and those not starting study treatment were excluded.||weeks||95% Confidence Interval|Number
748674|NCT00537394|Secondary|Change in CD4 Count From Baseline|Baseline CD4 calculated as average of pre-entry and entry values. Closest observed result between 42 and up to 54 weeks (for week 48) or between 90 and up to 110 weeks (for week 96), used if multiple results available. Missing values excluded.|From study entry to Weeks 48 and 96|All subjects in the two randomized arms were assessed.||cells/mm^3||Inter-Quartile Range|Median
748675|NCT00537394|Secondary|Change in Cardiovascular Risk Score From Baseline|Cardiovascular risk score defined by Framingham providing an estimate of the probability of developing cardiovascular disease over the next 10-year period. Persons with a historical cardiovascular event (CAD, cerebro- or peripheral- vascular disorder, MI or stroke), were excluded, and scores were not calculated at follow-up times after individuals had a cardiovascular event. Missing values for input data (e.g. smoking status) resulted in a missing value for Framingham score.|At Weeks 24, 48, and 96|Persons not starting treatment (N=1; N=2), who had cardiovascular disease prior to study entry (N=12; N=8), or were missing input values needed to calculate a baseline Framingham score (N= 6; N=4), were excluded.||units on a scale||Standard Deviation|Mean
748676|NCT00537394|Secondary|Number of Participants Self-reporting Non-adherence to Assigned Study ARVS (Excluding NRTIs, if Applicable)|Results represent self-report of non-adherence during the 4-day period prior to the outcome evaluation visit. Participants in follow-up for whom these data are missing for any reason are inferred as not-adherent.|At Weeks 24 and 48|Persons not starting study treatment, or not receiving assigned study treatment by randomization were excluded from all analyses. If person no longer in study follow-up before beginning of week 24 or 48 evaluation window, additionally excluded as applicable.||participants|||Number
748677|NCT00537394|Secondary|Change in Summarized Quality of Life Score|Quality-of-life score at each evaluation based upon a single question assessing participants' self-report of general health with a range of 0 (representing worst health status) to 100 (representing perfect health).|At study entry and Weeks 24, 48, 96|Two randomized arms only.||units on a scale||Inter-Quartile Range|Median
748678|NCT00537394|Secondary|Change in Plasma HIV-1 Viral Load From Baseline to Week 1|Method of Kaplan and Meier used to accommodate left-censoring for those whose week 1 levels < 50 copies/mL.|From baseline to Week 1 evaluation|Modified intent to treat population among two randomized arms only: 2 participants (both in Omit NRTIs arm) were excluded because their baseline and week 1 RNA levels were both < 50 copies/mL.||log10 copies/mL||Inter-Quartile Range|Median
748691|NCT00537407|Primary|Change From Baseline in log10 Hepatitis C Virus RNA at Day 29 in the Debio 025 Triple Therapy Treatment Arms (A, D, and E)|Hepatitis C virus RNA was quantified in plasma samples using real time polymerase chain reaction.|Baseline to Day 29|Intent-to-treat population: All randomized participants with at least a Baseline and 1 on- or post-treatment hepatitis C virus RNA assessment.||Log10(IU/mL)||Standard Deviation|Mean
748679|NCT00537394|Secondary|Number of Participants With Plasma HIV-1 Viral Load < 50 Copies/ml|Number of participants with plasma HIV-1 Viral load < 50 copies/mL at study visit weeks 24, 48, and 96. Closest observed result between 20 and up to 30 weeks (for week 24), between 42 and up to 54 (for week 48), and between 90 and up to 110 (for week 96) used if multiple results available. Missing values excluded.|At Weeks 24, 48, 96|ITT - among 2 randomized arms only; closest value to scheduled week used if multiple values available; missing values excluded. Numbers analyzed at each time point represent those with a valid RNA result.||participants|||Number
748680|NCT00537394|Secondary|Time From Randomization to Confirmed Virological Failure|Virologic failure defined as confirmed (two consecutive) plasma HIV-1 RNA meeting 1 of the following 4 criteria: < 1.0 log10 copies/mL reduction from baseline level and >= 200 copies/mL at or after week 12 evaluation; >= 200 copies/mL after 1 measurement < 200 copies/mL; absence of any values < 200 copies/mL by and including week 24 evaluation; >= 200 copies/mL at week 48 evaluation. Event time was the scheduled study visit week when the initial plasma HIV-1 RNA specimen meeting the failure definition was collected. Censoring time was the latest scheduled study visit week when a plasma HIV-1 RNA specimen was collected and tested.|From randomization to week 96 study visit|ITT (all randomized participants) included.||weeks||95% Confidence Interval|Number
748681|NCT00537394|Secondary|Time From Randomization to Discontinuation of Randomized NRTI Component of Study Treatment|Discontinuation of Randomized NRTI component of Study Treatment is defined as permanently stopping all NRTIs among those randomized to add NRTIs, or starting any NRTI among those randomized to omit NRTIs. Subjects leaving the study for reasons other than death, relocation, incarceration, or site closure were reviewed for meeting this outcome by a blinded, independent panel. Additionally, any participant failing to start study treatment after randomization and prior to closure was also reviewed. Event times were scheduled study weeks when discontinuation events occurred. Censoring times were latest scheduled study visit weeks with evaluation.|From randomization to week 96 study visit|All randomized participants included (i.e. ITT analysis).||weeks||95% Confidence Interval|Number
748682|NCT00537394|Secondary|Time From Treatment Dispensation to First Study ARV Modification (Excluding NRTIs, if Applicable)|First study ARV modification included any discontinuation or substitution of any chosen and initiated ARV for any reason. Events prompting study medication change could include protocol required (e.g. safety), protocol recommended but not required (e.g. virologic failure), or participant motivated (such as non-adherence, loss to follow-up or death; in other words, not protocol recommended or required). Event times were the exact weeks from treatment initiation to the time of qualifying regimen modification. Censoring times were the exact weeks from treatment initiation to the last date of study drugs. The week 96 (final study visit) could occur up through 110 weeks following randomization.|From treatment dispensation to week 96 study visit|Only randomized participants included, and those who never started study treatment were excluded.||weeks||95% Confidence Interval|Number
748683|NCT00537394|Secondary|Time From Treatment Dispensation to First Grade 3 or Higher (and at Least One Grade Higher Than Baseline) Signs/Symptom or Laboratory Abnormality|Events following permanent discontinuation of NRTI assignment are excluded (i.e. censoring at time of this event, if applicable). Week 96 study visit could occur up to 110 weeks following randomization. Censoring time was the latest study visit when participant was evaluated or when NRTI assignment was discontinued (when applicable). Event time was the exact number of weeks following treatment initiation when the qualifying sign/symptom started (for those safety events triggered by a sign/symptom), or exact number of weeks following treatment initiation when specimen from qualifying laboratory result was drawn (for those safety events triggered by a laboratory abnormality).|From treatment dispensation to week 96 study visit|Only randomized participants included. Persons not starting study treatment excluded.||weeks||95% Confidence Interval|Number
748684|NCT00537394|Primary|Percent of Participants With Regimen Failure, Defined as a Confirmed Virologic Failure or Discontinuation of Randomized NRTI Component of Study Treatment|Virologic failure defined as confirmed plasma HIV-1 RNA meeting 1 of the following 4 criteria: < 1.0 log10 copies/mL reduction from baseline level and >= 200 copies/mL at or after week 12 evaluation; >= 200 copies/mL after 1 measurement < 200 copies/mL; absence of any values < 200 copies/mL by and including week 24 evaluation; >= 200 copies/mL at week 48 evaluation. Discontinuation of Randomized NRTI component of Study Treatment is defined as permanently stopping all NRTIs among those randomized to add NRTIs, or starting any NRTI among those randomized to omit NRTIs. Subjects leaving the study for reasons other than death, relocation, incarceration, or site closure were reviewed for the discontinuation outcome by a blinded, independent panel. Additionally, any participant failing to start study treatment after randomization and prior to closure was also reviewed. Results report percent of participants reaching regimen failure outcome by week 48 evaluation using Kaplan-Meier method.|From study entry to end of Week 48 evaluation window|Analysis uses intent to treat population, among the two randomized arms only.||percentage of participants||95% Confidence Interval|Number
748685|NCT00537407|Secondary|Percentage of Participants With a Sustained Viral Response 24 Weeks After the End of Treatment (Week 72 or 96)|A participant had a sustained viral response if their viral RNA was undetectable (< 10 IU/mL).|24 weeks after the end of treatment (Week 72 or 96)|Intent-to-treat population: All randomized participants with at least a Baseline and 1 on- or post-treatment hepatitis C virus RNA assessment.||percentage of participants|||Number
748686|NCT00537407|Secondary|Percentage of Participants With an End-of-treatment Response at the End of Treatment (Week 48 or 72)|A participant had an end-of-treatment response if their viral RNA was undetectable (< 10 IU/mL).|End of treatment (Week 48 or 72)|Intent-to-treat population: All randomized participants with at least a Baseline and 1 on- or post-treatment hepatitis C virus RNA assessment.||percentage of participants|||Number
748687|NCT00537407|Secondary|Percentage of Participants With an Early Viral Response at Week 12|A participant had an early viral response if their viral RNA had decreased ≥ 2 log10 at Week 12 compared to Baseline.|Baseline to Week 12|Intent-to-treat population: All randomized participants with at least a Baseline and 1 on- or post-treatment hepatitis C virus RNA assessment.||percentage of participants|||Number
748688|NCT00537407|Secondary|Percentage of Participants With a Rapid Viral Response at Day 29|A participant had a rapid viral response if their viral RNA was undetectable (< 10 IU/mL).|Day 29|Intent-to-treat population: All randomized participants with at least a Baseline and 1 on- or post-treatment hepatitis C virus RNA assessment.||percentage of participants||95% Confidence Interval|Number
756047|NCT00591344|Secondary|Distance Walked in 6 Minutes|This is how far an individual can walk in 6 minutes|obtained during initial evaluation & then every 6 six months to end of 2-yr training period||||||
748692|NCT00537485|Secondary|The Modified Hoehn and Yahr Stage|Mean change (LOCF) from baseline in the Modified Hoehn and Yahr Severity of Illness at the end of maintenance period. The Modified Hoehn and Yahr criteria are measured on the following 8-point scale for staging: 0, No signs of disease; 1, Unilateral disease; 1.5, Unilateral plus axial involvement; 2, Bilateral disease without impairment of balance; 2.5, Mild bilateral disease with recovery on pull test; 3, Mild to moderate bilateral disease, some postural instability, physically independent 4, Severe disability, still able to walk or stand unassisted; and 5, Wheelchair bound or bedridden unless aided.|Baseline, end of maintenance period|FAS, LOCF||Percentage of participants|||Number
748693|NCT00537485|Secondary|Total of Each Sum Score of UPDRS Part 1, 2, 3, and 4|"Mean change (LOCF) from baseline to the end of maintenance period in total of each sum score of UPDRS Part 1, 2, 3 and 4.
UPDRS sub-scale Part 1, 2, 3, and 4 assess 4, 13, 14, and 11 items respectively. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, every two weeks|FAS, LOCF||Scores on a scale||Standard Deviation|Mean
748694|NCT00537485|Secondary|UPDRS Part 4 Sum Score|"Mean change (LOCF) from baseline in UPDRS Part 4 sum score at every two weeks after dosing.
UPDRS sub-scale Part 4 assesses 11 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, every two weeks|FAS, LOCF||Scores on a scale||Standard Deviation|Mean
748695|NCT00537485|Secondary|UPDRS Part 1 Sum Score|"MMean change (LOCF) from baseline in UPDRS Part 1 sum score at every two weeks after dosing.
UPDRS sub-scale Part 1 assesses 4 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, every two weeks|FAS, LOCF||Scores on a scale||Standard Deviation|Mean
748696|NCT00537485|Secondary|Efficacy Rate in UPDRS Part 3 Sum Score|Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in UPDRS Part 2 sum score at every two weeks after dosing.|Baseline, every two weeks|FAS, LOCF||Percentage of participants||95% Confidence Interval|Number
748697|NCT00537485|Secondary|UPDRS Part 3 Sum Score|"Mean change (LOCF) from baseline in UPDRS Part 3 sum score at every two weeks after dosing.
UPDRS sub-scale Part 3 assesses 14 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, every two weeks|FAS, LOCF||Scores on a scale||Standard Deviation|Mean
748698|NCT00537485|Secondary|Efficacy Rate in UPDRS Part 2 Sum Score|Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in UPDRS Part 2 sum score at every two weeks after dosing.|Baseline, every two weeks|||Percentage of participants||95% Confidence Interval|Number
748699|NCT00537485|Secondary|Mean Change in UPDRS Part 2 Sum Score|"Mean change (LOCF) from baseline in UPDRS Part 2 sum score at every two weeks after dosing.
UPDRS sub-scale Part 2 assesses 13 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, every two weeks|||Scores on a scale||Standard Deviation|Mean
748700|NCT00537485|Secondary|Efficacy Rate in Total of Each Sum Score of UPDRS Part 2 and Part 3|Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in total of each sum score of UPDRS Part 2 and Part 3 at the end of maintenance period|baseline, end of maintenance period|FAS, LOCF||Percentage of participants||95% Confidence Interval|Number
748701|NCT00537485|Primary|Change From Baseline to the End of Maintenance Period in Total of Each Sum Score of UPDRS Part 2 and Part 3|"Mean change (LOCF) from baseline to the end of maintenance period in total of each sum score of UPDRS Part 2 and Part 3.
UPDRS is a scale for monitoring Parkinson's Disease-related disability and impairment. The UPDRS consists of the following four sub-scales. Part 1: Mentation, Part 2: Activities of Daily Living, Part 3: Motor, Part 4: Complications. Part 2 assesses 13 items and Part 3 assesses 14 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|baseline, end of maintenance period|Full analysis set (FAS), last observation carried forward (LOCF)||Scores on a scale||Standard Deviation|Mean
748702|NCT00537511|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Recovery Period or Maintenance (Monotherapy) Phase|Adverse event (AE) = any noxious, unintended, or untoward medical occurrence occurring at any dose that may appear or worsen in a participant during the course of a study, including new intercurrent illness, worsening concomitant illness, injury, or any concomitant impairment of participant's health, including laboratory test values, regardless of etiology. TEAE = any AE occurring or worsening on or after the first treatment with any study drug. 'Related' = suspected by investigator to be related to study treatment. National Cancer Institute [NCI] Common Toxicity Criteria for Adverse Events [CTCAE], Version 4.0, grades: 1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, 5 = death.|Cycle 7 to discontinuation (21-day cycles). Median (full range) duration of exposure (in weeks) to pomalidomide during Maintenance Phase was 5.0 (1.1, 36.0).|Safety population; participants continuing in the Recovery Period and Maintenance Phase.||participants|||Number
748703|NCT00537511|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the MTD (Combination Treatment) Phase|Adverse event (AE) = any noxious, unintended, or untoward medical occurrence occurring at any dose that may appear or worsen in a participant during the course of a study, including new intercurrent illness, worsening concomitant illness, injury, or any concomitant impairment of participant’s health, including laboratory test values, regardless of etiology. Serious adverse event (SAE) = any AE which: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. TEAE = any AE occurring or worsening on or after the first treatment with any study drug. Related = suspected by investigator to be related to study treatment. National Cancer Institute [NCI] Common Toxicity Criteria for Adverse Events [CTCAE], Version 4.0, grades: 1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, 5 = death.|Cycles 1-6 (21-day cycles). Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6).|Safety population||participants|||Number
748704|NCT00537511|Secondary|Overall Survival|Overall Survival was defined as time (in weeks) from enrollment to death. The median is based on Kaplan-Meier estimate, with 95% confidence intervals about the median overall survival. Overall survival was censored at the last time participant was known to be alive for those who were alive at time of analysis.|From enrollment through study termination (approximately 35 months)|Participants in the ITT population.||weeks||95% Confidence Interval|Median
748705|NCT00537511|Secondary|Duration of Response|Duration of Response was calculated from first Partial Response (PR) or Complete Response (CR) to disease progression. Duration of response was censored at the last date that the participant was known to be progression-free for: 1) participants who had not progressed at the time of analysis; 2) participants who had been removed from the treatment phase prior to documentation of progression.|From first Partial Response (PR) or Complete Response (CR) to disease progression (maximum of 19.4 weeks)|Number of participants in ITT population who were considered Responders.||weeks||Standard Deviation|Mean
748706|NCT00537511|Secondary|Tumor Response Rate According to Response Evaluation Criteria in Solid Tumors (RECIST)|Investigator's best assessment of response based on RECIST criteria during the MTD phase. For target lesions: Complete Response (CR)=Disappearance of all target lesions; Partial Response (PR)=≥30% decrease in sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD; Progressed Disease (PD)=≥20% increase in sum of LD of target lesions taking as reference the smallest sum LD recorded since treatment started or the appearance of ≥1 new lesions; Stable Disease (SD)=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum LD since treatment started. For non-target lesions: CR= Disappearance of all non-target lesions and normalization of tumor marker level; Incomplete Response/SD=Persistence of ≥1 non-target lesions and/or maintenance of tumor marker level above normal limits; PD=Appearance of ≥1 new lesions; unequivocal progression of existing non-target lesions.|Cycles 1 -6 (21-day cycles)|ITT population. 'Not Assessed' category includes participants who did not have adequate data for response assessment at baseline and/or post-baseline prior to the use of any non-protocol anti-tumor therapy.||participants|||Number
748707|NCT00537511|Secondary|Number of Participants With Dose Limiting Toxicities (DLTs) During the MTD Phase|For the purposes of determining the MTD (see Primary Outcome Measure), a DLT was defined as any 1 or more of the following: inability to deliver all 3 doses of cisplatin and etoposide due to toxicity; inability to deliver 14 consecutive days of daily pomalidomide dosing because the participant did not tolerate the medication due to any of the following: ≥ grade 3 non-hematological toxicity (excluding alopecia) occurring before Day 14 of pomalidomide dosing; febrile neutropenia (absolute neutrophil count [ANC] <1,000/µL and fever >101ºF, core temperature); grade 4 neutropenia of ≥7 days duration with onset on or before Day 14 of pomalidomide dosing; platelet count <25,000/µL occurring before Day 14 of pomalidomide dosing. National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE), Version 4.0, grades: 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death.|Cycles 1 - 6 (21-day cycles)|Safety Population||participants|||Number
748708|NCT00537511|Primary|Maximum Tolerated Dose (MTD)|The MTD was defined as the highest dose level at which no more than 1 in 6 participants experienced a dose-limiting toxicity (DLT) during the first 21-day cycle of treatment. The MTD Phase included the Treatment period (Cycle 1: Identification of the MTD) and the Extension period (Cycles 2 to 6: Confirmation of Safety of the MTD). (See Secondary Outcome Measure 2 for data on DLTs.)|Cycle 1 (21 days)|Safety Population||mg|||Number
748709|NCT00537680|Secondary|FACT|Friedreich’s Ataxia Composite Test|6 Months||||||
748710|NCT00537680|Secondary|ADL of FARS|ADL=Activities of Daily Living|6 Months||||||
748711|NCT00537680|Secondary|FARS|Friedreich’s Ataxia Rating Scale|6 Months||||||
748712|NCT00537680|Primary|ICARS|"International Cooperative Ataxia Rating Scale (ICARS):
ICARS consists of a one-hundred-point semi-quantitative scale based upon 19 simple testing manoeuvres compartmentalized into postural and stance disorders, limb ataxia, dysarthria and oculomotor disorders and has been previously used in this patient population with good inter-rater reliability.
Scores for each subscale quantify the extent of ataxia in each clinically important area. Subscale scores are summed to give a total score ranging from 0 (best) to 100 (worst)."|baseline and 6 months|||ICARS points||Standard Deviation|Mean
748713|NCT00537745|Primary|% Days w/1+Interlock Test Failures|This describes the percent of days in past month where the subject at least 1 interlock test failure.|One month post treatment|Twelve subjects were consented. One was dropped because of no interlock device. Another subject completed Visit 1 and then decided she did not want to receive any injections. Of the ten remaining subjects, seven received all 3, one received 2, and two received only 1, injection. These 10 subjects were used in the intent to treat analysis.||percent of days||Full Range|Mean
748714|NCT00537745|Primary|Evidence of Attempts to Drive After Drinking|"This was measured as Percent of days with an Interlock report of Failure to Start due to alcohol pre/on medication and 6 months post medication."|6 months|Twelve subjects were consented. One was dropped because of no interlock device. Another subject completed Visit 1 and then decided she did not want to receive any injections. Of the ten remaining subjects, seven received all 3, one received 2, and two received only 1, injection. These 10 subjects were used in the intent to treat analysis.||percent of days|Participants|Full Range|Mean
748715|NCT00537771|Secondary|Time to Treatment Failure||Within 3 years|||days||95% Confidence Interval|Median
748716|NCT00537771|Secondary|Incidence of Abnormal Liver Function|The second objectives are to compare ARIMIDEX (anastrozole) 1 mg once daily with Tamoxifen 20 mg once daily as adjuvant treatment in terms of: incidences of abnormal liver function test, and time to treatment failure.|At 48 weeks, 96 weeks, 144 weeks|||participants|||Number
748717|NCT00537771|Primary|Incidence of Fatty Liver Disease|The primary objective is to compare ARIMIDEX (anastrozole) 1 mg once daily with Tamoxifen 20 mg once daily as adjuvant treatment in terms of: incidence of fatty liver diseases.|At 48 weeks, 96 weeks, 144 weeks|||participants|||Number
748718|NCT00537810|Primary|BMI||4 months treatment|Participants with complete data reported here (i.e., no imputation)||BMI (kg/m^2)||Standard Deviation|Mean
748719|NCT00537810|Primary|Binge Eating (Remission)|Remission from binge eating (zero binge episodes during previous 28 days)|4 months treatment; 6 and 12 month follow up post treatment|||participants|||Number
749306|NCT00535392|Primary|Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (up to 4 Days)||Treatment period (up to 4 days)|All 33 subjects enrolled in the study were in the Intent to Treat (ITT) population and are included in this analysis.||Subjects|||Number
748720|NCT00537823|Secondary|Change in Tumor Size From Pretreatment to Preoperative CT Scan|-Compare total longest diameter from baseline to preoperative CT scan.|Completion of neoadjuvant therapy (approximately 8 weeks)|2 participants did not have the CT scan prior to surgery as both did not complete preoperative chemotherapy due to adverse skin reactions to cetuximab.||percentage of change of longest diameter||Full Range|Median
748721|NCT00537823|Secondary|Effect of Preoperative Chemotherapy on Tumor Size|Number of participants whose tumor size decreased from baseline to completion of preoperative chemotherapy.|Upon completion of neoadjuvant chemotherapy (approximately 2 months)|2 participants did not have the CT scan prior to surgery as both did not complete preoperative chemotherapy due to adverse skin reactions to cetuximab.||participants|||Number
748722|NCT00537823|Secondary|Liver Injury Scale Score (0-27)||Time of surgery (approximately 11-16 weeks)|Data was not collected for this outcome measure as the study pathologist left the institution early prior to study closure.|||||
748723|NCT00537823|Secondary|Nonalcoholic Steatohepatitis Score (0-3)|"NASH Scoring
Steatosis **<5% = 0
**5-33%=1
**>33-66%=2
**>66%=3
Lobular inflammation
**No foci=0
**<2 foci per x 200 field=1
**2-4 foci per x 200 field=2
**>4 foci per x 200 field=3
Hepatocellular ballooning **None=0 **Few balloon cells = 1 **Many cells/prominent ballooning=2"|Time of surgery (approximately 11-16 weeks)|"4 participants did not have surgery and are not included in this outcome measure.
The study pathologist left the university early prior to completion of study pathology for this study."||participants|||Number
748724|NCT00537823|Secondary|Histologic Hepatic Toxicity at Surgery||Time of surgery (approximately 11-16 weeks)|4 participants did not have surgery.||participants|||Number
748725|NCT00537823|Secondary|Postoperative Recurrence Patterns|Liver only vs distant disease|Up to 5 years|7 participants were not evaluable. 4 participants did not have surgery (3 in Arm 1, 1 in Arm 2). 1 participant had surgery but was not resectable (Arm 1) . 1 participant developed another primary cancer (Arm 1). 1 participant died before recurrence from hepatic failure (Arm 1).||participants|||Number
748726|NCT00537823|Primary|All-cause Mortality||30 days following surgery|4 participants did not have surgery.||participants|||Number
748727|NCT00537823|Primary|Major Postoperative Complication Rate|Fraction of patients with any complication grades IV and V|30 days following surgery|4 participants did not have surgery.||percentage of participants|||Number
748728|NCT00537823|Primary|Postoperative Complication Rate|Fraction of patients with any grade of complication I-V|30 days following surgery|4 participants did not have surgery.||percentage of participants|||Number
748729|NCT00537940|Secondary|Percentage of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) Score.|MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Percentage of participants with optimal sleep are reported.|Baseline, Week 21|FAS included all randomized participants who had received at least 1 blinded dose of study drug and had at least 1 baseline and post baseline primary efficacy evaluation. N (number of participants analyzed)=participants who were evaluable for this measure. n=number of participants evaluable at specifictime points for each arm group, respectively.||percentage of participants|||Number
748730|NCT00537940|Secondary|Medical Outcomes Study Sleep Scale (MOS-SS) Score.|Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity (range:0-24), optimal sleep (yes/no), and 9 item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except adequacy, optimal sleep and quantity, higher scores=more impairment. Scores transformed (actual raw score [RS] minus lowest possible score divided by possible RS range*100); total score range:0-100; higher score=more intensity of attribute.|Baseline, Week 21|FAS included all randomized participants who had received at least 1 blinded dose of study drug and had at least 1 baseline and post baseline primary efficacy evaluation. n=number of participants evaluable at specific time points for each arm group, respectively.||Units on a scale||Standard Error|Least Squares Mean
748731|NCT00537940|Secondary|Hospital Anxiety and Depression Scale (HADS) Score.|HADS: participant rated questionnaire with 2 subscales. Hospital Anxiety and Depression Scale - anxiety (HADS-A) assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); Hospital Anxiety and Depression Scale - depression (HADS-D) assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.|Baseline, Week 21|FAS included all randomized participants who had received at least 1 blinded dose of study drug and had at least 1 baseline and post baseline primary efficacy evaluation. N (number of participants analyzed)=participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||Units on a scale||Standard Error|Least Squares Mean
748732|NCT00537940|Secondary|Reduction in Proportion of the 28-day SGTC Seizure Rate Over the Total Partial Seizure Rate at Week 21.|SGTC Responder is defined as a participant who shows reduction from Baseline to double-blind phase in proportion of 28-Day SGTC Seizure Rate to 28-Day All Partial Seizure Rate.|6 weeks Baseline, 21 weeks through End of MP for 27 weeks|SGTC population included all participants who had at least 1 SGTC seizure during either Baseline or double-blind phase. n is the number of participants analyzed for SGTC. Twenty-six participants were not included in the n because they did not have a post Baseline all partial seizure, but they were included in the analysis by seizure type.||percentage of responders||95% Confidence Interval|Number
748733|NCT00537940|Secondary|Change From Baseline in the 28-day Secondarily Generalized Tonic-clonic (SGTC) Seizure Frequency at Week 21.|Change in SGTC = (Proportion of SGTC/All Partial Seizure rate during at the double-blind phase) - (Proportion of SGTC/All Partial Seizure rate at Baseline). Negative values indicate reduction from baseline.|6 weeks Baseline, 21 weeks through End of MP for 27 weeks|SGTC population included all participants who had at least 1 SGTC seizure during either Baseline or double-blind phase. n=number of participants evaluable at specific time points for each arm group, respectively.||percentage of all partial seizure/28days||Standard Deviation|Mean
750373|NCT00552240|Secondary|Change in Revised Framingham Score According to the Data Collection on Adverse Events of Anti-HIV Drugs (DAD) Study Group||baseline to week 48|Not calculated as no data on family history of cardiovascular disease were available|||||
748734|NCT00537940|Secondary|Percentage of Participants Without Seizures.|Seizure free for 28 days was defined as participants who have not experienced any seizure (simple partial, complex partial and SGTC) for at least 28 consecutive days from their last seizure until the end of the MP. Same participant could be seizure free for a specific type of seizure but not necessarily for the other types of seizure.|6 weeks Baseline, 21 weeks through End of MP for 27 weeks|FAS included all randomized participants who had received at least 1 blinded dose of study drug and had at least 1 Baseline and post Baseline primary efficacy evaluation. N (number of participants analyzed)=participants who were evaluable for this measure.||percentage of participants||95% Confidence Interval|Number
748735|NCT00537940|Secondary|Percentage of Participants With 75% Reduction From Baseline in 28-day Seizure Rate at Week 21.|Participants who had at least 75% reduction in seizure frequency from Baseline to double-blind treatment (TP + MP) were considered as 75% responders. If percent change from baseline <= -75 then 75% responder rate = 1 (yes) otherwise responder rate = 0 (no). Total partial seizure is defined as the total number of (simple partial seizure + complex partial seizure + SGTC).|6 weeks Baseline, 21 weeks through End of MP for 27 weeks|FAS included all randomized participants who had received at least 1 blinded dose of study drug and had at least 1 Baseline and post Baseline primary efficacy evaluation. n=is the number of participants that can be analyzed for each treatment group.||Percentage of participants||95% Confidence Interval|Number
748736|NCT00537940|Secondary|Percentage of Participants With 50% Reduction From Baseline in 28-day Seizure Rate at Week 21.|Participants who had at least 50% reduction in seizure frequency from Baseline to double-blind treatment (TP + MP) were considered as 50% responders. If percent change from baseline <= -50 then responder rate = 1 (yes) otherwise responder rate = 0 (no).|6 weeks Baseline, 21 weeks through End of MP for 27 weeks|FAS included all randomized participants who had received at least 1 blinded dose of study drug and had at least 1 Baseline and post Baseline primary efficacy evaluation. n=is the number of subjects that can be analyzed for each treatment group.||Percentage of participants||95% Confidence Interval|Number
748737|NCT00537940|Primary|Percent Change From Baseline in 28-day Seizure Frequency at Week 21.|The seizures were recorded by the participants, by a family member, by a caregiver, or by a legal guardian and documented in a daily seizure diary. Participant’s 28-day seizure frequency of all partial seizure was assessed during double blind (TP + MP) phase compared with baseline. Total partial seizure is defined as the total number of (simple partial seizure + complex partial seizure + secondary generalized tonic clonic seizure [SGTC]).|6 weeks Baseline, 21 weeks through End of MP for 27 weeks|Full analysis set (FAS) included all randomized participants who had received at least 1 blinded dose of study drug and had at least 1 baseline and post baseline primary efficacy evaluation.||percent change||Full Range|Median
748738|NCT00537979|Secondary|Health-related Quality of Life With Paricalcitol Injection or Oral Treatment|Analysis of the differences before and after 24 weeks of treatment in various quality of life measurements for participants on hemodialysis receiving paricalcitol injection and participants on peritoneal dialysis receiving paricalcitol capsules.|Baseline and 24 weeks|The analysis was per protocol. The per-protocol population was defined as all participants who fulfilled inclusion criteria, had intact parathyroid hormone (iPTH) values greater than or equal to 300 pg/mL at baseline, and completed the study with a final iPTH determination. The per-protocol population included 121 participants.||Participants|||Number
748739|NCT00537979|Secondary|Duration of Response to Treatment|Time in days between 2 consecutive visits with a reduction in intact parathyroid hormone (iPTH) of greater than or equal to 50% from the baseline visit.|24 weeks|The analysis was per protocol. The per-protocol population was defined as all participants who fulfilled inclusion criteria, had intact parathyroid hormone (iPTH) values greater than or equal to 300 pg/mL at baseline, and completed the study with a final iPTH determination. The per-protocol population included 121 participants.||days||Standard Deviation|Mean
748740|NCT00537979|Secondary|Time Required to Achieve: (1) a Reduction in iPTH Less Than <300 pg/mL;(2) a 50% Reduction in iPTH Compared to the Baseline Level; and (3) Either a Reduction in iPTH Less Than <300 pg/mL or a 50% Reduction in iPTH Compared to the Baseline Level|Number of days required to achieve a reduction in intact parathyroid hormone (iPTH) to less than 300 pg/mL, a reduction in iPTH of greater than or equal to 50%, or either a reduction in iPTH to less than 300 pg/mL or a reduction in iPTH of greater than or equal to 50%.|24 weeks|The analysis was per protocol. The per-protocol population was defined as all participants who fulfilled inclusion criteria, had intact parathyroid hormone (iPTH) values greater than or equal to 300 pg/mL at baseline, and completed the study with a final iPTH determination. The per-protocol population included 121 participants.||days||Standard Deviation|Mean
748741|NCT00537979|Secondary|Proportion of Subjects Who Achieve an iPTH <300 pg/mL|Number of participants who achieved an intact parathyroid hormone (iPTH) level of less than 300 pg/mL.|24 weeks|The analysis was intention to treat (ITT). The ITT population was defined as all participants who fulfilled inclusion criteria and received at least one dose of paricalcitol.||participants|||Number
748742|NCT00537979|Secondary|Analysis of Episodes of Hypercalcemia (> 11.5 mg/dL), Hyperphosphatemia (> 7.0 mg/dL) and Elevations of Calcium x Phosphorus Product (> 75)|Number of participants with hypercalcemia (calcium levels greater than 11.5 mg/dL), hyperphosphatemia (phosphorus levels greater than 7.0 mg/dL), or calcium x phosphorus product levels greater than 75.|24 Weeks|The analysis was intention to treat (ITT). The ITT population was defined as all participants who fulfilled inclusion criteria and received at least one dose of paricalcitol.||participants|||Number
748743|NCT00537979|Primary|Proportion of Subjects Who Achieve at Least a 50% Reduction in iPTH Compared to Baseline Level|Number of participants who achieved at least a 50% reduction in intact parathyroid hormone (iPTH) compared to the baseline level.|24 weeks|The analysis was intention to treat (ITT). The ITT population was defined as all participants who fulfilled inclusion criteria and received at least one dose of paricalcitol.||participants|||Number
748744|NCT00538213|Secondary|The GM Number of CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker|The vaccine strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and Pool FLU antigens and the markers assessed were CD8-All doubles, CD40L, IFN-γ, IL-2 and TNF-α.|At Days 0 and 21|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity were available at day 21.||CD8 cells/10^6 CD8+ cells||Standard Deviation|Geometric Mean
748745|NCT00538213|Secondary|The Geometric Mean (GM) Number of CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker|The vaccine strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and Pool FLU antigens and the markers assessed were Cluster of Differentiation 4-All doubles i.e. CD4-All doubles, CD40 Ligand (CD40L), interferon-gamma (IFN-γ), interleukin-2 (IL-2) and tumor necrosis factor alpha (TNF-α).|At Days 0 and 21|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity were available at day 21.||CD4 cells/10^6 CD4+ cells||Standard Deviation|Geometric Mean
748746|NCT00538213|Secondary|The Number of Subjects Seroprotected to HI Antibodies|Seroprotection was defined as serum HI titer ≥1:40 that usually is accepted as indicating protection. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Days 0 and 21|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity were available at day 21.||subjects|||Number
748747|NCT00538213|Secondary|HI Antibody Seroconversion Factors (SCF)|SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Day 21|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity were available at day 21.||fold increase||95% Confidence Interval|Geometric Mean
748748|NCT00538213|Secondary|The Number of Subjects Seroconverted to HI Antibodies|Seroconversion was defined as either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Day 21|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity were available at day 21.||subjects|||Number
748749|NCT00538213|Secondary|The Number of Subjects Seropositive to HI Antibodies|Seropositivity was defined as antibody titer greater than or equal to the cut-off value i.e. ≥ 1:10. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Days 0 and 21|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity were available at day 21.||subjects|||Number
748750|NCT00538213|Secondary|Haemagglutination Inhibition (HI) Antibody Titers|Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Days 0 and 21|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity were available at day 21.||titer||95% Confidence Interval|Geometric Mean
748751|NCT00538213|Primary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade and related was event assessed by the investigator as causally related to the study vaccination.|Day 0-20|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
748752|NCT00538213|Primary|Number of Subjects Reporting at Least One, Grade 3 and Related Medically Significant Conditions (MSCs)|MSCs were defined as AEs with a medically-attended visit i.e. prompting emergency room (ER) visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. At least one MSC was defined as at least one MSC experienced. Grade 3 was MSC that prevented normal activities and Related was defined as MSC assessed by the investigator to be causally related to the study vaccination.|Day 0-20|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
748753|NCT00538213|Primary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was event that prevented normal activities and related was defined as unsolicited AE assessed by the investigator to be causally related to the study vaccination.|Day 0-20|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
748754|NCT00538213|Primary|Duration of Solicited General AEs|Duration was defined as number of days with any grade of general symptoms.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.||Days||Full Range|Median
748755|NCT00538213|Primary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs|Any temperature was defined as axillary temperature ≥38.0 degree centigrade (°C), grade 3 temperature was axillary temperature ≥39.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relation to vaccination and grade 3 was defined as general symptom that prevented normal activity. Related was general symptom assessed by the investigator as causally related to the study vaccination.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
748756|NCT00538213|Primary|Duration of Solicited Local AEs|Duration was defined as number of days with any grade of local symptoms.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.||Days||Full Range|Median
748757|NCT00538213|Primary|Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)|Grade 3 ecchymosis, redness and swelling was greater than 100 millimeter i.e. >100 mm and grade 3 pain was considerable pain at rest that prevented normal everyday activities. Any was occurrence of any local symptom regardless of their intensity grade.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
763315|NCT00668785|Secondary|Mean Change From Pre-PRP Optical Coherence Tomography (OCT) in Central Foveal Thickness and Macular Volume as Assessed by OCT at 1, 2 and 3 Months.||March 2010||||||
748758|NCT00538291|Primary|Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by spiral CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Assessment after every 2 cycles of treatment, up to 1 year.|The three patients not completing at least two courses of treatment were considered treatment failures and were included in efficacy analysis.||number of responding participants|||Number
748759|NCT00538304|Secondary|Percentage of Patients Who Reported No Change in the Appearance of Their Eyes Since the Beginning of the Study at Month 1|Percentage of patients who reported no change in the appearance of their eyes since the beginning of the study. Patients were asked “Are you experiencing a change in how your eye looks now since you began your current glaucoma medication?”. The responses were yes or no. If yes, patient was asked for primary reason and if better, worse or as expected based on what the doctor’s office told them to expect.|Month 1|Modified Intent-to-Treat (m-ITT). The m-ITT population included all patients who were enrolled in the study, received at least 1 dose of study medication and were evaluated for macroscopic conjunctival hyperemia at baseline and the month 1 visits.||Percentage of Patients|||Number
748760|NCT00538304|Secondary|Percentage of Patients Who Were Very or Extremely Willing to Use This Glaucoma Medication at Month 1|Percentage of patients who were very or extremely willing to continue to use this glaucoma medication based on their reported response to the question. Patients were asked “Overall, based on how well this drug lowered your IOP, your concern about the preservation of your vision, balanced with any side effects you may have experienced using your medication, would you be willing to continue this medication (eye drops) if your physician prescribed it?”. The responses were extremely willing, very willing, somewhat willing and not willing. If not willing, patient was asked for reason.|Month 1|Modified Intent-to-Treat (m-ITT). The m-ITT population included all patients who were enrolled in the study, received at least 1 dose of study medication and were evaluated for macroscopic conjunctival hyperemia at baseline and the month 1 visits.||Percentage of Patients|||Number
748761|NCT00538304|Secondary|Percentage of Physicians Who Were Very or Extremely Willing to Continue Patient on Drug, if Drug Were Marketed at Month 1|Percentage of physicians who were very or extremely willing to continue patient on drug if drug were marketed based on their reported response to the question. Physicians were asked “Overall, based on how well this drug lowered THIS patient’s IOP, balanced with any adverse events she/he may have experienced, would you consider continuing THIS medication (if the drug was marketed)?”. The responses were extremely willing, very willing, somewhat willing and not willing. If not willing, physician was asked for reason.|Month 1|Modified Intent-to-Treat (m-ITT). The m-ITT population included all patients who were enrolled in the study, received at least 1 dose of study medication and were evaluated for macroscopic conjunctival hyperemia at baseline and the month 1 visits.||Percentage of Physicians|||Number
748762|NCT00538304|Secondary|Change From Baseline in Mean Intraocular Pressure (IOP) at Month 1|Change from baseline in mean (average) IOP at Month 1 8 AM timepoint. IOP is a measurement of the fluid pressure inside the eye. For each eye, the IOP was either the average of the 2 measurements, or, if a third measurement was required, the median of the 3 measurements. A negative number change from Baseline indicated a reduction in IOP.|Baseline, Month 1|Modified Intent-to-Treat (m-ITT). The m-ITT population included all patients who were enrolled in the study, received at least 1 dose of study medication and were evaluated for macroscopic conjunctival hyperemia at baseline and the month 1 visits.||millimeters of mercury (mmHg)||Standard Deviation|Mean
748763|NCT00538304|Secondary|Percentage of Patients With an Increase in Macroscopic Conjunctival Hyperemia in Either Eye at Month 1|Percentage of patients with a >= 1 unit increase in macroscopic conjunctival hyperemia in either eye at the Month 1, 8 AM time point. Macroscopic conjunctival hyperemia is graded by the investigator who compares the patient’s visual appearance of eye redness to standard photographs using a 5-point scale (Scale 0 to +3: none, trace, mild, moderate, severe).|Month 1|Modified Intent-to-Treat (m-ITT). The m-ITT population included all patients who were enrolled in the study, received at least 1 dose of study medication and were evaluated for macroscopic conjunctival hyperemia at baseline and the month 1 visits.||Percentage of Patients|||Number
748764|NCT00538304|Primary|Change From Baseline in Mean Peak Macroscopic Conjunctival Hyperemia at Month 1|Change from Baseline in macroscopic conjunctival hyperemia (or visible eye redness). Macroscopic conjunctival hyperemia is graded by the investigator who compares the patient’s visual appearance of eye redness to standard photographs using a 5-point scale (Scale 0 to +3: none, trace, mild, moderate, severe). The peak change is calculated for each eye by subtracting the largest score across the hourly measurements at baseline from the largest score across the hourly measurements at month 1. A positive number severity grade change from baseline indicated an increase in redness.|Baseline, Month 1|Modified Intent-to-Treat (m-ITT). The m-ITT population included all patients who were enrolled in the study, received at least 1 dose of study medication and were evaluated for macroscopic conjunctival hyperemia at baseline and the month 1 visits.||Number on a scale (score)||Standard Deviation|Mean
748765|NCT00538434|Secondary|Mean Percent Change From Baseline to End of Treatment in the Child Health Questionnaire (CHQ)|CHQ is a quality-of-life (QoL), observer-rated (the parent in this study) instrument designed to assess the general health and well-being of pediatric subjects aged 5 to 18 years. The instrument comprises 50 items that cover 14 unique physical and psychological concepts. Each item was scored separately following different scales and timeframes for response. Proprietary scoring algorithms are used. This outcome reports the two CHQ Summary Scores (Physical Summary Score and the Psychosocial Summary Scores) which are indexed to a 0 (poorest quality of life) to 100 (best quality of life) scores. The two summary scores are subsequently combined (via proprietary algorithm) to create the Global Health Summary Score (also on a 0-100 scale). Percent change from baseline values range from 100% (poorest QoL at baseline, best QoL at end of treatment) to -100% (best QoL at baseline, poorest QoL at end of treatment). Higher percent change from baseline values indicate improved QoL.|Baseline, End of Treatment (up to 15 weeks +/- 4 days)|ITT population: all randomized participants who received any amount of study drug with both a baseline and an End of Treatment assessment; n=number of participants with a response in the given category.||percentage change in score||Standard Deviation|Mean
748832|NCT00538629|Primary|Clinical Global Impression of Severity (CGI-S) Scores (Bipolar Population)|CGI-S assesses the severity of the condition at baseline using a scale that ranges from (1)Normal, not ill at all to (7) Among the most severely ill patients.|Baseline|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.||Participants|||Number
748766|NCT00538434|Secondary|Mean Change From Baseline to End of Treatment in EE Predominant Symptom Assessment|Participants rated the severity of each EE symptom (vomiting/regurgitation, abdominal/chest pain, and dysphagia) based on the previous week’s daily diary as none (=0), mild, moderate, severe, or very severe (=4). The predominant symptom was selected at the baseline visit and remained the same throughout the trial. The predominant symptom was defined as the EE symptom that had the greatest negative impact on the participant. The full range for change from baseline values is -4 (very severe at baseline, none at end of study) to 4 (none at baseline, severe at end of study). Negative change from baseline scores in the Patient's EE Predominant Symptom Assessment indicate improvement in the selected symptom.|Baseline (Day 1, pre-treatment), End of Treatment (Week 15, 3 weeks [± 4 days] after the last dose of study drug, or at early withdrawal)|ITT population: all randomized participants who received any amount of study drug with both a baseline and an End of Treatment assessment.||units on a scale||Standard Deviation|Mean
748767|NCT00538434|Primary|Mean Change From Baseline in Physician's Esophageal Eosinophil (EE) Global Assessment At The End-of-Treatment Visit (or at Early Withdrawal)|"The investigator completed the Physician’s EE Global Assessment based upon the participant’s reporting of symptoms, weight, dietary status, and overall well-being. The assessment rated severity on a five-point scale (0=none to 4=very severe), taking into account physical findings, vital signs, the Subject’s Predominant EE Symptom Assessment, the subject’s diary data, and dietary questions. The Subject's Predominant EE Symptom was the EE symptom (vomiting/regurgitation, abdominal/chest pain, or dysphagia) that had the greatest negative impact on the subject based on patient diary data as of the baseline visit.
The full range for change from baseline values is -4 (very severe at baseline, none at end of study) to 4 (none at baseline, severe at end of study). Negative change from baseline scores in the Physician's EE Global Assessment indicate improvement in EE status."|Baseline (Day 1, pre-treatment), End of Treatment (Week 15, 3 weeks [± 4 days] after the last dose of study drug, or at early withdrawal)|ITT population: all randomized participants who received any amount of study drug with both a baseline and an End of Treatment assessment.||units on a scale||Standard Deviation|Mean
748768|NCT00538434|Primary|Mean Percent Change From Baseline to End of Treatment in Peak Esophageal Eosinophil (EE) Levels|Participants underwent esophagogastroduodenoscopy (EGD) with biopsy (2 biopsies each at proximal and distal esophageal locations, plus any inflamed or abnormal areas) per standard clinical practice for the determination of esophageal eosinophils.|Baseline, End of Treatment (up to 15 weeks [+/- 4 days])|ITT population: all randomized participants who received any amount of study drug.||percentage change in eosinophils/hpf||Standard Deviation|Mean
748769|NCT00538473|Secondary|Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains|Results are presented as geometric mean number of specific influenza CD8 T lymphocytes per million T lymphocytes. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia. Results are given for All doubles (i.e. CD8 T lymphocytes expressing at least 2 different cytokines [Cluster of Differentiation 40L (CD40L), Interleukin-2 (IL-2), Tumor Necrosis Factor alpha (TNF-α), Interferon gamma (IFN-γ)]) and for CD8 T lymphocytes expressing one particular cytokine (CD40L, IL-2, TNF-α, or IFN-γ) and least one other.|At Days 0 and 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Cells per million||Standard Deviation|Geometric Mean
748770|NCT00538473|Secondary|Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains|Results are presented as geometric mean number of specific influenza CD4 T lymphocytes per million T lymphocytes. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia. Results are given for All doubles (i.e. CD4 T lymphocytes expressing at least 2 different cytokines [Cluster of Differentiation 40L (CD40L), Interleukin-2 (IL-2), Tumor Necrosis Factor alpha (TNF-α), Interferon gamma (IFN-γ)]) and for CD4 T lymphocytes expressing one particular cytokine (CD40L, IL-2, TNF-α, or IFN-γ) and least one other.|At Days 0 and 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Cells per million||Standard Deviation|Geometric Mean
748771|NCT00538473|Secondary|Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains|A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.|At Days 0 and 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
748772|NCT00538473|Secondary|Seroconversion Factors (SCFs) for HI Antibodies Against Each of the Three Vaccine Strains|Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.|At Day 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||fold increase||95% Confidence Interval|Mean
748773|NCT00538473|Secondary|Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains|A seroconverted subject was defined as a subject who had either a pre-vaccination titer below1:10 and a post-vaccination titer greater than or equal to1:40 or a pre-vaccination titer greater than or equal to1:10 and at least a four-fold increase in post-vaccination titer. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.|At Day 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
748774|NCT00538473|Secondary|Number of Subjects Seropositive for HI Antibodies Against Each of the Three Vaccine Strains|A seropositive subject was defined as a subject with a serum HI titer greater than or equal to 1:10. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.|At Days 0 and 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
748775|NCT00538473|Secondary|Serum Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Strains|Titers were expressed as Geometric Mean Titers. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.|At Days 0 and 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Titer||95% Confidence Interval|Geometric Mean
748776|NCT00538473|Primary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any: occurrence of any SAE regardless of their relationship to vaccination. Related: SAE assessed by the investigator as causally related to the study vaccination.|Throughout the entire study (up to Day 21)|The analysis was performed on the Total Vaccinated Cohort including all subjects with the study vaccine administered.||Subjects|||Number
748777|NCT00538473|Primary|Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs)|Medically Significant Conditions (MSCs) included all unsolicited adverse events that resulted in a medically attended visit. Any: occurrence of any MSC regardless of their intensity grade or relationship to vaccination. Grade 3: MSC that prevented normal everyday activities. Related: MSC assessed by the investigator as causally related to the study vaccination.|During a 21-day follow-up period after vaccination|The analysis was performed on the Total Vaccinated Cohort including all subjects with the study vaccine administered.||Subjects|||Number
748778|NCT00538473|Primary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any: occurrence of any unsolicited AE regardless of their intensity grade or relationship to vaccination. Grade 3: unsolicited AE that prevented normal everyday activities. Related: unsolicited AE assessed by the investigator as causally related to the study vaccination.|During a 21-day follow-up period after vaccination|The analysis was performed on the Total Vaccinated Cohort including all subjects with the study vaccine administered.||Subjects|||Number
748779|NCT00538473|Primary|Duration of Solicited General Symptoms|Duration was expressed as median number of days any symptom persisted. Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any: occurrence of any general symptom regardless of their intensity grade or relationship to vaccination.|During a 7-day follow-up period after vaccination|The analysis was performed on the Total Vaccinated Cohort on those subjects who reported the specific symptom.||Days||Full Range|Median
748780|NCT00538473|Primary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any: any symptom regardless of intensity grade; any fever: oral temperature greater than or equal to 38 degrees Celsius (°C). Grade 3: symptoms that prevented normal activity ; Grade 3 fever: oral temperature greater than 39°C. Related: symptom assessed by the investigator as causally related to the study vaccination.|During a 7-day follow-up period after vaccination|The analysis was performed on the Total Vaccinated Cohort including all subjects with the study vaccine administered.||Subjects|||Number
748781|NCT00538473|Primary|Duration of Solicited Local Symptoms|Duration was expressed as median number of days any symptom persisted. Solicited local symptoms assessed include ecchymosis, pain, redness and swelling. Any: occurrence of any local symptom regardless of their intensity grade.|During a 7-day follow-up period after vaccination|The analysis was performed on the Total Vaccinated Cohort on those subjects who reported the specific symptom.||Days||Full Range|Median
748782|NCT00538473|Primary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed include ecchymosis, pain, redness and swelling. Any: any symptom regardless of intensity grade. Grade 3 pain: considerable pain at rest, which prevented normal everyday activities. Grade 3 ecchymosis, redness and swelling: more than 100 millimeter.|During a 7-day follow-up period after vaccination|The analysis was performed on the Total Vaccinated Cohort including all subjects with the study vaccine administered.||Subjects|||Number
748783|NCT00538512|Secondary|Measure Immune Response Induced by the Vaccines and Identify Serologic Correlates of Immune Protection||one influenza season - 2007-08||||||
748784|NCT00538512|Primary|Laboratory-confirmed (Culture and/or PCR) Symptomatic Influenza||one influenza season - 2007-2008|ITT||participants|||Number
748785|NCT00538590|Primary|Postoperative Intraocular Pressure Change|Postoperative intraocular pressure change at 30 days compared to baseline (preoperative) intraocular pressure measured in mmHg. Calculated as postoperative intraocular pressure minus baseline (preoperative) intraocular pressure.|30 days|||mm Hg||Standard Deviation|Mean
748786|NCT00538590|Primary|Postoperative Intraocular Pressure Change|Postoperative intraocular pressure change at 90 days compared to baseline (preoperative) intraocular pressure measured in mmHg. Calculated as postoperative intraocular pressure minus baseline (preoperative) intraocular pressure.|90 days|||mm Hg||Standard Deviation|Mean
748787|NCT00538590|Primary|Postoperative Intraocular Pressure Change|Postoperative intraocular pressure change at 180 days compared to baseline (preoperative) intraocular pressure measured in mmHg. Calculated as postoperative intraocular pressure minus baseline (preoperative) intraocular pressure.|180 days|||mm Hg||Standard Deviation|Mean
748788|NCT00538590|Secondary|Complications|Incidence (percentage) for complications recorded: Hyphema, early hypotony(<7days), late hypotony(>7days), shallow anterior chamber, choroidal detachment, early leak(<7days), late leak(>7days), Tenon's cysts, and revision surgery for up to 360 days.|360 days|||percentage of participants||Standard Deviation|Mean
748789|NCT00538590|Primary|Postoperative Intraocular Pressure Change|Postoperative intraocular pressure change at 360 days compared to baseline (preoperative) intraocular pressure measured in mmHg. Calculated as postoperative intraocular pressure minus baseline (preoperative) intraocular pressure.|360 days|||mm Hg||Standard Deviation|Mean
748790|NCT00538616|Primary|Lactate/Pyruvate (L/P)Ratio|L/P ratio was measured before during and after sedation assessment. The micromole value for each dialysate (lactate and pyruvate) was reported as well as the ratio (L/P). Elevated ratios (greater than 30) were attributed to metabolic distress (relative hypoxemia)during the course of the trial.|1 hour|||ratio||Standard Deviation|Mean
748791|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Mental Health?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline and final visit (week 12)|The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication.||Participants|||Number
748792|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Health?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline to final visit (week 12)|The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication.||Participants|||Number
748793|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Relationship With Your Family?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline and final visit (week 12)|The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication.||Participants|||Number
748794|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Sex Life?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline and final visit (week 12)|The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia and who had received at least 1 dose of study medication.||Participants|||Number
748795|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With the People You Live With?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.|Baseline and final visit (week 12)|The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication.||Participants|||Number
748796|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Personal Safety?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline and final visit (week 12)|The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication.||Participants|||Number
748797|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: In the Past Year, Have You Been a Victim of Physical Violence?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.|Baseline and final visit (week 12)|The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication.||Participants|||Number
748798|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: In the Past Year, Have You Been Accused of a Crime?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.|Baseline and final visit|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.||Participants|||Number
748799|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Accomodation?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline and final visit (week 12)|The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication.||Participants|||Number
748800|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Leisure Activities?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline and final visit (week 12)|The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication.||Participants|||Number
748801|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With the Number and Quality of Your Friendships?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline and final visit (week 12)|The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication.||Participants|||Number
748802|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: In the Last Week Have You Seen a Friend?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.||Participants|||Number
748803|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: Do You Have Anyone You Would Call a Close Friend?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.||Participants|||Number
748804|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores(Schizophrenia Population) in Answer to: How Satisfied Are You With Your Financial Situation?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.||Participants|||Number
748805|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Job?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.|Baseline and final visit (week 12)|The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication.||Participants|||Number
748806|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Life as a Whole Today?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline and final visit (week 12)|The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication.||Participants|||Number
748807|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Mental Health?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.||Participants|||Number
748808|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Health?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.||Participants|||Number
748809|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Relationship With Your Family?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.||Participants|||Number
748810|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Sex Life?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.||Participants|||Number
748811|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With the People You Live With?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication||Participants|||Number
748812|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Personal Safety?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.||Participants|||Number
748813|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: In the Past Year, Have You Been a Victim of Physical Violence?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.||Participants|||Number
748814|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: In the Past Year Have You Been Accused of a Crime?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.||Participants|||Number
748815|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Leisure Activities?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.||Participants|||Number
748816|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Accomodation?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.||Participants|||Number
748817|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With the Number and Quality of Your Friendships?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication||Participants|||Number
748818|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: In the Last Week Have You Seen a Friend?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects who had been diagnosed with bipolar mania and had received at least 1 dose of study medication.||Participants|||Number
748819|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: Do You Have Anyone You Would Call a Close Friend?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects who had been diagnosed with bipolar mania and had received at least 1 dose of study medication.||Participants|||Number
748820|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Financial Situation?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects who had been diagnosed with bipolar mania and had received at least 1 dose of study medication.||Participants|||Number
748821|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Job?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.||Participants|||Number
748822|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Life as a Whole Today?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.||Participants|||Number
748823|NCT00538629|Primary|Global Efficacy Evaluation Scores (Schizophrenia Population)|The Global Efficacy Evaluation assesses the final efficacy of ziprasidone on schizophrenia symptoms using a 5-point scale that ranges from very good to worsening of the original disease.|Final visit (week 12)|The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication.||Participants|||Number
748824|NCT00538629|Primary|Global Efficacy Evaluation Scores (Bipolar Population)|The Global Efficacy Evaluation assesses the final efficacy of ziprasidone on bipolar symptoms using a 5-point scale that ranges from very good to worsening of the original disease.|Final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.||Participants|||Number
748825|NCT00538629|Primary|Extrapyramidal Symptom (EPS) Scores (Schizophrenia Population: Baseline and Final Visit|EPS assesses 4 items: akathisia, dystonia, dyskinesia, and parkinsonism. Each item is scored on a 5-point severity scale ranging from 1 to 5, with higher score indicating greater severity of symptom. Change: score at final visit minus score at baseline.|Baseline and final visit (week 12)|The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication. If any individual item was missing, the total score was set to missing.||Score on scale||Standard Deviation|Mean
748826|NCT00538629|Primary|Brief Psychiatric Rating Scale (BPRS) Scores (Schizophrenia Population): Change From Baseline|BPRS is an 18-item scale with 11 general symptom items, 5 positive-symptom items, and 2 negative symptom items. The physician completes the BPRS, and each item is scored on a 7-point scale, with higher score indicating greater severity of symptom. Change: score at final visit minus score at baseline.|Baseline to final visit (week 12)|The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication. If any individual item was missing, the total score was set to missing.||Score on scale||Standard Deviation|Mean
748827|NCT00538629|Primary|Clinical Global Impressions Change (CGI-C) Scores (Schizoprenia Population)|CGI-C assesses change in severity of the condition using a scale that ranges from (1) very much improved to (7) very much worse. Higher score indicates increasing severity of disease.|Final visit (week 12)|The schizophrenia full analysis set included all subjects who had been diagnosed with schizophrenia and had received at least 1 dose of study medication.||Participants|||Number
748828|NCT00538629|Primary|Clinical Global Impressions Change (CGI-C) Scores (Bipolar Population)|CGI-C assesses change in severity of the condition using a scale that ranges from (1) very much improved to (7) very much worse. Higher score indicates increasing severity of disease.|Final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.||Participants|||Number
748829|NCT00538629|Primary|Montgomery Asberg Depression Rating Scale (MADRS) Scores (Bipolar Population): Change From Baseline|MADRS measures treatment effect on depression severity. MADRS assesses apparent and reported sadness, inner tension, sleep, appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Higher score indicates greater severity of disease. Change: score at final visit minus score at baseline.|Baseline to final visit (12 weeks)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication. If any individual item was missing, the total score was set to missing.||Score on scale||Standard Deviation|Mean
748830|NCT00538629|Primary|Young Mania Rating Scale (YMRS) Scores (Bipolar Population): Change From Baseline|The YMRS is an 11-item questionnaire that rates the severity of bipolar disorder, with higher score indicating greater severity of disease. Change: score at final visit minus score at baseline.|Baseline to final visit (12 weeks)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication. If the final visit measurement was missing, the follow-up measurement could be carried forward. If any individual item was missing, the total score was set to missing.||Score on scale||Standard Deviation|Mean
748831|NCT00538629|Primary|Clinical Global Impression of Severity (CGI-S) Scores (Schizophrenia Population)|CGI-S assesses the severity of the condition at baseline using a scale that ranges from (1)Normal, not ill at all to (7) Among the most severely ill patients.|Baseline|The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication||Participants|||Number
748833|NCT00538642|Primary|Insulin Sensitivity|Euglycemic clamp method|4-5 months|||mg glucose/kg.min/μIU insulin||Standard Deviation|Mean
748834|NCT00538642|Secondary|LDL Cholesterol||4-5 months|||mg/dL||Standard Deviation|Mean
748851|NCT00531817|Secondary|Mean Change From Baseline in C-reactive Protein (CRP) at Days 3 and 7|Serum concentration of CRP (high-sensitivity CRP [hsCRP] test) was analyzed by a central laboratory.|Baseline to Days 3 and 7|C-reactive protein (CRP) population: A subset of patients enrolled at designated study sites who met the CRP entry criteria (CRP ≥ 1 mg/dL), received at least 1 dose of study medication, and attended the Day 3 or Day 7 visit. No imputation of missing data was made; only observed data are reported.||mg/dL||Standard Deviation|Mean
748852|NCT00531817|Secondary|Percentage of Patients With an Improvement of at Least 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20, ACR50, ACR70) From Baseline at Day 7|Improvement must be seen in tender and swollen joint counts and in at least 3 of the following 5 parameters. Patient and physician assessment of patient disease activity (DA) in previous 24 hours on a visual analog scale (VAS, no DA to maximum DA); patient assessment of pain in previous 24 hours on a VAS (none to unbearable); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and C reactive protein or, if missing, erythrocyte sedimentation rate.|Baseline to Day 7|C-reactive protein (CRP) population: A subset of patients enrolled at designated study sites who met the CRP entry criteria (CRP ≥ 1 mg/dL), received at least 1 dose of study medication, and attended the Day 3 or Day 7 visit. LOCF was used for missing joint count data. Patients with missing data or who escaped were classified as non-responders.||Percentage of participants|||Number
748853|NCT00531817|Secondary|Mean Change From Baseline in Individual Components of the Routine Assessment Patient Index Data (RAPID) at Each Day During the First 7 Days of Treatment|Derived from the Multidimensional Health Assessment Questionnaire (MDHAQ), the RAPID includes 3 domains that assess disease activity in rheumatoid arthritis: A physical function score (0-10), a pain visual analog scale score (VAS, 0-100), and a global assessment of disease activity VAS score (0-100). Each domain was assessed with the Patient Take Home Form (PTHF). Higher scores indicate more disease activity. A negative change score indicates improvement.|Baseline through Day 7|Intent-to-treat population: All randomized patients who received at least 1 dose of study medication. No imputation of missing data was made; only observed data are reported.||Units on a scale||Standard Deviation|Mean
748854|NCT00531817|Secondary|Mean Change From Baseline in the Medical Outcomes Study (MOS) Sleep Scale Score at Weeks 4, 8, 12, 16, 20, and 24|The MOS Sleep Scale is a 12-item patient self-report instrument that assesses the quality and quantity of sleep over the previous 4 weeks. A sleep problems index (SLP9) was generated using 9 of the 12 items (1, 3, 4, 5, 6, 7, 8, 9, 12). Each item was normalized so that the lowest and highest possible scores were set to 0 and 100, respectively. The SLP9 score is the average of the recoded 9 items. The SLP9 score ranged from 0 to 100. Higher scores represent greater sleep problems. A negative change score indicates improvement.|Baseline to Weeks 4, 8, 12, 16, 20, and 24|Intent-to-treat population: All randomized patients who received at least 1 dose of study medication. No imputation of missing data was made; only observed data are reported.||Units on a scale||Standard Deviation|Mean
748855|NCT00531817|Secondary|Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Weeks 4, 8, 12, 16, 20, and 24|The FACIT-F is a 13-item patient self-report questionnaire that assesses fatigue over the previous 7 days by scoring each item on a 5-point scale (0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit, 4=Very much). An overall FACIT-F score was obtained by summing the scores of all 13 items. The overall score ranged from 0 to 52. A lower score indicates less fatigue. A negative change score indicates improvement.|Baseline to Weeks 4, 8, 12, 16, 20, and 24|Intent-to-treat population: All randomized patients who received at least 1 dose of study medication. No imputation of missing data was made; only observed data are reported.||Units on a scale||Standard Deviation|Mean
748856|NCT00531817|Secondary|Mean Change From Baseline in 12-Item Short Form Health Survey v2 (SF-12) Scores at Weeks 4, 8, 12, 16, 20, and 24|The SF-12 is a self-report measure of general health status with 1 or 2 items for each of 8 domains: Physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health. Two component summaries, physical (PCS-12) and mental (MCS-12) were calculated using norm-based scoring, resulting in means of 50 and standard deviations of 10 in the 1998 general United States population. Higher scores represent better health and a positive change from baseline represents improvement.|Baseline to Weeks 4, 8, 12, 16, 20, and 24|Intent-to-treat population: All randomized patients who received at least 1 dose of study medication. No imputation of missing data was made; only observed data are reported.||Units on a scale||Standard Deviation|Mean
748857|NCT00531817|Secondary|Mean Change From Baseline in the Routine Assessment Patient Index Data (RAPID) Score at Weeks 4, 8, 12, 16, 20, and 24|Derived from the Multidimensional Health Assessment Questionnaire (MDHAQ), the RAPID includes 3 domains that assess disease activity in rheumatoid arthritis: A physical function score (MDHAQ items 1a-j), a pain visual analog scale score (VAS, item 2 in the MDHAQ), and a global assessment of disease activity VAS score (item 6 in the MDHAQ). Each domain is scored on a scale of 0-10. The RAPID score is the sum of the 3 domain scores divided by 3 resulting in a total score on a scale of 0-10. Higher scores indicate more disease activity and a negative change from baseline indicates improvement.|Baseline to Weeks 4, 8, 12, 16, 20, and 24|Intent-to-treat population: All randomized patients who received at least 1 dose of study medication. No imputation of missing data was made; only observed data are reported.||Units on a scale||Standard Deviation|Mean
748858|NCT00531817|Secondary|Percentage of Patients With European League Against Rheumatism (EULAR) Good, Moderate, or no Response at Weeks 4, 8, 12, 16, 20, and 24|Change of the DAS28 score from baseline was used to determine the EULAR responses of good, moderate, or no response. For a post-baseline score ≤ 3.2, a change from baseline of < -1.2 was a good response, < -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-baseline score > 3.2 to ≤ 5.1, a change from baseline of < -0.6 was a moderate response and ≥ -0.6 was no response. For a post-baseline score > 5.1, a change from baseline < -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-baseline scores > 3.2.|Baseline to Weeks 4, 8, 12, 16, 20, and 24|Intent-to-treat population: All randomized patients who received at least 1 dose of study medication. Missing data was imputed as “no response”.||Percentage of participants|||Number
749026|NCT00540293|Secondary|Percent Change From Baseline in High Sensitive Circulating C-reactive Protein (Hs-CRP) After 4 and 8 Weeks of Treatment|Percent change from baseline in hs-CRP by risk group - FAS|4 and 8 weeks|Laboratory Population: 10 subjects from FAS (n=425) were not included in Laboratory Population (n=415).||percentage||95% Confidence Interval|Median
748859|NCT00531817|Secondary|Mean Change From Baseline in Disease Activity Score 28 (DAS28) at Weeks 4, 8, 12, 16, 20, and 24|DAS28 was calculated using the following formula: 0.56 × sqrt(TJC) + 0.28 × sqrt(SJC) + 0.70 × ln(ESR) + 0.014 × GH, where TJC = tender joint count on 28 joints, SJC = swollen joint count on 28 joints, ESR = erythrocyte sedimentation rate at the current visit (mm/hr), and GH = general health, ie, the patient’s global assessment of disease activity (DA) in the previous 24 hours on a 100 mm visual analog scale (no DA to maximum DA). The DAS28 score ranges from 0 to 10, with higher scores indicating more rheumatoid arthritis. A negative change score indicates improvement.|Baseline to Weeks 4, 8, 12, 16, 20, 24|Intent-to-treat population: All randomized patients who received at least 1 dose of study medication. No imputation of missing data was made; only observed data are reported.||Units on a scale||Standard Deviation|Mean
748860|NCT00531817|Primary|Percentage of Patients With an Improvement of at Least 50% in American College of Rheumatology (ACR) Score (ACR50) From Baseline at Week 24|Improvement must be seen in tender and swollen joint counts and in at least 3 of the following 5 parameters. Patient and physician assessment of patient disease activity (DA) in previous 24 hours on a visual analog scale (VAS, no DA to maximum DA); patient assessment of pain in previous 24 hours on a VAS (none to unbearable); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and C-reactive protein or, if missing, erythrocyte sedimentation rate.|Baseline to Week 24|Intent-to-treat population: All randomized patients who received at least 1 dose of study medication. In determining ACR status, a last observation carried forward (LOCF) approach was used for missing joint count data. Patients with missing data or who escaped were classified as non-responders.||Percentage of participants|||Number
748861|NCT00531817|Secondary|Percentage of Patients With an Improvement of at Least 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20, ACR50, ACR70) From Baseline at Weeks 4, 8, 12, 16, 20, and 24|Improvement must be seen in tender and swollen joint counts and in at least 3 of the following 5 parameters. Patient and physician assessment of patient disease activity (DA) in previous 24 hours on a visual analog scale (VAS, no DA to maximum DA); patient assessment of pain in previous 24 hours on a VAS (none to unbearable); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and C reactive protein or, if missing, erythrocyte sedimentation rate.|Baseline to Weeks 4, 8, 12, 16, 20, 24|Intent-to-treat population: All randomized patients who received at least 1 dose of study medication. In determining ACR status, a last observation carried forward (LOCF) approach was used for missing joint count data. Patients with missing data or who escaped were classified as non-responders.||Percentage of participants|||Number
748862|NCT00531843|Secondary|Increased Bleeding Attributed to Fondaparinux|Coagulopathic bleeding due to fondaparinux was suspected in patients requiring packed red cell transfusions after initiation of fondaparinux therapy only if the change in hematocrit prompting transfusion was not clinically commensurate with the degree of injuries that the patient had sustained (primarily orthopaedic) and/or the hematocrit did not respond appropriately post-transfusion.|3 weeks post injury|||participants|||Number
748863|NCT00531843|Primary|Presence of Deep Vein Thrombosis (DVT) or Pulmonary Embolus (PE)|Color-flow duplex venous ultrasonography examinations of upper and lower extremities were performed within 48 hours of injury, and then weekly until discharge or 3 weeks. DVT was defined as any clot occurring in the subclavian, iliac, femoral, or popliteal location. Patients were examined daily for clinical signs and symptoms of venous thromboembolism (VTE) and PE. Small, nonocclusive clots discovered in other locations were observed for progression on sequential ultrasonography examinations.|within 3 weeks post injury|Of 11 patients with initial contraindication to anticoagulation, 5 were cleared by the treating physicians to receive fondaparinux within 3 days of injury, and 6 were not.||participants|||Number
748864|NCT00531843|Secondary|Normal Trough and Peak Fondaparinux Concentration|Serum samples were collected 30 minutes before (trough) and 2 hours after (peak) the third dose of fondaparinux. Normative data plots comparing study participants with healthy volunteers were supplied by the company outsourced to analyze samples.|Day 3|Serum samples were obtained from 63 representative patients from our study who received Fondaparinux and compared against normative values from normal volunteers supplied by our sponsor.||Participants|||Number
748865|NCT00531882|Primary|Neutrophil Delivery to the Oral Mucosa Using a Non-invasive Mouthwash Technique|Oral mucosal polymorphonuclear leukocytes (PMN) are obtained and assessed using a modification of the mouthwash method of (Wright et.al. Blood 1986;67:1023-30). For each subject, PMN counts are assessed on days 1, 2, 3 [Baseline (B)]; days 8, 9, 10 [Treatment (T)]; and days 11, 13, 15 [Recovery (R)]. The PMN counts for each subject are averaged for each study time period (B, T or R) within each study arm (Pioglitazone, Simvastatin and Ibuprofen). The mean baseline (B) PMN counts are compared to the mean treatment (T) PMN counts for each study arm, with the results expressed as the percent change in PMN counts . Paired T-tests between baseline and treatment PMN counts are used to analyze for significance. The recovery period is used to verify that the PMN counts return to baseline following the treatment period. Data from the recovery period is not shown.|3X Before treatment (Days 1,2,3) 3X During treatment (Days 8,9,10)|Healthy volunteers free of gingival disease were randomized 2:2:1 to oral Pioglitazone, Simvastatin or Ibuprofen respectively for 10 days.||% change in mean PMN counts: B vs T|||Number
748866|NCT00531934|Secondary|Quality of Life Score as Assessed by Visual Analog Scale (VAS)|Quality of life was assessed by participant's responses to a VAS questionnaire - (evaluation of satisfaction with skin status). VAS was measured on a 100 millimeter (mm) scale where 0 = not at all satisfied and 100 = very satisfied. Participants were asked to mark the line corresponding to their satisfaction at each visit and the distance from the left edge was measured. A negative change from baseline indicates improvement. Analysis was performed by visit well as at the last available value after baseline (Endpoint).|Baseline, Days 14 and 28, and Months 2, 3, and 4|ITT population; n=number of participants assessed for the specified parameter at a given visit.||mm||Standard Deviation|Mean
748882|NCT00531934|Secondary|Duration of Skin Rash (Folliculitis) During the Whole Treatment Period|If the end of cutaneous rash was missing, the duration of cutaneous rash was calculated between start of folliculitis and last evaluation date.|Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12|ITT Population; only participants with an event (folliculitis) were included in the analysis.||days||Standard Deviation|Median
750401|NCT00552240|Secondary|Number of Participants With HIV Viral Load < 50 Copies/ml at Week 12 of Treatment|Results within time windows, patients on-treatment|baseline to week 12|All treated patients||Participants|||Number
748867|NCT00531934|Secondary|Percentage of Participants by DLQI Global Score Classification of Disease Effect on Quality of Life|Quality of life was assessed by participant's responses to a DLQI questionnaire. The DLQI is a 10-item questionnaire assessing quality of life; questions were assessed on a 4-point scale (0=not at all; 1=a little; 2=a lot; and 3=very much). The DLQI was calculated by summing the score of each question resulting in a maximum of 30 (extremely large effect on participant's life) and a minimum of 0 (no effect at all on participant's life). The higher the score, the more quality of life is impaired. The DLQI global score was classified into 5 levels: 0-1 (no effect at all), 2-5 (small effect), 6-10 (moderate effect), 11-20 (very large effect) and 21-30 (extremely large effect).|Baseline, Days 14 and 28 and Months 2, 3, and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
748868|NCT00531934|Secondary|Dermatology Life Quality Index (DLQI) Global Score|Quality of life was assessed by participant's responses to a DLQI questionnaire. The DLQI is a 10-item questionnaire assessing quality of life; questions were assessed on a 4-point scale (0=not at all; 1=a little; 2=a lot; and 3=very much). The DLQI was calculated by summing the score of each question resulting in a maximum of 30 (extremely large effect on participant's life) and a minimum of 0 (no effect at all on participant's life). The higher the score, the more quality of life is impaired. Analysis was performed by visit well as at the last available value after baseline (Endpoint); change from baseline to endpoint was also determined.|Baseline, Days 14 and 28 and Months 2, 3, and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||units on a scale||Standard Deviation|Mean
748869|NCT00531934|Secondary|Percentage of Participants Estimated to be Alive at 4 and 12 Months||Months 4 and 12|ITT Population||percentage of participants|||Number
748870|NCT00531934|Secondary|Overall Survival (OS) - Time to Event|OS was defined by the time between first intake of treatment with erlotinib and death for any cause; analyzed using Kaplan-Meier method.|Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12|ITT Population||days||95% Confidence Interval|Median
748871|NCT00531934|Secondary|Overall Survival (OS) - Percentage of Participants With an Event|OS was defined by the time between first intake of treatment with erlotinib and death for any cause; analyzed using Kaplan-Meier method.|Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12|ITT Population||percentage of participants|||Number
748872|NCT00531934|Secondary|Percentage of Participants Estimated to be Progression Free at 4 and 12 Months||Months 4 and 12|ITT Population||percentage of participants|||Number
748873|NCT00531934|Secondary|Progression-Free Survival (PFS) - Time to Event|PFS was defined by the time between first intake of treatment with erlotinib and disease progression or death for any cause; estimated using Kaplan-Meier method.|Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12|ITT Population||days||95% Confidence Interval|Median
748874|NCT00531934|Secondary|Progression-Free Survival (PFS) - Percentage of Participants With an Event|PFS was defined by the time between first intake of treatment with erlotinib and disease progression or death for any cause; estimated using Kaplan-Meier method.|Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12|ITT Population||percentage of participants|||Number
748875|NCT00531934|Secondary|Percentage of Participants by Best Global Response Under Treatment|Response was determined according to the RECIST criteria for evaluation and was defined as participants with either CR, PR, SD, or progression. No CR was reported.|Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12|ITT Population||percentage of participants|||Number
748876|NCT00531934|Secondary|Percentage of Participants With Global Disease Control by Visit|Disease control was determined according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria for evaluation and was defined as participants with either complete response (CR), partial response (PR), or stable disease (SD).|Months 2, 4, 7, 10, and 12|ITT population; number (n) = number of participants analyzed for the specified parameter at a given visit.||percentage of participants|||Number
748877|NCT00531934|Secondary|Percentage of Participants With Doxycycline Dose Reduction by Reason for Reduction|Occurrence of folliculitis-type skin rash of Grade greater than or equal to (≥)2 led to dose modification. Continuation of treatment with doxycycline after occurrence of folliculitis-type skin rash of Grade ≥2 was upon the investigator’s opinion.|Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12|ITT population; only participants that discontinued or interrupted doxycycline were included in the analysis.||percentage of participants|||Number
748878|NCT00531934|Secondary|Percentage of Participants With Erlotinib Dose Reduction by Reason for Reduction|Erlotinib dose adjustment was done in case of toxicity occurrence. Keratitis, diarrhea, interstitial lung disease, and other toxic occurrences determined erlotinib dose reduction. If erlotinib was previously discontinued for skin rash or diarrhea of Grade 2 and if these symptoms of Grade 2 recurred OR if the symptoms were intolerable for the participants, erlotinib was discontinued until recovery/Grade 1 then the dose was reduced of one level of 50 mg.|Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12|ITT population; only participants that discontinued or interrupted erlotinib were included in the analysis.||percentage of participants|||Number
748879|NCT00531934|Secondary|Percentage of Participants With Other Skin Lesions During the First 4 Months of Treatment By Maximal Intensity|Other skin lesions included xerosis and paronychia. Intensity was classified according to CTCAE grading. Grade 1=Macular or papular eruption or erythema without associated symptoms; Grade 2=Macular or papular eruption or erythema with pruritus or other associated symptoms; localized desquamation or other lesions covering <50% of BSA; Grade 3=Severe, generalized erythroderma or macular, papular, or vesicular eruption; desquamation; Grade 4=Generalized exfoliative, ulcerative, or bullous dermatitis. If a participant had several skin lesions, the maximal intensity was taken into account.|Days 0, 14, 28 and Months 2, 3, and 4|ITT population; only participants with an adverse event classified as other skin lesion during the first 4 months were included in the analysis.||percentage of participants|||Number
748880|NCT00531934|Secondary|Percentage of Participants With Other Skin Lesions During the First 4 Months of Treatment By Type|Other skin lesions included xerosis and paronychia.|Days 0, 14, 28 and Months 2, 3, and 4|ITT population||percentage of participants|||Number
748881|NCT00531934|Secondary|Percentage of Participants With Other Skin Lesions of Any Grade During the First 4 Months of Treatment|Other skin lesions included presence or absence of xerosis and paronychia.|Days 0, 14, 28 and Months 2, 3, and 4|ITT population||percentage of participants|||Number
748924|NCT00538733|Secondary|Event Free Survival||from baseline to the time of first event that lead to removal from study (defined as progression, death, withdrawal of consent, or removal for toxicity)|||months||95% Confidence Interval|Median
748883|NCT00531934|Secondary|Duration of Skin Rash (Folliculitis) During the First 4 Months of Treatment|If the cutaneous rash was ongoing at the last visit or Month 4, the duration of cutaneous rash was calculated between start of folliculitis and Visit Month 4 or premature withdrawal visit or death.|Days 0, 14, 28 and Months 2, 3, and 4|ITT Population; only participants with an event (folliculitis) were included in the analysis.||days||Standard Deviation|Mean
748884|NCT00531934|Secondary|Percentage of Participants Estimated to be Event Free at 12 Months|Percentage of participants estimated to be without skin rash (folliculitis) at 12 months.|Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12|ITT population||percentage of participants|||Number
748885|NCT00531934|Secondary|Time Free From Skin Rash (Folliculitis) During the Whole Treatment Period - Time to Event|Period without occurrence was determined as the number of days from the first dose of medication until the first appearance of folliculitis, analyzed using Kaplan-Meier analysis.|Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12|ITT population||days||95% Confidence Interval|Median
748886|NCT00531934|Secondary|Time Free From Skin Rash (Folliculitis) During the Whole Treatment Period - Number of Participants With an Event|Period without occurrence was determined as the number of days from the first dose of medication until the first appearance of folliculitis, analyzed using Kaplan-Meier analysis.|Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12|ITT population||participants|||Number
748887|NCT00531934|Secondary|Percentage of Participants Estimated to be Event Free at 4 Months|Percentage of participants estimated to be without skin rash (folliculitis) at 4 months.|Days 0, 14, 28 and Months 2, 3, and 4|ITT population||percentage of participants|||Number
748888|NCT00531934|Secondary|Time Free From Skin Rash (Folliculitis) During the First 4 Months of Treatment - Time to Event|Period without occurrence was determined as the number of days from the first dose of medication until the first appearance of folliculitis, analyzed using Kaplan-Meier analysis.|Days 0, 14, 28 and Months 2, 3, and 4|ITT population||days||95% Confidence Interval|Median
748889|NCT00531934|Secondary|Time Free From Skin Rash (Folliculitis) During the First 4 Months of Treatment - Number of Participants With an Event|Period without occurrence was determined as the number of days from the first dose of medication until the first appearance of folliculitis, analyzed using Kaplan-Meier analysis.|Days 0, 14, 28 and Months 2, 3, and 4|ITT population||participants|||Number
748890|NCT00531934|Secondary|Number of Participants With Skin Rash (Folliculitis) After the First 4 Months of Treatment By Intensity|Intensity of skin rashes was classified according to CTCAE grading. Grade 1=Macular or papular eruption or erythema without associated symptoms; Grade 2=Macular or papular eruption or erythema with pruritus or other associated symptoms; localized desquamation or other lesions covering <50% of BSA; Grade 3=Severe, generalized erythroderma or macular, papular, or vesicular eruption; desquamation.|Months 7, 10, and 12|ITT population||participants|||Number
748891|NCT00531934|Secondary|Number of Participants With Skin Rash (Folliculitis) After the First 4 Months of Treatment By Type|A cutaneous rash as folliculitis can be defined with several types including erythema, papulo-pustule, nodule, and crust.|Months 7, 10, and 12|ITT population||participants|||Number
748892|NCT00531934|Secondary|Number of Skin Rash (Folliculitis) Events After the First 4 Months of Treatment|A cutaneous rash as folliculitis can be defined with several types including erythema, papulo-pustular and nodules.|Months 7, 10, and 12|ITT population||rash events|||Number
748893|NCT00531934|Secondary|Percentage of Participants With at Least One Skin Rash (Folliculitis) of Any Grade After the First 4 Months of Treatment||Months 7, 10, and 12|ITT population||percentage of participants|||Number
748894|NCT00531934|Secondary|Percentage of Participants With Skin Rash (Folliculitis) During the First 4 Months of Treatment By Maximal Intensity|Intensity of skin rashes was classified according to CTCAE grading. Grade 1 equals (=) Macular or papular eruption or erythema without associated symptoms; Grade 2=Macular or papular eruption or erythema with pruritus or other associated symptoms; localized desquamation or other lesions covering less than (<)50 percent (%) of body surface area (BSA); Grade 3=Severe, generalized erythroderma or macular, papular, or vesicular eruption; desquamation.|Days 0, 14, 28 and Months 2, 3, and 4|ITT population; only participants with an adverse event of skin rash (folliculitis) during the first 4 months were included in the analysis.||percentage of participants|||Number
748895|NCT00531934|Secondary|Percentage of Participants With Skin Rash (Folliculitis) During the First 4 Months of Treatment By Type|A cutaneous rash as folliculitis can be defined with several types including erythema, papulo-pustule, nodule, and crust.|Days 0, 14, 28 and Months 2, 3, and 4|ITT population||percentage of participants|||Number
748896|NCT00531934|Secondary|Number of Skin Rash (Folliculitis) Events During the First 4 Months of Treatment|A cutaneous rash as folliculitis can be defined with several types including erythema, papulo-pustular and nodules.|Days 0, 14, 28 and Months 2, 3, and 4|ITT population||rash events|||Number
748897|NCT00531934|Primary|Percentage of Participants With at Least One Skin Rash (Folliculitis) of Any Grade During the First 4 Months of Treatment|Description of skin rash (folliculitis, including erythema, papulo-pustules, nodule, and crust) was according to Common Terminology Criteria for Adverse Events (CTCAE) version 3 scale. Medical pictures of the face (front and sides views) systematically, and of any region presenting with skin lesions were obtained. The pictures were reviewed by a centralized committee of evaluation.|Days 0, 14, 28 and Months 2, 3, and 4|ITT population; data for 1 participant in the erlotinib treatment group were missing.||percentage of participants|||Number
748898|NCT00531947|Secondary|Hematology - Red Blood Cell (Change From Baseline)|A summary of a secondary safety outcome measure, Hematology - Red Blood Cell (RBC)(Change from Baseline), by treatment assigned, is shown for the safety population.|12 Weeks|||x10^12/L||Standard Deviation|Mean
748899|NCT00531947|Secondary|Hematology - Hemoglobin (Change From Baseline)|A summary of a secondary safety outcome measure, Hematology - Hemoglobin(HGB)(Change from Baseline), by treatment assigned, is shown for the safety population.|12 Weeks|||g/dL||Standard Deviation|Mean
748900|NCT00531947|Secondary|Hematology - Hematocrit (Change From Baseline)|A summary of a secondary safety outcome measure, Hematology - Hematocrit(HCT)(Change from Baseline), by treatment assigned, is shown for the safety population.|12 Weeks|||percent||Standard Deviation|Mean
748901|NCT00531947|Secondary|Hematology - White Blood Cell (WBC) (Change From Baseline)|A summary of a secondary safety outcome measure, Hematology (Change from Baseline), by treatment assigned, is shown for the safety population. Mean change from Baseline in ABS BASOPHILS (X10^9/L), ABS EOSINOPHILS (X10^9/L), ABS LYMPHOCYTES (X10^9/L), ABS MONOCYTES (X10^9/L), and ABS NEUTROPHILS (X10^9/L) are presented.|12 Weeks|||(X10^9/L)||Standard Deviation|Mean
748902|NCT00531947|Secondary|12 Lead ECG (Change From Baseline)Ventricular Heart Rate|A summary of a secondary safety outcome measure, 12 Lead electrocardiogram (ECG) (Change from Baseline)Ventricular Heart Rate measured in beats per minute(beats/min or BPM), by treatment assigned, is shown for the safety population. Mean change from baseline is presented.|12 Weeks|||BPM||Standard Deviation|Mean
748903|NCT00531947|Secondary|12 Lead ECG (Change From Baseline)|A summary of a secondary safety outcome measure, 12 Lead electrocardiogram (ECG) (Change from Baseline) measured in milliseconds (msec), by treatment assigned, is shown for the safety population. Mean change from Baseline in PR interval, QRS duration, QT interval, and QTc (Bazett and Fridericia corrections) interval are presented.|12 Weeks|||msec||Standard Deviation|Mean
748904|NCT00531947|Secondary|Vital Signs-Blood Pressure (Change From Baseline)|Summary mean change in blood pressure (systolic/diastolic) measured in millimeters of mercury (mmHg) (supine, standing, and orthostatic change)results for all subjects are presented.|12 Weeks|||mmHg||Standard Deviation|Mean
748905|NCT00531947|Secondary|Vital Signs-Heart Rate (Change From Baseline)|Summary mean change in heart rate measured in beats per minute (beats/min or BPM) (supine, standing, and orthostatic change)results for all subjects are presented.|12 Weeks|||BPM||Standard Deviation|Mean
748906|NCT00531947|Secondary|Urinalysis (Change From Baseline)|A summary of a secondary safety outcome measure, Urinalysis (Change from Baseline), by treatment assigned, is shown for the safety population. Mean changes from baseline are provided for PH and specific gravity.|12 Weeks|||units on a scale||Standard Deviation|Mean
748907|NCT00531947|Secondary|Physical Examination (Screening vs. EOS)|Number of physical examination findings that were normal at screening, but abnormal at end of study are presented. Four subjects receiving placebo and four subjects receiving EMSAM had abnormal findings on physical examination at the end of study that were normal at screening.|12 Weeks|||Number of Abnormal Exams|||Number
748908|NCT00531947|Primary|CDRS-R Total Score (Child) (mITT w/LOCF Population) Week 12|"A summary of the primary efficacy outcome measure, Children's Depression Rating Scale (CDRS-R) Total Score, as reported by the Child, at Week 12 (EOS), by treatment assigned, is shown for the modified intent-to-treat (mITT) population, with the last observation carried forward (LOCF) in time.
CDRS-R total raw scores range from 17(minimum) 113(maximum). A lower score indicates a lower likelihood of a depressive disorder, a higher score indicates a higher likelihood of a depressive disorder. Two subscales are summed to calculate a total score: Evaluated Symptom Area and Ratings of Observed Nonverbal Behavior."|baseline and 12 Weeks|Received at least one dose of placebo or EMSAM study drug, and had at least one post-treatment efficacy assessment with the primary outcome variable (CDRS-R).||units on a scale||Standard Deviation|Mean
748909|NCT00531947|Secondary|CDRS-R Total Score (Best Description) Week 12 (mITT w/OC Population)|"A summary of a secondary efficacy outcome measure, Children's Depression Rating Scale (CDRS-R) Total Score (Best Description), at Week 12 (EOS), by treatment assigned, is shown for the modified intent-to-treat (mITT) population, with observed cases (w/OC).
Best Description ratings are used when ratings based on interviews with different sources (e.g., child, parent, other ratings) differ for a particular symptom area. The evaluator must determine which of these ratings most accurately represents the current affective functioning of the child, and circle that rating in the Best Description of Child Column.
CDRS-R (Best Description) total raw scores range from 17(minimum) 113(maximum). A lower score indicates a lower likelihood of a depressive disorder, a higher score indicates a higher likelihood of a depressive disorder. Two subscales are summed to calculate a total score: Evaluated Symptom Area and Ratings of Observed Nonverbal Behavior."|12 Weeks|||units on a scale||Standard Deviation|Mean
748910|NCT00531947|Secondary|CDRS-R Total Score (Parent/Other) Week 12 (mITT w/OC Population)|"A summary of a secondary efficacy outcome measure, Children's Depression Rating Scale (CDRS-R) Total Score (Scored by Parent/Other), at Week 12 (EOS), by treatment assigned, is shown for the modified intent-to-treat (mITT) population with observed cases (w/OC).
CDRS-R (Parent/Other) total raw scores range from 14 (minimum) 94 (maximum). A lower score indicates a lower likelihood of a depressive disorder, a higher score indicates a higher likelihood of a depressive disorder. One subscale is summed to calculate a total score: Evaluated Symptom Area. Ratings of Observed Nonverbal Behavior subscale is not included in Parent/Other total calculation."|12 Weeks|||units on a scale||Standard Deviation|Mean
748911|NCT00531947|Secondary|CDRS-R Total Score (Child) Week 12 (mITT w/OC Population)|"A summary of the secondary efficacy outcome measure, Children's Depression Rating Scale (CDRS-R) Total Score (Scored by Child), at Week 12 (EOS), by treatment assigned, is shown for the modified intent-to-treat (mITT) population with observed cases (w/OC).
CDRS-R (Child) total raw scores range from 17(minimum) 113(maximum). A lower score indicates a lower likelihood of a depressive disorder, a higher score indicates a higher likelihood of a depressive disorder. Two subscales are summed to calculate a total score: Evaluated Symptom Area and Ratings of Observed Nonverbal Behavior."|12 Weeks|||units on a scale||Standard Deviation|Mean
748912|NCT00531947|Secondary|CDRS-R Total Score (Best Description) Week 12 (mITT w/LOCF Population)|"A summary of a secondary efficacy outcome measure, Children's Depression Rating Scale (CDRS-R) Total Score (Best Description), at Week 12 (EOS), by treatment assigned, is shown for the modified intent-to-treat (mITT) population, with the last observation carried forward (LOCF) in time.
Best Description ratings are used when ratings based on interviews with different sources (e.g., child, parent, other ratings) differ for a particular symptom. The evaluator must determine which of these ratings most accurately represents the current affective functioning of the child, and circle that rating in the Best Description of Child Column.
CDRS-R (Best Description)total raw scores range from 17(minimum) 113(maximum). A lower score indicates a lower likelihood of a depressive disorder, a higher score indicates a higher likelihood of a depressive disorder. Two subscales are summed to calculate a total score: Evaluated Symptom Area and Ratings of Observed Nonverbal Behavior."|12 Weeks|||units on a scale||Standard Deviation|Mean
748913|NCT00531947|Secondary|CDRS-R Total Score (Parent/Other) Week 12 (mITT w/LOCF Population)|"A summary of a secondary efficacy outcome measure, Children's Depression Rating Scale (CDRS-R) Total Score (Scored by Parent/Other), at Week 12 (EOS), by treatment assigned, is shown for the modified intent-to-treat (mITT) population, with the last observation carried forward (LOCF) in time.
CDRS-R (Parent/Other) total raw scores range from 14 (minimum) 94 (maximum). A lower score indicates a lower likelihood of a depressive disorder, a higher score indicates a higher likelihood of a depressive disorder. One subscale is summed to calculate a total score: Evaluated Symptom Area. Ratings of Observed Nonverbal Behavior subscale is not included in Parent/Other total calculation."|Baseline and 12 Weeks|||units on a scale||Standard Deviation|Mean
748914|NCT00531947|Secondary|CGI-C Percent Responders (mITT w/LOCF Population)|A summary of the CGI-C percent responders at Week 12 (EOS), by treatment assigned, is shown for the mITT population with LOCF. CGI-C responders were defined as a score of 1 or 2 at the end of the study. A non-responder was defined as a score of ≥3 at end of study. Maximum score is 100%.|12 Weeks|||Percent Responder|||Number
748915|NCT00531947|Secondary|CGI-C - Week 12 (mITT w/LOCF Population)|"A summary of the Clinicians Global Impression of Change (CGI-C) Score at Week 12 (EOS), by treatment assigned, is shown for the mITT population with LOCF. The CGI-c assesses the overall change in the severity of illness (depression). The clinician rates the subject's change based on a bipolar scale from 1(minimum; Very much improved) to 7(maximum; Very much worse). A lower score indicates lower levels of depression as compared to baseline, a higher score indicates higher levels of depression as compared to baseline. A score of 4 (Unchanged) indicates no change in illness compared to baseline. The scale is not calculated as a statistical change score; the clinician rates their impression of change overall."|12 Weeks|||units on a scale||Standard Deviation|Mean
748916|NCT00531947|Secondary|CGI-S - Week 12 (mITT w/LOCF Population)|A summary of the Clinical Global Impression of Severity (CGI-S) at baseline and Week 12 (EOS), by treatment assigned, is shown for the mITT population with LOCF. The CGI-s is the clinician's assessment of severity of illness (depression). Scores range from 1(minimum) to 7(maximum). A lower score indicates lower illness severity, a higher score indicates higher levels of illness severity.|Baseline and 12 Weeks|Received at least one dose of placebo or EMSAM study drug, and had at least one post-treatment efficacy assessment with the primary outcome variable (CDRS-R).||units on a scale||Standard Deviation|Mean
748917|NCT00531960|Secondary|Percentage of Participants With Disease Control According to RECIST V 1.0|Disease control was defined as a BOR of CR, PR, or SD according to RECIST V 1.0 for at least 4 weeks at any time during randomized treatment or disease stabilization, after study entry. Participants without a post-BL assessment of response were considered as having no disease control. The 95% CI for the one sample binomial was calculated using the Pearson-Clopper method.|Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis, 12 months after the last participant’s 1st visit|FAS||percentage of participants||95% Confidence Interval|Number
748918|NCT00531960|Secondary|Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST V 1.0|BOR was defined as the best response recorded from randomization until disease progression/recurrence or death, taking as reference for PD the smallest measurement (nadir) recorded since treatment started. Assignment of PR of CR required confirmation of tumor measurement changes by repeat assessments performed no less than 4 weeks after criteria for response was first met. For TLs, CR was defined as the disappearance of all TLs; and PR was defined as at least a 30% decrease in the SLD of the TLs, taking BL SLD as reference. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. The 95% CI for one sample binomial was calculated using the Pearson-Clopper method.|Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.|FAS||percentage of participants||95% Confidence Interval|Number
748919|NCT00531960|Secondary|OS|The median time, in months, from randomization to OS event. Participants were censored at final analysis at the date the participant was last known to be alive.|Screening, Days 1, 8, and 21 of Cycles 1-8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.|FAS; only participants who died were included in this analysis.||months||95% Confidence Interval|Median
748920|NCT00531960|Secondary|Percentage of Participants Who Died|Overall survival (OS) was defined as the time from randomization to the date of death, due to any cause. Participants were censored at final analysis at the date the participant was last known to be alive.|Screening, Days 1, 8, and 21 of Cycles 1-8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.|FAS||percentage of participants|||Number
748921|NCT00531960|Primary|PFS|The median time, in weeks, from randomization to PFS event. Participants were censored at the date of last post-BL tumor assessment where non-progression was documented. If no post-BL tumor assessment was available, the participant was censored at date of randomization. PFS was estimated using Kaplan-Meier methodology.|Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.|FAS; only participants with an event (disease progression or death) were included in the analysis.||weeks||95% Confidence Interval|Median
748922|NCT00531960|Primary|Percentage of Participants With Disease Progression or Death|Progression-free survival (PFS) was defined as the time from randomization to disease progression or death, from any cause. Progressive disease (PD) was defined according to Response Criteria in Solid Tumors (RECIST) version (V) 1.0. For target lesions (TLs), progressive disease (PD) was defined as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded since the start of treatment. For non-target lesions (NTLs), PD was defined as unequivocal progression of existing NTLs. Participants were censored at the date of last post-baseline (BL) tumor assessment where non-progression was documented. If no post-BL tumor assessment was available, the participant was censored at date of randomization.|Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.|FAS||percentage of participants|||Number
748923|NCT00538733|Secondary|Progression Free Survival|"Progression determined using International Myeloma Working Group criteria, as defined below.
An increase of > 25% from lowest response value one or more of the following:
Serum M-component and/or (the absolute increase must be > 0.5 g/dL)*
Urine M-component and/or (the absolute increase must be > 200 mg/24 h)
Only in patients without measurable serum and urine M-protein levels; the difference between involved and uninvolved FLC levels. The absolute increase must be > 10 mg/dL
Bone marrow plasma cell percentage; the absolute percentage must be > 10%
Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas
Development of hypercalcaemia (corrected serum calcium > 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder *if starting serum M protein is greater then 5 g/dL, absolute increase of 1g/dL is sufficient to determine relapse."|From start of treatment, to the date of first progression|25 of the 26 patients enrolled were accessible for response/progression, as one patient expired prior to first response assessment and could not be included in the analysis.||months||95% Confidence Interval|Median
748925|NCT00538733|Secondary|Median Time to Maximum Response|Median Time to maximum response, reported in cycles of treatment. One cycle = 28 days.|from baseline to cycle with maximum response|25 of the 26 patients enrolled were accessible for response/progression, as one patient expired prior to first response assessment and could not be included in the analysis.||cycles||Full Range|Median
748926|NCT00538733|Primary|Effect of Drug Combination on Multiple Myeloma|Objective response rate, defined according to the International Myeloma Working Group (IMWG) criteria as greater then or equal to a Partial Response (PR). The best response was recorded. The IMWG criteria can be found here: imwg.myeloma.org/international-myeloma-working-group-imwg-uniform-response-criteria-for-multiple-myeloma/|This was collected from patients for their duration on study treatment. Only the best response was recorded. Best responses were reported at any point of the study, from start of treatment up until removal of study, which occurred up to 57.4 cycles|25 of the 26 patients enrolled were accessible for response/progression, as one patient expired prior to first response assessment and could not be included in the analysis.||participants|||Number
748927|NCT00538785|Secondary|Mean Trough Serum Concentrations of Motavizumab in Subjects Who Underwent Cardiac Surgery With Cardiopulmonary Bypass|Subjects who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to have a blood sample taken for determination of study drug concentrations prior to receipt of another dose of study drug immediately following surgery.|Days 0-150|Evaluable for PK following cardiac surgery with cardiopulomonary bypass; all motivizumab treated subjects who underwent cardiac surgery with cardiopulmonary bypass and who received the correct dose regiment.||ug/mL||Standard Deviation|Mean
748928|NCT00538785|Secondary|Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 4|Trough serum concentrations (ug/mL) of motavizumab at 30 days post-dose 4|30 days post-dose 4|Evaluable for PK population; all motavizumab-treated subjects who received any study drug and did not received commercial palivizumab. Excludes subjects after cardiopulmonary bypass surgery.||ug/mL||Standard Deviation|Mean
748929|NCT00538785|Secondary|Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 3|Trough serum concentrations (ug/mL) of motavizumab at 30 days post-dose 3|30 days post-dose 3|Evaluable for PK population; all motavizumab-treated subjects who received any study drug and did not received commercial palivizumab. Excludes subjects after cardiopulmonary bypass surgery.||ug/mL||Standard Deviation|Mean
748930|NCT00538785|Secondary|Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 2|Trough serum concentrations (ug/mL) of motavizumab at 30 days post-dose 2|30 days post-dose 2|Evaluable for PK population; all motavizumab-treated subjects who received any study drug and did not received commercial palivizumab. Excludes subjects after cardiopulmonary bypass surgery.||ug/mL||Standard Deviation|Mean
748931|NCT00538785|Secondary|Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 1|Trough serum concentrations (ug/mL) of motavizumab at 30 days post-dose 1|30 days post-dose 1|Evaluable for PK population; all motavizumab-treated subjects who received any study drug and did not received commercial palivizumab. Excludes subjects after cardiopulmonary bypass surgery.||ug/mL||Standard Deviation|Mean
748932|NCT00538785|Secondary|Mean Trough Serum Concentration of Motavizumab at Pre-dose 1|Trough serum concentrations (ug/mL) of motavizumab at pre-dose 1|Pre-dose 1|Evaluable for PK population; all motavizumab-treated subjects who received any study drug and did not received commercial palivizumab. Excludes subjects after cardiopulmonary bypass surgery.||ug/mL||Standard Deviation|Mean
748933|NCT00538785|Secondary|Number of Subjects Who Had Anti-motavizumab Antibodies Detected|ECLA-based method|Days 0-150|Evaluable for ADA Population; includes all motavizumab-treated subjects who received the correct study drug for their first dose and did not receive commercial palivizumab before receiving any study drug.||participants|||Number
748934|NCT00538785|Secondary|The Number of Subjects With RSV Outpatient MA-LRI for Season 2 Only.|An RSV outpatient MA-LRI was defined as an outpatient medically-attended event designated by the principal investigator as a lower respiratory illness with a positive real-time RT-PCR RSV diagnostic test performed at a central laboratory.|Days 0-150|All subjects who were randomized in Season 2||participant|||Number
748935|NCT00538785|Secondary|The Number of Subjects Hospitalized for RSV Infection.|An RSV hospitalization was defined as one of the following: 1) Cardiac/respiratory hospitalization with a positive real-time RT-PCR RSV diagnostic test performed at a central laboratory, or 2) New onset of lower respiratory tract symptoms with an objective measure of worsening respiratory status in an already hospitalized subject with a positive real-time RT-PCR RSV diagnostic test performed at a central laboratory (nosocomial RSV hospitalization), or 3) Death demonstrated to be caused by RSV (based on virologic evidence and either clinical history or autopsy).|Days 0-150|The ITT population is the primary efficacy analysis population and consists of all subjects randomized into the study.||participants|||Number
748936|NCT00538785|Primary|Number of Subjects Reporting Laboratory Adverse Events||Days 0-150|Safety population||participants|||Number
748937|NCT00538785|Primary|Number of Subjects Reporting Serious Adverse Events Through Study Day 150|Serious adverse events were those that resulted in death; were life-threatening; resulted in subject hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgment, may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above.|Days 0-150|The Safety population included all subjects who received any study drug and had any safety follow-up.||participants|||Number
748938|NCT00538785|Primary|Number of Subjects Reporting Adverse Events Through Study Day 150|Adverse events were summarized by system organ class (SOC) and preferred term (using MedDRA Version 11.1) overall.|Days 0-150|The Safety population included all subjects who received any study drug and had any safety follow-up.||participants|||Number
748939|NCT00538824|Primary|Effect of Drug Combination on Multiple Myeloma|The maximum response for all patients that were treated on study. Maximum response was assessed using the International myeloma working group (IMWG) guidelines for response. http://imwg.myeloma.org/international-myeloma-working-group-imwg-uniform-response-criteria-for-multiple-myeloma/|The best response for all patients at any point were assessed for patients that were treated on study, from start of treatment up to 20 weeks|||participants|||Number
750402|NCT00552240|Secondary|Number of Participants With HIV Viral Load < 50 Copies/ml at Week 8 of Treatment|Results within time windows, patients on-treatment|baseline to week 8|All treated patients||Participants|||Number
748940|NCT00538850|Secondary|Global Evaluation of the Study Medication at 30 and 60 Minutes After Dosing|Global evaluation of the study medication was assessed by the participant on a 5-point scale (1=Poor, 2=Fair, 3=Good, 4=Very good, 5=Excellent) at 30 and 60 minutes after each dose of study medication during each breakthrough pain episode. A higher score indicates a better evaluation.|30 through 60 minutes after dosing for each pain episode|Intent-to-treat (ITT) population: All participants in the double-blind treatment period who received at least 1 dose of study medication and had at least 1 pain measurement. 4 of the 96 participants in the ITT population were excluded from analysis because they did not have at least 1 dose of study medication and 1 dose of placebo.||Units on a scale||Standard Deviation|Mean
748941|NCT00538850|Secondary|Total Pain Relief (TOTPAR) at 5, 10, 15, 30, 45, and 60 Minutes After Dosing|Pain relief (PAR) was assessed by the participant on a 5-point scale (1=No relief, 2=A little relief, 3=Moderate relief, 4=A lot of relief, 5=Complete relief) at 5, 10, 15, 30, 45 and 60 minutes after each dose of study medication during each breakthrough pain episode. TOTPAR was calculated as the time-weighted sum of the PAR scores at each time point using the following formulas: TOTPAR5=(5*PAR5), TOTPAR10=(5*PAR5)+(5*PAR10), TOTPAR15=(5*PAR5)+(5*PAR10)+(5*PAR15), TOTPAR30=(5*PAR5)+(5*PAR10)+(5*PAR15)+(15*PAR30), TOTPAR45=(5*PAR5)+(5*PAR10)+(5*PAR15)+(15*PAR30)+(15*PAR45), TOTPAR60=(5*PAR5)+(5*PAR10)+(5*PAR15)+(15*PAR30) +(15*PAR45) +(15*PAR60). The minimum and maximum TOTPAR5, TOTPAR10, TOTPAR15, TOTPAR30, TOTPAR45, and TOTPAR60 scores were 5 to 25, 10 to 50, 15 to 75, 30 to 150, 45 to 225, and 60 to 300, respectively. A higher score indicates more pain relief.|5 through 60 minutes after dosing for each pain episode|Intent-to-treat (ITT) population: All participants in the double-blind treatment period who received at least 1 dose of study medication and had at least 1 pain measurement. 4 of the 96 participants in the ITT population were excluded from analysis because they did not have at least 1 dose of study medication and 1 dose of placebo.||Units on a scale||Standard Deviation|Mean
748942|NCT00538850|Secondary|Summed Pain Intensity Differences (SPID) at 5, 10, 15, 45, and 60 Minutes After Dosing|Pain intensity was assessed by the participant using a 0-100 mm visual analog scale where 0 represented “no pain” and 100 represented “worst possible pain” at 0 (baseline, beginning of the pain episode), 5, 10, 15, 30, 45 and 60 minutes after each dose of study medication during each breakthrough pain episode. The pain intensity difference was defined as the difference in pain intensity at the various time points versus time 0 (baseline). SPID was calculated as the time-weighted sum of the PID scores using the following formulas: SPID5=(5*PID5), SPID10=(5*PID5)+(5*PID10), SPID15=(5*PID5)+(5*PID10)+(5*PID15), SPID30=(5*PID5)+(5*PID10)+(5*PID15)+(15*PID30), SPID45=(5*PID5)+(5*PID10)+(5*PID15)+(15*PID30)+(15*PID45), SPID60=(5*PID5)+(5*PID10)+(5*PID15)+(15*PID30) +(15*PID45) +(15*PID60). The minimum and maximum SPID scores were -500 to 500, -1000 to 1000, -1500 to 1500, -3000 to 3000, -4500 to 4500, and -6000 to 6000, respectively. A higher score indicates less pain.|Baseline (time 0, beginning of each pain episode) through 60 minutes after dosing for each pain episode|Intent-to-treat (ITT) population: All participants in the double-blind treatment period who received at least 1 dose of study medication and had at least 1 pain measurement. 4 of the 96 participants in the ITT population were excluded from analysis because they did not have at least 1 dose of study medication and 1 dose of placebo.||Units on a scale||Standard Deviation|Mean
748943|NCT00538850|Primary|Summed Pain Intensity Differences (SPID) at 30 Minutes After Dosing (SPID30)|Pain intensity was assessed by the participant using a 0-100 mm visual analog scale where 0 represented “no pain” and 100 represented “worst possible pain” at 0 (baseline, beginning of the pain episode), 5, 10, 15, and 30 minutes after each dose of study medication during each breakthrough pain episode. The pain intensity difference was defined as the difference in pain intensity at the various time points versus time 0 (baseline). SPID30 was calculated as the time-weighted sum of the PID scores using the following formula: SPID30=(5*PID5)+(5*PID10)+(5*PID15)+(15*PID30). The minimum and maximum SPID30 scores were -3000 and 3000. A higher score indicates less pain.|Baseline (time 0, beginning of each pain episode) through 30 minutes after dosing for each pain episode|Intent-to-treat (ITT) population: All participants in the double-blind treatment period who received at least 1 dose of study medication and had at least 1 pain measurement. 4 of the 96 participants in the ITT population were excluded from analysis because they did not have at least 1 dose of study medication and 1 dose of placebo.||Units on a scale||Standard Deviation|Mean
748944|NCT00538863|Primary|Percentage of Patients That Experienced 1 or More Adverse Events||Baseline to end of the study (up to 116 days)|Safety population: All patients who received study medication.||Percentage of patients|||Number
748945|NCT00538902|Secondary|Mean Change in the SF-36 Health Survey Index Mental Component Summary (MCS) Through Week 92 of the Open-Label Period|SF-36 (v.2) is a standardized health survey consisting of 36 questions to measure functional health status. The SF-36 score has two components: physical (PCS) and mental (MCS). Summary scores are calculated using the following 8 scales: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The score for a component is an average of the individual question scores, which are scaled 0 (not functioning) to 100 (highest functioning). An increase in SF-36 PCS or MCS indicates improved health status.|Baseline, Week 0, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92|Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Open-Label period). Participant numbers are reduced from the Double-Blind period as not all enrolled participants in the DB period also enrolled in the OL period.||score on a scale||Standard Deviation|Mean
748946|NCT00538902|Secondary|Mean Change in the SF-36 Health Survey Index Physical Component Summary (PCS) Through Week 92 of the Open-Label Period|SF-36 (v.2) is a standardized health survey consisting of 36 questions to measure functional health status. The SF-36 score has two components: physical (PCS) and mental (MCS). Summary scores are calculated using the following 8 scales: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The score for a component is an average of the individual question scores, which are scaled 0 (not functioning) to 100 (highest functioning). An increase in SF-36 PCS or MCS indicates improved health status.|Baseline, Week 0, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92|Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Open-Label period). Participant numbers are reduced from the Double-Blind period as not all enrolled participants in the DB period also enrolled in the OL period.||score on a scale||Standard Deviation|Mean
750403|NCT00552240|Secondary|Number of Participants With HIV Viral Load < 50 Copies/ml at Week 6 of Treatment|Results within time windows, patients on-treatment|baseline to week 6|All treated patients||Participants|||Number
748947|NCT00538902|Secondary|Mean Change in the SF-36 Health Survey Index Physical Component Summary (PCS) and Mental Component Summary (MCS) at Week 12 of the Double-Blind Period|SF-36 (v.2) is a standardized health survey consisting of 36 questions to measure functional health status. The SF-36 score has two components: physical (PCS) and mental (MCS). Summary scores are calculated using the following 8 scales: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The score for a component is an average of the individual question scores, which are scaled 0 (not functioning) to 100 (highest functioning). An increase in SF-36 PCS or MCS indicates improved health status.|Baseline, Week 12|Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Double-Blind portion of the study), Observed cases included.||score on a scale||Standard Deviation|Mean
748948|NCT00538902|Secondary|Mean Change in the Disability Index of the Health Assessment Questionnaire (HAQ) Through Week 92 of the Open-Label Period|HAQ is a self-reported, subject-oriented outcome measure. The Standard Disability Index of HAQ for a subject is calculated as the mean of the following 8 category scores (range: 0-3): dressing and grooming, rising, eating, walking, hygiene, reach, grip, and activities. The score of each category is calculated as the maximum of the scores for the questions of that category. The Disability Index cannot be computed if the patient does not have scores for at least 6 categories. A decrease in the Disability Index indicates an improvement in disease (0 = no difficulties).|Baseline, Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92|Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Open-Label period. Participant numbers are reduced from the Double-Blind period as not all enrolled participants in the DB period also enrolled in the OL period.||score on a scale||Standard Deviation|Mean
748949|NCT00538902|Secondary|Mean Change in the Disability Index of the Health Assessment Questionnaire (HAQ) Scores From Baseline to Week 12 of the Double-Blind Period|HAQ is a self-reported, subject-oriented outcome measure. The Standard Disability Index of HAQ for a subject is calculated as the mean of the following 8 category scores (range: 0-3): dressing and grooming, rising, eating, walking, hygiene, reach, grip, and activities. The score of each category is calculated as the maximum of the scores for the questions of that category. The Disability Index cannot be computed if the patient does not have scores for at least 6 categories. A decrease in the Disability Index = improvement in disease (0 = no difficulties). Week 12 = end of Double-Blind period.|Baseline, Week 12|Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the double-blind portion of the study), Last Observation Carried Forward (LOCF).||score on a scale||Standard Deviation|Mean
748950|NCT00538902|Secondary|Mean Change in Patient's Global Assessment of Disease Activity (Visual Analog Scale [VAS]) Through Week 92 of the Open-Label Period|Visual analog scale (VAS) was used for the physician's (PhGA) and patient's (PGA) global assessment of disease activity and the patient's assessment of pain. PhGA assessed the patient's current status, PGA assessed status within the last 24 h, and patient's assessment of pain assessed pain status during the last week. All 3 assessments were scored on a 100 mm horizontal scale. The scores range from 0 (no symptoms) to 100 (maximum symptoms); therefore lower VAS scores represent a better disease state.|Baseline, Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92|Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Open-Label period. Participant numbers are reduced from the Double-Blind period as not all enrolled participants in the DB period also enrolled in the OL period.||mm||Standard Deviation|Mean
748951|NCT00538902|Secondary|Mean Change in Patient's Assessment of Pain (Visual Analog Scale [VAS]) Through Week 92 of the Open-Label Period|Visual analog scale (VAS) was used for the physician's (PhGA) and patient's (PGA) global assessment of disease activity and the patient's assessment of pain. PhGA assessed the patient's current status, PGA assessed status within the last 24 h, and patient's assessment of pain assessed pain status during the last week. All 3 assessments were scored on a 100 mm horizontal scale. The scores range from 0 (no symptoms) to 100 (maximum symptoms); therefore lower VAS scores represent a better disease state.|Baseline, Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92|Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Open-Label period. Participant numbers are reduced from the Double-Blind period as not all enrolled participants in the DB period also enrolled in the OL period.||mm||Standard Deviation|Mean
748952|NCT00538902|Secondary|Mean Change in Physician's Global Assessment of Disease Activity (Visual Analog Scale [VAS]) Through Week 92 of the Open-Label Period|Visual analog scale (VAS) was used for the physician's (PhGA) and patient's (PGA) global assessment of disease activity and the patient's assessment of pain. PhGA assessed the patient's current status, PGA assessed status within the last 24 h, and patient's assessment of pain assessed pain status during the last week. All 3 assessments were scored on a 100 mm horizontal scale. The scores range from 0 (no symptoms) to 100 (maximum symptoms); therefore lower VAS scores represent a better disease state.|Baseline, Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92|Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Open-Label period. Participant numbers are reduced from the Double-Blind period as not all enrolled participants in the DB period also enrolled in the OL period.||mm||Standard Deviation|Mean
748953|NCT00538902|Secondary|Mean Change in Visual Analog Scale (VAS) Score at Week 12 of the Double-Blind Period|Visual analog scale (VAS) was used for the physician's (PhGA) and patient's (PGA) global assessment of disease activity and the patient's assessment of pain. PhGA assessed the patient's current status, PGA assessed status within the last 24 h, and patient's assessment of pain assessed pain status during the last week. All 3 assessments were scored on a 100 mm horizontal scale. The scores range from 0 (no symptoms) to 100 (maximum symptoms); therefore lower VAS scores represent a better disease state. Week 12 = end of Double-Blind period.|Baseline, Week 12|Intent-to-Treat (ITT) population (all subjects who received at least 1 dose of study drug during the double-blind period), Last Observation Carried Forward (LOCF).||mm||Standard Deviation|Mean
749027|NCT00540293|Primary|Percent of Subjects in the Total and Each Cardiovascular Risk Group Achieving Low Density Lipoprotein-cholesterol (LDL-C) Target After 8 Weeks of Treatment.|LDL-C Responders by visit and by risk group - full analysis set (FAS)|Week 8|N=number of subjects in the Full Analysis Set (FAS). Number of Participants Analyzed represents subjects with on-treatment lipid measures (missing values imputed by last observation carried forward)||Percentage of participants||95% Confidence Interval|Mean
748954|NCT00538902|Secondary|Mean Change in Swollen Joint Count (SJC) Through Week 92 of the Open-Label Period|"Sixty-eight or 66 joints or regions (34 or 32 per body side [hip joints excluded]) were assessed by pressure and joint manipulation on physical examination for tender joint count (TJC) or swollen joint count (SJC), respectively. Both joint tenderness and swelling were classified as either present (1), absent (0), replaced (9), or no assessment (NA). The Total TJC or SJC was derived as the sum of all 1s evaluated; the range for TJC and SJC were 0 - 68 and 0 - 66, respectively. The higher the joint count, the worse the rheumatoid arthritis. Week 12 = end of Double-Blind period."|Baseline, Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92|Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Open-Label period. Participant numbers are reduced from the Double-Blind period as not all enrolled participants in the DB period also enrolled in the OL period.||Joints||Standard Deviation|Mean
748955|NCT00538902|Secondary|Mean Change in Tender Joint Count (TJC) Through Week 92 of the Open-Label Period|"Sixty-eight or 66 joints or regions (34 or 32 per body side [hip joints excluded]) were assessed by pressure and joint manipulation on physical examination for tender joint count (TJC) or swollen joint count (SJC), respectively. Both joint tenderness and swelling were classified as either present (1), absent (0), replaced (9), or no assessment (NA). The Total TJC or SJC was derived as the sum of all 1s evaluated; the range for TJC and SJC were 0 - 68 and 0 - 66, respectively. The higher the joint count, the worse the rheumatoid arthritis. Week 12 = end of Double-Blind period."|Baseline, Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92|Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Open-Label period. Participant numbers are reduced from the Double-Blind period as not all enrolled participants in the DB period also enrolled in the OL period.||Joints||Standard Deviation|Mean
748956|NCT00538902|Secondary|Mean Change in Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Week 12 of the Double-Blind Period|"Sixty-eight or 66 joints or regions (34 or 32 per body side [hip joints excluded]) were assessed by pressure and joint manipulation on physical examination for tender joint count (TJC) or swollen joint count (SJC), respectively. Both joint tenderness and swelling were classified as either present (1), absent (0), replaced (9), or no assessment (NA). The Total TJC or SJC was derived as the sum of all 1s evaluated; the range for TJC and SJC were 0 - 68 and 0 - 66, respectively. The higher the joint count, the worse the rheumatoid arthritis. Week 12 = end of Double-Blind period."|Baseline, Week 12|Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the double-blind portion of the study), Last Observation Carried Forward (LOCF).||Joints||Standard Deviation|Mean
748957|NCT00538902|Secondary|Number of Participants Achieving American College of Rheumatology (ACR)70 Response Through Week 92 of Open-Label Period|American College of Rheumatology (ACR) criteria improvement in a subject's disease condition versus Baseline consisting of 70% (ACR70) reduction in tender or swollen joint counts and 20/50/70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.|Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92|Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Open-Label period. Participant numbers are reduced from the Double-Blind period as not all enrolled participants in the DB period also enrolled in the OL period.||Participants|||Number
748958|NCT00538902|Secondary|Number of Participants Achieving American College of Rheumatology (ACR)50 Response Through Week 92 of Open-Label Period|American College of Rheumatology (ACR) criteria improvement in a subject's disease condition versus Baseline consisting of 50% (ACR50) reduction in tender or swollen joint counts and 20/50/70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.|Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92|Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Open-Label period. Participant numbers are reduced from the Double-Blind period as not all enrolled participants in the DB period also enrolled in the OL period.||Participants|||Number
748959|NCT00538902|Secondary|Number of Participants Achieving American College of Rheumatology (ACR)20 Response Through Week 92 of Open-Label Period|American College of Rheumatology (ACR) criteria improvement in a subject's disease condition versus Baseline consisting of 20% (ACR20) reduction in tender or swollen joint counts and 20/50/70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.|Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92|Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Open-Label period. Participant numbers are reduced from the Double-Blind period as not all enrolled participants in the DB period also enrolled in the OL period.||Participants|||Number
748960|NCT00538902|Secondary|Number of Participants Achieving American College of Rheumatology (ACR)50/70 at Week 12 of the Double-Blind Period|American College of Rheumatology (ACR) criteria improvement consisting of 50% or 70% (ACR50/70) reduction in tender or swollen joint counts and 50% or 70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit. Week 12 = end of Double-blind period.|Week 12|Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the double-blind portion of the study), non-responder imputation (NRI; missing ACR responses imputed as non-responders).||Participants|||Number
749028|NCT00540293|Secondary|Change From Baseline in High Sensitive Circulating C-reactive Protein (Hs-CRP) After 4 and 8 Weeks of Treatment|Median baseline, and change from baseline in hs-CRP by risk group - FAS|4 and 8 weeks|Laboratory Population: 10 subjects from FAS (n=425) were not included in Laboratory Population (n=415).||mg/dL||95% Confidence Interval|Median
750404|NCT00552240|Secondary|Number of Participants With HIV Viral Load < 50 Copies/ml at Week 4 of Treatment|Results within time windows, patients on-treatment|baseline to week 4|All treated patients||Participants|||Number
748961|NCT00538902|Primary|Number of Participants With American College of Rheumatology (ACR)20 at Week 12 of the Double-Blind Period|American College of Rheumatology (ACR) criteria improvement consisting of 20% (ACR20) reduction in tender or swollen joint counts and 20% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit. Week 12 = end of Double-Blind period.|Week 12|Intent-to-treat population (ITT): all randomized subjects who received at least 1 dose of study drug during the double-blind portion of the study.||Participants|||Number
748962|NCT00538915|Primary|Serious Bacterial Infections (SBIs) Compared to Historical Control Data.|Serious bacterial infections (SBIs) rate per person-years, including bacteremia/sepsis, bacterial meningitis, osteomyelitis/septic arthritis, bacterial pneumonia and visceral abscess.|One year|63 subjects enrolled, received treatment and included in the Safety population. 5 subjects excluded from the Intent To Treat (ITT) population due to significant, excessive protocol violations and an insufficient number of infusions to elicit the intended effect.||SBIs Per Total Person-Years|||Number
748963|NCT00538980|Secondary|Change in JAK2 Allele Burden|To determine if quantitative change in JAK2 expression occurs as measured by quantitative pyrosequencing. Analysis was not completed because the study was terminated early due to lack of efficacy.|JAK2 analysis will be performed at baseline and month 3.||||||
748964|NCT00538980|Secondary|Change in Cytogenetics|To determine change in cytogenetics if initially abnormal. Analysis was not completed because the study was terminated early due to lack of efficacy.|Cytogenetics analysis will be performed at baseline and month 6.||||||
748965|NCT00538980|Secondary|Changes in Marrow Cellularity, Reticulin and Fibrous Content|To determine changes in marrow cellularity, reticulin and fibrous content. Analysis was not completed because the study was terminated early due to lack of efficacy.|Bone marrow analysis will be performed at baseline and month 6.||||||
748966|NCT00538980|Primary|Change in Performance Status and Development of Side Effects and Complications|To determine change in performance status and development of side effects and complications in patients treated under this protocol. Analysis was not completed because the study was terminated early due to lack of efficacy.|Patients will evaluated weekly for the first month, then every two weeks forr months 2 and 3, and monthly thereafter.||||||
748967|NCT00538980|Primary|Effect of Dasatinib on the Platelet Count and the Stabilization of Hematocrit When Restored by Phlebotomy to Normal Range|To evaluate the effect of dasatinib on the platelet count and the stabilization of hematocrit when restored by phlebotomy to normal range (HCT <45% for men, <42% for women). Analysis was not completed because the study was terminated early due to lack of efficacy.|Lab tests will be performed weekly for the first month, then every 2 weeks for months 2 and 3 and monthly thereafter.||||||
748968|NCT00539006|Secondary|Comparision of Mean Change From Baseline Over Treatment Periods in Nighttime Reflective Total Nasal Symptom Scores (N-rTNSS) for Active Drug Nasal Sprays Versus Placebos|Reflective Total Nasal Symptom scores (rTNSS) symptoms of rhinorrhea, nasal congestion, nasal itching, sneezing using scale of: 0=none, 1=mild, 2=moderate, 3=severe; maximum score=12.|Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21)|Intent-to-Treat (ITT) population consisted of all participants who were randomized to study treatment, and was to form the basis of all summaries of background, demographic, safety, and efficacy data.||Scores on a scale||Standard Error|Mean
748969|NCT00539006|Secondary|Comparision of Mean Change From Baseline Over Treatment Periods in Daytime Reflective Total Nasal Symptom Scores (D r-TNSS) for Active Drug Nasal Sprays Versus Placebos|Reflective Total Nasal Symptom scores (rTNSS) symptoms of rhinorrhea, nasal congestion, nasal itching, sneezing using scale of: 0=none, 1=mild, 2=moderate, 3=severe.|Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21)|Intent-to-Treat (ITT) population consisted of all participants who were randomized to study treatment, and was to form the basis of all summaries of background, demographic, safety, and efficacy data.||Scores on a scale||Standard Error|Mean
748970|NCT00539006|Secondary|Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Gentleness of Mist|Participants assessed preference over gentleness of mist for the nasal sprays used during the 2 treatment periods|End of Crossover Period (Day 22)|Intent-to-Treat (ITT) population. These measures are from the product preference questionnaire given at the end of the study. Because questionnaires were comparative in nature, only subjects who completed both treatment periods were included in the analyses. In addition, there are small variations due to non-response for individual questions.||Participants|||Number
748971|NCT00539006|Primary|Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Scent/Odor|"Participants assessed preference of scent/odor for the nasal sprays used during the treatment periods by answering I prefer product 1 for spray used during Treatment Period 1 or I prefer product 2 for spray used during Treatment Period 2. Participant could also choose I have no preference."|End of Crossover Period (Day 22)|Intent-to-Treat (ITT) population consisted of all participants who were randomized to study treatment, and was to form the basis of all summaries of background, demographic, safety, and efficacy data.||Participants|||Number
748972|NCT00539006|Primary|Comparison of Mean Change From Baseline in Daily Reflective Total Nasal Symptom Score (rTNSS) Over Treatment Periods of Active Drug Nasal Sprays Versus Placebos|Reflective Total Nasal Symptom scores (rTNSS) symptoms of rhinorrhea, nasal congestion, nasal itching, sneezing using scale of: 0=none, 1=mild, 2=moderate, 3=severe; maximum score=12. The mean of AM and PM scores were used.|Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21)|Intent-to-Treat (ITT) population consisted of all participants who were randomized to study treatment, and was to form the basis of all summaries of background, demographic, safety, and efficacy data.||Scores on a scale||Standard Error|Mean
748973|NCT00539006|Secondary|Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Ease of Use|"Participants assessed preference over ease of use for the nasal sprays used during the treatment periods by answering I prefer product 1 for spray used during Treatment Period 1 or I prefer product 2 for spray used during Treatment Period 2. Participant could also choose I have no preference."|End of Crossover Period (Day 22)|Intent-to-Treat (ITT) population. These measures are from the product preference questionnaire given at the end of the study. Because questionnaires were comparative in nature, only subjects who completed both treatment periods were included in the analyses. In addition, there are small variations due to non-response for individual questions.||Participants|||Number
748974|NCT00539006|Secondary|Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Leaking Out of Nose/Down Throat|"Participants assessed preference over leaking out of nose/down throat for the nasal sprays used during the treatment periods by answering I prefer product 1 for spray used during Treatment Period 1 or I prefer product 2 for spray used during Treatment Period 2. Participant could also choose I have no preference."|End of Crossover Period (Day 22)|Intent-to-Treat (ITT) population. These measures are from the product preference questionnaire given at the end of the study. Because questionnaires were comparative in nature, only subjects who completed both treatment periods were included in the analyses. In addition, there are small variations due to non-response for individual questions.||Participants|||Number
748975|NCT00539032|Primary|Percentage of Participants With ≥ 4-Fold Rise in Titers for the Menactra® Vaccine Serogroups A, C, Y, and W-135.||Day 28 Post-vaccination|4-Fold rise in Menactra® vaccine antibodies were evaluated in the per-protocol population.||Percentage of Participants|||Number
748976|NCT00539032|Primary|Geometric Mean Titers (GMTs) as Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination.||Day 0 (baseline or pre-vaccination) and Day 28 Post-vaccination|Geometric mean titers by serum bactericidal assay were determined in the per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
748977|NCT00539032|Other Pre-specified|Number of Participants Reporting At Least 1 Solicited Injection Site or Systemic Reaction Post-Vaccination With Menactra®|Solicited injection Site reactions: Pain, erythema, and swelling; Solicited systemic reactions: Fever, headache, malaise and myalgia.|Days 0-7 Post-vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat safety population.||Participants|||Number
748978|NCT00539864|Secondary|Percentage of Participants With Seroprotection|Percentage of participants with (HAI titer greater than or equal to 40) at Day 28|Day 28 following immunization at Day 0|||Percentage of participants||95% Confidence Interval|Number
748979|NCT00539864|Secondary|Percentage of Participants With Seroconversion|Percentage of participants with greater than or equal to a 4-fold rise in Hemagglutination-Inhibition Assay (HAI) titer over Day 0 at Day 28 following immunization|Day 28 following immunization at Day 0|All randomized subjects who received study vaccine and who had day 0 and day 28 HAI titers||Percentage of participants|Participants|95% Confidence Interval|Number
748980|NCT00539864|Primary|Number of Participants With Reactogenicity (Solicited) Adverse Events (AEs)|Solicited reactogenicity events included injection site pain, bruising, erythema and swelling. Solicited systemic AEs included fatigue, chills, arthralgias, myalgias, headache and nausea.|Reactogenicity days 0-7 following immunization; other AEs days 0-28 following immunization|Safety population included all randomized subjects who received a dose of study vaccine.||participants|||Number
748981|NCT00539864|Secondary|Evaluation and Comparison of Immunogenicity of FluBlok and TIV in Healthy Adults 50-64 Years of Age.|Immunogenicity was assessed by measuring the difference in values in Hemagglutination-Inhibition Assay (HAI) titers in participants from Day 0 to Day 28, using Geometric Mean Titers (GMTs). The GMTs from the FluBlok and TIV groups were then compared.|Day 0 and Day 28|All randomized subjects who received study vaccine and had Day 0 and Day 28 HAI titers||HAI Titers||95% Confidence Interval|Geometric Mean
748982|NCT00539942|Secondary|Incidence of Untoward Effects With Arixtra|Adverse events will be evaluated to determine untoward effects.|21 days|Unable to analyze data.||participants|||Number
748983|NCT00539942|Primary|Comparison of Deep Venous Thromboembolism (DVT) Using Intermittent Compression Devices With and Without Arixtra|Deep venous thromboembolism (DVT) rates are determined from lower extremity doppler ultrasound measurements.|21 days|Planned Intention to Treat analysis but was unable to complete due to inadequate number of subjects enrolled.||participants|||Number
748984|NCT00539994|Other Pre-specified|Percentage of Participants With Nasal Recolonization With S. Aureus on Study Days 12 and 33 Who Were Persistant Carriers Who Tested Positive in the Pharyngeal Region on Days 12 and 33 But Negative in the Nasal Region on Day 7 or Days 7 and 12|All subjects were positive (pos.) for S. Aureus in the Pharyngeal region on days 12 or 33 (D12 and D33) and Negative (neg.) in the Nasal Region on day 7 (D7) or days 7 and 12. Pharyngeal culture, PC; nasal culture, NC.|Days 7, 12, and 33.|Per Protocol Population: Persistant Carriers of the Intent-to-Treat (ITT) Population who Tested Positive on Screening Visit 1, 2, 3, and those who were Positive for Pharynegeal Carriage on Day 12 and Day 33 then recolonized.||Percentage of participants|||Number
748985|NCT00539994|Secondary|Number of Participants With a Nasal Culture Negative for MRSA (Methicillin-resistant S. Aureus)|The number of participants who tested negative for MRSA on days 7, 12, and 33.|Days 7, 12, or 33.|Screening Eligibility Population: only participants who provided nasal cultures at Days 7, 12, and 33 were analyzed.||participants|||Number
748986|NCT00539994|Secondary|Prevalence of S. Aureus Nasal and Pharyngeal Carriage by Visit.|All participants were assessed for nasal and pharyngeal carriage at Screening Visits 1, 2, and 3. Participants were randomized into the study only if they had positive cultures at screening visit 1 and screening visit 2 and/or screening visit 3. Day 1 data were collected only for those participants who were randomized into the study.|Screening Visits 1 (Day -42 to Day -14), 2 (Day -11 to Day -4), and 3 (Day -11 to Day -4) and Day 1|Screening Population (participants who had anterior nares swab obtained for S. aureus culture) was analyzed for Screening Visit (SV) 1. Only subjects who had positive cultures for S. aureus at SV 1 were allowed to continue to SV 2 and 3. The Safety Population (participants who received at least one dose of study drug) was analyzed at Day 1.||participants|||Number
748987|NCT00539994|Secondary|Percentage of Participants With Nasal Recolonization With S. Aureus on Study Days 12 and 33 Who Were Persistant Carriers Who Tested Positive in the Pharyngeal Region on Days 12 and 33 But Negative in the Nasal Region on Day 7 or Days 7 and 12|Percentage of subjects that were recolonized on Day 12 (D12) and Day 33 (D33) that were negative (neg.) for S. Aureus in the Pharyngeal region on days 12 or 33 and Negative in the Nasal Region on day 7 (D7) or days 7 and 12. Pharyngeal culture, PC; nasal culture, NC.|Days 7, 12, and 33|Per Protocol Population: Persistent Carriers of the Intent-to-Treat (ITT) Population who Tested Positive on Screening Visit 1, 2, 3 and those who were NEGATIVE for Pharynegeal Carriage on Day 12 and Day 33 then recolonized.||Percentage of participants|||Number
749071|NCT00540449|Secondary|Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <400 Copies/ml) at Week 48||Week 48|The ITT analysis set was considered the primary efficacy analysis set.||Participants|||Number
748988|NCT00539994|Secondary|Percentage of Participants With Eradication of S. Aureus Nasal Carriage at Each Post Treatment Visit Stratified by Pharyngeal Carriage Status|Comparison of nasal S. aureus eradication in persistent carrier subjects on 7, 12, and 33 days after treatment stratified by S. aureus carriage in the pharyngeal area|Days 1, 7, 12, and 33|Per Protocol Population: Persistent Carriers of the Intent-to-Treat (ITT) Population who Tested Positive on Screening Visit 1, 2, 3, and who were Persistent Nasal carriers who were both positive and negative carriers of S. aureus in the Pharyngeal region.||Percentage of participants|||Number
748989|NCT00539994|Secondary|Percentage of Participants With Eradication of S. Aureus Nasal Carriage at Days 7 and 33 Who Were Categorized as Persistent Carriers of S. Aureus|Subjects who tested positive as persistent carriers of S. Aureus who on Days 7 and 33 are negative and have eradicated of S. aureus.|Days 7 and 33|Per Protocol Population: Persistent Carriers of the Intent-to-Treat (ITT) Population who Tested Positive on Screening Visits 1, 2 and 3.||Percentage of participants|||Number
748990|NCT00539994|Secondary|Plasma Retapumulin Pharmacokinetic Parameters by Treatment at Day 5|Tmax - The time after administration of a drug when the maximum plasma concentration is reached, when the rate of absorption equals the rate of elimination.|Day 5|Per Protocol Population of Intent-to-treat||hours||Standard Deviation|Mean
748991|NCT00539994|Secondary|Plasma Retapumulin Pharmacokinetic Parameters, Tmax, by Treatment at Days 1 and 3|Tmax - The time after administration of a drug when the maximum plasma concentration is reached, when the rate of absorption equals the rate of elimination.|Days 1 and 3|Per Protocol Population of Intent-to-treat||hours||Standard Deviation|Mean
748992|NCT00539994|Primary|Percentage of Participants With Eradication of S. Aureus Nasal Carriage at Day 12 Who Were Categorized as Persistent Carriers of S. Aureus|Subjects who tested positive as persistent carriers of S. Aureus who on day 12 are negative and have been eradicated of S. Aureus.|Day 12|Per Protocol Population: Persistent Carriers of the Intent-to-Treat (ITT) Population who Tested Positive on Screening Visit 1, 2 and 3.||Percentage of participants|||Number
748993|NCT00539994|Primary|Plasma Retapumulin Pharmacokinetic Parameters by Treatment at Day 5 Evaluated by Plasma Cmax After Dosing|Cmax is the peak serum concentration. Low value was not calculable, and high value was 2.74 ng/mL|Day 5|Pharmacokinetic Concentration Population - included all subjects who underwent plasma PK sampling||ng/mL||Standard Deviation|Mean
748994|NCT00539994|Primary|Plasma Retapumulin Pharmacokinetic Parameters by Treatment at Days 1 and 3 Evaluated by Plasma Cmax After Dosing|Cmax is the peak serum concentration. Low value was not calculable, and High value was 2.74 ng/mL.|Days 1 and 3|Pharmacokinetic Concentration Population - included all subjects who underwent plasma PK sampling||ng/mL||Standard Deviation|Mean
748995|NCT00539994|Primary|Plasma Retapumulin Pharmacokinetic Parameters by Treatment at Day 5 Evaluated by Plasma AUC After Dosing|Area under the plasma concentration curve (AUC) is used to calculate drug clearance and bioavailability using plasma concentration and time curve.|Day 5|Pharmacokinetic Concentration Population - included all subjects who underwent plasma PK sampling||ng.h/mL||Standard Deviation|Mean
748996|NCT00539994|Primary|Plasma Retapumulin Pharmacokinetic Parameters by Treatment at Days 1 and 3 Evaluated by Plasma AUC After Dosing|Area under the plasma concentration curve (AUC) is used to calculate drug clearance and bioavailability using plasma concentration and time curve.|Days 1 and 3|Pharmacokinetic (PK) Concentration Population - included all subjects who underwent plasma PK sampling||ng.h /mL||Standard Deviation|Mean
748997|NCT00540046|Secondary|Expulsion|IUD was not removed by provider but fell out on its own.|6 months|The analysis here includes the 64/71 A/Immediate arm and 26/88 B/Delayed arm who received an IUD. In the A/Immediate arm, 5 women changed their mind post-randomization and in 2 cases, the provider chose not to place it. In the B/Delayed arm, reasons included not returning for follow-up visit, changing mind, and provider not wanting to place IUD.||percentage of expulsions|||Number
748998|NCT00540046|Primary|Use of IUD|Number of participants using Copper T380A IUD 6 months after surgery|6 months|||participants|||Number
748999|NCT00540124|Secondary|Change From Baseline to 12 Week Endpoint in Uroflowmetry Parameters - Voided Urine Volume (Vcomp)|Vcomp, defined as the volume of voided urine (measured in milliliters [mL]).|baseline, 12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward.||milliliters||Standard Deviation|Mean
749000|NCT00540124|Secondary|Change From Baseline to 12 Week Endpoint in Uroflowmetry Parameters - Peak Urine Flow Rate (Qmax) and Mean Urine Flow Rate (Qmean)|Qmax: defined as the peak urine flow rate (measured in milliliters per second [mL/second] using a standard calibrated flowmeter); and Qmean, defined as the mean urine flow rate (measured in mL/second using a standard calibrated flowmeter).|baseline, 12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward.||milliliters per second||Standard Deviation|Mean
749001|NCT00540124|Secondary|Change From Baseline to 12 Week Endpoint in Voids With Terminal Micturition Dribble and Post Micturition Dribble Per Week Based on Median as Reported by Patient Voiding Dribble Diary|A patient-completed diary that measures terminal dribble (dribble in the end of urination) and post-micturition dribble (dribble after urination).|baseline, 12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward.||average number per week||Standard Deviation|Mean
749002|NCT00540124|Secondary|Change From Baseline to 12 Week Endpoint in Total Urinary Incontinence Episodes Per Week Based on Median as Reported in Patient Voiding Dribble Diary|A patient-completed diary that measures urinary incontinence (UI) (leaks). Number of UI leaks per week are reported.|baseline, 12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward.||average number per week||Standard Deviation|Mean
749014|NCT00540228|Secondary|Number of Subjects With Any, Grade 3 and Related Medically Significant Conditions (MSCs).|MSCs were defined as conditions prompting emergency room visits or physician visits that were not related to common diseases or routine visits. Any = incidence of a particular symptom regardless of grade intensity or relationship with the study vaccination. Grade 3 = event which prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination|From Day 0 to Day 180|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects.||subjects|||Number
749003|NCT00540124|Secondary|Change From Baseline to 12 Week Endpoint in Total, Waking, and Sleeping Voids (Average Number Per Week) Based on Median as Reported in Patient Voiding Dribble Diary|Patient-completed diary that measures daytime frequency (waking voids) and nocturia (sleeping voids). Average number of waking voids per week, average number of sleeping voids per week, and average number of total voids (sleeping+waking) per week are reported.|baseline, 12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward.||average number per week||Standard Deviation|Mean
749004|NCT00540124|Secondary|Clinician Global Impression of Improvement (CGI-I) Combined Categories - Frequencies|"Measures clinician's perception of patient improvement of illness at the time of assessment compared with start of treatment. Scores range from 1 (very much better) to 7 (very much worse). Scores were combined to provide number of participants whose clinician indicated they were worse (scores of 5, 6, or 7), no change (score of 4), or better (scores of 1, 2, or 3)."|12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward.||participants|||Number
749005|NCT00540124|Secondary|Patient Global Impression of Improvement (PGI-I) Combined Categories - Frequencies|"A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). Scores were combined to provide number of participants who indicated they were worse (scores of 5, 6, or 7), no change (score of 4), or better (scores of 1, 2, or 3)."|12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward.||participants|||Number
749006|NCT00540124|Secondary|Change From Baseline to 12 Week Endpoint in Benign Prostatic Hyperplasia Impact Index (BPH-II)|The BPH-BII is a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores range of 0 to 13; higher scores represent increased perceived impact of BPH-LUTS on overall health. If scores for any component question were missing for a visit, BPH-BII was reported as missing for that visit.|baseline, 12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward.||units on a scale||Standard Deviation|Mean
749007|NCT00540124|Secondary|Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Nocturia Subscore|IPSS Question 7 is used to assess the frequency of nocturia. Scores range from 0 (low frequency of nocturia) to 5 (high frequency of nocturia).|baseline, 4, 8, and 12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward.||units on a scale||Standard Deviation|Mean
749008|NCT00540124|Secondary|Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Obstructive Subscore|The IPSS voiding (obstructive) subscore is defined as sum of scores for Questions 1, 3, 5, and 6 of the IPSS. If scores for any of these questions are missing for a visit, the IPSS voiding subscore will be reported as missing for that visit. Subscore totals range from 0 to 20; higher scores are indicative of greater obstruction.|baseline, 4, 8, and 12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward.||units on a scale||Standard Deviation|Mean
749009|NCT00540124|Secondary|Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Irritative Subscore|The IPSS storage (irritative) subscore is defined as sum of scores for Questions 2, 4, and 7 of the IPSS. If scores for any of these questions are missing for a visit, the IPSS storage subscore will be reported as missing for that visit. Subscore totals range from 0 to 15; higher scores are indicative of greater irritation.|baseline, 4, 8, and 12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward.||units on a scale||Standard Deviation|Mean
749010|NCT00540124|Secondary|Change From Baseline to 4 Week and 8 Week Endpoints in International Prostate Symptom Score (IPSS) Total Score|The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.|baseline, 4 and 8 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
749011|NCT00540124|Primary|Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Total Score|The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.|baseline, 12 weeks|Primary analysis was performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward.||units on a scale||Standard Deviation|Mean
749012|NCT00540228|Secondary|Number of Subjects With Serious Adverse Events (SAEs).|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Day 0 to Day 180|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects.||subjects|||Number
749013|NCT00540228|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented normal activity Related = unsolicited AE assessed by the investigator as related to the vaccination.|During the 21-day (Days 0-20) post vaccination period|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects.||subjects|||Number
749015|NCT00540228|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.|Assessed solicited general symptoms were arthralgia, fatigue, fever [oral temperature above (>) 38.0 degrees Celsius (°C)], headache, myalgia, nausea and shivering. Any = incidence of a particular symptom regardless of grade intensity or relationship with the study vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0°C. Related = symptom considered by the investigator to have a causal relationship to study vaccination.|During the 7-day (Days 0-6) post vaccination period|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects.||subjects|||Number
749016|NCT00540228|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms.|Assessed solicited local symptoms were ecchymosis, pain, redness and swelling at injection site. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal everyday activity. Grade 3 redness/swelling/ecchymosis = redness/swelling/ecchymosis spreading beyond 50 millimeters (mm) of the injection site.|During the 7-day (Days 0-6) post vaccination period|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects.||subjects|||Number
749017|NCT00540228|Secondary|Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.|The mean was calculated for CD8 T-cells (per million CD8 T-cells) producing at least two different cytokines (All Doubles), at least CD40L, at least INF gamma (IFN-γ), at least IL2 and at least TNF alpha (TNF-α).|At Days 0, 21 and 180|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||cells||Standard Deviation|Mean
749018|NCT00540228|Secondary|Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.|The mean was calculated for CD4 T-cells (per million CD4 T-cells) producing at least two different cytokines (All Doubles), at least CD40L, at least INF gamma (IFN-γ), at least IL2 and at least TNF alpha (TNF-α).|At Days 0, 21 and 180|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||cells||Standard Deviation|Mean
749019|NCT00540228|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The 4 influenza strains assessed were A/Wisconsin (WISC), B/Malaysia (MALA), A/Brisbane (BRIS) and B/Florida (FLOR). The seropositivity cut-off assay was 1:28.|At Days 0 and 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||titers||95% Confidence Interval|Geometric Mean
749020|NCT00540228|Secondary|Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.|A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 3 influenza strains assessed were A/Solomon Islands (SOLO), A/Wisconsin (WISC) and B/Malaysia (MALA).|At Days 0, 21 and 180|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||subjects|||Number
749021|NCT00540228|Secondary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 3 influenza strains assessed were A/Solomon Islands (SOLO), A/Wisconsin (WISC) and B/Malaysia (MALA).|At Days 21 and 180|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||fold increase||95% Confidence Interval|Geometric Mean
749022|NCT00540228|Secondary|Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 influenza strains assessed were A/Solomon Islands (SOLO), A/Wisconsin (WISC) and B/Malaysia (MALA).|At Days 21 and 180|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||subjects|||Number
749023|NCT00540228|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/Solomon Islands (SOLO), A/Wisconsin (WISC) and B/Malaysia (MALA). The seropositivity cut-off assay was 1:10. The results for Day 0 and Day 21 are the primary efficacy variables.|At Days 0, 21 and 180|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||titers||95% Confidence Interval|Geometric Mean
749024|NCT00540293|Secondary|Percent Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment.|Percent changes from baseline in monocyte chemoattractant protein (MCP-1), interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-alpha) by risk group - FAS|8 weeks|Laboratory Population: 17 subjects from FAS (n=425) were not included in Laboratory Population (n=408).||percent||95% Confidence Interval|Median
749025|NCT00540293|Secondary|Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment.|Median baseline, and change from baseline in monocyte chemoattractant protein (MCP-1), interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-alpha) by risk group - FAS|Baseline, and 8 weeks|Laboratory Population: 17 subjects from FAS (n=425) were not included in Laboratory Population (n=408).||pg/dL||95% Confidence Interval|Median
749172|NCT00541658|Secondary|Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 13, ITT Population||Week 13|ITT Population.||Percent Change||95% Confidence Interval|Least Squares Mean
749029|NCT00540293|Secondary|Percent of Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin.|LDL-C responders at week 8 by titration status and risk groups - FAS, efficay evaluation (EVAL), and FAS (no last observation carried forward, LOCF)|8 weeks|Laboratory Population: 10 subjects from FAS (n=425) were not included in Laboratory Population (n=415).||percentage of participants||95% Confidence Interval|Mean
749030|NCT00540293|Secondary|Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin.|LDL-C responders at week 8 by titration status and risk groups - FAS, efficacy evaluation (EVAL), and FAS (no last observation carried forward, LOCF)|8 weeks|Laboratory Population: 10 subjects from FAS (n=425) were not included in Laboratory Population (n=415).||Participants|||Number
749031|NCT00540293|Secondary|Percent Changes From Baseline in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment|Mean percent changes from baseline in lipid parameters by risk group - FAS. HDL-C: high density lipoprotein-cholesterol; TC: total cholesterol; TG: triglyceride|weeks 4 and 8|Laboratory Population: 10 subjects from FAS (n=425) were not included in Laboratory Population (n=415).||Percent||95% Confidence Interval|Mean
749032|NCT00540293|Secondary|Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment|Mean baseline, change and percent change from baseline in lipid parameters by risk group - FAS. HDL-C: high density lipoprotein-cholesterol; TC: total cholesterol; TG: triglyceride|Weeks 4 and 8|||mg/dL (ratio for Scalar)||95% Confidence Interval|Mean
749033|NCT00540293|Secondary|Percent of Subjects in the Total Group and Each Cardiovascular Risk Group Achieving LDL-C Target After 4 Weeks of Treatment.|LDL-C Responders by visit and by risk group - FAS|Week 4|||Percent subjects achieved LDL-C target||95% Confidence Interval|Mean
749034|NCT00540423|Secondary|Pharmacokinetics of SB-497115-GR, Vz/F|VZ/F: VZ is the volume of distribution based on the terminal phase, and F is the fraction of dose absorbed.|Week 9 or 10|PK Population. Data from one participant were abnormal; this participant was excluded from this analysis.||Liters||Standard Deviation|Mean
749035|NCT00540423|Secondary|Pharmacokinetics of SB-497115-GR, CL/F|CL/F: CL is an estimate of the total body clearance, and F is the fraction of dose absorbed.|Week 9 or 10|PK Population. Data from one participant were abnormal; this participant was excluded from this analysis.||L/hr (Liters/hour)||Standard Deviation|Mean
749036|NCT00540423|Secondary|Pharmacokinetics of SB-497115-GR, AUClast and AUC0-24|"AUC is area under a concentration vs. time curve.
AUC0-24 (Area under the plasma concentration-time curve between 0 to 24 hrs) is calculated using the following equation:
AUC0-24= AUClast + Clast × (1 - e-λz × [24-tlast])/λz. AUClast is AUC (area under a curve) computed to the last observation. Clast is concentration of last observation."|Week 9 or 10|PK Population. Data from one participant were abnormal; this participant was excluded from this analysis.||hr*ng/mL||Standard Deviation|Mean
749037|NCT00540423|Secondary|Pharmacokinetics of SB-497115-GR, Lambda z|Lambda z is first order rate constant associated with the terminal portion of the plasma concentration curve.|Week 9 or 10|PK Population. Data from one participant were abnormal; this participant was excluded from this analysis.||1/hour||Standard Deviation|Mean
749038|NCT00540423|Secondary|Pharmacokinetics of SB-497115, t1/2|t1/2 is half life based on the terminal phase|Week 9 or 10|PK Population. Data from one participant were abnormal; this participant was excluded from this analysis.||Hours||Standard Deviation|Mean
749039|NCT00540423|Secondary|Pharmacokinetics of SB-497115-GR, Tmax|tmax: Time when Cmax was achieved|Week 9 or 10|PK Population||Hours||Full Range|Median
749040|NCT00540423|Secondary|Pharmacokinetics of SB-497115-GR, Cmax|Cmax: Peak plasma concentration of SB-497115|Week 9 or 10|Pharmacokinetic (PK) Population: all participants with valid PK data following SB-497115-GR treatment||ng/mL (nanograms/milliliter)||Standard Deviation|Mean
749041|NCT00540423|Secondary|Mean Number of Days of Concomitant ITP Medication Use Per Month|Cumulative number of days for which a participant received ITP medication during the treatment/total treatment period (months). Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety.|Weeks 1 through 26|Full Analysis Set||Days||Standard Deviation|Mean
749042|NCT00540423|Secondary|Percentage of Participants Who Received Rescue Treatment for ITP|Rescue treatment for ITP is treatment applied to participants at high bleeding risk, such as those undergoing platelet transfusion or dose increase of steroids. Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety.|Weeks 1 through 26|Full Analysis Set||Percentage of participants|||Number
749043|NCT00540423|Secondary|Percentage of Participants With a Reduction in Dose and/or Number of Drugs of Concomitant ITP Medications From Baseline|ITP medications are drugs, such as steroids or immunoglobulin, to be used for ITP. Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety.|Baseline through Week 26|Full Analysis Set. Four participants in the Full Analysis Set did not have concomitant ITP medication at Baseline.||Percentage of participants|||Number
749044|NCT00540423|Secondary|Percentage of Participants With Bleeding Episode Since the Last Visit|When abnormal bleeding(s) was found since the last visit, it was recorded as a bleeding episode(s). Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety.|Days 1, 8, 15, 22, 29, 36, and 43; Weeks 10, 14, 18, 22, and 26|Full Analysis Set||Percentage of participants|||Number
749173|NCT00541658|Secondary|Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 104 / Endpoint, ITT Population||Week 104 / Endpoint|ITT Population. Last Observation Carried Forward at Week 104.||Percent Change||95% Confidence Interval|Least Squares Mean
749045|NCT00540423|Secondary|Mean Total Time for Which Participants Maintained Platelet Counts >=50 x 10^9/Liter and <=400 x 10^9/Liter|Total time is measured as the cumulative number of days over which platelet counts were maintained within the target range (>=50 x 10^9/Liter and <=400 x 10^9/Liter). Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety.|Weeks 1 through 26|Full Analysis Set||Days||Standard Deviation|Mean
749046|NCT00540423|Secondary|Mean Maximum Duration for Which Participants Maintained Platelet Counts >=50 x 10^9/Liter and <=400 x 10^9/Liter|Maximum duration is measured as the longest period (days) for which a participant continuously maintained platelet counts within the target range (>=50 x 10^9/Liter and <=400 x 10^9/Liter). Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety.|Weeks 1 through 26|Full Analysis Set||Days||Standard Deviation|Mean
749047|NCT00540423|Secondary|Mean Change From Baseline in Platelet Counts at Each Visit|Change from baseline was calculated as values at Days 8, 15, 22, 29, 36, and 43 and Weeks 10, 14, 18, 22, and 26 minus baseline value. Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety.|Baseline; Days 8, 15, 22, 29, 36, and 43; Weeks 10, 14, 18, 22, and 26|Full Analysis Set||10^9/Liter||Standard Deviation|Mean
749048|NCT00540423|Secondary|Mean Platelet Counts of Participants at Each Visit|Blood taken from peripheral blood vessels was used for the measurement of platelet counts. Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety.|Baseline; Days 8, 15, 22, 29, 36, and 43; Weeks 10, 14, 18, 22, and 26|Full Analysis Set||10^9/Liter||Standard Deviation|Mean
749049|NCT00540423|Secondary|Percentage of Responders at Each Visit|A responder was defined as a participant with a platelet count within the target range (>=50 x 10^9/Liter and <=400 x 10^9/Liter). Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety.|Days 8, 15, 22, 29, 36, and 43; Weeks 10, 14, 18, 22, and 26|Full Analysis Set||Percentage of responders|||Number
749050|NCT00540423|Secondary|Number of Participants at Baseline and Days 8, 15, 22, 29, 36, and 43 of Treatment by Platelet Count Category|Blood taken from peripheral blood vessels was used for the measurement of platelet counts.|Baseline and Days 8, 15, 22, 29, 36, and 43|Full Analysis Set||Participants|||Number
749051|NCT00540423|Secondary|Percentage of Participants With Bleeding Episodes Since the Last Visit|When abnormal bleeding(s) was found since the last visit, it was recorded as a bleeding episode(s).|Days 1, 8, 15, 22, 29, 36, and 43|Full Analysis Set||Percentage of participants|||Number
749052|NCT00540423|Secondary|Mean Change From Baseline in Platelet Counts at Each Visit|Change from baseline was calculated as values at Days 8, 15, 22, 29, 36, and 43 minus baseline value|Baseline and Days 8, 15, 22, 29, 36, and 43|Full Analysis Set||10^9/Liter||Standard Deviation|Mean
749053|NCT00540423|Secondary|Mean Platelet Count at Each Visit|Blood taken from peripheral blood vessels was used for the measurement of platelet counts.|Baseline and Days 8, 15, 22, 29, 36, and 43|Full Analysis Set||10^9/Liter||Standard Deviation|Mean
749054|NCT00540423|Secondary|Percentage of Responders at Each Visit|A responder was defined as a participant with a platelet count within the target range (>=50 x 10^9/Liter and <=400 x 10^9/Liter).|Days 8, 15, 22, 29, 36, and 43|Full Analysis Set||Percentage of responders|||Number
749055|NCT00540423|Primary|Percentage of Participants for Whom at Least 75% of Their Assessments During the Course of 26 Weeks of SB-497115-GR Treatment Met the Definition of Responders|A responder was defined as a participant with a platelet count within the target range (>=50 x 10^9/Liter and <=400 x 10^9/Liter). Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety.|Week 26|Full Analysis Set||percentage of participants|||Number
749056|NCT00540423|Secondary|Number of Participants Assessed as Responders in at Least 4 Assessments Between Weeks 2 and 6|A responder was defined as a participant with a platelet count within the target range (>=50 x 10^9/Liter and <=400 x 10^9/Liter) at at least 4 out of 5 scheduled visits.|Weeks 2 through 6|Full Analysis Set||Participants|||Number
749057|NCT00540423|Primary|Number of Responders at Week 6|A responder was defined as a participant with a platelet count within the target range (>=50 x 10^9/Liter and <=400 x 10^9/Liter).|Week 6|Full Analysis Set: all randomized participants, with the exception of (1) those who did not receive any dose of study medication and (2) those with no valid platelet count measurements on therapy||Participants|||Number
749058|NCT00540436|Secondary|Mean Change From Baseline in B-type Natriuretic Peptide (BNP) Values at Weeks 12 and 24|Change from baseline was calculated as the Week 12 and 24 values minus the baseline value. BNP is a surrogate maker of heart failure and was measured by a central laboratory. Observed data analysis (no imputation techniques).|Baseline and Weeks 12 and 24|Full Analysis Set: Analysis was conducted using observed data only. Some participants were withdrawn before Week 24, or some participants could not be measured at Week 24 in this study.||Nanograms/Liter (ng/L)||Standard Deviation|Mean
749174|NCT00541658|Secondary|Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 104, ITT Population||Week 104|ITT Population.||Percent Change||95% Confidence Interval|Least Squares Mean
749059|NCT00540436|Secondary|Mean Change From Baseline in Pulmonary Vascular Resistance (PVR) at Weeks 12 and 24|PVR is a measure of cardiopulmonary hemodynamics. Change from baseline was calculated as the Week 12 and 24 values minus the baseline value. Observed data analysis (no imputation techniques).|Baseline and Weeks 12 and 24|Full Analysis Set: Analysis was conducted using observed data only. Some participants were withdrawn before Week 24, or some participants could not be measured at Week 24 in this study.||mmHg/L/min||Standard Deviation|Mean
749060|NCT00540436|Secondary|Mean Change From Baseline in Cardiac Output (CO) at Weeks 12 and 24|CO is a measure of cardiopulmonary hemodynamics. Change from baseline was calculated as the Week 12 and 24 values minus the baseline value. Observed data analysis (no imputation techniques).|Baseline and Weeks 12 and 24|Full Analysis Set: Analysis was conducted using observed data only. Some participants were withdrawn before Week 24, or some participants could not be measured at Week 24 in this study.||L/min||Standard Deviation|Mean
749061|NCT00540436|Secondary|Mean Change From Baseline in Cardiac Index (CI) at Weeks 12 and 24|CI is a measure of cardiopulmonary hemodynamics. Change from baseline was calculated as the Week 12 and 24 values minus the baseline value. Observed data analysis (no imputation techniques).|Baseline and Weeks 12 and 24|Full Analysis Set: Analysis was conducted using observed data only. Some participants were withdrawn before Week 24, or some participants could not be measured at Week 24 in this study.||L/min/m2||Standard Deviation|Mean
749062|NCT00540436|Secondary|Mean Change From Baseline in Mean Pulmonary Atery Pressure (mPAP) and Mean Right Atrial Pressure (mRAP) at Weeks 12 and 24|mPAP and mRAP are measures of cardiopulmonary hemodynamics. Change from baseline was calculated as the Week 12 and 24 values minus the baseline value. Observed data analysis (no imputation techniques).|Baseline and Weeks 12 and 24|Full Analysis Set: Analysis was conducted using observed data only. Some participants were withdrawn before Week 24, or some participants could not be measured at Week 24 in this study.||mmHg||Standard Deviation|Mean
749063|NCT00540436|Secondary|Number of Participants With the Indicated Event, as an Assessment of Time to Clinical Worsening of Pulmonary Arterial Hypertension (PAH) at Week 24, Assessed as the First Occurrence of a Particular Event|Time to clinical worsening is defined as the time from baseline to the first occurrence of death, lung transplantation, hospitalization for PAH treatment, atrial septostomy, or study discontinuation due to change to other PAH treatment. Time to clinical worsening is measured as the number of participants who experienced these events during 24 weeks.|Week 24|Full Analysis Set: : all participants registered, with the exception of those who had not received any dose of the investigational product and those who had no efficacy assessment after administration of the investigational product||Participants|||Number
749064|NCT00540436|Secondary|Number of Participants With a Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 12 and 24|There are four grades for WHO FC (class I = none, Class IV = most severe). The WHO FC indicates the severity of Pulmonary Arterial Hypertension and is an adaptation of the New York Heart Association classification. It was assessed by the investigator. Imputation technique was last observation carried forward.|Weeks 12 and 24|Full Analysis Set||Participants|||Number
749065|NCT00540436|Secondary|Mean Change From Baseline in the Borg Dyspnea Index (BDI) at Weeks 12 and 24|The BDI was calculated by using a 10-point scale (0 = None, 10 = Maximum). Change from baseline was calculated as the Week 12 and 24 values minus the baseline values. The BDI indicates the degree of breathlessness after completion of the 6 minute walk test. The BDI scale was assessed by each participant. Imputation technique was last observation carried forward.|Baseline and Weeks 12 and 24|Full Analysis Set||Points on a scale||Standard Deviation|Mean
749066|NCT00540436|Secondary|Mean Change From Baseline in Six Minutes Walk Distance (6MWD) at Week 24/Withdrawal|Change from baseline was calculated as the Week 24/Withdrawal value minus the basline value. 6MWD was measured by a 6 minute walk test. This test measures the distance that a subject can walk in a period of 6 minutes. Imputation technique was last observation carried forward.|Baseline and Week 24/Withdrawal|Full Analysis Set||Meters||Standard Deviation|Median
749067|NCT00540436|Primary|Mean Change From Baseline in Six Minutes Walk Distance (6MWD) at Week 12|Mean change from baseline was calculated as the Week 12 value minus the baseline value. 6MWD was measured by a 6 minute walk test. This test measures the distance that a subject can walk in a period of 6 minutes.|Baseline and Week 12|Full Analysis Set (FAS): all participants registered, with the exception of those who had not received any dose of the investigational product and those who had no efficacy assessment after administration of the investigational product. Imputation technique was last observation carried forward.||Meters||Standard Deviation|Mean
749068|NCT00540449|Secondary|Number of Participants With Virologic Failure for the Resistance Determination by Emerging Resistance Associated Mutations: First Available On-Treatment Genotypic Data After Failure|Virologic failure for the resistance determinations was defined as lack of virologic response (never having had 2 consecutive plasma viral load <50 copies/mL) and plasma viral load increase of >=0.5 log 10 copies/mL above nadir (i.e., never suppressed), or confirmed loss of virologic response (2 consecutive plasma viral load >=50 copies/mL after having had 2 consecutive plasma viral load <50 copies/mL; i.e., rebounder), or discontinued with a last observed on-treatment plasma viral load >=50 copies/mL after having had 2 consecutive plasma viral load <50 copies/mL. For this study, treatment-emergent reverse transcriptase (RT) resistance associated mutations (RAMs) occurring in at least 2 virologic failures (for at least one treatment group) for the following lists are presented: i) Extended list of Non-nucleoside reverse transcriptase inhibitor (NNRTI RAMs) ii) IAS-USA list of Nucleoside/tide reverse transcriptase inhibitor (N[t]RTI RAMs).|Week 96|"The ITT analysis set was considered the primary efficacy analysis set. Here N (Number of Participants Analyzed) signifies number of Participants who were evaluable (had data) for this outcome measure."||Participants|||Number
749069|NCT00540449|Secondary|Mean Change From Baseline to Week 48 and Week 96 in Absolute and Relative CD4+ Cell Counts (Using Imputed Data)|Change from baseline in CD4+ cell count was imputed in case of missing values: in case of premature discontinuation, data were imputed with the baseline value after discontinuation (i.e. change=0, Non-Completer [NC] = Failure); otherwise last observation carried forward was applied.|Baseline, Week 48, and Week 96|The ITT analysis set was considered the primary efficacy analysis set.||cells per microliter||Standard Deviation|Mean
749070|NCT00540449|Secondary|Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <400 Copies/ml) at Week 96||Week 96|The ITT analysis set was considered the primary efficacy analysis set.||Participants|||Number
749072|NCT00540449|Secondary|Number of Participants With Virological Response (Observed, <50 Copies/ml) at Last On-Treatment Visit (Post-Week 96).|Virological response is defined as (observed) plasma viral load less than 50 human immunodeficiency virus-type 1 (HIV-1) ribonucleic acid (RNA) copies per ml at the last on-treatment visit (post-Week 96).|Variable, ranging from 3 months up to maximum 15 months for TMC278 and 12 months for Efavirenz after the 96-week visit|Participants with at least 1 Post-Week 96 visit were included in the analysis.||Participants|||Number
749073|NCT00540449|Secondary|The Number of Participants With Virological Response (Intent-to-Treat - Snapshot, <50 Copies/ml) at Week 96||Week 96|The Intent-to-Treat analysis set was considered the primary efficacy analysis set.||Participants|||Number
749074|NCT00540449|Secondary|Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies/ml) at Week 96||Week 96|The ITT analysis set was considered the primary efficacy analysis set.||Participants|||Number
749075|NCT00540449|Secondary|The Number of Participants With Virological Response (Intent-to-Treat - Snapshot, <50 Copies/ml) at Week 48|The analysis is based on the last observed viral load (VL) data within the Week 48 window. Virologic response is defined as a VL<50 copies/ml (observed case). Missing VL was considered as non-response. Virologic Failure includes subjects who had VL>=50 copies/ml in the Wk48 window, subjects who discontinued early due to lack or loss of efficacy, subjects who discontinued for reasons other than an adverse event, death or lack or loss of efficacy and at the time of discontinuation had a VL>=50 copies/ml and subjects who had a switch in background regimen that was not permitted by the protocol.|Week 48|The ITT analysis set was considered the primary efficacy analysis set.||Participants|||Number
749076|NCT00540449|Primary|Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies/ml) at Week 48|Virological response is defined as confirmed plasma viral load less than (<) 50 human immunodeficiency virus-1 (HIV-1) (ribonucleic acid [RNA]) copies/milliliter (ml) at Week 48. The TLOVR algorithm was used to derive response. Response needed to be confirmed at 2 consecutive visits and participants who permanently discontinued were considered nonresponders after discontinuation. Resuppression after confirmed virologic failure was considered as failure. Virologic Failure includes participants who were rebounder (confirmed viral load >= 50 copies/ml after being responder) or who were never suppressed (no confirmed viral load <50 copies/ml).|Week 48|The ITT analysis set was considered the primary efficacy analysis set.||Participants|||Number
749077|NCT00540514|Other Pre-specified|Time to Improvement of ≥ Grade 3 Treatment Related Peripheral Neuropathy|"Peripheral neuropathy was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 on the following scale: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening, Grade 5 = death.
Improvement in peripheral neuropathy was evaluated as:
Time to improvement of grade 3 or higher peripheral neuropathy by at least one grade;
Time to improvement of grade 3 or higher peripheral neuropathy to grade 1.
Time to improvement was defined as the time from the first occurrence of grade 3 or higher treatment related neuropathy to improvement, as defined. Participants not experiencing improvement were censored at the last time the participant was evaluated for adverse events."|38 months|Treated population with ≥ grade 3 treatment-related peripheral neuropathy.||days||95% Confidence Interval|Median
749078|NCT00540514|Other Pre-specified|Maximal Degree of Thrombocytopenia Based on Clinical Laboratory Values of Platelet Count|The maximal degree of thrombocytopenia (and myelosuppression) was assessed by the overall nadir of platelet count based on clinical laboratory measurements graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.|38 months|Treated population where laboratory data were available.||× 10^9/L||Standard Deviation|Mean
749079|NCT00540514|Other Pre-specified|Maximal Degree of Neutropenia Based on Clinical Laboratory Values of Absolute Neutrophil Count|The maximal degree of neutropenia (and myelosuppression) was assessed by the overall nadir of absolute neutrophil count (ANC) based on clinical laboratory measurements graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.|38 months|Treated population where laboratory data were available.||× 10^9/L||Standard Deviation|Mean
749080|NCT00540514|Other Pre-specified|Maximal Degree of Anemia Based on Clinical Laboratory Values for Hemoglobin|The maximal degree of anemia (and myelosuppression) was assessed by the overall nadir of hemoglobin levels based on clinical laboratory measurements graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.|38 months|Treated population where laboratory data were available.||g/L||Standard Deviation|Mean
749081|NCT00540514|Other Pre-specified|Percentage of Participants Who Achieved an Objective Confirmed Complete Response or Partial Response by Blinded Radiology Assessment, by Histology|"Antitumor response was defined as the percentage of participants who achieved an objective response (Confirmed Response [CR] or Partial Response [PR]), confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met. Response was based on the blinded radiological review using Response Evaluation Criteria in Solid Tumors (RECIST) response guidelines, Version 1.0.
A complete response was defined as a disappearance of all target and non-target lesions and no new lesions.
Partial response was defined as ≥ 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline SLD, and the persistence of one or more non-target lesions not qualifying for CR or Progressive Disease (the unequivocal progression of existing non-target lesion(s) or appearance of one or more new lesions).
Histology was determined at the time of primary diagnosis."|Objective response was evaluated every 6 weeks until progression or new anti-cancer therapy initiation, up to 22 months.|The intent-to-treat population. N indicates the number of participants in each histology category for each treatment arm respectively.||percentage of participants|||Number
749082|NCT00540514|Secondary|SPARC Status and Correlation With Overall Survival|"The expression and cellular distribution of Secreted Protein Acidic and Rich in cysteine (SPARC) in biopsies of lung tumor was examined by immunohistochemistry using a 2 antibody system by an approved central laboratory and analyzed by 2 pathologists. The following tissue components were scored: tumor cells, fibroblasts, inflammatory cells, acellular stroma/matrix, and blood vessels.
To classify participants into high-SPARC and low-SPARC groups, an average z-score was calculated across variables and classified high-SPARC (average z-scores ≥0) and low-SPARC (average z-scores <0) groups.
SPARC status was then correlated with overall survival (the time from the day of randomization to participant death due to any cause)."|Archival tissue samples were used for SPARC analysis. Survival was assessed for up to 38 months.|SPARC biomarker Population||participants|||Number
749083|NCT00540514|Secondary|Pharmacokinetic (PK) Parameters||Blood samples for PK analyses were taken during Cycle 1 at 0.25, 3.5 and 24 hours post-infusion.|Patients randomized to receive albumin-bound paclitaxel/carboplatin treatment in Canada, Russia, Ukraine and United States had the option to participate in sparse PK sampling in this study. Only 15 participants consented to participate, an insufficient number to support the planned population PK analysis hence these analyses were not performed.|||||
749084|NCT00540514|Secondary|Number of Participants With Adverse Events (AEs)|A Treatment-emergent AE was any AE that began or worsened in grade after the start of study drug through 30 days after the last dose of study drug or end of study whichever is later. Treatment related toxicity was one considered by the investigator to be possibly, probably or definitely related to study drug. AEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 on the following scale: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening, Grade 5 = death. A serious adverse event (SAE) is any untoward medical occurrence at any dose that: is fatal or life-threatening; results in persistent or significant disability or incapacity; requires or prolongs in-patient hospitalization; is a congenital anomaly/birth defect in the offspring of a patient; and conditions not included in the above that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above.|Up to 38 months|Treated population||participants|||Number
749085|NCT00540514|Secondary|Duration of Response in Responding Patients|Duration of response was assessed by progression free survival for participants who achieved a confirmed complete response or partial response based on blinded radiological assessment.|Assessed every 6 weeks, up to 38 months|Intent-to-treat patients with an objective response.||months||95% Confidence Interval|Median
749086|NCT00540514|Secondary|Percentage of Participants With Controlled Disease|Controlled disease was defined as the percentage of participants with stable disease for ≥ 16 weeks or confirmed complete or partial overall response, based on blinded radiological assessment. Stable disease was defined as neither sufficient shrinkage of target lesions to qualify for Partial Response, nor sufficient increase to qualify for Progressive Disease, or the persistence of one or more non-target lesions not qualifying for Complete Response or Progressive Disease.|Assessed every 6 weeks, up to 22 months|Intent-to-treat||percentage of participants||95% Confidence Interval|Number
749087|NCT00540514|Secondary|Overall Participant Survival|Overall survival was defined as the time from the day of randomization to participant death (due to any cause), as assessed by post study follow-up performed monthly for 6 months and every 3 months thereafter for 12 months. All participants who were lost to the follow-up prior to the end of the trial or who completed the 18 month follow up phase were censored at last known time the participant was alive.|Up to 38 months|Intent-to-treat||months||95% Confidence Interval|Median
749088|NCT00540514|Secondary|Progression-free Survival by Blinded Radiology Assessment|"Progression free survival time was defined as the time from the day of randomization to the start of disease progression or death (any cause), whichever occurred first, based on the blinded radiological review response assessment. Progressive disease was defined as a ≥ 20% increase in the SLD of target lesions, taking as reference the nadir SLD recorded since the treatment started, or the presence of one or more new lesions, or the unequivocal progression of existing non-target lesion(s) or appearance of one or more new lesion(s).
Participants who did not have disease progression or had not died were censored at the last visit they were documented as progression free. If palliative radiotherapy or surgery at lesion sites occurred, the participant was censored at the last date without documented progression prior to radiotherapy or surgery. In follow-up, participants who began new therapy prior to progression were censored at the last documented date as progression-free."|Assessed every 6 weeks until progression or death, up to 38 months|Intent-to-treat||months||95% Confidence Interval|Median
749089|NCT00540514|Primary|Percentage of Participants Who Achieved an Objective Confirmed Complete Response or Partial Response by Blinded Radiology Assessment|"Antitumor response was defined as the percentage of participants who achieved an objective response (Confirmed Response [CR] or Partial Response [PR]), confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met. Response was based on the blinded radiological review using Response Evaluation Criteria in Solid Tumors (RECIST) response guidelines, Version 1.0.
A complete response was defined as a disappearance of all target and non-target lesions and no new lesions.
Partial response was defined as ≥ 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline SLD, and the persistence of one or more non-target lesions not qualifying for CR or Progressive Disease (the “unequivocal progression” of existing non-target lesion(s) or appearance of one or more new lesions)."|Objective response was evaluated every 6 weeks until progression or new anti-cancer therapy initiation, up to 22 months.|The intent-to-treat population which includes all randomized patients regardless of whether the patient received any study drug or had any efficacy assessments collected.||percentage of participants||95% Confidence Interval|Number
749090|NCT00540579|Primary|The Safety and Tolerability of Protocol Treatment, Defined as the Percentage of Patients Experiencing Severe or Life-threatening Side Effects Per CTCAE Version 3.0|The relative incidence of Grade 3/4 adverse events from protocol treatment as defined by Common Terminology Criteria for Adverse Events v3.0 (CTCAE)|24 Months|All patients treated with pomalidomide and gemcitabine were assessed for Grade 3/4 toxicities||percentage of patients||95% Confidence Interval|Number
749091|NCT00540579|Primary|Determination of Maximum Tolerated Dose (MTD), The Dose of Study Drug(s) Which Causes <33% of Patients Treated to Experience Unacceptable Side Effects|"Unacceptable side effects or dose-limiting toxicities (DLTs) were defined as follows:
Inability to Complete cycle 1 of therapy due to drug-related toxicity.
> Grade 3 non-hematological drug-related toxicity (excluding alopecia) despite optimal supportive care
Febrile neutropenia (absolute neutrophil count [ANC] <1,000/μL and fever >101° F (38.5° C))
Grade 4 neutropenia that occurs prior to day 21. (Grade 4 neutropenia that occurs after day 21 but resolves within 7 days of the scheduled cycle 2, will not be considered DLT)
Platelet count < 25,000/μL
Inability to initiate Cycle 2, Day 1 therapy within 7 days of scheduled start (i.e. cannot delay the start of Cycle 2 by more than 7 days following the normal 7 day recovery period) due to drug-related toxicity."|6 months|Two patients withdrew consent and were unevaluable for DLT. One patient suffered subdural hematoma (non-treatment related) and was unevaluable for DLT.||milligrams|||Number
749175|NCT00541658|Secondary|Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 52 / Endpoint, ITT Population||Week 52 / Endpoint|ITT Population. Last Observation Carried Forward at Week 52.||Percent Change||95% Confidence Interval|Least Squares Mean
749092|NCT00540592|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 21 and Day 179|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|Between Day 21 and Day 179 after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||Subjects|||Number
749093|NCT00540592|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 0 and Day 20|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|Between Day 0 and Day 20 after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||Subjects|||Number
749094|NCT00540592|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Adverse Events Resulting in Medically Attended Visit Between Day 21 and Day 179|For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and grade 3 was defined as a symptom that prevented normal activity. Related was a symptom assessed by the investigator as causally related to the study vaccination.|Between Day 21 and Day 179 after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||Subjects|||Number
749095|NCT00540592|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Adverse Events Resulting in Medically Attended Visit Between Day 0 and Day 20|For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and grade 3 was defined as a symptom that prevented normal activity. Related was a symptom assessed by the investigator as causally related to the study vaccination.|Between Day 0 and Day 20 after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||Subjects|||Number
749096|NCT00540592|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.|During a 21-day follow-up period (Day 0-20) after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||Subjects|||Number
749097|NCT00540592|Secondary|Duration of Solicited General AEs|Duration was defined as number of days with any grade of general symptoms.|During a 7-day follow-up period (Day 0-6) after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom and completed information on duration in their symptom sheet.||Days||Full Range|Median
749098|NCT00540592|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs|Any Fever was defined as axillary temperature greater than or equal to 38.0 degree centigrade i.e.≥ 38.0°C, grade 3 fever was axillary temperature >40°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relation to vaccination and grade 3 was defined as a general symptom that prevented normal activity. Related was a general symptom assessed by the investigator as causally related to the study vaccination.|During a 7-day follow-up period (Day 0-6) after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.||Subjects|||Number
749099|NCT00540592|Secondary|Duration of Solicited Local AEs|Duration was defined as number of days with any grade of local symptoms.|During a 7-day follow-up period (Day 0-6) after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom and completed information on duration in their symptom sheet.||Days||Full Range|Median
749100|NCT00540592|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)|Grade 3 ecchymosis, pain, redness and swelling was greater than 100 millimeter (mm) i.e. > 100 mm and grade 3 pain was considerable pain at rest that prevented normal everyday activities. Any was occurrence of any local symptom regardless of their intensity grade. Any for ecchymosis, redness and swelling was >20mm.|During a 7-day follow-up period (Day 0-6) after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.||Subjects|||Number
749101|NCT00540592|Secondary|The GM Number of Influenza-specific CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker at Day 180|The markers assessed were CD8-All doubles, CD8-CD40L, CD8-IFNγ, CD8-IL2 and CD8-TNFα. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for persistence for cell mediated immunity (CMI) which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at day 180.||cells per million CD8 T-cells||Standard Deviation|Geometric Mean
749176|NCT00541658|Secondary|Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 52, ITT Population||Week 52|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
749177|NCT00541658|Secondary|Percent Change From Baseline Serum Type-I Collagen C-telopeptide (CTX), Week 26, ITT Population||Week 26|ITT Population.||Percent Change||95% Confidence Interval|Least Squares Mean
749102|NCT00540592|Secondary|The GM Number of Influenza-specific CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker at Days 0 and 21|The markers assessed were Cluster of Differentiation 8-All doubles i.e. CD8-All doubles, CD8-CD40L, CD8-IFNγ, CD8-IL2 and CD8-TNFα. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Days 0 and 21|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity cell mediated immunity (CMI) which included subjects for whom data concerning immunogenicity CMI outcome measures were available at day 21.||cells per million CD8 T-cells||Standard Deviation|Geometric Mean
749103|NCT00540592|Secondary|The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker at Day 180|The markers assessed were CD4-All doubles, CD4-CD40L, CD4-IFNγ, CD4-IL2 and CD4-TNFα. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for persistence for cell mediated immunity (CMI) which included subjects for whom data concerning immunogenicity CMI outcome measures were available at day 180.||cells per million CD4 T-cells||Standard Deviation|Geometric Mean
749104|NCT00540592|Secondary|The Geometric Mean (GM) Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker at Days 0 and 21|The markers assessed were Cluster of Differentiation 4-All doubles i.e. CD4-All doubles, CD4-CD40Ligand(L), CD4-interferon gamma (CD4-IFNγ), CD4-interleukin 2 (CD4-IL2) and CD4-tumor necrosis factor alpha (CD4-TNFα). The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Days 0 and 21|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity cell mediated immunity (CMI) which included subjects for whom data concerning immunogenicity CMI outcome measures were available at day 21.||cells per million CD4 T-cells||Standard Deviation|Geometric Mean
749105|NCT00540592|Secondary|The Number of Subjects Seroprotected to HI Antibodies at Day 180|A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for persistence for HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 180.||Subjects|||Number
749106|NCT00540592|Secondary|The Number of Subjects Seroprotected to HI Antibodies at Day 0 and 21|A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Day 0 and 21|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 21.||Subjects|||Number
749107|NCT00540592|Secondary|HI Antibody Seroconversion Factors at Day 180|Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for persistence for HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 180.||fold increase||95% Confidence Interval|Geometric Mean
749108|NCT00540592|Secondary|HI Antibody Seroconversion Factors at Day 21|Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Day 21|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 21.||fold increase||95% Confidence Interval|Geometric Mean
749109|NCT00540592|Secondary|The Number of Subjects Seroconverted to HI Antibodies at Day 180|A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for persistence for HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 180.||Subjects|||Number
749110|NCT00540592|Secondary|The Number of Subjects Seroconverted to HI Antibodies at Day 21|A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Day 21|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 21.||Subjects|||Number
749111|NCT00540592|Secondary|HI Antibody Titers at Day 180|Antibody titers were expressed as GMTs in all the vaccine groups. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for persistence for HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 180.||titer||95% Confidence Interval|Geometric Mean
749112|NCT00540592|Secondary|HI Antibody Titers at Day 0 and Day 21|Antibody titers were expressed as GMTs in all the vaccine groups. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Day 0 and 21|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 21.||titer||95% Confidence Interval|Geometric Mean
749113|NCT00540592|Primary|Haemagglutination Inhibition (HI) Antibody Titers|Antibody titers were expressed as Geometric mean titers (GMTs) against each of the 3 vaccine strains in greater than or equal to 65 years age groups only. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Day 21|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 21.||titer||95% Confidence Interval|Geometric Mean
749114|NCT00540644|Secondary|Quality of Life Using the FACT-G Data|"Change from baseline FACT-G scores. The quality of life questionnaire (FACT-G) was given at various timepoints during the study. The values for change from baseline to endpoint are provided.
Physical Well-Being (PWB; sum of 7 items, point range 0-28); Social/Family Well-Being (SWB, sum of 7-items, point range 0-28); Emotional Well-Being (EWB; sum of 6-items, point range 0-24); Functional Well-Being (FWB; sum of 7-items, point range 0-28) ; Fact-G score=sum of PWB, SWB, EWB, FWB, point range 0-108. Note: The higher the score, the better the outcome"|baseline and after last cycle (up to 6 cycles)|All patients enrolled and received treatment with a baseline and post-baseline measurement.||scores on a scale||Standard Deviation|Mean
749115|NCT00540644|Secondary|Treatment Related Adverse Events Grade 3 or Higher|Number of unique patients who had treatment related (possible, probable or definite) adverse events that were graded 3 or greater.|Beginning of treatment up to 5 years|All patients enrolled and received treatment.||participants|||Number
749116|NCT00540644|Primary|Response Rate (RR) After 6 Cycles of Therapy Using the Proposed International Myeloma Working Group Uniform Response Criteria|Evaluate the response rate of patients receiving therapy. Patients are considered as having a response if their overall response is Partial Response or better using the proposed International Myeloma Working Group uniform response criteria. The percentage of patients achieving this and the exact 95% confidence interval will be calculated.|After 6 cycles|All patients receiving at least one dose of study drug and having at least one post-baseline visit||percentage of participants||95% Confidence Interval|Number
749117|NCT00540722|Other Pre-specified|Explore Clinical Outcome (Overall Survival) With Changes of Potential Serum Biomarkers, Baseline Tumor Protein Expression and Gene Methylation Status|Archived tumor tissue and 1 serum sample pre first dose and 1 sample anytime during week 2 of cycle 1|1 month|no data to report. Not enough archived tumor tissue and survival outcome did not warrant an analysis of the Pharmacokinetics (PK)|||||
749118|NCT00540722|Secondary|Progression-free Survival Rate, Defined as Patient Who is Alive and Disease Progression Free at the Time of 26-week (6 Months) From First Day of the Treatment|The probability of 6-month progression-free survival will be estimated using binomial distribution.|6 months|||months||95% Confidence Interval|Median
749119|NCT00540722|Secondary|Tumor Response Rate|"Complete response Complete disappearance of all tumor on MRI scan, off all glucocorticoids with stable or improving neurological exam minimum of 4 wks Partial response Greater than or equal 50% reduction in tumor size on MRI, on sable or decreasing glucocorticoids with stable or improving neurological exam for a minimum of 4 wks.
Progressive disease Progressive neurological abnormalities not explained by other causes or greater than 25% increase in size of tumor or if new lesion.
Stable disease Clinical status and MRI does not qualify for complete response, partial response or progression"|3 years|5 patients were not evaluable for response||Participants|||Count of Participants
749120|NCT00540722|Secondary|Percent of Patients With Grade 3 and 4 Adverse Events Related to Treatment|The proportion of patients with serious or life threatening (grade 3 and 4) toxicities will be estimated using NCI CTCAE|3 years|||percentage of participants|||Number
749121|NCT00540722|Primary|Overall Survival|The overall failure rate will be estimated along with 95% confidence intervals. A median time of survival will be estimated using standard methods.|4.5 years|||months||95% Confidence Interval|Median
749122|NCT00540969|Secondary|Average Difference in Pre- and Post-treatment Physical (PCS-8) and Mental (MCS-8) Quality of Life at Week 6 as Measured by the 2 Subscales of the Short Form (SF)-8||at week 6|Not enough patients were accrued. In order to avoid identification of patients, no results will be entered.|||||
749123|NCT00540969|Secondary|Average Difference in Pre- and Post-treatment Average Pain, Pain Relief, and Pain Interference Scores at Week 6 as Measured With the BPI||at week 6|Not enough patients were accrued. In order to avoid identification of patients, no results will be entered.|||||
749124|NCT00540969|Primary|Comparison of Pre- and Post-treatment Worst Pain in 24 Hours at Week 6 as Measured on the Numeric 0 to 10 Brief Pain Inventory (BPI) Scale||at week 6|Not enough patients were accrued. In order to avoid identification of patients, no results will be entered.|||||
749125|NCT00541034|Primary|Overall Objective Response|The major criteria for determination of response to therapy in patients with CLL include physical examination and examination of the peripheral blood and bone marrow. Radiographic studies are not required but those that were abnormal pre-treatment, will be repeated to document the degree of maximal response.|2 years|||Participants|||Count of Participants
749126|NCT00541099|Secondary|Toxicity||1st and 2nd week of each 21 day cycle||||||
749127|NCT00541099|Secondary|Response Rate||Every 8 weeks||||||
749128|NCT00541099|Secondary|Overall Survival||4 weeks after removal from study or until death||||||
749129|NCT00541099|Secondary|Progression-free Survival||6 months when treated with combination of Avastin and weekly docetaxel||||||
749130|NCT00541099|Primary|Survival||6 months when treated with combination of Avastin and weekly docetaxel|||percentage of participants surviving||90% Confidence Interval|Number
749131|NCT00541190|Secondary|Mucociliary Clearance Rate|"Mucociliary clearance rate represents the rate at which the lungs clear an inhaled particulate. Here it specifically represents the percentage of inhaled Technetium 99m sulfur colloid cleared from the lungs over a 60 minute period. This is reported based on whole lung areas to allow comparisons with previous studies."|single measurement|No formal power analysis was performed for this pilot study. Two subjects (one CF, one control) were identified as obvious outliers with whole lung Tc-SC clearance rates more than two standard deviations above the average of the group. These outliers were excluded from further analyses.||percentage lung clearance per hour||Standard Deviation|Mean
749132|NCT00541190|Primary|Absorptive Clearance Rate|The absorptive clearance rate is the percentage of the radiolabeled small molecule DTPA that is cleared through absorption over a 60 minute period. Total DTPA clearance includes absorptive and mucociliary components. The mucociliary component is determined by measuring the clearance of a radiolabeled particle over the same period (Technetium 99m sulfur colloid; Tc-SC), and subtracted from total DTPA clearance in order to determine the absorptive component. Here we specifically report absorption from the central lung zone to capture the behavior within the airways.|single measurement|No formal power analysis was performed for this pilot study. Two subjects (one CF, one control) were identified as obvious outliers with whole lung Tc-SC clearance rates more than two standard deviations above the average of the group. These outliers were excluded from further analyses.||percentage of DTPA absoprtion per hour||Standard Deviation|Mean
749133|NCT00541229|Primary|24-hour Weighted Mean Glucose (WMG)|The 24-hour WMG was calculated as the area under the 24-hour glucose curve (AUC(0-24 hr)) divided by 24 using linear trapezoidal method.|Day 7 of Treatment Period I. Due to a carry-over effect that was observed between treatment periods, efficacy results are presented from Treatment Period I only.|The per-protocol (PP) population consisted of all patients randomized who had a measurement at Day 7 in Treatment Period I and did not have any major protocol violations. Missing data were not imputed.||mg/dL||95% Confidence Interval|Least Squares Mean
749134|NCT00541242|Primary|Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 18|Change from Baseline in mean diurnal IOP. IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the average of the IOP values of both eyes at each time point measured at 8AM, 12PM and 4PM. For each eye, the IOP was either the average of the 2 measurements, or, if a third measurement was required, the median of the 3 measurements. A negative number change from Baseline indicated a reduction in IOP.|Baseline, Week 18|Modified Intent-to-Treat (m-ITT). The m-ITT population included all patients who started the study (randomized) and had at least a baseline and one follow-up visit measurement of IOP after receiving the study medication.||millimeters of mercury (mmHg)||Standard Deviation|Mean
749135|NCT00541242|Primary|Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 12|Change from Baseline in mean diurnal IOP. IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the average of the IOP values of both eyes at each time point measured at 8AM, 12PM and 4PM. For each eye, the IOP was either the average of the 2 measurements, or, if a third measurement was required, the median of the 3 measurements. A negative number change from Baseline indicated a reduction in IOP.|Baseline, Week 12|Modified Intent-to-Treat (m-ITT). The m-ITT population included all patients who started the study (randomized) and had at least a baseline and one follow-up visit measurement of IOP after receiving the study medication.||millimeters of mercury (mmHg)||Standard Deviation|Mean
749136|NCT00541307|Secondary|Device-related Major Adverse Events at 12 Months|If the functioning or characteristics of the device caused or contributed significantly to the adverse event (AE), the AE would be related to the device. Major AEs require significant therapy, including an unplanned increase in the level of care, permanent sequelae, hospitalization, or death.|12 months|||event|||Number
749137|NCT00541307|Secondary|Secondary Patency|Secondary patency is defined as patency in the target lesion maintained by repeat intervention (one more more follow-up procedures) after complete occlusion (blockage) of the treated arterial segment, and also includes patients that have primary and primary assisted patency.|12 months|||percentage of subjects||95% Confidence Interval|Number
749138|NCT00541307|Secondary|Primary Assisted Patency|Primary assisted patency is defined as patency in the target lesion maintained by repeat intervention (one or more follow-up procedures) in an attempt to salvage the stent prior to complete occlusion (blockage) of the treated arterial segment, and also includes patients with primary patency.|12 months|||percentage of subjects||95% Confidence Interval|Number
749139|NCT00541307|Secondary|Proportion of Subjects Who Experience Major Device-related Adverse Events Within the First 30 Days|If the functioning or characteristics of the device caused or contributed significantly to the adverse event,and if they occurred within 30 days of the procedure, they would be considered major adverse events (MAEs). Major AEs require significant therapy, including an unplanned increase in the level of care, permanent sequelae, hospitalization, or death.|30 days|||participants|||Number
749140|NCT00541307|Primary|Primary Patency at 12 Months|Primary patency is defined as no evidence of restenosis (repeat narrowing) or occlusion (total blockage) within the originally treated lesion based on color-coded duplex sonography (color Doppler ultrasound (CDUS). The Peak Systolic Velocity Ratio must be less than 2.5 (PSVR: the result of taking the highest rate of blood flow within the stented region and dividing it by the highest rate of blood flow just above the stented area).|12 months|||percentage of subjects||95% Confidence Interval|Number
749141|NCT00541346|Secondary|Change in Attention Deficit Hyperactivity Disorder Rating Scale IV: Teacher Assessment Total Scores From Baseline to 8-week Follow-up Visit|This instrument is a teacher rating scale used to assess the frequency of ADHD symptoms based on DSM-IV criteria. Raw scores range from 0-54. Higher scores indicate a higher frequency of ADHD symptoms. Raw scores were used in the analyses described below.|Baseline, 8 weeks|Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week assessment was used to handle missing data for a single drop-out participant who left the study after the 2nd follow-up visit.||units on a scale||Standard Deviation|Mean
749142|NCT00541346|Secondary|Change in Pediatric Evaluation Disability Inventory (PEDI) Social Function From Baseline to 8-week Follow-up Visit|The PEDI Caregiver Assistance measures rate the child's function in three domains: Self-care, Mobility, and Social Function. Items are scored 0 (total, where the child is completely dependent on assistance) to 5 (independent, where no assistance is given or required). Scale scores represent summed item scores within each domain. The Social-Function scale score ranges from 0 to 25. A higher score indicates a higher degree of independence in the Social-Function area.|Baseline, 8 weeks|Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week assessment was used to handle missing data for a single drop-out participant who left the study after the 2nd follow-up visit.||units on a scale||Standard Deviation|Mean
749143|NCT00541346|Secondary|Change in Pediatric Evaluation Disability Inventory (PEDI) Caregiver Assistance: Self-Care From Baseline to 8-week Follow-up Visit|The PEDI Caregiver Assistance measures rate the child's function in three domains: Self-care, Mobility, and Social Function. Items are scored 0 (total, where the child is completely dependent on assistance) to 5 (independent, where no assistance is given or required). Scale scores represent summed item scores within each domain. The Self-Care scale score ranges from 0 to 40. A higher score indicates a higher degree of independence in the self-care area.|Baseline, 8 weeks|Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week assessment was used to handle missing data for a single drop-out participant who left the study after the 2nd follow-up visit.||units on a scale||Standard Deviation|Mean
749178|NCT00541658|Secondary|Percent Change From Baseline Serum Type-I Collagen C-telopeptide (CTX), Week 13, ITT Population||Week 13|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
749179|NCT00541658|Secondary|Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 104 / Endpoint, ITT Population||Week 104 / Endpoint|ITT Population. Last Observation Carried Forward at Week 104.||Percent Change||95% Confidence Interval|Least Squares Mean
749144|NCT00541346|Secondary|Change in Family III General Scale Summed Score From Baseline to 8-week Follow-up Visit|The Family Assessment measure is a self-report instrument that provides quantitative indices of family strengths and weaknesses. Each items is rated 0 (strongly agree) to 3 (strongly disagree). The General scale produces seven subscales: task accomplishment, role performance, communication, affective expression, involvement, control and values and norms. The minimum score for each subscale is 0 while the maximum score is 15. Higher raw scores indicate a higher number of family problems reported. A total summed score of all scale scores was used in the analyses described below. The possible range of this total score was 0 to 105. Like the subscales, higher values for this total summed score indicate a higher number of family problems reported.|Baseline, 8 weeks|Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week follow-up assessment was used to handle missing data for a single drop-out participant who left the study after a 2nd follow-up visit.||units on a scale||Standard Deviation|Mean
749145|NCT00541346|Secondary|Change in Lifetime Participation Scale (LPS) Total Scores From Baseline to 8-week Follow-up Visit|The LPS was developed to capture treatment-related improvements in adaptive functioning including quality of life, social development, and emotion regulation. There are 24 items scored using a 4-point Likert frequency scale (0=Never or Seldom, 1=Sometimes, 2=Often, 3=Very Often). A summed scale score (possible range of 0 to 72) was used in the analyses described below. Higher scores indicate more adaptive functioning.|Baseline, 8 weeks|Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week follow-up assessment was used to handle missing data for a single drop-out participant who left the study after a 2nd follow-up visit.||units on a scale||Standard Deviation|Mean
749146|NCT00541346|Secondary|Change in Aberrant Behavior Checklist (ABC) Inappropriate Speech Scores From Baseline to 8-week Follow-up Visit|The ABC is a behavior rating scale administered by the clinician which is designed to measure behavior changes brought about by drug treatment effects. 4 of these items comprise the lethargy/social withdrawal factor. Each item is scored on a 3 point scale where 0 indicates the behavior is not a problem and 3 indicates the behavior problem is severe in degree. The minimum score on this factor is 0 (no behavior problems) while the maximum is 12 ( severe behavior problems).|Baseline, 8 weeks|Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week follow-up assessment was used to handle missing data for a single drop-out participant who left the study after a 2nd follow-up visit.||units on a scale||Standard Deviation|Mean
749147|NCT00541346|Secondary|Change in Aberrant Behavior Checklist (ABC) Stereotypy Scores From Baseline to 8-week Follow-up Visit|The ABC is a behavior rating scale administered by the clinician which is designed to measure behavior changes brought about by drug treatment effects. 7 of these items comprise the stereotypic behavior factor. Each item is scored on a 3 point scale where 0 indicates the behavior is not a problem and 3 indicates the behavior problem is severe in degree. The minimum score on this factor is 0 (no behavior problems) while the maximum score is 21 ( severe behavior problems).|Baseline, 8 weeks|Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week follow-up assessment was used to handle missing data for a single drop-out participant who left the study after a 2nd follow-up visit.||units on a scale||Standard Deviation|Mean
749148|NCT00541346|Secondary|Change in Aberrant Behavior Checklist (ABC) Lethargy Scores From Baseline to 8-week Follow-up Visit|The ABC is a behavior rating scale administered by the clinician which is designed to measure behavior changes brought about by drug treatment effects. 16 of these items comprise the lethargy/social withdrawal factor. Each item is scored on a 3 point scale where 0 indicates the behavior is not a problem and 3 indicates the behavior problem is severe in degree. The minimum score on this factor is 0 (no behavior problems) while the maximum score is 48 ( severe behavior problems).|Baseline, 8 weeks|Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week follow-up assessment was used to handle missing data for a single drop-out participant who left the study after a 2nd follow-up visit.||units on a scale||Standard Deviation|Mean
749149|NCT00541346|Secondary|Change in Aberrant Behavior Checklist (ABC) Irritability Scores From Baseline to 8-week Follow-up Visit|The ABC is a behavior rating scale administered by the clinician which is designed to measure behavior changes brought about by drug treatment effects. 15 of these items comprise the irritability/agitation/crying factor. Each item is scored on a 3 point scale where 0 indicates the behavior is not a problem and 3 indicates the behavior problem is severe in degree. The minimum score on this factor is 0 (no behavior problems) while the maximum score is 45 ( severe behavior problems).|Baseline, 8 weeks|Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week follow-up assessment was used to handle missing data for a single drop-out participant who left the study after a 2nd follow-up visit.||units on a scale||Standard Deviation|Mean
749150|NCT00541346|Secondary|Change in Aberrant Behavior Checklist (ABC) Hyperactivity Scores From Baseline to 8-week Follow-up Visit|The ABC is a behavior rating scale administered by the clinician which is designed to measure behavior changes brought about by drug treatment effects. 16 of these items comprise the hyperactivity, noncompliance factor. Each item is scored on a 3 point scale where 0 indicates the behavior is not a problem and 3 indicates the behavior problem is severe in degree. The minimum score on this factor is 0 (no behavior problems) while the maximum score is 48 ( severe behavior problems).|Baseline, 8 weeks|Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week assessment was used to handle missing data for a single drop-out participant who left the study after the 2nd follow-up visit.||units on a scale||Standard Deviation|Mean
749151|NCT00541346|Primary|Change in Attention Deficit Hyperactivity Disorder Rating Scale - IV (ADHD-RS-IV) Total Score From Baseline to 8-week Follow-up Visit|This instrument is a parent rating scale used to assess the frequency of ADHD symptoms based on DSM-IV criteria. Raw scores range from 0-54. Higher scores indicate a higher frequency of ADHD symptoms. Raw scores were used in the analyses described below.|Baseline, 8 weeks|Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week follow-up assessment was used to handle missing data for a single drop-out participant who left the study after a 2nd follow-up visit.||units on a scale||Standard Deviation|Mean
749180|NCT00541658|Secondary|Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 104, ITT Population||Week 104|ITT Population.||Percent Change||95% Confidence Interval|Least Squares Mean
749181|NCT00541658|Secondary|Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 52 / Endpoint, ITT Population||Week 52 / Endpoint|ITT Population. Last Observation Carried Forward at Week 52.||Percent Change||95% Confidence Interval|Least Squares Mean
749152|NCT00541450|Secondary|Change in Fasting Plasma Glucose (FPG) in Participants Treated With Sitagliptin or Pioglitazone at 12 Weeks|The change in FPG compared to baseline was measured for the participants treated with sitagliptin or pioglitazone at Week 12. Sitagliptin was the only intervention administered to the Sita/Met FDC group during this phase. To calculate Least Squares, the ANCOVA model included a term for treatment and the baseline value as a covariate.|Baseline to 12 weeks|All randomized participants who (1) took at least one dose of study medication; i.e., sitagliptin or pioglitazone 15/30 mg q.d. for the Weeks 0-12; and (2) had a baseline measurement and at least one on-treatment measurement for FPG.||mg/dL||95% Confidence Interval|Least Squares Mean
749153|NCT00541450|Secondary|Change in Fasting Plasma Glucose (FPG) in the Sita/Met FDC or Pioglitazone Groups at 40 Weeks|The change in FPG compared to baseline was measured for the Sita/Met FDC and the pioglitazone groups at Week 40.|Baseline and 40 weeks|All randomized participants who (1) took at least one dose of study medication; i.e., sitagliptin or pioglitazone 15/30 mg q.d. for the Weeks 0-12, and Sita/Met FDC or pioglitazone 45 mg q.d. for the Weeks 0-40 (Phase A and Phase B); and (2) had a baseline measurement and at least one on-treatment measurement for FPG.||mg/dL||95% Confidence Interval|Least Squares Mean
749154|NCT00541450|Secondary|Change in 2-hour Postprandial Glucose (PMG) in Participants Treated With Sitagliptin or Pioglitazone at 12 Weeks|The change in PMG compared to baseline was measured using the Meal Tolerance Test (MTT) for the participants treated with Sitagliptin or Pioglitazone at Week 12. Sitagliptin was the only intervention administered to the Sita/Met FDC group during this phase. To calculate Least Squares, the ANCOVA model included a term for treatment and the baseline value as a covariate.|Baseline to 12 weeks|All randomized participants who (1) took at least one dose of study medication; i.e., sitagliptin or pioglitazone 15/30 mg q.d. for the Weeks 0-12; and (2) had a baseline measurement and at least one on-treatment measurement for PMG.||mg/dL||95% Confidence Interval|Least Squares Mean
749155|NCT00541450|Primary|Change in Hemoglobin A1c (A1C) in Participants Treated With Sitagliptin or Pioglitazone at 12 Weeks|The change in A1C compared to baseline was measured for the participants treated with sitagliptin or pioglitazone at Week 12. Sitagliptin was the only intervention administered to the Sita/Met FDC group during this phase. A1c represents percentage of glycosylated hemoglobin.|Baseline to 12 weeks|All randomized participants who (1) took at least one dose of study medication; i.e., sitagliptin or pioglitazone 15/30 mg q.d. for the Weeks 0-12; and (2) had a baseline measurement and at least one on-treatment measurement for A1C.||percentage of glycosylated hemoglobin||95% Confidence Interval|Least Squares Mean
749156|NCT00541450|Secondary|Change in 2-hour Postprandial Glucose (PMG) in the Sita/Met FDC or Pioglitazone Groups at 40 Weeks|The change in PMG compared to baseline was measured using the Meal Tolerance Test (MTT) for the Sita/Met FDC and the pioglitazone groups at Week 40.|Baseline and 40 weeks|"All randomized participants who (1) took at least one dose of study medication; i.e., sitagliptin or pioglitazone 15/30 mg q.d. for the Weeks 0-12, and Sita/Met FDC or pioglitazone 45 mg q.d. for the Weeks 0-40 (Phase A and Phase B); and
(2) had a baseline measurement and at least one on-treatment measurement for PMG."||mg/dL||95% Confidence Interval|Least Squares Mean
749157|NCT00541450|Primary|Change in Hemoglobin A1c (A1C) in the Sita/Met Fixed-Dose Combination (FDC) or Pioglitazone Groups at 40 Weeks|The change in A1C, compared to baseline for the Sita/Met FDC and the pioglitazone groups at Week 40. A1C represents percentage of glycosylated hemoglobin.|Baseline to 40 weeks|"All randomized participants who (1) took at least one dose of study medication; i.e., sitagliptin or pioglitazone 15/30 mg q.d. for the Weeks 0-12, and Sita/Met FDC or pioglitazone 45 mg q.d. for the Weeks 0-40 (Phase A and Phase B); and
(2) had a baseline measurement and at least one on-treatment measurement for A1C."||percentage of glycosylated hemoglobin||95% Confidence Interval|Least Squares Mean
749158|NCT00541593|Primary|Mortality|"Number of patients who died as a result of the surgery: Death (mortality).
Please note that pain was previously listed as an outcome measure, but this was edited out of this submission and was not tracked as an outcome measure."|One year|Patients who had the diagnosis, qualified anatomically, and were interested in the research study (and who met inclusion criteria but not exclusion criteria) were enrolled.||participants|||Number
749159|NCT00541658|Secondary|Number of Patients With No New Fractured Vertebra, Week 104 / Endpoint||Week 104 / Endpoint|ITT Population. Last Observation Carried Forward at Week 104.||Participants|||Number
749160|NCT00541658|Secondary|Number of Patients With No New Fractured Vertebra, Week 104||Week 104|ITT Population||Participants|||Number
749161|NCT00541658|Secondary|Number of Patients With No New Fractured Vertebra, Week 52 / Endpoint||Week 52 / Endpoint|ITT Population. Last Observation Carried Forward at Week 52.||Participants|||Number
749162|NCT00541658|Secondary|Number of Patients With No New Fractured Vertebra, Week 52||Week 52|ITT Population||Participants|||Number
749163|NCT00541658|Secondary|Number of Patients With at Least One New Fractured Vertebra, Week 104 / Endpoint, ITT Population||Week 104 / Endpoint|ITT Population. Last Observation Carried Forward at Week 104.||Participants|||Number
749164|NCT00541658|Secondary|Number of Patients With at Least One New Fractured Vertebra, Week 104, ITT Population||Week 104|ITT Population.||Participants|||Number
749165|NCT00541658|Secondary|Number of Patients With at Least One New Fractured Vertebra, Week 52 / Endpoint, ITT Population||Week 52 / Endpoint|ITT Population. Last Observation Carried Forward at Week 52.||Participants|||Number
749166|NCT00541658|Secondary|Number of Patients With at Least One New Fractured Vertebra, Week 52||Week 52|ITT Population||Participants|||Number
749167|NCT00541658|Secondary|Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 104 / Endpoint, ITT Population||Week 104 / Endpoint|ITT Population. Last Observation Carried Forward at Week 104.||Percent Change||95% Confidence Interval|Least Squares Mean
749168|NCT00541658|Secondary|Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 104, ITT Population||Week 104|ITT Population.||Percent Change||95% Confidence Interval|Least Squares Mean
749169|NCT00541658|Secondary|Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 52 / Endpoint, ITT Population||Week 52 / Endpoint|ITT Population. Last Observation Carried Forward at Week 52.||Percent Change||95% Confidence Interval|Least Squares Mean
749170|NCT00541658|Secondary|Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 52, ITT Population||Week 52|ITT Population.||Percent Change||95% Confidence Interval|Least Squares Mean
749171|NCT00541658|Secondary|Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 26, ITT Population||Week 26|ITT Population.||Percent Change||95% Confidence Interval|Least Squares Mean
749200|NCT00541658|Secondary|Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 104 / Endpoint, ITT Population|Responder = a patient showing a positive change (>0 g/cm2) in lumbar spine BMD from baseline to the timepoint.|Week 52 / Endpoint|ITT Population. Last Observation Carried Forward at Week 104.||Percentage of Participants|||Number
749201|NCT00541658|Secondary|Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 104, ITT Population|Responder = a patient showing a positive change (>0 g/cm2) in lumbar spine BMD from baseline to the timepoint.|Week 52|ITT Population||Percentage of Participants|||Number
749202|NCT00541658|Secondary|Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 52 / Endpoint, ITT Population|Responder = a patient showing a positive change (>0 g/cm2) in lumbar spine BMD from baseline to the timepoint.|Week 52 / Endpoint|ITT Population. Last Observation Carried Forward at Week 52.||Percentage of Participants|||Number
749203|NCT00541658|Secondary|Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD), Week 52, ITT Population|Responder = a patient showing a positive change (>0 g/cm2) in lumbar spine BMD from baseline to the timepoint.|Week 52|ITT Population.||Percentage of Participants|||Number
749204|NCT00541658|Secondary|Percent Change From Baseline Lumbar Spine BMD at Week 104 / Endpoint, ITT Population||Week 104 / Endpoint|ITT Population. Last Observation Carried Forward at Week 104.||Percent Change||95% Confidence Interval|Least Squares Mean
749205|NCT00541658|Secondary|Percent Change From Baseline Lumbar Spine BMD at Week 104, ITT Population||Week 104|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
749206|NCT00541658|Secondary|Percent Change From Baseline Lumbar Spine BMD, Week 52, ITT Population||Week 52|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
749207|NCT00541658|Secondary|Percent Change From Baseline Lumbar Spine BMD, Week 26, ITT Population||Week 26|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
749208|NCT00541658|Secondary|Percent Change From Baseline Lumbar Spine BMD for Combined 35 mg Delayed-Release Weekly Treatment Group, Week 52 / Endpoint, ITT Population||Week 52 / Endpoint|35 mg group combined delayed-relase following breakfast (DRFB) group with delayed-relase before breakfast (DRBB) group and compared with 5 mg immediate-release before breakfast (IRBB) group. ITT Population. Last Observation Carried Forward at Week 52.||Percent Change||95% Confidence Interval|Least Squares Mean
749209|NCT00541658|Primary|Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Week 52 / Endpoint, ITT Population||52 weeks / Endpoint|Intention-to-Treat (ITT) Population. Last Observation Carried Forward (LOCF) at Week 52.||Percent Change||95% Confidence Interval|Least Squares Mean
749210|NCT00541671|Primary|Number of Patients Who Became Nauseated After IV Opiate Administration.||4 hours post opiate administration|||participants|||Number
749211|NCT00541775|Secondary|2-hour Post-meal Glucose (PMG) at Week 18|The change from baseline is the Week 18 PMG minus the Week 0 PMG.|Baseline and 18 Weeks|The all patients treated population included all patients who took at least one dose of study medication and had both a baseline measurement and at least one post-randomization measurement for this outcome. Missing data were imputed using the last observation carried forward (LOCF) method.||mg/dL||95% Confidence Interval|Least Squares Mean
749212|NCT00541775|Secondary|Fasting Plasma Glucose (FPG) at Week 18|The change from baseline is the Week 18 FPG minus the Week 0 FPG.|Baseline and 18 Weeks|The all patients treated population included all patients who took at least one dose of study medication and had both a baseline measurement and at least one post-randomization measurement for this outcome. Missing data were imputed using the last observation carried forward (LOCF) method.||mg/dL||95% Confidence Interval|Least Squares Mean
749213|NCT00541775|Primary|Hemoglobin A1C (A1C) at Week 18|"A1C is measured as percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.
The study hypothesis comparison was between sitagliptin versus placebo."|Baseline and 18 Weeks|The all patients treated population included all patients who took at least one dose of study medication and had both a baseline measurement and at least one post-randomization measurement for this outcome. Missing data were imputed using the last observation carried forward (LOCF) method.||Percent of glycosylated hemoglobin (A1C)||95% Confidence Interval|Least Squares Mean
749214|NCT00541970|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Throughout the study period, from Month 0 to Month 60.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subjects|||Number
749215|NCT00541970|Secondary|Number of Subjects With Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Month 0 to Month 48.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||subjects|||Number
749216|NCT00541970|Secondary|Number of Subjects With Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity, or are a congenital anomaly/birth defect in the offspring of a study subject.|From Month 0 to Month 7.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||subjects|||Number
749217|NCT00541970|Secondary|Number of Subjects With New Onset of Chronic Diseases (NOCDs)|NOCDs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.|Throughout the study period, from Month 0 to Month 60.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subjects|||Number
749218|NCT00541970|Secondary|Number of Subjects With New Onset of Chronic Diseases (NOCDs)|NOCDs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.|From Month 0 to Month 48.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||subjects|||Number
750405|NCT00552240|Secondary|Number of Participants With HIV Viral Load < 50 Copies/ml at Week 2 of Treatment|Results within time windows, patients on-treatment|baseline to week 2|All treated patients||Participants|||Number
749219|NCT00541970|Secondary|Number of Subjects With New Onset of Chronic Diseases (NOCDs)|NOCDs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.|From Month 0 to Month 7.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||subjects|||Number
749220|NCT00541970|Secondary|Number of Subjects With New Onset of Autoimmune Diseases (NOADs)|NOADs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.|Throughout the study period, from Month 0 to Month 60.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subjects|||Number
749221|NCT00541970|Secondary|Number of Subjects With New Onset of Autoimune Diseases (NOADs)|NOADs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.|From Month 0 to Month 48.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||subjects|||Number
749222|NCT00541970|Secondary|Number of Subjects With New Onset of Autoimmune Diseases (NOADs)|NOADs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.|From Month 0 to Month 7.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||subjects|||Number
749223|NCT00541970|Secondary|Number of Subjects With Medically Significant Conditions (MSCs).|MSCs were defined as: AEs prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. The following did not require reporting as long as they were not considered SAEs and occurred more than 30 days after each vaccination: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities, injury, visits for routine physical examination or visits for vaccination.|Throughout the study period, from Month 0 to Month 60.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subjects|||Number
749224|NCT00541970|Secondary|Number of Subjects With Medically Significant Conditions (MSCs).|MSCs were defined as: AEs prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. The following did not require reporting as long as they were not considered SAEs and occurred more than 30 days after each vaccination: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities, injury, visits for routine physical examination or visits for vaccination.|From Month 0 to Month 48.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||subjects|||Number
749225|NCT00541970|Secondary|Number of Subjects With Medically Significant Conditions (MSCs).|MSCs were defined as: AEs prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. The following did not require reporting as long as they were not considered SAEs and occurred more than 30 days after each vaccination: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities, injury, visits for routine physical examination or visits for vaccination.|From Month 0 to Month 7.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||subjects|||Number
749226|NCT00541970|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|An unsolicited adverse event (AE) is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Grade 3 = an event that prevented normal activity. Related = an event assessed by the investigator as causally related to the study vaccination.|Within 30 days (Day 0-29) after vaccination.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||subjects|||Number
749227|NCT00541970|Secondary|Number of Subjects With Pregnancy Outcomes.|Pregnancy outcomes were ectopic pregnancy, elective termination with no apparent congenital anomaly (ACA), elective termination with congenital anomaly (CA), lost to follow up, pregnancy ongoing, spontaneous abortion with no ACA and live infant with no ACA.|Throughout the study period, from Month 0 to Month 60.|The analysis was performed on pregnant subjects in the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subjects|||Number
749228|NCT00541970|Secondary|Number of Subjects With Pregnancy Outcomes.|Pregnancy outcomes were ectopic pregnancy, elective termination with no apparent congenital anomaly (ACA), elective termination with congenital anomaly (CA), lost to follow up, pregnancy ongoing, spontaneous abortion with no ACA and live infant with no ACA.|From Month 0 to Month 48.|The analysis was performed on pregnant subjects in the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||subjects|||Number
749229|NCT00541970|Secondary|Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)|Seroconversion was defined as the appearance of antibodies (i.e. titers greater than or equal to (≥) cut-off value) in the serum of subjects seronegative before vaccination. Assay cut-off was defined as ≥ 19 ELISA units per milliliter (EL.U/mL). Seronegative subjects are subjects who had an antibody concentration below cut-off value.|At Month 60 of the safety follow-up phase|The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
749275|NCT00535132|Secondary|Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 2 (Observed).|The MSQ is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied).|Week 2|Intent-to-Treat Population with non-missing values at this timepoint||Participants|||Number
749230|NCT00541970|Secondary|Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies|Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). The assay cut-off for Month 60 was defined as ≥ 19 ELISA units per milliliter (EL.U/mL).|At Month 60 of the safety follow-up phase|The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||EL.U/mL||95% Confidence Interval|Geometric Mean
749231|NCT00541970|Secondary|Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)|Seroconversion was defined as the appearance of antibodies (i.e.titers greater than or equal to (≥) cut-off value) in the serum of subjects seronegative before vaccination. Assay cut-off was defined as ≥ 8 ELISA units per milliliter (EL.U/mL) for HPV-16, and 7 EL.U/mL for HPV-18. Seronegative subjects are subjects who had an antibody concentration below cut-off value. Cut-off values were 8 EL.U/mL for antibody concentrations against HPV-16, and 7 EL.U/mL for antibody concentrations against HPV-18.|At Month 12, at Month 18, at Month 24, at Month 36, and at Month 48 during the safety follow-up phase.|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||subjects|||Number
749232|NCT00541970|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.|Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents PLA results.|At Month 7 (M7)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Analysis for this outcome was done on subjects with available results for this outcome measure.||subjects|||Number
749233|NCT00541970|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.|Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents WBC results.|At Month 7 (M7)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented, on subjects with available results.||subjects|||Number
749234|NCT00541970|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.|Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents RBC results.|At Month 7 (M7)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Analysis for this outcome was done on subjects with available results for this outcome measure.||subjects|||Number
749235|NCT00541970|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.|Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents NEU results.|At Month 7 (M7)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Analysis for this outcome was done on subjects with available results for this outcome measure.||subjects|||Number
749236|NCT00541970|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.|Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents MON results.|At Month 7 (M7)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Analysis for this outcome was done on subjects with available results for this outcome measure.||subjects|||Number
749237|NCT00541970|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.|Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents LYM results.|At Month 7 (M7)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Analysis for this outcome was done on subjects with available results for this outcome measure.||subjects|||Number
749238|NCT00541970|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.|Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents ALT results.|At Month 7 (M7)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Analysis for this outcome was done on subjects with available results for this outcome measure.||subjects|||Number
749239|NCT00541970|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.|Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents Hct results.|At Month 7 (M7)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Analysis for this outcome was done on subjects with available results for this outcome measure.||subjects|||Number
749240|NCT00541970|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.|Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents EOS results.|At Month 7 (M7)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Analysis for this outcome was done on subjects with available results for this outcome measure.||subjects|||Number
749241|NCT00541970|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.|Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range.This outcome presents CREA results.|At Month 7 (M7)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Analysis for this outcome was done on subjects with available results for this outcome measure.||subjects|||Number
749242|NCT00541970|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.|Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents BAS results.|At Month 7 (M7)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Analysis for this outcome was done on subjects with available results for this outcome measure.||subjects|||Number
749243|NCT00541970|Secondary|Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies|Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).|At Month 7, 1 month after the last dose of vaccine or placebo.|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||EL.U/mL||95% Confidence Interval|Geometric Mean
749244|NCT00541970|Secondary|Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies|Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).|At Month 12, at Month 18, at Month 24, at Month 36, and at Month 48 during the safety follow-up phase.|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects eligible for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||EL.U/mL||95% Confidence Interval|Geometric Mean
749245|NCT00541970|Secondary|Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies|Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). Groups were stratified into 3 age strata: 9-14, 15-19 and 20-25 years of age at the time of first vaccination. The 15-19 years age stratum in the group receiving the Cervarix vaccine on a 3-dose vaccination schedule was considered an active comparator.|At Month 7, 1 month after the last dose of vaccine or placebo.|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||EL.U/mL||95% Confidence Interval|Geometric Mean
749461|NCT00543296|Secondary|Percentage of Eyes With Improvement in Visual Acuity|Visual acuity was improved by two or more lines from baseline.|baseline to 52 weeks|There were 14 participants studied with a total of 17 eyes implanted. Of the 17 eyes each could require separate adjunctive therapy||percentage of eyes improved|Participants||Number
749246|NCT00541970|Secondary|Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies .|Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). The analysis was performed on the subjects who were administered a 2-dose vaccination schedule.|At Month 3, 1 month after the second dose of vaccine or placebo|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||EL.U/mL||95% Confidence Interval|Geometric Mean
749247|NCT00541970|Primary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, fever (defined as axillary temperature equal or above (≥) 37.5 degrees Celsius (°C), gastrointestinal symptoms, which included nausea, vomiting, diarrhoea and/or abdominal pain, headache, myalgia, rash and urticaria. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature ≥ 39 °C. Grade 3 urticaria = urticaria distributed on at least 4 body areas. Related symptom = symptom assessed by the investigator to be causally related to vaccination.|Within 7 days (Day 0-6) after vaccination.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Analysis for this outcome was done on subjects with available results for this outcome measure.||subjects|||Number
749248|NCT00541970|Primary|Number of Subjects With Report of Any, and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the solicited local symptom irrespective of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling larger than (>) 50 millimeters (mm).|Within 7 days (Day 0-6) after vaccination.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Analysis for this outcome was done on subjects with available results for this outcome measure.||subjects|||Number
749249|NCT00541970|Primary|Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies|Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).|One month after vaccination with the last dose of the Cervarix vaccine (Cervarix 1/Placebo Group: Month 3; Other groups: Month 7).|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||EL.U/mL||95% Confidence Interval|Geometric Mean
749250|NCT00542178|Secondary|Loss of Visual Acuity, Cataract Extraction, or Development or Progression of Macular Edema||Measured at Year 4||05/2013||||
749251|NCT00542178|Primary|Progression of Diabetic Retinopathy of at Least 3 Stages on the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale, or Development of Proliferative Diabetic Retinopathy Necessitating Photocoagulation Therapy or Vitrectomy|Diabetic retinopathy status was defined according to the eye with the highest level on the ETDRS Final Severity Scale for Persons, as follows: no diabetic retinopathy, a level of less than 20; mild diabetic retinopathy, a level of 20; moderate nonproliferative diabetic retinopathy (NPDR), a level above 20 but less than 53; severe diabetic retinopathy, a level of 53 but less than 60; and proliferative diabetic retinopathy (PDR), a level of 60 or higher.|Measured at Year 4|||participants|||Number
749252|NCT00534937|Secondary|Time to Healing of the Venous Stasis Ulcer|Only 2 time points so no calculation details are necessary. The change is calculated as the later time point minus the earlier time point (e.g., 12 weeks minus baseline).|Baseline to 12 weeks|Time to healing can only evaluate the patients that showed healing during the 12 week study therefore the number may not be consistent with other numbers.||days||Standard Deviation|Mean
749253|NCT00534937|Secondary|Percentage Change in Volume of the Affected Limb (-Reduction; +Increase)||12 weeks|Number of participants who completed 12 weeks of treatment without healing. Also limb volume measures must have been present.||percentage of change||Standard Deviation|Mean
749254|NCT00534937|Secondary|Change in Wound Surface Area for Non Healed Subject at 12 Weeks.|Change in wound surface area in cm2 from the initial screening to week 12 for all subject who did not completely healed before or at the 12 week visit.|12 weeks|The participants are those that didn't achieve complete wound healing after 12 weeks of treatment. The change from screening to week 12 in wound surface area is reported.||cm2||Standard Deviation|Mean
749255|NCT00534937|Primary|Complete Healing Rate of Venous Stasis Ulcers|Number of subjects that experience complete healing of the study venous stasis ulcer during the 12 week treatment period.|12 weeks|||participants|||Number
749256|NCT00534976|Secondary|Number of Participants Requiring Rescue Medication at 24 Hours Postdose|This endpoint was defined as the number of participants requiring rescue medication with β-agonist within the 90 mins following exercise challenge. The 24-hour exercise challenges occurred 20-24 hours after the witnessed dose of study medication.|0-90 minutes after the exercise challenge at 24 hours postdose|The analysis of efficacy data was carried out using a completers analysis population. This population included all randomized patients who received the witnessed dose of study drug in both active treatment periods and had at least one post-exercise FEV1 measurement in both active treatment periods.||Participants|||Number
749257|NCT00534976|Secondary|Number of Participants Requiring Rescue Medication at 2 Hours Postdose|This endpoint was defined as the number of participants requiring rescue medication with β-agonist within the 90 mins following exercise challenge. The 2-hour exercise challenges occurred 2 hours after the witnessed dose of study medication.|0-90 minutes after the exercise challenge at 2 hours postdose|The analysis of efficacy data was carried out using a completers analysis population. This population included all randomized patients who received the witnessed dose of study drug in both active treatment periods and had at least one post-exercise FEV1 measurement in both active treatment periods.||participants|||Number
749276|NCT00535132|Secondary|Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to Week 6 (Observed).|The MSQ is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied).|Change from Baseline in MSQ Score at Week 6|Intent-to-Treat Population with non-missing values at this timepoint||Points on a scale||Standard Deviation|Mean
749258|NCT00534976|Secondary|Time to Recovery From Maximum Percent Fall in FEV1 at 24 Hours Post-dose|This endpoint was defined as the duration between the time at which the maximum percent fall in FEV1 occurred & the time when the percent fall in FEV1 returned to within 5% of the pre-exercise baseline for the first time. Spirometry measurements were taken 5 mins prior to each exercise challenge & immediately, 5, 10, 15, 30, 45 & 60 mins after each exercise challenge. If participant had not returned to within 5% of the pre-exercise FEV1 value by 60 mins, then measurements were obtained at 75 & 90 mins. The 24-hour exercise challenges occurred 20-24 hours after the witnessed dose of medication.|0-60 minutes and 0-90 minutes after the exercise challenge at 24 hours postdose|The analysis of efficacy data was carried out using a completers analysis population. This population included all randomized patients who received the witnessed dose of study drug in both active treatment periods and had at least one post-exercise FEV1 measurement in both active treatment periods.||Minutes||Standard Deviation|Mean
749259|NCT00534976|Secondary|Time to Recovery From Maximum Percent Fall in FEV1 at 2 Hours Post-dose|"This endpoint was defined as the duration between the time at which the maximum percent fall in FEV1 occurred & the time when the percent fall in FEV1 returned to within 5% of the pre-exercise baseline for the first time.
Spirometry measurements were taken 5 mins prior to each exercise challenge & immediately, 5, 10, 15, 30, 45, & 60 mins after each exercise challenge. If participant had not returned to within 5% of the pre-exercise FEV1 value by 60 mins, then measurements were obtained at 75 & 90 mins.
The 2-hour exercise challenges occurred 2 hours after the witnessed dose of medication."|0-60 minutes and 0-90 minutes after the exercise challenge at 2 hours postdose|The analysis of efficacy data was carried out using a completers analysis population. This population included all randomized patients who received the witnessed dose of study drug in both active treatment periods and had at least one post-exercise FEV1 measurement in both active treatment periods.||Minutes||Standard Deviation|Mean
749260|NCT00534976|Secondary|Area Under the Curve for FEV1 Percent Fall From Pre-exercise Baseline to 60 Minutes Following Exercise Challenge (AUC0-60 Min) at 24 Hours Post-dose|AUC0-60min was defined as the Area Under the Curve for FEV1 percent change from pre-exercise baseline to the 60 mins following exercise challenge. The area was computed by applying the trapezoidal rule, and including only the area below the pre-exercise baseline. If a participant received β-agonist during the 60 mins after the exercise challenge, the FEV1 measurements obtained after β-agonist administration were excluded and the last pre-rescue FEV1 measurement was carried forward to the 60 mins time point in the calculation of the AUC0-60 min. Smaller values mean greater response to therapy.|Pre-exercise baseline to 60 minutes after the exercise challenge performed 24 hours post-dose|The analysis of efficacy data was carried out using a completers analysis population. This population included all randomized patients who received the witnessed dose of study drug in both active treatment periods and had at least one post-exercise FEV1 measurement in both active treatment periods.||percent fall * minute||Standard Deviation|Mean
749261|NCT00534976|Secondary|Area Under the Curve for FEV1 Percent Fall From Pre-exercise Baseline to 60 Minutes Following Exercise Challenge (AUC0-60 Min) at 2 Hours Post-dose|AUC0-60min was defined as the Area Under the Curve for FEV1 percent change from pre-exercise baseline to the 60 mins following exercise challenge. The area was computed by applying the trapezoidal rule, and including only the area below the pre-exercise baseline. If a participant received β-agonist during the 60 mins after the exercise challenge, the FEV1 measurements obtained after β-agonist administration were excluded and the last pre-rescue FEV1 measurement was carried forward to the 60 mins time point in the calculation of the AUC0-60 min. Smaller values mean greater response to therapy.|Pre-exercise baseline to 60 minutes after the exercise challenge performed 2 hours post-dose|The analysis of efficacy data was carried out using a completers analysis population. This population included all randomized patients who received the witnessed dose of study drug in both active treatment periods and had at least one post-exercise FEV1 measurement in both active treatment periods.||percent fall * minute||Standard Deviation|Mean
749262|NCT00534976|Secondary|Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Post-dose|Maximum Percent Fall in FEV1 was defined as the % change from pre-exercise baseline FEV1 to the lowest FEV1 within 60 mins after exercise. Spirometry measurements were taken 5 mins prior to each exercise challenge and immediately, 5, 10, 15, 30, 45, & 60 mins after each exercise challenge. The 24-hour exercise challenges occurred 20-24 hours after the witnessed dose of study medication. The calculation used to produce the resulted results was [100*(1-(X/Y))] where X= the lowest FEV1 within 60 mins after exercise & Y= pre-exercise baseline FEV1. Smaller values mean greater response to therapy.|Pre-exercise baseline and 0-60 minutes after the exercise challenge performed 24 hours post-dose|The analysis of efficacy data was carried out using a completers analysis population. This population included all randomized patients who received the witnessed dose of study drug in both active treatment periods and had at least one post-exercise FEV1 measurement in both active treatment periods.||percent fall in FEV1||Standard Deviation|Mean
749263|NCT00534976|Primary|Maximum Percent Fall in Forced Expiratory Volume in 1 Second (FEV1) After Exercise Challenge at 2 Hours Postdose|Maximum Percent Fall in FEV1 was defined as the % change from pre-exercise baseline FEV1 to the lowest FEV1 within 60 mins (minutes) after exercise. Spirometry measurements were taken 5 mins prior to each exercise challenge and immediately, 5, 10, 15, 30, 45, & 60 mins after each exercise challenge. The 2-hour exercise challenges occurred 2 hours after the witnessed dose of study medication. The calculation used to produce the results was [100*(1-(X/Y))] where X= the lowest FEV1 within 60 mins after exercise & Y= pre-exercise baseline FEV1. Smaller values mean greater response to therapy.|Pre-exercise baseline and 0-60 minutes after the exercise challenge performed 2 hours post-dose|The analysis of efficacy data was carried out using a completers analysis population. This population included all randomized patients who received the witnessed dose of study drug in both active treatment periods and had at least one post-exercise FEV1 measurement in both active treatment periods.||Percent fall in FEV1||Standard Deviation|Mean
749264|NCT00535002|Primary|Cocaine Craving|"Cocaine-dependent participants were pre-treated with either yohimbine or placebo provided subjective ratings of cocaine craving immediately following cocaine cue exposure.
The scale used was the Within Sessions Ratings Scales (Childress AR, McLellan AT, O'Brien CP (1986) Conditioned responses in a methadone population. A comparison of laboratory, clinic, and natural settings. Journal of Substance Abuse Treatment 3:173-179.) Craving was rated on a scale of 0-10 with 0 being Not At All and 10 being Extremely."|Post cocaine cue exposure|||units on a scale||Standard Deviation|Mean
749462|NCT00543296|Primary|Number of Eyes With Inflammation Recurrence|Number of eyes with inflammation recurrence|5 years|||eye with inflammation|Participants||Number
749265|NCT00535132|Secondary|Modified COVI Anxiety Scale (m-COVI) Change From Baseline to the Week 6 Endpoint|The standard COVI Anxiety Scale is an investigator-assessed measure of the severity of anxiety symptoms on 4 items: verbal report, behavior, somatic symptoms, and relationship to study drug. Each dimension is assessed in 5 to 10 minutes using a 5-point scale as follows: 1=Not at all, 2=Somewhat, 3=Moderately, 4=Considerably, to 5=Very much. For this study, the standard COVI Anxiety Scale was modified to improve psychometric properties by incorporating anchor points for symptom severity, frequency, and duration and for functional impairment. Worst value is 20 and best value is 4.|Change from Baseline to Week 6 LOCF|Intent-to-Treat Population with non-missing values at this timepoint||Points on a scale||Standard Deviation|Mean
749266|NCT00535132|Secondary|Pittsburgh Sleep Quality Index (PSQI) Change From Baseline to the Week 6 Endpoint|The PSQI is a 2-part questionnaire that assesses sleep quality and disturbances in seven domains: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Each domain is rated on a 4-point scale as follows: 0=Not during the past month, 1=Less than once a week, 2=Once or twice a week, 3=Three or more times a week. Total scores range from zero to 21; increasing scores indicate poorer sleep quality and total scores greater than 5 suggest significant sleep disturbance.|Change from Baseline to Week 6 LOCF|Intent-to-Treat Population with non-missing values at this timepoint||Points on a scale||Standard Deviation|Mean
749267|NCT00535132|Secondary|Short Form-36 Health Survey (SF-36) Mental Health Composite Score Change From Baseline to the Week 6 Endpoint|The SF-36 is a well-validated and widely used quality-of-life instrument employed in numerous disease states, including schizophrenia. It is a self-administered survey that measures eight domains of health including: physical functioning, role limitations due to physical health (role-physical), bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems (role-emotional) and general mental health. Scoring of the SF-36 was based on the SF-36 Manual and Interpretation Guide. Worst value is 0 and best value is 100.|Change from Baseline to Week 6 LOCF|Intent-to-Treat Population with non-missing values at this timepoint||Scores on a scale||Standard Deviation|Mean
749268|NCT00535132|Secondary|Short Form-36 Health Survey (SF-36) Physical Health Composite Score Change From Baseline to the Week 6 Endpoint|The SF-36 is a well-validated and widely used quality-of-life instrument employed in numerous disease states, including schizophrenia. It is a self-administered survey that measures eight domains of health including: physical functioning, role limitations due to physical health (role-physical), bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems (role-emotional) and general mental health. Scoring of the SF-36 was based on the SF-36 Manual and Interpretation Guide. Worst value is 0 and best value is 100.|Change from Baseline to Week 6 LOCF|Intent-to-Treat Population with non-missing values at this timepoint||Scores on a scale||Standard Deviation|Mean
749269|NCT00535132|Secondary|Treatment Satisfaction Questionnaire for Medication (TSQM) Global Satisfaction Score Change From Baseline to the Week 6 Endpoint|The TSQM is a 14-item subject-assessed evaluation of treatment medication including 4 factors, Effectiveness (items 1-3), Side Effects (items 4-8), Convenience (items 9-11)and Global Satisfaction (items 12-14). Item 14 states “taking all things into account, how satisfied or dissatisfied are you with this medication?” and utilizes the following responses on a 7-point Likert scale: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 0 and best value is 100.|Change from Baseline to Week 6 LOCF|Intent-to-Treat Population with non-missing values at this timepoint||Points on a scale||Standard Deviation|Mean
749270|NCT00535132|Secondary|Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 6 LOCF.|The MSQ is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied).|Week 6 LOCF|Intent-to-Treat Population with non-missing values at this timepoint||Participants|||Number
749271|NCT00535132|Secondary|Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 6 (Observed).|The MSQ is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied).|Week 6|Intent-to-Treat Population with non-missing values at this timepoint||Participants|||Number
749272|NCT00535132|Other Pre-specified|Clinical Global Impression - Severity (CGI-S) Change From Baseline to Week 6 Endpoint|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a subject. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill subjects. Worst value is 7 and best value is 1."|Change from Baseline to Week 6 LOCF|Intent-to-Treat Population with non-missing values at this timepoint||Points on a scale||Standard Deviation|Mean
749273|NCT00535132|Other Pre-specified|Positive and Negative Syndrome Scale (PANSS) Total Score Change From Baseline to Week 6 Endpoint|The PANSS is a 30-item scale designed to capture numerous symptoms of schizophrenia, including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale as follows: 1=Absent, 2=Minimal, 3=Mild,4=Moderate, 5=Moderate Severe, 6=Severe, 7=Extreme. This scale has been shown to be sensitive to changes associated with medication treatment. In addition to a total score, this assessment yields separate scores along a Positive Syndrome, a Negative Syndrome, and a General Psychopathology Scales. Worst value is 210, best value is 30.|Change from Baseline to Week 6 LOCF|Intent-to-Treat Population with non-missing values at this timepoint||Points on a scale||Standard Deviation|Mean
749274|NCT00535132|Secondary|Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 4 (Observed).|The MSQ is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied).|Week 4|Intent-to-Treat Population with non-missing values at this timepoint||Participants|||Number
749509|NCT00543764|Primary|Operative Time|Length of Time in surgery|3 years|||hours||95% Confidence Interval|Mean
749277|NCT00535132|Secondary|Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to Week 4 (Observed).|The MSQ is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied).|Change from Baseline in MSQ Score at Week 4|Intent-to-Treat Population with non-missing values at this timepoint||Points on a scale||Standard Deviation|Mean
749278|NCT00535132|Secondary|Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to Week 2 (Observed).|The MSQ is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied).|Change from Baseline in MSQ Score at Week 2|Intent-to-Treat Population with non-missing values at this timepoint||Points on a scale||Standard Deviation|Mean
749279|NCT00535132|Primary|Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to the Week 6 Endpoint.|The MSQ is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied).|Change from Baseline in MSQ Score at Week 6 Last Observation Carried Forward (LOCF)|Intent-to-Treat Population with non-missing values at this timepoint||Points on a scale||Standard Deviation|Mean
749280|NCT00535145|Primary|The Difference in the Incidence of Any Adverse Events When Patients Switch Their Antipsychotic From Treatment as Usual (TAU) to Paliperidone ER|Adverse Event summary for both serious adverse events and other adverse events. Please see the Clinical Study Report Synopsis for results on this primary outcome measure or the AE section for a detailed breakdown of each adverse event preferred term in both categories.|Day 1 - Day 62|Safety Analysis Set||Participants|||Number
749281|NCT00535145|Secondary|Personal and Social Performance Score (PSP) Change From Baseline|The PSP (range 1-100) is a validated clinician-rated assessment of functioning. Four areas of functioning (socially useful activities, personal/social relationships, self-care, disturbing/aggressive behaviors) are assessed on a 6-point scale (0=absent to 5=very severe). A transformed score from 1 to 100 is generated from the raw score based on the clinical interpretation of the scores generated in the 4 areas of functioning, with a higher transformed score indicating better function.|Day 1 - Day 62|Includes participants in the efficacy analysis set for with PSP scores available.||Scores on a scale||Standard Deviation|Mean
749282|NCT00535145|Secondary|Clinical Global Impression of Severity (CGI-S) Change From Baseline|The CGI-S (range 1-7) is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness.|Day 1 - Day 62|Efficacy Analysis Set||Scores on a scale||Standard Deviation|Mean
749283|NCT00535145|Secondary|Positive and Negative Symptoms of Schizophrenia (PANSS) Change From Baseline|"The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale (1=Absent, 2=Minimal, 3=Mild, 4=Moderate, 5=Moderate/Severe, 6=Severe, 7=Extreme).The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate more severe neuropsychiatric symptoms of schizophrenia."|Day 1 - Day 62|Efficacy Analysis Set||Scores on a scale||Standard Deviation|Mean
749284|NCT00535223|Secondary|Posttraumatic Cognitions Inventory (PTCI)|This 36 item self-report measure is designed to assess the degree to which a participant agrees with thoughts and beliefs that have been found to be common for individuals who suffer from PTSD. Each item is rated between 1 ( Totally Disagree) to 7 ( Totally Agree). The best score would be 36, indicating that the participant totally did not agree with any of the thoughts that have been associated with PTSD. The worse score would be 252, which would indicate that the participant totally agreed with all of the cognitions that have been associated with PTSD|Pre-treatment, Post-Treatment (16 weeks) and One year Post Treatment|||units on a scale||Standard Deviation|Mean
749285|NCT00535223|Primary|Clinician Administered PTSD Scale (CAPS)|This is an interview regarding the frequency and intensity of each of the 17 PTSD symptoms found in DSM IV and includes information about the degree to which these symptoms are interfering with functioning. This interview includes that clinician rating the participants responses for both the frequency of each symptom and the intensity of each symptom on a scale of zero to four. A score of 0, best possible score, would indicate that the participant is no longer reporting any of the 17 DSM IV symptoms of PTSD. The worse possible score is 136, this would indicate that a participant was reporting every symptoms of PTSD occurring daily or almost daily and that each symptom is causing the most extreme level of distress.|Pre treatment, Post treatment (16 weeks) and One year post treatment|Pre-tx Post-tx 1-yr F.U. N M SD Range N M SD Range N M SD Range GBET 41 82.44 15.09 55-107 41 71.73 20.55 34-105 35 69.29 20.71 24-107 PCGT 40 81.18 14.31 52-109 40 75.43 23.01 18-122 33 71.03 22.80 37-121||units on a scale||Standard Deviation|Mean
749286|NCT00535262|Primary|Reduction of Depression CGI Score (<= 2)|"HAM-D score. Young Mania Scale Life Chart Method Patient Global Impression Symptom Checklist - 90 Quality of Life Enjoyment and Satisfaction Questionnaire
0 participants analyzed due to early termination of study."|8 weeks||||||
749287|NCT00535288|Secondary|Change From Baseline in WHQ Vasomotor Symptoms Domain Score at Week 12|The WHQ is a 36-item, user-friendly, and rapid way of assessing nine domains of physical and emotional health for mid-aged women. Participants self-administered the WHQ questionnaire; scoring is based on a 4-point scale as follows: ‘Yes definitely=1’, ‘Yes sometimes=2’, ‘No not much=3’ and ‘No not at all=4’. Each score is transformed to a value ‘1’ for scores ‘1’ and ‘2’ and to a value ‘0’ for scores ‘3’ and ‘4’. Vasomotor symptoms encompass Items 19 and 27 of the 36 total items. The transformed sums of items 19+27 are divided by 2 to get the score; therefore, the domain ranges from 0 to 1, where lower values are better.|Baseline and Week 12|All participants who received study drug and had valid answers recorded for the WHQ domain for vasomotor symptoms.||Score on a scale||Standard Deviation|Mean
752637|NCT00561600|Secondary|Analysis of Metal Ion Release - Serum Chromium|Serum Chromium|4 months post operative|Metal ion sub-study was limited to two sites. All participants with available data are presented below.||ug/L||Full Range|Median
749288|NCT00535288|Secondary|Change From Baseline in Women's Health Questionnaire (WHQ) Sleep Problems Symptoms Domain Score at Week 12|The WHQ is a 36-item, user-friendly, and rapid way of assessing nine domains of physical and emotional health for mid-aged women. Participants self-administered the WHQ questionnaire; scoring is based on a 4-point scale as follows: ‘Yes definitely=1’, ‘Yes sometimes=2’, ‘No not much=3’ and ‘No not at all=4’. Each score is transformed to a value ‘1’ for scores ‘1’ and ‘2’ and to a value ‘0’ for scores ‘3’ and ‘4’. Sleep problems encompass Items 1, 11, and 29 of the 36 total items. The transformed sums of items 1, 11, and 29 were divided by 3 to get the score; therefore, the domain ranges from 0 to 1, where lower values are better.|Baseline and Week 12|All participants who received study drug and had valid answers recorded for the WHQ domain for sleep problems.||Score on a scale||Standard Deviation|Mean
749289|NCT00535288|Secondary|Total Number of Remitters by Week|A participant was defined as a (hot flush) remitter for a study week if at most one moderate/severe vasomotor symptom per day on average was recorded. A study week was taken into account if at least 4 days were completely observed. The last observation was carried forward if there were less than 4 complete days observed. In cases where Week 1 did not have 4 days that were completely observed, the participant was considered a non-remitter.|Up to 12 weeks|The ITT population, defined as all randomized participants who had at least one pre-baseline and at least one post-baseline average of the number of hot flushes in a week. An LOCF approach was used.||Participants|||Number
749290|NCT00535288|Secondary|Total Number of Responders by Week|A participant was defined as a (hot flush) responder for a study week if a reduction of at least 50% for average daily frequency of moderate/severe vasomotor symptoms (hot flushes) (Frequency Score A) compared to Baseline was recorded. A study week was taken into account if at least 4 days were completely observed. The last observation was carried forward if there were less than 4 complete days observed. In cases where Week 1 did not have 4 days that were completely observed, the participant was considered a non-responder. An LOCF approach was used.|Up to 12 weeks|The ITT population, defined as all randomized participants who had at least one pre-baseline and at least one post-baseline average of the number of hot flushes in a week.||Participants|||Number
749291|NCT00535288|Secondary|Change From Baseline in Average Daily Mild to Severe Composite Symptoms Score (Composite Score B) by Week|Composite Score B was calculated as Severity Score B x Frequency Score B.|Baseline and up to Week 12|The ITT population, defined as all randomized participants who had at least one pre-baseline and at least one post-baseline average of the number of hot flushes in a week.||Composite score||Standard Deviation|Mean
749292|NCT00535288|Secondary|Change From Baseline in Average Daily Severity of Mild to Severe Vasomotor Symptoms (Severity Score B) by Week|Participants recorded the severity of hot flushes on a LogPad on a daily basis during screening and treatment. The severity of hot flushes was defined as: mild (sensation of heat without sweating); moderate (sensation of heat with sweating, able to continue activity); and severe (sensation of heat with sweating, causing cessation of activity). Severity Score B was calculated as the number of mild hot flushes + the number of moderate hot flushes x 2 + the number of severe hot flushes x 3, divided by the total number of all hot flushes per week. If no hot flushes were experienced, this was to be recorded as ‘no sensation of heat’. Baseline values were based on, at most, 7 completely observed pre-treatment days. If less than 4 days were completely observed during treatment, the averages of the previous week were carried forward (LOCF). If the number of days observed in Week 1 were not sufficient, baseline values were carried forward.|Baseline and up to Week 12|The ITT population, defined as all randomized participants who had at least one pre-baseline and at least one post-baseline average of the number of hot flushes in a week.||Severity score||Standard Deviation|Mean
749293|NCT00535288|Secondary|Change From Baseline in Average Daily Frequency of Mild to Severe Vasomotor Symptoms (Frequency Score B) by Week|Participants recorded the frequency (number) of vasomotor symptoms (hot flushes) on a LogPad on a daily basis during screening and treatment. Frequency Score B was based on the number of mild hot flushes + the number of moderate hot flushes + the number of severe hot flushes in one day. Baseline average was derived from, at most, 7 completely observed pre-treatment days. Weekly averages during treatment were calculated if at least 4 days with non-missing data were completely observed; if less than 4 days were completely observed, the averages of the previous week were carried forward (LOCF). If the number of days observed in Week 1 were not sufficient, baseline values were carried forward.|Baseline and up to Week 12|The ITT population, defined as all randomized participants who had at least one pre-baseline and at least one post-baseline average of the number of hot flushes in a week.||Events per day||Standard Deviation|Mean
749294|NCT00535288|Secondary|Change From Baseline in Average Daily Moderate/Severe Composite Score (Composite Score A) by Week|Composite Score A was calculated as Severity Score A x Frequency Score A.|Baseline and up to Week 12|The ITT population, defined as all randomized participants who had at least one pre-baseline and at least one post-baseline average of the number of hot flushes in a week.||Composite score||Standard Deviation|Mean
749295|NCT00535288|Primary|Change From Baseline in Average Daily Severity of Moderate/Severe Vasomotor Symptoms (Severity Score A) at Week 12|Participants recorded the severity of hot flushes on a LogPad on a daily basis during screening and treatment. The severity of hot flushes was defined as: mild (sensation of heat without sweating); moderate (sensation of heat with sweating, able to continue activity); and severe (sensation of heat with sweating, causing cessation of activity). Severity Score A was calculated as the number of moderate hot flushes x 2 + the number of severe hot flushes x 3, divided by the total number of moderate and severe hot flushes per week. If no hot flushes were experienced, this was to be recorded as ‘no sensation of heat’. Baseline values were based on, at most, 7 completely observed pre-treatment days. If less than 4 days were completely observed during treatment, the averages of the previous week were carried forward (LOCF). If the number of days observed in Week 1 were not sufficient, baseline values were carried forward.|Baseline and Week 12|The ITT population, defined as all randomized participants who had at least one pre-baseline and at least one post-baseline average of the number of hot flushes in a week.||Severity score||Standard Deviation|Mean
749305|NCT00535392|Secondary|Number of Subjects Who Received High-dose Levetiracetam Intravenous (LEV IV) (More Than 40 mg/kg/Day) During the Treatment Period (up to 4 Days)||Treatment period (up to 4 days)|All 33 subjects enrolled in the study were in the Intent to Treat (ITT) population and are included in this analysis.||Subjects|||Number
750474|NCT00553098|Secondary|Greater Than 50% CD33+ Donor Chimerisms at 1 Year Post Transplant|Number of patients who achieve greater than 50% CD33+ donor chimerisms at 1 year post transplant.|1 year|Excludes 9 patients who expired prior to 1 year time point||Participants|||Count of Participants
749296|NCT00535288|Secondary|Change From Baseline in Average Daily Severity of Moderate/Severe Vasomotor Symptoms (Severity Score A) by Week Excluding Weeks 4 and 12|Participants recorded the severity of hot flushes on a LogPad on a daily basis during screening and treatment. The severity of hot flushes was defined as: mild (sensation of heat without sweating); moderate (sensation of heat with sweating, able to continue activity); and severe (sensation of heat with sweating, causing cessation of activity). Severity Score A was calculated as the number of moderate hot flushes x 2 + the number of severe hot flushes x 3, divided by the total number of moderate and severe hot flushes per week. If no hot flushes were experienced, this was to be recorded as ‘no sensation of heat’. Baseline values were based on, at most, 7 completely observed pre-treatment days. If less than 4 days were completely observed during treatment, the averages of the previous week were carried forward (LOCF). If the number of days observed in Week 1 were not sufficient, baseline values were carried forward.|Baseline and up to Week 12|The ITT population, defined as all randomized participants who had at least one pre-baseline and at least one post-baseline average of the number of hot flushes in a week.||Severity score||Standard Deviation|Mean
749297|NCT00535288|Secondary|Change From Baseline in Average Daily Frequency of Moderate/Severe Vasomotor Symptoms (Frequency Score A) by Week Excluding Weeks 4 and 12|Participants recorded the frequency (number) of vasomotor symptoms (hot flushes) on a LogPad on a daily basis during screening and treatment. Frequency Score A was based on the number of moderate hot flushes + the number of severe hot flushes in one day. Baseline average was derived from, at most, 7 completely observed pre-treatment days. Weekly averages during treatment were calculated if at least 4 days with non-missing data were completely observed; if less than 4 days were completely observed, the averages of the previous week were carried forward (LOCF). If the number of days observed in Week 1 were not sufficient, baseline values were carried forward.|Baseline and Up to Week 12|The ITT population, defined as all randomized participants who had at least one pre-baseline and at least one post-baseline average of the number of hot flushes in a week.||Events per day||Standard Deviation|Mean
749298|NCT00535288|Primary|Change From Baseline in Average Daily Frequency of Moderate/Severe Vasomotor Symptoms (Frequency Score A) at Week 12|Participants recorded the frequency (number) of vasomotor symptoms (hot flushes) on a LogPad on a daily basis during screening and treatment. Frequency Score A was based on the number of moderate hot flushes + the number of severe hot flushes in one day. Baseline average was derived from, at most, 7 completely observed pre-treatment days. Weekly averages during treatment were calculated if at least 4 days with non-missing data were completely observed; if less than 4 days were completely observed, the averages of the previous week were carried forward (LOCF). If the number of days observed in Week 1 were not sufficient, baseline values were carried forward.|Baseline and Week 12|The ITT population, defined as all randomized participants who had at least one pre-baseline and at least one post-baseline average of the number of hot flushes in a week.||Events per day||Standard Deviation|Mean
749299|NCT00535288|Primary|Change From Baseline in Average Daily Severity of Moderate/Severe Vasomotor Symptoms (Severity Score A) at Week 4|Participants recorded the severity of hot flushes on a LogPad on a daily basis during screening and treatment. The severity of hot flushes was defined as: mild (sensation of heat without sweating); moderate (sensation of heat with sweating, able to continue activity); and severe (sensation of heat with sweating, causing cessation of activity). Severity Score A was calculated as the number of moderate hot flushes x 2 + the number of severe hot flushes x 3, divided by the total number of moderate and severe hot flushes per week. If no hot flushes were experienced, this was to be recorded as ‘no sensation of heat’. Baseline values were based on, at most, 7 completely observed pre-treatment days. If less than 4 days were completely observed during treatment, the averages of the previous week were carried forward (LOCF). If the number of days observed in Week 1 were not sufficient, baseline values were carried forward.|Baseline and Week 4|The ITT population, defined as all randomized participants who had at least one pre-baseline and at least one post-baseline average of the number of hot flushes in a week.||Severity score||Standard Deviation|Mean
749300|NCT00535288|Primary|Change From Baseline in Average Daily Frequency of Moderate/Severe Vasomotor Symptoms (Frequency Score A) at Week 4|Participants recorded the frequency (number) of vasomotor symptoms (hot flushes) on an electronic diary card (LogPad®) on a daily basis during screening and treatment. Frequency Score A was based on the number of moderate hot flushes + the number of severe hot flushes in one day. Baseline average was derived from, at most, 7 completely observed pre-treatment days. Weekly averages during treatment were calculated if at least 4 days with non-missing data were completely observed; if less than 4 days were completely observed, the averages of the previous week were carried forward (last observation carried forward, or LOCF). If the number of days observed in Week 1 were not sufficient, baseline values were carried forward.|Baseline and Week 4|The Intent-to-Treat (ITT) population, defined as all randomized participants who had at least one pre-baseline and at least one post-baseline average of the number of hot flushes in a week.||Events per day||Standard Deviation|Mean
749301|NCT00535301|Secondary|Vaginal Mesh Exposure|Vaginal mesh exposure defined as appearance of mesh, placed during the index surgery, not covered by overlying vaginal epithelium on postoperative pelvic exams subsequent to the first postoperative exam. May be either symptomatic or asymptomatic. This was not differentiated in the statistical analysis.|perioperative|||participants|||Number
749302|NCT00535301|Secondary|Operative Time|Calculated as time from first incision to time of closure of last incision.|perioperative|||minutes||Inter-Quartile Range|Median
749303|NCT00535301|Primary|Recurrent Stage II or Greater Anterior Vaginal Prolapse|Pelvic Organ Prolapse Quantification Point Ba is the most distal position of any part of the anterior vagina between point Aa and the vaginal cuff or anterior vaginal fornix. Better vaginal support is assigned a negative value (ie, if there is no prolapse, point Ba is –3 cm by definition). Vaginal prolapse beyond the hymen, indicating worse vaginal support, is assigned a positive value (this may be equal to the total vaginal length at the maximum). Recurrent stage II or greater anterior vaginal prolapse is defined as POPQ Point Ba measurement equal to or greater (more positive) than -1.|three years|Intention to Treat. Stage II or greater anterior vaginal prolapse was defined as POPQ Ba equal to or greater than -1.||participants|||Number
749304|NCT00535392|Secondary|Number of Consecutive Levetiracetam Intravenous (LEV IV) Doses Received||Treatment period (up to 4 days)|All 33 subjects enrolled in the study were in the Intent to Treat (ITT) population and are included in this analysis.||Consecutive doses||Standard Deviation|Mean
757458|NCT00608491|Secondary|Change in Blood Cystatin C||Baseline to Day 60|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mg/L||Standard Deviation|Mean
749307|NCT00535405|Secondary|Percentage of Patients With AVD Who Achieved LDL-C <70 mg/dL at Week 12|Patients with AVD Who Achieved LDL-C <70 mg/dL. AVD was defined as a history of myocardial infarction, stable angina, coronary artery procedures or evidence of clinically significant myocardial ischemia.|12 Weeks|Patients with AVD in the Full Analysis Set (FAS). The FAS population includes all randomized patients with baseline (BL) value and at least one valid after-BL value. After-BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent of Patients||Standard Error|Mean
749308|NCT00535405|Secondary|Percentage of Patients With High Risk for CHD Who Achieved LDL-C <70 mg/dL at Week 12|Risk was assessed utilizing a history of established CHD or CHD risk equivalent and Framingham Risk scoring.|12 Weeks|Patients with High Risk for CHD in the Full Analysis Set (FAS). The FAS population includes all randomized patients with baseline (BL) value and at least one valid after-BL value. After-BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent of Patients||Standard Error|Mean
749309|NCT00535405|Secondary|Percentage of Patients Who Achieved LDL-C <100 mg/dL at Week 12||12 Weeks|Full Analysis Set (FAS). The FAS population includes all randomized patients with baseline (BL) value and at least one valid after-BL value. After-BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent of Patients||Standard Error|Mean
749310|NCT00535405|Secondary|Percentage of Patients Without Atherosclerosis Vascular Disease (AVD) Who Achieved LDL-C <100 mg/dL or Patients With AVD Who Achieved LDL-C <70 mg/dL at Week 12|Patients with AVD Who Achieved LDL-C <70 mg/dL. AVD was defined as a history of myocardial infarction, stable angina, coronary artery procedures or evidence of clinically significant myocardial ischemia.|12 Weeks|Full Analysis Set (FAS). The FAS population includes all randomized patients with baseline (BL) value and at least one valid after-BL value. After-BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent of Patients||Standard Error|Mean
749311|NCT00535405|Secondary|Percentage of Patients Who Achieved LDL-C <70 mg/dL at Week 12||12 weeks|Full Analysis Set (FAS). The FAS population includes all randomized patients with baseline (BL) value and at least one valid after-BL value. After-BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent of Patients||Standard Error|Mean
749312|NCT00535405|Primary|Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 12||Baseline and 12 weeks|Full Analysis Set (FAS). The FAS population includes all randomized patients with baseline (BL) value and at least one valid after-BL value. After-BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent change in LDL-C||95% Confidence Interval|Least Squares Mean
749313|NCT00535496|Primary|Difference in Time Between Recovery of T4/T1 Ratio to 0.9 as Measured by TOF Watch® SX, and Reappearance of T4 as Measured by PNS, Within Participants, After Administration of 4.0 mg/kg Sugammadex|The difference between the recovery of T4/T1 ratio to 0.9 and reappearance of T4 within participants was assessed from an ANOVA method. Only participants treated with 4.0 mg/kg sugammadex are presented, where the TOF-Watch® SX on the dominant forearm n =30, and on the non-dominant forearm n = 31; and the PNS on the dominant forearm n =31, and on the non-dominant forearm n = 30. The 1.0 mg/kg sugammadex group was not evaluated for this outcome measure.|Up to 3 minutes after administering sugammadex|The ITT population: all randomized participants who received 4.0 mg/kg sugammadex, and had at least one efficacy measurement. As dominant and non-dominant forearms were aimed at preventing bias; their differences were not analyzed. One participant who did not reach a T4/T1 ratio of 0.9 was not analyzed. The 1.0 mg/kg group was not evaluated.||Minutes||95% Confidence Interval|Mean
749314|NCT00535496|Primary|Time From Start of Administration of 4.0 mg/kg Sugammadex to Reappearance of T4 Measured by a Peripheral Nerve Stimulator (PNS)|Neuromuscular function was monitored with a PNS by applying repetitive TOF stimulation to the ulnar nerve of one forearm every 15 seconds and assessing the number of twitches at the adductor pollicis muscle by a blinded PNS assessor. T4 is the fourth twitch after TOF nerve stimulation. Only participants treated with 4.0 mg/kg sugammadex are presented, where the PNS on the dominant forearm n =31, and on the non-dominant forearm n = 30. The 1.0 mg/kg sugammadex group was not evaluated for this outcome measure.|up to 2 minutes after administering sugammadex|The ITT population consisting of all randomized participants who received 4.0 mg/kg sugammadex, and had at least one efficacy measurement. As dominant and non-dominant forearms were aimed at preventing bias, their differences were not analyzed. Participants treated with 1.0 mg/kg were not evaluated for this outcome measure.||Minutes||Standard Deviation|Mean
749315|NCT00535496|Other Pre-specified|Time From Start of Administration of 1.0 or 4.0 mg/kg Sugammadex to Recovery of the T4/T1 Ratio to 0.7 Measured by a TOF-Watch® SX|Neuromuscular function was monitored by applying repetitive TOF electrical stimulations with the TOF-Watch® SX to the ulnar nerve of one forearm every 15 seconds & assessing twitch response at the adductor pollicis muscle with the TOF-Watch® SX. T1 and T4 are the magnitudes (heights) of the first and fourth twitches respectively after TOF nerve stimulation, where stimulation was continued until the T4/T1 ratio reached 0.7. A higher T4/T1 ratio indicates a lower degree of neuromuscular blockade, with a value of 1.0 representing full recovery. For participants treated with 1.0 mg/kg sugammadex the TOF-Watch® SX on the dominant forearm n =15, and on the non-dominant forearm n = 14. For participants treated with 4.0 mg/kg sugammadex the TOF-Watch® SX on the dominant forearm n =30, and on the non-dominant forearm n = 31.|Up to 42 minutes after administering sugammadex|The ITT population consisting of all randomized participants who received 1.0 or 4.0 mg/kg sugammadex, and had at least one efficacy measurement. As dominant and non-dominant forearms were aimed at preventing bias, their differences were not analyzed.||Minutes||Standard Deviation|Mean
749326|NCT00535730|Primary|Geometric Mean Titer (GMT) of the Pneumococcal Polysaccharide (PnPs) Serotype 22F Antibody Response at 4 Weeks Postvaccination.|GMT of the PnPs serotype 22F antibody response at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 and those who receive ZOSTAVAX™ and PNEUMOVAX™ 23 nonconcomitantly.|Four weeks postvaccination|Analysis was per protocol. The following protocol violations resulted in exclusion of subjects from analysis: prior receipt of a pneumococcal vaccine; receipt of prohibited medications; vaccine temperature compromised prior to administration; excluded medical condition; samples collected outside of Statistical Analysis Plan specified time window.||micrograms/mL||95% Confidence Interval|Geometric Mean
763682|NCT00670540|Secondary|Percentage of Participants Who Developed Venous Insufficiency (Leg Ulcer)||at 3 years|||percentage of participants||95% Confidence Interval|Number
749316|NCT00535496|Other Pre-specified|Time From Start of Administration of 1.0 or 4.0 mg/kg Sugammadex to Recovery of the T4/T1 Ratio to 0.8 Measured by a TOF-Watch® SX|Neuromuscular function was monitored by applying repetitive TOF electrical stimulations with the TOF-Watch® SX to the ulnar nerve of one forearm every 15 seconds & assessing twitch response at the adductor pollicis muscle with the TOF-Watch® SX. T1 and T4 are the magnitudes (heights) of the first and fourth twitches respectively after TOF nerve stimulation, where stimulation was continued until the T4/T1 ratio reached 0.8. A higher T4/T1 ratio indicates a lower degree of neuromuscular blockade, with a value of 1.0 representing full recovery. For participants treated with 1.0 mg/kg sugammadex the TOF-Watch® SX on the dominant forearm n =15, and on the non-dominant forearm n = 14. For participants treated with 4.0 mg/kg sugammadex the TOF-Watch® SX on the dominant forearm n =30, and on the non-dominant forearm n = 31.|Up to 42 minutes after administering sugammadex|The ITT population consisting of all randomized participants who received 1.0 or 4.0 mg/kg sugammadex, and had at least one efficacy measurement. As dominant and non-dominant forearms were aimed at preventing bias, their differences were not analyzed.||Minutes||Standard Deviation|Mean
749317|NCT00535496|Other Pre-specified|Time From Start of Administration of 1.0 mg/kg Sugammadex to Reappearance of T4 Measured by a PNS|Neuromuscular function was monitored by applying repetitive TOF stimulations manually to the ulnar nerve of one forearm every 15 seconds & the number of twitches collected manually at the adductor pollicis muscle with the PNS by a blinded PNS assessor. T4 is the fourth twitch after TOF nerve stimulation. Only participants treated with 1.0 mg/kg sugammadex are presented, where the PNS on the dominant forearm n =15, and on the non-dominant forearm n = 14. The 4.0 mg/kg sugammadex group was not evaluated for this outcome measure.|Up to 5 minutes after administering sugammadex|The ITT population consisting of all randomized participants who received 1.0 mg/kg sugammadex, and had at least one efficacy measurement. As dominant and non-dominant forearms were aimed at preventing bias, their differences were not analyzed. Participants treated with 4.0 mg/kg were not evaluated for this outcome measure.||Minutes||Standard Deviation|Mean
749318|NCT00535496|Other Pre-specified|Time From Start of Administration of 1.0 or 4.0 mg/kg Sugammadex to Reappearance of T4 Measured by a TOF-Watch® SX|Neuromuscular function was monitored by applying repetitive TOF electrical stimulations with the TOF-Watch® SX to the ulnar nerve of one forearm every 15 seconds & assessing twitch response at the adductor pollicis muscle with the TOF-Watch® SX. T4 is the fourth twitch after TOF nerve stimulation. For participants treated with 1.0 mg/kg sugammadex the TOF-Watch® SX on the dominant forearm n =15, and on the non-dominant forearm n = 14. For participants treated with 4.0 mg/kg sugammadex the TOF-Watch® SX on the dominant forearm n =30, and on the non-dominant forearm n = 31.|Up to 7 minutes after administering sugammadex|The ITT population consisting of all randomized participants who received 1.0 or 4.0 mg/kg sugammadex, and had at least one efficacy measurement. As dominant and non-dominant forearms were aimed at preventing bias, their differences were not analyzed.||Minutes||Standard Deviation|Mean
749319|NCT00535496|Other Pre-specified|Time From Start of Administration of 1.0 mg/kg Sugammadex to Recovery of the T4/T1 Ratio to 0.9 Measured by a TOF-Watch® SX|Neuromuscular function was monitored by applying repetitive TOF electrical stimulations with the TOF-Watch® SX to the ulnar nerve of one forearm every 15 seconds & assessing twitch response at the adductor pollicis muscle with the TOF-Watch® SX. T1 and T4 are the magnitudes (heights) of the first and fourth twitches respectively after TOF nerve stimulation, where stimulation was continued until the T4/T1 ratio reached 0.9. A higher T4/T1 ratio indicates a lower degree of neuromuscular blockade, with a value of 1.0 representing full recovery. Only participants treated with 1.0 mg/kg sugammadex are presented where the TOF-Watch® SX on the dominant forearm n =15, and on the non-dominant forearm n = 14. The 4.0 mg/kg sugammadex group was not evaluated for this outcome measure.|Up to 150 minutes after administering sugammadex|The ITT population: randomized participants who received 1.0 mg/kg sugammadex, and had at least one efficacy measurement. As dominant and non-dominant forearms were aimed at preventing bias, their differences were not analyzed. One participant was not analyzed as the time of recovery was judged unreliable. The 4.0 mg/kg group was not evaluated.||Minutes||Standard Deviation|Mean
749320|NCT00535496|Primary|Time From Start of Administration of 4.0 mg/kg Sugammadex to Recovery of the T4/T1 Ratio to 0.9 Measured by a TOF-Watch® SX|Neuromuscular function was monitored by applying repetitive TOF electrical stimulations with the TOF-Watch® SX to the ulnar nerve of one forearm every 15 seconds & assessing twitch response at the adductor pollicis muscle with the TOF-Watch® SX. T1 and T4 are the magnitudes (heights) of the first and fourth twitches respectively after TOF nerve stimulation, where stimulation was continued until the T4/T1 ratio reached 0.9. A higher T4/T1 ratio indicates a lower degree of neuromuscular blockade, with a value of 1.0 representing full recovery. Only participants treated with 4.0 mg/kg sugammadex are presented, where the TOF-Watch® SX on the dominant forearm n =30, and on the non-dominant forearm n = 31. The 1.0 mg/kg sugammadex group was not evaluated for this outcome measure.|Up to 4 minutes after administering sugammadex|The Intent-To-Treat (ITT) population: randomized, received 4.0 mg/kg sugammadex, and had at least one efficacy measurement. As dominant and non-dominant forearms were aimed at preventing bias, their differences were not analyzed. One participant who did not reach a T4/T1 ratio of 0.9 was not analyzed.The 1.0 mg/kg group was not evaluated.||Minutes||Standard Deviation|Mean
749321|NCT00535587|Secondary|Improvement of Fibromyalgia Symptoms||6 months||||||
749322|NCT00535587|Primary|Levels of Growth Hormone Post Exercise|Serum growth hormone at peak V02/treadmill|6 months|ITT||ng/ml||Standard Deviation|Mean
749323|NCT00535652|Primary|Tissue (Total) Concentrations of Ertapenem in the Colorectal Tissue|The mean (+- SD) tissuetotal concentrations of ertapenem in the colorectal tissue every 30 minutes up to 10 hours|The mean (+- SD) tissuetotal concentrations of ertapenem in the colorectal tissue as an average of every 30 miuntes up to 10 hours|||mg/kg||Standard Deviation|Mean
749324|NCT00535652|Secondary|Safety Assessment||0 to approx. 14 days after admission||||||
749325|NCT00535652|Primary|Concentration of Ertapenem in Colorectal Tissue in mg/kg 3 to 6 Hours After a Single Dose of 1 Gram Ertapenem I.V..||3 to 6 hours after a single dose of 1 gram ertapenem I.V..||||||
749348|NCT00535873|Primary|Overall Response Rate (ORR)|ORR defined as number of participants with best response of Complete or Partial response out of total number of participants. Response assessed using the NCI Working Group criteria for response following 3 cycles, 6 cycles and yearly thereafter.|From 3 cycles (90 days) up to 6 cycles (approximately 180 days)|||participants|||Number
757459|NCT00608491|Secondary|Change in Blood Uric Acid||Baseline to Day 60|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mg/dL||Standard Deviation|Mean
749327|NCT00535730|Primary|Geometric Mean Titer (GMT) of the Pneumococcal Polysaccharide (PnPs) Serotype 19A Antibody Response at 4 Weeks Postvaccination.|GMT of the PnPs serotype 19A antibody response at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 and those who receive ZOSTAVAX™ and PNEUMOVAX™ 23 nonconcomitantly.|Four weeks postvaccination|Analysis was per protocol. The following protocol violations resulted in exclusion of subjects from analysis: prior receipt of a pneumococcal vaccine; receipt of prohibited medications; vaccine temperature compromised prior to administration; excluded medical condition; samples collected outside of Statistical Analysis Plan specified time window.||micrograms/mL||95% Confidence Interval|Geometric Mean
749328|NCT00535730|Primary|Geometric Mean Titer (GMT) of the Pneumococcal Polysaccharide (PnPs) Serotype 14 Antibody Response at 4 Weeks Postvaccination.|GMT of the PnPs serotype 14 antibody response at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 and those who receive ZOSTAVAX™ and PNEUMOVAX™ 23 nonconcomitantly.|Four weeks postvaccination|Analysis was per protocol. The following protocol violations resulted in exclusion of subjects from analysis: prior receipt of a pneumococcal vaccine; receipt of prohibited medications; vaccine temperature compromised prior to administration; excluded medical condition; samples collected outside of Statistical Analysis Plan specified time window.||micrograms/mL||95% Confidence Interval|Geometric Mean
749329|NCT00535730|Primary|Geometric Mean Titer (GMT) of the Pneumococcal Polysaccharide (PnPs) Serotype 3 Antibody Response at 4 Weeks Postvaccination.|GMT of the PnPs serotype 3 antibody response at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 and those who receive ZOSTAVAX™ and PNEUMOVAX™ 23 nonconcomitantly.|Four weeks postvaccination|Analysis was per protocol. The following protocol violations resulted in exclusion of subjects from analysis: prior receipt of a pneumococcal vaccine; receipt of prohibited medications; vaccine temperature compromised prior to administration; excluded medical condition; samples collected outside of Statistical Analysis Plan specified time window.||micrograms/mL||95% Confidence Interval|Geometric Mean
749330|NCT00535730|Primary|Geometric Mean Fold Rise (GMFR) of the Varicella-zoster Virus (VZV) Antibody Responses From Day 1 to 4 Weeks Postvaccination.|"GMFR of the VZV antibody response from prevaccination to Week 4 postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23.
gpELISA = glycoprotein enzyme-linked immunosorbent assay."|Four weeks postvaccination|Analysis was per protocol. The following protocol violations resulted in exclusion of subjects from analysis: receipt of prohibited medications; vaccine temperature compromised prior to administration; excluded medical condition; samples collected outside of Statistical Analysis Plan specified time window; exposure to herpes zoster (HZ) or VZV.||gpELISA units/mL||95% Confidence Interval|Geometric Mean
749331|NCT00535730|Secondary|Safety and Tolerability of Both Vaccines When Administered Concomitantly.|All adverse events were analyzed including serious adverse events; injection-site adverse events; Vaccination Report Card prompted systemic adverse events, including varicella-like rashes or herpes zoster-like rashes; all other systemic adverse events.|Eight weeks postvaccination|All subjects who received at least one vaccination||Participants|||Number
749332|NCT00535730|Primary|Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination|"GMT of the VZV antibody responses at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 and those who receive ZOSTAVAX™ and PNEUMOVAX™ 23 nonconcomitantly.
*gpELISA = glycoprotein enzyme-linked immunosorbent assay"|4 weeks postvaccination|Analysis was per protocol. The following protocol violations resulted in exclusion of subjects from analysis: receipt of prohibited medications; vaccine temperature compromised prior to administration; excluded medical condition; samples collected outside of Statistical Analysis Plan specified time window; exposure to herpes zoster (HZ) or VZV.||gpELISA units*/mL||95% Confidence Interval|Geometric Mean
749333|NCT00535769|Secondary|Recalled Frequency of Sunscreen Application|The participants were asked to recall their frequency of sunscreen application based on a 5 point scale (0 never used sunscreen,; 1 forgot to apply 3x weekly,; 2 forgot to apply 1-2x weekly; 3 forgot to apply 1-2x per month; 4 always remembered)|6 weeks|All participants were assessed||units on a scale||Standard Deviation|Mean
749334|NCT00535769|Secondary|Usefulness of Text Messaging System|Patients with the text message reminder system were asked their opinion on their satisfaction/ improved adherence to sunscreen application with the use of the messaging system on a scale of 0 to 10 (0, not useful at all; 10,most useful)|6 weeks|Patients with text messaging system included in analysis||units on a scale||Standard Deviation|Mean
749335|NCT00535769|Primary|Number of Days the Subjects Are Adherent to Using Sunscreen|Participants’ adherence was captured in real time using transmitting electronic monitors. At the end of the 6 week trial, the mean number of days the subjects are adherent to using sunscreen were compared.|6 weeks|All participants were analyzed||days||95% Confidence Interval|Mean
749336|NCT00535782|Primary|Change From Baseline to Week 12 in Aortic Pulse Wave Velocity (PWV)|Aortic (central) arterial stiffness was assessed with Pulse Wave Analysis (PWA) of the radial artery and carotid-femoral PWV using applanation tonometry after the patient had rested in a supine position for at least 10 minutes.|Baseline and Week 12|Intent to treat (ITT) population. All randomized patients who received any part of an infusion of study medication are included. Patients who received an incorrect therapy from that intended are summarized in the group according to the intended randomized treatment group. Last observation carried forward (LOCF) imputation was used.||meters/second||Standard Deviation|Mean
749337|NCT00535782|Secondary|Number of Participants Experiencing Adverse Events (AEs)|"A severe AE is an event in which the intensity of the event results in an inability to work or perform normal daily activity.
A Serious AE is fatal, life-threatening, requires in-patient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant or requires intervention to prevent one of the above outcomes.
AEs of special interest include infection, gastrointestinal, infusion reaction (occurring during or within 24 hours of infusion), hepatic disorder, myocardial infarction and stroke."|Up to Week 24|The safety population includes all patients who received any part of an infusion of study drug and who provided at least one assessment of safety. Randomized patients who received the incorrect therapy from that intended are summarized in the group according to the therapy actually received.||participants|||Number
749365|NCT00536107|Primary|Number of Patients With Serious Adverse Events (SAEs)||From time consent was given to 28 days after last dose|||participants|||Number
763683|NCT00670540|Secondary|Percentage of Participants Who Developed Cancer Onset||at 3 years|||percentage of participants||95% Confidence Interval|Number
749338|NCT00535782|Secondary|Change From Baseline to Week 24 in Aortic Pulse Wave Velocity (PWV)|Aortic (central) arterial stiffness was assessed with Pulse Wave Analysis (PWA) of the radial artery and carotid–femoral PWV using applanation tonometry after the patient had rested in a supine position for at least 10 minutes.|Baseline and Week 24|Intent to treat (ITT) population. All randomized patients who received any part of an infusion of study medication are included. Patients who received an incorrect therapy from that intended are summarized in the group according to the intended randomized treatment group. Last observation carried forward (LOCF) imputation was used.||meters/second||Standard Deviation|Mean
749339|NCT00535782|Secondary|Change From Baseline to Week 24 in Small Low Density Lipoprotein (sLDL) Particle Numbers|Small LDL particles are associated with an increased risk of cardiovascular disease: more of these small particles lead to a greater risk. The concentration of fasting small LDL particles was determined using the Nuclear Magnetic Resonance (NMR) methodology.|Baseline and Week 24|Intent to treat (ITT) population. All randomized patients who received any part of an infusion of study medication are included. Patients who received an incorrect therapy from that intended are summarized in the group according to the intended randomized treatment group. Last observation carried forward (LOCF) imputation was used.||nmol/L||Standard Deviation|Mean
749340|NCT00535782|Primary|Change From Baseline in Small Low Density Lipoprotein (sLDL) Particle Numbers|Small LDL particles are associated with an increased risk of cardiovascular disease: more of these small particles lead to a greater risk. The concentration of fasting small LDL particles was determined using the Nuclear Magnetic Resonance (NMR) methodology.|Baseline and Week 12|Intent to treat (ITT) population. All randomized patients who received any part of an infusion of study medication are included. Patients who received an incorrect therapy from that intended are summarized in the group according to the intended randomized treatment group. Last observation carried forward (LOCF) imputation was used.||nmol/L||Standard Deviation|Mean
749341|NCT00535821|Primary|Mortality|In-hospital mortality|hospital|||participants|||Number
749342|NCT00535847|Primary|Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)|"AE: any adverse change from the subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Study drug includes all investigational agents (including placebo, if applicable) administered during the course of the study."|Baseline through Week 48|The FA set included all enrolled subjects who received at least 1 dose of study drug in this study (VX06-950-107 [NCT00535847]).||participants|||Number
749343|NCT00535847|Secondary|Cross Tabulation of Extended Rapid Viral Response (eRVR) and Sustained Viral Response (SVR) in With Prior Response|Cross tabulation of number of subjects with eRVR/SVR status in present study was presented with respect to prior response status of subjects in parent studies. eRVR=undetectable HCV RNA at Week 4 and Week 12, SVR=undetectable HCV RNA at end of treatment (EOT) and at 24 weeks after last dose of study treatment without any confirmed detectable HCV RNA in between. Prior response=subjects were categorized into following categories based on their viral response in the parent study: Null Response (less than [<] 1-log10 decrease in HCV RNA at Week 4 or <2-log10 decrease in HCV RNA at Week 12), Partial Response (greater than [>] 2-log10 decrease in HCV RNA at Week 12, but detectable HCV RNA at Week 24), Viral Breakthrough (detectable HCV RNA during treatment after achieving undetectable HCV RNA), Relapse (undetectable HCV RNA at EOT but detectable HCV RNA during viral follow-up). Plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay; lower limit of detection=10 IU/mL.|Baseline up to Week 72|The FA set included subjects who received at least 1 dose of study drug in this study (VX06-950-107 [NCT00535847]). Data was presented for overall subjects based on eRVR and SVR status as per planned analysis.||participants|||Number
749344|NCT00535847|Secondary|Percentage of Subjects With Undetectable HCV RNA at Week 48 After Completion of Treatment Among Subjects Who Completed Assigned Treatment|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).|48 weeks after completion of treatment (up to Week 96)|Analysis population included subjects who completed assigned treatment in this study (VX06-950-107 [NCT00535847]).||percentage of participants||95% Confidence Interval|Number
749345|NCT00535847|Secondary|Percentage of Subjects With End of Treatment Response|Subjects were considered to have an end of treatment response if they completed the assigned treatment regimen and had undetectable HCV RNA at end of treatment or prematurely discontinued the assigned treatment regimen and had undetectable HCV RNA at the time of discontinuation. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).|End of treatment (up to Week 48)|The FA set included all enrolled subjects who received at least 1 dose of study drug in this study (VX06-950-107 [NCT00535847]).||percentage of participants||95% Confidence Interval|Number
749346|NCT00535847|Secondary|Percentage of Prior Relapsers With Undetectable HCV RNA|Prior relapsers: subjects who had undetectable HCV RNA at the end of treatment in parent study but reverted to detectable levels of HCV RNA after stopping treatment in parent study were categorized as prior relapsers. Percentage of prior relapsers with undetectable HCV RNA 24 weeks after the completion of treatment in this study were presented. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).|24 weeks after the completion of treatment (up to Week 72)|Analysis population included all enrolled subjects who were prior relapsers in parent study (VX05-950-104 [NCT00336479], VX05-950-104EU [NCT00372385] or VX06-950-106 [NCT00420784]) and received at least 1 dose of study drug in this study (VX06-950-107 [NCT00535847]).||percentage of participants||95% Confidence Interval|Number
749347|NCT00535847|Primary|Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Treatment|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).|24 weeks after the completion of treatment (up to Week 72)|The FA set included all enrolled subjects who received at least 1 dose of study drug in this study (VX06-950-107 [NCT00535847]).||percentage of participants||95% Confidence Interval|Number
749349|NCT00535938|Secondary|Concurrent Surgical Procedure Resource Utilization Patterns|Resource utilization patterns are assessed in terms of concurrent surgical procedures utilized during the study (up to 1,785 days across all indications) and are grouped by highest level term. (Note: NEC=not elsewhere classified)|Up to 1,785 days|Enrolled Cohort: All patients enrolled in the study||Patients|||Number
749350|NCT00535938|Secondary|Concurrent Procedure Resource Utilization Patterns|Resource utilization patterns are assessed in terms of concurrent procedures utilized during the study (up to 1,785 days across all indications) and are grouped by highest level term. (Note: NEC=not elsewhere classified)|Up to 1,785 days|Enrolled Cohort: All patients enrolled in the study||Patients|||Number
749351|NCT00535938|Secondary|"BOTOX® Dose in Patients With Other Disorders"|"Other disorders include focal dystonia (involuntary muscular contractions/abnormal postures), headache, pain, tics (sudden, repetitive, nonrhythmic movements/vocalizations), tremors (unintentional, rhythmic muscle movements), and other nonspecified disorders. The BOTOX® dose was assessed in this patient population. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician’s discretion and was a maximum of 568 days for patients with other disorders."|Baseline, SV1 (up to 568 days)|Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point||Units||Standard Deviation|Mean
749352|NCT00535938|Secondary|BOTOX® Dose in Patients With Facial Nerve Disorder|Facial nerve disorder is a condition causing twitching, weakness or paralysis of the face. The BOTOX® dose was assessed in this patient population. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician’s discretion and was a maximum of 765 days for patients with facial nerve disorder.|Baseline, SV1 (up to 765 days)|Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point||Units||Standard Deviation|Mean
749353|NCT00535938|Secondary|BOTOX® Dose in Patients With Cerebral Palsy|Cerebral Palsy is a disability resulting in muscular incoordination and speech disturbances. The BOTOX® dose was assessed in this patient population. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician’s discretion and was a maximum of 925 days for patients with cerebral palsy.|Baseline, SV1 (up to 925 days)|Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point||Units||Standard Deviation|Mean
749354|NCT00535938|Secondary|BOTOX® Dose in Patients With Adult Focal Spasticity|Adult Focal Spasticity is a condition in which muscles are continuously tight or stiff in a certain area. The BOTOX® dose was assessed in this patient population. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician’s discretion and was a maximum of 1,562 days for patients with adult focal spasticity.|Baseline, SV1 (up to 1,562 days)|Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point||Units||Standard Deviation|Mean
749355|NCT00535938|Secondary|BOTOX® Dose in Patients With Hyperhidrosis|Hyperhidrosis is a condition causing excessive sweating, regardless of temperature or exercise. The BOTOX® dose was assessed in this patient population. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician’s discretion and was a maximum of 1,273 days for patients with hyperhidrosis.|Baseline, SV1 (up to 1,273 days)|Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point||Units||Standard Deviation|Mean
749356|NCT00535938|Secondary|BOTOX® Dose in Patients With Blepharospasm|Blepharospasm is a condition in which the eyelids blink/close involuntarily. The BOTOX® dose was assessed in this patient population. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician’s discretion and was a maximum of 542 days for patients with blepharospasm.|Baseline, SV1 (up to 542 days)|Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point||Units||Standard Deviation|Mean
749357|NCT00535938|Secondary|BOTOX® Dose in Patients With Cervical Dystonia|Cervical dystonia is a condition in which the neck muscles contract involuntarily, causing the head to turn to one side, forward or backward. The BOTOX® dose was assessed in this patient population. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician’s discretion and was a maximum of 505 days for patients with cervical dystonia.|Baseline, SV1 (up to 505 days)|Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point||Units||Standard Deviation|Mean
749358|NCT00535938|Primary|"Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Other Disorders"|"Other disorders include focal dystonia (involuntary muscular contractions/abnormal postures), headache, pain, tics (sudden, repetitive, nonrhythmic movements/vocalizations), tremors (unintentional, rhythmic muscle movements), and other nonspecified disorders. The SF-12 is 12 questions on various health questions. Health utility is a numerical indicator of a person’s preference for a given health state or health outcome. Health utility is a sub-score ranging from 0(death) to 1(perfect health) calculated from the SF-12 total score based on: physical functioning, role participation, social functioning, bodily pain, mental health, and vitality and is termed SF-6D. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. The length of time between Baseline and SV1 is scheduled at the physician’s discretion and was a maximum of 568 days for patients with other disorders."|Baseline, SV1 (up to 568 days)|Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point||Scores on a Scale||Standard Deviation|Mean
749366|NCT00536107|Primary|Number of Patients With Adverse Event (AE)||From time consent was given to 28 days after last dose of study drug.|Evaluable for Safety population: All patients who recived at least one dose of study drug||Participants|||Number
749510|NCT00543803|Secondary|Investigator's Global Clinical Assessment of Patient General Health Status|Investigators opinion of patients general health condition at baseline versus last evaluation on treatment|from baseline to last value on treatment in between 36 months|FAS- All patients were considered for the full analysis set.||participants|||Number
749359|NCT00535938|Primary|Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Facial Nerve Disorder|Facial nerve disorder is a condition causing twitching, weakness or paralysis of the face. The SF-12 consists of 12 questions on various health questions. Health utility is a numerical indicator of a person’s preferences for a given health state or health outcome. Health utility is a sub-score ranging from 0 (death) to 1 (perfect health) and is calculated from the SF-12 total score based on the following items: physical functioning, role participation, social functioning, bodily pain, mental health, and vitality and is termed SF-6D. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician’s discretion and was a maximum of 765 days for patients with facial nerve disorder.|Baseline, SV1 (up to 765 days)|Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point||Scores on a Scale||Standard Deviation|Mean
749360|NCT00535938|Primary|Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Adult Focal Spasticity|Adult Focal Spasticity is a condition in which muscles are continuously tight or stiff in a certain area. The SF-12 consists of 12 questions on various health questions. Health utility is a numerical indicator of a person’s preferences for a given health state or health outcome. Health utility is a sub-score ranging from 0 (death) to 1 (perfect health) and is calculated from the SF-12 total score based on the following items: physical functioning, role participation, social functioning, bodily pain, mental health, and vitality and is termed SF-6D. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician’s discretion and was a maximum of 1,562 days for patients with adult focal spasticity.|Baseline, SV1 (up to 1,562 days)|Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point||Scores on a Scale||Standard Deviation|Mean
749361|NCT00535938|Primary|Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Cerebral Palsy|Cerebral Palsy is a disability resulting in muscular incoordination and speech disturbances. The SF-12 consists of 12 questions on various health questions. Health utility is a numerical indicator of a person’s preferences for a given health state or health outcome. Health utility is a sub-score ranging from 0 (death) to 1 (perfect health) and is calculated from the SF-12 total score based on the following items: physical functioning, role participation, social functioning, bodily pain, mental health, and vitality and is termed SF-6D. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician’s discretion and was a maximum of 925 days for patients with cerebral palsy.|Baseline, SV1 (up to 925 days)|Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point||Scores on a Scale||Standard Deviation|Mean
749362|NCT00535938|Primary|Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Hyperhidrosis|Hyperhidrosis is a condition causing excessive sweating, regardless of temperature or exercise. The SF-12 consists of 12 questions on various health questions. Health utility is a numerical indicator of a person’s preferences for a given health state or health outcome. Health utility is a sub-score ranging from 0 (death) to 1 (perfect health) and is calculated from the SF-12 total score based on the following items: physical functioning, role participation, social functioning, bodily pain, mental health, and vitality and is termed SF-6D. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician’s discretion and was a maximum of 1,273 days for patients with hyperhidrosis.|Baseline, SV1 (up to 1,273 days)|Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point||Scores on a Scale||Standard Deviation|Mean
749363|NCT00535938|Primary|Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Blepharospasm|Blepharospasm is a condition in which the eyelids blink/close involuntarily. The SF-12 consists of 12 questions on various health questions. Health utility is a numerical indicator of a person’s preferences for a given health state or health outcome. Health utility is a sub-score ranging from 0 (death) to 1 (perfect health) and is calculated from the SF-12 total score based on the following items: physical functioning, role participation, social functioning, bodily pain, mental health, and vitality and is termed SF-6D. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician’s discretion and was a maximum of 542 days for patients with blepharospasm.|Baseline, SV1 (up to 542 days)|Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point||Scores on a Scale||Standard Deviation|Mean
749364|NCT00535938|Primary|Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Cervical Dystonia|Cervical dystonia is a condition in which the neck muscles contract involuntarily, causing the head to turn to one side, forward or backward. The SF-12 consists of 12 questions on various health questions. Health utility is a numerical indicator of a person’s preferences for a given health state or health outcome. Health utility is a sub-score ranging from 0 (death) to 1 (perfect health) and is calculated from the SF-12 total score based on the following items: physical functioning, role participation, social functioning, bodily pain, mental health, and vitality and is termed SF-6D. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician’s discretion and was a maximum of 505 days for patients with cervical dystonia.|Baseline, SV1 (up to 505 days)|Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point||Scores on a Scale||Standard Deviation|Mean
749367|NCT00536120|Secondary|Mean Alpha4-Integrin Expression at Baseline, Month 3, and Month 6|Alpha4-integrin expression is the mean fluorescent intensity (MFI), a measure of fluorescence intensity often used to monitor changes in surface antigen modulation in flow cytometry. There is no reference range for this test, which was developed at Biogen Idec.|Month 0 (Baseline), Month 3, and Month 6|Participants who had received at least 1 dose of Tysabri and had at least 1 post-baseline assessment. n=number of participants with measurement at given timepoint.||mean fluorescent intensity (MFI)||Standard Deviation|Mean
749368|NCT00536120|Secondary|Mean Alpha4-Integrin Saturation at Baseline, Month 3, and Month 6|Measurement of the degree of natalizumab saturation of the alpha4 integrin on peripheral blood mononuclear cells was accomplished by staining cells with phycoerythrin conjugated anti human IgG4 antibody (hIgG4-PE) to label the cell-bound natalizumab, followed by flow cytometric detection and quantification.|Month 0 (Baseline), Month 3, and Month 6|Participants who received at least 1 dose of Tysabri and had at least 1 post-baseline assessment. n=number of participants with measurement at given timepoint.||percent saturation||Standard Deviation|Mean
749369|NCT00536120|Secondary|Mean Percentage Change From Baseline in Circulating Lymphocyte Subsets CD3+, CD4+, CD8+, CD19+, and CD56+ at Month 6 of Tysabri Therapy|The effect of Tysabri on circulating lymphocyte subsets (CD3+, CD4+, CD8+, CD19+, and CD56+) was calculated as a percentage change from baseline pre-treatment values (based on absolute count).|Month 0 (Baseline), Month 6|Participants who had received at least 3 doses of Tysabri per protocol; those with insufficient Tysabri dosing or protocol violations were excluded from the relevant analysis population.||percent change||Standard Deviation|Mean
749370|NCT00536120|Secondary|Mean Percentage Change From Baseline in Circulating Lymphocyte Subsets CD3+, CD4+, CD8+, CD19+, and CD56+ at Month 3 of Tysabri Therapy|The effect of Tysabri on circulating lymphocyte subsets (CD3+, CD4+, CD8+, CD19+, and CD56+) was calculated as a percentage change from baseline pre-treatment values (based on absolute count).|Month 0 (Baseline), Month 3|Participants who had received at least 3 doses of Tysabri per protocol; those with insufficient Tysabri dosing or protocol violations were excluded from the relevant analysis population.||percent change||Standard Deviation|Mean
749371|NCT00536120|Primary|Percentage of Tetanus Diphtheria Toxoid (Td) Responders at Day 28 Post-Vaccination|Tetanus responders were defined as participants who had at least a 2-fold increase over pre-immunization levels of anti-tetanus antibodies in their blood at 28 days after they were immunized with tetanus.|28 days after immunization (Day 28 for Vaccinations Only Group/Day 196 for Tysabri Plus Vaccinations Group)|Participants with an assessment at Day 28 and a pre-immunization antibody value ≤ 3.5 IU/mL. No imputation methods were used in the primary analyses.||percentage of participants|||Number
749372|NCT00536120|Primary|Percentage of Keyhole Limpet Hemocyanin (KLH) Responders at Day 28 Post-Vaccination|KLH responders were defined as those participants who had at least a 2-fold increase over pre-immunization level of anti-KLH antibodies in their blood at 28 days after vaccination with KLH.|28 days after immunization (Day 28 for Vaccinations Only Group/Day 196 for Tysabri Plus Vaccinations Group)|Participants with an assessment at Day 28. No imputation methods were used in the primary analyses.||percentage of participants|||Number
749373|NCT00536172|Secondary|Depressive Symptoms as Assessed by the Quick Inventory of Depressive Symptomatology-Clinician Rated 16 (QIDS-C-16)|Clinician-rated measure of a patient's depressive symptoms|Measured pre-treatment and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, and 28||||||
749374|NCT00536172|Primary|Depression as Assessed by the Quick Inventory of Depressive Symptomatology-Self Rated 16 (QIDS-SR-16)|Number of participants reaching pre-defined threshold on the QIDS-SR-16 of >/=11. The QIDS-SR-16 total score ranges from 0-27. Scores ranging from 0 to 10 correspond with no to mild depression, while scores >/= 11 correspond to moderate to severe depression.|Measured pre-treatment and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, and 28|Evaluable subjects||participants|||Number
749375|NCT00536198|Secondary|Clinical Global Impressions-Improvement (CGI-I)|The Clinical Global Impressions-Improvement (CGI-I) scale is a 7-point scale with 7 being the least improvement.|Cycle 1 to Cycle 6|all participants who were measured at a visit past baseline were analyzed||units on a scale||Standard Deviation|Mean
749376|NCT00536198|Secondary|DRSP Anger/Irritability Subscale|Anger/irritability included anger/irritability and conflicts with people. Symptoms were scored on a scale 1-6. The range is 0 to 12 with a higher score indicating greater symptom severity.|Baseline to Cycle 6|||units on a scale||Standard Deviation|Mean
749377|NCT00536198|Secondary|DRSP Physical Subscale|Physical symptoms included breast tenderness, bloating, headache, joint or muscle pain. Symptoms were scored on a scale of 1-6. The severity range is 0-24 with 24 being more symptomatic.|Baseline to Cycle 6|||units on a scale||Standard Deviation|Mean
749378|NCT00536198|Secondary|DRSP Depression Subscale|Depressive symptoms included: felt depressed, felt hopeless, felt worthless or guilt, slept more, trouble sleeping, felt overwhelmed. Symptoms were scored on a scale of 1-6 The score range is 0-36 with higher indicating greater severity.|Baseline to Cycle 6|||units on a scale||Standard Deviation|Mean
749379|NCT00536198|Primary|DRSP|DRSP (Daily Rating of Severity Problems) is composed of 21 items reflecting the 11 candidate symptoms for PMDD according to DSM IV and DSM V. Each symptom is scored 1-6. A diagnosis of PMDD requires a minimum average luteal phase score of greater than or equal to 3 (mild) for at least 5 PMDD symptoms during the five most symptomatic of the final seven luteal phase days and the first two days of menses onset, and we require that the average follicular phase score not be >2 on these same items. The minimum score is 0 and maximum is 126 for the total score. A higher score indicates greater severity of symptoms.|Baseline to Cycle 6|||units on a scale||Standard Deviation|Mean
749380|NCT00536198|Primary|Number of Symptomatic Days Before Pills Were Taken|"Symptomatic days were those that participant experienced at least 3 symptoms at a severity of at least 3, which is a mean of at least mild."|Cycle 1 to Cycle 6|all enrolled participants were analyzed||days||Standard Deviation|Mean
749381|NCT00536198|Primary|Number of Days Pills Were Taken|The number of days that pills were taken on.|Measured from Cycle 1 to Cycle 6|all participants enrolled were analyzed||number of days||Standard Deviation|Mean
749382|NCT00536198|Other Pre-specified|Adverse Events|A measurement of frequency of adverse events by random assignment|Baseline through Cycle 6|all enrolled participants were analyzed||participants|||Number
749383|NCT00536198|Secondary|Clinical Global Severity (CGI-S)|Clinical Global Impressions-Severity is measured on a scale of 1-7, with 7 as most severe.|Baseline through Cycle 6|all participants enrolled analyzed||units on a scale||Standard Deviation|Mean
749384|NCT00536198|Primary|Michelson SSRI Withdrawal Checklist|Michelson SSRI Withdrawal Checklist - 16-item (not exactly 17-item, mood swings and crying were in DRSP) including dizziness, nausea, unusual dreams, chills, increased sweating, loose stools, agitation, ringing or noises in the ears. Items were summed for 3 days after pill-taking ended for each menstrual cycle.Scale is 0-80 for total range of the scale with lower less severe. There are no units|Measured from Cycle 1 to Cycle 6|all participants enrolled were analyzed||units on a scale||Standard Deviation|Mean
749385|NCT00536198|Primary|Inventory of Depression Symptoms (IDS-C)|Inventory of Depressive Symptomatology-Clinician version (IDS-C) - a depression measure that has 28 items and detects appropriate variations between follicular and luteal phases in subjects with PMDD. Min score is 0, max is 84.Lower score is less symptomatic.|Measured from baseline to Cycle 6|all participants enrolled were analyzed||units on a scale||Standard Deviation|Mean
749386|NCT00536198|Primary|Premenstrual Tension Scale (PMTS)|The PMTS is a 10-item scale constructed to study premenstrual syndromes. It is sensitive to change with treatment. It includes items of irritability-hostility, tension, efficiency, dysphoria, motor coordination, mental-cognitive functioning, eating habits, social impairment, sex drive, and physical symptoms. PMTS-O or PMTS-SR? Min=0 (asymptomatic), Max=40 (Highly symptomatic), higher scores indicate most severe problems|Measured from baseline to Cycle 6|all randomized participants||units on a scale||Standard Deviation|Mean
749387|NCT00542269|Secondary|Percentage of Patients Who Developed Diabetes at End of Study|A patient had diabetes if fasting plasma glucose > 7 mmol/L.|Week 12|Intent-to-treat (ITT) population: All patients that received at least 1 dose of study drug and had baseline and at least 1 post-baseline assessment of the primary efficacy variable.||Percentage of patients|||Number
749388|NCT00542269|Secondary|Change in HbA1c (Glycated Hemoglobin) From Baseline to End of Study - Aliskiren/Amlodipine vs Ramipril/Amlodipine)||Baseline to Week 12|Intent-to-treat (ITT) population. All patients that received at least 1 dose of study drug and had baseline and at least 1 post-baseline assessment of the variable.||mmol/mol||Standard Error|Least Squares Mean
749389|NCT00542269|Secondary|Change in HbA1c (Glycated Hemoglobin) From Baseline to End of Study - Aliskiren/Ramipril/Amlodipine vs Ramipril/Amlodipine||Baseline to Week 12|Intent-to-treat (ITT) population. All patients that received at least 1 dose of study drug and had baseline and at least 1 post-baseline assessment of the variable.||mmol/mol||Standard Error|Least Squares Mean
749390|NCT00542269|Secondary|Change in HOMA-β From Baseline to End of Study|Homeostasis model assessment-β (HOMA-β) was defined as fasting insulin (μU/mL) x 20 / (fasting glucose (mmol/L) - 3.5).|Baseline to Week 12|Intent-to-treat (ITT) population. All patients that received at least 1 dose of study drug and had baseline and at least 1 post-baseline assessment of the variable.||mmol/L||Standard Deviation|Mean
749391|NCT00542269|Secondary|Change in HOMA-IR From Baseline to End of Study|Homeostasis model assessment-insulin resistance (HOMA-IR) was defined as (fasting insulin [μU/mL] x fasting glucose [mmol/L]) / 22.5.|Baseline to Week 12|Intent-to-treat (ITT) population. All patients that received at least 1 dose of study drug and had baseline and at least 1 post-baseline assessment of the variable.||mmol/L||Standard Deviation|Mean
749392|NCT00542269|Secondary|Percentage of Patients Who Achieved Normalized Blood Pressure at End of Study|Normalized was defined as a msSBP < 140 mmHg and/or a msDBP < 90 mmHg.|Week 12|Intent-to-treat (ITT) population. All patients that received at least 1 dose of study drug and had baseline and at least 1 post-baseline assessment of the variable.||Percentage of patients|||Number
749393|NCT00542269|Secondary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study - Aliskiren/Amlodipine vs Ramipril/Amlodipine|Automated blood pressure determinations were made with the Omron HEM-705CP blood pressure monitor at trough (24 hours ± 3 hours post-dose) and recorded at all study visits following detailed directions specified in the study protocol. Three readings were made and msDBP was calculated as the average of the 3 readings. In the event of aberrant readings, ie, the lowest reading was ≥ 10 mmHg systolic or ≥ 5 mmHg diastolic lower than the highest of the 3 readings, 3 additional readings were obtained. A negative change indicates improvement.|Baseline to Week 12|Intent-to-treat (ITT) population. All patients that received at least 1 dose of study drug and had baseline and at least 1 post-baseline assessment of the variable.||mmHg||Standard Error|Least Squares Mean
749394|NCT00542269|Secondary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study - Aliskiren/Ramipril/Amlodipine vs Ramipril/Amlodipine|Automated blood pressure determinations were made with the Omron HEM-705CP blood pressure monitor at trough (24 hours ± 3 hours post-dose) and recorded at all study visits following detailed directions specified in the study protocol. Three readings were made and msDBP was calculated as the average of the 3 readings. In the event of aberrant readings, ie, the lowest reading was ≥ 10 mmHg systolic or ≥ 5 mmHg diastolic lower than the highest of the 3 readings, 3 additional readings were obtained. A negative change indicates improvement.|Baseline to Week 12|Intent-to-treat (ITT) population. All patients that received at least 1 dose of study drug and had baseline and at least 1 post-baseline assessment of the variable.||mmHg||Standard Error|Least Squares Mean
749395|NCT00542269|Primary|Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study - Aliskiren/Amlodipine vs Ramipril/Amlodipine|Automated blood pressure determinations were made with the Omron HEM-705CP blood pressure monitor at trough (24 hours ± 3 hours post-dose) and recorded at all study visits following detailed directions specified in the study protocol. Three readings were made and msSBP was calculated as the average of the 3 readings. In the event of aberrant readings, ie, the lowest reading was ≥ 10 mmHg systolic or ≥ 5 mmHg diastolic lower than the highest of the 3 readings, 3 additional readings were obtained. A negative change indicates improvement.|Baseline to Week 12|Intent-to-treat (ITT) population. All patients that received at least 1 dose of study drug and had baseline and at least 1 post-baseline assessment of the variable.||mmHg||Standard Error|Least Squares Mean
749396|NCT00542269|Primary|Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study - Aliskiren/Ramipril/Amlodipine vs Ramipril/Amlodipine)|Automated blood pressure determinations were made with the Omron HEM-705CP blood pressure monitor at trough (24 hours ± 3 hours post-dose) and recorded at all study visits following detailed directions specified in the study protocol. Three readings were made and msSBP was calculated as the average of the 3 readings. In the event of aberrant readings, ie, the lowest reading was ≥ 10 mmHg systolic or ≥ 5 mmHg diastolic lower than the highest of the 3 readings, 3 additional readings were obtained. A negative change indicates improvement.|Baseline to Week 12|||mmHg||Standard Error|Least Squares Mean
749397|NCT00542308|Secondary|Tumour Response|Tumour response according to Response Evaluation Criteria in Solid Tumours (RECIST v 1.0)J Natl Cancer Inst 2000;92:205-16 assessed by CT/MRI. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the longest diameter of target lesions; Overall Response (OR), CR+PR|During treatment and two weeks after end of treatment, assessed up to 21 months.|All patients attending Visit 2 were included in the full analysis set irrespective of their compliance with the planned course of zalutumumab.||participants|||Number
749398|NCT00542308|Primary|Overall Survival|Overall survival was defined as time from start of treatment until date of death of any cause.|From randomization until death, assessed up to 21 months|All patients attending Visit 2 were included in the full analysis set irrespective of their compliance with the planned course of zalutumumab.||months||95% Confidence Interval|Median
749399|NCT00542321|Secondary|Turning-related Events|Non-serious adverse events that occurred during the time of rotation in the kinetic therapy bed group and during lateral rotation to right or left position in the manual turn group|Participants were followed for the duration of time on protocol, an average of 3.5 days.|All 8 patients enrolled in the kinetic therapy bed group and 7 of the 8 patients enrolled in the manual turn group (1 patient died after enrollment but before protocol could be initiated)||Events||Standard Deviation|Mean
749400|NCT00542321|Secondary|ICU All-cause Mortality.|Death from any reason between admission and discharge from study ICU|Participants were followed for the duration of ICU stay, an average of 10 days.|All 8 patients enrolled in the kinetic therapy bed group and 7 of the 8 patients enrolled in the manual turn group (1 patient died before start of study protocol)||participants|||Number
749401|NCT00542321|Secondary|ICU Length of Stay.|Time in days from study ICU admission to study ICU discharge or death|Participants were followed for the duration of ICU stay, an average of 10 days.|All 8 patients enrolled in kinetic therapy bed group and 7 of 8 patients enrolled in manual turn group (1 patient enrolled but died before started on protocol)||Days||Inter-Quartile Range|Median
749402|NCT00542321|Secondary|Mechanical Ventilation Duration.|Days on mechanical ventilation, from initiation to withdrawal of mechanical ventilation|Participants were followed for the duration of mechanical ventilation, an average of 5.5 days.|All 8 patients enrolled in kinetic therapy bed group and 7 of 8 patients enrolled in manual turn group (1 death before study protocol initiated)||Days||Standard Deviation|Mean
749403|NCT00542321|Primary|Incidence of Pulmonary Complications.|Number of participants who did not have preventable pulmonary complications (PPC) on pre-study chest radiograph (CXR) and developed PPC during the study period. Pearson Chi-Square test used to test significance of difference between turning groups.|Participants were followed for the duration of ICU stay, an average of 10 days.|Intention to treat; all 8 patients enrolled in kinetic therapy bed turn and 7 of 8 patients enrolled in manual turn (1 died before protocol initiated)||participants|||Number
749404|NCT00542386|Secondary|The Incidence of Adverse Events||12 weeks||||||
749405|NCT00542386|Secondary|The Change in Ca x P Ion Product||12 weeks||||||
749406|NCT00542386|Secondary|The Change in Ca||12 weeks||||||
749407|NCT00542386|Secondary|The Change in PTH||12 weeks||||||
749408|NCT00542386|Secondary|The Change in Triglycerides||12 weeks||||||
749409|NCT00542386|Secondary|The Change in HDL-cholesterol||12 weeks||||||
749410|NCT00542386|Secondary|The Change in Total-cholesterol||12 weeks||||||
749411|NCT00542386|Primary|The Change in LDL-cholesterol|The percentage change from baseline to week 12|12 weeks|ITT: The ITT population included all subjects who received a randomisation number, took study medication, and had at least 1 central laboratory serum phosphorus or LDL-C value after the start of study medication.||Percent change||Standard Deviation|Mean
749412|NCT00542386|Primary|The Change in Serum Phosphorus|The change from baseline to week 12|12 weeks|ITT: The ITT population included all subjects who received a randomisation number, took study medication, and had at least 1 central laboratory serum phosphorus or LDL-C value after the start||mg/dL||Standard Deviation|Mean
749418|NCT00542490|Secondary|Number of Patients With at Least One Toxicity Related to Vaginal Cuff Brachytherapy Followed by Carboplatin and Paclitaxel Chemotherapy||2 years|||Participants|||Count of Participants
749419|NCT00542490|Primary|Number of Patients With Progression-free Survival at 2 Years||2 years|19 of the 23 patients completed VCB and 3 cycles of chemotherapy||Participants|||Count of Participants
749460|NCT00543296|Secondary|Number of Participant's Eye Requiring Adjunctive Therapy|Adjunctive Therapy needed to control inflammation in the implanted eye|5 years|There were 14 participants studied with a total of 17 eyes implanted. Of the 17 eyes each could require separate adjunctive therapy||participant's eyes|Participants||Number
749420|NCT00542542|Primary|Proportion of Participants With No Pain Immediately After Surgery|Pain assessed using a verbal numeric rating scale (NRS) scored by numeric integers, with scores of 0-10 where 0 is no pain and 10 is the worst pain. Pain evaluated within the first hour, between 1 - 3 hours, between 3 - 6 hours post-operatively. Additional reporting planned for following morning (18 – 24 hours post-operatively).|Starting immediately after surgery, every 2 hours till the 6th hour following surgery|Analysis was not possible from data collected due to reporting inconsistencies.|||||
749421|NCT00542880|Secondary|The Clinical Chronic Obstructive Pulmonary Disease (COPD) Questionnaire (Change From Pre to End of Treatment)|The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate. Score scale 0 - 6 with 0=worst and 6 = best.|Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days|Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated.||Units on a scale||Standard Deviation|Mean
749422|NCT00542880|Secondary|Difficulty in Getting Out From Bed (MASQ) (Change From Pre to End of Treatment)|The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate. Score scale 0 - 5 with 0=worst and 5 = best.|Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days|Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated.||Units on a scale||Standard Deviation|Mean
749423|NCT00542880|Secondary|Capacity of Daily Living in the Morning (CDLM) (Change From Pre to End of Treatment)|The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate. Score scale 0 - 5 with 0=worst and 5 = best.|Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days|Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated.||units on a scale||Standard Deviation|Mean
749424|NCT00542880|Secondary|Change in Forced Vital Capacity (FVC) From Before Dose to5 Minutes After Dose at the Clinic|The change from pre-dose was calculated using the pre-dose baseline value (run-in and washout period respectively), and pre-dose value at day 1, with pre-dose run-in/washout as covariate.|Baseline (run-in, and washout) and day 1 of treatment period|Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated.||Liters||Standard Deviation|Mean
749425|NCT00542880|Secondary|Change in FEV1 From Before Dose to 5 Minutes After Dose at the Clinic|The change from pre-dose was calculated using the pre-dose baseline value (run-in and washout period respectively), and pre-dose value at day 1, with pre-dose run-in/washout as covariate.|Baseline (run-in, and washout) and day 1 of treatment period|Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated.||Liters||Standard Deviation|Mean
749426|NCT00542880|Secondary|Change in FEV1 From Before Dose to 15 Minutes After Dose in the Morning|The change from pre-dose was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with mean pre-dose run-in/washout as covariate.|Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days|Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated.||Liters||Standard Deviation|Mean
749427|NCT00542880|Secondary|Change in FEV1from Before Dose to 5 Minutes After Dose in the Morning|The change from pre-dose was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with mean pre-dose run-in/washout as covariate.|Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days|Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated.||Liters||Standard Deviation|Mean
749428|NCT00542880|Secondary|Change in PEF From Before Dose to 15 Minutes After Dose in the Morning|The change from pre-dose was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with mean pre-dose run-in/washout as covariate.|Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days|Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated.||Liters/minute||Standard Deviation|Mean
749429|NCT00542880|Secondary|Change in PEF From Before Dose to 5 Minutes After Dose in the Morning|The change from pre-dose was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with pre-dose run-in/washout as covariate.|Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days|Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated.||Liters/minute||Standard Deviation|Mean
749430|NCT00542880|Secondary|FEV1 Before Evening Dose|The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate.|Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days|Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated.||Liters||Standard Deviation|Mean
749431|NCT00542880|Secondary|FEV1 15 Minutes After Morning Dose|The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate.|Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days|Includes all subjects with at least one dose of study medication and contribute sufficient data for the endpoint to be calculated.||Liters||Standard Deviation|Mean
749432|NCT00542880|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Before Morning Dose|The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate.|Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days|Includes all subjects with at least one dose of study medication and contribute sufficient data for the endpoint to be calculated.||Liters||Standard Deviation|Mean
749433|NCT00542880|Secondary|PEF Before Evening Dose|The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate.|Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days|Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated.||Liters/minute||Standard Deviation|Mean
749434|NCT00542880|Secondary|PEF 15 Minutes After Morning Dose|The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate.|Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days|Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated.||Liters/minute||Standard Deviation|Mean
749435|NCT00542880|Secondary|PEF Before Morning Dose|The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate.|Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days|Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated.||Liters/minutes||Standard Deviation|Mean
749436|NCT00542880|Primary|Peak Expiratory Flow (PEF) 5 Minutes After Morning Dose|The change from baseline in PEF was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and all days of treatment, with baseline as covariate.|Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days|Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated.||liters/minute||Standard Deviation|Mean
749437|NCT00542971|Secondary|Number of Participants With Complete Response|Complete response was defined by the presence of < 5% blasts in the bone marrow (BM) with > 1 x 10^9/L platelets in the peripheral blood (PB).|Baseline to 2 years or disease progression.|||Participants|||Number
749438|NCT00542971|Primary|Maximum Tolerated Dose (MTD)|MTD is dose level where grade 3-4 sorafenib-attributable toxicity in <2 of 6 participants. Dose-Limiting Toxicity graded according to the NCI Common Toxicity Criteria version 3.0.|Twice a week for first two 28 day cycles|10 participants were treated with escalating doses of sorafenib with chemotherapy to establish the feasibility of the combination.||milligrams/twice a day (BID)|||Number
749439|NCT00542997|Other Pre-specified|Area Under the Concentration-Time Curve (AUCτ) of Total Serum IgG|AUCτ = Area under the concentration-time curve during regular dosing interval;|Week 28 (±1week)|Per Protocol Pharmacokinetic (PPK) population analysis. A total of 24 of the 51 enrolled subjects were included in a pharmacokinetic (PK) sub-study. 23 subjects completed the PK sub-study per protocol and were included in the PPK analysis population. 7 subjects were missing data for AUCτ.||day x g/L||Standard Deviation|Mean
749440|NCT00542997|Other Pre-specified|Area Under the Concentration-Time Curve (AUC_last) of Total Serum IgG|AUC_last = Area under the concentration-time curve until last measured concentration.|Week 28 (±1week)|Per Protocol Pharmacokinetic (PPK) population analysis. A total of 24 of the 51 enrolled subjects were included in a pharmacokinetic (PK) sub-study. 23 subjects completed the PK sub-study per protocol and were included in the PPK analysis population.||day x g/L||Standard Deviation|Mean
749441|NCT00542997|Other Pre-specified|Timepoint of Maximum Concentration (Tmax) of Total Serum IgG||Week 28 (±1week)|Per Protocol Pharmacokinetic (PPK) population analysis. A total of 24 of the 51 enrolled subjects were included in a pharmacokinetic (PK) sub-study. 23 subjects completed the PK sub-study per protocol and were included in the PPK analysis population.||day||Full Range|Median
749442|NCT00542997|Other Pre-specified|Maximum Concentration (Cmax) of Total Serum IgG||Week 28 (±1week)|Per Protocol Pharmacokinetic (PPK) population analysis. A total of 24 of the 51 enrolled subjects were included in a pharmacokinetic (PK) sub-study. 23 subjects completed the PK sub-study per protocol and were included in the PPK analysis population.||g/L||Standard Deviation|Mean
749443|NCT00542997|Secondary|Annual Rate of Antibiotic Use for Infection Prophylaxis and Treatment|The annual rate was calculated based on the total number of days of antibiotic use in the efficacy period divided by the total number of days in the efficacy period for all subjects and adjusted to 365 days.|Efficacy period: week 12 to week 40 after study start or to the completion visit|"ITT population analysis.
The intention-to-treat (ITT) data set comprises all subjects treated with the study drug during the efficacy period (week 13 to week 40 after study start or to the completion visit)."||days/subject/year|Participants||Number
749444|NCT00542997|Secondary|Annual Rate of the Number of Days of Hospitalization Due to Infections|The annual rate was calculated based on the total number of days of hospitalization due to infections in the efficacy period divided by the total number of days in the efficacy period for all subjects and adjusted to 365 days.|Efficacy period: week 12 to week 40 after study start or to the completion visit|"ITT population analysis.
The intention-to-treat (ITT) data set comprises all subjects treated with the study drug during the efficacy period (week 13 to week 40 after study start or to the completion visit)."||days/subject/year|Participants||Number
749445|NCT00542997|Secondary|Annual Rate of Days Out of Work / School / Kindergarten / Day Care or Unable to Perform Normal Activities Due to Infections|The annual rate was calculated based on the total number of days out of work/school/kindergarten/day care or unable to perform normal activities due to infections in the efficacy period divided by the total number of days in the efficacy period for all subjects and adjusted to 365 days.|Efficacy period: week 12 to week 40 after study start or to the completion visit|Intention-to-treat (ITT) population analysis. The ITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with Week 12).||days/subject/year|Participants||Number
749446|NCT00542997|Secondary|Annual Rate of Infection Episodes|The annual rate of episodes was calculated based on the total number of any infection type and the total number of study days during the efficacy period for all subjects in the ITT population and adjusted to 365 days.|Efficacy period: week 12 to week 40 after study start or to the completion visit|Intention-to-treat (ITT) population analysis. The ITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with Week 12).||episodes/subject/year|Participants|95% Confidence Interval|Number
750512|NCT00553332|Secondary|Toxicity Profile of AZD6244|Toxicitity will be assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 3.0|From the time of first treatment with AZD6244, assessed up to 4 weeks|||percent of patients|||Number
749447|NCT00542997|Secondary|Annual Rate of Clinically Documented Serious Bacterial Infections (PPE Population)|"Serious bacterial infections (SBIs) included bacterial pneumonia, bacteraemia/septicaemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess. Diagnosis of the SBIs was based on the presence of predefined clinical signs and symptoms as well as on laboratory parameters.
The annual rate was calculated based on the total number of SBIs and the total number of study days during the efficacy period for all subjects in the PPE population and adjusted to 365 days."|Efficacy period: week 12 to week 40 after study start or to the completion visit|Per Protocol Efficacy (PPE) population analysis. The PPE population included all subjects who completed the 28-week efficacy period according to protocol.||SBIs/subject/year|Participants||Number
749448|NCT00542997|Secondary|Annual Rate of Clinically Documented Serious Bacterial Infections (ITT Population)|"Serious bacterial infections (SBIs) included bacterial pneumonia, bacteraemia/septicaemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess. Diagnosis of the SBIs was based on the presence of predefined clinical signs and symptoms as well as on laboratory parameters.
The annual rate was calculated based on the total number of SBIs and the total number of study days during the efficacy period for all subjects in the ITT population and adjusted to 365 days."|Efficacy period: week 12 to week 40 after study start or to the completion visit|Intention-to-treat (ITT) population analysis. The ITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with Week 12).||SBIs/subject/year|Participants||Number
749449|NCT00542997|Primary|Total Serum IgG Trough Levels|Total IgG trough levels for IgPro20 treatment at steady state were compared with documented trough level data for IgG treatment received prior to enrolling in the study (either subcutaneous or intravenous IgG). For this purpose, 6 consecutive IgPro20 trough values (obtained prior to infusions 12 to 17) per subject were aggregated to the subject’s median value and then median values across subjects were summarised using descriptive statistics. The same procedure was applied to pre-study treatment using the 3 most recent IgG trough values ≥ 5 g/L obtained prior to the first IgPro20 infusion.|Up to 6 months prior to first IgPro20 treatment (Pre-study treatment) and Week 12 to 17 (IgPro20 treatment)|Intention-to-treat (ITT) population analysis. The ITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with Week 12). For 2 subjects in the ITT population, the pre-study treatment IgG trough levels were not available.||g/L||Standard Deviation|Mean
749450|NCT00543101|Secondary|Treatment Satisfaction (+3, Much More Satisfied Now to -3, Much Less Satisfied Now)|Participants in the experimental arm completed treatment satisfaction questionnaires at 24 weeks, and the control arm at 48 weeks (24 weeks after mid-study crossover to boosted darunavir). The questionnaires used numeric satisfaction scales (+3 much more satisfied now to -3 much less satisfied now). We reported the median and ranges for each question for each study arm.|24 weeks|||Units on a Scale (+3 to -3)||Full Range|Median
749451|NCT00543101|Secondary|Lipid Fraction Results, Mean of the Change From Baseline to Week 24.|We collected fasting total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides from all participants in both arms of the study. We calculated the differences between the values at week 24 and baseline for the participants in both arms. We reported the mean of the change from baseline to week 24.|baseline and 24 weeks|||mg/dL|||Number
749452|NCT00543101|Secondary|Economic Impact of a Substitution of Dual Boosted PIs With DRV/r|To assess the economic impact of DRV/r substitution for dual boosted PIs, we compared the average wholesale acquisition costs for the drugs in US Dollars ($) per month. The wholesale acquisition cost in US dollars ($) for each ART regimen was determined and the difference between the cost for the experimental and control groups was calculated and reported as US dollar savings per month.|48 weeks|||US dollars savings per month|||Number
749453|NCT00543101|Primary|The Percentage of Participants With Successful Virologic Suppression|Amount of HIV RNA copies per ml blood collected from subjects as measured by the Ultra-sensitive HIV-1 PCR (Roche Cobas). Successful virologic suppression is defined as < 50 copies/ml blood. The result is the percentage of participants with successful virologic suppression.|24 weeks|||Percentage of Participants|||Number
749454|NCT00543140|Secondary|Change in SF-36 Health Survey Mental Component at 5 Years Post Implant|Scores on the SF-36 Health Survey are determined by methodology publised with the validated instrument. Scores can range from 0 to 100 with higher scores indicating higher quality of life.|5 years|All subjects providing a measurement at the 5 year visit. No imputation of missing data was performed.||Unitless scale ranging 0 to 100||95% Confidence Interval|Mean
749455|NCT00543140|Secondary|Change in SF-36 Health Survey Physical Component at 5 Years Post Implant|Scores on the SF-36 Health Survey are determined by methodology publised with the validated instrument. Scores can range from 0 to 100 with higher scores indicating higher quality of life.|5 years|All subjects providing a measurement at the 5 year visit. No imputation of missing data was performed.||unitless scale ranging 0 to 100||95% Confidence Interval|Mean
749456|NCT00543140|Secondary|Percent Change in Excess Body Weight at 5 Years Post-implant||5 years|All subjects providing a measurement at the 5 year visit. No imputation of missing data was performed.||percentage of excess body weight||95% Confidence Interval|Mean
749457|NCT00543140|Secondary|Change in Glycosylated Hemoglobin (HbA1c) at 5 Years Post Implant.|The natural unit of measurement for HbA1c is percent (%). Results provided represent change from baseline, that is, Year 5 value minus Baseline value.|5 years|All subjects providing a measurement at the 5 year visit. No imputation of missing data was performed.||percentage||95% Confidence Interval|Mean
749458|NCT00543140|Primary|Re-operation Rate (Band Revision, Band Replacement and Explants Resulting From Serious Adverse Device-related Event {SADE}) of Gastric Banding at 4 and 5 Years Post Implant.|"A reoperation was identified by satisfying all of the following criteria:
Is an SAE or is the action taken as the result of an SAE;
Is related to the device (i.e., has a relationship to study device that is indicated as Definite, Probable, Possible, or Unknown). In cases where the reoperation is the action taken for an SAE, then the SAE itself should be related to the device;
Is an explant, band revision, or band replacement resulting from a medical condition (perceived failure of weight loss, subject request, and other non-medical conditions will not be counted); and
Has a start date that is strictly more than 1095 days (3 years) from the implantation of the device."|5 years|Consists of subjects who had a device implanted under protocol CI-07-0006 and subjects implanted under protocol CI-02-0006 and subsequently enrolled under protocol CI-06-0001.||percentage of subjects||95% Confidence Interval|Number
749459|NCT00543296|Secondary|Number of Eyes With Increased Intraocular Pressure||52 weeks|||eyes|Participants||Number
749463|NCT00543543|Other Pre-specified|Extension Study: Geometric Mean Titers to HPV Types 6/11/16/18/31/33/45/52/58 at Day 28 Postdose 4|Serum antibodies to HPV types 6/11/16/18/31/33/45/52/58 were measured with a Competitive Luminex Immunoassay. Titers are reported in milli Merck Units/mL. This outcome measure applied to Cohort 1 participants only.|Month 61: 28 days postdose 4 in the Extension Study (Cohort 1)|All participants in Cohort 1 who received all 3 vaccinations of mid-dose V503 in the Base Study, were seronegative at Day 1 and PCR negative from Day 1 to Month 7 for the relevant HPV types, had no other violation that could interfere with evaluation of immune response, and provided post-dose 4 serum.||milli Merck U/mL||95% Confidence Interval|Geometric Mean
749464|NCT00543543|Other Pre-specified|Extension Study: Geometric Mean Titers to HPV Types 6/11/16/18/31/33/45/52/58 at Day 7 Postdose 4|Serum antibodies to HPV types 6/11/16/18/31/33/45/52/58 were measured with a Competitive Luminex Immunoassay. Titers are reported in milli Merck Units/mL. This outcome measure applied to Cohort 1 participants only.|Month 60 + 1 week: Day 7 postdose 4 in the Extension Study (Cohort 1)|All participants in Cohort 1 who received all 3 vaccinations of mid-dose V503 in the Base Study, were seronegative at Day 1 and PCR negative from Day 1 to Month 7 for the relevant HPV types, had no other violation that could interfere with evaluation of immune response, and provided post-dose 4 serum.||milli Merck U/mL||95% Confidence Interval|Geometric Mean
749465|NCT00543543|Secondary|Base Study: Percentage of Participants Who Are Seropositive for HPV Types 6/11/16/18/31/33/45/52/58|Serum antibodies to HPV types were measured with a Competitive Luminex Immunoassay. The serostatus cutoffs (milli Merck U/mL) for HPV types were as follows: HPV Type 6: ≥30; HPV Type 11: ≥16; HPV Type 16: ≥20; HPV Type 18: ≥24; HPV Type 31: ≥10; HPV Types 33, 45, 52, and 58: ≥8.|4 weeks postdose 3|The Per-protocol Immunogenicity population included all participants who were not protocol violators, received all 3 vaccinations of mid-dose V503 or Gardasil within acceptable ranges, were seronegative at Day 1 and PCR negative from Day 1 - Month 7 for the relevant HPV types, and had a Month 7 serum sample collected within an acceptable range||Percentage of participants||95% Confidence Interval|Number
749466|NCT00543543|Secondary|Base Study: Combined Incidence of HPV Type 31/33/45/52/58-related Persistent Infection|Combined Incidence of HPV Type 31/33/45/52/58-related persistent infection as determined by clinical/pathologic criteria and positive Polymerase Chain Reaction (PCR) assay for virus subtype. Persistent infection was defined as infection detected in samples from >=2 consecutive visits 6 months (+/-1 month visit window) or longer apart. Incidence was defined as the number of cases of persistent infection per 10,000 person-years of follow-up in a treatment arm.|Up to Month 54 in the base study|The Per-protocol Efficacy population included all participants who received all 3 vaccinations of mid-dose V503 or Gardasil within acceptable day ranges, were seronegative at Day 1 and PCR negative at Day 1 through Day 7 to the relevant HPV types, and had at least 1 follow-up visit following Month 7.||Cases per 10,000 person-years follow-up|||Number
749467|NCT00543543|Primary|Base Study: Percentage of Participants With Study Medication Withdrawn Due to an Adverse Event|An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse event.|Up to Month 6|The analysis population included all participants who received >=1 vaccination and had safety follow-up||Percentage of participants|||Number
749468|NCT00543543|Primary|Base Study: Percentage of Participants With One or More Vaccine-related Adverse Event|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. An AE that is judged by the investigator to be “definitely related,” “probably related,” or “possibly related” to the study drug is defined as a vaccine-related AE.|Up to Month 7 (low- and high-dose V503) or up to Month 54 (mid-dose V503 and Gardasil)|The analysis population included all participants who received >=1 vaccination and had safety follow-up||Percentage of participants|||Number
749469|NCT00543543|Primary|Base Study: Percentage of Participants With One or More Non-injection-site (Systemic) Adverse Event|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Systemic AEs were those not categorized as injection-site AEs.|Up to Day 15 after any vaccination|The analysis population included all participants who received >=1 vaccination and had safety follow-up||Percentage of participants|||Number
749470|NCT00543543|Primary|Base Study: Percentage of Participants With One or More Injection-site Adverse Event|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. AEs such as redness, swelling, and pain/tenderness/soreness at the injection site were recorded.|Up to Day 5 after any vaccination|The analysis population included all participants who received >=1 vaccination and had safety follow-up||Percentage of participants|||Number
749471|NCT00543543|Primary|Base Study: Percentage of Participants With One or More Adverse Event|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE.|Up to Month 7 (low- and high-dose V503) or up to Month 54 (mid-dose V503 and Gardasil)|The analysis population included all participants who received >=1 vaccination and had safety follow-up||Percentage of participants|||Number
749472|NCT00543543|Other Pre-specified|Extension Study: Geometric Mean Titers to HPV Types 6/11/16/18/31/33/45/52/58 at Predose 4|Serum antibodies to HPV types 6/11/16/18/31/33/45/52/58 were measured with a Competitive Luminex Immunoassay. Titers are reported in milli Merck Units/mL. This outcome measure applied to Cohort 1 participants only.|Month 60: predose 4 in the Extension Study (Cohort 1)|All participants in Cohort 1 who received all 3 vaccinations of mid-dose V503 in the Base Study, were seronegative at Day 1 and PCR negative from Day 1 to Month 7 for the relevant HPV types, had no other violation that could interfere with evaluation of immune response, and provided post-dose 4 serum.||milli Merck U/mL||95% Confidence Interval|Geometric Mean
749473|NCT00543543|Primary|Base Study: Geometric Mean Titers (GMTs) to HPV Types 6/11/16/18/31/33/45/52/58|Serum antibodies to HPV types 6/11/16/18/31/33/45/52/58 were measured with a Competitive Luminex Immunoassay. Titers are reported in milli Merck Units/mL. Statistical analysis was performed only for HPV types contained in both vaccines.|4 weeks postdose 3 in the base study|The Per-protocol Immunogenicity population included all participants who were not protocol violators, received all 3 vaccinations of mid-dose V503 or Gardasil within acceptable ranges, were seronegative at Day 1 and PCR negative from Day 1- Month 7 for the relevant HPV types, and had a Month 7 serum sample collected within an acceptable range||milli Merck U/mL||95% Confidence Interval|Geometric Mean
749474|NCT00543543|Primary|Base Study: Combined Incidence of HPV Type 31/33/45/52/58-related Disease (End-of-study Update)|HPV Type 31/33/45/52/58-related high-grade Cervical Intraepithelial Neoplasia (CIN 2/3), Adenocarcinoma in Situ (AIS), Invasive Cervical Carcinoma, high-grade Vulvar Intraepithelial Neoplasia (VIN 2/3), high-grade Vaginal Intraepithelial Neoplasia (VaIN 2/3), vulvar cancer, or vaginal cancer were determined by clinical/pathologic criteria and positive Polymerase Chain Reaction (PCR) assay for virus subtype. This outcome measure reports cumulative study data through 10 March 2014. Disease incidence was defined as the number of primary efficacy cases per 10,000 person-years of follow-up in a treatment arm.|Up to Month 54 in the base study|The Per-protocol Efficacy population included all participants who received all 3 vaccinations of mid-dose V503 or Gardasil within acceptable day ranges, were seronegative at Day 1 and PCR negative at Day 1 through Day 7 to the relevant HPV types, and had at least 1 follow-up visit following Month 7.||Cases per 10,000 person-years follow-up|||Number
749475|NCT00543543|Primary|Base Study: Combined Incidence of HPV Type 31/33/45/52/58-related Disease (Test of Hypothesis)|HPV Type 31/33/45/52/58-related high-grade Cervical Intraepithelial Neoplasia (CIN 2/3), Adenocarcinoma in Situ (AIS), Invasive Cervical Carcinoma, high-grade Vulvar Intraepithelial Neoplasia (VIN 2/3), high-grade Vaginal Intraepithelial Neoplasia (VaIN 2/3), vulvar cancer, or vaginal cancer were determined by clinical/pathologic criteria and positive Polymerase Chain Reaction (PCR) assay for virus subtype. This outcome measure reports data based on the protocol-specified plan of conducting hypothesis testing when at least 30 cases had accumulated. The cutoff date for this analysis was 10 April 2013. Disease incidence was defined as the number of primary efficacy cases per 10,000 person-years of follow-up in a treatment arm.|From Day 1 until >=30 cases accumulate, up to Month 54 in the base study|The Per-protocol Efficacy population included all participants who received all 3 vaccinations of mid-dose V503 or Gardasil within acceptable day ranges, were seronegative at Day 1 and PCR negative at Day 1 through Day 7 to the relevant HPV types, and had at least 1 follow-up visit following Month 7.||Cases per 10,000 person-years follow-up|||Number
749476|NCT00543569|Secondary|Gastrointestinal Symptom Rating Scale Scores Over Time|The impact of gastrointestinal (GI) symptoms on health-related quality of life was assessed using the Gastrointestinal Symptom Rating Scale Scores (GSRS). The GSRS a 15-item self-administered questionnaire that assesses the impact of gastrointestinal symptoms during the past week on a scale from 1 (no discomfort at all) to 7 (very severe discomfort). Possible overall scores range from 1 to 7, with lower scores indicating a better quality of life with respect to gastrointestinal symptoms.|Months 1, 3, 6, and 12|"Full analysis set with available data at each time point (indicated by N)"||units on a scale||Standard Deviation|Mean
749477|NCT00543569|Secondary|Gastrointestinal Quality of Life Index Score Over Time|The impact of gastrointestinal (GI) symptoms on health-related quality of life was assessed using the Gastrointestinal Quality of Life Index (GIQLI) symptom severity score. The GIQLI is a 36-item self-administered questionnaire that assesses the impact of gastrointestinal symptoms during the past 2 weeks on a scale from 0 (all of the time) to 4 (never). Possible overall scores ranged from 0 to 4, with higher scores indicating a better quality of life according to the different symptomatic criteria.|Months 1, 3, 6, and 12|"Full analysis set with available data at each time point (indicated by N)"||units on a scale||Standard Deviation|Mean
749478|NCT00543569|Secondary|Percentage of Participants With Treatment Failure at Month 6 and 12|Treatment failure was defined as death, graft loss, BCAR (local review), lost to follow-up or early discontinuation of treatment regimen. The Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit.|6 months and 12 months|Full analysis set||percentage of participants||90% Confidence Interval|Number
749479|NCT00543569|Secondary|Percentage of Participants With Multiple Rejection Episodes at Months 6 and 12|All participants were evaluated for the incidence of multiple rejection episodes (clinically treated and/or BCAR as assessed by the local reviewer) through 6 months and 12 months.|6 months and 12 months|Full analysis set||percentage of participants||90% Confidence Interval|Number
749480|NCT00543569|Secondary|Percentage of Participants With Anti-lymphocyte-treated Rejection at Months 6 and 12|"Participants with histologically proved Banff Grade II or III rejection could receive anti-rejection therapy with anti-lymphocyte antibodies per institutional protocol.
The use of anti-lymphocyte antibody therapy at any time during a suspected or proven rejection episode for the treatment of acute rejection was considered an event."|6 months and 12 months|Full analysis set||percentage of participants||90% Confidence Interval|Number
749481|NCT00543569|Secondary|Percentage of Participants With Clinically Treated Acute Rejection at Month 6 and Month 12|Patients who received immunosuppressive medications for the treatment of suspected or BCAR were considered to have a clinically-treated acute rejection.|6 months and 12 months|Full analysis set||percentage of participants||90% Confidence Interval|Number
749482|NCT00543569|Secondary|Maximum Grade of T-cell Mediated Rejection as Assessed by Central Review|"The grade of acute T-cell mediated rejection was classified as IA, IB, IIA, IIB and III according to Banff 2005 criteria. If a patient had more than 1 T-cell mediated rejection, the episode with the most severe grade was used in the analysis.
Grade IA: Cases with significant interstitial infiltration (> 25% of parenchyma affected) and foci of moderate tubulitis; Grade IB: Cases with significant interstitial infiltration (> 25% of parenchyma affected) and foci of severe tubulitis; Grade IIA: Cases with mild to moderate intimal arteritis; Grade IIB: Cases with severe intimal arteritis comprising >25% of the luminal area; Grade III: Cases with transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation."|6 months and 12 months|Full analysis set||participants|||Number
750538|NCT00545779|Secondary|Percentage of Participants by Age and Activity Level Reporting High Satisfaction According to the Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) in Part B||Month 6|Analysis was not performed because the data were difficult or impossible to derive from the database.|||||
749483|NCT00543569|Secondary|Maximum Grade of T-cell Mediated Rejection Assessed by Local Review|"The grade of acute T-cell mediated rejection was classified as IA, IB, IIA, IIB and III according to Banff 2005 criteria. If a patient had more than 1 T-cell mediated rejection, the episode with the most severe grade was used in the analysis.
Grade IA: Cases with significant interstitial infiltration (> 25% of parenchyma affected) and foci of moderate tubulitis; Grade IB: Cases with significant interstitial infiltration (> 25% of parenchyma affected) and foci of severe tubulitis; Grade IIA: Cases with mild to moderate intimal arteritis; Grade IIB: Cases with severe intimal arteritis comprising >25% of the luminal area; Grade III: Cases with “transmural” arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation."|6 months and 12 months|Full analysis set||participants|||Number
749484|NCT00543569|Secondary|Time to First T-cell Mediated BCAR Assessed by Central Review|The time to first T-cell mediated BCAR (central review) was calculated as the first biopsy date in which the central reviewer confirmed an acute rejection minus the date of skin closure +1. Only participants with a T-cell mediated BCAR are included in the analysis.|12 months|Full analysis set with a T-cell mediated BCAR as assessed by the central reviewer||days||Full Range|Median
749485|NCT00543569|Secondary|Time to First T-cell Mediated BCAR Assessed by Local Review|The time to first T-cell mediated BCAR (local review) was calculated as the first biopsy date in which the local reviewer confirmed an acute rejection minus the date of skin closure +1.|12 months|Full analysis set with a T-cell mediated BCAR as assessed by local review||days||Full Range|Median
749486|NCT00543569|Secondary|Time to First BCAR Assessed by Central Review|The time to first BCAR (central review) was calculated as the first biopsy date in which the central reviewer confirmed an acute rejection minus the date of skin closure +1. Only participants with a BCAR are included in the analysis.|12 months|Full analysis set with a BCAR as assessed by the central reviewer||days||Full Range|Median
749487|NCT00543569|Secondary|Time to First BCAR Assessed by Local Review|The time to first BCAR (local review) was calculated as the first biopsy date in which the local reviewer confirmed an acute rejection minus the date of skin closure +1. Only participants with a BCAR are included in the analysis.|12 months|Full analysis set with a BCAR assessed by local review||days||Full Range|Median
749488|NCT00543569|Secondary|Percentage of Participants With Efficacy Failure at 6 and 12 Months Assessed by Central Review|Efficacy failure is defined as death, graft failure (permanent return to dialysis [>30 days] or retransplant), BCAR according to central review, or lost to follow-up.|6 months and 12 months|Full analysis set||percentage of participants||90% Confidence Interval|Number
749489|NCT00543569|Secondary|Percentage of Participants With Efficacy Failure at 6 and 12 Months Assessed by Local Review|Efficacy failure is defined as death, graft failure (permanent return to dialysis [>30 days] or retransplant), BCAR according to local review, or lost to follow-up.|6 months and 12 months|Full analysis set||percentage of participants||90% Confidence Interval|Number
749490|NCT00543569|Secondary|Change From Week 4 in Serum Creatinine at Month 6 and 12||Week 4 and Month 6 and 12|"Full analysis set with available data at Week 4. N indicates participants with available data at each time point."||mg/dL||Standard Deviation|Mean
749491|NCT00543569|Secondary|Change From Week 4 in GFR by Iothalamate Clearance at Month 6|The glomerular filtration rate was measured directly using iothalamate clearance.|Week 4 and Month 6|"Full analysis set with available data at Week 4. N indicates participants with available data at Week 4 and Month 6."||mL/min per 1.73 m^2||Standard Deviation|Mean
749492|NCT00543569|Secondary|Change From Week 4 in Glomerular Filtration Rate Estimated by the MDRD Method at Month 6 and Month 12|The glomerular filtration rate (GFR) was calculated using the Modification of Diet in Renal Disease (MDRD) method.|Week 4, Month 6 and Month 12|"Full analysis set with available data at Week 4. N indicates the number of participants with available data at each time point."||mL/min per 1.73 m^2||Standard Deviation|Mean
749493|NCT00543569|Secondary|Percentage of Participants With T-cell Mediated BCAR at Month 6 and 12 Assessed by Central Review|"Rejection episodes were confirmed by biopsy by the central reviewer. Biopsies were graded according to the 2005 Banff criteria. All biopsies of grade 1 or higher were considered a BCAR.
The Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit."|6 months and 12 months|Full analysis set||percentage of participants||90% Confidence Interval|Number
749494|NCT00543569|Secondary|Percentage of Participants With T-cell Mediated BCAR at Month 6 and 12 Assessed by Local Review|"Rejection episodes were confirmed by biopsy by the clinical site pathologist. Biopsies were graded according to the 2005 Banff criteria. All biopsies of grade 1 or higher were considered a BCAR.
The Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit."|6 months and 12 months|Full analysis set||percentage of participants||90% Confidence Interval|Number
749495|NCT00543569|Secondary|Percentage of Participants With BCAR at Month 6 and 12 Assessed by Central Review|"Rejection episodes were confirmed by biopsy by a central reviewer. Biopsies were graded according to the 2005 Banff criteria. All biopsies (T-cell and/or antibody mediated) of grade 1 or higher were considered a BCAR.
The Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit."|6 months and 12 months|Full analysis set||percentage of participants||90% Confidence Interval|Number
749496|NCT00543569|Secondary|Percentage of Participants With BCAR at Month 12 Assessed by Local Review|"Rejection episodes were confirmed by biopsy by the clinical site pathologist. Biopsies were graded according to the 2005 Banff criteria. All biopsies (T-cell and/or antibody mediated) of grade 1 or higher were considered a BCAR.
The Kaplan-Meier estimates at Day 365 was used for the analyses at 12 months. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit."|12 months|Full analysis set||percentage of participants||90% Confidence Interval|Number
749497|NCT00543569|Secondary|Graft Survival at Month 6 and Month 12|"Graft survival was defined as any participant who was known to have a functioning graft (i.e., not graft loss) at 6 months and 12 months after the skin closure date. Graft loss was defined as patient death, retransplant, permanent return to dialysis (dialysis greater than 30 days) or transplant nephrectomy.
The Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit."|6 months and 12 months|Full analysis set||percentage of participants||90% Confidence Interval|Number
749498|NCT00543569|Secondary|Patient Survival at Month 6 and Month 12|"Patient survival is any participant who is known to be alive 6 months and 12 months after the skin closure date.
The Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit."|6 months and 12 months|Full analysis set||percentage of participants||90% Confidence Interval|Number
749499|NCT00543569|Primary|Percentage of Participants With Biopsy-confirmed Acute Rejection (BCAR) at Month 6 Assessed by Local Review|"Rejection episodes were confirmed by biopsy by the clinical site pathologist. Biopsies were graded according to the 2005 Banff criteria. All biopsies (T-cell and/or antibody mediated) of grade 1 or higher were considered a BCAR.
The Kaplan-Meier estimates at Day 182 was used for the analyses at 6 months. Lost to follow-up or patients with missing outcomes were censored at their last follow up visit."|6 months|Full analysis set||percentage of participants||90% Confidence Interval|Number
749500|NCT00543725|Secondary|Number of Participants With Virologic Failure for the Resistance Determinations by Developing Mutations: First Available On-Treatment Genotypic Data After Failure|Virologic failure for the resistance determinations was defined as lack of virologic response (never having had 2 consecutive plasma viral load <50 copies/mL) and plasma viral load increase of >=0.5 log 10 copies/mL above nadir (i.e., never suppressed), or confirmed loss of virologic response (2 consecutive plasma viral load >=50 copies/mL after having had 2 consecutive plasma viral load <50 copies/mL; i.e., rebounder), or discontinued with a last observed on-treatment plasma viral load >=50 copies/mL after having had 2 consecutive plasma viral load <50 copies/mL. For this study, treatment-emergent reverse transcriptase (RT) resistance associated mutations (RAMs) occurring in at least 2 virologic failures (for at least one treatment group) for the following lists are presented: i) Extended list of Non-nucleoside reverse transcriptase inhibitor (NNRTI RAMs) ii) IAS-USA list of Nucleoside/tide reverse transcriptase inhibitor (N[t]RTI RAMs).|Week 96|"The Intent-to-Treat analysis set was considered the primary efficacy analysis set. Here N (Number of Participants Analyzed) signifies number of Participants who were evaluable (had data) for this outcome."||Participants|||Number
749501|NCT00543725|Secondary|Mean Change From Baseline to Week 48 and Week 96 in Absolute and Relative CD4+ Cell Counts (Using Imputed Data)|Change from baseline in CD4+ cell count was imputed in case of missing values: in case of premature discontinuation, data were imputed with the baseline value after discontinuation (i.e. change=0, Non-Completer [NC] = Failure); otherwise last observation carried forward was applied.|Baseline, Week 48, and Week 96|The Intent-to-Treat analysis set was considered the primary efficacy analysis set.||cells per microliter||95% Confidence Interval|Mean
749502|NCT00543725|Secondary|Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <400 Copies Per mL) at Week 96|Virological response is defined as confirmed plasma viral load < 400 HIV-1 (RNA) copies/mL at Week 96. The TLOVR algorithm was used to derive response. Response needed to be confirmed at 2 consecutive visits and participants who permanently discontinued were considered nonresponders after discontinuation. Resuppression after confirmed virologic failure was considered as failure. Virologic Failure includes participants who were rebounder (confirmed viral load >= 400 copies/mL after being responder) or who were never suppressed (no confirmed viral load <400 copies/mL).|Week 96|The Intent-to-Treat analysis set was considered the primary efficacy analysis set.||Participants|||Number
749503|NCT00543725|Secondary|Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <400 Copies Per mL) at Week 48|Virological response is defined as confirmed plasma viral load < 400 HIV-1 (RNA) copies/mL at Week 48. The TLOVR algorithm was used to derive response. Response needed to be confirmed at 2 consecutive visits and participants who permanently discontinued were considered nonresponders after discontinuation. Resuppression after confirmed virologic failure was considered as failure. Virologic Failure includes participants who were rebounder (confirmed viral load >= 400 copies/mL after being responder) or who were never suppressed (no confirmed viral load <400 copies/mL).|Week 48|The Intent-to-Treat analysis set was considered the primary efficacy analysis set.||Participants|||Number
749504|NCT00543725|Secondary|Number of Participants With Virological Response (Observed, <50 Copies/mL) at Last On-Treatment Visit (Post-Week 96).|Virological response is defined as (observed) plasma viral load less than 50 human immunodeficiency virus-type 1 (HIV-1) ribonucleic acid (RNA) copies per mL at the last on-treatment post-Week 96 visit.|Variable, ranging from 3 months up to maximum 18 months for TMC278 and 12 months for Efavirenz|Participants with at least 1 Post-Week 96 visit were included in the analysis.||Participants|||Number
749505|NCT00543725|Secondary|Number of Participants With Virological Response (Intent-to-Treat - Snapshot, <50 Copies Per mL) at Week 96||Week 96|The Intent-to-Treat analysis set was considered the primary efficacy analysis set.||Participants|||Number
749506|NCT00543725|Secondary|Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies Per mL) at Week 96||Week 96|The Intent-to-Treat analysis set was considered the primary efficacy analysis set.||Participants|||Number
749507|NCT00543725|Secondary|Number of Participants With Virological Response (Intent-to-Treat - Snapshot, <50 Copies Per mL) at Week 48|The analysis is based on the last observed viral load (VL) data within the Week 48 window. Virologic response is defined as a VL<50 copies/mL (observed case). Missing VL was considered as non-response. Virologic Failure includes subjects who had VL>=50 copies/mL in the Wk 48 window, subjects who discontinued early due to lack or loss of efficacy, subjects who discontinued for reasons other than an adverse event, death or lack or loss of efficacy and at the time of discontinuation had a VL>=50 copies/mL and subjects who had a switch in background regimen that was not permitted by the protocol.|Week 48|The Intent-to-Treat analysis set was considered the primary efficacy analysis set.||Participants|||Number
749508|NCT00543725|Primary|Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies Per mL) at Week 48|Virological response is defined as confirmed plasma viral load less than (<) 50 human immunodeficiency virus-1 (HIV-1) (ribonucleic acid [RNA]) copies/milliliter (ml) at Week 48. The TLOVR algorithm was used to derive response. Response needed to be confirmed at 2 consecutive visits and participants who permanently discontinued were considered nonresponders after discontinuation. Resuppression after confirmed virologic failure was considered as failure. Virologic Failure includes participants who were rebounder (confirmed viral load >= 50 copies/ml after being responder) or who were never suppressed (no confirmed viral load <50 copies/ml).|Week 48|The Intent-to-Treat analysis set was considered the primary efficacy analysis set.||Participants|||Number
749511|NCT00543803|Secondary|Number of Patients With Non-serious Drug-related AEs as Judged by the Investigator|Total number of patients with investigator defined non-serious drug-related AEs was reported.|from baseline to last value on treatment in between 36 months|FAS- All patients were considered for the full analysis set.||participants|||Number
749512|NCT00543803|Secondary|Summary of Change From Baseline in CD4+ Count to Last Value on Treatment||from baseline to last value on treatment in between 36 months|FAS- All patients were considered for the full analysis set.||(cells) / mm^3||Inter-Quartile Range|Median
749513|NCT00543803|Secondary|Summary of Log10 Change From Baseline in Viral Load to Last Value on Treatment|For calculation of this measure switch patients are included in the total which had no viral load decrease.|from baseline to last value on treatment in between 36 months|FAS- All patients were considered for the full analysis set.||(log10 copies) / ml||Inter-Quartile Range|Median
749514|NCT00543803|Primary|Summary of Change From Baseline in Glucose to Last Value on Treatment|The change in Glucose from baseline to the last value in treatment|from baseline to last value on treatment in between 36 months|FAS- All patients were considered for the full analysis set.||mg/dl||Inter-Quartile Range|Median
749515|NCT00543803|Primary|Summary of Change From Baseline in Triglycerides to Last Value on Treatment|The change in triglycerides from baseline to the last value in treatment|from baseline to last value on treatment in between 36 months|FAS- All patients were considered for the full analysis set.||mg/dl||Inter-Quartile Range|Median
749516|NCT00543803|Primary|Summary of Change From Baseline in Low-density Lipoprotein (LDL) Cholesterol to Last Value on Treatment|The change in Low-density lipoprotein (LDL) cholesterol from baseline to the last value in treatment|from baseline to last value on treatment in between 36 months|FAS- All patients were considered for the full analysis set.||mg/dl||Inter-Quartile Range|Median
749517|NCT00543803|Primary|Summary of Change From Baseline in High-density Lipoprotein (HDL) Cholesterol to Last Value on Treatment|The change in High-density lipoprotein (HDL) cholesterol from baseline to the last value in treatment|from baseline to last value on treatment in between 36 months|FAS- All patients were considered for the full analysis set.||mg/dl||Inter-Quartile Range|Median
749518|NCT00543803|Primary|Summary of Change From Baseline in Total Cholesterol to Last Value on Treatment|The change in total cholesterol from baseline to the last value in treatment|from baseline to last value on treatment in between 36 months|FAS- All patients were considered for the full analysis set.||mg/dl||Inter-Quartile Range|Median
749519|NCT00543803|Primary|Summary of Change From Baseline in Creatinine to Last Value on Treatment|The change in Creatinine from baseline to the last value in treatment|from baseline to last value on treatment in between 36 months|FAS- All patients were considered for the full analysis set.||mg/dl||Inter-Quartile Range|Median
749520|NCT00543803|Primary|Summary of Change From Baseline in Gamma-glutamyl Transferase (Gamma-GT) to Last Value on Treatment|The change in Gamma-glutamyl transferase (Gamma-GT) from baseline to the last value in treatment|from baseline to last value on treatment in between 36 months|FAS- All patients were considered for the full analysis set.||IU/L||Inter-Quartile Range|Median
749521|NCT00543803|Primary|Summary of Change From Baseline in Asparate Aminotransferase (AST) to Last Value on Treatment|The change in asparate aminotransferase (AST) from baseline to the last value in treatment|from baseline to last value on treatment in between 36 months|FAS- All patients were considered for the full analysis set.||IU/L||Inter-Quartile Range|Median
749522|NCT00543803|Primary|Summary of Change From Baseline in Alanine Aminotransferase (ALT) to Last Value on Treatment|The change in alanine aminotransferase (ALT) from baseline to the last value in treatment|from baseline to last value on treatment in between 36 months|FAS- All patients were considered for the full analysis set.||IU/L||Inter-Quartile Range|Median
749523|NCT00543855|Primary|Burden on Caregiver: Change From Baseline in J-ZBI (Japanese- Zarit Caregiver Burden Interview) Total at Week 12 Last Observation Carried Forward (LOCF)|"J-ZBI is a Japanese version instrument to measure and assess the level of burden experienced by the principal caregivers of participants with dementia.
ZBI contains 22 items, in which each statement is scored by the caregiver using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always). Total score derived from sub-scores; total ranged from 0-88. Higher scores indicate greater burden. Change: mean score at Week 12 LOCF minus mean score at baseline. Values at final evaluation were imputed using a Last Observation Carried Forward (LOCF) method."|Baseline and Week 12|Per Protocol Set (PPS) was defined as those participants who complied with the study protocol.||Score on a scale||Standard Deviation|Mean
749524|NCT00543855|Primary|Global Clinical Function: Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus) Total at Week 12 Last Observation Carried Forward (LOCF)|"CIBIC plus is a clinician's interview-based impression of change plus the caregiver's input. It is a seven-point categorical assessment scale for evaluating global clinical function, ranging from markedly improved” to “markedly worse”. Percentage of participants in each category were reported. Values at final evaluation were imputed using a Last Observation Carried Forward (LOCF) method."|Baseline and week 12|Per Protocol Set (PPS) was defined as those participants who complied with the study protocol.||Percentage of Participants|||Number
749525|NCT00543855|Primary|Psychiatric Symptoms: Change From Baseline in Neuropsychiatric Inventory (NPI) Total at Week 12 Last Observation Carried Forward (LOCF)|"NPI measured 10 different domains of psychiatric symptoms including delusion and hallucination. Each domain is scored for: present or absent, frequency, and severity. The score derived from sub-scores; total ranged from 0 to 120, higher score indicated worse neuropsychiatric outcomes. Change: mean score at Week 12 LOCF minus mean score at baseline. Values at final evaluation were imputed using a Last Observation Carried Forward (LOCF) method."|Baseline and every 4 weeks up to 12 weeks|Per Protocol Set (PPS) was defined as those participants who complied with the study protocol.||Score on a scale||Standard Deviation|Mean
749526|NCT00543855|Primary|Cognitive Function: Change From Baseline in Mini-mental State Examination (MMSE) Total at Week 12 Last Observation Carried Forward (LOCF)|MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranged from 0 - 30, where a higher score indicated better cognitive state. Change: mean score at Week 12 LOCF minus mean score at baseline. Values at final evaluation were imputed using a Last Observation Carried Forward (LOCF) method.|Baseline and every 4 weeks up to 12 weeks|Per Protocol Set (PPS) was defined as those participants who complied with the study protocol.||Score on a scale||Standard Deviation|Mean
763684|NCT00670540|Secondary|Percentage of Participants Who Died From Any Cause||at 3 years|||percentage of participants||95% Confidence Interval|Number
749527|NCT00543985|Secondary|Change in Maximal Oxygen Uptake (VO2 Max)|Measure of the maximum volume of oxygen that a body is capable of utilizing in one minute, measured in milliliters per kilogram of body weight per minute (ml/kg/min) Measured in all participants immediately following treadmill stress test.|12 weeks|This data, if analyzed, is unavailable as the PI/study staff left the institution before completing the analysis and without making results available.|||||
749528|NCT00543985|Secondary|Mean Resting Maximal Oxygen Uptake (VO2 Max)|Measure of the maximum volume of oxygen that a body is capable of utilizing in one minute, measured in milliliters per kilogram of body weight per minute (ml/kg/min). Measured in all participants prior to treadmill stress test.|12 weeks|This data, if analyzed, is unavailable as the PI/study staff left the institution before completing the analysis and without making results available.|||||
749529|NCT00543985|Primary|Post-exercise E/E'|E/E' is an echocardiographic parameter where E = early mitral inflow velocity and E' = early diastolic mitral annular motion. Measured in all participants immediately following treadmill stress test.|12 weeks|The echo results from all subjects were analyzed at rest and following maximal exercise testing.||ml/min/kg||Standard Error|Mean
749530|NCT00543985|Primary|Mean Resting E/E'|E/E' is an echocardiographic parameter where E = early mitral inflow velocity and E' = early diastolic mitral annular motion. Measured in all participants prior to treadmill stress test.|12 weeks|The echo results from all subjects were analyzed at rest and following maximal exercise testing.||ml/min/kg||Standard Error|Mean
749531|NCT00544167|Primary|The Safety and Tolerability of Protocol Treatment, Defined as the Percentage of Patients Experiencing Severe or Life-threatening Side Effects Per CTCAE Version 3.0.||18 Months|||percentage of patients|||Number
749532|NCT00544440|Secondary|Number of Participants With Change in Markers of Bone Metabolism||Week 8|Data was reported in individual participant listings but not summarized due to statistical constraints.|||||
749533|NCT00544440|Primary|Difference in Bone Marrow Testosterone Levels Between Participants With and Without Serum Prostate Specific Antigen Decline||Week 8|Since there were too few participants with any detectable bone marrow testosterone, this analysis was not performed.|||||
749534|NCT00544440|Primary|Number of Participants With Detectable Bone Marrow Dihydrotestosterone (DHT) Level (>9 Picograms/Mililiter)||Baseline (predose Week 1 Day 1) and Week 8|Bone marrow aspirates were collected at baseline (predose Week 1 Day 1) in 49 participants and in 44 participants at Week 8.||Number of Participants|||Number
749535|NCT00544440|Primary|Number of Participants With Detectable Bone Marrow Testosterone Level (>1 Picograms/Mililiter)||Baseline (predose Week 1 Day 1) and Week 8|Bone marrow aspirates were collected at baseline (predose Week 1 Day 1) in 49 participants and in 44 participants at Week 8.||Number of Participants|||Number
749536|NCT00544544|Secondary|Clinical Global Impression Scale||6 weeks||||||
749537|NCT00544544|Secondary|Young Mania Rating Scale||6 weeks||||||
749538|NCT00544544|Secondary|Montgomery Asberg Depression Rating Scale||6 weeks||||||
749539|NCT00544544|Primary|Change in Hamilton Depression Rating Scale|The Hamilton Depression rating Scale is a clinician-rated scale that measures the severity of depression symptoms using 21 items. The best score is zero (reflecting no depression) and the worst score is 63 (reflecting severe depression).|Change from baseline to week 6|||units on a scale||95% Confidence Interval|Mean
749540|NCT00544557|Secondary|Percentage of Participants With Discontinuation of Treatment Due to Adverse Events|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|Baseline up to Week 52|Safety population included all treated participants with available post­-baseline safety data.||percentage of participants|||Number
749541|NCT00544557|Secondary|Percentage of Participants With Prior or Concomitant Medication Use for Treatment of Ankylosing Spondylitis|Participants taking any non-study medications which were administered either prior to or during the study treatment for AS were reported.|Baseline up to Week 52|Safety population included all treated participants with available post-baseline safety data.||percentage of participants|||Number
749542|NCT00544557|Secondary|Duration of Healthcare Resources Utilization|Participants duration of healthcare resources utilization was evaluated as number of days for healthcare resources utilization including: duration of visits to general practitioners, to rheumatologist, to other medical specialists, inpatient hospitalizations, inpatient rehabilitations, inpatient follow-up treatment, outpatient rehabilitations, physiotherapy, and other healthcare utilizations. At baseline, number of days for participants’ healthcare resources utilizations during last 12 months before enrollment into the study were documented. After enrollment, number of days for participants’ healthcare resources utilization were documented for last 6 months after previous documentation.|Baseline, Week 26, 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.||days||Standard Deviation|Mean
749543|NCT00544557|Secondary|Healthcare Resource Utilization|Participants utilization of healthcare resources was evaluated as number of events for healthcare resources utilization including: number of visits to general practitioners, visits to rheumatologist, visits to other medical specialists, inpatient hospitalizations, inpatient rehabilitations, inpatient follow-up treatment, outpatient rehabilitations, physiotherapy, and other healthcare utilizations. At baseline, number of events for participants’ healthcare resources utilization during last 12 months before enrollment into the study were documented. After enrollment, number of events for participants’ healthcare resources utilization were documented for last 6 months after previous documentation.|Baseline, Week 26, 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here ‘N’ signifies participants evaluable for this outcome measure and 'n' signifies participants evaluable for this measure at given time points.||events||Standard Deviation|Mean
749552|NCT00544557|Secondary|Percentage of Participants With Presence of Enthesitis|Enthesitis is the inflammation of the enthesis, where the joint capsules, ligaments or tendons attach to the bone. This inflammation can lead to severe pain and discomfort.|Baseline, Week 2, 6, 12, 26, 38, 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here ‘N’ signifies participants evaluable for this outcome measure and 'n' signifies participants evaluable for this measure at given time points.||percentage of participants|||Number
749544|NCT00544557|Secondary|Work Productivity and Activity Impairment - Special Health Problems (WPAI:SHP)|WPAI:SHP is 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to rheumatoid arthritis for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.|Baseline, Week 26, 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.||percentage of impairment||Standard Deviation|Mean
749545|NCT00544557|Secondary|Euro Quality of Life (EQ­-5D)- Visual Analog Scale (VAS)|EQ-5D: participant rated questionnaire to assess health-related quality of life. Health. State Profile component assesses level of current health for 5 domains: mobility, self care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicate worst health state. Score of each domain is transformed into a single VAS score using formula developed by Greiner et al and results in a total score range of 0 to 100, where higher score indicates a better health state.|Baseline, Week 26, 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.||units on a scale||Standard Deviation|Mean
749546|NCT00544557|Secondary|Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO)|EQ 5D: participant rated questionnaire to assess health-related quality of life. Health State Profile component assesses level of current health for 5 domains: mobility, self­care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (extreme problems). Score of each domain is transformed into a single TTO value using formula developed by Greiner et al and results in a total score range -0.205 to 0.999, higher score indicates a better health state.|Baseline, Week 26, 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.||units on a scale||Standard Deviation|Mean
749547|NCT00544557|Secondary|Percentage of Participants With Assessment in Ankylosing Spondylitis 40 (ASAS-40) Response|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants. ASAS =4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40= at least (>=) 40 percent improvement from baseline and an absolute change >=2 unit on a 0-10 numeric scale (0=no disease activity; 10=high disease activity) in at least 3 of the domains (on a 0–10 numerical scale): Global assessment of disease activity by participant, participant's global pain intensity, function measured by BASFI and inflammation measured by the average of the last two Likert-scales in BASDAI concerning morning stiffness intensity and duration and no worsening in the remaining domain.|Week 12, 26, 38, 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.||percentage of participants||95% Confidence Interval|Number
749548|NCT00544557|Secondary|Percentage of Participants With Assessment in Ankylosing Spondylitis 20 (ASAS-20) Response|ASAS measures symptomatic improvement in AS participants. ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20= at least >= 20 percent improvement from baseline and an absolute change >=1 unit on a 0-10 numeric scale (0=no disease activity; 10=high disease activity) in at least 3 of the domains (on a 0–10 numerical scale): Global assessment of disease activity by participant, participant's global pain intensity, function measured by BASFI and inflammation measured by the average of the last two Likert-scales in BASDAI concerning morning stiffness intensity and duration and no worsening in the remaining domain.|Week 12, 26, 38, 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.||percentage of participants||95% Confidence Interval|Number
749549|NCT00544557|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 52|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeter/hour (mm/hr). A higher rate is consistent with inflammation.|Baseline, Week 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.||mm/hr||Standard Deviation|Mean
749550|NCT00544557|Secondary|Change From Baseline in C-Reactive Protein (CRP) at Week 52|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.||milligram per deciliter (mg/dL)||Standard Deviation|Mean
749551|NCT00544557|Secondary|Change From Baseline in Number of Affected Body Parts by Enthesitis at Week 52|Enthesitis is the inflammation of the enthesis, where the joint capsules, ligaments or tendons attach to the bone. This inflammation can lead to severe pain and discomfort. In case of no presence of enthesitis the number of affected body parts was set to 0.|Baseline, Week 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.||body parts||Standard Deviation|Mean
750539|NCT00545779|Secondary|Percentage of Participants Who Reported an Improvement in the Frequency of Gastro-intestinal (GI) Symptoms Per Month in Part B||Baseline to Month 6|Analysis was not performed because the data were difficult or impossible to derive from the database.|||||
749553|NCT00544557|Secondary|Change From Baseline in Number of Affected Joints by Peripheral Arthritis at Week 52|Peripheral arthritis is the inflammation of joints that involved asymmetrically. It involved the hips, shoulder girdle (glenohumeral, acromioclavicular, and sternoclavicular joints), joints of the chest wall (costovertebral joints, costosternal junctions) and symphysis pubis. In case of no presence of peripheral arthritis the number of affected joints was set to 0.|Baseline, Week 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here ‘N’ signifies participants evaluable for this outcome measure and 'n' signifies participants evaluable for this measure at given time points.||joints||Standard Deviation|Mean
749554|NCT00544557|Secondary|Percentage of Participants With Presence of Peripheral Arthritis|Peripheral arthritis is the inflammation of joints that involved asymmetrically. It involved the hips, shoulder girdle (glenohumeral, acromioclavicular, and sternoclavicular joints), joints of the chest wall (costovertebral joints, costosternal junctions) and symphysis pubis.|Baseline, Week 2, 6, 12, 26, 38, 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here ‘N’ signifies participants evaluable for this outcome measure and 'n' signifies participants evaluable for this measure at given time points.||percentage of participants|||Number
749555|NCT00544557|Secondary|Percentage of Participants With Significant Reduction of Morning Stiffness|Duration of morning stiffness is defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes. A significant reduction of duration of morning stiffness is defined as a reduction of the duration in minutes by at least 20 percent or reduction to 'no morning stiffness' (absence of morning stiffness).|Week 2, 6, 12, 26, 38, 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here ‘N’ signifies participants evaluable for this outcome measure and 'n' signifies participants evaluable for this measure at given time points.||percentage of participants|||Number
749556|NCT00544557|Secondary|Change From Baseline in Duration of Morning Stiffness at Week 52|Duration of morning stiffness is defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes.|Baseline, Week 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.||minutes||Standard Deviation|Mean
749557|NCT00544557|Secondary|Change From Baseline in Physician Global Assessment (PGA) of Disease Activity at Week 52|Physicians were asked to assess the disease activity of participants within the past 7 days. Disease activity was evaluated on an 11-point Likert scale: min = 0 (best), max = 10 (worst).|Baseline, Week 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.||units on a scale||Standard Deviation|Mean
749558|NCT00544557|Secondary|Change From Baseline in Patient Global Assessment (PtGA) of Disease Activity at Week 52|Participants were asked to assess their disease activity within the past 7 days. Disease activity was evaluated on an 11-point Likert scale: min = 0 (best), max = 10 (worst).|Baseline, Week 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.||units on a scale||Standard Deviation|Mean
749559|NCT00544557|Secondary|Change From Baseline in Patient's Global Assessment (PtGA) of Pain at Week 52|Participants were asked to assess their global pain intensity within the past 7 days. Pain was evaluated on an 11-point Likert scale: min = 0 (best), max = 10 (worst).|Baseline, Week 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.||units on a scale||Standard Deviation|Mean
749560|NCT00544557|Secondary|Change From Baseline in Lateral Lumbar Flexion at Week 52|Lateral lumbar flexion was determined by the difference of the finger-floor-distance in normal position and in lateral bending position.|Baseline, Week 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.||cm||Standard Deviation|Mean
749561|NCT00544557|Secondary|Change From Baseline in Occiput-to-Wall Distance at Week 52|Occiput-to-wall distance is the distance between the occiput (posterior or back portion of the head) and the wall when the participant stood with heels and shoulder against the wall and the back straight.|Baseline, Week 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here ‘n' signifies participants evaluable for this measure at given time points.||centimeter (cm)||Standard Deviation|Mean
749562|NCT00544557|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 52|BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Participants answered 10 questions, consisting of 8 specific questions regarding function in AS and 2 questions reflecting the participant's ability to cope with everyday life. Each question was answered on a 0–10 scale (0 being no problem and 10 being the worst problem), the sum of which (divided by 10) resulted in the BASFI score (0–10).|Baseline, Week 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.||units on a scale||Standard Deviation|Mean
749642|NCT00545155|Primary|Concurrent Criterion Validity of Six Item Screener Screening|"This is the Six Item Screener test for cognitive impairment (scoring=yes or no), as compared to performing the Mini-Cog for cognitive impairment (scoring=yes or no) on patients immediately afterwards.
This is concurrent criterion testing (two different instruments, neither being a gold standard) rather than the previous test-retest reliability testing (testing the same instrument twice)."|2 hours|||kappa||95% Confidence Interval|Number
749563|NCT00544557|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 52|BASDAI is a validated self-assessment tool used to determine disease activity in participant with AS. Utilizing a 11-point Likert-scale (0= none and 10=very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The index was computed by adding questions 1 to 4 plus the mean of questions 5 and 6. The resulting 0 to 50 score was divided by 5 to give a final 0–10 BASDAI score (0 being no problem and 10 being the worst problem).|Baseline, Week 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.||units on a scale||Standard Deviation|Mean
749564|NCT00544557|Secondary|Percentage of Participants With Serious Adverse Events (SAEs) or Adverse Events (AEs) by Co-morbidity||Baseline up to Week 52|Safety population included all treated participants with available post­-baseline safety data.||percentage of participants|||Number
749565|NCT00544557|Secondary|Percentage of Participants With Serious Adverse Events (SAEs) or Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life­ threatening experience (immediate risk of dying); persistent or significant disability or incapacity; congenital anomaly. Percentage of participants with AEs included participants affected with both SAEs and non­-SAEs.|Baseline up to Week 52|Safety population included all treated participants with available post-baseline safety data.||percentage of participants|||Number
749566|NCT00544557|Primary|Percentage of Participants Achieving Partial Remission at Week 52|Percentage of participants achieving partial remission was determined by ASAS criteria. Partial remission defined as a score of less than 2 units (on a scale of 0-10, where 0= no disease activity and 10= high disease activity) in each of the 4 assessment in ASAS domains: participant global assessment of disease activity, pain, function, and inflammation.|Week 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, who received etanercept therapy for the first time and had post-baseline documentation. Here ‘N’ signifies participants who were evaluable for this outcome measure.||percentage of participants||95% Confidence Interval|Number
749567|NCT00544557|Primary|Percentage of Participants Achieving Partial Remission at Week 26|Percentage of participants achieving partial remission was determined by assessment of spondyloarthritis international society (ASAS) criteria. Partial remission was defined as a score of less than 2 units (on a scale of 0-10, where 0= no disease activity and 10= high disease activity) in each of the 4 assessment in ASAS domains: participant global assessment of disease activity, pain, function, and inflammation.|Week 26|Effectiveness population: all treated participants greater than or equal to (>=) 18 years of age, with confirmed diagnosis of ankylosing spondylitis, who received etanercept therapy for the first time and had post-baseline documentation. Here ‘N’ (number of participants analyzed) signifies participants who were evaluable for this outcome measure.||percentage of participants||95% Confidence Interval|Number
749568|NCT00544648|Other Pre-specified|Secreted Protein Acidic and Rich in Cysteine (SPARC) Gene Expression|Secreted protein acidic and rich in cysteine (SPARC) gene expression in tumor specimens.|On receipt of tumor tissue blocks|Investigators elected not to perform this analysis.|||||
749569|NCT00544648|Secondary|Response (Phase II)|Number of patients in each response category, per Response Evaluation in Solid Tumors (RECIST) v.1.1: complete response (CR), disappearance of target lesions; partial response (PR) >=30% decrease in sum of longest diameter (LD) of target lesions; progressive disease (PD), >=20% increase in sum of LD of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or PR. Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR>PR>SD>PD.|On-treatment date to date of progressive disease (assessed up to 2 years)|All patients with best overall response data; patients are excluded if best overall response data is missing (n = 0) or if the patient is non-evaluable for best overall response (n = 1)||participants|||Number
749570|NCT00544648|Secondary|Number of Patients With Each Worst Grade Toxicity (Phase II)|The number of patients with worst-grade toxicity at each of five grades following NCI Common Toxicity Criteria: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, disabling, 5 = death|at 16 weeks|Treated patients who experienced a toxicity.||participants|||Number
749571|NCT00544648|Secondary|Overall Survival (Phase II)|Estimated probable duration of life from on-study date to date of death from any cause, using Kaplan-Meier method with censoring (see Analysis Population Description for additional details. Too few patients were enrolled in the Phase II arm for an analysis of overall survival|Time Frame: date on study to date of death from any cause or last known date alive|Too few patients were enrolled in the Phase II arm for an analysis of overall survival|||||
749572|NCT00544648|Secondary|Number of Patients With Each Worst Grade Toxicity (Phase I)|Count of patients according to the worst-grade toxicity (WGT) experienced by each, where worst-grade toxicity is per NCI common toxicity criteria: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening; Grade 5, death.|On-study date to 30 days following final dose of study drug|Total number of patients reported with any toxicity. One patient did not experience toxicity.||participants|||Number
749573|NCT00544648|Secondary|Response (Phase I)|Number of patients in each response category, per Response Evaluation in Solid Tumors (RECIST) v.1.1: complete response (CR), disappearance of target lesions; partial response (PR) >=30% decrease in sum of longest diameter (LD) of target lesions; progressive disease (PD), >=20% increase in sum of LD of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or PR. Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR>PR>SD>PD.|On-treatment date to date of progressive disease (assessed up to 2 years)|All patients with best overall response data; patients are excluded if best overall response data is missing (0) or if the patient is non-evaluable for best overall response (n = 1)||participants|||Number
749643|NCT00545155|Primary|Test-Retest Reliability of Six Item Screener Screening|The Six Item Screener test for cognitive impairment (answer=yes or no)as performed by EMS personnel and study personnel.|2 hours|All of the subjects enrolled who completed follow up and completed all aspects of the testing.||kappa||95% Confidence Interval|Number
749574|NCT00544648|Secondary|Overall Survival (Phase I)|Estimated probable duration of life from on-study date to date of death from any cause, using Kaplan-Meier method with censoring (see Analysis Population Description for additional details).|On-study date to date of death from any cause (assessed up to 2 years)|All patients are included in the analysis on intention-to-treat basis. Analysis is by Kaplan-Meier method, where death is an event, with censoring for non-expired patients at greater of off-study date or last known alive date.||days||95% Confidence Interval|Median
749575|NCT00544648|Secondary|Progression-free Survival (Phase I)|Estimated probable duration of life without disease progression, from on-study date to earlier of progression date, or date of death from any cause, using the Kaplan-Meier method with censoring (see Analysis Population Description for additional details). Disease progression is defined by Response Evaluation in Solid Tumors (RECIST) v.1.1: >= 20% increase in sum of the longest diameter of target lesions, unequivocal progression of non-target lesions, or appearance of new lesions|On-study to lesser of date of progression or date of death from any cause (assessed up to 2 years)|All patients are included in the analysis on intention-to-treat basis. Analysis is by Kaplan-Meier method, where either death or progression is an event, with censoring for non-progressed, non-expired patients at greater of off-study date or last known date alive.||days||95% Confidence Interval|Median
749576|NCT00544648|Primary|Progression-free Survival (Phase II)|Estimated probable duration of life without disease progression, from on-study date to earlier of progression date, or date of death from any cause, using the Kaplan-Meier method with censoring (see Analysis Population Description for additional details). Disease progression is defined by Response Evaluation in Solid Tumors (RECIST) v.1.1: >= 20% increase in sum of the longest diameter of target lesions, unequivocal progression of non-target lesions, or appearance of new lesions|On-study to lesser of date of progression or date of death from any cause (assessed up to 2 years)|All patients are included in the analysis on intention-to-treat basis. Analysis is by Kaplan-Meier method, where either death or progression is an event, with censoring for non-progressed, non-expired patients at greater of off-study date or last known date alive.||days||95% Confidence Interval|Median
749577|NCT00544648|Primary|Maximum Tolerated Dose of Nab-paclitaxel When Combined Concurrently With Carboplatin and Radiation (Phase I)|The highest dose in milligrams per meter of body surface squared (mg/m2) of nab-paclitaxel in combination with carboplatin while maintaining tolerability. Cohorts of 3-6 patients received escalating doses of nab-paclitaxel in combination with carboplatin until the maximum tolerated dose (MTD) was achieved. The MTD is defined as the dose preceding that at which 2 or more of 6 patients experience dose-limiting toxicity (DLT) during the initial cycle of therapy. DLTs per Common Toxicity Criteria v 3.0: recurring non-hematological (except esophagitis) > Grade 2, non-hematological or esophagitis > Grade 3 toxicities that are symptomatically unacceptable to patient and result in treatment delay for > 2 weeks, persistent toxicity resulting in treatment delay for > 2 weeks.|7 weeks|MTD based on clinical performance of those patients who received the study drug. One patient withdrew before receiving treatment. No formal statistical analysis, such as hypothesis testing, was performed.||mg/m2|||Number
749578|NCT00544674|Secondary|Pharmacokinetics||Days 1 and 2 of Cycles 1 and 4||||||
749579|NCT00544674|Primary|Safety and Tolerability: the Number of Subjects Experiencing a Serious Adverse Events|The number of participants with at least one Serious Adverse Event was measured.|30 days following the last administration of study treatment|||participants|||Number
749580|NCT00544674|Secondary|Time to Progression|Time to progression (TTP) was defined as the time from date of registration to radiological progression / recurrence. Subjects without progression at the time of analysis were censored at their last date of tumor evaluation.|From registration of the first subject until radiological progression or recurrence whichever came first||||||
749581|NCT00544674|Secondary|Progression-free Survival|Progression free survival (PFS) is the time (days) from date of registration to date of first observed disease progression (radiological or clinical, whichever was earlier) or death due to any cause, if death occurred before progression was documented.|Tumor measurements and assessments based on Response Evaluation Criteria In Solid Tumors (RECIST) criteria were performed 6 weeks after first dose and as dictated by subject's malignancy||||||
749582|NCT00544674|Secondary|Survival||Every 3 months for 2 years after discontinuation||||||
749583|NCT00544674|Primary|Response Rate (Complete or Partial)||From registration until disease progression/recurrence||||||
749584|NCT00544713|Secondary|Change From Baseline in Study Product Usage at Day 90|Change from baseline in the study product usage (average number of uses per day) at Day 90. A negative number change from baseline indicates a reduction in eye drop usage (improvement).|Baseline, Day 90|Intent-to-Treat includes all patients that started the study and were randomized. Only those patients who reported actual eye drop use at Baseline and on Day 90 were analyzed. This is indicated in parenthesis as (number of patients in arm 1 who reported eye drop use/number of patients in arm 2 who reported eye drop use).||Number of study product uses per day||Standard Deviation|Mean
749585|NCT00544713|Other Pre-specified|Number of Patients Prescribed to Each Dosing Regimen at Day 14 and Day 60|Number of patients prescribed to each dosing regimen at Day 14 and Day 60. At each visit from Day 14 (the first post-operative visit) to Day 60, patients were prescribed to 1 to 4 dosing regimens based on the investigator's clinical evaluation. Dosing schedule options were: At least every 2 hours while awake, 6 to 8 times per day, 3 to 5 times per day, at 1 to 2 times per day.|Day 14, Day 60|Intent to Treat includes all patients that started the study and were randomized. Only those patients who were prescribed a dosing regimen at Day 14 to Day 60 visits were analyzed. The is indicated in parenthesis as (number of patients in arm 1 who were prescribed/number of patients in arm 2 who were prescribed).||Number of patients|||Number
749586|NCT00544713|Secondary|Change From Baseline of the Worse Eye in Tear Break-Up Time (TBUT) at Day 90|Change from Baseline in TBUT of the worse eye at Day 90. TBUT is the time required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A short TBUT is a sign of poor tear film. A positive number change from baseline indicates an increase in TBUT (improvement).|Baseline, Day 90|Intent-to-Treat population defined as all patients who started the study and were randomized||Number of seconds||Standard Deviation|Mean
749644|NCT00545155|Primary|Proportion of Subjects Cognitively Impaired in the ED|Through testing using the Mini-Cog, this measure indicates the proportion of individuals cognitively impaired when tested by study personnel.|Within 2 hours of testing by EMS|All of the subjects enrolled who completed follow up and completed all aspects of the testing.||percentage of subjects|||Number
749587|NCT00544713|Secondary|Change From Baseline of the Worse Eye in Conjunctival Staining With Lissamine Green at Day 90|Change from Baseline in conjunctival staining of the worse eye using Lissamine Green staining procedure. Sum of conjunctival staining over 6 zones; each zone was measured on a modified Oxford Scheme (0 = no staining and 5 = severe staining), with a minimum score of 0 and a maximum score of 30. The higher the grade score, the worse dry eye condition. A negative number change from baseline represents a decrease in corneal staining (improvement).|Baseline, Day 90|Intent-to-Treat population defined as all patients who started the study and were randomized||Scores on a Scale||Standard Deviation|Mean
749588|NCT00544713|Secondary|Change From Baseline of the Worse Eye in Corneal Staining With Fluorescein at Day 90|Change from Baseline in corneal staining of the worse eye at Day 90. Sum of corneal staining over 5 zones; each zone was measured on a modified Oxford Scheme (0 = no staining and 5 = severe staining), for a minimum score of 0 and a maximum score of 25. The higher the grade score, the worse the dry eye condition. A negative change from baseline represents a decrease in corneal staining (improvement).|Baseline, Day 90|Intent to Treat population defined as all patients who started the study and were randomized||Scores on a Scale||Standard Deviation|Mean
749589|NCT00544713|Secondary|Change From Baseline of the Worse Eye in Schirmer's Test at Day 90|Change from baseline in Schirmer's Test results at Day 90 in the worse eye. The Schirmer's Test measures the rate of the secretion of tears produced by the eye over 5 minutes. The results indicate the presence of dry eye (Normal = greater than or equal to 15 millimeters (mm) of tears, Dry Eye = less than 15 mm of tears). The smaller the number, the more severe the dry eye.|Baseline, Day 90|Intent-to-Treat population defined as all patients who started the study and were randomized||Millimeters of Tears||Standard Deviation|Mean
749590|NCT00544713|Secondary|Change From Baseline of Total Higher Order Aberration (HOA) of the Worse Eye at Day 90|Change from Baseline in total HOA of the worse eye. The total HOA number is measured using a machine that calculates and detects changes in the cornea which could occur post Lasik surgery. A negative number change from baseline indicates an improvement.|Baseline, Day 90|Intent-to-Treat population defined as all patients who started the study and were randomized||Microns||Standard Deviation|Mean
749591|NCT00544713|Secondary|Change From Baseline of the Worse Eye in Corneal Topography Measured by Humphrey Atlas at Day 90|Change from Baseline in corneal topography of the worse eye as measured by a Humphrey Atlas system which calculates a number. Corneal topography is anon-invasive medical imaging technique for mapping the surface curvature of the cornea (the outer structure of the eye). The higher the number the more irregular the cornea. A Humphrey Atlas system detects irregular conditions in the cornea with a range from 0 = best to 2.5 = worst. A negative number change from baseline indicates an improvement.|Baseline, Day 90|Intent-to-Treat population defined as all patients who started the study and were randomized||Units on a scale||Standard Deviation|Mean
749592|NCT00544713|Secondary|Change From Baseline of the Worse Eye in Corneal Topography as Measured by Pentacam at Day 90|Change from Baseline in corneal topography of the worse eye as measured using a Pentacam system which calculates a number. Corneal topography is a non-invasive medical imaging technique for mapping the surface of the eye. The Pentacam system measures the pupil and anterior segment (the front part of the eye) which provides a range from 10 (best) to 60 (worst). A negative number change from baseline indicates an improvement.|Baseline, Day 90|Intent-to-Treat population defined as all patients who started the study and were randomized||Units on a scale||Standard Deviation|Mean
749593|NCT00544713|Secondary|Best Corrected Visual Acuity (BCVA) Status at Day 90|"BCVA status at Day 90 reported as the number of patients whose scores were either Better, No Change, or Worse than their scores at baseline. The status was tabulated as number of lines read correctly at Day 90 minus the number of lines read correctly at baseline. Better equals increase of 2 lines or more; No Change equals change between -2 to +2 lines; Worse equals decrease of 2 lines or more. BCVA is measured using a special eye chart a nd is reported as the number of lines (5 letters per line) read correctly."|Day 90|Intent to Treat includes all patients who started the study and were randomized. One patient's status in the first arm was not available at Day 90 and was not evaluated for this outcome measure therefore only 113 patients were analyzed for this outcome measure.||Number of Patients|||Number
749594|NCT00544713|Secondary|Patient Acceptability (Sensory) - Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90|"A patient acceptability - sensory questionnaire was administered to all patients to evaluate the acceptability of the Artificial Tears (AT). Percentage of patients responding either Agree or Strongly Agree at day 90 was tabulated. The potential response categories included Strongly Agree, Agree, Neither Agree Nor Disagree, Disagree and Strongly Disagree."|Day 90|Intent to Treat includes all patients who started the study and were randomized. Only those patients who answered the particular question on Day 90 were analyzed. This is indicated in parenthesis as (number of patients in the first arm who answered that specific question/Number of patients in the second arm who answered that specific question).||Percentage of Patients|||Number
749595|NCT00544713|Secondary|Patient Acceptability- Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90|"A questionnaire was administered to all patients to evaluate the acceptability of the Artificial Tears (referred to as AT). Percentage of patients responding either Agree or Strongly Agree at day 90 was tabulated. The potential response categories included Strongly Agree, Agree, Neither Agree Nor Disagree, Disagree and Strongly Disagree."|Day 90|Intent to Treat includes all patients who started the study are were randomized. Only those patients who answered the particular question on Day 90 were analyzed. This is indicated in parenthesis as (number of patients in the first arm who answered that specific question/Number of patients in the second arm who answered that specific question).||Percentage of Patients|||Number
749596|NCT00544713|Primary|Post LASIK Dry Eye Symptoms as Measured by Ocular Surface Disease Index (OSDI©) Score at Day 90|Measured on 12 domains (categories); a 5-point scale for each domain (0 = best, no dry eye symptoms, 4 = worst, constant dry eye symptoms). Sum of the domain scores is normalized (standardized) to a severity scale of 0-100 (0 = no symptoms (best score), 100 = maximum severity (worst score)).|Day 90|Intent to Treat population defined as all patients who started the study and were randomized||Scores on a Scale||Standard Deviation|Mean
749597|NCT00544778|Primary|Response Rate|Response rate defined as the proportion of subjects with confirmed partial or complete response as defined by the RECIST criteria.|First disease evaluation one month after the start of treatment and every 3 months there after, up to 2 years.|||percentage of patients responding|||Number
763685|NCT00670540|Secondary|Percentage of Participants Who Developed Cardiovascular Events||at 3 years|||percentage of participants||95% Confidence Interval|Number
749598|NCT00544817|Secondary|Objective Response|"The number of patients with complete or partial responses measured from the time of initial response to documented tumor progression. Radiologic response was defined using the Macdonald criteria.
The Macdonald criteria divides response into 4 types of response based on imaging (MRI) and clinical features, as follows: 1) complete response (CR); 2) partial response (PR); 3) stable disease (SD); and 4) progression (PD).
Criteria:
CR: disappearance of all enhancing disease (measurable and non-measurable) sustained for at least 4 weeks, no new lesions. No corticosteroids, clinically stable or improved.
PR: >=50% decrease of all measurable enhancing lesions, sustained for at least 4 weeks, no new lesions. Stable or reduced corticosteroids, clinically stable or improved.
SD: does not qualify for complete response, partial response or progression. Clinically stable.
PD: >= 25% increase in enhancing lesions, any new lesions. Clinical deterioration."|every 8 weeks until disease progression, estimated 18 months|||participants|||Number
749599|NCT00544817|Secondary|Overall Survival|Defined as Day 1 of protocol treatment to date of death from any cause.|18 months|||Months||95% Confidence Interval|Median
749600|NCT00544817|Primary|Progression-free Survival|Defined as the duration of time from start of treatment to time of progression or death, whichever comes first.|18 months|||Months||95% Confidence Interval|Median
749601|NCT00544869|Primary|Body Weight|The change of body weight from baseline at final observation|Baseline, Day 14 or at the time of final drug administration|||Kg||Standard Deviation|Mean
749602|NCT00544882|Secondary|Percentage of Participants With Bleeding During Unscheduled and Scheduled Study Periods|The percentage of participants with unscheduled (Day 1 to Day 21 of each cycle) and scheduled (ie,withdrawal [Day 22 to Day 28 of each cycle]) bleeding (not including spotting) was derived from participant diaries.|Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21|Intent-to-treat||percentage of participants|||Number
749603|NCT00544882|Secondary|Number of Days of Bleeding During Unscheduled and Scheduled Study Periods|The total number of days of unscheduled (Day 1 to Day 21 of each cycle) and scheduled (ie,withdrawal [Day 22 to Day 28 of each cycle]) bleeding (not including spotting) was derived from participant diaries.|Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21|Intent-to-treat||days||Standard Deviation|Mean
749604|NCT00544882|Secondary|Percentage of Participants With Bleeding or Spotting During Unscheduled and Scheduled Study Periods|The percentage of participants with unscheduled (Day 1 to Day 21 of each cycle) and scheduled (ie,withdrawal [Day 22 to Day 28 of each cycle]) bleeding or spotting was derived from participant diaries.|Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21|Intent-to-treat||percentage of participants|||Number
749605|NCT00544882|Secondary|Number of Days of Bleeding or Spotting During Unscheduled and Scheduled Study Periods|The total number of days of unscheduled (Day 1 to Day 21 of each cycle) and scheduled (ie,withdrawal [Day 22 to Day 28 of each cycle]) bleeding or spotting was derived from participant diaries.|Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21|Intent-to-treat||days||Standard Deviation|Mean
749606|NCT00544882|Secondary|Change From Cycle 2 Days 1 - 20 to Cycle 2 Days 21 - 28 in Maximum Follicle Size|The change in the size of the largest documented follicle during combination therapy (Days 1 to 21) and during monotherapy/placebo (Days 21-28) measured by trans-vaginal ultrasound.|Cycle 2, Days 1-20 and Cycle 2, Days 21-28|Intent-to-treat population with available data.||mm||Standard Deviation|Mean
749607|NCT00544882|Primary|Serum Inhibin-B Levels by Cycle Day|Levels of inhibin-B were measured throughout the study from blood samples.|Cycle 2, Day 2 (Baseline), and Days 4, 6, 19-20, 23, 24, 25, 27, 28, Cycle 3, Days 2, 4 and 6.|Intent-to-treat population with available data at each time point (as indicated by n).||pg/mL||Full Range|Median
749608|NCT00544882|Primary|Serum Follicle Stimulating Hormone (FSH) Levels by Cycle Day|Levels of follicle stimulating hormone were measured throughout the study from blood samples.|Cycle 2, Day 2 (Baseline), and Days 4, 6, 19-20, 23, 24, 25, 27, 28, Cycle 3, Days 2, 4 and 6.|Intent-to-treat population with available data at each time point (as indicated by n).||mIU/mL||Full Range|Median
749609|NCT00544882|Secondary|Percentage of Follicles Greater Than 5 mm in Diameter|Ovarian follicles were measured by trans-vaginal ultrasound. The size of the 3 largest follicles was documented for each participant, and the percentage of follicles greater than 5 mm in diameter was calculated based on the total number follicles present (indicated by n for each time point).|Cycle 1, Days 11, 19-20, 23, 25, 27, Cycle 2, Days 4, 11, 19-20, 23, 25, 27, Cycle 3, Day 4.|Intent-to-treat||percentage of follicles|||Number
749610|NCT00544882|Primary|Serum Estradiol Levels by Cycle Day|Levels of estradiol were measured throughout the study from blood samples.|Cycle 2, Day 2 (Baseline), and Days 4, 6, 19-20, 23, 24, 25, 27, 28, Cycle 3, Days 2, 4 and 6.|Intent-to-treat population with available data at each time point (as indicated by n).||pg/mL||Full Range|Median
749611|NCT00544908|Secondary|Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|After every two cycles, up to 5 years|||percentage of participants|||Number
749612|NCT00544908|Primary|Progression-free Survival (PFS) Rate at 4 Months|Progressive disease - appearance of one or more new lesions. Unequivocal progression of existing non-target lesions. Although a clear progression of non-target lesions only is exceptional, in such circumstances, the opinion of the treating physician should prevail and the progression status should be confirmed later on by a review panel (or study chair/primary investigator).|Four months.|||percentage of participants|||Number
749613|NCT00545025|Secondary|Seroconversion Factor for HI Antibodies Against 3 Strains of Influenza Disease.|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 3 influenza strains assessed were A/Solomon Islands (A/SOL), A/Wisconsin (A/WIS) and B/Malaysia (B/MAL).|At Day 21|The analysis was based on the according-to-protocol (ATP) Cohort for immunogenicity, which included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after revaccination.||Fold increase||95% Confidence Interval|Geometric Mean
749614|NCT00545025|Secondary|Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.|A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 3 influenza strains assessed were A/Solomon Islands (A/SOL), A/Wisconsin (A/WIS) and B/Malaysia (B/MAL).|At Day 0 and 21|The analysis was based on the according-to-protocol (ATP) Cohort for immunogenicity, which included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after revaccination.||Subjects|||Number
749615|NCT00545025|Secondary|Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 influenza strains assessed were A/Solomon Islands (A/SOL), A/Wisconsin (A/WIS) and B/Malaysia (B/MAL).|At Day 21|The analysis was based on the according-to-protocol (ATP) Cohort for immunogenicity, which included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after revaccination.||Subjects|||Number
749616|NCT00545025|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/Solomon Islands (A/SOL), A/Wisconsin (A/WIS) and B/Malaysia (B/MAL). The seropositivity cut-off assay was 1:10.|At Days 0 and 21|The analysis was based on the according-to-protocol (ATP) Cohort for immunogenicity, which included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after revaccination.||Titer||95% Confidence Interval|Geometric Mean
749617|NCT00545025|Primary|Number of Subjects With Any and Related Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related = SAE assessed by the investigator as causally related to the study vaccination.|During the entire study period (Days 0-30)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subjects|||Number
749618|NCT00545025|Primary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented normal activity. Related = unsolicited AE assessed by the investigator as causally related to the study vaccination.|During a 30-day (Days 0-29) follow-up period after re-vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subjects|||Number
749619|NCT00545025|Primary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.|Assessed solicited general symptoms were arthralgia, fatigue, fever [oral temperature equal to or above ≥ 37.5 degrees Celsius (°C)], headache, myalgia, nausea and shivering. Any = incidence of a particular symptom regardless of grade intensity or relationship with the study vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0°C. Related = symptom considered by the investigator to have a causal relationship to study vaccination.|During a 7-day (Days 0-6) follow-up after re-vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subjects|||Number
749620|NCT00545025|Primary|Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms|Assessed solicited local symptoms were ecchymosis, pain, redness and swelling at injection site. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal everyday activity. Grade 3 redness/swelling/ecchymosis = redness/swelling/ecchymosis spreading beyond 50 millimeters (mm) of the injection site. All solicited local symptoms assessed were considered by the investigator as related to study vaccination.|During a 7-day (Days 0-6) follow-up period after re-vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subjects|||Number
749621|NCT00545051|Secondary|Percentage of Participants Withdrawn Due to Worsening in BMD at 6 Months and/or Worsening in BMD at Least 7 Percent (%) at Any Site at 6 Months|Worsening in BMD was defined as BMD T-score at any site less than or equal to (≤) - 2.5 standard deviations and/or worsening in BMD of at least 7% at any site.|Month 6|ITT population||percentage of participants|||Number
749622|NCT00545051|Secondary|Percent Change From Baseline in Bone Turnover Markers at Month 1, Month 6 and Month 12|Serum C-terminal Telopeptide of Type 1 Collagen (sCTX), Serum Procollagen Type 1 N-terminal Propeptide (P1NP) and Serum Bone Tartrate-resistant Acid Phosphatase Isoform 5b (TRACP) are measures of bone resorption and are measured as nanograms per milliliter (ng/mL). Percent change from Baseline to Months 1, 6 and 12 was calculated using analysis of covariance for repeated measurements.|Baseline and Months 1, 6 and 12|ITT population; n=number of participants analyzed at the specified visit for the given parameter.||percent change in bone turnover markers||Standard Deviation|Mean
749623|NCT00545051|Secondary|Percent Change From Baseline in Mean Total Hip BMD at Month 6 and Month 12|Left total hip BMD was measured by DXA at Baseline, and Months 6 and 12. If there was prosthesis of left hip, the measurement of right total hip BMD was done by DXA. Percent change from Baseline to Months 6 and 12 was calculated using analysis of (co)variance for repeated measurements.|Baseline and Months 6 and 12|ITT population; number (n) equals (=) number of participants analyzed at the specified visit.||percent change in BMD||Standard Deviation|Mean
749624|NCT00545051|Secondary|Percent Change From Baseline in Mean Lumbar Spine BMD at Month 6|Lumbar spine BMD was measured at Baseline and Month 6 using DXA. Percent change from Baseline to Month 6 was calculated using analysis of covariance.|Baseline and Month 6|ITT Population||percent change in BMD||Standard Deviation|Mean
749625|NCT00545051|Primary|Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at Month 12|Lumbar spine BMD was measured at Baseline, and Months 6 and 12 using dual-energy x-ray absorptiometry (DXA). Percent change from Baseline to Month 12 was calculated using analysis of covariance.|Baseline and Month 12|Intent-to-treat (ITT) population||percent change in BMD||Standard Deviation|Mean
749626|NCT00545064|Other Pre-specified|Change in Intra-ocular Pressure (IOP) for Worse Eye From Baseline to Week 4 and From Baseline to Week 8, in Patients Receiving Preservative-free Dorzolamide-timolol|IOP measurements using Goldmann applanation tonometry, performed by a masked physician two hours after patient was administered study medication. Change is computed as week 4 (or week 8) value minus baseline value.|Baseline to Week 4 and from Baseline to Week 8|176 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. Observations on IOP were available for 164 and 166 patients at week 4 and 8 respectively||mm Hg||Standard Deviation|Mean
750475|NCT00553098|Secondary|Disease Response by 1 Year Post Transplant|Number of patients at 1 year with disease response (defined as no clinical evidence of active disease and/or sufficient level of donor chimerisms to prevent disease recurrence)|1 year|Excludes 9 patients who expired prior to 1 year time point.||Participants|||Count of Participants
749627|NCT00545064|Other Pre-specified|Physician’s Global Satisfaction|At week 8, physicians were asked to complete a single question describing how satisfied they were regarding their patient’s treatment, on a 5-level scale: very satisfied, satisfied, neither satisfied or dissatisfied, dissatisfied, very dissatisfied.|Week 8|178 - number of patients that signed the consent form and received at least one dose of study medication. The number of patients analyzed (n=176) differs from the initial tables because 2 patients withdrew consent and for whom no data were available at subsequent visits (only baseline characteristics were available).||Participants|||Number
749628|NCT00545064|Other Pre-specified|Patient’s Global Satisfaction|At week 8, patients were asked to complete a single question describing how satisfied they were regarding with their medication, on a 5-level scale: very satisfied, satisfied, neither satisfied or dissatisfied, dissatisfied, very dissatisfied.|Week 8|178 - number of patients that signed the consent form and received at least one dose of study medication. The number of patients analyzed (n=176) differs from the initial tables because 2 patients withdrew consent and for whom no data were available at subsequent visits (only baseline characteristics were available).||Participants|||Number
749629|NCT00545064|Primary|Change in Glaucoma Symptom Scale (GSS)-SYMP-6 Score|GSS-SYMP-6 measures 6 non-visual adverse symptoms related to glaucoma medications, with 10 5-point Likert scale questions. Score ranges between 0 and 100, lower scores indicating higher symptoms severity. Change equals post-baseline value minus baseline.|Baseline to week 8|176 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. Observations on GSS-SYMP-6 were available for 114 and 111 patients at week 4 and 8 respectively||Units on a Scale||Standard Deviation|Mean
749630|NCT00545103|Secondary|Percent of Subjects Requiring Surgery for Diverticulitis||up to 104 Weeks|Full Analysis Set||percentage of subjects|||Number
749631|NCT00545103|Secondary|Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Negative|A negative CT scan was defined as a CT scan that did not show bowel wall thickening (>5 mm) and/or fat stranding as read by the central reader.|up to 104 weeks|Suspected Recurrence of Diverticulitis consists of subjects in the Full Analysis Set who had a CT scan performed. Since subjects may have had more than one suspected recurrence, counts are of the number of CT scans, not the number of subjects.||Number of CT Scans|||Number
749632|NCT00545103|Secondary|Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Positive|A positive CT scan was defined as a CT scan that showed bowel wall thickening (>5 mm) and/or fat stranding as read by the central reader.|up to 104 weeks|Suspected Recurrence of Diverticulitis consists of subjects in the Full Analysis Set who had a CT scan performed. Since subjects may have had more than one suspected recurrence, counts are of the number of CT scans, not the number of subjects.||Number of CT Scans|||Number
749633|NCT00545103|Secondary|Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Negative|A negative CT scan was defined as a CT scan that did not show bowel wall thickening (>5 mm) and/or fat stranding as read by the central reader.|up to 104 weeks|Suspected Recurrence of Diverticulitis consists of subjects in the Full Analysis Set who had a CT scan performed. Since subjects may have had more than one suspected recurrence, counts are of the number of CT scans, not the number of subjects.||Number of CT Scans|||Number
749634|NCT00545103|Secondary|Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Positive|A positive CT scan was defined as a CT scan that showed bowel wall thickening (>5 mm) and/or fat stranding as read by the central reader.|up to 104 Weeks|Suspected Recurrence of Diverticulitis consists of subjects in the Full Analysis Set who had a CT scan performed. Since subjects may have had more than one suspected recurrence, counts are of the number of CT scans, not the number of subjects.||Number of CT Scans|||Number
749635|NCT00545103|Secondary|Percent of Subjects Who Are CT-Recurrence Free of Diverticulitis|CT-recurrence of diverticulitis is defined as: a positive spiral CT scan for diverticulitis showing, at a minimum, fat stranding with or without bowel wall thickening >5 mm or surgical intervention for diverticular disease. Withdrawals considered as CT-recurrences.|up to 104 weeks|Full Analysis Set||percentage of subjects|||Number
749636|NCT00545103|Primary|Percent of Subjects Without Recurrence of Diverticulitis|Recurrence of diverticulitis is defined as the presence of each and all of the following 3 items: 1) abdominal pain, 2) a 15% increase in white blood cell count from baseline, 3) bowel wall thickening (>5 mm) and/or fat stranding as evidenced by spiral computerized axial tomography (CT) scan; OR surgical intervention for diverticular disease. Withdrawals are considered as recurrences.|up to 104 Weeks|Full Analysis Set (FAS) consists of all subjects who were randomized and took at least 1 dose of investigational product.||percentage of subjects|||Number
749637|NCT00545155|Primary|Concurrent Criterion Validity of PHQ-2|"This is the PHQ-2, a test for depression (scoring=yes or no) as compared to the PHQ-9, a test for depression (scoring=yes or no), looking at the presence of depression.
This is concurrent criterion testing (two different instruments, neither being a gold standard) rather than the previous test-retest reliability testing (testing the same instrument twice)."|2 hours|||kappa||95% Confidence Interval|Number
749638|NCT00545155|Primary|Test-Retest Reliability Testing of PHQ-2 Screening|The test for depression, using the PHQ-2, with scoring yes or no.|2 hours|||kappa||95% Confidence Interval|Number
749639|NCT00545155|Primary|Proportion of Subjects Depressed in the ED|Through testing using the PHQ-9, this measure indicates the proportion of individuals depressed when tested by study staff in the ED.|Within 2 hours of EMS testing|All of the subjects enrolled who completed follow up and completed all aspects of the testing.||percentage of subjects|||Number
749640|NCT00545155|Primary|Proportion of Subjects Depressed in the ED|Through testing using the PHQ-2, this measure indicates the proportion of individuals depressed when tested by study staff in the ED.|Within 2 hours of EMS testing.|All of the subjects enrolled who completed follow up and completed all aspects of the testing.||percentage of subjects|||Number
749641|NCT00545155|Primary|Proportion of Subjects Depressed in EMS.|Through testing using the Patient Health Questionnaire-2 (PHQ-2), this measure indicates the proportion of individuals depressed when tested by EMS personnel|Upon testing by EMS.|All of the subjects enrolled who completed follow up and completed all aspects of the testing.||percentage of subjects|||Number
749645|NCT00545155|Primary|Proportion of Subjects Cognitively Impaired in the Emergency Department (ED)|Through testing using the Six Item Screener, this measure indicates the proportion of individuals cognitively impaired when tested by study personnel in the ED.|Within 2 hours of testing by EMS.|All of the subjects enrolled who completed all aspects of the testing.||percentage of subjects|||Number
749646|NCT00545155|Primary|Proportion of Subjects Cognitively Impaired in Emergency Medical Services (EMS)|Through testing using the Six Item Screener, this measure indicates the proportion of individuals cognitively impaired when tested by EMS personnel.|Upon testing by EMS.|All of the subjects enrolled who completed follow up and completed all aspects of the testing.||percentage of subjects|||Number
749647|NCT00545168|Primary|Efficacy of NatrOVA Creme Rinse - 1% Relative to NIX Creme Rinse in Subjects Infested With Head Lice|The primary efficacy endpoint was the proportion of primary subjects in the enrolled households who were lice free (no live lice, adults or nymphs), as assessed by the trained evaluator, 14 days after the last treatment (i.e., Day 14 for subjects who treated once and Day 21 for subjects who treated twice).|Assessment were made 14 days following the final product treatment|Primary efficacy analysis was conducted using the Intent to Treat data obtained from primary subjects (i.e., youngest enrolled members of each household who had at least three live lice at the time of entry into the study). Subjects who were lice free 14 days post-treatment were considered successes and all other subjects were considered failures.||participants|||Number
749648|NCT00545168|Secondary|Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions.|To evaluate the safety of NatrOVA® 1% Creme Rinse based upon reported adverse events and observed skin/scalp reactions. Additional safety assessments included cutaneous/ocular irritation.|Participants were followed for a minimum of 14 days (1 treatment) and a maximum of 21 days (2 treatments)|480 subjects were randomized to treatment and 469 subjects used the study drug and returned for at least one post-baseline evaluation. At Day 0 the study drug was to be used within 24 hours. Thus subjects used 1 or 2 treatments.||Incidents|||Number
749649|NCT00545181|Primary|Recurrent Bacterial Vaginosis|Recurrence by either Amsel's or Nugent's criteria. Amsel's criteria are the presence of 3 of 4 of following: 1. homogenous gray-white vaginal discharge, 2. elevated vaginal pH >4.7, 3. presence of at least 20% of vaginal epithelial cells being clue cells on wet prep microscopy, and 4. positive amine odor test on addition of 10% KOH. Nugent's criteria is based on microscopy and bacterial scoring of lactobaccilus, gardnerella, and curved gram-variable rods. A score of at least 7 is indicative of bacterial vaginosis.|3 months|||Participants|||Number
749650|NCT00545233|Secondary|Percentage of Participants With Beck Depression Inventory Fast Screen (BDI-FS) Score ≥ 4 at Each Time Point Assessed|The BDI-FS consisted of seven areas with four statements (labeled 0, 1, 2, and 3) offered to describe the area of interest, with 0 indicating no effect and 3 indicating the worst effect. The individual area scores were summed to provide a total score. The degree of depression was assessed with 0 to 3 indicating minimal depression, 4 to 8 mild depression, 9 to 12 moderate depression and 13 to 21 severe depression.|Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72|Participants from the Safety population who received at least one dose of study drug and who had data available at the given time point for analysis.||Percentage of Participants|||Number
749651|NCT00545233|Secondary|Change From Baseline in Free Fatty Acid Levels at Each Time Point Assessed|"Blood was collected for free fatty acids at various time points throughout the study and was used as a measure of insulin resistance (the inability of insulin to control blood sugar levels).
Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated."|Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72|Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.||mmol/L||Standard Error|Mean
749652|NCT00545233|Secondary|Change From Baseline in Leptin Levels at Each Time Point Assessed|"Blood was collected for leptin at various time points throughout the study and was used as a measure of insulin resistance (the inability of insulin to control blood sugar levels).
Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated."|Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72|Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.||ng/mL||Standard Error|Mean
749653|NCT00545233|Secondary|Change From Baseline in Adiponectin Levels at Each Time Point Assessed|"Blood was collected for adiponectin at various time points throughout the study and was used as a measure of insulin resistance (the inability of insulin to control blood sugar levels).
Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated."|Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72|Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.||μg/mL||Standard Error|Mean
749654|NCT00545233|Secondary|Change From Baseline in Transforming Growth Factor Beta (TGF-β) Levels at Each Time Point Assessed|"Blood was collected for Transforming Growth Factor beta at various time points throughout the study and was used as a measure of insulin resistance (the inability of insulin to control blood sugar levels).
Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated."|Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72|Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.||pg/mL||Standard Error|Mean
749655|NCT00545233|Secondary|Change From Baseline in Tumor Necrosis Factor Alpha (TNF-α) at Each Time Point Assessed|"Blood was collected for tumor necrosis factor alpha at various time points throughout the study and was used as a measure of insulin resistance (the inability of insulin to control blood sugar levels).
Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated."|Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72|Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.||pg/mL||Standard Error|Mean
750540|NCT00545779|Secondary|Percentage of Participants Who Choose a Monthly Reminder to Take Ibandronate in Part B||Visit 0 (<= Day -30)|The ITT population included all participants who received at least one dose of study medication.||percentage of participants|||Number
749656|NCT00545233|Secondary|Change From Baseline in High-density Lipoprotein (HDL-cholesterol) Levels at Each Time-point Assessed|"Blood was collected and assayed for fasting high-density lipoprotein (HDL-cholesterol) levels at various time points throughout the study and was used as an indicator of lipid control.
Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated."|Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48,60,72|Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.||mmol/L||Standard Error|Mean
749657|NCT00545233|Secondary|Change From Baseline in Low-density Lipoprotein (LDL-cholesterol) Levels at Each Time-point Assessed|"Blood was collected and assayed for fasting serum low-density lipoprotein (LDL-cholesterol) levels at various time points throughout the study and was used as an indicator of lipid control.
Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated."|Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48,60,72|Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.||mmol/L||Standard Error|Mean
749658|NCT00545233|Secondary|Change From Baseline in Total Cholesterol Levels at Each Time-point Assessed|"Blood was collected and assayed for fasting serum cholesterol levels at various time points throughout the study and was used as an indicator of lipid control.
Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated."|Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48,60,72|Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.||mmol/L||Standard Error|Mean
749659|NCT00545233|Secondary|Change From Baseline in Serum Triglyceride Concentrations at Each Time-point Assessed|"Blood was collected and assayed for fasting serum triglyceride levels at various time points throughout the study and was used as an indicator of lipid control.
Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated."|Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60, 72|Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.||mmol/L||Standard Error|Mean
749660|NCT00545233|Secondary|Change From Baseline in Homeostasis Model Assessment (HOMA) Scores at Each Time Point Assessed|"Insulin resistance (IR) is calculated using the following formula:
HOMA score = (fasting glucose in mg/dL × fasting insulin in μIU/mL) / 405.
Baseline for with pioglitazone arm occurred prior to the start of 16 week run-in period and for without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the start of anti-HCV therapy is calculated.
A normal patient can have a HOMA score up to 3. A patient with a score of >3 is definitely IR. Patients scoring 2-3 can be IR but other factors may be causing this without being IR."|Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48,60,72|Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.||HOMA Score||Standard Error|Mean
749661|NCT00545233|Secondary|Change From Baseline in Fasting Hemoglobin A1C (HbA1c) Concentrations at Each Time Point Assessed|"Blood was collected for a fasting Hemoglobin A1C level at various time points throughout the study and was used as a measure of glycemic control (monitoring the ability of the patient to maintain normal blood sugar levels).
Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated."|Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48,60,72|Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.||Percent||Standard Error|Mean
749662|NCT00545233|Secondary|Change From Baseline in Fasting Insulin Levels at Each Time Point Assessed.|"Blood was collected for fasting insulin levels at various time points throughout the study and was used as a measure of glycemic control (monitoring the ability of the patient to maintain normal blood sugar levels).
Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated."|Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72|Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.||pmol/L||Standard Error|Mean
749663|NCT00545233|Secondary|Change From Baseline in Fasting Plasma Glucose Levels at Each Time Point Assessed|"Blood was collected for plasma fasting glucose levels at various time points throughout the study and was used as a measure of glycemic control (monitoring the ability of the patient to maintain normal blood sugar levels).
Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated."|Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72|Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.||mmol/L||Standard Error|Mean
749664|NCT00545233|Secondary|Change in Log10 HCV RNA Viral Load at Assessments From Randomization to 16 Weeks of Pioglitazone Pretreatment Run-In Period for the Pioglitazone Arm Only|Serum HCV RNA was collected at randomization and during the pioglitazone run-in period at various time points for the with pioglitazone arm only. The change from randomization to each of these time points was calculated.|Randomization (Week-16),Weeks -12, -8, -4 and 0|Intent-to Treat population includes all randomized patients who received at least one dose of study drug and had at least one post-randomization HCV RNA assessment. Patients with missing HCV RNA values are considered as non-responders.||IU/mL||Standard Error|Mean
750541|NCT00545779|Secondary|Percentage of Participants Who Have Greater Than or Equal to (>=) 80% Compliance With 6 Monthly Doses of Ibandronate in Part B||Up to Month 6|The ITT population included all participants who received at least one dose of study medication.||percentage of participants|||Number
749665|NCT00545233|Secondary|Percentage of Nonresponders During the 48 Week Anti-HCV Treatment Period|Nonresponders are defined as patients who did not achieve undetectable HCV RNA during anti-HCV treatment|Up to 48 Weeks|Intent-to Treat population includes all randomized patients who received at least one dose of study drug and had at least one post-randomization HCV RNA assessment. Patients with missing HCV RNA values are considered as non-responders.||Percentage of Participants|||Number
749666|NCT00545233|Secondary|Percentage of Participants With a Confirmed Virological Breakthrough up to 48 Weeks|Virological breakthrough is a detectable HCV RNA at any time during anti-HCV treatment up to Week 48 after the attainment of undetectable HCV RNA.|Up to 48 Weeks|Intent-to Treat population includes all randomized patients who received at least one dose of study drug and had at least one post-randomization HCV RNA assessment. Patients with missing HCV RNA values are considered as non-responders.||Percentage of Participants|||Number
749667|NCT00545233|Secondary|Percentage of Participants With a Virological Relapse at Week 72 (24 Weeks After the End of Anti-HCV Treatment)|Virologic relapse was defined as the reappearance of HCV-RNA in serum after PEG-INF alpha 2a therapy is discontinued in a patient who was HCV-RNA undetectable at the completion of anti-HCV therapy.|Week 72|Intent-to Treat population includes all randomized patients who received at least one dose of study drug and had at least one post-randomization HCV RNA assessment. Patients with missing HCV RNA values are considered as non-responders.||Percentage of Participants|||Number
749668|NCT00545233|Secondary|Percentage of Participants With a ≥ 2 log10 Decrease in HCV RNA From Initiation of Pegasys Plus Copegus to Weeks 4, 12, 24, 48, 60, 72|Serum samples were collected for HCV RNA. The percentage of participants with a ≥ 2 log10 decrease in HCV RNA from initiation of Pegasys plus Copegus to time point was calculated.|Initiation of Pegasys plus Copegus, Weeks 4, 12, 24, 48, 60, 72|Intent-to Treat population included all randomized patients who received at least one dose of study drug and had at least one post-randomization HCV RNA assessment. Patients with missing HCV RNA values are considered as non-responders.||Percentage of Participants|||Number
749669|NCT00545233|Secondary|Percentage of Participants Achieving Virologic Response|Virologic response was defined as undetectable HCV RNA < 28 IU/mL. Patients with missing HCV RNA values are considered as non-responders.|Weeks 4, 12, 24, 48, 60, 72|Intent-to Treat population includes all randomized patients who received at least one dose of study drug and had at least one post-randomization HCV RNA assessment.||Percentage of Participants|||Number
749670|NCT00545233|Secondary|Change From Initiation of Pegasys Plus Copegus in log10 HCV RNA Viral Load to Week 24 and Week 48 of Anti-HCV Therapy|Serum samples were collected for HCV RNA. The change from Initiation of Pegasys Plus Copegus to Week 24 and Week 48 in HCV RNA titers were calculated. Randomization for the with Pioglitazone arm occurred prior to the 16 week run-in period and randomization for the without Pioglitazone arm occurred prior to the start of anti-HCV treatment.|Initiation of Pegasys Plus Copegus, Week 24 and Week 48 of anti-HCV therapy|Intent-to Treat population includes all randomized patients who received at least one dose of study drug and had at least one post-randomization HCV RNA assessment. Last Observation Carried Forward (LOCF) was used to replace missing data after dropout with the last observed data.||IU/mL||Standard Error|Mean
749671|NCT00545233|Primary|Change From Initiation of Pegasys Plus Copegus in log10 Hepatitis C Virus Ribonucleic Acid (HCV RNA) Viral Load to Week 12 of Anti-HCV Therapy|Serum samples were collected for HCV RNA. The change from initiation of Pegasys plus Copegus to Week 12 in HCV RNA titers were calculated. Randomization for the with Pioglitazone arm occurred prior to the 16 week run-in period and randomization for the without Pioglitazone arm occurred prior to the start of anti-HCV treatment.|Initiation of Pegasys plus Copegus, Week 12 of anti-HCV treatment|Intent-to Treat population includes all randomized patients who received at least one dose of study drug and had at least one post-randomization HCV RNA assessment. Last Observation Carried Forward (LOCF) was used to replace missing data after dropout with the last observed data.||IU/mL||Standard Error|Mean
749672|NCT00545272|Secondary|Number of Participants Using Rescue Medication|Participants recorded the use of rescue medications (salbutamol/albuterol) for treatment of asthma symptoms twice a day in a diary during the 14 days of the treatment period.|Over 14 days|Intent to treat||participants|||Number
749673|NCT00545272|Secondary|Change From Baseline in Morning and Evening Peak Expiratory Flow|The Peak Expiratory Flow (PEF) rate is the maximal rate that a person can exhale during a short maximal expiratory effort after fully inhaling. Participants measured their PEF using a peak flow meter and recorded measurements in a diary every morning and evening during the study, prior to taking study medication. Change from baseline is the difference between the mean baseline PEF recorded during the screening period until the first day of treatment, and the overall mean PEF from Days 1 to 14.|Baseline (recorded during the screening period) and Days 1-14 (treatment period)|"Intent to treat population. The analysis only includes patients with non-missing data, indicated by N."||liters/minute||Standard Deviation|Mean
749674|NCT00545272|Secondary|Time to Peak Forced Expiratory Volume in 1 Second (FEV1) on Day 1 and Day 14|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Time to peak FEV1 is calculated in minutes from the time of inhalation of study drug to the time of the peak FEV1, which is taken as the maximum FEV1 recorded post-dose.|Day 1 and Day 14 measured pre-dose and up to 4 hours post-dose|"The intent-to-treat population (ITT) population consisted of all randomized patients who had a baseline and at least one post-dose FEV1 measurement. The analysis only includes patients with non-missing data, indicated by N."||minutes||Standard Deviation|Mean
749675|NCT00545272|Secondary|Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Between Baseline (Predose) and 4 Hours Post-dose on Day 1|FEV1 was measured on Day 1 pre-dose and up to 4 hours post-dose. The Area Under the Curve (AUC) for FEV1 was analyzed using Analysis of Covariance adjusting for treatment and region with baseline FEV1 as a covariate.|Day 1, pre-dose, 5, 20 and 30 minutes, 1, 2, 3, and 4 hours post-dose.|The intent-to-treat population (ITT) population consisted of all randomized patients who had a baseline and at least one post-dose FEV1 measurement. Observed data only.||liters||Standard Error|Least Squares Mean
749699|NCT00539279|Secondary|Sheehan Disability Scale (SDS)|The SDS is a self-report questionnaire about functioning. There are 3 scored items (Work/School; Social Life; and Family Life/Home Responsibilities), each with response categories from 0 (zero; Not at All) to 10 (Extremely). Thus, the total score ranges from 0 to 30. Higher scores reflect lower (poorer) levels of functioning.|Pre-treatment, post-treatment, and 6-month follow-up|||units on a scale||Standard Deviation|Mean
749676|NCT00545272|Secondary|The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1) on Day 1|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change from baseline to 24 hour post dose trough FEV1 after 1 day of treatment was analyzed using Analysis of Covariance (ANCOVA) adjusting for treatment and region with baseline FEV1 as a covariate.|Day 1 Baseline (prior to first dose) and 24 hours post-dose.|The intent-to-treat population (ITT) population consisted of all randomized patients who had a baseline and at least one post-dose FEV1 measurement. The analysis only includes patients with non-missing data.||liters||Standard Error|Least Squares Mean
749677|NCT00545272|Secondary|Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Between Baseline (Predose) and 4 Hours Post-dose|FEV1 was measured on Day 14 pre-dose and up to 4 hours post-dose. The Area Under the Curve (AUC) for FEV1 was analyzed using Analysis of Covariance adjusting for treatment and region with baseline FEV1 as a covariate.|Day 14, pre-dose, 5, 20 and 30 minutes, 1, 2, 3, and 4 hours post-dose.|The intent-to-treat population (ITT) population consisted of all randomized patients who had a baseline and at least one post-dose FEV1 measurement. Observed data only.||liters||Standard Error|Least Squares Mean
749678|NCT00545272|Primary|The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1)|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change from baseline to 24 hour post dose trough FEV1 after 14 days of treatment was analyzed using Analysis of Covariance (ANCOVA) adjusting for treatment and region with baseline FEV1 as a covariate.|Baseline (prior to first dose) and Day 15 (24 hours after last dose)|The intent-to-treat population (ITT) population consisted of all randomized patients who had a baseline and at least one post-dose FEV1 measurement. The analysis only includes patients with non-missing data.||liters||Standard Error|Least Squares Mean
749679|NCT00545298|Primary|Adverse Events (AEs) and Serious Adverse Events (SAEs)|All reported adverse events, related or unrelated to the study drug.|up to 24 weeks|All enrolled subjects, 4 in total||number of events|||Number
749680|NCT00545298|Primary|Wound Healing|% Re-epithelialization|Week 20|Per protocol. Only one subject met the 20 week time point. All other subjects withdrew early from the study and did not reach the Week 20 time point||% re-epithelialization|||Number
749681|NCT00545363|Secondary|Percent Change From Baseline in CTX Based on Adherence to Ibandronate|Serum CTX, a biochemical marker of bone resorption, was assessed for all participants at baseline and at final visit (Month 6). The sampling was done at the same time of the day each time to overcome the effect of circadian fluctuations. Participants were considered adherent to treatment if they took at least 83% of their assigned medications (5 of the 6 monthly ibandronate tablets) within the -1 to +21 days of their osteoporosis treatment date each month. Participant adherence was assessed by maintaining records of ‘drug dispensed’ and ‘drug returned’ on CRF and participant’s self-report on Visit 2 (Month 3) and final study visit (Month 6). A drug dispensing log was maintained by the investigator. Participants were instructed at the baseline visit and Visit 2 to save and return unused or partially used medication packages on Visit 2 and final study visit, respectively.|Baseline, Month 6|"ITT population. Number of participants analyzed = participants evaluable for this outcome and n represents number of participants analyzed for the specified category."||percent change||95% Confidence Interval|Least Squares Mean
749682|NCT00545363|Secondary|Percentage of Participants With Osteoporosis Patient Perception Survey (OPPS) and Osteoporosis Medical Care Satisfaction Questionnaire (OMSQ) Composite Satisfaction High Score|OPPS: A standardized 6-item satisfaction questionnaire for osteoporosis medical care and treatment received during the study. Individual item score was transformed and converted to a 0 to 100 scale where higher score indicated greater satisfaction. The composite score was the average of individual item scores (transformed) and ranged from 0 to 100, where higher scores indicated greater satisfaction. OMSQ: A standardized 18-item satisfaction questionnaire for osteoporosis medical care, treatment received and blood test and their results during the study. Individual item score was transformed and converted to a 0 to 100 scale where higher score indicated greater satisfaction. The composite score was the average of individual item scores (transformed) and ranged from 0 to 100, where higher scores indicated greater satisfaction.|At Month 6|ITT population. Number of participants analyzed = participants evaluable for this outcome.||percentage of participants|||Number
749683|NCT00545363|Secondary|Percentage of Participants With Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) Composite Satisfaction High Scores|The OPSAT-Q is a validated questionnaire designed to capture satisfaction with bisphosphonate treatment. It comprises four domains: convenience (questions 1 - 6), quality of life (questions 7 and 8), overall satisfaction (questions 9 and 10), and side effects (questions 11 - 16). Satisfaction with treatment was assessed using the OPSAT-Q composite satisfaction score, which was the average of the scores from the four domains of the OPSAT-Q converted to a 0 - 100-point scale. Higher scores indicated greater treatment satisfaction. A score of 80 or more was considered as high score.|At Month 6|ITT population. Number of participants analyzed = participants evaluable for this outcome.||percentage of participants|||Number
749684|NCT00545363|Primary|Percentage of Participants With Adherence to Treatment|Participants were considered adherent to treatment if they took at least 83 percent (%) of their assigned medications (5 of the 6 monthly ibandronate tablets) within the -1 to +21 days of their osteoporosis treatment date each month. Participant adherence was assessed by maintaining records of ‘drug dispensed’ and ‘drug returned’ on case report form (CRF) and participant’s self-report on Visit 2 (Month 3) and final study visit (Month 6). A drug dispensing log was maintained by the investigator. Participants were instructed at the baseline visit and Visit 2 to save and return unused or partially used medication packages on Visit 2 and final study visit, respectively.|Up to 6 months|Intent to treat (ITT) population included all randomized participants. Number of participants analyzed=number of participants evaluable for this outcome.||percentage of participants|||Number
749685|NCT00539110|Secondary|Pharmacokinetics|evaluate the PK of zolpidem following standard dosing practices|2 weeks postburn||||||
749686|NCT00539110|Primary|Polysomnography Data|Determine if intervention product elicits more total sleep time|2 weeks postburn|||minutes||Standard Error|Mean
749770|NCT00545571|Secondary|Percentage of Participants Who Received Blood Transfusions During the DTP and LTSP|The number of participants who received blood transfusion during the DTP (Weeks 0 and 16) and LTSP (Weeks 18 to 52) was reported.|From Week 0 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52|ITT Population.||percentage of participants|||Number
749687|NCT00539188|Secondary|Hamilton Depression Rating Scale (HAM-D) at Baseline|"The Hamilton Rating Scale for Depression is a multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery. Administered by a clinician, The questionnaire is designed for adults and is used to rate the severity of the patients depression by asking their mood, feelings of guilt, insomnia, agitation, weight change, suicidal ideation, and somatic symptoms. The scale also allows the clinician to assess the patient's level of retardation, and insight into their depression. Highest possible score is 52.
HAM-D Scoring 0-7 = Normal 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severed Depression
≥23 = Very Severe Depression
In this study, Baseline ratings were compared to those of week 6 to assess each participants change in depression throughout the study. A negative value indicates an increase in depression (i.e. the individual felt more depressed) and a positive value indicates a decrease in depression."|Baseline|||units on a scale|||Number
749688|NCT00539188|Primary|Self-Harm Inventory (SHI) Score at Baseline|"The Self-Harm Inventory is assessed by asking an individual to answer (yes or no) if they have ever intentionally, or on purpose tried to harm themselves. The inventory contains 22 questions and a 23rd marked other that allows the individual to indicate a self-harm behavior not previously mentioned.
The scoring of this instrument is determined by counting the number of endorsed self-harm behaviors out of the possible twenty-three asked. The maximum score any individual may achieve for the SHI is a 23. Any individual scoring 5 or greater is classified as suffering from BPD.
In this study, scoring on the SHI was primarily used to assess improvement of self-harming symptoms and throughout the study by comparing participant ratings from baseline and week 6. Positive numbers indicate a decrease (i.e. participant indicated less self-harming behavior) and negative numbers indicate an increase in self-harming behaviors reported."|Baseline|||units on a scale|||Number
749689|NCT00539188|Secondary|Hamilton Depression Rating Scale (HAM-D) at 6 Weeks|"The Hamilton Rating Scale for Depression is a multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery. Administered by a clinician, The questionnaire is designed for adults and is used to rate the severity of the patients depression by asking their mood, feelings of guilt, insomnia, agitation, weight change, suicidal ideation, and somatic symptoms. The scale also allows the clinician to assess the patient’s level of retardation, and insight into their depression. Highest possible score is 52.
HAM-D Scoring 0-7 = Normal 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severed Depression
≥23 = Very Severe Depression
In this study, Baseline ratings were compared to those of week 6 to assess each participants change in depression throughout the study. A negative value indicates an increase in depression (i.e. the individual felt more depressed) and a positive value indicates a decrease in depression."|6 weeks|||units on a scale|||Number
749690|NCT00539188|Primary|Self-Harm Inventory (SHI) Score at 6 Weeks|"The Self-Harm Inventory is assessed by asking an individual to answer (yes or no) if they have ever “intentionally, or on purpose” tried to harm themselves. The inventory contains 22 questions and a 23rd marked other that allows the individual to indicate a self-harm behavior not previously mentioned.
The scoring of this instrument is determined by counting the number of endorsed self-harm behaviors out of the possible twenty-three asked. The maximum score any individual may achieve for the SHI is a 23. Any individual scoring 5 or greater is classified as suffering from BPD.
In this study, scoring on the SHI was primarily used to assess improvement of self-harming symptoms and throughout the study by comparing participant ratings from baseline and week 6. Positive numbers indicate a decrease (i.e. participant indicated less self-harming behavior) and negative numbers indicate an increase in self-harming behaviors reported."|6 weeks|||units on a scale|||Number
749691|NCT00539240|Primary|Acid Regurgitation, Number of Days in Week Symptoms Intensity Score < 3 (Better)|the number of days with Symptom Intensity Score < 3 (better) for acid regurgitation during week 6 as compared to baseline|Symptom control after 6 weeks of treatment|ITT||days||Standard Deviation|Mean
749692|NCT00539240|Primary|Nighttime Heartburn, Number of Days in Week Symptom Activity Score <3 (Better) in Week 6 Compared to Baseline|the number of days with Symptom Intensity Score < 3 (better) for nighttime heartburn during week 6 as compared to baseline|Symptom control after 6 weeks of treatment|ITT||days||Standard Deviation|Mean
749693|NCT00539240|Secondary|Health Related Quality of Life|SF-36 Physical Component Score (higher number better quality of life), is a measure of overall physical quality of life distinct from mental health. The range is 0 - 100. It has been adjusted to US national norms so that a score of 50 corresponds to the national mean.|end of study|ITT||units on a scale||Standard Deviation|Mean
749694|NCT00539240|Primary|Daytime Heartburn, Number of Days in Week Symptoms Intensity Score < 3 (Better)|the number of days with Symptom Intensity Score < 3 (better) for daytime heartburn during week 6 as compared to baseline|Symptom control after 6 weeks of treatment|intention to treat (ITT)||days||Standard Deviation|Mean
749695|NCT00539253|Primary|Nodule Enhancement|Percent area of nodule with enhancement|3 month|Number of participants analyzed reflects the number of participants for whom data was available||percent enhancement||Standard Deviation|Mean
749696|NCT00539253|Primary|Nodule Size|Maximal nodule size measured in centimeters|3 months|The number of participants analyzed reflects the number of participants for whom data was available.||centimeters||Standard Deviation|Mean
749697|NCT00539279|Primary|Clinician-Administered PTSD Scale Severity Score (CAPS)|The CAPS is a clinician-administered interview about PTSD symptoms. There are 17 scored items for PTSD severity, each with response categories from 0 (zero) to 4 separately for both frequency and severity. Thus, each item can receive a score of 0 (zero) to 8, and the total severity score ranges from 0 to 136. Higher scores reflect higher levels of PTSD symptoms. Scores of 60 or above are generally considered clinically significant, and changes of 10 points or more (e.g., between pre-treatment and post-treatment) are considered clinically significant changes.|Pre-treatment, post-treatment, and 6-month follow-up|||units on a scale||Standard Deviation|Mean
749698|NCT00539279|Secondary|Global Neuropsychological Deficits (Standardized, Composite)|Among our battery of seven neuropsychological tests, we worked with our neuropsychologist to choose 13 key scales. We used a conversion system to equally weight areas where there were large deficits, even if there were only one or two deficits, to prevent such scores from being minimized among the large range of T scores for the other scales. We converted T scores as follows: >40 = 0; 35-39 = 1; 30-34 = 2; 25-29 = 3; 20-24 = 4; < 20 = 5. Higher scores mean a higher global cognitive deficit.|Pre-treatment, post-treatment|||standardized units on a scale||Standard Deviation|Mean
757492|NCT00608491|Secondary|Change in Blood Sodium Level||Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mEq/L||Standard Deviation|Mean
749700|NCT00539279|Primary|Patient Health Questionnaire Depression Subscale (PHQ-9)|"The PHQ-9 is a self-report questionnaire about depressive symptoms. There are 9 scored items, each with response categories from 0 (zero) to 3. Thus, the total score ranges from 0 to 27. Higher scores reflect higher levels of depressive symptoms, with interpretation as follows:
0 (zero) No depression 1-4 Minimal depression 5-9 Mild depression 10-14 Moderate depression 15-19 Moderately severe depression 20-27 Severe depression"|Pre-treatment, post-treatment, and 6-month follow-up|||units on a scale||Standard Deviation|Mean
749701|NCT00539279|Secondary|State-Trait Anxiety Inventory State Scale (STAI-S)|"The STAI-S is a self-report questionnaire about state (present state) anxiety. There are 20 scored items, each with response categories from 1 (Not at All) to 4 (Very Much So). Some items (e.g., I feel calm) are reversed scored so that the total score appropriately reflects state anxiety. Thus, the total score ranges from 20 to 80. Higher scores reflect higher levels of state anxiety."|Pre-treatment, post-treatment, and 6-month follow-up|||units on a scale||Standard Deviation|Mean
749702|NCT00539279|Secondary|Posttraumatic Cognitions Inventory (PTCI)|The PTCI is a self-report questionnaire about thoughts following traumatic events. There are 33 scored items, each with response categories from 1 (Totally Disagree) to 7 (Totally Agree), summed to create the total score. Thus, the total score ranges from 7 to 231. Higher scores reflect higher levels of negative cognitions.|Pre-treatment, post-treatment, and 6-month follow-up|||units on a scale||Standard Deviation|Mean
749703|NCT00539279|Primary|PTSD Checklist (PCL)|The PTSD Checklist is a self-report questionnaire about PTSD symptoms. The version used in this study is called the PCL-S, which denotes a specific traumatic event for subjects to respond to. There are 17 items, each with response categories from 1 to 5. Thus, the total score ranges from 17 to 85. Higher scores reflect higher levels of PTSD symptoms, and a score of 50 or above is commonly interpreted to designate clinically significant PTSD symptoms.|Pre-treatment, post-treatment, and 6-month follow-up|||units on a scale||Standard Deviation|Median
749704|NCT00539305|Primary|Short-Form Health Survey (SF-36)|Self assessment of Physical Functioning in Health Survey. Higher scores indicate a higher level of functioning (range 0-100). Month 3 and 6 values represent change from baseline in subscale.|Baseline, Month 3, Month 6|||units on a scale||Standard Deviation|Mean
749705|NCT00539305|Primary|Geriatric Depression Scale (GDS)|Values represent self evaluation of depression (range 0-30). Higher scores indicate a more depressed mood. Month 3 and Month 6 indicate change from baseline.|Baseline, Month 3, Month 6|||units on a scale||Standard Deviation|Mean
749706|NCT00539305|Primary|Cognitive Changes Measured by Neuropsychological Tests: Rey Auditory Verbal Learning Test|Values represent total score in Long Delay Word List Recall. Higher score indicates higher level of functioning (range 0-15). Month 3 and Month 6 indicate change from baseline.|Baseline, 3 and 6 months|||units on a scale||Standard Deviation|Mean
749707|NCT00539305|Primary|Behavioral & Mood Measure: Profile of Mood States (POMS)|Values represent self evaluation of vigor-activity. The scale compares t-scores of participants to published norms (range 0-100), and higher scores indicate elevated emotion in subscale. Higher t-scores in vigor-activity subscale are considered favorable. Month 3 and Month 6 values display change from baseline.|Baseline, 3 and 6 months|Vigor-Activity||units on a scale||Standard Deviation|Mean
749708|NCT00539513|Secondary|The Hamilton Depression Inventory (HAM-D)at 12 Weeks|"The Hamilton Rating Scale for Depression is a multiple item (traditionally 17) assessment used to provide an indication of depression and as a guide to evaluate recovery. The clinician-rated assessment is designed for adults and is used to rate the severity of patient depression by asking about mood, feelings of guilt, insomnia, agitation, weight change, suicidal ideation, and somatic symptoms. The scale also allows the clinician to assess the patient's level of retardation, and insight into their depression.
In this study, the HAM-D17 (17 items scored) was used to obtain depression severity ratings with a maximum possible score of 52. Baseline ratings are compared to those of week 12 to produce a percentage of change, where positive values indicate a decrease in depressive severity/symptoms. Maximum score is a 52.
Ranges
0-7 = Normal 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severe Depression
≥23 = Very Severe Depression"|12 weeks|Participants that completed the study were analyzed||units on a scale||Standard Deviation|Mean
749709|NCT00539513|Primary|Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)at 12 Weeks|"The Y-BOCS is a 10 item clinician-rated scale used to both determine the severity of OCD and to monitor symptom improvement throughout the course of the study. The Y-BOCS, specifically measures the severity of symptoms of obsessive-compulsive disorder without being biased towards the type of obsessions or compulsions present. The scale includes questions about the amount of time spent on, how much impairment or distress experienced from, and how much resistance and control over these obsessive thoughts and compulsions.
Each item is rated from 0 (no symptoms) to 4 (extreme symptoms) and yields a total possible score range from 0 to 40, with the following ranges indicating degree of severity:
0-7 = sub-clinical 8-15 = mild 16-23 = moderate 24-31 = severe 32-40 = extreme
In this study, baseline ratings are compared to those of week 12 to produce a percent of change with positive percentages indicating a decrease in symptom severity."|12 Weeks|Participants who completed the intervention were included in the analysis||units on a scale||Standard Deviation|Mean
749710|NCT00539513|Secondary|The Hamilton Depression Inventory (HAM-D)at Baseline|"The Hamilton Rating Scale for Depression is a multiple item (traditionally 17) assessment used to provide an indication of depression and as a guide to evaluate recovery. The clinician-rated assessment is designed for adults and is used to rate the severity of patient depression by asking about mood, feelings of guilt, insomnia, agitation, weight change, suicidal ideation, and somatic symptoms. The scale also allows the clinician to assess the patient’s level of retardation, and insight into their depression.
In this study, the HAM-D17 (17 items scored) was used to obtain depression severity ratings with a maximum possible score of 52. Baseline ratings are compared to those of week 12 to produce a percentage of change, where positive values indicate a decrease in depressive severity/symptoms. Maximum score is a 52.
Ranges
0-7 = Normal 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severe Depression
≥23 = Very Severe Depression"|Baseline|Participants that completed the study were analyzed||units on a scale||Standard Deviation|Mean
749767|NCT00545441|Primary|Healing Success|Healing was defined as “closure of external opening with absence of abscess, drainage and pain.”|12 months|Patients that were lost to follow-up, withdrew, or not treated were not included in the analysis. In the Surgisis arm, there were 9 patients lost to follow-up, 1 patient withdrew, and 1 patient not treated; in the Flap arm, there were 5 patients lost to follow-up, 1 patient withdrew, and 3 patients not treated.||participants|||Number
749711|NCT00539513|Primary|Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)at Baseline|"The Y-BOCS is a 10 item clinician-rated scale used to both determine the severity of OCD and to monitor symptom improvement throughout the course of the study. The Y-BOCS, specifically measures the severity of symptoms of obsessive–compulsive disorder without being biased towards the type of obsessions or compulsions present. The scale includes questions about the amount of time spent on, how much impairment or distress experienced from, and how much resistance and control over these obsessive thoughts and compulsions.
Each item is rated from 0 (no symptoms) to 4 (extreme symptoms) and yields a total possible score range from 0 to 40, with the following ranges indicating degree of severity:
0–7 = sub-clinical 8–15 = mild 16–23 = moderate 24–31 = severe 32–40 = extreme
In this study, baseline ratings are compared to those of week 12 to produce a percent of change with positive percentages indicating a decrease in symptom severity."|Baseline|Participants who completed the intervention were included in the analysis||units on a scale||Standard Deviation|Mean
749712|NCT00539526|Secondary|Change From Baseline in Tear Break-Up Time (TBUT) at Month 3|Change from baseline in TBUT at month 3. TBUT is defined as the time (seconds) required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A positive number change from baseline indicates improvement.|Baseline, Month 3|||Seconds||Standard Error|Mean
749713|NCT00539526|Secondary|Change From Baseline in Corneal Staining With Fluorescein at Month 3|Change from baseline in corneal staining with fluorescein at month 3. The cornea is the transparent front part of the eye which covers the iris and pupil. To detect the presence or absence of corneal puncta (tiny disruptions in the surface of the eye), fluorescein dye is administered into the eye and the eye is graded using a 5-point scale where 0 equals no puncta (best), and 3 equals too many puncta to count (worst). A negative number change from baseline indicates improvement.|Baseline, Month 3|||Scores on a Scale||Standard Error|Mean
749714|NCT00539526|Primary|Change From Baseline in Mean Conjunctival Hyperemia Scores at Month 3|Change from baseline in mean conjunctival hyperemia scores at month 3. Hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). Hyperemia was graded using a 5-point scale in which 0=no redness and +3=deep, diffuse redness. A negative number change from baseline indicates improvement.|Baseline, Month 3|||Scores on Scale||Standard Error|Mean
749715|NCT00539539|Secondary|Ventilation Rate|Average ventilation rate (breaths/minute) during the first ten minutes of CPR.|Up to 10 minutes of CPR|Intention to treat. Ventilation rate available in 347 participants on the feedback on arm and 346 on the feedback off arm.||breaths per minute||Standard Error|Mean
749716|NCT00539539|Secondary|Percentage of Compressions With an Incomplete Release|Percentage of compressions with incomplete release during the first ten minutes of CPR.|Up to 10 minutes of CPR|Intention to treat. Incomplete release available for 529 participants on the feedback on arm and 467 on the feedback off arm.||% of compressions w/ incomplete release||Standard Error|Mean
749717|NCT00539539|Secondary|Compression Rate|Average compression rate during the first 10 minutes of CPR.|Up to 10 minutes of CPR|Intention to treat. Average compression rate available for 604 participants on the feedback on arm and 570 on the feedback off arm.||Compressions per minute||Standard Error|Mean
749718|NCT00539539|Secondary|Compression Depth|Average compression depth (mm) during the first 10 minutes of CPR.|Up to 10 minutes of CPR|Intention to treat. Compression depth available for 529 participants on the feedback on arm and 467 on the feedback off arm.||mm||Standard Error|Mean
749719|NCT00539539|Secondary|CPR Fraction|Percentage of time during CPR spend doing compressions.|Up to 10 minutes of CPR|Intention to treat, with CPR fraction available for 604 participants on the feedback on arm, and 570 on the feedback off arm.||Percentage||Standard Error|Mean
749720|NCT00539539|Secondary|Survival to Hospital Discharge|Survival to hospital discharge|Length of Hospitalization|Intention to treat, with survival to hospital discharge missing for one participant on the feedback off arm. Analysis included 815 participants on the feedback on arm, and 770 on the feedback off arm.||Participants|||Number
749721|NCT00539539|Secondary|Pulses Present at ED Arrival.||Resuscitation|Intention to treat. Presence of pulses not known for one participant on the feedback off arm. Analysis includes 815 participants on the feedback on arm and 770 on the feedback off arm.||Participants|||Number
749722|NCT00539539|Primary|Rate of ROSC During the Prehospital Resuscitation|Return of spontaneous circulation (ROSC)|Prehospital resuscitation|Intent to treat||Participants|||Number
749723|NCT00539591|Other Pre-specified|BRIEF Psychological Assessment (Stratum B)|The Behavioral Rating Inventory of Executive Function (BRIEF) was administered to parents, assessing for any effects on behavior or mood in children undergoing study therapy. The global executive composite (GEC) T-score (range 0-100) is reported for the BRIEF assessment. Higher scores reflect poorer executive function.|Pretherapy, Week 4, Week 24, End of Therapy, and 6 Months Post End of Therapy|Only one patient had evaluable data in Stratum B, but scores were not available for this instrument due to the age of the patient.|||||
749724|NCT00539591|Other Pre-specified|BRIEF Psychological Assessment (Stratum A)|The Behavioral Rating Inventory of Executive Function (BRIEF) was administered to parents, assessing for any effects on behavior or mood in children undergoing study therapy. The global executive composite (GEC) T-score (range 0-100) is reported for the BRIEF assessment. Higher scores reflect poorer executive function.|Pretherapy, Week 4, Week 24, End of Therapy, and 6 Months Post End of Therapy|This QOL analysis included patients only within Stratum A.||T score||Standard Deviation|Mean
749725|NCT00539591|Other Pre-specified|BASC-2 Psychological Assessment (Stratum B)|The Behavioral Assessment System for Children, 2nd Edition (BASC-2) was administered to parents, assessing for any effects on behavior or mood in children undergoing study therapy. The behavior system index (BSI) T-score (range 0-100) is reported for the BASC-2 assessment. Higher scores reflect greater behavioral problems.|Pretherapy, Week 4, Week 24, End of Therapy, and 6 Months Post End of Therapy|Only one patient had evaluable data in Stratum B, but scores were not available for this instrument due to the age of the patient.|||||
749726|NCT00539591|Other Pre-specified|BASC-2 Psychological Assessment (Stratum A)|The Behavioral Assessment System for Children, 2nd Edition (BASC-2) was administered to parents, assessing for any effects on behavior or mood in children undergoing study therapy. The behavior system index (BSI) T-score (range 0-100) is reported for the BASC-2 assessment. Higher scores reflect greater behavioral problems.|Pretherapy, Week 4, Week 24, End of Therapy, and 6 Months Post End of Therapy|This QOL analysis included patients only within Stratum A.||T score||Standard Deviation|Mean
749727|NCT00539591|Other Pre-specified|Mean Total PedsQL 3.0 Scores for Parent Cancer Quality of Life (QoL) Assessments (Stratum B)|QoL assessments were completed using Pediatrics Cancer Quality of Life Inventory (PedsQL v3.0). Scale range is 0-100 with higher scores reflecting better quality of life.|Weeks 2, 4, 8, 12, and 24; and End of therapy at 6 months and 12 months post|PedsQL v3.0 was not completed pretherapy. Only one patient had evaluable data in Stratum B. The raw score, rather than the mean +/- SD, is presented. Data was not collected after Week 4.||units on a scale|||Number
749728|NCT00539591|Other Pre-specified|Mean Total PedsQL 3.0 Scores for Parent Cancer Quality of Life (QoL) Assessments (Stratum A)|QoL assessments were completed using Pediatrics Cancer Quality of Life Inventory (PedsQL v3.0). Scale range is 0-100 with higher scores reflecting better quality of life.|Weeks 2, 4, 8, 12, and 24; and End of therapy at 6 months and 12 months post|PedsQL v3.0 was not completed pretherapy. This QOL analysis included patients only within Stratum A.||units on a scale||Standard Deviation|Mean
749729|NCT00539591|Other Pre-specified|Mean Total PedsQL 3.0 Scores for Child Cancer Quality of Life (QoL) Assessments (Stratum B)|QoL assessments were completed using Pediatrics Cancer Quality of Life Inventory (PedsQL v3.0). Scale range is 0-100 with higher scores reflecting better quality of life.|Weeks 2, 4, 8, 12, and 24; and End of therapy at 6 months and 12 months post|PedsQL v3.0 was not completed pretherapy. Only one patient had evaluable data in Stratum B. The raw score, rather than the mean +/- SD, is presented. Data was not collected at Week 24, and the patient was taken off study prior to 6 months after end of therapy.||units on a scale|||Number
749730|NCT00539591|Other Pre-specified|Mean Total PedsQL 3.0 Scores for Child Cancer Quality of Life (QoL) Assessments (Stratum A)|QoL assessments were completed using Pediatrics Cancer Quality of Life Inventory (PedsQL v3.0). Scale range is 0-100 with higher scores reflecting better quality of life.|Weeks 2, 4, 8, 12, and 24; and End of therapy at 6 months and 12 months post|PedsQL v3.0 was not completed pretherapy. This QOL analysis included patients only within Stratum A.||units on a scale||Standard Deviation|Mean
749731|NCT00539591|Other Pre-specified|Mean Total PedsQL 4.0 Scores for Parent Quality of Life Assessments (Stratum B)|QoL assessments were completed using Pediatrics Quality of Live Inventory (PedsQL v4.0). Scale range is 0-100 with higher scores reflecting better quality of life. PedsQL 4.0 healthy sample normative mean ± SD for parent report = 87.6 ± 12.3.|Pretherapy; Weeks 2, 4, 8, 12, and 24; and End of therapy at 6 months and 12 months post|Only one patient had evaluable data in Stratum B. The raw score, rather than the mean +/- SD, is presented. Data was not collected after Week 4.||units on a scale|||Number
749732|NCT00539591|Other Pre-specified|Mean Total PedsQL 4.0 Scores for Parent Quality of Life Assessments (Stratum A)|QoL assessments were completed using Pediatrics Quality of Live Inventory (PedsQL v4.0). Scale range is 0-100 with higher scores reflecting better quality of life. PedsQL 4.0 healthy sample normative mean ± SD for parent report = 87.6 ± 12.3.|Pretherapy; Weeks 2, 4, 8, 12, and 24; and End of therapy at 6 months and 12 months post|This QOL analysis included patients only within Stratum A.||units on a scale||Standard Deviation|Mean
749733|NCT00539591|Other Pre-specified|Mean Total PedsQL 4.0 Scores for Child Quality of Life (QoL) Assessments (Stratum B)|QoL assessments were completed using Pediatrics Quality of Life Inventory (PedsQL v4.0). Scale range is 0-100 with higher scores reflecting better quality of life. PedsQL 4.0 healthy sample normative mean ± SD for child report = 83.0 ± 14.8.|Pretherapy; Weeks 2, 4, 8, 12, and 24; and End of therapy at 6 months and 12 months post|Only one patient had evaluable data in Stratum B. The raw score, rather than the mean +/- SD, is presented. Data was not collected at Week 24, and the patient was taken off study prior to 6 months after end of therapy.||units on a scale|||Number
749734|NCT00539591|Other Pre-specified|Mean Total PedsQL 4.0 Scores for Child Quality of Life (QoL) Assessments (Stratum A)|QoL assessments were completed using Pediatrics Quality of Life Inventory (PedsQL v4.0). Scale range is 0-100 with higher scores reflecting better quality of life. PedsQL 4.0 healthy sample normative mean ± SD for child report = 83.0 ± 14.8.|Pretherapy; Weeks 2, 4, 8, 12, and 24; and End of therapy at 6 months and 12 months post|This QOL analysis included patients only within Stratum A.||units on a scale||Standard Deviation|Mean
749735|NCT00539591|Other Pre-specified|Systemic Clearance (CL) of Interferon ɑ-2B|Samples were analyzed for interferon ɑ-2b concentrations by using the VeriKine Human Interferon Alpha ELISA Kit following the manufacturer's instructions, and concentration-time data were analyzed by nonlinear-mixed effects modeling as implemented in NONMEM.|Before first dose, and 1, 2, 4, 6, 8, 12, and 24 hours postinfusion|The pharmacokinetic (PK) analysis of pegylated ɑ-2b included only patients within Stratum A who had PK studies performed. Only one patient had evaluable data in Stratum B and is not included in the final analysis due to differences in clinical variables.||l/hr/m^2||Full Range|Median
749736|NCT00539591|Other Pre-specified|Volume of Central Compartment (Vc) of Interferon ɑ-2b|Samples were analyzed for interferon ɑ-2b concentrations by using the VeriKine Human Interferon Alpha ELISA Kit following the manufacturer's instructions, and concentration-time data were analyzed by nonlinear-mixed effects modeling as implemented in NONMEM.|Before first dose, and 1, 2, 4, 6, 8, 12, and 24 hours postinfusion|The pharmacokinetic (PK) analysis of pegylated ɑ-2b included only patients within Stratum A who had PK studies performed. Only one patient had evaluable data in Stratum B and is not included in the final analysis due to differences in clinical variables.||l/m^2||Full Range|Median
749737|NCT00539591|Other Pre-specified|Half-Life of Interferon ɑ-2b|Samples were analyzed for interferon ɑ-2b concentrations by using the VeriKine Human Interferon Alpha ELISA Kit following the manufacturer's instructions, and concentration-time data were analyzed by nonlinear-mixed effects modeling as implemented in NONMEM.|Before first dose, and 1, 2, 4, 6, 8, 12, and 24 hours postinfusion|The pharmacokinetic (PK) analysis of pegylated ɑ-2b included only patients within Stratum A who had PK studies performed. Only one patient had evaluable data in Stratum B and is not included in the final analysis due to differences in clinical variables.||hours||Full Range|Median
749738|NCT00539591|Other Pre-specified|Area Under the Curve (AUC) of Interferon ɑ-2b|Samples were analyzed for interferon ɑ-2b concentrations by using the VeriKine Human Interferon Alpha ELISA Kit following the manufacturer's instructions, and concentration-time data were analyzed by nonlinear-mixed effects modeling as implemented in NONMEM. AUC is given as Time 0 to infinity.|Before first dose, and 1, 2, 4, 6, 8, 12, and 24 hours postinfusion|The pharmacokinetic(PK) analysis of pegylated ɑ-2b included only patients within Stratum A who had PK studies performed. Only one patient had evaluable data in Stratum B and is not included in the final analysis due to differences in clinical variables.||pcg * hr/ml||Full Range|Median
749739|NCT00539591|Other Pre-specified|Apparent Clearance (CL) of Pegylated Interferon ɑ-2B|"Pharmacokinetic (PK) analysis of pegylated ɑ-2b included only Stratum A patients who had PK studies performed.
Samples were analyzed for pegylated interferon ɑ-2b concentrations by using the VeriKine Human Interferon Alpha ELISA Kit following the manufacturer's instructions, and concentration-time data were analyzed by nonlinear-mixed effects modeling as implemented in NONMEM."|Before first dose, and 24, 96 and 168 hours after dose during weeks 5 and 28|Only one Stratum B patient had evaluable data and is not included in final analysis due to differences in clinical variables, because data from more than one patient are required for nonlinear-mixed effects modeling. Two patients in Week 5 and three in Week 28 were excluded due to inadequate sampling to characterize an AUC value.||ml/hr/kg||Full Range|Median
749740|NCT00539591|Other Pre-specified|Volume of Central Compartment (Vc) of Pegylated Interferon ɑ-2B|"Pharmacokinetic (PK) analysis of pegylated ɑ-2b included only Stratum A patients who had PK studies performed.
Samples were analyzed for pegylated interferon ɑ-2b concentrations by using the VeriKine Human Interferon Alpha ELISA Kit following the manufacturer's instructions, and concentration-time data were analyzed by nonlinear-mixed effects modeling as implemented in NONMEM."|Before first dose, and 24, 96 and 168 hours after dose during weeks 5 and 28|Only one Stratum B patient had evaluable data and is not included in final analysis, because data from more than one patient are required for nonlinear-mixed effects modeling due to differences in clinical variables. Two patients in Week 5 and three in Week 28 were excluded due to inadequate sampling to characterize an AUC value.||ml/kg||Full Range|Median
749741|NCT00539591|Other Pre-specified|ɑ Half Life of Pegylated Interferon ɑ-2B|"Pharmacokinetic (PK) analysis of pegylated ɑ-2b included only Stratum A patients who had PK studies performed.
Samples were analyzed for pegylated interferon ɑ-2b concentrations by using the VeriKine Human Interferon Alpha ELISA Kit following the manufacturer's instructions, and concentration-time data were analyzed by nonlinear-mixed effects modeling as implemented in NONMEM."|Before first dose, and 24, 96 and 168 hours after dose during weeks 5 and 28|Only one Stratum B patient had evaluable data and is not included in final analysis, because data from more than one patient are required for nonlinear-mixed effects modeling. Two patients in Week 5 and three in Week 28 were excluded due to inadequate sampling to characterize an AUC value.||hours||Full Range|Median
749742|NCT00539591|Other Pre-specified|Area Under the Curve (AUC) of Pegylated Interferon ɑ-2B|"Pharmacokinetic (PK) analysis of pegylated ɑ-2b included only Stratum A patients who had PK studies performed.
Samples were analyzed for pegylated interferon ɑ-2b concentrations by using the VeriKine Human Interferon Alpha ELISA Kit following the manufacturer's instructions, and concentration-time data were analyzed by nonlinear-mixed effects modeling as implemented in NONMEM. AUC is given as Time 0 through infinity."|Before first dose, and 24, 96 and 168 hours after dose during weeks 5 and 28|Only one Stratum B patient had evaluable data and is not included in final analysis, because data from more than one patient are required for nonlinear-mixed effects modeling. Two patients in Week 5 and three in Week 28 were excluded due to inadequate sampling to characterize an AUC value.||pcg * hr/ml||Full Range|Median
749743|NCT00539591|Other Pre-specified|Median Steady State Trough Concentration of Pegylated Interferon ɑ-2B|"The pharmacokinetic (PK) analysis of pegylated ɑ-2b included only patients within Stratum A who had PK studies performed.
Samples were analyzed for pegylated interferon ɑ-2b concentrations by using the VeriKine Human Interferon Alpha ELISA Kit following the manufacturer's instructions, and concentration-time data were analyzed by nonlinear-mixed effects modeling as implemented in NONMEM."|Before first dose, and 24, 96 and 168 hours after dose during weeks 5 and 28|Only one patient had evaluable data in Stratum B and is not included in the final analysis, because data from more than one patient are required for nonlinear-mixed effects modeling.||pcg/ml||Full Range|Median
749744|NCT00539591|Primary|Probability of Event-free Survival (EFS) of Stratum A Participants|The probability of EFS was estimated as time to first event (relapse, death or second malignancy). As of April 2016, 21 out of 23 participants had no events. The EFS rate was estimated by Kaplan-Meier method.|3 years from diagnosis|||probability||95% Confidence Interval|Number
749745|NCT00539591|Primary|Number of Patients Who Experience Toxicity at or Above the Target Toxicity for Stratum A Patients|"The objective was to study the feasibility and safety of administering peginterferon a-2b weekly for 48 weeks following the initial induction phase to Stratum A participants.
Accrual was suspended during the 48-week course if 2 or more of 6, 4 or more of 12, 6 or more of 18, 8 or more of 24, 10 or more of 30 participants experienced target toxicity defined as:
Grade 4 non-hematologic (non-hem) toxicity that does not resolve to ≤grade 1 within 2 weeks from the time next dose is due and is determined to be probably or definitely related to protocol therapy
Grade 4 non-hem toxicity that is NOT constitutional symptoms (fever, chills, fatigue and/or pain)
Grade 3 elevations in creatinine or BUN that are determined to be probably or definitely related to protocol therapy
Grade 4 cardiopulmonary toxicity that is determined to be probably or definitely related to protocol therapy
Grade 4 mood alteration (suicidal ideation; danger to self or others)"|52 weeks|Number of participants for the analysis was based on the intent to treat population, all patients enrolled were included. Participants were enrolled on Stratum A until the accrual goals were met on Stratum B.||participants|||Number
749746|NCT00539591|Primary|Number of Patients Who Experience Toxicity at or Above the Target Toxicity for Strata B1 and B2|"The objective was to assess the safety of temozolomide administered in combination with peginterferon a-2b in Stratum B participants.
Accrual was suspended any time during therapy if 2 or more of 6, 4 or more of 12, 6 or more of 18, 8 or more of 24, 10 or more of 30 participants experienced target toxicity defined as:
Grade 4 non-hematologic (non-hem) toxicity that does not resolve to ≤grade 1 within 2 weeks from the time next dose is due and is determined to be probably or definitely related to protocol therapy
Grade 4 non-hem toxicity that is NOT constitutional symptoms (fever, chills, fatigue and/or pain)
Grade 3 elevations in creatinine or BUN that are determined to be probably or definitely related to protocol therapy
Grade 4 cardiopulmonary toxicity that is determined to be probably or definitely related to protocol therapy
Grade 4 mood alteration (suicidal ideation; danger to self or others)"|52 weeks|This toxicity report was based on intention to treat population (ITT), all patients enrolled were included. The study did not meet its accrual goals within the planned timeframe due to slow accrual.||participants|||Number
749768|NCT00545506|Primary|Tissue Oxygen Tension in the Sternal Wound|Tissue oxygen tension in the wound Tissue oxygen tension will be measured with a polarographic electrode system (Licox CMP, GMS Germany), the oxygen electrode will be calibrated with room air (154 mmHg) and then positioned within the silastic tonometer that will be inserted 2 3 cm lateral to the surgical incision.|8 hours|||mmHG|||Number
749747|NCT00539591|Primary|Tumor Response Rate|Tumor response rate of stratum B1 participants was evaluated after 1 treatment course of temozolomide plus peginterferon ɑ-2b. Complete response (CR) and partial response (PR) confirmed with repeated scan at least 4 weeks apart following completion of course 1 therapy. CR defined as disappearance of all target and non-target lesions with no new lesions detected. If available, no disease must be detected by immunocytology or serum tumor markers. PR defined as at least 30% decrease in disease measurement compared to disease measurement at study entry with no new lesions detected. Progressive disease (PD) defined as at least 20% increase in the disease measurement compared to the smallest disease measurement recorded since start of treatment, or appearance of one or more new lesions. Stable disease defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD compared to smallest disease measurement since start of treatment.|8 weeks|||participants|||Number
749748|NCT00539617|Secondary|To Determine the Effects of Erlotinib on EGFR Signaling and Tumor Cell Survival in Esophageal Cancer.||2 years||||||
749749|NCT00539617|Secondary|To Estimate the Correlation of Epidermal Growth Factor Receptor (EGFR) Gene Amplification and EGFR Gene Expression Levels in Esophageal Cancer.||2 years||||||
749750|NCT00539617|Secondary|To Determine Toxicity and Tolerability of the Erlotinib and FOLFOX Treatment Regimen in the Selected Patient Population.||2 years||||||
749751|NCT00539617|Secondary|To Determine the Time to Progression in This Population After Initiation of Erlotinib Alone, Following Erlotinib and FOLFOX Combination Chemotherapy.||2 years||||||
749752|NCT00539617|Secondary|Response Rate (RR)|To determine the number of participants with partial response (PR) or stable disease (SD) for the objective tumor response rate in the selected patient population treated with erlotinib and FOLFOX.|2 years|Only 4 patients were eligible and started the the Run-In Phase on treatment.||participants|||Number
749753|NCT00539617|Primary|Progression Free Survival (PFS)|To determine the number of participants with progression free survival after 6 months form the first day of the Erlotinib Run-In Phase for patients treated on study.|2 years|Only 4 patients were eligible and started the Run-In Phase on treatment.||participants|||Number
749754|NCT00539695|Other Pre-specified|Ancillary Studies|"To conduct ancillary studies on those patients to investigate before, during and after IL-2 administration to determine:
The immunophenotype of PBMCs
The suppressive activity of CD4+ CD25+ FoxP3+ Tregs
Cytokines secreted by PBMCs
NK cell analysis"|12 weeks||||||
749755|NCT00539695|Secondary|Immunomodulatory Effects of IL-2 Administered After Allogeneic Hematopoietic Stem Cell Transplantation Will be Evaluated by Descriptive Statistics.||12 weeks||||||
749756|NCT00539695|Secondary|Rate of Severe (Grade III or IV) Acute GVHD|To determine the efficacy of low-dose IL-2 in the prevention of severe (grade III or IV) acute GVHD|12 weeks||||||
749757|NCT00539695|Primary|Rate of Dose Limiting Toxicities|Assessment of the safety and the toxicity of low-dose IL-2, administered according to the dosage described in this protocol, in this group of patients The outcome measure is the proportion of participants with dose limiting toxicities.|6-12 weeks|||proportion of participants of DLT||95% Confidence Interval|Number
749758|NCT00539734|Primary|Time to Response (Implicit Time) of Multifocal ERG Signal|Comparing the change in time of signal response (implicit time) at 3 months after treatment with baseline data.|baseline, 3 months|||millisecond|Participants|Standard Deviation|Mean
749759|NCT00539734|Secondary|Postoperative Complication|For instance, Endophthalmitis, retinal detachment|1 month||||||
749760|NCT00539734|Primary|Height (Amplitude) of Multifocal ERG Signal|Comparing the response in hight of signal amplitude at 3 months after treatment with baseline data.|baseline, 3 months|Analysis was per protocol||nanovolt/degree^2|Participants|Standard Deviation|Mean
749761|NCT00545402|Secondary|Percentage of Participants by Graft Histology at 12 Months Post-Transplant - Central Review|The percentage of participants with biopsies of grafts evaluated by central review and scored according to Banff criteria at Month 12 post-transplant.|Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12|ITT population; only participants with evaluable biopsies were included in the analysis.||percentage of participants|||Number
749762|NCT00545402|Secondary|Overall Survival at Month 12|The median time, in months, between randomization and OS event. Participants were censored at the date of last follow up and the date of last contact or premature withdrawal.|Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12|ITT population||months||Full Range|Median
749763|NCT00545402|Secondary|Overall Survival (OS) at Month 12 - Percentage of Participants With an Event|OS was defined as the time between the date of randomization and death up to Month 12. Participants were censored at the date of last follow up and the date of last contact or premature withdrawal.|Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12|ITT population||percentage of participants|||Number
749764|NCT00545402|Secondary|Graft Survival|The median time, in months, between randomization and graft loss event. Participants were censored at the date of last follow up, the date of last contact or premature withdrawal, and date of death.|Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12, 28 days after Month 12 or last dose of study treatment, and 6 and 12 months after the last dose of study treatment.|ITT population||months||Full Range|Median
749765|NCT00545402|Secondary|Percentage of Participants With Graft Loss|Graft survival was defined as the time between the randomization date and the graft loss date. Participants were censored at the date of last follow up, the date of last contact or premature withdrawal, and date of death.|Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12, 28 days after Month 12 or last dose of study treatment, and 6 and 12 months after the last dose of study treatment.|ITT population||percentage of participants|||Number
749766|NCT00545402|Primary|Percentage of Participants With Treated Biopsy Proven Acute Rejection (BPAR) According to Banff Criteria up to 12 Months Post-Transplant|Banff criteria required at least 2 of the 3 following features for a histopathological diagnosis of acute rejection: portal inflammation, bile duct inflammation, and venous endothelial inflammation. Each item was graded from 0 to 3 where 0 equals (=) mild, 2 = moderate, and 3 = severe. The sum of the 3 individual scores, from 0 to 9, corresponded to the Rejection Activity Index (RAI). If RAI = 0, 1, or 2, there was no evidence of rejection. If RAI = 3, there was borderline acute rejection. If RAI = 4 or 5, there was mild acute rejection. If RAI = 6 or 7, there was moderate acute rejection. If RAI = 8 or 9, there was severe acute rejection.|Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12, 28 days after Month 12 or last dose of study treatment, and 6 and 12 months after the last dose of study treatment|ITT population||percentage of participants|||Number
749769|NCT00545506|Primary|Tissue Oxygenation Levels||2 years||11/2009||||
749771|NCT00545571|Secondary|Mean Dose of Mircera/CERA During the DTP and LTSP|Study drug administration occurred monthly during the DTP (Weeks 0 to 16), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during Week -1. Subsequent doses could be adjusted throughout the study including during the LTSP (Weeks 18 to 52) on the basis of Hb levels or other modification criteria. The dose received at each administration visit was averaged among all participants during the DTP and LTSP and expressed in mcg.|Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48|Safety Population; only those participants (n = number) who provided evaluable data were included in the analysis.||mcg||Standard Deviation|Mean
749772|NCT00545571|Secondary|Mean Number of Months a Participant Required Dose Adjustment of Mircera/CERA During the DTP and LTSP|Study drug administration occurred monthly during the DTP (Weeks 0 to 16), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during Week -1. Subsequent doses could be adjusted throughout the study including during the LTSP (Weeks 18 to 52) on the basis of Hb levels or other modification criteria. The mean number of months required for dose adjustment for any reason was calculated and averaged among all participants during the DTP and LTSP.|Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48|Safety Population: All participants who received at least one dose of trial medication and at least one safety follow-up assessment, whether prematurely withdrawn or not; only those participants (n = number) who provided evaluable data were included in the analysis.||months||Standard Deviation|Mean
749773|NCT00545571|Secondary|Mean Excursions Above or Below Target Range for Hb During the LTSP|During the LTSP (Weeks 18 to 52), participants provided a total of 16 pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. Sampling was also performed prior to each dialysis session. Deviation from the country-specific target range was calculated as [Hb value minus country-specific upper bound] for deviations above the target range and [Hb value minus country-specific lower bound] for deviations below the target range. Deviations were averaged among all Hb values from all participants and expressed in g/dL, reported separately as mean deviation above the upper bound (13.0 g/dL in Switzerland and 12.0 g/dL in Austria) and mean deviation below the lower bound (11.0 g/dL in Switzerland and 10.0 g/dL in Austria).|Pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48|ITT Population; only those participants (n = number) who entered the LTSP and had at least one Hb excursion during the LTSP were included in the analysis.||g/dL||Standard Deviation|Mean
749774|NCT00545571|Secondary|Mean Time Spent Above or Below the Target Range for Hb During the LTSP|During the LTSP (Weeks 18 to 52), participants provided a total of 16 pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. Sampling was also performed prior to each dialysis session. Time spent outside the country-specific target range was defined as time from each off-target Hb to time of next on-target Hb, as collected during the LTSP. Time spent outside the target range was averaged among all participants and expressed in days, reported separately as time spent above the upper bound (13.0 g/dL in Switzerland and 12.0 g/dL in Austria) and time spent below the lower bound (11.0 g/dL in Switzerland and 10.0 g/dL in Austria).|Pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48|ITT Population; only those participants (n = number) who entered the LTSP and had at least one Hb excursion during the LTSP or at the last DTP visit were included in the analysis.||days||Standard Deviation|Mean
749775|NCT00545571|Secondary|Percentage of Hb Values Above or Below the Target Range During the LTSP|During the LTSP (Weeks 18 to 52), participants provided a total of 16 pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. Sampling was also performed prior to each dialysis session. The percentage of all Hb values outside of the country-specific target range was determined and reported separately as Hb values above the upper bound (13.0 g/dL in Switzerland and 12.0 g/dL in Austria) and Hb values below the lower bound (11.0 g/dL in Switzerland and 10.0 g/dL in Austria).|Pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48|ITT Population; only those participants (n = number) who entered the LTSP and had at least one Hb excursion during the LTSP were included in the analysis.||percentage of Hb values|||Number
749776|NCT00545571|Secondary|Percentage of Participants Who Maintained Average Hb Within Target Range Throughout the EEP|During the EEP (Weeks 18 to 24), participants provided a total of four pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. Sampling was also performed prior to each dialysis session. The percentage of participants who had average Hb during the EEP in the country-specific target range (11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria) was determined. The 95% CI was calculated using the Pearson-Clopper method for exact confidence bounds.|Pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24|ITT Population.||percentage of participants||95% Confidence Interval|Number
749777|NCT00545571|Secondary|Mean Time Spent in the Target Range for Hb During the Long-Term Safety Period (LTSP)|During the LTSP (Weeks 18 to 52), participants provided a total of 16 pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. Sampling was also performed prior to each dialysis session. Time spent in the country-specific target range (11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria) was defined as time from first on-target Hb to time of last known on-target Hb, as collected during the EEP. Time spent in the target range was averaged among all participants and expressed in days.|Pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48|ITT Population; only participants who entered the LTSP were included in the analysis.||days||Standard Deviation|Mean
749778|NCT00545571|Secondary|Mean Change in Time-Adjusted Hb From Baseline to EEP|"Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment stability assessment (Weeks -4 to 0). During the EEP (Weeks 18 to 24), participants provided a total of four pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. Sampling was also performed prior to each dialysis session. The average Hb during the EEP was calculated per participant and assessed against the reference value. The mean change in Hb value between reference (i.e., Baseline) Hb and the EEP average Hb was calculated and expressed in g/dL."|At Weeks -4, -3, -2, -1, 0; pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24|ITT Population.||g/dL||Standard Deviation|Mean
750566|NCT00546052|Other Pre-specified|Absolute Change in Uric Acid Between Baseline and 52 Week Assessments|Absolute Change in Uric Acid Between Baseline and 52 week assessments: Uric Acid 52 weeks – Uric Acid Baseline.|52 Weeks - Baseline|Per Protocol||mmol/L||Standard Deviation|Mean
749779|NCT00545571|Primary|Percentage of Participants Who Maintained Average Hb Within Plus/Minus (±) 1 g/dL of Reference Hb or Within Target Range During the Efficacy Evaluation Period (EEP)|Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment stability assessment (Weeks -4 to 0). During the EEP (Weeks 18 to 24), participants provided a total of four pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. Sampling was also performed prior to each dialysis session. The average Hb during the EEP was calculated per participant and assessed against the reference value. The percentage of participants who had average Hb during the EEP in the country-specific target range (11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria) and within ±1 g/dL of their individual reference Hb was determined as the primary endpoint. The 95 percent (%) confidence interval (CI) was calculated using the Pearson-Clopper method for exact confidence bounds.|At Weeks -4, -3, -2, -1, 0; pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24|Per Protocol (PP) Population: All participants from the Intent-to-Treat (ITT) Population who fulfill select criteria per study protocol.||percentage of participants||95% Confidence Interval|Number
749782|NCT00545623|Primary|Changes in GI Symptom Per Intervention Session|We used the GI symptom subscale of the Revised HIV Sign and Symptom Checklist (SSC-HIV) to measure the intensity (0-10) of the six targeted GI symptoms: diarrhea, loose stools, gas/bloating, abdominal pain, nausea and vomiting, with 0 indicating no symptom and 10 indicating most sever symptom. Rating changes per intervention session were estimated using a mixed effects regression model controlling for baseline ratings. Data of loose stools are presented here.|8 weeks|An intent-to-treat approach was used for analysis. That is all patients who had at least one data points were included in the analysis.||units on a scale||Standard Error|Mean
749783|NCT00545662|Primary|Functional and Cognitive Outcome|The primary outcome of this study was analyzed using a global statistic of the Network Core Battery. There were 9 scales: California Verbal Learning Test II (CVLT-II); Controlled Oral Word Association Test (COWAT); Digit Span (DS); Glasgow Outcome Scale Extended (GOSE); Processing Speed Index (PSI); Stroop Test 1 and 2 (ST1&2); and Trail Making Test part A and B (TMT parts A and B). Each scale was assigned cut-off for good outcome: GOSE>7, CVLT>36, PSI>85, TMT part A <42, TMT part B<138.1, DS>7.15, ST1<60.29, ST2<151.47, COWAT>32.5. Logistic regression was used to estimate the global OR.|90 days|The analysis included both the patients with complete outcome data and those with at least one measure. Patients who died were also included in the analysis.||percentage of participants|||Number
749784|NCT00545688|Secondary|Progression Free and Disease Free Survival|DFS was defined as the time from the first date of no disease (date of surgery) to the first documentation of PD or death. Participants without progression after surgery were considered Disease Free. Any evidence of contralateral disease in-situ was not considered as PD. PFS was defined as the time from the date of randomization to the first documentation of PD or death. Any evidence of contralateral disease in-situ was not considered as PD. DFS and PFS were determined using Kaplan-Meier estimates.|Randomization up to a maximum of 329 weeks|ITT Population; Analysis was performed according to initial randomization.||percentage of participants||80% Confidence Interval|Median
749785|NCT00545688|Secondary|Percentage of Participants Who Were Progression Free and Disease Free|Disease-free survival (DFS) was defined as the time from first date of no disease to first documentation of PD or death. Participants without progression after surgery were considered Disease Free. Any evidence of contralateral disease in-situ was not considered as PD. Participants who were withdrawn from the study without documented progression and for whom evaluations were made, were censored at date of last assessment when participant was known to be disease-free. Progression-free survival (PFS) was defined as time from date of randomization to first documentation of PD or death. Any evidence of contralateral disease in-situ was not considered as PD. Participants who were withdrawn from study without documented progression and for whom evaluations were made, were censored at date of last assessment when the participant was known to be free from progressive disease. Participants without post baseline assessments but known to be alive were censored at the time of randomization.|Randomization up to a maximum of 329 weeks|ITT Population; Analysis was performed according to initial randomization.||percentage of participants|||Number
749786|NCT00545688|Secondary|Percentage of Participants Achieving Breast Conserving Surgery For Whom Mastectomy Was Planned|Breast Conserving Surgery (BCS) was defined as quadrantectomy, lumpectomy, no surgery, sentinel node biopsy, axillary surgical resection or other method of avoiding mastectomy.|Surgery (Within 2 weeks after Cycle 4) Up to approximately 24 months|ITT Population; Analysis was performed according to initial randomization. Number of participants analyzed = participants evaluable for this outcome.||percentage of participants||95% Confidence Interval|Number
749787|NCT00545688|Secondary|Percentage of Participants With Progressive Disease During Neo-Adjuvant Treatment Period|Tumor assessments were made based upon the Response Evaluation Criteria in Solid Tumors (RECIST) criteria - version 1.0. The clinical response at each cycle up to the last assessment prior to surgery was derived for: i) the primary breast lesion; (ii) across secondary breast lesions, (iii) across all breast lesions (iv) across axillary nodes (v) across supraclavicular nodes and (vi) across all nodes (vii) across all lesions (overall) using the following algorithm: PD: if lesion is at least a 20 % increased from measurements at baseline. Percentage of participants along with 95% Confidence Interval (CI) for one sample binomial using Pearson-Clopper method were reported. Missing investigator assessments were considered as no progressive disease.|Baseline up to Cycle 4 (assessed at Baseline, Day 1 of Cycles 1-4 Pre-Surgery) Up to approximately 24 months|ITT Population; Analysis was performed according to initial randomization.||percentage of participants||95% Confidence Interval|Number
749788|NCT00545688|Secondary|Time to Clinical Response During Neo-Adjuvant Treatment Period|Time to clinical response was defined as the time from the date of first dose received to the date of assessment of clinical response. Time to Clinical response was determined by Kaplan-Meier estimates. Tumor assessments were made based on the RECIST criteria - version 1.0. The clinical response at each cycle up to the last assessment prior to surgery was derived for: i) the primary breast lesion; (ii) across secondary breast lesions, (iii) across all breast lesions (iv) across axillary nodes (v) across supraclavicular nodes and (vi) across all nodes (vii) across all lesions (overall) using the following algorithm: CR: if measurement of '0' is noted at a given cycle as compared to baseline measurement which is >0 at screening or cycle 1 day 1; PR: if measurement is at least a 30% decreased compared to baseline levels . (Reference= baseline size or sum of sizes). Clinical Responders are participants who have achieved CR or PR during the Neo-adjuvant treatment.|Baseline up to Cycle 4 (assessed at Baseline, Day 1 of Cycles 1-4 Pre-Surgery) Up to approximately 24 months|ITT Population; Analysis was performed according to initial randomization. Number of participants analyzed = participants evaluable for this outcome.||months||80% Confidence Interval|Median
749789|NCT00545688|Secondary|Percentage of Participants Achieving Clinical Response During Neo-Adjuvant Period by Clinical Examination|Tumor assessments were made based on the RECIST criteria - version 1.0 The clinical response at each cycle up to the last assessment prior to surgery was derived for: i) the primary breast lesion; (ii) across secondary breast lesions, (iii) across all breast lesions (iv) across axillary nodes (v) across supraclavicular nodes and (vi) across all nodes (vii) across all lesions (overall) using the following algorithm: CR: if measurement of ‘0’ is noted at a given cycle as compared to baseline measurement which is >0 at screening or cycle 1 day 1; PR: if measurement is at least a 30% decreased compared to baseline levels . (Reference= baseline size or sum of sizes). Clinical Responders are participants who have achieved CR or PR during the Neo-adjuvant treatment. Primary breast tumor clinical response is based on primary breast tumor assessment. Overall response is derived based on the sum total of breast tumors and all nodes examined.|Baseline up to Cycle 4 (assessed at Baseline, Day 1 of Cycles 1-4 Pre-Surgery) Up to approximately 24 months|ITT Population; Analysis was performed according to initial randomization. Number of participants analyzed = participants evaluable for this outcome and n = number participants analyzed in the specified category.||percentage of participants||95% Confidence Interval|Number
749790|NCT00545688|Secondary|Percentage of Participants Achieving Clinical Response During Neo-Adjuvant Period by X-Ray/Mammography|Clinical response was determined based on tumor measurements by sponsor in combination with tumor response assessment by investigator. Tumor assessments were made based on the RECIST criteria - version 1.0 The clinical response at each cycle up to the last assessment prior to surgery was derived for: i) the primary breast lesion; (ii) across secondary breast lesions, (iii) across all breast lesions (iv) across axillary nodes (v) across supraclavicular nodes and (vi) across all nodes (vii) across all lesions (overall) using the following algorithm: CR: if measurement of ‘0’ is noted at a given cycle as compared to baseline measurement which is >0 at screening or cycle 1 day 1; PR: if measurement is at least a 30% decreased compared to baseline levels . (Reference= baseline size or sum of sizes). Clinical Responders are participants who have achieved CR or PR during the Neo-adjuvant treatment. Overall response is derived based on the sum total of breast tumors and all nodes examined.|Baseline up to Cycle 4 (assessed at Baseline, Day 1 of Cycles 1-4 Pre-Surgery) Up to approximately 24 months|ITT Population; Analysis was performed according to initial randomization. Number of participants analyzed = participants evaluable for this outcome and n = number participants analyzed in the specified category.||percentage of participants||95% Confidence Interval|Number
749791|NCT00545688|Secondary|Percentage of Participants Achieving Best Overall Response (CR, PR, SD or PD) During the Neo-Adjuvant Period by Clinical Examination|Tumor assessments were made based on the RECIST criteria - version 1.0 The clinical response at each cycle up to the last assessment prior to surgery was derived for: i) the primary breast lesion; (ii) across secondary breast lesions, (iii) across all breast lesions (iv) across axillary nodes (v) across supraclavicular nodes and (vi) across all nodes (vii) across all lesions (overall) using the following algorithm: CR: if measurement of ‘0’ is noted at a given cycle as compared to baseline measurement which is >0 at screening or cycle 1 day 1; PR: if measurement is at least a 30% decreased compared to baseline levels . (Reference= baseline size or sum of sizes); SD: if measurement at a given cycle is not sufficient shrinkage to qualify for neither PR nor sufficient increase to qualify for PD compared to baseline levels. PD: if lesion is at least a 20 % increase from measurements at baseline. Overall response is derived based on the sum total of breast tumors and all nodes examined.|Baseline up to Cycle 4 (assessed at Baseline, Day 1 of Cycles 1-4 Pre-Surgery) Up to approximately 24 months|ITT Population; Analysis was performed according to initial randomization. Number of participants analyzed = participants evaluable for this outcome.||percentage of participants|||Number
749792|NCT00545688|Secondary|Percentage of Participants Achieving Best Primary Breast Tumor Response (CR, PR, SD or PD) During Neo-Adjuvant Period by Clinical Examination|Tumor assessments were made based on the RECIST criteria - version 1.0 The clinical response at each cycle up to the last assessment prior to surgery was derived for primary breast tumor using the following algorithm: CR: if measurement of ‘0’ is noted at a given cycle as compared to baseline measurement which is >0 at screening or cycle 1 day 1; PR: if measurement is at least a 30% decreased compared to baseline levels . (Reference= baseline size or sum of sizes); SD: if measurement at a given cycle is not sufficient shrinkage to qualify for neither PR nor sufficient increase to qualify for PD compared to baseline levels. PD: if lesion is at least a 20 % increase from measurements at baseline. Overall response is derived based on the sum total of breast tumors and all nodes examined.|Baseline up to Cycle 4 (assessed at Baseline, Day 1 of Cycles 1-4 Pre-Surgery) Up to approximately 24 months|ITT Population; Analysis was performed according to initial randomization. Number of participants analyzed = participants evaluable for this outcome.||percentage of participants|||Number
749811|NCT00546715|Primary|Number of Participants With Clinically Significant Change From Baseline in Vital Sign Measurements and Physical Examination Findings|Participants were assessed by investigator for any clinically significant changes in vital parameters like body temperature, respiratory rate, blood pressure, heart rate and weight. The assessment was performed by a calibrated sphygmomanometer and thermometer for blood pressure and temperature, respectively. Blood pressure and heart rate were measured after at least 5 minutes quiet seating of the subject. Weight was measured at the discharge. The criteria for clinically significant change was as per the investigators discretion.|Day 1 up to Day 7 or Discharge|The analysis was performed in the safety population.||participants|||Number
749793|NCT00545688|Secondary|Percentage of Participants Achieving Best Overall Response (CR, PR, SD or PD) During Neo-Adjuvant Period by X-Ray/Mammography|Tumor assessments were made based on the RECIST criteria - version 1.0 The overall response at each cycle up to the last assessment prior to surgery was derived for: i) the primary breast lesion; (ii) across secondary breast lesions, (iii) across all breast lesions (iv) across axillary nodes (v) across supraclavicular nodes and (vi) across all nodes (vii) across all lesions (overall) using the following algorithm: CR: if measurement of ‘0’ is noted at a given cycle as compared to baseline measurement which is >0 at screening or cycle 1 day 1; PR: if measurement is at least a 30% decreased compared to baseline levels . (Reference= baseline size or sum of sizes); SD: if measurement at a given cycle is not sufficient shrinkage to qualify for neither PR nor sufficient increase to qualify for PD compared to baseline levels. PD: if lesion is at least a 20 % increase from measurements at baseline. Overall response is derived based on the sum total of breast tumors and all nodes examined.|Baseline up to Cycle 4 (assessed at Baseline, Day 1 of Cycles 1-4 Pre-Surgery) Up to approximately 24 months|ITT Population; Analysis was performed according to initial randomization. Number of participants analyzed = participants evaluable for this outcome.||percentage of participants|||Number
749794|NCT00545688|Primary|Percentage of Participants Achieving pCR by Presence or Absence of Residual Intraductal Carcinoma (DCIS) / Intalobular Carcinoma (LCIS)|pCR was defined as an absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy. Participants with invalid/missing pCR assessments were defined as non-responders.|Approximately 4 months from randomization following surgery or early withdrawal, whichever occurred first (Surgery was performed within 2 weeks after Cycle 4)|ITT Population; Analysis was performed according to initial randomization.||percentage of participants|||Number
749795|NCT00545688|Primary|Percentage of Participants Achieving pCR by Lymph Node Status|pCR was defined as an absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy. Lymph node status was defined as either negative lymph node at surgery or positive lymph node at surgery. Participants with invalid/missing pCR assessments were defined as non-responders.|Approximately 4 months from randomization following surgery or early withdrawal, whichever occurred first (Surgery was performed within 2 weeks after Cycle 4)|ITT Population; Analysis was performed according to initial randomization.||percentage of participants|||Number
749796|NCT00545688|Primary|Percentage of Participants Achieving pCR by Hormone Receptor Status|pCR was defined as an absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy. Participants were classified as Estrogen and/or Progesterone positive (+ve), Estrogen and/or Progesterone negative (-ve) or receptor status unknown. Participants with invalid/missing pCR assessments were defined as non-responders.|Approximately 4 months from randomization following surgery or early withdrawal, whichever occurred first (Surgery was performed within 2 weeks after Cycle 4)|ITT Population; Analysis was performed according to initial randomization. n = number of participants included in the specified hormone receptor status.||percentage of participants||95% Confidence Interval|Number
749797|NCT00545688|Primary|Percentage of Participants Achieving pCR by Breast Cancer Type|pCR was defined as an absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy. Based on the type of breast cancer participants were categorized as those with 1. Operable breast cancer, 2. Inflammatory breast cancer and 3. Locally advanced breast cancer. Participants with invalid/missing pCR assessments were defined as non-responders.|Approximately 4 months from randomization following surgery or early withdrawal, whichever occurred first (Surgery was performed within 2 weeks after Cycle 4)|ITT Population; Analysis was performed according to initial randomization. Number (n) equal (=) number of participants included in the specified type of breast cancer.||percentage of participants||95% Confidence Interval|Number
749798|NCT00545688|Secondary|Percentage of Participants Achieving Best Primary Tumor Response (Complete Response [CR], Partial Response [PR], Stable Disease [SD] or Disease Progression [PD]) During Neo-Adjuvant Treatment by X-Ray/Mammography|Tumor assessments were made based upon the Response Evaluation Criteria in Solid Tumors (RECIST) criteria - version 1.0. The clinical response at each cycle up to the last assessment prior to surgery was derived for primary breast tumor using the following algorithm: CR: if measurement of ‘0’ is noted at a given cycle as compared to baseline measurement which is greater than (>)0 at screening or cycle 1 Day 1; PR: if measurement is at least a 30 percent (%) decreased compared to baseline levels . (Reference= baseline size or sum of sizes); SD: if measurement at a given cycle is not sufficient shrinkage to qualify for neither PR nor sufficient increase to qualify for PD compared to baseline levels. PD: if lesion is at least a 20 % increase from measurements at baseline.|Baseline up to Cycle 4 (assessed at, Baseline and Day 1 of Cycles 1-4 Pre-Surgery) Up to approximately 24 months|ITT Population; Analysis was performed according to initial randomization. Number of participants analyzed = participants evaluable for this outcome.||percentage of participants|||Number
749799|NCT00545688|Primary|Percentage of Participants Achieving Pathological Complete Response (pCR)|pCR was defined as an absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy. Participants with invalid/missing pCR assessments were defined as non-responders|Approximately 4 months from randomization following surgery or early withdrawal, whichever occurred first (Surgery was performed within 2 weeks after Cycle 4)|ITT Population; Analysis was performed according to initial randomization.||percentage of participants||95% Confidence Interval|Number
749800|NCT00546715|Secondary|Change From Baseline in Blood Pressure to Day 7 or Discharge|Changes in blood pressure from baseline were measured after the participants were supine for at least 5 minutes. Baseline was defined as the Day 1 pre-dose measurement.|Baseline (Day 1), Day 7 or Discharge|||mmHg||Standard Deviation|Mean
749812|NCT00546715|Primary|Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs) and Who Died|AEs were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding) or disease which either occurs during study, whether or not related to the study drug. SAEs were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards.|Day 1 up to Day 7 for non-SAEs and Day 1 to 30 days after study discontinuation for SAEs|Analysis was performed in safety population defined as all participants who received any study drug treatment.||participants|||Number
749801|NCT00546715|Secondary|Change From Baseline in Electrocardiogram (ECG) Parameters (PR, QRS, QT, and QTc Intervals) to Day 7 or Discharge|The ECG was recorded after the participant was in a supine position for at least 5 minutes. Baseline was defined as the Day 1 pre-dose measurement. The PR interval was defined as the beginning of the P wave to the beginning of the QRS complex, and represents the time taken by electrical impulse to travel from the sinus node through the atrioventricular (AV) node. The QRS complex represented the rapid depolarization of the right and left ventricles. The QT interval was defined as the time from the start of the Q wave to the end of the T wave, and represents the time taken for ventricular depolarization and repolarization. QTc was defined as corrected QT interval at a heart rate of 60 bpm. QTc was estimated using Bazett’s formula and Fredericia’s formula.|Baseline (Day 1), Day 7 or Discharge|The analysis was performed in the safety population.||msec||Standard Deviation|Mean
749802|NCT00546715|Secondary|Change From Baseline in Heart Rate to Day 7 or Discharge|Changes in heart rate from baseline were measured after the participants were supine for at least 5 minutes. Baseline was defined as the Day 1 pre-dose measurement. The normal heart rate lies between 60-90 beats per minute (bpm), below 60 bpm and above 90 bpm were considered as bradycardia and tachycardia, respectively.|Baseline (Day 1), Day 7 or Discharge|The analysis was performed in the safety population.||bpm||Standard Deviation|Mean
749803|NCT00546715|Secondary|Time to Reach Maximum Decline in Plasma Hepatitis C Virus RNA Levels From Baseline|Participants were assessed for time to reach maximum decrease in log10 hepatitis C virus RNA level. Baseline HCV RNA was defined as the pre-dose value on Day 1 log10 HCV RNA.|Pre-dose, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 144 hours post-dose on Day 1|The analysis was performed in the PD population defined as participants who received at least one dose of study medication with available valid data.||hours||Standard Deviation|Mean
749804|NCT00546715|Secondary|Decline From Baseline in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)|The Roche TaqMan HCV quantitative assay was used for analysis with detection limit of 10 IU/mL. Positive value indicated reduction from baseline in HCV RNA while negative value indicated an increase from baseline in HCV RNA. Baseline HCV RNA was defined as the pre-dose value on Day 1 log10 HCV RNA.|Pre-dose, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 144 hours post-dose on Day 1|The analysis was performed in the pharmacodynamic (PD) population defined as participants who received at least one dose of study medication with available valid data.||log IU/mL||Standard Deviation|Mean
749805|NCT00546715|Secondary|Apparent Total Body Clearance (CLT/F)|Apparent total body clearance (CLT/F) was calculated as Dose/AUC(INF), where CLT was the clearance of the drug and F was the absolute oral bioavailability. The plasma samples were analyzed for daclatasvir using a validated liquid chromatography-tandem mass spectrometric assay.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48 and 72 hours post-dosing on Day 1|The analysis was performed in the PK set population.||mL/min||Geometric Coefficient of Variation|Geometric Mean
749806|NCT00546715|Secondary|Plasma Half-life (T-half)|Plasma half-life was defined as the time required for one half of the total amount of administered drug eliminated from the body. The plasma samples were analyzed for daclatasvir using a validated liquid chromatography-tandem mass spectrometric assay.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48 and 72 hours post-dosing on Day 1|The analysis was performed in the PK set population.||hours||Standard Deviation|Mean
749807|NCT00546715|Secondary|Time to Reach Maximum Plasma Concentration (Tmax)|Tmax was defined as the time required to reach maximum observed plasma concentration. The plasma samples were analyzed for daclatasvir using a validated liquid chromatography-tandem mass spectrometric assay.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48 and 72 hours post-dosing on Day 1|The analysis was performed in the PK set population.||hours||Full Range|Median
749808|NCT00546715|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC[0-T]), Area Under the Plasma Concentration-time Curve From Time Zero (AUC[INF]) Extrapolated to Infinite Time|Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration. It was calculated as the sum of linear trapezoids using non-compartmental analysis. Area under the plasma concentration-time curve from time zero extrapolated to infinite time was estimated as sum of AUC(0-T) and the extrapolated area, computed by the quotient of the last observable concentration and λ, where λ was the slopes of the terminal phases of the plasma concentration-time profiles. The plasma samples were analyzed for daclatasvir using a validated liquid chromatography-tandem mass spectrometric assay.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48 and 72 hours post-dosing on Day 1|The analysis was performed in the PK set population.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
749809|NCT00546715|Secondary|Maximum Observed Plasma Concentration (Cmax) and Observed Plasma Concentration at 12 Hours (C-12) and 24 Hours (C-24)|Maximum observed plasma concentration following drug administration from the raw plasma concentration-time data. C-12 and C-24 were defined as observed plasma concentration of daclatasvir at 12 hours and 24 hours, respectively. The plasma samples were analyzed for daclatasvir using a validated liquid chromatography-tandem mass spectrometric assay.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48 and 72 hours post-dosing on Day 1|The analysis was performed in the pharmacokinetic (PK) set population defined as all participants who received at least single dose of daclatasvir with available valid data.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
749810|NCT00546715|Primary|Number of Participants With Marked Abnormalities in Laboratory Findings|Laboratory marked abnormalities were defined as Hematocrit (low) as <0.85*pre-treatment value, Leukocytes (low) as <0.9*lower limit of normal, Aspartate Aminotransferase (high) as >1.25*upper limit of normal, Creatinine (high) as >1.33*pre-treatment value, Bicarbonate (high) as >1.2*upper limit of normal, Total Protein (high) as >1.1*upper limit of normal, Creatinine Kinase (high) as >1.5*upper limit of normal, Blood in Urine (high) as ≥ 2*upper limit of normal. Participants were fasted for at least 10 hours prior to the collection of blood specimens for clinical laboratory tests.|Day 1 up to Day 7|The analysis was performed in the safety population.||participants|||Number
749813|NCT00546728|Primary|Change in Reactive Hyperemic Index Over the 3-month Treatment Period|Change in reactive hyperemic index over the 3-month treatment period, which is a measure of endothelial (inner lining of blood vessels) function. This is measured as a ratio of post-occlusion blood flow volume versus baseline blood flow volume in fingertips. Higher ratio values are considered indicative of better arterial health.|Change from baseline to 3 months|All completers were included in the analysis||ratio||Standard Deviation|Mean
757493|NCT00608491|Secondary|Change in Blood Hemoglobin Level||Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||g/dL||Standard Deviation|Mean
749814|NCT00546754|Secondary|Change in Gamma-Glutamyl Transpeptidase (Gamma–GT) From Baseline to Week 12||Baseline and Week 12|416 and 373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 279 and 254 patients at week 12 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively||IU/L||Standard Deviation|Mean
749815|NCT00546754|Secondary|Change in Gamma-Glutamyl Transpeptidase (Gamma-GT) From Baseline to Week 6||Baseline and Week 6|416 and 373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 300 and 273 patients at week 6 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively||IU/L||Standard Deviation|Mean
749816|NCT00546754|Secondary|Change in Serum Highly Sensitive C-reactive Protein From Baseline to Week 12||Baseline and Week 12|416 and 373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 279 and 255 patients at week 12 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively||umol/L||Standard Deviation|Mean
749817|NCT00546754|Secondary|Change in Serum Highly Sensitive C-reactive Protein From Baseline to Week 6||Baseline and Week 6|416 and 373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 304 and 272 patients at week 6 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively||mg/L||Standard Deviation|Mean
749818|NCT00546754|Secondary|Change in Uric Acid From Baseline to Week 12||Baseline and Week 12|416 and 373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 286 and 253 patients at week 12 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively||umol/L||Standard Deviation|Mean
749819|NCT00546754|Primary|Change in Diastolic Blood Pressure From Baseline to Week 12||Baseline and Week 12|416 and 373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 371 and 331 patients at week 12 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively||mm Hg||Standard Deviation|Mean
749820|NCT00546754|Secondary|Change in Uric Acid From Baseline to Week 6||Baseline and Week 6|416 and 373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 298 and 269 patients at week 6 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively||umol/L||Standard Deviation|Mean
749821|NCT00546754|Secondary|Time to Achieve Target Blood Pressure|Time to achieve the target blood pressure (<140/90 mmHg and <130/80 mmHg for diabetics)|12 weeks|416 and 373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 406 and 360 patients for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively||Days||Standard Deviation|Mean
749822|NCT00546754|Secondary|Number of Patients Achieving Target Blood Pressure at Week 12|Number of Patients Achieving Target Blood Pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics) at week 12|12 Weeks|416 and 373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 372 and 332 patients at week 12 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively||Patients|||Number
749823|NCT00546754|Primary|Change in Systolic Blood Pressure From Baseline to Week 12||Baseline and Week 12|416 and 373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 371 and 331 patients at week 12 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively||mm Hg||Standard Deviation|Mean
749824|NCT00546754|Secondary|Number of Patients Achieving Target Blood Pressure at Week 6|Number of Patients Achieving Target Blood Pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics) at week 6|Week 6|416 and 373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 393 and 345 patients at week 6 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively||Patients|||Number
749825|NCT00546754|Secondary|Change in Diastolic Blood Pressure From Baseline to Week 6||Baseline and Week 6|416 and 373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 392 and 344 patients at week 6 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively||mm Hg||Standard Deviation|Mean
749826|NCT00546754|Secondary|Change in Systolic Blood Pressure From Baseline to Week 6||Baseline and Week 6|416 and 373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 392 and 344 patients at week 6 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively||mm Hg||Standard Deviation|Mean
749827|NCT00546819|Secondary|Geometric Mean Fold Rise (GMFR) of the VZV Antibody Response From Day 1 to Day 42 Postvaccination.|The geometric mean fold rise (GMFR) of the VZV antibodies from Day 1 to Week 6 postvaccination.|42 days postvaccination|Per-protocol population: All vaccinated participants who had serology results and who had no protocol deviations that would interfere with the evaluation of VZV-specific gpELISA antibody response.||Ratio||95% Confidence Interval|Mean
749828|NCT00546819|Secondary|Geometric Mean Titer (GMT) of Varicella-Zoster Virus (VZV) Antibodies at 42 Days Postvaccination|The Geometric Mean Titer (GMT) of VZV antibodies in participants' serum samples was assessed by a glycoprotein enzyme-linked immunosorbent assay (gpELISA).|42 days postvaccination|Per-protocol population: All vaccinated participants who had serology results and who had no protocol deviations that would interfere with the evaluation of VZV-specific gpELISA antibody response.||gpELISA units/mL||95% Confidence Interval|Mean
749829|NCT00546819|Primary|Number of Participants With Serious Adverse Events (SAE)|"A serious adverse event is defined as any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an other important medical event based on medical judgement."|Up to 182 days postvaccination|"All participants who were vaccinated and had any safety
follow-up were included in the safety analysis."||Participants|||Number
749830|NCT00546871|Secondary|Percentage of Infusions Associated With ≥1 Local AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion.||During Infusion or Within 72 Hours of Completion of Infusions|All participants who received any study drug||Percentage of infusions|Participants||Number
749831|NCT00546871|Primary|Percentage of Infusions in SESC for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped|Ability to tolerate IGIV, 10% administered IV or SC. Measured as the percentage of infusions for which the infusion rate was reduced at any infusion and/or the infusion was interrupted or stopped for (i) any reason and (ii) for tolerability concerns or AEs|Throughout study (1 year and 9 months)|SESC data set (all participants with prior experience with subcutaneous administration of immunoglobulins who received any study drug)||Percentage of Infusions|Participants|95% Confidence Interval|Number
749832|NCT00546871|Primary|Percentage of Infusions in SNSC for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped|Ability to tolerate IGIV, 10% administered IV or SC. Measured as the percentage of infusions for which the infusion rate was reduced at any infusion and/or the infusion was interrupted or stopped for (i) any reason and (ii) for tolerability concerns or AEs|Throughout study (1 year and 9 months)|SNSC data set (all participants naïve to SC administration of immunoglobulins who received any study drug)||Percentage of Infusions|Participants|95% Confidence Interval|Number
749833|NCT00546871|Primary|Percentage of Infusions in FSDS for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped|Ability to tolerate IGIV, 10% administered IV or SC. Measured as the percentage of infusions for which the infusion rate was reduced at any infusion and/or the infusion was interrupted or stopped for (i) any reason and (ii) for tolerability concerns or AEs|Throughout study (1 year and 9 months)|Full safety data set (all participants who received any study drug)||Percentage of Infusions|Participants|95% Confidence Interval|Number
749834|NCT00546871|Primary|Percentage of Participants With Prior Experience With Subcutaneous Administration of Immunoglobulins (SESC) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped|Ability to tolerate IGIV, 10% administered IV or SC. Measured as the percentage of participants for which the infusion rate was reduced at any infusion and/or the infusion was interrupted or stopped for (i) any reason and (ii) for tolerability concerns or AEs|Throughout study (1 year and 9 months)|SESC data set (all participants with prior experience with subcutaneous administration of immunoglobulins who received any study drug)||Percentage of Participants|||Number
749835|NCT00546871|Secondary|Percentage of Infusions Associated With ≥1 Systemic AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion.||During Infusion or Within 72 Hours of Completion of Infusions|All participants who received any study drug||Percentage of infusions|Participants||Number
749836|NCT00546871|Secondary|Percentage of Infusions Associated With ≥1 AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion.||During Infusion or Within 72 Hours of Completion of Infusions|All participants who received any study drug||Percentage of infusions|Participants||Number
749837|NCT00546871|Secondary|Percentage of Infusions Associated With ≥1 AEs That Begin During Infusion or Within 72 Hours of Completion of Infusion||During Infusion or Within 72 Hours of Completion of Infusions|All participants who received any study drug||Percentage of infusions|Participants||Number
749838|NCT00546871|Secondary|Percentage of Infusions Associated With ≥1 AE Related to the Study Drug||Throughout the study period (1 year and 9 months)|All participants who received any study drug||Percentage of infusions|Participants||Number
749839|NCT00546871|Secondary|Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC)|"Seriousness and causality are abbreviated below as:
Seriousness: Serious Adverse Event= SAE, non-Serious Adverse Event= non-SAE Causality: possibly or probably related= R, not related= NR
Rate of AEs defined as the number of AEs categorized by MedDRA preferred terms, seriousness, severity, and causality divided by the number of infusions."|Throughout entire study (1 year and 9 months)|All study participants with prior experience with subcutaneous administration of immunoglobulins who received any study drug during each of the study parts||AEs per infusion|||Number
749840|NCT00546871|Secondary|Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC)|"Seriousness and causality are abbreviated below as:
Seriousness: Serious Adverse Event= SAE, non-Serious Adverse Event= non-SAE Causality: possibly or probably related= R, not related= NR"|Throughout entire study (1 year and 9 months)|All study participants with prior experience with subcutaneous administration of immunoglobulins who received any study drug during each of the study parts||Adverse events|||Number
749841|NCT00546871|Secondary|Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages)|"Seriousness and causality are abbreviated below as:
Seriousness: Serious Adverse Event= SAE, non-Serious Adverse Event= non-SAE Causality: possibly or probably related= R, not related= NR
Rate of AEs defined as the number of AEs categorized by MedDRA preferred terms, seriousness, severity, and causality divided by the number of infusions."|Throughout entire study (1 year and 9 months)|Study participants who are naïve to SC administration of immunoglobulins and received any study drug during each of the study parts||AEs per infusion|||Number
749842|NCT00546871|Secondary|Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages)|"Seriousness and causality are abbreviated below as:
Seriousness: Serious Adverse Event= SAE, non-Serious Adverse Event= non-SAE Causality: possibly or probably related= R, not related= NR"|Throughout entire study (1 year and 9 months)|Study participants who are naïve to SC administration of immunoglobulins and received any study drug during each of the study parts||Adverse events|||Number
749843|NCT00546871|Secondary|Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS)|"Seriousness and causality are abbreviated below as:
Seriousness: Serious Adverse Event= SAE, non-Serious Adverse Event= non-SAE Causality: possibly or probably related= R, not related= NR
Rate of AEs defined as the number of AEs categorized by MedDRA preferred terms, seriousness, severity, and causality divided by the number of infusions."|Throughout entire study (1 year and 9 months)|All study participants who received any study drug during each of the study parts||AEs per infusion|||Number
749844|NCT00546871|Secondary|Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS)|"Seriousness and causality are abbreviated below as:
Seriousness: Serious Adverse Event= SAE, non-Serious Adverse Event= non-SAE Causality: possibly or probably related= R, not related= NR"|Throughout entire study (1 year and 9 months)|All study participants who received any study drug during each of the study parts||Adverse events|||Number
751022|NCT00555620|Secondary|Tmax for 5'DFCR||Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; number of participants analyzed (N): participants with evaluable data||hr||Full Range|Median
749845|NCT00546871|Primary|Percentage of Participants Naïve to SC Administration of Immunoglobulins (SNSC) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped.|Ability to tolerate IGIV, 10% administered IV or SC. Measured as the percentage of participants for which the infusion rate was reduced at any infusion and/or the infusion was interrupted or stopped for (i) any reason and (ii) for tolerability concerns or AEs|Throughout study (1 year and 9 months)|SNSC data set (all participants naïve to SC administration of immunoglobulins who received any study drug)||Percentage of Participants|||Number
749846|NCT00546871|Secondary|Proportion of Participants Reporting ≥1 Temporally Associated Moderate or Severe AEs|Proportion of Participants Reporting 1 or More Moderate or Severe AEs That Begin During Infusion or Within 72 Hours of Completion of an Infusion.|During Infusion or Within 72 Hours of Completion of Infusions|All participants who received any study drug||Proportion of participants|||Number
749847|NCT00546871|Secondary|Frequency of Dose Adjustments (If IgG Trough Levels <4.5 g/L)|"Frequency of Dose Adjustments Based on IgG Trough Levels <4.5 g/L IgG, if Any, for Each Study Part.
Defined/calculated as the number of participants requiring dose adjustments divided by the number of participants, for each respective data set."|Throughout the study period (1 year and 9 months)|All participants who received any study drug||ratio|||Number
749848|NCT00546871|Secondary|AEs Deemed/Judged to be Related by the Investigator|Rate of related AEs defined as the total number of AEs determined by the investigator to be related to the study drug that occur at any time during the study divided by the total number of infusions.|Throughout the study period (1 year and 9 months)|All participants who received any study drug||AEs per infusion|Participants||Number
749849|NCT00546871|Secondary|Rate of Temporally Associated AEs Per Infusion|Rate of AEs per infusion defined as the total number of all AEs that begin during infusion or within 72 hours of completion of an infusion (“temporally associated”) divided by the total number of infusions.|During Infusion or Within 72 Hours of Completion of Infusions|All participants who received any study drug||AEs per infusion|Participants||Number
749850|NCT00546871|Secondary|Annual Rate of Acute Serious Bacterial Infections During IV and SC Treatment (FSDS)|Annual rate of validated acute serious bacterial infections was calculated using a Poisson model to account for the different lengths of observation per subject using SAS V9.1.3 procedure GENMOD with an allowance for overdispersion by the deviance method.|Throughout the study, 1 year and 9 months|Full Safety Data Set (All study participants who received any infusions)||Estimated infections/year|||Number
749851|NCT00546871|Secondary|Annual Infection Rates During Treatment|Annual rate of all infections calculated using a Poisson model to account for different lengths of observation per subject using SAS V9.1.3 procedure GENMOD with allowance for overdispersion by deviance method. Point estimates and likelihood-ratio based 95% confidence intervals were provided. Infections as included in analysis comprised all reported AEs that were coded to the Medical Dictionary for Regulatory Activities (MedDRA) system organ class (SOC) of infections and infestations, described as an infection by investigator, or for which anti-infective medication was prescribed.|Throughout the study, 1 year and 9 months|Full safety data set (all participants who received any study drug)||Estimated infections per year||95% Confidence Interval|Mean
749852|NCT00546871|Secondary|Number of Anti-Measles Antibody Titers That Were Below or Above the Protective Titer Level|Antibody Titers That Were Below or Above the Protective Titer Level of >1:8 for IV and SC Treatment in Study Parts 1, 2, 3a and 3b. Participants had multiple anti-measles antibody titers measured during the study.|Baseline; at each 3 or 4-week study visit in Study Part 1; at Visits 1, 5, and 9 in Study Part 2; at Visit 1 in Study Part 3a; at Visits 1, 5, and 9 in Study Part 3b; at Visit 1 in the Study Extension Part; and at the end-of-study evaluation|All study participants||Antibody titers|Participants||Number
749853|NCT00546871|Secondary|Trough Levels of Antibody to Tetanus In All Study Participants|Trough levels for IV and SC Treatment in Study Parts 1, 2, 3a and 3b.|Baseline; at each 3 or 4-week study visit in Study Part 1; at Visits 1, 5, and 9 in Study Part 2; at Visit 1 in Study Part 3a; at Visits 1, 5, and 9 in Study Part 3b; at Visit 1 in the Study Extension Part; and at the end-of-study evaluation|All participants with specific antibody test results||IU/mL||95% Confidence Interval|Median
749854|NCT00546871|Primary|Percentage of Participants in Full Safety Data Set (FSDS) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped|Ability to tolerate IGIV, 10% administered IV or SC. Measured as the percentage of participants for which the infusion rate was reduced at any infusion and/or the infusion was interrupted or stopped for (i) any reason and (ii) for tolerability concerns or AEs|Throughout study (1 year and 9 months)|Full safety data set (all participants who received any study drug)||Percentage of Participants|||Number
749855|NCT00546871|Secondary|Trough Levels of Antibody to Hepatitis B in All Study Participants|Trough levels for IV and SC Treatment in Study Parts 1, 2, 3a and 3b.|Baseline; at each 3 or 4-week study visit in Study Part 1; at Visits 1, 5, and 9 in Study Part 2; at Visit 1 in Study Part 3a; at Visits 1, 5, and 9 in Study Part 3b; at Visit 1 in the Study Extension Part; and at the end-of-study evaluation|All participants with specific antibody test results||mIU/mL||95% Confidence Interval|Median
749856|NCT00546871|Secondary|Trough Levels of Antibody to Haemophilus Influenzae In All Study Participants|Trough levels for IV and SC Treatment in Study Parts 1, 2, 3a and 3b.|Baseline; at each 3 or 4-week study visit in Study Part 1; at Visits 1, 5, and 9 in Study Part 2; at Visit 1 in Study Part 3a; at Visits 1, 5, and 9 in Study Part 3b; at Visit 1 in the Study Extension Part; and at the end-of-study evaluation|All participants with specific antibody test results||µg/mL||95% Confidence Interval|Median
749857|NCT00546871|Secondary|Trough Levels of IgG After Administration of IGIV, 10%, in Participants 12 Years and Older|"Part 1: IgG trough levels measured at each IV infusion day (every 3rd or 4th week depending on schedule/frequency of participants for a total of 12 weeks)
Part 2: IgG trough levels measured at weeks 1, 5 and 9 (of a total of 12 weeks)
Part 3a: IgG trough levels measured at weeks 1 and 5 (of a total of 6 weeks)
Part 3b: IgG trough levels measured at weeks 1, 5, 9 and 12 (of a total of 12 weeks)"|Baseline; at each 3 or 4-week study visit in Study Part 1; at Visits 1, 5, and 9 in Study Part 2; at Visits 1, and 5 in Study Part 3a; at Visits 1, 5, and 9 in Study Part 3b; and at the end-of-study evaluation|Full safety data set (all participants who received any study drug), 12 Years and Older||g/L||95% Confidence Interval|Median
750787|NCT00553631|Primary|Mean Change From Baseline to Month 9 in Hemoglobin (Hgb) Concentration for Each Treatment Group.||Baseline to Month 9|Intent-to-treat (ITT) population comprised of all randomized participants who received at least 1 full or partial dose of study drug.||gram per deciliter (g/dl)||Standard Error|Mean
749858|NCT00546871|Secondary|Study Part 3B: Weight-adjusted Clearance|Computed as weight-adjusted dose divided by total AUC|Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion.|"Participants for whom the following PK measurements are available:
pre-infusion and the Day 7 measurements
≥2 measurements for Days 1, 3, and 5"||mL/kg/day||95% Confidence Interval|Median
749859|NCT00546871|Secondary|Study Part 3B: Area Under the Curve (AUC)|The AUC between adjacent infusions was calculated by the trapezoidal rule. Linear interpolation/extrapolation was used to calculate the AUC for the exact duration of the infusion intervals (21 or 28 days for IV administration and 7 days for SC administration). To allow for comparisons between Study Parts 1, 2 and 3b, AUC(0-τ) was standardized for the infusion intervals (3 or 4 weeks vs. 1 week).|Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion.|"Participants for whom the following PK measurements are available:
pre-infusion and the Day 7 measurements
≥2 measurements for Days 1, 3, and 5"||g*days/L||95% Confidence Interval|Median
749860|NCT00546871|Secondary|Study Part 3B: Minimum Plasma Concentration (C-min)|Minimal immune globulin concentration after infusion|Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion.|"Participants for whom the following PK measurements are available:
pre-infusion and the Day 7 measurements
≥2 measurements for Days 1, 3, and 5"||g/L||95% Confidence Interval|Median
749861|NCT00546871|Secondary|Study Part 3B: Time to Maximum Immune Globulin Concentration (T-max)|Time to reach C-max|Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion.|"Participants for whom the following PK measurements are available:
pre-infusion and the Day 7 measurements
≥2 measurements for Days 1, 3, and 5"||days||95% Confidence Interval|Median
749862|NCT00546871|Secondary|Study Part 3B: Maximum Plasma Concentration (C-max)|Maximal immune globulin concentration after infusion|Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion.|"Participants for whom the following PK measurements are available:
pre-infusion and the Day 7 measurements
≥2 measurements for Days 1, 3, and 5"||g/L||95% Confidence Interval|Median
749863|NCT00546871|Secondary|Study Part 2 (SC): Weight-adjusted Clearance|Computed as weight-adjusted dose divided by total AUC|Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion.|"Participants for whom the following PK measurements are available:
pre-infusion and the Day 7 measurements
≥2 measurements for Days 1, 3, and 5"||mL/kg/day||95% Confidence Interval|Median
749864|NCT00546871|Secondary|Study Part 2 (SC): Minimum Plasma Concentration (C-min)|Minimal immune globulin concentration after infusion|Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion.|"Participants for whom the following PK measurements are available:
pre-infusion and the Day 7 measurements
≥2 measurements for Days 1, 3, and 5"||g/L||95% Confidence Interval|Median
749865|NCT00546871|Secondary|Study Part 2 (SC): Time to Maximum Immune Globulin Concentration (T-max)|Time to reach C-max|Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion.|"Participants for whom the following PK measurements are available:
pre-infusion and the Day 7 measurements
≥2 measurements for Days 1, 3, and 5"||days||95% Confidence Interval|Median
749866|NCT00546871|Secondary|Study Part 2 (Subcutaneous (SC)): Maximum Plasma Concentration (C-max)|Maximal immune globulin concentration after infusion|Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion.|"Participants for whom the following PK measurements are available:
pre-infusion and the Day 7 measurements
≥2 measurements for Days 1, 3, and 5"||g/L||95% Confidence Interval|Median
749867|NCT00546871|Secondary|Study Part 1 (IV): Terminal Half-life|Computed from the regression slope in the terminal phase of the model (the slope is biphasic). Terminal half life is the time it takes for the plasma concentration or the amount of immunoglobulin in the body to be reduced by 50%during the terminal phase.|Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #3 starts) up to 28 days (+/-2 days) post-infusion.|"Participants for whom the following PK measurements are available:
pre-infusion and the 30-minute-post-infusion measurements
≥3 measurements for Days 1, 4, 9, 14, and 21 and/or 28
for the 3-week treatment schedule: Day 14 and/or the Day 21 measurement(s); for the 4-week treatment schedule: Day 21 and/or the Day 28 measurement(s)"||days||95% Confidence Interval|Median
749868|NCT00546871|Secondary|Study Part 1 (IV): Weight-adjusted Clearance|Computed as weight-adjusted dose divided by total AUC|Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #3 starts) up to 28 days (+/-2 days) post-infusion.|"Participants for whom the following PK measurements are available:
pre-infusion and the 30-minute-post-infusion measurements
≥3 measurements for Days 1, 4, 9, 14, and 21 and/or 28
for the 3-week treatment schedule: Day 14 and/or the Day 21 measurement(s); for the 4-week treatment schedule: Day 21 and/or the Day 28 measurement(s)"||mL/kg/day||95% Confidence Interval|Median
749869|NCT00546871|Secondary|Study Part 1 (IV): Minimum Plasma Concentration (C-min)|Minimal immune globulin concentration after infusion|Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #3 starts) up to 28 days (+/-2 days) post-infusion.|"Participants for whom the following PK measurements are available:
pre-infusion and the 30-minute-post-infusion measurements
≥3 measurements for Days 1, 4, 9, 14, and 21 and/or 28
for the 3-week treatment schedule: Day 14 and/or the Day 21 measurement(s); for the 4-week treatment schedule: Day 21 and/or the Day 28 measurement(s)"||g/L||95% Confidence Interval|Median
749870|NCT00546871|Secondary|Study Part 1 (IV): Maximum Plasma Concentration (C-max)|Maximal immune globulin concentration after infusion|Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #3 starts) up to 28 days (+/-2 days) post-infusion.|"Participants for whom the following PK measurements are available:
pre-infusion and the 30-minute-post-infusion measurements
≥3 measurements for Days 1, 4, 9, 14, and 21 and/or 28
for the 3-week treatment schedule: Day 14 and/or the Day 21 measurement(s); for the 4-week treatment schedule: Day 21 and/or the Day 28 measurement(s)"||g/L||95% Confidence Interval|Median
749871|NCT00546871|Primary|Bioavailability (Trough Levels) of IgG After Administration of IGIV, 10%, in Participants Aged 2 to <12 Years.|"Administration of IGIV, 10%:
Part 1 = IV administration (IV)
Parts 2, 3a, 3b = SC administration (SC)"|Baseline; at each 3 or 4-week study visit in Study Part 1; at Visits 1, 5, and 9 in Study Part 2; at Visits 1, and 5 in Study Part 3a; at Visits 1, 5, and 9 in Study Part 3b; and at the end-of-study evaluation|Full safety data set (all participants, aged 2 to <12 years who received any study drug)||g/L||95% Confidence Interval|Median
749872|NCT00546871|Primary|Ratio of Area Under the Concentration Curve (AUC 0-τ)/Week Following IV Administration to SC Administration of IGIV, 10% at an Adjusted/Individual Adapted Dose (Part 3b), Expressed as a Percentage|Expressed as (AUC_SC/AUC_IV) * 100|Week 12 (IV) and week 32 or 33 (SC)|Participants, ≥12 years, with PK data in terms of AUC[0-τ]/week following IV administration and SC administration of IGIV, 10% at an adjusted/individually adapted dose in Study Part 3b||percent||90% Confidence Interval|Number
749873|NCT00546884|Primary|Completion of Advance Directive|Completing an advance directive for the individuals health care when they are not able to direct it themselves|21 months|||Participants|||Count of Participants
749874|NCT00546897|Secondary|Plasma Proteins Via Proteomics|Proteomic analysis will be performed within the Siteman Cancer Center proteomics core on pre- and post-treatment plasma samples. This pilot proteomic study will identify candidate proteins of interest with altered expression after treatment with lenalidomide. This approach will provide an unbiased method to assess global changes in serum proteins following lenalidomide therapy.|Pre and post treatment|This outcome was not analyzed for either Cohort due to sample collection.|||||
749875|NCT00546897|Secondary|Gene Expression Profiles of Bone Marrow and Peripheral Blood|RNA will be made from total bone marrow cells for labeling and evaluations by RNA profiling. Cellular RNA and corresponding biotinylated cRNA targets will be prepared and hybridized with Affymetrix GeneChip® microarrays within the Multiplexed Gene Analysis SCC Core (Dr. Mark Watson, Director). Microarray data (and eventually corresponding gene sequence data) will be integrated an analyzed with state-of-the-art software packages. The pre- and post-treatment RNA profiling studies will be used as a discovery tool. Patterns of gene expression before and after lenalidomide therapy will be compared within each patient’s sample to identify genes with altered expression after lenalidomide therapy. In addition, supervised algorithms will be sued to identify genes that can potentially predict clinical outcome and response to lenalidomide therapy.|Pre and post treatment|This outcome measure was not analyzed for either Cohort due to sample collection.|||||
749876|NCT00546897|Secondary|Changes in NK Cell Number and Function|Peripheral blood mononuclear cells (PBMC) will be viably cryopreserved from patients at baseline (pre-therapy, newly diagnosed AML), during lenalidomide therapy, and posttherapy. Following sample collection, PBMC will be thawed, and flow cytometry will be performed to assess NK cell number (CD56+CD3-), subsets, and phenotype utilizing the Siteman Cancer Center Flow Cytometry / Cell Sorting Core. In addition, NK cell function will be assessed in flow based killing assays using PBMC (containing NK cells) as effectors and NK sensitive cell lines (K562) and/or autologous leukemic blasts as target cells. Thus, analyzing these parameters in patients before, during, and after therapy will provide a comprehensive evaluation of the ability of lenalidomide to modulate NK cells in patients in vivo.|Baseline, during therapy, and posttherapy|This outcome was not analyzed for either Cohort due to number of samples collected.|||||
749877|NCT00546897|Secondary|Duration of CR for Complete Responders|Duration of remission: Defined as the interval from the date complete remission is documented to the date of recurrence|2 years|Participants in Cohort 1 were not analyzed for duration of remission because it was determined the treatment design did not work. 8 out of 15 participants did not receive the 2 high dose lenalidomide cycles and 9 out of 15 participants did not receive any of the low dose lenalidomide cycles due to progressive disease.||months||Full Range|Median
749878|NCT00546897|Secondary|Relapse Free Survival (RFS) for Complete Responders|This is determined only for patients achieving a complete remission. Defined as the interval from the date of first documentation of a leukemia free state to date of recurrence or death due to any cause.|2 years|Participants in Cohort 1 were not analyzed for relapse free survival because it was determined the treatment design did not work. 8 out of 15 participants did not receive the 2 high dose lenalidomide cycles and 9 out of 15 participants did not receive any of the low dose lenalidomide cycles due to progressive disease.||months||95% Confidence Interval|Median
749879|NCT00546897|Secondary|Progression-free Survival|Progression-free survival (PFS) denotes the chances of staying free of disease progression for a group of individuals suffering from a cancer after a particular treatment. It is the percentage of individuals in the group whose disease is likely to remain stable (and not show signs of progression) after a specified duration of time. Progression-free survival rates are an indication of how effective a particular treatment is.|2 years|Participants in Cohort 1 were not analyzed for progression-free survival because it was determined the treatment design did not work. 8 out of 15 participants did not receive the 2 high dose lenalidomide cycles and 9 out of 15 participants did not receive any of the low dose lenalidomide cycles due to progressive disease.||months||95% Confidence Interval|Median
749880|NCT00546897|Secondary|Event Free Survival (EFS)|Event free survival: Defined as the interval from the date of first dose of study drug to date of treatment failure, recurrence, or death due to any cause.|2 years|Event free survival was not analyzed. Progression free survival was analyzed instead.|||||
749881|NCT00546897|Secondary|Overall Survival (OS)|Overall survival: Defined as the date of first dose of study drug to the date of death from any cause.|2 years|Participants in Cohort 1 were not analyzed for overall survival because it was determined the treatment design did not work. 8 out of 15 participants did not receive the 2 high dose lenalidomide cycles and 9 out of 15 participants did not receive any of the low dose lenalidomide cycles due to progressive disease.||months||95% Confidence Interval|Median
749882|NCT00546897|Secondary|Partial Remission Rate (PR)|Partial remission (PR): Requires that the criteria for complete remission be met with the following exceptions: decrease of >50% in the percentage of blasts to 5-25% in the BM aspirate. A value of < 5% blasts in BM with Auer rods is also considered a partial remission.|After 2 cycles of low dose lenalidomide (approximately Day 113 for Cohort 1 and approximately Day 104 for Cohort 2)|"9 out of 15 participants did not receive the two low dose cycles of lenalidomide in Cohort 1.
23 out of 33 participants did not receive the two low dose cycles of lenalidomide in Cohort 2."||participants|||Number
749883|NCT00546897|Secondary|CR With Complete Blood Counts (CRi) Rate|CRi = Defined as CR with the exception of neutropenia <1000/uL or thrombocytopenia <100,000/ul.|After 2 cycles of low dose lenalidomide (approximately Day 113 for Cohort 1 and approximately Day 104 for Cohort 2)|"9 out of 15 participants did not receive the two low dose cycles of lenalidomide in Cohort 1.
23 out of 33 participants did not receive the two low dose cycles of lenalidomide in Cohort 2."||participants|||Number
750788|NCT00553644|Secondary|Overall Survival|Overall survival (OS) is defined as the time from study entry until death. The median OS with 95% CI was estimated using the Kaplan-Meier method..|Assessed up to 6 years|||years||95% Confidence Interval|Median
749884|NCT00546897|Secondary|Cytogenetics CR Rate (CRc)|Cytogenetic complete remission (CRc): Only patients with an identified cytogenetic abnormality may receive this designation. Defines as a morphologic complete remission plus reversion to a normal karyotype (no clonal abnormalities detected in a minimum of 20 mitotic cells).|After 2 cycles of low dose lenalidomide (approximately Day 113 for Cohort 1 and approximately Day 104 for Cohort 2)|"9 out of 15 participants did not receive the two low dose cycles of lenalidomide in Cohort 1.
23 out of 33 participants did not receive the two low dose cycles of lenalidomide in Cohort 2."||participants|||Number
749885|NCT00546897|Secondary|Morphologic Complete Remission Rate (CRm)|CRm = Defined as morphologic leukemia-free state, including <5% blasts in BM aspirate with marrow spicules and a count of > 200 nucleated cells and no blasts with Auer rods, no persistent extramedullary disease, ANC > 1000/uL, platelet count >100,000/uL. Patient must be independent of transfusions for a minimum of 1 week before each marrow assessment. There is no duration requirement for this designation.|After 2 cycles of low dose lenalidomide (approximately Day 113 for Cohort 1 and approximately Day 104 for Cohort 2)|"9 out of 15 participants did not receive the two low dose cycles of lenalidomide in Cohort 1.
23 out of 33 participants did not receive the two low dose cycles of lenalidomide in Cohort 2."||participants|||Number
749886|NCT00546897|Secondary|Morphologic Leukemia Free State|Morphologic leukemia-free state: Defined as < 5% blasts on the BM aspirate with spicules and a count of > 200 nucleated cells and no blasts with Auer rods, and no persistent extramedullary disease.|After 2 cycles of low dose lenalidomide (approximately Day 113 for Cohort 1 and approximately Day 104 for Cohort 2)|"9 out of 15 participants did not receive the two low dose cycles of lenalidomide in Cohort 1.
23 out of 33 participants did not receive the two low dose cycles of lenalidomide in Cohort 2."||participants|||Number
749887|NCT00546897|Secondary|Response Rate (RR)|"RR = as patients obtaining any response (CRm + CRc +CRi + PR).
CRm = Defined as morphologic leukemia-free state, including <5% blasts in BM aspirate with marrow spicules and a count of > 200 nucleated cells and no blasts with Auer rods, no persistent extramedullary disease, ANC > 1000/uL, platelet count > 100,000/uL. Patient must be independent of transfusions for a minimum of 1 week before each marrow assessment. There is no duration requirement for this designation.
CRc = Cytogenetic complete remission (CRc): Only patients with an identified cytogenetic abnormality may receive this designation. Defines as a morphologic complete remission plus reversion to a normal karyotype (no clonal abnormalities detected in a minimum of 20 mitotic cells).
Morphologic complete remission with incomplete blood count recovery (CRi): Defined as CR with the exception of neutropenia <1000/uL or thrombocytopenia <100,000/ul.
Partial remission (PR): Requires"|After 2 cycles of low dose lenalidomide (approximately Day 113 for Cohort 1 and approximately Day 104 for Cohort 2)|"9 out of 15 participants did not receive the two low dose cycles of lenalidomide in Cohort 1.
23 out of 33 participants did not receive the two low dose cycles of lenalidomide in Cohort 2."||participants|||Number
749888|NCT00546897|Secondary|Safety and Tolerability (Removal From Study Due to Adverse Events)|Toxicity will be scored using CTCAE Version 3.0 for toxicity and adverse event reporting|4 weeks after last dose of study drug [median duration of therapy was 65 days (range, 3-413 days)]|||participants|||Number
749889|NCT00546897|Primary|Complete Remission Rate (CRm + CRi + CRc)|"CRm = Defined as morphologic leukemia-free state, including <5% blasts in BM aspirate with marrow spicules and a count of > 200 nucleated cells and no blasts with Auer rods, no persistent extramedullary disease, ANC > 1000/uL, platelet count >100,000/uL. Patient must be independent of transfusions for a minimum of 1 week before each marrow assessment. There is no duration requirement for this designation.
CRi = Defined as CR with the exception of neutropenia <1000/uL or thrombocytopenia <100,000/ul.
Cytogenetic complete remission (CRc): Only patients with an identified cytogenetic abnormality may receive this designation. Defines as a morphologic complete remission plus reversion to a normal karyotype (no clonal abnormalities detected in a minimum of 20 mitotic cells)."|After 2 cycles of low dose lenalidomide (approximately Day 113 for Cohort 1 and approximately Day 104 for Cohort 2)|"9 out of 15 participants did not receive the two low dose cycles of lenalidomide in Cohort 1.
23 out of 33 participants did not receive the two low dose cycles of lenalidomide in Cohort 2."||participants|||Number
749890|NCT00546910|Primary|Change From Baseline cb CPT Variable: Other (Includes Error Rate [ER] and Multi Response [MR]) Q-scores At Week 8|Computer test. Patient is to press button if target appears, but not at non-target. Other variables during test: ER=percent of overall incorrect responses (CE and OE); MR=percent of multiple responses per presentation of target (patient responds more than once to target). Results are converted to Q-scores (age and sex-adjusted normalized scores with a mean=0 and standard deviation=1 in the general population, expressing the probability determined by the Gamma function in terms of standard deviation of Gaussian density). Higher scores reflect more severe symptoms.|Baseline, 8 weeks|Full analysis population (N=125) including all randomized participants taking at least one dose of study medication.||Q-scores||Standard Deviation|Mean
749891|NCT00546910|Primary|Change From Baseline cb CPT Variable: Impulsivity (Includes Commission Error [CE], Anticipatory Response [AR]) Q-scores At Week 8|Computer test. Patient is to press button if target appears, but not at non-target. Impulsivity variables during test: CE=percent of response to non-target; ANT=percent of responses prior to target presentation. Results are converted to Q-scores (age and sex-adjusted normalized scores with a mean=0 and standard deviation=1 in the general population, expressing the probability determined by the Gamma function in terms of standard deviation of Gaussian density). Higher scores reflect more severe symptoms.|Baseline, 8 weeks|Full analysis population (N=125) including all randomized participants taking at least one dose of study medication.||Q-scores||Standard Deviation|Mean
749892|NCT00546910|Primary|Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8|Computer test. Patient is to press button if target appears, but not at non-target. Inattention test variables: mRT=average time (ms) from target presentation to response; RTV=standard deviation of mRT; nVRT=RTV expressed in terms of RT (variation as a percent of mean value); OE= percent of omitted targets. Results are converted to Q-scores (age and sex-adjusted normalized scores with a mean=0 and SD=1 in the general population, expressing the probability determined by the Gamma function in terms of SD of Gaussian density). Higher scores reflect more severe symptoms.|Baseline, 8 weeks|Full analysis population (N=125) including all randomized participants taking at least one dose of study medication.||Q-scores||Standard Deviation|Mean
757494|NCT00608491|Secondary|Change in Blood Bicarbonate Level||Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mEq/L||Standard Deviation|Mean
749893|NCT00546910|Secondary|Change From Baseline Weekly Rating Of Evening and Morning Behavior-Revised-Investigator Rated, Total and Subscores at Week 8|Weekly Rating Of Evening & Morning Behavior-Revised-Investigator Rated (WREMB-R-Inv) measures the level of difficulty of 11 common morning or evening behaviors (e.g. getting out of bed, doing homework, sitting through dinner). Possible scores for each item range from 0 (no difficulty) to 3 (a lot of difficulty) with a Total score (maximum score=33), Morning subscore (maximum score=9), Evening subscore (maximum score=24), and Item 11 score which pertains to degree of difficulty falling asleep (maximum score=3).|Baseline, 8 weeks|Full analysis population (N=125) including all randomized participants taking at least one dose of study medication.||units on a scale||Standard Deviation|Mean
749894|NCT00546910|Secondary|Change From Baseline Clinical Global Impressions-Severity of ADHD (CGI-S-ADHD) Score at Week 8|CGI-S-ADHD measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).|Baseline, 8 weeks|Full analysis population (N=125) including all randomized participants taking at least one dose of study medication.||units on a scale||Standard Deviation|Mean
749895|NCT00546910|Secondary|Change From Baseline Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered And Scored (ADHDRS-IV-Parent:Inv) Total Score At Week 8|Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54.|Baseline, 8 weeks|Full analysis population (N=125) including all randomized participants taking at least one dose of study medication.||units on a scale||Standard Deviation|Mean
749896|NCT00546910|Primary|Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8|Infra-red camera tracks movement of head reflector on patient performing computer test. Hyperactivity test variables: TA=percent time patient moved>1 centimeter (cm)/second; DIS=path of movement (m); AR=total area (cm2) of movements; ME=number of position changes>1 mm; MS=degree (percent) of directional changes. Results are converted to Q-scores (age and sex-adjusted normalized scores with a mean=0 and standard deviation (SD)=1 in general population, expressing the probability determined by the Gamma function in terms of SD of Gaussian density). Higher scores reflect more severe symptoms.|Baseline, 8 weeks (W8)|Full analysis population (N=125) including all randomized participants taking at least one dose of study medication.||Q-scores||Standard Deviation|Mean
749897|NCT00547118|Secondary|To Examine the Efficacy of Rimonabant for Patient Perceived Health Outcomes and Quality of Life (Secondary Outcome)||End of study||||||
749898|NCT00547118|Primary|To Examine the Efficacy of Rimonabant for Neurocognitive Impairments in People With Schizophrenia Treated With Second-generation Antipsychotics|The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) is a brief, individually administered test designed to evaluate neuropsychological status of adults, ages 20-89. The 12 subtests measure attention, language, visuospatial/constructional abilities, and immediate and delayed memory. The raw scores from the subtests are scaled together to create index scores, and these are summed for conversion to a total scale score. Higher score equals a better outcome. The total index score range for the RBANS is 40-160.|Baseline and End of study|14 (R n=7, P n=7) completed baseline and End Of Study (EOS), 16 wk. Neurocognitive assessments (i.e. RBANS); 1 P pt. failed to complete the other EOS neurocognitive tests. 5 R pts. and 4 P pts. completed the 16-wk. treatment phase; the other 2 R pts. completed 11 and 13 wks. and 3 P pts. completed 13 (n=2) and 15 wks. (n=1).||units on a scale||Standard Deviation|Mean
749899|NCT00547118|Primary|To Examine the Effects of Rimonabant on Food Satiety in People With Schizophrenia||End of study||||||
749900|NCT00547118|Primary|To Test the Effect of Rimonabant on Cigarette Smoking, Nicotine Dependence and Nicotine Craving in People With Schizophrenia||End of study||||||
749901|NCT00547118|Primary|To Examine the Safety and Tolerability of Rimonabant as an Adjunctive Agent for Decreasing Weight and Metabolic Risk in People With Schizophrenia||End of study||||||
749902|NCT00547118|Primary|To Examine the Efficacy of Rimonabant in Decreasing Weight and Metabolic Parameters/Cardiovascular Disease Risk in People With Schizophrenia Receiving Second Generation Antipsychotics||End of study||||||
749903|NCT00547157|Secondary|CRR by 6 Months - Central|CRR is Complete Response Rate. Tumor assessments are based on central review of scans uisng a modification of the WHO criteria. Complete Response (CR) is defined as disappearance of all index lesions.|From randomization till 6 months|Evaluable for Central Tumor Response Analysis Set: the subset of subjects in the Efficacy Analysis Set with at least one bi-dimensionally measurable leasion at baseline using a modification of the WHO criteria per blinded central review.||Proportion of Participants||95% Confidence Interval|Number
749904|NCT00547157|Secondary|ORR by 6 Months - Central|ORR is Objective Response Rate. Tumor assessments are based on central review of scans uisng a modification of the WHO criteria. Complete or partial response is considered as objective response.|From randomization to 6 months|Evaluable for Central Tumor Response Analysis Set: the subset of subjects in the Efficacy Analysis Set with at least one bi-dimensionally measurable leasion at baseline using a modification of the WHO criteria per blinded central review.||Proporation of Participants||95% Confidence Interval|Number
749905|NCT00547157|Secondary|Overall Survival|Time from first dose date to death|maximum follow up time 46.2 months|Efficacy Analysis Set||months||95% Confidence Interval|Median
749906|NCT00547157|Secondary|Progression-free Survival|Time from first dose date till disease progression or death|maximum follow up time 46.2 months|Efficacy analysis set||months||95% Confidence Interval|Median
749907|NCT00547157|Secondary|Duration of Local Regional Control|Time from study day 1 to the date of first local-regional failure or to death due to any cause (whichever occurs first)|maximum follow up time 46.2 months|Efficacy Analysis Set||months||95% Confidence Interval|Median
749908|NCT00547157|Primary|Local Regional Control Rate at 2 Years|Kaplan-Meier estimate of Local regional control rate at 2 years. Local regional control rate will be measured according to the investigator’s assessment of disease status based on all available data (ie, from clinical examination, radiologic assessments, pathology reports, and autopsy reports).|from study day 1 to 2 years|Efficacy Analysis Set||Proportion of Participants||95% Confidence Interval|Number
752638|NCT00561600|Secondary|Analysis of Metal Ion Release - Serum Cobalt|Serum Cobalt|4 months post-operative|Metal ion sub-study was limited to two sites. All participants with available data are presented below.||ug/L||Full Range|Median
749909|NCT00547365|Primary|Clinical Response of Patients With Cardiac-dominant AL Amyloidosis Given Human Immune Globulin Intravenous (IGIV)|Positive clinical response was defined by improvement in heart function in participating patients with cardiac-dominant AL amyloidosis, as demonstrated by increased serum anti-fibril immunoglobulin G (IgG) antibody levels and reduction (or no evident progression) in amyloid burden.|Up to 1 year|Two of ten patients with AL cardiac involvement who received IGIV infusions were analyzed (other eight individuals were removed from study before completion due to death/conditions unrelated to IGIV, loss to follow-up, or physician decision).||participants with positive response|||Number
749910|NCT00547365|Primary|Tolerance for Human Immune Globulin Intravenous (IGIV), as Reflected by the Number and Severity of Toxicity Incidents Occurring in Ten Patients Receiving at Least One Infusion of IGIV.||Up to 1 year|All patients who had at least one infusion of human immune globulin intravenous.||events|||Number
749911|NCT00547456|Primary|Demonstration of Improvement in Systemic Inflammation, Sleep Quality and Health Related Quality of Life With Nocturnal Oxygen Supplementation.||4 weeks|The assay used did not work, as a result, no data for any Outcome Measures was collected. The trial is closed and completed.|||||
749912|NCT00547521|Secondary|Number of Participants With MAs in Urinalysis During the LTE Period: Protein, Glucose, Blood, Leukocyte Esterase, Red Blood Cells (RBC) and White Blood Cells (WBC) - All Treated Participants in LTE Study|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following definitions specify the criteria for MAs in urinalysis: protein, glucose, blood, leukocyte esterase, RBC, WBC: >= 2+ (or, if value >= 4, or if pre-Rx value = 0 or 0.5, then >= 2x or if pre-Rx value =1, then >= 3, or if pre-Rx = 2 or 3, then >= 4).|Continuously from start of LTE Study up to 56 days post the last dose|Participants who received at least 1 dose of abatacept in the LTE Study and who had specified laboratory values up to 56 days post the last dose of abatacept in the LTE period, were evaluated. n=number of participants evaluated.||participants|||Number
749913|NCT00547521|Secondary|Number of Participants With MAs in Serum Chemistry (Electrolytes, Glucose, Protein, and Metabolite) During the LTE Period - All Treated Participants in LTE Study|Sodium (serum):<0.95 * LLN or >1.05 * ULN (if pre-Rx < LLN, then <0.95 * pre-Rx or >1.05 * ULN. If pre-Rx > ULN, then >0.95 * pre-Rx or < ULN); potassium (serum):<0.9 * LLN or >1.1 * ULN (if pre-Rx < LLN, then <0.9 * pre-Rx or > ULN; chloride (serum),protein (total):<0.9 * LLN or >1.1 8 ULN (if pre-Rx < LLN, then <0.9 * pre-Rx or > ULN. If pre-Rx > ULN, then >1.1 * pre-Rx or < LLN); calcium (total): <0.8 * LLN or >1.2 * ULN (if pre-Rx < LLN, then <0.9 * pre-Rx or > ULN. If pre-Rx > ULN, then >0.75 * pre-Rx or < ULN); phosphorous (inorganic):<0.75 * LLN or >1.25 * ULN (if pre-Rx < ULN, then <0.67 * pre-Rx or < ULN. If pre-Rx > ULN, then >1.33 * re-Rx or <LLN); glucose (serum): <65 mg/dL or >220 mg/dL; Glucose (fasting serum): <0.8 * LLN or >1.5 ULN (if pre-Rx <LLN, then <2.0 * pre-Rx or >ULN; albumin: <0.9 * LLN (if pre-Rx < LLN, then <0.75 * pre-Rx); uric acid: >1.5 * ULN (if pre-Rx > ULN, then >2.0 * pre-Rx).|Continuously from start of LTE Study up to 56 days post the last dose|Participants who received at least 1 dose of abatacept in the LTE Study and who had specified laboratory values up to 56 days post the last dose of abatacept in the LTE study, were summarized. n=number of participants evaluated.||participants|||Number
749914|NCT00547521|Secondary|Number of Participants With MAs in Serum Chemistry (Liver and Kidney Function) During the LTE Period - All Treated Participants in LTE Study|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Bilirubin (Total), G-Glutamyl Transferase (G-GT), Blood Urea Nitrogen (BUN) and Creatinine MA criteria: ALP: >2.0 * ULN (if pre-Rx > ULN, then >3 * pre-Rx); AST, ALT: > 3 * ULN (if pre-Rx > ULN, then > 4 * pre-Rx); bilirubin (total): >2 * ULN, or if pre Rx > ULN then >4 * Pre Rx; BUN : >2 * pre Rx; GGT : >2 * ULN, or if pre Rx > ULN then >3 * pre Rx; creatinine: >1.5 * pre-Rx.|Continuously from start of LTE Study up to 56 days post the last dose|Participants who received at least 1 dose of abatacept in the LTE Study and with specified laboratory values up to 56 days post the last dose of abatacept in the LTE Study, were evaluated. n=number of participants evaluated.||participants|||Number
749915|NCT00547521|Secondary|Number of Participants With Marked Abnormalities (MAs) in Hematology During the LTE Period - All Treated Participants in LTE Study|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following hematology MA definitions specify the criteria for the data presented. Hemoglobin: >3 g/dL decrease from pre-treatment (pre Rx); hematocrit: <0.75 * pre-Rx value; platelet count: <0.67 * (LLN -lower limit of normal) (or, if pre-Rx value <LLN, then <0.5 * pre-Rx value and <100,000/mm^3); leukocytes: <0.75 * LLN or >1.25 * ULN (or, if pre-Rx value <LLN, then <0.8 * pre-Rx or >(ULN -upper limit of normal) ; erythrocytes: <0.75 * pre Rx. Neutrophils + bands (absolute): <1.00 * 10^3cells/microlitre (uL); lymphocytes (absolute): <0.75 * 10^3 cells/uL or >7.50 * 10^3 cells/uL; monocytes (absolute): >2.00 * 10^3 cells/uL; basophils (absolute): >0.40 * 10^3 cells/uL; eosinophils (absolute): >0.75 * 10^3 cells/uL.|Continuously from start of LTE Study up to 56 days post the last dose|Participants who received at least 1 dose of abatacept in the LTE Study and who had specified laboratory values up to 56 days post the last dose of abatacept in the LTE Study, were evaluated. n=number of participants evaluated.||participants|||Number
749916|NCT00547521|Secondary|Number of Participants With AEs of Special Interest During the LTE Study - All Treated Participants in LTE Study|An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition (even if not caused by the study drug). For this study, AEs of particular importance were associated with the use of immunomodulatory agents: infections, autoimmune disorders, malignancies, and injection reaction AEs (systemic AEs occurring within 24 hours of SC injection and local injection site reactions) were recorded.|Continuously from start of LTE Study up to 56 days post the last dose|Participants who received at least 1 dose of abatacept in the LTE Study and who had events up to 56 days post the last dose of abatacept in the LTE Study, were evaluated.||participants|||Number
749943|NCT00547521|Secondary|Number of Participants With Clinically Meaningful Improvement at End of 4-month (Day 113) of the ST Study|A clinically meaningful improvement is defined as a greater than or equal to 1.2 reduction in DAS28-CRP score from baseline.|Day 113.|All treated participants included those participants who received at least 1 dose of the study medication (abatacept) in the ST period with baseline and post-baseline values.||participants|||Number
750789|NCT00553644|Secondary|Time to Progression|Time to progression (TTP) is defined as the time from study entry until progression or death due to any cause. The median TTP with 95% CI was estimated using the Kaplan-Meier method.|Assessed up to 6 years|||years||95% Confidence Interval|Median
749917|NCT00547521|Secondary|Number of Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs), or Discontinued Due to AEs and/or SAEs During the LTE Period - All Treated Participants in LTE Study|AEs: any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Drug-related AEs/SAEs are those events with a relationship to the study therapy of certain; probable; possible; or missing.|Continuously from start of LTE Study up to 56 days post the last dose|Participants who received at least 1 dose of abatacept in the LTE Study and who had events up to 56 days post the last dose of abatacept in the LTE period, were evaluated. Includes all deaths reported during the LTE including those that occurred greater than 56 days after the last dose.||participants|||Number
749918|NCT00547521|Secondary|Number of Participants in DAS 28-CRP Remission and Low Disease Activity (LDA) in the LTE Study - Abatacept Monotherapy Subgroup|Remission was defined as DAS 28-CRP < 2.6 and LDA was defined as DAS 28-CRP <= 3.2. End of ST Study was Day 113. Abatacept Monotherapy Subgroup was defined as those participants who received as at least 1 dose of abatacept and did not receive MTX in the ST and LTE Studies.|Day 113, Day 1345|Participants who received abatacept monotherapy (at least 1 dose of abatacept and no MTX) in the ST and LTE Studies, and who had values at Day 113 and Day 1345, were evaluated.||participants|||Number
749919|NCT00547521|Secondary|Change From Baseline in DAS28-CRP Score and Physical Function (HAQ-DI) Score in the LTE Study - Abatacept Monotherapy Subgroup|Abatacept Monotherapy Subgroup consisted of participants who received SC abatacept and did not receive MTX in the ST and LTE Studies. DAS28-CRP: continuous variable which is a composite of 4 variables:number of tender joints out of 28, number of swollen joints out of 28, C-reactive protein (CRP) in mg/L and self assessment of disease activity measure on a VAS of 100mm. DAS 28 = 0.56 * sqrt(tender28) + 0.28 * sqrt(swollen28) + 0.36 * ln(CRP+1) + 0.014 * VAS + 0.96. HAQ-DI includes 20 questions assessing physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities on a 4-point scale: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty and 3 = unable to do. Higher scores indicate greater dysfunction. The score sums worst scores in each domain and divides by the number of domains answered. Baseline was Day 1 of Short Term Study. Day 113 was the last day of the Short Term Study.|Baseline, Day 113, Day 1345|Participants who received abatacept monotherapy (at least 1 dose of abatacept and no MTX) in the ST and LTE Studies and who had values at Baseline, Day 113, and Day 1345, were evaluated.||units on a scale||Standard Error|Mean
749920|NCT00547521|Secondary|Number of Participants With Negative Status for RF up to 7 Days After Last Dose of Abatacept in the LTE Period - All Treated Participants in LTE Study|RF is an autoantibody that is usually present in the serum of people with rheumatoid arthritis. The cut-point value for seroconversion was 15 IU/mL (>= 15 IU/mL resulted in a positive result).|Continuously from start of LTE period up to 7 days post the last dose|Participants who received at least 1 dose of abatacept in the LTE and who had an RF test result up to 7 days post the last dose of abatacept in the LTE study, were evaluated.||participants|||Number
749921|NCT00547521|Secondary|Number of Participants With HAQ Responses in the LTE Study - All Treated Participants in the LTE STudy|HAQ response was defined as an improvement of at least 0.3 units from baseline in the HAQ Disability Index (HAQ DI). Baseline was Day 1 of the ST Study and Day 113 was the last day of the ST Study.|Baseline, Day 113, Day 1345|Participants who received at least 1 dose of abatacept in the LTE study and who had values at Baseline, Day 113 and Day 1345, were evaluated.||participants|||Number
749922|NCT00547521|Secondary|Change From Baseline in HAQ-DI in the LTE Study - All Treated Participants in LTE Study|HAQ-DI takes into account participant’s use of aids or devices or assistance in scoring algorithm for a disability category. The questionnaire includes 20 questions assessing physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The questions are evaluated on a 4-point scale: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty and 3 = unable to do. Higher scores indicate greater dysfunction. The score is calculated by summing worst scores in each domain and dividing by the number of domains answered. Baseline was Day 1 in the ST Study and Day 113 was the last day of the ST Study.|Baseline, Day 113, Day 1345|Participants who received at least 1 dose of abatacept in the LTE study and who had values at Baseline, Day 113 and Day 1345, were evaluated.||units on a scale||95% Confidence Interval|Mean
749923|NCT00547521|Secondary|Number of Participants in DAS28-CRP Remission and Number of Participants With Low Disease Activity (LDA) in the LTE Study - All Treated Participants in the LTE|DAS28-CRP remission was defined as DAS28-CRP less than 2.6 and LDA was defined as DAS28-CRP less than, equal to 3.2. End of ST Study was Day 113.|Day 113, Day 1345|Participants who received at least 1 dose of abatacept in the LTE study and who had values at Day 113 and Day 1345, were evaluated.||participants|||Number
749924|NCT00547521|Secondary|Number of Participants With Clinically Meaningful Improvement From Baseline in the LTE Study - All Treated Participants in LTE Study|A clinically meaningful improvement is defined as a greater than or equal to 1.2 reduction in DAS28-CRP score from baseline. Baseline was Day 1 of the ST Study. Day 113 was the end of the ST Study.|Baseline, Day 113, Day 1345|Participants who received at least 1 dose of abatacept in the LTE Study and who had values at Baseline, Day 113 and Day 1345, were evaluated.||participants|||Number
749925|NCT00547521|Secondary|Change From Baseline in DAS28-CRP Score in the LTE Study - All Treated Participants in LTE Study|DAS28-CRP is a continuous variable which is a composite of 4 variables: the number of tender joints out of 28, the number of swollen joints out of 28, C-reactive protein (CRP) in milligrams/Liter (mg/L) and subject assessment of disease activity measure on a VAS of 100mm. DAS 28 = 0.56 * sqrt(tender28) + 0.28 * sqrt(swollen28) + 0.36 * ln(CRP+1) + 0.014 * VAS + 0.96. Baseline was Day 1 of the ST Study; Day 113 was the end of the ST Study.|Baseline, Day 113, Day 1345|Participants who received at least 1 dose of abatacept in the LTE Study and who had DAS28-CRP values at Baseline, Day 113 and Day 1345, were evaluated.||Units on a scale||95% Confidence Interval|Mean
749952|NCT00547534|Secondary|Overall Response Rate (ORR)|Overall response rate (ORR)to protocol treatment - Partial response, Complete response, etc.|Two years|||Lymphoma Subjects|||Number
749953|NCT00547534|Secondary|Toxicity of Drug Combination in the Subjects||Two years|||Lymphoma Subjects|||Number
757495|NCT00608491|Secondary|Change in Blood Urea Nitrogen/Urea||Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mg/dL||Standard Deviation|Mean
749926|NCT00547521|Secondary|Number of Participants With Abatacept Induced Antibody Responses Over Time During the LTE Study (ECL Method) - All Treated Participants in LTE Study|The Meso-Scale Discovery (MSD) electrochemiluminescence (ECL) assay method is a validated, sensitive assay technique used to analyze presence of abatacept-specific antibodies in serum. It is more sensitive and has a higher drug tolerance than ELISA method. For the anti-abatacept antibody ECL (MSD) assay, a sample was considered seropositive if it had a titer of 10 or greater and if immunodepletion was observed with abatacept, or abatacept and CTLA4-T. Those responses that were not positive in the initial screen or were not confirmed to be positive based on immunodepletion were reported as seronegative and were assigned a value of < 10. Antibody responses included CTLA4 and possibly immune globulin (IG), IG and/or junction region.|Days 197, 281, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1177, 1261, 1345, 1457, 1541, 1625, 1709, 1821, 1989, days post dose: 28, 56, 85, 168|Participants who received at least 1 dose of abatacept in the LTE Study and who had values at each specified timepoint, were evaluated.||participants|||Number
749927|NCT00547521|Secondary|Minimum Plasma Concentration (Cmin) at Each Visit During the 4 Month Treatment Period of the ST Study|Cmin serum abatacept concentration was obtained directly from the concentration-time data.|Days 1, 15, 29, 43, 57, 85 and 113.|All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period. n=those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.||microgram/mL||Full Range|Geometric Mean
749928|NCT00547521|Secondary|Number of Participants With Clinically Meaningful Vital Signs During the ST Study|Vital signs measurements (including seated blood pressure, heart rate and temperature) were recorded. The investigator used his/her clinical judgment to decide whether or not abnormalities in vital signs/physical examination were clinically meaningful.|At screening and on days 1,15,29,43, 57, 85 and 113.|All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period.||participants|||Number
749929|NCT00547521|Secondary|Number of Participants With Anti-double Stranded DNA (dsDNA) Category at Day 113 of the ST Study|Anti-dsDNA antibody status was categorized as negative or positive based upon assay-specific numeric cut-off values.|Day 113.|All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period.||participants|||Number
749930|NCT00547521|Secondary|Number of Participants With Anti-nuclear Antibody (ANA) Category at Day 113 of the ST Study|ANA status was categorized as negative or positive corresponding to the following dilutions: less than 1:160 and greater than equal to 1:160.|Day 113.|All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period.||participants|||Number
749931|NCT00547521|Secondary|Number of Participants With MAs in Urinalysis During the ST Study: Protein, Glucose, Blood, Leukocyte Esterase, Red Blood Cells (RBC) and White Blood Cells (WBC)|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following definitions specify the criteria for MAs in urinalysis: protein, glucose, blood, leukocyte esterase, RBC, WBC: >= 2+ (or, if value >= 4, or if pre-Rx value = 0 or 0.5, then >= 2x or if pre-Rx value =1, then >= 3, or if pre-Rx = 2 or 3, then >= 4).|Continuously from start of ST period up to 56 days post the last dose in the short-term period or start of the long-term period, whichever occurred first.|All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period, n= number of participants evaluated for this measure.||participants|||Number
749932|NCT00547521|Secondary|Number of Participants With MAs in Serum Chemistry During the ST Study: Glucose (Fasting Serum), Albumin, Glucose (Serum), Phosphorous (Inorganic) and Uric Acid|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria. Glucose (fasting serum): <0.8 * LLN or >1.5 ULN (if pre-Rx <LLN, then <2.0 * pre-Rx or >ULN; albumin: <0.9 * LLN (if pre-Rx < LLN, then <0.75 * pre-Rx); uric acid: >1.5 * ULN (if pre-Rx > ULN, then >2.0 * pre-Rx); phosphorous (inorganic):<0.75 * LLN or >1.25 * ULN (if pre-Rx < ULN, then <0.67 * pre-Rx or < ULN. If pre-Rx > ULN, then >1.33 * re-Rx or < LLN); glucose (serum): <65 mg/dL or >220 mg/dL.|Continuously from start of ST period up to 56 days post the last dose in the short-term period or start of the long-term period, whichever occurred first.|All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period, n= number of participants evaluated for this measure.||participants|||Number
749933|NCT00547521|Secondary|Number of Participants With MAs in Serum Chemistry During the ST Study: Creatinine, Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total) and Protein (Total)|MAs= laboratory measurements marked as abnormal: creatinine: >1.5 * pre-Rx; sodium (serum):<0.95 * LLN or >1.05 * ULN (if pre-Rx < LLN, then <0.95 * pre-Rx or >1.05 * ULN. If pre-Rx > ULN, then >0.95 * pre-Rx or < ULN); potassium (serum):<0.9 * LLN or >1.1 * ULN (if pre-Rx < LLN, then <0.9 * pre-Rx or > ULN; chloride (serum),protein (total):<0.9 * LLN or >1.1 8 ULN (if pre-Rx < LLN, then <0.9 * pre-Rx or > ULN. If pre-Rx > ULN, then >1.1 * pre-Rx or < LLN); calcium (total): <0.8 * LLN or >1.2 * ULN (if pre-Rx < LLN, then <0.9 * pre-Rx or > ULN. If pre-Rx > ULN, then >0.75 * pre-Rx or < ULN).|Continuously from start of ST period up to 56 days post the last dose in the short-term period or start of the long-term period, whichever occurred first.|All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period.||participants|||Number
749934|NCT00547521|Secondary|Number of Participants With MAs in Serum Chemistry During the ST Study: Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Bilirubin (Total), G-Glutamyl Transferase (G-GT) and Blood Urea Nitrogen (BUN)|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria. ALP: >2.0 * ULN (if pre-Rx > ULN, then >3 * pre-Rx); AST, ALT: > 3 * ULN (if pre-Rx > ULN, then > 4 * pre-Rx); bilirubin (total): >2 * ULN, or if pre Rx > ULN then >4 * Pre Rx; BUN : >2 * pre Rx; GGT : >2 * ULN, or if pre Rx > ULN then >3 * pre Rx.|Continuously from start of ST period up to 56 days post the last dose in the short-term period or start of the long-term period, whichever occurred first.|All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period.||participants|||Number
757496|NCT00608491|Secondary|Change in Blood Potassium Level||Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mEq/L||Standard Deviation|Mean
749935|NCT00547521|Secondary|Number of Participants With MAs in Hematology During the ST Study: Neutrophils + Bands (Absolute), Lymphocytes (Absolute), Monocytes (Absolute), Basophils (Absolute) and Eosinophils (Absolute)|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following hematology MA definitions specify the criteria for the data presented. Neutrophils + bands (absolute): <1.00 * 10^3cells/microlitre (uL); lymphocytes (absolute): <0.75 * 10^3 cells/uL or >7.50 * 10^3 cells/uL; monocytes (absolute): >2.00 * 10^3 cells/uL; basophils (absolute): >0.40 * 10^3 cells/uL; eosinophils (absolute): >0.75 * 10^3 cells/uL.|Continuously from start of ST period up to 56 days post the last dose in the short-term period or start of the long-term period, whichever occurred first.|All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept)in the ST period.||participants|||Number
749936|NCT00547521|Secondary|Number of Participants With Marked Abnormalities (MAs) in Hematology During the ST Study: Hemoglobin, Hematocrit, Platelet Count, Erythrocytes and Leukocytes|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following hematology MA definitions specify the criteria for the data presented. Hemoglobin: >3 g/dL decrease from pre-treatment (pre Rx); hematocrit: <0.75 * pre-Rx value; platelet count: <0.67 * (LLN -lower limit of normal) (or, if pre-Rx value <LLN, then <0.5 * pre-Rx value and <100,000/mm^3); leukocytes: <0.75 * LLN or >1.25 * ULN (or, if pre-Rx value <LLN, then <0.8 * pre-Rx or >(ULN -upper limit of normal) ; erythrocytes: <0.75 * pre Rx.|Continuously from start of ST period up to 56 days post the last dose in the short-term period or start of the long-term period, whichever occurred first.|All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period.||participants|||Number
749937|NCT00547521|Secondary|Number of Participants With AEs of Special Interest During the ST Study|An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition (even if not caused by the study drug). For this study, AEs of particular importance were associated with the use of immunomodulatory agents: infections, autoimmune disorders, malignancies, and injection reaction AEs (systemic AEs occurring within 24 hours of SC injection and local injection site reactions) were recorded.|Continuously through ST period (up to Day 113). Includes the data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first.|All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period, were included in the safety analyses.||participants|||Number
749938|NCT00547521|Secondary|Number of Participants Who Experienced Drug-related SAEs and Drug-related AEs During the ST Study|Drug-related AEs are those events with a relationship to the study therapy of certain; probable; possible; or missing. Drug-related SAEs are those events with any relationship to the study therapy.|Continuously through ST period (upto Day 113). Includes the data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first.|All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period, were included in the safety analyses.||participants|||Number
749939|NCT00547521|Secondary|Number of Participants Who Died, Experienced SAEs, Experienced AEs or Who Discontinued Due to AEs During the ST Study|AEs: any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to any AEs or SAEs were recorded.|Continuously through ST period (upto Day 113). Includes the data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first.|All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period, were included in the safety analyses.||participants|||Number
749940|NCT00547521|Secondary|Cross Tabulations of Number of Participants With Positive and Negative Status for RF at Day 113 With Baseline, in the ST Study|RF is an autoantibody that is usually present in the serum of people with rheumatoid arthritis. The cut-point value for seroconversion was 15 IU/mL (>= 15 IU/mL resulted in a positive result). Cross-tabulation of frequency of seroconversion of RF at Day 113 with baseline, in the ST period, was provided.|Baseline and Day 113.|All treated participants included those participants who received at least 1 dose of the study medication (abatacept) in the ST period.||participants|||Number
749941|NCT00547521|Secondary|Change From Baseline in All HAQ-DI Components at End of the 4-month Treatment Period (Day 113) of the ST Study|HAQ-DI takes into account participant’s use of aids or devices or assistance in scoring algorithm for a disability category. The questionnaire includes 20 questions assessing physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The questions are evaluated on a 4-point scale: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty and 3 = unable to do. Higher scores indicate greater dysfunction. The score is calculated by summing worst scores in each domain and dividing by the number of domains answered.|Baseline and Month 4 (Day113).|All treated participants included those participants who received at least 1 dose of the study medication (abatacept) in the ST period. n is the number of participants with baseline and post-baseline values.||Units on a scale||95% Confidence Interval|Mean
749942|NCT00547521|Secondary|Change From Baseline in Physical Functioning (HAQ-DI) at End of the 4-month Treatment Period (Day 113) of the ST Study|HAQ-DI takes into account participant’s use of aids or devices or assistance in scoring algorithm for a disability category. The questionnaire includes 20 questions assessing physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The questions are evaluated on a 4-point scale: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty and 3 = unable to do. Higher scores indicate greater dysfunction. The score is calculated by summing worst scores in each domain and dividing by the number of domains answered.|Baseline and Month 4 (Day 113).|All treated participants included those participants who received at least 1 dose of the study medication (abatacept) in the ST period with baseline and post-baseline values.||Units on a scale||95% Confidence Interval|Mean
749954|NCT00547534|Primary|Number of Participants With Progression Free Survival at 2 Years|To determine the progression-free survival following treatment with the BVR combination in patients with relapsed or refractory indolent and mantle cell non-Hodgkin lymphoma.|Two years|Analysis was per protocol.||Participants|||Number
749944|NCT00547521|Primary|Cross Tabulations of the Number of Participants With Positive and Negative Immunogenicity Status at Baseline and Each Visit During the ST Study (for MSD Results)|The ECL (MSD) assay method is a validated, sensitive assay technique used to analyze presence of abatacept-specific antibodies in serum . It is more sensitive and has a higher drug tolerance than the ELISA method. For anti-abatacept antibody ECL(MSD) assay, a sample was considered seropositive if it had a titer of 10 or greater and if immunodepletion was observed with abatacept, or abatacept and CTLA4-T. Those responses that were not positive in the initial screen or were not confirmed to be positive based on immunodepletion were reported as seronegative and were assigned a value of < 10.|Baseline and day 15, 29, 43, 57, 85 and 113.|Treated participants in the ST period who were evaluable for anti-abatacept or anti-CTLA4-T responses. The overall percentage of subjects who had at least one positive sample was very low, therefore this analysis was not necessary.|||||
749945|NCT00547521|Primary|Cross Tabulations of the Number of Participants With Positive and Negative Immunogenicity Status at Baseline and Each Visit During the ST Study (for ELISA Results)|ELISA is a validated, sensitive assay technique used to analyze presence of abatacept-specific antibodies in serum. For anti-abatacept antibody ELISA, a sample was considered seropositive if it had a titer of 400 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of < 400. A sample was considered positive in CTLA4-T antibody ELISA if it had a titer of 25 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of < 25.|Baseline and on day 15, 29, 43, 57, 85 and 113|Treated participants in the ST period who were evaluable for anti-abatacept or anti-CTLA4-T responses.The overall percentage of subjects who had at least one positive sample was very low, therefore this analysis was not necessary.|||||
749946|NCT00547521|Primary|Immunogenicity in MTX Naive and MTX-previous Users in Cohort 1 at Day 113 of the ST Study (for MSD Results)|The ECL (MSD) assay method is a validated, sensitive assay technique used to analyze presence of abatacept-specific antibodies in serum. It is more sensitive and has a higher drug tolerance than the ELISA method. For anti-abatacept antibody ECL (MSD) assay, a sample was considered seropositive if it had a titer of 10 or greater and if immunodepletion was observed with abatacept, or abatacept and CTLA4-T. Those responses that were not positive in the initial screen or were not confirmed to be positive based on immunodepletion were reported as seronegative and were assigned a value of < 10.|Day 113.|Treated participants in the ST period who were evaluable for anti-abatacept or anti-CTLA4-T responses. There were no positive IMG samples on Day 113, therefore this analysis was not necessary.|||||
749947|NCT00547521|Primary|Immunogenicity in MTX Naive and MTX-previous Users in Cohort 1 at Day 113 of the ST Study (for ELISA Results)|ELISA is a validated, sensitive assay technique used to analyze presence of abatacept-specific antibodies in serum. For anti-abatacept antibody ELISA, a sample was considered seropositive if it had a titer of 400 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of < 400. A sample was considered positive in CTLA4-T antibody ELISA if it had a titer of 25 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of < 25.|Day 113.|Treated participants in the ST period who were evaluable for anti-abatacept or anti-CTLA4-T responses. There were no positive Immunoglobulin G (IMG) samples on Day 113, therefore this analysis was not necessary.|||||
749948|NCT00547521|Primary|Number of Participants With Positive Anti-abatacept Responses to Abatacept (Meso-Scale Discovery [MSD] Electrochemiluminescence [ECL] Assay Method) Over Time During the ST Study|The ECL (MSD) assay method is a validated, sensitive assay technique used to analyze presence of abatacept-specific antibodies in serum. It is more sensitive and has a higher drug tolerance than ELISA method. For the anti-abatacept antibody ECL (MSD) assay, a sample was considered seropositive if it had a titer of 10 or greater and if immunodepletion was observed with abatacept, or abatacept and CTLA4-T. Those responses that were not positive in the initial screen or were not confirmed to be positive based on immunodepletion were reported as seronegative and were assigned a value of < 10.|Day 15, 29, 43, 57, 85,113 and 28, 56 and 85 days post last dose.|Treated participants in the ST period who were evaluable for anti-abatacept or anti-CTLA4-T responses. n=number of participants who were evaluated for this measure at each timepoint, for each group respectively.||participants|||Number
749949|NCT00547521|Primary|Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses (ELISA Method) Over Time During the ST Study|ELISA is a validated, sensitive assay technique used to analyze presence of abatacept-specific antibodies in serum. For anti-abatacept antibody ELISA, a sample was considered seropositive if it had a titer of 400 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of < 400. A sample was considered positive in CTLA4-T antibody ELISA if it had a titer of 25 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of < 25.|Day 15, 29, 43, 57, 85,113 and 28, 56, and 85 days post last dose.|Treated participants in the ST period who were evaluable for anti-abatacept or anti-CTLA4-T responses. n = those participants who were evaluated for this measure at each timepoint, for each group respectively.||participants|||Number
749950|NCT00547521|Secondary|Change From Baseline in DAS28-CRP Score at End of 4-month (Day 113) of the ST Study|DAS28-CRP is a continuous variable which is a composite of 4 variables: the number of tender joint out of 28, the number of swollen joint out of 28, C-reactive protein (CRP) in milligrams/Liter (mg/L) and subject assessment of disease activity measure on a VAS of 100mm. DAS 28 = 0.56 * sqrt(tender28) + 0.28 * sqrt(swollen28) + 0.36 * ln(CRP+1) + 0.014 * VAS + 0.96.|Baseline and Month 4 (Day113).|All treated participants included those participants who received at least 1 dose of the study medication (abatacept) in the ST period with baseline and post-baseline values.||Units on a scale||95% Confidence Interval|Mean
749951|NCT00547521|Primary|Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses (Enzyme-linked Immunosorbent Assay [ELISA] Method) at Day 113 of the ST Study|ELISA is a validated, sensitive assay technique used to analyze presence of abatacept-specific antibodies in serum. For anti-abatacept antibody ELISA, a sample was considered seropositive if it had a titer of 400 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of < 400. A sample was considered positive in CTLA4-T antibody ELISA if it had a titer of 25 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of < 25.|Day 113|Treated participants in the ST period who were evaluable for anti-abatacept or anti-CTLA4-T responses.||participants|||Number
749955|NCT00547638|Other Pre-specified|Incidence of Any Other Anticipated or Unanticipated Adverse Events|Adverse events were coded using the MedDRA dictionary. In addition severity, relationship to treatment and procedure, action taken and outcome were described. Adverse events were summarized by treatment group. No formal statistical analysis was performed on overall incidence of adverse events with the exception of clinical infection, acute inflammatory reactions and skin blistering.|Day 30|Intent to treat population in which subjects experiencing at least 1 adverse event were reported and analyzed.||Participants Experiencing at least 1 AE|||Number
749956|NCT00547638|Other Pre-specified|Incidence of Skin Blistering at Day 14|The incidence of skin blistering is presented as a tabulation of the presence or absence of skin blistering by treatment group. A formal statistical analysis of the incidence of blistering at Day 14 was performed using the Fisher's Exact Test.|Day 14|Intent to treatment population was analyzed for the incidence of skin blistering at Day 14.||Participants With Blistering at Day 14|||Number
749957|NCT00547638|Other Pre-specified|The Incidence and Extent of Local Acute Inflammatory Reactions Including Edema, Erythema, Pain and Local Temperature at Day 14 and Day 30|Each parameter (edema, erythema, pain and location temperature) is measured on a 4 point scale (0, 1, 2, 3). The individual values are added to generate an overall AIRE Score. AIRE Scores were summarized as good (score=0) versus poor (score>0) by treatment group and compared for differences using the Fisher's Exact Test.|At Day 14 and Day 30|Intent to treat population was analyzed for subjects in each group with Total AIRE Score of 1-12 at Day 14 and Day 30. Analysis is performed on the proportion of subjects in each group with Total AIRE Scores greater than 0 versus those less or equal to 0 at each timepoint.||Participants With AIRE Score >0|||Number
749958|NCT00547638|Other Pre-specified|The Comparison of Test and Control Arms Regarding Incidence of Clinical Infection at Day 14 and Day 30|Incidence of clinical infection (defined by observation of redness, swelling, purulent discharge, pain, increased skin temperature, fever or other systemic signs of injection) collected at the Day 14 and Day 30 visits. A formal statistical analysing using Fisher's Exact Test was performed.|Through Day 30|Intent to treat population was analyzed for the presence of signs of infection at Day 14 and Day 30.||Participants|||Number
749959|NCT00547638|Secondary|Cosmesis|The evaluation of healing and cosmetic outcome post-treatment using the modified Hollander Cosmesis Scale (mHCS). The proportion of patients with a zero (0) score will be compared between the test and control arms.|30 days (±5 days)|Intent to Treat Population where good outcome for overall appearance. A p-value of 0.457 was determined following comparison by Fisher's Exact Test.||Participants|||Number
749960|NCT00547638|Primary|The Incidence of Wound Closure Post-treatment, as Defined by Continuous Approximation of Wound Margins From the Time of Wound Closure Until the Day of Evaluation Without Dehiscence or Need for Reclosure.|Data is presented as binomial tables of proportions of successes and failures for each treatment. The 90% two-sided exact confidence intervals (CI) for the differences in the proportions for each study group was calculated. The upper limit of the 90% CI was then taken to represent the upper limit of the one-sided 95% CI. The primary objective of the study was met if the upper limit of the one-sided 95% CI of the difference in proportions (comparator minus treatment) did not exceed 8%.|14 days (±2 days)|Intent to treat population results are presented.With respect to Measure Description it is defined as the number of participants in each group with successful wound-closure (approximation).||Participants|||Number
749961|NCT00547703|Secondary|Side Effects|To assess frequency of side effects in patients receiving Nortriptyline for nonulcer dyspepsia. Patients were asked about side effects on each office visit and ask to call for significant side effects.|8 weeks||||||
749962|NCT00547703|Secondary|QOLRAD Questionaire for Patients With Upper Abdominal Symptoms|Patients were administered the validated QOLRAD questionnaire on quality of life to assess if nortriptyline improves quality of life in patients with nonulcer dyspepsia|8 weeks||||||
749963|NCT00547703|Primary|Question on Whether Patient Has Had Adequate Relief of Abdominal Pain or Discomfort Reported by a Simple Yes or no Answer.|Patient would answer yes or no to a simple question asking whether they had adequate relief of abdominal pain or discomfort. This was measured at weeks 2,4 and 8 of the study but only week 8 was reported. What is being reported is the number of participants who answered yes.|8 weeks|All patients who completed the 8 weeks of the study||participants|||Number
749964|NCT00547911|Secondary|Heart Rate After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone|Heart rate was assessed at baseline and after drug administration at 1 hour, 2 hours, 3 hours, 6 hours, and 24 hours.|Up to 24 hours after receiving drug(s)|Data for Healthy Volunteers and all Patient groups was combined for analysis due to the low N-value because of premature study termination, which is further described in the “Limitations and Caveats” section. In addition, some subject data was unable to be analyzed due to unreliable measurements.||BPM||Standard Error|Mean
749965|NCT00547911|Secondary|Diastolic Blood Pressures After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone|Diastolic blood pressure was assessed at baseline and after drug administration at 1 hour, 2 hours, 3 hours, 6 hours, and 24 hours.|Up to 24 hours after receiving drug(s)|Data for Healthy Volunteers and all Patient groups was combined for analysis due to the low N-value because of premature study termination, which is further described in the “Limitations and Caveats” section. In addition, some subject data was unable to be analyzed due to unreliable measurements.||mmHg||Standard Error|Mean
749966|NCT00547911|Secondary|Systolic Blood Pressures After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone|Systolic blood pressure was assessed at baseline and after drug administration at 1 hour, 2 hours, 3 hours, 6 hours, and 24 hours.|Up to 24 hours after receiving drug(s)|Data for Healthy Volunteers and all Patient groups was combined for analysis due to the low N-value because of premature study termination, which is further described in the “Limitations and Caveats” section. In addition, some subject data was unable to be analyzed due to unreliable measurements.||mmHg||Standard Error|Mean
749967|NCT00547911|Primary|Plasma DHPG Concentrations After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone|Blood samples were obtained at baseline and after drug administration at 1 hour, 2 hours, 3 hours, 6 hours, 24 hours, and 48 hours to assess plasma dihydroxyphenylglycol (DHPG) concentrations.|Up to 48 hours after receiving drug(s)|Data for Healthy Volunteers and all Patient groups was combined for analysis due to the low N-value because of premature study termination, which is further described in the “Limitations and Caveats” section. In addition, some subject data was unable to be analyzed due to unreliable measurements.||nmol/L||Standard Error|Mean
749968|NCT00547911|Primary|Plasma DHMA Concentrations After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone|Blood samples were obtained at baseline and after drug administration at 1 hour, 2 hours, 3 hours, 6 hours, 24 hours, and 48 hours to assess plasma droxymandelic acid (DHMA) concentrations.|Up to 48 hours after receiving drug(s)|Data for Healthy Volunteers and all Patient groups was combined for analysis due to the low N-value because of premature study termination, which is further described in the “Limitations and Caveats” section. In addition, some subject data was unable to be analyzed due to unreliable measurements.||nmol/L||Standard Error|Mean
749969|NCT00547911|Primary|Plasma Norepinephrine Concentrations After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone|Blood samples were obtained at baseline and after drug administration at 1 hour, 2 hours, 3 hours, 6 hours, 24 hours, and 48 hours to assess plasma norepinephrine concentrations.|Up to 48 hours after receiving drug(s)|Data for Healthy Volunteers and all Patient groups was combined for analysis due to the low N-value because of premature study termination, which is further described in the “Limitations and Caveats” section. In addition, some subject data was unable to be analyzed due to unreliable measurements.||nmol/L||Standard Error|Mean
749970|NCT00547911|Primary|Plasma LDOPS Concentrations After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone|Blood samples were obtained at baseline and after drug administration at 1 hour, 2 hours, 3 hours, 6 hours, 24 hours, and 48 hours to assess plasma droxidopa (LDOPS) concentrations.|Up to 48 hours after receiving drug(s)|Data for Healthy Volunteers and all Patient groups was combined for analysis due to the low N-value because of premature study termination, which is further described in the “Limitations and Caveats” section. In addition, some subject data was unable to be analyzed due to unreliable measurements.||nmol/L||Standard Error|Mean
749971|NCT00548041|Primary|Feasibility of Rapid HIV Testing in Emergency Department|Feasibility was assessed as number of participants who were approached and agreed to participate in rapid HIV testing and then had testing completed.|2 years|||participants|||Number
749972|NCT00548132|Secondary|Clinical Sepsis Episodes/Per 1000 Catheter Days|This measure is a combination of patients with positive blood cultures (BSI) and patients who had signs and symptoms of sepsis but with negative blood cultures. These patients still required treatment with antibiotics.|2 years|||sepsis episodes/1000 catheter days|||Number
749973|NCT00548132|Primary|The Number of Catheter Related Bloodstream Infections (BSI) /1000 Catheter Days in Both Arms|The outcome measure is the number of episodes of bloodstream infections (BSI) divided by the catheter days at risk multiplied by 1000 for standardization|2 years|Based on previous data (unpublished),there would be a 60% reduction in the incidence of bloodstream infections-- the primary outcome. The number of patients included in this study had a large enough sample size to show a statistical difference.||BSIs /1000 catheter days|||Number
749974|NCT00548145|Secondary|MMSE, Neuropsychiatric Inventory, GDS-15, Zarit Burden Scale, Physical Self-Maintenance Scale, IADL, Everyday Memory Checklist, TC, HDL-C, Non HDL-C*, Apo A1, Apo B, Apo E *: Non HDL-C = (TC) - (HDL-C)|Mini-Mental State Examination(MMSE),Geriatric Depression Scale-15(GDS-15),Instrumental Activities of Daily Living Scale(IADL),Total Cholesterol(TC)|baseline and 12 months||||||
749975|NCT00548145|Primary|Alzheimer's Disease Assessment Scale-cognitive Component-Japanese Version(ADAS-Jcog)|Alzheimer's Disease Assessment Scale-cognitive component-Japanese version is a cognitive test for Alzheimer's disease. This test includes some aspects that assess memory ,orientation, language, praxis, and so on. The possible range of this test is 0-70 points.Higher total points indicate more impairment.|baseline and 12 months|||scores on a scale||Standard Deviation|Mean
749976|NCT00548184|Secondary|Data Analysis of the Biomarkers: Immunohistochemical Staining of Cells From Breast Biopsies and Skin Biopsies Will be Performed.||one year||||||
749977|NCT00548184|Primary|Pathologic Assessment After Study Treatment|Pathologic Assessment After 12 weeks of lapatinib and trastuzumab with or without endocrine therapy. Pathologic complete response: no invasive cancer in the residual breast. Near pathologic complete response: residual disease of less than 1 cm in breast.|12 weeks|65 patients were enrolled and received the study treatment. 1 patient was found ineligible for this study therefore she was excluded from outcome report.||participants|||Number
749978|NCT00548249|Secondary|Number of Subjects With a Rise in Hemoglobin (Hgb) to 12.6 g/dL or More on Two Separate Occasions Measured One Week Apart.||two separate sessions measured one week apart.|Modified intent-to-treat population, consisting of all subjects who received any amount of randomized study medication||Subjects|||Number
749979|NCT00548249|Secondary|Estimate the Amount of SFP Transferred From the Dialysate to the Blood During a Dialysis Session.||At each dialysis session for up to 26 weeks||||||
749980|NCT00548249|Secondary|Number of Subjects With Infection Episodes Requiring Antibiotic or Anti-fungal Therapy in Each Treatment Group.||At each dialysis session for up to 26 weeks|||Subjects|||Number
749981|NCT00548249|Secondary|Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment.|Efficacy of SFP administration in dialysate solution as measured by Chr values every four weeks, and at the end of the Subject's Treatment (up to 26 weeks).|Every 4 weeks|Modified intent-to-treat population, consisting of all subjects who received any amount of randomized study medication||pg||Standard Deviation|Mean
749982|NCT00548249|Secondary|Time in Days for Hgb to Decrease by a Total of > = 1.0 g/dL From Baseline on Each of Two Successive Measurements in Each Treatment Group.|Kaplan-Meier Estimate of Time to First Hgb Decrease by >= 1.0 g/dL|Up to 26 weeks|"Modified intent-to-treat population, consisting of all subjects who received any amount of randomized study medication.
Because of the small number of patients reaching the endpoint of decrease in Hgb >= 1.0 g/dL, the Kaplan-Meier analysis could not estimate the number of days for at least one treatment group for the 50th percentile and higher."||Days|||Number
749983|NCT00548249|Secondary|Change From Baseline in Hemoglobin (Hgb)||two time points: baseline and final evaluation (last post baseline assessment, up to 26 weeks)|Modified intent-to-treat population, consisting of all subjects who received any amount of randomized study medication||grams/ deciliter (g/dL)||Standard Deviation|Mean
750010|NCT00548327|Primary|Changes in Cognitive Function Measured by Neuropsychological Testing|Neuropsychological testing consists of a battery of 10-12 individual tests to measure cognitive function. We expect both a drug effect and a genotype effect on neuropsychological tasks that measure dorsolateral prefrontal cortex (DLPFC) executive function, mostly in individuals who share the val/val genotype with respect to the met/met genotype.|2 hours after the first or the second dose of Atomoxetine or placebo on 14th day|Data were not collected for analysis because the study was terminated before target accrual|||||
749984|NCT00548249|Primary|Percent of Subjects Whose Hemoglobin (Hgb) Decreases by a Total of 1.0 Grams/ Deciliter (g/dL) (or More) From Baseline on Each of Two Successive Measurements.|Efficacy of a Soluble Ferric Pyrophosphate (SFP)-containing dialysate solution in maintaining physiological iron levels during chronic HD, as measured by the percent of subjects whose hgb decreases by a total of 1.0 g/dL (or more) from baseline on each of two successive measurements. Hemoglobin was obtained weekly at the mid-week dialysis treatments and compared to baseline value (average of two hgb measurements obtained at the two consecutive baseline visits prior to randomization).|up to 26 weeks|Modified intent-to-treat population, consisting of all subjects who received any amount of randomized study medication||Percent of subjects|||Number
749985|NCT00548262|Secondary|Change From Baseline in Chemistry Laboratory Test Data (Measured as IU/L)|Chemistry laboratory test data measured as international units per (IU/L).|Baseline to Week 2 Follow-up|Safety analysis population; N=number of participants with analyzable laboratory data; (n)=number of subjects with data for each test at observation.||IU/L||Full Range|Median
749986|NCT00548262|Secondary|Change From Baseline in Chemistry Laboratory Test Data (Measured as mg/dL)|Chemistry laboratory test data measured as milligrams per deciliter (mg/dL).|Baseline to Week 2 Follow-up|Safety analysis population; N=number of participants with analyzable laboratory data; (n)=number of subjects with data for each test at observation.||mg/dL||Full Range|Median
749987|NCT00548262|Secondary|Change From Baseline in Vital Signs: Respiration Rate|Respiration rate measured as respirations per minute (resp/min).|Baseline to Week 2 Follow-up|Safety analysis population||resp/min||Full Range|Median
749988|NCT00548262|Secondary|Change From Baseline in Vital Signs: Temperature|Temperature measured as degrees of Celsius (C).|Baseline to Week 2 Follow-up|Safety analysis population||Degrees of Celsius||Full Range|Median
749989|NCT00548262|Secondary|Change From Baseline in Vital Signs: Weight|Weight measured as kilograms (kg).|Baseline to Week 2 Follow-up|Safety analysis population; N=number of participants with evaluable data.||kg||Full Range|Median
749990|NCT00548262|Secondary|Change From Baseline in Vital Signs: Supine Heart Rate|Supine heart rate measured as beats per minute (bpm).|Baseline to Week 2 Follow-up|Safety analysis population||bpm||Full Range|Median
749991|NCT00548262|Secondary|Change From Baseline in Vital Signs: Supine Blood Pressure|Supine systolic and diastolic blood pressure BP) measured as millimeters of mercury (mmHg).|Baseline to Week 2 Follow-up|Safety analysis population||mmHg||Full Range|Median
749992|NCT00548262|Secondary|Length of Stay in Intensive Care Unit (ICU)|Defined as the number of days from date of first drug administration to date of first ICU discharge. Week 6 Follow-up visit conducted by phone.|Baseline up to Week 6 Follow-up|MITT; N=number of participants evaluable for length of time in ICU.||Days||95% Confidence Interval|Median
749993|NCT00548262|Secondary|Length of Hospital Stay|Defined as the number of days from date of first drug administration to date of first hospital discharge if participant was discharged to home or other location. Week 6 Follow-up visit conducted by phone.|Baseline to Week 6 Follow-up|MITT; data not summarized using descriptive statistics.||days|||Number
749994|NCT00548262|Secondary|Duration of Exposure to Intravenous Anidulafungin Prior to Switch to Oral Voriconazole Treatment|Defined as time in days from first intravenous administration of Anidulafungin to the date of earliest recorded documentation of switch to oral Voriconazole treatment. Participants received at least 5 days (and a maximum of 42 days) of IV Anidulafungin; after this, they may continue treatment with oral Voriconazole for at least 14 days from the day of last positive culture up to a maximum of 42 days.|Baseline to Day 42|Safety analysis set: all participants who received any dose of study medication.||days||Full Range|Median
749995|NCT00548262|Secondary|Time to Negative Blood, Specimen, or Tissue Culture|Defined as time from first drug administratin to date of earliest recorded documentation of negative blood, specimen, or tissue culture (absence of Candidemia or Invasive Candidiasis). Candidemia (positive blood culture) or Invasive Cadidiasis (yeast cells in histopathological or cytopathological exam).|Baseline to Week 2 Follow-up|MITT; data not summarized using descriptive statistics.||Days|||Number
749996|NCT00548262|Secondary|Number of Participants With Death Attributable (Yes or No) to Candidemia or Invasive Candidiasis|"Death is attributable to Candidemia or Invasive Candidiasis if investigator recorded disease under study as cause of death. Candidemia (positive blood culture) or Invasive Cadidiasis (yeast cells in histopathological or cytopathological exam). Week 6 Follow-up visit conducted by phone."|Baseline to Week 6 Follow-up|MITT. MITT. Death for 1 participant reported twice in this study(recorded at End of Treatment and at End of Study); both instances are reported in this table under Attributal Death=No.||participants|||Number
749997|NCT00548262|Secondary|Number of Participants Per Survival Status (Alive or Dead) on Day 30||Day 30|MITT||participants|||Number
749998|NCT00548262|Secondary|Number of Participants for Global Response by Acute Physiological Assessment and Chronic Health Evaluation II (APACHE II) Score|Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Categorized as global Success if both clinical and microbiological response=success; Failure defined as all other combinations. Global response assessed as APACHE II score <20 (less affected) or ≥20 (more severe). APACHE II assesses severity of illness in acutely ill participants; measurements computed for physiologic variables were transformed to integer score ranging 0 (normal) to 71 (more severe). Higher scores indicate more severe disease and higher risk of death.|EIVT (up to Day 42), EOT (up to Day 42), Week 2 Follow-up|MITT. Missing or indeterminate set to Failure; CI not calculated for Failure.||participants|||Number
749999|NCT00548262|Secondary|Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up|Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Global response at Week 2 F/U was assessed for participants categorized with baseline risk factors for Candidemia and Invasive Candidiasis: ICU stay ≥ 4 days, mechanical ventilation, broad spectrum antibiotics (antibiotics), central venous (CV) catheter, total parental nutrition (TPN), dialysis, abdominal surgery, solid organ transplant, renal insufficiency, chemotherapy, pancreatitis, systemic steroids or immunosuppressives (Systemic steroids/immunos), neutropenic status, or elderly.|Baseline, Week 2 Follow-up (F/U)|MITT. Global Success if both clinical and microbiological response=success; Failure=all other combinations. Missing or indeterminate set to Failure; CI not calculated for failure. Due to small sample size, data insufficient for analysis by status=elderly >65 years of age; not summarized.||participants|||Number
763686|NCT00670540|Secondary|Percentage of Participants With Treatment Anticoagulant Prescribed||after inclusion|||percentage of participants||95% Confidence Interval|Number
750000|NCT00548262|Secondary|Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT|Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Global response at EIVT was assessed for participants categorized with baseline risk factors for Candidemia and Invasive Candidiasis: ICU stay ≥ 4 days, mechanical ventilation, broad spectrum antibiotics (antibiotics), central venous (CV) catheter, total parental nutrition (TPN), dialysis, abdominal surgery, solid organ transplant, renal insufficiency, chemotherapy, pancreatitis, systemic steroids or immunosuppressives (Systemic steroids/immunos), neutropenic status, or elderly.|EIVT (up to Day 42)|MITT. Global Success if both clinical and microbiological response=success; Failure=all other combinations. Missing or indeterminate set to Failure; CI not calculated for failure. Due to small sample size, data was insufficient for analysis by status=elderly >65 years of age; not summarized.||participants|||Number
750001|NCT00548262|Secondary|Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT|Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Global response at EOT was assessed for participants categorized with baseline risk factors (Yes or No status) for Intensive Care Unit (ICU) stay ≥ 4 days, mechanical ventilation, broad spectrum antibiotics (antibiotics), central venous (CV) catheter, total parental nutrition (TPN), dialysis, abdominal surgery, solid organ transplant, renal insufficiency, chemotherapy, pancreatitis, systemic steroids or immunosuppressives (Systemic steroids/immunos), neutropenic status, or elderly.|Baseline, EOT (up to Day 42)|MITT. Global Success if both clinical and microbiological response=success; Failure=all other combinations. Missing or indeterminate set to Failure; CI not calculated for failure. Due to small sample size, data was insufficient for analysis by status=elderly (>65 years of age); not summarized.||participants|||Number
750002|NCT00548262|Secondary|Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: Week 2 Follow-up|Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Categorized as global Success if both clinical and microbiological response=success; Failure defined as all other combinations. Global response at Week 2 Follow-up was assessed per the type of Candida species that was isolated at the baseline visit.|Baseline, Week 2 Follow-up|MITT. Missing or indeterminate set to Failure; CI was not calculated for status of Failure.||participants|||Number
750003|NCT00548262|Secondary|Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EOT|Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Categorized as global Success if both clinical and microbiological response=success; Failure defined as all other combinations. Global response at EOT was assessed per the type of Candida species that was isolated at the baseline visit.|Baseline, EOT (up to Day 42)|MITT. Missing or indeterminate set to Failure; CI not calculated for Failure.||participants|||Number
750004|NCT00548262|Secondary|Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EIVT|Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Categorized as global Success if both clinical and microbiological response=success; Failure defined as all other combinations. Global response at EIVT was assessed per the type of Candida species that was isolated at the baseline visit.|Baseline, EIVT (up to Day 42)|MITT. Missing or indeterminate set to Failure; CI not calculated for Failure.||participants|||Number
750005|NCT00548262|Secondary|Number of Participants for Global Response (Based on Clinical and Microbiological Success or Failure)|Clinical Success (cure=resolution of Candida signs and symptoms [s/s] or improvement=significant but incomplete resolution of s/s) or Failure (at least 3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological Success (eradication=negative culture for baseline Candida species (spp) or presumed eradication=follow-up (f/u) culture not available (n/a) and clinical outcome defined as success) or Failure (persistence=positive culture for at least 1 baseline Candida spp or presumed persistence=f/u culture n/a and clinical outcome defined as failure).|End of Intravenous Treatment (EIVT) (up to Day 42), Week 2 Follow-up|MITT. Success=clinical and microbiological success; Failure=all other combinations. Missing or indeterminate set to Failure; CI not calculated for Failure.||participants|||Number
750006|NCT00548262|Primary|Number of Participants for Global Response (Based on Clinical and Microbiological Success or Failure) at End of Treatment|Clinical Success (cure=resolution of Candida signs and symptoms [s/s] or improvement=significant but incomplete resolution of s/s) or Failure (at least 3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological Success (eradication=negative culture for baseline Candida species (spp) or presumed eradication=follow-up (f/u) culture not available (n/a) and clinical outcome defined as success) or Failure (persistence=positive culture for at least 1 baseline Candida spp or presumed persistence=f/u culture n/a and clinical outcome defined as failure).|End of Treatment (EOT) (up to Day 42)|Modified Intent-to-Treat population (MITT): all Intent-to-Treat (ITT) participants (took at least 1 dose of study treatment) and with a positive baseline culture for a Candida spp within 96 hours before entry into the study. Success=clinical and microbiological success; Failure=all other combinations. Missing or indeterminate set to Failure.||participants|||Number
750007|NCT00548327|Other Pre-specified|Blood Plasma Concentration of Atomoxetine|Blood for drug plasma levels is obtained before and 3 hours after dosing on the 14th day receiving Atomoxetine.|before and 3 hours after dosing on the 14th day receiving Atomoxetine|Data were not collected for analysis because the study was terminated before target accrual|||||
750008|NCT00548327|Secondary|Change in The Hamilton Anxiety Rating Scale|The Hamilton Anxiety Rating Scale is a psychological questionnaire to rate the severity of anxiety.It contains 14 symptom-oriented questions.Each of these symptoms is given a severity rating, from not present(scored as 0)to very severe(scored as 4)|At 14th and 35th days|Data were not collected for analysis because the study was terminated before target accrual|||||
750009|NCT00548327|Secondary|Change in The Profile of Mood States|The Profile of Mood States is an instrument that provides a rapid method of assessing transient, fluctuating mood states. The POMS consists of 65 adjectives rated by subjects on a 5-point scale and six factors that derive from this scale are: 1)tension-anxiety, 2)depression-dejection, 3)anger-hostility, 4)fatigue-inertia, 5)vigor-activity and 6)Confusion-bewilderment.|At 14th and 35th days|Data were not collected for analysis because the study was terminated before target accrual|||||
752639|NCT00561600|Secondary|Analysis of Metal Ion Release - Erythrocyte Chromium|Erythrocyte Chromium|Pre-operative|Metal ion sub-study was limited to two sites. All participants with available data are presented below.||ug/L||Full Range|Median
750011|NCT00548327|Secondary|Change in The Positive and Negative Syndrome Scale (PANSS)|The Positive and Negative Syndrome Scale (PANSS) is a 7-point rating scale with (1) indicating the absence of a symptom or behavior and (7) indicating the most severe symptom. The PANSS includes three scales(Positive and Negative Syndromes and General Psychopathology)and five clusters (Anergia, Thought Disturbance, Activation, Paranoid/Belligerence and Depression.|At 14th and 35th days|Data were not collected for analysis because the study was terminated before target accrual|||||
750012|NCT00548327|Primary|Changes in Functional Magnetic Resonance Imaging (fMRI) Blood-oxygen-level-dependent (Bold) Activity|"Main outcome measures were BOLD fMRI response (activation) while performing a prefrontal cortex-dependent task such as N-Back Working Memory with increasing levels of task difficulty. It was expected to have a greater level of activation in BOLD fMRI in schizophrenic patients with respect to normal volunteers, and a greater activation in individuals (either normal volunteers or patients) who share the val/val genotype with respect to the met/met genotype.
Based on prior fMRI studies and on power analysis of neuropsychological variables, at least 28 and 26 subjects are respectively needed to achieve significant power in functional neuroimaging and neuropsychological studies.These sizes provide an 80% power to observe significant differences between drug conditions at the 0.05 level."|2 hours after the first or the second dose of Atomoxetine or placebo on 14th day|Data were not collected for analysis because the study was terminated before target accrual|||||
750013|NCT00548340|Post-Hoc|Average Change From Baseline - Wake After Sleep Onset (WASO) and Total Sleep Time (TST)|Average wake after sleep onset was defined as the time spent awake between onset of sleep (latency to non-awake) and lights-on, as determined by PSG between Baseline, and the average of nights 22 and 29. Total sleep time (TST) was defined as the time spent sleeping between lights-out and lights-on, i.e., full night between Baseline, and the average of nights 22 and 29.|Baseline, Night 22, and Night 29 measurements for WASO and TST|One subject randomized to VEC-162 20 mg did not have post-baseline PSG data and was excluded from the Full Analysis population.||minutes||Standard Error|Mean
750014|NCT00548340|Post-Hoc|Average Change From Baseline - Latency to Persistent Sleep (LPS)|Average latency to persistent sleep is defined as the length of time elapsed between lights off and onset of persistent sleep (defined as the point 10 minutes of uninterrupted sleep has begun as determined by PSG) between Baseline, and the average of nights 22 and 29.|Baseline, Night 22, and Night 29 measurement|One subject randomized to VEC-162 20 mg did not have any post-baseline PSG data and was excluded from the Full Analysis Population.||minutes||Standard Error|Mean
750015|NCT00548340|Secondary|Average Change From Baseline - Wake After Sleep Onset (WASO) and Total Sleep Time (TST)|Average wake after sleep onset was defined as the time spent awake between onset of sleep (latency to non-awake) and lights-on, as determined by PSG between Baseline, and the average of nights 1 and 8. Total sleep time (TST) was defined as the time spent sleeping between lights-out and lights-on, i.e., full night between Baseline, and the average of nights 1 and 8.|Baseline, Night 1, and Night 8 measurements for WASO and TST|One subject randomized to VEC-162 20 mg did not have post-baseline PSG data and was excluded from the Full Analysis population.||minutes||Standard Error|Mean
750016|NCT00548340|Primary|Average Change From Baseline - Latency to Persistent Sleep (LPS)|Average latency to persistent sleep is defined as the length of time elapsed between lights off and onset of persistent sleep (defined as the point at which 10 minutes of uninterrupted sleep has begun as determined by PSG) between Baseline and the average of nights 1 and 8.|Baseline, Night 1, and Night 8 measurement|One subject randomized to VEC-162 20 mg did not have any post-baseline PSG data and was excluded from the Full Analysis Population.||minutes||Standard Error|Mean
750017|NCT00548405|Secondary|Percent Change From Baseline in Magnetic Resonance Imaging Time Constant 2 (MRI-T2) Hyperintense Lesion Volume at Year 2|Percent change in MS lesion volume as measured by MRI-T2 scan was calculated from MRI-T2-weighted scans as the following: (lesion volume at 2 years - lesion volume at Baseline)*100/ (lesion volume at Baseline).|Baseline, Year 2|FAS population. Here, number of participants analyzed was subset of FAS who had assessment for T2 volume at both Baseline and end-of-study (Year 2). Analysis was not performed for Alemtuzumab 24 mg as described in outcome measure 1.||percent change||Standard Deviation|Mean
750018|NCT00548405|Secondary|Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Score at Year 2|MSFC is a multidimensional measure consisting of quantitative tests of ambulation (Timed 25-Foot Walk), manual dexterity (9-Hole Peg Test; 9HPT), and cognitive function (Paced Auditory Serial Addition Test; PASAT). The MSFC score was calculated as the mean of the Z-scores of the 3 components. A Z-score was calculated by subtracting the mean of the reference population from the test result, then dividing by the standard deviation of the reference population. Higher Z-scores reflected better neurological function and a positive change from Baseline indicates improvement. An increase in score indicated an improvement (Z-score range: -3 to +3). Acquisition of disability was measured by change from Baseline in MSFC score at Year 2.|Baseline, Year 2|FAS population. Here, number of participants analyzed signifies subset of FAS who had MSFC score assessment at Baseline; 'n' signifies participants who had MSFC score assessment at Baseline (for Baseline) and at both Baseline and Year 2 (for change at Year 2). Analysis was not performed for Alemtuzumab 24 mg as described in outcome measure 1.||Z-score||Standard Deviation|Mean
750019|NCT00548405|Secondary|Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Year 2|EDSS is an ordinal scale in half-point increments that qualifies disability in participants with multiple sclerosis (MS). It assesses the 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS). Change was calculated by subtracting Baseline value from value at Year 2.|Baseline, Year 2|FAS population. Here, number of participants analyzed was subset of FAS who had EDSS assessment at both Baseline and end-of-study (Year 2). Analysis was not performed for Alemtuzumab 24 mg as described in outcome measure 1.||units on a scale||Standard Deviation|Mean
750020|NCT00548405|Secondary|Percentage of Participants Who Were Relapse Free at Year 2|Participants were considered relapse free at Year 2 if they did not experience a relapse from the date of first study treatment to study completion at 24 months. Percentage of participants who were relapse free at Year 2, estimated using the KM method, was reported.|Year 2|FAS population. Analysis was not performed for Alemtuzumab 24 mg as described in outcome measure 1.||percentage of participants||95% Confidence Interval|Number
752640|NCT00561600|Secondary|Analysis of Metal Ion Release - Erythrocyte Cobalt|Erythrocyte cobalt|pre-operative|Metal ion sub-study was limited to two sites. All participants with available data are presented below.||ug/L||Full Range|Median
750021|NCT00548405|Primary|Annualized Relapse Rate|Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination, attributable to multiple sclerosis that lasted for at least 48 hours, that were present at normal body temperature, and that were preceded by at least 30 days of clinical stability. Annualized relapse rate was estimated through negative binomial regression with robust variance estimation and covariate adjustment for geographic region using observed number of relapses as dependent variable, the log total amount of follow-up from date of first study treatment for each participant as an offset variable, and treatment group and geographic region as model covariates.|Up to 2 years|FAS population. Analysis was not performed for Alemtuzumab 24 mg as described in outcome measure 1.||relapses per participant per year||95% Confidence Interval|Number
750022|NCT00548405|Primary|Percentage of Participants With Sustained Accumulation of Disability (SAD)|EDSS is an ordinal scale in half-point increments that qualifies disability in participants with MS. It assesses 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score: 0 (normal neurological examination) to 10 (death due to MS). As measured by EDSS score, SAD was defined as increase of at least 1.5 points for participants with Baseline score of 0 and increase of at least 1.0 point for participants with a Baseline score of 1.0 or more; and the increase persisted for at least the next 2 scheduled assessments, that is, 6 consecutive months. The onset date of SAD was date of first EDSS assessment that began 6 month consecutive period of SAD. Participants who did not reach SAD endpoint were censored at their last visit. Percentage of participants with SAD, estimated by Kaplan-Meier (KM) method, was reported.|Up to 2 years|FAS population included all randomized participants who received at least 1 dose of study drug as per initial randomization. Analysis was not performed for Alemtuzumab 24 mg as recruitment to this arm was closed early to reduce overall sample size, duration of enrollment period, overall duration of study.||percentage of participants||95% Confidence Interval|Number
750023|NCT00548418|Secondary|Correlate Hypoxia Inducible Factor 1 (HIF-1) and Hypoxia Induced Gene Expression as Measured by Laboratory Studies||When specimens available|None of the correlative studies were performed as the investigator and institution which originally offered to do those assays actually did not participate in accrual to this study. We also did not collect specimens on all patients entered on study.|||||
750024|NCT00548418|Secondary|Correlate Patterns of Gene Expression as Assessed by Microarrays||Correlative studies when specimens available|None of the correlative studies were performed as the investigator and institution which originally offered to do those assays actually did not participate in accrual to this study. We also did not collect specimens on all patients entered on study.|||||
750025|NCT00548418|Secondary|Frequency of Response as Measured by RECIST Criteria (Imaging)|"RECIST criteria:
Complete response is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart.
Partial Response is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD.
Progression is defined as ANY of the following - 20% increase in the sum of LD target lesions, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease, progression of existing non-target lesions
Stable disease is any condition not meeting the above criteria"|Tumor response measured prior to every other cycle of therapy (range of follow-up to measure overall response was 1.6-9.5 months)|26 participants were evaluable for response.||participants|||Number
750026|NCT00548418|Secondary|Overall Survival|Defined as time from study entry until death from any cause or date of last contaqct.|Until death (follow-up ranged from 1.7 months to 33.4 months)|||months||90% Confidence Interval|Median
750027|NCT00548418|Primary|Anti-tumor Activity as Measured by Surviving Progression-free|Defined as the period from study entry until documentation of disease progression, death, or date of last contact, whichever occurred first.|Progression-free survival at 6 months|||percentage of participants|||Number
750028|NCT00548431|Secondary|Incorporation of 6-thioguanine Nucleotides (6TGN) Into Leukocyte DNA, Development of Asparaginase Antibody Production|Biweekly bloodsamples during the 3 months are analyzed for 6TGN incorporation into leucocyte DNA. In addition Methylated Mercaptopurine (MeMP) and Erythrocyte-Methotrexate level is measured|During the 3 months consolidation therapy||02/2018||||
750029|NCT00548431|Primary|Toxicity of Treatment in Terms of Number of Participants With Serious Adverse Events or Adverse Events, Reported|Number of participants following the protocol treatment for the full consolidation therapy with toxicity in this pilot study trying to individually titrate 6-mercaptopurine to the highest tolerable level during Consolidation.|3 months ( 79 days )|||Participants|||Number
750030|NCT00548470|Secondary|Change From Baseline in Psychiatric Symptoms|The Positive and Negative Syndrome Scale (PANSS) was used to measure psychiatric symptoms. Item scores ranged from 1 (Absent) to 6 (Severe) for symptoms on the Positive Scale (total subscale range: 7-42), the Negative Scale (total subscale range: 7-42), and the General Psychopathology Scale (total subscale range:16-96). All three subscales were summed for the PANSS total score (total scale range: 30-180). Higher numbers indicate more psychopathology. Therefore, if scores are reduced at post-baseline ratings, this would indicate lower psychopathology.|Baseline and 2 months later|||Units on the PANSS scale||Standard Deviation|Mean
750031|NCT00548470|Secondary|RBANS Neuropsychological Battery|The scale is Repeatable Battery for the Assessment to Neuropsychological Status (RBANS). This scale measures cognitive function in patients with schizophrenia. RBANS scores for list learning range from 0 to 40. RBANS Index scores for visual-spatial index, language index, and Total score range from 40-160. Higher scores on all these measures indicate better performance or better cognitive ability.|baseline and month 2 of treatment|||RBANS scores||Standard Deviation|Mean
750032|NCT00548470|Primary|Plasma Cotinine|cotinine level in plasma ng/ml.|baseline 1 month and 2 months|||ng/ml||Standard Deviation|Mean
750033|NCT00548470|Primary|CO Breathalyzer Level||baseline and during 2 months of treatment|||ppm (carbon monoxide parts per million)||Standard Deviation|Mean
750034|NCT00548470|Primary|Self Report of Smoking|Patients self-report of smoking cigarettes|Baseline and during 2 months of treatment|||Cigarettes||Standard Deviation|Mean
750163|NCT00542620|Primary|Glycosylated Haemoglobin A1c (HbA1c)|Measured for the ITT (Intention-to-Treat) set|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.||percentage of total haemoglobin||Standard Deviation|Mean
750035|NCT00548548|Secondary|Participants With Adverse Events|The intensity of Adverse Events (AEs) was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0 on a five-point scale from Grade 1 (Mild) to Grade 5 (Death). A serious AE (SAE) was defined as any event that is fatal, life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above.|From randomization until 3 months after last dose (up to 26 months)|Safety population, including all patients randomized and exposed to study medication (defined as any one component of the combination). Patients are assigned to treatment groups based on the treatment they actually received.||participants|||Number
750036|NCT00548548|Secondary|Participants With Disease Control|Disease control for participants with measurable disease was defined as a complete response (CR), partial response (PR) or stable disease (SD) for 6 weeks or longer, as determined by the RECIST criteria. For participants without measurable disease, disease control was defined as no disease progression for ≥ 6 weeks.|From randomization until the end of study, up to 26 months.|Intent-to-treat||participants|||Number
750037|NCT00548548|Secondary|Duration of Response|Duration of response during first line therapy is defined as the time from when response (CR or PR) was first documented to first documented disease progression or death (whichever occurs first) during first line therapy. This was only be calculated for participants who achieved a best overall response of CR or PR. Participants who did not progress or die after they had a confirmed response were censored at the date of their last tumor measurement or last follow up for progression of disease during first line therapy. Median duration of response was estimated using the Kaplan-Meier method.|From randomization to the end of study, up to 26 months|Participants with measurable disease at baseline who had a best overall response of complete response or partial response, and for whom duration of response data was available.||months||95% Confidence Interval|Median
750038|NCT00548548|Secondary|Participants With a Best Overall Response of Complete or Partial Response|Best overall response during first-line therapy is defined as the occurrence of either a confirmed complete (CR) or a partial (PR) best overall response, as determined by the RECIST criteria. CR is defined as the disappearance of all target and non-target lesions and PR is defined as at least a 30% decrease in the sum of the longest diameter of target lesions and no new or progression of non-target lesions, or the disappearance of all target lesions and persistence of one or more non-target lesion(s).|From randomization until the end of study, up to 26 months.|Measurable Disease Population, including all randomized participants with measurable disease (per RECIST) for gastric cancer at baseline. Patients were analyzed according to the treatment groups to which they were randomized.||participants|||Number
750039|NCT00548548|Secondary|Time to Disease Progression|Time to progression is defined as the time from randomization to the first occurrence of progressive disease (PD). PD was assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions, or appearance of ≥1 new lesions and/or unequivocal progression of existing non-target lesions. Patients with no PD at study completion (including those who died before PD) were censored at the date of the last tumor assessment. Median time to PD was estimated using the Kaplan-Meier method.|From randomization until disease progression; assessed every 6 weeks for the first year and every 12 weeks thereafter, up to 26 months.|Intent-to-treat||months||95% Confidence Interval|Median
750040|NCT00548548|Secondary|Progression-free Survival During First-line Therapy|Progression-free survival (PFS) during first-line therapy is defined as the time between randomization and the date of first documented disease progression or death, whichever occurs first and only if it occurs no later than 28 days after last confirmed intake of any study medication and only if it occurs before the start of non-study antineoplastic treatment. Participants who did not progress or die in this interval or were lost to follow-up were censored at the date of the last tumor assessment within this time window. Median PFS was estimated using the Kaplan-Meier method.|From randomization until 28-days after the last study treatment was administered, up to 26 months.|Intent-to treat.||months||95% Confidence Interval|Median
750041|NCT00548548|Secondary|Progression-free Survival|Progression-free survival (PFS) is defined as the time between randomization and the date of first documented disease progression or death, whichever occurs first. Patients who neither progressed nor died at the time of study completion or who were lost to follow-up were censored at the date of the last tumor assessment or last follow up for progression of disease. Median PFS was estimated using the Kaplan-Meier method.|From randomization until disease progression or death, up to 26 months.|Intent to treat||months||95% Confidence Interval|Median
750042|NCT00548548|Primary|Overall Survival|The primary efficacy endpoint for this study was overall survival (time to death), defined as the time between randomization and the date of death irrespective of the cause of death. Patients for whom no death was captured on the clinical database were censored at the most recent date they were known to be alive. Median survival was estimated by the Kaplan-Meier method.|From randomization until death, up to 26 months|The Intent-to-Treat population, including all randomized participants.||months||95% Confidence Interval|Median
750043|NCT00548691|Primary|Incidence of Treatment-emergent Serious Adverse Events (SAE's)||from Day 0 through 30 days after the last dose of study drug|||participants|||Number
750044|NCT00548717|Secondary|Overall Survival||1 year|||percentage of participants|||Number
750045|NCT00548717|Secondary|Incidence of Chronic GVHD|"Chronic GVHD will be graded according to the modified Seattle criteria. Chronic GVHD divided into limited and extensive and evaluated across the following systems: skin, cutaneous structures, liver, mouth, eyes, esophagus, intestines, lung, musculoskeletal, serous, nervous, urologic, vagina, hematopoietic, and immune.
Localized skin involvement with or without hepatic dysfunction is classified as limited disease.
Generalized skin involvement or limited disease plus eye involvement, oral involvement, hepatic dysfunction with abnormal liver histology, or involvement of any other target organ was classified as extensive disease.
Lee SJ, Vogelsang G, Flowers ME. Chronic graft‐versus‐host disease. Biol Blood Marrow Transplant.
2003;9:215‐33."|1 year|||percentage of participants|||Number
750046|NCT00548717|Secondary|Incidence of 100 Day Mortality||100 days|||percentage of participants|||Number
750790|NCT00553644|Secondary|Incidence of Adverse Events|Number of participants who experienced a maximum grade 3, 4 or 5 adverse event. The grading scales found in the revised NCI CTCAE version 4.0 was utilized for adverse event reporting|Duration of Treatment (up to 6 years)|||participants|||Number
750047|NCT00548717|Secondary|To Correlate the Serum Concentrations of Mycophenolate Mofetil and Its Metabolites With Acute GVHD Incidence|This outcome measure was presented as a comparison between incidence of Grade 0-I aGVHD and Grade II-IV aGVHD across 5 time points (Weeks 1,2,3,8, and 12).|1 year|In the Siro/MMF group, the overall number of participants analyzed was 13, however, the number of participants with the MMF level data available varies at each time point. For the Siro/MMF/Bort group, no data were analyzed due to no data available for this Outcome Measure.||ng/mL||Standard Deviation|Mean
750048|NCT00548717|Secondary|The Rate of Renal Insufficiency|"Renal function will be measured weekly after transplant for 4 weeks, at 8 weeks and then at 3 month intervals from transplantation. Sentinel renal events such as the occurrence of thrombotic microangiopathy will be noted.
The rationale for the substitution of mycophenolate mofetil for tacrolimus is to continue to prevent acute GVHD, but minimize renal toxicity after transplantation. We will thus monitor renal toxicity closely in this study. In our previous experience, the rate of grade III‐V renal toxicity by day 100 after transplantation was about 10%. Here, grade III is defined as a creatinine level between 3.1 to 6 times the normal level, grade IV is defined as a creatinine level 6 times or more the normal level, and grade V is defined as a fatality due to renal toxicity."|1 year|One patient experienced grade 5 renal toxicity||participants|||Number
750049|NCT00548717|Secondary|Donor Stem Cell Engraftment, Including Donor-host Hematopoietic Chimerism Studies Post Transplant|Engraftment of donor cells by week 4 after transplantation. Assessment of donor stem cell engraftment will include donor-host hematopoietic chimerism analyses at 4 weeks and every 3 months after transplantation. Chimerism measured from peripheral blood or from bone marrow.|30 days|||participants|||Number
750050|NCT00548717|Primary|To Determine the Rate of Grade II-IV Acute GVHD When Sirolimus and Mycophenolate Mofetil or Sirolimus, Mycophenolate Mofetil and Bortezomib is Used for GVHD Prophylaxis After Allogeneic Stem Cell Transplantation in Patients With Hematologic Malignancies||150 days|||percentage of participants|||Number
750051|NCT00548808|Secondary|Safety: Number of Participants With Serious and Non-Serious Adverse Events|Safety was assessed via serious adverse events (SAEs) and AEs, the details of which are listed in the Reported Adverse Event section.|baseline through 48 weeks|Full Analysis Set: all randomized participants who received at least one dose of study drug.||participants|||Number
750052|NCT00548808|Secondary|Change From Baseline to 48 Week Endpoint in Lipid and Cholesterol Profiles||baseline, 48 weeks|Full Analysis Set: all randomized participants who received at least one dose of study drug and had baseline and endpoint values.||millimoles/Liter (mmol/L)||Standard Error|Least Squares Mean
750053|NCT00548808|Secondary|Daily Total Insulin Dose Per Body Weight (U/kg/Day) at 16, 32, and 48 Weeks||16 weeks, 32 weeks, 48 weeks|Full Analysis Set: all randomized patients who received at least one dose of study drug.||Units of insulin/kilogram/day (U/kg/day)||Standard Deviation|Mean
750054|NCT00548808|Secondary|Daily Total Insulin Dose (U/Day) at 16, 32, and 48 Weeks||16 weeks, 32 weeks, 48 weeks|Full Analysis Set: all randomized patients who received at least one dose of study drug.||Units of insulin per day (U/day)||Standard Deviation|Mean
750055|NCT00548808|Secondary|Change From Baseline in Postprandial Blood Glucose Over Time|The change in blood glucose was evaluated by the GlycoMark™ test. GlycoMark measures levels of 1,5 anhydroglucitol (1,5 AG) in serum or plasma, allowing for the short- to intermediate-term monitoring of glycemic control in patients with diabetes. When 1,5 AG values decrease, serum glucose levels increase.|Baseline, 16 weeks, 32 weeks, 48 weeks|Per-protocol set: randomized; no entry criteria violations; completed >=32 weeks of study; no systemic glucocorticoid therapy >14 cumulative days during study.||millimoles per liter||Standard Error|Least Squares Mean
750056|NCT00548808|Secondary|7-point Self-monitored Blood Glucose Profiles||Baseline, 16 weeks, 32 weeks, 48 weeks|Per-protocol set: randomized; no entry criteria violations; completed >=32 weeks of study; no systemic glucocorticoid therapy >14 cumulative days during study.||millimoles per liter (mmol/L)||Standard Deviation|Mean
750057|NCT00548808|Secondary|Percentage of Patients Achieving HbA1c <6.5% and <7% Over Time||16 weeks, 32 weeks, 48 weeks|Per-protocol set: randomized; no entry criteria violations; completed >=32 weeks of study; no systemic glucocorticoid therapy >14 cumulative days during study.||percentage of participants|||Number
750058|NCT00548808|Secondary|Change in Hemoglobin A1c (HbA1c) Over Time||Baseline, 16 Weeks, 32 Weeks, 48 Weeks|Per-protocol set: randomized, no entry criteria violations, completed >=32 weeks of study, and no systemic glucocorticoid therapy for >14 cumulative days during study.||percent (%) glycated hemoglobin||Standard Error|Least Squares Mean
750059|NCT00548808|Primary|Change From Baseline to 48 Week Endpoint in Hemoglobin A1c (HbA1c)||Baseline, 48 weeks|Per-protocol set: randomized, no entry criteria violations, completed >=32 weeks of study, and no systemic glucocorticoid therapy for >14 cumulative days during study. Last observation carried forward.||percent (%) glycated hemoglobin||Standard Error|Least Squares Mean
750060|NCT00548847|Secondary|Overall Survival at 6 Months (Evaluate Overall Responses; Perform Lab Experiments to Test Hypothesis That Exposure to Interferon-alpha and GM-CSF Up-regulates Co-stimulatory Molecule Expression on Relapsed Acute Leukemia Cells)||6 months after cytokine treatment|||participants|||Number
750061|NCT00548847|Primary|Efficacy of GM-CSF and Pegylated Interferon-alpha 2b When Administered to Patients With AML, ALL, Blast Phase CML, and MDS Relapse After Allogeneic Transplantation, Defined as Progression-free Survival of > 33% at 3 Months|Efficacy is defined as progression-free survival of > 33% at 3 months. This is based on our retrospective data on 10% 3 month survival for relapsed patients. Progression is defined an an increase in blasts in blood or marrow by 50% compared to baseline with at least 20% of all cells being blasts at the time of assessment.|3 months after cytokine treatment|||percentage of progression-free patients|||Number
750062|NCT00548860|Primary|Evaluate the Safety of the Maximum Administered Dose, 15 mg/kg (up to a Maximum 1,000 mg) of FCM Compared to SMC.|Evaluate the safety of the maximum administered dose, 15 mg/kg (up to a maximum 1,000 mg) of FCM compared to SMC. The primary safety endpoint was the incidence of Serious Adverse Events (SAE's).|From Day 0 through 30 days after the last dose of study drug.|||participants|||Number
750063|NCT00548886|Secondary|Determine Interobserver Variability When Measuring QT Intervals|Two pediatric electrophysiologists were given photocopies of rhythm strips obtained from the electrocardiograms and the electrophysiologists will then take four separate measurements of the QT interval from each rhythm strip. Interobserver variability was measured between the two electrophysiologists and their measurements on the same rhythm strip. False positive results will be based on measurement error.|During enrollment period||||||
750064|NCT00548886|Primary|Percentage of Subjects With a Positive Result in Absolute QT Interval|QT interval refers to the time interval on the standard electrocardiogram from the beginning of the QRS complex to the end of the T wave. Each participant had four QT intervals measured at each timepoint and the average was calculated for each patient at each timepoint for an absolute QT interval. Lengthening of the absolute QT interval greater than 30 milliseconds on low dose epinephrine infusion would be considered a positive result.|35 minutes|Data not analyzed due to study termination|||||
750065|NCT00549055|Secondary|Number of Participants Who Received Other Concomitant Age Related Macular Degeneration (AMD) Treatments|Derived by whether a participant took any other AMD treatments at any time (at any Study Treatment Visit).|Months 3, 6, 9 and 12|FAS||Participants|||Number
750066|NCT00549055|Secondary|Frequency of Macugen Administration|Average frequency of Macugen administration per participant calculated as: (number of Macugen injections administered per participant – 1)/ duration of treatment.|Baseline up to 28.4 months|FAS||Weeks per injection||Standard Deviation|Mean
750067|NCT00549055|Secondary|Duration of Treatment|Duration of treatment per participant calculated as: date of injection (for the last injection of Macugen) minus date of injection (for the first injection of Macugen).|Baseline up to 28.4 months|FAS||Months||Standard Deviation|Mean
750068|NCT00549055|Secondary|Number of Participants With Change in VA: Worsening|Investigator's clinical judgement as Worsening in status of vision as compared to the previous Macugen injection, determined from measurement difference between the VA scores at the 2 visits.|Months 3, 6, 9 and 12|FAS; n= number of participants with analyzable data.||Participants|||Number
750069|NCT00549055|Secondary|Number of Participants With Change in VA: Stabilization|Investigator's clinical judgement as Stabilization in status of visual acuity as compared to the previous Macugen injection, determined from measurement difference between the VA scores at the 2 visits.|Months 3, 6, 9 and 12|FAS; n= number of participants with analyzable data.||Participants|||Number
750070|NCT00549055|Secondary|Number of Participants With Change in VA: Improvement|Investigator's clinical judgement of Improvement in status of vision as compared to the previous Macugen injection, calculated from measurement of the difference between the VA scores at the 2 visits.|Months 3, 6, 9 and 12|FAS; n= number of participants with analyzable data.||Participants|||Number
750071|NCT00549055|Primary|Change From Baseline to Final Visit in Visual Acuity (VA) Score|Best corrected VA score, assessed on the scale over time (best corrected VA score at Final Visit minus best corrected VA score at Baseline). Lower scores represent poorer eyesight and higher scores represent better eyesight with a value of 1 representing normal eyesight. A positive change in score represents an improvement in sight.|Baseline, Month 24 or Early Termination|The Full Analysis Set (FAS) was derived from the set of all enrolled participants who were administered at least 1 injection of the study medication and had at least 1 post Baseline efficacy measurement. Participants analyzed refers to number of participants with analyzable data.||Scores on scale||Standard Deviation|Mean
750072|NCT00549172|Secondary|Pain at Rest (VAS)|Knee pain at rest (during the preceding week) was assessed on a rating scale of 0 to 10, with 0 denoting no pain and 10 denoting extreme pain.|One year|||units on a scale||95% Confidence Interval|Mean
750073|NCT00549172|Secondary|15-D (General Quality of Life -Assessment Tool)|The 15D instrument is a generic health-related quality-of-life instrument comprising 15 dimensions. The maximum 15D score is 1 (full health), and the minimum score is 0 (death).|One year|||units on a scale||95% Confidence Interval|Mean
750074|NCT00549172|Primary|WOMET (Western Ontario Meniscal Tear -Disease Specific Quality of Life -Assessment Tool)|The Western Ontario Meniscal Evaluation Tool (WOMET) contains 16 items addressing three domains: 9 items addressing physical symptoms; 4 items addressing disabilities with regard to sports, recreation, work, and lifestyle; and 3 items addressing emotions. The score indicates the percentage of a normal score; therefore, 100 is the best possible score, and 0 is the worst possible score.|One year|||units on a scale||95% Confidence Interval|Mean
750075|NCT00549172|Primary|Pain After Exercise (VAS)|Knee pain after exercise (during the preceding week) was assessed on a rating scale of 0 to 10, with 0 denoting no pain and 10 denoting extreme pain.|One year|||units on a scale||95% Confidence Interval|Mean
750076|NCT00549172|Primary|The Lysholm Knee Score|The Lysholm knee score is based on an eight-item questionnaire designed to evaluate knee function and symptoms in activities of daily living. Scores range from 0 to 100; higher scores indicate less severe symptoms.|One year|||units on a scale||95% Confidence Interval|Mean
750077|NCT00549198|Other Pre-specified|Exploratory Analysis of Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) at Week 96|Bone biomarkers were analyzed using blood samples collected from participants at baseline and Week 96. Bone biomarkers may be an indicator of bone turnover.|Baseline, Week 96|Safety Biomarker Population. Some participants had withdrawn by Week 96.||ug/L||95% Confidence Interval|Geometric Mean
750078|NCT00549198|Other Pre-specified|Exploratory Analysis of Change From Baseline in Osteocalcin at Week 96|Bone biomarkers were analyzed using blood samples collected from participants at baseline and Week 96. Bone biomarkers may be an indicator of bone turnover.|Baseline, Week 96|Safety Biomarker Population. Some participants had withdrawn by Week 96.||ug/L||95% Confidence Interval|Geometric Mean
750079|NCT00549198|Other Pre-specified|Exploratory Analysis of Change From Baseline in Type 1 Collagen Cross-linked C-telopeptide at Week 96|Bone biomarkers were analyzed using blood samples collected from participants at baseline and Week 96. Bone biomarkers may be an indicator of bone turnover.|Baseline, Week 96|Safety Biomarker Population. Some participants had withdrawn by Week 96.||nanograms per Liter (ng/L)||95% Confidence Interval|Geometric Mean
750080|NCT00549198|Other Pre-specified|Exploratory Analysis of Change From Baseline in Procollagen Type 1 Amino-terminal Propeptide (P1NP) at Week 96|P1NP is a bone biomarker that was analyzed using blood samples collected from participants at baseline and Week 96. Bone biomarkers may be an indicator of bone turnover.|Baseline, Week 96|Safety Biomarker Population. Some participants had withdrawn by Week 96.||micrograms per Liter (ug/L)||95% Confidence Interval|Geometric Mean
750092|NCT00549198|Secondary|Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 24|HIV-1 RNA level (viral load) is a strong predictor of the rate of HIV disease progression. It was measured from plasma (participant blood samples) taken at all visits throughout the study. HIV, human immunodeficiency virus; RNA, ribonucleic acid. Viral load is a measure of the severity of the HIV infection.|Week 24|ITT-E Population. Failures and missing values are derived according to the Time to Loss of Virologic Response (TLOVR) Food and Drug Administration (FDA) algorithm.||participants|||Number
750081|NCT00549198|Other Pre-specified|Exploratory Analysis of Change From Baseline in Retinol Binding Protein (RBP) as a Ratio to Urine Creatinine at Week 96|Renal biomarkers were analyzed using urine samples collected from participants at baseline and Week 96. Renal biomarkers may be an indicator of various aspects of kidney function. The ratio was calculated by dividing the change from baseline RBP value by the urine creatinine value. RBP, retinol binding protein (measured in micrograms per millimole [ug/mmol]).|Baseline, Week 96|Safety Biomarker Population: all randomized participants who received at least one dose of study medication and had at least one parameter measured at Baseline and at least one post-baseline visit. Some participants had withdrawn by Week 96.||ratio||95% Confidence Interval|Geometric Mean
750082|NCT00549198|Other Pre-specified|Exploratory Analysis of Change From Baseline in N-acetyl-B-glucosaminidase (NAG) as a Ratio to Urine Creatinine at Week 96|Renal biomarkers were analyzed using urine samples collected from participants at baseline and Week 96. Renal biomarkers may be an indicator of various aspects of kidney function. The ratio was calculated by dividing the change from baseline NAG value by the urine creatinine value. NAG, N-acetyl-B-glucosaminidase (measured in micromoles per hour per millimole [umol/h/mmol]).|Baseline, Week 96|Safety Biomarker Population: all randomized participants who received at least one dose of study medication and had at least one parameter measured at Baseline and at least one post-baseline visit. Some participants had withdrawn by Week 96.||ratio||95% Confidence Interval|Geometric Mean
750083|NCT00549198|Other Pre-specified|Exploratory Analysis of Change From Baseline in Beta 2 Microglobulin (B2M) as a Ratio to Urine Creatinine at Week 96|Renal biomarkers were analyzed using urine samples collected from participants at baseline and Week 96. Renal biomarkers may be an indicator of various aspects of kidney function. The ratio was calculated by dividing the change from baseline B2M value by the urine creatinine value. B2M, beta 2 microglobulin (measured in mg/mmol).|Baseline, Week 96|Safety Population. Some participants had withdrawn by Week 96.||ratio||95% Confidence Interval|Geometric Mean
750084|NCT00549198|Other Pre-specified|Exploratory Analysis of Change From Baseline in Albumin as a Ratio to Urine Creatinine at Week 96|Renal biomarkers were analyzed using urine samples collected from participants at baseline and Week 96. Renal biomarkers may be an indicator of various aspects of kidney function. The ratio was calculated by dividing the change from baseline albumin value by the urine creatinine value. Albumin is measured in milligrams per millimole (mg/mmol).|Baseline, Week 96|Safety Biomarker Population: all randomized participants who received at least one dose of study medication and had at least one parameter measured at Baseline and at least one post-baseline visit. Some participants had withdrawn by Week 96.||ratio||95% Confidence Interval|Geometric Mean
750085|NCT00549198|Secondary|"Number of Participants Who Indicated Yes or No to the Question of Whether Unplanned Healthcare Resources Were Utilized"|Participants were asked at each visit whether or not they utilized unplanned healthcare resources.|Baseline to Week 96|ITT-E Population. The number of participants analyzed differed by visit because some had withdrawn during the study and some did not have an assessment performed.||participants|||Number
750086|NCT00549198|Secondary|Number of Participants Classified as Protocol-defined Failures With Treatment-emergent Resistance to Study Drug in the Indicated Viruses at Week 96|Viral resistance was measured using blood samples collected from participants throughout the study. NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor. Virological failure was defined as any one of: participant does not achieve a 1 log10 copies (cop)/mL decrease in plasma HIV-1 RNA by Week (Wk) 4, or has two consecutive plasma HIV-1 RNA measures >=400 cop/mL separated by at least 2-4 wk after being previously <=400 cop/mL on/after Wk 4, or has two consecutive plasma HIV-1 RNA measures >400 cop/mL separated by at least 2-4 wk on/after Wk 24.|Week 96|On-Treatment Resistance: all participants who fulfilled the definition of protocol-defined virological failure (VF) who had paired baseline and VF genotypic data for analysis. One ABC/3TC participant took prohibited medication that potentially lowered efavirenz levels just prior to VF, allowing for the emergence of unexpected NRTI resistance.||participants|||Number
750087|NCT00549198|Secondary|Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 96|CD4+ counts are used to monitor the progression of HIV disease and the strength of the immune system. The number of CD4+ cells decreases as HIV disease progresses. Cell counts were measured from participant blood samples taken throughout the study.|Baseline, Week 96|ITT-E Population. Some participants had withdrawn by Week 96.||cells/mm^3||Inter-Quartile Range|Median
750088|NCT00549198|Secondary|Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 48|CD4+ counts are used to monitor the progression of HIV disease and the strength of the immune system. The number of CD4+ cells decreases as HIV disease progresses. Cell counts were measured from participant blood samples taken throughout the study.|Baseline, Week 48|ITT-E Population. Some participants had withdrawn by Week 48.||cells/mm^3||Inter-Quartile Range|Median
750089|NCT00549198|Secondary|Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 24|CD4+ counts are used to monitor the progression of HIV disease and the strength of the immune system. The number of CD4+ cells decreases as HIV disease progresses. Cell counts were measured from participant blood samples taken throughout the study.|Baseline, Week 24|ITT-E Population. Some participants had withdrawn by Week 24.||cells/millimeters cubed (mm^3)||Inter-Quartile Range|Median
750090|NCT00549198|Secondary|Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 96|HIV-1 RNA level (viral load) is a strong predictor of the rate of HIV disease progression. It was measured from plasma (participant blood samples) taken at all visits throughout the study. HIV, human immunodeficiency virus; RNA, ribonucleic acid. Viral load is a measure of the severity of the HIV infection.|Week 96|ITT-E Population. Failures and missing values are derived according to the Time to Loss of Virologic Response (TLOVR) Food and Drug Administration (FDA) algorithm.||participants|||Number
750091|NCT00549198|Secondary|Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 48|HIV-1 RNA level (viral load) is a strong predictor of the rate of HIV disease progression. It was measured from plasma (participant blood samples) taken at all visits throughout the study. HIV, human immunodeficiency virus; RNA, ribonucleic acid. Viral load is a measure of the severity of the HIV infection.|Week 48|ITT-E Population. Failures and missing values are derived according to the Time to Loss of Virologic Response (TLOVR) Food and Drug Administration (FDA) algorithm.||participants|||Number
750844|NCT00554463|Secondary|Incidence of Dose Modifications or Treatment Delays||At the completion of all treatment, approximately 80 days||||||
763687|NCT00670540|Secondary|Percentage of Participants Who Developed Major Bleeding Events||at 3 years|||percentage of participants||95% Confidence Interval|Number
750093|NCT00549198|Secondary|Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96|The DAIDS toxicity table provides descriptive terminology for grading the severity of adult adverse events. Laboratory grades also provide ranges for each parameter. Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: potentially life-threatening. LDL, low-density lipid; HDL, high-density lipid. Treatment emergent refers to any toxicity that was not present prior to the start of study drug therapy.|Week 96|Safety Population||participants|||Number
750094|NCT00549198|Secondary|Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48|The DAIDS toxicity table provides descriptive terminology for grading the severity of adult adverse events. Laboratory grades also provide ranges for each parameter. Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: potentially life-threatening. LDL, low-density lipid; HDL, high-density lipid. Treatment emergent refers to any toxicity that was not present prior to the start of study drug treatment.|Week 48|Safety Population||participants|||Number
750095|NCT00549198|Secondary|Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24|The DAIDS toxicity table provides descriptive terminology for grading the severity of adult adverse events. Laboratory grades also provide ranges for each parameter. Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: potentially life-threatening. LDL, low-density lipid; HDL, high-density lipid. Treatment emergent refers to any toxicity that was not present prior to the start of study drug treatment.|Week 24|Safety Population||participants|||Number
750096|NCT00549198|Secondary|Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 96|Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <150 mg/dL, normal; 150->200 mg/dL, borderline high; 200-<500 mg/dL, high;>= 500 mg/dL, very high.|Baseline, Week 96|Safety Population||participants|||Number
750097|NCT00549198|Secondary|Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 48|Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <150 mg/dL, normal; 150-<200 mg/dL, borderline high; 200-<500 mg/dL, high; >=500 mg/dL, very high.|Baseline, Week 48|Safety Population||participants|||Number
750098|NCT00549198|Secondary|Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 24|Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <150 mg/dL, normal; 150-<200 mg/dL, borderline high; 200-<500 mg/dL, high; >=500 mg/dL, very high.|Baseline, Week 24|Safety Population||participants|||Number
750099|NCT00549198|Secondary|Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 96|Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <40 mg/dL, low; 40-<60 mg/dL, normal; >=60 mg/dL, high.|Baseline, Week 96|Safety Population||participants|||Number
750100|NCT00549198|Secondary|Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 48|Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <40 mg/dL, low; 40-<60 mg/dL, normal; >=60 mg/dL, high.|Baseline, Week 48|Safety Population||participants|||Number
750101|NCT00549198|Secondary|Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 24|Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <40 mg/dL, low; 40-<60 mg/dL, normal; >=60 mg/dL, high.|Baseline, Week 24|Safety Population||participants|||Number
750102|NCT00549198|Secondary|Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96|Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <100 mg/dL, optimal; 100-<130 mg/dL, near/above optimal; 130-<160 mg/dL, borderline high; 160-<190 mg/dL, high; >=190 mg/dL, very high.|Baseline, Week 96|Safety Population||participants|||Number
750103|NCT00549198|Secondary|Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48|Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <100 mg/dL, optimal; 100-<130 mg/dL, near/above optimal; 130-<160 mg/dL, borderline high; 160-<190 mg/dL, high; >=190 mg/dL, very high.|Baseline, Week 48|Safety Population||participants|||Number
750104|NCT00549198|Secondary|Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24|Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <100 mg/dL, optimal; 100-<130 mg/dL, near/above optimal; 130-<160 mg/dL, borderline high; 160-<190 mg/dL, high; >=190 mg/dL, very high.|Baseline, Week 24|Safety Population||participants|||Number
750105|NCT00549198|Secondary|Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 96|Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <200 mg/dL, desirable; 200-<240 mg/dL, borderline high; >=240 mg/dL, high. mg, milligram; dL, deciliter.|Baseline, Week 96|Safety Population||participants|||Number
750106|NCT00549198|Secondary|Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 48|Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <200 mg/dL, desirable; 200-<240 mg/dL, borderline high; >=240 mg/dL, high. mg, milligram; dL, deciliter.|Baseline, Week 48|Safety Population||participants|||Number
750845|NCT00554463|Secondary|Incidence of Grade 4 Neutropenia or Grades 3-4 Febrile Neutropenia Episodes During Adjuvant Chemotherapy as Assessed by NCI CTCAE v 3.0||At the completion of all treatment, approximately 80 days||||||
750107|NCT00549198|Secondary|Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 24|Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <200 mg/dL, desirable; 200-<240 mg/dL, borderline high; >=240 mg/dL, high. mg, milligram; dL, deciliter.|Baseline, Week 24|Safety Population||participants|||Number
750108|NCT00549198|Secondary|Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 96|An adverse event was any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events occurring in two or more participants are presented.|Baseline to Week 96|Safety Population: all randomized participants who received at least one dose of study medication||participants|||Number
750109|NCT00549198|Secondary|Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 48|An adverse event was any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events occurring in two or more participants are presented.|Baseline to Week 48|Safety Population: all randomized participants who received at least one dose of study medication||participants|||Number
750110|NCT00549198|Secondary|Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 24|An adverse event was any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events occurring in two or more participants are presented.|Baseline to Week 24|Safety Population: all randomized participants who received at least one dose of study medication||participants|||Number
750111|NCT00549198|Secondary|Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 96|"The T-score is a radiographic diagnosis that compares bone mineral density (BMD) to that of a normal, healthy, 30-year-old female. The lower the T-score, the lower the BMD. A T-score of +1 to -1 is normal. A T-score decrease of -1 indicates a 10%-15% decrease in BMD."|Week 96|ITT-E Population. Some participants had withdrawn by Week 96.||participants|||Number
750112|NCT00549198|Secondary|Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 48|"The T-score is a radiographic diagnosis that compares bone mineral density (BMD) to that of a normal, healthy, 30-year-old female. The lower the T-score, the lower the BMD. A T-score of +1 to -1 is normal. A T-score decrease of -1 indicates a 10%-15% decrease in BMD."|Week 48|ITT-E Population. Some participants had withdrawn by Week 48.||participants|||Number
750113|NCT00549198|Secondary|Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 24|"The T-score is a radiographic diagnosis that compares bone mineral density (BMD) to that of a normal, healthy, 30-year-old female. The lower the T-score, the lower the BMD. A T-score of +1 to -1 is normal. A T-score decrease of -1 indicates a 10%-15% decrease in BMD."|Week 24|ITT-E Population. Some participants had withdrawn by Week 24.||participants|||Number
750114|NCT00549198|Secondary|Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 96|BMD is a measure of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones.|Baseline, Week 96|ITT-E Population. Some participants had withdrawn by Week 96/did not have a DXA scan performed. DXA, dual energy x-ray absorptiometry.||participants|||Number
750115|NCT00549198|Secondary|Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 48|BMD is a measure of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones.|Baseline, Week 48|ITT-E Population. Some participants had withdrawn by Week 48/did not have a DXA scan performed. DXA, dual energy x-ray absorptiometry.||participants|||Number
750116|NCT00549198|Secondary|Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 24|BMD is a measure of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones.|Baseline, Week 24|ITT-E Population. Some participants had withdrawn by Week 24/did not have a DXA scan performed. DXA, dual energy x-ray absorptiometry.||participants|||Number
750117|NCT00549198|Secondary|Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 96|BMD is a measure (grams per cm^3) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale.|Baseline, Week 96|ITT-E Population||percent change||Standard Error|Mean
750118|NCT00549198|Secondary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 96|BMD is a measure (grams per cm^3) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale.|Baseline, Week 96|ITT-E Population||percent change||Standard Error|Mean
750119|NCT00549198|Secondary|Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 48|BMD is a measure (grams per cm^3) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale.|Baseline, Week 48|ITT-E Population||percent change||Standard Error|Mean
750120|NCT00549198|Secondary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 48|BMD is a measure (grams per cm^3) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale.|Baseline, Week 48|ITT-E Population||percent change||Standard Error|Mean
750121|NCT00549198|Secondary|Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 24|BMD is a measure (grams per cm^3) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale.|Baseline, Week 24|ITT-E Population||percent change||Standard Error|Mean
750122|NCT00549198|Secondary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 24|BMD is a measure (grams [g] per centimeters cubed [cm^3]) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale.|Baseline, Week 24|ITT-E Population||percent change||Standard Error|Mean
750123|NCT00549198|Secondary|Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 96|Normal: GFR >=60 mL/min/1.73 m^2 and creatinine ratio <=200 mg/g GFR; Stage 1: GFR >=90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 2: GFR >=60-<90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 3: GFR >=30-<60 mL/min/1.73 m^2; Stage 4: GFR >=15-<30 mL/min/1.73 m^2; Stage 5: GFR <15 mL/min/1.73 m^2. mL, milliliter; min, minute; m^2, meters squared; mg, milligram; g, gram.|Baseline, Week 96|ITT-E Population. Some participants had withdrawn by Week 96.||participants|||Number
750124|NCT00549198|Secondary|Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 48|Normal: GFR >=60 mL/min/1.73 m^2 and creatinine ratio <=200 mg/g GFR; Stage 1: GFR >=90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 2: GFR >=60-<90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 3: GFR >=30-<60 mL/min/1.73 m^2; Stage 4: GFR >=15-<30 mL/min/1.73 m^2; Stage 5: GFR <15 mL/min/1.73 m^2. mL, milliliter; min, minute; m^2, meters squared; mg, milligram; g, gram.|Baseline, Week 48|ITT-E Population. Some participants had withdrawn by Week 48.||participants|||Number
750125|NCT00549198|Secondary|Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 24|Normal: GFR >=60 mL/min/1.73 m^2 and creatinine ratio <=200 mg/g GFR; Stage 1: GFR >=90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 2: GFR >=60-<90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 3: GFR >=30-<60 mL/min/1.73 m^2; Stage 4: GFR >=15-<30 mL/min/1.73 m^2; Stage 5: GFR <15 mL/min/1.73 m^2. mL, milliliter; min, minute; m^2, meters squared; mg, milligram; g, gram.|Baseline, Week 24|ITT-E Population. Some participants had withdrawn by Week 24.||participants|||Number
750126|NCT00549198|Secondary|Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 96|mL, milliliter; min, minute; m^2, meters squared|Baseline, Week 96|ITT-E Population. Some participants had withdrawn by Week 96.||participants|||Number
750127|NCT00549198|Secondary|Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 48|mL, milliliter; min, minute; m^2, meters squared|Baseline, Week 48|ITT-E Population. Some participants had withdrawn by Week 48.||participants|||Number
750128|NCT00549198|Secondary|Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73 m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72 m^2, >=10%, and >=20% at Week 24|mL, milliliter; min, minute; m^2, meters squared|Baseline, Week 24|ITT-E Population. Some participants had withdrawn from the study by Week 24.||participants|||Number
750129|NCT00549198|Secondary|Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 96|Change from baseline was calculated as the Week 96 value minus the baseline value. Cockcroft-Gault is an equation (calculation) used to estimate GFR based on serum creatinine, weight, and gender. GFR = (140 - age) * (mass in kg) * (0.85 if female) divided by 72 * serum creatinine in mg/dL. mg, milligram; dL, deciliter; kg, kilogram.|Baseline, Week 96|ITT-E Population||mL/min||Standard Error|Mean
750130|NCT00549198|Secondary|Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 48|Change from baseline was calculated as the Week 48 value minus the baseline value. Cockcroft-Gault is an equation (calculation) used to estimate GFR based on serum creatinine, weight, and gender. GFR = (140 - age) * (mass in kg) * (0.85 if female) divided by 72 * serum creatinine in mg/dL. mg, milligram; dL, deciliter; kg, kilogram.|Baseline, Week 48|ITT-E Population||mL/min||Standard Error|Mean
750131|NCT00549198|Secondary|Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 24|Change from baseline was calculated as the Week 24 value minus the baseline value. Cockcroft-Gault is an equation (calculation) used to estimate GFR based on serum creatinine, weight, and gender. GFR = (140 - age) * (mass in kg) * (0.85 if female) divided by 72 * serum creatinine in mg/dL. mg, milligram; dL, deciliter; kg, kilogram; CG, Cockcroft-Gault.|Baseline, Week 24|ITT-E Population||mL/min||Standard Error|Mean
750132|NCT00549198|Secondary|Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 96|Change from baseline was calculated as the Week 96 value minus the baseline value. GFR is a measure of the rate at which blood is filtered by the kidney. MDRD is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine, age, race, and gender. GFR (mL/min/1.73 m^2) = 175 * (Scr)^-1.154 * (Age)^-0.203 * (0.742 if female) * (1.212 if African American) (conventional units). mL, milliliters; min, minute; m^s, meters squared; Scr, serum creatinine.|Baseline, Week 96|ITT-E Population||mL/min/1.73m^2||Standard Error|Mean
750133|NCT00549198|Secondary|Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 24|Change from baseline was calculated as the Week 24 value minus the baseline value. GFR is a measure of the rate at which blood is filtered by the kidney. MDRD is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine, age, race, and gender. GFR (mL/min/1.73 m^2) = 175 * (Scr)^-1.154 * (Age)^-0.203 * (0.742 if female) * (1.212 if African American) (conventional units). mL, milliliters; min, minute; m^2, meters squared; Scr, serum creatinine.|Baseline, Week 24|ITT-E Population||mL/min/1.73m^2||Standard Error|Mean
750147|NCT00542620|Secondary|Pharmacokinetics: Cmax of Insulin Aspart|The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.||pmol/L||Standard Deviation|Median
751023|NCT00555620|Secondary|Tmax for CAP||Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; number of participants analyzed (N): participants with evaluable data||hr||Full Range|Median
750134|NCT00549198|Primary|Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 48|Change from baseline was calculated as the Week 48 value minus the baseline value. GFR is a measure of the rate at which blood is filtered by the kidney. MDRD is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine, age, race, and gender. GFR (mL/min/1.73 m^2) = 175 * (Scr)^-1.154 * (Age)^-0.203 * (0.742 if female) * (1.212 if African American) (conventional units). mL, milliliters; min, minute; m^2, meters squared; Scr, serum creatinine; BMI, body mass index.|Baseline, Week 48|Intent-to-Treat-Exposed (ITT-E) Population: all randomized participants who received at least one dose of study medication||milliliters per minute (mL/min)/1.73 m^2||Standard Error|Mean
750135|NCT00542620|Secondary|"Percentage of Children Assessing Insulin Therapy Injection Pain as Very Happy Face"|Via a paper diary, the children perceived insulin therapy injection pain by using a four-grade facial visual analogue scale (VAS): very sad face, sad face, happy face or very happy face.|Week 0 and Week 8|All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subjects are analysed based on treatments actually received.||percentage of subjects|||Number
750136|NCT00542620|Secondary|"Percentage of Children Assessing Insulin Therapy Injection Pain as Happy Face"|Via a paper diary, the children perceived insulin therapy injection pain by using a four-grade facial visual analogue scale (VAS): very sad face, sad face, happy face or very happy face.|Week 0 and week 8|All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subjects are analysed based on treatments actually received.||percentage of subjects|||Number
750137|NCT00542620|Secondary|"Percentage of Children Assessing Insulin Therapy Injection Pain as Sad Face"|Via a paper diary, the children perceived insulin therapy injection pain by using a four-grade facial visual analogue scale (VAS): very sad face, sad face, happy face or very happy face.|Week 0 and Week 8|All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subjects are analysed based on treatments actually received.||percentage of subjects|||Number
750138|NCT00542620|Secondary|Incidence of Hypoglycaemic Episodes - Glycaemia Above or Equal to 0.56 g/L|Number of “symptoms only” hypoglycaemic episodes from Week 0 to Week 8, defined as self-measurement plasma glucose higher than or equal to 3.1 mmol/L (56 mg/dL) or no plasma glucose measurement and the child is able to treat her/himself.|Weeks 0-8|All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subjects are analysed based on treatments actually received.||episodes|||Number
750139|NCT00542620|Secondary|Incidence of Hypoglycaemic Episodes - Glycaemia Below 0.56 g/L|Number of minor hypoglycaemic episodes from Week 0 to Week 8, defined as self-measurement plasma glucose below 3.1 mmol/L (56 mg/dL) and the child is able to treat her/himself.|Weeks 0-8|All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subjects are analysed based on treatments actually received.||episodes|||Number
750140|NCT00542620|Secondary|Incidence of Hypoglycaemic Episodes - All Episodes|Number of hypoglycaemic episodes from Week 0 to Week 8, defined as self-measurement plasma glucose less than 56 mg/dL (3.1 mmol/L). Classified as major, minor or symptoms only. Major if unable to treat her/himself (given the age of the study population, the definition of major hypoglycemia was to be adapted through the investigator’s judgment). Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L (56 mg/dL). Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|Weeks 0-8|All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subjects are analysed based on treatments actually received.||episodes|||Number
750141|NCT00542620|Secondary|Body Mass Index (BMI) Z Score|Z score of BMI index. To estimate the growth of children, standardised mean BMI values were calculated for each month of age and for each sex|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.||Z-score||Standard Deviation|Mean
750142|NCT00542620|Secondary|Weight Z Score|Z score of weight. To estimate the growth of children, standardised mean weight values were calculated for each month of age and for each sex|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.||Z-score||Standard Deviation|Mean
750143|NCT00542620|Secondary|Pharmacokinetics: Terminal Phase Elimination Half-life (T½) - Parameter of Insulin Aspart|The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.||hours||Standard Deviation|Median
750144|NCT00542620|Secondary|Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to Infinity of Insulin Aspart|The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.||pmol.h/L||Standard Deviation|Median
750145|NCT00542620|Secondary|Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to the Time of the Last Measured Level of Insulin Aspart|The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.||pmol.h/L||Standard Deviation|Median
750146|NCT00542620|Secondary|Pharmacokinetics: Tmax of Insulin Aspart|The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.||hours||Standard Deviation|Median
752641|NCT00561600|Secondary|Analysis of Metal Ion Release - Serum Chromium|Serum Chromium|pre-operative|Metal ion sub-study was limited to two sites. All participants with available data are presented below.||ug/L||Full Range|Median
750148|NCT00542620|Secondary|Pharmacokinetics: Terminal Phase Elimination Half-life (T½) - Parameter of Insulin Detemir|The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. CGMS® data not available/sufficient for pre-study evaluation in five subjects or at post-study evaluation in four subjects||hours||Standard Deviation|Median
750149|NCT00542620|Secondary|Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to Infinity of Insulin Detemir|The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation. CGMS® data not available/sufficient for pre-study evaluation in five subjects or at post-study evaluation in four subjects||pmol.h/L||Standard Deviation|Median
750150|NCT00542620|Secondary|Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to the Time of the Last Measured Level of Insulin Detemir|The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.||pmol.h/L||Standard Deviation|Median
750151|NCT00542620|Secondary|Pharmacokinetics: Tmax of Insulin Detemir|The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.||hours||Standard Deviation|Median
750152|NCT00542620|Secondary|Pharmacokinetics: Cmax of Insulin Detemir|The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.||pmol/L||Standard Deviation|Median
750153|NCT00542620|Secondary|Pharmacokinetics: Terminal Phase Elimination Half-life (T½) - Parameter of Free Insulin|The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation. CGMS® data not available/sufficient for pre-study evaluation in five subjects or at post-study evaluation in four subjects||hours||Standard Deviation|Median
750154|NCT00542620|Secondary|Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to Infinity of Free Insulin|The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation. CGMS® data not available/sufficient for pre-study evaluation in five subjects or at post-study evaluation in four subjects.||pmol.h/L||Standard Deviation|Median
750155|NCT00542620|Secondary|Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to the Time of the Last Measured Level of Free Insulin|The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.||pmol.h/L||Standard Deviation|Median
750156|NCT00542620|Secondary|Pharmacokinetics: Tmax of Free Insulin|The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.||hours||Standard Deviation|Median
750157|NCT00542620|Secondary|Pharmacokinetics: Cmax of Free Insulin|The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2 hours (hrs), T2.5hrs, T3hrs, T3.5hrs, T4hrs|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.||pmol/L||Standard Deviation|Median
750158|NCT00542620|Secondary|Self-measured Plasma Glucose Profile (After Dinner)||Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation. CGMS® data not available/sufficient for pre-study evaluation in five subjects or at post-study evaluation in four subjects.||mg/dL||Standard Deviation|Mean
750159|NCT00542620|Secondary|Self-measured Plasma Glucose Profile (Before Dinner)||Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.||mg/dL||Standard Deviation|Mean
750160|NCT00542620|Secondary|Self-measured Plasma Glucose Profile (After Breakfast)||Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.||mg/dL||Standard Deviation|Mean
750161|NCT00542620|Secondary|Self-measured Plasma Glucose Profile (Before Breakfast)||Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.||mg/dL||Standard Deviation|Mean
750162|NCT00542620|Secondary|Fructosamine||Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.||mmol/L||Standard Deviation|Mean
752642|NCT00561600|Secondary|Analysis of Metal Ion Release - Serum Cobalt|Serum Cobalt|Pre-operative|Metal ion sub-study was limited to two sites. All participants with available data are presented below.||ug/L||Full Range|Median
750164|NCT00542620|Primary|Glycosylated Haemoglobin A1c (HbA1c)|Measured for the Per Protocol (PP) set|Week 0 and Week 8|Per Protocol (PP) analysis set consists of all the ITT (Intention-to-Treat) subjects who did not present any significant protocol deviations that could potentially affect the efficacy results. One subject was excluded from PP as subject received separate injections despite being randomised to receive mixed injections.||percentage of total haemoglobin||Standard Deviation|Mean
750165|NCT00542789|Secondary|Absence of Gastric and/or Duodenal Ulcer up to 12 Weeks After Treatment|The absence of gastric and/or duodenal ulcer up to 12 weeks after treatment|up to 12 weeks|||Participants|||Number
750166|NCT00542789|Secondary|Absence of Gastric and/or Duodenal Ulcer up to 4 Weeks After Treatment|The absence of gastric and/or duodenal ulcer up to 4 weeks after treatment|up to 4 weeks|||Participants|||Number
750167|NCT00542789|Primary|Absence of Gastric and/or Duodenal Ulcer Throughout the Treatment Period|The absence of gastric and/or duodenal ulcer throughout the treatment period|each visit up to 24 weeks|Two participants were excluded from these sets because they took no investigational drug or had major protocol deviation. As the result, the numbers of participants for gender baseline were 173 in Esomeprazole 20 mg and 168 in Placebo, respectively.||Participants|||Number
750168|NCT00542815|Secondary|The Percent Change in Serum LDL-cholesterol for MCI-196 and Sevelamer|Percent Change from Baseline to Week 52 (LOCF)|52 weeks (Baseline-52 weeks)|ITT2 population included all subjects who received enrolment number into MCI-196-E10, took at least 1 dose of study medication in original study and had at least 1 post-enrolment efficacy value after start of study medication in MCI-196-E10. Data collected from start of original studies to end of MCI-196-E10 were analysed for this population.||percentage change of LDL-cholesterol||Standard Deviation|Mean
750169|NCT00542815|Primary|The Change in Serum Phosphorus for MCI-196 and Sevelamer|Change from Baseline to Week 52 (LOCF)|52 weeks (Baseline-52 weeks)|ITT2 population included all subjects who received enrolment number into MCI-196-E10, took at least 1 dose of study medication in original study and had at least 1 post-enrolment efficacy value after start of study medication in MCI-196-E10. Data collected from start of original studies to end of MCI-196-E10 were analysed for this population.||mg / dL||Standard Deviation|Mean
750170|NCT00542828|Secondary|Number of Participants With a Marrow Remission|This is a measure of bone marrow complete remission for participants who experience a remission. Bone marrow complete remission is defined as a bone marrow assessment of <=5% myeloblasts and decrease by >=50% over pretreatment.|36 months|This secondary outcome measure was not formally analyzed or assessed due to the small sample size and early study termination (i.e., no study participants reached the 36-month time point).|||||
750171|NCT00542828|Secondary|Number of Participants With a Cytogenetic Response|This is a measure of cytogenic response for participants whose best response to therapy is a either a complete or partial cytogenetic response. A complete cytogenetic response is defined as the disappearance of the chromosomal abnormality without appearance of new ones. A partial cytogenetic response is defined as at least 50% reduction of the chromosomal abnormality.|36 months|This secondary outcome measure was not formally analyzed or assessed due to the small sample size and early study termination (i.e., no study participants reached the 36-month time point).|||||
750172|NCT00542828|Secondary|Number of Participants With Transformation to Acute Myeloid Leukemia|This is a measure of transformation to acute myeloid leukemia only for participants who have bone marrow assessments. Transformation to acute myeloid leukemia is defined as the earliest date a participant experiences bone marrow blasts of >=20% after the start of treatment.|36 months|This secondary outcome measure was not formally analyzed or assessed due to the small sample size and early study termination (i.e., no study participants reached the 36-month time point).|||||
750173|NCT00542828|Secondary|Number of Participants With Progression-free Survival|This is a measure of a progression-free survival which is defined as the time from the participant’s first dose to the date of disease progression, lost to follow-up or death due to any cause, whichever occurs first.|36 months|This secondary outcome measure was not formally analyzed or assessed due to the small sample size and early study termination (i.e., no study participants reached the 36-month time point).|||||
750174|NCT00542828|Secondary|Number of Participants With a Relapse Following Overall Remission|This is a measure of relapse following an overall remission only for participants who experienced either a complete or partial remission. Relapse following an overall remission is defined as a participant who meets any of the following criteria: a return to pretreatment bone marrow blast percentage; decrease of >=50% from maximum remission levels in neutrophils or platelets; reduction in hemoglobin concentration by >=1.5 g/dL from maximum remission levels; or transfusion dependence.|36 months|Secondary outcome measure was not formally analyzed or assessed due to early study termination and small sample size (i.e., no study participants reached the 36-month time point)|||||
750175|NCT00542828|Secondary|Number of Participants With a Relapse Following HI|This is a measure of relapse following HI, which is defined as a participant who experiences at least one of the following: >=50% decrease from maximum response levels in granulocytes or platelets; >=1.5 g/dL reduction in hemoglobin; or transfusion dependence.|36 months|This secondary outcome measure was not formally analyzed or assessed due to the small sample size and early study termination (i.e., no study participants reached the 36-month time point).|||||
750176|NCT00542828|Secondary|Number of Participants With Duration of Transfusion Independence|This is a measure of the duration of transfusion independence only for those participants who achieved transfusion independence. Duration of transfusion independence is defined as the longest period of time during which a participant requires no transfusions.|36 months|This secondary outcome measure was not formally analyzed or assessed due to the small sample size and early study termination (i.e., no study participants reached the 36-month time point).|||||
750177|NCT00542828|Secondary|Number of Participants Who Achieved Transfusion Independence|This is a measure of transfusion independence, which is defined as a participant with no transfusions for a period of 8 consecutive calendar weeks after first dose. Transfusion independence was to be calculated only for those participants who had documented transfusions during the 8 weeks prior to enrollment.|36 months|This secondary outcome measure was not formally analyzed or assessed due to the small sample size and early study termination (i.e., no study participants reached the 36-month time point).|||||
750476|NCT00553098|Secondary|Immune Reconstitution by 1 Year Post Transplant|Number of patients with normal range CD3 at 1 year post transplant|1 year|Excludes 16 patients: 13 patients who did not achieve 1 year time point (9 expired, 4 went to second transplant) and 3 patients for whom no data was sent at 1 year from external site||Participants|||Count of Participants
750178|NCT00542828|Secondary|Duration of Disease Remission|This is a measure of the duration of overall disease remission only for those participants who achieved an overall remission. Duration of overall remission is defined as the time from first documentation of overall remission to the date of first documentation of disease relapse or death due to any cause, whichever occurs first.|36 months|This secondary outcome measure was not formally analyzed or assessed due to the small sample size and early study termination (i.e., no study participants reached the 36-month time point).|||||
750179|NCT00542828|Secondary|Number of Participants Who Achieved Disease Remission|Disease remission is defined as a participant whose best response to therapy was a complete remission or partial remission. A complete remission is defined as: bone marrow <=5% myeloblasts with normal maturation of all cell lines; persistent dysplasia noted; and peripheral blood hemoglobin >=11 g/dL, platelets >=100 x 10^9/L, neutrophils >=1.0 x 10^9/L, and blasts 0%. Partial remission is defined as: all complete remission criteria if abnormal before treatment, except bone marrow blasts decreased by >=50% over pretreatment, but still >5%; and cellularity and morphology not relevant.|36 months|This secondary outcome measure was not formally analyzed or assessed due to the small sample size and early study termination (i.e., no study participants reached the 36-month time point).|||||
750180|NCT00542828|Secondary|Number of Participants With Duration of HI|This is a measure of the duration of HI for those participants who achieved HI. Duration of HI is defined as the time from confirmation of HI response to the date of first documentation of HI relapse or death due to any cause, whichever occurs first.|36 months|This secondary outcome measure was not formally analyzed or assessed due to the small sample size and early study termination (i.e., no study participants reached the 36-month time point).|||||
750181|NCT00542828|Primary|Number of Participants Who Achieved Hematologic Improvement (HI)|This is a measure of HI in the erythroid, platelet, and neutrophil lineages. Note that HI was observed in the erythroid lineage only, which is defined as a participant who had a >=1.5 g/dL increase in hemoglobin from baseline (pretreatment value must have been <11 g/dL) and who had a relevant reduction of units of red blood cell (RBC) transfusions by an absolute number of >=4 RBC transfusions over 8 weeks as compared with the pretreatment transfusion number in the previous 8 weeks. These criteria were taken from the 2006 International Working Group criteria.|12 months|Number of participants analyzed includes those who received treatment with Thymoglobulin and completed follow-up efficacy assessments. However, no formal efficacy analysis was conducted due to the small sample size and early study termination.||participants|||Number
750182|NCT00549302|Secondary|Probability of No Pulmonary Arterial Hypertension (PAH) Deterioration at Weeks 16, 28, 40 and up to 52|World Health Organization Functional Classification Assessment (WHO FC) is a method of classifying disease severity in PAH. The classes are: Class I: pulmonary hypertension (PH) but without resulting limitation of physical activity, Class II: PH resulting in slight limitation of physical activity, Class III: PH resulting in marked limitation of physical activity, Class IV: PH with inability to carry out any physical activity without symptoms. Deterioration of WHO FC is defined as moving to a higher WHO FC within one visit. Results are presented as Kaplan-Meier estimates (% probability) of remaining free from WHO FC deterioration after a given time.|Baseline and Weeks 16, 28, 40 and 52|Safety Population: all randomized participants who received at least 1 dose of study drug.||probability (%) no PAH deterioration||95% Confidence Interval|Number
750183|NCT00549302|Secondary|Borg Dyspnea Assessment at Baseline and Weeks 16, 28, 40 and 52|Borg dyspnea score is a participant rated measure of their greatest degree of shortness of breath during exertion (6-minute walk test). Score ranged from 0 (nothing at all) to 10 (very, very severe [maximal]).|Baseline and Weeks 16, 28, 40 and 52|All randomized participants who received at least 1 dose of study drug and who completed the Borg Dyspnea Assessment; LOCF||units on a scale||Standard Deviation|Mean
750184|NCT00549302|Secondary|6-Minute Walk Distance (6MWD) at Baseline and Weeks 16, 28, 40 and 52|6MWD measured the distance a participant was able to walk unassisted in 6 minutes.|Baseline and Weeks 16, 28, 40 and 52|All randomized participants who received at least 1 dose of study drug and who completed 6MWD test; Last Observation Carried Forward (LOCF)||meters (m)||Standard Deviation|Mean
750185|NCT00549302|Primary|Number of Participants With Adverse Events (AEs)|A summary of serious and all other non-serious AEs, which include adverse events reported for laboratory tests and vital signs, is located in the Reported Adverse Event module.|Baseline (Double-Blind Period) up to Week 243 (End of Open-Label Period)|Safety Population: all randomized participants who received at least 1 dose of study drug.||participants|||Number
750186|NCT00549328|Secondary|Characterization of Participant Populations by Identification of Intra-tumoral Biomarkers|Biomarkers are proteins that respond in a unique way to treatment with the study drug; however, levels of proteins were not collected for this measurement. No formal efficacy analyses were performed due to early termination of the study.|Baseline through End of Study (up to 2 years)|All Treated Population|||||
750187|NCT00549328|Secondary|Levels of Circulating Biomarkers in Plasma|Biomarkers are proteins that respond in a unique way to treatment with the study drug; however, levels of proteins were not collected for this measurement. No formal efficacy analyses were performed due to early termination of the study.|Baseline through End of Study (up to 2 years)|All Treated Population|||||
750188|NCT00549328|Secondary|Overall Survival|Overall survival is defined as the time from the start of treatment until death due to any cause. No formal efficacy analyses were performed due to early termination of the study.|Baseline through End of Study (up to 2 years)|All Treated Population|||||
750189|NCT00549328|Secondary|Progression-Free Survival|Progression-free survival is defined as the interval between the start of treatment and the earliest date of disease progression or death due to any cause, whichever occurs first. No formal efficacy analyses were performed due to early termination of the study.|Baseline through End of Study (up to 2 years)|All Treated Population|||||
750190|NCT00549328|Secondary|Number of Participants Who Had a Complete or Partial Response, or Stable Disease|Disease control was measured. Stable disease (SD) is defined as neither partial response (at least a 30% decrease in the sum of the longest diameters of target lesions taken as a reference to baseline sum of the longest diameters, confirmed at 4 weeks) nor progressive disease (PD; a 20% increase in the sum of the longest diameters of target lesions, taken as a reference the smallest sum of the longest diameter recorded since the treatment started or the appearance of one or more new lesions. No formal efficacy analyses were performed due to early termination of the study.|Baseline through End of Study (up to 2 years)|All Treated Population|||||
750191|NCT00549328|Primary|Percentage of Participants Who Achieved Either a Confirmed Complete Response or Partial Response Per RECIST Criteria|The best overall response using Response Evaluation Criteria In Solid Tumors (RESIST) was measured. Complete response is defined as the disappearance of all known lesion(s), confirmed at 4 weeks, and partial response is defined as at least a 30% decrease in the sum of the longest diameters of target lesions taken as a reference to baseline sum of the longest diameters, confirmed at 4 weeks. No formal efficacy analyses were performed due to early termination of the study.|Baseline through End of Study (up to 2 years)|All Treated Population: all participants who met inclusion criteria and willingly consented to participate in the study|||||
750192|NCT00549393|Other Pre-specified|Bacteremia|per protocol analysis of incidence of bacteremia comparing those in treatment and control groups|duration of ICU stay, median 3 days|Includes per protocol population of 1547 of 2422 in the treatment arm||events per 1000 at-risk days||95% Confidence Interval|Number
750193|NCT00549393|Secondary|Central Line Associated-bloodstream Infection (CLABSI)|Comparing incidence of central line-associated bloodstream infections between treatment and control groups|participants were followed for the duration of ICU stay, median stay 3 days|||events per 1000 at-risk days||95% Confidence Interval|Number
750194|NCT00549393|Primary|Bacteremia|incidence of bacteremia comparing those in treatment and control groups|participants were followed for the duration of ICU stay, median stay 3 days|Intent to treat population||events per 1000 at-risk days||95% Confidence Interval|Number
750195|NCT00549445|Primary|Levels of PGP From Sputum Samples of COPD Patients Being Treated With Azithromycin.|"Nasopharyngeal swabs were obtained to determine if there is a reduction in PGP levels (including both PGP & Neutrophil-PGP) after chronic treatment with azithromycin.
Unblinding of the parent trial revealed that there were 18 sputum samples from 13 placebo-treated participants and 14 sputum samples from 8 azithromycin-treated participants collected at months 1 through 12 of treatment (with sputum samples not being available, this greatly reduced the sample size)."|Baseline to 12 months|Levels of PGP from sputum samples are compared between subjects on the macrolide antibiotic, azithromycin, and subjects on placebo and correlated with neutrophil counts and protease activity in sputum.||ng/mL||Full Range|Mean
750196|NCT00549549|Secondary|Number of Participants With Moderate or Severe Central Nervous System (CNS) Adverse Events|The pre-specfied CNS AEs were headache, nausea, dizziness, vertigo, vomiting and somnolence.|Baseline to Day 14/Early Termination|ITT||Participants|||Number
750197|NCT00549549|Secondary|Number of Participants With Pre-specified Gastrointestinal (GI) Adverse Events|The gastrointestinal tolerability was measured by incidence of moderate or severe GI adverse events (nausea, abdominal pain and dyspepsia)|Baseline to Day 14/Early Termination|ITT||Participants|||Number
750198|NCT00549549|Secondary|Participants Global Evaluation of Study Medication Score|"The participant rated the study medication that they received during the study by completing the following question:
How would you rate the study medication you received for pain? 4=Excellent, 3=Good, 2=Fair, 1=Poor"|Day 9|ITT||Scores on a scale||Standard Deviation|Mean
750199|NCT00549549|Secondary|Number of Participants With Withdrawal From Treatment Due to Lack of Efficacy|Withdrawal due to lack of efficacy was assessed from Days 1 to 8|Day 1 to Day 8|ITT||Participants|||Number
750200|NCT00549549|Secondary|Percentage Change From Baseline in the Patient’s Assessment of Pain Intensity for the Average Pain Intensity on Days 2-4, Days 2-8 and Days 2-13|The participant's assessment of pain was assessed by completion of the following 5 point scale: My change in pain has been: None (0), Mild (1), Moderate, (2), Severe (3), and Extreme (4). Average change over days was calculated by taking the change from Baseline to the average Pain Intensity score over the days for each patient.|Baseline to Day 13|ITT, LOCF||Percentage change||Standard Deviation|Mean
750201|NCT00549549|Secondary|Participant's Assessment of Pain Intensity for the Average Pain Intensity at Baseline|The participant's assessment of pain was assessed by completion of the following 5 point scale: My pain has been: None (0), Mild (1), Moderate, (2), Severe (3), and Extreme (4).|Baseline|ITT, LOCF||Units on a scale||Standard Deviation|Mean
750202|NCT00549549|Secondary|Number of Participants With ≥30% and ≥50% Reduction From Baseline to Day 2 in Patient’s Assessment of Pain Intensity|The Patient’s assessment of pain was assessed by completion of the following 5 point scale: My pain over the past 24 hours has been: None (0), Mild (1), Moderate, (2), Severe (3), and Extreme (4).|Baseline, Day 2|ITT and LOCF||Participants|||Number
750203|NCT00549549|Secondary|Change From Baseline in Time Weighted Average of Patient’s Assessment of Pain Intensity Over 8, 12, and 24 Hours|Time weighted average over 8 (TWA-8), 12 (TWA-12) and 24 (TWA-24) hours post first dose of study medication on Day 1. Positive TWA values represent a reduction in pain intensity|Baseline, 8, 12, and 24 hours post first dose|ITT and LOCF||Scores on a scale||Standard Deviation|Mean
750204|NCT00549549|Secondary|Change From Baseline in Patient’s Assessment of Pain Intensity on Day 1|The patient’s assessment of pain was assessed by completion of the following 5 point scale: my pain at this time is none (0), mild (1), moderate, (2), severe (3), and extreme (4).|Baseline, 2, 4, 8, 12 hours postdose Day 1, Day 2 (24 hours and 32 hours post first dose)|Intent to treat (defined to be all subjects who were randomized, took at least 1 dose of study medication and had at least one post baseline evaluation, ITT) and LOCF||Scores on a scale||Standard Deviation|Mean
750205|NCT00549549|Secondary|Change From Baseline in Patient’s Assessment of Pain Intensity|The Patient’s assessment of pain for the prior 24 hours was assessed by completion of the following 5 point scale: My pain over the past 24 hours has been: None (0), Mild (1), Moderate, (2), Severe (3), and Extreme (4).|Baseline, Day 2 to Day 13|Intent to treat (defined to be all subjects who were randomized, took at least 1 dose of study medication and had at least one post baseline evaluation, ITT) and LOCF||Scores on a scale||Standard Deviation|Mean
750206|NCT00549549|Secondary|Number of Participants With Warmth Present According to Physician’s Assessment of the Index Joint on Day 5, Day 9, and Day 14|Warmth was assessed by the physician as present or absent.|Baseline, Day 5, Day 9 and Day 14|Intent to treat (defined to be all subjects who were randomized, took at least 1 dose of study medication and had at least one post baseline evaluation, ITT) and LOCF||Participants|||Number
750207|NCT00549549|Secondary|Number of Participants With Redness Present According to Physician’s Assessment of the Index Joint on Day 5, Day 9, and Day 14/Early Termination|Redness was assessed by the physician as present or absent.|Baseline, Day 5, Day 9 and Day 14/Early Termination|Intent to treat (defined to be all subjects who were randomized, took at least 1 dose of study medication and had at least one post baseline evaluation, ITT) and LOCF||Participants|||Number
750208|NCT00549549|Secondary|Change From Baseline in Physician’s Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Swelling|Swelling was assessed using a 4 point scale with the following ratings: none (0), palpable (1), visible (2), and bulging beyond joint margins (3)|Baseline, Days 5, 9 and 14/Early Termination|Intent to treat (defined to be all subjects who were randomized, took at least 1 dose of study medication and had at least one post baseline evaluation, ITT) and LOCF||Scores on a scale||Standard Deviation|Mean
750209|NCT00549549|Secondary|Change From Baseline in Physician’s Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Tenderness|Tenderness was assessed on the basis of palpation or passive motion using a 4 point scale with the following ratings: the patient had no tenderness (0), the patient complained of pain (1), the patient complained of pain and winced (2) and the patient complained of pain, winced, and withdrew (3).|Baseline, Day 5, Day 9, and Day 14/Early Termination|Intent to treat (defined to be all subjects who were randomized, took at least 1 dose of study medication and had at least one post baseline evaluation, ITT) and LOCF||Scores on a scale||Standard Deviation|Mean
750210|NCT00549549|Primary|Change From Baseline to Day 2 in Patient's Assessment of Pain Intensity|The Patient’s Pain Intensity in the Index Joint for the prior 24 hours was assessed by completion of the following 5 point scale: My pain over the past 24 hours has been: None (0), Mild (1), Moderate (2), Severe (3), or Extreme (4).|Baseline and Day 2|Intent to treat (ITT): defined to be all subjects who were randomized, took at least 1 dose of study medication and had at least one post baseline evaluation; and Last Observation Carried Forward (LOCF)||Scores on a scale||Standard Deviation|Mean
750211|NCT00549562|Secondary|The Vineland Adaptive Behavior Scales (VABS) - Maladaptive Behavior Domain|The VABS Maladaptive Behavior Domain measures undesirable behaviors that may interfere with an individual's adaptive functioning. The Maladaptive Domain consists two parts. Part I contains 27 minor maladaptive items and Part II contains 9 serious maladaptive behaviors. Each item is scored from 0 (never or seldom engages in the activity) to 2(usually or habitually engages in the activity). Part 1 yields a score of 0 to 54. Part II yields a score of 0 to 18. Both parts are combined to make a Total Score of 0 to 72. High scores of maladaptive behaviors reflect more negative behavior.|Week 8|||units on a scale||Standard Deviation|Mean
750212|NCT00549562|Secondary|The Social Responsiveness Scale|The Social Responsiveness Scale (SRS) is a 65-item parent completed scale that assesses social awareness, social cognition, social communication, social motivation and autistic mannerisms. Each item is scored from 1 (not true) to 3 (almost always true). Interpretation in this study is based on a total score that is proportional to the level of impairment in reciprocal social behavior. Scores within 0-53 are within normal limits. Scores within 54-86 indicate mild to moderate impairment. Scores above 87 indicate severe impairment.|Week 8|||units on a scale||Standard Deviation|Mean
750213|NCT00549562|Secondary|The Children's Yale-Brown Obsessive Compulsive Scale Modified for Pervasive Developmental Disorders|The Children's Yale-Brown Obsessive Compulsive Scale Modified for Pervasive Developmental Disorders (CY-BOCS-PDD) is semi-structured clinician rating scale designed to rate the current severity of repetitive behavior in children and adolescents with PDD. The scale consists of 5 items: Time Spent, Interference, Distress, Resistance and Control. Each item is scored from 0 (None) to 4 (Extreme). The scale yields a Total Score from 0 (least symptomatic) to 20 (most symptomatic). Higher scores indicate greater severity of repetitive behavior.|Week 8|||units on a scale||Standard Deviation|Mean
750214|NCT00549562|Primary|The Aberrant Behavior Checklist|The Aberrant Behavior Checklist (ABC) is a 58-item measure of maladaptive behaviors and is used as a measure of drug effects. Each item is rated from 0 (not at all to 3 (severe). The ABC has 5 subscales:Irritability (15 items) ranging from 0 (not at all) to 45 (severe), Hyperactivity (16 items) ranging from 0 (not at all) to 48 (severe), Social Withdrawal (16 items) ranging from 0 (not at all) to 48 (severe), Stereotypy (7 items) ranging from 0 (not at all) to 21 (severe) and Inappropriate Speech (4 items) ranging from 0 (not at all) to 12 (severe).|Week 8|||units on a scale||Standard Deviation|Mean
750215|NCT00549562|Primary|The Clinical Global Impression-Improvement(CGI-I)|The CGI Global Improvement (CGI-I) is a clinician-rate scale designed to take into account all factors to arrive at an assessment of severity and response to treatment, including parent report, parent-rated measures, teacher-rated measures, and clinician-rated measures. The CGI-I is rated from 1 to 7 (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse) at a single time-point.|Week 8|||units on a scale||Standard Deviation|Mean
750216|NCT00550953|Secondary|Clinically Relevant Abnormalities for Changes in Blood Pressure and Pulse Rate Due to Position Change, Seated Pulse Rate, Laboratory Parameters and ECG|Clinical relevant abnormalities for changes in blood pressure and pulse rate due to position change, seated pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.|First administration of randomised treatment to 24 hours post last dose of randomised treatment|Patients randomised to the double-blind treatment period who took at least one dose either of T40+A5 or T40 during the double-blind treatment period.||participants|||Number
750217|NCT00550953|Secondary|Percentage of Patients With Optimal, Normal or High Normal Blood Pressure at 8 Weeks (0 Percent at Baseline)|"Optimal, normal, high normal blood pressure were defined as follows:
Optimal: Systolic blood pressure (SBP) < 120 mmHg and diastolic blood pressure (DBP) < 80 mmHg
Normal: SBP >= 120 mmHg or DBP >= 80 mmHg and SBP < 130 mmHg and DBP < 85 mmHg
High normal: SBP >= 130 mmHg or DBP >= 85 mmHg and SBP < 140 mmHg and DBP < 90 mmHg"|8 weeks|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.||percentage of participants|||Number
750218|NCT00550953|Secondary|Percentage of Patients Who Achieved an Adequate Response in Seated Trough Systolic Blood Pressure at 8 Weeks (0 Percent at Baseline)|Adequate response defined that seated trough systolic blood pressure was <140 mmHg or decreased from reference baseline by >=20 mmHg at 8 weeks (0 percent at baseline)|8 weeks|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.||percentage of participants|||Number
750477|NCT00553098|Secondary|Overall Survival|Number of patients alive at 1 year|1 year|Excludes 3 patients with graft rejection and second transplant prior to 1 year.||Participants|||Count of Participants
750219|NCT00550953|Secondary|Percentage of Patients Who Achieved an Adequate Response in Seated Trough Diastolic Blood Pressure at 8 Weeks (0 Percent at Baseline)|Adequate response defined that seated trough diastolic blood pressure was <90 mmHg or decreased from reference baseline by >=10 mmHg at 8 weeks|8 weeks|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.||percentage of participants|||Number
750220|NCT00550953|Secondary|Percentage of Patients With Seated Trough Systolic Blood Pressure Less Than 140 mmHg at 8 Weeks (0 Percent at Baseline)|Seated trough systolic blood pressure defined as blood pressure in a sitting position no later than 24 hours after the last intake|8 weeks|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.||percentage of participants|||Number
750221|NCT00550953|Secondary|Percentage of Patients With Seated Trough Diastolic Blood Pressure Less Than 90 mmHg at 8 Weeks (0 Percent at Baseline)|Seated trough diastolic blood pressure defined as blood pressure in a sitting position no later than 24 hours after the last intake|8 weeks|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.||percentage of participants|||Number
750222|NCT00550953|Secondary|Decrease in Seated Systolic Blood Pressure From Baseline to 8 Weeks|The mean of the change value was least square mean which was calculated by analysis of covariance with factor treatment and center, and covariate baseline.|Baseline and 8 weeks|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.||mmHg||Standard Error|Mean
750223|NCT00550953|Primary|Decrease in Seated Diastolic Blood Pressure From Baseline to 8 Weeks|The mean of the change value was least square mean which was calculated by analysis of covariance with factor treatment and center, and covariate baseline.|Baseline and 8 Weeks|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.||mmHg||Standard Error|Mean
750224|NCT00551031|Secondary|Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine.|"Solicited injection site reactions: Pain, Pruritus, Erythema, Swelling, Induration, and Ecchymosis.
Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Chills"|Days 0 through 7 post-vaccination|Safety analysis was on all enrolled and vaccinated subjects with available reaction data, intent to treat population.||Participants|||Number
750225|NCT00551031|Primary|Percentage of Participants Who Achieved Seroprotection Before and Post-vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine.|Seroprotection was defined as a Hemagglutination inhibition (HAI) titer ≥ 1:40|Day 0 and Day 28 post-vaccination|Serum antibody titers were assessed in the per protocol population.||Percentage of Participants|||Number
750226|NCT00551031|Primary|Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine|Seroconversion defined as either a pre-vaccination hemagglutination inhibition (HAI) titer < 1:10 and a post vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum four fold increase at one month post-vaccination.|Day 28 post-vaccination|Serum antibody titers were assessed in the per protocol population.||Percentage of Participants|||Number
750227|NCT00551031|Primary|Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine.|Serum antibody titers for the Influenza vaccine serogroups A/H1N1, A/H3N2, and B were assessed by hemagglutinin inhibition (HAI) assay.|Day 0 and Day 28 post vaccination|Serum antibody titers GMTs were assessed in the per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
750228|NCT00551070|Secondary|Overall Survival||Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years|Eligible and Treated Patients||Months||95% Confidence Interval|Median
750229|NCT00551070|Primary|Maximum Concentration (Cmax) for AZD6244, 100 mg Administered Orally Twice Daily.||Pre-dose, and 1, 3, and 6 hours after administration of drug on Day 7 after the start of AZD6244 treatment|Eligible and Treated Patients with at least one post-dose pharmacokinetic time point available||ng/mL||Inter-Quartile Range|Median
750230|NCT00551070|Primary|Area Under the Curve (AUC) for AZD6244, 100 mg Administered Orally Twice Daily.||Pre-dose, and 1, 3, and 6 hours after administration of drug on Day 7 after the start of AZD6244 treatment|Eligible and Treated Patients with all pharmacokinetic time points available||ng x hr/mL||Inter-Quartile Range|Median
750231|NCT00551070|Primary|Adverse Events (Grade 3 or Higher) During First Cycle of Treatment||Cycle 1|Eligible and treated patients.||percentage of patients||95% Confidence Interval|Number
750232|NCT00551070|Secondary|Number of Courses Received||Every cycle|Eligible and Treated Patients. Two patients still on study and have received 68 and 79 cycles of treatment.||courses||Inter-Quartile Range|Median
750233|NCT00551070|Secondary|Progression-free Survival||Every other cycle|Eligible and Treated Patients||months||95% Confidence Interval|Median
750234|NCT00551070|Primary|Tumor Response|Complete and Partial Tumor Response by (Response Evaluation Criteria in Solid Tumors) RECIST 1.0|Every other cycle|Eligible and treated patients||percentage of patients||90% Confidence Interval|Number
750235|NCT00551135|Secondary|Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI)|NPSI: a 12-item self-administered questionnaire to assess the characteristics of neuropathic pain on average in the last 24 hours. 5 subscale scores include: burning spontaneous (spont.) pain, pressing spont. pain, paroxysmal pain, evoked pain, and paresthesia or dysesthesia (paresth/dysesth) (range: 0 [no pain] to 10 [worst pain imaginable]); total score calculated from the 5 pain subscores (range: 0 to 0.5), higher scores meaning worse pain.|1, 3, and 6 months (mo) post surgery (PS)|MITT; data from 1 site excluded due to GCP deviations; n=number of subjects who reported surgery-related pain at assessment (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively). Data insufficient for standard deviation calculation at 6 mo PS.||scores on a scale||Standard Deviation|Mean
750236|NCT00551135|Secondary|Chronic Postoperative Pain: Pain Severity Index Score and Pain Interference Index Score on the Modified Brief Pain Inventory–Short Form (mBPI-sf)|m-BPI-sf: a self-administered 11-point Likert rating scale to rate pain in the past 24 hours. Pain interference index score is mean of 7 individual item scores for interference of pain with functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life); range: 0 (does not interfere) to 10 (completely interferes with functional activities). Pain severity index score is mean of 4 individual item scores for pain severity (pain right now, and worst, least, and average pain); range: 0 (no pain) to 10 (worst imaginable pain).|1, 3, and 6 months (mo) post surgery (PS)|MITT; data from 1 site excluded due to GCP deviations; n=number of subjects who reported surgery-related pain at assessment (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively). Data insufficient for standard deviation calculation at 6 mo PS.||scores on a scale||Standard Deviation|Mean
750237|NCT00551135|Secondary|Participants With Chronic Postoperative Pain|"Number of participants who reported surgery-related pain at assessment (by answering 'yes' to a single question: In the last 24 hours, have you had pain in the area affected by your surgery?)"|1, 3, and 6 months (mo) post surgery (PS)|MITT; data from 1 site excluded due to GCP deviations; n=number of subjects with analyzable data at observation (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively).||participants|||Number
750238|NCT00551135|Secondary|Baseline and Change From Baseline in Short Form Acute Health Survey 12-Item Version (SF-12v2) Physical Component Summary Score (PCSS) and Mental Component Summary Score (MCSS)|PCSS and MCSS are component summary scores from the self-administered SF-12v2 acute health quality of life, norm-based survey. PCSS range: 4.95 to 76.13; MCSS range: -0.79 to 79.69; lowest scores mean very much below and highest scores mean very much above the general population average.|Baseline and End of Treatment (EOT [Day 7 post surgery or Early Termination])|MITT; data from 1 site excluded due to GCP deviations.||scores on a scale||Standard Error|Least Squares Mean
750239|NCT00551135|Secondary|Relationship Between Baseline and Postoperative Pain Catastrophizing Scale (PCS) Score and Severity of Acute Pain and to Response to Therapy|The PCS is a self-administered questionnaire with 13 items, each scored from 0 (not at all) to 4 (all the time) for extent to which participant catastrophizes postoperative pain. Total score is sum of scores for all items (range: 0 to 52); higher scores mean a greater extent of pain catastrophizing.|Baseline and Days 1 and 7 post surgery (PS)|MITT; data from 1 site excluded due to GCP deviations. Data not analyzed as planned.||scores on a scale||Standard Error|Least Squares Mean
750240|NCT00551135|Secondary|Change From Baseline in Pain Catastrophizing Scale (PCS) Total Score and Subscales|The PCS is a self-administered questionnaire with 13 items, each scored from 0 (not at all) to 4 (all the time) for extent to which participant catastrophizes postoperative pain. Total score is sum of scores for all questions (range: 0 to 52); Subscale scores: Rumination (sum of scores for 4 items; range: 0 to 16); Magnification (sum of scores for 3 items; range: 0 to 12); and Helplessness (sum of scores for 6 items; range: 0 to 24); higher scores mean a greater extent of pain catastrophizing.|3 hours (h) post surgery (PS) and End of Treatment (EOT [Day 7 PS or Early Termination])|MITT; data from 1 site excluded due to GCP deviations; n=number of subjects with analyzable data at observation (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively).||scores on a scale||Standard Error|Least Squares Mean
750241|NCT00551135|Secondary|Baseline and Change From Baseline in EuroQol (EQ-5D) Health State Profile Score|EQ-5D is a self-administered questionnaire to assess health-related quality of life in 5 domains (mobility, self care, usual activities, pain or discomfort, and anxiety or depression). Scores from the 5 domains are used to calculate a single index value: the Health State Profile Score; range: 0.0 (death) to 1.0 (perfect health), higher scores indicating better health state.|Baseline and End of Treatment (EOT [Day 7 post surgery or Early Termination])|MITT; data from 1 site excluded due to GCP deviations.||scores on scales||Standard Error|Least Squares Mean
750242|NCT00551135|Secondary|Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score|Anxiety VAS is a single-item self-administered continuous measure of anxiety using a 100-millimeter (mm) line on which the subject is asked to place a mark indicating the intensity of current anxiety. The score is the distance in mm from the left-most point on the line to the subject’s mark; range: 0 (Not at all anxious) at the left-most point to 100 (Extremely anxious) at the right-most point. Performed prior to blood draws.|Baseline; 2 hours (h) before surgery (BS); 1, 2, and 3 h PS; Days 2, 3, 4, 5, 6, 7, 8, and 9 PS|MITT; data from 1 site excluded due to GCP deviations; n=number of subjects with analyzable data at observation (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively).||scores on a scale||Standard Error|Least Squares Mean
750243|NCT00551135|Secondary|Participants With Physician Contacts Post-discharge|"Number of participants who answered yes to the Post-Surgery Contact question: From the time you were discharged from the hospital, did you have to contact any type of physician because of pain, difficulty getting up and walking about, or difficulty with passing urine?"|24 and 72 hours (h) post surgery (PS)|MITT; data from 1 site excluded due to GCP deviations||participants|||Number
750244|NCT00551135|Secondary|Participants With Wound Healing Complications|Investigator-assigned mutually exclusive categories of: 1) no surgical wound complication, 2) superficial incisional surgical site infection, 3) deep incisional surgical site infection, 4) organ or space surgical site infection, or 5) non-infectious wound healing complication.|Day 7 post surgery (PS) and up to 30 days PS|Operated subjects within the safety population. Safety population=all randomized subjects administered at least 1 dose of study drug and for whom at least 1 post-baseline safety evaluation was obtained.||participants|||Number
750245|NCT00551135|Secondary|Subject Global Evaluation of Study Medication (GESM)|GESM is a self-administered overall impression (global evaluation) of study medication received for pain; 4 categories: poor, fair, good, and excellent.|24 hours (h) post surgery (PS) and End of Treatment (EOT [Day 7 PS or Early Termination])|MITT; data from 1 site excluded due to GCP deviations||participants|||Number
750246|NCT00551135|Secondary|Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS)|OR-SDS: a self-administered assessment of 10 common opioid-related side effects (symptoms). A CME is a severe or very severe symptom (or moderate or greater severity symptom of confusion). For individual symptom categories, the number of subjects who experienced at least one CME. Concentrate (concentr).|3, 24, and 72 hours (h) post surgery (PS), and End of Treatment (EOT [Day 7 PS or Early Termination])|MITT; data from 1 site excluded due to GCP deviations.||participants|||Number
750247|NCT00551135|Secondary|Total Clinically Meaningful Event (CME) Score and Cumulative Total Distinct CME Score Using the Opioid-Related Symptom Distress Scale (OR-SDS)|OR-SDS: a self-administered assessment of 10 common opioid-related side effects (symptoms). A CME is a severe or very severe symptom (or moderate or greater severity symptom of confusion). The Total Distinct CME score is the sum of CMEs across symptoms (range: 0 [none] to 10 [10 CMEs]); the Cumulative Total Distinct (CT Distinct) CME score is the sum of Total Distinct CME scores at observation and prior observations. The Total CME score is the same as the Total Distinct CME score except that only 1 CME is counted if both nausea and vomiting (or retching) occur (range: 0 [none] to 9 [9 CMEs]).|3, 24, and 72 hours (h) Post-Surgery (PS), and End of Treatment (EOT [Day 7 PS or Early Termination])|MITT; data from 1 site excluded due to GCP deviations; n=number of subjects with analyzable data at observation (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively).||scores on a scale||Standard Error|Least Squares Mean
750248|NCT00551135|Secondary|Amount of Non-opioid Rescue Medication (Naproxen and Antiemetic Medications) Used During the Study|Total cumulative dose of naproxen calculated in milligrams (mg) from the end of surgery up to and including Day 7 after surgery.|End of Surgery through Day 7 post surgery|MITT; data from 1 site excluded due to GCP deviations. Amount of antiemetic rescue medications not analyzed as planned.||mg||Standard Error|Least Squares Mean
750249|NCT00551135|Secondary|Total Cumulative Dose of Opioids and Tramadol Used During and After Surgery|Total cumulative dose of opioids and tramadol administered by any route during surgery and postoperatively. Dose of tramadol calculated as milligrams (mg) of oral morphine equivalent.|24, 48, and 72 hours (h) post surgery (PS), and Days 4, 5, 6, and 7 PS|MITT; data from 1 site excluded due to GCP deviations; n=number of subjects with analyzable data at observation (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively). During surgery data not analyzed as planned.||mg||Standard Error|Least Squares Mean
750250|NCT00551135|Secondary|Daily Sleep Interference Rating Scale (DSIRS) Score|DSIRS: self-administered 11-point Likert scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep [unable to sleep due to pain]) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Performed daily on awakening, prior to taking study medication.|Days 2, 3, 4, 5, 6, 7, 8, 9, and 10 post surgery (PS)|MITT; data from 1 site excluded due to GCP deviations; n=number of subjects with analyzable data at observation (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively).||scores on a scale||Standard Error|Least Squares Mean
750251|NCT00551135|Secondary|Time From End of Surgery to Discharge From Post-Anesthesia Care Unit (PACU)||Day 1|MITT; data from 1 site excluded due to GCP deviations. Data not analyzed as planned.||hours||Standard Error|Least Squares Mean
750252|NCT00551135|Secondary|Time From End of Surgery to Reach a Total Score of at Least 9 on the Post-Anesthetic Discharge Scoring System (PADS)|PADS is a 5-item scale (individual item range: 0-2; higher scores indicating better readiness for hospital discharge). Total score range: 0-10, with 9 or higher indicating eligibility for discharge. End of surgery is time of transfer to post-anesthesia care unit (PACU). Subjects who did not reach a score of 9 on PADS were censored at the date and time of discharge.|Day 1|MITT; data from 1 site excluded due to GCP deviations. No descriptive statistics were generated.||hours||Standard Error|Least Squares Mean
750253|NCT00551135|Secondary|Time From End of Surgery to First Rescue Medication|Rescue medication includes both naproxen and narcotic medication (including tramadol and opioid analgesics). For subjects without use of rescue medication, the time-to-event variable is censored at the Beginning of Taper Visit (Day 7 PS) or at time of withdrawal.|Day 1 through Day 7 post surgery|MITT; data from 1 site excluded due to GCP deviations. No descriptive statistics were generated.||hours||Standard Error|Least Squares Mean
750254|NCT00551135|Secondary|Numeric Rating Scale (NRS): Average Pain|NRS: a self-administered questionnaire to rate pain. A single item asks participant to rate pain on average in the last 24 hours; range: 0 (no pain) to 10 (worst pain).|2 hours (h) before surgery (BS); 1, 2, and 3 h post surgery (PS); Days 1, 2, 3, 4, 5, 6, and 7 PS|MITT; data from 1 site excluded due to GCP deviations; n=number of subjects with analyzable data at observation (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively).||scores on scale||Standard Error|Least Squares Mean
750255|NCT00551135|Secondary|Numeric Rating Scale (NRS): Current Pain at Rest - Area Under the Curve (AUC)|NRS: a self-administered questionnaire to rate pain. AUC for a single item asking participant to rate current pain at rest (preceding pain with movement); range: 0 (no pain) to 10 (worst pain).|1 through 48 hours post surgery (PS)|MITT; data from 1 site excluded due to GCP deviations.||score on scale||Standard Error|Least Squares Mean
750256|NCT00551135|Secondary|Numerical Rating Scale (NRS): Current Pain at Rest|NRS: a self-administered questionnaire to rate pain. A single item asks participant to rate current pain at rest (preceding pain with movement); range: 0 (no pain) to 10 (worst pain).|2 hours (h) before surgery (BS); 1, 2, and 3 h post surgery (PS); Days 2, 3, 4, 5, 6, 7, 8, 9, and 10 PS|MITT; data from 1 site excluded due to GCP deviations; n=number of subjects with analyzable data at observation (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively).||scores on scale||Standard Error|Least Squares Mean
750257|NCT00551135|Secondary|Numeric Rating Scale (NRS): Current Pain With Movement - Area Under the Curve (AUC) for Sitting, Walking, and Coughing|NRS: a self-administered questionnaire to rate pain. AUC from 1 h PS through 48 h PS for ratings of pain caused by movements of sitting, walking, and coughing; Range: 0 (no pain) to 10 (worst pain).|1 hour through 48 hours post surgery|MITT; 1 site excluded for GCP deviations; n=subjects with analyzable data at observation (pregabalin 50, 150, and 300 mg, and placebo, respectively).||scores on scale||Standard Error|Least Squares Mean
750258|NCT00551135|Secondary|Numeric Rating Scale (NRS): Current Pain With Movement - Coughing|NRS: a self-administered questionnaire to rate pain. A single item asks to rate pain with movement caused by coughing (coughing two times while sitting); range: 0 (no pain) to 10 (worst pain)|Baseline; 2 hours (h) before surgery (BS); 1, 2, and 3 h post surgery (PS); Days 2, 3, 4, 5, 6, and 7 PS; and End of Treatment (EOT [Day 7 PS or Early Termination])|MITT; data from 1 site excluded due to GCP deviations; n=number of subjects with analyzable data at observation (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively).||scores on scale||Standard Error|Least Squares Mean
750509|NCT00553332|Secondary|RAS/RAF/MEK/ERK Signaling Pathway Activation||At baseline|Data was not collected and analyzed|||||
750510|NCT00553332|Secondary|Overall Survival||Up to 12 months|Kaplan-Meier||months||95% Confidence Interval|Median
750259|NCT00551135|Secondary|Numeric Rating Scale (NRS): Current Pain With Movement - Walking|NRS: a self-administered questionnaire to rate pain. A single item asks to rate pain with movement caused by walking (rising from sitting position and walking approximately 5 meters or 16 feet at a moderate pace); range: 0 (no pain) to 10 (worst pain).|Baseline; 2 hours (h) before surgery (BS); 1, 2, and 3 h post surgery (PS); Days 2, 3, 4, 5, 6, and 7 PS; and End of Treatment (EOT [Day 7 PS or Early Termination])|MITT; data from 1 site excluded due to GCP deviations; n=number of subjects with analyzable data at observation (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively).||scores on scale||Standard Error|Least Squares Mean
750260|NCT00551135|Secondary|Numeric Rating Scale (NRS): Current Pain With Movement - Sitting|NRS: a self-administered questionnaire to rate pain. A single item asks to rate pain with movement caused by sitting (sitting in a standardized fashion after being in a fully supine position); range: 0 (no pain) to 10 (worst pain).|Baseline; 2 hours (h) before surgery (BS); 1, 2, and 3 h post surgery (PS); Days 2, 3, 4, 5, 6, and 7 PS; and End of Treatment (EOT [Day 7 PS or Early Termination])|MITT; data from 1 site excluded due to GCP deviations; n=number of subjects with analyzable data at observation (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively).||scores on scale||Standard Error|Least Squares Mean
750261|NCT00551135|Primary|Modified Brief Pain Inventory–Short Form (mBPI-sf): Worst Pain 24 Hours Post Surgery|m-BPI-sf: a self-administered 11-point Likert rating scale to rate pain in the past 24 hours. A single item pertains to worst pain in the past 24 hours: range of 0 (no pain) to 10 (worst imaginable pain).|24 hours post surgery|Modified Intent-to-Treat Population (MITT): all subjects included in intent-to-treat population who took study medication 12 and 2 hours prior to surgery, had no complications during herniorrhaphy, and had the post-surgery primary efficacy measurement. Data from 1 site excluded due to Good Clinical Practices (GCP) deviations.||scores on scale||Standard Error|Least Squares Mean
750262|NCT00551161|Primary|Changes in the Metabolite Ratios of N-acetylaspartate (NAA) to Creatine (Cr), Myo-inositol (mI) to Cr, Choline (Cho) to Cr, NAA to Cho, and NAA to mI, on Cholinesterase Monotherapy vs Combination of Memantine and Cholinesterase Inhibitor|Ratios of myo-inositol (mI), N-acetylaspartate (NAA), total creatine (Cr), and choline (Cho) by single voxel 1H MRS (proton magnetic resonance spectroscopy). Mean (± SD) metabolite levels (normalized to T2-corrected water signal intensity) and metabolite ratios for Alzheimer's disease subjects at baseline (t0), after 24 weeks of ongoing monotherapy with stable-dose cholinesterase inhibitor (t1), and after another 24 weeks of combination therapy with memantine in addition to stable-dose cholinesterase inhibitor (t2). The Wilcoxon signed-rank test was used to examine whether the change between t0 and t1 differed from the change between t1 and t2 [(t2 – t1) – (t1 – t0)].|Baseline, 24 weeks, and 48 weeks|Per protocol||ratio (normalized to T2-corrected water||Standard Deviation|Mean
750263|NCT00551174|Secondary|Relative Percent Change From Baseline in Post-dose Suppression of Serum CTX at 6 Months|Relative percent (%) change from MA17904 baseline of post-dose suppression of serum C-telopeptide crosslinks of type I collagen (CTX) at 6 months- Study MA17904. Percent change=[(measure at time t - measure at baseline)/measure at baseline]*100%, where t= 6 months. The baseline value is used as a reference to calculate the relative change from baseline.|Baseline, 6 months|Per-Protocol population: 3 mg group = 363, 2 mg group = 344. Analysis populations (AP) for Month 6: 3 mg group = 89, 2 mg group: 93.||Percent change||Standard Deviation|Mean
750264|NCT00551174|Secondary|Relative Percent Change From Baseline in Serum C-telopeptide Crosslinks of Type I Collagen (CTX) at Trough at 6, 12, 24 and 36 Months|Relative percent (%) change from baseline of MA17904 and BM16550 (NCT00048074) in serum C-telopeptide crosslinks of type I collagen (CTX) at trough at 6, 12, 24 and 36 months- Study MA17904. Percent change=[(measure at time t - measure at baseline)/measure at baseline]*100%, where t=6, 12, 24 and 36 months. The baseline value is used as a reference to calculate the relative change from baseline.|Baseline, 6, 12, 24 and 36 months (i.e., 2.5, 3, 4 and 5 years after initiation of BM16550)|Per-Protocol population: 3 mg group = 363, 2 mg group = 344. Analysis populations (AP) for Month 6: 3 mg group = 87, 2 mg group: 92; Month 12: 3 mg group = 92, 2 mg group = 92; Month 24: 3 mg group = 83, 2 mg group = 85; Month 36: 3 mg group = 75, 2 mg group = 76.||Percent change||Standard Deviation|Mean
750265|NCT00551174|Secondary|Relative Percent Change From Baseline in Mean Total Hip BMD at 12, 24 and 36 Months|Relative change percent (%) from baseline of MA17904 and BM16550 (NCT00048074) in mean total hip BMD at 12, 24 and 36 months (i.e., 3, 4 and 5 years after initiation of BM16550)- Study MA17904. Percent change=[(measure at time t - measure at baseline)/measure at baseline]*100%, where t=12, 24 and 36 months. The baseline value is used as a reference to calculate the relative change from baseline.|Baseline,12, 24 and 36 months|ITT populations: 3 mg group = 394, 2 mg group = 362. Analysis populations (AP) for Month 12: 3 mg group = 381, 2 mg group = 347; Month 24: 3 mg group = 371, 2 mg group = 330; Month 36: 3 mg group = 349, 2 mg group = 314.||Percent change||Standard Deviation|Mean
750266|NCT00551174|Primary|Relative Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at 12, 24 and 36 Months|Relative change percent(%) from baseline of MA17904 and BM16550 (NCT00048074) in mean lumbar spine (L2-L4) BMD at 12, 24 and 36 months (i.e., 3, 4 and 5 years after initiation of BM16550)- Study MA17940.Percent change=[(measure at time t - measure at baseline)/measure at baseline]*100%, where t=12, 24 and 36 months. The baseline value is used as a reference to calculate the relative change from baseline.|Baseline,12, 24 and 36 months|ITT population: 3 mg group = 394, 2 mg group = 362. Analysis populations (AP) for Month 12: 3 mg group = 383, 2 mg group = 348; Month 24: 3 mg group = 374, 2 mg group = 332; Month 36: 3 mg group = 349, 2 mg group = 314.||Percent change||Standard Deviation|Mean
750267|NCT00551200|Primary|Number of Subjects Experienced Serious Adverse Events||during the period subjects on 100% Buphenyl (up to 4 weeks) or HPN-100 (up to 10 weeks)|||participants|||Number
750268|NCT00551200|Primary|Number of Subjects Experienced Adverse Events||during the period on 100% Buphenyl (up to 4 weeks) or HPN-100 (up to 10 weeks)|||participants|||Number
750269|NCT00551200|Secondary|Drug Preference for HPN-100 or Buphenyl® (as Assessed by Global Preference Question)||End of Study|||participants|||Number
750270|NCT00551200|Primary|Venous Ammonia Levels at the Peak and Mean TNUAC Time-normalized Area Under the Curve)|Data were collected at pre-first dose and at 30 minutes and 1, 2, 4, 5, 6, 8, 10, 12, and 24 hours post first dose.|At steady state (1 week) on each medication (Buphenyl® alone, HPN-100 alone), and at steady state (1 week) after each dose escalation|||μmol/L|concentration of ammonia|Standard Deviation|Mean
752643|NCT00561600|Secondary|Harris Hip Function Score at 24 Months|Mean Harris Hip Function sub score at 24 months|24 months|||units on a scale 0-47. 47 is best||Standard Deviation|Mean
750271|NCT00551200|Secondary|Pharmacokinetics (Plasma and Urine PK Parameters of Study Drugs and Their Metabolites)|measured AUC0-24 (Area under the curve from time 0 (pre-dose) to 24 hours) for each metabolite in plasma. Data were collected at 30 minutes and 1, 2, 4, 5, 6, 8, 10, 12, and 24 hours post-first dose.|At steady state (1 week) on each medication (Buphenyl® alone, HPN-100 alone)|||μg*h/mL|plasma|Standard Deviation|Mean
750272|NCT00551213|Secondary|Change From Baseline in Tumor Growth Rate|Tumor growth rate was assessed by CT or MRI scans using RECIST criteria at Screening, at every 8 weeks of robatumumab treatment and at post study. For Pre Baseline 1, tumor growth rate=(sum of longest diameter of target lesions at Baseline – the most recent prior to Baseline)/duration between Baseline and Pre Baseline. For all other cycles, tumor growth rate=(sum of longest diameter of target lesions at a cycle – Baseline)/ duration between Baseline and the cycle. The cycles presented below are relative to the first dose of robatumumab in Period 1.|Baseline and up to approximately 22 weeks|All participants who received ≥1 dose of robatumumab in Periods 1 and 2 were included in the analysis. No participants in the Chemotherapy→Robatumumab group received robatumumab in Period 1.||mm/day||Standard Deviation|Mean
750273|NCT00551213|Secondary|Best Overall Tumor Response Per Central Review|Tumor response was assessed by CT or MRI scan using RECIST v1.0 criteria at Screening, at every 8 weeks of robatumumab treatment during Period 2 and at post study. A sum of the LD for all target lesions was calculated and reported as the baseline sum LD. Overall tumor responses were defined as: Complete Response (CR) - Disappearance of all target lesions; Partial Response (PR) - At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD) - At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; or Stable Disease (SD) - Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Up to 30 days after last dose of study drug (Up to approximately 22 weeks)|All participants who received ≥1 dose of robatumumab were included in the analysis.||Participants|||Number
750274|NCT00551213|Secondary|Number of Participants Who Discontinued Study Drug Due to an AE|An AE is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the study drug. AEs may include the onset of new illness and the exacerbation of pre-existing conditions.|Up to last dose of study drug (Up to approximately 18 weeks)|All participants who received ≥1 dose of study drug were included in the analysis.||Participants|||Number
750275|NCT00551213|Secondary|Best Overall Tumor Response Per Investigator Review|Tumor response was assessed by computed tomography (CT) or magnetic resonance imaging (MRI) scans using RECIST v 1.0 criteria at Screening, at every 8 weeks of robatumumab treatment during Period 2 and at post study. A sum of the longest diameter (LD) for all target lesions was calculated and reported as the baseline sum LD. Overall tumor responses were defined as: Complete Response (CR) - Disappearance of all target lesions; Partial Response (PR) - At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD) - At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; or Stable Disease (SD) - Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Up to 30 days after last dose of study drug (Up to approximately 22 weeks)|All participants who received ≥1 dose of robatumumab were included in the analysis.||Participants|||Number
750276|NCT00551213|Secondary|Number of Participants Who Experienced One or More Adverse Events (AEs)|An AE is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the study drug. AEs may include the onset of new illness and the exacerbation of pre-existing conditions.|Up to 30 days after last dose of study drug (Up to approximately 22 weeks)|All participants who received ≥1 dose of study drug were included in the analysis.||Participants|||Number
750277|NCT00551213|Primary|Number of Participants With a >20% Decrease in Positron Emission Tomography (PET)-Assessed Tumor Glucose Metabolism: Fluorodeoxyglucose (FDG) Standardized Uptake Value (SUV) in the Target Lesion|FDG-PET was used in this study to detect the biological activity of modulation of the target within the tumor. Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 was used to select the target lesion. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs were identified as target lesions and recorded and measured at Baseline. The changes in SUVmax were calculated using the formula: (endpoint SUVmax – baseline SUVmax)/baseline SUVmax as a percentage. If multiple lesions had been measured at a visit, percentages calculated for all target lesions were averaged to find the decrease during the treatment period per participant. FDG SUVmax responder was defined as participants with >20% decrease in SUVmax after the first cycle of robatumumab in Period 2.|After the first robatumumab dose in Period 2 (Up to approximately 4 weeks after first robatumumab dose in Period 1)|All participants who received ≥1 dose of robatumumab in Periods 1 and 2 and had SUV data before and after the first dose of robatumumab in Period 2 were included in the analysis. No participants in the Chemotherapy→Robatumumab group received robatumumab in Period 1.||Participants|||Number
750278|NCT00551291|Secondary|Percentage of Participants With at Least One Adverse Event (AE)|An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events.|Up to approximately 2 years|||percentage of participants|||Number
750279|NCT00551291|Primary|Mean Number of Blood Transfusions Per Visit||Up to approximately 2 years|||transfusions/visit||Standard Deviation|Mean
750280|NCT00551291|Primary|Percentage of Participants With Clinical Response as Measured by the International Working Group (IWG) Criteria for Hematological Improvement|International Working Group (IWG) criteria for hematological improvement was defined as having hemoglobin (Hgb) <11 g/dL (pretreatment) and an increase in Hgb ≥1.5 g/dL after ≥8 weeks of treatment.|Up to approximately 2 years|||percentage of participants|||Number
750281|NCT00551369|Secondary|Prediction of Primary Tumor Control at 2 Years and Treatment-related Adverse Events ≥ Grade 2||From start of treatment to 2 years.||||||
750282|NCT00551369|Secondary|Level of Comorbidity Burden on Morbidity and Efficacy||From start of treatment to end of follow-up.||||||
750283|NCT00551369|Secondary|Primary Tumor Failure (PTF), Marginal Failure (MF), Regional Failure (RF), Metastatic Dissemination (MD), Disease-free Survival (DFS), and Overall Survival (OS) at 2 Years|PTF: the development of either failure within the SBRT treatment fields (in-field failure) or failure within 1.0 cm of the treatment field (marginal failure) within the first two years after start of SBRT. RF: the development of measurable tumor within lymph nodes along the natural lymphatic drainage typical for the location of the treated primary disease only with dimension of at least 1.0 cm on imaging studies (preferably CT scans) within the lung, bronchial hilum, or the mediastinum within the first two years after start of SBRT. MD: the appearance after protocol therapy of cancer deposits characteristic of metastatic dissemination from non-small cell lung cancer within the first two years after start of SBRT. DFS: the state of being alive without development of progressive disease, with failure considered the earliest development of either progression or death. OS: the state of being alive, with failure is considered death due to any cause.|From start of treatment to 2 years.|All eligible patients who started study treatment||percentage of participants||95% Confidence Interval|Number
750284|NCT00551369|Secondary|Other Grade 3-5 Adverse Events|The development of any treatment-related toxicity not from among the following: Gastrointestinal: dysphagia, esophagitis, esophageal stricture/stenosis, esophageal ulceration; Cardiac: pericarditis, pericardial effusion, restrictive cardiomyopathy, ventricular dysfunction (left ventricular diastolic dysfunction, left ventricular systolic dysfunction, right ventricular dysfunction); Neurologic: myelitis, neuropathy (cranial and motor); Hemorrhage: pulmonary or upper respiratory; Pulmonary: decline in pulmonary function as measured by pulmonary function tests (DLCO, FEV1,FVC), pneumonitis, pulmonary fibrosis, hypoxia, pleural effusion, cough, and dyspnea; Any grade 4 or 5 adverse event attributed to the therapy|From start of treatment to end of follow-up. Analysis can occur at or after time of primary outcome measure analysis.|All eligible patients who started study treatment||percentage of participants||95% Confidence Interval|Number
750285|NCT00551369|Secondary|Rate of Treatment-related Grade 3 or 4 Toxicity|The development of any treatment-related toxicity from among the following: Gastrointestinal: dysphagia, esophagitis, esophageal stricture/stenosis, esophageal ulceration; Cardiac: pericarditis, pericardial effusion, restrictive cardiomyopathy, ventricular dysfunction (left ventricular diastolic dysfunction, left ventricular systolic dysfunction, right ventricular dysfunction); Neurologic: myelitis, neuropathy (cranial and motor); Hemorrhage: pulmonary or upper respiratory; Pulmonary: decline in pulmonary function as measured by pulmonary function tests (DLCO, FEV1,FVC), pneumonitis, pulmonary fibrosis, hypoxia, pleural effusion, cough, and dyspnea; Any grade 4 or 5 adverse event attributed to the therapy|From start of treatment to end of follow-up. Analysis can occur at or after time of primary outcome measure analysis.|All eligible patients who started study treatment||percentage of participants||95% Confidence Interval|Number
750286|NCT00551369|Primary|Primary Tumor Control at 2 Years|Primary tumor control is defined as the absence of primary tumor failure by 2 years after the start of SBRT. Primary tumor failure was considered as the development of either failure within the SBRT treatment fields (in-field failure) or failure within 1.0 cm of the treatment field (marginal failure). An acceptable tumor control rate at 2 years was considered to be 90% (monthly hazard of 0.00439), and an unacceptable rate was 70% (monthly hazard of 0.01486). A one-sided type 1 error of 0.05 and statistical power of 90% was used. A one-sided Z-test was used to determine if the difference between the logarithm of the observed hazard rate and the logarithm of the hypothesized hazard rate of 0.01486 was statistically significant.|From start of treatment to 2 years.|All eligible patients who started study treatment||percentage of patients||95% Confidence Interval|Number
750287|NCT00551421|Secondary|Overall Survival|The duration of time from start of study treatment to death from any cause.|The duration of time from start of study treatment to death from any cause.|||months||95% Confidence Interval|Median
750288|NCT00551421|Secondary|Progression-free Survival|The duration of time from start of study treatment to time of objective disease progression or death.|The duration of time from start of study treatment to time of objective disease progression or death.|||months||95% Confidence Interval|Median
750289|NCT00551421|Primary|Objective Tumor Response Rate Defined as the Proportion of Patients With a Best Overall Response of CR or PR, Per RECIST Criteria (Phase II)|Objective tumor response rate defined as the proportion of patients with a best overall response of CR or PR, per RECIST criteria (Phase II).|Best tumor response from time period of start of study treatment to study discontinuation.|||percentage of patients|||Number
750290|NCT00551421|Primary|Recommended Phase II Dose of Pertuzumab When Administered in Combination With Cetuximab (Phase I)|The regimen was deemed intolerable so there was no recommended phase II dose.|28 days||||||Number
750291|NCT00551525|Secondary|Freedom From Progression (FFP) Rate at 2 Years|"Progression is defined as biochemical (PSA) failure at any time for 2 years after prostatic fossa radiation therapy (RT), initiation of systemic therapy, or clinical failure. Biochemical failure is defined as a rise of 0.2 ng/ml or more above the nadir PSA after completion of RT followed by another higher value, or a continued rise in the serum PSA despite RT. FFP rate at 2 years was to be compared to that predicted by the Kattan Nomograms. See Limitations and Caveats section."|From randomization to 2 years|Eligible patients who started study treatment||percentage of participants||95% Confidence Interval|Number
750292|NCT00551525|Secondary|Acute and Late Radiotherapy-Related Adverse Events|The number of patients who experienced a grade 1-5 radiation-related adverse events within 90 days of the start of radiotherapy (acute) and after 90 days (late). Adverse events are evaluated by the NCI Common Terminology Criteria for Adverse Event (CTCAE) version 3.0. Multivariate logistic regression was used to model the association of clinical T-stage (pT2 vs. pT3 [reference level]), baseline PSA, Gleason score (<8 vs. 8-10[reference level]), and age with the occurrence of any acute radiotherapy-related adverse event. Odds ratios and the respective 95% confidence intervals were computed for each factor. Per the protocol, late adverse events were not analyzed.|90 days from start of radiotherapy|Eligible patients with adverse event data||participants|||Number
750309|NCT00551746|Primary|Compare Change in Platelet Aggregation as Measured by Adenosine Diphosphate (ADP) Between PGJ and Placebo|Platelet aggregation was measured using the agonist ADP (10 microM) in a light transmission aggregometer and compared between PGJ and placebo via the intent-to-treat paradigm.|90-days|The number of participants evaluated were those who had both a baseline and visit 4 platelet aggregation and platelet-dependant inflammatory marker values||percent||Standard Deviation|Mean
752644|NCT00561600|Secondary|Harris Hip Pain Sub Score at 24 Months|Mean Harris Hip Pain sub score|24 months|||units on scale of 0-44. 44 is best||Standard Deviation|Mean
750293|NCT00551525|Secondary|Samarium 153-related Adverse Events at 12 Weeks (Percentage of Patients)|"Adverse events are evaluated by the NCI Common Terminology Criteria for Adverse Event (CTCAE) version 3.0. The treatment-related attribution includes definitely, probably or possibly related to treatment. The treatment-related adverse events are:
HEMATOLOGIC Platelet grade 3-5 White blood cell count (WBC) grade 3-5 Hemoglobin grade 3-5 Any secondary leukemia’s
HEMORRHAGE/BLEEDING Hemorrhage, gastrointestinal - anus, rectum grade 3-5 Hemorrhage, genitourinary - bladder, prostate, urethra grade 3-5
SAMARIUM 153-RELATED GRADE 5 ADVERSE EVENT PRIOR TO TREATMENT OF RADIATION."|Twelve weeks from the date of Samarium 153 infusion|Eligible patients with adverse event data||percentage of participants|||Number
750294|NCT00551525|Secondary|Number of Patients With Hematologic Toxicity at 12 Weeks|Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. Hematological toxicities consist of platelet grade 3-5, white blood cell grade 3-5, hemoglobin grade 3-5, and any secondary leukemia's.|Twelve weeks from the date of Samarium 153 infusion.|Eligible patients who started study treatment||Participants|||Count of Participants
750295|NCT00551525|Secondary|Completion of Therapy|The completion of protocol treatment is defined as receiving at least 64.8 Gy radiation after the Samarium 153 injection. The null hypothesis that the proportion of the number of patients who complete the protocol treatment (the Samarium 153 and the radiation therapy) is less than or equal to 0.5 was tested using an exact test for a binomial proportion. If the true treatment completion proportion is 0.8, then the statistical power of a one-sided 0.378 level exact binomial test of proportion would be 94.1% with the sample size of 26. Therefore any number of analyzable patients greater than 26 patients provides enough power for this endpoint.|90 days from the end of radiation therapy.|All eligible patients who started treatment and did not withdraw consent prior to 90 days from the end of radiation therapy||percentage of participants||95% Confidence Interval|Number
750296|NCT00551525|Primary|Proportion of Patients With PSA Response (pt) Within 12 Weeks of Samarium 153 Administration|A PSA response for each patient is calculated by (baseline PSA-current PSA)/baseline PSA. A decline of at least 30% is considered a response. Null hypothesis (H0): Samarium 153 is not effective (pt ≤ 0.1) vs alternative hypothesis (HA): Samarium 153 is effective (pt ≥ 0.25). The sample size of 69 analyzable patients (eligible patients receiving any protocol treatment with ≥ 12 weeks follow-up from the Samarium 153 injection) was calculated based on Fleming’s Multiple Testing Procedure at a significance level of 0.019 and 91% statistical power requiring 69 patients to conclude either the null or alternative hypotheses. With only 52 analyzable patients this study had only 78% power and needed at least 11 patients with a PSA response to reject H0.|Twelve weeks from the date of Samarium 153 infusion.|All eligible patients who received Samarium 153 with at least 12 weeks follow-up from the injection||percentage of participants|||Number
750297|NCT00551642|Secondary|Methemoglobin Level||Baseline, then 24 hours, 2-6 days, Day 7 and Day 14 of treatment||||||
750298|NCT00551642|Secondary|Adverse Events||Study Duration||||||
750299|NCT00551642|Secondary|Arterial Oxygen Saturation by Pulse Oximetry||Study Duration||||||
750300|NCT00551642|Secondary|Vital Signs||Study Duration||||||
750301|NCT00551642|Primary|Survival||36 Weeks GA||||||
750302|NCT00551642|Primary|Survival Without Bronchopulmonary Dysplasia (BPD) in Preterm Infants With Respiratory Distress|The primary outcome was determined by assessment of survival and incidence of BPD,which was defined by the need for supplemental oxygen at 36 weeks gestational age (GA); an infant who was alive without BPD at 36 weeks GA was counted as success; an infant who died or had BPD at 36 weeks GA was counted as a failure.|36 weeks gestational age|||participants alive without BPD|||Number
750303|NCT00551707|Secondary|To Assess the Efficacy of CRx-102 Compared to Placebo Using ACR 20 Calculated From Baseline to Day 98|Preliminary review of the efficacy dataset revealed that the efficacy dataset was not robust enough to support an extensive formal efficacy analysis as described in the SAP. Therefore, only the CRP values over time and the percent change in CRP values in the As-Treated population were calculated.|baseline to 98 Days||||||
750304|NCT00551707|Primary|Absolute C-reactive Protein (CRP) Values at Day 98 - As Treated Population|Preliminary review of the efficacy dataset revealed that the efficacy dataset was not robust enough to support an extensive formal efficacy analysis as described in the SAP. Therefore, only the CRP values over time and the percent change in CRP values in the As-Treated population were calculated.|Day 98|As treated population||mg/L||Full Range|Median
750305|NCT00551707|Secondary|To Assess the Superiority of CRx-102 Compared to Prednisolone and Dipyridamole Using American College of Rheumatology Rating Scale (20% or More Improvement; ACR20) Calculated From Baseline to Day 98 in Subjects With Active Rheumatoid Arthritis|Preliminary review of the efficacy dataset revealed that the efficacy dataset was not robust enough to support an extensive formal efficacy analysis as described in the SAP. Therefore, only the CRP values over time and the percent change in CRP values in the As-Treated population were calculated.|baseline to day 98||||||
750306|NCT00551707|Secondary|Percent Change From Baseline to Day 98 in C-reactive Protein (CRP) Values - As Treated Population|Preliminary review of the efficacy dataset revealed that the efficacy dataset was not robust enough to support an extensive formal efficacy analysis as described in the SAP. Therefore, only the CRP values over time and the percent change in CRP values in the As-Treated population were calculated.|baseline to day 98|As treated population||percentage of change from baseline||Full Range|Median
750307|NCT00551746|Secondary|The Impact of Polymorphism in Haemostatic Genes on Variation in Platelet Function Among Participants Based on Long-term PGJ Consumption.||90-days||||||
750308|NCT00551746|Secondary|Compare Platelet Inhibitory Pathways of ADP,TRAP, PMA, Arachadonic Acid Between PGJ and Placebo.|The platelet inhibitory pathway in which PGJ functions by performing platelet aggregation tests using agonists for the 4 major platelet activation pathways: ADP,thrombin receptor-activator peptide (TRAP), phorbol 12-myristate 13-acetate (PMA), arachadonic acid(10 microM) in a light transmission aggregometer and compared between PGJ and placebo via the intent-to-treat paradigm.|90-days||||||
750511|NCT00553332|Secondary|Median Progression Free Survival for Patients|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Up to 6 months|||months||95% Confidence Interval|Median
750310|NCT00551759|Primary|Proportion of Patients With Pathologic Complete Response|After neoadjuvant therapy, participants underwent surgical resection. The excised tumor was examined by a pathologist. A pathologic complete response is defined as the absence of any histopathologic evidence of tumor in the resected esophageal and nodal tissue specimen.|At time of surgery (which occurred 63 to 91 days after study entry)|Eligible and treated patients||Proportion of patients||90% Confidence Interval|Number
750353|NCT00552175|Secondary|Change From Baseline in Brief Pain Inventory Interference Scores at Week 12|The Interference scores range from 0 (does not interfere) to 10 (completely interferes). There are 7 questions assessing the interference of pain in the past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Each question has a total range of scores from 0 to 10.|Baseline, Week 12|Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.||units on a scale||Standard Error|Least Squares Mean
750331|NCT00552058|Secondary|Percentage of Subjects in Subgroup With 10 mg/L or Greater C-reactive Protein (CRP) at Entry Achieving a Clinical Response at Week 6|The percentage of subjects in the subgroup with 10 mg/L or greater C-reactive Protein (CRP) at Entry achieving a clinical response at Week 6 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.|Week 0, Week 6|Of the 215 (Certolizumab Pegol 400 mg) and 209 (Placebo) subjects in the Intent-to-treat (ITT) population, 93 and 96 subjects are in the 10 mg/L or greater C-reactive Protein (CRP) subgroup at Entry, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose||percentage of subjects||95% Confidence Interval|Number
750332|NCT00552058|Secondary|Percentage of Subjects in Subgroup With Less Than 10 mg/L C-reactive Protein (CRP) at Entry Achieving a Clinical Response at Week 6|The percentage of subjects in the subgroup with less than 10 mg/L C-reactive Protein (CRP) at Entry achieving a clinical response at Week 6 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.|Week 0, Week 6|Of 215 (Certolizumab Pegol 400 mg) and 209 (Placebo) subjects in the Intent-to-treat (ITT) population, 122 and 113 subjects are in the less than 10 mg/L C-reactive Protein (CRP) subgroup at Entry, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.||percentage of subjects||95% Confidence Interval|Number
750333|NCT00552058|Secondary|Percentage of Subjects in Subgroup With 10 mg/L or Greater C-reactive Protein (CRP) at Entry Who Are in Clinical Remission at Week 6|The percentage of subjects in the subgroup with 10 mg/L or greater C-reactive Protein (CRP) at Entry in clinical remission at Week 6 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.|Week 6|Of the 215 (Certolizumab Pegol 400 mg) and 209 (Placebo) subjects in the Intent-to-treat (ITT) population, 93 and 96 subjects are in the 10 mg/L or greater C-reactive Protein (CRP) subgroup at Entry, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.||percentage of subjects||95% Confidence Interval|Number
750370|NCT00552240|Secondary|Number of Participants With Genotypic Resistance at the Time of Virologic Failure.|Genotypic resistance was measured by the following: Plasma samples for HIV-1 resistance were analyzed using a standard clinical assay that generates a virtual phenotypic interpretation of HIV-1 sequence data and predicts susceptibility or resistance of the isolate to approved ARVs. This analysis has not been performed.|baseline to week 48|Includes only treated patients with data in the specified time window|||||
750334|NCT00552058|Secondary|Percentage of Subjects in Subgroup With Less Than 10 mg/L C-reactive Protein (CRP) at Entry Who Are in Clinical Remission at Week 6|The percentage of subjects in the subgroup with less than 10 mg/L of C-reactive Protein (CRP) at Entry who are in clinical remission at Week 6 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.|Week 6|Of 215 (Certolizumab Pegol 400 mg) and 209 (Placebo) subjects in the Intent-to-treat (ITT) population, 122 and 113 subjects are in the less than 10 mg/L C-reactive Protein (CRP) subgroup at Entry, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.||percentage of subjects||95% Confidence Interval|Number
750335|NCT00552058|Secondary|Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 4|The percentage of subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) remission at Week 4 (IBDQ remission is defined as a total IBDQ score of 170 points or more). The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 4|Of the 223 (Certolizumab Pegol 400 mg) and 216 (Placebo) subjects randomized, 215 and 209 subjects are included in the Intent-to-treat (ITT) population, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.||percentage of subjects||95% Confidence Interval|Number
750336|NCT00552058|Secondary|Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 2|The percentage of subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) remission at Week 2 (IBDQ remission is defined as a total IBDQ score of 170 points or more). The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 2|Of the 223 (Certolizumab Pegol 400 mg) and 216 (Placebo) subjects randomized, 215 and 209 subjects are included in the Intent-to-treat (ITT) population, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.||percentage of subjects||95% Confidence Interval|Number
750337|NCT00552058|Secondary|Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 4|The change in total Crohn's Disease Activity Index (CDAI) score from Week 0 to Week 4. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.|Week 0, Week 4|Of the 215 (Certolizumab Pegol 400 mg) and 209 (Placebo) subjects in the Intent-to-treat (ITT) population, 198 and 184 subjects respectively are included in this summary and have assessments at both Weeks 0 and 4. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.||score on a scale||Standard Deviation|Mean
750338|NCT00552058|Secondary|Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 2|The change in total Crohn's Disease Activity Index (CDAI) score from Week 0 to Week 2. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.|Week 0 to Week 2|Of the 215 (Certolizumab Pegol 400 mg) and 209 (Placebo) subjects in the Intent-to-treat (ITT) population, 204 and 198 subjects respectively are included in this summary and have assessments at both Weeks 0 and 2. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.||score on a scale||Standard Deviation|Mean
750339|NCT00552058|Secondary|Percentage of Subjects Achieving a Clinical Response at Week 4|The percentage of subjects achieving a clinical response at Week 4 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.|Week 0, Week 4|Of the 223 (Certolizumab Pegol 400 mg) and 216 (Placebo) subjects randomized, 215 and 209 subjects are included in the Intent-to-treat (ITT) population, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.||percentage of subjects||95% Confidence Interval|Number
750340|NCT00552058|Secondary|Percentage of Subjects Achieving a Clinical Response at Week 2|The percentage of subjects achieving a clinical response at Week 2 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.|Week 0, Week 2|Of the 223 (Certolizumab Pegol 400 mg) and 216 (Placebo) subjects randomized, 215 and 209 subjects are included in the Intent-to-treat (ITT) population, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.||percentage of subjects||95% Confidence Interval|Number
750341|NCT00552058|Secondary|Percentage of Subjects in Clinical Remission at Week 4|The percentage of subjects in clinical remission at Week 4 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.|Week 4|Of the 223 (Certolizumab Pegol 400 mg) and 216 (Placebo) subjects randomized, 215 and 209 subjects are included in the Intent-to-treat (ITT) population, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.||percentage of subjects||95% Confidence Interval|Number
750342|NCT00552058|Secondary|Percentage of Subjects in Clinical Remission at Week 2|The percentage of subjects in clinical remission at Week 2 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.|Week 2|Of the 223 (Certolizumab Pegol 400 mg) and 216 (Placebo) subjects randomized, 215 and 209 subjects are included in the Intent-to-treat (ITT) population, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.||percentage of subjects||95% Confidence Interval|Number
750343|NCT00552058|Secondary|Change in Harvey Bradshaw Index (HBI) Score From Week 0 to Week 6|The change in Harvey Bradshaw Index (HBI) score from Week 0 to Week 6. HBI score consists of clinical parameters of general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (score 1 per item). The first three items are scored for the previous day. Lower scores indicated better well being.|Week 0 to Week 6|Of the 215 (Certolizumab Pegol 400 mg) and 209 (Placebo) subjects in the Intent-to-treat (ITT) population, 196 and 187 subjects respectively are included in this summary and have assessments at both Weeks 0 and 6. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.||score on a scale||Standard Deviation|Mean
750344|NCT00552058|Secondary|Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 6|The change in total Crohn's Disease Activity Index (CDAI) score from Week 0 to Week 6. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.|Week 0 to Week 6|Of the 215 (Certolizumab Pegol 400 mg) and 209 (Placebo) subjects in the Intent-to-treat (ITT) population, 192 and 183 subjects respectively are included in this summary and have assessments at both Weeks 0 and 6. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.||score on a scale||Standard Deviation|Mean
750345|NCT00552058|Secondary|Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 6|The percentage of subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) remission at Week 6 (IBDQ remission is defined as a total IBDQ score of 170 points or more). The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 6|Of the 223 (Certolizumab Pegol 400 mg) and 216 (Placebo) subjects randomized, 215 and 209 subjects are included in the Intent-to-treat (ITT) population, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.||percentage of subjects||95% Confidence Interval|Number
750346|NCT00552058|Secondary|Percentage of Subjects Achieving a Clinical Response at Week 6|The percentage of subjects achieving a clinical response at Week 6 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates clinical remission and a score above 450 points indicates extremely severe disease.|Week 0, Week 6|Of the 223 (Certolizumab Pegol 400 mg) and 216 (Placebo) subjects randomized, 215 and 209 subjects are included in the Intent-to-treat (ITT) population, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.||percentage of subjects||95% Confidence Interval|Number
750347|NCT00552058|Primary|Percentage of Subjects in Clinical Remission at Week 6|The percentage of subjects in clinical remission at Week 6 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.|Week 6|Of the 223 (Certolizumab Pegol 400 mg) and 216 (Placebo) subjects randomized, 215 and 209 subjects are included in the Intent-to-treat (ITT) population, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.||percentage of subjects||95% Confidence Interval|Number
750348|NCT00552084|Primary|Documented Recurrence of Atrial Fibrillation/Atrial Flutter|Trans-telephonic electrocardiographic monitoring (TTM) device were used to send transmissions every 2 weeks and each time a participant had symptoms suggestive of arrhythmia.|Measured at Week 24 or exit|||percentage of participants|||Number
750349|NCT00552110|Primary|Standardized Area Under the Curve From 0 to 4 Hours [AUC(0-4 hr)] of the Change From Baseline to Hour 4 on Day 1 in Nasal Congestion Score|Subjects scored nasal congestion/stuffiness using an ordinal scale from 0 = none to 3 = severe. Baseline was the average of the scores assessed every 15 minutes for 1 hour prior to dosing on Day 1. After dosing on Day 1, congestion was scored every 15 minutes for the 1st hour and every 30 minutes for the next 3 hours. Area under the curve (AUC) was calculated using the trapezoid rule, then standardization achieved by dividing the calculation by 4 hours. Treatment comparisons were examined using the standardized AUC(0-4 hr) of the change from baseline to hour 4 on Day 1.|from baseline to hour 4 on Day 1|Intention to treat: all randomized subjects who had taken at least one dose of study drug||units on a scale||Standard Error|Least Squares Mean
750350|NCT00552110|Primary|Change From Baseline in AM/PM Instantaneous Total Nasal Symptom Score (NOW TNSS) Averaged Over Days 1 to 15|Subjects scored severity of rhinorrhea, nasal congestion/stuffiness, nasal itching, and sneezing at the time of evaluation (NOW) using an ordinal scale from 0 = none to 3 = severe. Evaluations were performed daily in the morning (AM) and evening (PM). For each evaluation, individual symptom scores were summed to a TNSS, which was then averaged for a single score across the 15 day treatment period.|15 days of treatment|Intention to treat (ITT): all randomized subjects who had taken at least one dose of study drug||units on a scale||Standard Error|Least Squares Mean
750351|NCT00552175|Secondary|Change From Baseline in Beck Depression Inventory-II (BDI-II) Total Score at Week 12|A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score ranges from 0 (no depression) to 63 (severe depression).|Baseline, Week 12|Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.||units on a scale||Standard Error|Least Squares Mean
750352|NCT00552175|Secondary|Change From Baseline in Beck Depression Inventory-II (BDI-II) Total Score at Week 12 for the Combined Duloxetine Arms (40 mg + 60 mg)|A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score ranges from 0 (no depression) to 63 (severe depression).|Baseline, Week 12|Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.||units on a scale||Standard Error|Least Squares Mean
750371|NCT00552240|Secondary|Percentage Adherence by Pill Count|Number of pills not returned / number of treatment days in percent (%)|baseline to week 48|All treated patients with data||percentage adherence||Standard Deviation|Mean
750354|NCT00552175|Secondary|Change From Baseline in Brief Pain Inventory Interference Scores at Week 12 for the Combined Duloxetine Arms (40 mg + 60 mg)|The Interference scores range from 0 (does not interfere) to 10 (completely interferes). There are 7 questions assessing the interference of pain in the past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Each question has a total range of scores from 0 to 10.|Baseline, Week 12|Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.||units on a scale||Standard Error|Least Squares Mean
750355|NCT00552175|Secondary|Change From Baseline in Brief Pain Inventory Severity Scores at Week 12|A self-reported scale that measures the severity of pain. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). There are 4 questions assessing worst pain, least pain, and average pain in the past 24 hours, and the pain right now. Each question has a total range of scores from 0 to 10.|Baseline, Week 12|Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.||units on a scale||Standard Error|Least Squares Mean
750356|NCT00552175|Secondary|Change From Baseline in Brief Pain Inventory Severity Scores at Week 12 for the Combined Duloxetine Arms (40 mg + 60 mg)|A self-reported scale that measures the severity of pain. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). There are 4 questions assessing worst pain, least pain, and average pain in the past 24 hours, and the pain right now. Each question has a total range of scores from 0 to 10.|Baseline, Week 12|Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.||units on a scale||Standard Error|Least Squares Mean
750357|NCT00552175|Secondary|Patient Global Impression of Improvement Scale at Week 12|A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).|Week 12|Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.||units on a scale||Standard Error|Least Squares Mean
750358|NCT00552175|Secondary|Patient Global Impression of Improvement Scale at Week 12 in Combined Duloxetine Arms (40 mg + 60 mg)|A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).|Week 12|Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.||units on a scale||Standard Error|Least Squares Mean
750359|NCT00552175|Secondary|Change From Baseline at Week 12 in Worst Pain Severity Score and Night Pain Severity Score Using Diaries|Pain severity for worst pain and night pain as measured by an 11-point numerical rating scale, collected by diaries and expressed as weekly means. A self-reported scale that measures the severity of pain based on the worst pain and night pain experienced over the past 24-hours. The worst pain and night pain severity scores each range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline, Week 12|Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.||units on a scale||Standard Error|Least Squares Mean
750360|NCT00552175|Secondary|Change From Baseline at Week 12 in Worst Pain Severity Score and Night Pain Severity Score Using Diaries for the Combined Duloxetine Arms (40 mg + 60 mg)|Pain severity for worst pain and night pain as measured by an 11-point numerical rating scale, collected by diaries and expressed as weekly means. A self-reported scale that measures the severity of pain based on the worst pain and night pain experienced over the past 24-hours. The worst pain and night pain severity scores each range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline, 12 weeks|Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.||units on a scale||Standard Error|Least Squares Mean
750361|NCT00552175|Secondary|Change From Baseline at Week 12 in Average Pain Severity Rating Score Using Diaries|Average pain severity was measured using an 11-point numerical rating scale, collected by diaries and expressed as weekly mean. The scale is a self-reported instrument that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline, 12 weeks|Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.||units on a scale||Standard Error|Least Squares Mean
750362|NCT00552175|Primary|Change From Baseline at Week 12 in Average Pain Severity Rating Using Diaries for the Combined Duloxetine Arms (40 mg + 60 mg)|Average pain severity was measured using an 11-point numerical rating scale, collected by diaries and expressed as weekly mean. The scale is a self-reported instrument that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline, 12 weeks|Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.||units on a scale||Standard Error|Least Squares Mean
750363|NCT00552188|Secondary|Change From Baseline in Plaque Imaging After 6 Weeks|To evaluate the effect of VIA-2291 100 mg relative to placebo on the change from baseline in the TBR from an index vessel (either right carotid, left carotid or ascending aorta) based on the standardized 18FDG uptake measured with PET in patients after 6 weeks of daily dosing.|Baseline and 6 Weeks|Evaluable Population||TBR||95% Confidence Interval|Least Squares Mean
750364|NCT00552188|Primary|Change From Baseline in Plaque Imaging After 24 Weeks|To evaluate the effect of VIA-2291 100 mg relative to placebo on the change from baseline in the target (plaque) to background (blood) ratio (TBR) from an index vessel (either right carotid, left carotid or ascending aorta) based on the standardized 18fluorodeoxy glucose (FDG) uptake measured with PET in patients with acute coronary syndrome and vascular inflammation after 24 weeks of daily dosing.|Baseline and 24 Weeks|Evaluable Population||TBR||95% Confidence Interval|Least Squares Mean
750365|NCT00552240|Secondary|Proportion of Patients With DAIDS Grade >= 2 Laboratory Abnormalities||baseline to week 52|All treated patients||participants|||Number
750366|NCT00552240|Secondary|Proportion of Patients Reporting Rash of Any Severity||baseline to week 52|All treated patients||participants|||Number
750367|NCT00552240|Secondary|Proportion of Patients Reporting Hepatic Events of Any Severity||baseline to week 52|All treated patients||participants|||Number
750368|NCT00552240|Secondary|Proportion of Patients Reporting CNS Side Effects of Any Severity||baseline to week 52|All treated patients||participants|||Number
750369|NCT00552240|Secondary|Incidence of Patients With AIDS Progression at Each Visit|Cumulative incidence of patients with AIDS progression are shown|baseline to week 52|Full Analysis set||participants|||Number
750374|NCT00552240|Secondary|Change in Framingham Score|Framingham prediction of 10-year risk of Coronary Heart Disease (CHD) outcomes (myocardial infarction [MI] or CHD death) based on the patient’s gender, age, systolic blood pressure, total cholesterol, HDL-c and smoking status. The scale for the estimated risk ranges from 0 to 30%.|baseline to week 48|All treated patients with data, Last observation carried forward (LOCF)||percent 10-year risk||Standard Deviation|Mean
750375|NCT00552240|Secondary|Change in Fasting Total Cholesterol to High Density Lipoprotein (HDL) Ratio||baseline to week 48|All treated patients with data, Last observation carried forward (LOCF)||ratio||Standard Deviation|Mean
750376|NCT00552240|Secondary|Change in Fasting Low Density Lipoprotein (LDL)Cholesterol Level||baseline to week 48|All treated patients with data, Last observation carried forward (LOCF)||mg/dl||Standard Deviation|Mean
750377|NCT00552240|Secondary|Change in Fasting High Density Lipoprotein (HDL) Cholesterol Level||baseline to week 48|All treated patients with data, Last observation carried forward (LOCF)||mg/dl||Standard Deviation|Mean
750378|NCT00552240|Secondary|Change in Fasting Plasma Triglycerides Level||baseline to week 48|All treated patients with data, Last observation carried forward (LOCF)||mg/dl||Standard Deviation|Mean
750379|NCT00552240|Secondary|Change in Fasting Plasma Total Cholesterol Level||baseline to week 48|All treated patients with data, Last observation carried forward (LOCF).||mg/dl||Standard Deviation|Mean
750380|NCT00552240|Secondary|Change in CD4+ Cell Count From Baseline to Week 48.|Patients on-treatment, data within time windows|baseline to week 48|Includes only treated patients with data in the specified time window||cells/mm^3||Standard Deviation|Mean
750381|NCT00552240|Secondary|Change in CD4+ Cell Count From Baseline to Week 36.|Patients on-treatment, data within time windows|baseline to week 36|Includes only treated patients with data in the specified time window||cells/mm^3||Standard Deviation|Mean
750382|NCT00552240|Secondary|Change in CD4+ Cell Count From Baseline to Week 24.|Patients on-treatment, data within time windows|baseline to week 24|Includes only treated patients with data in the specified time window||cells/mm^3||Standard Deviation|Mean
750383|NCT00552240|Secondary|Change in CD4+ Cell Count From Baseline to Week 12.|Patients on-treatment, data within time windows|baseline to week 12|Includes only treated patients with data in the specified time window||cells/mm^3||Standard Deviation|Mean
750384|NCT00552240|Secondary|Change in CD4+ Cell Count From Baseline to Week 8.|Patients on-treatment, data within time windows|baseline to week 8|Includes only treated patients with data in the specified time window||cells/mm^3||Standard Deviation|Mean
750385|NCT00552240|Secondary|Change in CD4+ Cell Count From Baseline to Week 6.|Patients on-treatment, data within time windows|baseline to week 6|Includes only treated patients with data in the specified time window||cells/mm^3||Standard Deviation|Mean
750386|NCT00552240|Secondary|Change in CD4+ Cell Count From Baseline to Week 4.|Patients on-treatment, data within time windows|baseline to week 4|Includes only treated patients with data in the specified time window||cells/mm^3||Standard Deviation|Mean
750387|NCT00552240|Secondary|Change in CD4+ Cell Count From Baseline to Week 2.|Patients on-treatment, data within time windows|baseline to week 2|Includes only treated patients with data in the specified time window||cells/mm^3||Standard Deviation|Mean
750388|NCT00552240|Secondary|AIDS Progression and Death: Number of Patients With a Treatment-emergent AIDS Defining Illness or an AIDS-defining Illness Leading to Death|"AIDS defining illnesses include: Aspergillosis, Bartonellosis, Candidiasis, Cervical cancer, Chagas disease, Coccidiodomycosis, Cryptococcosis, Cytomegalovirus retinus, encephalopathy, Herpes Simplex Virus, Histoplasmosis, Isosporiasis, Kaposi’s sarcoma, Leishmaniasis, Microsporidiosis, Mycobacterium avium complex, mycobacterium (non-tuberculous), Nocardiosis, Pneumocystis carinii pneumonia, Pneumonia, Progressive Multifocal Leukoencephalopathy, Rhodococcus equi, Salmonella, Toxoplasmosis, Wasting.
Number of cases (no time-to analysis was performed due to small numbers)."|baseline to week 48|All treated patients||Participants|||Number
750389|NCT00552240|Secondary|Number of Patients With Virologic Rebound to >400 Copies/ml|HIV viral load >400 copies/ml on two consecutive measurements separated by at least 2 weeks, after confirmed virologic response (2 consecutive HIV viral load values < 50 copies/ml)|baseline to week 48|All treated patients||Participants|||Number
750390|NCT00552240|Secondary|Number of Participants With HIV Viral Load < 400 Copies/ml at Week 48 of Treatment|Results within time windows, patients on-treatment|baseline to week 48|All treated patients||Participants|||Number
750391|NCT00552240|Secondary|Number of Participants With HIV Viral Load < 400 Copies/ml at Week 36 of Treatment|Results within time windows, patients on-treatment|baseline to week 36|All treated patients||Participants|||Number
750392|NCT00552240|Secondary|Number of Participants With HIV Viral Load < 400 Copies/ml at Week 24 of Treatment|Results within time windows, patients on-treatment|baseline to week 24|All treated patients||Participants|||Number
750393|NCT00552240|Secondary|Number of Participants With HIV Viral Load < 400 Copies/ml at Week 12 of Treatment|Results within time windows, patients on-treatment|baseline to week 12|All treated patients||Participants|||Number
750394|NCT00552240|Secondary|Number of Participants With HIV Viral Load < 400 Copies/ml at Week 8 of Treatment|Results within time windows, patients on-treatment|baseline to week 8|All treated patients||Participants|||Number
750395|NCT00552240|Secondary|Number of Participants With HIV Viral Load < 400 Copies/ml at Week 6 of Treatment|Results within time windows, patients on-treatment|baseline to week 6|All treated patients||Participants|||Number
750396|NCT00552240|Secondary|Number of Participants With HIV Viral Load < 400 Copies/ml at Week 4 of Treatment|Results within time windows, patients on-treatment|baseline to week 4|All treated patients||Participants|||Number
750397|NCT00552240|Secondary|Number of Participants With HIV Viral Load < 400 Copies/ml at Week 2 of Treatment|Results within time windows, patients on-treatment|baseline to week 2|All treated patients||Participants|||Number
750398|NCT00552240|Secondary|Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48 of Treatment|Results within time windows, patients on-treatment|baseline to week 48|All treated patients||Participants|||Number
750399|NCT00552240|Secondary|Number of Participants With HIV Viral Load < 50 Copies/ml at Week 36 of Treatment|Results within time windows, patients on-treatment|baseline to week 36|All treated patients||Participants|||Number
750400|NCT00552240|Secondary|Number of Participants With HIV Viral Load < 50 Copies/ml at Week 24 of Treatment|Results within time windows, patients on-treatment|baseline to week 24|All treated patients||Participants|||Number
750406|NCT00552240|Secondary|Number of Participants With Loss of Virologic Response Following Confirmed Virologic Response|HIV viral load > 50 copies/ml on two consecutive measurements separated by at least 2 weeks, after confirmed virologic response (2 consecutive HIV viral load values < 50 copies/ml)|baseline to week 24 and week 48|All treated patients; Too few patients had a loss of virologic response for a reasonable analysis of time to loss.||Participants|||Number
750407|NCT00552240|Secondary|Time to Virologic Response (First Confirmed Viral Load < 50 Copies/ml), Only Participants With Confirmed Viral Load < 50 Copies/ml||baseline to week 48|All responders||days||Inter-Quartile Range|Median
750408|NCT00552240|Secondary|Time to Virologic Response (First Confirmed Viral Load < 50 Copies/ml), All Participants|Time to response whereby patients withdrawing early were censored after their withdrawal|baseline to week 48|All treated patients||days||Inter-Quartile Range|Median
750409|NCT00552240|Secondary|Number of Participants With Virologic Success (FDA Definition)|HIV viral load <50 copies/ml measured in the Week 48 window whereby patients withdrawing early and patients without a Week 48 assessment are considered failures. Includes all participants in full analysis set (FAS).|baseline to week 48|All treated patients.||Participants|||Number
750410|NCT00552240|Secondary|Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48|HIV viral load <50 copies/ml measured at Week 48 among observed cases on-treatment.|baseline to week 48|Only includes treated patients with data in the Week 48 time window.||Participants|||Number
750411|NCT00552240|Secondary|Number of Participants With Virologic Response According to the Time to Loss of Virologic Response (TLOVR) Algorithm|HIV viral load <50 copies/ml measured at two consecutive visits UP TO Week 48 and without subsequent rebound or change of ARV therapy up to Week 48.|baseline to week 48|All treated patients. Early withdrawals were considered failures.||Participants|||Number
750412|NCT00552240|Primary|Number of Participants With Virologic Response (VR)|VR is defined as HIV viral load of <50 copies/ml measured at two consecutive visits PRIOR TO Week 48 and without subsequent rebound or change of ARV therapy prior to Week 48.|baseline to week 48|All treated patients. Early withdrawals were considered failures.||participants|||Number
750413|NCT00552279|Secondary|Number of Subjects Completing the 3-dose Vaccination Schedule||After the third vaccine dose|||subjects|||Number
750414|NCT00552279|Secondary|Number of Subjects With Pregnancies and Their Outcomes|"Entire study period = up to Month 18 Cervarix-12 & Month 12 Cervarix-6
Number of pregnancies and pregnancy outcomes."|During the entire study period (up to Month 18 or Month 12)|Analysis was performed on the Total vaccinated cohort, on pregnant subjects||subjects|||Number
750415|NCT00552279|Secondary|Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs), New Onset Autoimmune Diseases (NOADs), Serious Adverse Events (SAEs), and Medically Significant Conditions (MSCs)|"Entire study period = up to Month 18 Cervarix-12 & Month 12 Cervarix-6.
NOCDs assessed include eg. autoimmune disorders (NOADs), asthma, type I diabetes. MSCs assessed include AEs prompting emergency room visits and physician office visits not related to common illnesses.
An SAE is any untoward medical occurrence that: results in death, is lifethreatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above."|During the entire study period (up to Month 18 or up to Month 12)|||subjects|||Number
750416|NCT00552279|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|During the 30-day (Days 0-29) period following each vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.||subjects|||Number
750417|NCT00552279|Secondary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed include arthralgia, fatigue, fever, gastrointestinal symptoms, headache, myalgia, rash, and urticaria.|During the 7-day (Days 0-6) period following each vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.||subjects|||Number
750418|NCT00552279|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling at the injection site.|During the 7-day (Days 0-6) period following each vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.||subjects|||Number
750419|NCT00552279|Secondary|Titer of Anti-HPV-16 and Anti-HPV-18 Antibodies|Titer given as GMT.|One month after the second vaccine dose|Analysis was performed on initially seronegative subjects from the ATP cohort for analysis of immunogenicity||EL.U/mL||95% Confidence Interval|Geometric Mean
750420|NCT00552279|Secondary|Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies|"Seroconversion is defined as the appearance of anti-HPV-16 and/or anti- HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination.
Cut-off values were 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti- HPV-18 antibodies."|One month after the second vaccine dose|Analysis was performed on initially seronegative subjects from the ATP cohort for analysis of immunogenicity||subjects|||Number
750421|NCT00552279|Primary|Titer of Anti-HPV-16 and Anti-HPV-18 Antibodies|Titer given as geometric mean titer (GMT).|One month after the third vaccine dose|Analysis was performed on initially seronegative subjects from the ATP cohort for analysis of immunogenicity||EL.U/mL||95% Confidence Interval|Geometric Mean
750422|NCT00552279|Primary|Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies|"Seroconversion is defined as the appearance of anti-HPV-16 and/or anti- HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination.
Cut-off values were 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti- HPV-18 antibodies."|One month after the third vaccine dose|Analysis was performed on initially seronegative subjects from the According-to-Protocol (ATP) cohort for analysis of immunogenicity||subjects|||Number
750434|NCT00552396|Secondary|"Number of Evaluable Patients With Stable Disease. Evaluable is Defined as 2 Consecutive M Protein Assessments"|Disease Response Assessment by Principal Investigator and Sponsor(Efficacy Population).Stable Disease was defined as not meeting criteria for complete response, very good partial response, partial response, or progressive disease|From start of the treatment to end of study or disease progression|||Number of participants|||Number
750423|NCT00552305|Secondary|Percentage of at Least 50% Responders During the Treatment Period (up to 8 Years)|At least 50 percent response is based on the percentage reduction in 28-day seizure frequency during the Treatment Period of the open-label extension relative to the Baseline Phase of the prior study. This endpoint reflects the percentage of subjects with at least 50% reduction (ie, at least 50% change) in 28-day partial onset seizure frequency|Treatment Period (up to 8 years)|Of the 370 subjects who were enrolled/treated in the study, 369 are included in this summary based on the Full Analysis Set (FAS). FAS population: number of subjects treated with at least 1 post-baseline seizure diary day with available data during the SP615 study.||percentage of subjects|||Number
750424|NCT00552305|Secondary|Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (up to 8 Years)|"Median percentage change is the median value with respect to the percent change from Baseline across the population of subjects. Percentage change is calculated as 100 times the difference of the seizure frequency for the treatment period and the Baseline seizure frequency divided by the baseline seizure frequency.
Negative changes from Baseline indicate an improvement (i.e., a reduction) in 28-day seizure frequency."|Baseline, End of Treatment Period (up to 8 years)|Of the 370 subjects who were enrolled/treated in the study, 369 are included in this summary based on the Full Analysis Set (FAS). FAS population: number of subjects treated with at least 1 post-baseline seizure diary day with available data during the SP615 study.||percentage change||Full Range|Median
750425|NCT00552305|Primary|Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (up to 8 Years)|A serious adverse event is any untoward medical occurrences in a subject administered study treatment, whether or not the event is related to treatment, with at least one of the follow outcomes: death, life-threatening, initial inpatient hospitalization or prolongation of hospitalization, significant or persistent disability/incapacity, congenital anomaly/birth defect, or an important medical event that may jeopardize the subject and require a medical/surgical intervention.|During the Treatment Period (up to 8 years)|Of the 370 subjects who entered the study, 370 are included in this summary based on the Safety Set (SS). SS population: number of subjects treated.||subjects|||Number
750426|NCT00552305|Primary|Number of Subjects Prematurely Discontinuing Due to a Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (up to 8 Years)|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|During the Treatment Period (up to 8 years)|Of the 370 subjects who entered the study, 370 are included in this summary based on the Safety Set (SS). SS population: number of subjects treated.||subjects|||Number
750427|NCT00552305|Primary|Number of Subjects Reporting at Least 1 Treat-Emergent Adverse Event (TEAE) During the Treatment Period (up to 8 Years)|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|During the Treatment Period (up to 8 years)|Of the 370 subjects who entered the study, 370 are included in this summary based on the Safety Set (SS). SS population: number of subjects treated.||subjects|||Number
750428|NCT00552344|Secondary|Percentage of Subjects With Positive Anti-CZP Anti-body Status at Any Time From Week 0 of the Feeder Study C87085 to the Study Completion Visit in C87088|Subjects are counted as antibody positive to Certolizumab Pegol if they have at least one positive result from Week 0 in the previous study C87085 [NCT00552058] to the Last Visit in this study. A positive result is defined as Anti-CZP antibody levels > 2.4 units/mL.|From Week 0 of study C87085 [NCT00552058] to Study Completion Visit (Week 262) of C87088 (up to 268 weeks)|Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.||percentage of subjects|||Number
750429|NCT00552344|Secondary|Plasma Concentration of Certolizumab Pegol After 1 Year (Week 52)|Plasma samples for determination of Certolizumab Pegol were taken prior to Certolizumab Pegol administration.|Week 52|Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.||μg/mL||95% Confidence Interval|Geometric Mean
750430|NCT00552344|Secondary|Percentage of Subjects Achieving Inflamatory Bowel Disease Questionnaire (IBDQ) Remission (IBDQ ≥ 170) at Study Completion Visit (Week 262)|IBDQ remission is defined as having a total IBDQ score of 170 points or greater. IBDQ score consists of 32 questions eaching having a score of 1 to 7. Overall scores range from 32 to 224.|Week 262|Intention-to-Treat (ITT) population including all enrolled subjects irrespective of any protocol deviations who received at least 1 open-label injection of study treatment and who had at least 1 efficacy measurement after the first open-label injection.||percentage of subjects||95% Confidence Interval|Number
750431|NCT00552344|Secondary|Percentage of Subjects Achieving Harvey Bradshaw Index (HBI) Remission (HBI ≤ 4) at Study Completion Visit (Week 262)|HBI remission is defined as total HBI score of 4 points or less. HBI score consists of clinical parameters of general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (8 items, score 1 per item) lower scores indicating better well being. The first three parameters are scored for the previous day.|Week 262|Intention-to-Treat (ITT) population including all enrolled subjects irrespective of any protocol deviations who received at least 1 open-label injection of study treatment and who had at least 1 efficacy measurement after the first open-label injection.||percentage of subjects||95% Confidence Interval|Number
750432|NCT00552344|Primary|Percentage of Subjects With at Least One Serious Adverse Event (SAE) During the Duration of the Study C87088 (up to 272 Weeks)|An SAE is defined as any untoward medical occurrence that occurs at any dose which results in death, is life threatening, requires hospitalization, results in persistent/significant disability/incapacity, is an infection that requires parenteral antibiotics, is a congenital anomaly/birth defect, or is an important medical event.|From study start to the end of the Safety Follow-up Period (up to 272 weeks)|Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.||percentage of subjects|||Number
750433|NCT00552344|Primary|Percentage of Subjects With at Least One Adverse Event (AE) During the Duration of the Study C87088 (up to 272 Weeks)|An AE is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.|From study start to the end of the Safety Follow-up Period (up to 272 weeks)|Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.||percentage of subjects|||Number
752645|NCT00561600|Secondary|T-Test of Harris Hip Total Score Means at 24 Months|T-Test of Harris Hip total score means at 24 months|24 months|||Units on a scale of 0-100,100 is best.||Standard Deviation|Mean
750435|NCT00552396|Secondary|Area Under the Plasma-concentration-time Curve [AUC (INF)] of IPH2101 After Cycle 1 Administration|AUC(INF), area under the plasma concentration-time curve from zero to the last time of the last quantifiable concentration within the dosing interval was calculated for Cycle 1.|Anti-KIR (1-7F9) concentrations were measured prior to infusion at 0.167, 1, 3, 6, 12 and 24 hours and then on Days 7, 14 and 21 after the start of the first dose administration|||ng*hours/ml||Geometric Coefficient of Variation|Geometric Mean
750436|NCT00552396|Secondary|Maximum Plasma Concentration (Cmax) of IPH2101 After Cycle 1 Administration|Cmax was obtained from the plasma concentration versus time data after IV administration of IPH2101.|Anti-KIR (1-7F9) concentrations were measured prior to infusion at 0.167, 1, 3, 6, 12 and 24 hours and then on Days 7, 14 and 21 after the start of the first dose administration|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
750437|NCT00552396|Primary|Maximum Tolerated Dose (MTD) of IPH2101 as Determined by Number of Participants With Dose-Limiting Toxicities (DLTs) Related to IPH2101 Treatment|The maximum tolerated dose (MTD) is the highest dose level below the maximum administered dose (MAD) where none or 1 out of 6 subjects have a DLT.|From start of the treatment to end of study|All treated participants who received at least one dose of the study drug and were evaluable for DLT||Number of participants with DLT|||Number
750438|NCT00552409|Primary|Change in Urine Albumin Excretion|Albumin and creatinine concentrations were measured in 24hr urine collections at baseline, 3 months after randomization, and one year after randomization. We analyzed the difference in log-transformed albumin-creatinine ratio (ACR, mg/g) after randomization (3 months and one year, analyzed together with all available data included) compared with baseline, by treatment assignment. Results are transformed to present percent difference in urine ACR.|Baseline, 3 months, and one year|All participants were analyzed||percent difference||95% Confidence Interval|Mean
750439|NCT00552422|Primary|Symptomatic Improvement|The primary endpoint of the study is the achievement of a symptom grade of less then or equal to 3.|2 months|||participants|||Number
750440|NCT00552448|Secondary|Number of Participants With Chest Discomfort||During PICU admission|||participants|||Number
750441|NCT00552448|Secondary|Pediatric Asthma Severity Score (Modified Pulmonary Index Score)|Modified Pulmonary Index Score (MPIS): a validated asthma severity score in pediatric population (Carroll CL et al. A modified pulmonary index score with predictive value for pediatric asthma exacerbations, Ann Allergy Asthma Immunol 2005) Consists of: 1) oxygen saturation on room air 2) accessory muscle use 3) inspiratory to expiratory ratio 4) degree of wheezing 5) heart rate 6) respiratory rate Scored observations 0, 1, 2 or 3. Total score range 0 - 18. Mild exacerbation total less than 6, moderate exacerbation 6 – 10, severe exacerbation higher than 10|Discharge from PICU|Participants with available data||units on a scale||Full Range|Mean
750442|NCT00552448|Secondary|Total Days of Hospital Admission|This is limited due to non collection by collaborating centers.|Days|Data not collected|||||
750443|NCT00552448|Primary|Hours Spent in Pediatric ICU|Length of stay (hours) in Pediatric ICU.|Number of hours from admission to discharge from PICU|||Hours||Standard Deviation|Mean
750444|NCT00552513|Secondary|In-hospital Major Bleeding||Hospital discharge||||||
750445|NCT00552513|Secondary|Need for Mechanical or Pharmacological Coronary Revascularization (i.e. Thrombolysis, PCI, CABG) at Days 30, 90, and 180||180 days||||||
750446|NCT00552513|Secondary|Stroke at 30 Days and 180 Days||180 days||||||
750447|NCT00552513|Secondary|Composite of Death, MI, Stroke, Refractory Ischemia or Repeat Revascularization at 180 Days||180 days|||Eparticipants|||Number
750448|NCT00552513|Secondary|First Occurrence of Any Component of the Composite of Death, MI, or Refractory Ischemia||180 days|||participants|||Number
750449|NCT00552513|Primary|Composite of Death, Myocardial (re-) Infarction, or Stroke||180 days|All patients were included in the final intention-to-treat analysis. Event rates in the two groups were estimated with the use of the Kaplan–Meier method. The hazard ratio and two-sided 95% confidence intervals were calculated with the use of a Cox proportional-hazards model.||participants|||Number
750450|NCT00552578|Secondary|Treatment Retention.|"Treatment retention was defined as the completion of the buprenorphine dosing protocol (i.e., tapering doses vs. steady doses)."|Six months|Analysis was intent-to-treat.||Participants|||Number
750451|NCT00552578|Secondary|Number of Participants With Better Overall Quality of Life at Six Months as Compared to Baseline.|Qualitative measure (better/no change/worse) of participant's perception of overall quality of life related to assigned study protocol arm.|Baseline and six months|"Reported value (number) was the number who reported a better overall quality-of-life to the question: How would you describe your overall level of function now as compared to the time right before you started the study? Responses were recorded as: better, no change, or worse."||Participants|||Number
750452|NCT00552578|Primary|Relapse to Substance Abuse|Relapse to substance abuse (yes/no) was determined by participant self-report or by a positive urine toxicology.|Six months|||participants|||Number
750453|NCT00552669|Secondary|Target Vessel Revascularization (TVR)|Efficacy end point was TVR as revasacularization of the treated vessel.|18 months|We analyzed the number of vessels treated per group by ITT and the imputation technique was LOCF.||vessels|||Number
750454|NCT00552669|Secondary|Major Adverse Cardiovascular Events (MACCE)|Death from any cause, myocardial infarction and stroke. Safety was analyzed as MACCE (major adverse cardiovascular events) including death, MI and stroke.|18 Months|It was determinated by ITT and the technique used was LOCF.||participants|||Number
750455|NCT00552669|Primary|Differences in Costs Between Two Revascularization Strategies for de Novo Coronary Lesions.|Overall costs expressed in US dollars at 18 months of follow up between Oral Sirolimus Plus BMS vs DES implantation in denovo coronary lesions.|Follow up will be conducted by the coordinating Center at 18 months of follow up|All patients were analyzed for ITT and the imputation technique was LOCF||US dollars||Standard Deviation|Mean
750456|NCT00552695|Primary|Pain on Visual Analog Scale (VAS)|Pain on 100 mm Visual Aanalog Scale from 0 (no pain) to 100 (most pain).|0 MINUTES|||mm||Inter-Quartile Range|Median
750457|NCT00552695|Secondary|Success of Intravenous (IV) Insertion|Percentage of patients in whom intravenous catheter was inserted successfully|After first attempt of catheter insertion|||Percentage of participants|||Number
750473|NCT00553098|Secondary|Greater Than 50% CD19+ Donor Chimerisms at 1 Year Post Transplant|Number of Patients Who Achieve Greater Than 50% CD19+ Donor Chimerisms at 1 Year Post Transplant|1 year|Excludes 9 patients who expired prior to 1 year time point||Participants|||Count of Participants
750458|NCT00552760|Secondary|Cumulative Proportion of Participants in Each Arm Surviving Without Relapse|Survival analysis techniques, including Kaplan Meier curves, were used to evaluate group differences in time to relapse. Relapse was defined as a medication initiation or change for manic/depressed/mixed symptoms, a hospitalization for manic/depressed/mixed symptoms, MADRS score >= 16, YMRS score > 14, and suicide risk or imminent risk of suicide. Time to relapse was measured discretely in terms of the number of assessment visits until discontinued from the study.|Monthly for 6 months|Intent to Treat Analysis; excludes 7 screen failures.||Cumulative proportion of participants|||Number
750459|NCT00552760|Secondary|Clinical Global Impressions Bipolar Version(CGI-BP) Severity of Illness Overall Score|3-part (mania, depression, overall bipolar illness), physician-administered scale used to assess global illness severity; used to measure change. Each part is rated from 1-7, higher scores represent more severe mental illness. Only overall bipolar rating was used.|Monthly for 6 months|Intent to Treat Analysis; excludes 7 screen failures||units on scale||Standard Error|Mean
750460|NCT00552760|Secondary|Young Mania Rating Scale (YMRS) Total Score|11-item standardized, well-validated scale used to measure manic symptoms; sensitive to treatment effects in manic patients. Scores range from 0-60, higher scores represent more severe manic symptoms.|Monthly for 6 months|Intent to Treat Analysis; excludes 7 screen failures||units on scale||Standard Error|Mean
750461|NCT00552760|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|10-item, standardized, well-validated scale used to measure severity of depressive symptoms; sensitive to treatment effects in depressed outpatients. Scores range from 0-60, higher scores represent more severe depressive symptoms.|Monthly for 6 months|Intent to Treat Analysis; excludes 7 screen failures||units on scale||Standard Error|Mean
750462|NCT00552760|Primary|Pittsburgh Sleep Quality Index (PSQI) Global Score|Self-rated scale to measure quality of sleep via questions regarding sleep latency, duration, efficiency, disturbances, use of sleep medication, and daytime dysfunction. Scores range from 0-21, higher scores represent more significant sleep disturbance.|Monthly for 6 months|Intent to Treat Analysis; excludes 7 screen failures.||units on scale||Standard Error|Mean
750463|NCT00552786|Secondary|Temporary Threshold Changes Measurement by Distortion Product Otoacoustic Emissions (DPOAE) (A Total of Four Hearing Assessments Were Completed for Each Formulation Period on the 1st Day Pre- and Post-shift, and the 14th Day Pre- and Post-shift)|Distortion product otoacoustic emissions (DPOAE) is an objective measure to assess the cochlear changes. DPOAE response threshold at high frequency (HF) was defined as the average of response levels (dB SPL) at 3k,4k,6kHz for each ear examined. A total of four hearing assessments by DPOAE were completed for each formulation period on the 1st day pre- and post-shift, and the 14th day pre- and post-shift. The amount of DPOAE temporary threshold change was calculated by subtracting the pre-shift DPOAE response threshold from the post-shift DPOAE response threshold at each frequency.|A total of four hearing assessments were completed for each formulation period on the 1st day pre- and post-shift, and the 14th day pre- and post-shift|Intent to treat analysis including only participants who had all 4 post-baseline assessments (measurements at beginning of 1st and 2nd intervention periods and end of 1st and 2nd intervention periods).||decibels (dB SPL)||Standard Deviation|Mean
750464|NCT00552786|Primary|Temporary Threshold Shift Measurement by Pure Tone Audiometry (A Total of Four Hearing Assessments Were Completed for Each Formulation Period on the 1st Day Pre- and Post-shift, and the 14th Day Pre- and Post-shift)|The hearing threshold level (HL) at high frequency (HF) by pure-tone audiometry (PTA) was defined as the average of HLs at 3k,4k,6kHz for each ear examined. A total of four hearing assessments by PTA were completed for each formulation period on the 1st day pre- and post-shift, and the 14th day pre- and post-shift. The amount of temporary threshold change was calculated by subtracting the pre-shift hearing threshold from the post-shift hearing threshold at each frequency.|A total of four hearing assessments were completed for each formulation period on the 1st day pre- and post-shift, and the 14th day pre- and post-shift|Intent to treat analysis including only participants who had at least one post-baseline assessment.||decibels||Standard Deviation|Mean
750465|NCT00552812|Secondary|Systolic Blood Pressure, Difference Between Upper and Lower Extremities|Measurement of difference between upper and lower extremities by noninvasive, automated measurement of four quadrant Systolic Blood Pressure. Comparison between baseline and 12 month follow up.|Baseline and 12 months|Comparison between baseline(n=105) and 12 month follow up (n=92)||mmHg||Standard Deviation|Mean
750466|NCT00552812|Secondary|Percentage of Participants With a Systolic Blood Pressure Greater Than the 95th Percentile for Age and Gender 12 Months Post Stent Placement|Noninvasive Blood pressure is assessed at baseline and 12 months. The number of patients with a Systolic Blood Pressure > 95th Percentile for Age and Gender is recorded at Baseline (n=105) and compared to 12 month follow up (n=92).|Baseline and 12 months|Study patients compared at baseline and within the 12 month follow up window: Baseline (n=105) compared to 12 month follow up (n=92)||percentage of participants|||Number
750467|NCT00552812|Primary|Change in Difference Between Arm and Leg Systolic Blood Pressure From Baseline to 12 Months|Noninvasive systolic blood pressures are measured in the arms and legs at baseline and 12 month follow-up. The difference between these measurements are calculated. The difference between systolic arm and leg blood pressures decreased by 30 ± 22 mmHg (n=90)|12 months|||mmHg||Standard Deviation|Mean
750468|NCT00553098|Secondary|Number of Patients Diagnosed With Chronic GVHD|Number of patients diagnosed with chronic GVHD within 1 year post transplant|1 year|Excludes 6 patients who expired prior to Day 100||Participants|||Count of Participants
750469|NCT00553098|Secondary|Number of Patients Diagnosed With Overall Grade III or Grade IV Acute GVHD|Number of patients diagnosed with overall Grade III or Grade IV Acute GVHD by Day 100 post transplant|Day 100|Excludes 10 patients who were not diagnosed with acute GVHD||Participants|||Count of Participants
750470|NCT00553098|Secondary|Number of Patients Diagnosed With Overall Grade 1 or Grade 2 Acute GVHD|Number of patients diagnosed with overall grade I or grade II acute GVHD by Day 100 post transplant|Day 100|Excludes 10 patients who were not diagnosed with acute GVHD||Participants|||Count of Participants
750471|NCT00553098|Secondary|Number of Patients Diagnosed With Acute GVHD|Number of patients diagnosed with acute GVHD by Day 100 post transplant|Day 100|||Participants|||Count of Participants
750472|NCT00553098|Secondary|Clinical Significant Infection, Requiring Treatment, Within 100 Days Post Transplant|Number of patients who experienced a clinical significant infection, requiring treatment, within 100 days post transplant.|100 days|||Participants|||Count of Participants
750478|NCT00553098|Primary|Number of Patients Who Achieve Greater Than 50% Donor T-cell Chimerism|The study will be considered a success and the protocol worthy of further study if there is sufficient evidence that this rate is greater than the 50% rate observed in the most recently transplanted patients with nonmalignant disorders. Analyses will be carried out separately for the alemtuzumab recipients and the TBI recipients. We will be 80% confidence of success if a one-sided 80% confidence interval for the proportion of patients with successful chimerism exceeds 50%. Cumulative incidence will be used to evaluate the probability of chimerism.|At 1 year post transplant|Excludes 9 patients who expired prior to 1 year||Participants|||Count of Participants
750479|NCT00553150|Secondary|Overall Survival Time|Overall survival: The overall survival or survival time is defined as the time from registration to death due to any cause. The distribution of overall survival will be estimated using the method of Kaplan-Meier method.|Up to 15 years|||months||95% Confidence Interval|Median
750480|NCT00553150|Secondary|Progression-free-survival at 6 Months (Phase II)|Progression-free-survival at 6 months: is the proportion of patients alive and progression-free at 6 months after start of regimen. This proportion will be estimated using the binomial point estimator and the binomial 95% confidence interval estimated. Progression is defined as at least a 25% increase in product of perpendicular diameters of contrast enhancement or mass or unequivocal increase in size of contrast enhancement or increase in mass effect as agreed upon independently by primary physician and quality control physicians or appearance of new lesions.|at 6 months|||proportion of participants||95% Confidence Interval|Number
750481|NCT00553150|Secondary|Time to Progression (Phase II)|Time-to-disease progression is defined as the time from start of study therapy to documentation of disease progression. Patients who die without documentation of progression will be considered to have had tumor progression at the time of death unless there is documented evidence that no progression occurred before death. Patients who fail to return for evaluation after beginning therapy will be censored for progression on the last day of therapy. Patients who experience major treatment violations will be censored for progression on the date of treatment violation occurred. The time-to-progression distribution will be estimated using the Kaplan-Meier method. Progression is defined as at least a 25% increase in product of perpendicular diameters of contrast enhancement or mass or unequivocal increase in size of contrast enhancement or increase in mass effect as agreed upon independently by primary physician and quality control physicians or appearance of new lesions.|Up to 5 years|||months||95% Confidence Interval|Median
750482|NCT00553150|Secondary|Response Rate, as Measured in Patients Receiving FLT-PET Imaging (Phase II)|The response rate is defined as the percentage of patients receiving F-fluorothymidine positron emission tomography (FLT-PET) imaging whose cancer shrinks or disappears after treatment. A reduction in standardized uptake value (SUV) of 30% or greater in the T1-post-gadolinium scan volume of interest (T1-gad VOI) or the total tumor VOI will be considered a responsive tumor.|Up to 5 years|Of the 11 patients with measurable residual disease and pre-everolimus FLT-PET imaging, 2 did not have a second FLT-PET scan performed due to technical difficulties with FLT production, leaving 9 patients who could be assessed for changes in FLT uptake.||percentage of participants||95% Confidence Interval|Number
750483|NCT00553150|Primary|Overall Survival at 12 Months (Phase II)|"The primary endpoint is overall survival at 12 months (OS12) after entry into this study. The proportion of successes will be estimated using the binomial point estimator (number of successes divided by the total number of evaluable patients) and the binomial 95% confidence interval estimated. A patient who is evaluable and survive more than 12 months (i.e. 365 days or more) after start of therapy will be classified as a “success”. Patients who die within 12 months after start of therapy will be considered to have failed”."|at 12 months|||proportion of participants||95% Confidence Interval|Number
750484|NCT00553150|Primary|Maximum Tolerated Dose (MTD) of Everolimus (RAD001) in Combination With Temozolomide (TMZ) and 3D-conformal Radiotherapy (RT) or Intensity-modulated Radiotherapy (IMRT) Followed by Adjuvant TMZ With or Without RAD001 (Phase I)|Patients were assessed during RT for dose-limiting toxicities (DLT), which were defined as failure to deliver greater than 75% of the planned doses of TMZ or RAD001 during RT, interruption of RT for more than 5 days because of toxicity, or the following: >= Grade 3 diarrhea or skin rash; >= Grade 4 neutropenia, leukopenia, or thrombocytopenia; >= Grade 4 hypertriglyceridemia, hypercholesterolemia, or hyperglycemia despite optimal medial management, other >= 3 non-hematologic events; or >= Grade 4 radiation dermatitis. Maximum tolerated dose (MTD) was defined a priori as the highest dose level at which 0 or 1 of 6 patients developed DLTs. The number of patients who developed DLTs are reported here by dose level, with the MTD reported in the statistical analysis section.|Up to 49 days|Eighteen patients were enrolled in Phase I of the study to determine the maximum tolerated dose (MTD). The dosage of RAD001 was escalated in cohorts of 6 patients.||participants who developed DLTs|||Number
750485|NCT00553202|Other Pre-specified|Time to the Donor-specific NK-cell Receptor Expression|The presence of donor cells is demonstrated by the detection of informative variable-number tandem-repeat polymorphisms or by fluorescent in situ hybridization with a Y-chromosome-specific probe in cases of sex-mismatched transplants. Independent variables that will be examined include donor-recipient KIR mismatch, taking into consideration the interactions with donor-recipient human leukocyte antigen (HLA) compatibility, and the numbers of CD34+ cells and CD3+ cells in the graft.|Up to 42 days after SCT||||||
750486|NCT00553202|Other Pre-specified|Acute and Chronic Graft-versus-host Disease|Acute and chronic GVHD will be summarized.|Up to 5 years||||||
750487|NCT00553202|Other Pre-specified|Disease-free Survival|The cumulative incidence of relapse or death after SCT will be calculated by considering relapse and death due to other causes as competing events.|From the date of SCT to the date of relapse, the date of death, or the date of last follow-up, whichever occurs first||||||
750488|NCT00553202|Primary|Cumulative Incidence of NK Cell Reconstitution|Cumulative incidence of successful reconstitution to donor level is calculated.|At 5 years from HSCT date|Patients without completion of planned therapy (n=68) or without NK cell status (n=38) are excluded from analyses of TExp||Percentage of participants||95% Confidence Interval|Number
750489|NCT00553202|Primary|Overall Survival (OS)|OS - Time from HSCT until death|At 5 years from HSCT date|Patients without completion of planned therapy (n=68) are excluded from analyses of OS||Percentage of participants||95% Confidence Interval|Number
750490|NCT00553267|Secondary|Peripheral Oedema Incidence Rate|The number of cases of peripheral oedema (expressed as number of cases/100 patient-years)|During randomised treatment period|||Number of cases/100 patient-years|||Number
750491|NCT00553267|Secondary|Oedema Incidence Rate|The number of patients who experienced at least one case of oedema or worsening of oedema for the first time (expressed as number of patients/100 patient-years)|During randomised treatment period|Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward||Number of patients/100 patient-years|||Number
750492|NCT00553267|Secondary|Trough Seated BP Normality Classes|The number of patients who reach predefined BP categories|End of study (8 weeks or last value on treatment)|Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward||Participants|||Number
750493|NCT00553267|Secondary|Trough Seated SBP Response|The number of patients who reach the target SBP of <140mmHg or had a reduction in SBP >= 15 mmHg|End of study (8 weeks or last value on treatment)|Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward||Participants|||Number
750494|NCT00553267|Secondary|Trough Seated SBP Control|The number of patients who reach the target SBP of <140mmHg|End of study (8 weeks or last value on treatment)|Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward||Participants|||Number
750495|NCT00553267|Secondary|Trough Seated DBP Response|The number of patients who reach the target DBP of <90mmHg or had a reduction in DBP >= 10mmHg|End of study (8 weeks or last value on treatment)|Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward||Participants|||Number
750496|NCT00553267|Secondary|Trough Seated Diastolic Blood Pressure <80 mmHg|The number of patients who reach the target DBP of <80mmHg|End of study (8 weeks or last value on treatment)|Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward||Participants|||Number
750497|NCT00553267|Secondary|Trough Seated Diastolic Blood Pressure Control (Defined as < 90mmHg)|The number of patients who reach the target DBP of <90mmHg|End of study (8 weeks or last value on treatment)|Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward||Participants|||Number
750498|NCT00553267|Secondary|Change From Baseline in Trough Seated Systolic Blood Pressure|Change from baseline to the end of study in trough SBP|Baseline and end of study (8 weeks or last value on treatment)|Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward||mmHg||Standard Error|Least Squares Mean
750499|NCT00553267|Primary|Change From Baseline in Trough Seated Diastolic Blood Pressure|Change from baseline to the end of study in trough DBP|Baseline and end of study (8 weeks or last value on treatment)|Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward||mmHg||Standard Error|Least Squares Mean
750500|NCT00553280|Secondary|Change From Baseline in Short-Form McGill Pain Questionnaire: Present Pain Intensity Scores|The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Present pain intensity score ranges from 0-5. Higher scores indicate more severe pain.|From baseline to 52 weeks or study discontinuation (Study Endpoint)|Full analysis set. No imputations for missing data.||score on scale||Standard Deviation|Mean
750501|NCT00553280|Secondary|Change From Baseline in Short-Form McGill Pain Questionnaire: Visual Analogue Scale Scores|The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Visual Analogue Scale Score ranges from 0-100 mm. Higher scores indicate more severe pain.|From baseline to 52 weeks or study discontinuation (Study Endpoint)|Full analysis set. No imputations for missing data.||mm||Standard Deviation|Mean
750502|NCT00553280|Secondary|Change From Baseline in Short-Form McGill Pain Questionnaire: Total Scores|The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Total score ranges from 0-45. Higher scores indicate more severe pain.|From baseline to 52 weeks or study discontinuation (Study Endpoint)|Full analysis set. No imputations for missing data.||score on scale||Standard Deviation|Mean
750503|NCT00553280|Secondary|Change From Baseline in Short-Form McGill Pain Questionnaire: Affective Scores|The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Affective score ranges from 0-12. Higher scores indicate more severe pain.|From baseline to 52 weeks or study discontinuation (Study Endpoint)|Full analysis set. No imputations for missing data.||score on scale||Standard Deviation|Mean
750504|NCT00553280|Secondary|Change From Baseline in Short-Form McGill Pain Questionnaire: Sensory Scores|The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Sensory score ranges from 0-33. Higher scores indicate more severe pain.|From baseline to 52 weeks or study discontinuation (Study Endpoint)|Full analysis set. No imputations for missing data.||score on scale||Standard Deviation|Mean
750505|NCT00553280|Primary|Summary of Adverse Events|Number of participants with all causality adverse events, serious adverse events, severe adverse events, adverse events resulted in discontinuation, dose reduced or temporary discontinuation. Participants are counted only once per treatment in each row.|53 weeks|Safety analysis set: all participants who had received at least one dose of the study drug.||participants|||Number
750506|NCT00553319|Primary|ADHD Symptoms Based on ADHD Rating Scale|The proportion of subjects exhibiting >30% reduction of AISRS score at last enrollment week compared to week 0|measured once per week for 14 weeks or length of study participation|||participants|||Number
750507|NCT00553319|Primary|Last Three Weeks of Cocaine Abstinence Based on Urine Toxicology Results and Self Reported Use|Each week after randomization was scored dichotomously as cocaine positive or negative. Cocaine use was positive if any urine or self-report was positive. Cocaine use was negative if all urines (BE <300 ng/ml) and all self-report were negative. Weeks with no urine or no self-report were designated missing.|weekly for 14 weeks of trial or for length of participation|||percentage of participants|||Number
750508|NCT00553332|Secondary|Protein Levels of RAS/RAF/MEK/ERK Signaling Pathway Activation|Measure the proteins levels of RAS/RAF/MEK/ERK signaling pathway activation to AZD6244|At baseline|Only 27 patients had pAKT and pERK performed due to 2 samples not available for analysis||mg/ml||Standard Deviation|Mean
750513|NCT00553332|Primary|Objective Response Rate (CR and PR)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Every 8 weeks|||patients|||Number
750514|NCT00553358|Secondary|Number of Circulating Tumor Cells (CTC) in the Bloodstream|Circulating tumor cells (CTCs) are cells that have detached from a primary tumor and circulate in the bloodstream. In the adjuvant phase, after surgery all participants received 3 courses of adjuvant 5-fluorouracil, epirubicin and cyclophosphamide, followed by lapatinib 1500 mg or trastuzumab 2 mg/kg or lapatinib 1000/750 mg plus trastuzumab 2 mg/kg given prior to surgery in the neoadjuvant setting for an additional 34 weeks. Data for this outcome measure cannot be presented at this time as they have yet to be evaluated and reviewed.|Baseline, Week 2 of neo-adjuvant phase (Weeks 1-34), at surgery (Weeks 20 to 22), Week 10 of adjuvant phase, 6 months after completion of adjuvant treatment, and at recurrence||08/2021||||
750515|NCT00553358|Secondary|Number of Participants With the Indicated Biomarker Expression|Biomarker levels (Ki67, p27, Cyclin-D1, ErbB1, ErbB2, ErbB3, pErbB1, pErbB2, Akt and pAkt, S6 and pS6, MAPK and pMAPK, c-myc, IGFR1, p95HER2, PTEN, ER (alpha, beta), PgR,CD34, terminal deoxynucleotidyl transferase biotin-dUTP nick and labelling technique [TUNEL] and topoisomerase II) were assessed in participants. Blood and tumor tissue samples were collected at Baseline and at Weeks 2 and 20-22; however, data for this outcome measure cannot be presented at this time as they have yet to be evaluated and reviewed.|Baseline, Week 2, and at surgery (Weeks 20 to 22)||08/2021||||
750516|NCT00553358|Secondary|Number of Participants With Metabolic Response of Complete Response (mCR), Partial Response (mPR), or Stable Disease (mSD) as Determined by Positron Emission Tomography/Computed Tomography (PET/CT)|European Organisation for Research and Treatment of Cancer recommendations were used to define metabolic response. mCR, complete metabolic response: complete resolution of fludeoxyglucose uptake within tumor, indistinguishable from surrounding normal tissue. mPR, partial metabolic response: reduction of more than 25% of maximum tumor standard uptake value (SUV). mSD, stable metabolic disease: increase of <25% in tumor SUV or decrease of >20% in tumor SUV. mPD, progressive metabolic disease: increase of >25% in tumor SUV or >20% in the extent (longest dimension) or appearance of new metastases.|Baseline, Week 2, and Week 6||08/2021||||
750517|NCT00553358|Secondary|Disease-free Survival (DFS)|DFS was defined as the time from surgery to the first date of breast cancer relapse, second primary tumor (including contralateral breast cancer), or death without documented prior relapse. Data will be reported when they are mature and available, likely when a median of 3 years follow up has been reached.|Following surgery, every 12 months until Year 10||01/2019||||
750518|NCT00553358|Secondary|Overall Survival|Overall survival was defined as the period from surgery until death (from any cause). Data will be reported when they are mature and available; OS is assessed annually for up to 10 years after the randomization of the last participant into the study.|Following surgery, every 12 months until Year 10||01/2020||||
750519|NCT00553358|Secondary|Number of Participants Starting Paclitaxel Before Completing 6 Weeks of Treatment With Either Lapatinib or Trastuzumab|Participants with progressive disease at 4 week assessment that were permitted to commence treatment with paclitaxel.|Week 6|ITT Population. Participants who did not start any treatment were excluded from analysis.||participants|||Number
750520|NCT00553358|Secondary|Estimate of Treatment Contrast for Change From Baseline in Tumor Size at Week 6 and at Surgery|Estimate of treatment contrast is defined as the estimate of the difference between treatment groups in the change from baseline in tumor size. Change from baseline in tumor size was defined as tumor size at Week 6/ surgery (Weeks 20 to 22) minus tumor size at baseline. The difference in treatment arms was estimated for Lapatinib 1500 mg versus Trastuzumab 2 mg/kg and for Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg versus Trastuzumab 2 mg/kg.|Week 6 and surgery (Weeks 20 to 22)|ITT Population||millimeters||Standard Deviation|Mean
750521|NCT00553358|Secondary|Number of Participants With Actual Indicated Surgery|Participants were assessed for the type of surgery they underwent for breast cancer. Non-conservative surgery is defined as a radical or modified radical mastectomy. Conservative surgery is comprised of a lumpectomy, a quadrantectomy/segmentectomy, or a partial mastectomy. Participants who were not assessed as being candidates for non-conservative or conservative surgery were classified as non-operable.|At surgery (Weeks 20 to 22)|ITT Population||participants|||Number
750522|NCT00553358|Secondary|Number of Participants With Negative Lymph Nodes at the Time of Surgery|Participants were assessed for node-negative lymph nodes at the time of surgery. As per the pathological TNM (Tumor, Node, Metastases) classification (pTNM) of malignant tumors: pN, absence or presence and extent of regional lymph node metastasis. Node-negative (pN0) participants had no regional lymph node metastasis. Although not assessed in this measure, pT is the extent of primary tumor, and pM is the absence or presence of distant metastasis.|Time of surgery (Weeks 20 to 22)|ITT Population. Participants with a lymph node status of pNX (i.e., regional lymph nodes cannot be assessed) were omitted from the analysis of node-negative participants.||participants|||Number
750523|NCT00553358|Secondary|Number of Participants With Overall Response at the Time of Surgery|The number of participants with overall response (complete response and/or partial response) was evaluated using WHO criteria by clinical examination and mammography and breast echography with bi-dimensional measurements at the time of surgery (Weeks 20 to 22). As per WHO criteria: complete response is defined as the disappearance of all lesions; partial response is defined as a greater than 50% decrease in the sum of products of the greatest length and width of the largest lesion; progressive disease is defined as a greater than 25% increase in the sum of products of all measurable lesions.|Time of surgery (Weeks 20 to 22)|ITT Population||participants|||Number
750524|NCT00553358|Secondary|Number of Participants With Overall Response at Week 6|The number of participants with overall response (complete response and/or partial response) was evaluated using World Health Organization (WHO) criteria by clinical examination and by mammography and breast echography with bi-dimensional measurements at Week 6. As per WHO criteria: complete response is defined as the disappearance of all lesions; partial response is defined as a greater than 50% decrease in the sum of products of the greatest length and width of the largest lesion; progressive disease is defined as a greater than 25% increase in the sum of products of all measurable lesions.|Week 6|ITT Population||participants|||Number
753202|NCT00566995|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|72 months and 14 days|||participants|||Number
750525|NCT00553358|Primary|Number of Participants With Pathological Complete Response (pCR) at the Time of Surgery|Pathological complete response is defined as no invasive cancer in the breast or only non-invasive in situ cancer in the breast specimen. Surgical breast and axillary node resection specimens were evaluated for pathologic tumor response according to National Surgical Adjuvant Breast and Bowel Project (NSABP) guidelines, which do not take into account the histological nodal status.|Weeks 20 to 22|Intent-to-Treat (ITT) Population: all participants randomized to treatment, except for those who withdrew their consent to use any of their data (permitted by law in certain countries) prior to receiving any study medication||participants|||Number
750526|NCT00545740|Secondary|Percent of Subjects Requiring Surgery for Diverticulitis||Up to 104 weeks|Full Analysis Set consists of all subjects who were randomized and took at least 1 dose of investigational product.||percentage of subjects|||Number
750527|NCT00545740|Secondary|Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Negative|A negative CT scan was defined as a CT scan that did not show bowel wall thickening (>5 mm) and/or fat stranding as read by the central reader.|Up to 104 weeks|Suspected Recurrence of Diverticulitis consists of subjects in the Full Analysis Set who had a CT scan performed. Since subjects may have had more than one suspected recurrence, counts are of the number of CT scans, not the number of subjects.||Number of CT scans|||Number
750528|NCT00545740|Secondary|Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Positive|A positive CT scan was defined as a CT scan that showed bowel wall thickening (>5 mm) and/or fat stranding as read by the central reader.|Up to 104 weeks|Suspected Recurrence of Diverticulitis consists of subjects in the Full Analysis Set who had a CT scan performed. Since subjects may have had more than one suspected recurrence, counts are of the number of CT scans, not the number of subjects.||Number of CT scans|||Number
750529|NCT00545740|Secondary|Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Negative|A negative CT scan was defined as a CT scan that did not show bowel wall thickening (>5 mm) and/or fat stranding as read by the central reader.|Up to 104 weeks|Suspected Recurrence of Diverticulitis consists of subjects in the Full Analysis Set who had a CT scan performed. Since subjects may have had more than one suspected recurrence, counts are of the number of CT scans, not the number of subjects.||Number of CT scans|||Number
750530|NCT00545740|Primary|Percent of Subjects Without Recurrence of Diverticulitis|Recurrence of diverticulitis is defined as the presence of each and all of the following 3 items: 1) abdominal pain, 2) a 15% increase in white blood cell count from baseline, 3) bowel wall thickening (>5 mm) and/or fat stranding as evidenced by spiral computerized axial tomography (CT) scan; OR surgical intervention for diverticular disease. Withdrawals are considered as recurrences.|Up to 104 weeks|Full Analysis Set (FAS) consists of all subjects who were randomized and took at least 1 dose of investigational product.||percentage of subjects|||Number
750531|NCT00545740|Secondary|Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Positive|A positive CT scan was defined as a CT scan that showed bowel wall thickening (>5 mm) and/or fat stranding as read by the central reader.|Up to 104 weeks|Suspected Recurrence of Diverticulitis consists of subjects in the Full Analysis Set who had a CT scan performed. Since subjects may have had more than one suspected recurrence, counts are of the number of CT scans, not the number of subjects.||Number of CT scans|||Number
750532|NCT00545740|Secondary|Percent of Subjects Who Were CT-Recurrence Free of Diverticulitis|CT-recurrence of diverticulitis is defined as: a positive spiral CT scan for diverticulitis showing, at a minimum, fat stranding with or without bowel wall thickening >5 mm or surgical intervention for diverticular disease. Withdrawals considered as CT-recurrences.|Up to 104 weeks|Full Analysis Set (FAS) consists of all subjects who were randomized and took at least 1 dose of investigational product.||percentage of subjects|||Number
750533|NCT00545753|Secondary|Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions.|To evaluate the safety of NatrOVA® 1% Creme Rinse based upon reported adverse events and observed skin/scalp reactions. Additional safety assessments included cutaneous/ocular irritation.|Participants were followed for a minimum of 14 days (1 treatment) and a maximum of 21 days (2 treatments)|558 subjects were randomized to treatment and 540 subjects used the study drug and returned for at least one post-baseline evaluation. At Day 0 the study drug was to be used within 24 hours. At Day 7 if subject presented with live lice they were provided a second treatment to be used within 24 hours. Thus subjects used 1 or 2 treatments.||Incidents|||Number
750534|NCT00545753|Primary|Efficacy of NatrOVA Creme Rinse - 1% Relative to NIX Creme Rinse in Subjects Infested With Head Lice|The primary efficacy endpoint was the proportion of primary subjects in the enrolled households who were lice free (no live lice, adults or nymphs), as assessed by the trained evaluator, 14 days after the last treatment (i.e., Day 14 for subjects who treated once and Day 21 for subjects who treated twice).|Assessment were made 14 days following the final product treatment|Primary efficacy analysis was conducted using the Intent to Treat data obtained from primary subjects (i.e., youngest enrolled members of each household who had at least three live lice at the time of entry into the study). Subjects who were lice free 14 days post-treatment were considered successes and all other subjects were considered failures.||participants|||Number
750535|NCT00545766|Secondary|Time to PSA Progression and Overall Survival Will be Summarized Via Kaplan-Meier-type Plots, and by Medians With Corresponding 95% Confidence Interval (CI).||18 months||||||
750536|NCT00545766|Primary|Protein-specific Antigen (PSA) Response Rate|Defined as the percentage of patients with an objective decrease in PSA and/or experience an objective benefit from treatment.|18 months|||percentage of patients||95% Confidence Interval|Number
750537|NCT00545779|Secondary|Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) Domain Scores in Part B|The OPSAT-Q is a validated questionnaire designed to capture satisfaction with bisphosphonate treatment. It comprises four domains: convenience (questions 1–6), quality of life (questions 7 and 8), overall satisfaction (questions 9 and 10), and side effects (questions 11–16). Each domain (scale) ranges 0-100 scale. All items were scored such that higher scores represented greater satisfaction or less bother. Treatment satisfaction was measured with the OPSAT-Q composite satisfaction score (OPSAT-Q CSS), which was the average of the scores from the four domains of the OPSAT-Q converted to a 0–100-point scale, in which higher scores indicate greater satisfaction.|Baseline, Month 6|The ITT population included all participants who received at least one dose of study medication.||units on a scale||Standard Deviation|Mean
750542|NCT00545779|Secondary|Percentage of Participants Who Reported an Improved Satisfaction Score After 6 Months in Part B|"Percentage of participants who report an improved satisfaction score after 6 months of monthly ibandronate therapy as compared to daily or weekly alendronate or risendronate at baseline based on responses to each individual question in the CIQ were reported. In the CIQ participants were asked to answer either 'yes' or 'no' to the following 3 questions:
I would prefer a monthly oral dosing schedule to my current (daily or weekly) dosing schedule
More than once per month, I have experienced stomach upset within 48 hours of taking my osteoporosis medication
Over the past 3 months, I have missed taking 3 or more doses of my current (daily or weekly) osteoporosis medication"|Month 6|The ITT population included all participants who received at least one dose of study medication.||percentage of participants|||Number
750543|NCT00545779|Secondary|Percentage of Participants Eligible Current Daily or Weekly Bisphosphonate Users at Screening Who Elect to Enter Part B by CIQ||Visit 0 (<= Day -30)|The ITT population included all participants who received at least one dose of study medication.||percentage of participants|||Number
750544|NCT00545779|Primary|Percentage of Participants With Positive Change in Total Composite Satisfaction Score (CSS) at Month 6 in Part B by CIQ Fracture (Fr) Group|Participants with a positive change from their baseline CSS at Month 6 are considered those participants who are satisfied with once-monthly dosing of ibandronate after 6 months of use were reported. The CSS is scaled from 0 to 100 and is an average of the 4 domain scores of the Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q): Convenience (questions 1 to 6), Quality of Life (questions 7 and 8), Overall Satisfaction (questions 9 and 10) and Side Effects (questions 11 to 16). Higher scores indicating greater satisfaction.|Month 6|The intent-to treat (ITT) population included all participants who received at least one dose of study medication. Number of participant analyzed are with or without previous history of Fr.||percentage of participants|||Number
750545|NCT00545779|Primary|Percentage of Participants Who Reported Preference for Monthly Ibandronate|Percentage of participants who reported preference for monthly ibandronate were reported.|Visit 0 (<= Day -30)|All enrolled participants who completed the part A of the study.||percentage of participants|||Number
750546|NCT00545779|Primary|Percentage of Participants Current Daily or Weekly Bisphosphonate Users in Part A Who Answer ‘Yes’ to Any of the Questions in the Candidate Identification Questionnaire (CIQ)|"The CIQ was completed in Part A by all the participants. The information from the CIQ was used to determine the percentage of current daily or weekly bisphosphonate users for whom monthly ibandronate represented a potentially more satisfactory therapeutic option.
In the CIQ participants were asked to answer either ‘yes’ or ‘no’ to the following 3 questions:
I would prefer a monthly oral dosing schedule to my current (daily or weekly) dosing schedule.
More than once per month, I have experienced stomach upset within 48 hours of taking my osteoporosis medication.
Over the past 3 months, I have missed taking 3 or more doses of my current (daily or weekly) osteoporosis medication."|Visit 0 (less than or equal to [<=] Day -30)|All enrolled participants who completed the part A of the study.||percentage of participants|||Number
750547|NCT00545792|Secondary|Single Point Estimate of 1-year Progression-free Survival of Patients Treated With Concurrent Avastin and Daily Pelvic Radiation With no Other Concurrent Chemotherapy|Progression free survival was calculated from the date of diagnosis to the date of disease progression as detected by clinical examination or imaging.|1-year|20 patients received and completed treatment.||participants|||Number
750548|NCT00545792|Primary|Toxicity Rates of Patients Treated With Concurrent Avastin and Daily Pelvic Radiation With no Other Concurrent Chemotherapy|Toxicity was the cumulative number of events, all grades and categories, related to side effects from avastin and radiation including, but not limited to, bowel, bladder, skin, gynecologic and other morbidity.|1-year|20 patients received and completed treatment.||Events|||Number
753673|NCT00577824|Secondary|Change in Total Cholesterol|Change in total cholesterol from baseline to endpoint (i.e., total cholesterol at week 24 minus total cholesterol at week 0)|baseline, week 24|Full analysis set; Last observation carried forward||mg/dL||Standard Error|Mean
750555|NCT00545948|Secondary|Compare Drug Sensitivity Patterns of Cisplatin and Pemetrexed in Both Treatment Arms|Using genomics-based prediction models previously developed separately for cisplatin and pemetrexed, the probability that each patient was sensitive or would respond to treatment was computed. Quartiles describe the patterns of drug sensitivity probabilities. The 1st, 2nd, and 3rd quartiles are the sensitivity levels at which 25%, 50%, and 75% of patients have lower sensitivity. There is lack of integrity regarding the available data due to irreproducible genomic signatures. Therefore the results of this outcome are not presented.|2 years|There is lack of integrity regarding the available data due to irreproducible genomic signatures. Therefore the results of this outcome are not presented.|||||
750556|NCT00545948|Secondary|Patient Understanding and Perceptions of Participating in a Clinical Trial Evaluating Cancer Genomics for Adjuvant Treatment of Early Stage Lung Cancer|Do to space limitations, see the Detailed Description in the study protocol for the wording of the questions used in the Patient Expectations Questionnaire.|Baseline|Twenty-six questionnaires were returned. There was insufficient numbers to provide for substantive analysis.|||||
750557|NCT00545948|Secondary|2-Year Overall Survival in Patients Treated for NSCLC|Overall survival time was defined as the time from initiation of study treatment to the date of death as a result of any cause. Time was censored at the date of the last follow-up visit for patients who were still alive. The two-year overall survival rate is a percentage, representing the fraction of treated patients who, after two years, are alive|2 years|Due to the irreproducible nature of the genomic signatures of chemotherapeutic sensitivity, analyses based on separate treatment groups were inappropriate. Therefore, all enrolled participants (initiated for treatment) from both treatment arms were analyzed together.||percentage of treated patients||95% Confidence Interval|Number
750558|NCT00545948|Secondary|Percentage of Patients With Completely Resected NSCLC Tumors That Can Be Analyzed and Used to Direct Adjuvant Chemotherapy|The percentage of patients with completely resected NSCLC tumors who had successful genomic analysis and assigned to treatment among patients. All 31 patients enrolled in the study had completely resected tumors. These tumors included a mixture of squamous and non-squamous histologies as indicated the original protocol. However, an amendment dated January 25, 2010 limited eligibility to patients with non-squamous disease. Given that only 5 patients were accrued into the study after this amendment, results reported will consider all histologies.|4 years|||Percentage of participants|||Number
750559|NCT00545948|Primary|2-Year Progression-Free Survival Rate in Patients With Completely Resected Stage IB, II, or IIIA NSCLC|Progression-free survival time was defined as the time from initiation of study treatment to the first date of disease progression or death as a result of any cause. Progression was defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Time was censored at the date of the last follow-up visit for patients who were still alive and have not progressed. The two-year progression free survival rate is a percentage, representing the fraction of treated patients who, after two years, are disease free or alive.|2 years|Due to the irreproducible nature of the genomic signatures of chemotherapeutic sensitivity, analyses based on separate treatment groups were inappropriate. Therefore, all enrolled participants (initiated for treatment) from both treatment arms were analyzed together.||percentage of treated patients||95% Confidence Interval|Number
750560|NCT00545974|Primary|Clinical Global Impression of Change (CGIC)|The scale is rated on a 7-point scale, using a range of responses from 1 (very much improved) through 7 (very much worse). The clinician compares the participant's current condition to the condition at admission to the project.|26 Weeks|||units on a scale||95% Confidence Interval|Mean
750561|NCT00545974|Secondary|CDR-FTD, MMSE, FAQ, TFLS, EXIT25, UCSF FTD-Neuropsychological Test Battery: CVLT, Verbal Fluency, Modified BNT, Backward Digit Span, Digit Symbol Test, Modified Trails B, Modified Unified Parkinson's Disease Rating Scale, Antipsychotic Therapy||26 Weeks||||||
750562|NCT00545974|Primary|Change in Neuropsychiatric Inventory (NPI)|NPI:12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, nighttime behavior. A screening question is asked about each sub-domain. If the responses to these questions indicate that the patient has problems with a particular sub-domain of behavior, the caregiver is only then asked all the questions about that domain, rating the frequency of the symptoms on a 4-point scale, their severity on a 3-point scale, and the distress the symptom causes them on a 5-point scale. Severity(1=Mild to 3=Severe),frequency(1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score(range 0-12). Total score=sum of each domain score(range 0-144);higher score=greater behavioral disturbances;negative change score from baseline=improvement.|Baseline, 26 weeks|||units on a scale||95% Confidence Interval|Mean
750563|NCT00546000|Secondary|Record Skin Atrophy, Pigmentation Change, Hematological and Chemistry Assessments, and Changes in Atopic Dermatitis Severity|The frequency distributions of the presence/absence of adverse events associated with signs of atrophy and pigmentation changes were summarized with frequency counts. Hematology and Chemistry Assessments were summarized in shift tables. Signs and symptoms of AD were summarized at each visit.|Over 5-6 visits following the baseline visit through the end of treatment between Day 22-29|||participants|||Number
750564|NCT00546000|Primary|Post Treatment Serum Cortisol Values Will be Compared.|The primary safety parameter was the response to the CST at the end of treatment/final visit. Blood samples were collected prior to injection of cosyntropin and post-injection. Post-CST stimulation cortisol level ≤ 18micrograms/dL was considered as evidence of adrenal suppression.|Up to 29 days of treatment|||participants|||Number
750565|NCT00546052|Other Pre-specified|Absolute Change in C Reactive Protein Between Baseline and 52 Week Assessments|Absolute Change in C Reactive Protein Between Baseline and 52 week assessments: C Reactive Protein 52 weeks – C Reactive Protein Baseline.|52 Weeks - Baseline|Per Protocol||mg/L||Standard Deviation|Mean
750567|NCT00546052|Other Pre-specified|Percent Change in Total Cholesterol Between Baseline and 52 Week Assessments|Percent Change in Total Cholesterol Between Baseline and 52 week assessments: 100% x [(Total Cholesterol 52 weeks – Total Cholesterol Baseline) / (Total Cholesterol Baseline)].|52 Weeks - Baseline|Per Protocol||Percent Change||Standard Deviation|Mean
750568|NCT00546052|Other Pre-specified|Percent Change in Triglycerides Between Baseline and 52 Week Assessments|Percent Change in Triglycerides Between Baseline and 52 week assessments: 100% x [(Triglycerides 52 Weeks – Triglycerides Baseline) / (Triglycerides Baseline)].|52 Weeks - Baseline|Per Protocol||Percent Change||Standard Deviation|Median
750569|NCT00546052|Other Pre-specified|Percent Change in High Density Lipoprotein-C Between Baseline and 52 Week Assessments|Percent Change in HDL-C Between Baseline and 52 week assessments: 100% x [(HDL-C 52 Weeks – HDL-C 52 Baseline) / (HDL-C Baseline)].|52 Weeks - Baseline|Per Protocol||Percent Change||Standard Deviation|Mean
750570|NCT00546052|Other Pre-specified|Percent Change in Low Density Lipoprotein-C Between Baseline and 52 Week Assessments|Percent Change in LDL-C Between Baseline and 52 week assessments: 100% x [(LDL-C 52 Weeks – LDL-C Baseline) / (LDL-C Baseline)].|52 Weeks - Baseline|Per Protocol||Percent Change||Standard Deviation|Mean
750571|NCT00546052|Other Pre-specified|Change in Body Mass Index Between Baseline and 52 Week Assessments|Absolute change in Body Mass Index Baseline and 52 week assessments|52 Weeks - Baseline|Per Protocol||Kg/m2||Standard Deviation|Mean
750572|NCT00546052|Other Pre-specified|Change in Waist Circumference Between Baseline and 52 Week Assessments|Absolute change in Waist Circumference between baseline and 52 week assessments|52 Weeks - Baseline|Per Protocol||cm||Standard Deviation|Mean
750573|NCT00546052|Secondary|Change in Diastolic Blood Pressure Between Baseline and 52 Week Assessments|Absolute change in Diastolic Blood Pressure between baseline and 52 week assessments.|52 Weeks - Baseline|Per Protocol||mm Hg||Standard Deviation|Mean
750574|NCT00546052|Secondary|Change in Systolic Blood Pressure Between Baseline and 52 Week Assessments|Absolute change in Systolic Blood Pressure between baseline and 52 week assessments.|52 Weeks - Baseline|Per Protocol||mm Hg||Standard Deviation|Mean
750575|NCT00546052|Secondary|Target Blood Pressure|Target Blood Pressure defined as Systolic Blood Pressure/Diastolic Blood Pressure ≤ 140/90 mm Hg at 52 weeks|52 Weeks|ITT and Per Protocol||Participants|||Number
750576|NCT00546052|Primary|Change in Fasting Blood Glucose Between Baseline and 52 Weeks Assessments|Absolute Change in Fasting Blood Glucose Measurements between Baseline and 52 week assessments.|52 Weeks - Baseline|Per Protocol||mmol/L||Standard Deviation|Mean
750577|NCT00546052|Primary|Change in Hemoglobin A1c Between 52 Weeks and Baseline|Absolute Change in Hemoglobin A1c between 52 week measurement and baseline value.|52 Weeks - Baseline|Per Protocol||Percent||Standard Deviation|Median
750578|NCT00546078|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Day 0 up to Month 18|||subjects|||Number
750579|NCT00546078|Secondary|Number of Subjects With New Onset of Chronic Diseases (NOCDs), New Onset of Autoimmune Diseases (NOADs) and Medically Significant Conditions (MSCs)|NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. MSC include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|From Day 0 up to Month 18|||subjects|||Number
750580|NCT00546078|Secondary|Outcome of Any Reported Pregnancies|Information on any subject who became pregnant while participating in this study was collected. The outcomes of the pregnancies are reported below.|From Day 0 up to Month 18|Analysis was performed on those subjects reporting pregnancy during the study period.||Outcome|||Number
750581|NCT00546078|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|"An unsolicited adverse event is defined as any adverse event (AE) reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.
AEs reported after the 4th vaccine dose in the 4-dose Group and after the 3 doses administered in this study in the 3-dose Group are disclosed."|Within 30 days of vaccination|||subjects|||Number
750582|NCT00546078|Primary|Anti-HPV-16 and Anti-HPV-18 Antibody Titers|Titers are given as geometric mean titers (GMTs) calculated on all subjects.|At Day 7 and at Month 1 (Day 30)|Analysis was performed on the ATP cohort for immunogenicity.||titer||95% Confidence Interval|Geometric Mean
750583|NCT00546078|Secondary|Number of Subjects Reporting Solicited General Symptoms|"Solicited general symptoms assessed include arthralgia, fatigue, fever, gastrointestinal discomfort, headache, myalgia, rash and urticaria.
Solicited symptoms reported after the 4th vaccine dose in the 4-dose Group and across the 3 doses administered during this study in the 3-dose Group are disclosed."|Within 7 days of vaccination|Analysis was performed on those subjects from the Total Vaccinated Cohort with available results.||subjects|||Number
750584|NCT00546078|Secondary|Number of Subjects Reporting Solicited Local Symptoms|"Solicited local symptoms assessed include pain, redness and swelling at the injection site.
Solicited symptoms reported after the 4th vaccine dose in the 4-dose Group and across the 3 doses administered during this study in the 3-dose Group are disclosed."|Within 7 days after vaccination|Analysis was performed on those subjects from the Total Vaccinated Cohort with available results.||subjects|||Number
750585|NCT00546078|Secondary|Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervico-vaginal Secretion Samples|"Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).
Analyses were done in all collected samples from the evaluable subjects who provided cervical samples with < 200 erythrocytes per microliter."|Day 0, Month 1 (Day 30), Month 7 and Month 18|Analysis was performed on the subset of subjects from the ATP cohort for immunogenicity for whom cervical secretion samples were collected.||EL.U/mL||95% Confidence Interval|Geometric Mean
750846|NCT00554463|Primary|Incidence of Grade 4 Neutropenia or Grades 3-4 Febrile Neutropenia Episodes During Concurrent Chemoradiotherapy as Assessed by NCI CTCAE v 3.0 (Common Terminology Criteria for Adverse Events)|This study stopped accrual early with 5 accrued out of 44 planned, therefore no analyses were performed.|At the completion of all treatment, approximately 80 days||||||
750586|NCT00546078|Secondary|Number of Subjects Seropositive for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervico-vaginal Secretion Samples|"Seropositivity was defined as the detection of antibody titers above the limit of quantification by Enzyme-Linked Immunosorbant Assay. Defining a cut-off is technically not possible for this assay.
Analyses were done in all collected samples from the evaluable subjects who provided cervical samples, with < 200 erythrocytes per microliter."|Day 0, Month 1 (Day 30), Month 7 and Month 18|Analysis was performed on the subset of subjects from the ATP cohort for immunogenicity for whom cervical secretion samples were collected.||subjects|||Number
750587|NCT00546078|Secondary|Number of Subjects With B Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types|"B-cell-mediated immune responses against the antigens HPV-16, HPV-18, HPV-31 and HPV-45 were measured by Enzyme-linked immunosorbent spot (ELISPOT) assay.
A memory B-cell immune response was defined as presence of any antigen-specific memory B-cells per million B-cells."|Day 0, Month 1 [Day 30], Month 7 and Month 18|Analyses were performed on a subset (from pre-defined study sites) of subjects from the ATP cohort for immunogenicity.||subjects|||Number
750588|NCT00546078|Secondary|Number of Subjects With Cluster of Differentiation 8 (CD8) T Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types|"CD8 T cell-mediated immune responses against the antigens HPV-16, HPV-18, HPV-31 and HPV-45 were analyzed for cells expressing at least 2 of the following immune markers: CD40 Ligand, Interleukin-2, Tumor Necrosis Factor alpha or Interferon-gamma.
An immune response is defined as 200 or more antigen-specific CD8 T-cells per million CD8 T-cells."|Day 0, Month 1 [Day 30], Month 7 and Month 18|Analyses were performed on a subset (from pre-defined study sites) of subjects from the ATP cohort for immunogenicity.||subjects|||Number
750589|NCT00546078|Secondary|Number of Subjects With Cluster of Differentiation 4 (CD4) T Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types|"CD4 T cell-mediated immune responses against the antigens HPV-16, HPV-18, HPV-31 and HPV-45 were analyzed for cells expressing at least 2 of the following immune markers: CD40 Ligand, Interleukin-2, Tumor Necrosis Factor alpha or Interferon-gamma.
An immune response is defined as 500 or more antigen-specific CD4 T-cells per million CD4 T-cells."|Day 0, Month 1 [Day 30], Month 7 and Month 18|Analyses were performed on a subset (from pre-defined study sites) of subjects from the ATP cohort for immunogenicity.||subjects|||Number
750590|NCT00546078|Secondary|Anti-HPV-31 and Anti-HPV-45 Antibody Titers|Titers are given as geometric mean titers (GMTs) calculated on all subjects.|Day 7, Month 1 (Day 30), Month 7 and Month 18|Analysis was performed on the ATP cohort for immunogenicity||titer||95% Confidence Interval|Geometric Mean
750591|NCT00546078|Secondary|Number of Subjects With Antibody Titers Against Other Oncogenic HPV Types (HPV-31 & HPV-45) Greater Than or Equal to 59 EL.U/mL||Day 0, Month 1 (Day 30), Month 7 and Month 18|Analysis was performed on the ATP cohort for immunogenicity.||subjects|||Number
750592|NCT00546078|Secondary|Anti-HPV-16 and Anti-HPV-18 Antibody Titers|Titers are given as GMTs calculated on all subjects.|At Month 7 and Month 18|Analysis was performed on the APT cohort for immunogenicity||titer||95% Confidence Interval|Geometric Mean
750593|NCT00546078|Secondary|Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Greater Than or Equal to Pre-defined Cut-off Values|Cut-off values assessed include 8 EL.U/mL for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.|At Month 7 and Month 18|Analysis was performed on the ATP cohort for immunogenicity.||subjects|||Number
750594|NCT00546078|Primary|Number of Subjects With Anti-human Papilloma Virus-16 (Anti-HPV-16) and Anti-HPV-18 Antibody Titers Greater Than or Equal to Pre-defined Cut-off Values|Cut-off values assessed include 8 Enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.|At Day 7 and Month 1 (Day 30)|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity.||subjects|||Number
750595|NCT00546104|Secondary|To Explore the Association Between Dasatinib and Osteoclastic Bone Resorption|Not assessed secondary to limited number of subjects.|not assessed||||||
750596|NCT00546104|Secondary|To Explore the Association Between Each Patient's SRC Signature and Their Time to Progression.|Spearman's correlation between the change in SRC signature from baseline to 4 weeks and time to progression|Baseline Src measure to first progression|11 patients had both change in Src level and progression time intervals||correlation coefficient|||Number
750597|NCT00546104|Secondary|Correlate SRC Dysregulation Results With Response to Dasatinib Therapy|Since all patients progressed there is no comparison to between responders and non-responders.|16 weeks|20 patients with baseline and 4 week Src measures. 11 patients came off due to screen failure, toxicity or progression before 4 week biopsy.||percentage change in p-SRC||95% Confidence Interval|Mean
750598|NCT00546104|Secondary|Characterization and Comparison of SRC (A Protein Tyrosine Kinase)Dysregulation at Baseline (All Patients), After 4 Weeks of Dasatinib Treatment (All Patients), and at Progression (Only Patients Who Progress After Documented Response)|For the 20 patients with evaluable biopsies at baseline and week 4, the median relative change from baseline in tissue biomarker levels of phospho-Src (p-Src)|4 weeks|Twenty patients with evaluable biopsies at baseline and 4 week follow-up||percentage of change in p-SRC||Inter-Quartile Range|Median
750599|NCT00546104|Secondary|To Measure Response to Protocol Therapy Per RECIST Criteria|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progression At least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as a reference the smallest sum longest diameter recorded since treatment started, or the appearance of one or more new lesions.
RECIST 1.0 Overall response:
Complete Response (CR) Partial Response (PR) Stable Disease (SD) Progressive Disease (PD)
CR= CR+CR and No new lesions PR= CR+SD; PR+SD and no new lesions SD= SD+SD and no new lesions PD= PD+any new lesions"|16 weeks|Proportion with Best Response of Stable Disease||percentage of participants|||Number
750618|NCT00546351|Secondary|Average Quality of Life Using the SF-36 Health Survey – Physical Component Summary (PCS) at Baseline.|The SF-36 Health Survey measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS = physical functioning, role-physical, bodily pain, and general health; MCS = vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0 = worst score (or quality of life) and 100 = best score.|Baseline|"Of the 621 subjects in the Safety Set (SS), 588 are included in this analysis.
Data was not available for 33 subjects at the time of this measurement."||units on a scale||Standard Deviation|Mean
750600|NCT00546104|Primary|Estimation of the Proportion of Progression-free Patients at 16 Wks.|"Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or measurable increase in a non-target lesion, or the appearance of new lesions, or similar definition as appropriate.
Proportion progression-free at 16 weeks.From first day of study related treatment with Dasatinib until the date of first documented progression or date of death from any cause, whichever came first."|16 weeks|31 patients on this trial, 1 patient was found to have disease progression at 16-weeks, 16 patients had disease progression prior to 16 weeks, 8 patients were taken off-treatment due to toxicity, and 6 patients voluntarily withdrew from treatment. These latter two groups of patients were censored in the analysis of Progression Free Survival.||percentage of participants||95% Confidence Interval|Number
750601|NCT00546117|Primary|Absence of Middle Ear Fluid by Pneumatic Otoscopy, LeftEar||2 months|||participants|||Number
750602|NCT00546117|Secondary|Reflux Symptom Questionnaires||1 and 2 months||||||
750603|NCT00546117|Secondary|Tympanometry||2 months||||||
750604|NCT00546117|Secondary|Acoustic Reflectometry||2 months||||||
750605|NCT00546117|Primary|Absence of Middle Ear Fluid by Pneumatic Otoscopy, Right Ear||2 months|||participants|||Number
750606|NCT00546156|Secondary|Decrease in Interstitial Fluid Pressure.|To determine if bevacizumab monotherapy results in a decrease in interstitial fluid pressure|3 years|This represents the number of patients with paired IFP measurements from day 0 and day 14||mm Hg||Inter-Quartile Range|Median
750607|NCT00546156|Primary|Pathologic Complete Response Rate After Preoperative Therapy in This Patient Population.|Pathological Complete response is defined as complete disappearance of invasive tumor in the breast at the time of surgery|3 Years|Participants who met all study eligibility criteria and signed informed consent.||percentage of participants|||Number
750608|NCT00546260|Secondary|Percentage ST-segment Resolution Prior to PCI|The relative effect of PRT060128 on ST-segment measured after PCI and expressed as a percent of ST-Segment prior to PCI. This measure was used to evaluate the dethrombotic and early reperfusion effects of PRT060128 in STEMI.|Before primary PCI|Per protocol.||Percentage of ST-segment Resolution||Inter-Quartile Range|Median
750609|NCT00546260|Secondary|Corrected TIMI Frame Count (cTFC) in the Infarct Artery on the Initial Diagnostic Angiogram Before Primary PCI|This measure was used to assess flow in the epicardial artery. It is the number of cine frames required for contrast to reach a standardized distal coronary landmark in the culprit vessel and was to be counted using an electronic frame counter.|Time for contrast to reach a standardized distal coronary landmark in the culprit vessel|Per protocol||frames per minute||Inter-Quartile Range|Median
750610|NCT00546260|Primary|Number of Patients With Thrombolysis in Myocardial Infarction (TIMI) Major/Minor Bleeding, Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) Severe/Moderate Bleeding Through Hospital Discharge, and Intracranial Hemorrhage Through 30 Days|"TIMI Major:Intracranial bleeding or a decrease in the hemoglobin concentration of 5g/dL or more, or 15% or greater decrease in hematocrit.
TIMI Minor:Hemoglobin concentration decreased by 3g/dL (but <5g/dL) or the hematocrit decreased by 10–15%.
GUSTO Severe/life threatening:Intracranial hemorrhage or bleeding that causes hemodynamic compromise requiring intervention.
GUSTO Moderate:Bleeding that requires bloodtransfusion but does not lead to hemodynamic compromise requiring intervention.
Stroke:New focal neurologic deficit that does not resolve within 24 hours."|30 days|"All subjects receiving some component of study drug (the as-treated population)"||Participants|||Number
750611|NCT00546273|Primary|Number of Clinically Relevant Abnormalities in the Laboratory Tests According to the Doctors' Impression|haematological and biochemical laboratory tests|at protocol defined timepoints: days 0, 7, 21, 28, 35, 56, 112 & 156|All the participants of the study were analyzed for this specific outcome measure.||number of abnormalities|||Number
750612|NCT00546273|Primary|Occurrence, Intensity and Relationship to Vaccination of Local and Systemic Events||during the whole study||11/2008||||
750613|NCT00546273|Secondary|Evaluation of the Immunogenicity of the Different Doses of the Vaccine Tested|Immunological assays are performed at all timepoints to determine vaccine immunogenicity|at protocol defined timepoints: days 0, 7, 21, 28, 35, 56, 112 & 156||11/2008||||
750614|NCT00546273|Primary|VAS Pain Score (Visual Analogic Scale, That Ranges From 0 to 100) to Evaluate Each Volunteer Subjective Pain Intensity at the Inoculation Point||at protocol defined timepoints: days 0, 1, 3, 7, 21, 28, 29, 31, 35, 56||11/2008||||
750615|NCT00546351|Secondary|Average Quality of Life Using the SF-36 Health Survey – Mental Component Summary (MCS) at Last Visit.|The SF-36 Health Survey measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS = physical functioning, role-physical, bodily pain, and general health; MCS = vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0 = worst score (or quality of life) and 100 = best score.|Last Visit|"Of the 621 subjects in the Safety Set (SS), 552 are included in this analysis.
Data was not available for 69 subjects at the time of this measurement."||units on a scale||Standard Deviation|Mean
750616|NCT00546351|Secondary|Average Quality of Life Using the SF-36 Health Survey – Mental Component Summary (MCS) at Baseline.|The SF-36 Health Survey measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS = physical functioning, role-physical, bodily pain, and general health; MCS = vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0 = worst score (or quality of life) and 100 = best score.|Baseline|"Of the 621 subjects in the Safety Set (SS), 588 are included in this analysis.
Data was not available for 33 subjects at the time of this measurement."||units on a scale||Standard Deviation|Mean
750617|NCT00546351|Secondary|Average Quality of Life Using the SF-36 Health Survey – Physical Component Summary (PCS) at Last Visit.|The SF-36 Health Survey measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS = physical functioning, role-physical, bodily pain, and general health; MCS = vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0 = worst score (or quality of life) and 100 = best score.|Last Visit|"Of the 621 subjects in the Safety Set (SS), 552 are included in this analysis.
Data was not available for 69 subjects at the time of this measurement."||units on a scale||Standard Deviation|Mean
750619|NCT00546351|Secondary|Average Pain Interference With Activity (11-point Likert Scale) at Last Visit.|0 = no interference with activity and 10 = worst possible interference with activity.|Last Visit|"Of the 621 subjects in the Safety Set (SS), 619 are included in this analysis.
Data was not available for 2 subjects at the time of this measurement."||units on a scale||Standard Deviation|Mean
750620|NCT00546351|Secondary|Average Pain Interference With Activity (11-point Likert Scale) at Baseline.|0 = no interference with activity and 10 = worst possible interference with activity.|Baseline|"Of the 621 subjects in the Safety Set (SS), 620 are included in this analysis.
Data was not available for 1 subject at the time of this measurement."||units on a scale||Standard Deviation|Mean
750621|NCT00546351|Secondary|Average Pain Interference With Sleep (11-point Likert Scale) at Last Visit.|0 = no interference with sleep and 10 = worst possible interference with sleep.|Last Visit|"Of the 621 subjects in the Safety Set (SS), 619 are included in this analysis.
Data was not available for 2 subjects at the time of this measurement."||units on a scale||Standard Deviation|Mean
750622|NCT00546351|Secondary|Average Pain Interference With Sleep (11-point Likert Scale) at Baseline.|0 = no interference with sleep and 10 = worst possible interference with sleep.|Baseline|"Of the 621 subjects in the Safety Set (SS), 620 are included in this analysis.
Data was not available for 1 subject at the time of this measurement."||units on a scale||Standard Deviation|Mean
750623|NCT00546351|Secondary|Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Sensitivity at Last Visit.|0 = not sensitive and 10 = most sensitive sensation imaginable.|Baseline Visit; Last Visit (approximately 2 years)|"Of the 621 subjects in the Safety Set (SS), 195 are included in this analysis.
Data was not available for 426 subjects at the time of this measurement."||units on a scale||Standard Deviation|Mean
750624|NCT00546351|Secondary|Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Itchiness at Final Visit.|0 = not itchy and 10 = most itchy sensation imaginable.|Baseline Visit; Last Visit (approximately 2 years)|"Of the 621 subjects in the Safety Set (SS), 195 are included in this analysis.
Data was not available for 426 subjects at the time of this measurement."||units on a scale||Standard Deviation|Mean
750625|NCT00546351|Secondary|Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Deep Pain at Last Visit.|0 = no deep pain and 10 = most intense deep pain imaginable.|Baseline Visit; Last Visit (approximately 2 years)|"Of the 621 subjects in the Safety Set (SS), 193 are included in this analysis.
Data was not available for 428 subjects at the time of this measurement."||units on a scale||Standard Deviation|Mean
750626|NCT00546351|Secondary|Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Surface Pain at Last Visit.|0 = no surface pain and 10 = most intense surface pain imaginable.|Baseline Visit; Last Visit (approximately 2 years)|"Of the 621 subjects in the Safety Set (SS), 193 are included in this analysis.
Data was not available for 428 subjects at the time of this measurement."||units on a scale||Standard Deviation|Mean
750627|NCT00546351|Secondary|Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Unpleasantness at Final Visit.|0 = not unpleasant and 10 = most unpleasant sensation imaginable.|Baseline Visit; Last Visit (approximately 2 years)|"Of the 621 subjects in the Safety Set (SS), 193 are included in this analysis.
Data was not available for 428 subjects at the time of this measurement."||units on a scale||Standard Deviation|Mean
750628|NCT00546351|Secondary|Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Dullness at Last Visit.|0 = not dull and 10 = most dull sensation imaginable.|Baseline Visit; Last Visit (approximately 2 years)|"Of the 621 subjects in the Safety Set (SS), 195 are included in this analysis.
Data was not available for 426 subjects at the time of this measurement."||units on a scale||Standard Deviation|Mean
750629|NCT00546351|Secondary|Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Cold at Last Visit.|0 = not cold and 10 = the coldest sensation imaginable.|Baseline Visit; Last Visit (approximately 2 years)|"Of the 621 subjects in the Safety Set (SS), 195 are included in this analysis.
Data was not available for 426 subjects at the time of this measurement."||units on a scale||Standard Deviation|Mean
750630|NCT00546351|Secondary|Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Heat at Last Visit.|0 = not hot and 10 = the most hot sensation imaginable.|Baseline Visit; Last Visit (approximately 2 years)|"Of the 621 subjects in the Safety Set (SS), 195 are included in this analysis.
Data was not available for 426 subjects at the time of this measurement."||units on a scale||Standard Deviation|Mean
750631|NCT00546351|Secondary|Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Sharpness at Last Visit.|0 = not sharp and 10 = most sharp sensation imaginable.|Baseline Visit; Last Visit (approximately 2 years)|"Of the 621 subjects in the Safety Set (SS), 195 are included in this analysis.
Data was not available for 426 subjects at the time of this measurement."||units on a scale||Standard Deviation|Mean
750632|NCT00546351|Secondary|Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Intensity at Last Visit.|0 = no pain and 10 = most intense pain sensation imaginable.|Baseline Visit; Last Visit (approximately 2 years)|"Of the 621 subjects of the Safety Set (SS), 195 are included in this analysis.
Data was not available for 426 subjects at the time of this measurement."||units on a scale||Standard Deviation|Mean
750633|NCT00546351|Secondary|Patient’s Global Impression of Change (PGIC) at Last Visit.|"The PGIC is a 7-point self-administered categorical rating scale in which the subject rated the change in pain since starting trial medication (from much worse [score of 1] to much better [score of 7]).
Reported results are presented as Better (sum of mildly, moderately, or much better), No Change, or Worse (sum of mildly, moderately, or much worse)."|Last Visit (approximately 2 years)|"Of the 621 subjects in the Safety Set (SS), 551 are included in this analysis.
Data was not available for 70 subjects at the time of this measurement."||percentage of participants|||Number
750634|NCT00546351|Secondary|Average Pain Score as Measured by a 100 mm Visual Analogue Scale (VAS) at Last Visit.|On VAS 0 mm = no pain and 100 mm = worst possible pain.|Last Visit (approximately 2 years)|"Of the 621 subjects in the Safety Set (SS), 214 are included in this analysis.
Data was not available for 407 subjects at the time of this measurement."||units on a scale||Standard Deviation|Mean
750635|NCT00546351|Secondary|Average Pain Score as Measured by a 100 mm Visual Analog Scale (VAS) at Baseline.|Visual Analog Scale (VAS) 0 mm = no pain and 100 mm = worst possible pain.|Baseline|"Of the 621 subjects in the Safety Set (SS), 213 are included in this analysis.
Data was not available for 408 subjects at the time of this measurement."||units on a scale||Standard Deviation|Mean
750636|NCT00546351|Secondary|Average Daily Pain Score Using an 11-point Likert Scale (0-10) at Last Visit.|On the Likert Scale, 0 = no pain and 10 = worst possible pain.|Last Visit (approximately 2 years)|"Of the 621 subjects in the Safety Set (SS), 619 are included in this analysis.
Data was not available for 2 subjects at the time of this measurement."||units on a scale||Standard Deviation|Mean
750637|NCT00546351|Secondary|Average Daily Pain Score Using an 11-point Likert Scale (0-10) at Baseline Visit.|On the Likert Scale, 0 = no pain and 10 = worst possible pain.|Baseline|"Of the 621 subjects in the Safety Set (SS), 620 are included in this analysis.
Data was not available for 1 subject at the time of this measurement."||units on a scale||Standard Deviation|Mean
750638|NCT00546351|Primary|Number of Participants Experiencing the Occurrence of at Least One Serious Adverse Event (SAE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (Approximately 6.5 Years).|"A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose:
Is fatal
Is life-threatening
Results in persistent or significant disability/incapacity
Requires inpatient hospitalization
Prolongs existing inpatient hospitalization
Is a congenital anomaly/birth defect
Is considered to be an important medical event. Such an event may not be immediately life threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent one of the other outcomes listed in the definitions above"|From entry Visit 1 through end of treatment (approximately 6.5 years)|This analysis includes all subjects (all 621) in the Safety Set (SS).||participants|||Number
750639|NCT00546351|Primary|Number of Participants Experiencing the Occurrence of at Least One Treatment-emergent Adverse Event (TEAE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (Approximately 6.5 Years).|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|From entry Visit 1 through end of treatment (approximately 6.5 years)|This analysis includes all subjects (all 621) in the Safety Set (SS).||participants|||Number
750640|NCT00546364|Secondary|Median Number of Treatment Cycles|The first dosing date is defined as the date of the first dose of chemotherapy or capecitabine, whichever was administered first. Cycles are defined as the time from Day 1 of the cycle until the day before the next cycle. The last cycle per participant is the 21-day period following Day 1 of that cycle.|Day 1 to end of Cycle 18, maximum (54 weeks)|All participants who received at least 1 dose of ixabepilone plus capecitabine or of docetaxel plus capecitabine.||Treatment cycles||Full Range|Median
750641|NCT00546364|Primary|Percentage of Participants With Best Response to Treatment of Complete or Partial|The tumor response rate is defined as the number of participants with a best tumor response of CR or PR (as assessed by the investigator according to RECIST criteria), divided by the number of participants randomized in that arm.|Baseline to 6 weeks (end of Cycle 2)|All participants with measurable disease who have a correct cancer diagnosis and have received any treatment.||Percentage of patients|||Number
750642|NCT00546364|Secondary|Duration of Response|Duration of overall response is computed for participants whose best response is either PR or CR and is measured from the time measurement criteria are first met for CR or PR (whichever status is recorded first) until the first date of documented PD or death. Participants who did not relapse or die are censored on the date of their last tumor assessment.|Baseline (date of randomization) to date CR or PR criteria first met|This study was terminated due to inadequate enrollment. Consequently, duration of response was not analyzed.|||||
750643|NCT00546364|Secondary|Time to Progression|Time to progression is defined as the time from date of randomization until the date that PD is first reported. Participants who die without a reported prior progression are considered to have progressed on the day of their death. Those who did not progress or die are censored at the day of their last tumor assessment.|Baseline to date progressive disease reported|This study was terminated due to inadequate enrollment. Consequently, time to progression was not analyzed.|||||
750644|NCT00546364|Secondary|Number of Participants With Abnormalities in Serum Chemistry Laboratory Results|ULN=Upper limit of normal among all laboratory ranges. Alanine aminotransferase (ALT) Grade 1:>ULN to 2.5*ULN; Grade 2: >2.5 to 5.0*ULN; Grade 3: >5.0 to 20.0*ULN; Grade 4: >20.0*ULN. Aspartate aminotransferase (AST) Grade 1: >ULN to 2.5*ULN; Grade 2: >2.5 to 5.0*ULN; Grade 3: >5.0 to 20.0*ULN; Grade 4: >20.0*ULN. Total bilirubin Grade 1: >ULN to 1.5*ULN; Grade 2: >1.5 to 3.0*ULN; Grade 3: >3.0 to 10.0*ULN; Grade 4: >10.0*ULN. Creatine Grade 1: >ULN to 1.5*ULN; Grade 2: 1.5 to 3.0*ULN; Grade 3: >3.0 to 6.0*ULN; Grade 4: >6.0*ULN.|Baseline in Cycle 1 (21 days) and then prior to start of each 21-day cycle|All participants who received at least 1 dose of ixabepilone plus capecitabine or of docetaxel plus capecitabine.||Participants|||Number
750645|NCT00546364|Secondary|Number of Participants With Abnormalities in Hematology Laboratory Results by Worst Common Terminology Criteria (CTC) Grade|CTC Grade 1=Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2=Moderate; minimal, local or noninvasive intervention indicated. Grade 3=Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling. Grade 4=Life-threatening consequences; urgent intervention indicated.|Baseline in Cycle 1 (21 days) and then prior to start of each 21-day cycle|All participants who received at least 1 dose of ixabepilone plus capecitabine or of docetaxel plus capecitabine.||Participants|||Number
750646|NCT00546364|Secondary|Number of Participants With Death, Adverse Events (AEs), Drug-related AEs, Serious AEs (SAEs), Drug-related SAEs, AEs Leading to Discontinuation (AEDs), Drug-related AEDs, and Drug-related Peripheral Neuropathy|An AE is any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=possibly, probably, or certainly related or of unknown relationship to study treatment. Grade 3=Severe, Grade 4=Life-threatening.|Baseline to end of Cycle 1 (21 days), continuously|All participants who received at least 1 dose of ixabepilone plus capecitabine or of docetaxel plus capecitabine.||Participants|||Number
750700|NCT00546637|Secondary|Change From Baseline in IPSS Storage Domain (Sum Q2, Q4, and Q7) Per 24 Hours at Week 4 and 12|The IPSS Total Score is obtained by combining the scores of the responses to 1 though 7 component questions. Each question is scored from 0-5. Total IPSS range = 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Sum of Q2, Q4, and Q7 range = 0-15 points.|Baseline, Week 4 and 12|FAS subjects with non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.||scores on scale||Standard Error|Least Squares Mean
750647|NCT00546364|Secondary|Percentage of Nontriple-negative (NTN) Participants With Best Response to Treatment of Complete or Partial Per Cohort|The tumor response rate is defined as the total number of participants whose best response is CR or PR, divided by the number of randomized participants. Participants not evaluable for response are considered to be nonresponders. NTN participants are who are not TN participants (TN participants are those with tumors that do not express estrogen or progesterone receptors and that do not overexpress HER2) and who received ixabepilone plus capecitabine or docetaxel plus capecitabine.|Baseline to 6 weeks (end of Cycle 2)|All NTN participants who received ixabepilone plus capecitabine or docetaxel plus capecitabine.||Percentage of NTN Participants|||Number
750648|NCT00546364|Secondary|Percentage of Triple-negative (TN) Participants With Best Response to Treatment of Complete or Partial|The tumor response rate is defined as the total number of participants whose best response is CR or PR, divided by the number of randomized participants. Participants not evaluable for response are considered to be nonresponders. TN participants are those with tumors that do not express estrogen or progesterone receptors and that do not over express human epidermal growth factor receptor 2 (HER2).|Baseline to 6 weeks (end of Cycle 2)|All TN participants who received ixabepilone plus capecitabine or docetaxel plus capecitabine.||Percentage of TN Participants|||Number
750649|NCT00546364|Primary|Number of Participants With Best Tumor Response as Assessed With Response Evaluation Criteria in Solid Tumors (RECIST)|RECIST definitions: Complete reponse (CR)=disappearance of all nontarget lesions; partial response (PR)=at least 30% reduction in the sum of the longest diameter (LD) of all target lesions in reference to the baseline sum LD; stable disease (SD)=neither PR nor progressive disease (PD) criteria were met; PD=at least 20% increase in the sum of the LD of all target lesions, taking as reference the smallest sum LD recorded at or following baseline. Tumor status assessed by investigator.|Baseline to 6 weeks (end of Cycle 2)|All participants with measurable disease who have a correct cancer diagnosis and have received any treatment.||Participants|||Number
750650|NCT00546377|Primary|Maximum Tolerated Dose (MTD) of Mitoxantrone|The MTD is defined as the highest dose studied for which the incidence of DLT is less than 33%. In the phase I portion of the trial, cohorts of 3-6 pts will receive pentostatin, cyclophosphamide and rituximab along with one of three potential dose levels of mitoxantrone. The following dose escalation scheme will be followed: If none of the initial three pts in a cohort experience a dose-limiting toxicity (grade 4 infection, or grade ≥ 3 non-hematologic toxicity that persists for 7 days or more) then a new cohort of three pts will be treated at the next higher dose level. If one of the three pts in a cohort experiences DLT, then up to three additional pts will be treated at the same dose level. If two or more pts in a cohort experience DLT, then the maximum tolerated dose (MTD) will have been exceeded, and no further dose escalation will occur. The previous dose level will be considered as the MTD.|2 years|||mg/m2|||Number
750651|NCT00546377|Primary|Overall Response|Complete response (CR): Absence of lymphadenopathy, hepatomegaly or splenomegaly by physical examination and appropriate radiographic techniques (if abnormal pre-treatment): it is recognized that some patients with lymphoid malignancies who achieve a CR may have mild persistent abnormalities on CT Scan. Such abnormalities if stable on subsequent scanning will not be viewed as persistent disease in patients who otherwise meet the criteria for CR. Response will be assessed on an ongoing basis, but at a minimum of prior to cycle four and following completion of all therapy. Patients who are removed from study early will have response status determined at time of removal from study. The major criteria for determination of response to therapy in patients with CLL include physical examination and examination of the peripheral blood and bone marrow. Radiographic studies are not required but those that were abnormal pre-treatment, will be repeated to document the degree of maximal response.|3 years|||participants|||Number
750652|NCT00546429|Secondary|Merle d'Aubigne and Postel||4 weeks, 3, 6 and 12 months||||||
750653|NCT00546429|Secondary|SF-12||4 weeks, 3, 6 and 12 months||||||
750654|NCT00546429|Secondary|Six Item Screener and Ambulatory Status||4 weeks, 3, 6 and 12 months||||||
750655|NCT00546429|Secondary|Medical Imaging||4 weeks, 3, 6 and 12 months||||||
750656|NCT00546429|Secondary|Lower Extremity Measure (LEM)||4 weeks, 3, 6 and 12 months||||||
750657|NCT00546429|Primary|Success in Terms of the Merle D'Aubigne Score|Merle D'Aubigne measures pain, mobility and ability to walk using a 0 to 6 scoring scale, with 0 indicating worse outcomes and 6 indicating better outcomes.|4 weeks, 3, 6 and 12 months|||Units on a scale||Standard Deviation|Mean
750658|NCT00546481|Secondary|Number of Participants With Abnormal Changes in Electrocardiogram up to Week 24|Twelve-lead ECG was recorded before or after the dialysis session. Number of participants with abnormal changes in electrocardiogram observed at any time point was reported. One participant from CERA group and two participants from Epoetin Beta group did not receive any study medication and were excluded from the safety analysis.|Up to Week 24|All participants who received at least one dose of the study medication and had a safety follow-up, whether withdrawn prematurely or not, included in the Safety Population. Only participants available at the time of assessment were included in the analysis.||Number of participants|||Number
750659|NCT00546481|Secondary|Mean Change From Baseline in Vital Sign: Heart Rate Measurements up to Week 24|Heart rate was measured before blood sampling for all participants and before the dialysis session. Baseline is defined as Day 1. One participant from CERA group and two participants from Epoetin Beta group did not receive any study medication and were excluded from the safety analysis.|From Baseline (Day 1) to Week 24|All participants who received at least one dose of the study medication and had a safety follow-up, whether withdrawn prematurely or not, included in the Safety Population. Only participants available at the time of assessment were included in the analysis.||Beats per minute for heart rate||Standard Deviation|Mean
750660|NCT00546481|Secondary|Mean Change From Baseline in Vital Signs: Systolic Blood Pressure and Diastolic Blood Pressure up to Week 24|Change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) at Baseline and end of correction phase (Week 24) is presented. SBP and DBP were determined both before and after the dialysis session for participants. Baseline is defined as Day 1 visit. One participant from CERA group and two participants from Epoetin Beta group did not receive any study medication and were excluded from the safety analysis.|From Baseline (Day 1) to Week 24|All participants who received at least one dose of the study medication and had a safety follow-up, whether withdrawn prematurely or not, included in the Safety Population. Only participants available at the time of assessment were included in the analysis.||millimeters of mercury||Standard Deviation|Mean
750661|NCT00546481|Secondary|Number of Participants With Any Adverse Events and Serious Adverse Events|An adverse event (AE) was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Number of participants with at least one AE and SAE were reported.|Up to Week 49|All participants who received at least one dose of the study medication and had a safety follow-up, whether withdrawn prematurely or not, included in the Safety Population. One participant from CERA group and two participants from Epoetin Beta group did not receive any study medication and were excluded from the safety analysis.||Number of participants|||Number
750662|NCT00546481|Secondary|Number of Participants Who Received Red Blood Cells Transfusions up to Week 49|The number of participants who received at least 1 red blood cell transfusion during the study is presented. RBC transfusions was given in case of medical need, i.e., in severely anemic participants with recognized symptoms or signs of anemia (e.g., in participants with acute blood loss, with severe angina, or whose Hb decreases to critical levels)|Up to Week 49|The Intent-to-Treat Population included all randomized participants.||Number of participants|||Number
750663|NCT00546481|Secondary|Median Time in Which Hemoglobin Value Was Maintained Within Target Range of >/= 11g/dL up to Week 24|Median time during the correction period in which Hb value was maintained within target range of >/= 11.0 g/dL and an increase in hemoglobin from baseline >/= 1.0 g/dL was reported.|Up to Week 24|The Intent-to-Treat population included all randomized participants.||Days||95% Confidence Interval|Median
750664|NCT00546481|Secondary|Mean Change From Baseline in Hemoglobin Concentration at Week 24|Mean hemoglobin levels and their changes in correction phase from baseline were presented. Baseline is defined as Day 1 visit. The mean Hb concentration from Baseline at week 24 was calculated by subtracting the baseline Hb concentration value from the week 24 value|From Baseline (Day 1) to Week 24|The Intent-to-Treat population included all randomized participants.||Grams per deciliter (g/dL)||Standard Deviation|Mean
750665|NCT00546481|Primary|Percentage of Participants Who Achieved Hemoglobin Response up to Week 24|Hemoglobin (Hb) response was defined as increase of Hb by at least 1 g/dL compared with baseline and Hb>/=11 g/dL without red blood cell transfusion during 24-week correction phase. The average baseline value was estimated by the mean of all values recorded between the day of first study dose and the previous 20 days. The percentage of participants who achieved Hb response is presented|Up to Week 24|The Intent-to-Treat population included all randomized participants.||Percentage of participants||95% Confidence Interval|Number
750666|NCT00546572|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1)|Systemic events reported using electronic diary. Fever scaled as Any (≥38 degrees Celsius [C]); Mild (≥38 but <38.5 degrees C); Moderate (≥38.5 but <39 degrees C); Severe (≥39 but ≤40 degrees C); Potentially life-threatening (>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New generalized muscle pain (New muscle pain), Aggravated generalized muscle pain (Aggravated muscle pain), New generalized joint pain (New joint pain), and Aggravated generalized joint pain (Aggravated joint pain).|Days 1 through 14 / Year 0, Days 1 through 14 / Year 1|Safety population; N=number of participants who reported any systemic reactogenicity events; (n)=number of participants with known values for 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1). Participants may be represented in more than 1 category.||percentage of participants|||Number
750667|NCT00546572|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1)|Systemic events reported using electronic diary. Fever scaled as Any (≥38 degrees Celsius [C]); Mild (≥38 but <38.5 degrees C); Moderate (≥38.5 but <39 degrees C); Severe (≥39 but ≤40 degrees C); Potentially life-threatening (>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New generalized muscle pain (New muscle pain), Aggravated generalized muscle pain (Aggravated muscle pain), New generalized joint pain (New joint pain), and Aggravated generalized joint pain (Aggravated joint pain).|Days 1 through 14 / Year 1|Safety population; N=number of participants who reported any systemic reactogenicity events; (n)=number of participants with known values for 13vPnC / 13vPnC and 23vPS / 13vPnC (Year 1). Participants may be represented in more than 1 category.||percentage of participants|||Number
750668|NCT00546572|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)|Systemic events reported using electronic diary. Fever scaled as Any (≥38 degrees Celsius [C]); Mild (≥38 but <38.5 degrees C); Moderate (≥38.5 but <39 degrees C); Severe (≥39 but ≤40 degrees C); Potentially life-threatening (>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New generalized muscle pain (New muscle pain), Aggravated generalized muscle pain (Aggravated muscle pain), New generalized joint pain (New joint pain), and Aggravated generalized joint pain (Aggravated joint pain).|Days 1 through 14 / Year 0, Days 1 through 14 / Year 1|Safety population; N=number of participants who reported any systemic reactogenicity events; (n)=number of participants with known values for 23vPS (Year 0) and 13vPnC / 13vPnC (Year 1). Participants may be represented in more than 1 category.||percentage of participants|||Number
750669|NCT00546572|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)|Systemic events reported using electronic diary. Fever scaled as Any (≥38 degrees Celsius [C]); Mild (≥38 but <38.5 degrees C); Moderate (≥38.5 but <39 degrees C); Severe (≥39 but ≤40 degrees C); Potentially life-threatening (>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New generalized muscle pain (New muscle pain), Aggravated generalized muscle pain (Aggravated muscle pain), New generalized joint pain (New joint pain), and Aggravated generalized joint pain (Aggravated joint pain).|Days 1 through 14 / Year 0, Days 1 through 14 / Year 1|Safety population; N=number of participants who reported any systemic reactogenicity events; (n)=number of participants with known values for 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1). Participants may be represented in more than 1 category.||percentage of participants|||Number
750670|NCT00546572|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0)|Systemic events reported using electronic diary. Fever scaled as Any (≥38 degrees Celsius [C]); Mild (≥38 but <38.5 degrees C); Moderate (≥38.5 but <39 degrees C); Severe (≥39 but ≤40 degrees C); Potentially life-threatening (>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New generalized muscle pain (New muscle pain), Aggravated generalized muscle pain (Aggravated muscle pain), New generalized joint pain (New joint pain), and Aggravated generalized joint pain (Aggravated joint pain).|Days 1 through 14 / Year 0|Safety population; N=number of participants who reported any systemic reactogenicity events; (n)=number of participants with known values for 13vPnC and 23vPS (Year 0). Participants may be represented in more than 1 category.||percentage of participants|||Number
750671|NCT00546572|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1)|Local reactions reported in electronic diary. Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters [cm] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (>10.0 cm). Pain scaled as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move above shoulder)|Days 1 through 14 / Year 0, Days 1 through 14 / Year 1|Safety population; N=number of participants who reported any local reaction reactogenicity events; (n)=number of participants with known values for 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1). Participants may be represented in more than 1 category.||percentage of participants|||Number
750672|NCT00546572|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1 )|Local reactions reported in electronic diary. Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters [cm] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (>10.0 cm). Pain scaled as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move above shoulder)|Days 1 through 14 / Year 1|Safety population; N=number of participants who reported any local reaction reactogenicity events; (n)=number of participants with known values for 13vPnC / 13vPnC and 23vPS / 13vPnC (Year 1). Participants may be represented in more than 1 category.||percentage of participants|||Number
750673|NCT00546572|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)|Local reactions reported in electronic diary. Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters [cm] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (>10.0 cm). Pain scaled as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move above shoulder)|Days 1 through 14 / Year 0, Days 1 through 14 / Year 1|Safety population; N=number of participants who reported any local reaction reactogenicity events; (n)=number of participants with known values for 23vPS (Year 0) and 13vPnC / 13vPnC (Year 1). Participants may be represented in more than 1 category.||percentage of participants|||Number
750674|NCT00546572|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)|Local reactions reported in electronic diary. Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters [cm] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (>10.0 cm). Pain scaled as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move above shoulder)|Days 1 through 14 / Year 0, Days 1 through 14 / Year 1|Safety population; N=number of participants who reported any local reaction reactogenicity events; (n)=number of participants with known values for 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1). Participants may be represented in more than 1 category.||percentage of participants|||Number
750675|NCT00546572|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0)|Local reactions reported in electronic diary. Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters [cm] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (>10.0 cm). Pain scaled as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move above shoulder)|Days 1 through 14 / Year 0|Safety population is all participants who receive at least 1 dose of study vaccine. N=number of participants who reported any local reaction reactogenicity events; (n)=number of participants with known values for 13vPnC and 23vPS (Vax 1). Participants may be represented in more than 1 category.||percentage of participants|||Number
750676|NCT00546572|Secondary|Pneumococcal OPA Geometric Mean Titer (GMT) for Serotype 6A for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 23vPS (Vax 1 / Year 0)|Antibody geometric mean titer as measured by OPA assay for the 6A serotype. Confidence intervals (CI) for the GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titer.|1 month after Vax 1 / Year 0, 1 month after Vax 2 / Year 1|Evaluable Immunogenicity population; N=number of participants with a determinate OPA antibody titer to the given serotype.||geometric mean titer||95% Confidence Interval|Geometric Mean
750727|NCT00553475|Secondary|Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Sleep Adequacy|The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for sleep adequacy ranges from 0-100. Higher scores indicate more of the attribute.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
750677|NCT00546572|Secondary|Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 23vPS (Vax 1 / Year 0)|Antibody geometric mean titers as measured by OPA assays for the 12 common serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|1 month after Vax 1 / Year 0, 1 month after Vax 2 / Year 1|Evaluable Immunogenicity population; N=number of participants with a determinate OPA antibody titer to the given serotype.||geometric mean titers||95% Confidence Interval|Geometric Mean
750678|NCT00546572|Secondary|Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 13vPnC (Vax 1 / Year 0)|Antibody geometric mean titers as measured by OPA assays for the 13 serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|1 month after Vax 1 / Year 0, 1 month after Vax 2 / Year 1|Evaluable Immunogenicity population; N=number of participants with a determinate OPA antibody titer to the given serotype at both the postvaccination 1 and postvaccination 2 blood draws.||geometric mean titer||95% Confidence Interval|Geometric Mean
750679|NCT00546572|Secondary|Pneumococcal OPA Geometric Mean Titer (GMT) for Serotype 6A for 13vPnC Relative to 23vPS (Vax 1 / Year 0)|Antibody geometric mean titer as measured by OPA assay for the 6A pneumococcal serotype. Confidence intervals for the GMT are back transformation of a CI based on the Student t distribution for the mean logarithm of the titer.|1 month after Vax 1 / Year 0|Evaluable Immunogenicity population. N=number of participants with a determinate OPA antibody titer to the given serotype.||geometric mean titer||95% Confidence Interval|Geometric Mean
750680|NCT00546572|Primary|Percentage of Participants Achieving a ≥ 4-fold Rise for Serotype 6A OPA Titer for 13vPnC Relative to 23vPS (Vax 1 / Year 0)|OPA titer for the 6A serotype measured for at least a 4-fold increase from the prevaccination to postvaccination blood sample collection. Exact 2-sided CI (Clopper and Pearson) based upon the observed percentage of participants.|Baseline, 1 month after Vax 1 / Year 0|Evaluable Immunogenicity population. N=number of participants with a determinate antibody titer to the given serotype.||observed percentage of participants||95% Confidence Interval|Number
750681|NCT00546572|Primary|Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC Relative to 23vPS (Vax 1 / Year 0)|Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assays for the 12 common serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|1 month after Vax 1 / Year 0|Evaluable Immunogenicity population: treatments as randomized at all expected doses, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations. N=number of participants with a determinate OPA antibody titer to the given serotype.||geometric mean titer||95% Confidence Interval|Geometric Mean
750682|NCT00546637|Secondary|Number of Participants Experiencing Adverse Events Related to Increased Voiding Difficulty (All Causalities)|Number of participants experiencing serious and non-serious adverse events related to increased voiding difficulty (ie, Dysuria, Urinary retention regardless of catheterization, Urine flow decreased, Residual urine volume, Residual urine volume increased, Residual urine, and Urinary hesitation)|Baseline, Week 12|The safety analysis set included all subjects who took at least one dose of study drug.||participants|||Number
750683|NCT00546637|Secondary|Number of Participants Reporting Urinary Retention Requiring Catheterization (All Causalities)|Number of participants experiencing serious and non-serious adverse events of acute urinary retention requiring catheterization.|Baseline, Week 12|The safety analysis set included all subjects who took at least one dose of study drug.||participants|||Number
750684|NCT00546637|Secondary|Change From Baseline in Maximum Urinary Flow Rate (QMAX) Per 24 Hours at Week 12|Maximum urinary flow rate (Qmax) was recorded at Baseline and Week 12 visit.|Baseline, Week 12|The safety analysis set included all subjects who took at least one dose of study drug. Subjects in the safety analysis set with non missing change from Baseline to Week 12 (LOCF) were included in the analysis.||ml/sec||Full Range|Median
750685|NCT00546637|Secondary|Change From Baseline in Post Void Residual (PVR) Urine Volume Per 24 Hours at Week 4, 8 and 12|Post-void residual volume measurement was measured by an ultrasound at Baseline, and at Weeks 4, 8 and 12.|Baseline, Week 4, 8 and 12|The safety analysis set included all subjects who took at least one dose of study drug. Subjects in the safety analysis set with non missing change from Baseline to Week 4, Week 8 (LOCF), or Week 12 (LOCF) were included in the analysis.||ml||Full Range|Median
750686|NCT00546637|Secondary|Change From Baseline in Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 (OAB-q Social Interaction Domain)|The HRQL social interaction domain; range was 0-100. The transformed score for HRQL was calculated based on the following formula: Transformed score (HRQL) = [(Highest possible score – Actual raw score)/ Range]*100, where range was the raw score range. Positive change in HRQL Score indicates improvement.|Baseline, Week 4 and Week 12|FAS subjects with non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.||scores on a scale||Standard Error|Least Squares Mean
750687|NCT00546637|Secondary|Change From Baseline in Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 (OAB-q Sleep Domain)|The HRQL sleep domain; range was 0-100. The transformed score for HRQL was calculated based on the following formula: Transformed score (HRQL) = [(Highest possible score – Actual raw score)/ Range]*100, where range was the raw score range. Positive change in HRQL Score indicates improvement.|Baseline, Week 4 and Week 12|FAS subjects with non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.||scores on a scale||Standard Error|Least Squares Mean
750688|NCT00546637|Secondary|Change From Baseline in Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 (OAB-q Coping Domain)|The HRQL coping domain; range was 0-100. The transformed score for HRQL was calculated based on the following formula: Transformed score (HRQL) = [(Highest possible score – Actual raw score)/ Range]*100, where range was the raw score range. Positive change in HRQL Score indicates improvement.|Baseline, Week 4 and Week 12|FAS subjects with non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.||scores on a scale||Standard Error|Least Squares Mean
753674|NCT00577824|Secondary|Change in Body Weight|Change in body weight form baseline to endpoint (i.e., body weight at week 24 minus body weight at week 0)|baseline, week 24|Full analysis set; Last observation carried forward||kg||Standard Error|Least Squares Mean
750689|NCT00546637|Secondary|Change From Baseline in Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 (OAB-q Concern Domain)|The HRQL concern domain; range was 0-100. The transformed score for HRQL was calculated based on the following formula: Transformed score (HRQL) = [(Highest possible score – Actual raw score)/ Range]*100, where range was the raw score range. Positive change in HRQL Score indicates improvement.|Baseline, Week 4 and 12|FAS subjects with non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.||scores on scale||Standard Error|Least Squares Mean
750690|NCT00546637|Secondary|Change From Baseline in Total Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12|HRQL domain and total raw score derived as sum of scores (6-point scale: 1 = not at all/none of the time; 6 = a very great deal/all of the time). Transformed score range 0 to 100 (Total HRQL or domain)=[(Highest possible raw score-Actual total raw score)/Raw score range]x100. Higher transformed scores indicative of better HRQL. Positive change in HRQL scores indicates improvement. Change: score at observation minus score at baseline.|Baseline, Week 4 and 12|FAS subjects with non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.||scores on scale||Standard Error|Least Squares Mean
750691|NCT00546637|Secondary|Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Per 24 Hours at Week 4 and 12|OAB-q is a self-administered, 33-item, validated questionnaire that assesses how much the subject has been bothered by selected bladder symptoms during the previous week. Each item rated by subject on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Raw scores were transformed to a score from 0-100. Once transformed, higher scores represent less favorable outcome.|Baseline, Week 4 and 12|FAS subjects with non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.||scores on scale||Standard Error|Least Squares Mean
750692|NCT00546637|Secondary|Number of Participants With Change From Baseline in Change From Baseline in UPS Per 24 Hours at Week 12.|Number of participants in 3-point category: improvement [>=1-point improvement]; no change; deterioration [>=1-point decrease], based on UPS score (rated on 3-point scale: 1=not able to hold urine; 3=able to finish what I am doing). Score change calculated as score at observation minus score at baseline; re-scaled to 3-point categorical variables.|Baseline, Week 12|FAS subjects with non-missing Baseline and Week 12 values (LOCF).||participants|||Number
750693|NCT00546637|Secondary|Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) Per 24 Hours at Week 4|Number of participants in 3-point category: improvement [>=1-point improvement]; no change; deterioration [>=1-point decrease], based on UPS score (rated on 3-point scale: 1=not able to hold urine; 3=able to finish what I am doing). Score change calculated as score at observation minus score at baseline; re-scaled to 3-point categorical variables.|Baseline, Week 4|FAS subjects with non-missing Baseline and Week 4 values.||participants|||Number
750694|NCT00546637|Secondary|Number of Participants With Change From Baseline in PPBC Per 24 Hours at Week 12|"PPBC: self-administered, single-item, validated questionnaire. Rated on a 6–point scale: subject was asked: “Which of the following statements describes your bladder condition best at the moment? 1=no problems at all; 2=some very minor problems; 3=some minor problems; 4=some moderate problems; 5=severe problems; 6=many severe problems. A post-baseline vs baseline variable with ordinal values was derived: 1=Deterioration=Difference in scores was positive; 2=No Change=Difference in scores was 0; 3=Minor Improvement=Difference in scores was -1; 4=Major Improvement=Difference in scores was ≤ 2."|Baseline, Week 12|FAS subjects with non-missing Baseline and Week 12 values (LOCF).||participants|||Number
750695|NCT00546637|Secondary|Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) Per 24 Hours at Week 4|"PPBC: self-administered, single-item, validated questionnaire. Rated on a 6–point scale: subject was asked: “Which of the following statements describes your bladder condition best at the moment? 1=no problems at all; 2=some very minor problems; 3=some minor problems; 4=some moderate problems; 5=severe problems; 6=many severe problems. A post-baseline vs baseline variable with ordinal values was derived: 1=Deterioration=Difference in scores was positive; 2=No Change=Difference in scores was 0; 3=Minor Improvement=Difference in scores was -1; 4=Major Improvement=Difference in scores was ≤ 2."|Baseline, Week 4|FAS subjects with non-missing Baseline and Week 4 values.||participants|||Number
750696|NCT00546637|Secondary|Change From Baseline in IPSS Individual Item Scores (Q1, Q2,Q3, Q4, Q5, Q6, and Q7) Per 24 Hours at Week 12|The IPSS Total Score is obtained by combining the scores of the responses to 1 though 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.|Baseline, Week 12|FAS subjects with non-missing change from Baseline to Week 12 (LOCF) were included in the analysis.||scores on scale||Standard Error|Least Squares Mean
750697|NCT00546637|Secondary|Change From Baseline in IPSS Individual Item Scores (Q1, Q2, Q3, Q4, Q5, Q6, and Q7) Per 24 Hours at Week 4|The IPSS Total Score is obtained by combining the scores of the responses to 1 though 7 component questions. Each question is scored from 0-5. Total IPSS range = 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.|Baseline, Week 4|FAS subjects with non-missing change from Baseline to Week 4 were included in the analysis.||scores on scale||Standard Error|Least Squares Mean
750698|NCT00546637|Secondary|Change From Baseline in IPSS Quality of Life (QoL) Score (Q8) Per 24 Hours at Week 4 and 12|The IPSS Total Score is obtained by combining the scores of the responses to 1 though 7 component questions. Each question is scored from 0-5. Total IPSS range = 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Score of Q8 range = 0-5 points.|Baseline, Week 4 and 12|FAS subjects with non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.||scores on scale||Standard Error|Least Squares Mean
750699|NCT00546637|Secondary|Change From Baseline in IPSS Voiding Domain (Sum Q1, Q3, Q5, and Q6) Per 24 Hours at Week 4 and 12|The IPSS Total Score is obtained by combining the scores of the responses to 1 though 7 component questions. Each question is scored from 0-5. Total IPSS range = 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Sum of Q1, Q3, Q5, and Q6 range = 0-20 points.|Baseline, Week 4 and 12|FAS subjects with non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.||scores on scale||Standard Error|Least Squares Mean
750887|NCT00554840|Primary|Change of ExpiredCO Level From Baseline|End expired carbon monoxide (CO) level change from baseline to determine participants' level of smoking reduction by treatment assignment. Larger negative values represent a greater level of smoking reduction.|Weekly for 12 weeks|Some ExpiredCO data is missing due to rater error or participant absence from that study visit.||ppm||Standard Deviation|Mean
750701|NCT00546637|Secondary|Change From Baseline in International Prostate Symptom Score (IPSS) Total Score (Sum Question 1 [Q1] to Q7) Per 24 Hours at Week 4 and 12|The IPSS Total Score is obtained by combining the scores of the responses to 1 though 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.|Baseline, Week 4 and 12|FAS subjects with non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.||scores on a scale||Standard Error|Least Squares Mean
750702|NCT00546637|Secondary|Numerical Change From Baseline in Urinary Sensation Scale (USS) Sum Rating Per 24 Hours at Week 4 and 12|The USS sum rating was defined as the total of USS ratings recorded for all micturitions over the course of a day in the bladder diary. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. USS Sum rating per 24 hours was calculated as the mean rating scores on the USS multiplied by the mean number of micturitions per 24 hours at that visit.|Baseline, Week 4 and 12|FAS subjects with non-missing change from Baseline (LOCF) were included in the analysis.||USS Sum rating per 24 hours||Standard Error|Least Squares Mean
750703|NCT00546637|Secondary|Percentage Change From Baseline in Nocturnal Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12|Nocturnal micturition-related urgency episodes were defined as micturition-related urgency episodes with USS ratings 3-5 that occurred between the time the subject went to bed and the time he or she arose to start the next day. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The percentage change at Week 4 or 12 was calculated as: 100* (Nocturnal Micturition-Related Urgency Episodes at Week 4 or 12 – Baseline)/Baseline|Baseline, Week 4 and 12|FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.||percent change||Full Range|Median
750704|NCT00546637|Secondary|Numerical Change From Baseline in Nocturnal Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12|Nocturnal micturition-related urgency episodes were defined as micturition-related urgency episodes with USS ratings 3-5 that occurred between the time the subject went to bed and the time he or she arose to start the next day. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Week 4 and 12|FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.||number of episodes||Standard Error|Least Squares Mean
750705|NCT00546637|Secondary|Percentage Change From Baseline in Severe Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12|Severe micturition-related urgency episodes are defined as those with a USS rating ≥4 marked for the corresponding micturition in the bladder diary. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The percentage change at Week 4 or 12 was calculated as: 100* (Severe Micturition-Related Urgency Episodes at Week 4 or 12 – Baseline)/Baseline|Baseline, Week 4 and 12|FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.||percent change||Full Range|Median
750706|NCT00546637|Secondary|Numerical Change From Baseline in Severe Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12|Severe micturition related urgency episodes were defined as those micturitions with USS rating >=4 marked for the corresponding micturition in the diary. USS: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Week 4 and 12|FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.||number of episodes||Full Range|Median
750707|NCT00546637|Secondary|Percentage Change From Baseline in UUI Episodes Per 24 Hours at Week 4 and 12|UUI episodes are defined as those micturitions with a USS rating of 5 in the bladder diary in subjects with UUI at baseline. USS rating 5: Unable to hold; leak urine. The percentage change at Week 4 or 12 was calculated as: 100* (UUI Episodes at Week 4 or 12 – Baseline)/Baseline|Baseline, Week 4 and 12|FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.||percent change||Full Range|Median
750708|NCT00546637|Secondary|Numerical Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 and 12|UUI episodes were defined as those micturitions with USS rating of 5 in the diary in subjects with UUI at baseline. USS rating 5: Unable to hold; leak urine.|Baseline, Week 4 and Week 12|FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.||number of episodes||Full Range|Median
750709|NCT00546637|Secondary|Percentage Change From Baseline in Nocturnal Micturitions Per 24 Hours at Week 4 and 12|Nocturnal micturitions were defined as micturitions with USS rating 1-5 that occurred between the time the subject went to bed and the time he or she arose to start the next day. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The percentage change at Week 4 or 12 was calculated as: 100* (Nocturnal micturitions at Week 4 or 12 – Baseline)/Baseline|Baseline, Week 4 and 12|FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.||percent change||Full Range|Median
750710|NCT00546637|Secondary|Numerical Change From Baseline in Nocturnal Micturitions Per 24 Hours at Week 4 and 12|Nocturnal micturitions were defined as micturitions with USS rating 1-5 that occurred between the time the subject went to bed and the time he or she arose to start the next day. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The mean number of nocturnal micturitions per 24 hours was calculated as the total number of nocturnal micturitions divided by the total number of diary days collected at that visit.|Baseline, Week 4 and 12|FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.||number of micturitions||Standard Error|Least Squares Mean
750711|NCT00546637|Secondary|Percentage Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12|All micturitions with USS rating 1 to 5. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The percentage change at Week 4 or 12 was calculated as: 100* (Micturitions at Week 4 or 12 – Baseline)/Baseline|Baseline, Week 4 and 12|FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.||percent change||Full Range|Median
750712|NCT00546637|Secondary|Numerical Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12|All micturitions with USS rating 1 to 5. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The mean number of micturitions per 24 hours was calculated as the total number of micturitions divided by the total number of diary days collected at that visit. Numeric change of micturitions per 24 hours at Week 4 and 12 relative to Baseline.|Baseline, Week 4 and 12|FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.||number of micturitions||Standard Error|Least Squares Mean
750713|NCT00546637|Secondary|Percentage Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12|"Micturition-related urgency episodes per 24 hours were defined as those with USS Scale rating of >= 3 marked for the corresponding micturition in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The percentage change at Week 4 or 12 was calculated as:
100* (Micturition-Related Urgency Episodes at Week 4 or 12 – Baseline)/Baseline"|Baseline, Week 4 and 12|FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.||percent change||Full Range|Median
750714|NCT00546637|Secondary|Numerical Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Week 4|The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS Scale >= 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Week 4|FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 were included in the analysis.||number of episodes||Standard Error|Least Squares Mean
750715|NCT00546637|Primary|Numerical Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Week 12|The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS Scale >= 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Week 12|The full analysis set (FAS) included all subjects who took at least one dose of assigned study drug and had at least one baseline or post-baseline efficacy assessment. Only FAS subjects with non-zero micturition-related urgency episodes at Baseline and non-missing change from Baseline to Week 12 (LOCF) were included in the analysis.||number of episodes||Standard Error|Least Squares Mean
750716|NCT00553436|Primary|Numbers of Participants With Successful Deployment of Tissue Apposition System (TAS)|Number of enrolled subjects (participants) treated with successful deployment of the Tissue Apposition System (TAS) device.|At The Time of Surgery|All enrolled subjects were analyzed||participants|||Number
750717|NCT00553436|Secondary|Number of Participants With Durable Tissue Appositions at Three Months Post-Endoscopic Mucosal Resection (EMR) Tissue Apposition||3 month follow-up|All enrolled subjects were analyzed||Participants|||Number
750718|NCT00553436|Secondary|Numbers of Participants With Successful Deployments of Tissue Anchors and Associated Knotting Element for Tissue Closure Post-Endoscopic Mucosal Resection (EMR) Tissue Apposition.|The total number of participants with successful deployments of tissue anchors and associated knotting elements for tissue closure post-Endoscopic Mucosal Resection (EMR) tissue apposition and achieving defect closure.|3 month follow-up|||participants|||Number
750719|NCT00553462|Secondary|Progression-free Survival|Progression free survival (PFS) is defined as the time from registration to disease progression or death of any cause, which ever comes first. The median PFS with 95% CI was estimated using the Kaplan-Meier method.|Duration of study (up to 2 years)|||months||95% Confidence Interval|Median
750720|NCT00553462|Secondary|Response Rate|"Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria:
Complete Response (CR): disappearance of all target lesions;
Partial Response (PR) 30% decrease in sum of longest diameter of target lesions;
Progressive Disease (PD): 20% increase in sum of longest diameter of target lesions;
Stable Disease (SD): small changes that do not meet above criteria.
Response rate is reported as the percentage of participants who achieved each response."|Duration of study (up to 2 years)|||percentage of participants|||Number
750721|NCT00553462|Primary|Overall Survival at 12 Months|Percentage of participants who were alive at 12 months.|At 12 months|||percentage of participants||95% Confidence Interval|Number
750722|NCT00553475|Primary|Change From Baseline at Week 13 in Mean Weekly Pain Scores|"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 13.
Change from baseline: Score at Week 13 minus score at baseline"|From baseline to Week 13|Full analysis set. Observed case (No imputation).||score on scale||Standard Error|Least Squares Mean
750723|NCT00553475|Secondary|Patient Global Impression of Change|The Patient Global Impression of Change is a patient-rated instrument that measures change in patient’s overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).|Week 13 or up to discontinuation|Full analysis set. Last observation carried forward.||score on scale||Standard Deviation|Mean
750724|NCT00553475|Secondary|Clinical Global Impression of Change|Clinical Global Impression of Change is a clinician-rated instrument that measures change in patient’s overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).|Week 13 or up to discontinuation|Full analysis set. Last observation carried forward.||score on scale||Standard Deviation|Mean
750725|NCT00553475|Secondary|Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Overall Sleep Problems Index|The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for overall sleep problems index ranges from 0-100. Higher scores indicate more of the attribute.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
750726|NCT00553475|Secondary|Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Somnolence|The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for somnolence ranges from 0-100. Higher scores indicate more of the attribute.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
750728|NCT00553475|Secondary|Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Quantity of Sleep|The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for quantity of sleep ranges from 0-24. Higher scores indicate more of the attribute named in the subscale.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
750729|NCT00553475|Secondary|Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Sleep Shortness of Breath or Headache|The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for sleep shortness of breath or headache ranges from 0-100. Higher scores indicate more of the attribute.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
750730|NCT00553475|Secondary|Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Snoring|The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for snoring ranges from 0-100. Higher scores indicate more of the attribute.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
750731|NCT00553475|Secondary|Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Sleep Disturbance|The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for sleep disturbance ranges from 0-100. Higher scores indicate more severe pain.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
750732|NCT00553475|Secondary|Change From Baseline in Short-Form McGill Pain Questionnaire: Present Pain Intensity Scores|The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Present pain intensity score ranges from 0-5. Higher scores indicate more severe pain.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
750733|NCT00553475|Secondary|Change From Baseline in Short-Form McGill Pain Questionnaire: Visual Analogue Scale Scores|The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Visual Analogue Scale Score ranges from 0-100 mm. Higher scores indicate more severe pain.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.||mm||Standard Error|Least Squares Mean
750734|NCT00553475|Secondary|Change From Baseline in Short-Form McGill Pain Questionnaire: Total Scores|The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Total score ranges from 0-45. Higher scores indicate more severe pain.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
750735|NCT00553475|Secondary|Change From Baseline in Short-Form McGill Pain Questionnaire: Affective Scores|The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Affective score ranges from 0-12. Higher scores indicate more severe pain.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
750736|NCT00553475|Secondary|Change From Baseline in Short-Form McGill Pain Questionnaire: Sensory Scores|The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Sensory score ranges from 0-33. Higher scores indicate more severe pain.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
750737|NCT00553475|Secondary|Change From Baseline in Mean Sleep Interference Scores|The mean change from baseline in the weekly mean sleep interference score at study endpoint. Score range is from 0-10. Higher scores indicate more severe interference with sleep.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
750738|NCT00553475|Secondary|Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Mental Health|The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
750739|NCT00553475|Secondary|Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Vitality|The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
750740|NCT00553475|Primary|Change From Baseline at Week 12 in Mean Weekly Pain Scores|"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 12.
Change from baseline: Score at Week 12 minus score at baseline"|From baseline to Week 12|Full analysis set. Observed case (No imputation).||score on scale||Standard Error|Least Squares Mean
750741|NCT00553475|Primary|Change From Baseline at Week 11 in Mean Weekly Pain Scores|"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 11.
Change from baseline: Score at Week 11 minus score at baseline"|From baseline to Week 11|Full analysis set. Observed case (No imputation).||score on scale||Standard Error|Least Squares Mean
750742|NCT00553475|Primary|Change From Baseline at Week 10 in Mean Weekly Pain Scores|"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 10.
Change from baseline: Score at Week 10 minus score at baseline"|From baseline to Week 10|Full analysis set. Observed case (No imputation).||score on scale||Standard Error|Least Squares Mean
750743|NCT00553475|Primary|Change From Baseline at Week 9 in Mean Weekly Pain Scores|"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 9.
Change from baseline: Score at Week 9 minus score at baseline"|From baseline to Week 9|Full analysis set. Observed case (No imputation).||score on scale||Standard Error|Least Squares Mean
750744|NCT00553475|Primary|Change From Baseline at Week 8 in Mean Weekly Pain Scores|"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 8.
Change from baseline: Score at Week 8 minus score at baseline"|From baseline to Week 8|Full analysis set. Observed case (No imputation).||score on scale||Standard Error|Least Squares Mean
750745|NCT00553475|Primary|Change From Baseline at Week 7 in Mean Weekly Pain Scores|"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 7.
Change from baseline: Score at Week 7 minus score at baseline"|From baseline to Week 7|Full analysis set. Observed case (No imputation).||score on scale||Standard Error|Least Squares Mean
750746|NCT00553475|Primary|Change From Baseline at Week 6 in Mean Weekly Pain Scores|"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 6.
Change from baseline: Score at Week 6 minus score at baseline"|From baseline to Week 6|Full analysis set. Observed case (No imputation).||score on scale||Standard Error|Least Squares Mean
750747|NCT00553475|Primary|Change From Baseline at Week 5 in Mean Weekly Pain Scores|"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 5.
Change from baseline: Score at Week 5 minus score at baseline"|From baseline to Week 5|Full analysis set. Observed case (No imputation).||score on scale||Standard Error|Least Squares Mean
750748|NCT00553475|Primary|Change From Baseline at Week 4 in Mean Weekly Pain Scores|"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 4.
Change from baseline: Score at Week 4 minus score at baseline"|From baseline to Week 4|Full analysis set. Observed case (No imputation).||score on scale||Standard Error|Least Squares Mean
750749|NCT00553475|Primary|Change From Baseline at Week 3 in Mean Weekly Pain Scores|"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 3.
Change from baseline: Score at Week 3 minus score at baseline"|From baseline to Week 3|Full analysis set. Observed case (No imputation).||score on scale||Standard Error|Least Squares Mean
750750|NCT00553475|Primary|Change From Baseline at Week 2 in Mean Weekly Pain Scores|"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 2.
Change from baseline: Score at Week 2 minus score at baseline"|From baseline to Week 2|Full analysis set. Observed case (No imputation).||score on scale||Standard Error|Least Squares Mean
750751|NCT00553475|Primary|Change From Baseline at Week 1 in Mean Weekly Pain Scores|"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 1.
Change from baseline: Score at Week 1 minus score at baseline"|From baseline to Week 1|Full analysis set. Observed case (No imputation).||score on scale||Standard Error|Least Squares Mean
750752|NCT00553475|Primary|Number of Responders|A responder is defined as a subject with a 50% reduction in weekly mean pain score from baseline to study endpoint.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.||participants|||Number
750753|NCT00553475|Primary|Change From Baseline to Study Endpoint in Mean Weekly Pain Scores by Groups of Subjects With Expected Similar Plasma Concentrations|Change from baseline: Score at study endpoint minus score at baseline. Study endpoint is defined as the mean of the last seven entries of the daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) while on study medication up to and including day after last dose. Subjects are classified by exposure to pregabalin, which is estimated by creatinine clearance (CLcr).|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
750754|NCT00553475|Secondary|Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Role Limitations-Emotional|The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
750755|NCT00553475|Secondary|Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Social Functioning|The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
750756|NCT00553475|Secondary|Change From Baseline in Short Form 36-Item (SF-36) Health Survey: General Health Perception|The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
750757|NCT00553475|Secondary|Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Bodily Pain|The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
750758|NCT00553475|Secondary|Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Role Limitations-Physical|The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
750759|NCT00553475|Secondary|Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Physical Functioning|The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
750760|NCT00553475|Primary|Change From Baseline to Study Endpoint in Mean Weekly Pain Scores|Change from baseline: Score at study endpoint minus score at baseline. Study endpoint is defined as the mean of the last seven entries of the daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) while on study medication up to and including day after last dose.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
750761|NCT00553501|Post-Hoc|3-Year Overall Survival|Percentage of participants who were alive at 3 years. The 3 year survival, with 95% confidence interval, was estimated using the Kaplan Meier method.|3 years|||percentage of participants||95% Confidence Interval|Number
750762|NCT00553501|Secondary|Progression Free Survival|Progression free survival (PFS) was defined as the time from registration to progression or death of any cause. Progression free and alive patients were censored at the date of last follow-up. The median PFS with 95% CI was estimated using the Kaplan Meier method.|Duration of study (up to 10 years)|||years||95% Confidence Interval|Median
750763|NCT00553501|Primary|Number of Participants With Overall Response|"Overall response is defined as achievement of a complete response (CR) or partial response (PR) as defined by the Revised Response Criteria for Malignant Lymphoma.
CR: complete disappearance of all detectable disease PR: >=50% decrease in the sum of the product of diameters of indicator lesions"|12 months|||participants|||Number
750764|NCT00553514|Secondary|Number of Follicles With Mean Diameter Less Than (<) 11 Millimeter (mm) and Greater Than or Equal to (>=) 11 mm||Stimulation Day 5 (S5), S7 and r-hCG administration day (end of stimulation cycle [approximately 14 days])|PP population included all the randomized participants who were without a medically relevant protocol deviation. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure. 'n' signifies number of participants who were evaluable for specified categories at different time points.||Follicles||Standard Deviation|Mean
750765|NCT00553514|Secondary|Cumulative Dose of Supplemental Follitropin Alfa Administered||Stimulation Day 7 (S7) up to r-hCG administration day (end of stimulation cycle [approximately 14 days])|PP population included all the randomized participants who were without a medically relevant protocol deviation. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.||IU||Standard Deviation|Mean
750766|NCT00553514|Secondary|Duration of Supplemental Follitropin Alfa Treatment||Stimulation Day 7 (S7) up to r-hCG administration day (end of stimulation cycle [approximately 14 days])|PP population included all the randomized participants who were without a medically relevant protocol deviation. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.||Days||Standard Deviation|Mean
750767|NCT00553514|Secondary|Duration of Ovarian Stimulation|Ovarian stimulation included from first dose of study drug on S1 until day on which r-hCG was administered (r-hCG day).|Stimulation Day 1 (S1) up to r-hCG administration day (end of stimulation cycle [approximately 14 days])|PP population included all the randomized participants who were without a medically relevant protocol deviation. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.||Days||Standard Deviation|Mean
750768|NCT00553514|Secondary|Percentage of Participants With Clinical Pregnancy|Clinical pregnancy was defined as the presence of one or more fetal sacs with fetal heart activity on the Day 35-42 post r-hCG ultrasound examination.|Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])|PP population included all the randomized participants who were without a medically relevant protocol deviation. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.||Percentage of participants|||Number
750769|NCT00553514|Primary|Percentage of Participants With Ovulation|Ovulation was defined as a mid-luteal phase progesterone (P4) level >= 30 nanomole per liter (nmol/L) (10 nanogram per milliliter [ng/mL]). In the absence of a positive progesterone response, clinical pregnancy was also considered as evidence of ovulation.|Mid-luteal phase progesterone assessed 5-10 days or clinical pregnancy 35-42 days after recombinant human chorionic gonadotropin (r-hCG) administration day (end of stimulation cycle [approximately 14 days])|Per Protocol (PP) population included all the randomized participants who were without a medically relevant protocol deviation. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.||Percentage of participants|||Number
750770|NCT00553605|Secondary|Number of Participants With Use of Rescue Medication (RM)|Rescue medications included intravenous 0.1 to 0.2 mg/kilogram (kg) of morphine or 1 mg/kg of pethidine or muscle relaxants.|Up to Minute 120|mITT included all randomized participants who received at least 1 dose of the study drug with at least 1 post-baseline pain assessment.||participants|||Number
750771|NCT00553605|Secondary|Physician’s Global Evaluation of Study Medication|Physicians’ response to the question “How would you rate the study medication the patient received for pain?” on a 4-point categorical scale, 1=Poor, 2= Fair, 3=Good, 4=Excellent was evaluated.|Minute 30, 120|mITT included all randomized participants who received at least 1 dose of the study drug with at least 1 post-baseline pain assessment. Here ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure.||participants|||Number
750772|NCT00553605|Secondary|Patient’s Global Evaluation of Study Medication|"Participants' response to the question How would you rate the study medication you received for pain?” on a 4-point categorical scale, 1=Poor, 2= Fair, 3=Good, 4=Excellent was evaluated."|Minute 30, 120|mITT included all randomized participants who received at least 1 dose of the study drug with at least 1 post-baseline pain assessment. Here ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure.||participants|||Number
750773|NCT00553605|Secondary|Number of Participants With Response in Pain Intensity|PI-VAS assessed with response to the question “How much pain are you having right now?” on a 100 mm line, with 0 mm=no pain, 100 mm= worst possible pain. Responders were those who had a decreased in VAS of at least 20 mm.|Minute 30|mITT included all randomized participants who received at least 1 dose of the study drug with at least 1 post-baseline pain assessment. Here ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure.||participants|||Number
750785|NCT00553631|Secondary|Change From Baseline to Month 9 in Normalized Liver Volume (Percent (%) Body Weight) for Each Treatment Group.|Values shown are observed change from Baseline to Month 9. Measured by Magnetic resonance imaging (MRI). Liver volume has been normalized for percent (%) body weight for each treatment arm. Liver size relative to body weight = (Liver volume [cubic centimeter (cc)]/Body weight [kg]*1000.|Baseline to Month 9|ITT population.||cubic centimeter (cm^3)||Standard Error|Mean
750774|NCT00553605|Secondary|Number of Participants With Pain Relief (PR)|PR was assessed on a 5-point categorical pain relief rating scale wherein 0= None, 1= a little, 2= Some, 3= a lot and 4= Complete relief.|Minute 30, 120|mITT included all randomized participants who received at least 1 dose of the study drug with at least 1 post-baseline pain assessment. Here ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specific time point for each treatment arm respectively.||participants|||Number
750775|NCT00553605|Secondary|Time-weighted Sum of Pain Relief Score Over 120 Min (TOTPAR120min)|TOTPAR: time-weighted sum of Pain Relief (PR) over 120 min. TOTPAR score range was 0 (worst) to 480 (best). PR was assessed on a 5-point categorical pain relief rating scale wherein 0=No relief to 4=Complete relief.|Baseline through Minute 120|mITT included all randomized participants who received at least 1 dose of the study drug with at least 1 post-baseline pain assessment. Here ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure.||units on a scale||Standard Error|Least Squares Mean
750776|NCT00553605|Secondary|Time-specific Pain Intensity Difference (PID) at Minute 15, 30, 45, 60, 90 and 120|PID score was obtained by subtracting the PI-VAS at each time point from baseline PI score. PI-VAS assessed with response to the question “How much pain are you having right now?” on a 100 mm line, with 0 mm=no pain, 100 mm= worst possible pain. PID score ranged from -100 to 100. Positive score= improved response in pain.|Baseline, Minute 15, 30, 45, 60, 90, 120|mITT included all randomized participants who received at least 1 dose of the study drug with at least 1 post-baseline pain assessment. Here ‘n’ signifies participants who were evaluable at specific time points for each treatment arm respectively.||mm||Standard Deviation|Mean
750777|NCT00553605|Secondary|Time-specific Pain Intensity (PI) VAS Score|PI-VAS assessed with response to the question “How much pain are you having right now?” on a 100 mm line, with 0 mm=no pain, 100 mm= worst possible pain.|Baseline, Minute 15, 30, 45, 60, 90, 120|mITT included all randomized participants who received at least 1 dose of the study drug with at least 1 post-baseline pain assessment. Here ‘n’ signifies participants who were evaluable at specific time point for each treatment arm respectively.||mm||Standard Deviation|Mean
750778|NCT00553605|Secondary|Mean Pain Intensity Difference at 120 Min (mPID120min)|mPID score was obtained by summation of product of length of the interval and difference in pain intensity (PI) divided by summation of length of the interval. Summation was done from zero to 120 minutes. Difference in pain intensity was obtained by subtracting the Pain Intensity Visual Analogue Scale (PI-VAS) at Minute 120 from baseline PI-VAS score. PI-VAS assessed with response to the question “How much pain are you having right now?” on a 100 millimeter (mm) line, with 0 mm=no pain, 100 mm= worst possible pain. mPID score ranged from -100 to 100. Positive score= improved response in pain.|Minute 120|Modified intent- to-treat (mITT) included all randomized participants who received at least 1 dose of the study drug with at least 1 post-baseline pain assessment.||mm||Standard Error|Least Squares Mean
750779|NCT00553605|Primary|Mean Pain Intensity Difference at 30 Minutes (mPID30min)|mPID score was obtained by summation of product of length of the interval and difference in pain intensity (PI) divided by summation of length of the interval. Summation was done from zero to 30 minutes. Difference in pain intensity was obtained by subtracting the Pain Intensity Visual Analogue Scale (PI-VAS) at Minute 30 from baseline PI-VAS score. PI-VAS assessed with response to the question “How much pain are you having right now?” on a 100 millimeter (mm) line, with 0 mm=no pain, 100 mm= worst possible pain. mPID score ranged from -100 to 100. Positive score= improved response in pain.|Minute 30|Per-protocol (PP): all randomized participants who received at least 1 dose of study drug; had 1 post-baseline pain assessment; no major protocol violations; received appropriate dose of study drug; had valid baseline, 15 and 30 min VAS pain assessments; did not take rescue medications for 30 min; had confirmed diagnosis of nephrolithiasis.||mm||Standard Error|Least Squares Mean
750780|NCT00553631|Secondary|Time to Response- Comparison of GA-GCB and Imiglucerase on the Earliest Time to Respond as Assessed Via Hemoglobin Concentration|Time to response was defined as a ≥ 1 g/dL improvement in hemoglobin levels relative to Baseline. Units (%) correlates to the percentage of participants who had a change of ≥ 1 g/dL improvement in hemoglobin levels relative to Baseline during their participation in the study.|Response rate at Month 9 compared to Baseline|ITT population||Percentage of participants|||Number
750781|NCT00553631|Secondary|Number of Participants Who Developed Antibody for Each Treatment Group.|Measure type is actual number of participants who developed antibodies to treatment; GA-GCB or imiglucerase. Antibody detection was based upon serum samples collected at various time points throughout the study. Serum samples were screened using an enzyme-linked immunosorbent assay (ELISA) and positive antibody confirmation was determined using a radioimmunoprecipitation assay (RIP); positive samples were also tested for enzyme neutralizing activity. Participant samples were compared to internal assay controls (positive/negative), positive samples were determined based upon individual assay criteria.|Baseline to Month 9|Safety population comprised of all randomized participants who received at least 1 full or partial dose of study drug.||participants|||Number
750782|NCT00553631|Secondary|Change From Baseline to Month 9 in Plasma Chemokine (C-C Motif) Ligand 18 (CCL18) for Each Treatment Group.|Values shown are observed change from Baseline to Month 9.|Baseline to Month 9|ITT population.||nanogram per milliliter (ng/mL)||Standard Error|Mean
750783|NCT00553631|Secondary|Change From Baseline to Month 9 in Plasma Chitotriosidase for Each Treatment Group.|Values shown are observed change from Baseline to Month 9. Units of measure is defined as nanomole per milliliter per hour.|Baseline to Month 9.|ITT population. Number of participants analyzed signifies participants evaluable for this outcome. Chitotriosidase levels were measured in 10 participants in the velaglucerase alfa group and 11 participants in the imiglucerase group.||nanomole/milliliter/hour (nmol/mL/h)||Standard Error|Mean
750784|NCT00553631|Secondary|Change From Baseline to Month 9 in Normalized Spleen Volume (Percent (%) Body Weight) for Each Treatment Group.|Values shown are observed change from Baseline to month 9. Measured by Magnetic resonance imaging (MRI). Spleen volume was normalized for percent (%) of body weight for each treatment arm. Spleen size relative to body weight=(Spleen volume [cc]/Body weight [kg])*100.|Baseline to Month 9|ITT population. Number of participants analyzed signifies participants evaluable for this outcome. Ten participants in each treatment group underwent splenectomy, and therefore, were excluded from the analysis.||cm^3||Standard Error|Mean
750786|NCT00553631|Secondary|Change From Baseline to Month 9 in Platelet Counts for Each Treatment Group.|Values shown are observed change from Baseline to Month 9.|Baseline to Month 9|ITT population.||10^9 per liter (10^9/L)||Standard Error|Mean
750791|NCT00553644|Primary|Number of Participants With an Overall Response Defined as Complete Response and Partial Response|"Response is assessed by investigator according to International Working Group (IWG) criteria.
A complete response requires disappearance of all evidence of disease. A partial response is a >/= 50% decrease in the sum of products of 6 largest dominant nodes or nodal masses as well as for splenic and hepatic nodules. No increase in size of nodes, liver or spleen and no new sites of disease."|Duration of treatment (assessed up to 6 years)|||participants|||Number
750792|NCT00553696|Secondary|Time to Progression (TTP)|Time in months from enrollment to first documentation of objective tumor progression. TTP was calculated as (first event date or last known progression-free date minus the date of enrollment plus 1 day). Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD] per RECIST).|Baseline up to 739 days|Full Analysis Set consisted of all participants enrolled in the study who received at least 1 dose of study medication (cisplatin, S-1 or sunitinib).||Months||95% Confidence Interval|Median
750793|NCT00553696|Secondary|Progression-Free Survival (PFS)|Median time from the enrollment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first. PFS calculated as (first event date minus enrollment date plus 1 day)|Baseline up to 739 days|Full Analysis Set consisted of all participants enrolled in the study who received at least 1 dose of study medication (cisplatin, S-1 or sunitinib).||Months||95% Confidence Interval|Median
750794|NCT00553696|Secondary|Duration of Response (DR)|Time from the first objective documentation of tumor response (confirmed or partial response) to first documented objective tumor progression or death due to cancer. DR calculated as (the end date for DR minus first subsequent confirmed CR or PR plus 1 day).|Baseline up to 739 days|A subgroup of participants with an objective tumor response among Full Analysis Set consisted of all participants enrolled in the study who received at least 1 dose of study medication (cisplatin, S-1 or sunitinib)||Months||95% Confidence Interval|Median
750795|NCT00553696|Secondary|Number of Participants With Clinical Benefit Response (CBR)|CBR is defined as a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) for at least 24 weeks on study according to RECIST. Confirmed responses are those that persist on repeat imaging at least 4 weeks after initial documentation of response.|Baseline up to 739 days|Full Analysis Set consisted of all participants enrolled in the study who received at least 1 dose of study medication (cisplatin, S-1 or sunitinib).||participants|||Number
750796|NCT00553696|Secondary|Number of Participants With Objective Response|Number of participants with objective response-based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as the disappearance of all target lesions. PR defined as greater than or equal to (≥) 30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. Confirmed responses are those that persist on repeat imaging at least 4 weeks after initial documentation of response.|Baseline up to 739 days|Full Analysis Set consisted of all participants enrolled in the study who received at least 1 dose of study medication (cisplatin, S-1 or sunitinib)||participants|||Number
750797|NCT00553696|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Total Platinum and Free Platinum|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|Day 1 of Cycles 1 and 2 (pre-dose, 0.5, 1, 2, 8, and 22 hours after completing infusion)|Participants who received cisplatin and had sufficient plasma concentration data for calculation of pharmacokinetic parameters||ng*h/mL||Standard Deviation|Mean
750798|NCT00553696|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Total Platinum and Free Platinum||Day 1 of Cycles 1 and 2 (pre-dose, 0.5, 1, 2, 8, and 22 hours after completing infusion)|Participants who received cisplatin and had sufficient plasma concentration data for calculation of pharmacokinetic parameters||hrs||Full Range|Median
750799|NCT00553696|Secondary|Maximum Observed Plasma Concentration (Cmax) of Total Platinum and Free Platinum||Day 1 of Cycles 1 and 2 (pre-dose, 0.5, 1, 2, 8, and 22 hours after completing infusion)|Participants who received cisplatin and had sufficient plasma concentration data for calculation of pharmacokinetic parameters||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
750800|NCT00553696|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Tegafur and 5-FU|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|Day 1 of Cycles 1 and 2 (pre-dose, 1, 2, 4, 6, 8, and 10 hours post-dose)|Participants who received S-1 and had sufficient plasma concentration data for calculation of pharmacokinetic parameters||ng*h/mL||Standard Deviation|Mean
750801|NCT00553696|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Tegafur and 5-FU||Day 1 of Cycles 1 and 2 (pre-dose, 1, 2, 4, 6, 8, and 10 hours post-dose)|Participants who received S-1 and had sufficient plasma concentration data for calculation of pharmacokinetic parameters||hrs||Full Range|Median
750802|NCT00553696|Secondary|Maximum Observed Plasma Concentration (Cmax) of Tegafur and 5-FU||Day 1 of Cycles 1 and 2 (pre-dose, 1, 2, 4, 6, 8, and 10 hours post-dose)|Participants who received S-1 and had sufficient plasma concentration data for calculation of pharmacokinetic parameters||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
750803|NCT00553696|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Sunitinib, SU-012662, and Total Drug (Sunitinib + SU-012662)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|Day 1 of Cycles 1 and 2 (pre-dose, 2, 4, 6, 8, 10, and 24 hours post-dose)|Participants who received Sunitinib and had sufficient plasma concentration data for calculation of pharmacokinetic parameters||ng*h/mL||Standard Deviation|Mean
750804|NCT00553696|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Sunitinib, SU-012662, and Total Drug (Sunitinib + SU-012662)||Day 1 of Cycles 1 and 2 (pre-dose, 2, 4, 6, 8, 10, and 24 hours post-dose)|Participants who received Sunitinib and had sufficient plasma concentration data for calculation of pharmacokinetic parameters||hrs||Full Range|Median
750805|NCT00553696|Secondary|Maximum Observed Plasma Concentration (Cmax) of Sunitinib, SU-012662, and Total Drug (Sunitinib + SU-012662)||Day 1 of Cycles 1 and 2 (pre-dose, 2, 4, 6, 8, 10, and 24 hours post-dose)|Participants who received Sunitinib and had sufficient plasma concentration data for calculation of pharmacokinetic parameters||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
754765|NCT00586326|Secondary|Cosmetic Evaluations Over Time|As assessed using the four category Harvard Scale for subjects with an evaluation at the 5 year timepoint|At 5 Years|Subjects with Cosmetic Evaluation at 5 Years||percentage of subjects|||Number
750806|NCT00553696|Primary|Number of Participants With First Cycle Dose-limiting Toxicities (DLTs)|A DLT is any of a predefined set of unacceptable adverse events, regardless of cause. DLTs were assessed during the first cycle (4 weeks).|Cycle 1 (Baseline to Week 4)|DLT Evaluation Set consisted of participants who were initially enrolled for the determination of maximam tolerated dose (MTD), and either 'experienced DLT' or 'received all of the Day 1 chemotherapy, received at least 80% of their sunitinib doses, and at least 80% of S-1 doses'.||participants|||Number
750807|NCT00553969|Primary|Change in Disease Score (DS) Among the Treatment Groups|Rasmussen Disease Score (RDS) Change From Baseline to 9 Months A score of six or higher on these tests means the patient likely has plaque build-up in the arteries, or atherosclerosis, while a score of three to five suggests that such a problem may be developing. A score of two or less signals a patient is fine but should return in the future for another test. The method detects disease at the earliest moment, before the traditionally used calcium score would show any signs of trouble.|Baseline and nine months|Calculation for change is the value at the later time point minus the value at the earlier time point.||Overall Rasmussen Disease Score Change||Standard Deviation|Mean
750808|NCT00553969|Secondary|Quantitative Change in Each of the RDS Components From Baseline to 9 Months Will Serve as a Secondary End-point. The 3-month Data Will Provide Early Evidence for Drug Efficacy and Will be Analyzed Similarly as a Secondary End-point.||3-9 months||||||
750809|NCT00553969|Primary|The Overall Rasmussen Disease Score (RDS) Change From Baseline to 9 Months Will be the Primary End-point.||9 months||||||
750810|NCT00554099|Secondary|Recurrent Diverticulitis, Percentage, ITT Population, Week 52|At least one report of recurrent diverticulitis since the last visit (prior to the Week 52 visit).|52 Weeks|ITT Population||Percentage of Participants|||Number
750811|NCT00554099|Secondary|Recurrent Diverticulitis, Percentage, ITT Population, Week 12|At least one report of recurrent diverticulitis since the last visit (prior to the Week 12 visit).|12 Weeks|ITT Population||Percentage of Participants|||Number
750812|NCT00554099|Secondary|Withdrawal Due to Surgery for Diverticulitis, Percentage, ITT Population, Week 12||12 Weeks|ITT Population||Percentage of Participants|||Number
750813|NCT00554099|Secondary|Change in GSS From Baseline to Week 52 - ITT Population|GSS - Abdominal Pain & Symptom Rating, scale 0-none (better) to 6-severe (worse) for each of the following categories: abdominal pain, abdominal tenderness, nausea/vomiting, bloating, constipation, diarrhea, mucus in stool, feeling urge to evacuate but no bowel movement, painful straining with bowel movement, pain/difficulty urinating. Total minimum score 0 (better), total maximum score 60 (worse).|Baseline to Week 52|ITT Population||Scores on a Scale||Standard Error|Mean
750814|NCT00554099|Secondary|Change in GSS From Baseline to Week 12 - ITT Population|GSS - Abdominal Pain & Symptom Rating, scale 0-none (better) to 6-severe (worse) for each of the following categories: abdominal pain, abdominal tenderness, nausea/vomiting, bloating, constipation, diarrhea, mucus in stool, feeling urge to evacuate but no bowel movement, painful straining with bowel movement, pain/difficulty urinating. Total minimum score 0 (better), total maximum score 60 (worse).|Baseline to Week 12|ITT Population||Scores on a Scale||Standard Error|Mean
750815|NCT00554099|Secondary|Percentage of Responders at Week 52 - ITT Population|Responder - patient whose GSS scores for all symptoms were either 0 or 1 GSS - Abdominal Pain & Symptom Rating, scale 0-none (better) to 6-severe (worse) for each of the following categories: abdominal pain, abdominal tenderness, nausea/vomiting, bloating, constipation, diarrhea, mucus in stool, feeling urge to evacuate but no bowel movement, painful straining with bowel movement, pain/difficulty urinating. Total minimum score 0 (better), total maximum score 60 (worse).|52 Weeks|ITT Population||Percentage of Participants|||Number
750816|NCT00554099|Secondary|Percentage of Responders at Week 12 - ITT Population|Responder - patient whose GSS scores for all symptoms were either 0 or 1 GSS - Abdominal Pain & Symptom Rating, scale 0-none (better) to 6-severe (worse) for each of the following categories: abdominal pain, abdominal tenderness, nausea/vomiting, bloating, constipation, diarrhea, mucus in stool, feeling urge to evacuate but no bowel movement, painful straining with bowel movement, pain/difficulty urinating. Total minimum score 0 (better), total maximum score 60 (worse).|12 Weeks|ITT Population||Percentage of Participants|||Number
750817|NCT00554099|Primary|Global Symptom Score (GSS) at Week 12, Primary Efficacy Population|GSS - Abdominal Pain & Symptom Rating, scale 0-none (better) to 6-severe (worse) for each of the following categories: abdominal pain, abdominal tenderness, nausea/vomiting, bloating, constipation, diarrhea, mucus in stool, feeling urge to evacuate but no bowel movement, painful straining with bowel movement, pain/difficulty urinating. Total minimum score 0 (better), total maximum score 60 (worse).|12 Weeks|Primary Efficacy Population - Subset of ITT population including only patients with GSS value at Week 12 and baseline GSS of at least 12.||Scores on a Scale||Standard Error|Mean
750818|NCT00554190|Primary|Number of Participants With Solicited and Recorded Adverse Events|All reported events were coded to a standard set of terms using the MedDRA adverse event dictionary. Adverse events were listed and summarized.|Post-operative through 60 days|There were 19 participants who completed the 60 day follow up visits for analysis.||Participants|||Number
750819|NCT00554190|Primary|Number of Participants With Adhesion as Measured by the Synechia (Adhesion) Scale|Synechia (adhesion) scale range of 0 = No visible synechia to 3 = Complete scarring between the middle turbinate and lateral nasal wall was used in the assessment.|Post-operative through 60 days|There were 19 participants that completed the final follow-up visit at 60 days.||Participants|||Number
750820|NCT00554216|Primary|Percentage of Subjects With at Least 5% Weight Loss at Week 56||baseline to 56 weeks|intent-to-treat last-observation-carried-forward (ITT-LOCF)||percentage of participants|||Number
750821|NCT00554216|Primary|Percent Weight Loss From Baseline to Week 56||baseline to 56 weeks|intent-to-treat last-observation-carried-forward (ITT-LOCF)||percent weight loss||Standard Error|Least Squares Mean
750822|NCT00554229|Secondary|Pharmacokinetic Characteristics of ZD4054||PK samples were performed at randomisation, Week 4, Week 8 and Week 12||||||
750823|NCT00554229|Secondary|Time to Initiation of Chemotherapy|Median time (in months) from randomisation to first administration of any chemotherapy using the Kaplan-Meier method|Patients were assessed every 12 weeks|||Months||Inter-Quartile Range|Median
750986|NCT00555425|Secondary|Patient Satisfaction|Patient satisfaction as measured by survey. Primary Care Buprenorphine Satisfaction Scale (PCBSS). Comprises of 19 items evaluating satisfaction with staff expertise, concern, and responsiveness. Range of scores from 15-95. I higher score indicates greater satisfaction.|18 weeks|Results are provided on those individuals who completed this assessment||units on a scale||95% Confidence Interval|Mean
750824|NCT00554229|Secondary|Time to Pain Progression|Median time (in months) from randomisation to first assessment of an increased pain event, where increased pain event is defined as the first of a patient requiring opiate medication for duration of ≥1 week for pain due to prostate cancer metastasis, pain due to metastasis that has an increase in the worst pain item of the Brief Pain Inventory (BPI) from baseline to a minimum score of 5 with no decrease in analgesic use, or pain due to metastasis requiring radionuclide therapy, radiation therapy or surgery.|Patients were assessed every 12 weeks|||Months||Inter-Quartile Range|Median
750825|NCT00554229|Secondary|Time to Prostate-specific Antigen (PSA) Progression|Median time (in months) from randomisation to first PSA value >50% higher than baseline of at least 5ng/ml seen in at least 2 consecutive PSA values at least 2 weeks apart using the Kaplan-Meier method.|Patients were assessed every 12 weeks|||Months||Inter-Quartile Range|Median
750826|NCT00554229|Secondary|Health Related Quality of Life|Median time (in months) from randomisation until deterioration of Health related Quality of Life using the Kaplan-Meier method, where deterioration is defined as a change from baseline of less than or equal to -6 points in Total FACT-P score maintained for 2 consecutive visits.|Patients were assessed at every visit|||Months||Inter-Quartile Range|Median
750827|NCT00554229|Secondary|Bone Metastases Formation|Median time (in months) from randomisation to appearance of ≥4 new bone lesions using the Kaplan-Meier method|Patients were assessed every 12 weeks|||Months||Inter-Quartile Range|Median
750828|NCT00554229|Secondary|Incidence of Skeletal Related Events|Median time (in months) from randomisation until occurrence of a skeletal related event, where skeletal related event is defined as the first occurrence of a pathological fracture, a vertebral compression fracture not related to trauma, prophylactic surgery or radiation for impending fracture or spinal cord compression, or a spinal cord compression, using the Kaplan-Meier method.|From date of randomization until occurrence of a skeletal related event, assessed up to 31 months|||Months||Inter-Quartile Range|Median
750829|NCT00554229|Secondary|Time to Use of Opiates|Median time (in months) from randomisation until use of opiates for disease-related symptoms for a duration ≥1 week using the Kaplan-Meier method|From date of randomization until use of opiates for disease-related symptoms for a duration ≥1 week, assessed up to 31 months|||Months||Inter-Quartile Range|Median
750830|NCT00554229|Secondary|Progression Free Survival|Median time (in months) from randomisation until clinical progression of disease, where progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline, using the Kaplan-Meier method|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 31 months|||Months||Inter-Quartile Range|Median
750831|NCT00554229|Primary|Overall Survival|Median time (in months) from randomisation until death using the Kaplan-Meier method|From date of randomization until date of death, assessed up to 32 months|||months||Full Range|Median
750832|NCT00554294|Secondary|Parameters of Process Evaluation (Acceptance, Feasibility)||1,5 years||||||
750833|NCT00554294|Secondary|Water Flow of the Water Dispensers||one school year||||||
750834|NCT00554294|Secondary|Physical Activity and Inactivity||one school year||||||
750835|NCT00554294|Secondary|Intake of Drinks||one school year||||||
750836|NCT00554294|Primary|Overweight|Prevalence of overweight defined acording to the criteria of the International Obesity Task Force (IOTF)|one school year|||participants|||Number
750837|NCT00554372|Secondary|Median Overall Survival|Overall survival after treatment in days|To 760 days post treatment|||days||95% Confidence Interval|Median
750838|NCT00554372|Secondary|Number of Subjects Achieving Disease Control as Determined Using Intrahepatic Modified RECIST Criteria|"Number of subjects achieving disease control (non-progressive disease) at 8 weeks after treatment was initiated based on modified Response Evaluation Criteria in Solid Tumors for Hepatocellular Carcinoma (mRECIST for HCC). mRECIST for HCC adopted the concept of viable tumor as tumor tissue showing uptake in arterial phase of contrast enhanced radiologic imaging techniques. (see Lencioni and Llovet, Semin. Liver Dis. 2010; 30:52-60). Per mRECIST for HCC, for target lesions as assessed by contrast enhanced dynamic MRI: Complete Response (CR), Disappearance of any intratumoral arterial enhancement in all target (viable) lesions; Partial Response (PR), >=30% decrease in the sum of diameters of viable target lesions; Stable Disease (SD), any cases that do not qualify for PR or progressive disease (PD); PD, any increase of >= 20% in viable target lesions.
Disease Control (DC) = CR or PR or SD."|At week 8|||participants|||Number
750839|NCT00554372|Secondary|Safety and Tolerability of JX-594 Administered at Two Dose Levels|Treatment-related serious adverse events in patients treated at two dose levels|Safety and tolerability were evaluated throughout the 8 week period of study participation|||serious adverse event|||Number
750840|NCT00554372|Primary|Proportion of Subjects Achieving Disease Control (Non-progressive Disease) at 8 Weeks After Initiation of Treatment|Proportion of subjects achieving disease control at 8 weeks based on a modified Response Evaluation Criteria in Solid Tumors v1.0 (mRECIST). Per mRECIST for target lesions as assessed by dynamic contrast enhanced dynamic MRI: Complete Response (CR), Disappearance of all tumor(s); Partial Response (PR), >=30% decrease in the sum of longest diameter (LD) of tumor(s) taking as reference the baseline sum; Stable Disease (SD), any cases that do not qualify for PR or progressive disease (PD); PD, any increase of >= 20% in the sum of longest diameter (LD) of tumor(s) taking as reference the baseline sum. Disease Control (DC) = CR or PR or SD. For mRECIST criteria, new tumor(s) that developed within the liver were measured (a new tumor was defined as a malignant tumor not present at baseline, was ≥ 1 cm in LD had typical hypervascular features of HCC). Their maximum diameter(s) were included in the sum of the maximum diameter; new tumors were not considered evidence for progression.|Initial progression status and response assessment at 8 weeks from first dose|Patients having evaluable radiographic imaging, 2 patients in each arm were excluded due to unevaluable images, 1 patient in the low dose arm was excluded due to a protocol deviation||Proportion of evaluable participants||95% Confidence Interval|Number
750841|NCT00554463|Secondary|Median and 2-year Rates of Progression-free and Overall Survival||After all patients have been potentially followed for 2 years||||||
750842|NCT00554463|Secondary|Incidence of Grade 4 Thrombocytopenia||At the completion of all treatment, approximately 80 days||||||
750843|NCT00554463|Secondary|Incidence of Esophagitis, Pneumonitis, and Other Non-hematological Adverse Events as Assessed by NCI CTCAE v 3.0||At the completion of all treatment, approximately 80 days||||||
751005|NCT00555620|Secondary|Progression-Free Survival (PFS)|PFS defined as time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first.|Baseline up to Month 15|Efficacy analysis subset of population of participants who had an event||months||95% Confidence Interval|Median
750865|NCT00554619|Primary|Number of Participants With Adverse Events Categorized by Severity|The severity of adverse events was assessed by the investigator; events were assigned to one of the following categories: mild, an event that was easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities; moderate, an event that was sufficiently discomforting to interfere with normal everyday activities; and severe, an event that prevented normal everyday activities.|For 140.57 weeks at maximum, starting from Week 24|Safety Population||participants|||Number
750866|NCT00554619|Secondary|Mean Change From Baseline in B-type Natriuretic Peptide (BNP) Values at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion|Change from baseline was calculated as each value at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion minus the baseline value. BNP is a surrogate marker of heart failure and was measured by a central laboratory. Observed data analysis (no imputation techniques).|Baseline and Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion (up to Week 164.14)|FAS. Participants were followed for different lengths of time; thus, not all participants were analyzed at all study weeks.||nanograms per liter (ng/L)||Standard Deviation|Mean
750867|NCT00554619|Secondary|Mean Change From Baseline in Cardiac Output (CO) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion|CO is a measure of cardiopulmonary hemodynamics (echocardiography). Change from baseline was calculated as each value at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion minus the baseline value. Observed data analysis (no imputation technique).|Baseline and Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion (up to Week 156.14)|FAS. Participants were followed for different lengths of time; thus, not all participants were analyzed at all study weeks.||Liters per minute (L/min)||Standard Deviation|Mean
750868|NCT00554619|Secondary|Mean Change From Baseline in Mean Pulmonary Artery Pressure (mPAP) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion|mPAP is a measure of cardiopulmonary hemodynamics (echocardiography). Change from baseline was calculated as each value at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion minus the baseline value. Observed data analysis (no imputation technique).|Baseline and Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion (up to Week 153)|FAS. Participants were followed for different lengths of time; thus, not all participants were analyzed at all study weeks.||millimeters of mercury (mmHg)||Standard Deviation|Mean
750869|NCT00554619|Secondary|Number of Participants With the Indicated Event, as an Assessment of Time to Clinical Worsening of Pulmonary Arterial Hypertension (PAH), Assessed as the First Occurrence of a Particular Event|Time to clinical worsening was defined as the time from baseline to the first occurrence of death, lung transplantation, hospitalization for PAH treatment, atrial septostomy (a surgical procedure in which a small hole is made in the wall between the left and right atria of the heart), or study discontinuation due to change to other PAH treatment. Time to clinical worsening was measured as the number of participants who experienced these events up to 164.14 weeks.|Up to 164.14 weeks|FAS||participants|||Number
750870|NCT00554619|Secondary|Number of Participants With the Indicated Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion|There are four grades for the WHO FC (Class I = none, Class IV = most severe). The WHO FC indicates the severity of Pulmonary Arterial Hypertension and is an adaptation of the New York Heart Association classification. It was assessed by the investigator. Observed data analysis (no imputation technique).|Baseline and Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion (up to Week 164.14)|FAS. Participants were followed for different lengths of time; thus, not all participants were analyzed at all study weeks.||participants|||Number
750888|NCT00554853|Secondary|Rheumatoid Arthritis Disease Activity|"Quantification of disease activity using validated assessments (disease activity score on 28 joints (DAS28) and and C-reactive protein ( CRP) (Inflammatory marker) as a combined score (DAS-28CRP)).
Mean decrease in DAS-28-CRP score when compared to baseline was measured. The range of DAS-28-CRP is 0-10, with 0 meaning no active disease detected and 10 being the most severe active disease detected by joint count and C-reactive protein levels in blood."|8 mo|||mean decrease in DAS28-CRP score||Standard Deviation|Mean
750871|NCT00554619|Secondary|Mean Change From Baseline in the Borg Dyspnea Index (BDI) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion|The BDI was calculated by using a 10-point scale (0 = None, 10 = Maximum) and indicates the degree of breathlessness after completion of the 6-minute walk test. The BDI scale was assessed by each participant. Change from baseline was calculated as each value at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion minus the baseline value. Observed data analysis (no imputation technique).|Baseline and Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion (up to Week 159.85)|FAS. Participants were followed for different lengths of time; thus, not all participants were analyzed at all study weeks.||scores on a scale||Standard Deviation|Mean
750872|NCT00554619|Secondary|Mean Change From Baseline in Six Minutes Walk Distance (6MWD) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, and 156|Change from baseline was calculated as each value at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, and 156 minus the baseline value. 6MWD was measured by a 6-minute walk test. This test measures the distance that a participant can walk in a period of 6 minutes. Imputation technique was last observation carried forward, which was used in an attempt to compensate for missing data. For each participant, missing values were replaced with the last observed value.|Baseline and Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, and 156|Full Analysis Set (FAS): All participants registered, with the exception of those who did not receive any dose of the investigational product and those who had no efficacy assessment after treatment.||meters||Standard Deviation|Mean
750873|NCT00554619|Primary|Number of Participants With Any Adverse Event|An adverse event was defined as any untoward medical occurrence in a participant, temporally associated with the use of an investigational product, whether or not considered related to the investigational product.|For 140.57 weeks at maximum, starting from Week 24|Safety Population: Participants who had received at least one dose of the investigational product||participants|||Number
750874|NCT00554671|Primary|Hemoglobin A1c|hemoglobin A1c|13 months|||percent Hemoglobin A1c||Standard Deviation|Mean
750875|NCT00554671|Secondary|Health-care Costs to the VHA|Institutional costs from health service utilization on the study patients during and 13 months after the intervention|13 months (during study) and 13 months (after the study) = 26 months||04/2015||||
750876|NCT00554671|Secondary|Change From the Baseline in the Hr-QOL as Assessed by SF-36V at 13 Months of Study Enrollment||13 months||04/2015||||
750877|NCT00554671|Primary|Hemoglobin A1c||6 months|||percent Hemoglobin A1c||Standard Deviation|Mean
750878|NCT00554749|Secondary|Number of Children Who Obtained the Different Treatment Modules (Level of Speaking;Level 1 Through to 6)|6 Predefined treatment goals reflecting speaking levels from 1 through to 6. 1: Speaks to the therapist(T) in a separate room in the kindergarten with parent (P) present. 2: Speaks to T in a separate room without P. 3: Speaks to a teacher in a separate room with T present. 4: Speaks to other teachers in a separate room with T present. 5: Speaks to teachers in some kindergarten settings without T present. 6: Speaks to teachers in all settings in kindergarten without T present. Each child receives one score at end of treatment according to their acquired level (worst value=1, best value =6)|6 months|All participants analyzed||participants|||Number
750879|NCT00554749|Primary|School Speech Questionnaire (SSQ)|SSQ is a teacher-report measure assessing the frequency of the child's speaking behaviour at school. It is a 9-item questionnaire. Each item has four possible responses, ranging 0 (never), 1 (seldom), 2 (often) and 3 (always). The standard sum score is added up from the six questions (as defined by its author Lindsey Bergman) and then divided by 6 to make up a corresponding factor score ranging from 0-3.(worst value=0 and best value=3)|6 months|||Units on a scale||Standard Deviation|Mean
750880|NCT00554801|Secondary|Questionnaires Regarding Quality of Life||three years||||||
750881|NCT00554801|Primary|Audiological Test Results|Audiometric testing, with normal hearing specified as better (lower) than 25 decibels Hearing Level (dBHL), and a mild hearing loss between 25 to 50 dBHL.|three years|||decibels Hearing Level||Standard Deviation|Mean
750882|NCT00554840|Secondary|Side Effects|Side effects (33 items) were measured using a Side Effects Checklist (SEC). The percentage of participants endorsing each side effect were reported regardless of the severity or relation to study drug.|Weekly for 12 weeks|||Participants|||Count of Participants
750883|NCT00554840|Secondary|Brief Psychiatric Rating Scale (BPRS) - Anxiety/Depression Score|"The anxiety/depression score is calculated by adding the scores for scales #2 Anxiety and #9 Depressive Mood. Each scale ranges from 1=Not Present to 7=Very Severe. The minimum anxiety/depression score is 2 and the maximum psychosis score is 14. A higher score indicates a more severe anxiety/depression rating."|Baseline (week 0) then again during the Treatment Phase at weeks 1, 2, 4, 8, and 12.|Some BPRS anxiety/depression score data is missing due to rater error or participant absence from that study visit.||units on a scale||Standard Deviation|Mean
750884|NCT00554840|Secondary|Brief Psychiatric Rating Scale (BPRS) - Psychosis Score|"The psychosis score is calculated by adding the scores for scales #4 Conceptual Disorganization, #11 Suspiciousness, #12 Hallucinatory Behavior, and #15 Unusual Thought Content. Each scale ranges from 1=Not Present to 7=Very Severe. The minimum psychosis score is 4 and the maximum psychosis score is 28. A higher score indicates a more severe psychosis rating."|Baseline (week 0) then again during the Treatment Phase at weeks 1, 2, 4, 8, and 12.|Some BPRS total score data is missing due to rater error or participant absence from that study visit.||units on a scale||Standard Deviation|Mean
750885|NCT00554840|Secondary|Brief Psychiatric Rating Scale (BPRS) - Total Score|"The total BPRS score is calculated by adding the scores for subscales #1-#18. Each scale ranges from 1=Not Present to 7=Very Severe. Total scores range from a minimum score of 18 to a maximum score of 126. A higher total score indicates a more severe psychiatric symptom rating."|Baseline (week 0) then again during the Treatment Phase at weeks 1, 2, 4, 8, and 12.|Some BPRS total score data is missing due to rater error or participant absence from that study visit.||units on a scale||Standard Deviation|Mean
750886|NCT00554840|Primary|Level of Nicotine Dependence by Treatment Assignment|Nicotine dependence was measured using the total score from the Fagerstrom Test for Nicotine Dependence (FTND) assessment. The total score is computed by adding the scores from the five subscales. Total scores range from 1-10, with lower scores representing a smaller degree of nicotine dependence.|Weekly for 12 weeks|Some FTND data is missing due to rater error or participant absence from that study visit.||units on a scale||Standard Deviation|Mean
754766|NCT00586326|Secondary|Disease Free Survival||At 5 Years|||participants||95% Confidence Interval|Number
754767|NCT00586326|Secondary|Cause Specific Survival||At 5 Years|||participants||95% Confidence Interval|Number
750889|NCT00554853|Primary|Brachial Artery Diameter Change From Baseline in Response to Reactive Hyperemia|This measure represents the percentage change in diameter of brachial artery in response to reactive hyperemia. The data is presented intentionally and only for the results at the conclusion of the study.|8 months|Vascular function parameters were performed in patients with rheumatoid arthritis at baseline and at completion of each arm , as well as at the beginning of crossover following washout period.||% changes in diameter of artery||Inter-Quartile Range|Mean
750890|NCT00554970|Primary|Half-life (t1/2) of Budesonide on Day 8 After Administration of MAP0010 Low Dose, MAP0010 High Dose, Pulmicort Respules® 0.25mg, and Pulmicort Respules® 0.5mg|Half-life (t1/2) is the time for the drug to decrease to half of its maximum concentration. Budesonide t1/2 is reported in minutes.|Day 8 hour 12|Patients with available data at specified time points are included in the analysis population.||min||Standard Deviation|Mean
750891|NCT00554970|Primary|Half-life (t1/2) of Budesonide on Day 1 After Administration of MAP0010 Low Dose, MAP0010 High Dose, Pulmicort Respules® 0.25mg, and Pulmicort Respules® 0.5mg|Half-life (t1/2) is the time for the drug to decrease to half of its maximum concentration. Budesonide t1/2 is reported in minutes.|Day 1 hour 12|Patients with available data at specified time points are included in the analysis population.||min||Standard Deviation|Mean
750892|NCT00554970|Primary|AUC(0-inf) of Budesonide on Day 8 After Administration of MAP0010 Low Dose, MAP0010 High Dose, Pulmicort Respules® 0.25mg, and Pulmicort Respules® 0.5mg|The AUC(0-inf) is the area under the plot of plasma concentration of drug against time after drug administration. Budesonide AUC(0-inf) is reported in picograms times minutes per milliliter (pg*min/ml).|Day 8 hour 12|Patients with available data at specified time points are included in the analysis population.||pg*min/ml||Standard Deviation|Mean
750893|NCT00554970|Primary|AUC(0-inf) of Budesonide on Day 1 After Administration of MAP0010 Low Dose, MAP0010 High Dose, Pulmicort Respules® 0.25mg, and Pulmicort Respules® 0.5mg|The AUC(0-inf) is the area under the plot of plasma concentration of drug against time after drug administration. Budesonide AUC(0-inf) is reported in picograms times minutes per milliliter (pg*min/ml).|Day 1 hour 12|Patients with available data at specified time points are included in the analysis population.||pg*min/ml||Standard Deviation|Mean
750894|NCT00554970|Primary|Cmax of Budesonide on Day 8 After Administration of MAP0010 Low Dose, MAP0010 High Dose, Pulmicort Respules® 0.25mg, and Pulmicort Respules® 0.5mg|The maximum concentration (Cmax) is the highest concentration of a drug measured in the plasma. Plasma is the clear portion of the blood. The Cmax of Budesonide is reported in picograms per milliliter (pg/ml).|Day 8 hour 12|Patients with available data at specified time points are included in the analysis population.||pg/ml||Standard Deviation|Mean
750895|NCT00554970|Primary|Cmax of Budesonide on Day 1 After Administration of MAP0010 Low Dose, MAP0010 High Dose, Pulmicort Respules® 0.25mg, and Pulmicort Respules® 0.5mg|The maximum concentration (Cmax) is the highest concentration of a drug measured in the plasma. Plasma is the clear portion of the blood. The Cmax of Budesonide is reported in picograms per milliliter (pg/ml).|Day 1 hour 12|Patients with available data at specified time points are included in the analysis population.||pg/ml||Standard Deviation|Mean
750896|NCT00554996|Primary|Rate of UTI While Colonized With E. Coli 83972.|Rate of UTI during colonization with E. coli 83972.|0-266 days of colonization|Number of UTIs per 1000 patient-days during colonization with E. coli 83972.||UTIs per 1000 patient-days|||Number
750897|NCT00555009|Secondary|Change From Baseline in Waist Circumference||Baseline, Weeks 2, 4, 12, 24, and 36|Due to poor recruitment, the study was terminated early; therefore efficacy analyses were not completed.||cm||Standard Deviation|Mean
750898|NCT00555009|Secondary|Change From Baseline in Weight||Baseline, Weeks 2, 4, 12, 24, and 36|Due to poor recruitment, the study was terminated early; therefore efficacy analyses were not completed.||kg||Standard Deviation|Mean
750899|NCT00555009|Secondary|Change From Baseline in Cardiovascular Risk|The cardiovascular risk parameters (low-density lipoprotein-cholesterol, high-density lipoprotein cholesterol, total cholesterol and fasting triglycerides) was measured at all visits (Weeks 2, 4, 12, 24, and 36).|Baseline, Weeks 2, 4, 12, 24, and 36|Due to poor recruitment, the study was terminated early; therefore efficacy analyses were not completed.||scores on a scale||Standard Deviation|Mean
750900|NCT00555009|Secondary|Change From Baseline In Assessment of Growth Hormone Deficiency in Adults (AGHDA) Questionnaires at Week 36|The AGHDA is a quality of life subject-administered questionnaire that is condition-specific and comprises of 25 ‘Yes’ or ‘No’ statements covering 6 dimensions – mobility, pain, energy, sleep, emotional reactions and social isolation. The AGHDA total score change from Baseline values is calculated as the difference between the total score at Visit 6 (Week 36), and the total score at Baseline.|Baseline, Week 36|Due to poor recruitment, the study was terminated early; therefore efficacy analyses were not completed.||scores on a scale||Standard Deviation|Mean
750901|NCT00555009|Secondary|Change From Baseline in Quality of Life Using Short Form (SF)-36 Health Survey at Week 36|A subject administered scale assessing general quality of life. A subject administered score, scale, direction of scale. The SF-36 consists of 36 questions covering the following eight health domains (subscales): Physical Functioning, Bodily Pain, Role Limitations Due to Physical Problems, Role Limitations Due to Emotional Problems, General Health Perceptions, Mental Health, Social Function, Vitality.|Baseline, Week 36|Due to poor recruitment, the study was terminated early; therefore efficacy analyses were not completed.||score on a scale||Standard Deviation|Mean
750902|NCT00555009|Secondary|Change From Baseline in Neurological Outcome as Assessed by Extended Glasgow Outcome Scale (GOS-E) at Week 36|The GOS is widely used for assessing outcome after head injury and non-traumatic acute brain insults and is performed by a physician. The GOS-E uses eight points to assess disability and handicap. The GOS-E focuses on how the injury has affected functioning in major areas of life rather than on the particular deficits and symptoms caused by injury. The overall score ranges from 1-8; 1=Death and 8=Upper Good Recovery|Baseline, Week 36|Due to poor recruitment, the study was terminated early; therefore efficacy analyses were not completed.||scores on a scale||Standard Deviation|Mean
750903|NCT00555009|Secondary|Change From Baseline in Lean Body Mass and Fat Mass at Week 36|The change from Baseline values for lean body mass and fat mass is calculated as the difference between the parameter values at Visit 36, and the parameter values at Baseline.|Baseline, Week 36|Due to poor recruitment, the study was terminated early; therefore efficacy analyses were not completed.||kg||Standard Deviation|Mean
754768|NCT00586326|Secondary|Overall Survival||At 5 Years|||participants||95% Confidence Interval|Number
750904|NCT00555009|Secondary|Change From Baseline in CogState™ at Week 12 and 24.|CogState™: 7 tasks: Detection (Part A); Identification; One back working memory; Monitoring; One card learning; Prediction; Detection (Part B). Detection, Identification, Monitoring score range: 2 (worse) to 5 (best); One back working memory/one card learning score range: 0 (worse) to 1.57 (best); Prediction score range: 0 (worse) to 100 (best). Composite change score=average of cognitive change scores for each task at each postdrug assessment; total possible score: -300 to 300. Change=change from baseline (average of 2 postdose assessments). Positive composite score=improved performance.|Baseline, Week 12 and 24|Due to poor recruitment, the study was terminated early; therefore efficacy analyses were not completed.||scores on a scale||Standard Deviation|Mean
750905|NCT00555009|Primary|Change From Baseline in the Cognitive Function (CogState™) Composite Score at Week 36|CogState™: 7 tasks: Detection (Part A); Identification; One back working memory; Monitoring; One card learning; Prediction; Detection (Part B). Detection, Identification, Monitoring score range: 2 (worse) to 5 (best); One back working memory/one card learning score range: 0 (worse) to 1.57 (best); Prediction score range: 0 (worse) to 100 (best). Composite change score=average of cognitive change scores for each task at each postdrug assessment; total possible score: -300 to 300. Change=change from baseline (average of 2 postdose assessments). Positive composite score=improved performance.|Baseline, Week 36|Due to poor recruitment, the study was terminated early; therefore efficacy analyses were not completed.||scores on a scale||Standard Deviation|Mean
750906|NCT00555048|Secondary|Graft Failure|Count of participants with graft failure at day 100|Up to day 100|||Participants|||Count of Participants
750907|NCT00555048|Secondary|Extensive Chronic GVHD|Count of participants with extensive chronic GVHD at 1 year|Up to 1 year|||Participants|||Count of Participants
750908|NCT00555048|Secondary|Disease Relapse|Count of participants with disease relapse at 1 year|Up to 1 year|||Participants|||Count of Participants
750909|NCT00555048|Secondary|Overall Survival|Count of surviving participants at 1 year|Up to 1 year|||Participants|||Count of Participants
750910|NCT00555048|Secondary|Grades III-IV Acute Graft-vs-host Disease (GVHD)||Up to 100 days|||Participants|||Count of Participants
750911|NCT00555048|Secondary|Life-threatening Infection||Up to 180 days|||Participants|||Count of Participants
750912|NCT00555048|Primary|Lowest Dose of Alemtuzumab Associated With Transplant-related Mortality|Lowest dose of alemtuzumab associated with transplant-related mortality at day 180|Up to day 180|||mg total dose|||Number
750913|NCT00555061|Secondary|Number of Participants by Age With Therapeutic Response of Success|"Therapeutic response is a measure of the overall efficacy response; a response of therapeutic success was based on both clinical success and bacteriological success in a given participant."|Follow-up, Days 12 to 16|ITTB and ITTC Populations. The number analyzed is the number of participants who were clinical successes both in the ITTC Population and the ITTB Population; the number of participants who were therapeutic successes out of the total number in each respective category is shown.||participants|||Number
750914|NCT00555061|Secondary|Bacteriological Success Rate at Follow-up, by Baseline Pathogen|"Bacteriological success is defined as: (1) Bacteriological Eradication, elimination of the baseline pathogen via culture results; (2) Presumed Bacteriological Eradication, clinical success plus no culturable material from the wound; or (3) Colonization, new pathogen identified at Follow-up in a non-symptomatic participant who does not require additional antibiotic therapy. The number of pathogens eradicated out of the number isolated (shown as n in the category title) for each respective category is shown."|Follow-up, Days 12 to 16|ITTB (Intent-to-Treat Bacteriological) Population: participants who had at least one dose of study medication and a clinical diagnosis of infection plus a pathogen isolated at Baseline. Participants with more than one pathogen may be represented in the table more than once.||number of pathogens eradicated|||Number
750915|NCT00555061|Secondary|Number of Participants With Clinical Success at Follow-up, by Type of Skin Infection and by Age|SID = Secondarily Infected Dermatoses; SITL = Secondarily Infected Traumatic Lesions. Clinical Success is the number of participants with resolution of signs/symptoms of infection or improvement such that no additional antibiotic therapy was needed.|Follow-up, Days 12 to 16|Intent-to-Treat Clinical (ITTC) Population: all participants who received at least one dose of study medication; the number of participants who were clinical successes out of the total number in each respective category is shown||participants|||Number
750916|NCT00555061|Primary|Number of Participants With Measurable Plasma Concentrations, by Age Group|Pharmacokinetic (PK) samples were collected randomly in the window of 4 to 8 hours post-dose (except one at 3 hours and one at 11 hours post-dose) after the first daily dose of treatment on Day 3 or Day 4. The lower limit of quantification (LLQ) for retapamulin was 0.5 ng/mL.|Days 3 to 4; 4 to 8 hours post-dose of the first dose of the day|Pharmacokinetic (PK) Population: all participants who received at least one dose of study medication and who had PK samples taken. Seven participants did not have PK samples collected.||participants|||Number
750917|NCT00555152|Primary|Incidence of Adverse Events Graded According to the National Cancer Institute (NCI) Common Terminology Criteria (CTCAE) Version 3.0|Toxicity profile summarized reflects incidence by number of participants affected with adverse events by Maximum Grade 1 to 3, additional adverse event according to the NCI CTCAE version 3.0 reported in Adverse Event section results.|From baseline to 4-5 weeks after surgery|||participants|||Number
750918|NCT00555152|Secondary|Biomarker Analysis of Proliferation Markers|Correlation analysis and linear models will be used to evaluate associations among marker values at baseline and among changes in marker values and treatment. All statistical tests will be two-sided.|2-6 weeks from baseline to surgery, Up to 6 weeks|No outcome data available due to laboratory issues affecting the analysis of biomarkers results.|||||
750919|NCT00555152|Secondary|Incidence of Ductal Carcinoma in Situ Remaining at Resection|Number of participants with DCIS incidence on surgical excision. Differences in histologic response (disappearance of DCIS) will be evaluated using Fisher’s exact test. Correlation analysis and linear models will be used to evaluate associations among marker values at baseline and among changes in marker values and treatment. All statistical tests will be two-sided.|2-6 weeks from baseline to surgery, up to 6 weeks|DCIS was present at the time of surgery in all patients.||participants|||Number
751021|NCT00555620|Secondary|Tmax for 5'DFUR||Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; number of participants analyzed (N): participants with evaluable data||hr||Full Range|Median
750920|NCT00555152|Primary|Proliferation (Ki67 IHC) in Ductal Breast Carcinoma In Situ (DCIS)|Reduction in percent of Ki67 positive cells at surgery compared to baseline as a function of treatment. Analysis of the primary treatment comparison will be based on a two sample t-test comparing change in log-transformed Ki67% for placebo and treated subjects. P-values of 0.05 will be considered significant. Proliferation will be assessed by immunohistochemical (IHC) staining for Ki67, and the change in percentage of Ki67 positive cells will be compared in lapatinib-treated samples versus placebo.|2-6 weeks from baseline to surgery, up to 6 weeks|No outcome data available due to laboratory issues affecting the analysis of biomarkers results.|||||
750921|NCT00555217|Secondary|A Renal Composite Endpoint, Defined as; Reduction in Estimated GFR of >50% (for Individuals With Baseline GFR <60) or Reduction in GFR of >30 (for Individuals With Baseline GFR >= GFR 60) or ESRD.|Time to the first event of reduction in estimated GFR of >50% (for individuals with baseline GFR <60) or reduction in GFR of >30 (for individuals with baseline GFR >= GFR 60) or ESRD.|From enrollment to time of first event, up to 4.5 years|||participants|||Number
750922|NCT00555217|Primary|A Composite Endpoint of Reduction in Estimated GFR of 30ml/Min/1.73m*m in Individuals w/a Baseline Estimated GFR >= 60 ml/Min/1.73m*m, Reduction in Estimated GFR >50% in Individuals w/ Baseline Estimated GFR <60ml/Min/1.73m*m; ESRD or Death|Time to the first event of reduction in estimated GFR of 30ml/min/1.73m*m in individuals w/a baseline estimated GFR >= 60 ml/min/1.73m*m, reduction in estimated GFR >50% in individuals w/ baseline estimated GFR <60ml/min/1.73m*m; ESRD or death.|From enrollemnt to time of first primary event, up to 4.5 years|||participants|||Number
750984|NCT00555360|Primary|Heart Failure-specific Quality of Life|Measured by the Minnesota Living with Heart Failure Questionnaire (MLHFQ). Lower scores indicate better functioning. MLHFQ contains 21 items with answer choices ranging from 0 to 5. Overall scores on the instrument range from 0 to 105.|twelve-month followup|||units on a scale||Standard Deviation|Mean
750985|NCT00555425|Secondary|Health Status|Measured by the SF-36 overall transformed measure. In the SF-36 all items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.|18 weeks|Results are provided on those individuals who completed this assessment||units on a scale||Standard Deviation|Mean
755233|NCT00593372|Primary|Number of Successful Memory Tasks Completed Over Study Period.|"Successful memory tasks are those memory tasks (such as where do I keep my keys) that participants are able to consistently respond to."|8 weeks|||memory tasks|||Number
750982|NCT00555360|Secondary|Adherent to Heart Failure Medication|Percent of patients with perfect Heart Failure medication adherence over the prior month as measured by the four Heart Failure Self-Care Behavior items focused on adherence.|twelve-month follow-up|||percentage of participants/perfect adher|||Number
750983|NCT00555360|Secondary|Revised Heart Failure Self-Care Behavior Scale (HFSCB)|Higher scores indicate better Heart Failure self-care. The HFSCB contains 29 items with answer choices ranging from 0 to 5. The total score ranges from 0 to145.|twelve-month follow-up|||units on a scale||Standard Deviation|Mean
750987|NCT00555425|Secondary|Changes in HIV Risk|"As measured by the AIDS Risk Inventory. The AIDS Risk Inventory (ARI) is a 166 item structured interview that assesses the number and frequency of drug-related and sexual risk behaviors in the preceding 3 months. Calculation of the ARI total score is based on the frequency of occurrence of a given behavior and on the recency of this behavior, with recency being weighted more than a life-time occurrence of the same behavior. Higher values are associated with greater risk of HIV transmission (worse).
There are 10 subscales comprised of between 8 and 24 items. Subscales scores are based on the sum of the individual items and the overall ARI total score is the sum of the subscales.
Scores can range from 0 to 350, although among opioid dependent patients most values are below 100 with means between 50 and 60 depending on characteristics of the patients and treatment status."|Baseline and 18 weeks|||units on a scale||Standard Deviation|Mean
750988|NCT00555425|Secondary|Reduction in Cocaine Use|As measured by the percent of provided urines positive for cocaine|18 weeks|||percent of cocaine positive urines||Standard Deviation|Mean
750989|NCT00555425|Secondary|Retention in Treatment|Mean number of days from randomization to last clinical contact|18 weeks|||number of days||95% Confidence Interval|Mean
750990|NCT00555425|Secondary|Proportion of Patients Protectively Transferred|>= 2 consecutive weeks of daily illicit opioid use and opioid positive urine samples after completion of the first 6 weeks of the study|18 weeks|||participants|||Number
750991|NCT00555425|Primary|Illicit Opioid Use|Urinalysis based on scheduled weekly urine screenings during treatment period|18 weeks|||percent of opioid negative urine samples||95% Confidence Interval|Mean
750992|NCT00555438|Secondary|Death at 1 Month ± 5 Days|Evaluate the total number of death at 1 month ± 5 days|1 month ± 5 days|||participants|||Number
750993|NCT00555438|Secondary|Number of Patients With Symptomatic Deep Vein Thrombosis and Pumonary Embolism at 1 Month ± 5 Days|Evaluate the number of patients affected by symptomatic Deep Vein Thrombosis (any symptomatic distal and/or proximal deep-vein thrombosis) and Pumonary Embolism (symptomatic pulmonary embolism confirmed by objective tests) at 1 month ± 5 days.|at 1 month ± 5|||participants|||Number
750994|NCT00555438|Secondary|Number of Patients With Symptomatic Deep Vein Thrombosis and Pumonary Embolism Between Day 1 and Day 10|Evaluate the number of patients affected by symptomatic Deep Vein Thrombosis (any symptomatic distal and/or proximal deep-vein thrombosis) and Pumonary Embolism (symptomatic pulmonary embolism confirmed by objective tests) between Day 1 and Day 10.|10 days|||participants|||Number
750995|NCT00555438|Secondary|Number of Patients With Major Bleedings at 1 Month ± 5 Days.|evaluate the number of patients affected by major bleedings defined as fatal, involved a critical organ, treatment cessation, occurred at the surgical site and necessitated any medical intervention, or if it was overt and necessitated transfusion of >2 units of packed red blood cells or was associated with a fall in hemoglobin >20 g/L at 1 month ± 5 days.|45 day|||participants|||Number
750996|NCT00555438|Primary|Number of Patients With Major Bleedings Between Day 1 and Day 10.|evaluate between Day 1 and Day 10, the number of patients under study treatment who has affected by major bleedings defined as fatal, involved a critical organ, treatment cessation, occurred at the surgical site and necessitated any medical intervention, or if it was overt and necessitated transfusion of >2 units of packed red blood cells or was associated with a fall in hemoglobin >20 g/L.|10 day|||participants|||Number
750997|NCT00555464|Secondary|Toxicity to Medications|"Adverse events were closely monitored and recorded at weekly visits during treatment period and for two years after treatment ceased. Laboratory values were taken every other week during the treatment period.
Please see Adverse Events module for more details."|Initial visit, 2, 4, 6, 10 and 12 weeks of therapy|||participants|||Number
750998|NCT00555464|Primary|Response of Hemangioma (IH) to Treatment|"Response of IH not confined to the dermis will be coded using the following criteria: Progressive disease: >40% increase in volume by MRI, Partial response: >65% reduction in volume by MRI, Complete response: no visual or radiographic evidence of disease, Stable disease: none of the above or <40% increase or <65% decrease in volume by MRI.
Response of superficial IH will be coded using the following criteria (based on RECIST): Progressive disease: >30% increase in IH size, Partial response: >30% reduction in size, Complete response: no evidence of disease, Stable disease: none of the above.
Our first 3 patients showed limits to using MRI volume to measure IH size/response to therapy. Unlike other solid tumors, the superficial distribution of some IH made getting volume by MRI difficult, resulting in smaller tumor estimation compared to clinical assessment. Based on these observations, we amended the protocol to report response based on RECIST criteria instead of change in IH volume."|6 weeks|Per protocol, all participants were analyzed, no matter the treatment arm or treatment success.||participants|||Number
750999|NCT00555477|Primary|The Number of Women Who Recover Ovarian Function Within 12 Months of Al Monotherapy|In part 1 ovarian function recurrence is defined as one estradiol value >20 pg/ml or two consecutive values >10 pg/ml. In part 2 ovarian function recurrence is defined as a >75% increase in estradiol levels over prior if prior value was 15-30 pg/ml, or one estradiol value >30 pg/ml, or three consecutive values >20 pg/ml.|12 months|||participants|||Number
751000|NCT00555568|Primary|Overall Mental Health (BASIS-24 Summary Score)|BASIS-24 refers to the 24-item Behavior and Symptom Identification Scale. Responses range from 0-4; scores range from 0-4; higher values indicate greater symptom severity.|3 months|||units on a scale||Standard Deviation|Mean
751001|NCT00555568|Primary|VR-12 MCS|VR-12 MCS refers to the Mental Health Component of the SF-12. The rating scale varies depending on the item. Scores range from 0-100; higher values indicate better mental health;|3 months|||units on a scale||Standard Deviation|Mean
751002|NCT00555568|Primary|Social Support|Social Support was assessed by the Medical Outcomes Study Social Support Survey. Response options range from 1-5 and scores range from 19-95. Higher scores indicate greater social support|3 months|||units on a scale||Standard Deviation|Mean
751003|NCT00555568|Primary|Empowerment|Empowerment is measured by the “Making Decisions” instrument. Response options range from 1-4 and scores can range from 28-112. Higher scores indicate more empowerment.|3 months|||units on a scale||Standard Deviation|Mean
751004|NCT00555568|Primary|Patient Activation|"Patient activation refers to patient knowledge skill and confidence for self-management.
Full name of the scale is Patient Activation Measure (PAM). Scale response options range from 1-4 and scores can range from 13-52. Higher values indicate greater activation. No subscales are used."|3 months|||units on a scale||Standard Deviation|Mean
755234|NCT00593450|Secondary|Change in Diastolic Blood Pressure From Baseline||Baseline and 1 Year|||mm Hg||Standard Deviation|Mean
751006|NCT00555620|Secondary|Duration of Response (DR)|DR defined as time from start of first documented objective tumor response (CR or PR) to first documented objective tumor progression or death due to any cause, whichever occurs first.|Baseline up to Month 15|Efficacy analysis set population; No participants in the SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 reporting group analyzed; all had stable disease during specified time frame||months||Full Range|Median
751007|NCT00555620|Secondary|Percentage of Participants With Objective Response|Percentage of participants with an objective response-based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as the disappearance of all target lesions. PR defined as ≥30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Baseline, Day 21 of every even-numbered cycle up to 15 months|Efficacy analysis set population: all participants enrolled in the study who received at least 1 dose of study medication (SU011248).||percentage of participants||95% Confidence Interval|Number
751008|NCT00555620|Secondary|AUClast for 5-FU|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) and Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours)|PK analysis set population; Number of participants analyzed (N): participants with evaluable data; n: participants with evaluable data for specified category||ng*hr/mL||Standard Deviation|Mean
751009|NCT00555620|Secondary|AUClast for 5'DFUR|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) and Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours)|PK analysis set population; Number of participants analyzed (N): participants with evaluable data; n: participants with evaluable data for specified category||ng*hr/mL||Standard Deviation|Mean
751010|NCT00555620|Secondary|AUClast for 5'DFCR|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) and Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours)|PK analysis set population; Number of participants analyzed (N): participants with evaluable data; n: participants with evaluable data for specified category||ng*hr/mL||Standard Deviation|Mean
751011|NCT00555620|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for CAP|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) and Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours)|PK analysis set population; Number of participants analyzed (N): participants with evaluable data; n: participants with evaluable data for specified category||ng*hr/mL||Standard Deviation|Mean
751012|NCT00555620|Secondary|Area Under the Curve From Time Zero to 12 Hours [AUC (12)] for CAP, 5'DFCR, 5'DFUR, and 5-FU|AUC (12) = Area under the plasma concentration versus time curve from time zero (predose) to the extrapolated time 12 hours postdose. It is obtained from AUC (0 - last) plus AUC (last - 12)|Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; Number of participants analyzed (N): participants with evaluable data; n: participants with evaluable data for specified category||ng*hr/mL||Standard Deviation|Mean
751013|NCT00555620|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]: CAP, 5'DFCR, 5'DFUR, and 5-FU|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; Number of participants analyzed (N): participants with evaluable data; n: participants with evaluable data for specified category||ng*hr/mL||Standard Deviation|Mean
751014|NCT00555620|Secondary|Area Under the Curve From Time 0 to 24 Hours Postdose (AUC [0-24]) for SU, SU012662, and Total Drug (SU + SU012662)|Area under the plasma concentration-time curve from time 0 to 24 hours postdose (0-24), also considered the AUC between doses at steady state.|Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)|PK analysis set population; Number of participants analyzed (N): participants with evaluable data||nanogram hours per milliliter (ng*hr/mL)||Standard Deviation|Mean
751015|NCT00555620|Secondary|t1/2 for 5-FU|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; Number of participants analyzed (N): participants with evaluable data||hr||Standard Deviation|Mean
751016|NCT00555620|Secondary|t1/2 for 5'DFUR|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; Number of participants analyzed (N): participants with evaluable data||hr||Standard Deviation|Mean
751017|NCT00555620|Secondary|t1/2 for 5'DFCR|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; Number of participants analyzed (N): participants with evaluable data||hr||Standard Deviation|Mean
751018|NCT00555620|Secondary|t1/2 for CAP|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; Number of participants analyzed (N): participants with evaluable data||hr||Standard Deviation|Mean
751019|NCT00555620|Secondary|Terminal Elimination Half-Life (t1/2) for SU, SU012662, and Total Drug (SU + SU012662)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)|Not analyzed; t1/2 could not be accurately estimated due to the long t1/2 of SU and its active metabolite and due to short PK collection period of only 24 hrs.|||||
751020|NCT00555620|Secondary|Tmax for 5-FU||Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; number of participants analyzed (N): participants with evaluable data||hr||Full Range|Median
755235|NCT00593450|Secondary|Change in Systolic Blood Pressure From Baseline||Baseline and 1 Year|||mm Hg||Standard Deviation|Mean
751024|NCT00555620|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) for SU, SU012662, and Total Drug (SU + SU012662)||Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)|PK analysis set population; number of participants analyzed (N): participants with evaluable data||hour (hr)||Full Range|Median
751025|NCT00555620|Secondary|Cmin of 5-FU||Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; number of participants analyzed (N): participants with evaluable data||ng/mL||Standard Deviation|Mean
751026|NCT00555620|Secondary|Cmin of 5'DFUR||Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; number of participants analyzed (N): participants with evaluable data||ng/mL||Standard Deviation|Mean
751027|NCT00555620|Secondary|Cmin of 5'DFCR||Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; number of participants analyzed (N): participants with evaluable data||ng/mL||Standard Deviation|Mean
751028|NCT00555620|Secondary|Cmin of CAP||Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; number of participants analyzed (N): participants with evaluable data||ng/mL||Standard Deviation|Mean
751029|NCT00555620|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) of SU, SU012662, and Total Drug (SU + SU012662)||Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)|Pharmacokinetic (PK) analysis set population: all participants who received sunitinib and had sufficient plasma concentration data to facilitate calculation of the PK parameters; number of participants analyzed (N): participants with evaluable data||ng/mL||Standard Deviation|Mean
751030|NCT00555620|Secondary|Cmax of 5-fluorouracil (Metabolite of CAP, 5-FU)||Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; number of participants analyzed (N): participants with evaluable data||ng/mL||Standard Deviation|Mean
751031|NCT00555620|Secondary|Cmax of 5’-Deoxy-5-fluorouridine (Metabolite of CAP, 5'DFUR)||Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; number of participants analyzed (N): participants with evaluable data||ng/mL||Standard Deviation|Mean
751032|NCT00555620|Secondary|Cmax of 5'-Deoxy-5-fluorocytidine (Metabolite of CAP, 5'DFCR)||Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; number of participants analyzed (N): participants with evaluable data||ng/mL||Standard Deviation|Mean
751033|NCT00555620|Secondary|Cmax of CAP||Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; number of participants analyzed (N): participants with evaluable data||ng/mL||Standard Deviation|Mean
751034|NCT00555620|Secondary|Maximum Observed Plasma Concentration (Cmax) of SU, SU012662 (Metabolite of SU), and Total Drug (SU + SU012662)||Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)|Pharmacokinetic (PK) analysis set population: all participants who received sunitinib and had sufficient plasma concentration data to facilitate calculation of the PK parameters; number of participants analyzed (N): participants with evaluable data||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
751035|NCT00555620|Primary|Number of Participants With First-cycle Dose Limiting Toxicities (DLTs)|Any DLT event in Cycle 1: Grade (GR) 3/4 nausea, vomiting, or diarrhea despite anti-emetics, anti-diarrheals; GR 3 nonhematological toxicity for greater than or equal to (≥)7 days (except alopecia, skin or hair discoloration, hyperamylasemia, or hyperlipasemia without other clinical evidence of pancreatitis and asymptomatic hyperuricemia); GR 4 nonhematological toxicity; GR 4 neutropenia ≥7 days or thrombocytopenia; GR ≥3 febrile neutropenia or neutropenic infection; GR 3 thrombocytopenia ≥7 days; any treatment-related toxicity having >3 consecutive CAP or SU missed doses per cycle; delayed toxicity recovery >14 days.|Baseline up to Day 21|DLT subpopulation analysis set population: all participants who received at least 1 dose of study drug and did not permanently discontinue during the first cycle of treatment for reasons other than a DLT or miss more than 3 consecutive doses of sunitinib or capecitabine for reasons other than for drug related toxicities within the first cycle.||participants|||Number
751036|NCT00555672|Secondary|Progression-Free Survival (PFS)|Median time (50%) from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first. PFS calculated as (Months) equals (first event date minus first dose date plus 1) divided by 30.|Baseline up to Month 15|Efficacy||Months||95% Confidence Interval|Median
751037|NCT00555672|Secondary|Duration of Response (DR)|Time from the first objective documentation of tumor response (confirmed or partial response) to first documented objective tumor progression or death due to any cause, whichever occurrs first. DR calculated as (Months) equals (the end date for DR minus first subsequent confirmed CR or PR plus 1) divided by 30.|Baseline up to Month 15|Efficacy; N=number of participants with objective response.||Months||Standard Deviation|Mean
751038|NCT00555672|Secondary|Number of Participants With Objective Response|Number of participants with an objective response-based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as the disappearance of all target lesions. PR defined as greater than or equal to (≥) 30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Baseline, Day 21 of every even-numbered cycle up to 15 Months|Efficacy: all participants enrolled in the study who received at least 1 dose of study medication. N=number of participants with measurable disease at baseline.||Participants|||Number
751039|NCT00555672|Secondary|Area Under the Curve From Time 2 to 6 Hours Postdose [AUC (2-6)] of 5-FU|Area under the plasma concentration versus time curve from time 2 to 6 hours postdose (2-6).|Day 1 of Cycle 1 (2, 4, and 6 hours post infusion)|PK; N=number of participants contributing to the summary statistics. Css calculated for at least 6 individual participants treated at the MTD (25 mg Sunitinib).||ng*h/mL||Standard Deviation|Mean
751216|NCT00549900|Primary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed include arthralgia, fatigue, fever, gastrointestinal symptoms, headache, myalgia, rash, and urticaria.|During the 7-day (Day 0-6) period following each vaccination|||Subjects|||Number
751040|NCT00555672|Secondary|Clearance (CLss) of 5-FU|Steady state total body clearance equals infusion rate (zero order) divided by steady state plasma concentration of 5-FU (R0/Css).|Day 1 of Cycle 1 (2, 4, and 6 hours post infusion)|PK; N=the number of participants contributing to the summary statistics. CLss calculated for at least 6 individual participants treated at the MTD (25 mg Sunitinib).||Liters per hour||Standard Deviation|Mean
751041|NCT00555672|Secondary|Infusion Rate (Zero Order) (R0) of 5-FU|Infusion rate of 5-FU equals total dose divided by infusion time.|Day 1 of Cycle 1 (2, 4, and 6 hours post infusion)|PK; N= number of participants contributing to the summary statistics. R0 calculated for at least 6 individual participants treated at the MTD (25 mg Sunitinib).||mg/hr||Standard Deviation|Mean
751042|NCT00555672|Secondary|Steady State Concentration (Css) of 5-Fluorouracil (5-FU)|Steady state plasma concentration of 5-FU equals AUC(2-6) divided by 4, where AUC(2-6) is the area under the plasma concentration versus time curve from time 2 to 6 hours postdose (2-6).|Day 1 of Cycle 1 (2, 4, and 6 hours post infusion)|PK; N=number of participants contributing to the summary statistics. Css calculated for at least 6 individual participants treated at the MTD (25 mg Sunitinib).||ng/mL||Standard Deviation|Mean
751043|NCT00555672|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)|Tmax is the time to first occurrence of maximum observed plasma concentration (Cmax).|Day 1 of Cycle 1 (2, 4, 6, 8, 10, and 24 hours post dose)|PK; N=the number of participants contributing to the summary statistics. Tmax of Sunitinib, SU012662, and Total Drug (Sunitinib + SU012662) calculated for at least 6 individual participants treated at the MTD (25 mg Sunitinib).||hours||Full Range|Median
751044|NCT00555672|Secondary|Area Under the Curve From Time 0 to 24 Hours Postdose [AUC (0-24)]|Area under the plasma concentration versus time curve from time 0 (pre-dose) to 24 hours postdose (0-24).|Day 1 of Cycle 1 (2, 4, 6, 8, 10, and 24 hours postdose)|PK; N=the number of participants contributing to the summary statistics. AUC(0-24) of Sunitinib, SU012662, and Total Drug (Sunitinib + SU012662) calculated for at least 6 individual participants treated at the maximum tolerated dose (MTD; 25 mg Sunitinib).||ng*h/mL||Standard Deviation|Mean
751045|NCT00555672|Secondary|Maximum Observed Plasma Concentration (Cmax)||Day 1 of Cycle 1 (2, 4, 6, 8, 10, and 24 hours post dose)|Pharmacokinetic (PK): participants who received Sunitinib and had sufficient plasma concentration data for calculation of PK parameters; N=number of participants contributing to summary statistics. Cmax of Sunitinib, SU012662, and Total Drug (Sunitinib + SU012662) calculated for at least 6 individual participants treated at maximum tolerated dose.||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
751046|NCT00555672|Primary|Number of Participants With First-cycle Dose Limiting Toxicities (DLTs)|The incidence of DLTs assessed during the first cycle (21 days).|Cycle 1 (Baseline to Day 21)|Safety: enrolled participants who received at least 1 dose of study drug.||Participants|||Number
751047|NCT00555750|Secondary|Change in Total Sleep Time Measured by PSG|Change (baseline minus post-treatment) in total sleep time measured by polysomnography after two months treatment with 3mg eszopiclone or placebo|baseline and 2 months post-treatment|||minutes||Standard Deviation|Mean
751048|NCT00555750|Secondary|Change in Total Sleep Time as Reported in Sleep Diaries|Total sleep time reported on sleep diaries prior to treatment with 3mg eszopiclone or placebo. Change defined as baseline minus post-treatment).|baseline and 2 months post-treatment|||hours||Standard Deviation|Mean
751049|NCT00555750|Secondary|Change in Mean Lapses of Attention|At visits before and after two months treatment with 3mg eszopiclone or placebo, subjects completed a short test battery every three hours during wake periods. The battery included the Psychomotor Vigilance Task (PVT). The PVT involved a 10-minute visual reaction time (RT) performance test in which the subject was instructed to maintain the fastest possible RT to a simple visual stimulus. Lapses of attention refer to the number of times the subject failed to respond to the signal within 500ms. Mean lapses per test across 6 tests given a 4 hour intervals during normal waking hours (and not during the IVGTT) during the 30-hr were compared for the post-treatment visit as the absolute deviation from the baseline mean lapses/test.|baseline and 2 months post-treatment|||lapses of attention||Standard Error|Mean
751050|NCT00555750|Secondary|Change in Subjective Sleepiness as Measured on the Karolinska Sleepiness Scale (KSS)|"At visits before and after two months treatment with 3mg eszopiclone or placebo, subjects completed a short test battery including the Karolinska Sleepiness Scale (KSS) every three hours during wake periods. KSS is a single-item scale of sleepiness on a scale from 1 (very alert) to 9 (very sleepy, fighting sleep, an effort to keep awake). Subjective sleepiness was defined as mean deviation from baseline KSS."|baseline and 2 months post-treatment|||units on a scale||Standard Error|Mean
751051|NCT00555750|Secondary|Post-treatment Ghrelin Levels|Ghrelin levels following two months treatment with 3mg eszopiclone or placebo, measured after an overnight fast|2 months post-treatment|||ng/mL||Standard Deviation|Mean
751052|NCT00555750|Secondary|Pre-treatment Ghrelin Levels|Ghrelin levels prior to two months treatment with 3mg eszopiclone or placebo, measured after an overnight fast|baseline|||ng/mL||Standard Deviation|Mean
751053|NCT00555750|Secondary|Post-treatment Leptin Levels|Leptin levels following two months treatment with 3mg eszopiclone or placebo, measured after an overnight fast|two months post-treatment|||ng/mL||Standard Deviation|Mean
751054|NCT00555750|Secondary|Pre-Treatment Leptin Levels|Leptin Levels prior to two months treatment with eszopiclone or placebo, measure after an overnight fast|baseline|||ng/mL||Standard Deviation|Mean
751055|NCT00555750|Secondary|Change in HbA1c Levels|Difference in HbA1c levels following two months treatment with eszopiclone versus placebo|baseline and 2 months post-treatment|||percentage of glycosylation||Standard Error|Mean
751056|NCT00555750|Secondary|Change in Glucose Effectiveness (SG)|"Glucose effectiveness was defined as the ability of glucose itself to enhance its own disappearance independent of an increment in insulin. [R. Bergman, Horm Res 2005;64(suppl 3):8-15].
SG calculated using Bergman's Minimal model analyses (Minmod Millennium 2000; R. Bergman, University of South- ern California, Los Angeles, CA)"|baseline and 2 months post-treatment|||min^-1||Standard Deviation|Mean
751057|NCT00555750|Secondary|Change in Insulin Sensitivity (SI)|"Insulin sensitivity index (SI) was defined in quantitative terms as the effect of insulin to catalyse the disappearance of glucose from plasma. [R. Bergman, Horm Res 2005;64(suppl 3):8-15].
SI calculated using Bergman's Minimal model analyses (Minmod Millennium 2000; R. Bergman, University of South- ern California, Los Angeles, CA)"|baseline and 2 months post-treatment|||mU/l)^-1*min^-1||Standard Deviation|Mean
751058|NCT00555750|Secondary|Acute Insulin Response to Glucose (AIRg)|Change over two months in 1st phase Insulin secretion|baseline and 2 months post-treatment|||mU*l^-1*min||Standard Deviation|Mean
751059|NCT00555750|Primary|Change in Glucose Tolerance (Kg) in Response to Insulin-modified Intravenous Glucose Tolerance Test|Difference in glucose tolerance (Kg) in response to insulin-modified intravenous glucose tolerance test. Glucose tolerance was calculated as the slope of the natural log of declining glucose values from minute 5 to minute 19 post-infusion. By convention, this negative slope is multiplied by -1, in other words, expressed as a rate of disposal.|baseline and 2 months post-treatment|||%/min, slope of natural log glucose||Standard Deviation|Mean
751060|NCT00555880|Secondary|Number of Participants With Shifts in Reference to Normal Range For Urinalysis at Discharge|For urinalysis, samples were taken at screening, study admission (if greater than 14 days since screening) and discharge/early termination): glucose, blood, protein, pH, specific gravity, leukocyte esterase, and microscopic examination. A shift in reference to normal was higher at discharge.|Baseline to discharge|The Safety population, defined as all subjects who received at least one dose of investigational product.||participants|||Number
751061|NCT00555880|Primary|Time to Onset of Near-syncopal Symptoms During Tilt Table Testing-Re-analysis With The Koch Procedure|The tilt table test is a 10-minute assessment performed using a manual or automated tilt table in a specialized laboratory. Subjects were moved onto the horizontal table and secured to the table with straps to prevent injury. After an equilibration period of at least 10 minutes with the subject at rest, the test began and the head of the tilt table was elevated to a 70-degree angle over a period of up to 30 seconds. The head-up tilt table test in this study was conducted 1 hour after administration of the study medication. The endpoint was a confirmed report of a near-syncopal symptom(s) (of sufficient severity that caused the patient to ask that the tilt table be returned to the horizontal position). Symptoms of near syncope were defined as dizziness, lightheadedness, feeling faint, or feeling like the subject might black out. The Koch procedure is a 3-step process to analyze results while utilizing the available information on magnitude of differences.|1 hour post-dose|The Full Analysis Set, defined as subjects who were randomized, received at least one dose of study drug, and had at least one measurement of time to syncope during tilt table testing.||seconds||Standard Deviation|Mean
751062|NCT00555880|Secondary|Number of Participants With Shifts in Reference to Normal Range For Clinical Chemistry at Discharge|For biochemistry, blood samples (10.0mL) were taken at screening, admission (if greater than 14 days since screening) and discharge/early termination. The following parameters were assessed: sodium, potassium, calcium, blood urea nitrogen (BUN)/Urea, creatinine, albumin, total protein and albumin/globulin (A/G) ratio, globulin, aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase (ALP), gamma glutamyl transferase (GGT), total bilirubin, glucose, chloride, and creatine kinase. A shift in reference to normal was either lower or higher at discharge.|Baseline to discharge|The Safety population, defined as all subjects who received at least one dose of investigational product.||participants|||Number
751063|NCT00555880|Secondary|Number of Participants With Shifts in Reference to Normal Range For Hematology Analytes at Discharge|For hematology, blood samples (5.0mL) were taken at screening, study admission (if greater than 14 days since screening) and discharge/early termination. The following parameters were assessed: hemoglobin, hematocrit, red blood cells (RBC), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), white blood cell count – total and differential (WBC), and platelet count. A shift in reference to normal was either lower or higher at discharge.|Baseline to discharge|The Safety population, defined as all subjects who received at least one dose of investigational product.||participants|||Number
751064|NCT00555880|Secondary|Heart Rate at 1 Minute and 10 Minutes Into The Tilt Table Test Conducted 1 and 3 Hours Post-dose at Treatment Visit 2|Heart rate was recorded just before tilt table testing, at each minute during tilt table testing, and immediately after. Timed readings were stopped once a subject experienced near-syncopal symptoms, except for subjects for whom the table was returned to horizontal before 1 minute; for these subjects, a reading was made at 1 minute and was included in analyses. The tilt table test is a 10-minute assessment performed using a manual or automated tilt table in a specialized laboratory. Subjects were moved onto the horizontal table and secured to the table with straps to prevent injury. After an equilibration period of at least 10 minutes with the subject at rest, the test began and the head of the tilt table was elevated to a 70-degree angle over a period of up to 30 seconds. Symptoms of near syncope were defined as dizziness, lightheadedness, feeling faint, or feeling like the subject might black out.|1 and 3 hours post-dose|The Full Analysis Set, defined as subjects who were randomized, received at least one dose of study drug, and had at least one measurement of time to syncope during tilt table testing.||beats per minute||Standard Deviation|Mean
751065|NCT00555880|Secondary|Diastolic Blood Pressure at 1 Minute and 10 Minutes Into The Tilt Table Test Conducted 1 and 3 Hours Post-dose at Treatment Visit 2|Blood pressure was recorded just before tilt table testing, at each minute during tilt table testing, and immediately after. Timed readings were stopped once a subject experienced near-syncopal symptoms, except for subjects for whom the table was returned to horizontal before 1 minute; for these subjects, a reading was made at 1 minute and was included in analyses. The tilt table test is a 10-minute assessment performed using a manual or automated tilt table in a specialized laboratory. Subjects were moved onto the horizontal table and secured to the table with straps to prevent injury. After an equilibration period of at least 10 minutes with the subject at rest, the test began and the head of the tilt table was elevated to a 70-degree angle over a period of up to 30 seconds. Symptoms of near syncope were defined as dizziness, lightheadedness, feeling faint, or feeling like the subject might black out.|1 and 3 hours post-dose|The Full Analysis Set, defined as subjects who were randomized, received at least one dose of study drug, and had at least one measurement of time to syncope during tilt table testing.||mmHg||Standard Deviation|Mean
751217|NCT00549900|Primary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling.|During the 7-day (Day 0-6) period following each vaccination|||Subjects|||Number
755236|NCT00593450|Secondary|Area of Lesion Change From Baseline||Baseline and 1 Year|||mm^2||Standard Deviation|Mean
751066|NCT00555880|Primary|Time to Onset of Near-syncopal Symptoms During Tilt Table Testing Analysis #2|The tilt table test is a 10-minute assessment performed using a manual or automated tilt table in a specialized laboratory. Subjects were moved onto the horizontal table and secured to the table with straps to prevent injury. After an equilibration period of at least 10 minutes with the subject at rest, the test began and the head of the tilt table was elevated to a 70-degree angle over a period of up to 30 seconds. The head-up tilt table test in this study was conducted 1 hour after administration of the study medication. The endpoint was a confirmed report of a near- syncopal symptom(s) (of sufficient severity that caused the patient to ask that the tilt table be returned to the horizontal position). Symptoms of near syncope were defined as dizziness, lightheadedness, feeling faint, or feeling like the subject might black out. In this outcome measure, the data analyzed are the same as for Outcome Measure 1 but the summary data are presented as least squares mean (standard error).|1 hour post-dose|The FAS, defined as subjects who were randomized, received at least one dose of study drug, and had at least one measurement of time to syncope during tilt table testing.||seconds||Standard Error|Least Squares Mean
751067|NCT00555880|Secondary|Systolic Blood Pressure at 1 Minute and 10 Minutes Into The Tilt Table Test Conducted 1 and 3 Hours Post-dose at Treatment Visit 2|Blood pressure was recorded just before tilt table testing, at each minute during tilt table testing, and immediately after. Timed readings were stopped once a subject experienced near-syncopal symptoms, except for subjects for whom the table was returned to horizontal before 1 minute; for these subjects, a reading was made at 1 minute and was included in analyses. The tilt table test is a 10-minute assessment performed using a manual or automated tilt table in a specialized laboratory. Subjects were moved onto the horizontal table and secured to the table with straps to prevent injury. After an equilibration period of at least 10 minutes with the subject at rest, the test began and the head of the tilt table was elevated to a 70-degree angle over a period of up to 30 seconds. Symptoms of near syncope were defined as dizziness, lightheadedness, feeling faint, or feeling like the subject might black out.|1 and 3 hours post-dose|The Full Analysis Set, defined as subjects who were randomized, received at least one dose of study drug, and had at least one measurement of time to syncope during tilt table testing.||mmHg||Standard Deviation|Mean
751068|NCT00555880|Secondary|Final Blood Pressure During Tilt Table Testing|Blood pressure was recorded just before tilt table testing and immediately after. Timed readings were stopped once a subject experienced near-syncopal symptoms, except for subjects for whom the table was returned to horizontal before 1 minute; for these subjects, a reading was made at 1 minute and was included in analyses. The tilt table test is a 10-minute assessment performed using a manual or automated tilt table in a specialized laboratory. Subjects were moved onto the horizontal table and secured to the table with straps to prevent injury. After an equilibration period of at least 10 minutes with the subject at rest, the test began and the head of the tilt table was elevated to a 70-degree angle over a period of up to 30 seconds. Symptoms of near syncope were defined as dizziness, lightheadedness, feeling faint, or feeling like the subject might black out.|1 hour post-dose|The Full Analysis Set, defined as subjects who were randomized, received at least one dose of study drug, and had at least one measurement of time to syncope during tilt table testing.||mmHg||Standard Deviation|Mean
751069|NCT00555880|Secondary|Number of Participants With Improvement of Patient CGI-I Scores After Tilt Table Test|"The CGI-I instrument assesses the overall impression of the subject's orthostatic hypotension during the tilt table test by using a 7-point scale, with 1 being Very much improved; 2, Much improved; 3, Slightly improved; 4, No change; 5, Slightly worse; 6, Much worse; and 7, Very much worse. The patient completed the CGI-I after each of the tilt table tests. A patient was assessed as Improved if the score was 1, 2, or 3. The tilt table test is a 10-minute assessment performed using a manual or automated tilt table in a specialized laboratory. Subjects were moved onto the horizontal table and secured to the table with straps to prevent injury. After an equilibration period of at least 10 minutes with the subject at rest, the test began and the head of the tilt table was elevated to a 70-degree angle over a period of up to 30 seconds. Symptoms of near syncope were defined as dizziness, lightheadedness, feeling faint, or feeling like the subject might black out."|1 and 3 hours post-dose|The Full Analysis Set, defined as subjects who were randomized, received at least one dose of study drug, and had at least one measurement of time to syncope during tilt table testing.||participants|||Number
751070|NCT00555880|Secondary|Number of Participants With Improvement of Clinician Clinician's Global Impression- Improvement (CGI-I) Scores After Tilt Table Test|"The CGI-I instrument assesses the overall impression of the subject’s orthostatic hypotension during the tilt table test by using a 7-point scale, with 1 being Very much improved; 2, Much improved; 3, Slightly improved; 4, No change; 5, Slightly worse; 6, Much worse; and 7, Very much worse. The clinician completed the CGI-I after each of the tilt table tests. A patient was assessed as Improved if the score was 1, 2, or 3. The tilt table test is a 10-minute assessment performed using a manual or automated tilt table in a specialized laboratory. Subjects were moved onto the horizontal table and secured to the table with straps to prevent injury. After an equilibration period of at least 10 minutes with the subject at rest, the test began and the head of the tilt table was elevated to a 70-degree angle over a period of up to 30 seconds. Symptoms of near syncope were defined as dizziness, lightheadedness, feeling faint, or feeling like the subject might black out."|1 and 3 hours post-dose|The Full Analysis Set, defined as subjects who were randomized, received at least one dose of study drug, and had at least one measurement of time to syncope during tilt table testing.||participants|||Number
751071|NCT00555880|Secondary|Scores for 6 Items of The OHSA|"The OHSA measures the severity of six symptoms/symptom complexes associated with OH: dizziness, lightheadedness, and feeling faint; problems with vision; weakness; fatigue; trouble concentrating; and head/neck discomfort. Subjects rated symptoms experienced during the tilt table test on an eleven-point scale from none to worst possible. Scores for each subscale range from 0 (no symptoms) to 10 (worst possible symptoms). The OHSA was completed after the tilt table test was over, but was answered with reference to symptoms experienced during testing. The tilt table test is a 10-minute assessment performed using a tilt table in a specialized laboratory. Subjects were moved onto the horizontal table and secured with straps to prevent injury. After an equilibration period with the subject at rest, the test began and the head of the tilt table was elevated to a 70-degree angle over 30 seconds. Symptoms of near syncope were defined as dizziness, lightheadedness, and feeling faint."|Approximately 1 hour post-dose|The Full Analysis Set, defined as subjects who were randomized, received at least one dose of study drug, and had at least one measurement of time to syncope during tilt table testing.||scores on a scale||Standard Deviation|Mean
751072|NCT00555880|Secondary|Total Score of the Orthostatic Hypotension Symptom Assessment (OHSA)|The OHSA measures the severity of six symptoms/symptom complexes associated with orthostatic hypotension. Subjects rated symptoms experienced during the tilt table test on an eleven-point scale from “none” to “worst possible”. The OHSA total score is the sum of six subscales, ranging from 0 (no symptoms) to 60 (worst possible symptoms). The OHSA was completed after the tilt table test was over, but was answered with reference to symptoms experienced during testing. The tilt table test is a 10-minute assessment performed using a manual or automated tilt table in a specialized laboratory. Subjects were moved onto the horizontal table and secured to the table with straps to prevent injury. After an equilibration period with the subject at rest, the test began and the head of the tilt table was elevated to a 70-degree angle over a period of up to 30 seconds. Symptoms of near syncope were defined as dizziness, lightheadedness, feeling faint, or feeling like the subject might black out.|Approximately 1 hour post-dose|The Full Analysis Set, defined as subjects who were randomized, received at least one dose of study drug, and had at least one measurement of time to syncope during tilt table testing.||scores on a scale||Standard Error|Least Squares Mean
751073|NCT00555880|Secondary|Duration of The Effect of Treatment at 3 Hours Post-dose|Duration of effect was defined as the difference in time to onset of near-syncopal symptoms between the first and second tilt table test, conducted at 1 hour and 3 hours post-dose, respectively, at Treatment Visit 2 (time to onset at 3 hours minus time at 1 hour). The tilt table test is a 10-minute assessment performed using a manual or automated tilt table in a specialized laboratory. Subjects were moved onto the horizontal table and secured to the table with straps to prevent injury. After an equilibration period of at least 10 minutes with the subject at rest, the test began and the head of the tilt table was elevated to a 70-degree angle over a period of up to 30 seconds. The endpoint was a confirmed report of a near-syncopal symptom(s) (of sufficient severity that caused the patient to ask that the tilt table be returned to the horizontal position). Symptoms of near syncope were defined as dizziness, lightheadedness, feeling faint, or feeling like the subject might black out.|1 and 3 hours post-dose|The Full Analysis Set, defined as subjects who were randomized, received at least one dose of study drug, and had at least one measurement of time to syncope during tilt table testing.||seconds||Standard Deviation|Mean
751074|NCT00555880|Secondary|Time to Near-syncopal Symptoms at Treatment Visit 1|The tilt table test is a 10-minute assessment performed using a manual or automated tilt table in a specialized laboratory. Subjects were moved onto the horizontal table and secured to the table with straps to prevent injury. After an equilibration period of at least 10 minutes with the subject at rest, the test began and the head of the tilt table was elevated to a 70-degree angle over a period of up to 30 seconds. The head-up tilt table test in this study was conducted 1 hour after administration of the study medication. The endpoint was a confirmed report of a near-syncopal symptom(s) (of sufficient severity that caused the patient to ask that the tilt table be returned to the horizontal position). Symptoms of near syncope were defined as dizziness, lightheadedness, feeling faint, or feeling like the subject might black out.|1 hour post-dose|The Full Analysis Set, defined as subjects who were randomized, received at least one dose of study drug, and had at least one measurement of time to syncope during tilt table testing.||seconds||Standard Error|Least Squares Mean
751075|NCT00555880|Secondary|Time to Onset of Near-syncopal Symptoms in The Per-protocol Population Analysis #2|The tilt table test is a 10-minute assessment performed using a manual or automated tilt table in a specialized laboratory. Subjects were moved onto the horizontal table and secured to the table with straps to prevent injury. After an equilibration period of at least 10 minutes with the subject at rest, the test began and the head of the tilt table was elevated to a 70-degree angle over a period of up to 30 seconds. The head-up tilt table test in this study was conducted 1 hour after administration of the study medication. The endpoint was a confirmed report of a near- syncopal symptom(s) (of sufficient severity that caused the patient to ask that the tilt table be returned to the horizontal position). Symptoms of near syncope were defined as dizziness, lightheadedness, feeling faint, or feeling like the subject might black out. In this outcome measure, the data analyzed are the same as for Outcome Measure 4 but the summary data are presented as least squares mean (standard error).|1 hour post-dose|The Per-protocol set, defined as participants in the Full Analysis Set who completed the study and were protocol compliant.||seconds||Standard Error|Least Squares Mean
751076|NCT00555880|Secondary|Time to Onset of Near-syncopal Symptoms in The Per-protocol Population|The tilt table test is a 10-minute assessment performed using a manual or automated tilt table in a specialized laboratory. Subjects were moved onto the horizontal table and secured to the table with straps to prevent injury. After an equilibration period of at least 10 minutes with the subject at rest, the test began and the head of the tilt table was elevated to a 70-degree angle over a period of up to 30 seconds. The head-up tilt table test in this study was conducted 1 hour after administration of the study medication. The endpoint was a confirmed report of a near-syncopal symptom(s) (of sufficient severity that caused the patient to ask that the tilt table be returned to the horizontal position). Symptoms of near syncope were defined as dizziness, lightheadedness, feeling faint, or feeling like the subject might black out.|1 hour post-dose|The Per-protocol set, defined as participants in the Full Analysis Set who completed the study and were protocol compliant.||seconds||Standard Deviation|Mean
751077|NCT00555880|Primary|Time to Onset of Near-syncopal Symptoms During Tilt Table Testing|The tilt table test is a 10-minute assessment performed using a manual or automated tilt table in a specialized laboratory. Subjects were moved onto the horizontal table and secured to the table with straps to prevent injury. After an equilibration period of at least 10 minutes with the subject at rest, the test began and the head of the tilt table was elevated to a 70-degree angle over a period of up to 30 seconds. The head-up tilt table test in this study was conducted 1 hour after administration of the study medication. The endpoint was a confirmed report of a near-syncopal symptom(s) (of sufficient severity that caused the patient to ask that the tilt table be returned to the horizontal position). Symptoms of near syncope were defined as dizziness, lightheadedness, feeling faint, or feeling like the subject might black out.|1 hour post-dose|The Full Analysis Set (FAS), defined as subjects who were randomized, received at least one dose of study drug, and had at least one measurement of time to syncope during tilt table testing.||seconds||Standard Deviation|Mean
751218|NCT00549900|Primary|Number of Subjects Reporting Serious Adverse Events|Serious adverse events are defined as medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Throughout the study period (up to Month 7)|||Subjects|||Number
751083|NCT00555906|Secondary|Modified Version of Brief Pain Inventory - Short Form (m-BPI-sf) Questionnaire: Phase 2|m-BPI-sf was a questionnaire designed to assess the severity of pain and the impact of pain on daily functions. m-BPI-sf contained questions that assessed pain severity (worst, least, average, right now) and pain interference (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). Each question was answered on a scale ranging from 0 “No pain” to 10 “Pain as bad as you can imagine”. The 4 pain severity questions were averaged to derive an index of pain severity and the 7 function questions were averaged to derive an index for pain interference. Total score range for pain severity and interference indices: 0 to 10, where higher score indicated higher severity/interference.|C1D1 (baseline), C1D8, C1D15, C2D1, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1, C9D1, C10D1, C11D1, C12D1, C13D1, C14D1, C15D1, C16D1, C17D1, C18D1, C19D1, C20D1, C21D1, C22D1, End of Treatment (assessment at early withdrawal occurring up to Cycle 22)|The PRO analysis set included all enrolled participants who received study treatment, had a baseline PRO assessment, and completed at least 1 on-study PRO assessment.'N' signifies those participants who were evaluable for this outcome measure and 'n' signifies participants who were evaluable at specified time points for each arm, respectively.||units on a scale||95% Confidence Interval|Mean
751084|NCT00555906|Secondary|Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2|The QLQ-MY20 consisted of 20 items addressing 4 domains of health-related quality of life (HRQoL) important to participants with multiple myeloma: future perspective (2 items), pain/disease symptoms (6 items), social support /body image (2 items), and treatment side-effects (10 items). All items used 4 point scale (1 'Not at all' to 4 'Very much'). Scores for HRQoL domains were calculated as an average of the individual items, transformed to 0 to 100 range. Higher scores on symptom scales (disease symptoms and side effects of treatment) indicated a higher level of symptoms/problems. Higher scores on functional scales (future perspective and body image) indicated a higher level of QoL/functioning.|C1D1 (baseline), C1D8, C1D15, C2D1, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1, C9D1, C10D1, C11D1, C12D1, C13D1, C14D1, C15D1, C16D1, C17D1, C18D1, C19D1, C20D1, C21D1, C22D1, End of Treatment (assessment at early withdrawal occurring up to Cycle 22)|PRO analysis set included all enrolled participants who received study treatment, had a baseline PRO assessment, and completed at least 1 on-study PRO assessment. Here 'n' signifies those participants who were evaluable at spefied time points for each arm, respectively.||units on a scale||95% Confidence Interval|Mean
751085|NCT00555906|Secondary|European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'); 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores for functional scales, global health status and symptom scales were calculated as an average of individual items, transformed to 0-100 scale; higher score=better level of functioning, health status or greater degree of symptoms. Score of the single items were transformed to 0-100 scale; higher score=greater degree of symptom/difficulty.|C1D1 (baseline), C1D8, C1D15, C2D1, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1, C9D1, C10D1, C11D1, C12D1, C13D1, C14D1, C15D1, C16D1, C17D1, C18D1, C19D1, C20D1, C21D1, C22D1, End of Treatment (assessment at early withdrawal occurring up to Cycle 22)|Patient Reported Outcomes (PRO) analysis set included all enrolled participants who received study treatment, had a baseline PRO assessment, and completed at least 1 on-study PRO assessment. Here 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.||units on a scale||95% Confidence Interval|Mean
751086|NCT00555906|Secondary|Number of Participants With Laboratory Abnormalities: Phase 2|Laboratory parameters included hematology (hemoglobin, platelets, leukocytes, total neutrophils, eosinophils, basophils, lymphocytes, monocytes); liver function (total bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, albumin, total protein); renal function (creatinine, blood urea nitrogen, uric acid); electrolytes (sodium, potassium, chloride, bicarbonate, calcium, magnesium and phosphate); urinalysis (protein and immunology [C reactive protein]), and clinical chemistry (glucose). Total number of participants with laboratory abnormalities was reported.|Cycle 1 Day 1 (baseline) up to 28 days after last dose of palbociclib|SAS included all enrolled participants who received at least 1 dose of study treatment.||participants|||Number
751241|NCT00550173|Secondary|Probability of OS at 12 Months|OS time is censored at the date of last contact for participants who were still alive or lost to follow-up.|Month 12|Q-ITT Population: defined as all participants with nonsquamous histology, who were randomized to therapy.||percent chance of survival||95% Confidence Interval|Number
755237|NCT00593450|Secondary|Area of Lesion||at 1 Year|||mm^2||Standard Deviation|Mean
751087|NCT00555906|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Relationship to Study Medication: Phase 2|An AE was any untoward medical occurrence attributed to study medication in a participant who received study medication. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study medication until 28 days after the last dose of study medication that were absent before treatment or that worsened relative to pretreatment state. All causality AEs included SAEs as well as non-serious AEs, without regard to relationship to the study medication, which occurred during the trial. Treatment-related were adverse events (serious as well as non-serious adverse events) considered related to study medication by the investigator. Number of participants with treatment related TEAEs and all causality TEAEs were summarized.|Cycle 1 Day 1 (baseline) up to 28 days after last dose of palbociclib|SAS included all enrolled participants who received at least 1 dose of study treatment.||participants|||Number
751088|NCT00555906|Secondary|Number of Participants With Adverse Events (AEs) by Severity: Phase 2|An AE was any untoward medical occurrence attributed to study medication in a participant who received study medication. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Adverse events were graded according to the common terminology criteria for adverse events (CTCAE) criteria as 1=mild AE, 2=moderate AE, 3=severe AE, 4=life-threatening or disabling AE, 5=Death related to AE. The most severe grade was used in case of multiple occurrences of the same event.|Cycle 1 Day 1 (baseline) up to 28 days after last dose of palbociclib|Safety analysis set (SAS) included all enrolled participants who received at least 1 dose of study treatment.||participants|||Number
751089|NCT00555906|Secondary|Overall Survival (OS): Phase 2|OS was defined as the time from first dose of study medication to first documentation of death due to any cause. OS was calculated as (the death date or last known alive date [if death date unavailable] minus the date of first dose of study medication plus 1) divided by 30.44.|Cycle 1 Day 1 (baseline) up to end of study (up to Cycle 22 for schedule B), thereafter every 3 months until 1 year after the last dose of palbociclib|RAS included all enrolled participants who received study treatment, had an adequate baseline tumor assessment and measurable disease.||months||95% Confidence Interval|Median
751090|NCT00555906|Secondary|Duration of Objective Response (DR): Phase 2|DR was defined as time from first documentation of objective tumor response (sCR, CR, VGPR or PR) that was subsequently confirmed to first documentation of objective tumor progression or death due to any cause since treatment started. sCR: normal FLC ratio, absence of clonal cells in bone marrow. CR: disappearance of any soft tissue plasmacytomas, <5% plasma cells in bone marrow, negative immunofixation on serum, urine. VGPR: serum, urine M-protein detectable by immunofixation but not on electrophoresis, >=90% reduction in serum M-protein, <100 mg/24hr urine M-protein. PR:>=50% reduction in serum M-protein, reduction in 24-hr urinary M-protein by >=90% or to <200 mg/24 hr. PD: >=25% increase from lowest response level in serum M-component, urine M-component, >=10% bone marrow plasma cell percentage, development of new bone lesions/soft tissue plasmacytomas/increase in size of existing bone lesions, development of hypercalcemia, attributed solely to plasma cell proliferative disorder.|Cycle 1 Day 1 (baseline) up to 28 days after last dose of palbociclib|PRAS was defined as the first consecutive (by first treatment day) participants in RAS (RAS included all enrolled participants who received study treatment, had an adequate baseline tumor assessment and measurable disease) that were response-evaluable. DR was calculated for the subgroup of PRAS participants with objective response.||months||95% Confidence Interval|Median
751091|NCT00555906|Secondary|Progression-free Survival (PFS): Phase 2|"PFS was the time from start of study treatment to date progressive disease was documented or death due to any cause, whichever occurred first. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.44. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death). PD: >=25% increase from lowest response level in serum M-component or urine M-component, >=10% bone marrow plasma cell percentage, definite development of new bone lesions/soft tissue plasmacytomas/definite increase in size of existing bone lesions/soft tissue plasmacytomas, development of hypercalcemia, attributed solely to plasma cell proliferative disorder."|Cycle 1 Day 1 (baseline) up to 28 days after last dose of palbociclib|RAS included all enrolled participants who received study treatment, had an adequate baseline tumor assessment and measurable disease.||months||95% Confidence Interval|Median
751092|NCT00555906|Secondary|Time to Tumor Progression (TTP): Phase 2|TTP was defined as the time from first dose of study medication to first documentation of objective tumor progression. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.44. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD] per IMWGURC). PD: >=25% increase from lowest response level in serum M-component or urine M-component, >=10% bone marrow plasma cell percentage, definite development of new bone lesions/soft tissue plasmacytomas/definite increase in size of existing bone lesions/soft tissue plasmacytomas, development of hypercalcemia, attributed solely to plasma cell proliferative disorder.|Cycle 1 Day 1 (baseline) up to 28 days after last dose of palbociclib|RAS included all enrolled participants who received study treatment, had an adequate baseline tumor assessment and measurable disease.||months||95% Confidence Interval|Median
751108|NCT00556140|Secondary|Depression and Psychosis Remission Rate|This remission rate refers to a Hamilton Depression Rating Scale 17 (HAM-D-17) score of 7 or less and no psychotic symptoms as measured by the Structured Clinical Interview for DMS-IV psychosis module. HAM-D-17 scores range from 0-50 with a score of >23 considered severely depressed and <7 to be mildly to not at all depressed.|Baseline and 7 weeks|"For the 3 participants who did not complete the study, the last observation carried forward technique was used to replace missing data for them."||percent of participants|||Number
751125|NCT00556322|Secondary|Probable Percentage of Participants Remaining Alive and Progression Free at 6 Months|Tumor response was evaluated according to RECIST criteria (version 1.0). Progressive Disease was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Event free estimates were determined using Kaplan-Meier estimates.|6 Months|FAS population||percentage of participants||95% Confidence Interval|Number
751093|NCT00555906|Secondary|Best Overall Response: Phase 1|Best overall response: best confirmed response on study after first study dose as per IMWGURC. sCR: normal FLC ratio, absence of clonal cells in bone marrow. CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas, <5% plasma cells in bone marrow. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis, >=90% reduction in serum M-protein, <100 mg/24 hr urine M-protein. PR: >=50% reduction of serum M-protein, reduction in 24-hr urinary M-protein by >=90% or to <200mg/24 hr. Progressive disease (PD): >=25% increase from lowest response level in serum M-component or urine M-component, >=10% bone marrow plasma cell percentage, definite development of new bone lesions/soft tissue plasmacytomas/definite increase in size of existing bone lesions/soft tissue plasmacytomas, development of hypercalcemia, attributed solely to plasma cell proliferative disorder. Stable disease (SD): criteria for CR, VGPR, PR or PD not met.|Cycle 1 Day 1 (baseline), assessed on Day 1 of every cycle up to end of study (up to Cycle 22 for schedule A and schedule B)|RAS included all enrolled participants who received study treatment, had an adequate baseline tumor assessment and measurable disease.||participants|||Number
751094|NCT00555906|Secondary|Percent Change From Screening in Phosphorylated Retinoblastoma (Rb), Tumor Biomarkers and Soluble Biomarkers Levels: Phase 1||Screening, C1D1(baseline), C1D8, C1D15, C2D1, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1, C9D1, C10D1, C11D1, C12D1, C13D1, C14D1, C15D1, C16D1, C17D1, C18D1, C19D1, C20D1, C21D1, C22D1, End of Treatment (assessment at early withdrawal occurring up to Cycle 22)|Results are not reported because data was present as individual participant listings but not summarized for analysis, as per change in planned analysis.|||||
751095|NCT00555906|Primary|Percentage of Participants With Objective Response (OR): Phase 2|OR: confirmed stringent complete response(sCR),complete response(CR),very good partial response(VGPR) or partial response(PR) as per International Myeloma Working Group Uniform Response Criteria (IMWGURC). sCR: normal serum free light chain (FLC) ratio, absence of clonal cells in bone marrow. CR: disappearance of any soft tissue plasmacytomas, <5 percent (%) plasma cells in bone marrow, negative immunofixation on serum, urine. VGPR: serum, urine M-protein detectable by immunofixation but not on electrophoresis, >= 90% reduction in serum M-protein, <100 mg/24 hour (hr) urine M-protein. PR: >=50% reduction in serum M-protein, reduction in 24-hr urinary M-protein by >=90% or to <200 mg/24 hr, >=50% decrease in difference between involved and uninvolved FLC levels if serum, urine M-protein were unmeasurable, >= 50% reduction in plasma cells, provided baseline bone marrow plasma cell was >=30% if serum, urine M-protein were unmeasurable and serum free light assay was unmeasureable.|Cycle 1 Day 1 (baseline) up to end of study (up to cycle 22 for schedule B)|Primary response analysis set (PRAS) included first consecutive (by first treatment day) participants in response analysis set (RAS=included all enrolled participants who received study treatment, had an adequate baseline tumor assessment and measurable disease) that were response-evaluable.||percentage of participants||95% Confidence Interval|Number
751096|NCT00555906|Primary|Recommended Phase II Dose (RP2D) of PD-0332991: Phase 1|RP2D was determined based on the MTD, safety and tolerability profile of the study treatment.|Day 1 up to Day 28 during Cycle 1 in schedule A, Day 1 up to Day 21 during Cycle 1 in schedule B|DLT analysis set included all enrolled participants who received at least one dose of study treatment and did not have a major deviation in the first cycle.||milligram (mg)|||Number
751097|NCT00555906|Primary|Maximum Tolerated Dose (MTD) of PD-0332991: Phase 1|MTD=highest dose level for which no more than 1 out of 6 participants experienced dose-limiting toxicity (DLT). DLT=any of the following treatment-related events: Absolute neutrophil count (ANC) less than (<)1000/microliter (mcL) (Grade 3 neutropenia) associated with documented infection/fever >=38.5degrees Celsius (C); Grade >=3 nonhematologic treatment-related toxicity, except those that were not maximally treated or considered tolerable, Grade 3 corrected QT interval (QTc) prolongation (QTc >500 millisecond [msec]) in asymptomatic participants even after repeat testing to exclude confounding factors and correction of reversible causes; Delay in the administration of Cycle 2 for more than 1 week of the planned date due to platelet count <25,000/mcL and/or ANC <500/mcL, or due to prolonged nonhematologic toxicities of Grade >=3; Inability to deliver at least 80 percent (%) of the planned PD 0332991 or bortezomib doses during Cycle 1 due to toxicity.|Day 1 up to Day 28 during Cycle 1 in schedule A, Day 1 up to Day 21 during Cycle 1 in schedule B|DLT analysis set included all enrolled participants who received at least one dose of study treatment and did not have a major deviation in the first cycle.||milligram (mg)|||Number
751098|NCT00555997|Secondary|Change in 6-VAS-D Scores During Each Phase.||6 weeks|Forms not analyzable due to insufficient standardization across sites.|||||
751099|NCT00555997|Secondary|Responder/Non-responder|A responder during phase 1 or phase 2 is someone who demonstrated a 50% or greater decrease in HAMD-17 scores during phase 1 or phase 2 (corresponding).|6 weeks|||percentage of patients|||Number
751100|NCT00555997|Primary|Hamilton Depression Rating Scale (HAM-D-17) Scores|Higher numbers represent more symptoms of a major depressive episode. Minimum is 0. Maximum is 52.|6 weeks|||points||Standard Deviation|Mean
751101|NCT00556049|Primary|To Determine the Overall Response Rate of Combination Therapy With Gemcitabine and Sunitinib in Sarcomatoid and/or Poor-risk mRCC Patients as First Line Therapy.||Until disease progression|||percentage of participants|||Number
751102|NCT00556075|Secondary|The Number of Days With Pain as Determined by Data Recorded in the Subject Diaries, Analyzed Between Treatment Groups at the Monthly Visits||days|Zero participants were analyzed because no data were collected due to early termination|||||
751103|NCT00556075|Secondary|Duration of Pain-free Assessments Using the Composite Pain Score as Determined by Data Recorded in the Subject Diaries||days|Zero participants were analyzed because no data were collected due to early termination|||||
751104|NCT00556075|Secondary|Time to Pain-free Assessments Using the Composite Pain Score as Determined by Data Recorded in the Subject Diaries||days|Zero participants were analyzed because no data were collected due to early termination|||||
751105|NCT00556075|Secondary|Difference Between Each Treatment Group in the Subject Diary Composite Pain Score at the Monthly Visits||monthly|Zero participants were analyzed because no data were collected due to early termination|||||
751106|NCT00556075|Primary|Difference Between the 25 mg and 50 mg Proellex Groups and Placebo Group in the Month 4 Subject Diary Composite Pain Score||4 months|Zero participants were analyzed because no data were collected due to early termination|||||
751107|NCT00556075|Primary|Difference Between the 50 mg Proellex Group and Placebo Group in the Month 4 Subject Diary Composite Pain Score||4 months|Zero participants were analyzed because no data were collected due to early termination|||||
751109|NCT00556140|Primary|Depression and Psychosis Response Rate|This response rate refers to the percentage of patients who experienced a 50 percent or greater reduction in symptoms. Specifically, this refers to a 50 percent reduction in Hamilton Depression Rating Scale 17 (HAM-D-17) scores from baseline and no psychotic symptoms as measured by the Structured Clinical Interview for DMS-IV psychosis module. HAM-D-17 scores range from 0-50 with a score of >23 considered severely depressed and <7 to be mildly to not at all depressed.|Baseline and 7 weeks|"For the 3 participants who did not complete the study, the last observation carried forward technique was used to replace missing data for them."||percent of participants|||Number
751110|NCT00556166|Secondary|Number of Episodes of Abdominal Pain, Bloating, and Early Satiety|Data was not analyzed because PI left institution and terminated the study early.|1 year||||||
751111|NCT00556166|Primary|Number of Episodes of Nausea and Vomiting|Data was not analyzed because PI left institution and terminated the study early.|1 year||||||
751112|NCT00556322|Secondary|Probable Percentage of Participants With Deterioration in the TOI at 6 Months as Assessed by FACT-L|TOI is defined as the sum of the scores of the PW, FWB, and LCS of the FACT-L instrument. Trial Outcome Index measures the physical functioning of participants. Time to deterioration in TOI is defined as time from randomization until the earlier of a clinically meaningful decline from baseline in TOI or death on study. The clinically meaningful decline used to determine deterioration in TOI was ≥6-point decline from baseline. Kaplan-Meier estimates were used for analysis.|6 Months|FAS population; Only participants with both a baseline FACT-L assessment and a subsequent FACT-L assessment were included in the analysis.||percentage of participants||95% Confidence Interval|Number
751113|NCT00556322|Secondary|Time to Deterioration in the TOI|TOI is defined as the sum of the scores of the PW, FWB, and LCS of the FACT-L instrument. Trial Outcome Index measures the physical functioning of participants. Time to deterioration in TOI is defined as time from randomization until the earlier of a clinically meaningful decline from baseline in TOI or death on study. The clinically meaningful decline used to determine deterioration in TOI was ≥6- point decline from baseline. Kaplan-Meier estimates were used for analysis.|Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months|FAS population; Only participants with both a baseline FACT-L assessment and a subsequent FACT-L assessment were included in the analysis.||weeks||95% Confidence Interval|Median
751114|NCT00556322|Secondary|Percentage of Participants With Deterioration in the Trial Outcome Index (TOI)|TOI is defined as the sum of the scores of the Physical Well- Being (PWB), Functional Well-Being (FWB), and LCS of the FACT-L instrument. Trial Outcome Index measures the physical functioning of participants. Time to deterioration in TOI is defined as time from randomization until the earlier of a clinically meaningful decline from baseline in TOI or death on study. The clinically meaningful decline used to determine deterioration in TOI was ≥6-point decline from baseline.|Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months|FAS population; Only participants with both a baseline FACT-L assessment and a subsequent FACT-L assessment were included in the analysis.||percentage of participants|||Number
751115|NCT00556322|Secondary|Probable Percentage of Participants With Symptomatic Progression at 6 Months as Assessed by FACT-L|Participants’ responses on the FACT-L were scored according to FACIT measurement system manual. Time to symptom progression is the time from randomization until the earlier of a clinically meaningful decline from baseline in LCS score, or death on study. A change in 2 to 3 points on the LCS is a clinically meaningful change. Meaningful declines in scores as measured by the FACIT instruments have been found to be larger than improvements. Thus, deterioration in disease-related symptoms was defined by the upper bound (3 points) of the range of clinically meaningful change. However, participants who demonstrated early lung cancer progression demonstrated smaller changes from baseline score on the LCS. Therefore, the clinically meaningful decline that was used to determine progression of symptoms in this study was at least 1.5-point decline in LCS score from baseline. Kaplan Meier estimated were used for analysis.|6 Months|FAS population; Only participants with both a baseline FACT-L assessment and a subsequent FACT-L assessment were included in the analysis.||percentage of participants||95% Confidence Interval|Number
751116|NCT00556322|Secondary|Time to Symptomatic Progression Using FACT-L|Participants’ responses on the FACT-L were scored according to FACIT measurement system manual. Time to symptom progression is the time from randomization until the earlier of a clinically meaningful decline from baseline in LCS score, or death on study. A change in 2 to 3 points on the LCS is a clinically meaningful change. Meaningful declines in scores as measured by the FACIT instruments have been found to be larger than improvements. Thus, deterioration in disease-related symptoms was defined by the upper bound (3 points) of the range of clinically meaningful change. However, participants who demonstrated early lung cancer progression demonstrated smaller changes from baseline score on the LCS. Therefore, the clinically meaningful decline that was used to determine progression of symptoms in this study was at least 1.5-point decline in LCS score from baseline. Kaplan Meier estimated were used for analysis.|Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months|FAS population; Only participants with both a baseline FACT-L assessment and a subsequent FACT-L assessment were included in the analysis.||weeks||95% Confidence Interval|Median
751117|NCT00556322|Secondary|Percentage of Participants With Symptomatic Progression Using FACT-L|Participants’ responses on the FACT-L were scored according to the Functional Assessment of Chronic Illness Therapy (FACIT) measurement system manual. Time to symptom progression is the time from randomization until the earlier of a clinically meaningful decline from baseline in LCS score, or death on study. A change in 2 to 3 points on the LCS is a clinically meaningful change. Meaningful declines in scores as measured by the FACIT instruments have been found to be larger than improvements. Thus, deterioration in disease-related symptoms was defined by the upper bound (3 points) of the range of clinically meaningful change. However, participants who demonstrated early lung cancer progression demonstrated smaller changes from baseline score on the LCS. Therefore, the clinically meaningful decline that was used to determine progression of symptoms in this study was at least 1.5-point decline in LCS score from baseline.|Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months|FAS population; Only participants with both a baseline FACT-L assessment and a subsequent FACT-L assessment were included in the analysis.||percentage of participants|||Number
755238|NCT00593450|Secondary|Dye Leakage on Angiogram||at 1 Year|||Participants|||Number
751118|NCT00556322|Secondary|Probable Percentage of Participants Remaining Without Deterioration in Quality of Life at 6 Months as Assessed by FACT-L|The FACT-L measures health related QOL and composes of five domains: the four domains (physical well being, emotional well being, social well being, functional well being) from the FACT-G and the LCS. The FACT-L total score ranges from 0 to 136, higher scores represent better QOL. Kaplan Meier estimates were used for analysis.|6 Months|FAS population; Only participants with both a baseline FACT-L assessment and a subsequent FACT-L assessment were included in the analysis.||percentage of participants||95% Confidence Interval|Number
751119|NCT00556322|Secondary|Time to Deterioration in Quality of Life Using FACT-L|The FACT-L measures health related QOL and composes of five domains: the four domains (physical well being, emotional well being, social well being, functional well being) from the FACT-G and the LCS. The FACT-L total score ranges from 0 to 136, higher scores represent better QOL. Time to deterioration of QoL or symptom progression is defined as time from randomization until either a clinically meaningful decline from baseline in Total FACT-L or, death on study, whichever occurs first. The clinically meaningful decline that was used to determine deterioration in QoL was ≥6-point decline from baseline. Participants without deterioration in QoL at the time of analysis were censored at the time of the last FACT-L assessment. Kaplan-Meier estimate was used to determine time to event.|Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months|FAS population; Only participants with both a baseline FACT-L assessment and a subsequent FACT-L assessment were included in the analysis.||weeks||95% Confidence Interval|Median
751120|NCT00556322|Secondary|Percentage of Participants With Deterioration in Quality of Life Determined Using Functional Assessment of Cancer Therapy - Lung (FACT-L)|The FACT-L measures health related QOL and composes of five domains: the four domains (physical well being, emotional well being, social well being, functional well being) from the Functional Assessment of Cancer Treatment-General scale (FACT-G) and the lung cancer subscale (LCS). The FACT-L total score ranges from 0 to 136, higher scores represent better QOL.|Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months|FAS population; Only participants with both a baseline FACT-L assessment and a subsequent FACT-L assessment were included in the analysis.||percentage of participants|||Number
751121|NCT00556322|Secondary|Percentage of Participants Achieving a Best Overall Response of Confirmed Complete Response (CR) or Partial Response (PR) as Assessed by the Investigator Using RECIST|Best overall response was defined as the best response according to RECIST recorded from the date of randomization until disease progression or recurrence. CR: disappearance of all target lesions; PR: reduction by at least 30% of the sum of the longest diameters of each target lesion, taking the initial sum of the longest diameters as a reference; Stable disease (SD): insufficient tumor reduction to define partial response and/or tumor increase less than that necessary to define tumor progression, taking as a reference the smallest sum of the longest diameter since the start of treatment; Progressive Disease (PD): increase by at least 20% in the sum of LD of each target lesion, taking as a reference the smallest sum of the longest diameters, reported since the start of treatment, or appearance of one or more new lesions. 95% Confidence Interval (CI) for one sample binomial using Pearson-Clopper method. Participants with a missing response were considered non-responders.|Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity or Death or up to 52 months|FAS population||percentage of participants||95% Confidence Interval|Number
751122|NCT00556322|Secondary|Probable Percentage of Participants Remaining Alive and Progression Free at 6 Months in EGFR Positive and Negative Population|EGFR is a gene in the tumor tissues and mutations in this gene have been linked to a variety of tumors. Presence or absence of EGFR was determined by IHC. Tumor response was evaluated according to RECIST criteria (version 1.0). PFS was defined as time from randomization to the date of documented disease progression or death, whichever occurred first in EGFR positive and negative populations. Participants without progression were censored at the date of last tumor assessment where non progression was documented. If a participant receives a second anti-cancer therapy without prior documentation of disease progression, the participant was censored at the date of last tumor assessment before starting new chemotherapy. Event free estimates were determined using Kaplan-Meier estimates.|6 Months|FAS population; n=number of EGFR positive or negative participants who remained at risk||percentage of participants||95% Confidence Interval|Number
751123|NCT00556322|Secondary|PFS in EGFR Positive and Negative Population (Data Cutoff 07 September 2010)|EGFR is a gene in the tumor tissues and mutations in this gene have been linked to a variety of tumors. Presence or absence of EGFR was determined by IHC. PFS was defined as time from randomization to the date of documented disease progression or death, whichever occurred first in EGFR positive and negative populations. Participants without progression were censored at the date of last tumor assessment where non progression was documented. If a participant receives a second anti-cancer therapy without prior documentation of disease progression, the participant was censored at the date of last tumor assessment before starting new chemotherapy. Kaplan-Meier estimates were used for analysis.|Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity or Until Data Cut off (07 September 2010) up to 52 months|FAS population; Only Participants with confirmed status of EGFR were included in the analysis; number of participants who were EGFR positive or negative||weeks||95% Confidence Interval|Median
751124|NCT00556322|Secondary|Percentage of Participants With Disease Progression or Death in EGFR Positive and Negative Population (Data Cut Off 07 September 2010)|EGFR is a gene in the tumor tissues and mutations in this gene have been linked to a variety of tumors. Presence or absence of EGFR was determined by IHC.Tumor response was evaluated according to RECIST criteria (version 1.0). Progressive Disease was defined as At least a 20 % increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months|FAS population; Only participants with confirmed presence or absence of EGFR were included in the analysis. n=number of participants who were EGFR positive or negative||percentage of participants|||Number
751257|NCT00550394|Primary|Drinks Per Day|Change in self-reported drinks/day (drinks consumed divided by the number of days during that study period).|baseline to 12 weeks or endpoint (up to 11 weeks)|||Drinks per day||Standard Deviation|Mean
755239|NCT00593450|Secondary|Fluid on Optical Coherence Tomography||at 1 Year|||Participants|||Number
751126|NCT00556322|Secondary|Progression-Free Survival (PFS) in All Participants (Data Cutoff 07 September 2010)|Tumor response was evaluated according to RECIST criteria (version 1.0). Progressive Disease was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PFS was defined as time from randomization to the date of documented disease progression or death, whichever occurred first. Participants without progression were censored at the date of last tumor assessment where non progression was documented. If a participant receives a second anti-cancer therapy without prior documentation of disease progression, the participant was censored at the date of last tumor assessment before starting new chemotherapy.|Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity or Until Data Cut off (07 September 2010) up to 52 months|FAS population||weeks||95% Confidence Interval|Median
751127|NCT00556322|Secondary|Percentage of Participants With Disease Progression or Death (All Participants; Data Cut Off 07 September 2010)|Tumor response was evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria (version 1.0). Progressive Disease was defined as at least a 20 percent (%) increase in the sum of the Longest Diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. The primary analysis of PFS used objective progression (RECIST) plus clinical progression (based on relevant clinical findings - if any). A further assessment of PFS was made on objective (radiological) progression. If clinical progression was diagnosed first, the participant was censored at the date of the last tumor assessment, where non-progression was documented.|Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity or Until Data Cut off (07 September 2010) up to 52 months|FAS population||percentage of participants|||Number
751128|NCT00556322|Secondary|Probable Percentage of Participants Remaining Alive at 1 Year in the EGFR Positive and Negative Population|EGFR is a gene in the tumor tissues and mutations in this gene have been linked to a variety of tumors. Presence or absence of EGFR was determined by IHC. OS was determined from the date of randomization to the date of death irrespective of the cause of death in EGFR positive and negative populations. Kaplan-Meier estimates were used for analysis.|1 Year|FAS population; n=number of EGFR positive or negative participants remaining at risk||percentage of participants||95% Confidence Interval|Number
751129|NCT00556322|Secondary|Duration of OS in EGFR Positive and Negative Population|EGFR is a gene in the tumor tissues and mutations in this gene have been linked to a variety of tumors. Presence or absence of EGFR was determined by IHC. OS was determined from the date of randomization to the date of death irrespective of the cause of death in EGFR positive and negative populations. Kaplan-Meier estimates were used for analysis.|Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Death or Until Data Cut off (07 September 2010) up to 52 months|FAS population; Only participants with confirmed presence or absence of EGFR were included in the analysis. n=number of participants who were EGFR positive or negative||months||95% Confidence Interval|Median
751130|NCT00556322|Secondary|Percentage of Participants Who Died in Epidermal Growth Factor Receptor (EGFR) Positive and Negative Population|EGFR is a gene in the tumor tissues and mutations in this gene have been linked to a variety of tumors. Presence or absence of EGFR was determined by immunohistochemistry (IHC). OS was determined from the date of randomization to the date of death irrespective of the cause of death in EGFR positive and negative populations. Kaplan-Meier estimates were used for analysis.|Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Death or Until Data Cut off (07 September 2010) up to 52 months|FAS population; Only participants with confirmed presence or absence of EGFR were included in the analysis. number (n) equals (=) number of participants who were EGFR positive or negative||percentage of participants|||Number
751131|NCT00556322|Primary|Probable Percentage of Participants Remaining Alive at 1 Year|OS was determined from the date of randomization to the date of death irrespective of the cause of death. Kaplan-Meier estimates were used for analysis.|1 Year|FAS population||percentage of participants||95% Confidence Interval|Number
751132|NCT00556322|Primary|Duration of Overall Survival in All Participants (Data Cutoff 07 September 2010)|OS was determined from the date of randomization to the date of death irrespective of the cause of death. Kaplan-Meier estimates were used for analysis.|Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Death or Until Data Cut off (07 September 2010) up to 52 months|FAS population||months||95% Confidence Interval|Median
751133|NCT00556322|Primary|Percentage of Participants Who Died (All Participants; Data Cutoff: 07 September 2010)|Overall survival (OS) was determined from the date of randomization to the date of death irrespective of the cause of death.|Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 or Death and Every 12 Weeks until Death or Data Cut off (07 September 2010) up to 52 months|FAS population||percentage of participants|||Number
751153|NCT00549601|Secondary|Overall Caregiver Satisfaction With Treatment|Caregivers were asked to rate their overall degree of satisfaction with the Alzheimer's disease treatment on a scale of 1 to 5 (1 “Very good” – 5 “Very poor”) at the end of the study (Month 3). A higher score indicates less satisfaction.|At end of study (Month 3)|The Safety population included all randomized patients who received at least one dose of the study medication.||Participants|||Number
751143|NCT00556400|Secondary|Total Number of Bleeding Days During the First 7 Days.||1 week|Early termination because of insufficient accrual. With only one study participant, data could not be analyzed.|||||
751144|NCT00556400|Secondary|Proportion Who Stop Uterine Bleeding by Day 14.||2 weeks|Early termination because of insufficient accrual. With only one study participant, data could not be analyzed.|||||
751145|NCT00556400|Primary|Stop Vaginal Bleeding or Spotting.||1 week|Early termination because of insufficient accrual. With only one study participant, data could not be analyzed.|||||
751146|NCT00556426|Secondary|Incidence of Filter Fracture|occurrence of fracture assessed at retrieval by the Investigator (broken filter arms, legs, or other components)|at 6 months or at retrieval of the filter|adequate imaging was available to assess filter integrity in 83 of the 100 participants.||number of fractured filters|||Number
751147|NCT00556426|Secondary|Filter Migration > 2cm|Percentage of subjects experiencing filter migrations from the initial placement position of 2cm or more.|30 days post retrieval or 6 months following filter placement|Migration measurement made for 58 retrieved subjects, 22 non-retrieved subjects reaching the 6 month visit, and 2 non-retrieved subjects with attempted retrievals and imaging.||Percent Subjects with Filter Migration|||Number
751148|NCT00556426|Primary|Percentage of Participants With Adverse Events Through 30 Days Post Retrieval|Adverse events occurring at the time of retrieval through 30 days post filter retrieval procedure|30 days post retrieval|61 of 100 patients underwent filter retrieval during the study.||percentage of participants||95% Confidence Interval|Number
751149|NCT00556426|Primary|Clinical Success (Retrieval)|technical success without subsequent damage to the cava wall or other retrieval-related complications requiring intervention.|Time of Retrieval or through 6 months of implantation|61/100 patients experienced filter retrieval during the study||participants|||Number
751150|NCT00556426|Primary|Technical Success (Retrieval)|Technical success for retrieval of the filter such that the entire filter is removed.|1 month post filter retrieval or through 6 months following implantation|61 of 100 patients enrolled underwent filter retrieval during the study.||participants|||Number
751151|NCT00549601|Secondary|Change in the Total Mini-Mental State Examination (MMSE) Score From Baseline to Month 1 and Month 3|The Mini Mental State Examination (MMSE) was used to evaluate the patient's cognitive status and how it progressed over time. The 35-point version used in this study was made up of five sections: orientation, fixation, attention and calculation, memory and language, and constructional praxis. The total score for each patient was obtained by adding the score from each of the above sections. The individual receives 1 point for each correct answer. The total score can range from 0 to 30, with a higher score indicating better function. A positive change score indicates improvement.|Baseline to Month 1 and Month 3|The Safety population was made up of all the randomized patients who had taken at least one dose of the study medication.||Units on a scale||Standard Deviation|Mean
751152|NCT00549601|Secondary|Overall Patient Satisfaction With Treatment|Patients were asked to rate their overall degree of satisfaction with the Alzheimer's disease treatment on a scale of 1 to 5 (1 “Very good” - 5 “Very poor”) at the end of the study (Month 3). A higher score indicates less satisfaction.|At end of study (Month 3)|The Safety population included all randomized patients who received at least one dose of the study medication.||Participants|||Number
751154|NCT00549601|Secondary|Percentage of Patients With at Least 1 AE of Any Kind Recorded During the Period of the Study.|Adverse events were coded using the medical dictionary MedDRA v11.0 and the number of patients who suffered an AE were described by system organ class (SOC) and preferred term (PT). They were also tabulated by severity, relationship with study treatment, and action taken.|Baseline to end of study (Month 3)|The Safety population included all randomized patients who received at least one dose of the study medication.||Percentage of participants|||Number
751155|NCT00549601|Secondary|Percentage of Patients With an AE Involving the Skin (Local Tolerance) Recorded Over the Course of the Study Period (Patch Groups Only)|Adverse events involving the skin included urticaria, pruritus, erythema, and pigmentation disorder. Only the groups administered rivastigmine transdermally via patch were analyzed. The adverse events were coded using the medical dictionary MedDRA v11.0 and the number of patients who suffered an AE were described by system organ class (SOC) and preferred term (PT).|Baseline to end of study (Month 3)|The Safety population included all randomized patients who received at least one dose of the study medication.||Percentage of participants|||Number
751156|NCT00549601|Primary|Percentage of Patients Who Had a Gastrointestinal Adverse Event (AE) at Any Time During the Study|Gastrointestinal adverse events (including nausea, vomiting, and diarrhea) were coded using the medical dictionary MedDRA v11.0 and the number of patients who suffered an AE were described by system organ class (SOC) and preferred term (PT).|Baseline to end of study (Month 3)|The Safety population included all randomized patients who received at least one dose of the study medication.||Percentage of participants|||Number
751157|NCT00549640|Secondary|The Change in the Average Nicotine Withdrawal Symptom Score From Baseline to 14 Days Post Target Quit Date.|The average composite nicotine withdrawal score (using Minnesota Nicotine Withdrawal Scale) change from baseline for the first 14 days following target quit date. Scale scores range from 0 (none) to 4 (severe).|baseline and 14 days|Analysis was restricted to subjects who had diary information available for the first 14 days following target quit date||units on a scale||Standard Deviation|Mean
751158|NCT00549640|Primary|Number of Subjects Biochemically Confirmed to be Abstinent From Smoking at End of Study|Number of subject who self report no smoking in the last 7 days (7-day point prevalence)at the end of study (week 24) and are biochemically confirmed (expired carbon monoxide <= 8 ppm)|6 months|Intention to treat (ITT). subject who discontinued study participation were counted as using tobacco.||participants|||Number
751159|NCT00549640|Primary|Number of Subjects Biochemically Confirmed to be Abstinent From Smoking at End of Treatment.|Number of subject who self report no smoking in the last 7 days (7-day point prevalence)at the end of the medication phase (week 8) and are biochemically confirmed (expired carbon monoxide <= 8 ppm)|8 weeks|Intention to Treat. subjects with missing information were assumed to be using tobacco.||participants|||Number
751160|NCT00549718|Primary|Change in Total PANSS Score From Baseline to the End of the Double Blind Phase|The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.|6 weeks|The primary population for the efficacy analysis was the Intent-to-Treat (ITT) population. All subjects who were randomized, received at least one dose of study medication, and have a Baseline efficacy measurement and at least one post-Baseline efficacy measurement, were in the efficacy analysis in the treatment group to which they were randomized.||scores on a scale||95% Confidence Interval|Least Squares Mean
751161|NCT00549718|Secondary|CGI-S From Baseline to the End of the Double-blind Treatment|Clinical Global Impression of Severity is a clinician-rated assessment of the subject's current illness state on a 7 point scale, where a higher score is associated with greater illness severity. The scale has a single item measured on a 7 point scale from 1 (‘normal’, not ill) to 7 (extremely ill).|6 weeks|The primary population for the efficacy analysis was the Intent-to-Treat (ITT) population.All subjects who were randomized, received at least one dose of study medication, and have a Baseline efficacy measurement and at least one post-Baseline efficacy measurement,were in the efficacy analysis in the treatment group to which they were randomized.||scores on a scale||95% Confidence Interval|Least Squares Mean
751162|NCT00549757|Other Pre-specified|Percentage of Participants With Angioedema/Angioedema-like Events or Colorectal Events (Extension Phase)|AEs of special interest were reported according to a post-marketing commitment to Health Authorities and included angioedema/angioedema-like events and colorectal events/ procedures.|From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)|Extension-phase Analysis Set (EAS) – All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/end of treatment (EOT).||percentage of participants|||Number
751163|NCT00549757|Other Pre-specified|Mean Changes in Estimated Glomerular Filtration Rate (eGFR) From Baseline to Month 3 and Month 6 (Core : Active Treatment Phase)|"The eGFR calculation was based on the Abbreviated Modification of Diet in Renal Disease (MDRD) Study Equation. Using this method, the applicable MDRD formula to calculate eGFR was as follows:
Estimated GFR (mL/min/1.73 m^2) = 175 x (serum creatinine in mg/dL) -1.154 x (Age in years) -0.203 x (0.742 if female) x (1.210 if Black)
Mean changes in eGFR from baseline to month 3 and month 6 were included for analysis. The LS Mean and Standard Error were based on an ANCOVA repeated-measure model with treatment, visit, treatment-by-visit and baseline eGFR as effect terms."|Baseline to Month 3 and Month 6|Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. At each visit (baseline, Month 3 and Month 6) , only patients with values at both baseline and post-baseline time point are included.||mL/min/1.73 m^2||Standard Error|Least Squares Mean
751164|NCT00549757|Other Pre-specified|Change From Baseline in Urinary Albumin to Creatinine Ratio (UACR) to Month 6 and to Last Measurement (Core : Active Treatment Phase)|"Baseline is the geometric mean of last 3 measurements before visit 3, Post-baseline value is the geometric mean of last 3 measurements during each visit.
Change from Baseline = Post - Baseline."|Baseline, Month 6 , last measurement (maximum at 50 months)|Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Last observation carried forward (LOCF) computation technique was used for month 6 data. At each visit, only patients with values at both baseline and this time point are included.||mg/mmol||95% Confidence Interval|Geometric Mean
755240|NCT00593450|Secondary|Retinal Thickness Plus Subfoveal-fluid Thickness Change From Baseline at Fovea||Baseline and 1 Year|||μm||Standard Deviation|Mean
751165|NCT00549757|Other Pre-specified|Percentage of Participants With Angioedema/Angioedema-like or Colorectal Events (Core : Active Treatment Phase)|AEs of special interest were reported according to a post-marketing commitment to Health Authorities and included angioedema/angioedema-like events and colorectal events/ procedures|Time from randomization to the first event (Maximum 50 months)|Safety Set (SAF) - All patients who received at least one dose of trial medication. Patients were analyzed according to the treatment they received.||percentage of participants|||Number
751166|NCT00549757|Primary|Percentage of Participants With All Cause Mortality (Extension Phase)||from cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)|Extension-phase Analysis Set (EAS) – All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/EOT.||percentage of participants|||Number
751167|NCT00549757|Primary|Percentage of Participants With Unplanned Hospitalization for Heart Failure (Extension Phase)||From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)|Extension-phase Analysis Set (EAS) – All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/EOT.||percentage of participants|||Number
751168|NCT00549757|Primary|Percentage of Participants Doubling of Baseline Serum Creatinine Concentration, Sustained for at Least One Month (Extension Phase)|To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory. The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL.|From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)|Extension-phase Analysis Set (EAS) – All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/EOT.||percentage of participants|||Number
751169|NCT00549757|Primary|Percentage of Participants With Onset of End-stage Renal Disease (ESRD) (Extension Phase)|ESRD is defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 µmol per liter) or renal death|From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)|||percentage of participants|||Number
751170|NCT00549757|Primary|Percentage of Participants With Fatal/Non-fatal Stroke (Extension Phase)||From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)|Extension-phase Analysis Set (EAS) – All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/EOT.||percentage of participants|||Number
751171|NCT00549757|Primary|Percentage of Participants Fatal/Non-fatal Myocardial Infarction (MI) (Extension Phase)||From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 month in average)|Extension-phase Analysis Set (EAS) – All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/EOT.||percentage of participants|||Number
751172|NCT00549757|Primary|Percentage of Participants With Resuscitated Sudden Death (Extension Phase)||From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)|Extension-phase Analysis Set (EAS) – All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/EOT.||percentage of participants|||Number
751173|NCT00549757|Primary|Percentage of Participants With Cardiovascular (CV) Death (Extension Phase)||from cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)|Extension-phase Analysis Set (EAS) – All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/EOT.||percentage of participants|||Number
751174|NCT00549757|Primary|Percentage of Participants With Occurrence of Primary Composite Endpoint (Extension Phase)|"Occurrence was defined as the first event of the following composite primary endpoint:
Cardiovascular (CV) death
Resuscitated sudden death
Non-fatal myocardial infarction (MI)
Non-fatal stroke
Unplanned hospitalization for heart failure (HF)
Onset of end-stage renal disease (ESRD) or death due to renal failure. Onset of ESRD was defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 μmol/L), sustained for at least a month.
Doubling of baseline serum creatinine concentration, sustained for at least one month. To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory. The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL."|From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)|Extension-phase Analysis Set (EAS) – All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/EOT.||percentage of participants|||Number
751175|NCT00549757|Primary|Percentage of Participants With All Cause Mortality (Core: Active Treatment Phase)||Time from randomization to the first event (Maximum 50 months)|Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study.||percentage of participants|||Number
751176|NCT00549757|Primary|Percentage of Participants With Unplanned Hospitalization for Heart Failure (Core: Active Treatment Phase)||Time from randomization to the first event (Maximum 50 Months)|Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study.||percentage of participants|||Number
751177|NCT00549757|Primary|Percentage of Participants With Doubling of Baseline Serum Creatinine Concentration, Sustained for at Least One Month (Core: Active Treatment Phase)|To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory. The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL.|Time from randomization to the first event (Maximum 50 Months)|Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study.||percentage of participants|||Number
751201|NCT00549783|Secondary|Activities of Daily Living Quality of Life (QOL) Score at Week 52|Activities of daily living QOL score at week 52 as measured by SF-12 Physical Component (PCS-12). The SF-12 consists of 12 questions on various health questions. The PCS-12 is a sub-score calculated from the SF-12 total score based on the physical health questions where 0 is worse and 100 is best. A higher score indicates a better health state.|Baseline, Week 52|Intent-to-treat, which consists of all patients who were randomized (started study) and received a baseline injection.||Scores on a Scale||Standard Deviation|Mean
751178|NCT00549757|Secondary|Percentage of Participants With Occurrence of Secondary Renal Composite Endpoint (Extension Phase)|"Occurrence was defined as the first event of the following secondary renal composite endpoint:
Onset of end-stage renal disease (ESRD) or death due to renal failure. Onset of ESRD was defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 μmol/L), sustained for at least a month.
Doubling of baseline serum creatinine concentration, sustained for at least one month. To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory. The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL."|From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)|Extension-phase Analysis Set (EAS) – All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/end of treatment (EOT).||percentage of participants|||Number
751179|NCT00549757|Secondary|Percentage of Participants With Occurrence of Secondary Cardiovascular Composite Endpoint (Extension Phase)|"Occurrence was defined as the first event of the following secondary cardiovascular composite endpoint:
Cardiovascular (CV) death
Resuscitated sudden death
Non-fatal myocardial infarction (MI)
Non-fatal stroke
Unplanned hospitalization for heart failure (HF)"|From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)|Extension-phase Analysis Set (EAS) – All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/end of treatment (EOT).||percentage of participants|||Number
751180|NCT00549757|Secondary|Percentage of Participants With Occurrence of Secondary Renal Composite Endpoint (Core: Active Treatment Phase)|"Occurrence was defined as the first event of the following secondary renal composite endpoint:
Onset of end-stage renal disease (ESRD) or death due to renal failure. Onset of ESRD was defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 μmol/L), sustained for at least a month.
Doubling of baseline serum creatinine concentration, sustained for at least one month. To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory.The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL."|Time from randomization to the first event (Maximum 50 months)|Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study.||percentage of participants|||Number
751181|NCT00549757|Secondary|Percentage of Participants With Occurrence of Secondary Cardiovascular Composite Endpoint (Core: Active Treatment Phase)|"Occurrence was defined as the first event of the following secondary cardiovascular composite endpoint:
Cardiovascular (CV) death
Resuscitated sudden death
Non-fatal myocardial infarction (MI)
Non-fatal stroke
Unplanned hospitalization for heart failure (HF)"|Time from randomization to the first event (Maximum 50 months)|Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study.||percentage of participants|||Number
751182|NCT00549757|Primary|Percentage of Participants With Onset of End-stage Renal Disease (ESRD) (Core: Active Treatment Phase)|ESRD is defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 µmol per liter) or renal death|Time from randomization to the first event (Maximum 50 Months)|Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study.||percentage of participants|||Number
751183|NCT00549757|Primary|Percentage of Participants With Fatal/Non-fatal Stroke (Core: Active Treatment Phase)||Time from randomization to the first event (Maximum 50 Months)|Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study.||percentage of participants|||Number
751184|NCT00549757|Primary|Percentage of Participants With Fatal/Non-fatal Myocardial Infarction (MI) (Core: Active Treatment Phase)||Time from randomization to the first event (Maximum 50 Months)|Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study.||percentage of participants|||Number
751185|NCT00549757|Primary|Percentage of Participants With Resuscitated Sudden Death (Core: Active Treatment Phase)|Resuscitated sudden death was adjudicated when a subject experiences sudden death or cardiac arrest and is successfully resuscitated by cardioversion, defibrillation or cardiopulmonary resuscitation with a meaningful recovery of consciousness. This definition excludes known transient losses of consciousness such as seizure or vasovagal episodes that do not reflect significant cardiac dysfunction.|Time from randomization to the first event (Maximum 50 Months)|Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study.||percentage of participants|||Number
751186|NCT00549757|Primary|Percentage of Participants With Cardiovascular (CV) Death (Core: Active Treatment Phase)||Time from randomization to the first event (Maximum 50 months)|Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study.||percentage of participants|||Number
751202|NCT00549783|Secondary|Activities of Daily Living Quality of Life (QOL) Score at Week 24|Activities of daily living QOL score at week 24 (or 10 weeks post second injection) as measured by SF-12 Physical Component (PCS-12). The SF-12 consists of 12 questions on various health questions. The PCS-12 is a sub-score calculated from the SF-12 total score based on the physical health questions where 0 is worse and 100 is best. A higher score indicates a better health state.|Baseline, Week 24|Intent-to-treat, which consists of all patients who were randomized (started study) and received a baseline injection.||Scores on a Scale||Standard Deviation|Mean
751240|NCT00550147|Primary|RAAPP: Rating of Aggression Against People and/or Property Scale|The RAAPP is a global rating scale of aggression that is completed by a clinician based on interview and observation data. It is scored from 1 (no aggression reported) to 5 (intolerable behavior).|See Arm/Group - Repeated Measures|Participants were those who qualified for the augmentation portion of the study (inadequate response to Oros MPH alone). Analysis was per protocol (intent-to-treat, LOCF).||units on a scale||Standard Deviation|Mean
751187|NCT00549757|Primary|Percentage of Participants With Occurrence of Primary Composite Endpoint (Core : Active Treatment Phase)|"Occurrence was defined as the first event of the following composite primary endpoint:
Cardiovascular (CV) death
Resuscitated sudden death
Non-fatal myocardial infarction (MI)
Non-fatal stroke
Unplanned hospitalization for heart failure (HF)
Onset of end-stage renal disease (ESRD) or death due to renal failure. Onset of ESRD was defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 μmol/L), sustained for at least a month.
Doubling of baseline serum creatinine concentration, sustained for at least one month. To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory. The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL."|Time from randomization to the first event (Maximum 50 months)|Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study.||percentage of participants|||Number
751188|NCT00549770|Secondary|Percentage of Participants Who Achieved Successful Control in msSBP|Successful control in msSBP is defined as <140 mmHg.|8 weeks|Intent-to-treat (ITT): The ITT included all randomized participants who had a baseline and at least one post-baseline efficacy measuremet during the 8-week core treatment period.||Percentage of participants|||Number
751189|NCT00549770|Secondary|Percentage of Participants Who Achieved Successful Control in msDBP|Successful control in msDBP is defined as msDBP <90 mmHg.|8 weeks|Intent-to-treat (ITT): The ITT included all randomized participants who had a baseline and at least one post-baseline efficacy measuremet during the 8-week core treatment period.||Percentage of participants|||Number
751190|NCT00549770|Secondary|Percentage of Participants Who Achieved a Successful Response in msSBP|Successful response in msSBP is defined as msSBP <140 mmHg or a reduction ≥ 20 mmHg from baseline.|8 weeks|Intent-to-treat (ITT): The ITT included all randomized participants who had a baseline and at least one post-baseline efficacy measuremet during the 8-week core treatment period.||Percentage of participants|||Number
751191|NCT00549770|Secondary|Percentage of Participants Who Achieved a Successful Response in msDBP|Successful response in msDBP is defined as msDBP <90 mmHg or a reduction ≥ 10 mmHg from baseline.|8 weeks|Intent-to-treat (ITT): The ITT included all randomized participants who had a baseline and at least one post-baseline efficacy measuremet during the 8-week core treatment period.||Percentage of participants|||Number
751192|NCT00549770|Secondary|Change From Baseline in Nighttime maDBP and maSBP|Hourly mean ambulatory DBP and SBP post-dosing was calculated for each post-dosing hour over 24 hours by taking the average of the readings taken in the corresponding post-dosing hour at randomization and at week 8. Nighttime mean SBP and DBP were the averages of the hourly means between 10 pm and 6 am.|baseline, 8 weeks|Participants from the ABPM subset, who had both baseline nighttime and week 8 nighttime values, were included in the analysis only.||mmHg||Standard Error|Least Squares Mean
751193|NCT00549770|Secondary|Change From Baseline in Daytime maDBP and maSBP|Hourly mean ambulatory DBP and SBP post-dosing was calculated for each post-dosing hour over 24 hours by taking the avergae of the readings taken in the corresponding post-dosing hour at randomization and at week 8. Daytime mean SBP and DBP were the averages of the hourly means between 6 am and 10 pm.|baseline, 8 weeks|Ambulatory Blood Pressure Monitoring (ABPM) Subset: The ABPM subest included all ITT participants who had both baseline and week 8 ABPM values.||mmHg||Standard Error|Least Squares Mean
751194|NCT00549770|Secondary|Change From Baseline in 24-hour Mean Ambulatory DBP (maDBP) and maSBP|Hourly mean ambulatory DBP and SBP post-dosing was calculated for each post-dosing hour over 24 hours by taking the average of the readings taken in the corresponding post-dosing hour at randomization and at week 8.|baseline, 8 weeks|Ambulatory Blood Pressure Monitoring (ABPM) Subset: The ABPM subest included all ITT participants who had both baseline and week 8 ABPM values.||mmHg||Standard Error|Least Squares Mean
751195|NCT00549770|Secondary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)|Sitting BP measurements were performed at screening through the end of the study at every study visit.|baseline, week 8|Intent-to-treat (ITT): The ITT included all randomized participants who had a baseline and at least one post-baseline efficacy measuremet during the 8-week core treatment period.||mmHg||Standard Error|Least Squares Mean
751196|NCT00549770|Primary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)|Sitting BP measurements were performed at screening through the end of the study at every study visit. A negative change from baseline indicates improvement.|baseline, week 8|Intent-to-treat (ITT): The ITT included all randomized participants who had a baseline and at least one post-baseline efficacy measuremet during the 8-week core treatment period.||mmHg||Standard Error|Least Squares Mean
751197|NCT00549783|Secondary|Direct Costs for the United Kingdom|Direct healthcare costs associated with spasticity in cases where the primary reason for the use of the identified health care resource was the treatment of spasticity, or any related complications. Direct healthcare costs are presented in the local currency for the United Kingdom.|52 Weeks|Intent-to-treat, which consists of all patients in the United Kingdom who were randomized (started study) and received a baseline injection.||British Pound (GBP)||Standard Deviation|Mean
751198|NCT00549783|Secondary|Direct Costs for Sweden|Direct healthcare costs associated with spasticity in cases where the primary reason for the use of the identified health care resource was the treatment of spasticity, or any related complications. Direct healthcare costs are presented in the local currency for Sweden.|52 Weeks|Intent-to-treat, which consists of all patients in Sweden who were randomized (started study) and received a baseline injection.||Swedish Krona (SEK)||Standard Deviation|Mean
751199|NCT00549783|Secondary|Direct Costs for Germany|Direct healthcare costs associated with spasticity in cases where the primary reason for the use of the identified health care resource was the treatment of spasticity, or any related complications. Direct healthcare costs are presented in the local currency for Germany.|52 Weeks|Intent-to-treat, which consists of all patients in Germany who were randomized (started study) and received a baseline injection.||Euro (EUR)||Standard Deviation|Mean
751200|NCT00549783|Secondary|Direct Costs for Canada|Direct healthcare costs associated with spasticity in cases where the primary reason for the use of the identified health care resource was the treatment of spasticity, or any related complications. Direct healthcare costs are presented in the local currency for Canada.|52 Weeks|Intent-to-treat, which consists of all patients in Canada who were randomized (started study) and received a baseline injection.||Canadian dollar (CAD)||Standard Deviation|Mean
751203|NCT00549783|Secondary|Activities of Daily Living Quality of Life (QOL) Score at Week 12|Activities of Daily Living QOL score at week 12 as measured by SF-12 Physical Component (PCS-12). The SF-12 consists of 12 questions on various health questions. The PCS-12 is a sub-score calculated from the SF-12 total score based on the physical health questions where 0 is worse and 100 is best. A higher score indicates a better health state.|Baseline, Week 12|Intent-to-treat, which consists of all patients who were randomized (started study) and received a baseline injection.||Scores on a Scale||Standard Deviation|Mean
751204|NCT00549783|Secondary|Patient Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Functional Goal at Week 52|Patient assessment of success, as determined by percentage of patients who achieve their principal functional goal (i.e., a score of 0 to +2 inclusive on the goal attainment scale [GAS]) at week 52. The GAS is a 6-point scale where -3 means function is worse than at start, 0 means the expected goal was attained, and +2 is much better function than expected.|Week 52|Intent-to-treat, which consists of all patients who were randomized (started study) and received a baseline injection.||Percentage of Patients|||Number
751205|NCT00549783|Secondary|Patient Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Functional Goal at Week 24|Patient assessment of success, as determined by percentage of patients who achieve their principal functional goal (i.e., a score of 0 to +2 inclusive on the goal attainment scale [GAS]) at week 24 (or 10 weeks post second injection). The GAS is a 6-point scale where -3 means function is worse than at start, 0 means the expected goal was attained, and +2 is much better function than expected.|Week 24|Intent-to-treat, which consists of all patients who were randomized (started study) and received a baseline injection.||Percentage of Patients|||Number
751206|NCT00549783|Secondary|Patient Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Functional Goal at Week 12|Patient assessment of success, as determined by percentage of patients who achieve their principal functional goal (i.e., a score of 0 to +2 inclusive on the goal attainment scale [GAS]) at week 12. The GAS is a 6-point scale where -3 means function is worse than at start, 0 means the expected goal was attained, and +2 is much better function than expected.|Week 12|Intent-to-treat, which consists of all patients who were randomized (started study) and received a baseline injection.||Percentage of Patients|||Number
751207|NCT00549783|Secondary|Physician Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Functional Goal at Week 52|Physician assessment of success, as determined by percentage of patients who achieve their principal functional goal (i.e., a score of 0 to +2 inclusive on the goal attainment scale [GAS]) at week 52. The GAS is a 6-point scale where -3 means function is worse than at start, 0 means the expected goal was attained, and +2 is much better function than expected|Week 52|Intent-to-treat, which consists of all patients who were randomized (started study) and received a baseline injection.||Percentage of Patients|||Number
751208|NCT00549783|Secondary|Physician Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Functional Goal at Week 12|Physician assessment of success, as determined by percentage of patients who achieve their principal functional goal (i.e., a score of 0 to +2 inclusive on the goal attainment scale [GAS]) at week 12. The GAS is 6-point scale where -3 means function is worse than at start, 0 means the expected goal was attained, and +2 is much better function than expected.|Week 12|Intent-to-treat, which consists of all patients who were randomized (started study) and received a baseline injection.||Percentage of Patients|||Number
751209|NCT00549783|Primary|Physician Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Active Functional Goal at Week 24|Physician assessment of success, as determined by percentage of patients who achieve their principal active functional goal (i.e. a score of 0 to +2 inclusive on the goal attainment scale [GAS]) at week 24 (or 10 weeks post second injection). The GAS is a 6-point scale where -3 means function is worse than at start, 0 means the expected goal was attained, and +2 is much better function than expected.|Week 24|Intent-to-treat, which consists of all patients who were randomized (started study) and received a baseline injection.||Percentage of Patients|||Number
751210|NCT00549822|Secondary|Serum HER-2/Neu Levels and Serum/Plasma Angiogenic Mediators|Measurements for the serum HER-2/neu (human epidermal growth factor receptor 2) levels and serum/plasma angiogenic mediators|2 years|Study terminated prematurely due to slow accrual. Outcome measure data not available for analysis.|||||
751211|NCT00549822|Secondary|Median Time to Disease Progression With Intermittent Letrozole.|The median time to disease progression as determined by RECIST (Response Evaluation Criteria In Solid Tumors).|3 years|||Months||Full Range|Median
751212|NCT00549822|Primary|Number of Patients With Decline in Serum CA 15-3 (Carcinoma Antigen 15-3)|The Number of patients that have have a response of a decrease in CA 15-3 or CA 27.29 levels by at least 50% of that individual patient’s baseline or peak level after re-introducing Letrozole therapy following a break in therapy as described in the intervention.|3 years|||Participants|||Count of Participants
751213|NCT00549900|Primary|Number of Subjects Reporting Medically Significant Adverse Events|Medically significant AEs were defined as AEs prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. Common diseases include: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.|Throughout the study period (up to Month7)|||Subjects|||Number
751214|NCT00549900|Primary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Hematological Parameters|"Hematological and biochemical parameters assessed in blood samples include alanine aminotransferase (ALT), basophils, creatinine, eosinophils, hematocrit, lymphocytes, monocytes, neutrophils, platelets, red blood cell, and white blood cells.
Abnormalities reported include values outside the normal ranges: values higher than normal are designated as Above and values lower than normal as Below."|At Month 0 and Month 7|Analysis was performed on subjects from the Total vaccinated cohort that completed the study.||Subjects|||Number
751215|NCT00549900|Primary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|"An unsolicited adverse event is defined as any adverse event (AE) reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event."|Within 30 days (Day 0-29) after any vaccination|||Subjects|||Number
755241|NCT00593450|Secondary|Retinal Thickness Plus Subfoveal-fluid Thickness at Fovea||at 1 Year|||μm||Standard Deviation|Mean
751219|NCT00549939|Secondary|Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes|Symptomatic UTI episodes were assessed similar to the previous outcome measure but for a longer follow-up period.|52 weeks (double blind treatment period + open label extension treatment period)|The analysis was performed on the exposed population (i.e. all patients who received at least one dose of Alfuzosin regardless of the amount of treatment received). It included 3 + 3 patients treated during the 1st treatment period only, 26 + 28 patients treated during the 2nd treatment period only and 54 + 55 patients treated during both periods.||participants|||Number
751220|NCT00549939|Secondary|Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes|"When a patient presented with symptoms such as pain, fever or hematuria (discretion of the Investigator), an urinalysis was performed including a dipstick and a quantitative urine culture.
A symptomatic UTI was defined as the presence of symptoms and a positive culture with > 100 000 Colony Forming Units (CFUs) with a single organism."|12 weeks (double blind treatment period)|The analysis was performed on the intent-to-treat (ITT) population. All randomized patients were included in the analysis in the treatment group to which they were allocated as per randomization.||participants|||Number
751221|NCT00549939|Secondary|Relative Change in Detrusor Compliance|Relative change = 100 * (Detrusor compliance at 12 weeks - Detrusor compliance at baseline) / Detrusor compliance at baseline|12 weeks (double blind treatment period)|The analysis was performed on the same population as previously (i.e. ITT population excluding the patients who didn't have baseline and/or post-baseline value).||percentage of mL/cmH2O||Standard Error|Least Squares Mean
751222|NCT00549939|Secondary|Detrusor Compliance|"Detrusor compliance is defined as the relationship between change in detrusor volume and change in detrusor pressure.
It was calculated by dividing the volume change (ΔV) by the change in detrusor pressure (Δpdet) during that change in detrusor volume at leak point (C= ΔV/Δpdet)."|baseline and 12 weeks (double blind treatment period)|The analysis was performed on the intent-to-treat (ITT) population excluding the patients who didn't have baseline and/or post baseline detrusor compliance values. Patients were included in the treatment group to which they were allocated as per randomization.||mL/cmH20||Standard Deviation|Mean
751223|NCT00549939|Secondary|Relative Change in Detrusor LPP|Relative change = 100 * (Detrusor LPP at 12 weeks - Detrusor LPP at baseline) / Detrusor LPP at baseline|12 weeks (double blind treatment period)|The analysis was performed on the same population as previously (i.e. ITT population excluding the patients who didn't have baseline and/or post-baseline value).||percentage of cmH2O||Standard Error|Least Squares Mean
751224|NCT00549939|Secondary|Absolute Change in Detrusor LPP|Absolute change = Detrusor LPP at 12 weeks - Detrusor LPP at baseline|12 weeks ((double blind treatment period)|The analysis was performed on the same population as previously (i.e. ITT population excluding the patients who didn't have baseline and/or post-baseline value).||cmH2O||Standard Error|Least Squares Mean
751225|NCT00549939|Secondary|Detrusor Leak Point Pressure (LPP)|Detrusor Leak Point Pressure (LPP) was assessed at baseline and 12 weeks as described for the primary outcome measure.|baseline and 12 weeks (double blind treatment period)|The analysis was performed on the Intent-to-treat (ITT) population excluding the patients who didn't have baseline and/or post-baseline LPP values. Patients were included in the treatment group to which they were allocated as per randomization.||cmH2O||Standard Deviation|Mean
751226|NCT00549939|Primary|Number of Patients With Detrusor Leak Point Pressure (LPP) < 40 cm H2O|"Detrusor Leak Point Pressure (LPP) was measured by cystometry.
For each measure, 2 or 3 cystometries were carried out depending on the difference between the 2 first LPP values (if the difference ≥ 20 cm H2O, a 3rd cystometry was done). The lowest value was retained.
Investigators reading was then consolidated by the review of all cystometry data by 2 external Expert Reviewers, who were blinded for the study treatment.
The analysis was performed on consolidated investigators data (i.e. endorsed by the Investigator taking into account reviewers opinion)."|12 weeks (double blind treatment period)|The Intent-to-treat (ITT) population was used for the analysis. All randomized patients were included in the analysis in the treatment group to which they were allocated as per randomization.||participants|||Number
751227|NCT00550043|Secondary|Percentage of Subjects Who Achieved DAS 28 CRP Inactive Disease|Subjects who achieved inactive disease based on DAS 28 CRP (score <2.6). Subjects who achieved low disease activity were classified as responders in this analysis.|Day 28|mITT Population: subjects who were enrolled, took at least 1 dose of study drug, and had predose and at least 1 post baseline Rheumatoid arthritis (RA) assessments. Subjects who discontinued before the last scheduled efficacy evaluation had data imputed for time points after discontinuation; they had their last observation carried forward (LOCF).||Percentage of participants|||Number
751228|NCT00550043|Secondary|Percentage of Subjects Who Achieved DAS 28 ESR Inactive Disease|Subjects who achieved inactive disease based on the DAS 28 ESR (score <2.6). Subjects who achieved low disease activity were classified as responders in this analysis.|Day 28|mITT Population: subjects who were enrolled, took at least 1 dose of study drug, and had predose and at least 1 post baseline Rheumatoid arthritis (RA) assessments. Subjects who discontinued before the last scheduled efficacy evaluation had data imputed for time points after discontinuation; they had their last observation carried forward (LOCF).||Percentage of participants|||Number
751229|NCT00550043|Secondary|Percentage of Subjects Who Achieved DAS 28 CRP Low Disease|Subjects who achieved low disease activity based on the DAS 28 CRP (score <3.2). Subjects who achieved low disease activity were classified as responders in this analysis.|Day 28|mITT Population: subjects who were enrolled, took at least 1 dose of study drug, and had predose and at least 1 post baseline Rheumatoid arthritis (RA) assessments. Subjects who discontinued before the last scheduled efficacy evaluation had data imputed for time points after discontinuation; they had their last observation carried forward (LOCF).||Percentage of participants|||Number
751230|NCT00550043|Secondary|Percentage of Subjects Who Achieved DAS 28 ESR Low Disease|Subjects who achieved low disease activity based on the DAS 28 ESR (score <3.2). Subjects who achieved low disease activity were classified as responders in this analysis.|Day 28|mITT Population: subjects who were enrolled, took at least 1 dose of study drug, and had predose and at least 1 post baseline Rheumatoid arthritis (RA) assessments. Subjects who discontinued before the last scheduled efficacy evaluation had data imputed for time points after discontinuation; they had their last observation carried forward (LOCF).||Percentage of participants|||Number
751350|NCT00550537|Secondary|Pre-treatment Serum Proteomic Expression Pattern as a Predictor of Response to Erlotinib Hydrochloride and/or Carboplatin and Paclitaxel After Failing Treatment With Erlotinib Hydrochloride||End of treatment date|Lab data was lost by the collaborating institution, Colorado.|||||
751231|NCT00550043|Secondary|Change From Baseline in Disease Activity Score 28 (DAS 28) CRP Score|Calculation of the disease activity score 28 (DAS 28) score was based on the tender joint count, plus swollen joint count, plus PGA, plus C-reactive protein (CRP). A higher score indicated more disease activity. The mean change from baseline (which represent decreases in the DAS 28 CRP scores) are shown as positive numbers in these analyses. The DAS28 provides a score on a scale from 0 to 10 indicating the current activity of the rheumatoid arthritis (>5.1=high disease activity; <3.2=low disease activity; <2.6=remission).|Baseline, Day 28|mITT Population: subjects who were enrolled, took at least 1 dose of study drug, and had predose and at least 1 post baseline Rheumatoid arthritis (RA) assessments. Subjects who discontinued before the last scheduled efficacy evaluation had data imputed for time points after discontinuation; they had their last observation carried forward (LOCF).||Units on a scale||Standard Deviation|Mean
751232|NCT00550043|Secondary|Change From Baseline in Disease Activity Score 28 (DAS 28) ESR Score|Calculation of the disease activity score 28 (DAS 28) score was based on the tender joint count, plus swollen joint count, plus PGA, plus Erythrocyte sedimentation rate (ESR). The DAS28-ESR is expressed as units on a scale with the minimum score=0 (best) to maximum score=10 (worst). Remission was defined as DAS28-ESR <2.6. The mean change from baseline (which represent decreases in the DAS 28 ESR scores) are shown as positive numbers in these analyses.|Baseline, Day 28|mITT Population: subjects who were enrolled, took at least 1 dose of study drug, and had predose and at least 1 post baseline Rheumatoid arthritis (RA) assessments. Subjects who discontinued before the last scheduled efficacy evaluation had data imputed for time points after discontinuation; they had their last observation carried forward (LOCF).||Units on a scale||Standard Deviation|Mean
751233|NCT00550043|Secondary|The Percentage of Subjects Achieving ACR 70 Improvement|"The ACR 70 is defined as ≥ 70% improvement in tender joint count plus
≥ 70% improvement in swollen joint count plus ≥ 70% improvement in 3 of the following 5 criteria: subject’s assessment of pain, PGA, PHGA, subject’s self-assessed disability HAQ, and ESR or CRP, whichever shows the greatest change."|Day 28|mITT Population: subjects who were enrolled, took at least 1 dose of study drug, and had predose and at least 1 post baseline Rheumatoid arthritis (RA) assessments. Subjects who discontinued before the last scheduled efficacy evaluation had data imputed for time points after discontinuation; they had their last observation carried forward (LOCF).||Percentage of participants|||Number
751234|NCT00550043|Secondary|The Percentage of Subjects Achieving ACR 50 Improvement|The ACR 50 is defined as ≥ 50% improvement in tender joint count plus ≥ 50% improvement in swollen joint count plus ≥50% improvement in 3 of the following 5 criteria: subject’s assessment of pain, PGA, PHGA, subject’s self-assessed disability HAQ, and ESR or CRP, whichever shows the greatest change.|Day 28|mITT Population: subjects who were enrolled, took at least 1 dose of study drug, and had predose and at least 1 post baseline Rheumatoid arthritis (RA) assessments. Subjects who discontinued before the last scheduled efficacy evaluation had data imputed for time points after discontinuation; they had their last observation carried forward (LOCF).||Percentage of participants|||Number
751235|NCT00550043|Primary|The Percentage of Subjects Achieving American College of Rheumatology (ACR) 20 Improvement|The ACR 20 is defined as ≥ 20% improvement in tender joint count plus ≥ 20% improvement in swollen joint count plus ≥ 20% improvement in 3 of the following 5 criteria: subject’s assessment of pain, Subject’s global assessment of disease activity (PGA), Physician’s global assessment of disease activity (PHGA), subject’s self-assessed disability Health Assessment Questionnaire (HAQ), and Erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP), whichever shows the greatest change.|Day 28|modified intent-to-treat (mITT) Population: subjects enrolled, took 1 dose of study drug, had predose and at least 1 post baseline Rheumatoid arthritis (RA) assessments. Subjects discontinuing before the last scheduled efficacy evaluation had data imputed for time points after discontinuation; they had their last observation carried forward (LOCF).||Percentage of participants|||Number
751236|NCT00550147|Secondary|Attention Deficit/Hyperactivity Disorder Rating Scale -IV- Parent Version (ADHDRS-IV-Parent Version)|The Attention Deficit/Hyperactivity Disorder Rating Scale -IV- Parent Version (ADHDRS-IV-Parent:Inv) (Faries, Yalcin, Harder, & Heiligenstein, 2001) is an interviewer-administered semi structured interview with the parent, focusing on the 18 DSM-IV symptoms. Ratings are made on a 0 (never or rarely) to 3 (very often) scale. The range of the ADHDRS-IV is 0-54. A zero (0) scores indicates no ADHD symptoms and 54 indicates most severe ADHD symptoms. The ADHDRS-IV-Parent:Inv provides an overall severity score, symptom count, and ADHD diagnosis for the child.|See Arm/Group - repeated measures|Participants were those who qualified for the augmentation portion of the study (inadequate response to Oros MPH alone). Analysis was per protocol (intent-to-treat, LOCF).||units on a scale||Standard Deviation|Mean
751237|NCT00550147|Secondary|Swanson, Nolan and Pelham IV (SNAP-IV) Oppositional-Defiant Disorder Subscale|The Swanson, Nolan and Pelham (SNAP-IV) is a 90-item, parent-completed questionnaire consisting of symptoms of ADHD, aggression, depression, and mania. Parents rate each item from 0(not at all) to 3 (very much) based on their child's behavior during the past week. The scores from the Oppositional-Defiant Disorder section of this questionnaire will be used as secondary efficacy measures of parent-reported aggressive behavior. These scores range from 0-24.|See arm/group - repeated measures analysis|Participants were those who qualified for the augmentation portion of the study (inadequate response to Oros MPH alone). Analysis was per protocol (intent-to-treat, LOCF).||units on a scale||Standard Deviation|Mean
751238|NCT00550147|Secondary|Modified Overt Aggression Scale (MOAS)|"The Modified Overt Aggression Scale (MOAS) is a clinician-rated scale of aggressive outbursts experienced in the past week. Weightings are assigned for severity and frequency of aggression. MOAS total severity score will be completed as a secondary efficacy measure of aggressive behavior. The range for the MOAS is 0-235. A score of 0 indicates no aggression and a score of 235 indicates the most severe and frequent aggressive outbursts."|See arm/group - repeated measures|Participants were those who qualified for the augmentation portion of the study (inadequate response to Oros MPH alone). Analysis was per protocol (intent-to-treat, LOCF).||units on a scale||Standard Deviation|Mean
751239|NCT00550147|Secondary|CGI-S: Clinical Global Improvement Scale|"The CGI-S is a 1-7 investigator rating of overall severity of target behavioral symptoms, which will be completed at each visit as a secondary efficacy measure of global behavioral functioning. A score of 1 indicates normal, not ill at all and a score of 7 indicates among the most extremely ill patients."|See Arm/Group - Repeated Measures|Participants were those who qualified for the augmentation portion of the study (inadequate response to Oros MPH alone). Analysis was per protocol (intent-to-treat, LOCF).||units on a scale||Standard Deviation|Mean
751242|NCT00550173|Secondary|Number of Participants With Mutated or Non-Mutated Epidermal Growth Factor Receptor (EGFR) Genotype Status|EGFR mutation status was defined as: participants with any mutations detected were categorized as mutated and participants without any mutations detected were categorized as non-mutated.|Randomization to date of PD or death up to 38 months|A subset of the Q-ITT Population who had EGFR samples; Q-ITT Population: defined as all participants with nonsquamous histology, who were randomized to therapy.||participants|||Number
751243|NCT00550173|Secondary|Time to Worsening of Symptoms (TWS) on Lung Cancer Symptoms Scale (LCSS)|TWS assessed using the LCSS a participant rated lung cancer instrument which consisted of 9 disease related symptoms and quality of life (QoL) items, with 6 subscales related to major lung cancer symptoms (appetite, cough, fatigue, dyspnea, hemoptysis, and pain) and 3 summation items related to QoL (activity status, symptomatic distress, and overall QoL). Each item is marked on a visual analog scale (VAS) 0 (low symptoms/QoL items) to 100 (high symptoms/QoL items). The mean of the 6 subscales is used to calculate the average symptom burden index. TWS was measured from the date of study enrollment to the first date of a worsening in any 1 of the 6 LCSS symptom-specific items (as defined by a VAS 15-mm increase from baseline in the patient-reported score for any of these 6 items).|Randomization to first date of worsening of any of 6 LCSS symptom specific items or up to 12.4 months|A subset of the Q-ITT Population that included participants with LCSS results; Q-ITT Population: defined as all participants, with nonsquamous histology, who were randomized to therapy.||months||95% Confidence Interval|Median
751244|NCT00550173|Secondary|Percentage of Participants With CR, PR, and Stable Disease (SD) - Disease Control Rate (DCR)|DCR was defined as the percentage of participants with CR, PR, or SD divided by the number of randomized and treated participants as assessed using the RECIST criteria. CR was defined as the disappearance of all target lesions; PR was defined as 1) at least a 30% decrease in sum of longest diameter of target lesions or 2) complete disappearance of target lesions, with persistence (but not worsening) of 1 or more non-target lesions; PD was defined as at least a 20% increase in sum of longest diameter of target lesions; SD was defined as small changes that did not meet the above criteria.|Randomization to disease progression up to 38 months|Q-ITT-TA Population: defined as all participants, with nonsquamous histology, who were randomized to therapy and had measurable or evaluable lesions at baseline.||percentage of participants|||Number
751245|NCT00550173|Secondary|Number of Participants With Adverse Events|A summary of serious and all other non-serious adverse events (AEs), which include AEs reported for pharmacological toxicity, is located in the Reported Adverse Event module.|Randomization up to 39 months|Safety Population defined as non-squamous participants who received at least 1 dose of study therapy (pemetrexed plus erlotinib or pemetrexed or erlotinib). One participant was assigned to pemetrexed (single therapy) but received erlotinib (single therapy) at first cycle and this lead to the discrepancy of participants for the safety analysis.||participants|||Number
751246|NCT00550173|Secondary|Overall Survival (OS)|OS is defined as the time from randomization to the date of death from any cause.|Baseline to date of death from any cause up to 45.5 months|Q-ITT Population: defined as all participants with nonsquamous histology, who were randomized to therapy. Survival time was censored at the date of last contact for participants who were still alive or lost to follow-up, number of participants censored 35 (pemetrexed plus erlotinib), 44 (erlotinib) and 31 (pemetrexed).||months||95% Confidence Interval|Median
751247|NCT00550173|Secondary|Percentage of Participants With a Tumor Response of Complete Response (CR) or Partial Response (PR) [Tumor Response Rate (TRR)]|TRR was defined as the number of responders (complete or partial) divided by the number of participants qualified for tumor response, as assessed using the RECIST version 1.0 guideline, multiplied by 100. RECIST guidelines: CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm) and normalization of tumor marker level of non-target lesions; PR was defined as at least a 30% decrease in sum of longest diameter of target lesions.|Randomization to measured disease progression up to 38 months|Q-ITT Population - Tumor Analyzable (Q-ITT-TA) Population: defined as all participants with nonsquamous histology, who were randomized to therapy and had measurable or evaluable lesions at baseline.||percentage of participants|||Number
751248|NCT00550173|Primary|Progression-Free Survival (PFS)|PFS is defined as the time from randomization to the first date of progressive disease (PD; either objectively determined or clinical progression) or death from any cause. PD was defined as at least a 20% increase in sum of longest diameter of target lesions as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 guidelines. Time to disease progression was censored at the date of death.|Randomization to measured PD up to 38 months|Qualified Intent to Treat (Q-ITT) Population defined as all participants with nonsquamous histology, who were randomized to therapy.||months||95% Confidence Interval|Median
751249|NCT00550277|Secondary|Overall Response||18 months||||||
751250|NCT00550277|Secondary|To Evaluate the Toxicity of LBH589 in Patients With Refractory Advanced Clear Cell Renal Carcinoma||18 months||||||
751251|NCT00550277|Primary|To Evaluate the Efficacy of LBH589 in the Treatment of Patients With Refractory Clear Cell Carcinoma, as Measured by Progression-free Survival||18 months|||months||95% Confidence Interval|Median
751252|NCT00550368|Secondary|Intensity of Gastrointestinal Symptoms|Composite gastrointestinal symptom score was on a scale from 0 (no symptoms) to 15 (severe symptoms). This composite was the sum of 5 self-reported, symptom scores, each ranging from 0 (none) to 3 (severe). The self-reported symptoms that subjects scored were: malaise, headache, nausea, vomiting, and loose stool.|48 hours|||units on a scale||Full Range|Median
751253|NCT00550368|Primary|Development of Diarrhea||48 hours|||participants|||Number
751254|NCT00550394|Primary|Percent Heavy Drinking Days|Change in percent heavy drinking days (number of days of > 4 drinks/day divided by number of days in that study period).|baseline to 12 weeks or endpoint (up to 11 weeks)|||Percent heavy drinking days||Standard Deviation|Mean
751255|NCT00550394|Primary|Percentage of Days Abstinent|Change in percent days abstinent (the number of non-drinking days divided by the number of days in that study period).|baseline to 12 weeks or endpoint (up to 11 weeks)|||Percentage of days abstinent||Standard Deviation|Mean
751256|NCT00550394|Primary|Drinks Per Drinking Day|Change in drinks/drinking day (number of drinks consumed divided by the number of days during which alcohol was consumed during that study period)|baseline to 12 weeks or endpoint (up to 11 weeks)|||Drinks per drinking day||Standard Deviation|Mean
755242|NCT00593450|Secondary|Total Thickness Change From Baseline at Fovea||Baseline and 1 Year|||μm||Standard Deviation|Mean
751258|NCT00550407|Post-Hoc|Number of Participants With Intervention for a Manic, Hypomanic, or Mixed Episode|The number of participants with intervention for a manic, hypomanic, or mixed episode was measured. The necessity of the intervention was determined by the Investigator’s discretion. This outcome measure was added post-hoc because no data are being reported for the Placebo or Lamotrigine groups regarding time to intervention for manic, hypomanic, or mixed episode (TIMan). Data from participants who had not met TIMan were defined as censored.|Randomization to Study Withdrawal (up to Week 26)|FAS2||participants|||Number
751259|NCT00550407|Post-Hoc|Number of Participants With Intervention for Depressive Episode|The number of participants with intervention for depressive episode was measured. The necessity of the intervention was determined by the Investigator’s discretion. This outcome measure was added post-hoc because no data are being reported for the Placebo or Lamotrigine groups regarding time to intervention for depressive episode (TIDep). Data from participants who had not met TIDep were defined as censored.|Randomization to Study Withdrawal (up to Week 26)|FAS2||participants|||Number
751260|NCT00550407|Post-Hoc|Number of Participants With Intervention for Any Mood Episode|The number of participants with intervention for any mood episode was measured. The necessity of the intervention was determined by the Investigator’s discretion. This outcome measure was added post-hoc because no data are being reported for the Lamotrigine group regarding time to intervention for any mood episode (TIME). See the outcome measure for TIME for data for the Placebo group. Data from participants who had not met TIME were defined as censored.|Randomization to Study Withdrawal (up to Week 26)|FAS2||participants|||Number
751261|NCT00550407|Post-Hoc|Number of Participants With a Withdrawal Event|The number of participants who withdrew from the study was measured. This outcome measure was added post-hoc because no data are being reported for the Lamotrigine group regarding time to study withdrawal. See the primary outcome measure for time to study withdrawal data for the Placebo group. Data from participants who had not withdrawn were defined as censored.|Randomization to Study Withdrawal (up to Week 26)|FAS2||participants|||Number
751262|NCT00550407|Secondary|Change From Baseline in Young Mania Rating Scale (YMRS) Total Scores at Week 16/Withdrawal (Preliminary Phase)|The YMRS is an 11-item questionnaire that detects change and measures illness severity. Individual items are rated on a scale of 0-8 and 0-4, with the total YMRS score ranging from 0 (not ill) to 60 (severely ill). Change from baseline was calculated as the Week 16/Withdrawal value minus the baseline value (at Week 0 of the Preliminary Phase).|Baseline and Week 16/Withdrawal|FAS1. Nine participants in the Lamotrigine 25-200 mg group have no data for the HAMD-17 at Week 16/Withdrawal.||points on a scale||Standard Deviation|Mean
751263|NCT00550407|Secondary|Change From Baseline in Young Mania Rating Scale (YMRS) Total Scores at Week 26/Withdrawal (Randomized Phase)|The YMRS is an 11-item questionnaire that detects change and measures illness severity. Individual items are rated on a scale of 0-8 and 0-4, with the total YMRS score ranging from 0 (not ill) to 60 (severely ill). Change from baseline was calculated as the Week 26/Withdrawal value minus the baseline value (at the time of randomization).|Baseline and Week 26/Withdrawal|FAS2||points on a scale||Standard Deviation|Mean
751264|NCT00550407|Secondary|Change From Baseline in Hamilton Rating Scale for Depression (HAMD-17) Scores at Week 16/Withdrawal (Preliminary Phase)|The HAMD-17 is a 17-item questionnaire that detects change and measures illness severity. Individual items are rated on a scale of 0-4, and 0-2, with the total HAMD-17 score ranging from 0 (not ill) to 52 (severely ill). Change from baseline was calculated as the Week 16/Withdrawal value minus the baseline value (at Week 0 of the Preliminary Phase).|Baseline and Week 16/Withdrawal|FAS1. Nine participants in the Lamotrigine 25-200 mg group have no data for the HAMD-17 at Week 16/Withdrawal.||points on a scale||Standard Deviation|Mean
751265|NCT00550407|Secondary|Change From Baseline in Hamilton Rating Scale for Depression (HAMD-17) Scores at Week 26/Withdrawal (Randomized Phase)|The HAMD-17 is a 17-item questionnaire that detects change and measures illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with the total HAMD-17 score ranging from 0 (not ill) to 52 (severely ill). Change from baseline was calculated as the Week 26/Withdrawal value minus the baseline value (at the time of randomization).|Baseline and Week 26/Withdrawal|FAS2||points on a scale||Standard Deviation|Mean
751266|NCT00550407|Secondary|Change From Baseline in Clinical Global Impressions of Severity (CGI-S) Scores at Week 16/Withdrawal (Preliminary Phase)|The CGI-S is a 7-point scale that assessed the participant's severity of illness based on the total clinical experience of the Investigator with this particular population; 0=not assessed, 1= normal, not at all ill to 7= among the most extremely ill participants. Change from baseline was calculated as the Week 16/Withdrawal value minus the baseline value (at Week 0 of the Preliminary Phase).|Baseline and Week 16/Withdrawal|FAS1. Nine participants in the Lamotrigine 25-200 mg group have no data for the CGI-S at Week 16/Withdrawal.||points on a scale||Standard Deviation|Mean
751267|NCT00550407|Secondary|Change From Baseline in Clinical Global Impressions of Severity (CGI-S) Scores at Week 26/Withdrawal (Randomized Phase)|The CGI-S is a 7-point scale that assessed the participant's severity of illness based on the total clinical experience of the Investigator with this particular population; 0=not assessed, 1= normal, not at all ill to 7= among the most extremely ill participants. Change from baseline was calculated as the Week 26/Withdrawal value minus the baseline value (at the time of randomization).|Baseline and Week 26/Withdrawal|FAS2||points on a scale||Standard Deviation|Mean
751268|NCT00550407|Secondary|Clinical Global Impressions of Improvement (CGI-I) at Week 16/Withdrawal (Preliminary Phase)|The CGI-I is a 7-point scale that assessed the participant's global improvement compared to his/her condition at study entry whether or not, in the judgement of the Investigator, it was due entirely to drug treatment; 0=not assessed, 1= very much improved to 7= very much worse.|Week 16/Withdrawal|Full Analysis Set in the Preliminary Phase (FAS1): all participants who received at least one dose of study medication for the Preliminary Phase and underwent at least one efficacy assessment after receiving the study medication in the Preliminary Phase. Nine participants in the Lamotrigine 25-200 mg group have no data for the CGI-I.||points on a scale||Standard Deviation|Mean
751269|NCT00550407|Secondary|Clinical Global Impressions of Improvement (CGI-I) at Week 26/Withdrawal (Randomized Phase)|The CGI-I is a 7-point scale that assessed the participant's global improvement compared to his/her condition at study entry whether or not, in the judgement of the Investigator, it was due entirely to drug treatment; 0=not assessed, 1= very much improved to 7= very much worse.|Week 26/Withdrawal|FAS2||points on a scale||Standard Deviation|Mean
751351|NCT00550537|Primary|Pre-treatment Tumor Proteomic Profile as a Predictor of Response, Stable Disease, or Progressive Disease||End of treatment date|Lab data was lost by the collaborating institution, Colorado.|||||
751270|NCT00550407|Secondary|Time to Intervention for Manic, Hypomanic, or Mixed Episode (TIMan)|"The TIMan was defined as the time from entry into the Randomized Phase to the time of the first prescription of any additional pharmacotherapy or ECT determined by the Investigator to be necessary for treatment of the relapse or recurrence of a manic, hypomanic, or mixed episode. No data are being presented for either treatment group. See the outcome measure entitled Number of Participants with Intervention for a Manic, Hypomanic, or Mixed Episode for data related to TIMan."|Randomization to Study Withdrawal (up to Week 26)|FAS2. In both groups, the estimated median TIMan was not calculable because the probability of not reaching TIMan remained greater than 0.50 throughout the study.|||||
751271|NCT00550407|Secondary|Time to Intervention for Depressive Episode (TIDep)|"The TIDep was defined as the time from entry into the Randomized Phase to the time of the first prescription of any additional pharmacotherapy or ECT determined by the Investigator to be necessary for treatment of a relapse or recurrence of depression episode. No data are being presented for either treatment group. See the outcome measure entitled Number of Participants with Intervention for Depressive Episode for data related to TIDep."|Randomization to Study Withdrawal (up to Week 26)|FAS2. In the Lamotrigine 200 mg group, the estimated median TIDep was not calculable because the probability of not reaching TIDep remained greater than 0.50 throughout the study. The upper limit of the confidence interval was not calculable for the Placebo group due to an insufficient number of events.|||||
751272|NCT00550407|Secondary|Time to Intervention for Any Mood Episode (TIME)|"The TIME was defined as the time from entry into the Randomized Phase to the time of the first prescription of any additional pharmacotherapy or electroconvulsive therapy (ECT) determined by the Investigator to be necessary for treatment of a relapse or recurrence of depression or the recurrence of a manic, hypomanic, or mixed episode, whichever occurred first. Categorization as a manic, hypomanic, or mixed episode was left to the Investigator's discretion. See the outcome measure entitled Number of Participants with Intervention for Any Mood Episode for data related to TIME."|Randomization to Study Withdrawal (up to Week 26)|FAS2. In the Lamotrigine 200 mg group, the estimated median TIME was not calculable because the probability of not reaching TIME remained greater than 0.50 throughout the study.||days||95% Confidence Interval|Median
751273|NCT00550407|Primary|Time to Withdrawal From Study|"The time from randomization to the time at which the participant was withdrawn from the Double-Blind Phase of the study for any reason was measured. No data are reported for the Lamotrigine group because of an incalculable confidence interval. See the outcome measure entitled Number of Participants with a Withdrawal Event for data regarding the number of participants who withdrew from the study."|Randomization to Study Withdrawal (up to Week 26)|Full Analysis Set in Randomized (double-blind) Phase (FAS2): participants who received at least one dose of study medication in the Randomized Phase (RP) and had at least one post-treatment efficacy assessment in the RP. The upper limit of the confidence interval was not calculable for the Lamotrigine group due to an insufficient number of events.||days||95% Confidence Interval|Median
751274|NCT00550446|Other Pre-specified|Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Week 2, 12 and 24/ET|FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.|Baseline, Week 2, 12, 24/ ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
751275|NCT00550446|Other Pre-specified|Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale|FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.|Baseline, Week 2, 12, 24/ ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
751276|NCT00550446|Other Pre-specified|Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET|Participant-rated questionnaire to assess key constructs of sleep over the past week. Consists of a 12-item based on 7 subscales: sleep disturbance (SD), snoring (Sno), awakened short of breath (A SOB) or with headache, sleep adequacy (Ade), and somnolence (Som) (range: 0-100); sleep quantity (Qua) (range: 0-24), and optimal (Opt) sleep (yes: 1, no: 0) and 9 item index measures of sleep disturbance were constructed to provide 2 composite scores: sleep problem summary (SPS) and overall sleep problems (OSP). Except sleep adequacy, optimal sleep and quantity, higher scores=greater impairment. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range*100); total score range: 0 to 100; higher score = greater intensity of attribute.|Baseline, Week 2, 12, 24/ ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
751379|NCT00550732|Secondary|Overall Survival at 3 Months|Total number of participant survivors was assessed at 3 months.|3 months|All enrolled participants||Percentage of Participants|||Number
755243|NCT00593450|Secondary|Total Thickness at Fovea||at 1 Year|||μm||Standard Deviation|Mean
751277|NCT00550446|Other Pre-specified|Medical Outcome Study- Sleep Scale (MOS-SS)|Participant-rated questionnaire to assess key constructs of sleep over the past week. Consists of a 12-item based on 7 sub scales: sleep disturbance (SD), snoring (Sno), awakened short of breath (ASOB) or with headache, sleep adequacy (Ade), and somnolence (Som) (range:0-100); sleep quantity (Qua)(range:0-24), and optimal (Opt) sleep (yes: 1, no: 0)and nine item index measures of sleep disturbance were constructed to provide composite scores: sleep problem summary (SPS) and overall sleep problems (OSP). Except sleep adequacy, optimal sleep and quantity, higher scores=greater impairment. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute.|Baseline, Week 2, 12, 24/ ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
751278|NCT00550446|Other Pre-specified|Change From Baseline in Fluorescence Activated Cell Sorting (FACS) Lymphocyte Biomarkers at Week 24|The following biomarkers were assessed: CD3, CD4, CD8, CD19 and CD56. FACS analysis for lymphocyte subset markers were used to assess the effects of repeated doses of CP-690,550.|Baseline, Week 24/ ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||cells/mcL||Standard Deviation|Mean
751279|NCT00550446|Other Pre-specified|Fluorescence Activated Cell Sorting (FACS) Lymphocyte Biomarkers|The following biomarkers were assessed: Cluster of Differentiation 3 (CD3), CD4, CD8, CD19 and CD56. FACS analysis for lymphocyte subset markers were used to assess the effects of repeated doses of CP-690,550.|Baseline, Week 24/ ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||cells per micro liter (cells/mcL)||Standard Deviation|Mean
751280|NCT00550446|Other Pre-specified|Change From Baseline in Serum Immunoglobulin G (IgG), Immunoglobulin M (IgM) and Immunoglobulin A (IgA) Levels at Week 24|Blood samples for immunoglobulin assessments were obtained to determine change from baseline in serum IgG, IgM, and IgA levels.|Baseline, Week 24/ ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||mg/dL||Standard Deviation|Mean
751281|NCT00550446|Other Pre-specified|Serum Immunoglobulin G (IgG), Immunoglobulin M (IgM) and Immunoglobulin A (IgA) Levels|Blood samples for immunoglobulin assessments were obtained to determine IgG, IgM, and IgA levels in serum.|Baseline, Week 24/ ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||milligram per deciliter (mg/dL)||Standard Deviation|Mean
751282|NCT00550446|Secondary|Change From Baseline in Euro Quality of Life 5 Dimension (EQ-5D)- Health State Profile Utility Score at Week 12 and 24/ET|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Baseline, Week 12, 24/ ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
751283|NCT00550446|Secondary|Euro Quality of Life 5 Dimension (EQ-5D)-Health State Profile Utility Score|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Week 12, 24/ ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
751284|NCT00550446|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24/ET|SF-36 is a standardized survey evaluating 8 domains (of 2 components [C]; physical [Ph] and mental [Mn]) of functional health and well being: physical and social (So) functioning (Fn), physical and emotional role (role-physical [R-P], role-emotional [R-E]) limitations, bodily pain (BP), general health (GH), vitality (Vit), mental health (MnH). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline, Week 12, 24/ ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
755244|NCT00593450|Secondary|Average Cost of Drug/Patient||at 1 Year|||US dollars per patient||Standard Deviation|Mean
751285|NCT00550446|Secondary|36-Item Short-Form Health Survey (SF-36)|SF-36 is a standardized survey evaluating 8 domains (of 2 components [C]; physical [Ph] and mental [Mn]) of functional health and well being: physical and social (So) functioning (Fn), physical and emotional role (role-physical [R-P], role-emotional [R-E]) limitations, bodily pain (BP), general health (GH), vitality (Vit), mental health (MnH). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline, Week 12, 24/ ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
751286|NCT00550446|Secondary|Percentage of Participants With Disease Remission Based on DAS28-3 (CRP)|DAS28-3 (CRP) defined remission was classified as a score of <2.6.|Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||percentage of participants|||Number
751287|NCT00550446|Secondary|Percentage of Participants With Disease Remission Based on Normal C-reactive Protein (CRP)|CRP value less than or equal to upper limit of normal (ULN) implied disease remission (ULN=4.9 mg/L).|Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||percentage of participants|||Number
751288|NCT00550446|Secondary|Percentage of Participants With Disease Improvement Based on DAS28-4 (ESR)|Disease improvement was classified as good, moderate, and none based on improvement in DAS28-4 (ESR) from baseline and present DAS28-4 (ESR) score. Good: an improvement from baseline of >1.2 and a present score of <=3.2; none: an improvement of <=0.6 or >0.6 to <=1.2 with a present score of >5.1; remaining participants were classified as having moderate (Mod) improvement. Scores of good and moderate were considered to have therapeutic response.|Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||percentage of participants|||Number
751289|NCT00550446|Secondary|Change From Baseline in Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET|DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR [mm/hour] and PtGA of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) <= 3.2 implies low disease activity and > 3.2 to 5.1 implies moderate to high disease activity, and < 2.6 = remission.|Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
751290|NCT00550446|Secondary|Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])|DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and PtGA of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) <= 3.2 implies low disease activity and > 3.2 to 5.1 implies moderate to high disease activity, and < 2.6 = remission.|Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
751291|NCT00550446|Secondary|Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET|DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) <= 3.2 implied low disease activity and > 3.2 to 5.1 implied moderate to high disease activity, and < 2.6 = remission.|Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
751292|NCT00550446|Secondary|Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])|DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) less than or equal to (<=) 3.2 implied low disease activity and greater than (>) 3.2 to 5.1 implied moderate to high disease activity, and less than (<) 2.6 = remission.|Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
751406|NCT00556478|Secondary|Subject Premature Ejaculation Profile (PEP) at Month 2|Scores for perceived control over ejaculation, personal distress related to ejaculation, satisfaction with sexual intercourse and interpersonal difficulty related to ejaculation based on the subject PEP at month 2. Proportion of subjects with at least a 1 point category improvement in subject PEP domain scores from baseline to month 2.|2 months|ITT||percentage of participants|||Number
751293|NCT00550446|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
751294|NCT00550446|Secondary|Health Assessment Questionnaire-Disability Index (HAQ-DI)|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
751295|NCT00550446|Secondary|Change From Baseline in C-reactive Protein (CRP) at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is 0 mg/L to 10 mg/L. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||mg/L||Standard Deviation|Mean
751296|NCT00550446|Secondary|C-Reactive Protein (CRP)|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is 0 milligram per liter (mg/L) to 10 mg/L. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||mg/L||Standard Deviation|Mean
751297|NCT00550446|Secondary|Change From Baseline in Physician's Global Assessment (PGA) of Arthritis Pain at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET|Physician global assessment of arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.|Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||mm||Standard Deviation|Mean
751298|NCT00550446|Secondary|Physician Global Assessment (PGA) of Arthritis|Physician global assessment of arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.|Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||mm||Standard Deviation|Mean
751299|NCT00550446|Secondary|Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly."|Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||mm||Standard Deviation|Mean
751300|NCT00550446|Secondary|Patient Global Assessment (PtGA) of Arthritis Pain|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly."|Baseline, 2, 4, 6, 8, 10, 12, 16, 20, 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. n=number of participants evaluable at specific time points for each arm group, respectively.||mm||Standard Deviation|Mean
751301|NCT00550446|Secondary|Change From Baseline in Patient Assessment of Arthritis Pain at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET|Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.|Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||mm||Standard Deviation|Mean
751302|NCT00550446|Secondary|Patient Assessment of Arthritis Pain|Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.|Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. n=number of participants evaluable at specific time points for each arm group, respectively.||mm||Standard Deviation|Mean
755245|NCT00593450|Secondary|Number of Treatments|Cumulative over the 1 year of trial|1 Year|||Number of Treatments||Standard Error|Mean
751303|NCT00550446|Secondary|Change From Baseline in Swollen Joint Count at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24|Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling = 1. A negative value in change from baseline indicated an improvement.|Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||swollen joints||Standard Deviation|Mean
751304|NCT00550446|Secondary|Swollen Joint Counts (SJC)|Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1.|Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. n=number of participants evaluable at specific time points for each arm group, respectively.||swollen joints||Standard Deviation|Mean
751305|NCT00550446|Secondary|Change From Baseline in Tender Joint Count at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24 or ET|Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1. A negative value in change from baseline indicated an improvement.|Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||tender joints||Standard Deviation|Mean
751306|NCT00550446|Secondary|Tender Joint Count (TJC)|Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.|Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. n=number of participants evaluable at specific time points for each arm group, respectively.||tender joints||Standard Deviation|Mean
751307|NCT00550446|Secondary|Area Under the Numeric Index of American College of Rheumatology Response (ACR-n) Curve|ACR-n = calculated for each participant by taking the lowest percentage improvement in (1) SJC or (2) TJC or (3) the median of the remaining 5 components of the ACR response (participant's assessment of disease activity; participant's global assessment of pain; physician's assessment of disease activity; participant's assessment of physical function; an acute phase reactant value - CRP). Negative numbers indicate worsening. Area under the curve (AUC) for ACR-n is the measure of the area under the curve of the mean change from baseline in ACR-n. The trapezoidal rule was used to compute the AUC.|Baseline up to Week 2, 4, 6, 8, 10, 12|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. Missing values were imputed using Last Observation Carried Forward (LOCF).||units on a scale||Standard Deviation|Mean
751308|NCT00550446|Secondary|Percentage of Participants Achieving American College of Rheumatology 90% (ACR90) Response|ACR90 response: >= 90% improvement in TJC or SJC and 90% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Missing values were imputed using BOCF. n=number of participants evaluable at specific time points for each arm group respectively.||percentage of participants|||Number
751309|NCT00550446|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response|ACR70 response: >= 70% improvement in TJC or SJC and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Missing values were imputed using BOCF. n=number of participants evaluable at specific time points for each arm group respectively.||percentage of participants|||Number
751310|NCT00550446|Secondary|Percentage of Participants Achieving American College of Rheumatology 50%(ACR50) Response|ACR50 response: >= 50% improvement in TJC or SJC and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Missing values were imputed using BOCF. n=number of participants evaluable at specific time points for each arm group, respectively.||percentage of participants|||Number
751311|NCT00550446|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response|ACR20 response: 20% improvement in TJC; >=20% improvement in SJC; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 2, 4, 6, 8, 10, 16, 20 and 24/Early Termination (ET)|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Missing values were imputed using BOCF. n=number of participants evaluable at specific time points for each arm group, respectively.||percentage of participants|||Number
751348|NCT00550537|Secondary|Analysis of Individual and Pattern(s) of Erlotinib Hydrochloride-induced Genomic and Proteomic Biomarker Changes in Relation to Response or Non-response to Treatment|End of treatment date|End of treatment date|Lab data was lost by the collaborating institution, Colorado.|||||
757497|NCT00608491|Secondary|Change in Blood Sodium Level||Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mEq/L||Standard Deviation|Mean
751312|NCT00550446|Primary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12|ACR20 response: greater than or equal to (>=) 20 % improvement in tender joint count (TJC); >= 20% improvement in swollen joint count (SJC); and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Week 12|Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. The analysis used Baseline Observation Carried Forward (BOCF) imputation for missing values.||percentage of participants|||Number
751349|NCT00550537|Secondary|Tumor Proteomic Profiles as Predictors of Response to Carboplatin and Paclitaxel After Failing Treatment With Erlotinib Hydrochloride||End of treatment date|Lab data was lost by the collaborating institution, Colorado.|||||
751342|NCT00550537|Secondary|Overall Survival for Erlotinib Initial Therapy in Chemotherapy-naïve Patients With Advanced NSCLC|The overall survival time is defined as the time from on treatment to death. Patients were censored of they were alive at the last follow up date. The median survival time and its confidence interval were estimated using Kaplan-meier method.|Through study completion, an average of 1 year|Total 116 participants. One patient was excluded due to death before any treatment.||months||95% Confidence Interval|Median
751343|NCT00550537|Secondary|Number of Patients With Worst-grade Toxicities Per Grade|"The intensity of the AE will be graded according to the Common Toxicity Criteria (CTC) of the (US) National Cancer Institute (NCI) – Cancer Therapy Evaluation Program (CTEP) [version 3.0 of December 2003] (Appendix B).
Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE"|Through study completion, an average of 1 year|116 paticipants, one patient was excluded due to death before any treatment. All patients who received erlotinib treatment and experienced an Adverse events.||participants|||Number
751344|NCT00550537|Secondary|Progression-free Survival (PFS) for Erlotinib Initial Therapy in Chemotherapy-naïve Patients With Advanced NSCLC|PFS is defined as the time from on erlotinib treatment date to progression or death (whichever comes first) before cross-over to PC or PC+B. For those did not progressed nor died, they were censored at the last follow up (either the off erlotinib treatment date or lost follow up date). The median survival time and 95% confidence interval were estimated using Kaplan-meier method.|Through study completion, an average of 1 year|Total 116 participants. One patient was excluded due to death before erlotinib treatment. Total 115 patients were included in the analysis.||months||95% Confidence Interval|Median
751345|NCT00550537|Secondary|Response Rate for Erlotinib Initial Therapy in Chemotherapy-naïve Patients With Advanced NSCLC|Number of patients in each response category, per RECIST v1.1, summarized as follows for target lesion criteria (see RECIST v1.1 for additional details): complete response (CR),disappearance of target lesions; partial response (PR), >=30% decrease in sum of longest diameter of target lesions; progressive disease (PD), >=20% increase in sum of LD of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or SD. The response rate is calculated as the percentage of PR+CR among patients assessed for response.|Through study completion, an average of 1 year|Total 116 participants, 11 not assessed and 4 not evaluable. 101 assessed for response.||percentage of patients assessed||95% Confidence Interval|Mean
751346|NCT00550537|Secondary|Determination of a Set of Biomarkers to be Evaluated in Tumor Tissue or Surrogate Tissues Prior to Treatment With Erlotinib Hydrochloride to Enable Patient Selection for Therapy||End of treatment date|Lab data was lost by the collaborating institution, Colorado.|||||
751347|NCT00550537|Secondary|Correlation of the Efficacy and Toxicity of Erlotinib Hydrochloride With Expression of EGFR, EGFR Pathway, ErbB Family, and Other Related Biomarkers||End of treatment date|Lab data was lost by the collaborating institution, Colorado.|||||
751352|NCT00550550|Secondary|Participant Average Weekly Rhinoconjunctivitis Quality-of-Life Questionnaire (RQLQ) Total Score Over the Entire GPS|The RQLQ has 28 questions and focusses on 7 domains that may be significantly impaired in participants with seasonal allergic rhinoconjunctivitis: sleep impairment, non-nasal symptoms, practical problems, nasal symptoms, eye symptoms, activity limitations, and emotional difficulty. The RQLQ score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains. RQLQ scores range from 0 (best) to 6 (worst), with a higher score indicating more significant impairment.|Start of the GPS to the End of the GPS|The FAS population was comprised of all participants randomized with at least one post-treatment diary data entry for the rhinoconjunctivitis quality-of-life measure.||Units on a Scale||Standard Error|Mean
751353|NCT00550550|Secondary|Participant Average Rhinoconjunctivitis Daily Medication Score (DMS) Over the Entire GPS|The DMS is composed of a sum of the scores associated with rescue medication use per day. Rescue medications were implemented when a participant had a symptom score >= 4. Rescue medications for allergic rhinoconjunctivitis were to be utilized in a step-wise fashion: loratadine, olopatadine hydrochloride 0.1% opthalmic solution, mometasone, and prednisone, in that sequence. The score for the DMS ranged from 0 (no use of rescue medication) to 36 (maximum use of rescue medication). A lower medication score indicated less impact on symptoms and was suggestive of less use of rescue medication.|Start of the GPS to the End of the GPS|The FAS population was comprised of all participants randomized with at least one post-treatment diary data entry.||Units on a Scale||Standard Error|Mean
751354|NCT00550550|Secondary|Participant Average Rhinoconjunctivitis Daily Symptom Scores (DSS) Over the Entire GPS|The DSS is composed of six rhinoconjunctivitis symptoms which were recorded daily including runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy, and watery eyes, and the symptoms were measured on a scale of 0 (no symptom) to 3 (severe symptoms). A higher score indicated a higher level of symptoms and the total daily score could range from 0 (best) to 18 (worst).|Start of the GPS to the End of the GPS|The FAS population was comprised of all participants with at least one post-treatment diary data entry.||Units on a Scale||Standard Error|Mean
751355|NCT00550550|Primary|Participant Total Combined Symptom (TCS) Score Over the Entire Grass Pollen Season (GPS)|The TCS is the sum of the rhinoconjunctivitis daily symptom score (DSS) and rhinoconjunctivitis daily medication score (DMS) averaged over the entire GPS. The TCS ranged from 0 (no symptoms and no rescue medication use) to 54 (most severe symptoms and maximum use of rescue medication), with increasing score indicating a higher level of symptom severity. The DSS is composed of 6 rhinoconjunctivitis symptoms with scores from 0 (best) to 18 (worst), with increasing score indicating increased severity. The DMS is composed of a sum of the scores associated with rescue medication use per day. The range for the DMS was 0 (no rescue medication use) to 36 (maximum use of rescue medication), with a lower score indicating less use of rescue medication.|From the Start of the GPS to the End of the GPS|The Full Analysis Set (FAS) population was comprised of all participants randomized with at least one post-treatment diary data entry.||Units on a Scale||Standard Error|Mean
751364|NCT00550654|Secondary|Tumor Doubling Times During Systemic Treatment Compared Between Tumors Untreated With Radiation (Newly Developed Tumors) and Tumors Which Have Received Radiation Therapy|Rate of growth of the composite (total) treated volume (up to four sites) compared to the composite volume of up to four newly identified and untreated prospectively-identified (at the time of systemic progression) metastatic sites. Volume doubling time will be calculated assuming an exponential growth pattern.|Baseline and prior to termination of systemic therapy or protocol withdrawal|No data/specimens were collected. Study was terminated due to poor accrual.|||||
751365|NCT00550654|Secondary|Pain at Sites of Metastases|Improvement in pain from baseline will be assessed by the Brief Inventory for Pain criteria.|One and three months of follow up|No data/specimens were collected. Study was terminated due to poor accrual.|||||
751366|NCT00550654|Secondary|Interfraction and Intrafraction Motion With Megavoltage Computed Tomography (CT) Based on Sites of Metastasis|Megavoltage localization scans will be obtained and the physician and therapist will evaluate the cone beam image and compare this image to the expected image based on the patient's initial planning CT scan.|One to three months of followup|No data/specimens were collected. Study was terminated due to poor accrual.|||||
751408|NCT00556478|Secondary|Subject PEP at Month 1|Scores for perceived control over ejaculation, personal distress related to ejaculation, satisfaction with sexual intercourse and interpersonal difficulty related to ejaculation based on the subject PEP at month 1. Percentage of subjects with at least a 1 point category improvement in subject PEP domain scores at month 1.|1 month|ITT||percentage of participants|||Number
751367|NCT00550654|Secondary|12 Month Local Control in All Sites of Treatment, and at Each Site of Treatment|Local control (e.g. absence of local progression) is defined as Complete response (CR), partial response (PR) or stable disease (SD) of the treated site(s). Complete response is the disappearance of the target lesion. Partial response is a >/= 50% decrease in maximal dimension compared to pretreatment imaging. Stable disease does not qualify for CR, PR, or progression. Progression is an interval increase in the maximal dimension of the target lesion.|12 months|No data/specimens were collected. Study was terminated due to poor accrual.|||||
751368|NCT00550654|Secondary|Median Time to Local Progression|Interval from initiation of treatment on protocol to symptomatic or radiographic progression.|6-12 months|No data/specimens were collected. Study was terminated due to poor accrual.|||||
751369|NCT00550654|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|9 months, 11 days|||Participants|||Number
751370|NCT00550654|Primary|6-month Local Control (i.e., Complete Response, Partial Response, or Stable Disease) at All Treated Sites of Metastatic Disease|Local control (e.g. absence of local progression) is defined as Complete response (CR), partial response (PR) or stable disease (SD) of the treated site(s). Complete response is the disappearance of the target lesion. Partial response is a >/= 50% decrease in maximal dimension compared to pretreatment imaging. Stable disease does not qualify for CR, PR, or progression.Progression is an interval increase in the maximal dimension of the target lesion.|6 months|No data/specimens were collected. Study was terminated due to poor accrual.|||||
751371|NCT00550680|Secondary|Number of Participants Prematurely Withdrawn From the Study to Receive Blood Transfusion|The number of participants who were prematurely withdrawn from the study to receive a blood transfusion during treatment, including the DTP (Weeks 0 and 16) and/or EEP (Weeks 17 to 24), was reported.|Continuously and at every visit from Week 0 (every week until Week 2, thereafter every 2 weeks) through Week 24|All Enrolled Population: Includes all participants enrolled into the study regardless of treatment received.||participants|||Number
751372|NCT00550680|Secondary|Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA During the Dose Titration Period (DTP) and EEP|Study drug administration occurred monthly during the DTP (Weeks 0 to 16), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during Week -1. Subsequent doses could be adjusted throughout the study including during the EEP (Weeks 17 to 24) on the basis of Hb levels or other modification criteria. The percentage of participants who required a dose adjustment for any reason was calculated during the DTP and EEP.|Weeks 0, 4, 8, 12, 16, 20, and 24|ITT Population; number (n) of participants who entered each treatment period was reported.||percentage of participants|||Number
751373|NCT00550680|Secondary|Mean Time Spent in the Target Range for Hb During the EEP|During the EEP (Weeks 17 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with Mircera/CERA. Time spent in the target range of 10.5 to 12.5 g/dL was defined as time from first on-target Hb to time of last known on-target Hb, as collected during the EEP. Time spent in the target range was averaged among all participants and expressed in days.|Pre-dose (0 hours) during Weeks 18, 20, 22, and 24|ITT Population||days||Standard Deviation|Mean
751374|NCT00550680|Secondary|Percentage of Participants Whose Hb Remained Within Target Range Throughout the EEP|During the EEP (Weeks 17 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with CERA/Mircera. The percentage of participants who maintained each single Hb measurement in the target range of 10.5 to 12.5 g/dL was determined. The 95% CI was calculated using the Pearson-Clopper method for exact confidence bounds.|Pre-dose (0 hours) during Weeks 18, 20, 22, and 24|ITT Population||percentage of participants||95% Confidence Interval|Number
751375|NCT00550680|Secondary|Mean Change in Time-Adjusted Hb From Baseline to EEP|"Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment stability assessment (Weeks -4 to 0). During the EEP (Weeks 17 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with Mircera/CERA. The average Hb during the EEP was calculated per participant and assessed against the reference value. The mean change in Hb value between reference (i.e., Baseline) Hb and the EEP average Hb was calculated and expressed in g/dL."|At Weeks -4, -3, -2, -1, and 0; pre-dose (0 hours) during Weeks 18, 20, 22, and 24|Intent-to-Treat (ITT) Population: All participants who received at least one dose of Mircera/CERA and provided data for at least one follow-up assessment.||g/dL||Standard Deviation|Mean
751376|NCT00550680|Primary|Percentage of Participants Who Maintained Average Hb Within Plus/Minus (±) 1 g/dL of Reference Hb and Within Target Range During the Efficacy Evaluation Period (EEP)|Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment stability assessment (Weeks -4 to 0). During the EEP (Weeks 17 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with Mircera/CERA. The average Hb during the EEP was calculated per participant and assessed against the reference value. The percentage of participants who had average Hb during the EEP in the target range of 10.5 to 12.5 g/dL and within ±1 g/dL of their individual reference Hb was determined as the primary endpoint. The 95 percent (%) confidence interval (CI) was calculated using the Pearson-Clopper method for exact confidence bounds.|Weeks -4, -3, -2, -1,and 0; pre-dose (0 hours) during Weeks 18, 20, 22, and 24|Per Protocol (PP) Population: All participants who received at least one dose of Mircera/CERA and provided data for at least one follow-up assessment, and who fulfilled inclusion/exclusion criteria per study protocol.||percentage of participants||95% Confidence Interval|Number
751377|NCT00550732|Secondary|Number of Participants Experiencing Adverse Events (AEs)|An adverse event (AE) is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the study drug.|Up to 12 months|All enrolled participants who received at least one dose of study medication.||Number of participants|||Number
751378|NCT00550732|Secondary|Number of Participants With Response to Posaconazole in Combination Therapy|Complete Response was defined as resolution of all attributable clinical signs and symptoms and radiologic and mycologic abnormalities, if present at baseline. Partial Response was defined as clinically meaningful improvement in attributable clinical signs and symptoms and radiologic and mycologic abnormalities, if present at baseline.|Up to 6 months|The proportion of participants with response to posaconzole who received a prior combination antifungal regimen is not reported as per recommendation from the Safety and Steering Committee since only 1 participant was evaluable for this outcome measure.|||||
751380|NCT00550732|Secondary|Percentage of Participants With Infection-free Survival After the Last Dose of Study Drug|Infection-free survival was the proportion of evaluable participants included in the efficacy analysis who are infection-free and alive at 6 months post last dose visit. Infection-free is defined as the resolution of signs and symptoms of infection.|Up to 6 months|The Efficacy Population included those participants with a visit 6 months after the last dose.||Percentage of participants|||Number
751381|NCT00550732|Secondary|Percentage of Participants With CR or PR by 4 Weeks and by 26 Weeks|Complete Response was defined as resolution of all attributable clinical signs and symptoms and radiologic and mycologic abnormalities, if present at baseline. Partial Response was defined as clinically meaningful improvement in attributable clinical signs and symptoms and radiologic and mycologic abnormalities, if present at baseline.|Up to 26 weeks|The Efficacy Population included those participants with both a baseline and at least 1 post-baseline assessment.||Percentage of Participants|||Number
751382|NCT00550732|Secondary|Percentage of Participants With a CR or PR by 12 Weeks|Complete Response was defined as resolution of all attributable clinical signs and symptoms and radiologic and mycologic abnormalities, if present at baseline. Partial Response was defined as clinically meaningful improvement in attributable clinical signs and symptoms and radiologic and mycologic abnormalities, if present at baseline.|Up to 12 Weeks|The Efficacy Population included those participants with both a baseline and at least 1 post-baseline assessment.||Percentage of participants|||Number
751383|NCT00550732|Secondary|Number of Participants With ≥50% Decrease in Lesion Size or Number|Reduction in lesion size was analyzed by computed tomography (CT) scan. An imaging response was defined as >=50% reduction in lesion size for pulmonary and cerebral disease or >=50% reduction in the number of lesions for liver disease.|Up to 6 months|This outcome measure was not reported as the Safety and Steering Committee (SSC) no longer considered it relevant based on revised Mycoses Study Group and European Organization for Research and Treatment of Cancer (MSG/EORTC) Consensus Criteria.|||||
751384|NCT00550732|Primary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) by 12 Weeks or End of Treatment|Complete Response was defined as resolution of all attributable clinical signs and symptoms and radiologic and mycologic abnormalities, if present at baseline. Partial Response was defined as clinically meaningful improvement in attributable clinical signs and symptoms and radiologic and mycologic abnormalities, if present at baseline.|Up to 6 months|The Efficacy Population included those participants with both a baseline and at least 1 post-baseline assessment.||Percentage of participants|||Number
751385|NCT00550745|Secondary|Serious Adverse Events Reported Within 6 Months (Day 1 to 182) Postvaccination|"Only Serious Adverse Events were collected and analyzed for this study.
A serious adverse event is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an other important medical event based on medical judgement."|6 months|"All subjects who were vaccinated according to actual treatment received (ZOSTAVAX™ or placebo) and had safety follow-up.
Death - Number of subjects that had a fatal serious adverse event with an onset date within the 182 day reporting period. The date of death may have occurred after 182 days."||Participants|||Number
751386|NCT00550745|Primary|Serious Adverse Events Reported Within 42 Days Postvaccination|"Only Serious Adverse Events were collected and analyzed for this
study.
A serious adverse event is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an other important medical event based on medical judgement."|42 Days|"All subjects who were vaccinated according to actual treatment received (ZOSTAVAX™ or placebo) and had safety follow-up.
Death - Number of subjects that had a fatal serious adverse event with an onset date within the 42 day reporting period. The date of death may have occurred after 42 days."||Participants|||Number
751387|NCT00550771|Secondary|Number of Participants Who Survived Without Relapse|"Relapse-free survival would have been determined by Kaplan-Meier method.
This was not calculated, since the 2 year follow-up was curtailed."|Approximately 2 years||||||
751388|NCT00550771|Secondary|Number of Participants Who Experienced Cardiac Events (Level 1 or 2) or Inability to Administer Trastuzumab During 1 Year of Trastuzumab Therapy|"Cardiac events defined as:
Level 1: Cardiac death due to heart failure (HF), myocardial infarction or arrhythmia, or probable cardiac death defined as sudden, unexpected death within 24 hours of a definite or probable cardiac event, or severe symptomatic HF, concomitant with a left ventricular ejection fraction (LVEF) drop of >10 percentage points from baseline and to ≤50% LVEF
Level 2: Asymptomatic systolic dysfunction or mildly symptomatic HF concomitant with an LVEF drop of >10 percentage points from baseline and to <50% LVEF; the LVEF drop was to have been confirmed within 3-4 weeks."|During 1 year of trastuzumab therapy|ITT, defined as all participants who were randomized and received at least 1 dose of any study medication.||Participants|||Number
751389|NCT00550771|Secondary|Number of Participants Who Experienced Cardiac Events (Level 1 or 2) or Inability to Administer Trastuzumab During the 8 Cycles of Chemotherapy|"Cardiac events defined as:
Level 1: Cardiac death due to heart failure (HF), myocardial infarction or arrhythmia, or probable cardiac death defined as sudden, unexpected death within 24 hours of a definite or probable cardiac event, or severe symptomatic HF, concomitant with a left ventricular ejection fraction (LVEF) drop of >10 percentage points from baseline and to ≤50% LVEF
Level 2: Asymptomatic systolic dysfunction or mildly symptomatic HF concomitant with an LVEF drop of >10 percentage points from baseline and to <50% LVEF; the LVEF drop was to have been confirmed within 3-4 weeks."|During the 8 courses of chemotherapy|ITT, defined as all participants who were randomized and received at least 1 dose of any study medication.||Participants|||Number
751407|NCT00556478|Secondary|Change in the Index of Premature Ejaculation (IPE) Domains of Ejaculatory Control, Distress and Sexual Satisfaction From Baseline to Month 2|"Change in the IPE domains of ejaculatory control, distress and sexual satisfaction from Baseline to month 2
Ejaculatory control scores range from 4 to 20 with a higher score indicating greater ejaculatory control Sexual satisfaction scores range from 4 to 20 with a higher score indicating greater sexual satisfaction Distress scores range from 2 to 10 with a higher score indicating less distress"|2 months|ITT||Score||Standard Deviation|Mean
752481|NCT00569270|Primary|Bronchodilator Response:Peak FRC (L) (Functional Residual Capacity)|Lung function studies (mean +/- SD): peak FRC after 30 days (+2h) of placebo or tiotropium in 29 moderate COPD patients.|30 days|Includes groups randomized to receive placebo first and Tiotropium first.||Liters||Standard Deviation|Mean
751390|NCT00550771|Primary|Number of Participants Who Experienced Cardiac Events (Level 1 or 2), or Inability to Administer Trastuzumab Either During the 8 Cycles of Chemotherapy or According to Package Insert for a Total Duration of 1 Year|"Cardiac events defined as:
Level 1: Cardiac death due to heart failure (HF), myocardial infarction or arrhythmia, or probable cardiac death defined as sudden, unexpected death within 24 hours of a definite or probable cardiac event, or severe symptomatic HF, concomitant with a left ventricular ejection fraction (LVEF) drop of >10 percentage points from baseline and to ≤50% LVEF
Level 2: Asymptomatic systolic dysfunction or mildly symptomatic HF concomitant with an LVEF drop of >10 percentage points from baseline and to <50% LVEF; the LVEF drop was to have been confirmed within 3-4 weeks."|8 cycles of chemotherapy and subsequently one year of planned trastuzumab treatment|"ITT, defined as all participants who were randomized and received at least 1 dose of any study medication.
Each participant could not contribute more than 1 event."||Participants|||Number
751391|NCT00550836|Secondary|Frequency and Severity of Observed Adverse Effects|"Patients are assessed for Adverse events each cycle using the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0). The maximum grade for each type of adverse event will be recorded for each patient, and tables will be reviewed to determine adverse event patterns. The number of patients in each arm that reported a grade 3 or higher adverse event and a grade 4 or higher adverse event are reported.
A complete listing of all adverse events is reported in the Adverse Events section."|Up to 2 years|All evaluable patients were included in this analysis.||participants|||Number
751392|NCT00550836|Secondary|Time to Treatment Failure|Time to treatment failure is defined to be the time from the date of randomization to the date at which the patient is removed from treatment due to progression, adverse events, or refusal. If the patient is considered to be a major treatment violation or is taken off study as a nonprotocol failure, the patient will be censored on the date they are removed from treatment. The time to treatment failure will be estimated using the method of Kaplan-Meier.|Up to 2 years|All eligible treated patients were included in this analysis.||months||95% Confidence Interval|Median
751393|NCT00550836|Secondary|Progression-free Survival|Progression-free survival is defined as the time from randomization to documentation of disease progression or death, whichever comes first. Progression is defined as at least a 20% increase in the sum of longest dimension (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. The distribution of progression-free survival will be estimated using the method of Kaplan-Meier. The progression-free survival curves will be compared between the 2 arms using a log-rank test.|Up to 2 years|All treated patients were included in this analysis.||months||95% Confidence Interval|Median
751394|NCT00550836|Secondary|Confirmed Response Rate|Evaluated using RECIST version 1.0. Confirmed tumor response rate was defined as achieving partial response (PR) or complete response (CR) in two consecutive assessments at least 6 weeks apart. CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. The confirmed response rate is reported as the number of participants with confirmed responses divided by the number of evaluated participants.|Up to 2 years|All patients that started protocol treatment and were evaluated were included in this analysis.||rate of confirmed response||95% Confidence Interval|Number
751395|NCT00550836|Primary|Overall Survival|Overall Survival is defined as the time from registration to death due to any cause. The estimate will be done using the Kaplan-Meier method. The primary goal of this trial is to compare the experimental arm (Arm B) to the standard arm (Arm A). The primary analysis will be a comparison of Arm A to Arm B using a one-sided log-rank test between the 2 Kaplan-Meier curves.|Up to 2 years|All treated patients that were eligible were included in the analysis.||months||95% Confidence Interval|Median
751396|NCT00550862|Secondary|Plasma Trough Concentrations of INT-747 and Its Major, Known Metabolites||12 Weeks||||||
751397|NCT00550862|Secondary|Alanine Aminotransferase (ALT)|Mean percent change in serum alanine aminotransferase (ALT) from baseline to Day 85/early termination.|Baseline and 12 weeks|||Percent (%) change||Standard Deviation|Mean
751398|NCT00550862|Secondary|Serum Gamma-Glutamyl Transpeptidase (GGT)|Percent change in serum gamma-glutamyl transpeptidase (GGT) from baseline to Day 85/early termination.|Baseline and 12 weeks|||Percent (%) change||Standard Deviation|Mean
751399|NCT00550862|Primary|Alkaline Phosphatase (ALP).|The primary efficacy endpoint was the relative (%) change in plasma ALP from pretreatment values. The prestudy consensus opinion of the investigators was that a placebo-substracted ALP fall of ≥ 10% would be clinically significant.|Baseline and 12 weeks|||Percent (%) change||Standard Deviation|Mean
751400|NCT00556452|Primary|One-year Overall Survival Rate for AML|Percent Overall Survival (OS) for at one year for subjects with Acute Myeloid Leukemia (AML).|1 year|Patients with Acute Myeloid Leukemia (AML)||percent overall survival||95% Confidence Interval|Number
751401|NCT00556452|Secondary|Five-year Overall and Disease-free Survival of All Cases.||five years||||||
751402|NCT00556452|Secondary|Two-year Overall Survival for All Cases.|Percent Overall Survival (OS) at two years for all patients.|2 years|||percent overall survival||95% Confidence Interval|Number
751403|NCT00556452|Primary|Regimen Related Toxicities|The incidence of non-hematological toxicities (Common Terminology Criteria for Adverse Events (CTCAE) 3.0) from initiation of conditioning to Day + 30 or toxicities after day +30, possibly, probably or definitely related to conditioning for all patients treated with Clofarabine (independent of dose level).|two years|||toxicities|||Number
751404|NCT00556478|Secondary|Partner Premature Ejaculation Profile (PEP) at Month 3|Scores for perceived control over ejaculation, personal distress related to ejaculation, satisfaction with sexual intercourse and interpersonal difficulty related to ejaculation based on the partner PEP at month 3. Proportion of partners with at least a 1 point category improvement in partner PEP domain scores from baseline to month 3.|3 months|ITT||percentage of partners|||Number
751405|NCT00556478|Secondary|Subject Premature Ejaculation Profile (PEP) at Month 3|Scores for perceived control over ejaculation, personal distress related to ejaculation, satisfaction with sexual intercourse and interpersonal difficulty related to ejaculation based on the subject PEP at month 3. Proportion of subjects with at least a 1 point category improvement in subject PEP domain scores from baseline to month 3.|3 months|ITT||percentage of participants|||Number
751560|NCT00558571|Secondary|LI (Linearity Index).|The linearity index is defined as AUC0-τ divided by AUC0-∞ both at steady state.|0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 after drug administration on day 1 and 28|PK analysis set||ratio||Geometric Coefficient of Variation|Geometric Mean
751409|NCT00556478|Secondary|Change in the Index of Premature Ejaculation (IPE) Domains of Ejaculatory Control, Distress and Sexual Satisfaction From Baseline to Month 1|"Change in the IPE domains of ejaculatory control, distress and sexual satisfaction from Baseline to month 1.
Ejaculatory control scores range from 4 to 20 with a higher score indicating greater ejaculatory control Sexual satisfaction scores range from 4 to 20 with a higher score indicating greater sexual satisfaction Distress scores range from 2 to 10 with a higher score indicating less distress"|1 month|ITT||Score||Standard Deviation|Mean
751410|NCT00556478|Secondary|Change in Mean Intravaginal Ejaculatory Latency Time (IELT) From Baseline to Month 3|Summary of mean IELT at Baseline and at month 3 during double-blind treatment|3 months|ITT||Seconds||Standard Deviation|Geometric Mean
751411|NCT00556478|Secondary|Percentage of Subjects With Mean Intravaginal Ejaculatory Latency Time (IELT) > 1 Minute and >2 Minutes During the 3 Months of Double-blind Treatment|Percentage of subjects with mean IELT > 1 minute and >2 minutes during the 3 months of double-blind treatment as measured by the proportion of subjects|3 months|ITT||percentage of subjects|||Number
751412|NCT00556478|Primary|Index of Premature Ejaculation (IPE): Change From Baseline to End of Month 3|"To Evaluate Efficacy of Treatment With PSD502 Compared With Placebo in Subjects With PE as measured by:
• changes in all 3 IPE domains from baseline to month 3
Ejaculatory control scores range from 4 to 20 with a higher score indicating greater ejaculatory control Sexual satisfaction scores range from 4 to 20 with a higher score indicating greater sexual satisfaction Distress scores range from 2 to 10 with a higher score indicating less distress"|Baseline to 3 Months|ITT||Score||Full Range|Mean
751413|NCT00556478|Primary|Mean Intravaginal Ejaculatory Latency Time (IELT): Change From Baseline to During 3 Month Double Blind-treatment|"To evaluate efficacy of treatment with PSD502 compared with placebo in subjects with PE as measured by:
• change in mean IELT from baseline to during the 3 month double-blind treatment
Results provide are ratio (over the 3 months/baseline)."|Baseline to 3 Months|ITT||ratio||Full Range|Geometric Mean
751414|NCT00556491|Secondary|Composite End-point of Secondary Outcomes of Death, Hospital Days, Major Complications||30 days post-operative||||||
751415|NCT00556491|Primary|Development of Post-operative Acute Kidney Injury|Participants who develop a Creatinine increase by 0.3 mg/dl (AKIN definition) in any 48 hours time period, within 5 days post-operatively|up to 5 days post cardiac surgery|||participants meeting primary oputcome|||Number
751416|NCT00556504|Secondary|Immune Cell Normalization|Normalization of immune cells, CD4, CD8 and NK cells at 24 weeks after cessation of combination drug treatment.|24 weeks after the termination of combinational drug treatment (up to 72 weeks)|||participants|||Number
751417|NCT00556504|Secondary|Immune Cell Normalization|"Normalization of immune cells, CD4, CD8 and NK cells at the end of combination drug treatment
(Immune cell normalization is defined as return of CD4, CD8 and NK cells to normal range)"|at the end of combination drug treatment (up to 48 weeks)|||participants|||Number
751418|NCT00556504|Secondary|Combined ALT and Virologic Response|Combined ALT and virologic response at the end of combination drug treatment.|at the end of combination drug treatment (up to 48 weeks)|||participants|||Number
751419|NCT00556504|Secondary|Sustained ALT Response|a sustained ALT response is defined as sustained normalization of ALT 24 weeks after cessation of combination drug treatment.|24 weeks after the termination of combinational drug treatment (up to 72 weeks)|||participants|||Number
751420|NCT00556504|Secondary|ALT Response|"An ALT response is defined as normalization of ALT at the end of combination drug treatment.
(ALT normalization is defined as ALT level decreases into within the normal range)"|at the end of combination drug treatment (up to 48 weeks)|||participants|||Number
751421|NCT00556504|Secondary|Virologic Response|"undetectable HCV RNA at the end of combination drug treatment
Serum HCV RNA will be tested using a commercially available real-time polymerase-chain-reaction (PCR) assay kit (Roche Cobas TaqMan HCV assay kit)."|at the end of combination drug treatment (up to 48 weeks)|||participants|||Number
751422|NCT00556504|Primary|Sustained Virologic Response (SVR)|"SVR is defined as no detectable HCV RNA in serum of patient at Week 72, which is 24 weeks after the termination of combination drug treatment..
A subject is a sustained responder at a given week, if the subject has negative HCV RNA at that week and all the subsequent weeks through Week 72.
If a patient has a missing value between visits, then the last non-missing HCV RNA is carried forward to fill in the missing value.
If the patient’s HCV RNA at last visit, Week 72 is missing or above the limit of detection, then the patient is a non-responder, even if all the previous visits from baseline onwards were undetectable.
Serum HCV RNA will be tested using a commercially available real-time polymerase-chain-reaction (PCR) assay kit (Roche Cobas TaqMan HCV assay kit)"|24 weeks after the termination of combinational drug treatment (up to 72 weeks)|||Number of participants with SVR|||Number
751423|NCT00556543|Primary|The McGill Pain Questionnaire (MPQ) - Pain Rating Index (PRI)|The MPQ evaluates subjective pain using word descriptors (PPI, present pain intensity) and an intensity scale (PRI, pain rating index). The rank value for each word descriptor is based on its position in the word set. The sum of the rank values is the pain rating index (PPI). The maximum pain score using word descriptors is 78, with a higher score reflecting greater pain.|results at 60, 120, and 180 days post-repair with results posted for 180 days|Per Protocol||PRI||Standard Deviation|Mean
751424|NCT00556543|Primary|The McGill Pain Questionnaire (MPQ) - Present Pain Intensity (PPI)|The MPQ evaluates subjective pain using word descriptors (PPI, present pain intensity) and an intensity scale (PRI, pain rating index). The rank value for each word descriptor is based on its position in the word set. The sum of the rank values is the pain rating index (PPI). The maximum pain score using word descriptors is 78, with a higher score reflecting greater pain.|results at 60, 120, and 180 days post-repair with results posted for 180 days|Per Protocol||PPI||Standard Deviation|Mean
751425|NCT00556543|Primary|The Rand 36-Item Health Survey Results - General Health Scale|The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study.|results at 60, 120, and 180 days post-repair with results posted for 180 days|Per Protocol||RAND-36 scale units||Standard Deviation|Mean
755299|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for ‘Ears, Eyes, Nose, Mouth, Throat’||28 days|Safety Set, only patients with non-missing values were analyzed||participants|||Number
751426|NCT00556543|Primary|The Rand 36-Item Health Survey Results - Bodily Pain Scale|The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study.|results at 60, 120, and 180 days post-repair with results posted for 180 days|Per Protocol||RAND-36 scale units||Standard Deviation|Mean
751427|NCT00556543|Primary|The Rand 36-Item Health Survey Results - Social Functioning Scale|The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study.|results at 60, 120, and 180 days post-repair with results posted for 180 days|Per Protocol||RAND-36 scale units||Standard Deviation|Mean
751428|NCT00556543|Primary|The Rand 36-Item Health Survey Results - Emotional Well-being Scale|The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study.|results at 60, 120, and 180 days post-repair with results posted for 180 days|Per Protocol||RAND-36 scale units||Standard Deviation|Mean
751429|NCT00556543|Primary|The Rand 36-Item Health Survey Results - Vitality Scale|The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study.|results at 60, 120, and 180 days post-repair with results posted for 180 days|Per Protocol||RAND-36 scale units||Standard Deviation|Mean
751430|NCT00556543|Primary|The Rand 36-Item Health Survey Results - Role Limitations - Emotional Scale|The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study.|results at 60, 120, and 180 days post-repair with results posted for 180 days|Per Protocol||RAND-36 scale units||Standard Deviation|Mean
751431|NCT00556543|Primary|The Rand 36-Item Health Survey Results - Role Limitations - Physical Scale|The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study.|results at 60, 120, and 180 days post-repair with results posted for 180 days|Per Protocol||RAND-36 scale units||Standard Deviation|Mean
751432|NCT00556543|Primary|The Rand 36-Item Health Survey Results - Physical Functioning Scale|The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study.|results at 60, 120, and 180 days post-repair with results posted for 180 days|Per Protocol||RAND-36 scale units||Standard Deviation|Mean
751433|NCT00556543|Primary|Adverse Post-op Events Related to the Repair and Plating System|Clinical evaluations or chest radiographs at a minimum of 1 and 6 months|180 days|Per Protocol||Participants|||Number
751434|NCT00556673|Secondary|Time to Reach Peak or Maximum Concentration Following Drug Administration for Indacaterol||Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, 12 and 24 hours post-dose.|All participants with evaluable pharmacokinetic (PK) parameter data were included in the PK data analysis.||hours||Full Range|Median
751435|NCT00556673|Secondary|Time to Reach Peak or Maximum Concentration Following Drug Administration for Mometasone Furoate||Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, 12 and 24 hours post-dose.|All participants with evaluable pharmacokinetic (PK) parameter data were included in the PK data analysis.||hours||Full Range|Median
751436|NCT00556673|Secondary|Maximum (Peak) Plasma Concentration (Cmax) of Indacaterol||Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, 12 and 24 hours post-dose.|All participants with evaluable pharmacokinetic (PK) parameter data were included in the PK data analysis.||pg/mL||Standard Deviation|Mean
751437|NCT00556673|Secondary|Maximum (Peak) Plasma Concentration (Cmax) of Mometasone Furoate||Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, 12 and 24 hours post-dose.|All participants with evaluable pharmacokinetic (PK) parameter data were included in the PK data analysis.||pg/mL||Standard Deviation|Mean
751438|NCT00556673|Secondary|Area Under the Concentration-time Curve From Time 0 to 24 Hours Post-dose for Indacaterol||Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, 12 and 24 hours post-dose.|All participants with evaluable pharmacokinetic (PK) parameter data were included in the PK data analysis.||pg*h/mL||Standard Deviation|Mean
751439|NCT00556673|Secondary|Area Under the Concentration-time Curve From Time 0 to 24 Hours Post-dose for Mometasone Furoate||Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, 12 and 24 hours post-dose.|All participants with evaluable pharmacokinetic (PK) parameter data were included in the PK data analysis.||pg*h/mL||Standard Deviation|Mean
751440|NCT00556673|Secondary|Area Under the Concentration-time Curve From Time 0 to 12 Hours Post-dose for Mometasone Furoate||Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, and 12 hours post-dose.|All participants with evaluable pharmacokinetic (PK) parameter data were included in the PK data analysis.||pg*h/mL||Standard Deviation|Mean
751441|NCT00556673|Secondary|Change From Period Baseline in Peak FEV1/FVC Ratio|The forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ratio represents the proportion of a person's vital capacity that they are able to expire in the first second of an expiration. Peak FEV1/FVC was calculated from spirometry measurements taken up to 4 hours post-dose. Change from baseline in peak FEV1/FVC ratio was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose value as covariate.|Days 1, 8 and 15, pre-dose (Baseline) and 5, 15, and 30 minutes, 1, 2, 3, and 4 hours post-dose.|Pharmacodynamic population||ratio||90% Confidence Interval|Least Squares Mean
751442|NCT00556673|Secondary|Change From Period Baseline in Trough FEV1/FVC Ratio|The forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ratio represents the proportion of a person's vital capacity that they are able to expire in the first second of an expiration. Trough FEV1/FVC was calculated from measurements taken 24 hours post-dose. Change from baseline in trough FEV1/FVC ratio was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose value as covariate.|Pre-dose for each Treatment Period (Days 1, 8 and 15) and 24-hours post-dose for each Treatment Period (Days 2, 9 and 16).|Pharmacodynamic population||ratio||90% Confidence Interval|Least Squares Mean
751443|NCT00556673|Secondary|Change From Period Baseline in Peak Forced Vital Capacity (FVC)|Vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Peak FVC was measured up to 4 hours post-dose. Change from baseline in peak FVC was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose value as covariate.|Days 1, 8 and 15, pre-dose (Baseline) and 5, 15, and 30 minutes, 1, 2, 3, and 4 hours post-dose.|Pharmacodynamic population||liters||90% Confidence Interval|Least Squares Mean
751444|NCT00556673|Secondary|Change From Period Baseline in Trough Forced Vital Capacity (FVC)|Vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Trough FVC was measured 24 hours post-dose. Change form baseline in trough FVC was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose value as covariate.|Pre-dose for each Treatment Period (Days 1, 8 and 15) and 24-hours post-dose for each Treatment Period (Days 2, 9 and 16).|Pharmacodynamic population||liters||90% Confidence Interval|Least Squares Mean
751445|NCT00556673|Secondary|Change From Period Baseline in Peak Percent Predicted Forced Expiratory Volume in 1 Second (FEV1)|"Peak FEV1 was defined as the peak FEV1 up to 4 hours post-dose. The FEV1 percent predicted expresses FEV1 as a percentage of the predicted values for participants of similar characteristics (height, age, sex, and sometimes race and weight). A positive change from baseline in FEV1 % predicted indicates improvement in lung function. Change from baseline in peak FEV1 % predicted was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose value as covariate."|Days 1, 8 and 15, pre-dose (Baseline) and 5, 15, and 30 minutes, 1, 2, 3, and 4 hours post-dose.|Pharmacodynamic population||Percent of predicted||90% Confidence Interval|Least Squares Mean
751446|NCT00556673|Secondary|Change From Period Baseline in Trough Percent Predicted Forced Expiratory Volume in 1 Second (FEV1)|"Trough FEV1 was measured 24 hours post-dose. The FEV1 percent predicted expresses FEV1 as a percentage of the predicted values for participants of similar characteristics (height, age, sex, and sometimes race and weight). A positive change from baseline in FEV1 % predicted indicates improvement in lung function. Change from baseline in trough FEV1 % predicted was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose value as covariate."|Pre-dose for each Treatment Period (Days 1, 8 and 15) and 24-hours post-dose for each Treatment Period (Days 2, 9 and 16).|Pharmacodynamic population||Percent of predicted||90% Confidence Interval|Least Squares Mean
751447|NCT00556673|Secondary|Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1)|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Peak FEV1 is defined as the peak FEV1 between 0 and 4 hours post-dose. The change from baseline in peak FEV1 was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose FEV1 as covariate.|Days 1, 8 and 15, pre-dose (Baseline) and 5, 15, and 30 minutes, 1, 2, 3, and 4 hours post-dose.|Pharmacodynamic population||liters||90% Confidence Interval|Least Squares Mean
751448|NCT00556673|Primary|Change From Period Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1)|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change from the period baseline to 24 hour post dose trough FEV1 after 1 day of treatment was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose FEV1 as covariate.|Pre-dose for each Treatment Period (Days 1, 8 and 15) and 24-hours post-dose for each Treatment Period (Days 2, 9 and 16).|Pharmacodynamic population included all patients randomized that received at least one dose of study drug and completed the first two treatment periods with evaluable data for the primary efficacy variable, and with no major protocol deviations. 7 patients who were inadvertently unblinded by the investigator were excluded from the PD analysis.||liters||90% Confidence Interval|Least Squares Mean
751449|NCT00556712|Secondary|Change From BL in FACT-L Scores (Data Cutoff 17 May 2008)|"Total FACT-L score=sum of TOI, SWB, and EWB of FACT-L questionnaires. TOI (PWB+FWB+LCS), SWB, and EWB scores obtained from 7-item (6-item for EWB) questionnaires from FACT-L V4. Participants responded to questions assessing symptoms (scale 0-4; 0=not at all and 4=very much). Higher score=more severe symptoms. The 7-item LCS assessed symptoms such as shortness of breath, loss of weight, tightness in chest. Participants responded to questions assessing symptoms (scale: 0-4; 0=not at all and 4=very much). Scores from 0-35; higher score=more severe symptoms. The 27 items of FACT-G were scored in the following domains: PWB (7 items, total score 0-28), SWB (7 items; total score 0-28), EWB (6 items, total score 0-24), and FWB (7 items; total score 0-28), higher scores=better QoL. Participants responded to items on 5-point Likert scale (0=Not at all to 4=Very much; total score: 0-108). Higher score=better QOL. TOI score=PWB+FWB+LCS; Total TOI score: 0-92; higher scores=better QOL."|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS; n=number of participants assessed for the given parameter at the specified timepoint.||score on a scale||Standard Deviation|Mean
751450|NCT00556712|Secondary|Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008)|"Total FACT-L score=sum of TOI, SWB, and EWB of FACT-L questionnaires. TOI (PWB+FWB+LCS), SWB, and EWB scores obtained from 7-item (6-item for EWB) questionnaires from FACT-L V4. Participants responded to questions assessing symptoms (scale 0-4; 0=not at all and 4=very much). Higher score=more severe symptoms. The 7-item LCS assessed symptoms such as shortness of breath, loss of weight, tightness in chest. Participants responded to questions assessing symptoms (scale: 0-4; 0=not at all and 4=very much). Scores from 0-35; higher score=more severe symptoms. The 27 items of FACT-G were scored in the following domains: PWB (7 items, total score 0-28), SWB (7 items; total score 0-28), EWB (6 items, total score 0-24), and FWB (7 items; total score 0-28), higher scores=better QoL. Participants responded to items on 5-point Likert scale (0=Not at all to 4=Very much; total score: 0-108). Higher score=better QOL. TOI score=PWB+FWB+LCS; Total TOI score: 0-92; higher scores=better QOL."|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS; n=number of participants assessed for the given parameter at the specified timepoint.||score on a scale||Standard Deviation|Mean
751451|NCT00556712|Secondary|Probable Percentage of Participants Remaining Without Deterioration in QoL at 6 Months (Data Cutoff 17 May 2008)|"Deterioration in QoL was defined as a clinically meaningful decline in the total FACT-L score, the sum of the TOI, SWB and EWB of the FACT-L questionnaires. TOI (PWB + FWB + LCS), SWB and EWB scores were obtained from 7-item (6-item in the case of EWB) questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = not at all and 4 = very much. Higher score indicated more severe symptoms. A clinically meaningful decline in FACT-L score was defined as at least a 6 point decline from BL. Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L. The 95% CI was estimated using Kaplan-Meier methodology."|6 months|FAS||percentage of participants||95% Confidence Interval|Number
751452|NCT00556712|Secondary|Time to Deterioration in QoL (Data Cutoff 17 May 2008)|"The median time, in weeks, from the date of randomization until a clinically meaningful decline from BL in total FACT-L or death, whichever occurred first. Total FACT-L score was defined as the sum of the TOI, SWB and EWB of the FACT-L questionnaires. TOI (PWB + FWB + LCS), SWB and EWB scores were obtained from 7-item (6-item in the case of EWB) questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = not at all and 4 = very much. Higher score indicated more severe symptoms. A clinically meaningful decline in FACT-L score was defined as at least a 6 point decline from BL. Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L assessment. The 95% CI was determined using Kaplan-Meier methodology."|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS||weeks||95% Confidence Interval|Median
751453|NCT00556712|Secondary|Percentage of Participants With Deterioration in Quality of Life Assessed Using TOI, SWB, and EWB (Data Cutoff 17 May 2008)|"Deterioration in quality of life (QoL) was defined as a clinically meaningful decline in the total FACT-L score, the sum of the TOI, Social/Family Well-Being (SWB) and Emotional Well-Being (EWB) of the FACT-L questionnaires. TOI (PWB + FWB + LCS), SWB and EWB scores were obtained from 7-item (6-item in the case of EWB) questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = not at all and 4 = very much. Higher score indicated more severe symptoms. A clinically meaningful decline in FACT-L score was defined as at least a 6 point decline from BL. Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L."|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS; 62 and 51 participants were not evaluated for this outcome measure from the Placebo and Erlotinib groups, respectively,||percentage of participants|||Number
751454|NCT00556712|Secondary|Probable Percentage of Participants Remaining Without Deterioration in TOI at 6 Months (Data Cutoff 17 May 2008)|"TOI was defined as the sum of the scores of the PWB, FWB, and LCS. PWB, FWB, and LCS scores were obtained from 7-item questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = not at all and 4 = very much. Higher score indicated more severe symptoms. A clinically meaningful decline in TOI score was defined as at least a 6 point decline from BL. Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L assessment. The 95% CI was estimated using Kaplan-Meier methodology."|6 months|FAS||percentage of participants||95% Confidence Interval|Number
751455|NCT00556712|Secondary|Time to Deterioration in TOI (Data Cutoff 17 May 2008)|"The median time, in weeks, from the date of randomization until a clinically meaningful decline from BL in TOI or death, whichever occurred first. TOI was defined as the sum of PWB, FWB, and LCS scores, which were obtained from 7-item questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = not at all and 4 = very much. Higher score indicated more severe symptoms. A clinically meaningful decline in TOI score was defined as at least a 6 point decline from BL Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L assessment. The 95% CI was determined using Kaplan-Meier methodology."|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS||weeks||95% Confidence Interval|Median
751469|NCT00556712|Secondary|Probable Percentage of Participants in the EGFR IHC Negative Population Remaining Alive at 1 Year (Data Cutoff 17 May 2008)|OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology.|1 year|FAS; only participants with EGFR IHC negative tumors were included in the analysis.||percentage of participants||95% Confidence Interval|Number
751606|NCT00559273|Secondary|Percentage of Participants With Red Blood Cell (RBC) Transfusions|The percentage of participants who received RBC transfusions during the titration and evaluation periods were reported.|Baseline up to Week 28|ITT population.||percentage of participants|||Number
751456|NCT00556712|Secondary|Percentage of Participants With Deterioration Assessed Using the Trial Outcome Index (Data Cutoff 17 May 2008)|"The Trial Outcome Index (TOI) was defined as the sum of the scores of the Physical Well-Being (PWB), Functional Well-Being (FWB), and LCS. PWB, FWB, and LCS scores were obtained from 7-item questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = not at all and 4 = very much. Higher score indicated more severe symptoms. A clinically meaningful decline in TOI score was defined as at least a 6 point decline from BL. Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L assessment."|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS; 59 and 49 participants were not evaluated for this outcome measure from the Placebo and Erlotinib groups, respectively.||percentage of participants|||Number
751457|NCT00556712|Primary|Probable Percentage of Participants in the EGFR IHC Positive Population Remaining Alive and Progression Free at 6 Months (Data Cutoff 17 May 2008)|PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology.|6 months|FAS; only participants with EGFR IHC positive tumors were included in the analysis.||percentage of participants||95% Confidence Interval|Number
751458|NCT00556712|Primary|PFS in EGFR IHC Positive Population (Data Cutoff 17 May 2008)|The median time, in weeks, from randomization to PFS event. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology.|Screening, BL (≤ 21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS;only participants with EGFR IHC positive tumors were included in the analysis.||weeks||95% Confidence Interval|Median
751459|NCT00556712|Secondary|Probable Percentage of Participants Remaining Without Symptom Progression at 6 Months (Data Cutoff 17 May 2008)|"LCS scores were obtained from a 7-item questionnaire from the FACT-L V 4. Participants responded to questions assessing symptoms commonly reported by lung cancer patients; such as shortness of breath, loss of weight, and tightness in chest; on a scale from 0-4, where 0 = not at all and 4 = very much. The participants' responses were summed to result in an overall score, where a higher score indicated more severe symptoms. A change of 2 to 3 points in score was determined to be a clinically meaningful decline. The 95% CI was estimated using Kaplan-Meier methodology."|6 months|FAS||percentage of participants||95% Confidence Interval|Number
751460|NCT00556712|Secondary|Time to Symptom Progression (Data Cutoff 17 May 2008)|"The median time, in weeks, from the date of randomization to the date of documented clinically meaningful decline in LCS from BL or death, whichever occurred first. LCS scores were obtained from a 7-item questionnaire from the FACT-L V 4. Participants responded to questions assessing symptoms commonly reported by lung cancer patients; such as shortness of breath, loss of weight, and tightness in chest; on a scale from 0-4, where 0 = not at all and 4 = very much. The participants' responses were summed to result in an overall score, where a higher score indicated more severe symptoms. A change of 2 to 3 points in score was determined to be a clinically meaningful decline. The 95% CI was determined using Kaplan-Meier methodology."|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS||weeks||95% Confidence Interval|Median
751461|NCT00556712|Secondary|Percentage of Participants With Symptom Progression Assessed Using the Lung Cancer Subscale (LCS) (Data Cutoff 17 May 2008)|"LCS scores were obtained from a 7-item questionnaire from the Functional Assessment of Cancer Therapy - Lung (FACT-L) version (V) 4. Participants responded to questions assessing symptoms commonly reported by lung cancer patients; such as shortness of breath, loss of weight, and tightness in chest; on a scale from 0-4, where 0 equaled (=) not at all and 4 = very much. The participants' responses were summed to result in an overall score, where a higher score indicated more severe symptoms. A change of 2 to 3 points in score was determined to be a clinically meaningful decline."|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS; 56 and 48 participants were not evaluated for this outcome measure from the Placebo and Erlotinib groups, respectively.||percentage of participants|||Number
751462|NCT00556712|Secondary|Percentage of Participants With CR, PR, or SD or With SD [Maintained For Greater Than (>) 12 Weeks] or CR or PR (Data Cutoff 17 May 2008)|Disease control was defined as a best response of CR or PR or SD or a best response of SD for more than 12 weeks, or CR or PR. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD/incomplete response was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits. The 95% CI for one sample binomial was determined using the Pearson-Clopper method.|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS; only participants with CR, PR or SD at BL as determined by the Investigator were included in the analysis.||percentage of participants||95% Confidence Interval|Number
751470|NCT00556712|Secondary|OS in EGFR IHC Negative Participants (Data Cutoff 17 May 2008)|OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology.|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS; only participants with EGFR IHC negative tumors were included in the analysis.||months||95% Confidence Interval|Median
751463|NCT00556712|Secondary|Percentage of Participants With a Change of PR to CR or SD to PR or CR From BL to End of Treatment According to RECIST (Data Cutoff 17 May 2008)|For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD/incomplete response was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits; and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. The 95% CI for one sample binomial was determined using the Pearson-Clopper method.|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS; only participants with CR, PR or SD at BL as determined by the Investigator were included in the analysis.||percentage of participants||95% Confidence Interval|Number
751464|NCT00556712|Secondary|Percentage of Participants With a Response Upgrade From BL According to RECIST (Data Cutoff 17 May 2008)|Response upgrade was defined by a change of PR to CR or of SD to PR or CR from BL to the end of treatment. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD/incomplete response was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits; and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. The 95% CI for one sample binomial was determined using the Pearson-Clopper method.|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS; only participants with CR, PR or SD at BL as determined by the Investigator were included in the analysis.||percentage of participants||95% Confidence Interval|Number
751465|NCT00556712|Secondary|Percentage of Participants With a CR, PR, Stable Disease (SD), or PD According to RECIST (Data Cutoff 17 May 2008)|For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD/incomplete response was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits; and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. The 95% CI for one sample binomial was determined using the Pearson-Clopper method.|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS; only participants with CR, PR or SD at BL as determined by the Investigator were included in the analysis; and 7 and 17 participants were not assessed from the Placebo and Erlotinib, 150 mg/day groups, respectively.||percentage of participants||95% Confidence Interval|Number
751466|NCT00556712|Secondary|Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST (Data Cutoff 17 May 2008)|BOR was defined as CR or PR confirmed by repeat assessments performed no less than 4 weeks after the criteria for response was first met. For TLs, CR was defined as the disappearance of all TLs, and PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline (BL) SLD. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. The 95% CI for one sample binomial was determined using the Pearson-Clopper method.|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS; only participants with CR, PR or SD at BL as determined by the Investigator were included in the analysis.||percentage of participants||95% Confidence Interval|Number
751467|NCT00556712|Secondary|Probable Percentage of Participants Remaining Progression-Free in the TTP Analysis at 6 Months (Data Cutoff 17 May 2008)|TTP was defined as the time from the date of randomization to the first date PD was recorded. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD were censored at the date of last tumor assessment where non-progression was documented. If a participant received a second anti-cancer therapy without prior documentation of PD, the participant was censored at the date of last tumor assessment before starting new chemotherapy. The 95% CI was estimated using Kaplan-Meier methodology.|6 months|FAS; participants with PD prior to randomization were excluded from analysis.||percentage of participants||95% Confidence Interval|Number
751468|NCT00556712|Secondary|Time to Progression (Data Cutoff 17 May 2008)|The median time, in weeks, between randomization and TTP event. Participants without PD were censored at the date of last tumor assessment where non-progression was documented. If a participant received a second anti-cancer therapy without prior documentation of PD, the participant was censored at the date of last tumor assessment before starting new chemotherapy.|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS; participants with PD prior to randomization were excluded from analysis.||weeks||95% Confidence Interval|Median
751471|NCT00556712|Secondary|Percentage of EGFR IHC Negative Participants Who Died (Data Cutoff 17 May 2008)||Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS; only participants with EGFR IHC negative tumors were included in the analysis.||percentage of participants|||Number
751472|NCT00556712|Secondary|Probable Percentage of Participants in the EGFR IHC Negative Population Remaining Alive and Free of Disease Progression at 6 Months (Data Cutoff 17 May 2008)|PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology.|6 months|FAS; only participants with EGFR IHC negative tumors were included in the analysis.||percentage of participants||95% Confidence Interval|Number
751473|NCT00556712|Secondary|PFS in EGFR IHC Negative Participants (Data Cutoff 17 May 2008)|The median time, in weeks, from randomization to PFS event. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology.|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS; only participants with EGFR IHC negative tumors were included in the analysis.||weeks||95% Confidence Interval|Median
751474|NCT00556712|Secondary|Percentage of EGFR IHC Negative Participants With PD or Death (Data Cutoff 17 May 2008)|PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented.|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 71 months)|FAS; only participants with EGFR IHC negative tumors were included in the analysis.||percentage of participants|||Number
751475|NCT00556712|Secondary|Probable Percentage of Participants in the EGFR IHC Positive Population Remaining Alive at 1 Year (Data Cutoff 12 January 2012)|OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology.|1 year|FAS||percentage of participants||95% Confidence Interval|Number
751476|NCT00556712|Secondary|OS in EGFR IHC Positive Population (Data Cutoff 12 January 2012)|OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology.|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months)|FAS; only participants with EGFR IHC positive tumors were included in the analysis.||months||95% Confidence Interval|Median
751477|NCT00556712|Secondary|Percentage of EGFR IHC Positive Participants Who Died (Data Cutoff 12 January 2012)||Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months)|FAS; only participants with EGFR IHC positive tumors were included in the analysis.||percentage of participants|||Number
751478|NCT00556712|Secondary|Probable Percentage of Participants Remaining Alive at 1 Year (Data Cutoff 12 January 2012)|OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology.|1 year|FAS||percentage of participants||95% Confidence Interval|Number
751479|NCT00556712|Secondary|Overall Survival (OS) in All Participants (Data Cutoff 12 January 2012)|OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology.|Screening, BL (≤ 21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months)|FAS||months||95% Confidence Interval|Median
751480|NCT00556712|Secondary|Percentage of All Participants Who Died (Data Cutoff 12 January 2012)||Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months).|FAS||percentage of participants|||Number
751481|NCT00556712|Primary|Percentage of Epidermal Growth Factor Receptor (EGFR) Immunohistochemistry (IHC) Positive Participants With PD or Death (Data Cutoff 17 May 2008)|PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented.|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS; only participants with EGFR IHC positive tumors were included in the analysis.||percentage of participants|||Number
751511|NCT00558363|Secondary|Number of Participants Classified as Treatment Responders at Months 3, 6, 9, 12, 15, 18, 21, and 24|Treatment responders at Month X were defined as participants (par.) with either a PSA decrease or an increase <=15% from baseline to Month X confirmed in all PSA measurements between baseline (BL) and Month X.|Months 3, 6, 9, 12, 15, 18, 21, and 24|ITT Population. Par. not having a post-BL measurement could not be evaluated and were hence excluded from this analysis (3 in placebo arm, 1 in dutasteride arm). Different par. may contribute data at different time points (TP); the number of par. analyzed at each TP are those with BL as well as post-baseline data at the particular TP.||participants|||Number
751482|NCT00556712|Primary|Probable Percentage of Participants Remaining Alive and Free of Disease Progression at 6 Months (Data Cutoff 17 May 2008)|PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from BL more the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology.|6 months|FAS; participants with PD prior to randomization were excluded from analysis.||percentage of participants||95% Confidence Interval|Number
751483|NCT00556712|Primary|PFS in All Participants (Data Cutoff 17 May 2008)|The median time, in weeks, from randomization to PFS event. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% confidence interval (CI) was estimated using Kaplan-Meier methodology.|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS; participants with PD prior to randomization were excluded from analysis.||weeks||95% Confidence Interval|Median
751484|NCT00556712|Primary|Percentage of Participants With PD According to Response Evaluation Criteria in Solid Tumors (RECIST) or Death (Data Cutoff 17 May 2008)|Progression-free survival (PFS) was defined as the time from randomization to PD or death, whichever occurred first. For target lesions (TLs), PD was defined at least a 20 percent (%) increase in the sum of the largest diameter (SLD), taking as reference the smallest SLD recorded from baseline (BL) more the appearance of one or more new lesions. For non-target lesions (NTLs), PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented.|Screening, BL [≤21 days after randomization], every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS; participants with PD prior to randomization were excluded from analysis.||percentage of participants|||Number
751485|NCT00558285|Secondary|Change From Baseline in QTc (Fridericia's Formula) at Day 14|The change from baseline in QTc at 30 minutes, 4 hours and 23 hours 45 minutes post dose on day 14. QT calculated (QTc) was calculated from the QT interval and RR (in seconds) using Fridericia’s formula: QTc = QT / 3√ RR. Least square means are based on the analysis of covariance: response variable = center + treatment + baseline value + FEV1 before inhalation of salbutamol/albuterol + FEV1 30 minutes post inhalation of salbutamol/albuterol.|Baseline, Day 14|Safety Population includes all patients who received at least one dose of study drug.||milliseconds||Standard Error|Least Squares Mean
751486|NCT00558285|Secondary|Change From Baseline in QTc (Fridericia's Formula) at Day 7|The change from baseline in QTc at 30 minutes and 2 hours post dose on day 7. QT calculated (QTc) was calculated from the QT interval and RR (in seconds) using Fridericia’s formula: QTc = QT / 3√ RR. Least square means are based on the analysis of covariance: response variable = center + treatment + baseline value + FEV1 before inhalation of salbutamol/albuterol + FEV1 30 min post inhalation of salbutamol/albuterol.|Baseline, Day 7|Safety Population includes all patients who received at least one dose of study drug.||milliseconds||Standard Error|Least Squares Mean
751487|NCT00558285|Secondary|Change From Baseline in QTc (Fridericia's Formula) at Day 1|The change from baseline in QTc at 30 minutes, 4 hours and 23 hours 45 minutes post dose on day 1. QT calculated (QTc) was calculated from the QT interval and RR (in seconds) using Fridericia’s formula: QTc = QT / 3√ RR. Least square means are based on the analysis of covariance: response variable = center + treatment + baseline value + FEV1 before inhalation of salbutamol/albuterol + FEV1 30 min post inhalation of salbutamol/albuterol.|Baseline, Day 1|Safety Population includes all patients who received at least one dose of study drug.||milliseconds||Standard Error|Least Squares Mean
751488|NCT00558285|Secondary|Trough Forced Vital Capacity (FVC) at Day 1 and Day 14|Spirometry testing was performed in accordance with American Thoracic Society standards. Trough FVC was defined as the mean of two measurements at 23 hours 15 minutes and the 23 hours 45 minutes post dosing. Baseline was defined as the mean of the two values taken at 45 minutes and 15 minutes prior to dosing at day 1. Analysis of covariance: FVC parameter = center + treatment + baseline FVC + FEV1 before inhalation of salbutamol/albuterol + FEV1 30 min after inhalation of salbutamol/albuterol + error.|Day 1 and Day 14|Participants from the Intent-to-treat Population (all randomized patients) with data available at the given time-point. Any spirometric data collected less than six hours after rescue medication use was regarded as missing.||Liters||Standard Error|Least Squares Mean
751489|NCT00558285|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 1 and Day 14|Spirometry testing was performed in accordance with American Thoracic Society standards. Trough FEV1 was defined as the mean of two measurements at 23 hours 15 minutes and 23 hour 45 minutes post dosing. Baseline is defined as the mean of the two values taken at 45 minutes and 15 minutes prior to dosing at day 1. Least square means are based on the analysis of covariance: response variable=center + treatment + baseline value + Forced Expiratory Volume in one second (FEV1) before inhalation of salbutamol/albuterol + FEV1 30 minutes post inhalation of salbutamol/albuterol.|Day 1, Day 14|Intent-to-treat Population includes all randomized patients. Any spirometric data collected less than six hours after rescue medication use was regarded as missing.||Liters||Standard Error|Least Squares Mean
751490|NCT00558285|Secondary|Change From Baseline in Mean 24 Hour Heart Rate at Day 1|Heart rate was assessed by Holter monitoring and was measured over a 24 hour period at day 1. Heart rate was defined as the average value over the 24 hour monitoring period. The baseline measurement was the average heart rate taken from the 24 hour Holter monitoring period performed at screening or the last 24-hour period before taking the first dose of study drug. Least squares means are based on the analysis of covariance: 24 hours mean heart rate = center + treatment + baseline value + Forced Expiratory Volume in one second (FEV1) before inhalation of salbutamol/albuterol + FEV1 30 min after inhalation of salbutamol/albuterol + error.|Baseline, Day 1|Safety Population includes all patients who received at least one dose of study drug. Participants with less than 18 hours quality recording time data were excluded from this analysis.||beats per minute||Standard Error|Least Squares Mean
752798|NCT00572156|Secondary|Changes From Baseline (Day 1) in Serum Concentrations of Growth Hormone (GH)||At Baseline (Day 1), Year 1,2,3 and 4|Modified Intent-to-Treat (MITT) Population comprised all subjects who were randomized and had at least one post-baseline height measurement.||ng/mL||Standard Deviation|Mean
751491|NCT00558285|Primary|Change From Baseline in Mean 24 Hour Heart Rate at Day 14|Heart rate was assessed by Holter monitoring and was measured over a 24 hour period at day 14. Heart rate was defined as the average value over the 24 hour monitoring period. The baseline measurement was the average heart rate taken from the 24 hour Holter monitoring period performed at screening or the last 24-hour period before taking the first dose of study drug. Least square means are based on the analysis of covariance: 24 hours mean heart rate = center + treatment + baseline value + Forced Expiratory Volume in one second (FEV1) before inhalation of salbutamol/albuterol + FEV1 30 min post salbutamol/albuterol + error.|Baseline, Day 14|Safety Population includes all patients who received at least one dose of study drug. Participants with less than 18 hours quality recording time data were excluded from this analysis.||beats per minute||Standard Error|Least Squares Mean
751492|NCT00558363|Secondary|Number of Participants With Threshold Vital Signs at Baseline and Any Time Post-baseline|Threshold vital signs are defined as follows: < 80 mmHg or > 165 mmHg for systolic blood pressure; < 40 mmHg or > 105 mm Hg for diastolic blood pressure, < 40 beats per minute (bpm) or > 100 bpm for heart rate.|Baseline; up to 28 months|ITT Population. Participants not having a baseline as well as a post-baseline measurement of at least one vital sign parameter were excluded from this analysis (6 in placebo arm, 4 in dutasteride arm).||participants|||Number
751493|NCT00558363|Secondary|Number of Participants With a Digital Rectal Examination (DRE) Evaluation Changing From Normal/Diffusely Enlarged at Baseline to Focal Abnormality at Any Time Post-baseline|Participants underwent a digital rectal examination to evaluate for focal abnormality of the prostate.|Baseline; up to 28 months|ITT Population||participants|||Number
751494|NCT00558363|Secondary|Number of Participants With Nipple Tenderness (NT) at Baseline (BL) and Any Time Post-baseline|Participants underwent clinical examination of the breasts, to evaluate for nipple tenderness. Clinical significance of the results was determined by subjective judgment of the clinical personnel performing the examination.|Baseline; up to 28 months|ITT Population. Only those participants with NT at baseline or NT at any time post-baseline were measured for clinical significance.||participants|||Number
751495|NCT00558363|Secondary|Number of Participants With Palpable Breast Tissue (PBT) at Baseline (BL) and Any Time Post-baseline|Participants underwent clinical examination of the breasts, to evaluate for palpable breast tissue. Clinical significance of the results was determined by subjective judgment of the clinical personnel performing the examination.|Baseline; up to 28 months|ITT Population. Only those participants with PBT at baseline or PBT at any time post-baseline were measured for clinical significance.||participants|||Number
751496|NCT00558363|Secondary|Number of Participants With a Threshold Laboratory Value for Any Parameter at Baseline (BL) and Any Time Post-baseline|Threshold laboratory values are defined in terms of a multiplicative factor of the testing laboratory’s normal range, pre-specified in the analysis plan. A laboratory value that is above the upper limit factor multiplied by the upper limit of the normal range is considered a high threshold value. A laboratory value that is below the lower limit factor multiplied by the lower limit of the normal range is considered a low threshold value.|Baseline; up to 28 months|ITT Population. Participants not having a baseline as well as a post-baseline measurement of at least one laboratory parameter could not be evaluated and were hence excluded from this analysis (7 in placebo arm, 9 in dutasteride arm).||participants|||Number
751497|NCT00558363|Secondary|Number of Participants With a Shift From Normal at Baseline to at Least One Abnormal Laboratory Value for Any Parameter Any Time During the Study|A participant has a normal value for a laboratory parameter if the value is within the low and high range of normal provided by the laboratory. Each laboratory parameter is evaluated for shift from normal at baseline to abnormal any time post-baseline. A participant with any laboratory parameter showing this shift is counted. A participant is counted only once even if he had such a shift in more than one laboratory parameter or more than once among all post-baseline evaluations.|Baseline; up to 28 months|ITT Population. Participants not having any baseline measurements, or having a baseline but no post-baseline measurements of at least one of the same parameter could not be evaluated and were hence excluded from this analysis (7 in placebo arm, 9 in dutasteride arm).||participants|||Number
751498|NCT00558363|Secondary|Changes From Baseline in Disease-related Anxiety Measured by the Memorial Anxiety Scale for Prostate Cancer (MAX-PC)|MAX-PC is an 18-item, self-reported measure that evaluates prostate cancer-related anxiety. The score ranges from 0 to 54, and an increase in the score indicates a worsened anxiety level. Change from Baseline at Month X = Month X MAX-PC score - Baseline MAX-PC score. A missing post-baseline value is replaced by the last available post-baseline value (Last Observation Carried Forward(LOCF)). A general linear model controls for previous therapy, site cluster, and baseline MAX-PC score.|Baseline; Months 3, 6, 12, 18, and 24|ITT Population. Participants not having a baseline value or not having any post-baseline value could not be evaluated for this endpoint and were hence excluded from this analysis (3 in placebo arm, 4 in dutasteride arm). Participants were excluded from a specific visit analysis if the value for the visit (after LOCF application) was missing.||scores on a scale||Standard Error|Least Squares Mean
751499|NCT00558363|Secondary|Number of Participants With the Indicated Change in PSA Doubling Time (PSADT) From Baseline at Month 12, Month 24, and End-of-treatment (up to 28 Months)|Participants with improvement included those whose PSADT at a specified visit was positive but more than the baseline PSADT, whose PSA at the visit was the same as the baseline PSA, or whose PSA at the visit was less than the baseline PSA. Participants with worsening included those whose PSADT at the visit was positive but less than the baseline PSADT.|Baseline; Month 12, Month 24, End-of-Treatment (up to 28 months)|ITT Population. Participants having no baseline (BL) PSADT (due to incomplete PSA data or no rise in PSA at BL) or no post-BL measurement could not be evaluated and were hence excluded from this analysis (3 in placebo arm, 3 in dutasteride arm). Participants with missing PSA data at a specific visit were excluded from that visit’s analysis .||participants|||Number
751500|NCT00558363|Secondary|Percent Change in PSA From Nadir PSA at Months 12 and 24|Percent change from nadir PSA at Month X = 100*(Month X PSA – nadir PSA)/Nadir PSA. Nadir PSA was reported by the site as the lowest historical PSA value after the radical therapy. A nadir value below the detection level was captured as 0.0. The missing PSA value for scheduled visits could have been replaced by non-missing PSA values within 30 days after the clinic visit date. If such replacement was not possible, the latest non-missing post-baseline PSA before the scheduled visit was used for the scheduled visit PSA (Last Observation Carried Forward).|Baseline; Months 12 and 24|ITT Population. Participants not having any post-baseline PSA measurements could not be evaluated and were hence excluded from this analysis (3 in placebo arm, 1 in dutasteride arm).||percent change||Standard Deviation|Mean
751501|NCT00558363|Secondary|Change in PSA From Nadir PSA at Months 12 and 24|Change from nadir PSA at Month X = Month X PSA – nadir PSA. Nadir PSA was reported by the site as the lowest historical PSA value after the radical therapy. A nadir value below the detection level was captured as 0.0. The missing PSA value for scheduled visits could have been replaced by non-missing PSA values within 30 days after the clinic visit date. If such replacement was not possible, the latest non-missing post-baseline PSA before the scheduled visit was used for the scheduled visit PSA (Last Observation Carried Forward).|Baseline; Months 12 and 24|ITT Population. Participants not having any post-baseline PSA measurements could not be evaluated and were hence excluded from this analysis (3 in placebo arm, 1 in dutasteride arm).||ng/ml||Standard Deviation|Mean
751502|NCT00558363|Primary|Number of Participants With PSA Doubling From Baseline During Year 1|PSA doubling is defined as the first post-baseline PSA value (within treatment period, typically up to 12-month evaluations) that was at least twice as much as the baseline PSA value and was confirmed as such (at least 85% of two times the baseline PSA value) in the immediate subsequent PSA value if one is available.|up to 16 months|ITT Population. Participants not having any post-baseline PSA measurements could not be evaluated and were hence excluded from this analysis (3 in placebo arm, 1 in dutasteride arm).||participants|||Number
751503|NCT00558363|Primary|Time to PSA Doubling From Baseline (in Days) Within Year 1|Time to PSA doubling is defined as the number of days between the baseline date and the study day of the first post-baseline PSA evaluation date within Year 1 (Y1; within treatment period, typically up to 12-month evaluations) on which the PSA value was at least twice as much as the baseline PSA value, and the immediate subsequent value, if available, was at least 85% of two times the baseline value.|up to 16 months|ITT Population. Participants not having any post-baseline PSA measurements could not be evaluated and were hence excluded from this analysis (3 in placebo arm, 1 in dutasteride arm). Only participants with PSA doubling within Year 1 (50 in placebo, 15 in dutasteride) contributed to summary statistics.||days||Full Range|Median
751504|NCT00558363|Primary|Number of Participants With PSA Doubling From Baseline|PSA doubling is defined as the first post-baseline PSA value (within treatment period, typically up to 24-month evaluations) that was at least twice as much as the baseline PSA value and was confirmed as such (at least 85% of two times the baseline PSA value) in the immediate subsequent PSA value if one is available.|up to 28 months|ITT Population. Participants not having any post-baseline PSA measurements could not be evaluated and were hence excluded from this analysis (3 in placebo arm, 1 in dutasteride arm).||participants|||Number
751505|NCT00558363|Secondary|Percent Change in Total PSA From Baseline at Months 12 and 24|Percent change in PSA from baseline at Month X = 100*(Month X PSA - Baseline PSA)/Baseline PSA. The missing PSA value for scheduled visits could have been replaced by non-missing PSA values within 30 days after the clinic visit date. If such replacement was not possible, the latest non-missing post-baseline PSA before the scheduled visit was used for the scheduled visit PSA (Last Observation Carried Forward).|Baseline; Months 12 and 24|ITT Population. Participants not having any post-baseline PSA measurements could not be evaluated and were hence excluded from this analysis (3 in placebo arm, 1 in dutasteride arm).||percent change||Standard Deviation|Mean
751506|NCT00558363|Secondary|Change in Total PSA From Baseline at Months 12 and 24|Change in PSA from baseline at Month X = Month X PSA - Baseline PSA. The missing PSA value for scheduled visits could have been replaced by non-missing PSA values within 30 days after the clinic visit date. If such replacement was not possible, the latest non-missing post-baseline PSA before the scheduled visit was used for the scheduled visit PSA (Last Observation Carried Forward).|Baseline; Months 12 and 24|ITT Population. Participants not having any post-baseline PSA measurements could not be evaluated and were hence excluded from this analysis (3 in placebo arm, 1 in dutasteride arm).||nanograms/milliliter (ng/ml)||Standard Deviation|Mean
751507|NCT00558363|Secondary|Number of Participants With PSA Progression|A participant was designated as having a PSA progression if there existed a post-baseline PSA value (within treatment period, typically up to 24-month evaluations) that was (>10 ng/ml if radical prostatectomy or >20 ng/ml if primary radiotherapy) and PSA >=1.5 times the baseline PSA value), or 0<PSADT<=91 days, and all subsequent PSA values satisfied either of these criteria.|up to 28 months|ITT Population. Participants not having any post-baseline PSA measurements could not be evaluated and were hence excluded from this analysis (3 in placebo arm, 1 in dutasteride arm).||participants|||Number
751508|NCT00558363|Secondary|Time to PSA Progression (in Days)|A participant was designated as having PSA progression if there existed a post-baseline PSA value (within treatment period, typically up to 24-month evaluations) that was >10 ng/ml if radical prostatectomy or >20 ng/ml if primary radiotherapy and PSA >=1.5 times the baseline PSA value, or 0<PSADT<=91 days, and all subsequent PSA values satisfied these criteria. The study day for the first PSA qualifying for progression was used for time to PSA progression. If none of the PSA values qualified for PSA progression, time to PSA progression was censored at the last post-baseline PSA evaluation.|up to 28 months|ITT Population. Only those participants with PSA progression have been summarized.||days||Full Range|Median
751509|NCT00558363|Secondary|Number of Participants With a PSA Rise From Baseline|A participant was designated as having a PSA rise if there existed a post-baseline PSA value (within treatment period, typically up to 24-month evluations) that was >1.15 times the baseline PSA value, and all subsequent PSA values were >1.15 times the baseline PSA value.|up to 28 months|ITT Population. Participants not having any post-baseline PSA measurements could not be evaluated and were hence excluded from this analysis (3 in placebo arm, 1 in dutasteride arm).||participants|||Number
751510|NCT00558363|Secondary|Time to PSA Rise From Baseline (in Days)|A participant was designated as having a PSA rise if there existed a post-baseline PSA value (within treatment period, typically up to 24-month evaluations) that was >1.15 times the baseline PSA value, and all subsequent PSA values were >1.15 times the baseline PSA value. The study day for the first PSA evaluation that qualified for analysis of PSA rise was used for time to PSA rise. If none of the post-baseline PSA values qualified for analysis of PSA rise during the study, time to PSA rise was censored at the last post-baseline PSA evaluation.|up to 28 months|ITT Population. Only those participants with PSA rise have been summarized.||days||Full Range|Median
751525|NCT00558467|Secondary|Patient Global Impression at Week 4|Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).|baseline and Week 4|The Full Analysis Set with last observation carried forward (LOCF).||Number of Patients|||Number
751512|NCT00558363|Secondary|Number of Participants With Disease Progression|Disease progression is defined as the first occurrence of any of the following: PSADT<=91 days, PSA value is at least 50% more than baseline value (>20 ng/ml for primary radiotherapy group or >10 ng/ml for radical prostatectomy group), rescue treatment, cancer-positive biopsy, cancer-positive bone scan. If one of the PSA criteria is qualifying (within treatment period, typically up to 24-month evaluations), an immediate subsequent PSA, if available, must confirm either criterion (or at least 85% of the qualifying value).|up to 28 months|ITT Population. Participants not having any post-baseline PSA measurements could not be evaluated and were hence excluded from this analysis (3 in placebo arm, 1 in dutasteride arm).||participants|||Number
751513|NCT00558363|Secondary|Time to Disease Progression From Baseline (in Days)|Time to disease progression is defined as the number of days between baseline and the first occurrence of any of the following: PSA doubling time (PSADT)<=91 days, PSA value is at least 50% more than baseline value (>20 nanogram/milliliter [ng/ml] for primary radiotherapy group or >10 ng/ml for radical prostatectomy group), rescue treatment, cancer-positive biopsy, cancer-positive bone scan. (Confirmation of PSA criteria is required in an immediate subsequent PSA, if available, and PSA values for consideration are restricted to treatment period, typically up to 24-month evaluations.)|up to 28 months|ITT Population. Only those participants with disease progression have been summarized.||days||Full Range|Median
751514|NCT00558363|Primary|Time to Prostate-specific Antigen (PSA) Doubling From Baseline (in Days)|Time to PSA doubling is defined as the number of days between the baseline date and the study day of the first post-baseline PSA evaluation date (within treatment period, typically up to 24-month evaluations) on which the PSA value was at least twice as much as the baseline PSA value, and the immediate subsequent value, if available, was at least 85% of two times the baseline value. Participants who never achieved PSA doubling were censored at the last post-baseline, non-missing PSA evaluation.|up to 28 months|ITT Population: all participants randomized to study treatment. Participants not having any post-baseline PSA measurements could not be evaluated and were hence excluded from this analysis (3 in placebo arm; 1 in dutasteride arm). Only participants who experienced PSA doubling (82 in placebo, 41 in dutasteride) contributed to summary statistics.||days||Full Range|Median
751515|NCT00558428|Primary|Number of Patients With Oedema|Patients from the treated set who experienced at least one case of general oedema.|During randomised treatment period (8 weeks was the planned end of treatment, some of the measurements analysed as end of study can be at 4 weeks or at any point on randomised treatment)|The treated set (TS) consisted of all patients that took at least one dose of the double-blind treatment (n=1097)||patients|||Number
751516|NCT00558428|Secondary|Trough Seated Blood Pressure (BP) Normality Classes|"The number of patients who reach predefined BP categories:
Optimal - SBP<120 and DBP<80 mmHg
Normal - SBP<130 and DBP<85 mmHg
High-normal - SBP<140 DBP<90 mmHg
Stage 1 hypertension - SBP<160 and DBP<100
Stage 2 hypertension SBP>=160 and DBP>=100 mmHg"|End of study (8 weeks or last value on treatment)|Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward. The full analysis set included patients who had baseline and at least one post baseline trough measure of blood pressure||patients|||Number
751517|NCT00558428|Secondary|Trough Seated SBP Response|The number of patients who reach the target SBP of <140mmHg or had a reduction in SBP >= 15 mmHg|End of study (8 weeks or last value on treatment)|Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward. The full analysis set included patients who had baseline and at least one post baseline trough measure of blood pressure||patients|||Number
751518|NCT00558428|Secondary|Trough Seated SBP Control|The number of patients who reach the target SBP of <140mmHg|End of study (8 weeks or last value on treatment)|Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward. The full analysis set included patients who had baseline and at least one post baseline trough measure of blood pressure||patients|||Number
751519|NCT00558428|Secondary|Trough Seated DBP Response|The number of patients who reach the target DBP of <90mmHg or had a reduction in DBP >= 10mmHg|End of study (8 weeks or last value on treatment)|Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward. The full analysis set included patients who had baseline and at least one post baseline trough measure of blood pressure||patients|||Number
751520|NCT00558428|Secondary|Trough Seated Diastolic Blood Pressure Control|The number of patients who reach the target DBP of <90mmHg|End of study (8 weeks or last value on treatment)|Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward. The full analysis set included patients who had baseline and at least one post baseline trough measure of blood pressure||patients|||Number
751521|NCT00558428|Secondary|Change From Baseline in Trough Seated Systolic Blood Pressure (SBP)|Change from baseline to the end of study in trough SBP|End of study (8 weeks or last value on treatment)|Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward. The full analysis set included patients who had baseline and at least one post baseline trough measure of blood pressure||mmHg||Standard Error|Least Squares Mean
751522|NCT00558428|Primary|Change From Baseline in Trough Seated Diastolic Blood Pressure (DBP)|Change from baseline to the end of study in trough DBP|End of study (8 weeks or last value on treatment)|Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward. The full analysis set included patients who had baseline and at least one post baseline trough measure of blood pressure||mmHg||Standard Error|Least Squares Mean
751523|NCT00558467|Secondary|Clinically Significant Abnormalities in Vital Signs (Orthostatic Reaction and Pulse Rate), and Serum Chemistry.||baseline and Week 6|Full Analysis Set (FAS).||participants|||Number
751524|NCT00558467|Secondary|Patient Global Impression at Week 6|Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).|baseline and Week 6|The Full Analysis Set with last observation carried forward (LOCF).||Number of Patients|||Number
751526|NCT00558467|Secondary|Patient Global Impression at Week 3|Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).|baseline and Week 3|The Full Analysis Set with last observation carried forward (LOCF).||Number of Patients|||Number
751527|NCT00558467|Secondary|Patient Global Impression at Week 2|Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).|baseline and Week 2|The Full Analysis Set with last observation carried forward (LOCF).||Number of Patients|||Number
751528|NCT00558467|Secondary|Patient Global Impression at Week 1|Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).|baseline and Week 1|The Full Analysis Set with last observation carried forward (LOCF).||Number of Patients|||Number
751529|NCT00558467|Secondary|Clinical Global Impressions - Severity of Illness at Week 6|Assessment of the overall severity of illness on a scale ranging from 1 (not at all ill) to 7 (the most extremely ill patients). Improved, Unchanged and Worsened responses correspond to changes from baseline of: -2 or less, -1 to +1, and 2 or greater.|baseline and Week 6|The Full Analysis Set with last observation carried forward (LOCF).||Number of Patients|||Number
751530|NCT00558467|Secondary|Clinical Global Impressions - Severity of Illness at Week 4|Assessment of the overall severity of illness on a scale ranging from 1 (not at all ill) to 7 (the most extremely ill patients). Improved, Unchanged and Worsened responses correspond to changes from baseline of: -2 or less, -1 to +1, and 2 or greater.|baseline and Week 4|The Full Analysis Set with last observation carried forward (LOCF).||Number of Patients|||Number
751531|NCT00558467|Secondary|Clinical Global Impressions - Severity of Illness at Week 3|Assessment of the overall severity of illness on a scale ranging from 1 (not at all ill) to 7 (the most extremely ill patients). Improved, Unchanged and Worsened responses correspond to changes from baseline of: -2 or less, -1 to +1, and 2 or greater.|baseline and Week 3|The Full Analysis Set with last observation carried forward (LOCF).||Number of Patients|||Number
751532|NCT00558467|Secondary|Clinical Global Impressions - Severity of Illness at Week 2|Assessment of the overall severity of illness on a scale ranging from 1 (not at all ill) to 7 (the most extremely ill patients). Improved, Unchanged and Worsened responses correspond to changes from baseline of: -2 or less, -1 to +1, and 2 or greater.|baseline and Week 2|The Full Analysis Set with last observation carried forward (LOCF).||Number of Patients|||Number
751533|NCT00558467|Secondary|Clinical Global Impressions - Severity of Illness at Week 1|Assessment of the overall severity of illness on a scale ranging from 1 (not at all ill) to 7 (the most extremely ill patients). Improved, Unchanged and Worsened responses correspond to changes from baseline of: -2 or less, -1 to +1, and 2 or greater.|baseline and Week 1|The Full Analysis Set with last observation carried forward (LOCF).||Number of Patients|||Number
751534|NCT00558467|Secondary|Clinical Global Impressions - Improvement at Week 6|Overall improvement during the last week compared to baseline ranging from 1 (very much improved), 2 (much improved), to 7 (very much worse). Responder has 'very much' or 'much' improvement. Non responder has less improvement than 'much' improvement.|baseline and Week 6|The Full Analysis Set with last observation carried forward (LOCF).||Number of Patients|||Number
751535|NCT00558467|Secondary|Clinical Global Impressions - Improvement at Week 4|Overall improvement during the last week compared to baseline ranging from 1 (very much improved), 2 (much improved), to 7 (very much worse). Responder has 'very much' or 'much' improvement. Non responder has less improvement than 'much' improvement.|baseline and Week 4|The Full Analysis Set with last observation carried forward (LOCF).||Number of Patients|||Number
751536|NCT00558467|Secondary|Clinical Global Impressions - Improvement at Week 3|Overall improvement during the last week compared to baseline ranging from 1 (very much improved), 2 (much improved), to 7 (very much worse). Responder has 'very much' or 'much' improvement. Non responder has less improvement than 'much' improvement.|baseline and Week 3|The Full Analysis Set with last observation carried forward (LOCF).||Number of Patients|||Number
751537|NCT00558467|Secondary|Clinical Global Impressions - Improvement at Week 2|Overall improvement during the last week compared to baseline ranging from 1 (very much improved), 2 (much improved), to 7 (very much worse). Responder has 'very much' or 'much' improvement. Non responder has less improvement than 'much' improvement.|baseline and Week 2|The Full Analysis Set with last observation carried forward (LOCF).||Number of Patients|||Number
751538|NCT00558467|Secondary|Clinical Global Impressions - Improvement at 1 Week|Overall improvement during the last week compared to baseline ranging from 1 (very much improved), 2 (much improved), to 7 (very much worse). Responder has 'very much' or 'much' improvement. Non responder has less improvement than 'much' improvement.|baseline and Week 1|The Full Analysis Set with last observation carried forward (LOCF).||Number of Patients|||Number
751539|NCT00558467|Secondary|Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 4|Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe)|baseline 4 weeks|The Full Analysis Set was composed of patients that provided a baseline and a post-baseline assessment in Total Tic Score. A total of 62 patients are included in the Full Analysis Set, 20 placebo patients and 42 pramipexole patients.||score on a scale||Standard Deviation|Mean
751540|NCT00558467|Secondary|Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 3|Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe)|baseline and 3 weeks|The Full Analysis Set was composed of patients that provided a baseline and a post-baseline assessment in Total Tic Score. A total of 62 patients are included in the Full Analysis Set, 20 placebo patients and 42 pramipexole patients.||score on a scale||Standard Deviation|Mean
751541|NCT00558467|Secondary|Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 2|Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe)|baseline and 2 weeks|The Full Analysis Set was composed of patients that provided a baseline and a post-baseline assessment in Total Tic Score. A total of 62 patients are included in the Full Analysis Set, 20 placebo patients and 42 pramipexole patients.||score on a scale||Standard Deviation|Mean
751542|NCT00558467|Secondary|Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 1|Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe)|baseline 1 week|The Full Analysis Set was composed of patients that provided a baseline and a post-baseline assessment in Total Tic Score. A total of 62 patients are included in the Full Analysis Set, 20 placebo patients and 42 pramipexole patients.||score on a scale||Standard Deviation|Mean
751543|NCT00558467|Secondary|Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 6|Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe)|baseline and 6 weeks|The Full Analysis Set with last observation carried forward (LOCF).||score on a scale||Standard Error|Least Squares Mean
751544|NCT00558467|Secondary|Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 4|Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50|baseline and 4 weeks|The Full Analysis Set was composed of patients that provided a baseline and a post-baseline assessment in Total Tic Score. A total of 62 patients are included in the Full Analysis Set, 20 placebo patients and 42 pramipexole patients.||score on a scale||Standard Deviation|Mean
751545|NCT00558467|Secondary|Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 3|Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50|baseline and 3 weeks|The Full Analysis Set was composed of patients that provided a baseline and a post-baseline assessment in Total Tic Score. A total of 62 patients are included in the Full Analysis Set, 20 placebo patients and 42 pramipexole patients.||score on a scale||Standard Deviation|Mean
751546|NCT00558467|Secondary|Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 2|Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50|baseline and 2 weeks|The Full Analysis Set was composed of patients that provided a baseline and a post-baseline assessment in Total Tic Score. A total of 62 patients are included in the Full Analysis Set, 20 placebo patients and 42 pramipexole patients.||score on a scale||Standard Deviation|Mean
751547|NCT00558467|Secondary|Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 1|Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50|baseline 1 week|The Full Analysis Set was composed of patients that provided a baseline and a post-baseline assessment in Total Tic Score. A total of 62 patients are included in the Full Analysis Set, 20 placebo patients and 42 pramipexole patients.||score on a scale||Standard Deviation|Mean
751548|NCT00558467|Primary|Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale|"Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50.
Analysis was adjusted for baseline total tic score and age as linear covariates."|baseline 6 weeks|The Full Analysis Set (FAS) with last observation carried forward (LOCF).||score on a scale||Standard Error|Least Squares Mean
751549|NCT00558558|Primary|Change in Severity of Poor Appetite Following Treatment With Haelan (Fermented Soy Product)|Change in severity of poor appetite measured using a visual analog scale (VAS) of 0 to 100 mm (0 mm = best, 100 mm = worst) at week 4 +/- 5 days.|Baseline and Week 4 +/- 5 days|The participants were not eligible for analysis based on the primary outcome timeline.|||||
751550|NCT00558571|Secondary|HbA1c|change from baseline on day 28. Baseline is defined as day -1.|in the morning of days -1 and 28|PD analysis set||percentage of hemoglobin||Standard Deviation|Mean
751551|NCT00558571|Secondary|Fructosamine|change from baseline to days 14 and 18. Baseline is defined as day -1.|day -1 (baseline), 14 and 28|PD analysis set||µmol/L||Standard Deviation|Mean
751552|NCT00558571|Secondary|Glucagon AUEC0-5|Change from baseline (day -1) in AUEC0-5 on day 28.|0:00, 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day -1. 0:05 before drug administration and 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day 28.|Pharmacodynamic (PD) analysis set: All patients who receive at least one dose of study medication (active drug or placebo) and had some PD data were included in the pharmacodynamic analysis.||ng*h/L||Standard Deviation|Mean
751553|NCT00558571|Secondary|Glucagon Emax (Maximum Measured Effect)|Change from baseline (day -1) in Emax on day 28.|0:00, 2:30, 5:00, 7:00, 10:00, 12:00, 24:00 h after drug administration on day -1. 0:05 before drug administration and 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day 28.|PD analysis set||ng/L||Standard Deviation|Mean
751554|NCT00558571|Secondary|Fasting Insulin|Change from baseline to the days 1, 7, 14, 21 and 28. Baseline is defined as day -1.|in the morning of days -1( baseline), 1, 7, 14, 21 and 28|PD analysis set||µU/mL||Standard Deviation|Mean
751555|NCT00558571|Secondary|Insulin Emax (Maximum Measured Effect)|change in Emax from baseline on day 28. Baseline is defined as day -1|0:00, 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day -1. 0:05 before drug administration and 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day 28.|PD analysis set||µU/mL||Standard Deviation|Mean
751556|NCT00558571|Secondary|Insulin AUEC0-5|change in AUEC0-5 from baseline on day 28. Baseline is defined as day -1.|0:00, 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day -1. 0:05 before drug administration and 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day 28.|PD analysis set||µU*h/mL||Standard Deviation|Mean
751557|NCT00558571|Secondary|Mean Daily Glucose (MDG) Measured in Blood|change from baseline in MDG on the days 1, 7, 14, 21 and 27. Baseline is defined as day -2.|0:00, 2:30, 5:00, 7:00, 10:00, 12:00, 13:30, 24:00 h after drug administration on day -2. 0:05 h before drug administration and 2:30, 5:00, 7:00, 10:00, 12:00, 13:30, 24:00 h after drug administration on day 1, 7, 14, 21 and 27|PD analysis set||mg/dL||Standard Deviation|Mean
751558|NCT00558571|Secondary|Fasting Plasma Glucose (FPG)|fasting plasma glucose on day -1 (baseline) and change from baseline to day 28|in the morning of days -1 and 28|PD analysis set||mg/dL||Standard Deviation|Mean
751559|NCT00558571|Secondary|Ae0-24 of Glucose|Amount of glucose eliminated in urine over the time interval 0 to 24h on day -2, -1, 1, 27 and 28. (Urinary Glucose Excretion)|Day -2 and 27: -2 to 0, 0 to 5, 5 to 12 and 12 to 24h; Day -1 and 1: 0 to 5, 5 to 12 and 12 to 24; Day 28: 0 to 5, 5 to 12, 12 to 24, 24 to 36, 36 to 48 and 48 to 72h|PD analysis set||mg||Geometric Coefficient of Variation|Geometric Mean
751561|NCT00558571|Secondary|fe0-24 of Empagliflozin|Fraction of analyte eliminated in urine from time point 0 to 24h after first dose (fe0-24) and at steady state (fe0-24,ss)|0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 h after drug administration on day 1 and 28|PK analysis set for patients who have fe data at day 1 and day 28||percentage of Empagliflozin||Geometric Coefficient of Variation|Geometric Mean
751562|NCT00558571|Secondary|CL/F of Empaglifozin|apparent clearance of the analyte in plasma after first dose (CL/F) and at steady state (CL/F,ss)|0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 h after drug administration on day 1 and 28|PK analysis set||mL/min||Geometric Coefficient of Variation|Geometric Mean
751563|NCT00558571|Secondary|AUC0-∞ of Empagliflozin|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) and over a uniform dosing interval τ at steady state (AUCτ,ss)|0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 h after drug administration on day 1|PK analysis set||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
751564|NCT00558571|Secondary|t1/2 of Empagliflozin|terminal half-life of the analyte in plasma after first dose (Day 1), denoted by t1/2; and at steady state (Day 28), denoted by t1/2,ss.|0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 h after drug administration on day 1 and 28|PK analysis set||hours||Geometric Coefficient of Variation|Geometric Mean
751565|NCT00558571|Secondary|Tmax of Empagliflozin|time from last dosing to maximum concentration of the analyte in plasma after first dose (Day 1), denoted by tmax; and at steady state (Day 28), denoted by tmax,ss.|0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 h after drug administration on day 1 and 28|PK analysis set||hours||Full Range|Median
751566|NCT00558571|Secondary|Cmax of Empagliflozin|maximum concentration of the analyte in plasma after first dose (Cmax, Day 1 ) and at steady state over a uniform dosing interval (Cmax,ss, Day 28).|0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 hours(h) after drug administration on day 1 and 28|Pharmacokinetic (PK) analysis set: comprised all 62 patients who received Empagliflozin and had evaluable PK parameter data.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
751567|NCT00558571|Primary|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinanalysis and ECG|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinanalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.|from drug administration up to 6 weeks|treated set||participants|||Number
751568|NCT00558571|Primary|Number of Subjects With Drug Related Adverse Events|number of subjects with investigator-defined drug-related adverse events.|from drug administration up to 6 weeks|treated set: comprised all 78 patients who received at least one dose of study medication||participants|||Number
751569|NCT00558636|Secondary|Change From Baseline of Health-Related Quality of Life (HRQoL) Score Assessed at Treatment Cycle 7|HRQoL was assessed with the Functional Assessment of Cancer Therapy-Lung (FACT-L) questionnaire, a validated instrument for determining lung cancer HRQoL. The 36-item questionnaire includes 4 domains: Physical, functional, emotional, and social/family well-being, and a lung cancer-specific subscale. The FACT-L total score ranges from 1 to 136. Lower scores demonstrate impaired HRQoL.|Change from baseline of HRQoL score assessed (at treatment Cycle 7 [21 days per cycle]) up to 5 months after randomization of the first patient.|Of the 91 randomized subjects in the ITT population, 88 completed the FACT-L at baseline. Since more than half of the subjects received only 1 or 2 cycles before the trial was stopped, the number of subjects who completed the questionnaire after the first cycles was very low, making the results difficult to interpret.||Units on a scale||Standard Deviation|Mean
751570|NCT00558636|Secondary|Change From Baseline of Health-Related Quality of Life (HRQoL) Score Assessed at Treatment Cycle 3 and Cycle 5|HRQoL was assessed with the Functional Assessment of Cancer Therapy-Lung (FACT-L) questionnaire, a validated instrument for determining lung cancer HRQoL. The 36-item questionnaire includes 4 domains: Physical, functional, emotional, and social/family well-being, and a lung cancer-specific subscale. The FACT-L total score ranges from 1 to 136. Lower scores demonstrate impaired HRQoL.|Change from baseline of HRQoL score assessed (at treatment Cycle 3 and Cycles 5 [21 days per cycle]) up to 5 months after randomization of the first patient.|Of the 91 randomized subjects in the ITT population, 88 completed the FACT-L at baseline. Since more than half of the subjects received only 1 or 2 cycles before the trial was stopped, the number of subjects who completed the questionnaire after the first cycles was very low, making the results difficult to interpret.||units on a scale||Standard Deviation|Mean
751571|NCT00558636|Secondary|Change From Baseline of Lung Cancer Symptoms (LCS) Score Assessed at Each Treatment Cycle (21 Days Per Cycle) Starting With Cycle 2|The LCS is a validated instrument for determining treatment impact on lung symptoms. The LCS consists of 7 questions with 5 responses ranging from “not at all” to “very much”. The LCS total score ranges from 0 to 28. Lower scores reflect greater lung cancer symptoms.|Change from baseline of LCS score assessed at each treatment cycle starting with Cycle 2 (Cycles 2, 3, 4, 5, 6, 7; 21 days per cycle) up to 5 months after randomization of the first patient.|Of the 91 randomized subjects in the ITT population, 90 completed the LCS at baseline. Since more than half of the subjects received only 1 or 2 cycles before the trial was stopped, the response rate (number of evaluable subjects completing the questionnaire) decreased from cycle to cycle and makes the results hard to interpret.||units on a scale||Standard Deviation|Mean
751572|NCT00558636|Secondary|Duration of Response|Duration of response (PR or better) was defined as the time from the first documented objective PR or CR, whichever was noted earlier, to disease progression or death (if death occurred before progression was documented). Since only 4 subjects had a response, the duration of response was not calculated.|Time from first documented objective response (complete response or partial response) to disease progression or death, or to last tumor assessment if censored, up to 5 months after randomization of the first patient.|All subjects that showed a response. Since only 4 subjects had a response, the data were not analyzed.||days|||Number
751642|NCT00559585|Secondary|Double-blind Period: Minimum Observed Serum Concentration of Abatacept||Days 57, 85, 113, 120, 127, 134, 141, and 169|Participants who received at least 1 dose of study medication and from whom at least 1 pharmacokinetic (PK) sample was collected and reported (N). Only participants with adequate PK profiles were included in the summary statistics and statistical analysis (n).||µg/mL||Standard Deviation|Geometric Mean
751573|NCT00558636|Secondary|Best Tumor Response (Number of Responses Per Category) According to Response Evaluation Criteria in Solid Tumors (RECIST)|Complete response (CR): Disappearance of all target lesions (TL). Partial response (PR): At least 30% decrease in sum of the largest diameter (LD) of TLs, taking baseline sum as reference. Stable disease (SD): No change in tumor size. Progressive disease (PD): At least a 20% increase in the sum of the LD of TLs, taking as reference the smallest sum LD recorded since treatment started, or the appearance of 1 or more new lesions.|Best tumor response assessed every 6 weeks by investigator during treatment up to 5 months after randomization of the first patient.|All randomized subjects (the intent to treat (ITT) population) were included in the analysis.||Participants|||Number
751574|NCT00558636|Secondary|Overall Survival (OS)|"Overall survival is the number of days from the date of randomization to the date of death due to any cause. Subjects alive at the time of analysis were censored at their last date of follow-up. Since the study was terminated early and 89% of subjects' data were censored, only the number of subjects who Failed (died) or were Censored is reported, not the usual measure number of days."|Up to 5 months after randomization of the first patient|All randomized subjects (the intent to treat (ITT) population) were included in the analysis. Since 89% of subjects were censored, OS could not be calculated. The number of subjects who Failed (died) or were Censored are reported.||Participants|||Number
751575|NCT00558636|Primary|Progression Free Survival|"Progression free survival (PFS) is the time (days) from date of randomization to date of first observed disease progression (radiological or clinical, whichever was earlier) or death due to any cause, if death occurred before progression was documented. Since the study was terminated early and 89% of subjects' data were censored, only the number of PFS events (Failed [progressed or died before progression]) is reported, not the usual measure number of days."|Up to 5 months after randomization of the first patient|It was intended to include all randomized subjects (the intent to treat (ITT) population) in the analysis. Since 89% of subjects were censored, PFS could not be calculated. The number of subjects who Failed (progressed or died before progression) or were Censored are reported.||Participants|||Number
751576|NCT00558701|Primary|Time to Wound Healing|Time to 90% confluent reepitheliazation of donor site, as indicator of wound healing|20 days|||days||Full Range|Mean
751577|NCT00558753|Secondary|Knee Range of Motion (Active Flexion)||1-30 days|||Degrees||Standard Error|Least Squares Mean
751578|NCT00558753|Secondary|Neuropathic Pain (S-LANSS > 12)|Patients will be evaluated in blinded fashion for lower extremity Complex Regional Pain Syndrome(CRPS) at pre-op, 1, 3, and 6 months postsurgery based initially on telephone interviews. An S-LANSS score of 12 or more was an indication of chronic neuropathic pain. Patients with an Self-report version of the Leeds Assessment of Neuropathic Symptoms and Signs(S-LANSS) score of 12 or more at 6 mo came to the physician’s office for a standardized physical examination, which included the S-LANSS examination items (allodynia and hyperalgesia) directly assessed by the physician, plus a pinprick evaluation.|3 and 6 months post-surgery|||participants|||Number
751579|NCT00558753|Primary|Epidural Medication Consumption Rate|Epidural medication consumption was recorded for each 4-h interval from the completion of surgery to the time that the epidural was discontinued (same as the time to achieve hospital discharge criteria). Because the discontinuation time varied from patient to patient (as they achieved physical therapy criteria), the average hourly consumption (total analgesic used divided by the total infusion time) was used as the measure of epidural drug use.|36 h|Because of structural missing data, sample sizes are smaller than the samples size for the secondary measure.||mL/h||Standard Deviation|Mean
751580|NCT00558792|Primary|Validity (Sensitivity and Specificity), Off-Site Reader 3 - Specificity|For each technically adequate coronary artery, the readers assessed or excluded the presence of coronary artery stenoses. If more than one stenosis was present in a single vessel, the readers recorded the most significant stenosis. Based on a match or mismatch between computed tomographic angiography (CTA) and coronary angiography as assessed by the adjudicator, each vessel diagnosis by CTA was defined as true negative (TN), false positive (FP), false negative (FN), or true positive (TP) based on coronary angiography findings. Technical inadequacy by multi-detector CTA was counted as FN or FP depending on the diagnostic results from conventional angiography. The percentage (%) of specificity [TN/(TN+FP)] is presented.|Immediately post dose|Number of participants with significant disease (>50% stenosis)||Specificity (%)|Participants||Number
751581|NCT00558792|Primary|Validity (Sensitivity and Specificity), Off-Site Reader 3 - Sensitivity|For each technically adequate coronary artery, the readers assessed or excluded the presence of coronary artery stenoses. If more than one stenosis was present in a single vessel, the readers recorded the most significant stenosis. Based on a match or mismatch between computed tomographic angiography (CTA) and coronary angiography as assessed by the adjudicator, each vessel diagnosis by CTA was defined as true negative (TN), false positive (FP), false negative (FN), or true positive (TP) based on coronary angiography findings. Technical inadequacy by multi-detector CTA was counted as FN or FP depending on the diagnostic results from conventional angiography. The percentage (%) of sensitivity [TP/(TP+FN)] is presented.|Immediately post dose|Number of participants with significant disease (>50% stenosis)||Sensitivity (%)|Participants||Number
751582|NCT00558792|Primary|Validity (Sensitivity and Specificity), Off-Site Reader 2 - Specificity|For each technically adequate coronary artery, the readers assessed or excluded the presence of coronary artery stenoses. If more than one stenosis was present in a single vessel, the readers recorded the most significant stenosis. Based on a match or mismatch between computed tomographic angiography (CTA) and coronary angiography as assessed by the adjudicator, each vessel diagnosis by CTA was defined as true negative (TN), false positive (FP), false negative (FN), or true positive (TP) based on coronary angiography findings. Technical inadequacy by multi-detector CTA was counted as FN or FP depending on the diagnostic results from conventional angiography. The percentage (%) of specificity [TN/(TN+FP)] is presented.|Immediately post dose|Number of participants with significant disease (>50% stenosis)||Specificity (%)|Participants||Number
751607|NCT00559273|Secondary|Time to Hemoglobin Response|Time to Hb response is defined as the number of study days until the first occurrence of an Hb response. Participants without events were censored at the time of evaluation. Median and 95 percent (%) confidence interval (CI) were estimated using Kaplan-Meier Survival Analysis. Hb response was an observed increase in Hb >=1.0 g/dL from baseline and an Hb concentration >= 10.0 g/dL before the end of the study without RBC transfusion before response.|Baseline up to Week 28|ITT population.||days||95% Confidence Interval|Median
757540|NCT00608569|Secondary|CD8 Count at Follow-up Visits|CD8 cell count (median, inter-quartile range)|At week 4, 12, 24, 36, and 48|||cells/mm3||Inter-Quartile Range|Median
751583|NCT00558792|Primary|Validity (Sensitivity and Specificity), Off-Site Reader 2 - Sensitivity|For each technically adequate coronary artery, the readers assessed or excluded the presence of coronary artery stenoses. If more than one stenosis was present in a single vessel, the readers recorded the most significant stenosis. Based on a match or mismatch between computed tomographic angiography (CTA) and coronary angiography as assessed by the adjudicator, each vessel diagnosis by CTA was defined as true negative (TN), false positive (FP), false negative (FN), or true positive (TP) based on coronary angiography findings. Technical inadequacy by multi-detector CTA was counted as FN or FP depending on the diagnostic results from conventional angiography. The percentage (%) of sensitivity [TP/(TP+FN)] is presented.|Immediately post dose|Number of participants with significant disease (>50% stenosis)||Sensitivity (%)|Participants||Number
751584|NCT00558792|Primary|Validity (Sensitivity and Specificity), Off-Site Reader 1 - Specificity|For each technically adequate coronary artery, the readers assessed or excluded the presence of coronary artery stenoses. If more than one stenosis was present in a single vessel, the readers recorded the most significant stenosis. Based on a match or mismatch between computed tomographic angiography (CTA) and coronary angiography as assessed by the adjudicator, each vessel diagnosis by CTA was defined as true negative (TN), false positive (FP), false negative (FN), or true positive (TP) based on coronary angiography findings. Technical inadequacy by multi-detector CTA was counted as FN or FP depending on the diagnostic results from conventional angiography. The percentage (%) of specificity [TN/(TN+FP)] is presented.|Immediately post dose|Number of participants with significant disease (>50% stenosis)||Specificity (%)|Participants||Number
751585|NCT00558792|Primary|Validity (Sensitivity and Specificity), Off-Site Reader 1 - Sensitivity|For each technically adequate coronary artery, the readers assessed or excluded the presence of coronary artery stenoses. If more than one stenosis was present in a single vessel, the readers recorded the most significant stenosis. Based on a match or mismatch between computed tomographic angiography (CTA) and coronary angiography as assessed by the adjudicator, each vessel diagnosis by CTA was defined as true negative (TN), false positive (FP), false negative (FN), or true positive (TP) based on coronary angiography findings. Technical inadequacy by multi-detector CTA was counted as FN or FP depending on the diagnostic results from conventional angiography. The percentage (%) of sensitivity [TP/(TP+FN)] is presented.|Immediately post dose|Number of participants with significant disease (>50% stenosis)||Sensitivity (%)|Participants||Number
751586|NCT00558792|Primary|Contrast Density (CD) Measurements, Off-Site Reader 3|For this assessment, each off-site reader was to place regions of interest (ROIs) into the lumens of the mid-portion of the left main coronary artery (LM) (segment number 5), and into the mid-portion of segment number 1 of the right coronary artery (RCA). The mean Hounsfield Units levels and standard deviations (SD) for those 2 ROIs were to be recorded by the reader.|Immediately post dose|||Hounsfield Units||Standard Deviation|Mean
751587|NCT00558792|Primary|Contrast Density (CD) Measurements, Off-Site Reader 2|For this assessment, each off-site reader was to place regions of interest (ROIs) into the lumens of the mid-portion of the left main coronary artery (LM) (segment number 5), and into the mid-portion of segment number 1 of the right coronary artery (RCA). The mean Hounsfield Units levels and standard deviations (SD) for those 2 ROIs were to be recorded by the reader.|Immediately post dose|||Hounsfield Units||Standard Deviation|Mean
751588|NCT00558792|Primary|Contrast Density (CD) Measurements, Off-Site Reader 1|For this assessment, each off-site reader was to place regions of interest (ROIs) into the lumens of the mid-portion of the left main coronary artery (LM) (segment number 5), and into the mid-portion of segment number 1 of the right coronary artery (RCA). The mean Hounsfield Units levels and standard deviations (SD) for those 2 ROIs were to be recorded by the reader.|Immediately post dose|||Hounsfield Units||Standard Deviation|Mean
751589|NCT00558792|Secondary|Number of Participants Who Experienced Adverse Events With Incidence of 5% or Greater|Participants who received investigational product (iopamidol injection) and experienced an adverse event (AE). See Adverse Events module for further details.|up to 72 hours post dose|||Participants who Experienced AE(s)|||Number
751590|NCT00558792|Primary|Diagnostic Quality of Visualization of Coronary Arteries, Off-Site Reader 3|For all technically adequate coronary artery segments, each reader was to assess whether each segment was visualized to a quality that was adequate for accurate diagnosis of the presence and severity of stenosis. An adequate quality for the accurate diagnosis of the presence and severity of coronary artery stenosis was comprised of 2 basic features: 1) no more than mild blurring of the spatial distinction between the vessel wall and lumen, and 2) a readily visible distinction in image contrast between calcified plaque, enhanced vessel lumen, and uncalcified vessel wall or plaque.|Immediately post dose|||Segments Visualized Accurately|Participants||Number
751591|NCT00558792|Primary|Diagnostic Quality of Visualization of Coronary Arteries, Off-Site Reader 2|For all technically adequate coronary artery segments, each reader was to assess whether each segment was visualized to a quality that was adequate for accurate diagnosis of the presence and severity of stenosis. An adequate quality for the accurate diagnosis of the presence and severity of coronary artery stenosis was comprised of 2 basic features: 1) no more than mild blurring of the spatial distinction between the vessel wall and lumen, and 2) a readily visible distinction in image contrast between calcified plaque, enhanced vessel lumen, and uncalcified vessel wall or plaque.|Immediately post dose|||Segments Visualized Accurately|Participants||Number
751592|NCT00558792|Primary|Diagnostic Quality of Visualization of Coronary Arteries, Off-Site Reader 1|For all technically adequate coronary artery segments, each reader was to assess whether each segment was visualized to a quality that was adequate for accurate diagnosis of the presence and severity of stenosis. An adequate quality for the accurate diagnosis of the presence and severity of coronary artery stenosis was comprised of 2 basic features: 1) no more than mild blurring of the spatial distinction between the vessel wall and lumen, and 2) a readily visible distinction in image contrast between calcified plaque, enhanced vessel lumen, and uncalcified vessel wall or plaque.|Immediately post dose|||Segments Visualized Accurately|Participants||Number
751593|NCT00558831|Primary|Subject Reported Change From Baseline Scale|"-1=worse 0=unchanged
1=mild improvement
2=moderate improvement
3=clear"|baseline and 1 month|||Participants|||Number
751608|NCT00559273|Secondary|Hemoglobin (Hb) Concentration Over the Time|The hemoglobin concentration was measured in g/dL every 2 weeks and at final visit.|Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, and final visit (Week 29)|ITT population. Here, n=number of evaluable participants at specified time point, respectively for each group.||g/dL||Standard Deviation|Mean
751594|NCT00558870|Primary|Dose Escalation Index at Day 15 (+/- 3 Days)|Intended index period from baseline to Day 15 to determine whether the addition of low dose methadone to morphine (in the methadone group) has a lower dose escalation index as compared to the morphine alone (in the morphine group) at Day 15 (+/- 3 days). To determine whether the methadone group of individuals has a lower dose escalation index as compared to the morphine alone group: Participant dosages measured at baseline and daily until end of study (day 15), total daily dose of methadone converted to daily morphine equivalent daily dose for cancer pain and added to total daily morphine dosages. From these daily values, maximum dose recorded will be Opioid Maximum Dose (OMD). Opioid escalation index measured as described in Outcome 1 above (milligrams calculated by formula, (OMD-OSD)/days). Low index indicates achievement of adequate analgesia or appearance of uncontrollable side effects limiting upward titration over time.|Day 15 (+/- 3 days)|No analysis possible due to small participation numbers.|||||
751595|NCT00558870|Primary|Number of Participants With Objective Response (OR)|Objective response (OR) is defined as a dose escalation index <20 where Opioid escalation index measured in milligrams is calculated by the formula, (OMD-OSD)/days, OMD = Opioid maximum dose as expressed in equianalgesic dose of oral morphine in milligrams, OSD= Opioid starting dose at the time of referral to palliative care/ pain specialist for the treatment of cancer pain as expressed in equianalgesic dose of oral morphine in milligrams. A low index indicates the achievement of adequate analgesia or appearance of uncontrollable side effects limiting upward titration over time. OR used in determining whether the addition of low dose methadone to morphine (in the methadone group) has a lower dose escalation index as compared to the morphine alone (in the morphine group) at Day 15.|Day 15 (+/- 3 days)|There were no participants analyzed in each group for outcome variable; the study was terminated without completing any analysis because the sample size was too small to detect any differences between the groups.|||||
751596|NCT00558896|Secondary|Duration of Response|Duration of response was calculated from the documentation (date) of first response (CR, VGPR, or PR) until the date of progression or last follow-up in the subset of patients who responded. Kaplan Meier method was used to compute this outcome.|Duration of study (up to 5 years)|Participants who achieved a partial response(PR) or better were evaluable for this analysis.||months||95% Confidence Interval|Median
751597|NCT00558896|Secondary|Progression Free Survival (PFS)|"PFS was defined as the time from registration to progression or death due to any cause. PFS was analyzed using Kaplan Meier method.
Progression was defined as any one or more of the following:
25% increase in serum M-component (absolute increase >= 0.5g/dl)
25% increase in urine M-component (absolute increase >= 200mg/24hour
25% increase in the difference between involved and uninvolved Free Light Chain levels (absolute increase >= 10mg/dl)
25% increase in bone marrow plasma cell percentage (absolute increase of >=10%)
Definite development of new bone lesion or soft tissue plasmacytomas"|Duration of study (up to 5 years)|||months||95% Confidence Interval|Median
751598|NCT00558896|Primary|The Number of Confirmed Hematologic Responses (Complete, Partial, or Very Good Partial Response)|"Response that was confirmed on 2 consecutive evaluations
Complete Response(CR): Complete disappearance of M-protein from serum and urine on immunofixation, normalization of Free Light Chain (FLC) ratio and <5% plasma cells in bone marrow.
Very Good Partial Response(VGPR): >=90% reduction in serum M-component; Urine M-Component <100mg per 24hours; <=5% plasma cells in bone marrow.
Partial Response(PR): >=50% reduction in serum M-component and/or Urine M-Component >=90% reduction or <200mg per 24hours; or >=50% decrease in difference between involved and uninvolved FLC levels."|Duration of study (up to 3 years)|||participants|||Number
751599|NCT00559013|Primary|Number of Participants With Major Colorectal Related Adverse Events: Leak, Stricture and Hemorrhage.||Discharge and 1 Month post surgery|||Participants|||Number
751600|NCT00559104|Secondary|Short-term and Long-term Treatment-related Toxicities|Patient may be assessed for toxicities any time after transplant, up to death, last contact date, or end-of-study date.|Any time after transplant|per protocol||participants|||Number
751601|NCT00559104|Primary|Mortality|Event will be recorded if it occurs any time from the date of transplant until the end-of-study date, or the date of last contact, whichever comes first.|Assessed at date of death post-transplant|per protocol||participants|||Number
751602|NCT00559104|Primary|Progression|"Event will be recorded if it occurs any time post-transplant, until date of death, last recorded contact, or end-of-study; whichever comes first.
Below is reported Progression-free Survival: event is relapse or progression, or death."|Assessed at date of progression post-transplant|per protocol||participants|||Number
751603|NCT00559273|Secondary|Percentage of Participants Who Required Dose Adjustments to Achieve a Stabilized Response|The total number of dose adjustments needed to achieve stabilized response was calculated from Day 1 until the first 8-week time window in which response was achieved. A participant was defined as having achieved a stable Hb response, if at least 75% of the scheduled Hb values were between 10.0 g/dL and 12.0 g/dL and >=1.0 g/dL from baseline for any 8-week time period, regardless of the requirement for dose adjustment for Hb maintenance. Achievement of stable response was determined using a moving 8-week time window, moving forward by 14 days in each iteration starting at Day 15, searching to see if the following conditions were met: 1) At least 3 scheduled Hb values (75% of the scheduled Hb values) in any 8-week time window were >=1.0 g/dL from baseline (as calculated above) and within the range of 10.0 g/dL to 12.0 g/dL. 2) There were at least 3 recorded Hb values within the time window.|Baseline to Week 28|ITT population. Here, N=number of participants analyzed for this measure.||percentage of participants|||Number
751604|NCT00559273|Secondary|Percentage of Participants With Stable Hemoglobin Response|A participant was defined as having achieved a stable Hb response, if at least 75 percent (%) of the scheduled Hb values were between 10.0 g/dL and 12.0 g/dL and >=1.0 g/dL from baseline for any 8-week time period, regardless of the requirement for dose adjustment for Hb maintenance. Achievement of stable response was determined using a moving 8-week time window, moving forward by 14 days in each iteration starting at Day 15, searching to see if the following conditions were met: 1) At least 3 scheduled Hb values (75% of the scheduled Hb values) in any 8-week time window were >=1.0 g/dL from baseline (as calculated above) and within the range of 10.0 g/dL to 12.0 g/dL. 2). There were at least 3 recorded Hb values within the time window.|Baseline to Week 28|ITT population.||percentage of participants||95% Confidence Interval|Number
751605|NCT00559273|Secondary|Percentage of Participants Who Had at Least 1 Hemoglobin Value Exceeding 12.0 g/dL|Percentage of participants having at least one Hb value greater than (>) 12 g/dL during the first 8 weeks of the study was reported.|Baseline to Week 8|ITT population. Here, N=number of participants evaluable for this measure.||percentage of participants|||Number
751609|NCT00559273|Primary|Change in Hemoglobin (Hb) Concentration Between Baseline and Evaluation Period|A time adjusted average baseline Hb concentration was calculated using the trapezoid rule from all available Hb measurements taken during the baseline period. The average evaluation period Hb concentration for each individual was calculated using the same method, from all their available measurements taken during the 2 month evaluation period (Week 21 to 28). The change in Hb concentration between the baseline and evaluation period was calculated by subtracting the baseline Hb from the evaluation period Hb. All blood samples for Hb measurements were taken prior to study drug administration.|Baseline (measurements at Week -2, Week -1 and Day 1) and Evaluation Period (Week 22, Week 24, Week 26, Week 28)|ITT population. Here, N (number of participants analyzed)=participants evaluable for this measure. Missing data were imputed using last value carried forward.||g/dL||Standard Deviation|Mean
751610|NCT00559273|Primary|Percentage of Participants With Hemoglobin (Hb) Response|Hb response was an observed increase in Hb greater than or equal to (>=) 1.0 gram per deciliter (g/dL) from baseline and an Hb concentration >= 10.0 g/dL before the end of the study without red blood cells (RBC) transfusion before response.|Baseline up to Week 28|Intent-to-treat (ITT) population included all randomized participants. Participants were analyzed according to the study treatment assigned.||percentage of participants||95% Confidence Interval|Number
751611|NCT00559364|Secondary|Percentage of Stools Categorized as Per Consistency|Stool consistency was categorized as hard, formed/normal, soft and watery. Percentage of stools of a specific consistency for each patient was calculated as: (total number of stools of specific consistency during the completed days of the inpatient period/ total number of stools during the completed days of the inpatient period)*100. Mean percentage of stool categorized as per consistency for total patients was summarized.|Day 1 up to Day 4 or Day 5 in inpatient period of treatment phase|ITT population included all randomized patients.||percentage of stools||Standard Deviation|Mean
751612|NCT00559364|Secondary|Mean Daily Number of Stools|Mean daily number of stools of each patient was calculated from frequency of stools by the patient per day. Mean daily number of stools during the collection period (Day 1 to Day 4 or Day 5 in inpatient period of treatment phase) for total patients was summarized.|Day 1 up to Day 4 or Day 5 in inpatient period of treatment phase|ITT population included all randomized patients.||stools per day||Standard Deviation|Mean
751613|NCT00559364|Primary|Percent Coefficient of Fat Absorption (CFA)|Percent CFA was calculated as ([fat intake - fat excretion]/fat intake)*100, determined in the stools which was collected from Day 1 to Day 4 or Day 5 during the inpatient period of treatment phase. Mean percent (%) CFA was calculated for Day 1 to Day 4 or Day 5 in inpatient period of treatment phase.|Day 1 up to Day 4 or Day 5 in inpatient period of treatment phase|Intent-to-treat (ITT) population included all randomized patients. Missing values at treatment phase were imputed using the median (50th percentile) of all non-missing values within a treatment group.||percent CFA||Standard Deviation|Mean
751614|NCT00559377|Secondary|Response to XRT Using RECIST|Response for the XRT is evaluated by the radiation oncologists as per standard clinical protocols|time to disease progression or 2 years following first FMISO scan|PET/CT acquisition was obtained using non-diagnostic low dose CT attenuation scans at the time of PET/CT imaging that limited our ability to accurately measure tumor dimensions and due to lack of complete data, we were not able to fulfill this aim.|||||
751615|NCT00559377|Secondary|Relationship Between Ki67 and Regional FMISO Uptake in Tumor|The value of the biomarker Ki67 analyses relates primarily to validating the information content of FMISO images.|Up to 2 years|11 tissue samples with Ki67 values were compared to FMISO uptake.||percentage of staining||Standard Deviation|Mean
751616|NCT00559377|Secondary|Relationship Between Hypoxia-related IHC Biomarkers and Regional FMISO Uptake in Tumor|The value of the biomarker by IHC analyses relates primarily to validating the information content of FMISO images.|Up to 2 years|11 tissue samples with Hif1, VEGF, p53 and EGFR IHC values were compared to FMISO uptake.||units on a scale 0=low, 8=high||Full Range|Median
751617|NCT00559377|Primary|Disease-free Survival (DFS)|Evaluate the value of pre-treatment FMISO results (T:B and HV) for all patients to predict the disease free survival outcome variables.|Up to 2 years|Of the 13 patients analyzed for disease-free survival, 10 remained disease-free throughout the 2 year follow up. For 3 patients, we could determine overall survival, but could not confirm whether or not they were disease-free.||participants disease-free after 2 years|||Number
751618|NCT00559377|Primary|Overall Survival (OS)|Evaluate the value of pre-treatment FMISO results (T:B and HV) for all patients to predict the survival outcome variables.|For up to 2 years|1 patient has been lost to follow up for survival measures.||participants still alive after 2 years|||Number
751619|NCT00559507|Secondary|Median Time to Treatment Failure||From the start of treatment up to 4 weeks after completion of study treatment|||Days||Full Range|Median
751620|NCT00559507|Secondary|Overall Response Rate (CR and PR)|Overall Response rate is defined as the sum of the complete response rate and partial response rate. Response and progression was evaluated in this study using the Response Evaluation Criteria in Solid Tumors (RECIST) Target lesions: Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started|From start of treatment to 24 weeks after completion of study treatment|||participants|||Number
751621|NCT00559507|Primary|Disease Control Rate (DCR)|DCR defined as complete response (CR), partial response (PR), stable disease (SD) > 24 weeks. Simon’s two-stage optimal design was used to estimate the DCR of AZD0530 after 24 weeks of therapy since this design allowed for early termination of the study. Response and progression was evaluated in this study using the Response Evaluation Criteria in Solid Tumors (RECIST) Target lesions: Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started|After 24 weeks of study therapy|||participants|||Number
751622|NCT00559585|Secondary|Open-Label LT Period: Number of Participants With Clinically Significant Laboratory Abnormalities|Laboratory assessments were performed in the LT period at 12-week intervals and at a yearly visit and, for participants who withdrew from the study prematurely, 7 days after the last dose of SC abatacept. Abnormalities were determined to be clinically significant by the investigator.|End of ST Period (Day 169) to last dose plus 7 days, up to 5 years (September 2014)|All participants who entered the LT Period and received at least 1 dose of study drug during the LT Period.||participants|||Number
751623|NCT00559585|Secondary|Open-Label LT Period: Number of Participants With Clinically Significant Abnormalities in Vital Sign Measurements|Vital sign assessments were performed in the LT period at 12-week intervals and at a yearly visit (at 16-week intervals) and, for participants who withdrew from the study prematurely, 7 days after the last dose of SC abatacept. Vital signs included seated systolic blood pressure, seated diastolic blood pressure, temperature, and heart rate. Abnormalities were determined to be clinically significant by the investigator.|End of ST Period (Day 169) to last dose plus 7 days, up to 5 years (September 2014)|All participants who entered the LT Period and received at least 1 dose of study drug during the LT Period.||participants|||Number
751624|NCT00559585|Secondary|Open-Label LT Period: Number of Participants With AEs of Special Interest|AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs: all infections, serious infections, and opportunistic infections; autoimmune disorders; malignancies; system injection reactions, and local injection site reactions.|End of ST Period (Day 169) to last dose plus 85 days, up to 5 years (September 2014)|All participants who entered the LT Period and received at least 1 dose of study drug during the LT Period.||participants|||Number
751625|NCT00559585|Secondary|Open-Label LT Period: Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Treatment-related AEs, or AEs Leading to Discontinuation|AE=any new untoward medical event or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Treatment-related SAE=possibly, probably, or certainly related to study drug|End of ST Period (Day 169) to last dose plus 85 days, up to 5 years (September 2014)|All participants who entered the LT Period and received at least 1 dose of study drug during the LT Period.||participants|||Number
751626|NCT00559585|Primary|Anti-TNF Failure Sub-Study Double Blind Period : Number of Participants With Positive Anti-abatacept or Anti-Cytotoxic T Lymphocyte Antigen 4-T Cell (CTLA4-T) Response in Anti-TNF Failure Population|Serum samples from all treated adult participants with active rheumatoid arthritis who were from the Anti-TNF failure population were screened for the presence of drug-specific antibodies using Enzyme Linked Immunoabsorbant Assay (ELISA). The number of participants who had the presence of anti-abatacept antibodies or anti-CTLA-4 antibodies present in their serum are summarized.|Days 85, and 169 and postvisits on Days 28, 56, and 85|All randomized participants in the Anti-TNF Failure Sub-study who received at least 1 dose of study medication. n=Number of participants with at least 1 assessment available.||participants|||Number
751627|NCT00559585|Secondary|Open-Label LT Period: Number of Participants With HAQ-DI Response at Days 169, 729, 1261, 1821|The disability section of the full HAQ includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain divided by the number of domains answered. HAQ-DI overall score ranges from a minimum of 0 to a maximum of 3.0. HAQ response was defined as an improvement (reduction) from baseline (Day 1) of at least 0.3 units in the HAQ score.|Days 169, 729, 1261, 1821|All participants who entered the LT period, received at least 1 dose of study drug during the LT period, and had HAD-QI scores at baseline and at specified days were summarized.||participants|||Number
751628|NCT00559585|Secondary|Open-Label LT Period: Number of Participants Achieving DAS 28 Low Disease Activity (LDA) at Days 169, 729, 1261, 1821|"The DAS28 index measures disease activity in rheumatoid arthritis and is a composite derived from the number of swollen/tender joints, laboratory tests of inflammation (C-reactive protein measured in mg/L), and participant assessment of global health (by marking a visual analog scale 100 mm line from very good to very bad). A higher DAS28 score indicates worse control of disease. High disease activity is > 5.1, low disease activity is < 3.2 and remission is < 2.6."|Days 169, 729, 1261, 1821|All participants who entered the LT period and received at least 1 dose of study drug during the LT period were summarized.||participants|||Number
751629|NCT00559585|Secondary|Open-Label LT Period: Number of Participants Achieving DAS 28 Remission at Days 169, 729, 1261, 1821|"The DAS28 index measures disease activity in rheumatoid arthritis and is a composite derived from the number of swollen/tender joints, laboratory tests of inflammation (C-reactive protein measured in mg/L), and participant assessment of global health (by marking a visual analog scale 100 mm line from very good to very bad). A higher DAS28 score indicates worse control of disease. High disease activity is > 5.1, low disease activity is < 3.2 and remission is < 2.6."|Days 169, 729, 1261, 1821|All participants who entered the LT period and received at least 1 dose of study drug during the LT period were summarized.||participants|||Number
751630|NCT00559585|Secondary|Open-Label LT Period: Mean Change From Baseline in Disease Activity Score in 28 Joints (DAS28) Using C-reactive Protein (CRP) at Days 169, 729, 1261, 1821|"The DAS28 index measures disease activity in rheumatoid arthritis and is a composite derived from the number of swollen/tender joints, laboratory tests of inflammation (C-reactive protein measured in mg/L), and participant assessment of global health (by marking a visual analog scale 100 mm line from very good to very bad). A higher DAS28 score indicates worse control of disease. High disease activity is > 5.1, low disease activity is < 3.2 and remission is < 2.6. A clinically significant response= decrease in DAS28 score of >1.2 from baseline."|Days 169, 729, 1261, 1821|All participants who entered the LT period and received at least 1 dose of study drug during the LT period were summarized.||units on a scale||95% Confidence Interval|Mean
755300|NCT00593606|Primary|Change in Uric Acid|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||µmol/l||Standard Deviation|Mean
751631|NCT00559585|Secondary|Open-Label LT Period: Number of Participants Achieving ACR 50 and ACR 70 Responses at Days 169, 729, 1261, 1821|The ACR 50 definition of improvement is a 50% improvement from baseline in the number of tender and swollen joint counts, and a 50% improvement from baseline in 3 of the remaining 5 core set measures: participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function and acute phase reactant value (C-reactive protein). ACR 70 is defined similarly with 70% improvements from baseline for tender and swollen joint counts and 3 out of 5 core measures.|Days 169, 729, 1261, 1821|All participants who entered the LT period and received at least 1 dose of study drug during the LT period were summarized.||participants|||Number
751632|NCT00559585|Secondary|Open-Label LT Period: Number of Participants Achieving ACR 20 Response at Days 169, 729, 1261, and 1821|The ACR 20 definition of improvement is a 20% improvement from baseline in the number of tender and swollen joints, and a 20% improvement from baseline in 3 of the remaining 5 core set measures: participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function and acute phase reactant value (C-reactive protein).|Days 169, 729, 1261, 1821|All participants who entered the LT period and received at least 1 dose of study drug during the LT period were summarized.||participants|||Number
751633|NCT00559585|Secondary|Double-blind Period: Number of Participants Seroconverting by Day 169 According to Status (Negative or Positive) at Baseline|Rheumatoid factor (RF) is an autoantibody (antibody directed against an organism's own tissues) most relevant in rheumatoid arthritis. It is an antibody against the Fc portion of Immunoglobulin (Ig)G, which is itself an antibody. RF and IgG join to form immune complexes which contribute to the disease process.|Baseline to Day 169|All randomized participants who received at least 1 dose of study medication. n=Number of participants with at least 1 assessment available.||participants|||Number
751634|NCT00559585|Secondary|Double-blind Period: Number of Participants With Positive Anti-abatacept Responses Over Time by Electrochemiluminescence Immunoassay Among the First 10% of Participants Randomized|An electrochemiluminescence immunoassay screened sera for drug-specific antibodies, immunocompetition was used to identify specific anti-abatacept reactivity. CTLA4 and Possibly Ig category=reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; abatacept molecule). Ig and/or Junction (JNCT) category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a postbaseline titer higher than Baseline, or any postbaseline positivity if Baseline value was missing. Trt=treatment.|Days 85, and 169 and postvisits on Days 28, 56, and 85|All participants who received at least 1 dose of abatacept and had at least 1 immunogenicity result reported during the short-term period.||participants|||Number
751635|NCT00559585|Secondary|Double-blind Period: Time-matched Median Percent Change From Baseline in Levels of Serum C-reactive Protein Over the Short-term Period|C-reactive protein is an acute phase reactant protein that is a clinical marker for rheumatoid arthritis. Time-matched median percent change from baseline= (time-matched baseline value - Post-baseline value)/time-matched baseline value*100, where the time-matched baseline value represents the median baseline value for only that cohort of participants with measurements available at that visit.|Baseline to Days 15, 29, 57, 85, 113, 141, and 169|All randomized participants who received at least 1 dose of study medication. n=Number of participants with at least 1 assessment available.||percent change||Inter-Quartile Range|Median
751636|NCT00559585|Secondary|Double-blind Period: Number of Participants With Positive Anti-abatacept or Anti-Cytotoxic T Lymphocyte Antigen 4-T Cell (CTLA4-T) Responses Over Time by Enzyme Linked Immunoabsorbant Assay (ELISA)|Serum samples from all treated adult participants with active rheumatoid arthritis were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept (anti-ABA) or anti-CTLA4 antibody (anti-CTLA4).|Days 85, and 169 and postvisits on Days 28, 56, and 85|All randomized participants who received at least 1 dose of study medication. n=Number of participants with at least 1 assessment available.||participants|||Number
751637|NCT00559585|Secondary|Anti-TNF Failure Sub-study Double Blind Period: Area Under The Curve In A Dose Interval (AUC TAU) of Abatacept|Serum concentrations of abatacept were analyzed using a validated ELISA. AUC(TAU) was measured as μg*h/mL. Samples for AUC (TAU) were obtained on Days 113, 120, 127, 134, and 141.|Dosing Interval between Days 113 and 141 (TAU=28 days)|Participants in the sub-study who received at least 1 dose of study medication and who had adequate PK profiles for analysis||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
751638|NCT00559585|Secondary|Double-blind Period: Area Under The Curve In A Dose Interval (AUC TAU) of Abatacept||Dosing interval between Days 113 and 141 (TAU=28 days)|Participants who received at least 1 dose of study medication and who had adequate PK profiles for analysis||µg*h/mL||Standard Deviation|Geometric Mean
751639|NCT00559585|Secondary|Anti-TNF Failure Substudy Double Blind Period: Geometric Mean Maximum Observed Serum Concentration of Abatacept|Serum concentrations of abatacept were analyzed using a validated enzyme-linked immunosorbent assay (ELISA). Samples were obtained on Days 57, 85, 113, 120, 127, 134, 141, and 169. Cmax was measured in micrograms per milliliter (μg/mL).|End of infusion on Days 1 and 113 for IV infusion and in the dosing interval of Days 113 to 120 for subcutaneous|Participants in the Sub-study who received at least 1 dose of study medication and who had adequate PK profiles were analyzed||μg/mL||Geometric Coefficient of Variation|Geometric Mean
751640|NCT00559585|Secondary|Double-blind Period: Maximum Observed Serum Concentration of Abatacept||End of infusion on Days 1 and 113 for IV infusion and in the dosing interval of Days 113 to 120 for subcutaneous|Participants who received at least 1 dose of study medication and who had adequate PK profiles for analysis||µg/mL||Standard Deviation|Geometric Mean
751641|NCT00559585|Secondary|Anti-TNF Failure Sub-study Double-blind Period: Minimum Observed Serum Concentration (Cmin) of Abatacept|Serum concentrations of abatacept were analyzed using a validated ELISA. Steady-state trough observed concentration in serum (Cminss) was measured in μg/mL. Samples were obtained on Days 57, 85, 113, 120, 127, 134, 141, and 169.|Days 57, 85, 113, 120, 127, 134, 141, and 169 (ST Period)|Participants who received at least 1 dose of study medication and who had adequate PK profiles were analyzed. n= number of participants available at each specific time point.||μg/mL||Geometric Coefficient of Variation|Geometric Mean
751834|NCT00560794|Secondary|Clearance of Blinatumomab||Cycle 1 at predose and at 2, 6, and 12 hours after start of infusion then weekly until end of the cycle, and at 1, 2, 4, 6, 8, and 24 hours after stop of infusion.|Participants who received at least 1 infusion of blinatumomab with available pharmacokinetic data.||L/hr/m²||Standard Deviation|Mean
751643|NCT00559585|Secondary|Double-blind Period: Number of Participants With Electrolyte Laboratory Test Results Meeting the Criteria for Marked Abnormality|Marked abnormality criteria: Sodium: <0.95*LLN/>1.05*ULN, or if BL<LLN, use <0.95* BL or >ULN, or if BL>ULN, use>1.05* BL or <LLN; potassium: <0.9* LLN/>1.1*ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN, use>1.1* BL or <LLN; chlorine: <0.9*LLN/>1.1* ULN, or if BL<LLN, use <0.9*BL or >ULN, or if BL>ULN, use>1.1*BL or <LLN; calcium: <0.8* LLN/>1.2* ULN, or if BL<LLN, use <0.75*BL or >ULN, or if BL>ULN, use>1.25* BL or <LLN; phosphorous: <0.75* LLN/>1.25*ULN, or if BL<LLN, use 0.67*BL or >ULN, or if BL>ULN, use>1.33* BL or <LLN|Day 1 through end of short-term period (Day 169)|All randomized participants who received at least 1 dose of study medication. N=number of participants with assessments available.||participants|||Number
751644|NCT00559585|Secondary|Double-blind Period: Number of Participants With Liver Function Laboratory Test Results Meeting the Criteria for Marked Abnormality|Marked abnormality criteria: Alkaline phosphatase (ALP): >2*ULN, or if BL>ULN, use >3*BL; aspartate aminotransferase (AST): >3*ULN, or if BL>ULN, use >4*BL; alanine aminotransferase (ALT): >3*ULN, or if BL>ULN, use >4*BL; G-glutamyl transferase (GGT): >2* ULN, or if BL>ULN, use >3*BL; bilirubin: >2* ULN, or if BL>ULN, use >4*BL; blood urea nitrogen: >2* BL; creatinine: >1.5*BL|Day 1 through end of short-term period (Day 169)|All randomized participants who received at least 1 dose of study medication. n=Number of participants with assessments available.||participants|||Number
751645|NCT00559585|Secondary|Double-blind Period: Number of Participants With Hematology Laboratory Test Results Meeting the Criteria for Marked Abnormality|ULN=upper limit of normal; LLN=lower limit of normal; BL= baseline. Marked abnormality criteria: Hemoglobin: >3 g/dL decrease from BL; hematocrit: <0.75*BL; erythrocytes: <0.75*BL; platelets: <0.67*LLN/>1.5*ULN, or if BL<LLN, use <0.5*BL and <100,000 mm^3; leukocytes: <0.75*LLN/>1.25*ULN, or if BL<LLN use <0.8*BL or >ULN, or if BL>ULN, use >1.2*BL or <LLN; neutrophils+bands: <1.0*10^3 c/uL; eosinophils: >0.750*10^3 c/uL; basophils: >400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750*10^3 c/uL/>7.50*10^3 c/uL.|Day 1 through end of short-term period (Day 169)|All randomized participants who received at least 1 dose of study medication. n=Number of participants with assessments available.||participants|||Number
751646|NCT00559585|Secondary|Double-blind Period: Number of Participants With Clinically Significant Abnormalities in Vital Sign Measurements|Vital sign measurements were performed for participants before and after infusion/subcutaneous injection of study medication at each visit and included seated systolic blood pressure, seated diastolic blood pressure, temperature, and heart rate. Abnormalities were determined to be clinically significant by the investigator.|Day 1 through end of short-term period (Day 169)|All randomized participants who received at least 1 dose of study medication.||participants|||Number
751647|NCT00559585|Secondary|Double-blind Period: Number of Participants With AEs of Special Interest|AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs: all infections,serious infections,and opportunistic infections; autoimmune disorders; malignancies; acute infusional AEs (prespecified AEs occurring within 1 hr of start of infusion), peri-infusional AEs (prespecified AEs occurring within 24 hrs of the start of infusion), system injection reactions, and local injection site reactions|Day 1 up to 56 days post last dose in short- term period or first dose in the long -term period, whichever occurs first.|All randomized participants who received at least 1 dose of study medication.||participants|||Number
751648|NCT00559585|Secondary|Anti-TNF Failure Sub-study Double-blind Period: Number of Participants With SAEs, AEs Leading to Discontinuation or Who Died|AE=any new untoward medical event or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|Day 1 to 56 days after last dose in short-term or first dose in the long-term, whichever occurs first.|All randomized participants who received at least 1 dose of study medication.||participants|||Number
751649|NCT00559585|Secondary|Double-blind Period: Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Treatment-related AEs, or AEs Leading to Discontinuation|AE=any new untoward medical event or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Treatment-related SAE=possibly, probably, or certainly related to study drug|Day 1 to 56 days after last dose in short-term or first dose in the long-term, whichever occurs first.|All randomized participants who received at least 1 dose of study medication.||participants|||Number
751650|NCT00559585|Secondary|Double-blind Period: Number of Participants Achieving Clinically Meaningful HAQ-DI Response at Day 169|The disability section of the full HAQ-DI includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3=unable to do. Higher scores=greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ-DI response=an improvement of at least 0.3 units from baseline in HAQ-DI.|Day 169|All participants who received at least 1 dose of study medication at any time and had HAD-QI scores available||participants|||Number
751651|NCT00559585|Secondary|Double-blind Period: Adjusted Mean Change From Baseline to Day 169 in HAQ-DI|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain divided by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0.|Baseline to Day 169|All participants who received at least 1 dose of study medication at any time and had HAD-QI scores available.||units on a scale||Standard Error|Mean
751858|NCT00553735|Primary|Corneal Staining Score||18 months|No data were collected because participants withdrew themselves, failed to show for their appointments, or were lost to follow-up.|||||
751652|NCT00559585|Secondary|Double-blind Period: Mean Baseline Health Assessment Questionnaire Disability Index (HAQ-DI) for Participants With Assessments at Day 169|The disability section of the full HAQ-DI includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. Higher scores=greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered.|Day 169|All participants who received at least 1 dose of study medication at any time and had HAD-QI scores available.||units on a scale||Standard Deviation|Mean
751653|NCT00559585|Secondary|Double-blind Period: Number of Participants Achieving ACR 50 and ACR 70 Responses at Day 169|The ACR 50 definition of improvement is a 50% improvement from baseline in the number of tender and swollen joint counts, and a 50% improvement from baseline in 3 of the remaining 5 core set measures: participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function and acute phase reactant value (C-reactive protein). ACR 70 is defined similarly with 70% improvements from baseline for tender and swollen joint counts and 3 out of 5 core measures.|Day 169|PP population, defined as participants who are compliant with the study criteria.||participants|||Number
751654|NCT00559585|Primary|Double-blind Period: Number of Participants Achieving American College of Rheumatology (ACR) 20 Response at Day 169|The ACR 20 definition of improvement is a 20% improvement from baseline in the number of tender and swollen joints, and a 20% improvement from baseline in 3 of the remaining 5 core set measures: participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function and acute phase reactant value (C-reactive protein).|Day 169|Per protocol (PP) population, defined as participants who are compliant with the study criteria.||participants|||Number
751655|NCT00559637|Secondary|Total Number of Red Blood Cell (RBC) Transfusions|RBC transfusions could be given during the study, if medically necessary, i.e., in participants with severe anemia with distinct symptoms or signs of anemia (such as in participants with acute blood loss, with severe angina, or whose hemoglobin decreased to critical levels).|Baseline to Month 9|ITT population||number of transfusions|||Number
751656|NCT00559637|Secondary|Total Number of Dose Adjustments|A dose adjustment was defined as a change versus the preceding dose. It included dose increase, dose reduction and dose interruption. An interruption (no dose given) was always counted as a dose adjustment, regardless of whether or not at the previous time point a dose had been administered. After an interruption a change in the dose relative to the dose given before the interruption was counted as a dose adjustment.|Baseline until Month 8|ITT population||dose adjustments|||Number
751657|NCT00559637|Secondary|Time to Increase of Hemoglobin Value to Over 11 g/dL|The duration (number of months) until the hemoglobin value exceeded 11 g/dL for the first time was summarized for participants for whom at least one measured hemoglobin value exceeded 11 g/dL.|Baseline to Month 9|ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome.||months||Standard Deviation|Mean
751658|NCT00559637|Secondary|Duration of Hemoglobin Values in the Range of 11-13 g/dL|The duration of hemoglobin values staying within the range of 11-13 g/dL was defined as the number of (not necessarily consecutive) months with all corresponding hemoglobin values in the respective range. All months with missing hemoglobin values were counted as months where the hemoglobin value did not stay within the respective range.|Baseline to Month 9|ITT population||months||Standard Deviation|Mean
751659|NCT00559637|Primary|Change From Baseline in Hemoglobin Value to the Evaluation Phase|The change from the baseline hemoglobin value to the mean hemoglobin value of the evaluation phase was only calculated if both the baseline value and the mean of the evaluation phase (mean of Months 8 and 9) were available. In case of only one available hemoglobin value within the evaluation phase, that single value replaced the mean.|Baseline, evaluation phase (Months 8 and 9)|ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome.||g/dL||Standard Deviation|Mean
751660|NCT00559637|Secondary|Duration of Hemoglobin Values in the Range of 11-12 g/dL|The duration of hemoglobin values staying within the range of 11-12 g/dL was defined as the number of (not necessarily consecutive) months with all corresponding hemoglobin values in the respective range. All months with missing hemoglobin values were counted as months where the hemoglobin value did not stay within the respective range.|Baseline to Month 9|ITT population||months||Standard Deviation|Mean
751661|NCT00559637|Primary|Percentage of Participants With Both Hemoglobin Values of the Evaluation Phase in the Range of 11-13 g/dL|Participants with both hemoglobin values of the evaluation phase (Months 8 and 9, i.e., Study Days 200-260, values were at least 21 days apart) in the range of 11-13 g/dL were classified as responder. Participants who received transfusion of erythrocytes between Study Day 139 and 260, or with at least one value missing or outside the range were classified as non-responder for the hemoglobin-range concerned.|Evaluation phase (Months 8 and 9)|ITT population||percentage of participants||95% Confidence Interval|Number
751662|NCT00559637|Primary|Percentage of Participants With Both Hemoglobin Values of the Evaluation Phase in the Range of 11-12 Grams Per Deciliter (g/dL)|Participants with both hemoglobin values of the evaluation phase (Months 8 and 9, i.e., Study Days 200-260, values were at least 21 days apart) in the range of 11-12 g/dL were classified as responder. Participants who received transfusion of erythrocytes between Study Day 139 and 260, or with at least one value missing or outside the range were classified as non-responder for the hemoglobin-range concerned.|Evaluation phase (Months 8 and 9)|Intent to treat (ITT) population included all participants who received at least one dose of study medication with at least one hemoglobin value measured during treatment period.||percentage of participants||95% Confidence Interval|Number
751663|NCT00559754|Secondary|Percentage of Participants With pCR by RKISS1 Gene Expression|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. RKISS1 gene expression was defined as below the housekeeping reference level (>0), above the housekeeping reference level (<0), or equal to the housekeeping reference level (0).|After Week 24 (surgery)|Only those participants evaluated for the specified biomarker were included in the analysis.||percentage of participants|||Number
751664|NCT00559754|Secondary|Percentage of Participants With pCR by KISS1 Gene Expression|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. KISS1 gene expression was defined as below the housekeeping reference level (>0), above the housekeeping reference level (<0), or equal to the housekeeping reference level (0).|After Week 24 (surgery)|Only those participants evaluated for the specified biomarker were included in the analysis.||percentage of participants|||Number
751665|NCT00559754|Secondary|Percentage of Participants With pCR by Angiotensin II Receptor Type I (AGTR) Gene Expression|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. AGTR gene expression was defined as below the housekeeping reference level (>0), above the housekeeping reference level (<0), or equal to the housekeeping reference level (0).|After Week 24 (surgery)|Only those participants evaluated for the specified biomarker were included in the analysis.||percentage of participants|||Number
751666|NCT00559754|Secondary|Percentage of Participants With pCR by Phosphorylated MAP Kinase (pMAPK) Gene Expression|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. pMAPK gene expression was defined as below the housekeeping reference level (>0), above the housekeeping reference level (<0), or equal to the housekeeping reference level (0).|After Week 24 (surgery)|Only those participants evaluated for the specified biomarker were included in the analysis.||percentage of participants|||Number
751667|NCT00559754|Secondary|Percentage of Participants With pCR by ENOS Gene Expression|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. ENOS gene expression was defined as below the housekeeping reference level (>0), above the housekeeping reference level (<0), or equal to the housekeeping reference level (0).|After Week 24 (surgery)|Only those participants evaluated for the specified biomarker were included in the analysis.||percentage of participants|||Number
751668|NCT00559754|Secondary|Percentage of Participants With pCR by Insulin-Like Growth Factor (IGF) Gene Expression|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. IGF gene expression was defined as below the housekeeping reference level (>0), above the housekeeping reference level (<0), or equal to the housekeeping reference level (0).|After Week 24 (surgery)|Only those participants evaluated for the specified biomarker were included in the analysis.||percentage of participants|||Number
751669|NCT00559754|Secondary|Percentage of Participants With pCR by HIF Gene Expression|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. HIF gene expression was defined as below the housekeeping reference level (>0), above the housekeeping reference level (<0), or equal to the housekeeping reference level (0).|After Week 24 (surgery)|Only those participants evaluated for the specified biomarker were included in the analysis.||percentage of participants|||Number
751670|NCT00559754|Secondary|Percentage of Participants With pCR by Phosphorylated AKT (pAKT) Gene Expression|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. pAKT gene expression was defined as below the housekeeping reference level (>0), above the housekeeping reference level (<0), or equal to the housekeeping reference level (0).|After Week 24 (surgery)|Only those participants evaluated for the specified biomarker were included in the analysis.||percentage of participants|||Number
751671|NCT00559754|Secondary|Percentage of Participants With pCR by VEGFR Gene Expression|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. VEGFR gene expression was defined as below the housekeeping reference level (>0), above the housekeeping reference level (<0), or equal to the housekeeping reference level (0).|After Week 24 (surgery)|Only those participants evaluated for the specified biomarker were included in the analysis.||percentage of participants|||Number
751672|NCT00559754|Secondary|Percentage of Participants With pCR by Vascular Endothelial Growth Factor (VEGF) Gene Expression|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. VEGF gene expression was defined as below the housekeeping reference level (>0), above the housekeeping reference level (<0), or equal to the housekeeping reference level (0).|After Week 24 (surgery)|Only those participants evaluated for the specified biomarker were included in the analysis.||percentage of participants|||Number
751708|NCT00560235|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)|The dosing interval was 1 cycle (4 weeks) in this study.|Cycle 5: 1 hour post-infusion on Day 1|The PK analysis set included all enrolled participants who started treatment and who had sufficient samples to provide interpretable results; number of participants evaluated for measure.||milligram*hour per liter (mg*hr/L)||Geometric Coefficient of Variation|Geometric Mean
751673|NCT00559754|Secondary|Percentage of Participants With pCR by Angiotension Protein Expression|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. Angiotensin protein expression was defined as 0 (no expression), 1 (normal), 2 (augmented expression), or NE (not evaluated).|After Week 24 (surgery)|Only those participants evaluated for the specified biomarker were included in the analysis.||percentage of participants|||Number
751674|NCT00559754|Secondary|Percentage of Participants With pCR by Endothelial Nitric Oxide Synthase (ENOS) Protein Expression|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. ENOS protein expression was defined as 0 (no expression), 1 (normal), 2 (augmented expression), or NE (not evaluated).|After Week 24 (surgery)|Only those participants evaluated for the specified biomarker were included in the analysis.||percentage of participants|||Number
751675|NCT00559754|Secondary|Percentage of Participants With pCR by Hypoxia Inducible Factor (HIF) Protein Expression|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. HIF protein expression was defined as 0 (no expression), 1 (normal), 2 (augmented expression), or NE (not evaluated).|After Week 24 (surgery)|Only those participants evaluated for the specified biomarker were included in the analysis.||percentage of participants|||Number
751676|NCT00559754|Secondary|Percentage of Participants With pCR by VEGFR Protein Expression|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. VEGFR protein expression was defined as 0 (no expression), 1 (normal), 2 (augmented expression), or NE (not evaluated).|After Week 24 (surgery)|Only those participants evaluated for the specified biomarker were included in the analysis.||percentage of participants|||Number
751677|NCT00559754|Secondary|Percentage of Participants With pCR by Vascular Endothelial Growth Factor Receptor (VEGFR) Amplification|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. VEFGR amplification was defined as 1 (aneuploid), 2 (normal), 4 (amplification), or NE (not evaluated).|After Week 24 (surgery)|Only those participants evaluated for the specified biomarker were included in the analysis.||percentage of participants|||Number
751678|NCT00559754|Secondary|Percentage of Participants With pCR by KISS1 Protein Expression|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. KISS1 protein expression was defined as 0 (no expression), 1 (normal), 2 (augmented expression), or NE (not evaluated).|After Week 24 (surgery)|Only those participants evaluated for the specified biomarker were included in the analysis.||percentage of participants|||Number
751679|NCT00559754|Secondary|Percentage of Participants With pCR by Kisspeptin (KISS1) Amplification|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. KISS1 amplification was defined as 1 (aneuploid), 2 (normal), 4 (amplification), or NE (not evaluated).|After Week 24 (surgery)|Only those participants evaluated for the specified biomarker were included in the analysis.||percentage of participants|||Number
751680|NCT00559754|Secondary|Percentage of Participants With pCR by Proliferation of Ki67|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. Biomarker Ki67 proliferation was defined as low (less than [<]15% ) and high (≥15%).|After Week 24 (surgery)|Population evaluable for anatomopathological response with evaluable levels of the specified biomarker; data were missing for 2 participants.||percentage of participants|||Number
751681|NCT00559754|Secondary|Percentage of Participants With Breast-Conserving Surgery|Breast-conserving surgery was defined as lumpectomy + lymphadenectomy (LA), segmentectomy + LA, quadrantectomy + LA, or other (including sentinal node extirpation tumorectomy).|Week 24|ITT population; only those participants who underwent surgery were included in the analysis||percentage of participants|||Number
751682|NCT00559754|Secondary|Percentage of Participants With Objective Clinical Response|Overall clinical response is the best response obtained through physical examination and/or radiological tests after completion of chemotherapy cycles. The percentage of participants with objective response based on assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) and was categorized as clinical response (CR+PR) or clinical benefit (CR+PR+ no change [NC]). Per RECIST, CR was defined as disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR was defined as greater than or equal to (≥)30 percent (%) decrease under baseline of the sum of the longest diameter (LD) of all target lesions. No unequivocal progression of non-target disease. No new lesions. Complete and partial responses must have been confirmed no less than 4 weeks after the criteria for response were first met.|Within 28 days of enrollment, Weeks 12 and 24|ITT Population||percentage of participants||95% Confidence Interval|Number
751791|NCT00560508|Secondary|Responder Rate For Patient Global Impression of Improvement (PGI-I)|PGI-I scores ranging from '1' (very much better) to '7' (very much worse), PGI-I responder have scoring of 1 or 2 (at least much better)|baseline and after 12 weeks treatment|Full Analysis Set (FAS) with last observation carried forward (LOCF)||percentage of participants|||Number
751683|NCT00559754|Primary|Percentage of Participants With Pathological Complete Response (pCR)|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria: 1) the primary tumor was Grade 5 (no malignant cells identified at the location of the primary tumor (ductal carcinoma in situ may be present); 2) no involvement was identified in the lymph nodes; 3) the tumour size at evaluation of the surgical piece was 0 centimeters (cm); and 4) the pathological staging of the tumour from the surgical piece was pT0pN0pM0, the stage is not applicable (NA). It will only be considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes.|After Week 24 (surgery)|Population evaluable for anatomopathological response: participants who satisfied all inclusion criteria and none of the exclusion criteria, received at least 2 cycles of chemotherapy treatment, and were evaluated pathologically.||percentage of participants||95% Confidence Interval|Number
751684|NCT00559897|Primary|PET Response Rate||FLT PET scan will be done 6-8 days after the dose of zoledronic acid||||||
751685|NCT00559936|Primary|Ocular and Systemic Safety|The occurrence of ocular and systemic adverse events was closely monitored over the course of this study. Ocular adverse events were monitored through complete ocular examinations including visual acuity measurement, intraocular pressure measurement, biomicroscopy, and corneal fluorescein staining. Systemic adverse events were identified with physical examinations, patient questioning, and blood pressure measurements taken throughout the study period.|All study visits|Participants treated with investigational medication were analyzed.||participants|||Number
751686|NCT00559936|Primary|The Size and Extent of Corneal Neovascularization Will be Measured by Computerized Image Analysis of Corneal Photographs Taken Throughout the Study.|The efficacy of bevacizumab in the treatment of corneal NV was evaluated by comparing corneal photographs taken at baseline with corneal photographs taken at the follow-up visits. Percent change from baseline was measured.|Six Months|Participants who received investigational treatment were analyzed.||percent change since baseline||Standard Deviation|Mean
751687|NCT00559949|Secondary|Overall Survival (OS)|Overall Survival using the Kaplan-Meier method with associated confidence intervals. OS analysis was intended to be mostly exploratory and descriptive in nature.|Up to 2 years|All participants||months||95% Confidence Interval|Median
751688|NCT00559949|Secondary|Occurrence of Treatment Related Adverse Events|Number of participants with related adverse events, per category and Grade category. Toxicity assessed using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.|Up to 2 years|All participants||adverse events|||Number
751689|NCT00559949|Secondary|Median Progression-Free Survival (PFS)|PFS is defined as the duration of time from start of treatment to time of progression or death. Progression evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST). Progressive Disease (PD): 20% increase in the sum of appropriate diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline, as well as an absolute increase of at least 0.5 cm. Secondary end points include toxicity, progression free survival, and overall survival. Due to the small sample size and absence of high quality historic data for this disease, these analyses were planned to be mostly exploratory and descriptive in nature.|Up to 2 years|All participants||weeks||95% Confidence Interval|Median
751690|NCT00559949|Primary|Objective Response Rate (ORR)|ORR: Complete Response (CR) and Partial Response (PR) evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST). CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. A conservative estimate of the response rate of the best-studied agent in this disease, doxorubicin, is approximately 5%. Therefore, investigators will assume that selumetinib (AZD6244, NSC 741078) would be worth further pursuit if the response rate (CR+PR) were at least 20%.|Up to 2 years|All evaluable participants||Participants|||Count of Participants
751691|NCT00559962|Secondary|Absolute Change From Baseline in Percent Hepatic Fat|Absolute change from Baseline in percent hepatic fat|Baseline and 12 weeks on study drug|ITT||Percent of Hepatic Fat||Standard Deviation|Mean
751692|NCT00559962|Primary|Absolute Change From Baseline in Percent Hepatic Fat|Absolute change from Baseline in percent hepatic fat|Baseline and 12 weeks on study drug|ITT||Percent of Hepatic Fat||Standard Deviation|Mean
751693|NCT00559988|Secondary|Rates of All-cause Mortality, Stroke (Ischemic and Hemorrhagic, Disabling and Non-disabling, Cardioembolic and Non-cardioembolic), and Major Bleeding, as Well as the AF Burden, Quality of Life, and Mean Heart Rate Reduction.|Secondary endpoints will be evaluated in a hierachical closed test procedure. If at the termination of the study, the result for the primary endpoint is found to have reached statistical significance, then Secondary Endpoints will be tested in turn for statistical significance at a 0.05 significance level. If at any stage, however, a non-significant result is found, no further testing of remaining secondary endpoints for statistical analysis will occur.|3 years||||||
751694|NCT00559988|Primary|Composite Primary Endpoint: Kaplan-Meier Estimate of Patients Without a Stroke, Systemic Embolism, or Major Bleed|The primary endpoint is to demonstrate whether early detection of atrial arrhythmias based on BIOTRONIK Home Monitoring technology combined with a predefined anticoagulation plan in the Home Monitoring Guided OAC group is superior to the Physician-Directed OAC group reflecting conventional care and physician directed treatment of AF in terms of risk reduction of the primary composite endpoint including stroke, systemic embolism, and major bleeding events.|From date of enrollment until date of primary endpoint event, assessed up to study exit, with a mean treatment duration of 2.0 years|Intent to treat analysis of all enrolled subjects||percentage of participants-Kaplan Meier|||Number
751695|NCT00560066|Primary|Number of Subjects Who Reported At Least One Reactogenicity Sign After One Vaccination of TIV or cTIV|Safety was assessed as the number of all subjects who reported at least one sign of reactogenicity after one vaccination of egg-derived (TIV) or cell culture-derived (cTIV) influenza virus vaccine from Day 1 through Day 7 post-vaccination.|From Day 1 up to and including Day 7 post-vaccination|Analysis was performed on the safety dataset, i.e. all subjects in the exposed set who provided post-baseline safety data.||Subjects|||Number
751709|NCT00560235|Secondary|Plasma Concentration at End of Infusion (Cendinf)||Cycle 1 Day 2 and Cycle 5 Day 1|The PK analysis set included all enrolled participants who started treatment and who had sufficient samples to provide interpretable results; n=number of participants evaluable for this measure at specified time points for each arm group, respectively.||mg/L||Geometric Coefficient of Variation|Geometric Mean
751696|NCT00560066|Secondary|Geometric Mean Ratio of Subjects With Underlying Medical Conditions After One Vaccination of TIV or cTIV|Immunogenicity was measured as the geometric mean ratio (GMR), calculated as the ratio of postvaccination to prevaccination HI GMTs for each of the three strains, three weeks after one vaccination (Day 22) of TIV or cTIV. CHMP criteria is considered fulfilled for each of the three strains if the geometric mean increase GMR (Day 22/Day 1) in HI antibody titer is >2.5 (≥18 to ≤60 years) or >2.0 (≥61 Years).|Three weeks post-vaccination (Day 22)|Analysis was performed on the immunogenicity subset of adults and elderly with underlying medical conditions.||Ratio||95% Confidence Interval|Geometric Mean
751697|NCT00560066|Secondary|Geometric Mean Titers of Subjects With Underlying Medical Conditions After One Vaccination of TIV or cTIV|Immunogenicity was measured as HI geometric mean titers (GMTs) of subjects with underlying conditions, directed against each of three vaccine strains at baseline (Day 1) and three weeks after vaccination (Day 22) in adults (≥18 to ≤60 years) and elderly (≥61 years).|Before vaccination (Day 1) and three weeks after vaccination (Day 22)|Analysis was performed on the immunogenicity subset of adults and elderly with underlying medical conditions.||Titers||95% Confidence Interval|Geometric Mean
751698|NCT00560066|Secondary|Percentages Of Subjects Who Achieved Seroconversion Or Significant Increase In HI Titers After One Vaccination of TIV or cTIV|Seroconversion or significant increase in HI titer as per CHMP criteria for each of the three strains is defined as the percentage of subjects with a prevaccination HI titer <10 to a postvaccination titer ≥40; or in subjects with prevaccination HI titer ≥10, a ≥4-fold increase in postvaccination HI antibody titer. According to the CHMP criteria, the percentage of subjects achieving seroconversion/significant increase should be >40% (≥18 to ≤60 years) or >30% (≥61 years).|Three weeks post-vaccination (Day 22)|Analysis was performed on the immunogenicity subset of adults and elderly with underlying medical conditions.||Percentages of Subjects||95% Confidence Interval|Number
751699|NCT00560066|Secondary|Percentages Of Subjects With Underlying Medical Conditions Who Achieved Hemagglutination Inhibition (HI) Titer ≥40 After One Vaccination of TIV or cTIV|Immunogenicity was measured as the percentage of adults (≥18 to ≤60 years) and elderly (≥61 years) achieving HI titers ≥40 at baseline (Day 1) and three weeks (Day 22) after one vaccination of TIV or cTIV for each of three vaccine strains, evaluated using hemagglutination inhibition (HI) egg-derived antigen assay. This criterion is met according to European (CHMP) guideline if the percentage of subjects achieving HI titers ≥40 is >70% (≥18 to ≤60 years), or >60% (≥61 years).|Before vaccination (Day 1) and three weeks after vaccination (Day 22)|Analysis was performed on the immunogenicity subset of adults and elderly with underlying medical conditions (full analysis set [FAS]: all enrolled subjects who received a study vaccine and provided one evaluable serum sample before and after baseline)||Percentages of Subjects||95% Confidence Interval|Number
751700|NCT00560066|Secondary|Number of Adults and Elderly With Underlying Medical Conditions Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV or cTIV|Analysis was performed on a subset of safety population which included the adults (≥18 to ≤60 years) and elderly (≥61 years) with underlying medical conditions.|From Day 1 through Day 7 post-vaccination|Analysis was done on the subset of safety population which included the adults and elderly with underlying medical conditions.||Subjects|||Number
751701|NCT00560066|Secondary|Number of Healthy Adults and Elderly Who Reported Solicited Local and Systemic Adverse Events (AEs) After One Vaccination of TIV or cTIV|Analysis was performed on a subset of safety population which included the healthy adults (≥18 to ≤60 years) and elderly (≥61 years).|From Day 1 through Day 7 post-vaccination|Analysis was done on a subset of safety population (i.e. all subjects in the exposed population who provide postvaccination safety data) which included the healthy adults and elderly.||Subjects|||Number
751702|NCT00560105|Secondary|Change in CCQ Score|The COPD Clinical Questionnaire (CCQ) is an objective validated tool to assess COPD symptoms. CCQ was measured at the randomization visit and at the end of the study visit at week 8. The CCQ is scaled 1 to 5. Five indicating no symptoms.|8 weeks|A patient population included||units on a scale||Standard Deviation|Mean
751703|NCT00560105|Secondary|Quality of Life Questionnaire/Daily Diary|St. George's Respiratory Questionnaire (SGRQ) is a well validated, widely used health status questionnaire specific for COPD. Its minimum important difference (MID) is 4 units. Unit of measure: 0 to 100 (100 = more limitation)|8 weeks|All patient data included||units on a scale||Standard Deviation|Mean
751704|NCT00560105|Secondary|FEV1 - Baseline and Device Comparisons|Spirometric data was collected primarily to document safety of the interventions. Pre- and Post-bronchodilator spirometry was obtained at the randomization visit and at Week 8.|8 weeks|A data collected included||liter||Standard Deviation|Mean
751705|NCT00560105|Primary|Safety and Efficacy of the Lung Flute Versus the Acapella for the Treatment of COPD in Adults. Twenty-four (24) Hour Dry Sputum Weight|In order to test the overall treatment effect on dry sputum weight over the course of the study, mixed effects analysis were performed. These models allow us to account for the longitudinal nature of the data. We assumed that the observations collected within each patient were correlated; however, observations collected across patients were assumed to be independent. Dry sputum weights obtained prior to and at randomization were regarded as baseline measurements, while those obtained at week 1, 2, 4, 6 and 8 were examined for treatment effects.|8 weeks|All patient data included||g||Standard Deviation|Mean
751706|NCT00560235|Secondary|Number of Participants With Positive Anti-Drug Antibody (ADA) Titer|Number of participants with positive sample(s) in the ADA assay and in the neutralizing anti-drug antibodies (NAb) assay. An endpoint titer <6.64 corresponded to negative ADA category value.|Cycle 4 (predose on Day 1), 28 days after last dose (End-of-Treatment), and follow-up (approximately 150 days after last dose)|All enrolled participants with ESFT and who started treatment with figitumumab. None of the serum samples were positive for ADAs following repeated administration of figitumumab, as indicated by an endpoint titer of <6.64.||participants|||Number
751707|NCT00560235|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|AUClast is the area under the plasma concentration time-curve from zero to the last measured concentration.|Cycle 1 and Cycle 5: 1 hour post-infusion on Day 1|The PK analysis set included all enrolled participants who started treatment and who had sufficient samples to provide interpretable results; n=number of participants evaluable for this measure at specified time points for each arm group, respectively.||mg*hr/L||Geometric Coefficient of Variation|Geometric Mean
751859|NCT00553787|Primary|Percentage of Subjects With a Weight Loss of at Least 5% at Week 56 With LOCF||Baseline to 56 weeks|intent-to-treat last-observation-carried-forward (ITT-LOCF)||percentage of participants|||Number
751710|NCT00560235|Secondary|Minimum Observed Plasma Trough Concentration (Cmin)|Cmin is the concentration at the end of treatment cycle (next cycle predose).|Cycle 6: predose on Day 1|The PK analysis set included all enrolled participants who started treatment and who had sufficient samples to provide interpretable results; number of participants evaluated for measure.||mg/L||Geometric Coefficient of Variation|Geometric Mean
751711|NCT00560235|Secondary|Maximum Observed Plasma Concentration (Cmax)||Cycle 1 and Cycle 5: 1 hour post-infusion on Day 1|The pharmacokinetic (PK) analysis set included all enrolled participants who started treatment and who had sufficient samples to provide interpretable results; n=number of participants evaluable for this measure at specified time points for each arm group, respectively.||milligrams per liter (mg/L)||Geometric Coefficient of Variation|Geometric Mean
751712|NCT00560235|Secondary|Overall Survival (OS)|Time in months from enrollment to death. For participants who are alive, overall survival was censored at the last contact.|Baseline and every 2 cycles (8 weeks), until death or up to 6 cycles after date of enrollment|All enrolled participants with ESFT and who started treatment with figitumumab.||months||95% Confidence Interval|Median
751713|NCT00560235|Secondary|Progression-Free Survival (PFS)|PFS was the time in months from start date to date of first documentation of progression, death due to any cause or symptomatic deterioration (global deterioration of health status requiring discontinuation of treatment).|Baseline and every cycle (4 weeks), until progression or death|All enrolled participants with ESFT and who started treatment with figitumumab.||months||95% Confidence Interval|Median
751714|NCT00560235|Primary|Objective Response Rate (ORR)|Percentage of participants with objective response based on assessment of confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as complete disappearance of all target and non-target disease and no new lesions. PR was defined as ≥30% decrease under baseline of the sum of diameters of all target lesions.|Baseline and every cycle (4 weeks), for up to 6 cycles|All enrolled participants with Ewing's sarcoma family of tumors (ESFT) and who started treatment with figitumumab; number of evaluable participants at data cut-off.||percentage of participants||95% Confidence Interval|Number
751715|NCT00560313|Primary|Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination.|The number of subjects who reported solicited reactions after the administration of the Meningococcal B vaccine at a 0, 2, 6-month schedule and the administration of the Meningococcal A, C, W, and Y vaccine at month 7.|One month after vaccinations|The analysis was done on the per protocol population.||participants|||Number
751716|NCT00560313|Primary|Percentage of Participants With Serum Bactericidal Activity of the Meningococcal ACWY Vaccine at One Month After Vaccination|"Percentage of participants with serum bactericidal activity (SBA) of the Meningococcal ACWY vaccine at one month after vaccination against A, C, W-135 and Y strains. Bactericidal activity (% ≥ 1:4, i.e., percentage of subjects with BCA titer ≥ 1:4; % ≥ 1:8, i.e. percentage of subjects with BCA titer ≥ 1:8) against a panel of genetically distinct meningococcal B strains:
prior to the first vaccination
30 days following the first, second, prior to the third and 30 days after the third vaccination"|One month after vaccinations|The analysis was done on the per protocol population.||percentage||95% Confidence Interval|Number
751717|NCT00560313|Primary|Geometric Mean Titer (GMT) of the Meningococcal ACWY Vaccine at One Month After Vaccination.|Geometric mean titer (GMT) of the Meningococcal ACWY Vaccine at One Month After the Immunization against the A, C, W-135 and Y strains.|One month after vaccinations|The analysis was done on the per protocol population.||titer||95% Confidence Interval|Geometric Mean
751718|NCT00560313|Primary|Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination.|"Percentage of participants with serum bactericidal activity (SBA) of the Meningococcal ACWY vaccine at one month after vaccination against A, C, W-135 and Y strains. Bactericidal activity (% ≥ 1:4, i.e., percentage of subjects with BCA titer ≥ 1:4; % ≥ 1:8, i.e. percentage of subjects with BCA titer ≥ 1:8) against a panel of genetically distinct meningococcal B strains:
prior to the first vaccination
30 days following the first, second, prior to the third and 30 days after the third vaccination"|One month after vaccinations|The analysis was done on the per protocol population.||percentage||95% Confidence Interval|Number
751719|NCT00560313|Primary|Geometric Mean Titer of the Meningococcal B Vaccine Against the Different Strains at One Month After First, Second and Third Vaccination.|Geometric mean titers(GMT) and the respective confidence intervals measured after each vaccination against the three different meningococcal strains.|One month after vaccinations|The analysis was done on the per protocol population.||titer||95% Confidence Interval|Geometric Mean
751720|NCT00560352|Primary|MTD and Recommended MTD of Bortezomib in Combination With Dasatinib and Dexamethasone|MTD is defined as the dose level combination below the dose level that produces a dose-limiting toxicity in at least 2 out of 6 or fewer participants in that cohort. If MTD is not reached, the recommended dose is the maximum dose that the participants received.|Days 1 to 21|All participants who received at least 1 dose of dasatinib and/or bortezomib and/or dexamethasone||mg/m^2|||Number
751721|NCT00560352|Secondary|Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Drug-related Adverse Events (AEs) Leading to Discontinuation, AEs Leading to Discontinuation, AEs, and Drug-related AEs by Grade|An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=possibly, probably, or certainly related to or of unknown relationship to study treatment. Grade 3=severe; Grade 4=life-threatening.|Continuously from Day 1 until last day of study medication + 30 days (maximum reached: 10 months)|All participants who received at least 1 dose of dasatinib and/or bortezomib and/or dexamethasone.||Participants|||Number
751722|NCT00560352|Secondary|Progression-free Survival|Progression-free survival was defined as the time from start of treatment until progression or death, whichever occurred first. Participants were to be followed-up for 12 months following the last dose of dasatinib for progression and survival. PFS was analyzed for the all-treated population.|Day 1 to disease progression or death, whichever came first (maximum reached: 14 months)|All participants who received at least 1 dose of dasatinib and/or bortezomib and/or dexamethasone||Months||95% Confidence Interval|Median
751723|NCT00560352|Secondary|Duration of Response|Duration of response calculated for those with best response=CR (M-protein [MP] undetectable by immunofixation [IF], ≤5% plasma cells in bone marrow, no soft tissue plasmacytomas); VGPR (MP detectable by IF, or ≥90% drop in serum [S] MP and urine [U] MP<100 mg/24h); PR(≥50% drop in S MP and ≥90% drop in U MP or U protein <200 mg/24h, ≥50% drop in BL ST PC size); or MR (≥25% to <50% drop in S MP and ≥50% to <90% drop in U MP and ≥25% to <50% drop in BL ST PC). Duration of response calculated from day criteria for CR, VGPR, PR, and MR were met until progression or death, whichever came first.|First occurrence of response to disease progression or death, whichever occurred first (maximum reached: 12.2 months)|All response-evaluable participants who achieved a response.||Months|||Number
751724|NCT00560352|Secondary|Best Overall Tumor Response Rate (RR) As Assessed Using International Uniform Response Criteria for Multiple Myeloma and Criteria of the European Bone Marrow Transplant Registry|S=serum; U=urine; MP=M-protein; ST=soft tissue, PC=plasmacytomas; IF=immunofixation; BL=baseline. RR calculated on best response any time. CR=MP undetectable by IF, ≤5% plasma cells in bone marrow, and no ST PC. VGPR=MP detectable by IF, or ≥90% drop in S MP and U MP<100 mg/24h. PR= ≥50% drop in S MP and ≥90% drop in U MP or U protein <200 mg/24h, ≥50% drop in BL ST PC size. MR= ≥25% to <50% drop in S MP and ≥50% to <90% drop in U MP and ≥25% to <50% drop in BL ST PC. SD=Not CR, VGPR, PR, or MR. PD= ≥25% rise in S or U M-component; new/increased size of bone lesions, ST PC, or hypercalcemia.|Day 1 until last tumor assessment (maximum reached: 9 months)|All response-evaluable participants who received at least 1 dose of dasatinib and/or bortezomib and/or dexamethasone||Percentage of participants|||Number
751725|NCT00560352|Primary|Maximum Tolerated Dose (MTD) and Recommended MTD of Dasatinib in Combination With Bortezomib and Dexamethasone|MTD is defined as the dose level combination below the dose level that produces a dose-limiting toxicity in at least 2 out of 6 or fewer participants in that cohort. If MTD is not reached, the recommended MTD is the maximum dose that the participants received.|Days 1 to 21|All participants who received at least 1 dose of dasatinib and/or bortezomib and/or dexamethasone||mg QD|||Number
751726|NCT00560391|Primary|Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus|Grading as per NCI CTCAE Version 3.0 criteria. GR1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. Calcium (low): GR1: <LLN – 8.0 mg/dL, GR2: <8.0 – 7.0 mg/dL, GR3: <7.0 – 6.0 mg/dL, GR4: <6.0 mg/dL. Calcium (High): GR1: >ULN – 11.5 mg/dL, GR2: >11.5 – 12.5 mg/dL, GR3: >12.5 – 13.5 mg/dL, GR4: >13.5 mg/dL. Magnesium (Low): GR1: <LLN – 1.2 mg/dL, GR2: <1.2 – 0.9 mg/dL, GR3: <0.9 – 0.7 mg/dL, GR4: <0.7 mg/dL. Phosphorus (low): GR1: <LLN – 2.5 mg/dL, GR2: <2.5 – 2.0 mg/dL, GR3: <2.0 – 1.0 mg/dL, GR4: <1.0 mg/dL. BL=Baseline; PBL=post baseline.|Baseline (pretreatment); Cycles 1 and 2 (within 24 hours of Days 1, 4, 8, 11, 15, 18, 21, and 25); beyond Cycle 2 (within 24 hours of Days 1 and 15,off treatment visit ) (median duration of dasatinib treatment=5.2 mo [range 0 to 33 mo])|All treated participants, participants who received at least 1 dose of dasatinib.||participants|||Number
751727|NCT00560391|Secondary|Number of Participants With Minimal Response|Response criteria was based on The International Uniform Response Criteria for Multiple Myeloma (with a slight modification). Minimal Response was achieved when there was 25% to 49% reduction of serum M-Protein, 50% to 89% reduction in 24 hour urinary M-protein which still exceeded 200 mg/24 hour. If the serum and urine M-protein were unmeasurable, 25% to 49% reduction in plasma cells was required. In addition, if present at baseline, a 25% to 49% reduction in the size of soft tissue plasmacytomas was also required.|Baseline, at the end of the treatment period (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).|All treated participants, participants who received at least 1 dose of dasatinib.||participants|||Number
751728|NCT00560391|Secondary|Number of Participants With Partial Response|Partial response was achieved when there was ≥50% reduction of serum M-protein (Mpr)and reduction in 24 hour urinary Mpr by ≥90% or to <200 mg/24 hr. If the serum and urine Mpr were unmeasurable, a ≥50% decrease in the difference between involved and uninvolved free light chain (FLC) levels was required in place of the Mpr criteria. If serum, urine Mpr, and serum FLC assay were unmeasurable, ≥50% reduction in plasma cells was required in place of Mpr, provided baseline bone marrow plasma cell percentage was ≥30%; a ≥50% reduction in the size of soft tissue plasmacytomas was also required.|Baseline, at the end of the treatment period (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).|All treated participants, participants who received at least 1 dose of dasatinib.||participants|||Number
751729|NCT00560391|Primary|Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC)|Grading as per NCI CTCAE Version 3.0 criteria. GR1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. Aspartate aminotransferase (AST) and alanine aminotransferase(ALT): GR1=>ULN-2.5*ULN (upper limit of normal); GR2=>2.5-5.0*ULN; GR3=>5.0-20.0*ULN; GR4:>20.0*ULN; TB:GR1=>ULN-1.5*ULN, GR2=>1.5-3.0*ULN, GR3=>3-10*ULN, GR4=>10*ULN; SC: GR1=>ULN-1.5*ULN, GR2=>1.5-3.0*ULN, GR3=>3.0-6.0*ULN, GR4=>6.0*ULN. BL=Baseline; PBL=post baseline.|Baseline (pretreatment); Cycles 1 and 2 (within 24 hours of Days 1, 4, 8, 11, 15, 18, 21, and 25); beyond Cycle 2 (within 24 hours of Days 1 and 15,off treatment visit ) (median duration of dasatinib treatment=5.2 mo [range 0 to 33 mo])|All treated participants, participants who received at least 1 dose of dasatinib.||participants|||Number
751730|NCT00560391|Primary|Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia|As per NCI CTCAE Version 3.0 criteria. Grade (GR)1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. White blood cell (WBC):GR1=<LLN(lower limit of normal)-3.0*10^9/L; GR2=<3.0-2.0*10^9/L; GR3:<2.0-1.0*10^9/L; GR4:<1.0*10^9/L. LLN=lower limit of normal. Absolute Neutrophil Count (ANC): GR1=<LLN-1.5*10^9/L; GR2=<1.5-1.0*10^9/L; GR3:<1.0-0.5*10^9/L; GR4:<0.5*10^9/L. Hemoglobin: GR1=<LLN-10.0g/dL; GR2=<10.0-8.0g/dL; GR3:<8.0-6.5g/dL; GR4:<6.5g/dL. Platelets: GR1=<LLN-75.0*10^9/L; GR2=<75.0-50.0*10^9/L; GR3:<50.0-25.0*10^9/L; GR4:<25.0*10^9/L. BL=Baseline; PBL=post baseline.|Baseline (pretreatment); Cycles 1 and 2 (within 24 hours of Days 1, 4, 8, 11, 15, 18, 21, and 25); beyond Cycle 2 (within 24 hours of Days 1 and 15,off treatment visit ) (median duration of dasatinib treatment=5.2 mo [range 0 to 33 mo])|All treated participants, participants who received at least 1 dose of dasatinib.||participants|||Number
751790|NCT00560508|Secondary|Change From Baseline in UPDRS Part I Score|UPDRS Part I ranging from 0 (normal) to 16 (severe). UPDRS Part I measures Mentation, Behavior and Mood|baseline and after 12 weeks treatment|Full Analysis Set (FAS) with last observation carried forward (LOCF)||UPDRS scores on a scale||Standard Error|Least Squares Mean
751731|NCT00560391|Primary|Number of Participants Who Died, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation|AE: New untoward medical occurrence or worsening of a preexisting medical condition that does not have causal relationship with this treatment. SAE: Untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, drug dependency/abuse; life-threatening, an important medical event, a congenital anomaly/birth defect; requires inpatient hospitalization/prolongs existing hospitalization. Grade 1= Mild; Grade 2= Moderate; Grade 3= Severe; Grade 4 = Life-threatening or disabling.|Baseline (pretreatment), from the date of first dose until at least 30 days after the last dose of study drug (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).|All treated participants, participants who received at least 1 dose of dasatinib.||participants|||Number
751732|NCT00560391|Secondary|Number of Participants With Complete Response and Very Good Partial Response|Response criteria were based on The International Uniform Response Criteria for Multiple Myeloma (with a slight modification). Complete response was achieved when there was negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow. Very good partial response was achieved when serum and urine M-component was detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-component plus urine M-component < 100 mg per 24 hour.|Baseline, At the end of the treatment period (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).|All treated participants, participants who received at least 1 dose of dasatinib.||participants|||Number
751733|NCT00560391|Primary|Number of Participants in the Dose Escalation Phase Who Reached Maximum Tolerated Dose (MTD) of Dasatinib With Lenalidomide and Dexamethasone|The MTD is considered the last dose level combination tested just below the maximum administered dose (MAD) level combination and for which DLTs were observed in less than 33% of participants during the escalation and expansion phase. Please refer to outcome 2 for the complete definition of DLT. If the MTD was not reached at the highest dose administered as defined by protocol, the highest dose (dasatinib 140 mg QD + lenalidomide 25 mg QD) administered was selected for the dose expansion phase of the study.|From the date of first dose to end of treatment (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).|All treated participants, participants who received at least 1 dose of dasatinib. (Participants included from Cohort 5 are those involved in the dose escalation phase only.)||participants|||Number
751734|NCT00560391|Primary|Number of Participants With Dose-limiting Toxicity (DLT)|DLTs: At least possibly drug-related AEs occurring during the first cycle of treatment and are:GR4 neutropenia >5 days/neutropenic fever;platelet count <10000mm^3 on >1 occasion;GR4 fatigue,or 2-point decline in ECOG performance status;>=GR3 nausea,diarrhea,and vomiting despite medical intervention;Any other clinically significant non-hematologic toxicity of >=GR3 considered not related to underlying MM;Any GR3/4 laboratory abnormality requiring hospitalization;dose interruption of either dasatinib and/or lenalidomide for >15 days due to any toxicity related to treatment with the combination.|From the date of first dose until at least 30 days after the last dose of study drug (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).|All treated participants, participants who received at least 1 dose of dasatinib. (Participants included from Cohort 5 are those involved in the dose escalation phase only.)||participants|||Number
751735|NCT00560391|Primary|Recommended Phase II Dose (RP2D) of the Combination (Dasatinib + Lenalidomide + Dexamethasone)|The RP2D was based on the MTD which was defined as the maximum combined dose producing dose limiting toxicity (DLT) in < 33% of participants treated at the individual dose levels in the combination. The MTD is considered the last dose level combination tested just below the maximum administered dose (MAD) level combination and for which DLTs were observed in less than or equal to 33% of participants during the escalation and expansion phase. If MTD was not reached Please refer to Outcome Measure 2 for the complete definition of DLT.|From the date of first dose to end of treatment (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).|All treated participants, participants who received at least 1 dose of dasatinib.||mg|||Number
751736|NCT00560404|Secondary|Number of Participants With Abnormal Changes in Vital Signs From Baseline to Week 40|Vital signs included blood pressure, pulse rate and body weight.|From Baseline to Week 40|The analysis was performed on safety population.||participants|||Number
751737|NCT00560404|Secondary|Number of Participants With Abnormal Changes in ECG From Baseline to Week 40|Twelve-lead ECG was performed.|From Baseline to Week 40|The analysis was performed on Safety population.||participants|||Number
751738|NCT00560404|Secondary|Number of Participants With Adverse Events and Serious Adverse Events|An adverse event (AE) was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Number of participants with at least one AE and SAE were reported.|Up to Week 40|The analysis was performed on Safety Population.||participants|||Number
751739|NCT00560404|Secondary|Mean Values of Aspartate Transaminase and Alkaline Phosphatase at Baseline and Week 36|The mean values of aspartate transaminase (AST) and alkaline phosphatase (ALP) levels in serum for each participant were estimated throughout the study. Summary data of mean values of Potassium and alkaline phosphatase level in serum at Baseline and Week 36 are presented.|Baseline and Week 36|The analysis was performed on safety population. The “n” represents the number of participants analyzed at a specified time point..||International units/Liter||Standard Deviation|Mean
751740|NCT00560404|Secondary|Mean Values of Transferrin Saturation at Baseline and Week 36|The mean values of transferrin saturation (TS) for each participant were estimated throughout the study. Summary data of mean values of TS at Baseline and Week 36 are presented.|Baseline and Week 36|The analysis was performed on safety population. The “n” represents the number of participants analyzed at a specified time point.||percentage||Standard Deviation|Mean
751741|NCT00560404|Secondary|Mean Values of Ferritin Concentration at Baseline and Week 36|Mean values of ferritin concentration for each participant throughout the study was estimated. Summary data of mean values of ferritin concentration at Baseline and Week 36 are presented.|Baseline and Week 36|The analysis was performed on safety population. The “n” represents the number of participants analyzed at a specified time point.||micrograms per liter||Standard Deviation|Mean
751742|NCT00560404|Secondary|Mean Values of Albumin and Transferrin Concentration at Baseline and Week 36|The mean values of albumin and transferrin concentration for each participant throughout the study was estimated. Summary data of mean values of albumin and transferrin concentration at baseline and week 36 are presented.|Baseline and Week 36|The analysis was performed on safety population. The “n” represents the number of participants analyzed at a specified time point.||gram/litre||Standard Deviation|Mean
751743|NCT00560404|Secondary|Mean Values of Creatinine, Potassium, Phosphate, Parathyroid Hormone , Iron and Total Iron Binding Capacity Parameters at Baseline and Week 36|Mean values of laboratory parameters: creatinine, potassium, phosphate, parathyroid hormone (PTH), iron and total iron binding capacity (TIBC) for each participant were estimated throughout the study. Summary data of mean values of laboratory parameters are presented at Baseline and Week 36.|Baseline and Week 36|The analysis was performed on safety population. The “n” represents the number of participants analyzed at a specified time point.||micromoles per liter||Standard Deviation|Mean
751744|NCT00560404|Secondary|Mean Values of Leukocytes and Platelets Count at Baseline and Week 36|The mean values of laboratory parameters: leukocytes and platelets count for each participant was estimated throughout the study. Summary data of mean values of leukocytes and platelets count at Baseline and Week 36 are presented.|Baseline and Week 36|The analysis was performed on safety population. The “n” represents the number of participants analyzed at a specified time point.||10^9/Litre||Standard Deviation|Mean
751745|NCT00560404|Secondary|Mean Values of Mean Corpuscular Volume at Baseline and Week 36|Mean corpuscular volume (MCV) is the average volume of red cells. The mean MCV concentration for each participant throughout the study was estimated. Summary data of mean values of MCV concentration at Baseline and Week 36 are presented.|Baseline and Week 36|The analysis was performed on safety population. The “n” represents the number of participants analyzed at a specified time point.||femtoliters||Standard Deviation|Mean
751746|NCT00560404|Secondary|Mean Values of Hematocrit at Baseline and Week 36|Hematocrit is the volume percentage of red blood cells in blood. The mean hematocrit for each participant was estimated throughout the study. Summary data of mean values of Hb at Baseline and Week 36 are presented.|Baseline and Week 36|The analysis was performed on safety population. The “n” represents the number of participants analyzed at a specified time point.||fraction||Standard Deviation|Mean
751747|NCT00560404|Secondary|Mean Values of Hemoglobin Concentration at Baseline and Week 36|The mean Hb concentration for each participant throughout the study was estimated. Summary data of mean values of Hb concentration at Baseline and Week 36 are presented.|Baseline and Week 36|The analysis was performed on safety population. The “n” represents the number of participants analyzed at a specified time point.||g/dL||Standard Deviation|Mean
751748|NCT00560404|Secondary|Number of Participants Received Red Blood Cells Transfusions|The number of participants who received at least 1 red blood cell (RBC) transfusion (packed RBC or whole blood) during the study was reported. For this study, blood transfusion was reported during the titration period. No transfusion occurred in the EEP.|Up to Week 28|The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not||participants|||Number
751749|NCT00560404|Secondary|Number of Participants Who Required Dose Adjustments During the Efficacy Evaluation Period|The number of participants who required dose adjustments of C.E.R.A and epoetin alpha were reported during the Efficacy Evaluation Period (EEP). The EEP was from Week 29 to Week 36.|EEP (Weeks 29 to 36)|The analysis was performed on ITT population.||participants|||Number
751750|NCT00560404|Secondary|Number of Participants Who Required Dose Adjustments During the Dose Titration Period|The number of participants who required dose adjustments of C.E.R.A and epoetin alpha were reported during the Dose Titration Period (DTP). The DTP was from Week 0 to Week 28.|DTP (Weeks 0 to 28)|The analysis was performed on ITT population.||participants|||Number
751751|NCT00560404|Secondary|Mean Time Spent in Hemoglobin Range of 10.5 - 12.5 Gram/Decilitre During the Efficacy Evaluation Period|Mean time to maintain Hb in the range of 10.5-12.5 g/dL during EEP is presented.|EEP (Week 29 to Week 36)|The analysis was performed on ITT population.||days||Standard Deviation|Mean
751752|NCT00560404|Secondary|Percentage of Participants Maintaining Individual Hemoglobin Concentration Within the Range of 10.5 - 12.5 Gram/Decilitre Throughout the Efficacy Evaluation Period|Percentage of participants maintaining individual Hb concentration within the Hb range 10.5 - 12.5 g/dL were reported during EEP. The EEP was from Week 29 to Week 36 of the study period.|EEP (Weeks 29 to 36)|The analysis was performed on ITT population.||percentage of participants|||Number
751753|NCT00560404|Secondary|Mean Change From Baseline in Hemoglobin Concentration Between Baseline and at the Efficacy Evaluation Period|The Baseline (Safety Verification Period) was from Week - 4 to Week -1.|Baseline (Weeks -4 to 0) and at EEP (Weeks 29 to 36)|The analysis was performed on ITT population.||g/dL||Standard Deviation|Mean
751754|NCT00560404|Primary|Percentage of Participants Maintaining Their Mean Hemoglobin Concentration Within Plus or Minus 1 Gram/Deciliter of Their Reference Hemoglobin and Between the Target Range During Efficacy Evaluation Period|The target hemoglobin (Hb) range was defined as Hb concentration (gram/deciliter [g/dL]) between 10.5 and 12.5 g/dL during the efficacy evaluation period (EEP). EEP was from Week 29 to Week 36.|EEP (Week 29 to Week 36)|Per-protocol population included participants who received at least one dose of C.E.R.A. and had data of at least one follow-up variable excluding those participants who had not adhere the inclusion/exclusion criteria, had less than 3 recorded Hb values, and received any other epoetin alpha and blood transfusion in Weeks 0 to 44.||percentage of participants|||Number
751755|NCT00560417|Secondary|Total Daily Insulin Dose at Endpoint (LOCF)||Endpoint (LOCF) up to 24 weeks|All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.||Units of Insulin||Standard Deviation|Mean
751756|NCT00560417|Secondary|Change From Baseline in Body Weight at Endpoint (LOCF)||Baseline, Endpoint (LOCF) up to 24 weeks|All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.||kilograms||Standard Deviation|Mean
751757|NCT00560417|Secondary|Actual Body Weight at Baseline and Endpoint (LOCF)||Baseline, Endpoint (LOCF) up to 24 weeks|All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.||kilograms||Standard Deviation|Mean
751860|NCT00553787|Primary|Percent Weight Loss From Baseline to Week 56||Baseline to 56 weeks|intent-to-treat last-observation-carried-forward (ITT-LOCF)||percent weight loss||Standard Error|Least Squares Mean
751758|NCT00560417|Secondary|Rate of All, Non-Nocturnal, and Nocturnal Self-Reported Hypoglycemic Episodes (Adjusted for One Year)|Rate of self-reported hypoglycemic episodes, all, non-nocturnal, and nocturnal, at Endpoint (LOCF) and overall. Rate is reported as episodes/participant/365 days. Episode = any time participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia or has a blood glucose level of ≤70 mg/dL, even if it was not associated with signs, symptoms, or treatment. Overall=any time during the post-randomization visits within the study period. Nocturnal=Any episode that occurs between bedtime and waking. Non-Nocturnal=Any episode that occurs between waking and bedtime.|Baseline to Endpoint (LOCF) up to 24 weeks|All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.||episodes/participant/365 days||Standard Deviation|Mean
751759|NCT00560417|Secondary|Incidence of Self-reported Hypoglycemic Episodes (All, Non-Nocturnal, Nocturnal, and Severe)|Overall:any time after randomization.Episode:any time patient experienced sign/symptom associated with hypoglycemia, or had blood glucose level ≤70 mg/dL. Non-nocturnal:any episode that occurred between waking and bedtime. Nocturnal:any episode that occurred between bedtime and waking.Severe:episode with symptoms consistent with neuroglycopenia in which patient requires assistance,and is associated with:blood glucose value <50 mg/dL or prompt recovery after oral carbohydrate, glucagon, or intravenous glucose.Incidence(%)=(Number of patients experiencing episodes/number of patients in arm)*100.|Baseline to Endpoint (LOCF) up to 24 weeks|All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.||percentage of participants|||Number
751760|NCT00560417|Secondary|Glycemic Variability at Baseline and Endpoint (LOCF)|Glycemic variability was defined as the standard deviation (SD) of a participant's intra-day 7-point, self-monitored, blood glucose. Mean SD was calculated based on the SD for each participant in the study.|Baseline, Endpoint (LOCF) up to 24 weeks|All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.||mg/dL||Standard Deviation|Mean
751761|NCT00560417|Secondary|7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)|SMBG at morning pre-meal, morning post-prandial, midday pre-meal, midday post-prandial, evening pre-meal, evening postprandial, 0300 hours. Post-prandial glucose is measured 2 hours after the start of the meal.|Baseline, Endpoint (LOCF) up to 24 weeks|All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
751762|NCT00560417|Secondary|Percentage of Participants With Hemoglobin A1C Less Than 7.0% and Hemoglobin A1C Less Than or Equal to 6.5%||Weeks 12, 18, 24 and Endpoint (LOCF) up to 24 weeks|All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.||percent of participants|||Number
751763|NCT00560417|Secondary|Change From Baseline in Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)|Least squares mean values were controlled for Baseline + Baseline HbA1c Group + Baseline SU Group.|Baseline, 24 Weeks, Endpoint (LOCF) up to 24 weeks|All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.||percent of glycosylated hemoglobin||Standard Error|Least Squares Mean
751764|NCT00560417|Secondary|Actual Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)|Least squares mean values were controlled for Baseline + Baseline HbA1c Group + Baseline SU Group.|24 weeks, Endpoint (LOCF) up to 24 weeks|All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.||percent of glycosylated hemoglobin||Standard Error|Least Squares Mean
751765|NCT00560417|Primary|Change From Baseline in Hemoglobin A1C (HbA1c) at Endpoint (Last Observation Carried Forward [LOCF])|Least squares mean values were controlled for Baseline + Baseline HbA1c Group + Baseline sulfonylurea (SU) Group.|Baseline, Endpoint (LOCF) up to 24 weeks|All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.||percent of glycosylated hemoglobin||Standard Error|Least Squares Mean
751766|NCT00560508|Secondary|Change From Baseline in UPDRS Part IV Score (Open-label: Maintenance Phase)|UPDRS Part IV ranging from 0 (normal) to 23 (severe). UPDRS Part IV measures complications of therapy|baseline and after 64 weeks treatment|Full Analysis Set (FAS 2) for open label period with observed case (OC)||UPDRS scores on a scale||Standard Deviation|Mean
751767|NCT00560508|Secondary|Change From Baseline in UPDRS Part III Score (Open-label: Maintenance Phase)|UPDRS Part III ranging from 0 (normal) to 108 (severe). UPDRS Part III measures motor symptoms|baseline and after 64 weeks treatment|Full Analysis Set (FAS 2) for open label period with observed case (OC)||UPDRS scores on a scale||Standard Error|Least Squares Mean
751768|NCT00560508|Secondary|Change From Baseline in UPDRS Part II Score (Open-label: Maintenance Phase)|UPDRS Part II ranging from 0 (normal) to 52 (severe). UPDRS Part II is calculated as the average of UPDRS Part II at on and UPDRS Part II at off-period for each of the 13 activities.|baseline and after 64 weeks treatment|Full Analysis Set (FAS 2) for open label period with observed case (OC)||UPDRS scores on a scale||Standard Deviation|Mean
751769|NCT00560508|Secondary|Change From Baseline in UPDRS Part I Score (Open-label: Maintenance Phase)|UPDRS Part I ranging from 0 (normal) to 16 (severe). UPDRS Part I measures Mentation, Behavior and Mood|baseline and after 64 weeks treatment|Full Analysis Set (FAS 2) for open label period with observed case (OC)||UPDRS scores on a scale||Standard Deviation|Mean
751770|NCT00560508|Secondary|Change From Baseline in L-dopa Daily Dose (Open-label Maintenance Phase)|The L-dopa daily dose was recorded in the electronic case report form (eCRF) at each trial visit.|baseline and after 64 weeks treatment|Full Analysis Set (FAS 2) for open label period with observed case (OC)||mg per day||Standard Deviation|Mean
751771|NCT00560508|Secondary|Change From Baseline in Percentage On-time With Troublesome Dyskinesia (Open-label Maintenance Phase)|Percentage on-time with troublesome dyskinesia during waking hours in the last two days based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.|baseline and after 64 weeks treatment|Full Analysis Set (FAS 2) for open label period with observed case (OC)||Percentage of on-time||Standard Deviation|Mean
751772|NCT00560508|Secondary|Change From Baseline in Percentage On-time Without Dyskinesia or With Non-troublesome Dyskinesia (Open-label Maintenance Phase)|Percentage on-time without dyskinesia or non-troublesome dyskinesia during waking hours in the last two days based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.|baseline and after 64 weeks treatment|Full Analysis Set (FAS 2) for open label period with observed case (OC)||Percentage of on-time||Standard Deviation|Mean
751773|NCT00560508|Secondary|Change From Baseline in Percentage On-time With Non-troublesome Dyskinesia (Open-label Maintenance Phase)|Percentage on-time with non-troublesome dyskinesia during waking hours in the last two days based on patient diary data, percentage ranging from 0(worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.|baseline and after 64 weeks treatment|Full Analysis Set (FAS 2) for open label period with observed case (OC)||Percentage of on-time||Standard Deviation|Mean
751774|NCT00560508|Secondary|Change From Baseline in Percentage On-time Without Dyskinesia (Open-label: Maintenance Phase)|Percentage on-time without dyskinesia during waking hours in the last two days based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.|baseline and after 64 weeks treatment|Full Analysis Set (FAS 2) for open label period with observed case (OC)||Percentage of on-time||Standard Deviation|Mean
751775|NCT00560508|Secondary|Change From Baseline in Percentage Off-time (Open-label: Maintenance Phase)|Percentage off-time during waking hours in the last two days based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). Off-time describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease).|baseline and after 64 weeks treatment|Full Analysis Set (FAS 2) for open label period with observed case (OC)||Percentage of off-time||Standard Deviation|Mean
751776|NCT00560508|Secondary|UPDRS Parts II+III Total Score Responder Rate (at Least 20% Improvement) (Open-label: Maintenance Phase)|Responders are defined as at least 20% decrease in the UPDRS Parts II+III Total Score ranges 0-160 scores from best to worse|baseline and after 64 weeks treatment|Full Analysis Set (FAS 2) for open label period with observed case (OC)||percentage of participants|||Number
751777|NCT00560508|Secondary|Change From Baseline in UPDRS (Unified Parkinson's Disease Rating Scale) Parts II+III Total Score (Open-label: Maintenance Phase)|UPDRS II+III ranging from 0 point(normal) to 160 point (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms|Baseline and after 64 weeks treatment|Full Analysis Set (FAS 2) for open label period with observed case (OC)||UPDRS scores on a scale||Standard Deviation|Mean
751778|NCT00560508|Secondary|Patient Global Impression of Improvement (PGI-I) at Week 16 Compared to Patient's PGI-I Status at Week 12 (Open-label: Dose Adjustment Phase)|Patient Global Impression of Improvement (PGI-I) at week 16 compared to patient's PGI-I status at week 12. PGI-I scores ranging from '1' (very much better) to '7' (very much worse).|Week 12 to Week 16|Full Analysis Set (FAS 2) for open label period with observed case (OC)||percentage of participants|||Number
751779|NCT00560508|Secondary|Clinical Global Impression of Improvement (CGI-I) at Week 16 Compared to Patient's CGI-I Status at Week 12 (Open-label: Dose Adjustment Phase)|Clinical Global Impression of Improvement (CGI-I) at week 16 compared to patient's CGI-I status at week 12. CGI-I scores ranging from '1' (very much improved) to '7' (very much worse)|Week 12 to Week 16|Full Analysis Set (FAS 2) for open label period with observed case (OC)||percentage of participants|||Number
751780|NCT00560508|Secondary|Percentage of Patients With no Worsening of UPDRS Parts II+III Total Score by More Than 15% From Week 12 to Week 16 (Open-label: Dose Adjustment Phase)|Percentage of patients with no worsening of UPDRS Parts II+III Total Score by more than 15% from week 12 to week 16 (Open-label: Dose Adjustment Phase)|Week 12 to Week 16|Full Analysis Set (FAS 2) for the open-label period||percentage of participants|||Number
751781|NCT00560508|Secondary|Change From End of Double-Blind Period in UPDRS (Unified Parkinson's Disease Rating Scale) Parts II+III Total Score (Open-label: Dose Adjustment Phase)|UPDRS II+III ranging from 0 point(normal) to 160 point (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms. Least square means and standard errors presented are from ANCOVA with factors treatment and covariate baseline.|Week 12 to Week 16|Full Analysis Set (FAS 2) for open label period with observed case (OC)||UPDRS scores on a scale||Standard Error|Least Squares Mean
751782|NCT00560508|Secondary|Dose Proportionality of Trough Plasma Concentration at Steady State After Pramipexole ER Treatment|Dose proportionality of trough plasma concentrations at steady state is explored by using the power model that described the functional relationship between the dose and plasma concentration|from Visit 1 to Visit 8 after pramipexole ER|Full Analysis Set (FAS).||ng/mL|Participants|Standard Error|Mean
751783|NCT00560508|Secondary|Trough Plasma Concentration at Steady State|Geometric mean (gMean) was calculated for trough plasma concentrations of pramipexole at steady state after administration of pramipexole IR 4.5mg and pramipexole ER 4.5mg.|at Visit 8 after pramipexole ER 4.5mg and IR 4.5mg treatment|Full Analysis Set (FAS)||ng/ml||Standard Deviation|Geometric Mean
751784|NCT00560508|Primary|Percentage of Participants Who Experienced Adverse Events|An adverse event is defined as any untoward medical occurrence|12 weeks|Treated set for safety, which was the analysis set including all the patients who had valid measurements after drug administration.||percentage of participants|||Number
751785|NCT00560508|Secondary|Change From Baseline in L-dopa Daily Dose|The L-dopa daily dose was recorded in the electronic case report form (eCRF) at each trial visit.|baseline and after 12 weeks treatment|Full Analysis Set (FAS) with last observation carried forward (LOCF)||mg per day||Standard Error|Least Squares Mean
751786|NCT00560508|Secondary|UPDRS Parts II+III Total Score Responder Rate (at Least 20% Improvement)|Responders are defined as at least 20% decrease in the UPDRS Parts II+III Total Score ranges 0-160 scores from best to worse|baseline and after 12 weeks treatment|Full Analysis Set (FAS) with last observation carried forward (LOCF)||percentage of participants|||Number
751787|NCT00560508|Secondary|Change From Baseline in UPDRS Part IV Score|UPDRS Part IV ranging from 0 (normal) to 23 (severe). UPDRS Part IV measures complications of therapy|baseline and after 12 weeks treatment|Full Analysis Set (FAS) with last observation carried forward (LOCF)||UPDRS scores on a scale||Standard Error|Least Squares Mean
751788|NCT00560508|Secondary|Change From Baseline in UPDRS Part III Score|UPDRS Part III ranging from 0 (normal) to 108 (severe). UPDRS Part III measures motor symptoms|baseline and after 12 weeks treatment|Full Analysis Set (FAS) with last observation carried forward (LOCF)||UPDRS scores on a scale||Standard Error|Least Squares Mean
751789|NCT00560508|Secondary|Change From Baseline in UPDRS Part II Score|UPDRS Part II ranging from 0 (normal) to 52 (severe). UPDRS Part II is calculated as the average of UPDRS Part II at on and UPDRS Part II at off-period for each of the 13 activities.|baseline and after 12 weeks treatment|Full Analysis Set (FAS) with last observation carried forward (LOCF)||UPDRS scores on a scale||Standard Error|Least Squares Mean
751792|NCT00560508|Secondary|Responder Rate For Clinical Global Impression of Improvement (CGI-I)|CGI-I scores ranging from '1' (very much improved) to '7' (very much worse), CGI-I responder have scoring of 1 or 2 (at least much improved)|baseline and after 12 weeks treatment|Full Analysis Set (FAS) with last observation carried forward (LOCF)||percentage of participants|||Number
751793|NCT00560508|Secondary|Change From Baseline in Percentage On-time With Troublesome Dyskinesia|Percentage on-time with troublesome dyskinesia during waking hours in the last two days based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.|baseline and after 12 weeks treatment|Full Analysis Set (FAS) with last observation carried forward (LOCF)||Percentage of on-time||Standard Error|Least Squares Mean
751794|NCT00560508|Secondary|Change From Baseline in Percentage On-time Without Dyskinesia or With Non-troublesome Dyskinesia|Percentage on-time without dyskinesia or non-troublesome dyskinesia during waking hours in the last two days based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.|baseline and after 12 weeks treatment|Full Analysis Set (FAS) with last observation carried forward (LOCF)||Percentage of on-time||Standard Error|Least Squares Mean
751795|NCT00560508|Secondary|Change From Baseline in Percentage On-time With Non-troublesome Dyskinesia|Percentage on-time with non-troublesome dyskinesia during waking hours in the last two days based on patient diary data, percentage ranging from 0(worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.|baseline and after 12 weeks treatment|Full Analysis Set (FAS) with last observation carried forward (LOCF)||Percentage of on-time||Standard Error|Least Squares Mean
751796|NCT00560508|Secondary|Change From Baseline in Percentage On-time Without Dyskinesia|Percentage on-time without dyskinesia during waking hours in the last two days based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.|baseline and after 12 weeks treatment|Full Analysis Set (FAS) with last observation carried forward (LOCF)||Percentage of on-time||Standard Error|Least Squares Mean
751797|NCT00560508|Secondary|Change From Baseline in Percentage Off-time|Percentage off-time during waking hours in the last two days based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). Off-time describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease).|baseline and after 12 weeks treatment|Full Analysis Set (FAS) with last observation carried forward (LOCF)||Percentage of off-time||Standard Error|Least Squares Mean
751798|NCT00560508|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts II+III Total Score|UPDRS II+III ranging from 0 point(normal) to 160 point (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms|baseline and after 12 weeks treatment|Full Analysis Set (FAS) with last observation carried forward (LOCF)||UPDRS scores on a scale||Standard Error|Least Squares Mean
751799|NCT00560560|Secondary|Counts of Circulating Tumor Cells (CTCs)|The quantification of circulating tumor cells (CTCs)in this patient population. Blood samples were collected, and were measured using an automated microscope system.|Cycle 1 pre-dosing and Cycle 4 pre-dosing|"All enrolled participants who started treatment and who have at least one sample submitted. The total number of participants for this outcome measure was less than the original population. N means the numbers of units analyzed in Pre-treatment and/or Baseline, and Post-Baseline and/or Follow-up, respectively."||Number of CTC/ml of blood||Standard Deviation|Median
751800|NCT00560560|Secondary|Counts of Circulating Tumor Cells (CTCs) Expressing Positive Insulin-like Growth Factor 1 Receptor (IGF-1R)|The quantification of circulating tumor cells (CTCs) expressing the IGF-1R in this patient population. Blood samples were collected, and were measured using an automated microscope system.|Cycle 1 pre-dosing and Cycle 4 pre-dosing|"All enrolled participants who started treatment and who have at least one sample submitted. The total number of participants for this outcome measure was less than the original population. N means the numbers of units analyzed in Pre-treatment and/or Baseline, and Post-Baseline and/or Follow-up, respectively."||number of CTC expressing IGF-1R/ml blood||Standard Deviation|Median
751801|NCT00560560|Secondary|Participants Reporting Positive for Total Anti-drug Antibodies (ADA)|The immunogenicity of figitumumab in terms of producing an antidrug antibody (ADA) response were monitored.|Up to 2 hours prior to infusion in Cycles 1 and 4, at the end of treatment, and at the 4th scheduled follow-up visit (~150 days after the last infusion)|Participants for whom at least one ADA measurement was done. The outcome was not analyzed and only listing of ADA level for each participant was available.|||||
751802|NCT00560560|Secondary|Descriptive Summary of Figitumumab Concentration Versus Time|The measurement of mean plasma concentration of figitumumab in Day 1 of Cycle 1,2,3,4,5|Pre-dose on Day 1, 1 hour after end of infusion (post-dose) on Day 2 in Cycle 1, pre-dose on Day 1 in Cycles 2,3,4, 1 hour post-dose on Day 1 in Cycle 5|All participants for whom PK was assessed at least once. The numbers of participants analyzed are numbers of observation (non-missing concentrations). The numbers for 20 mg/kg group are 84,7,3,2,13 for five cycles, respectively. The numbers for 30 mg/kg group are 79,8,2,2,8 for five cycles, respectively.||miligrams/liter (mg/L)||Standard Deviation|Mean
751803|NCT00560560|Secondary|Percentage of Participants With Objective Response|Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as complete disappearance of all target and non-target disease. PR applied only to participants with at least one measurable lesion. Greater than or equal to 30 % decrease under baseline of the sum of longest diameters of all target measurable lesions.|Baseline, every cycle (Day 15-21 or according to local standard), end of treatment (within 28 days of last dose of study drug) and follow-up (150 days after last dose of study drug), up to 33 months|Per protocol. All enrolled participants who started treatment, with measurable disease and adequate baseline assessment.||Percentage of participants||95% Confidence Interval|Number
751817|NCT00560573|Secondary|Maximum Observed Plasma Concentration (Cmax) for Gemcitabine|Gemcitabine PK data was analyzed using noncompartmental methods. Plasma exposure parameters for gemcitabine were analyzed in the absence (Cycle) 1 and presence (Cycle 2) of figitumumab|0 (pre-dose), 0.417, 1, 1.5, 2.5, 3.5 hr on Cycle 1, Day 1 and Cycle 2, Day 8|PK analysis set: All enrolled participants who started treatment and had on-study samples to provide interpretable results.||ng/L||Standard Deviation|Mean
751804|NCT00560560|Secondary|Progression-Free Survival (PFS)|The period from study entry until disease progression. Participants without progression or death were censored at time of last disease assessment. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as 20% increase in the sum of longest diameters of target measurable lesions, or a clear increase in a non-target lesion, or the apprearance of new lesions.|Baseline until tumor progression or censorship, up to 33 months. The frequency of tumor assessments was screening, every cycle, end of treatment (within 28 days of last dose of study drug), and follow-up.|All enrolled participants.||months||95% Confidence Interval|Median
751805|NCT00560560|Secondary|Overall Survival|The time from date of enrollment to date of death due to any cause. For participants who were last known to be alive, overall survival was censored at the last contact date.|From date of enrollment until death or censorship, up to 33 months|All enrolled participants.||Months||95% Confidence Interval|Median
751806|NCT00560560|Primary|Estimate of the 6 Month Survival Probability|The 6 month survival probability was defined as the probability of survival at 6 months based on the Kaplan-Meier estimate. The time was from date of enrollment to date of death due to any cause. For participants who were last known to be alive, overall survival was censored at the last contact date.|Baseline up to Month 6|All enrolled participants.||Percent chance of survival||95% Confidence Interval|Number
751807|NCT00560573|Other Pre-specified|Recommended Phase 2 Dose (RP2D)|The RP2D was determined after review and discussion by sponsor and investigators of the study data. Consideration was given to type and severity of toxicity as well as clinical suitability for long-term administration|Baseline to end of dose escalation, which was assessed in the last participant of the dose escalation portion of the study in Month 19|Safety analysis set: All enrolled participants who received at least 1 dose of study medication.||mg/kg|||Number
751808|NCT00560573|Other Pre-specified|Maximum Tolerated Dose (MTD)|The MTD was defined as the highest dose level below the maximum administered dose which caused 0 or 1 out of 6 participants to experience a DLT in that given cohort at Cycle 1|Cycle 1, up to Day 21|Safety analysis set: All enrolled participants who received at least 1 dose of study medication.||mg/kg|||Number
751809|NCT00560573|Secondary|Serum Total Circulating Insulin-like Growth Factor (IGF-1) Levels|To monitor serum total IGF-1 levels as a potential pharmacodynamic response to figitumumab treatment|Baseline, Day 8, end of study|Biomarker analysis set: All enrolled participants who received at least 1 dose of study medication.||ng/mL||Inter-Quartile Range|Mean
751810|NCT00560573|Secondary|Percentage of Participants With Blood Anti-drug Antibody (ADA) Specific for Figitumumab|Percentage of participants with positive total or neutralizing anti-drug antibody (ADA) for figitumumab|30 min prior to figitumumab infusion in Cycle 1 and Cycle 4, end of study, fourth follow up visit (approximately 150 days after last dose)|ADA analysis set: All enrolled participants who received at least 1 dose of study medication.||Percentage of participants|||Number
751811|NCT00560573|Secondary|Duration of Response (DR)|For responding patients (CR and PR): Time from the date that CR or PR was first recorded to the date of the first documentation of progression|Screening, from Cycle 2 onwards CT scan done within 7-10 days prior to next cycle (approximately Day 15 of each cycle), follow-up (30 days after last study treatment dose)|No analysis of this parameter was performed. Due to the exploratory nature of the study, the analysis of the efficacy of figitumumab was limited to the assessment of clinical benefit response and PFS.|||||
751812|NCT00560573|Secondary|Progression-Free Survival (PFS)|Time from the date of enrollment to date of documented disease progression, or death due to any cause|Screening, from Cycle 2 onwards CT scan done within 7-10 days prior to next cycle (approximately Day 15 of each cycle), follow-up (30 days after last study treatment dose)|Efficacy analysis set: All participants with measurable disease at baseline, receiving at lesast 1 dose of figitumumab with a response assessment made by the investigator according to the RECIST system.||months||95% Confidence Interval|Median
751813|NCT00560573|Secondary|Percentage of Participants With Objective Response or Prolonged Stabilization|Percentage of participants with a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) for at least 12 weeks on study according to Response Evaluation Criteria in Solid Tumors (RECIST). Participants with non measurable disease were considered having a clinical benefit response only in the case of achievement of CR. Participants who developed early progressive disease post dosing and prior to response evaluation were considered to have progressed on study. Confirmed responses were those that persisted on repeat imaging >= 4 weeks after initial response|Screening, from Cycle 2 onwards computerized tomography (CT) scan done within 7-10 days prior to next cycle (approximately Day 15 of each cycle), follow-up (30 days after last study treatment dose)|Efficacy analysis set: All participants with measurable disease at baseline, receiving at lesast 1 dose of figitumumab with a response assessment made by the investigator according to the RECIST system.||Percentage of participants||95% Confidence Interval|Number
751814|NCT00560573|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Pemetrexed|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). Pemetrexed PK data was analyzed using noncompartmental methods. Plasma exposure parameters for pemetrexed were analyzed in the absence (Cycle 1) and presence (Cycle 2) of figitumumab|0, 0.167, 1.167, 2.167, 4.167, 6.167, 24.167 hr on Cycle 1, Day 1 and Cycle 2, Day 1 for pemetrexed 500 mg/m^2|PK analysis set: All enrolled participants who started treatment and had on-study samples to provide interpretable results.||ng*hr/L||Standard Deviation|Mean
751815|NCT00560573|Secondary|Maximum Observed Plasma Concentration (Cmax) for Pemetrexed|Pemetrexed PK data was analyzed using noncompartmental methods. Plasma exposure parameters for pemetrexed were analyzed in the absence (Cycle 1) and presence (Cycle 2) of figitumumab|0, 0.167, 1.167, 2.167, 4.167, 6.167, 24.167 hr on Cycle 1, Day 1 and Cycle 2, Day 1 for pemetrexed 500 mg/m^2|PK analysis set: All enrolled participants who started treatment and had on-study samples to provide interpretable results.||ng/mL||Standard Deviation|Mean
751816|NCT00560573|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Gemcitabine|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). Gemcitabine PK data was analyzed using noncompartmental methods. Plasma exposure parameters for gemcitabine were analyzed in the absence (Cycle 1) and presence (Cycle 2) of figitumumab|0 (pre-dose), 0.417, 1, 1.5, 2.5, 3.5 hr on Cycle 1, Day 1 and Cycle 2, Day 8|PK analysis set: All enrolled participants who started treatment and had on-study samples to provide interpretable results.||ng*hr/L||Standard Deviation|Mean
751818|NCT00560573|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Cisplatin|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). Cisplatin PK data was analyzed using noncompartmental methods. Plasma exposure parameters for cisplatin were analyzed in the absence (Cycle 1) and presence (Cycle 2) of figitumumab|0 (pre-dose), 1.917, 2.5, 3, 4, 5, 24 hr on Cycle 1, Day 1 and Cycle 2, Day 1 for cisplatin 75 mg/m^2 and 0 (pre-dose), 0.917, 1.5, 2, 3, 4, 23 hr on Cycle 1, Day 1 and Cycle 2, Day 1 for cisplatin 80 mg/m^2|PK analysis set: All enrolled participants who started treatment and had on-study samples to provide interpretable results.||ng*hr/L||Standard Deviation|Mean
751819|NCT00560573|Secondary|Maximum Observed Plasma Concentration (Cmax) for Cisplatin|Cisplatin PK data was analyzed using noncompartmental methods. Plasma exposure parameters for cisplatin were analyzed in the absence (Cycle 1) and presence of (Cycle 2) figitumumab|0 (pre-dose), 1.917, 2.5, 3, 4, 5, 24 hr on Cycle 1, Day 1 and Cycle 2, Day 1 for cisplatin 75 mg/m^2 and 0 (pre-dose), 0.917, 1.5, 2, 3, 4, 23 hr on Cycle 1, Day 1 and Cycle 2, Day 1 for cisplatin 80 mg/m^2|PK analysis set: All enrolled participants who started treatment and had on-study samples to provide interpretable results.||nanogram (ng)/mL||Standard Deviation|Mean
751820|NCT00560573|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) for Figitumumab|Concentration at the end of Cycle 4|0 (pre-dose) in Cycle 5 Day 1|PK analysis set: All enrolled participants who started treatment and had on-study samples to provide interpretable results.||mg/L||Standard Deviation|Mean
751821|NCT00560573|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Figitumumab|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). Figitumumab PK data was analyzed using noncompartmental methods|0 (pre-dose), 1, 24, 72, 168, 336, 504 hr in Cycle 1 for dose escation and 0 (pre-dose), 1, 24, 72, 168, 336, 504 hr in Cycle 4 for expansion|PK analysis set: All enrolled participants who started treatment and had on-study samples to provide interpretable results.||mg*hr/L||Standard Deviation|Mean
751822|NCT00560573|Secondary|Concentration at the End of Infusion (Cinf) for Figitumumab|Figitumumab pharmacokinetic (PK) data was analyzed using noncompartmental methods|Cycle 1 for dose escalation and Cycle 4 for dose expansion|PK analysis set: All enrolled participants who started treatment and had on-study samples to provide interpretable results.||mg/liter (L)||Standard Deviation|Mean
751823|NCT00560573|Primary|Number of Participants With Dose-limiting Toxicities (DLT)|Cycle 1 figitumumab attributed: Grade (Gr) 4 neutropenia (absolute neutrophil count <500 cells/cubic millimeter [mm^3]) >=7 days, febrile neutropenia (Gr 3, fever >=38.5 degrees Celsius), neutropenic infection (Gr 3 neutropenia, infection); Gr 4 thrombocytopenia (platelet <25,000 cells/mm^3), Gr 3 thrombocytopenia >=7 days/bleeding; other Gr 3 not blood/bone marrow Common Terminology Criteria for Adverse Events bar gastrointestinal toxicity, treatment-managed hyperglycemia/fatigue, hypersensitivity; Gr 3-4 hyperglycemia despite treatment; fail to adequately recover to continue study treatment|Start of treatment up to end of Cycle 1, Day 21|Safety analysis set: All enrolled participants in the dose escalation who received at least 1 dose of study medication.||participants|||Number
751824|NCT00560612|Secondary|Sheehan Disability Scale (SDS)|"Rates the following (scale 1-10; 1= not at all, 10=extremely) Work, Social Life, Family Life/Home Responsibilities.
Perceived Stress and Social Supports Scale (scale 1-10; 1= not at all, 10=extremely) Perceived stress, perceived social support"|12 weeks||||||
751825|NCT00560612|Secondary|Symptom Checklist 90|"Individual symptom scales are determined (via computer scoring) as follows:
SOM - Somatization O-C - Obsessive-Compulsive I-S - Interpersonal Sensitivity DEP - Depression ANX - Anxiety HOS - Hostility PHOB - Phobic Anxiety PAR - Paranoid Ideation PSY - Psychoticism
Global Indices Global Severity Index (GSI): Designed to measure overall psychological distress.
Positive Symptom Distress Index (PSDI): Designed to measure the intensity of symptoms.
Positive Symptom Total (PST): Reports number of self-reported symptoms."|12 weeks||||||
751826|NCT00560612|Secondary|Clinical Global Impressions of Severity and of Improvement Scales|"The severity of illness is rated on a scale of 1-7; 1 being normal and 7 being among the most extremely ill patients.
Global improvement is similarly rated on a scale of 1-7; 1 being very much improved and 7 being very much worse."|12 weeks||||||
751827|NCT00560612|Secondary|Hospital Anxiety and Depression Scale|Separate depression and anxiety scores are determined from this measure. Possible ranges for both depression and anxiety scores: 0-21. 0-7 (normal); 8-10 (borderline abnormal); 11-21 (abnormal).|12 weeks||||||
751828|NCT00560612|Secondary|Connor Davidson Resilience Scale|This scale measures resilience. Range of scores (0-100). A score of 0 is suggestive of no resilience, a score of 100 is suggestive of high level of resilience.|12 weeks||||||
751829|NCT00560612|Secondary|Short PTSD Rating Interview|"8 questions rated on 0-4 scale (0=not at all; 4=very much). One question assesses how much better the subject feels since beginning treatment (0-100; 0= no change; 100= very much change). Final question assesses how much symptoms have improved since starting treatment (forced choice: worse; no change; minimally; much; very much).
Total score is computed from questions #1-8 (range=0-32)."|12 weeks||||||
751830|NCT00560612|Primary|Clinician Administered PTSD Scale (CAPS)|"Mean change scores in posttraumatic stress disorder symptoms. Scores may range from 0 (no symptoms) to 136 (severe symptoms; score of 136 is based on the first 17 CAPS items administered).
A reduced CAPS score indicates a reduction in (improvement) PTSD symptoms, while an increase in CAPS score indicates an increase (worsening) in PTSD symptoms."|Baseline and 12 weeks|||Units on a scale||Standard Deviation|Mean
751831|NCT00560703|Primary|Change in Ocular Surface Disease Index (OSDI)|"OSDI is calculated based following formula using 12-question Ocular Surface Disease questionnaire (with each question scored 0-4):
OSDI = (D/E)x25, where D = Sum of all scores for questions answered E = Total number of questions answered (not including questions answered NA)
Range of OSDI is 0 to 100 (higher score indicates worse condition)."|Baseline to Week 12|||Scores on a scale||Standard Deviation|Mean
751832|NCT00560703|Primary|Change in Bulbar Conjunctival Hyperemia|"Bulbar conjunctival hyperemia will be assessed using an ordered categorical value ranging from 0 (Clear) to 4 (Severe). Hyperemia is graded on the following scale and half scores are acceptable:
None (0) = normal Mild (1) = slight localized injection Moderate (2) = pink color Severe (3) = red color Very Severe (4) = marked dark redness"|Baseline to Week 12|||Scores on a scale||Standard Deviation|Mean
751833|NCT00560794|Secondary|Terminal Half-life of Blinatumomab||Cycle 1 at predose and at 2, 6, and 12 hours after start of infusion then weekly until end of the cycle, and at 1, 2, 4, 6, 8, and 24 hours after stop of infusion.|Participants who received at least 1 infusion of blinatumomab with available pharmacokinetic data.||hours||Standard Deviation|Mean
751835|NCT00560794|Secondary|Apparent Volume of Distribution||Cycle 1 at predose and at 2, 6, and 12 hours after start of infusion then weekly until end of the cycle, and at 1, 2, 4, 6, 8, and 24 hours after stop of infusion.|Participants who received at least 1 infusion of blinatumomab with available pharmacokinetic data.||L/m²||Standard Deviation|Mean
751836|NCT00560794|Secondary|Area Under the Drug Concentration-time Curve From Time Zero to Infinity||Cycle 1 at predose and at 2, 6, and 12 hours after start of infusion then weekly until end of the cycle, and at 1, 2, 4, 6, 8, and 24 hours after stop of infusion.|Participants who received at least 1 infusion of blinatumomab with available pharmacokinetic data.||hr*ng/mL||Standard Deviation|Mean
751837|NCT00560794|Secondary|Serum Blinatumomab Concentration at Steady State|The mean serum concentration of blinatumomab during cycle 1. The LOQ of the assay was 100 pg/mL, and the limit of detection (LOD) was 3 pg/mL.|Cycle 1 at predose and at 2, 6, and 12 hours after start of infusion then weekly until end of the cycle, and at 1, 2, 4, 6, 8, and 24 hours after stop of infusion.|Participants who received at least 1 infusion of blinatumomab with available pharmacokinetic data.||pg/mL||Standard Deviation|Mean
751838|NCT00560794|Secondary|Serum Cytokine Peak Levels in Cycle 1|The activation of immune effector cells was monitored by the measurement of peripheral blood cytokine levels including interleukin (IL)-2, IL-4, IL-6, IL-8, IL-10, tumor necrosis factor (TNF)-α and interferon gamma (IFN)-γ using fluorescence-activated cell sorter (FACS)-based cytometric bead array (CBA) system.The limit of detection (LOD) for the cytokine determination was 20 pg/mL, the limit of quantification (LOQ) was 125 pg/mL.|Cycle 1 at pre-dose and at post infusion start at 45 minutes; 2, 6, 12, 24, and 48 hours; 7, 14, 21, and 28 days.|Safety analysis set||pg/mL||Standard Deviation|Mean
751839|NCT00560794|Secondary|Change From Screening Value in T-cell Count During Cycle 1|T-cells were measured by flow cytometry.|At Screening and in Cycle 1 at the start of infusion, 45 minutes, 2, 6, 12, 24 hours and at Days 2, 7, 14, 21, 28 and 35 after the start of infusion.|Participants who received blinatumomab with available pharmacodynamic data.||cells/μL||Standard Deviation|Mean
751840|NCT00560794|Secondary|Change From Screening Value in B-cell Count During Cycle 1|B-cells were measured by flow cytometry.|At Screening and in Cycle 1 at the start of infusion, 45 minutes, 2, 6, 12, 24 hours and at Days 2, 7, 14, 21, 28 and 35 after the start of infusion.|Participants who received blinatumomab with available pharmacodynamic data.||cells/μL||Standard Deviation|Mean
751841|NCT00560794|Secondary|Number of Participants With Adverse Events|"The severity (or intensity) of AEs was evaluated according to the grading scale provided in the Cancer Therapy Evaluation Program, Common Terminology Criteria for Adverse Events (CTCAE), version 3.0, or according to the following: Grade 1 – Mild AE; Grade 2 – Moderate AE; Grade 3 - Severe AE; Grade 4 - Life-threatening or disabling AE; Grade 5 - Death.
The investigator used medical judgment to determine if there was a causal relationship (ie, related, unrelated) between an adverse event and blinatumomab.
A serious adverse event (SAE) is any untoward medical occurrence or effect that, at any dose results in death, is life-threatening, requires or prolongs hospitalization, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect. In addition, all laboratory abnormalities of grade four severity that occur during or after administration of the investigational drug, any overdose and a pregnancy or fathering were reported as SAEs."|From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.|Safety analysis set, including all participants who received ≥ 1 infusion of blinatumomab.||participants|||Number
751842|NCT00560794|Secondary|Time to MRD Relapse|"Time to MRD relapse is defined only for participants with an MRD response during the study, defined as the time between the date of the first MRD response and the date of MRD relapse. If a participant experienced hematological relapse without having shown MRD positivity before then the time point of MRD relapse is defined as the time point of hematological relapse. Participants without an event of MRD relapse or hematological relapse were censored on the day of their last available bone marrow aspiration/biopsy. If a participant received a bone marrow transplant the last day of bone marrow aspiration/biopsy before transplantation was used as time point for censoring.
MRD relapse is defined as reappearance of bcr/abl, and/or t(4;11) translocation at any detection level, and/or by individual rearrangements of immunoglobulin or T-cell receptor genes ≥10^-4 for at least 1 individual marker measured by an assay with a sensitivity of minimum 10^-4 and should be confirmed within 6 weeks."|Up to the data cut-off date of 14 January 2010; Median follow-up time was 116.5 days|Full analysis set||days||95% Confidence Interval|Median
751843|NCT00560794|Secondary|Time to MRD Progression|"Time to MRD progression is defined for participants who do not show MRD response at any time during the study as the time from start of first infusion until the first result of MRD progression or hematological relapse, if no MRD progression was diagnosed before hematological relapse. For participants who showed MRD response during the study the time to MRD progression is defined as the time from the date of the first MRD response to the date of MRD relapse. Participants without an event of MRD progression were censored on the day of their last bone marrow aspiration/biopsy. Participants who received a bone marrow transplant were censored on the last day of bone marrow aspiration/biopsy before transplantation.
MRD progression is defined as the increase in the MRD level by 1 log as compared to the baseline level (equal to a 10-fold increase in the number of MRD cells), and had to be confirmed within 6 weeks."|Up to the data cut-off date of 14 January 2010; Median follow-up time was 155 days|Full analysis set||days||95% Confidence Interval|Median
751844|NCT00560794|Secondary|Time to Hematological Relapse|"The time to hematological relapse is defined as the time between start of first infusion of blinatumomab and the first result of hematological relapse. Participants without an event of hematological relapse were censored on their last available date of bone marrow aspiration/biopsy.
Hematological relapse is defined as > 5% leukemia cells in bone marrow. Time to hematological relapse was analyzed using Kaplan-Meier methods."|Up to the data cut-off date of 14 January 2010; maximum duration of follow-up was 564 days.|Full analysis set||days||95% Confidence Interval|Median
751845|NCT00560794|Secondary|Percentage of Participants With an MRD Response After Each Treatment Cycle|"MRD Response is defined as:
If Philadelphia Chromosome (Ph)+ or t(4;11), response was achieved when Ph or t(4;11) was below detection limit and individual rearrangements of immunoglobulin or T-cell receptor genes are below 10^-4.
If Ph and t(4;11) negative, response was achieved when individual rearrangements of immunoglobulin or T-cell receptor genes are below 10^-4."|At the end of each treatment cycle - Weeks 4, 10, 16, and 22.|Full analysis set||percentage of participants||95% Confidence Interval|Number
751846|NCT00560794|Primary|Percentage of Participants With a Minimal Residual Disease (MRD) Response Within 4 Cycles of Treatment|"MRD Response is defined as:
If Philadelphia Chromosome (Ph) positive (+) or translocation (t) (4;11), response was achieved when Ph or t(4;11) was below detection limit and individual rearrangements of immunoglobulin or T-cell receptor genes are below 10^-4.
If Ph and t(4;11) negative, response was achieved when individual rearrangements of immunoglobulin or T-cell receptor genes are below 10^-4."|Within 4 treatment cycles, 24 weeks|Full analysis set||percentage of participants||95% Confidence Interval|Number
751847|NCT00560833|Primary|Change From Baseline in Average Daily Severity of Moderate/Severe Vasomotor Symptoms (Severity Score A) at Week 12|Participants recorded the severity of hot flushes on a LogPad on a daily basis during screening and treatment. The severity of hot flushes was defined as: mild (sensation of heat without sweating); moderate (sensation of heat with sweating, able to continue activity); and severe (sensation of heat with sweating, causing cessation of activity). Severity score A was calculated as the number of moderate hot flushes x 2 + the number of severe hot flushes x 3, divided by the total number of moderate and severe hot flushes. If no hot flushes were experienced, this was to be recorded as ‘no sensation of heat’. Baseline values were based on, at most, 7 completely observed pre-treatment days. If less than 4 days were completely observed during treatment, the averages of the previous week were carried forward (last observation carried forward, or LOCF). If the number of days observed in Week 1 were not sufficient, baseline values were carried forward.|Baseline and Week 12|The ITT population, defined as all randomized particpants having at least one recorded pre-baseline value of the number of moderate and severe hot flushes.||score on a scale||Standard Deviation|Mean
751848|NCT00560833|Primary|Change From Baseline in Average Daily Severity of Moderate/Severe Vasomotor Symptoms (Severity Score A) at Week 4|Participants recorded the severity of hot flushes on a LogPad on a daily basis during screening and treatment. The severity of hot flushes was defined as: mild (sensation of heat without sweating); moderate (sensation of heat with sweating, able to continue activity); and severe (sensation of heat with sweating, causing cessation of activity). Severity score A was calculated as the number of moderate hot flushes x 2 + the number of severe hot flushes x 3, divided by the total number of moderate and severe hot flushes. If no hot flushes were experienced, this was to be recorded as ‘no sensation of heat’. Baseline values were based on, at most, 7 completely observed pre-treatment days. If less than 4 days were completely observed during treatment, the averages of the previous week were carried forward (last observation carried forward, or LOCF). If the number of days observed in Week 1 were not sufficient, baseline values were carried forward.|Baseline and Week 4|The ITT population, defined as all randomized particpants having at least one recorded pre-baseline value of the number of moderate and severe hot flushes.||score on a scale||Standard Deviation|Mean
751849|NCT00560833|Primary|Change From Baseline in Average Daily Frequency of Vasomotor Symptoms (Frequency Score A) at Week 12|Participants recorded the frequency of vasomotor symptoms (hot flushes) on a LogPad on a daily basis during screening and treatment. Frequency score A was based on the number of moderate hot flushes + the number of severe hot flushes in one day. Baseline average was derived from, at most, 7 completely observed pre-treatment days. Weekly averages during treatment were calculated if at least 4 days with non-missing data were completely observed; if less than 4 days were completely observed, the averages of the previous week were carried forward (last observation carried forward, or LOCF). If the number of days observed in Week 1 were not sufficient, baseline values were carried forward.|Baseline and Week 12|The ITT population, defined as all randomized particpants having at least one recorded pre-baseline value of the number of moderate and severe hot flushes.||number of events||Standard Deviation|Mean
751850|NCT00560833|Secondary|Change From Baseline in Vasomotor Symptoms Score Per Women's Health Questionnaire (WHQ) at Week 12|The WHQ is a 36-item, user-friendly, and rapid way of assessing nine domains of physical and emotional health for mid-aged women. Participants self-administered the WHQ questionnaire; scoring is based on a 4-point scale as follows: ‘Yes definitely=1’, ‘Yes sometimes=2’, ‘No not much=3’ and ‘No not at all=4’. Each score is transformed to a value ‘1’ for scores ‘1’ and ‘2’ and to a value ‘0’ for scores ‘3’ and ‘4’. Vasomotor symptoms encompass Items 19 and 27 of the 36 total items. The transformed sums of items 19+27 are divided by 2 to get the score; therefore, the domain ranges from 0 to 1, where lower values are better.|Baseline and Week 12|All participants receiving study drug with diary compliance adequate for this measure.||Score on a scale||Standard Deviation|Mean
751851|NCT00560833|Primary|Change From Baseline in Average Daily Frequency of Vasomotor Symptoms (Frequency Score A) at Week 4|Participants recorded the frequency of vasomotor symptoms (hot flushes) on an electronic diary card (LogPad®) on a daily basis during screening and treatment. Frequency score A was based on the number of moderate hot flushes + the number of severe hot flushes in one day. Baseline average was derived from, at most, 7 completely observed pre-treatment days. Weekly averages during treatment were calculated if at least 4 days with non-missing data were completely observed; if less than 4 days were completely observed, the averages of the previous week were carried forward (last observation carried forward, or LOCF). If the number of days observed in Week 1 were not sufficient, baseline values were carried forward.|Baseline and Week 4|The intent-to-treat (ITT) population, defined as all randomized particpants having at least one recorded pre-baseline value of the number of moderate and severe hot flushes.||Number of events||Standard Deviation|Mean
751852|NCT00553735|Secondary|Schirmer With Anesthesia||18 Months|No data were collected because participants withdrew themselves, failed to show for their appointments, or were lost to follow-up.|||||
751853|NCT00553735|Secondary|Schirmer Without Anesthesia||18 Months|No data were collected because participants withdrew themselves, failed to show for their appointments, or were lost to follow-up.|||||
751854|NCT00553735|Secondary|Tear Break-up Time (TBUT)||18 Months|No data were collected because participants withdrew themselves, failed to show for their appointments, or were lost to follow-up.|||||
751855|NCT00553735|Secondary|Symptom Assessment iN Dry Eye (SANDE) Patient Questionnaire||18 Months|No data were collected because participants withdrew themselves, failed to show for their appointments, or were lost to follow-up.|||||
751856|NCT00553735|Primary|Incidence and Severity of Ocular Adverse Event|Incidence and severity of ocular adverse events, as identified by eye examination and visual acuity testing.|18 Months|All patients enrolled in the study were analyzed.||participants|||Number
751857|NCT00553735|Primary|Conjunctival Staining Score||18 Months|No data were collected because participants withdrew themselves, failed to show for their appointments, or were lost to follow-up.|||||
751861|NCT00553839|Primary|Residual Error|"pK analysis of ketamine in children with pre-existing congenital heart disease following a single dose of ketamine in order to rationalize an effective 2-h anesthetic medication, personalized based on cardiac function and age.
Residual Error was analyzed using Bootstrap model."|5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360 and 720 minutes after bolus.|Children up to 18 years of age children with pre-existing congenital heart disease||proportional %||95% Confidence Interval|Median
751862|NCT00553839|Primary|Central and Peripheral Volume of Distribution|"pK analysis of ketamine in children with pre-existing congenital heart disease following a single dose of ketamine in order to rationalize an effective 2-h anesthetic medication, personalized based on cardiac function and age.
Central and Peripheral Volume of Distribution were analyzed using Bootstrap model."|5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360 and 720 minutes after bolus.|Children up to 18 years of age children with pre-existing congenital heart disease||L/70kg||95% Confidence Interval|Median
751863|NCT00553839|Primary|Total Clearance and Intercompartmental Clearance|"pK analysis of ketamine in children with pre-existing congenital heart disease following a single dose of ketamine in order to rationalize an effective 2-h anesthetic medication, personalized based on cardiac function and age.
Total Clearance and Intercompartmental Clearance were analyzed using Bootstrap model."|5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360 and 720 minutes after bolus.|Children up to 18 years of age children with pre-existing congenital heart disease||L/h/70kg||95% Confidence Interval|Median
751864|NCT00560859|Secondary|Change in Score of Pediatric Sleep Questionnaire Sleep-related Breathing Disorder Scale|Scores on the Pediatric Sleep Questionnaire sleep-related breathing disorder scale (PSQ-SRBD) range from 0 to 1, with higher scores indicating greater severity.|7 months following baseline.|There was missing data for some children in the Watchful Waiting group since the Pediatric Sleep Questionnaire was not completed. Hence these numbers are not consistent with the rows in the participant flow module||units on a scale||Standard Deviation|Mean
751865|NCT00560859|Secondary|Change in Apnea Hypopnea Index (AHI) Score From Baseline to 7 Months|The outcome measure was the change in AHI from baseline to 7 months to determine if there was an improvement in score is associated with improved OSAS (i.e reduction in AHI). The AHI is calculated by dividing the number of apnea events by the number of hours of sleep. The obstructive sleep apnea syndrome was defined as an AHI score of 2 or more events per hour or an obstructive apnea index (OAI) score of 1 or more events per hour.|7 months following the baseline visit.|||Events per hour||Inter-Quartile Range|Median
751866|NCT00560859|Primary|Improvements in Attention/Executive Domain Index of the Developmental Neuropsychological Assessment (NEPSY) From Baseline to 7 Months.|The primary outcome was the change in the attention and executive function score on the NEPSY. The change from baseline in Attention/Executive Domain Index of the Developmental Neuropsychological Assessment (NEPSY) was compared to 7 months were compared. Scores on the attention and executive-function domain of the Developmental Neuropsychological Assessment (NEPSY) range from 50 to 150, with higher scores indicating better functioning.|The primary endpoint measure will occur at 7 months following the baseline visit.|||units on a scale||Standard Deviation|Mean
751867|NCT00560885|Secondary|Composite 6-month Post-procedure Major Adverse Event Rate.||6 Months Post Procedure|Safety was evaluated in all subjects enrolled and treated with the device.||percentage of subjects||95% Confidence Interval|Number
751868|NCT00560885|Secondary|Percent of Patients Free From AF, Independent of Antiarrhythmic Drug Status as Determined by Holter Monitoring at 6 Months.||6 Months Post Procedure|The analysis population included subjects that were evaluable for the Secondary Efficacy Endpoint. The completer population excluded 5 subjects. These were 2 post op deaths, 2 deaths beyond 3 months but less than 6 months and 1 subject that withdrew at the 30 day visit.||percentage of subjects||95% Confidence Interval|Number
751869|NCT00560885|Primary|Composite Acute Major Adverse Event Rate, Within 30 Days Post-procedure or Hospital Discharge|Major Adverse Events consist of Death within 30 days or beyond 30 days if considered device related, Excessive Bleeding, Stroke, TIA or MI. A clinic visist was performed at 30 days to fully assess the patient for adverse events.|30 days Post Procedure|Safety was evaluated in all subjects enrolled and treated with the device.||percentage of subjects||95% Confidence Interval|Number
751870|NCT00560885|Primary|Percent of Patients Free From AF and Off Class I and III Anti-arrhythmic Drugs as Determined by Holter Monitoring at 6 Months.||6 Months Post Procedure|The analysis population included subjects that were evaluable for the Primary Efficacy Endpoint. The completer population excluded 5 subjects. These were 2 post op deaths, 2 deaths beyond 3 months but less than 6 months and 1 subject that withdrew at the 30 day visit.||percentage of subjects||95% Confidence Interval|Number
751871|NCT00560937|Secondary|Mean Score on the Positive and Negative Symptom Scale (PANSS)|The PANSS is a widely used measure with several subdomains, including positive symptoms, negative symptoms, and general psychopathology of schizophrenia. Lower scores are indicative of fewer symptoms; higher scores are indicative of more symptoms. Total PANSS scores range from 0-20.|Change in PANSS scores at baseline and 8 weeks post-randomization (at least 4 weeks; last observation carried forward)|||units on a scale||Standard Deviation|Mean
751872|NCT00560937|Secondary|Clinical Global Impression Scale (CGI-I)|The CGI-I is a commonly used psychiatric scale to assess overall general improvement. The CGI-I consists of one interviewer-rated question on a scale of 1-7. Lower scores are indicative of fewer symptoms; while higher scores are indicative of more symptoms.|CGI-I scores at 8 weeks post-randomization (at least 4 weeks; last observation carried forward)|||units on a scale||Standard Deviation|Mean
751873|NCT00560937|Primary|Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS)|The MATRICS is a battery for the assessment of cognitive symptoms in patients with schizophrenia. Composite T-scores are calculated (T-score ranges are -20 to +80, and are normed on gender and age). Higher scores are indicative of better cognitive performance, lower scores are indicative of poorer cognitive performance.|Change in composite MATRICS scores at baseline and 8 weeks post-randomization (at least 4 weeks; last observation carried forward)|||units on a scale||Standard Deviation|Mean
751874|NCT00560937|Primary|Mean Change of Z-scores on the Brief Assessment of Cognition in Schizophrenia (BACS)|The BACS includes brief assessments of executive functions, verbal fluency, attention, verbal memory, working memory and motor speed. Z-scores are calculated from composite scores. Higher z-scores are indicative of better cognitive performance, lower z-scores are indicative of lower cognitive performance. Range of z-scores anticipated to be between -3 and 3.|Change in composite BACS scores at baseline and 8 weeks post-randomization (at least 4 weeks; last observation carried forward)|||units on a scale||Standard Deviation|Mean
751875|NCT00560937|Secondary|Mean Score Change in Calgary Depression Scale for Schizophrenia (CDSS)|The CDSS is used measure to investigate depressive symptoms in schizophrenia. The measure includes 9 questions ranked from 0 (no symptoms) to 3 (severe symptoms). Range of possible scores: 0-27.|Change in CDSS scores at baseline and 8 weeks (at least 4 weeks; last observation carried forward)|||units on a scale||Standard Deviation|Mean
751876|NCT00560937|Primary|Mean Score on the Scale for the Assessment of Negative Symptoms (SANS), p=0.048|The SANS assesses negative symptoms in schizophrenia. The SANS consists of 21 clinical interview questions assessing negative symptoms of schizophrenia. Each question is rated on a scale of 0 (no symptoms) to 7 (severe symptoms).|SANS scores at baseline and 8 weeks post-randomization (at least 4 weeks; last observation carried forward)|Pilot proof of concept study||units on a scale||Standard Deviation|Mean
751877|NCT00560950|Primary|Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 23F|Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA.|Day 1 & Day 30|All eligible participants||gpELISA units/mL||95% Confidence Interval|Geometric Mean
751878|NCT00560950|Primary|Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 14|Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA.|Day 1 & Day 30|All eligible participants||gpELISA units/mL||95% Confidence Interval|Geometric Mean
751879|NCT00560950|Primary|Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 12F|Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA.|Day 1 & Day 30|All eligible participants||gpELISA units/mL||95% Confidence Interval|Geometric Mean
751880|NCT00560950|Primary|Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 9V|Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA.|Day 1 & Day 30|All eligible participants||gpELISA units/mL||95% Confidence Interval|Geometric Mean
751881|NCT00560950|Primary|Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 8|"Blood drawn at Day 1 and Day 30 of the
extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA."|Day 1 & Day 30|All eligible participants||gpELISA units/mL||95% Confidence Interval|Geometric Mean
751882|NCT00560950|Primary|Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 6B|"Blood drawn at Day 1 and Day 30 of the
extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA."|Day 1 & Day 30|All eligible participants||gpELISA units/mL||95% Confidence Interval|Geometric Mean
751883|NCT00560950|Primary|Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 4|Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA.|Day 1 & Day 30|All eligible participants||gpELISA units/mL||95% Confidence Interval|Geometric Mean
751884|NCT00560950|Primary|Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 3|Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B,8, 9V, 12F, 14, 23F) by ELISA.|Day 1 & Day 30|All eligible participants||gpELISA units/mL||95% Confidence Interval|Geometric Mean
751885|NCT00561002|Other Pre-specified|Seroconversion Rates for Each Influenza Antigen Post-Vaccination|Seroconversion was defined as a post-vaccination titer ≥ 40 for participants with a titer < 10 on Day 0 and a ≥4-fold increase for participants with a titer ≥ 10 on Day 0.|Day 14 post-vaccination|The seroconversion analysis were on the per-protocol immunogenicity population.||Percentage of Participants|||Number
751886|NCT00561002|Other Pre-specified|Percentage of Participants With at Least a 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination (Seroprotection)|Seroprotection was defined as a serum hemagglutination inhibition antibody titer ≥40.|Day 14 post-vaccination|The serum hemagglutination inhibition antibody analysis were on the per-protocol immunogenicity population.||Percentage of Participants|||Number
751887|NCT00561002|Other Pre-specified|Geometric Mean Titers (GMTs) of Hemagglutinin Antibodies Pre- and Post-Fluzone® Vaccination||Day 0 and Day 14 after last dose of Fluzone|The Geometric Mean Titers analysis were on the per-protocol immunogenicity population.||Titers||95% Confidence Interval|Geometric Mean
751888|NCT00561002|Primary|Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation|Solicited injection site reactions: Erythema, swelling, pain/tenderness; Solicited systemic reactions: (for infants/toddlers) - fever, irritability, abnormal crying, drowsiness, lost appetite, vomiting; (for children) - fever, headache, malaise, myalgia) Note: Influenza-primed group received only dose 1.|Days 0-3 post-dose|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.||Participants|||Number
751889|NCT00561015|Secondary|Percentage of Participants Who Achieved Sustained Virological Response (SVR)|The SVR was defined as having HCV RNA undetectable at EOT, not showing relapse up to follow-up Week 12 (SVR12) or follow-up Week 24 (SVR24), and HCV RNA undetectable at follow-up Week 12 (SVR12) or follow-up Week 24 (SVR24), respectively. The EOT for group T2 & PR24 was 26 weeks and for groups T2/PR24 and Pbo/PR24 was 24 weeks.|Week 12, 24 after EOT|The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo.||percentage of participants|||Number
751921|NCT00561925|Secondary|Proportion of Sustained Virologic Response at Week 144 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population|Endpoint was the number of patients with a sustained virologic response through week 144 using LLOQ = 50 copies/mL|week 144|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of blinded medication||participants|||Number
751890|NCT00561015|Secondary|Percentage of Participants Who Demonstrated Virological Relapse|Relapse was defined as confirmed detectable HCV RNA (>=10 IU/ml) during the follow-up period up to 24 weeks after last medication intake and after previous undetectable HCV RNA (< 10 IU/ml) at EOT. No relapse was defined as having no confirmed detectable HCV RNA (>=10 IU/ml) during the follow-up period and after previous undetectable HCV RNA (< 10 IU/ml) at EOT. Missing follow-up means no HCV RNA measurements during the follow-up period and after previous undetectable HCV RNA (< 10 IU/ml) at EOT. The EOT for group T2 & PR24 was 26 weeks and for groups T2/PR24 and Pbo/PR24 was 24 weeks.|24 weeks after EOT|The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure.||percentage of participants|||Number
751891|NCT00561015|Secondary|Percentage of Participants With Viral Breakthrough|Viral breakthrough was defined as an increase in HCV RNA levels by more than 1 log10 in HCV RNA level from the lowest level reached, or a value of HCV RNA > 100 IU/ml in participants whose HCV RNA had previously become undetectable (< 10 IU/ml) or unquantifiable (< 25 IU/ml) during the considered treatment phase. It was considered as confirmed when the criterion for viral breakthrough is fulfilled at two or more consecutive time points or at the last observed time point in case of trial termination. The EOT for group T2 & PR24 was 26 weeks and for groups T2/PR24 and Pbo/PR24 was 24 weeks.|Baseline, Day 12, 15 and Week 24/26|The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo.||percentage of participants|||Number
751892|NCT00561015|Secondary|Median Time to Virological Response (HCV RNA Level < 10 IU/ml)|Virological response was defined as having HCV RNA level less than a particular threshold which is either less than 10 IU/ml (undetectable) or less than 25 IU/ml (unquantifiable).Time to virological response was defined as the number of days from the start of medication intake necessary to go for the first time below the threshold value. The EOT for group T2 & PR24 was 26 weeks and for groups T2/PR24 and Pbo/PR24 was 24 weeks.|Baseline up to EOT|The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo.||days||Full Range|Median
751893|NCT00561015|Secondary|Percentage of Participants Achieving Virological Response (HCV RNA Level < 10 IU/ml)|Virological response was defined as having HCV RNA level less than a particular threshold that is less than 10 IU/ml (undetectable).|Baseline, Day 12, 15, Week 4, 6, 14 and EOT (Week 24/26 or early discontinuation)|The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo. Here 'n' included those participants who were evaluable for this measure at specific time points.||percentage of participants|||Number
751894|NCT00561015|Primary|Area Under Plasma Concentration-Time Curve Over Dosing Interval (AUCtau) for Telaprevir on Day 1|The AUC is defined as area under the plasma concentration-time curve over the dosing interval (8 hr), calculated by the lin-up/ log-down method.|Pre-dose Day 1 (0.5, 1, 2, 3, 4, 6, 8 hr)|The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure.||ng*hr/ml||Standard Deviation|Mean
751895|NCT00561015|Secondary|Minimum Plasma Concentration (Cmin) for Telaprevir on Day 15|The Cmin is defined as minimum plasma concentration between 0 hr and dosing interval. The Cmin is measured in ng/ml.|Pre-dose Day 15 (0.5, 1, 2, 3, 4, 6, 8 hr)|The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure.||ng/ml||Standard Deviation|Mean
751896|NCT00561015|Secondary|Maximum Plasma Concentration (Cmax) for Telaprevir on Day 15|The Cmax is defined as the maximum observed analyte concentration. The Cmax is measured in ng/ml.|Pre-dose Day 15 (0.5, 1, 2, 3, 4, 6, 8 hr)|The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure.||ng/ml||Standard Deviation|Mean
751897|NCT00561015|Secondary|Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level at Week 24 and Week 26|Levels of HCV RNA in plasma were measured using COBAS TaqMan HCV test v2.0. Lower limit of quantification was 25 IU/ml and limit of detection was 10 IU/ml. The assay used real time RT-PCR methodology. End of treatment (EOT) for group T2 & PR24 was 26 weeks and for groups T2/PR24 and Pbo/PR24 was 24 weeks.|Baseline and Week 24/26|The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure.||log10 IU/ml||Full Range|Median
751898|NCT00561015|Secondary|Area Under Plasma Concentration-Time Curve Over Dosing Interval (AUCtau) for Telaprevir on Day 15|The AUC is defined as area under the plasma concentration-time curve over the dosing interval (8 hr), calculated by the lin-up/ log-down method.|Pre-dose Day 15 (0.5, 1, 2, 3, 4, 6, 8 hr)|The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure.||ng*hr/ml||Standard Deviation|Mean
751899|NCT00561015|Primary|Time to Reach Maximum Plasma Concentration (Tmax) for Telaprevir on Day 1|The Tmax is defined as the actual sampling time to reach maximum observed analyte concentration. The analyte concentration associated with Tmax is referred to as Cmax.|Pre-dose Day 1 (0.5, 1, 2, 3, 4, 6, 8 hr)|The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure.||hr||Full Range|Median
751900|NCT00561015|Primary|Maximum Plasma Concentration (Cmax) for Telaprevir on Day 1|The Cmax is defined as the maximum observed analyte concentration. The Cmax was measured in nanogram/milliliter (ng/ml).|Pre-dose Day 1 (0.5, 1, 2, 3, 4, 6, 8 hour [hr])|The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure.||ng/ml||Standard Deviation|Mean
751922|NCT00561925|Secondary|Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population||week 0 to 144|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of blinded medication||proportion of participants|||Number
752516|NCT00569777|Primary|Lid and Lid Margin Swelling, Change From Baseline|Assessment of lid swelling using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.||Units on a scale|Participants|Standard Deviation|Mean
751901|NCT00561015|Primary|Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level at Day 15|Level of HCV RNA in plasma was measured using COBAS TaqMan HCV test v2.0 (an in vitro nucleic acid amplification test for quantitation of HCV RNA genotypes 1 through 6 in human serum or plasma, using the COBAS AmpliPrep Total Nucleic Acid Isolation Kit (TNAI) for preparation of highly purified total nucleic acid from serum or plasma and automated amplification and detection on TaqMan 48 Analyzer). Lower limit of quantification was 25 international units/milliliter (IU/ml) and limit of detection was 10 IU/ml. Assay used was reverse transcription-polymerase chain reaction (RT-PCR) methodology.|Baseline, Pre-dose (Day 15)|Full analysis set (FAS) population included all randomly assigned participants who received at least 1 dose of TVR or placebo.||log10 IU/ml||Full Range|Median
751902|NCT00561145|Secondary|Expression of Genes Involved in Energy Metabolism||Before and after the energy restriction period.||||||
751903|NCT00561145|Secondary|Resting Energy Expenditure, Body Composition and Body Weight||Before and after the energy restriction period||||||
751904|NCT00561145|Secondary|Gastrointestinal Function||Before and after the energy restriction period||||||
751905|NCT00561145|Secondary|Appetite/Satiety Hormones and Questionnaires||Before and after the energy restriction period.||||||
751906|NCT00561145|Primary|Energy Intake Compensation|"To assess energy intake compensation, we will assess average energy intake during the ad libitum food intake phase - which is the period after energy restriction- in young men and compare this to average energy intake in older men.
Average energy intake is assessed by measuring total megajoule of energy intake during nine days of the ad lib phase, and then divide it by nine (MJ/day)"|Average intake of energy during ad lib phase (9 days)|completed (see publication)||MJ/day||Standard Deviation|Mean
751907|NCT00561834|Primary|Change in Visual Acuity|The mean change in best corrected Snellen visual acuity at 6 months in NAION patients treated as needed with ranibizumab.|Baseline and 6 months|||lines change in Snellen chart|||Number
751908|NCT00561912|Primary|Progression-free Survival (PFS) Times|Progression-free survival (PFS) times for participants with advanced renal cell carcinoma (RCC) treated with decitabine and interferon alfa-2b where PFS is defined as starting from day one of the treatment combination to disease progression or death for any reason, measured in weeks.|From treatment start or until disease progression or death for any reason, at least 16 weeks|With one of the two participants ruled ineligible and inevaluable, there was insufficient data for statistical evaluation.||Weeks|||Number
751909|NCT00561925|Secondary|Occurrence of Hepatic Events|Frequency of patients with hepatitis symptoms|until last patient completed 144 weeks (up to 193 weeks)|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of blinded medication||participants|||Number
751910|NCT00561925|Secondary|Relative Bioavailability Trough C_pre,ss,1|Relative bioavailability measured of trough concentrations. Analysis based on adjusted by-treatment geometric means, the adjusted geometric mean ratio of NVP XR : NVP IR and it's 90% confidence interval with p-value and the inter-individual geometric coefficient of variation.|week 132|Only patients with trough drawn PK time window (12+/-2.5 hr for IR; 24+/-5hr for XR) at week 132 are included.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
751911|NCT00561925|Secondary|Kaplan -Meier Estimate of Cumulative Probability of Group III or IV Drug-related Rash||week 0 to 72|Treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one doe of investigational treatment, including the lead in nevirapine dose||cumulative probability|||Number
751912|NCT00561925|Secondary|Kaplan -Meier Estimate of Cumulative Probability of Clinical Hepatic Events||week 0 to 72|Treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one doe of investigational treatment, including the lead in nevirapine dose||cumulative probability|||Number
751913|NCT00561925|Secondary|Kaplan -Meier Estimate of Cumulative Probability of Grade 3 or 4 Asymptotic Transaminases Abnormalities||week 0 to 72|Treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one doe of investigational treatment, including the lead in nevirapine dose||cumulative probability|||Number
751914|NCT00561925|Secondary|Kaplan -Meier Estimate of Cumulative Probability of Grade 3 or 4 ALT/AST Abnormalities||week 0 to 72|Treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one doe of investigational treatment, including the lead in nevirapine dose||cumulative probability|||Number
751915|NCT00561925|Secondary|Kaplan -Meier Estimate of Cumulative Probability of Permanent Discontinuation of Study Medication||week 0 to 144|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of blinded medication||cumulative probability|||Number
751916|NCT00561925|Secondary|Occurrence of Elevations in Laboratory Measurement by DAIDS Grade||until last patient completed 144 weeks (up to 193 weeks)|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of blinded medication||participants|||Number
751917|NCT00561925|Secondary|Occurrence of Rashes|Frequency of patients with drug related rash events by functional grouping|until last patient completed 144 weeks (up to 193 weeks)|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of blinded medication||participants|||Number
751918|NCT00561925|Secondary|Comparison of CD4+ Cell Count (Cells/Cubic Millimeter) Change From Baseline at Week 144, Full Analysis Set Population||baseline, week 144|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of blinded medication; descriptive analysis uses the imputation method: last observation carried forward; statistical analysis uses observed cases||cells/cubic millimeter||Standard Deviation|Mean
751919|NCT00561925|Secondary|Comparison of HIV-1 Viral Load (log10 Copies/mL) Change From Baseline at Week 144, Full Analysis Set Population||baseline, week 144|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of blinded medication; descriptive analysis uses the imputation method: last observation carried forward; statistical analysis uses observed cases||log10 copies/mL||Standard Deviation|Mean
751920|NCT00561925|Secondary|Kaplan-Meier Estimates for Time to New AIDS or AIDS-related Progression Event or Death, Full Analysis Set Population||week 0 to 144|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of blinded medication||proportion of participants|||Number
751923|NCT00561925|Primary|Comparison of Proportion of Virologic Response at Week 48 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population|Primary endpoint was the number of patients with a sustained virologic response through week 48 using LLOQ = 50 copies/mL|week 48|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of blinded medication||participants|||Number
751924|NCT00561951|Secondary|The Number of Patients With “Severe Problems, Score 5” or “Many Severe Problems, Score 6” in Patient Perception of Bladder Condition (PPBC) at Week 12.|"Patient Perception of Bladder Condition (PPBC) score is rated on a 6-point scale as follows:
No problems at all
Some very minor problems
Some minor problems
Some moderate problems
Severe problems
Many severe problems"|Baseline to Week 12|Full analysis set. No imputation was used for missing data||participants|||Number
751925|NCT00561951|Secondary|Change From Baseline for Patient Perception of Bladder Condition (PPBC) at Week 12.|"Patient Perception of Bladder Condition (PPBC) score is rated on a 6-point scale as follows:
No problems at all
Some very minor problems
Some minor problems
Some moderate problems
Severe problems
Many severe problems
Change: mean at Week 12 minus mean at Baseline."|Baseline to Week 12|Full analysis set. No imputation was used for missing data.||score on scale||Standard Deviation|Mean
751926|NCT00561951|Secondary|Change From Baseline in Each Domain Scores of Overactive Bladder Questionnaire (OAB-q) at Week 12.|"The overactive bladder questionnaire (OAB-q) is used to assess the extent of participants who had been bothered by selected bladder symptoms and to assess the effect on their health-related quality of life (HRQL).
The each domain score ranges from 0 to 100 is a calculated value, where 0=minimal symptom severity and 100=greatest symptom severity for Symptom Bother Score, and where 0=worst HRQL outcome/response and 100=best HRQL outcome/response for HRQL domains including total score of HROL domain.
Change: mean at Week 12 minus mean at Baseline."|Baseline to Week 12|Full analysis set. Half scale rule (domain scores were calculated if a respondent had answered at least half of the items in a multi-item scale. Missing items were then replaced by the mean of non-missing items in that scale, for that participant.)||score on scale||Standard Deviation|Mean
751927|NCT00561951|Secondary|Change From Baseline in Each Domain Scores of King's Health Questionnaire (KHQ).|"King's Health Questionnaire(KHQ) is used to assess the impact of bladder problems on quality of life. The each domain score was calculated valued and ranged from 0 to 100, where 0=best outcome/response and 100=worst outcome/response.
Change: mean at Week 12 minus mean at Baseline."|Baseline to Week12|Full analysis set. No imputation was used for missing data.||score on scale||Standard Deviation|Mean
751928|NCT00561951|Secondary|Change From Baseline in Mean Voided Volume Per Micturition at Weeks 2, 4, 8, and 12.|"Voided volume per micturition was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.
Change: mean at each visit minus mean at Baseline."|Baseline to Weeks 2, 4, 8, and 12|Full analysis set. No imputation was used for missing data.||mL||Standard Deviation|Mean
751929|NCT00561951|Secondary|Change From Baseline in Mean Voided Volume Per Micturition at Week 12.|"Voided volume per micturition was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.
Voided volume was recorded during any 1 day of 3-day diary period through the first micturition of the next day.
Change: mean at Week 12 minus mean at Baseline."|Baseline to Week 12|Full analysis set. Last observation carried forward.||mL||Standard Deviation|Mean
751930|NCT00561951|Secondary|Change From Baseline in Mean Number of Night-Time Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12.|"Number of Night-Time Micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.
Change: mean at each visit minus mean at Baseline."|Baseline to Weeks 2, 4, 8, and 12|"Participants who had mean number of night-time micturitions per 24 hours of greater than 0 at baseline within the full analysis set.
No imputation was used for missing data."||Night-Time Micturitions||Standard Deviation|Mean
751931|NCT00561951|Secondary|Change From Baseline in Mean Number of Night-Time Micturitions Per 24 Hours at Week 12.|"Number of Night-Time Micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.
Change: mean at Week 12 minus mean at Baseline."|Baseline to Week 12|"Among the full analysis set, participants who had mean number of night-time micturitions per 24 hours of greater than 0 at baseline .
Last observation carried forward."||Night-Time Micturitions||95% Confidence Interval|Least Squares Mean
751932|NCT00561951|Secondary|Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 2, 4, 8, and 12.|"Number of incontinence episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.
Incontinence is the complaint of any involuntary leakage of urine.
Change: mean at each visit minus mean at Baseline."|Baseline to Weeks 2, 4, 8, and 12|Full analysis set. No imputation was used for missing data.||Incontinence Episodes||Standard Deviation|Mean
751933|NCT00561951|Secondary|Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Week 12.|"Number of incontinence episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.
Incontinence is the complaint of any involuntary leakage of urine.
Change: mean at Week 12 minus mean at Baseline."|Baseline to Week 12|Full analysis set. Last observation carried forward||Incontinence Episodes||95% Confidence Interval|Least Squares Mean
751934|NCT00561951|Secondary|Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Weeks 2, 4, 8, and 12.|"Number of urgency episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.
Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer.
Change: mean at each visit minus mean at Baseline."|Baseline to Weeks 2, 4, 8, and 12|Full analysis set. No imputation was used for missing data.||Urgency Episodes||Standard Deviation|Mean
751935|NCT00561951|Secondary|Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 12.|"Number of urgency episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.
Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer.
Change: mean at Week 12 minus mean at Baseline."|Baseline to Week 12|Full analysis set. Last observation carried forward.||Urgency Episodes||95% Confidence Interval|Least Squares Mean
751936|NCT00561951|Secondary|Change From Baseline in Mean Number of Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12.|"Number of micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.
Change: mean at each visit minus mean at Baseline."|Baseline to Weeks 2, 4, 8, and 12|Full analysis set. No imputation was used for missing data.||Micturitions||Standard Deviation|Mean
751937|NCT00561951|Secondary|Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12.|"Number of micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.
Change: mean at Week 12 minus mean at Baseline."|Baseline to Week 12|Full analysis set. Last observation carried forward.||Micturitions||95% Confidence Interval|Least Squares Mean
751938|NCT00561951|Secondary|Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 2, 4, 8, and 12.|"Number of urgency urinary incontinence (UUI) episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.
Urgency urinary incontinence is the complaint of involuntary leakage accompanied by or immediately preceded by urgency. Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer.
Change: mean at each visit minus mean at Baseline."|Baseline to Weeks 2, 4, 8, and 12|Full analysis set. No imputation was used for missing data.||UUI Episodes||Standard Deviation|Mean
751939|NCT00561951|Primary|Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12.|"Number of urgency urinary incontinence episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.
Urgency urinary incontinence is the complaint of involuntary leakage accompanied by or immediately preceded by urgency. Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer.
Change: mean at Week 12 minus mean at Baseline."|Baseline to Week 12|Full analysis set. Last observation carried forward.||UUI Episodes||95% Confidence Interval|Least Squares Mean
751940|NCT00561977|Secondary|Change in Calories From Baseline to 6 Months|kilocalories|6 months|||calories||Standard Deviation|Mean
751941|NCT00561977|Secondary|Change in Calories From Baseline to 3 Months|kilocalories|3 months|||calories||Standard Deviation|Mean
751942|NCT00561977|Secondary|Change in Weight From Baseline to 6 Months||6 months|||pounds||Standard Deviation|Mean
751943|NCT00561977|Secondary|Change in Weight From Baseline to 3 Months||3 months|||pounds||Standard Deviation|Mean
751944|NCT00561977|Primary|Dietary Quality, Possible Score From Zero to 80 (Best Quality Diet).|The AHEI consists of 8 components (eg, vegetables,trans fat). Each contributed 0–10 points to the total score; a score of 10 indicates that the recommendations were fully met, whereas a score of 0 represents the least healthy dietary behavior. Intermediate intakes were scored proportionately between 0 and 10. All component scores were summed to obtain a total AHEI score ranging from zero(worst) to 80(best).|3 months|||score||Standard Deviation|Mean
751945|NCT00561977|Primary|Dietary Quality|Dietary quality was measured by the Alternative Healthy Eating Index (AHEI), a scale of healthy eating that goes from zero to 80 (best score).|6 mos|||score||Standard Deviation|Mean
751946|NCT00562094|Secondary|Assessment of the Tolerability of Pantoprazole at Final Visit|Physician's assessment on a scale with 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory|last visit (after a median of 18 days)|Patients included and treated with at least one application of pantoprazole (without imputation of missing values), intention to treat||percentage of participants|||Number
751947|NCT00562094|Secondary|Assessment of the Efficacy of Pantoprazole at Final Visit|Physician's assessment on a scale with 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory|last visit (after a median of 18 days)|Patients included and treated with at least one application of pantoprazole (without imputation of missing values), intention to treat||percentage of participants|||Number
751948|NCT00562094|Secondary|Assessment of the Severity of Sensation of Fullness/Abdominal Distension|Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe|first and last visit (after a median of 18 days)|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat||units on a scale||Standard Deviation|Mean
751949|NCT00562094|Secondary|Assessment of the Severity of Epigastric Complaints/Epigastric Pain|Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe|first and last visit (after a median of 18 days)|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat||units on a scale||Standard Deviation|Mean
751950|NCT00562094|Secondary|Assessment of the Severity of Eructation/Acid Eructation|Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe|first and last visit (after a median of 18 days)|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat||units on a scale||Standard Deviation|Mean
751951|NCT00562094|Secondary|Assessment of the Severity of Heartburn|Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe|first and last visit (after a median of 18 days)|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat||units on a scale||Standard Deviation|Mean
751952|NCT00562094|Primary|Assessment of Change of Quality of Sleep During Therapy With Pantoprazole|"Physician's assessment on a scale with
considerably improved
improved
unchanged"|last visit (after a median of 18 days)|All patients included and treated, intention to treat, missing values not imputed||percentage of participants|||Number
751953|NCT00562094|Primary|Assessment of the Severity of Sleep Disturbances|Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe|first and last visit (after a median of 18 days)|All patients included and treated, intention to treat, missing values not imputed||percentage of participants|||Number
751954|NCT00562120|Other Pre-specified|Serum PF-03654746 Concentration|Only participants receiving PF-03654746 were analyzed for this outcome measure. Mean serum concentration of PF-03654746 was calculated of each intervention period.|1 hr 30 min post dose on Day 1 of each intervention period|Full analysis set included all participants randomized at baseline and who received at least 1 dose of double-blind treatment.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
751955|NCT00562120|Secondary|Nasal Symptom Scores: Sneezing|The absolute number of sneezes was recorded by the participants under supervision of study personnel. Nasal symptom score for sneezing was assessed as the total number of sneezes of each intervention period at specified time-points for the post-diluent and post-challenge and post where ‘post-diluent, pre-allergen challenge’ included 2 hrs 10 min, 2 hrs 25 min and 2 hrs 40 min post PF-03654746/placebo dose at each intervention period and ‘post-allergen challenge’ included 2 hrs 55 min, 3 hrs 10 min and 3 hrs 25 min post PF-03654746/placebo dose at each intervention period.|2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Baseline); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose on Day 1 of each intervention period|Full analysis set included all participants randomized at baseline and who received at least 1 dose of double-blind treatment.||sneezes||Standard Deviation|Mean
751956|NCT00562120|Secondary|Nasal Symptom Scores: Nasal Congestion, Nasal Itching, Rhinorrhea|Nasal symptoms included; nasal congestion: participants rated sensation of nasal blockage on 0 (no blockage) to 5 (total blockage) scale, nasal itching: participants rated sensation of nasal itch on 0 (no itch) to 5 (very itchy) scale, rhinorrhea: participants rated sensation of runny nose on 0 (no running) to 5 (very runny) scale. Symptom scores were assessed as mean of each intervention period at specified time-points for ‘post-diluent, pre-allergen challenge’ measure and ‘post-challenge’ measure. Post-diluent, pre-allergen challenge (for congestion, itching, rhinorrhea) included 2 hrs 10 min, 2 hrs 25 min and 2 hrs 40 min post PF-03654746/placebo dose at each intervention period and post-allergen challenge (for congestion, itching, rhinorrhea) included 2 hrs 55 min, 3 hrs 10 min and 3 hrs 25 min post PF-03654746/placebo dose at each intervention period and (for congestion only) 3 hrs 40 min post PF-03654746/placebo dose (Post-oxymetazoline) at each intervention period.|2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Pre-allergen challenge); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose (Post-allergen challenge); 3 hrs 40 min post dose (Post-oxymetazoline) on Day 1 of each intervention period|Full analysis set included all participants randomized at baseline and who received at least 1 dose of double-blind treatment.||units on a scale||Standard Deviation|Mean
751957|NCT00562120|Secondary|Nasal Volume Maximum Fall Measured Using Acoustic Rhinometry|Acoustic rhinometry: a technique intended for assessment of the geometry of the nasal cavity and nasopharynx and for evaluating nasal obstruction. At each time point, there were 2 acoustic rhinometry measurements taken, one for each nostril. The mean of the left and right nostril measurements was taken as the measurement at each time point. Nasal volume at Baseline was defined as mean of the 3, ‘post-diluent, pre-allergen challenge’ measures for each intervention period at 2 hrs 10 min, 2 hrs 25 min and 2 hrs 40 min post PF-03654746/placebo dose. Nasal volume ‘post-allergen challenge’ measures were recorded at 2 hrs 55 min, 3 hrs 10 min and 3 hrs 25 min post PF-03654746/placebo dose for each intervention period. The maximum fall for nasal volume was calculated as baseline measure minus smallest ‘post-allergen challenge’ nasal volume measurement among the 3 measures.|2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Baseline); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose on Day 1 of each intervention period|Full analysis set included all participants randomized at baseline and who received at least 1 dose of double-blind treatment.||cubic centimeter (cm^3)||Standard Deviation|Mean
751958|NCT00562120|Secondary|Minimum Cross-Sectional Area (Amin) Maximum Fall Measured Using Acoustic Rhinometry|Acoustic rhinometry: a technique intended for assessment of the geometry of the nasal cavity and nasopharynx and for evaluating nasal obstruction. At each time point, there were 2 acoustic rhinometry measurements taken, one for each nostril. The mean of the left and right nostril measurements was taken as the measurement at each time point. Minimum Cross-Sectional Area (Amin) at Baseline was defined as mean of the 3, ‘post-diluent, pre-allergen challenge’ measures for each intervention period at 2 hrs 10 min, 2 hrs 25 min and 2 hrs 40 min post PF-03654746/placebo dose. Amin ‘post-allergen challenge’ measures were recorded at 2 hrs 55 min, 3 hrs 10 min and 3 hrs 25 min post PF-03654746/placebo dose for each intervention period. The maximum fall in Amin was calculated as baseline measure minus smallest ‘post-allergen challenge’ Amin measurement of the 3 measures.|2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Baseline); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose on Day 1 of each intervention period|Full analysis set included all participants randomized at baseline and who received at least 1 dose of double-blind treatment.||square centimeter (cm^2)||Standard Deviation|Mean
751959|NCT00562120|Primary|Nasal Volume Proportion Measured Using Acoustic Rhinometry|Acoustic rhinometry: a technique intended for assessment of the geometry of nasal cavity and nasopharynx and for evaluating nasal obstruction. At each time point, there were 2 acoustic rhinometry measurements taken, one for each nostril. Mean of the left and right nostril measurements was taken as measurement at each time point. Nasal volume at Baseline was defined as mean of 3, ‘post-diluent, pre-allergen challenge’ measures for each intervention period at 2 hrs 10 min, 2 hrs 25 min and 2 hrs 40 min post PF-03654746/placebo dose. Nasal volume ‘post-allergen challenge’ measures recorded at 2 hrs 55 min, 3 hrs 10 min and 3 hrs 25 min post PF-03654746/placebo dose for each intervention period was averaged to derive single ‘post-allergen challenge’ value. Nasal volume proportion was defined as ratio of ‘post-allergen challenge’ value and ‘Baseline/pre-allergen challenge value’. Diluent used was saline and allergen was short ragweed extract.|2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Baseline); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose on Day 1 of each intervention period|Full analysis set included all participants randomized at baseline and who received at least 1 dose of double-blind treatment.||ratio||Standard Deviation|Mean
751960|NCT00562120|Primary|Minimum Cross-Sectional Area (Amin) Proportion Measured Using Acoustic Rhinometry|Acoustic rhinometry: a technique intended for assessment of the geometry of nasal cavity and nasopharynx and for evaluating nasal obstruction. At each time point, there were 2 acoustic rhinometry measurements taken, one for each nostril. Mean of the left and right nostril measurements was taken as measurement at each time point. Minimum Cross-Sectional Area (Amin) at Baseline was defined as mean of 3, ‘post-diluent, pre-allergen challenge’ measures for each intervention period at 2 hours (hrs) 10 minutes (min), 2 hrs 25 min and 2 hrs 40 min post PF-03654746/placebo dose. Amin ‘post-allergen challenge’ measures recorded at 2 hrs 55 min, 3 hrs 10 min and 3 hrs 25 min post PF-03654746/placebo dose for each intervention period was averaged to derive single ‘post-allergen challenge’ value. Amin proportion was defined as ratio of ‘post-allergen challenge’ value and ‘Baseline/pre-allergen challenge value’. Diluent used was saline and allergen was short ragweed extract.|2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Baseline); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose on Day 1 of each intervention period|Full analysis set included all participants randomized at baseline and who received at least 1 dose of double-blind treatment.||ratio||Standard Deviation|Mean
751961|NCT00562159|Secondary|Participant Average Weekly Rhinoconjunctivitis Quality-of-Life Questionnaire With Standardized Activities (RQLQ(S)) Total Score Over the Entire GPS|The RQLQ(s) has 28 questions and focusses on 7 domains that may be significantly impaired in participants with seasonal allergic rhinoconjunctivitis: sleep impairment, non-nasal symptoms, practical problems, nasal symptoms, eye symptoms, activity limitations, and emotional difficulty. The RQLQ score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains. RQLQ scores range from 0-6, with a higher score indicating more significant impairment.|Start of the GPS to End of the GPS|The FAS population was comprised of all participants randomized with at least one post-treatment diary data entry.||Units on a Scale||Standard Deviation|Mean
751962|NCT00562159|Secondary|Participant Average Rhinoconjunctivitis Daily Medication Score (DMS) Over the Entire GPS|The DMS is composed of a sum of the scores associated with rescue medication use per day. Rescue medications were implemented when a participant had a symptom score >= 4. Rescue medications for allergic rhinoconjunctivitis were to be utilized in a step-wise fashion: loratadine, olopatadine hydrochloride 0.1% opthalmic solution, mometasone, and prednisone, in that sequence. The score for the DMS ranged from 0-36. A lower medication score indicated less impact on symptomology and was suggestive of less use of rescue medication.|Start of the GPS to End of the GPS|The FAS population was comprised of all participants randomized with at least one post-treatment diary data entry.||Units on a Scale||Standard Error|Mean
751963|NCT00562159|Secondary|Participant Average Rhinoconjunctivitis Daily Symptom Score (DSS) Over the Entire GPS|The DSS is composed of six rhinoconjunctivitis symptoms which were recorded daily including runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy, and watery eyes, and the symptoms were measured on a scale of 0 (no symptom) to 3 (severe symptoms). A higher score indicated a higher level of symptoms and the total daily score could range from 0 to 18.|Start of the GPS to End of the GPS|The FAS population was comprised of all participants randomized with at least one post-treatment diary data entry.||Units on a Scale||Standard Error|Mean
751964|NCT00562159|Primary|Participant Total Combined Symptom (TCS) Score Over the Entire Grass Pollen Season (GPS)|The TCS is the sum of the rhinoconjunctivitis daily symptom score (DSS) and rhinoconjunctivitis daily medication score (DMS) averaged over the entire GPS. The TCS ranged from 0-54, with increasing score indicating a higher level of symptom severity. The DSS is composed of 6 rhinoconjunctivitis symptoms with scores from 0-18, with increasing score indicating increased severity. The DMS is composed of a sum of the scores associated with rescue medication use per day. The range for the DMS was 0-36, with a lower score indicating less use of rescue medication.|Start of the GPS to End of the GPS|The full analysis set (FAS) population was comprised of all participants randomized with at least one post-treatment diary data entry.||Units on a Scale||Standard Error|Mean
751965|NCT00562302|Secondary|Incidence of Adverse Events|Any treatment emergent adverse events (not considered device related by the investigators).|30 days|Intent to Treat Population||participants|||Number
751966|NCT00562302|Secondary|Participants Discharged Beyond Hospital's Standard of Care|Current standard of care for hospital discharge varies. Some institutions allow the patient to be discharged after a 3 hour wait. Others allow discharge after an x-ray indicates no pneumothorax. Since this study was randomized with control patients, the time to discharge beyond the hospital’s standard of care was recorded to see if a trend for later discharge was apparent. This measure indicates the number of participants who were discharged later than their hospital's standard of care.|30-day|Intent to Treat Population||participants|||Number
751967|NCT00562302|Secondary|Number of Participants With Additional Chest X-rays Needed||30 day|Intent to Treat Population||participants|||Number
751968|NCT00562302|Secondary|Incidence of Adverse Events Related to the Procedure and Device Effects|Anticipated, device-related adverse events that were defined in the original protocol.|30 Day|Intent to Treat Patients||participants|||Number
751969|NCT00562302|Secondary|Incidence of Hospital Admissions for Pneumothorax||30 day|Intent to treat Population||participants|||Number
751970|NCT00562302|Secondary|Time to Ambulation||30 days|Intent to Treat Population||Hours||Standard Deviation|Mean
751971|NCT00562302|Secondary|Incidence of Chest Tube Placement|A chest tube is the definitive initial treatment of a pneumothorax.|30 days|Intent to treat Population||participants|||Number
751972|NCT00562302|Primary|Incidence Rate of Treatment Success|Treatment success was defined as the absence of a pneumothorax at each of the three follow-up time periods (0-60 minutes, 24 hours and 30 days).|30 days|Per Protocol Population||participants|||Number
751973|NCT00562315|Secondary|Diagnostic Performance of ProstaScint Imaging in Detection of Extra-prostatic Recurrence of Prostate Carcinoma|"Sensitivity = How well ProstaScint is able to correctly detect when there is prostate cancer outside the prostate bed. [total number of true positives / total number of study participants confirmed to have prostate cancer outside the prostate bed (True positives + False negatives)]
Specificity = How well ProstaScint is able to correctly detect when there is no prostate cancer outside the prostate bed. [ total number of true negatives / total number of study participants confirmed to not have prostate cancer outside the prostate bed (True negatives + False positives)]
Accuracy = (True positives + true negatives)/all tests
Positive predictive value = the probability that subjects with a positive screening test truly have prostate cancer outside the prostate bed
Negative predictive value is the probability that subjects with a negative screening test truly don't have prostate cancer outside the prostate bed"|Up to 5 years|Participants with a definitive consensus for the presence or absence of extraprostatic disease.||percentage of true tests||95% Confidence Interval|Number
751974|NCT00562315|Secondary|Diagnostic Performance of ProstaScint Imaging in Detection of Recurrent Prostate Carcinoma in the Prostate Bed|"Sensitivity = How well ProstaScint imaging is able to correctly detect when there is prostate cancer in the prostate bed. i.e. total number of true positives / total number of study participants confirmed to have prostate disease in the prostate bed (True positives + False negatives)
Specificity = How well ProstaScint imaging is able to correctly detect when there is no prostate cancer in the prostate bed. i.e. total number of true negatives / total number of study participants confirmed to not have prostate disease in the prostate bed (True negatives + False positives)
Accuracy = (True positives + true negatives)/all tests
Positive predictive value = the probability that subjects with a positive screening test truly have prostate carcinoma in the prostate bed
Negative predictive value = the probability that subjects with a negative screening test truly don't have prostate carcinoma in the prostate bed"|Up to 5 years|Participants with a definitive consensus on the presence or absence of prostatic/bed disease.||percentage of true tests||95% Confidence Interval|Number
751990|NCT00562328|Primary|Proportion of Confirmed Responses (Complete or Partial Response Noted as the Objective Status for a Duration of at Least 2 Months) at 6 Months|"Response, as defined by the National Cancer Institute Working Group (NCIWG), requires the following for a period of at least 2 months:
CR: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count; confirmed by bone marrow (BM) aspirate & biopsy
PR: 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence/absence of constitutional symptoms; plus ≥1 of the following: ≥1500/μL polymorphonuclear leukocytes, >100,000/μL platelets, >11.0 g/dL hemoglobin or 50% improvement for these parameters without transfusions"|6 months|||participants|||Number
751975|NCT00562315|Primary|Diagnostic Performance of Anti-[18F]FACBC PET-CT Imaging in Detection of Recurrent Prostate Carcinoma in the Prostate Bed|"Sensitivity = How well FACBC PET is able to correctly detect when there is prostate cancer in the prostate bed. i.e. total number of true positives / total number of study participants confirmed to have prostate disease in the prostate bed (True positives + False negatives)
Specificity = How well FACBC PET is able to correctly detect when there is no prostate cancer in the prostate bed. i.e. total number of true negatives / total number of study participants confirmed to not have prostate disease in the prostate bed (True negatives + False positives)
Accuracy = (True positives + true negatives)/all tests
Positive predictive value = the probability that subjects with a positive screening test truly have prostate carcinoma in the prostate bed
Negative predictive value = the probability that subjects with a negative screening test truly don't have prostate carcinoma in the prostate bed"|Up to 5 years|Participants with a definitive consensus on the presence or absence of prostatic/bed disease.||percentage of true tests||95% Confidence Interval|Number
751976|NCT00562315|Primary|Diagnostic Performance of Anti-[18F]FACBC PET-CT Imaging in Detection of Extra-prostatic Recurrence of Prostate Carcinoma|"Sensitivity = How well FACBC PET is able to correctly detect when there is prostate cancer outside the prostate bed. [total number of true positives / total number of study participants confirmed to have prostate cancer outside the prostate bed (True positives + False negatives)]
Specificity = How well FACBC PET is able to correctly detect when there is no prostate cancer outside the prostate bed. [ total number of true negatives / total number of study participants confirmed to not have prostate cancer outside the prostate bed (True negatives + False positives)]
Accuracy = (True positives + true negatives)/all tests
Positive predictive value = probability that subjects with a positive screening test truly have prostate cancer outside the prostate bed
Negative predictive value = probability that subjects with a negative screening test truly don't have prostate cancer outside the prostate bed"|Up to 5 years|Participants with a definitive consensus for the presence or absence of extraprostatic disease.||percentage of true tests||95% Confidence Interval|Number
751977|NCT00562315|Primary|Number of Participants With False Negative Scans Outside the Prostate Bed|Total number of participants with negative FACBC PET-CT and ProstaScint CT scans outside the prostate bed (extra-prostate) that were confirmed as positive by biopsy and/or follow up.|Up to 5 years|There was sufficient data for 70 participants to determine disease presence or absence at extraprostatic locations.||participants|||Number
751978|NCT00562315|Primary|Number of Participants With False Positive Scans Outside the Prostate Bed|Total number of participants with positive FACBC PET-CT and ProstaScint CT scans outside the prostate bed (extra-prostate) that were confirmed as negative by biopsy and/or follow up.|Up to 5 years|There was sufficient data for 70 participants to determine disease presence or absence at extraprostatic locations.||participants|||Number
751979|NCT00562315|Primary|Number of Participants With True Negative Scans Outside the Prostate Bed|Total number of participants with negative FACBC PET-CT and ProstaScint CT scans outside the prostate bed (extra-prostate) that were confirmed as negative by biopsy and/or follow up.|Up to 5 years|There was sufficient data for 70 participants to determine disease presence or absence at extraprostatic locations.||participants|||Number
751980|NCT00562315|Primary|Number of Participants With True Positive Scans Outside the Prostate Bed|Total number of participants with positive FACBC PET-CT and ProstaScint CT scans outside the prostate bed (extra-prostate) that were confirmed as positive by biopsy and/or follow up.|Up to 5 years|There was sufficient data for 70 participants to determine disease presence or absence at extraprostatic locations.||participants|||Number
751981|NCT00562315|Primary|Number of Participants With False Negative Scans Within the Prostate Bed|Total number of participants with negative FACBC PET-CT and ProstaScint CT scans in the prostate bed that were confirmed as positive by biopsy and or follow up.|Up to 5 years|91 participants had sufficient data to determine disease presence or absence in the prostate bed.||participants|||Number
751982|NCT00562315|Primary|Number of Participants With True Negative Scans Within the Prostate Bed|Total number of participants with negative FACBC PET-CT and ProstaScint CT scans in the prostate bed that were confirmed as negative by biopsy and or follow up.|Up to 5 years|91 participants had sufficient data to determine disease presence or absence in the prostate bed.||participants|||Number
751983|NCT00562315|Primary|Number of Participants With False Positive Scans Within the Prostate Bed|Total number of participants with positive FACBC PET-CT and ProstaScint scans in the prostate bed that were confirmed as negative by biopsy and or follow up.|Up to 5 years|91 participants had sufficient data to determine disease presence or absence in the prostate bed.||participants|||Number
751984|NCT00562315|Primary|Number of Participants With True Positive Scans Within the Prostate Bed|Total number of participants with positive FACBC PET-CT and ProstaScint CT scans in diagnosis of prostate cancer in the prostate bed validated by prostate biopsy and follow up.|Up to 5 years|91 participants had sufficient data to determine disease presence or absence in the prostate bed.||participants|||Number
751985|NCT00562328|Secondary|Time to Subsequent Therapy|Time to subsequent treatment (TTS) was defined as the time from end of active (protocol) treatment to the start of subsequent treatment. The median TTS with 95% CI was estimated using the Kaplan Meier method.|time from end of protocol treatment to subsequent treatment (up to 5 years)||||||
751986|NCT00562328|Secondary|Overall Survival|Overall Survival (OS) was defined as the time from registration to death of any cause. Participants were followed for a maximum of 5 years from registration. The median OS with 95% CI was estimated using the Kaplan Meier method.|Time from registration to death (up to 5 years)||||||
751987|NCT00562328|Secondary|Duration of Response|Duration of response (DOR) is defined as the time from documentation of response (CR or PR) to disease progression. The median DOR with 95% CI was estimated using the Kaplan Meier method.|time from start of response to progression (up to 5 years)||||||
751988|NCT00562328|Secondary|Time to Response|Time to response (TTR) is defined as the time from registration to first documentation of response (CR or PR). In participants who do not achieve a response, time will be censored at the participants last evaluation (for disease) date. The median TTR with 95% CI was estimated using the Kaplan Meier method.|time from registration to first documentation of response (up to 5 years)||||||
751989|NCT00562328|Secondary|Time to Disease Progression|Time to disease progression (TTP) was defined as the time from registration to the earliest date documentation of disease progression. Participants were followed for a maximum of 5 years from registration. The median OS with 95% confidence interval (CI) was estimated using the Kaplan Meier method.|Time from registration to progression (up to 5 years)||||||
751991|NCT00562354|Secondary|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years|Systemic events reported using electronic diary. Fever scaled as Any (≥37.5 degrees Celsius [C]); Mild (≥37.5 but <38.5 degrees C); Moderate (≥38.5 but <39 degrees C); Severe (≥39 to ≤40 degrees C); Potentially life-threatening (>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New muscle pain, Any aggravated muscle pain, New joint pain, and Any aggravated joint pain.|Day 1 through 14|Safety population included all participants who received the study treatment. N=number of participants with analyzable data for reactogenicity events. Participants may be represented in more than 1 category.||percentage of participants|||Number
751992|NCT00562354|Secondary|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Overall Population|Systemic events reported using electronic diary. Fever scaled as Any (≥37.5 degrees Celsius [C]); Mild (≥37.5 but <38.5 degrees C); Moderate (≥38.5 but <39 degrees C); Severe (≥39 to ≤40 degrees C); Potentially life-threatening (>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New muscle pain, Any aggravated muscle pain, New joint pain, and Any aggravated joint pain.|Day 1 through 14|Safety population included all participants who received the study treatment. N=number of participants with analyzable data for reactogenicity events. Participants may be represented in more than 1 category.||percentage of participants|||Number
751993|NCT00562354|Secondary|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years|Local reactions reported using electronic diary. Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters [cm] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (> 10.0 cm). Pain as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move above shoulder).|Day 1 through 14|Safety population included all participants who received the study treatment. N=number of participants with analyzable data for reactogenicity events. Participants may be represented in more than 1 category.||percentage of participants|||Number
751994|NCT00562354|Secondary|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Overall Population|Local reactions reported using electronic diary. Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters [cm] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (> 10.0 cm). Pain as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move above shoulder).|Day 1 through 14|Safety population included all participants who received the study treatment. N=number of participants with analyzable data for reactogenicity events. Participants may be represented in more than 1 category.||percentage of participants|||Number
751995|NCT00562354|Secondary|Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years|Geometric mean fold rises (GMFRs) for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results. CI for the GMFRs are back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.|1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with valid and determinate assay results for the specified serotype at both blood draws. GMFRs calculated using all participants with available data from both the prevaccination and postvaccination blood draws.||fold rise||95% Confidence Interval|Geometric Mean
751996|NCT00562354|Secondary|Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Overall Population|Geometric mean fold rises (GMFRs) for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results. CI for the GMFRs are back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.|1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with valid and determinate assay results for the specified serotype at both blood draws. GMFRs calculated using all participants with available data from both the prevaccination and postvaccination blood draws.||fold rise||95% Confidence Interval|Geometric Mean
751997|NCT00562354|Secondary|Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination by Age Group|Serotype-specific IgG antibody concentrations for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F), as measured by enzyme-linked immunosorbent assay (ELISA). IgG concentrations will be logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean concentration (GMC) in micrograms per mL (mcg/mL). The 2-sided, 95% CIs on the GMCs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with determinate antibody concentration for the specified serotype. GMCs calculated using all participants with available data for the specified blood draw.||mcg/mL||95% Confidence Interval|Geometric Mean
751998|NCT00562354|Secondary|Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years|Serotype-specific IgG antibody concentrations for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F), as measured by enzyme-linked immunosorbent assay (ELISA). IgG concentrations will be logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean concentration (GMC) in micrograms per mL (mcg/mL). The 2-sided, 95% CIs on the GMCs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with valid and determinate assay results for the specified serotype at both blood draws. GMCs calculated using all participants with available data for both the specified blood draws.||mcg/mL||95% Confidence Interval|Geometric Mean
751999|NCT00562354|Secondary|Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Overall Population|Serotype-specific IgG antibody concentrations for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F), as measured by enzyme-linked immunosorbent assay (ELISA). IgG concentrations will be logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean concentration (GMC) in micrograms per mL (mcg/mL). The 2-sided, 95% CIs on the GMCs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with valid and determinate assay results for the specified serotype at both blood draws. GMCs calculated using all participants with available data for both the specified blood draws.||mcg/mL||95% Confidence Interval|Geometric Mean
752000|NCT00562354|Secondary|Comparison of Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group|For each serotype the proportion (percentage of participants) achieving at least a 4-fold rise on the serotype-specific antibody titer from prevaccination to 1 month postvaccination was computed along with exact, 2-sided 95% confidence interval for the proportion.|1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with determinate postvaccination OPA antibody titers to the given serotype.||percentage of participants||95% Confidence Interval|Number
752001|NCT00562354|Secondary|Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years|For each serotype the proportion (percentage of participants) achieving at least a 4-fold rise on the serotype-specific antibody titer from prevaccination to 1 month postvaccination was computed along with exact, 2-sided 95% confidence interval for the proportion.|1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with determinate postvaccination OPA antibody titers to the given serotype.||percentage of participants||95% Confidence Interval|Number
752002|NCT00562354|Secondary|Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population|For each serotype the proportion (percentage of participants) achieving at least a 4-fold rise on the serotype-specific antibody titer from prevaccination to 1 month postvaccination was computed along with exact, 2-sided 95% confidence interval for the proportion.|1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with determinate postvaccination OPA antibody titers to the given serotype.||percentage of participants||95% Confidence Interval|Number
752003|NCT00562354|Secondary|Comparison of Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group|For each serotype the proportion (percentage of participants) achieving at least a 2-fold rise on the serotype-specific antibody titer from prevaccination to 1 month postvaccination was computed along with exact, 2-sided 95% confidence interval for the proportion.|1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with determinate postvaccination OPA antibody titers to the given serotype.||percentage of participants||95% Confidence Interval|Number
752004|NCT00562354|Secondary|Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years|For each serotype the proportion (percentage of participants) achieving at least a 2-fold rise on the serotype-specific antibody titer from prevaccination to 1 month postvaccination was computed along with exact, 2-sided 95% confidence interval for the proportion.|1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with determinate postvaccination OPA antibody titers to the given serotype.||percentage of participants||95% Confidence Interval|Number
752005|NCT00562354|Secondary|Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population|For each serotype the proportion (percentage of participants) achieving at least a 2-fold rise on the serotype-specific antibody titer from prevaccination to 1 month postvaccination was computed along with exact, 2-sided 95% confidence interval for the proportion.|1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with determinate postvaccination OPA antibody titers to the given serotype.||percentage of participants||95% Confidence Interval|Number
752006|NCT00562354|Secondary|Comparison of Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination by Age Group|For OPA assays serotype-specific lower limit of quantitation (LLOQ) was derived the 13 serotypes: serotype 1=18; 3=12; 4=21; 5=29; 6A=37; 6B=43; 7F=210; 9V=345; 14=35; 18C=31; 19A=18; 19F=48; 23F=13. For each serotype the proportion (percentage of participants) achieving an OPA titer of at least 1:LLOQ was computed along with exact, 2-sided 95% confidence interval for the proportion.|1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with determinate postvaccination OPA antibody titers to the given serotype.||percentage of participants||95% Confidence Interval|Number
752007|NCT00562354|Secondary|Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years|For OPA assays serotype-specific lower limit of quantitation (LLOQ) was derived the 13 serotypes: serotype 1=18; 3=12; 4=21; 5=29; 6A=37; 6B=43; 7F=210; 9V=345; 14=35; 18C=31; 19A=18; 19F=48; 23F=13. For each serotype the proportion (percentage of participants) achieving an OPA titer of at least 1:LLOQ was computed along with exact, 2-sided 95% confidence interval for the proportion.|1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with determinate postvaccination OPA antibody titers to the given serotype.||percentage of participants||95% Confidence Interval|Number
752008|NCT00562354|Secondary|Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Overall Population|For OPA assays serotype-specific lower limit of quantitation (LLOQ) was derived the 13 serotypes: serotype 1=18; 3=12; 4=21; 5=29; 6A=37; 6B=43; 7F=210; 9V=345; 14=35; 18C=31; 19A=18; 19F=48; 23F=13. For each serotype the proportion (percentage of participants) achieving an OPA titer of at least 1:LLOQ was computed along with exact, 2-sided 95% confidence interval for the proportion.|1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with determinate postvaccination OPA antibody titers to the given serotype.||percentage of participants||95% Confidence Interval|Number
752009|NCT00562354|Secondary|Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination by Age Group|Serotype-specific antibody-mediated opsonophagocytic activity (functional antibodies) for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) as measured by a quantitative opsonophagocytic activity assay (OPA). OPA titers will be logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs). The 2-sided, 95% CIs on the GMTs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with determinate antibody titers for the specified serotype. GMTs calculated using all participants with available data for the specified blood draw.||titer||95% Confidence Interval|Geometric Mean
752010|NCT00562354|Primary|Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years|Geometric mean fold rises (GMFRs) for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results. CI for the GMFRs are back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.|Prevaccination (Day 1), 1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with valid and determinate assay results for the specified serotype at both blood draws. GMFRs calculated using all participants with available data from both the prevaccination and postvaccination blood draws.||fold rise||95% Confidence Interval|Geometric Mean
752011|NCT00562354|Primary|Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Overall Population|Geometric mean fold rises (GMFRs) for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results. CI for the GMFRs are back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.|Prevaccination (Day 1), 1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with valid and determinate assay results for the specified serotype at both blood draws. GMFRs calculated using all participants with available data from both the prevaccination and postvaccination blood draws.||fold rise||95% Confidence Interval|Geometric Mean
752012|NCT00562354|Primary|Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years|Serotype-specific antibody-mediated opsonophagocytic activity (functional antibodies) for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) as measured by a quantitative opsonophagocytic activity assay (OPA). OPA titers will be logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs). The 2-sided, 95% CIs on the GMTs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with valid and determinate assay results for the specified serotype at both blood draws.||titer||95% Confidence Interval|Geometric Mean
752013|NCT00562354|Primary|Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Overall Population|Serotype-specific antibody-mediated opsonophagocytic activity (functional antibodies) for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) as measured by a quantitative opsonophagocytic activity assay (OPA). OPA titers will be logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs). The 2-sided, 95% confidence intervals (CIs) on the GMTs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|1 month after vaccination|Evaluable Immunogenicity population: treatments as randomized at all expected doses, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations. N=number of participants with valid and determinate assay results for the specified serotype at both blood draws.||titer||95% Confidence Interval|Geometric Mean
752014|NCT00562484|Secondary|New Onsets of Chronic Illness (NOCI)|An NOCI was defined as the diagnosis of a chronic medical condition where the symptoms commenced or worsened following exposure to study vaccine and may have included those potentially controllable by medication (e.g., glaucoma, hypertension).|180 days after study vaccination|Safety Population comprised all participants who received study vaccine (CSL's IVV or placebo) and provided at least one safety assessment after the vaccination.||Participants|||Number
752015|NCT00562484|Secondary|Serious Adverse Events (SAEs)|"An SAE was any untoward medical occurrence that at any dose:
Resulted in death;
Was life-threatening;
Required an unexpected in-participant hospitalization or prolongation of existing hospitalization;
Resulted in persistent or significant disability / incapacity;
Was a congenital anomaly / birth defect; and / or
Was medically significant (defined as an event that did not necessarily meet any of the SAE criteria, but was judged by the treating physician to potentially jeopardize the participant or require medical intervention to prevent one of the out"|180 days after study vaccination|Safety Population comprised all participants who received study vaccine (CSL's IVV or placebo) and provided at least one safety assessment after the vaccination.||Participants|||Number
752016|NCT00562484|Secondary|Frequency and Intensity of Unsolicited Adverse Events (UAEs)|"UAE grading:
Grade 1 (mild): Symptoms were easily tolerated and did not interfere with daily activities.
Grade 2 (moderate): Discomfort was enough to cause some interference with daily activities.
Grade 3 (severe): Symptoms that prevented normal, everyday activities."|21 days after study vaccination|Safety Population comprised all participants who received study vaccine (CSL's IVV or placebo) and provided at least one safety assessment after the vaccination.||Participants|||Number
752017|NCT00562484|Secondary|Frequency and Intensity of Local and Systemic Solicited Symptoms|"Adverse event grading:
Grade 1 (mild): Symptoms were easily tolerated and did not interfere with daily activities.
Grade 2 (moderate): Discomfort was enough to cause some interference with daily activities.
Grade 3 (severe): Symptoms that prevented normal, everyday activities.
Fever Grade 1: ≥ 37.7°C - < 38.0°C (≥ 99.9 - < 100.4°F) Grade 2: ≥ 38.0°C - < 39.0°C (≥ 100.4 - < 102.2°F) Grade 3: ≥ 39.0°C (> 102.2°F)"|5 days after study vaccination|Safety Population comprised all participants who received study vaccine (CSL’s IVV or placebo) and provided at least one safety assessment after the vaccination.||Participants|||Number
752018|NCT00562484|Secondary|Geometric Mean Fold Increase in HI Titer Rate 21 Days After Study Vaccination, Year 2009|Geometric mean fold increase in HI titer was defined as the geometric mean titer (GMT) after vaccination divided by the GMT before vaccination.|21 days after study vaccination|Evaluable Population for the Clinical Endpoint Analysis consisted of all participants who: received study vaccine and clinical endpoint follow-up was longer than 14 days after vaccination; and had not taken any contraindicated medications during the On-study or Clinical Endpoint Periods as potentially impacting clinical endpoint assessments.||Fold increase||95% Confidence Interval|Number
752019|NCT00562484|Secondary|Geometric Mean Fold Increase in HI Titer 21 Days After Study Vaccination, Year 2008|Geometric mean fold increase in HI titer was defined as the geometric mean titer (GMT) after vaccination divided by the GMT before vaccination.|21 days after study vaccination|Evaluable Population for the Clinical Endpoint Analysis consisted of all participants who: received study vaccine and clinical endpoint follow-up was longer than 14 days after vaccination; and had not taken any contraindicated medications during the On-study or Clinical Endpoint Periods as potentially impacting clinical endpoint assessments.||Fold increase||95% Confidence Interval|Number
752020|NCT00562484|Secondary|Percentage of Participants With Seroconversion 21 Days After Study Vaccination, Year 2009|Seroconversion rate: defined as the percentage of participants with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and a minimum four-fold rise in post-vaccination HI antibody titer.|21 days after study vaccination|Evaluable Population for the Clinical Endpoint Analysis consisted of all participants who: received study vaccine and clinical endpoint follow-up was longer than 14 days after vaccination; and had not taken any contraindicated medications during the On-study or Clinical Endpoint Periods as potentially impacting clinical endpoint assessments.||Percentage of participants||95% Confidence Interval|Number
752021|NCT00562484|Secondary|Percentage of Participants With Seroconversion 21 Days After Study Vaccination, Year 2008|Seroconversion rate: defined as the percentage of participants with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and a minimum four-fold rise in post-vaccination HI antibody titer.|21 days after study vaccination|Evaluable Population for the Clinical Endpoint Analysis consisted of all participants who: received study vaccine and clinical endpoint follow-up was longer than 14 days after vaccination; and had not taken any contraindicated medications during the On-study or Clinical Endpoint Periods as potentially impacting clinical endpoint assessments.||Percentage of participants||95% Confidence Interval|Number
752022|NCT00562484|Secondary|Percentage of Participants With a Minimum Post-vaccination Hemagglutination Inhibition (HI) Titer of 1:40, Year 2009||21 days after study vaccination|Evaluable Population for the Clinical Endpoint Analysis consisted of all participants who: received study vaccine and clinical endpoint follow-up was longer than 14 days after vaccination; and had not taken any contraindicated medications during the On-study or Clinical Endpoint Periods as potentially impacting clinical endpoint assessments.||Percentage of participants||95% Confidence Interval|Number
752023|NCT00562484|Secondary|Percentage of Participants With a Minimum Post-vaccination Hemagglutination Inhibition (HI) Titer of 1:40, Year 2008||21 days after study vaccination|Evaluable Population for the Clinical Endpoint Analysis consisted of all participants who: received study vaccine and clinical endpoint follow-up was longer than 14 days after vaccination; and had not taken any contraindicated medications during the On-study or Clinical Endpoint Periods as potentially impacting clinical endpoint assessments.||Percentage of participants||95% Confidence Interval|Number
752024|NCT00562484|Secondary|Incidence of Influenza-like Illness (ILI)|"The criteria for the protocol defined ILI were as follows:
At least one respiratory symptom:
cough, sore throat or nasal congestion
And at least one systemic symptom:
fever (as defined by oral temperature ≥ 37.8°C (100.0°F), or feverishness (as defined by participant’s subjective feeling of fever), chills or body aches.
The CDC ILI case definition was the occurrence of fever (100°F [37.8°C] or higher) in conjunction with either cough or sore throat."|2008 and 2009 Southern Hemisphere influenza seasons, until 30 November 2009|Evaluable Population for the Clinical Endpoint Analysis consisted of all participants who: received study vaccine and clinical endpoint follow-up was longer than 14 days after vaccination; and had not taken any contraindicated medications during the On-study or Clinical Endpoint Periods as potentially impacting clinical endpoint assessments.||Percentage of participants|||Number
752025|NCT00562484|Secondary|CSL's IVV Vaccine Efficacy Versus Placebo Through Assessment of Incidence of Laboratory Confirmed Influenza A/B Infection Due to Strains Matched to Vaccine Strains|"Incidence of laboratory confirmed influenza A/B infection due to strains matched to vaccine strains was assessed per the study population in the 2008 and 2009 Southern Hemisphere influenza seasons.
Vaccine efficacy = 100 x (1 - ratio of incidence rate). Ratio of incidence rate = active Study Vaccine recipient infection rate / Placebo recipient infection rate."|2008 and 2009 Southern Hemisphere influenza seasons, until 30 November 2009|Evaluable Population for the Clinical Endpoint Analysis consisted of all participants who: received study vaccine and clinical endpoint follow-up was longer than 14 days after vaccination; and had not taken any contraindicated medications during the On-study or Clinical Endpoint Periods as potentially impacting clinical endpoint assessments.||Ratio||95% Confidence Interval|Number
752026|NCT00562484|Primary|CSL's IVV Overall Vaccine Efficacy (VE) Versus Placebo Through Assessment of Incidence of Laboratory Confirmed Influenza A/B Infection|"Incidence of Laboratory Confirmed Influenza A/B infection was assessed per the study population in the 2008 and 2009 Southern Hemisphere influenza seasons.
Vaccine efficacy = 100 x (1 - ratio of incidence rate). Ratio of incidence rate = active Study Vaccine recipient infection rate / placebo recipient infection rate."|2008 and 2009 Southern Hemisphere influenza seasons, until 30 November 2009|Evaluable Population for the Clinical Endpoint Analysis consisted of all participants who: received study vaccine and clinical endpoint follow-up was longer than 14 days after vaccination; and had not taken any contraindicated medications during the On-study or Clinical Endpoint Periods as potentially impacting clinical endpoint assessments.||Ratio||95% Confidence Interval|Number
752027|NCT00562588|Secondary|Change From Baseline in DWI (Diffuse-Weighted Imaging) at Day 90|MRI was performed to assess growth in stroke lesion volume by diffusion-weighted imaging (DWI). DWI was to give evidence of the development of the ischaemic lesion corresponding to the evolved stroke.|Baseline and day 90|Full Analysis Set - included all randomised patients who had value in DWI at baseline and day 90.||mL||Inter-Quartile Range|Median
755301|NCT00593606|Primary|Change in Total Protein|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||g/dl||Standard Deviation|Mean
752028|NCT00562588|Secondary|Change From Baseline in DWI (Diffuse-Weighted Imaging) at Day 8|MRI was performed to assess growth in stroke lesion volume by diffusion-weighted imaging (DWI). DWI was to give evidence of the development of the ischaemic lesion corresponding to the evolved stroke.|Baseline and day 8|Full Analysis Set - included all randomised patients who had value in DWI at baseline and day 8.||mL||Inter-Quartile Range|Median
752029|NCT00562588|Secondary|Change From Baseline in FLAIR (Fluid-Attenuated Inversion Recovery) at Day 90.|MRI was performed to assess growth in stroke lesion volume by fluid-attenuated inversion recovery (FLAIR).|Baseline and day 90|Full Analysis Set - included all randomised patients who had value in FLAIR at baseline and day 90.||mL||Inter-Quartile Range|Median
752030|NCT00562588|Secondary|Change From Baseline in FLAIR (Fluid-Attenuated Inversion Recovery) at Day 8|MRI was performed to assess growth in stroke lesion volume by fluid-attenuated inversion recovery (FLAIR).|Baseline and day 8|Full Analysis Set - included all randomised patients who had value in FLAIR at baseline and day 8.||mL||Inter-Quartile Range|Median
752031|NCT00562588|Secondary|Change of Special Biochemical Laboratory Value - MCP-1|Changes of special biochemical laboratory value (MCP-1) from baseline to day 8 - centralised, blinded assessment by a specialised central clinical laboratory|8 days|FAS which included all randomised patients who had follow up data available (mRS or NIHSS) or who were dead.||µg/mL||95% Confidence Interval|Geometric Mean
752032|NCT00562588|Secondary|Change of Special Biochemical Laboratory Value- MMP-9|Changes of special biochemical laboratory value (MMP-9) from baseline to day 8 - centralised, blinded assessment by a specialised central clinical laboratory|8 days|FAS which included all randomised patients who had follow up data available (mRS or NIHSS) or who were dead.||ng/mL||95% Confidence Interval|Geometric Mean
752033|NCT00562588|Secondary|Change of Special Biochemical Laboratory Value- CRP|Changes of special biochemical laboratory values (CRP) from baseline to day 8 - centralised, blinded assessment by a specialised central clinical laboratory|8 days|FAS which included all randomised patients who had follow up data available (mRS or NIHSS) or who were dead.||mg/L||95% Confidence Interval|Geometric Mean
752034|NCT00562588|Secondary|Change From Baseline in NIHSS (National Institutes of Health Stroke Scale) at Day 8|The NIHSS is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42 (dead)|Baseline and 8 days|FAS which included all randomised patients who had follow up data available (mRS or NIHSS) or who were dead.||units on a scale||Inter-Quartile Range|Median
752035|NCT00562588|Secondary|Telephone Modified Rankin Scale (Centralised, Blinded Assessment) at Day 8|The modified Rankin Scale (mRS) is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke. The scale runs from 0-6, running from perfect health without symptoms to death. Best value - 0 (No symptoms), worst value - 6 (Dead)|8 days|FAS which included all randomised patients who had follow up data available (mRS or NIHSS) or who were dead.||participants|||Number
752036|NCT00562588|Secondary|Patients With Relevant Event (Death, Non-fatal Stroke, Transient Ischaemic Attack (TIA), Myocardial Infarction (MI), Bleeding)||90 days|FAS which included all randomised patients who had follow up data available (mRS or NIHSS) or who were dead.||participants|||Number
752037|NCT00562588|Secondary|Change From Baseline in NIHSS (National Institutes of Health Stroke Scale)|The NIHSS is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42 (dead)|Baseline and 90 days|FAS which included all randomised patients who had follow up data available (mRS or NIHSS) or who were dead.||Units on a scale||Inter-Quartile Range|Median
752038|NCT00562588|Primary|Telephone Modified Rankin Scale (Centralised, Blinded Assessment)|The modified Rankin Scale (mRS) is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke. The scale runs from 0-6, running from perfect health without symptoms to death. Best value - 0 (No symptoms), worst value - 6 (Dead)|90 days|FAS which included all randomised patients who had follow up data available (mRS or NIHSS) or who were dead.||participants|||Number
752039|NCT00562627|Secondary|Time to Readiness for Discharge|Each postoperative day, discharge readiness was assessed by an orthopaedic surgeon, a pain nurse, a ward nurse, and a physiotherapist according to the following criteria: no evidence for surgical complications, VAS pain at rest ≤30 mm which is controlled by oral analgesics, ability to eat and drink, ability to walk with elbow crutches, and ability to climb ≥8 stairs.|up to 10 days postoperative|||days||Standard Deviation|Mean
752040|NCT00562627|Primary|Pain at Rest (VAS)|VAS (pain at rest) 0-100 mm. VAS 0 mm means no pain and VAS 100 mm means maximal pain.|48 hours postoperative|||Units on a scale||Standard Deviation|Mean
752041|NCT00562627|Secondary|Opioid Use|Morphine used by patient controlled analgesia. Amount of used morphine during the first 48 hours after surgery were documented in the CRF by the pain nurses.|48 hours postoperative|||mg||Standard Deviation|Mean
752042|NCT00562861|Primary|MADRS Rating Scale Change|Montgomery Asberg Depression Rating scale assessed in mixed effects regression model. The total range for the scale is 0 to 60. Lower values involve less depression, while higher values involve worse depression. The change in the MADRS scale is interpreted as higher values meaning better outcomes, because more depressive symptoms are improved.|6 weeks|All patients randomized were analyzed in intent to treat manner.||units on a scale||Standard Deviation|Mean
752043|NCT00563290|Secondary|COX-2 Presence by IHC|Performed per standard protocols by the Pathology Department. Samples will be obtained pre-therapy. Determination of the COX-2 tumor status on this trial will develop the beginnings of a data base upon which future therapy may be designed.|At baseline|Funding was not available to do correlative studies|||||
752044|NCT00563290|Secondary|Presence of Total EphA2 and Both Total and Active Src and FAK by Immunohistochemistry (IHC)|Performed per standard protocols by the Pathology Department.|At baseline|Funding was not available to do correlative studies|||||
752045|NCT00563290|Secondary|Progression-free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Time from start of treatment to time of progression, assessed up to 12 weeks|The second treatment arm of Dasatinib 70 mg orally twice a day was created as a result of an amendment to the protocol therefore the patient PFS data was combined for each arm.||weeks||Full Range|Median
755302|NCT00593606|Primary|Change in Total Bilirubin|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||mg/dl||Standard Deviation|Mean
752046|NCT00563290|Primary|Objective Response Rate (Complete Response and Partial Response)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Every 2 courses during treatment, assessed up to 12 weeks after completion of treatment|||percentage of patients|||Number
752047|NCT00563316|Primary|Number of Participants With Clinically Significant Adverse Events (AEs)|"Adverse events of special interest include infusion reactions, integument toxicities, diarrhea, stomatitis, hypomagnesemia, and pulmonary, vascular, and cardiac toxicities. Infusion reactions were defined as 1. Prespecified signs and symptoms indicating a possible infusion reaction (derived from Common Terminology Criteria for Adverse Events (CTCAE) definitions of allergic reaction/hypersensitivity and cytokine release syndrome/acute infusion reaction) with onset day coincident with any study drug infusion and which resolved the day of, or the day after, onset; 2. incidence of AE with terms consistent with the panitumumab US package insert (USPI) (any event within 24 hours of an infusion during the clinical study described as allergic reaction or anaphylactoid reaction, or any event occurring on the first day of dosing described as allergic reaction, anaphylactoid reaction, fever, chills, or dyspnea).
Data are summarized overall and by treatment phase."|The reporting time frame for Adverse Events is from first dose date to 30 days since the last dose date, until the data cut-off date of 16 July 2009. The median time frame is 5.7 months.|All treated participants||participants|||Number
752048|NCT00563316|Primary|Area Under the Plasma Concentration-time Curve From the Time of the Last Quantifiable Concentration (AUClast) for Irinotecan|To analyze the effect, if any, that panitumumab had on the pharmacokinetics of irinotecan, the AUClast of irinotecan administered alone (Cycle 1) and with concomitant panitumumab (Cycle 2) was measured.|Predose and at 10 minutes, and 0.5, 1, 2, 4, 8, 24, 48, and 72 hours after the end of the irinotecan infusion at cycle 1 (irinotecan alone, week 1 day 1) and cycle 2 (irinotecan with panitumumab, week 3, day 1).|The pharmacokinetic analysis set||hr*ng/mL||Standard Deviation|Mean
752049|NCT00563316|Primary|Area Under the Plasma Concentration-time Curve From the Time of Dosing to Infinity (AUCinf) for Irinotecan|To analyze the effect, if any, that panitumumab had on the pharmacokinetics of irinotecan, the AUCinf of irinotecan administered alone (Cycle 1) and with concomitant panitumumab (Cycle 2) was measured.|Predose and at 10 minutes, and 0.5, 1, 2, 4, 8, 24, 48, and 72 hours after the end of the irinotecan infusion at cycle 1 (irinotecan alone, week 1 day 1) and cycle 2 (irinotecan with panitumumab, week 3, day 1).|The pharmacokinetic analysis set||hr*ng/mL||Standard Deviation|Mean
752050|NCT00563316|Primary|Maximum Observed Plasma Concentration (Cmax) of Irinotecan|To analyze the effect, if any, that panitumumab had on the pharmacokinetics of irinotecan, the Cmax of irinotecan administered alone (Cycle 1) and with concomitant panitumumab (Cycle 2) was measured. Plasma samples were assayed by a validated high performance liquid chromatography (HPLC)-fluorescence method for the measurement of irinotecan. The lower limit of quantitation (LLOQ) was 2 ng/mL.|Predose and at 10 minutes, and 0.5, 1, 2, 4, 8, 24, 48, and 72 hours after the end of the irinotecan infusion at cycle 1 (irinotecan alone, week 1 day 1) and cycle 2 (irinotecan with panitumumab, week 3, day 1).|The pharmacokinetic analysis set included all participants who received panitumumab 6 mg/kg and irinotecan 180 mg/m² without dose reductions or delays and who completed the blood sample collection for pharmacokinetic analysis during cycles 1 and 2.||ng/mL||Standard Deviation|Mean
752051|NCT00563368|Primary|Percentage of Subjects With at Least 5% Weight Loss at Week 28 With LOCF||baseline to 28 weeks|Intent-to-treat Last-observation-carried-forward (ITT-LOCF)||percentage of participants|||Number
752052|NCT00563368|Primary|Percent Weight Loss From Baseline to Week 28|Percent weight loss from baseline to Week 28 with last observation carried forward (LOCF)|baseline to 28 weeks|Intent-to-treat Last-observation-carried-forward (ITT-LOCF)||percent weight loss||Standard Error|Least Squares Mean
752053|NCT00563381|Secondary|Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 16|PEFR means peak expiratory flow rate and is measured in liter per minute|16 weeks|All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples||liter per minute (L/min)||Standard Error|Mean
752054|NCT00563381|Secondary|Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 15|PEFR means peak expiratory flow rate and is measured in liter per minute|16 weeks|All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples||liter per minute (L/min)||Standard Error|Mean
752055|NCT00563381|Secondary|Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 14|PEFR means peak expiratory flow rate and is measured in liter per minute|16 weeks|All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples||liter per minute (L/min)||Standard Error|Mean
752056|NCT00563381|Secondary|Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 13|PEFR means peak expiratory flow rate and is measured in liter per minute|16 weeks|All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples||liter per minute (L/min)||Standard Error|Mean
752057|NCT00563381|Secondary|Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 12|PEFR means peak expiratory flow rate and is measured in liter per minute|16 weeks|All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples||liter per minute (L/min)||Standard Error|Mean
755303|NCT00593606|Primary|Change in Sodium|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||mmol/l||Standard Deviation|Mean
752058|NCT00563381|Secondary|Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 11|PEFR means peak expiratory flow rate and is measured in liter per minute|16 weeks|All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples||liter per minute (L/min)||Standard Error|Mean
752059|NCT00563381|Secondary|Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 10|PEFR means peak expiratory flow rate and is measured in liter per minute|16 weeks|All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples||liter per minute (L/min)||Standard Error|Mean
752060|NCT00563381|Secondary|Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 9|PEFR means peak expiratory flow rate and is measured in liter per minute|16 weeks|All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples||liter per minute (L/min)||Standard Error|Mean
752061|NCT00563381|Secondary|Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 8|PEFR means peak expiratory flow rate and is measured in liter per minute|16 weeks|All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples||liter per minute (L/min)||Standard Error|Mean
752062|NCT00563381|Secondary|Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 7|PEFR means peak expiratory flow rate and is measured in liter per minute|16 weeks|All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples||liter per minute (L/min)||Standard Error|Mean
752063|NCT00563381|Secondary|Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 6|PEFR means peak expiratory flow rate and is measured in liter per minute|16 weeks|All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples||liter per minute (L/min)||Standard Error|Mean
752064|NCT00563381|Secondary|Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 5|PEFR means peak expiratory flow rate and is measured in liter per minute|16 weeks|All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples||liter per minute (L/min)||Standard Error|Mean
752065|NCT00563381|Secondary|Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 4|PEFR means peak expiratory flow rate and is measured in liter per minute|16 weeks|All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples||liter per minute (L/min)||Standard Error|Mean
752066|NCT00563381|Secondary|Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 3|PEFR means peak expiratory flow rate and is measured in liter per minute|16 weeks|All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples||liter per minute (L/min)||Standard Error|Mean
752067|NCT00563381|Secondary|Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 2|PEFR means peak expiratory flow rate and is measured in liter per minute|16 weeks|All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples||liter per minute (L/min)||Standard Error|Mean
752068|NCT00563381|Secondary|Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 1|PEFR means peak expiratory flow rate and is measured in liter per minute|16 weeks|All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples||liter per minute (L/min)||Standard Error|Mean
752069|NCT00563381|Secondary|COPD Exacerbations Treated With Systemic Steroids and Antibiotics Per Patient-year|An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).|52 weeks|All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment||exacerbations per patient-year||95% Confidence Interval|Mean
752070|NCT00563381|Secondary|COPD Exacerbations Treated With Antibiotics Per Patient-year|An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).|52 weeks|All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment||exacerbations per patient-year||95% Confidence Interval|Mean
752071|NCT00563381|Secondary|COPD Exacerbations Treated With Systemic Steroids Per Patient-year|An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).|52 weeks|All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment||exacerbations per patient-year||95% Confidence Interval|Mean
752072|NCT00563381|Secondary|First Occurrence of COPD Exacerbations Treated With Systemic Steroids and Antibiotics|First occurrence analysed by Cox regression as time to first exacerbation treated with systemic steroids and antibiotics and reported as hazard ratio. An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).|52 weeks|All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment||number of first occurrences|||Number
752073|NCT00563381|Secondary|First Occurrence of COPD Exacerbations Treated With Antibiotics|First occurrence analysed by Cox regression as time to first exacerbation treated with antibiotics and reported as hazard ratio. An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).|52 weeks|All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment||number of first occurrences|||Number
752074|NCT00563381|Secondary|First Occurrence of COPD Exacerbations Treated With Systemic Steroids|First occurrence analysed by Cox regression as time to first exacerbation treated with systemic steroids and reported as hazard ratio. An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).|52 weeks|All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment||number of first occurrences|||Number
752075|NCT00563381|Secondary|First Occurrence of COPD Exacerbation or Discontinuation of Trial Medication Because of Worsening of Underlying Disease, Whichever Comes First|First occurrence analysed by Cox regression as time to first exacerbation or discontinuation of trial medication because of worsening of underlying disease, whichever comes first and reported as hazard ratio. An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).|52 weeks|All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment||number of first occurrences|||Number
752076|NCT00563381|Secondary|Number of Participants With Premature Discontinuation of Trial Medication||52 weeks|All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment||Participants|||Number
752077|NCT00563381|Secondary|Occurrence of Premature Discontinuation of Trial Medication|Occurrence analysed by Cox regression as time to premature discontinuation of trial medication and reported as hazard ratio|52 weeks|All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment||number of first occurrences|||Number
752078|NCT00563381|Secondary|Number of Participants With at Least One COPD Exacerbation Leading to Hospitalisation|An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).|52 weeks|All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment||Participants|||Number
752079|NCT00563381|Secondary|First Occurrence of COPD Exacerbation Leading to Hospitalization|First occurrence analysed by Cox regression as time to first exacerbation leading to hospitalisation and reported as hazard ratio. An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).|52 weeks|All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment||number of first occurrences|||Number
752080|NCT00563381|Secondary|COPD Exacerbations Per Patient-year||52 weeks|All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment||exacerbations per patient-year||95% Confidence Interval|Mean
752081|NCT00563381|Secondary|Number of Participants With at Least One COPD Exacerbation|An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).|52 weeks|All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment||Participants|||Number
752082|NCT00563381|Secondary|COPD Exacerbations Per Patient-year Leading to Hospitalisation|An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).|52 weeks|All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment||Hospitalizations per patient-year||95% Confidence Interval|Mean
752125|NCT00556972|Secondary|Assessment of Skin 0-2 Inches From the Edge of the Anus|Skin condition scale: 1 = Normal skin without redness, 2 = Normal redness and intact skin, 3 = Abnormal redness but intact skin, 4 = Red and spotted but intact skin, 5 = Red and broken skin, 6 = Broken and bleeding skin Best skin condition score is 1, and worst skin condition score is 6.|Subjects were evaluated before and after test|ITT||Scores on a scale||Standard Deviation|Mean
752083|NCT00563381|Primary|First Occurrence of (Moderate or Severe) COPD Exacerbation|First occurrence analysed by Cox regression as time to first exacerbation and reported as hazard ratio. An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).|52 weeks|All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment||number of first occurrences|||Number
752084|NCT00563576|Secondary|Percentage of Subjects Who Receive a 3rd Injection||6 months||||||
752085|NCT00563576|Secondary|Number of Subjects Who Receive a 2nd Injection of Depo-Provera||3 months|||participants|||Number
752086|NCT00563576|Secondary|Percentage of Users Who Were Satisfied With Femring|Acceptability was measured using questionnaires that assessed satisfaction of Femring and usage of the ring. This outcome was only measured among the intervention group of women who actually were randomized to use of Femring. Acceptability of the vaginal ring was high among those in the intervention group.|3 months|Acceptability was reported among the 26 participants in the Femring group who were available for followup, i.e., per protocol.||participants|||Number
752087|NCT00563576|Primary|Mean Number of Bleeding or Spotting Days|Bleeding and spotting were defined using World Health Organization criteria and measured through daily diaries given to participants and collected at the 3 and 6 month followup. In addition, a study staff member called participants weekly to collect the daily bleeding and spotting calendar for that week to optimize the accuracy of this information.|3 months|||days||Standard Deviation|Mean
752088|NCT00563706|Secondary|Calgary Depression Scale for Schizophrenia (CDSS) Score|CDSS: 9-item clinician rated scale, validated for rating the severity of depressive symptoms in participants with schizophrenia. Each item is rated on a 4-point scale ranging from 0 (absent) to 3 (severe). CDSS total score is the sum of each item scores and ranges from 0 to 27; higher score indicates more severity of symptoms.|Baseline, Day 7, 14, 21, 28|Because of the failure of all vabicaserin doses to meet the primary efficacy objective, the study was terminated prematurely and planned analyses of secondary efficacy endpoints were not performed.|||||
752089|NCT00563706|Secondary|Clinical Global Impression - Improvement (CGI-I) Score|CGI-I: 7-point clinician rated scale to assess global improvement in the participant’s clinical state compared to baseline; range: 1 (very much improved) to 7 (very much worse).|Day 7, 14, 21, 28|Because of the failure of all vabicaserin doses to meet the primary efficacy objective, the study was terminated prematurely and planned analyses of secondary efficacy endpoints were not performed.|||||
752090|NCT00563706|Secondary|Clinical Global Impression - Severity (CGI-S) Score|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients).|Baseline, Day 7, 14, 21, 28|Because of the failure of all vabicaserin doses to meet the primary efficacy objective, the study was terminated prematurely and planned analyses of secondary efficacy endpoints were not performed.|||||
752091|NCT00563706|Secondary|Percentage of Participants With Response As Per Positive and Negative Symptom Scale (PANSS) Total Score|Responders were defined as 20 percent (%) responders and 50 % responders. A 20% responder was a participant whose PANSS total score was decreased by at least 20% from baseline to the week of assessment. A 50% responder was a participant whose PANSS total score was decreased by at least 50 % from baseline to the week of assessment. PANSS total score assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210; higher score indicates greater severity.|Baseline, Day 7, 14, 21, 28|Because of the failure of all vabicaserin doses to meet the primary efficacy objective, the study was terminated prematurely and planned analyses of secondary efficacy endpoints were not performed.|||||
752092|NCT00563706|Secondary|Positive and Negative Symptom Scale (PANSS) Cognition Cluster Subscale Score|Cognition cluster subscale assesses cognitive symptoms associated with schizophrenia. The cognition cluster subscale score is a sum of 5 items from positive, negative and general psychopathology subscales (conceptual disorganization, difficulty in abstract thinking, poor attention, lack of judgment and insight, and preoccupation). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total cognition cluster subscale scores range from 5 to 35; higher score indicates greater severity.|Baseline, Day 7, 14, 21, 28|Because of the failure of all vabicaserin doses to meet the primary efficacy objective, the study was terminated prematurely and planned analyses of secondary efficacy endpoints were not performed.|||||
752093|NCT00563706|Secondary|Positive and Negative Symptom Scale (PANSS) General Psychopathology Subscale Score|General psychopathology subscale assesses general psychopathology symptoms associated with schizophrenia. The general psychopathology subscale consists of 16 items (somatic concern, anxiety, guilt feelings, tension, mannerisms/posturing, depression, motor retardation, uncooperativeness, unusual thought content, disoriented, poor attention, lack of judgment/insight, disturbance of volition, poor impulse control, preoccupation, and active social avoidance). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total general psychopathology subscale scores range from 16 to 112; higher score indicates greater severity.|Baseline, Day 7, 14, 21, 28|Because of the failure of all vabicaserin doses to meet the primary efficacy objective, the study was terminated prematurely and planned analyses of secondary efficacy endpoints were not performed.|||||
752094|NCT00563706|Secondary|Positive and Negative Symptom Scale (PANSS) Negative Subscale Score|PANSS negative subscale assesses negative symptoms associated with schizophrenia. The negative subscale consists of 7 items (blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total negative subscale scores range from 7 to 49; higher score indicates greater severity.|Baseline, Day 7, 14, 21, 28|Because of the failure of all vabicaserin doses to meet the primary efficacy objective, the study was terminated prematurely and planned analyses of secondary efficacy endpoints were not performed.|||||
752126|NCT00556972|Secondary|Is the Barrier Size and Shape Satisfactory|Percentage of subjects who answered yes to the question: is the barrier size and shape satisfactory|Subjects were followed for the duration of the study, an average of 23 hours|ITT||Percentage of subjects|||Number
752095|NCT00563706|Secondary|Positive and Negative Symptom Scale (PANSS) Positive Subscale Score|PANSS positive subscale assesses positive symptoms associated with schizophrenia. The positive subscale consists of 7 items (delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total positive subscale scores range from 7 to 49; higher score indicates greater severity.|Baseline, Day 7, 14, 21, 28|Because of the failure of all vabicaserin doses to meet the primary efficacy objective, the study was terminated prematurely and planned analyses of secondary efficacy endpoints were not performed.|||||
752096|NCT00563706|Primary|Change From Baseline in Positive and Negative Symptom Scale (PANSS) Total Score at Day 28|PANSS assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210; higher score indicates greater severity.|Baseline, Day 28|mITT population included all randomized participants who received at least 1 dose of double-blind test article, had baseline and at least 1 on-therapy PANSS total score. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Error|Least Squares Mean
752097|NCT00563706|Primary|Positive and Negative Symptom Scale (PANSS) Total Score at Baseline|PANSS assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210; higher score indicates greater severity.|Baseline|Modified intent-to-treat (mITT) population included all randomized participants who received at least 1 dose of double-blind test article, had baseline and at least 1 on-therapy PANSS total score.||units on a scale||Standard Deviation|Mean
752098|NCT00563797|Secondary|Mean Percentage of Heavy Drinking Days by Smoking|The two-way interaction between medication by smoking status to measure percentage of heavy drinking days measured by time line follow back survey. Data were calculated as number of heavy drinking days (heavy drinking days is defined as 5 drinks on a single occasion for men and 4 for women) over the number of days in the study for smokers and non smokers receiving either mecamylamine or placebo.|25 weeks|||percentage of Heavy Drinking Days||Standard Deviation|Mean
752099|NCT00563797|Secondary|Mean Percentage of Number of Drinking Days by Smoking Status|Two-way interaction between smoking and medication for percentage of drinking days captured by time line follow back surveys. Data are calculated as number of drinking days over the number of days in the study for smokers and nonsmokers receiving either mecamylamine or placebo.|25 weeks|||Percentage of Drinking Days||Standard Deviation|Mean
752100|NCT00563797|Primary|Depression - Measured Using the HAMD Total Score|"The Hamilton Depression Rating Scale (HAM-D) has proven useful for many years as a way of determining a patient’s level of depression before, during, and after treatment. It should be administered by a clinician experienced in working with psychiatric patients.
Although the HAM-D form lists 21 items, the scoring is based on the first 17. It generally takes 15-20 minutes to complete the interview and score the results. The Scale ranges from 0 (normal) to >23 (Very Severe Depression)"|12 weeks|||units on a scale||Standard Deviation|Mean
752101|NCT00563797|Primary|Number of Drinking Days|Measured with time line follow back measures|25 weeks|||days||Standard Deviation|Mean
752102|NCT00564265|Primary|Number of Patients Who Survived|The outcomes were measured through follow-up visits of the patients to the out-patient clinic of our institution at 15 days, 1 month, 3 months, 6 months, 1 year, and after that, every year after the surgical treatment.|5 years|This is a consecutive sample of all patients operated on for GISTs in 3 hospitals during a period of 5 years. The period of 5 years was determined by the time that we count with inmunochemistry to confirm GISTs at our institutions, and that time would be the last 5 years. The Last Observation Carried Dorward (LOCF) was made in August 2008.||Participants|||Number
752103|NCT00564278|Secondary|Proportion of Fully Adherent Days|We used the Composite Adherence Score (CAS) described in our grant application to calculate medication adherence levels from all data sources (electronic caps [eCaps], pill count, self-report) and compare these across arms. Calculated via a statistically calibrated algorithm, the CAS relied first on eCaps data, secondarily on pill count, and the adherence questionnaire if eCaps data was missing due to an eCap malfunction. We calculated the number of the days the patient was fully adherent, number of days of partial adherence (e.g., opened the eCap fewer times than prescribed), or number of days of nonadherence when they did not take any prescribed pills. Patients who dropped out of the study and provided no further follow-up data were considered nonadherent for the remainder of the study period. We calculated the therapy-adherent period as a proportion of the total intended treatment period or proportion of days of full adherence, # of fully adherent days / # of days in treatment.|Measured at each visit, up to 36 weeks|All patients in both arms||Proportion of Fully Adherent days||Standard Deviation|Mean
752104|NCT00564278|Secondary|Mean Patient Satisfaction Over 36-week Follow-up Using Client Satisfaction Questionnaire (CSQ)|Patient satisfaction was assessed using the 8-item Client Satisfaction Questionnaire (CSQ) which assesses patients' satisfaction with the services received. CSQ total score ranges from 8-32 with higher scores indicating greater satisfaction. The CSQ was assessed at baseline and the follow-up visits specified below. We calculated the model-estimated mean of the CSQ over 36 weeks using repeated measures.|CSQ at follow-up weeks 2, 4, 8, 12, 20, 28, and 36.|Patients with available data at assessment time points.||units on a scale ranging from 8 to 32||Standard Deviation|Mean
752127|NCT00556972|Primary|The Primary Outcome Measure is Device Wear Time (Time From the Device is Applied Until it is Removed)||5 days|ITT||Hours||Standard Deviation|Mean
752128|NCT00556998|Other Pre-specified|Pharmacokinetic Parameters of Voriconazole in Adolescents Compared to Historical Adult Data - Cmax 300 mg Oral Dose|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Day 7 of oral dosing||||||
752517|NCT00569777|Primary|Lid and Lid Margin Erythema, Change From Baseline|Assessment of lid redness using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.||Units on a scale|Participants|Standard Deviation|Mean
752105|NCT00564278|Primary|Mean Perceived Quality of Life Over 36-week Follow-up Using Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ)|Quality of life was assessed using the 16-item Short Form of the Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ), a self-reported measure of quality of life in 8 domains that is sensitive to depressive symptom severity and treatment response. We analyzed the QLESQ total score as a percentage of the maximum possible score (ranging from 0-100) to facilitate comparisons across areas of functioning. It was calculated as such: % Max = (Raw score - minimum possible score) / (maximum possible score-minimum possible score) where raw score is the sum of the first 14 items. Higher numbers indicate better quality of life, greater enjoyment, and satisfaction. The QLESQ was assessed at baseline and the follow-up visits specified below. We calculated the model-estimated mean of the QLESQ over 36 weeks using repeated measures.|QLESQ at follow-up weeks 2, 4, 8, 12, 20, 28, and 36.|Patients with available data at assessment time points.||percentage of maximum possible score||Standard Deviation|Mean
752106|NCT00564278|Primary|Mean Disability Over 36-week Follow-up Using Sheehan Disability Scale (Impairment)|Psychosocial functioning was assessed using the Sheehan Disability Scale (SDS), a self-report instrument composed of three visual analog subscales assessing degree of disruption caused by symptoms in three domains: work, social/leisure activities, and family/home life. We analyzed the 3 subscale scores for the 3 domains separately which ranged from 0 to 10 with higher scores indicating worse functioning. The SDS was assessed at baseline and the follow-up visits specified below. We calculated the model-estimated mean of the SDS over 36 weeks using repeated measures.|SDS at follow-up weeks 2, 4, 8, 12, 20, 28, and 36.|Patients with available data at assessment time points.||Units on a scale ranging from 0-10||Standard Deviation|Mean
752107|NCT00564278|Primary|Mean of Depressive Symptoms Over 36-week Follow-up Using Hamilton Depression Scale -17-item Version (Symptoms)|"Depressive symptoms were assessed using the 17-item standard clinician-administered version of the Hamilton Depression Scale (HAMD-17). We analyzed the HAMD-17 score, calculated as the sum of the individual items and ranging from 0 to 35 with higher numbers indicating more symptoms. HAMD-17 was assessed at baseline and the follow-up visits specified below.
We calculated the model-estimated mean of the HAMD-17 over 36 weeks using repeated measures."|HAMD-17 assessed at follow-up weeks 2, 4, 8, 12, 20, 28, and 36.|All patients enrolled in both arms with available data at assessment time points.||units on a scale ranging from 0 to 35||Standard Deviation|Mean
752108|NCT00564278|Primary|Number of Days in ADT (Retention)|A continuous measure of the total number of days in treatment, based on visit attendance. At each kept visit, patients will be credited as having been in treatment for the number of days since their last scheduled visit. For example, patients attending sessions on weeks 0, 1, and 12 would have been in treatment for 35 days (7 [week 0 to week 1] + 28 [week 8 to week 12]).|Measured at Months 3 and 9|Patients who signed consent and attended at least one medication visit.||Days in treatment||Standard Deviation|Mean
752109|NCT00556894|Secondary|ACR 20/50/70, ITT and Evaluable Population, Last Observation Carried Disease Activity Score (DAS28) Change From Baseline at Each Visit in the Efficacy Parameters|ACR20/50/70 responses over time (intent-to-treat [ITT], last observation carried forward [LOCF]), mean changes in individual components of the ACR response criteria, DAS28, European League Against Rheumatism (EULAR) responses|12 weeks||||||
752110|NCT00556894|Primary|ACR20|ACR20 response at endpoint at 12 weeks using non-responder imputation.|12 weeks|||participants|||Number
752111|NCT00556933|Secondary|Ratio of CD4/CD8 Lymphoid Cells||One year|||Ratio of cell counts||Standard Deviation|Mean
752112|NCT00556933|Secondary|New-onset Diabetes and Hyperglycemia After Transplantation (NODAT)||Six months|||participants|||Number
752113|NCT00556933|Secondary|New-onset Polyomavirus (BK Virus) Disease Per Kidney Biopsy||Two years|||participants|||Number
752114|NCT00556933|Secondary|Lymphoid Cell Sub-type CD3 Absolute Numbers||One year|||CD3 Cell Numbers/mm^3||Standard Deviation|Mean
752115|NCT00556933|Secondary|Patient Survival||Two years|||participants|||Number
752116|NCT00556933|Secondary|Graft Survival|Graft failure = permanent return of patient to dialysis.|Two years|||participants|||Number
752117|NCT00556933|Secondary|Acute Tubular Necrosis (ATN) Rate, Defined as the Requirement for Dialysis Within 7 Days Post-transplantation.||Seven days|||participants|||Number
752118|NCT00556933|Secondary|Acute Rejection Per Kidney Biopsy (Banff Grading Criteria)||Two years|||participants|||Number
752119|NCT00556933|Secondary|Requirement for Additional Immunosuppression (Such as Corticosteroids, Antimetabolites or Other Immunosuppressive Agents)||Two years|||participants|||Number
752120|NCT00556933|Secondary|Safety Profile|Number of events: cytomegalovirus (CMV) disease, opportunistic infections (bacteremia, abscess, pneumonia, fungal), Post-transplantation Lymphoproliferative Disorder (PTLD), wound healing problems within 30 days, and lymphoceles.|Two years|||Events|Participants||Number
752121|NCT00556933|Primary|Average of Renal Function|Calculated Glomerular Filtration Rate (GFR) by using the abbreviated MDRD (aMDRD) formula and patient serum creatinine and demographic data; averaged values from months four through 24.|Two years|||ml/min/1.73m2||Standard Deviation|Mean
752122|NCT00556933|Primary|Chronic Allograft Nephropathy (Cumulative Calcineurin-inhibitor Nephrotoxicity/Transplant Nephropathy) Per Protocol Surveillance Kidney Biopsies (Banff Grading Criteria).|Protocol kidney biopsies collected at approximately 12 and 24 months were scored by a transplant renal pathologist blinded to treatment group assignment for evidence of rejection, BK virus nephropathy, antibody-mediated rejection, recurrent disease, inflammation, and Banff 2005 categories of chronic renal injury. Chronic injury categories were arteriolar hyaline thickening (ah), allograft glomerulopathy (cg), interstitial fibrosis (ci), tubular atrophy (ct), and vascular fibrous intimal thickening (cv). Severity scores within each category could be 0 (<5%; none or minimal), 1 (>5% - <25%; mild), 2 (>25% - <50%, moderate), or 3 (>50%, severe). The proportions of patients in each severity grade (0, 1, 2, and 3) for both the individual categories and a composite were compared using Fisher’s exact test.|Two years|||percentage of participants|||Number
752123|NCT00556946|Primary|Blanching of Port Wine Stain Birthmark||12 weeks|||participants|||Number
752124|NCT00556972|Secondary|What is Your Assessment of the Ease of Correct Application of the Anal Adhesive?||After application of product|||Pouche and Bag|Participants||Number
752160|NCT00557245|Secondary|Prevalence of Unprotected Sex During Follow-up|Sexual risk behavior of participants, measured as the percentage of visits when participants reported having unprotected sex during follow-up.|Up to 36 months|All randomized participants, less those found to be ineligible (n=11).||percentage of visits|||Number
752129|NCT00556998|Other Pre-specified|Pharmacokinetic Parameters of Voriconazole in Adolescents Compared to Historical Adult Data - Cmax Day 7 Oral All Participants|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Day 7 of oral dosing||||||
752130|NCT00556998|Other Pre-specified|Pharmacokinetic Parameters of Voriconazole in Adolescents Compared to Historical Adult Data - Cmax IV Steady State|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Day 7 of Intravenous dosing||||||
752131|NCT00556998|Other Pre-specified|Pharmacokinetic Parameters of Voriconazole in Adolescents Compared to Historical Adult Data - Cmax IV Loading Dose|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Day 1||||||
752132|NCT00556998|Other Pre-specified|Pharmacokinetic Parameters of Voriconazole in Adolescents Compared to Historical Adult Data - AUC12 Oral 300mg|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Day 7 oral dosing||||||
752133|NCT00556998|Other Pre-specified|Pharmacokinetic Parameters of Voriconazole in Adolescents Compared to Historical Adult Data - AUC12 Oral Dose All Subjects|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Day 7 Oral dosing||||||
752134|NCT00556998|Other Pre-specified|Pharmacokinetic Parameters of Voriconazole in Adolescents Compared to Historical Adult Data - AUC12 IV Steady State|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Day 7 of IV dosing||||||
752135|NCT00556998|Other Pre-specified|Pharmacokinetic Parameters of Voriconazole in Adolescents Compared to Historical Adult Data - AUC12 IV Loading Dose.|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Day 1||||||
752136|NCT00556998|Secondary|Tmax of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration||Day 7 (up to Day 30) at predose, 1, 2, 4, 6, 8, and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.||hours||Full Range|Median
752137|NCT00556998|Secondary|Cmax,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration||Day 7 (up to Day 30) at predose, 1, 2, 4, 6, 8, and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.||μg/mL||Standard Deviation|Geometric Mean
752138|NCT00556998|Secondary|AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration|AUC12,ss = Area under the plasma concentration-time profile from time zero (predose) to twelve hours at steady-state. AUC12,ss was obtained by the Linear/Log trapezoidal method.|On Day 7 (up to Day 30) at predose, 1, 2, 4, 6, 8, and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.||μg*h/mL||Standard Deviation|Geometric Mean
752139|NCT00556998|Secondary|Tmax of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration||Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion and on Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6 8 and 12 hours after start of infusion|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.||μg*h/mL||Full Range|Median
752140|NCT00556998|Secondary|Cmax,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration||Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion and on Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6 8 and 12 hours after start of infusion|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.||μg/mL||Standard Deviation|Geometric Mean
752141|NCT00556998|Secondary|AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration|AUC12,ss = Area under the plasma concentration-time profile from time zero (predose) to twelve hours at steady-state. AUC12,ss was obtained by the Linear/Log trapezoidal method.|Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion and on Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6 8 and 12 hours after start of infusion|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.||μg*h/mL||Standard Deviation|Geometric Mean
752142|NCT00556998|Secondary|Minimum Observed Plasma Trough Concentration (Cmin)||Day 7 (up to Day 20) for IV; Day 7 (up to Day 30) for oral at predose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data; n = number of participants who contributed to data.||μg/mL||Standard Deviation|Geometric Mean
752143|NCT00556998|Secondary|Cmax Following an IV Loading Dose||Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.||μg/mL||Standard Deviation|Geometric Mean
752144|NCT00556998|Secondary|Tmax Following an IV Loading Dose||Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.||hours||Full Range|Median
752145|NCT00556998|Secondary|AUC12 Following IV Loading Dose|AUC12 = Area under the plasma concentration-time profile from time zero (predose) to twelve hours. AUC12 was obtained by the Linear/Log trapezoidal method.|Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.||μg*h/mL||Standard Deviation|Geometric Mean
752146|NCT00556998|Primary|Tmax Following Oral Administration||Day 7 (up to Day 30) Predose, 1, 2, 4, 6, 8, and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.||hours||Full Range|Median
752147|NCT00556998|Primary|Cmax,ss Following Oral Administration||Day 7 (up to Day 30) at predose, 1, 2, 4, 6, 8, and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.||μg/mL||Standard Deviation|Geometric Mean
752148|NCT00556998|Primary|AUC12,ss Following Oral Administration|AUC12,ss = Area under the plasma concentration-time profile from time zero (predose) to twelve hours at steady-state. AUC12,ss was obtained by the Linear/Log trapezoidal method.|Day 7 (up to Day 30) at predose, 1, 2, 4, 6, 8, and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.||μg*h/mL||Standard Deviation|Geometric Mean
752149|NCT00556998|Primary|Time to Reach Cmax (Tmax) Following IV Administration||Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6, 8 and 12 hours after start of infusion|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.||hours||Full Range|Median
752150|NCT00556998|Primary|Peak Plasma Concentration at Steady State (Cmax,ss) Following IV Administration||Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6, 8 and 12 hours after start of infusion|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.||μg/mL||Standard Deviation|Geometric Mean
752151|NCT00556998|Primary|Area Under the Curve Over Dosing Interval at Steady State (AUC12,ss) Following IV Administration|AUC12,ss = Area under the plasma concentration-time profile from time zero (predose) to twelve hours at steady-state. AUC12,ss was obtained by the Linear/Log trapezoidal method.|Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6, 8 and 12 hours after start of infusion|Intent to treat (ITT) population of participants who had completed pharmacokinetic (PK) blood sampling for at least one day. N = number of participants with analyzable data.||μg*h/mL||Standard Deviation|Geometric Mean
752152|NCT00557076|Secondary|Brainstem Auditory Evoked Potentials||End of Experimental Intervention||||||
752153|NCT00557076|Secondary|Functional Magnetic Resonance Imaging (fMRI)||Immediately after treatment ends||||||
752154|NCT00557076|Secondary|Coma Near Coma Scale|The CNC scale measures arousal and awareness and test stimuli are administered to elicit a specified behavior. Presence/absence of this behavior is scored as 0, 2 or 4. Total raw scores range from 0 (consistently responsive) to 36 (extreme coma). The CNC change score was calculated as the 8th CNC measure minus the Baseline CNC measure. Since 2 CNC measurements were collected per week, the 8th CNC measure occurred in Week 4. To calculate the change, we used the eighth CNC measure because two patients (one per group) recovered full consciousness after the eighth CNC measure. In the second statistical analysis, all CNC measures were used to calculate the slope; this includes the Baseline CNC and CNC measures 2-8. Again, we used the first 8 CNC measures (instead of all 12 collected over 6 weeks of treatment) because two patients recovered full consciousness after the eighth CNC measure.|Baseline and after the 8th CNC assessment (4 weeks after Baseline)|||units on a scale||Standard Deviation|Mean
752155|NCT00557076|Primary|DOCS Neurobehavioral Measure (DOCS = Disorders of Consciousness Scale) Change|The primary outcome, the DOCS, is a reliable, valid and precise measure of global neurobehavioral functioning shown to remain stable over six weeks.The DOCS-25 starts with a systematic observation followed by administration of 25 sensory stimuli. Best responses to each stimulus are rated on a scale of 0 to 2 and total raw scores range from 0 (worst) to 50 (best). The DOCS change was calculated as the value at endpoint (6 weeks after Baseline) minus the value at Baseline.|Baseline and immediately after treatment ends (6 weeks after Baseline)|||units on a scale||Standard Deviation|Mean
752156|NCT00557245|Secondary|Head Circumference Among Infants Born to Female Participants Taking Study Drug|The slope of the linear model of the growth of infants (head circumference) during the entirety of follow-up. The head circumference of the infant was measured as a z-score, in terms of standard deviations from the age and gender specific median using the World Health Organization growth curve, accounting for skewness. The slope, representing the change over time of the z-score, was calculated using all available z-scores over 12 months and regressing against study month.|up to 12 months|Infants born to women taking study drug during follow-up||z-score difference per study month|||Number
752157|NCT00557245|Secondary|Weight Among Infants Born to Female Participants Taking Study Drug|The slope of the linear model of the growth of infants (weight) during the entirety of follow-up. The weight of the infant was measured as a z-score, in terms of standard deviations from the age and gender specific median using the World Health Organization growth curve, accounting for skewness. The slope, representing the change over time of the z-score, was calculated using all available z-scores over 12 months and regressing against study month.|up to 12 months|Infants born to women taking study drug during follow-up||z-score difference per study month|||Number
752158|NCT00557245|Secondary|Length Among Infants Born to Female Participants Taking Study Drug|The slope of the linear model of the growth of infants (length) during the entirety of follow-up. The length of the infant was measured as a z-score, in terms of standard deviations from the age and gender specific median using the World Health Organization growth curve, accounting for skewness. The slope, representing the change over time of the z-score, was calculated using all available z-scores over 12 months and regressing against study month.|up to 12 months|Infants born to women taking study drug during follow-up||z-score difference per study month|||Number
752159|NCT00557245|Secondary|Congenital Abnormalities Among Infants Born to Female Participants Taking Study Drug.|Infant outcomes measured as the number of live-born infants born to female participants taking study drug that had any congenital anomalies.|Up to 36 months|Randomized female participants, less those found to be ineligible (n=7)||Number of live-born infants|Participants||Number
752619|NCT00561600|Secondary|Analysis of Metal Ion Release - Erythrocyte Chromium|Erythrocyte chromium|48 months|Metal ion sub-study was limited to two sites. All participants with available data are presented below.||ug/L||Full Range|Median
752161|NCT00557245|Secondary|Number of Participants With a Sexually Transmitted Infection (STI) During Follow-up|"Prevalence of STIs measured as the number of participants with a positive test result for N. gonorrhoeae, C. trachomatis, or T. vaginalis during follow-up. Participants were tested for STIs at annual follow-up visits and at intervening visits at which the participant presented with symptoms of an STI. Assessment for symptomatic sexually transmitted infections was conducted quarterly.
N. gonorrhoeae and C. trachomatis testing were by APTIMA Combo 2 (Gen-Probe) or COBAS Amplicor (Roche Diagnostics). T. vaginalis testing was by APTIMA TV TMA (Gen-Probe) or In Pouch TV (Biomed Diagnostics)."|Up to 36 months|Randomized participants, less those found to be ineligible (n=11)||participants|||Number
752162|NCT00557245|Secondary|Number of Seroconverters With an HIV-1 Mutation Conferring Resistance to TDF or FTC|"HIV-1 resistance as measured by the number of seroconverters who had an HIV-1 reverse transcriptase mutation (K65R, K70E, M184I, or M184V) conferring resistance to TDF or FTC. These mutation types were pre-defined. Plasma samples for resistance testing were collected at the visit seroconversion was first detected and again at a visit within 1 month of seroconversion. Mutations detected at either of those visits are reported.
Both seroconverters found to have a resistance mutation had been HIV infected at enrollment (TDF arm: n=1; FTC-TDF arm: n=1)."|Up to 36 months|Participants who seroconverted during the Partners PrEP trial, including those who were retrospectively found to be HIV infected at enrollment (TDF arm: n=5; FTC-TDF arm: n=3; placebo arm: n=6). For 4 of 96 HIV-1 seroconverters (TDF arm: n=2; FTC-TDF arm: n=1; placebo arm: n=1) HIV-1 RNA was unable to be amplified for HIV-1 resistance testing.||Participants|||Number
752163|NCT00557245|Secondary|Study Drug Adherence: Self-reported Missed Doses of Study Drug|Adherence to study drug measured as the percentage of visits when participants reported missing 1) any dose of study drug in the prior month and 2) 2 or more consecutive doses of study drug.|Up to 36 months|Participants with self-reported adherence.||percentage of visits|||Number
752164|NCT00557245|Secondary|Study Drug Adherence: Total Number of Study Drug Doses Taken of the Total Dispensed Doses.|Adherence to study medication as assessed by pill count at follow-up visits. We assessed the total number of doses taken of the total dispensed doses.|Up to 36 months|||percentage of doses taken of dispensed|||Number
752165|NCT00557245|Primary|Number of Participants With Serious Adverse Events (SAEs)|Safety of daily TDF or FTC/TDF among HIV-1 uninfected individuals randomized to TDF or FTC/TDF compared to those randomized to placebo measured as the number of participants with Serious Adverse Events (SAEs) during follow-up.|Up to 36 months|Randomized participants, less those found to be ineligible (n=11)||Participants|||Number
752166|NCT00557245|Primary|Incidence of HIV-1 Seroconversion Among HIV-1 Uninfected Participants|The efficacy of once daily PrEP in preventing HIV-1 acquisition among uninfected heterosexuals in HIV-1 discordant partnerships, measured by calculating the HIV incidence per 100 person-years in each of three arms.|Up to 36 months|All randomized participants, less those who were found to ineligible (n=11), less those found to be infected at enrollment (n=14), and less those who did not return for any follow-up (n=25).||events per 100 person years||95% Confidence Interval|Number
752167|NCT00557284|Secondary|Mean Change in (Gastrointestinal Symptom Rating Scale) GSRS|The mean change from baseline to study visit 4 (week 1 compared to week 9) in GRGS scores (GI symptoms will be recorded on *GSRS validated scale adjusted for pediatrics (*Gastrointestinal Symptoms in Patients with Irritable Bowel Syndrome and Peptic Ulcer Disease) for all subjects in each arm.This scale measures 7 different GI symptoms (1. abdominal pain; 2. nausea and vomiting; 3. abdominal dissention; 4. decreased passage of stools; 5. increased passage of stools; 6. loose stools; 7. hard stools) with severity ranges from 0 - 3 for each point (0 being no complaint and 3 being most severe for a maximum total of 21).|Baseline and 9 weeks|||units on a scale||Standard Deviation|Mean
752168|NCT00557284|Primary|Mean Change in Weekly Use of Rescue Medication for AD Flare-up - Cetirizine and/or 10% Hydrocortisone Cream|Average of weekly use of cetirizine and/or 10% hydrocortisone cream will be compared for all subjects in each arm from week 1 to week 9. Flare-up is defined as a worsening of the disease that is unacceptable to the participants and leads to second line topical steroid use and/or liquid anti-histamine use. Measurement is noted as 1 for daily use (does not correspond to multiple uses per day).|Baseline and 9 weeks|||days/week||Standard Deviation|Mean
752169|NCT00557284|Primary|Mean Change in Pruritus|Mean change in pruritus scores from baseline to study visit 4 (week 1 compared to week 9) for all subjects in each arm. Pruritus assessments (“itch”) will be recorded for the previous 24 hours using a 4 point-scale, ranging from none (0) to severe (3). Scores are cumulative per week.|Baseline and 9 weeks|||units on a scale||Standard Deviation|Mean
752170|NCT00557284|Primary|Mean Change in PADC (Caregivers Perception of Disease Control)|Mean change in PADC from baseline to study visit 4 (week 1 compared to week 9) for all subjects in each arm. Caregiver’s evaluation of disease control over the previous 7 days and will consist of a four-point scale ranging from complete control (0) to uncontrolled disease (3)|Baseline and 9 weeks|||units on a scale||Standard Deviation|Mean
752171|NCT00557284|Primary|Mean Change in Investigator Global Assessment (IGA)|The mean change in IGA from baseline to study visit 4 (week 1 compared to week 9) for all subjects in each arm. The IGA is a six-point measure of disease severity and is evaluated by the investigator based on the overall assessment of skin lesions: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5= very severe.|Baseline and 9 weeks|||units on a scale||Standard Deviation|Mean
752172|NCT00557284|Primary|Change in Percentage of Body Involvement|Change in percentage of body involvement from baseline to study visit 4 (week 1 compared to week 9) for all subjects in each arm for AD as measured by study investigator|Baseline and 9 weeks|||Change of percentage in body involvement||Standard Deviation|Mean
752173|NCT00557284|Secondary|Mean Change in Serum IgE Levels|Mean change in serum levels of IgE from baseline to study visit 4 (week 1 compared to week 9) for all subjects in each arm.|Baseline and 9 weeks|||kU/L||Standard Deviation|Mean
752174|NCT00557284|Secondary|Mean Change in Serum and Urinary Inflammatory Marker Levels|Mean change in levels from baseline to study visit 4 (week 1 compared to week 9)for interleukin 3 (IL3), tumor necrosis factor alpha (TNF alpha), nerve growth factor (NGF), and urinary leukotriene E4 (LTE4)|Baseline and 9 weeks|||pg/ml||Standard Deviation|Mean
752199|NCT00557362|Secondary|Time to Resolution of Epithelial Defect|Resolution of epithelial defect was defined as the absence of an epithelial defect with administration of fluorescein. The time to re-epithelialization was compared between the voriconazole and natamycin groups using the Cox proportional hazards model, adjusting for baseline epithelial defect size.|3 months from enrollment|||days||Standard Deviation|Mean
752175|NCT00557310|Secondary|Percent Change From Baseline in Serum Carboxyterminal Cross-Linking Telopeptide of Type I Collagen (CTX) at Month 3, 6 and 24 Endpoint|CTX is a measure of bone resorption. Least squares (LS) mean of the percent change from baseline to 3, 6, 24 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline.|Baseline, 3, 6, 24 months|Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.||% change of nanogram/milliliter (ng/mL)||Standard Error|Least Squares Mean
752176|NCT00557310|Secondary|Percent Change From Baseline in Serum Procollagen Type I N-Terminal Propeptide (PINP) at Month 3, 6 and 24 Endpoint|PINP is a measure of bone formation. Least squares (LS) mean of the percent change from baseline to 3, 6, 24 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline.|Baseline, 3, 6, 24 months|Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.||% change of microgram/Liter (µg/L)||Standard Error|Least Squares Mean
752177|NCT00557310|Secondary|Percent Change From Baseline in Areal BMD at Ultra-Distal Radius at Month 18 and 24 Endpoint|Areal BMD is a measure of the amount of mineral in a given area of bone. Least squares (LS) mean of the percent change from baseline to 18 and 24 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use.|Baseline, 18, 24 months|Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.||% change of g/cm²||Standard Error|Least Squares Mean
752178|NCT00557310|Secondary|Percent Change From Baseline in Areal BMD at ⅓ Distal Radius at Month 18 and 24 Endpoint|Areal BMD is a measure of the amount of mineral in a given area of bone. Least squares (LS) mean of the percent change from baseline to 18 and 24 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use.|Baseline, 18, 24 months|Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.||% change of g/cm²||Standard Error|Least Squares Mean
752179|NCT00557310|Secondary|Percent Change From Baseline in Areal BMD Responses at Total Hip at Month 18 and 24 Endpoint|Areal BMD is a measure of the amount of mineral in a given area of bone. Least squares (LS) mean of the percent change from baseline to 18 and 24 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use.|Baseline, 18, 24 months|Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.||% change of g/cm²||Standard Error|Least Squares Mean
752180|NCT00557310|Secondary|Percent Change From Baseline in Areal BMD at the Femoral Neck at Month 18 and 24 Endpoint|Areal BMD is a measure of the amount of mineral in a given area of bone. Least squares (LS) mean of the percent change from baseline to 18 and 24 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use.|Baseline, 18, 24 months|Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.||% change of g/cm²||Standard Error|Least Squares Mean
752181|NCT00557310|Secondary|Percent Change From Baseline in Areal BMD at the Lumbar Spine at Month 18 and 24 Endpoint|Areal BMD is a measure of the amount of mineral in a given area of bone. Least squares (LS) mean of the percent change from baseline to 18 and 24 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use.|Baseline, 18, 24 months|Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.||% change of g/square centimeter (g/cm²)||Standard Error|Least Squares Mean
752182|NCT00557310|Secondary|Percent Change From Baseline in the Estimate of Bone Strength of Hip at Month 18 Endpoint|Finite Element Analysis of computed tomography (CT) data from hip is used to estimate the strength of the proximal femur with a virtual sideways fall. Least squares (LS) mean of the percent change from baseline to 18 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use.|Baseline, 18 months|Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.||% change of Newtons||Standard Error|Least Squares Mean
752183|NCT00557310|Secondary|Percent Change From Baseline in the Estimate of Bone Strength of Lumbar Spine at Month 18 Endpoint|Finite Element Analysis of computed tomography (CT) data from spine is used to estimate the strength of a vertebral body using a virtual axial load. Least squares (LS) mean of the percent change from baseline to 18 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use.|Baseline, 18 months|Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.||% change of Newtons||Standard Error|Least Squares Mean
752184|NCT00557310|Secondary|Percent Change From Baseline in Volumetric Bone Mineral Density (BMD) of Hip at Month 18 Endpoint|Volumetric BMD is a measure of the amount of mineral in a given volume of bone. Least squares (LS) mean of the percent change from baseline to 18 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use.|Baseline, 18 months|Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.||% change of mg/cm³||Standard Error|Least Squares Mean
752185|NCT00557310|Secondary|Percent Change From Baseline in Volumetric Bone Mineral Density (BMD) of Lumbar Spine at Month 18 Endpoint|Volumetric BMD is a measure of the amount of mineral in a given volume of bone, expressed as milligram per cubic centimeter (mg/cm³). Least squares (LS) mean of the percent change from baseline to 18 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use.|Baseline, 18 months|Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.||% change of mg/cm³||Standard Error|Least Squares Mean
752200|NCT00557362|Primary|Best Spectacle Corrected Visual Acuity (BSCVA) 3 Months After Enrollment, Adjusting for Enrollment BSCVA in a Multiple Linear Regression Model|The primary efficacy endpoint was BSCVA at 3 months in the study eye, using a linear regression model with 3-month BSCVA measured in logMAR (logarithm of the Minimum Angle of Resolution) as the outcome variable and treatment arm (voriconazole vs natamycin) and enrollment logMAR BSCVA and corneal de-epithelialization (yes or no) as covariates.|3 months from enrollment|||logMAR||95% Confidence Interval|Mean
752186|NCT00557310|Secondary|Percent Change From Baseline in Surface-to-Curve Ratio (SCR) at Month 3, 6, 12, 18 and 24 Endpoint|SCR is a measure of the computed ratio of plate-like to rod-like structures in a given volume of trabecular bone and reflects the integrity of the trabecular network. The higher the value for SCR, the more intact the trabecular network. Least squares (LS) mean of the percent change from baseline to 3, 6, 12, 18, 24 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline.|Baseline, 3, 6, 12, 18, 24 months|Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.||% change of ratio||Standard Error|Least Squares Mean
752187|NCT00557310|Secondary|Percent Change From Baseline in Bone Volume (BV)/Total Volume (TV) Ratio in the Distal Radius at Month 18 and 24 Endpoint|BV/TV is the estimate of the ratio of detectable bone relative to the total volume of the region of interest. Least squares (LS) mean of the percent change from baseline to 18, 24 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline.|Baseline, 18, 24 months|Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.||% change of ratio||Standard Error|Least Squares Mean
752188|NCT00557310|Secondary|Percent Change From Baseline in Topological Erosion Index (TEI) in the Distal Radius at Month 18 and 24 Endpoint|TEI is the ratio of the sum of topological parameters expected to increase with bone erosion compared to the sum of those expected to decrease. The lower the value for TEI, the more intact the trabecular network. Least squares (LS) mean of the percent change from baseline to 18, 24 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline.|Baseline, 18, 24 months|Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.||% change of ratio||Standard Error|Least Squares Mean
752189|NCT00557310|Secondary|Percent Change From Baseline in Cortical Thickness (CT) in the Distal Radius at Month 18 and 24 Endpoint|Cortical thickness (CT) is the thickness of both cortices in a given volume of bone. Least squares (LS) mean of the percent change from baseline to 18, 24 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline.|Baseline, 18, 24 months|Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.||% change of millimeter (mm)||Standard Error|Least Squares Mean
752190|NCT00557310|Secondary|Percent Change From Baseline in Surface-to-Curve Ratio (SCR) in the Distal Radius at Month 24 Endpoint|SCR is a measure of the computed ratio of plate-like to rod-like structures in a given volume of trabecular bone and reflects the integrity of the trabecular network. The higher the value for SCR, the more intact the trabecular network. Least squares (LS) mean of the percent change from baseline to 24 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline.|Baseline, 24 months|Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.||% change of ratio||Standard Error|Least Squares Mean
752191|NCT00557310|Primary|Percent Change From Baseline in Surface-to-Curve Ratio (SCR) in the Distal Radius at Month 18 Endpoint|SCR is a measure of the computed ratio of plate-like to rod-like structures in a given volume of trabecular bone and reflects the integrity of the trabecular network. The higher the value for SCR, the more intact the trabecular network. Least squares (LS) mean of the percent change from baseline to 18 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline.|Baseline, 18 months|Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.||percent (%) change of ratio||Standard Error|Least Squares Mean
752192|NCT00557323|Secondary|Number of Study-emergent Deaths||5 years|Safety Set||Participants|||Number
752193|NCT00557323|Primary|Number of Study-emergent Bone-related Adverse Events (AEs)||5 years|Safety Set defined as all subjects who received at least one safety measurement during the study.||Bone-related AEs|||Number
752194|NCT00557349|Secondary|Number of Participants With Upper Endoscopy Indicated Due to Complaints|Endoscopic visualization of presence or absence of anastomotic ulcers if upper endoscopy indicated due to patient complaints - based upon severity of complaints|during first 14 weeks after surgery|Patients lost to follow-up were not included in the study analysis.||participants|||Number
752195|NCT00557349|Primary|Number of Participants With Complaints, Specifically About Pain, Vomiting, Dyspepsia, and/or Dysphagia.||during first 14 weeks after surgery|Patients lost to follow-up were not included in the data analysis.||participants|||Number
752196|NCT00557362|Secondary|Best Hard Contact Lens-corrected Visual Acuity 3 Months After Enrollment in a Multiple Linear Regression Model With Enrollment Hard Contact Lens-corrected Visual Acuity as a Covariate|Best hard contact lens-corrected visual acuity 3 months after enrollment was evaluated in a multiple linear regression model with enrollment hard contact lens-corrected visual acuity as a covariate. Visual acuity is reported in logMAR (logarithm of the Minimum Angle of Resolution).|3 months from enrollment|||logMAR||95% Confidence Interval|Mean
752197|NCT00557362|Secondary|Subgroup Analysis - Best Spectacle-corrected Visual Acuity Examined by Voriconazole and Natamycin Treatment Arms in Subgroups of Fungal Ulcers (Fusarium Spp and Aspergillus Spp).|Two subgroup analyses were conducted by causative organism: 1) best spectacle-corrected visual acuity (BSCVA) by treatment arm among Fusarium ulcers; 2) best spectacle-corrected visual acuity (BSCVA) by treatment arm among Aspergillus ulcers.|3 months from enrollment|This analysis looks at two different subgroups - Fusarium ulcers and Aspergillus ulcers. There were 44 Fusaruim ulcers enrolled in this trial and analyzed here, 23 of which were randomized to voriconazole and 21 to natamycin. There were 19 Aspergillus ulcers analyzed here, 8 of which were randomized to voriconazole and 11 to natamycin.||logMAR||95% Confidence Interval|Mean
752198|NCT00557362|Secondary|Size of Infiltrate/Scar Post-treatment Was Analyzed in a Linear Regression Model Using Enrollment Infiltrate/Scar Size as a Covariate.|Size of infiltrate/scar post-treatment was analyzed in a linear regression model using enrollment infiltrate/scar size as a covariate. No differentiation was made between infiltrate and scar when measuring infiltrate/scar size (measured in mm). For analysis, infiltrate/scar size was characterized by the geometric mean of the longest dimension and the longest perpendicular.|3 months from enrollment|||mm||95% Confidence Interval|Mean
752201|NCT00557440|Secondary|Forced Vital Capacity (FVC) at Single Time Points|"Vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.
FVC was analyzed using ANCOVA adjusting for treatment, period, sequence and center with period baseline as a covariate and patient nested within sequence as a random effect."|5, 30 minutes, 1, 2, 3, 4 hours, 11 hours 10 minutes, 11 hours 45 minutes, 12 hours 30 minutes, 14, 16, 18, 20, 22 hours, 23 hours 10 minutes, and 23 hours 45 minutes post-dosing.|Intent-to-treat population, where data were available. Patients who took rescue medication within 6 hours prior to spirometry measurements were excluded from the analysis. N indicates the number of participants with available data at each time point.||liters||Standard Error|Least Squares Mean
752202|NCT00557440|Secondary|Time to Peak Forced Expiratory Volume in 1 Second (FEV1)|"FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Time to peak FEV1 is calculated in minutes from the time of inhalation of study drug to the time of the peak FEV1 during the first 4 hours post-dose.
Time to peak FEV1 is based on log-transformed analysis of variance adjusted for treatment, period, sequence and center, with patient nested within sequence as a random effect. Geometric Mean was obtained by taking anti-logs of the adjusted means from the model and standard error was calculated using the delta method."|Up to 4 hours post-dose|Intent-to-treat population, where data were available. Patients who took rescue medication within 6 hours prior to spirometry measurements were excluded from the analysis.||minutes||Standard Error|Geometric Mean
752203|NCT00557440|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Standardized Area Under the Curve (AUC) Between Baseline (Pre-dose) and 24 Hours Post-dose|"FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEV1 was measured pre-dose and up to 24 hours post-dose. The FEV1 standardized area under the curve (AUC) was analyzed for four time intervals:
Baseline (pre-dose) to 4 hours (hr) post-dosing;
Baseline (pre-dose) to 23 hours, 45 minutes (min) post-dosing;
11 hours, 10 minutes to 12 hours, 30 minutes post-dosing;
11 hours, 10 minutes to 23 hours, 45 minutes post-dosing.
AUC for FEV1 was analyzed using Analysis of Covariance adjusting for treatment, period, sequence and center with period baseline as a covariate and patient nested within sequence as a random effect."|Pre-dose, 5, 30 minutes, 1, 2, 3, 4 hours, 11 hours 10 minutes, 11 hours 45 minutes, 12 hours 30 minutes, 14, 16, 18, 20, 22 hours, 23 hours 10 minutes, and 23 hours 45 minutes post-dosing.|Intent-to-treat population, where data were available. Patients who took rescue medication within 6 hours prior to spirometry measurements were excluded from the analysis. N indicates the number of participants with available data at each time point.||liters||Standard Error|Least Squares Mean
752204|NCT00557440|Secondary|Forced Expiratory Volume in 1 Second (FEV1) at Single Time Points|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEV1 was analyzed using Analysis of Covariance (ANCOVA) adjusting for treatment, period, sequence and center with period baseline as a covariate and patient nested within sequence as a random effect.|5, 30 minutes, 1, 2, 3, 4 hours, 11 hours 10 minutes, 11 hours 45 minutes, 12 hours 30 minutes, 14, 16, 18, 20, 22 hours, 23 hours 10 minutes, and 23 hours 45 minutes post-dosing.|Intent-to-treat population, where data were available. Patients who took rescue medication within 6 hours prior to spirometry measurements were excluded from the analysis. N indicates the number of participants with available data at each time point.||liters||Standard Error|Least Squares Mean
752205|NCT00557440|Primary|Change From Period Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1)|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change from the period baseline to 24 hour post dose trough FEV1 after 1 day of treatment was analyzed using Analysis of Covariance (ANCOVA) adjusting for treatment, period, sequence and center with period baseline as a covariate and patient nested within sequence as a random effect.|Pre-dose for each Treatment Period (Days 1, 8 and 15) and 24-hours post-dose for each Treatment Period (Days 2, 9 and 16).|The Intent-To-Treat (ITT) population included all randomized patients who had at least one period containing a Baseline FEV1 measurement and at least one post-baseline measurement of FEV1 for the same treatment period. Patients who took rescue medication within 6 hours prior to the trough measurements were excluded from the analysis.||liters||Standard Error|Least Squares Mean
752206|NCT00557466|Secondary|Number of Participants Using Rescue Medication|Participants recorded the use of rescue medications (salbutamol/albuterol) for treatment of asthma symptoms twice a day in a diary during the 14 days of the treatment period.|Over 14 days|Intent to treat||participants|||Number
752207|NCT00557466|Secondary|Change From Baseline in Morning and Evening Peak Expiratory Flow|The Peak Expiratory Flow (PEF) rate is the maximal rate that a person can exhale during a short maximal expiratory effort after fully inhaling. Participants measured their PEF using a peak flow meter prior to taking study medication and recorded measurements in a diary every morning and evening during the study. Change from baseline is the difference between the mean baseline PEF recorded during the screening period until the first day of treatment, and the overall mean PEF from Days 1 to 14.|Baseline (recorded during the screening period) and Days 1-14 (treatment period).|Intent to treat population. The analysis only includes patients with non-missing data.||liters/minute||Standard Deviation|Mean
752208|NCT00557466|Secondary|Time to Peak Forced Expiratory Volume in 1 Second (FEV1) on Day 1 and Day 14|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Time to peak FEV1 is calculated in minutes from the time of inhalation of study drug to the time of the peak FEV1, which is taken as the maximum FEV1 recorded post-dose.|Day 1 and Day 14 measured pre-dose and up to 4 hours post-dose|"The intent-to-treat population (ITT) population consisted of all randomized patients who had a baseline and at least one post-dose FEV1 measurement. The analysis only includes patients with non-missing data, indicated by N."||minutes||Standard Deviation|Mean
752209|NCT00557466|Secondary|Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Between Baseline (Predose) and 4 Hours Post-dose on Day 1|FEV1 was measured on Day 1 pre-dose and up to 4 hours post-dose. The Area Under the Curve (AUC) for FEV1 was analyzed using Analysis of Covariance adjusting for treatment and region with baseline FEV1 as a covariate.|Day 1; pre-dose and at 5, 20, 30 minutes and 1, 2, 3, and 4 hours post-dose.|The intent-to-treat population (ITT) population consisted of all randomized patients who had a baseline and at least one post-dose FEV1 measurement. Observed data only.||liters||Standard Error|Least Squares Mean
752620|NCT00561600|Secondary|Analysis of Metal Ion Release - Erythrocyte Cobalt|Erythrocyte Cobalt|48 months|Metal ion sub-study was limited to two sites. All participants with available data are presented below.||ug/L||Full Range|Median
752210|NCT00557466|Secondary|The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1) on Day 1|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change from baseline to 24 hour post dose trough FEV1 after 1 day of treatment was analyzed using Analysis of Covariance (ANCOVA) adjusting for treatment and region with baseline FEV1 as a covariate.|Day 1 Baseline (prior to first dose) and 24 hours post-dose.|The intent-to-treat population (ITT) population consisted of all randomized patients who had a baseline and at least one post-dose FEV1 measurement. The analysis only includes patients with non-missing data.||liters||Standard Error|Least Squares Mean
752211|NCT00557466|Secondary|Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Between Baseline (Predose) and 4 Hours Post-dose|FEV1 was measured on Day 14 pre-dose and up to 4 hours post-dose. The Area Under the Curve (AUC) for FEV1 was analyzed using Analysis of Covariance adjusting for treatment and region with baseline FEV1 as a covariate.|Day 14, pre-dose and at 5, 20, 30 minutes and 1, 2, 3, and 4 hours post-dose.|The intent-to-treat population (ITT) population consisted of all randomized patients who had a baseline and at least one post-dose FEV1 measurement. Observed data only.||liters||Standard Error|Least Squares Mean
752212|NCT00557466|Primary|The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1)|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change from baseline to 24 hour post dose trough FEV1 after 14 days of treatment was analyzed using Analysis of Covariance (ANCOVA) adjusting for treatment and region with baseline FEV1 as a covariate.|Baseline (prior to first dose) and Day 15 (24 hours after last dose)|The intent-to-treat population (ITT) population consisted of all randomized patients who had a baseline and at least one post-dose FEV1 measurement. The analysis only includes patients with non-missing data.||liters||Standard Error|Least Squares Mean
752213|NCT00557492|Secondary|Ca 19-9 Level (in Serum) - Biomarker Response|Percentage decrease in Ca 19-9 level (in serum)|Baseline and up to 48 months|Participants that did NOT demonstrate metastatic progression upon restaging CT.||percentage decrease in serum Ca19-9 leve||Standard Deviation|Mean
752214|NCT00557492|Secondary|Radiographic Tumor Response|CT scans evaluated for response using Response Evaluation Criteria in Solid Tumors (RECIST)|Up to 48 months|||Participants|||Number
752215|NCT00557492|Secondary|Rate of Surgical Resection|Number of participants that underwent resection / per the total number of evaluable participants|Up to 48 months|||percentage of participants|||Number
752216|NCT00557492|Secondary|Progression-free Survival (PFS)||Up to 48 months|Includes participants who underwent laparoscopy and pancreatic resection.||months||95% Confidence Interval|Median
752217|NCT00557492|Secondary|Progression-free Survival (PFS)||Up to 48 months|Includes entire study cohort.||months||95% Confidence Interval|Median
752218|NCT00557492|Secondary|Overall Survival (OS)||Up to 48 months|Includes participants who underwent laparoscopy and pancreatic resection.||months||95% Confidence Interval|Number
752219|NCT00557492|Secondary|Overall Survival (OS)||Up to 48 months|Includes entire study cohort.||months||95% Confidence Interval|Number
752220|NCT00557492|Primary|Rate of Pathologic Complete Response (pCR)|Rate of pathologic complete response (pCR) is no residual invasive tumor, in situ carcinoma can be present, and no residual lymph node metastasis. Rate of pCR is the number of participants who underwent laparoscopy and pancreatic resections that experienced complete pathologic response/total number of participants who underwent laparoscopy and pancreatic resections.|Up to 48 months|Participants who underwent laparoscopy and pancreatic resections.||percentage of participants||95% Confidence Interval|Number
752221|NCT00557492|Primary|Rate of Margin Negative Surgical Resection (R0 Resection Rate)|Number of participants who underwent laparoscopy and pancreatic resections that were margin negative/total number of participants who underwent laparoscopy and pancreatic resections.|Up to 48 months|Participants who underwent laparoscopy and pancreatic resection.||percentage of participants||95% Confidence Interval|Number
752222|NCT00557505|Other Pre-specified|Change From Baseline in Tumor Proteins Related to P-cadherin Signaling and/or Tumor Proliferation or Apoptosis by Immunohistochemistry (IHC)||Baseline and cycle 3|Data was not analyzed, as development of the compound was terminated.||pg/mL||Standard Deviation|Mean
752223|NCT00557505|Other Pre-specified|Change From Baseline in Cytokine Concentration||Pre-dose (baseline), 1, 6 and 24 hrs after start of infusion on Day 1 cycle 1|Data was not analyzed, as development of the compound was terminated.||picogram (pg)/mL||Standard Deviation|Mean
752224|NCT00557505|Other Pre-specified|Change From Baseline in Leucocyte Subtypes||Baseline, Day 1 cycle 1, Day 1 Cycle 2, Day 1 of every other cycle starting from cycle 3 up to EOT or withdrawal|Data was not analyzed, as development of the compound was terminated.||cells/mL|||Number
752225|NCT00557505|Other Pre-specified|Change From Baseline in Circulating Tumor Cells (CTC) Concentration in Blood||Pre-dose (baseline), Day 8 cycle 1, Day 1 Cycle 2 and Day 1 of every other cycle starting from cycle 3 up to EOT or withdrawal|Data was not analyzed, as development of the compound was terminated.||cells/mL|||Number
752226|NCT00557505|Other Pre-specified|Time to Disease Progression|Time in weeks from start of study treatment to first documentation of objective disease progression or death due to disease, whichever comes first.|Baseline to disease progression or 4 weeks after the first dose and then every 6 weeks up to Week 37|Data was not analyzed, as antitumor activity was not observed.||weeks||Full Range|Median
752227|NCT00557505|Other Pre-specified|Change From Baseline in Standardized Uptake Values (SUV) of 18F-fluoro-3'-Deoxy-3'-L-fluorothymidine Positron Emission Tomography (FLT-PET)||Baseline, cycle 3 and after 8 weeks|Data was not analyzed, as development of the compound was terminated.||standardized uptake value (SUV)||Standard Deviation|Mean
752228|NCT00557505|Other Pre-specified|Human Anti-Human Antibody (HAHA) Levels|HAHA are indicators of immunogenicity to PF-03732010.|Pre-dose on Day 1 of Cycle 2 and Day 1 of every other cycle up to Week 4, 8 and 12 after the last dose or withdrawal|Data was not analyzed, as development of the compound was terminated.||microgram/mL||Standard Deviation|Mean
752259|NCT00557856|Other Pre-specified|Human Anti - Human Antibody (HAHA) Concentration: Part 1 and Part 2|HAHA concentration was analyzed in blood samples for the evaluation of immunogenicity of PF-03446962. HAHA concentration was reported for samples above lower limit of quantification (>=4.32).|Baseline up to 3 months after last dose|Statistical Data was not statistically summarized as majority of participants had concentration below the limit of quantification.|||||
752229|NCT00557505|Secondary|Number of Participants With Objective Response of Complete Response or Partial Response|Number of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. PR are those with at least 30 percent decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Baseline to disease progression or 4 weeks after the first dose and then every 6 weeks up to Week 37|Data was not analyzed, as antitumor activity was not observed.||participants|||Number
752230|NCT00557505|Secondary|Apparent Volume of Distribution (Vd)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.|0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal|Data was not summarized, as development of the compound was terminated.||Liter||Standard Deviation|Geometric Mean
752231|NCT00557505|Secondary|Clearance (CL)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal|Data was not summarized, as development of the compound was terminated.||Liter/hr||Standard Deviation|Geometric Mean
752232|NCT00557505|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).|0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal|Data was not summarized, as development of the compound was terminated.||ng*hr/mL||Standard Deviation|Geometric Mean
752233|NCT00557505|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-14 Day)]|AUC (0-14)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-14 day).|0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal|Data was not summarized, as development of the compound was terminated.||ng*hr/mL||Standard Deviation|Geometric Mean
752234|NCT00557505|Secondary|Maximum Observed Serum Concentration (Cmax)||0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal|Data was not summarized, as development of the compound was terminated.||ng/mL||Standard Deviation|Geometric Mean
752235|NCT00557505|Secondary|Minimum Observed Serum Trough Concentration (Cmin)||0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal|Data was not summarized, as development of the compound was terminated.||ng/mL||Standard Deviation|Geometric Mean
752236|NCT00557505|Secondary|Time to Reach Maximum Observed Serum Concentration (Tmax)||0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal|Data was not summarized, as development of the compound was terminated.||hr||Full Range|Median
752237|NCT00557505|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-28 Day)]|AUC (0-28 day)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-28 day).|0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal|Data was not summarized, as development of the compound was terminated.||nanogram*hour/milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
752238|NCT00557505|Primary|Recommended Phase-2 Dose (RP2D)||Baseline up to EOT or withdrawal assessed up to Day 7 of last cycle|Data was not analyzed, as development of the compound was terminated.||mg/kg|||Number
752239|NCT00557505|Primary|Maximum Tolerated Dose (MTD)||Baseline up to end of treatment (EOT) or withdrawal assessed up to Day 7 of last cycle|MTD analysis population included all participants enrolled in the dose escalation part of the study who received at least 1 dose of study medication.||mg/kg|||Number
752240|NCT00557622|Secondary|Number of Participants With a Clinical Global Impression (CGI) Global Improvement of 4 at Week 12|The participant's status was assessed using the following 8-point scale: 0, Not assessed; 1,Very much improved; 2, Much Improved; 3, Minimally improved; 4, No change; 5, Minimally worse; 6, Much worse; 7, Very much worse.|Week 12|Full Analysis Set (FAS): All participants who received at least one dose of study medication for the treatment phase and had at least one post-baseline efficacy assessment. Participants who failed to satisfy major entry criteria measured prior to randomization (e.g., participant with disease other than PTSD) were excluded.||participants|||Number
752241|NCT00557622|Secondary|Number of Participants With the Indicated Change From Baseline in CGI (Clinical Global Impression) Severity of Illness Scores at Weeks 2, 4, 6, 8, 10, and 12|The participant's status was assessed using the following 8-point scale: 0, Not assessed; 1, Normal, not at all ill; 2, Borderline mentally ill; 3, Mildly ill; 4, Moderately ill; 5, Markedly ill; 6, Severely ill; 7, Among the most extremely ill patients.|Baseline and Weeks 2, 4, 6, 8, 10, and 12|Full Analysis Set (FAS): All participants who received at least one dose of study medication for the treatment phase and had at least one post-baseline efficacy assessment. Participants who failed to satisfy major entry criteria measured prior to randomization (e.g., participant with disease other than PTSD) were excluded.||participants|||Number
752621|NCT00561600|Secondary|Analysis of Metal Ion Release - Serum Chromium|Serum Chromium|48 months|Metal ion sub-study was limited to two sites. All participants with available data are presented below.||ug/L||Full Range|Median
752242|NCT00557622|Secondary|Number of Participants With the Indicated Change From Baseline in CAPS-SX (Clinician-Administered Post Traumatic Stress Disorder [PTSD] Scale One Week Symptom Status Version) Relating Increased Arousal Symptom at Weeks 4, 8, and 12|The Clinical-Administered PTSD Scale (CAPS) is a structured interview for assessing PTSD diagnostic status and symptom severity. The CAPS assesses both the frequency and intensity of individual PTSD symptoms on separate five-point (0-4) rating scales, and these ratings can be summed to create a nine-point (0-8) severity score for each symptom. The total CAPS score can range from 0 to 136, with a higher value indicating increased severity. A minus value for change from baseline indicates an improvement of symptom severity.|Baseline and Weeks 4, 8, and 12|Full Analysis Set (FAS): All participants who received at least one dose of study medication for the treatment phase and had at least one post-baseline efficacy assessment. Participants who failed to satisfy major entry criteria measured prior to randomization (e.g., participant with disease other than PTSD) were excluded.||participants|||Number
752243|NCT00557622|Secondary|Number of Participants With the Indicated Change From Baseline in CAPS-SX (Clinician-Administered Post Traumatic Stress Disorder [PTSD] Scale One Week Symptom Status Version) Relating Avoidance and Numbing at Weeks 4, 8, and 12|The Clinical-Administered PTSD Scale (CAPS) is a structured interview for assessing PTSD diagnostic status and symptom severity. The CAPS assesses both the frequency and intensity of individual PTSD symptoms on separate five-point (0-4) rating scales, and these ratings can be summed to create a nine-point (0-8) severity score for each symptom. The total CAPS score can range from 0 to 136, with a higher value indicating increased severity. A minus value for change from baseline indicates an improvement of symptom severity.|Baseline and Weeks 4, 8, and 12|Full Analysis Set (FAS): All participants who received at least one dose of study medication for the treatment phase and had at least one post-baseline efficacy assessment. Participants who failed to satisfy major entry criteria measured prior to randomization (e.g., participant with disease other than PTSD) were excluded.||participants|||Number
752244|NCT00557622|Secondary|Number of Participants With the Indicated Change From Baseline in CAPS-SX (Clinician-Administered Post Traumatic Stress Disorder [PTSD] Scale One Week Symptom Status Version) Relating Re-experiencing at Weeks 4, 8, and 12|The Clinical-Administered PTSD Scale (CAPS) is a structured interview for assessing PTSD diagnostic status and symptom severity. The CAPS assesses both the frequency and intensity of individual PTSD symptoms on separate five-point (0-4) rating scales, and these ratings can be summed to create a nine-point (0-8) severity score for each symptom. The total CAPS score can range from 0 to 136, with a higher value indicating increased severity. A minus value for change from baseline indicates an improvement of symptom severity.|Baseline and Weeks 4, 8, and 12|Full Analysis Set (FAS): All participants who received at least one dose of study medication for the treatment phase and had at least one post-baseline efficacy assessment. Participants who failed to satisfy major entry criteria measured prior to randomization (e.g., participant with disease other than PTSD) were excluded.||participants|||Number
752245|NCT00557622|Secondary|Number of Participants With the Indicated Change From Baseline in CAPS-SX (Clinician-Administered Post Traumatic Stress Disorder [PTSD] Scale One Week Symptom Status Version) Total Score at Weeks 4 and 8|The Clinical-Administered PTSD Scale (CAPS) is a structured interview for assessing PTSD diagnostic status and symptom severity. The CAPS assesses both the frequency and intensity of individual PTSD symptoms on separate five-point (0-4) rating scales, and these ratings can be summed to create a nine-point (0-8) severity score for each symptom. The total CAPS score can range from 0 to 136, with a higher value indicating increased severity. A minus value for change from baseline indicates an improvement of symptom severity.|Baseline and Weeks 4 and 8|Full Analysis Set (FAS): All participants who received at least one dose of study medication for the treatment phase and had at least one post-baseline efficacy assessment. Participants who failed to satisfy major entry criteria measured prior to randomization (e.g., participant with disease other than PTSD) were excluded.||participants|||Number
752246|NCT00557622|Secondary|Number of Participants With the Indicated Week 0 and Week 12 Z-scores for Regional Blood Flow Using Functional Magnetic Resonance Imaging (fMRI) in the Left Amygdala (LA), Right Amygdala (RA), and the Medial Prefrontal Cortex (MPFC)|Change in regional blood flow (rCBF) measured by fMRI represents altered neuronal responses in PTSD patients and is considered to be the biomarker for treatment response. fMRI measures are provided as blood oxygeneration level-dependent (BOLD) signals (z-score). To trigger neuronal activation, 2 visual stimuli were used: MVA-task (consisting of MVA-related and unpleasant pictures) and face-task (consisting of a variety of facial expressions [e.g., neutral, happy, fear]). Week 0 and 12 rCBF data from 1 participant were invalid (involuntary movement in the fMRI machine); no analysis was done.|Baseline and Week 12|Full Analysis Set (FAS): All participants who received at least one dose of study medication for the treatment phase and had at least one post-baseline efficacy assessment. Participants who failed to satisfy major entry criteria measured prior to randomization (e.g., participant with disease other than PTSD) were excluded.||participants|||Number
752247|NCT00557622|Primary|Number of Participants With the Indicated Change From Baseline in CAPS-SX (Clinician-Administered Post Traumatic Stress Disorder (PTSD) Scale One Week Symptom Status Version) Total Score at Week 12|The Clinical-Administered PTSD Scale (CAPS) is a structured interview for assessing PTSD diagnostic status and symptom severity. The CAPS assesses both the frequency and intensity of individual PTSD symptoms on separate five-point (0-4) rating scales, and these ratings can be summed to create a nine-point (0-8) severity score for each symptom. The total CAPS score can range from 0 to 136, with a higher value indicating increased severity. A minus value for change from baseline indicates an improvement of symptom severity.|Baseline and Week 12|Full Analysis Set (FAS): All participants who received at least one dose of study medication for the treatment phase and had at least one post-baseline efficacy assessment. Participants who failed to satisfy major entry criteria measured prior to randomization (e.g., participant with disease other than PTSD) were excluded.||participants|||Number
752248|NCT00557830|Post-Hoc|Median Progression Free Survival (PFS)|PFS is defined as the duration of time from start of treatment to time of progression or death, whichever comes first. Progression is defined per RECIST criteria as at least a 20% increase in the sum of the longest dimension (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or the appearance of one or more new non-target lesions and/or unequivocal progression of existing non-target lesions. The median progression free survival is the parameter used to describe PFS.|PFS was measured from day 1 of treatment until time of progression (assessed every 8 weeks) or death, whichever occurred first|||Months||95% Confidence Interval|Median
752249|NCT00557830|Secondary|Changes From Baseline in Symptom Burden|"The Patient Care Monitor Version 2.0 (PCM) is an tablet computer based assessment system that measures patient reported outcomes (PROs) in medical patients with a particular emphasis on symptoms related to cancer and its treatment.
The PCM comprises 86 items which include 8 items answered only by females (e.g. menstrual cramping). Each item is presented so that the patient rates the degree to which the item has been a problem in the past week (0 not a problem to 10 as bad as possible)."|The PCM was administered during screening, at each scheduled visit (approximately every 4 weeks), and at the end of treatment visit.|||units on a scale||Standard Deviation|Mean
752250|NCT00557830|Secondary|Overall Survival Rate|Due to the early study closure and the small sample size, overall survival rate was not evaluated.|Overall survival was measured from day 1 of treatment until the end of treatment and then every 4 months thereafter until death.|Due to the early study closure and the small sample size, overall survival rate was not evaluated.|||||
752251|NCT00557830|Secondary|PFS Rate at 9, 13 and 17 Months|Due to the early study closure and the small sample size, the PFS rate at 9, 13, and 17 months were not evaluated.|PFS was to be measured at 9, 13, and 17 months.|Due to the early study closure and the small sample size, the PFS rate at 9, 13, and 17 months were not evaluated.|||||
752252|NCT00557830|Primary|Overall Response Rate (CR + PR) Determined by the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria.|Response was evaluated via changes from baseline in radiological tumor measurements performed every 8 weeks and at the end of treatment unless clinically indicated prior to that. Confirmatory scans were to be obtained no less than 4 weeks but no more than 6 weeks following initial documentation of objective response. Response was evaluated using RECIST criteria, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is >=30% decrease in the sum of the longest diameter (LD) of target lesions; stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease; Progressive disease (PD) is at least a 20% increase in the sum of LD of target lesions or the appearance of one or more new lesions.|Overall response will be measured at baseline and every 8 weeks , unless clinically indicated prior to that, until the end of treatment.|||Participants|||Number
752253|NCT00557856|Other Pre-specified|Circulating Endothelial Cells (CEC)and Circulating Endothelial Progenitors (CEP): Part 1 and Part 2|Circulating endothelial cells (CECs) are noninvasive marker of vascular damage, remodeling, and dysfunction. Blood samples for the assessment of CECs and circulating CEPs were collected to analyze effects of therapy on the number, viability/apoptotic state, and/or target activity/expression in CECs. Circulating Cells were classified as CEPs if cluster differentiation 133 positive cells (CD133+) were detected.|Baseline (pre-dose of C1D1), C1D1 6 hours post dosing, C1D22, C2D1, C3D1 and end of treatment (Day 490)|Data was reported in individual participant listings but not statistically summarized due to statistical constraints.|||||
752254|NCT00557856|Other Pre-specified|Soluble Protein Biomarker [Vascular Endothelial Growth Factor Receptor Type 2 (VEGFR2), Vascular Endothelial Growth Factor Receptor Type 3 (VEGFR3)]: Part 1 and Part 2|Plasma concentrations of soluble proteins (VEGFR2, VEGFR3) may be associated with tumor angiogenesis or tumor physiology and may correlate with efficacy or biological activity.|Baseline (pre-dose of C1D1), C1D1 6 hours post dosing, C1D22, C2D1, C3D1 and end of treatment (Day 490)|Soluble Protein Biomarker Analysis Set included all participants who received at least one dose of study drug with a baseline (pre-dose C1D1) or screening biomarker result, and at least one on-treatment biomarker result for at least one biomarker. “n” signifies those participants who were evaluable at specific time-point.||pg/ml||Standard Deviation|Mean
752255|NCT00557856|Other Pre-specified|Soluble Protein Biomarker [Vascular Endothelial Growth Factor C (VEGF-C), Vascular Endothelial Growth Factor-d (VEGF-d), Vascular Endothelial Growth Factor Receptor Type 1 (VEGFR1)]: Part 1 and Part 2|Plasma concentrations of soluble proteins (VEGF-C, VEGF-d, VEGFR1) may be associated with tumor angiogenesis or tumor physiology and may correlate with efficacy or biological activity.|Baseline (pre-dose of C1D1), C1D1 6 hours post dosing, C1D22, C2D1, C3D1 and end of treatment (Day 490)|Soluble protein biomarker analysis set included all participants who received at least one dose of study drug with a baseline (pre-dose C1D1) or screening biomarker result, and at least one on-treatment biomarker result for at least one biomarker. “n” signifies those participants who were evaluable at specific time-point.||pg/ml||Standard Deviation|Mean
752256|NCT00557856|Other Pre-specified|Soluble Protein Biomarker [Placental Growth Factor (PLGF), Transforming Growth Beta 1 (TGFB1), Vascular Endothelial Growth Factor A (VEGF-A)]: Part 1 and Part 2|Plasma concentrations of soluble proteins (PLGF, TGFB1, VEGF-A) may be associated with tumor angiogenesis or tumor physiology and may correlate with efficacy or biological activity.|Baseline (pre-dose of C1D1), C1D1 6 hours post dosing, C1D22, C2D1, C3D1 and end of treatment (Day 490)|Soluble protein biomarker analysis set included all participants who received at least one dose of study drug with a baseline (pre-dose C1D1) or screening biomarker result, and at least one on-treatment biomarker result for at least one biomarker. “n” signifies those participants who were evaluable at specific time-point.||pg/ml||Standard Deviation|Mean
752257|NCT00557856|Other Pre-specified|Soluble Protein Biomarker [Cluster of Differentiation 106 (CD106), Cluster of Differentiation 54 (CD54), Endoglin]: Part 1 and Part 2|Plasma concentrations of soluble proteins (CD106, CD54 and Endoglin) may be associated with tumor angiogenesis or tumor physiology and may correlate with efficacy or biological activity.|Baseline (pre-dose of C1D1), C1D1 6 hours post dosing, C1D22, C2D1, C3D1 and end of treatment (Day 490)|Soluble protein biomarker analysis set included all participants who received at least one dose of study drug with a baseline (pre-dose C1D1) or screening biomarker result, and at least one on-treatment biomarker result for at least one biomarker. “n” signifies those participants who were evaluable at specific time-point.||pg/ml||Standard Deviation|Mean
752258|NCT00557856|Other Pre-specified|Soluble Protein Biomarker [Angiopoietin-2 (Ang-2), Bone Morphogenetic Protein-9 (BMP-9), Chemokine (C-C Motif) Ligand 2 (CCL2)]: Part 1 and Part 2|Plasma concentrations of soluble proteins (Ang-2, BMP-9, C-C motif) may be associated with tumor angiogenesis or tumor physiology and may correlate with efficacy or biological activity.|Baseline (pre-dose of C1D1), C1D1 6 hours post dosing, C1D22, C2D1, C3D1 and end of treatment (Day 490)|Soluble protein biomarker analysis set included all participants who received at least one dose of study drug with a baseline (pre-dose C1D1) or screening biomarker result, and at least one on-treatment biomarker result for at least one biomarker. “n” signifies those participants who were evaluable at specific time-point.||picogram/milliliter (pg/mL)||Standard Deviation|Mean
752260|NCT00557856|Other Pre-specified|Plasma Decay Half-Life (t1/2): Part 1 and Part 2|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. As per planned analysis, t1/2 was summarized if at least 3 participants had reportable value.|0 hr (pre-dose),0.5,1,1.5,2,5,10,24 hr post-dose on Day (D) 1,3,5,8,11,15,22 of Cycle (C) 1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to cycle 12, 28 days after last dose for dose (up to 3 months after last dose for >=2 mg/kg arms)|Pharmacokinetic analysis set included all participants who received at least one dose of study drug and who had complete sampling for pharmacokinetic profiles for PF-03446962. Here “N” (Number of participants analyzed) signifies those who were evaluable for the measure.||hours||Standard Deviation|Mean
752261|NCT00557856|Secondary|Volume of Distribution: Part 1 and Part 2|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. As per planned analysis, volume of distribution was summarized if at least 3 participants had reportable value.|0 hr (pre-dose),0.5,1,1.5,2,5,10,24 hr post-dose on Day (D) 1,3,5,8,11,15,22 of Cycle (C) 1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to cycle 12, 28 days after last dose for dose (up to 3 months after last dose for >=2 mg/kg arms)|Pharmacokinetic analysis set included all participants who received at least one dose of study drug and who had complete sampling for pharmacokinetic profiles for PF-03446962. Here “N” (Number of participants analyzed) signifies those who were evaluable for the measure.||liter (L)||Standard Deviation|Geometric Mean
752262|NCT00557856|Other Pre-specified|Systemic Clearance(CL): Part 1 and Part 2|CL is a quantitative measure of the rate at which a drug substance is removed from the body. As per planned analysis, CL was summarized if at least 3 participants had reportable value.|0 hr (pre-dose),0.5,1,1.5,2,5,10,24 hr post-dose on Day (D) 1,3,5,8,11,15,22 of Cycle (C) 1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to cycle 12, 28 days after last dose for dose (up to 3 months after last dose for >=2 mg/kg arms)|Pharmacokinetic analysis set included all participants who received at least one dose of study drug and who had complete sampling for pharmacokinetic profiles for PF-03446962. Here “N” (Number of participants analyzed) signifies those who were evaluable for the measure.||liter/hour (L/hr)||Standard Deviation|Geometric Mean
752263|NCT00557856|Other Pre-specified|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast): Part 1 and Part 2|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).|0 hr (pre-dose),0.5,1,1.5,2,5,10,24 hr post-dose on Day (D) 1,3,5,8,11,15,22 of Cycle (C) 1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to cycle 12, 28 days after last dose for dose (up to 3 months after last dose for >=2 mg/kg arms)|Pharmacokinetic analysis set included all participants who received at least one dose of study drug and who had complete sampling for pharmacokinetic profiles for PF-03446962. Here “N” (Number of participants analyzed) signifies those who were evaluable for the measure.||ng*hr/mL||Standard Deviation|Geometric Mean
752264|NCT00557856|Other Pre-specified|Area Under the Curve From Time Zero to Day 28 [AUC (0-28)]: Part 1 and Part 2|AUC (0-28) = Area under the plasma concentration versus time curve from time zero (pre-dose) to Day 28 (0-28).|0 hr (pre-dose),0.5,1,1.5,2,5,10,24 hr post-dose on Day (D) 1,3,5,8,11,15,22 of Cycle (C) 1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to cycle 12, 28 days after last dose for dose (up to 3 months after last dose for >=2 mg/kg arms)|Pharmacokinetic analysis set included all participants who received at least one dose of study drug and who had complete sampling for pharmacokinetic profiles for PF-03446962. Here “N” (Number of participants analyzed) signifies those who were evaluable for the measure.||nanogram*hour/milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
752265|NCT00557856|Other Pre-specified|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-03446962: Part 1 and Part 2||0 hr (pre-dose),0.5,1,1.5,2,5,10,24 hr post-dose on Day (D) 1,3,5,8,11,15,22 of Cycle (C) 1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to cycle 12, 28 days after last dose for dose (up to 3 months after last dose for >=2 mg/kg arms)|Pharmacokinetic analysis set included all participants who received at least one dose of study drug and who had complete sampling for pharmacokinetic profiles for PF-03446962. Here “N” (Number of participants analyzed) signifies those who were evaluable for the measure.||hour||Full Range|Median
752266|NCT00557856|Other Pre-specified|Minimum Observed Serum Trough Concentration (Cmin): Part 1 and Part 2||0 hr (pre dose), 1 hr post-dose C1D1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to C12|Pharmacokinetic analysis set included all participants who received at least one dose of study drug and who had complete sampling for pharmacokinetic profiles for PF-03446962. Here “N” (Number of participants analyzed) signifies those who were evaluable for the measure and “n” signifies those participants who were evaluable at specific time-point.||ng/mL||Standard Deviation|Geometric Mean
752267|NCT00557856|Other Pre-specified|Maximum Observed Serum Concentration (Cmax): Part 1 and Part 2||0 hr (pre-dose),0.5,1,1.5,2,5,10,24 hr post-dose on Day (D) 1,3,5,8,11,15,22 of Cycle (C) 1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to cycle 12, 28 days after last dose for dose (up to 3 months after last dose for >=2 mg/kg arms)|Pharmacokinetic analysis set included all participants who received at least one dose of study drug and who had complete sampling for pharmacokinetic profiles for PF-03446962.||nanogram/milliliter (ng/mL)||Standard Deviation|Geometric Mean
752268|NCT00557856|Secondary|Time To Progression (TTP): Part 2|Time in months from start of treatment to first documentation of objective tumor progression. TTP was calculated as (first event date or last known progression-free date minus the date of treatment plus 1) divided by 30.44. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD] per RECIST). PD: >=20% increase in the sum of the LD of the target lesions taking as a reference the smallest sum of the LD or the appearance of one or more new lesions and as unequivocal progression of existing non-target lesions, or the appearance of >=1 new lesions. TTP was calculated out of the participants participating in the exploratory phase.|Baseline then 6 weeks after Cycle 1 of Day1 thereafter every 6 weeks up to Day 490|Safety population included all participants who received at least one dose of study drug.||months||Full Range|Median
752292|NCT00558025|Primary|Percentage of Patients Who Successfully Switched From Pramipexole Immediate Release (IR) to Pramipexole ER After a Possible Dose Adaptation, Full Analysis Set (FAS), Last Observation Carried Forward (LOCF)|A successful switch was defined by no change of the Unified Parkinson's Disease Rating Scale (UPDRS) II+III by more than 15% from baseline to week 9, UPDRS II+III score ranging from 0 (no impairment) to 160 (worst impairment)|from baseline to week 9|Full Analysis Set (FAS), all randomized patients that received treatment and had baseline and post baseline measurements for the primary endpoint||Percentage of participants|||Number
752269|NCT00557856|Secondary|Percentage of Participants With Disease Control: Part 2|Participants who achieved either a confirmed complete Response or confirmed partial response or a Stable disease lasting at least 12 weeks from the first dose was defined as achieving disease control. Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR: disappearance of all target lesions and non-target lesions. PR: >=30 % decrease in sum of the longest diameters (LD) of the target lesions taking as a reference the baseline sum LD and stable disease: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as a reference the smallest sum of the LD according to RECIST associated to non-progressive disease response for non-target lesions. Percentage of participants achieving disease control was calculated out of the participants participating in the exploratory phase.|Baseline then 6 weeks after Cycle 1 of Day1 thereafter every 6 weeks up to Day 490|Response-evaluable set included all participants who started Cycle 1 with an adequate baseline tumor assessment.||percentage of participants||90% Confidence Interval|Number
752270|NCT00557856|Secondary|Percentage of Participants With Objective Response: Part 1 and Part 2|Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR defined as disappearance of all target lesions and non-target lesions. PR defined as >=30 % decrease in sum of the longest diameters (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non-target lesions.|Baseline then 6 weeks after Cycle 1 of Day1 thereafter every 6 weeks up to Day 490|Response-evaluable set included all participants who received at least 1 dose of study drug with an adequate baseline tumor assessment.||percentage of participants||90% Confidence Interval|Number
752271|NCT00557856|Secondary|Number of Participants With Laboratory Abnormalities: Part 1 and Part 2|Laboratory tests included hematology (hemoglobin, lymphocytes absolute [abs], neutrophils abs, platelets, white blood cells) and chemistry (alanine aminotransferase, alkaline phosphatase, amylase, aspartate aminotransferase, bilirubin, creatinine, hypercalcemia, hyperglycemia, hyperkalemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypokalemia, hyponatremia, hypophosphatemia, lipase). Assays were based on National Cancer Institute [NCI] Common Terminology Criteria for AE (CTCAE) grading scale for AEs (grade 1 [mild AE: did not cause any significant problem, no dose adjustment required]; grade 2 [moderate AE: caused problem that did not interfere significantly with usual activities or the clinical status, dose adjustment needed due to adverse event]; grade 3 [severe AE: caused problem that interfered significantly with usual activities or the clinical status, study drug stopped due to adverse event] and grade 4 [life threatening AE]). Overall data of the 4 grades is reported.|Cycle 1 of Day 1 up to 28 days after the last dose of treatment|Safety population included all enrolled participants who received at least one dose of study drug.||participants|||Number
752272|NCT00557856|Secondary|Time to Treatment-Emergent Adverse Events (AEs): Part 1 and Part 2|Total time from onset of adverse event till the event is resolved. Treatment-emergent events were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Cycle 1 of Day 1 up to 28 days after the last dose of treatment|Data for timing was reported in individual participant listing for every adverse event (AE) and mentioned for description of narrative of Serious AEs but was not statistically summarized for analysis on the entire safety population, as planned.|||||
752273|NCT00557856|Secondary|Number of Participants With Treatment Emergent Adverse Events (AEs) Based on Seriousness: Part 1 and Part 2|AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Seriousness of an AE was assessed as serious adverse event (SAE) and non-serious adverse event (non-SAE). An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Non-SAE included all AE minus SAE. Treatment-emergent events were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Cycle 1 of Day 1 up to 28 days after the last dose of treatment|Safety population included all enrolled participants who received at least one dose of study drug.||participants|||Number
752274|NCT00557856|Secondary|Number of Participants With Treatment Emergent Adverse Events (AEs) Based on Severity: Part 1 and Part 2|AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed according to severity; Grade 0 (no change from normal); grade 1 (mild AE which did not cause any significant problem, no dose adjustment required); grade 2 (moderate AE which caused problem that did not interfere significantly with usual activities or the clinical status, dose adjustment needed due to adverse event); grade 3 (severe AE which caused problem that interfered significantly with usual activities or the clinical status, study drug stopped due to adverse event); grade 4 (life threatening AE) and grade 5 (death). Treatment-emergent events were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Cycle 1 of Day 1 up to 28 days after the last dose of treatment|Safety population included all enrolled participants who received at least one dose of study drug.||participants|||Number
752275|NCT00557856|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs): Part 1 and Part 2|An all causality AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Treatment-related AEs was any untoward medical occurrence in participant that was attributed to study drug. Treatment-emergent events were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Cycle 1 of Day 1 up to 28 days after the last dose of treatment|Safety population included all enrolled participants who received at least one dose of study drug.||participants|||Number
752276|NCT00557856|Primary|Recommended Phase 2 Dose (RP2D): Part 1|RP2D was defined as the lower dose level to MTD based on the safety profile.|Baseline up to 42 days after the start of each increased treatment dose|The MTD analysis set included all participants who were enrolled in the dose escalation part of the study and received at least 1 dose of study drug.||mg/kg|||Number
752318|NCT00558272|Secondary|N-desmethyl Metabolite of Saracatinib: Time to Cssmax (Tmax)||Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29|||h||Full Range|Median
752277|NCT00557856|Primary|Maximum Tolerated Dose (MTD): Part 1|MTD was defined as highest dose level for which no more than 1 participant in a dose cohort experienced DLT and at least 2 out of 3/6 participants in the next higher dose. DLT was defined as any of the following events occurring during the first 42 days of study drug: any grade greater than or equal to 3 hematologic and non-hematologic toxicity, all non-disease-related adverse events (AEs).|Baseline up to 42 days after the start of each increased treatment dose|The MTD analysis set included all participants who were enrolled in the dose escalation part of the study and received at least 1 dose of study drug.||milligram/kilogram (mg/kg)|||Number
752278|NCT00557947|Secondary|Cosmetic Outcome|"Modified Hollander Cosmesis Scale overall outcome score in which a score of 0 corresponds to a good outcome versus a 1-6 to a poor outcome. The proportions of incisions with good outcomes were then compared to those with poor outcomes.
Reference: Hollander JE, Singer AJ, Valentine S, Thode HC Jr, Henry MC. Wound registry:development and validation. Ann Emerg Med. 1995;25:675–85."|12 month|There were 49 participants who consented to and ultimately attended all follow-up visits for evaluation of cosmetic outcome.||Incisions with good outcome|||Number
752279|NCT00557947|Secondary|Cosmetic Outcome|"Modified Hollander Cosmesis Scale overall outcome score in which a score of 0 corresponds to a good outcome versus a 1-6 to a poor outcome. The proportions of incisions with good outcomes were then compared to those with poor outcomes.
Reference: Hollander JE, Singer AJ, Valentine S, Thode HC Jr, Henry MC. Wound registry:development and validation. Ann Emerg Med. 1995;25:675–85."|6 months|There were 50 participants who consented to and ultimately attended all follow-up visits for evaluation of cosmetic outcome.||Incisions with good outcomes|||Number
752280|NCT00557947|Secondary|Cosmetic Outcome|"Modified Hollander Cosmesis Scale overall outcome score in which a score of 0 corresponds to a good outcome versus a 1-6 to a poor outcome. The proportions of incisions with good outcomes were then compared to those with poor outcomes.
Reference: Hollander JE, Singer AJ, Valentine S, Thode HC Jr, Henry MC. Wound registry:development and validation. Ann Emerg Med. 1995;25:675–85."|90 days post-procedure|There were 50 participants who consented to and ultimately attended follow-up visits for evaluation of cosmetic outcome.||Incisions with good outcome|||Number
752281|NCT00557947|Secondary|Time Required to Close the Final Skin Layer|Time to close final skin layer for each incision segment.|Intraoperative|The analysis is based upon the Intent To Treat population||minutes||Standard Deviation|Mean
752282|NCT00557947|Primary|Continuous Apposition of the Skin Edges Without Wound Dehiscence or Re-closure as Measured by the Upper Limit of 95% Confidence Interval in Proportion of Successes for Each Groups.|Equivalence is demonstrated if the upper limit of the 95% confidence interval (when subtracting the percentage of DERMABOND PROTAPE successful subjects from the percentage of INTRADERMAL SUTURE successful subjects) does not exceed 12%.|12-25 days post-operation|The primary analysis is based upon intent to treat population.||Participants|||Number
752283|NCT00558012|Primary|Bone Mineral Density (BMD) of the Total Hip and Spine|BMD is the bone mineral density of the lumbar spine and total hip measured using dual-energy xray absorptiometry (DXA) scan|Baseline, 12 months, 24 month|Number of patients that completed a DXA at 12 months. At 24 months 60 in active treatment group and 72 in placebo group completed a DXA.||Percent change||Standard Error|Mean
752284|NCT00558025|Secondary|Final Pramipexole Dose (mg) After 9 Weeks, Treated Set|The mean final daily Pramipexole dose is displayed|Week 9|Treated Set (TS) includes all patients randomized and who received treatment||mg||Standard Deviation|Mean
752285|NCT00558025|Secondary|Pramipexole Dose Adaptation, FAS (LOCF)|Patients with increase in daily Pramipexole dose on FAS|Week 9|Full Analysis Set (FAS), all randomized patients that received treatment and had baseline and post baseline measurements for the primary endpoint||participants|||Number
752286|NCT00558025|Secondary|Patient Global Impression - Improvement (PGI-I), FAS (LOCF)|Patient Global Impression - Improvement on FAS, PGI-I was rated from 1: very much better, to 7: very much worse, PGI-I responder are defined as being rated as 'unchanged', 'minimally better', 'much better', or 'very much better', PGI-I non-responder are defined as being rated as 'minimally worse', 'much worse', or 'very much worse'|Week 9|Full Analysis Set (FAS), all randomized patients that received treatment and had baseline and post baseline measurements for the primary endpoint||participants|||Number
752287|NCT00558025|Secondary|Clinical Global Impression - Improvement (CGI-I), FAS (LOCF)|Clinical Global Impression - Improvement on FAS, CGI-I was rated from 1: very much improved, to 7: very much worse, CGI-I responder are defined as being rated as 'unchanged', 'minimally improved', 'much improved', or 'very much improved', CGI-I non-responder are defined as being rated 'minimally worse', 'much worse' or 'very much worse'|Week 9|Full Analysis Set (FAS), all randomized patients that received treatment and had baseline and post baseline measurements for the primary endpoint||participants|||Number
752288|NCT00558025|Secondary|Change From Baseline in UPDRS Part III Total Score at Week 9, FAS (LOCF)|Unified Parkinson's Disease Rating Scale part III total score on FAS, week 9 - baseline, UPDRS II+III score ranging from 0 (no impairment) to 108 (worst impairment)|Baseline and week 9|Full Analysis Set (FAS), all randomized patients that received treatment and had baseline and post baseline measurements for the primary endpoint||Score on Scale||Standard Error|Least Squares Mean
752289|NCT00558025|Secondary|Change From Baseline in UPDRS Part II Total Score at Week 9, FAS (LOCF)|Unified Parkinson's Disease Rating Scale part II total score on FAS, Week 9 - baseline, UPDRS II score ranging from 0 (no impairment) to 52 (worst impairment)|Baseline and week 9|Full Analysis Set (FAS), all randomized patients that received treatment and had baseline and post baseline measurements for the primary endpoint||Score on Scale||Standard Error|Mean
752290|NCT00558025|Secondary|Change From Baseline in UPDRS Part II+III Total Score at Week 9, FAS (LOCF)|Unified Parkinson's Disease Rating Scale part II+III total score on FAS, Week 9 - baseline, UPDRS II+III score ranging from 0 (no impairment) to 160 (worst impairment)|Baseline and week 9|Full Analysis Set (FAS), all randomized patients that received treatment and had baseline and post baseline measurements for the primary endpoint||Score on scale||Standard Error|Least Squares Mean
752291|NCT00558025|Secondary|Percentage of Patients Who Successfully Switched From Pramipexole IR to Pramipexole ER With no Dose Adaptation, FAS (LOCF)|A successful switch was defined by no change of the UPDRS II+III by more than 15% from baseline to week 4, UPDRS II+III score ranging from 0 (no impairment) to 160 (worst impairment).|from baseline to week 4|Full Analysis Set (FAS), all randomized patients that received treatment and had baseline and post baseline measurements for the primary endpoint||Percentage of participants|||Number
752293|NCT00558064|Secondary|Clinically Relevant Abnormalities for Blood Chemistry, Pulse Rate, Laboratory Parameters and ECG|Clinical relevant abnormalities for blood chemistry, pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.|First administration of randomised treatment to 24 hours post last dose of randomised treatment|Treated set: Patients randomised to the double-blind treatment period who took at least one dose either of T40+A5 or A5 during the double-blind treatment period.||participants|||Number
752294|NCT00558064|Secondary|Percentage of Patients With Optimal, Normal or High Normal Blood Pressure at 8 Weeks (0 Percent at Baseline)|"Optimal, normal, high normal blood pressure were defined as follows:
Optimal: Systolic blood pressure (SBP) < 120 mmHg and diastolic blood pressure (DBP) < 80 mmHg
Normal: SBP >= 120 mmHg or DBP >= 80 mmHg and SBP < 130 mmHg and DBP < 85 mmHg
High normal: SBP >= 130 mmHg or DBP >= 85 mmHg and SBP < 140 mmHg and DBP < 90 mmHg
No: SBP >= 140 mmHg and DPB >= 90 mmHg"|8 weeks|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.||percentage of patients|||Number
752295|NCT00558064|Secondary|Percentage of Patients Who Achieved an Adequate Response in Seated Trough Systolic Blood Pressure at 8 Weeks|Adequate response defined that seated trough systolic blood pressure was <140 mmHg or decreased from reference baseline by >=20 mmHg at 8 weeks (0 percent at baseline)|8 weeks|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.||percentage of patients|||Number
752296|NCT00558064|Secondary|Percentage of Patients Who Achieved an Adequate Response in Seated Trough Diastolic Blood Pressure at 8 Weeks (0 Percent at Baseline)|Adequate response defined that seated trough diastolic blood pressure was <90 mmHg or decreased from reference baseline by >=10 mmHg at 8 weeks|8 weeks|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.||percentage of patients|||Number
752297|NCT00558064|Secondary|Percentage of Patients With Seated Trough Systolic Blood Pressure Less Than 140 mmHg at 8 Weeks (0 Percent at Baseline)|Seated trough systolic blood pressure defined as blood pressure in a sitting position no later than 24 hours after the last intake|8 weeks|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.||percentage of patients|||Number
752298|NCT00558064|Secondary|Percentage of Patients With Seated Trough Diastolic Blood Pressure Less Than 90 mmHg at 8 Weeks (0 Percent at Baseline)|Seated trough diastolic blood pressure defined as blood pressure in a sitting position no later than 24 hours after the last intake|8 weeks|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.||percentage of patients|||Number
752299|NCT00558064|Secondary|Reduction From Reference Baseline in Mean Seated Systolic Blood Pressure at Trough (24-hour Post-dosing)|The mean of the change value was least square mean which was calculated by analysis of covariance with factor treatment and center, and covariate baseline.|Baseline and 8 Weeks|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.||mmHg||Standard Error|Mean
752300|NCT00558064|Primary|Reduction From Reference Baseline in Mean Seated Diastolic Blood Pressure at Trough (24-hour Post-dosing)|The mean of the change value was least square mean which was calculated by analysis of covariance with factor treatment and center, and covariate baseline.|Baseline and 8 Weeks|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.||mmHg||Standard Error|Mean
752301|NCT00558103|Secondary|Overall Survival|Overall survival is defined as the time from randomization until death due to any cause. For participants who did not die, time to death was censored at the time of last contact.|From the date of randomization until the date of death due to any cause, assessed for up to 163 weeks|mITT1 and mITT2 Populations||months||90% Confidence Interval|Median
752302|NCT00558103|Secondary|Progression-free Survival, Defined as the Interval Between the Date of Randomization and the Earliest Date of Disease Progression (PD) or Death Due to Any Cause (Defined by an Investigator Review of Lesions Based on RECIST and Cutaneous Disease)|RECIST-based response assessment was done at Wks 4 and 8 and every 8 weeks thereafter. Cutaneous disease assessment was done at Wk 4 and every 4 weeks thereafter. OR was evaluated when the skin and RECIST assessments coincided. Per RECIST, PD is >=20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since treatment started or the appearance of >=1 new lesion and/or unequivocal progression of existing non-target lesions. Cutaneous disease contained non-measurable and measurable skin disease, which was assessed by skin assessment tools.|From the date of the randomization until the earliest date of disease progression or death due to any cause, assessed for up to 66 weeks|mITT1 and mITT2 Populations||weeks||90% Confidence Interval|Median
752303|NCT00558103|Secondary|Median Duration of Response,Defined as the First Documented Evidence of CR or PR Until the First Documentation of Disease Progression|RECIST-based response assessment was done at Wks 4 and 8 and every 8 weeks thereafter. Cutaneous disease assessment was done at Wk 4 and every 4 weeks thereafter. OR was evaluated when the skin and RECIST assessments coincided. Per RECIST, PD is >=20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since treatment started or the appearance of >=1 new lesion and/or unequivocal progression of existing non-target lesions. Cutaneous disease contained non-measurable and measurable skin disease, which was assessed by skin assessment tools.|From the date of the first documented evidence of CR or PR until the date of the first documented disease progression or death, assessed for up to 62 weeks|mITT1 and mITT2 Populations. Only participants who achieved a response of CR or PR during the study were analyzed. For participants who did not progress or die, duration of response was censored on the date of the last adequate assessment.||weeks||90% Confidence Interval|Median
752304|NCT00558103|Primary|Number of Participants With Overall Response (OR), Defined as Those Participants Achieving Complete Response (CR) or Partial Response (PR), Assessed Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 and Cutaneous Lesions|RECIST-based response assessment was done at Weeks (Wks) 4 and 8 and every 8 weeks thereafter. Cutaneous disease assessment was done at Wk 4 and every 4 weeks thereafter. OR was evaluated when the skin and RECIST assessments coincided. Per RECIST, CR is the disappearance of all target and non-target lesions; PR is at least a 30 percent (%) decrease in the sum of the longest diameter (LD) of target lesions, taking as a reference the baseline sum LD. Cutaneous disease contained non-measurable and measurable skin disease, which was assessed by skin assessment tools.|Baseline until disease progression/recurrence was documented, assessed for up to 66 weeks|Modified Intent-to-Treat (mITT) Population: all randomized participants who received at least one dose of study treatment. The mITT1 Population was used for cohort 1; the mITT2 Population used for cohort 2.||participants|||Number
752305|NCT00558246|Secondary|Cosmetic Outcome|"Modified Hollander Cosmesis Scale overall outcome score in which a score of 0 corresponds to a good outcome versus a 1-6 to a poor outcome. The proportions of breasts with good outcomes were then compared to those with poor outcomes in each group.
Reference: Hollander JE, Singer AJ, Valentine S, Thode HC Jr, Henry MC. Wound registry:development and validation. Ann Emerg Med. 1995;25:675–85."|12 months|There were 59 participants who completed all follow-up visits and cosmetic evaluations.||Incisions with good outcome|||Number
752306|NCT00558246|Secondary|Cosmetic Outcome|"Modified Hollander Cosmesis Scale overall outcome score in which a score of 0 corresponds to a good outcome versus a 1-6 to a poor outcome. The proportions of breasts with good outcomes were then compared to those with poor outcomes in each group.
Reference: Hollander JE, Singer AJ, Valentine S, Thode HC Jr, Henry MC. Wound registry:development and validation. Ann Emerg Med. 1995;25:675–85."|6 months|There were 60 participants who completed all follow-up visits and cosmetic evaluations.||Incisions with good outcome|||Number
752307|NCT00558246|Secondary|Cosmetic Outcome|"Modified Hollander Cosmesis Scale overall outcome score in which a score of 0 corresponds to a good outcome versus a 1-6 to a poor outcome. The proportions of breasts with good outcomes were then compared to those with poor outcomes in each group.
Reference: Hollander JE, Singer AJ, Valentine S, Thode HC Jr, Henry MC. Wound registry:development and validation. Ann Emerg Med. 1995;25:675–85."|90 days post-procedure|There were 60 participants who consented to and ultimately attended all follow-up visits for evaluation of cosmetic outcome.||Incisions with good outcome|||Number
752308|NCT00558246|Secondary|Time (Minutes) Required to Close the Final Skin Layer|Overall time required to close final skin layer on each breast.|Intraoperative|The analysis is based upon the Intent to Treat population.||minutes||Standard Deviation|Mean
752309|NCT00558246|Primary|Continuous Apposition of the Skin Edges Without Wound Dehiscence or Re-closure as Measured by the Upper Limit of 95% Confidence Interval in Proportion of Successes for Each Groups.|Equivalence was demonstrated if the upper limit of the 95% confidence interval (when subtracting the percentage of DERMABOND PROTAPE successful subjects from the percentage of INTRADERMAL SUTURE successful subjects) did not exceed 12 percent.|12-25 days|The primary analysis is based upon intent to treat population.||Participants|||Number
752310|NCT00558259|Secondary|Laboratory Measures, Especially Liver Function Tests (LFTs)|Number of participants with possible clinically significant abnormalities during the treatment period.|6 months|FAS − As Treated Assignment||participants|||Number
752311|NCT00558259|Secondary|Centrally Confirmed Cardiovascular Events During the Treatment Period|Cardiovascular events that occurred during the treatment period + 3 days were summarised by treatment groups.|6 months|FAS and analysed as treated. There were 3 participants who were randomised to placebo but treated with dabigatran only.||participants|||Number
752312|NCT00558259|Secondary|Centrally Confirmed Bleeding Event During the Treatment Period|"Major bleeding events (MBE) had to fulfil at least 1 of the following criteria:
Fatal bleeding
Associated with a fall in haemoglobin of ≥2 g/dL
Led to the transfusion of ≥2 units packed cells or whole blood
Occurred in a critical site: intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal
Other clinically relevant bleeding was defined as overt bleeding not meeting the criteria for an MBE but associated with medical intervention, unscheduled contact with a physician, (temporary) cessation of study treatment, or associated with discomfort such as pain, or impairment of activities of daily life.
Examples of these bleedings were:
Bleeding that compromised haemodynamics
Bleeding that led to hospitalisation
Trivial bleeding events were defined as all other bleeding events that did not fulfil the criteria of MBEs or CRBEs.
All bleeding events include MBEs, CRBEs, and trivial bleeding events."|6 months|FAS and analysed as treated. There were 3 participants who were randomised to placebo but treated with dabigatran only.||participants|||Number
752313|NCT00558259|Secondary|Centrally Confirmed Unexplained Deaths During the Intended Treatment Period|Number of participants with centrally confirmed unexplained deaths during the intended treatment period were described.|6 months|FAS and analysed as randomised.||participants|||Number
752314|NCT00558259|Secondary|Centrally Confirmed Symptomatic Pulmonary Embolism (PE) Events During the Intended Treatment Period|Number of participants with centrally confirmed symptomatic pulmonary embolism (PE) events during the intended treatment period were described.|6 months|FAS and analysed as randomised.||Participants|||Number
752315|NCT00558259|Secondary|Centrally Confirmed Symptomatic Recurrent Deep Venous Thrombotic (DVT) Events During the Intended Treatment Period|Number of the participants with centrally confirmed symptomatic recurrent deep venous thrombotic (DVT) events during the intended treatment period were described.|6 months|FAS and analysed as randomised.||Participants|||Number
752316|NCT00558259|Secondary|Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Excluding Unexplained Death During the Intended Treatment Period|Symptomatic recurrent VTE is the composite of recurrent deep vein thrombosis (DVT) , fatal or non-fatal pulmonary embolism (PE). Whilst the endpoint is time to event, the measured values present the number of participant with event and the hazard ratio presents the time to event.|6 months|FAS and analysed as randomised.||Participants|||Number
752317|NCT00558259|Primary|Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Including Unexplained Death During the Intended Treatment Period|Symptomatic recurrent VTE is the composite of recurrent deep vein thrombosis (DVT) , fatal or non-fatal pulmonary embolism (PE). Whilst the endpoint is time to event, the measured values present the number of participant with event and the hazard ratio presents the time to event.|6 months|Full analysis set (FAS) and analysed as randomised. FAS is defined as randomised and treated.||Participants|||Number
752327|NCT00558272|Secondary|Saracatinib: Area Under the Curve at Steady State (AUCss)|Previous studies have shown that saracatinib reduces osteoclast function and bone resorption. Bone turnover, the combined result of bone formation and bone resorption, can be assessed in real time by measuring specific markers of bone turnover in serum and in urine. These markers were assessed in a study of patients with metastatic bone disease treated with saracatinib. Specific assays are available to quantitate these markers in serum and urine. In this study the effects of saracatinib on bone turnover were compared with the effects of zoledronic acid, a marketed drug known to inhibit bone resorption in cancer patients with bone metastatses.|Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29|||ng•hr/ml||Full Range|Median
752328|NCT00558272|Secondary|Percentage Change From Baseline in Urine Alpha-alpha C-terminal Cross-linking Telopeptide of Type I Collagen Normalised to Creatinine (aaCTx/Cr) at Week 4|Result at Week 4 minus result at baseline as a percentage of the result at baseline, based on log transformed data. Back transformation of the least squares (LS) mean.|Baseline to Week 4|The number of participants analyzed reflected the number of paired serum samples per participant that yielded valid assay results, not the total number of participants or completers. The number of evaluable paired serum samples will therefore be a subset of the total number of participants.||Percentage change in aaCTx/Cr||95% Confidence Interval|Geometric Mean
752329|NCT00558272|Secondary|Percentage Change From Baseline in Urine N-terminal Cross-linking Telopeptide of Type I Collagen Normalised to Creatinine (NTx/Cr) at Week 4|Result at Week 4 minus result at baseline as a percentage of the result at baseline, based on log transformed data. Back transformation of the least squares (LS) mean.|Baseline to Week 4|The number of participants analyzed reflected the number of paired serum samples per participant that yielded valid assay results, not the total number of participants or completers. The number of evaluable paired serum samples will therefore be a subset of the total number of participants.||Percentage change in NTx/Cr||95% Confidence Interval|Geometric Mean
752330|NCT00558272|Secondary|Percentage Change From Baseline in Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b) at Week 4|Result at Week 4 minus result at baseline as a percentage of the result at baseline, based on log transformed data. Back transformation of the least squares (LS) mean.|Baseline to Week 4|The number of participants analyzed reflected the number of paired serum samples per participant that yielded valid assay results, not the total number of participants or completers. The number of evaluable paired serum samples will therefore be a subset of the total number of participants.||Percentage change in TRAP5b||95% Confidence Interval|Geometric Mean
752331|NCT00558272|Secondary|Percentage Change From Baseline in Serum N-terminal Propeptide of Type I Procollagen (PINP) at Week 4|Result at Week 4 minus result at baseline as a percentage of the result at baseline, based on log transformed data. Back transformation of the least squares (LS) mean.|Baseline to Week 4|The number of participants analyzed reflected the number of paired serum samples per participant that yielded valid assay results, not the total number of participants or completers. The number of evaluable paired serum samples will therefore be a subset of the total number of participants.||Percentage change in PINP||95% Confidence Interval|Geometric Mean
752332|NCT00558272|Secondary|Percentage Change From Baseline in Serum Cross-linked C-terminal Telopeptide of Type I Collagen (ICTP) at Week 4|Result at Week 4 minus result at baseline as a percentage of the result at baseline, based on log transformed data. Back transformation of the least squares (LS) mean.|Baseline to Week 4|The number of participants analyzed reflected the number of paired serum samples per participant that yielded valid assay results, not the total number of participants or completers. The number of evaluable paired serum samples will therefore be a subset of the total number of participants.||Percentage change in ICTP||95% Confidence Interval|Geometric Mean
752333|NCT00558272|Secondary|Percentage Change From Baseline in Serum Bone-specific Alkaline Phosphatase (bALP) at Week 4|Result at Week 4 minus result at baseline as a percentage of the result at baseline, based on log transformed data. Back transformation of the least squares (LS) mean.|Baseline to Week 4|The number of participants analyzed reflected the number of paired serum samples per participant that yielded valid assay results, not the total number of participants or completers. The number of evaluable paired serum samples will therefore be a subset of the total number of participants.||Percentage change in bALP||95% Confidence Interval|Geometric Mean
752334|NCT00558272|Primary|Percentage Change From Baseline in Serum Beta C-terminal Cross-linking Telopeptide of Type I Collagen (betaCTX) at Week 4|Result at Week 4 minus result at baseline as a percentage of the result at baseline, based on log transformed data. Back transformation of the least squares (LS) mean.|Baseline to Week 4|The number of participants analyzed reflected the number of paired serum samples per participant that yielded valid assay results, not the total number of participants or completers. The number of evaluable paired serum samples will therefore be a subset of the total number of participants.||Percentage change in betaCTX||95% Confidence Interval|Geometric Mean
752335|NCT00564447|Primary|Assessment of Pharmacokinetic Parameters|Conjunctiva Concentration of Azithromycin and Moxifloxacin|Over 24 hours|||μg/g||Standard Deviation|Mean
752336|NCT00564447|Primary|Assessment of Pharmacokinetic Parameters||Up to 24 hours||||||
752337|NCT00564486|Secondary|The Number of Subjects Reporting a Treatment Emergent Serious Adverse Event|"The number of subjects who reported at least one treatment emergent SAE during the study.
A Serious Adverse Event is defined as any untoward medical occurrence at any dose of blinded study medication that:
results in death
is life-threatening
requires inpatient hospitalization or causes prolongation of existing hospitalization
results in persistent or significant disability/incapacity
is a congenital anomaly/birth defect
is an important medical event"|First dose to 30 days after last dose of study medication.|All analyses were conducted on the safety population, which included those subjects who received any portion of a dose of study medication.||Subjects|||Number
752338|NCT00564486|Secondary|The Number of Subjects Reporting a Treatment Emergent Adverse Event|"Number of subjects who experienced at least one treatment emergent adverse event (TEAE).
A TEAE is an adverse event that occurs on or after the first dose of study medication (T0)."|First dose through 7 day follow up|All analyses of safety were conducted on the safety population, which included those subjects who received any portion of a dose of study medication.||Subjects|||Number
752437|NCT00568958|Secondary|Number of Drinks Per Drinking Day|Self-reported drinking was primarily obtained through diary data, with the Timeline Follow-Back Interview (TLFB) used to replace missing data at baseline and at each biweekly visit over the 8-weeks.The eight weeks follow-up measure is summarized across all biweekly visits.|8 Weeks|||drinks per drinking day||Standard Deviation|Mean
752339|NCT00564486|Secondary|Sum Pain Intensity Difference - Baseline to 24 Hours (SPID24), 650 mg IV Acetaminophen vs. Placebo (PI Was Measured at the Timepoints of T0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 18, 20, and 24 Hours.)|"Sum of Pain Intensity (PI) as measured by the 100 mm long Visual Analogue Scale (VAS) over 24 hours after treatment subtracting the Baseline VAS score.The 100 mm VAS was drawn on a pain ruler and labeled at it's left end with 0 = No Pain' and its right end with '100 = Worst Pain Imaginable.' Subjects placed a mark on the scale to represent their perceived pain. The score was the distance in mm from the left end of the VAS to the point where the subject's mark crossed the line. PI difference from baseline was calculated at each assessment over a 24 hour period."|Baseline to 24 hrs|Included modified Intent To Treat group (mITT), defined as randomized subjects who received at least one complete infusion of study medication prior to receiving rescue medication.||Units on a scale||Standard Deviation|Mean
752340|NCT00564486|Primary|Sum Pain Intensity Difference - Baseline to 24 Hours (SPID24), 1 g IV Acetaminophen vs. Placebo (PI Was Measured at the Timepoints of T0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 18, 20, and 24 Hours.)|"Pain Intensity (PI) as measured by a 100 millimeter (mm) long Visual Analogue Scale (VAS) over 24 hours after treatment minus the Baseline VAS score. The 100 mm VAS was drawn on a pain ruler and labeled at its left end with '0 = No Pain' and with 100 = Worst Pain Imaginable' at its right end. Subjects placed a mark on the scale to represent their perceived pain. The score was the distance in mm from the left end of the VAS to the point where the subject's mark crossed the line. PI at baseline was compared to the PI at each timepoint and differences were summed over the 24 hour time period."|Baseline to 24 hrs|All efficacy analyses were conducted using the modified intent-to-treat (mITT) population, defined as those subjects who received at least one complete infusion of study medication prior to requesting rescue medication.Worst Observation Carried Forward (WOCF) imputation was applied after first rescue medication.||Units on a scale||Standard Deviation|Mean
752341|NCT00564629|Secondary|WSTD6|This outcome measure is a statistical analysis of WSTD6, which is the weighted sum of temperature differences from the subject's core temperature at each assessment time point through the first 6 hours compared with the subject's core temperature at T0, weighted by the time elapsed between each 2 consecutive time points. The subject's core temperature was measured using an ingestible temperature monitoring capsule and associated data recorder.|0-6 hours|||degrees Celsius||Standard Deviation|Mean
752342|NCT00564629|Secondary|WSTD5|This outcome measure is a statistical analysis of WSTD5, which is the weighted sum of temperature differences from the subject's core temperature at each assessment time point through the first 5 hours compared with the subject's core temperature at T0, weighted by the time elapsed between each 2 consecutive time points. The subject's core temperature was measured using an ingestible temperature monitoring capsule and associated data recorder.|0-5 hours|||degrees Celsius||Standard Deviation|Mean
752343|NCT00564629|Secondary|WSTD4|This outcome measure is a statistical analysis of WSTD4, which is the weighted sum of temperature differences from the subject's core temperature at each assessment time point through the first 4 hours compared with the subject's core temperature at T0, weighted by the time elapsed between each 2 consecutive time points. The subject's core temperature was measured using an ingestible temperature monitoring capsule and associated data recorder.|0-4 hours|||degrees Celsius||Standard Deviation|Mean
752344|NCT00564629|Secondary|WSTD3|This outcome measure is a statistical analysis of WSTD3, which is the weighted sum of temperature differences from the subject's core temperature at each assessment time point through the first 3 hours compared with the subject's core temperature at T0, weighted by the time elapsed between each 2 consecutive time points. The subject's core temperature was measured using an ingestible temperature monitoring capsule and associated data recorder.|0-3 hours|||degrees Celsius||Standard Deviation|Mean
752345|NCT00564629|Secondary|The Percentage of Subjects With Temperature < 38 ºC and < 38.5 ºC at Any Timepoint During the Time From T0 to T360 Minutes|This outcome measures what percentage of total subjects had a temperature < 38 ºC and < 38.5 ºC at any timepoint during the time from T0 to T360 minutes.|T0 to T360 minutes|Analysis performed on mITT population.||percentage of participants|||Number
752346|NCT00564629|Secondary|Subject's Global Evaluation of Study Medication at T360 Minutes|"This outcome measures how satisfied the subject was with the study treatment. The subject was asked to answer Overall, how would you rate study treatments? at T360 minutes using a 4-point categorical scale (0=poor, 1=fair, 2=good, 3=excellent)."|T360 minutes|Analysis performed on the mITT population.||participants|||Number
752347|NCT00564629|Secondary|Maximum Temperature Reduction Observed From T0 to T360 Minutes|This outcome measures the maximum core temperature reduction observed from T0 to T360 minutes. The subject's core temperature was measured using an ingestible temperature monitoring capsule and associated data recorder.|T0-T360 minutes|Analysis performed on the mITT population.||Degrees Celsius||Standard Deviation|Mean
752348|NCT00564629|Secondary|Time to a Reduction in Temperature From T0 to T360 Minutes.|This outcome measures how much time it took to observe a decrease in subjects' core body temperature by 0.8 ºC, 1.0 ºC, and 1.5 ºC from the temperature at T0 and from the temperature at the peak after T0 through T360 (6 hours). The subject's core temperature was measured using an ingestible temperature monitoring capsule and associated data recorder.|6 hours|Analysis was performed on the mITT population.||Hours||Standard Deviation|Mean
752349|NCT00564629|Primary|The Rapidity of Onset of Antipyretic Effect at 2 Hours (Measured as Weighted Sum of Temperature Differences Over 2 Hours, WSTD2)|This outcome measures when the antipyretic effect begins by statistical analysis of WSTD2, which is the weighted sum of temperature differences from the subject's core temperature at each assessment time point through the first 2 hours compared with the subject's core temperature at T0, weighted by the time elapsed between each 2 consecutive time points. The subject's core temperature was measured using an ingestible temperature monitoring capsule and associated data recorder.|0-2 hours|mITT population defined as all randomized subjects who received at least 1 full dose of oral study medication (subject not vomiting within 2 hours after oral study drug) or 1 full dose of IV study medication(subject having received all 100 mls solution). This analysis was performed with imputation for non-physiological temperature swing zone effect||Degrees Celsius||Standard Deviation|Mean
752350|NCT00567840|Secondary|EBA Expressed as the Change in Time to Positive (TTP) Signal in Liquid Culture for M. Tuberculosis (Days 2-14) Show Description: [Not Specified]||Day 2 and Day 14|||hours/day||Standard Deviation|Mean
752351|NCT00567840|Secondary|EBA Expressed as the Change in Time to Positive (TTP) Signal in Liquid Culture for M. Tuberculosis (Days 0-2)||Day 0 and Day 2|||hours/day||Standard Deviation|Mean
752353|NCT00567840|Secondary|Early Bactericidal Activity (EBA) Measured as the Daily Rate of Change in log10 CFUs (Colony Forming Units) of M. Tuberculosis in Sputum on Solid Media (Days 2-14).||Day 2 and Day 14|Some of the EBA values could not be calculated due to missing results. The number of participants given are the number of participants for whom the results were available for this time period and therefore for whom the relevant EBA could be calculated.||log10 CFU/ml||Standard Deviation|Mean
752354|NCT00567840|Secondary|Early Bactericidal Activity (EBA) Measured as the Daily Rate of Change in log10 CFUs (Colony Forming Units) of M. Tuberculosis in Sputum on Solid Media (Days 0-2).||Day 0 and Day 2|Some of the EBA values could not be calculated due to missing results. The number of participants given are the number of participants for whom the results were available for this time period and therefore for whom the relevant EBA could be calculated.||log10 CFU/ml||Standard Deviation|Mean
752355|NCT00567840|Primary|Early Bactericidal Activity (EBA) Measured as the Daily Rate of Change in log10 CFUs (Colony Forming Units) of M. Tuberculosis in Sputum on Solid Media (Days 0-14).||Day 0 and Day 14|Some of the EBA values could not be calculated due to missing results. The number of participants given are the number of participants for whom the results were available for this time period and therefore for whom the relevant EBA could be calculated.||log10 CFU/ml||Standard Deviation|Mean
752356|NCT00567879|Secondary|Number of Participants With Best Overall Response|Tumors were assessed according to Response Evaluation Criteria in Solid tumors (RECIST). Complete response (CR): disappearance of all lesions (i.e. all evidence of disease, not just the target lesions) determined by 2 observations not less than 4 weeks apart; Partial response (PR): > 30% decrease in the sum of longest diameters of target lesions compared to baseline, with response or stable disease observed in non-target lesions, and no new lesions; Stable disease (SD): neither sufficient shrinkage to qualify for response or sufficient increase to qualify for progressive disease in target lesions, with response or stable disease observed in non-target lesions, and no new lesions; Progressive disease (PD): > 20% increase in the sum of longest diameters of target lesions compared to smallest sum longest diameter recorded. In addition, the sum must also demonstrate an absolute increase of at least 5mm.|day 21|The full analysis set was analyzed. The full analysis set included all randomized participants.||Participants|||Number
752357|NCT00567879|Primary|Number of Participants With Dose Limiting Toxicities (DLTs)|Safety data was reviewed to determine the DLTs. DLTs comprised adverse events (AEs) or abnormal laboratory values that occurred at any time and were assessed as clinically relevant and meeting any of the following criteria: considered to be related to the study treatment and unrelated to disease, disease progression, inter-current illness, or concomitant medications. Toxicities were assessed using the National Cancer Institute common terminology criteria for adverse events (NCI CTCAE), version 3.0. Disease related symptoms were not considered a DLT.|day 21|The Maximum Tolerated Dose (MTD) determining set was used for this analysis. The MTD determining set consisted of all participants who either received sufficient study drug and had sufficient safety evaluations or discontinued due to unacceptable toxicity.||Participants|||Number
752358|NCT00567892|Secondary|Perceived Global Impression of Change (PGIC: Number of Participants With Perceived Global Impression of Change (PGIC) of 1 or Greater|"PGIC is a 7 point scale ranging from -3 to +3,with 0 meaning no change,negative values reporting worsening of symptoms(Tinnitus), and values of +1 or above reporting perceived improvement of Tinnitus.
PGIC score post active rTMS treatment treatment will provide subject's impression of change in tinnitue due to active treatment.PGIC score post rTMS sham will provide subject's impression of change in tinnitus due to sham. Number of subjects with scores of 1 or above are recorded to perceive improvement due to treatment of the corresponding study arm."|End of each treatment period (2 or 4 weeks)|Study participant that successfully completed both study parts active rTMS treatment and sham rTMS treatment were included in analysis.||participants|||Number
752359|NCT00567892|Primary|Change in THI (Tinnitus Handicap Inventory)|Tinnitus Handicap Inventory (THI) is a measure of bother from tinnitus. THI is measured as a score in a scale ranging from 0=No bother to 100=Extremely Bothered. THI score post active rTMS treatment minus THI score pre active rTMS treatment will provide the change in THI score due to active treatment. THI score post rTMS sham minus THI score pre rTMS sham will provide change in THI due to sham. The difference of THI change due to active treatment minus THI change due to sham will provide the THI change that is our primary outcome measure.|baseline at the start of each treatment period, end of each treatment period (2 or 4 weeks)|Study participant that successfully completed both study parts active rTMS treatment and sham rTMS treatment were included in analysis.||units on a scale||95% Confidence Interval|Median
752360|NCT00567996|Secondary|"Percentage of COPD Days of Poor Control During 26 Weeks of Treatment"|"Participants rated their symptoms on a scale of 0=none to 3=severe. A Chronic Obstructive Pulmonary Disease (COPD) day of poor control was defined as any day in the participants diary with a score >=2 (moderate or severe) for at least 2 of 5 symptoms (cough, wheeze, production of sputum, color of sputum, breathlessness). The mixed model used baseline percentage of “days of poor control”, FEV1 prior to and 30 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and one hour post inhalation of ipratropium as covariates."|Up to 26 weeks|Intent-to-treat population included all randomized participants who received at least one dose of study medication. The endpoint was analyzed only for those participants who had data for this outcome measure.||Percentage of days||Standard Error|Least Squares Mean
752361|NCT00567996|Secondary|St. George's Respiratory Questionnaire (SGRQ) Total Score After 12 Weeks of Treatment|SGRQ is a health related quality of life questionnaire consisting of 76 items in three sections: symptoms, activity and impacts. The total score is 0 to 100 with a higher score indicating poorer health status. The mixed model used baseline SGRQ total score, FEV1 prior to and 30 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and one hour post inhalation of ipratropium as covariates.|Week 12|Intent-to-treat population included all randomized participants who received at least one dose of study medication. The endpoint was analyzed only for those participants who had SGRQ data at week 12. Missing data were imputed using Last Observation carried Forward (LOCF).||Score on a scale||Standard Error|Least Squares Mean
752407|NCT00568451|Secondary|Duration of Response for All Evaluable Patients Who Have Achieved an Objective Response|Duration of response was defined as the date at which the participant's objective status was first noted to be either a Complete Response or Partial Response to the date the progression was documented.|up to 2 years|Two complete tumor responses were documented. Both participants have since discontinued the study drug after 35 and 24 cycles respectively, and remain disease-free at 39 and 31.5 months since study entry. There is not enough participants to perform this analysis.|||||
752362|NCT00567996|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) After 12 Weeks of Treatment|Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 hour 10 minute and 23 hour 45 minute post-dose FEV1 readings. Mixed model used baseline FEV1, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and 1 hour post inhalation of ipratropium as covariates.|Week 12|Intent-to-treat population included all randomized participants who received at least one dose of study medication. The end point was analyzed only for those participants who had Trough FEV1 data at week 12. Missing data were imputed using Last Observation carried Forward (LOCF).||Liters||Standard Error|Least Squares Mean
752363|NCT00568022|Primary|Participants Achieving the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)|The MTD was defined as the highest dose evaluated for which less than 1/3 of the participants experienced DLT during the first two treatment cycles. If toxicities (e.g. hand-foot syndrome, existing peripheral neuropathy, etc.) occurred or became more severe in later cycles, the recommended Phase II dose was to be determined after due consideration of their severity.|At the end of Cycle 2 (Day 42)|All participants treated at the highest dose level.||Participants|||Number
752364|NCT00568022|Secondary|Mean Ixabepilone Total Body Clearance (CLT) in One Dosing Interval|CLT = total body clearance as determined from participant serum samples in one dosing interval.|During Cycle 1 at specified timepoints (Day 1 to Day 8).|All participants who received ixabepilone and capecitabine and who had adequate PK concentration profiles.||L/h||Standard Deviation|Mean
752365|NCT00568022|Secondary|Mean Ixabepilone Volume of Distribution at Steady State (Vss) in One Dosing Interval|Vss = volume of distribution at steady state determined from participant serum samples from one dosing interval.|During Cycle 1 at specified timepoints (Day 1 to Day 8).|All participants who received ixabepilone and capecitabine and who had adequate PK concentration profiles.||Liters||Standard Deviation|Mean
752366|NCT00568022|Secondary|Mean Ixabepilone Terminal Elimination Half Life (T 1/2) in One Dosing Interval|T 1/2 = terminal elimination half life as determined from participant serum samples in one dosing interval.|During Cycle 1 at specified timepoints (Day 1 to Day 8).|All participants who received ixabepilone and capecitabine and who had adequate PK concentration profiles.||Hours||Standard Deviation|Mean
752367|NCT00568022|Secondary|Mean Ixabepilone Area Under the Concentration Curve (AUC INF) in One Dosing Interval|AUC = the average area under the concentration curve (AUC [INF]) of ixabepilone as determined from participant serum samples in one dosing interval over 24 hours.|During Cycle 1 at specified timepoints (Day 1 to Day 8).|All participants who received ixabepilone and capecitabine and who had adequate PK concentration profiles.||ng·h/mL||Geometric Coefficient of Variation|Geometric Mean
752368|NCT00568022|Secondary|Mean Ixabepilone Maximum Plasma Concentration (Cmax) in One Dosing Interval|Cmax = maximum observed plasma concentration of ixabepilone as determined from participant serum samples in one dosing interval.|During Cycle 1 at specified timepoints (Day 1 to Day 8).|All participants who received ixabepilone and capecitabine and who had adequate PK concentration profiles.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
752369|NCT00568022|Secondary|Participant Tumor Response at Study Endpoint|Tumor response was assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) in which complete response (CR) = disappearance of all target lesions; partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions; progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions; and stable disease (SD) = small changes that do not meet above criteria.|At baseline and after every 42 days (every 2 21-day cycles) after baseline|All treated participants with measurable disease and tumor response.||Participants|||Number
752370|NCT00568022|Secondary|Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE = any new untoward medical occurrence/worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE = any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Treatment-related=Possible, Probable, or Certain relationship to drug|Baseline to Day 42, continuously|All participants who received at least 1 dose of either ixabepilone or capecitabine.||Participants|||Number
752371|NCT00568022|Primary|Participants Experiencing Dose Limiting Toxicity (DLT)|DLT was defined as any ixabepilone and/or capecitabine related events requiring study discontinuation during the first two treatment cycles.|From initiation of drug through last day of Cycle 2 (Day 42)|All participants who received at least 1 dose of either ixabepilone or capecitabine.||Participants|||Number
752372|NCT00568061|Secondary|Change in Adverse Remodeling Parameters Compared With 48-72 Hrs: Changes in LV End-diastolic Vol, End-systolic Vol, End-diastolic Myocardial Wall Thickness in Infarct, Peri-infarct and Remote Areas, and in Sphericity Index at End-diastole and End-systole||4 months||||||
752373|NCT00568061|Secondary|Troponin T Levels and CPK-MB Area Under the Curve||48 hours||||||
752374|NCT00568061|Secondary|Resolution of ST Segment Elevation Compared With That Observed at Enrollment||4 hours||||||
752375|NCT00568061|Secondary|MI Size as a Fraction of LV Size||4 months||||||
752376|NCT00568061|Secondary|Change in Global LV Function and Mass||between 48-72 hours and 4 months||||||
752377|NCT00568061|Secondary|Global & Regional LV Function and LV Mass||48-72 hours and 4 months||||||
752378|NCT00568061|Secondary|Infarct Transmurality||48-72 hours and 4 months||||||
752379|NCT00568061|Secondary|Myocardial Perfusion at Coronary Angiography||at completion of PCI||||||
752380|NCT00568061|Secondary|MI Size Normalized to Area at Risk||48-72 hours||||||
752381|NCT00568061|Secondary|MI Size at 48-72 Hours||48-72 hours||||||
752382|NCT00568061|Primary|Mean Percent of Myocardial Infarction Size to the Fraction of Left Ventricular Size|The primary endpoint - mean percent of the myocardial infarction size to the fraction of left ventricular size at 48-72 hours was measured by contrast-enhanced cardiac Magnetic Resonance Imaging (MRI).|48-72 hours|Analysis was per intent to treat population||percent of myocardial infarction size||Standard Deviation|Mean
752408|NCT00568451|Secondary|Survival Time|Survival time was defined as the time from registration to death due to any cause.|up to 2 years|||Months||95% Confidence Interval|Median
752622|NCT00561600|Secondary|Analysis of Metal Ion Release - Serum Cobalt|Serum Cobalt|48 months|Metal ion sub-study was limited to two sites. All participants with available data are presented below.||ug/L||Full Range|Median
752383|NCT00568087|Secondary|Alcohol Craving (Obsessive Compulsive Drinking Scale)|"Alcohol craving was secondary a priori outcome measure. Alcohol craving was measured at each weekly visit during the 8 weeks--from week 1 (before starting intervention) to week 9 (after completing intervention).
The Obsessive Compulsive Drinking Scale (OCDS) is a self-rated scale designed to assess alcohol craving. The score range of the OCDS is between 0 and 56, with 56 assigned to the highest (worst) alcohol craving."|Alcohol craving (Obsessive Compulsive Drinking Scale) was measured at each weekly visit during the 8 weeks.|||units on a scale||Standard Error|Mean
752384|NCT00568087|Secondary|Alcohol Craving (Penn Alcohol Craving Scale)|"Alcohol craving was secondary a priori outcome measure. Alcohol craving was measured at each weekly visit during the 8 weeks--from week 1 (before starting intervention) to week 9 (after completing intervention).
The Penn Alcohol Craving Scale (PACS) is a self-rated scale designed to assess alcohol craving. The score range of the PACS is between 0 and 30, with 30 assigned to the highest (worst) alcohol craving."|Alcohol craving (Penn Alcohol Craving Scale) was measured at each weekly visit during the 8 weeks.|||units on a scale||Standard Error|Mean
752385|NCT00568087|Secondary|Liver Function Tests||8 weeks||||||
752386|NCT00568087|Primary|Alcohol Consumption (Percentage of Heavy Drinking Days)|The percentage of heavy drinking days was primary a priori outcome measure. Heavy drinking was defined as ≥ 5 standard drinks per day for men and ≥ 4 standard drinks for women. One standard drink is any drink containing about 0.6 fluid ounces or 14 grams of pure alcohol. The percentage of heavy drinking days (HDD) was measured at each weekly visit during the 8 weeks--from week 1 (before starting intervention) to week 9 (after completing intervention). At each week, the percentage of HDD was calculated during the period (usually 7 days) since the last previous visit.|The percentage of heavy drinking days (HDD) was measured at each weekly visit during the 8 weeks.|All 44 subjects who received intervention were included in analysis.||percentage of heavy drinking days||Standard Error|Mean
752392|NCT00568334|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that results in death, are life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject.|From Day 0 up to study end (Day 86-114)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.||Participants|||Count of Participants
752393|NCT00568334|Secondary|Number of Subjects With Any Unsolicited Adverse Event (AE)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.|Within the 43-day (Days 0-42) post-vaccination period following each dose|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.||Participants|||Count of Participants
752394|NCT00568334|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fever [defined as axillary fever ≥ 37.5 degrees Celsius (°C)] and generalized rash. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 fever = temperature above (>) 39.0°C after vaccination. Grade 3 rash = more than (>) 150 lesions. Related = considered by the investigator to be causally related to the study vaccination.|During the 43-day (Days 0-42) post-vaccination period following each dose|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had the symptoms sheet filled in.||Participants|||Count of Participants
757541|NCT00608569|Secondary|CD4 Count at Follow-up Visits|CD4 cell count (median, inter-quartile range)|At Weeks 4, 12, 24, 36, and 48|||cells/mm3||Inter-Quartile Range|Median
752395|NCT00568334|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.|During the 4-day (Days 0-3) post-vaccination period following each dose|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had the symptoms sheet filled in.||Participants|||Count of Participants
752396|NCT00568334|Secondary|Antibody Concentrations Against Varicella Zoster Virus (VZV)|Antibody concentrations have been assessed by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL), for initially seronegative subjects [with anti-VZV concentration below (<) 25 mIU/mL].|At 86-114 days after the second vaccine dose (Week 12)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all eligible subjects who were seronegative for varicella antibodies at baseline and for whom pre-vaccination and post-vaccination serology results were available.||mIU/mL||95% Confidence Interval|Geometric Mean
752397|NCT00568334|Secondary|Antibody Titers Against Varicella Zoster Virus (VZV)|Antibody titers have been assessed by immunofluorescence assay (IFA) and presented as geometric mean titers (GMTs), for initially seronegative subjects [with anti-VZV titer below (<) 1:4].|At 86-114 days after the second vaccine dose (Week 12)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all eligible subjects who were seronegative for varicella antibodies at baseline and for whom pre-vaccination and post-vaccination serology results were available.||Titers||95% Confidence Interval|Geometric Mean
752398|NCT00568334|Secondary|Number of Subjects With Anti-VZV Antibody Concentrations Above Cut-off Values|Anti-VZV antibody concentrations greater than or equal to (≥) the assay cut-off values of: 25 mIU/mL, 50 mIU/mL and 75 mIU/mL have been assesssed by ELISA, in the sera of subjects who were seronegative before vaccination.|At 43-57 days post-Dose 1 (Week 6) and 86-114 days post-Dose 2 (Week 12)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all eligible subjects who were seronegative for varicella antibodies at baseline and for whom pre-vaccination and post-vaccination serology results were available.||Participants|||Count of Participants
752399|NCT00568334|Secondary|Number of Seroconverted Subjects for Varicella Antibodies|Seroconversion/seroresponse (considering the IFA data) was defined as the appearance of anti-VZV antibodies [i.e. titer/concentration greater than or equal to (≥) the assay cut-off value of 1:4] in the sera of subjects who were seronegative before vaccination.|At 43-57 days post-Dose 1 (Week 6) and 86-114 days post-Dose 2 (Week 12)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all eligible subjects who were seronegative for varicella antibodies at baseline and for whom pre-vaccination and post-vaccination serology results were available.||Participants|||Count of Participants
752400|NCT00568334|Primary|Antibody Concentrations Against Varicella Zoster Virus (VZV)|Antibody concentrations have been assessed by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL), for initially seronegative subjects [with anti-VZV concentration below (<) 25 mIU/mL].|At 43-57 days after the first vaccine dose (Week 6)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all eligible subjects who were seronegative for varicella antibodies at baseline and for whom pre-vaccination and post-vaccination serology results were available.||mIU/mL||95% Confidence Interval|Geometric Mean
752401|NCT00568334|Primary|Antibody Titers Against Varicella Zoster Virus (VZV)|Antibody titers have been assessed by immunofluorescence assay (IFA) and presented as geometric mean titers (GMTs), for initially seronegative subjects [with anti-VZV titer below (<) 1:4].|At 43-57 days after the first vaccine dose (Week 6)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all eligible subjects who were seronegative for varicella antibodies at baseline and for whom pre-vaccination and post-vaccination serology results were available.||Titers||95% Confidence Interval|Geometric Mean
752402|NCT00568386|Primary|Visual Blur|Visual blur profile is a visual scale ranging from 0 (no blur) to 50 (most blurry). Patients were asked to rate there vision on a specific focal point (an object in the room) through 3 minutes.|3 minutes post dose|||Units on a scale||Full Range|Mean
752403|NCT00568399|Primary|Change in Annualized Coronary Calcium Volume Score After Treatment With Sodium Thiosulfate.|We will compare the annualized coronary calcium volume score obtained at the baseline CT of the coronary arteries with another CT obtained of the same coronary arteries following 5 months of sodium thiosulfate treatment.|5 months|This is a feasibility study and all eligible participants were invited to participate. Out of the 48 participates that started, but only 22 completed.||mm3/year||Standard Deviation|Geometric Mean
752404|NCT00568451|Secondary|Number of Participants Who Experienced Changes in Immunologic Profile (IFNγ Producing Peptide Specific CTLs) Within a Treatment|For each patient, a time series plot of the number of IFNγ producing peptide specific CTLs will be constructed. The resulting plots will be visually inspected for trends within and between treatments. A point and an interval estimate of the number of participants (receiving a given treatment) who had at least a 2-fold increase in the number of the number of IFNγ producing peptide specific CTLs will be constructed using the properties of the binomial distribution.|up to 2 years|There is not enough participants to perform this analysis.|||||
752405|NCT00568451|Secondary|Number of Participants Who Experienced Changes in Immunologic Profile (MART-1, Tyrosinase, and gp100) Within a Treatment|For those patients who are HLA-A2+, the maximum post-treatment levels of MART-1, tyrosinase, and gp100 will be determined. For each of these specific melanoma specific antigens, the number of participants (within a given treatment) who gained or maintained immunity based on the maximum post-treatment level of that specific melanoma specific antigen will be determined.|up to 2 years|There is not enough participants to perform this analysis.|||||
752406|NCT00568451|Secondary|Number of Participants Who Experienced Changes in Immunologic Profile (CD4/CD25+ Cells, CD4/Fox-p3+ T Cells) Within a Treatment|Time series plot of the number of circulating cells will be constructed. The resulting plots will be visually inspected for trends within and between treatments. For each cell type, a point and an interval estimate of the number of participants (receiving a given treatment) who had at least a 2-fold increase in the number of circulating cells of that type will be constructed using the properties of the binomial distribution.|up to 2 years|There is not enough participants to perform this analysis.|||||
752409|NCT00568451|Secondary|Time to Disease Progression|Time to disease progression was defined as the time from registration to documentation of disease progression. Disease progression was measured according to the RECIST criteria. Progression: At least a 20 percent increase in the sum of of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|up to 2 years|||Days||95% Confidence Interval|Median
752410|NCT00568451|Primary|Number of Participants With an Objective Tumor Status of Either a Complete Response(CR) or Partial Response (PR), According to RECIST (Response Evaluation Criteria in Solid Tumors) Criteria|"Response that was noted on 2 consecutive evaluations for at least 4 weeks apart.
CR: Disappearance of all target lesions; PR: At least a 30 percent of decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Target lesions: All measurable lesions up to a maximum of 10 lesions representative of all involved organs."|Every other cycle of therapy (cycle=4 weeks) for the first 6 cycles of treatment|All subjects enrolled, met the eligibility criteria who have signed a consent form and have begun their study treatment were evaluable for response.||participants|||Number
752411|NCT00568555|Secondary|Percent Change in Heat Pain Sensitivity Between Baseline and End of Placebo Treatment and Between Baseline to End of LDN Treatment.|A thermode is placed on the palm, and temperature is increased until the first sensation of pain. That temperature is recorded in Degrees Celsius . The procedure is repeated 3 times and results are averaged into a single temperature recording.|Baseline to end of placebo (2 weeks + 4 weeks) and baseline to end of LDN (2 weeks + 12 weeks)|All completers||percentage change from baseline to final||95% Confidence Interval|Mean
752412|NCT00568555|Secondary|Percent Change in Pressure Pain Threshold Between Baseline and End of Placebo Treatment and Between Baseline to End of LDN Treatment.|An algometer is used to apply pressure to 18 points across the body. Pressure is applied until the first sensation of pain in indicated. This pressure is recorded (as kg/cm2) and averaged for all 18 points to provide an overall score.|Baseline to end of placebo (2 weeks + 4 weeks) and baseline to end of LDN (2 weeks + 12 weeks)|All completers||percentage change from baseline to final||95% Confidence Interval|Mean
752413|NCT00568555|Secondary|Percent Change in Fatigue Scores Between Baseline to End of Placebo Treatment and Between Baseline to End of LDN Treatment.|"Visual Analogue Scale for fatigue, 0 to 100, where 0 = no fatigue at all and 100 = severe fatigue.
Baseline fatigue calculated averaging daily scores over the 2 week baseline period.
Placebo and LDN fatigue scores calculated by averaging daily scores during the final 3 days of each condition.
Values were converted to percent change in fatigue: [(baseline fatigue - end point fatigue)/baseline fatigue] x 100."|Baseline to end of placebo (2 weeks + 4 weeks) and baseline to end of LDN (2 weeks + 12 weeks)|All completers||percentage change from baseline||95% Confidence Interval|Mean
752414|NCT00568555|Secondary|Percent Change in Sleep Quality Scores Between Baseline to End of Placebo Treatment and Between Baseline to End of LDN Treatment.|"Visual Analogue Scale for sleep quality, 0 to 100, where 0 = did not sleep well at all and 100 = slept extremely well.
Baseline sleep quality calculated by averaging daily scores over the 2 week baseline period.
Placebo and LDN sleep quality scores calculated by averaging daily scores during the final 3 days of each condition.
Values were converted to percent change in sleep quality: [(baseline sleep - end point sleep)/baseline sleep] x 100."|Baseline to end of placebo (2 weeks + 4 weeks) and baseline to end of LDN (2 weeks + 12 weeks)|All completers||percentage change from baseline||95% Confidence Interval|Mean
752415|NCT00568555|Primary|Percent Change in Pain Scores Between Baseline to End of Placebo Treatment and Between Baseline to End of LDN Treatment.|"Visual Analogue Scale for pain, 0 to 100, where 0=no pain and 100=worst pain imaginable.
Baseline pain calculated averaging daily pain scores over the 2 week baseline period.
Placebo and LDN pain scores calculated by averaging daily pain scores during the final 3 days of each condition.
Values were converted to percent change in pain: [(baseline pain - end point pain)/baseline pain] x 100."|Baseline to end of placebo (2 weeks + 4 weeks) and baseline to end of LDN (2 weeks + 12 weeks)|All completers||percentage change from baseline to final||95% Confidence Interval|Mean
752416|NCT00568685|Secondary|Weight Change From Baseline to Day 42 Endpoint||Baseline, Day 42|ITT population||kilograms (kg)||Standard Deviation|Mean
752417|NCT00568685|Secondary|Blood Pressure Change From Baseline to Day 42 Endpoint||Baseline, Day 42|ITT population||mmHg||Standard Deviation|Mean
752418|NCT00568685|Secondary|Temperature Change From Baseline to Day 42 Endpoint||Baseline, Day 42|ITT population||degrees Celsius||Standard Deviation|Mean
752419|NCT00568685|Secondary|Heart Rate Change From Baseline to Day 42 Endpoint||Baseline, Day 42|ITT population||beats per minute (bpm)||Standard Deviation|Mean
752420|NCT00568685|Secondary|Incidence of Completion of the Columbia Suicide-Severity Rating Scale, Suicide and Self-Harm Summary|Columbia Suicide-Severity Rating Scale (C-SSRS) captures occurrence, severity & frequency of suicide-related thoughts & behaviors, via questions designed to solicit information to determine if a suicide-related thought or behavior occurred. The C-SSRS is not scored; recorded incidents are counted. C-SSRS was only required if an adverse event was reported that the investigator suspected to represent a suicidal thought or behavior. If the C-SSR was completed at a visit, the Self-Harm Supplement was also required. If a self-harm event was reported, the Self-Harm Follow-Up form was also required.|Baseline to Day 42|As treated population||participants|||Number
752421|NCT00568685|Primary|Change From Baseline to Day 42 Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score|Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 none/never or rarely) to 3 (severe/very often). Total scores range from 0 (no symptoms) to 54 (highly symptomatic).|Baseline, Day 42|Analysis included all randomized participants (intent-to-treat population)||units on a scale||95% Confidence Interval|Least Squares Mean
752422|NCT00568685|Secondary|Adverse Events Leading to Discontinuation|Adverse Events (Preferred Term) leading to discontinuation by decreasing frequency|Baseline to Day 42|As-treated population||events|||Number
752423|NCT00568685|Secondary|Change From Baseline in Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Improvement Scale (CGI-ADHD-I) Score at Days 7, 14, 42, and Last Observation Carried Forward Endpoint|Measures total improvement (or worsening) of a patient's ADHD symptoms from the beginning of treatment. (1=very much improved, 7=very much worsened)|Baseline, Days 7, 14, 42|ITT population; LOCF||units on a scale||Standard Deviation|Mean
752424|NCT00568685|Secondary|Change From Baseline in Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale (CGI-ADHD-S) Score at Days 7, 14, 42, and Last Observation Carried Forward Endpoint|Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).|Baseline, Days 7, 14, 42|ITT population; last observation carried forward (LOCF)||units on a scale||Standard Deviation|Mean
752425|NCT00568776|Secondary|Change in Neuropsychiatric Inventory (NPI) Score From Baseline to Week 78 (Full Analysis Set; FAS)|The NPI is used to obtain information on the presence of severity of neuropsychological symptoms, and was specifically designed for use in Alzheimer's disease subjects. The scale consists of 12 items with each item having outcomes from 0 to 12; hence the total score ranges from 0 to 144. Higher scores suggest greater psychiatric impairment.|Baseline and 78 weeks|Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and completed the baseline visit and at least one post-baseline visit.||Scores on a Scale||Standard Error|Mean
752426|NCT00568776|Secondary|Change in Clinical Dementia Rating – Sum of Boxes (CDR-SB) Score From Baseline to Week 78 (Full Analysis Set; FAS)|The CDR-SB consists of 6 items; 3 measuring cognitive ability and 3 measuring functional ability. The score for each of the six items range from 0 to 3; hence the total score is between 0 and 18. Higher scores suggest greater cognitive impairment.|Baseline and 78 weeks|Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and completed the baseline visit and at least one post-baseline visit.||Scores on a Scale||Standard Error|Mean
752427|NCT00568776|Primary|Additional Analysis of Primary Outcome Measure: Change From Baseline to Week 78 in Alzheimer‘s Disease Cooperative Study – Activities of Daily Living (ADCS-ADL) Score (Per Protocol Set; PPS)|The ADCS-ADL is a 23-item scale that measures a subject's functional abilities as assessed by the subject's caregiver. This scale ranges from 0 to 78, with lower scores suggesting greater functional impairment.|Baseline and 78 weeks|Per Protocol Set (PPS): all randomized patients who received at least one dose of ELND005 250 mg or placebo, completed all scheduled visits up to Week 78, were at least 80% compliant with study drug, and met all inclusion/exclusion criteria.||Scores on a Scale||Standard Error|Mean
752428|NCT00568776|Primary|Change From Baseline to Week 78 in Alzheimer‘s Disease Cooperative Study – Activities of Daily Living (ADCS-ADL) Score (Full Analysis Set; FAS)|The ADCS-ADL is a 23-item scale that measures a subject's functional abilities as assessed by the subject's caregiver. This scale ranges from 0 to 78, with lower scores suggesting greater functional impairment.|Baseline and 78 weeks|Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and completed the baseline visit and at least one post-baseline visit.||Scores on a Scale||Standard Error|Mean
752429|NCT00568776|Primary|Additional Analysis of Primary Outcome Measure: Change From Baseline to Week 78 in Neuropsychological Test Battery (NTB) Z-score (Per Protocol Set; PPS)|The NTB assessment is comprised of 9 instruments that measure cognition and executive function. Three of these tests measure immediate memory, next three measure delayed memory, and remaining three assess executive function. The total score is a weighted mean of the nine tests, referred to as the Z-score. Typically, scores range from -3 and 3, with lower scores suggesting greater cognitive impairment.|Baseline and 78 weeks|Per Protocol Set (PPS): all randomized patients who received at least one dose of ELND005 250 mg or placebo, completed all scheduled visits up to Week 78, were at least 80% compliant with study drug, and met all inclusion/exclusion criteria.||Scores on a Scale||Standard Error|Mean
752430|NCT00568776|Secondary|Change in Alzheimer‘s Disease Assessment Scale – Cognitive Subscale (ADAS-Cog) Score From Baseline to Week 78 (Full Analysis Set; FAS)|The ADAS-Cog primarily measures cognitive ability. The version used in this study was comprised of 12 items with scores ranging from 0 to 75. Higher scores suggest greater cognitive impairment.|Baseline and 78 weeks|Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and completed the baseline visit and at least one post-baseline visit.||Scores on a Scale||Standard Error|Mean
752431|NCT00568776|Primary|Change From Baseline to Week 78 in Neuropsychological Test Battery (NTB) Z-score (Full Analysis Set; FAS)|The NTB assessment is comprised of 9 instruments that measure cognition and executive function. Three of these tests measure immediate memory, next three measure delayed memory, and remaining three assess executive function. The total score is a weighted mean of the nine tests, referred to as the Z-score. Typically, scores range from -3 and 3, with lower scores suggesting greater cognitive impairment.|Baseline and 78 weeks|Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and completed the baseline visit and at least one post-baseline visit.||Scores on a Scale||Standard Error|Mean
752432|NCT00568854|Primary|Kinetics of Mycobacterial-specific Immune Response After BCG Vaccination|Blood was sampled at times 0, 2, 4, 6, 8, 12, 16, and 20 weeks post BCG vaccination and Interferon gamma production was measured as change from pre-vaccination baseline. Timeline of peak IFn-g response was measured for both study groups.|5 months|||weeks when peak response was observed||Standard Deviation|Mean
752433|NCT00568854|Primary|Antigen-specific Immune Response Measured by Reaction to Tuberculin Skin Test|Participants had baseline tuberculin testing (TST), followed by BCG vaccination, and at 5 months after vaccination, study participants had repeat tuberculin skin testing done.|5 months|||mm||Full Range|Median
752434|NCT00568958|Primary|Percent Days Abstinent From Drinking|Self-reported drinking was primarily obtained through diary data, with the Timeline Follow-Back Interview (TLFB) used to replace missing data at baseline and at each biweekly visit over the 8-weeks.The eight weeks follow-up measure is summarized across all biweekly visits.|8 Weeks|||% days abstinent||Standard Deviation|Mean
752435|NCT00568958|Primary|Percent Days Abstinent From Drinking|Self-reported drinking was primarily obtained through diary data, with the Timeline Follow-Back Interview (TLFB) used to replace missing data at baseline and at each biweekly visit over the 8-weeks.The eight weeks follow-up measure is summarized across all biweekly visits. Baseline measures captured the prior 4 weeks.|Baseline|||% days abstinent||Standard Deviation|Mean
752436|NCT00568958|Secondary|Percentage of Drinking to an Estimated Blood Alcohol Concentration (BAC) of .08 or Higher|"Self-reported drinking was primarily obtained through diary data, with the Timeline Follow-Back Interview (TLFB) used to replace missing data at baseline and at each biweekly visit over the 8-weeks.The eight weeks follow-up measure is summarized across all biweekly visits.
BAL (Blood Alcohol Level) was estimated using data from the daily diaries based on the number of drinks consumed, the duration of drinking, and total body water (based on gender, age, height and weight) using Curtin’s formula."|8 weeks|||percentage of days||Standard Deviation|Mean
752438|NCT00568958|Primary|Frequency of Heavy Episodic Drinking|"Self-reported drinking was primarily obtained through diary data, with the Timeline Follow-Back Interview (TLFB) used to replace missing data at baseline and at each biweekly visit over the 8-weeks.The eight weeks follow-up measure is summarized across all biweekly visits.
Frequency of heavy episodic drinking is measured as 5 or more drinks in a day for males, and 4 or more drinks in a day for females over an eight week period. A standard drink was equivalent to 0.6 gm of absolute alcohol (e.g., 12-oz beer, 5-oz wine, or 1.5-oz, 80-proof liquor)."|eight weeks|||percentage of heavy drinking days||Standard Deviation|Mean
752439|NCT00568958|Secondary|Number of Drinks Per Drinking Day|Self-reported drinking was primarily obtained through diary data, with the Timeline Follow-Back Interview (TLFB) used to replace missing data at baseline and at each biweekly visit over the 8-weeks.The eight weeks follow-up measure is summarized across all biweekly visits. Baseline measures captured the prior 4 weeks.|Baseline|||drinks per drinking day||Standard Deviation|Mean
752440|NCT00568958|Primary|Frequency of Heavy Episodic Drinking|Self-reported drinking was primarily obtained through diary data, with the Timeline Follow-Back Interview (TLFB) used to replace missing data at baseline and at each biweekly visit over the 8-weeks.The eight weeks follow-up measure is summarized across all biweekly visits. Frequency of heavy episodic drinking is measured as 5 or more drinks in a day for males, and 4 or more drinks in a day for females. A standard drink was equivalent to 0.6 gm of absolute alcohol (e.g., 12-oz beer, 5-oz wine, or 1.5-oz, 80-proof liquor). Baseline measures captured the prior 4 weeks.|Baseline|||percentage of heavy drinking days||Standard Deviation|Mean
752441|NCT00569010|Primary|Number of Participants With Complete Remission|Clinical response is determined by achievement of a complete remission (CR) as judged by morphological criteria (< 1% blasts in bone marrow with neutrophil recovery) according to International Working Group (IWG) criteria.|6 weeks|Analysis was per protocol.||participants|||Number
752442|NCT00569127|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Up to 3 years|Eligible patients who received any treatment and were assessed for adverse events are included in this summary. Eleven patients did not start protocol treatment due to: patient refusal (6), financial reasons (3), and worsening condition/progression (2). None were assessable for adverse events and thus are not included in this analysis.||Participants|||Number
752443|NCT00569127|Secondary|Objective Response (Confirmed and Unconfirmed Complete Response and Partial Response)|Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0): Complete Response (CR) is disappearance of all measurable and non-measurable disease, and no new lesions; Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions, no unequivocal progression of non-measurable disease, and no new lesions. Confirmed response is two or more objective statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration. Partial response is two or more objective statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration. Unconfirmed CR is one objective status of CR documented before progression or symptomatic deterioration but not qualifying as CR or PR. Unconfirmed PR is one objective status of PR documented before progression or symptomatic deterioration but not qualifying as CR, PR or unconfirmed CR.|Up to 3 years|All eligible patients with measurable disease will be included in this analysis according to the randomized treatment assignment.||participants|||Number
752444|NCT00569127|Secondary|Local Progression-Free Survival (Investigator Assessed)|From date of randomization (which is the date of registration) to date of first documentation of progression [per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) as defined in Section 10.2d] or symptomatic deterioration (as defined in Section 10.2e), or death due to any cause. Patients last known not to have progressed are censored at date of last contact. Progression (Section 10.2d) includes one or more of the following: 20% increase in the sum of the longest diameters of target measurable lesions over smallest sum observed using the same techniques as baseline; unequivocal progression of non-measurable disease in the opinion of the treating physician; appearance of new lesion/site; or death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration (Section 10.2e) is global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.|Up to 3 years|According to the intent-to-treat principle, all eligible patients will be included in this analysis according to the randomized treatment assignment, regardless of actual treatments received.||months||95% Confidence Interval|Median
752445|NCT00569127|Secondary|Time to Treatment Failure|From date of randomization (which is the date of registration) to date of first observation of progressive disease (as defined in Section 10.2d), death due to any cause, symptomatic deterioration (as defined in Section 10.2e), or discontinuation of treatment. This has been calculated using Central-Review based progression events. Patients last known not to have failed treatment are censored at date last known not to have failed. Patients with incomplete Central Radiological Review are censored at the date of last Central Radiological Review if patient has not failed treatment prior to that time.|Up to 3 years|According to the intent-to-treat principle, all eligible patients will be included in this analysis according to the randomized treatment assignment, regardless of actual treatments received.||months||95% Confidence Interval|Median
752446|NCT00569127|Primary|Central Review-based Progression-Free Survival|From date of randomization (which is the date of registration) to date of first documentation of progression based on Central Radiological Review of the appropriate CT or MRI scans, or symptomatic deterioration (as defined in Section 10.2e)), or development of new lesions or disease not identified on CT or MRI, or death due to any cause. Patients who have a local assessment of progression based on imaging, but for whom central review does not concur, will be censored at the last Central Radiological Review date, unless subsequent scans or documentation of symptomatic deterioration provides evidence of progression. Patients last known not to have progressed are censored at the date of last contact. Patients with incomplete Central Radiological Review are censored at the date of last Central Radiological Review if patient has not progressed prior to that time.|Up to 3 years|According to the intent-to-treat principle, all eligible patients will be included in this analysis according to the randomized treatment assignment, regardless of actual treatments received.||months||95% Confidence Interval|Median
752623|NCT00561600|Secondary|Analysis of Metal Ion Release - Erythrocyte Chromium|Erythrocyte chromium|36 months|Metal ion sub-study was limited to two sites. All participants with available data are presented below.||ug/L||Full Range|Median
752447|NCT00569127|Secondary|Overall Survival|From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Up to 7 years|According to the intent-to-treat principle, all eligible patients will be included in this analysis according to the randomized treatment assignment, regardless of actual treatments received.||months||95% Confidence Interval|Median
752448|NCT00569166|Secondary|Pearson Correlation Coefficients for Changes in Hot Flash Scores From Baseline to Week 9 With Changes in Symptom Experience Diary From Baseline to Week 9|Symptom Experience Diary is a self-report diary of expected side effects from controlled breathing on 10-points scale with 10 represents symptoms all the time. Individual item scores were then transformed into 0 to 100 scale, with 100 indicates best quality of life (QOL). Change from baseline to week 9 was calculated by subtracting the baseline scores from the scores at week 9. The correlation was estimated using Pearson correlation coefficients. The assessment of the Pearson Correlation Coefficients was the pre-specified Secondary outcome, and not the underlying changes in the Symptom Experience Diary item scores.|Baseline and Week 9|Includes all participants who completed both baseline and week 9 assessments.||Correlation coefficient|||Number
752449|NCT00569166|Secondary|Change From Baseline to Week 9 for Symptom Distress Diary|Symptom Experience Diary is a self-report diary of expected side effects from controlled breathing on 10-points scale with 10 represents symptoms all the time. Individual item scores were then transformed into 0 to 100 scale, with 100 indicates best quality of life (QOL). Change from baseline to week 9 was calculated by subtracting the baseline scores from the scores at week 9.|Baseline and Week 9|Includes all participants who completed both baseline and week 9 assessments.||units on a scale||Standard Deviation|Mean
752450|NCT00569166|Secondary|Pearson Correlation Coefficients for Changes in Hot Flash Scores From Baseline to Week 9 With Changes in BFI Fatigue From Baseline to Week 9|Brief Fatigue Inventory (BFI) consist of 3 items that assess the severity of fatigue and 6 items that assess the impact of fatigue on daily functioning in a 10-points scale with 0 as no fatigue or does not interfere with daily functioning and 10 as bad fatigue or completely interferes. The scores for the six items were summed up to form a total interference score. The linear analogue scale of fatigue was a 10-points scale with 0 as no fatigue and 10 as bad fatigue. All scores were then transformed into 0 to 100 scale, with 100 as less fatigue/less interference. Change from baseline to week 9 was calculated by subtracting the baseline scores from the scores at week 9. The correlation was estimated using Pearson correlation coefficients. The assessment of the Pearson Correlation Coefficients was the pre-specified Secondary outcome, and not the underlying changes in the BFI fatigue items scores.|Baseline and Week 9|Includes all participants who completed both baseline and week 9 assessments.||Correlation coefficient|||Number
752451|NCT00569166|Secondary|Change From Baseline to Week 9 for BFI Fatigue Scores|Brief Fatigue Inventory (BFI) consist of 3 items that assess the severity of fatigue and 6 items that assess the impact of fatigue on daily functioning in a 10-points scale with 0 as no fatigue or does not interfere with daily functioning and 10 as bad fatigue or completely interferes. The scores for the six items were summed up to form a total interference score. The linear analogue scale of fatigue was a 10-points scale with 0 as no fatigue and 10 as bad fatigue. All scores were then transformed into 0 to 100 scale, with 100 as less fatigue/less interference. Change from baseline to week 9 was calculated by subtracting the baseline scores from the scores at week 9.|Baseline and Week 9|Includes all participants who completed both baseline and week 9 assessments.||units on a scale||Standard Deviation|Mean
752452|NCT00569166|Secondary|Pearson Correlation Coefficients for Changes in Hot Flash Scores From Baseline to Week 9 With Changes in POMS Total Score and Subscales From Baseline to Week 9|Profile of Mood States (POMS) measures a variety of mood states including tension/anxiety, depression/dejection, anger/hostility, vigor/activity, fatigue/inertia and confusion/bewilderment. Each subscale consist of 5 items with a 5 points-scale (0=not at all, 1=a little, 2=moderately, 3=quite a bit and 4=extremely). The subscale scores were the sum of all five items. The total score was the sum of all subscale scores. The scores were then transformed into a 100-point scale with higher numbers indicating best quality of life (QOL). Change from baseline to week 9 was calculated by subtracting the baseline scores from the scores at week 9. The correlation was estimated using Pearson correlation coefficients. The assessment of the Pearson Correlation Coefficients was the pre-specified Secondary outcome, and not the underlying changes in the POMS scores.|Baseline and Week 9|Includes all participants who completed both baseline and week 9 assessments.||Correlation coefficient|||Number
752453|NCT00569166|Secondary|Change From Baseline to Week 9 for POMS Total Score and Subscales|Profile of Mood States (POMS) measures a variety of mood states including tension/anxiety, depression/dejection, anger/hostility, vigor/activity, fatigue/inertia and confusion/bewilderment. Each subscale consist of 5 items with a 5 points-scale (0=not at all, 1=a little, 2=moderately, 3=quite a bit and 4=extremely). The subscale scores were the sum of all five items. The total score was the sum of all subscale scores. The scores were then transformed into a 100-point scale with higher numbers indicating best quality of life (QOL). Change from baseline to week 9 was calculated by subtracting the baseline scores from the scores at week 9.|Baseline and Week 9|Includes all participants who completed both baseline and week 9 assessments.||units on a scale||Standard Deviation|Mean
752454|NCT00569166|Secondary|Change From Baseline to Week 9 on Blood Pressure Measurement|Participants were taught home monitoring of blood pressure and provided with the sphygmomanometer. The measurements data were recorded on the Blood Pressure Measurement log. Change from baseline to week 9 was calculated by subtracting the baseline measurement from the measurement at week 9.|Baseline and Week 9|Includes all participants who had both baseline and week 9 blood pressure measurements.||mmHg||Full Range|Median
752455|NCT00569166|Secondary|Change From Baseline to Week 9 for PSQI Global Score|The Pittsburgh Sleep Quality Index (PSQI) has 19 items and seven component scales: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep-wake disturbances, use of sleep medication, and daytime dysfunction. The scoring algorithm yields seven component scales on 0-3 scales which are summed to produce a global score on a 0-21 scale with higher values representing more severe sleep difficulty. The global score is translated into 0-100 scale with high values representing best quality of life (QOL). The habitual sleep efficiency component and global score was estimated using the worst-case scenarios for the values that were provided for PSQI question 4. Change from baseline to week 9 was calculated by subtracting the baseline scores from the scores at week 9.|Baseline and Week 9|Includes all participants who completed both baseline and week 9 assessments.||units on a scale||Full Range|Median
752456|NCT00569166|Primary|The Difference in Hot Flash Score (Frequency and Severity) Between Baseline (Week 1) and Week 9|Hot flash severity were graded from 1 to 4, as they range from mild, moderate, severe, or very severe. A hot flash score is defined by multiplying the daily frequency with the average hot flash severity. These scores are aggregated into average weekly hot flash activity scores for each patient.|Week 1 and Week 9|||units on a scale||Standard Deviation|Mean
752457|NCT00569192|Secondary|Change From Baseline in Nighttime Individual Symptom Scores|"The individual symptoms at each time point to be monitored are: cough, wheeze, and shortness of breath.
The individual symptoms were scored using a four point scale:
0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms
Individual nighttime symptom score is defined as an average of the last 5 nights' individual symptom scores within the last 7 nights immediately preceding the end day of that week. A negative change indicates an improvement of symptoms and a positive change indicates a worsening of symptoms."|baseline, week 12|Intent-to-treat includes all randomized patients who have received at least one dose of study drug and have baseline and at least one post treatment efficacy assessment available.||units on a scale||Standard Deviation|Mean
752458|NCT00569192|Secondary|Change From Baseline in Daytime Individual Symptom Scores|"The individual symptoms at each time point to be monitored are: cough, wheeze, and shortness of breath.
The individual symptoms were scored using a four point scale:
0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms
Individual Daytime symptom score is defined as an average of the last 5 days' individual symptom scores within the last 7 days immediately preceding the end day of that week. A negative change indicates an improvement of symptoms and a positive change indicates a worsening of symptoms."|baseline, week 12|Intent-to-treat includes all randomized patients who have received at least one dose of study drug and have baseline and at least one post treatment efficacy assessment available.||units on a scale||Standard Deviation|Mean
752459|NCT00569192|Secondary|Change From Baseline in PEF|The peak expiratory flow (PEF) is the highest air flow achieved from a maximum forced expiratory maneuver measured in liters of air per minute (L/min). Subjects had to perform at least 3 acceptable maneuvers into a PEF meter. An increase indicates an improvement (a greater volume of air expired).|baseline, week 12|The modified-intent-to-treat population includes all randomized patients who were deemed capable of spirometry measurements at baseline and at least at one of the post treatment visits.||L/min||Standard Deviation|Mean
752460|NCT00569192|Primary|Change From Baseline in Nighttime Composite Symptom Score|"The individual symptoms at each time point to be monitored are: cough, wheeze, and shortness of breath.
The individual symptoms were scored using a four point scale:
0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms
Nightly composite symptom score is based on the average of the individual symptom scores for the night. Nightime composite symptom score is defined as average of the last 5 days' nightly composite symptom scores within the last 7 nights immediately preceding the end day of that week. The range for the nighttime composite symptom score is 0 (no symptoms) to 3 (severe symptoms). A negative change indicates an improvement of symptoms and a positive change indicates a worsening of symptoms."|baseline, week 12|Intent-to-treat includes all randomized patients who have received at least one dose of study drug and have baseline and at least one post treatment efficacy assessment available.||units on a scale||Standard Deviation|Mean
752461|NCT00569192|Secondary|Change From Baseline in FEV1% Predicted|The forced expiratory volume in 1 second (FEV1) is the amount forced of air exhaled in 1 second. The percent predicted is calculated for age, gender, and height. Subjects had to perform at least 3 acceptable maneuvers into a spirometer and the largest volume from the 3 maneuvers was selected. An increase indicates an improvement (a greater volume of air expired).|baseline, week 12|The modified-intent-to-treat population includes all randomized patients who were deemed capable of spirometry measurements at baseline and at least at one of the post treatment visits.||percentage of predicted FEV1||Standard Deviation|Mean
752462|NCT00569192|Primary|Change From Baseline in Daytime Composite Symptom Score|"The individual symptoms at each time point to be monitored are: cough, wheeze, and shortness of breath.
The individual symptoms were scored using a four point scale:
0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms
Daily composite symptom score is based on the average of the individual symptom scores for a day. Daytime composite symptom score is defined as average of the last 5 days' daily composite symptom scores within the last 7 days immediately preceding the end day of that week. The range for the daytime composite symptom score is 0 (no symptoms) to 3 (severe symptoms). A negative change indicates an improvement of symptoms and a positive change indicates a worsening of symptoms."|baseline, week 12|Intent-to-treat includes all randomized patients who have received at least one dose of study drug and have baseline and at least one post treatment efficacy assessment available.||units on a scale||Standard Deviation|Mean
752463|NCT00569231|Other Pre-specified|Number of Participants With Immune Response to Human Papillomavirus Type 57 (HPV-57) L1-peptide|Immunologic responses from peripheral blood mononuclear cells collected prior to vaccination and post-vaccination were measured by ex vivo interferon-γ enzyme-linked immunospot (IFN-γ ELISPOT) assay to human papillomavirus type 57 L1-peptide.|Initial visit to completion of protocol, which is up to 30 weeks|The interferon-γ enzyme-linked immunospot assay was performed on available samples from participants who completed the study.||Participants|||Number
752464|NCT00569231|Secondary|Number of Participants With Clinical Resolution of 2nd Anatomically Distant, Non-injected Wart|When the participant completed the protocol, clinical resolution of 2nd anatomically distant, non-injected wart was determined by the overall percentage of resolution from the initial visit.|Initial visit to completion of protocol, which is up to 30 weeks|The participants with 2nd anatomically distant, non-injected wart were analyzed.||Participants|||Number
752465|NCT00569231|Secondary|Number of Participants With Clinical Resolution of 1st Anatomically Distant, Non-injected Wart|When the participant completed the protocol, clinical resolution of 1st anatomically distant, non-injected wart was determined by the overall percentage of resolution from the initial visit.|Initial visit to completion of protocol, which is up to 30 weeks|Participants with 1st anatomically distant, non-injected wart were analyzed.||Participants|||Number
752480|NCT00569270|Primary|Bronchodilator Response: Peak FVC (L) (Forced Vital Capacity)- Tiotropium and Placebo|Lung function studies (mean +/- SD) of peak forced vital capaciy (L) after 30 days (+2h) of tiotropium versus placebo in 29 moderate COPD patients. Forced vital capacity - liters|30 days|Peak FVC after 30 days (+2h) of tiotropium versus placebo in 29 moderate COPD patients.||liters||Standard Deviation|Mean
752466|NCT00569231|Primary|Number of Participants With Clinical Resolution of Injected Wart|When the participant completed the protocol, clinical resolution of the injected wart was determined by the overall percentage of resolution from the initial visit. Participants were classified as 'complete responders' if they had complete resolution of the injected wart, 'partial responders' if the injected wart regressed between 25% and 99%, and 'non-responders' if they had not achieved at least 25% regression of the injected wart.|Initial visit to completion of protocol, which is up to 30 weeks|The participants were analyzed if they completed the protocol by achieving complete resolution of the treated wart, receiving the maximum of 10 treatments, or by having less than 25% resolution of the treated wart after 5 treatments.||Participants|||Number
752467|NCT00569270|Secondary|Extent of Lung CT Scored Emphysema and and Lung Function of FRC/TLC (Functional Residual Capacity(L)/Total Lung Capacity (L) After Tiotropium|Correlation between improved lung function after tiotropium and extent of lung CT scored emphysema with respect to ratio functional residual capacity divided by total lung capacity. Specifically, correlation of tiotropium induced bronchodilation and extent of lung ct scored emphysema|baseline to trough tiotropium|High resolution, thin-section scans of the lung were obtained in a subset of 19 patients.||percentage of lung tissue||Standard Deviation|Mean
752468|NCT00569270|Primary|TLC (L) Before and After Metronome Paced Hyperventilation Induced Dynamic Hyperinflation in Tiotropium Cohort Versus Placebo|Total lung capacity before and after metronome paced hyperventilation induced dynamic hyperinflation in tiotropium cohort versus placebo. Difference between TLC measured at one hour before intervention & 2 hrs. after after 30 days of treatment with either placebo or tiotropium|one hour before intervention & 2 hrs. after after 30 days|lung function studies (mean +/- SE) from baseline to trough (-1h) and peak (+2h) after 30 days of tiotropium versus placebo in 29 moderate COPD patients.||liters||Standard Deviation|Mean
752469|NCT00569270|Primary|IC (Inspiratory Capacity L)and Metronome Paced Hyperventilation-induced Dynamic Hyperinflation in Tiotropium Cohort Versus Placebo and Baseline|IC measurement before and after metronome paced hyperventilation-induced dynamic hyperinflation at baseline and in tiotropium and placebo groups. Measure ratio of functional residual capacity divided by total lung capacity at baseline and after 30 days of tiotropium versus placebo|baseline and 30 days (+2h) post dose|Inspiratory capacity (IC) (mean +/- SD) from baseline and after 30 days of tiotropium versus placebo in 29 moderate COPD patients.||liters||Standard Deviation|Mean
752470|NCT00569270|Primary|Bronchodilator Response: Trough TLC (L) (Total Lung Capacity)- Tiotropium Versus Placebo|Lung function studies Trough TLC(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients|30 days|Lung function studies Trough TLC(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients||liters||Standard Deviation|Mean
752471|NCT00569270|Primary|Bronchodilator Response: Trough FRC/TLC (Functional Residual Capacity/Total Lung Capacity)- Tiotropium Versus Placebo|Lung function studies Trough FRC/TLC(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients Trough Functional residual capacity/total lung capacity - percentage|30 days|Lung function studies Trough FRC/TLC(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients Trough Functional residual capacity/total lung capacity - percentage||percentage of FRC/TLC||Standard Deviation|Mean
752472|NCT00569270|Primary|Bronchodilator Response: Trough IC (L) Inspiratory Capacity - Tiotropium Versus Placebo|Lung function studies (Trough IC(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients Trough inspiratory capacity- liters|30 days|Lung function studies (Trough IC(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients Trough inspiratory capacity- liters||liters||Standard Deviation|Mean
752473|NCT00569270|Primary|Bronchodilator Response: Trough FVC (L)- (Forced Vital Capacity) Tiotropium Versus Placebo|Lung function studies Trough FVC(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients|30 days|Lung function studies Trough FVC(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients||liters||Standard Deviation|Mean
752474|NCT00569270|Primary|Bronchodilator Response: Trough FRC (L)- Tiotropium Versus Placebo|Lung function studies Trough FRC(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients. Functional residual capacity(liters)|30 days|Lung function studies Trough FRC(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients. Functional residual capacity(liters)||liters||Standard Deviation|Mean
752475|NCT00569270|Primary|Bronchodilator Response: Trough FEV1 (L)- (Forced Expiratory Volume) Tiotropium Versus Placebo|Lung function studies Trough FEV1(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients. Forced expiratory volume in 1s (liters)|30 days|Lung function studies Trough FEV1(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients||liters||Standard Deviation|Mean
752476|NCT00569270|Primary|Bronchodilator Response: Peak TLC (L) (Total Lung Capacity)- Tiotropium or Placebo|Net change in lung function studies (mean +/- SE) from baseline to trough (-1h) and peak (+2h) after 30 days of tiotropium versus placebo in 29 moderate COPD patients. Total lung capacity - liters|30 days|Net change in lung function studies (mean +/- SE) from baseline to trough (-1h) and peak (+2h) after 30 days of tiotropium versus placebo in 29 moderate COPD patients.||liters||Standard Deviation|Mean
752477|NCT00569270|Primary|Bronchodilator Response: Peak FRC/TLC Percentage (Functional Residual Capacity(L)/Total Lung Capacity(L) - Tiotropium or Placebo|Lung function studies (mean +/- SD) peak Peak FRC/TLC after 30 days (+2h)of tiotropium versus placebo in 29 moderate COPD patients. Functional residual capacity/total lung capacity - percentage|30 days|Lung function studies (mean +/- SD) peak Peak FRC/TLC after 30 days (+2h)of tiotropium versus placebo in 29 moderate COPD patients. Functional residual capacity/total lung capacity - percentage||percentage of FRC/TLC||Standard Deviation|Mean
752478|NCT00569270|Primary|Bronchodilator Response: Peak IC (L) - (Inspiratory Capacity) - Tiotropium Versus Placebo|Lung function studies (mean +/- SD) - Peak inspiratory capacity after 30 days (+2h)of tiotropium versus placebo in 29 moderate COPD patients. Inspiratory capacity- liters|30 days|Net change in lung function studies (mean +/- SE) from baseline to trough (-1h) and peak (+2h) after 30 days of tiotropium versus placebo in 29 moderate COPD patients.||liters||Standard Deviation|Mean
752479|NCT00569270|Secondary|IC (Inspiratory Capacity, L) Post Mph (Metronome Paced Hyperventilation) Induced dh (Dynamic Hyperinflation) After Tiotropium and Extent of Lung CT Scored Emphysema|Correlation between change in inspiratory capacity (L) post metronome paced hyperventilation induced dynamic hyperinflation and extent of lung ct scored emphysema|baseline to 30 days|Analysis was carried out per protocol||percentage of lung tissue||Standard Deviation|Mean
752482|NCT00569270|Secondary|Extent of Lung CT Scored Emphysema and and Lung Function of FEV1(l) After Tiotropium|Correlation between improved lung function after tiotropium and extent of lung CT scored emphysema with respect to FEV 1; correlation of tiotropium induced bronchodilation and extent of lung ct scored emphysema; measures include increase in FEV1 from baseline to peak tiotropium|baseline to 30 days|High-resolution, thin-section scans of the lung were obtained from a subset of 19 patients.||percentage of lung tissue||Standard Deviation|Mean
752483|NCT00569270|Primary|Bronchodilator Response:Peak FEV1(L)(Forced Expiratory Volume in One Second)-|Lung function studies (mean +/- SD): peak FEV1 (+2h) after 30 days of placebo or tiotropium in 29 moderate COPD patients. FEV1 = Forced expiratory volume in one second|30 days|Lung function studies (mean +/- SD): peak FEV1 (+2h) after 30 days of placebo or tiotropium in 29 moderate COPD patients. FEV1 = Forced expiratory volume in one second||liters||Standard Deviation|Mean
752484|NCT00569374|Secondary|Methamphetamine Withdrawal as Measured Using the Amphetamine Withdrawal Questionaire.|The Amphetamine Withdrawal Questionaire was given at intake and 3 times weekly during the first 3 weeks of the study. This time span was chosen due to the tendency of methamphetamine withdrawal to enter an acute phase in the first week after last use with a subsequent subacute phase following for the next two weeks(McGregor et al, 2005). This questionaire is comprised of 10 items which describe symptoms associated with the cessation of chronic amphetamine use for which participants indicate severity on a 4-point scale. The minimum score is 0 and the maximum score is 40.|Thrice weekly for the first three weeks|The data reported was obtained by computing the overall mean numerical score on the Amphetamine Withdrawal Questionaire for each participant, then using these to compute the overall mean. The scale consists of 13 items ranging from 0 (none) to 4 (worst). The total score ranges from 0 (least) to 52 (worst).||units on a scale||Standard Deviation|Mean
752485|NCT00569374|Primary|Depression as Measured by the Hamilton Depression Scale|Participants were administered the Hamilton Depression Scale thrice weekly throughout the study. The scale is a 21 item questionaire with scores ranging from 0 to 62 with a cutoff for depression of 15.|Thrice weekly for 7 weeks|The data reported was obtained by computing the overall mean score on the Hamilton Depression Scale for each participant, then using these to compute the overall mean. It is a 22 item scale of which 13 items have a score of 0 (none) to 4 (worst) and 9 have a score of 0 (none) to 2 (worst). The total score ranges from 0 (least) to 70 (worst).||units on a scale||Standard Deviation|Mean
752486|NCT00569374|Primary|Anxiety as Measured by the Hamilton Anxiety Scale|Participants were administered the Hamilton Anxiety Scale thrice weekly throughout the study. The scale is a 14 item questionaire with scores ranging from 0 to 56.|Thrice weekly for 7 weeks|The data reported was obtained by computing the overall mean score on the Hamilton Anxiety Scale for each participant, then using these to compute the overall mean. The scale is a 14 item instrument with each item scoring a potential range of 0 (none) to 4 (worst). The potential total scores range form 0 (least) to 56 (worst).||units on a scale||Standard Deviation|Mean
752487|NCT00569374|Primary|"Modafinil Side Effects Checklist"|"Modafinil side effects were measured weekly by means of the Modafinil Side Effects Checklist which asked participants to rate their experience of the following potential side effects: headaches, nausea, nervousness, runny nose, diarrhea, back pain, anxiety, insomnia, dizziness and upset stomach. Participants rated their experience on a 4 point scale ranging from not at all (0) to very much (4). The score was determined by units on a scale."|Weekly for 7 weeks|The data reported was obtainined by computing the overall mean numberical score on the Modafinil Side Effects Checklist for each participant, then using these to compute the overall mean. The checklist is a 10 item scale with each item scoring between 0 (none) to 4 (worst). The potential scores range from 0 (least) to 40 (worst).||units on a scale||Standard Deviation|Mean
752488|NCT00569374|Primary|Diastolic Blood Pressure|Diastolic blood pressure as a safety measure was measured by thrice weekly measuring blood pressure in mmHg.|Thrice weekly for 7 weeks|The data reported was obtained by computing the overall mean diastolic blood pressure for each participant, then using these to compute the overall mean.||mmHg||Standard Deviation|Mean
752489|NCT00569374|Primary|Systolic Blood Pressure|Systolic blood pressure as a safety measure was measured by thrice weekly measuring blood pressure in mmHg.|Thrice weekly for 7 weeks|The data reported was obtained by computing the overall mean systolic blood pressure for each participant, then using these to compute the overall mean.||mmHg||Standard Deviation|Mean
752490|NCT00569374|Primary|Heart Rate|Heart rate as a safety measure was measured by thrice weekly measuring heart rate in beats per minute.|Thrice weekly for 7 weeks|The data reported was obtained by computing the overall mean heart rate for each participant, then using these to compute the overall mean.||beats per minute||Standard Deviation|Mean
752491|NCT00569530|Secondary|Alive Without BPD at 36 Weeks Post Menstrual Age|Alive without need for oxygen at 36 weeks post menstrual age.|36 Weeks Post Menstrual Age|||Number of infants|||Number
752492|NCT00569530|Primary|SP-B Content|SP-B Content is the surfactant protein B found in terms of percentage of phospholipid measured one day after surfactant or sham dose.|One day after dose|24 of 43 in the Treatment Group and 18 of 42 in the Sham group had samples analyzed. SpB content recorded as a percentage of Total Phospholipids.||Total surfactant protein (% of PL)||Full Range|Mean
752493|NCT00569582|Primary|Decrease in Diastolic Blood Pressure.|Responder is defined as subject with a decrease greater than or equal to 5mm Hg in diastolic blood pressure from baseline to week 24 or last visit.|Baseline to Week 24|||participants|||Number
752494|NCT00569582|Primary|Improvement in Diabetes and/or Glucose Intolerance.|Responder is defined as subject with a decrease greater than or equal to 25% in area under the curve for glucose on 2-hour oral glucose test from baseline to week 24 or last visit, for Cushing's patients with type-2 diabetes mellitus/impaired glucose tolerance.|Baseline to Week 24|Patients with at least 30 days of dosing.||participants|||Number
752495|NCT00569660|Primary|Number of Participants With Objective Clinical Response|Objective Clinical Response includes Participants with Complete Response, Partial Response or Hematologic Improvement and No Response. Bone marrow aspiration and biopsy with cytogenetics every 2 to 4 courses.|Every 2 courses of 4 week therapy = each 8 weeks|The statistical analysis for response rates determined on the intent-to-treat (ITT) populations. This is defined as all enrolled patients who received at least one dose of study medication.||Participants|||Number
752496|NCT00569673|Secondary|Duration of Progression-free Survival and Overall Survival||up to 5 years||||||
752497|NCT00569673|Primary|Frequency and Severity of Adverse Events as Assessed by CTCAE v3.0||up to 5 years||||||
752498|NCT00569673|Primary|Objective Tumor Response|"Response is measured according to Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.0):
Complete Response (CR) is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart.
Partial Response (PR) is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD.
Disease Progression is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.
Stable Disease is any condition not meeting the above criteria.
Indeterminate is defined as having no repeat tumor assessments following initiation of study therapy6"|every other cycle for the first 6 months; then every 3 months x 2; then|Total number eligible and evaluable||participants|||Number
752499|NCT00569777|Primary|Visual Acuity Assessment|Visual acuity was assessed by the investigator using a Snellen visual acuity chart. This outcome counts the number of eyes that had vision of 20/40 or better at the 12 week visit.|at 12 weeks|Subjects that completed the study per protocol were included in this analysis.||Eyes|Participants||Number
752500|NCT00569777|Primary|Dilated Ophthalmoscopy - Vitreous, Change From Baseline|Assessment of changes in the vitreous (gel-like fluid of the eye), using the scale: 0=none, 0.5=trace, 1=mild, 2=moderate, 3=severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis. K-lens: missing data for 2 subjects / 4 eyes.||Units on a scale|Participants|Standard Deviation|Mean
752501|NCT00569777|Primary|Dilated Ophthalmoscopy - Fundus, Change From Baseline|Assessment of changes in abnormalities on the back part of the eye, using the scale: 0=none, 0.5=trace, 1=mild, 2=moderate, 3=severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis. K-lens: missing data for 2 subjects/4 eyes.||Units on a scale|Participants|Standard Deviation|Mean
752502|NCT00569777|Primary|Intraocular Pressure, Change From Baseline||baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.||mm of mercury|Participants|Standard Deviation|Mean
752503|NCT00569777|Primary|Corneal Staining - Central, Change From Baseline|Assessment of changes to the surface of the cornea, central region, as evaluated by the degree of staining with sodium fluorescein solution, using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.||Units on a scale|Participants|Standard Deviation|Mean
752504|NCT00569777|Primary|Corneal Staining - Superior, Change From Baseline|Assessment of changes to the surface of the cornea, upper region, as evaluated by the degree of staining with sodium fluorescein solution, using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.||Units on a scale|Participants|Standard Deviation|Mean
752505|NCT00569777|Primary|Corneal Staining - Inferior, Change From Baseline|Assessment of changes to the surface of the cornea, the bottom region, as evaluated by the degree of staining with sodium fluorescein solution, using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.||Units on a scale|Participants|Standard Deviation|Mean
752506|NCT00569777|Primary|Corneal Staining - Temporal, Change From Baseline|Assessment of changes to the surface of the cornea, the region towards the outer edge of the face, as evaluated by the degree of staining with sodium fluorescein solution, using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.||Units on a scale|Participants|Standard Deviation|Mean
752507|NCT00569777|Primary|Corneal Staining - Nasal, Change From Baseline|Assessment of changes to the surface of cornea, the region towards the nose, as evaluated by the degree of staining with sodium fluorescein solution, using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.||Units on a scale|Participants|Standard Deviation|Mean
752508|NCT00569777|Primary|Cells in Anterior Chamber, Change From Baseline|Assessment of visible cells in the anterior chamber using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.||Units on a scale|Participants|Standard Deviation|Mean
752509|NCT00569777|Primary|Flare in Anterior Chamber, Change From Baseline|Assessment of visible protein in the anterior chamber using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.||Units on a scale|Participants|Standard Deviation|Mean
752510|NCT00569777|Primary|Lens Pathology, Change From Baseline|Assessment of the clarity of the intraocular lens using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.||Units on a scale|Participants|Standard Deviation|Mean
752511|NCT00569777|Primary|Corneal Endothelial, Change From Baseline|Assessment of the posterior cornea using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.|baseline and 12 weeks|Analysis includes subjects that completed the 12 week visit per protocol.||Units on a scale|Participants|Standard Deviation|Mean
752512|NCT00569777|Primary|Corneal Erosion, Change From Baseline|Assessment of corneal erosion using the following scale: 0=none, 1=mild, 2=moderate, 3=severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.||Units on a scale|Participants|Standard Deviation|Mean
752513|NCT00569777|Primary|Corneal Edema, Change From Baseline|Assessment of corneal swelling using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.||Units on a scale|Participants|Standard Deviation|Mean
752514|NCT00569777|Primary|Conjunctival Chemosis, Change From Baseline|Assessment of swelling of the conjunctiva using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.||Units on a scale|Participants|Standard Deviation|Mean
752515|NCT00569777|Primary|Conjunctival Redness, Change From Baseline|Assessment of redness of conjunctiva using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.||Units on a scale|Participants|Standard Deviation|Mean
752518|NCT00569803|Secondary|Number of Participants With Positive Immunogenicity to Belatacept|The number of participants with positive immunogenicity to Belatacept was reported for each arm. Positive immunogenicity was defined as the presence of a positive antibody response generated against Belatacept.|Days 1, 14, 28, 42, 56, 86, 116|All participants treated with Belatacept||participants|||Number
752519|NCT00569803|Secondary|Number of Participants With Marked Laboratory Abnormalities|"LLN=Lower Limit of Normal, ULN=Upper Limit of Normal, Pre-Rx=Value before first dose. Lab values that met the following criteria were marked as abnormalities:
Glucose (mg/dL): <0.8*LLN, >1.5*ULN (if Pre-Rx<LLN: <0.8*Pre-Rx, >ULN. If Pre-Rx>ULN: >2.0*Pre-Rx, <LLN).
Protein (grams per deciliter: g/dL): <0.9*LLN, >1.1*ULN (if Pre-Rx<LLN: <0.9*Pre-Rx, >ULN. If Pre-Rx>ULN: >1.1*Pre-Rx, <LLN).
Albumin (g/dL): <0.9*LLN (if Pre-Rx<LLN: <0.9*Pre-Rx). Uric Acid (mg.dL): >1.2*ULN (if Pre-Rx>ULN: >1.25*Pre-Rx). Lactate Dehydrogenase (U/L): >1.25*ULN (if Pre-Rx>ULN: >1.5*Pre-Rx)"|Day 1 Pre-dose, Days 2, 5, 14, 28, 42, 86, 116|All treated participants||participants|||Number
752520|NCT00569803|Secondary|Number of Participants With Marked Serum Chemistry Abnormalities|"LLN=Lower Limit of Normal, ULN=Upper Limit of Normal, Pre-Rx=Value before first dose. Lab values that met the following criteria were marked as abnormalities:
Alkaline Phosphatase (units per liter: U/L), Aspartate Aminotransferase (U/L), Alanine Aminotransferase (U/L): >1.25*ULN (if Pre-Rx>ULN, use >1.25*Pre-Rx).
Bilirubin (milligrams per deciliter: mg/dL): >1.1*ULN (if Pre-Rx>ULN, use >1.25*Pre-Rx).
Blood Urea Nitrogen (mg/dL): >1.1*ULN (if Pre-Rx>ULN, use >1.2*Pre-Rx). Creatinine (mg/dL): >1.33*Pre-Rx. Sodium (milliequivalents per Liter: mEq/L): <0.95*LLN, >1.05*ULN (if Pre-Rx<LLN: <0.95*Pre-Rx, >ULN. If Pre-Rx>ULN: >1.05*Pre-Rx, <LLN).
Potassium(mEq/L), Chloride (mEq/L), Calcium(mg/dL): <0.9*LLN, >1.1*ULN (if Pre-Rx<LLN: <0.9*Pre-Rx, >ULN. If Pre-Rx>ULN: >1.1*Pre-Rx, <LLN).
Phosphorus (mg/dL): <0.85*LLN, >1.25*ULN (if Pre-Rx<LLN, <0.85*Pre-Rx, >ULN. if Pre-Rx>ULN: >1.25*Pre-Rx, <LLN)."|Day 1 Pre-dose, Days 2, 5, 14, 28, 42, 86, 116|All treated participants||participants|||Number
752521|NCT00569803|Secondary|Number of Participants With Marked Hematology Laboratory Abnormalities|"LLN=Lower Limit of Normal, ULN=Upper Limit of Normal, Pre-Rx=Value before first dose. Lab values that met the following criteria were marked as abnormalities:
Hemoglobin (grams per deciliter:g/dL): <0.85*Pre-Rx. Hematocrit (%): <0.85*Pre-Rx. Platelet Count (*10^9 cells per liter:c/L): <0.85*LLN or >1.5*ULN (if Pre-Rx<LLN, use <0.85*Pre-Rx).
Leukocytes (*10^3 cells per microliter: c/uL): <0.9*LLN, >1.2*ULN (if Pre-Rx<LLN, use <0.85*Pre-Rx or >ULN, if Pre-Rx>ULN, use >1.15*Pre-Rx or <LLN) Neutrophils+Bands (*10^3 c/uL): <=1.500. Lymphocytes (*10^3 c/uL): <0.750 or >7.500. Monocytes (*10^3 c/uL): >2.000. Basophils (*10^3 c/uL): >0.400. Eosinophils (*10^3 c/uL): >0.750."|Day 1 Pre-dose, Days 2, 5, 14, 28, 42, 86, 116|All treated participants||participants|||Number
752522|NCT00569803|Secondary|Number of Participants With Electrocardiogram (ECG) Abnormalities|Participants underwent a 12-lead ECG assessment at Screening (Day 1) and Study Discharge (Day 116). All investigator-assessed ECG abnormalities were reported.|Days 1 and 116|All treated participants||participants|||Number
752523|NCT00569803|Secondary|Number of Participants With Physical Examination Abnormalities|All clinically significant deviations from normal physical examinations were reported.|Days 1, 2, 5, 14, 28, 42, 86, 116|All treated participants||participants|||Number
752524|NCT00569803|Secondary|Number of Participants With Injection Site Reactions|Participants were assessed for erythema, heat, pain, pruritis and swelling at the injection sites and were characterized by the investigator as mild, moderate or severe reactions.|0.5, 2, 6 and 24 hours post-dose, Days 3, 4, 5, 6, 7, 8, 14, 21 and 116|All treated participants||participants|||Number
752525|NCT00569803|Secondary|Number of Participants With Vital Sign Abnormalities|Vital signs (body temperature, respiratory rate, seated blood pressure, and heart rate) were recorded at screening. All significant findings were evaluated by the investigator, and all abnormalities were listed.|1 day pre-dose, Days 1, 2, 5, 14, 28, 42, 86 and 116|All treated participants||participants|||Number
752526|NCT00569803|Secondary|Effect of Number of Injection Sites on Subcutaneous Belatacept Absorption|"AUC(0-T) and AUC(INF) for Belatacept were derived from serum concentration versus time data to assess the effect of number of injection sites on the subcutaneous absorption of Belatacept. All treatments were dose-normalized to 50mg. Adjusted geometric means reported in microgram hours per milliliter (ug*h/mL).
AUC(0-T) = Area Under the Serum Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration.
AUC(INF) = Area Under the Serum Concentration-time Curve From Time Zero Extrapolated to Infinite Time."|Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116|All participants treated with Belatacept||ug*h/mL||90% Confidence Interval|Geometric Mean
752527|NCT00569803|Primary|Apparent Volume of Distribution at Steady State (Vss/F) for SC Belatacept|Apparent volume of distribution at steady state (Vss/F) was derived from concentration versus time data for all participants treated with subcutaneous (SC) Belatacept.|Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116|All participants treated with SC Belatacept||Liters||Geometric Coefficient of Variation|Geometric Mean
752528|NCT00569803|Primary|Volume of Distribution at Steady State (VSS) for IV Belatacept|Volume of distribution at steady state (VSS) was derived from serum concentration versus time data for all participants treated with IV Belatacept.|Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116|All participants treated with IV Belatacept||Liters||Standard Deviation|Mean
752529|NCT00569803|Primary|Total Body Clearance (CLT) of IV Belatacept|Total body clearance (CLT) was derived from serum concentration versus time data for all participants that were treated with IV Belatacept. Units reported in milliliters per hour (mL/h)|Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116|All participants treated with IV Belatacept||mL/h||Geometric Coefficient of Variation|Geometric Mean
752530|NCT00569803|Primary|Apparent Total Body Clearance (CLT/F) of SC Belatacept|Apparent total body clearance (CLT/F) was derived from serum concentration versus time data for all participants who received subcutaneous (SC) Belatacept injections. Units reported in milliliters per hour (mL/h).|Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116|All participants treated with SC Belatacept||mL/h||Geometric Coefficient of Variation|Geometric Mean
752531|NCT00569803|Primary|Serum Half-life (T-HALF) of Belatacept|Serum half-life (T-HALF) was determined from serum concentration versus time data and was reported in hours.|Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116|All participants treated with Belatacept||hours||Standard Deviation|Mean
752532|NCT00569803|Primary|Adjusted Geometric Means of Area Under the Serum Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) for Belatacept|Area under the serum concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) was derived from serum concentration versus time data. Adjusted geometric means were reported in microgram hours per milliliter (ug*h/mL)|Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116|All participants treated with Belatacept||ug*h/mL||90% Confidence Interval|Geometric Mean
752533|NCT00569803|Primary|Adjusted Geometric Means of Area Under the Serum Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC(0-T)) for Belatacept|Area under the serum concentration-time curve from time zero to the time of last quantifiable concentration (AUC(0-T)) was derived from serum concentration versus time data. Adjusted geometric means were reported in microgram hours per milliliter (ug*h/mL).|Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116|All participants treated with Belatacept||ug*h/mL||90% Confidence Interval|Geometric Mean
752534|NCT00569803|Primary|Time of Maximum Observed Serum Concentration (Tmax) of Belatacept|Time of maximum observed serum concentration (Tmax) values were derived from serum concentration versus time data for all participants treated with Belatacept.|Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116|All participants treated with Belatacept||hours||Full Range|Median
752535|NCT00569803|Primary|Maximum Observed Serum Concentration (Cmax) of Belatacept|Maximum observed serum concentration (Cmax) values were derived from serum concentration versus time data and reported in micrograms per milliliter (ug/mL).|Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116|All participants treated with Belatacept||ug/mL||Geometric Coefficient of Variation|Geometric Mean
752536|NCT00569855|Primary|Number of Participants Who Had Significant Hypotension as Defined in the Protocol as Need for Norepinephrine Dose >0.1mcq/kg/Min in the First 72 Hours Postoperatively|Number of subjects who required Norepinephrine >0.1mcq/kg/min|72 hours postoperatively|No. of subjects consented = 832; 785 subjects received study drug||participants|||Number
752537|NCT00569868|Primary|Antithrombotic Effect of VELCADE in a Malignancy Associated With a Hypercoagulable State in Patients With Relapsed/Refractory Multiple Myeloma.|"Goal is to evaluate changes in coagulation (blood clotting) in refractory/relapsing multiple myeloma patients during VELCADE treatment.
Before and during treatment, participant will undergo routine tests/procedures following the Myeloma Institute’s guidelines (physical exams, blood, urine, and bone tests, and bone marrow aspirates and biopsies) and will also receive a series of coagulation tests before treatment and after 1st and 3rd doses of each cycle.
Response measured as: complete, partial, or minimal response, no change, progressive disease, or relapse from complete response."|60 days|no analysis done, descriptive information on the magnitude, direction, and variability of changes in coagulation factors and platelet function in refractory/relapsing multiple myeloma patients during VELCADE treatment was collected||participants|||Number
752538|NCT00569946|Secondary|Number of Participants With Adverse Events|Number of participants with any adverse events, adverse events graded as Common Terminology Criteria (CTCAE) for Adverse Events Version 3.0 Grade 3 or higher , serious adverse events, or adverse events resulted in discontinuation.|Up to 1709 days of treatment plus 28-days follow-up|The Intent-To-Treat (ITT) population included all participants enrolled in the study who received at least 1 dose of study medication.||participants|||Number
752539|NCT00569946|Secondary|Plasma Concentration of Vascular Endothelial Growth Factor (VEGF)||Cycle 1 Day 1 predose, Day 1 of Cycle 2 to Cycle 7, and end of treatment/discontinuation (assessed up to 1709 days)|Biomarker analysis set included all participants enrolled in the study who received at least 1 dose of study medication and who submitted at least 1 sample; n=number of participants assessed.||pg/mL||Full Range|Median
752540|NCT00569946|Secondary|Plasma Concentration of Soluble Stem Cell Factor Receptor (s-KIT)||Cycle 1 Day 1 predose, Day 1 of Cycle 2 to Cycle 7, and end of treatment/discontinuation (assessed up to 1709 days)|Biomarker analysis set included all participants enrolled in the study who received at least 1 dose of study medication and who submitted at least 1 sample; n=number of participants assessed.||pg/mL||Full Range|Median
752541|NCT00569946|Secondary|Plasma Concentration of Soluble Vascular Endothelial Growth Factor Receptor 3 (s-VEGFR3)||Cycle 1 Day 1 predose, Day 1 of Cycle 2 to Cycle 7, and end of treatment/discontinuation (assessed up to 1709 days)|Biomarker analysis set included all participants enrolled in the study who received at least 1 dose of study medication and who submitted at least 1 sample; n=number of participants assessed.||pg/mL||Full Range|Median
752542|NCT00569946|Secondary|Plasma Concentration of Soluble Vascular Endothelial Growth Factor Receptor 2 (s-VEGFR2)||Cycle 1 Day 1 predose, Day 1 of Cycle 2 to Cycle 7, and end of treatment/discontinuation (assessed up to 1709 days)|Biomarker analysis set included all participants enrolled in the study who received at least 1 dose of study medication and who submitted at least 1 sample; n=number of participants assessed.||pg/mL||Full Range|Median
752543|NCT00569946|Secondary|Plasma Concentration of Soluble Vascular Endothelial Growth Factor Receptor 1 (s-VEGFR1)||Cycle 1 Day 1 predose, Day 1 of Cycle 2 to Cycle 7, and end of treatment/discontinuation (assessed up to 1709 days)|Biomarker analysis set included all participants enrolled in the study who received at least 1 dose of study medication and who submitted at least 1 sample; n=number of participants assessed.||pg/mL||Full Range|Median
752544|NCT00569946|Secondary|Number of Participants Analyzed for Population Pharmacokinetics of AG-013736|Population pharmacokinetic analysis of AG-013736 is conducted by combining current study data with other AG-013736 studies.|Cycle 1 Day 1 (2 hours after morning dose); Cycles 3, 5, and 7 Day 1 predose and 2 hours post morning dose|No population pharmacokinetic analysis results are available just for the current study.|||||
752545|NCT00569946|Secondary|Overall Survival (OS)|"OS was defined as the time from date of first dose of AG-013736 to date of death due to any cause.
Subjects in whom death is not reported will have their event time censored on the last date the subject is known to be alive."|Up to 2002 days (maximum duration of treatment plus follow-up observation)|The Intent-To-Treat (ITT) population included all participants enrolled in the study who received at least 1 dose of study medication.||months||95% Confidence Interval|Median
752624|NCT00561600|Secondary|Analysis of Metal Ion Release - Erythrocyte Cobalt|Erythrocyte cobalt|36 months|Metal ion sub-study was limited to two sites. All participants with available data are presented below.||ug/L||Full Range|Median
752546|NCT00569946|Secondary|Duration of Response|Time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.44. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Start of first confirmed CR or PR to the date of the first event (PD or death) or the last tumor assessment, whichever came first, assessed up to 1709 days.|The Intent-To-Treat (ITT) population included all participants enrolled in the study who received at least 1 dose of study medication. DR was calculated for the subgroup of participants with a confirmed objective tumor response. n=number of participants assessed as CR or PR.||months||95% Confidence Interval|Median
752547|NCT00569946|Secondary|Time to Tumor Progression (TTP)|Time in months from start of study treatment to first documentation of objective tumor progression. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.44. Tumor progression was determined from radiological image (where data meet the criteria for progressive disease [PD]).|Up to 1709 days of treatment|The Intent-To-Treat (ITT) population included all participants enrolled in the study who received at least 1 dose of study medication.||months||95% Confidence Interval|Median
752548|NCT00569946|Secondary|Progression-Free Survival (PFS)|Time in months from start of study treatment to first documentation of objective tumor progression or death due to any cause whichever comes first. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.44. Tumor progression was determined from radiological image (where data meet the criteria for progressive disease [PD]).|Up to 1709 days of treatment|The Intent-To-Treat (ITT) population included all participants enrolled in the study who received at least 1 dose of study medication.||months||95% Confidence Interval|Median
752549|NCT00569946|Primary|Objective Response Rate (Percentage of Participants With Complete Response [CR] or Partial Response [PR]): Investigators Assessment|Percentage of participants with objective response based assessment of confirmed CR or confirmed PR by the investigator, according to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0). CR was defined as the disappearance of all target and nontarget lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters of the targeted lesions. CR and PR had to be documented on 2 occasions separated by at least 4 weeks.|Up to 765 days of treatment at the data cut-off date|The Intent-To-Treat (ITT) population included all participants enrolled in the study who received at least 1 dose of study medication.||percentage of participants||95% Confidence Interval|Number
752550|NCT00569946|Primary|Objective Response Rate (Percentage of Participants With Complete Response [CR] or Partial Response [PR]): Independent Review Committee Assessment|Percentage of participants with objective response based assessment of confirmed CR or confirmed PR by the Independent Review Committee, according to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0). CR was defined as the disappearance of all target and nontarget lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters of the targeted lesions. CR and PR had to be documented on 2 occasions separated by at least 4 weeks.|Up to 765 days of treatment at the data cut-off date|The Intent-To-Treat (ITT) population included all participants enrolled in the study who received at least 1 dose of study medication.||percentage of participants||95% Confidence Interval|Number
752551|NCT00570037|Primary|Influenza Vaccine Coverage (Percent) for All Household Contacts of Newborns|The percent of all household contacts of newborns who as reported by new mothers received an influenza vaccine during the mothers pregnancy, in the hospital after delivery, or during the 6 to 8 week period following the birth of their baby|Pregnancy period through 6 to 8 weeks postpartum|||Percentage of All Household Contacts|||Number
752552|NCT00570037|Primary|Influenza Vaccine Coverage (Percent) for New Fathers of Newborns|The percent of new fathers who as reported by new mothers received an influenza vaccine during the mothers pregnancy, in the hospital after delivery, or during the 6 to 8 week period following the birth of their baby|Pregnancy period through 6 to 8 weeks postpartum|||Percentage of Fathers of Newborns|||Number
752553|NCT00570037|Primary|Influenza Vaccine Coverage (Percent) for New Mothers of Newborns|The percent of new mothers delivering at the hospital who reported receiving an influenza vaccine during their pregnancy, in the hospital after delivery, or during the 6 to 8 week postpartum period|Pregnancy period through 6 to 8 weeks postpartum|||Percentage of Participants|||Number
752556|NCT00570141|Primary|Percent Wounds Closed|"Wound healing was assessed weekly, spaced 7 +/- 1 day apart, up to 12 weeks or until the wound healed, whichever occurred first.
The outcome value was based on the percent of wounds which were closed at the end of the study (at 12 weeks). The percent wounds closed were calculated for each wound type: Diabetic Foot Ulcers (DFU) and Venous Stasis Ulcers (VSU)."|baseline and 12 weeks|Analysis was Per Protocol||Percent of Wounds Closed|||Number
752557|NCT00570141|Primary|Decrease in Wound Area From Baseline After 12 Weeks of Treatment or Until Wound Closure, Whichever Occurred First.|"Wound measurements were made weekly, spaced 7 +/- 1 day apart, up to 12 weeks or until the wound healed, whichever occurred first.
The final measurement taken was subtracted from the baseline to assess the decrease in wound area after treatment.
Final calculation is mean baseline measurement minus final measurement at 12 weeks (or when wound healed, whichever occurred first)"|Baseline and weekly up to 12 weeks|Analysis was Per Protocol||cm2||Standard Deviation|Mean
752558|NCT00561340|Primary|Height Change|Change in height from baseline to 6 months|6 months|29 of 33 eligible subjects were enrolled. 4 subjects were not eligible for randomization as they were not appropriate candidates for caloric supplementation. Of the 13 randomized to Pediasure, 6 subjects refused to drink it. Data is presented for any subject who drank any Pediasure.||centimeters||Standard Deviation|Mean
752559|NCT00561340|Primary|Weight Change|Change in weight observed from baseline to 6 months|6 months|29 of 33 eligible subjects were enrolled. 4 subjects were not eligible for randomization as they were not appropriate candidates for caloric supplementation. Of the 13 randomized to Pediasure, 6 subjects refused to drink it. Data is presented for any subject who drank any Pediasure.||kilograms||Standard Deviation|Mean
752560|NCT00561353|Secondary|Area Under the Plasma Concentration-time Curve From the Time of Administration to 24 Hours After Dosing (AUC24h) of TMC435 in Treatment-Naïve Hepatitis C Virus (HCV)-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)|The table below shows mean (standard deviation) values of the area under the plasma concentration-time curve from time of administration to 24 hours after dosing for TMC435 in treatment-experienced HCV-infected participants considered non-responders (participants who achieved less than a 2 log10 IU/mL decline from baseline in plasma HCV ribonucleic acid (RNA) levels after 12 weeks of previous interferon [IFN]-based therapy [pegylated or non-pegylated]) or relapsers (defined as a participant with undetectable plasma HCV RNA at the end of treatment of previous IFN-based therapy and subsequent confirmed detectable plasma HCV RNA levels during follow-up at selected time points following treatment with TMC435 coadministered with ribavirin (RBV) for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22. The number of participants analyzed at Day 28 in the 4 treatment groups listed below from left to right was 8, 7, 10, and 3.|Days 1 and 28 (predose and 0.5, 1, 2, 4, 6, 8, and 10 hours postdose)|All participants who received treatment were included in the pharmacokinetic (PK) analysis, however, due to various reasons (ie, missing samples at certain time points, or exclusion of specific plasma concentrations from the PK analysis) not all PK parameters could always be calculated for each participant.||ng.h/mL||Standard Deviation|Mean
752561|NCT00561353|Secondary|Area Under the Plasma Concentration-time Curve From the Time of Administration to 24 Hours After Dosing (AUC24h) of TMC435 in Treatment-Naïve Hepatitis C Virus (HCV)-Infected Participants (Cohort 1 and 2, Panel A and B)|The table below shows mean (standard deviation) values of the area under the plasma concentration-time curve from time of administration to 24 hours after dosing for TMC435 in treatment-naïve HCV-infected participants administered TMC435 for 7 days followed by TMC435 coadministered with ribavirin for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22 (Panel A) and with TMC435 coadministered with ribavirin for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).The number of participants analyzed at Day 28 in the 6 treatment groups listed below from left to right were 9, 8, 7, 9, 9, and 10.|Days 1 and 28 (predose and 0.5, 1, 2, 4, 6, 8, and 10 hours postdose)|All participants who received treatment were included in the pharmacokinetic (PK) analysis, however, due to various reasons (ie, missing samples at certain time points, or exclusion of specific plasma concentrations from the PK analysis) not all PK parameters could always be calculated for each participant.||ng.h/mL||Standard Deviation|Mean
752562|NCT00561353|Secondary|Average Steady-state Plasma Concentration (Css,av) of TMC435 in Treatment-Experienced Hepatitis C Virus (HCV)-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)|The table below shows mean (standard deviation) of Css,av for TMC435 in treatment-experienced HCV-infected participants (non-responders and relapsers, see defined above) at selected time points following treatment with TMC435 coadministered with ribavirin for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.|Day 28 (predose and 0.5, 1, 2, 4, 6, 8, and 10 hours postdose)|All participants who received treatment were included in the pharmacokinetic (PK) analysis, however, due to various reasons (ie, missing samples at certain time points, or exclusion of specific plasma concentrations from the PK analysis) not all PK parameters could always be calculated for each participant.||ng/ml||Standard Deviation|Mean
752563|NCT00561353|Secondary|Average Steady-state Plasma Concentration (Css,av) of TMC435 in Treatment-Naïve Hepatitis C Virus (HCV)-Infected Participants (Cohort 1 and 2, Panel A and B)|"The table below shows mean (standard deviation)of Css,av for TMC435 in treatment-naïve HCV-infected participants at selected time points administered TMC435 for 7 days followed by TMC435 coadministered with ribavirin for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22 (Panel A) and with TMC435 coadministered with ribavirin for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B). See treatment-naïve defined above. The number of participants analyzed at Day 28 in the 6 treatment groups listed below from left to right were 9, 8, 7, 9, 9, and 10."|Day 7 (predose); Day 28 (predose and 0.5, 1, 2, 4, 6, 8, and 10 hours postdose) (Panel A, Cohorts 1 and 2) and Day 28 (predose and 0.5, 1, 2, 4, 6, 8, and 10 hours postdose) (Panel B, Cohorts 1 and 2)|All participants who received treatment were included in the pharmacokinetic (PK) analysis, however, due to various reasons (ie, missing samples at certain time points, or exclusion of specific plasma concentrations from the PK analysis) not all PK parameters could always be calculated for each participant.||ng/ml||Standard Deviation|Mean
752564|NCT00561353|Secondary|Predose Plasma Concentration (C0h) of TMC435 in Treatment-Experienced Hepatitis C Virus (HCV)-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)|The table below shows mean (standard deviation) of C0h for treatment-experienced participants (non-responders and relapsers, see defined above) following treatment with TMC435 coadministered with ribavirin for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22. The number of participants analyzed at Day 2 and Day 28 differed as follows: At Day 2, the number of participants in the 4 treatment groups (from left to right) were 8, 7, 10, and 5; the number of participants analyzed at Day 28 in the 4 treatment groups (from left to right) were 9, 8, 10, and 4.|Day 2 (predose) and Day 28 (predose and 0.5, 1, 2, 4, 6, 8, and 10 hours postdose)|All participants who received treatment were included in the pharmacokinetic (PK) analysis, however, due to various reasons (ie, missing samples at certain time points, or exclusion of specific plasma concentrations from the PK analysis) not all PK parameters could always be calculated for each participant.||ng/mL||Standard Deviation|Mean
752625|NCT00561600|Secondary|Analysis of Metal Ion Release - Serum Chromium|Serum Chromium|36 months|Metal ion sub-study was limited to two sites. All participants with available data are presented below.||ug/L||Full Range|Median
752626|NCT00561600|Secondary|Analysis of Metal Ion Release - Serum Cobalt|Serum Cobalt|36 months|Metal ion sub-study was limited to two sites. All participants with available data are presented below.||ug/L||Full Range|Median
752565|NCT00561353|Secondary|Predose Plasma Concentration (C0h) of TMC435 in Treatment-Naïve Hepatitis C Virus (HCV)-Infected Participants (Cohort 1 and 2, Panel A and B)|"The table below shows mean (standard deviation) of C0h of TMC435 at selected time points following treatment with TMC435 for 7 days followed by TMC435 coadministered with ribavirin for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22 (Panel A) or with TMC435 coadministered with ribavirin for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B) in treatment-naïve participants (see treatment-naïve defined above).The number of participants analyzed at Day 28 in the 6 treatment groups listed below from left to right were 9, 9, 8, 9, 9, and 10."|Day 2 (predose) and Day 28 (predose and 0.5, 1, 2, 4, 6, 8, and 10 hours postdose)|All participants who received treatment were included in the pharmacokinetic (PK) analysis, however, due to various reasons (ie, missing samples at certain time points, or exclusion of specific plasma concentrations from the PK analysis) not all PK parameters could always be calculated for each participant.||ng/ml||Standard Deviation|Mean
752566|NCT00561353|Secondary|Maximum Plasma Concentration (Cmax) of TMC435 in Treatment-Experienced Hepatitis C Virus (HCV)-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)|The table below shows the mean (standard deviation) Cmax for treatment-experienced participants (non-responders and relapsers, see defined above) following treatment with TMC435 coadministered with ribavirin for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22. The number of participants analyzed at Day 28 in the 4 treatment groups listed below from left to right were 8, 8, 10, and 3.|Days 1 and 28 (predose and 0.5, 1, 2, 4, 6, 8, and 10 hours postdose)|All participants who received treatment were included in the pharmacokinetic (PK) analysis, however, due to various reasons (ie, missing samples at certain time points, or exclusion of specific plasma concentrations from the PK analysis) not all PK parameters could always be calculated for each participant.||ng/mL||Standard Deviation|Mean
752567|NCT00561353|Secondary|Maximum Plasma Concentration (Cmax) of TMC435 in Treatment-Naïve Hepatitis C Virus (HCV)-Infected Participants (Cohort 1 and 2, Panel A and B)|"The table below shows the mean (standard deviation) Cmax for treatment-naïve participants at selected time points who were treated with TMC435 for 7 days followed by TMC435 coadministered with ribavirin for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22 (Panel A) and with TMC435 coadministered with ribavirin for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B). See treatment-naïve defined above. The number of participants analyzed at Day 28 in the 6 treatment groups listed below from left to right were 9, 8, 7, 9, 9, and 10."|Days 1 and 28 (predose and 0.5, 1, 2, 4, 6, 8, and 10 hours postdose)|All participants who received treatment were included in the pharmacokinetic (PK) analysis, however, due to various reasons (ie, missing samples at certain time points, or exclusion of specific plasma concentrations from the PK analysis) not all PK parameters could always be calculated for each participant.||ng/mL||Standard Deviation|Mean
752568|NCT00561353|Secondary|Sustained Virologic Response (SVR) in Treatment-Experienced Hepatitis C Virus (HCV)-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)|The table below shows the number of treatment-experienced participants (non-responders and relapsers, see defined above) in each treatment group in Cohort 4, Panel C and in Cohort 5, Panel D with an SVR to treatment defined as having an undetectable plasma level of HCV ribonucleic acid after the last planned dose of the entire treatment regimen. SVR was measured at 4, 8, 12, and 24 weeks after the last dose of treatment (SVR4, SVR8, SVR12, and SVR24, respectively).|SVR4 (Week 52), SVR8 (Week 56), SVR12 (Week 60), and SVR24 (Week 72)|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Participants|||Number
752569|NCT00561353|Secondary|Sustained Virologic Response (SVR) in Treatment-Naïve Hepatitis C Virus (HCV)-Infected Participants (Cohort 1 and 2, Panel A and B Combined)|"The table below shows the number of treatment-naïve participants with an SVR to treatment (defined as having an undetectable plasma level of HCV ribonucleic acid after the last planned dose of treatment) for the treatment groups in Cohort 1 (Panel A and B combined) and in Cohort 2 (Panel A and B combined). SVR was measured at 4, 8, 12, and 24 weeks after the last dose of treatment (SVR4, SVR8, SVR12, and SVR24, respectively). See treatment-naïve defined above."|SVR4 (Week 52), SVR8 (Week 56), SVR12 (Week 60), and SVR24 (Week 72)|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Participants|||Number
752570|NCT00561353|Secondary|Viral Relapse in Treatment-Experienced Hepatitis C Virus (HCV)-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)|The table below shows the number of treatment-experienced participants combined (non-responders and relapsers, see defined above) with viral relapse, defined as having confirmed detectable plasma level of HCV ribonucleic acid (RNA) during the follow-up period in participants with undetectable plasma HCV RNA (less than 25 IU/mL undetectable) at the end of treatment who received TMC435 or placebo coadministered with ribavirin for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.|Up to Week 72|The analysis population used to evaluate viral relapse included participants in the intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) who were treatment-experienced and had undetectable plasma HCV RNA (less than 25 IU/mL undetectable) at the end of treatment.||Participants|||Number
752571|NCT00561353|Secondary|Viral Relapse in Treatment-Naïve Hepatitis C Virus (HCV)-Infected Participants (Cohort 1 and 2, Panel A and B Combined)|"The table below shows the number of treatment-naïve participants with viral relapse (defined as having confirmed detectable plasma level of HCV ribonucleic acid [RNA] during the follow-up period in participants with undetectable plasma HCV RNA [less than 25 IU/mL undetectable] at the end of treatment) for the treatment groups in Cohort 1 (Panel A and B combined) and in Cohort 2 (Panel A and B combined). See treatment-naïve defined above."|Up to Week 72|The analysis population used to evaluate viral relapse included participants in the intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) who were treatment-naïve and had undetectable plasma HCV RNA (less than 25 IU/mL undetectable) at the end of treatment.||Participants|||Number
752627|NCT00561600|Secondary|Analysis of Metal Ion Release - Erythrocyte Chromium|Erythrocyte Chromium|24 months|Metal ion sub-study was limited to two sites. All participants with available data are presented below.||ug/L||Full Range|Median
752628|NCT00561600|Secondary|Analysis of Metal Ion Release - Erythrocyte Cobalt|Erythrocyte Cobalt|24 months|Metal ion sub-study was limited to two sites. All participants with available data are presented below.||ug/L||Full Range|Median
752572|NCT00561353|Secondary|Viral Breakthrough in Treatment-Experienced Hepatitis C Virus (HCV)-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)|The table below shows the number of treatment-experienced participants (non-responders and relapsers, see defined above) with viral breakthrough, defined as a confirmed increase of greater than 1 log10 IU/mL in plasma HCV ribonucleic acid (RNA) level from the lowest level reached), or a confirmed plasma HCV RNA level of greater than 100 IU/mL in participants whose plasma HCV RNA had previously been below the limit of quantification (25 IU/mL detectable) or undetectable (less than 25 IU/mL undetectable) treated with TMC435 or placebo coadministered with ribavirin for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.|4 Weeks (Wks), 44 Wks, and 48 Wks|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Participants|||Number
752573|NCT00561353|Secondary|Viral Breakthrough in Treatment-Naïve Hepatitis C Virus (HCV)-Infected Participants (Cohort 1, Panel A and B)|The table below shows the number of treatment-naïve participants with viral breakthrough, defined as a confirmed increase of greater than 1 log10 IU/mL in plasma HCV ribonucleic acid (RNA) level from the lowest level reached, or a confirmed plasma HCV RNA level of greater than 100 IU/mL in participants whose plasma HCV RNA had previously been below the limit of quantification (25 IU/mL detectable) or undetectable (less than 25 IU/mL undetectable) after treatment with TMC435 or placebo for 7 days followed by TMC435 or placebo coadministered with ribavirin for 21 days + peginterferon alpha-2a (PegIFNα-2a) on days 8, 15, and 22 (Panel A) and after treatment with TMC435 or placebo coadministered with ribavirin for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).|4 Weeks (Wks), 44 Wks, and 48 Wks|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses. Note: Number of participants analyzed during the PegIFNα-2a and ribavirin treatment period of up to 44 weeks is N=16 for TMC435 25 mg, N=17 for TMC435 75 mg, and N=17 for TMC435 200 mg.||Participants|||Number
752574|NCT00561353|Secondary|Initial Suboptimal Responses Following Treatment With TMC435 in Treatment-Experienced Hepatitis C Virus (HCV)-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)|The table below shows the number of treatment-experienced participants (non-responders and relapsers, see defined above) with an initial suboptimal response defined as less than 2 log10 change of plasma in plasma level of HCV ribonucleic acid (RNA) at Day 2 or 3 (depending when visit was scheduled) treated with TMC435 or placebo coadministered with ribavirin for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.|Day 2 or 3|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Participants|||Number
752575|NCT00561353|Secondary|Initial Suboptimal Responses Following Treatment With TMC435 in Treatment-Naïve Hepatitis C Virus (HCV)-Infected Participants (Cohort 1 and 2, Panel B)|"The table below shows the number of treatment-naïve participants with an initial suboptimal response defined as less than 2 log10 change in plasma plasma level of hepatitis C virus (HCV) ribonucleic acid (RNA) on Day 2 or 3 (depending when visit was scheduled) after treatment with TMC435 or placebo coadministered with ribavirin for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22. See treatment-naive defined above."|Day 2 or 3|The intent-to-treat (ITT) population, defined as all participants who were randomized and received at least one dose of study medication (TMC435) was used for all analyses.||Participants|||Number
752576|NCT00561353|Secondary|Initial Suboptimal Responses Following Treatment With TMC435 in Treatment-Naïve Hepatitis C Virus (HCV)-Infected Participants (Cohort 1 and 2, Panel A)|"The table below shows the number of treatment-naïve participants with an initial suboptimal response defined as less than 2 log10 change in plasma level of hepatitis C virus (HCV) ribonucleic acid (RNA) on Day 2 or 3 (depending when visit was scheduled) following treatment with TMC435 or placebo for 7 days followed by TMC435 or placebo coadministered with ribavirin for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22. See treatment-naive defined above."|Day 2 or 3|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Participants|||Number
752577|NCT00561353|Secondary|Virologic Response Parameters Following Treatment With TMC435 in Treatment-Experienced Hepatitis C Virus (HCV)-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)|The table below shows the number of treatment-experienced participants (non-responders and relapsers, see defined above) treated with TMC435 or placebo coadministered with ribavirin for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22 who met the following virologic response parameters: rapid virological response (RVR) defined as having undetectable plasma HCV ribonucleic acid (RNA) at Week 4; early virologic response (EVR) defined as change from baseline in plasma HCV RNA of greater than or equal to 2 log 10 at Week 12; a complete EVR (cEVR) defined as a EVR having undetectable plasma HCV RNA at Week 12; an extended RVR (eRVR) defined as undetectable plasma HCV RNA at Week 4 and 12; and a partial response defined as EVR but not reaching undetectability while on treatment.|Week 4 (RVR), Week 12 (EVR, cEVR, and partial response), and Week 4 and 12 (eRVR)|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Participants|||Number
752578|NCT00561353|Secondary|Virologic Response Parameters in Treatment-Naïve Hepatitis C Virus (HCV)-Infected Participants (Cohort 1 and 2, Panel A and B Combined)|The table below shows the number of treatment-naïve participants in the treatment groups for Cohort 1 (Panel A and B combined) and in Cohort 2 (Panel A and B combined) who met the following virologic response parameters: rapid virological response (RVR) defined as having undetectable plasma HCV ribonucleic acid (RNA) at Week 4; early virologic response (EVR) defined as change from baseline in plasma HCV RNA of greater than or equal to 2 log 10 at Week 12); a complete EVR (cEVR) defined as a complete EVR having undetectable plasma HCV RNA at Week 12); an extended RVR (eRVR) defined as undetectable plasma HCV RNA at Week 4 and 12; and a partial response defined as EVR but not reaching undetectability while on treatment.|Week 4 (RVR), Week 12 (EVR, cEVR, and partial response), and Week 4 and 12 (eRVR)|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Participants|||Number
752629|NCT00561600|Secondary|Analysis of Metal Ion Release - Serum Chromium|Serum Chromium|24 months|Metal ion sub-study was limited to two sites. All participants with available data are presented below.||ug/L||Full Range|Median
752630|NCT00561600|Secondary|Analysis of Metal Ion Release - Serum Cobalt|Serum Cobalt|24 months|Metal ion sub-study was limited to two sites. All participants with available data are presented below.||ug/L||Full Range|Median
752579|NCT00561353|Secondary|Virologic Responses Following Treatment With TMC435 in Treatment-Experienced Hepatitis C Virus (HCV)-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)|The table below shows the number of treatment-experienced participants (non-responders and relapsers, see defined above) with the following virologic responses to treatment with TMC435 or placebo coadministered with ribavirin for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22: plasma levels of HCV ribonucleic acid (RNA) of greater than or equal to 2 log10 decline from Baseline; plasma levels of HCV RNA below the limit of quantification (ie, less than [<] 25 IU/mL detectable or undetectable); plasma levels of HCV RNA below the limit of detection (ie, <25 IU/mL undetectable); plasma levels of HCV RNA <100 IU/mL; and plasma levels of HCV RNA <1000 at the time points listed. Note: in the table below, the number of participants (n) analyzed in the TMC435 200 mg (Cohort 4, Panel B) on Day 28 (Week 4) was n=4.|Day 2 or 3, Day 7, and Day 28|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Participants|||Number
752580|NCT00561353|Secondary|Virologic Responses Following Treatment With TMC435 in Treatment-Naive Hepatitis C Virus (HCV)-Infected Participants (Cohort 1 and 2, Panel B)|"The table below shows the number of treatment-naive HCV-Infected participants with the following virologic responses to treatment with TMC435 or placebo coadministered with ribavirin for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22: plasma levels of HCV ribonucleic acid (RNA) of greater than or equal to 2 log10 decline from Baseline; plasma levels of HCV RNA below the limit of quantification (ie, less than [<] 25 IU/mL detectable or undetectable); plasma levels of HCV RNA below the limit of detection (ie, <25 IU/mL undetectable); plasma levels of HCV RNA <100 IU/mL; and plasma levels of HCV RNA <1000 at the time points listed. See treatment-naive defined above."|Day 2 or 3, Day 7, and Day 28|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Participants|||Number
752581|NCT00561353|Secondary|Virologic Responses Following Treatment With TMC435 in Treatment-Naive Hepatitis C Virus (HCV)-Infected Participants (Cohort 1 and 2, Panel A)|"The table below shows the number of treatment-naïve HCV-infected participants treated with TMC435 or placebo for 7 days followed by TMC435 or placebo coadministered with ribavirin for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22 who had the following virologic responses: plasma levels of HCV ribonucleic acid (RNA) of greater than or equal to 2 log10 decline from Baseline; plasma levels of HCV RNA below the limit of quantification (ie, less than [<] 25 IU/mL detectable or undetectable); plasma levels of HCV RNA below the limit of detection (ie, <25 IU/mL undetectable); plasma levels of HCV RNA <100 IU/mL; and plasma levels of HCV RNA <1000 at the time points listed. See treatment-naive defined above."|Day 2 or 3, Day 7, and Day 28|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Participants|||Number
752582|NCT00561353|Secondary|Change From Baseline in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (log10 IU/mL) on Day 7 in Treatment-Experienced HCV-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)|The table below shows the change from Baseline in plasma levels of HCV RNA on Day 7 (Week 1) following treatment with TMC435 or placebo coadministered with ribavirin for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22 in treatment-experienced participants considered non-responders (defined as participants who achieved less than a 2 log10 IU/mL decline from baseline in plasma HCV RNA levels after 12 weeks of previous interferon [IFN]-based therapy [pegylated or non-pegylated]) or relapsers (defined as a participant with undetectable plasma HCV RNA at the end of treatment of previous IFN-based therapy and subsequent confirmed detectable plasma HCV RNA levels during follow-up).|Day 7|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||log10 IU/mL||Standard Error|Mean
752583|NCT00561353|Secondary|Change From Baseline in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (log10 IU/mL) on Day 7 in Treatment-Naïve HCV-Infected Participants (Cohort 1 and 2, Panel B)|The table below shows the change from Baseline in plasma levels of HCV RNA on Day 7 (at Week 1) following treatment with TMC435 or placebo coadministered with ribavirin for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22 in treatment-naïve HCV-infected participants (A treatment-naive participant is someone who has never taken drugs for their HCV infection).|Day 7|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||log10 IU/mL||Standard Error|Mean
752584|NCT00561353|Secondary|Change From Baseline in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (log10 IU/mL) on Day 7 in Treatment-Naïve HCV-Infected Participants (Cohort 1 and 2, Panel A)|The table below shows the change from Baseline in plasma levels of HCV RNA on Day 7 (at Week 1) following treatment with TMC435 or placebo for 7 days followed by TMC435 or placebo coadministered with ribavirin for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22 in treatment-naïve HCV-infected participants. (A treatment-naive participant is someone who has never taken drugs for their HCV infection).|Day 7|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||log10 IU/mL||Standard Error|Mean
752585|NCT00561353|Primary|Change From Baseline in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (log10 IU/mL) at Week 4 in Treatment-Experienced HCV-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)|The table below shows the change from Baseline in plasma levels of HCV RNA at Week 4 following treatment with TMC435 or placebo coadministered with ribavirin for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22 in treatment-experienced participants considered non-responders (defined as participants who achieved less than a 2 log10 IU/mL decline from baseline in plasma HCV RNA levels after 12 weeks of previous interferon [IFN]-based therapy [pegylated or non-pegylated]) or relapsers (defined as a participant with undetectable plasma HCV RNA at the end of treatment of previous IFN-based therapy and subsequent confirmed detectable plasma HCV RNA levels during follow-up).|Week 4|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||log10 IU/mL||Standard Error|Mean
752631|NCT00561600|Secondary|Analysis of Metal Ion Release - Erythrocyte Chromium|Erythrocyte Chromium|12 months|Metal ion sub-study was limited to two sites. All participants with available data are presented below.||ug/L||Full Range|Median
766672|NCT00687674|Secondary|Change in Apoptosis Rate From Baseline to Post-treatment and Correlation With > Clinical Outcomes (Phase II)||Pre and Post treatment (up to 3 years)||||||
752586|NCT00561353|Primary|Change From Baseline in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (log10 IU/mL) at Week 4 in Treatment-Naïve HCV-Infected Participants (Cohort 1 and 2, Panel B)|The table below shows the change from Baseline in plasma levels of HCV RNA at Week 4 following treatment with TMC435 or placebo coadministered with ribavirin for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22 in treatment-naïve HCV-infected participants. (A treatment-naive participant is someone who has never taken drugs for their HCV infection).|Week 4|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||log10 IU/mL||Standard Error|Mean
752587|NCT00561353|Primary|Change From Baseline in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (log10 IU/mL) at Week 4 in Treatment-Naïve HCV-Infected Participants (Cohort 1 and 2, Panel A)|The table below shows the change from Baseline in plasma levels of HCV RNA at Week 4 following treatment with TMC435 or placebo as for 7 days followed by TMC435 or placebo coadministered with ribavirin for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22 in treatment-naïve HCV-infected participants. (A treatment-naive participant is someone who has never taken drugs for their HCV infection).|Week 4|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||log10 IU/mL||Standard Error|Mean
752588|NCT00561392|Secondary|Mean Change From Baseline in the Mini-Zarit Inventory Score of Caregiver Burden at Week 24|The Mini-Zarit Inventory assesses the burden of a caregiver in caring for a patient. The inventory is composed of 5 questions which are rated according to the following answers: 0 = never, ½ = sometimes, 1 = often. The ratings on the 5 questions are added together resulting in a total score of 0 to 7 with a higher score indicating greater caregiver burden. A negative change score indicates reduced burden.|Baseline to Week 24|The Intent-to-Treat (ITT) population was defined as all randomized patients who were administered at least one dose of study medication and were assessed at baseline and post-baseline for efficacy at least 1 time.||Units on a scale||Standard Deviation|Mean
752589|NCT00561392|Primary|Percentage of Participants Who Were Compliant to the 10 cm^2 Patch|"Dosages of study medication prescribed to and taken by the patient was assessed in a Drug Administration Record with start date, end date, dosage and reason for dose adjustment (if applicable). Data was amended by counting the returned medication at the study visits and information by the caregiver."|Baseline to Week 24|The Intent-to-Treat (ITT) population was defined as all randomized patients who were administered at least one dose of study medication and were assessed at baseline and post-baseline for efficacy at least 1 time.||Percentage of participants||Standard Deviation|Mean
752590|NCT00561392|Primary|Percentage of Participants Treated by Rivastigmine 10 cm^2 Patch for at Least 8 Weeks Regardless Whether They Completed the Study|"Dosages of study medication prescribed to and taken by the patient was assessed in a Drug Administration Record with start date, end date, dosage and reason for dose adjustment (if applicable). Data was amended by counting the returned medication at the study visits and information by the caregiver."|Baseline to Week 24|The Intent-to-Treat (ITT) population was defined as all randomized patients who were administered at least one dose of study medication and were assessed at baseline and post-baseline for efficacy at least 1 time.||Percentage of participants||95% Confidence Interval|Number
752591|NCT00561392|Secondary|Mean Change From Baseline in the Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (ADCS-CGIC) at Week 24 Assessed by the Caregiver|The ADCS-CGIC is an assessment tool to make a judgment of change in a patient’s condition. Change is derived from comparing an assessment performed at baseline versus an assessment at the end of the study. Change is categorized into 1 of 7 categories: No change; minimal, moderate, or marked improvement; or minimal, moderate, or marked decline.|Baseline t0 Week 24|The Intent-to-Treat (ITT) population was defined as all randomized patients who were administered at least one dose of study medication and were assessed at baseline and post-baseline for efficacy at least 1 time.||Participants|||Number
752592|NCT00561392|Secondary|Change From Baseline in the Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) at Week 24 Assessed by the Physician|The ADCS-CGIC is an assessment tool to make a judgment of change in a patient’s condition. Change is derived from comparing an assessment performed at baseline versus an assessment at the end of the study. Change is categorized into 1 of 7 categories: No change; minimal, moderate, or marked improvement; or minimal, moderate, or marked decline. Results are reported as number of patients in the indicated change category.|Baseline to Week 24|The Intent-to-Treat (ITT) population was defined as all randomized patients who were administered at least one dose of study medication and were assessed at baseline and post-baseline for efficacy at least 1 time.||Participants|||Number
752593|NCT00561392|Secondary|Mean Change From Baseline in the Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Score at Week 24|The ADCS-ADL scale is composed of 23 items developed to assess a patient's performance of both basic and instrumental activities of daily living such as those necessary for personal care, communicating and interacting with other people, maintaining a household, conducting hobbies and interests, as well as making judgments and decisions. Responses for each item will be obtained from the caregiver through an interview. The range for the total ADCS-ADL score is 0 to 78; a higher score indicates a more self-sufficient individual. A positive change score indicates improvement.|Baseline to Week 24|The Intent-to-Treat (ITT) population was defined as all patients who were administered at least one dose of study medication and were assessed for efficacy at least 1 time.||Units on a scale||Standard Deviation|Mean
752594|NCT00561392|Secondary|Mean Change From Baseline in the Trail-making Test Part A Score at Week 24|The Trail-making test is a neuropsychological test of visual attention and task switching. The task requires a subject to 'connect-the-dots' of 25 consecutive numbers (1,2,3, etc.) on a sheet of paper or computer screen. The goal of the subject is to finish the test as quickly as possible, and the time taken to complete the test is used as the primary performance metric (in seconds). The maximum time allowed is 300 seconds. A negative change score indicates improvement.|Baseline to Week 24|The Intent-to-Treat (ITT) population was defined as all randomized patients who were administered at least one dose of study medication and were assessed at baseline and post-baseline for efficacy at least 1 time.||Seconds||Standard Deviation|Mean
752632|NCT00561600|Secondary|Analysis of Metal Ion Release - Erythrocyte Cobalt|Erythrocyte Cobalt|12 Months|Metal ion sub-study was limited to two sites. All participants with available data are presented below.||ug/L||Full Range|Median
752595|NCT00561392|Secondary|Mean Change From Baseline in the Mini-Mental State Examination (MMSE) Score at Week 24|The MMSE is a brief, practical screening test for cognitive dysfunction. The test consists of five sections (orientation, registration, attention-calculation, recall, and language); the total score can range from 0 to 30, with a higher score indicating better function. A positive change score indicates improvement.|Baseline and Week 24|The Intent-to-Treat (ITT) population was defined as all randomized patients who were administered at least one dose of study medication and were assessed at baseline and post-baseline for efficacy at least 1 time.||Units on a scale||Standard Deviation|Mean
752596|NCT00561392|Primary|Percentage of Participants Treated by Rivastigmine 10 cm^2 Patch for at Least 8 Weeks Who Completed the Study|"Dosages of study medication prescribed to and taken by the patient was assessed in a Drug Administration Record with start date, end date, dosage and reason for dose adjustment (if applicable). Data was amended by counting the returned medication at the study visits and information by the caregiver."|Baseline to Week 24|The Intent-to-Treat (ITT) population was defined as all randomized patients who were administered at least one dose of study medication and were assessed at baseline and post-baseline for efficacy at least 1 time.||Percentage of participants||95% Confidence Interval|Number
752597|NCT00561418|Secondary|Time to Progression|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Up to 3 years|Unable to calculate time to progression for patients due to not enough follow up time|||||
752598|NCT00561418|Secondary|Duration of Response|Median follow up of living patients|Up to 5 years|||months||Full Range|Median
752599|NCT00561418|Secondary|Clinical Benefit|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 3 years|Response following AHSCT||patients|||Number
752600|NCT00561418|Primary|Safety and Tolerability of Vorinostat (SAHA) After Autologous Stem Cell Transplantation|NCI CTCAE version 3.0 was used to assess Adverse Events (AE) Grade 1=Mild AE Grade 2=Moderate AE Grade 3=Severe AE Grade 4=Life-threatening or disabling AE|Up to 3 years|||patients|||Number
752601|NCT00561431|Secondary|Recovery of Renal Function, Defined as Not Requiring Dialysis After Discontinuation of CRRT|The number of participants who recover renal function at 30 days after enrollment in each arm.|Up to 30 days|intention to treat||Participants|||Number
752602|NCT00561431|Primary|Number of Participants Alive at 30 Days After Enrollment Compared Between High Dose Versus Standard Dose Continuous Venovenous Hemodiafiltration (CVVHDF)|The primary objective is to determine whether Continuous Venovenous Hemodiafiltration (CVVHDF) using an effluent rate of 35 ml/hr/kg (high dose) leads to an increased participant survival time as compared to CVVHDF using the standard effluent rate of 25 ml/hr/kg as measured by days on continuous renal replacement therapy (CRRT) at enrollment up to 30 days.|Up to 30 days|Intention to treat||participants|||Number
752603|NCT00561457|Primary|Rate of Major Adverse Clinical Events (MACE)|Major Adverse Clinical Events defined as peri-procedural death (death during the procedure or prior to hospital discharge), target lesion revascularization (TLR), or stented segment restenosis (> 50%) at nine months postprocedure.|9-months|The analysis was an intention to treat (ITT)population which included the data for all completed patients (those who had a MACE event within 9-months and those who reached 9 months without experiencing an event). Natural censoring was used in the analysis according to the statistical analysis plan.||MACE events per 9 months||95% Confidence Interval|Mean
752604|NCT00561470|Secondary|Immunogenicity Assessment: Number of Participants With Positive Sample(s) in the Anti-drug Antibodies (ADA) Assay and in the Neutralizing Anti-drug Antibodies (NAb) Assay|Serum samples for immunogenicity assessment were analyzed using a bridging immunoassay to detect ADA. Positive samples in the ADA assay were further analyzed in the NAb assay using a validated, non-quantitative ligand binding assay.|Baseline, every other treatment cycle, 30 days and 90 days after the last infusion of aflibercept/placebo|Immunogenicity population included all participants who were treated and tested for immunogenicity at least once post-baseline.||participants|||Number
752605|NCT00561470|Secondary|Number of Participants With Adverse Events (AE)|"All AEs regardless of seriousness or relationship to study treatment, spanning from the first administration of study treatment until 30 days after the last administration of study treatment, were recorded, and followed until resolution or stabilization.
The number of participants with all treatment emergent adverse events (TEAE), serious adverse events (SAE), TEAE leading to death, and TEAE leading to permanent treatment discontinuation are reported."|From the date of the first randomization up to 30 days after the treatment discontinuation or until TEAE was resolved or stabilized|The safety population was the subset of the ITT population that took at least one dose of study treatment. Analyses was based on the treatment actually received (any participant who received at least one dose of aflibercept, even when receiving the rest of study treatment with placebo, was counted in the aflibercept treatment arm).||participants|||Number
752606|NCT00561470|Secondary|Overall Objective Response Rate (ORR) Based on the Tumor Assessment by the Independent Review Committee (IRC) as Per Response Evaluation Criteria in Solid Tumours (RECIST) Criteria|"The overall ORR was the percentage of evaluable participants who achieved complete response [CR] or partial response [PR] according to RECIST criteria version 1.0.
CR reflected the disappearance of all tumor lesions (with no new tumors)
PR reflected a pre-defined reduction in tumor burden
Tumors were assessed by the IRC using Computerized Tomography (CT) scans or Magnetic Resonance Imaging (MRI) scans; and an observed response was confirmed by repeated imaging after 4 – 6 weeks."|From the date of the first randomization until the study data cut-off date, 06 May 2010 (approximately 30 months)|The evaluable patient population (EPP) for tumor response included all randomized participants with measurable disease at study entry, as per IRC evaluation, and with at least one valid post-baseline tumor evaluation.||percentage of participants||95% Confidence Interval|Number
752633|NCT00561600|Secondary|Analysis of Metal Ion Release - Serum Chromium|Serum Chromium|12 Months|Metal ion sub-study was limited to two sites. All participants with available data are presented below.||ug/L||Full Range|Median
752634|NCT00561600|Secondary|Analysis of Metal Ion Release - Serum Cobalt|Serum Cobalt|12 months post-operative|Metal ion sub-study was limited to two sites. All participants with available data are presented below.||ug/L||Full Range|Median
752607|NCT00561470|Secondary|Progression-free Survival (PFS) Assessed by Independent Review Committee (IRC)|"PFS was the time interval from the date of randomization to the date of progression, or death from any cause if it occurs before tumor progression is documented. To evaluate disease progression, copies of all tumor imaging sets were systematically collected and assessed by the IRC.
PFS was analyzed using the Kaplan-Meier method, and the Hazard Ratio was estimated using the Cox Proportional Hazard Model.
The analysis for PFS was performed as planned when 561 deaths (OS events) had occurred."|From the date of the first randomization until the occurrence of 561 OS events, 06 May 2010 (approximately 30 months)|Intent to Treat (ITT) population included all participants who gave informed consent and were randomized.||months|Participants|Inter-Quartile Range|Median
752608|NCT00561470|Primary|Overall Survival (OS)|"Overall Survival was the time interval from the date of randomization to the date of death due to any cause. Once disease progression was documented, participants were followed every 2 months for survival status, until death or until the study cutoff date, whichever came first. The final data cutoff date for the analysis of OS was the date when 863 deaths had occurred (07 February 2011).
OS was estimated using the Kaplan-Meier method, and the Hazard Ratio was estimated using the Cox Proportional Hazard Model."|From the date of the first randomization until the study data cut-off date, 07 February 2011 (approximately three years)|Intent-to-treat population (ITT) – all participants who gave informed consent and were randomized.||months|Participants|Inter-Quartile Range|Median
752609|NCT00561574|Secondary|Change From Baseline in Number of Awakenings (NAW)|"NAW was defined as the time recorded by participants in response to Weekly Sleep Diary question 2a During the past 7 nights, how many times did you wake up, on average? Baseline was defined as the Day 1 assessment of Days -7 to 1 before any study drug was taken. Change from Baseline was calculated using a LOCF approach."|Baseline and Week 52|The ITT population consisted of all participants who received at least one dose of study drug and had at least one postbaseline NAW assessment.||Number of Awakenings||Standard Deviation|Mean
752610|NCT00561574|Secondary|Change From Baseline in Sleep Latency (SL)|"SL was defined as the time recorded by participants in response to Weekly Sleep Diary question 4 During the past 7 nights, how long did it take you to fall asleep, on average? Baseline was defined as the Day 1 assessment of Days -7 to 1 before any study drug was taken. Change from Baseline was calculated using a LOCF approach."|Baseline and Week 52|The ITT population consisted of all participants who received at least one dose of study drug and had at least one postbaseline SL assessment.||Minutes||Standard Deviation|Mean
752611|NCT00561574|Secondary|Change From Baseline in Wake Time After Sleep Onset (WASO)|"WASO was defined as the time recorded by participants in response to Weekly Sleep Diary question 4 During the past 7 nights, how much time were you awake, on average, after falling asleep initially? Baseline was defined as the Day 1 assessment of Days -7 to 1 before any study drug was taken. Change from Baseline was calculated using a LOCF approach."|Baseline and Week 52|The ITT population consisted of all participants who received at least one dose of study drug and had at least one postbaseline WASO assessment.||Minutes||Standard Deviation|Mean
752612|NCT00561574|Secondary|Change From Baseline in Total Sleep Time (TST)|"TST was defined as the time recorded by participants in response to Weekly Sleep Diary question 4 During the past 7 nights, how much time did you actually spend sleeping, on average?. Baseline was defined as the Day 1 assessment of Days -7 to 1 before any study drug was taken. Change from Baseline was calculated using a last observation carried forward (LOCF) approach."|Baseline and Week 52|The Intent-To-Treat (ITT) population consisted of all participants who received at least one dose of study drug and had at least one postbaseline TST assessment.||Minutes||Standard Deviation|Mean
752613|NCT00561574|Primary|Change From Baseline in Total Nap Time|"Total nap time was assessed by participants in response to Weekly Sleep Diary question 9a How much time per day did you nap, on average?. Baseline was defined as the Day 1 assessment of Days -7 to 1 before any study drug was taken. Change from Baseline was calculated using an OC approach."|Baseline and Week 52|The AST population consisted of all participants who received at least one dose of study drug.||Minutes||Standard Deviation|Mean
752614|NCT00561574|Primary|Change From Baseline in Ability to Work/Function|"Ability to work/function was assessed by participants using a 0-100 mm visual analog scale (VAS) in response to Weekly Sleep Diary question 8 How were you able to work or function over the past 7 days?. Scores could range from 0=Not at all to 100=Very well. Baseline was defined as the Day 1 assessment of Days -7 to 1 before any study drug was taken. Change from Baseline was calculated using an OC approach."|Baseline and Week 52|The AST population consisted of all participants who received at least one dose of study drug.||Score on a Scale||Standard Deviation|Mean
752615|NCT00561574|Primary|Change From Baseline in Feeling Full of Energy|"Feeling full of energy was assessed by participants using a 0-100 mm visual analog scale (VAS) in response to Weekly Sleep Diary question 7 How full of energy have you felt over the past 7 days?. Scores could range from 0=Terribly tired to 100=Full of energy. Baseline was defined as the Day 1 assessment of Days -7 to 1 before any study drug was taken. Change from Baseline was calculated using an OC approach."|Baseline and Week 52|The AST population consisted of all participants who received at least one dose of study drug.||Score on a Scale||Standard Deviation|Mean
752616|NCT00561574|Primary|Change From Baseline in Alertness at Awakening|"Alertness at awakening was assessed by participants using a 0-100 mm visual analog scale (VAS) in response to Weekly Sleep Diary question 6 How did you feel upon awakening over the past 7 days?. Scores could range from 0=Tired to 100=Alert. Baseline was defined as the Day 1 assessment of Days -7 to 1 before any study drug was taken. Change from Baseline was calculated using an observed cases (OC) approach."|Baseline and Week 52|The AST population consisted of all participants who received at least one dose of study drug.||Score on a Scale||Standard Deviation|Mean
752617|NCT00561574|Primary|Number of Participants Who Discontinue Study Drug Due to an AE|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not related to the study drug.|Up to 52 weeks|The AST population consisted of all participants who received at least one dose of study drug.||Participants|||Number
752618|NCT00561574|Primary|Number of Participants Who Experience at Least One Adverse Event (AE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not related to the study drug.|Up to 53 weeks|The All-Subjects-Treated (AST) population consisted of all participants who received at least one dose of study drug.||Participants|||Number
752646|NCT00561600|Primary|Composite Success Based Upon Harris Hip Score, Radiographic and Survivorship Outcomes|"Composite success: 1) Revision free (life of study) 2) No evidence of radiographic failure (life of study) 3) Harris Hip score => 80 at 24 months"|24-month interval.|Out of the 265 enrolled subjects, 51 subjects were removed from the analysis for the following reasons: 2 deaths (1 inv, 1 control); 4 protocol violations (0 inv, 4 control); 6 consent withdrawn (2 inv, 4 control); 39 lost to follow-up (17 inv, 22 control).||participants|||Number
752647|NCT00561652|Other Pre-specified|Participant Adherence With Week 26 Follow-up Questionnaire|Number of participants who completed week 26 follow-up questionnaire|26 weeks|||participants|||Number
752648|NCT00561652|Other Pre-specified|Participant Adherence With Week 12 Follow-up Questionnaire|Number of participants who completed their week 12 follow-up questionnaire|12 weeks|||participants|||Number
752649|NCT00561652|Other Pre-specified|Participant Adherence With Week 6 Follow-up Questionnaire|Number of participants who completed their week 6 follow-up questionnaire|6 weeks|||participants|||Number
752650|NCT00561652|Other Pre-specified|Participant Adherence With Prescribed Home Exercise|Number of participants who completed at least 20 hours of home exercise|12 weeks|||participants|||Number
752651|NCT00561652|Other Pre-specified|"Participant Adherence With Time and Attention Visits"|"Number of participants who completed at least 8 of 10 time and attention visits. Note that only arm 1 (nonchiropractic arm) receives time and attention visits."|12 weeks|"Only arm 1 received time and attention visits as their purpose was to balance the chiropractor provider contact time received by arm 2 participants."||participants|||Number
752652|NCT00561652|Primary|Participant Adherence With Education + Exercise Visits|Number of participants completing at least 3 of 4 education + exercise visits|12 weeks|||participants|||Number
752653|NCT00561652|Other Pre-specified|Participant Adherence With Chiropractic Visits|Number of participants who completed at least 12 chiropractic visits.|12 weeks|||participants|||Number
752654|NCT00561678|Secondary|Length of Stay|Length of Stay (LOS) in the hospital|average 4 days|||days||Inter-Quartile Range|Median
752655|NCT00561678|Secondary|Intraoperative Hypertension|Number of participants with intraoperative hypertension|day 1|||Participants|||Count of Participants
752656|NCT00561678|Secondary|Intraoperative Hypotension|Number of participants with intraoperative hypotension|day 1|||Participants|||Count of Participants
752657|NCT00561678|Secondary|Intraoperative Bradycardia|Number of participants with intraoperative bradycardia|day 1|||Participants|||Count of Participants
752658|NCT00561678|Secondary|Neuropsychological Testing|Rate of change of cognitive function - data not collected because secondary analysis which was not performed|at 3 months postoperatively||||||
752659|NCT00561678|Primary|Delirium Battery|Number of Participants with occurrence of Post-Operative Delirium in Post-Anesthesia Care Unit (PACU)|post surgery|||Participants|||Count of Participants
752660|NCT00561730|Secondary|Assessment of the Tolerability of Pantoprazole 20 mg/40 mg at Final Visit|Assessment on a scale: 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory|7 days|Patients included and treated with at least one application of pantoprazole (without imputation of missing values), intention to treat||Percentage of participants|||Number
752661|NCT00561730|Secondary|Assessment of the Efficacy of Pantoprazole 20 mg/40 mg at Final Visit|Assessment on a scale: 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory|7 days|Patients included and treated with at least one application of pantoprazole (without imputation of missing values), intention to treat||Percentage of participants|||Number
752662|NCT00561730|Secondary|Physician's Assessment of Painful Swallowing|Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe|7 days|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat||Units on a scale||Standard Deviation|Mean
752663|NCT00561730|Secondary|Physician's Assessment of Acid Eructation|Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe|7 days|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat||Units on a scale||Standard Deviation|Mean
752664|NCT00561730|Secondary|Physician's Assessment of Heartburn|Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe|7 days|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat||Units on a scale||Standard Deviation|Mean
752665|NCT00561730|Primary|Patient's Assessment of Sleep Disturbances During the Last 24 Hours (Diaries; ReQuest™ in Practice)|Assessment on a scale: Severity from 0=None to 10=Extremely strong|7 days|"All patients included and treated, intention to treat, missing values not imputed ('as observed').
Number of valid cases:
Day 0 = 1755
Day 1 = 1740
Day 2 = 1740
Day 3 = 1733
Day 4 = 1732
Day 5 = 1725
Day 6 = 1727"||Units on a scale||Standard Deviation|Mean
752666|NCT00561730|Primary|Patient's Assessment of Nausea During the Last 24 Hours (Diaries; ReQuest™ in Practice)|Assessment on a scale: Severity from 0=None to 10=Extremely strong|7 days|"All patients included and treated, intention to treat, missing values not imputed ('as observed').
Number of valid cases:
Day 0 = 1755
Day 1 = 1744
Day 2 = 1742
Day 3 = 1728
Day 4 = 1727
Day 5 = 1724
Day 6 = 1726"||Units on a scale||Standard Deviation|Mean
752667|NCT00561730|Primary|Patient's Assessment of Lower Abdominal/Digestive Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice)|Assessment on a scale: Severity from 0=None to 10=Extremely strong|7 days|"All patients included and treated, intention to treat, missing values not imputed ('as observed').
Number of valid cases:
Day 0 = 1754
Day 1 = 1742
Day 2 = 1739
Day 3 = 1733
Day 4 = 1730
Day 5 = 1726
Day 6 = 1729"||Units on a scale||Standard Deviation|Mean
752668|NCT00561730|Primary|Patient's Assessment of Upper Abdominal/Stomach Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice)|Assessment on a scale: Severity from 0=None to 10=Extremely strong|7 days|"All patients included and treated, intention to treat, missing values not imputed ('as observed').
Number of valid cases:
Day 0 = 1760
Day 1 = 1750
Day 2 = 1746
Day 3 = 1735
Day 4 = 1735
Day 5 = 1730
Day 6 = 1734"||Units on a scale||Standard Deviation|Mean
752669|NCT00561730|Primary|Patient's Assessment of Acid Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice)|Assessment on a scale: Severity from 0=None to 10=Extremely strong|7 days|"All patients included and treated, intention to treat, missing values not imputed ('as observed').
Number of valid cases:
Day 0 = 1767
Day 1 = 1758
Day 2 = 1757
Day 3 = 1744
Day 4 = 1743
Day 5 = 1739
Day 6 = 1739"||Units on a scale||Standard Deviation|Mean
755304|NCT00593606|Primary|Change in Glutamic Pyruvic Transaminase|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||Units/l||Standard Deviation|Mean
752670|NCT00561730|Primary|Patient's Assessment of General Well-being During the Last 24 Hours (Diaries; ReQuest™ in Practice)|Assessment on a scale: Severity from 0=Excellent to 10=Extremely bad|7 days|"All patients included and treated, intention to treat, missing values not imputed ('as observed').
Number of valid cases:
Day 0 = 1769
Day 1 = 1760
Day 2 = 1761
Day 3 = 1751
Day 4 = 1749
Day 5 = 1742
Day 6 = 1747"||Units on a scale||Standard Deviation|Mean
752671|NCT00561795|Primary|Number of Participants Experiencing Serious Adverse Events and Non-serious Adverse Events|"Safety and tolerability were measured by the number of participants with serious adverse events and non-serious adverse events. See the Adverse Event section of the results record for additional details and data."|Baseline to End of Study (up to a year)|||participants|||Number
752672|NCT00561795|Secondary|18-week Progression Free Survival|Defined as the number participants who have not had radiological disease progression per RECIST, confirmed CA-125 progression, or death due to any cause by the end of 18 weeks.|Baseline to Week 18|||participants|||Number
752673|NCT00561795|Secondary|Cancer Antigen (CA-125) Response|Defined as the number of participants who achieved a confirmed CA-125 response, which is defined as at least a 50% reduction in CA-125 levels from a pre-treatment sample.|Baseline until response (up to 2 years)|||participants|||Number
752674|NCT00561795|Secondary|Overall Response|Although the study protocol specified several efficacy analyses, due to poor tolerability of the combination regimen and the consequent early withdrawal of most participants, which led to a small sample size, efficacy analyses were not performed. Overall response is defined as the number of participants with CR or PR per Response Evaluation Criteria In Solid Tumors (RECIST): CR, all detectable tumor has disappeared; PR, a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum.|Baseline until either response or progression (up to 2 years)|||participants|||Number
752675|NCT00561821|Secondary|Number of Participants Who Discontinued Treatment Due to an Adverse Event During the 16 Day, Double-blind Treatment Period|An AE is any untoward occurrence in a participant who is administered any pharmaceutical product, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding) symptom, or disease temporarily associated with the use of an IMP, whether or not it is related to the IMP.|Up to Day 16|All participants who received at least one dose of study medication.||Number of participants|||Number
752676|NCT00561821|Secondary|Number of Participants With an Adverse Event During the 16 Day, Double-blind Treatment Period|An Adverse Event (AE) is any untoward occurrence in a participant who is administered any pharmaceutical product, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding) symptom, or disease temporarily associated with the use of an investigational medicinal product (IMP), whether or not it is related to the IMP.|Up to Day 16|All participants who received at least one dose of study medication.||Number of participants|||Number
752677|NCT00561821|Secondary|Average Subjective Satisfaction of Sleep Duration Based on Sleep Diary|Satisfaction of Sleep Duration (SSD) is a subjective number on a Visual Analog Scale ranging from 0 to 100, where very unsatisfied is rated at 0, up to fully satisfied, rated at 100. Daily recordings by the participant in an electronic diary (observed data only) were averaged over the entire 16-day, double-blind treatment period.|Up to Day 16|The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.||Units on a Scale||Standard Deviation|Mean
752678|NCT00561821|Secondary|Average Subjective Quality of Sleep Based on Sleep Diary|Quality of Sleep (QS) is a subjective number on a Visual Analog Scale ranging from 0 to 100, where very poor is rated at 0, up to excellent, rated at 100. Daily recordings by the participant in an electronic diary (observed data only) were averaged over the entire 16-day, double-blind treatment period.|Up to Day 16|The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.||Units on a Scale||Standard Deviation|Mean
752679|NCT00561821|Secondary|Average Subjective Wake Time After Sleep Onset Based on Sleep Diary|Wake Time after Sleep Onset (WASO) is after falling asleep initially, the subjective time that the participant was awake during the night. Daily recordings by the participant in an electronic diary (observed data only), were averaged over the entire 16-day, double-blind treatment period.|Up to Day 16|The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.||Minutes||Standard Deviation|Mean
752680|NCT00561821|Secondary|Average Subjective Number of Awakenings Based on Sleep Diary|Number of awakenings between sleep onset and final awakening (NAW) is a subjective number (observed data only) recorded daily by the participant in an electronic diary, that was averaged over the entire 16-day, double-blind treatment period.|Up to Day 16|The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.||Number of Awakenings||Standard Deviation|Mean
752681|NCT00561821|Secondary|Average Subjective Sleep Latency Based on Sleep Diary|Sleep latency (SL) is the time taken to fall asleep (observed data only) recorded daily by the participant in an electronic diary, that was averaged over the entire 16-day, double-blind treatment period.|Up to Day 16|The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.||Minutes||Standard Deviation|Mean
752682|NCT00561821|Secondary|Average Subjective Total Sleep Time Based on Sleep Diary|Total Sleep Time (TST) is a subjective time (observed data only) recorded daily by the participant in an electronic diary, that was averaged over the entire 16-day, double-blind treatment period.|Up to Day 16|The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.||Minutes||Standard Deviation|Mean
752683|NCT00561821|Secondary|Average Number of Stage Shifts to Stage 1 or Wake Measured by Polysomnography|Number of stage shifts to stage 1 of sleep or to awaken was measured by PSG. A stage shift is the transition measured by PSG between various sleep stages. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of the number of stage shifts (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged.|Up to Day 16|The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.||Number of stage shifts||Standard Deviation|Mean
752684|NCT00561821|Secondary|Average Wake Time After Sleep Onset in the Fourth Quarter of the Night Measured by Polysomnography|"Wake time after sleep onset (WASO) is the total time awake between sleep onset and lights on; i.e. from the onset of persistent sleep until the end of the 8-hour PSG recording. WASO was recorded in the fourth quarter of the night, for at most 2 hours, by PSG. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of WASO (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged."|Up to Day 16|The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.||Minutes||Standard Deviation|Mean
752685|NCT00561821|Secondary|Average Wake Time After Sleep Onset in the Third Quarter of the Night Measured by Polysomnography|"Wake time after sleep onset (WASO) is the total time awake between sleep onset and lights on; i.e. from the onset of persistent sleep until the end of the 8-hour PSG recording. WASO was recorded in the third quarter of the night, for at most 2 hours, by PSG. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of WASO (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged."|Up to Day 16|The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.||Minutes||Standard Deviation|Mean
752686|NCT00561821|Secondary|Average Wake Time After Sleep Onset in the Second Quarter of the Night Measured by Polysomnography|"Wake time after sleep onset (WASO) is the total time awake between sleep onset and lights on; i.e. from the onset of persistent sleep until the end of the 8-hour PSG recording. WASO was recorded in the second quarter of the night, for at most 2 hours, by PSG. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of WASO (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged."|Up to Day 16|The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.||Minutes||Standard Deviation|Mean
752687|NCT00561821|Secondary|Average Wake Time After Sleep Onset in the First Quarter of the Night Measured by Polysomnography|"Wake time after sleep onset (WASO) is the total time awake between sleep onset and lights on; i.e. from the onset of persistent sleep until the end of the 8-hour PSG recording. WASO was recorded in the first quarter of the night, for at most 2 hours, by PSG. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of WASO (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged."|Up to Day 16|The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.||Minutes||Standard Deviation|Mean
752688|NCT00561821|Secondary|Average Number of Awakenings Measured by Polysomnography|Number of awakenings (NAW) was measured by PSG. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of NAW (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged.|Up to Day 16|The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.||Number of awakenings||Standard Deviation|Mean
752689|NCT00561821|Secondary|Average Total Sleep Time Measured by Polysomnography|Total sleep time (TST) is the sleep time recorded by PSG. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of TST (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged.|Up to Day 16|The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.||Minutes||Standard Deviation|Mean
752690|NCT00561821|Secondary|Average Latency to Persistent Sleep Measured by Polysomnography|Latency to Persistent Sleep (LPS) is the time from lights out to the first 20 consecutive epochs scored as sleep by PSG. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of LPS (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged.|Up to Day 16|The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.||Minutes||Standard Deviation|Mean
752856|NCT00573131|Primary|Overall Tumor Response at the Primary Tumor Site Based on Measurement of Primary Tumor Volume (Excluding Involved Lymph Nodes) by Spiral CT||Screening and Week 12|Subjects who received at least one treatment with OncoGel, systemic chemotherapy or external beam radiation therapy were included for analysis of efficacy.||percentage of patients|||Number
752691|NCT00561821|Primary|Average Wake Time After Sleep Onset Measured by Polysomnography|"Wake time after sleep onset (WASO) is the total time awake between sleep onset and lights on; i.e. from the onset of persistent sleep until the end of the 8-hour polysomnography (PSG) recording. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of WASO (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged."|Up to Day 16|The intent to treat (ITT) population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.||Minutes||Standard Deviation|Mean
752692|NCT00570232|Secondary|Percentage of Participants Demonstrating Survival at 12 Months and 24 Months.|Percentage of participants who were still alive at 12 months following completion of study drug therapy and at 24 months following completion of study drug therapy|12 - 24 months|||percentage of participants|||Number
752693|NCT00570232|Primary|Percentage of Participants With Disease Free Status at 12 Months and 24 Months|Percentage of participants who were disease free at 12 months (12 months after initiation of study drug treatment) and 24 months (12 months after completion of study drug treatment)|12 - 24 months|||percentage of participants|||Number
752694|NCT00570232|Primary|Number of Participants Demonstrating the Safety and Tolerability of Long Term Erlotinib Treatment|Number of participants who had the most frequently observed undesirable effects after exposure to study drug|12 - 24 months|||participants|||Number
752695|NCT00570310|Secondary|'Time to Efficacy Failure' During the Randomized Withdrawal Portion of the Study|Time to treatment failure (3 day mean of average 24 hour pain intensity ≥ 4 with at least a 30% increase relative to the last 3 days prior to randomization)|6 Weeks|Primary Responders: ≥30% decrease in mean of average daily pain intensity during the last 3 days of the maintenance phase relative to baseline.||Days||Full Range|Least Squares Mean
752696|NCT00570310|Primary|Daily Evening Patient Reported Pain Intensity Scores|Change from mean of last 3 days of maintenance period to last 3 days of double-blind period; Pain Intensity was rated on a 0-10 numeric rating scale (NRS: 0=no pain, 10=worst pain you can imagine)|Baseline and 6 Weeks|Patients who had a ≥30% decrease in mean of average daily pain intensity during the last 3 days of the maintenance phase relative to baseline.||Units on a Scale||Full Range|Least Squares Mean
752697|NCT00570349|Primary|Change in Forced Expiratory Volume in 1 Second (FEV1)|Decrease in forced expiratory volume in 1 second was measured through spirometer. Spirometer measures the volume of air inspired and expired by the lungs.|Baseline and 48 hours|||Liters||Standard Deviation|Mean
752698|NCT00570349|Primary|Change in Oxygen Saturation|"Safety and tolerability of drug assessed by decreased oxygen saturation was measured through pulse oximeter, which measure the amount of oxygen in the blood.
Normal range percentage is 95 - 100%"|Baseline and 48 hours|||Percent of oxygen saturation||Standard Deviation|Mean
752699|NCT00570349|Secondary|Assess the Difference in Sputum Bacterial Density Before and After NO Inhalation. Assess the Difference in Lower Airway Inflammatory Measures Before and After NO Inhalation||44 hours||||||
752700|NCT00570349|Primary|Safety and Tolerability of Drug, Assessed by Change in Methemoglobin Levels|Methemoglobin level assessments were measured through blood draws - hematology. This test measures the amount of methemoglobin (a type of hemoglobin that is unable to transport oxygen to tissues) in blood. Normal methemoglobin percentage range 1% - 2%.|Baseline and 48 hours|||Percent of Methemoglobin Level||Standard Deviation|Mean
752701|NCT00570362|Primary|Total Glutathione Levels|Subjects were instructed to fast from midnight to 8 AM on the morning of the test. All blood samples were obtained by a qualified registered nurse in the morning, between 8 and 10 AM.|Once in the morning.|||nmol||Standard Deviation|Mean
752702|NCT00570401|Primary|Determine the Overall Objective Response|To determine the overall response rate in patients with acquired erlotinib hydrochloride- or gefitinibresistant advanced adenocarcinoma of the lung treated with dasatinib using the RECIST criteria. Response and progression will be evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee.22 Changes in only the largest diameter (uni-dimensional measurement) of the tumor lesions are used in the RECIST.|2 years|||participants|||Number
752703|NCT00570492|Secondary|Number of Participants With the Indicated Urinalysis Results for Urine Appearance (App.)/Clarity and Color|Participants were assessed for their urine appearance, which was categorized as clear (normal), cloudy (presence of crystals, blood cells, or bacteria), of turbid. Also, participants were categorized by the color of urine: straw, yellow (normal urine), and dark yellow (DY) (which may be the result of bile in the urine).|Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)|ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.||participants|||Number
752704|NCT00570492|Secondary|Number of Participants With the Indicated Urinalysis Results for Urine Occult Blood (OB) and the Urine Leukocyte Esterase Test (LET)|Occult blood (OB) is blood that cannot be seen without a microscope. Normal urine does not contain any red blood cells. Leukocyte esterase is an enzyme and is not found in normal urine. In the dipstick (qualitative) test, the level of OB and leukocyte esterase in urine samples was recorded as negative (Neg), small, moderate, large, trace, 1+ (slightly positive), 2+ (positive), and 3+ (high positive). Participants were categorized as negative or positive based on the absence or presence, respectively, of OB and urine leukocyte esterase.|Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)|ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.||participants|||Number
752705|NCT00570492|Secondary|Number of Participants With the Indicated Urinalysis Results for Urine Glucose, Urine Ketones, and Urine Proteins|Urine glucose, urine ketones, and urine proteins were measured in participants using a dipstick (qualitative) test at the indicated time points. In this dipstick test, the level of glucose, ketones, and protein in urine samples was recorded as negative (Neg), trace (tr), 1+, 2+, and 3+ (the plus sign increases with a higher level of glucose, ketones, or proteins in the urine: 1+=slightly positive, 2+=positive, 3+=high positive). Participants were categorized as negative or positive based on the absence or presence, respectively, of glucose, ketones, and proteins in the urine.|Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)|ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.||participants|||Number
752706|NCT00570492|Secondary|Number of Participants With the Indicated Urinalysis Results for Urine Bilirubin and Urine Nitrite|Bilirubin is a normal body by-product (bile), and nitrite is a by-product of bacterial growth. Participants were categorized as Negative (Neg.) or Positive (Pos.) based on the absence or presence, respectively, of urine bilirubin (UB) and urine nitrate.|Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)|ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.||participants|||Number
752707|NCT00570492|Secondary|Mean Values for Urine Specific Gravity|Specific gravity is a measure of the amount of material dissolved in the urine. Specific gravity is the ratio of the density (mass of a unit volume) of a substance to the density (mass of the same unit volume) of a reference substance. Normal urine has a specific gravity between 1.010 and 1.020.|Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)|ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.||ratio||Standard Deviation|Mean
752708|NCT00570492|Secondary|Mean Values for Urine pH|Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).|Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)|ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.||scores on a scale||Standard Deviation|Mean
752709|NCT00570492|Secondary|Mean Hematology Values for Red Blood Cells (RBCs)|RBCs was assessed in participants at the indicated time points.|Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)|ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.||Trillion (10^12) cells (Ti)/L||Standard Deviation|Mean
752710|NCT00570492|Secondary|Mean Values for Hematocrit|Hematocrit was assessed in participants at indicated the time points. Hematocrit is the percentage of blood volume (BV) that is occupied by red blood cells (RBCs).|Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)|ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.||Percentage of BV occupied by RBCs||Standard Deviation|Mean
752711|NCT00570492|Secondary|Mean Values for Hemoglobin|Hemoglobin was assessed in participants at the indicated time points.|Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)|ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.||g/L||Standard Deviation|Mean
752712|NCT00570492|Secondary|Mean Hematology Values for Basophil, Eosinophil, Lymphocyte, White Blood Cell (WBC), Monocyte, Segmented Neutrophil (Neu), and Platelet Counts|Participants in the study were evaluated for the following hematology laboratory parameters at the indicated time points: Basophil, Eosinophil, Lymphocyte, White Blood Cell (WBC), Monocyte, Segmented Neutrophil (Neu), and Platelet counts.|Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)|ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.||Giga (10^9) cells (Gi)/L||Standard Deviation|Mean
752713|NCT00570492|Secondary|Mean Values for the Laboratory Parameters of Glucose, Calcium, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN)|Participants in the study were evaluated for the following clinical laboratory parameters at the indicated time points: Glucose, Calcium, Potassium, Sodium, and Urea/BUN.|Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)|ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.||Millimoles (mmol)/L||Standard Deviation|Mean
752714|NCT00570492|Secondary|Mean Values for the Laboratory Parameters of Total Bilirubin and Creatinine|Participants in the study were evaluated for the following clinical laboratory parameters at the indicated time points: Total Bilirubin and Creatinine.|Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)|ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.||Micromoles (µmol)/L||Standard Deviation|Mean
752715|NCT00570492|Secondary|Mean Values for the Laboratory Parameters if Albumin and Total Protein|Participants in the study were evaluated for the following clinical laboratory parameters at the indicated time points: Albumin and Total Protein.|Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)|ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.||Grams per liter (g/L)||Standard Deviation|Mean
752716|NCT00570492|Secondary|Mean Values for the Laboratory Parameters of Alkaline (Alk) Phosphatase (P), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)|Participants in the study were evaluated for the following clinical laboratory parameters at the indicated time points: Alk P, ALT, and AST.|Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)|ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.||International Units per liter (IU/L)||Standard Deviation|Mean
752717|NCT00570492|Secondary|Number of Participants With the Indicated Shifts From Baseline in Nasal Examination (NE) Results|NE included the evaluation of the size of ulcers/polyps (of nasal turbinates/septa) and assessment for mucosal bleeding (MB) at all study visits. Polyps are non-cancerous growths; ulcers are breaks in the skin/mucous membrane with loss of surface tissue, disintegration, and necrosis of epithelial tissue. For MB, Improved=shift from present (>=1 nostril) to absent (both nostrils); Worsened=shift from absent (both nostrils) to present (>=1 nostril). For polyps/ulcers, Improved=shift from large to small or from small to none; Worsened=shift from none to small or from small to none (>=1 nostril).|Baseline Period (Weeks -16 to 0) and DB Treatment Period (Weeks 1 to 52)|Intent-to-Treat (ITT) Population: all participants who had been randomized to and received at least one dose of double-blind study medication. Most participants received examinations at each visit; however, on some occasions, some assessments were not completed for various reasons.||participants|||Number
752718|NCT00570492|Secondary|Mean 24-hour Urinary Free Cortisol Excretion|Hypothalamic-pitiutary-adrenal (HPA) axis function was assessed by the measurement of urinary free cortisol, using urine samples collected over the course of 24 hours by the parent/guardian in the participants' home on an out-patient basis within 7 days prior to the indicated time points. Detailed verbal instructions and a take-home instruction card on how to conduct the 24-hour urine collection were provided to the parent/guardian before each collection interval.|Randomization/end of 16-week Baseline Period (Week 0), End of 52-week DB Treatment Period (Week 52), and end of 8-week Follow-up Period (Week 60)|Urine Cortisol Population: all randomized participants excluding those whose urine samples were considered to have confounding factors affecting the interpretation of the 24-hour urinary cortisol results. One participant in each arm had a Baseline value <1.0 and was not analyzed. Some participants had samples that were not acceptable for analysis.||Micrograms per 24 hours (mcg/24 hours)||Standard Deviation|Mean
752719|NCT00570492|Primary|Change From Baseline in the Growth Velocity of Pre-pubescent Pediatric Participants to the End of the 52-week Double-blind (DB) Treatment Period|Height was measured (triplicate measurements) in pre-pubescent pediatric participants via stadiometry at each clinic visit during the entire 76-week study period (16-week Baseline Period, 52-week DB Treatment Period and 8-week Follow-up Period). Growth velocity was calculated by fitting a regression line to all height measurements recorded for the participant during the period and was determined by the slope of the fitted regression line. Change from Baseline was calculated as the value over the 52-week Treatment Period minus the value over the 16-week Baseline Period.|Baseline Period (Weeks -16 to 0) and DB Treatment Period (Weeks 1 to 52)|Growth Population: all randomized participants with height assessments via stadiometry from at least three post-randomization clinic visits during the DB Treatment Period||Centimeters per year (cm/year)||Standard Error|Least Squares Mean
752720|NCT00570505|Post-Hoc|Change in Quality of Life (5 Years)|Change in quality of life was assessed using the Impact of Weight on Quality of Life-Lite (IWQOL-Lite) Total Score, which ranges from 0 (worst) to 100 (best). The mean change from baseline to 5 years in IWQOL-Lite Total Score is reported.|5 years|Intent-to-treat (ITT)||units on a scale||Standard Deviation|Mean
752721|NCT00570505|Post-Hoc|Change in Obesity Related Comorbid Conditions (5 Years)|Percent of subjects whose baseline comorbid condition of Type 2 diabetes, dyslipidemia, and hypertension resolved 5 years post LAP-BAND implantation. Diabetes resolution was defined as HbA1c ≤ 6% and no diabetes medication usage. Dyslipidemia resolution was defined as HDL ≥ 60 mg/dL, LDL < 100 mg/dL, triglycerides < 150 mg/dL, and total cholesterol < 200 mg/dL. Hypertension resolution was defined as systolic blood pressure < 140 mm Hg.|5 years|Subjects who had the specific comorbid condition at screening (Type 2 Diabetes n=5, Dyslipidemia n=45, Hypertension n=49)||percentage of subjects|||Number
752722|NCT00570505|Post-Hoc|Subject Percent Excess Weight Loss (5 Years)|The mean percent excess weight loss (%EWL) for subjects at month 60. Percent EWL = (weight loss divided by excess weight)*100.|5 years|Intent-to-treat (ITT)||percentage of excess weight loss||Standard Deviation|Mean
752723|NCT00570505|Post-Hoc|Percent of Subjects Attaining Clinically Successful Weight Loss ( ≥ 30% EWL) at 5 Years Post LAP-BAND Implantation|The percent of subjects who attained clinically successful weight loss (ie, ≥ 30% Excess Weight Loss) at year 5 post LAP-BAND implantation. Percent EWL =(weight loss divided by excess weight)*100. Excess Weight was defined as Baseline Weight - Ideal Weight, where Ideal Weight was a BMI of 25 kg/m2.|5 years|Intent-to-treat (ITT)||percentage of subjects||95% Confidence Interval|Number
752724|NCT00570505|Secondary|Change in Quality of Life|Change in quality of life was assessed using the Impact of Weight on Quality of Life-Lite (IWQOL-Lite) Total Score, which ranges from 0 (worst) to 100 (best). The mean change from baseline to 12 months in IWQOL-Lite Total Score is reported.|12 months|Intent-to-treat (ITT)||units on a scale||Standard Deviation|Mean
752725|NCT00570505|Secondary|Change in Comorbid Conditions Related to Obesity|"Percent of subjects whose baseline comorbid condition of Type 2 diabetes, dyslipidemia, and hypertension resolved (i.e., was rated as none on a severity scale of none, mild, moderate, or severe) 12 months after implantation."|12 months|Subjects who had the specific comorbid condition at baseline (Diabetes n = 6, Dyslipidemia n = 29, Hypertension n = 27)||percentage of subjects|||Number
752726|NCT00570505|Secondary|Percent Weight Loss|Percent weight loss was defined as weight loss divided by baseline weight, multiplied by 100. Weight loss was equal to baseline weight minus the follow-up visit weight. Excess weight = baseline weight minus ideal weight, where ideal weight was determined based on a BMI of 25 kg/m2.|Baseline through 12 months|Intent-to-treat (ITT)||percentage of weight loss||Standard Deviation|Mean
752727|NCT00570505|Primary|Percent of Subjects Attaining Clinically Successful Weight Loss ( ≥ 30% EWL) at 1 Year Post LAP-BAND Implantation|The percent of subjects attaining clinically successful weight loss at 1 year post LAP-BAND implantation. Clinically successful weight loss was defined as ≥ 30% Excess Weight Loss (%EWL), where %EWL was weight loss divided by excess weight multiplied by 100.|One year|Intent-to-treat (ITT)||percentage of subjects|||Number
752728|NCT00571103|Primary|The Primary Efficacy Measure Was the Yale-Brown Obsessive Compulsive Scale Modified for PG (YBOCS-PG).|The YBOCS-PG (Yale Brown Obsessive Compulsive Scale modified for Pathological Gambling) is used to assess the range and severity of PG symptoms. The scale is a modification of the YBOCS originally developed by Goodman et al. (1989) for use in rating severity and change in subjects with Obsessive Compulsive Disorder. This adaptation is a 10-item clinician-rated questionnaire, which rates (on a 5-point scale from 0 to 4) time spent, distress, interference, resistance, and control in relation to PG urges and behaviors. The scale ranges from 0 to 40 with a higher score representing increased severity in PG.|8 weeks minus baseline|||units on a scale||Standard Error|Mean
752741|NCT00571428|Secondary|Change in Percent of Predicted Forced Expiratory Volume at One Second (FEV1) at Each Assessed Time Point Post-Dose Compared to Pre-Dose|Predicted FEV1 is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. This outcome uses actual FEV1 readings to generate the change in percent of the estimated healthy lung function at specified time points compared to the pre-dose value.|Immediately post first dose, 30 min, 1,2,4,6,8,10,12,12.5,13,14,16,23,24 hours post first dose|Intent to treat population||percent of predicted FEV1||Standard Deviation|Mean
753260|NCT00567255|Secondary|Change in Fasting HDL Cholesterol Levels||Baseline, 28 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||mg/dL||Standard Error|Least Squares Mean
752729|NCT00571103|Secondary|The Secondary Efficacy Evaluations Will Include the G-SAS (Gambling Symptom Assessment Scale), Clinical Global Impression – Improvement Scale (CGI-I) , and the CGI-S Clinical Global Impression – Severity Scale.|The G-SAS is a 12 item self-report instrument that reflects the subjects urges to gamble and the subjects gambling behavior. Each item is scored on a 5-point scale from 0 (no symptoms) to 4 (extreme symptoms) with a total score range from 0 to 48. The CGI-I is a 7 point scale requiring the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. The CGI-S is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment. A patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; and 7, among the most extremely ill patients.|8 weeks minus baseline|A total of 39 participants were screened by phone and 5 failed to meet screening criteria and were excluded; 6 did not return for the baseline visit because of follow-up loss or choosing to discontinue participation. of the remaining 28 patients, 1 discontinued and another was lost to follow-up after the baseline visit. That left 26 subjects.||units on a scale||Standard Error|Mean
752730|NCT00571194|Primary|Pharmacokinetics||24 hours|Data was not collected|||||
752735|NCT00571428|Secondary|Change in Forced Vital Capacity From Pre-dose to Each Post-Dose Assessed Time Point|Forced vital capacity is the total amount of air that can forcibly be blown out after full inspiration. The measure compares the change from pre-dose reading to each post-dose time point.|immediately post first dose, 30 min, 1,2,4,6,8,10,12, 12.5, 13, 14, 16, 23,24 hours post first dose|Intent to treat population||liters||Standard Deviation|Mean
752736|NCT00571428|Secondary|Time to Onset of Response of Both a 12 Percent Increase and 200 Milliliter Increase in Forced Expiratory Volume in One Second Within 12 Hours of Dosing|Forced vital capacity is the total amount of air that can forcibly be blown out after full inspiration.|pre-dose, immediately post first dose, 30 min, 1,2,4,6,8,10,12, 12.5, 13, 14, 16, 23,24 hours post first dose|Intent to treat population||minutes||Standard Deviation|Mean
752737|NCT00571428|Secondary|Time to Onset of Response of Both a 12 Percent Increase and 200 Milliliter Increase Within 12 Hours of Dosing|Time to a 12 percent improvement in forced expiratory volume in one second (FEV1) AND a 200 milliliter increase in FEV1 within 12 hours of dosing. Only patients who met both conditions are included|up to 12 hours post dose|Intent to treat population. Limited to patients who met both criteria: a 12 percent increase in FEV1 and a 200 milliliter increase in FEV1||minutes||Full Range|Median
752738|NCT00571428|Secondary|Time to Onset of 15 Percent Response Within 12 Hours of Dosing|Time to a 15 percent improvement in forced expiratory volume in one second (FEV1) within 12 hours of dosing. Only patients who achieved at least a 15 percent improvement are included.|12 hours post first dose|Intent to treat population. Limited to those patients who had a 15% response.||minutes||Full Range|Median
752739|NCT00571428|Secondary|Peak Change in Forced Expiratory Volume at One Second (FEV1) Within 12 Hours Post Dose Compared to Pre-dose|Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change in FEV1 from pre-dose to the readings taken 12 hours post-dose, and reports the largest change during that time.|12 hours|||liters||Standard Deviation|Mean
752740|NCT00571428|Secondary|Peak Percent of Predicted Forced Expiratory Volume at One Second (FEV1) Over 12 Hours Post-Dose.|Predicted FEV1 is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. This outcome uses actual FEV1 readings to generate the percent of the estimated healthy lung function and reports the highest percent found within 12 hours of dosing.|12 hours|Intent to treat population||percent of predicted FEV1||Standard Deviation|Mean
752742|NCT00571428|Secondary|Percent of Predicted Forced Expiratory Volume at One Second at Pre-dose and Each Assessed Time Point Post-Dose|Predicted FEV1 is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. This outcome uses actual FEV1 readings to generate the percent of the estimated healthy lung function at specified time points.|Pre-dose, Immediately post first dose, 30 min, 1,2,4,6,8,10,12,12.5,13,14,16,23,24 hours post first dose|Intent to treat population||Percent of Predicted FEV1||Standard Deviation|Mean
752743|NCT00571428|Secondary|Change in Forced Expiratory Volume in One Second From Pre-dose To Each Assessed Time Point Post-Dose|Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome offers the change in FEV1 readings between pre-dose and various time points within 24 hours post-dose.|Immediately post first dose, 30 min, 1,2,4,6,8,10,12,12.5,13,14,16,23,24 hours post first dose|Intent to treat population||liters||Standard Deviation|Mean
752744|NCT00571428|Secondary|Forced Expiratory Volume in One Second Measurements Pre-dose and at Each Assessed Time Point Post-dose|Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome offers the FEV1 readings taken pre-dose and at various time points within 24 hours post-dose.|pre-dose, immediately post-dose, 30 min, 1,2,4,6,8,10,12, 12.5,13,14,16,23,24 hours post first dose|Intent to treat population||liters||Standard Deviation|Mean
752745|NCT00571428|Secondary|Change in Forced Expiratory Volume in One Second From Pre-dose to the 24 Hour Time Point|Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change in FEV1 from pre-dose to the readings taken 24 hours post-dose, which represents the trough in dose level.|pre-dose and 24 hours post-dose|Intent to treat population||liters||Standard Deviation|Mean
752746|NCT00571428|Secondary|Time-Normalized Area Under the Change From Pre-Dose Curve for Forced Expiratory Volume in One Second Measured Between 12-24 Hours|Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change from pre-dose for a series of FEV1 readings taken between 12 and 24 hours of dosing.|12-24 hours|Intent to treat population||liters||Standard Deviation|Mean
752747|NCT00571428|Secondary|Time-Normalized Area Under the Change From Pre-Dose Curve for Forced Expiratory Volume in One Second Measured Over 12 Hours|Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change from pre-dose for a series of FEV1 readings taken within 12 hours of dosing.|0-12 hours|Intent to treat population||liters||Standard Deviation|Mean
752748|NCT00571428|Primary|Time-Normalized Area Under the Change From Pre-Dose Curve for Forced Expiratory Volume in One Second Measured Over 24 Hours|Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change from pre-dose for a series of FEV1 readings taken within 24 hours of dosing.|0-24 hours post dose|Intent to treat population||liters||Standard Deviation|Mean
752749|NCT00571649|Secondary|Percentage of Participants With the Composite of Treatment Emergent Major Bleeding Events and Non-major Clinically Relevant Bleeding Events up to 2 Days After Last Application of a Study Medication Syringe (Day 10 + 5 Days)|Major bleeding events were defined as events leading to >=2 g/dL fall in hemoglobin or transfusion of >=2 units of packed RBCs or whole blood or leading to death. Non-major bleeding events were defined as overt bleeding not meeting the criteria of major bleeding.|Up to Day 10 + 5 days|Safety population: Participant had at least one dose of study drug.||Percentage of participants|||Number
752750|NCT00571649|Secondary|Percentage of Participants With the Composite of Treatment Emergent Major Bleeding Events and Non-major Clinically Relevant Bleeding Events up to 2 Days After Last Intake of Any Study Medication (Day 35 + 6 Days)|Major bleeding events were defined as events leading to >=2 g/dL fall in hemoglobin; or transfusion of >= 2 units of packed RBCs (Red blood cells) or whole blood; or leading to death. Non-major bleeding events were defined as overt bleeding not meeting the criteria of major bleeding|Up to Day 35 + 6 days|Safety population: Participant had at least one dose of study drug.||Percentage of participants|||Number
752751|NCT00571649|Secondary|Percentage of Participants With All-cause Mortality up to Day 90 + 7 Days|All deaths, including VTE-related deaths, cardiovascular deaths, and other deaths.|Up to Day 90 + 7 days|Safety population: Participant had at least one dose of study drug.||Percentage of participants|||Number
752752|NCT00571649|Secondary|Percentage of Participants With Each Component of the Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 10 + 5 Days|The components of the composite endpoint include asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death.|Up to Day 10 + 5 days|Per Protocol Day 10: participant was valid for the safety analysis, had an adequate assessment of VTE up to Day 10 not later than 48 hours after stop of study drug, met inclusion criteria, and had no major protocol deviations||Percentage of participants|||Number
752753|NCT00571649|Secondary|Percentage of Participants With Each Component of the Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 35 + 6 Days|The components of the composite endpoint include asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death.|Up to Day 35 + 6 days|modified Intent-to-Treat (mITT) Day 35: participant was valid for the safety analysis and had an adequate assessment of VTE up to Day 35||Percentage of participants|||Number
752754|NCT00571649|Secondary|Percentage of Participants With Major Vascular Events up to Days 10, 35, and 90|Major vascular events included cardiovascular death, acute myocardial infarction (MI), or acute ischemic stroke. Participants may have had a vascular event in more than one category.|At Day 10 + 5 days, at Day 35 + 6 days, and at Day 90 + 7 days|Safety population: Participant had at least one dose of study drug.||Percentage of participants|||Number
752796|NCT00572156|Secondary|Changes From Baseline (Day 1) in Serum Concentrations of Insulin-Like Growth Factor Binding Protein-1 (IGFBP-1)||At Baseline (Day 1), Year 1,2,3 and 4|Modified Intent-to-Treat (MITT) Population comprised all subjects who were randomized and had at least one post-baseline height measurement.||ng/mL||Standard Deviation|Mean
754802|NCT00586469|Secondary|Number of Participants Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling.|During the 4-day follow up period following vaccination.|Analysis was performed on the Total Vaccinated cohort.||participants|||Number
752755|NCT00571649|Secondary|Percentage of Participants With Net Clinical Benefit (Any DVT, Non-fatal PE, VTE-related Death, Plus Major and Clinically Relevant Non-major Bleeding Events) up to Day 10 + 5 Days|Net clinical benefit is a composite of the primary efficacy endpoint (asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death) plus major and clinically relevant non-major bleeding events|Up to Day 10 + 5 days|Participants valid for safety analysis, with adequate assessment of VTE (to Day 10 within 48 hours of study drug), met inclusion criteria, and no major protocol deviations; expanded to include participants who had major bleeding or clinically relevant non-major bleeding events and met all criteria for PP except valid assessment of thromboembolism.||Percentage of participants|||Number
752756|NCT00571649|Secondary|Percentage of Participants With Net Clinical Benefit (Any DVT, Non-fatal PE, VTE-related Death, Plus Major and Clinically Relevant Non-major Bleeding Events) up to Day 35 + 6 Days|Net clinical benefit is a composite of the primary efficacy endpoint (asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death) plus major and clinically relevant non-major bleeding events.|Up to Day 35 + 6 days|modified Intent-to-Treat (mITT) Day 35 (participant was valid for the safety analysis and had an adequate assessment of VTE up to Day 35) expanded to include participants with major and clinically relevant bleeding events.||Percentage of participants|||Number
752757|NCT00571649|Secondary|Percentage of Participants With Symptomatic VTE, Including and Excluding VTE-related Death up to Days 10, 35, and 90|Symptomatic VTE (non-fatal PE and DVT in lower extremity), including and excluding VTE-related death (PE and PE cannot be excluded) up to Days 10, 35, and 90|At Day 10 + 5 days, at Day 35 + 6 days, and at Day 90 + 7 days|Safety population: Participant had at least one dose of study drug.||Percentage of participants|||Number
752758|NCT00571649|Secondary|Percentage of Participants With VTE Combined With All-cause Mortality up to Day 10 + 5 Days|A composite endpoint of: asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and death (VTE-related and not VTE-related).|Up to Day 10 + 5 days|modified Intent-to-Treat (mITT) Day 10 (participant was valid for the safety analysis and had an adequate assessment of VTE up to Day 10) expanded to include participants who had an assessment of all deaths, including not VTE-related||Percentage of participants|||Number
752759|NCT00571649|Secondary|Percentage of Participants With Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 10 + 5 Days Per mITT Population|A composite endpoint of: asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death.|Up to Day 10 + 5 days|modified Intent-to-Treat (mITT) Day 10: participant was valid for the safety analysis and had an adequate assessment of VTE up to Day 10||Percentage of participants|||Number
752760|NCT00571649|Secondary|Percentage of Participants With Composite Endpoint of VTE (Any DVT, Non Fatal PE) and All-cause Mortality up to Day 35 + 6 Days|A composite endpoint of: asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and death (VTE-related and not VTE-related).|Up to Day 35 + 6 days|modified Intent-to-Treat (mITT) Day 35 (participant was valid for the safety analysis and had an adequate assessment of VTE up to Day 35) expanded to include participants who had an assessment of all deaths, including not VTE-related||Percentage of participants|||Number
752761|NCT00571649|Primary|Percentage of Participants With Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 10 + 5 Days|A composite endpoint of: asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death.|Up to Day 10 + 5 days|Per Protocol (PP) Day 10: participant was valid for the safety analysis, had an adequate assessment of VTE up to Day 10 not later than 48 hours after stop of study drug, met inclusion criteria, and had no major protocol deviations.||Percentage of participants|||Number
752762|NCT00571649|Primary|Percentage of Participants With Composite Endpoint of Venous Thromboembolism [VTE] (Any Deep Vein Thrombosis [DVT], Non Fatal Pulmonary Embolism [PE]) and VTE-related Death up to Day 35 + 6 Days|A composite endpoint of: asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death.|Up to Day 35 + 6 days|modified Intent-to-Treat (mITT) Day 35: participant was valid for the safety analysis and had an adequate assessment of VTE up to Day 35||Percentage of participants|||Number
752763|NCT00571662|Secondary|Responses to Therapy|event-free and overall survival at 12 months|every 6 mo. up to 2 years|||Percent of Participants|||Number
752764|NCT00571662|Secondary|Incidence of Acute and Chronic Graft-versus-host Disease|Incidence of acute and chronic graft-versus-host disease.Acute GVHD usually occurs during the first three months following transplant. Chronic GVHD usually develops after the third month post-transplant.|twice weekly until day 100 up to 1 year post transplant|||Percent of Particpants|||Number
752765|NCT00571662|Secondary|Immune Effects|kinetics of hematologic and immunologic reconstitution after allogeneic transplantation|pretransplant and post transplant days28,70,100 and 12, and 24 months||||||
752766|NCT00571662|Secondary|Toxicity|determination of regimen related toxicity of the combination of Pentostatin and low dose total body irradiation. Treatment related toxicity will be graded using NCI CTC Version 2.0 and GVHD using the standard GVHD grading system.|Duration of treatment||||||
752767|NCT00571662|Primary|Percent of Participants With Chimerism: Full Donor Chimerism Defined as >95% Donor CD3+ Cell in Blood as Assessed by DNA Fingerprinting|the efficacy of the regimen as determined by engraftment rate and establishment of donor hematopoietic chimerism at day +28 and day +70.|days +28 and +70|||percent of participants||Full Range|Median
752797|NCT00572156|Secondary|Changes From Baseline (Day 1) in Serum Concentrations of Insulin-Like Growth Factor-1 (IGF-1)||At Baseline (Day 1), Year 1,2,3 and 4|Modified Intent-to-Treat (MITT) Population comprised all subjects who were randomized and had at least one post-baseline height measurement.||ng/mL||Standard Deviation|Mean
766673|NCT00687674|Secondary|Changes in Microvessel Density From Baseline to Post-treatment and Correlation With > Clinical Outcomes (Phase II)||Pre and Post treatment (up to 3 years)||||||
752768|NCT00571688|Primary|Number of Relapse-related Events Normalized to Unit Time|The outcome was total number of events divided by number of months (normalized to unit time). This was be calculated by dividing the number of relapse related events by the number of months of participation. Relapse related events included: (1) YMRS score > 14 or MADRS > 15; (2) 20% or greater increase in the YMRS or MADRS scores from the previous study visit; (3) urgent care visit (psychiatric hospitalization; emergency department visit; referral for respite care, partial hospitalization, or intensive outpatient treatment) due to worsening mood symptoms; (4) a Clinical Global Impression Severity of Illness score >3; (5) syndromal relapse (Diagnostic and Statistical Manual of Mental Disorders, 4th Editionfor manic, hypomanic, major depressive, or mixed episode met); (6) withdrawal from the study due to inefficacy; and (7) necessary clinical medication adjustments (NCAs).|12 months|All randomized participants were analyzed.||Events/month||Standard Deviation|Mean
752769|NCT00571701|Secondary|Maintenance of Response Following Discontinuation of Celecoxib|Percent of patients who responded to celecoxib with increase in papilloma growth rate of no greater than 0.01 at end of second treatment period compared to growth rate at end of first treatment period.|End of first treatment period (month 12) to end of second treatment period (month 24)|All patients with complete response to celecoxib in first treatment period who completed the second treatment period where they received placebo. Because the number of responders was so small, no statistical analysis was performed.||percent of patients|||Number
752770|NCT00571701|Secondary|Correlation Between Mean Plasma Level of Celecoxib and Response.|Mean plasma levels of celecoxib over months 3-12 in first treatment period correlated with reduction in papilloma growth rate greater than 50% during the last 3 months of first treatment period compared to baseline.|Baseline to 12 months|All patients who were randomized to receive celecoxib first and completed the first treatment period. This is not a traditional cross-over study because we expected a sustained effect therefore no efficacy studies were done in segment C.||pg. celecoxib/ml. plasma||Full Range|Mean
752771|NCT00571701|Secondary|Effect of HPV 6 Versus HPV 11 on Percent of Patients With Reduction in Papilloma Growth Rate Greater Than 50%|Percent of patients with HPV 6 versus patients with HPV 11 with reduction in papilloma growth rate greater than 50% during the last 3 months of first treatment period compared to baseline.|Baseline to 12 months|Analysis conducted on all patients with HPV 6 or 11 infection who completed first treatment period. One patient with both HPV 6 and 11 and one patient with neither 6 or 11 were excluded. This is not a traditional cross-over study because we expected a sustained effect therefore no efficacy studies were done in segment C.||percent of responders|||Number
752772|NCT00571701|Secondary|Effect of Juvenile Versus Adult Disease Onset on Percent of Patients With Reduction in Papilloma Growth Rate Greater Than 50%.|Percent of juvenile versus adult onset patients with reduction in papilloma growth rate greater than 50% during the last 3 months of first treatment period compared to baseline.|Baseline to 12 months|Analysis conducted on all patients who completed first treatment period. Juvenile onset is defined as <18 years of age at time of diagnosis. Age of disease onset for 2 patients was not available. This is not a traditional cross-over study because we expected a sustained effect therefore no efficacy studies were done in segment C.||percentage of responders|||Number
752773|NCT00571701|Secondary|Effect of Gender on Percent of Patients With Reduction in Papilloma Growth Rate Greater Than 50%.|Percent of patients of each gender with reduction in papilloma growth rate greater than 50% during the last 3 months of first treatment period compared to baseline|Baseline to12 months|All patients who completed first treatment period. This is not a traditional cross-over study because we expected a sustained effect therefore no efficacy studies were done in segment C.||percent responders|||Number
752774|NCT00571701|Secondary|Percent of Patients With Positive Response to Treatment|Percent of patients with reduction in papilloma growth rate greater than 50% during the last 3 months of first treatment period compared to baseline|Baseline to 12 months|All patients that completed first treatment period. This is not a traditional cross-over study because we expected a sustained effect therefore no efficacy studies were done in segment C.||percent responders|||Number
752775|NCT00571701|Primary|Mean Percent Change in Papilloma Growth Rate at 12 Month Measurement Compared to Baseline|Change in mean growth rates during the last 3 months of the first treatment period compared to the mean values at baseline. Endoscopy and removal of all tumor was done every 3 months. Growth rate is calculated as the scored amount of papilloma recurrence in a 3 month period divided by the exact number of days since last endoscopy and removal of all tumor.|Baseline to 12 months|All patients in each arm who completed the first 1 year treatment period. This is not a traditional cross-over study because we expected a sustained effect therefore no efficacy studies were done in segment C.||percent change in mean growth rate||Standard Deviation|Mean
752776|NCT00571922|Secondary|Craving||7 day|PI passed away, data is unavailable|||||
752777|NCT00571922|Primary|Methamphetamine Abstinence||7 day|PI passed away, data is unavailable.|||||
752778|NCT00571948|Primary|Parameters of Iron Status in Blood||at the end of the fourth, seventh, tenth month of life||||||
752779|NCT00571948|Secondary|Dietary Intake; Anthropometric Measures: Body Weight, Body Lengths, Head Circumferences||dietary intake: from the beginning of the third month of life to the end of the tenth month; anthropometric measures: at the end of the fourth, seventh, tenth month||||||
752780|NCT00571948|Primary|Sum of Omega-3 Fatty Acid Pattern in Plasma|"fatty acids were measured in the whole plasma (in mg). They were transformed into percent (%) per total fatty acids.
Results are shown as percent (%) per total fatty acids before and after the intervention as median (percentile 25th;75th)."|at the end of the tenth month of life|||percent of total fatty acids||Inter-Quartile Range|Median
752781|NCT00571961|Primary|Buprenorphine Area Under the Curve With LPV/r (ng/mL*hr)|Pharmacokinetic parameters were determined by use of non compartmental methods. The area under the plasma concentration versus time curve was determined by use of the trapezoidal rule and measured over a 24-hr time period.|15 days|||(ng/mL)*hr||Standard Deviation|Mean
752782|NCT00571974|Primary|The Objective Response Rate is the Number of Participants With Significant Response (SR), Partial Response (PR) or No Response (NR).|The response rate was quantified by examination by an experienced head and neck surgeon and classified as follows: significant response (SR) was one where the lesion had greater than 75% resolution, partial response (PR) was one in which the lesion was reduced in size by at least 25%, and no response (NR) was one where the lesion was reduced by less than 25% in size.|Day 90|The Simon two-stage minimax design with 9 subjects in the first stage and 8 subjects in the second stage, yielding 17 subjects overall.||participants|||Number
752783|NCT00571974|Primary|Maximum Tolerated Dose|The traditional 3+3 dose escalation design was employed. Three cohorts were enrolled at 3 subjects per cohort, and treated with escalating radiant exposures of 6, 7, or 8 J/cm2. In each cohort, the number of dose-limiting toxicities (DLTs) were observed. Dose escalation rules were the same as those provided by Storer 1989.|Day 2|Three cohorts were enrolled at 3 subjects per cohort, and treated with escalating radiant exposures (laser doses) of 6, 7, or 8 J/cm2. In each cohort, the number of dose-limiting toxicities (DLTs) were observed. The highest radiant light dose attained that did not produce more than 2 DLTs was declared to be the maximum tolerated dose (MTD).||J/cm2|||Number
752784|NCT00571987|Secondary|Recurrence of Breast Cancer at Prior Site of Disease||Until study end (2 years)|During the 68-month median follow-up in patients not treated with XRT, there were 2 in-site tumor recurrences treated with AI, 3 biopsy entrance site recurrences treated with excision and XRT to conserve the breast, and 2 recurrences elsewhere and 1 contralateral recurrence; all 3 treated with mastectomy.||participants|||Number
752785|NCT00571987|Primary|Number of Patients Requiring 2nd Surgery for Close or Positive Margins|"A close surgical margin implies that cancer cells are found on pathology to be very close to the surgical margin, and a wide surgical margin implies the tumor exists far from the cut edge or the surgical margin. For this study, we defined close as less than 3 mm."|Margins assessed at Final Pathology, approximately 1 week post-RF surgery|||participants|||Number
752786|NCT00572039|Secondary|Vision-related Quality of Life|We administered the 25-item National Eye Institute Vision Function Questionaire plus Supplement (NEI-VFQ).19 This version of the NEI VFQ consists of 39 items that assess self-reported vision function and vision-related QoL. The latter yields a multidimensional index of vision-related health composed of social functioning (social interactions), mental health (worry, frustration), role difficulties (accomplishing less), and dependency (relying more on others) due to vision loss. Scores range from 0 to 100, with higher scores indicating better function.|6 months|105 PST and 110 ST participants provided data at 6 months.||units on a scale||Standard Deviation|Mean
752787|NCT00572039|Primary|Targeted Vision Function|We identified and quantified the TVF goals that subjects valued but found difficult to achieve. To derive the TVF measure, at baseline subjects completed the Activities Inventory, a structured vision function questionnaire that asks patients to rate the value and difficulty of 48 vision function goals (e.g., daily meal preparation) and the tasks (e.g., seeing stove settings) that are required to achieve them. If a goal is important (range of 0 [not important]to 4 [very important]), the subject rates its “difficulty” (on a scale of 0 [not difficult] to 4 [impossible]). The average TVF score is the sum of the difficulty ratings of the (up to) 4 self-selected goals divided by the number of goals (from 1 to 4). Higher average scores indicate greater disability. At each outcome assessment subjects again rated the difficulty of the same targeted goals and the average TVF score was calculated.|6 months|105 PST and 110 ST participants provided data at 6 months.||units on a scale||Standard Deviation|Mean
752788|NCT00572039|Secondary|Vision-related Quality of Life|We administered the 25-item National Eye Institute Vision Function Questionaire plus Supplement (NEI-VFQ).19 This version of the NEI VFQ consists of 39 items that assess self-reported vision function and vision-related QoL. The latter yields a multidimensional index of vision-related health composed of social functioning (social interactions), mental health (worry, frustration), role difficulties (accomplishing less), and dependency (relying more on others) due to vision loss. Scores range from 0 to 100, with higher scores indicating better function.|3-Months|106 PST and 112 ST participants provided data at 3 months.||units on a scale||Standard Deviation|Mean
752789|NCT00572039|Primary|Targeted Vision Function (TVF)|We identified and quantified the TVF goals that subjects valued but found difficult to achieve. To derive the TVF measure, at baseline subjects completed the Activities Inventory, a structured vision function questionnaire that asks patients to rate the value and difficulty of 48 vision function goals (e.g., daily meal preparation) and the tasks (e.g., seeing stove settings) that are required to achieve them. If a goal is important (range of 0 [not important]to 4 [very important]), the subject rates its “difficulty” (on a scale of 0 [not difficult] to 4 [impossible]). The average TVF score is the sum of the difficulty ratings of the (up to) 4 self-selected goals divided by the number of goals (from 1 to 4). Higher average scores indicate greater disability. At each outcome assessment subjects again rated the difficulty of the same targeted goals and the average TVF score was calculated.|3-Months|106 PST and 112 ST participants provided data at 3 months.||units on a scale||Standard Error|Mean
752790|NCT00572117|Secondary|Effect of Treatment on Mood Symptoms|The 17-item Hamilton Depression Rating Scale (HAM-D) is a standard measure of symptoms of depression with a scoring range of 0-53 points. Higher HAM-D scores represent more depression, so a lowering of HAM-D scores is considered a good outcome, an increase in HAM-D scores considered a worsening of outcomes.|Baseline and 12 weeks|||units on a scale||95% Confidence Interval|Mean
752791|NCT00572117|Primary|Amount of Alcohol Consumed|Average number of drinks/heavy drinking days/week as measured using the Timeline Follow Back (TLFB) scale. A heavy drinking day is defined as a 5 or more standard drinks in a single day for males, 4 or more standard drinks in a single day for females. Drinks are standardized across types of alcohol to estimate the amount of alcohol consumes. For example, a 12 oz. beer of 4-5% alcohol by volume is considered one drink.|Baseline and 12 weeks|||number of drinks per heavy drinking day||95% Confidence Interval|Mean
752792|NCT00572156|Secondary|Summary of Adverse Events With Number of Occurrences|A Data Monitoring Committee (DMC) was established to monitor subject safety|Approximately up to 4 years.|Safety population: Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.||Number of events|||Number
752793|NCT00572156|Secondary|Changes From Baseline (Day 1) in Serum Concentrations of Growth Hormone Binding Protein (GHBP)||At Baseline (Day 1), Year 1,2,3 and 4|Modified Intent-to-Treat (MITT) Population comprised all subjects who were randomized and had at least one post-baseline height measurement.||pmol/L||Standard Deviation|Mean
752794|NCT00572156|Secondary|Changes From Baseline (Day 1) in Serum Concentrations of Acid-Labile Subunit (ALS)||At Baseline (Day 1), Year 1,2,3 and 4|Modified Intent-to-Treat (MITT) Population comprised all subjects who were randomized and had at least one post-baseline height measurement.||mg/L||Standard Deviation|Mean
752795|NCT00572156|Secondary|Changes From Baseline (Day 1) in Serum Concentrations of Insulin-Like Growth Factor Binding Protein-3 (IGFPB-3)||At Baseline (Day 1), Year 1,2,3 and 4|Modified Intent-to-Treat (MITT) Population comprised all subjects who were randomized and had at least one post-baseline height measurement.||ng/mL||Standard Deviation|Mean
752799|NCT00572156|Secondary|Skeletal Maturation|"Assessed by bone age. Bone age was determined by the radiograph.
The SDS was calculated as: SDS=[(value /M)^L – 1] / LS; using power (L), Mean (M) and coefficient of variation (S). The reference values were dependent on gender in addition to age and were selected at the age the closest below subject’s age. SDS scores were calculated using L, M and S as defined in the National Center for Health Statistics 2000 data as provided by the Center for Disease Control (Kuczmarski, Ogden et al. 2002)"|At baseline(day 1), year 1,2,3 and 4|Completers, the completer population consists of all subjects that remained in the study until a specific time point (ie; Year 1, Year 2, Year 3 and Year 4).||SDS||Standard Deviation|Mean
752800|NCT00572156|Secondary|Total Change From Baseline (Day 1) in BMI SDS|"BMI was calculated by weight divided by height squared and measured as kilogram per square meter (kg/m^2).
The SDS was calculated as: SDS=[(value /M)^L – 1] / LS; using power (L), Mean (M) and coefficient of variation (S). The reference values were dependent on gender in addition to age and were selected at the age the closest below subject’s age. SDS scores were calculated using L, M and S as defined in the National Center for Health Statistics 2000 data as provided by the Center for Disease Control (Kuczmarski, Ogden et al. 2002)"|At year 1,2,3,4 and end of study (visit 23) versus baseline (day 1)|Completers, the completer population consists of all subjects that remained in the study until a specific time point (ie; Year 1, Year 2, Year 3 and Year 4).||SDS||Standard Deviation|Mean
752801|NCT00572156|Secondary|Predicted Adult Height (PAH)|"Predicted Adult Height calculated by method, Roche-Wainer-Thissen (RWT) and mid-parental target height SDS.
The SDS was calculated as: SDS=[(value /M)^L – 1] / LS; using power (L), Mean (M) and coefficient of variation (S). The reference values were dependent on gender in addition to age and were selected at the age the closest below subject’s age. SDS scores were calculated using L, M and S as defined in the National Center for Health Statistics 2000 data as provided by the Center for Disease Control (Kuczmarski, Ogden et al. 2002)"|At baseline (Day 1), year 1,2,3 and 4|Completers, the completer population consists of all subjects that remained in the study until a specific time point (ie; Year 1, Year 2, Year 3 and Year 4).||SDS||Standard Deviation|Mean
752802|NCT00572156|Secondary|Cumulative Change in Height Standard Deviation Score (SDS)|"Height was measured standing and without shoes, and recorded as the mean of three measurements (the subject being repositioned each time) by the same observer using a Harpenden or other wall-mounted stadiometer which was to be calibrated prior to measurement of each subject and a calibration log kept.
The SDS was calculated as: SDS=[(value /M)^L – 1] / LS; using power (L), Mean (M) and coefficient of variation (S). The reference values were dependent on gender in addition to age and were selected at the age the closest below subject’s age. SDS scores were calculated using L, M and S as defined in the National Center for Health Statistics 2000 data as provided by the Center for Disease Control (Kuczmarski, Ogden et al. 2002)"|First, second, third and fourth year|Modified Intent-To-Treat (MITT): MITT population comprised all subjects who were randomized and had at least one post-baseline height measurement.||SDS||Standard Deviation|Mean
752803|NCT00572156|Secondary|Height Velocity||Second, third and fourth year|Modified Intent-To-Treat (MITT): MITT population comprised all subjects who were randomized and had at least one post-baseline height measurement.||cm/y||Standard Deviation|Mean
752804|NCT00572156|Primary|Height Velocity||First year of treatment|"Modified Intent-To-Treat (MITT): MITT population comprised all subjects who were randomized and had at least one post-baseline height measurement.
[n= 25,27,27,26]"||cm/y||Standard Deviation|Mean
752805|NCT00572260|Primary|Rate of Patients Receiving Antimicrobial Prophylaxis Within the Appropriate Timeframe Before Incision||30 days after surgery|The study closed due to the departure of the principal investigator and the data analysis was not performed.|||||
752806|NCT00572468|Secondary|Compare the Effect of Pre-operative Simvastatin Versus Placebo on Prostate Cancer Cell Apoptosis and Its Mediators in Men Undergoing Planned Prostatectomy.|Compare the effect of pre-operative simvastatin versus placebo on prostate cancer cell apoptosis and its mediators in men undergoing planned prostatectomy. Apoptosis was measured by calculating the percent of Ki67 cellular staining.|2 years|We enrolled a total of 42 subjects, 36 completed this study. Of the 36 subjects who completed this study, only 26 subjects had tissue available for this analysis.||Percentage of cells||95% Confidence Interval|Mean
752807|NCT00572468|Primary|Measure the Effect of Pre-operative Simvastatin Versus Placebo on the Mevalonate Pathway Synthesis and Target Activation in Benign and Malignant Prostate Tissue.|Measure the effect of pre-operative simvastatin versus placebo on the mevalonate pathway synthesis and target activation in benign and malignant prostate tissue using Androgen Receptor (AR) antibody. AR was measured in tissue obtained at the time of prostatectomy in both benign and malignant tissues.|5 years|We enrolled a total of 42 subjects, 36 completed this study. Of the 36 subjects who completed this study, only 26 subjects had tissue available for this analysis.||Percentage of cells||95% Confidence Interval|Mean
752808|NCT00572533|Post-Hoc|RBC Units Transfused|Total number of RBC units transfused|12 months|Intent-To-Treat, Missing Data Excluded||RBC Units|||Number
752809|NCT00572533|Post-Hoc|Subjects Receiving Transfusion|Number of Subjects receiving Transfusion|12 months|Intent-To-Treat, Missing Data Excluded||Participants|||Number
752810|NCT00572533|Secondary|ESA Dose|Mean ESA dose per patient-week. ESA used: Epoetin Alfa (IV)|12 months|Intent-to-Treat Analysis, Missing Data Excluded||IU||Standard Deviation|Mean
752811|NCT00572533|Secondary|Mean Hb|Mean Hemoglobin concentration over follow-up period|12 months|Intent-To-Treat Analysis, Missing Data Excluded||g/dL||Standard Deviation|Mean
752812|NCT00572533|Secondary|Percent Hb > 12 g/dL|Percentage of Hemoglobin concentrations measured (once per month) greater than 12 g/dL.|12 months|Intent-To-Treat, Missed Data Excluded||Percent|||Number
752813|NCT00572533|Post-Hoc|Transfusion Events|Number of Transfusion Events|12 months|Intent-To-Treat, Missing Data Excluded||Events|||Number
752814|NCT00572533|Secondary|Percent Hb < 10 g/dL|Percentage of Hemoglobin concentrations measured (once per month) less than 10 g/dL.|12 months|Intent-To-Treat Analysis, Missing Data Excluded||Percent|||Number
752815|NCT00572533|Primary|Percent Hb 10-12 g/dL|Percentage of Hemoglobin concentrations measured (once per month) between 10 and 12 g/dL.|12 months|Intent-To-Treat Analysis, Missing Data Excluded||Percent|||Number
752816|NCT00572572|Secondary|Preferred Treatment Cycle|Participants were asked which treatment cycles was preferable - aprepitant or placebo cycle.|2 months|There were 49 subjects during the Aprepitant treatment and the Placebo treatment for each cycle that had complete data for the analysis of the preferred treatment cycle.||percentage of subjects with a preference|||Number
752817|NCT00572572|Secondary|MD Anderson Symptom Inventory Score|The MD Anderson Symptom Inventory (MDASI) is a brief measure of the severity and impact of cancer-related symptoms. Thirteen core items measure the severity of symptoms and six additional items measure the impact of symptoms. All items are rated on a scale from 0 (not present or did not interfere) to 10 (maximal severity or interference). The mean value of the total nineteen items ranges from 0 to 10.|Days 1-8|There were 64 subjects during the Aprepitant treatment and 62 subjects during the Placebo treatment for days 1-8 that had complete data for the analysis of the M.D. Anderson Symptom Inventory. The mean MDASI scores for days 1-8 combined, by treatment (Aprepitant vs. Placebo) were reported.||units on a scale||Standard Deviation|Mean
752818|NCT00572572|Secondary|Visual Analouge (VAS) 100mm Scale Score|The Visual Analouge (VAS) 100mm Scale Score for Chemotherapy Induced Nausea and Vomiting (CINV). Participants were asked to mark a linear scale 100mm in length representing their level of nausea with 0mm indicating no nausea and 100mm indicating severe nausea. The mean VAS scores for days 1-8 combined, by treatment (Aprepitant vs. Placebo) were reported.|Days 1-8|There were 54 subjects during the Aprepitant treatment and 61 subjects during the Placebo treatment for days 1-8 that had complete data for the analysis of the visual analouge scale for nausea and vomiting.||mm||Standard Deviation|Mean
752819|NCT00572572|Secondary|Proportion of Patients With no Emesis During the Delayed CINV Time Period (Cycle Days 6-8)|Proportion of patients with no emesis regardless of use of rescue medication during cycle days 6-8.|Participants were evaluated from cycle days 6-8.|||percentage of evaluable subjects|||Number
752820|NCT00572572|Secondary|Proportion of Patients With no Emesis During the Acute CINV Time Period (Cycle Days 1-5)|Proportion of patients with no emesis regardless of use of rescue medication during cycle days 1-5.|Participants were evaluated from cycle days 1-5.|||percentage of evaluable subjects|||Number
752821|NCT00572572|Primary|Complete Response.|Participants were followed for chemotherapy induced nausea and vomiting (CINV) through day 8 of cycle 2. Complete response is defined as no emetic episodes and no use of rescue medication.|Participants were evaluated from start of treatment through day 8 of cycle 2.|||percentage of evaluable subjects|||Number
752822|NCT00572624|Secondary|Mean Homeostasis Model Assessment of Insulin Resistance|The homeostasis model assessment of insulin resistance (HOMA) was used to calculate insulin resistance using the first AM, fasting glucose and insulin levels. Plasma insulin levels were measured by radioimmunoassay, and glucose levels were measured by automated hexokinase assay. A HOMA score of <3 represents normal insulin resistance, a score between 3 and 5 moderate insulin resistance, and a score of 5 or higher represents severe insulin resistance.|Measured at baseline, 16 months after gastric bypass surgery-induced weight loss, and 8 months after diet-induced weight loss|Participants who lost 5% of their body weight during the study||units on a scale||Standard Deviation|Mean
752823|NCT00572624|Secondary|Mean Total Serum Cholesterol and Triglycerides|Blood testing was conducted at scheduled times during the study. Serum cholesterol and triglycerides were measured by the enzymatic method (Roche Diagnostics).|Measured at baseline, 16 months after gastric bypass surgery-induced weight loss, and 8 months after diet-induced weight loss|Participants who lost 5% of their body weight during the study||mg/dl||Standard Deviation|Mean
752824|NCT00572624|Secondary|Mean Body Mass Index|Participant weight and height was measured at scheduled physical examinations. Body mass index was calculated as participant body weight in kilograms divided by their height in meters squared.|Measured at baseline, 16 months after gastric bypass surgery-induced weight loss, and 8 months after diet-induced weight loss|Participants who lost 5% of their body weight during the study||kg/m^2||Standard Deviation|Mean
752825|NCT00572624|Secondary|Mean Arterial Pressure|Mean arterial pressure was measured at scheduled physical examinations.|Measured at baseline, 16 months after gastric bypass surgery-induced weight loss, and 8 months after diet-induced weight loss|Participants who lost 5% of their body weight during the study||mm Hg||Standard Deviation|Mean
752826|NCT00572624|Secondary|Mean Heart Rate|Heart rate was measured at scheduled physical examinations.|Measured at baseline, 16 months after gastric bypass surgery-induced weight loss, and 8 months after diet-induced weight loss|Participants who lost 5% of their body weight during the study||beats per minute||Standard Deviation|Mean
752827|NCT00572624|Secondary|Left Ventricular (LV) Mass|Immediately following MVO2 measurement, complete two-dimensional, M-mode, and Doppler echocardiographic study were performed using second harmonic imaging. Left ventricular (LV) mass was measured using the area-length method. All reported measurements represent the average of three consecutive cardiac cycles. A single investigator blinded to all clinical parameters evaluated all echocardiograms.|Measured at baseline, 16 months after gastric bypass surgery-induced weight loss, and 8 months after diet-induced weight loss|Participants who lost 5% of their body weight during the study and for whom data are available||grams||Standard Deviation|Mean
752828|NCT00572624|Secondary|Septal Ratio (E/E’)|Immediately following MVO2 measurement, complete two-dimensional, M-mode, and Doppler echocardiographic studies were performed using second harmonic imaging. The early diastolic (E) velocity was measured, left ventricular relaxation (E’) was measured at the lateral mitral annulus, and the E/E’(septal) ratio was calculated. All reported measurements represent the average of three consecutive cardiac cycles. A single investigator blinded to all clinical parameters evaluated all echocardiograms. The normal septal ratio from the lateral mitral annulus is <5, a ratio from 5 to 10 is indeterminate, and a ratio of >10 indicates elevated left atrial pressure.|Measured at baseline, 16 months after gastric bypass surgery-induced weight loss, and 8 months after diet-induced weight loss|Participants who lost 5% of their body weight during the study and for whom data are available||ratio||Standard Deviation|Mean
752829|NCT00572624|Secondary|Left Ventricular (LV) Relaxation (E’)|Immediately following MVO2 measurement, complete two-dimensional, M-mode, and Doppler echocardiographic studies were performed using second harmonic imaging. Left ventricular relaxation (E’) was measured at the lateral annulus. All reported measurements represent the average of three consecutive cardiac cycles. A single investigator blinded to all clinical parameters evaluated all echocardiograms.|Measured at baseline, 16 months after gastric bypass surgery-induced weight loss, and 8 months after diet-induced weight loss|Participants who lost 5% of their body weight during the study and for whom data are available||cm/second||Standard Deviation|Mean
753261|NCT00567255|Secondary|Change in Waist Circumference||Baseline, 28 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||cm||Standard Error|Least Squares Mean
752830|NCT00572624|Primary|Total Myocardial Fatty Acid (FA) Oxidation|The evening before an imaging study, all participants were given a meal containing 12 kcal/kg adjusted body weight (=ideal body weight + ((actual body weight-ideal body weight) x 0.25)). Participants fasted until their imaging studies were completed. Myocardial fatty acid utilization was measured using positron emission tomography (PET) after injecting 1-^11C-palmitate. Total fatty acid oxidation was calculated by multiplying the fatty acid oxidation rate by left ventricular weight.|Measured at baseline, 16 months after gastric bypass surgery-induced weight loss, and 8 months after diet-induced weight loss|Participants who lost 5% of their body weight during the study and for whom data are available||nmol/g/min||Standard Deviation|Mean
752831|NCT00572624|Primary|Total Myocardial Fatty Acid (FA) Utilization|The evening before an imaging study, all participants were given a meal containing 12 kcal/kg adjusted body weight (=ideal body weight + ((actual body weight-ideal body weight) x 0.25)). Participants fasted until their imaging studies were completed. Myocardial blood flow was measured using positron emission tomography (PET) following injection of ^30O-water. Myocardial fatty acid (FA) utilization was measured using PET after injection of 1-^11C-palmitate. The calculations that describe the relationship between the different measures of myocardial FA metabolism are: FA utilization/gram = blood flow/gram × FA uptake/gram × [average plasma free FA at the time of the 1-11C-palmitate injection]; FA utilization/gram = FA oxidation/gram + esterification/gram. Total fatty acid utilization was calculated by multiplying the fatty acid utilization rate by left ventricular weight.|Measured at baseline, 16 months after gastric bypass surgery-induced weight loss, and 8 months after diet-induced weight loss|Participants who lost 5% of their body weight during the study and for whom data are available||nmol/g/min||Standard Deviation|Mean
752832|NCT00572624|Primary|Total Myocardial Oxygen Consumption (MVO2)|The evening before an imaging study, all participants were given a meal containing 12 kcal/kg adjusted body weight (=ideal body weight + ((actual body weight-ideal body weight) x 0.25)). Participants fasted until their imaging studies were completed. Myocardial oxygen consumption (MVO2) was measured using positron emission tomography (PET) following injection of 1-^11C-acetate. Total MVO2 was calculated by multiplying the MVO2 measure by left ventricular weight.|Measured at baseline, 16 months after gastric bypass surgery-induced weight loss, and 8 months after diet-induced weight loss|Participants who lost 5% of their body weight during the study||µmol/min||Standard Deviation|Mean
752833|NCT00572728|Secondary|%Change SUVmax From FLT1‐FLT3 to Predict Lymph Node Status at Surgery|%change in SUVmax from FLT1‐FLT3 will be compared by lymph node status at surgery For the purposes of reporting, %change in SUVmax from FLT1‐FLT3 will be consider the outcome.|Baseline (FLT-1) and post-NAC (FLT-3)|Data on 30 patients with FLT3 were available for histopathological LN evaluation after NAC: 11 with negative nodes, 13 with 1‐3 LN metastases and 6 with >3 LN metastases||percent change in SUVmax from FLT1‐FLT3||Standard Deviation|Mean
752834|NCT00572728|Secondary|%Change SUVmax From FLT1‐FLT2 to Predict Lymph Node Status at Surgery|Reported values in the Outcome Measure table represent %Change in uptake between FLT1 and FLT2, i.e., percentage change of SUVmax. The relationship between the change in uptake between FLT1 and FLT2 and lymph node (LN) status. For the purposes of reporting, the % Change in SUV will be considered the outcome.|Baseline (FLT-1) and Early Therapy (FLT-2)|Data on 38 patients having FLT1 and FLT2 were available for histopathological LN evaluation after NAC: 14 with negative nodes, 15 with 1‐3 LN metastases and 9 with >3 LN metastases||percent change in SUVmax from FLT1‐FLT2||Standard Deviation|Mean
752835|NCT00572728|Secondary|Change in Uptake Between FLT1 and FLT3 to Predict Pathologic Complete Response (pCR) of the Primary Tumor|"To evaluate the relationship between the change in uptake between FLT1 and FLT3 and pathologic complete response, an ROC curve will be estimated and the area under the curve (AUC), along with its 90% confidence interval, will be determined. For the purposes of reporting, we will consider the percent change in uptake between FLT1 and FLT3 to be the outcome.
Reported values in the Outcome Measure table represent Change in uptake between FLT1 and FLT3, i.e., percentage change of SUVmax. The relationship between the change in uptake between FLT1 and FLT3 and pathological complete response was assessed by using ROC analysis. The Area Under the ROC Curve is reported in the Statistical Analysis section"|Baseline (FLT-1) and post-NAC (FLT-3)|43 patients who had both FLT1 and FLT3 scans||percentage change in SUVmax||Standard Deviation|Mean
752836|NCT00572728|Secondary|SUVmax at FLT-3 Comparison Between Residual Cancer Burden (RCB) 0/I and RCB II/III|The Standard Uptake Values (max) after completion of NAC (FLT-3) were compared for Participants with Residual Cancer Burden 0/I vs Residual Cancer Burden of II/III While normally RCB (or other final determination) would be considered the outcome, since this is a predictive question, we will consider the mean of the uptake values the measurement of interest and report those values herein.|post-NAC (FLT-3)|After completion of NAC (FLT-3): only 31 patients had both FLT3 and RCB evaluation: 11 patients with RCB 0/I and 20 patients with RCB II/III||Standard Uptake Values (SUVmax)||Standard Deviation|Mean
752837|NCT00572728|Secondary|SUVmax at FLT-2 Comparison Between Residual Cancer Burden (RCB) 0/I and RCB II/III|"While normally RCB (or other final determination) would be considered the outcome, since this is a predictive question, we will consider the uptake values the measurement of interest and report those values herein.
Mean Standard Uptake Values (max) after one cycle of NAC (FLT2) were compared for Participants with Residual Cancer Burden (RCB) 0/I vs RCB II/III"|early treatment (FLT2)|after one cycle of NAC (FLT2): 35 patients had FLT-2 and RCB evaluation: 14 patients with RCB 0/I and 21 patients with RCB II/III||Standard Uptake Values (SUVmax)||Standard Deviation|Mean
752838|NCT00572728|Secondary|SUVmax at FLT-1 Comparison Between Residual Cancer Burden (RCB) 0/I and RCB II/III|"While normally RCB (or other final determination) would be considered the outcome, since this is a predictive question, we will consider the Standardized Uptake Values the measurement of interest and report those values herein.
Mean Standard Uptake Values (max) at Baseline (FLT-1) were compared for Participants with Residual Cancer Burden 0/I vs Residual Cancer Burden of II/III"|Baseline (FLT-1)|@ Baseline: 35 patients with FLT-1 were evaluable for RCB: 14 patients with RCB 0/I and 21 patients with RCB II/III||Standard Uptake Values (SUVmax)||Standard Deviation|Mean
752839|NCT00572728|Secondary|Correlation Between SUVmax and Ki‐67 LI at FLT3 (Post-NAC)|For the purposes of reporting, SUVmax @ FLT-3 will be considered the outcome. correlation between the fraction of Ki-67-positive tumor cells (the Ki-67 labeling index) and SUVmax at FLT-3 Ki‐67 labeling index (LI) was calculated as the number of Ki‐67 positive tumor cells per one thousand tumor cells.|Post-NAC (FLT3)|43 patients who had suitable post‐NAC tissue samples for correlation between surgical specimens and FLT3 SUVs||Standard Uptake Values (SUVmax)||Standard Deviation|Mean
752840|NCT00572728|Secondary|Correlation Between SUVmax and Ki‐67 LI at FLT1(Baseline PET)|"For the purposes of reporting, SUVmax @ FLT1 will be considered the outcome. the correlation is measured between the fraction of Ki-67-positive tumor cells (the Ki-67 labeling index) and SUVmax at FLT1 .
Ki‐67 labeling index (LI) was calculated as the number of Ki‐67 positive tumor cells per one thousand tumor cells."|Baseline (FLT-1)|1 of the 73 participants did not have both FLT-1 and Ki-67 LI available data||Standard Uptake Values (SUVmax)||Standard Deviation|Mean
752841|NCT00572728|Primary|%Change in FLT Uptake Between the Baseline (Pre-therapy) and the Early-therapy Imaging Studies to Predict Pathological Complete Response|The primary statistical evaluation will be based on the percent change in FLT SUV60 between baseline (pre-therapy, FLT-1) and the early-therapy imaging (5-10 days after chemotherapy, FLT-2) studies|Baseline (FLT-1) to early therapy (5-10 days after chemotherapy, FLT-2)|Percent Change in Maximum Standardized FLT uptake between the baseline (pre-therapy, FTL-1) and the early-therapy imaging (5-10 days after chemotherapy, FLT-2)||percentage change of SUVmax||Standard Deviation|Mean
752842|NCT00572832|Primary|Geometric Mean Antibody Titers Following the Third Dose of Human Papilloma Virus (HPV) Vaccine by Virus Type and by Administration Schedule|Geomtric mean antibody titers were assessed 1 month following the third dose of human papilloma virus vaccine. Persons with baseline antibody titers that were positive to a particular type were deleted from the analysis for that particular type so that the outcome is excludes those with baseline positives (thus, sample size varies by type). Responses were compared between the two groups after dose 3 by type.|1 month post-dose 3 (i.e., 7 months for standard schedule and 13 months for alternative schedule)|The analysis was by intention to treat. Participants who had positive baseline antibody titers were excluded from further analyses only for the type(s) for which they were seropositive.||milliMerck units per mL||95% Confidence Interval|Geometric Mean
752843|NCT00572897|Secondary|Transplant-related Mortality|Transplant-related Mortality including Graft-versus-host disease (GVHD)|2 years|||participants|||Number
752844|NCT00572897|Secondary|PLT|Patients with PLT ≥20 × 109/L|2 years|||participants|||Number
752845|NCT00572897|Secondary|Absolute Neutrophil Count (ANC)|Patients with ANC ≥0.5 × 10^9/L|2 years|||participants|||Number
752846|NCT00572897|Secondary|Overall Survival|The number of patients alive at last follow-up.|73 months|||participants|||Number
752847|NCT00572897|Secondary|Response Outcomes|assessed according to the IWG Criteria|180 days|Clinical responses were assessed according to the IWG-MRT 2006 criteria in 46 patients (29 sibling and 17 unrelated transplants) who survived at least 180 days.||participants|||Number
752848|NCT00572897|Primary|The Primary Endpoint is Progression-free Survival.|Number of participants alive at 2 years who are progression-free|2 years|||participants|||Number
752849|NCT00572910|Primary|Number of Participants With Adverse Experiences (AE)/Serious Adverse Experiences (SAE)|"Participants with Adverse Experiences (AE) / Serious Adverse Experiences (SAE) occurring Day 1 through Day 14 following vaccinations 1, 2, and 3.
Participants with specific SAEs including any vaccine-related SAEs, any SAEs involving a Staphylococcus aureus (S. aureus) infection, or any AEs leading to death occurring Day 1 through Day 360 following vaccination."|Days 1-14 following each vaccination for any AE/SAE and Days 1-360 for any vaccine-related SAEs, S. aureus SAEs, or deaths.|||Participants|||Number
752850|NCT00572910|Secondary|GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints|Participants whose GMFR in 0657n-specific IgG antibody concentration from baseline through Day 360 for all groups (including Days 28, 56, 84,180, 210, 270, and 360) to assess the durability and kinetics of the immune response.|Prevaccination to 360 days post vaccination|||Ratio||95% Confidence Interval|Geometric Mean
752851|NCT00572910|Secondary|GMFR in 0657n-specific IgG Antibody Concentration From Baseline to 56 Days After the Administration of a Single V710 Vaccination|Participants whose GMFR in 0657n-specific IgG antibody concentration from Baseline to Day 56 for the 2 Groups receiving a single dose of V710 (60 mcg without MAA followed by Placebo 28 Days later) Group 2, and (60 mcg with MAA followed by Placebo 28 days later) Group 4.|Prevaccination to 56 days postvaccination|||Ratio||95% Confidence Interval|Geometric Mean
752852|NCT00572910|Secondary|GMFR in 0657n-specific IgG Antibody Concentration From Baseline to Day 180 After the Administration of the First V710 Vaccination|Participants whose GMFR in anti-0657n IgG antibody concentration was measured from Baseline to Day 180 for the 3 Groups receiving 2 doses of V710 28 days apart (60 mcg without MAA) Group 1, (60 mcg with MAA) Group 3 and (90 mcg with MAA) Group 5.|Prevaccination to 180 days postvaccination|||Ratio||95% Confidence Interval|Geometric Mean
752853|NCT00572910|Secondary|GMFR in 0657n-specific IgG Antibody Concentration From Baseline to Day 28 After the Administration of the First V710 Vaccination|Participants whose GMFR in anti-0657n IgG antibody concentration was measured from Baseline to Day 28 for the 3 Groups receiving 1 dose of V710 (60 mcg without MAA) Group 1 and 2 combined, (60 mcg with MAA) Group 3 and 4 combined and (90 mcg with MAA) Group 5.|Prevaccination to 28 days postvaccination|||Ratio||95% Confidence Interval|Geometric Mean
752854|NCT00572910|Primary|Geometric Mean Fold-rise (GMFR) in 0657n-specific Immunoglobulin G (IgG) Antibody Concentration From Baseline to 28 Days After the Administration of the Second V710 Vaccination|Participants whose GMFR in anti-0657n IgG antibody concentration was measured by the LUMINEX™ assay from Baseline to 28 days after the administration of the second vaccination of V710 for the 3 groups receiving 2 doses of V710 (60 mcg without MAA) Group 1, (60 mcg with MAA) Group 3 and (90 mcg with MAA) Group 5.|Prevaccination to 56 days postvaccination|||Ratio||95% Confidence Interval|Geometric Mean
752855|NCT00573066|Primary|PK Profile of Dexmedetomidine|This study measured the concentration of dex in the body and used those concentrations to determine how quickly the body metabolizes and eliminates dex(concentration-time or pharmacokinetic profile).The concentration of dex in the body is determined through serial blood sampling while administering dex and following discontinuation.|after start of infusion (0.5, 1, 2, 4-6 hours), immediately prior to end of infusion and following end of infusion (0.25, 0.5, 1, 2, 4, 8, 12, 15-18 hours)|Based on an estimated inter-subject variability of 50% for steady state concentration, a sample size of 36 evaluable subjects will be sufficient to detect a difference (alpha 0.05, power 0.8) for the area under the concentration-time curve (AUC) and steady state concentration (Css) between the three dosing groups.||mL/min/(kg^0.75)||Standard Error|Least Squares Mean
753675|NCT00577824|Secondary|Change in Fasting Blood Glucose|Change in fasting blood glucose from baseline to endpoint (i.e., fasting blood glucose at week 24 minus fasting blood glucose at week 0)|baseline, week 24|Full analysis set; Last observation carried forward||mg/dL||Standard Error|Least Squares Mean
752857|NCT00573144|Secondary|Myocardial Infarct Size at 30 Days|Myocardial infarction or acute myocardial infarction (AMI) is the medical term for an event commonly known as a heart attack. Myocardial (heart muscle) infarction is tissue death (also known as necrosis) caused by a local lack of oxygen, due to an obstruction of the tissue's blood supply. The resulting heart tissue lesion is referred to as an infarct. A larger size or area of infarct indicates a greater amount of heart tissue death. Myocardial infarct size was measured using a cardiac Magnetic Resonance Imaging (MRI) scan at 30 days and is the mass of the infarcted tissue divided by the mass of the left ventricle times 100%.|30 days|||percentage of total cardiac tissue mass||Standard Deviation|Mean
752858|NCT00573144|Secondary|Change in Left Ventricular End-Systolic Diastolic Volume Index|Change in Left Ventricular end-systolic diastolic volume index determined by Multiple Gated Acquisition (MUGA) scan from baseline to 30 days. The MUGA scan is a noninvasive tool for assessing the function of the heart. The MUGA scan produces a moving image of the beating heart, and from this image several important features can be determined about the health of the cardiac ventricles (the heart’s major pumping chambers). End-systolic volume (ESV) is the volume of blood in a ventricle at the end of contraction, or systole, and the beginning of filling, or diastole. ESV is the lowest volume of blood in the ventricle at any point in the cardiac cycle and can be used clinically as a measurement of the adequacy of cardiac emptying, related to systolic function.|baseline, 30 days|||mL blood/meter^2 body surface area||Standard Deviation|Mean
752859|NCT00573144|Primary|Change in Left Ventricular End-Systolic Volume Index|Change in Left Ventricular end-systolic volume index as determined by Multiple Gated Acquisition (MUGA) scan from baseline to 30 days. The MUGA scan is a noninvasive tool for assessing the function of the heart. The MUGA scan produces a moving image of the beating heart, and from this image several important features can be determined about the health of the cardiac ventricles (the heart’s major pumping chambers). End-systolic volume (ESV) is the volume of blood in a ventricle at the end of contraction, or systole, and the beginning of filling, or diastole. ESV is the lowest volume of blood in the ventricle at any point in the cardiac cycle and can be used clinically as a measurement of the adequacy of cardiac emptying, related to systolic function.|baseline, 30 days|||mL of blood/meter^2 body surface area||Standard Deviation|Mean
752860|NCT00573157|Secondary|Number of Participants With New Lupus Flares||At Week 52|Due to early termination of the study caused by unanticipated safety issues, the outcome measure was not assessed.|||||
752861|NCT00573157|Secondary|Percentage of Participants With Normalization of Renal Function||At Week 52|Due to early termination of the study caused by unanticipated safety issues, the outcome measure was not assessed.|||||
752862|NCT00573157|Primary|Percentage of Participants With Confirmed Complete Renal Response (CRR), Partial Response, and Non-response|Complete renal response (CRR): from baseline, a return to within 10% of normal for renal function (assessed by calculated glomerular filtration rate [GFR]), improvement in proteinuria (urine protein/creatinine ratio <0.5) & resolution of hematuria. Partial response (PR): from baseline, a <= 10% worsening in renal function ( by calculated GFR); 50% improvement in proteinuria (assessed by urine protein/creatinine ratio) & resolution of hematuria, Non-response (NR): Neither criteria for CR or PR was met. Subjects were also deemed NR if they had treatment failure, regardless of CR or PR status. Subjects cannot be treatment failures. A response of CRR was confirmed if the Week 52 value is CRRand if the Week 48 value is CRR and at least 4 weeks apart from Week 52 /if the Week 48 value was missing/ less than 4 weeks from Week 52, then the Week 56 response must be CRR - if the Week 52 value was missing, then Week 48 and Week 56 must be CRR.|At Week 52|Due to early termination of the study caused by unanticipated safety issues, the outcome measure was not assessed.|||||
752863|NCT00573170|Secondary|"Numbers of Participants Able to Engage in Normal Activities Not Impaired at Time of Dosing and 2, 4, 6, and 8 Hours After Dosing as Assessed by the CDQ (Clinical Disability Questionnaire)"|"Clinical disability for each participant was assessed using the CDQ. This scale uses one question to assess ability to perform normal or usual activities. Responses are recorded on a 5-point scale, where 1 is normal/not impaired, 2 is mildly impaired, 3 is moderately impaired, 4 is severely impaired, and 5 is 'required bedrest."|At dosing and at 2, 4, 6 and 8 hours after dosing of each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population||participants|||Number
752864|NCT00573170|Secondary|Total PPMQ-R Score as Measured With the Revised Patient Perception of Migraine (PPMQ-R) Questionnaire 24 Hours After Taking Study Medication|The PPMQ-R questionnaire was used to assess participant satisfaction with migraine medication; the answers are used to generate a total score and 4 subscales scores for efficacy, functionality, ease-of-use and bothersomeness-of-side effects. The total score was calculated as the average of the efficacy, functionality and ease-of-use subscores. Subscores could range from 0 to 100; higher scores indicate greater satisfaction.|At 24 hours after dosing for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population: those participants who provided any information for the PPMQ-R.||scores on a scale||Standard Error|Mean
752865|NCT00573170|Secondary|Bothersomeness-of-side Effect Subscore as Measured by the Revised Patient Perception of Migraine (PPMQ-R) Questionnaire 24 Hours After Taking Study Medication|The PPMQ-R questionnaire was used to assess participant satisfaction with migraine medication; the answers are used to generate a total score and 4 subscales scores for efficacy, functionality, ease-of-use and bothersomeness-of-side effects. The total score was calculated as the average of the efficacy, functionality and ease-of-use subscores. Subscores could range from 0 to 100; higher scores indicate greater satisfaction.|At 24 hours after dosing for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population: those participants who provided any information for the PPMQ-R.||scores on a scale||Standard Error|Mean
752875|NCT00573170|Secondary|Number of Participants With Pain-freedom and Relief of Vomiting at 2, 4, 6, 8, 24 and 48 Hours Post-dose|The number of participants with no pain and relief of vomiting in those participants for whom vomiting was present at dose time. Participants using rescue medication were removed from the participants with relief group for all subsequent timed assessments, regardless of pain and associated symptom evaluations at the specified time point.|At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population - including only those participants who reported vomiting at dose time.||participants|||Number
752866|NCT00573170|Secondary|Ease-of-Use Subscore as Measured by the Revised Patient Perception of Migraine (PPMQ-R) Questionnaire 24 Hours After Taking Study Medication|The PPMQ-R questionnaire was used to assess participant satisfaction with migraine medication; the answers are used to generate a total score and 4 subscales scores for efficacy, functionality, ease-of-use and bothersomeness-of-side effects. The total score was calculated as the average of the efficacy, functionality and ease-of-use subscores. Subscores could range from 0 to 100; higher scores indicate greater satisfaction.|At 24 hours after dosing for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population: those participants who provided any information for the PPMQ-R.||scores on a scale||Standard Error|Mean
752867|NCT00573170|Secondary|Functionality Subscore as Measured by the Revised Patient Perception of Migraine (PPMQ-R) Questionnaire 24 Hours After Taking Study Medication|The PPMQ-R questionnaire was used to assess participant satisfaction with migraine medication; the answers are used to generate a total score and 4 subscales scores for efficacy, functionality, ease-of-use and bothersomeness-of-side effects. The total score was calculated as the average of the efficacy, functionality and ease-of-use subscores. Subscores could range from 0 to 100; higher scores indicate greater satisfaction.|At 24 hours after dosing for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population: those participants who provided any information for the PPMQ-R.||scores on a scale||Standard Error|Mean
752868|NCT00573170|Secondary|Efficacy Subscore as Measured by the Revised Patient Perception of Migraine (PPMQ-R) Questionnaire 24 Hours After Treating a Migraine|The PPMQ-R questionnaire was used to assess participant satisfaction with migraine medication; the answers are used to generate a total score and 4 subscales scores for efficacy, functionality, ease-of-use and bothersomeness-of-side effects. The total score was calculated as the average of the efficacy, functionality and ease-of-use subscores. Subscores could range from 0 to 100; higher scores indicate greater satisfaction.|At 24 hours after dosing for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population: those participants who provided any information for the PPMQ-R.||scores on a scale||Standard Error|Mean
752869|NCT00573170|Secondary|Mean Stanford Sleepiness (SS) Scale Scores at Time of Dosing and at 2, 4, 6, 8, 24 and 48 Hours After Dosing|"Participant alertness was evaluated with the 7-point modified SS scale, where 1 is feeling active, vital, alert, wide awake, 2 is still functioning at high levels, but not peak; able to concentrate, 3 is awake, but relaxed; responsive but not fully alert, 4 is somewhat foggy, let down, 5 is foggy, losing interest in remaining awake, 6 is sleepy, woozy, fighting sleep, prefer to lie down, and 7 is no longer fighting sleep, sleep onset soon, having dream like thoughts."|Dose time, 2, 4, 6, 8, 24 and 48 hours post-dose. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population. Only participants who responded to the SS scale at a particular time point were included in the analysis for that time point.||units on a scale||Standard Deviation|Mean
752870|NCT00573170|Secondary|Mean Performance Index (PI) Scores at Time of Dosing and at 2, 4, 6, 8, 24 and 48 Hours After Dosing|Overall cognition was assessed with a composite score (range 0-9) called the Performance Index, as derived from the number of correct responses per minute on subtests of the Mental Efficiency Workload Test (MEWT) cognitive battery. For a particular participant, lower scores indicate a negative impact, or worsened, general cognition; higher scores indicate improved cognition.|At time of dosing, and at 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population||scores on a scale||Standard Deviation|Mean
752871|NCT00573170|Secondary|Number of Participants Who Reported a Complete Symptom-Free Response at 2, 4, 6, 8, 24 and 48 Hours After Dosing|Complete symptom-free is defined as migraine-free, neck pain-free, and sinus pain-free without the use of any rescue medication prior to the defined time point.|At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population||participants|||Number
752872|NCT00573170|Secondary|Number of Participants With Pain Relief at 2, 4, 6, 8, 24 and 48 Hours After Dosing Moderate or Severe Baseline Pain|Pain relief is defined as having no or mild pain and no use of rescue medication after dosing in those participants who had moderate or severe pain at dosing.|At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population - only participants who reported moderate or severe baseline pain were included in this analysis.||participants|||Number
752873|NCT00573170|Secondary|Number of Participants With Relief From Neck Pain at 2, 4, 6, 8, 24 and 48 Hours After Dosing Who Also Had the Symptom at Baseline|The number of participants with no pain and relief of neck pain in those participants for whom neck pain was present at dose time. Participants using rescue medication were removed from the participants with relief group for all subsequent timed assessments, regardless of pain and associated symptom evaluations at the specified time point.|At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population - including only those participants who reported neck pain at dose time.||participants|||Number
752874|NCT00573170|Secondary|Number of Participants With Relief From Sinus/Facial Pain at 2, 4, 6, 8, 24 and 48 Hours After Dosing in Those Who Also Had the Symptom at Dosing|The number of participants with no pain and relief of sinus/facial pain in those participants for whom sinus/facial pain was present at dose time. Participants using rescue medication were removed from the participants with relief group for all subsequent timed assessments, regardless of pain and associated symptom evaluations at the specified time point.|At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population - including only those participants who reported sinus/facial pain at dose time.||participants|||Number
752911|NCT00573430|Secondary|Change of Systolic and Diastolic Blood Pressure From Baseline||baseline to 28 weeks|||mmHg||Standard Deviation|Mean
767782|NCT00691054|Secondary|Number of Participants Showing Stable Disease|Number of participants showing stable disease according to RECIST 1.0 criteria|12 months|||participants|||Number
752876|NCT00573170|Secondary|Number of Participants With Pain-freedom and Relief of Phonophobia at 2, 4, 6, 8, 24 and 48 Post-dose Time Points|The number of participants with no pain and relief of phonophobia in those participants for whom phonophobia was present at dose time. Participants using rescue medication were removed from the participants with relief group for all subsequent timed assessments, regardless of pain and associated symptom evaluations at the specified time point.|At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population - including only those participants who reported phonophobia at dose time.||participants|||Number
752877|NCT00573170|Secondary|Number of Participants With Pain-freedom and Relief of Photophobia at 2, 4, 6, 8, 24 and 48 Post-dose Time Points|The number of participants with no pain and relief of photophobia in those participants for whom photophobia was present at dose time. Participants using rescue medication were removed from the participants with relief group for all subsequent timed assessments, regardless of pain and associated symptom evaluations at the specified time point.|At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population - including only those participants who reported photophobia at dose time.||participants|||Number
752878|NCT00573170|Secondary|Number of Participants With Pain-freedom and Relief of Nausea at 2, 4, 6, 8, 24 and 48 Post-dose Time Points|The number of participants with no pain and relief of nausea in those participants for whom nausea was present at dose time. Participants using rescue medication were removed from the participants with relief group for all subsequent timed assessments, regardless of pain and associated symptom evaluations at the specified time point.|At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population - including only those participants who reported nausea at dose time.||participants|||Number
752879|NCT00573170|Secondary|Number of Participants With a Migraine-free Response 2-48 Hours After Dosing|Migraine-free is defined as pain-free with no migraine-associated symptoms (nausea, vomiting, photophobia [sensitivity to light], and phonophobia [sensitivity to sound]) with use of any rescue medication before the defined time point.|At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population||participants|||Number
752880|NCT00573170|Secondary|Mean Time to First Use of Rescue Medication for the Third Attack Treated With Study Medication (Attack 3)|Average time until participants took any medication to treat their migraine pain or symptoms within 48 hours after they took the first dose of study medication (placebo, Treximet, or butalbital-containing combination medication) for their third migraine attack treated in the study. Participants were asked not to take rescue for at least 2 hours after they took the study medication (placebo, Treximet, or butalbital-containing combination medication) for that attack. Participants took rescue medication if they felt they needed it.|From dose time through 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|Participants in the ITT population who treated migraine Attack 3 with study medication and then used migraine rescue medication after dosing.||hours||Standard Deviation|Mean
752881|NCT00573170|Secondary|Mean Time to First Use of Rescue Medication for the Second Attack Treated With Study Medication (Attack 2)|Average time until participants took any medication to treat their migraine pain or symptoms within 48 hours after they took the first dose of study medication (placebo, Treximet, or butalbital-containing combination medication) for their second migraine attack treated in the study. Participants were asked not to take rescue for at least 2 hours after they took the study medication (placebo, Treximet, or butalbital-containing combination medication) for that attack. Participants took rescue medication if they felt they needed it.|From dose time through 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|Participants in the ITT population who treated migraine Attack 2 with study medication and then used migraine rescue medication after dosing.||hours||Standard Deviation|Mean
752882|NCT00573170|Secondary|Mean Time to First Use of Rescue Medication for the First Attack Treated With Study Medication (Attack 1)|Average time until participants took any medication to treat their migraine pain or symptoms within 48 hours after they took the first dose of study medication (placebo, Treximet, or butalbital-containing combination medication) for the first migraine attack treated. Participants were asked not to take rescue for at least 2 hours after they took the study medication (placebo, Treximet, or butalbital-containing combination medication) for that attack. Participants took rescue medication if they felt they needed it.|From dose time through 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|Participants in the ITT population who treated migraine Attack 1 with study medication and then used migraine rescue medication after dosing.||hours||Standard Deviation|Mean
752883|NCT00573170|Secondary|Number of Participants Using Rescue Medication Within 48 Hours Post Dose|Number of participants who took any medication to treat their migraine pain or symptoms within 48 hours after they took the first dose of study medication (placebo, Treximet, or butalbital-containing combination medication) for that attack. Participants were asked not to take rescue for at least 2 hours after they took the study medication (placebo, Treximet, or butalbital-containing combination medication) for that attack. Participants took rescue medication if they felt they needed it.|From dose time through 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population||participants|||Number
752884|NCT00573170|Secondary|Number of Participants With a Pain-free Response From 2 to 48 Hours Post-dose|Pain-Free is defined as having no pain and without the use of any rescue medication from the time of the initial dose of study medication for a particular migraine attack until the defined time point at 2, 4, 6, 8, 24 or 48 hours post-dose.|At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population||participants|||Number
752885|NCT00573170|Primary|Number of Participants With a Sustained Pain-free (SPF) Response From 2 to 24 Hours Post-dose|SPF 2-24 hours is defined for all participants as having no pain at 2 hours post-dose and without the return of any pain or the use of any rescue medication (any medication taken after the first dose of study medication for any migraine pain or symptoms) from 2-24 hours.|From 2 to 24 hours post-dose. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|Intent-to-Treat (ITT) Population: all participants who were treated with investigational product and provided at least one post-dose efficacy assessment . Participants may have been included in one, two, or all of the Placebo, Treximet and Butalbital-containing combination medication arms due to the cross-over nature of the study design.||participants|||Number
752886|NCT00573183|Secondary|Attendance at 12-step Meetings|Days of attendance at 12-step meetings within 30-day blocks across a 6-month post-baseline period|6 months|The sample size was originally powered based on the primary outcome measure, not on the secondary 12-step measures.The analysis sample size was reduced due to missing values||days of attending 12-step meetings||Standard Deviation|Mean
752887|NCT00573183|Primary|Days of Stimulant Use|Number of days of use of stimulant drugs within 30-day blocks across a 6-month post-baseline period|6 months|The original sample size was based on power analysis and took attrition into account. Of the 471 individuals randomized to treatment, 50 subjects (TAU, n=20, STAGE-12, n=30) did not have any post-baseline measures and were therefore eliminated from the statistical analysis of the primary outcome and some of the secondary outcomes.||days of stimulant use||Standard Deviation|Mean
752888|NCT00573248|Primary|Side Effects|Mean percentage of endorsement for each electronic diary item (percent of 'yes' on an item) during 2 days on nicotine patches versus 2 days placebo patches|4 days|||Percent of item endorsement||Standard Error|Mean
752889|NCT00573248|Primary|Negative Moods|Mean percentage of endorsement for each electronic diary item (percent of 'yes' on an item) during 2 days on nicotine patches versus 2 days placebo patches|4 days|||Percent of item endorsement||Standard Error|Mean
752890|NCT00573248|Secondary|Blood Pressure|Average blood pressure during 2 days on nicotine patches versus 2 days on placebo patches|4 days|||mm HG||Standard Deviation|Mean
752891|NCT00573248|Primary|ADHD Symptoms|Mean percentage of endorsement for each electronic diary item (percent of 'yes' on an item) during 2 days on nicotine patches versus 2 days placebo patches|4 days|Per protocol, average ADHD symptoms, cardiovascular activity and moods during nicotine compared to placebo.||Percent of item endorsement||Standard Error|Mean
752892|NCT00573261|Secondary|To Assess the Change in Disability Scale Upon Treatment of Pregabalin in Comparison to Placebo.|The Sheehan Disability Scale was used to evaluate functional impairment in work/school, social and family life, score range, 0-10; the 3 items can be summed into a single dimensional measure of global functional impairment that ranges from 0(unimpaired) to 30 (highly impaired).|baseline and at end of a 4-week intervention|||units on a scale||Standard Deviation|Mean
752893|NCT00573261|Secondary|To Assess the Change of Depressive Symptoms Upon Treatment of Pregabalin in Comparison to Placebo.|The Beck Depression Inventory Scale measures symptoms of depression, score range, 0-63 (higher score=greater severity of depressive symptoms)|baseline and at end of a 4-week intervention|||units on a scale||Standard Deviation|Mean
752894|NCT00573261|Secondary|To Assess the Change of Anxiety Symptoms Upon Treatment of Pregabalin in Comparison to Placebo.|Anxiety symptoms were measured using the Spielberger State-Trait Anxiety Inventory Scale (STAI) for symptoms of anxiety. State anxiety: score range, 20-80 (higher score=greater levels of state anxiety). Trait anxiety: score range, 20-80 (higher score=greater levels of trait anxiety).|baseline and at end of a 4-week intervention|||units on a scale||Standard Deviation|Mean
752895|NCT00573261|Primary|Assessing the Change of Parameters of Autonomic Nerve Function Such as Heart Rate Variability by Means of the LifeShirt System Upon Treatment of Pregabalin vs. Placebo in Patients With Diabetes and Peripheral Neuropathy.|Heart rate variability parameters yielded by time domain analysis included the number of N-N intervals that differ by more than 50 milliseconds from adjacent intervals divided by the total number of all N-N intervals (pNN50).|baseline and at end of a 4-week intervention|||Ratio||Standard Deviation|Mean
752896|NCT00573261|Primary|Assessing the Change of Parameters of Autonomic Nerve Function Such as Heart Rate Variability by Means of the LifeShirt System Upon Treatment of Pregabalin vs. Placebo in Patients With Diabetes and Peripheral Neuropathy.|Heart rate variability parameters yielded by time domain analysis included the number of N-N intervals that differ by more than 50 milliseconds from adjacent intervals divided by the total number of all N-N intervals (pNN50).|baseline and at end of a 4-week intervention|||Intervals more than 50 ms||Standard Deviation|Mean
752897|NCT00573261|Primary|Assessing the Change of Parameters of Autonomic Nerve Function Such as Heart Rate Variability by Means of the LifeShirt System Upon Treatment of Pregabalin vs. Placebo in Patients With Diabetes and Peripheral Neuropathy.|Heart rate variability parameters yielded by time domain analysis included the mean of all R-R intervals (ANN), standard deviation of all R-R intervals (SDNN), root mean square of successive differences (RMSSD), and standard deviation of the averages of R-R intervals for all 5-minute segments within the block (SDANN).|baseline and at end of a 4-week intervention|A data card failure of the baseline heart rate record with the VivoMetrics system occurred for one subject who had completed baseline and 4-week assessments, leaving 28 subjects (n=13 in placebo, n=15 in pregabalin)having both completed baseline and end of 4-week R-R intervals for heart rate variability analysis.||milliseconds||Standard Deviation|Mean
752898|NCT00573261|Primary|Assessing the Change in Heart Rate Variability by Means of the LifeShirt System Upon Treatment of Pregabalin vs. Placebo in Patients With Diabetes and Peripheral Neuropathy.|Heart Rate Variability parameters generated by the frequency domain analysis included: Low Frequency / High Frequency (LF/HF), as well as normalized LF (normalized LF=LF/[total power-VLF]) and normalized HF (normalized HF=HF/[total power-VLF]).|baseline and at end of a 4-week intervention|||Ratio||Standard Deviation|Mean
752912|NCT00573430|Primary|The Change in Urinary Protein/Creatinine Ratio From Baseline to 28 Weeks|Decrease of urinary protein/creatinine ratio means improvement of renal disease.|baseline to 28 weeks|||mg/g||Standard Deviation|Mean
753130|NCT00566254|Secondary|Percent of Participants With =25% and =100% Increase From Baseline in 28-day Seizure Frequency During the Maintenance Period (LOCF)|Participants' parent or guardian maintained a seizure diary recording the date, number, and type of seizures the subject had. Seizure frequency of simple partial, complex partial, and partial seizures with secondary generalization were assessed.|Baseline (Week -8 to Week 0) and Week 8 to Week 20|ITT Population||Percentage of Participants|||Number
752899|NCT00573261|Primary|Assessing the Change in Heart Rate Variability by Means of the LifeShirt System Upon Treatment of Pregabalin vs. Placebo in Patients With Diabetes and Peripheral Neuropathy.|Heart rate variability parameters generated by the frequency domain analysis included: total power (area under the curve) over all frequencies, very low frequency (VLF, 0-0.04 Hz),low frequency (LF, 0.04-0.15 Hz), and high frequency (HF,0.15-0.4 Hz).|baseline and at end of a 4-week intervention|A data card failure of the baseline heart rate record with the VivoMetrics system occurred for one subject who had completed baseline and 4-week assessments, leaving 28 subjects (n=13 in placebo, n=15 in pregabalin)having both completed baseline and end of 4-week R-R intervals for heart rate variability analysis.||Hertz (Hz)||Standard Deviation|Mean
752900|NCT00573261|Primary|Assessing the Change in Heart Rate by Means of the LifeShirt System Upon Treatment of Pregabalin vs. Placebo in Patients With Diabetes and Peripheral Neuropathy.|The LifeShirt System, developed by VivoMetrics, is a lightweight vest with embedded sensors that continuously collect information on a range of cardiopulmonary parameters. It was used to collect and store the respiratory rate, posture, activity level, QRS complexes, and R-R intervals via a 3-axis accelerometer and a 3-lead, single channel electrocardiogram.|baseline and at end of a 4-week intervention|A data card failure of the baseline heart rate record with the VivoMetrics system occurred for one subject who had completed baseline and 4-week assessments, leaving 28 subjects (n=13 in placebo, n=15 in pregabalin)having both completed baseline and end of 4-week R-R intervals for heart rate variability analysis.||Beats Per Minute||Standard Deviation|Mean
752901|NCT00573261|Secondary|To Assess the Change of Pain Symptoms Upon Treatment of Pregabalin in Comparison to Placebo.|Pain severity was evaluated using the Visual Analog Scale, the Modified Brief Pain Inventory-Short Form, and the Neuropathy Pain Scale. The Visual Analog Scale was scored within a range of 0-100 with 0=no pain and 100=the worst imaginable pain. The Brief Pain Inventory is made up of two parts: total pain and pain interference. The total pain score is the sum of most, least, average, and now pain scored within a range of 0-10 with 0=no pain and 10=pain as bad as you can imagine. The pain interference score is the sum of affective and activity interference - how pain interfered with general activity, mood, walking ability, normal work, relationships, sleep, and enjoyment of life. It was scored within a range of 0-10 with 0=pain does not interfere and 10=pain completely interferes. The Neuropathy Pain Scale total is the sum of 10 items -cold, sharp, deep, dull, hot, intense, itchy, sensitive, surface, and unpleasant pain scored within a range of 0-10 with 0=no pain and 10=most pain.|baseline and end of 4 week intervention|A data card failure of the baseline heart rate record with the VivoMetrics system occurred for one subject who had completed baseline and their 4-week assessments, leaving 28 subjects (n=13 in placebo, n=15 in pregabalin)having both completed baseline and end of 4-week R-R intervals for heart rate variability analysis.||units on a scale||Standard Deviation|Mean
752902|NCT00573261|Primary|Assessing the Change in Resting Blood Pressure Upon Treatment of Pregabalin vs. Placebo in Patients With Diabetes and Peripheral Neuropathy.||baseline and at end of a 4-week intervention|A data card failure of the baseline heart rate record with the VivoMetrics system occurred for one subject who had completed baseline and 4-week assessments, leaving 28 subjects (n=13 in placebo, n=15 in pregabalin)having both completed baseline and end of 4-week R-R intervals for heart rate variability analysis.||mm Hg||Standard Deviation|Mean
752903|NCT00573287|Secondary|Psychiatric Symptoms Measured Using the Brief Psychiatric Rating Scale, Clinical Global Inventory, and Schedule for the Assessment of Negative Symptoms at Baseline and Then at Weeks 4, 8, 12, 16, 20, and 24.||24 weeks||||||
752904|NCT00573287|Primary|Number of Participants Demonstrating Improvement in Substance Use|"Based on the small sample size, it was not possible to test the differences between the two groups for statistical significance. Data on cannabis use was gathered weekly using the TLFB method. At the end of the study, graphs were plotted showing days of cannabis use per week and rated as “Improved,” “Unchanged,” or “Worse” by a pair of expert judges. Raters were instructed to rate the graph “Improved” or “Worsened” if it appeared to be >20% better or worse and to rate it Unchanged if there was little or no change (less than ~20%)."|24 weeks|Analysis was conducted for participants who were randomized to study medciation condition and actually began treatment with study drug and had a follow-up visit. Two patients (one in the Clozapine group and one in the Risperidone group) did not meet this criteria and were not included i the analysis.||participants|||Number
752905|NCT00573313|Secondary|Changes in Serum SAM|We compared serum levels of SAM at time 0 and week 24 of the study in the alcoholic liver disease groups only, since these parameters were measured in the healthy and lifestyle coaching groups only at baseline.|September 2005- June 2009|Whereas 37 subjects started the protocol, due to protocol violation, there remained 26 subjects, 13 in each group, for final analyses. Here are reported changes in AST values to represent all variables.||nmol/liter||Full Range|Median
752906|NCT00573313|Primary|Changes in Serum AST Levels|Biochemical values for liver function tests and histopathology scores were obtained at week 0 and 24 of the treatment trial, and changes in each were recorded. Here are reported changes in aspartate transaminase (AST) as representative of all changes. Since only baseline values were obtained in the Healthy and Lifestyle counseling groups, there are no recorded changes in these two groups.|Week 0 to week 24|Analysis of AST values was based on numbers of participants in each group who completed the study. Analysis is pre-specified to apply only to subjects with alcoholic liver disease.||Units per liter (U/L)||Full Range|Median
752907|NCT00573391|Primary|Participant Survival With Velcade/Melphalan/Dexamethasone Treatment vs. Participant Survival With Velcade/Thalidomide/Dexamethasone Treatment|due to low accrual rates, no analyses was done to compare the new combination of Velcade/Melphalan/Dexamethasone vs. Velcade/Thalidomide/Dexamethasone|24 months|||Participant|||Number
752908|NCT00573430|Secondary|Treatment-emergent Adverse Events|Prevalence of adverse events after treatment regardless causality. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition from the signing of the informed consent, whether or not considered causally related to the product.|Baseline to 28 weeks|||Participants|||Number
752909|NCT00573430|Secondary|Estimated GFR Predicted From the Modification of Diet in Renal Disease (MDRD) Equation|GFR (mL/min/1.73 m2) = 186 x (Scr)-1.154 x (Age)-0.203 x (0.742 if female) x (1.210 if African-American) (conventional units)|28 weeks|||mL/min/1.73 m2||Standard Deviation|Mean
752910|NCT00573430|Secondary|Inflammatory Marker (Hs-C-peptide Reactive Protein)|To evaluate how to reduce and relate with cardiovascular risk|baseline to 28 weeks|||mg/dL||Standard Deviation|Mean
752913|NCT00573443|Secondary|Mean Change From Baseline to Day 84 in Pain Rating Scale (PRS) of MS Subjects|Subjects with MS were instructed to also record daily the pain they experienced using the PRS. After evaluating the subject's ability to comply with these requirements, the investigator determined if a caregiver should complete the study diary and assessments. Subjects rated their pain over the past 12 hours on a scale of 0 to 10 (0=none, 10=worst pain ever experienced).|Baseline, Day 15, Day 29, Day 57, Day 84|ITT Population - MS Subjects only||Scores on a Scale||Standard Deviation|Mean
752914|NCT00573443|Secondary|Mean Change From Baseline at Day 84 in Beck Depression Inventory (BDI-II) Total Score|The BDI-II is a 21-item self report instrument intended to assess the existence and severity of symptoms of depression, summed to give a single score. The BDI-II uses a 4-point for each item ranging from 0 to 3. A total score of 0-13 is considered minimal range, 14 to 19 is mild, 20 to 28 is moderate, and 29 to 63 is severe.|Baseline and Day 84|ITT Population||Scores on a Scale||Standard Deviation|Mean
752915|NCT00573443|Secondary|Mean Change From Baseline at Day 84 in SF-36 (Short-Form) Health Survey Medical Outcome Score by Category|The SF-36 is designed to examine a person’s perceived health status. The SF-36 includes one multi-item scale measuring eight health concepts: vitality, physical functioning, bodily pain, general health perceptions, physical role-, emotional role-, social role functioning, and mental health. Answers to each question are scored and summed to produce raw scale scores for each health concept which are then transformed to a 0 – 100 scale, a high score defining a more favorable health state. An aggregate summary measure is calculated by averaging the scores from the eight health concepts.|Baseline and Day 84|ITT Population||Scores on a Scale||Standard Deviation|Mean
752916|NCT00573443|Secondary|Mean Change From Baseline to Day 84 in Neuropsychiatric Inventory (NPI-Q) Frequency and Severity Score (ITT Population)|The NPI is a retrospective (to 1 month) caregiver-informant interview assessing frequency and severity of 12 neuropsychiatric symptom domains. The NPI score is based on the sum of the severity ratings (0=absent, 1=mild, 3=severe). The 12 symptom domains include delusions, hallucinations, agitation/aggression, dysphoria/depression, anxiety, euphoria/elation, apathy/indifference, disinhibition, irritability/lability, aberrant motor behaviors, nighttime behavioral disturbances, and appetite/eating abnormalities. The NPI severity score is based on severity ratings (0=absent, 1=mild to 3=severe).|Baseline to Day 84|ITT Population||Scores on a Scale||Standard Deviation|Mean
752917|NCT00573443|Secondary|Mean Change From Baseline to Day 84 in Neuropsychiatric Inventory (NPI-Q) Frequency and Severity Score (EE Population)|The NPI is a retrospective (to 1 month) caregiver-informant interview assessing frequency and severity of 12 neuropsychiatric symptom domains. The NPI score is based on the sum of the severity ratings (0=absent, 1=mild, 3=severe). The 12 symptom domains include delusions, hallucinations, agitation/aggression, dysphoria/depression, anxiety, euphoria/elation, apathy/indifference, disinhibition, irritability/lability, aberrant motor behaviors, nighttime behavioral disturbances, and appetite/eating abnormalities. The NPI severity score is based on severity ratings (0=absent, 1=mild to 3=severe).|Baseline to Day 84|Efficacy Evaluable (EE) Population - included all subjects who were protocol adherent, defined as those who completed the Day 84 visit or the end-of-study visit within 48 hours of a discontinuation, and who took as least 80% of their scheduled doses prior to discontinuation of the study medication.||Scores on a Scale||Standard Deviation|Mean
752918|NCT00573443|Secondary|Mean Change From Baseline in CNS-LS Total Score by Visit|Center for Neurologic Studies-Lability Scale (CNS-LS) is an instrument for the measurement of PBA that has been validated for the use in patients with ALS and MS. It is a 7-item self-report questionnaire that measures the frequency and severity of PBA episodes, including assessments of labile laughter and labile tearfulness,and provides a score for total PBA (total score can range from 7-35). The following 5-point scoring was used: 1=Applies never, 2=Applies rarely, 3=Applies occasionally, 4=Applies frequently, 5=Applies most of the time. A score of 13 or higher may suggest PBA, and the higher the score the more severe the episodes.|Baseline, Day 15, Day 29, Day 57, Day 84|ITT Population||Scores on a Scale||Standard Deviation|Mean
752919|NCT00573443|Primary|PBA Episode Rate Ratio (Post/Pre), Regression Adjusted|Episodes were counted each day and recorded in a daily diary. The outcome measure is the ratio of the episode rate over the 84-day treatment period to the rate during the baseline period, adjusted for study site, and underlying disease using longitudinal negative binomial regression.|Baseline to Day 84|Intent-to-Treat (ITT) population - included all randomized subjects for the double-blind phase and all enrolled subjects for the open-label extension phase.||Unit-free (ratio of episodes/week)||95% Confidence Interval|Least Squares Mean
752920|NCT00573469|Secondary|Change in CDAI Score From Baseline to 8 Weeks|CDAI score is an index showing the condition of Crohn's disease and has no unit. The minimum is 0 and the maximum is not defined. Higher score shows worse condition and a decrease in score means improvement. In this study, participants who had 200 or higher of CDAI score were enrolled. The change from baseline to 8 weeks in CDAI score was measured.|Baseline to 8 weeks|||Score on a scale||Standard Deviation|Mean
752921|NCT00573469|Secondary|Cumulative Percentage of Participants Who Achieved Remission up to 8 Weeks by Kaplan-Meier Method|Time from randomisation to the remission of Crohn's disease defined as CDAI score  150 was analysed by Kaplan-Miere method. From this method, the cumulative percentage of participants who obtained up to 8 weeks were obtained.|At 8 weeks|||Percentage of participants|||Number
752922|NCT00573469|Secondary|Number of Participants Who Had Remission of Crohn's Disease After 4-week Treatment|The number of participants who had remission of Crohn's disease (i.e., CDAI score ≤ 150) after 2-week treatment was one of the secondary measures of this study.|Baseline to 4 weeks|||Participants|||Number
752923|NCT00573469|Secondary|Number of Participants Who Had Remission of Crohn's Disease After 2-week Treatment|The number of participants who had remission of Crohn's disease (i.e., CDAI score ≤ 150) after 2-week treatment was one of the secondary measures of this study.|Baseline to 2 weeks|||Participants|||Number
752924|NCT00573469|Primary|Number of Participants Who Had Remission of Crohn's Disease After 8-week Treatment|Remission is defined by a Crohn's Disease Activity Index (CDAI) score of ≤ 150. That is, if a participant had 150 or less of CDAI score after 8-week treatment, the participant had the remission of Crohn's disease. The number of participants who had remission of Crohn's disease after 8-week treatment was the primary measure of this study.|Baseline to 8 weeks|||Participants|||Number
752989|NCT00565409|Secondary|General Health at Week 36|"General Health VAS is a 100 mm line marked by the participant. Participants are asked, In general how would you rate your health over the last 2 to 3 weeks? Scores ranged from 0 mm = very well to 100 mm = extremely bad."|Week 36|P2 mITT; LOCF||mm||Standard Error|Mean
752925|NCT00573508|Secondary|Change From Baseline to End of Treatment in Mean Parameters Per 24 Hours Recorded in 3-day Diary|"The mean parameters recorded for previous 24 hours in the 3-day diary were: number of micturitions, number of incontinence episodes, number of urgency episodes, number of nocturia episodes and number of nocturnal voids.
Change from baseline with a lower score indicates an improvement.
End of Treatment (EOT) results include patients who had early discontinuation from the study; only patients who had the symptom at baseline and data at the EOT in the 3-day diary are included in the data table.
Change is calculated as EOT - Baseline"|Baseline and 12 Weeks|"Population is full analysis set(FAS): all randomized patients who took at least 1 dose of double-blind study drug & had an OAB-q assessment at both baseline & at least 1 post-baseline visit.
The number of participants analyzed per arm represents FAS. The number of participants for each timepoint / parameter are noted in the category titles."||Number of Category Events / 24 Hours||Standard Deviation|Mean
752926|NCT00573508|Secondary|Change From Baseline in the Treatment Satisfaction Visual Analog Scale (TS-VAS)|"The TS-VAS is a instrument utilized to further evaluate the effect of solifenacin succinate on patients' overall satisfaction & quality of life. Each patient completed a TS-VAS to rate satisfaction with treatment. They were to answer the following question: Are you satisfied with your treatment? by placing a mark on a line that ran from 0 (no, not at all) to 100 (yes, completely).
Change from baseline with a positive score indicates an improvement. The End of Treatment (EOT) results include patients who had early discontinuation from the study.
Change is calculated as EOT - Baseline"|Baseline and 12 Weeks|"Population is full analysis set(FAS): all randomized patients who took at least 1 dose of double-blind study medication and had an assessment in OAB-q at both baseline and at least 1 post-baseline visit.
The number of participants analyzed per arm represents FAS. The numbers of participants for each row are noted in the category titles."||TS-VAS||Standard Deviation|Mean
752927|NCT00573508|Secondary|Change From Baseline in International Consultation on Incontinence Modular Questionnaire Female Sexual Matters Associated With Lower Urinary Tract Symptoms (ICIQ-FLUTSsex)Overall Symptom and Bother Scores.|"ICIQ-FLUTSsex is a patient reported outcome instrument to further evaluate the effect of solifenacin succinate on patients' overall satisfaction & quality of life.The questionnaire contains 5 questions for detailed evaluation of sexual matters associated with lower urinary track symptoms & impact on sexual quality of life, with a scale of 0 to 14.
Change from baseline with a negative score indicates improvement. End of Treatment results include patients who had early discontinuation. Change is calculated as End of Treatment(EOT)-Baseline."|Baseline and 12 Weeks|"Population is full analysis set(FAS): all randomized female patients who took at least 1 dose of double-blind study medication and had an assessment in OAB-q at both baseline and at least 1 post-baseline visit.
The number of participants analyzed per arm represents FAS. The numbers of participants for each visit are noted in the category titles."||ICIQ-FLUTSsex||Standard Deviation|Mean
752928|NCT00573508|Secondary|Change From Baseline in International Consultation on Incontinence Modular Questionnaire Male Sexual Matters Associated With Lower Urinary Tract Symptoms (ICIQ-MLUTSsex) Overall Symptom and Bother Scores.|"ICIQ-MLUTSsex is a patient reported outcome instrument to further evaluate the effect of solifenacin succinate on patients' overall satisfaction & quality of life. The questionnaire contains 5 questions for detailed evaluation of sexual matters associated with lower urinary track symptoms & impact on sexual quality of life, with a scale of 0 to 12.
Change from baseline with a negative score indicates improvement. End of Treatment results include patients who had early discontinuation. Change is calculated as End of Treatment(EOT)-Baseline."|Baseline and 12 Weeks|"Population is full analysis set(FAS): all randomized male patients who took at least 1 dose of double-blind study medication and had an assessment in OAB-q at both baseline and at least 1 post-baseline visit.
The number of participants analyzed per arm represents FAS. The numbers of participants for each visit are noted in the category titles."||ICIQ-MLUTSsex||Standard Deviation|Mean
752929|NCT00573508|Secondary|Change From Baseline in the MCUI Behavior Therapy Stratified|"MCUI is a Patient Reported Outcome instrument utilized to further evaluate the effect of solifenacin succinate on patient's overall satisfaction and quality of life. The tool included questions concerning the effect of the patients bladder condition on access to medical care.
A negative score in Change from Baseline indicates improvement.
End of Treatment results include patients who had early discontinuation from the study.
Change is calculated as End of Treatment (EOT) - Baseline"|Baseline and 12 Weeks|Population is full analysis set(FAS):all randomized patients who took at least 1 dose of double-blind study medication & had an assessment in OAB-q at both baseline & at least 1 post-baseline visit. The number of participants analyzed per arm represents FAS. The numbers of participants for each timepoint/ parameter are noted in the category titles.||Number of Days||Standard Deviation|Mean
752930|NCT00573508|Secondary|Change From Baseline in the Medical Care Use Index (MCUI) Medical Resource Utilization in the Past 3 Months|"MCUI is a Patient Reported Outcome instrument utilized to further evaluate the effect of solifenacin succinate on patient's overall satisfaction and quality of life.The tool included questions concerning the effect of the patients bladder condition on access to medical care.
A negative score in Change from Baseline indicates improvement.
End of Treatment results include patients who had early discontinuation from the study.
Change is calculated as End of Treatment (EOT) - Baseline"|Baseline and 12 Weeks|Population is full analysis set(FAS):all randomized patients who took at least 1 dose of double-blind study medication & had an assessment in OAB-q at both baseline & at least 1 post-baseline visit. The number of participants analyzed per arm represents FAS. The numbers of participants for each timepoint/ parameter are noted in the category titles.||Number of categorical items||Standard Deviation|Mean
752931|NCT00573508|Secondary|Change From Baseline in Work Productivity Assessment Index (WPAI)|"The WPAI is a tool used to evaluate the effect of solifenacin succinate on a patient's overall satisfaction & quality of life, and included 6 questions regarding the effect that bladder condition had on ability to perform work-related functions & carry out daily activities over the past 4 weeks. The scores were converted to percentages for reporting.
A negative score in Change from Baseline indicates improvement. End of Treatment results include patients who had early discontinuation from the study.
Change from baseline is based on the ANCOVA model after adjusting baseline value & center."|Baseline and 12 Weeks|"Population is full analysis set (FAS): all randomized patients who took at least 1 dose of double-blind study drug & had an OAB-q assessment at both baseline & at least 1 post-baseline visit.
The number of participants analyzed per arm represents FAS. The numbers of participants for each timepoint / parameter are noted in the category titles."||Percentage of indicated parameter||Standard Deviation|Mean
752932|NCT00573508|Secondary|Change From Baseline to Each Visit in the OAB-q HRQL Sub-domain Scores of Coping, Concern, Sleep and Social|"The OAB-q is used to assess how much a patient is bothered by OAB symptoms & the impact on the patient's HRQL. It is comprised of 33 items, with raw scores for each sub-domain being converted to a scale of 0 to 100.
Higher score values are indicative of better HRQL, and a positive score in change from baseline indicates improvement.
Change is calculated End of Treatment (EOT) for each sub-domain – Baseline."|Baseline, Week 4, Week 8 and Week 12|"Population is full analysis set(FAS): all randomized patients who took at least 1 dose of double-blind study medication and had an assessment in OAB-q at both baseline and at least 1 post-baseline visit.
Number of participants analyzed per arm represents FAS. The numbers of participants for each visit/sub domain are noted in the category titles."||OAB-q HRQL Sub Domain Score||Standard Deviation|Mean
752933|NCT00573508|Secondary|Patient Perception of Treatment Benefit at the End of Treatment in the Global Assessment Score of the Benefit, Satisfaction, and Willingness (BSW) Questionnaire|The BSW questionnaire is a validated instrument that can be used to assess patient satisfaction with antimuscarinic agents for OAB. It is designed to capture the patient's perception of the effect of treatment in terms of relative benefit, patient satisfaction, and patient intention or willingness to continue on therapy.|Baseline and 12 Weeks|"The number assessed included all participants who completed the BSW questionnaire at baseline visit (visit 2) and end of treatment (visit 5/early withdrawal).
A few patients who completed the BSW Questionnaire did not adequately complete the  Benefits Section and therefore are considered 'N/A' for that Section."||Participants|||Number
752934|NCT00573508|Secondary|Number of Participants With Change From Baseline in the Global Assessment Score of the Patient Perception of Bladder Condition (PPBC)|"The PPBC is a validated, global assessment tool using a 6-point Likert scale which requires patients to assess their bladder condition by selecting one of the following responses: 1=Does not cause me any problem at all; 2=Cause me some very minor problems; 3=Causes me some minor problems; 4=Causes me (some) moderate problems; 5=Causes me severe problems; 6=Causes me many severe problems
Improvement is defined by any reduction in PPBC score.
End of Treatment results include patients who had early discontinuation from the study.
Change is calculated as End of Treatment (EOT) - Baseline"|Baseline and 12 Weeks|Population is full analysis set(FAS): all randomized patients who took at least 1 dose of double-blind study medication and had an assessment in OAB-q at both baseline and at least 1 post-baseline visit.||Participants|||Number
752935|NCT00573508|Secondary|Change From Baseline to Each Visit in OAB-q Health Related Quality of Life (HRQL) Total Score|"The OAB-q is used to assess how much a patient is bothered by OAB symptoms and the impact of these symptoms on the patient's HRQL. It is a validated patient administered tool comprised of 33 items, where items 9 - 33 define HRQL with raw score being converted to a scale of 0 to 100.
Higher score values are indicative of better HRQL, and a positive score in change from baseline indicates improvement.
Change is calculated as Actual Data for each time point - Baseline."|Baseline, Week 4, Week 8 and Week 12|"Population is full analysis set(FAS): all randomized patients who took at least 1 dose of double-blind study medication and had an assessment in OAB-q at both baseline and at least 1 post-baseline visit.
The number of participants analyzed per arm represents FAS. The numbers of participants for each visit are noted in the category titles."||OAB-q HRQL Total Score||Standard Deviation|Mean
752936|NCT00573508|Secondary|Change From Baseline to Each Visit in Symptom Bother Utilizing the OAB-q Score|"The OAB-q is used to assess how much a patient is bothered by OAB symptoms and the impact of these symptoms on the patient's HRQL. It is a validated patient administered tool comprised of 33 items, where the first 8 items define symptom bother with raw score being converted to a scale of 0 to 100.
Higher score values are indicative of greater symptom severity or bother, and a lower score in change from baseline indicates improvement.
Change is calculated as Actual Data for each timepoint - Baseline."|Baseline, Week 4, Week 8 and Week 12|"Population is full analysis set(FAS): all randomized patients who took at least 1 dose of double-blind study medication and had an assessment in OAB-q at both baseline and at least 1 post-baseline visit.
The number of participants analyzed per arm represents FAS. The numbers of participants for each visit are noted in the category titles."||OAB-q Score||Standard Deviation|Mean
752937|NCT00573508|Primary|Change From Baseline to End of Treatment in Overactive Bladder Questionnairre (OAB-q) Symptom Bother Score|"The OAB-q is used to assess how much a patient is bothered by OAB symptoms & the impact of these symptoms on the patient's Health Related Quality of Life(HRQL). It is a patient administered tool comprised of 33 items, where the first 8 define symptom bother with raw score being converted to a scale of 0 to 100.
Higher score values are indicative of greater symptom severity or bother, and a lower score in change from baseline indicates improvement.
End of Treatment results include patients who had early discontinuation from the study.
Change is calculated as End of Treatment - Baseline."|Baseline and 12 Weeks|"Population is full analysis set(FAS): all randomized patients who took at least 1 dose of double-blind study medication and had an assessment in OAB-q at both baseline and at least 1 post-baseline visit.
The number of participants per arm is consistent for all categories / rows of the data table."||OAB-q Score||Standard Deviation|Mean
752938|NCT00573534|Secondary|Number of Participants With Low or no Substance Use During the Study vs the Number With Intermittent Use Judged by (1)Time Line Follow Back (Confidential Clinician Administered Record of Recent Substance Use) (2) Urine Toxicology.|This outcome measure integrates data from self report supplied in the Time Line Follow Back (a self report summary of all substance and alcohol use over the previous week or month) with evidence from periodic (weekly to monthly) urine toxicologies.|up to 24 weeks|The 8 subjects who took at least one dose of the medication and returned for follow up were included.||participants|||Number
752939|NCT00573534|Primary|Number of Participants With at Least 70% Reduction in ADHD Symptoms as Measured by Change in ADHD Rating Scale From First to Last Visit|The outcome is the number of subjects who achieved a clinically meaningful reduction in ADHD symptoms. This is defined as a 70% reduction from baseline as measured by change in the ADHD Rating Scale (ADHD-RS). The ADHD RS quantifies symptoms on a 0-3 scale, 0 meaning never present, 1 sometimes, 2 often present, 3 very often present. For this study, the scale was clinician administered using both parent and adolescent to achieve a consensus score, or a best estimate on the clinician's part when consensus could not be achieved|up to 24 weeks|All patients who agreed to participate. Last Observation Carried Forward was used final outcome.||participants|||Number
755305|NCT00593606|Primary|Change in Serum Glutamic Oxaloacetic Transaminase|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||Units/l||Standard Deviation|Mean
752940|NCT00565058|Secondary|Summary of Treatment Emergent Adverse Events|An adverse event (AE) was defined as any unintended or undesirable experience that occurred during the course of the clinical investigation, regardless of whether or not it was considered to be study drug-related. This included any newly occurring event or a previous condition that had increased in severity or frequency since the administration of study drug.|30 days after the last dose|All Treated Patients population.||participants|||Number
752941|NCT00565058|Primary|Overall Response Rate of GTI-2040 Combined With HiDAC in Refractory or Relapsed AML|Overall Response was defined as whether or not the patient achieved complete remission (CR) and CR with incomplete blood count recovery (CRi) while on the study.|at 29-35 days|All Treated Patients population||participants|||Number
752942|NCT00565084|Primary|Change in Average Pain Intensities Measured From the Pre-Treatment Walk (Baseline) at 3 Post-Treatment Walks|"Pain intensities(PIs) were measured at pre-dose and 3 post-dose walks (15 Minutes Each Separated by a 45-Minute Rest Interval) on an 11 point scale(0=no pain; 10=worst pain) and averaged for each walk.
Change from baseline was average of post-dose PIs minus average of pre-dose PI."|All pain intensities measured from the pre-treatment walk and 3 post-treatment walks (within 3 and half hours post dose, 15 minutes each walk separated by a 45-minute rest interval)|This is a crossover study. Total number of participants was 33; every participant had one ibuprofen period and two placebo periods.||Units on a Scale||Standard Deviation|Least Squares Mean
752943|NCT00565110|Secondary|Physical Composite Summary Score (PCS) Derived From the 12-item Short Form (SF-12) Health Survey|The SF-12 measures 8 health domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. PCS is a summary score measuring physical health derived by summing responses across scale items and then transforming to a 0-100 scale (higher scores indicate better health).|12 months|||units on a scale||Standard Error|Mean
752944|NCT00565110|Primary|Reduced Depression Symptoms|Number of participants with 50% PHQ-9 score reduction since baseline|12 months|||Participants|||Count of Participants
752945|NCT00565136|Other Pre-specified|Pudendal Nerve Terminal Motor Latency|Pudendal Nerve Terminal Motor Latency is a measure of the time it takes for stimulation of the pudendal nerve to elicit contraction of the pelvic floor muscles and anal sphincter. It is a surrogate marker of pudendal nerve injuries and a means of ascertaining whether anal sphincter weakness is attributable to pudendal nerve injury, sphincter defect, or both.|Baseline (pre-treatment), 6 Month post-treatment|||msec||Standard Deviation|Mean
752946|NCT00565136|Other Pre-specified|Anal Manometry: Maximum Tolerable Volume||Baseline (pre-treatment), 6 Month post-treatment|||cc||Standard Deviation|Mean
752947|NCT00565136|Other Pre-specified|Anal Manometry: Rectal First Sensation||Baseline (pre-treatment), 6 Month post-treatment|||cc||Standard Deviation|Mean
752948|NCT00565136|Other Pre-specified|Anal Manometry: Maximum Squeeze Pressure||Baseline (pre-treatment), 6 Month post-treatment|||mmHg||Standard Deviation|Mean
752949|NCT00565136|Other Pre-specified|Anal Manometry: Maximum Resting Pressure||Baseline (pre-treatment), 6 Month post-treatment|||mmHg||Standard Deviation|Mean
752950|NCT00565136|Secondary|Intra- and Peri-Surgical Parameters: Estimated Blood Loss During Implant Procedure||Duration of the device implant procedure (an average of 23 minutes)|All enrolled/implanted subjects were included in this analysis||ml||Standard Deviation|Mean
752951|NCT00565136|Secondary|Intra- and Peri-Surgical Parameters: Length of Hospital Stay||Length of the hospital stay for the device implant procedure|All enrolled/implanted subjects were included in this analysis||hours||Standard Deviation|Mean
752952|NCT00565136|Secondary|Intra- and Peri-Surgical Parameters: Length of Procedure||Duration of the device implant procedure|All enrolled/implanted subjects were included in this analysis||minutes||Standard Deviation|Mean
752953|NCT00565136|Secondary|Pain Intensity as Measured by the Pain Intensity Scale|The Pain Intensity Scale is a subject completed questionnaire. Scores are measured on 0 (no pain) to 10 (worst possible pain) scale.|Baseline (pre-treatment), 6 Week post-treatment|"The Pain Intensity Scale was completed by the number of subjects at each visit as follows:
Baseline: N=29, 6 Week: N=29"||units on a scale||Standard Deviation|Mean
752954|NCT00565136|Secondary|Quality of Life Assessment as Measured by Fecal Incontinence Quality of Life|The Fecal Incontinence Quality of Life Assessment is a subject-completed questionnaire. It is measured in each of four areas of depression (7 items), lifestyle (10 items), coping (9 items), and embarrassment (3 items). Area scores are measured on a 1 (worse) to 4 (best) scale and are each the average of their component individual item scores measured on the same scale.|Baseline (pre-treatment), 3 Month, 6 Month, 12 Month and 24 Month post-treatment|"The Fecal Incontinence Quality of Life Assessment was completed by the number of subjects at each visit as follows:
Baseline: N=29, 3 Month: N=26, 6 Month: N=25, 12 Month: N=25, 24 Month: N=23"||units on a scale||Standard Deviation|Mean
752955|NCT00565136|Post-Hoc|Percentage of Subjects With Greater Than or Equal to a 50 Percent Reduction in FI Episodes From Baseline|Includes solid and liquid stools, as measured by a subject-reported bowel diary|6 Weeks, 3 Month, 6 Month, 12 Month and 24 Month post-treatment|"Two subjects were enrolled who recorded no FI episodes at baseline and were excluded from this analysis. Missing data was not imputed and was considered a treatment failure.
The Bowel Diary was completed by the number of subjects at each visit as follows:
6 Week: N=24, 3 Month: N=25, 6 Month: N=22, 12 Month: N=21, 24 Month: N=24"||percentage participants||90% Confidence Interval|Number
752956|NCT00565136|Secondary|Fecal Incontinence Symptoms as Measured by Symptom Severity Scale in Fecal Incontinence|The Symptom Severity Scale in Fecal Incontinence is a subject-completed questionnaire that asks about the symptoms of fecal incontinence in the following areas: frequency, stool composition, stool amount, and degree of urgency. The total score is measured on a 0 (best) to 13 (worst) scale. Scores of 1–6, 7–10, and 11–13 were categorized as mild, moderate, and severe fecal incontinence, respectively.|Baseline (pre-treatment), 6 Week, 3 Month, 6 Month, 12 Month and 24 Month post-treatment|"The Symptom Severity Scale in Fecal Incontinence was completed by the number of subjects at each visit as follows:
Baseline: N=29, 6 Week: N=29, 3 Month: N=26, 6 Month: N=25, 12 Month: N=25, 24 Month: N=23"||units on a scale||Standard Deviation|Mean
752990|NCT00565409|Secondary|Change From Baseline in General Health at Weeks 4, 8, 12, 20, 28 and 36|"General Health VAS is a 100 millimeter (mm) line marked by the participant. Participants were asked, In general how would you rate your health over the last 2 to 3 weeks? Scores ranged from 0 mm = very well to 100 mm = extremely bad. Change = Week X observation - Baseline observation."|Baseline, Weeks 4, 8, 12, 20, 28 and 36|P1 mITT; N=number of participants with evaluable data; LOCF||mm||Standard Deviation|Mean
752957|NCT00565136|Secondary|Fecal Incontinence Symptoms as Measured by the Wexner Score|The Wexner Score (also known as the Cleveland Clinic Florida Incontinence Score) is a subject-completed questionnaire that asks about the frequency of incontinence to gas, liquid, solid, of the need to wear pads, and of lifestyle changes (scored on a frequency scale from 0 (=absent) to 4 (daily). An overall Wexner Score is computed from these five components and a score of 0 means perfect control and 20 means complete incontinence.|Baseline (pre-treatment), 6 Week, 3 Month, 6 Month, 12 Month and 24 Month post-treatment|"The Wexner Score was completed by the number of subjects at each visit as follows:
Baseline: N=29, 6 Week: N=29, 3 Month: N=26, 6 Month: N=25, 12 Month: N=25, 24 Month: N=23"||units on a scale||Standard Deviation|Mean
752958|NCT00565136|Secondary|Incidence Rate of Complications During the 24 Month Post-Treatment Follow-up Period|Complications are defined as all adverse events reported during the 24 month follow-up period including serious/non-serious events and events related/not related to the device and/or procedure. Incidence rate is calculated as: (total number of adverse events reported in the 24 month follow-up period) / (total number of subjects implanted = 29)|Through 24 month post-treatment|Includes all subjects implanted with the TOPAS device||events per 24 months/participant|||Number
752959|NCT00565136|Primary|Fecal Incontinence Incidence From Baseline (Pre-treatment) Through 24 Months Post-treatment|Includes solid and liquid stools, as measured by the mean rate obtained using a subject-reported bowel diary. The 3 month post-treatment visit was the primary endpoint time period.|Baseline (pre-treatment), 6 Week, 3 Month, 6 Month, 12 Month and 24 Month post-treatment|"The FI Bowel Diary was completed by the number of subjects at each visit as follows:
Baseline: N=29, 6 Week: N=26, 3 Month: N=27, 6 Month: N=24, 12 Month: N=23, 24 Month: N=26"||Number of FI episodes/14 day period||Standard Deviation|Mean
752960|NCT00565266|Secondary|Adverse Events||Measured during each of the three 14-week treatment periods||||||
752961|NCT00565266|Secondary|Biomarkers of Inflammation and Oxidative Stress||Measured during each of the three 14-week treatment periods||||||
752962|NCT00565266|Secondary|Asthma Exacerbations||Measured during each of the three 14-week treatment periods||||||
752963|NCT00565266|Secondary|Asthma Control, Asthma Quality-of-life||Measured during each of the three 14-week treatment periods||||||
752964|NCT00565266|Secondary|Asthma Symptoms, Number of Asthma-control Days, Rescue Inhaler Use||Measured during each of the three 14-week treatment periods||||||
752965|NCT00565266|Secondary|Forced Expiratory Volume in One Second (FEV1)||Measured during each of the three 14-week treatment periods||||||
752966|NCT00565266|Primary|Change Between Week 14 and Week 0 in the Morning (AM) Peak Expiratory Flow (PEF)||AM PEF was measured daily during each of the three 14-week treatment periods. The primary analysis constructed the change between week 14 and week 0.|All randomized participants were included in the linear mixed-effects model analysis||Liters per minute||Standard Error|Least Squares Mean
752967|NCT00565370|Secondary|Toxicity Profile (According to National Cancer Institute Common Terminology Criteria for Adverse Event Version 3.0)|Number of patients who experienced toxicity from study treatment to evaluate the safety and tolerability of Capecitabine and cisplatin plus sorafenib|28weeks|||participants|||Number
752968|NCT00565370|Secondary|Overall Survival||28 months|||Months||95% Confidence Interval|Median
752969|NCT00565370|Secondary|Response Rate|"Tumor response was assessed every two cycles by RECIST(v1.0) using the same imaging techniques and methods used at baseline.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR., or similar definition that is accurate and appropriate"|6 months|Patients who had measurable lesions were included for the response rates||percentage of participants||95% Confidence Interval|Number
752970|NCT00565370|Primary|Progression-free Survival||1 year|||Months||95% Confidence Interval|Median
752971|NCT00565370|Primary|Number of Participants Who Experienced Dose Limiting Toxicities (DLTs)|Number of Participants who Experienced Dose Limiting Toxicities (DLTs)|28weeks|||participants|||Number
752972|NCT00565409|Secondary|DAS28 at Week 36|The DAS28 is a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (>5.1=high disease activity; <=3.2=low disease activity; <2.6=remission); a continuous variable which is a composite of 4 variables (the number of tender joints out of 28, the number of swollen joints out of 28 joints, ESR mm/hour and PGA of disease activity measured on a VAS of 100 mm).|Week 36|P2 mITT; LOCF||units on a scale||Standard Error|Mean
752973|NCT00565409|Secondary|Percentage of Participants With an ACR90 Response at Weeks 36, 40, 48, 56, 64, 72, 80 and 88|ACR90 response: ≥ 90% improvement in tender joint count; = 90% improvement in swollen joint count; and = 90% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and acute phase reactant (ESR).|Weeks 36, 40, 48, 56, 64, 72, 80 and 88|P2 mITT; LOCF||percentage of participants|||Number
752974|NCT00565409|Secondary|Percentage of Participants With an ACR90 Response at Weeks 4, 8, 12, 20, 28 and 36|ACR90 response: ≥ 90% improvement in tender joint count; = ≥90% improvement in swollen joint count; and = at least 90% improvement in 3 of the following 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and acute phase reactant (ESR).|Weeks 4, 8, 12, 20, 28 and 36|P1 mITT; LOCF||percentage of participants|||Number
752975|NCT00565409|Secondary|Percentage of Participants With an ACR70 Response at Weeks 36, 40, 48, 56, 64, 72, 80 and 88|ACR70 response: ≥ 70% improvement in tender joint count; = ≥70% improvement in swollen joint count; and = at least 70% improvement in 3 of the following 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and C-Reactive Protein CRP.|Weeks 36, 40, 48, 56, 64, 72, 80 and 88|P2 mITT; N=number of participants with evaluable data; LOCF||percentage of participants|||Number
753033|NCT00565643|Primary|Adhesion Score|Adhesion score. Derived by assigning 1 point for filmy adhesion and 2 points for dense adhesions at each of 6 possible sites in the abdomen. Thus the score can range from 0 (i.e., no adhesions at any location) to 12 (dense adhesions at each site).|3 to 5 years|||units on a scale||Full Range|Median
752976|NCT00565409|Secondary|Percentage of Participants With an ACR70 Response at Weeks 4, 8, 12, 20, 28 and 36|ACR70 response: ≥ 70% improvement in tender joint count; = ≥70% improvement in swollen joint count; and = at least 70% improvement in 3 of the following 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and acute phase reactant (ESR).|Weeks 4, 8, 12, 20, 28 and 36|P1 mITT; N=number of participants with evaluable data; LOCF||percentage of participants|||Number
752977|NCT00565409|Secondary|Percentage of Participants With an ACR50 Response at Weeks 36, 40, 48, 56, 64, 72, 80 and 88|ACR50 response: ≥ 50% improvement in tender joint count; = ≥50% improvement in swollen joint count; and = at least 50% improvement in 3 of the following 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and acute phase reactant (ESR).|Weeks 36, 40, 48, 56, 64, 72, 80 and 88|P2 mITT; N=number of participants with evaluable data; LOCF||percentage of participants|||Number
752978|NCT00565409|Secondary|Percentage of Participants With an ACR50 Response at Weeks 4, 8, 12, 20, 28 and 36|ACR50 response: ≥ 50% improvement in tender joint count; = ≥50% improvement in swollen joint count; and = at least 50% improvement in 3 of the following 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and acute phase reactant (ESR).|Weeks 4, 8, 12, 20, 28 and 36|P1 mITT; N=number of participants with evaluable data; LOCF||percentage of participants|||Number
752979|NCT00565409|Secondary|Percentage of Participants With an ACR20 Response at Weeks 36, 40, 48, 56, 64, 72, 80 and 88|ACR20 response: ≥ 20% improvement in tender joint count; ≥20% improvement in swollen joint count; and = at least 20% improvement in 3 of the following 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and acute phase reactant (ESR).|Weeks 36, 40, 48, 56, 64, 72, 80 and 88|P2 mITT; LOCF; N=number of participants with evaluable data||percentage of participants|||Number
752980|NCT00565409|Secondary|Percentage of Participants With an American College of Rheumatology 20 Percent (%) (ACR20) Response at Weeks 4, 8, 12, 20, 28 and 36|ACR20 response, ≥ 20 percent (%) improvement in tender joint count; ≥ 20% improvement in swollen joint count; and = at least 20% improvement in at least 3 of the following 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant (ESR).|Weeks 4, 8, 12, 20, 28 and 36|P1 mITT; N=number of participants with evaluable data; LOCF||percentage of participants|||Number
752981|NCT00565409|Secondary|Percentage of Participants Achieving EULAR Good or Moderate Response at Week 36, 40, 48, 56, 64, 72, 80 and 88|EULAR Response Criteria: Good response was defined as >1.2 units improvement in DAS28 from Baseline and DAS28 attained up to Week 88 of <=3.2 units. Non responders were participants with improvement of <0.6 units or participants with improvement of 0.6 to 1.2 units and DAS28 attained up to Week 88 of > 5.1 units. Remaining participants were defined as having a moderate response. Scores of good and moderate were considered to have therapeutic response.|Week 36, 40, 48, 56, 64, 72, 80 and 88|P2 mITT; N=number of participants with evaluable data; LOCF||percentage of participants|||Number
752982|NCT00565409|Secondary|Percentage of Participants Achieving European League Against Rheumatism (EULAR) Good or Moderate Response at Weeks 4, 8, 12, 20, 28 and 36|EULAR Response Criteria: Good response was defined as >1.2 units improvement in DAS28 from Baseline and DAS28 attained up to Week 88 of <=3.2 units. Non responders were participants with improvement of <0.6 units or participants with improvement of 0.6 to 1.2 units and DAS28 attained up to Week 88 of > 5.1 units. Remaining participants were defined as having a moderate response. Scores of good and moderate were considered to have therapeutic response.|Weeks 4, 8, 12, 20, 28 and 36|P1 mITT; N=number of participants with evaluable data; LOCF||percentage of participants|||Number
752983|NCT00565409|Secondary|Percentage of Participants Achieving an Acceptable State on the PASS at Week 36 and Weeks 64 and 88|PASS was a 1 question assessment of how rheumatoid arthritis has affected the participant in the last 2 days (If you were to remain in the next few months as you were during the last 2 days, would this be acceptable or unacceptable to you?).|Weeks 36, 64 and 88|P2 mITT; N=number of participants with evaluable data; LOCF||percentage of participants|||Number
752984|NCT00565409|Secondary|Percentage of Participants Achieving an Acceptable State on the Patient Acceptable Symptom State (PASS) at Baseline and Week 36|PASS was a 1 question assessment of how rheumatoid arthritis has affected the participant in the last 2 days (If you were to remain in the next few months as you were during the last 2 days, would this be acceptable or unacceptable to you?).|Baseline, Week 36|P1 mITT; N=number of participants with evaluable data; LOCF||percentage of participants||95% Confidence Interval|Number
752985|NCT00565409|Secondary|Change From Week 36 in Pain at Weeks 40, 48, 56, 64, 72, 80 and 88|100 mm line (Visual Analog Scale) marked by participant. Intensity of pain range (over past 2 to 3 days): 0 = no pain to 100 = worst possible pain. Change = Week X observation - Week 36 observation.|Weeks 36, 40, 48, 56, 64, 72, 80 and 88|P2 mITT; LOCF||mm||Standard Error|Least Squares Mean
752986|NCT00565409|Secondary|Pain at Week 36|100 mm line (Visual Analog Scale) marked by participant. Intensity of pain range (over past 2 to 3 days): 0 = no pain to 100 = pain as bad as it could be. Change = Week x observation minus (-) Baseline observation.|Week 36|P2 mITT; LOCF||mm||Standard Error|Mean
752987|NCT00565409|Secondary|Change From Baseline in Pain at Weeks 4, 8, 12, 20, 28 and 36|100 mm line (Visual Analog Scale) marked by participant. Intensity of pain range (over past 2 to 3 days): 0 = no pain to 100 = worst possible pain. Change = Week X observation – Baseline observation.|Baseline, Weeks 4, 8, 12, 20, 28 and 36|P1 mITT; N=number of participants with evaluable data; LOCF||mm||Standard Error|Mean
752988|NCT00565409|Secondary|Change From Week 36 in General Health at Weeks 40, 48, 56, 64, 72, 80, 88|"General Health VAS is a 100 mm line marked by the participant. Participants were asked, In general how would you rate your health over the last 2 to 3 weeks? Scores ranged from 0 mm = very well to 100 mm = extremely bad. Change = Week X observation - Week 36 observation."|Weeks 36, 40, 48, 56, 64, 72, 80, 88|P2 mITT; N=number of participants with evaluable data; LOCF||mm||Standard Error|Least Squares Mean
752991|NCT00565409|Secondary|Change From Week 36 in Duration of Morning Stiffness at Weeks 40, 48, 56, 64, 72, 80, 88|Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness. No stiffness present = 0; stiffness persisted the entire day = 1440 minutes (24 hour * 60 min) was recorded. Change = Week X observation - Week 36 observation.|Weeks 36, 40, 48, 56, 64, 72, 80, 88|P2 mITT; N=number of participants with evaluable data; LOCF||min||Standard Error|Least Squares Mean
752992|NCT00565409|Secondary|Duration of Morning Stiffness at Week 36|Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and when the participants were able to resume normal activities without stiffness. No stiffness present = 0; stiffness persisted the entire day = 1440 minutes (24 hour * 60 min) was recorded.|Week 36|P2 mITT; N=number of participants with evaluable data; LOCF||min||Standard Error|Mean
752993|NCT00565409|Secondary|Change From Baseline in Duration of Morning Stiffness at Weeks 4, 8, 12, 20, 28 and 36|Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and when the participants were able to resume normal activities without stiffness. No stiffness present = 0; stiffness persisted the entire day = 1440 minutes (24 hour times [*] 60 min) was recorded. Change = Week X observation - Baseline observation.|Baseline, Weeks 4, 8, 12, 20, 28 and 36|P1 mITT; N=number of participants with evaluable data; LOCF||minutes (min)||Standard Deviation|Mean
752994|NCT00565409|Secondary|Change From Week 36 in PtGA of Arthritis Pain at Weeks 40, 48, 56, 64, 72, 80, 88|PtGA asked the participant to assess their overall arthritis activity. Participants responded by circling a number ranging from 0 (no disease activity) to 10 (extreme disease activity). Change = Week X observation - Week 36 observation.|Weeks 36, 40, 48, 56, 64, 72, 80, 88|P2 mITT; LOCF||units on a scale||Standard Error|Least Squares Mean
752995|NCT00565409|Secondary|PtGA of Arthritis Pain at Week 36|PtGA asked the participant to assess their overall arthritis activity. Participants responded by circling a number ranging from 0 (no disease activity) to 10 (extreme disease activity).|Week 36|P2 mITT; LOCF||units on a scale||Standard Error|Mean
752996|NCT00565409|Secondary|Change From Baseline in Patient's Global Assessment (PtGA) of Arthritis Pain at Weeks 4, 8, 12, 20, 28 and 36|Participants asked to rate their overall arthritis activity by circling a number ranging from 0 (no disease activity) to 10 (extreme disease activity). Change = Week X observation - Baseline observation.|Baseline, Weeks 4, 8, 12, 20, 28 and 36|P1 mITT; N=number of participants with evaluable data; LOCF||units on a scale||Standard Error|Mean
752997|NCT00565409|Secondary|Change From Week 36 in the PGA Score at Weeks 40, 48, 56, 64, 72, 80 and 88|PGA of Disease Activity was measured on a 0 to 10 Scale, with 0 = no disease activity and 10 = extreme disease activity. Change = Week X observation - Week 36 observation.|Weeks 36, 40, 48, 56, 64, 72, 80 and 88|P2 mITT; LOCF||units on a scale||Standard Error|Least Squares Mean
752998|NCT00565409|Secondary|PGA Score at Week 36|PGA of Disease Activity was measured on a 0 to 10 Scale, with 0 = no disease activity and 10 = extreme disease activity.|Week 36|P2 mITT; LOCF||units on a scale||Standard Error|Mean
752999|NCT00565409|Secondary|Change From Baseline in the Physician Global Assessment (PGA) at Weeks 4, 8, 12, 20, 28 and 36|PGA of Disease Activity was measured on a 0 to 10 Scale, with 0 = no disease activity and 10 = extreme disease activity. Change = Week X observation - Baseline observation.|Baseline, Weeks 4, 8, 12, 20, 28 and 36|P1 mITT; N=number of participants with evaluable data; LOCF||units on a scale||Standard Error|Mean
753000|NCT00565409|Secondary|Change From Week 36 in Painful Joint Count at Weeks 40, 48, 56, 64, 72, 80 and 88|Total of 28 joints were assessed by the investigator using criteria based on pressure and joint manipulation. Total possible scores ranged from -28 to 28. An increase in joint pain count from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression and a decrease represented improvement. Change = Week X observation - Week 36 observation.|Weeks 36 40, 48, 56, 64, 72, 80 and 88|P2 mITT; N=number of participants with evaluable data; LOCF||number of painful joints||Standard Error|Least Squares Mean
753001|NCT00565409|Secondary|Painful Joint Count at Week 36|A total of 28 joints were assessed by the investigator using criteria based on pressure and joint manipulation. Total possible score ranged form 0-28.|Week 36|P2 mITT; LOCF||number of painful joints||Standard Error|Mean
753002|NCT00565409|Secondary|Change From Baseline in the Painful Joint Count at Weeks 4, 8, 12, 20, 28 and 36|A total of 28 joints were assessed by the investigator using criteria based on pressure and joint manipulation. Total possible scores ranged from -28 to 28. An increase in joint pain count from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression and a decrease represented improvement. Change = Week X observation - Baseline observation.|Baseline, Weeks 4, 8, 12, 20, 28 and 36|P1 mITT; N=number of participants with evaluable data; LOCF||number of painful joints||Standard Error|Mean
753003|NCT00565409|Secondary|Change From Week 36 in Prorated Swollen Joint Count at Weeks 40, 48, 56, 64, 72, 80 and 88|ACR, swollen joint count was an assessment of 28 joints. Joints were classified as either swollen or not swollen. If < 20% of swollen joints missing then total swollen joint prorated (multiplied by 28 divided by (/) number of non-missing swollen joints). Total possible score ranged from -28 to 28. An increase in swollen joints from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression and a decrease represented improvement. Change = Week X observation - Week 36 observation.|Week 36, Weeks 40, 48, 56, 64, 72, 80 and 88|P2 mITT; LOCF||number of swollen joints||Standard Error|Least Squares Mean
753004|NCT00565409|Secondary|Prorated Swollen Joint Count at Week 36|ACR, swollen joint count was an assessment of 28 joints. Joints were classified as either swollen or not swollen. If < 20% of swollen joints missing then total swollen joint prorated (multiplied by 28 divided by number of non-missing swollen joints). Total possible score of swollen joints ranged from 0-28.|Week 36|P2 mITT; LOCF||number of swollen joints||Standard Error|Mean
753005|NCT00565409|Secondary|Change From Baseline in Prorated Swollen Joint Count at Weeks 4, 8, 12, 20, 28 and 36|American College of Rheumatology (ACR), swollen joint count were an assessment of 28 joints. Joints are classified as either swollen or not swollen. If < 20% of swollen joints missing then total swollen joint prorated (multiplied by 28 divided by (/) number of non-missing swollen joints). Total possible score ranged from -28 to 28. An increase in swollen joints from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression and a decrease represented improvement. Change = Week X observation – baseline observation.|Baseline, Weeks 4, 8, 12, 20, 28 and 36|P1 mITT; N=number of participants with evaluable data; LOCF||number of swollen joints||Standard Error|Mean
753006|NCT00565409|Secondary|Proportion of Time Participants Had Low Disease Activity DAS28 Week 36 to Week 88|DAS28 calculated from the number of SJC and PJC using the 28 joints, the ESR mm/hour and Patient's General Health VAS. VAS consisted of a line 0 to 100 mm in length; ranged from 0 (very well) to 100mm (extremely bad). Participants placed a mark indicating their health over the previous 2-3 weeks. Higher scores indicated greater affectation due to disease activity. DAS28 < 3.2 units = low disease activity. Cumulative proportion calculated as time-averaged Area Under the Curve (AUC) (AUC divided by number of weeks at that time point), with AUC calculated from Week 36 and Week 88.|Week 36 up to Week 88|P2 mITT; LOCF||proportion of weeks in DAS28 <3.2||Standard Error|Mean
753007|NCT00565409|Secondary|Time to Loss of Low Disease Activity DAS28|DAS28 calculated from the number of SJC and PJC using the 28 joints count, the ESR mm/hour and Patient's General Health VAS. VAS consisted of a line 0 to 100 mm in length; ranged from 0 (very well) to 100mm (extremely bad). Participants placed a mark indicating their health over the previous 2-3 weeks. Higher scores indicated greater affectation due to disease activity. DAS28 ≤ 3.2 units = low disease activity, DAS28 greater than (>)3.2 to 5.1 units = moderate to high disease activity.|Week 36 up to Week 88|P2 mITT;||days||95% Confidence Interval|Median
753008|NCT00565409|Secondary|Time to Loss of Low Disease Activity DAS28 and a Change of ≥ 0.6 Units in the DAS28|DAS28 calculated from the number of SJC and PJC using the 28 joints count, the ESR mm/hour and Patient's General Health VAS. VAS consisted of a line 0 to 100 mm in length; ranged from 0 (very well) to 100mm (extremely bad). Participants placed a mark indicating their health over the previous 2-3 weeks. Higher scores indicated greater affectation due to disease activity. Low disease activity = DAS28 ≤ 3.2 units. DAS28 > 3.2 to 5.1 units = moderate to high disease activity.|Week 36 up to Week 88|P2 mITT;Imputation of failure; observed cases||days||95% Confidence Interval|Median
753009|NCT00565409|Secondary|Change From Week 36 in DAS28 at Weeks 40, 48, 56, 64, 72, 80 and 88|The DAS28 is a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (>5.1=high disease activity; <=3.2=low disease activity; <2.6=remission); a continuous variable which is a composite of 4 variables (the number of tender joints out of 28, the number of swollen joints out of 28 joints, ESR mm/hour and PGA of disease activity measured on a VAS of 100 mm). Change = Week X observation - Week 36 observation.|Weeks 36, 40, 48, 56, 64, 72, 80 and 88|P2 mITT; LOCF; N=number of participants with evaluable data||units on a scale||Standard Error|Least Squares Mean
753010|NCT00565409|Secondary|Change From Baseline in DAS28 at Weeks 4, 8, 12, 20, 28 and 36|The DAS28 is a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (>5.1=high disease activity; <=3.2=low disease activity; <2.6=remission); a continuous variable which is a composite of 4 variables (the number of tender joints out of 28, the number of swollen joints out of 28 joints, erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient’s global assessment (PGA) of disease activity measured on a visual analogue scale (VAS) of 100 mm). Change equals (=) Week X observation minus (-) Baseline observation.|Baseline, Weeks 4, 8, 12, 20, 28 and 36|P1 mITT; Last observation carried forward (LOCF); N=Number of participants with evaluable data||units on a scale||Standard Error|Mean
753011|NCT00565409|Secondary|Percentage of Participants Achieving DAS28 Low Disease Activity or Remission|DAS28 calculated from the number of SJC and PJC using the 28 joints count, the ESR mm/hour and and Patient's General Health VAS. VAS consisted of a line 0 to 100 mm in length; ranged from 0 (very well) to 100mm (extremely bad). Participants placed a mark indicating their health over the previous 2-3 weeks. Higher scores indicated greater affectation due to disease activity. DAS28 ≤ 3.2 units = low disease activity, DAS28 < 2.6 units = remission.|Weeks 36, 40, 48, 56, 64, 72, 80 and 88|Period 2 (P2) mITT||Percentage of participants|||Number
753012|NCT00565409|Secondary|Percentage of Participants Achieving DAS28 Low Disease Activity or Remission at Baseline, Weeks 4, 8, 12, 20, 28 and 36|DAS28 calculated from the number of SJC and PJC using the 28 joints count, the ESR mm/hour and and Patient's General Health VAS. VAS consisted of a line 0 to 100 mm in length; ranged from 0 (very well) to 100mm (extremely bad). Participants placed a mark indicating their health over the previous 2-3 weeks. Higher scores indicated greater affectation due to disease activity. DAS28 ≤ 3.2 units = low disease activity, DAS28 < 2.6 units = remission.|Baseline, Weeks 4, 8, 12, 20, 28, 36|Period 1 Modified Intent to Treat population (P1 mITT): all participants who took at least 1 dose of open-label test article; N=number of participants with evaluable data; Last observation carried forward (LOCF)||percentage of participants|||Number
753013|NCT00565409|Primary|Percentage of Participants Achieving 28 Joint Disease Activity Score (DAS28) Less Than or Equal to (≤) 3.2 at Week 88|DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joint count (less than [<]20 percent [%] missing SJC or PJC was prorated), erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and Patient's General Health Visual Analog Scale (VAS). VAS is a line 0-100 millimeters (mm) in length; ranged from 0 (very well)-100mm (extremely bad). Participants placed a mark indicating their health over the previous 2-3 weeks. Higher scores indicated greater affectation due to disease activity. DAS28 ≤ 3.2 units equals (=) low disease activity.|Week 88|Modified Intent to Treat population (mITT): all participants who took at least 1 dose of double-blind test article and had at least 1 post-randomization DAS28 evaluation||percentage of participants|||Number
753014|NCT00565448|Secondary|Overall Survival (OS) Rate|OS rate is the percentage of participants who survived 3 years after completion of consolidation treatment period. The Kaplan-Meier method was used to estimate OS rate.|3 years after the end of the consolidation treatment period (up to 40 months from randomization)|ITT population: all randomized participants.||percentage of participants||95% Confidence Interval|Number
753015|NCT00565448|Secondary|Overall Response (OR)|OR is classified as CR, partial response (PR), stable disease (SD), progressive disease (PD) or Unknown on completion of both induction and radiation treatment and assessed according to the Modified RECIST from the NCI. CR is defined as the disappearance of all target lesions (TLs) and non-TLs. PR is defined as ≥30% decrease in the sum of the longest diameters (LD) of TLs, taking as reference the disease measurement done at study entry. PD is defined as ≥20% increase in the sum of the LD of TLs, taking as a reference the smallest disease measurement recorded at study entry or the appearance of ≥1 new lesions or unequivocal progression of non-TLs. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|after the completion of the consolidation treatment (up to 18 weeks)|ITT population: all randomized participants.||participants|||Number
753034|NCT00565643|Secondary|Post-operative Hemoglobin|Hemoglobin level following randomization delivery - used to determine if there was a difference in blood loss between the two groups|1 to 5 years|||% of blood that is red blood cells||Standard Deviation|Mean
753016|NCT00565448|Secondary|Docetaxel Area Under the Plasma Concentration-time Curve (AUC) in the Docetaxel/Cisplatin/5-FU Group|AUC estimated by Bayesian method using concentration–time data for each participant and the previously defined adult population model as prior information (with validity of the estimation verified).|Three plasma samples: one just before then 45 minutes and 5hour after the end of cycle 1 infusion|Participants who were randomized to docetaxel/cisplatin/5-FU and had evaluable docetaxel pharmacokinetic (PK) sample.||µg*h/mL||Standard Deviation|Mean
753017|NCT00565448|Primary|Number of Participants With Complete Response (CR)|CR assessed by independent reviewers, according to the Modified Response Evaluation Criteria in Solid Tumors (RECIST) from the National Cancer Institute (NCI). Disease response evaluated after the completion of the induction treatment and prior to the radiation treatment. CR defined as the complete disappearance of the target and non-target lesion(s) identified at baseline after radiological evaluation by Magnetic Resonance Imaging (MRI) only.|after the completion of the induction treatment (up to 9 weeks)|ITT population: all randomized participants.||participants|||Number
753018|NCT00565461|Primary|Seroconversion After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch.|"The primary endpoint of this trial was to compare the immunogenicity (i.e., GMTs, GMFRs and seroconversion rates (SCR) for LT IgG and IgA) of subject self-administered [second] vaccination with clinician-administered [second] vaccination, using the deltoid/thigh (Vaccination 1/Vaccination 2) treatment regimen.
seroconversion (SC): two-fold or greater rise in titer relative to Day 0 for LT IgG and a four-fold or greater rise in titer relative to Day 0 for LT IgA"|Day 14, Day 21, Day 28, Day 35, Day 194|intent to treat population = primary analysis population; defined as all study subjects who were consented, randomized, and had a baseline serology||percentage of study participants||95% Confidence Interval|Number
753019|NCT00565461|Primary|GMFR After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch.|"The primary endpoint of this trial was to compare the immunogenicity (i.e., GMTs, GMFRs and seroconversion rates for LT IgG and IgA) of subject self-administered [second] vaccination with clinician-administered [second] vaccination, using the deltoid/thigh (Vaccination 1/Vaccination 2) treatment regimen.
GMFR: geometric mean fold ratio GMFRs relative to the baseline titer were determined for LT IgG and LT IgA at each post-baseline time point. All GMFRs were based on log10-transformed data."|Day 14, Day 21, Day 28, Day 35, Day 194|intent to treat population = primary analysis population; defined as all study subjects who were consented, randomized, and had a baseline serology||geometric mean fold ratio||95% Confidence Interval|Number
753020|NCT00565461|Secondary|Safety and Evaluation of Immunogenicity for Self-administration In-clinic Compared to Self-administration Away From the Clinic.||6 months||||||
753021|NCT00565461|Secondary|Evaluation of Immunogenicity for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine.||6 months||||||
753022|NCT00565461|Secondary|Safety of Self-administered LT Vaccine Patch and Comparison to the Clinician-administered LT Vaccine Patch||6 months||||||
753023|NCT00565461|Primary|GMTs After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch.|"The primary endpoint of this trial was to compare the immunogenicity (i.e., GMTs, GMFRs and seroconversion rates for LT IgG and IgA) of subject self-administered [second] vaccination with clinician-administered [second] vaccination, using the deltoid/thigh (Vaccination 1/Vaccination 2) treatment regimen.
GMT: geometric mean titer"|Day 0, Day 14, Day 21, Day 28, Day 35, Day 194|intent to treat population = primary analysis population; defined as all study subjects who were consented, randomized, and had a baseline serology||geometric mean titers||95% Confidence Interval|Geometric Mean
753024|NCT00565604|Secondary|Secondary Safety Objective|Safety: Incidence rate of device-related minor adverse events.|6 Months|The number of subjects that were enrolled in the trial.||Participants|||Number
753025|NCT00565604|Secondary|Secondary Effectiveness Objective|Effectiveness: The reduction in patient symptoms and the satisfaction of the patient. Patient symptom assessment - CEAP Class, best=0 (no visible or palpable signs of venous disease) & worst=6 (Skin changes in conjunction with active ulceration), VDS, best=0 (asymptomatic) & worst=3 (unable to carry out usual activities even with compression and/or limb elevation) and VCSS, best=0 (absent) & worst=3 (severe). Patient satisfaction - modified Odom’s criteria, best=excellent (I am very satisfied with the results of my laser treatment) & worst=poor (I am not satisfied with the results).|6 Months|The number of patients still participating in the study at 6-months.||Participants|||Number
753026|NCT00565604|Primary|Primary Safety Objective|Safety: Evaluation of occurrence of major device-related adverse events through 6 weeks and the total at 6 months.|6 Months|The number of patients that were enrolled in the study.||Participants|||Number
753027|NCT00565604|Primary|Primary Effectiveness Objective|The primary objective is to demonstrate the clinical effectiveness (as determined by the absence of flow within the treated incompetent perforated vein [IPV])) of endovenous laser ablation. The number of treated IPVs that are closed at 6 weeks and remain closed at 6 months.|6 Months|The number of patients still participating in the study at 6-months.||Treated IPVs|Participants||Number
753028|NCT00565617|Primary|HDRS-24 Items|"Hamilton Depression Rating Scale (HDRS) is a standard, validated depression rating scale.
It is a 24 item scale, but the primary score is based on the first 17 answers for a total score for depression.
0-7=Normal 8 - 13 = Mild Depression 14-18 = Moderate Depression 19 - 22 = Severe Depression > 23 = Very Severe Depression"|7 months from baseline|||units on a scale||Standard Deviation|Mean
753029|NCT00565643|Secondary|Operative Times at Subsequent Delivery|Amount of time spent at the time of the subsequent delivery|3 to 5 years|||minutes||Full Range|Median
753030|NCT00565643|Secondary|Post-operative Maximum Temperature Following Randomization|Maximum temperature of patient, >24 hours following randomization delivery|1 to 5 years|||degrees Fahrenheit||Standard Deviation|Mean
753031|NCT00565643|Secondary|Post-Operative Complications|Percentage of patients experiencing any of the predefined post-operative complications following randomization|1 to 5 years|||% of patients experiencing complication|||Number
753032|NCT00565643|Secondary|Post-operative White Blood Cell Count|Post-operative White blood cell count following randomization delivery - used to determine if there was difference in immune response or infection between the groups|1 to 5 years|||cells/mm^3||Standard Deviation|Mean
753035|NCT00565643|Primary|Incidence of Adhesions|The Percentage of participants with one or more adhesions, regardless of the extent or severity|3 to 5 years|||percentage of patients with adhesions|||Number
753036|NCT00565721|Secondary|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors. (Correlation Between SUVR_55_blood and αvβ5 Optical Density)|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.|Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.|This Outcome Measure was assessed among the Renal Cell Carcinoma (RCC) subjects, 12 of the 22 Subjects had Renal Cell Carcinoma (RCC).||Correlation coefficient||95% Confidence Interval|Number
753037|NCT00565721|Secondary|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors. (Correlation Between SUVw_55 and αvβ5 Optical Density)|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.|Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.|This Outcome Measure was assessed among the Renal Cell Carcinoma (RCC) subjects, 12 of the 22 Subjects had Renal Cell Carcinoma (RCC).||Correlation coefficient||95% Confidence Interval|Number
753038|NCT00565721|Secondary|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors. (Correlation Between VT_inp-Logan and αvβ5 Optical Density)|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.|Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.|This Outcome Measure was assessed among the Renal Cell Carcinoma (RCC) subjects, 12 of the 22 Subjects had Renal Cell Carcinoma (RCC).||Correlation coefficient||95% Confidence Interval|Number
753039|NCT00565721|Secondary|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors. (Correlation Between Ki_inp-Patlak and αvβ5 Optical Density)|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.|Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.|This Outcome Measure was assessed among the Renal Cell Carcinoma (RCC) subjects, 12 of the 22 Subjects had Renal Cell Carcinoma (RCC).||Correlation coefficient||95% Confidence Interval|Number
753040|NCT00565721|Secondary|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors. (Correlation Between SUVR_55_blood and αvβ5 Optical Density)|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Full Analysis Set (FAS) subjects. Correlation strength was defined descriptively.|Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.|This Outcome Measure was assessed among the Full Analysis Set (FAS), 2 of the 22 Subjects did not have any αvβ5 integrin results.||Correlation coefficient||95% Confidence Interval|Number
753041|NCT00565721|Secondary|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors. (Correlation Between SUVw_55 and αvβ5 Optical Density)|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Full Analysis Set (FAS) subjects. Correlation strength was defined descriptively.|Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.|This Outcome Measure was assessed among the Full Analysis Set (FAS), 2 of the 22 Subjects did not have any αvβ5 integrin results.||Correlation coefficient||95% Confidence Interval|Number
753042|NCT00565721|Primary|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ3 Integrin Expression in Tumors. (Correlation Between SUVR_55_blood and αvβ3 Optical Density)|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.|Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.|This Outcome Measure was assessed among the Renal Cell Carcinoma (RCC) subjects, 12 of the 22 Subjects had Renal Cell Carcinoma (RCC).||Correlation coefficient||95% Confidence Interval|Number
753043|NCT00565721|Primary|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ3 Integrin Expression in Tumors. (Correlation Between SUVw_55 and αvβ3 Optical Density)|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.|Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.|This Outcome Measure was assessed among the Renal Cell Carcinoma (RCC) subjects, 12 of the 22 Subjects had Renal Cell Carcinoma (RCC).||Correlation coefficient||95% Confidence Interval|Number
753044|NCT00565721|Primary|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ3 Integrin Expression in Tumors. (Correlation Between VT_inp-Logan and αvβ3 Optical Density)|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.|Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.|This Outcome Measure was assessed among the Renal Cell Carcinoma (RCC) subjects, 12 of the 22 Subjects had Renal Cell Carcinoma (RCC).||Correlation coefficient||95% Confidence Interval|Number
753045|NCT00565721|Primary|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ3 Integrin Expression in Tumors. (Correlation Between Ki_inp-Patlak and αvβ3 Optical Density)|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.|Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.|This Outcome Measure was assessed among the Renal Cell Carcinoma (RCC) subjects, 12 of the 22 Subjects had Renal Cell Carcinoma (RCC).||Correlation coefficient||95% Confidence Interval|Number
755306|NCT00593606|Primary|Change in Potassium|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||mmol/l||Standard Deviation|Mean
753046|NCT00565721|Primary|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ3 (Beta-3 Integrin) Integrin Expression in Tumors. (Correlation Between SUVR_55_blood and αvβ3 Optical Density)|"Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.
Twelve (12) of the 22 subjects had renal cell carcinoma (RCC) the remaining subjects did not have RCC.
SUVR_55_blood is the standard uptake value ratio (tumor-to-blood) at 55 minutes post-injection."|Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.|This Outcome Measure was assessed among the Full Analysis Set (FAS), 3 of the 22 Subjects did not have any αvβ3 integrin results.||Correlation coefficient||95% Confidence Interval|Number
753047|NCT00565721|Primary|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ3 (Beta-3 Integrin) Integrin Expression in Tumors. (Correlation Between SUVw_55 and αvβ3 Optical Density)|"Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Full Analysis Set (FAS) subjects. Correlation strength was defined descriptively.
SUVw_55 is the standard uptake value at 55 minutes post-injection, normalized to weight."|Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.|This Outcome Measure was assessed among the Full Analysis Set (FAS), 3 of the 22 Subjects did not have any αvβ3 integrin results.||Correlation coefficient||95% Confidence Interval|Number
753048|NCT00565721|Secondary|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors. (Correlation Between VT_inp-Logan and αvβ5 Optical Density)|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Full Analysis Set (FAS) subjects. Correlation strength was defined descriptively.|Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.|This Outcome Measure was assessed among the Full Analysis Set (FAS), 2 of the 22 Subjects did not have any αvβ5 integrin results.||Correlation coefficient||95% Confidence Interval|Number
753049|NCT00565721|Secondary|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors. (Correlation Between Ki_inp-Patlak αvβ5 Optical Density)|"Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Full Analysis Set (FAS) subjects. Correlation strength was defined descriptively. 0.60 to 0.44 equals a moderately positive correlation and 0.33 to 0.37 equals a weak positive correlation.
Two (2) of the 22 subjects did not have any αvβ5 integrin results."|Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.|This Outcome Measure was assessed among the Full Analysis Set (FAS), 2 of the 22 Subjects did not have any αvβ5 integrin results.||Correlation coefficient||95% Confidence Interval|Number
753050|NCT00565721|Primary|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ3 Integrin Expression in Tumors. (Correlation Between VT_inp-Logan and αvβ3 Optical Density)|"Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Full Analysis Set (FAS) subjects. Correlation strength was defined descriptively.
The Logan plot is the counterpart of the Patlak plot for reversible radiotracers."|Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.|This Outcome Measure was assessed among the Full Analysis Set (FAS), 3 of the 22 Subjects did not have any αvβ3 integrin results.||Correlation coefficient||95% Confidence Interval|Number
753051|NCT00565721|Primary|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ3 (Beta-3 Integrin) Integrin Expression in Tumors. (Correlation Between Ki_inp-Patlak and αvβ3 Optical Density)|"Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Full Analysis Set (FAS) subjects. Correlation strength was defined descriptively. 0.22 and 0.24 equals a weak positive correlation and 0.16 and 0.18 equals a negligible correlation.
Three (3) of the 22 subjects did not have any αvβ3 integrin results. Ki-inp-Patlak is a graphical analysis technique based on the compartment model that uses linear regression to identify and analyze pharmacokinetics of tracers involving irreversible uptake."|Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.|This Outcome Measure was assessed among the Full Analysis Set (FAS), 3 of the 22 Subjects did not have any αvβ3 integrin results.||Correlation coefficient||95% Confidence Interval|Number
753052|NCT00565747|Secondary|Live Birth|Subject having at least one live birth. Including a foetus which breathes or shows any other evidence of life after expulsion/extraction from its mother. The definition is independent of the duration of the pregnancy (ICMART/WHO criteria).|Until 7 days after birth|PP-population||percentage of transfer patients|||Number
753053|NCT00565747|Secondary|Number of Top Quality Embryos (TQE´s)|Number of 4-5 cell embryo at 44 hours,at least 7 cell embryo at 68 hours, maximum 20% fragmentation, equally large blastomeres (less than 25% difference in size),No signs of multinucleation. Calculated in percentage of number of 2 pronuclei (2PN) oocytes.|3 days from oocyte pick-up|PP-population||percentage of 2PN's|||Number
753054|NCT00565747|Primary|Ongoing Implantation Rate Week 7|Defined as number of gestational sacs with fetal heart beat, shown by ultrasound in gestational week 7 in percentage of number of embryo transferred.|Approximately 5 weeks from oocyte pick-up (corresponding to 7 weeks from ovulation)|PP-population||percentage of transferred embryos|Participants||Number
753055|NCT00565812|Other Pre-specified|Change From Baseline in Heart Rate at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96||Baseline, Week 2, 4, 12, 24, 36, 48, 60, 72, 84, 96|The safety analysis set included all participants in the FAS who received at least 1 dose of the study medication. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.||beats per minute (bpm)||Standard Deviation|Mean
753064|NCT00565812|Secondary|Patient Global Impression of Change Score|Patient global impression of change was a participant-rated instrument that measured change in participant’s overall status on a 7-point scale ranging from: 1 =very much improved, 2 =much improved, 3 =minimally improved, 4 =no change, 5 =minimally worse, 6 =much worse and 7 =very much worse. Higher scores indicating worse condition.|Month 24|FAS included all participants randomized to the study. Here, 'N' signifies participants evaluable for this outcome measure.||units on a scale||Standard Deviation|Mean
753056|NCT00565812|Other Pre-specified|Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96|BP was measured by sphygmomanometer while participant was in supine position. Conditions were kept constant from visit to visit including observer, participant’s same arm, cuff size, supine position, location, temperature, noise level. The same size BP cuff which was properly sized and calibrated, was used to measure BP each time.|Baseline, Week 2, 4, 12, 24, 36, 48, 60, 72, 84, 96|The safety analysis set included all participants in the FAS who received at least 1 dose of the study medication. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.||mmHg||Standard Deviation|Mean
753057|NCT00565812|Other Pre-specified|Change From Baseline in Systolic Blood Pressure (SBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96|Blood pressure (BP) was measured by sphygmomanometer while participant was in supine position. Conditions were kept constant from visit to visit including observer, participant’s same arm, cuff size, supine position, location, temperature, noise level. The same size BP cuff which was properly sized and calibrated, was used to measure BP each time.|Baseline, Week 2, 4, 12, 24, 36, 48, 60, 72, 84, 96|The safety analysis set included all participants in the FAS who received at least 1 dose of the study medication. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.||millimeters of mercury (mmHg)||Standard Deviation|Mean
753058|NCT00565812|Other Pre-specified|Number of Participants With Laboratory Test Abnormalities|Criteria for laboratory abnormalities: Hemoglobin (Hgb), hematocrit (hct), red blood cell(RBC) count: less than(<)0.8*lower limit of normal(LLN), platelet: <0.5*LLN or greater than (>)1.75*upper limit of normal (ULN), white blood cell (WBC): <0.6*LLN or >1.5*ULN, lymphocyte, neutrophil:<0.8*LLN or >1.2*ULN, basophil, eosinophil, monocyte:>1.2*ULN; total bilirubin >1.5*ULN, aspartate aminotransferase, alanine aminotransferase, gammaglutamyl transferase, alkaline phosphatase:> 3.0*ULN, total protein, albumin: <0.8*LLN or >1.2*ULN; blood urea nitrogen, creatinine:>1.3*ULN, uric acid >1.2*ULN; sodium <0.95*LLN or >1.05*ULN, potassium, chloride, calcium, magnesium, bicarbonate: <0.9*LLN or >1.1*ULN, phosphate <0.8*LLN or >1.2*ULN; glucose <0.6*LLN or >1.5*ULN, lipase >1.5*ULN; urine (specific gravity <1.003 or >1.030, pH <4.5 or >8, glucose, ketones, protein, blood/Hgb greater than or equal to [>=]1); pancreatic amylase >1.5*ULN.|Baseline up to Week 111|The safety analysis set included all participants in the FAS who received at least 1 dose of the randomized study medication. Here, 'N' signifies participants evaluable for this outcome measure.||participants|||Number
753059|NCT00565812|Other Pre-specified|Number of Participants With Electrocardiogram (ECG) Abnormalities|Atrial (enlargement, fibrillation, premature beat), axis deviation, atrioventricular (accelerated conduction, first/second degree block), left anterior and posterior hemiblock, left atrial hypertrophy, left and right (complete/incomplete bundle branch block, ventricular hypertrophy), QRS (high/low voltage, nonspecific, prolongation greater than [>]140 milliseconds [msec]), junctional/paced rhythm, intraventricular conduction delay (>120 msec), early repolarization, ventricular premature contraction and beat, prolonged QTC, sinus (arrhythmia, bradycardia/tachycardia), supraventricular extra systole and premature beat, short PR syndrome. Abnormal Q-wave (>=30 msec), P-wave left/right atrial abnormality, T-wave flattened/inverted abnormality, U-wave abnormality, ST-T indeterminate abnormality, ST-T nonspecific changes, ST-T changes compatible with ischemia and pericarditis. ECG findings were judged by investigators for qualitative evaluation of abnormalities.|Baseline, Month 3, 6, 12, 18, 24|The safety analysis set included all participants in the FAS who received at least 1 dose of the randomized study medication. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.||participants|||Number
753060|NCT00565812|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 7-10 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. Adverse events included both serious and non-serious adverse events.|Baseline up to 7-10 days after last dose of study drug (Week 111)|The safety analysis set included all participants in the FAS who received at least 1 dose of the randomized study medication.||participants|||Number
753061|NCT00565812|Secondary|Number of Participants Applicable for Virtual Joint Replacement|A virtual joint replacement candidate was defined as a participant whose last two WOMAC pain subscale scores (overall score range of 0 [minimum] to 20 [maximum], higher scores indicating more pain) were at least 8, last two WOMAC physical function subscale scores (overall score range of 0 [minimum] to 68 [maximum], higher scores indicating worse physical function) were at least 28 and was a joint space narrowing progressor (a participant with a decrease in JSW that was greater in magnitude than the smallest detectable difference =0.199 mm).|Month 24|FAS included all participants randomized to the study. Here, 'N' signifies participants evaluable for this outcome measure.||participants|||Number
753062|NCT00565812|Secondary|Number of Participants With Joint Space Narrowing Progression|JSN progressor was defined as a participant with a decrease in joint space width that was greater in magnitude than the smallest detectable difference (0.199 mm).|Month 24|FAS included all participants randomized to the study. Here, 'N' signifies participants evaluable for this outcome measure.||participants|||Number
753063|NCT00565812|Secondary|Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index|The OMERACT-OARSI responder index was used to determine whether participants may be considered responders to treatment. An OMERACT-OARSI responder was a participant who had a better response on the WOMAC pain subscale score, a better response on the WOMAC physical function subscale score or improvement on at least two of the three domains: WOMAC pain subscale score (overall score range of 0 [minimum] to 20 [maximum], higher scores indicating more pain), WOMAC physical function subscale score (overall score range of 0 [minimum] to 68 [maximum], higher scores indicating worse physical function) and patient global assessment of arthritic condition score (overall score range of 1 [minimum] to 5 [maximum], higher scores indicating worse condition). Number of participants who were OMERACT-OARSI responder were reported in this measure.|Month 24|FAS included all participants randomized to the study. Here, 'N' signifies participants evaluable for this outcome measure.||participants|||Number
755307|NCT00593606|Primary|Change in Inorganic Phosphate|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||mg/dl||Standard Deviation|Mean
753065|NCT00565812|Secondary|Number of Participants With Decrease in Total Analgesic Medication Use|Decrease in total analgesic medication use for OA in the study knee was a comparison back to baseline of a decreased and irregular use of standard background and/or rescue medication for more than 28 days as measured at the Month 12 and 24 visits. Only medications for OA knee pain were considered.|Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.||participants|||Number
753066|NCT00565812|Secondary|Number of Participants With Increase in Total Analgesic Medication Use|Increase in total analgesic medication use for OA in the study knee was a comparison back to baseline of an increased and sustained use of standard background and/or rescue medication for more than 28 days as measured at the Month 12 and 24 visits. Only medications for OA knee pain were considered.|Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.||participants|||Number
753067|NCT00565812|Secondary|EuroQoL-5D Visual Analog Scale Score|The EQ-5D VAS score was a participant rated questionnaire to assess health-related quality of life in terms of a single index value. It was a visual analogue scale that ranged from 0 (minimum) to 100 (maximum), with higher scores indicating a better health condition.|Baseline, Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.||units on a scale||Standard Deviation|Mean
753068|NCT00565812|Secondary|Number of Participants With EuroQoL-5D Anxiety and Depression Domain Score|EQ-5D: participant rated questionnaire to assess health-related quality of life. Health state profile component assessed level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. EQ-5D anxiety and depression domain score scale ranged from 1 (minimum) to 3 (maximum), where 1 =better health (not anxious, depressed), 2 =moderate health (moderately anxious, depressed) and 3 =worst health (extremely anxious, depressed). Higher scores indicating worse health condition. Participants with EQ-5D anxiety and depression domain score were reported in this measure.|Baseline, Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.||participants|||Number
753069|NCT00565812|Secondary|Number of Participants With EuroQo-5D Pain and Discomfort Domain Score|EQ-5D: participant rated questionnaire to assess health-related quality of life. Health state profile component assessed level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. EQ-5D pain and discomfort domain score scale ranged from 1 (minimum) to 3 (maximum), where 1 =better health (no pain and discomfort), 2 =moderate health (moderate pain and discomfort) and 3 =worst health state (extreme pain and discomfort). Higher scores indicated worse health condition. Participants with EQ-5D pain and discomfort domain score were reported in this measure.|Baseline, Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.||participants|||Number
753070|NCT00565812|Secondary|Number of Participants With EuroQoL-5D Usual Activity Domain Score|EQ-5D: participant rated questionnaire to assess health-related quality of life. Health state profile component assessed level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. EQ-5D usual activity domain score scale ranged from 1 (minimum) to 3 (maximum), where 1 =better health (no problems), 2 =moderate health (some problems) and 3 =worst health state (unable to perform usual activities). Higher scores indicating worse health condition. Participants with EQ-5D usual activity domain score were reported in this measure.|Baseline, Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.||participants|||Number
753071|NCT00565812|Secondary|Number of Participants With EuroQoL-5D Self-Care Domain Score|EQ-5D: participant rated questionnaire to assess health-related quality of life. Health state profile component assessed level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. EQ-5D self-care domain score scale ranged from 1 (minimum) to 3 (maximum), where 1 =better health (no problems with self-care), 2 =moderate health (some problems) and 3 =worst health (unable to wash or dress). Higher scores indicating worse health condition. Participants with EQ-5D self-care domain score were reported in this measure.|Baseline, Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.||participants|||Number
753072|NCT00565812|Secondary|Number of Participants With EuroQoL-5D (EQ-5D) Mobility Domain Score|EQ-5D: participant rated questionnaire to assess health-related quality of life. Health state profile component assessed level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. EQ-5D mobility domain score scale ranged from 1 (minimum) to 3 (maximum), where 1 =better health (no problem), 2 =moderate health (some problems) and 3 =worst health (confined to bed). Higher scores indicating worse health condition. Participants with EQ-5D mobility domain score were reported in this measure.|Baseline, Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.||participants|||Number
753073|NCT00565812|Secondary|Change From Baseline in Short Form-36 Mental Health Component Score at Month 12 and 24|The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 11.11 (minimum) to 61.67 (maximum), with higher scores indicating better mental health.|Baseline, Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.||units on a scale||Standard Deviation|Mean
753262|NCT00567255|Secondary|Body Weight- Proportion of Subjects With ≥10% Decrease From Baseline to Week 28||Baseline, 28 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||percentage of participants||95% Confidence Interval|Number
753074|NCT00565812|Secondary|Change From Baseline in Short Form-36 Physical Health Component Score at Month 12 and 24|The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 22.88 (minimum) to 58.69 (maximum), with higher scores indicating better physical health.|Baseline, Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.||units on a scale||Standard Deviation|Mean
753075|NCT00565812|Secondary|Change From Baseline in Short Form-36 Mental Health Domain Score at Month 12 and 24|The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 8.02 (minimum) to 63.43 (maximum), with higher scores indicating better mental health.|Baseline, Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.||units on a scale||Standard Deviation|Mean
753076|NCT00565812|Secondary|Change From Baseline in Short Form-36 Role-Emotional Domain Score at Month 12 and 24|The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 10.25 (minimum) to 55.68 (maximum), with higher scores indicating better role-emotional.|Baseline, Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.||units on a scale||Standard Deviation|Mean
753077|NCT00565812|Secondary|Change From Baseline in Short Form-36 Social Functioning Domain Score at Month 12 and 24|The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 13.38 (minimum) to 56.40 (maximum), with higher scores indicating better social functioning.|Baseline, Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.||units on a scale||Standard Deviation|Mean
753078|NCT00565812|Secondary|Change From Baseline in Short Form-36 Vitality Domain Score at Month 12 and 24|The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 22.02 (minimum) to 69.92 (maximum), with higher scores indicating better vitality.|Baseline, Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.||units on a scale||Standard Deviation|Mean
753079|NCT00565812|Secondary|Change From Baseline in Short Form-36 General Health Domain Score at Month 12 and 24|The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 16.75 (minimum) to 63.72 (maximum), with higher scores indicating better general health.|Baseline, Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.||units on a scale||Standard Deviation|Mean
753080|NCT00565812|Secondary|Change From Baseline in Short Form-36 Bodily Pain Domain Score at Month 12 and 24|The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 19.23 (minimum) to 60.88 (maximum), with higher scores indicating lower bodily pain.|Baseline, Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.||units on a scale||Standard Deviation|Mean
753081|NCT00565812|Secondary|Change From Baseline in Short Form-36 Role - Physical Domain Score at Month 12 and 24|The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 18.45 (minimum) to 56.62 (maximum), with higher scores indicating better role-physical.|Baseline, Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.||units on a scale||Standard Deviation|Mean
753082|NCT00565812|Secondary|Change From Baseline in Short Form-36 (SF-36) Physical Functioning Domain Score at Month 12 and 24|The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 16.18 (minimum) to 57.11 (maximum), with higher scores indicating better physical functioning.|Baseline, Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.||units on a scale||Standard Deviation|Mean
753083|NCT00565812|Secondary|Change From Baseline in Knee Injury and Osteoarthritis Outcome Score – Physical Function Short Form (KOOS-PS) Score at Month 3, 6, 12, 18 and 24|The KOOS-PS was used to rate participant’s opinions about the difficulties they experienced with activity due to problems with their knee. It was a 7-item scale, each item scored from 0 (minimum) to 4 (maximum), where 4 indicated worst health condition. Total score was calculated by adding the responses to 7 items and rescaled to a 0 (minimum) to 100 (maximum) scale, where higher scores indicating worse health condition.|Baseline, Month 3, 6, 12, 18, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.||units on a scale||Standard Deviation|Mean
753084|NCT00565812|Secondary|Change From Baseline in Osteoarthritis Research Society International (OARSI) Knee Function Survey Score at Month 3, 6, 12, 18 and 24|The OARSI knee function survey was an 11-item scale with each item scored 0 (minimum) to 4 (maximum), where 4 indicated worst health condition. The total score was the sum of the 11 items and ranged from 0 (minimum) to 44 (maximum), where higher scores indicating worse health condition.|Baseline, Month 3, 6, 12, 18, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.||units on a scale||Standard Deviation|Mean
753085|NCT00565812|Secondary|Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Intermittent Pain Subscale Score at Month 3, 6, 12, 18 and 24|The OA pain assessment tool-knee joint intermittent pain subscale score a 6 item scale, with each item scored from 0 (minimum) to 4 (maximum), where 4 indicated worst health condition. Overall subscale score was calculated by adding the 6 items and rescaled to a 0 (minimum) to 100 (maximum) scale, where higher scores indicating worse intermittent pain.|Baseline, Month 3, 6, 12, 18, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.||units on a scale||Standard Deviation|Mean
753086|NCT00565812|Secondary|Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Constant Pain Subscale Score at Month 3, 6, 12, 18 and 24|The OA pain assessment tool-knee joint constant pain subscale was a 5 item scale, with each item scored from 0 (minimum) to 4 (maximum), where 4 indicated worst health condition. Overall subscale score was calculated by adding the 5 items and rescaled to a 0 (minimum) to 100 (maximum) scale, where higher scores indicating worse constant pain.|Baseline, Month 3, 6, 12, 18, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.||units on a scale||Standard Deviation|Mean
753087|NCT00565812|Secondary|Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Total Score at Month 3, 6, 12, 18 and 24|The OA pain and assessment tool-knee joint is also known as the intermittent and constant osteoarthritis pain (ICOAP) scale. The OA pain assessment tool-knee joint was an 11-item scale, with each item scored from 0 (minimum) to 4 (maximum), where 4 indicated worst health condition. The total score was calculated by adding the 11 items and rescaled to a 0 (minimum) to 100 (maximum) scale, where higher scores indicating worse health.|Baseline, Month 3, 6, 12, 18, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluated for this outcome measure at given time points for each group.||units on a scale||Standard Deviation|Mean
753088|NCT00565812|Secondary|Change From Baseline in Pain After a 50-foot Walk Using Pain Visual Analog Scale Score at Month 3, 6, 12, 18 and 24|The pain VAS following a 50 foot walk was a single-item, self-administered instrument. Participants were asked to assess the pain due to OA in their study knee after a 50-foot walk. Participants responded on a VAS scale ranging from 0 (no pain) to 100 (severe pain). Higher scores indicating more pain.|Baseline, Month 3, 6, 12, 18, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.||units on a scale||Standard Deviation|Mean
753089|NCT00565812|Secondary|Change From Baseline in Physician’s Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24|Physician assessed the overall impact of arthritis on the participant’s daily life. Participant’s condition was rated by the physician using the scale ranging from 1 (minimum) to 5 (maximum), where 1= very good, 2= good, 3= fair, 4= poor and 5= very poor. Higher scores indicating worse condition.|Baseline, Month 3, 6, 12, 18, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.||units on a scale||Standard Deviation|Mean
755308|NCT00593606|Primary|Change in Glucose|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||mg/dl||Standard Deviation|Mean
753090|NCT00565812|Secondary|Change From Baseline in Patient Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using the scale ranging from 1 (minimum) to 5 (maximum), where 1 =very good, 2 =good, 3 =fair, 4 =poor and 5 =very poor. Higher scores indicating worse condition."|Baseline, Month 3, 6, 12, 18, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.||units on a scale||Standard Deviation|Mean
753091|NCT00565812|Secondary|Change From Baseline in Patient Assessment of Arthritic Pain Visual Analog Scale (VAS) Score at Month 3, 6, 12, 18 and 24|Pain VAS was a self-administered instrument, a 100 millimeter (mm) line marked by participant. Intensity of pain range (over past week): 0 (mm) =no pain to 100 (mm) =worst possible pain. Higher score indicating severe pain.|Baseline, Month 3, 6, 12, 18, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.||mm||Standard Deviation|Mean
753092|NCT00565812|Secondary|Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Physical Function Subscale Score at Month 3, 6, 12, 18 and 24|The WOMAC physical function subscale referred to the participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale was comprised of 17 questions regarding the degree of difficulty experienced due to OA in the study knee. The WOMAC physical function subscale score for each question ranged from 0 (minimum) to 4 (maximum), higher scores signified worse physical function. An overall score range of 0 (minimum) to 68 (maximum), with higher scores indicating worse physical function.|Baseline, Month 3, 6, 12, 18, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.||units on a scale||Standard Deviation|Mean
753093|NCT00565812|Secondary|Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Stiffness Subscale Score at Month 3, 6, 12, 18 and 24|Stiffness was defined as a sensation of decreased ease in which the participant moved the knee with OA. The WOMAC stiffness subscale was comprised of 2 questions regarding the degree of stiffness experienced in the study knee. The WOMAC stiffness subscale score for each question ranged from 0 (minimum) to 4 (maximum), higher scores signified worse stiffness. An overall score range of 0 (minimum) to 8 (maximum), with higher scores indicating more stiffness.|Baseline, Month 3, 6, 12, 18, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.||units on a scale||Standard Deviation|Mean
753094|NCT00565812|Secondary|Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Subscale Score at Month 3, 6, 12, 18 and 24|The WOMAC pain subscale was comprised of 5 questions regarding the amount of pain experienced due to OA in the study knee. The WOMAC pain subscale score for each question ranged from 0 (minimum) to 4 (maximum), higher scores signified worse pain. An overall subscale score range of 0 (minimum) to 20 (maximum), with higher scores indicating more pain.|Baseline, Month 3, 6, 12, 18, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.||units on a scale||Standard Deviation|Mean
753095|NCT00565812|Secondary|Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index (WOMAC) Composite Index Score at Month 3, 6, 12, 18 and 24|The WOMAC was a self-administered, disease-specific instrument which probed clinically important, participant relevant symptoms in the areas of pain, stiffness, and physical function in participants with OA of the knee. The WOMAC composite index was the sum of 24 individual questions regarding subscales of pain, stiffness and physical function (for each item score range: 0 [minimum] to 4 [maximum], higher score indicating worse knee condition). Total score was sum of the 3 subscale scores, giving a possible overall score range of 0 (minimum) to 96 (maximum). Higher score indicating the worse level of pain, stiffness and physical function.|Baseline, Month 3, 6, 12, 18, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.||units on a scale||Standard Deviation|Mean
753096|NCT00565812|Primary|Rate of Progression of Joint Space Narrowing in Participants With Kellgren and Lawrence Grade Equal to (=) 3|Rate of progression of JSN was defined as narrowing in joint space width over the course of the study. It was measured radiographically in the medial tibiofemoral of knee of participants with OA. The slope reported in mm/year over a 2 year period was used to assess the rate of progression of JSN. KLG system was a method of classifying the severity of knee OA using five grades (0 [no severity] to 4 [maximum severity], higher grade indicating worse knee function). Negative values of slope indicating a worsening of osteoarthritis.|Baseline up to Month 24|FAS included all participants randomized to the study. Here, 'N' signifies participants with KLG =3 and evaluable for this outcome measure.||mm/year||Standard Deviation|Mean
753097|NCT00565812|Primary|Rate of Progression of Joint Space Narrowing in Participants With Kellgren and Lawrence Grade Less Than or Equal to (<=) 2|Rate of progression of JSN was defined as narrowing in joint space width over the course of the study. It was measured radiographically in the medial tibiofemoral of knee of participants with OA. The slope reported in mm/year over a 2 year period was used to assess the rate of progression of JSN. KLG system was a method of classifying the severity of knee OA using five grades (0 [no severity] to 4 [maximum severity], higher grade indicating worse knee function). Negative values of slope indicating a worsening of osteoarthritis.|Baseline up to Month 24|FAS included all participants randomized to the study. Here, 'N' signifies participants with KLG <=2 and evaluable for this outcome measure.||mm/year||Standard Deviation|Mean
753098|NCT00565812|Primary|Rate of Progression of Joint Space Narrowing|Rate of progression of joint space narrowing (JSN) was defined as narrowing in joint space width (JSW) over the course of the study. It was measured radiographically in the medial tibiofemoral of knee of participants with OA. The slope reported in millimeter per year (mm/year) over a 2 year period was used to assess the rate of progression of JSN. Negative values indicating a worsening of osteoarthritis.|Baseline up to Month 24|FAS included all participants randomized to the study. Here, 'number of participants analyzed' (N) signifies participants evaluable for this outcome measure.||mm/year||Standard Deviation|Mean
753540|NCT00577096|Primary|Number of Stem Cell Collection Attempts (Long Term)||up to 30 weeks|For the exercise group 8 participants who entered the study were not included in the analysis (2 withdrew from myeloma treatment, 1 died, 5 withdrew from study). For the usual care group 7 were not included in the analysis (3 withdrew from myeloma treatment, 1 died, 3 withdrew from study).||Stem Cell Collection Attempts||Standard Deviation|Mean
753099|NCT00566020|Secondary|Median Serum Lamotrigine 25, 100, 125, 150, 200, 225, 300, and 400 mg Concentrations Among Participants Without Concomitant Use of Inhibitor and Inducer|PK samples were collected at Weeks 6, 16, 28, 40, 52/EW, and the plasma lamotrigine concentrations were measured. Participants were required to visit the study site without taking the investigational product on the morning of the PK blood sampling. Inhibitors are defined as drugs that inhibit lamotrigine glucuronidation (i.e., valproate). Inducers are defined as drugs that induce lamotrigine glucuronidation (e.g., carbamazepine). The median value presented is the median of all samples collected at Weeks 6, 16, 28, 40, and 52/EW.|from Week 6 to Week 52/EW|Safety Population. Participants without concomitant use of inhibitor and inducer from the date of the first dose of study medication to the date of the last dose. Multiple blood samplings were conducted for some participants. A total of 82 participants were analyzed; 4 participants did not have 200 mg dose data but had data for lower doses.||Nanograms per milliliter||Full Range|Median
753100|NCT00566020|Secondary|Median Serum Lamotrigine 100 mg and 200 mg Concentration Among Participants With Concomitant Use of Inhibitor (at the Timing of Blood Sample Collection)|PK samples were collected at Weeks 6, 16, 28, 40, 52/EW, and the plasma lamotrigine concentrations were measured. Participants were required to visit the study site without taking the investigational product on the morning of the PK blood sampling. Inhibitors are defined as drugs that inhibit lamotrigine glucuronidation (i.e., valproate). The median value presented is the median of all samples collected at Weeks 6, 16, 28, 40, and 52/EW.|from Week 6 to Week 52/EW|Safety Population. Participants (par.) who took at least one dose of drugs that inhibit lamotrigine glucuronidation (i.e., valproate) from the date of the first dose of study medication to the date of the last dose. A total of 8 par. were analyzed; 1 par. had both 100 and 200 mg data, 4 par. had 100 mg data only, and 3 par. had 200 mg data only.||Nanograms per milliliter||Full Range|Median
753101|NCT00566020|Secondary|Median Serum Lamotrigine 200 mg Concentration Among Participants With Concomitant Use of Inducer and Without Inhibitor (at the Timing of Blood Sample Collection)|Pharmacokinetic (PK) samples were collected at Weeks 6, 16, 28, 40, 52/EW, and the plasma lamotrigine concentrations were measured. Participants were required to visit the study site without taking the investigational product on the morning of the PK blood sampling. Inhibitors are defined as drugs that inhibit lamotrigine glucuronidation (i.e., valproate). Inducers are defined as drugs that induce lamotrigine glucuronidation (e.g., carbamazepine). The median value presented is the median of all samples collected at Weeks 6, 16, 28, 40, and 52/EW.|from Week 6 to Week 52/EW|Safety Population. Participants who took at least one dose of drugs that induce lamotrigine glucuronidation (e.g., carbamazepine) from the date of the first dose of study medication to the date of the last dose.||Nanograms per milliliter||Full Range|Median
753102|NCT00566020|Secondary|Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Weeks 6, 16, 28, 40, and 52/EW|The YMRS is an 11-item, multiple-choice diagnostic questionnaire used to measure the severity of disease in participants. Individual items (1=elevated mood, 2=increased motor activity, 3=sexual interest, 4=sleep, 5=irritability, 6=speech, 7=language thought disorder, 8=content, 9=disruptive aggressive behaviour, 10=appearance, 11=insight) were rated on a scale of 0-4 and 0-8. YMRS total score (range of 0-60) was computed as sum of the scores for the 11 items on the scale. Change from baseline was calculated as the values at Week 6, 16, 28, 40, and 52 (or EW) minus the baseline value (Week 0).|Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW|FAS Population. OC and LOCF datasets were used for analysis. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).||scores on a scale||Standard Deviation|Mean
753103|NCT00566020|Secondary|Young Mania Rating Scale (YMRS) Total Score at Weeks 6, 16, 28, 40, and 52/EW|"The YMRS is an 11-item, multiple-choice diagnostic questionnaire used to measure the severity of disease in participants. Individual items (1=elevated mood, 2=increased motor activity, 3=sexual interest, 4=sleep, 5=irritability, 6=speech, 7=language thought disorder, 8=content, 9=disruptive aggressive behaviour, 10=appearance, 11=insight) were rated on a scale of 0-4 and 0-8. For all items, 0 is the best rating and 4 or 8 is the worst rating. YMRS total score was computed as the sum of the scores for the 11 items on the scale. The possible total scores range from 0 (best) to 60 (worst)."|Weeks 6, 16, 28, 40, and 52/EW|FAS Population. OC and LOCF datasets were used for analysis. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).||scores on a scale||Standard Deviation|Mean
753104|NCT00566020|Secondary|Change From Baseline in the Hamilton Rating Scale for Depression (HAM-D) Scale Total Score at Weeks 6, 16, 28, 40, and 52/EW|The HAMD-17 is a 17-item questionnaire that detects change and measures illness severity. Individual items were rated on a scale of 0-4 and 0-2, with the total HAMD-17 score ranging from 0 (not ill) to 52 (severely ill). Change from baseline was calculated as the values at Week 6, 16, 28, 40, and 52 (or EW) minus the baseline value (Week 0).|Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW|FAS Population. OC and LOCF datasets were used for analysis. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).||scores on a scale||Standard Deviation|Mean
753105|NCT00566020|Secondary|Hamilton Rating Scale for Depression (HAM-D) Scale Total Score at Weeks 6, 16, 28, 40, and 52/EW|The HAMD-17 is a 17-item questionnaire that detects change and measures illness severity. Individual items were rated on a scale of 0-4 and 0-2, with the total HAMD-17 score ranging from 0 (not ill) to 52 (severely ill).|Weeks 6, 16, 28, 40, and 52/EW|FAS Population. OC and LOCF datasets were used for analysis. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).||scores on a scale||Standard Deviation|Mean
753106|NCT00566020|Secondary|Change From Baseline in the Clinical Global Impressions of Severity (CGI-S) Total Score at Weeks 2, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW|The CGI-S is a standardized assessment tool that uses a 7-point scale to assess a participant's severity of illness. The total score ranges from 0 to 7: 0=not assessed, 1=normal, 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severly ill, 7=extremely ill. Higher scores reflect a higher severity of current illness states. Change from baseline was calculated as the values at Weeks 2, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 (or EW) minus the baseline value (Week 0).|Baseline (Week 0) and Weeks 2, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW|FAS Population. OC and LOCF datasets were used for analysis. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).||scores on a scale||Standard Deviation|Mean
753107|NCT00566020|Secondary|Clinical Global Impressions of Severity (CGI-S) Total Score at Weeks 0, 2, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW|The CGI-S is a standardized assessment tool that uses a 7-point scale to assess a participant's severity of illness. The total score ranges from 0 to 7: 0=not assessed, 1=normal, 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severly ill, 7=extremely ill. Higher scores reflect a higher severity of current illness states. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).|Weeks 0, 2, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW|Full Analysis Set (FAS): participants who received >=1 dose of study medication and underwent >=1 efficacy assessment. Observed Cases (OC; observed data with no imputation) and Last Observation Carried Forward (LOCF; data imputed [replaced] by most recent observed value [compared to planned date of missing observation]) were used for analysis.||scores on a scale||Standard Deviation|Mean
753108|NCT00566020|Primary|Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Weeks 0, 6, 28, and 52/EW|ECGs were recorded in participants at the indicated time points. ECG findings, as determined by the physicians, were reported as normal, abnormal but not clinically significant (NCS), abnormal but clinically significant (CS), and no result. Specific definitions of ECG categorizations were not provided; physicians were expected to apply reasonable standards of clinical judgment.|Weeks 0, 6, 28, and 52/EW|Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).||participants|||Number
753109|NCT00566020|Primary|Mean Body Mass Index (BMI) of All Participants at Week 0 (Baseline) and Weeks 6, 8, 12, 16, 20, 24, 28, 32,36, 40, 44, 48, and 52/EW|The BMI for participants was calculated at the indicated time points as body weight in kilograms divided by height in meters squared.|Baseline (Week 0) and Weeks 0, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW|Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).||Kilograms per meters squared||Standard Deviation|Mean
753110|NCT00566020|Primary|Mean Weight of Participants at Baseline (Week 0) and Weeks 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW|The weight of participants was recorded at the indicated time points.|Baseline (Week 0) and Weeks 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW|Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).||kilograms||Standard Deviation|Mean
753111|NCT00566020|Primary|Mean Heart Rate of Participants at Week 0 (Baseline) and Weeks 2, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW|Heart rate was measured in participants at the indicated time points.|Baseline (Week 0) and Weeks 2, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW|Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).||beat per minute||Standard Deviation|Mean
753112|NCT00566020|Primary|Mean Systolic Blood Pressure and Diastolic Blood Pressure of Participants at Baseline (Week 0) and Weeks 2, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW|Systolic and diastolic blood pressure was measured in participants at the indicated time points.|Baseline (Week 0) and Weeks 2, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW|Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).||Millimeters of mercury||Standard Deviation|Mean
753113|NCT00566020|Primary|Number of Participants in the Indicated Category for Urine Glucose, Urine Protein, and Urine Urobilinogen at Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW|Urine glucose, urine protein, and urine urobilinogen were measured in participants at the indicated time points. In this dipstick (qualitative) test, the level of glucose, protein, and urobilinogen in urine samples was recorded as negative (NEG [-]), trace (TRA [+/-]), 1+, 2+, 3+, 4+, and 5+ (the plus sign increases with a higher level of glucose, protein, or urobilinogen in the urine: 1+=slightly positive, 2+=positive, 3+=high positive, 4+=very high positive, 5+=more positive than 4+).|Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW|Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).||participants|||Number
753114|NCT00566020|Primary|Number of Participants With Clinical Laboratory Test Values Out of the Normal Range and in the Normal Range for Red Blood Cell Count at Weeks 0, 6, 16, 28, 40, and 52/EW|"Red blood cell count was measured in participants at the indicated time points. Participants were categorized as High for laboratory values above normal (reference) and as Low for laboratory values below normal ranges used by the central laboratory. Normal ranges: red blood cell count, Male: 4.38-5.77 TI (tebi; 10^12)/L, Female: 3.76-5.16 TI/L."|Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW|Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).||participants|||Number
753115|NCT00566020|Primary|Number of Participants With Clinical Laboratory Test Values Out of the Normal Range and in the Normal Range for Total Protein, Hemoglobin, and Hematocrit at Weeks 0, 6, 16, 28, 40, and 52/EW|"Participants in the study were evaluated for total protein, hemoglobin, and hematocrit at the indicated time points. Participants were categorized as High for laboratory values above normal (reference) and as Low for laboratory values below normal ranges used by the central laboratory. Normal ranges: total protein, 65-82 grams per liter (G/L); hemoglobin, Male: 136-183 G/L, Female: 112-152 G/L; hematocrit (proportion of 1), Male: 0.404-0.519, Female: 0.343-0.452."|Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW|Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).||participants|||Number
753116|NCT00566020|Primary|Number of Participants With Clinical Laboratory Test Values Out of the Normal Range and in the Normal Range for Platelet Count and White Blood Cell Count at Weeks 0, 6, 16, 28, 40, and 52/EW|"Participants in the study were evaluated for the following clinical laboratory parameters of hematology at the indicated time points: platelet count and white blood cell count. Participants were categorized as High for laboratory values above normal (reference) and as Low for laboratory values below normal ranges used by the central laboratory. Normal ranges: platelet count, 140-379 GI (gibi; 10^9) per liter (GI/L); white blood cell count, 3.5-9.7 GI/L."|Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW|Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).||participants|||Number
753117|NCT00566020|Primary|Number of Participants With Clinical Laboratory Test Values Out of the Normal Range and in the Normal Range for Calcium, Cholesterol, Chloride, Potassium, Sodium, Triglycerides, and Urea/Blood Urea Nitrogen (BUN) at Weeks 0, 6, 16, 28, 40, and 52/EW|"Participants were evaluated for the following clinical laboratory parameters for blood chemistry at the indicated time points: electrolytes (calcium, chloride, potassium, sodium), cholesterol, triglycerides, and urea/BUN. Participants were categorized as High for laboratory values above normal (reference) and as Low for laboratory values below normal ranges used by the central laboratory. Normal ranges (micromoles per liter [MMOL/L]): calcium, 2.0459-2.495; chloride, 98-108; potassium, 3.5-5; sodium, 135-145; cholesterol, 3.879-5.66334; triglycerides, 0.565-1.6837; urea/BUN, 2.856-7.14."|Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW|Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).||participants|||Number
753118|NCT00566020|Primary|Number of Participants With Clinical Laboratory Test Values Out of the Normal Range and in the Normal Range for Total Bilirubin and Creatinine at Weeks 0, 6, 16, 28, 40, and 52/EW|"Participants in the study were evaluated for the following clinical laboratory parameters at the indicated time points: total bilirubin and creatinine. Participants were categorized as High for laboratory values above normal (reference) and as Low for laboratory values below normal ranges used by the central laboratory. Normal ranges: total bilirubin, 3.42-17.1 micromoles per liter (UMOL/L); creatinine, Male: 57.46-96.356 UMOL/L, Female: 40.664-72.488 UMOL/L."|Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW|Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).||participants|||Number
753119|NCT00566020|Primary|Number of Participants With the Indicated Clinical Laboratory Test Values for Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH)|"Participants in the study were evaluated for the following clinical laboratory parameters at the indicated time points: ALP, ALT, AST, GGT, and LDH. Participants were categorized as High for laboratory values above normal (reference) and as Low for laboratory values below normal ranges used by the central laboratory. Normal ranges: ALP, 104-338 International Units per liter (IU/L); ALT, 5-45 IU/L; AST, 10-40 IU/L; GGT, Male: 0-79 IU/L, Female: 0-48 IU/L; LDH 120-245 IU/L."|Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/Early Withdrawal (EW)|Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).||participants|||Number
753120|NCT00566020|Primary|Number of Participants With Any Serious Adverse Event (SAE) and Any Non Serious Adverse Event|An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of medicinal product, which does not necessarily have a causal relationship with the treatment. An SAE is any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or causes its prolongation, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. A complete list of all SAEs and AEs experienced in the study can be found in the SAE/AE section.|From baseline (Week 0) until 2 weeks after the end of treatment (Week 54)|Safety Population: all participants who received at least one dose of study medication||participants|||Number
753121|NCT00566111|Secondary|Change in Ratings on the Clinical Global Impressions Scale for Bipolar Disorder (CGI-BP).|The number of patients that had a decrease on CGI-BP at 4 weeks.|4 weeks|only patients with complete data at 4 weeks were analyzed||participants|||Number
753122|NCT00566111|Secondary|Change in Montgomery Asberg Depression Rating Scale (MADRS)Score From Baseline.|The number of patients that had a decrease on MADRS at 4 weeks.|4 weeks|only participants with complete data at 4 weeks were analyzed||participants|||Number
753123|NCT00566111|Secondary|Number of Subjects Who Achieve Remission as Defined by a HDRS Score < 7.||4 weeks|only participants with complete data at 4 weeks were analyzed||participants|||Number
753124|NCT00566111|Secondary|Change in Score on the 16-item Quick Inventory of Depressive Symptoms (QIDS) From Baseline.|Number of patients with scores that decreased at four weeks.|4 weeks|These data were not collected.|||||
753125|NCT00566111|Primary|Change in Hamilton Depression Rating Scale (HDRS) Score From Baseline.|Number of patients with scores that decreased at four weeks.|4 weeks|only participants with complete data at 4 weeks were analyzed||participants|||Number
753126|NCT00566150|Secondary|Change in Clinical Global Impressions Scale for Bipolar Disorder (CGI-BP) Depression Severity Rating From Baseline at Week 6.|Change is observed value at each visit minus baseline value. CGI-BP depression severity is an instrument which measures severity of depression in bipolar disorder. Scale range: 1=normal, not ill; 7=very severely ill|Baseline to week 6|Weeks 1-6 are Intent to treat (ITT) population Observed Cases. All participants included received at least 1 dose of study intervention and at least 1 assessment post-baseline.||score on scale||Standard Error|Least Squares Mean
753127|NCT00566150|Secondary|Number of Subjects Who Achieve Remission.|"Remission response is measured as an HDRS-21 total score is less than or equal to 7.
HDRS-21 measures range of depressive symptoms. Endpoint is LOCF."|Week 6|||Participants|||Number
753128|NCT00566150|Secondary|Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline at Week 6.|Change is observed value at each visit minus baseline value. MADRS is a 10-item instrument measuring depression: scale range between 0(normal) - 6(most abnormal)for each item. Total possible score is 0 - 60.|Baseline to week 6|Weeks 1-6 are Intent to treat (ITT) population Observed Cases. All participants included received at least 1 dose of study intervention and at least 1 assessment post-baseline.||score on scale||Standard Error|Least Squares Mean
753129|NCT00566150|Primary|Change in Hamilton Depression Rating Scale (HDRS-21) Total Score From Baseline at Week 6.|Change is observed value at each visit minus baseline value. HDRS-21 is a 21-item instrument measuring depression. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 60.|Baseline to week 6|Weeks 1-6 are Intent to treat (ITT) population Observed Cases. All participants included received at least 1 dose of study intervention and at least 1 assessment post-baseline.||score on scale||Standard Error|Least Squares Mean
753541|NCT00577096|Primary|Number of Stem Cell Collection Attempts (Short Term)||up to 15 weeks|For the exercise group 8 participants who entered the study were not included in the analysis (2 withdrew from myeloma treatment, 1 died, 5 withdrew from study). For the usual care group 7 were not included in the analysis (3 withdrew from myeloma treatment, 1 died, 3 withdrew from study).||Stem Cell Collection Attempts||Standard Deviation|Mean
753131|NCT00566254|Secondary|Percent of Participants With =50% to < 75% and = 75% Decrease From Baseline in 28-day Seizure Frequency During the Maintenance Period(LOCF)|Participants' parent or guardian maintained a seizure diary recording the date, number, and type of seizures the subject had. Seizure frequency of simple partial, complex partial,and partial seizures with secondary generalization were assessed.|Baseline (Week -8 to Week 0) and Week 8 to Week 20|ITT Population||Percentage of Participants|||Number
753132|NCT00566254|Secondary|Median Percent Change From Baseline in the 28-day Seizure Frequency During the Maintenance Period (LOCF)|Participants' parent or guardian maintained a seizure diary recording the date, number,and type of seizures the subject had. Seizure frequency of simple partial,complex partial,and partial seizures with secondary generalization were assessed.|Baseline (Week -8 to Week 0) and Week 8 to Week 20|ITT Population||Percentage Change in Seizure Frequency||Full Range|Median
753133|NCT00566254|Primary|Percentage of Participants With a Decrease From Baseline in 28-day Seizure Frequency of =50%(Responder) in the Maintenance Period(LOCF)|A participant with a decrease from baseline in seizure frequency of =50 % was considered a responder. Participants' parent or guardian maintained a seizure diary recording the date, number, and type of seizures the subject had. The primary analysis assessed the percent of responders in the Maintenance Period (28- day seizure frequency in Week 8 to Week 20 compared to Week -8 to Week 0 at Last Observation Carried Forward (LOCF)). Seizure frequency of simple partial, complex partial, and partial seizures with secondary generalization were assessed.|Baseline (Week -8 to Week 0), and Week 8 to Week 20|The Intent to Treat (ITT)Population was defined as the group of randomized subjects who received at least one does of doubleblind study medication||Percentage of Participants|||Number
753134|NCT00566462|Secondary|Change in Caudate and Putamen [^123I]-IBZM Binding Following a Single Dose Carbidopa/Levodopa Challenge for 15-hours at Baseline and Week 4||Baseline and Week 4|This study was terminated at the sponsor request due to low enrollment.|||||
753135|NCT00566462|Primary|Change in Striatal [^123I]-Iodobenzamine (IBZM_ Binding Following a Single Dose Carbidopa/Levodopa Challenge for 15-hours at Baseline and Week 4||Baseline and Week 4|This study was terminated at the sponsor request due to low enrollment.|||||
753136|NCT00566501|Secondary|Mean Change From Baseline in SIB Score|The Severe Impairment Battery (SIB) evaluates the severity of cognitive dysfunction in patients with more advanced dementia.|12 months||||||
753137|NCT00566501|Secondary|Mean Change From Baseline in MMSE Score|The Mini-Mental State Examination (MMSE) is a brief, 30-item test of cognitive function.|12 months||||||
753138|NCT00566501|Primary|Long-term Safety as Measured by Incidence of Adverse Events During the 12 Month Treatment Period|Adverse events (AEs), including SAEs, were recorded from the time of consent. Recording of AEs ceased after the Final Visit or Early Termination Visit, except that SAEs were monitored for 30 days after study drug discontinuation.|Throughout the study ( 12 months for all AEs and up to an additional 30 days for SAEs)|The Safety Population consisted of all subjects who received at least one dose of donepezil SR 23 mg during Study 328. Two groups were categorized: those who received donepezil 10 mg IR and those who received donepezil 23 mg SR during Study 326.||participants|||Number
753139|NCT00566579|Primary|Number of Patients With Human Papillomavirus Clearance|At 12 months after treatment, a patient with negative results for HPV testing of previous types was considered as a clearance.|12 months|||participants|||Number
753140|NCT00566631|Other Pre-specified|Change From Baseline in Global Rating Sub-scale Score Based on Barnes Akathisia Rating Scale (BARS) at Day 7, 14, 42 and Final Evaluation (Day 42 or Early Discontinuation)|The BARS included an objective rating (from 0=normal to 3=constantly engaged), two subjective ratings of symptoms of akathisia, namely awareness of restlessness (ranging from 0=absence of inner restlessness to 3=awareness of intense compulsion to move) and reported distress related to restlessness (ranging from 0=no distress to 3=severe), and a global clinical rating of akathisia, ranging from 0 (absent) to 5 (severe). Global rating sub-scale score (that is, global clinical rating of akathisia) was assessed which was scored separately and is the most relevant measure of severity of akathisia. Higher scores indicates worsening akathisia. Final evaluation is the last post-baseline visit with data.|Baseline, Day 7, 14, 42 and Final Evaluation (Day 42 or early discontinuation)|"Safety population included all participants who received at least 1 dose of paliperidone ER and had at least 1 post-baseline safety assessment. “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and “n signifies those participants who were evaluated for this measure at given time points."||Units on a scale||Standard Deviation|Mean
753141|NCT00566631|Other Pre-specified|Change From Baseline in Simpson Angus Extrapyramidal Symptoms Rating Scale (SAS) Score at Day 7, 14, 42 and Final Evaluation (Day 42 or Early Discontinuation)|The SAS is a 10-item scale used to measure the symptoms of parkinsonism (slow movements) or parkinsonian side-effects related to the use of antipsychotic medications. The SAS rates 10 items (including gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, leg pendulousness, head dropping, Glabella tap, tremor and salivation), score ranging from 0 (normal) to 4 (extreme). The SAS global score is the average score (total sum of items score divided by the number of items) and ranges between 0 and 4, where the higher score indicates more severe condition of Extrapyramidal Symptoms. Final evaluation is the last post- baseline visit with data.|Baseline, Day 7, 14, 42 and Final Evaluation (Day 42 or early discontinuation)|"Safety population included all participants who received at least 1 dose of paliperidone ER and had at least 1 post-baseline safety assessment. “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and “n signifies those participants who were evaluated for this measure at given time points."||Units on a scale||Standard Deviation|Mean
753142|NCT00566631|Other Pre-specified|Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Score at Day 7, 14, 42 and Final Evaluation (Day 42 or Early Discontinuation)|The AIMS is a 12-item scale to provide a numeric measure to the observed abnormal movements in different parts of the body. Information is collected after a brief neurological examination and is scored on a 5-point scale (0=none and 4=severe). Final evaluation is the last post-baseline visit with data.|Baseline, Day 7, 14, 42 and Final Evaluation (Day 42 or early discontinuation)|"Safety population included all participants who received at least 1 dose of paliperidone ER and had at least 1 post-baseline safety assessment. “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and “n signifies those participants who were evaluated for this measure at given time points."||Units on a scale||Standard Deviation|Mean
769902|NCT00707577|Primary|Weight Loss|Mean number of pounds lost at the end of the 10-week program and 9-month maintenance program|1 year|||pounds||Standard Deviation|Mean
753143|NCT00566631|Secondary|Number of Participants Satisfied With the Study Treatment|Treatment satisfaction with paliperidone ER was assessed by the Investigator and participant on a 5-point scale: 1 (very good), 2 (good), 3 (reasonable), 4 (moderate) and 5 (poor), at the end of the core treatment phase (which is, Day 42 or early discontinuation) by conducting an interview.|Day 42 or early discontinuation|The ITT population included all participants who received at least 1 dose of paliperidone ER and provided at least 1 post-baseline efficacy measurement. “N” (number of participants analyzed) signifies those participants who were evaluable for this measure at given time point.||Participants|||Number
753144|NCT00566631|Secondary|Change From Baseline in Day Time Drowsiness Evaluation Score at Day 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)|The day time drowsiness evaluation scale is a self-administered scale that rates day time drowsiness. Participants indicate on an 11-point scale that how often they have felt drowsy within the previous 7 days, score ranged from 0 (not at all) to 10 (all the time). Final evaluation is the last post-baseline visit with data.|Baseline, Day 7, 14, 28, 42 and Final Evaluation (Day 42 or early discontinuation)|"The ITT population included all participants who received at least 1 dose of paliperidone ER and provided at least 1 post-baseline efficacy measurement. “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and “n signifies those participants who were evaluated for this measure at given time points."||Units on a scale||Standard Deviation|Mean
753145|NCT00566631|Secondary|Change From Baseline in Quality of Sleep Evaluation Score at Day 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)|The sleep evaluation scale is a self-administered scale that rates quality of sleep. Participants indicate on an 11-point scale that how well they have slept within the previous 7 days, score ranged from 0 (very badly) to 10 (very well). Final evaluation is the last post-baseline visit with data.|Baseline, Day 7, 14, 28, 42 and Final Evaluation (Day 42 or early discontinuation)|"The ITT population included all participants who received at least 1 dose of paliperidone ER and provided at least 1 post-baseline efficacy measurement. “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and “n signifies those participants who were evaluated for this measure at given time points."||Units on a scale||Standard Deviation|Mean
753146|NCT00566631|Secondary|Change From Baseline in Personal and Social Performance Scale (PSP) Score at Day 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)|The PSP assesses the degree of dysfunction within 4 domains of behavior: socially useful activities, personal & social relationships, self-care & disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (1, absent to 6, very severe) in each of 4 domains. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision. Final evaluation is the last post-baseline visit with data.|Baseline, Day 7, 14, 28, 42 and Final Evaluation (Day 42 or early discontinuation)|"The ITT population included all participants who received at least 1 dose of paliperidone ER and provided at least 1 post-baseline efficacy measurement. “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and “n signifies those participants who were evaluated for this measure at given time points."||Units on a Scale||Standard Deviation|Mean
753147|NCT00566631|Secondary|Change From Baseline in Clinical Global Impression -Severity (CGI-S) Score at Day 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to normal, not at all ill and a rating of 7 is equivalent to among the most extremely ill participants. Higher scores indicate worsening. Final evaluation is the last post-baseline visit with data."|Baseline, Day 7, 14, 28, 42 and Final Evaluation (Day 42 or early discontinuation)|"The ITT population included all participants who received at least 1 dose of paliperidone ER and provided at least 1 post-baseline efficacy measurement. “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and “n signifies those participants who were evaluated for this measure at given time points."||Units on a scale||Standard Deviation|Mean
753148|NCT00566631|Secondary|Percentage of Participants With Treatment Response Greater Than (>) 20 Percent, 40 Percent and 50 Percent in Total Positive and Negative Syndrome Scale (PANSS) Score|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening. Final evaluation is the last post-baseline visit with data.|Day 2, 3, 4, 5, 7, 14, 28, 42 and Final Evaluation (Day 42 or early discontinuation)|The ITT population included all participants who received at least one dose of paliperidone ER and provided at least 1 post-baseline efficacy measurement.||Percentage of participants|||Number
753149|NCT00566631|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Day 42 and Final Evaluation (Day 42 or Early Discontinuation)|The PANSS is a 30-item scale to assess neuropsychiatric symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). Positive symptoms subscale consists of 8 items with total score range of 8-56; negative symptoms and disorganized thoughts subscale, consists of 7 items with total score range of 7-49, uncontrolled hostility/excitement (H/E) subscale and anxiety/depression subscale, each consists of 4 items with total score range of 4-28. Higher score indicates greater severity. Final evaluation is the last post-baseline visit with data.|Baseline, Day 42 and Final Evaluation (Day 42 or early discontinuation)|The ITT population included all participants who received at least one dose of paliperidone ER and provided at least 1 post-baseline efficacy measurement.||Units on a scale||Standard Deviation|Mean
753167|NCT00566722|Secondary|Percent Impairment While Working Due to Psoriasis|Percent impairment while working was evaluated using the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP), described above. At Screening, impairment while working ranged from 0% to 90%. A decrease in percent impairment indicates improvement.|From Screening to Week 16|All participants who received at least 1 dose of study drug were included. Last observation carried forward was used for missing data. Screening data were not available for all participants.||Change in % impairment while working||Standard Deviation|Mean
755309|NCT00593606|Primary|Change in Gamma-Glutamyltransferase|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||Units/l||Standard Deviation|Mean
753150|NCT00566631|Secondary|Change From Baseline in Total Positive and Negative Symptom Scale (PANSS) Score at Day 2, 3, 4, 5, 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening. Final evaluation is the last post-baseline visit with data.|Baseline, Day 2, 3, 4, 5, 7, 14, 28, 42 and Final Evaluation (Day 42 or early discontinuation)|"The ITT population included all participants who received at least one dose of paliperidone ER and provided at least 1 post-baseline efficacy measurement. “n signifies those participants who were evaluated for this measure at given time points."||Units on a scale||Standard Deviation|Mean
753151|NCT00566631|Primary|Number of Participants With Treatment Response Based on Total PANSS Scale Score|Response was defined as decrease of at least 30 percent in total Positive and Negative Syndrome Scale (PANSS) score from Baseline to endpoint of core phase (which is, Day 42 or early discontinuation). The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, & poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of sum of all 30 PANSS items & ranges from 30 to 210. Higher scores indicate worsening.|Day 42 or early discontinuation|Intent-to-treat (ITT) population included all participants who received at least one dose of paliperidone ER and provided at least 1 post-baseline efficacy measurement.||Participants|||Number
753152|NCT00566696|Secondary|To Estimate the Rate of Overall Grade III-IV Acute GVHD, and the Rate and Severity of Chronic GVHD in Research Participants.||five years post-transplant||||||
753153|NCT00566696|Secondary|To Estimate the Cumulative Incidence of Relapse for Research Participants Who Receive This Study Treatment.||five years post-transplant||||||
753154|NCT00566696|Secondary|Incidence of Regimen-related Mortality|The incidence of regimen-related mortality in the first 100 days post-transplant is estimated based on binomial distribution.|100 days post-transplant|||Percentage of participants|||Number
753155|NCT00566696|Secondary|Incidence of Non-hematologic Regimen-related Toxicities|Estimate of the incidence of non-hematologic regimen-related toxicity and regimen-related toxicity in the first 100 days post-transplant. The percentage of participants are reported by maximum grade seen using binomial distribution. Participants were graded for toxicity using Common Terminology Criteria for Adverse Events version 3.0. In general, Grade 1 is mild, 2 is moderate toxicity but generally does not require treatment, 3 is severe enough to require treatment, 4 is life-threatening, and 5 means it was associated with death.|100 days post-transplant|||percentage of participants|||Number
753156|NCT00566696|Secondary|Disease-Free Survival (DFS)|Estimate the one-year disease-free survival (DFS) for research participants who receive this study treatment. DFS is defined as time from transplantation to the occurrence of relapse or death due to relapse. Patients who are alive at the time of analysis or die due to other causes will be censored at the time of their events. The estimated percentage of participants with DFS at one-year post-transplantation is reported using Kaplan-Meier analysis.|One year post-transplant|||Percentage of participants|||Number
753157|NCT00566696|Secondary|Overall Survival (OS)|Estimate the one-year overall survival (OS) for research participants who receive this study treatment. OS is defined as time from transplantation to death due to any cause. Patient who are alive at the time of analysis will be censored. The estimated percentage of participants with OS at one-year post-transplantation is reported using Kaplan-Meier analysis.|one year post-transplant|||Percentage of participants|||Number
753158|NCT00566696|Primary|Event-free Survival (EFS)|To determine if one year event-free survival can be improved in pediatric patients undergoing a haploidentical transplant by using a reduced intensity conditioning regimen and a targeted dose T cell depleted donor product. EFS is defined as time from transplantation to the occurrence of relapse or death due to any cause. Patients who are alive at the time of analysis will be censored. The estimated percentage of participants with EFS at one-year post-transplantation is reported using Kaplan-Meier analysis.|one year post-transplant|||Percentage of participants|||Number
753159|NCT00566709|Secondary|Unfavorable Glasgow Outcome Scale (GOS)|"GOS measures the degree of disability associated with the brain injury
Unfavorable GOS included the categories of:
death.
vegetative status.
severe disability."|At hospital discharge, an average of 21 days|||participants|||Number
753160|NCT00566709|Secondary|Long-term Mortality||1-year after hospital discharge|||participants|||Number
753161|NCT00566709|Secondary|Length of Intensive Care Unit (ICU) Stay||The length of ICU stay, an avarege of 17 days|||days||Standard Deviation|Mean
753162|NCT00566709|Secondary|Hospital Mortality||length of the hospital stay, an average of 20 days|||participants|||Number
753163|NCT00566709|Primary|Percentage of Transfused Patients in Each Group||duration of the protocol, an average of 15 days|||percentage of transfused participant|||Number
753164|NCT00566709|Primary|Number of Units of Packed Red Blood Cell Transfused|Number of units of packed packed red blood cell transfused, over the period that the patient was included into the protocol|duration of the protocol, an average of 15 days|||units||Standard Deviation|Mean
753165|NCT00566722|Secondary|Sleep Problems Index II|"Sleep Problems Index of the Sleep Scale from the Medical Outcomes Study reflects sleep disturbance, perceived sleep adequacy, daytime somnolence, and awakening short of breath or with headache. Participant rates each item from none of the time to all of the time for the previous 4 weeks. Scores are transformed to 0 to 100 scale; lower scores indicate less impairment. Decrease in score indicates improvement."|From Screening to Week 16|All participants who received at least 1 dose of study drug were included. Last observation carried forward was used for missing data. Screening data were not available for all participants for all items; as a result, not all participants were included in the analysis.||Change in scores on a scale||Standard Deviation|Mean
753166|NCT00566722|Secondary|Percent Activity Impairment Due to Psoriasis|Percent impairment in regular activities was evaluated using the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP), described above. At Screening, activity impairment due to psoriasis ranged from 0% to 90%.|From Screening to Week 16|All participants who received at least 1 dose of adalimumab were included. Last observation carried forward was using for missing data. Screening data were not available for all participants.||Change in percent activity impairment||Standard Deviation|Mean
753168|NCT00566722|Secondary|Percent Overall Work Impairment Due to Psoriasis|Percent overall work impairment was evaluated using the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP) (described above). At Screening, overall impairment ranged from 0% to 94%. A decrease in percent overall work impairment indicates improvement.|From Screening to Week 16|All participants who received at least 1 dose of adalimumab were included. Last observation carried forward was used for missing data. Screening data were not available for all participants.||Change in % overall work impairment||Standard Deviation|Mean
753169|NCT00566722|Secondary|Percent Work Time Missed Due to Psoriasis|Work and activity impairment due to psoriasis were evaluated using the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP), a 6-item questionnaire that measures effect of psoriasis on number of hours worked and the number of hours missed from work. It also measures the effect on productivity and regular activities: 0=no effect on work/daily activities; 10=psoriasis prevented me from working/doing daily activities. Decreases in values on each part indicate improvement. At Screening, percent time missed in the previous week ranged from 0% to 40%.|From Screening to Week 16|All participants who received at least 1 dose of adalimumab are included. Last observation carried forward was used for missing data. Screening data were not available for all participants.||Change in percent time missed||Standard Deviation|Mean
753170|NCT00566722|Secondary|Visual Analog Scale (VAS) for Pain Involving Psoriatic Plaques and/or Psoriatic Arthritis|The participant rates his/her pain during the previous week on a 100 mm VAS, from 0=no pain to 100=pain as bad as it could be. A decrease in score indicates improvement.|From Screening to Week 16|All participants who received at least 1 dose of adalimumab were included. Last observation carried forward was used for missing data.||Change in scores on a scale||Standard Deviation|Mean
753171|NCT00566722|Secondary|Psoriasis-related Pruritus Assessment|The Psoriasis-related Pruritus Assessment is a scale for evaluating pruritus-related to psoriasis over the previous week; values range from 0 (no itching) to 10 (severe itching). A decrease in score indicates an improvement in pruritus.|From Screening to Week 16|All participants who received at least 1 dose of study drug were included. Last observation carried forward was used for missing data.||Change in scores on a scale||Standard Deviation|Mean
753172|NCT00566722|Secondary|Number of Participants Achieving DLQI Total Score of 0 at Week 4 and Week 16|DLQI total score of 0 indicates psoriasis had no effect at all on participant's life.|Week 4 and Week 16|All participants who received at least 1 dose of adalimumab were included. Nonresponder imputation (score of 0 not achieved) was used for missing data.||Participants|||Number
753173|NCT00566722|Secondary|Dermatology Life Quality Index (DLQI) Total Score|The DLQI has 10 items and 6 subscales: symptoms and feelings (Q 1 and 2), daily activities (Q 3 and 4), leisure (Q 5 and 6), work and school (Q 7), personal relationships (Q 8 and 9), and treatment (Q 10). Participants rate how much their skin problem affected their life in previous week. Responses are 0 (not at all) to 3=very much. DLQI=total of scores for all items; max=30; min=0.|From Screening to Week 4 and Week 16|All participants who received at least 1 dose of adalimumab were included. Last observation carried forward was used for missing data.||Change in scores on a scale||Standard Deviation|Mean
753174|NCT00566722|Secondary|Number of Participants Achieving 0 or 1 on Patient's Global Assessment at Weeks 2, 4, and 8|The Patient's Global Assessment of Psoriasis-Severity is a rating of how well their disease is controlled. 0=complete disease control; 1=good disease control; 2=limited disease control; 3=uncontrolled disease.|Weeks 2, 4, and 8|All participants who received at least 1 dose of adalimumab are included. Nonresponder imputation was used for missing data; that is, participants who did not have an evaluation at the time point were assumed to not have achieved a 0 or 1 on the PGA.||Participants|||Number
753175|NCT00566722|Secondary|Number of Participants Achieving at Least 1 Grade of Improvement in PGA at Week 16 Compared to Screening||From Screening to Week 16|All participants who were enrolled and received a dose of adalimumab were included. Non-responder imputation (1 grade of improvement not achieved) was used for missing data.||Participants|||Number
753176|NCT00566722|Secondary|Number of Participants Achieving a PGA of Clear (0) at Week 16||Week 16|All participants who received at least 1 dose of adalimumab were included. Nonresponder imputation (PGA of clear [0] not achieved) was used for missing data.||Participants|||Number
753177|NCT00566722|Primary|Number of Participants Who Achieved a Physician's Global Assessment (PGA) of Clear (0) or Minimal (1) at Week 16|The PGA is a 6-point scale used to measure the severity of a patient's disease. Plaque elevation, scaling, and erythema are rated from 0= clear (no plaque elevation; no scaling; erythema=hyperpigmentation, pigmented macules, diffuse faint pink or red coloration) to 5=very severe (plaque elevation=very marked; scaling=very coarse; erythema=very severe [extreme red coloration, dusky to deep red coloration]).|Week 16|All participants who received at least 1 dose of adalimumab were included. Nonresponder imputation (PGA of clear or minimal not achieved) was used for missing data.||Participants|||Number
753178|NCT00566735|Secondary|Baseline Depressive Symptoms|This measure refers to the Hamilton Rating Scale for Depression-17 scores (HAM-D-17) which can range from 0 to 50, with <7 referring to mild-to-no depression, and >23 referring to severe depression.|Participants were questioned at baseline|||Score on the HAM-D-17||Standard Deviation|Mean
753179|NCT00566735|Secondary|Cognitive Functioning|This measure refers to participants' scores on the Delayed Memory Index (DMI) compared from baseline (before first ECT) to discharge (after last ECT). The score can range from 40 to 137. The higher the score, the better, in terms of cognitive functioning.|Participants were questioned at baseline and after their last electroconvulsive therapy treatment|||Score on the DMI||Standard Deviation|Mean
753180|NCT00566735|Primary|Number of Side Effects|This measure refers to the number of reported side effects experienced by participants during the study. The side effects were nausea, headache, dizziness, diarrhea, and vomiting.|Participants were followed for the duration of hospital stay, an average of 3 weeks|||Number of reported side effects|||Number
753181|NCT00566852|Secondary|Overall Survival|Failure for overall survival is death from any cause. Median survival was estimated using the Kaplan-Meier method.|From randomization to date of death or last follow-up. Analysis occurs at the same time as the primary outcome. Patients are followed until death and all follow-up collected at time of analysis is used.|All eligible patients||months||95% Confidence Interval|Median
753198|NCT00566982|Secondary|Change From Baseline in Estradiol Levels||52 weeks|ITT||nmol/L||Standard Deviation|Mean
753199|NCT00566982|Primary|Mean Change From Baseline in Vaginal pH||12 weeks|ITT||pH||Standard Deviation|Mean
753182|NCT00566852|Secondary|Median Progression-free Survival Time|Disease progression is defined as the first of the following events: an increase of at least 50% for lesions less than or equal to 1cm, an increase of least 25% for lesions greater than 1cm, appearance of any new brain metastases. Failure for progression-free survival is disease progression or death. Median progression-free survival was estimated using the Kaplan-Meier method.|From randomization to date of progression, death or last follow-up. Analysis occurs at the same time as the primary outcome. Patients are followed until death and all follow-up collected at time of analysis is used.|All eligible patients||months||Inter-Quartile Range|Mean
753183|NCT00566852|Secondary|Change in Functional Assessment of Cancer Therapy With Brain Subscale (FACT-Br) at 24 Weeks|The FACT-Br is a 50-question self-report questionnaire contains the following domains (scales): Physical well-being (7 questions), social/family well-being (7 questions), emotional well-being (6 questions), functional well-being (7 questions) and brain cancer subscale which contains concerns relevant to patients with brain tumors (23 questions). Each question has a value 0-4. For some questions a higher indicates better outcome and others are the opposite. The former are summed as is, the latter are reversed in value before adding, such that each domain ranges from 0 to 4 times the number of questions in the domain, with 0 indicating worst and the highest possible value indicating best outcome. The FACT-Br total is obtained by adding all domains together if the overall question response rate is greater than 80%. Total scores on the FACT-Br range from 0 to 184 with lower scores indicating declining quality of life. Change is calculated as baseline score subtracted from 24-week score.|Baseline and 24 weeks from start of treatment|Eligible patients with FACT-Br score at baseline and 24 weeks.||units on a scale||Inter-Quartile Range|Median
753184|NCT00566852|Secondary|Median Time to Neurocognitive Failure|Neurocognitive failure is defined as the first cognitive failure on any of the neurocognitive tests: the HVLT-R for immediate recall, delayed recognition, and delayed recall; the Controlled Oral Word Association Test (COWAT); the Trail-Making Test (TMT) Parts A and B. Cognitive failure for each test is defined as a post-treatment score that meets one of the following criteria: follow-up score is at least 2 standard deviations worse than the patient’s personal baseline score or the patient’s raw score change is greater than the reliable change index. The cumulative incidence approach was used to estimate the median time to neurocognitive failure to account for the competing risks of disease progression and death.|Baseline to 12 months from the start of drug treatment|All randomized eligible patients with neurocognitive scores from baseline to 12 months from start of drug treatment.||years||95% Confidence Interval|Median
753185|NCT00566852|Secondary|Change in the Hopkins Verbal Learning Test - Revised for Delayed Recall (HVLT-R-delayed Recall) at 8, 16, and 52 Weeks|The HVLT-R consists of 3 parts. Free call has a range of 0 to 36, delayed recall has a range from 0 to 12, and delayed recognition has a range of -12 to 12. Higher scores indicating better function in all 3 parts. Standardized scores are used by calculating an average standardized z score for each part of the HVLT-R. Change is calculated by subtracting baseline value from the respective later time point value. Imputation methods were used to determine values for all alive patients missing the post-baseline assessments. This tool is being used to measure cognitive function, specifically memory.|Baseline, 8, 16, and 52 weeks from the start of drug treatment|Eligible patients with baseline and respective post-baseline measurements||units on a scale||Inter-Quartile Range|Median
753186|NCT00566852|Primary|Change in the Hopkins Verbal Learning Test - Revised for Delayed Recall (HVLT-R-delayed Recall) at 24 Weeks|The HVLT-R consists of 3 parts. Free call has a range of 0 to 36, delayed recall has a range from 0 to 12, and delayed recognition has a range of -12 to 12. Higher scores indicating better function in all 3 parts. Standardized scores are used by calculating an average standardized z score for each part of the HVLT-R. Change is calculated by subtracting baseline value from 24-week value. Imputation methods were used to determine values for all alive patients missing the 24 week assessment. This tool is being used to measure cognitive function, specifically memory.|Baseline and 24 weeks from the start of drug treatment|All eligible patients with Hopkins Verbal Learning Test-Revised for delayed recall (HVLT-R delayed recall) at baseline and 24 weeks.||units on a scale||Inter-Quartile Range|Median
753187|NCT00566930|Primary|Neck Pain|Visual analog pain scale (score 0-10 cm; 0 being no neck pain and 10 extreme neck pain)|Up to 10 months|||cm||Standard Deviation|Mean
753188|NCT00566930|Secondary|Fear Avoidance Belief, Quality of Life, Range of Motion||One year||||||
753189|NCT00566943|Secondary|Number of Participants With Stricture Requiring Intervention Between Control Group and PSD Veritas Group. Bleeding Assessment of Control Group to PSD Veritas.|Stricture requiring intervention comparison between control group and PSD Vertas group. Bleeding assessment comparison of control group to PSD Veritas Group. These results will combine both stricture and bleeding since this was how it was entered in to the database.|Discharge, 30 and 90 days|||participants|||Number
753190|NCT00566943|Secondary|Linear Arm: Comparison of Use of Endoclips or Sutures Used for Bleeding in Control Group Versus PSD Veritas Group|Comparison of number of subjects who required use of Endoclips or sutures for bleeding in Control group versus the number of subjects who required use of Endoclips or sutures for bleeding in PSD Veritas group in the linear arm of the study.|Discharge and 30 days|||Participants|||Number
753191|NCT00566943|Primary|Linear and Circular Arm: Number of Participants With a Leak as Determined by a Comparison of Control Group to PSD Veritas Group.|Leak as determined by a comparison of control group to PSD Veritas group in both linear and circular arms.|Discharge/30 Linear Discharge/30/90 days Circular|||Participants|||Number
753192|NCT00566943|Primary|Linear and Circular Arm: Number of Subjects With Major Gastric Related Adverse Events Comparison Between Control and PSD Veritas Groups.|Adverse events as measured through hospital discharge and 30 days post-discharge in both the linear and circular arms of the study.|Discharge/ 30 days Linear Discharge/30/90 days Circular|||Participants|||Number
753193|NCT00566969|Primary|Percent Days Abstinent From Cocaine - Self Report|Percent Self reported days of abstinence from any cocaine use during the 11 week trial.|11 weeks|||percentage of days||Standard Deviation|Mean
753194|NCT00566982|Secondary|Visual Evaluation of the Vagina (Baseline & Week 52)||52 weeks|ITT||participants|||Number
753195|NCT00566982|Secondary|Change From Baseline in Sex Hormone Binding Globulin Levels||52 weeks|ITT||nmol/L||Standard Deviation|Mean
753196|NCT00566982|Secondary|Change From Baseline in Follicle Stimulating Hormone Levels||52 weeks|ITT||U/L||Standard Deviation|Mean
753197|NCT00566982|Secondary|Change From Baseline in Luteinizing Hormone Levels||52 weeks|ITT||U/L||Standard Deviation|Mean
753203|NCT00566995|Primary|Overall Response Rate.|Overall response rate is defined as the percentage of participants with either a partial or complete response occurring at any time after initiation of therapy. Response is determined by the Response Evaluation Criteria in Solid Tumors (RECIST). Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Complete response (CR) is a disappearance of all target lesions. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (progressive disease), taking as reference the smallest sum LD since the treatment started.|cycle 3, day 28|||percentage of participants|||Number
753204|NCT00567008|Primary|Evidence of Abstinence From Cocaine as Indicated by Qualitative Urinalysis for Benzoylecgonine.|Number of Participants that Tested Negative for Benzoylecgonine in Qualitative Urinalysis Assessment.|8 weeks|||participants|||Number
753205|NCT00567112|Secondary|t1/2 for OCT (Fasted) and OCT (After Meal)||From study drug administration to 72 hours post-administration|Participants with t1/2 measurements||hours||Full Range|Median
753206|NCT00567112|Secondary|Tmax for OCT (Fasted) and OCT (After Meal)||From study drug administration to 72 hours post-administration|Participants with Tmax measurements||hours||Full Range|Median
753207|NCT00567112|Primary|Half Life (t½) for OCT (Fasted) and DFC (Fasted)||From study drug administration to 72 hours post-administration|Participants with t1/2 measurements||hours||Full Range|Median
753208|NCT00567112|Primary|Time to Reach Cmax (Tmax) for OCT (Fasted) and DFC (Fasted)||From study drug administration to 72 hours post-administration|Participants with Tmax measurements||hours||Full Range|Median
753209|NCT00567112|Secondary|Cmax of OCT (Fasted) and OCT (After Meal)||From study drug administration to 72 hours post-administration|Participants with Cmax measurements||nM||Full Range|Least Squares Mean
753210|NCT00567112|Secondary|AUC(0-∞) for OCT (Fasted) and OCT (After Meal)||From study drug administration to 72 hours post-administration|Participants with AUC(0-∞) measurements||nM*hr||Full Range|Least Squares Mean
753211|NCT00567112|Primary|Maximum Concentration (Cmax) for OCT (Fasted) and DFC (Fasted)||From study drug administration to 72 hours post-administration|Participants with Cmax measurements||nM||Full Range|Least Squares Mean
753212|NCT00567112|Primary|Area Under the Curve (AUC)(0-∞) for Oral Compressed Tablet (OCT) (Fasted) and Dry Filled Capsule (DFC) (Fasted)||From study drug administration to 72 hours post-administration|Participants with AUC(0-∞) measurements||nM*hr||Full Range|Least Squares Mean
753213|NCT00567164|Secondary|Length of Cycles|Cycle length per cycle. For the flexible and stop and go extended treatment arms, a treatment cycle started with the first day of pill intake after a tablet-free interval and ended with the last day of the subsequent tablet-free interval. A tablet-free interval (treatment withdrawal) was defined as at least 3 consecutive days without tablet intake. For the standard 24+4 treatment arm, a new cycle started each time a new blister pack of medication was started.|Up to 1 year|Full Analysis Set (ie, all treated participants). Only cycle data from participants with sufficient data to calculate cycle length are included.||Days|Participants|Standard Deviation|Mean
753214|NCT00567164|Secondary|Number of Scheduled and Unscheduled Bleeding Days|Scheduled bleeding is any bleeding/spotting (bl/sp) that occurs during the tablet free interval through the next 4 days of the subsequent treatment cycle. Unscheduled bleeding is any bl/sp that occurs while taking active hormones, except for bl/sp that occurs during the tablet free interval through day 4 of the subsequent treatment cycle or bl/sp on days 1-7 of treatment cycle 1.|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding and tablet intake data sufficient to calculate scheduled/unscheduled bleeding. Analysis was only performed for the flexible and stop-and-go extended regimens.||Days||Standard Deviation|Mean
753215|NCT00567164|Secondary|Number of Intracyclic Bleeding Days|Intracyclic bleeding was considered any bleeding/spotting that occurred between withdrawal bleedings.|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding and tablet intake data sufficient to calculate intracyclic bleeding.||Days||Standard Deviation|Mean
753216|NCT00567164|Secondary|Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 14|A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE. There were no participants who received treatment in cycle 14 in the Flexible (extended) regimen no.1 of EE20/DRSP (BAY86-5300). There were no participants who provided bleeding data for cycle 14 in the Flexible (extended) regimen no.2 of EE20/DRSP (BAY86-5300), although one woman did receive 14 cycles of treatment.|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 14.||Percentage of Participants|||Number
753217|NCT00567164|Secondary|Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 13|A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE. There were no participants who provided bleeding data for cycle 13 in the Flexible (extended) regimen no.1 of EE20/DRSP (BAY86-5300), although one women did receive 13 cycles of treatment.|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 13.||Percentage of Participants|||Number
753562|NCT00577135|Secondary|Change in Cystatin C||baseline and day 7|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.||mg/L||Standard Deviation|Mean
753218|NCT00567164|Secondary|Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 12|A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 12.||Percentage of Participants|||Number
753219|NCT00567164|Secondary|Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 11|A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 11.||Percentage of Participants|||Number
753220|NCT00567164|Secondary|Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 10|A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 10.||Percentage of Participants|||Number
753221|NCT00567164|Secondary|Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 9|A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 9.||Percentage of Participants|||Number
753222|NCT00567164|Secondary|Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 8|A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 8.||Percentage of Participants|||Number
753223|NCT00567164|Secondary|Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 7|A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 7.||Percentage of Participants|||Number
753224|NCT00567164|Secondary|Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 6|A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 6.||Percentage of Participants|||Number
753225|NCT00567164|Secondary|Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 5|A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 5.||Percentage of Participants|||Number
753273|NCT00567268|Other Pre-specified|Number of Participants Who Responded to Treatment With Gabapentin by Age (<65 Versus >=65 Years)|Participants who responded to the treatment with gabapentin were counted by age (<65 vs. >=65 years) to assess whether the age was a factor affecting the treatment efficacy.|12 weeks|The efficacy analysis population comprised of the participants who had at least one post-baseline efficacy evaluation for the clinical efficacy and seizure frequency in the safety analysis population. Participants who had diseases not eligible for the survey were excluded from the efficacy analysis population.||participants|||Number
753226|NCT00567164|Secondary|Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 4|A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 4.||Percentage of Participants|||Number
753227|NCT00567164|Secondary|Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 3|A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 3.||Percentage of Participants|||Number
753228|NCT00567164|Secondary|Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 2|A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 2.||Percentage of Participants|||Number
753229|NCT00567164|Secondary|Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 1|A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 1.||Percentage of Participants|||Number
753230|NCT00567164|Secondary|Number of Days With Bleeding/ (Including and Excluding Spotting) Within 90-day Reference Period 4|Number of days per participant with bleeding (including and excluding spotting) within 90-day reference period 4. Reference period 4 (Day 271 to Day 360) was a 90-day period that started with the intake of study medication at the beginning of Cycle 10.|Day 271 to Day 360|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for reference period 4.||Days||Standard Deviation|Mean
753231|NCT00567164|Secondary|Number of Days With Bleeding (Including and Excluding Spotting) Within 90-day Reference Period 3|Number of days per participant with bleeding (including and excluding spotting) within 90-day reference period 3. Reference period 3 (Day 181 to Day 270) was a 90-day period that started with the intake of study medication at the beginning of Cycle 7.|Day 181 to Day 270|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for reference period 3.||Days||Standard Deviation|Mean
753232|NCT00567164|Secondary|Number of Days With Bleeding (Including and Excluding Spotting) Within 90-day Reference Period 2.|Number of days per participant with bleeding (including and excluding spotting) within 90-day reference period 2. Reference period 2 (Day 91 to Day 180) was a 90-day period that started with the intake of study medication at the beginning of Cycle 4.|Day 91 to Day 180|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for reference period 2.||Days||Standard Deviation|Mean
753233|NCT00567164|Secondary|Number of Days With Bleeding (Including and Excluding Spotting) Within 90-day Reference Period 1.|Number of days per participant with bleeding (including and excluding spotting) within 90-day reference period 1. Reference period 1 (Day 1 to Day 90) was a 90 day period starting with the initial intake of study medication (protocol-specified to occur on first day of menstrual or withdrawal bleeding after screening). Therefore, the first 90-day reference period contains additional bleeding days (associated with the menstrual cycle prior to the start of study medication) when compared to any other reference period.|Day 1 to Day 90|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for reference period 1.||Days||Standard Deviation|Mean
753234|NCT00567164|Secondary|Number of Bleeding Days (Excluding Spotting Days)|Number of days per participant with bleeding (excluding spotting days)|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data.||Days||Standard Deviation|Mean
753235|NCT00567164|Secondary|Number of Bleeding Days (Including Spotting Days)|Number of days per participant with bleeding or spotting|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data.||Days||Standard Deviation|Mean
753244|NCT00567242|Secondary|Category Member Generation Probe Scores (% Accuracy)|Improvement for the time series from 8 baseline sessions through 30 treatment sessions for naming probes was computed with the C statistic using Tryon's (1982, 1983) formula for each subject. C statistics were converted to Z scores, using the formula provided by Tryon (1982). Z scores indicated treatment change for each subject, with a positive and significant Z score indicating substantive treatment gains. Z scores were then compared between groups with a t statistic. It was expected that the intention manipulation would lead to greater treatment gains than when it was not used.|trend for time series of 8 baseline + 30 treatment sessions|Data from all subjects completing their respective arms were analyzed, with the exception of one control subject whose baseline was not stable.||Z score||Standard Deviation|Mean
753236|NCT00567164|Primary|Pearl Index|The Pearl Index (PI) is the number of pregnancies per 100 woman years. The PI is obtained by dividing the number of pregnancies during treatment (conception date on/after the 1st day of treatment and not later than last day of treatment +14 days) by the treatment exposure time (in 100 women years) that the women were under risk of getting pregnant. The Pearl Index was not calculated individually for either the Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) treatment arm, nor for the Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300) treatment arm, because the low sample size in these treatment arms (approximately. 200 subjects per group) did not allow a reliable PI calculation of these groups alone.|Up to 1 year|Full Analysis Set of Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) treatment arm. Pooled Full Analysis Sets of Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) and Regimen no. 2 of EE20/DRSP (BAY86-5300) treatment arms.||Pregnancies per 100 years of exposure||95% Confidence Interval|Mean
753237|NCT00567190|Secondary|Time to Symptom Progression|Time to symptom progression was defined as the time from randomization to the first symptom progression as measured by the Functional Assessment of Cancer Therapy-for patients with Breast Cancer (FACT-B) questionnaire with the Trial Outcomes Index-Physical/Functional/Breast (TOI-PFB) subscale. The FACT-B TOI-PFB subscale contains 24 items from 3 subsections of the FACT-B questionnaire: Physical well-being, functional well-being, and additional concerns for breast cancer patients (breast cancer subscale [BCS]). All items in the questionnaire were rated by the patient on a 5-point scale ranging from 0 (“not at all”) to 4 (“very much”). The total score ranged from 0 to 96. A higher score indicates better perceived quality of life. A positive change score from baseline indicates improvement. Symptom progression was defined as a decrease from baseline of 5 points or more.|Baseline to primary data cut-off on 13 May 2011 (up to 3 years, 3 months)|Intent-to-treat population: All randomized patients. Only female patients were included in the analysis.||Weeks||95% Confidence Interval|Median
753238|NCT00567190|Secondary|Duration of Objective Response Determined by an Independent Review Facility|Duration of objective response was defined as the time from the initial response to documented disease progression or death from any cause, whichever occurred first.|Baseline to primary data cut-off on 13 May 2011 (up to 3 years, 3 months)|Intent-to-treat population: All randomized patients. Only patients with an objective response were included in the analysis.||Weeks||95% Confidence Interval|Median
753239|NCT00567190|Secondary|Objective Response Determined by an Independent Review Facility|A patient had an objective response if they had a complete response or a partial response determined on two consecutive occasions ≥ 4 weeks apart as determined by the investigator using RECIST. For target lesions, a complete response was defined as the disappearance of all target lesions; a partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. For non-target lesions, a complete response was defined as the disappearance of all non-target lesions; a partial response was defined as the persistence of 1 or more non-target lesions.|Baseline to primary data cut-off on 13 May 2011 (up to 3 years, 3 months)|Intent-to-treat population: All randomized patients. Only patients with measurable disease at baseline were included in the analysis.||Percentage of patients||95% Confidence Interval|Number
753240|NCT00567190|Secondary|Progression-free Survival (PFS) Determined by the Investigator|PFS was defined as the time from randomization to first documented disease progression (PD) using Response Evaluation Criteria in Solid Tumors (RECIST) or death from any cause (within 18 weeks of last tumor assessment), whichever occurred first. For target lesions, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Target lesions were selected on the basis of their size (those with the longest diameter) and their suitability for accurate repeated measurements by imaging techniques or clinically. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, were identified as target lesions.|Baseline to the third data cut-off (11 February 2014) at 389 deaths (approximately 43 months after enrollment of the last patient, up to 6 years overall)|Intent-to-treat population: All randomized patients.||Months||95% Confidence Interval|Median
753241|NCT00567190|Secondary|Overall Survival|Overall survival was defined as the time from randomization to death from any cause. The median and 95 percent (%) confidence interval (CI) for time to event were estimated using Kaplan-Meier methodology.|Baseline to the third data cut-off (11 February 2014) at 389 deaths (approximately 43 months after enrollment of the last patient, up to 6 years overall)|Intent-to-treat population: All randomized patients.||Months||95% Confidence Interval|Median
753242|NCT00567190|Primary|Progression-free Survival (PFS) Determined by an Independent Review Facility|PFS was defined as the time from randomization to first documented disease progression (PD) using Response Evaluation Criteria in Solid Tumors (RECIST) or death from any cause (within 18 weeks of last tumor assessment), whichever occurred first. For target lesions, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Target lesions were selected on the basis of their size (those with the longest diameter) and their suitability for accurate repeated measurements by imaging techniques or clinically. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, were identified as target lesions.|Baseline to primary data cut-off on 13 May 2011 (up to 3 years, 3 months)|Intent-to-treat (ITT) population: All randomized patients.||Months||95% Confidence Interval|Median
753243|NCT00567229|Primary|Final Response Rate After 4 Courses of Treatment||2 years|||participants|||Number
753258|NCT00567255|Secondary|Change in IWQOL-Lite Total Scores|IWQOL-Lite= Impact of Weight on Quality of Life-Lite Questionnaire Total score is based on a scale from 0 to 100, with 0 representing the poorest and 100 the best quality of life and where a score of 71-79 indicates moderate impairment|Baseline, 28 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||units on a scale||Standard Error|Least Squares Mean
753259|NCT00567255|Secondary|Change in Fasting Triglycerides Levels, Using Log-transformed Data||Baseline, 28 weeks|||percent change||95% Confidence Interval|Least Squares Mean
753245|NCT00567242|Secondary|Picture Naming Probe Scores (% Accuracy)|Improvement for the time series from 8 baseline sessions through 30 treatment sessions for naming probes was computed with the C statistic using Tryon's (1982, 1983) formula for each subject. C statistics were converted to Z scores, using the formula provided by Tryon (1982). Z scores indicated treatment change for each subject, with a positive and significant Z score indicating substantive treatment gains. Z scores were then compared between groups with a t statistic. It was expected that the intention manipulation would lead to greater treatment gains than when it was not used.|trend for time series of 8 baseline + 30 treatment sessions|Data from all subjects completing their respective arms were analyzed, with the exception that one control subject was eliminated because of an unstable baseline measure.||Z score||Standard Deviation|Mean
753246|NCT00567242|Primary|Lateralization of Frontal Lobe (and Posterior Perisylvian) Activity During Word Production|Functional MRI laterality indices (LIs)were calculated for lateral frontal, medial frontal, and posterior perisylvian cortex regions of interest (ROIs): L=number of active voxels in left hemisphere ROI and R=number of active voxels in right hemisphere ROI using the following formula: (L-R)/(L+R). LIs could vary from -1 (completely right lateralized) to +1 (completely left lateralized). Then, change in LIs was calculated by subtracting the pre-treatment from the post-treatment and 3-mo follow-up LI. It was expected the intention manipulation would show a rightward shift in LI.|immediately post-treatment scan minus pre-treatment baseline scan|Data for all subjects completing the protocol for their respective arm were analyzed.||laterality index||Standard Deviation|Mean
753247|NCT00567255|Secondary|Change in Food Craving Inventory Carbohydrates Subscale Score|The Food Craving Inventory is a 33-item self-report measure designed to assess specific food cravings and is organized into 4 subscales (high fats, sweets, carbohydrates/starches, and fast-food fats). A craving was defined as an intense desire to consume a particular food (or food type) that was difficult to resist over the past month. Subjects rated their frequency of cravings for each of the 33 items using a 5-point scale, where 1=never, 2=rarely, 3=sometimes, 4=often, and 5=always. The carbohydrates subscale consisted of 8 items and the score ranges from 8 (better outcome) to 40 (worse outcome).|Baseline, 28 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||units on a scale||Standard Error|Least Squares Mean
753248|NCT00567255|Secondary|Change in Food Craving Inventory Sweets Subscale Score|The Food Craving Inventory is a 33-item self-report measure designed to assess specific food cravings and is organized into 4 subscales (high fats, sweets, carbohydrates/starches, and fast-food fats). A craving was defined as an intense desire to consume a particular food (or food type) that was difficult to resist over the past month. Subjects rated their frequency of cravings for each of the 33 items using a 5-point scale, where 1=never, 2=rarely, 3=sometimes, 4=often, and 5=always. The sweets subscale consisted of 8 items and the score ranges from 8 (better outcome) to 40 (worse outcome).|Baseline, 28 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||units on a scale||Standard Error|Least Squares Mean
753249|NCT00567255|Secondary|Change in IDS-SR Total Score|IDS-SR= Inventory of Depressive Symptoms-Subject Rated IDS-SR total score is based on 30 items. The total score can range from 0-84, with 0 being no depressive symptoms and 84 being very severe depressive symptoms. A total score ≤ 13 indicates no depression.|Baseline, 28 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||units on a scale||Standard Error|Least Squares Mean
753250|NCT00567255|Secondary|Change in Diastolic Blood Pressure||Baseline, 28 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||mm Hg||Standard Error|Least Squares Mean
753251|NCT00567255|Secondary|Change in Systolic Blood Pressure||Baseline, 28 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||mm Hg||Standard Error|Least Squares Mean
753252|NCT00567255|Secondary|Change in Fasting LDL Cholesterol Levels||Baseline, 28 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||mg/dL||Standard Error|Least Squares Mean
753253|NCT00567255|Secondary|Change in Question 19 From 21-Item COE (Control of Eating) Questionnaire|Question 19: Generally, how difficult has it been to control your eating? Scoring: 0=not at all difficult; 100=extremely difficult|Baseline, 28 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||units on a scale||Standard Error|Least Squares Mean
753254|NCT00567255|Secondary|Change in HOMA-IR Levels, Using Log-transformed Data|HOMA-IR= Homeostasis Model Assessment-Insulin Resistance|Baseline, 28 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||percent change||95% Confidence Interval|Least Squares Mean
753255|NCT00567255|Secondary|Change in Fasting Blood Glucose Levels||Baseline, 28 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||mg/dL||Standard Error|Least Squares Mean
753256|NCT00567255|Secondary|Change in Fasting Insulin Levels, Using Log-transformed Data||Baseline, 28 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||percent change||95% Confidence Interval|Least Squares Mean
753257|NCT00567255|Secondary|Change in High-sensitivity C Reactive Protein (Hs-CRP) Levels, Using Log-transformed Data||Baseline, 28 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||percent change||95% Confidence Interval|Least Squares Mean
769903|NCT00707655|Secondary|Tumor Response Rate/ Complete or Partial Response||2 years|||participants|||Number
753263|NCT00567255|Secondary|Body Weight- Proportion of Subjects With ≥5% Decrease From Baseline to Week 56|"Beginning at Week 28 through Week 44, NB32-treated subjects who failed to achieve or maintain at least 5% body weight loss from baseline were re-randomized (1:1 ratio) to continue NB32 or begin treatment with a higher dose of naltrexone SR - naltrexone SR 48 mg/bupropion SR 360 mg (referred to as NB48) (daily dose of bupropion SR was 360 mg for NB32 and NB48).The analysis of NB32 vs. placebo at Week 56 was completed using a weighted analysis. This analysis was referred to as the weighted LOCF analysis.
Subjects treated with NB32 who were re-randomized to NB48 were not included. Subjects re-randomized to NB32 were double-weighted and subjects who were not re-randomized were single-weighted. Subjects in the placebo group were single-weighted. The double weighting analysis restored the influence of poor performers at Weeks 28 to 44 in the NB32 group without including any data from the higher dose group (NB48)."|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||percentage of participants||95% Confidence Interval|Number
753264|NCT00567255|Primary|Co-primary: Body Weight- Proportion of Subjects With ≥5% Decrease From Baseline to Week 28||Baseline, 28 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||percentage of participants||95% Confidence Interval|Number
753265|NCT00567255|Secondary|Body Weight- Mean Percent Change From Baseline to Week 56|"Beginning at Week 28 through Week 44, NB32-treated subjects who failed to achieve or maintain at least 5% body weight loss from baseline were re-randomized (1:1 ratio) to continue NB32 or begin treatment with a higher dose of naltrexone SR - naltrexone SR 48 mg/bupropion SR 360 mg (referred to as NB48) (daily dose of bupropion SR was 360 mg for NB32 and NB48).The analysis of NB32 vs. placebo at Week 56 was completed using a weighted analysis. This analysis was referred to as the weighted LOCF analysis.
Subjects treated with NB32 who were re-randomized to NB48 were not included. Subjects re-randomized to NB32 were double-weighted and subjects who were not re-randomized were single-weighted. Subjects in the placebo group were single-weighted. The double weighting analysis restored the influence of poor performers at Weeks 28 to 44 in the NB32 group without including any data from the higher dose group (NB48)."|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||percentage of body weight||Standard Error|Least Squares Mean
753266|NCT00567255|Primary|Co-primary: Body Weight- Mean Percent Change From Baseline to Week 28||Baseline, 28 weeks|Modified ITT (Full Analysis Set): Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||percentage of body weight||Standard Error|Least Squares Mean
753267|NCT00567268|Other Pre-specified|Number of Participants Who Responded to Treatment With Gabapentin by Presence or Absence of Non-Drug Therapy|Participants who responded to the treatment with gabapentin were counted by the presence or absence of non-drug therapy to assess whether the non-drug therapy was a factor affecting the treatment efficacy.|12 weeks|The efficacy analysis population comprised of the participants who had at least one post-baseline efficacy evaluation for the clinical efficacy and seizure frequency in the safety analysis population. Participants who had diseases not eligible for the survey were excluded from the efficacy analysis population.||participants|||Number
753268|NCT00567268|Other Pre-specified|Number of Participants Who Responded to Treatment With Gabapentin by Baseline Creatinine Clearance|Participants who responded to the treatment with gabapentin were counted by the baseline creatinine clearance (CLcr) across 6 categories to assess whether the baseline CLcr was a factor affecting the treatment efficacy.|12 weeks|The efficacy analysis population comprised of the participants who had at least one post-baseline efficacy evaluation for the clinical efficacy and seizure frequency in the safety analysis population. Participants who had diseases not eligible for the survey were excluded from the efficacy analysis population.||participants|||Number
753269|NCT00567268|Other Pre-specified|Number of Participants Who Responded to Treatment With Gabapentin by Number of Concomitant Antiepileptic Drugs at Baseline|Participants who responded to the treatment with gabapentin were counted by the number of concomitant epileptic drugs at baseline across 5 categories to assess whether the number of concomitant epileptic drugs at baseline was a factor affecting the treatment efficacy.|12 weeks|The efficacy analysis population comprised of the participants who had at least one post-baseline efficacy evaluation for the clinical efficacy and seizure frequency in the safety analysis population. Participants who had diseases not eligible for the survey were excluded from the efficacy analysis population.||participants|||Number
753270|NCT00567268|Other Pre-specified|Number of Participants Who Responded to Treatment With Gabapentin by Baseline Frequency of Epileptic Seizure|Participants who responded to the treatment with gabapentin were counted by the baseline frequency of epileptic seizure (<=8 vs. >8 episodes) to assess whether the baseline frequency of epileptic seizure was a factor affecting the treatment efficacy.|12 weeks|The efficacy analysis population comprised of the participants who had at least one post-baseline efficacy evaluation for the clinical efficacy and seizure frequency in the safety analysis population. Participants who had diseases not eligible for the survey were excluded from the efficacy analysis population.||participants|||Number
753271|NCT00567268|Other Pre-specified|Number of Participants Who Responded to Treatment With Gabapentin by Severity of Partial Epileptic Seizure|Participants who responded to the treatment with gabapentin were counted by the severity of partial epileptic seizure (mild, moderate and severe) to assess whether the severity of partial epileptic seizure was a factor affecting the treatment efficacy.|12 weeks|The efficacy analysis population comprised of the participants who had at least one post-baseline efficacy evaluation for the clinical efficacy and seizure frequency in the safety analysis population. Participants who who had diseases not eligible for the survey were excluded from the efficacy analysis population.||participants|||Number
753272|NCT00567268|Other Pre-specified|Number of Participants Who Responded to Treatment With Gabapentin by Age Across 7 Categories|Participants who responded to the treatment with gabapentin were counted by age across 7 categories to assess whether the age was a factor affecting the treatment efficacy.|12 weeks|The efficacy analysis population comprised of the participants who had at least one post-baseline efficacy evaluation for the clinical efficacy and seizure frequency in the safety analysis population. Participants who had diseases not eligible for the survey were excluded from the efficacy analysis population.||participants|||Number
753274|NCT00567268|Other Pre-specified|Number of Participants With Treatment-Related Adverse Events by Number of Concomitant Antiepileptic Drugs at Baseline|A treatment-related adverse event was any untoward medical occurrence attributed to gabapentin in a participant who received gabapentin. Participants with treatment-related adverse events were counted by the number of concomitant antiepileptic drugs at baseline across 5 categories to assess whether the number of concomitant antiepileptic drugs at baseline was a risk factor for the treatment-related adverse events.|12 weeks|The safety analysis population comprised of participants who had met the inclusion criteria and had taken gabapentin at least once.||participants|||Number
753275|NCT00567268|Other Pre-specified|Number of Participants With Treatment-Related Adverse Events by Age Across 7 Categories|A treatment-related adverse event was any untoward medical occurrence attributed to gabapentin in a participant who received gabapentin. Participants with treatment-related adverse events were counted by age across 7 categories to assess whether the age was a risk factor for the treatment-related adverse events.|12 weeks|The safety analysis population comprised of participants who had met the inclusion criteria and had taken gabapentin at least once.||participants|||Number
753276|NCT00567268|Secondary|Percent Reduction From Baseline in Epileptic Seizure Frequency|Percent reduction from the baseline in epileptic seizure frequency, was calculated by the following formula, where B represented the frequency of epileptic seizures during 4 weeks before gabapentin treatment, whereas T represented the frequency of epileptic seizures during 4 weeks at the end of observation period of gabapentin treatment: Reduction from the baseline in epileptic seizure frequency (%) = [(T-B)/B] X 100.|12 weeks|The analysis population comprised of the participants whose frequency of epileptic seizures during 4 weeks before gabapentin treatment (represented by B) was at least once within the R ratio analysis population.||Percentage||Standard Deviation|Mean
753277|NCT00567268|Secondary|Responder Rate|Responder rate, which was defined as the percentage of participants whose R ratio was -0.333 or less, was presented along with the corresponding exact 2-sided 95% CI. R ratio of -0.333 or less corresponded to the decrease of epileptic seizure frequency by 50% or more.|12 weeks|Responder rate analysis population comprised of the participants who calculated R ratio at the start of gabapentin treatment and at the end of monitoring period in the efficacy analysis population.||Percentage of participants||95% Confidence Interval|Number
753278|NCT00567268|Secondary|Response Ratio (R Ratio)|Response Ratio (R Ratio) was calculated by the following formula, where B represented the frequency of epileptic seizures during 4 weeks before gabapentin treatment, whereas T represented the frequency of epileptic seizures during 4 weeks at the end of observation period of gabapentin treatment: R Ratio= (T-B) / (T+B). R Ratio was within the range of -1 to +1, and a negative value represented a reduction in the frequency of seizure.|12 weeks|R ratio analysis population comprised of the participants who calculated R ratio at the start of gabapentin treatment and at the end of monitoring period in the efficacy analysis population.||Ratio||Standard Deviation|Mean
753279|NCT00567268|Primary|Clinical Efficacy Rate|Clinical efficacy rate, which was defined as the percentage of participants who achieved clinical efficacy over the total number of efficacy analysis population, was presented along with the corresponding exact 2-sided 95% CI. For the basis of efficacy evaluation, frequencies of epileptic seizure were recorded for the periods during the previous 4 weeks from the treatment start date, and that from the end date of observation (12 weeks after the treatment start date, or date of which treatment was terminated before reaching 12 weeks). Clinical efficacy was assessed according to the following categories: (1) effective, (2) not effective, or (3) not assessable.|12 weeks|The efficacy analysis population comprised of the participants who had at least one post-baseline efficacy evaluation for the clinical efficacy and seizure frequency within the safety analysis population. Participants who had disease not eligible for the survey were excluded from the efficacy analysis population.||Percentage of participants||95% Confidence Interval|Number
753280|NCT00567268|Primary|Number of Participants With Treatment-Related Adverse Events|A treatment-related adverse event was any untoward medical occurrence attributed to gabapentin in a participant who received gabapentin. Relatedness to gabapentin was assessed by the sponsor (Pfizer Japan Inc.).|12 weeks|The safety analysis population comprised of participants who had met the inclusion criteria and had taken gabapentin at least once.||participants|||Number
753281|NCT00567268|Primary|Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert|A treatment-related adverse event was any untoward medical occurrence attributed to gabapentin in a participant who received gabapentin. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to gabapentin was assessed by the sponsor (Pfizer Japan Inc.).|12 weeks|The safety analysis population comprised of participants who had met the inclusion criteria and had taken gabapentin at least once.||participants|||Number
753282|NCT00567307|Primary|Reduction of the Estimated 10-year Total Cardiovascular Risk Score|Estimated 10-year CVD total risk score were calculated in the field centers and in the Coordinating Center from the measures of blood pressure and total cholesterol and from the medical history data collected during each visit using the WHO CVD prediction chart. The estimated 10-year CVD total risk calculated by the Coordinating Center were used for analysis. the score is based on systolic blood pressure and total cholesterol measures as well as on medical history data (monthly). Each one of these risk factors is assigned a point in the score and then linked to a table that mention the calculated CVD risk|Six months|||percent||Standard Deviation|Mean
753283|NCT00567320|Primary|Proportion of Cocaine Positive Urine Tests Per Week|Urine samples were obtained thrice-weekly and analyzed for the presence of cocaine metabolites. Levels that exceeded 300 ng / ml on each individual urine test were considered positive. The primary outcome measure was the proportions of positive cocaine urine results per week that was calculated by using the total number of completed tests as the denominator and the total number of positive tests for that week as the numerator. This data was subjected to Hierarchical Linear Modeling (HLM) analysis using a total of 13 longitudinal results that included a baseline result (Week 0).|Weekly Measures over 12 weeks|Intention to treat analysis of all subjects receiving medication||Proportion of cocaine positive||Standard Deviation|Mean
753305|NCT00567567|Secondary|Response Rate|A chi-square test of association will be used to compare the proportion of responders with versus without a polymorphism.|42 days||||||
753306|NCT00567567|Secondary|Proportion of Patients With Neuroblastoma Detected in Bone Marrow and Peripheral Blood Using RT-PCR Technique|Will be calculated overall and by treatment arm.|Baseline||||||
753284|NCT00567476|Secondary|Patient's Global Assessment of Treatment Effectiveness|"At the end of Week 20, a global evaluation of the treatment effectiveness was performed by the patient using the following scale:
Excellent: complete control of asthma; Good: marked improvement of asthma; Moderate: discernible, but limited improvement in asthma; Poor: no appreciable change in asthma; Worsening of asthma"|20 Weeks|All randomized patients who took at least one dose of double-blind study medication and who had at least one post-baseline safety or efficacy assessment made up the ITT population.||Participants|||Number
753285|NCT00567476|Secondary|Physician's Global Assessment of Treatment Effectiveness|At the end of Week 20 a global evaluation of the treatment effectiveness was performed by the investigator using the following scale: Excellent: complete control of asthma; Good: marked improvement of asthma; Moderate: discernible, but limited improvement in asthma; Poor: no appreciable change in asthma; Worsening of asthma|20 Weeks|All randomized patients who took at least one dose of double-blind study medication and who had at least one post-baseline safety or efficacy assessment made up the intention-to-treat (ITT) population.||Participants|||Number
753286|NCT00567476|Secondary|Mean Number of Puffs of Rescue Medication Taken Per Day|When necessary, patients were allowed to take rescue medication using inhaled salbutamol or terbutaline for symptoms of intercurrent bronchospasm. The number of puffs taken during each 24 hour period was recorded in the patient dairy. The total number of puffs over 20 weeks of treatment was divided by the number of treatment days (140 days) to calculate the mean number of puffs per day.|From Baseline through 20 Weeks|All randomized patients who took at least one dose of double-blind study medication and who had at least one post-baseline safety or efficacy assessment made up the intention-to-treat (ITT) population. Number of patients analyzed includes only those patients requiring rescue medication during the study.||Puffs||Standard Deviation|Mean
753287|NCT00567476|Secondary|Free Days With no Rescue Medication|When necessary, patients were allowed to take rescue medication using inhaled salbutamol or terbutaline for symptoms of intercurrent bronchospasm. Days with no rescue medication intake were the variable of interest for this analysis.|From Baseline through 20 weeks (140 days)|All randomized patients who took at least one dose of double-blind study medication and who had at least one post-baseline safety or efficacy assessment made up the intention-to-treat (ITT) population.||Days||Standard Deviation|Mean
753288|NCT00567476|Secondary|Percentage of Participants Using Rescue Medication|When necessary, patients were allowed to take rescue medication using inhaled salbutamol or terbutaline for symptoms of intercurrent bronchospasm.|From Baseline through 20 Weeks|All randomized patients who took at least one dose of double-blind study medication and who had at least one post-baseline safety or efficacy assessment made up the intention-to-treat (ITT) population.||Percentage of participants||95% Confidence Interval|Number
753289|NCT00567476|Secondary|Number of Asthma Exacerbation Episodes Per Participant|For the purpose of evaluating efficacy, a clinically significant asthma exacerbation was defined as a worsening of asthma symptoms as judged clinically by the investigator, requiring doubling the baseline ICS dose for at least 3 days and/or treatment with rescue systemic (oral or IV) corticosteroids. The initiation of the above corticosteroid regimens marked the start of an asthma exacerbation episode and cessation of the additional corticosteroid regimens marked the end of an exacerbation episode.|From Baseline through 20 weeks|All randomized patients who took at least one dose of double-blind study medication and who had at least one post-baseline safety or efficacy assessment made up the ITT population.||Participants|||Number
753290|NCT00567476|Secondary|The Mean Change From Baseline to the End of Study in AQLQ Domain Score|"AQLQ was administered to all patients at Baseline, Week 12 and Week 20, and prior to any clinic visit evaluation and drug administration.
The 32 questions in the AQLQ were divided into four domains: activity limitations, symptoms, emotional function, and environmental stimuli. AQLQ domain scores were calculated by adding the responses to each of the questions in the domain and dividing by the number of questions in the domain. Each domain score was between 1 and 7. Score 7.0 meant that the patient had no impairments due to asthma and score 1.0 indicated severe impairment."|Baseline and Week 20|Patients who took at least one dose of double-blind study drug and who had at least one post-baseline safety or efficacy assessment made up the intent-to treat (ITT) population. Last observation carried forward (LOCF) approach was used. Scores of completed AQLQ at Week 12 were used at Week 20 for dropped out patients or for missing values.||Units on a scale||Standard Error|Mean
753291|NCT00567476|Primary|The Mean Change From Baseline to Week 20 in the Overall Asthma Quality of Life Questionnaire (AQLQ)|The AQLQ was administered to all patients at Baseline, Week 12 and Week 20. The 32 questions in the AQLQ were divided into four domains; activity limitations, symptoms, emotional function, and environmental stimuli. Individual questions are equally weighted. The overall AQLQ score is the mean of the responses to each of the 32 questions, and ranges from 1 to 7. A score 7.0 indicates that the patient has no impairments due to asthma and a score of 1.0 indicates severe impairment.|Baseline and Week 20|Patients who took at least one dose of double-blind study drug and who had at least one post-baseline safety or efficacy assessment made up the intent-to treat (ITT) population. Last observation carried forward (LOCF) approach was used. Scores of completed AQLQ at Week 12 were used at Week 20 for dropped out patients or for missing values.||Units on a scale||Standard Error|Mean
753292|NCT00567476|Secondary|Percentage of Participants With an Increase of More Than 0.5 in AQLQ Overall Score at Week 20|The AQLQ was administered to all patients at Baseline, Week 12 and Week 20. The 32 questions in the AQLQ were divided into four domains; activity limitations, symptoms, emotional function, and environmental stimuli. Individual questions are equally weighted. The overall AQLQ score is the mean of the responses to each of the 32 questions and ranges from 1 to 7. AQLQ of each domain is the mean of the responses to each of the questions within that domain. A score 7.0 indicates that the patient has no impairments due to asthma and score 1.0 indicates severe impairment.|Baseline and Week 20|Patients who took at least one dose of double-blind study drug and who had at least one post-baseline safety or efficacy assessment made up the intent-to treat (ITT) population. Last observation carried forward (LOCF) approach was used. Scores of completed AQLQ at Week 12 were used at Week 20 for dropped out patients or for missing values.||Percentage of participants||95% Confidence Interval|Number
753307|NCT00567567|Secondary|Presence and Function of T Cells Capable of Recognizing Neuroblastoma||Up to 6 months (end of therapy)|The data was not collected to assess this study aim.|||||
755310|NCT00593606|Primary|Change in Creatinine|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||mg/dl||Standard Deviation|Mean
753293|NCT00567476|Secondary|Percentage of Participants With an Increase of More Than 1.5 in AQLQ Overall Score at 20 Weeks|The AQLQ was administered to all patients at Baseline, Week 12 and Week 20. The 32 questions in the AQLQ were divided into four domains; activity limitations, symptoms, emotional function, and environmental stimuli. Individual questions are equally weighted. The overall AQLQ score is the mean of the responses to each of the 32 questions and ranges from 1 to 7. A score 7.0 indicates that the patient has no impairments due to asthma and score 1.0 indicates severe impairment.|Baseline and Week 20|Patients who took at least one dose of double-blind study drug and who had at least one post-baseline safety or efficacy assessment made up the intent-to treat (ITT) population. Last observation carried forward (LOCF) approach was used. Scores of completed AQLQ at Week 12 were used at Week 20 for dropped out patients or for missing values.||Percentage of participants||95% Confidence Interval|Number
753294|NCT00567502|Primary|Number of Participants With Suspected Serious Adverse Reaction (SSAR) Events|SSAR: serious adverse event (SAE) that was considered related to cytoreductive therapy. SAE: any untoward medical occurrence that at any dose resulted in death, life-threatening (at the time of the event), in-patient hospitalization/prolongation of existing hospitalization (elective hospitalizations/procedures for pre-existing conditions that had not worsened were excluded), resulted in persistent or significant disability/incapacity or congenital abnormality/birth defect. Relatedness (suspected/not suspected) to XAGRID or other cytoreductive theraphy was determined by the investigator. As for SSARs, it was important to consider whether the events were related to XAGRID or other cytoreductive therapy. A participant was included in Xagrid or other treatment group based on treatment exposure, participants received Xagrid + Other was counted both in Xagrid and other treatment group.|Up to 5 years|"Overall treatment safety population. All events/data were allocated to the treatment that a participant was receiving at the time of the event/assessment. Participants who had exposed to XAGRID (alone or in combination with other) was counted in Xagrid arm and those who had received other ET therapy in the Other (Cytoreductives)."||participants|||Number
753295|NCT00567502|Secondary|Cumulative Dose for Each Essential Thrombocythemia (ET) Therapy|Since the study is observational nature, interpreting the table is difficult due to inconsistencies in reporting the units of the dose.|Up to 5 years|Overall Treatment Safety Population. As participant could switch between therapies a participant with an event could be allocated to more than one therapy group. Participants analyzed included who were exposed to the specific treatment any time during the study.||milligram (mg)||Standard Deviation|Mean
753296|NCT00567502|Secondary|Duration of Exposure for Each Essential Thrombocythemia (ET) Therapy|Total duration for each participant = sum of [stop date - start date + 1] across all periods of time where the specific treatment was taken during the study, where start date = registration/consent date for treatments started before registration/consent date and/or stop date withdrawal/final date for treatments ongoing at the time of withdrawal/end of study. Where a participant has multiple records of the same therapy on the same day, the therapy is counted once for that day.|Up to 5 years|Overall Treatment Safety Population. As participant could switch between therapies a participant with an event could be allocated to more than one therapy group. Participants analyzed included who were exposed to the specific treatment any time during the study.||days||Standard Deviation|Mean
753297|NCT00567502|Secondary|Platelet Count||Baseline, Month 6,12,18, 24, 30, 36, 42, 48, 54, 60|Overall Treatment Safety population, Here n = participants evaluable at specified time-points. As participant could switch between therapies a participant with an event could be allocated to more than one therapy group. Participants analyzed included who were exposed to the specific treatment any time during the study.||10^9 per Liter (10^9/L)||Standard Deviation|Mean
753298|NCT00567502|Secondary|Event Rate of Thrombohaemorrhagic Events|Event Rate of Thrombohaemorrhagic Events was calculated by dividing number of participants with events by total patient-year exposure. The reporting unit is per 100 participant-years of treatment exposure. Thrombohaemorrhagic Events is a composite endpoint of the PDEs myocardial infarction, angina, stroke, transient ischaemic attack, venous thromboembolic events, intermittent claudication/digital ischaemia, and major haemorrhagic events.|Up to 5 years|Overall Treatment Safety Population. As participant could switch between therapies a participant with an event could be allocated to more than one therapy group. Participants analyzed included who were exposed to the specific treatment any time during the study.||participants/100 participant-years|||Number
753299|NCT00567502|Primary|Percentage of Participants With At Least One Pre-Defined Event (PDE), Deaths, Pregnancies|Pre-defined events (PDEs) were evaluated whenever an event occurred and was defined by a panel of independent qualified physicians, blinded to cytoreductive therapy, validated all PDEs prior to analysis (Event Validation Panel). Non-PDE death only included deaths not recorded as outcome of another PDE.|Up to 5 years|First Treatment Safety Population included participants who received cytoreductive therapy at registration. All events/data were allocated to the treatment that a participant was receiving at the time of the event/assessment.||percentage of participants|||Number
753300|NCT00567541|Primary|Relief of Chronic Shoulder Pain|Brief Pain Inventory (BPI) Question # 12 (rating pain at its worst in week prior to visit) was used to measure number of participants in whom BBPM provided any relief from chronic shoulder pain after implantation, as evidence by appropriate muscular contraction and/or paresthesia. BPI scale range is from 1 to 10, where 0 = 'no pain' and 10 = 'pain as bad as one can imagine'.|From baseline to 48 week follow up|Intent to Treat population was analyzed||participants|||Number
753301|NCT00567567|Secondary|Type of Surgical Complication|The proportion of patients by type of surgical complication and type of radiation therapy complication will be descriptively tabulated. The complications are: bowel obstruction, chylous leak, renal injury/atrophy/loss and diarrhea.|Up to 3 years||||||
753302|NCT00567567|Secondary|Type of Radiotherapy Complication|The proportion of patients by type of surgical complication and type of radiation therapy complication will be descriptively tabulated. The complications are: bowel obstruction, chylous leak, renal injury/atrophy/loss and diarrhea.|Up to 3 years||||||
753303|NCT00567567|Secondary|Topotecan Systemic Clearance|Median topotecan systemic clearance for courses 1 and 2.|Day 1 of courses 1-2|Eligible patients evaluated for topotecan systemic clearance.||L/h/m2||Full Range|Median
753304|NCT00567567|Secondary|Surgical Response|A chi-square test of proportions will be used to test for association between the proportion of patients who achieve a surgical CR and the proportion of patients who do not relapse in the primary. A logrank test will compare the EFS curves for degree of surgical response (CR vs. < CR).|Up to 3 years||||||
753308|NCT00567567|Secondary|Pharmacogenetic Variants in Patients Enrolled on Either A3973, ANBL0032, ANBL0931, ANBL0532 and Future High Risk Studies|To determine if pharmacogenomic variations are predictive of EFS, a logrank test comparison of patients with vs without a given polymorphism will be made. A Fisher’s exact test will test for association of the presence of a polymorphism with the occurrence of systemic toxicity (CTC grade 3 or 4 skin, hypercalcemia, or hepatic toxicity). These tests will be performed for UGT1A1, UGT2B7, CYP2C8 and CYP3A7 alleles.|Baseline||||||
753309|NCT00567567|Secondary|Peak Serum Concentration of Isotretinoin in Patients Enrolled on Either A3973, ANBL0032, ANBL0931, ANBL0532 and Future High Risk Studies|Median peak serum concentration level of isotretinoin for patients enrolled on ANBL0532|Day 1 of each course|Eligible patients evaluated for peak serum concentration level of isotretinoin.||Micromolar||Full Range|Median
753310|NCT00567567|Secondary|OS in Patients 12-18 Months, Stage 4, MYCN Nonamplified Tumor/Unfavorable Histopathology/Diploid DNA Content/Indeterminant Histology/Ploidy and Patients > 547 Days, Stage 3, MYCN Nonamplified Tumor AND Unfavorable Histopathology/Indeterminant Histology|Kaplan-Meier curves of OS will be plotted, and the proportion of responders to induction therapy will be tabulated.|Up to 3 years|||percent probability||95% Confidence Interval|Number
753311|NCT00567567|Secondary|Neurologic Symptom Resolution in Patients With Primary Tumors With Intraspinal Extension|Descriptive tabulation of the proportion of patients with resolution of neurologic symptoms by type of symptom.|Up to 5 years||||||
753312|NCT00567567|Secondary|Enumeration of Peripheral Blood Cluster of Differentiation (CD)3, CD4, and CD8 Cells|A descriptive comparison of the median number of T-cells (CD3, CD4, CD8) between treatment arms (single vs. tandem myeloablative regimens) will be performed.|Up to 6 months after completion of assigned myeloablation therapy|All eligible patients that had CD3, CD4 and CD8T-cell count evaluated at the end of reporting period 3.||cells/mm^3||Full Range|Median
753313|NCT00567567|Secondary|EFS Pts Non-randomly Assigned to Single CEM (12-18 Mths, Stg. 4, MYCN Nonamplified Tumor/Unfavorable or Indeterminant Histopathology/Diploid DNA Content & Pts>547 Days, Stg.3, MYCN Nonamplified Tumor AND Unfavorable or Indeterminant Histopathology).|Kaplan-Meier curves of EFS will be plotted, and the proportion of responders to induction therapy will be tabulated.|Up to 3 years|All eligible patients non-randomly assigned to single CEM||percent probability||95% Confidence Interval|Number
753314|NCT00567567|Secondary|Duration of Greater Than or Equal to Grade 3 Thrombocytopenia|A logistic regression model will be used to test the ability of the number of days of thrombocytopenia to predict the presence of a polymorphism.|21 days||||||
753315|NCT00567567|Secondary|Duration of Greater Than or Equal to Grade 3 Neutropenia|A logistic regression model will be used to test the ability of the number of days of neutropenia to predict the presence of a polymorphism.|21 days||||||
753316|NCT00567567|Primary|Response After Induction Therapy|Per the International Response Criteria: measurable tumor defined as product of longest x widest perpendicular diameter. Elevated catecholamine levels, tumor cell invasion of bone marrow also considered measurable tumor. Complete Response (CR)-no evidence of primary tumor or metastases. Very Good Partial Response (VGPR)->90% reduction of primary tumor; no metastases; no new bone lesions, all pre-existing lesions improved. Partial Response (PR)-50-90% reduction of primary tumor; >50% reduction in measurable sites of metastases; 0-1 bone marrow samples with tumor; number of positive bone sites decreased by >50%. Mixed Response (MR)->50% reduction of any measurable lesion (primary or metastases) with <50% reduction in other sites; no new lesions; <25% increase in any existing lesion. No Response (NR)-no new lesions; <50% reduction but <25% increase in any existing legions. Progressive Disease (PD)-any new/increased measurable lesion by >25%; previous negative marrow positive.|Study enrollment to the end of induction therapy|Eligible patients evaluated for response at the end of induction therapy.||Proportion participants that responded||95% Confidence Interval|Number
753317|NCT00567567|Primary|Incidence Rate of Local Recurrence|Cumulative incidence rate of local recurrence comparison between ANBL0532 patients randomized or assigned to receive single CEM transplant and boost radiation versus the historical A3973 patients who were transplanted and received boost radiation.|Up to 3 years|Eligible patients randomized or assigned to the single HST (CEM) treatment arm who also received boost radiation.||Percentage 3-year cumulative incidence||95% Confidence Interval|Number
753318|NCT00567567|Primary|Event-free Survival Rate|Comparison of EFS curves, starting from the time of randomization, by treatment group (single CEM vs. tandem CEM)|Three years, from time of randomization|All eligible, randomized patients.||percent probability||95% Confidence Interval|Number
753319|NCT00567593|Primary|PDK4 mRNA||14 days|||copies/nL||Full Range|Median
753320|NCT00573755|Secondary|Adverse Event|Number of participants that experienced adverse events (grade 3 and above) as measured by NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Adverse events were assessed every week during first 6 weeks of therapy, every 4 weeks on months 1 to 6, every 12 weeks on months 7 and beyond and at the end of treatment.|Time from randomization to end of treatment|||participants|||Number
753321|NCT00573755|Secondary|Duration of Response|Duration of response was defined for all patients who have achieved a confirmed response as the date at which the patient's earliest best objective status was first noted to be either a CR or PR to the earliest date progression was documented.|Up to 5 years|The number of patients enrolled in the study does not allow for meaningful analysis for this outcome.|||||
753322|NCT00573755|Secondary|Objective Tumor Response Rate|A confirm response was defined as either a complete response (CR) or partial response (PR) noted as the objective status on 2 consecutive evaluation at least 4 weeks apart. The confirmed response rate was estimated within each treatment group by the number of confirmed responses divided by the total number of participants randomized.|Up to 5 years|The number of patients enrolled in the study does not allow for meaningful analysis for this outcome.|||||
753323|NCT00573755|Secondary|Time to Treatment Failure|Time to treatment failure was defined as the time from the date of the randomization to the date at which the patient was removed from treatment due to progression, adverse events, or refusal.|Time from randomization to treatment failure (up to 5 years)|The number of patients enrolled in the study does not allow for meaningful analysis for this outcome.|||||
753324|NCT00573755|Secondary|Overall Survival|Survival time was defined as the time from randomization to death due to any cause.|Time from randomization to death (up to 5 years)|The number of patients enrolled in the study does not allow for meaningful analysis for this outcome. All patients were alive at the time of their last treatment follow up.|||||
753325|NCT00573755|Primary|Progression-free Survival|Progression-free survival was defined as the time from randomization to the earliest date of documentation of disease progression or death due to any cause. In the case of a participant started treatment and then never return for any evaluations, the participant was censored for progression 1 day post-randomization.|Time from randomization to disease progression or death (up to 5 years)|All participants who have met the eligibility criteria, signed a consent form and were randomized to one of the two treatment groups were evaluable for the primary endpoint.||months||95% Confidence Interval|Median
753326|NCT00573768|Primary|Pain on Movement on Day 5 (Change From Baseline). A Greater Change From Baseline on Day 5 Equates to a Better Outcome.|Pain on movement: visual analogue scale (VAS) with anchors at 0 mm (no pain) and 100 mm (extreme pain)|change from baseline (on day 1) to day 5|Intent to treat (ITT)||mm||Standard Deviation|Mean
753327|NCT00573859|Secondary|The Interacting Effects of Smoking and Abstinence With ADHD Medication and Placebo on Nicotine Withdrawal Measured by the Shiffman-Jarvik Withdrawal Questionnaire.|The Shiffman-Jarvik withdrawal questionnaire measures nicotine withdrawal and was completed after each CPT assessment. The questionnaire consists of 25 items using 8-point scales. Total scores range from 0 to 200 and higher scores reflect higher levels of nicotine withdrawal.|4 days|||scores on a scale||Full Range|Median
753328|NCT00573859|Secondary|The Interacting Effects of Smoking and Overnight Abstinence With ADHD Medication and Placebo on Continuous Performance Task (CPT) Errors of Omission.|In the morning of each monitoring day, approximately 60 minutes after medication or placebo pill administration, participants were asked to either abstain from smoking or smoke their first cigarette of the day 5 minutes prior to starting the CPT.|4 days|||errors||Standard Error|Mean
753329|NCT00573859|Primary|The Effects of ADHD Medication Versus Placebo on Cotinine Levels|Salivary cotinine was measured across two days on ADHD medication versus two days on placebo.|4 days|Smokers with ADHD||ng/ml||Standard Error|Mean
753330|NCT00573937|Secondary|Change in Numeric Pain Scale Score|Subjects will be verbally questioned about their pain on a scale from 0 to 10, with 0 being symptoms are absent to 10, the worst possible pain.|48 hours|Due to slow accrual, the study was terminated and no data were analyzed.|||||
753331|NCT00573937|Primary|Change in Numeric Pain Scale Score|Subjects will be verbally questioned about their pain on a scale from 0 to 10, with 0 being symptoms are absent to 10, the worst possible pain. Response to treatment is defined as a 33% reduction in pain score from the baseline to the Week 4 pain score.|Baseline, Week 4|Due to slow accrual, the study was terminated and no data were analyzed.|||||
753332|NCT00575367|Primary|Concentration of AzaSite and Vigamox in the Tear Fluid Across Six Time Points Ranging From 15 Minutes to 24 Hours Following Administration.||15 minutes, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours|Per Protocol Population||µg/mL||Standard Deviation|Mean
753333|NCT00575380|Secondary|Aqueous Humor Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population)||Az(hr): 1,12,48,49,72,144,145,168,216,312; Vig(hr): 1,8,48,49,56,144,145,168,216,312|||ug/mL||Standard Deviation|Mean
753334|NCT00575380|Primary|Conjunctiva Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population)|Nominal time is scheduled time relative to administration of the first eye drop|Az(hr): 1,12,48,49,72,144,145,168,216,312; Vig(hr): 1,8,48,49,56,144,145,168,216,312|||ug/g||Standard Deviation|Mean
753335|NCT00575510|Secondary|State Trait Anxiety Inventory (STAI)-State Scale|State Anxiety short form measure (6-item); higher scores =worse outcomes (i.e., higher self-reported anxiety levels)|+ 7-30 days post-intervention|Only participants who completed the post-test over the telephone 7-14 following notification of the abnormal Pap test result were asked these questions.||units on a scale, possible range 6-24||Standard Deviation|Mean
753336|NCT00575510|Primary|Adherence to Initial Follow-up (Yes/no)|Attendance at initial appointment to follow-up abnormal Pap test result|adherence rates at initial follow-up appointment, 2 weeks to 3 months|||percentage of patients who were adherent|||Number
753337|NCT00575588|Other Pre-specified|Mean Slope of the Regressions of Change From Week 24 to Week 104 in HbA1c|Mean slopes of regression of change from Week 24 to Week 104 in HbA1c for saxagliptin added on to metformin versus glipizide added on to metformin (Full Analysis Set) achieved by fitting a mixed model with subject specific slopes for the time effect (weeks on randomized treatment was utilized). This analysis gives an assessment of the durability of the HbA1c effect.|Week 24 to Week 104|||Percent||Standard Error|Mean
753338|NCT00575588|Other Pre-specified|Body Weight Change From Baseline to Week 104|Adjusted mean change from baseline in Body Weight achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 104. Body Weight is a continuous measure, the change from baseline for each participant is calculated as the Week 104 value minus the baseline value.|Baseline, Week 104|Number of subjects with observed values at Week 104 was n=186 for saxagliptin + metformin and n=165 for glipizide + metformin||kilograms||Standard Error|Mean
753339|NCT00575588|Other Pre-specified|Proportion of Participants Reporting at Least One Episode of Any Hypoglycaemic Event Over 104 Weeks|Proportion of participants reporting at least one episode of any hypoglycaemic event for saxagliptin added on to metformin versus glipizide added on to metformin over 104 weeks (Safety Analysis Set)|Baseline, Week 104|||Percentage of Participants|||Number
753340|NCT00575588|Other Pre-specified|Hemoglobin A1c (HbA1c) Change From Baseline to Week 104|Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 104 (Full Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 104 value minus the baseline value.|Baseline, Week 104|Number of subjects with observed values at Week 104 was n=184 for saxagliptin + metformin and n=160 for glipizide + metformin||Percent||Standard Error|Mean
753341|NCT00575588|Secondary|Mean Slope of the Regressions of Change From Week 24 to Week 52 in HbA1c|Mean slopes of regression of change from Week 24 to Week 52 in HbA1c for saxagliptin added on to metformin versus glipizide added on to metformin (Per Protocol Analysis Set) achieved by fitting a mixed model with subject specific slopes for the time effect (weeks on randomized treatment was utilized). This analysis gives an assessment of the durability of the HbA1c effect.|Week 24 to Week 52|Randomized participants who completed the 52 weeks of treatment had both baseline and week 52 HbA1c measurement and had no significant protocol deviations||Percent||Standard Error|Mean
755311|NCT00593606|Primary|Change in Chloride|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||mmol/l||Standard Deviation|Mean
753342|NCT00575588|Secondary|Body Weight Change From Baseline to Week 52|Adjusted mean change from baseline in Body Weight achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 52 (Safety Analysis Set). Body Weight is a continuous measure, the change from baseline for each participant is calculated as the Week 52 (LOCF) value minus the baseline value.|Baseline, Week 52 (Last Observation Carried Forward)|Randomized participants who took at least 1 dose of double-blind treatment. To be included in the LOCF analysis, participants must have had a baseline and at least 1 post-baseline measurement||kilogram||Standard Error|Mean
753343|NCT00575588|Secondary|Proportion of Participants Reporting at Least One Episode of Any Hypoglycaemic Event Over 52 Weeks|Proportion of participants reporting at least one episode of any hypoglycaemic event for saxagliptin added on to metformin versus glipizide added on to metformin over 52 weeks (Safety Analysis Set)|From Baseline to Week 52|||Percentage of Participants|||Number
753344|NCT00575588|Primary|Hemoglobin A1c (HbA1c) Change From Baseline to Week 52|Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 52 (Per Protocol Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 52 value minus the baseline value.|Baseline to 52 Weeks|Randomized participants who completed the 52 weeks of treatment had both baseline and week 52 HbA1c measurement and had no significant protocol deviations||Percent||Standard Error|Mean
753345|NCT00575666|Primary|Psychopathology- QLS Total|Quality of life was measured at Screening/Baseline, Week 4, and Week 8. Assessment consisted of 21 items, with each item measured on a seven-point scale (0= not present, 3= sometimes present, 6= always present). Min score= 0, Max score= 126. Higher scores represent lower quality of life. Week 8 values are displayed below.|Week 8|All subjects who completed the study for each Arm/Group were analyzed on psychopathology measures; study completion allows for calculation of change scores.||units on a scale||Standard Deviation|Mean
753346|NCT00575666|Primary|Psychopathology- CDSS Total|Symptoms of depression were measured at Screening/Baseline, Week 4, and Week 8. Assessment consisted of 9 items, with each item measured on a four-point scale (0= absent, 3= severe). Min score= 0, Max score= 27. Higher scores represent more advanced psychopathology. Week 8 values are displayed below.|Week 8|All subjects who completed the study for each Arm/Group were analyzed on psychopathology measures; study completion allows for calculation of change scores.||units on a scale||Standard Deviation|Mean
753347|NCT00575666|Primary|Psychopathology- SANS Total|Negative symptoms of schizophrenia were measured at Screening/Baseline, Week 4, and Week 8. Assessment consisted of 25 items, with each item measured on a six-point scale (0= none, 3= moderate, 5= severe). Min score= 0, Max score= 125. Higher scores represent more advanced psychopathology. Week 8 values are displayed below.|Week 8|All subjects who completed the study for each Arm/Group were analyzed on psychopathology measures; study completion allows for calculation of change scores.||units on a scale||Standard Deviation|Mean
753348|NCT00575666|Primary|Psychopathology- PANSS General Psychopathology|General psychopathology was measured at Screening/Baseline, Week 4, and Week 8. The assessment consisted of 16 items, with each item measured on a seven-point scale (1= absent, 4= moderate, 7= extreme). Min score= 16, Max score= 112. Higher scores represent more advanced psychopathology. Week 8 values are displayed below.|Week 8|All subjects who completed the study for each Arm/Group were analyzed on psychopathology measures; study completion allows for calculation of change scores.||units on a scale||Standard Deviation|Mean
753349|NCT00575666|Primary|Psychopathology- PANSS Negative|Negative symptoms of schizophrenia were measured at Screening/Baseline, Week 4, and Week 8. Assessment consisted of seven-items, with each item measured on a seven-point scale (1= absent, 4= moderate, 7= extreme). Min score= 7, Max score= 49. Higher scores represent more advanced psychopathology. Week 8 values are displayed below.|Week 8|All subjects who completed the study for each Arm/Group were analyzed on psychopathology measures; study completion allows for calculation of change scores.||units on a scale||Standard Deviation|Mean
753350|NCT00575666|Primary|Psychopathology- PANSS Positive|Positive symptoms of schizophrenia were measured at Screening/Baseline, Week 4, and Week 8. The assessment consisted of seven items, with each item measured on a seven-point scale (1= absent, 4= moderate, 7= extreme). Min score= 7, Max score= 49. Higher scores represent more advanced psychopathology. Week 8 values are displayed below.|Week 8|All subjects who completed the study for each Arm/Group were analyzed on psychopathology measures; study completion allows for calculation of change scores.||units on a scale||Standard Deviation|Mean
753351|NCT00575666|Primary|Psychopathology- PANSS Total|Positive symptoms, negative symptoms, and general psychopatholgy of schizophrenia were measured at Screening/Baseline, Week 4, and Week 8. The assessment consisted of 30 total items, with each item measured on a seven-point scale (1= absent, 4= moderate, 7= extreme). Min score= 30, Max score= 210. Higher scores represent more advanced psychopathology. Week 8 values are displayed below.|Week 8|All subjects who completed the study for each Arm/Group were analyzed on psychopathology measures; study completion allows for calculation of change scores.||units on a scale||Standard Deviation|Mean
753352|NCT00575666|Primary|Cognitive Function- CPT False-alarm Rate (Proportion)|Subjects completed a computer-based cognitive functioning test designed to measure sustained attention (attention to a stimulus over a period of several minutes). False alarm rate is defined as the proportion of overall hits that were in response to an incorrect stimulus (two consecutive non-identical targets). Assessments were completed at Screening/Baseline, Week 4, and Week 8. False-alarm hits were measured as a proportion of total hits. Min score= 0, Max score= 1.0. Lower values represent higher hit accuracy and less advanced psychopathology. Week 8 values are displayed below.|Week 8|All subjects who completed the study for each Arm/Group were analyzed on cognitive function measures; study completion allows for calculation of change scores.||Proportion of total hits||Standard Deviation|Mean
753353|NCT00575666|Primary|Cognitive Function- CPT Reaction Time of Hits (Milliseconds)|"Subjects completed a computer-based cognitive functioning test designed to measure sustained attention (attention to a stimulus over a period of several minutes). The test is described in detail in a previous outcome measure (CPT d prime score). Reaction time of hits is defined as the average time each participant took to respond correctly to relevant stimuli. Assessments were completed at Screening/Baseline, Week 4, and Week 8. Reaction time was measured in milliseconds. Max score= N/A. Lower values represent less advanced psychopathology. Week 8 values are displayed below."|Week 8|All subjects who completed the study for each Arm/Group were analyzed on cognitive function measures; study completion allows for calculation of change scores.||Milliseconds||Standard Deviation|Mean
753354|NCT00575666|Primary|Cognitive Function- CPT Hits Rate (Proportion)|"Subjects completed a computer-based cognitive test. The test is described in detail in a previous outcome measure (CPT d prime score). Hits rate was defined as the proportion of correct responses to the relevant stimuli (response to two identical targets) compared to total responses (total hits). Assessments were completed at Screening/Baseline, Week 4, and Week 8. Hits rate as a proportion of total hits was measured. Min score= 0, Max score= 1.0. Higher values represent higher stimulus recognition accuracy, and thus less advanced psychopathology. Week 8 values are displayed below."|Week 8|All subjects who completed the study for each Arm/Group were analyzed on cognitive function measures; study completion allows for calculation of change scores.||Proportion of total hits||Standard Deviation|Mean
753355|NCT00575666|Primary|Cognitive Function- CPT D Prime Score|"Subjects completed a computer-based cognitive test designed to measure sustained attention (attention to a specific stimulus over a period of several minutes) before and after intranasal treatment. During this test, participants respond as quickly as possible to any consecutive presentation of identical stimuli on the computer screen. The stimuli (2, 3, and 4-digit targets) were presented with increasing cognitive load in successive blocks. Correct responses, responses made to the second of 2 identical stimuli presented in a row, were scored as hits. False alarms were also recorded. The d prime score is a score given to each participant on a scale of 0.0- 1.0 in which discrimination sensitivity is measured. A score of zero equates to no sensitivity, whereas a score of 1.0 equates to perfect sensitivity. Values below represent postreatment performance minus pretreatment performance. Higher scores represent less advanced psychopathology. Week 8 values are displayed below."|Week 8|All subjects who completed the study for each Arm/Group were analyzed on cognitive function measures; study completion allows for calculation of change scores.||D prime score||Standard Deviation|Mean
753356|NCT00575666|Primary|Cognitive Function- Trails B|"Subjects completed a timed trails (i.e. connect the dots) test. Assessments were completed at Screening/Baseline, Week 4, and Week 8. Scores were mesured by time to complete in seconds. Max score= N/A. Lower values represent less advanced psychopathology. Week 8 values are displayed below."|Week 8|All subjects who completed the study for each Arm/Group were analyzed on cognitive function measures; study completion allows for calculation of change scores.||Seconds||Standard Deviation|Mean
753357|NCT00575666|Primary|Cognitive Function- Trails A|"Subjects completed a timed trails (i.e. connect-the-dots) test. Assessments were completed at Screening/Baseline, Week 4, and Week 8. Scores were measured by time to complete in seconds. Max score= N/A. Lower values represent less advanced psychopathology. Week 8 values are displayed below."|Week 8|All subjects who completed the study for each Arm/Group were analyzed on cognitive function measures; study completion allows for calculation of change scores.||Seconds||Standard Deviation|Mean
753358|NCT00575666|Primary|Cognitive Function- HVLT Delayed Recall Total|Subjects completed a delayed word recall task. Assessments were completed at Screening/Baseline, Week 4, and Week 8. Higher scores represent higher recall accuracy, and therefore less advanced psychopathology. Min score= 0, Max score= 12. Week 8 values are displayed below.|Week 8|All subjects who completed the study for each Arm/Group were analyzed on cognitive function measures; study completion allows for calculation of change scores.||Words correct||Standard Deviation|Mean
753359|NCT00575666|Primary|Cognitive Function- HVLT Immediate Recall Total|Subjects completed a word recall task. Assessment was completed at Screening/Baseline, Week 4, and Week 8. Higher scores represent higher recall accuracy, and therefore less advanced psychopathology. Min score= 0, Max score= 36. Week 8 values are displayed below.|Week 8|All subjects who completed the study for each Arm/Group were analyzed on cognitive function measures; study completion allows for calculation of change scores.||Words correct||Standard Deviation|Mean
753360|NCT00575666|Primary|Cognitive Function- Verbal Fluency|Subjects completed a verbal fluency test. Assessment was completed at Screening/Baseline, Week 4, and Week 8. Higher scores represent higher levels of verbal fluency, and therefore less advanced psychopathology. Min score= 0, Max score= N/A. Week 8 values are displayed below.|Week 8|All subjects who completed the study for each Arm/Group were analyzed on cognitive function measures; study completion allows for calculation of change scores.||Words correct||Standard Deviation|Mean
753361|NCT00575666|Primary|Cognitive Function- Digit Span Total|Subjects completed the digit span task. Assessment was completed at Screening/Baseline, Week 4, and Week 8. Higher scores represent higher recall accuracy, and therefore less advanced psychopathology. Min score= 0, Max score= 30. Week 8 values are displayed below.|Week 8|All subjects who completed the study for each Arm/Group were analyzed on cognitive function measures; study completion allows for calculation of change scores.||Items correct||Standard Deviation|Mean
753362|NCT00575887|Primary|Progression-free Survival at 6-months||Until progression|||percentage of participants|||Number
753363|NCT00575965|Primary|Progression-Free Survival|Progression-free survival is the defined as the time from study entry to disease progression (PD) or death based on Kaplan-Meier estimates. Patients alibe without PD are censored at the date of last disease evaluation. PD is defined as a greater than 25% increase in serum IgM monoclonal protein levels from the lowest attained response value as determined by serum electrophoresis, confirmed by at least one other investigation, or progression of clinically significant disease related symptom(s). [Consensus panel criteria: Weber et al, 2003; Kimby et al, 2005].|Assessed at month 1 and 3 and thereafter every 3 months while on therapy; Assessed every 6 months for up to 2 years of follow-up. Median follow-up in this study cohort was 6 months (range 2-18 months).|The analysis dataset is comprised of all evaluable patients. One patient was lost to follow-up within 3 weeks of enrollment and was unevaluable.||months||95% Confidence Interval|Median
753364|NCT00575965|Primary|Objective Response Rate|Objective response is defined as achieving partial response or better on therapy based on the Consensus Panel Recommendations from the 2nd and 3rd International Workshop on WM [Weber et al, 2003; Kimby et al, 2005]. Complete Response (CR): Complete disappearance of serum monoclonal (SM) Immunoglobulin (Ig) E (IgE), measured centrally; resolution of adenopathy/organomegaly upon physical exam and computerized tomography (CT) scan; lymph nodes =<1.5 centimeters; absence of malignant cell by bone marrow histologic examination. Partial Response (PR): a >=50% reduction from baseline in the SM IgM concentration. Minor Response (MR): >=25%, but a <50% reduction of SM IgM from baseline.|Assessed at month 1 and 3 and thereafter every 3 months while on therapy. Median duration on treatment was 6 months (range 1-24 months).|The analysis dataset is comprised of all evaluable patients. One patient was lost to follow-up within 3 weeks of enrollment and was unevaluable.||proportion of patients|||Number
753365|NCT00576056|Secondary|Determine the Overall Survival in Patients Treated With This Combination Regimen|Overall survival (OS) is calculated as the time interval between the date on which a patient first received protocol treatment and the documented date of death. For a surviving patient, OS is censored by the last follow-up date when that patient is documented to be alive.|From date of initial treatment until the date of death from any cause|Patients who received at least one cycle of the entire treatment regimen (this did not include two patients who went on to receive liver transplants).||days||Full Range|Median
753366|NCT00576056|Primary|Determine Progression-free Survival in This Patient Population Treated With the Proposed Combination Treatment Modality|Progression free survival (PFS) is calculated as the time interval between the date on which a patient first received protocol treatment and the documented date of disease progression or death. For a surviving and progression-free patient, PFS is censored by the last follow-up date when that patient is documented to be progression free. Progression is defined using RECIST v1.0, as a 20% increase in the sum of the longest diameter of target lesions, or a measureable increase in a non-target lesion, or the appearance of new lesions.|Up to 24 months (from initial treatment through 12 months follow-up)|Patients who received at least one cycle of the entire treatment regimen (this did not include two patients who went on to receive liver transplants).||days||Full Range|Median
753367|NCT00576147|Secondary|To Determine the Reproducibility of the Near-Infrared Spectroscopy (NIRS) Measurements With Different Operators and at Different Centers||2 years||||||
753368|NCT00576147|Primary|1) Sensitivity of the Near-Infrared Spectroscopy (NIRS) Measurements for Identifying Intracranial Hematomas Due to Trauma. 2) Specificity of the Near-Infrared Spectroscopy (NIRS) Measurements for Identifying Intracranial Hematomas Due to Trauma.|"We will report Sensitivity and Specificity of NIRS device as compared to CT scanner to detect hematomas of more than 3.5 mL in volume and less than 2.5 cm from the surface of the brain.
Sensitivity is the ratio between true positives to all positive measurements. Specificity is the ratio between true negatives to all negative measurements."|2 years|431 Total patients enrolled; 365 total patients evaluated after 66 excluded for protocol violations; 269 Number of patients with no Intracranial Hemorrhage; 96 Number of patients with confirmed intrcranial hemorrhage; 50 Number of patients with Intracranial hemorrhage within detection limits of the device.||Number of participants|||Number
753369|NCT00576199|Secondary|Tumor Necrosis|Tumor necrosis was quantified in liver lesions greater than 2 cm at Baseline. When MRI showed many cut surfaces for a single tumor, tumor size and the size of necrotic area was measured by accumulation of the serial sections containing the tumor. Lipiodol accumulation in tumor after TACE was regarded as an indication of necrosis. Tumor necrosis was assessed at Baseline and 1 week prior to the next scheduled transarterial chemoembolisation (TACE) for the first 4 TACEs, then 1 week prior to every second TACE till disease progression. The extent of tumor necrosis is presented as the percentage of the tumor volume at Baseline.|Baseline to the end of the study (up to 3 years, 3 months)|Intent-to-treat population: All participants who received study medication.||Percentage of tumor volume at Baseline||Standard Deviation|Mean
753370|NCT00576199|Secondary|Percentage of Participants With a Best Overall Response of Complete Response, Partial Response, or Stable Disease|A complete response was defined as the disappearance of all target lesions. A partial response was defined as at least a 30% decrease in the sum of the LD of target lesions taking as reference the Baseline sum LD. Stable disease was defined as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. All other lesions (or sites of disease) should be identified as non-target lesions. Target lesions should be selected on the basis of their size (lesions with the LD) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the LD for all target lesions will be calculated and reported as the Baseline sum LD.|Baseline to the end of the study (up to 3 years, 3 months)|Intent-to-treat population: All participants who received study medication.||Percentage of participants||95% Confidence Interval|Number
753371|NCT00576199|Secondary|Overall Survival|Overall survival was defined as the time from the first administration of study drug to death.|Baseline to the end of the study (up to 3 years, 3 months)|Intent-to-treat population: All participants who received study medication.||Months||95% Confidence Interval|Median
753372|NCT00576199|Secondary|Time to Progression|Time to progression was defined as the time from the first administration of study drug to the first documented disease progression. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. All other lesions (or sites of disease) should be identified as non-target lesions. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.|Baseline to the end of the study (up to 3 years, 3 months)|Intent-to-treat population: All participants who received study medication.||Months||95% Confidence Interval|Median
753373|NCT00576199|Secondary|Percentage of Participants With an Objective Response|An objective response was defined as a complete response or a partial response. A complete response was defined as the disappearance of all target lesions. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the Baseline sum longest diameter. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. All other lesions (or sites of disease) should be identified as non-target lesions. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.|Baseline to the end of the study (up to 3 years, 3 months)|Intent-to-treat population: All participants who received study medication.||Percentage of participants||95% Confidence Interval|Number
755312|NCT00593606|Primary|Change in Calcium|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||mg/dl||Standard Deviation|Mean
753374|NCT00576199|Primary|Progression-free Survival|Progression-free survival was defined as the time from the first administration of study drug to the first documented disease progression or death, whichever occurs first. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.|Baseline to the end of the study (up to 3 years, 3 months)|Intent-to-treat population: All participants who received study medication.||Months||95% Confidence Interval|Median
753375|NCT00576251|Primary|Percent of Patients Who Display Microbiological Success (Eradication of Baseline Pathogens at Day 4)|Microbiological success was declared if the pre-therapy pathogens were eradicated at the Exit Visit; conversely, microbiological failure was declared if pre-therapy pathogens persisted at the exit visit. The microbiological outcomes were calculated based on an algorithm that assessed whether pre-therapy pathogens were eradicated or persisted as demonstrated by comparative characterization of recovered bacteria.|Day 4 - Test Of Cure (TOC) compared to Day 0|||Percent of patients|||Number
753376|NCT00576303|Secondary|Number of Participants With Red Blood Cell Transfusion|The number of participants who underwent red blood cell transfusion was reported|Up to 3 years|The safety population was defined as all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not.||number of participants|||Number
753377|NCT00576303|Secondary|Number of Participants Requiring Any Dose Adjustment During the DTP, EEP, and LTSP|The number of participants who required dose adjustments of C.E.R.A were categorized as; 1. No dose change; 2. Any dose change: a. Dose increase only; b. Dose decrease only; c. Dose increase and increase; 3. Only one dose, all of which were recorded during DTP, EEP and LTSP. DTP is defined as Week 1 to Week 16, EEP is defined as Week 16 to Week 24 and LTSP is defined as Week 24 to Week 44|DTP (Week 1 to Week 16), EEP (Week 16 to Week 24) and LTSP (Week 24 to Week 44)|The ITT population included all the participants who received at least one dose of C.E.R.A. and for whom data for at least one follow-up variable is available. . Data for the participants present at the time of assessment was used for analysis i.e. for DTP- 199, EEP-183, LTSP-178 respectively.||number of participants|||Number
753378|NCT00576303|Secondary|Mean Number of Days Spent Within Hb Range of 10.5-12.5 g/dL During the EEP|The mean number of days the participant spent within the Hb range 10.5-12.5 g/dL during the EEP was reported. The EEP is defined as Week 16 to Week 24|EEP (Week 16 to Week 24)|The ITT population included all the participants who received at least one dose of C.E.R.A. and for whom data for at least one follow-up variable is available. Of the 199 participants, analysis was conducted on 184 participants, as 15 participants did not maintain their hemoglobin, within range of 10.5-12.5 g/dL during the EEP.||number of days||Standard Deviation|Mean
753379|NCT00576303|Secondary|Percentage of Participants Maintaining Average Hb Concentration Within Target Range of 10.5-12.5 g/dL Throughout the EEP|All mean Hb values recorded during the EEP were calculated. The percentage of participants maintaining their average Hb concentration within the targeted range 10.5-12.5 g/dL during the EEP were reported. The EEP is defined as Week 16 to Week 24|EEP (Week 16 to Week 24)|The ITT population included all the participants who received at least one dose of C.E.R.A. and for whom data for at least one follow-up variable is available.||percentage of participants||95% Confidence Interval|Number
753380|NCT00576303|Secondary|Mean Change in Hb Concentration From Baseline to the EEP|A time adjusted mean change in Hb concentration was calculated using an area under the curve approach, for both periods separately. Change in Hb concentration between the baseline and evaluation periods was calculated by subtracting the calculated average baseline Hb value from the average evaluation period Hb value. All blood samples for Hb measurements were taken prior to study drug administration. Analysis used last observation carried forward (LOCF) for missing Hb values to correct for the impact of early dropouts. The baseline period is defined as Week -4 to Week -1. The EEP is defined as Week 16 to Week 24|Baseline (Week -4 to Week -1), EEP (Week 16 to Week 24)|The Intent-to-Treat (ITT) population included all the participants who received at least one dose of C.E.R.A. and for whom data for at least one follow-up variable is available.||g/dL||Standard Deviation|Mean
753381|NCT00576303|Primary|Percentage of Participants Maintaining Average Hemoglobin Concentration Within +\- 1 Gram/Deciliter of Their Reference Hb and Between 10.5 and 12.5 Gram/Deciliter During EEP|All mean Hb values recorded during the evaluation period were calculated and subtracted from the mean baseline Hb value for each participant. The percentage of participants maintaining their mean Hemoglobin (Hb) concentration within +/- 1 gram/deciliter (g/dL) of their reference Hb and between 10.5 -12.5 g/dL is presented during the EEP. The EEP is defined as Week 16 to Week 24|EEP (Week 16 to Week 24)|Per protocol (PP) population included participants except who didn’t meet inclusion criterion relative to consent, stable baseline Hb values, iron status, epoetin maintenance, and who met exclusion criterion of hemoglobinopathies/hemolysis, bleeding, >3 recorded Hb, missing drug administration, other ESA, blood transfusion during the DTP or EEP.||percentage of participants||95% Confidence Interval|Number
753382|NCT00576316|Secondary|Changes in Asthma Control Questionnaire (ACQ-5) Score From Baseline to the Mean of 3 Months and 6 Months After Patient Was Initially Treated With SMART|Difference/change in ACQ-5 scores between baseline and mean of 3 months and 6 months after SMART treatment. ACQ-5 is a 5 question patient reported outcome measuring level of asthma control during the past 7 days and it is scored on scale of 0-6. 0 indicates no symptoms and 6 represents severe symptoms|6 months after each patient was initially treated with Symbicort SMART|201 participants were recruited but statistical analysis was completed for 195 participants||scores on a scale||Standard Deviation|Mean
753383|NCT00576316|Primary|Change in Satisfaction With Asthma Treatment Questionnaire (SATQ) Scores From Baseline to the Mean of 3 Months and 6 Months After Patient Was Initially Treated With SMART|Difference/change in SATQ score between baseline and mean of 3 months and 6 months after SMART treatment as analysed by paired t-test. SATQ is a patient reported questionnaire which consists of 26 questions and scored to a scale of 1-7, the higher score indicating a greater level of satisfaction|6 months after each patient was initially treated with Symbicort SMART|201 participants were recruited but statistical analysis was completed for 195 participants||Scores on a scale||Standard Deviation|Mean
753384|NCT00576381|Primary|PK Profile of Dexmedetomidine|This study measured the concentration of dex in the body and used those concentrations to determine how quickly the body metabolizes and eliminates dex(concentration-time or pharmacokinetic profile).The concentration of dex in the body is determined through serial blood sampling while administering dex and following discontinuation.|A sparse PK sampling method was utilized. Between 6-12 PK samples were drawn : After start of infusion (0.5, 4-6, 8 hours), immediately prior to end of infusion and following end of infusion (0.25, 0.5, 1, 2-4, 6-8, 10-12 & 18hrs)|Based on an estimated inter-subject variability of 50% for clearance, a sample size of 32 evaluable subjects will be sufficient to detect an 18% difference (alpha 0.05, power 0.9) in the clearance in this population (38 + 18 L/hr) versus that previously reported in the adult population (46 L/hr).||mL/min||Standard Error|Least Squares Mean
753385|NCT00576420|Primary|Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Severe Bleeding|"Investigators were shown videos of bleeding severities to standardize assessments.
Severe bleeding defined as:
Either >50% of the suture line bleeds, or
≥10 suture line bleedings were present, if counting of suture line bleedings was possible, or
>1 pulsatile suture line bleeding was present, or
≥1 spurting suture line bleeding was present."|4 minutes post start of treatment application|Intent to Treat||percentage of participants||90% Confidence Interval|Number
753386|NCT00576420|Secondary|Laboratory Values Over Time: International Normalized Ratio (INR)||Preoperative baseline through postoperative Day 14|Safety Analysis Set||ratio||Full Range|Median
753387|NCT00576420|Secondary|Laboratory Values Over Time: Activated Partial Thromboplastin Time (aPTT)||Preoperative baseline through postoperative Day 14|Safety Analysis Set||seconds||Full Range|Median
753388|NCT00576420|Secondary|Laboratory Values Over Time: Aspartate Aminotransferase (AST)||Preoperative baseline through postoperative Day 14|Safety Analysis Set||U/L||Full Range|Median
753389|NCT00576420|Secondary|Laboratory Values Over Time: Alanine Aminotransferase (ALT)||Preoperative baseline through postoperative Day 14|Safety Analysis Set||U/L||Full Range|Median
753390|NCT00576420|Secondary|Laboratory Values Over Time: Creatinine, Bilirubin, and Blood Urea Nitrogen (BUN)||Preoperative baseline through postoperative Day 14|Safety Analysis Set||mg/dL||Full Range|Median
753391|NCT00576420|Secondary|Laboratory Values Over Time: Platelets||Preoperative baseline through postoperative Day 14|Safety Analysis Set||x10^3/µl||Full Range|Median
753392|NCT00576420|Secondary|Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes||Preoperative baseline through postoperative Day 14|Safety Analysis Set||x10^3/µl||Full Range|Median
753393|NCT00576420|Secondary|Laboratory Values Over Time: Erythrocytes||Preoperative baseline through postoperative Day 14|Safety Analysis Set||x10^6/µl||Full Range|Median
753394|NCT00576420|Secondary|Laboratory Values Over Time: Hematocrit||Preoperative baseline through postoperative Day 14|Safety Analysis Set||percentage of red blood cells in blood||Full Range|Median
753395|NCT00576420|Secondary|Laboratory Values Over Time: Hemoglobin||Preoperative baseline through postoperative Day 14|Safety Analysis Set||g/dl||Full Range|Median
753396|NCT00576420|Secondary|Percent Change in Vital Signs: Respiratory Rate|Percent Change in Respiratory Rate Measured as: Preoperative Baseline - Intraoperative Day 0; Preoperative Baseline - Postoperative Day 1; and Preoperative Baseline - Postoperative Day 14|Preoperative baseline through postoperative Day 14|Safety Analysis Set||percent change||Full Range|Median
753397|NCT00576420|Secondary|Vital Signs: Respiratory Rate - Preoperative Baseline||Within 14 days prior to date of surgery|Safety Analysis Set||Breaths/ minute||Full Range|Median
753398|NCT00576420|Secondary|Percent Change in Vital Signs: Heart Rate|Percent Change in Heart Rate Measured as: Preoperative Baseline - Intraoperative Day 0; Preoperative Baseline - Postoperative Day 1; and Preoperative Baseline - Postoperative Day 14|Preoperative baseline through postoperative Day 14|Safety Analysis Set||percent change||Full Range|Median
753399|NCT00576420|Secondary|Vital Signs: Heart Rate - Preoperative Baseline||Within 14 days prior to date of surgery|Safety Analysis Set||Heart beats/ minute||Full Range|Median
753400|NCT00576420|Secondary|Percent Change in Vital Signs: Systolic and Diastolic Blood Pressure|Percent Change in Systolic and Diastolic Blood Pressure (BP) Measured as: Preoperative Baseline – Intraoperative Day 0; Preoperative Baseline – Postoperative Day 1; and Preoperative Baseline – Postoperative Day 14|Preoperative baseline through postoperative Day 14|Safety Analysis Set||percent change||Full Range|Median
753401|NCT00576420|Secondary|Vital Signs: Systolic and Diastolic Blood Pressure - Preoperative Baseline||Within 14 days prior to date of surgery|Safety Analysis Set||mm Hg||Full Range|Median
753402|NCT00576420|Secondary|Percentage of Participants With Infections at the Surgical Site||Day 0 (procedure day) through day 30 ± 5|Safety Analysis Set||percentage of participants||90% Confidence Interval|Number
753403|NCT00576420|Secondary|Percentage of Participants With Graft Occlusions|Determined clinically and defined as absence of blood flow through the graft.|Day 0 (procedure day) through day 30 ± 5|Safety Analysis Set||percentage of participants||90% Confidence Interval|Number
753404|NCT00576420|Secondary|Percentage of Participants With Any Transfusion Requirement|Proportion of participants who required transfusions (i.e., red blood cell (RBC) concentrates, fresh frozen plasma (FFP), and platelets)|Intraoperative (day 0) through day 30 ± 5|Intent to Treat||percentage of participants||90% Confidence Interval|Number
753405|NCT00576420|Secondary|Percentage of Participants With Postoperative Rebleeding After Hemostasis at the Study Suture Line|Any rebleeding requiring surgical reexploration|Postoperative through day 30 ± 5|Intent to Treat||percentage of participants||90% Confidence Interval|Number
753406|NCT00576420|Secondary|Percentage of Participants With Intraoperative Rebleeding After Hemostasis at the Study Suture Line|Intraoperative rebleeding at the study suture line after occurrence of hemostasis.|Intraoperative day 0|Intent to Treat||percentage of participants||90% Confidence Interval|Number
753407|NCT00576420|Secondary|Percentage of Participants Achieving Hemostasis at 10 Minutes|Hemostasis at the study suture line must be maintained until closure of the surgical wound.|10 minutes post start of treatment application|Intent to Treat||percentage of participants||90% Confidence Interval|Number
753408|NCT00576420|Secondary|Percentage of Participants Achieving Hemostasis at 6 Minutes|Hemostasis at the study suture line must be maintained until closure of the surgical wound.|6 minutes post start of treatment application start|Intent to Treat||percentage of participants||90% Confidence Interval|Number
753409|NCT00576420|Primary|Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Moderate Bleeding|"Investigators were shown videos of bleeding severities to standardize assessments.
Moderate bleeding defined as:
Either >25% of the suture line bleeds, or
≥5 suture line bleedings were present, if counting of suture line bleedings was possible, or
1 pulsatile suture line bleeding was present.
Severe bleeding defined as:
Either >50% of the suture line bleeds, or
≥10 suture line bleedings were present, if counting of suture line bleedings was possible, or
>1 pulsatile suture line bleeding was present, or
≥1 spurting suture line bleeding was present."|4 minutes post start of treatment application|Intent to Treat||percentage of participants||90% Confidence Interval|Number
753410|NCT00576420|Primary|90% Confidence Interval for the Percentage of Participants Achieving Hemostasis at 4 Minutes After Treatment Application at the Suture Line|"Hemostasis at the study suture line must be maintained until closure of the surgical wound.
Participants were considered treatment failures if they met any of the following conditions:
Did not achieve hemostasis at 4 minutes
Required additional hemostatic treatment other than study treatment during the first 4 minutes of the observation period
Experienced rebleeding after the first 4 minutes of the observation period."|4 minutes post start of treatment application|Intent to Treat||percentage of participants||90% Confidence Interval|Number
753411|NCT00576420|Primary|Percentage of Participants Achieving Hemostasis at 4 Minutes After Treatment Application at the Study Suture Line.|"Hemostasis at the study suture line must be maintained.
Participants were considered treatment failures if they met any of the following conditions:
Did not achieve hemostasis at 4 minutes
Required additional hemostatic treatment during the first 4 minutes of the observation period
Experienced rebleeding after the first 4 minutes of the observation period."|4 minutes post start of treatment application|Intent to Treat||percentage of participants|||Number
753412|NCT00576472|Secondary|Establish the Effectiveness of MPH on Laboratory Measures of Interference, Impulsivity, Cognitive Flexibility, and Selective Attention Using the Stroop Word-Color Association Test (Stroop) for Interference Score.|Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We are interested in testing the difference of effects of MPH and placebo, not in testing the difference of two sequence groups. We will use the Stroop Word-Color Association Test (Stroop) to estimate the effectiveness of MPH on laboratory measures of interference, impulsivity, cognitive flexibility, and selective attention. Stroop T scores for Interference Score have a mean of 50 and a standard deviation of 10.|Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo.|A mixed model was used to estimate the means of MPH and Placebo accounting for carry-over effects in the In-Lab crossover phase.||Estimated T Score||Standard Error|Mean
753413|NCT00576472|Secondary|Establish the Effectiveness of MPH on Laboratory Measures of Interference, Impulsivity, Cognitive Flexibility, and Selective Attention Using the Stroop Word-Color Association Test (Stroop) for Ink Color Naming Time.|Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We are interested in testing the difference of effects of MPH and placebo, not in testing the difference of two sequence groups. We will use the Stroop Word-Color Association Test (Stroop) to estimate the effectiveness of MPH on laboratory measures of interference, impulsivity, cognitive flexibility, and selective attention. Stroop T scores for Ink Color Naming Time have a mean of 50 and a standard deviation of 10.|Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo.|A mixed model was used to estimate the means of MPH and Placebo accounting for carry-over effects in the In-Lab crossover phase.||Estimated T Score||Standard Error|Mean
753414|NCT00576472|Secondary|Establish the Effectiveness of MPH on Laboratory Measures of Interference, Impulsivity, Cognitive Flexibility, and Selective Attention Using the Stroop Word-Color Association Test (Stroop) for Color Naming Time.|Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We are interested in testing the difference of effects of MPH and placebo, not in testing the difference of two sequence groups. We will use the Stroop Word-Color Association Test (Stroop) to estimate the effectiveness of MPH on laboratory measures of interference, impulsivity, cognitive flexibility, and selective attention. Stroop T scores for Color Naming Time have a mean of 50 and a standard deviation of 10.|Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo.|A mixed model was used to estimate the means of MPH and Placebo accounting for carry-over effects in the In-Lab crossover phase.||Estimated T Score||Standard Error|Mean
753415|NCT00576472|Secondary|Establish the Effectiveness of MPH on Laboratory Measures of Interference, Impulsivity, Cognitive Flexibility, and Selective Attention Using the Stroop Word-Color Association Test (Stroop) for Word Naming Time.|Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We are interested in testing the difference of effects of MPH and placebo, not in testing the difference of two sequence groups. We will use the Stroop Word-Color Association Test (Stroop) to estimate the effectiveness of MPH on laboratory measures of interference, impulsivity, cognitive flexibility, and selective attention. Stroop T scores for Word Naming Time have a mean of 50 and a standard deviation of 10.|Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo.|A mixed model was used to estimate the means of MPH and Placebo accounting for carry-over effects in the In-Lab crossover phase.||Estimated T Score||Standard Error|Mean
753416|NCT00576472|Secondary|Establish the Effectiveness of MPH on Laboratory Measures of Learning and Recall Using California Verbal Learning Test (CVLT) for Long Delay Free Recall.|Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We are interested in testing the difference of effects of MPH and placebo, not in testing the difference of two sequence groups. We will use the California Verbal Learning Test (CVLT) to estimate the effectiveness of MPH on laboratory measures of learning and recall. CVLT Z Score for Long Delay Free Recall has a mean of 0 and a standard deviation of 1.|Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo.|A mixed model was used to estimate the means of MPH and Placebo accounting for carry-over effects in the In-Lab crossover phase.||Estimated Z Score||Standard Error|Mean
753535|NCT00577083|Primary|Number of Adenomas|Cap Fitted Colonoscopy (CFC) may significantly reduced miss rates for colorectal adenomas, specifically for small adenomas. This study is the first North American study of any design and the largest tandem study of CFC. CFC is a safe, simple, and inexpensive technology that could improve the reliability of colonoscopy in detecting colorectal neoplasia. Additional study of CFC in Western populations is warranted.|after the second colonoscopy is completed|||First Colonoscopy number of adenomas|||Number
753417|NCT00576472|Secondary|Establish the Effectiveness of MPH on Laboratory Measures of Learning and Recall Using California Verbal Learning Test (CVLT) for Short Delay Free Recall.|Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We are interested in testing the difference of effects of MPH and placebo, not in testing the difference of two sequence groups. We will use the California Verbal Learning Test (CVLT) to estimate the effectiveness of MPH on laboratory measures of learning and recall. CVLT Z Score for Short Delay Free Recall has a mean of 0 and a standard deviation of 1.|Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo.|A mixed model was used to estimate the means of MPH and Placebo accounting for carry-over effects in the In-Lab crossover phase.||Estimated Z Score||Standard Error|Mean
753418|NCT00576472|Secondary|Establish the Effectiveness of MPH on Laboratory Measures of Learning and Recall Using California Verbal Learning Test (CVLT) Over Five Learning Trials.|Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We are interested in testing the difference of effects of MPH and placebo, not in testing the difference of two sequence groups. We will use the California Verbal Learning Test (CVLT) to estimate the effectiveness of MPH on laboratory measures of learning and recall. CVLT Trials 1-5 have a mean T Score of 50 and Standard Deviation of 10.|Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo.|A mixed model was used to estimate the means of MPH and Placebo accounting for carry-over effects in the In-Lab crossover phase.||Estimated T Score||Standard Error|Mean
753419|NCT00576472|Secondary|Establish the Effectiveness of MPH on Laboratory Measures of Sustained Attention, Reaction Time, and, Impulsivity Using Conner’s Continuous Performance Test (CPT) for Beta (Risk Taking).|Change in raw scores for the shortened version of the Conner’s CPT from Baseline to Post-dose. The continuous performance test used during the in-lab trial was developed in house using SuperLab Pro v2.0 (Cedrus Corp., Phoenix, AZ). The test was modeled after Conners' CPT, but was shortened for ease of administration and evaluation of short-form sensitivity. The test is one-sixth the length of the Conners’ CPT, lasting 2.33 min with 54 total targets and six nontargets (10% of trials). Similar to the Conners’ CPT, the interstimulus intervals also varied by trial blocks with lengths of 1, 2, or 4 s. D′ and β are derived variables from signal detection theory. β is a measure of response tendency; higher scores indicate a more conservative response pattern. β was calculated using the formula = –d′*.5*(NORMSINV(hits)-NORMSINV(false alarms)). In the case where the false alarm rate = 0 or the hit rate = 1.0, we used the standard correction of 1/2N and 1- 1/2N, respectively.|Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo.|A mixed model was used to estimate the means of MPH and Placebo accounting for carry-over effects in the In-Lab crossover phase.||Estimated raw score||Standard Error|Mean
753420|NCT00576472|Secondary|Establish the Effectiveness of MPH on Laboratory Measures of Sustained Attention, Reaction Time, and, Impulsivity Using Conner's Continuous Performance Test (CPT) for d’ (Sensitivity).|Change in raw scores for the shortened version of the Conner’s CPT from Baseline to Post-dose. The continuous performance test used during the in-lab trial was developed in house using SuperLab Pro v2.0 (Cedrus Corp., Phoenix, AZ). The test was modeled after Conners' CPT, but was shortened for ease of administration and evaluation of short-form sensitivity. The test is one-sixth the length of the Conners’ CPT, lasting 2.33 min with 54 total targets and six nontargets (10% of trials). Similar to the Conners’ CPT, the interstimulus intervals also varied by trial blocks with lengths of 1, 2, or 4 s. D′ and β are derived variables from signal detection theory. D′ is a measure of sensitivity of a person to the signal or target; a higher score is indicative of better performance or better sustained attention. D′ was calculated as z(hit) – z(commission). Z-scores were calculated using the NORMSINV function in Microsoft Excel.|Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo.|A mixed model was used to estimate the means of MPH and Placebo accounting for carry-over effects in the In-Lab crossover phase.||Estimated raw score||Standard Error|Mean
753421|NCT00576472|Secondary|Establish the Effectiveness of MPH on Laboratory Measures of Sustained Attention, Reaction Time, and, Impulsivity Using Conner’s Continuous Performance Test (CPT) for Hit Reaction Time.|Change in raw scores for the shortened version of the Conner’s CPT from Baseline to Post-dose. The continuous performance test used during the in-lab trial was developed in house using SuperLab Pro v2.0 (Cedrus Corp., Phoenix, AZ). The test was modeled after Conners' CPT, but was shortened for ease of administration and evaluation of short-form sensitivity. The test is one-sixth the length of the Conners’ CPT, lasting 2.33 min with 54 total targets and six nontargets (10% of trials). Similar to the Conners’ CPT, the interstimulus intervals also varied by trial blocks with lengths of 1, 2, or 4 s. Hit reaction time is average reaction time in milliseconds for all correct responses when targets were presented. There is no pre-defined range for reaction time; higher score is indicative of slower processing speed.|Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo.|A mixed model was used to estimate the means of MPH and Placebo accounting for carry-over effects in the In-Lab crossover phase.||Estimated raw score||Standard Error|Mean
753422|NCT00576472|Secondary|Establish the Effectiveness of MPH on Laboratory Measures of Sustained Attention, Reaction Time, and, Impulsivity Using Conner's Continuous Performance Test (CPT) for Commission Errors.|Change in raw scores for the shortened version of the Conner’s CPT from Baseline to Post-dose. The continuous performance test used during the in-lab trial was developed in house using SuperLab Pro v2.0 (Cedrus Corp., Phoenix, AZ). The test was modeled after Conners' CPT, but was shortened for ease of administration and evaluation of short-form sensitivity. The test is one-sixth the length of the Conners’ CPT, lasting 2.33 min with 54 total targets and six nontargets (10% of trials). Similar to the Conners’ CPT, the interstimulus intervals also varied by trial blocks with lengths of 1, 2, or 4 s. Commission errors are the raw score for the numbers of nontargets presented where the subject incorrectly responded. Accordingly, the range for this variable is 0-6 with a higher score indicative of worse performance or impulsivity.|Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo.|A mixed model was used to estimate the means of MPH and Placebo accounting for carry-over effects in the In-Lab crossover phase.||Estimated raw score||Standard Error|Mean
753563|NCT00577135|Secondary|Dyspnea VAS|Dyspnea Visual Analog Scale Scale Range 0-7200; higher score is better|72 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.||units on a scale||Standard Deviation|Mean
753423|NCT00576472|Secondary|Establish the Effectiveness of MPH on Laboratory Measures of Sustained Attention, Reaction Time, and, Impulsivity Using Conner’s Continuous Performance Test (CPT) for Omission Errors.|Change in raw scores for the shortened version of the Conner’s CPT from Baseline to Post-dose. The continuous performance test used during the in-lab trial was developed in house using SuperLab Pro v2.0 (Cedrus Corp., Phoenix, AZ). The test was modeled after Conners' CPT, but was shortened for ease of administration and evaluation of short-form sensitivity. The test is one-sixth the length of the Conners’ CPT, lasting 2.33 min with 54 total targets and six nontargets (10% of trials). Similar to the Conners’ CPT, the interstimulus intervals also varied by trial blocks with lengths of 1, 2, or 4 s. Omission errors are the raw score for the number of targets presented where the subject did not respond. Accordingly, the range for this variable is 0-54 with a higher score indicative of worse performance or problems with sustained attention.|Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo.|A mixed model was used to estimate the means of MPH and Placebo accounting for carry-over effects in the In-Lab crossover phase.||Estimated raw score||Standard Error|Mean
753424|NCT00576472|Secondary|Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by Social Skills Rating System - Teacher (SSRS-T) – Problem Behavior.|The SSRS assesses social skills for children and adolescents at preschool, elementary and secondary developmental levels. The SSRS is 40 to 57 items, depending on age, completed separately by parents (SSRS-P) and teachers (SSRS-T). Respondents rate the frequency of occurrence for each item ranging from 0 to 2 (0-never, 1-sometimes, 2-very often). The raw scores for the SSRS-P and SSRS-T Social Skills Scales and the SSRS-P and SSRS-T Problem Behaviors Scales have different ranges that are dependent upon age. Raw scores obtained from the SSRS Scales cannot be used to directly interpret social skills or problem behaviors as raw scores vary in meaning based on scale, informant form and developmental level. Raw scores are converted to standard scores with a mean of 100 ± 15. For the Social Skills Scale, a higher score is indicative of better social functioning, and for the Problem Behaviors Scale, a higher score is indicative of greater behavior problems.|Evaluated at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks.|122 children began the Home Crossover Trial. 121 received all the placebo, 119 received all of the low dose, and 109 received all of the moderate dose.||Estimated Standard Score||Standard Error|Mean
753425|NCT00576472|Secondary|Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by Social Skills Rating System - Teacher (SSRS-T) – Social Skill.|The SSRS assesses social skills for children and adolescents at preschool, elementary and secondary developmental levels. The SSRS is 40 to 57 items, depending on age, completed separately by parents (SSRS-P) and teachers (SSRS-T). Respondents rate the frequency of occurrence for each item ranging from 0 to 2 (0-never, 1-sometimes, 2-very often). The raw scores for the SSRS-P and SSRS-T Social Skills Scales and the SSRS-P and SSRS-T Problem Behaviors Scales have different ranges that are dependent upon age. Raw scores obtained from the SSRS Scales cannot be used to directly interpret social skills or problem behaviors as raw scores vary in meaning based on scale, informant form and developmental level. Raw scores are converted to standard scores with a mean of 100 ± 15. For the Social Skills Scale, a higher score is indicative of better social functioning, and for the Problem Behaviors Scale, a higher score is indicative of greater behavior problems.|Evaluated at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks.|122 children began the Home Crossover Trial. 121 received all the placebo, 119 received all of the low dose, and 109 received all of the moderate dose.||Estimated Standard Score||Standard Error|Mean
753426|NCT00576472|Secondary|Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by Social Skills Rating System - Parent (SSRS-P) – Problem Behavior.|The SSRS assesses social skills for children and adolescents at preschool, elementary and secondary developmental levels. The SSRS is 40 to 57 items, depending on age, completed separately by parents (SSRS-P) and teachers (SSRS-T). Respondents rate the frequency of occurrence for each item ranging from 0 to 2 (0-never, 1-sometimes, 2-very often). The raw scores for the SSRS-P and SSRS-T Social Skills Scales and the SSRS-P and SSRS-T Problem Behaviors Scales have different ranges that are dependent upon age. Raw scores obtained from the SSRS Scales cannot be used to directly interpret social skills or problem behaviors as raw scores vary in meaning based on scale, informant form and developmental level. Raw scores are converted to standard scores with a mean of 100 ± 15. For the Social Skills Scale, a higher score is indicative of better social functioning, and for the Problem Behaviors Scale, a higher score is indicative of greater behavior problems.|Evaluated at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks.|122 children began the Home Crossover Trial. 121 received all the placebo, 119 received all of the low dose, and 109 received all of the moderate dose.||Estimated Standard Score||Standard Error|Mean
753427|NCT00576472|Secondary|Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by Social Skills Rating System - Parent (SSRS-P) – Social Skill.|The SSRS assesses social skills for children and adolescents at preschool, elementary and secondary developmental levels. The SSRS is 40 to 57 items, depending on age, completed separately by parents (SSRS-P) and teachers (SSRS-T). Respondents rate the frequency of occurrence for each item ranging from 0 to 2 (0-never, 1-sometimes, 2-very often). The raw scores for the SSRS-P and SSRS-T Social Skills Scales and the SSRS-P and SSRS-T Problem Behaviors Scales have different ranges that are dependent upon age. Raw scores obtained from the SSRS Scales cannot be used to directly interpret social skills or problem behaviors as raw scores vary in meaning based on scale, informant form and developmental level. Raw scores are converted to standard scores with a mean of 100 ± 15. For the Social Skills Scale, a higher score is indicative of better social functioning, and for the Problem Behaviors Scale, a higher score is indicative of greater behavior problems.|Evaluated at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks.|122 children began the Home Crossover Trial. 121 received all the placebo, 119 received all of the low dose, and 109 received all of the moderate dose.||Estimated Standard Score||Standard Error|Mean
753542|NCT00577096|Primary|Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets. (Long Term)||up to 30 weeks|For the exercise group 8 participants who entered the study were not included in the analysis (2 withdrew from myeloma treatment, 1 died, 5 withdrew from study). For the usual care group 7 were not included in the analysis (3 withdrew from myeloma treatment, 1 died, 3 withdrew from study).||Platelet Transfusions||Standard Deviation|Mean
753428|NCT00576472|Secondary|Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by The Conners’ Teacher Rating Scale (CTRS) ADHD Index.|The Conners' Teacher Rating Scale-Revised (S) is a measure of the observed frequency of behaviors associated with ADHD. Three scales are reported: Cognitive Problems/Inattention (assesses the ability to learn at the same pace as peers, organize and complete work, and concentrate for sustained periods of time), Hyperactivity (assesses the ability to sit still to complete tasks, and impulsivity) and ADHD Index (assesses risk for ADHD disorder to be corroborated by other clinical information). Raw scores are converted to T scores using age and gender normative data. T scores have a mean of 50 ± 10 where higher scores are indicative of greater problems. Assessments were performed at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks.|Evaluated at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks|122 children began the Home Crossover Trial. 121 received all the placebo, 119 received all of the low dose, and 109 received all of the moderate dose.||Estimated T Score||Standard Error|Mean
753429|NCT00576472|Secondary|Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by The Conners’ Teacher Rating Scale (CTRS) Hyperactivity Scale.|The Conners' Teacher Rating Scale-Revised (S) is a measure of the observed frequency of behaviors associated with ADHD. Three scales are reported: Cognitive Problems/Inattention (assesses the ability to learn at the same pace as peers, organize and complete work, and concentrate for sustained periods of time), Hyperactivity (assesses the ability to sit still to complete tasks, and impulsivity) and ADHD Index (assesses risk for ADHD disorder to be corroborated by other clinical information). Raw scores are converted to T scores using age and gender normative data. T scores have a mean of 50 ± 10 where higher scores are indicative of greater problems. Assessments were performed at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks.|Evaluated at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks.|122 children began the Home Crossover Trial. 121 received all the placebo, 119 received all of the low dose, and 109 received all of the moderate dose.||Estimated T Score||Standard Error|Mean
753430|NCT00576472|Secondary|Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by The Conners’ Teacher Rating Scale (CTRS) Cognitive Problem/Inattention Scale.|The Conners' Teacher Rating Scale-Revised (S) is a measure of the observed frequency of behaviors associated with ADHD. Three scales are reported: Cognitive Problems/Inattention (assesses the ability to learn at the same pace as peers, organize and complete work, and concentrate for sustained periods of time), Hyperactivity (assesses the ability to sit still to complete tasks, and impulsivity) and ADHD Index (assesses risk for ADHD disorder to be corroborated by other clinical information). Raw scores are converted to T scores using age and gender normative data. T scores have a mean of 50 ± 10 where higher scores are indicative of greater problems. Assessments were performed at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks.|Evaluated at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks.|122 children began the Home Crossover Trial. 121 received all the placebo, 119 received all of the low dose, and 109 received all of the moderate dose.||Estimated T Score||Standard Error|Mean
753431|NCT00576472|Secondary|Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by The Conners’ Parent Rating Scale (CPRS) ADHD Index.|The Conners’ Parent Rating Scale- Revised (S) is a measure of the observed frequency of behaviors associated with ADHD. Three scales are reported: Cognitive Problems/Inattention (assesses the ability to learn at the same pace as peers, organize and complete work, and concentrate for sustained periods of time), Hyperactivity (assesses the ability to sit still to complete tasks, and impulsivity) and ADHD Index (assesses risk for ADHD disorder to be corroborated by other clinical information). Raw scores are converted to T scores using age and gender normative data. T scores have a mean of 50 ± 10 where higher scores are indicative of greater problems. Assessments were performed at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks.|Evaluated at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks.|122 children began the Home Crossover Trial. 121 received all the placebo, 119 received all of the low dose, and 109 received all of the moderate dose.||Estimated T Score||Standard Error|Mean
753432|NCT00576472|Secondary|Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by The Conners’ Parent Rating Scale (CPRS) Hyperactivity Scale.|The Conners’ Parent Rating Scale- Revised (S) is a measure of the observed frequency of behaviors associated with ADHD. Three scales are reported: Cognitive Problems/Inattention (assesses the ability to learn at the same pace as peers, organize and complete work, and concentrate for sustained periods of time), Hyperactivity (assesses the ability to sit still to complete tasks, and impulsivity) and ADHD Index (assesses risk for ADHD disorder to be corroborated by other clinical information). Raw scores are converted to T scores using age and gender normative data. T scores have a mean of 50 ± 10 where higher scores are indicative of greater problems. Assessments were performed at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks.|Evaluated at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks.|122 children began the Home Crossover Trial. 121 received all the placebo, 119 received all of the low dose, and 109 received all of the moderate dose.||Estimated T Score||Standard Error|Mean
753433|NCT00576472|Secondary|Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by The Conners’ Parent Rating Scale (CPRS) Cognitive Problem/Inattention Scale.|The Conners’ Parent Rating Scale- Revised (S) is a measure of the observed frequency of behaviors associated with ADHD. Three scales are reported: Cognitive Problems/Inattention (assesses the ability to learn at the same pace as peers, organize and complete work, and concentrate for sustained periods of time), Hyperactivity (assesses the ability to sit still to complete tasks, and impulsivity) and ADHD Index (assesses risk for ADHD disorder to be corroborated by other clinical information). Raw scores are converted to T scores using age and gender normative data. T scores have a mean of 50 ± 10 where higher scores are indicative of greater problems. Assessments were performed at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks.|Evaluated at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks.|122 children began the Home Crossover Trial. 121 received all the placebo, 119 received all of the low dose, and 109 received all of the moderate dose.||Estimated T Score||Standard Error|Mean
753434|NCT00576472|Secondary|Best Weekly Score Measured by Conners' Parent Rating Scale (CPRS: ADHD T Score) During the 3-week Home Crossover Phase.|The Conners' Teacher Rating Scale- Revised (S) is a measure of the observed frequency of behaviors associated with ADHD. Twenty-seven questions are rated on a scale from 0 (not true at all) to 3 (very much true). Raw scores are converted to T scores using age and gender normative data. T scores have a mean of 50 ± 10 where higher scores are indicative of greater problems. Assessments were done weekly during the 3-week Home Crossover Period with the best response being used as the measurement for the test.|weekly during 3-week home crossover phase|There were 122 patients treated in the home crossover period. Some patients had missing treatments and outcome assessments. A crossover design was used for better efficiency of test and better precision of estimation.||T score||95% Confidence Interval|Mean
753435|NCT00576472|Primary|Change From Maintenance Phase Baseline to Completion of Phase as Measured by Wechsler Individual Achievement Test (WIAT) Math: Composite Standard Score|The Wechsler Individual Achievement Test is an examiner administered measure of academic skills. The Math Composite score assesses the child’s ability to solve calculation problems (Numerical Operations) and solve applied, word problems (Math Reasoning). Raw scores are converted to standard scores with a mean of 100±15 where higher scores indicate better performance. Assessments were performed prior to beginning the Home Therapy Phase (baseline) and upon completion of the phase. Phase completion ranged between 11.44 to 24.36 months|From beginning and after completion of home maintenance phase, on average 16.3 months.|118 patients began the MPH Home Maintenance Phase of the trial. 68 completed the year long phase. 68 were screened at the beginning of the trial using the Wechsler Individual Achievement Test (WIAT) Math: Composite Standard Score System. 68 were screened at completion. 68 patients were analyzed.||T-score||95% Confidence Interval|Mean
753436|NCT00576472|Primary|Change From Maintenance Phase Baseline to Completion of Phase as Measured by Wechsler Individual Achievement Test (WIAT) Spelling: Standard Score|The Wechsler Individual Achievement Test is an examiner administered measure of academic skills. The Spelling score assesses the child’s ability to spell words to dictation. Raw scores are converted to standard scores with a mean of 100±15 where higher scores indicate better performance. Assessments were performed prior to beginning the Home Therapy Phase (baseline) and upon completion of the phase. Phase completion ranged between 11.44 to 24.36 months|From beginning and after completion of home maintenance phase, on average 16.3 months.|118 patients began the MPH Home Maintenance Phase of the trial. 68 completed the year long phase. 68 were screened at the beginning of the trial using the Wechsler Individual Achievement Test (WIAT) Spelling: Standard Score System and 68 were screened at completion. 68 patients were analyzed.||T-score||95% Confidence Interval|Mean
753437|NCT00576472|Primary|Change From Maintenance Phase Baseline to Completion of Phase as Measured by Wechsler Individual Achievement Test (WIAT) Reading: Composite Standard Score|The Wechsler Individual Achievement Test is an examiner administered measure of academic skills. The Reading Composite consists of Basic Reading (single word reading) and Reading Comprehension. Raw scores are converted to standard scores with a mean of 100±15 where higher scores indicate better performance. Assessments were performed prior to beginning the Home Therapy Phase (baseline) and upon completion of the phase. Phase completion ranged between 11.44 to 24.36 months|From beginning and at completion of home maintenance phase, on average 16.3 months.|118 patients began the MPH Home Maintenance Phase of the trial. 68 completed the year long phase. 68 were screened at the beginning of the trial using the Wechsler Individual Achievement Test (WIAT) REading: Composite Standard Score questionnaire and 68 were screened at completion. 68 patients were analyzed.||T-score||95% Confidence Interval|Mean
753438|NCT00576472|Primary|Change From Maintenance Phase Baseline to Completion of Phase as Measured by Social Skill Rating System (SSRS-P)|The Social Skills Rating System- Parent Version (SSRS-P) is a parent rating scale of social behaviors in reference to typically developing children. Thirty eight questions are rated 0 (Never) to 3 (very often). The social skills score is norm-referenced with a mean of 100±15 where a higher score is indicative of better skills. Assessments were performed prior to beginning the Home Therapy Phase (baseline) and upon completion of the phase. Phase completion ranged between 11.44 to 24.36 months|From beginning and at completion of home maintenance phase, on average 16.3 months.|118 patients began the MPH Home Maintenance Phase of the trial. 68 completed the year long phase. 68 were screened at the beginning of the trial using the Social Skills Rating System (SSRS-P) and 68 were screened at completion. 68 patients were analyzed.||T-score||95% Confidence Interval|Mean
753439|NCT00576472|Primary|Change From Maintenance Phase Baseline to Completion of Phase as Measured by Conner's Parent Rating Scale (CPRS: Cognitive Problem T Score)|The Conners’ Teacher Rating Scale- Revised (S) is a measure of the observed frequency of behaviors associated with ADHD. Twenty-seven questions are rated on a scale from 0 (not true at all) to 3 (very much true). Raw scores are converted to T scores using age and gender normative data. T scores have a mean of 50 ± 10 where higher scores are indicative of greater problems. Assessments were performed prior to beginning the Home Therapy Phase (baseline) and upon completion of the phase. Phase completion ranged between 11.44 to 24.36 months|From beginning and at completion of home maintenance phase, on average 16.3 months.|118 patients began the MPH Home Maintenance Phase of the trial. 68 completed the year long phase. 68 were screened at the beginning of the trial using the CPRS: Cognitive Problem T Score Questionnaire and 68 were screened at completion. 68 patients were analyzed.||T-score||95% Confidence Interval|Mean
753440|NCT00576472|Primary|Change From Maintenance Phase Baseline to Completion of Phase as Measured by Conners' Parent Rating Scale (CPRS: ADHD T Score)|The Conners’ Teacher Rating Scale- Revised (S) is a measure of the observed frequency of behaviors associated with ADHD. Twenty-seven questions are rated on a scale from 0 (not true at all) to 3 (very much true). Raw scores are converted to T scores using age and gender normative data. T scores have a mean of 50 ± 10 where higher scores are indicative of greater problems. Assessments were performed prior to beginning the Home Therapy Phase (baseline) and upon completion of the phase. Phase completion ranged between 11.44 and 24.36 months.|From beginning and at completion of home maintenance phase, on average 16.3 months.|118 patients began the MPH Home Maintenance Phase of the trial. 68 completed the year long phase. 68 were screened at the beginning of the trial using the CPRS: ADHD T Score Questionnaire and 68 were screen at completion. 68 patients were analyzed.||T-score||95% Confidence Interval|Mean
753597|NCT00577460|Secondary|Number of Participants With Serious Adverse Events||80 weeks|The Treated Set (TS) included all patients who were dispensed study drug and were documented to have at least one dose of investigational treatment||Patients|||Number
753441|NCT00576472|Primary|Change From Maintenance Phase Baseline to Completion of Phase as Measured by Conners' Teacher Rating Scale (CTRS: Cognitive Problem T Score)|The Conners’ Teacher Rating Scale- Revised (S) is a measure of the observed frequency of behaviors associated with ADHD. Twenty-eight questions are rated on a scale from 0 (not true at all) to 3 (very much true). Raw scores are converted to T scores using age and gender normative data. T scores have a mean of 50 ± 10 where higher scores are indicative of greater problems. Assessments were performed prior to beginning the Home Therapy Phase (baseline) and upon completion of the phase. Phase completion ranged between 11.44 to 24.36 months|From beginning and at completion of home maintenance phase, on average 16.3 months.|118 patients began the MPH Home Maintenance Phase of the trial. 68 completed the year long phase. 55 were screened at the beginning of the trial using the CTRS: ADHD T Score Questionnaire and 59 were screened at completion. 47 patients were analyzed.||T-score||95% Confidence Interval|Mean
753442|NCT00576472|Primary|Change From Methylphenidate (MPH) Home Maintenance Phase Baseline to Completion of Phase as Measured by Conners' Teacher Rating Scale (CTRS: ADHD T Score)|The Conners’ Teacher Rating Scale- Revised (S) is a measure of the observed frequency of behaviors associated with ADHD. Twenty-eight questions are rated on a scale from 0 (not true at all) to 3 (very much true). Raw scores are converted to T scores using age and gender normative data. T scores have a mean of 50 ± 10 where higher scores are indicative of greater problems. Assessments were performed prior to beginning the Methylphenidate (MPH) Home Maintenance Phase(baseline) and upon completion of the phase. Phase completion ranged between 11.44 and 24.36 months.|From beginning and at completion of Methylphenidate (MPH) Home Maintenance Phase, on average 16.3 months.|118 patients began the MPH Home Maintenance Phase of the trial. 68 completed the year long phase. 55 were screened at the beginning of the trial using the CTRS: ADHD T Score Questionnaire and 59 were screen at completion. 47 patients were analyzed.||T-score||95% Confidence Interval|Mean
753443|NCT00576472|Primary|Brain White Matter Volume for Treatment Intensity Groups and Sibling Controls|To compare the white matter volume of patients by treatment intensity groups (mild, moderate, and high) and sibling controls using MRI results captured between -1.8 and 42.36 months from study enrollment. Existing MRIs very close to enrollment were permissable for inclusion in this study.|Enrollment to evaluation of MRI, on average 12.8 months.|Of the 505 patients enrolled, 106 did not have MRI acquired to measure brain volume, 16 were not evaluable: 6 had metal artifacts, 3 had motion artifacts, 1 had an acquisition error in MRI image, 4 had tumor on exam, and 2 had ischemic insults. 383 patients had evaluable MRI images. 67 of the 91 sibling controls had an evaluable MRI image.||percentage||95% Confidence Interval|Mean
753444|NCT00576472|Primary|Brain White Matter Volume for Patients With Acute Lymphoblastic Leukemia Versus Brain Tumors|To compare the white matter volume of Acute Lymphoblastic Leukemia (ALL) patients with those of patients with malignant brain tumors using MRI results captured between -1.8 and 42.36 months from study enrollment. Existing MRIs very close to enrollment were permissable for inclusion in this study.|Enrollment to evaluation of MRI, on average 12.8 months.|Of the 505 patients enrolled, 106 did not have MRI acquired to measure brain volume, 16 were not evaluable: 6 had metal artifacts, 3 had motion artifacts, 1 had an acquisition error in MRI image, 4 had tumor on exam, and 2 had ischemic insults. 383 patients had evaluable MRI images.||percentage||95% Confidence Interval|Mean
753445|NCT00576472|Primary|Brain White Matter Volume for Patients Versus Sibling Controls|To compare the white matter volume of patients with those of sibling controls using MRI results captured between -1.8 and 42.36 months from study enrollment. Existing MRIs very close to enrollment were permissable for inclusion in this study.|Enrollment to evaluation of MRI, on average 12.8 months.|Of the 505 patients enrolled, 106 did not have MRI acquired to measure brain volume, 16 were not evaluable: 6 had metal artifacts, 3 had motion artifacts, 1 had an acquisition error in MRI image, 4 had tumor on exam, and 2 had ischemic insults. 383 patients had evaluable MRI images. 67 of the 91 sibling controls had evaluable MRI images.||percentage||95% Confidence Interval|Mean
753446|NCT00576524|Secondary|Changes in Heart Rate and Blood Pressure Measured by a Non-invasive Cuff.||6 weeks|Data not analyzed - study closed due to lack of recruitment|||||
753447|NCT00576524|Secondary|Extra Days to Achieve Target Dry Weight|Extra number of days required for hemodialysis/ultrafiltration to achieve dry body weight|6 weeks|Data not analyzed - study closed due to lack of recruitment|||||
753448|NCT00576524|Primary|Fluid Removal|Fluid removed as percentage of dry body weight.|6 weeks|Data not analyzed - study closed due to lack of recruitment|||||
753449|NCT00576576|Secondary|Change in Fibrous Plaque Volume|Change in fibrous plaque volume between baseline and follow-up. This was derived by subtracting the baseline value from the 6-month value.|6 months|All enrolled patients with complete data set||mm^3||Inter-Quartile Range|Median
753450|NCT00576576|Secondary|Change in Atheroma Volume|Change in atheroma volume between baseline and follow-up is reported. This was derived by subtracting the baseline value from the 6-month value.|6 months|All enrolled patients with complete data set||mm^3||Inter-Quartile Range|Median
753451|NCT00576576|Primary|Change in Necrotic Core Volume|Virtual Histology-Intravascular Ultrasound (VH-IVUS) defined necrotic core cross sectional area (CSA) measured in each VH-IVUS frame and averaged over length of studied vessel at baseline and follow -up. Change in necrotic core CSA between baseline and follow-up was calculated (subtracting the baseline value from the follow-up value).|6 months|All enrolled patients with complete data set||mm^2||Standard Deviation|Mean
753452|NCT00576628|Secondary|The Number of Participants Who Required Dose Adjustments During the Efficacy Evaluation Period|The number of participants who required dose adjustments of C.E.R.A was reported during the EEP. EEP was from Week 29 to Week 36.|From Week 29 to Week 36 (EEP)|The primary analysis was performed on PP population. The PP population included all treated participants (ITT participants) except those who had less than 3 recorded Hb values during EEP or with inadequate iron status during the EEP or missed administrations of C.E.R.A. during Week 28 to Week 36.||participants|||Number
753453|NCT00576628|Secondary|Mean Values of Laboratory Parameters: Transferrin Saturation|The mean values for transferrin saturation (TSAT) for each individual participant were estimated throughout the study. Summary data of mean values of TSAT at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.|Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48|"The analysis was performed on safety population. The safety population included all the participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. The n represents the number of participants analyzed at a specified time point."||percentage of saturation||Standard Deviation|Mean
753454|NCT00576628|Secondary|Mean Values of Laboratory Parameters: White Blood Cell and Thrombocyte Count|The mean values of white blood cell (WBC) and thrombocyte count for each individual participant were estimated throughout the study. Summary data of mean values of WBC and thrombocyte count at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.|Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48|"The analysis was performed on safety population. The safety population included all the participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. The n represents the number of participants analyzed at a specified time point."||10^9 cells/liter||Standard Deviation|Mean
753455|NCT00576628|Secondary|Mean Values of Laboratory Parameter: Ferritin Concentration|The mean values of ferritin concentration for each individual participant throughout the study were estimated. Summary data of mean values of ferritin concentration at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.|Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48|"The analysis was performed on safety population. The safety population included all the participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. The n represents the number of participants analyzed at a specified time point."||micrograms per liter||Standard Deviation|Mean
753456|NCT00576628|Secondary|Mean Values of Laboratory Parameter: Albumin and Transferrin Concentration|The mean values of albumin and transferrin concentration for each individual participant throughout the study were estimated. Summary data of mean values of albumin and transferrin concentration at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.|Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48|"The analysis was performed on safety population. The safety population included all the participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. The n represents the number of participants analyzed at a specified time point."||grams per liter||Standard Deviation|Mean
753457|NCT00576628|Secondary|Mean Values of Laboratory Parameter: C Reactive Protein|The mean values of C reactive protein (CRP) for each individual participant throughout the study were estimated. Summary data of mean values of CRP at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.|Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48|The analysis was performed on safety population. The safety population included all the participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. The “n” represents the number of participants analyzed at a specified time point.||milligrams per liter||Standard Deviation|Mean
753458|NCT00576628|Secondary|Mean Values of Laboratory Parameter : Serum Creatinine|The mean values of serum creatinine for each individual participant throughout the study were estimated. Summary data of mean values of serum creatinine at Week 0 (Baseline) and Week 32 are presented.|Baseline (Week 0), and Week 32|"The analysis was performed on safety population. The safety population included all the participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. The n represents the number of participants analyzed at a specified time point."||micromoles/liter||Standard Deviation|Mean
753459|NCT00576628|Secondary|Mean Values of Laboratory Parameter : Iron and Total Iron Binding Capacity|The mean values of iron and total iron binding capacity (TIBC) for each individual participant were estimated throughout the study. Summary data of mean values of iron and TIBC at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.|Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48|"The analysis was performed on safety population. The safety population included all the participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. The n represents the number of participants analyzed at a specified time point."||micromoles/liter||Standard Deviation|Mean
753460|NCT00576628|Secondary|Mean Values of Laboratory Parameters: Potassium and Phosphate Concentration|The mean values of potassium and phosphate levels in serum for each individual participant were estimated throughout the study. Summary data of mean values of potassium and phosphate level in serum at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.|Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48|"The analysis was performed on safety population. The safety population included all the participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. The n represents the number of participants analyzed at a specified time point."||millimoles per litre||Standard Deviation|Mean
753461|NCT00576628|Secondary|Mean Values of Laboratory Parameter : Hematocrit|Hematocrit is a blood test that measures the percentage of the volume of whole blood that is made up of red blood cells (RBC). This measurement depends on the number of red blood cells and the size of red blood cells. The mean values of hematocrit for each individual participant were estimated throughout the study. Summary data of mean values of hematocrit at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.|Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48|The analysis was performed on safety population. The safety population included all the participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. The “n” represents the number of participants analyzed at a specified time point.||fraction||Standard Deviation|Mean
753462|NCT00576628|Secondary|Mean Values of Laboratory Parameter : Hb Concentration|The mean Hb concentration for each individual participant throughout the study was estimated. Summary data of mean values of Hb concentration at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.|Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48|The analysis was performed on safety population. The safety population included all the participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. The “n” represents the number of participants analyzed at a specified time point.||g/dL||Standard Deviation|Mean
753463|NCT00576628|Secondary|Number of Participants With Red Blood Cells Transfusions.|The number of participants who received at least 1 red blood cell (RBC) transfusion (packed RBC or whole blood) during the study was reported.|Up to Week 52|The analysis was performed on safety population. The safety population included all the participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not.||participants|||Number
753464|NCT00576628|Secondary|Time to Achievement of Response During the Efficacy Evaluation Period|The time to achievement of response was defined as the time when the participants achieved Hb concentration within the target range of 11.0 to 13.0 g/dL during the EEP. The EEP was from Week 29 to Week 36.|From Week 29 to Week 36|The primary analysis was performed on PP population. The PP population included all treated participants (ITT participants) except those who had less than 3 recorded Hb values during EEP or with inadequate iron status during the EEP or missed administrations of C.E.R.A. during Week 28 to Week 36.||days||Standard Deviation|Mean
753465|NCT00576628|Secondary|The Number of Participants Who Required Dose Adjustments During the Dose Titration Period|The number of participants who required dose adjustments of C.E.R.A was reported during the Dose Titration Period (DTP). The DTP was from Week 0 to Week 28.|From Week 0 to Week 28 (DTP)|The primary analysis was performed on PP population. The PP population included all treated participants (ITT participants) except those who had less than 3 recorded Hb values during EEP or with inadequate iron status during the EEP or missed administrations of C.E.R.A. during Week 28 to Week 36.||participants|||Number
753466|NCT00576628|Secondary|Mean Time Spent in Target Hb Range of 11.0 -13.0 g/dL During the Efficacy Evaluation Period|The number of days spent by participants with Hb in range of 11.30 -13.0 g/dL was calculated during the EEP and presented. The EEP comprised was from Week 29 to Week 36.|From Week 29 to Week 36|The primary analysis was performed on PP population. The PP population included all treated participants (ITT participants) except those who had less than 3 recorded Hb values during EEP or with inadequate iron status during the EEP or missed administrations of C.E.R.A. during Week 28 to Week 36.||days||Standard Deviation|Mean
753467|NCT00576628|Secondary|Percentage of Participants Maintaining Average Hb Concentration Within the Target Range of 11.0-13.0 g/dL Throughout the EEP|Percentage of participants maintaining individual Hb concentration within the range of 11.0-13.0 g/dL was reported during EEP. The EEP was from Week 29 to Week 36.|From Week 29 to Week 36|The primary analysis was performed on PP population. The PP population included all treated participants (ITT participants) except those who had less than 3 recorded Hb values during EEP or with inadequate iron status during the EEP or missed administrations of C.E.R.A. during Week 28 to Week 36.||percentage of participants||95% Confidence Interval|Number
753468|NCT00576628|Primary|Mean Change in Hb Concentration g/dL Between Baseline and the Efficacy Evaluation Period|The mean change in Hb concentration between Baseline and Efficacy Evaluation Period (EEP) was calculated by subtracting the baseline Hb concentration from the EEP Hb concentration. Each participant included in this analysis had at least 3 recorded Hb values during EEP, and these Hb values were combined using a time-adjusted average. The EEP was from Week 29 to Week 36.|Baseline (Week 0) and from Week 29 to Week 36|The primary analysis was performed on per protocol (PP) population. The PP population included all treated participants (ITT participants) except those who had less than 3 recorded Hb values during EEP or with inadequate iron status during the EEP or missed administrations of C.E.R.A. during Week 28 to Week 36.||g/dL||Standard Deviation|Mean
753469|NCT00576693|Primary|Any Stroke or Death Within 30 Days of Enrollment or Any Revascularization Procedure OR an Ischemic Stroke in the Territory of the Symptomatic Intracranial Artery Beyond 30 Days After Enrollment.|Any stroke (ischemic, parenchymal brain hemorrhage, subarachnoid or intraventricular hemorrhage) or death within 30 days after enrollment OR any stroke (ischemic, parenchymal brain hemorrhage, subarachnoid or intraventricular hemorrhage) or death within 30 days of any revascularization procedure of the qualifying symptomatic intracranial artery done during follow-up, OR an ischemic stroke in the territory of the symptomatic intracranial artery from day 31 after study entry to completion of follow-up.|Mean length of follow-up was 2.4 years|All patients enrolled in the study were included in the primary outcome analysis.||participants|||Number
753470|NCT00576732|Secondary|Change in Insulin Resistance (IR) at 6 Months|Insulin resistance calculated using the homeostatic model assessment 1 (HOMA1) formula: fasting glucose (mmol/L) times fasting insulin (uU/L) divided by 22.5. HOMA-IR is a widely used clinical tool for estimating insulin resistance based upon the balance between glucose output and insulin secretion. Normal values should be close to 1, while an increase indicates a decrease in insulin sensitivity (or increase in insulin resistance), a potential predictor for the development of Type 2 Diabetes Mellitus.|Baseline and 6 months|All subjects with at least one dose of study medication in the open label phase and both double-blind baseline and at least one open-label period fasting laboratory samples. For subjects who discontinued, Month 6 data is imputed using the subject's last nonmissing, postbaseline value in the open-label period.||units on a scale||Standard Deviation|Mean
753471|NCT00576732|Secondary|Change in Fasting Glucose (mg/dL) at 6 Months||Baseline and 6 months|All subjects with at least one dose of study medication in the open label phase and both double-blind baseline and at least one open-label period fasting laboratory samples. For subjects who discontinued, Month 6 data is imputed using the subject's last nonmissing, postbaseline value in the open-label period.||mg/dL||Standard Deviation|Mean
753472|NCT00576732|Secondary|Change in Insulin Resistance (IR) at 6 Weeks|Insulin resistance calculated using the homeostatic model assessment 1 (HOMA1)formula: fasting glucose (mmol/L) times fasting insulin (uU/L) divided by 22.5. HOMA-IR is a widely used clinical tool for estimating insulin resistance based upon the balance between glucose output and insulin secretion. Normal values should be close to 1, while an increase indicates a decrease in insulin sensitivity (or increase in insulin resistance), a potential predictor for the development of Type 2 Diabetes Mellitus.|Baseline and 6 weeks|All randomized subjects with >=1 dose of study medication and fasting glucose and insulin at baseline and at >=1 postbaseline time point. For subjects who discontinued, Week 6 data is imputed using the subject's last nonmissing, postbaseline value in the double-blind period. Means are adjusted for baseline weight (<45 kg, >=45 kg) and baseline IR.||units on a scale||95% Confidence Interval|Least Squares Mean
753473|NCT00576732|Secondary|Change in Fasting Glucose (mg/dL) at 6 Weeks||Baseline and 6 weeks|All randomized subjects with at least one dose of study medication and both baseline and at least one postbaseline fasting laboratory samples. For subjects who discontinued, Week 6 data is imputed using the subject's last nonmissing, postbaseline value in the double-blind period (Last Observation Carried Forward [LOCF]).||mg/dL||Standard Deviation|Mean
753543|NCT00577096|Primary|Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets.(Short Term)||up to 15 weeks|For the exercise group 8 participants who entered the study were not included in the analysis (2 withdrew from myeloma treatment, 1 died, 5 withdrew from study). For the usual care group 7 were not included in the analysis (3 withdrew from myeloma treatment, 1 died, 3 withdrew from study).||Platelet transfusions||Standard Deviation|Mean
753474|NCT00576732|Secondary|Number of Participants Who Had Clinical Global Impression Change Ratings of Much or Very Much Improved.|"Investigator impression of change over time from double-blind baseline on a 7-point scale (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse)."|6 weeks|All randomized subjects with at least one dose of study medication and at least one postbaseline value. For subjects who discontinued, Week 6 data is imputed using the subject's last nonmissing, postbaseline value in the double-blind period (Last Observation Carried Forward [LOCF]).||participants|||Number
753475|NCT00576732|Secondary|Change in Clinical Global Impression Severity (CGI-S)|"Investigator evaluation of severity of illness and functional impairment on a 7-point scale (1=not ill, 2=very mild, 3=mild, 4=moderate, 5=marked, 6=severe, 7=extremely severe)."|Baseline and 6 weeks|All randomized subjects with at least one dose of study medication and both baseline and at least one postbaseline value. For subjects who discontinued, Week 6 data is imputed using the subject's last nonmissing, postbaseline value in the double-blind period (Last Observation Carried Forward [LOCF]).||units on a scale||Standard Deviation|Mean
753476|NCT00576732|Secondary|Number of Participants Who Had at Least 25% Improvement in ABC-I|ABC-I is a measure of irritability symptoms of autism with score range 0 to 45 (lower score = lesser severity).|6 weeks|All randomized subjects with at least one dose of study medication and both baseline and at least one postbaseline value. For subjects who discontinued, Week 6 data is imputed using the subject's last nonmissing, postbaseline value in the double-blind period (Last Observation Carried Forward [LOCF]).||participants|||Number
753477|NCT00576732|Primary|Change in Aberrant Behavior Checklist Irritability (ABC-I) Subscale|Measure of irritability symptoms of autism. Score range 0 to 45 (lower score = lesser severity).|Baseline and 6 weeks|All randomized subjects with at least one dose of study medication and both baseline and at least one postbaseline value. For subjects who discontinued, Week 6 data is imputed using the subject's last nonmissing, postbaseline value in the double-blind period (Last Observation Carried Forward [LOCF]).||units on a scale||Standard Deviation|Mean
753478|NCT00576758|Secondary|Number of Participants With Human Anti-Human Antibodies (HAHA)|Blood was collected on Day 1 pre-infusion, during the safety follow-up for those patients who did not enter the Extension period and 6 months after the last infusion of the Extension Period if applicable. Blood was sent to a central laboratory and was tested for anti-obinutuzumab antibodies using a validated enzyme-linked immunosorbent assay (ELISA). HAHA samples were not collected for participants randomized to the rituximab arm.|Randomization to Clinical cutoff: 07 March 2013 (Up to 43.2 months)|Safety Population included all randomized participants who received study drug.||Participants|||Number
753479|NCT00576758|Secondary|Number of Participants With Human Anti-Chimeric Antibodies (HACA)|Blood was collected on Day 1 and was sent to a central laboratory for analysis of human anti-chimeric antibodies (anti-rituximab antibodies) using a validated enzyme-linked immunosorbent assay (ELISA). HACA samples were not collected for participants randomized to the rituximab arm.|Day 1|Participants from the Safety Population, all randomized participants who received study drug, who had samples available for HACA analysis.||Participants|||Number
753480|NCT00576758|Secondary|Number of Participants With Infusion Related Reactions|Infusion Related Reactions were AEs that occurred during the infusion or within 24 hours of the infusion.|Randomization to Clinical cutoff: 07 March 2013 (Up to 43.2 months)|Safety Population included all randomized participants who received at least once dose of study drug.||Participants|||Number
753481|NCT00576758|Secondary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory result), symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. A SAE was any AE that was one of the following: fatal, life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the investigational product or considered a significant medical event by the investigator. Additional information about AEs can be found in the Adverse Event Section.|Randomization to Clinical cutoff: 07 March 2013 (Up to 43.2 months) [Includes all AEs reported 28 days after last dose and all Related SAEs regardless of time of last dose.]|Safety Population included all randomized participants who received study drug.||Participants|||Number
753482|NCT00576758|Secondary|Number of Participants With Peripheral Blood B-Cell Recovery|Blood was sent to a central laboratory for the evaluation of cluster of differentiation 19 (CD19) by flow cytometry. B-cell recovery was defined as the time point when the CD-19 values return to ≥ 50% of baseline levels. The number of participants with B-cell recovery from End of Induction (treatment) Phase to 6 months of Follow-up is reported in two categories: Recovery with Progressive Disease (PD) or Recovery without PD. PD required one of the following: 50 % increase in the absolute number of circulating lymphocytes, Appearance of new palpable lymph nodes, 50 % increase in the longest diameter of any previous site of lymphadenopathy, 50 % increase in the enlargement of the liver and/or spleen or Transformation to a more aggressive histology.|End of last dose + 6 Months Follow-Up|Participants from the Safety Population, all randomized participants who received study drug, with previous B-Cell Depletion and B-Cell assessment at 6 Month Follow-up.||Participants|||Number
753483|NCT00576758|Secondary|Number of Participants With Peripheral Blood B-Cell Depletion|Blood was collected and sent to a central laboratory for the evaluation of cluster of differentiation 19 (CD19) by flow cytometry at the end of the induction period. B-cell depletion was defined as a CD19 result 5 % of the Baseline value after at least one dose of study drug was administered.|Day 22|Participants from the Safety Population, all randomized participants who received study drug, with data available for analysis.||Participants|||Number
753484|NCT00576758|Secondary|Obinutuzumab Trough Serum Concentration (Ctrough)|Blood was collected for PK Parameters before and after dose administration of obinutuzumab in Induction Phase Cycles 2, 3 and 4. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA). Ctrough was calculated in micrograms/milliliter (μg/mL).|Days 8 and 15 (pre-infusion, at end of infusion), Day 22 (pre-infusion, at end of infusion, 3-6, 20-28, 66-80 hours, 6-8, 12-16, 18-24, 28-56 days post-infusion)|PK Analysis Population included all participants who received obinutuzumab and had PK samples collected as per protocol. Patients with limited PK sampling time-points were excluded from the analysis.||μg/mL||Standard Deviation|Mean
770022|NCT00715793|Secondary|6-month Progression-free Survival (PFS) Rate||6 months|Patients that either progressed or died by 6 months.||percentage of participants|||Number
753485|NCT00576758|Secondary|Obinutuzumab Serum PK Parameter: Area Under the Concentration Curve Between Dosing Interval (AUCtau)|Blood was collected for PK Parameters before and after dose administration of obinutuzumab in Induction Phase Cycle 4. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA). AUCtau was calculated in days* micrograms/milliliter (μg/mL)|Day 22 (pre-infusion, at end of infusion, 3-6, 20-28, 66-80 hours, 6-8, 12-16, 18-24, 28-56 days post-infusion)|PK Analysis Population included all participants who received obinutuzumab and had PK samples collected as per protocol. Patients with limited PK sampling time-points were excluded from the analysis.||day*μg/mL||Standard Deviation|Mean
753486|NCT00576758|Secondary|Obinutuzumab Serum PK Parameter: Volume of Distribution at Steady-State (Vss)|Blood was collected for PK Parameters before and after dose administration of obinutuzumab in Induction Phase Cycle 4. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA). Vss was calculated in liters (L).|Day 22 (pre-infusion, at end of infusion, 3-6, 20-28, 66-80 hours, 6-8, 12-16, 18-24, 28-56 days post-infusion)|PK Analysis Population included all participants who received obinutuzumab and had PK samples collected as per protocol. Patients with limited PK sampling time-points were excluded from the analysis.||Liter||Standard Deviation|Mean
753487|NCT00576758|Secondary|Obinutuzumab Serum PK Parameter: Clearance at Steady-State (CLss)|Blood was collected for PK Parameters before and after dose administration of obinutuzumab in Induction Phase Cycle 4. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA). CLsst was calculated in milliliter/day (mL/day)|Day 22 (pre-infusion, at end of infusion, 3-6, 20-28, 66-80 hours, 6-8, 12-16, 18-24, 28-56 days post-infusion)|PK Analysis Population included all participants who received obinutuzumab and had PK samples collected as per protocol. Patients with limited PK sampling time-points were excluded from the analysis.||mL/day||Standard Deviation|Mean
753488|NCT00576758|Secondary|Obinutuzumab Serum PK Parameter: Area Under the Concentration Curve (AUClast)|Blood was collected for PK Parameters before and after dose administration of obinutuzumab in Induction Phase Cycle 4. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA). AUClast was calculated in days* micrograms/milliliter (μg/mL)|Day 22 (pre-infusion, at end of infusion, 3-6, 20-28, 66-80 hours, 6-8, 12-16, 18-24, 28-56 days post-infusion)|PK Analysis Population included all participants who received obinutuzumab and had PK samples collected as per protocol. Patients with limited PK sampling time-points were excluded from the analysis.||day*μg/mL||Standard Deviation|Mean
753489|NCT00576758|Secondary|Obinutuzumab Serum PK Parameter: Maximum Serum Concentration (Cmax)|Blood was collected for PK Parameters before and after dose administration of obinutuzumab in Induction Phase Cycles 1, 2, 3 and 4. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA). Cmax was calculated in micrograms/milliliter (μg/mL).|Day 1 (pre-infusion, at end of infusion, 3-6, 20-28, 66-80 hours post-infusion), Days 8 and 15 (pre-infusion, at end of infusion), Day 22 (pre-infusion, at end of infusion, 3-6, 20-28, 66-80 hours, 6-8, 12-16, 18-24, 28-56 days post-infusion)|PK Analysis Population included all participants who received obinutuzumab and had PK samples collected as per protocol. Patients with limited PK sampling time-points were excluded from the analysis.||μg/mL||Standard Deviation|Mean
753490|NCT00576758|Secondary|Obinutuzumab Serum PK Parameter: Terminal Half-Life (t1/2)|Blood was collected for Pharmacokinetic (PK) Parameters before and after dose administration of obinutuzumab in Induction Phase Cycle 4. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA). Terminal Half-Life was calculated in days.|Day 22 (pre-infusion, at end of infusion, 3-6, 20-28, 66-80 hours, 6-8, 12-16, 18-24, 28-56 days post-infusion)|PK Analysis Population included all participants who received obinutuzumab and had PK samples collected as per protocol. Patients with limited PK sampling time-points were excluded from the analysis.||days||Standard Deviation|Mean
753491|NCT00576758|Secondary|Duration of Response|"Duration of Response was defined as the date the response, either Complete Response (CR) or Partial Response (PR), was first recorded until the date of Disease Progression or death due to any cause. Computed tomography imaging was used for the primary assessment of tumor response per 1999 criteria by Cheson.
CR was defined as the disappearance of all clinical and radiographic evidence of disease, disease-related symptoms and normalization of biochemical abnormalities of NHL.
PR was defined as 50% decrease in SPD of the 6 largest dominant nodes or nodal masses. No increase in the size of the other nodes, liver, or spleen. Splenic and hepatic nodules must regress by at least 50% in the SPD. No new sites of disease.
Disease Progression was defined as a ≥ 50% increase from nadir in the SPD of any previously identified abnormal node and/or the appearance of any new lesion during or at the end of therapy."|Randomization to Clinical cutoff: 07 March 2013 (Up to 43.2 months)|Participants from the ITT population (all randomized participants with follicular NHL at the time of diagnosis N=75/74] with response. Patients with no documented progression after CR or PR will be censored at the last tumor assessment. If no assessment available patients will be censored at the first study drug.||Months||95% Confidence Interval|Median
753492|NCT00576758|Secondary|Percentage of Participants With Event Free Survival (EFS) Events|"Percentage of participants with Event Free Events: disease progression/relapse, death, or start of a new anti-leukemic therapy.
Progression was defined as a ≥ 50% increase from nadir in the SPD of any previously identified abnormal node and/or the appearance of any new lesion during or at the end of therapy.
Relapse was defined as the appearance of any new lesion or increase by ≥ 50% in the size of previously involved sites and/or a ≥ 50% increase in greatest diameter of any previously identified node greater than 1 cm in its short axis or in the SPD of more than one node."|Randomization to Clinical cutoff: 07 March 2013 (Up to 43.2 months)|Participants from the Intent-to-treat (ITT) population (all randomized participants) with follicular non-Hodgkin's lymphoma (NHL) at the time of diagnosis.||Percentage of participants|||Number
753536|NCT00577096|Secondary|Hemoglobin Levels Before Chemotherapy and During Transplantation Period (Long Term)|Hemoglobin Levels were measured at baseline, before peripheral blood stem cell transplantation (PBSCT), during PBSCT and at hospital discharge.|up to 30 weeks|For the exercise group 8 participants who entered the study were not included in the analysis (2 withdrew from myeloma treatment, 1 died, 5 withdrew from study). For the usual care group 7 were not included in the analysis (3 withdrew from myeloma treatment, 1 died, 3 withdrew from study).||g/dl||Standard Deviation|Mean
753493|NCT00576758|Secondary|Event Free Survival|"Event-free survival (EFS) was defined as the time between date of randomization and the date of disease progression/relapse, death, or start of a new anti-leukemic therapy.
Progression was defined as a ≥ 50% increase from nadir in the SPD of any previously identified abnormal node and/or the appearance of any new lesion during or at the end of therapy.
Relapse was defined as the appearance of any new lesion or increase by ≥ 50% in the size of previously involved sites and/or a ≥ 50% increase in greatest diameter of any previously identified node greater than 1 cm in its short axis or in the SPD of more than one node."|Randomization to Clinical cutoff: 07 March 2013 (Up to 43.2 months)|ITT population included all randomized participants with follicular non-Hodgkin's lymphoma at the time of diagnosis. If no EFS event occurred, EFS was censored at the date of the last tumor assessment. If no tumor assessment is available patient was censored at the date of the first study drug administration.||Days||95% Confidence Interval|Median
753494|NCT00576758|Secondary|Percentage of Participants With Progression-Free Survival (PFS) Events|"The percentage of participants with progression, relapse, or death events from any cause as assessed by the Investigator.
Progression was defined as a ≥ 50% increase from nadir in the SPD of any previously identified abnormal node and/or the appearance of any new lesion during or at the end of therapy.
Relapse was defined as the appearance of any new lesion or increase by ≥ 50% in the size of previously involved sites and/or a ≥ 50% increase in greatest diameter of any previously identified node greater than 1 cm in its short axis or in the SPD of more than one node."|Randomization to Clinical cutoff: 07 March 2013 (Up to 43.2 months)|Participants from the ITT population (all randomized participants) with follicular non-Hodgkin's lymphoma at the time of diagnosis. If event did not occur, PFS was censored at the date of the last tumor assessment. If no tumor assessment is available patient was censored at the date of the first study drug administration.||Percentage of participants|||Number
753495|NCT00576758|Secondary|Progression-Free Survival (PFS)|"PFS was defined as the time from randomization to the first occurrence of progression, relapse, or death from any cause as assessed by the Investigator.
Progression was defined as a ≥ 50% increase from nadir in the SPD of any previously identified abnormal node and/or the appearance of any new lesion during or at the end of therapy.
Relapse was defined as the appearance of any new lesion or increase by ≥ 50% in the size of previously involved sites and/or a ≥ 50% increase in greatest diameter of any previously identified node greater than 1 cm in its short axis or in the SPD of more than one node."|Randomization to Clinical cutoff: 07 March 2013 (Up to 43.2 months)|ITT population included all randomized participants with follicular non-Hodgkin's lymphoma at the time of diagnosis. If no PFS even occurred, PFS was censored at the date of the last tumor assessment. If no tumor assessment was available patient was censored at the date of the first study drug administration.||Days||95% Confidence Interval|Median
753496|NCT00576758|Secondary|Percentage of Participants With Best Overall Response Achieved at Any Time During the Study Treatment|"Overall response was defined as Complete Response (CR), Complete Response/Unconfirmed (CRu) or Partial Response (PR) as assessed by investigators during study treatment (induction or extended treatment phase). Computed tomography imaging was used for the primary assessment of tumor response per 1999 criteria by Cheson.
CR was defined as the disappearance of all clinical and radiographic evidence of disease, disease-related symptoms and normalization of biochemical abnormalities of NHL.
CRu was CR plus one or more of the following: A residual lymph node mass greater than 1.5 cm in greatest transverse diameter that has regressed by more than 75% in the sum of the products of the greatest diameter (tumors)(SPD) and/or indeterminate bone marrow.
PR was defined as 50% decrease in SPD of the 6 largest dominant nodes or nodal masses. No increase in the size of the other nodes, liver, or spleen. Splenic and hepatic nodules must regress by at least 50% in the SPD. No new sites of disease."|Randomization to Clinical cutoff: 07 March 2013 (Up to 43.2 months)|Participants from the Intent-to-treat (ITT) population (all randomized participants) with follicular non-Hodgkin's lymphoma (NHL) at the time of diagnosis.||Percentage of participants||95% Confidence Interval|Number
753497|NCT00576758|Secondary|Number of Participants With Improved Overall Response During the Extended Treatment Period|Overall response was defined as Complete Response (CR), Complete Response/Unconfirmed (CRu) or Partial Response (PR) as assessed by investigators at end of induction treatment. Computed tomography imaging was used for the primary assessment of tumor response per 1999 criteria by Cheson.|Randomization to Clinical cutoff: 07 March 2013 (Up to 43.2 months)|Participants from the Intent-to-treat (ITT) population (all randomized participants) with follicular non-Hodgkin's lymphoma (NHL) at the time of diagnosis who received treatment in the extension period.||Participants|||Number
753498|NCT00576758|Secondary|Percentage of Participants With Best Overall Response Achieved at Any Time During the Study Treatment|"Overall response was defined as Complete Response (CR), Complete Response/Unconfirmed (CRu) or Partial Response (PR) as assessed by investigators during study treatment (induction or extended treatment phase). Computed tomography imaging was used for the primary assessment of tumor response per 1999 criteria by Cheson.
CR was defined as the disappearance of all clinical and radiographic evidence of disease, disease-related symptoms and normalization of biochemical abnormalities of NHL.
CRu was CR plus one or more of the following: A residual lymph node mass greater than 1.5 cm in greatest transverse diameter that has regressed by more than 75% in the sum of the products of the greatest diameter (tumors)(SPD) and/or indeterminate bone marrow.
PR was defined as 50% decrease in SPD of the 6 largest dominant nodes or nodal masses. No increase in the size of the other nodes, liver, or spleen. Splenic and hepatic nodules must regress by at least 50% in the SPD. No new sites of disease."|Randomization to clinical cutoff : 01 September 2011 (Up to 70 days)|Participants from the Intent-to-treat (ITT) population (all randomized participants) with follicular non-Hodgkin's lymphoma (NHL) at the time of diagnosis.||Percentage of participants||95% Confidence Interval|Number
753499|NCT00576758|Secondary|Percentage of Participants With Partial Response (PR) at the End of the Induction Period|Computed tomography imaging was used for the primary assessment of tumor response per 1999 criteria by Cheson. PR was defined as 50% decrease in SPD of the 6 largest dominant nodes or nodal masses. No increase in the size of the other nodes, liver, or spleen. Splenic and hepatic nodules must regress by at least 50% in the SPD. No new sites of disease.|Randomization to clinical cutoff : 01 September 2011 (Up to 70 days)|Participants from the Intent-to-treat (ITT) population (all randomized participants) with follicular non-Hodgkin's lymphoma (NHL) at the time of diagnosis.||Percentage of participants||95% Confidence Interval|Number
755313|NCT00593606|Primary|Change in Blood Urea Nitrogen|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||mmol/l||Standard Deviation|Mean
753500|NCT00576758|Secondary|Percentage of Participants With Complete Response at the End of the Induction Period|Computed tomography imaging was used for the primary assessment of tumor response per 1999 criteria by Cheson. CR is defined as the disappearance of all clinical and radiographic evidence of disease, disease-related symptoms and normalization of biochemical abnormalities of NHL. All lymph nodes and nodal masses must have regressed to normal size. The spleen, if considered to be enlarged before therapy on the basis of a CT scan, must have regressed in size and must not be palpable on physical examination. Any macroscopic nodules in any organs detectable on imaging techniques should no longer be present. Other organs considered to be enlarged before therapy due to involvement by lymphoma, such as liver and kidneys, must have decreased in size. If the bone marrow was involved by lymphoma before treatment, the infiltrate must be cleared on repeat bone marrow aspirate and biopsy of the same site.|Randomization to clinical cutoff : 01 September 2011 (Up to 70 days)|Participants from the Intent-to-treat (ITT) population (all randomized participants) with follicular non-Hodgkin's lymphoma (NHL) at the time of diagnosis.||Percentage of participants||95% Confidence Interval|Number
753501|NCT00576758|Primary|Percentage of Participants With Overall Response At the End of Induction Period|"Overall response was defined as Complete Response (CR), Complete Response/Unconfirmed (CRu) or Partial Response (PR) as assessed by investigator at end of induction treatment. Computed tomography imaging was used for the primary assessment of tumor response per 1999 criteria by Cheson.
CR was defined as the disappearance of all clinical and radiographic evidence of disease, disease-related symptoms and normalization of biochemical abnormalities of NHL.
CRu was CR plus one or more of the following: A residual lymph node mass greater than 1.5 cm in greatest transverse diameter that has regressed by more than 75% in the sum of the products of the greatest diameter (tumors)(SPD) and/or indeterminate bone marrow.
PR was defined as 50% decrease in SPD of the 6 largest dominant nodes or nodal masses. No increase in the size of the other nodes, liver, or spleen. Splenic and hepatic nodules must regress by at least 50% in the SPD. No new sites of disease."|Randomization to clinical cutoff: 01 September 2011 (Up to 70 days)|Participants from the Intent-to-treat (ITT) population (all randomized participants) with follicular non-Hodgkin's lymphoma (NHL) at the time of diagnosis.||Percentage of participants|||Number
753502|NCT00576823|Secondary|Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes||52 weeks (efficacy and extension study phases)|The analysis was performed on the exposed population (i.e. all patients who received at least one dose of Alfuzosin regardless of the amount of treatment received).||participants|||Number
753503|NCT00576823|Secondary|Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes|"When a patient presented with symptoms such as pain, fever or hematuria (discretion of the Investigator), an urinalysis was performed including a dipstick and a quantitative urine culture.
A symptomatic UTI was defined as the presence of symptoms and a positive culture with > 100 000 Colony Forming Units (CFUs) with a single organism."|12 weeks (efficacy study phase)|The analysis was performed on the ITT population (i.e. all included patients who received at least one dose of Alfuzosin).||participants|||Number
753504|NCT00576823|Primary|Number of Participants With a Decrease From Baseline ≥ 1 in the Society of Fetal Urology (SFU) Grade of Hydronephrosis|"Hydronephrosis was investigated by ultrasound and graded using SFU classification at each time point.
'Complete response' was assessed when bilateral hydronephrosis at baseline and grade decrease from baseline ≥ 1 for both kidneys, or, unilateral hydronephrosis at baseline and grade decrease from baseline ≥ 1 for the affected kidney without worsening of the other kidney.
'Partial response' was assessed when bilateral hydronephrosis at baseline and grade decrease from baseline ≥ 1 for one kidney without worsening of the other kidney."|baseline and 12 weeks (efficacy study phase)|The analysis was on the intent-to-treat (ITT) population (i.e. all included patients who received at least one dose of Alfuzosin) excluding the patients who didn't have baseline SFU grade. Patients without post-baseline SFU grade before Week 12 were included as non-responders.||participants|||Number
753505|NCT00576901|Secondary|Percentage of Participants Undergoing Breast-Conserving Surgery|The percentage of participants who were able to undergo breast-conserving surgical procedures (segmentectomy plus lymphadenectomy or quadrantectomy plus lymphadenectomy) rather than non-breast conserving procedures (radical mastectomy or modified-radical mastectomy) following 4 or more treatment cycles.|Following Cycle 6|ITT population.||percentage of participants|||Number
753506|NCT00576901|Secondary|Overall Survival|Overall survival was defined as the time from the date of informed consent until the date of death due to any cause.|Cycles 1-6|The application of a statistical model for the analysis of disease-free survival is not feasible as the sample size required for statistical analysis could not be recruited within the time established in the protocol and the study was terminated.|||||
753507|NCT00576901|Secondary|Progression-Free Survival|Progression-free survival was defined as the time from the date of informed consent until the date disease progression was identified, or the date of death from disease progression, whichever occurred first.|Cycles 1-6|The application of a statistical model for the analysis of disease-free survival was not feasible as the sample size required for statistical analysis could not be recruited within the time established in the protocol and the study was terminated.|||||
753508|NCT00576901|Secondary|Percentage of Participants Achieving an Overall Response of Complete Response (CR) or Partial Response (PR)|The percentage of participants with a best overall response of CR or PR according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal (short axis less than [<]10 millimeters [mm]). No new lesions. PR was defined as greater than or equal to (≥) 30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short aixs was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.|Day 1 of Cycles 1-6|ER population||percentage of participants|||Number
753537|NCT00577096|Secondary|Hemoglobin Levels Before Chemotherapy and During Transplantation Period (Short Term)|Hemoglobin Levels were measured at baseline, before peripheral blood stem cell transplantation (PBSCT), During PBSCT and at hospital discharge.|up to 15 weeks|For the exercise group 8 participants who entered the study were not included in the analysis (2 withdrew from myeloma treatment, 1 died, 5 withdrew from study). For the usual care group 7 were not included in the analysis (3 withdrew from myeloma treatment, 1 died, 3 withdrew from study).||g/dl||Standard Deviation|Mean
753509|NCT00576901|Primary|Percentage of Participants Achieving Pathological Complete Response (pCR)|pCR was defined as the absence of viable tumor cells, as determined by standard histologic procedure, in the tumor specimen (including regional lymph nodes) obtained at surgery. In order to minimize evaluation bias, tumor specimens were analyzed by both a central and local pathologist. The number of participants with pathological tumor stage 0 (pT0) and regional lymph nodes stage 0 (pN0) at surgery was determined. pCR was defined as the number of participants with pT0 and pN0 at surgery divided by the total number of participants with pathological tumor stage data collected.|At time of surgery, after receiving up to 6 cycles of treatment (average of 12 to 18 weeks)|Evaluable Response (ER) Population: study-eligible participants who completed at least 2 treatment cycles; had lesions evaluated using the same technique at baseline and at least once after receiving the second treatment cycle; and had no major protocol deviation.||percentage of participants|||Number
753510|NCT00576927|Other Pre-specified|Daytime Sleep|As measured by percent of daytime behavioral observations observed asleep|All Assessment Phases, up to one week|||percentage of daytime sleep observations||Standard Deviation|Mean
753511|NCT00576927|Secondary|Daytime Engagement Status|Trained research technicians observed the subjects behavior during assessment phases every 15 minutes for one full minute. Specific behavioral definitions were employed to record whether the subject was in or out of bed, awake or asleep (eyes closed with no purposeful movement for at least 60 consecutive seconds), actively engaged in an activity (reading, watching television, conversation, a specific group activity, etc), and whether any physical or verbal agitation was noted.|All Assessment Phases, up to one week|||percentage of engaged observations||Standard Deviation|Mean
753512|NCT00576927|Primary|Number of Participants Meeting Good Sleep Latency Criteria|"Sleep Latency Criteria for Good Latency measured by behavioral observations conducted every 10-15 minutes after 4pm until 11pm.
Good latency is described as subject asleep in under 20 minutes on 51% of the nights observed in a week."|All assessment periods, up to one week|30 subjects enrolled into the behavioral intervention. 4 subjects responded to the sleep hygiene intervention (SHI) arm and completed the study. 3 subjects were excluded for various reasons from the SHI arm. 23 subjects continued onto the placebo/SHI. 1 subject withdrew from that arm. From there,11 subjects received drug and 11 remained on placebo||participants|||Number
753513|NCT00576927|Secondary|Sleep Efficiency|% of time asleep holding time in bed constant (averaged over 3-5 nights)|All Assessment Phases, up to one week|Per protocol -- intention to treat - ITT - last carried forward.||percentage of sleep||Standard Deviation|Mean
753514|NCT00577005|Secondary|Cocaine Craving|Weekly cocaine craving was measure at intake and weekly after with the Visual Analog Scale (VAS) of the Cocaine Selective Severity Assessment. The VAS measures the intensity of cocaine craving with a scale from 0 (No desire at all) to 7 (Unable to resist), and frequency of cocaine craving in the previous 24 hours with a scale from 0 ( never) to 7 ( all the time). The scale is totaled for a maximum number of 14, the minimum is 0. (Kampman et al., 1998; Mulvaney et al., 1999).|Weekly from baseline to week 12|Intent to treat sample||units on a scale||Standard Error|Mean
753515|NCT00577005|Secondary|Treatment Retention|Weekly from week 1 to 13|Week 13|Intent-treat-sample (ITT) that was inducted onto methadone and received one dose of study medication on week 2.||participants|||Number
753516|NCT00577005|Secondary|Change of Thrice Weekly Opioid Free Urine Toxicology From Week 1 to 13|The secondary outcome variable was the change from baseline to week 13 of the thrice weekly opioid-free urine scores. In this repeated ordinal variable, 0 represented all 3 urines samples submitted by the subject as positives, 1 represented some urine samples submitted by the subject were negative, and 2 represented all 3 urines samples submitted by the subjects were negative for opioids excluding methadone. Balancing the distribution between these categories improved the models for the analysis of repeated ordinal data. Data summarized by number of participants who were had opioid free urine samples (score 2) per week by group.|Weekly from baseline to week 12|The intent-to-treat (ITT) sample were the 28 subjects were randomized and received one dose of study medication.||participants with opioid free urine|||Number
753517|NCT00577005|Primary|Change of Thrice Weekly Cocaine Free Urine Toxicology From Week 1 to 13|The primary outcome variable was the change from baseline to week 13 of the thrice weekly cocaine-free urine scores. In this repeated ordinal variable, 0 represented all 3 urine samples submitted by the subject as positives, 1 represented some urine samples submitted by the subject were negative, and 2 represented all 3 urine samples submitted by the subjects were negative for cocaine. Balancing the distribution between these categories improved the models for the analysis of repeated ordinal data. Data is summarized as number of participant that were cocaine free urine (score 2) per week by group.|Weekly from baseline to week 12|The intent-to-treat (ITT) sample were the 28 subjects were randomized and received one dose of study medication.||participants that were cocaine free|||Number
753518|NCT00577031|Secondary|European Quality of Life 5 Dimension (EQ-5D) Raw-Index Score|"Quality of life (QoL) assessments were used to derive pre-specified QoL scores according to the QoL manual “EQ-5D-3 Level (3L) user guide for instrument version 4.0. The EQ-5D is a participant rated questionnaire to assess health-related quality of life in terms of a single index value. The visual analog scale (VAS) component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. The overall health score absolute changes were calculated for each participant as follows: (score at the end of treatment minus score at baseline). EQ-5D health states were converted into EQ-5D-3L raw index value by applying the scoring algorithm based on the European EQ-net VAS set. The raw index was chosen instead of rescaled index, since the questionnaire was used in order to obtain a quality of life assessment. The raw index scores ranged from 0 (worst health state) to 100 (best health state)."|Baseline, every 9 weeks (every 3 cycles), at end-of-treatment up to 5 years|ITT population, only participants who had EQ-5D-3L scores for both baseline and last visit were included in the analysis.||units on a scale||Standard Deviation|Mean
753538|NCT00577096|Primary|Total Number of Days of Stem Cell Collection (Long Term)||up to 30 weeks|For the exercise group 8 participants who entered the study were not included in the analysis (2 withdrew from myeloma treatment, 1 died, 5 withdrew from study). For the usual care group 7 were not included in the analysis (3 withdrew from myeloma treatment, 1 died, 3 withdrew from study).||Days||Standard Deviation|Mean
753560|NCT00577135|Secondary|Change in Uric Acid||baseline and 72 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.||mg/dL||Standard Deviation|Mean
753519|NCT00577031|Secondary|Percentage of Participants With Best Overall Response of CR or PR by Kirsten Rat Sarcoma Viral Oncogene Homolog (K-Ras)/V-Raf Murine Sarcoma Viral Oncogene Homolog B (B-Raf) Mutation Status|"The percentage of participants with a best overall response of CR or PR according to RECIST. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal (short axis <10 mm). No new lesions. PR was defined as ≥30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.
The K-Ras and/or the B-Raf gene mutation status of participants was evaluated by the central laboratory using tumor samples. Wild-type participants did not have a mutation in either gene."|Baseline, every 9 weeks (every 3 cycles) until end of treatment, disease progression, or withdrawal up to 5 years|ITT population; only participants with a known K-Ras and/or B-Raf gene mutation status and at least 1 post-baseline tumor assessment. Number (n) equals (=) number of participants with either wild-type or K-Ras/B-Raf gene mutation.||percentage of participants|||Number
753520|NCT00577031|Secondary|Percentage of Participants Undergoing Surgical Intervention With Residual Disease Status Post-surgery|The percentage of participants who underwent surgery during the study period with an evaluation of their disease status after surgery. The surgery during the study period was described by reason: curative, palliative, biopsy, other, or unknown. Residual disease status after surgery was described as: no residual disease due to radical surgery, presence of residual disease, unknown or not applicable.|At surgery, at least 6 to 8 weeks after last dose of bevacizumab up to 5 years|The 52 participant subpopulation of the ITT population who underwent surgery during the time period of the study.||percentage of participants|||Number
753521|NCT00577031|Secondary|Overall Survival: Time to Event|Overall survival was defined as the time from the date of the first day of treatment until the date of death from any cause. If a participant was not known to have died, survival was censored at the last date the participant was known to be alive. Median overall survival was estimated using the Kaplan-Meier method.|Baseline, Day 1 of every cycle to end-of-treatment, every 3 months during longer-term follow-up, or to death due to any cause up to 5 years|ITT population.||months||95% Confidence Interval|Median
753522|NCT00577031|Secondary|Overall Survival: Percentage of Participants That Died Due to Any Cause|Overall survival was defined as the time from the date of the first day of treatment until the date of death from any cause. If a participant was not known to have died, survival was censored at the last date the participant was known to be alive.|Baseline, Day 1 of every cycle to end-of-treatment, every 3 months during longer-term follow-up, or to death due to any cause up to 5 years|ITT population.||percentage of participants|||Number
753523|NCT00577031|Secondary|Time to Treatment Failure|Time to treatment-failure was defined as the time from the first day of treatment to discontinuation of treatment for any reason, including: death due to any cause, adverse event, insufficient therapeutic response (progression of disease), failure to return (lost to follow-up), refusing treatment (participant non-compliance), being unwilling to cooperate and withdrawing consent (participant withdrew consent). For participants who did not experience a qualifying event, their data were censored at the earlier of either the date of last tumour assessment or the date of the last intake of study medication. Median time to treatment-failure was estimated using the Kaplan-Meier method.|Baseline, every 3 weeks (every cycle) to disease progression or death up to 5 years|ITT population.||months||95% Confidence Interval|Median
753524|NCT00577031|Secondary|Percentage of Participants With Treatment Failure|Treatment-failure was defined as discontinuation of treatment for any reason, including the following qualifying events: death due to any cause, adverse event, insufficient therapeutic response (progression of disease), failure to return (lost to follow-up), refusing treatment (participant non-compliance), being unwilling to cooperate and withdrawing consent (participant withdrew consent).|Baseline, every 3 weeks (every cycle) to disease progression or death up to 5 years|ITT population.||percentage of participants|||Number
753525|NCT00577031|Secondary|Duration of Stable Response|For participants with a best overall response of CR, PR, or SD during first line treatment, the duration of stable response was measured from the time that the criteria for CR, PR, or SD (whichever occurred first) was met until the first date that progressive disease was objectively documented or until the date of death due to underlying cancer, whichever occurred first. Data for participants who did not have an event or who were alive without an objectively documented progressive disease were censored at the date of last adequate tumor assessment. Median duration of stable response was estimated using the Kaplan-Meier method.|Baseline, every 3 weeks (every cycle) to disease progression or death up to 5 years|ITT population, only participants who achieved a best overall response of CR, PR, or SD during first line treatment were included in the analysis.||months||95% Confidence Interval|Median
753526|NCT00577031|Secondary|Percentage of Participants With a Stable Response During First Line Treatment|Stable response defined as participants with a best overall response of CR, PR, or stable disease (SD), defined using RECIST v1.0 criteria. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal (short axis <10 mm). No new lesions. PR was defined as a ≥30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. SD defined as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started.|Baseline, every 3 weeks (every cycle) to disease progression or death up to 5 years|ITT population, only participants who achieved a best overall response of CR, PR, or SD during first line treatment were included in the analysis.||percentage of participants|||Number
753539|NCT00577096|Primary|Total Number of Days of Stem Cell Collection (Short Term)||up to 15 weeks|For the exercise group 8 participants who entered the study were not included in the analysis (2 withdrew from myeloma treatment, 1 died, 5 withdrew from study). For the usual care group 7 were not included in the analysis (3 withdrew from myeloma treatment, 1 died, 3 withdrew from study).||Days||Standard Deviation|Mean
753561|NCT00577135|Secondary|Change in Cystatin C||baseline and day 60|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.||mg/L||Standard Deviation|Mean
753527|NCT00577031|Secondary|Duration of Overall Response Among Participants Whose Best Response Was CR or PR During First Line Treatment - Time to Event|For participants with a best overall response of CR or PR, the duration of overall response was measured from the time that the criteria for CR or PR (whichever occurred first) was met until the first date that progressive disease was objectively documented or until the date of death due to underlying cancer, whichever occurred first. Data for participants who did not have an event or who were alive without an objectively documented progressive disease were censored at the date of last adequate tumor assessment. Median duration of overall response was estimated using the Kaplan-Meier method.|Baseline, every 3 weeks (every cycle) to disease progression or death up to 5 years|ITT population, only those participants who achieved a best overall response of CR or PR during first line treatment were included in the analysis.||months||95% Confidence Interval|Median
753528|NCT00577031|Secondary|Percentage of Participants With a Best Overall Response of CR or PR During First Line Treatment|CR and PR were defined using RECIST v1.0 criteria. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal (short axis <10 mm). No new lesions. PR was defined as a ≥30% decrease under baseline of the sum of diameters of all target lesions. Short axis was used in sum for target nodes, while longest diameter was used in sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.|Baseline, every 3 weeks (every cycle) to disease progression or death up to 5 years|ITT population, only those participants who achieved a best overall response of CR or PR during first line treatment were included in the analysis.||percentage of participants|||Number
753529|NCT00577031|Secondary|Time to CR or PR Overall Response - Time to Event|Time to overall response (CR or PR) was calculated as the time between the date of start of treatment until first documented response (CR or PR defined per RECIST v1.0). Participants who did not achieve CR or PR were censored at the date of progression, death, or at last adequate tumor assessment date. Median time to CR or PR overall response was estimated using the Kaplan-Meier method.|Baseline, every 9 weeks (every 3 cycles) until end of treatment, disease progression, or withdrawal up to 5 years|ITT population.||months||95% Confidence Interval|Median
753530|NCT00577031|Primary|PFS: Time to Event|PFS was defined as the time period in months from the start of study treatment to the first observation of disease progression or death from any cause, whichever occurred first. Data for participants with no tumor assessments after baseline but who were still alive at the time of the clinical cutoff were censored at Day 1. Participants who underwent surgery after experiencing a sufficient shrinkage of the tumor, had any relapse, new occurrence of colorectal cancer, or who died were all considered as having had an event. Participants who underwent surgery without any such event were censored at the date of the last tumor assessment that documented that neither a relapse nor a new colorectal cancer had occurred. Median PFS was estimated using the Kaplan-Meier method.|Baseline and Day 1 of every cycle until disease progression or death up to 5 years|ITT population.||months||95% Confidence Interval|Median
753531|NCT00577031|Secondary|Percentage of Participants With a CR or PR Among Participants in the ITT Population|CR and PR were defined using RECIST v1.0. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal (short axis <10 mm). No new lesions. PR was defined as a ≥30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.|Baseline, every 9 weeks (every 3 cycles) until end of treatment, disease progression, or withdrawal up to 5 years|ITT population.||percentage of participants|||Number
753532|NCT00577031|Secondary|Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) Among Participants in the ITT Population Who Had at Least 1 Post-Baseline Assessment|The percentage of participants with a best overall response of CR or PR according to RECIST. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal (short axis less than [<]10 millimeters [mm]). No new lesions. PR was defined as a greater than or equal to (≥) 30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.|Baseline, every 9 weeks (every 3 cycles) until end of treatment, disease progression, or withdrawal up to 5 years|Subset of participants in the ITT population who had at least 1 post-baseline tumor assessment.||percentage of participants|||Number
753533|NCT00577031|Primary|Progression-Free Survival (PFS): Percentage of Participants With Progressive Disease or Death|PFS was defined as the time period in months from the start of study treatment to the first observation of disease progression or death from any cause, whichever occurred first. Data for participants with no tumor assessments after baseline but who were still alive at the time of the clinical cutoff were censored at Day 1. Participants who underwent surgery after experiencing a sufficient shrinkage of the tumor, had any relapse, new occurrence of colorectal cancer, or who died were all considered as having had an event. Participants who underwent surgery without any such event were censored at the date of the last tumor assessment that documented neither a relapse nor a new colorectal cancer had occurred. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20 percent (%) increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Baseline and Day 1 of every cycle until disease progression or death up to 5 years|Intent-to-treat (ITT) population: all enrolled participants who received at least 1 dose of all study medications and had at least 1 measurable lesion according to the Response Evaluation Criteria In Solid Tumours (RECIST) criteria.||percentage of participants|||Number
753534|NCT00577083|Secondary|Time for Examination Will be Measured With a Stopwatch, and the Stopwatch Will be Stopped at Any Time a Polyp is Located and Restarted When the Polyp Has Been Removed and Retrieved.|During the second colonoscopy, all polyps will also be removed when detected. Any polyp identified and removed during the second procedure will be counted as a miss for the first procedure. All polyps will be sent separately for pathologic evaluation. The time required to remove and retrieve polyps with and without the cap on will be measured using a stopwatch as a secondary end point. The primary end point will be the miss rate for colonoscopy with the cap and colonoscopy without the cap.|after 2nd colonoscopy was completed in 24hrs||08/2017||||
753544|NCT00577096|Primary|Number of Red Blood Cell Transfusions Needed to Maintain Hemoglobin Levels (Long Term)|The targeted hemoglobin level for each participant was 10-12 g/dl. This is the number of red blood cell (RBC) transfusions administered to participants, as part of the investigational therapy algorithm, in an attempt to alleviate the anemia caused by multiple myeloma and high-dose chemotherapy. The numbers of RBC and platelet transfusions were obtained from the University of Arkansas for Medical Sciences blood bank.|up to 30 weeks|For the exercise group 8 participants who entered the study were not included in the analysis (2 withdrew from myeloma treatment, 1 died, 5 withdrew from study). For the usual care group 7 were not included in the analysis (3 withdrew from myeloma treatment, 1 died, 3 withdrew from study).||RBC Transfusions||Standard Deviation|Mean
753545|NCT00577096|Primary|Number of Red Blood Cell Transfusions Needed to Maintain Hemoglobin Levels (Short Term)|The targeted hemoglobin level for each participant was 10-12 g/dl. This is the number of red blood cell (RBC) transfusions administered to participants, as part of the investigational therapy algorithm, in an attempt to alleviate the anemia caused by multiple myeloma and high-dose chemotherapy. The numbers of RBC and platelet transfusions were obtained from the University of Arkansas for Medical Sciences blood bank.|up to 15 weeks|For the exercise group 8 participants who entered the study were not included in the analysis (2 withdrew from myeloma treatment, 1 died, 5 withdrew from study). For the usual care group 7 were not included in the analysis (3 withdrew from myeloma treatment, 1 died, 3 withdrew from study).||RBC Transfusions||Standard Deviation|Mean
753546|NCT00577122|Secondary|MPA Trough Concentration|To explore genetic determinants of MPA bioavailability and trough concentration by showing average MPA levels at cycle 1 (Day 10-14) and cycle 2 (Day 1).|Cycle 1 (Day 10-14) and Cycle 2 (Day 1)|All patients with available data||ng/mL||Standard Deviation|Mean
753547|NCT00577122|Secondary|MPA Trough Level > 50 ng/mL When Have Clinical Benefit|To explore the relationship between MPA trough level and clinical benefit. This is done by seeing if the MPA concentrations remained > 50 ng/mL after initial dose escalation for those patients who showed clinical benefit. The number shows how many of the patients who showed clinical benefit had MPA concentrations > 50 ng/mL.|baseline through end of treatment|Patients who showed clinical benefit (CR, PR, or SD > 6 months)||participants|||Number
753548|NCT00577122|Secondary|Grade 3 or 4 Adverse Events Related to Treatment|To evaluate the toxicity of MPA and MPA + ldoCM in this patient population by the number of patients who have grade 3 or 4 adverse events that are related to treatment.|baseline through end of treatment|All patients in the study||participants|||Number
753549|NCT00577122|Primary|Clinical Benefit Rate (CR + PR + SD > 6 Months).|To determine the clinical benefit rate (Complete Response + Partial Response + Stable Disease > 6 months) per Response Evaluation Criteria in Solid tumors (RECIST version 1.0). of MPA monotherapy and MPA + low dose oral cyclophosphamide and methotrexate (ldoCM) in patients with refractory hormone receptor negative metastatic breast cancer. This will show the percent of patients who had Clinical Benefit and the Exact 95% Confidence Interval.|baseline through end of study, up to 3 years|All Patients on study.||Percent of Participants||95% Confidence Interval|Number
753550|NCT00577135|Secondary|Net Fluid Loss||Through 72 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.||mL||Standard Deviation|Mean
753551|NCT00577135|Secondary|Net Fluid Loss||Through 48 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.||mL||Standard Deviation|Mean
753552|NCT00577135|Secondary|Net Fluid Loss||Through 24 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.||mL||Standard Deviation|Mean
753553|NCT00577135|Secondary|Treatment Failure|Treatment failure is defined as the patient met cardiorenal syndrome endpoint, worsening or persistent heart failure endpoint, patient died, or there was clinical evidence of overdiuresis requiring intervention within first 72 hours after randomization|Within 72 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.||percentage of participants|||Number
753554|NCT00577135|Secondary|Presence of Cardiorenal Syndrome||Within 72 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.||percentage of participants|||Number
753555|NCT00577135|Secondary|Change in NTproBNP||baseline and Day 60|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.||pg/mL||Standard Deviation|Mean
753556|NCT00577135|Secondary|Change in NTproBNP||baseline and Day 7|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.||pg/mL||Standard Deviation|Mean
753557|NCT00577135|Secondary|Change in B-type Natriuretic Peptide|Change in NTproBNP|baseline and 72 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.||pg/mL||Standard Deviation|Mean
753558|NCT00577135|Secondary|Change in Uric Acid||baseline and Day 60|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.||mg/dL||Standard Deviation|Mean
753559|NCT00577135|Secondary|Change in Uric Acid||baseline and day 7|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.||mg/dL||Standard Deviation|Mean
753564|NCT00577135|Secondary|Dyspnea VAS|Dyspnea Visual Analog Scale Scale Range 0-4800; higher score is better|48 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.||units on a scale||Standard Deviation|Mean
753565|NCT00577135|Secondary|Patient Well Being, as Determined by a Visual Analog Scale|Global Visual Analog Scale Scale Range 0-4800; higher score is better|48 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.||units on a scale||Standard Deviation|Mean
753566|NCT00577135|Secondary|Patient Well Being, as Determined by a Visual Analog Scale|Global Visual Analog Scale Scale Range 0-2400; higher score is better|Measured at 24 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.||units on a scale||Standard Deviation|Mean
753567|NCT00577135|Secondary|Change in Serum Creatinine||baseline and day 60|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.||mg/dL||Standard Deviation|Mean
753568|NCT00577135|Secondary|Change in Serum Creatinine||baseline and day 7|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.||mg/dL||Standard Deviation|Mean
753569|NCT00577135|Secondary|Change in Serum Creatinine||baseline and 96 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.||mg/dL||Standard Deviation|Mean
753570|NCT00577135|Secondary|Change in Serum Creatinine||baseline and 48 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.||mg/dL||Standard Deviation|Mean
753571|NCT00577135|Secondary|Change in Cystatin C||baseline and 72 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.||mg/L||Standard Deviation|Mean
753572|NCT00577135|Secondary|Change in Serum Creatinine||baseline and 24 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.||mg/dL||Standard Deviation|Mean
753573|NCT00577135|Secondary|Dyspnea, as Determined by Visual Analog Scales|Global Visual Analog Scale Scale Range 0-2400; higher score is better|Measured at 24 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.||units on a scale||Standard Deviation|Mean
753574|NCT00577135|Secondary|Proportion of Patients Free of Congestion||Measured at 72 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.||percentage of participants|||Number
753575|NCT00577135|Secondary|Change in Weight||baseline and 96 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.||lbs||Standard Deviation|Mean
753576|NCT00577135|Primary|Change in Serum Creatinine||Measured at baseline and 72 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.||mg/dL||Standard Deviation|Mean
753577|NCT00577135|Primary|Patient Well Being, as Determined by a Visual Analog Scale|Global Visual Analog Scale Scale Range 0-7200; higher score is better|Measured at 72 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.||units on a scale||Standard Deviation|Mean
753578|NCT00577356|Primary|Number of Participants With Pathological Complete Response.|CG1940/CG8711 was given along with docetaxel over a series of treatment prior to radical prostatectomy. Pathology of resected specimen was done to determine complete response, defined as no microscopic evidence of neoplastic cells in the resected specimen|The study evaluates 4 months of docetaxel and immunotherapy prior to radical prostatectomy followed by radical prostatectomy with an additional 3 months of immunotherapy after radical prostatectomy.|Study was stopped before analysis occured.||participants|||Number
753579|NCT00577382|Secondary|Time to Progression|Time to progression based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.|Disease was evaluated radiologically at baseline and every 8 weeks on treatment and long-term every 3 months until first progression, death or lost to follow-up. Mean treatment duration was 3 cycles (range 1-11; Cohort A/B mean 2/3 cycles).|The analysis dataset is comprised of treated patients. The majority of patients were off-treatment due to disease progression and thus the relevant observation time frame for this outcome is time on treatment.||months||95% Confidence Interval|Median
753580|NCT00577382|Secondary|Overall Survival|Overall survival (OS) is defined as the time from study entry to death or date last known alive.|Patients were followed long-term every 3 months until first progression, death or lost to follow-up. Median survival follow-up was 6.7 months (range 0.8-47.3 months; Cohort A/B median 7.7 m/ 6.2 m).|The analysis dataset is comprised of treated patients.||months||95% Confidence Interval|Median
753581|NCT00577382|Secondary|Best Overall Response Rate|The best overall response rate was defined as achieving partial response (PR) or complete response (CR) on treatment based on RECIST 1.0 criteria. Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.|Disease was evaluated radiologically at baseline and every 8 weeks on treatment. Mean treatment duration was 3 cycles (Cohort A/B mean 2/3 cycles). The range of treatment duration overall was 1-11 cycles.|The analysis dataset is comprised of treated patients.||proportion of participants||95% Confidence Interval|Number
753582|NCT00577382|Primary|2-month Progression-free Survival Rate|2-month progression-free survival rate was defined as the proportion of patients absent death or progression based on Response Evaluation Criteria In Solid Tumors Criteria (RECIST) before 2 months. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.|Disease was evaluated radiologically at baseline and every 8 weeks on treatment; Treatment continued for 12 months unless disease progression or unacceptable toxicity. Relevant for this endpoint was disease status at 2 months.|The analysis dataset is comprised of treated patients.||proportion of patients||95% Confidence Interval|Number
753583|NCT00577395|Secondary|Erosion Index of the Distal Radius|Study was terminated prior to acquiring any efficacy endpoints. No efficacy analyses were performed.|6 months|Study was terminated prior to acquiring any efficacy endpoints. No efficacy analyses were performed.|||||
753584|NCT00577395|Primary|Percent Change From Baseline in Erosion Index (A Ratio of Curve-like Structures to Plate-like Structures and is a Measure of the Degree of Structural Degradation) of the Distal Radius|"The percent was change from baseline in erosion index at the distal radius between the risedronate and placebo groups at Month 12 (the lower the percent change in erosion index, the greater the improvement of structural degradation); the last valid postbaseline measurement was to be used when the Month 12 value was missing (Last Observation Carried Forward or LOCF).
NOTE: The study was unable to recruit sufficient numbers of patients to meet with the protocol specified numbers, thus it was terminated early after 5 months. No efficacy analyses were performed."|12 months|Study was terminated prior to acquiring any efficacy endpoints. No efficacy analyses were performed.|||||
753585|NCT00577408|Primary|Treatment Retention|compliance with being retained in treatment protocol|over the course of 24 weeks or length of study participation|||Participants|||Count of Participants
753586|NCT00577460|Secondary|Modified Minnesota Impulsive Disorder Interview (mMIDI), Frequency of Patients With at Least One Abnormal Behavior, Treated Set|The mMIDI is a semi-structured interview designed to assess impulsive control disorders. The scale was modified to focus behaviors of: pathological gambling, compulsive buying and compulsive sexual behavioral.|Baseline, 80 weeks|Treated Set - all patients dispensed drug and documented to have taken at least one dose||participants|||Number
753587|NCT00577460|Secondary|Epworth Sleepiness Scale (ESS), Baseline and End of Open Label, Treated Set|ESS Total score ranges from zero (best) to 24 (worst); scale has 8 items, each rated from zero (no chance of dozing) to 3 (high chance of dozing)|OL Baseline and Week 80|||units on a scale||Standard Deviation|Mean
753588|NCT00577460|Secondary|Body Weight of Male Patients, Baseline and Week 80, Vital Signs Treated Set||OL Baseline and Week 80|Vital Signs Treated Set - All participants treated with study drug and have both baseline and week 80 vital sign data||kg||Standard Deviation|Mean
753589|NCT00577460|Secondary|Body Weight of Female Patients, Baseline and Week 80, Vital Signs Treated Set||OL Baseline and Week 80|Vital Signs Treated Set - All participants treated with study drug and have both baseline and week 80 vital sign data||kg||Standard Deviation|Mean
753590|NCT00577460|Secondary|Standing Pulse Rate, Baseline and Week 80, Vital Signs Treated Set||OL Baseline and Week 80|Vital Signs Treated Set - All participants treated with study drug and have both baseline and week 80 vital sign data||beats per minute||Standard Deviation|Mean
753591|NCT00577460|Secondary|Supine Pulse Rate, Baseline and Week 80, Vital Signs Treated Set||OL Baseline and Week 80|Vital Signs Treated Set - All participants treated with study drug and have both baseline and week 80 vital sign data||beats per minute||Standard Deviation|Mean
753592|NCT00577460|Secondary|Standing Systolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set||OL Baseline and Week 80|Vital Signs Treated Set - All participants treated with study drug and have both baseline and week 80 vital sign data||mm Hg||Standard Deviation|Mean
753593|NCT00577460|Secondary|Supine Systolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set||OL Baseline and Week 80|Vital Signs Treated Set - All participants treated with study drug and have both baseline and week 80 vital sign data||mm Hg||Standard Deviation|Mean
753594|NCT00577460|Secondary|Standing Diastolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set||OL Baseline and Week 80|Vital Signs Treated Set - All participants treated with study drug and have both baseline and week 80 vital sign data||mm Hg||Standard Deviation|Mean
753595|NCT00577460|Secondary|Supine Diastolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set||OL Baseline and Week 80|Vital Signs Treated Set - All participants treated with study drug and have both baseline and week 80 vital sign data||mm Hg||Standard Deviation|Mean
753596|NCT00577460|Primary|Percentage of Patients With Adverse Events, Adverse Drug Reactions, Serious Adverse Events|The aim of this study was to obtain long-term safety and tolerability data on pramipexole ER, in patients who have previously completed a pramipexole double blind study in advanced Parkinson's Disease (PD) (248.525 (NCT00466167)). Therefore these items were considered as a safety evaluation.|80 weeks|Patients from Treated Set (defined as all patients who were dispensed study drug and were documented to have at least one dose of investigational treatment)||Percentage of participants|||Number
753598|NCT00577460|Secondary|Number of Participants With Changes in Pramipexole Doses After 80 Weeks Compared to Pramipexole Dose at OL Baseline||OL baseline and week 80|Patients from Treated Set (all patients who were dispensed study drug and were documented to have at least one dose of investigational treatment) and treated until week 80||Patients|||Number
753599|NCT00577460|Secondary|Number of Participants With L-dopa Daily Dose Change: Change From OL Baseline at Week 80||OL baseline and week 80|Patients from FAS with documentation of levodopa (L-DOPA) daily dose at week 80||Patients|||Number
753600|NCT00577460|Secondary|Parkinson Fatigue Scale (PFS-16) Score and Change From OL Baseline at Week 80|PFS-16 (Parkinson fatigue scale) ranging from 16 (better perceived health status) to 80 (severe symptoms of the disease) measuring aspects of fatigue that are relevant to patients with PD|OL baseline and week 80|Patients from FAS with values of PFS-16 score at week 80||Unit on a scale||Standard Error|Least Squares Mean
753601|NCT00577460|Secondary|UPDRS IV Total Score and Change From OL Baseline at Week 80|UPDRS IV ranging from 0 (normal) to 23 (severe). UPDRS IV measures complications of therapy|OL baseline and week 80|Patients from FAS with values of UPDRS IV at week 80||Unit on a scale||Standard Error|Least Squares Mean
753602|NCT00577460|Secondary|UPDRS III Total Score and Change From OL Baseline at Week 80|UPDRS III ranging from 0 (normal) to 108 (severe). UPDRS part III measures motor symptoms|OL baseline and week 80|Patients from FAS with values of UPDRS III at week 80||units on a scale||Standard Error|Least Squares Mean
753603|NCT00577460|Secondary|UPDRS II Total Score and Change From OL Baseline at Week 80|UPDRS II ranging from 0 (normal) to 52 (severe). UPDRS Part II is calculated as the average of UPDRS part II at on and UPDRS part II at off-period for each of the 13 activities|OL baseline and week 80|Patients from FAS with values of UPDRS II at week 80||units on a scale||Standard Error|Least Squares Mean
753604|NCT00577460|Secondary|UPDRS I Total Score and Change From OL Baseline at Week 80|UPDRS I ranging from 0 (normal) to 16 (severe). UPDRS I measures Mentation, Behavior and Mood|OL baseline and week 80|Patients from FAS with values of UPDRS I at week 80||units on a scale||Standard Error|Least Squares Mean
753605|NCT00577460|Secondary|Number of Participants With Response in PGI-I for Early Morning Off Symptoms|"Patient Global Impression of Improvement (PGI-I) for early morning off symptoms, PGI-I scores ranging from '1' (very much better) to '7' (very much worse). For patients previously treated with Placebo, all patients with at least much better were considered as responders. For patients previously treated with PPX ER or IR, all patients with no change to very much better were considered as responders"|32 weeks|Patients from FAS with values of PGI-I for early morning off symptoms at week 32||Patients|||Number
753606|NCT00577460|Secondary|Number of Participants With Response in PGI-I|"Patient Global Impression of Improvement (PGI-I), PGI-I scores ranging from '1' (very much better) to '7' (very much worse). For patients previously treated with Placebo, all patients with at least much better were considered as responders. For patients previously treated with PPX ER or IR, all patients with no change to very much better were considered as responders"|32 weeks|Patients from FAS with values of PGI-I at week 32||Patients|||Number
753607|NCT00577460|Secondary|Number of Participants With Response in CGI-I|"Clinical Global Impression of Improvement (CGI-I), CGI-I scores ranging from '1' (very much improved) to '7' (very much worse). For patients previously treated with Placebo, all patients with at least much improved were considered as responders. For patients previously treated with PPX ER or IR, all patients with no change to very much improved were considered as responders"|32 weeks|Patients from FAS with values of CGI-I at week 32||Patients|||Number
753608|NCT00577460|Secondary|Percentage on Time With Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks|Percentage on-time with troublesome dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep. A positive change implies improvement|Baseline and week 80|Patients from FAS with values of on time during waking hours at week 80||percentage during waking hours||Standard Error|Least Squares Mean
753609|NCT00577460|Secondary|Percentage on Time Without Dyskinesia or With Non Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks|Percentage on-time without dyskinesia or with non troublesome dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep. A positive change implies improvement|Baseline and week 80|Patients from FAS with values of on time during waking hours at week 80||percentage during waking hours||Standard Error|Least Squares Mean
753610|NCT00577460|Secondary|Percentage on Time With Non Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks|Percentage on-time with non troublesome dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep. A positive change implies improvement|Baseline and week 80|Patients from FAS with values of on time during waking hours at week 80||percentage during waking hours||Standard Error|Least Squares Mean
753611|NCT00577460|Secondary|Percentage on Time Without Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks|Percentage on-time based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep. A positive change implies improvement.|Baseline and week 80|Patients from FAS with values of on time during waking hours at week 80||percentage during waking hours||Standard Error|Least Squares Mean
753612|NCT00577460|Secondary|Number of Participants With Response in Percentage Off Time During Waking Hours|Response means >=20% improvement relative to OL baseline in the % off-time during waking hours|80 weeks|Patients from FAS with values of off time during waking hours at 80 weeks||Patients|||Number
753613|NCT00577460|Secondary|Percentage Off Time During Waking Hours Total Score: Change From Baseline|"Percentage off-time based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). Off-time describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease).
A negative change implies improvement"|Baseline and week 80|Patients from FAS with values of UPDRS II+III at week 80||percentage during waking hours||Standard Error|Least Squares Mean
753667|NCT00577824|Secondary|7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24|Self-monitored blood glucose at 7 different time points during the day (glucose measurements before and 2 hours after the start of the morning, midday, and evening meals, and at bedtime).|baseline, week 24|Full Analysis Set; Last Observation Carried Forward||mg/dL||Standard Deviation|Mean
753614|NCT00577460|Secondary|Number of Patients Successfully Switched From PPX IR or ER to ER Assessed on Off-time|A patient was considered as successfully switched if he/she has converted to ER without a worsening of off time by more than 12.5% from baseline. Off-time is based on patient diary data and describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease).|One week|Patients from FAS and who maintain the final dose of the previous study||Patients|||Number
753615|NCT00577460|Secondary|Number of Participants With UPDRS II+III Response|A response means an improvement of >=20% in UPDRS II+III from OL baseline UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms|Week 80|Patients from FAS with values of UPDRS II+III at week 80||Patients|||Number
753616|NCT00577460|Secondary|UPDRS II+III Change From Open Label (OL) Baseline|UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms|OL Baseline and week 80|Patients from FAS with values of UPDRS II+III at week 80||Scores on a scale||Standard Error|Least Squares Mean
753617|NCT00577460|Secondary|Patients Successfully Switched From Pramipexole (PPX) IR or ER to ER Assessed on UPDRS II+III|Unified Parkinson’s Disease Rating Scale (UPDRS) Successfully switched means: UPDRS II+III baseline score >20 without a relative worsening of UPDRS II+III score > 15% from baseline or UPDRS II+III baseline score <=20 without an absolute worsening of UPDRS II+III score > 3 from baseline UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms|One week|Patients from Full Analysis Set (FAS included all patients who were dispensed study medication, had received at least one dose of study drug and had provided any post-baseline efficacy assessment) and who maintain the final dose of the previous study||Patients|||Number
753618|NCT00577473|Secondary|Improvement in Patient's Sigmoidoscopy Assessment Score at Week 6, All Randomized Patients (Percentage)|0-normal (intact vascular pattern, no friability or granularity), 1-mild (erythema; diminished or absent vascular markings; mild granularity; friability), 2-moderate (marked erythema, granularity; absent vascular markings; bleeds with minimal trauma; no ulcerations), 3-severe (spontaneous bleeding, ulcerations). Scoring Scale: 0-good thru 3-worse.|Week 6|All Randomized Patients||Percentage of Participants|||Number
753619|NCT00577473|Secondary|Improvement in Patient's Sigmoidoscopy Assessment Score at Week 3, All Randomized Patients (Percentage)|0-normal (intact vascular pattern, no friability or granularity), 1-mild (erythema; diminished or absent vascular markings; mild granularity; friability), 2-moderate (marked erythema, granularity; absent vascular markings; bleeds with minimal trauma; no ulcerations), 3-severe (spontaneous bleeding, ulcerations). Scoring Scale: 0-good thru 3-worse.|Week 3|All Randomized Patients||Percentage of Participants|||Number
753620|NCT00577473|Secondary|Improvement in Patient's Functional Assessment (PFA) at Week 6, All Randomized Patients (Percentage)|0-generally well, 1-fair, 2-poor, 3-terrible|Week 6|All Randomized Patients||Percentage of Participants|||Number
753621|NCT00577473|Secondary|Improvement in Patient's Functional Assessment (PFA) at Week 3, All Randomized Patients (Percentage)|0-generally well, 1-fair, 2-poor, 3-terrible|Week 3|All Randomized Patients||Percentage of Participants|||Number
753622|NCT00577473|Secondary|Rectal Bleeding Improvement at Week 6, All Randomized Patients (Percentage)|0-no blood seen, 1- streaks of blood with stool less than half of the time, 2- obvious blood with stool most of the time, 3- blood alone passed. Scoring Scale: 0-good thru 3-worse.|Week 6|All Randomized Patients||Percentage of Participants|||Number
753623|NCT00577473|Secondary|Rectal Bleeding Improvement at Week 3, All Randomized Patients (Percentage)|0: no blood seen, 1: streaks of blood with stool less than half of the time, 2: obvious blood with stool most of the time, 3: blood alone passed, Scoring Scale: 0-good thru 3-worse.|Week 3|All Randomized Patients||Percentage of Participants|||Number
753624|NCT00577473|Secondary|Stool Frequency Improvement at Week 6, All Randomized Patients (Percentage)|0: normal stool frequency per day, 1: 1-2 stools greater than normal per day, 2: 3-4 stools greater than normal per day, 3: 5 or more stools greater than normal per day, Scoring Scale: 0-good thru 3-worse.|Week 6|All Randomized Patients||Percentage of Participants|||Number
753625|NCT00577473|Secondary|Stool Frequency Improvement at Week 3, All Randomized Patients (Percentage)|0: normal stool frequency per day, 1: 1-2 stools greater than normal per day, 2: 3-4 stools greater than normal per day, 3: 5 or more stools greater than normal per day, Scoring Scale: 0-good thru 3-worse.|Week 3|All Randomized Patients||Percentage of Participants|||Number
753626|NCT00577473|Secondary|Physician's Global Assessment (PGA) Percentage of Patients Improved at Week 6, All Randomized Patients|PGA - 0-quiescent disease activity (all 0's) , 1-mild (mostly 1's), 2-moderate (mostly 2's), 3-severe (mostly 3's) based upon on scoring for stool frequency, rectal bleeding, PFR (patient's functional assessment - 0-well, 1-fair, 2-poor, 3-terrible), sigmoidoscopy findings. Improvement defined as complete response (remission, score = 0) or partial response (improvement on treatment). Scoring Scale: 0-good thru 3-worse.|Week 6|All Randomized Patients||Percentage of Participants|||Number
753627|NCT00577473|Secondary|Physician's Global Assessment (PGA) Percentage of Patients Improved at Week 3, All Randomized Patients|PGA - 0-quiescent disease activity (all 0's) , 1-mild (mostly 1's), 2-moderate (mostly 2's), 3-severe (mostly 3's) based upon on scoring for stool frequency, rectal bleeding, PFR (patient's functional assessment - 0-well, 1-fair, 2-poor, 3-terrible), sigmoidoscopy findings. Improvement defined as either complete response (remission, score = 0) or partial response (improvement on treatment). Scoring Scale: 0-good thru 3-worse.|Week 3|All Randomized Patients||Percentage of Participants|||Number
753628|NCT00577473|Secondary|Percentage of Patients Classified as Treatment Success at Week 3, ITT Population|Treatment Success - complete or partial response; Complete = complete resolution of clinical assessments (stool frequency, rectal bleeding, PFA [patient's functional assessment], sigmoidoscopy) and PGA (physician global assessment) = 0, Partial = improvement from baseline PGA score and improvement in at least 1 of the clinical assessments [decrease of at least 1 on scale] and no worsening [no score increases] of remaining clinical assessments. Each clinical assessment graded using scale 0/normal, better thru 3/severe, worse.|3 weeks|ITT Population||Percentage of Participants|||Number
753668|NCT00577824|Secondary|Change in Waist-to-hip Ratio|Change in waist-to-hip ratio from baseline to endpoint (i.e., waist-to-hip ratio at week 24 minus waist-to-hip ratio at week 0). Waist-to-hip ratio is waist circumference divided by hip circumference.|baseline, week 24|Full Analysis Set; Last Observation Carried Forward||ratio (cm/cm)||Standard Error|Mean
753629|NCT00577473|Primary|Percentage of Patients Classified as Treatment Success at Week 6, ITT Population|Treatment Success - complete or partial response; Complete = complete resolution of clinical assessments (stool frequency, rectal bleeding, PFA [patient's functional assessment], sigmoidoscopy) and PGA (physician global assessment) = 0, Partial = improvement from baseline PGA score and improvement in at least 1 of the clinical assessments [decrease of at least 1 on scale] and no worsening [no score increases] of remaining clinical assessments. Each clinical assessment graded using scale 0/normal, better thru 3/severe, worse.|6 weeks|ITT Population||Percentage of Participants|||Number
753632|NCT00577629|Secondary|Secondary Malignancies|The number of patients who develop secondary malignancies including solid tumors, acute leukemia and myelodysplasia or other bone marrow failure syndromes.|10 years|All patients who received chemotherapy||Participants|||Count of Participants
753633|NCT00577629|Secondary|Overall Response|"Percent of subjects who achieved a complete response (CR) or partial response (PR) any time during the treatment period.
CR = complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy.
PR =
>/= 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses.
No increase should be observed in the size of other nodes, liver, or spleen.
Splenic and hepatic nodules must regress by ≥ 50% in their SPD or, for single nodules, in the greatest transverse diameter.
Except splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present.
Patients who achieve a CR by the above criteria, but who have persistent morphologic bone marrow involvement will be considered partial responders.
No new sites of disease should be observed."|up to 1 year|||percentage of participants|||Number
753634|NCT00577629|Secondary|Overall Survival|Overall Survival is measured from the first day of chemotherapy until death from any cause.|10 years|All subjects who received chemotherapy||percentage of participants|||Number
753635|NCT00577629|Secondary|Disease-free Survival|Disease-free survival is measured from the date of CR or CRu to date of relapse or death|10 years|"Subjects who achieved a complete response. 9 patients experienced disease progression; 4 patients died.
4 patients were lost-to-follow-up and 11 patients are still living, so DFS was calculated using the last date of follow-up."||months||Full Range|Mean
753636|NCT00577629|Primary|1 Year Progression-free Survival Rate|Progression-free survival is measured from the first day of induction chemotherapy to the date of progression, relapse or death. Definitions of response criteria are as described by Cheson. Progressive Disease: >50% increase from nadir in the sum of the products of the greatest diameters (SPD) of any previously identified abnormal node for PDs or nonresponders, appearance of any new lesion during or at the end of therapy.|1 year|||percentage of participants||95% Confidence Interval|Number
753637|NCT00577642|Primary|Number of Participants With Urinary NTX Levels Less Than or Equal to 50nmol/mmol Cr|Number of participants with urinary NTX levels less than or equal to 50 nmol/mmol creatinine (Cr) for the duration of study followup, following a single dose Zoledronic Acid (Zoledronate) 4mg IV over at least 15 minutes (or dose corrected for creatinine clearance x1). Dose administration was followed by Aminobisphosphonates (aBP) treatment cessation during study period.|6 months|||Participants|||Count of Participants
753638|NCT00577655|Secondary|Weekly Average Number of Puffs of Rescue Medication Taken Each Day for Study Weeks 1, 2 and 3|Participants recorded every morning on awakening the number of asthma-related nocturnal awakenings requiring use of rescue medication that occurred during the previous night and the number of puffs of rescue albuterol used during the night after going to bed. At the end of each day, the number of puffs of albuterol rescue medication used during the day were recorded.|Weeks 1, 2, 3|ITT population||Number of puffs per day||95% Confidence Interval|Mean
753639|NCT00577655|Secondary|Weekly Average Peak Expiratory Flow (PEF) Obtained Pre-Dose Each Morning|Participants measured their PEF as trained by taking as deep a breath as possible, placing their mouth firmly around the mouthpiece of the flow meter to form a tight seal, and exhaling as hard and as fast as possible. Subjects repeated the process twice at intervals of approximately 30 seconds, and then recorded the highest of the three PEF values on the diary card.|Weeks 1, 2, 3|ITT population||Liters/minute||Standard Error|Mean
753640|NCT00577655|Secondary|The Number of Asthma-Related Nocturnal Awakenings Per Week Requiring the Use of Rescue Medication|Participants recorded every morning on awakening the number of asthma-related nocturnal awakenings requiring use of rescue medication that occurred during the previous night.|Run-in (Days -21 to -1), Weeks 1, 2, 3|ITT population||awakenings/week||Standard Deviation|Mean
753641|NCT00577655|Secondary|Weekly Average Highest (Worst) Daily Asthma Symptom Scores for Weeks 1, 2 and 3|"Highest daily asthma symptom scores by study week. For this assessment, patients self-evaluate and record on the diary card the following asthma symptoms experienced during the day (i.e. last 12-14 hours): wheeze, shortness of breath, cough, tightness of chest. The worst of these symptoms were scored daily on a four-point scale:
0 = No symptoms occurred
1 = Symptom occurred but did not interfere with daily activity
2 = Symptom occurred but was sometimes annoying or interfered with daily activity
3 = Symptom present even at rest and was annoying or interfered with daily activity"|Weeks 1, 2, 3|ITT population.||units on a scale||Standard Error|Mean
753642|NCT00577655|Secondary|Participant Responses: Percentage of Participants With a >=12% Increase in Baseline PEF Within 30 Minutes Post-Dose on Days 1 and 22|"The PEF test is conducted by having a person blow as hard as they can into a mouthpiece attached to a sensor that measures the rate of air blown. This outcome counts participants who responded to therapy by obtaining a >+12% increase in PEF within 30 minutes of dose.
The baseline PEF was defined as the average of the two test-day pre-dose baseline PEF values."|Days 1 and 22: 35±5 and 10±2 min prior to dosing, and at 5±2, 15±5, 30±5 post dosing|ITT||percentage of participants|||Number
753643|NCT00577655|Secondary|Participant Responses: Percentage of Participants With a >=15% Increase in Baseline PEF Within 30 Minutes Post-Dose on Days 1 and 22|"The PEF test is conducted by having a person blow as hard as they can into a mouthpiece attached to a sensor that measures the rate of air blown. This outcome counts participants who responded to therapy by obtaining a >+15% increase in PEF within 30 minutes of dose.
The baseline PEF was defined as the average of the two test-day pre-dose baseline PEF values."|Days 1 and 22: 35±5 and 10±2 min prior to dosing, and at 5±2, 15±5, 30±5 post dosing|ITT||percentage of participants|||Number
753644|NCT00577655|Secondary|Participant Responses: Percentage of Participants With a >=12% Increase in Baseline FEV1 Within 30 Minutes Post-Dose on Days 1 and 22|"The FEV1 test is conducted by having a person empty their lungs of air into a mouthpiece attached to a sensor that measures the amount of air blown measured in liters. This outcome counts participants who responded to therapy by obtaining a >+12% increase in FEV1 within 30 minutes of dose.
The baseline FEV1 was defined as the average of the two test-day pre-dose baseline FEV1 values."|Days 1 and 22: 35±5 and 10±2 min prior to dosing, and at 5±2, 15±5, 30±5 post dosing|ITT||percentage of participants|||Number
753645|NCT00577655|Secondary|Participant Responses: Percentage of Participants With a >=15% Increase in Baseline FEV1 Within 30 Minutes Post-Dose on Days 1 and 22|"The FEV1 test is conducted by having a person empty their lungs of air into a mouthpiece attached to a sensor that measures the amount of air blown measured in liters. This outcome counts participants who responded to therapy by obtaining a >+15% increase in FEV1 within 30 minutes of dose.
The baseline FEV1 was defined as the average of the two test-day pre-dose baseline FEV1 values."|Days 1 and 22: 35±5 and 10±2 min prior to dosing, and at 5±2, 15±5, 30±5 post dosing|ITT||percentage of participants|||Number
753646|NCT00577655|Secondary|Time To Maximum Peak Expiratory Flow (PEF) Over Six Hours Post-Dose On Days 1 and 22|"The PEF test is conducted by having a person blow as hard as they can into a mouthpiece attached to a sensor that measures the rate of air blown.
Time to maximum PEF is defined as the number of minutes required for the baseline PEF to increase to the highest PEF post-dose for the 6 hour observation period. Median time and confidence intervals obtained via separate Kaplan-Meier estimates for each study day."|Days 1 and 22: 30±5 and 5±2 minutes prior to dosing, and 7.5±2, 20±5, 35±5, 50±5, 65±10, 125±10 post dosing|ITT population; Last Observation Carried Forward (LOCF) used for Day 22||minutes||95% Confidence Interval|Median
753647|NCT00577655|Secondary|Time To Maximum Forced Expiratory Volume in One Second (FEV1) Over Six Hours Post-Dose On Days 1 and 22|"The FEV1 test is conducted by having a person empty their lungs of air into a mouthpiece attached to a sensor that measures the amount of air blown measured in liters.
Time to maximum FEV1 is defined as the number of minutes required for the baseline FEV1 to increase to the highest FEV1 post dose during the 6 hour observation period.
Median time and confidence intervals obtained via separate Kaplan-Meier estimates for each study day."|Days 1 and 22: 35±5 and 10±2 min prior to dosing, and at 5±2, 15±5, 30±5, 45±5, 60±10, 120 ±10 post dosing|Intent-To-Treat (ITT) population; Last Observation Carried Forward (LOCF) used for Day 22||minutes||95% Confidence Interval|Median
753648|NCT00577655|Secondary|Maximum Percent-Predicted FEV1 (Max PPFEV1, %) Observed up to Two Hours Following Completion of Dosing on Study Days 1 and 22 (Observed Case)|The FEV1 test is conducted by having a person empty their lungs of air into a mouthpiece attached to a sensor that measures the amount of air blown measured in liters. Values are then expressed as the percentage of FE1 values predicted for a 'normal' population. Predicted FEV1 values were computed and adjusted for age, height and gender according to Eigen et al. for subjects 4-5 years of age and to Quanjer et al. for subjects aged 6-11 years using American Thoracic Society (ATS) criteria.|Days 1 and 22: 5±2, 15±5, 30±5, 45±5, 60±10, 120 ±10 post dosing|Observed cases (i.e. available data only)||percentage of predicted FEV1||Standard Error|Mean
753649|NCT00577655|Secondary|Baseline-Adjusted Area-under-the Effect Curve for Peak Expiratory Flow (PEF) Over 6 Hours Post-dose on Day 22 Using Both Day 1 and Day 22 Baselines|"The PEF test is conducted by having a person blow as hard as they can into a mouthpiece attached to a sensor that measures the rate of air blown.
The area under-the-effect curves for PEF were calculated according to the trapezoidal rule and were based on actual (not scheduled) measurement times."|Baseline (Day 1 or Day 22: 30±5 and 5±2 minutes prior to dosing Day 22: 7.5±2, 20±5, 35±5, 50±5, 65±10, 125±10 post dosing or last observation|Intent-To-Treat (ITT) population with Last Observation Carried Forward (LOCF)||Liters/Minute*Hours||Standard Error|Mean
753650|NCT00577655|Secondary|Baseline Adjusted Area-under-the-Effect Curve for Percent of Predicted Forced Expiratory Volume in One Second (FEV1) Over 6 Hours Post-dose on Day 22 Using Both Day 1 and Day 22 Baselines|"The FEV1 test is conducted by having a person empty their lungs of air into a mouthpiece attached to a sensor that measures the amount of air blown measured in liters. Values are then expressed as the percentage of FE1 values predicted for a 'normal' population. Predicted FEV1 values were computed and adjusted for age, height and gender according to Eigen et al. for subjects 4-5 years of age and to Quanjer et al. for subjects aged 6-11 years using American Thoracic Society (ATS) criteria.
The area under-the-effect curves for percent-predicted FEV1 were calculated according to the trapezoidal rule and were based on actual (not scheduled) measurement times."|Baseline (Day 1 or Day 22: 35±5 and 10±2 minutes prior to dosing), Day 22 (5±2, 15±5, 30±5, 45±5, 60±10, 120±10, 240±10, and 360±10 minutes post-dosing or last observation)|Intent-To-Treat (ITT) population with Last Observation Carried Forward (LOCF)||Percent of Predicted FEV1 * Hours||Standard Error|Mean
753651|NCT00577655|Secondary|Maximum Percent Change From Baseline in Peak Expiratory Flow (PEF) up to Two Hours Post-Dose (PEFmax%0-2) on Study Days 1 and 22 Using Observed Cases|"The PEF test is conducted by having a person blow as hard as they can into a mouthpiece attached to a sensor that measures the rate of air blown. A standardized spirometer was used with the subject in the sitting or standing position (orientation had to be consistent for each subject during study visits) and wearing a nose clip. Whenever possible, evaluations were performed by the same respiratory therapist on the same calibrated spirometer at approximately the same time (±2 hrs).
The maximum percent change from baseline in the PEF observed up to 2 hours following completion of dosing on study days 1 and 22. The baseline PEF was defined as the average of the test-day pre-dose baseline PEF values.
The reason for the two primary endpoints was that FEV1 is difficult to obtain in children below 7 years of age."|Days 1 and 22: 30±5 and 5±2 minutes prior to dosing, and 7.5±2, 20±5, 35±5, 50±5, 65±10, 125±10 post dosing|Observed cases||percentage change from baseline||Standard Error|Mean
753669|NCT00577824|Secondary|Change in Waist Size|Change in waist size from baseline to endpoint (i.e., waist size at week 24 minus waist size at week 0)|baseline, week 24|Full Analysis Set; Last Observation Carried Forward||cm||Standard Error|Mean
753670|NCT00577824|Secondary|Change in Triglycerides|Change in triglycerides from baseline to endpoint (i.e., triglycerides at week 24 minus triglycerides at week 0)|baseline, week 24|Full analysis set; Last observation carried forward||mg/dL||Standard Error|Mean
753671|NCT00577824|Secondary|Change in High Density Lipoprotein Cholesterol (HDL-C)|Change in HDL-C from baseline to endpoint (i.e., HDL-C at week 24 minus HDL-C at week 0)|baseline, week 24|Full analysis set; Last observation carried forward.||mg/dL||Standard Error|Mean
753652|NCT00577655|Secondary|Maximum Percent Change From Baseline in Forced Expiratory Volume in One Second (FEV1) up to Two Hours Post-Dose (FEV1max%0-2, %) on Study Days 1 and 22 Using Observed Cases|"The FEV1 test is conducted by having a person empty their lungs of air into a mouthpiece attached to a sensor that measures the amount of air blown measured in liters. A standardized spirometer was used with the subject in the sitting or standing position (orientation had to be consistent for each subject during study visits) and wearing a nose clip. Whenever possible, evaluations were performed by the same respiratory therapist on the same calibrated spirometer at approximately the same time (±2 hrs).
The maximum percent change from baseline in FEV1 observed up to 2 hours following completion of dosing using test day baseline. The baseline FEV1 was defined as the average of the two test-day pre-dose baseline FEV1 values."|Days 1 and 22: 35±5 and 10±2 min prior to dosing, and at 5±2, 15±5, 30±5, 45±5, 60±10, 120 ±10 post dosing|Observed cases (i.e. available data only)||percentage change from baseline||Standard Error|Mean
753653|NCT00577655|Primary|Maximum Percent Change From Baseline in Peak Expiratory Flow (PEF) Observed up to Two Hours Post Dose (PEFmax%0-2) on Day 22|"The PEF test is conducted by having a person blow as hard as they can into a mouthpiece attached to a sensor that measures the rate of air blown. A standardized spirometer was used with the subject in the sitting or standing position (orientation had to be consistent for each subject during study visits) and wearing a nose clip. Whenever possible, evaluations were performed by the same respiratory therapist on the same calibrated spirometer at approximately the same time (±2 hrs).
The maximum percent change from baseline in the PEF observed up to 2 hours following completion of dosing using Day 22 baseline. The baseline PEF was defined as the average of the test-day pre-dose baseline PEF values.
The reason for the two primary endpoints was that FEV1 is difficult to obtain in children below 7 years of age."|30±5 and 5±2 minutes prior to dosing, and at 7.5±2, 20±5, 35±5, 50±5, 65±10, 125±10 post dosing on Day 22 or last observation|Intent-To-Treat (ITT) population with Last Observation Carried Forward (LOCF)||percentage change from baseline||Standard Error|Mean
753654|NCT00577655|Primary|Maximum Percent Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Observed up to Two Hours Post Dose (FEV1max%0-2) on Day 22|"The FEV1 test is conducted by having a person empty their lungs of air into a mouthpiece attached to a sensor that measures the amount of air blown measured in liters. A standardized spirometer was used with the subject in the sitting or standing position (orientation had to be consistent for each subject during study visits) and wearing a nose clip. Whenever possible, evaluations were performed by the same respiratory therapist on the same calibrated spirometer at approximately the same time (±2 hrs).
The maximum percent change from baseline in FEV1 observed up to 2 hours following completion of dosing using Day 22 baseline. The baseline FEV1 was defined as the average of the two test-day pre-dose baseline FEV1 values.
The reason for the two primary endpoints was that FEV1 is difficult to obtain in children below 7 years of age."|35±5 and 10±2 min prior to dosing, and at 5±2, 15±5, 30±5, 45±5, 60±10, 120 ±10 post dosing on Day 22 or last observation|Intent-To-Treat (ITT) population with Last Observation Carried Forward (LOCF)||percentage change from baseline||Standard Error|Mean
753655|NCT00577707|Secondary|To Determine the Response Rate, 3-year Overall Survival and Median Survival of Patients With Stage IB-IIIA NSCLC With a Known EGFR Mutation Receiving Neoadjuvant Chemotherapy and Erlotinib (and Adjuvant Erlotinib).||3 years||||||
753656|NCT00577707|Secondary|To Determine the Response Rate After 21 Days of Single Agent Erlotinib for Stage IB-IIIA NSCLC With a Known EGFR Mutation.||calculate the response rate after 21 days of single agent erlotinib||||||
753657|NCT00577707|Primary|To Determine the Pathologic Complete Response Rate for Patients With Stage IB-IIIA NSCLC With Tumors That Harbor an EGFR Mutation Treated With Neoadjuvant Chemotherapy + Erlotinib||Patients will undergo a CT scan of chest every 3 months for year 1 and every 4 months for year 2. In years 3 and 4, a chest CT or chest x-ray every 6 months.|||participants|||Number
753658|NCT00577720|Secondary|Percent Change in Serum BAP (Bone-specific Alkaline Phosphatase), ITT Population||Baseline and Week 13|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
753659|NCT00577720|Secondary|Percent Change in Urine NTX/Cr (Urine Type I Collagen Cross-linked N-telopeptide Corrected for Creatinine Clearance), ITT Population||Baseline and Week 13|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
753660|NCT00577720|Primary|Percent Change in Serum CTX (Type I Collagen C-telopeptide), ITT (Intent to Treat) Population||Baseline and Week 13|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
753661|NCT00577772|Primary|Oro-cecal Transit Time as Measured by SmartPill|Oro-cecal transit time is the period of time needed by the head of the meal to reach the cecum, which is frequently used as an indicator of small intestinal transit time. Oro-cecal transit was to be determined simultaneously in the study subjects by both the SmartPill technique and the lactulose H_2BT technique.|baseline to passage of SmartPill, passage of SmartPill estimated no more than 72 hours from baseline|Data were not analyzed as study was terminated early due to low enrollment.|||||
753662|NCT00577824|Secondary|Change in 1,5-anhydroglucitol|Change in 1,5-anhydroglucitol from baseline to endpoint (i.e., 1,5-anhydroglucitol at week 24 minus 1,5-anhydroglucitol at week 0)|baseline, week 24|Full Analysis Set; Last Observation Carried Forward||mcg/mL||Standard Error|Mean
753663|NCT00577824|Secondary|Change in C-peptide|Change in C-peptide from baseline to endpoint (i.e., C-peptide at week 24 minus C-peptide at week 0)|baseline, week 24|Full Analysis Set; Last Observation Carried Forward||ng/mL||Standard Error|Mean
753664|NCT00577824|Secondary|Change in Serum Insulin|Change in serum insulin from baseline to endpoint (i.e., serum insulin at week 24 minus serum insulin at week 0)|baseline, week 24|Full Analysis Set; Last Observation Carried Forward||mcU/mL||Standard Deviation|Mean
753665|NCT00577824|Secondary|Change in Homeostasis Model Assessment - Insulin Resistance (HOMA-R)|Change in HOMA-R from baseline to endpoint (i.e., HOMA-R at week 24 minus HOMA-R at week 0). HOMA-R is a measurement of insulin resistance.|baseline, week 24|Full Analysis Set; Last Observation Carried Forward||ratio||Standard Error|Mean
753666|NCT00577824|Secondary|Change in Homeostasis Model Assessment - Beta Cell Function (HOMA-B)|Change in HOMA-B from baseline to endpoint (i.e., HOMA-B at week 24 minus HOMA-B at week 0). HOMA-B is a measurement of beta cell function.|baseline, week 24|Full Analysis Set; Last Observation Carried Forward||ratio||Standard Error|Mean
753672|NCT00577824|Secondary|Change in Low Density Lipoprotein Cholesterol (LDL-C)|Change in LDL-C from baseline to endpoint (i.e., LDL-C at week 24 minus LDL-C at week 0)|baseline, week 24|Full analysis set; Last observation carried forward.||mg/dL||Standard Error|Mean
753676|NCT00577824|Secondary|Percentage of Patients Achieving HbA1c < 6.5%|Percentage of subjects whose HbA1c was >=6.5% at baseline who achieved an HbA1c < 6.5% at endpoint (i.e., number of eligible subjects who achieved HbA1c < 6.5% divided by total number of eligible subjects times 100)|24 weeks|Full analysis set; Last observation carried forward. Only subjects whose HbA1c was >=6.5% at baseline were included.||percentage of participants|||Number
753677|NCT00577824|Secondary|Percentage of Patients Achieving HbA1c < 7.0%|Percentage of subjects whose HbA1c was >=7.0% at baseline who achieved an HbA1c < 7.0% at endpoint (i.e., number of eligible subjects who achieved HbA1c < 7.0% divided by total number of eligible subjects times 100)|24 weeks|Full analysis set; Last observation carried forward. Only those patients with HbA1c >=7% at baseline included.||percentage of participants|||Number
753678|NCT00577824|Primary|Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 24|Change in HbA1c from baseline following 24 weeks of treatment (i.e., HbA1c at week 24 minus HbA1c at week 0)|baseline, 24 weeks|Full analysis set; Last observation carried forward.||Percentage of hemoglobin||Standard Error|Least Squares Mean
753679|NCT00577863|Primary|Number of Subjects With Forteo B Pen Complaints at 46 Weeks|Number of subjects with complaints after 46 weeks, and common complaints (at least 3% complaint rate), using Forteo B Pen. Functional Complaints were related to device malfunction; Nonfunctional were related to either cosmetic or perception concerns.|46 weeks|All participants who received at least one injection of study drug.||number of participants with complaints|||Number
753680|NCT00577863|Primary|Summary of Forteo B Pen Complaints at 46 Weeks|Summary of number of complaints, and common complaints (at least 3% complaint rate), from subjects using Forteo B Pen. Functional Complaints were related to device malfunction; Nonfunctional were related to either cosmetic or perception concerns.|46 weeks|All participants who received at least one injection of study drug.||number of complaints|||Number
753681|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - What Could Be Done to Improve the Forteo B Pen Instructions For Use|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of what could be done to improve the Forteo B Pen Instructions for Use.|8 weeks|All participants who received at least one injection of study drug and who answered the question.||participants|||Number
753682|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - When Do You Remove the Needle|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject response on when they remove the needle from their Forteo B Pen.|8 weeks|All participants who received at least one injection of study drug and who answered the question.||participants|||Number
753683|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - When Do You Attach a Needle|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject response on when they attach a needle to their Forteo B Pen.|8 weeks|All participants who received at least one injection of study drug and who answered the question.||participants|||Number
753684|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - Reusing Needles|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject response on whether or not they sometimes reuse needles.|8 weeks|All participants who received at least one injection of study drug and who answered the question.||participants|||Number
753685|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - Helps Me Manage My Osteoporosis Away From Home|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of whether the Forteo B Pen helps them manage their osteoporosis when they are away from home.|8 weeks|All participants who received at least one injection of study drug and who answered the question.||participants|||Number
753686|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - Helps Me Manage My Osteoporosis At Home|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of whether the Forteo B Pen helps them manage their osteoporosis when they are at home.|8 weeks|All participants who received at least one injection of study drug and who answered the question.||participants|||Number
753687|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - Reduces My Reluctance to Take Injections|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of whether the Forteo B Pen reduces their reluctance to take injections.|8 weeks|All participants who received at least one injection of study drug and who answered the question.||participants|||Number
753688|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - Convenient for Me to Use|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how convenient Forteo B Pen was to use.|8 weeks|All participants who received at least one injection of study drug and who answered the question.||participants|||Number
753689|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - How Confident Are You That You Receive the Medication With Your Forteo B Pen|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how confident they were that they received the medication with the Forteo B Pen.|8 weeks|All participants who received at least one injection of study drug and who answered the question.||participants|||Number
753690|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - To What Extent Are You Satisfied With the Forteo B Pen|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how satisfied they were with the Forteo B Pen.|8 weeks|All participants who received at least one injection of study drug and who answered the question.||participants|||Number
753691|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - Overall Ease of Use|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of the overall ease of use.|8 weeks|All participants who received at least one injection of study drug and who answered the question.||participants|||Number
772061|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 7|Subject Satisfaction - width when inflated|6 months post-surgery|||% satisfactory or somewhat satisfactory|||Number
753692|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - Easy to Use the Forteo B Pen Instructions For Use|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how easy it was to use the Forteo B Pen Instructions for Use.|8 weeks|All participants who received at least one injection of study drug and who answered the question.||participants|||Number
753693|NCT00577863|Secondary|Summary of Subject Perceptions (Attributes) Assessments - Easy to Hold the Pen While Injecting|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how easy it was to hold the pen while injecting.|8 weeks|All participants who received at least one injection of study drug and who answered the question.||participants|||Number
753694|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - Easy to Push the Black Injections Button to Administer the Dose|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how easy it was to push the black injections button to administer the dose.|8 weeks|All participants who received at least one injection of study drug and who answered the question.||participants|||Number
753695|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - Easy to Set the Dose|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how easy it was to set the dose.|8 weeks|All participants who received at least one injection of study drug and who answered the question.||participants|||Number
753696|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - Easy to Remove a Used Needle|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how easy it was to remove a used needle.|8 weeks|All participants who received at least one injection of study drug and who answered the question.||participants|||Number
753697|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - Easy to Attach a New Needle|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how easy it was to attach a new needle.|8 weeks|All participants who received at least one injection of study drug and who answered the question.||participants|||Number
753698|NCT00577863|Secondary|Summary of Subject Perception (Attibutes) Assessments - Easy to Replace The Pen Cap|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how easy it was to replace the pen cap.|8 weeks|All participants who received at least one injection of study drug and who answered the question.||participants|||Number
753699|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - Easy to Remove The Pen Cap|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how easy it was to remove the pen cap.|8 weeks|All participants who received at least one injection of study drug and who answered the question.||participants|||Number
753700|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - Easy to Learn to Use the Pen|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how easy it was to learn to use the pen.|8 weeks|All participants who received at least one injection of study drug and who answered the question.||participants|||Number
753701|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - Easy to Read Label|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how easy it was to read the label.|8 weeks|All participants who received at least one injection of study drug and who answered the question.||participants|||Number
753702|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - Easy to Remove Pen From Package|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how easy it was to remove the pen from the package.|8 weeks|All participants who received at least one injection of study drug and who answered the question.||participants|||Number
753703|NCT00577863|Secondary|Summary of Subject Preference Assessments - Use of the User Manual/Instructions for Use That Came With the Pen|To assess subject preferences for use of the User Manual/Instructions for Use that came with the pen for the Forteo 1.1 Pen or the Forteo B Pen through a questionnaire at Visit 2 completed by subjects who switch from the Forteo 1.1 Pen prior to the study entry to the Forteo B Pen during study participation.|4 weeks|All participants who received at least one injection of study drug and are currently using the Forteo 1.1 Pen who answered the question.||participants|||Number
753704|NCT00577863|Secondary|Summary of Subject Preference Assessments - Overall Ease of Use|To assess subject preferences for overall ease of use for the Forteo 1.1 Pen or the Forteo B Pen through a questionnaire at Visit 2 completed by subjects who switch from the Forteo 1.1 Pen prior to the study entry to the Forteo B Pen during study participation.|4 weeks|All participants who received at least one injection of study drug and are currently using the Forteo 1.1 Pen who answered the question.||participants|||Number
753705|NCT00577863|Secondary|Summary of Subject Preference Assessments - Removing a Used Needle|To assess subject preferences for removing a used needle for the Forteo 1.1 Pen or the Forteo B Pen through a questionnaire at Visit 2 completed by subjects who switch from the Forteo 1.1 Pen prior to the study entry to the Forteo B Pen during study participation.|4 weeks|All participants who received at least one injection of study drug and are currently using the Forteo 1.1 Pen who answered the question.||participants|||Number
753706|NCT00577863|Secondary|Summary of Subject Preference Assessments - Assurance That Drug is Delivered|To assess subject preferences for assurance that drug is delivered for the Forteo 1.1 Pen or the Forteo B Pen through a questionnaire at Visit 2 completed by subjects who switch from the Forteo 1.1 Pen prior to the study entry to the Forteo B Pen during study participation.|4 weeks|All participants who received at least one injection of study drug and are currently using the Forteo 1.1 Pen who answered the question.||participants|||Number
755314|NCT00593606|Primary|Change in Alkaline Phosphatase|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||Units/l||Standard Deviation|Mean
753707|NCT00577863|Secondary|Summary of Subject Preference Assessments - Force on the Plunger Needed to Inject a Dose|To assess subject preferences for force on the plunger needed to inject a dose for the Forteo 1.1 Pen or the Forteo B Pen through a questionnaire at Visit 2 completed by subjects who switch from the Forteo 1.1 Pen prior to the study entry to the Forteo B Pen during study participation.|4 weeks|All participants who received at least one injection of study drug and are currently using the Forteo 1.1 Pen who answered the question.||participants|||Number
753708|NCT00577863|Secondary|Summary of Subject Preference Assessments - Injecting a Dose|To assess subject preferences for injecting a dose for the Forteo 1.1 Pen or the Forteo B Pen through a questionnaire at Visit 2 completed by subjects who switch from the Forteo 1.1 Pen prior to the study entry to the Forteo B Pen during study participation.|4 weeks|All participants who received at least one injection of study drug and are currently using the Forteo 1.1 Pen who answered the question.||participants|||Number
753709|NCT00577863|Secondary|Summary of Subject Preference Assessments - Setting the Dose|To assess subject preferences for setting the dose for the Forteo 1.1 Pen or the Forteo B Pen through a questionnaire at Visit 2 completed by subjects who switch from the Forteo 1.1 Pen prior to the study entry to the Forteo B Pen during study participation.|4 weeks|All participants who received at least one injection of study drug and are currently using the Forteo 1.1 Pen who answered the question.||participants|||Number
753710|NCT00577863|Secondary|Summary of Subject Preference Assessments - Attaching a New Needle|To assess subject preferences for attaching a new needle for the Forteo 1.1 Pen or the Forteo B Pen through a questionnaire at Visit 2 completed by subjects who switch from the Forteo 1.1 Pen prior to the study entry to the Forteo B Pen during study participation.|4 weeks|All participants who received at least one injection of study drug and are currently using the Forteo 1.1 Pen who answered the question.||participants|||Number
753711|NCT00577863|Primary|Number of Subjects With Forteo B Pen Complaints at 8 Weeks|Number of subjects with complaints after 8 weeks, and common complaints (at least 3% complaint rate), using Forteo B Pen. Functional Complaints were related to device malfunction; Nonfunctional were related to either cosmetic or perception concerns.|8 weeks|All participants who received at least one injection of study drug.||number of participants with complaints|||Number
753712|NCT00577863|Secondary|Summary of Subject Preference Assessments - Learning to Use the Pen|To assess subject preferences for learning to use the pen for the Forteo 1.1 Pen or the Forteo B Pen through a questionnaire at Visit 2 completed by subjects who switch from the Forteo 1.1 Pen prior to the study entry to the Forteo B Pen during study participation.|4 weeks|All participants who received at least one injection of study drug and are currently using the Forteo 1.1 Pen who answered the question.||participants|||Number
753713|NCT00577863|Secondary|Summary of Subject Preference Assessments - Overall Preference|To assess overall subject preferences for the Forteo 1.1 Pen or the Forteo B Pen through a questionnaire at Visit 2 completed by subjects who switch from the Forteo 1.1 Pen prior to the study entry to the Forteo B Pen during study participation.|4 weeks|All participants who received at least one injection of study drug and are currently using the Forteo 1.1 Pen who answered the question.||participants|||Number
753714|NCT00577863|Primary|Summary of Forteo B Pen Complaints at 8 Weeks|Summary of number of complaints, and common complaints (at least 3% complaint rate), from subjects using Forteo B Pen. Functional Complaints were related to device malfunction; Nonfunctional were related to either cosmetic or perception concerns.|8 weeks|All participants who received at least one injection of study drug.||number of complaints|||Number
753715|NCT00564681|Secondary|Duration of Treatment Effect for Treatment Responders|Duration of Treatment Effect for Treatment Responders is defined as the number of days from the date of first treatment to the first visit after Week 4 of Treatment Cycle 1, at which the Total TWSTRS score reaches at least 90% of the baseline score. A treatment responder is defined as a patient who has at least a 30% reduction in Total TWSTRS score at Week 4 after the first treatment. The TWSTRS score measures the impact of cervical dystonia on patients (0=least symptoms and 85= worst symptoms).|Up to 6 Months|Intent-to-Treat: All enrolled patients||Days||95% Confidence Interval|Median
753716|NCT00564681|Secondary|Change From Baseline in Pain as Evaluated With the TWSTRS Pain Subscale at Week 4 of Treatment Cycle 1|Change from baseline in pain as evaluated with the TWSTRS pain subscale at Week 4 of Treatment Cycle 1. The TWSTRS pain subscale scores range from 0 to 20 (0=no pain and 20=worst pain), based on severity of neck pain (0=no pain and 10=worst pain), the duration of pain (0=none and 5=most), and the degree of disability (0=none and 5=most). A negative number change from Baseline represents a decrease in pain (improvement).|Baseline, Week 4|Intent-to-Treat: All enrolled patients||Scores on a Scale||Standard Deviation|Mean
753717|NCT00564681|Secondary|Patient’s Global Assessment of Response to Treatment at Week 4 of Treatment Cycle 1|Patient’s global assessment of response to treatment at Week 4 of Treatment Cycle 1. Responses were measured on a 9-point scale of +4 to -4, with higher scores denoting improvement in cervical dystonia: +4 was 'Complete abolishment of signs and symptoms (100% improvement)', 0 represented 'No change', and -4 represented 'Very marked worsening (about 100% worse or greater)'.|Week 4|Intent-to-Treat: All enrolled patients||Scores on a Scale||Standard Deviation|Mean
753718|NCT00564681|Secondary|Physician’s Global Assessment of Response to Treatment at Week 4 of Treatment Cycle 1|Physician’s global assessment of response to treatment at Week 4 of Treatment Cycle 1. Responses were measured on a 9-point scale of +4 to -4, with higher scores denoting improvement in cervical dystonia: +4 was 'Complete abolishment of signs and symptoms (100% improvement)', 0 represented 'No change', and -4 represented 'Very marked worsening (about 100% worse or greater)'.|Week 4|Intent-to-Treat: All enrolled patients||Scores on a Scale||Standard Deviation|Mean
753719|NCT00564681|Primary|Change From Baseline in Observed Total Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Score at Week 4 of Treatment Cycle 1|Change from baseline in observed TWSTRS score at Week 4 of Treatment Cycle 1. The TWSTRS is an assessment scale used to measure the impact of cervical dystonia on patients. The score is comprised of 3 subscales: Severity, Disability, and Pain, each of which is scored independently. The total of these 3 comprises the TWSTRS total score which is scored from 0 (least symptoms) to 85 (worst symptoms). Higher scores indicate a greater degree of symptom severity. A negative change from baseline represents improvement and a positive change from baseline indicates worsening.|Baseline, Week 4|Intent-To-Treat: All enrolled patients||Scores on a Scale||Standard Deviation|Mean
755315|NCT00593606|Primary|Change in Albumin|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||g/l||Standard Deviation|Mean
753720|NCT00564733|Primary|Overall Response Rate (Patients That Achieve a CR or PR)|Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|At the end of 4 cycles of treatment, up to 24 weeks.|All patients that signed consent and received at least one cycle of chemotherapy.||participants|||Number
753721|NCT00564850|Secondary|Triptorelin Plasma Levels||Month 1, 2, 3, 4, 5 and 6|Analysis was performed on the Pharmacokinetics (PK) Valid population defined as all participants who received at least one injection of 11.25 mg triptorelin pamoate and had at least one PK assessment. 2 participants had data missing at month 1,3 and 6. 1, 3 and 4 participants had data missing at month 2, 4 and 5 respectively.||ng/mL||Standard Deviation|Mean
753722|NCT00564850|Secondary|Uterine Length||Month 0, 3 and 6|Analysis was performed on female patients in the ITT population. 2 participants had missing data at month 3 and 6.||mm||Standard Deviation|Mean
753723|NCT00564850|Secondary|Difference Between Bone Age and Chronological Age|Bone age was defined according to Greulich and Pyle method. Chronological age was calculated using the date of birth.|Month 0 and 6|Analysis was performed on the ITT population. 33 participants were assessed. 4 participants had missing data at month 6.||years||Standard Deviation|Mean
753724|NCT00564850|Secondary|Change From Baseline in Growth Velocity (GV) SDS at Month 6|"Change from baseline of GV was calculated as: GV at month 6 - GV at baseline. GV SDS was calculated using SAS algorithm.
Growth velocity during the study was calculated using the two height measures as: GV = (Height at baseline - Height at screening)*365/delay between two height measures."|Baseline and month 6|Analysis was performed on the ITT population. If GV at screening was missing, the value was derived from data recorded between 5 to 19 months ago otherwise GV at screening was considered missing. 9 participants had missing data.||SD score||Standard Deviation|Mean
753725|NCT00564850|Secondary|Body Mass Index (BMI) SDS||Month 0, 3 and 6|Analysis was performed on the ITT population. 1 and 2 participants had missing data at month 0 and month 6 respectively.||SD score||Standard Deviation|Mean
753726|NCT00564850|Secondary|Height Standard Deviation Score (SDS)|Standard deviation (SD) is a standard term used in growth studies and represents Standard Deviations calculated as the patient value minus the mean divided by the standard deviation. Standard Deviation Scores vary depending on the age and sex of the child.|Month 0, 3 and 6|Analysis was performed on the ITT population. 2 participants had missing data at month 6.||SD score||Standard Deviation|Mean
753727|NCT00564850|Secondary|Change From Screening in Pubertal Stage (Tanner Method) at Month 6|Pubertal stage (graded from 1 to 5 for penis and breast development, graded from 1 to 6 for pubic hair development) according to the Tanner method was collected. A low stage (i.e. 1) corresponds to a pre-pubertal stage and a high stage (i.e. 5 or 6) to an adult stage. Any increase of grade was defined as 'increased' and no change in grade or a reduced grade was defined as 'stabilised or reduced'.|Between screening and month 6|Analysis was performed on the ITT population. 2 participants had missing data for pubic hair stage and breast stage.||participants|||Number
753728|NCT00564850|Secondary|Number of Girls With Inhibin B Levels < 6 pg/ml||Month 0, 3 and 6|Analysis was performed on female patients in the ITT population. 2 participants had missing data at month 3 and month 6.||participants|||Number
753729|NCT00564850|Secondary|Testosterone Level||Month 0, 3 and 6|Testosterone level from the male patient in the ITT population.||ng/ml|||Number
753730|NCT00564850|Secondary|Number of Girls With Oestradiol Levels ≤ 20 pg/ml||Month 0, 1, 2, 3, 4, 5 and 6|Analysis was performed on female patients in the ITT population. 2 participants had missing data at month 1, 3, 4 and 6. 1 participant and 3 participants had missing data at month 2 and 5 respectively.||participants|||Number
753731|NCT00564850|Secondary|Basal LH Level||Month 0, 1, 2, 3, 4, 5 and 6|Analysis was performed on ITT population. 2 participants had missing data at month 1, 3, 4 and 6. 1 and 3 participants had missing data at month 2 and month 5 respectively.||IU/L||Standard Deviation|Mean
753732|NCT00564850|Secondary|Basal FSH Level||Month 0, 1, 2, 3, 4, 5, and 6|Analysis was performed on the ITT population. 2 participants had missing data at month 1, 3, 4 and 6. 1 and 3 participants had missing data at month 2 and month 5 respectively.||IU/L||Standard Deviation|Mean
753733|NCT00564850|Secondary|Follicle Stimulating Hormone (FSH) Level Following GnRH Test||Screening, month 3 and 6|Analysis was performed on the ITT population. 3 participants and 2 participants had missing data at month 3 and month 6 respectively.||IU/L||Standard Deviation|Mean
753734|NCT00564850|Secondary|Number of Participants Whose Intravenous (i.v.) GnRH-stimulated LH Response Was ≤3 IU/L||Month 6|"Analysis was performed on Intention to Treat population (ITT) defined as all participants having received at least one injection of 11.25 mg triptorelin pamoate. n indicates the number of patients who had an assessment at the visit."||participants|||Number
753735|NCT00564850|Primary|Number of Participants With a GnRH-stimulated LH Level ≤3 IU/L||3 months after the first injection of triptorelin pamoate 11.25 mg|"Analyses performed on:
Intention to Treat (ITT): all patients having received ≥1 injection. Any subject with missing data is considered a non-responder.
Modified ITT (mITT): all ITT patients with ≥ Month 3 post-baseline assessment of primary efficacy criterion.
Per Protocol (PP): all mITT patients without major protocol deviations."||participants|||Number
753736|NCT00564876|Secondary|Safety and Tolerability of Adjuvant Dasatinib|Determine the safety and tolerability of adjuvant dasatinib in early stage NSCLC.|Duration of adjuvant treatment plus 30 days.|Due to insufficient accrual, data analysis was not performed.|||||
753737|NCT00564876|Secondary|Gene Expression Profile Activation of Src Pathways|Determine whether gene expression profile activation of Src pathways is correlated with anti-tumor activity of dasatinib in early stage NSCLC.|Baseline and after 3 weeks of dasatinib therapy at the time of definitive surgical resection.|Due to insufficient accrual, data analysis was not performed.|||||
753738|NCT00564876|Secondary|Safety and Tolerability of Neoadjuvant Dasatinib|Determine the safety and tolerability of neoadjuvant dasatinib in early stage NSCLC.|Screening / Baseline; Neoadjuvant dasatinib Cycle 1 Day 1 and Day 22|Due to insufficient accrual, data analysis was not performed.|||||
753739|NCT00564876|Primary|Response Rate|Response rate (radiologic and pathologic) in Stage IB and II to neoadjuvant dasatinib|First progression and survival every 3 months for 2 years, then every 6 months until 5 years, then yearly.||||||
753740|NCT00564889|Secondary|Overall Survival (OS)|Overall survival (OS) was defined as the time from registration to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% CI was estimated using the Kaplan Meier method.|Duration of study (up to 3 years)|||months||95% Confidence Interval|Median
753741|NCT00564889|Secondary|Progression Free Survival (PFS)|Progression free survival (PFS) was defined as the time from registration to hematologic progression or death of any cause. Progression free and alive patients were censored at the date of last follow-up. The median PFS with 95% CI was estimated using the Kaplan Meier method.|Duration of study (up to 3 years)|||months||95% Confidence Interval|Median
753742|NCT00564889|Secondary|Number of Participants With Severe Adverse Events|Severe adverse events were defined as grade 3 or higher, at least possibly related to study drugs. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.|Duration of study (up to 3 years)|||participants|||Number
753743|NCT00564889|Secondary|Number of Patients With Organ Response|"Organ response was evaluated on the basis of improvement of one or more affected organ; only one parameter was required to satisfy the criteria. Response needed to be maintained for a minimum of 3 months to be considered valid.
Renal response required a 50% reduction in 24-hour urine protein excretion (at least 0.5 g/d) with stable creatinine. Cardiac response required one of >= 2-mm reduction in the interventricular septal (IVS) thickness by echocardiogram, or improvement of ejection fraction by >= 20%, or improvement by 2 NYHA classes without an increase in diuretic use. Hepatic response required either >= 50% decrease in (or normalization of) an initially elevated alkaline phosphatase level or reduction in the size of the liver by at least 2 cm by radiographic determination. Gastrointestinal tract improvement was defined as normalization of a low serum carotene level, or reduction of diarrhea to < 50% of previous movements/day, or decrease in fecal fat excretion by 50%."|Duration of study (up to 3 years)|||participants|||Number
753744|NCT00564889|Primary|Number of Participants Who Achieved a Confirmed Response Defined as a Complete Response (CR), Very Good Partial Response (VGPR) or Partial Response (PR)|"Response that was confirmed on 2 consecutive evaluations during treatment.
Complete Response(CR): Complete disappearance of M-protein from serum and urine on immunofixation, normalization of Free Light Chain (FLC) ratio and <5% plasma cells in bone marrow.
Very Good Partial Response(VGPR): >=90% reduction in serum M-component; Urine M-Component <=100 mg per 24 hours.
Partial Response(PR): >=50% reduction in serum M-component and/or Urine M-Component >=90% reduction or <200 mg per 24 hours; or >=50% decrease in difference between involved and uninvolved FLC levels."|Duration on study (up to 3 years)|||participants|||Number
753745|NCT00564902|Primary|Macular Pigment Optical Density|Replicate measures of foveal 1 degree estimated central MPOD were evaluated with the Quantify® MPS 9000 macular pigment screener, a modified heterochromic flicker photometer (HFP). It employs alternating blue and green flickering light emitting diodes and fixation on a 1 degree target, so that a representative measurement at 0.5 degree off center from the fovea is calculated.|12 months|All participants in all arms were tested||Density units of Macular Pigment (du)||Standard Error|Mean
753746|NCT00564902|Primary|Macular Pigment Optical Density|Replicate measures of foveal 1 degree estimated central MPOD were evaluated with the Quantify® MPS 9000 macular pigment screener, a modified heterochromic flicker photometer (HFP). It employs alternating blue and green flickering LED's and fixation on a 1 degree target, so that a representative measurement at 0.5 degree off center from the fovea is calculated. The method has good repeatability (r = 0.97) and the data are comparable with an objective optical method based on retinal reflectometry (r = 0.78).|8 months|All participants in all arms were tested||Density units of Macular Pigment (du)||Standard Error|Mean
753747|NCT00564902|Secondary|100% Kinetic Field|Scotomas within the central 20 degree central macula visual field sensitivity was assessed at 5 contrast levels (20, 40, 60, 80, and full contrast). A yellow wavelength stimulus avoided confounding by the lens. Subjects outlined the boundaries of their scotoma(s) on an area-integrating and recording touch flat- screen RGB monitor displaying a central fixation point and movable horizontal/vertical raster lines. The computer calculated summed area of the scotoma(s) with arbitrary scaling from 6000 (dense scotoma) to 0 relative units (absence of scotoma).|12 Months|Eyes of all patients still in the trial were measured||Units on a scale (0 to 6000)||Standard Error|Mean
753748|NCT00564902|Secondary|6.5 Degrees Tritan Threshold|The ChromaTest© is a computerized psychophysical test of protan and tritan color thresholds against age-corrected data. The computer finds the endpoint of the test by a Modified Binary Search method; if response is correct, on the next presentation the color difference between letter and background is halved. If response is incorrect, the color -contrast is doubled. Incorrect responses prolong the test, but do not influence the final threshold. This method of determining thresholds leads to finite steps which reach a plateau at the color contrast sensitivity threshold.|12 months|Eyes of all patients still in the trial were measured||dB||Standard Error|Mean
753749|NCT00564902|Secondary|Contrast Sensitivity Function Photopic Distance|Distance photopic contrast sensitivity function (CSF) at 5 spatial frequencies (1.5, 3, 6, 12 & 20 cc/deg) was determined with the Functional Vision Analyzer® (Stereo Optical Co, Inc, Chicago, IL). Contrast sensitivity readings are shown as a curve. Visual acuity is plotted along the horizontal axis and contrast sensitivity along the vertical axis. Among the normally sighted people, both visual acuity and contrast sensitivity have a wide range of variation.Low population CSF is 0-200 units; normal population CSF is 200-300 units and suprathreshold CSF is 300+ units.|12 Months|Eyes of all patients still in the trial were measured||units on a scale||Standard Error|Mean
753750|NCT00564902|Secondary|Glare Recovery|Photostress glare recovery test involves exposing an individual eye to intense light, or retinal bleach, for a set duration of time and measuring the time taken for visual acuity to recover to a predetermined level. Glare photo-stress recovery (in seconds) following 30 seconds of continuous retinal bleach, was assessed using 2 line supra-threshold low contrast randomly presented Landolt Cs using the KOWA AS14B Night Vision Tester (KOWA Optimed, Tokyo, Japan).|12 Months|Eyes of all patients still in the trial were measured||Seconds||Standard Error|Mean
753786|NCT00570739|Secondary|Percent Achievement of <140 mg/dL Plasma Glucose Post 2 Hour Glucose Tolerance Test and Fasting Plasma Glucose <110 mg/dL in Pre-Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||Percent of participants|||Number
753751|NCT00564902|Secondary|Early Treatment Diabetic Retinopathy Study Distance Visual Acuity|Black and 10% contrast near reading visual acuity was assessed with a Colenbrander Mixed Contrast Reading Card with LogMAR letters (#4031, Precision Vision, LaSalle, Illinois). We determined single letter acuity on an ordinal VAS (Visual Acuity Scale). The largest letters were 0.05 LogMAR with a VAS = 35 while the most difficult smallest letters were LogMar 1.25 or VAS 105. The test card was held at 40 cm with best monocular refraction, and both low and high contrast letter acuity were assessed.|12 months|Eyes of all patients still in the trial were measured||units on a scale||Standard Error|Mean
753752|NCT00564902|Secondary|SHAPE Discrimination|We determined the target deformation detection thresholds, or amplitude of the minimum detectable distortion of a 1 degree foveal circular target. The peak spatial frequency of RF (radial frequency) patterns was 5 cyc/deg; the radial modulation frequency was 8 cyc/360°; mean radii were 0.5°, 1°, 2.0°, or 2.5°; and stimulus contrast was 80%. The highest % modulation score possible is 0.13 while the easiest (lowest score) was 10% modulation.|12 months|Eyes of all participants still in the trial were measured||% modulation||Standard Deviation|Mean
753753|NCT00564902|Primary|Macular Pigment Optical Density|Replicate measures of foveal 1 degree estimated central MPOD were evaluated with the Quantify® MPS 9000 macular pigment screener, a modified heterochromic flicker photometer (HFP). It employs alternating blue and green flickering LED's and fixation on a 1 degree target, so that a representative measurement at 0.5 degree off center from the fovea is calculated. The method has good repeatability (r = 0.97) and the data are comparable with an objective optical method based on retinal reflectometry (r = 0.78).|4 months|All participants in all arms were tested||Density units of Macular Pigment (du)||Standard Error|Mean
753754|NCT00564954|Primary|Change From Pre-dose (0 hr [Hour]) on the Swanson, Kotkin, Agler, M-Flynn & Pelham (SKAMP) Rating Scale Combined Score at 0.5 Hour During the 8- Hour Laboratory Classroom Day|SKAMP rating scale is comprised of 13 questions (7 questions on attention and 6 questions on deportment) evaluating classroom behavior; answers to each question range from 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 78.|0 hr and 0.5 hr post-dose|Intent to Treat (ITT) population: All randomized patients who had at least one dose of study medication and who had at least one post-dose efficacy measurement.||score on a scale||Standard Error|Least Squares Mean
753755|NCT00564954|Secondary|Change From Pre-dose in Number of Math Questions Answered Correctly on the Permanent Product Measure of Performance (PERMP) Math Test|Number of math questions answered correctly within a 10 minute period.|0, 0.5, 1, 2, 4, 6 and 8 hours|Intent to Treat (ITT) population.||questions correct||Standard Error|Least Squares Mean
753756|NCT00564954|Secondary|Change From Pre-dose (0 hr.) in Permanent Product Measure of Performance (PERMP) Math Test–Attempted Scores at All Timepoints (0.5, 1, 2, 4, 6, 8)|Number of math questions attempted within a 10 minute period.|0, 0.5, 1, 2, 4, 6 and 8 hours|Intent to Treat (ITT) population||questions attempted||Standard Error|Least Squares Mean
753757|NCT00564954|Secondary|Change From Pre-dose in SKAMP Deportment Score|SKAMP deportment sub-scale is comprised of 6 questions on behavior in the classroom; answers to each question range from 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 36.|0, 0.5, 1, 2, 4, 6 and 8 hours|Intent to Treat (ITT) population.||score on a scale||Standard Error|Least Squares Mean
753758|NCT00564954|Secondary|Change From Pre-dose in SKAMP Attention Score at All Timepoints (0.5, 1, 2, 4, 6, 8)|SKAMP attention sub-scale is comprised of 7 questions evaluating concentration in the classroom; answers to each question range from 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 42.|0, 0.5, 1, 2, 4, 6, and 8 hours|Intent to Treat (ITT) population||score on a scale||Standard Error|Least Squares Mean
753759|NCT00564954|Secondary|Change From Pre-dose (0 hr) in SKAMP Combined Score at All Times Excluding the 0.5 Hour Timepoint (Hours 1, 2, 4, 6, 8)|SKAMP rating scale is comprised of 13 questions (7 questions on attention and 6 questions on deportment) evaluating classroom behavior; answers to each question range from 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 78.|0, 1, 2, 4, 6, and 8 hr|Intent to Treat (ITT) population||score on a scale||Standard Error|Least Squares Mean
753760|NCT00565045|Secondary|Fugl-Meyer Assessment (Upper Extremity)|The participant was asked to perform specific coordinated and isolated shoulder, elbow, wrist, and hand movements. Each movement was rated by a therapist using a 3-point ordinal scale: 0, cannot perform; 1, perform partially; 2, perform fully) and summed to produce an overall score, with a range of 0 to 66 (the higher the score the better).|3 months post-treatment.|The participants who completed the 6-week treatment phase were analyzed.||units on a scale||Standard Error|Mean
753761|NCT00565045|Secondary|Arm Motor Abilities Test|The Arm Motor Abilities Test (AMAT) score is an average across 9 different compound activities of daily living (ADL) tasks composed of 1 to 3 component tasks, each of which was scored by a therapist using a 0 to 5 ordinal scale: 0, no attempt to use affected limb; 1, attempt to use affected limb but it doesn’t participate functionally; 2, affected limb is used only as a helper or stabilizer; 3, affected limb is used slowly or within synergy patterns; 4, affected limb use almost normal; 5, normal use. Each of the 9 tasks is scored and then the average score across the 9 tasks is calculated, with a range of 0 to 5.|3 months post-treatment.|The participants who completed the 6-week treatment phase were analyzed.||units on a scale||Standard Error|Mean
753762|NCT00565045|Secondary|Box and Blocks Score|The number of blocks picked up and moved across a barrier in 60 seconds|3 months post-treatment.|The participants who completed the 6-week treatment phase were included in the analysis.||blocks||Standard Error|Mean
753763|NCT00565045|Secondary|Finger Tracking Error|A 30-sec 0.1Hz sine wave track scrolled from right to left on a computer screen in front of the participant. The amplitude of the sine wave was scaled to match the middle 70% of the participant's voluntary finger active range of motion (AROM). A cursor on the computer screen moved up and down as the participant extended and flexed their index finger. The task was to trace the scrolling sine wave with the cursor. Tracking error was the average vertical distance between the cursor and the target trace. Since the track was scaled to the participant's finger AROM, the distance between the cursor and the target trace (and therefore the tracking error) is in units corresponding to the percentage (%) of the participant's finger active range of motion (AROM), hereafter abbreviated %AROM.|3 months post-treatment.|The participants who completed the 6-week treatment phase were included in the analysis.||% AROM||Standard Error|Mean
755316|NCT00593606|Primary|Change in White Blood Cell Count|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||Giga/l||Standard Deviation|Mean
753764|NCT00565045|Primary|Maximum Voluntary Finger Extension Angle (a Measure of Hand Impairment)|A custom-built electrogoniometer recorded the angles of the metacarpophalangeal (MP) and proximal interphalangeal (PIP) joints of the index finger simultaneously. Participants were seated with the forearm and wrist supported and stabilized in a neutral posture. From this resting postion, they were instructed to extend their fingers as fully as possible in response to a 4-sec audio cue. The MP and PIP angles were added together, providing a composite measure of degree of finger extension, where 0 degrees corresponds to full extension of the MP and PIP joints. The more negative the angle, the more flexed the finger.|3 months post-treatment.|The participants who completed the 6-week treatment phase were included in the analysis.||degrees||Standard Error|Mean
753765|NCT00570531|Secondary|The Proportion of Toxicities Experienced by Participants|To assess the toxicity of this regimen.|Every three weeks for one year|The study was unable to accrue the number of patients necessary to analyze the objective.|||||
753766|NCT00570531|Secondary|The Number of Patients Cancer Free at the Time of Surgery|Determination of whether the pre-operative treatment can eliminate all the cancer cells at the time of surgery.|1 year|The study was unable to accrue the number of patients necessary to analyze the objective.|||||
753767|NCT00570531|Primary|Disease Free Survival Time|The primary outcome that will be measured is the length of time that patients are alive without recurrence of cancer following this therapy.|5 years|The study was unable to accrue the number of patients necessary to analyze the primary objective.|||||
753768|NCT00570674|Secondary|Change in FACT-H&N Scores From Baseline to 24 Months|The FACT-G (Version 4) is a patient-reported outcome measure used to assess health-related quality of life in patients undergoing cancer therapy. The FACT-G is the original questionnaire that led to the development of the larger Functional Assessment of Chronic Illness Therapy (FACIT) collection of quality of life instruments. The survey assesses the impacts of cancer therapy in four domains: physical, social/family, emotional, and functional. The FACT-G is also offered with additional questions measuring cancer-specific factors that may affect quality of life, leading to the creation of the Functional Assessment of Cancer Therapy - Head and Neck (FACT-H&N), a validated measure. [List M, D’Antonio L, et al. Cancer 1996 (77)]|Baseline and 24 months||10/2017||||
753769|NCT00570674|Secondary|Change in FACT-H&N Scores From Baseline to 12 Months|The FACT-G (Version 4) is a patient-reported outcome measure used to assess health-related quality of life in patients undergoing cancer therapy. The FACT-G is the original questionnaire that led to the development of the larger Functional Assessment of Chronic Illness Therapy (FACIT) collection of quality of life instruments. The survey assesses the impacts of cancer therapy in four domains: physical, social/family, emotional, and functional. The FACT-G is also offered with additional questions measuring cancer-specific factors that may affect quality of life, leading to the creation of the Functional Assessment of Cancer Therapy - Head and Neck (FACT-H&N), a validated measure. [List M, D’Antonio L, et al. Cancer 1996 (77)]|Baseline and 12 months||10/2017||||
753770|NCT00570674|Secondary|Change in FACT-H&N Scores From Baseline to 6 Months|The FACT-G (Version 4) is a patient-reported outcome measure used to assess health-related quality of life in patients undergoing cancer therapy. The FACT-G is the original questionnaire that led to the development of the larger Functional Assessment of Chronic Illness Therapy (FACIT) collection of quality of life instruments. The survey assesses the impacts of cancer therapy in four domains: physical, social/family, emotional, and functional. The FACT-G is also offered with additional questions measuring cancer-specific factors that may affect quality of life, leading to the creation of the Functional Assessment of Cancer Therapy - Head and Neck (FACT-H&N), a validated measure. [List M, D’Antonio L, et al. Cancer 1996 (77)]|Baseline and 6 months||10/2017||||
753771|NCT00570674|Secondary|Change in FACT-H&N Scores From Baseline to 3 Months|The FACT-G (Version 4) is a patient-reported outcome measure used to assess health-related quality of life in patients undergoing cancer therapy. The FACT-G is the original questionnaire that led to the development of the larger Functional Assessment of Chronic Illness Therapy (FACIT) collection of quality of life instruments. The survey assesses the impacts of cancer therapy in four domains: physical, social/family, emotional, and functional. The FACT-G is also offered with additional questions measuring cancer-specific factors that may affect quality of life, leading to the creation of the Functional Assessment of Cancer Therapy - Head and Neck (FACT-H&N), a validated measure. [List M, D’Antonio L, et al. Cancer 1996 (77)]|baseline and 3 months||10/2017||||
753772|NCT00570674|Secondary|Duration PEG Therapy|Estimated as the time from registration to the date of PEG removal.|Assessed until time of PEG removal which was up to 18.4 months in this study cohort.|The analysis dataset is comprised of all patients with date of PEG removal (evaluable). Reporting within dose cohorts is not preferred given the small sample sizes.||months||Full Range|Mean
753773|NCT00570674|Secondary|2-Year Overall Survival [Phase I]|2-year overall survival is the proportion of patients alive at 2-years from study entry.|All patients were followed for survival for a minimum of 2 years. Median survival follow-up was 44.7 months (range 10-70) in this study cohort.|The analysis dataset is comprised of all treated phase I patients. Reporting within dose cohorts is not preferred given the small sample sizes.||proportion of participants||95% Confidence Interval|Number
753774|NCT00570674|Secondary|Overall Response Rate [Phase I]|Overall response (OR) rate was defined as achieving partial response (PR) or complete response (CR) based on RECIST 1.0 criteria on treatment. Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.|The primary re-staging assessment for response occurred 8-10 weeks following completion of treatment. Treatment duration was a mean (range) of 7.8 weeks (6.6-10.1).|The analysis dataset is comprised of all treated phase I patients. Reporting within dose cohorts is not preferred given the small sample sizes.||proportion of participants||95% Confidence Interval|Number
753801|NCT00570739|Secondary|Percent Change of Fasting Insulin in Pre-Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks||Baseline to 4, 8, 12, and 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||Percentage of change||Standard Error|Least Squares Mean
753775|NCT00570674|Primary|2-Year Disease-Free Survival [Phase II]|Disease-free survival (DFS) is defined as the time from registration to the earlier of disease recurrence or death from any cause. Patients alive without a recurrence are censored at the date of last disease evaluation. 2-year disease-free survival is the probability of patients remaining alive and progression-free at 2-years from study entry estimated using Kaplan-Meier methods. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or equivocal progression of non-target.|Disease assessments occurred 8-10 weeks following treatment end then every 4-6 weeks (yr 1), every 8-10 weeks (yr 2), quarterly (yr 3) and semiannually up to 2 yrs since last pt enrolled.|The phase II portion planned to enroll 34 participants including the phase I expansion cohort but the study did not continue beyond phase I.|||||
753776|NCT00570674|Primary|Dose Limiting Toxicity (DLT) [Phase I]|Dose limiting toxicities (DLT) were defined as treatment-related: 1) grade 3-4 non-hematological toxicity excluding untreated nausea, vomiting and diarrhea; dysphagia, esophagitis, mucositis/stomatitis, dermatitis/rash, 2) Grade 3 or greater febrile neutropenia occurring during chemoradiotherapy, 3) Grade 4 neutropenia lasting >/= 7 days and 4) Grade 3 thrombocytopenia. Grade 4 toxicities resulting in a treatment breaks > 7 days were considered DLTs.|Adverse event assessments occurred weekly on treatment; The observation period for DLT evaluation incorporated the 7 weeks of treatment.|The analysis dataset is comprised of all treated patients in the dose escalation cohorts.While no DLTs were observed in the first 3 DL 1 patients, the cohort was expanded to 6 patients due to safety and tolerability concerns. Upon further review, it was resolved that the Abraxane dose should not be increased in the setting of concurrent Erbitux.||Participants with DLT|||Number
753777|NCT00570674|Primary|Abraxane Maximum Tolerated Dose (MTD) [Phase I]|The Abraxane MTD in combination with carboplatin and concurrent IMRT is determined by the number of participants who experience a dose limiting toxicity (DLT). See subsequent primary outcome measure for the DLT definition. The MTD is defined as the highest dose at which fewer than one-third of participants experience a DLT. If no DLTs are observed then the MTD is not reached but the highest dose may then be the recommended phase II dose.|Adverse event assessments occurred weekly on treatment; The observation period for MTD evaluation incorporated the 7 weeks of treatment.|The MTD was not reached on this trial but the recommended phase II dose was the highest dose of Abraxane evaluated.||mg weekly|||Number
753778|NCT00570687|Primary|EGP AOC0-480 - Meal Challenge|EGP area over the curve from 0 to 480 minutes postdose|0-480 minutes|Amendment 1: Subjects with type 2 diabetes. All subjects crossed over to lispro treatment. Original protocol:Subjects with type 2 diabetes; all subjects received all doses; AOC could not be calculated for 1 subject for Exubera and 2 subjects for the other treatments.||µmol/kg||Standard Deviation|Mean
753779|NCT00570687|Primary|Minimum EGP - Meal Challenge|Minimum calculated EGP per subject as change from baseline|0-480 minutes|Amendment 1: Subjects with type 2 diabetes; all received TI and were crossed over to lispro; 3 subjects in the 90 U TI group had insufficient data. Original protocol:Subjects with type 2 diabetes; all subjects received all doses; EGPmin could not be calculated for 1 subject for Exubera and 2 subjects for the other treatments.||µmol/kg/min||Standard Deviation|Mean
753780|NCT00570687|Primary|Time to Minimum Endogenous Glucose Production (EGP) - Meal Challenge|Time to minimum EGP post dose|0-480 minutes|Amendment 1: Subjects with type 2 diabetes; all received TI and were crossed over to lispro; 3 subjects in the 90 U TI group had insufficient data. Original protocol:Subjects with type 2 diabetes; all subjects received all doses; EGPmin could not be calculated for 1 subject for Exubera and 2 subjects for the other treatments.||Minutes||Full Range|Median
753781|NCT00570713|Secondary|Best Overall Response Rate|Best overall response is the number of participants with a Complete Response (CR) or Partial Response (PR), as classified by independent blinded review of the CT or MRI images, based on RECIST 1.0. A CR is the disappearance of all target lesions. PR is at least a 30% decrease in the sum of the longest diameters of target lesions, taking as a reference the baseline sum longest diameter. Progressive Disease (PD) is at least a 20% increase in the sum of the longest diameters of target lesions or the appearance of one or more new lesions. Stable disease (SD) is neither CR, PR or PD.|Baseline to response up to 21 months|||percentage of participants|||Number
753782|NCT00570713|Secondary|Progression-free Survival|Progression-free Survival (PFS) is defined as the time from the date of randomization to the date of the first observation of disease progression (clinical or radiological) or death due to any cause. Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline. If progression or death is not observed, the PFS time will be censored at the date of the last tumor assessment without evidence of progression prior to the date of initiation of further anticancer treatment.|1-21 Months|||Months||95% Confidence Interval|Median
753783|NCT00570713|Primary|Overall Survival (OS)|This measure was defined as the time (in months) from the date of randomization to the date of death, whatever the cause. The primary endpoint was analyzed when 110 events (deaths) were observed. In the absence of death confirmation or for subjects alive at the time of analysis, the survival time will be censored at the date of the last study follow-up.|1-21 Months|||Months||95% Confidence Interval|Median
753784|NCT00570739|Secondary|Percent of Subjects Meeting Type 2 Diabetes Criteria (Fasting Plasma Glucose >or= to 126 mg/dL or Plasma Glucose >or= to 200 mg/dL Post 2 Hr Glucose Tolerance Test in Pre-Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||Percent of participants|||Number
753785|NCT00570739|Secondary|Percent Achievement of Hs-C-Reactive Protein <2.0 mg/L in Pre-Diabetic Subjects Whose Corresponding Baseline Value Was > or = to 2.0 mg/L From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||Percent of participants|||Number
772062|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 7|Subject Satisfaction - width when inflated|3 months post-surgery|||% satisfactory or somewhat satisfactory|||Number
753787|NCT00570739|Secondary|Percent Achievement of <100 mg/dL Fasting Plasma Glucose in Pre-Diabetic Subjects Whose Corresponding Baseline Value Was > or = to 100 mg/dL From Baseline to 4, 8, 12 and 16 Weeks||Baseline to 4, 8, 12 and 16 weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||Percent of participants|||Number
753788|NCT00570739|Secondary|Percent Achievement of <110 mg/dL Fasting Plasma Glucose in Pre-Diabetic Subjects Whose Corresponding Baseline Value Was > or = to 110 mg/dL From Baseline to 4, 8, 12, and 16 Weeks||Baseline to 4, 8, 12, and 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF||Percent of participants|||Number
753789|NCT00570739|Secondary|Percent Achievement of <140 mg/dL Plasma Glucose 2 Hours Post the Oral Glucose Tolerance Test in Pre-Diabetic Subjects Whose Corresponding Baseline Value Was >or= to 140 mg/dL From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||Percent of participants|||Number
753790|NCT00570739|Secondary|Area Under the Curve for Plasma Glucose From 0 to 120 Minutes During the Oral Glucose Tolerance Tests in Pre-Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||mg/dL*hr||Standard Error|Least Squares Mean
753791|NCT00570739|Secondary|Change in Waist-to-Hip Ratio in Pre-Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||Change in Ratio||Standard Error|Least Squares Mean
753792|NCT00570739|Secondary|Change in Body Weight in Pre-Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||lb||Standard Error|Least Squares Mean
753793|NCT00570739|Secondary|Percent of Subjects Achieving Low Density Lipoprotein-Cholesterol of <70 mg/dL at Weeks 8, 16 in Pre-Diabetic Subjects||Baseline to 8, and 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||Percent of participants|||Number
753794|NCT00570739|Secondary|Percent of Subjects Achieving Low Density Lipoprotein-Cholesterol of <100 mg/dL at Weeks 8, 16 in Pre-Diabetic Subjects||Baseline to 8, and 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||Percent of participants|||Number
753795|NCT00570739|Secondary|Change of C-Peptide Levels 2 Hours Post Oral Glucose Tolerance Test in Pre-Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||ng/mL||Standard Error|Least Squares Mean
753796|NCT00570739|Secondary|Change of Insulin Levels 2 Hours Post Oral Glucose Tolerance Test in Pre-Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||uIU/mL||Standard Error|Least Squares Mean
753797|NCT00570739|Secondary|Change of Glucose Levels 2 Hours Post Oral Glucose Tolerance Test in Pre-Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||mg/dL||Standard Error|Least Squares Mean
753798|NCT00570739|Secondary|Change of Glucose Levels 1 Hour Post Oral Glucose Tolerance Test in Pre-Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||mg/dL||Standard Error|Least Squares Mean
753799|NCT00570739|Secondary|Change of Glucose Levels 30 Minutes Post Oral Glucose Tolerance Test in Pre-Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||mg/dL||Standard Error|Least Squares Mean
753800|NCT00570739|Secondary|Change of Fasting C-peptide Levels in Pre-Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|||ng/mL||Standard Error|Least Squares Mean
753802|NCT00570739|Secondary|Percent Change of Fasting Plasma Glucose in Pre-Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks||Baseline to 4, 8, 12, and 16 weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||Percentage of change||Standard Error|Least Squares Mean
753803|NCT00570739|Secondary|Percent Change of HbA1c in Pre-Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks||Baseline to 4, 8, 12, and 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||Percentage of change||Standard Error|Least Squares Mean
753804|NCT00570739|Secondary|Change of Various Calculated Lipid Parameters in Pre-Diabetic Subjects From Baseline to 16 Weeks|These calculated values are reported as part of an NMR analysis. The calculations are done by LipoScience, Inc., and are proprietary.|Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||mg/dL||Standard Error|Least Squares Mean
753805|NCT00570739|Secondary|Particle Size of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||nm||Standard Error|Least Squares Mean
753806|NCT00570739|Secondary|Level of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. These 16 week analyses are both LOCF and no LOCF.||nmol/L||Standard Error|Least Squares Mean
753807|NCT00570739|Secondary|Percent Change in Hs-C-Reactive Protein in Pre-Diabetic Subjects From Baseline to 16 Weeks||Baseline 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||Percentage of change||Inter-Quartile Range|Median
753808|NCT00570739|Secondary|Percent Change in Triglycerides in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks||Baseline to 8, and 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||Percentage of change||Inter-Quartile Range|Median
753809|NCT00570739|Secondary|Percent Change in Apolipoprotein CIII in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks||Baseline to 8, and 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||Percentage of change||Standard Error|Least Squares Mean
753810|NCT00570739|Secondary|Percent Change in Apolipoprotein B in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks||Baseline to 8, and 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||Percentage of change||Standard Error|Least Squares Mean
753811|NCT00570739|Secondary|Percent Change in Apolipoprotein A-1 in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks||Baseline to 8, and 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||Percentage of change||Standard Error|Least Squares Mean
753812|NCT00570739|Secondary|Percent Change in Total Cholesterol in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks||Baseline to 8, and 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||Percentage of change||Standard Error|Least Squares Mean
753813|NCT00570739|Secondary|Percent Change in High Density Lipoprotein-Cholesterol in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks||Baseline to 8, and 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||Percentage of change||Standard Error|Least Squares Mean
753814|NCT00570739|Secondary|Percent Change in Non-High Density Lipoprotein-Cholesterol in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks||Baseline to 8, and 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||Percentage of change||Standard Error|Least Squares Mean
755317|NCT00593606|Primary|Change in Red Blood Cell Count|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||Tera/l||Standard Deviation|Mean
753815|NCT00570739|Secondary|Percent Change in Low Density Lipoprotein-Cholesterol in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks||Baseline to 8, and 16 Weeks|The No. analyzed=the full analysis set (FAS). The FAS included randomized subjects who took at least 1 dose of randomized medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables.||Percentage of change||Standard Error|Least Squares Mean
753816|NCT00570739|Secondary|Percent of Subjects Achieving Hs-C-Reactive Protein Goal of <2.0 mg/L When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||Percent of participants|||Number
753817|NCT00570739|Secondary|Percent of Subjects Achieving 2-Hr. Post Meal Glucose Goal of <180 mg/dL When Given to Drug-naïve, Diabetic Subjects From Baseline to Week 16||Baseline to Week 16|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||Percent of participants|||Number
753818|NCT00570739|Secondary|Percent Change of Various Calculated Lipid Parameters When Given as Initial Therapy to Drug-naïve, Diabetic From Baseline to 16 Weeks Subjects|These calculated values are reported as part of an NMR analysis. The calculations are done by LipoScience, Inc., and are proprietary.|Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||Percentage of change|||Number
753819|NCT00570739|Secondary|Change in Plasma Glucose Area Under the Curve (0 to 120 Minutes) From the Baseline Glucose Tolerance Test (GTT) to the 16 Week GTT||Baseline vs. 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||mg/dL*hr||Standard Error|Least Squares Mean
753820|NCT00570739|Primary|Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) in Pre-Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed=the full analysis set (FAS). The FAS included randomized subjects who took at least 1 dose of randomized medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. Last Observation Carried Forward was used for 16 week analyses.||Percentage of change in LDL-C||Standard Error|Least Squares Mean
753821|NCT00570739|Secondary|Change in Waist-to-Hip Ratio When Given to Drug-Naive Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||Ratio||Standard Error|Least Squares Mean
753822|NCT00570739|Secondary|Change in Body Weight When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||lb||Standard Error|Least Squares Mean
753823|NCT00570739|Secondary|Percent of Subjects Achieving Low Density Lipoprotein-Cholesterol Goal of <70 mg/dL at Weeks 8, 16 When Given as to Drug-naïve, Diabetics||Baseline to Weeks 8, and 16|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||Percent of participants|||Number
753824|NCT00570739|Secondary|Percent of Subjects Achieving Low Density Lipoprotein-Cholesterol of <100 mg/dL at Weeks 8, 16 When Given to Drug-naïve, Diabetic Subjects||Baseline to Weeks 8, and 16|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||Percent of participants|||Number
753825|NCT00570739|Secondary|Percent of Subject Achieving HbA1c Goal of <6.5% at Weeks 4, 8, 12, and 16 When Given to Drug-naïve, Diabetic Subjects||Baseline to 4, 8, 12 and 16 weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||Percent of particpants|||Number
753826|NCT00570739|Secondary|Percent of Subjects Achieving HbA1c Goal of <7.0% at Weeks 4, 8, 12, and 16 if Baseline HbA1c Was > or = to 7.0% When Given to Drug-naïve, Diabetics||Baseline to 4, 8, 12, and 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||Percent of participants|||Number
753827|NCT00570739|Primary|Percent Change of Hemoglobin A1C (HbA1C) From Baseline to 16 Weeks When Given as Initial Therapy to Drug-naïve, Diabetic Subjects.||Baseline to 16 weeks|The number analyzed equals the full analysis set. The full analysis set included all randomized subjects who took at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline efficacy variable measurement. This analysis set was used for the summary and analysis of all efficacy variables. LOCF was used.||Percentage of change of hemoglobin A1C||Standard Error|Least Squares Mean
753828|NCT00570739|Secondary|Change in the Calculated High Density Lipoprotein Cholesterol When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks|These calculated values are reported as part of an NMR analysis. The calculations are done by LipoScience, Inc., and are proprietary.|Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||mg/dL||Standard Error|Least Squares Mean
753829|NCT00570739|Secondary|Change in the Calculated Very Low Density Lipoprotein Triglycerides When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks|These calculated values are reported as part of an NMR analysis. The calculations are done by LipoScience, Inc., and are proprietary.|Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||mg/dL||Standard Error|Least Squares Mean
753830|NCT00570739|Secondary|Change in the Calculated Total Triglycerides When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||mg/dL||Standard Error|Least Squares Mean
753831|NCT00570739|Secondary|Change in the Size of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||nm||Standard Error|Least Squares Mean
753832|NCT00570739|Secondary|Change in the Levels of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||nmol/L||Standard Error|Least Squares Mean
753833|NCT00570739|Secondary|Percent Change of Apolipoprotein C3 (Apo C3)When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks||Baseline to 8, and 16 weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||Percentage of change in Apo C3||Standard Error|Least Squares Mean
753834|NCT00570739|Secondary|Percent Change of Apolipoprotein B (Apo B)When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks||Baseline to 8, and 16 weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||Percentage of change in Apo B||Standard Error|Least Squares Mean
753835|NCT00570739|Secondary|Percent Change of Apolipoprotein A-1 (Apo A-1) When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks||Baseline to 8, and 16 weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||Percentage of change in Apo A-1||Standard Error|Least Squares Mean
753836|NCT00570739|Secondary|Percent Change of Triglycerides (TG)When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks||Baseline to 8, and 16 weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||Percentage of change of TG||Inter-Quartile Range|Median
753837|NCT00570739|Secondary|Percent Change of Total Cholesterol (TC) When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks||Baseline to 8, and 16 weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||Percentage of change of TC||Standard Error|Least Squares Mean
753838|NCT00570739|Secondary|Percent Change of High Density Lipoprotein Cholesterol(HDL-C) When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks||Baseline to 8, and 16 weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||Percentage of change||Standard Error|Least Squares Mean
753839|NCT00570739|Secondary|Percent Change of Non-High Density Lipoprotein (Non-HDL) Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks||Baseline to 8, and 16 weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||percentage of change in non-HDL||Standard Error|Least Squares Mean
753871|NCT00571038|Secondary|Change in Alcohol Use|"Mean/SE change in score on:
Scale: Alcohol Use Disorders Identification Test (AUDIT) Construct: Alcohol use and abuse Minimum Score: 0 Maximum Score: 12 Interpretation of Score: Lower is better"|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.||survey score||Standard Error|Mean
753840|NCT00570739|Secondary|The Percent Change of Low Density Lipoprotein Cholesterol (LDL-C) When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks||Baseline to 8, and 16 weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||percentage of change in LDL-C||Standard Error|Least Squares Mean
753841|NCT00570739|Secondary|2 Hour Post-Meal C-Peptide Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 weeks|The No. analyzed = the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. Results are presented for both LOCF and no LOCF.||ng/mL||Standard Error|Least Squares Mean
753842|NCT00570739|Secondary|2 Hour Post-Meal Insulin Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 weeks|The No. analyzed = the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. Results are presented for both LOCF and no LOCF.||uIU/mL||Standard Error|Least Squares Mean
753843|NCT00570739|Secondary|2 Hour Post-Meal Glucose Levels to in Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 weeks|The No. analyzed = the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. Results are presented for both LOCF and no LOCF.||mg/dL||Standard Error|Least Squares Mean
753844|NCT00570739|Secondary|1 Hour Post-Meal Glucose Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 weeks|The No. analyzed = the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. Results are presented for both LOCF and no LOCF.||mg/dL||Standard Error|Least Squares Mean
753845|NCT00570739|Secondary|30 Minute Post-Meal Glucose Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 weeks|The No. analyzed = the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. Results are presented for both LOCF and no LOCF.||mg/dL||Standard Error|Least Squares Mean
753846|NCT00570739|Secondary|Fasting C-Peptide Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 weeks|The No. analyzed = the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. Results are presented for both LOCF and no LOCF.||ng/mL||Standard Error|Least Squares Mean
753847|NCT00570739|Secondary|Fasting Insulin When Given to Drug-naïve, Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks||Baseline to 4, 8, 12, and 16 weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||uIU/mL||Standard Error|Least Squares Mean
753848|NCT00570739|Secondary|Fasting Plasma Glucose When Given to Drug-naïve, Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks||Baseline to 4, 8, 12, and 16 weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||mg/dL||Standard Error|Least Squares Mean
753849|NCT00570739|Secondary|Percent Change in Hemoglobin A1C (HbA1C) When Given to Drug-naïve, Diabetic Subjects From Baseline to 4, 8, 12 and 16 Weeks.||Baseline to 4, 8, 12, and 16 weeks|The number analyzed equals the full analysis set. The full analysis set included all randomized subjects who took at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline efficacy variable measurement. This analysis set was used for the summary and analysis of all efficacy variables. LOCF was not used.||Percentage of change in HbA1c||Standard Error|Least Squares Mean
753850|NCT00570765|Secondary|Plasma Trough Concentrations of INT-747 and Its Major, Known Metabolites||12 weeks||||||
753851|NCT00570765|Secondary|Hepatocellular Injury and Liver Function: ALT|Percent change of alanine transaminase(ALT)from Baseline (Day 0) vs. Day 85/ or early termination.|Baeline and 12 weeks|||Percent change||Standard Error|Mean
753852|NCT00570765|Secondary|Hepatocellular Injury and Liver Function: GGT|Percent change of gamma-glutamyl transferase (GGT)from Baseline (Day 0) vs. Day 85/ or early termination (ET) visit.|Baeline and 12 weeks|||Percent change||Standard Error|Mean
753853|NCT00570765|Primary|Alkaline Phosphatase (AP) Levels|Percent (%) Change in Serum Alkaline Phosphatase from baseline to end of study (EOS)at Day 85.|Baseline and 12 weeks|Per Statistical Analysis Plan (SAP): patients will be analyzed by the treatment group to which they were randomly assigned - intention to treat (ITT) principle.||Percent change||Standard Error|Mean
753854|NCT00570778|Secondary|Number of Participants With Adverse Events, Serious Adverse Events and Discontinuations Due to Adverse Events|Additional information about adverse events can be found in the Adverse Event Section.|47 days|Safety population includes all participants who received at least 1 dose of study drug.||Participants|||Number
753872|NCT00571038|Secondary|Change in Satisfaction With Blood Pressure Treatment|"Mean/SE change in score on:
Scale: Modified Holmes-Ravnor Satisfaction with Decision (SWD) Construct: Satisfaction with current blood pressure treatment Minimum Score: 1 Maximum Score: 5 Interpretation of Score: Lower is better (NOTE: Original instrument's scoring is reversed; i.e., higher is better)"|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.||survey score||Standard Error|Mean
753855|NCT00570778|Secondary|Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve (AUC) 5 Minutes-12 Hours at Day 7|Spirometry testing was performed in accordance with American Thoracic Society standards. FEV1 was assessed at 5, 15, 30 minutes, 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post dose on Day 7. Standardized (with respect to time) AUC (5 minutes-12 hours) for FEV1 on day 7 was calculated using the trapezoidal rule. Least square means are based on the Analysis of Covariance: FEV1 AUC = sequence effect + patient (sequence) + period + treatment + baseline FEV1 (period) + error.|Day 7|Participants from the Modified Intent-to-treat population (includes all participants who received study drug) with data available for analysis.||Liters||Standard Error|Least Squares Mean
753856|NCT00570778|Primary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 7|Spirometry testing was performed in accordance with American Thoracic Society standards. Trough FEV1 was defined as the average of the 23 hour 15 minute and 23 hour 45 minute measurements post dosing. Baseline FEV1 is the mean of the 45 minute and 15 minute pre-dose FEV1 values at day 1 of each period. Least square means are based on the Analysis of Covariance Trough FEV1 at day 7 = sequence effect + patient(sequence) + period effect + treatment effect + (period) baseline FEV1 + error.|Baseline, Day 7|Participants from the Modified Intent-to-treat population (includes all participants who received study drug) with data available for analysis.||Liters||Standard Error|Least Squares Mean
753857|NCT00570908|Primary|Progression Free Survival|Progression free survival is defined as form initiation of WBRT with capecitabine to the time of first documented progression at any site (CNS or non-CNS site) or death due to any cause, where progression is defined stringently by progression in either CNS or extra-CNS metastases.|2 years|5 patients progressed during the study treatment. 7 patients were off study treatment early due to AE or withdrawal but 6 of them were followed for the survival outcome, 1 was lost to follow up after 3.5 months observation (censored data).||months||95% Confidence Interval|Median
753858|NCT00570921|Secondary|Clinical Benefit Rate|Clinical benefit rate is defined as a complete response, partial response, or stable disease (CR, PR, SD) by Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for a minimum of at least 24 weeks or more.|Duration of response or stable disease for 24 weeks or more|||participants|||Number
753859|NCT00570921|Secondary|Objective Response Rates|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Evaluated 60 days after therapy start|||participants|||Number
753860|NCT00570921|Primary|Time to Progression||Duration of time start of treatment to time of documented progression or death|||months||95% Confidence Interval|Median
753861|NCT00570960|Primary|30 Day All Cause Mortality|30 day all cause mortality|30 days|||participants|||Number
753862|NCT00571038|Secondary|Change in Patient Activation|"Mean/SE change in score on:
Scale: Hibbard Patient Activation Measure (PAM) Construct: Level of patient activation and engagement in health care Minimum Score: 0 Maximum Score: 100 Interpretation of Score: Lower is better (NOTE: Original instrument's scoring is reversed; i.e., higher is better)"|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.||survey score||Standard Error|Mean
753863|NCT00571038|Secondary|Change in Health Opinions|"Mean/SE change in overall score on:
Scale: Krantz Health Opinion Survey Construct: Opinions about healthcare and healthcare providers Minimum Score: 0 Maximum Score: 16 Interpretation of Score: Higher is better"|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.||survey score||Standard Error|Mean
753864|NCT00571038|Secondary|Change in Social Support|"Mean/SE change in overall score on:
Scale: Medical Outcomes Study (MOS) Social Support Survey Construct: Overall measure of social support, including tangible, affectionate, positive social interaction, and emotional/informational Minimum Score: 0 Maximum Score: 100 Interpretation of Score: Higher is better"|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.||survey score||Standard Error|Mean
753865|NCT00571038|Secondary|Change in Self Efficacy|"Mean/SE change in score on:
Scale: Schwarzer General Perceived Self-Efficacy Construct: Perceived self-efficacy Minimum Score: 10 Maximum Score: 40 Interpretation of Score: Higher is better"|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.||survey score||Standard Error|Mean
753866|NCT00571038|Secondary|Change in Medication Adherence|"Mean/SE change in score on:
Scale: Morisky Adherence; questions modified to ask specifically about blood pressure medication Construct: Adherence to prescribed medication-taking regimen Minimum Score: 0 Maximum Score: 4 Interpretation of Score: Lower is better"|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.||survey score||Standard Error|Mean
753867|NCT00571038|Secondary|Change in Fruit and Vegetable Intake|Mean/SE change in # of servings per day; questions taken from the 2009 Behavioral Risk Factor Surveillance System (BRFSS) Questionnaire|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.||servings of fruits & vegetables per day||Standard Error|Mean
753868|NCT00571038|Secondary|Change in Daily Steps|Mean/SE change in # of steps per day (self report)|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.||steps per day||Standard Error|Mean
753869|NCT00571038|Secondary|Change in Physical Activity Level|"Mean/SE change in score on:
Scale: International Physical Activity Questionnaire (IPAQ), Metabolic Equivalent of Task (MET) Construct: Total metabolic equivalents (a measure of energy expenditure) in the last 7 days Minimum Score: 0 Maximum Score: Not applicable; based on physical activity done Interpretation of Score: Higher is better"|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.||METS||Standard Error|Mean
753870|NCT00571038|Secondary|Change in Sodium Intake|"Mean/SE change in score on:
Scale: Hopkins Dietary Questionnaire (only the dietary salt avoidance questions) Construct: Dietary sodium intake Minimum Score: 2 Maximum Score: 12 Interpretation of Score: Higher is better"|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.||survey score||Standard Error|Mean
778246|NCT00775190|Secondary|Side Effects (Mood Changes)|Self reported changes in mood during each month over the time frame.|6 months|Study Terminated with no data analysis|||||
753873|NCT00571038|Secondary|Change in Hypertension Attitudes|"Mean/SE change in score on:
Scale: Not applicable; series of agree/disagree statements that we wrote Construct: Attitudes around blood pressure diagnosis, treatment (including lifestyle changes), and seriousness of the condition Minimum Score: 12 Maximum Score: 60 Interpretation of Score: Lower is better"|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.||survey score||Standard Error|Mean
753874|NCT00571038|Secondary|Change in Hypertension Knowledge|"Mean/SE change in score on:
Scale: Hypertension Evaluation of Lifestyle and Management (HELM) Construct: Knowledge of hypertension and lifestyle factors related to hypertension Minimum Score: 0 Maximum Score: 14 Interpretation of Score: Higher is better"|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.||survey score||Standard Error|Mean
753875|NCT00571038|Secondary|Change in Number of Blood Pressure Medications|Change in mean # of prescription blood pressure medications|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.||blood pressure medications||Standard Error|Mean
753876|NCT00571038|Secondary|Non-Clinic Blood Pressure Checks|% reporting non-clinic blood pressure (BP) checks at least once a month|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.||percentage of participants|||Number
753877|NCT00571038|Secondary|Change in Time Since Last Physician Visit|Change in mean # of months since last visit to a physician|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.||months (since last visit)||Standard Error|Mean
753878|NCT00571038|Secondary|Change in Health Status|"Response to the question How would you rate your general health status?. Response options are scored as follows.
Excellent
Very Good
Good
Fair
Poor We report the change in health status from baseline to 12 months."|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.||units on a scale (range 1-5)||Standard Error|Mean
753879|NCT00571038|Secondary|Change in BMI|Mean/SE change in Body Mass Index (BMI) (kg/m2)|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.||kg/m2||Standard Error|Mean
753880|NCT00571038|Secondary|Change in Weight|Mean/SE change in weight, measured in pounds (lbs)|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.||pounds||Standard Error|Mean
753881|NCT00571038|Secondary|Change in Diastolic Blood Pressure|Mean/SE change in diastolic blood pressure|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.||mm Hg||Standard Error|Mean
753882|NCT00571038|Primary|Change in Systolic Blood Pressure|Mean/Standard Error (SE) change in systolic blood pressure|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.||mm Hg||Standard Error|Mean
753883|NCT00577889|Secondary|Confirmed Response Rate|"A confirmed response is defined as a complete response (CR) or partial response (PR) observed in two consecutive evaluations at least 4 weeks apart using the Response Evaluation Criteria In Solid Tumors (RECIST). Estimated using the method of Kaplan-Meier.
Complete Response (CR): Disappearance of all target lesions and normalization of tumor biomarkers (CA 19-9 or CEA).
Partial Response (PR): At least a 30% decrease in the sum of largest dimension(LD) of target lesions taking as reference the baseline sum LD.Evaluated using RECIST criteria."|2 consecutive evaluations at least 4 weeks, up to 6 courses of treatment|||participants|||Number
753884|NCT00577889|Secondary|Time to Disease Progression|"The time to disease progression is defined as the time from registration to the time of confirmed disease progression using the Response Evaluation Criteria In Solid Tumors (RECIST). Estimated using the method of Kaplan-Meier.
Complete Response (CR): Disappearance of all target lesions and normalization of tumor biomarkers (CA 19-9 or CEA).
Partial Response (PR): At least a 30% decrease in the sum of largest dimension(LD) of target lesions taking as reference the baseline sum LD."|Time from registration to documentation of disease progression, assessed up to 2 years|||months||95% Confidence Interval|Median
753885|NCT00577889|Secondary|Overall Survival Time|Overall Survival time is defined as the time from registration to death due to any cause. Estimated using the method of Kaplan-Meier.|Assessed up to 2 years from registration|||months||95% Confidence Interval|Median
753886|NCT00577889|Primary|Six Month Survival Rate|"A patient that is alive at 6 months is considered a treatment success. Estimated by the number of successes divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner."|6 months|||percentage of patients||95% Confidence Interval|Number
753887|NCT00578071|Secondary|Pathological Complete Response Rates Associated With This Regimen.|Absence of residual viable tumor cells at the time of surgical resection of the esophagus performed 7-9 weeks following completion of chemoradiotherapy.|90 days|Surgery was determined according to risk factors, patient consent and resectability.||percentage of participants|||Number
753888|NCT00578071|Secondary|Overall Survival Rates for the Patients Studied on This Protocol.|Number of patients alive one year after completing study protocol treatment.|One year|||participants|||Number
753889|NCT00578071|Primary|Number of Participants With Dose-limiting Toxicities (DLTs)||Within 30 days of the last day of radiation|All patients who received chemoradiation.||participants|||Number
753890|NCT00578071|Primary|Panitumumab Maximum Tolerated Dose in Milligrams (mg)||60 days|Per protocol and intention to treat (ITT).||mg|||Number
753891|NCT00578136|Secondary|The Duration of Analgesia Based on Time to First Rescue Med, the Quality of Analgesia Based on Modified FACES Scale, and the Incidence of Side Effects: Nausea, Vomiting, Pruritus, and Assess Patient Satisfaction With Pain Management.|difference in time to rescue analgesic and the differences in side effects for the two groups.|immediate to 24 hours post-operatively|Time to first rescue dose of opioid medication.||minutes||Standard Deviation|Mean
753892|NCT00578136|Primary|The Amount of Intravenous and Oral Opioids Used by Patients Who Receive a Rectus Sheath Nerve Block and Those Who Receive Local Infiltration of the Surgical Site for Postoperative Analgesia.|total postoperative opioid and any additional analgesic medications.|immediate to 24 hour post-operatively|||mg kg-1||95% Confidence Interval|Mean
753893|NCT00578175|Secondary|Number of Subjects Reporting Serious Adverse Events|Serious adverse events assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|For approximately 6 months (Day 0-180)|Analysis was performed on the Total Vaccinated Cohort.||subjects|||Number
753894|NCT00578175|Secondary|Number of Subjects Reporting New Onset Chronic Illnesses and Conditions Prompting Emergency Room Visits|New onset chronic illnesses include autoimmune disorders, asthma, type I diabetes and allergies.|For approximately 6 months (Day 0-180)|Analysis was performed on the Total Vaccinated Cohort.||subjects|||Number
753895|NCT00578175|Secondary|Number of Subjects Reporting Unsolicited Adverse Events and Medically-attended Adverse Events (Excluding Rash and Parotid/Salivary Gland Swelling)|"Unsolicited adverse event covers any adverse event reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Medically-attended adverse event covers any adverse event which received medical attention. Medical attention is defined as hospitalization, an emergency room visit or a visit to or from medical personnel."|During the 43-day follow-up period after vaccination|Analysis was performed on the Total Vaccinated Cohort.||subjects|||Number
753896|NCT00578175|Secondary|Number of Subjects Reporting Investigator-confirmed Parotid/Salivary Gland Swelling||During the 43-day follow-up period after vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available results.||subjects|||Number
753897|NCT00578175|Secondary|Number of Subjects Reporting Investigator-confirmed Varicella-like Rash||During the 43-day follow-up period after vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available results.||subjects|||Number
753898|NCT00578175|Secondary|Number of Subjects Reporting Investigator-confirmed Measles/Rubella-like Rash||During the 43-day follow-up period after vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available results.||subjects|||Number
753899|NCT00578175|Secondary|Number of Subjects Reporting Fever ≥ 38.0°C/100.4°F and > 39.5°C/103.1°F During the 43-day Follow-up Period After Vaccination|Fever was measured rectally.|During the 43-day follow-up period following vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available results.||subjects|||Number
753900|NCT00578175|Secondary|Number of Subjects Reporting Fever ≥ 38.0°C/100.4°F and > 39.5°C/103.1°F During the 15-day Follow up Period After Vaccination|Fever was measured rectally.|During the 15-day follow-up period following vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available results.||subjects|||Number
753901|NCT00578175|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling.|During the 4 day follow up period following vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available results.||subjects|||Number
753902|NCT00578175|Secondary|Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value|Cut-off value assessed include 1.0 micrograms per milliliter (µg/mL).|At Day 42 after vaccination|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.||subjects|||Number
753903|NCT00578175|Secondary|Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value|Cut-off value assessed include 0.5 micrograms per milliliter (µg/mL).|At Day 42 after vaccination|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.||subjects|||Number
753904|NCT00578175|Secondary|Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value|Cut-off value assessed include 0.2 micrograms per milliliter (µg/mL).|At Day 42 after vaccination|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.||subjects|||Number
753905|NCT00578175|Secondary|Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value|Cut-off value assessed include 0.05 micrograms per milliliter (µg/mL).|At Day 42 after vaccination|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.||subjects|||Number
753906|NCT00578175|Secondary|Number of Subjects With Vaccine Response to Havrix®|Vaccine response to Havrix® is defined as the appearance post-vaccination of anti-hepatitis A virus (anti-HAV) antibodies [concentration greater than or equal to 15 milli-international units per milliliter (mIU/mL)] in the serum of subjects seronegative before vaccination (concentration below the assay cut-off value of 15 mIU/mL) or having a 2-fold increase above the pre-vaccination concentration in subjects who were seropositive before vaccination.|At Day 42 after vaccination|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.||subjects|||Number
753907|NCT00578175|Secondary|Concentration of Antibodies to Rubella Virus|Concentrations are given as Geometric Mean Concentrations (GMCs).|At Day 42 after vaccination|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.||International units per milliliter||95% Confidence Interval|Geometric Mean
753908|NCT00578175|Secondary|Concentration of Antibodies to Measles Virus|Concentrations are given as Geometric Mean Concentrations (GMCs).|At Day 42 after vaccination|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.||milli-international units per milliliter||95% Confidence Interval|Geometric Mean
753909|NCT00578175|Secondary|Antibody Titers to Mumps Virus|Data are expressed as Geometric Mean Titers (GMTs). The titer is the serum dilution giving a 50 percent reduction of the signal compared to a control without serum.|At Day 42 after vaccination|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.||titer||95% Confidence Interval|Geometric Mean
753910|NCT00578175|Primary|Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F|Concentrations are given as Geometric Mean Concentrations (GMCs).|At Day 42 after vaccination|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.||micrograms per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
755318|NCT00593606|Primary|Change in Platelet Count|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||Giga/l||Standard Deviation|Mean
753911|NCT00578175|Primary|Concentration of Antibodies to Hepatitis A Virus (HAV)|Concentrations are given as Geometric Mean Concentrations (GMCs).|At Day 42 after vaccination|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.||milli-international units per milliliter||95% Confidence Interval|Geometric Mean
753912|NCT00578175|Primary|Number of Subjects With Seroresponse for Antibodies to Rubella Virus|Seroresponse for antibodies to rubella virus is defined as the appearance post-vaccination of anti-rubella virus antibodies [concentration greater than or equal to the threshold of 10 international units per milliliter (IU/mL)] in the serum of subjects below the assay cut-off value of 4 IU/mL before vaccination.|At Day 42 after vaccination|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.||subjects|||Number
753913|NCT00578175|Primary|Number of Subjects With Seroresponse for Antibodies to Measles Virus|Seroresponse for antibodies to measles virus is defined as the appearance post-vaccination of anti-measles virus antibodies [concentration greater than or equal to the threshold of 200 milli-international units per milliliter (mIU/mL)] in the serum of subjects below the assay cut-off value of 150 mIU/mL before vaccination.|At Day 42 after vaccination|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.||subjects|||Number
753914|NCT00578175|Primary|Number of Subjects With Seroresponse for Antibodies to Mumps Virus|Seroresponse for antibodies to mumps virus is defined as the appearance post-vaccination of anti-mumps virus antibodies [titer greater than or equal to the threshold of 51 Effective Doses (ED50)] in the serum of subjects below the assay cut-off value of 24 ED50 before vaccination.|At Day 42 after vaccination|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.||subjects|||Number
753915|NCT00578175|Primary|Concentration of Antibodies to Varicella Virus (VZV)|Concentrations are given as Geometric Mean Concentrations (GMCs).|At Day 42 after vaccination|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.||milli-international units per milliliter||95% Confidence Interval|Geometric Mean
753916|NCT00578175|Primary|Number of Subjects With Seroresponse for Antibodies to Varicella Virus (VZV)|Seroresponse for antibodies to VZV is defined as the appearance post-vaccination of anti-VZV antibodies [concentration greater than or equal to the threshold of 75 milli-international units per milliliter (mIU/mL)] in the serum of subjects below the assay cut-off value of 25 mIU/mL before vaccination.|At Day 42 after vaccination|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.||subjects|||Number
753917|NCT00578214|Secondary|Pulse Oximetry at 60 Minutes|Pulse oximetry measures the oxygenation of a patient's hemoglobin. A sensor is placed on the patient’s finger. Light at red and infrared wavelengths is passed sequentially through the patient to a photodetector. The changing absorbance at each of the two wavelengths is measured, allowing determination of the absorbance. The color of the blood provides a measure of oxygenation (the percentage of hemoglobin molecules bound with oxygen molecules). A healthy young person will probably have an oxygen saturation of 95-99%.|60 minutes after drug administration|The analysis was done on the patients who completed the assessment. Three patients in the randomized midazolam arm and 3 patients in the placebo arm did not complete this assessment.||percentage of oxygenation||Standard Deviation|Mean
753918|NCT00578214|Secondary|Respiratory Rate at 60 Minutes||60 minutes after drug administration|The analysis was done on the patients who completed the assessment. Three patients in the randomized midazolam arm and 3 patients in the placebo arm did not complete this assessment.||breaths per minute||Standard Deviation|Mean
753919|NCT00578214|Secondary|Heart Rate at 60 Minutes||60 minutes after drug administration|The analysis was done on the patients who completed the assessment. Three patients in the randomized midazolam arm and 2 patients in the placebo arm did not complete this assessment.||heart beats per minute||Standard Deviation|Mean
753920|NCT00578214|Secondary|Blood Pressure at 60 Minutes||60 minutes after drug administration|The analysis was done on the patients who completed the assessment. Three patients in the randomized midazolam arm and 2 patients in the placebo arm did not complete this assessment.||mm Hg||Standard Deviation|Mean
753921|NCT00578214|Secondary|Pulse Oximetry at 30 Minutes|Pulse oximetry measures the oxygenation of a patient's hemoglobin. A sensor is placed on the patient’s finger. Light at red and infrared wavelengths is passed sequentially through the patient to a photodetector. The changing absorbance at each of the two wavelengths is measured, allowing determination of the absorbance. The color of the blood provides a measure of oxygenation (the percentage of hemoglobin molecules bound with oxygen molecules). A healthy young person will probably have an oxygen saturation of 95-99%.|30 minutes after drug administration|The analysis was done on the patients who completed the assessment. Three patients in the randomized midazolam arm and 2 patients in the placebo arm did not complete this assessment.||percentage of oxygenation||Standard Deviation|Mean
753922|NCT00578214|Secondary|Respiratory Rate at 30 Minutes||30 minutes after drug administration|The analysis was done on the patients who completed the assessment. Three patients in the randomized midazolam arm and 2 patients in the placebo arm did not complete this assessment.||breaths per minute||Standard Deviation|Mean
753923|NCT00578214|Secondary|Heart Rate at 30 Minutes||30 minutes after drug administration|The analysis was done on the patients who completed the assessment. One patient in the placebo arm did not complete this assessment.||heart beats per minute||Standard Deviation|Mean
753924|NCT00578214|Secondary|Blood Pressure at 30 Minutes||30 minutes after drug administration|||mm Hg||Standard Deviation|Mean
753925|NCT00578214|Secondary|Patient Cognitive Function at 120 Minutes|Cognitive function was measured by the Mini-Mental State Examination (MMSE), a brief 30 point questionnaire test. The scores can range from 0 (low cognitive function) to 30 (high cognitive function).|120 minutes after drug administration|The analysis was done on the patients who completed the assessment. Two patients in the placebo arm did not complete this assessment.||units on a scale||Standard Deviation|Mean
753926|NCT00578214|Secondary|Patient Cognitive Function at Baseline and 60 Minutes|Cognitive function was measured by the Mini-Mental State Examination (MMSE), a brief 30 point questionnaire test. The scores can range from 0 (low cognitive function) to 30 (high cognitive function).|baseline (prior to drug administration) and 60 minutes after drug administration|The analysis was done on the patients who completed the assessment. One patient in the prospective midazolam arm did not complete this assessment.||units on a scale||Standard Deviation|Mean
753927|NCT00578214|Primary|Patient Anxiety at 60 and 120 Minutes|A 10-point visual analog scale (VAS) was used to measure anxiety. The patients marked on the scale their feeling of anxiety. The lowest value possible was 0 (no anxiety) and the highest value possible was 10 (highest possible anxiety).|60 and 120 minutes after drug administration|The analysis was done on the patients who completed the assessment. One patient in the randomized midazolam arm did not complete this assessment.||units on a scale||Standard Deviation|Mean
753928|NCT00578214|Secondary|Patient Alertness at 60 and 120 Minutes|A 10-point visual analog scale (VAS) was used to measure alertness. The patients marked on the scale their feeling of alertness. The lowest value possible was 0 (awake) and the highest value possible was 10 (barely awake).|60 and 120 minutes after drug administration|The analysis was done on the patients who completed the assessment. One patient in the randomized midazolam arm and 1 patient in the prospective midazolam arm did not complete this assessment.||units on a scale||Standard Error|Mean
753929|NCT00578214|Secondary|Patient Alertness at Baseline|A 10-point visual analog scale (VAS) was used to measure alertness. The patients marked on the scale their feeling of alertness. The lowest value possible was 0 (awake) and the highest value possible was 10 (barely awake).|Baseline (prior to drug administration)|The analysis was done on the patients who completed the assessment. One patient in the randomized midazolam arm did not complete this assessment.||units on a scale||Standard Deviation|Mean
753930|NCT00578214|Primary|Patient Anxiety at Baseline|A 10-point visual analog scale (VAS) was used to measure anxiety. The patients marked on the scale their feeling of anxiety. The lowest value possible was 0 (no anxiety) and the highest value possible was 10 (highest possible anxiety).|Baseline (prior to drug administration)|The analysis was done on the patients who completed the assessment. One patient in the randomized midazolam arm, 2 patients in the placebo arm, and 1 patient in the prospective midazolam arm did not complete this assessment.||units on a scale||Standard Deviation|Mean
753931|NCT00578227|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Throughout the study (up to Month 12)|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.||subjects|||Number
753932|NCT00578227|Secondary|Number of Subjects Reporting Unsolicited Adverse Events|Unsolicited adverse events include any adverse event reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 30-day period following any vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.||subjects|||Number
753933|NCT00578227|Secondary|Number of Subjects Reporting Medically Significant Conditions|Medically significant conditions include adverse events (AEs) prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|Throughout the safety follow-up (from Month 7 up to Month 12)|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.||subjects|||Number
753934|NCT00578227|Secondary|Number of Subjects Reporting Medically Significant Conditions|Medically significant conditions include adverse events (AEs) prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|Throughout the active phase of the study (up to Month 7)|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.||subjects|||Number
753935|NCT00578227|Secondary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, rash, temperature [axillary route, greater than or equal to 37.5 degree Celsius (°C)] and urticaria.|During the 7-day period following vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.||subjects|||Number
753936|NCT00578227|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include injection site pain, redness and swelling. Data are presented across doses.|During the 7-day period (Day 0-6) following vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.||subjects|||Number
753937|NCT00578227|Secondary|Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibody Titers|Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL.|One month after the second dose of vaccine|Analysis was performed on a subset from the ATP cohort for analysis of immunogenicity, in subjects for which a blood sample was taken at Month 2 and were seronegative for the corresponding HPV type before vaccination, i.e. with antibody titers below 8 EL.U/mL for anti-HPV-16 antibodies and below 7 EL.U/mL for anti-HPV-18 antibodies.||EL.U/mL||95% Confidence Interval|Geometric Mean
753938|NCT00578227|Secondary|Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies|Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination. Cut-off values assessed include 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.|One month after the second dose of vaccine|Analysis was performed on a subset from the ATP cohort for analysis of immunogenicity, in subjects for which a blood sample was taken at Month 2 and were seronegative for the corresponding HPV type before vaccination, i.e. with antibody titers below 8 EL.U/mL for anti-HPV-16 antibodies and below 7 EL.U/mL for anti-HPV-18 antibodies.||subjects|||Number
753939|NCT00578227|Secondary|Anti-HBs Antibody Titers|Titers are given as geometric mean titers (GMTs) expressed as mIU/mL.|One month after the second dose of vaccine|Analysis was performed on a subset from the ATP cohort for analysis of immunogenicity, in subjects for which a blood sample was taken at Month 2 and were seronegative for anti-HBs before vaccination, i.e. with antibody titers below 3.3 mIU/mL.||mIU/mL||95% Confidence Interval|Geometric Mean
753940|NCT00578227|Secondary|Number of Subjects Seroconverted and Number of Subjects Seroprotected for Anti-HBs Antibodies|"Seroconversion is defined as the appearance of anti-HBs antibodies (i.e., antibody titer greater than or equal to 3.3 mIU/mL) in the sera of subjects seronegative (with antibody titers below 3.3 mIU/mL) before vaccination.
A seroprotected subject against HBs is a subject with antibody titers greater than or equal to 10 mIU/mL."|One month after the second dose of vaccine|Analysis was performed on a subset from the ATP cohort for analysis of immunogenicity, in subjects for which a blood sample was taken at Month 2 and were seronegative for anti-HBs with antibody titers below 3.3 mIU/mL.||subjects|||Number
753941|NCT00578227|Secondary|Anti-HAV Antibody Titers|Titers are given as geometric mean titers (GMTs) expressed as mIU/mL.|One month after the second dose of vaccine|Analysis was performed on a subset from the ATP cohort for analysis of immunogenicity, in subjects for which a blood sample was taken at Month 2 and were seronegative for anti-HAV before vaccination, i.e. with anti-HAV antibody titers below 15 mIU/mL.||mIU/mL||95% Confidence Interval|Geometric Mean
753942|NCT00578227|Secondary|Number of Subjects Seroconverted for Anti-HAV Antibodies|Seroconversion is defined as the appearance of anti-HAV antibodies (i.e., antibody titer greater than or equal to 15 mIU/mL) in the sera of subjects seronegative (antibody titer below 15 mIU/mL) before vaccination.|One month after the second dose of vaccine|Analysis was performed on a subset from the ATP cohort for analysis of immunogenicity, in subjects for which a blood sample was taken at Month 2 and were seronegative for anti-HAV before vaccination, i.e. with anti-HAV antibody titers below 15 mIU/mL.||subjects|||Number
753943|NCT00578227|Secondary|Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibody Titers in Vaccine Recipients Aged 9 Years|Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).|At Month 7|Analysis was performed in 9-year old subjects from the ATP cohort for analysis of immunogenicity, who were seronegative for the corresponding HPV type before vaccination, i.e. with antibody titers below 8 EL.U/mL for anti-HPV-16 antibodies and below 7 EL.U/mL for anti-HPV-18 antibodies.||EL.U/mL||95% Confidence Interval|Geometric Mean
753944|NCT00578227|Secondary|Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Vaccine Recipients Aged 9 Years|Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination. Cut-off values = 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.|At Month 7|Analysis was performed in 9-year old subjects from the ATP cohort for analysis of immunogenicity, who were seronegative for the corresponding HPV type before vaccination, i.e. with antibody titers below 8 EL.U/mL for anti-HPV-16 antibodies and below 7 EL.U/mL for anti-HPV-18 antibodies.||subjects|||Number
753945|NCT00578227|Secondary|Number of Subjects Seroconverted for Anti-HBs Antibodies|Seroconversion is defined as the appearance of anti-HBs antibodies (i.e., antibody titer greater than or equal to 3.3 mIU/mL) in the sera of subjects seronegative (with antibody titers below 3.3 mIU/mL) before vaccination.|At month 7|Analysis was performed on the ATP cohort for analysis of immunogenicity, in subjects seronegative for anti-HBs before vaccination.||subjects|||Number
753946|NCT00578227|Secondary|Anti-HBs Antibody Titers|Titers are given as Geometric Mean Titers (GMTs)expressed as mIU/mL.|At Month 7|Analysis was performed on the ATP cohort for analysis of immunogenicity, in subjects seronegative for anti-HBs before vaccination, i.e. with anti-HBs antibody titers below 3.3 mIU/mL.||mIU/mL||95% Confidence Interval|Geometric Mean
753947|NCT00578227|Primary|Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibody Titers|Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).|At Month 7|Analysis was performed on the ATP cohort for analysis of immunogenicity, in subjects seronegative for the corresponding HPV type before vaccination, i.e. with antibody titers below 8 EL.U/mL for anti-HPV-16 antibodies and below 7 EL.U/mL for anti-HPV-18 antibodies.||EL.U/mL||95% Confidence Interval|Geometric Mean
753948|NCT00578227|Primary|Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies|Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination. Cut-off values = 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.|At Month 7|Analysis was performed on the ATP cohort for analysis of immunogenicity, in subjects seronegative for the corresponding HPV type before vaccination, i.e. with antibody titers below 8 EL.U/mL for anti-HPV-16 antibodies and below 7 EL.U/mL for anti-HPV-18 antibodies.||subjects|||Number
753949|NCT00578227|Primary|Number of Subjects Seroprotected for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies|A subject seroprotected against HBs is a subject with antibody titers greater than or equal to 10 mIU/mL.|At Month 7|Analysis was performed on the ATP cohort for analysis of immunogenicity, in subjects seronegative for anti-HBs before vaccination, i.e. with anti-HBs antibody titer greater than or equal to 3.3 mIU/mL.||subjects|||Number
753950|NCT00578227|Primary|Anti-Heptatis A (HAV) Antibody Titers.|Titers are given as Geometric Mean Titers (GMTs) expressed as mIU/mL.|At Month 7|Analysis was performed on the ATP cohort for analysis of immunogenicity, in subjects seronegative for anti-HAV before vaccination (i.e. with antibody titer below 15 mIU/mL).||mIU/mL||95% Confidence Interval|Geometric Mean
753951|NCT00578227|Primary|Number of Subjects Seroconverted for Anti-hepatitis A (Anti-HAV) Antibodies|Seroconversion is defined as the appearance of anti-HAV antibodies [i.e., antibody titer greater than or equal to 15 milli-international units/milliliter (mIU/mL)] in the sera of subjects seronegative (antibody titer below 15 mIU/mL) before vaccination.|At Month 7|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, in subjects seronegative for anti-HAV before vaccination (i.e. with antibody titer below 15 mIU/mL).||subjects|||Number
753952|NCT00578864|Secondary|Event Free Survival in Children With High Risk Neuroblastoma Treated on This Regimen.|The first of the two events (relapse or death) was chosen to represent disease free survival|3 years|||participants|||Number
753953|NCT00578864|Secondary|Percentage of Patients Who Have Surgery After the Second Cycle of Induction Therapy|the measure is the number of patients who have surgery after two cycles of induction|2 months|||participants|||Number
753954|NCT00578864|Secondary|Overall Survival in Children With High Risk Neuroblastoma Treated on This Regimen.||3 years|number of survival||participants|||Number
753955|NCT00578864|Primary|Rate of Toxicities Associated With Cisplatin With Protracted Oral Etoposide When Administered as Up-front Window Therapy to Previously Untreated Children With High Risk Neuroblastoma.|If a patient experiences any one of the following toxicities, attributed to induction chemotherapy cycles 1, or 2, that patient will be counted as having a dose limiting toxicity. 13.2.1.1 Inability to achieve ANC > 750 by Day 35 from start of chemotherapy cycle 1 or 2 (unless documented tumor involvement of marrow) 13.2.1.2 Inability to achieve platelet count at least 75,000 by Day 35 from start of chemotherapy cycle 1 or 2 (unless documented tumor involvement of marrow) 13.2.1.3 Any Grade 2 or greater toxicity non-hematopoietic/non-mucosal (mucositis/stomatitis) that is not reversible to Grade 1 or baseline by day 21 from start of chemotherapy cycle excluding Hematopoietic toxicity Mucositis/stomatitis Anorexia, nausea, vomiting Febrile neutropenia|2 months|||participants|||Number
753956|NCT00578864|Primary|Response Rate Associated With Two Cycles of Cisplatin With Protracted Oral Etoposide When Administered as Up-front Window Therapy to Previously Untreated Children With High Risk Neuroblastoma Tumors.||2 months|||participants|||Number
753957|NCT00578877|Secondary|Percent Women With Urogenital Adverse Events.|Clinically evaluate the safety of the SILCS diaphragm used with contraceptive gel over 6 months of use.|6 months||||||
753958|NCT00578877|Primary|Percent Probability of Pregnancy Among Users of the SILCS Diaphragm Used With Contraceptive Gel Over 6 Months of Typical Use||6 months|||percent probability|||Number
753959|NCT00578903|Secondary|Number of Subjects Alive at 2 Years Post Transplant||2 years|||participants|||Number
753960|NCT00578903|Secondary|Number of Subjects Alive at 1 Year Post Transplant||1 year|||participants|||Number
753961|NCT00578903|Secondary|Number of Patients With Chronic GVHD at 2 Years Post Transplant||2 years|||participants|||Number
753962|NCT00578903|Secondary|Number of Patients With Acute GVHD at 100 Days Post Transplant||100 days|||participants|||Number
753963|NCT00578903|Secondary|Number of Patients With Engraftment Rate at 100 Days Post Transplant|Absolute neutrophil count greater than 0.5 X 10^9/ml for at least 3 days|100 days post transplant|||participants|||Number
753964|NCT00578903|Primary|Number of Subjects Alive at 100 Days Post Transplant||100 days|||participants|||Number
753965|NCT00578929|Secondary|Percent Change From Baseline in the Reflective Total Ocular Symptom Score (TOSS)|"Total Ocular Symptom Score comprised of scoring each of the following symptoms: itchy eyes and watery eyes. Each symptom was scored as a 0 (none), 1 (mild), 2 (moderate), or 3 (severe). The 2 individual symptom scores were then added together for a total ocular symptom score.
The percent change from baseline was defined as the average of the morning and evening severity scores for the sum of the assessments of the 2 individual scores averaged across all days."|Baseline through 2 weeks after randomization|||Percent change of TOSS from baseline||Standard Error|Least Squares Mean
753966|NCT00578929|Primary|Percent Change From Baseline in the Reflective Total Nasal Symptom Score (TNSS)|"Total Nasal Symptom Score comprised of scoring each of the following symptoms: runny nose, stuffy nose, itchy nose, and sneezing. Each symptom was scored as a 0 (none), 1 (mild), 2 (moderate), or 3 (severe). The 4 individual symptom scores were then added together for a total nasal symptom score.
The percent change from baseline was defined as the average of the morning and evening severity scores for the sum of the assessments of the 4 individual scores averaged across all days."|Baseline through 2 weeks after randomization|||Percent change of TNSS from baseline||Standard Error|Least Squares Mean
753967|NCT00578942|Secondary|Response|"Response Assessment included physical exam and evaluation of peripheral blood and bone marrow. There's no widely accepted criteria for response other than complete response (CR).
CR for malignant hematologic diseases is met if all the following are met for >/= 1 month:
absence of pathologic lymphadenopathy by physical and radiographic exam
absence of constitutional symptoms due to disease
Polymorphonuclear leukocyte count > 1,500/uL; platelet count >50,000/uL; and hemoglobin >10.0 g/dL
bone marrow aspirate/biopsy done after (a) through (c) have been met, >/= 30% cellularity and an absence of abnormal lymphoid nodules or cells by flow cytometry, cytogenetics, etc.
molecular markers of disease must be negative by polymerase chain reaction, Fluorescence in situ hybridization, cytogenetics etc.
CR for solid tumors requires complete resolution of disease on physical exam and radiographs. CR for marrow failure is normal white cell, platelet and hematocrit values."|1 year|Cohort of subjects on the study who actually received >/=1 donor lymphocyte infusion (DLI). DLI doses ranged from 1×104 CD3+ cells/kg to 3.27 ×108 CD3+ cells/kg. Subjects were considered for a second and third DLI 8 weeks apart if they did not have >grade 2 toxicity from the initial DLI, donor availability, and insurance approved the infusion.||participants|||Number
753968|NCT00578942|Primary|Overall Survival (OS)|Estimate overall survival rates in subjects treated with a non-myeloablative preparative regimen followed by matched related allogeneic stem cells for allogeneic transplantation.|Up to 12 years; participants were followed for the duration of the study, an average of 8 years|Subjects who completed CAMPATH regimen + 45 days, until disease progression, or death. One participant who was lost to follow-up after 14 months was not included. Participants were followed for the duration of the study, an average of 8 years.||months alive post-infusion||Full Range|Mean
753969|NCT00578942|Primary|Toxicity|Acute graft versus host disease (GVHD) was graded according to the consensus criteria and NCI common terminology criteria for adverse events (CTCAE) v2.0 or 3.0 was used for all other toxicities. Recognizing that acute GVHD pathology in the nonablative and donor lymphocyte infusion (DLI) setting may occur late, we tabulated skin, gut and liver toxicity consistent with acute GVHD (aGVHD) at anytime in the year following the infusion as aGVHD. Toxicities were formally recorded for all patients twice weekly for the first 100 days, at each follow up visit, and as needed intercurrently.|1 year|Cohort of subjects who received >/=1 donor lymphocyte infusion (DLI). DLI doses thus ranged from 1×104 CD3+ cells/kg to 3.27 ×108 CD3+ cells/kg.Subjects were grouped into 4 categories within the range of cell doses delivered and were considered evaluable from the day of first donor lymphocyte (DLI) infusion. Results are not exclusive.||participants|||Number
753970|NCT00578968|Secondary|Percent Change in Peak Exercise HR Between Pretreatment in First Study Period and Post-treatment in Second Study Period|Heart rate is the number of heartbeats per unit of time, typically expressed as beats per minute (bpm). Percentage change = final value - initial value/initial value x 100|first visit of first study period, first visit of second study period (approximately 6 weeks later)|Normal control population did not take part in this measurement.||percentage of change in HR||Standard Deviation|Mean
778247|NCT00775190|Secondary|Side Effects (Breast Tenderness)|Incidence of breast tenderness during the study time frame|6 Months|Study Terminated with no data analysis|||||
753971|NCT00578968|Secondary|Percent Change in Peak Exercise SVI Between Pretreatment in First Study Period and Post-treatment in Second Study Period|Stroke volume - the volume of blood ejected from a ventricle at each beat of the heart, equal to the difference between the end-diastolic volume and the end-systolic volume. The stroke volume index is a method of relating the stroke volume to the size of the person by dividing the stroke volume by the BSA (m^2). Percentage change = final value - initial value/initial value x 100|first visit of first study period, first visit of second study period (approximately 6 weeks later)|Normal control population did not take part in this measurement.||percentage of change in SVI||Standard Deviation|Mean
753972|NCT00578968|Primary|Pretreatment Peak Exercise SVI|Stroke volume - the volume of blood ejected from a ventricle at each beat of the heart, equal to the difference between the end-diastolic volume and the end-systolic volume. The stroke volume index is a method of relating the stroke volume to the size of the person by dividing the stroke volume by the BSA (m^2).|first visit of first study period|Normal Control population did not take part in this measurement. Researchers collected this data V1 study period 1, but randomized subjects after V4 study period 1.||mL/m^2||Standard Deviation|Mean
753973|NCT00578968|Secondary|Percent Change in Peak Exercise CI Between Pretreatment in First Study Period and Post-treatment in Second Study Period|Cardiac index (CI): A cardiodynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area (m^2) to yield the cardiac index. Percentage change = final value - initial value/initial value x 100|first visit of first study period, first visit of second study period (approximately 6 weeks later)|Normal control population did not take part in this measurement.||percentage of change in CI||Standard Deviation|Mean
753974|NCT00578968|Primary|Pretreatment Peak Exercise CI|Cardiac index (CI): A cardiodynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area (m^2) to yield the cardiac index.|first visit of first study period|Normal Control population did not take part in this measurement. Researchers collected this data V1 study period 1, but randomized subjects after V4 study period 1.||L/min/m^2||Standard Deviation|Mean
753975|NCT00578968|Secondary|Percent Change in Peak Exercise VO_2 Between Pretreatment in First Study Period and Post-treatment in Second Study Period|VO_2 is the maximum capacity of an individual's body to transport and use oxygen during incremental exercise. Percentage change = final value - initial value/initial value x 100|first visit of first study period, first visit of second study period (approximately 6 weeks later)|Normal Control population did not take part in this measurement.||percentage of change in VO_2||Standard Deviation|Mean
753976|NCT00578968|Secondary|Pretreatment Peak Exercise Maximal Oxygen Consumption (VO_2)|VO_2 is the maximum capacity of an individual's body to transport and use oxygen during incremental exercise.|first visit of first study period|Normal Control population did not take part in this measurement. Researchers collected this data V1 study period 1, but randomized subjects after V4 study period 1.||L/min||Standard Deviation|Mean
753977|NCT00578968|Secondary|Percent Change in Resting HR Between Pretreatment in First Study Period and Post-treatment in Second Study Period|Heart rate is the number of heartbeats per unit of time, typically expressed as beats per minute (bpm). Percentage change = final value - initial value/initial value x 100|first visit of first study period, first visit of second study period (approximately 6 weeks later)|Normal control population did not take part in this measurement.||Percentage of change in HR||Standard Deviation|Mean
753978|NCT00578968|Secondary|Pretreatment Heart Rate (HR) in Tiotropium and Placebo Groups|Heart rate is the number of heartbeats per unit of time, typically expressed as beats per minute (bpm). Heart rate was measured in the first study period prior to the intervention at resting and at peak exercise states.|first study visit of first study period|Normal Control population did not take part in this measurement. Researchers collected this data V1 study period 1, but randomized subjects after V4 study period 1.||bpm||Standard Deviation|Mean
753979|NCT00578968|Secondary|Percent Change in Resting SVI Between Pretreatment in First Study Period and Post-treatment in Second Study Period|Stroke volume - the volume of blood ejected from a ventricle at each beat of the heart, equal to the difference between the end-diastolic volume and the end-systolic volume. The stroke volume index is a method of relating the stroke volume to the size of the person by dividing the stroke volume by the BSA (m^2). Percentage change = final value - initial value/initial value x 100|first visit of first study period, first visit of second study period (approximately 6 weeks later)|Normal controls did not take part in this measurement.||Percentage of change in SVI||Standard Deviation|Mean
753980|NCT00578968|Secondary|Pretreatment Resting SVI|Stroke volume - the volume of blood ejected from a ventricle at each beat of the heart, equal to the difference between the end-diastolic volume and the end-systolic volume. The stroke volume index is a method of relating the stroke volume to the size of the person by dividing the stroke volume by the BSA (m^2).|first study visit of first study period|Normal Control population did not take part in this measurement. Researchers collected this data V1 study period 1, but randomized subjects after V4 study period 1.||mL/m^2||Standard Deviation|Mean
753981|NCT00578968|Secondary|Percent Change in Resting CI Between Pretreatment in First Study Period and Post-treatment in Second Study Period|Cardiac index (CI): A cardiodynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area (m^2) to yield the cardiac index. Percentage change = final value - initial value/initial value x 100|first visit of first study period, first visit of second study period (approximately 6 weeks later)|Normal controls did not take part in this measurement.||percentage of change in CI||Standard Deviation|Mean
753982|NCT00578968|Secondary|Pretreatment Resting CI|Cardiac index (CI): A cardiodynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area (m^2) to yield the cardiac index.|first study visit of first study period|Normal Control population did not take part in this measurement. Researchers collected this data V1 study period 1, but randomized subjects after V4 study period 1.||L/min/m^2||Standard Deviation|Mean
778248|NCT00775190|Secondary|Side Effects (Vomiting)|Number of episodes of vomitting|6 Months|Study Terminated with no data analysis|||||
753983|NCT00578968|Secondary|Percent Change in Resting FEV_1 Between Pretreatment in First Study Period and Post-treatment in Second Study Period|FEV_1 is the volume exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity. Percentage change = final value - initial value/initial value x 100|first visit of first study period, first visit of second study period (approximately 6 weeks later)|Normal controls did not take part in this measurement.||Percentage of change in FEV_1||Standard Deviation|Mean
753984|NCT00578968|Secondary|Pretreatment Resting FEV_1|FEV_1 is the volume exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity.|first study visit of first study period|Normal Control population did not take part in this measurement. Researchers collected this data V1 study period 1, but randomized subjects after V4 study period 1.||L/sec||Standard Deviation|Mean
753985|NCT00578968|Secondary|Percent Change in Resting FVC Between Pretreatment in First Study Period and Post-treatment in Second Study Period|Vital capacity is the maximum amount of air a person can expel from the lungs after a maximum inspiration. A person's vital capacity can be measured by a spirometer which can be a wet or regular spirometer. In combination with other physiological measurements, the vital capacity can help make a diagnosis of underlying lung disease. Percentage change = final value - initial value/initial value x 100|first visit of first study period, first visit of second study period (approximately 6 weeks later)|Normal Control population did not take part in this measurement.||percentage of change in FVC||Standard Deviation|Mean
753986|NCT00578968|Secondary|Pretreatment Resting FVC as Percentage of Predicted FVC|Predicted normal values for vital capacity can be calculated online (based on previous research) and depends on age, sex, height, weight and ethnicity. Percentage was calculated by observed FVC/predicted FVC X 100.|First visit of first period|Normal Control population did not take part in this measurement. Researchers collected this data V1 study period 1, but randomized subjects after V4 study period 1.||percentage of predicted FVC||Standard Deviation|Mean
753987|NCT00578968|Primary|Baseline Resting Stroke Volume Index (SVI)|Stroke volume - the volume of blood ejected from a ventricle at each beat of the heart, equal to the difference between the end-diastolic volume and the end-systolic volume. The stroke volume index is a method of relating the stroke volume to the size of the person by dividing the stroke volume by the body surface area (BSA) (m^2).|first visit of first study period|||mL/m^2||Standard Deviation|Mean
753988|NCT00578968|Primary|Baseline Resting Cardiac Index (CI)|Cardiac index: A cardiodynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area (m^2) to yield the cardiac index.|First visit of first study period|||L/min/m^2||Standard Deviation|Mean
753989|NCT00578968|Secondary|Pretreatment Resting Forced Vital Capacity (FVC)|Vital capacity is the maximum amount of air a person can expel from the lungs after a maximum inspiration. A person's vital capacity can be measured by a spirometer which can be a wet or regular spirometer. In combination with other physiological measurements, the vital capacity can help make a diagnosis of underlying lung disease.|First study visit of first study period|Normal Control population did not take part in this measurement. Researchers collected this data V1 study period 1, but randomized subjects after V4 study period 1.||Liters||Standard Deviation|Mean
753990|NCT00578968|Secondary|Baseline Peak Exercise Stroke Volume Index (SVI)|Stroke volume - the volume of blood ejected from a ventricle at each beat of the heart, equal to the difference between the end-diastolic volume and the end-systolic volume. The stroke volume index is a method of relating the stroke volume to the size of the person by dividing the stroke volume by the BSA (m^2).|second visit of first study period|||mL/m^2||Standard Deviation|Mean
753991|NCT00578968|Secondary|Baseline Peak Exercise Cardiac Index (CI)|Cardiac index: A cardiodynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area (m^2) to yield the cardiac index.|second visit of first study period|||L/min/m^2||Standard Deviation|Mean
753992|NCT00578968|Secondary|Baseline Peak Exercise Maximal Oxygen Consumption (VO_2)|VO_2 is the maximum capacity of an individual's body to transport and use oxygen during incremental exercise.|second visit of first study period|||L/min||Standard Deviation|Mean
753993|NCT00578968|Secondary|Baseline Heart Rate (HR) for All COPD Participants Versus Healthy Control Groups|Heart rate is the number of heartbeats per unit of time, typically expressed as beats per minute (bpm). Heart rate was measured in the first study period prior to the intervention at resting and at peak exercise states.|first visit of first study period, second visit of first study period|||beats per minute (bpm)||Standard Deviation|Mean
753994|NCT00578968|Secondary|Baseline Resting FEV_1 as Percentage of Predicted FEV_1|Predicted normal values for Forced Expiratory Volume in 1 second can be calculated online (based on previous research) and depends on age, sex, height, weight and ethnicity. Percentage was calculated by observed FEV_1/predicted FEV_1 X 100.|first visit of first study period|||percentage of predicted FEV_1||Standard Deviation|Mean
753995|NCT00578968|Secondary|Baseline Resting Forced Expiratory Volume in 1 Second (FEV_1)|FEV_1 is the volume exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity.|first visit of first study period|||L/sec||Standard Deviation|Mean
753996|NCT00578968|Secondary|Baseline Resting FVC as Percentage of Predicted Forced Vital Capacity (FVC)|Predicted normal values for vital capacity can be calculated online (based on previous research) and depends on age, sex, height, weight and ethnicity. Percentage was calculated by observed FVC/predicted FVC X 100.|First visit of first study period|||percentage of predicted FVC||Standard Deviation|Mean
753997|NCT00578968|Secondary|Baseline Resting Forced Vital Capacity (FVC)|Vital capacity is the maximum amount of air a person can expel from the lungs after a maximum inspiration. A person's vital capacity can be measured by a spirometer which can be a wet or regular spirometer. In combination with other physiological measurements, the vital capacity can help make a diagnosis of underlying lung disease.|First visit of first study period|All COPD participants were included, prior to randomization in the second period of the study.||Liters||Standard Deviation|Mean
753998|NCT00579059|Secondary|Range of Motion - Flexion|This represents how far the patients were able to flex the knee in the clinic at 1-year.|1 Year|This population represents patients that returned for follow-up at 1-year post-op per protocol.||degrees||Full Range|Mean
753999|NCT00579059|Primary|Knee Society Function Score|"The function score is detailed below as a Range; 100 being the highest score, and 0 being the lowest score. 90-100 is considered Excellent, 60-89 is considered Good, 30-59 is considered fair, and 0-29 is considered poor."|1 Year|This population represents patients that returned for follow-up at 1-year post-op per protocol.||knees|||Number
754000|NCT00579098|Secondary|Change in Lipid Levels|The change from baseline to 3 months in blood cholesterol levels (total cholesterol, LDL or low-density lipoprotein and HDL or high-density lipoprotein) was calculated.|Baseline and 3 months|Intent-to-treat analysis population.||mg/dL||Standard Deviation|Mean
754001|NCT00579098|Secondary|Change in Mean Quality of Life Score|A visual analogue scale (VAS) was used to collect the subject's perception of their current state of health/quality of life. The VAS consists of a vertical 20 centimeter scored line (like a thermometer) with the ends labelled best imaginable health state at the top (100) and worst imaginable health state at the bottom (0). The subject marked a single line to grade his/her own current level of function at the baseline visit and again at the 3 month visit. The average change in VAS score from baseline to 3 months later is reported for each treatment group.|Baseline and 3 months|Intent-to-treat analysis population.||units on a scale||Standard Deviation|Mean
754002|NCT00579098|Secondary|Change in Mean C-Reactive Protein Level||Baseline and 3 months|Intent-to-treat analysis population.||mg/dL||Standard Deviation|Mean
754003|NCT00579098|Secondary|Percentage of Subjects Without Atrial Arrhythmia at 3 Months|Percentage of subjects without atrial arrhythmia (as opposed to atrial fibrillation) recurrence, irrespective of symptoms. Atrial arrhythmias included AF, atrial tachycardia and atrial flutter.|Baseline through 3 months|Intent-to-treat analysis population.||Percentage of subjects|||Number
754004|NCT00579098|Primary|Percentage of Subjects Without Symptoms of Atrial Fibrillation at 3 Months|Asymptomatic recurrence was defined as any atrial arrhythmia lasting more than 30 seconds. This was assessed by an electrocardiogram (ECG) and 72-hour Holter monitor recordings. At the end of the study, 336 ECG and Holter recordings were available for analysis (172 in the atorvastatin group and 164 in the placebo group).|Baseline through 3 months|Intent-to-treat analysis population.||Percentage of subjects|||Number
754005|NCT00579111|Secondary|Number of Patients With Treatment Related Grade III or IV Non-hematological Toxicity||100 days|||participants|||Number
754006|NCT00579111|Primary|Number of Patients With Successful Donor Engraftment|Each patient will be classified as a success or failure. A success will be defined as engraftment of at least 35% of cells 100 days after transplant.|100 days|||participants|||Number
754007|NCT00579137|Secondary|Number of Patients With Grade III to IV Acute GVHD||100 days|||participants|||Number
754008|NCT00579137|Secondary|Number of Patients With Grade III or IV Toxicity||100 days|||participants|||Number
754009|NCT00579137|Secondary|Patients Alive at 1 Year||1 Year|||participants|||Number
754010|NCT00579137|Primary|Number of Patients With Donor Engraftment||100 Days|||participants|||Number
754011|NCT00579254|Primary|Change in Systolic and Diastolic Blood Pressure|No efficacy results were available from this terminated study.|Baseline, 24 weeks|||mmHg (millimeters of mercury)||Standard Deviation|Mean
754012|NCT00579345|Primary|Immunogenicity Assessment by Geometric Mean Titers (GMT).|Non-inferiority of the influenza vaccine FLU (cell-culture derived seasonal trivalent influenza vaccine (cTIV); and influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a)) when administered alone versus administered concomitantly with pneumococcal vaccine (FLU + PV) is met if lower limit of the 2-sided 95% confidence interval (CI) of postvaccination (Day 22) Geometric Mean Titer ratio (FLU+PV/FLU) is greater than 0.5.|Three weeks postvaccination|Per protocol set: this population consisted of all subjects in the Intention To Treat population (ITT) who had no major protocol violation as defined prior to analysis (ITT=enrolled subjects who received single dose of influenza vaccine(or 2 vaccines if receiving the pneumococcal vaccine) and provided one serum sample before and one after baseline)||Titers||95% Confidence Interval|Geometric Mean
754013|NCT00579345|Secondary|Geometric Mean Ratio (GMR Day 22/Day1) After Single Dose of Influenza Vaccine.|"Immunogenicity (geometric mean titer ratio) of cell cultured and egg based trivalent influenza vaccine three weeks after a single injection, by the measurement of strain-specific hemagglutination inhibition (HI) tests according to the CHMP criteria (CPMP/BWP/214/96).
CHMP Criteria fulfilled if the Geometric Mean titer Ratio (GMR) is > 2.5."|Three weeks postvaccination|Per Protocol||Ratio||95% Confidence Interval|Geometric Mean
754014|NCT00579345|Secondary|Number of Subjects With Antibody Response as Assessed by Hemagglutination Inhibition Assay.|"Immunogenicity (seroconversion or significant increase in antibody titer and HI titer ≥1:40) of cell cultured and egg based trivalent influenza vaccine three weeks after a single injection, by the measurement of strain-specific hemagglutination inhibition (HI) tests according to the Committee for Medicinal Products for Human Use (CHMP) criteria (CPMP/BWP/214/96).
Seroconversion was defined as negative pre-vaccination titer (<10)/postvaccination titer ≥40. Significant increase in antibody titer was defined as at least a fourfold increase from non-negative baseline (≥10)."|Three weeks postvaccination|Per Protocol Set||Subjects|||Number
754015|NCT00579345|Primary|Number of Randomized Participants Reporting Local and Systemic Reactions.|Safety and tolerability evaluation of influenza vaccines, within one week of single intramuscular injection. Local reactions reported for Influenza Vaccine Injection site.|One week postvaccination|Safety set: this population consisted of all subjects who were vaccinated and who had some post-baseline safety data.||Subjects|||Number
754016|NCT00579345|Secondary|Number of Randomized Participants Reporting Local and Systemic Reactions.|Safety and tolerability evaluation, within one week of single intramuscular injection of influenza vaccines (cell-culture derived seasonal trivalent influenza vaccine (cTIV) or influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a) when administered alone or concomitantly with a pneumococcal vaccine (PV)). Local reactions reported for Influenza Vaccine Injection Site.|One week postvaccination|Safety Set||Subjects|||Number
754017|NCT00579345|Secondary|Number of Unrandomized Participants Reporting Local and Systemic Reactions.|Safety and tolerability evaluation of influenza vaccines, within one week of single intramuscular injection.|One week postvaccination|Safety set.||Subjects|||Number
754392|NCT00581399|Secondary|Duration of Mediastinal Drainage|The outcome to measure is the duration of the chest tubes inserted in the patient in hours. The time starts at the time the chest is completely closed and the end time when the chest tubes are pulled out of the patient's chest.|Immediate postoperative when the chest is completely closed to the time chest tubes are pulled out of the patient|||Hours||Standard Deviation|Mean
754018|NCT00579501|Secondary|Percentage of Participants With Objective Tumor Response Based on Response Evaluation Criteria In Solid Tumors (RECIST)|The objective tumor response is defined as the percentage of participants achieving partial response (PR) on tumor response assessed by RECIST. The PR is at least 30 percent decrease in sum of the longest diameter of target lesions or persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.|Every 6 weeks until disease progression (up to Week 33) or 6 months post surgery.|Participants who received at least one cycle of trabectedin and have at least one post baseline disease assessment.||percentage of participants|||Number
754019|NCT00579501|Primary|Percentage of Participants With Pathological Complete Response (pCR)|Complete pathological response is complete disappearance of the tumor tissue up to the molecular level.|Every 6 weeks until disease progression (up to Week 33) or 6 months post surgery.|Participants who received at least one cycle of trabectedin and have adequate pre and post trabectedin pathologic specimens available. Six participants were non evaluable for pCR assessment.||percentage of participants|||Number
754020|NCT00579670|Post-Hoc|Number of Participants Continuing Treatment With Ziprasidone Following Completion of the Observation Period: Within SmPC||Week 12|Within SmPC||Participants|||Number
754021|NCT00579670|Post-Hoc|Percent Change From Baseline to Final Visit in Body Weight: Within SmPC||Baseline, Week 12|Within SmPC||percent change||Standard Deviation|Mean
754022|NCT00579670|Post-Hoc|"Number of Participants Answering the Question Taking All Things Into Account, How Satisfied or Dissatisfied Are You With This Medication?: Within SmPC"||Week 12|Within SmPC; N=participants with evaluable data for specified question at observation||Participants|||Number
754023|NCT00579670|Post-Hoc|"Number of Participants Answering the Question How Certain Are You That the Good Things About Your Medication Outweigh the Bad Things?: Within SmPC"||Week 12|Within SmPC; N=participants with evaluable data for specified question at observation||Participants|||Number
754024|NCT00579670|Post-Hoc|"Number of Participants Answering the Question Overall, How Confident Are You That Taking This Medication is a Good Thing?: Within SmPC"||Week 12|Within SmPC; N=participants with evaluable data for specified question at observation||Participants|||Number
754025|NCT00579670|Post-Hoc|"Number of Participants Answering the Question How Convenient or Inconvenient is it to Take the Medication as Instructed?: Within SmPC"||Week 12|Within SmPC; N=participants with evaluable data for specified question at observation||Participants|||Number
754026|NCT00579670|Post-Hoc|"Number of Participants Answering the Question How Easy or Difficult is it to Plan When You Will Use the Medication Each Time?: Within SmPC"||Week 12|Within SmPC; N=participants with evaluable data for specified question at observation||Participants|||Number
754027|NCT00579670|Post-Hoc|"Number of Participants Answering the Question How Easy or Difficult is it to Use the Medication in Its Current Form?: Within SmPC"||Week 12|Within SmPC; N=participants with evaluable data for specified question at observation||Participants|||Number
754028|NCT00579670|Post-Hoc|"Number of Participants Answering the Question To What Degree Have Medication Side Effects Affected Your Overall Satisfaction With the Medication?: Within SmPC"||Week 12|Within SmPC; N=participants with evaluable data for specified question at observation||Participants|||Number
754029|NCT00579670|Post-Hoc|"Number of Participants Answering the Question To What Extent do the Side Effects Interfere With Your Mental Function (ie, Ability to Think, Stay Awake, Etc)?: Within SmPC"||Week 12|Within SmPC; N=participants with evaluable data for specified question at observation||Participants|||Number
754030|NCT00579670|Post-Hoc|"Number of Participants Answering the Question To What Extent do the Side Effects Interfere With Your Physical Health and Ability to Function (ie, Ability to Think Clearly, Stay Awake, Etc)?: Within SmPC"||Week 12|Within SmPC; N=participants with evaluable data for specified question at observation||Participants|||Number
754031|NCT00579670|Post-Hoc|"Number of Participants Answering the Question How Bothersome Are the Side Effects of the Medication You Take to Treat Your Condition?: Within SmPC"||Week 12|Within SmPC; N=participants with evaluable data for specified question at observation||Participants|||Number
754032|NCT00579670|Post-Hoc|"Number of Participants Answering the Question As a Result of Taking This Medication, do You Experience Any Side Effects at All?: Within SmPC"||Week 12|Within SmPC; N=participants with evaluable data for specified question at observation||Participant|||Number
754033|NCT00579670|Post-Hoc|"Number of Participants Answering the Question How Satisfied or Dissatisfied Are You With the Amount of Time it Takes the Medication to Start Working?: Within SmPC"||Week 12|Within SmPC; N=participants with evaluable data for specified question at observation||Participants|||Number
754034|NCT00579670|Post-Hoc|"Number of Participants Answering the Question How Satisfied or Dissatisfied Are You With the Way the Medication Relieves Your Symptoms?: Within SmPC"||Week 12|Within SmPC; N=participants with evaluable data for specified question at observation||Participants|||Number
754035|NCT00579670|Post-Hoc|"Number of Participants Answering the Question How Satisfied or Dissatisfied Are You With the Ability of the Medication to Prevent or Treat Your Condition?: Within SmPC"||Week 12|Within SmPC; N=participants with evaluable data for specified question at observation||Participants|||Number
754036|NCT00579670|Post-Hoc|PANSS - Composite Subscale: Within SmPC|The modified composite subscale total was calculated as the difference of the positive subscale total (7 items; total possible score of 49) and the negative subscale total (7 items; total possible score of 49). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The composite subscale total provided an indication of the level of dominance of the symptoms of one subscale over the symptoms of the other subscale. Higher scores indicated greater severity of symptoms.|Baseline, Week 12|Within SmPC; N=participants with evaluable data at observation||Scores on a scale||Standard Deviation|Mean
754037|NCT00579670|Post-Hoc|PANSS - Negative Subscale: Within SmPC|Modified negative subscale: assesses negative symptoms associated with schizophrenia. 7 items make up the Negative scale (eg, blunted affect, emotional withdrawal, poor rapport, and passive/apathetic social withdrawal). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total Negative Subscale scores range from 7 to 49. This negative subscale total was calculated as the sum of 4 items in the negative subscale.|Baseline, Week 12|Within SmPC; N=participants with evaluable data at observation||Scores on a scale||Standard Deviation|Mean
755521|NCT00594425|Secondary|Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain|Measure was assessed on a Visual Analogue Scale from 0 to 10 cm|immediately after second treatment|Safety||cm||Full Range|Mean
754038|NCT00579670|Post-Hoc|Positive and Negative Syndrome Scale (PANSS) - Positive Subscale: Within SmPC|Modified positive subscale: clinician-rated measurement that consists of 30 items, each rated from 1 (absent) to 7 (extreme). Positive subscale (ranging from 4 to 28) taking the sum of the following 4 items: P1, delusions; P2, conceptual disorganization; P3, hallucinatory behavior; and P6, suspiciousness/persecution. Higher scores indicated greater severity of symptoms. The positive subscale total was calculated as the sum of the 4 items in the positive subscale.|Baseline, Week 12|Within SmPC; N=participants with evaluable data at observation||Scores on a scale||Standard Deviation|Mean
754039|NCT00579670|Post-Hoc|Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S): Within SmPC|CGI-S: 7-point clinician rated scale to assess severity of subject's current illness state; range: 0 (not assessed) to 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. B = Baseline; F = Final Visit (Week 12)|Baseline, Week 12|Within SmPC||Participants|||Number
754040|NCT00579670|Post-Hoc|Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I): Within Summary of Product Characteristics Population (SmPC)|CGI-I: 7-point clinician rated scale ranging from 0 (not assessed) to 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Week 12|Within SmPC population: participants in FAS population who received all doses within SmPC. Within SmPC defined as all PO doses up to and including 160 mg per day and all IM doses up to and including 40 mg per day.||Participants|||Number
754041|NCT00579670|Secondary|Percent Change From Baseline to Final Visit in Body Weight||Baseline, Week 12|Safety population = all subjects who received at least 1 dose of study medication.||percent change||Standard Deviation|Mean
754042|NCT00579670|Other Pre-specified|Number of Participants Continuing Treatment With Ziprasidone Following Completion of the Observation Period||Week 12|FAS. Four subjects did not answer the question of continuation of treatment.||Participants|||Number
754043|NCT00579670|Secondary|"Number of Participants Answering the Question Taking All Things Into Account, How Satisfied or Dissatisfied Are You With This Medication?"||Week 12|FAS||Participants|||Number
754044|NCT00579670|Secondary|"Number of Participants Answering the Question How Certain Are You That the Good Things About Your Medication Outweigh the Bad Things?"||Week 12|FAS||Participants|||Number
754045|NCT00579670|Secondary|"Number of Participants Answering the Question Overall, How Confident Are You That Taking This Medication is a Good Thing?"||Week 12|FAS||Participants|||Number
754046|NCT00579670|Secondary|"Number of Participants Answering the Question How Convenient or Inconvenient is it to Take the Medication as Instructed?"||Week 12|FAS||Participants|||Number
754047|NCT00579670|Secondary|"Number of Participants Answering the Question How Easy or Difficult is it to Plan When You Will Use the Medication Each Time?"||Week 12|FAS||Participants|||Number
754048|NCT00579670|Secondary|"Number of Participants Answering the Question How Easy or Difficult is it to Use the Medication in Its Current Form?"||Week 12|FAS||Participants|||Number
754049|NCT00579670|Secondary|"Number of Participants Answering the Question To What Degree Have Medication Side Effects Affected Your Overall Satisfaction With the Medication?"||Week 12|FAS||Participants|||Number
754050|NCT00579670|Secondary|"Number of Participants Answering the Question To What Extent do the Side Effects Interfere With Your Mental Function (ie, Ability to Think, Stay Awake, Etc)?"||Week 12|FAS||Participants|||Number
754051|NCT00579670|Secondary|"Number of Participants Answering the Question To What Extent do the Side Effects Interfere With Your Physical Health and Ability to Function (ie, Ability to Think Clearly, Stay Awake, Etc)?"||Week 12|FAS||Participants|||Number
754052|NCT00579670|Secondary|"Number of Participants Answering the Question How Bothersome Are the Side Effects of the Medication You Take to Treat Your Condition?"||Week 12|||Participants|||Number
754053|NCT00579670|Secondary|"Number of Participants Answering the Question As a Result of Taking This Medication, do You Experience Any Side Effects at All?"||Week 12|||Participant|||Number
754054|NCT00579670|Secondary|"Number of Participants Answering the Question How Satisfied or Dissatisfied Are You With the Amount of Time it Takes the Medication to Start Working?"||Week 12|FAS||Participants|||Number
754055|NCT00579670|Secondary|"Number of Participants Answering the Question How Satisfied or Dissatisfied Are You With the Way the Medication Relieves Your Symptoms?"||Week 12|||Participants|||Number
754056|NCT00579670|Secondary|"Number of Participants Answering the Question How Satisfied or Dissatisfied Are You With the Ability of the Medication to Prevent or Treat Your Condition?"||Week 12|FAS||Participants|||Number
754057|NCT00579670|Secondary|PANSS - Composite Subscale|The modified composite subscale total was calculated as the difference of the positive subscale total (7 items; total possible score of 49) and the negative subscale total (7 items; total possible score of 49). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The composite subscale total provided an indication of the level of dominance of the symptoms of one subscale over the symptoms of the other subscale. Higher scores indicated greater severity of symptoms.|Baseline, Week 12|FAS||Scores on a scale||Standard Deviation|Mean
754058|NCT00579670|Secondary|PANSS - Negative Subscale|Modified negative subscale: assesses negative symptoms associated with schizophrenia. 7 items make up the Negative scale (eg, blunted affect, emotional withdrawal, poor rapport, and passive/apathetic social withdrawal). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total Negative Subscale scores range from 7 to 49. This negative subscale total was calculated as the sum of 4 items in the negative subscale.|Baseline, Week 12|FAS||Scores on a scale||Standard Deviation|Mean
754059|NCT00579670|Secondary|Positive and Negative Syndrome Scale (PANSS) - Positive Subscale|Modified positive subscale: clinician-rated measurement that consists of 30 items, each rated from 1 (absent) to 7 (extreme). Positive subscale (ranging from 4 to 28) taking the sum of the following 4 items: P1, delusions; P2, conceptual disorganization; P3, hallucinatory behavior; and P6, suspiciousness/persecution. Higher scores indicated greater severity of symptoms. The positive subscale total was calculated as the sum of the 4 items in the positive subscale.|Baseline, Week 12|FAS||Scores on a scale||Standard Deviation|Mean
754393|NCT00581399|Primary|Amount of Postoperative Bleeding|The outcome is to measure the amount of postoperative bleeding in cardiac surgery patients from the time the chest is completely closed until the chest tube is pulled out.|24-48 hours post surgery|||mL||Standard Deviation|Mean
754060|NCT00579670|Secondary|Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)|CGI-S: 7-point clinician rated scale to assess severity of subject's current illness state; range: 0 (not assessed) to 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. B = Baseline; F = Final Visit (Week 12)|Baseline, Week 12|FAS; Baseline Visit: 1 subject in the Ziprasidone >=160mg group had missing severity result. Final Visit: 2 subjects (1 subject in the Ziprasidone 120mg to <160mg and 1 subject in the Ziprasidone <80mg group) had missing severity results.||Participants|||Number
754061|NCT00579670|Secondary|Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)|CGI-I: 7-point clinician rated scale ranging from 0 (not assessed) to 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Week 12|The Full Analysis Set (FAS) - all subjects who received at least 1 dose of study medication and have at least 1 efficacy measurement.||Participants|||Number
754062|NCT00579670|Primary|Summary of Most Frequently Used Concomitant Drug Treatments|Most frequently concomitant drug treatments used by >15 participants.|Baseline|All subjects randomized to a treatment group were included in this baseline analysis.||Participants|||Number
754063|NCT00579670|Primary|Summary of Metabolic Risk Factors||Baseline|All subjects randomized to a treatment group were included in this baseline analysis.||Participants|||Number
754064|NCT00579670|Primary|Summary of Schizophrenia|Stage, symptoms and type of schizophrenia were recorded in addition to demographic and other clinical history data at the Baseline visit. The primary outcome was to assess the participants profile. Some assessments have been included in the Baseline demographics. This outcome presents results for the Summary of Schizophrenia.|Baseline|All subjects randomized to a treatment group were included in the Baseline analysis.||Participants|||Number
754065|NCT00579813|Primary|Changes in Fat Inflammation Following Pioglitazone|macrophages in fat at baseline, in lean and obese participants, and obese after pioglitazone (in obese)|Baseline and 10 weeks|||macrophages per mm2 by CD68 staining||Standard Deviation|Mean
754066|NCT00579813|Primary|Changes in Muscle Lipid After Pioglitazone|Muscle lipid following biopsy using oil red-O staining.|At baseline and 10 weeks|||arbitrary units of oil red O staining||Standard Deviation|Mean
754067|NCT00579813|Primary|Effects of Pioglitazone on Changes in BMI|Body Mass Index (BMI) is measured at baseline, in lean and obese subjects, and after pioglitazone in obese subjects|Baseline and 10 weeks|||kg/m2||Standard Deviation|Mean
754068|NCT00579813|Primary|Change in Insulin Sensitivity Using FSIGT|The frequently sampled intravenous glucose tolerance test (FSIGT) involves the injection of IV glucose and the frequent measurement of glucose and insulin.|Baseline and 10 weeks|||FSIGT units (x10^-4/min/uU/ml)||Standard Deviation|Mean
754069|NCT00579826|Secondary|Change in Biomarkers Associated With Bone and Cardiovascular Health, Adverse Events, Breast Cancer Prevention Trial (BCPT) Symptom Check List, Hot Flash Score, General Fatigue Inventory, the Fibromyalgia Impact Questionnaire.||6 Months, 12 Months||08/2017||||
754070|NCT00579826|Secondary|Change in Mammographic Density From Baseline to 6 Months..|Percent area of the breast considered to be at increased density, as determined by the computer program Cumulus..|Baseline to 6 Months|Subjects who complete the initial 6-months intervention and have mammograms available for analysis at baseline and 6 months, thus a change can be computed.||percentage of breast at high densit||Standard Deviation|Mean
754071|NCT00579826|Secondary|Assessment of Change in Morphology by the Masood Score.|Masood score is a semi-quantitative index of increasing abnormality, thus higher values are worse. Range 6 to 24.|Baseline to 6 Months|Subjects who complete initial 6-month intervention and have a repeat RPFNA, thus a change from baseline to 6-months can be computed.||units on a scale||Standard Deviation|Mean
754072|NCT00579826|Primary|Change in Proliferation Rate (Ki-67 by Immunocytochemistry) From Baseline to 6 Months|Change in proliferation rate (percent positively stained cells for Ki-67 antigen by immunocytochemistry) in benign breast epithelial cells acquired by random periareolar fine needle aspiration from women at high risk for the development of breast cancer.|Baseline to 6 Months|Subjects who complete initial 6-month period and have repeat RPFNA.||percentage of cells stained positive||Standard Deviation|Mean
754073|NCT00579982|Secondary|Number of Participants Indicating at Week 3 (by Answering Yes/no) That They Would be More Likely to Take the ODT Formulation|Tablet Routine Questionnaire (Adherence): Adherence to the treatment was evaluated by asking if the participant would be more likely to take the ODT formulation (yes/no)|End of Study (Week 3) or at Early Withdrawal|ITT: Only 94 of the 97 subjects in the ITT Population responded to the Tablet Routine Questionnaire.||Number of participants|||Number
754074|NCT00579982|Secondary|Number of Companions/Caregivers Indicating Whether ODT or Standard IR Tablet is More Convenient at Week 3|Companion/Caregiver indicates whether ODT is more convenient or standard IR tablet is more convenient|End of Study (Week 3) or at Early Withdrawal|ITT||Number of participants|||Number
754075|NCT00579982|Secondary|Number of Participants Indicating a Preference for ODT or the Standard IR Tablet at Week 3|Participant indicated whether preference was for ODT or the standard IR tablet|End of Study (Week 3) or at Early Withdrawal|ITT||Number of participants|||Number
754076|NCT00579982|Secondary|"Number of Participants Answering the Question Compared to Standard Tablets That Need to be Swallowed With Liquid, How Easy or Difficult is it to Use This Orally Disintegrating Tablet? at Week 3"|Organoleptic Questionnaire, question 9: Compared to standard tablets that need to be swallowed with liquid, how easy or difficult is it to use this orally disintegrating tablet? [from a rating of 1 (Extremely difficult) to 5 (Extremely easy)]|End of Study (Week 3) or at Early Withdrawal|ITT||Number of participants|||Number
754077|NCT00579982|Secondary|"Number of Participants Answering the Question Compared to Standard Tablets That Need to be Swallowed With Liquid, How Convenient or Inconvenient Did You Find This Orally Disintegrating Tablet? at Week 3"|Organoleptic Questionnaire, question 8: Compared to standard tablets that need to be swallowed with liquid, how convenient or inconvenient did you find this orally disintegrating tablet? (from a rating of 1 [Extremely inconvenient] to 5 [Extremely convenient])|End of Study (Week 3) or at Early Withdrawal|ITT||Number of participants|||Number
754408|NCT00581555|Secondary|PASI Area Under the Curve (AUC) Between Randomization and Week 24|PASI AUC = Area under the curve from randomization (Week 6) to Week 24.|Randomization to Week 24.|ITT population: included all randomized participants. n equals number of participants with evaluable data.||scores on a scale * weeks||Standard Error|Mean
754078|NCT00579982|Secondary|"Number of Participants Answering the Question How Satisfied Were You With the Aftertaste of the Tablet? at Week 3"|Organoleptic Questionnaire, question 7: How satisfied were you with the aftertaste of the tablet (the taste remaining in your mouth after swallowing the tablet)? [from a rating of 1 (Extremely dissatisfied) to 6 (I did NOT experience an aftertaste)]|Baseline, End of Study (Week 3) or Early Withdrawal|ITT||Number of participants|||Number
754079|NCT00579982|Secondary|"Number of Participants Answering the Question How Would You Rate the Aftertaste of the Tablet? at Week 3."|Organoleptic Questionnaire, question 6: How would you rate the aftertaste of the tablet (the taste remaining in your mouth after swallowing the tablet)? [from a rating of 1 (Extremely bothersome) to 6 (Did NOT experience an aftertaste)]|End of Study (Week 3) or Early Withdrawal|ITT||Number of participants|||Number
754080|NCT00579982|Secondary|"Number of Participants Answering the Question How Would You Rate the Strength of the Flavor of the Tablet? at Week 3"|Organoleptic Questionnaire, question 5: How would you rate the strength of the flavor of the tablet? [from 1 a rating of (Extremely bothersome) to 5 (Extremely pleasant)]|End of Study (Week 3) or Early Withdrawal|ITT||Number of participants|||Number
754081|NCT00579982|Secondary|"Number of Participants Answering the Question How Satisfied Were You With the Flavor of the Tablet? at Week 3"|Question number 4 on organoleptic questionnaire: How satisfied were you with the flavor of the tablet? [from a rating of 1 (Extremely dissatisfied) to 5 (Extremely satisfied)]|End of Study (Week 3) or Early Withdrawal|ITT||Number of participants|||Number
754082|NCT00579982|Secondary|Number of Participants Answering the Question “How Did the Dissolved Tablet Feel in Your Mouth?” at Week 3|Question number 3 on organoleptic questionnaire: How did the dissolved tablet feel in your mouth? [from a rating of 1 (Extremely gritty) to 5 (Extremely smooth)]|End of Study (Week 3) or Early Withdrawal|ITT||Number of participants|||Number
754083|NCT00579982|Secondary|"Number of Participants Answering the Question How Satisfied or Dissatisfied Were You With the Time it Took the Tablet to Dissolve at Week 3"|Question number 2 on organoleptic questionnaire: How satisfied or dissatisfied were you with the time it took the tablet to dissolve? [from a rating of 1 (Extremely dissatisfied) to 5 (Extremely satisfied)]|Baseline, End of Study (Week 3) or Early Withdrawal|ITT||Number of participants|||Number
754084|NCT00579982|Secondary|"Number of Participants Answering the Question Did the Tablets Dissolve Instantly (Yes or no)? at Week 3"|The Organoleptic Questionnaire (9 items) was used to assess the participants' satisfaction with the physical characteristics of the ODT formulation e.g. rate of dissolution, flavor. Question number 1 on organoleptic questionnaire: Did the tablets dissolve instantly (yes or no)?|End of Study (Week 3) or Early Withdrawal|ITT||Number of participants|||Number
754085|NCT00579982|Secondary|Mean Change From Baseline in the Beck Depression Inventory (BDI-II) Score at Week 3|Participant-reported questionnaire consisting of 21 items on a 4 point scale (0 to 3, with 3 indicating most severely ill), with the score being the sum of the items. The change from baseline is the end of study score minus the baseline score; larger values indicate more depression with the ODT formulation relative to the IR formulation.|Baseline, End of Study (Week 3 weeks) or at Early Withdrawal|ITT||Points on a scale||Standard Deviation|Mean
754086|NCT00579982|Secondary|Mean Change From Baseline in Clinical Global Impression of Illness-Severity at Week 3|Clinician assessment evaluating how mentally ill the patient is at time of evaluation. The questionnaire is based on a 7-point scale (from1 = Normal to 7 = Among the most extremely ill patients).|Baseline, End of Study (Week 3) or at Early Withdrawal|ITT||Points on a scale||Standard Deviation|Mean
754087|NCT00579982|Secondary|Mean Change From Baseline in the Global Satisfaction Subscale Score, From the TSQM Using Items 12 (Confidence in Medicine), 13 (Certainty That Good Things About Medication Outweigh Bad Things), and 14 (Satisfaction With Medication) at Week 3|The Global Satisfaction Subscale Score is the sum of item 12 (values: 1=Not at all confident - 5=Extremely confident), item 13 (values: 1=Not at all certain - 5=Extremely certain), and item 14 (Extremely dissatisfied - 7=Extremely satisfied). The sum has 3 subtracted from it, is divided by 14, and then multiplied by 100; thus, the range is 0-100.|Baseline, End of Study (Week 3) or Early Withdrawal|ITT||Points on a subscale||Standard Deviation|Mean
754088|NCT00579982|Primary|Mean Change From Baseline in the Convenience Subscale Score (CSS) Derived From the Treatment Satisfaction Questionnaire for Medication (TSQM v 1.4) Using Items 9 (Ease of Use), 10 (Ease of Planning to Use), and 11 (Convenience) at Week 3.|The CSS is the sum of items 9 (values: 1=Extremely difficult - 7=Extremely easy), 10 (same set of values as for 9), and 11 (1=Extremely inconvenient - 7=Extremely convenient). The sum has 3 subtracted from it, is divided by 18, and then multiplied by 100; the range is 0-100. Change from baseline=end of study CSS minus baseline score.|Baseline, End of Study (Week 3) or Early Withdrawal|Intent to Treat (ITT). Ninety-eight participants were enrolled in the study, but one withdrew prior to receiving lamotrigine ODT treatment. All efficacy and safety analyses are based on the Intent to Treat population, which includes the 97 patients who received at least one dose of ODT treatment.||Points on a subscale||Standard Deviation|Mean
754089|NCT00580034|Secondary|Response|Response Assessment included physical exam and evaluation of peripheral blood and bone marrow. There's no widely accepted criteria for response other than complete response (CR). CR for malignant hematologic diseases is met if all the following are met for >/= 1 month: a) absence of pathologic lymphadenopathy by physical and radiographic exam b) absence of constitutional symptoms due to disease c) Polymorphonuclear leukocyte count >1,500/uL; platelet count >50,000/uL; and hemoglobin >10.0 g/dL d) bone marrow aspirate/biopsy done after (a) through (c) have been met, >/= 30% cellularity and an absence of abnormal lymphoid nodules or cells by flow cytometry, cytogenetics, etc. e) molecular markers of disease must be negative by polymerase chain reaction, Fluorescence in situ hybridization, cytogenetics etc. CR for solid tumors requires complete resolution of disease on physical exam and radiographs. CR for marrow failure is normal white cell, platelet and hematocrit values.|2 years|Cohort of subjects on the study who actually received >/=1 donor lymphocyte infusion (DLI). DLI doses ranged from 1×104 CD3+ cells/kg to 3.27 ×108 CD3+ cells/kg. Subjects were considered for a second and third DLI 8 weeks apart if they did not have >grade 2 toxicity from the initial DLI, donor availability, and insurance approved the infusion.||months||Full Range|Mean
754090|NCT00580034|Primary|Overall Survival (OS)|Estimate toxicity and overall survival rates in subjects treated with a non-myeloablative preparative regimen followed by matched related allogeneic stem cells for allogeneic transplantation.|8 years|Subjects who completed CAMPATH regimen + 45 days, until disease progression, or death.||months||Full Range|Mean
778249|NCT00775190|Secondary|Side Effects (Nausea)|Number of days of nausea|6 months|Study Terminated with no data analysis|||||
754091|NCT00580034|Primary|Toxicity|Acute graft versus host disease (GVHD) was graded according to the consensus criteria and common terminology criteria (CTC) v3.0 was used for all other toxicities. Recognizing that acute GVHD pathology in the non-ablative and donor lymphocyte infusion (DLI) setting may occur late, we tabulated skin, gut and liver toxicity consistent with acute GVHD (aGVHD) at anytime in the year following the infusion as aGVHD. Toxicities were formally recorded for all patients twice weekly for the first 100 days, at each follow up visit, and as needed intercurrently.|1 year|Cohort of subjects on the study who received >/=1 donor lymphocyte infusion (DLI). DLI doses thus ranged from 1×104 CD3+ cells/kg to 3.27 ×108 CD3+ cells/kg. Subjects were considered evaluable from the day of first donor lymphocyte (DLI) infusion. Results are not exclusive.||participants|||Number
754092|NCT00580073|Secondary|Overall Survival|Overall survival is defined as the time from date of registration to date of death. In the absence of confirmation of death, survival time will be censored at the last date of follow-up.|Up to 3 years|This study was closed because of withdrawal of funding. All participants were off study on 02/03/2011.|||||
754093|NCT00580073|Secondary|Progression Free Survival|Number of participants who achieve progression free survival, defined as the time from date of registration to date of disease progression, up through study closure. Progressive disease is defined as ≥ 20% increase in the sum of the longest dimensions of the primary lesion taking as a reference the smallest sum of the longest dimensions recorded since the treatment started, or the appearance of 1 or more new lesions.|Up to 3 years|||participants|||Number
754094|NCT00580073|Primary|Down-staging of the Tumor; Response to Therapy|Down-staging of the tumor and tumor response rate is defined as the proportion of participant who have any evidence of complete response (CR), pathologic complete response (pCR), or partial response (PR).|6 months|||participants|||Number
754095|NCT00580138|Primary|Reliability Ratings Among Clinicians Using Real-time Internet Evaluation of Swallowing.|Percentages were calculated for agreement between ratings made by on site clinician and clinician off site with telemedicine.|2 years|||percent agreement|||Number
754096|NCT00580151|Secondary|Anxiety Reduction|"The Fear Thermometer measures how much fear subject is currently having. (0=None, 1= A little bit, 2= Some, 3= A lot, 4= Very, very much). The average of daily Value for 10 days."|Average of the 10 days|Patients analyzed were all patients consented.||units on a scale||Full Range|Mean
754097|NCT00580151|Primary|Pain Reduction|"The scale name is FACES (Faces Pain Rating Scale). Subjects were asked rate your WORST PAIN today (0 = no pain at all, 1-4 = mild pain, 5-6 = moderate pain, 7-9 = severe pain, 10 = excruciating pain). The Faces Pain Rating Scale should be collected every day and then averaged."|Average of the 10 days|Determined by the number of patients recruited.||units on a scale||Full Range|Mean
754098|NCT00580229|Secondary|DAS-28||weeks 4, 8, 16, 26||||||
754099|NCT00580229|Secondary|HAQ-DI||weeks 4, 8, 16, 26||||||
754100|NCT00580229|Secondary|All AE’s Through Week 26.||26 weeks||||||
754101|NCT00580229|Secondary|All AE’s Within 24 Hours Following the Second Infusion.||24 hours||||||
754102|NCT00580229|Secondary|All Acute Infusion Reactions With 24 Hours Following the Second Infusion.||24 hours||||||
754103|NCT00580229|Secondary|All Adverse Events (AE’s) Within 24 Hours Following the First Infusion.||24 hours||||||
754104|NCT00580229|Primary|The Safety and Tolerability of Rituximab in RA by Assessing Number of Participants With Acute Infusion Reactions in the First 24 Hours.|The safety and tolerability of rituximab in RA by assessing number of participants with acute infusion reactions in the first 24 hours.|24 hours|The subjects full filled the American College of Rheumatology Criteria for Rheumatoid Arthritis.||participants|||Number
754105|NCT00580294|Primary|Brief Pain Inventory||Assessed daily for 10 days prior to IV PCA treatment, and assessed daily for 2 weeks after IV PCA treatment||||||
754106|NCT00580294|Primary|Change in Patient Global Impression of Change|PGIC score - participants answered 2 questions regarding change in overall status and overall activity from baseline using a 7-point scale (1 = Very Much Improved, 2 = Much Improved, 3 = Minimally Improved, 4 = No Change, 5 = Minimally Worse, 6 = Much Worse, 7 = Very Much Worse)|baseline and 12 hours|||units on a scale||95% Confidence Interval|Mean
754107|NCT00580333|Secondary|Patients With Miller-Payne (MP) Score 3, 4, or 5 Response|To describe a panel of molecular assays for an association with clinical response and, if feasible, with pathologic complete response (pCR) in ER-, PR-, HER2-negative subjects treated with cisplatin and bevacizumab in the preoperative setting. A Miller-Payne (MP) score of 3 indicates a decrease in the size of the cancer by 30% to 90%. A MP score of 4 indicates marked decrease in the size of the cancer by greater than 90%. A MP score of 5 indicates there is no residual cancer remaining (the same as a pathologic complete response).|2 years|||percentage of participants||95% Confidence Interval|Number
754108|NCT00580333|Secondary|Toxicity of Administering Bevacizumab in Combination With Standard Adjuvant Chemotherapy.|Number of patients who were unable to receive all cycles of chemotherapy on time for toxicity reasons.|2 years|analyzed the 43 patients who completed 4 cycles of neoadjuvant therapy and started post-operative treatment||Participants|||Count of Participants
754109|NCT00580333|Secondary|Clinical Overall and Complete Response Rates After Preoperative Therapy With Cisplatin and Bevacizumab|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|2 years|||Participants|||Count of Participants
754110|NCT00580333|Primary|Pathologic Complete Response Rate After Preoperative Therapy With Cisplatin and Bevacizumab in ER-, PR-, Human Epidermal Growth Factor Receptor 2 (HER2) -Negative Early Breast Cancer.|The goal of this measure was to determine the pathologic complete response rate (Miller-Payne (MP) score 5) after preoperative therapy with cisplatin and bevacizumab in ER-, PR-, HER2-negative early breast cancer.|2 years|||percentage of participants||95% Confidence Interval|Number
754111|NCT00580372|Primary|Percentage of Participants That Are Relapse-free 5 Years After Initial Therapy|"Relapse is defined by the unequivocal objective evidence of recurrent disease such as:
myeloma-related cytogenetic abnormalities; bone marrow plasmacytosis >10% or >5% light chain restricted, non-diploid, plasma cells on clg/DNA; new skeletal or MRI lesions; hypercalcemia not explained by any other cause; or reappearance of M-protein in blood or urine not related to immune recovery, recent infection, and present for >2 months."|5 years|||percentage of participants|||Number
778250|NCT00775190|Primary|Days of Bleeding|Number of days with bleeding during each menstrual period.|6 months|Study Terminated with no data analysis|||||
754112|NCT00580398|Secondary|Biochemically-validated 7-day Point Prevalence Tobacco Abstinence|7-day point prevalence abstinence (“Have you smoked a cigarette, even a puff, in the past 7 days?”) was assessed at 12-week follow-up. Self reported abstinence was confirmed only if a salivary cotinine level was < 15 ng/ml or an expired carbon monoxide measurement was <10 ppm.|12 weeks|46 participants (32 intervention, 14 control) returned a cotinine confirmation kit for biochemical validation of 7 day point prevalent tobacco abstinence at 12 weeks. 3 control participants were excluded from the follow-up analysis.||participants|||Number
754113|NCT00580398|Primary|Determination of the Feasibility of a Cognitive Behavioral Smoking Cessation Intervention.|Number of participants who completed the 12-week follow-up survey and thus the study.|12 weeks|||participants|||Number
754114|NCT00580502|Secondary|Level of HbA1c (Blood Test for Diabetes) After Laparoscopic Adjustable Gastric Band Surgery|Change in level of HbA1c from baseline at 5 years|5 years|All participants who underwent LAGB and had 5 year f/u visit are included in the analysis population.||percentage of HbA1c||Standard Deviation|Mean
754115|NCT00580502|Secondary|Level of Triglycerides (Bad Cholesterol) After Laparoscopic Adjustable Gastric Band Surgery|Change in level of Triglycerides from baseline at 5 years|5 years|All participants who underwent LAGB and had 5 year follow up visit are included in the analysis population.||mg/dl||Standard Deviation|Mean
754116|NCT00580502|Secondary|Level of LDL (Bad Cholesterol) After Laparoscopic Adjustable Gastric Band Surgery|Change in level of LDL from baseline at 5 years|5 years|All participants who underwent LAGB are included in the analysis population.||mg/dl||Standard Deviation|Mean
754117|NCT00580502|Primary|To Determine Percent of Excess Weight Loss (%EWL) After Laparoscopic Adjustable Gastric Banding Surgery|Change in weight from baseline at 5 years by calculating the percentage of the weight loss from the total excess weight.|5 years|All participants who underwent LAGB are included in the analysis population.||percentage of excess weight loss||Standard Deviation|Mean
754125|NCT00580671|Primary|Marijuana Abstinence (4 Weeks or Greater)|Percentage of participants who achieved 4 continuous weeks of marijuana abstinence as verified by twice weekly urine testing during the 14 weeks of treatment.|Twice weekly urine tests for 14 weeks.|||percentage of participants|||Number
755522|NCT00594425|Secondary|Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain.|Measure was assessed on a Visual Analogue Scale from 0 to 10 cm|immediately after illumination-first treatment|Safety||cm||Full Range|Median
754126|NCT00580671|Secondary|Proportion of Days of Marijuana Abstinence Across All Days of Treatment (14 Weeks)|This reflects the mean proportion of days of marijuana abstinence for each participant|This is for the proportion of days abstinent across the entire 14-week treatment period. Self-report data are collected twice weekly during treatment to obtain a cumulative proportion|Those participants with data on at least 80 days of the 91 days of treatment were used in this analysis.||proportion of marijuana abstinent days||Standard Deviation|Mean
754127|NCT00580671|Primary|Marijuana Abstinence (2 Weeks or Greater)|Percentage of participants who achieved 2 continuous weeks of marijuana abstinence as verified by twice weekly urine testing during the 14 weeks of treatment.|Testing done twice weekly for 14 weeks.|||percentage of participants|||Number
754128|NCT00580723|Primary|Telangiectasia Severity|Measured by percent improvement on a scale of 0-4. Subjects received a 0 for no improvement, 1 for less than twenty-five percent improvement, a 2 for twenty-five to fifty percent improvement, a 3 for fifty to seventy-five percent improvement and a 4 for greater than seventy-five percent improvement. Mean scores from all continuing 16 participants were averaged for each encounter, for a total of 8 visits. The percent improvement in mean telangiectasia severity was calculated by comparing the change in mean scores at week 48 to mean scores assessed at baseline.|Baseline, Weeks 1, 4, 8, 12, 24, 36, 48|We had a total of 24 subjects. Five were lost to follow up and three did not want to participate in the extension period. The results from the remaining 16 subjects were analyzed.||Telangiectasia percent improvement||Standard Deviation|Mean
754129|NCT00580723|Primary|Inflammatory Lesion Count|Lesion counts were numerically summed for each patient at each encounter, and the average lesion count was calculated from all continuing 16 subjects at each visit, for a total of 8 visits. Percent improvement (reduction in lesion number) was assessed by comparing the average number of lesions at week 48 to the average number of lesions assessed at baseline.|Baseline, Weeks 1, 4, 8, 12, 24, 36, 48|We had a total of 24 subjects. Five were lost to follow up and three did not want to participate in the extension period. The results from the remaining 16 subjects were analyzed.||Percent change in number of lesions||Standard Deviation|Mean
754130|NCT00580723|Secondary|Cosmetic Acceptability||Baseline, Weeks 1, 4, 8, 12, 24, 36, 48||||||
754131|NCT00580723|Secondary|Transepidermal Water Loss (TEWL)||Baseline, Weeks 1, 4, 8, 12, 24, 36, 48||||||
754132|NCT00580723|Secondary|Skin Photodamage||Baseline, Weeks 1, 4, 8, 12, 24, 36, 48||||||
754133|NCT00580723|Secondary|Skin Tolerance||Baseline, Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48||||||
754134|NCT00580723|Primary|Erythema Severity|Measured by percent improvement on a scale of 0-4. Subjects received a 0 for no improvement, 1 for less than twenty-five percent improvement, a 2 for twenty-five to fifty percent improvement, a 3 for fifty to seventy-five percent improvement and a 4 for greater than seventy-five percent improvement. Mean scores from all continuing 16 participants were averaged for each encounter, for a total of 8 visits. The percent improvement in mean erythema severity was calculated by comparing the change in mean scores at week 48 to mean scores assessed at baseline.|Baseline, Weeks 1, 4, 8, 12, 24, 36, 48|We had a total of 24 subjects. Five were lost to follow up and three did not want to participate in the extension period. The results from the remaining 16 subjects were analyzed.||Erythema percent improvement||Standard Deviation|Mean
754135|NCT00580788|Secondary|Fractional Excretion of Calcium|% calculated from daily second morning void|daily|||% of filtered load||Standard Error|Mean
754136|NCT00580788|Secondary|Parathyroid Hormone (1-84)|pg/ml|Baseline and Daily|||pg/ml||Standard Error|Mean
754137|NCT00580788|Secondary|Bone Specific Alkaline Phosphatase (BSAP)|% change from baseline|Baseline, Daily, and 1 week follow-up|||% change||Standard Error|Mean
754138|NCT00580788|Secondary|Amino-terminal Peptides of Procollagen 1 (P1NP)|% change from baseline|Baseline, Daily, and 1 week follow-up|||% change||Standard Error|Mean
754139|NCT00580788|Secondary|Serum Carboxy-terminal Telopeptide of Collagen -1 (sCTX)|% change from baseline|Baseline, Daily, and 1 week follow-up|||% change||Standard Error|Mean
754140|NCT00580788|Secondary|Serum Amino-terminal Telopeptide of Collagen -1 (sNTX)|% change from baseline|Baseline, Daily, and 1 week follow-up|||% change||Standard Error|Mean
754141|NCT00580788|Primary|Serum Phosphorous|mg/dl|12 hours after the infusion was started then q 8 hours for 7 days, Follow-up 1 week after infusion complete|||mg/dl||Standard Error|Mean
754142|NCT00580788|Primary|Ionized Serum Calcium|mg/dl|12 hours after the infusion was started then q 8 hours for 7 days, Follow-up 1 week after infusion complete|||mg/dl||Standard Error|Mean
754143|NCT00580788|Primary|Total Serum Calcium|mg/dl|12 hours after the infusion was started then q 8 hours for 7 days, Follow-up 1 week after infusion complete|||mg/dl||Standard Error|Mean
754144|NCT00580788|Secondary|Tubular Maximum of Phosphorous (TmP/GFR)|mg/dl calculated from daily second morning void|daily|||mg/dl||Standard Error|Mean
754145|NCT00580788|Secondary|24 Hour Urine Calcium|mg/gm creatinine collected on day 7 of PTHrP infusion|24 hours|||mg/gm creatinine||Standard Error|Mean
754146|NCT00580788|Secondary|1,25 Vitamin D|pg/ml|Baseline and Daily through day 8 then at follow-up visit|||pg/ml||Standard Error|Mean
754147|NCT00580788|Primary|Dose Limiting Toxicity (DLT)|DLT was defined as achieving one major criterion or two minor criteria rated at ≥ 2 on a scale of 0-5. The major criteria were defined as symptomatic orthostatic hypotension (systolic BP fall >30 mm/hg), tachycardia (pulse > 120), hypertension (systolic BP >160 mm/hg on 2 occasions), hypercalcemia (serum calcium ≥ 12 mg/dl), and hypophosphatemia (serum phosphorous < 1.5 mg/dl). Minor criteria included symptoms such as flushing, nausea, abdominal or muscle cramps, dizziness, lightheadedness, palpitations, etc.|12 hours after the infusion was started then q 8 hours for 7 days|||participants|||Number
754148|NCT00580801|Secondary|Average Steady-State Serum Concentration (Css,av) of Telaprevir|The Average steady-state serum concentration (Css,av) was calculated by AUC/τ at steady-state (τ=dosing interval) of telaprevir and then pegylated–interferon-alfa-2a+Ribavirin (reference) and telaprevir+pegylated–interferon-alfa-2a+Ribavirin (test).|Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 1 and 15|"ITT population included any randomized participant who received at least 1 dose of telaprevir/placebo. N signifies those participants who were evaluated for this measure."||Nanogram/milliliter (ng/mL)||Standard Deviation|Mean
754419|NCT00582738|Secondary|Percentage of Patients With Death, Graft Loss and Biopsy Proven Acute Rejection (BPAR) Between Study Groups||24 Months|The Intent to Treat (ITT) population consisted of all patients randomized and who had at least one dose of study medication.||Percentage of Participants|||Number
754149|NCT00580801|Secondary|Time to Reach the Maximum Serum Concentration (Tmax) of Telaprevir|The tmax is the time to reach maximum observed serum concentration of telaprevir and then pegylated–interferon-alfa-2a+Ribavirin (reference) and pegylated–interferon-alfa-2a+Ribavirin (test).|Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 1 and 15|"ITT population included any randomized participant who received at least 1 dose of telaprevir/placebo. n signifies number of participants with data for this measure at the specified time point for each arm group respectively."||Hours||Full Range|Median
754150|NCT00580801|Secondary|Minimum Serum Concentration (Cmin) of Telaprevir on Day 15|The Cmin is the minimum serum concentration between 0 hour and τ (τ=dosing interval) of telaprevir and then pegylated–interferon-alfa-2a+Ribavirin (reference) and telaprevir+pegylated–interferon-alfa-2a+Ribavirin (test). Cmin on Day 15 is reported here.|Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 15|"ITT population included any randomized participant who received at least 1 dose of telaprevir/placebo. N signifies those participants who were evaluated for this measure."||Nanogram/milliliter (ng/mL)||Standard Deviation|Mean
754151|NCT00580801|Secondary|Pre-Dose Serum Concentration (C[0h]) of Telaprevir|The C(0h) is the pre-dose serum concentration of telaprevir and then pegylated–interferon-alfa-2a+Ribavirin (reference) and telaprevir+pegylated–interferon-alfa-2a+Ribavirin (test).|0 hour (pre-dose) at Day 15|"ITT population included any randomized participant who received at least 1 dose of telaprevir/placebo. N signifies those participants who were evaluated for this measure."||Nanogram/milliliter (ng/mL)||Standard Deviation|Mean
754152|NCT00580801|Secondary|Maximum Serum Concentration (Cmax) of Telaprevir|The Cmax is the maximum observed serum concentration, which was measured at Day 1 and 15 for telaprevir and then pegylated–interferon-alfa-2a+Ribavirin (reference) and telaprevir+pegylated–interferon-alfa-2a+Ribavirin (test).|Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 1 and 15|"ITT population included any randomized participant who received at least 1 dose of telaprevir/placebo. n signifies number of participants with data for this measure at the specified time point for each arm group respectively."||Nanogram/milliliter (ng/mL)||Standard Deviation|Mean
754153|NCT00580801|Secondary|Area Under the Serum Concentration-Time Curve (AUC)|The AUC is a measure of the serum concentration-time curve, calculated by the lin-up/log-down method.|Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 1 and 15|"Intent-to-treat (ITT) population included any randomized participant who received at least 1 dose of telaprevir/placebo. n signifies number of participants with data for this measure at the specified time point for each arm group respectively."||nanogram*hour/milliliter (ng*h/mL)||Standard Deviation|Mean
754154|NCT00580801|Secondary|Percentage of Participants With Relapse|Relapse was defined as having confirmed detectable HCV RNA during the 24-week follow-up period in participants who had undetectable HCV RNA at EOT (Week 48/50 or early discontinuation). Participants who dropped out between 24-week follow-up after EOT were not evaluated for relapse.|Week 24 after EOT (Week 48/50 or early discontinuation)|"Full analysis included all randomized participants who received at least one dose of the telaprevir or placebo. N signifies those participants who were evaluated for this measure."||Percentage of participants|||Number
754155|NCT00580801|Secondary|Percentage of Participants With Sustained Viral Response (SVR)|Sustained viral response was defined as having undetectable HCV RNA at EOT (Week 48/50 or early discontinuation) and no confirmed detectable HCV RNA levels between EOT and 12 weeks (SVR12) and 24 weeks (SVR24) after the last dose of study medication.|Week 12 and 24 after the last dose of study medication|Full analysis included all randomized participants who received at least one dose of the telaprevir or placebo.||Percentage of participants|||Number
754156|NCT00580801|Secondary|Number of Participants With Viral Breakthrough (Detectable HCV RNA)|Viral breakthrough was defined as having a confirmed increase greater than 1 log 10 in HCV RNA level from the lowest level reached, or a confirmed level of HCV RNA greater than 100 IU/mL in participants whose HCV RNA had previously become undetectable [less than 25 IU/mL]). In Week x/y, where, x represents time frame for Telaprevir+pegylated-interferon-alfa-2a+Ribavirin and Placebo+pegylated-interferon-alfa-2a+Ribavirin and y represents time frame for Telaprevir and then Pegylated-interferon-alfa-2a+Ribavirin treatment group.|Day 8, Day 12, Day 15, Week 24/26 and Week 36/38|Full analysis included all randomized participants who received at least one dose of the telaprevir or placebo.||Participants|||Number
754157|NCT00580801|Secondary|Median Time to First Viral Response (Undetectable HCV RNA)|Time to first viral response (Undetectable HCV RNA) is defined as the number of days since the start of study medication until first time negative HCV RNA level that is less than 25 IU/mL was detected.|Up to Week 48/50|Full analysis included all randomized participants who received at least one dose of the telaprevir or placebo.||Days||95% Confidence Interval|Median
754158|NCT00580801|Secondary|Percentage of Participants With Viral Response (Undetectable HCV RNA)|Viral response was either defined as having undetectable HCV RNA (that is, no HCV RNA was detected in the participants’ plasma samples) or less than 25 IU/mL HCV RNA from Day 15 up to end of treatment (EOT), that is Week 48/50 or early discontinuation. In Week x/y, where, x represents time frame for Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin and Placebo+Pegylated-interferon-alfa-2a+Ribavirin and; y represents time frame for Telaprevir and Pegylated-interferon-alfa-2a+Ribavirin treatment group.|Day 15 up to EOT (Week 48/50 or early discontinuation)|"Full analysis included all randomized participants who received at least one dose of the telaprevir or placebo. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."||Percentage of participants|||Number
754159|NCT00580801|Primary|Change From Baseline in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Day 15|The plasma HCV RNA levels were used to assess the antiviral activity which included viral response as either undetectable HCV RNA (that is no HCV target was detected in the plasma sample) or less than 25 International unit per milliliter (IU/mL) of HCV RNA (that is Plasma sample contained HCV RNA at a concentration below the limit of quantification [LLOQ=25 IU/mL] of the viral load assay). Plasma HCV RNA levels were measured using the COBAS TaqMan HCV test Version 2.0. This assay used real-time reverse transcription-polymerase chain reaction (RT-PCR) methodology.|Baseline and Day 15|"Full analysis included all randomized participants who received at least one dose of the telaprevir or placebo. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."||log 10 IU/mL||Full Range|Median
754448|NCT00582907|Secondary|To Determine the Difference in the Length of Attacks During Treatment With Rilonacept vs. Placebo.|This outcome was the difference in days in the length of attacks between rilonacept and placebo.|12 months|Participants who received any treatment and had recorded attacks||Number of days||95% Confidence Interval|Median
754160|NCT00580840|Other Pre-specified|Change From Baseline in SJC (Swollen Joint Count) at Week 34 in Patients Randomized at Week 18|Change from Baseline in Swollen Joint Count is computed as the value at Week 34 minus the Baseline value (28 joints were assessed at each visit). A negative value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 207 subjects (69 400 mg CZP, 70 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.||Joints||Standard Error|Least Squares Mean
754161|NCT00580840|Other Pre-specified|Change From Baseline in TJC (Tender Joint Count) at Week 34 in Patients Randomized at Week 18|Change from Baseline in Tender Joint Count is computed as the value at Week 34 minus the Baseline value (28 joints were assessed at each visit). A negative value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 207 subjects (69 400 mg CZP, 70 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.||Joints||Standard Error|Least Squares Mean
754162|NCT00580840|Other Pre-specified|Change From Baseline in PhGADA (Physician’s Global Assessment of Disease Activity) at Week 34 in Patients Randomized at Week 18|Change from Baseline in Physician’s Global Assessment of Disease Activity-VAS (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as the value at Week 34 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 206 subjects (69 400 mg CZP, 70 200 mg CZP, 67 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.||units on a scale||Standard Error|Least Squares Mean
754163|NCT00580840|Other Pre-specified|Ratio From Baseline in ESR (Erythrocyte Sedimentation Rate) Level at Week 34 in Patients Randomized at Week 18|Ratio is defined as the ESR value at Week 34 divided by the ESR value at Baseline. This analysis was carried out using the Last Observation Carried Forward (LOCF) method with an ANCOVA model on observed log transformed data with factors treatment and log transformed Baseline CRP level. The number presented is the geometric least squares mean with it's 95% confidence interval.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 205 subjects (69 400 mg CZP, 68 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.||Ratio||95% Confidence Interval|Least Squares Mean
754164|NCT00580840|Other Pre-specified|Ratio From Baseline in ESR (Erythrocyte Sedimentation Rate) Level at Week 16 in All Patients|Ratio is defined as the ESR value at Week 16 divided by the ESR value at Baseline. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 16|Of the 333 subjects in the Run-in period, 328 are included in this analysis using the Last Observation Carried Forward (LOCF) method.||Ratio||Geometric Coefficient of Variation|Geometric Mean
754165|NCT00580840|Secondary|Median Time to Loss of ACR20 (American College of Rheumatology 20% Improvement) Response After Week 18 in Patients Randomized at Week 18.|ACR20 loss are subjects with <20% improvement from Baseline for tender joint count, swollen joint count, and at least 3/5 core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein, 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale at 2 consecutive visits. Subjects losing response for 2 consecutive visits are considered as having the event on the day of the visit where response was first lost.|Week 18 up to Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 208 subjects (69 400 mg CZP, 70 200 mg CZP, 69 placebo) are included in this analysis.||days||Inter-Quartile Range|Median
754166|NCT00580840|Secondary|Change From Baseline in PtGADA (Patient's Global Assessment of Disease Activity) at Week 34 in Patients Randomized at Week 18|Change from Baseline in Patient’s Global Assessment of Disease Activity-VAS (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as the value at Week 34 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 207 subjects (69 400 mg CZP, 70 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.||units on a scale||Standard Error|Least Squares Mean
754167|NCT00580840|Secondary|Change From Baseline in PAAP (Patient's Assessment of Arthritis Pain) at Week 34 in Patients Randomized at Week 18|Change from Baseline in Patient’s Assessment of Arthritis Pain-VAS (0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain) is computed as the value at Week 34 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 207 subjects (69 400 mg CZP, 70 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.||units on a scale||Standard Error|Least Squares Mean
754168|NCT00580840|Secondary|Change From Baseline in MCS (Short Form 36-item Health Survey Mental Component Summary) at Week 34 in Patients Randomized at Week 18|MCS norm-based scores are calculated based upon the following 8 domain scores, Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, and range from -9 to 82, where 50 represents the normative value. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 202 subjects (66 400 mg CZP, 68 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.||units on a scale||Standard Error|Least Squares Mean
754230|NCT00581230|Primary|Glottic View as Assessed by the Cormack and Lehane Classification|Glottic view as described by Cormack and Lehane (Samsoon GL, Young JR. Difficult tracheal intubation: A retrospective study. Anesthesia 1987; 42:487), scored as follows- Grade 1. Full view of glottis Grade 2a. Partial view of glottis Grade 2b. Arytenoids or posterior portion of cords just visible Grade 3. Only the epiglottis visible Grade 4. Neither epiglottis nor glottis visible|before intubation|||participants|||Number
754169|NCT00580840|Secondary|Change From Baseline in PCS (Short Form 36-item Health Survey Physical Component Summary) at Week 34 in Patients Randomized at Week 18|PCS norm-based scores are calculated based upon the following 8 domain scores, Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, and range from 1 to 81, where 50 represents the normative value. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 202 subjects (66 400 mg CZP, 68 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.||units on a scale||Standard Error|Least Squares Mean
754170|NCT00580840|Secondary|Change From Baseline in Mental Health (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 205 subjects (68 400 mg CZP, 69 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.||units on a scale||Standard Error|Least Squares Mean
754171|NCT00580840|Secondary|Change From Baseline in Role Emotional (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 204 subjects (67 400 mg CZP, 69 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.||units on a scale||Standard Error|Least Squares Mean
754172|NCT00580840|Secondary|Change From Baseline in Social Functioning (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 207 subjects (69 400 mg CZP, 70 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.||units on a scale||Standard Error|Least Squares Mean
754173|NCT00580840|Secondary|Change From Baseline in Vitality (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 205 subjects (68 400 mg CZP, 69 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.||units on a scale||Standard Error|Least Squares Mean
754174|NCT00580840|Secondary|Change From Baseline in General Health (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 205 subjects (68 400 mg CZP, 69 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.||units on a scale||Standard Error|Least Squares Mean
754175|NCT00580840|Secondary|Change From Baseline in Bodily Pain (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 206 subjects (69 400 mg CZP, 69 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.||units on a scale||Standard Error|Least Squares Mean
754176|NCT00580840|Secondary|Change From Baseline in Role Physical (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 206 subjects (69 400 mg CZP, 69 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.||units on a scale||Standard Error|Least Squares Mean
754231|NCT00581230|Primary|Ease of Mask Ventilation as Assessed by Han Class|Grading Scale for Mask Ventilation as described by Han et al. (Anesthesiology. 2004 Jul;101(1):267) Grade 0. Ventilation by mask not attempted Grade 1. Ventilated by mask Grade 2. Ventilated by mask with oral airway/adjuvant with or without muscle relaxant Grade 3. Difficult ventilation (inadequate, unstable, or requiring two providers) with or without muscle relaxant Grade 4. Unable to mask ventilate with or without muscle relaxant|Time before intubation|||participants|||Number
778251|NCT00775190|Primary|Incidence of Breakthrough Bleeding|Any breakthrough bleeding during reporting period.|6 months|Study Terminated with no data analysis|||||
754177|NCT00580840|Secondary|Change From Baseline in Physical Functioning (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 207 subjects (69 400 mg CZP, 70 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.||units on a scale||Standard Error|Least Squares Mean
754178|NCT00580840|Secondary|Change From Baseline in Fatigue Assessment Scale (FAS) at Week 34 in Patients Randomized at Week 18|Change from Baseline in Fatigue Assessment scale (0 to 10, 0 is “No Fatigue” and 10 is “Fatigue as bad as you can imagine”) is computed as the value at Week 34 minus the Baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 205 subjects (68 400 mg CZP, 70 200 mg CZP, 67 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.||units on a scale||Standard Error|Least Squares Mean
754179|NCT00580840|Secondary|Change From Baseline in HAQ-DI (Health Assessment Questionnaire-Disability Index) Score at Week 34 in Patients Randomized at Week 18|HAQ-DI is derived based on the mean of individual scores in 8 categories of daily living actives (using 20 questions). Each question is scored 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do). Thus, the mean also has a range from 0-3. Change from baseline is computed as the value at Week 34 minus the baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 207 subjects (69 400 mg CZP, 70 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.||units on a scale||Standard Error|Least Squares Mean
754180|NCT00580840|Secondary|Ratio From Baseline in CRP (C-reactive Protein) Level at Week 34 in Patients Randomized at Week 18|Ratio is defined as the CRP value at Week 34 divided by the CRP value at Baseline. This analysis was carried out using the Last Observation Carried Forward (LOCF) method with an ANCOVA model on observed log transformed data with factors treatment and log transformed Baseline CRP level. The number presented is the geometric least squares mean with it's 95% confidence interval.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 207 subjects (69 400 mg CZP, 70 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.||Ratio||95% Confidence Interval|Least Squares Mean
754181|NCT00580840|Secondary|CDAI (Clinical Disease Activity Index) Remission (CDAI ≤2.8) at Week 34 in Patients Randomized at Week 18|"CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm), and Investigator’s Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI).
The range for the CDAI is 0 - 76 with a lower CDAI score indicating approvement in activity and a higher score indicating a decline activity."|Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 208 subjects (69 400 mg CZP, 70 200 mg CZP, 69 placebo) are included in this analysis which uses Non-Response Imputation (NRI).||percentage of subjects|||Number
754182|NCT00580840|Secondary|SDAI (Simplified Disease Activity Index) Remission (SDAI ≤3.3) at Week 34 in Patients Randomized at Week 18|"SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm), and Investigator’s Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI).
<= 3.3 (Remission), > 3.3 - <= 11 Low, > 11 - <= 26 Moderate, > 26 High"|Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 208 subjects (69 400 mg CZP, 70 200 mg CZP, 69 placebo) are included in this analysis which uses Non-Response Imputation (NRI).||percentage of subjects|||Number
754183|NCT00580840|Secondary|DAS28 (Disease Activity Score-28 Items) Remission (DAS28 <2.6) at Week 34 in Patients Randomized at Week 18|"DAS28-ESR is calculated using the tender joint count (TJC), swollen joint count (SJC) erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI).
< 2.6 (Remission),
> = 2.6 - < =3.2 Low, > 3.2 - < = 5.1 Moderate, > 5.1 High"|Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 208 subjects (69 400 mg CZP, 70 200 mg CZP, 69 placebo) are included in this analysis which uses Non-Response Imputation (NRI).||percentage of subjects|||Number
754184|NCT00580840|Secondary|Change From Baseline in CDAI (Clinical Disease Activity Index) at Week 34 in Patients Randomized at Week 18|CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm), and Investigator’s Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score. Range for CDAI is 0-76 with a lower CDAI score reflects approvement in activity and a higher score reflects a decline.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 206 subjects (69 400 mg CZP, 70 200 mg CZP, 67 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.||units on a scale||Standard Error|Least Squares Mean
754338|NCT00574990|Secondary|Overall Involvement in Conversation by Roles|The number of communication events was recorded on electronic notepads during each observation period. The communication events recorded included: a) physicians to physicians, to nurses, to pharmacists, and to patients; b) nurses to nurses, to physicians, to pharmacists, and to patients; and c) pharmacists to pharmacists, to physicians, to nurses, and to patients. The percentage of each of these types of verbal communications was calculated from the total number of communication events.|6 months|||percentage of role involvement in event|||Number
754185|NCT00580840|Secondary|Change From Baseline in SDAI (Simplified Disease Activity Index) at Week 34 in Patients Randomized at Week 18|"SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm), and Investigator’s Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.
<= 3.3 Remission, > 3.3 - <= 11 Low, > 11 - <= 26 Moderate, > 26 High"|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 205 subjects (68 400 mg CZP, 70 200 mg CZP, 67 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.||units on a scale||Standard Error|Least Squares Mean
754186|NCT00580840|Secondary|Change From Baseline in DAS28 (Disease Activity Score-28 Items) at Week 34 in Patients Randomized at Week 18|"DAS28-ESR is calculated using the tender joint count (TJC), swollen joint count (SJC) erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward.
< 2.6 Remission,
> = 2.6 - < =3.2 Low, > 3.2 - < = 5.1 Moderate, > 5.1 High"|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 204 subjects (69 400 mg CZP, 68 200 mg CZP, 67 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.||units on a scale||Standard Error|Least Squares Mean
754187|NCT00580840|Secondary|Percentage of ACR70 (American College of Rheumatology 70% Improvement) Responders at Week 34 in Patients Randomized at Week 18|ACR70 responders are subjects with at least 70% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. Missing values were imputed using Non-Responder Imputation (NRI)|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 208 subjects (69 400 mg CZP, 70 200 mg CZP, 69 placebo) are included in this analysis which uses Non-Response Imputation (NRI).||percentage of subjects|||Number
754188|NCT00580840|Secondary|Percentage of ACR50 (American College of Rheumatology 50% Improvement) Responders at Week 34 in Patients Randomized at Week 18|ACR50 responders are subjects with at least 50% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. Missing values were imputed using Non-Responder Imputation (NRI)|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 208 subjects (69 400 mg CZP, 70 200 mg CZP, 69 placebo) are included in this analysis which uses Non-Response Imputation (NRI).||percentage of subjects|||Number
754189|NCT00580840|Secondary|Change From Baseline in HAQ-DI (Health Assessment Questionnaire-Disability Index) Score at Week 16 in All Patients|HAQ-DI is derived based on the mean of individual scores in 8 categories of daily living actives (using 20 questions). Each question is scored 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do). Thus, the mean also has a range from 0-3. Change from baseline is computed as the value at Week 16 minus the baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 16|Of the 333 subjects in the Run-in period, 330 are included in this analysis using the Last Observation Carried Forward (LOCF) method.||units on a scale||Standard Deviation|Mean
754190|NCT00580840|Secondary|Ratio From Baseline in CRP (C-reactive Protein) Level at Week 16 in All Patients|Ratio is defined as the CRP value at Week 16 divided by the CRP value at Baseline. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 16|Of the 333 subjects in the Run-in period, 330 are included in this analysis using the Last Observation Carried Forward (LOCF) method.||Ratio||Geometric Coefficient of Variation|Geometric Mean
754191|NCT00580840|Secondary|CDAI (Clinical Disease Activity Index) Remission (CDAI ≤2.8) at Week 16 in All Patients|"CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm), and Investigator’s Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI).
The range for the CDAI is 0 - 76 with a lower CDAI score indicating approvement in activity and a higher score indicating a decline activity."|Week 16|Since Non-Response Imputation (NRI) was used, all 333 subjects in the run-in period are included in this analysis||percentage of subjects|||Number
754192|NCT00580840|Secondary|SDAI (Simplified Disease Activity Index) Remission (SDAI ≤3.3) at Week 16 in All Patients|"SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm), and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI).
<= 3.3 (Remission), > 3.3 - <= 11 Low, > 11 - <= 26 Moderate, > 26 High"|Week 16|Since Non-Response Imputation (NRI) was used, all 333 subjects in the run-in period are included in this analysis||percentage of subjects|||Number
754193|NCT00580840|Secondary|DAS28 (Disease Activity Score-28 Items) Remission (DAS28 <2.6) at Week 16 in All Patients|"DAS28-ESR is calculated using the tender joint count (TJC), swollen joint count (SJC) erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI).
< 2.6 (Remission),
> = 2.6 - < =3.2 Low, > 3.2 - < = 5.1 Moderate, > 5.1 High"|Week 16|Since Non-Response Imputation (NRI) was used, all 333 subjects in the run-in period are included in this analysis||percentage of subjects|||Number
754194|NCT00580840|Secondary|Change From Baseline in CDAI (Clinical Disease Activity Index) at Week 16 in All Patients|"CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm), and Investigator’s Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
The range for the CDAI is 0 - 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity."|Baseline, Week 16|Of the 333 subjects in the Run-in period, 328 are included in this analysis using the Last Observation Carried Forward (LOCF) method.||units on a scale||Standard Deviation|Mean
754195|NCT00580840|Secondary|Change From Baseline in SDAI (Simplified Disease Activity Index) at Week 16 in All Patients|"SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm), and Investigator’s Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
<= 3.3 Remission, > 3.3 - <= 11 Low, > 11 - <= 26 Moderate, > 26 High"|Baseline, Week 16|Of the 333 subjects in the Run-in period, 326 are included in this analysis using the Last Observation Carried Forward (LOCF) method.||units on a scale||Standard Deviation|Mean
754196|NCT00580840|Secondary|Change From Baseline in DAS28 (Disease Activity Score-28 Items) at Week 16 in All Patients|"DAS28-ESR is calculated using the tender joint count (TJC), swollen joint count (SJC) erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
< 2.6 Remission,
> = 2.6 - < =3.2 Low, > 3.2 - < = 5.1 Moderate, > 5.1 High"|Baseline, Week 16|Of the 333 subjects in the Run-in period, 325 are included in this analysis using the Last Observation Carried Forward (LOCF) method.||units on a scale||Standard Deviation|Mean
754197|NCT00580840|Secondary|Percentage of ACR70 (American College of Rheumatology 70% Improvement) Responders at Week 16 in All Patients|ACR70 responders are subjects with at least 70% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. Missing values were imputed using Non-Responder Imputation (NRI)|Baseline, Week 16|Since Non-Response Imputation (NRI) was used, all 333 subjects in the run-in period are included in this analysis||percentage of subjects|||Number
754198|NCT00580840|Secondary|Percentage of ACR50 (American College of Rheumatology 50% Improvement) Responders at Week 16 in All Patients|ACR50 responders are subjects with at least 50% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. Missing values were imputed using Non-Responder Imputation (NRI)|Baseline, Week 16|Since Non-Response Imputation (NRI) was used, all 333 subjects in the run-in period are included in this analysis||percentage of subjects|||Number
754199|NCT00580840|Secondary|Percentage of ACR20 (American College of Rheumatology 20% Improvement) Responders at Week 16 in All Patients|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. Missing values were imputed using Non-Responder Imputation (NRI)|Baseline, Week 16|Since Non-Response Imputation (NRI) was used, all 333 subjects in the run-in period are included in this analysis||percentage of subjects|||Number
754200|NCT00580840|Primary|Percentage of ACR20 (American College of Rheumatology 20% Improvement) Responders at Week 34 in Patients Randomized at Week 18|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. Missing values were imputed using Non-Responder Imputation (NRI)|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 208 subjects (69 400 mg CZP, 70 200 mg CZP, 69 placebo) are included in this analysis which uses Non-Response Imputation (NRI).||percentage of subjects|||Number
754201|NCT00580853|Secondary|Number of Cigarettes Smoked During the 60 Minute Ad-lib Period|number of cigarettes smoked (range 0-8) during the 60 minute ad-lib period|60 minutes|||number of cigarettes||Standard Error|Mean
754202|NCT00580853|Primary|Latency to Initiate Ad-lib Smoking Session|minutes to start smoking (range 0 to 50 minutes)|0 to 50 minutes|Subsample with high nicotine dependence||minutes||Standard Error|Mean
754203|NCT00580866|Secondary|Disabilities of the Arm, Shoulder and Hand (DASH) Score|Improvement of patient's overall functional outcome will be measured by a standard functional outcome instrument, the DASH Score. The results can range from 0 (no disability) to 100 (worst )|12 months post-operatively|||scores on a scale||95% Confidence Interval|Mean
754204|NCT00580866|Primary|Elbow ROM at 12 Months|The goal of this study is to determine if static progressive splinting eliminates deformity by improving patients' range of motion.|2 weeks, 6 weeks, 3 months, 6 months, 12 months post-operatively|Elbow ROM at 12 months analysis. Data was not collected at 2 weeks, 6 weeks, 3 months, 6 months due to poor enrollment.||degrees||95% Confidence Interval|Mean
754205|NCT00580957|Primary|Insulin Resistance|Glucose infusion rate in mg/kg/min|Last 30 minutes of a two hour insulin clamp|||mg/kg/min||Standard Error|Mean
756037|NCT00591344|Secondary|Beck’s Depression Inventory|This is a self-report rating inventory that measures characteristic attitudes and symptoms of depression.|Obtained during initial evaluation & then every 6 six months to end of 2-yr training period||||||
754206|NCT00580970|Primary|Percentage of Participants With Physician Reported Rectal Toxicity ≥ Grade 2 During the First 2 Years of Radiation Treatment|The primary endpoint of this study was percentage of participants with physician reported rectal toxicity ≥Grade 2 during the first 2 years after treatment. A one sided test will be conducted in order to evaluate reduction of risk from adding Lovastatin. The analysis is using a one-stage design, 5% level of significance, and 83% power.|24 months|The primary endpoint of the study was percentage of participants with physician reported rectal toxicity ≥Grade 2 during the first 2 years after treatment. Only the highest-grade toxicity for each symptom was counted. Symptoms starting in the acute period and unresolved beyond 90 days post treatment are considered late toxicity.||percentage of participants|||Number
754207|NCT00580983|Secondary|The Mean Esophageal Radiotherapy Dose in Patients With Strictures and Without Strictures|To assess the relationships between the mean radiotherapy dose delivered and objectively measured dysphagia.|5 years|||Gray (Gy)||Standard Deviation|Mean
754208|NCT00580983|Primary|Percentage of Participants With Grade 0-1 Observer-rated Dysphagia|To objectively assess dysphagia and aspiration in patients receiving dysphagia/aspiration-sparing IMRT concurrent with chemotherapy, the percentage of participants with observer-rated dysphagia was calculated.|12 months|90 patients were enrolled. Only 80 patients were treated and 7 patients did not complete the 12 month post-Radiation Therapy (RT) swallowing studies. Therefore only 73 patients were analyzed.||percentage of participants|||Number
754209|NCT00581061|Secondary|Side Effects|Number of people who experienced side effects while taking Vesicare, per study protocol.|3 months|||participants|||Number
754210|NCT00581061|Secondary|Compliance|Number of subjects that were in compliance with the study protocol and took medication for at least one month.|3 months|per protocol||participants|||Number
754211|NCT00581061|Primary|Time to Continence|Time in days to achieve pad free urinary continence|12 months|||days||Standard Deviation|Mean
754212|NCT00581100|Secondary|Change From Baseline in Physician Fingernail Grading Assessment Total Score|Physician assessment of disease activity for each fingernail; range: 0 (no disease), 1 (mild disease, 2 (moderate disease), or 3 (severe disease). Total score range = 0-30.|Baseline, Week 24|mITT, N = number of participants with evaluable data.||units on a scale||95% Confidence Interval|Mean
754213|NCT00581100|Secondary|Change From Baseline in Patient Assessment of Nail Psoriasis Activity Visual Analog Scale (VAS)|Patient global assessment of disease activity using a visual analog scale; range: 0 (no nail disease) to 100 (worst possible nail disease).|Baseline, Week 24|mITT, N = number of participants with evaluable data.||units on a scale||95% Confidence Interval|Mean
754214|NCT00581100|Secondary|Change From Baseline in Physician Assessment of Nail Psoriasis Activity Visual Analog Scale (VAS)|Physician global assessment of disease activity using a visual analog scale; range: 0 (no nail disease) to 100 (worst possible nail disease).|Baseline, Week 24|mITT, N = number of participants with evaluable data.||units on a scale||95% Confidence Interval|Mean
754215|NCT00581100|Secondary|Change From Baseline in the Dermatology Life Quality Index (DLQI)|Self-administered questionnaire to measure health-related quality of life (QoL)of adult patients suffering from skin disease; 10 questions concerning patients' perception of impact of their disease over last week encompassing aspects such as symptoms, feelings, daily activities, leisure, work, school, personal relationships and side effects of treatment. Questions scored on a 4-point Likert scale: 0 (not at all/not relevant), 1 (a little), 2 (a lot), and 3 (very much). Scores of individual items (0-3) were added to yield a total score (0-30); higher score = greater impairment of patient's QoL.|Baseline, Week 24|mITT, N = number of participants with evaluable data.||units on a scale||95% Confidence Interval|Mean
754216|NCT00581100|Secondary|Percent of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Mild or Better|Physician Global Assessment (PGA) of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Assessment of mild or better = PGA score of ≤ 2 (mild plaque elevation, mild scaling, and light red coloration).|Baseline, Week 24 or Early Termination|mITT, N = number of participants with evaluable data.||percent of participants|||Number
754217|NCT00581100|Secondary|Percent of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Clear or Almost Clear|Physician Global Assessment (PGA) of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Assessment of clear or almost clear = PGA score of 0 (no evidence), or 1 (minimal/faint).|Baseline, Week 24 or Early Termination|mITT, N = number of participants with evaluable data.||percent of participants|||Number
754218|NCT00581100|Secondary|Change From Baseline in Physician Global Assessment (PGA) of Psoriasis|Physician Global Assessment (PGA) of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease.|Baseline, Week 24|mITT, N = number of participants with evaluable data.||unts on a scale||95% Confidence Interval|Mean
754219|NCT00581100|Secondary|Percent of Participants Achieving a 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score at Week 12 and Week 24|Combined assessment of lesion severity and area affected into single score; range: 0 (no disease) to 72 (maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area was scored by itself and scores were combined for final PASI. For each section percent (%) area of skin involved was estimated: 0 (0%) to 6 (90 – 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).|Week 12 , Week 24|mITT, N = number of participants with evaluable data.||percent of participants|||Number
754339|NCT00574990|Primary|Incident Rate for Communication Events|Observation periods were approximately two-hours long. Some providers were observed more than once. The number of communication events were counted per each observation period.|6 months|Participants were providers who had worked at least one year in the VA and were familiar with the VA's electronic health record, CPRS.||mean events per observation||Standard Deviation|Mean
754220|NCT00581100|Secondary|Percent of Participants Achieving a 50% Improvement in the Psoriasis Area and Severity Index (PASI) Score at Week 12 and Week 24|Combined assessment of lesion severity and area affected into single score; range: 0 (no disease) to 72 (maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area was scored by itself and scores were combined for final PASI. For each section percent (%) area of skin involved was estimated: 0 (0%) to 6 (90 – 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).|Week 12 , Week 24|mITT, N = number of participants with evaluable data.||percent of participants|||Number
754221|NCT00581100|Secondary|Change From Baseline in the Psoriasis Area and Severity Index (PASI) Score|Combined assessment of lesion severity and area affected into single score; range: 0 (no disease) to 72 (maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area was scored by itself and scores were combined for final PASI. For each section percent (%) area of skin involved was estimated: 0 (0%) to 6 (90 – 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).|Baseline, Week 24|mITT, N = number of participants with evaluable data.||units on a scale||95% Confidence Interval|Mean
754222|NCT00581100|Secondary|Percent of Participants Who Achieved a 75% Improvement in the Nail Psoriasis Severity Index (NAPSI) for Overall NAPSI Score at Week 12 and Week 24|NAPSI (matrix + bed score) performed on dorsal views of 8 fingers, excluding thumb; range: 0 to 8. Overall NAPSI score = sum of all fingernail scores; range: 0 to 64. Nails were divided into quadrants and graded for nail matrix and bed psoriasis. Nail Matrix Psoriasis = pitting, leukonychia, red spots in lunula, and/or nail plate crumbling. Nail Bed Psoriasis = onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration, and/or nail bed hyperkeratosis. Range for both scores: 0 (none), 1 (present 1/4 nail), 2 (present 2/4 nail), 3 (present 3/4 nail), and 4 (present 4/4 nail).|Week 12, Week 24|mITT, N = number of participants with evaluable data.||units on a scale|||Number
754223|NCT00581100|Secondary|Percent of Participants Who Achieved a 50% Improvement in the Nail Psoriasis Severity Index (NAPSI) for Overall NAPSI Score at Week 12 and Week 24|NAPSI (matrix + bed score) performed on dorsal views of 8 fingers, excluding thumb; range: 0 to 8. Overall NAPSI score = sum of all fingernail scores; range: 0 to 64. Nails were divided into quadrants and graded for nail matrix and bed psoriasis. Nail Matrix Psoriasis = pitting, leukonychia, red spots in lunula, and/or nail plate crumbling. Nail Bed Psoriasis = onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration, and/or nail bed hyperkeratosis. Range for both scores: 0 (none), 1 (present 1/4 nail), 2 (present 2/4 nail), 3 (present 3/4 nail), and 4 (present 4/4 nail).|Week 12, Week 24|mITT, N = number of participants with evaluable data.||percent of participants|||Number
754224|NCT00581100|Secondary|Percent of Participants Who Achieved a 75% Improvement in the Nail Psoriasis Severity Index (NAPSI) Score for Target Fingernail at Week 12 and Week 24|Target fingernail (highest matrix + bed scores at baseline) divided with imaginary lines into quadrants and graded for nail matrix and nail bed psoriasis. Sum of scores = total score for that nail (0-8). Nail Matrix Psoriasis = pitting, leukonychia, red spots in lunula, and/or nail plate crumbling. Nail Bed Psoriasis = onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration, and/or nail bed hyperkeratosis. Range for both scores: 0 (none), 1 (present in 1/4 nail), 2 (present in 2/4 nail), 3 (present in 3/4 nail), 4 (present in 4/4 nail). Higher scores = more severe psoriasis.|Week 12, Week 24|mITT, N = number of participants with evaluable data.||percent of participants|||Number
754225|NCT00581100|Secondary|Percent of Participants Who Achieved a 50% Improvement in the Nail Psoriasis Severity Index (NAPSI) Score for Target Fingernail at Week 12 and Week 24|Target fingernail (highest matrix + bed scores at baseline) divided with imaginary lines into quadrants and graded for nail matrix and nail bed psoriasis. Sum of scores = total score for that nail (0-8). Nail Matrix Psoriasis = pitting, leukonychia, red spots in lunula, and/or nail plate crumbling. Nail Bed Psoriasis = onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration, and/or nail bed hyperkeratosis. Range for both scores 0-8: 0 (none), 1 (present in 1/4 nail), 2 (present in 2/4 nail), 3 (present in 3/4 nail),4 (present in 4/4 nail). Higher score = more severe psoriasis.|Week 12, Week 24|mITT, N = number of participants with evaluable data.||percent of participants|||Number
754226|NCT00581100|Secondary|Change From Baseline in Overall Nail Psoriasis Severity Index (NAPSI) Score|NAPSI (matrix + bed score) performed on dorsal views of 8 fingers, excluding thumb; range: 0 to 8. Overall NAPSI score = sum of all fingernail scores; range: 0 to 64. Nails were divided into quadrants and graded for nail matrix and bed psoriasis. Nail Matrix Psoriasis = pitting, leukonychia, red spots in lunula, and/or nail plate crumbling. Nail Bed Psoriasis = onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration, and/or nail bed hyperkeratosis. Range for both scores: 0 (none), 1 (present 1/4 nail), 2 (present 2/4 nail), 3 (present 3/4 nail), and 4 (present 4/4 nail).|Baseline, Week 24|mITT, N = number of participants with evaluable data.||units on a scale||95% Confidence Interval|Mean
754227|NCT00581100|Primary|Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score for Target Fingernail|Target fingernail (highest matrix + bed scores at baseline) divided with imaginary lines into quadrants and graded for nail matrix and nail bed psoriasis. Sum of scores = total score for that nail (0-8). Nail Matrix Psoriasis = pitting, leukonychia, red spots in lunula, and/or nail plate crumbling. Nail Bed Psoriasis = onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration, and/or nail bed hyperkeratosis. Range for both scores: 0 (none), 1 (present in 1/4 nail), 2 (present in 2/4 nail), 3 (present in 3/4 nail), 4 (present in 4/4 nail). Higher scores = more severe psoriasis.|Baseline, Week 24|Modified Intent-to-Treat (mITT) population: all randomized participants who received at least one dose of study medication, and provided baseline and post-baseline data. N = number of participants with evaluable data.||units on a scale||95% Confidence Interval|Mean
754228|NCT00581113|Primary|Increase in the Bi-dimensional Tumor Area for Any of the Tracked Brain Metastases or the Appearance of Any New Brain Metastases on a Follow-up MRI.|Brain metastases bi-dimensional area|12 months post RT|Not enough patients were enrolled to allow for any meaningful analysis.|||||
754229|NCT00581113|Secondary|Increase in the Bi-dimensional Tumor Area for Any of the Tracked Brain Metastases or the Appearance of Any New Brain Metastases on a Follow-up MRI.|Increase in the bi-dimensional tumor area for any of the tracked brain metastases or the appearance of any new brain metastases on a follow-up MRI.|12 months after end of radiation therapy|Study terminated early due to poor accrual|||||
754242|NCT00574067|Secondary|HIV Risk Behavior|Number of times had sex without using a condom during the past year|1 year|||times||Standard Deviation|Mean
754243|NCT00574067|Secondary|HIV Risk Behavior Needle Sharing|Number of times shared a needle during the past year|1 year|||times||Standard Deviation|Mean
754244|NCT00574067|Secondary|Employment Status|Number of days employed during the past year|1 year|||days||Standard Deviation|Mean
754245|NCT00574067|Secondary|Criminal Activity|Days of crime during the past 30 days|1 year|||days||Standard Deviation|Mean
754246|NCT00574067|Secondary|Number of Days of Cocaine Use|Number of days used cocaine during the past 30 days.|1 year|||days||Standard Deviation|Mean
754247|NCT00574067|Primary|Drug Abuse Treatment Entry and Retention in the Community|entered community treatment within 10 days of release from prison (yes vs. no)|1 year|||participants|||Number
754248|NCT00574067|Primary|Number of Days of Heroin Use|mean days used heroin during the past 30 days|1 year|||days||Standard Deviation|Mean
754251|NCT00574145|Secondary|Intensity of Anxiety and Depression|Measured on the Hospital Anxiety and Depression Scale, 14 items on a 4-point scale scored from 0 = not at all (best feeling) to 3 = very often (worst feeling). Scores are summed and range from a minimum of 0 (no anxiety or depression) to 42 (worst anxiety or depression)and a median for each arm is determined at the specified timepoints.|baseline and off-radiation at 5 to 7 weeks|Arm A: 1 patient withdrew at 2 days, 1 patient withdrew at 5 days. Arm B: 1 patient withdrew at 4 weeks||units on a scale||Full Range|Median
754252|NCT00574145|Secondary|Quality of Life as Measured by the Functional Assessment of Cancer Therapy-Breast Form (FACT-B)|36 items that measure general quality of life (27 items) and specific breast cancer concerns (9 items) on a 5-point rating scale with 0 = not at all to 4 = very much. Minimum (worst quality of life) possible score = 0 and maximum (best quality of life) possible score = 144. Physical and emotional well-being scores were reverse coded and sub scale scores were summed. Median scores for baseline and at 6 weeks were determined|baseline and 6 weeks|Arm A:1 patient was accidentally notified of group assignment before final data collected, 2 patients withdrew (1 at 2 days), 1 at 5 days. )Arm B: 1 patient withdrew at 4 weeks||units on a scale||Full Range|Median
754253|NCT00574145|Primary|Fatigue Using the Brief Fatigue Inventory (BFI)|9-items with an 11-point rating scale measures intensity of fatigue (3 items, 0 = no fatigue to 10 = fatigue as bad as you can imagine) and interference of fatigue on daily life (6 items, 0 = does not interfere to 10 = completely interferes. Each participant's score is summed with a possible minimum score of 0 and a possible maximum score of 90. A mean score was then determined.|6 weeks|Patients who completed 5 of 8 maximum collection points. Arm A: 1 patient withdrew at 2 days, 1 patient withdrew at 5 days. Arm B: 1 patient withdrew at 4 weeks||units on a scale||Standard Deviation|Mean
754254|NCT00574171|Primary|Response Rate of Lapatinib/Capecitabine.||duration of study; on average 1 year|||participants|||Number
778252|NCT00775190|Primary|Amount of Bleeding|Measures how light or heavy the menstrual flow on a 1 to 3 Likert scale. (Light, Medium, Heavy).|6 Months|Study Terminated with no data analysis.|||||
754255|NCT00574249|Secondary|Percent Change in Short Form 36 Health Survey (SF-36) Physical Component Score (PCS) at Week 8 Compared With Baseline (Week 0)|Short Form 36 Health Survey (SF-36) Physical Component Score (PCS) is a participant-reported outcome that employs a questionnaire that asks for the participant's views about their health. Percent change at Week 8 is calculated as (Week 8 SF-36 PCS minus Week 0 SF-36 PCS) divided by Week 0 SF-36 PCS. Positive percent change in score indicates improvement, with best improvement 100%.|Week 0 and Week 8|Of the ITT analysis set, participants with an SF-36 score both at Baseline and Week 8. Imputation of missing values using LOCF. Participants with a zero score at Baseline were not included in the analysis of percent change.||percent change in score||Standard Deviation|Mean
754256|NCT00574249|Secondary|Percent Change in Short Form 36 Health Survey (SF-36) Physical Component Score (PCS) at Week 16 Compared With Baseline (Week 0)|Short Form 36 Health Survey (SF-36) Physical Component Score (PCS) is a participant-reported outcome that employs a questionnaire that asks for the participant's views about their health. Percent change at Week 16 is calculated as (Week 16 SF-36 PCS minus Week 0 SF-36 PCS) divided by Week 0 SF-36 PCS. Positive percent change in score indicates improvement, with best improvement 100%.|Week 0 and Week 16|Of the ITT analysis set, participants with an SF-36 score at both Baseline and Week 16. Imputation of missing values using LOCF. Participants with a zero score at Baseline were not included in the analysis of percent change.||percent change in score||Standard Deviation|Mean
754257|NCT00574249|Secondary|Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 12 Compared With Baseline (Week 0)|DLQI is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which (i.e., how much) the subject's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. Total score range: 0 (best) to 30 (worst). Negative change and percent change from Baseline indicate improvement, with best improvement -100%.|Week 0 and Week 12|Of the ITT analysis set, participants with DLQI scores at both Baseline and Week 12. Imputation of missing values using LOCF. Participants with a zero score at Baseline were not included in analysis of percent change.||percent change in score||Standard Deviation|Mean
754258|NCT00574249|Secondary|Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 8 Compared With Baseline (Week 0)|DLQI is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which (i.e., how much) the subject's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. Total score range: 0 (best) to 30 (worst). Negative change and percent change from Baseline indicate improvement, with best improvement -100%.|Week 0 and Week 8|Of the ITT analysis set, participants with DLQI scores at both Baseline and Week 8. Imputation of missing values using LOCF. Participants with a zero score at Baseline were not included in analysis of percent change.||percent change in score||Standard Deviation|Mean
754259|NCT00574249|Secondary|Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 4 Compared With Baseline (Week 0)|DLQI is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which (i.e., how much) the subject's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. Total score range: 0 (best) to 30 (worst). Negative change and percent change from Baseline indicate improvement, with best improvement -100%.|Week 0 and Week 4|Of the ITT analysis set, participants with DLQI scores at both Baseline and Week 4. Imputation of missing values using LOCF. Participants with a zero score at Baseline were not included in the analysis of percent change.||percent change in score||Standard Deviation|Mean
754260|NCT00574249|Secondary|Percent Change in the Dermatology Life Quality Index (DLQI) Total Score at Week 2 Compared With Baseline (Week 0)|DLQI is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which (i.e., how much) the subject's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. Total score range: 0 (best) to 30 (worst). Negative change and percent change from Baseline indicate improvement, with best improvement -100%.|Week 0 and Week 2|Of the ITT analysis set, participants with DLQI scores at both Baseline and Week 2. Imputation of missing values using LOCF. Participants with a zero score at Baseline were not included in analysis of percent change.||percent change in score||Standard Deviation|Mean
754261|NCT00574249|Secondary|Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 16 Compared With Baseline (Week 0)|DLQI is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which (i.e., how much) the subject's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. Total score range: 0 (best) to 30 (worst). Negative change and percent change from Baseline indicate improvement, with best improvement -100%.|Week 0 and Week 16|Of the ITT analysis set, participants with DLQI scores both at Baseline and Week 16. Imputation of missing values using last observation carried forward (LOCF). Participants with a zero score at Baseline were not included in analysis of percent change.||percent change in score||Standard Deviation|Mean
754262|NCT00574249|Secondary|Percentage of Participants Achieving a Physicians Global Assessment (PGA) Response of Clear or Minimal at Week 16|PGA is a physician's assessment of severity of disease (grading lesion severity). PGA scores range from 0 (best) to 6 (worst): on the 6-point scale, a score of 0 = Clear and a score of 6 = Very Severe for the lesion severity. PGA Clear (0) is no plaque elevation over normal skin and no scale with or without erythema. Minimal (1) is possible plaque elevation but difficult to ascertain a slight elevation above normal skin. Percentage of participants: 0% to 100% (best).|Week 16|ITT analysis. Imputation of missing values at Week 16 as not achieving PGA of Clear or Minimal.||percentage of participants|||Number
754263|NCT00574249|Secondary|Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 12|PGA is a physician's assessment of severity of disease (grading lesion severity). PGA scores range from 0 (best) to 6 (worst): on the 6-point scale, a score of 0 = Clear and a score of 6 = Very Severe for the lesion severity. PGA Clear (0) is no plaque elevation over normal skin and no scale with or without erythema. Minimal (1) is possible plaque elevation but difficult to ascertain a slight elevation above normal skin. Percentage of participants: 0% to 100% (best).|Week 12|ITT analysis. Imputation of missing values at Week 12 as not achieving PGA of Clear or Minimal.||percentage of participants|||Number
756038|NCT00591344|Secondary|Epworth Sleepiness Scale|The Epworth Sleepiness Scale is used to determine the level of daytime sleepiness.|Obtained during initial evaluation & then every 6 six months to end of 2-yr training period||||||
754264|NCT00574249|Secondary|Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 8|PGA is a physician's assessment of severity of disease (grading lesion severity). PGA scores range from 0 (best) to 6 (worst): on the 6-point scale, a score of 0 = Clear and a score of 6 = Very Severe for the lesion severity. PGA Clear (0) is no plaque elevation over normal skin and no scale with or without erythema. Minimal (1) is possible plaque elevation but difficult to ascertain a slight elevation above normal skin. Percentage of participants: 0% to 100% (best).|Week 8|ITT analysis. Imputation of missing values at Week 8 as not achieving PGA of Clear or Minimal.||percentage of participants|||Number
754265|NCT00574249|Other Pre-specified|Percent Change in Nail Psoriasis Severity Index (NAPSI) at Week 16.|NAPSI is a sum of 2 scores that grade nail matrix psoriasis (based on presence/absence of pitting, leukonychia, red spots in the lunula, and nail plate crumbling) and nail bed psoriasis (based on presence/absence of onycholysis splinter hemorrhages, oil drop [salmon patch] discoloration, and nail bed hyperkeratosis). Each fingernail is given a single score based on presence of psoriasis in quadrant of nail: 0 (none) to 4 (present in 4/4 nail quadrants). Score range: 0 (best) to 80 (worst). Negative change and percent change from Baseline indicate improvement.|Week 0 and Week 16|Of the ITT analysis set, participants with a NAPSI score at both Baseline and Week 16. Imputation of missing values using LOCF. Subjects with a zero score at Baseline were not included in analysis of percent change.||percent change in score||Inter-Quartile Range|Median
754266|NCT00574249|Other Pre-specified|Percent Change in Psoriasis Scalp Severity Index (PSSI) From Baseline to Week 16.|PSSI is a physician assessment of clinical symptoms of scalp psoriasis. Computed as the sum of scores for erythema, induration, and desquamation (1 = absent; 4 = severest possible) multiplied by involved area (0 = 0%; 6 = 90-100%). Total score range: 0 (best) to 72 (worst). Negative change and percent change from Baseline indicate improvement.|Week 0 and Week 16|Of the ITT analysis set, participants with a PSSI score at both Baseline and Week 16. Imputation of missing values using LOCF. Subjects with a zero score at Baseline were not included in analysis of percent change.||percent change in score||Inter-Quartile Range|Median
754267|NCT00574249|Secondary|Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 4|PGA is a physician's assessment of severity of disease (grading lesion severity). PGA scores range from 0 (best) to 6 (worst): on the 6-point scale, a score of 0 = Clear and a score of 6 = Very Severe for the lesion severity. PGA Clear (0) is no plaque elevation over normal skin and no scale with or without erythema. Minimal (1) is possible plaque elevation but difficult to ascertain a slight elevation above normal skin. Percentage of participants: 0% to 100% (best).|Week 4|ITT analysis. Imputation of missing values at Week 4 as not achieving PGA of Clear or Minimal.||percentage of participants|||Number
754268|NCT00574249|Secondary|Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 2|PGA is a physician's assessment of severity of disease (grading lesion severity). PGA scores range from 0 (best) to 6 (worst): on the 6-point scale, a score of 0 = Clear and a score of 6 = Very Severe for the lesion severity. PGA Clear (0) is no plaque elevation over normal skin and no scale with or without erythema. Minimal (1) is possible plaque elevation but difficult to ascertain a slight elevation above normal skin. Percentage of participants: 0% to 100% (best).|Week 2|ITT analysis. Imputation of missing values at Week 2 as not achieving PGA of Clear or Minimal.||percentage of participants|||Number
754269|NCT00574249|Secondary|Percentage of Participants With a PASI100 Response at Week 16 Compared With Baseline (Week 0)|PASI100 is defined as at least a 100% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0.0 (best) to 72.0 (worst) with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 16 PASI score) divided by Week 0 PASI score. Positive percent decreases indicate improvement, with best improvement 100%. The outcome measure is the percentage of participants who had at least a 100% PASI score decrease.|Week 0 and Week 16|ITT analysis; participants with a missing PASI assessment at Week 16 were imputed as nonresponders.||percentage of participants|||Number
754270|NCT00574249|Secondary|Percentage of Participants With a PASI90 Response at Week 16 Compared With Baseline (Week 0)|PASI90 is defined as at least a 90% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0.0 (best) to 72.0 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 16 PASI score) divided by Week 0 PASI score. Positive percent decreases indicate improvement, with best improvement 100%. The outcome measure is the percentage of participants who had at least a 90% PASI score decrease.|Week 0 and Week 16|ITT analysis; participants with a missing PASI assessment at Week 16 were imputed as nonresponders.||percentage of participants|||Number
754271|NCT00574249|Secondary|Percentage of Participants With a PASI50 Response at Week 16 Compared With Baseline (Week 0)|PASI50 is defined as at least a 50% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0.0 (best) to 72.0 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 16 PASI score) divided by Week 0 PASI score. Positive percent decreases indicate improvement, with best improvement 100%. The outcome measure is the percentage of participants who had at least a 50% PASI score decrease.|Week 0 and Week 16|ITT analysis; participants with a missing PASI assessment at Week 16 were imputed as nonresponders.||percentage of participants|||Number
754272|NCT00574249|Primary|Percentage of Participants Who Achieve a PASI75 Response at Week 16 Compared With Baseline (Week 0)|PASI75 is defined as at least a 75% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0.0 (best) to 72.0 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 16 PASI score) divided by Week 0 PASI score. Positive percent decreases indicate improvement, with best improvement being 100%. The outcome measure is the percentage of participants who had at least a 75% PASI score decrease.|Week 0 and Week 16|ITT analysis; participants with a missing PASI assessment at Week 16 were imputed as nonresponders.||percentage of participants|||Number
754273|NCT00574275|Secondary|Number of Participants With Anti-drug Antibodies|Anti-drug antibodies in the participants blood sample were detected using a validated immunoassay. The validated lower limit of detection (LLOD) for the assay was about 5.4 ng/mL in the absence of aflibercept and about 25.2 ng/mL in the presence of 20 μg/mL of aflibercept.|Up to 90 days post last dose of study drug|Safety population with samples available for analysis||participants|||Number
754274|NCT00574275|Secondary|Safety-Number of Participants With Adverse Events (AE)|All AEs regardless of seriousness or relationship to study treatment, spanning from the signature of informed consent until 30 days after the last administration of study treatment, were recorded. The number of participants with all treatment emergent adverse events (TEAE), serious adverse events (SAE), TEAE leading to death, and TEAE leading to permanent treatment discontinuation are reported.|up to 30 days after treatment discontinuation. SAEs and related AEs were followed till resolved or stabilized.|The safety population included all randomized participants who were administered at least 1 dose of study medications (placebo, aflibercept, or gemcitabine). For safety analyses, participants were analyzed according to the treatment received.||participants|||Number
754275|NCT00574275|Secondary|Clinical Benefit|"Clinical benefit was to be assessed in all participants by time to symptom worsening (TTSW), evaluated from the time of randomization to symptom worsening, as well as by improvement in tumor related symptoms.
However, this analysis was not performed, as the study was terminated due to futility."|From the first randomization until the end of the study data cutoff date (approximately 2 years)|Since the study was terminated due to futility, analysis for this endpoint was not performed.|||||
754276|NCT00574275|Secondary|Objective Response Rate (ORR) Assessed by the Investigators According to RECIST Criteria|"Objective response (OR) included complete response [CR] and partial response [PR]. OR was to be assessed by the Investigators according to RECIST criteria, and confirmed by repeating tumor imaging at least 4 weeks after the first radiological documentation of response.
CR would reflect the disappearance of all tumor lesions and PR would reflect a defined reduction of tumor burden.
However, OR analysis was not performed, as the study was terminated due to futility."|From the first randomization until the end of the study data cutoff date (approximately 2 years)|Since the study was terminated due to futility, this analysis was not performed.|||||
754277|NCT00574275|Secondary|Progression Free Survival (PFS) Based on Response Evaluation Criteria in Solid Tumors [RECIST] Criteria|"PFS was the time interval from the date of registration to the date of progression, or death from any cause if it occurs before tumor progression is documented. Tumor progression was assessed using RECIST criteria, by which progression was a pre-defined increase in the size of existing tumors or appearance of one or more new tumors.
If a participant did not progress or die, the progression was censored to the date of the last valid tumor assessment or data cut-off, whichever was earlier.
Median PFS time was estimated from Kaplan-Meier Plots."|From the first randomization until the end of study data cutoff date (approximately 2 years)|Intent-to-treat (ITT) population, which included all randomized participants.||months|Participants|95% Confidence Interval|Median
754278|NCT00574275|Primary|Overall Survival (OS)|"OS is the time interval from the date of randomization to the date of death due to any cause. If death was not observed during the study, data on OS were censored at the earlier of the last date participant was known to be alive, or the study data cutoff date (11 September 2009).
OS time was estimated from Kaplan-Meier Plots."|From the first randomization until the end of study data cutoff date (approximately 2 years)|Intent-to-treat (ITT) population, which included all randomized participants.||months|Participants|95% Confidence Interval|Median
754279|NCT00574288|Secondary|Part 2: Median Overall Survival|Overall Survival (OS) was defined as the number of days from administration of the first infusion (Day 1) to date of death. Median Overall Survival was estimated by using the Kaplan-Meier method.|Up to Week 27|All-Treated Analysis Set included all enrolled participants who received at least 1 dose of study drug.||months||95% Confidence Interval|Median
754280|NCT00574288|Secondary|Part 2: Time to Response|Time to first response was defined as the time from the date of first dose of daratumumab to the date of initial documentation of a response (PR or better). Time to best response was defined as the time between the date of first dose of daratumumab and the date of the initial evaluation of the best response (PR or better) to treatment. Time to VGPR (very good partial response) was defined as the time from the date of first dose of daratumumab to the date of initial documentation of VGPR response. VGPR: serum and urine M-protein detected by immunofixation but not electrophoresis, greater than (>) 90 percent in serum M-protein+urine, M-protein level less than (<) 100 milligram per 24 hour (mg/24hour). The Kaplan-Meier method was used to estimate time to response.|Up to Week 27|All-Treated Analysis Set included all enrolled participants who received at least 1 dose of study drug. Here 'n' (Number of Participants Analyzed) signifies number of participants analyzed at specific time point.||months||Standard Deviation|Mean
754281|NCT00574288|Secondary|Part 2: Median Progression-Free Survival|Progression free survival (PFS) was defined as the time between the date of first dose of daratumumab and either disease progression or death, whichever occurs first.|Up to Week 27|All-Treated Analysis Set included all enrolled participants who received at least 1 dose of study drug.||months||95% Confidence Interval|Median
754282|NCT00574288|Secondary|Part 2: Duration of Response as Assessed Using the Method of Kaplan-Meier|Duration of response was calculated from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the International Myeloma Working Group (IMWG) criteria.|Up to Week 27|Subset of All-Treated Analysis Set included those who had overall response in Part 2.||months||95% Confidence Interval|Number
754283|NCT00574288|Secondary|Part 2: Median Time to Progression (TTP)|TTP was defined as the number of days from the date of first infusion (Day 1) to the date of first record of disease progression. Disease progression (IMWG criteria): increase of >=25 percent (%) from lowest response level in Serum M-component and/or (the absolute increase must be >=0.5 g/dL) Urine M-component and/or (the absolute increase must be >=200 mg/24 hour; only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain levels. The absolute increase must be >10 mg/dL; Bone marrow plasma cell percentage: the absolute % must be >=10 %; Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder. Median TTP was estimated by using the Kaplan-Meier method.|Up to Week 27|All-Treated Analysis Set included all enrolled participants who received at least 1 dose of study drug.||months||95% Confidence Interval|Median
754510|NCT00583661|Primary|Efficacy of the EXCOR® Pediatric Was Estimated by Showing Survival of All Participants Who Were Supported by the Device.|Efficacy of the EXCOR® Pediatric was estimated by showing survival of all participants who were supported by the device.|Participants were followed while on device support, an average of 58 days|All subjects implanted with the device were included in this analysis.||participants|||Number
754284|NCT00574288|Secondary|Part 1: Median Time to Response|Time to first response was defined as the time from the date of first dose of daratumumab to the date of initial documentation of a response (PR or better). Time to best response was defined as the time between the date of first dose of daratumumab and the date of the initial evaluation of the best response (PR or better) to treatment. Kaplan-Meier method was used to estimate the distribution of time to response and time to best response.|Up to Week 28|All-Treated Analysis Set included all enrolled participants who received at least 1 dose of study drug. For Part 1, only participants treated with >= 4 mg/kg daratumumab were used for efficacy analyses and less than (<) 4 mg/kg doses were considered under the therapeutic levels.||months||95% Confidence Interval|Median
754285|NCT00574288|Primary|Percentage of Participants With Overall Response Rate|Overall response defined as percentage of participants who achieved complete response (CR), very good partial response (VGPR) or partial response (PR). Per IMWG criteria, CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and less than (<)5 percent plasma cells in bone marrow; PR: greater than or equal to (>=) 50 percent reduction of serum M-protein and reduction in 24hour urinary M-protein by >= 90 percent; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90 percent or greater reduction in serum M-protein plus urine M-protein level less than (<) 100 milligram (mg) per 24 hour.|Up to Week 28 (for Part 1) and Week 27 (for Part 2)|All-Treated Analysis Set included all enrolled participants who received at least 1 dose of study drug. For Part 1, only participants treated with >= 4 mg/kg daratumumab were used for efficacy analyses and less than (<) 4 mg/kg doses were considered under the therapeutic levels.||percentage of participants||95% Confidence Interval|Number
754286|NCT00574288|Primary|Number of Participants With Adverse Events|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Up to Week 28 (for Part 1) and Up to Week 27 (for Part 2)|All-Treated Analysis Set included all enrolled participants who received at least 1 dose of study drug.||participants|||Number
754287|NCT00574340|Primary|Percent Changes in Endothelial Function as Measured by Flow Mediated Dilation by 2D Doppler Ultrasound on Day 2|A measure of the baseline arterial dilation on day 2 is compared to the post intervention measure of dilation of the brachial artery on Day 2.|baseline on day 2 and ~6 hours later at end of glucose clamp period|Flow mediated dilation of the brachial artery||percentage of change||Standard Error|Mean
754288|NCT00574405|Secondary|Patient Satisfaction With Mode of Therapy and Patient Compliance With Treatment Recommendations.||12 months||||||
754289|NCT00574405|Secondary|Frequency of Adverse Glycemic Consequences, i.e., Frequency of Hypoglycemia, Severe Hyperglycemia or Ketosis.||12 months||||||
754290|NCT00574405|Secondary|Changes in Daily Insulin Requirements Over Time||12 months||||||
754291|NCT00574405|Secondary|Changes in Glycemic Control, as Assessed by the Change in Hemoglobin A1c and Variations in Daily Blood Glucose Measurements (Fasting BG and CGMS) From Day 1 of Treatment to Month 12 of Treatment.||12 months||||||
754292|NCT00574405|Primary|Change in Mixed-meal-stimulated Peak C-peptide Value (Via Mixed-meal Tolerance Test) After 12 Months of Insulin Pump Therapy, Compared With MDI.||12 months|Per protocol||ng/mL||Standard Deviation|Mean
754293|NCT00574548|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC|Systemic events reported using an electronic diary. Systemic events are any fever ≥38 degrees Celsius [C], fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized muscle pain (new muscle pain), aggravated generalized muscle pain (aggravated muscle pain), new generalized joint pain (new joint pain), and aggravated generalized joint pain (aggravated joint pain). Participants may be represented in more than 1 category.|14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)|Safety population; N=number of participants with any systemic event; (n)=number of participants with known values for 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC, respectively. Participants may be represented in more than 1 category.||percentage of participants|||Number
754294|NCT00574548|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)|Systemic events reported using an electronic diary. Systemic events are any fever ≥38 degrees Celsius [C], fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized muscle pain (new muscle pain), aggravated generalized muscle pain (aggravated muscle pain), new generalized joint pain (new joint pain), and aggravated generalized joint pain (aggravated joint pain). Participants may be represented in more than 1 category.|14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)|Safety population; N=number of participants with any systemic event; (n)=number of participants with known values for 23vPS and 13vPnC / 23vPS, respectively. Participants may be represented in more than 1 category.||percentage of participants|||Number
754295|NCT00574548|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)|Systemic events reported using an electronic diary. Systemic events are any fever ≥38 degrees Celsius [C], fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized muscle pain (new muscle pain), aggravated generalized muscle pain (aggravated muscle pain), new generalized joint pain (new joint pain), and aggravated generalized joint pain (aggravated joint pain). Participants may be represented in more than 1 category.|14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)|Safety population; N=number of participants with any systemic event; (n)=number of participants with known values for 13vPnC and 23vPS / 13vPnC , respectively. Participants may be represented in more than 1 category.||percentage of participants|||Number
754340|NCT00575016|Secondary|Change From Baseline in Maximum Detrusor Pressure (MDP)|Change from baseline in MDP during first involuntary detrusor contraction at week 6. MDP represents the maximum pressure (peak amplitude) in the bladder during the first involuntary contraction of the bladder muscle. The greater the negative number change from baseline, the better the improvement.|Baseline, Week 6|Modified Intent-To-Treat: defined as all patients who were randomized (started study) and received treatment||Centimeters of water (cm H2O)||Standard Deviation|Mean
754296|NCT00574548|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)|Systemic events reported using an electronic diary. Systemic events are any fever ≥38 degrees Celsius [C], fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized muscle pain (new muscle pain), aggravated generalized muscle pain (aggravated muscle pain), new generalized joint pain (new joint pain), and aggravated generalized joint pain (aggravated joint pain). Participants may be represented in more than 1 category.|14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)|Safety population; N=number of participants with any systemic event; (n)=number of participants with known values for 13vPnC and 13vPnC / 13vPnC, respectively. Participants may be represented in more than 1 category.||percentage of participants|||Number
754297|NCT00574548|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS|Systemic events reported using an electronic diary. Systemic events are any fever ≥38 degrees Celsius [C], fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized muscle pain (new muscle pain), aggravated generalized muscle pain (aggravated muscle pain), new generalized joint pain (new joint pain), and aggravated generalized joint pain (aggravated joint pain). Participants may be represented in more than 1 category.|14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1])|Safety population; N=number of participants with any systemic event; (n)=number of participants with known values for 13vPnC and 23vPS, respectively. Participants may be represented in more than 1 category.||percentage of participants|||Number
754298|NCT00574548|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC|Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters [cm]; Moderate (5.1 to 10.0 cm); Severe (>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating); Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).|14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)|Safety population; N=number of participants with any local reaction; (n)=number of participants with known values for 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC, respectively. Participants may be represented in more than 1 category.||percentage of participants|||Number
754299|NCT00574548|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)|Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters [cm]); Moderate (5.1 to 10.0 cm); Severe (>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating); Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).|14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)|Safety population; N=number of participants with any local reaction; (n)=number of participants with known values for 23vPS and 13vPnC / 23vPS, respectively. Participants may be represented in more than 1 category.||percentage of participants|||Number
754300|NCT00574548|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)|Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters [cm]; Moderate (5.1 to 10.0 cm); Severe (>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating); Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).|14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)|Safety population; N=number of participants with any local reaction; (n)=number of participants with known values for 13vPnC and 23vPS / 13vPnC, respectively. Participants may be represented in more than 1 category.||percentage of participants|||Number
754301|NCT00574548|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)|Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters [cm]; Moderate (5.1 to 10.0 cm); Severe (>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating); Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).|14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)|Safety population; N=number of participants with any local reaction; (n)=number of participants with known values for 13vPnC and 13vPnC / 13vPnC, respectively. Participants may be represented in more than 1 category.||percentage of participants|||Number
754302|NCT00574548|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS|Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters [cm]; Moderate (5.1 to 10.0 cm); Severe (>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating); Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).|14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)|Safety population includes all participants who receive at least 1 dose of study vaccine. N=number of participants with any local reaction; (n)=number of participants with known values for 13vPnC and 23vPS, respectively. Participants may be represented in more than 1 category.||percentage of participants|||Number
754303|NCT00574548|Other Pre-specified|Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 23vPS / 13vPnC (Year 1) Versus 13vPnC (Year 0)|Antibody geometric mean titers as measured by opsonophagocytic assays (OPA) for 12 common pneumococcal serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|1 month after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)|Evaluable immunogenicity population. GMTs were calculated using all participants with available data for the specified blood draw.||geometric mean titer||95% Confidence Interval|Geometric Mean
754304|NCT00574548|Secondary|Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 13vPnC (Year 0)|Antibody geometric mean titers as measured by opsonophagocytic assays (OPA) for 12 common pneumococcal serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|1 month after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)|Evaluable immunogenicity population. GMTs were calculated using all participants with available data who had determinate assay values at both the postvaccination 1 (13vPnC; Year 0) and postvaccination 2 (13vPnC / 23vPS; Year 1) time points.||geometric mean titer||95% Confidence Interval|Geometric Mean
754305|NCT00574548|Secondary|Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Year 1) Versus 13vPnC (Year 0)|Antibody geometric mean titers as measured by opsonophagocytic assays (OPA) for the pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). The 6A pneumococcal serotype is specific to 13vPnC. Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|1 month after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)|Evaluable immunogenicity population. GMTs were calculated using all participants with available data who had determinate assay values at both the postvaccination 1 (13vPnC; Year 0) and postvaccination 2 (13vPnC / 13vPnC; Year 1) time points.||geometric mean titer||95% Confidence Interval|Geometric Mean
754306|NCT00574548|Primary|Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS Versus 23vPS / 13vPnC (Year 1)|Antibody geometric mean titers as measured by opsonophagocytic assays (OPA) for 12 common pneumococcal serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)|Evaluable immunogenicity population. GMTs were calculated using all participants with available data for the specified blood draw.||geometric mean titer||95% Confidence Interval|Geometric Mean
754307|NCT00574548|Primary|Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 23vPS (Year 0)|Antibody geometric mean titers as measured by opsonophagocytic assays (OPA) for 12 common pneumococcal serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|1 month after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)|Evaluable immunogenicity population: participants who were eligible for the study, adhered to protocol requirements, had valid and determinate assay results, and had no major protocol violations. GMTs were calculated using all participants with available data for the specified blood draw.||geometric mean titer||95% Confidence Interval|Geometric Mean
754308|NCT00574704|Secondary|Safety and Tolerability of the Study Treatment by Collection of Adverse Events||about 30 min. at each visit||||||
754309|NCT00574704|Primary|Conjunctival Provocation Test (CPT) With House Dust Mite Allergen Solutions. Change of Median Individual Allergen Tolerance Compared to Baseline (Factor of Increase in Allergen Concentration to Induce a Threshold CPT Score ≥ 2)|"The outcome measure is a conjunctival provocation test (CPT) with house dust mite allergen solutions. CPT score was measured as a sum of the following assessed symptoms: conjunctival hyperemia, tearing, itching, burning and swelling of eyelids. Each of the assessed symptom could be absent (0), mild (1 point), moderate (2 points) or severe (3 points). The provocation tests started with the maximal dilution of the allergen 1:1000. If the sum of the reached CPT score was <10 points, the test continued with the next dilution step 1:100. This procedure was repeated until patients reached the CPT score ≥ 10 points or the provocation solution reached the maximal concentration 1:1 (undiluted).
The outcome is then given as the change of median individual allergen tolerance at month two compared to baseline. The change is expressed as a factor of increase in allergen concentration to induce a threshold CPT score ≥ 2."|baseline versus 2 months after baseline|||Factor of Increased Allergen Tolerance||Inter-Quartile Range|Median
754310|NCT00574795|Secondary|Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose|GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|one month after the toddler dose (at 12-15 months of age)|Evaluable immunogenicity population had valid and determinate assay results, and had no other major protocol violations.||μg/mL||95% Confidence Interval|Geometric Mean
754311|NCT00574795|Secondary|Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose|Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥ 0.35 μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|one month after the toddler dose (at 12 - 15 months of age)|Evaluable immunogenicity population had valid and determinate assay results, and had no other major protocol violations.||percentage of participants||95% Confidence Interval|Number
754312|NCT00574795|Secondary|Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the 3-Dose Infant Series|GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|one mone month after 3-dose infant series (at 7 months of age)|Evaluable immunogenicity population had valid and determinate assay results, and had no other major protocol violations.||μg/mL||95% Confidence Interval|Geometric Mean
754313|NCT00574795|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events|Systemic events (fever ≥ 37.5 degrees Celsius [C], fever ≥ 38 C but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased appetite, irritability, increased sleep, decreased sleep, hives, use of medication to treat symptoms, and use of medication to prevent symptoms) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 7 days after each dose|The safety population included all subjects who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.||percentage of participants|||Number
754314|NCT00574795|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Local Reactions|Local reactions were collected using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.|Within 7 days after each dose|The safety population included all participants who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.||percentage of participants|||Number
754315|NCT00574795|Primary|Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the 3-Dose Infant Series|Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥ 0.35 μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|one month after 3-dose infant series (at 7 months of age)|Evaluable immunogenicity population had valid and determinate assay results and had no other major protocol violations.||percentage of participants||95% Confidence Interval|Number
754316|NCT00574834|Primary|Changes in Insulin Sensitivity|Measures of change in endogenous glucose production from baseline to final 30 minutes of clamp studies after 6 months of treatment.|6 months|||mg/kg/min||Standard Error|Mean
754317|NCT00574847|Primary|Percentage of Participants With Overall Mental Stress-induced Myocardial Ischemia (MSIMI)|MSIMI is defined by the following: compared to rest, 1) any development of new abnormal wall motion; 2) reduction of LVEF 8% and/or; 3) deviation (depression or elevation) of ST-segment of ECG in 2 or more leads lasting for 3 consecutive beats, occurring during at least one of the 3 mental stress tasks.|week 6|Subjects who completed.||percentage of participants|||Number
754318|NCT00574847|Secondary|Exercise Stressed-induced Myocardial Ischemia (ESIMI)|End point values adjusted for baseline values age and sex.|6 week|ITT, 7 subject excluded from analysis due to missing data.||percentage of change||95% Confidence Interval|Number
754319|NCT00574847|Secondary|Spielberger State-Trait Anxiety Inventory Scales (STAI)|STAI measures anxiety. The questionnaire asks the patients how they feel and allows them to respond on a frequency scale that ranges from 1(not at all) to 4(almost always/very much so). Scores range from 20-80 and the higher the score the greater the anxiety level. This applies to both the Trait and State scales. End point values adjusted for baseline values age and sex.|6 weeks|ITT||units on a scale||95% Confidence Interval|Mean
754320|NCT00574847|Secondary|Cook-Medley Hostility (Ho) Hostile Affect Sub-scale|hostile affect, 0 to 5 (higher score=greater levels of hostile affect). End point values adjusted for baseline values age and sex.|6 weeks|ITT, 1 subject excluded from analysis due to missing data.||units on a scale||95% Confidence Interval|Mean
754321|NCT00574847|Secondary|Cook-Medley Hostility (Ho) Scale|Score ranges: hostility, 0 to 27 (higher score=greater levels of hostility)/ End point values adjusted for baseline values age and sex.|6 weeks|ITT, 1 subject excluded from analysis due to missing data.||units on a scale||95% Confidence Interval|Mean
754322|NCT00574847|Secondary|Perceived Stress Scale|Score range, 10 to 50 (higher score = greater levels of perceived stress). End point values adjusted for baseline values age and sex.|6 weeks|ITT||units on a scale||95% Confidence Interval|Mean
754323|NCT00574847|Secondary|Platelet Serotonin Binding Affinity Kd_100|End point values adjusted for baseline values age and sex.|6 weeks|ITT, 27 subjects were excluded from analysis due to missing data.||nM||95% Confidence Interval|Mean
754324|NCT00574847|Secondary|5HTT, Serotonin Transporter Protein|End point values adjusted for baseline values age and sex.|week 6|ITT, 29 subjects excluded from analysis due to missing data.||fmol/mg||95% Confidence Interval|Mean
754325|NCT00574847|Secondary|Mental Stress Induced Change in Heart Rate|"A standard 12-lead Electrocardiograph (ECG) will be recorded at 1-minute intervals during the last 3 minutes of each rest period, the 3 minutes of the mental stress testing, and during exercise testing. Heart rate will be determined from the ECGs.
Mental Stress Induced Change in heart rate will be calculated by taking the mean of the mental stress heart rate measurements minus the resting heart rate measurements. End point values adjusted for baseline values age and sex."|baseline, 6 weeks|ITT, 10 subjects excluded from analysis due to missing data.||beats/minute||95% Confidence Interval|Mean
754326|NCT00574847|Secondary|Beck Depression Inventory|The Beck Depression Inventory II (BDI-II) is a 21 question, self-administered measure of depressive symptoms. Score range, 0 to 63 (higher score=greater severity of depressive symptoms). End point values adjusted for baseline values age and sex.|6 week|ITT||units on a scale||95% Confidence Interval|Mean
754327|NCT00574847|Secondary|Percentage of Participants With Adverse Events||Baseline to week 6|||percentage of participants|||Number
754328|NCT00574847|Secondary|Mental Stress Induced Change of Diastolic Blood Pressure|Blood pressure will be measured the last 3 minutes of the 20 minute calibration period (resting), every minute during the 3 minutes mental stress testing, the last 3 minutes of the 6 minute rest periods between mental stress testing, and every minute during and after the physical stress testing with an automatic oscillometric blood pressure monitor (Quinton Electronics). Mental Stress Induced Change of Diastolic Blood Pressure will be calculated by taking the mean of the mental stress Diastolic blood pressure measurements minus the resting Diastolic blood pressure. End point values adjusted for baseline values age and sex.|Baseline, week 6|ITT, 9 subjects excluded from the analysis due to missing data.||mm Hg||95% Confidence Interval|Mean
754341|NCT00575016|Secondary|Change From Baseline in Maximum Cystometric Capacity (MCC)|Change from baseline in MCC at week 6. MCC represents the maximum volume of urine the bladder holds. A positive number change from baseline represents an improvement (increase) in maximum volume of urine the bladder holds.|Baseline, Week 6|Modified Intent-To-Treat: defined as all patients who were randomized (started study) and received treatment||Milliliters (mL) of urine||Standard Deviation|Mean
754329|NCT00574847|Secondary|Mental Stress Induced Change of Systolic Blood Pressure|Blood pressure will be measured the last 3 minutes of the 20 minute calibration period (resting), every minute during the 3 minutes mental stress testing, the last 3 minutes of the 6 minute rest periods between mental stress testing, and every minute during and after the physical stress testing with an automatic oscillometric blood pressure monitor (Quinton Electronics). Mental Stress Induced Change of Systolic Blood Pressure will be calculated by taking the mean of the mental stress systolic blood pressure measurements minus the resting Systolic blood pressure. End point values adjusted for baseline values age and sex.|Baseline, week 6|ITT, 9 subjects excluded from analysis due to missing data.||mm Hg||95% Confidence Interval|Mean
754330|NCT00574847|Primary|Percentage of Participants With an Absence of Mental Stress-induced Myocardial Ischemia (MSIMI) During the 3 Mental Stressors|MSIMI is defined by the following: compared to rest, 1) any development of new abnormal wall motion; 2) reduction of LVEF 8% and/or; 3) deviation (depression or elevation) of ST-segment of ECG in 2 or more leads lasting for 3 consecutive beats, occurring during at least one of the 3 mental stress tasks.|Week 6|Intent-to-treat (ITT)||percentage of participants||95% Confidence Interval|Number
754331|NCT00574873|Secondary|Cumulative Incidence of On-Treatment Transformation to Accelerated Phase (AP) or Blast Phase (BP) at 192 Weeks|"The cumulative incidence curve was generated based on the time from randomization to the first date of transformation to AP or BP while on study treatment adjusting for the competing risk of treatment discontinuation without transformation, for each participant.
Criteria for transformation to AP: 15 to 29% blasts; ≥30% blasts + promyelocytes; ≥20% basophils in blood or bone marrow; platelets <100*10^9/L (not related to therapy), in blood. Criteria for transformation to BP: ≥30% blasts in blood or bone marrow and extramedullary involvement other than liver or spleen (example: chloromas).
Time to transformation was calculated as weeks = ([date of first documented occurrence of the event - date of randomization] + 1)/7. If transformation was not obtained, censoring was at the last hematologic assessment or death (whichever was earliest). Participants who were not treated contributed time = 1 day/7. 95% confidence interval for the cumulative incidence is from Gray’s method."|192 weeks|ITT population||Percentage of Participants||95% Confidence Interval|Number
754332|NCT00574873|Secondary|Kaplan-Meier Estimate of Probability of Retaining Derived MMR at 144 Weeks|"The Kaplan-Meier curve was generated based on the first date of MMR until the first date loss of MMR, objectively documented, for responders only. Participants without confirmed loss of response were censored at the last valid molecular assessment.
Molecular response was assessed using Bcr-Abl transcript levels measured by RT-PCR from peripheral blood. MMR is defined as a ratio Bcr-Abl/Abl ≤0.1% on the international scale (≥3 log reduction from standardized baseline in ratio of Bcr-Abl to Abl transcripts) with at least 3000 Abl analyzed.
The medians have not been reached in either arm, as such, the premature estimated hazard ratio is provided. Three years rate was displayed since the majority of imatinib participants had first MMR by Year 2."|144 weeks|Subgroup of participants from ITT population who had MMR.||Percentage of Participants||95% Confidence Interval|Number
754333|NCT00574873|Secondary|Kaplan-Meier Estimate of Probability of Retaining Complete Hematologic Response (CHR) at 192 Weeks|"The Kaplan-Meier curve was generated based on the first date of confirmed CHR until the first date of loss of CHR, objectively documented, for responders only. Participants without confirmed loss of response were censored at the last valid hematologic assessment.
CHR must have been of at least 4 weeks in duration confirmed by 2 assessments at least 4 weeks apart and was defined as follows: white blood cells ≤ institutional upper limit of normal, no peripheral blasts or promyelocytes, myelocytes + metamyelocytes <5% in blood, absolute neutrophil count ≥1.0*10^9/L, platelets ≥100 but <450*10^9/L unless related to therapy, <20% basophils in blood and no extramedually involvement (including hepato- or splenomegaly).
The medians have not been reached in either arm, as such, the premature estimated hazard ratio is provided. Four years rate was displayed since the majority of participants had first CHR by Year 1."|192 weeks|Subgroup of participants from ITT population who had CHR.||Percentage of Participants||95% Confidence Interval|Number
754334|NCT00574873|Secondary|Kaplan-Meier Estimate of Probability of Retaining CCyR at 192 Weeks|"The Kaplan-Meier curve was generated based the time from the first date of CCyR until the first date of confirmed loss of CCyR, objectively documented, for responders only. Participants without confirmed loss of CCyR were censored at the last valid cytogenetic assessment.
CyR is based on the prevalence of Ph+ metaphases among cells in metaphase on a bone marrow sample. CCyR was achieved when there was 0% Ph+ metaphases among cells in a BM sample when at least 20 metaphases from a BM sample were analyzed, or <1% Bcr-Abl fusion product among cells in a BM sample or peripheral blood sample when at least 200 cells were analyzed.
The medians have not been reached in either arm, as such, the premature estimated hazard ratio is provided. Four years rate was displayed since the majority of participants had first CCyR by Year 1."|192 weeks|Subgroup of participants from ITT population who had CCyR.||Percentage of Participants||95% Confidence Interval|Number
754335|NCT00574873|Secondary|Percentage of Participants With Major Molecular Response (MMR) at Year 1|Molecular response was assessed using Bcr-Abl transcript levels measured by reverse transcriptase polymerase chain reaction (RT-PCR) from peripheral blood. A MMR was defined as a ratio Bcr-Abl/Abl less than or equal to (≤) 0.1% on the international scale (greater than or equal to [≥] 3 log reduction from standardized baseline in ratio of Bcr-Abl to Abl transcripts) with at least 3000 Abl analyzed.|Year 1 (48 weeks)|ITT Population||Percentage of Participants||95% Confidence Interval|Number
754336|NCT00574873|Primary|Percentage of Participants With Complete Cytogenetic Response (CCyR) at Year 1|Cytogenetic Response (CyR) is based on the prevalence of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase on a bone marrow (BM) aspirate. CCyR was achieved when there was 0 percent (%) Ph+ metaphases among cells in a BM sample when at least 20 metaphases from a BM sample were analyzed, or less than (<) 1% breakpoint cluster region Abelson protooncogene (Bcr-Abl) fusion product among cells in a BM sample or peripheral blood sample when at least 200 cells were analyzed.|Year 1 (48 weeks)|Intent-to-treat (ITT) population - included all participants who were randomized to test article.||Percentage of Participants||95% Confidence Interval|Number
754337|NCT00574912|Primary|Maximum Glucose Infusion Rate|measuring the changes in glucose infusion rate during the 24 hour experimental period.|24 hours|12 participants in each arm||umol/kg/min||Standard Error|Mean
754391|NCT00581386|Primary|Duration of Intubation|The time taken to successfully place the device in seconds.|duration of intubation|||seconds||Standard Deviation|Mean
779133|NCT00787267|Secondary|Determine Relationship Between K-ras Gene Mutation and Response to Dasatinib.||2 years|Assays were not run because no objective tumor response was observed.|||||
754342|NCT00575016|Primary|Change From Baseline in Number of Weekly Episodes of Urinary Incontinence|Change from baseline in the weekly frequency of incontinence episodes at Week 6 after the first treatment. Incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).|Baseline, Week 6|Modified Intent-To-Treat: defined as all patients who were randomized (started study) and received treatment||Number of Weekly Episodes||Standard Deviation|Mean
754343|NCT00575029|Primary|Time Required for Recovery From Adrenal Suppression to Normal Adrenal Function|the number of weeks required for participants to recover from adrenal suppression as assessed by a normal ACTH stimulation test (cortisol level >21 mcg/dl)|weekly for up to 6 weeks|||weeks|||Number
754344|NCT00575029|Primary|Number of Participants With Adrenal Insufficiency|Number of participants with adrenal insufficiency after treatment with megestrol acetate assessed by ACTH stimulated cortisol levels less than normal (21 ug/dl) measured weekly for 8 weeks or when adrenal insufficiency is clinically encountered|stimulated acth stimulated cortisol levels weekly for 8 weeks or until adrenal insufficiency is encountered|||participants|||Number
754347|NCT00575094|Primary|Number of Patients by Clinical Response at Test-of-Cure (TOC) Visit.|Clinical response: Cure=all initial signs/symptoms of pneumonia (SSx) improved; chest x-ray (CXR)improved/stable; no other antibiotics for pneumonia; no worsening or new SSx. Failure=persistence or worsening SSx; no clinical improvement or initial improvement with clinically important worsening; other antimicrobials for pneumonia CXR progression; death > study day 2 due to pneumonia. Indeterminate=unable to determine outcome for nonstudy drug/infection reasons (eg, lost to follow-up); death ≤2 days after first dose for any reason, or >2 days but before TOC visit for non-pneumonia reason.|8 weeks|All patients who received at least one dose of study drug.||participants|||Number
754348|NCT00575146|Secondary|Quality of Life||while on study treatment for up to 12 months||||||
754349|NCT00575146|Secondary|Ketosis||while on study treatment for up to 12 months||||||
754350|NCT00575146|Secondary|Frequency of Seizures||while on study treatment for up to 12 months||||||
754351|NCT00575146|Secondary|Overall Survival|Participants were followed until reported death or last contact until 05/2011|death/last contact, an average of about 1 year|||weeks||Full Range|Median
754352|NCT00575146|Secondary|Progression-free-survival|measured by Macdonald-Criteria|until progression for up to 12 months|for the analyis of PFS and OS, 3 patients who discontinued the diet in the absence of progression were excluded||weeks||Full Range|Median
754353|NCT00575146|Primary|Applicability as Measured by Discontinuation of Study Treatment Due to Intolerability|percentage of patients who discontinued diet due to intolerability|until progression for up to 12 months|||percent of participants|||Number
755319|NCT00593606|Primary|Change in Percentage of Neutrophilic Granulocytes Segmented in White Blood Cell Count|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||Percentage of white blood cell count||Standard Deviation|Mean
754377|NCT00575185|Secondary|Number of Participants Who Experienced Adverse Events During the Study Safety and Tolerability|Assessing adverse events in participants to see if this drug causes more or less side effects|15 days|||participants|||Number
754378|NCT00575185|Primary|Number of Participants With Improvement in Clinical Symptoms and Reductions in Viral Burden From Baseline|All subjects had confirmed cases of EB and will be assessed for Improvement of clinical symptoms (ie: tiredness, nausea etc)and reduction in viral burden from baseline|21 days|||participants|||Number
754379|NCT00581347|Secondary|Receipt of a Well Child Visit Within a 12 Month Period|We compared the number of participants in the intervention group who received a well child visit within a 12 month period versus those in the control group.|1 year|||participants|||Number
754380|NCT00581347|Primary|Receipt of Adolescent Immunization at End of Study Period (Tdap, Menactra, HPV)|We compared the number of participants in the intervention group who received vaccinations for Tdap, Menactra, and (for girls only) HPV at the end of the study period versus those in the control group.|15 months|||participants|||Number
754381|NCT00581360|Secondary|Median Duration of Stable Disease Response|Median number of months of Stable Disease Response Per RECIST v1.0 (Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started)|Up to 36 months|||months||Full Range|Median
754382|NCT00581360|Secondary|Number of Months of Survival|Number of months that the participant was alive.|Up to 5 years|||months|||Number
754383|NCT00581360|Secondary|Number of Months of Progression-free Survival (PFS)|Number of months that participants experienced stable disease (the disease does not progress per RECIST v1.0 criteria - Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started)|Up to 5 years|||months|||Number
754384|NCT00581360|Primary|Stable Disease Rate|Using RECIST v1.0 criteria, stable disease rate is the number participants experiencing stable disease (SD) / the number participants experiencing partial response (PR) + the number participants experiencing complete response (CR) + the number participants experiencing stable disease (SD) + the number participants experiencing progressive disease (PD).|Up to 5 years|All patients in this population had stable disease as best response.||percentage of participants|||Number
754385|NCT00581360|Primary|Objective Response Rate (ORR)|ORR is the number participants experiencing partial response (PR) + the number participants experiencing complete response (CR) / the number participants experiencing partial response (PR) + the number participants experiencing complete response (CR) + the number participants experiencing stable disease (SD) + the number participants experiencing progressive disease (PD). RECIST v1.0 criteria for Target Lesions was used: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest s|Up to 5 years|||percentage of participants|||Number
754386|NCT00581386|Primary|Number of Failed Cases|We calculated the number of failed cases. As per protocol, that is number of patients in whom successful intubation was not achieved with the assigned device after 3 attempts.|Time taken for successful intubation|As per protocol, a case is decided as a failed case when the patient was not able to be intubated with the assigned device after 3 attempts.||Participants|||Number
754387|NCT00581386|Primary|Post Operative Morbidity|We followed the patients 2 and 24 hours after the surgery for sore throat, hoarseness and dysphagia.The numbers represented here are the number of patients who reported sore throat at 2 hrs and after 24 hrs as per the protocol.|2 hrs and 24 hrs after surgery|As per protocol,all the patients were followed up at 2 hrs and 24hrs to check for any postoperative hoarseness, sorethroat and difficulty swallowing. The numbers represent the number of patients who complained of postoperative morbidity.||participants|||Number
754388|NCT00581386|Primary|Leak Pressures|The maximum leak pressure attained for each device.|Duration of surgery|||cm of H2O||Standard Deviation|Mean
754389|NCT00581386|Primary|Number of Patients Who Required Multiple Attempts.|The number of repeated attempts required for successfully placing the device. Each device was given a chance of 3 attempts if still unsuccessful after 3 attempts another device was placed.|Time taken for intubation|As per protocol,the number of cases in whom the device could not be placed successfully in first attempt and required 2nd and 3rd attempts.||Participants|||Number
754390|NCT00581386|Primary|Number of Participants With a Successful First Attempt Placement|The number of patients in whom the assigned device was successfully placed in the first attempt as per protocol.|Time taken for successful placement|As per protocol,of all the patients intubated with the assigned specific device number of patients in whom the device was placed successfully in the first attempt.||Participants|||Number
754398|NCT00581542|Secondary|Number of Participants With a Negative Bacterial Culture|Conjunctival swab specimens were inoculated onto tryptic soy agar with 5% sheep blood and GC II agar supplemented with hemoglobin and isovialex with incubation at 35 degrees C in ambient air supplemented with 5% carbon dioxide for 48 hours. S pneumoniae, H influenzai and M Catarrhalis were identified.|10 days|Only participants who were culture positive at baseline were tested at day 10. 20 participants were negative at baseline in the polytrim group and 11 participants were negative in the moxifloxin group.||participants|||Number
754399|NCT00581542|Primary|Number of Participants With Normal Physical Examination of the Eye||10 days|||participants|||Number
754400|NCT00581555|Secondary|Percentage of Rebound Effects|Rebound effects was defined as worsening of psoriasis to 125% of the baseline PASI or appearance of psoriasis variants such as erythrodermic or pustular psoriasis within 12 weeks of discontinuation of therapy.|Baseline to Week 24.|ITT population: included all randomized participants.n equals number of participants with evaluable data for this outcome measure.||percentage of participants|||Number
754401|NCT00581555|Secondary|DLQI at Each Visit From Baseline|DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10 item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst).|Baseline to Week 24.|ITT population: included all randomized participants. n equals number of participants with evaluable data||scores on a scale||Standard Error|Mean
754402|NCT00581555|Secondary|Change From Randomization in DLQI to Week 24|DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst).|Randomization to Week 24.|ITT population: included all randomized participants. n equals number of participants with evaluable data for this outcome measure.||scores on a scale||95% Confidence Interval|Mean
754403|NCT00581555|Secondary|Percent (%) Change of PASI Score From Randomization to Week 24|Percent improvement in PASI score was calculated from Week 6 to Week 24.|Randomization to Week 24.|ITT population: included all randomized participants. n equals number of participants with evaluable data for this outcome measure.||percent change||95% Confidence Interval|Mean
754404|NCT00581555|Primary|Change From Randomization in PASI Score to Week 24 (Week 18 of Etanercept Monotherapy/Placebo)|PASI score: range: 0 (none) to 72 (maximum). Body was divided into head, upper extremities, trunk and lower extremities; each area score was combined for final PASI. For each section, percent area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: (erythema, induration, and desquamation); scale: 0 (none) to 4 (maximum). Final PASI= sum of severity parameters for each section times area score times weight of section (head: 0.1, upper extremities: 0.2, trunk: 0.3, lower extremities: 0.4). Change = PASI at Week 24 - PASI at baseline.|Randomization to Week 24.|Intent-To-Treat (ITT) population: included all randomized participants. n equals number of participants with evaluable data for this outcome measure.||scores on a scale||95% Confidence Interval|Mean
754405|NCT00581555|Secondary|Probability of Being Relapse Free During the 24 Weeks After Randomization|Relapse was defined as loss of 50% improvement in PASI. The time to relapse was estimated using a Kaplan-Meier analysis.|Randomization to Week 24.|ITT population: included all randomized participants. n equals number of participants with evaluable data for this outcome measure.||probability of relapse free|||Number
754406|NCT00581555|Secondary|Relapse (Loss of 50% Improvement in PASI) During the 24 Weeks After Randomization|Relapse was defined as the loss of 50% improvement in PASI.|Randomization to Week 24.|ITT population: that included all randomized participants. n equals number of participants with evaluable data for this outcome measure.||Percentage of participants|||Number
754407|NCT00581555|Secondary|Change From Randomization in PGA Score to Week 24|PGA score is based on dermatologist's assessment of disease averaged over all lesions. Overall lesions were graded for individual scores of induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Change = PGA at Week 24 - PGA at baseline.|Randomization to Week 24.|ITT population: included all randomized participants. n equals number of participants with evaluable data for this outcome measure.||scores on a scale||95% Confidence Interval|Mean
754409|NCT00581581|Primary|WeeFIM Score|WeeFIM instrument (the Functional Independence Measure for Children, Uniform Data System for Medical Rehabilitation, Buffalo, NY) is a set of ratings of 18 skills divided into 3 general domains: 8 Self-care; 5 Mobility; 5 Cognition. Caregivers rate a child about extent of independence, full functioning, in carrying out each of those 18 skills, on a scale from “1” for total assistance, total dependence, maximal prompting, or not testable to “7” for complete independence. The ratings are combined to yield 3 Domain scores and a WeeFIM Total. Favorable=mean+/-2SD. We are reporting the percentage of participants with a favorable response.|7-8 years after initial intervention|||percentage of participants|||Number
754410|NCT00582660|Primary|Subjects With Positive Response 72 Hours After Administration of Study Treatment as Measured by Immunoblot|At 72 hours after start of treatment, the number of subjects with immunoblot demonstrated a 1.5 to 2 fold increase in 15-LOX-1 protein expression in human colorectal adenocarcinoma cell line with epithelial morphology(HT-29) and dihydrolipoamide dehydrogenase(DLD)-1 cells.|baseline to 72 hours|||Participants|||Number
754411|NCT00582660|Primary|Number of Subjects Witha Change (IMPROVEMENT) in Colo-rectal Adenocarcinoma as Measured by Cyclooxygenase-2 Activity After 7 Days of Celecoxib|"The Colo-Rectal adenocarcinoma will be measured by cyclooxygenase-2(COX-2) activity at 7 days post baseline. Cox-2 activity is measured by assessing tumors and normal tissue using Electron microscope and Tandem mass Spectrometry methodology though the UAB shared Mass Spectrometry facility. Improvement was measured by 2-fold increase in COX-2 activity from baseline. The methodology used was High Performance Liquid Chromatography(HPLC). additional studies include expression of genes thought to be important in colorectal carcinogenesis: COX-1 and 2, MMP, 2 7, and 9, tissue inhibitor of metalloproteinases(TIMPs) 1 ans 2 and beta-catenin."|baseline to 7 days|||Participant|||Number
754412|NCT00582712|Primary|Tumor Response Rate Measured by the Response Evaluation Criteria in Solid Tumors (RECIST)||1 year|No data was ever analyzed, resulted, or published on this study.|||||
754413|NCT00582738|Secondary|Change From Baseline in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Viral Load at 12 and 24 Months Post Randomization|End of Study (EOS) endpoint is the last available assessment on or after Month 12. A reduction of at least two logs in HCV RNA viral load was considered as success|baseline, 12 months, 24 months/EOS|The Intent to Treat (ITT) population consists of all patients randomized and who have at least one dose of study medication. If 12-month HCV was the last available assessment, this value is used to impute the End of Study value.||log10 copies/ml||Standard Deviation|Mean
754414|NCT00582738|Secondary|Percentage of Patients in Each Study Arm With Increase of ≥1 Point in the Ishak-Knodell Staging Score in Fibrosis|Ishak-Knodell Score: 0=No fibrosis; 01=Fibrous expansion of some portal areas, with or without short fibrous septa; 02=Fibrous expansion of most portal areas, with or without short fibrous septa; 03=Fibrous expansion of most portal areas, with occasional portal to portal (P-P) bridging; 04=Fibrous expansion of portal areas, with marked bridging (portal to portal (P-P) as well as portal to central (P-C)); 05=Marked bridging (P-P and/or P-C) with occasional nodules (incomplete cirrhosis); 06=Cirrhosis, probable or definite.|baseline to month 24|Difference Ishak-Knodell Score at End-of-Study The Intent to Treat (ITT) population consists of all patients randomized and who have at least one dose of study medication||percentage of participants|||Number
754415|NCT00582738|Secondary|Comparison of the Effect of Both Regimens on the Inflammatory (Acti-test) and Fibrosis (Fibro-test) Components of Fibrosure, and on Fibrosis Area Assessed by Histomorphometry|"The Fibrosure test is the combination of Fibro-test + Acti-test.
FibroTest (FT) was for the assessment of fibrosis. Fibro test was calculated using an original combination of five highly concentrated serum biochemical markers; alpha2macroglobulin, haptoglobin, apolipoprotein A1, total bilirubin and gammaglutamyltransferase (GGT). FibroTest scores range from 0.00 to 1.00 where 0.0-0.21 is no fibrosis and >= 0.59 is cirrhosis.
Acti-test was calculated using 6 serum biochemical markers; alpha2macroglobulin, haptoglobin, apolipoprotein A1, total bilirubin, GGT and alanine aminotransferase (ALT). ActiTest (AT) was used for the assessment of necroinflammatory activity. Test score ranges from 0.00 to 1.00, where 0.00-0.17 indicates no necrosis and >= 0.61 indicates severe necrosis
If 12-month Actitest value was the last available assessment, the value is used to impute the final staging score(End of Study)"|baseline, 12 and 24 months|The Intent to Treat (ITT) population consists of all patients randomized and who have at least one dose of study medication. During different time points, participants with observations at that time point were included in the analysis.||units on a scale||Full Range|Median
754416|NCT00582738|Secondary|Comparison of the Effect of Both Regimens in the Necroinflammatory Grading Score (Ishak-Knodell) (Portal Inflammation)|Ishak-Knodell Score: 0=No fibrosis; 01=Fibrous expansion of some portal areas, with or without short fibrous septa; 02=Fibrous expansion of most portal areas, with or without short fibrous septa; 03=Fibrous expansion of most portal areas, with occasional portal to portal (P-P) bridging; 04=Fibrous expansion of portal areas, with marked bridging (portal to portal (P-P) as well as portal to central (P-C)); 05=Marked bridging (P-P and/or P-C) with occasional nodules (incomplete cirrhosis); 06=Cirrhosis, probable or definite|baseline, 12 months, 24 months|The Intent to Treat (ITT) population consists of all patients randomized and who have at least one dose of study medication. During different time points, participants with observations at that time point were included in the analysis.||Score on a scale||Standard Deviation|Mean
754417|NCT00582738|Secondary|Comparison of Renal Function (Glomerular Filtration Rate [GFR] Calculated Using the Modification of Diet in Renal Disease Study Group [MDRD] Formula) Between Study Groups|"GFR Month 9 value if available, otherwise minimal first year post-randomization available value. Imputation rule of missing Month 24 GFR values: GFR Month 18 value if available, otherwise Month 12 GFR is used.
Least square means are from an ANCOVA model containing treatment as factor and baseline eGFR as a covariate."|12 months, 24 months/EOS|The Intent to Treat (ITT) population consists of all patients randomized and who have at least one dose of study medication. During different time points, participants with observations at that time point were included in the analysis.||mL/min/1.73^2||Standard Error|Least Squares Mean
754418|NCT00582738|Secondary|Number of Patients With Events (Progression to Cirrhosis, Retransplantation, HCV Related Death, First BPAR, Graft Loss)at 12 and 24 Months||12 months, 24 months|The Intent to Treat (ITT) population consisted of all patients randomized and who had at least one dose of study medication. During different time points, participants with observations at that time point were included in the analysis.||participants|||Number
755320|NCT00593606|Primary|Change in Percentage of Monocytes in White Blood Cell Count|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||Percentage of white blood cell count||Standard Deviation|Mean
754420|NCT00582738|Secondary|Change From Baseline in Fibrosis Metavir Scoring at 12 and 24 Months Post Randomization|Metavir Score: F0=No fibrosis; F1=Portal fibrosis without septa; F2=Portal fibrosis with rare septa; F3=Numerous septa without cirrhosis Decrease in score from baseline indicates improvement|Baseline, 12 months, 24 months|The Intent to Treat (ITT) population consisted of all patients randomized and who had at least one dose of study medication. Only participants with observations at baseline and specified timepoints were included in the analysis.||Scores on a Scale||Full Range|Median
754421|NCT00582738|Primary|Change From Baseline in Fibrosis Staging Score (Measured by the Ishak-Knodell Staging Score) Between Baseline and 24 Months Post-transplant.|"Ishak-Knodell Score: 0=No fibrosis; 01=Fibrous expansion of some portal areas, with or without short fibrous septa; 02=Fibrous expansion of most portal areas, with or without short fibrous septa; 03=Fibrous expansion of most portal areas, with occasional portal to portal (P-P) bridging; 04=Fibrous expansion of portal areas, with marked bridging (portal to portal (P-P) as well as portal to central (P-C)); 05=Marked bridging (P-P and/or P-C) with occasional nodules (incomplete cirrhosis); 06=Cirrhosis, probable or definite
Decrease in score from baseline indicates improvement"|baseline, 24 Months|The Intent to Treat (ITT) population consisted of all patients randomized and who had at least one dose of study medication. Small number of biopsies obtained at Month 24 due to study being prematurely terminated.||Score on Scale||Full Range|Median
754426|NCT00582816|Secondary|Analysis of NK Cell KIR Expression Over Time|NK cell KIR expression over time will be examined. Blood samples will be collected at months 1, 2, 3, 6, 9, and 12.|Up to 12 months|Blood samples were not collected uniformly as many patients developed GVHD, requiring treatment with steroids. Once steroids were initiated the results of this testing became uninterpretable. No data was collected towards this outcome measure.|||||
754427|NCT00582816|Secondary|Association Between Parental KIR Genotypes and NK Cell Cytotoxicities|NK cells express killer-cell immunoglobulin-like receptors (KIR) and have cytotoxic activity. The association between NK cell cytotoxicity over time and KIR genotypes will be examined. Blood samples will be collected at months 1, 2, 3, 6, 9, and 12.|Day 60|Blood samples were not collected uniformly as many patients developed GVHD, requiring treatment with steroids. Once steroids were initiated the results of this testing became uninterpretable. No data was collected towards this outcome measure.|||||
754428|NCT00582816|Secondary|NK Expression Levels|Natural Killer (NK) cell expression levels will be explored. Blood samples will be collected at months 1, 2, 3, 6, 9, and 12.|Up to 12 months|Blood samples were not collected uniformly as many patients developed GVHD, requiring treatment with steroids. Once steroids were initiated the results of this testing became uninterpretable. No data was collected towards this outcome measure.|||||
754429|NCT00582816|Primary|Mortality Rate|Mortality rate at 100 days post-transplant.|100 days post-transplant|Death Prior to Day +100||participants|||Number
754430|NCT00582816|Primary|Number of Days Until Engraftment Criteria Were Met|"Utilize non-myeloablative conditioning regimen in the haploidentical transplant setting. Engraftment is defined as achieving an absolute neutrophil count ≥ 500 by 28 days post-transplant; platelets and red blood cells will also be measured up to 28 days:
Neutrophils: ≥500/uL for 3 days
Platelets: ≥20 K/uL for 3 days without transfusion
Red blood cells: the date of the last RBC transfusion after achieving transfusion independence Results are reported as number of days until engraftment criteria was met, per neutrophil, platelet and red blood cell measurements, above."|28 days|||days||Full Range|Median
754431|NCT00582816|Primary|Engraftment Failure|"Utilize non-myeloablative conditioning regimen in the haploidentical transplant setting.
Primary engraftment failure: failure to achieve ANC of ≥500/uL prior to day +28 Late engraftment failure: Initial engraftment achieved with ANC ≥500/uL by day +28 followed by loss of graft Autologous Cells Infused: achieved hematologic recovery following infusions of autologous stem cells Second Haploidentical Transplant: re-transplantation utilizing an alternative haploidentical donor"|28 days|||participants|||Number
754550|NCT00584194|Secondary|Immunogenicity: Geometric Mean Titers After 3rd Vaccination|Measurement is the 80% plaque-reduction neutralization titer (PRNT80) antibodies to RVF virus following 3rd vaccination (Parts A and B of study)|28 days after dose 3|Population is based on responders (defined as a subject achieving a PRNT80 >1:40)||Titers||95% Confidence Interval|Geometric Mean
754432|NCT00582816|Primary|Grade III or IV GVHD|"Skin Grade III: Stage 0-4 GVHD, where 0 is no rash and 4 is generalized erythroderma with bullous formation and/or with desquamation Grade IV: Stage 4 GVHD, generalized erythroderma with bullous formation and/or with desquamation
GI (diarrhea) Grade III: Stage 2-4 GVHD, where 2 is > 1000 mL/day but ≤ 1500 mL/day or 556-833 mL/m2, and 4 is severe abdominal pain +/- ileus or stool with frank blood or melena Grade IV: Stage 0-4 GVHD, where 0 is < 500 mL/day or 280 mL/m2, and 4 is severe abdominal pain +/- ileus or stool with frank blood or melena
Overall:
Grade III: Grade III Skin and/or GI as well as bilirubin 3.1-15 mg/dl Grade IV: Grade IV Skin and/or GI as well as bilirubin > 15 mg/dl"|Day 100|||participants|||Number
754433|NCT00582894|Secondary|Number of Participants Overall Survival as a Function of Time.||100 days post transplant|Last observation carried forward||Participants|||Number
754434|NCT00582894|Primary|Number of Participants Experiencing Engraftment Donor Chimerism (EDC)||At time of study termination|||Participants|||Number
754435|NCT00582894|Secondary|Number of Participants Relapse-Free||100 days post-transplant|Last observation carried forward||Participants|||Number
754436|NCT00582894|Primary|Number of Participants Experiencing Transplant Related Mortality (TRM)||At Day 100 post trans-plant|||Participants|||Number
754437|NCT00582907|Secondary|To Determine the Differences in the Proportion of Time Subjects Received Rilonacept vs Placebo|"The proportion of time within the trial that participants received rilonacept as opposed to placebo. The reason for this outcome is that participants who had at least 2 attacks within an individual treatment course were able to escape in a blinded manner to the other treatment arm until the end of that treatment course and then resume the original randomization sequence. Thus participants may have been treated for a longer time with one treatment arm or the other."|12 months|Participants who received at least one treatment course of both rilonacept and placebo.||Percentage of time treated||95% Confidence Interval|Number
754438|NCT00582907|Secondary|To Determine the Differences in the FMF Severity Score of the Subjects Between the Treatment Arms (Rilonacept vs. Placebo).|Differences in the Armenian Evaluation Score between rilonacept and placebo courses. The Armenian Evaluation Score is a composite score of disease severity based on the frequency, duration and character of attacks (degree of fever and severity of serositis). It was adapted to calculate a score for a 3-month treatment course. The lowest (best) score is 0 and higher values are worse. In theory there is no upper limit to the scale. The total score is reported (there are no subscales).|overall 12 months|Participants who received at least one course each of placebo and rilonacept.||units on a scale||Inter-Quartile Range|Median
754439|NCT00582907|Secondary|To Determine the Differences in the Quality of Life Between the Treatment Arms (Rilonacept vs. Placebo).|Differences in the health-related quality of life (HRQOL) during treatment with rilonacept vs. placebo. HRQOl was measured by the Childhood Health Questionnaire which was adopted also for adults. There are 2 summary scores: 1. Physical summary score. 2. Psychosocial summary score. The data reported below in the upper table is the physical summary composite score and in the lower table the psychosocial summary composite score. Scores were from 0-100 (higher is better) with a score of 50 representing the mean of the normal population.|12 months|Participants who received at least one treatment course of rilonacept and placebo.||Composite HRQOL summary score||Inter-Quartile Range|Median
754440|NCT00582907|Secondary|To Determine the Differences in Serum Amyloid A Levels Between the Treatment Arms (Rilonacept vs. Placebo)|The difference between the treatment arms in serum amyloid A levels (mg/L)|3 months (each treatment course, overall 12 months)|Patients who received at least one course each of rilonacept and placebo||mg/L||Inter-Quartile Range|Median
754441|NCT00582907|Secondary|To Determine the Differences in the Fibrinogen Levels Between the Treatment Arms (Rilonacept vs. Placebo)|The differences between treatment arms in the fibrinogen level (micromol/L)|3 months (each treatment course, overall 12 months)|Patients who received at least one course each of rilonacept and placebo||micromol/L||Inter-Quartile Range|Median
754442|NCT00582907|Secondary|To Determine the Differences in the Platelet Count Between the Treatment Arms (Rilonacept vs. Placebo)|The difference between the treatment arms in the platelet count X 10 to the power of 9|3 months (each treatment course, overall 12 months)|The number of patients who received at least one course each of rilonacept and placebo||cell count X10 to the power of 9||Inter-Quartile Range|Median
754443|NCT00582907|Secondary|To Determine the Differences in C-Reactive Protein Between the Treatment Arms (Rilonacept vs. Placebo)|Differences between the treatment courses in the C-Reactive Protein levels mg/L|3 months (each treatment course, overall 12 months)|Patients who received at least one course each of rilonacept and placebo||mg/L||Inter-Quartile Range|Median
754444|NCT00582907|Secondary|To Determine the Differences in the Erythrocyte Sedimentation Rate Between the Treatment Arms (Rilonacept vs. Placebo).|Erythrocyte sedimentation rate - ESR (mm/h)|3 months (each treatment course, overall 12 months)|Participants who completed at least one treatment course of both rilonacept and placebo.||mm/h||Inter-Quartile Range|Median
754445|NCT00582907|Secondary|To Determine Differences in the Time to the Development of Attacks Between the Treatment Arms (Rilonacept vs. Placebo).|In a survival analysis we measured the difference (in days) until the development of the first and second attack within a treatment course of up to 3 months and examined differences in this parameter between rilonacept and placebo. Data regarding the development of the second attack are reported below. In regards to the first attack there were no significant differences between rilonacept and placebo (20 days (7.5,>90)for rilonacept; 15 (8,32) for placebo, P=0.066).|3 months|All participants who received an intervention and developed an attack were analyzed.||days until second attack||Inter-Quartile Range|Median
754446|NCT00582907|Secondary|To Determine the Proportion of Courses in Which Subjects Attained at Least a 50% Decrease in Acute FMF Attacks During Rilonacept Courses as Compared to Placebo Courses.|Differences between rilonacept and placebo in the percentage of courses that attained at least a 50% decrease in FMF attacks when compared to attacks in the screening period.|Up to 3 months for each treatment course|Participants who completed at least one complete treatment course.||Percentage of courses|||Number
754447|NCT00582907|Secondary|Percentage of Treatment Courses Without FMF Attacks in Rilonacept Courses as Compared to Placebo Courses.|The percentage of rilonacept and placebo treatment courses without FMF attacks.|Each treatment course of up to 3 months|Participants who at least one complete treatment course.||Percentage of courses|||Number
754551|NCT00584194|Primary|Safety: All Incidences of Erythema|Collect data on the occurrence of AEs and SAEs in reference to Erythema (most frequently reported AE) in parts A and B of the study|12 months|||number of events|||Number
754449|NCT00582907|Primary|To Determine if There is a Medically Important Difference Between the Safety Profiles of Rilonacept vs. Placebo.|Differences in adverse events (AEs) between rilonacept and placebo per patient-month of treatment. We separately analyzed injection site reactions and infectious adverse events. Other adverse events were too small in number to analyze. The upper table (and first statistical analysis) regards injection site reactions and lower table (and second statistical analysis) regards infections.|12 months of entire study length|Safety analysis included all participants who received at least one dose of medication.||AEs per patient-month of treatment||Inter-Quartile Range|Median
754450|NCT00582907|Primary|To Assess the Efficacy of Rilonacept in Decreasing the Number of Acute FMF Attacks.|Difference in number of attacks per treatment month between rilonacept and placebo|attacks were assessed at the end of each 3 month treatment course (overall up to 6 month of rilonacept and 6 months of placebo, each)|Patients who received at least one complete treatment course and reported attacks were analyzed for the primary outcome measure.||number of attacks per month||Inter-Quartile Range|Median
754451|NCT00582933|Primary|Death From GVHD|To establish the early transplant-related severe morbidity and mortality and 3-the incidence and severity of GvHD.|2 years|||participants|||Number
754452|NCT00582946|Primary|Maximum Effective Sound Pressure Level (MEPO)|A primary outcome measure of interest is an estimate of the insitu maximum equivalent pressure output (MEPO) of the EarLens system, which represents the sound pressure level that would have to be applied at the eardrum (or tympanic membrane) to produce the same degree of tympanic membrane (TM) vibration that the EarLens system produces with the coil current set to its maximum value, and given the anatomical constraints on the coupling between the coil and magnet for a given subject. The target fitting range included hearing loss up to 60 decibels (dB) Hearing Level (HL). In order for the device to be an effective hearing aid for this target population, the maximum output of the device needs to be able to provide output and gain to treat this maximum hearing loss.|1 month|||decibels (dB) Sound Pressure Level (SPL)||Standard Deviation|Mean
754453|NCT00582972|Secondary|Change in Bone Resorption From Baseline to 1 Month|urine n-telopeptide (normalized to creatinine levels)|change in bone resorption from baseline to 1 month|23 enrolled but two dropped from the study, leading to 21 subjects who completed all study visits||mcg/mmol creatinine||Standard Deviation|Mean
754454|NCT00582972|Primary|Change in Intestinal Calcium Absorption From Baseline to One Month|percent calcium absorption|change in calcium absorption from baseline to 1 month|Subjects completing the measures of calcium absorption were included in the analysis of the primary outcome.||percent calcium absorption||Standard Deviation|Mean
754455|NCT00583115|Secondary|1) Decrease in Pulmonary Artery Pressures and Vascular Resistance as Determined by Cardiac Catheterization, 2) Time to Clinical Worsening,3) Survival.||6 months|The only participant died prior to study completion. Unable to measure pulmonary artery pressure and vascular resistance as only participant died prior to study completion. Unable to measure time to clinical worsening as only participant died. Survival should be counted as 0.|||||
754456|NCT00583115|Primary|1) Safety and Tolerability as Determined by Laboratory Evaluation, Physical Examination, Echocardiographic Analysis, and Adverse Events, and 2) Efficacy as Determined by an Increase in the Non-encouraged 6 Minute Walk Test From Baseline.||6 months|Unable to measure safety and tolerability as the participant died prior to study completion. Laboratory evaluations not able to be measured as participant died. Physical examination, Echocardiographic and adverse events not able to be measured as participant died Unable to measure 6 minute walk test as participant died prior to study completion.|||||
754457|NCT00583219|Secondary|Incontinence Impact Questionnaire-short Form (IIQ-7) Scores|The IIQ-7 was one measure of urinary-associated quality of life. The IIQ-7 questionnaire has 7 items, scored from 0 (not at all) to 3 (greatly), with total scores ranging from 0 to 21, a higher score indicating greater distress.|baseline, 1 month, 3 months|||units on a scale||Inter-Quartile Range|Median
754458|NCT00583219|Secondary|Bothersomeness|The bothersomeness refers to the question: On a scale of 1-10 (0 is not at all; 10 is intolerable), how badly does loss of urinary control bother you?|baseline, 1 month, 3 months|||units on a scale||Inter-Quartile Range|Median
754459|NCT00583219|Secondary|Median Urogenital Distress Inventory (UDI-6) Scores|The UDI-6 was one measure of urinary-associated quality of life. The UDI-6 questionnaire has 6 items, scored from 0 (not at all) to 3 (greatly), with total scores ranging from 0 to 18, a higher score indicating greater distress.|baseline, 1 month, 3 months|||units on a scale||Inter-Quartile Range|Median
754460|NCT00583219|Secondary|Urinary Urgency at 3 Months|Urinary urgency was measured by the Indevus Urgency Severity Scale (IUSS). The IUSS asks patients to assess the severity of ‘urgency’ at each void. The scale employs the following wording: “Degree of urgency is meant to describe your urge to urinate. Sometimes you may feel a very strong urge to urinate and at other times, you may feel a milder urge prior to the onset of a toilet void. Rate this feeling by circling 0, 1, 2, or 3, defined as: 0: NONE – no urgency, 1: MILD – awareness of urgency, but it is easily tolerated and you can continue with your usual activity or tasks, 2: MODERATE – enough urgency discomfort that it interferes with or shortens your usual activity or tasks, 3: SEVERE – extreme urgency discomfort that abruptly stops all activity or tasks.”|3 months after treatment|||participants (per category)|||Number
754461|NCT00583219|Secondary|Urinary Urgency at 1 Month|Urinary urgency was measured by the Indevus Urgency Severity Scale (IUSS). The IUSS asks patients to assess the severity of ‘urgency’ at each void. The scale employs the following wording: “Degree of urgency is meant to describe your urge to urinate. Sometimes you may feel a very strong urge to urinate and at other times, you may feel a milder urge prior to the onset of a toilet void. Rate this feeling by circling 0, 1, 2, or 3, defined as: 0: NONE – no urgency, 1: MILD – awareness of urgency, but it is easily tolerated and you can continue with your usual activity or tasks, 2: MODERATE – enough urgency discomfort that it interferes with or shortens your usual activity or tasks, 3: SEVERE – extreme urgency discomfort that abruptly stops all activity or tasks.”|1 month after treatment|||participants (per category)|||Number
754552|NCT00584220|Primary|Subject Reported Lens Comfort.|A weighted combined score of one week and two week data calculated from individual comfort-related questions asked on a 1-5 scale, 1=most negative response to 5=most positive response, was used to derive comfort outcomes. The analysis shows the estimates for senofilcon A and alphafilcon A, respectively. Interpretation is >0 indicates comfortable and <0 indicates uncomfortable.|1 week|Analysis includes only participants who completed the study per protocol and had no missing data.||Units on a scale||Standard Deviation|Least Squares Mean
754462|NCT00583219|Secondary|Urinary Urgency at Baseline|Urinary urgency was measured by the Indevus Urgency Severity Scale (IUSS). The IUSS asks patients to assess the severity of ‘urgency’ at each void. The scale employs the following wording: “Degree of urgency is meant to describe your urge to urinate. Sometimes you may feel a very strong urge to urinate and at other times, you may feel a milder urge prior to the onset of a toilet void. Rate this feeling by circling 0, 1, 2, or 3, defined as: 0: NONE – no urgency, 1: MILD – awareness of urgency, but it is easily tolerated and you can continue with your usual activity or tasks, 2: MODERATE – enough urgency discomfort that it interferes with or shortens your usual activity or tasks, 3: SEVERE – extreme urgency discomfort that abruptly stops all activity or tasks.”|baseline|||participants (per category)|||Number
754463|NCT00583219|Secondary|Urine Culture||baseline, 1 month, 3 months|||participants|||Number
754464|NCT00583219|Secondary|Postvoid Residual||baseline, 1 month, 3 months|||mL||Inter-Quartile Range|Median
754465|NCT00583219|Secondary|Mean Number of Pads Per Day||baseline, 1 month, 3 months|||pads per day||Inter-Quartile Range|Mean
754466|NCT00583219|Secondary|Blaivas-Groutz Anti-Incontinence Score at 3 Months|The Blaivas-Groutz Anti-incontinence scale was used as a measure of urinary incontinence. This scale combines information on the number of incontinent episodes in a 24-hour period, 24-hour pad weights, and a qualitative rating by the patient into a single score ranging from 0 to 6. This score is then used to categorize incontinence as none (0), mild (1-2), moderate (3-4), or severe (5-6).|3 months after treatment|||participants (per category)|||Number
754467|NCT00583219|Secondary|Blaivas-Groutz Anti-Incontinence Score at 1 Month|The Blaivas-Groutz Anti-incontinence scale was used as a measure of urinary incontinence. This scale combines information on the number of incontinent episodes in a 24-hour period, 24-hour pad weights, and a qualitative rating by the patient into a single score ranging from 0 to 6. This score is then used to categorize incontinence as none (0), mild (1-2), moderate (3-4), or severe (5-6).|1 month after treatment|||participants (per category)|||Number
754468|NCT00583219|Secondary|Blaivas-Groutz Anti-Incontinence Score at Baseline|The Blaivas-Groutz Anti-incontinence scale was used as a measure of urinary incontinence. This scale combines information on the number of incontinent episodes in a 24-hour period, 24-hour pad weights, and a qualitative rating by the patient into a single score ranging from 0 to 6. This score is then used to categorize incontinence as none (0), mild (1-2), moderate (3-4), or severe (5-6).|baseline|||participants (per category)|||Number
754469|NCT00583219|Secondary|Median 24 Hour Pad Weight|Prior to baseline and follow-up visits, the study coordinator weighed standard pads provided to the subject for the study time period. The study coordinator instructed the subject to bring in any pads used during the 24-hour period prior to baseline and follow up visits. The study coordinator recorded the 24-hour pad weights into the study dataset.|baseline, 1 month, 3 months|||g||Inter-Quartile Range|Median
754470|NCT00583219|Primary|Median Number of Incontinent Episodes During 24 Hours|The study coordinator instructed the subject to keep record of any incontinence episodes during the 24-hour period prior to their baseline and follow-up visits.|baseline, 1 month, 3 months|||number of incontinent episodes||Inter-Quartile Range|Median
754471|NCT00583362|Secondary|Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points|Serum immunoglobulin G values were assessed at Baseline, Week 8, 16, 24, 32, 40, and 48 during Year 1 to 12 and Week 8, 16, 24, 32, and 40 during Year 13, Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. For Year 1, Baseline included Extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with belimumab in the parent study. Percent change from Baseline is defined as the percentage of the difference between the post-dose post-Baseline visit value and the Baseline value.|Baseline and approximately up to 13 years|MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.||Percent change||Full Range|Median
754472|NCT00583362|Secondary|Absolute Serum Immunoglobulin G Values at Indicated Time Points|Serum immunoglobulin G values were assessed at Baseline, Week 8, 16, 24, 32, 40, and 48 during Year 1 to 12 and Week 8, 16, 24, 32, and 40 during Year 13, Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. For Year 1, Baseline included Extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with belimumab in the parent study.|Approximately up to 13 years|MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.||grams per liter||Full Range|Median
754473|NCT00583362|Secondary|Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points|Daily prednisone dose reduction was assessed at Baseline, Week 8, 16, 24, 32, 40, and 48 during Year 1 to 12 and Week 8, 16, 24, 32, and 40 during Year 13. Percentage of participants with daily prednisone dose reduced to <=7.5 mg/day from >7.5 mg/kg at the Baseline are summarized. Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study.|Approximately up to 13 years|MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.||Percentage of participants|||Number
754481|NCT00583362|Primary|Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points|Clinical chemistry parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in creatinine, urate, and bilirubin is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value.|Baseline and approximately up to 13 years|MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.||micromoles per liter||Standard Deviation|Mean
754474|NCT00583362|Secondary|Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points|Complement C3 and C4 levels were assessed in participants low at Baseline at Baseline, Week 16, 32, and 48 during Year 1 to 12, Week 16 and 32 during Year 13, and Exit visit. The Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. For Year 1, Baseline included Extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with belimumab in the parent study. Percent change from Baseline is defined as the percentage of the difference between the post-dose post-Baseline visit value and the Baseline value.|Baseline and approximately up to 13 years|MITT Population. Only those participants positive at Baseline and available at the specified time points (represented by n=X in the category titles) were analyzed.||Percent change||Full Range|Median
754475|NCT00583362|Secondary|Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points|Complement C3 and C4 levels were assessed in participants low at Baseline at Baseline, Week 16, 32, and 48 during Year 1 to 12, Week 16 and 32 during Year 13, and Exit visit. The Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. For Year 1, Baseline included Extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with belimumab in the parent study.|Approximately up to 13 years|MITT Population. Only those participants positive at Baseline and available at the specified time points (represented by n=X in the category titles) were analyzed.||grams per liter||Full Range|Median
754476|NCT00583362|Secondary|Median Percent Change From Baseline in Anti-double Stranded DNA in Participants Positive at Baseline at Indicated Time Points|Anti-double stranded DNA levels for participants positive at Baseline were assessed at Baseline, Week 16, 32, and 48 during Year 1 to 11, Week 16 and 32 during Year 13, Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). The Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. For Year 1, Baseline included Extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with belimumab in the parent study. Percent change from Baseline is defined as the percentage of the difference between the post-dose post-Baseline visit value and the Baseline value.|Baseline and approximately up to 13 years|MITT Population. Only those participants positive at Baseline and available at the specified time points (represented by n=X in the category titles) were analyzed.||Percent change||Full Range|Median
754477|NCT00583362|Secondary|Observed Anti-double Stranded DNA Levels in Participants Positive at Baseline at Indicated Time Points|Anti-double stranded DNA levels in participants positive at Baseline were assessed at Baseline, Week 16, 32, and 48 during Year 1 to 11, Week 16 and 32 during Year 13, Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). The Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. For Year 1, Baseline included Extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with belimumab in the parent study.|Approximately up to 13 years|MITT Population. Only those participants positive at Baseline and available at the specified time points (represented by n=X in the category titles) were analyzed.||International units (IU)/milliliter (mL)||Full Range|Median
754478|NCT00583362|Secondary|Percentage of Participants Achieving SLE Responder Index (SRI) Response at Indicated Time Points|SRI response was assessed at Week 16, 32, and 48 during Year 1 to 12 and Week 16 and 32 during Year 13. Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. SRI response is defined as:>=4 point reduction from the Baseline in safety of estrogen in lupus national assessment (SELENA) SLE disease activity index (SLEDAI) score and no worsening (increase of <0.30 points from the Baseline) in Physician's Global Assessment (PGA), and no new British Isles Lupus Assessment Group (BILAG) A organ domain score or 2 new BILAG B organ domain scores compared with the Baseline at the time of assessment.|Approximately up to 13 years|MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.||Percentage of participants|||Number
754479|NCT00583362|Primary|Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points|Clinical chemistry parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in ALT, AP, AST, GGT and LD are summarized. Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value.|Baseline and approximately up to 13 years|MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.||International units per liter||Standard Deviation|Mean
754480|NCT00583362|Primary|Change From Baseline in BUN/Creatinine at the Indicated Time Points|Clinical chemistry parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in BUN/creatinine is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value.|Baseline and approximately up to 13 years|MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.||Ratio||Standard Deviation|Mean
754482|NCT00583362|Primary|Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points|Clinical chemistry parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in BUN, glucose, calcium, carbon dioxide, chloride, magnesium, phosphate, potassium and sodium is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value.|Baseline and approximately up to 13 years|MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.||millimoles per liter||Standard Deviation|Mean
754483|NCT00583362|Primary|Change From Baseline in Albumin and Protein at the Indicated Time Points|Clinical chemistry parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in albumin and protein is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value.|Baseline and approximately up to 13 years|MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.||grams/liter||Standard Deviation|Mean
754484|NCT00583362|Primary|Change From Baseline in Hemoglobin at the Indicated Time Points|Hematology parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in hemoglobin is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value.|Baseline and approximately up to 13 years|MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.||grams per liter||Standard Deviation|Mean
754485|NCT00583362|Primary|Change From Baseline in Hematocrit at the Indicated Time Points|Hematology parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in hematocrit is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value.|Baseline and approximately up to 13 years|MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.||Percentage of blood by volume||Standard Deviation|Mean
754486|NCT00583362|Primary|Change From Baseline in Erythrocytes at the Indicated Time Points|Hematology parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in erythrocytes is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value.|Baseline and approximately up to 13 years|MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.||10^12 per liter||Standard Deviation|Mean
754487|NCT00583362|Primary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points|Hematology parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in basophils, eosinophils, lymphocytes, monocytes, neutrophils segmented and platelets is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value.|Baseline and approximately up to 13 years|MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.||10^9 per liter||Standard Deviation|Mean
754488|NCT00583362|Primary|Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points|Hematology parameters were assessed at Baseline, Week 8, 16, 24, 40, and 48 during Year 1 to 8; Week 8, 16, 24, and 40 during Year 9; Week 24 and 40 during Year 10; Week 48 during Year 11; Week 32 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in APTT and PT is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value.|Baseline and approximately up to 13 years|MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.||Seconds||Standard Deviation|Mean
754509|NCT00583622|Primary|Event-Free (EF) Rate|Percent of participants free of relapse or disease progression at end of 6 months. Event-free survival estimated from the first day of High-dose chemotherapy (day-6) until tumor progression, relapse, or death from any cause.|Up to 6 Months|Due to the small number of patients treated, 12 out of 30 planned, an analysis was not possible.|||||
754569|NCT00584727|Primary|Visual Acuity|Number of eyes with Distance Visual Acuity 20/20 or better|15-20 minutes|Analysis includes participants who completed the study per protocol (n=88 subjects,176 eyes)||Eyes with Snellen VA 20/20 or better|||Number
754489|NCT00583362|Primary|SAE Rates by System Organ Class (SOC) During the Study|SAE rates by SOC adjusting for participant-years on study drug anytime post Baseline are summarized, which included the follow up visits. Only treatmentemergent SAEs are summarized. The Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pretreatment value in the parent study for participants treated with belimumab in the parent study. The event rate of an SAE was calculated as the number of events per 100 participant years: Event Rate=100* number of events divided by participant years. Participant years were calculated as sum across all participants ([last visit of interval day minus first visit of interval day plus 1] divided by 365).|Approximately up to 13 years|MITT population||Events per 100 participant years|||Number
754490|NCT00583362|Primary|Adverse Event (AE) Rates by System Organ Class (SOC) During the Study|AE rates by SOC adjusting for participant-years on study drug anytime post Baseline are summarized, which included the follow up visits. Only treatmentemergent AEs are summarized. The Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. The event rate of an AE was calculated as the number of events per 100 participant years: Event Rate=100* number of events divided by participant years. Participant years were calculated as sum across all participants ([last visit of interval day minus first visit of interval day plus 1] divided by 365).|Approximately up to 13 years|MITT Population||Events per 100 participant years|||Number
754491|NCT00583362|Primary|Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs)|An AE is defined as any unfavorable or unintended sign, symptom, or disease that is temporally associated with the use of a study agent but is not necessarily caused by the study agent. This includes worsening (example [eg], increase in frequency or severity) of pre-existing conditions. An SAE is defined as an AE resulting in any of the following outcomes: death, is life threatening (that is, an immediate threat to life), inpatient hospitalization, prolongation of an existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, and is medically important.|Approximately up to 13 years|MITT Population. Only those participants available at the specified time points (represented by n=X, in the category titles) were analyzed.||Participants|||Number
754492|NCT00583453|Secondary|Total Morphine Equivalent|Participant reported mophine equivalent use|From operative day through 10 days post-operative|||mg||Standard Error|Mean
754493|NCT00583453|Secondary|Incidence of Post-operative Hemorrhage|The incidence of post-operative hemorrhage, defined as post-operative bleeding requiring medical intervention or hospitalization during the 10 day post-operative follow-up period.|From operative day through 10 days post-operative|||Participants|||Count of Participants
754494|NCT00583453|Secondary|Acetaminophen Equivalent Use|Participant reported acetaminophen use and its equivalent. Medication use was collected from reported participant journals.|From operative day through 10 days post-operative|||mg||Standard Error|Mean
754495|NCT00583453|Secondary|Self-reported Activity Level|Activity level, reported by participant utilizing a 10-point ordinal scale (0 = no activity, 10 = return to normal activities). Activity level was measured was collected once daily.|From operative day through 10 days post-operative|||Activity score (units on a scale)||Standard Error|Mean
754496|NCT00583453|Primary|Self-reported Pain Score|Pain score as reported by participant, measured on a 10 point scale, where 0 = none and 10 = unbearable, collected once daily.|day of procedure through post-operative day 10|||pain score (units on a scale)||Standard Error|Mean
754497|NCT00583466|Primary|Duration of the Submucosal Cushion||Immediately after the procedure, Up to 5 minutes|No data is available for this record. The PI has left the institution and has been contacted. Per the PI the data is no longer available and the study has not been published.|||||
754498|NCT00583492|Secondary|Decrease in Quality of Life|Quality of Life was measured using the comprehensive Expanded Prostate Cancer Index Composite (EPIC) instrument 19 and 20|3 years|||participants|||Number
754499|NCT00583492|Secondary|Disease-specific Survival||10 years|||participants|||Number
754500|NCT00583492|Secondary|Freedom From Distant Metastases||10 years|||participants|||Number
754501|NCT00583492|Secondary|Positive Prostate Biopsy at 2 Years||2 years|||participants|||Number
754502|NCT00583492|Secondary|Acute >= Grade 3 Treatment-related Toxicity|This metric includes both expected and unexpected events Toxicities were graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events, version 3|90 days|||percentage of adverse events|||Number
754503|NCT00583492|Primary|Freedom From Biochemical/Clinical Failure (FFF)|Biochemical/Clinical Failure was defined as PSA nadir plus 2 ng/mL|5 years|||participants|||Number
754504|NCT00583557|Secondary|The Efficacy Endpoints Will Include Long-term ACR Responses, DAS28 Response, C-reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR), and Rheumatoid Factor (RF).|NOT ANALYZED|up to 5 Years||||||
754505|NCT00583557|Primary|To Evaluate the Long-term Safety of LymphoStat-B™ in Subjects With RA.|SEE ALSO ADVERSE EVENT (AE) RESULTS SECTION.|Up to 5 years|||Particpants|||Number
754506|NCT00583596|Primary|Reporting of Late Efficacy Issues Regarding Patent Ductus Arteriosis (PDA) Closure|The number of participants with a residual shunt (efficacy)|Long term follow up data captured at 5, 6 or 7 years post implant|Of the 152 subjects that completed long term follow-up, 128 subjects underwent Transthoracic echocardiogram (TTE) at their final visit.||participants|||Number
754507|NCT00583596|Primary|Reporting of Late Adverse Events Relating to the Device.||Long term follow up for data captured at 5, 6 or 7 years post implant|152 subjects of the 436 subjects eligible for post market survelliance completed a 5, 6 or 7 year follow-up.||participant|||Number
754508|NCT00583622|Secondary|Participant Response|Number of participants evaluated using Response to Treatment in Solid Tumors (RECIST) with definitions of Complete Response (CR): disappearance of all target lesions; and, Partial Response: at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Maintained Continued CR: participants who entered study in a CR and maintained CR post study treatment. Evaluations once a week till Day +30, then Days 30, 60, and 100 then at 6 months or until disease progression.|Up to 6 months|One participant was not evaluable for response as participant expired prior to performing restaging evaluation.||percentage of participants|||Number
754587|NCT00584909|Secondary|Toxicity|Toxicity secondary to paclitaxel and carboplatin based upon the NCI common toxicity criteria version|4 years|||participants|||Number
754511|NCT00583661|Primary|The Safety of EXCOR® Pediatric Was Evaluated by Summarizing the Serious Adverse Event Rate Experienced While the Subject Was Supported on the Device.|The serious adverse event rate was calculated by totaling the number of serious adverse events all subjects experienced during device support (from implant to explant, an average of 58 days) divided by the total support time (in days) for all subjects. The serious adverse event rates were calculated separately for each primary study cohort.|Participants were followed while on device support, an average of 58 days|All 48 participants were included in the analysis. Adverse Events for each participant was counted and the total number of events was divided by the total time the Cohort's subjects were supported on device. A 95% Poisson confidence interval was calculated around the point estimates.||Events per patient-day||95% Confidence Interval|Number
754512|NCT00583700|Secondary|Tissue Compliance|"Tissue compliance meter measurements of the treated breast compared to the non-treated breast were obtained at 18 months post-radiation therapy. Tissue compliance simply means how soft and pliable the breast tissue is when force is applied to it.
One physician would hold the tissue compliance meter (TCM) against the participant's skin. A standard amount of force would be applied. A second physician would read the displacement scale for a specific set of areas on the breast. The range of the scale was 0 to 60 milimeters (mm). The physician's were blineded to the participant's intervention at the time of measurement.
The final value is the difference between the untreated and the treated breast [untreated - treated]. The range of these differences was -3.3 to 7.0 mm."|18 months post-treatment|All study participants enrolled were to be measured at 18 months post-radiotherapy. The number of participants analyzed varied by the number compliant with study schedule.||milimeters (mm)||Standard Deviation|Mean
754513|NCT00583700|Primary|Subjective, Objective, Management, and Analytic (SOMA) Score|A primary outcome of interest is the composite Subjective, Objective, Management, and Analytic (SOMA) score at 18-month follow-up visit. Maximum score is 45, with a score of 0 being ideal and representing no treatment-related side effects at the study visit.|18 month post-treatment|All participants enrolled in the study were evaluated for SOMA scores. Numbers varied by study participants compliance with follow-up appointments.||units on a scale||Standard Deviation|Mean
754514|NCT00583713|Primary|Elimination Rate Constant||1 day|||1/hr||Standard Deviation|Mean
754515|NCT00583713|Primary|Area Under the Curve for the 24-hour Dosing Interval||1 day|||µmol*hr/L||Standard Deviation|Mean
754516|NCT00583713|Primary|Terminal Half-life||1 day|||hours||Standard Deviation|Mean
754517|NCT00583713|Primary|Time to Maximum Concentration||1 day|||hours||Standard Deviation|Mean
754518|NCT00583713|Secondary|Urinary Sulfate Concentration||pre-dose to 6 days post-dose|||mg/dL||Standard Deviation|Mean
754519|NCT00583713|Primary|Maximum Observed Concentration (Cmax)||1 day|||µmol/L||Standard Deviation|Mean
754520|NCT00583908|Secondary|Degree of Lens Rotation in Inferior Gaze.|Degree of lens rotation while participant is gazing down.|After each of the four lens insertions|Only participants who completed the study per protocol. Some participants had missing data for some of the lenses.||Degree of rotation||Standard Deviation|Mean
754521|NCT00583908|Secondary|Degree of Lens Rotation in Inferior-nasal Gaze.|Degree of lens rotation while participant is gazing down and in.|After each of the four lens insertions|Only participants who completed the study per protocol. Some participants had missing data for some of the lenses.||Degree of rotation||Standard Deviation|Mean
754522|NCT00583908|Secondary|Degree of Lens Rotation Inferior-temporal Gaze.|Degree of lens rotation while participant is gazing down and out.|After each of the four lens insertions|Only participants who completed the study per protocol. Some participants had missing data for some of the lenses.||Degree of rotation||Standard Deviation|Mean
754523|NCT00583908|Secondary|Degree of Lens Rotation in Nasal Gaze.|Degree of lens rotation while participant is gazing in(towards the nose).|After each of the four lens insertions|Only participants who completed the study per protocol. Some participants had missing data for some lenses.||Degree of rotation||Standard Deviation|Mean
754524|NCT00583908|Secondary|Degree of Lens Rotation in Temporal Gaze.|Degree of lens rotation while participant is gazing out(towards the temple).|After each of the four lens insertions|Only participants who completed the study per protocol. Some participants had missing data for some lenses.||Degree of rotation||Standard Deviation|Mean
754525|NCT00583908|Secondary|Degree of Lens Rotation in Superior-nasal Gaze.|Degree of lens rotation while participant is gazing up and in(towards the nose).|After each of the four lens insertions|Only participants who completed the study per protocol. Some participants had missing data for some lenses.||Degree of rotation||Standard Deviation|Mean
754526|NCT00583908|Secondary|Degree of Lens Rotation in Superior-temporal Gaze.|Degree of lens rotation while participant is gazing up and out(towards the temple).|After each of 4 lens insertions.,|Only participants who completed the study per protocol. Some participants had missing data for some lenses.||Degree of rotation||Standard Deviation|Mean
754527|NCT00583908|Secondary|Degree of Lens Rotation in Superior Gaze.|Degree of lens rotation while participant is gazing up.|After each of the four lens insertions|Only participants who completed the study per protocol. Some participants had missing data for some lenses.||Degree of rotation||Standard Deviation|Mean
754528|NCT00583908|Primary|Visual Acuity During Head Tilt|"logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity.
logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal."|after each of the four lens insertions|Only participants who completed the study per protocol. Some participants had missing data for some of the lenses.||logMAR units||Standard Deviation|Mean
754529|NCT00583908|Primary|Lens Orientation During Head Tilt.|Degree of lens rotation on the eye with the head tilted.|after fit of each of the four lens insertions|Only participants who completed the study per protocol. Some participants had missing data for some lenses.||Degree of rotation||Standard Deviation|Mean
754530|NCT00583947|Secondary|Plasma Concentration of (R,R) Formoterol|If the mean plasma concentration was 'below the limit of quantification' (BLQ) which was set as <=0.5 picograms/milliliter, the value is displayed as a zero.|predose, various postdose times|PK population consisted of subjects who were in the intent-to-treat population and had any plasma concentration data available.||picogram/milliliter||Standard Deviation|Mean
754588|NCT00584909|Primary|Disease-free Survival|Number of months of survival with no evidence of disease|4 years - Median follow up time of 45.3 months|||months||Full Range|Median
754589|NCT00584935|Secondary|2. Stability of Visual Acuity (Snellen's Test) at 24 Weeks||24 weeks||||||
754531|NCT00583947|Secondary|Change From Predose in Mean Peak Expiratory Flow Rate (PEFR)|PEFR is the fastest rate at which air can move through the airways during a forced expiration starting with fully inflated lungs as measured by peak flow meters. Change in PEFR was calculated as postdose value minus the predose value at each visit.|predose, various postdose times|Intent to treat population. Pulmonary function testing was only performed on subjects six years of age or older; there were no subjects five or younger who performed spirometry. Subject data for those who were misdosed with ARF 7.5mcg rather than ARF 15mcg in the open-label portion were excluded from these analyses.||liters/second||Standard Deviation|Mean
754532|NCT00583947|Secondary|Mean Peak Expiratory Flow Rate (PEFR)|PEFR is the fastest rate at which air can move through the airways during a forced expiration starting with fully inflated lungs as measured by peak flow meters.|predose, various postdose times|Intent to treat population. Pulmonary function testing was only performed on subjects six years of age or older; there were no subjects five or younger who performed spirometry. Subject data for those who were misdosed with ARF 7.5mcg rather than ARF 15mcg in the open-label portion were excluded from these analyses.||liters/second||Standard Deviation|Mean
754533|NCT00583947|Secondary|Change From Predose of Mean Forced Expiratory Volume in One Second (FEV1)|Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer. Change in FEV1 was calculated as postdose value minus the predose value at each visit.|predose, various postdose timepoints|Intent to treat population. Pulmonary function testing was only performed on subjects six years of age or older; there were no subjects five or younger who performed spirometry. Subject data for those who were misdosed with ARF 7.5mcg rather than ARF 15mcg in the open-label portion were excluded from these analyses||liters||Standard Deviation|Mean
754534|NCT00583947|Primary|Change From Predose in Mean Serum Glucose|Change in mean serum glucose at the specified timepoint minus the predose value.|predose, 2 and 6 hours post dose|Intent to treat population||mg/dl||Standard Deviation|Mean
754535|NCT00583947|Primary|Mean Serum Glucose Values||Predose, 2 and 6 hours post dose 1|Intent to treat population||mg/dl||Standard Deviation|Mean
754536|NCT00583947|Primary|Change From Predose in Mean Serum Potassium|Change in mean serum potassium at the specified timepoint minus the predose value.|predose, 2 and 6 hours post dose|Intent to treat population||mEq/L||Standard Deviation|Mean
754537|NCT00583947|Primary|Mean Serum Potassium Levels||Predose, 2 hours and 6 hours postdose 1|Intent to treat population||mEq/L||Standard Deviation|Mean
754538|NCT00583947|Primary|Change From Predose in Mean Diastolic Blood Pressure|Mean diastolic blood pressure measured at various timepoints minus the predose diastolic blood pressure|predose, various timeframes up to 5 hours post last dose|Intent to treat population||mmHg||Standard Deviation|Mean
754539|NCT00583947|Primary|Mean Diastolic Blood Pressure|Diastolic blood pressure measured at various timepoints: predose and timepoints after each of the three dosings. Each treatment consists of one nebulization every 30 minutes over a 60 minute treatment interval (totaling 3 cumulative dosings at 0,30 and 60 minutes).|predose, various timeframes up to 5 hours post last dose|Intent to treat population||mmHg||Standard Deviation|Mean
754540|NCT00583947|Primary|Change From Predose in Mean Systolic Blood Pressure|Mean systolic blood pressure measured at various timepoints minus the mean systolic blood pressure at predose|predose, various timeframes up to 5 hours post last dose|Intent to treat population||mmHg||Standard Deviation|Mean
754541|NCT00583947|Primary|Mean Systolic Blood Pressure|Systolic blood pressure measured at various timepoints: predose and timepoints after each of the three dosings. Each treatment consists of one nebulization every 30 minutes over a 60 minute treatment interval (totaling 3 cumulative dosings at 0,30 and 60 minutes).|predose, various timeframes up to 5 hours post last dose|Intent to treat population||mmHg||Standard Deviation|Mean
754542|NCT00583947|Primary|Change From Predose in Mean Heart Rate|Heart rate measured at various timepoints minus the heart rate at predose.|predose, various timeframes up to 5 hours post last dose|Intent to treat population||beats per minute||Standard Deviation|Mean
754543|NCT00583947|Secondary|Mean Forced Expiratory Volume in One Second(FEV1)|Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer.|predose, various postdose times|Intent to treat population. Pulmonary function testing was only performed on subjects six years of age or older; there were no subjects five or younger who performed spirometry. Subject data for those who were misdosed with ARF 7.5mcg rather than ARF 15mcg in the open-label portion were excluded from these analyses.||liters||Standard Deviation|Mean
754544|NCT00583947|Primary|Mean Heart Rate|Heart rate measured at various timepoints: predose and timepoints after each of the three dosings. Each treatment consists of one nebulization every 30 minutes over a 60 minute treatment interval (totaling 3 cumulative dosings at 0,30 and 60 minutes).|predose, various timeframes up to 5 hours post last dose|Intent to treat population||beats per minute||Standard Deviation|Mean
754545|NCT00584077|Secondary|to Assess the Presence and Strength of the Cough Reflex in the Lower Airway for up to One Year||15-20 minutes||||||
754546|NCT00584077|Primary|Evaluate the Presence and Strength of the Cough Reflex in the Lower Airway|Presence of cough as elicited by placement of biopsy forceps or instillation of dextrose solution on the airway mucosa. The presence of the cough reflex will be assessed with administartion of mecahnical (Biopsy foreceps) and chemical (dextrose solution) at the level of the main carina, native lung airway and proximal and distal to the airway anastomosis.|15-20 minutes|||coughs||Standard Deviation|Mean
754547|NCT00584194|Secondary|Immunogenicity: Geometric Mean Titers After 6-month Booster|Measurement is the 80% plaque-reduction neutralization titer (PRNT80) for study Parts A and B.|month 6 after dose 4|Population is based on responders (defined as a subject achieving a PRNT80 >1:40)||Titers||95% Confidence Interval|Geometric Mean
754548|NCT00584194|Secondary|Immunogenicity: Geometric Mean Titers at 12 Months|Measurement is the 80% plaque-reduction neutralization titer (PRNT80) for study Parts A and B.|at 12 months|Population is based on responders (defined as a subject achieving a PRNT80 >1:40)||Titers||95% Confidence Interval|Geometric Mean
754549|NCT00584194|Secondary|Immunogenicity: Geometric Mean Titers Before 6-month Booster|Measurement is the 80% plaque-reduction neutralization titer (PRNT80) for study Parts A and B|Before 6-month booster|Population is based on responders (defined as a subject achieving a PRNT80 >1:40)||Titers||95% Confidence Interval|Geometric Mean
754590|NCT00584935|Secondary|1. Stability of Visual Acuity (Snellen's Test) at 16 Weeks||16 weeks||||||
754553|NCT00584220|Primary|Subjective Reported Vision|A weighted combined score of one week and two week data calculated from individual vision-related questions asked on a 1-5 scale, 1 = most negative response to 5 = most positive, was used to derive vision outcomes. The analysis shows the outcome for both senofilcon A and alphafilcon A. If score >0 then greater vision, if <0 then lesser vision.|1 week|Analysis includes only participants who completed the study per protocol and had no missing data.||Units on a scale||Standard Deviation|Least Squares Mean
754554|NCT00584402|Secondary|Number of Participants With an Increase in Echogenicity (Brightness) of Small Intrahepatic Tumors Following Contrast-enhanced Sonography Based on Tumor Type, Size, Location and Depth|Visual estimation of the the effect of tumor type, size, location and depth on the conspicuity of small tumors on contrast-enhanced sonography using prior assessment or pathology for tumor type|15 min|Tumor types showed differences in enhancement||participants|||Number
754555|NCT00584402|Primary|Percent of Tumors With Increased Echogenicity (Brightness) Following Contrast-enhanced Sonography|After the systemic iv injection of ultrasound contrast, the real time ultrasound images are visually evaluated, and small intrahepatic tumors are detected on the images. The images pre-contrast and post contrast are compared visually. One tumor per participant was analyzed.|15 min|Tumors were evaluated prior and post contrast injection, 1 tumor per participant||tumor|tumor||Count of Units
754556|NCT00584415|Secondary|Total Number of Significant Ablation Procedure Related Complications|Any complication directly related to the ablation procedure was included. These complications included pericardial effusion, cardiac tamponade, excessive bleeding requiring transfusion, phrenic nerve injury, atrio-esophageal fistula, vascular access complications, myocardial infarction and stroke.|0-1 year|||Complications|||Number
754557|NCT00584415|Primary|Atrial Tachyarrhythmia Recurrence in Participants|Outcome is determined by recurrence of atrial tachyarrhythmia in participants. Outcome is measured by any atrial tachyarrhythmias recorded by 12-lead ECGs, Holter monitoring or event monitoring. Recurrence of atrial tachyarrhythmia is also measured by symptoms reported by patients. Symptoms include palpitations, dizziness, dyspnea and any AF-related symptoms that existed before AF ablation.|0-5 years|all patients referred for paroxysmal AF ablation between 1-2004 and 12-2005 were included||participants|||Number
754558|NCT00584454|Primary|The Adverse Reaction and Occupational Illness Endpoint Measurements in This Q Fever NDBR 105 Vaccine Study Will be Evaluated for All Intent-to-treat Volunteers.|Observe adverse reactions and occupational illness endpoint measurements 7 days follow-up after receipt of skin test antigen and 12 months of follow-up after receipt of vaccine|AEs recorded through day 28 after vaccination; SAEs recorded through duration of study; Confirmed occupational illness recorded through duration of study|Subjects at risk of exposure to Coxiella Burnetti (Q Fever)||Participants|||Count of Participants
754559|NCT00584480|Primary|Number of Participants With the Given Clinical Global Impression Scale - Improvement (CGI-I) Score|Assessment of global changes in severity of autistic symptoms. CGI-I scores formulated by the clinician based on parent interview of changes in the child's behavior and from direct clinical observation, where scores of 0 = no improvement,1 = minimally improved, 2 = much improved, and 3 = very much improved.|Baseline, 8 Weeks from baseline, and 20 Weeks from baseline|||participants|||Number
754560|NCT00584558|Secondary|Number of Patients With Complications From Catheter Ablation|Number and % of patients with major adverse events as recorded in the medical record|0-10 years|||Participants|||Count of Participants
754561|NCT00584558|Primary|Number of Patients With Arrhythmia Recurrence|Number and % patients with documented arrhythmias recurrences|0-10 years|Patients who underwent ablation of arrhythmias||Participants|||Count of Participants
754562|NCT00584701|Secondary|Exon Expression Positively or Negatively Correlated With Percentage Improvement in ABC-I|"Affymetrix GeneChip Human Exon 1.0 ST Arrays (Affymetrix, Santa Clara, CA, USA) were used to obtain gene expression values. Raw data (Affymetrix.CEL files) was imported into Partek Genomics Suite 6.4 (Partek, St Louis, MO, USA). Probe summarization and probe set normalization were performed using robust multichip average, which included background correction, quantile normalization, log2 transformation and median polish probe set summarization.
Exons in genes correlated with percentage improvement on the Aberrant Behavior Checklist Irritability subscale were identified."|Baseline, 8 Weeks|||Number of Correlated Genes|||Number
754563|NCT00584701|Primary|Percent Change of ABC - Irritability Subscale Score|"Aberrant Behavior Checklist-Irritability (ABC-I)subscale: measure of assessing changes in symptoms of irritability in children with autism (survey that was normed on a developmentally delayed population of children and adults and is usually completed by a parent or caregiver. There are 45 items that are rated on a 4-point scale from “no problem” to “major problem. ABC-I scores ranges from 0 (best) to 45 (worst). A negative change signifies improvement.
We measured percent change of ABC-I scores from 8 weeks after risperidone treatment compared to baseline."|Baseline, 8 weeks|||percent change in scores||Full Range|Mean
754564|NCT00584727|Primary|Patient Preference|This outcome measures which lens the subjects preferred to wear.|end of study|Analysis includes participants who completed the study per protocol (n=88)||Number of participants|||Number
754565|NCT00584727|Primary|Patient Reported Comfort.|A weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale, 1=most negative response to 5=most positive response, was used to derive comfort outcomes. The analysis shows the difference in outcome between the test and control. >0=comfortable, <0=uncomfortable|15-20 minutes|Analysis includes participants who completed the study per protocol (n=88)||Scores on a scale||Standard Error|Least Squares Mean
754566|NCT00584727|Primary|Lens Stability Within 5 Degrees|Measures if the lens changes position on the eye as it is worn and is measured in degrees of rotation.|1 minute|Analysis includes participants who completed the study per protocol (n=88 subjects, 176 eyes)||degrees|||Number
754567|NCT00584727|Primary|Lens Orientation Within 5 Degrees|Meaures in what position does the lens sit on the eye at insertion and is measured in degrees of rotation.|1 minute|Analysis includes participants who completed the study per protocol (n=88 subjects, 176 eyes)||degrees|||Number
754568|NCT00584727|Primary|Patient Reported Vision|A weighted combined score calculated from individual confort-vision related questions asked on a 1-5 scale, 1=most negative resonse to 5=most positive response, was used to derive vision scores. The analysis shows the difference in outcome between test and control. >0=greater vision, <0=lesser vision.|15-20 minutes|Analysis includes participants who completed the study per protocol (n=88)||Scores on a scale||Standard Error|Least Squares Mean
782716|NCT00807560|Secondary|BMI|Body Mass Index: this variable informs the calculation of the primary outcome variable of BMI z-score.|up to 44 weeks|||kg/m^2||Standard Deviation|Mean
754570|NCT00584740|Primary|Mean Change From Baseline in Crohns Disease Activity Index (CDAI) Score|The Crohns Disease Activity Index or CDAI is a research tool used to quantify the symptoms of patients with Crohns disease. Participants were asked to record on a paper diary the frequency of stools, abdominal pain and general well-being on a daily basis. In addition to the diary data, the investigator assessed the following for the calculation of CDAI score: arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenousum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula; fever; use of antidiarrheal; abdominal mass; hematocrit; body weight. The CDAI score is the sum of the products of each item multiplied by its weighting factor. CDAI ranges from 0 to >=600, where remission of Crohn's disease is defined as CDAI < 150, and severe disease is defined as CDAI > 450. A negative change in mean score indicates improvement.|6 weeks|Safety Analysis Set: the safety set included all participants.||score on a scale||Standard Deviation|Mean
754571|NCT00584740|Secondary|Percentage of Participants Maintaining Remission|Remission was defined as CDAI < 150 points.|10 weeks|The analysis population included participants of the safety set who achieved remission.||Percentage of participants|||Number
754572|NCT00584740|Secondary|Area Under CDAI Curve|The Crohns Disease Activity Index or CDAI is a research tool used to quantify the symptoms of patients with Crohns disease. Participants were asked to record on a paper diary the frequency of stools, abdominal pain and general well-being on a daily basis. In addition to the diary data, the investigator assessed the following for the calculation of CDAI score: arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenousum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula; fever; use of antidiarrheal; abdominal mass; hematocrit; body weight. The CDAI score is the sum of the products of each item multiplied by its weighting factor. CDAI ranges from 0 to >=600, where remission of Crohn's disease is defined as CDAI < 150, and severe disease is defined as CDAI > 450. An area under the CDAI response curve analysis was performed with a starting point from week 4.|10 weeks|Safety Analysis Set: the safety set included all participants.||Units on a scale*day||Standard Error|Least Squares Mean
754573|NCT00584740|Secondary|Mean Change From Baseline in CDAI Score|The Crohns Disease Activity Index or CDAI is a research tool used to quantify the symptoms of patients with Crohns disease. Participants were asked to record on a paper diary the frequency of stools, abdominal pain and general well-being on a daily basis. In addition to the diary data, the investigator assessed the following for the calculation of CDAI score: arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenousum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula; fever; use of antidiarrheal; abdominal mass; hematocrit; body weight. The CDAI score is the sum of the products of each item multiplied by its weighting factor. CDAI ranges from 0 to >=600, where remission of Crohn's disease is defined as CDAI < 150, and severe disease is defined as CDAI > 450. A negative change in mean score indicates improvement.|baseline, 2 weeks, 4 weeks|Safety Analysis Set: the safety set included all participants.||score on a scale||Standard Deviation|Mean
754574|NCT00584740|Secondary|Percentage of Participants Achieving Response|Response was defined as CDAI reduction of at least 70 points from baseline.|6 weeks|Safety Analysis Set: the safety set included all participants.||Percentage of participants|||Number
754575|NCT00584740|Secondary|Percentage of Participants Achieving Remission|Remission was defined as CDAI < 150 points.|6 weeks|Safety Analysis Set: the safety set included all participants.||Percentage of participants|||Number
754576|NCT00584740|Secondary|Percentage of Participants Achieving Remission and/or Response|Remission or response was defined as CDAI < 150 points or CDAI reduction from baseline of at least 70 points.|6 weeks|Safety Analysis Set: the safety set included all participants.||Percentage of participants|||Number
754577|NCT00584831|Primary|Visual Acuity After Superior-nasal Version Movement.|logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.|10 minutes after lens insertion|||LogMAR units||Standard Deviation|Mean
754578|NCT00584831|Primary|Visual Acuity After Superior-temporal Version Movement|logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.|10 minutes after lens insertion|||LogMAR units||Standard Deviation|Mean
754579|NCT00584831|Primary|Visual Acuity After Infero-nasal Version Movement.|logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.|10 minutes after lens insertion|||LogMAR units||Standard Deviation|Mean
754580|NCT00584831|Primary|Visual Acuity After Infero-temporal Version Movement.|logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.|10 minutes after insertion|||LogMAR units||Standard Deviation|Mean
754581|NCT00584844|Secondary|Immunogenicity: Protocol-compliant Post-boost 2 Titer|"Percentage of subjects with less than or greater than titers who received post-boost 2.
Responder = > 1:20 Non-responder = < 1:20"|12 months|As stated in the protocol, only titers taken in compliance with the prescribed schedule were used in the statistical analysis. 18 were compliant and analyzed.||Percentage of subjects|||Number
754582|NCT00584844|Secondary|Immunogenicity: Protocol-compliant Post-boost 1 Titer Rates|Percentage of subjects with less than or greater than titers (> or < 1:20) who received post-boost 1|12 months|As stated in the protocol, only titers taken in compliance with the prescribed schedule were used in the statistical analysis. 19 were compliant and analyzed.||Percentage of subjects|||Number
754583|NCT00584844|Secondary|Immunogenicity: Protocol Compliant Post-primary Titer Rates|Percentage of subjects with less than or greater than titers (> or < 1:20) for compliant post-primary titers.|12 months|As stated in the protocol, only titers taken in compliance with the prescribed schedule were used in the statistical analysis. 454 were compliant and analyzed.||Percentage of subjects|||Number
754584|NCT00584844|Primary|Safety: Adverse Event Category Rates for All Vaccinations|AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule.|AEs/SAEs recorded through duration of study; immunogenicity via MA on days 0, 28-35, 56-84, and at 1 year|||Adverse events|||Number
754585|NCT00584857|Secondary|Toxicity|Toxicity secondary to paclitaxel, carboplatin, and megesterol acetate based on NCI common toxicity criteria|3 years|||participants|||Number
754586|NCT00584857|Primary|3-year Overall Survival|Number of subjects alive at 3 years|3 years - median followup of 40.4 months|||partipants|||Number
754592|NCT00584935|Primary|Number of Participants With no Evidence of Further Scarring (Fosters Staging) at 16 Weeks|"Stages Characteristics I Subconjunctival scarring and fibrosis II Fornix foreshortening (a-d describes % loss of inferior fornix depth)
0-25%
25-50%
50-75%
75-100% III Presence of symblepharon and number (n) (a-d describes % of horizontal involvement by sympblephara and n is the number of symblephara countable)
a. 0-25% b. 25-50% c. 50-75% d. 75-100% IV Ankyloblepharon, frozen globe"|16 weeks|||participants|||Number
754593|NCT00584948|Primary|Change From Baseline in Intention Tremor as Measured by the CATSYS Tremor Scale|The CATSYS is a set of computer assisted diagnostic instruments that can measure intention tremor, postural tremor, postural sway, manual coordination and reaction time. The tremor intensity is defined as the root mean square of accelerations, recorded in the 0.9 Hz to 15.0 Hz band during the test period. Unit is measured in m/s2|1 year|||m/s^2||Standard Deviation|Mean
754594|NCT00584948|Primary|Change From Baseline in Executive Functioning as Measured by the Behavioral Dyscontrol Scale II (BDS-II)|The BDS-II is a 9-item, 27-point instrument that measures executive function as the capacity for behavioral and attentional self-regulation. Total score is a sum of the 9 items, with a range of 0-27, in which a higher score indicates a better performance.|One Year|||units on a scale||Standard Deviation|Mean
754595|NCT00584987|Secondary|Total NPIF|Nasal peak inspiratory flow (NPIF) is a physiological measure of nasal airflow which is particularly sensitive to nasal valve collapse. NPIF was measured objectively in liters per minute with an In-Check Peak Inspiratory FlowMeter (Ferraris Medical Inc, Orchard Park, NY). Subjects obtained 3 readings every morning and every evening and recorded the best flow measured. The morning and evening NPIF measurements were summed for days 2 through 28 of the treatment cycle, yielding the total NPIF outcome measure. NPIF scores increase with air flow quality (i.e., higher NPIF values are indicative of better nasal air flow).|days 2 through 28 of the treatment cycle|||liters per minute||Full Range|Median
754596|NCT00584987|Secondary|RQLQ Score [6 Weeks]|The Rhinoconjunctivitis Quality-of-Life Questionnaire (RQLQ) has 28 questions and focusses on 7 domains that may be significantly impaired in participants with seasonal allergic rhinoconjunctivitis: sleep impairment, non-nasal symptoms, practical problems, nasal symptoms, eye symptoms, activity limitations, and emotional difficulty. The RQLQ score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains. RQLQ scores range from 0-6, with a higher score indicating more significant impairment.|assessed 6 weeks after initiation of treatment regimen|||units on a scale||Standard Error|Mean
754597|NCT00584987|Secondary|RQLQ Score [4 Weeks]|The Rhinoconjunctivitis Quality-of-Life Questionnaire (RQLQ) has 28 questions and focusses on 7 domains that may be significantly impaired in participants with seasonal allergic rhinoconjunctivitis: sleep impairment, non-nasal symptoms, practical problems, nasal symptoms, eye symptoms, activity limitations, and emotional difficulty. The RQLQ score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains. RQLQ scores range from 0-6, with a higher score indicating more significant impairment.|assessed 4 weeks after initiation of treatment regimen|||units on a scale||Standard Error|Mean
754598|NCT00584987|Secondary|RQLQ Score [2 Weeks]|The Rhinoconjunctivitis Quality-of-Life Questionnaire (RQLQ) has 28 questions and focusses on 7 domains that may be significantly impaired in participants with seasonal allergic rhinoconjunctivitis: sleep impairment, non-nasal symptoms, practical problems, nasal symptoms, eye symptoms, activity limitations, and emotional difficulty. The RQLQ score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains. RQLQ scores range from 0-6, with a higher score indicating more significant impairment.|assessed 2 weeks after initiation of treatment regimen|||units on a scale||Standard Error|Mean
754599|NCT00584987|Secondary|RQLQ Score [Baseline]|The Rhinoconjunctivitis Quality-of-Life Questionnaire (RQLQ) has 28 questions and focusses on 7 domains that may be significantly impaired in participants with seasonal allergic rhinoconjunctivitis: sleep impairment, non-nasal symptoms, practical problems, nasal symptoms, eye symptoms, activity limitations, and emotional difficulty. The RQLQ score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains. RQLQ scores range from 0-6, with a higher score indicating more significant impairment.|assessed at baseline|||units on a scale||Standard Error|Mean
754600|NCT00584987|Primary|Total Nasal Congestion Symptom Score|The severity of nasal congestion was recorded in the morning (reflective of symptoms overnight) and evening (reflective of daytime symptoms) on a 0 to 3 scale. The total nasal congestion symptom score was obtained by adding the symptoms obtained on all 28 days of treatment. Values for this outcome are in the range of 0 to 168 (i.e., 6 x 28). Congestion scores increase with congestion severity (i.e., higher numbers correspond to worse congestion).|28 days of treatment|||units on a scale||Full Range|Median
754601|NCT00585013|Secondary|Incidence of Methhemoglobin >5%, Gene Expression Profiles, and S100B.||48 hours|Data not collected for these assessments|||||
754602|NCT00585013|Primary|Ischemic Injury as Measured by Lactate Levels|Lactate levels correlate to ischemic injury. Higher values represent more injury.|48 hours|||mmol/L||Standard Deviation|Mean
754603|NCT00585013|Primary|Myocardial Function as Measured by B-type Natiuretic Peptide (BNP) Levels|BNP levels correlate to ventricular and myocardial performance, function, and strain. Higher values represent greater strain and decreased function.|48 hours|||pg/dL||Standard Deviation|Mean
754604|NCT00585013|Primary|Myocardial Injury|Troponin levels correlate with myocardial injury. Greater troponin levels represent greater myocardial injury|48 hours|||ng/mL||Standard Deviation|Mean
754605|NCT00585013|Primary|Serum Inflammatory Mediators Post CPB|Inflammation measured through the measurement inflammatory mediators, serum interleukin-6, serum interleukin-8, and tumor necrosis factor. Baseline (preoperative, 0h, 12h, 24h, and 48h.|48 hours|||ng/mL||Standard Deviation|Mean
754606|NCT00585039|Secondary|Clinical Asthma Score (CAS)|Change in clinical asthma score while in ED. 15 point clinical asthma score. Score ranges from 5 (no to mild respiratory distress) to a maximum of 15 (severe respiratory distress).|4 hours|analysis per protocol||units on a scale||95% Confidence Interval|Mean
754607|NCT00585039|Primary|Change in Forced Expiratory Volume in 1 Sec (FEV1) Measured in L/Sec||Baseline and 4 hours|Enrollment period ended prior to final goal sample size. ITT.||L/sec||95% Confidence Interval|Mean
754822|NCT00586521|Secondary|Physical Assessment Compared to On-demand Treatment as Determined by the Gilbert Score|Total score with a range of 0-100, evaluating ankle, knee and elbow, 0 indicates normal function, higher values indicate joint damage|Month 13 (end of prophylactic treatment) and Month 6 (end of on-demand treatment)|intent-to-treat||Gilbert score (0-100)||Standard Deviation|Mean
754608|NCT00585078|Secondary|Progression-Free Survival|Progression-free survival based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from treatment or death. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.|Disease evaluations occurred every two cycles (42 days ±2 days) on treatment. In this study cohort, participants were followed for progression up to 38 months.|The analysis dataset is comprised of response evaluable participants which required completion of two cycles of treatment.||months||95% Confidence Interval|Median
754609|NCT00585078|Secondary|Overall Survival|Overall survival is defined as the time from study entry to death or date last known alive and estimated using Kaplan-Meier (KM) methods.|Participants were followed long-term for survival every 3 months from the end of treatment until death or lost to follow-up. Median survival follow-up was 10.8 months (95% CI: 7.1-37.7) in this study cohort.|The analysis dataset is comprised of treated participants.||months||95% Confidence Interval|Median
754610|NCT00585078|Secondary|Best Response|Best response on treatment was based on RECIST 1.0 criteria: Complete Response (CR) is complete disappearance of all target lesions; Partial Response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. Both require confirmation no fewer than 4 weeks apart. CR/PR assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. Progressive disease (PD) is at least a 20% increase in the sum of longest diameter of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions. Stable disease is defined as any condition not meeting above criteria.|Response was assessed by computed tomography (CT) or magnetic resonance imaging (MRI) every two cycles (42 days ±2 days) on treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX.|The analysis dataset is comprised of response evaluable participants which required completion of two cycles of treatment.||participants|||Number
754611|NCT00585078|Primary|Response Rate|Response rate (RR) is defined as the proportion of participants achieving partial response (PR) or complete response (CR) based on RECIST 1.0 criteria on treatment. Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.|Response was assessed by computed tomography (CT) or magnetic resonance imaging (MRI) every two cycles (42 days ±2 days) on treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX.|The analysis dataset is comprised of response evaluable participants which required completion of two cycles of treatment.||proportion of participants||80% Confidence Interval|Number
754612|NCT00585104|Primary|Change in Left Ventricular End-diastolic Pressure (LVEDP) Using Pressure-volume Catheter.|Left ventricular end-diastolic pressure (LVEDP) recorded from CD Leycom ConductNT software analysis.|From baseline to 30-minutes after levosimendan started.|Ten patients were enrolled. Complete data was available in 6 patients. The primary endpoint was change in left ventricular end diastolic pressure (LVEDP) from baseline to 30-minutes after starting levosimendan. An Intent to Treat (ITT) analysis was performed.||mmHg||Standard Deviation|Mean
754613|NCT00578279|Primary|The Change in Mean Pain Scale Rating in Patients Following Treatment With 10mL or 20mL of Alcohol Injection|Pain will be assessed at baseline 24 hours after the procedure and weekly thereafter, until the subject reports no subjective pain relief from the procedure. Pain relief is defined as a decrease in 2 points on a 0-10 point pain rating scale. Zero is no pain and 10 is the worst pain.|baseline up to 1 year|||units on a scale||Standard Deviation|Mean
754614|NCT00578305|Secondary|Adverse Events (AEs), Laboratory Parameters, C-reactive Protein, ESR.||Throughout study||||||
754615|NCT00578305|Secondary|Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 24 and 52|The HAQ-DI assesses how well the patient is able to perform 8 activities: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. The patient answers 20 questions with 1 of 4 responses with the past week as the time frame: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The highest score for any question in a category determines the category score. The total score ranges from 0 (no disability) to 3 (completely disabled). A negative change score indicates improvement.|Baseline to Week 52|Intent-to-treat population: All randomized participants and received any part of an infusion of study medication during the main study.||Units on a scale||Standard Deviation|Mean
754616|NCT00578305|Secondary|Correlation of Magnetic Resonance Imaging Assessments and Clinical Outcome Measures|Correlation coefficients of magnetic resonance imaging erosion, synovitis, and osteitis scores and clinical outcome measures of swollen joint count (SJC), tender joint count (TJC), C-reactive protein level (CRP), erythrocyte sedimentation rate (ESR), a participant’s global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (GH), Disease Activity Score 28-C-reactive protein (DAS28-CRP), and Disease Activity Score 28-erythrocyte sedimentation rate (DAS28-ESR) are reported. Not all of these variables were specified as primary or secondary Outcome Measures in the study protocol and were not individually analyzed.|Baseline to Week 52|Intent-to-treat population: All randomized participants and received any part of an infusion of study medication during the main study.||Correlation coefficient|||Number
754641|NCT00578383|Primary|Mean Change in Hamilton Depression Rating Scale (HAM-D) (17 Item) in Subjects With Bipolar Depression|A multiple choice questionnaire used to rate depression severity. Mean change from pretreatment score. 17 items reflecting depression symptoms are scored on scale of severity; 9 items are scored 0 = Absent 1 = Trivial 2 = Mild 3 = Moderate 4 = Severe 8 items are scored 0 = Absent 1 = Mild 2 = Severe. Items are summed; minimum score is 0, maximum score is 52. Higher scores represent more severe depression.|Once just before and once just after treatment|Qualifying subjects who completed the the study with qualifying HAM-D scores and complete data.||units on a scale||Standard Error|Mean
754617|NCT00578305|Secondary|Percentage of Participants Achieving a Major Clinical Response at Week 52|A major clinical response was defined as an improvement of at least 70% in the American College of Rheumatology score from Baseline at Week 52. Improvement must be seen in tender and swollen joint counts (28 assessed joints) and in at least 3 of the following 5 parameters: Separate participant and physician assessments of participant disease activity in the previous 24 hours on a visual analog scale (VAS, the extreme left end of the line “no disease activity” [symptom-free and no arthritis symptoms] and the extreme right end “maximum disease activity”); participant assessment of pain in previous the 24 hours on a VAS (extreme left end of the line “no pain” and the extreme right end “unbearable pain”); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and C reactive protein level.|Baseline to Week 52|Intent-to-treat population: All randomized participants and received any part of an infusion of study medication during the main study.||Percentage of participants|||Number
754618|NCT00578305|Secondary|Percentage of Participants With an Improvement of at Least 20%, 50%, or 70% in the American College of Rheumatology (ACR) Score (ACR20/50/70) From Baseline at Weeks 24 and 52|Improvement must be seen in tender and swollen joint counts (28 assessed joints; Joints were evaluated and classified as swollen or not swollen and tender or not tender based on pressure and joint manipulation upon physical examination) and in at least 3|Baseline to Week 52|Intent-to-treat population: All randomized participants and received any part of an infusion of study medication during the main study.||Percentage of participants|||Number
754619|NCT00578305|Secondary|Percentage of Participants in Remission Response (Disease Activity Score 28 [DAS28] < 2.6) at Weeks 24 and 52|The percentage of participants in remission of their rheumatic arthritis at Weeks 24 and 52, as measured by a DAS28 score < 2.6, is reported. DAS28 is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(CRO)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints, GH = a participant’s global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]), and CRP = C-reactive protein level. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.|Baseline to Week 52|Intent-to-treat population: All randomized participants and received any part of an infusion of study medication during the main study.||Percentage of participants|||Number
754620|NCT00578305|Secondary|Percentage of Participants With Low Disease Activity (Disease Activity Score 28 [DAS28] ≤ 3.2) at Weeks 24 and 52|The percentage of participants who had low rheumatic arthritis disease activity at Weeks 24 and 52, as measured by a DAS28 score ≤ 3.2, is reported. DAS28 is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(CRO)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints, GH = a participant’s global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]), and CRP = C-reactive protein level. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.|Baseline to Week 52|Intent-to-treat population: All randomized participants and received any part of an infusion of study medication during the main study.||Percentage of participants|||Number
754621|NCT00578305|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Good, Moderate, or no Response at Weeks 24 and 52|Change of the DAS28 score from Baseline was used to determine the EULAR responses. For a post-Baseline score ≤ 3.2, a change from Baseline of < -1.2 was a good response, < -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-Baseline score > 3.2 to ≤ 5.1, a change from Baseline of < -0.6 was a moderate response and ≥ -0.6 was no response. For a post-Baseline score > 5.1, a change from Baseline < -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-Baseline scores > 3.2. DAS28=(0.56×√(TJC28))+(0.28×√(SJC28))+(0.7×log(CRP))+(0.014×GH), where TJC28=tender joint count (JC) and SJC28=swollen JC (28 joints), GH=a participant’s global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end=no disease activity, right end=maximum disease activity), and CRP=C-reactive protein level. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.|Baseline to Week 52|Intent-to-treat population: All randomized participants and received any part of an infusion of study medication during the main study.||Percentage of participants|||Number
754622|NCT00578305|Secondary|Change From Baseline in the Disease Activity Score 28 (DAS28) at Weeks 24 and 52|The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, C-reactive protein level (CRP), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(CRO)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints, GH = a participant’s global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]). The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A negative change score indicates improvement.|Baseline to Week 52|Intent-to-treat population: All randomized participants and received any part of an infusion of study medication during the main study.||Units on a scale||Standard Deviation|Mean
754623|NCT00578305|Secondary|Percentage of Participants With Improvement in Osteitis at Weeks 24 and 52|There were 2 definitions of improvement in osteitis. A participant met the criterion for definition 1 when there was a drop in the magnetic resonance imaging osteitis score from Baseline > 0.5. A participant met the criterion for definition 2 when there was a drop in the magnetic resonance imaging osteitis score from Baseline > than the smallest detectable change. The osteitis score was determined according to the Outcome Measures in Rheumatology (OMERACT) rheumatoid arthritis MRI (RAMRIS) scoring system in magnetic resonance images with and without gadolinium of 15 anatomical locations in each wrist and 10 locations in each hand in the hand and wrist with the most arthritic activity. If there was no difference in disease activity between the hands, the dominant hand was used. Images were assessed by 2 experienced blinded musculoskeletal radiologists.|Baseline to Week 52|Intent-to-treat population: All randomized participants and received any part of an infusion of study medication during the main study.||Percentage of participants|||Number
754624|NCT00578305|Secondary|Percentage of Participants With Improvement in Synovitis at Weeks 24 and 52|There were 2 definitions of improvement in synovitis. A participant met the criterion for definition 1 when there was a drop in the magnetic resonance imaging synovitis score from Baseline > 0.5. A participant met the criterion for definition 2 when there was a drop in the magnetic resonance imaging synovitis score from Baseline > than the smallest detectable change. The synovitis score was determined according to the Outcome Measures in Rheumatology (OMERACT) rheumatoid arthritis MRI (RAMRIS) scoring system in magnetic resonance images with and without gadolinium of 15 anatomical locations in each wrist and 10 locations in each hand in the hand and wrist with the most arthritic activity. If there was no difference in disease activity between the hands, the dominant hand was used. Images were assessed by 2 experienced blinded musculoskeletal radiologists.|Baseline to Week 52|Intent-to-treat population: All randomized participants and received any part of an infusion of study medication during the main study.||Percentage of participants|||Number
754625|NCT00578305|Secondary|Percentage of Participants With no Progression/no Worsening in Bone Erosion at Weeks 24 and 52|There were 2 definitions of no progression/no worsening in bone erosion. A participant met the criterion for definition 1 when there was a change in the magnetic resonance imaging erosion score ≤ 0. A participant met the criteria for definition 2 when there was either (1) no change from Baseline in the MRI erosion score, (2) an increase in erosion score and the size of the increase in score was smaller than the smallest detectable change, or (3) a drop in the erosion score. The erosion score was determined according to the Outcome Measures in Rheumatology (OMERACT) rheumatoid arthritis MRI scoring (RAMRIS) system in magnetic resonance images with and without gadolinium of 15 anatomical locations in each wrist and 10 locations in each hand in the hand and wrist with the most arthritic activity. If there was no difference in disease activity between the hands, the dominant hand was used. Images were assessed by 2 experienced blinded musculoskeletal radiologists.|Baseline to Week 52|Intent-to-treat population: All randomized participants and received any part of an infusion of study medication during the main study.||Percentage of participants|||Number
754626|NCT00578305|Secondary|Percentage of Participants With no Newly Eroded Joints at Weeks 24 and 52|No newly eroded joints was defined as no new erosions in joints which were scored 0 at baseline. The erosion score was determined according to the Outcome Measures in Rheumatology (OMERACT) rheumatoid arthritis MRI scoring (RAMRIS) system in magnetic resonance images with and without gadolinium of 15 anatomical locations in each wrist and 10 locations in each hand in the hand and wrist with the most arthritic activity. If there was no difference in disease activity between the hands, the dominant hand was used. Images were assessed by 2 experienced blinded musculoskeletal radiologists. Each location was scored in 0.5 increments from 0 to 10 with each integer unit increment representing a 10% loss of articular bone using the following scale. 0.0=normal, no erosion; 0.5=1-5% erosion; 1.0=6-10% erosion; 1.5=11-15% erosion; 2.0=16-20% erosion; etc, up to 10.0=96-100% erosion.|Baseline to Week 52|Intent-to-treat population: All randomized participants and received any part of an infusion of study medication during the main study.||Percentage of participants|||Number
754627|NCT00578305|Secondary|Change in Magnetic Resonance Imaging (MRI) Osteitis Score From Baseline to Weeks 12, 24, and Week 52|The osteitis score was determined according to the Outcome Measures in Rheumatology (OMERACT) rheumatoid arthritis MRI scoring (RAMRIS) system in magnetic resonance images of 15 anatomical locations in each wrist and 10 locations in each hand in the hand and wrist with the most arthritic activity. If there was no difference in disease activity between the hands, the dominant hand was used. Each location was scored in 0.5 increments from 0 to 3 with each integer unit increment representing a 33% increase in the volume of the peripheral 1 cm of original (eroded + residual) articular bone using the following scale: 0.0=normal, no osteitis; 0.5=1-17% involvement of original articular bone; 1.0=18-33%; 1.5=34-50%; 2.0=51-67%; 2.5=68-83%; 3.0=84-100% involvement of original articular bone. The individual scores were summed and normalized to a range of 0 to 100 with a higher score indicating more synovitis. A negative change score indicates improvement.|Baseline to Week 52|Intent-to-treat population: All randomized participants and received any part of an infusion of study medication during the main study.||Units on a scale||Standard Deviation|Mean
754628|NCT00578305|Secondary|Change in Magnetic Resonance Imaging (MRI) Synovitis Score From Baseline to Weeks 12, 24, and Week 52|The synovitis score was determined according to the Outcome Measures in Rheumatology (OMERACT) rheumatoid arthritis MRI scoring (RAMRIS) system in magnetic resonance images of 3 wrist regions and 5 metacarpophalangeal joints in the hand and wrist with the most arthritic activity. If there was no difference in disease activity between the hands, the dominant hand was used. Images were assessed by 2 experienced blinded musculoskeletal radiologists. Each location was scored in 0.5 increments from 0 to 3 with each integer unit increment representing a 33% enhancement of the maximum volume of enhancing tissue in the synovial compartment using the following scale: 0.0=normal, no synovitis; 0.5=1-17% estimated volume of enhancement; 1.0=18-33%; 1.5=34-50%; 2.0=51-67%; 2.5=68-83%; 3.0=84-100% estimated volume of enhancement. The individual scores were summed and normalized to a range of 0 to 100 with a higher score indicating more synovitis. A negative change score indicates improvement.|Baseline to Week 52|Intent-to-treat population: All randomized participants and received any part of an infusion of study medication during the main study.||Units on a scale||Standard Deviation|Mean
754629|NCT00578305|Secondary|Change in Magnetic Resonance Imaging (MRI) Erosion Score From Baseline to Weeks 12 and 52|The erosion score was determined according to the Outcome Measures in Rheumatology (OMERACT) rheumatoid arthritis MRI scoring (RAMRIS) system in magnetic resonance images with and without gadolinium of 15 anatomical locations in each wrist and 10 locations in each hand in the hand and wrist with the most arthritic activity. If there was no difference in disease activity between the hands, the dominant hand was used. Images were assessed by 2 experienced blinded musculoskeletal radiologists. Each location was scored in 0.5 increments from 0 to 10 with each integer unit increment representing a 10% loss of articular bone using the following scale. 0.0=normal, no erosion; 0.5=1-5% erosion; 1.0=6-10% erosion; 1.5=11-15% erosion; 2.0=16-20% erosion; etc, up to 10.0=96-100% erosion. The individual scores were summed and normalized to a range of 0 to 100 with a higher score indicating more erosion. A negative change score indicates improvement.|Baseline to Week 52|Intent-to-treat population: All randomized participants and received any part of an infusion of study medication during the main study.||Units on a scale||Standard Deviation|Mean
754823|NCT00586521|Secondary|Number of All Bleeds|Mean number of all bleeds during Months 8-13 (prophylactic) compared to mean number of all bleeds during Months 1-6 (on-demand)|Months 1-6 (on-demand treatment) and 8-13 (prophylactic treatment)|intention-to-treat||All bleeds||Standard Deviation|Mean
754630|NCT00578305|Primary|Change in Magnetic Resonance Imaging (MRI) Erosion Score From Baseline to Week 24|The erosion score was determined according to the Outcome Measures in Rheumatology (OMERACT) rheumatoid arthritis MRI scoring (RAMRIS) system in magnetic resonance images with and without gadolinium of 15 anatomical locations in each wrist and 10 locations in each hand in the hand and wrist with the most arthritic activity. If there was no difference in disease activity between the hands, the dominant hand was used. Images were assessed by 2 experienced blinded musculoskeletal radiologists. Each location was scored in 0.5 increments from 0 to 10 with each integer unit increment representing a 10% loss of articular bone using the following scale. 0.0=normal, no erosion; 0.5=1-5% erosion; 1.0=6-10% erosion; 1.5=11-15% erosion; 2.0=16-20% erosion; etc, up to 10.0=96-100% erosion. The individual scores were summed and normalized to a range of 0 to 100 with a higher score indicating more erosion. A negative change score indicates improvement.|Baseline to Week 24|Intent-to-treat population: All randomized participants and received any part of an infusion of study medication during the main study.||Units on a scale||Standard Deviation|Mean
754631|NCT00578318|Primary|Attendance at First Depression Treatment Appointment|Patients were randomized to the intervention or a delayed control group. The primary outcome was bifurcated as yes or no to specify whether or not the patient attended the first available depression treatment appointment scheduled after he/she completed the AAKOMA protocol. The average time to attendance at the first session was approximately 3-4 weeks and during this intermediate time between completion of the protocol and initiation of treatment all patients were followed by study staff).|Post completion of 2 session Motivational Interviewing (MI) intervention (approximately 3-4 weeks on average during which time study staff followed all patients)|||participants|||Number
754634|NCT00578383|Secondary|Positive and Negative Affect Schedule (PANAS) Negative Score in Subjects With Major Depressive Disorder|20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely. Positive and Negative scores are calculated and reported separately and range from 10-50. Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect.|once pre and once post LFMS treatment|Qualifying subjects who completed the the study with qualifying HAM-D scores and complete data.||units on a scale||Standard Error|Mean
754635|NCT00578383|Secondary|Positive and Negative Affect Schedule (PANAS) Negative Score in Subjects With Bipolar Depression|20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely. Positive and Negative scores are calculated and reported separately and range from 10-50. Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect.|once pre and once post LFMS treatment|Qualifying subjects who completed the the study with qualifying HAM-D scores and complete data.||units on a scale||Standard Error|Mean
754636|NCT00578383|Secondary|Positive and Negative Affect Schedule (PANAS) Positive Score in Subjects With Major Depressive Disorder|20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely. Positive and Negative scores are calculated and reported separately and range from 10-50. Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect.|Once just before and once just after treatment|Qualifying subjects who completed the the study with qualifying HAM-D scores and complete data.||units on a scale||Standard Error|Mean
754637|NCT00578383|Secondary|Positive and Negative Affect Schedule (PANAS) Positive Score in Subjects With Bipolar Depression.|20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely. Positive and Negative scores are calculated and reported separately and range from 10-50. Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect.|Once just before and once just after treatment|Qualifying subjects who completed the the study with qualifying HAM-D scores and complete data.||units on a scale||Standard Error|Mean
754638|NCT00578383|Primary|Visual Analog Scale (VAS) in Subjects With Major Depressive Disorder|Eleven point Likert scales indicating immediate depression state. Mean change from pretreatment score. Participant marks an 'X' on a numbered line anchored by 0 = no depression and 10 = most depressed ever been.|Once just before and once just after treatment|Qualifying subjects who completed the the study with qualifying HAM-D scores and complete data.||units on a scale||Standard Error|Mean
754639|NCT00578383|Primary|Visual Analog Scale (VAS) in Subjects With Bipolar Depression|Eleven point Likert scales indicating immediate depression state. Mean change from pretreatment score. Participant marks an 'X' on a numbered line anchored by 0 = no depression and 10 = most depressed ever been.|Once just before and once just after treatment|Qualifying subjects who completed the the study with qualifying HAM-D scores and complete data.||units on a scale||Standard Error|Mean
754640|NCT00578383|Primary|Mean Change in Hamilton Depression Depression Rating Scale (HAM-D) (17 Item) in Subjects With Major Depressive Disorder|A multiple choice questionnaire used to rate depression severity. Mean change from pretreatment score. 17 items reflecting depression symptoms are scored on scale of severity; 9 items are scored 0 = Absent 1 = Trivial 2 = Mild 3 = Moderate 4 = Severe 8 items are scored 0 = Absent 1 = Mild 2 = Severe. Items are summed; minimum score is 0, maximum score is 52. Higher scores represent more severe depression.|Once just before and once just after treatment|Qualifying subjects who completed the the study with qualifying HAM-D scores and complete data.||units on a scale||Standard Error|Mean
754824|NCT00586521|Primary|Number of Joint Bleeds|Number of joint bleeds during Months 8-13 compared to number of joint bleeds during Months 1-6|Months 1-6 (on-demand treatment) and 8-13 (prophylactic treatment)|intent-to-treat population||Number of joint bleeds||Standard Deviation|Mean
754642|NCT00578383|Secondary|Positive and Negative Affect Schedule (PANAS) Negative Score: Combined Diagnostic Group.|20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely. Positive and Negative scores are calculated and reported separately and range from 10-50. Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect.|once pre and once post LFMS treatment|Qualifying subjects who completed the the study with qualifying HAM-D scores.||units on a scale||Standard Error|Mean
754643|NCT00578383|Secondary|Positive and Negative Affect Schedule (PANAS) Positive Score: Combined Diagnostic Group.|20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely. Positive and Negative scores are calculated and reported separately and range from 10-50. Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect.|Once just before and once just after treatment|Qualifying subjects who completed the the study with qualifying HAM-D scores.||units on a scale||Standard Error|Mean
754644|NCT00578383|Secondary|Visual Analog Scale (VAS): Combined Diagnostic Groups.|Eleven point Likert scales indicating immediate depression state. Mean change from pretreatment score. Participant marks an 'X' on a numbered line anchored by 0 = no depression and 10 = most depressed ever been.|Once just before and once just after treatment|Qualifying subjects who completed the the study with qualifying HAM-D scores.||units on a scale||Standard Error|Mean
754645|NCT00578383|Secondary|Mean Change in Hamilton Depression Rating Scale (HAM-D) (17 Item): Combined Diagnostic Groups.|A multiple choice questionnaire used to rate depression severity. Mean change from pretreatment score. 17 items reflecting depression symptoms are scored on scale of severity; 9 items are scored 0 = Absent 1 = Trivial 2 = Mild 3 = Moderate 4 = Severe 8 items are scored 0 = Absent 1 = Mild 2 = Severe. Items are summed; minimum score is 0, maximum score is 52. Higher scores represent more severe depression.|Once just before and once just after treatment|Qualifying subjects who completed the the study with qualifying HAM-D scores and complete data.||units on a scale||Standard Error|Mean
761132|NCT00631488|Primary|Change From Baseline (BL) to Week 4 in 24-hour Weighted Mean Glucose (WMG) Levels||BL, 4 weeks (end of double-blind treatment period)|Full Analysis Set Population||mg/dL||Standard Error|Least Squares Mean
754657|NCT00578461|Primary|Median Percentage of Treg Cells at 1 Year Post Transplant|The investigative intent is to determine the changes in numbers and function of the regulatory cell population using the best methods to measure this cell population. The frequency of T cells will be summarized at baseline and each time point of follow-up.|1 Year|Only 20 of the 26 patients enrolled were included in this analysis as only 20 patients have Treg values at 1 year.||percentage of total CD4+ cells||Inter-Quartile Range|Median
754658|NCT00578539|Primary|Median Percentage of Treg Cells at 1 Year Post Transplant|To define the biologic recovery and behavior of T regulatory cells for patients undergoing stem cell transplantation as specified in this protocol|1 year|Only 13 of the 24 patients enrolled were included in this analysis as only 13 patients have Treg values at 1 year.||percentage of total CD4+ cells||Inter-Quartile Range|Median
754659|NCT00578552|Primary|Biochemically Confirmed 7-day Point Prevalence Abstinence From Tobacco|Point prevalence tobacco abstinence was adjudicated if the following conditions were met: (a) self-reported tobacco abstinence for the previous 7 days with a negative response to the question “Have you used any type of tobacco, even a puff, in the past 7 days?” and (b) Expired Carbon Monoxide equal or less then 8 parts per million.|12 weeks following start of medication|||participants|||Number
754719|NCT00585312|Primary|Time to Disease Progression|"Time to disease progression was defined as the time from randomization to the earliest occurrence of one or more of the following events:
Appearance of ≥20 polyps (>2 mm in size) at any colonoscopy during the study (Polyps); or
Diagnosis of colorectal malignancy (ColMal)."|5 years|ITT population (N: 106) consisted of all participants who were randomized and assigned to treatment. Primary outcome measure was met by 7 (Polyp:7,ColMal:0) participants in the Celecoxib group and 13 (13,0) in the placebo group. Study was early terminated due to low enrollment and lower than expected endpoint rate. No analysis was performed.||years||Standard Deviation|Mean
754660|NCT00578565|Secondary|Percentage of Change in Health Associated Quality of Life From Baseline to 48 Weeks|The percentage change from baseline to week 48 in a participant's perception of the impact of health on his or her quality of life was collected on the Health Assessment Questionnaire (HAQ). The HAQ measures a person's ability to function with arthritis. The questionnaire is divided into 8 categories (Dressing and Grooming, Arising, Eating, Walking, Hygiene, Reach, Grip and Activities) which include several questions for each category. The category score is determined by the highest score of the set of questions for each category. The disability score is determined by adding the scores for all categories and dividing by 8. The disability scale ranges from 0 (best - without any difficulty) to 3 (worst - unable to do much).|baseline, 48 weeks|Three participants of the 10 enrolled withdrew or died before the end of the study.||percentage of change||Full Range|Mean
754661|NCT00578565|Primary|Change in Forced Vital Capacity (FVC) From Baseline to 48 Weeks|FVC is one measure of pulmonary function. For FVC, worsening was defined as decrease of at least 10% and improvement was defined as increase of at least 10%.|baseline, 48 weeks|Three participants of the 10 enrolled withdrew or died before the end of the study.||participants|||Number
754662|NCT00578565|Secondary|Change in RA Disease Activity From Baseline to 48 Weeks Using the DAS28 Score.|"The DAS28 score is a measure of RA disease activity calculated using variables such as swollen joint count, the Erythrocyte Sedimentation Rate (ESR) and patient reported assessment of health.
Using this data, the DAS28 calculation provides a number on a scale from 0-10 indicating the current activity of a patient's RA. A DAS28 score above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity. Remission is achieved by a DAS28 score lower than 2.6."|baseline, 48 weeks|Three participants of the 10 enrolled withdrew or died before the end of the study.||percentage of change||Full Range|Mean
754663|NCT00578565|Secondary|Assessment of RA Disease Activity Scores as Measured by the DAS28 Score at Baseline and 48 Weeks|"The DAS28 score is a measure of RA disease activity calculated using variables such as swollen joint count, the Erythrocyte Sedimentation Rate (ESR) and patient reported assessment of health.
Using this data, the DAS28 calculation provides a number on a scale from 0-10 indicating the current activity of a patient's RA. A DAS28 score above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity. Remission is achieved by a DAS28 score lower than 2.6."|baseline, 48 weeks|Three participants of the 10 enrolled withdrew or died before the end of the study.||units on a scale||Full Range|Mean
754664|NCT00578565|Secondary|Change in Lung Fibrosis Score as Observed on High Resolution Computerized Tomography (HRCT) Scans, From Baseline to 48 Weeks|Three serial HRCT scans of each patient were scored independently and simultaneously by two core radiologists, who were blinded to the sequence in which three scans were obtained (at screening, 24 and 48 weeks). The HRCT scoring sheet scored different domains of abnormality such as, linear opacities, consolidation, ground-glass density, etc. Radiographers reported composite impression based on scoring according to worsening, no worsening or improvement of relevant domains.|baseline, 48 weeks|Three participants of the 10 enrolled withdrew or died before the end of the study.||participants|||Number
754665|NCT00578565|Primary|Change in Diffusion Capacity for Carbon Monoxide (DLco) From Baseline to 48 Weeks|DLco is one pulmonary function measure. For DLco, worsening was defined as decrease of at least 15% and improvement was defined as increase of at least 15%.|baseline, 48 weeks|Three participants of the 10 enrolled withdrew or died before the end of the study.||participants|||Number
754666|NCT00578617|Primary|Number of Participants Experiencing Recurrence of Atrial Fibrillation by One Year Follow-up|Documentation of atrial fibrillation using a cardiac event recorder|12 months after intervention|||participants|||Number
754667|NCT00578734|Secondary|Ventilator-free Days; Duration of Days on Oxygen, Intensive Care Unit (ICU) Stay, and Hospitalization Through 14 Days||Up to 14 days|The sample size calculation was based on historical data and expected treatment effect. The primary efficacy analysis was for the intent-to-treat population, defined as all randomized subjects (N=165). A supportive population (N=134) of subjects without a major protocol violation that could impact efficacy was also used for efficacy analyses.||days||95% Confidence Interval|Least Squares Mean
754668|NCT00578734|Primary|Duration of Mechanical Ventilation Through 14 Days|Duration of mechanical ventilation (MV) from baseline to successful extubation (not receiving MV for at least 24 hours) through a maximum of 14 days.|Up to 14 Days|The sample size calculation was based on historical data and expected treatment effect. The primary efficacy analysis was for the intent-to-treat population, defined as all randomized subjects (N=165). A supportive population (N=134) of subjects without a major protocol violation that could impact efficacy was also used for efficacy analyses.||days||95% Confidence Interval|Least Squares Mean
754669|NCT00578786|Primary|Serum Aminotransferases Relative to the Upper Limit of the Normal Range (ULN)|The number of participants with serum alanine aminotransferase (ALT) and serum aspartate aminotransferase (AST) falling into the following categories: >3.0 and </= 5.0 x ULN, >5.0 and </= 8.0 x ULN, and >8.0 x ULN. Includes the highest value per participant across all visits as well as values from early termination visits.|Baseline to Week 295|Safety Analysis Set: Includes all participants who received at least 1 blinded dose of AMB in one of the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study.||participants|||Number
754670|NCT00578786|Secondary|Long-term Survival|Long-term survival was defined as the time from initiation of active treatment to death. Results are presented as the Kaplan-Meier estimate (% probability) of survival after a given time.|Baseline to Year 4|All assessments of efficacy were performed using the randomized analysis set, such that subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study.||percent probability (KM estimate)||95% Confidence Interval|Number
754671|NCT00578786|Secondary|Percentage of Participants With Failure-Free Treatment Status|Treatment failure was defined as the time from randomization to ambrisentan therapy to the first occurrence of death, lung transplantation, addition of approved prostanoid therapy, study withdrawal due to the addition of other clinically approved PAH therapeutics, or study withdrawal due to 2 or more early escape criteria (for subjects randomized to ambrisentan in NCT00423748 or NCT00423202). Results are presented as the Kaplan-Meier estimate (% probability) of not having treatment failure after a given time.|Baseline to Year 4|All assessments of efficacy were performed using the randomized analysis set, such that subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study.||percent probability (KM estimate)||95% Confidence Interval|Number
754672|NCT00578786|Secondary|Percentage of Participants With No Clinical Worsening of PAH|Clinical worsening of PAH was defined as the time from randomization to ambrisentan therapy to the first occurrence of death, lung transplantation, hospitalization for PAH, atrial septostomy, addition of approved prostanoid therapy, study withdrawal due to the addition of other clinically approved PAH therapeutics, or study withdrawal due to 2 or more early escape criteria (for subjects randomized to AMB in NCT00423748 or NCT00423202). Results are presented as the Kaplan-Meier estimate (% probability) of not having clinical worsening after a given time.|Baseline to Year 3|All assessments of efficacy were performed using the randomized analysis set, such that subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study.||percent probability (KM estimate)||95% Confidence Interval|Number
754673|NCT00578786|Secondary|Change From Baseline to Week 36 in SF-36 Health Survey Scales for the Combined Ambrisentan Group|The 8 scales of the SF-36 Health Survey measured included physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health, and the summary measures included physical health and mental health. Scores for each scale are transformed and the transformed scores range from 0 (worst health) to 100 (best health). The scores are then standardized with the 1998 General US population mean and SD. Finally, the scores are transformed to the norm-based scoring with a mean of 50 and SD of 10.|Baseline to Week 36|All participants were combined into one group for this analysis (all doses) and an observed-case approach was used.||units on a scale||Standard Deviation|Mean
754674|NCT00578786|Secondary|Change From Baseline to Week 24 in SF-36 Health Survey Scales for the Combined Ambrisentan Group|The 8 scales of the SF-36 Health Survey measured included physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health, and the summary measures included physical health and mental health. Scores for each scale are transformed and the transformed scores range from 0 (worst health) to 100 (best health). The scores are then standardized with the 1998 General US population mean and SD. Finally, the scores are transformed to the norm-based scoring with a mean of 50 and SD of 10.|Baseline to Week 24|All participants were combined into one group for this analysis (all doses) and an observed-case approach was used.||units on a scale||Standard Deviation|Mean
754675|NCT00578786|Secondary|Change From Baseline to Week 12 in SF-36 Health Survey Scales for the Combined Ambrisentan Group|The 8 scales of the SF-36 Health Survey measured included physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health, and the summary measures included physical health and mental health. Scores for each scale are transformed and the transformed scores range from 0 (worst health) to 100 (best health). The scores are then standardized with the 1998 General US population mean and SD. Finally, the scores are transformed to the norm-based scoring with a mean of 50 and SD of 10.|Baseline to Week 12|All participants were combined into one group for this analysis (all doses) and an observed-case approach was used.||units on a scale||Standard Deviation|Mean
754676|NCT00578786|Secondary|Baseline SF-36 Health Survey Scales for the Combined Ambrisentan Group|The 8 scales of the SF-36 Health Survey measured included physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health, and the summary measures included physical health and mental health. Scores for each scale are transformed and the transformed scores range from 0 (worst health) to 100 (best health). The scores are then standardized with the 1998 General United States (US) population mean and standard deviation (SD). Finally, the scores are transformed to the norm-based scoring with a mean of 50 and SD of 10.|Baseline|All participants were combined into one group for this analysis (all doses) and an observed-case approach was used.||units on a scale||Standard Deviation|Mean
754677|NCT00578786|Secondary|Change From Baseline to Year 3 in World Health Organization (WHO) Functional Class|WHO Classes: I) pulmonary hypertension (PH); ordinary physical activity not limited or causes increased dyspnea, fatigue, chest pain, or presyncope. II) PH; ordinary physical activity mildly limited and causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. III) PH; physical activity markedly limited and less than ordinary physical activity causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. IV) PH; physical activity causes symptoms; signs of right heart failure; dyspnea/fatigue possible at rest.|Baseline to Year 3|All assessments of efficacy were performed using the randomized analysis set; subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the extension study. Missing values were imputed using LOCF based on post-baseline observations.||participants|||Number
754678|NCT00578786|Secondary|Change From Baseline to Year 2 in World Health Organization (WHO) Functional Class|WHO Classes: I) pulmonary hypertension (PH); ordinary physical activity not limited or causes increased dyspnea, fatigue, chest pain, or presyncope. II) PH; ordinary physical activity mildly limited and causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. III) PH; physical activity markedly limited and less than ordinary physical activity causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. IV) PH; physical activity causes symptoms; signs of right heart failure; dyspnea/fatigue possible at rest.|Baseline to Year 2|All assessments of efficacy were performed using the randomized analysis set; subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in extension study. Missing values were imputed using LOCF based on post-baseline observations.||participants|||Number
754679|NCT00578786|Secondary|Change From Baseline to Year 1 in World Health Organization (WHO) Functional Class|WHO Classes: I) pulmonary hypertension (PH); ordinary physical activity not limited or causes increased dyspnea, fatigue, chest pain, or presyncope. II) PH; ordinary physical activity mildly limited and causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. III) PH; physical activity markedly limited and less than ordinary physical activity causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. IV) PH; physical activity causes symptoms; signs of right heart failure; dyspnea/fatigue possible at rest.|Baseline to Year 1|All assessments of efficacy were performed using the randomized analysis set; subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in extension study. Missing values imputed using LOCF based on post-baseline observations.||participants|||Number
755321|NCT00593606|Primary|Change in Percentage of Lymphocytes in White Blood Cell Count|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||Percentage of white blood cell count||Standard Deviation|Mean
754680|NCT00578786|Secondary|Baseline World Health Organization (WHO) Functional Class|WHO Classes: I) pulmonary hypertension (PH); ordinary physical activity not limited or causes increased dyspnea, fatigue, chest pain, or presyncope. II) PH; ordinary physical activity mildly limited and causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. III) PH; physical activity markedly limited and less than ordinary physical activity causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. IV) PH; physical activity causes symptoms; signs of right heart failure; dyspnea/fatigue possible at rest.|Baseline|All assessments of efficacy were performed using the randomized analysis set, such that subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study.||participants|||Number
754681|NCT00578786|Secondary|Change From Baseline to Year 3 in Borg Dyspnea Index|Borg Dyspnea Index is a measure of perceived shortness of breath: 0 units on a scale (none) to 10 units on a scale (maximum breathlessness). Baseline (BL) values from the screening/randomization visit of the 2 prior studies defined the BL of this long-term analysis for those receiving AMB in the prior studies. The Screening/Randomization Visit of the present study was the BL for subjects receiving placebo in the prior studies.|Baseline to Year 3|All assessments of efficacy were performed using the randomized analysis set; subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the extension study. The LOCF method of imputation was used; only postbaseline observations were carried forward.||units on a scale||Standard Deviation|Mean
754682|NCT00578786|Secondary|Change From Baseline to Year 2 in Borg Dyspnea Index|Borg Dyspnea Index is a measure of perceived shortness of breath: 0 units on a scale (none) to 10 units on a scale (maximum breathlessness). Baseline (BL) values from the screening/randomization visit of the 2 prior studies defined the BL of this long-term analysis for those receiving AMB in the prior studies. The Screening/Randomization Visit of the present study was the BL for subjects receiving placebo in the prior studies.|Baseline to Year 2|All assessments of efficacy were performed using the randomized analysis set; subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the extension study. The LOCF method of imputation was used; only postbaseline observations were carried forward.||units on a scale||Standard Deviation|Mean
754683|NCT00578786|Secondary|Change From Baseline to Year 1 in Borg Dyspnea Index|Borg Dyspnea Index is a measure of perceived shortness of breath: 0 units on a scale (none) to 10 units on a scale (maximum breathlessness). Baseline (BL) values from the screening/randomization visit of the 2 prior studies defined the BL of this long-term analysis for those receiving ambrisentan in the prior studies. The Screening/Randomization Visit of the present study was the BL for subjects receiving placebo in the prior studies.|Baseline to Year 1|All assessments of efficacy were performed using the randomized analysis set; subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the extension study. The LOCF method of imputation was used; only postbaseline observations were carried forward.||units on a scale||Standard Deviation|Mean
754684|NCT00578786|Secondary|Baseline Borg Dyspnea Index|Borg Dyspnea Index is a measure of perceived shortness of breath: 0 units on a scale (none) to 10 units on a scale (maximum breathlessness).|Baseline|All assessments of efficacy were performed using the randomized analysis set, such that subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study.||units on a scale||Standard Deviation|Mean
754685|NCT00578786|Secondary|Change From Baseline to Year 3 in Exercise Capacity as Measured by the 6-Minute Walk Distance Test|Thoracic Society guidelines (ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med 2002; 166(1):111-117.). The last-observation-carried-forward (LOCF) imputation method was used. Baseline (BL) values from the screening/randomization visit of the 2 prior studies defined the BL of this long-term analysis for those receiving AMB in the prior studies. The Screening/Randomization Visit of the present study was the BL for subjects receiving placebo in the prior studies.|Baseline to Year 3|All assessments of efficacy were performed using the randomized analysis set; subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the extension study. The LOCF method of imputation was used; only postbaseline observations were carried forward.||Meters||Standard Deviation|Mean
754686|NCT00578786|Secondary|Change From Baseline to Year 2 in Exercise Capacity as Measured by the 6-Minute Walk Distance Test|The 6-minute walk distance (6MWD) test was conducted according to the American Thoracic Society guidelines (ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med 2002; 166(1):111-117.). The last-observation-carried-forward (LOCF) imputation method was used. Baseline (BL) values from the screening/randomization visit of the 2 prior studies defined the BL of this long-term analysis for those receiving AMB in the prior studies. The Screening/Randomization Visit of the present study was the BL for subjects receiving placebo in the prior studies.|Baseline to Year 2|All assessments of efficacy were performed using the randomized analysis set; subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the extension study. The LOCF method of imputation was used; only postbaseline observations were carried forward.||Meters||Standard Deviation|Mean
754687|NCT00578786|Secondary|Change From Baseline to Week 48 (Year 1) in Exercise Capacity as Measured by the 6-Minute Walk Distance Test|The 6-minute walk distance (6MWD) test was conducted according to the American Thoracic Society guidelines (ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med 2002; 166(1):111-117.). The last-observation-carried-forward (LOCF) imputation method was used. Baseline (BL) values from the screening/randomization visit of the 2 prior studies defined the BL of this long-term analysis for those receiving AMB in the prior studies. The Screening/Randomization Visit of the present study was the BL for subjects receiving placebo in the prior studies.|Baseline to Week 48|All assessments of efficacy were performed using the randomized analysis set; subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the extension study. The LOCF method of imputation was used; only postbaseline observations were carried forward.||Meters||Standard Deviation|Mean
755322|NCT00593606|Primary|Change in Hemoglobin|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||g/l||Standard Deviation|Mean
754688|NCT00578786|Secondary|Change From Baseline to Week 24 in Exercise Capacity as Measured by the 6-Minute Walk Distance Test|The 6-minute walk distance (6MWD) test was conducted according to the American Thoracic Society guidelines (ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med 2002; 166(1):111-117.). Missing values were imputed using LOCF method based on post-baseline observations. Baseline (BL) values from the screening/randomization visit of the 2 prior studies defined the BL of this long-term analysis for those receiving ambrisentan in the prior studies. The Screening/Randomization Visit of the present study was the BL for subjects receiving placebo in the prior studies.|Baseline to Week 24|All assessments of efficacy were performed using the randomized analysis set; subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the extension study. The LOCF method of imputation was used; only postbaseline observations were carried forward.||Meters||Standard Deviation|Mean
754689|NCT00578786|Primary|Frequently Reported (15% or More Overall) Adverse Events by Severity|The primary endpoint of this study is the incidence and severity of adverse events associated with long-term exposure to AMB in participants with PAH. The most frequently occurring adverse events (occurring in 15% or more of the participants in the combined group) are presented, by severity, that began after entering this extension study. Adverse events that were serious are included. Adverse events are coded according to the Medical Dictionary for Regulatory Activities (MedDRA) Version 6.1 and are presented by MedDRA preferred term. Severity was graded as follows: mild (AE did not interfere with routine activities; subject may have experienced slight discomfort), moderate (AE interfered with routine activities; subject may have experienced significant discomfort), and severe (AE made it impossible to perform routine activities; subject may have experienced intolerable discomfort or pain).|Baseline to Week 295|Safety Analysis Set: Includes all participants who received at least 1 dose of AMB in one of the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Treatment group assignments for the safety analysis set were based upon the highest dose of AMB received at any time during the parent or extension studies.||participants|||Number
754690|NCT00578786|Secondary|Baseline Exercise Capacity as Measured by the 6-Minute Walk Distance Test|The 6-minute walk distance (6MWD) test was conducted according to the American Thoracic Society guidelines (ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med 2002; 166(1):111-117.).|Baseline|All assessments of efficacy were performed using the randomized analysis set; subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the extension study. The LOCF method of imputation was used; only postbaseline observations were carried forward.||Meters||Standard Deviation|Mean
754691|NCT00578812|Secondary|Flexion/Extension Range of Motion at the Operative Level|Mean flexion/extension range of motion at operative level at 24 months. The operative level is defined as the cervical spinal level at which the surgical procedure was performed.|24 Months|Per Protocol||degrees||Standard Deviation|Mean
754692|NCT00578812|Secondary|Nurick's Classification of Disability (Myelopathy)|Maintenance or improvement in Nurick's Classification from baseline to 24 months. Nurick’s classification is a six-point scale, graded 0 to 5. A grade of 0 indicates no symptoms at all, while a grade of 5 is a bed or chair-bound patient. A patient “maintained” if their Nurick classification grade remained the same or “improved” if it decreased from baseline to 24 months.|24 Months|Per protocol with extended windows||participants|||Number
754693|NCT00578812|Secondary|Patient Satisfaction|Mean Patient Satisfaction at 24 months on a 0-100 Visual Analog Scale (higher value is better).|24 Months|Per protocol||mm||Standard Deviation|Mean
754694|NCT00578812|Secondary|Dysphagia for Swallowing|Mean dysphagia for swallowing at 24 months on a 0-100mm Visual Analog Scale (lower value is better).|24 Months|Per protocol||mm||Standard Deviation|Mean
754695|NCT00578812|Secondary|Mean SF-36 Mental Component Summary (MCS)|Mean SF-36 MCS at 24 months on a 0-100 scale (lower value is better).|24 Months|Per Protocol||units on a scale||Standard Deviation|Mean
754696|NCT00578812|Secondary|Clinically Significant Improvement on SF-36 Mental Component Summary (MCS)|Improvement of ≥15% on the SF-36 MCS at 24 months compared to baseline.|24 Months|Per Protocol||participants|||Number
754697|NCT00578812|Secondary|Mean SF-36 Physical Component Summary (PCS)|Mean SF-36 PCS at 24 months on a 0-100 scale (lower value is better).|24 Months|Per protocol||units on a scale||Standard Deviation|Mean
754698|NCT00578812|Secondary|Clinically Significant Improvement on SF-36 Physical Component Summary (PCS)|Improvement of ≥15% on SF-36 PCS at 24 months compared to baseline.|24 Months|Per protocol||participants|||Number
754699|NCT00578812|Secondary|Mean Neck Disability Index (NDI)|Mean NDI at 24 months on a 0-100 scale (lower value is better).|24 Months|Per protocol||units on a scale||Standard Deviation|Mean
754700|NCT00578812|Secondary|Clinically Significant Improvement on Neck Disability Index (NDI)|Improvement in NDI of ≥15-points at 24 months compared to baseline.|24 Months|Per protocol||participants|||Number
754701|NCT00578812|Secondary|Clinically Significant Improvement on Neck Disability Index (NDI)|Improvement in NDI of ≥20% at 24 months compared to baseline.|24 Months|Per protocol||participants|||Number
754702|NCT00578812|Secondary|Mean Worst Arm Pain Visual Analog Scale|Mean worst arm pain at 24 months on a 0-100mm Visual Analog Scale (lower value is better).|24 Months|Per protocol||mm||Standard Deviation|Mean
754703|NCT00578812|Secondary|Worst Arm Pain Visual Analog Scale|Improvement of ≥20mm in worst arm pain at 24 months compared to baseline.|24 Months|Per protocol||participants|||Number
754704|NCT00578812|Secondary|Mean Neck Pain Visual Analog Scale|Mean neck pain at 24 months on a 0-100 mm Visual Analog Scale (lower value is better).|24 Months|per protocol||mm||Standard Deviation|Mean
754705|NCT00578812|Secondary|Neck Pain Visual Analog Scale|Improvement of ≥20mm in neck pain at 24 months compared to baseline.|24 Months|per protocol||participants|||Number
754706|NCT00578812|Primary|Individual Patient Overall Success|Individual patient overall success defined as ≥20% improvement in Neck Disability Index (NDI) from preoperative score, no device failures requiring revision, reoperation or removal, and the absence of radiographic or major complications during the 24-month follow-up period.|24 Months|Per Protocol||participants|||Number
754720|NCT00585351|Secondary|Prevention of Chemical Pneumonitis|Number of subjects that did not develop aspiration pneumonia in the intervention group (Ranitidine vs. placebo).|Assessed on the day of discharge (average length of stay is approximately 3-7 days)|Intention to treat analysis for secondary outcome (number of participants with aspiration pneumonia).||Participants|||Number
754707|NCT00585169|Primary|Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling (PG-YBOCS)|The PGYBOCS is a reliable & valid, 10-item, clinician administered scale that rates gambling symptoms within the last 7 days. The first 5 questions assess urges and thoughts associated with pathological gambling, and the last 5 questions assess the behavioral component of the disorder. Scores of 0 through 4 are assigned each item according to the severity of the response (0 = least severe response or none, 4 = most severe response or extreme)with a score ranging from 0-40. Each set of questions (1-5 and 6-10) can be totaled separately for the component score (urges/thoughts and behavioral) as well as together for a total score. A score of 0 indicates no problems while increasing scores indicate increasing severity of problems with gambling. PG-YBOCS is used to measure changes across time. A decreasing score indicates a possible positive response to the intervention. Total score at baseline was compared with the study end to determine if the intervention was efficacious.|Baseline to study end point (10 weeks)|All participants who completed at least one study visit were included in the analysis.||units on a scale||Standard Deviation|Mean
754708|NCT00585182|Secondary|Clinically Relevant Bleeding||Through hospitalization|||# events|||Number
754709|NCT00585182|Primary|Peak Low Molecular Weight Heparin Anti-Xa Activity Level.|The Rotachrom® assay using the STA-Compact instrument (Diagnostica Stago, Parsippany, NJ) was used to quantitate anti- Xa (LMWH) activity for enoxaparin. The sensitivity of this assay is 0.2 U/mL and within run imprecision is 5.5 (% CV) at 1 U/mL. The assay is linear between 0.2-2.0 U/mL|Day 2|||IU/mL||Standard Deviation|Mean
754710|NCT00585221|Primary|Time to Progression (TTP).||two years||||||
754711|NCT00585221|Primary|Decrease in Tumor Size.|Response rate is measured by PET-CT scan (a decrease in standardized uptake value (SUV) by 25%), Response Evaluation Criteria in Solid Tumors (RECIST), and Choi criteria (10% decrease in tumor size or a 15% decrease in tumor density on contrast-enhanced CT, computed tomography, scan).|18 months||||||
754712|NCT00585286|Secondary|Pain Tolerance|"The average pain score reported over all three treatments was 5.67, corresponding to moderate pain based on a 10-point scale. The pain score is recorded on a 10-point scale, with 0 being no pain and 10 being worst pain imaginable. All subjects reported that any discomfort associated with the procedure was only during active intervention and resolved immediately post-procedure. Increased pain scores correlated with increased density, but not increased energy."|At treatment visit (up to 3 visits)|Out of 15 subjects enrolled at our site, one was lost to follow up before the 3 month follow up for the first treatment. Therefore, data was analyzed for the 14 patients that completed the study.||units on a scale||Standard Deviation|Mean
754713|NCT00585286|Primary|Degree of Atrophy|Subject assessment of the percent improvement in extent of atrophy compared to baseline and based on the quartile scale (0: no improvement; 1: 1–25% improvement; 2: 26–50%; 3: 51–75%; 4: 76–100% improvement).|Baseline, 1 month and 3 months post-treatment|Out of 15 subjects enrolled at our site, one was lost to follow up before the 3 month follow up for the first treatment. Therefore, data was analyzed for the 14 patients that completed the study.||units on a scale||Standard Deviation|Median
754714|NCT00585286|Primary|Average Improvement in Surface Texture|Subject assessment of the percent improvement of surface texture compared to baseline and based on the quartile scale (0: no improvement; 1: 1–25% improvement; 2: 26–50%; 3: 51–75%; 4: 76–100% improvement).|Baseline, 1 month and 3 months post-treatment|Out of 15 subjects enrolled at our site, one was lost to follow up before the 3 month follow up for the first treatment. Therefore, data was analyzed for the 14 patients that completed the study.||units on a scale||Standard Deviation|Median
754715|NCT00585286|Primary|Overall Improvement of Acne Scarring|Subject assessment of the percent improvement of acne scarring compared to baseline and based on the quartile scale (0: no improvement; 1: 1–25% improvement; 2: 26–50%; 3: 51–75%; 4: 76–100% improvement).|Baseline, 1 month and 3 months post-treatment|Out of 15 subjects enrolled at our site, one was lost to follow up before the 3 month follow up for the first treatment. Therefore, data was analyzed for the 14 patients that completed the study.||units on a scale||Standard Deviation|Mean
754716|NCT00585312|Secondary|Colorectal Polyp Burden|"The polyp burden was defined as the sum of the largest diameters of all polyps (>2 mm in size) over Years 1 - 5 cumulatively.
Weighted colorectal polyp burden over Years 1 – 5 cumulatively was defined as the polyp burden over Years 1 - 5 divided by the number of colonoscopies that the participant had during the study."|Years 1 - 5|ITT population (N: 106) consisted of all participants who were randomized and assigned to a treatment. Study was early terminated due to low enrollment and lower than expected endpoint rate and no analysis was performed.||mm||Standard Deviation|Mean
754717|NCT00585312|Secondary|Total Number of Colorectal Polyps|"Total number of colorectal polyps >2 mm in size, that were detected over Years 1 - 5 cumulatively.
Weighted total number of colorectal polyps over Years 1 – 5 cumulatively was defined as the total number of colorectal polyps >2 mm in size, that were detected over Years 1 - 5, divided by the number of colonoscopies that the participant had during the study."|Years 1 - 5|ITT population (N: 106) consisted of all participants who were randomized and assigned to a treatment. Study was early terminated due to low enrollment and lower than expected endpoint rate and no analysis was performed.||polyps||Standard Deviation|Mean
754718|NCT00585312|Secondary|Time to Treatment Failure|"Time to treatment failure was defined as time from randomization to the earliest occurrence of one or more of the following:
Appearance of ≥20 polyps (>2 mm in size) at any colonoscopy during the study (Polyps), or
Diagnosis of colorectal malignancy (ColMal), or
Treatment related dropout (DO). The treatment related dropout was defined as insufficient clinical response, progression of disease, death, adverse event, treatment-related laboratory abnormality, subject no longer willing to participate in study, and other reasons that might be related to treatment as determined by treating physicians in a blind fashion before database release."|5 years|ITT population (N: 106) consisted of all participants who were randomized and assigned to treatment. Secondary outcome measure was met by 14 (Polyp:7,ColMal:0,DO:14) participants in the Celecoxib and 14 (13,0,12) in the placebo group. Study was early terminated due to low enrollment and lower than expected endpoint rate. No analysis was performed.||years||Standard Deviation|Mean
754721|NCT00585351|Primary|The Benefit of Advanced Notification in Promoting Informed Consent|Number of subjects that provided informed consent for study (advanced notification vs. no advanced notification).|Assessed at time of enrollment into the study.|Intention to treat analysis for primary outcome (number of patients consented).||Participants|||Number
755323|NCT00593606|Primary|Change in Hematocrit|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||l/l*100||Standard Deviation|Mean
754722|NCT00585377|Secondary|Evaluation of Response Rate|The percentage of patients in which response (CR + PR) was observed: Per Response Evaluation Criteria In Solid Tumors (RECIST v1.0) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions|2 years|||percentage of participants||95% Confidence Interval|Number
754723|NCT00585377|Secondary|Evaluation of Progression-free Survival|The length of time during and after bevacizumab-erlotinib that a patient lives with the disease but does not progress according to RECIST 1.0 Criteria. Per Response Evaluation Criteria In Solid Tumors (RECIST v1.0) for target lesions and assessed by CT: Progressive Disease (PD), >=20% increase in the sum of the longest diameter of target lesions|2 years|||weeks||95% Confidence Interval|Median
754724|NCT00585377|Primary|Evaluation of Overall Survival|The length of time from the start of treatment for a disease that patients are still alive.|2 years|All patients were included in response assessment based on intention to treat including those who received less than 6 weeks of therapy||weeks||95% Confidence Interval|Median
754725|NCT00585468|Primary|Area Under the Curve From Time Zero to 12 Hours Post-Dose [AUC (0-12)] of Mycophenolic Acid Glucuronide (MPAG)|AUC (0-12) = Area under the plasma concentration versus time curve from time zero (pre-dose) to 12 hours post-dose, measured in microgram-hours per milliliter (mcg*h/mL)|0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose|||mcg*h/mL||Standard Deviation|Mean
754726|NCT00585468|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Mycophenolic Acid Glucuronide (MPAG)||0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose|||hours||Full Range|Median
754727|NCT00585468|Primary|Minimum Observed Plasma Concentration (Cmin) of Mycophenolic Acid Glucuronide (MPAG)||0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose|||micrograms per milliliter||Standard Deviation|Mean
754728|NCT00585468|Primary|Maximum Observed Plasma Concentration (Cmax) of Mycophenolic Acid Glucuronide (MPAG)||0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose|||micrograms per milliliter||Standard Deviation|Mean
754729|NCT00585468|Primary|Area Under the Curve (AUC) From Time Zero to 12 Hours Post-Dose [AUC (0-12)] of Mycophenolic Acid (MPA)|AUC (0-12) = Area under the plasma concentration versus time curve from time zero (pre-dose) to 12 hours post-dose, measured in microgram-hours per milliliter (mcg*h/mL)|0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose|||mcg*h/mL||Standard Deviation|Mean
754730|NCT00585468|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Mycophenolic Acid (MPA)||0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose|||hours||Full Range|Median
754731|NCT00585468|Primary|Minimum Observed Plasma Concentration (Cmin) of Mycophenolic Acid (MPA)||0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose|||micrograms per milliliter||Standard Deviation|Mean
754732|NCT00585468|Primary|Maximum Observed Plasma Concentration (Cmax) of Mycophenolic Acid (MPA)||0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose|||micrograms per milliliter||Standard Deviation|Mean
754733|NCT00585910|Secondary|Clinical Global Impressions - Level of Severity (CGIs) for ADHD and Other Psychiatric Disorders|Secondary analyses allowed us to evaluate the effects of treatment on additional measures of functioning (CGIs for ADHD and other psychiatric disorders). The CGI-Severity scale is as follows: 0 = Not assessed, 1 = normal, not at all ill, 2 = Borderline mentally ill, 3 = Mildly ill, 4 = Moderately Ill, 5 = Markedly Ill, 6 = Severely Ill, 7 = Among the most extremely ill patients.|7 weeks|||Units on a Scale||Full Range|Mean
754734|NCT00585910|Primary|Attention Deficit Hyperactivity Disorder Rating Scale (ADHD RS)|The primary outcome was the ADHD rating scale. Change scores for the ADHD Rating Scale (RS), from baseline to endpoint (week 7 or last observation carried forward), were analyzed with paired t-tests and nonparametric Wilcoxon sign-rank tests. The best score is a score of 0 (no ADHD symptoms) and the worst score is the highest score possible (54).|7 weeks|All analyses were intent to treat, with last observation carried forward.||Units on a Scale||Standard Deviation|Mean
754735|NCT00585923|Secondary|Level of Function (Neck Disability Index)|Number of patients who have an improved, maintained or decreased level of function based on the results of their NDI (Neck Disabillity Index) from surgery to last follow-up visit. The NDI scale ranges from 0-100. If a subject has a score of 0, it means that they have no limitations and no pain. This is calculated by subtracting the NDI at the last follow-up from the NDI at the baseline visit.|Baseline and Last follow-up visit (Last follow-up ranged from no visit after surgery to 24 months of follow-up)|||Participants|||Number
754736|NCT00585923|Secondary|Neurological Status Change in Neurological Status Since Surgery.|Patients were categorized as maintained, improved or decreased Neurological Status. This was assessed pre-operatively and at each follow-up visit but reported on last follow-up. Motor Function was measured at each cervical level Reflex Function (0: Not elicitable; 1: Elicited with reinforcement; 2: Normal; 3:Brisk; 4:Clonus, unsustained; 5: Clonus, sustained) was measured for Bicep, Brachioradialis, and Triceps Sensory Function (0: Sensation is absent; 1: Sensating is diminished; 2: Sensation is normal; 3: Sensation is present, but pathological, was measured at each cervical dermatome|Baseline and Last follow-up visit (Last follow-up ranged from no visit after surgery to 24 months of follow-up)|||Participants|||Number
754737|NCT00585923|Secondary|Pain With Activity|"Pain is calculated by patient making an X on a visual analog scale (VAS) line at each visit. Mark on x is measured via a mm ruler. Number of Participants with the Level of Pain with Activity Improved, Maintained or Worsened from Baseline to last follow-up visit. This is calculated by subtracting the pain at the last follow-up from the pain at the baseline visit. Scores range from 0 to 100 with 0 being the best score."|Baseline and Last follow-up visit (Last follow-up ranged from no visit after surgery to 24 months of follow-up)|||Participants|||Number
754738|NCT00585923|Secondary|Pain at Rest|"Pain is calculated by patient making an X on a visual analog scale (VAS) line at each visit. Mark on x is measured via a mm ruler. Number of Participants with the Level of Pain at Rest Improved, Maintained or Worsened from Baseline to last follow-up visit. This is calculated by subtracting the pain at the last follow-up from the pain at the baseline visit. Best Case is 0 and worst case is 100."|Baseline and Last Follow-Up visit (Last follow-up ranged from no visit after surgery to 24 months of follow-up)|||Participants|||Number
754750|NCT00586105|Secondary|Overall Survival (OS)|Overall survival (OS) was measured from the date of first dose of study drug until the date of death due to any cause. Survival time for subjects still alive at the time of analysis was censored at the date of last contact.|Time from start of therapy to death up to 17.25 months|All subjects who received at least 1 dose of drug (the intent to treat [ITT] population) were included in the analysis. Thirty-nine patients received at least 1 dose of drug.||months||Full Range|Median
754739|NCT00585923|Primary|Fusion Success|"The fusion criteria will include radiographic evidence of no motion at the affected levels on flexion/extension and evidence of bony bridging and no lucent lines on AP/lateral views.
Fusion Grading
fused”
probably fused”
pseudarthrosis”
This determination was made by Dr. Nunley and there was never any more specific details given on how the determination was made between fused and probably fused."|Last Follow-Up (Last follow-up ranged from no visit after surgery to 24 months of follow-up)|Fusion Status is shown for the last office visit which the patient attended before the doctor withdrew from the study||participants|||Number
754740|NCT00585975|Secondary|Number of Participants That Are Pain Free|Participant description of being pain free taken from patient questionnaire with multiple possible responses|Day 1|||Participant|||Number
754741|NCT00585975|Primary|Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero|Participants with SOIS of 1. Scale: 0=0 cells (complete absence); 0.5=1-5 cells (trace); 1=6-15 cells (very slight); 2=16-25 cells (moderate); 3=26-50 cells (marked); 4=>50 cells (intense)|Day 15|||Participant|||Number
754742|NCT00586066|Secondary|Rapid Visual Information Processing Task (RVP)|"RVP is a sensitive measure of sustained attention. In this test, a white box appears in the center of the screen with digits from 2–9 in a pseudorandom order at a rate of 100 digits per minute. Participants are asked to identify target sequences of three digits and to register responses using the press pad.
RVPA is a measure of target sensitivity (i.e., the ability to discriminate between target and distractors). The outcome is defined as a z-score (statistical deviation from normal). A z-score of 0 is average. Higher z-scores represent better than average performance and negative z-scores represent worse than average performance.
RVPB is an index of response bias (i.e., the tendency to respond or not respond in general). The outcome is defined as a z-score (statistical deviation from normal). A z-score of 0 is average. Higher z-scores represent a stronger tendency to respond and negative z-scores represent a less than average tendency to respond."|Weeks 6 and 12|All randomized participants with data available at the given time-point.||z-score||Standard Deviation|Mean
754743|NCT00586066|Primary|California Verbal Learning Test (CVLT) at Week 6|The CVLT is used to measure verbal learning and episodic long-term memory. It assesses learning, short- and long-delayed recall and recognition for a list of 16 shopping items. Subjects are expected to remember a list of words. They are asked to repeat the words remembered 5 times (5 trials). Each of the words correctly remembered, in each trial, is marked as 1 point. The reported data represent the number of correct items for the Trial 1, Trial 5, Short Delay Free Recall, and Long Delay Free Recall. The long-delayed recall is assessed at 20 minutes. The CVLT enables a comprehensive characterization of a participant's memory profile.|Week 6|All Randomized participants with data available at Week 6.||correct items||Standard Deviation|Mean
754744|NCT00586066|Primary|California Verbal Learning Test (CVLT) at Week 12|The CVLT is used to measure verbal learning and episodic long-term memory. It assesses learning, short- and long-delayed recall and recognition for a list of 16 shopping items. Subjects are expected to remember a list of words. They are asked to repeat the words remembered 5 times (5 trials). Each of the words correctly remembered, in each trial, is marked as 1 point. The reported data represent the number of correct items for the Trial 1, Trial 5, Short Delay Free Recall, and Long Delay Free Recall. The long-delayed recall is assessed at 20 minutes. The CVLT enables a comprehensive characterization of a participant's memory profile.|Week 12|All Randomized participants with data available at Week 12.||correct items||Standard Deviation|Mean
754745|NCT00586105|Secondary|Time to Objective Response|Time to objective response was defined as the time from the date of receipt of first dose of study drug to first assessment showing a confirmed PR or CR.|Time from start of study medication to first documented PR or CR up to 17.25 months|All subjects who received at least 1 dose of drug (the intent to treat [ITT] population) were included in the analysis. Thirty-nine patients received at least 1 dose of drug. Time to objective response was determined on the 5 subjects who had a PR.||months||Full Range|Median
754746|NCT00586105|Secondary|Overall Response Duration|Overall response duration was to be calculated for subjects who had a confirmed PR or CR, defined as the time from first assessment showing a PR or CR to progression or death.|From PR or CR to progression or death up to 17.25 months|All subjects who received at least 1 dose of drug (the intent to treat [ITT] population) were included in the analysis. Thirty-nine patients received at least 1 dose of drug. The overall response duration was determined on the 5 subjects who had a PR.||months||Full Range|Median
754747|NCT00586105|Secondary|Overall Best Response|The best overall response was defined as the number of subjects with a confirmed CR, PR, SD, or PD. Tumor response was evaluated using RECIST. PD: at least a 20% increase in the sum of LD of measured lesions taking as ref. the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Appearance of new lesions will also constitute PD. In exceptional circumstances, unequivocal progression of a non-measured lesion may be accepted as evidence of disease progression.|Best response observed from start to end of study medication up to 17.25 months|All subjects who received at least 1 dose of drug (the intent to treat [ITT] population) were included in the analysis. Thirty-nine patients received at least 1 dose of drug.||participants|||Number
754748|NCT00586105|Secondary|Disease Control (DC)|The DC was defined as subjects who had a best response rating of complete response (CR), partial response (PR), or stable disease (SD) according to Response Evaluation Criteria in Solid Tumors (RECIST) that was maintained for at least 28 days from the first demonstration of that rating. CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target). PR: at least a 30% decrease in the sum of longest diameters (LD) of target lesions taking as reference the baseline sum LD. SD: steady state of disease; do not qualify for PR or progressive disease (PD).|From start to end of study medication up to 17.25 months|All subjects who received at least 1 dose of drug (the intent to treat [ITT] population) were included in the analysis. Thirty-nine patients received at least 1 dose of drug.||participants|||Number
754749|NCT00586105|Secondary|Time to Progression (TTP)|Time to progression (TTP) was defined as the time from date of receipt of first dose of study drug to disease progression, radiological or clinical. Subjects without tumor progression at the time of analysis were censored at their last date of tumor evaluation.|Time from start of study medication to clinical or radiological disease progression which ever occurs first up to 17.25 months|All subjects who received at least 1 dose of drug (the intent to treat [ITT] population) were included in the analysis. Thirty-nine patients received at least 1 dose of drug.||months||95% Confidence Interval|Median
782717|NCT00807560|Secondary|BMI|Body Mass Index: this variable informs the calculation of the outcome variable of BMI z-score.|baseline|||kg/m^2||Standard Deviation|Mean
754751|NCT00586105|Secondary|Progression Free Survival (PFS)|Progression-free survival (PFS) was defined as the time from the date of receipt of first dose of study drug to disease progression, radiological or clinical, or death, whichever was earlier. Subjects still alive without tumor progression at the time of analysis were censored at their date of last tumor evaluation.|Number of days from date of first dose of study drug to date first observed disease progression or death (whichever was earlier) was documented up to 17.25 months|All subjects who received at least 1 dose of drug (the intent to treat [ITT] population) were included in the analysis. Thirty-nine patients received at least 1 dose of drug.||months||95% Confidence Interval|Median
754752|NCT00586105|Primary|Pharmacokinetics Measured as Concentration (Cmax Normalized at Tmax and Cmin Normalized at Tmin)|Cmax (maximum concentration) was measured at the time point at which the maximum concentration (Tmax) was observed. Cmin (minimum concentration) was measured at the time point at which the minimum concentration (Tmin) was observed. The normalized variables (Cmax norm and Cmin norm) are the variables (Cmax and Cmin, see Primary Outcome Measure 2) divided by [dose (mg)/weight (kg)].|12 hours after at least 21 days of uninterrupted dosing|A full PK profile was obtained in 32 of the 39 patients after at least 21 days of uninterrupted BID dosing.||Kg/L||Standard Deviation|Mean
754753|NCT00586105|Primary|Pharmacokinetics Measured as Concentration (Cmax at Tmax and Cmin at Tmin)|Cmax (maximum concentration) was measured at the time point at which the maximum concentration (Tmax) was observed. Cmin (minimum concentration) was measured at the time point at which the minimum concentration (Tmin) was observed.|12 hours after at least 21 days of uninterrupted dosing|A full PK profile was obtained in 32 of the 39 patients after at least 21 days of uninterrupted BID dosing.||mg/L||Standard Deviation|Mean
754754|NCT00586105|Primary|Pharmacokinetics Measured as Area Under Curve (AUC[0-12h])|The AUC(0-12h) was the observed AUC, calculated using a combination of linear and log trapezoidal rules, from pre-dose to 12 hours post-dose. The normalized AUC (AUC norm) is AUC (0-12h) divided by (dose [mg]/weight [kg]).|12 hours after at least 21 days of uninterrupted dosing|A full pharmacokinetics (PK) profile was obtained in 32 of the 39 patients after at least 21 days of uninterrupted twice daily (BID) dosing.||mg*hour/Liter||Standard Deviation|Mean
754755|NCT00586157|Primary|Efficacy Defined as Change From Baseline on the Investigator Rated DSM-IV Based ADHD Rating Scale, During the AM.|Units on a scale range from 0-3 on a scale of severity, with 0 being the least severe item score and 3 being the most severe. The possible range of scores for the scale is 0 (least severe) to 54 (most severe).|Baseline and 4 weeks|||Units on a scale||Standard Deviation|Mean
754756|NCT00586157|Secondary|Efficacy Defined as Change From Baseline on Investigator and Parental/Self-report Based Rating Scales and Questionnaires|"The questionnaire includes two a sections, a clinician rated 20-item scale and a 14-item self-report section completed collaboratively by child and parent/guardian.
Units on the clinician rated scale range from 0-3 on a scale of severity, with 0 being the least severe item score and 3 being the most severe. Units on the self-report section ranged from 0-2 on a scale of severity, with 0 being the least severe item score and 2 being the most severe. The possible range of scores for the questionnaire is 88"|Baseline and 4 weeks|||Units on a scale||Standard Deviation|Mean
754757|NCT00586157|Primary|Efficacy Defined as Change From Baseline on the Investigator Rated DSM-IV Based ADHD Rating Scale, Over the Course of the Day.|Units on a scale range from 0-3 on a scale of severity, with 0 being the least severe item score and 3 being the most severe. The possible range of scores for the scale is 0 (least severe) to 54 (most severe).|Baseline and 4 weeks|||Units on a scale||Standard Deviation|Mean
754758|NCT00586170|Secondary|Mean AOFAS Score (% Change From Baseline), Foot Function Index (% Change From Baseline), SF-36 Health Survey (Change From Baseline)||24 Weeks|No AOFAS, Foot Function Index, or SF-36 Health Survey data was collected or analyzed.|||||
754759|NCT00586170|Primary|Percentage of Successful 5th Metatarsal Unions Achieved.|Each patient was assessed radiographically at 2, 4, 6, 8, 12, 16, 20, and 24 weeks or until radiographic signs of healing were evident. The radiographs were evaluated and graded by the number of cortices (medial and lateral on anteroposterior views as well as dorsal and plantar on lateral views) of healing at each time point. Bridging callus across 4 cortices on postoperative radiographs was used to determine healing.|24 Weeks|Each patient had 1 fracture. The number of fractures treated equals the number of patients treated in both treatment groups.||percentage of fractures healed|Fractures||Number
754760|NCT00586196|Secondary|Change From Baseline and MDAS Scores Over Time|Measures severity of 10 delirium symptoms items (0 not present, 1 mild, 2 moderate, 3 severe) yielding a total score of 0 to 30, with 30 most severe.|Baseline, hospital discharge, weeks 2, 4 and 6|Based on ability to recruit||units on a scale||Standard Deviation|Mean
754761|NCT00586196|Primary|Percentage of Participants With Delirium Using the CAM Over Time|Confusion Assessment Method (CAM)—Measure of the presence or absence of delirium. Requires 1) acute change with fluctuating course, 2) inattention, and either 3) disorganized thinking or 4) altered level of consciousness.|Baseline, hospital interviews, weeks 2, 4 and 6|||percentage of participants|||Number
754762|NCT00586261|Primary|Change in Brachial Arterial Reactivity|Brachial arterial reactivity was measured by ultrasound. A blood pressure cuff was placed around the right forearm. Using the ultrasound probe of the ultrasound, 2-dimensional images clearly defining the anterior and posterior intimal wall of the brachial artery were collected. Flow velocities were then measured using pulsed wave Doppler. The blood pressure cuff previously placed around the patient’s right forearm was inflated to 200 mmHg. The cuff remained inflated for 5 minutes as the patient remained motionless and quiet. Prior to deflation, the patient was asked to remain still as flow velocities and 2-dimensional images were obtained immediately following cuff deflation. Then a 0.4 mg sublingual nitroglycerin tablet was given to all patients without a contraindication and all measurements were repeated.|After 6 months of treatment|The study was stopped early due to low recruitment and no evidence of an effect in this analysis.||mm||Standard Error|Mean
754763|NCT00586313|Secondary|The Number of Procedural Complications|Major procedural complications could include: hospitalization, surgery or a radiologic procedure to correct an adverse event; bleeding, infection. Minor procedural complications could be increase in abdominal pain, self-limited hypoxia, bradycardia, tachycardia, hypo or hyper-tension, change in vital signs.|24 months|||complications|||Number
754764|NCT00586313|Primary|Median Total Specimen Length|Median Total Specimen Length grouped for indication for liver biopsy: Suspected NAFLD, Intrahepatic Cholestasis, Exclusion of Cirrhosis, Increased Liver Function Tests (LFTs) of Uncertain Cause and the Total.|24 months|||mm||Full Range|Median
754769|NCT00586326|Primary|Local Control Rate for Follow-up Period of 5 Years.|Failure of local control was defined as a histologically confirmed recurrence (invasive or non-invasive) within the prescription isodose volume. All recurrences were to have histological evaluation per the protocol; however, the case report forms did not provide space for this data to be captured. Ipsilateral axillary, infraclavicular, internal mammary, or supraclavicular recurrence or distant metastases were not considered treatment failures unless accompanied by ipsilateral breast failure.|Data collected at the time of implant, radiation therapy, and at the patient's 3 month, 6 month, 1 year, 2 year, 3 year, 4 year and 5 year follow-up visits.|||percentage of subjects|||Number
754803|NCT00586469|Secondary|The Fold Increase in Anti-HI GMTs for Influenza Antigens H3 and B|"The fold increase in anti-HI GMTs for influenza antigen H1 is presented in the previous table.
The fold increase corresponds to the Unit of Measure Factor."|At Day 21 compared to Day 0|Analysis was performed on the According-To-Protocol cohort for immunogenicity, including subjects for whom results were available for that particular timepoint and who were not eliminated due to exclusion criteria.||Factor|||Number
782718|NCT00807560|Secondary|Weight|This variable informs the calculation of the outcome variable of BMI z score.|up to 44 weeks|||pounds||Standard Deviation|Mean
782719|NCT00807560|Secondary|Weight|This variable informs the calculation for the outcome variable of BMI Z score.|baseline|||pounds||Standard Deviation|Mean
754799|NCT00586469|Secondary|Number of Participants Reporting Serious Adverse Events (SAE)|An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|Within 21 days after vaccination|||participants|||Number
754800|NCT00586469|Secondary|Number of Participants Reporting Unsolicited Adverse Events (AE).|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|During the 21-day period following each vaccination.|The analysis was performed on the Total Vaccinated Cohort.||participants|||Number
754801|NCT00586469|Secondary|Number of Participants Reporting Solicited General Symptoms|Solicited general symptoms assessed include bronchospasm, chills, cough, fatigue, fever, headache, joint pain at other location, muscle aches, red eyes, sore throat, and swelling of the face|During the 4-day period following each vaccination.|Analysis was performed on the Total Vaccinated cohort.||participants|||Number
754804|NCT00586469|Secondary|Seroconversion Factors Defined as the Fold Increase in Serum HI GMTs Post-vaccination for Influenza Antigen H1N1|Seroconversion factors are defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0, at Day 21. This table presents the SCF for the H1 strain. The SCF for the other strains are addressed in the next table.|At Day 21 compared to Day 0|Analysis was performed on the According-To-Protocol cohort for immunogenicity, including subjects for whom results were available for that particular timepoint and who were not eliminated due to exclusion criteria.||Factor|||Number
754805|NCT00586469|Secondary|Number of Seroprotected Participants.|The table presents the number of participants with a serum haemagglutination inhibition (HI) titer >= 1:40 that usually is accepted as indicating protection.|At Days 0 and 21|Analysis was performed on the According-To-Protocol cohort for immunogenicity, including subjects for whom results were available for that particular timepoint and who were not eliminated due to exclusion criteria.||participants|||Number
754806|NCT00586469|Secondary|Number of Participants Who Seroconverted.|The table shows the number of participants who have either a pre-vaccination titer < 1:10 and a post-vaccination titer >= 1:40 or a prevaccination titer >= 1:10 and at least a 4-fold increase in post-vaccination titer, at Day 21.|At Day 21.|Analysis was performed on the According-To-Protocol cohort for immunogenicity, including subjects for whom results were available for that particular timepoint and who were not eliminated due to exclusion criteria.||participants|||Number
754807|NCT00586469|Secondary|Geometric Mean Titers (GMTs) of the H1 Strain and the GMT of the H3 and B Strains|The table contains GMTs of the H1 strains at Day 0 & 21 and of the H3 and B strains at Day 0 (values at Day 21 for H3 and B strains were primary outcome measures)|At Days 0 and 21|Analysis was performed on the According-To-Protocol cohort for immunogenicity, including subjects for whom results were available for that particular timepoint and who were not eliminated due to exclusion criteria.||Titer||95% Confidence Interval|Geometric Mean
754808|NCT00586469|Primary|Geometric Mean Titers (GMTs) of Anti-H3 and B Strains|GMTs for H1 strain is addressed as a secondary endpoint|At Day 21|Analysis was performed on the According-To-Protocol cohort for immunogenicity, including subjects for whom results were available for that particular timepoint and who were not eliminated due to exclusion criteria.||Titer||95% Confidence Interval|Geometric Mean
754809|NCT00586482|Other Pre-specified|Self-reported Abstinence From Smoking||Post-operative day 8|||participants|||Number
754810|NCT00586482|Other Pre-specified|Minnesota Nicotine Withdrawal Score|This item was measured using the Minnesota Nicotine Withdrawal Questionnaire, self-reported for the prior 24 hour period. This questionnaire consists of 15 items, each rated from 0 to 4, with a possible score of 0 to 60. A lower score indicates lesser withdrawal symptoms, and a higher score indicates greater withdrawal symptoms.|Morning of surgery, pre-operatively|||units on a scale||Standard Deviation|Mean
754811|NCT00586482|Other Pre-specified|Self-reported Time to Last Cigarette||Morning of surgery, pre-operatively|||Hours||Standard Deviation|Mean
754812|NCT00586482|Secondary|Self-reported Abstinence|Mean number who reported abstinence from smoking from the the time of baseline assessment until the morning of surgery.|Morning of surgery, pre-operatively|||participants|||Number
754813|NCT00586482|Primary|Exhaled Carbon Monoxide Concentration||Morning of surgery, pre-operatively|||Parts per million||Standard Deviation|Mean
754814|NCT00586495|Post-Hoc|Number of Participants Who Died|Number of subjects who died due to any cause.|From start of treatment of the first subject until 45 months later, assessed every 3 months|"Overall Survival is shown in Secondary Outcome Measure: Overall Survival."||participants|||Number
754815|NCT00586495|Secondary|Overall Disease Control|Subjects who have a best response rating of CR, PR or Stable Disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started) per RECIST that is maintained for at least 28 days from the first demonstration of that rating.|From start of treatment of the first subject until 45 months later, assessed every 8 weeks|ITT population.||participants|||Number
754816|NCT00586495|Secondary|Time to Objective Response|Time from initiation of treatment to the date when an objective response (CR or PR, whichever is first recorded) is first documented according to RECIST.|From start of treatment of the first subject until 45 months later, assessed every 8 weeks|ITT population.||days||Full Range|Median
754817|NCT00586495|Secondary|Overall Response Duration|Time from the date of first objective response (CR or PR, whichever is first recorded) to the date when progressive disease (PD, at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions) is first documented according to RECIST.|From start of treatment of the first subject until 45 months later, assessed every 8 weeks|ITT population.||days||95% Confidence Interval|Median
754818|NCT00586495|Secondary|Overall Survival (OS)|Time from initiation of treatment to death due to any cause.|From start of treatment of the first subject until 45 months later, assessed every 3 months|"ITT population. The median overall survival (OS) and the lower limit of 95% Confidence interval were not estimable because more than half (n=51) of the study population were censored. The number of participant who died is shown in Post-Hoc Outcome Measure: Number of Participants who Died."|||||
754819|NCT00586495|Secondary|Best Tumor Response|Best tumor response, including Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter) according to the Response Evaluation Criteria in Solid Tumors (RECIST)|From start of treatment of the first subject until 45 months later, assessed every 8 weeks|ITT population||participants|||Number
754820|NCT00586495|Primary|Progression Free Survival (PFS)|Time from initiation of treatment to disease progression (radiological or clinical, whichever earlier) or death (if death occurs before progression).|From start of treatment of the first subject until 45 months later, assessed every 8 weeks|Intention to treat (ITT) population.||days||95% Confidence Interval|Median
754821|NCT00586521|Secondary|Quality of Life Compared to On-demand Treatment as Measured by the Haemo-QoL A Questionnaire|Total transformed score with a range of 0-100, higher values indicate better outcome. 41 items in 6 domains: physical functioning; role functioning; worry; consequences; positive affect; treatment concern.|Month 13 (end of prophylactic treatment) and Month 6 (end of on-demand treatment)|intent-to-treat-population||Transformed score||Standard Deviation|Mean
782720|NCT00807560|Secondary|Height|This variable informs the calculation of the outcome variable of BMI Z score.|up to 44 weeks|||inches||Standard Deviation|Mean
754825|NCT00586573|Primary|DSM-IV ADHD Rating Scale (AISRS) Score Change|"AISRS used to assess 18 individual criteria symptoms of ADHD in DSM-IV on a severity grid (0=not present, 3=severe; minimum score=0, maximum score=54). This is a composite score assessing both inattention and hyperactivity, which are not assessed individually in this scale.
Score change from baseline."|Endpoint, following 12 weeks Memantine Monotherapy|||Units on a scale||95% Confidence Interval|Mean
754826|NCT00586612|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|"SAEs assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Period 1 is defined as 31 days after last primary vaccination until administration of booster dose (Month 14).
Period 2 is defined as the administration of the booster dose until the end of the study (Month 15)."|31 days after last primary vaccination until administration of booster dose (Month 14) and from the administration of the booster dose until the end of the study (Month 15)|Analysis was performed on the Booster Total Vaccinated cohort which included all vaccinated subjects for whom data for the booster phase were available.||subjects|||Number
754827|NCT00586612|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within 31 days after the booster vaccination (month 15)|Analysis was performed on the Booster Total Vaccinated cohort which included all vaccinated subjects for whom data for the booster phase were available.||subjects|||Number
754828|NCT00586612|Secondary|Number of Subjects Reporting Solicited Symptoms (Local and General)|Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include drowsiness, fever, irritability/fussiness and loss of appetite.|During the 4-day follow-up period following booster vaccination|Analysis was performed on the Booster Total Vaccinated cohort which included all vaccinated subjects for whom data for the booster phase were available.||subjects|||Number
754829|NCT00586612|Secondary|Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer|rSBA-MenC titers are given as geometric mean titers (GMTs).|Prior to (Month 14) and one month after the booster vaccination (Month 15)|Analysis was performed on the Booster ATP cohort for immunogenicity, which included subjects having received 3 vaccine doses during the primary vaccination course and the booster vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component after booster dose administration.||titer||95% Confidence Interval|Geometric Mean
754830|NCT00586612|Secondary|Anti-hepatitis B Surface Antigen (Anti-HBs) Concentration|"Anti-HBs concentrations are given as geometric mean concentrations (GMCs) in milli-international units per milliliter (mIU/mL).
Note: Planned analysis in the protocol of HBs after the booster dose was not performed as booster vaccines did not contain HBs component."|Prior to (Month 14) the booster vaccination|Analysis was performed on the Booster ATP cohort for immunogenicity, which included subjects having received 3 vaccine doses during the primary vaccination course and the booster vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component after booster dose administration.||mIU/mL||95% Confidence Interval|Geometric Mean
754831|NCT00586612|Secondary|Anti-polyribosylribitol Phosphate (Anti-PRP) and Anti-polysaccharide C (Anti-PSC) Concentration|Anti-PRP and anti-PSC concentrations are given as geometric mean concentrations (GMCs) in micrograms per milliliter (µg/mL).|Prior to (Month 14) and one month after the booster vaccination (Month 15)|Analysis was performed on the Booster ATP cohort for immunogenicity, which included subjects having received 3 vaccine doses during the primary vaccination course and the booster vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component after booster dose administration.||micrograms per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
754832|NCT00586612|Secondary|Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration Greater Than or Equal to the Cut-off Values|"Anti-HBs antibody cut-off values assessed include 10 milli-international units per milliliter (mIU/mL) and 100 mIU/mL.
Note: the protocol planned an analysis on HBs after the booster dose, but this analysis was not performed as the vaccines administered as booster doses did not contain HBs component."|Prior to (Month 14) the booster vaccination|Analysis was performed on the Booster ATP cohort for immunogenicity, which included subjects having received 3 vaccine doses during the primary vaccination course and the booster vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component after booster dose administration.||subjects|||Number
754833|NCT00586612|Secondary|Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to the Cut-off Values|Anti-PSC antibody cut-off values assessed include 0.3 micrograms per milliliter (µg/mL) and 2.0 µg/mL.|Prior to (Month 14) and one month after the booster vaccination (Month 15)|Analysis was performed on the Booster ATP cohort for immunogenicity, which included subjects having received 3 vaccine doses during the primary vaccination course and the booster vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component after booster dose administration.||subjects|||Number
754834|NCT00586612|Secondary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to the Cut-off Values|rSBA-MenC titer cut-off values assessed include 1:8, 1:32 and 1:128.|Prior to (Month 14) and one month after the booster vaccination (Month 15)|Analysis was performed on the Booster ATP cohort for immunogenicity, which included subjects having received 3 vaccine doses during the primary vaccination course and the booster vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component after booster dose administration.||subjects|||Number
754835|NCT00586612|Secondary|Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 1.0 Migrogram Per Milliliter (µg/mL)|Anti-PRP antibody cut-off value assessed was 1.0 migrogram per milliliter (µg/mL).|Prior to (Month 14) and one month after the booster vaccination (Month 15)|Analysis was performed on the Booster ATP cohort for immunogenicity, which included subjects having received 3 vaccine doses during the primary vaccination course and the booster vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component after booster dose administration.||subjects|||Number
782878|NCT00814983|Primary|The Incidence of Grade II-IV Acute Graft Versus Host Disease||One year from date of transplant|No analysis was performed since the experimental arm was not opened|||||
754836|NCT00586612|Secondary|Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 0.15 Migrogram Per Milliliter (µg/mL)|Anti-PRP antibody cut-off value assessed was 0.15 migrogram per milliliter (µg/mL).|Prior to (Month 14) and one month after the booster vaccination (Month 15)|Analysis was performed on the Booster ATP cohort for immunogenicity, which included subjects having received 3 vaccine doses during the primary vaccination course and the booster vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component after booster dose administration.||subjects|||Number
754837|NCT00586612|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Throughout the entire primary vaccination phase|Analysis was performed on the Primary Total Vaccinated Cohort.||subjects|||Number
754838|NCT00586612|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within 31 days after each primary vaccination|Analysis was performed on the Primary Total Vaccinated Cohort.||subjects|||Number
754839|NCT00586612|Secondary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed include drowsiness, fever, irritability/fussiness and loss of appetite and are presented across doses.|During the 4-day follow-up period after any primary vaccination dose|Analysis was performed on the Primary Total Vaccinated Cohort.||subjects|||Number
754840|NCT00586612|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling and are presented across doses.|During the 4-day follow-up period after any primary vaccination dose|Analysis was performed on the Primary Total Vaccinated Cohort.||subjects|||Number
754841|NCT00586612|Secondary|Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer|rSBA-MenC titers are given as geometric mean titers (GMTs).|One month after the third dose|Analysis was performed on the Primary According-To-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.||Titer||95% Confidence Interval|Geometric Mean
754842|NCT00586612|Secondary|Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer|rSBA-MenC titers are given as geometric mean titers (GMTs).|Before vaccination (at Day 0)|Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.||Titer||95% Confidence Interval|Geometric Mean
754843|NCT00586612|Secondary|Anti-hepatitis B Surface Antigen (Anti-HBs) Concentration|Anti-HBs concentrations are given as geometric mean concentrations (GMCs) expressed in milli-international units per milliliter (mIU/mL).|One month after the third dose|Analysis was performed on the Primary According-To-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.||mIU/mL||95% Confidence Interval|Geometric Mean
754844|NCT00586612|Secondary|Anti-hepatitis B Surface Antigen (Anti-HBs) Concentration|Anti-HBs concentrations are given as geometric mean concentrations (GMCs) expressed in milli-international units per milliliter (mIU/mL).|Before vaccination (at Day 0)|Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.||mIU/mL||95% Confidence Interval|Geometric Mean
754845|NCT00586612|Secondary|Anti-polyribosylribitol Phosphate (Anti-PRP) and Anti-polysaccharide C (Anti-PSC) Concentration|Anti-PRP and anti-PSC concentrations are given as geometric mean concentrations (GMCs) expressed micrograms per milliliter (µg/mL).|One month after the third dose|Analysis was performed on the Primary According-To-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.||micrograms per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
754846|NCT00586612|Secondary|Anti-polyribosylribitol Phosphate (Anti-PRP) and Anti-polysaccharide C (Anti-PSC) Concentration|Anti-PRP and anti-PSC concentrations are given as geometric mean concentrations (GMCs) expressed micrograms per milliliter (µg/mL).|Before vaccination (at Day 0)|Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.||micrograms per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
754847|NCT00586612|Secondary|Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration Greater Than or Equal to (≥) the Cut-off Values|Anti-HBs antibody cut-off values assessed include 10 milli-international units per milliliter (mIU/mL) and 100 mIU/mL.|One month after the third dose|Analysis was performed on the Primary According-To-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.||subjects|||Number
754848|NCT00586612|Secondary|Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration Greater Than or Equal to (≥) the Cut-off Values|Anti-HBs antibody cut-off values assessed include 10 milli-international units per milliliter (mIU/mL) and 100 mIU/mL.|Before vaccination (at Day 0)|Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.||subjects|||Number
754849|NCT00586612|Secondary|Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to (≥) the Cut-off Values|Anti-PSC antibody cut-off values assessed include 0.3 micrograms per milliliter (µg/mL) and 2 µg/mL.|One month after the third dose|Analysis was performed on the Primary According-To-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.||subjects|||Number
754850|NCT00586612|Secondary|Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to (≥) the Cut-off Values|Anti-PSC antibody cut-off values assessed include 0.3 micrograms per milliliter (µg/mL) and 2 µg/mL.|Before vaccination (at Day 0)|Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.||subjects|||Number
754851|NCT00586612|Secondary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to the Cut-off Values|rSBA-MenC titer cut-off values assessed include 1:32 and 1:128.|One month after the third vaccination|Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.||subjects|||Number
756039|NCT00591344|Secondary|Parkinson ’s Disease Quality of Life|PDQ-39 is a composite measure of quality of life in individuals with Parkinson's Disease.|Obtained during initial evaluation & then every 6 six months to end of 2-yr training period||||||
754852|NCT00586612|Secondary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to the Cut-off Values|rSBA-MenC titer cut-off values assessed include 1:8, 1:32 and 1:128.|Before vaccination (at Day 0)|Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.||subjects|||Number
754853|NCT00586612|Secondary|Number of Subject With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 1 Microgram Per Milliliter|Anti-PRP antibody cut-off value assessed include 1 microgram per milliliter (µg/mL).|One month after the third vaccination|Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.||subjects|||Number
754854|NCT00586612|Secondary|Number of Subjects With Anti-Polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to the Cut-off Values|Anti-PRP antibody cut-off values assessed include 0.15 micrograms per milliliter (µg/mL) and 1 µg/mL.|Before vaccination (at Day 0)|Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.||subjects|||Number
754855|NCT00586612|Primary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to 1:8|rSBA-MenC titer greater than or equal to 1:8 is indicative of protection.|One month after the third vaccination|Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.||subjects|||Number
754856|NCT00586612|Primary|Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 0.15 Micrograms Per Milliliter (µg/mL)|Anti-PRP antibody concentration greater than or equal to 0.15 µg/mL is indicative of protection.|One month after the third vaccination|Analysis was performed on the Primary According-to-Protocol (ATP) cohort for immunogenicity, on subjects with available data.||subjects|||Number
754857|NCT00586625|Primary|Ocular Comfort|"A 4-step grading scale with half unit (1-step) increments allowed:
0=Comfortable;discomfort absent; 1.0=Generally comfortable; mild discomfort; 2.0=Some discomfort but tolerable; moderate comfort; 3.0=Severely uncomfortable or intolerable"|Day 8 & Day 22|||Scores on a scale||Standard Deviation|Mean
754858|NCT00586664|Secondary|Ocular Mucus Discharge|"Percent of Eyes with Ocular Mucus Discharge as measured 7, 15 & 20 minutes post-CAC.
Scored as absent or present"|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model|||Percent of Eyes with OMD Present|||Number
754859|NCT00586664|Secondary|Tearing|Percent of Eyes with Tearing as measured 7, 15 & 20 minutes post-CAC. Scored as absent or present|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model|||Percent of Eyes with Tearing Present|||Number
754860|NCT00586664|Secondary|Total Non-Ocular Composite Symptom|Total Non-Ocular Composite Symptom score (Composite of Rhinorrhea, Nasal Pruritus, Ear or Palate Pruritus, and Nasal Congestion): 0 = None; 1.0 = Mild; 2.0 = Moderate; 3.0 = Moderate/Severe; 4.0 = Severe|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model|||Units on a scale||Standard Deviation|Mean
754861|NCT00586664|Secondary|Nasal Congestion|Nasal Congestion score: 0 = None-Breathes freely; 1.0 = Mild-Breathes with difficulty; 2.0 = Moderate-One nostril partially blocked; 3.0 = Moderate/Severe-Both nostrils partially blocked or one nostril completely blocked and the other nostril partially blocked; 4.0 = Severe-Both nostrils completely blocked|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model|||Units on a scale||Standard Deviation|Mean
754862|NCT00586664|Secondary|Ear or Palate Pruritus (Itchy Ear or Palate)|Ear or Palate Pruritus score: 0 = None; 1.0 = Mild-An intermittent tickle sensation; 2.0 = Moderate-A mild continuous itch; 3.0 = Moderate/Severe-A severe itch with desire to rub; 4.0 = Severe-Incapacitating itch with an irresistible urge to rub|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model|||Units on a scale||Standard Deviation|Mean
754863|NCT00586664|Secondary|Nasal Pruritus (Itchy Nose)|Nasal Pruritus score: 0 = None; 1.0 = Mild-An intermittent tickle sensation; 2.0 = Moderate-A mild continuous itch; 3.0 = Moderate/Severe-A severe itch with desire to rub; 4.0 = Severe-Incapacitating itch with an irresistible urge to rub|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model|||Units on a scale||Standard Deviation|Mean
754864|NCT00586664|Secondary|Rhinorrhea (Runny Nose)|Rhinorrhea score: 0 = None; 1.0 = Mild-Sensation of nasal mucus flowing down nasal passage; no discharge present; 2.0 = Moderate-May be associated with post-nasal drip; nasal mucus flow more pronounced; will need to blow nose soon; 3.0 = Moderate/Severe-Nasal mucus discharge requiring occasional wiping with Kleenex; 4.0 = Severe-Uncontrolled nasal discharge; requiring frequent wiping and blowing nose|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model|||Units on a scale||Standard Deviation|Mean
754865|NCT00586664|Secondary|Eyelid Swelling|Eyelid Swelling score: 0 = None; 1.0 = Mild-Detectable swelling of lower and/or upper lid; 2.0 = Moderate-Definite swelling of lower and/or upper lid; 3.0 = Severe-Swelling of lower and/or upper lid to the point that there is a decrease in the space between your upper and lower lids|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model|||Units on a scale||Standard Deviation|Mean
754866|NCT00586664|Secondary|Chemosis|Chemosis score: 0 = None; 1.0 = Mild-Detectable only by slit lamp beam; definite separation of conjunctiva from sclera; 2.0 = Moderate-Visible in normal room light; more diffuse edema; 3.0 = Severe-Conjunctival billowing at the limbus; very diffuse and noticeable; 4.0 = Extremely severe-Overall ballooning of conjunctiva|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model|||Units on a scale||Standard Deviation|Mean
754867|NCT00586664|Secondary|Episcleral Redness|Episcleral Redness score: 0=None; 1.0=Mild-Slightly dilated blood vessels; color of vessels typically pink; 2.0=Moderate-More apparent dilation of blood vessels; vessel color more intense (redder); 3.0=Severe-Numerous, obvious dilated blood vessels; absence of chemosis color is deep red, presence of chemosis may be less red or pink; 4.0=Extremely severe-Large, numerous dilated blood vessels characterized by severe deep red color regardless of chemosis grade|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model|||Units on a scale||Standard Deviation|Mean
754914|NCT00587171|Secondary|Distribution of Fellow Eye Visual Acuity at 17 Weeks|Visual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.|17 weeks|||participants|||Number
754868|NCT00586664|Secondary|Ciliary Redness|Ciliary Redness score: 0=None; 1.0=Mild-Slightly dilated blood vessels; color of vessels typically pink; 2.0=Moderate-More apparent dilation of blood vessels; vessel color more intense (redder); 3.0=Severe-Numerous, obvious dilated blood vessels; absence of chemosis color is deep red, presence of chemosis may be less red or pink; 4.0=Extremely severe-Large, numerous dilated blood vessels characterized by severe deep red color regardless of chemosis grade|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model|||Units on a scale||Standard Deviation|Mean
754869|NCT00586664|Primary|Conjunctival Redness|Conjunctival Redness score: 0=None; 1.0=Mild-Slightly dilated blood vessels; color of vessels typically pink; 2.0=Moderate-More apparent dilation of blood vessels; vessel color more intense (redder); 3.0=Severe-Numerous, obvious dilated blood vessels; absence of chemosis color is deep red, presence of chemosis may be less red or pink; 4.0=Extremely severe-Large, numerous dilated blood vessels characterized by severe deep red color regardless of chemosis grade|15 minutes, 8 hours & 16 hours post-dose from Conjunctival Allergen Challenge (CAC) Model|||Units on a scale||Standard Deviation|Mean
754870|NCT00586664|Primary|Ocular Itching|Ocular Itching score: 0=None; 0.5=Intermittent tickle sensation possibly localized in the corner of the eye; 1.0=Intermittent tickle sensation involving more than the corner of the eye; 1.5=Intermittent all-over tickling sensation; 2.0=Mild continuous itch (can be localized) without desire to rub; 2.5=Moderate, diffuse continuous itch with desire to rub; 3.0=Severe itch with desire to rub; 3.5=Severe itch improved with minimal rubbing; 4.0=Incapacitating itch with irresistible urge to rub|15 minutes, 8 hours & 16 hours post-dose from Conjunctival Allergen Challenge (CAC) Model|||Units on a scale||Standard Deviation|Mean
754871|NCT00586690|Secondary|Efficacy - Disease Progression|Evaluate efficacy of natural killer (NK) cell infusions in terms of number of patients with disease progression.|3 years|Participants who completed cell infusion.||participants|||Number
754872|NCT00586690|Secondary|Efficacy - Overall Survival|Evaluate efficacy of natural killer (NK) cell infusions in terms of overall survival (OS).|8 years|Participants who completed infusion. 9 patients were still alive at the time of this analysis.||months alive post-infusion||Full Range|Mean
754873|NCT00586690|Secondary|Efficacy - Progression Free Survival|Evaluate efficacy of natural killer (NK) cell infusions in terms of progression free survival (PFS) in number of months without disease progression.|3 years|Participants who completed cell infusion.||months||Full Range|Mean
754874|NCT00586690|Primary|Toxicity|Evaluate the toxicity post-infusion including mortality, occurrence of acute graft versus host disease (GVHD) and other severe toxicity until a minimum of 8 weeks following the last infusion, then at least monthly for 3 additional months. Unacceptable toxicity was defined as grade ≥ III aGVHD of the gut or liver or Grade 4 aGVHD of the skin lasting > 7 days; other Grade 4 toxicity from the procedure in the major organs that lasted > 5 days; or treatment-related mortality (TRM). Though these infusions are provided early following transplantation and severe toxicity could still have occurred due to the primary transplant procedure, for this study any aGVHD or other toxicities occurring after the first day of infusion of the natural killer (NK) cell enriched Donor Lymphocyte Infusions (DLIs) is considered here as study related.|5 months|Participants who completed cell infusion.||participants|||Number
754875|NCT00586703|Secondary|Efficacy - Overall Survival|Evaluate the efficacy of the regimen in terms of overall survival (OS).|7 years|Participants who completed infusion.||months||Full Range|Mean
754876|NCT00586703|Primary|Toxicity|Evaluate the safety of NK cell infusion using CD56 monoclonal antibody following nonmyeloablative stem cell transplantation from mismatched donors: Toxicity including mortality, occurrence of acute graft versus host disease (aGVHD) and other severe toxicity.|8 weeks|Participants who were able to receive infusion.||participants|||Number
754877|NCT00586716|Secondary|Negative B and T Cell Crossmatch||1year|Study was terminated and no data for the outcome was collected/analyzed because it could not be located.|||||
754878|NCT00586716|Primary|Elimination of Donor Specific Antibodies||1 year|Study was terminated and no data for the outcome was collected/analyzed because it could not be located.|||||
754879|NCT00586729|Primary|Percentage of Grafted Area That is Viable at Day 14|Percentage area of graft viability at 14 days as determined by clinical assessment of revascularization, adherence of the graft to the wound bed and color|14 days|Per protocol||Percentage area||Standard Deviation|Mean
754880|NCT00586729|Secondary|Hospital Cost Per Patient|Average hospital irrigant cost per patient|Volume used from admission to discharge|Per protocol||Dollars||Standard Deviation|Mean
754881|NCT00586729|Secondary|Length of Stay|Average hospital length of stay in days|0 days, 3 days, 5 days and 14 days post-operation|Per protocol||Days||Standard Deviation|Mean
754882|NCT00586820|Secondary|Percent Change in Creatinine Kinase Isoenzyme Muscle/Brain Type (CK-MB) From Immediately Pre-PCI to 8 and 16 Hours Post-PCI|CK-MB is a cardiac marker that can demonstrate the development of heart muscle necrosis resulting from an acute interruption of blood supply to a part of the heart. CK-MB is measured by a blood test.|immediately pre-PCI, 8 hours post-PCI, 16 hours post-PCI|One subject on the BQ-123 arm was excluded from the analysis due to unsuccessful PCI.||percent change||Inter-Quartile Range|Median
754883|NCT00586820|Primary|Average Peak Velocity (APV) Immediately Following Percutaneous Coronary Intervention (PCI)|Coronary microvascular blood flow will be assessed following successful PCI by measuring APV in the culprit vessel using Doppler echocardiography.|immediately following PCI procedure|One subject on the BQ-123 arm was excluded from the analysis due to unsuccessful PCI.||cm/s||Inter-Quartile Range|Median
754884|NCT00586846|Primary|Radiographic Response|to the induction chemotherapy in the primary tumor and in any metastatic lesions using the Response Evaluation Criteria (RECIST).|2 years|||participants|||Number
754885|NCT00586898|Primary|Response|Complete Response: Normalization of the PSA (< or = to 4.0 for patients with castrate metastatic disease, or < 0.5 for patients with a rising PSA) that is maintained on 3 successive evaluations a minimum of 2 weeks apart. Partial Response: Decrease in PSA value by > or = to 50% from baseline value (without normalization) for 3 successive evaluations a minimum of 2 weeks apart. Stabilization: Patients who do not meet the criteria for PR or PROG for at least 90 days will be considered stable.|6 months|||participants|||Number
754886|NCT00587041|Secondary|24 Hour Urine Oxalate Excretion|The amount of oxalate excreted in the urine over a 24 hour period, a risk for calcium oxalate kidney stones|At end of study, approximately 6 weeks|As urine values for the final visit were not available for 5 subjects, they were not included in the analysis.||mmol/L||Standard Deviation|Mean
754887|NCT00587041|Primary|Change in 24-hour Urinary Supersaturation for Calcium Oxalate|Urine is often supersaturated, which favors precipitation of crystalline phases such as calcium oxalate. However, crystals do not always form in supersaturated urine because supersaturation is balanced by crystallization inhibitors that are also present. Supersaturation is calculated by measuring the concentration of all the ions that can interact. Once these concentrations are known, a computer program can calculate the theoretical supersaturation with respect to the important crystalline phases, eg, calcium oxalate. Values for supersaturated ions are expressed in units of Gibbs free energy.|Time zero (on diet but no drug), 6 weeks (on drug and diet)|As urine values for the final visit were not available for 5 subjects, they were not included in the analysis.||KJoules/mol||Standard Deviation|Mean
754888|NCT00587054|Primary|Overall Survival of Transplant Patients|Calculate the median overall survival of transplant patients|up to 6 years|||Days||Full Range|Median
754889|NCT00587067|Other Pre-specified|Molecular Genetic Changes Associated With These Tumors|Use comparative genomic hybridization and cDNA array from tumor and liver biopsy specimens obtained at the time of operation|5 years||06/2020||||
754890|NCT00587067|Secondary|Disease Progression||Up to 5 years|||Participants|||Count of Participants
754891|NCT00587067|Primary|Number of Patients With Treatment Related Toxicity|Toxicity evaluated and graded according to the National Cancer Institute, CTCAE v4.0|Up to 5 years|||participants|||Number
754892|NCT00587067|Primary|Treatment Response|To assess the efficacy of continuous arterial infusion (HAI) of FUDR (Floxuridine) and dexamethasone (DEX) in patients with unresectable hepatocellular carcinoma (HCC) and intrahepatic cholangiocarcinoma (ICC).|Up to 5 years|||Participants|||Count of Participants
754893|NCT00587132|Primary|Number of Subjects With Evidence of Pancreatic Tumor or Any Secondary Findings of Pancreatic Tumor as Shown by CT.|Subjects will receive the secretin test dose just prior to the CT scan. Definitions: Evidence of Pancreatic Tumor (low-attenuation mass), Secondary Findings of Pancreatic Tumor such as dilated pancreatic duct or liver masses suggestive of liver metastases.|Day 1 of study|All subjects had a normal CT scan. The study was terminated early due to lack of funding. No analysis was done due to the low enrollment.||participants|||Number
754894|NCT00587158|Secondary|Degree of Interstitial Fibrosis on Graft Biopsy at One Year|"Interstitial fibrosis refers to degree of scarring or fibrous tissue formed in the kidney. Renal pathologists reviewed biopsies of the subject's kidney grafts for fibrosis, with results expressed using the Banff schema; Quantitative criteria: ci0 = fibrosis observed in up to 5% of cortical area, ci1 = fibrosis in 6%-25% of cortical area (mild) , ci2 = fibrosis in 26%-50% of cortical area (moderate), ci3 = fibrosis in greater than 50% of cortical area (severe). The degree of interstital fibrosis for this study was defined and reported as follows: a Banff ci score of greater than 0 and less than 2 considered mild fibrosis and a ci score greater than or equal to 2 as moderate to severe fibrosis."|1 year post kidney transplant|Per-protocol analysis; graft biopsies were not available for all subjects||Participants|||Number
754895|NCT00587158|Secondary|24-hour Total Protein in the Urine at 1 Year Post Transplant|A urine total protein test is conducted to detect excess protein in the urine. This test helps determine an individual's kidney functioning. Protein is not usually present in urine; therefore, presence of protein in the urine is a sign of abnormality. The quantity of protein in a sample of urine collected over 24-hour was measured and reported in milligrams per day.|1 year post kidney transplant|Per-protocol analysis. The 24-hour urine collection was not completed for all subjects.||mg/day||Standard Deviation|Mean
754896|NCT00587158|Secondary|Mean Change in Estimated Glomerular Filtration Rate (eGFR) Between 3 Weeks and 1 Year Post Transplant||3 weeks, 1 year post kidney transplant|Per-protocol analysis||mL/min/1.73 m^2||Standard Deviation|Mean
754897|NCT00587158|Secondary|Mean Estimated Glomerular Filtration Rate (eGFR) at One Year|Glomerular filtration rate describes the amount that fluid is filtered through the kidney and can be estimated by using serum creatinine. eGFR is reported in milliliters per minute per 1.73 m^2 of body-surface area.|1 year post kidney transplant|Per-protocol analysis||mL/min/1.73m^2||Standard Deviation|Mean
754898|NCT00587158|Secondary|Episodes of Acute Cellular Rejection (ACR) of the Renal Transplant|The number of episodes of ACR, as proven by renal biopsy, were recorded.|Baseline to 1 year post kidney transplant|Per-protocol analysis.||episodes|||Number
754899|NCT00587158|Secondary|Number of Subjects Who Died or Lost Their Renal Graft During First Year|The number of subject who died (or experienced failure of their kidney surgical graft) during the first year following kidney transplant are reported here.|Baseline to 1 year post kidney transplant|Per-protocol analysis.||participants|||Number
754900|NCT00587158|Secondary|Change in Hip Bone Mineral Density (BMD)|BMD was measured using a Dual Energy X-ray Absorptiometry (DEXA) scan and reported by T-scores, measurements made of the hip bones using the scan. The T-score reflects how your bone density measurement compares to normal healthy adults. A normal bone density results in a T-score between +1.0 and -1.0. A T-score of less than or equal to -1.5 was used for this study to define the presence of osteopenia/osteoporosis. Osteopenia is a condition of decreased bone mass or density but not thin enough to be diagnosed as osteoporosis. Osteoporosis is a condition where bone mass/density has diminished to a level causing higher risk of fracture. The average change in T-score from baseline to one year is reported.|Baseline, 1 year post kidney transplant|Per-protocol analysis. Not all subjects were able to undergo the DEXA scan of the hip at baseline and one-year [Control n = 41/Treatment n = 40].||T-score||Standard Deviation|Mean
754901|NCT00587158|Secondary|Change in Lumbar Spine Bone Mineral Density (BMD)|BMD was measured using a Dual Energy X-ray Absorptiometry (DEXA) scan and reported by T-scores, measurements of the lower spine made using the scan. The T-score reflects how your bone density measurement compares to normal healthy adults. A normal bone density results in a T-score between +1.0 and -1.0. A T-score of less than or equal to -1.5 was used for this study to define the presence of osteopenia/osteoporosis. Osteopenia is a condition of decreased bone mass or density but not thin enough to be diagnosed as osteoporosis. Osteoporosis is a condition where bone mass/density has diminished to a level causing higher risk of fracture. The average change in T-score from baseline to one year is reported.|Baseline, 1 year post kidney transplant|Per-protocol analysis; Not all subjects were able to undergo the DEXA scan of the spine at baseline and one-year [Control n = 42/Treatment n = 41].||T-score||Standard Deviation|Mean
755324|NCT00593606|Primary|Change in Percentage of Eosinophilic Granulocytes in White Blood Cell Count|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||Percentage of white blood cell count||Standard Deviation|Mean
754902|NCT00587158|Secondary|Serum Bone Alkaline Phosphatase (BAP) Level Over Time|BAP is a marker of bone turn-over, is measured in the serum and reported in micrograms per liter (mcg/L).|Baseline, 21 days, 90 days and 1 year post kidney transplant|"Per-protocol analysis; the number of samples obtained at each time point varied because not all subjects were able to undergo laboratory testing at the specified study visits. The number of subjects samples per treatment group were as follows [Timepoint: Control(n)/Treatment(n)]:
Baseline: 43/41, Day 21: 34/38, Day 90: 36/36, Day 365: 43/41"||mcg/L||Full Range|Median
754903|NCT00587158|Secondary|Serum Parathyroid Hormone (PTH) Level Over Time|Parathyroid hormone (PTH) is a hormone synthesized in the body's parathyroid glands that controls bone health. PTH controls calcium and phosphorus levels in the body. It is measured in the serum and reported in picograms per milliliter (pg/mL).|Baseline, 3 weeks, 3 months, 1 year post kidney transplant|"Per-protocol analysis; the number of samples obtained at each time point varied because not all subjects were able to undergo laboratory testing at the specified timepoints. The number of subjects samples per treatment group were as follows [Timepoint: Control(n)/Treatment(n)]:
Baseline: 43/41, Day 21: 44/41, Day 90: 44/43, Day 365: 44/43"||pg/mL||Full Range|Median
754904|NCT00587158|Secondary|Number of Subjects With Osteopenia/Osteoporosis of the Lumbar Spine at One Year|Osteopenia/Osteoporosis are conditions where bone mineral density is lower than normal, reported by T-scores, measurements of the lower spine made using an Dual Energy X-ray Absorptiometry (DEXA) scan. The T-score is measured and compared to a normal healthy adult. A normal bone density results in a T-score between +1.0 and -1.0. A T-score of less than or equal to -1.5 was used for this study to define the presence of osteopenia/osteoporosis. Each participant will be categorized as having or not having osteopenia/osteoporosis of the lumbar spine at the end of the first post-transplant year based on bone mineral density results.|1 year post kidney transplant|Per-protocol analysis; Data were not available for 1 subject from each arm because these subjects did not have the one year DEXA scan of the spine. [Control n = 43/Treatment n = 42].||Participants|||Number
754905|NCT00587158|Secondary|Number of Subjects With Osteopenia/Osteoporosis of the Hip at One Year|Osteopenia/Osteoporosis are conditions where bone mineral density is lower than normal, reported by T-scores, measurements of the hip made using an Dual Energy X-ray Absorptiometry (DEXA) scan. The T-score is measured and compared to a normal healthy adult. A normal bone density results in a T-score between +1.0 and -1.0. A T-score of less than or equal to -1.5 was used for this study to define the presence of osteopenia/osteoporosis. Each participant will be categorized as having or not having osteopenia/osteoporosis of the hip at the end of the first post-transplant year based on bone mineral density results.|1 year post kidney transplant|Per-protocol analysis. Data were not available for 2 control subjects and 2 treatment subjects, as these subjects did not have the DEXA scan of the hip done at one year. [Control n=42/ Treatment=41]||Participants|||Number
754906|NCT00587158|Primary|Number of Subjects With Hyperparathyroidism at One Year|Parathyroid hormone (PTH) is a measure of how well the parathyroid gland is working and is measured by a blood test. Hyperparathyroidism (increased PTH) is defined as PTH blood value greater than 65 picograms/milliliter in the absence of hypocalcemia (low calcium) or if the subject had a parathyroidectomy (surgical removal of parathyroid glands) during the first year post-transplant.|1 year post kidney transplant|Analysis was performed by the intention-to-treat principle, comprised of all subjects enrolled, who will have taken at least one dose of study medication and have both screening and any post-screening efficacy data recorded. The last observation was carried forward for missing values.||Participants|||Number
754907|NCT00587171|Secondary|Distribution of Change in Randot Preschool Steroacuity From Baseline to 17 Weeks|The Randot Preschool Stereotest measures stereopsis from 800 to 40 seconds of arc on patients as young as 2 years of age. This Stereotest is designed as a matching game in which the patient matches pictures in a test booklet wearing special glasses. A subject can fail the pretest (not see any pictures) or can score >800 (the worst), 800, 400, 200, 100, 60, or 40 (the best) seconds of arc. If two shapes are identified correctly the patient progresses to the next lower stereoacuity level. A failed test occurs when the patient cannot identify any shapes.|Baseline to 17 weeks|||participants|||Number
754908|NCT00587171|Secondary|Distribution of Randot Preschool Stereoacuity at 17 Weeks|The Randot Preschool Stereotest measures stereopsis from 800 to 40 seconds of arc. This Stereotest is designed as a matching game in which the patient matches pictures in a test booklet wearing special glasses. A subject can fail the pretest (not see any pictures) or can score >800 (the worst), 800, 400, 200, 100, 60, or 40 (the best) seconds of arc. If two shapes are identified correctly the patient progresses to the next lower stereoacuity level. A failed test occurs when the patient cannot identify any shapes.|17 weeks|||participants|||Number
754909|NCT00587171|Secondary|Mean (SD) of Change in Intereye Visual Acuity From Baseline to 17 Weeks|Visual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.|Baseline to 17 weeks|||letters||Standard Deviation|Mean
754910|NCT00587171|Secondary|Mean (SD) of Intereye Visual Acuity at 17 Weeks|Visual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.|17 weeks|||letters||Standard Deviation|Mean
754911|NCT00587171|Secondary|Mean (SD) of Change in Fellow Eye Visual Acuity From Baseline to 17 Weeks|Visual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.|Baseline to 17 weeks|||letters||Standard Deviation|Mean
754912|NCT00587171|Secondary|Distribution of Change in Fellow Eye Visual Acuity From Baseline to 17 Weeks|Visual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.|Baseline to 17 weeks|||participants|||Number
754913|NCT00587171|Secondary|Mean (SD) of Fellow Eye Visual Acuity at 17 Weeks|Visual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.|17 weeks|||letters||Standard Deviation|Mean
754915|NCT00587171|Primary|Mean (SD) of Change in Amblyopic Eye Visual Acuity From Baseline to 17 Weeks|Visual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.|Baseline to 17 weeks|||letters||Standard Deviation|Mean
754916|NCT00587171|Primary|Distribution of Change in Amblyopic Eye Visual Acuity From Baseline to 17 Weeks|Visual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.|Baseline to 17 weeks|||participants|||Number
754917|NCT00587171|Primary|Mean (SD): Distance Visual Acuity in Amblyopic Eye at 17-week Outcome|Visual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.|17 weeks|||letters||Standard Deviation|Mean
754918|NCT00587171|Primary|Distribution of Distance Visual Acuity in Amblyopic Eye at 17-week Outcome|Visual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.|17 weeks|||participants|||Number
754919|NCT00587223|Secondary|Proportion of Wounds Experiencing an Adverse Event||through 12 months|There was only 1 enrolled subject in the study; this endpoint was descriptively reported, no statistical analyses were performed.||proportion of treated wounds|||Number
754920|NCT00587223|Secondary|Reduction of Intensity of Pain||through 12 weeks|no analysis performed as only 1 subject enrolled||change in pain intensity between groups|||Number
754921|NCT00587223|Secondary|Recurrence of Epidermolysis Bullosa (EB) Lesions||through 12 months|no analysis performed as only 1 subject enrolled||proportion (%) of treated wounds|||Number
754922|NCT00587223|Secondary|Rate of Complete Wound Closure Over Time||through 12 weeks|no analysis performed as only 1 subject enrolled||change in area from baseline to Week 12|||Number
754923|NCT00587223|Secondary|Time Until Complete Closure||through 12 weeks|no analysis performed as only 1 subject enrolled||days|||Number
754924|NCT00587223|Primary|Proportion of Wounds First Achieving 100% Epithelialization of Tissue With the Absence of Drainage (i.e. Complete Wound Closure) Through Study Week 12||Through 12 weeks|no analysis performed as only 1 subject enrolled||proportion (%) of treated wounds|||Number
754925|NCT00587288|Secondary|Number of Participants With Treatment-emergent Adverse Events (AEs), Serious AEs, and AEs Leading to Study Discontinuation|Participants may have been included in more than 1 category. AEs summarized were those that began or worsened after dispensation of the study drug and before 30 days after the last dose of study drug. If the severity of an AE was missing, the AE was reported as “severe.” If drug relationship of an AE was missing, the AE was reported as “probably related.” WFT=withdrawn from treatment.|From start of study drug through 15 weeks + 30 days|ITT Analysis Set: all participants who received any amount of randomly assigned study drug with an assessment at Baseline and End of Therapy.||participants|||Number
754926|NCT00587288|Secondary|Percentage of Participants With Clinical Asthma Exacerbations (CAEs)|A CAE was defined as a 20% or more decrease in forced expiratory volume in 1 second (FEV1, absolute value) from the baseline value, a requirement for emergency treatment of asthma, hospital admission for asthma, or treatment with 3 or more days of oral corticosteroids for asthma worsening.|up to 15 weeks|ITT Analysis Set: all participants who received any amount of randomly assigned study drug.||percentage of participants|||Number
754927|NCT00587288|Secondary|Mean Change From Baseline to End of Therapy in Induced Sputum Eosinophil Levels||End of Screening or Baseline, End of Therapy (up to 15 weeks)|ITT Analysis Set: all participants who received any amount of randomly assigned study drug with an assessment at Baseline and End of Therapy.||percent change in eosinophil levels||Standard Deviation|Mean
754928|NCT00587288|Secondary|Change From Baseline to End of Therapy in Percent Predicted FEV1|The change in percent predicted FEV1 from baseline to End of Therapy was calculated from the FEV1 measured during pulmonary function tests using standard spirometry measurements. Each participant’s percent predicted FEV1 was calculated by adjusting the FEV1 for age, sex, height and race. The percent predicted FEV1 was then calculated by comparing the predicted FEV1 to the observed FEV1 using the Crapo formula (Crapo et al 1981a, Crapo and Morris 1981b, Crapo et al 1982).|Baseline, End of Therapy (up to 15 weeks)|ITT Analysis Set: all participants who received any amount of randomly assigned study drug with an assessment at Baseline and End of Therapy.||percent predicted FEV1||Standard Deviation|Mean
754929|NCT00587288|Secondary|Change From Baseline to End of Therapy in Forced Expiratory Volume in the First Second (FEV1)|The change in FEV1 from baseline to End of Therapy was determined. FEV1 was measured during pulmonary function tests using standard spirometry measurements.|Baseline, End of Therapy (up to 15 weeks)|ITT Analysis Set: all participants who received any amount of randomly assigned study drug with an assessment at Baseline and End of Therapy.||L||Standard Deviation|Mean
754930|NCT00587288|Secondary|Percentage of ACQ Responders at End of Therapy|Responders were defined as participants achieving at least a 0.5 reduction from baseline to End of Therapy in ACQ score. The ACQ is a 7 question instrument. Each question has 7 possible answers of 0, 1, 2, 3, 4, 5, and 6. Each increasing value is an indication of poorer asthma control. At protocol specified visits, the participant answered questions 1 to 6, circling the response that best described how that participant was during the past week, on the basis of a daily diary for the week before the visit. At the actual visit, study center personnel reviewed the questions and responses with the participant and determined the response and score for question 7. The overall ACQ score was presented as the mean of these 7 individual scores and was a number between 0 and 6, but not necessarily an integer.|Baseline, End of Therapy (up to 15 weeks)|ITT Analysis Set: all participants who received any amount of randomly assigned study drug.||percentage of participants|||Number
754984|NCT00587860|Secondary|Bowel Symptom Score (BSS) at 24 Weeks|The BSS is a five question, 100-mm visual analog scale of four IBS symptoms (pain/discomfort, bloating, constipation, and diarrhea), and an overall severity scale. The best possible value would be 0 (no symptoms) and the worst is 500 (severe symptoms). BSS was assessed on a bi-weekly basis.|24 weeks|||Units on a scale||Full Range|Median
754931|NCT00587288|Primary|Mean Change From Baseline to End of Therapy in Asthma Control Questionnaire (ACQ) Score|The ACQ is a 7 question instrument. Each question has 7 possible answers of 0, 1, 2, 3, 4, 5, and 6. Each increasing value is an indication of poorer asthma control. At protocol specified visits, the participant answered questions 1 to 6, circling the response that best described how that participant was during the past week, on the basis of a daily diary for the week before the visit. At the actual visit, study center personnel reviewed the questions and responses with the participant and determined the response and score for question 7. The overall ACQ score was presented as the mean of these 7 individual scores and was a number between 0 and 6, but not necessarily an integer.|Baseline through End of Therapy (up to 15 weeks)|Intent-to-treat (ITT) Analysis Set: all participants who received any amount of randomly assigned study drug.||units on a scale||Standard Deviation|Mean
754932|NCT00587431|Secondary|The Effects of Testosterone Administration on Docetaxel Pharmacokinetics.|Docetaxel Pharmacokinetic parameters for cycles 1 and 2.|at Cycle 1 and 2|A population pharmacokinetic model was fit to the data from all individuals simultaneously using a non-linear mixed effects modeling. This was performed using NONMEM. The NONMEM model accounts for between-patient, between-course, and residual variability (random effects) as well as parameter differences predicted by covariates (fixed effects).||L/hr||Standard Deviation|Mean
754933|NCT00587431|Primary|PSA of <_ 0.05 ng/ml After Radical Prostatectomy or Radiation Therapy and PSA <_ 2.0 ng/ml for Patients With Clinical Metastases Without Prior Definitive Therapy||Conclusion of the study (at 6 months then at 18 months post-treatment)|||participants|||Number
754934|NCT00587457|Secondary|Percentage Change From Baseline in Cluster of Differentiation 22 (CD22) Expression|Participants demonstrated CD22 expression on malignant cells at Screening and CD22 is a regulatory molecule that prevents the over activation of the immune system and the development of autoimmune diseases.|End of treatment (4-6 weeks after the last dose)|Safety population included all participants who received any treatment of moxetumomab pasudotox.||Percentage||Standard Deviation|Mean
754935|NCT00587457|Secondary|Number of Participants With Positive Neutralizing Antibodies|Participants tested for immunogenicity to moxetumomab pasudotox prior to enrollment, before each cycle and at end of study. The neutralization assay measures the capacity of participant's plasma (antibodies) to inhibit the binding of moxetumomab pasudotox to its target, cluster of differentiation 22 (CD22), coated onto enzyme linked immunosorbent assay (ELISA) plates. It was used as a direct surrogate for biological activity based on the mechanism of action of this drug. Significant level of neutralizing antibody activity defined as the capacity of test plasma to inhibit greater than (>)50 percentage (%) of the binding of CAT-8015 to CD22 using an ELISA-based method.|Up to end of treatment (4-6 weeks after the last dose)|Safety population included all participants who received any treatment of moxetumomab pasudotox.||Participants|||Number
754936|NCT00587457|Primary|Maximum Observed Serum Concentration (Cmax) for Moxetumomab Pasudotox|The Cmax is the maximum observed plasma concentration of Moxetumomab Pasudotox.|Predose, 0.25 (During Infusion), 0.5 (End of Infusion), 1, 1.5, 2, 4, 8 and 12 hours postdose on Day 1 and 5; Predose and End of Infusion on Day 3|Safety population included all participants who received any treatment of moxetumomab pasudotox. Here ‘n’ signifies participants evaluable for specified categories, for each arm, respectively.||nanogram per milliliter||Full Range|Median
754937|NCT00587457|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Moxetumomab Pasudotox|The Tmax is the time to reach maximum observed plasma concentration of Moxetumomab Pasudotox.|Predose, 0.25 (During Infusion), 0.5 (End of Infusion), 1, 1.5, 2, 4, 8 and 12 hours postdose on Day 1 and 5; Predose and End of Infusion on Day 3|Safety population included all participants who received any treatment of moxetumomab pasudotox. Here ‘n’ signifies participants evaluable for specified categories, for each arm, respectively.||hour||Full Range|Median
754938|NCT00587457|Primary|Best Overall Objective Tumor Response|Antitumor activity was assessed by best overall objective tumor response.|Up to 2 years of post-treatment follow-up|Safety population included all participants who received any treatment of moxetumomab pasudotox.||Participants|||Number
754939|NCT00587457|Primary|Number of Participants With Objective Response Rate (ORR): Complete Response (CR) or Partial Response (PR)|Objective response rate defined as the proportion of participants with confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria.|Up to 2 years of post-treatment follow-up|Safety population included all participants who received any treatment of moxetumomab pasudotox.||Participants|||Number
754940|NCT00587457|Primary|Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)|An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Treatment-emergent were events between first dose of study drug and 30 days after the last dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with grade 3 or higher treatment-emergent adverse events for laboratory abnormalities were reported as clinically relevant laboratory changes.|From start of study drug administration until 30 days after the last dose of study drug|Safety population included all participants who received any treatment of moxetumomab pasudotox.||Participants|||Number
754941|NCT00587457|Primary|Number of Participants With Clinically Relevant Electrocardiogram (ECG) Abnormalities Recorded as Adverse Events (AEs)|AEs observed in participants with clinically significant ECG abnormalities were assessed.|From start of study drug administration until 30 days after the last dose of study drug|Safety population included all participants who received any treatment of moxetumomab pasudotox.||Participants|||Number
754942|NCT00587457|Primary|Number of Participants With Vital Signs Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)|The vital sign abnormalities which require an action or intervention by the investigator, or a finding judged by the investigator were reported as an adverse event. TEAEs were events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug, for the period extending to 30 days after the last dose of study drug.|From start of study drug administration until 30 days after the last dose of study drug|Safety population included all participants who received any treatment of moxetumomab pasudotox.||Participants|||Number
755006|NCT00588146|Primary|Change in Hemoglobin|The hemoglobin level is expressed as the amount of hemoglobin in grams (gm) per deciliter (dL) of whole blood.|baseline, one year|Only 3 subjects completed the study, so the numbers were too low to analyze the study.|||||
754943|NCT00587457|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) events present at baseline that worsened in intensity after administration of investigational product or events absent at baseline that emerged after administration of study drug, for the period extending to 30 days after the last dose of study drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening situation (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received moxetumomab pasudotox. Treatment-emergent were events between administration of investigational product and Day 28 that were absent before treatment or that worsened relative to pretreatment state.|From start of study drug administration until 30 days after the last dose of study drug|Safety population included all participants who received any treatment of moxetumomab pasudotox.||Participants|||Number
754944|NCT00587483|Secondary|Time to Discharge From the Hospital||Participants were followed from the date of randomization until the date of discharge from the hospital, assessed up to 60 days.|||Days||Standard Deviation|Mean
754945|NCT00587483|Secondary|Time to Discharge From the Intensive Care Unit||Participants were followed from the date of randomization until the date of discharge from the Intensive Care Unit, assessed up to 40 days.|||Days||Standard Deviation|Mean
754946|NCT00587483|Secondary|Use of Vasopressors|Number of participants per arm who required the use of vasopressors in the post-operative period.|Participants were followed from randomization until time to discharge from the hospital.|||Participants|||Number
754947|NCT00587483|Secondary|Incidence of Arrhythmias in the Post-Operative Period|Number of participants per arm who experienced arrhythmias while on floor care following dismissal from the ICU.|Participants were followed from dismissal from the ICU until dismissal from the hospital.|||Participants|||Number
754948|NCT00587483|Secondary|Incidence of Arrhythmias Other Than Ventricular Fibrillation|Number of participants per arm who experienced arrhythmias other than ventricular fibrillation while in the ICU.|Participants were followed from randomization through the 60 minute period following myocardial reperfusion.|||Participants|||Number
754949|NCT00587483|Secondary|Number of Defibrillation Attempts||Participants were followed from randomization through the 60 minute period following myocardial reperfusion.|Intention to Treat (IIT)||Participants|||Number
754950|NCT00587483|Primary|Participants Experiencing Ventricular Fibrillation Requiring Defibrillation During the 60 Minute Period Following Myocardial Reperfusion||Participants were followed from randomization through the 60 minute period following myocardial reperfusion.|Intention to Treat (ITT)||Participants|||Number
754951|NCT00587587|Secondary|Decreased Utilization of Intralesional Steroid Intervention|The mean number of Intralesional (IL) Injections per participant is reported. A lower number of injections is a better outcome.|52 weeks|mITT population (randomized subjects only)||Injections per Participant||Standard Deviation|Mean
754952|NCT00587587|Secondary|Subject Global Assessment|Subject assessed using 5 point scale (1-excellent, 2-very good, 3-good, 4-moderate, 5-poor)|Week 52 or Last Visit|mITT population (randomized subjects only). Last Visit is the score recorded at last subject visit with non-missing data.||Participants|||Number
754953|NCT00587587|Secondary|Physician Global Assessment|Investigator assessed using 5 point scale (1-excellent, 2-very good, 3-good, 4-moderate, 5-poor)|Week 52 or Last Visit|mITT population (randomized subjects only). Last Visit is the score recorded at last subject visit with non-missing data.||Participants|||Number
754954|NCT00587587|Secondary|Degree of Recurrence (Scar Thickness)|Scar thickness measured by slide caliper in millimeters. A value of 0.0 mm on the slide caliper is equivalent to normal, non-hypertrophic/raised skin.|Week 52 or Last visit|mITT population (randomized subjects only). Last Visit is the score recorded at last subject visit with non-missing data.||mm||Standard Deviation|Mean
754955|NCT00587587|Secondary|Degree of Recurrence (Scar Firmness)|Scar firmness measured by Cutometer in millimeters.|Week 52 or Last Visit|mITT population (randomized subjects only). Last Visit is the score recorded at last subject visit with non-missing data.||mm||Standard Deviation|Mean
754956|NCT00587587|Secondary|Cumulative Incidence of Keloid Recurrence at Week 52|Recurrence is defined the first study visit at which the Investigator scores the Contour component of the BSS with a 4 (indicating a keloid). Contour is one of the five components measured in the BSS with Contour scores ranging from 1 (flush with surrounding skin) to 4 (keloid). Recurrence is a negative outcome.|52 weeks|Cumulative assessment, mITT population for randomized subjects only||participants|||Number
754957|NCT00587587|Secondary|Change in Degree of Keloid Recurrence as Measured by Beausang Scar Scale (BSS)|"Change in BSS cumulative score, Baseline to Last Visit, as reported by the Investigator, is reported.
BSS is a composite score where the individual scores from the following categories are summed:
Color (rated 1[perfect]-4[gross mismatch]), Shine (1/Matte or 2/Shiny), Contour (rated 1[flush with surrounding skin]-4[keloid]), Distortion (rated 1[None]-4[severe]), Texture (rated 1[normal]-4[hard]), and Overall Assessment on a 10cm visual analog scale (rated 0[excellent scar]-10 [poor scar]).
Total score ranges from 5 (clinically well healed scar) - 28 (clinically poor scar)."|Baseline to Week 52 or Last Visit|Modified ITT (mITT) for randomized subjects only. Last Visit is the score recorded at last subject visit with non-missing data.||Units on a scale||Standard Deviation|Mean
754958|NCT00587587|Primary|The Primary Purpose of This Study Will be to Gain Preliminary Safety Experience With Apligraf in the Keloid Indication. The Number of Participants Experiencing AEs is Presented.|"Summary of all reported adverse events (AE) in the intent to treat (ITT) population.
AE was defined as any adverse change in the subject’s medical status compared with the subject’s baseline condition, whether or not the event was related to the study device or a study procedure; or an exacerbation (either in frequency or severity) in a subject’s pre-existing condition. AE data were collected at every study visit or if volunteered by the subject at any time during the study."|52 weeks|ITT analysis per protocol. Report of at least 1 treatment emergent AE.||Participants|||Number
754959|NCT00587639|Secondary|Mean Level of Depression at Visit 30, as Measured by the Children's Depression Rating Scale, Revised (CDRS-R)|The Children's Depression Rating Scale, Revised (CDRS-R) is a validated, 17-item, clinician rating tool to assess severity of depression. Parents provide input into 14 of the items. Scores range from 0 to 60, with the following scale: not depressed (<20), borderline depressive symptoms (20-29), mild depression (30-39), moderate depression (40-59), severe depression (>/=60).|At study visit 30|||units on a scale||Standard Deviation|Mean
754960|NCT00587639|Primary|Change in Cognitive Status as Measured by the Children's Auditory Verbal Learning Test 2 (CAVLT-2)|The Children's Auditory Verbal Learning Test 2 (CAVLT-2) is a neuropsychological test that measures auditory verbal learning and memory. This test is designed for ages 6.6-17.11 years. Scores are reported as normalized standard scores. The minimum standard score is 60 and the maximum 140; a higher score indicates a better performance.|Pre-treatment (baseline visit) and post treatment (approximately 6-8 weeks after baseline visit)|||units on a scale||Standard Deviation|Mean
754961|NCT00587678|Secondary|V02 - Maximal Oxygen Consumption||2 years|||ml/min/kg||Standard Deviation|Mean
754962|NCT00587678|Secondary|6-minute Walk Distance||2 years|||ft.||Standard Deviation|Mean
754963|NCT00587678|Secondary|Log Treadmill Exercise Time||2 years|||log time in seconds||Standard Deviation|Mean
754964|NCT00587678|Secondary|Magnetic Resonance Angiographic Index|MRA index is a measure of angiographic severity of disease. 0 = no disease and 4 is severe disease.|2 years|||units on scale (0 = normal, 4 = worst)||Standard Deviation|Mean
754965|NCT00587678|Secondary|Triglycerides||2 years|||mg/dl||Standard Deviation|Mean
754966|NCT00587678|Secondary|High Density Lipoprotein Cholesterol||2 years|||mg/dl||Standard Deviation|Mean
754967|NCT00587678|Secondary|Total Cholesterol||2 years|||mg/dl||Standard Deviation|Mean
754968|NCT00587678|Primary|Phosphocreatine Recovery Time Constant - the Time it Takes for Phosphocreatine Levels to Recover to Plateau.|Phosphocreatine recovery time constant is the time it takes for phosphocreatine levels to recover to plateau after the completion of exercise. This ranges from 20 to 1000 seconds. 20-40 seconds is normal and any value over 40 seconds is abnormal.|2 years|||seconds||Standard Deviation|Mean
754969|NCT00587678|Primary|Perfusion Index|Perfusion index is a MRI measure of calf muscle perfusion indexed to the arterial input. The value is between 0 and 1 with 0 being worst and 1 being best.|2 years|||Units on a scale (0 = worst, 1 = best)||Standard Deviation|Mean
754970|NCT00587678|Secondary|Low Density Lipoprotein Cholesterol||2 years|||mg/dl||Standard Deviation|Mean
754971|NCT00587678|Primary|Plaque Volume|SFA plaque volume|2 years|||cm^3||Standard Deviation|Mean
754972|NCT00587769|Secondary|Point Prevalence Smoking Abstinence at 6 Months: the Number of Patients Who Refrained From Smoking at 6 Months|Smoking abstinence biochemically confirmed with exhaled carbon monoxide concentrations|6 months|||Participants|||Number
754973|NCT00587769|Primary|Point Prevalence Smoking Abstinence at 12 Weeks: the Number of Patients Who Refrained From Smoking at 12 Weeks|Smoking abstinence biochemically confirmed with exhaled carbon monoxide concentrations|12 weeks|||Participants|||Number
754974|NCT00587795|Primary|Change in Distal Radius Fracture at 8 Weeks|The investigators planned to make radiographic assessments using the Stewart Score. The Stewart Score can range from 1 to 12, with a higher score indicating poor function: excellent (0), good (1–3), fair (4–6) and poor (7–12).|baseline, 8 weeks||||||
754975|NCT00587834|Secondary|Pain Absent After 3 Days (Superiority)|Pain Assessment(Modified Intent-to-Treat Population)|Day 3||||||
754976|NCT00587834|Secondary|Surgical Site Sensitivity Mild or Absent After 1 Week(Superiority)|The sensitivity of Gintuit, Free Gingival Graft (FGG) and palatal donation sites was assessed with a puff of air and rated by the Investigator as none, mild, moderate or severe sensitivity. The sensitivity of Control was determined as the most sensitive of FGG and palatal donation sites.|6 months|See description in primary outcome measures. The presence of Coe-Pak (protective periodontal dressing) at Week 1 prohibited the assessment of sensitivity for 14 subjects. The analysis was performed on 71 of the 85 subjects evaluated for efficacy.||Participants|||Number
754977|NCT00587834|Secondary|Patient Preference After 6 Months/Early Termination (Superiority)|Number of patients expressing preference for Gintuit.|6 months|See description in primary outcome measure.||participants||95% Confidence Interval|Number
754978|NCT00587834|Secondary|Percentage of Subjects With at Least 1 mm Keratinized Tissue (KT) at 6 Months at the Gintuit Treated Site.|The superiority of Gintuit relative to a pre-defined standard (80% success) for a 1 mm KT threshold after six months.|6 months|See description in primary outcome measure.||Percentage of Participants||95% Confidence Interval|Number
754979|NCT00587834|Secondary|Texture Same as Adjacent Tissues After 6 Months (Superiority)|An examiner assessed texture of both treated sites compared with the adjacent, non-treated tissue. The assessment was recorded as “More Firm”, “Equally Firm”, or “Less Firm” as compared to adjacent, non-treated tissue. A match in texture with the surrounding tissue is considered a positive aesthetic outcome.|6 months|See description in primary outcome measures.||Participants|||Number
754980|NCT00587834|Secondary|Color Same as Adjacent Tissues After 6 Months (Superiority)|An examiner assessed color of both treated sites compared with the adjacent, non-treated tissue. The assessment was recorded as “More Red”, “Equally Red”, or “Less Red” as compared to adjacent, non-treated tissue. A match in color with the surrounding tissue is considered a positive aesthetic outcome.|6 months|See description in primary outcome measure.||Participants|||Number
754981|NCT00587834|Primary|Percentage of Subjects With at Least 2 mm Keratinized Tissue (KT) at 6 Months at the Gintuit Treated Site.|The superiority of Gintuit relative to a pre-defined standard (50% success) for a 2 mm KT threshold after six months.|6 months|Per protocol the first 2 subjects per Investigator were training subjects and evaluated for safety only. There were 11 training subjects and the remaining 85 subjects were analyzed for all efficacy outcomes.||percentage of participants||95% Confidence Interval|Number
754982|NCT00587847|Secondary|Rate of Infections|Number of participants who developed clinical or laboratory evidence of infection.|Weekly then every 2 weeks then every 3 weeks|All participants who received at least one dose of alemtuzumab were analyzed for safety.||participants|||Number
754983|NCT00587847|Primary|Time to Progression (Months)|Time to progression calculated as the period, in months, between the date of the first dose of alemtuzumab and the first date of documented disease progression (NCI 1996 criteria) or death. Duration of response of all other participants who did not progress nor expire, had their event times calculated at the last date of follow-up.|Every 8 weeks|All patients who were entered on study were analyzed according to NCI Working Group Response Criteria for CLL. Adverse events were graded on a scale of 1 to 4, where possible, according to the NCI Common Toxicity Criteria, Version 2.0.||months||Full Range|Mean
755325|NCT00593606|Primary|Change in Percentage of Basophilic Granulocytes in White Blood Cell Count|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||Percentage of white blood cell count||Standard Deviation|Mean
754985|NCT00587860|Secondary|Center for Epidemiologic Studies Depression Scale (CES-D) Score|We measured CES-D Score at baseline as well as bi-weekly throughout the study. The CES-D is a self-reported 20 question survey designed to measure depressive symptomatology in the general population. The possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology.|24 weeks|||Units on a scale||Full Range|Median
754986|NCT00587860|Secondary|IBS Symptoms Moderately or a Lot Better|Number of participants who stated their IBS symptoms were moderately better or a lot better at 24 weeks.|24 weeks|||participants|||Number
754987|NCT00587860|Secondary|Center for Epidemiologic Studies Depression Scale (CES-D) Score|We measured CES-D Score at baseline as well as bi-weekly throughout the study. The CES-D is a self-reported 20 question survey designed to measure depressive symptomatology in the general population. The possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology.|12 weeks|||Units on a scale||Full Range|Median
754988|NCT00587860|Secondary|Irritable Bowel Syndrome - Quality of Life (IBS-QoL) Score|The IBS-QOL is a self-report quality-of-life measure specific to Irritable Bowel Syndrome (IBS) that can be used to assess the impact of IBS and its treatment. The IBS-QOL was measured at baseline, week 12 and week 24. The individual responses to the 34 items are summed and averaged for a total score and then transformed to a 0-100 scale for ease of interpretation with higher scores indicating better IBS specific quality of life.|12 weeks of treatment|||Units on a scale||Full Range|Median
754989|NCT00587860|Secondary|Adequate Relief ≤ 50% During the Last 4 Weeks of Therapy|"Participants who reported yes or no to having adequate relief of their IBS symptoms at least 50% during the last 4 weeks of therapy."|Last 4 weeks of therapy|||Percentage of Participants|||Number
754990|NCT00587860|Secondary|Bowel Symptom Score (BSS) Amongst Subgroups|Median (average) BSS amongst the different IBS subgroups (diarrhea, constipation, pain, and bloating). The BSS is a 100-mm visual analog scale for the different symptoms of IBS (pain/discomfort, constipation, diarrhea, and overall severity). Symptoms on the BSS can range from 0 = no pain to 100 = extreme pain.|12 weeks|Analysis is based on the intention to treat (ITT) paradigm, including all randomized patients. Assuming standard deviation of the overall BSS symptom score is ~75, then 35 per group provides 80% power to detect about a 50% difference which is based on a 2-sample t-test assuming the distribution of Bowel Symptom Survey (BSS) values.||Scores on a scale||Full Range|Median
754991|NCT00587860|Primary|Overall Bowel Symptom Scores (BSS)|"The primary end point was the overall self-reported BSS after 12 weeks of therapy for all randomized participants to assess for differences between treatment groups at the end of the treatment period (12 weeks).
The BSS is a 100-mm visual analog scale for the different symptoms of IBS (pain/discomfort, constipation, diarrhea, and overall severity). Symptoms on the BSS can range from 0 = no pain to 100 = extreme pain."|After 12 weeks of treatment|Analysis is based on the intention to treat (ITT) paradigm, including all randomized patients. Assuming standard deviation of the overall BSS symptom score is ~75, then 35 per group provides 80% power to detect about a 50% difference which is based on a 2-sample t-test assuming the distribution of Bowel Symptom Survey (BSS) values.||Scores on a scale||Full Range|Median
754992|NCT00587964|Primary|Local Control|"following a combination of stereotactic radiosurgery and surgical resection for brain metastases; to determine the incidence of the brain injury following the combination therapy. Local control: Absence of radiographic evidence of tumor at the site of therapy constitutes local control of the treated disease.Recurrence in the treated region: The reappearance of tumor on any MRI or CT scan at the site of treatment constitutes recurrent disease at the treated region. Recurrence outside the treated region: The development of new intracranial metastatic foci or leptomeningeal disease constitutes recurrence outside the treated region. Leptomeningeal disease will be documented by a positive CSF cytology, abnormal myelogram or spinal MRI.
No evidence of disease: Absence of clinical or radiographic evidence of tumor both at the site of therapy and elsewhere in the brain constitutes no evidence of disease."|1 year|||participants|||Number
754993|NCT00587990|Secondary|Incidence of the Major Adverse Cardiac Events (MACE) Endpoint, Defined as the Composite Incidence of (1) Death, (2) Hospitalization for Heart Failure, or (3) Non-fatal Recurrent Heart Attack||Measured over the 6-month follow-up period and at Month 18 follow-up||||||
754994|NCT00587990|Secondary|Minnesota Living With Heart Failure (MLHF) Questionnaire||Measured over the 6-month follow-up period and at Month 18 follow-up||||||
754995|NCT00587990|Secondary|New York Heart Association (NYHA) Functional Class||Measured over the 6-month follow-up period and at Month 18 follow-up||||||
754996|NCT00587990|Secondary|Peak VO2 (by Treadmill Determination) and 6-minute Walk Test||Measured at baseline and Months 6 and 18 follow-ups||||||
754997|NCT00587990|Secondary|Serial Troponin and Creatine Kinase MB (CK-MB) Values||Measured every 12 hours for the first 48 hours after surgery||||||
754998|NCT00587990|Secondary|Cardiac Computed Tomography Measures of ISS, Left Ventricular Ejection Fraction, and End Diastolic and End Systolic Volumes||Measured over the 6-month follow-up period and at Month 18 follow-up||||||
754999|NCT00587990|Secondary|Pulmonary Function - Forced Expiratory Volume in 1 Second (FEV1) Results||Measured over the 6-month follow-up period and at Month 18 follow-up||||||
755000|NCT00587990|Secondary|Hematology, Clinical Chemistry, and Urinalysis Values||Measured over the 6-month follow-up period and at Month 18 follow-up||||||
755001|NCT00587990|Secondary|48-hour Ambulatory Electrocardiogram (ECG) Recordings||Measured over the 6-month follow-up period, at Month 12 follow-up and at Month 18 follow-up||||||
755002|NCT00587990|Secondary|Treatment Emergent Adverse Event Rates||Measured over the 6-month follow-up period, at Month 12 follow-up and at Month 18 follow-up||||||
755003|NCT00587990|Secondary|MRI and Echocardiographic Measures of Infarct Scar Size (ISS) and Left Regional and Global Ventricular Function||Measured over the 6-month follow-up period and at Month 18 follow-up||||||
755004|NCT00587990|Primary|Incidence of Serious Adverse Events (SAEs)|Incidence of serious adverse events (SAEs), defined as the 6-month post-cardiac surgery for coronary artery bypss grafting CABG SAE proportion of patients experiencing sustained ventricular arrhythmias, ectopic tissue formation, or sudden unexpected death|Measured at Month 6 after surgery|||percentage of patients||95% Confidence Interval|Number
755005|NCT00588094|Primary|Improve the Overall Response Rate|assessing the response rate (CR+PR)|2 years|||participants|||Number
756045|NCT00591344|Secondary|Time on the Timed up and go Test|This is the time it takes an individual to get up from a chair, walk 3 meters, turn around and walk back.|obtained during initial evaluation & then every 6 six months to end of 2-yr training period||||||
755007|NCT00588159|Secondary|Opioid Consumption in Second 24 Hour Hour Period (Hours 24-48) Postoperatively|Opioid equivalents (parenteral and/or oral) utilized by patient between hours 24-48 postoperatively|48 hours postoperatively|The number of participants analyzed included those who had successfully completed the protocol, by having received the study medication preoperatively, having received a functioning epidural prior to discharge from the postanesthesia care unit, and had a thoracotomy. Opioid use in mg is based on morphine equivalents (Hanks GW, Br J Cancer 2001).||mg||Standard Deviation|Mean
755008|NCT00588159|Primary|Average Pain Score With Coughing on Second Morning After Surgery|Numeric rating scale pain score with coughing on second morning after surgery, range 0-10.|Second morning after surgery|The number of participants analyzed included those who had successfully completed the protocol, by having received the study medication preoperatively, having received a functioning epidural prior to discharge from the postanesthesia care unit, and having undergone a thoracotomy.Numeric Rating Scale (NRS) ranges from 0 (no pain) to 10 (worst).||Unites on a scale||Standard Deviation|Mean
755009|NCT00588159|Primary|Average Pain Score With Coughing the First Morning Following Surgery|Patients were asked on the first morning following surgery how they rated their pain with coughing utilizing the Numeric Rating Scale for pain, with 0 being no pain and 10 being the worst pain imaginable. The range is 0-10.|First morning following surgery|The number of participants analyzed included those who had successfully completed the protocol, by having received the study medication preoperatively, having received a functioning epidural prior to discharge from the postanesthesia care unit, and having undergone a thoracotomy. Numeric Rating Scale (NRS) ranges from 0 (no pain) to 10 (worst).||Units on a scale||Standard Deviation|Mean
755010|NCT00588159|Secondary|Number of Participants With Pain at Thoracotomy Site 3 Months Postoperatively|Patients were contacted at 3 months post-thoracotomy and asked if they had pain at the thoracotomy site. We observed the number of participants with the presence of pain at thoracotomy site at 3 months postoperatively.|3 months postoperatively|The number of participants analyzed included those who had successfully completed the protocol, by having received the study medication preoperatively, having received a functioning epidural prior to discharge from the postanesthesia care unit, and had a thoracotomy. Patients who rated their average pain 1 or greater were included.||Participants|||Number
755011|NCT00588159|Secondary|Opioid Consumption in First 24 Hours Postoperatively||24 hours|The number of participants analyzed included those who had successfully completed the protocol, by having received the study medication preoperatively, having received a functioning epidural prior to discharge from the postanesthesia care unit, and had a thoracotomy. Opioid use in mg is based on morphine equivalents (Hanks GW, Br J Cancer 2001).||mg||Standard Deviation|Mean
755012|NCT00588159|Primary|Average Pain Score at Rest|Pain scores every 4 hours for 48 hours postoperatively, utilizing the numeric rating scale with 0 being no pain and 10 the most severe pain you can imagine.|48 hours|The number of participants analyzed included those who had successfully completed the protocol, by having received the study medication preoperatively, having received a functioning epidural prior to discharge from the postanesthesia care unit, and having undergone a thoracotomy. Numeric Rating Scale (NRS) ranges from 0 (no pain) to 10 (worst).||Units on a scale||Standard Deviation|Mean
755013|NCT00588237|Primary|Overall Objective Response|as determined by the GOG RECIST criteria|2 years|||participants|||Number
755014|NCT00588341|Primary|Overall Objective Response (Complete Response or Partial Response)|"The Response Evaluation Criteria in Solid Tumors (RECIST) will be used to determine treatment response.
Clinical Complete Response (CRc) Disappearance of all target lesions and non-measurable disease.
Pathological Complete Response (CRp) A CRc in which a lymph node dissection done after completing temozolomide treatment shows no pathological evidence of melanoma. Partial Response (PR) A greater or equal then 30% in the sum of the longest diameter of all target lesions relative to baseline measurement"|2 years|||participants|||Number
755015|NCT00588354|Secondary|Pain Score at 4 Weeks as Measured by the Multidimensional Pain Inventory (MPI)|The MPI is a comprehensive instrument comprised of 12 scales divided into three parts for assessing a number of dimensions of the chronic pain experience including pain intensity, emotional distress, cognitive and functional adaptation, and social support. Reference: Kearns RO, Turk DC, Rudy TC. The West Haven-Yale Multidimensional Pain Inventory (WHYMPI). Pain 1985; 23:345-356. Subscales were not used; the DOS WHYMPI computer program version 2.1 was used to score the instrument. Scores range from 0 (no pain) to 100 (highest pain). A score of 50 is the mean for patients with chronic pain.|4 weeks|||Units on a scale||Standard Deviation|Mean
755016|NCT00588354|Secondary|Pain Score at 2 Weeks as Measured by the Multidimensional Pain Inventory (MPI)|The MPI is a comprehensive instrument comprised of 12 scales divided into three parts for assessing a number of dimensions of the chronic pain experience including pain intensity, emotional distress, cognitive and functional adaptation, and social support. Reference: Kearns RO, Turk DC, Rudy TC. The West Haven-Yale Multidimensional Pain Inventory (WHYMPI). Pain 1985; 23:345-356. Subscales were not used; the DOS WHYMPI computer program version 2.1 was used to score the instrument. Scores range from 0 (no pain) to 100 (highest pain). A score of 50 is the mean for patients with chronic pain.|2 weeks|||Units on a scale||Standard Deviation|Mean
755017|NCT00588354|Secondary|Pain Disability Score at 4 Weeks as Measured by Oswestry Low Back Pain Disability Questionnaire|This questionnaire measures a patient's permanent functional disability. The questionnaire consists of 10 sections with 6 statements each of increasing point value (from 0 to 5). The score is a percentage of the total, with higher score showing greater disability. Minimum detectable change is 10%, with a 90% CI. Change of less than this may be attributable to error in measurement.|4 weeks|||Units on a scale||Standard Deviation|Mean
755018|NCT00588354|Secondary|Pain Disability Score at 2 Weeks as Measured by Oswestry Low Back Pain Disability Questionnaire (ODI)|This questionnaire measures a patient's permanent functional disability. The questionnaire consists of 10 sections with 6 statements each of increasing point value (from 0 to 5). The score is a percentage of the total, with higher score showing greater disability. Minimum detectable change is 10%, with a 90% CI. Change of less than this may be attributable to error in measurement.|2 weeks|Intention to Treat (ITT)||Units on a scale||Standard Deviation|Mean
755019|NCT00588354|Secondary|Pain Disability Score at 4 Weeks as Measured by the Roland-Morris Disability Questionnaire|This scale measures functional disability due to back pain. The score of the scale is the total number of items checked, from a minimum of 0 (no disability) to a maximum of 24 (great disability). Roland MO, Morris RW. A study of the natural history of back Pain. Part 1: development of a reliable and sensitive measure of disability in low back pain. Spine 1983; 8:141-144.|4 weeks|||Units on a scale||Standard Deviation|Mean
755020|NCT00588354|Secondary|Pain Disability Score at 2 Weeks as Measured by the Roland-Morris Disability Questionnaire|This scale measures functional disability due to back pain. The score of the scale is the total number of items checked, from a minimum of 0 (no disability) to a maximum of 24 (great disability). Roland MO, Morris RW. A study of the natural history of back Pain. Part 1: development of a reliable and sensitive measure of disability in low back pain. Spine 1983; 8:141-144.|2 weeks|||Units on a scale||Standard Deviation|Mean
755021|NCT00588354|Secondary|Pain Intensity Score at 2 Weeks as Measured by Pain Intensity Numerical Rating Scale (PI-NRS)|11-point ordinal scale measuring patient pain, ranging from 0 (no pain) to 10 (most severe/disabling pain).|2 weeks|Intention to Treat (ITT)||Units on a scale||Standard Deviation|Mean
755022|NCT00588354|Primary|Pain Intensity Score at 4 Weeks as Measured by Pain Intensity Numerical Rating Scale (PI-NRS)|11-point ordinal scale measuring patient pain, ranging from 0 (no pain) to 10 (most severe/disabling pain).|4 weeks|Intention to Treat (ITT)||Units on a scale||Standard Deviation|Mean
755023|NCT00581776|Secondary|3 Year Overall Survival (OS)|This is the percent of participants who were still alive at 3 years after study entry.|36 months|||Percent of participants||95% Confidence Interval|Number
755024|NCT00581776|Secondary|3 Year Progression Free Survival|This is the percent of subjects who had not had any recurrence or relapse of disease as of 3 years after enrollment in the study.|36 months|||percent of participants||95% Confidence Interval|Number
755025|NCT00581776|Primary|Complete Response Rate (CR) at the End of Induction Chemotherapy|Complete Response Rate (CRR) as defined by 1999 International Working Group criteria, is defined as patients with complete disappearance of disease, or regression of all lymph nodes to 1.5 cm in greatest diameter or less. All subjects who had completed 2 cycles of therapy and had at least one disease evaluation, or had completed 1 cycle of therapy with progressive disease, were considered evaluable.|at 21 weeks|||percent of participants||95% Confidence Interval|Number
755026|NCT00581776|Primary|Overall Response Rate (ORR) at the Completion of Induction Chemotherapy, Which is the Percent of Complete Responses (CR) Plus Percent of Partial Responses (PR).|"Patients were considered evaluable for response if they completed at least 2 cycles of therapy and had undergone an initial response evaluation, or had disease progression after 1 cycle of therapy.
1999 International Working Group criteria defines a CR as patients with complete disappearance of disease, or regression of all lymph nodes to 1.5 cm in greatest diameter or less. Partial Response indicates patients responded to treatment with a reduction in the amount of tumor (50 percent or more). Overall response rate is the percent of complete responses plus the percent of partial responses."|At completion of induction therapy (21 weeks)|||Percent of participants||95% Confidence Interval|Number
755027|NCT00581828|Primary|Change in Intestinal Calcium Absorption From Baseline to One Month|percent and true fractional calcium absorption|1 month|One subject's urine sample was mishandled, leaving 18 subjects with complete data for analysis.||percent calcium absorption||Standard Deviation|Mean
755028|NCT00581854|Primary|Complete Response Rate to Induction Therapy|Outcome is the % of subjects who achieved a Complete Response (CR) or Complete Response Unconfirmed (CRu) after induction therapy, following the Cheson et al criteria for standardized response criteria (1999).|Median follow up of 37 months|All Subjects enrolled were included in the analysis. Response rate is represented as % of total subjects enrolled.||percentage of participants||90% Confidence Interval|Number
755029|NCT00581867|Secondary|Global Cognition|Results derived from standardized z-score averaging performance across a battery of cognitive tests. The tests used include the Wechsler Memory Scale [WMS]-Revised Logical Memory I and II which measures a person's memory. Also used was the Wechsler Adult Intelligence Scale [WAIS] which measures intelligence in adults. The Trail Making A and B test was used to measure visual attention and task switching. The WAIS Block Design was done to test visuospatial and motor skills. The final test included in this measure is the Mini-Mental State Examination [MMSE]. The MMSE involves 30 questions and screens for cognitive impairment. Scores for each test were standardized to characterized individual global cognitive performance. The z-score reflects the standardized score. A positive z-score reflects a result above the average. A negative z-score reflects a result below the average.|90 mins|||z-scores||Standard Deviation|Mean
755030|NCT00581867|Primary|fMRI Measure of Hippocampal Activation|Percentage active voxels of total hippocampal volume of interest|30 minutes After Intervention Administration|||percentage of active voxels||Standard Deviation|Mean
755031|NCT00581919|Secondary|Progression-free Survival|Progression is defined as any of the following: 1) 25% or greater increase in M-protein as measured by serum or urine protein electrophoresis. There must be an absolute minimum increase of 0.5 g/dl in serum M spike or 0.2 gram of specific urinary light chains to constitute progression, 2) 25% or greater increase in the percentage or plasma cells in the bone marrow biopsy, or 3) new bone lesions or an increase in the size of old lesions on x-ray.|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 7 years.|||months||Full Range|Median
755032|NCT00581919|Secondary|Overall Survival||From date of randomization until the date of death from any cause, assessed up to 7 years|||months||Full Range|Median
755033|NCT00581919|Primary|Confirmed Anti-tumor Response Rate (Complete Response and Partial Response) to the Combination of Bortezomib, Dexamethasone, Doxorubicin, and ALCAR|"Anti-tumor responses were analyzed descriptively and summarized in tabular format. Ninety percent confidence intervals for the percentage of subjects with a confirmed anti-tumor response were constructed using the method proposed by Duffy-Santner.
Complete response defined as: no evidence of M-protein on immunofixation of serum and/or urine AND less than 5% plasma cells in the bone marrow biopsy.
Partial response defined as: 50 to 99% decrease in M-protein on serum and/or urine protein electrophoresis."|Every 21 days, up to 24 weeks|||percentage of participants||90% Confidence Interval|Number
755034|NCT00581945|Primary|Change From Baseline in Forced Expiratory Flow 25% to 75%|The forced expiratory flow (FEF) 25%-75% measurement describes the amount of air expelled from the lungs during the middle half (25% - 75%) of the forced vital capacity test and is measured using spirometry. A positive change from baseline in FEF indicates improvement in lung function.|Baseline, Week 25 and Week 45|Safety population||L/sec||Standard Deviation|Mean
755035|NCT00581945|Primary|Change From Baseline in Slow Vital Capacity (SVC)|Vital Capacity is the amount of air that can be forcibly exhaled from the lungs after a full inhalation. Slow Vital Capacity (SVC) test is performed by having the patient slowly and completely blow out all of the air from their lungs. A positive change from baseline in SVC indicates improvement in lung function.|Baseline, Week 25 and Week 45|Safety population||liters||Standard Deviation|Mean
755036|NCT00581945|Primary|Change From Baseline in Forced Vital Capacity (FVC)|Forced Vital Capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed by spirometry. A positive change from baseline in FVC indicates improvement in lung function.|Baseline, Week 25 and Week 45|Safety population||liters||Standard Deviation|Mean
755037|NCT00581945|Primary|Change From Baseline in Forced Expiratory Volume in 1 Second Percent Predicted|"The FEV1 percent predicted expresses FEV1 as a percentage of the predicted values for participants of similar characteristics (height, age, sex, and sometimes race and weight). A positive change from baseline in FEV1 % predicted indicates improvement in lung function."|Baseline, Week 25 and Week 45|Safety population||Percent of predicted||Standard Deviation|Mean
755038|NCT00581945|Secondary|Number of Participants Who Experienced Serious Adverse Events or Discontinued Due to Adverse Events|Safety was assessed by the number of participants with serious adverse events and/or adverse events leading to study discontinuation. A summary of adverse events is presented with this outcome, additional details are provided in the Adverse Events section.|Adverse events were collected during the 45 week treatment period and the 12 week follow-up period.|The safety population consisted of all randomized patients who received at least one dose of the study drug.||Participants|||Number
755039|NCT00581945|Primary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)|Forced expiratory volume in 1 second (FEV1) is the amount of air that can be exhaled in one second. FEV1 was measured by spirometry performed at approximately the same time of day on each visit to avoid diurnal variation. All spirometry calibrations and evaluations followed the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability. A positive change from baseline in FEV1 indicates improvement in lung function.|Baseline, Week 25 and Week 45|The safety population consisted of all randomized patients who received at least one dose of the study drug.||Liters||Standard Deviation|Mean
755040|NCT00581971|Primary|Response as Evaluated by Recurrence of Diseases|Evaluate the response to concurrent celecoxib, carboplatin, paclitaxel, and radiotherapy in the treatment of locally advanced SSC of the head and neck. Response is determined by local control only, local and distant metastasis, distant metastasis only, second primary, and surgical salvage.|2 years from end of treatment (Radiation therapy)|||Participants|||Number
755041|NCT00581971|Primary|Toxicity of Celecoxib With Concurrent Weekly Chemotherapy and Radiotherapy in the Treatment of Locally Advanced or Recurrent Squamous Cell Carcinoma of the Head and Neck.|Particpants experiencing Acute Toxicities > Grade 3|2 years from radiation therapy|||participants|||Number
755051|NCT00582036|Primary|Intensive Control of Glucose Effects on Mortality in Allogenic Hematopoietic Stem Cell Transplant (HSCT)||100 days|Due to early termination, data not analyzed||Participants|||Number
755052|NCT00582036|Secondary|Reduced Length of In-hospital Stay||About 100 days||||||
755053|NCT00582036|Secondary|Reduction of Infection||About 100 days||||||
755054|NCT00582075|Secondary|Overall Survival||2 years|||weeks||Full Range|Median
755055|NCT00582075|Primary|Percentage of Participants With Distant Brain Failure (DBF) at One Year|Patients developing distant brain failure (DBF) at one year. An approximation method was used to arrive at the reported percentage.|1 years|||percentage of participants|||Number
755246|NCT00593450|Secondary|Visual-acuity Score and Snellen Equivalent (Continuous)|"Visual acuity testing was performed with the Electronic Visual Tester (EVA) following the ETDRS protocol. VA score is measured as number of letters read correctly.
In this study, the outcome VA score is ranged from 0 to 97, with the higher score the better visual acuity."|at 1 Year|||No. of Letters||Standard Deviation|Mean
755056|NCT00582114|Other Pre-specified|Serious Adverse Events and Cardiovascular Events That Led to Trial Termination|Cardiovascular events were counted by subject and included the following: myocardial infarction (MI), stroke, hospitalization for congestive heart failure (CHF), hospitalized angina, arrhythmias, cardiac arrest, coronary revascularization and heart valve replacement. Adverse events reported are those during the course of 12 months of participation in the trial. All serious adverse events were adjudicated by R.A. and A.D.S. who were masked to the drug assignment at the time of adjudication. The duration of participation in the study per subject, which according to the trial design could be up to 12 months, was determined. The cardiovascular event rate was calculated by treatment group assignment. Incidence rate ratio (IRR) by treatment was then determined along with the 95% confidence intervals (95% CIs). As a post hoc analysis, we also determined the narrower definition of cardiovascular events per group that included MI, stroke, CHF, or cardiovascular death.|1 yr|||events/100 patient-years|||Number
755057|NCT00582114|Primary|The Primary End Point is the Regression of Left Ventricular Hypertrophy (LVH) by Echocardiographic Criteria From Baseline to 1 Year.|The primary outcome of the study was the average reduction in left ventricular mass indexed for body surface area from baseline to 1 year. A mixed model was used with left ventricular mass index (LVMI) as the outcome variable. Fixed effects were indicator variables for time, treatment and their interaction. Random effect was subject and statistical inference was made using the maximum likelihood estimator. No imputation was made for missing data.|Baseline, 6 months, 12 months|The primary outcome of the study was the average reduction in left ventricular mass indexed for body surface area from baseline to 1 year. The analysis was performed by intention to treat, if the patient received at least one dose of the randomized drug regardless of the availability of a post-baseline echocardiogram.||g/m^2||Standard Deviation|Mean
755058|NCT00582205|Secondary|Number of Patients With Dose Reductions or Dose Delays Due to Neuropathy or Toxicity||3 years|||Participants|||Count of Participants
755059|NCT00582205|Primary|Number of Patients Who Are Able to Receive 6 Cycles of Intraperitoneal Cisplatin Chemotherapy.||3 years|||Participants|||Count of Participants
755060|NCT00582309|Primary|Differences in Glycemic Control as Measured by Time Reach Glycemic Control for Each Treatment Group.|The protocol were compared by measuring in each patient time to acquire the Blood Glucose (BG) target range (80-120 mg/dl) defined by reaching a BG < 120, and maintaining the target range thereafter.|24 hours|||Time to reach glycemic control in hours||Standard Deviation|Mean
755061|NCT00582361|Primary|Infections|Number of acute, delayed and deep wound infections.|Up to 12 months|||Number of infections|||Number
755062|NCT00582361|Primary|Healing of Orthopaedic Trauma Open Fractures|Healing of the open wound following orthopaedic trauma open fracture surgery was measured in days. (The wound has healed adequately to permit closure)|from surgery to wound closure|||use days||Full Range|Mean
755063|NCT00582400|Secondary|Progression Free Survival|Time to progression from start of treatment|6 years|1 evaluable participant lost to follow up. No data collected.|||||
755064|NCT00582400|Secondary|Duration of Response.|Time to progression.|6 years|Participants with response||months||Full Range|Median
755065|NCT00582400|Primary|Number of Patients With Response to Treatment (RECIST Criteria)|Response included complete response, partial response or stable disease.|6 years|Participants who were evaluable for response||participants|||Number
755066|NCT00582400|Primary|Number of Participants With Treatment Related Toxicity.||6 years|||participants|||Number
755067|NCT00582426|Secondary|Change From Baseline in Quality of Life Measured by the Functional Assessment of Chronic Illness Therapy-Diarrhea (FACIT-D)|Quality of life (QoL) is evaluated using FACIT-D scale. FACIT-D is composed of 38 items, whose responses range from 0 to 4. The total FACIT-D score may range from 0 to 152. The 38 items compose five subscales, each evaluating a different component of the (QOL). For calculating the subscale score, some items are computed in a reverse fashion, so that higher FACIT-D scores indicate a better (QoL). Descriptive statistics (mean, standard deviation, median, minimum and maximum) are used to summarize FACIT-D scores (total and subscales) by study group at each time point.|Baseline to Day 168|ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer.||Units on a scale||Standard Deviation|Mean
755068|NCT00582426|Secondary|Percentage of Participants With Complete or Partial Response at Response Evaluation Criteria in Solid Tumors (RECIST)|Lesions that can be accurately measured in at least one dimension (longest diameter (LD) to be recorded) as > 20 mm with conventional techniques (CT, MRI) or as > 10 mm with spiral CT scan. All measurable lesions up to maximum of 5 lesions per organ and 10 lesions in total representative of all involved organs should be identified as target lesions and recorded and measured at baseline. Complete Response is defined as Disappearance of all target lesions. Partial Response is defined at least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD.|Day 56, Day 84, Day 112, Day 140, Day 168|"ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer. N in each category indicates the number of patients analyzed with observations at that timepoint."||Percentage of Participants||95% Confidence Interval|Number
755069|NCT00582426|Secondary|Percentage of Participants Who Need Intravenous Hydration for Control of Diarrhea||6 months overall|"ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer. 1 patient from the Octreotide Long Acting Release Arm discontinued due to exclusion criteria after visit 1."||Percentage of Participants||95% Confidence Interval|Number
755070|NCT00582426|Secondary|Percentage of Patients Hospitalized Due to Diarrhea||6 months overall|"ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer. 1 patient from the Octreotide Long Acting Release Arm discontinued due to exclusion criteria after visit 1."||Percentage of patients|||Number
755071|NCT00582426|Secondary|Percentage of Participants Who Need Opioids for Control of Diarrhea||6 months overall|"ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer. 1 patient from the Octreotide Long Acting Release Arm discontinued due to exclusion criteria after visit 1."||Percentage of Participants||95% Confidence Interval|Number
755072|NCT00582426|Secondary|Percentage of Participants Who Need Chemotherapy Dose Reduction Due to Diarrhea|For patient, chemotherapy dose reduction due to diarrhea as counted each time it occurred. Chemotherapy dose reduction because of other adverse events related to chemotherapy was not considered.|6 months overall|ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer. 1 patient discontinued from the Octreotide LAR arm due to exclusion criteria after visit 1.||Percentage of participants||95% Confidence Interval|Number
755073|NCT00582426|Secondary|Percentage of Episodes by Grade|Grade (severity)of episodes of diarrhea is evaluated by patient diaries recorded on a daily basis by considering only worse grade of diarrhea for each patient. Diarrhea was graded according to Common Toxicity Criteria where Grade 1 = Increase of <4 stools/day over pretreatment, Grade 2 = Increase of 4-6 stools/day, or nocturnal stools, Grade 3 = Increase of ≥7 stools/day or incontinence;or need for parenteral support for dehydration and Grade 4= Physiologic consequences requiring intensive care; or hemodynamic collapse.|6 months overall|ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer.||Percentage of Episodes|Participants||Number
755074|NCT00582426|Secondary|Percentage of Patients by Grade of Diarrhea|Grade (severity) of episodes of diarrhea is evaluated by patient diaries recorded on a daily basis by considering only worse grade of diarrhea for each patient. Diarrhea was graded according to Common Toxicity Criteria where Grade 0 = None, 1 = Increase of <4 stools/day over pretreatment, Grade 2 = Increase of 4-6 stools/day, or nocturnal stools, Grade 3 = Increase of ≥7 stools/day or incontinence; or need for parenteral support for dehydration and Grade 4= Physiologic consequences requiring intensive care; or hemodynamic collapse.|6 months overall|ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer. Patients with observations during overall treatment period were included in this analysis.||Percentage of Participants|||Number
755075|NCT00582426|Secondary|Number of Episodes of Diarrhea by Patient by Cycle|Mean number of episodes of diarrhea is evaluated by patient diaries recorded by cycle. (cycle 1 to cycle 7.)|at each cycle (28 days per cycle)|"ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer. n indicates patients with observations during each cycle."||Episodes/patient/cycle||Standard Deviation|Mean
755076|NCT00582426|Secondary|Number of Episodes of Diarrhea by Patient|Number of episodes of diarrhea is evaluated by patient diaries recorded on a daily basis.|6 months overall|ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer. Patients with observations during overall treatment period were included in this analysis.||Episodes/patients/day||Standard Deviation|Mean
755077|NCT00582426|Primary|Percentage of Participants Developing Diarrhea (Grade 1 to 4)|The percentage of patients developing diarrhea (incidence of grade 1 to 4) during treatment, considering only the worst grade of diarrhea for each patient. Diarrhea was graded according to Common Toxicity Criteria where Grade 0=None, 1 = Increase of <4 stools/day over pretreatment, Grade 2 = Increase of 4-6 stools/day, or nocturnal stools, Grade 3 = Increase of ≥7 stools/day or incontinence; or need for parenteral support for dehydration and Grade 4= Physiologic consequences requiring intensive care; or hemodynamic collapse.|6 month overall|"ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer. 1 patient from the Octreotide Long Acting Release Arm discontinued due to exclusion criteria after visit 1."||Percentage of Participants||95% Confidence Interval|Number
755078|NCT00582491|Secondary|Overall Sleep Quality on Visual Analog Scale (Millimeters)|"Upon awakening, participants rated their overall quality of sleep. Ratings were indicated by the participants marking an X on 100 mm lines (ie worse, best). The placement of the X was measured, using a ruler, to the nearest millimeter and thus ranged from 0 mm to 100 mm. Lower scores correspond to a worse quality of sleep and higher scores correspond to a better sleep quality.
Subjective measures from days 1 to 3, 7 to 9, and 14 to 16 were averaged to correspond to weeks 1, 2, and 3."|After 3 Weeks|The number of participants who completed the study were analyzed.||Millimeters||Standard Deviation|Mean
755079|NCT00582491|Secondary|Overall Sleep Quality on Visual Analog Scale (Millimeters)|"Upon awakening, participants rated their overall quality of sleep. Ratings were indicated by the participants marking an X on 100 mm lines (ie worse, best). The placement of the X was measured, using a ruler, to the nearest millimeter and thus ranged from 0 mm to 100 mm. Lower scores correspond to a worse quality of sleep and higher scores correspond to a better sleep quality.
Subjective measures from days 1 to 3, 7 to 9, and 14 to 16 were averaged to correspond to weeks 1, 2, and 3."|After 2 Weeks|The number of participants who completed the study were analyzed.||Millimeters||Standard Deviation|Mean
755080|NCT00582491|Primary|Time Spent in Sleep Stage 3 (Minutes)|Experimental polysomnographic sleep measurement was performed on the following three study night blocks: 1 to 3, 7 to 9, and 14 to 16. Data from each three-night block were averaged and reported as weeks 1, 2, and 3 respectively.|After 3 Weeks|The number of participants who completed the study were analyzed||Minutes||Standard Deviation|Mean
755081|NCT00582491|Primary|Time Spent in Sleep Stage 3 (Minutes)|Experimental polysomnographic sleep measurement was performed on the following three study night blocks: 1 to 3, 7 to 9, and 14 to 16. Data from each three-night block were averaged and reported as weeks 1, 2, and 3 respectively.|After 2 Weeks|The number of participants who completed the study were analyzed||Minutes||Standard Deviation|Mean
755082|NCT00582491|Primary|Time Spent in Sleep Stage 3 (Minutes)|Experimental polysomnographic sleep measurement was performed on the following three study night blocks: 1 to 3, 7 to 9, and 14 to 16. Data from each three-night block were averaged and reported as weeks 1, 2, and 3 respectively.|After 1 Week|The number of participants who completed the study were analyzed||Minutes||Standard Deviation|Mean
755247|NCT00593450|Secondary|Visual-acuity Score and Snellen Equivalent (Frequency)||at 1 Year|||Participants|||Number
756046|NCT00591344|Secondary|Modified Physical Performance Test|This is an overall measure of physical fuction|obtained during initial evaluation & then every 6 six months to end of 2-yr training period||||||
755083|NCT00582491|Primary|Total Sleep Time (Minutes)|"Total sleep time was defined as the time from sleep onset until final awakening minus the time awake after sleep onset.
Experimental polysomnographic sleep measurement was performed on the following three study night blocks: 1 to 3, 7 to 9, and 14 to 16. Data from each three-night block were averaged and reported as weeks 1, 2, and 3 respectively."|After 3 Weeks|The number of participants who completed the study were analyzed||Minutes||Standard Deviation|Mean
755084|NCT00582491|Primary|Total Sleep Time (Minutes)|"Total sleep time was defined as the time from sleep onset until final awakening minus the time awake after sleep onset.
Experimental polysomnographic sleep measurement was performed on the following three study night blocks: 1 to 3, 7 to 9, and 14 to 16. Data from each three-night block were averaged and reported as weeks 1, 2, and 3 respectively."|After 2 Weeks|The number of participants who completed the study were analyzed||Minutes||Standard Deviation|Mean
755085|NCT00582491|Secondary|Overall Sleep Quality on Visual Analog Scale (Millimeters)|"Upon awakening, participants rated their overall quality of sleep. Ratings were indicated by the participants marking an X on 100 mm lines (ie worse, best). The placement of the X was measured, using a ruler, to the nearest millimeter and thus ranged from 0 mm to 100 mm. Lower scores correspond to a worse quality of sleep and higher scores correspond to a better sleep quality.
Subjective measures from days 1 to 3, 7 to 9, and 14 to 16 were averaged to correspond to weeks 1, 2, and 3."|After 1 Week|The number of participants who completed the study were analyzed.||Millimeters||Standard Deviation|Mean
755086|NCT00582491|Primary|Total Sleep Time (Minutes)|"Total sleep time was defined as the time from sleep onset until final awakening minus the time awake after sleep onset.
Experimental polysomnographic sleep measurement was performed on the following three study night blocks: 1 to 3, 7 to 9, and 14 to 16. Data from each three-night block were averaged and reported as weeks 1, 2, and 3 respectively."|After 1 Week|The number of participants who completed the study were analyzed||Minutes||Standard Deviation|Mean
755087|NCT00582517|Primary|Knee Stability|The hypothesis of this study was that there would be equivalent final knee range of motion with fewer failures for ligament reconstructions following knee dislocations that were supplemented with the Compass Knee Hinge as compared to a control group.|12 months|||participants|||Number
755088|NCT00582556|Secondary|Number of Subjects With Decreases in Prostate Specific Antigen (PSA) After Zoledronic Acid Prior to Beginning Androgen Deprivation Therapy|"PSA response was measured by observing the serum PSA one week after beginning zoledronic acid and prior to beginning androgen deprivation therapy.
Arm 2 and Arm 3 were not able to be assessed for this endpoint as all subjects were on androgen deprivation prior to receiving zoledronic acid."|2 Years|||participants|||Number
755089|NCT00582556|Secondary|Number of Subjects Had a Significant Change in Immune Markers.|Immune markers were measured by isolating gamma-delta T cells one month after treatment with zoledronic acid.|2 Years|||participants|||Number
755090|NCT00582556|Secondary|The Number of Subjects Who Had a Significant Increase of Peripheral Blood Markers of Bone Turnover.|Serum bone-specific alkaline phosphatase was collected as the blood marker of bone turnover.|2 years|||participants|||Number
755091|NCT00582556|Primary|The Number of Subjects Who Had Either an Increase or Decrease on Bone Mineral Density of the Lumbar Spine and Femoral Neck in Men Undergoing Androgen Deprivation Therapy for Prostate Adenocarcinoma.|Effects on bone mineral density were measured at four locations at six month intervals for 24 months.|2 years|||participants|||Number
755092|NCT00582608|Primary|Safety and Toxicity is Measured by the Total Number of Participants Affected|Safety and toxicity is measured by the total number of participants affected. Please see the adverse event table for the specifics for this protocol.|2 years|||Participants|||Count of Participants
755093|NCT00588380|Secondary|Insulin Secretion at 210-240 Minutes|The 240 minute value represents the mean of values obtained at 210, 220, 230, and 240 minutes.|210 - 240 minutes after GLP-1 infusion|All participants completing the study.||10^-9 min^-1||Standard Error|Mean
755094|NCT00588380|Primary|Insulin Secretion at 150-180 Minutes.|The 180 minute value represents the mean of the values obtained at 150, 160, 170, and 180 minutes.|150 - 180 minutes after GLP-1 infusion|all participants completed the study||10^-9 min^-1||Standard Error|Mean
755095|NCT00588406|Secondary|Hospitalization||6 hours|||percentage of participants|||Number
755096|NCT00588406|Primary|FEV1 Percent Predicted||4 hours post-randomization|||percent predicted of FEV1||Standard Deviation|Mean
755097|NCT00588445|Secondary|Microarray Analysis to Identify Gene(s) or Gene Clusters That Exhibit Changes in Gene Expression; Time to Relapse and Overall Survival Data|Each patient provides two binary variables: presence/absence of mutation and responder/non responder. The association between the two will be tested using the Fisher's exact test for the resulting 2x2 table.Changes in expression levels within a patient will be assessed using a paired t-test. Similarly differences in expression levels between responders and non-responders will be assessed using a two-sample t-test. Appropriate adjustment will be made for the multiple comparisons problem that arises because there are over 21,000 probe sets on the U133A array.|2 years|||percentage of participants|||Number
755098|NCT00588445|Primary|The Radiographic Response to Gefitinib|Radiographic response is defined as a minor response ( > 25% decrease in the sum of the products of measured lesions)|21 days|||participants|||Number
755099|NCT00588471|Secondary|Change in Endothelial Peripheral Arterial Tomography (EndoPAT) Score After PCI|"The EndoPAT is a noninvasive test that involves putting probes on the index fingers of both hands and evaluating the blood flow to one hand before and after inflating a blood pressure cuff on one arm, temporarily reducing blood flow to the fingers. The finger sensor on the affected arm will now show no blood flow, while the sensor on the opposite index finger will continue to display your normal blood flow level. After several minutes, the blood pressure cuff is released, allowing blood to flow back into the affected lower arm. If the finger sensor on the affected arm shows a rush of blood, the blood vessels are functioning normally. If the blood flow return is sluggish, however, the blood vessels are unhealthy.
The results are reported as the Endoscore (range 0-3); a score of 1.67 and lower indicates the need for immediate medical attention; a score between 1.68 and 2 indicates a need to reduce risk factors; a score above 2.1 indicates a healthy heart."|baseline, within 24 hours post percutaneous coronary intervention|The study was terminated early because not enough subjects could be recruited.|||||
755295|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for ‘Cardiovascular’||28 days|Safety Set, only patients with non-missing values were analyzed||participants|||Number
755100|NCT00588471|Primary|Change in Serum High Sensitivity C-Reactive Protein (hsCRP)|"The hsCRP test evaluates vascular inflammation. People with higher hsCRP values have the highest risk of cardiovascular disease, and those with lower values have less of a risk. The American Heart Association and U.S. Centers for Disease Control and Prevention have defined risk groups as follows:
Low risk: less than 1.0 mg/L Average risk: 1.0 to 3.0 mg/L High risk: above 3.0 mg/L"|baseline, within 24 hours post percutaneous coronary intervention|The study was terminated early because not enough subjects could be recruited.|||||
755101|NCT00588536|Primary|Determine the Incidence of Complete and Partial Response and the Duration of Response in Patients With Langerhans Cell Histiocytosis (LCH) Treated With Sequential Administration of Oral 6-TG After MTX.||Conclusion of the study|||participants|||Number
755102|NCT00588640|Primary|Number Who Reached a Safe Dose|The number of patients who reached a safe and well tolerated dose of d-methadone|2 years|||participants|||Number
755103|NCT00588666|Secondary|The Response Rate of Combination Therapy With Bevacizumab, Gemcitabine, and Carboplatin in Patients With Advanced/Metastatic TCC.||3 years|||percentage of participants|||Number
755104|NCT00588666|Primary|Evaluate the Time to Disease Progression|Response and progression will be evaluated in this study using the international criteria by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI, 92(3):205-216, 2000]. Changes in only the largest diameter (uni-dimensional measurement) are used in the RECIST criteria.|3 years|||months||95% Confidence Interval|Median
755105|NCT00588692|Secondary|Change in Arterial Elastance|Elastance is a measure of the tendency of a hollow organ to recoil toward its original dimensions upon removal of a distending or compressing force. Effective arterial elastance was determined by the ratio of end systolic BP/stroke volume (SV).|baseline, 6 months|||mmHg/ml||Standard Deviation|Mean
755106|NCT00588692|Secondary|Change in Augmentation Index|"Aortic stiffness increases with aging, further augmenting cardiac load. One important repercussion of aortic stiffening is an increase in pulse wave velocity. As the outgoing pressure wave caused by ventricular ejection encounters zones of impedance mismatch, it is partially reflected backward, summing with the incident wave, to increase central aortic blood pressure. The magnitude of this systolic pressure wave reflection can be quantified by AIx.
Aortic pressures were assessed in the seated position after 5 minutes rest. Aortic pulse waveform analysis was performed using a noninvasive, high-fidelity hand held tonometer placed over the radial artery. The built-in, custom software was then used to convert radial pressure waveforms to central aortic waveforms, which more accurately reflect LV afterload. The ratio of this augmented pressure to aortic pulse pressure is defined as the augmentation index (AIx)."|baseline, 6 months|||percentage of change in AIx||Standard Deviation|Mean
755107|NCT00588692|Secondary|Change in Central Diastolic BP|Central blood pressure (CBP) is the pressure in the aorta, which is the large artery into which the heart pumps. This was determined by noninvasive radial tonometry, which undergoes transfer function using customized software to derive CBP tracings.|baseline, 6 months|||mmHg||Standard Deviation|Mean
755108|NCT00588692|Secondary|Change in Central Systolic BP|Central blood pressure (CBP) is the pressure in the aorta, which is the large artery into which the heart pumps. This was determined by noninvasive radial tonometry, which undergoes transfer function using customized software to derive CBP tracings.|baseline, 6 months|||mmHg||Standard Deviation|Mean
755109|NCT00588692|Secondary|Change in Brachial Diastolic BP|"Blood pressure is a measure of the force of the blood flowing against the walls of your arteries as it moves through your body.
There are two numbers in a blood pressure reading. This tells how high in millimeters the pressure of your blood raises a column of mercury. The numbers usually are expressed in the form of a fraction; an example of a blood pressure reading is 120/80 mm Hg. The first, or top, number (120 in the example) is the systolic pressure. The systolic pressure is the measure of your blood pressure as the heart contracts and pumps blood. The second or lower number is the diastolic pressure and is the measure taken when your heart is at rest (80 in the example)
Brachial diastolic BP was determined by a standard oscillometric device (Dinemap, Critikon)."|baseline, 6 months|||mmHg||Standard Deviation|Mean
755110|NCT00588692|Secondary|Change in Brachial Systolic Blood Pressure (BP)|"Blood pressure is a measure of the force of the blood flowing against the walls of your arteries as it moves through your body.
There are two numbers in a blood pressure reading. This tells how high in millimeters the pressure of your blood raises a column of mercury. The numbers usually are expressed in the form of a fraction; an example of a blood pressure reading is 120/80 mm Hg. The first, or top, number (120 in the example) is the systolic pressure. The systolic pressure is the measure of your blood pressure as the heart contracts and pumps blood. The second or lower number is the diastolic pressure and is the measure taken when your heart is at rest (80 in the example)
Brachial systolic BP was determined by a standard oscillometric device (Dinemap, Critikon)."|baseline, 6 months|||mmHg||Standard Deviation|Mean
755111|NCT00588692|Secondary|Change in Mitral E Wave Deceleration Time|The deceleration time (DT) is the time taken from the maximum E point to baseline. Normally in adults it is less than 220 milliseconds. The DT was measured by pulse wave doppler.|baseline, 6 months|||milliseconds (ms)||Standard Deviation|Mean
755112|NCT00588692|Secondary|Change in Mitral E/A Ratio|The E/A ratio is a marker of the function of the left ventricle of the heart; it is determined by echocardiography, an ultrasound-based cardiac imaging modality. Abnormalities in the E/A ratio on Doppler echocardiography suggest that the left ventricle, which pumps blood into the circulation, cannot fill with blood properly in the period between contractions. The E/A ratio is the ratio of peak early transmitral inflow velocity and peak late mitral inflow velocity.|baseline, 6 months|||ratio||Standard Deviation|Mean
755113|NCT00588692|Secondary|Change in Mitral E Velocity|The Mitral E velocity is the speed at which blood fills the ventricle. It is determined by echocardiography, an ultrasound-based cardiac imaging modality.|baseline, 6 months|||cm/sec||Standard Deviation|Mean
755114|NCT00588692|Secondary|Change in Stroke Volume|Stroke volume (SV) is the volume of blood pumped from one ventricle of the heart with each beat. SV was determined from pulse wave (PW) and continuous wave (CW) Doppler in the LV outflow tract.|baseline, 6 months|||ml||Standard Deviation|Mean
755128|NCT00592072|Primary|Digit Span Backward|The highest score is 35. The lowest score is 0. The higher the score indicates an improvement.|90 minutes|With the validation span test, a decrease in cognitive performance from euglycemia to hypoglycemia (22+/-2.3 vs 13.4+/-2.5) or a difference of 8.6 has been reported. Using this, a sample size of 12 will provide 80% power to detect a 23% (i.e. 2 unit) attenuation of the effect of hypoglycemia on cognitive performance.||units on a scale||Standard Error|Least Squares Mean
755115|NCT00588692|Secondary|Change in LV Ejection Fraction|"The ejection fraction is the percentage of the volume in the left ventricle ejected during a cardiac cycle. The normal ejection fraction is 55 to 75 percent. EF = (EDV ‑ ESV) / EDV where EF = ejection fraction, EDV = volume of blood in the left ventricle at end‑diastole, ESV = volume of blood in the left ventricle at end‑systole.
Ventricular Data was derived from comprehensive echo-Doppler/Tissue Doppler Echo (TDE) study performed at rest, during and immediately after exercise, along with noninvasive blood pressure assessment (GE Vivid7)."|baseline, 6 months|||percentage of LV blood volume||Standard Deviation|Mean
755116|NCT00588692|Secondary|Change in LV End Systolic Volume|"End-systolic volume (ESV) is the volume of blood in a ventricle at the end of contraction, or systole, and the beginning of filling, or diastole. ESV is the lowest volume of blood in the ventricle at any point in the cardiac cycle. End systolic volume can be used clinically as a measurement of the adequacy of cardiac emptying, related to systolic function.
Ventricular Data was derived from comprehensive echo-Doppler/Tissue Doppler Echo (TDE) study performed at rest, during and immediately after exercise, along with noninvasive blood pressure assessment (GE Vivid7). LV end systolic volumes was determined from the apical 4 and 2 chamber views using Simpson’s method of discs, along with EF."|baseline, 6 months|||ml||Standard Deviation|Mean
755117|NCT00588692|Secondary|Change in Left Ventricle (LV) End Diastolic Volume|"End-diastolic volume (EDV) is the volume of blood in the right and/or left ventricle at end load or filling in (diastole). An increase in EDV increases the preload on the heart and, through the Frank-Starling mechanism of the heart, increases the amount of blood ejected from the ventricle during systole (stroke volume).
Ventricular Data was derived from comprehensive echo-Doppler/Tissue Doppler Echo (TDE) study performed at rest, during and immediately after exercise, along with noninvasive blood pressure assessment (GE Vivid7). LV EDV was determined from the apical 4 and 2 chamber views using Simpson's method of discs, along with ejection fraction (EF)."|baseline, 6 months|||ml||Standard Deviation|Mean
755118|NCT00588692|Secondary|Change in Heart Rate||baseline, six months|||bpm||Standard Deviation|Mean
755119|NCT00588692|Primary|Change in Aortic Augmentation Index (AIx) According to Ejection Fraction Subgroups|"Aortic stiffness increases with aging, further augmenting cardiac load. One important repercussion of aortic stiffening is an increase in pulse wave velocity. As the outgoing pressure wave caused by ventricular ejection encounters zones of impedance mismatch, it is partially reflected backward, summing with the incident wave, to increase central aortic blood pressure. The magnitude of this systolic pressure wave reflection can be quantified by AIx.
Aortic pressures were assessed in the seated position after 5 minutes rest. Aortic pulse waveform analysis was performed using a noninvasive, high-fidelity hand held tonometer placed over the radial artery. The built-in, custom software was then used to convert radial pressure waveforms to central aortic waveforms, which more accurately reflect LV afterload. The ratio of this augmented pressure to aortic pulse pressure is defined as the augmentation index (AIx)."|baseline, 6 months|||percentage of change in AIx||Standard Deviation|Mean
755120|NCT00588692|Primary|Change in Peak Oxygen Uptake (VO2) During Maximal Effort Exercise Stress Test According to Ejection Fraction Subgroups|Peak oxygen uptake (VO2) is the maximum rate of oxygen consumption as measured during incremental exercise, most typically on a motorized treadmill. Maximal oxygen consumption reflects the aerobic physical fitness of the individual. VO2 data was obtained via standard breath-by-breath expired gas analysis. Ejection Fraction Subgroups are based on participants reported at baseline.|baseline, 6 months|For the EF subgroup 25-49%, n=48, 24 SphygmoCor Unblinded, 24 SphygmoCor Blinded. For the EF subgroup 35-49%, n=33, 14 SphygmoCor Unblinded,. 19 SphygmoCor Blinded. 2 subjects had EF either <25 or >50, and they were not included in the analysis.||percentage of change in Peak VO2||Standard Deviation|Mean
755121|NCT00592007|Secondary|Overall Survival||Patients will be followed until death|Subjects did not complete the study as planned. Zero participants analyzed due to termination of study. Data were not collected for this Outcome Measure. Outcomes were not collected due to withdrawal of the funding. Data not available.|||||
755122|NCT00592007|Primary|Progression-free Survival||14 weeks after start of fulvestrant|Subjects did not complete the study as planned. Zero participants analyzed due to termination of study. Data were not collected for this Outcome Measure. Outcomes were not collected due to withdrawal of the funding. Data not available.|||||
755123|NCT00592072|Primary|Telephone Search|This is a ratio of how many symbols are found during a certain period of time. The highest ratio is the best result.|90 minutes|With the validation span test, a decrease in cognitive performance from euglycemia to hypoglycemia (22+/-2.3 vs 13.4+/-2.5) or a difference of 8.6 has been reported. Using this, a sample size of 12 will provide 80% power to detect a 23% (i.e. 2 unit) attenuation of the effect of hypoglycemia on cognitive performance.||symbols/ 90 min||Standard Error|Least Squares Mean
755124|NCT00592072|Primary|Map Search (1min)|The highest score is 80. The lowest score is 0. Higher scores indicate an improvement.|90 minutes|With the validation span test, a decrease in cognitive performance from euglycemia to hypoglycemia (22+/-2.3 vs 13.4+/-2.5) or a difference of 8.6 has been reported. Using this, a sample size of 12 will provide 80% power to detect a 23% (i.e. 2 unit) attenuation of the effect of hypoglycemia on cognitive performance.||units on a scale||Standard Error|Least Squares Mean
755125|NCT00592072|Primary|Map Search (2min)|The highest score is 80. The lowest score is 0. Higher scores indicate an improvement.|90 minutes|With the validation span test, a decrease in cognitive performance from euglycemia to hypoglycemia (22+/-2.3 vs 13.4+/-2.5) or a difference of 8.6 has been reported. Using this, a sample size of 12 will provide 80% power to detect a 23% (i.e. 2 unit) attenuation of the effect of hypoglycemia on cognitive performance.||units on a scale||Standard Error|Least Squares Mean
755126|NCT00592072|Primary|Digit Symbol Coding|The highest score is 133. The lowest score is 0. Higher scores indicate an improvement.|90 minutes|With the validation span test, a decrease in cognitive performance from euglycemia to hypoglycemia (22+/-2.3 vs 13.4+/-2.5) or a difference of 8.6 has been reported. Using this, a sample size of 12 will provide 80% power to detect a 23% (i.e. 2 unit) attenuation of the effect of hypoglycemia on cognitive performance.||units on a scale||Standard Error|Least Squares Mean
755127|NCT00592072|Primary|Letter/Number Sequencing|The highest score is 21. The lowest score is 0. Higher scores indicate an improvement.|90 minutes|With the validation span test, a decrease in cognitive performance from euglycemia to hypoglycemia (22+/-2.3 vs 13.4+/-2.5) or a difference of 8.6 has been reported. Using this, a sample size of 12 will provide 80% power to detect a 23% (i.e. 2 unit) attenuation of the effect of hypoglycemia on cognitive performance.||units on a scale||Standard Error|Least Squares Mean
755129|NCT00592072|Primary|Verbal Memory Recognition|The highest score is 15. The lowest score is 0. Higher scores indicate an improvement.|90 minutes|With the validation span test, a decrease in cognitive performance from euglycemia to hypoglycemia (22+/-2.3 vs 13.4+/-2.5) or a difference of 8.6 has been reported. Using this, a sample size of 12 will provide 80% power to detect a 23% (i.e. 2 unit) attenuation of the effect of hypoglycemia on cognitive performance.||units on a scale||Standard Error|Least Squares Mean
755130|NCT00592072|Primary|Delayed Verbal Memory|The highest score is 25 and the lowest score is 0. The higher scored indicate an improvement.|90 minutes|With the validation span test, a decrease in cognitive performance from euglycemia to hypoglycemia (22+/-2.3 vs 13.4+/-2.5) or a difference of 8.6 has been reported. Using this, a sample size of 12 will provide 80% power to detect a 23% (i.e. 2 unit) attenuation of the effect of hypoglycemia on cognitive performance.||units on a scale||Standard Error|Least Squares Mean
755131|NCT00592072|Primary|Immediate Verbal Memory|Results of cognitive function in diabetic patients using tests such as digit symbol substitution (a test of memory), tests of everyday attention, telephone book searching and map searching during either administration of medium chain triglyceride oil or a control solution. The goal was to determine whether the human brain is able to use medium-chain fatty acids (MCFA) and /or their metabolites as an alternative fuel source and thus improve brain function during acute hypoglycemia in patients with type 1 diabetes. The lowest score is 0 and the highest score is 25. A higher score is an improvement.|90 minutes|With the validation span test, a decrease in cognitive performance from euglycemia to hypoglycemia (22+/-2.3 vs 13.4+/-2.5) or a difference of 8.6 has been reported. Using this, a sample size of 12 will provide 80% power to detect a 23% (i.e. 2 unit) attenuation of the effect of hypoglycemia on cognitive performance.||units on a scale||Standard Error|Least Squares Mean
755132|NCT00592124|Secondary|Grade 3 or Higher Toxicity for Systemic and Local Effects as Defined by the Protocol||Measured through Week 21|||Participants|||Count of Participants
755133|NCT00592124|Secondary|Reported Sharing of Product|Number and percentage of participants who had a product sharing event during the 6-week product use period, where a sharing event includes 1) being asked for the study product, or 2) selling, trading, or giving away study product, or 3) having someone take the study product from the participant.|Measured through Week 21|Participants who completed a product sharing assessment at the end of the 6-week product use period.||Participants|||Count of Participants
755134|NCT00592124|Secondary|Length of Time Vaginal Sexual Intercourse Took Place Before Using Gel.|Median and inter-quartile range of the time between product usage and instance of vaginal intercourse (given gel was used after the encounter).|Measured through Week 21|Last instances of vaginal sexual intercourse wherein gel was used after the encounters.||minutes|Sexual Encounters|Inter-Quartile Range|Median
755135|NCT00592124|Secondary|Gel Usage After Sex|These summaries represent counts and percentages of participants using gel after last instance of vaginal sex.|Measured through Week 21|Last instance of vaginal intercourse on the same day as gel use||Sexual Encounters|Sexual Encounters||Count of Units
755136|NCT00592124|Secondary|Length of Time Vaginal Sexual Intercourse Took Place After Using Gel.|Median and inter-quartile range of the time between product usage and instance of vaginal intercourse (given gel was used before the encounter).|Measured through Week 21|Last instances of vaginal sexual intercourse wherein gel was used before the encounters.||minutes|Sexual Encounters|Inter-Quartile Range|Median
755137|NCT00592124|Secondary|Gel Usage Before Sex|These summaries represent counts and percentages of participants using gel before last instance of vaginal sex.|Measured through Week 21|Last instance of vaginal intercourse on the same day as gel use||Sexual Encounters|Sexual Encounters||Count of Units
755138|NCT00592124|Secondary|Length of Time Vaginal Sexual Intercourse Took Place Before Using Tablet.|Median and inter-quartile range of the time between product usage and instance of vaginal intercourse (given tablet was used after the encounter).|Measured through Week 21|Last instances of vaginal sexual intercourse wherein tablets were used after the encounters. Timing data was not provided for two sexual encounters.||minutes|Sexual Encounters|Inter-Quartile Range|Median
755139|NCT00592124|Secondary|Tablet Usage After Sex|These summaries represent counts and percentages of participants using tablet after last instance of vaginal sex.|Measured through Week 21|Last instance of vaginal intercourse on the same day as tablet use||Sexual Encounters|Sexual Encounters||Count of Units
755140|NCT00592124|Secondary|Length of Time Vaginal Sexual Intercourse Took Place After Using Tablet.|Median and inter-quartile range of the time between product usage and instance of vaginal intercourse (given tablet was used before the encounter).|Measured through Week 21|Last instances of vaginal sexual intercourse wherein tablets were used before the encounters. Timing data was not provided for four sexual encounters.||minutes|Sexual Encounters|Inter-Quartile Range|Median
755141|NCT00592124|Secondary|Tablet Usage Before Sex|These summaries represent counts and percentages of participants using tablet before last instance of vaginal sex.|Measured through Week 21|Last instance of vaginal intercourse on the same day as tablet use||Sexual encounters|Sexual encounters||Count of Units
755142|NCT00592124|Secondary|Frequency of Male Condom Use||Measured through Week 21|||3-week periods|3-week periods||Count of Units
755143|NCT00592124|Secondary|Frequency of Sexual Activity|This represents the rate during the past 3 weeks at which participants engaged in vaginal sex.|Measured through Week 21|||3-week periods|3-week periods||Count of Units
755144|NCT00592124|Secondary|Proportion of Women Who Report Taking at Least 90% of Expected Daily Doses||Measured through Week 21|This outcome is based on evaluable participants.||Participants|||Count of Participants
755145|NCT00592124|Secondary|Number of Days Product Missed|This represents the longest number of days in a row during the past 3 weeks that a participant missed using the study product.|Measured through Week 21|This outcome is based on evaluable participants.||days|3-week periods|Standard Deviation|Mean
755146|NCT00592124|Secondary|Frequency of Product Use|This number represents how often participant used study product during the preceding 3 weeks and is measured twice during each 6 week product period.|Measured through Week 21|||3-week periods|3-week periods||Count of Units
755147|NCT00592124|Primary|Systemic and Local PK Among Three Regimens of Tenofovir (Oral, Vaignal, and Dual Use)|PK measures, including maximum concentrations (Cmax) in serum, tissue, and cervicovaginal lavage.|Measured through Week 21|Serum TFV and Tissue TFV measures do not include participants from South Africa clinical sites.||ng/mL, ng/mg, ng/mL||Inter-Quartile Range|Median
755148|NCT00592124|Primary|"Proportion of Participants Who Indicate They Would be Unlikely Use Study Product in the Future"||Measured through Week 21|||Participants|||Count of Participants
755149|NCT00592124|Primary|Self-reported Adherence to Each Regimen|Participant self-reported product use. For each woman, adherence to each regimen was computed by dividing the number of daily doses she reported having taken by the number of doses expect if she were fully adherent.|Measured through Week 21|For each woman, adherence to each regimen was computed by dividing the number of daily doses she reported having taken by the number of expected doses if she were fully adherent.||percentage of expected doses||Standard Deviation|Mean
755150|NCT00592176|Secondary|Number of Patients Having Surgical Removal of Pterygium.|The number of patients having surgical removal of pterygium within 12 months.|12 months|All subjects enrolled were analzyed.||Participants|||Number
755151|NCT00592176|Primary|The Area the Pterygium Enlarged or Regressed as Measured From the Limbus Before and After Subconjunctival Bevacizumab Injection.|"Growth of the pterygium was defined as an increase in the area of the pterygium as measured from the limbus toward the visual axis. This would be a positive change value indicating progression
Regression of the pterygium was defined as a decrease in the area of the pterygium length measured from the limbus toward the visual axis. This would be negative change value indicating regression."|Baseline and 3 months|All subjects enrolled were analzyed.||area in millimeters squared||Standard Deviation|Mean
755152|NCT00592319|Primary|Number of Case With Papilloma Recurrence During a 12-month Follow up|Criteria for the recurrence: the site scoring >4, plus visible lesion found in >50% of the treated tissue area, after surgery Description: The caculation of the site scoring is based on a called Derkay's scoring system: to indicate how many anatomic site involved, from the 0 (the best)to 13 (the worst),among a total of 13 laryngeal sites such as epiglottis or right true vocal cords.|12-month follow up|The paticipants for analysis were those who had the recurrence or completed follow-up period. The analysis was per protocol, and follow-up period was 12 months.||case|||Number
755153|NCT00592319|Secondary|Time Course (Month) With Papilloma Recurrence During 12-month Follow up|The measuer is reported as time course (i.e., how many month) to see papilloma recurrence if there is any such recurrence.|12 months|12-month follow-up||month||Full Range|Mean
755154|NCT00592358|Secondary|Change in Symptoms Measured by DSM-IV Mania Symptoms Checklist|A 13-item clinician-rated symptom checklist developed by Massachusetts General Hospital to measure symptoms of mania. Each item is given a rating for frequency (1=less than 4 days, 2=greater than or equal to 4 days, 3=daily) and intensity (1=mild, 2=moderate, 3=severe), which are combined to yield a composite severity score ranging from 0 (least severe) to 3 (most severe). The composite severity scores from all 13 items are summed to yield a total measure score, with a minimum score of 0 (least severe) and a maximum score of 39 (most severe).|Baseline and 8 weeks (or final study visit, if subjects completed the study before 8 weeks)|All participants for whom the mania checklist was available at both baseline and endpoint (8-weeks) were included in analyses.||units on a scale||Standard Deviation|Mean
755155|NCT00592358|Primary|Change in Symptoms Measured by Young Mania Rating Scale (YMRS)|The YMRS is an 11-item instrument used to assess the severity of mania in patients with a diagnosis of bipolar disorder. Four items are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven itemsare graded on a 0 to 4 scale. The maximum possible total score is 60 (worse outcome, severe symptoms), and the minimum possible total score is 0 (no symptoms).|Baseline and 8 weeks (or final study visit, if subjects completed the study before 8 weeks)|Participants exposed to study medication for a minimum of three weeks were included in analyses.||units on a scale||Standard Deviation|Mean
755156|NCT00592384|Primary|Hamilton Depression Rating Scale-Maier Subscale|The Maier is a 6-item sub scale of the Hamilton derived from Rasch analysis. It is a unidimensional scale with superior sensitivity to change. It excludes somatic items and is therefore especially appropriate for individuals who have substantial physical impairment and medical comorbidity. Scores can range from 0-22 with higher scores indicating more severe depression. Scores of 4 or less indicated in remission from depression.|0 weeks, 12 weeks|||units on a scale||Standard Deviation|Mean
755157|NCT00592384|Secondary|Hamilton Rating Scale for Anxiety||Weeks 0, 12||||||
755158|NCT00592384|Secondary|Patient Global Impression||Weeks 0, 1, 3, 6, 8, 10, 12||||||
755159|NCT00592384|Secondary|Clinical Global Impression||Weeks 0, 1, 3, 6, 8, 10, 12||||||
755160|NCT00592384|Secondary|Sheehan Disability Scale||Weeks 0, 12||||||
755161|NCT00592384|Secondary|Satisfaction With Life||Weeks 0, 12||||||
755162|NCT00592384|Secondary|Craig Handicap and Reporting Technique||Weeks 0, 12||||||
755163|NCT00592384|Secondary|Side Effects Checklist||Weeks 0, 1, 3, 6, 8, 10, 12||||||
755164|NCT00592384|Secondary|SF-12||Weeks 0, 12, 24||||||
755165|NCT00592384|Secondary|Structured Clinical Interview for DSM IV Depression Module||Weeks 0, 12, 24||||||
755166|NCT00592384|Secondary|Modified Ashworth Spasticity Scale||Weeks 0, 1, 3, 6, 8, 10, 12||||||
755167|NCT00592384|Secondary|Modified Brief Pain Inventory||Weeks 0, 1, 3, 6, 8, 10, 12||||||
755168|NCT00592384|Secondary|Symptom Checklist-20 Depression Subscale||Weeks 0, 1, 3, 6, 8, 10, 12, 24||||||
755169|NCT00592384|Primary|Hamilton Depression Rating Scale-17|The 17-item Hamilton Depression Rating Scale is a clinician rated measure of depression severity (we used a structured interview version (Williams 1988) to improve inter-rater reliability). Scores range from 0-52. Higher scores indicate more severe depression. Scores of 7 or less indicate remission from depression.|0 weeks, 12 weeks|||units on a scale||Standard Deviation|Mean
755170|NCT00592475|Secondary|Change From Baseline in Serum Sodium Levels at 0.5, 1, 2.5, 4, 6.5, 9, 12, and 24 Hours and on Day 8 Post Dose|"Baseline serum sodium value is the last measurement prior to dosing.
Change from baseline is calculated as time point minus baseline."|Baseline and 0.5, 1, 2.5, 4, 6.5, 9, 12, and 24 hours and on Day 8 post dose|"Participants Analyzed represents FAS: All randomized patients who had at least 1 dose of study drug & who had hepatic venous pressure gradient data at baseline.
The number of participants included in the calculation for each timepoint is noted in the category title."||mEq/L||Standard Deviation|Mean
755171|NCT00592475|Primary|Change From Baseline in Heart Rate at 0.5, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, 9, 12, and 24 Hours, and Day 8 Post Dose|"Change from baseline is calculated as time point minus baseline.
Baseline procedures were performed prior to study drug administration."|Baseline and 0.5, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, 9, 12, and 24 hours, and Day 8 post dose|"Population is Safety Analysis Set (SAF): All randomized patients who received at least one dose of study medication.
The number of participants per arm is consistent for all categories of the data table."||bpm||Standard Deviation|Mean
755172|NCT00592475|Primary|Change From Baseline in Blood Pressure at 0.5, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, 9, 12, and 24 Hours, and Day 8 Post Dose|"Change from baseline is calculated as time point minus baseline.
Baseline procedures were performed prior to study drug administration."|Baseline and 0.5, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, 9, 12, and 24 hours, and Day 8 post dose|"Population is Safety Analysis Set (SAF): All randomized patients who received at least one dose of study medication.
The number of participants per arm is consistent for all categories of the data table."||mmHg||Standard Deviation|Mean
755173|NCT00592475|Primary|Change From Baseline in Hepatic Mean Arterial Pressure (MAP) at 0.5, 1, and 1.5 Hours Post Dose|"Change from baseline is calculated as time point minus baseline.
Baseline procedures were performed prior to study drug administration."|Baseline and 0.5, 1, and 1.5 hours post dose|"Participants Analyzed represents FAS: All randomized patients who had at least 1 dose of study drug & who had hepatic venous pressure gradient data at baseline.
The number of participants included in the calculation for each timepoint is noted in the category title."||mmHg||Standard Deviation|Mean
755174|NCT00592475|Primary|Change From Baseline in Hepatic Blood Flow (HBF) at 0.5, 1, and 1.5 Hours Post Dose|"Change from baseline is calculated as time point minus baseline.
Baseline procedures were performed prior to study drug administration."|Baseline and 0.5, 1, and 1.5 hours post dose|Participants Analyzed represents FAS: All randomized patients who had at least 1 dose of study drug & who had hepatic venous pressure gradient data at baseline. (Note: 2 patients were not included in the analysis due to protocol deviations.) The number of participants included in the calculation for each timepoint is noted in the category title.||mL/min||Standard Deviation|Mean
755175|NCT00592475|Primary|Change From Baseline in Hepatic Venous Pressure Gradient (HVPG) at 0.5, 1, and 1.5 Hours Post Dose|"Change from baseline is calculated as time point minus baseline.
Baseline procedures were performed prior to study drug administration."|Baseline and 0.5, 1, and 1.5 hours post dose|"Participants Analyzed represents Full Analysis Set (FAS): All randomized patients who had at least 1 dose of study drug & who had hepatic venous pressure gradient data at baseline.
The number of participants per arm is consistent for all categories of the data table."||mmHg||Standard Deviation|Mean
755176|NCT00592488|Secondary|Serum Lactate||12-36 hours||||||
755177|NCT00592488|Primary|Vasopressor Dose||6-24 hours||||||
755178|NCT00592488|Primary|Mean Arterial Blood Pressure|Mean Arterial blood pressure measured non-invasively at 18 hours|18 hours|All patients treated. Intention to treat.||units on a scale|Participants|Standard Error|Mean
755179|NCT00592631|Primary|Change in Provocative Concentration of Methacholine Causing a 20% Fall in Forced Expiratory Volume in 1 Second (FEV1)|Methacholine is an inhaled medication used to assess asthma and reactive airways. It was given at increasing concentrations (beginning with 0.0625 mg/ml and ending with 16.0 mg/ml). Each dose was followed by a lung measurement until a change of FEV1 of 20% occurs or until a maximum dose was reached, whichever came first.|7 to 10 nights after cpap is started.|||log mg/ml||Standard Error|Mean
755180|NCT00592683|Secondary|DSM-IV Mania Symptom Checklist|The DSM-IV Mania Symptom Checklist is used to evaluate symptoms of mania. Item scores range from 0-3, with larger scores indicating greater severity. With 33 items, the maximum (most severe) score possible is 99, with the minimum (least severe) score possible being 0.|weekly for first 6 weeks then biweekly|14 subjects came in for week 12 assessments - included in final analysis.||units on a scale||Standard Deviation|Mean
755181|NCT00592683|Primary|Change in Bipolar Symptoms as Assessed by Young-Mania Rating Scale (YMRS)|The YMRS is used to evaluate symptoms of mania in children and adolescents. Items are rated from 0-4 or 0-8, with higher scores indicating greater severity. The minimum total score (least severe) is 0, and the maximum total score (most severe) is 60.|weekly for 1st 6 weeks then biweekly|14 subjects came in for week 12 assessments - included in final analysis.||Units on a scale||Standard Deviation|Mean
755182|NCT00592761|Primary|Change in Duration of Hyoid Maximum Anterior Excursion|Change in the duration of maximum anterior movement of the hyoid bone during swallowing.|Baseline and 6 weeks|||seconds||Standard Deviation|Mean
755183|NCT00592761|Secondary|Change in Duration of Opening of Upper Esophageal Sphincter|Change in duration of pre- and post-treatment duration of UES opening.|Baseline and 6 weeks|||seconds||Standard Deviation|Mean
755184|NCT00592761|Secondary|Change in Oral Intake Ability|Oral Intake Ability was measure with the Dysphagia Outcome and Severity Scale. A 7 is normal and a 1 is complete inability to consume any food safely. The means reported for treatment and no treatment periods are mean changes in scores throughout the period.|Baseline and 6 weeks|||units on a scale||Standard Deviation|Mean
755185|NCT00592761|Primary|Change in Duration of Superior Hyolaryngeal Movement|Change in duration of superior elevation of hyoid bone.|baseline and six weeks|per protocol||seconds||Standard Deviation|Mean
755186|NCT00592774|Secondary|Analysis of Allodynia (Present/Not Present) at Week 15/EOT– by Treatment Groups ITT Population (Modified BOCF)|Allodynia is defined as a painful reaction to a non-painful stimulus.|Week 15|ITT population (Modified BOCF)||Participants|||Number
755187|NCT00592774|Secondary|Change From Baseline to Week 15/EOT in HADS Depression Subscale Scores (Modified BOCF)|The HADS (Hospital Anxiety and Depression Scale) is a widely used, self-reported, 14-item instrument that measures the presence and severity of anxiety and depression. It consists of 2 subscales; a 7-item anxiety subscale (HADS-A) and a 7-item depression subscale (HADS-D). HADS-D consists of a 7-item scale, each scored on a 4-pt scale (0, 1, 2, or 3), where a higher score indicates worse depression. Range of possible HADS depression subscale scores is 0 to 21, and normal=(0-7), mild=(8-10), moderate=(11-14), and severe=(15-21).|Baseline and Week 15|ITT population (Modified BOCF)||Scores on a scale||Standard Deviation|Mean
755188|NCT00592774|Secondary|Change From Baseline to Week 15/EOT in HADS Anxiety Subscale Scores (Modified BOCF)|The HADS (Hospital Anxiety and Depression Scale) is a widely used, self-reported, 14-item instrument that measures the presence and severity of anxiety and depression. It consists of 2 subscales; a 7-item anxiety subscale (HADS-A) and a 7-item depression subscale (HADS-D). HADS-A consists of a 7-item scale, each scored on a 4-pt scale (0, 1, 2, or 3), where a higher score indicates worse anxiety. Range of possible HADS anxiety subscale scores is 0 to 21, and normal=(0-7), mild=(8-10), moderate=(11-14), and severe=(15-21).|Baseline and Week 15|ITT population (Modified BOCF)||Scores on a scale||Standard Deviation|Mean
755296|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for ‘Dermatological’||28 days|Safety Set, only patients with non-missing values were analyzed||participants|||Number
755189|NCT00592774|Secondary|Clinician Global Impression of Change (CGIC) at Week 15/EOT|Changes were calculated using the modified BOCF method|Week 15|Subset of ITT population used, including subjects that completed CGIC at Week 15 visit, and using BOCF (baseline observation carried forward) subjects that terminated prior to Week 15 received a 'No Change' if due to AE or Lack of Therapeutic Efficacy, subjects who discontinued due to other reasons used CGIC scores from Early Termination visit.||Participants|||Number
755190|NCT00592774|Secondary|Patient Global Impression of Change (PGIC) at Week 15/EOT|Changes were calculated using the modified BOCF method|Week 15|Subset of ITT population used, including subjects that completed PGIC at Week 15 visit, and using BOCF (baseline observation carried forward) subjects that terminated prior to Week 15 received a 'No Change' if due to AE or Lack of Therapeutic Efficacy, subjects who discontinued due to other reasons used PGIC scores from Early Termination visit.||Participants|||Number
755191|NCT00592774|Secondary|Change From Baseline to Week 15/EOT in Average Sleep Interference Scores|The average of the last 7 available sleep scores prior to the visit, based on the 11-point Likert-type numerical rating scale for sleep interference (where 0=pain did not interfere with sleep, to 10=pain completely interfered with sleep [unable to sleep]), and they were reported by treatment group.|Baseline and Week 15|ITT Population (Modified BOCF)||Scores on a scale||Standard Deviation|Mean
755192|NCT00592774|Primary|Change From Baseline in Average Pain Scores by Week|Change from baseline in average pain scores by week based on pain intensity (11‑point Likert‑type numerical scale where 0=no pain and 10=worst possible pain), reported by the subjects in a daily diary. The average pain scores were calculated as the average of available scores in each week, and were reported by treatment group.|Week 1 through Week 16|ITT Population||Scores on a scale||Standard Deviation|Mean
755193|NCT00592774|Primary|Responder Rate: Subjects With at Least 50 Percent Reduction in Pain|A responder was a participant with at least 50 percent reduction in average pain scores, using modified BOCF, based on pain intensity (11‑point Likert‑type numerical scale where 0=no pain and 10=worst possible pain), reported by the subjects in a daily diary. The average pain score for baseline was calculated using the average of the last 7 scores prior to randomization, and the average pain score for Week 15 was computed using the average of the last 7 on‑treatment scores prior to Week 15, and they were reported by treatment group.|Baseline and Week 15|ITT Population (Modified BOCF)||Percentage of Participants|||Number
755194|NCT00592774|Primary|Responder Rate: Subjects With at Least 30 Percent Reduction in Pain|A responder was a participant with at least 30 percent reduction in average pain scores, using modified BOCF, based on pain intensity (11‑point Likert‑type numerical scale where 0=no pain and 10=worst possible pain), reported by the subjects in a daily diary. The average pain score for baseline was calculated using the average of the last 7 scores prior to randomization, and the average pain score for Week 15 was computed using the average of the last 7 on‑treatment scores prior to Week 15, and they were reported by treatment group.|Baseline and Week 15|ITT Population (Modified BOCF)||Percentage of Participants|||Number
755195|NCT00592774|Primary|Change From Baseline in Average Pain Scores to Week 15/ End of Treatment (EOT) (Including Modified BOCF Data)|Average pain scores are based on pain intensity (11‑point Likert‑type numerical scale, where 0=no pain and 10=worst possible pain), reported by the subjects in a daily diary. The average pain score for baseline was calculated using the average of the last 7 scores prior to randomization, and the average pain score for Week 15 was computed using the average of the last 7 on‑treatment scores prior to Week 15, and they were reported by treatment group.|Baseline and Week 15|Intent‑to‑Treat (ITT) Population- group of subjects who were randomized, took study drug, and had at least 1 efficacy assessment at Baseline. The modified Baseline Observation Carried Forward (BOCF) method was used.||Scores on a scale||Standard Deviation|Mean
755196|NCT00592839|Secondary|Mean Change in Biochemical Markers of Bone Metabolism (Sex Hormone Binding Globulin).|Change= Week 12 biochemical markers of bone metabolism (Sex Hormone Binding Globulin) - Baseline biochemical markers of bone metabolism values for the intent-to-treat cohort.|Baseline to End of Treatment (12 weeks)|"Participants analyzed consisted of subjects from the ITT cohort, defined as all subjects who were exposed to investigational product therapy and who provided baseline sleep time hot flash information and sleep time hot flash data for at least one post-baseline visit. Not all study subjects completed all data elements in their study diaries."||nmol/L||Standard Deviation|Median
755197|NCT00592839|Secondary|Mean Change in Biochemical Markers of Bone Metabolism (Osteocalcin)|Change= Week 12 biochemical markers of bone metabolism (Osteocalcin) - Baseline biochemical markers of bone metabolism values for the intent-to-treat cohort.|Baseline to End of Treatment (Week 12)|"Participants analyzed consisted of subjects from the ITT cohort, defined as all subjects who were exposed to investigational product therapy and who provided baseline sleep time hot flash information and sleep time hot flash data for at least one post-baseline visit. Not all study subjects completed all data elements in their study diaries."||ng*ml||Standard Deviation|Mean
755198|NCT00592839|Secondary|Mean Change in Biochemical Markers of Bone Metabolism (N-telopeptide).|Change= Week 12 biochemical markers of bone metabolism (N-telopeptide) - Baseline biochemical markers of bone metabolism values for the intent-to-treat cohort.|From baseline to End of Treatment (Week 12)|"Participants analyzed consisted of subjects from the ITT cohort, defined as all subjects who were exposed to investigational product therapy and who provided baseline sleep time hot flash information and sleep time hot flash data for at least one post-baseline visit. Not all study subjects completed all data elements in their study diaries."||nM BCE||Standard Deviation|Mean
755199|NCT00592839|Secondary|Mean Change in Stanford Sleepiness Scale|Change= Week 12 score - Baseline Score. Daytime sleepiness was derived from the subject self-assessment how they felt at a particular time of day. Subjects rated daytime sleepiness on the 7 point Stanford Sleepiness Scale (1=most alert to 7=sleepiest).|Baseline to End of Treatment (Week 12)|"Participants analyzed consisted of subjects from the ITT cohort, defined as all subjects who were exposed to investigational product therapy and who provided baseline sleep time hot flash information and sleep time hot flash data for at least one post-baseline visit. Not all study subjects completed all data elements in their study diaries."||Score on Scale||Standard Error|Least Squares Mean
755212|NCT00593112|Primary|H MRS Scan Results - Glutamate & Glutamine (Glx)/Ino|"Comparison of treated ADHD participants (6 weeks on Concerta) and Healthy Control Subjects (HCS)
This measure is a ratio of Glutamate and it's precursor, Glutamine, to myo-inositol (cyclic sugar alcohol) containing compounds in the anterior cingulate."|after 6 weeks Concerta treatment|Seven subjects who completed the protocol were not included due to a lack of baseline comparison.||MRS Ratio||Standard Deviation|Mean
755200|NCT00592839|Secondary|Mean Change in Individual Sleep Parameters on a Three-point Scale|Change= Week 12 weekly average sleep quality score - Baseline weekly average sleep quality score for the intent-to-treat cohort. The sleep quality was derived from the subject self-assessment of sleep quality graded on a three-point scale (3=excellent, 2=good, 1=poor sleep quality)|Baseline to End of Treatment (Week 12)|"Participants analyzed consisted of subjects from the ITT cohort, defined as all subjects who were exposed to investigational product therapy and who provided baseline sleep time hot flash information and sleep time hot flash data for at least one post-baseline visit. Not all study subjects completed all data elements in their study diaries."||scores on a scale||Standard Error|Least Squares Mean
755201|NCT00592839|Primary|Mean Change in Average Frequency of Awakenings Due to Sleep-time Hot Flashes|Change= Week 12 weekly average awakening score - Baseline weekly average awakening score for the intent-to-treat cohort|Baseline to End of Treatment (Week 12)|"Participants analyzed consisted of subjects from the intent-to-treat (ITT) cohort, [all subjects who were exposed to investigational product therapy,provided baseline sleep time hot flash information and sleep time hot flash data for at least one post-baseline visit]. Not all study subjects completed all data elements in their study diaries."||Awakenings||Standard Error|Least Squares Mean
755202|NCT00592852|Secondary|Young Mania Rating Scale (YMRS)|This scale measures mania symptoms in children and adolescents using 11 items rated from 0 (least severe) to 4 (most severe), although 4 items are rated from 0-8. The minimum (least severe) possible score is 0, and the maximum (most severe) possible score is 60.|weekly|2 participants were not included in final analysis - 1 terminated at 1 week due to non-compliance with taking study medication. 1 found ineligible prior to beginning treatment.||Units on a scale||Standard Deviation|Mean
755203|NCT00592852|Primary|Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)|This sale measures impairment on 5 items relating to Obsessions from 0 (none) to 4 (extreme) and 5 item relating to Compulsions from 0 (none) to 4 (extreme). These scores are totaled for a range of 0 (least impaired) to 40 (most impaired).|weekly|2 participants were not included in final analysis - 1 terminated at 1 week due to non-compliance with taking study medication. 1 found ineligible prior to beginning treatment.||Units on a scale||Standard Deviation|Mean
755204|NCT00592904|Secondary|Mean Change From Baseline in Short Form 36 Item (SF-36) Health Survey: Physical and Mental Component Scores From Baseline to Week 48/EOT|Mean change from baseline in SF-36 Item Health Survey Scores at study endpoint. Each component on the SF-36 Item Health Survey is scored from 0-100 with higher scores reflecting better subject status.|Baseline and Week 48|ITT Population||Scores on a Scale||Standard Deviation|Mean
755205|NCT00592904|Secondary|Analysis of Patient Global Impression of Change (PGIC) at Week 48/End of Treatment (EOT)|The PGIC asked subjects to evaluate the change in their overall status compared with the start of open-label treatment on a scale ranging from 1 (very much improved) to 7 (very much worse). [Please note high withdrawl rate during study].|Baseline and Week 48|Subset of ITT population used, including subjects that completed PGIC at Week 15 visit, and using BOCF (baseline observation carried forward) subjects that terminated prior to Week 15 received a 'No Change' if due to AE or Lack of Therapeutic Efficacy, subjects who discontinued due to other reasons used PGIC scores from Early Termination visit.||Participants|||Number
755206|NCT00592904|Primary|Mean Change From Baseline in SF-MPQ Current Pain Intensity (CPI): From Baseline to Week 48|Mean change from baseline in SF-MPQ (CPI) at study endpoint. Affective score ranges from 0-5. Higher scores indicate more severe pain (0=no pain, 1=mild, 2=discomforting, 3=distressing, 4=horrible, 5=excrutiating).|Baseline and Week 48|ITT Population||Scores on a Scale||Standard Deviation|Mean
755207|NCT00592904|Primary|Mean Change From Baseline in SF-MPQ Visual Analog Scale (VAS): From Baseline to Week 48.|SF-MPQ VAS consists of a line 0 to 100 millimeters (mm) in length; range is 0 (no pain) to 100 mm (worst possible pain). Subjects placed a mark indicating the intensity of their pain. Distance from left-hand end of line was measured and entered on Case Report Form (CRF) as score in mm. Higher score indicates greater level of pain.|Baseline and Week 48|ITT Population||Scores on a Scale||Standard Deviation|Mean
755208|NCT00592904|Primary|Mean Change From Baseline in Short Form-McGill Pain Questionnaire (SF-MPQ): Sensory and Affective Scores, From Baseline to Week 48.|Mean change from baseline to open-label study endpoint and other study visits in SF-MPQ scores sensory and affective). SF-MPQ was completed to assess intensity of pain over the past 48 days for all 15 descriptors: throbbing, shooting, stabbing, sharp, cramping, gnawing, hot-burning, aching, heavy, tender, splitting,tiring-exhausting, sickening, fear-causing, punishing-cruel. Each descriptor was scored by participant on a 4-point intensity scale (0=none to 3=severe) and totaled in each subclass (sensory range 0-45); higher scores indicated higher intensity of pain.|Baseline and Week 48|Intent-to-Treat (ITT) Population: All enrolled subjects (starting at Visit 1) who took at least 1 dose of study drug and had at least 1 efficacy assessment in this trial comprised the ITT Population. All efficacy analyses were performed on the ITT Population. One subject had a protocol violation after consenting and was withdrawn from treatment.||Scores on a Scale||Standard Deviation|Mean
755209|NCT00592943|Primary|Armodafinil Extracellular Dopamine in Caudate at 2.5 Hours (Without Outlier)|Each subject received each dose level (one dose per day of 100 or 250 mg) of armodafinil, followed by PET scans using [11C]raclopride, to determine the change in extracellular dopamine at 2.5 hours postdose.|Extracellular DAT was measured using the PET scan at 2.5 hours after oral administration of 100mg or 250 mg Armodafinil on three different study visits|||μg/mL||Standard Deviation|Mean
755210|NCT00592943|Primary|Armodafinil Extracellular Dopamine in Caudate at 2.5 Hours (With Outlier)|Each subject received each dose level (one dose per day of 100 or 250 mg) of armodafinil, followed by PET scans using [11C]raclopride, to determine the change in extracellular dopamine at 2.5 hours postdose.|Extracellular DAT was measured using the PET scan at 2.5 hours after oral administration of 100mg or 250 mg Armodafinil on three different study visits|||μg/mL||Standard Deviation|Mean
755211|NCT00592943|Primary|Armodafinil DAT Occupancy in Caudate|Subjects received each dose level (100 and 250 mg) of armodafinil, followed by PET scans, in an open-label protocol. Repeat PET scans, using [1 1 C]altropane, determined DAT occupancy at 1 hour and 2.5 hours postdose (compared with baseline).|DAT occupancy was measured using the PET scan at 1 hour and 2.5 hours after oral administration of 100mg or 250 mg Armodafinil|||μg/mL||Standard Deviation|Mean
755230|NCT00593346|Secondary|Quality of Life Completion|-QOL was assessed using the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and EORTC breast cancer module QLQ-BR23 questionnaires. QLQ-C30 is composed of 30 questions. QLQ-BR23 consists of 23 questions.|2 years|||percentage of participants|||Number
755213|NCT00593112|Primary|H MRS Scan Results - Glutamine (Gln)/Ino|"Comparison of treated ADHD participants (6 weeks on Concerta) and Healthy Control Subjects (HCS)
This measure is a ratio of Glutamine (amino acid precursor to Glu) to myo-inositol (cyclic sugar alcohol) containing compounds in the anterior cingulate."|after 6 weeks Concerta treatment|Seven subjects who completed the protocol were not included due to a lack of baseline comparison.||MRS Ratios||Standard Deviation|Mean
755214|NCT00593112|Primary|Proton Magnetic Resonance Spectroscopy (H MRS) Scan Results - Glutamate(Glu)/Myo-inositol-containing Compounds (Ino)|"Comparison of treated ADHD participants (6 weeks on Concerta) and Healthy Control Subjects (HCS)
This measure is a ratio of Glutamate (excitatory neurotransmitter) to myo-inositol (cyclic sugar alcohol) containing compounds in the anterior cingulate."|after 6 weeks Concerta treatment|Seven subjects who completed the protocol were not included due to a lack of baseline comparison.||MRS Ratio||Standard Deviation|Mean
755215|NCT00593320|Primary|Quality of Life as Measured by the FACT-CNS Questionnaire|"The Functional Assessment of Cancer Therapy - Central Nervous System (FACT-CNS). The FACT-CNS consists of Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, Functional Well-Being, and Additional Concerns.
Participants can choose 0 (Not At All) up to 4 (Very Much) for each question."|6 months after completion of treatment|One patient experienced disease progression and was unable to continue to complete the required questionnaires. The second patient was removed from study due to non-compliance and did not complete the required questionnaires.|||||
755216|NCT00593320|Primary|Musculoskeletal Function as Measured by the Oswestry Disability Index|The Oswestry Disability Index (ODI) has 10 sections (pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling), each of which contains 6 questions detailing the effect of pain on the ability of the patient to perform activities related to the topic of each section.|6 months after completion of treatment|One patient experienced disease progression and was unable to continue to complete the required questionnaires. The second patient was removed from study due to non-compliance and did not complete the required questionnaires.|||||
755217|NCT00593320|Secondary|Local Control Rate|Local control is lack of local failure. Local failure refers to the primary treated tumor after protocol therapy and corresponds to meeting both the following two criteria: 1) Increase in tumor dimension of 20% increase in the longest diameter of the target lesion tasking as reference the smallest longest diameter since the treatment started (referred to as local enlargement). 2) The measurable tumor with criteria meeting local enlargement should be avid on PET imaging (or bone scan) with uptake of a similar intensity as the pretreatment staging PET (or bone scan), or the measurable tumor should be biopsied confirming viable carcinoma.|6 months after end of treatment|The first patient progressed while on treatment and the second patient was removed from study due to non-compliance.|||||
755218|NCT00593320|Primary|Pain Control Rate as Measured by the The Brief Pain Inventory|The Brief Pain Inventory (BPI) is a 17 item patient self-rating scale assessing demographic data, use of medications, as well as sensory, and reactive components of pain.|6 months after completion of treatment|One patient experienced disease progression and was unable to continue to complete the required questionnaires. The second patient was removed from study due to non-compliance and did not complete the required questionnaires.|||||
755219|NCT00593333|Primary|Healed Femur Fracture|Time to clinically healed fracture as measured by weeks.|baseline to healed fracture (weeks)|||Weeks||Full Range|Mean
755220|NCT00593346|Secondary|Frequency of Grade 3-4 Toxicities|RTOG acute and late toxicity grading system and via a visual analog scale for pain assessment.|Up to 1 year from completion of therapy|||participants|||Number
755221|NCT00593346|Secondary|Occurrence of Mastectomy After Completion of Initial Breast-conserving Treatment||5 years after treatment completion|||participants|||Number
755222|NCT00593346|Secondary|Presence or Absence of Complications|As defined by number of participants who experienced breast infection and symptomatic fat necrosis.|5 years after treatment completion|||participants|||Number
755223|NCT00593346|Primary|Local Control Using Disease-free Survival Rates||5 years after treatment completion|||percentage of participants|||Number
755224|NCT00593346|Primary|Local Control Using Disease-free Survival Rates||2 years after treatment completion|||percentage of participants|||Number
755225|NCT00593346|Primary|Local Control as Measured by Ipsilateral Breast Tumor Recurrence Rates||5 years after treatment completion|||percentage of participants|||Number
755226|NCT00593346|Secondary|Cosmesis Outcome as Measured by Percentage of Breast Retraction Assessment (pBRA)|-Cosmetic outcome was evaluated quantitatively by percentage of breast retraction assessment (pBRA)|Pre-treatment and 3 years|82 participants had cosmetic outcome data through 3 years of follow-up.||percentage of breast retraction||95% Confidence Interval|Mean
755227|NCT00593346|Secondary|Impressions of the Cause of Cosmesis Changes Over Time - Patient Reported|"-Patients filled out a form Patient Evaluation of the Treated Breast. On this form the patients were asked to compare the memory of what their breast looked like after surgery but before radiation and to compare that memory to the appearance of the breast after radiation. The patients were then asked if their breast changes were due to:
caused mostly by radiation
caused by both the radiation and surgery, but mostly by the radiation
caused by both the radiation and surgery, but mostly by the surgery
caused mostly by the surgery
can't judge which treatment caused the change
there are no changes"|3 years|82 participants had cosmetic outcome data through 3 years of follow-up.||percentage of participants|||Number
755228|NCT00593346|Secondary|Excellent-good Cosmetic Outcomes - Physician Reported|"Both the participants and the treating radiation oncologist qualitatively rated cosmesis as excellent, good, fair, or poor over time and ascribed a cause for changes in cosmesis. Cosmetic outcome was evaluated quantitatively by percentage of breast retraction assessment (pBRA).
The global cosmetic result were scored on a 4-point scale where 0=excellent result (no difference), 1=good (small difference), 2=fair result (moderate difference) and 3=poor result (large difference)."|3 years after completion of therapy|82 participants had cosmetic outcome data through 3 years of follow-up.||percentage of participants|||Number
755229|NCT00593346|Secondary|Excellent-good Cosmetic Outcomes - Patient Reported|"Both the participants and the treating radiation oncologist qualitatively rated cosmesis as excellent, good, fair, or poor over time and ascribed a cause for changes in cosmesis.
The global cosmetic result were scored on a 4-point scare where 0=excellent result (no difference), 1=good (small difference), 2=fair result (moderate difference) and 3=poor result (large difference)."|3 years after completion of therapy|82 participants had cosmetic outcome data through 3 years of follow-up.||percentage of participants|||Number
755248|NCT00593450|Primary|Change From Baseline in Visual-acuity Score (Continuous)|"Visual acuity testing was performed with the Electronic Visual Tester (EVA) following the ETDRS protocol. VA score is measured as number of letters read correctly. The VA score change is the difference of the VA score at 1 Year and the VA score at baseline.
In this study, the outcome VA score change is ranged from -71 to 52, with the higher VA score change the better visual acuity improvement."|Baseline and 1 Year|All patients who had VA measured at week 52 were included in the analysis. All analyses were performed on the basis of the intention-to-treat principle. The Data and Safety Monitoring Committee recommended that data for all 23 patients at one center be excluded because of serious protocol noncompliance.||No. of Letters||Standard Deviation|Mean
755249|NCT00593450|Secondary|Change From Baseline Visual-acuity Score (Frequency)||Baseline and 1 Year|||Participants|||Number
755250|NCT00593606|Secondary|Patient Treatment Preference Scale Question 7|What aspects do you like the least about the patch? Check all that apply.|28 days|Full Analysis Set||participants|||Number
755251|NCT00593606|Secondary|Patient Treatment Preference Scale Question 6|What aspects do you like the most about the patch?|28 days|Full Analysis Set||participants|||Number
755252|NCT00593606|Secondary|Patient Treatment Preference Scale Question 5|I would prefer applying one 40cm**2 patch over applying two 20cm**2 patches for treatment of my Parkinson’s disease.|28 days|Full Analysis Set||participants|||Number
755253|NCT00593606|Secondary|Patient Treatment Preference Scale Question 4|I would prefer using a patch over taking a pill or capsule for treatment of my Parkinson’s disease.|28 days|Full Analysis Set||participants|||Number
755254|NCT00593606|Secondary|Patient Treatment Preference Scale Question 3|In comparing the patch and previous oral treatments for Parkinson’s disease, how satisfied have you been with oral medication / patch?|28 days|Full Analysis Set||participants|||Number
755255|NCT00593606|Secondary|Patient Treatment Preference Scale Question 2|Why did you decide to enter this study?|28 days|Full Analysis Set||participants|||Number
755256|NCT00593606|Secondary|Patient Treatment Preference Scale Question 1|Have you used pharmaceutical treatments for your Parkinson’s disease before the study?|28 days|Full Analysis Set||participants|||Number
755257|NCT00593606|Secondary|Change in Short-form Parkinson's Disease Questionnaire (PDQ-8) Single Index Score From Baseline to End of Treatment|"The PDQ-8 is a self-administered 8-item questionnaire that assesses issues associated with Parkinson's disease.
Range: 0 (good health) to 100 (poor health) Change = 28 day value minus baseline value."|Baseline, 28 days|Full Analysis Set, only patients with non-missing values were analyzed||score on scale||Standard Deviation|Mean
755258|NCT00593606|Secondary|Patient Global Impression (PGI) Item 3|"The PGI is a set of ratings made by the patient in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time.
Item 3 measures 'Side Effects'. Range: 1 (I have no side effects) to 4 (They outweigh the therapeutic effect of the trial medication)"|28 days|Full Analysis Set||participants|||Number
755259|NCT00593606|Secondary|Patient Global Impression (PGI) Item 2|"The PGI is a set of ratings made by the patient in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time.
Item 2 measures 'Therapeutic Effect'. Range: 1 (Marked – Vast improvement. Complete or nearly complete remission of all symptoms) to 4 (Unchanged or worse)"|28 days|Full Analysis Set||participants|||Number
755260|NCT00593606|Secondary|Patient Global Impression (PGI) Item 1 Score|"The PGI is a set of ratings made by the patient in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time.
Item 1 measures 'Global Improvement'. Range: 1 (Very much improved) to 7 (Very much worse)"|28 days|Full Analysis Set, only patients with non-missing values were analyzed||score on scale||Standard Deviation|Mean
755261|NCT00593606|Secondary|Clinical Global Impression (CGI) Item 3.2|"The CGI is a set of ratings made by a clinician in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time.
Item 3.2 measures 'Therapeutic Side Effects'. Range: 1 (None) to 4 (Outweigh the therapeutic effect)"|28 days|Full Analysis Set||participants|||Number
755262|NCT00593606|Secondary|Clinical Global Impression (CGI) Item 3.1|"The CGI is a set of ratings made by a clinician in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time.
Item 3.1 measures 'Therapeutic Effect'. Range: 1 (Marked – Vast improvement. Complete or nearly complete remission of all symptoms.) to 4 (Unchanged or worse)"|28 days|Full Analysis Set||participants|||Number
755263|NCT00593606|Secondary|Clinical Global Impression (CGI) Item 2 Score|"The CGI is a set of ratings made by a clinician in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time.
Item 2 measures 'Global Improvement'. Range 1 (Very much improved) to 7 (Very much worse)"|28 days|Full Analysis Set, only patients with non-missing values were analyzed||score on scale||Standard Deviation|Mean
755264|NCT00593606|Secondary|Change in Clinical Global Impression (CGI) Item 1 Score From Baseline to End of Treatment|"The CGI is a set of ratings made by a clinician in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time.
Item 1 measures 'Severity of Parkinson’s Disease'. Range: 1 (Normal, not ill at all) to 7 (Among the most extremely ill patients) Change = 28 day value minus baseline value."|Baseline, 28 days|Full Analysis Set||score on scale||Standard Deviation|Mean
755265|NCT00593606|Secondary|Change in Parkinson’s Disease Non-Motor Symptom Assessment Scale (PDNMS) Total Sum Score From Baseline to End of Treatment|The PDNMS is a rating by the clinician to assess the severity and frequency of non-motor symptoms in Parkinson’s disease patients Range: 0 (Best score possible) to 384 (Worst score possible) Change = 28 day value minus baseline value.|Baseline, 28 days|Full Analysis Set, only patients with non-missing values were analyzed||score on scale||Standard Deviation|Mean
755266|NCT00593606|Secondary|Change in Epworth Sleepiness Scale (ESS) Sum Score From Baseline to End of Treatment|The ESS is a self-administered questionnaire in which the subject rates the probability of his/her dozing during 8 situations that are differently conductive to sleep Range: 0 (Best score possible) to 24 (Worst score possible) Change = 28 day value minus baseline value.|Baseline, 28 days|Full Analysis Set, only patients with non-missing values were analyzed||score on scale||Standard Deviation|Mean
755297|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for ‘Hematological/Lymphatic Nodes’||28 days|Safety Set, only patients with non-missing values were analyzed||participants|||Number
755267|NCT00593606|Secondary|Change in Parkinson’s Disease Sleep Scale (PDSS) Sum Score From Baseline to End of Treatment|"The PDSS is a scale to assess sleep and nocturnal disability in Parkinson’s disease.
Range: 0 (Best score possible) to 60 (Worst score possible) Change = 28 day value minus baseline value."|Baseline, 28 days|Full Analysis Set, only patients with non-missing values were analyzed||score on scale||Standard Deviation|Mean
755268|NCT00593606|Secondary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score From Baseline to End of Treatment|The UPDRS is a scale for the assessment of function in Parkinson’s disease UPDRS Part IV measures 'Complications of Therapy'. Range: 0 (Best score possible) to 23 (Worst score possible) Change = 28 day value minus baseline value.|Baseline, 28 days|Full Analysis Set, only patients with non-missing values were analyzed||score on scale||Standard Deviation|Mean
755269|NCT00593606|Secondary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score From Baseline to End of Treatment|The UPDRS is a scale for the assessment of function in Parkinson’s disease UPDRS Part III measures 'Motor Examination'. Range: 0 (Best score possible) to 56 (Worst score possible) Change = 28 day value minus baseline value.|Baseline, 28 days|Full Analysis Set, only patients with non-missing values were analyzed||score on scale||Standard Deviation|Mean
755270|NCT00593606|Secondary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score From Baseline to End of Treatment|The UPDRS is a scale for the assessment of function in Parkinson’s disease UPDRS Part II measures 'Activities in Daily Living'. Range: 0 (Best score possible) to 52 (Worst score possible) Change = 28 day value minus baseline value.|Baseline, 28 days|Full Analysis Set, only patients with non-missing values were analyzed||score on scale||Standard Deviation|Mean
755271|NCT00593606|Secondary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score From Baseline to End of Treatment|The UPDRS is a scale for the assessment of function in Parkinson’s disease UPDRS Part I measures 'Mentation, Behavior and Mood'. Range: 0 (Best score possible) to 16 (Worst score possible) Change = 28 day value minus baseline value.|Baseline, 28 days|Full Analysis Set, only patients with non-missing values were analyzed||score on scale||Standard Deviation|Mean
755272|NCT00593606|Primary|Dose Reduction Due to Adverse Events (AEs) With Onset During the 5 Half-life Overlap Period||Baseline, 56 days|Safety Set||participants|||Number
755273|NCT00593606|Primary|Dose Reduction During the 5 Half-life Overlap Period Due to Adverse Events (AEs)||Baseline, 2 days|Safety Set||participants|||Number
755274|NCT00593606|Primary|Drop-out Due to Adverse Events (AEs) With Onset During the 5 Half-life Overlap Period||Baseline, 56 days|Safety Set||participants|||Number
755275|NCT00593606|Primary|Drop-out During the 5 Half-life Overlap Period Due to Adverse Events (AEs)||Baseline, 2 days|Safety Set||participants|||Number
755276|NCT00593606|Primary|Completion of Trial on the Original Treatment Assignment From Baseline to End of Treatment||Baseline, 28 days|Safety Set||participants|||Number
755277|NCT00593606|Primary|Completion of Trial From Baseline to End of Treatment||Baseline, 28 days|Safety Set||participants|||Number
755278|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for ‘Other’||28 days|Safety Set, only patients with non-missing values were analyzed||participants|||Number
755279|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for ‘Sensory Perception’||28 days|Safety Set, only patients with non-missing values were analyzed||participants|||Number
755280|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for ‘Involuntary Movements’||28 days|Safety Set, only patients with non-missing values were analyzed||participants|||Number
755281|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for ‘Coordination/Balance’||28 days|Safety Set, only patients with non-missing values were analyzed||participants|||Number
755282|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for ‘Gait’||28 days|Safety Set, only patients with non-missing values were analyzed||participants|||Number
755283|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for ‘Plantar Reflex’||28 days|Safety Set, only patients with non-missing values were analyzed||participants|||Number
755284|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for ‘Cranial Nerve Function’||28 days|Safety Set, only patients with non-missing values were analyzed||participants|||Number
755285|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for ‘Muscle Strength’||28 days|Safety Set, only patients with non-missing values were analyzed||participants|||Number
755286|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for ‘Deep Tendon Reflexes’||28 days|Safety Set, only patients with non-missing values were analyzed||participants|||Number
755287|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for ‘Mental Status’||28 days|Safety Set, only patients with non-missing values were analyzed||participants|||Number
755288|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for ‘Other’||28 days|Safety Set, only patients with non-missing values were analyzed||participants|||Number
755289|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for ‘Metabolic/Endocrine’||28 days|Safety Set, only patients with non-missing values were analyzed||participants|||Number
755290|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for ‘Renal/Genitourological’||28 days|Safety Set, only patients with non-missing values were analyzed||participants|||Number
755291|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for ‘Hepato-/Gastrointestinal’||28 days|Safety Set, only patients with non-missing values were analyzed||participants|||Number
755292|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for ‘Musculoskeletal’||28 days|Safety Set, only patients with non-missing values were analyzed||participants|||Number
755293|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for ‘Pulmonary’||28 days|Safety Set, only patients with non-missing values were analyzed||participants|||Number
755294|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for ‘Peripheral Vascular’||28 days|Safety Set, only patients with non-missing values were analyzed||participants|||Number
755326|NCT00593606|Primary|Change in QT Interval Corrected for Heart Rate According to Bazett's Formula (QTcB)|"The QT interval is the period that extends from the beginning of ventricular depolarization until the end of ventricular repolarization.
Change = 28 day value minus baseline value."|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||msec||Standard Deviation|Mean
755327|NCT00593606|Primary|Change in QT Interval|"The QT interval is the period that extends from the beginning of ventricular depolarization until the end of ventricular repolarization.
Change = 28 day value minus baseline value."|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||msec||Standard Deviation|Mean
755328|NCT00593606|Primary|Change in QRS Duration|"The QRS duration represents the time it takes for ventricular depolarization to occur.
Change = 28 day value minus baseline value."|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||msec||Standard Deviation|Mean
755329|NCT00593606|Primary|Change in PR Interval|"The PR interval is defined as the period that extends from the onset of atrial depolarization (beginning of the P wave) until the onset of ventricular depolarization (beginning of the QRS complex).
Change = 28 day value minus baseline value."|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||msec||Standard Deviation|Mean
755330|NCT00593606|Primary|Change in Heart Rate|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||beats per minute||Standard Deviation|Mean
755331|NCT00593606|Primary|Change in Diastolic Blood Pressure (Standing, After 3 Minutes)|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||mmHg||Standard Deviation|Mean
755332|NCT00593606|Primary|Change in Systolic Blood Pressure (Standing, After 3 Minutes)|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||mmHg||Standard Deviation|Mean
755333|NCT00593606|Primary|Change in Pulse Rate (Standing, After 3 Minutes)|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||beats per minute||Standard Deviation|Mean
755334|NCT00593606|Primary|Change in Diastolic Blood Pressure (Standing, After 1 Minute)|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||mmHg||Standard Deviation|Mean
755335|NCT00593606|Primary|Change in Systolic Blood Pressure (Standing, After 1 Minute)|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||mmHg||Standard Deviation|Mean
755336|NCT00593606|Primary|Change in Pulse Rate (Standing, After 1 Minute)|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||beats per minute||Standard Deviation|Mean
755337|NCT00593606|Primary|Change in Diastolic Blood Pressure (Supine, After 5 Minutes)|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||mmHg||Standard Deviation|Mean
755338|NCT00593606|Primary|Change in Systolic Blood Pressure (Supine, After 5 Minutes)|Change = 28 day value minus baseline value.|Baseline, 28 Days|Safety Set, only patients with non-missing values were analyzed||mmHg||Standard Deviation|Mean
755339|NCT00593606|Primary|Change in Pulse Rate (Supine, After 5 Minutes)|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||beats per minute||Standard Deviation|Mean
755340|NCT00593606|Primary|Change in Diastolic Blood Pressure (Supine, After 1 Minute)|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||mmHg||Standard Deviation|Mean
755341|NCT00593606|Primary|Change in Systolic Blood Pressure (Supine, After 1 Minute)|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||mmHg||Standard Deviation|Mean
755342|NCT00593606|Primary|Change in Pulse Rate (Supine, After 1 Minute)|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||beats per minute||Standard Deviation|Mean
755343|NCT00593645|Secondary|Median Time to Progression|Time to progression is defined as the length of time from the start of treatment until the disease starts to get worse or spread to other parts of the body.|5 years from time of restaging|Of the four surviving patients, three relapsed. One patient remained in remission on day +120.||days||Full Range|Median
755344|NCT00593645|Secondary|Use Conventional STR-PCR Method for Monitoring Engraftment|Includes assessment of mixed chimerism in the whole blood, myeloid cells, T cells, and B cells.|Up to 1 year after transplant|This outcome was not analyzed specifically as the conventional STR-PCR method was used for monitoring engraftment.|||||
755345|NCT00593645|Secondary|Rate of Chronic Graft-versus-host Disease (GVHD)||100 days-1 year after transplant|None of the participants had chronic graft-versus-host disease (GVHD). 3 participants expired prior to day 100.||percentage of participants|||Number
755346|NCT00593645|Secondary|Rate of Acute Graft-versus-host Disease (GVHD)|Acute GVHD occurs within 100 days of transplant.|Up to 100 days after transplant|||percentage of participants|||Number
755347|NCT00593645|Secondary|Disease-free Survival|Disease-free survival is defined as the length of time after treatment ends that the participant survives without any signs or symptoms of that cancer.|5 years from time of restaging|None of the patients analyzed survived without any signs or symptoms of that cancer.||participants|||Number
755348|NCT00593645|Secondary|Overall Survival||5 years from time of restaging|||days||Full Range|Median
755349|NCT00593645|Secondary|Engraftment as Measured by Percent Donor Chimerism||Day +80-+90|3 participants were not analyzed as they were deceased.||participants|||Number
755350|NCT00593645|Secondary|Engraftment as Measured by Percent Donor Chimerism||Day +40-+60|3 participants were not analyzed because they were expired.||participants|||Number
755351|NCT00593645|Secondary|Engraftment as Measured by Percent Donor Chimerism||Day +30|2 participants were not analyzed because they expired prior to Day +30.||participants|||Number
755352|NCT00593645|Secondary|Disease Specific Response Rates|Disease-specific partial response and complete response.|One, three, six and twelve months.|"This outcome was not analyzed due to terminating the study after 7 participants were enrolled.
We felt that the engraftment as measured by percent donor chimerism provided better response details than the limited data that was collected for the disease specific partial and complete response rates."|||||
755353|NCT00593645|Primary|Six-month Treatment Related Mortality||6 months|"This outcome was not analyzed.
Enrollment to the trial was halted after three of the first seven patients expired. This fulfilled the predefined stopping rule as it was unlikely that we would achieve our primary end point of a 6 month treatment-related mortality of 10%."|||||
755354|NCT00593684|Secondary|Infection Rate|Infection was defined as recovery of a bacterial pathogen or fungus from any single blood culture. Infection rate was defined as Infections/1000 line days.|infection per 1,000 Line Days|||Infection per 1,000 line days|||Number
755355|NCT00593684|Primary|Serum Silver Concentrate at 28 Days|Serum silver concentrations were obtained from both groups on study days 1, 7, and 28. Study day 1 was defined as the 24 hour period in which participants enrolled in the study. Here we examine results at 28 days from enrollment. Silver samples were analyzed using a dual inductively coupled plasma -mass spectrometry methodology. Accepted reference values for non-exposure silver concentrations are defined as <15 ng ml -1 with standard Mayo Clinic reference technique.|28 Days from enrollment|two subjects died in the treatment group; one subject died in the control group||ng ml -1||Standard Deviation|Mean
755356|NCT00593684|Primary|Serum Silver Concentration at 7 Days|Serum silver concentrations were obtained from both groups on study days 1, 7, and 28. Study day 1 was defined as the 24 hour period in which participants enrolled in the study. Here we examine the results at 7 days from enrollment. Silver samples were analyzed using a dual inductively coupled plasma -mass spectrometry methodology. Accepted reference values for non-exposure silver concentrations are defined as <15 ng ml -1 with standard Mayo Clinic reference technique.|7 Days from enrollment|One subject in each group died||ng ml -1||Standard Deviation|Mean
755357|NCT00593684|Primary|Serum Silver Concentration at 1 Day|Serum silver concentrations were obtained from both groups on study days 1, 7, and 28. Study day 1 was defined as the 24 hour period in which participants enrolled in the study. Here we are examining the results of first day, or 24 hours from enrollment. Silver samples were analyzed using a dual inductively coupled plasma -mass spectrometry methodology. Accepted reference values for non-exposure silver concentrations are defined as <15 ng ml -1 with standard Mayo Clinic reference technique.|1 Day (first 24 hours from enrollment)|Study design included intent-to-treat for data collection and intention to stop if signs of toxicities or adverse effects were noted.||ng ml -1||Standard Deviation|Mean
755358|NCT00593736|Secondary|Average Cmax (Maximum Observed Plasma Concentration) Calculated as the Average of Three Highest Cmax Observations Within the Sampling Period.|Average Cmax calculated as the average of three highest Cmax observations within the sampling period.|Day 15|The melatonin set included all subjects who had saliva samples collected under dim light conditions for melatonin measurement.||μg/dL||Standard Error|Least Squares Mean
755359|NCT00593736|Secondary|The Area Under the Concentration-time Curve of Melatonin From 0 to 24 Hours|Area under the concentration-time curve is a measure of total drug exposure.|Day 15|The melatonin set included all subjects who had saliva samples collected under dim light conditions for melatonin measurement.||μg/dL/hour||Standard Error|Least Squares Mean
755360|NCT00593736|Secondary|The Total Duration of Secretion of Melatonin|The total duration of time from Dim Light Melatonin Secretion Onset to Dim Light Melatonin Secretion Offset.|Day 15|The melatonin set included all subjects who had saliva samples collected under dim light conditions for melatonin measurement.||minutes||Standard Error|Least Squares Mean
755361|NCT00593736|Secondary|The Time of Dim Light Melatonin Secretion Offset|Dim Light Melatonin Secretion Offset is defined as the first time of the morning (on a 24-hour clock) when the melatonin drops to below 3 pg/mL with a negative slope. Units are hours and minutes on a 24-hour clock, expressed in decimal time.|Day 15|The melatonin set included all subjects who had saliva samples collected under dim light conditions for melatonin measurement.||hours on a 24-hour clock||Standard Error|Least Squares Mean
755362|NCT00593736|Secondary|The Time of Dim Light Melatonin Secretion Onset|Linear Dim Light Melatonin Secretion Onset is defined as the first time of the evening (on a 24-hour clock) when the melatonin level rises above 3.0 pg/ml with a positive slope. Units are hours and minutes on a 24-hour clock, expressed in decimal time.|Day 15|The melatonin set included all subjects who had saliva samples collected under dim light conditions for melatonin measurement.||hours on a 24-hour clock||Standard Error|Least Squares Mean
755363|NCT00593736|Secondary|Visual Analogue Scale for Feelings|Subjects marked visual scales (in millimeters) that represented ranges of emotions (eg, calm to anxious; normal to bloated; energetic to fatigued). Individual subject composite scores were calculated, and the average of 2 tests were analyzed. Worst Value:0 mm.. Best Value:100 mm.. The farther to the left a subject marks, the better their mood; farther to the right, the more distressed the mood. Higher numbers indicate a more distressed mood.|Day 15|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||Units on a scale||Standard Error|Least Squares Mean
755364|NCT00593736|Secondary|Visual Analogue Scale for Mood|Subjects marked visual scales (in millimeters) that represented ranges of emotions (eg, calm to anxious; normal to bloated; energetic to fatigued). Individual subject composite scores were calculated, and the average of 2 tests were analyzed. Worst Value: 0 mm. Best Value: 100 mm. The farther to the left a subject marks, the better their mood; farther to the right, the more distressed the mood. Higher numbers indicate a more distressed mood.|Day 15|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||Units on a scale||Standard Error|Least Squares Mean
755365|NCT00593736|Secondary|Next Morning Residual Effects Assessments of Psychomotor and Cognitive Function Via Memory Recall Test--Delayed|After 16 words were read to a subject, a subject waited 1 minute and then was given 2 minutes to write down as many words as he/she remembered. The correct number of words written was scored, and the average of 2 mornings’ tests was calculated.|Day 15|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||score||Standard Error|Least Squares Mean
755366|NCT00593736|Secondary|Next Morning Residual Effects Assessments of Psychomotor and Cognitive Function Via Memory Recall Test--Immediate|After 16 words were read to a subject, a subject was given 2 minutes to write down as many words as he/she remembered. The correct number of words written was scored, and the average of 2 mornings’ tests was calculated.|Day 15|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||score||Standard Error|Least Squares Mean
755367|NCT00593736|Secondary|Next Morning Residual Effects Assessments of Psychomotor and Cognitive Function Via Digit Symbol Substitution Test|The number of correct digit-for-number substitutions on a Digit Symbol Substitution Test in the 90-second period was recorded to assess psychomotor and cognitive function. The score was the average of 2 mornings' tests. Worst Value: 0. Best Value: No Limit.|Day 15|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||Scores on a scale||Standard Error|Least Squares Mean
755368|NCT00593736|Secondary|Subjective Level of Alertness Measured by a Post-sleep Questionnaire (Nights 13-14)|Subjective level of alertness was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, “How would you describe your level of alertness this morning?” Scores were based on the following scale: Extremely Poor=7; Very Poor=6; Poor=5; Fair=4; Good=3; Very Good=2; Excellent=1.|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||scores on a scale||Standard Error|Least Squares Mean
755369|NCT00593736|Secondary|Subjective Level of Alertness Measured by a Post-sleep Questionnaire (Nights 6-7)|Subjective level of alertness was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, “How would you describe your level of alertness this morning?” Scores were based on the following scale: Extremely Poor=7; Very Poor=6; Poor=5; Fair=4; Good=3; Very Good=2; Excellent=1.|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||scores on a scale||Standard Error|Least Squares Mean
755370|NCT00593736|Secondary|Subjective Ability to Concentrate in the Morning Measured by a Post-sleep Questionnaire (Nights 13-14)|Subjective ability to concentrate was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, “How would you describe your ability to concentrate this morning?” Scores were based on the following scale: Extremely Poor=7; Very Poor=6; Poor=5; Fair=4; Good=3; Very Good=2; Excellent=1.|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||scores on a scale||Standard Error|Least Squares Mean
755371|NCT00593736|Secondary|Subjective Ability to Concentrate in the Morning Measured by a Post-sleep Questionnaire (Nights 6-7)|Subjective ability to concentrate was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, “How would you describe your ability to concentrate this morning?” Scores were based on the following scale: Extremely Poor=7; Very Poor=6; Poor=5; Fair=4; Good=3; Very Good=2; Excellent=1.|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||scores on a scale||Standard Error|Least Squares Mean
755372|NCT00593736|Secondary|Subjective Getting up in the Morning Measured by a Post-sleep Questionnaire (Nights 13-14)|The score was an average of 2 nights responses. If subjects had a work or school day, the answer to, “How easy was it for you to wake or get up in the morning when on a school or working night?” was based on the following scale: Extremely Difficult =7; Very Difficult =6; Difficult =5; Neither =4; Easy =3; Very Easy =2; Extremely Easy =1.|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||scores on a scale||Standard Error|Least Squares Mean
755373|NCT00593736|Secondary|Subjective Getting up in the Morning Measured by a Post-sleep Questionnaire (Nights 6-7)|The score was an average of 2 nights responses. If subjects had a work or school day, the answer to, “How easy was it for you to wake or get up in the morning when on a school or working night?” was based on the following scale: Extremely Difficult =7; Very Difficult =6; Difficult =5; Neither =4; Easy =3; Very Easy =2; Extremely Easy =1.|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||scores on a scale||Standard Error|Least Squares Mean
755374|NCT00593736|Secondary|Subjective Sleep Time Measured by a Post-sleep Questionnaire (Nights 13-14)|Subjective sleep time was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, “What time did you try to go to sleep last night?” Units are hours and minutes on a 24-hour clock, expressed in decimal time.|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||hours on a 24-hour clock||Standard Error|Least Squares Mean
755375|NCT00593736|Secondary|Subjective Sleep Time Measured by a Post-sleep Questionnaire (Nights 6-7)|Subjective sleep time was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, “What time did you try to go to sleep last night?” Units are hours and minutes on a 24-hour clock, expressed in decimal time.|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||hours on a 24-hour clock||Standard Error|Least Squares Mean
755376|NCT00593736|Secondary|Subjective Sleep Quality Measured by a Post-sleep Questionnaire (Nights 13-14)|Subjective sleep quality was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, “How would you describe the quality of your sleep last night?” Scores were based on the following scale: Extremely Poor=7; Very Poor=6; Poor=5; Fair=4; Good=3; Very Good=2; Excellent=1.|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||scores on a scale||Standard Error|Least Squares Mean
755377|NCT00593736|Secondary|Subjective Sleep Quality Measured by a Post-sleep Questionnaire (Nights 6-7)|Subjective sleep quality was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, “How would you describe the quality of your sleep last night?” Scores were based on the following scale: Extremely Poor=7; Very Poor=6; Poor=5; Fair=4; Good=3; Very Good=2; Excellent=1.|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||scores on a scale||Standard Error|Least Squares Mean
755378|NCT00593736|Secondary|Subjective Number of Awakenings Measured by a Post-sleep Questionnaire (Nights 13-14)|Subjective number of awakenings was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, “Did you wake up during the night? If “yes”, how many times do you think you woke up?”|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||number of awakenings||Standard Error|Least Squares Mean
755379|NCT00593736|Secondary|Subjective Number of Awakenings Measured by a Post-sleep Questionnaire (Nights 6-7)|Subjective number of awakenings was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, “Did you wake up during the night? If “yes”, how many times do you think you woke up?”|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||number of awakenings||Standard Error|Least Squares Mean
755380|NCT00593736|Secondary|Subjective Wake Time After Sleep Onset Measured by a Post-sleep Questionnaire (Nights 13-14)|Subjective wake time after sleep onset was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, “Did you wake up during the night? If “yes”, what is the total time you think you were awake?”|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||minutes||Standard Error|Least Squares Mean
755381|NCT00593736|Secondary|Subjective Wake Time After Sleep Onset Measured by a Post-sleep Questionnaire (Nights 6-7)|Subjective wake time after sleep onset was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, “Did you wake up during the night? If “yes”, what is the total time you think you were awake?”|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||minutes||Standard Error|Least Squares Mean
755382|NCT00593736|Secondary|Subjective Total Sleep Time Measured by a Post-sleep Questionnaire (Nights 13-14)|Subjective total sleep time was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, “How long (total hours and minutes) do you think you slept last night?”|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||minutes||Standard Error|Least Squares Mean
755383|NCT00593736|Secondary|Subjective Total Sleep Time Measured by a Post-sleep Questionnaire (Nights 6-7)|Subjective total sleep time was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, “How long (total hours and minutes) do you think you slept last night?”|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||minutes||Standard Error|Least Squares Mean
755384|NCT00593736|Secondary|Subjective Sleep Latency Measured by a Post-sleep Questionnaire (Nights 13-14)|Subjective sleep latency was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, “How long do you think it took you to fall asleep last night?”|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||minutes||Standard Error|Least Squares Mean
755385|NCT00593736|Secondary|Subjective Sleep Latency Measured by a Post-sleep Questionnaire (Nights 6-7)|Subjective sleep latency was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, “How long do you think it took you to fall asleep last night?”|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||minutes||Standard Error|Least Squares Mean
755386|NCT00593736|Secondary|Wake Time Measured by Actigraphy (Nights 13-14)|Clock time subject wakes up (recorded by actigraphy watch worn by subject). Units are hours and minutes on a 24-hour clock, expressed in decimal time.|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||hours on a 24-hour clock||Standard Error|Least Squares Mean
755387|NCT00593736|Secondary|Wake Time Measured by Actigraphy (Nights 6-7)|Clock time subject wakes up (recorded by actigraphy watch worn by subject). Units are hours and minutes on a 24-hour clock, expressed in decimal time.|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||hours on a 24-hour clock||Standard Error|Least Squares Mean
755388|NCT00593736|Secondary|Sleep Time Measured by Actigraphy (Nights 13-14)|Clock time subject goes to sleep (recorded by actigraphy watch worn by subject). Units are hours and minutes on a 24-hour clock, expressed in decimal time.|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||hours on a 24-hour clock||Standard Error|Least Squares Mean
755389|NCT00593736|Secondary|Sleep Time Measured by Actigraphy (Nights 6-7)|Clock time subject goes to sleep (recorded by actigraphy watch worn by subject). Units are hours and minutes on a 24-hour clock, expressed in decimal time.|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||hours on a 24-hour clock||Standard Error|Least Squares Mean
755390|NCT00593736|Secondary|Sleep Latency Measured by Actigraphy (Nights 13-14)|The elapsed time from the beginning of the recording to the onset of the first 10 minutes of continuous sleep (recorded by actigraphy watch worn by subject).|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||minutes||Standard Error|Least Squares Mean
755391|NCT00593736|Secondary|Sleep Latency Measured by Actigraphy (Nights 6-7)|The elapsed time from the beginning of the recording to the onset of the first 10 minutes of continuous sleep (recorded by actigraphy watch worn by subject).|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||minutes||Standard Error|Least Squares Mean
755392|NCT00593736|Secondary|Wake Bouts Measured by Actigraphy (Nights 13-14)|The number of wake bouts pertains to the total number of continuous blocks (recorded by actigraphy watch worn by subject), with one or more epochs in duration, and with each epoch of each clock scored as WAKE between the start time and the end time of the given interval.|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||wake bouts||Standard Error|Least Squares Mean
755393|NCT00593736|Secondary|Wake Bouts Measured by Actigraphy (Nights 6-7)|The number of wake bouts pertains to the total number of continuous blocks (recorded by actigraphy watch worn by subject), with one or more epochs in duration, and with each epoch of each clock scored as WAKE between the start time and the end time of the given interval.|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||wake bouts||Standard Error|Least Squares Mean
755394|NCT00593736|Secondary|Wake Time During Sleep Interval Measured by Actigraphy (Nights 13-14)|Wake time during sleep is the total number of epochs (number of movements recorded by actigraphy watch worn by subject) between the start time and the end time of the given sleep interval, scored as WAKE by the software (or manually set as WAKE by the practitioner using the software), multiplied by the Epoch length in minutes.|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||minutes||Standard Error|Least Squares Mean
755395|NCT00593736|Secondary|Wake Time During Sleep Interval Measured by Actigraphy (Nights 6-7)|Wake time during sleep is the total number of epochs (number of movements recorded by actigraphy watch worn by subject) between the start time and the end time of the given sleep interval, scored as WAKE by the software (or manually set as WAKE by the practitioner using the software), multiplied by the Epoch length in minutes.|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||minutes||Standard Error|Least Squares Mean
755396|NCT00593736|Secondary|Sleep Efficiency Measured by Actigraphy (Nights 13-14)|Sleep efficiency pertains to the scored total sleep time (recorded by actigraphy watch worn by subject) of the sleep interval divided by total time in bed minus total invalid time (Sleep/Wake), multiplied by 100.|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||percentage of time asleep||Standard Error|Least Squares Mean
755397|NCT00593736|Secondary|Sleep Efficiency Measured by Actigraphy (Nights 6-7)|Sleep efficiency pertains to the scored total sleep time (recorded by actigraphy watch worn by subject) of the sleep interval divided by total time in bed minus total invalid time (Sleep/Wake), multiplied by 100.|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||percentage of time asleep||Standard Error|Least Squares Mean
755398|NCT00593736|Secondary|Total Sleep Time Measured by Actigraphy (Nights 13-14)|Total sleep time pertains to the total number of epochs (number of movements recorded by actigraphy watch worn by subject) that are less than or equal to 40, measured between the start time and end time during the nocturnal sleep interval, scored as SLEEP by the actigraphy software.|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||minutes||Standard Error|Least Squares Mean
755399|NCT00593736|Secondary|Total Sleep Time Measured by Actigraphy (Nights 6-7)|Total sleep time calculated using the total number of epochs (number of movements recorded by actigraphy watch worn by subject) that are less than or equal to 40, measured between the start time and end time during the nocturnal sleep interval, scored as SLEEP by the actigraphy software.|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||minutes||Standard Error|Least Squares Mean
755400|NCT00593736|Secondary|Wake Time Over a 2-night Average Measured by Polysomnography (Nights 13-14)|Wake Time was measured as the clock time that the subject got up in the morning. Units are hours and minutes on a 24-hour clock, expressed in decimal time.|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||hours on a 24-hour clock||Standard Error|Least Squares Mean
755401|NCT00593736|Secondary|Wake Time Over a 2-night Average Measured by Polysomnography (Nights 6-7)|Wake Time was measured as the clock time that the subject got up in the morning. Units are hours and minutes on a 24-hour clock, expressed in decimal time.|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||hours on a 24-hour clock||Standard Error|Least Squares Mean
755402|NCT00593736|Secondary|Sleep Time Over a 2-night Average Measured by Polysomnography (Nights 13-14)|Sleep time was measured as the clock time the subject went to sleep. Units are hours and minutes on a 24-hour clock, expressed in decimal time.|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||hours on a 24-hour clock||Standard Error|Least Squares Mean
755403|NCT00593736|Secondary|Sleep Time Over a 2-night Average Measured by Polysomnography (Nights 6-7)|Sleep time was measured as the clock time the subject went to sleep. Units are hours and minutes on a 24-hour clock, expressed in decimal time.|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||hours on a 24-hour clock||Standard Error|Least Squares Mean
755404|NCT00593736|Secondary|Total Wake Time Over a 2-night Average Measured by Polysomnography (Nights 13-14)|The sum of all the minutes of Stage Wake from the beginning of the recording to the end of recording.|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||minutes||Standard Error|Least Squares Mean
755405|NCT00593736|Secondary|Total Wake Time Over a 2-night Average Measured by Polysomnography (Nights 6-7)|The sum of all the minutes of Stage Wake from the beginning of the recording to the end of recording.|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||minutes||Standard Error|Least Squares Mean
755406|NCT00593736|Secondary|Number of Awakenings Over a 2-night Average Measured by Polysomnography (Nights 13-14)|The number of times after onset of persistent sleep that there is a wake entry of at least 2 epochs in duration. Each entry must be separated by stage 2, stage 3/4 non-REM (NREM) sleep, or REM sleep to be counted.|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||number of awakenings||Standard Error|Least Squares Mean
755407|NCT00593736|Secondary|Number of Awakenings Over a 2-night Average Measured by Polysomnography (Nights 6-7)|The number of times after onset of persistent sleep that there is a wake entry of at least 2 epochs in duration. Each entry must be separated by stage 2, stage 3/4 non-REM (NREM) sleep, or REM sleep to be counted.|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||number of awakenings||Standard Error|Least Squares Mean
755471|NCT00594230|Secondary|Hematologic Improvement, Including Transfusion Independence|"Hematologic measures will include total WBC and platelets
NOTE: Study terminated early, no results are available for this endpoint"|Every 8 weeks up to 24 months on-study||||||
755408|NCT00593736|Secondary|Wake Time After Sleep Onset Over a 2-night Average Measured by Polysomnography (Nights 13-14)|The number of wake minutes after the onset of persistent sleep prior to the end of recording.|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||minutes||Standard Error|Least Squares Mean
755409|NCT00593736|Secondary|Wake Time After Sleep Onset Over a 2-night Average Measured by Polysomnography (Nights 6-7)|The number of wake minutes after the onset of persistent sleep prior to the end of recording.|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||minutes||Standard Error|Least Squares Mean
755410|NCT00593736|Secondary|Sleep Efficiency Over a 2-night Average Measured by Polysomnography (0-8 Hours) (Nights 13-14)|The total sleep time divided by time-in-bed, multiplied by 100.|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||percentage of time asleep||Standard Error|Least Squares Mean
755411|NCT00593736|Secondary|Sleep Efficiency Over a 2-night Average Measured by Polysomnography (0-8 Hours) (Nights 6-7)|The total sleep time divided by time-in-bed, multiplied by 100.|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||percentage of time asleep||Standard Error|Least Squares Mean
755412|NCT00593736|Secondary|Sleep Efficiency Over a 2-night Average Measured by Polysomnography (0-3 Hours) (Nights 13-14)|The total sleep time divided by time-in-bed, multiplied by 100.|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||percentage of time asleep||Standard Error|Least Squares Mean
755413|NCT00593736|Secondary|Sleep Efficiency Over a 2-night Average Measured by Polysomnography (0-3 Hours) (Nights 6-7)|The total sleep time divided by time-in-bed, multiplied by 100.|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||percentage of time asleep||Standard Error|Least Squares Mean
755414|NCT00593736|Secondary|Total Sleep Time Over a 2-night Average Measured by Polysomnography (Nights 13-14)|The sum of all of the minutes of Stages 1, 2, 3, 4, and REM sleep.|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||minutes||Standard Error|Least Squares Mean
755415|NCT00593736|Secondary|Total Sleep Time Over a 2-night Average Measured by Polysomnography (Nights 6-7)|The sum of all of the minutes of Stages 1, 2, 3, 4, and rapid eye movement (REM) sleep.|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||minutes||Standard Error|Least Squares Mean
755416|NCT00593736|Secondary|Latency to Persistent Sleep Over a 2-night Average Measured by Polysomnography (Nights 13-14)|The elapsed time from the beginning of the polysomnography recording to the onset of the first 10 minutes of continuous sleep (ie, total number of epochs before the first 20 consecutive non-wake epochs divided by 2).|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||minutes||Standard Error|Least Squares Mean
755417|NCT00593736|Primary|Latency to Persistent Sleep Over a 2-night Average Measured by Polysomnography (Nights 6-7)|The elapsed time from the beginning of the polysomnography recording to the onset of the first 10 minutes of continuous sleep (ie, total number of epochs before the first 20 consecutive non-wake epochs divided by 2).|Nights 6-7|Analysis was conducted on the full analysis set (FAS), which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||minutes||Standard Error|Least Squares Mean
755418|NCT00593814|Secondary|Device Efficacy Events||2 years||||||
755419|NCT00593814|Primary|Number of Subjects With Aneurysm Volume Increase Greater Than 10% at 2 Years Post-procedure||2 years|||participants|||Number
755420|NCT00593827|Secondary|Incidence of All Grades of Peripheral Neuropathy|All events of peripheral neuropathy were assessed and graded per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3. CTC Grade (GR) 1=Mild; GR2=Moderate; GR3=Severe or medically significant, not immediately life-threatening; and GR4=Life-threatening. All treatment-related and not related Neuropathy and Peripheral Neuropathy were included; serious adverse events (SAEs) were not included.|Assessed from the date of first study dose until at least 30 days after the last dose of study drug. Median time on study therapy was 12 weeks (range: 4-60 weeks for 16 mg/m^2 arm; 3-87 weeks for 40 mg/m^2 arm).|Safety population.||Participants|||Number
755421|NCT00593827|Other Pre-specified|Number of Participants With Death as Outcome, Treatment-related (TR) Deaths, SAEs, TR SAEs, Adverse Events (AEs) Leading to Discontinuation, AEs, TR AEs, GR 3-4 AEs, TR GR 3-4 AEs, Drug-related (DR) Peripheral Neuropathy, Neutropenia, Alopecia|An AE is any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, drug dependency or abuse; is life-threatening, an important medical event, a congenital anomaly/birth defect; requires inpatient hospitalization; or prolongs existing hospitalization. Treatment related=possibly, probably, or certainly related to and of unknown relationship to study treatment. GR=Grade.|Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on study therapy was 12 weeks (range: 4-60 weeks for 16 mg/m^2 arm; 3-87 weeks for 40 mg/m^2 arm).|"ITT population: Participants randomized on the study (eligible and ineligible). AEs, AEs leading to death and GR 3-4 AEs: Safety population-Participants who received atleast 1 dose of study drug).
AEs leading to death: For 4 participants in Arm 1 and both participants in Arm 2, the reported AE term was disease progression."||Participants|||Number
755422|NCT00593827|Secondary|Duration of Response|Duration of overall response was defined as the period from the time first PR or CR was recorded until the first date of documented PD or death. Duration of response was computed for participants whose best response was either PR or CR. Participants who neither relapsed nor died were censored on the date of their last tumor assessment. Kaplan-Meier method was used to estimate the duration of response. Refer to outcome measures 3 and 4 for CR, PR, and PD.|From the date of first PR or CR assessment to date of progression, death, or last tumor assessment (maximum participant duration of response of 17.4 months)|ITT population with CR or PR.||Months||95% Confidence Interval|Median
755423|NCT00593827|Secondary|Time to Response|"Time to response is defined as the time from the start of treatment until the first (confirmed) CR or PR was recorded. Time to response was computed only for participants whose best response was PR or CR.
CR: Disappearance of all target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (LD) of all target lesions with reference to the baseline sum LD."|From the date of first dose to date of first PR or CR assessment ( maximum participant time to response of 8.3 months)|ITT population with CR or PR.||Months||Full Range|Median
755424|NCT00593827|Secondary|Overall Survival (OS)|"Survival was measured as the date of randomization to the date of death. Participants who were alive at the time of the database lock or lost to follow-up were censored at the last known alive date. The distribution of overall survival was analyzed via the Kaplan Meier method in each arm.
Survival time (months) = (End date – date of randomization + 1)/30.4375"|From the date of randomization to date of death (maximum participant OS of 26.3 months)|ITT population: Participants who were randomized on the study (eligible and ineligible).||Months||95% Confidence Interval|Median
755425|NCT00593827|Secondary|Best Response as Assessed With RECIST|Determined based on the sequence of disease status with corresponding best response. PD=At least a 20% increase in the sum of LD of target lesions in reference to the smallest sum LD recorded or the appearance of 1 or more new lesions; SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD in reference to the smallest sum LD. NE=Participants who discontinued treatment secondary to toxicity or died (either before completion of 1 treatment cycle). Please refer outcome measure 3 for explanation of CR and PR. CR+PR+SD=overall disease control.|Assessed at 12-week intervals until disease progression (to a maximum follow-up for tumor response of 26.3 months)|Evaluable population: All treated participants with CR, PR, SD, PD, or NE response and who had received at least 1 dose of study drug.||Percentage of Participants||95% Confidence Interval|Number
755426|NCT00593827|Secondary|Overall Response Rate (ORR) Based on Response Criteria in Solid Tumors [RECIST]|"ORR is defined as the proportion of responders (complete response [CR] + partial response [PR] in participants with measurable disease) in that arm among all randomized participants.
CR: Disappearance of all evidence of target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (LD) of all target lesions.
Measurable disease: Lesions that can be accurately measured in at least one dimension (LD to be recorded) as ≥20 mm with conventional techniques (computed tomography [CT], magnetic resonance imaging [MRI], X-ray) or as ≥10 mm with spiral CT scan."|Assessed at 12-week intervals until disease progression (to a maximum follow-up for tumor response of 26.3 months)|Evaluable population-All treated participants with CR, PR, stable disease (SD), progressive disease (PD), or nonevaluable (NE) response and who had received at least 1 dose of study drug. Please refer outcome measure 4 for explanation of SD, PD, and NE.||Percentage of Participants||95% Confidence Interval|Number
755427|NCT00593827|Secondary|Median Progression Free Survival|PFS is defined as time interval from the date of randomization to the date of (first) progression or date of death. Participants who progressed or died were counted as events. Participants lost to follow-up were censored as of the last date of contact. Participants who started a new treatment before they progressed were censored as of the date of start of the new treatment. Participants who had not progressed or died were censored at the date of last follow-up. PFS (months) = (End date – date of randomization + 1)/30.4375.|From the date of randomization to date of progression, death, or last tumor assessment (maximum participant PFS of 25.7 months)|ITT population: Participants who were randomized on the study (eligible and ineligible).||Months||95% Confidence Interval|Median
755428|NCT00593827|Primary|Progression-Free Survival (PFS) at 6 Months (6-month PFS Rate): Proportion of Participants Progression Free at 6 Months|PFS at 6 months was defined as proportion of participants who neither progressed nor died before 6 months. Computed using Kaplan-Meier estimates.|From the date of randomization to 6-months on study|ITT population: Participants who were randomized on the study (eligible and ineligible).||Percentage of Participants||95% Confidence Interval|Number
755429|NCT00593840|Post-Hoc|Kaplan Meier Estimate of Progression-free Survival|-Progression is defined using Response Evaluation Criteria in Solid Tumors (RECIST 1.0) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|3 years|||percentage of participants-Kaplan Meier|||Number
755430|NCT00593840|Post-Hoc|Kaplan Meier Estimate of Regional Recurrence Free Survival|-Recurrence is defined as the return of cancer after treatment|3 years|||percentage of participants-Kaplan Meier|||Number
755431|NCT00593840|Secondary|Patterns of Failure Associated With Implementation of Primary Objective|For patients who demonstrate a local failure during follow-up, a computed tomography (CT), positron emission tomography (PET)/CT, or magnetic resonance imagine (MRI) scan is fused with the original treatment planning CT scan using the computational environment for radiation research (CERR) developed at Washington University Medical Center. The methodology to transfer the digital imaging study via network to the radiation therapy research servers is mature. The original dose distribution and contours are correlated with the recurrent disease noted on the follow up imaging study. The recurrence is then classified as infield, marginal to the treatment field, or out of the treatment field depending on the dose received by the recurrent disease. Failures that occur in the treatment field are due to aspects of tumor biology rather than errors in the volume irradiated. As has been the case in our historical controls, the investigators expect most failures to be in the treatment field.|5 years from completion of treatment||04/2020||||
755432|NCT00593840|Secondary|Kaplan Meier Estimate of Overall Survival||3 years|||percentage of participants-Kaplan Meier|||Number
755433|NCT00593840|Secondary|Disease Specific Survival Rate||5 years from completion of treatment||04/2020||||
755434|NCT00593840|Secondary|Compare Standard Treatment Volume (CTV and PTV) With Protocol Defined Treatment Volume in Terms of Organ Specific Dose Volume Histograms||5 years from completion of treatment||04/2020||||
755435|NCT00593840|Secondary|Quality of Life (QOL) as Measured by Xerostomia QOL Data|-The Quality of Life (QOL) Evaluation (Swallowing and Dryness Questionnaire) will be used. 20 questions with answers of Strongly Agree to Strongly Disagree. Xerostomia score was scaled for a total xerostomia score from 0 to 100 with 0 being the worst QOL and 100 the best QOL.|Median follow-up was 22 months|||units on a scale||Standard Deviation|Mean
755517|NCT00594425|Secondary|Proportion of Patients With Mild and Moderate Erythema After First Treatment||2 days after first treatment|Safety||percentage of participants|||Number
755518|NCT00594425|Secondary|Proportion of Patients With Mild and Moderate Erythema After First Treatment||immediately after first treatment|Safety||percentage of participants|||Number
755436|NCT00593840|Secondary|Quality of Life (QOL) as Measured by Overall Global QOL Scores|-The Quality of Life (QOL) Evaluation (Swallowing and Dryness Questionnaire) will be used. 20 questions with answers of Strongly Agree to Strongly Disagree. Global score was scaled for a total score from 0 to 100 with 0 being the worst QOL and 100 the best QOL.|Median follow-up was 22 months|65 out of 73 patients had evaluable QOL data in Arm 1.||units on a scale||Standard Deviation|Mean
755437|NCT00593840|Secondary|Kaplan Meier Estimate of Locoregional Recurrence Free Survival|"Recurrence is defined as the return of cancer after treatment
Kaplan Meier Estimate of the percentage of participants whose cancer has not returned locoregionally in the specified time frame"|3 years|||percentage of participants-Kaplan Meier|||Number
755438|NCT00593840|Primary|Number of Participants With a Recurrence in the Unirradiated Neck(s)|"Recurrence in a PN0 neck that was not treated is the critical endpoint in this study.
Recurrence is defined as the return of cancer after treatment
Recurrence is determined by a CT, PET/CT, or MRI and it will be fused with the original treatment planning CT scan. This will allow correlation between the original dose distribution and contours with any recurrent disease."|12 months of follow-up|||participants||95% Confidence Interval|Number
755439|NCT00593866|Secondary|The Percentage of Participants Free From Local Progression at 2 Years||2 Years|||percentage of participants||95% Confidence Interval|Number
755440|NCT00593866|Primary|The Maximum Tolerated Radiation Dose|The maximum tolerated radiation dose delivered with intensity-modulated radiotherapy (IMRT) and concurrent gemcitabine in patients with unresectable adenocarcinoma of the pancreas.|13 weeks post radiation|||Gray (Gy)|||Number
755441|NCT00593918|Primary|Percentage of Participants With Detected Nasal Interferon (IL)-2 Cytokine Expression|IL-2 measured from nasal lavage samples by Luminex multiplex assay|1-5 days during acute illness (not after day 5 of illness)|||Percentage of Participants|||Number
755442|NCT00593918|Primary|Nasal Interferon (IFN)-a2|Interferon a2 was measured from nasal lavage samples by Luminex multiplex assay.|1-5 days during acute illness (not after day 5 of illness)|Analysis was per protocol based on the number of children enrolled by genotype and completed nasal washes at first visit.||pg/ml||Standard Deviation|Mean
755443|NCT00593957|Secondary|Mean SSI Score for Total Subjects at Baseline and 6 Months|Analysis of Difference in Mean Screen for Social Interaction (SSI) Score between 0-6 months for total sample (n=19).|0-6 months|19 subjects (total sample) for whom complete data was available||scores on a scale||Standard Deviation|Mean
755444|NCT00593957|Secondary|Difference in SSI Mean Score at Six Months Compared to Baseline for Each Treatment Arm.|The Screen for Social Interaction (SSI) is a 54-item parent/caregiver-report screening instrument that emphasizes reciprocal social interaction including joint attention skills. The items are positive (prosocial) and are scored on a four-point frequency scale (child displays the behavior “almost never” = 0 to “almost all the time” = 3). Thus lower scores reflect a slower or delayed development, and higher scores reflect more normative development. SSI total scores range from 0-162. There are no subscales. Difference in Screen for Social Interaction (SSI) mean scores between baseline and 6 months post-treatment for each treatment arm are reported.|Initial and 6 month followup|Those who provided complete information only were included. Others did not provide adequate or complete information for analysis.||scores on a scale||Standard Deviation|Mean
755445|NCT00593957|Secondary|Improvement in Receptive Language as Measured by the Mullen Scale.|The Mullen Receptive language scale pre and 6 months post DM, measured as a change in the mean score of language, by age in months.|Change in mean between Initial and 6-month follow-up|25/35 enrolled participants completed the receptive language scale of the Mullen and underwent the analysis.||age in months||Standard Deviation|Mean
755446|NCT00593957|Primary|Difference in EEG Spike Counts at Six Months Compared to Baseline for Each Treatment Arm.|Difference in EEG spike count means pre and 6 months post-treatment in each of three treatment groups.|Initial and 6-month post-treatment|33/35 participants who completed the protocol with two epochs of 5 mins of non-Rapid eye movement (REM)sleep during which spikes could be counted pre and post DM intake.||EEG spike counts per minute||Standard Deviation|Mean
755447|NCT00594022|Secondary|Scored Sleep Onset Latency (SOL on PSG)||Treatment Night|It was noted on initial evaluation of the results, that Site 6 indicate that there are properties of either the population or the study site that make it different from the remaining sites. For this reason, the analysis of the primary and secondary endpoints of the trial were done with Site 6 excluded.||minutes||Standard Deviation|Mean
755448|NCT00594022|Secondary|Total Sleep Time (TST) in the First Hour After Lights Out||Treatment night|It was noted on initial evaluation of the results, that Site 6 indicate that there are properties of either the population or the study site that make it different from the remaining sites. For this reason, the analysis of the primary and secondary endpoints of the trial were done with Site 6 excluded.||minutes||Standard Deviation|Mean
755449|NCT00594022|Secondary|Total Sleep Time (TST) in the First 2 Hours After Lights Out||Treatment night|It was noted on initial evaluation of the results, that Site 6 indicate that there are properties of either the population or the study site that make it different from the remaining sites. For this reason, the analysis of the primary and secondary endpoints of the trial were done with Site 6 excluded.||minutes||Standard Deviation|Mean
755450|NCT00594022|Secondary|Subjective Sleep Onset Latency (SOL)||Treatment night|It was noted on initial evaluation of the results, that Site 6 indicate that there are properties of either the population or the study site that make it different from the remaining sites. For this reason, the analysis of the primary and secondary endpoints of the trial were done with Site 6 excluded.||minutes||Standard Deviation|Mean
755451|NCT00594022|Primary|Latency to Persistent Sleep (LPS)||Treatment Night|Only 282 of the Polysomnography results were scorable. 132 for the treatment (stim group) and 150 for the sham group.||minutes||Standard Deviation|Mean
755452|NCT00594035|Primary|Watertight Dural Closure|Number of subjects displaying a watertight dural closure after assigned treatment intra-operatively.|Intra-Operative|||Participants|||Number
755453|NCT00594100|Secondary|Patency at 30 Days|Number of participants with less than 50% restenosis as determined by carotid duplex ultrasound core laboratory at 30 days post-procedure.|Treatment through 30-day visit window|Subjects with successful stent placement and ultrasound evaluation at 30-day follow-up evaluation.||participants|||Number
755519|NCT00594425|Secondary|Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain.|Measure was assessed on a Visual Analogue Scale from 0 to 10 cm|immediately after illumination-fourth treatment treatment|Safety||cm||Full Range|Median
755454|NCT00594100|Secondary|Clinical Success|Number of participants with Flow Reversal System and Stent Success in the absence of death, emergency endarterectomy, repeat percutaneous transluminal angioplasty (PTA)/thrombolysis of the target vessel, stroke, or myocardial infarction (MI), as determined by the Clinical Events Committee (CEC).|24-48 Hours Post-Procedure|All enrolled subjects with post procedure angiographic assessment of lesion stenosis||participants|||Number
755455|NCT00594100|Secondary|Stent Success|Number of participants where the FDA-approved stent was successfully delivered, deployed,and delivery system removed with an attainment of < 50% residual stenosis following stent placement, as assessed by the angiographic core laboratory.|Procedure|All enrolled subjects with post procedure angiographic assessment of lesion stenosis||participants|||Number
755456|NCT00594100|Secondary|Flow Reversal System Success|Number of participants where the GORE Flow Reversal System was delivered, placed, reverse flow was established, and the balloon sheath and wire retrieved as outlined in the Instructions for Use without causing any adverse events during the procedure.|Procedure|||participants|||Number
755457|NCT00594100|Secondary|Flow Reversal System Technical Success|Number of participants with Technical Success using the GORE Flow Reversal System (system deployed and utilized during stenting procedure)|Procedure|All enrolled subjects||participants|||Number
755458|NCT00594100|Primary|Composite Major Adverse Event (MAE) Rate|Number of participants with one or more Major Adverse Event (death, stroke, myocardial infarction, and/or transient ischemic attack (TIA)) through the 30-day follow-up (non-hierarchical; MAE adjudicated by independent Clinical Events Committee)|Treatment through 30-day visit window|All primary endpoint evaluable subjects||participants|||Number
755459|NCT00594165|Secondary|Mean Epworth Sleepiness Scale Score During the Open-label Extension.|The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire with 8 questions. The total ESS score is the sum of 8 item-scores and can range between 0 and 24. The higher the score, the higher the person’s level of daytime sleepiness.|Visit 9 (end of year 1), Visit 13 (end of year 2), Visit 17 (end of year 3), Visit 21(end of year 4), Visit 25 (end of year 5), Visit 29 (end of year 6), End of Treatment (last study visit or early withdrawal visit)|Of the 217 subjects who entered the study, 216 are included in this summary based on the Safety Set (SS). Subject 10806 received SP512OL study medication at the final visit of SP512DB but never returned to the clinic; this subject is excluded from the Safety Set. Last observation carried forward (LOCF) was utilized.||Score on a scale||Standard Deviation|Mean
755460|NCT00594165|Secondary|Number of Subjects Who Withdrew From the Trial Due to an Adverse Event.|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|7 years|Of the 217 subjects who entered the study, 216 are included in this summary based on the Safety Set (SS). Subject 10806 received SP512OL study medication at the final visit of SP512DB but never returned to the clinic; this subject is excluded from the Safety Set.||subjects|||Number
755461|NCT00594165|Primary|Number of Subjects With at Least One Adverse Event During This Open-label Extension Study|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|7 years|Of the 217 subjects who entered the study, 216 are included in this summary based on the Safety Set (SS). Subject 10806 received SP512OL study medication at the final visit of SP512DB but never returned to the clinic; this subject is excluded from the Safety Set.||Subjects|||Number
755462|NCT00594178|Secondary|Bone Density Via Dual-Energy X-ray Absortiometry (DEXA) Scan|Bone mineral density was measured with Dual-Energy X-ray Absortiometry (DEXA) scan pre and post, three month exercise protocol on a passive motorized exercise bicycle.|baseline and 3 months Post-exercise|||grams/cm^2||Standard Deviation|Mean
755463|NCT00594178|Primary|Muscle Mass Via Dual-Energy X-ray Absortiometry (DEXA)Scan Data|Lean muscle mass was measured with Dual-Energy X-ray Absortiometry (DEXA) scan, which uses low dose radiation to assess bone density and soft tissue density. pre and post, three month exercise protocol on a passivie motorized exercise bicycle.|baseline and 3 months|analysis per protocol||grams||Standard Deviation|Mean
755464|NCT00594204|Primary|Number of Participants With 4-week Continuous Abstinence|The number of participants who, at each visit from Week 9 through 12 (inclusive), reported no smoking and no use of other nicotine-containing products since the last study visit (on the Nicotine Use Inventory) and who did not have carbon monoxide (CO) > 10 parts per milion (ppm) at any of these visits|Weeks 9 through 12|Intent-to-treat (ITT)||participants|||Number
755465|NCT00594204|Secondary|Number of Participants With Seven-day Point Prevalence of Abstinence|Number of participants who, at the given visit or telephone contact, reported no smoking and no use of other nicotine-containing products (treatment phase) or tobacco products (non-treatment phase) in the last 7 days and who did not have CO >10 ppm on that day|Week 12 and 24|ITT||participants|||Number
755466|NCT00594204|Secondary|Number of Participants With Continuous Abstinence|The number of participants who, at each contact from Week 9 through the given timepoint, reported no smoking and no use of other nicotine-containing products (Treatment Phase) or tobacco products (Nontreatment Phase) since the last study contact(on the Nicotine Use Inventory) and who did not have CO > 10 ppm|Weeks 9 through 24|ITT||participants|||Number
755467|NCT00594230|Secondary|Safety and Tolerability of LBH589 in Patients With Relapsed/Refractory MDS|NOTE: Study terminated early, no results are available for this endpoint|24 months||||||
755468|NCT00594230|Secondary|Median Overall Survival|"The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death
NOTE: Study terminated early, no results are available for this endpoint"|24 months on-study, patients followed every 3 months in follow-up||||||
755469|NCT00594230|Secondary|Median Time to Treatment Failure|"Time to treatment failure is defined as measuring the time between cycle 1 day 1 to discontinuation for any reason.
NOTE: Study terminated early, no results are available for this endpoint"|24 months||||||
755470|NCT00594230|Secondary|Duration of Response|"Duration of response is defined as the time from when objective response is realized until time to first documented disease progression. Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Objective Response = CR + PR. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.
NOTE: Study terminated early, no results are available for this endpoint"|Every 8 weeks up to 24 months on-study||||||
755472|NCT00594230|Secondary|Time to Disease Progression|"Time to disease progression is defined as the time between day 1 cycle 1 and time to first documented disease progression. Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
NOTE: Study terminated early, no results are available for this endpoint"|Every 8 weeks up to 24 months on-study, every 3 months in follow-up until progression of disease||||||
755473|NCT00594230|Primary|Overall Response Rate (CR, Marrow CR + PR) of LBH in Patients With Relapsed or Refractory MDS.|Overall response rate (ORR) is defined by the modified International Working Group (IWG) Response Criteria for MDS. In the marrow, Complete Response (CR) is <= 5% blasts present with normal maturation of all cell lines. In peripheral blood, CR is defined as hemoglobin >= 11 g/dL, ANC >= 1000/mL, and platelets >= 100,000 with 0% blasts present. Partial Response (PR) is defined the same as CR with blasts decreased by >= 50% and >= 5% blasts in the marrow.|Every 8 weeks up to 24 months on-study.|All evaluable patients assessed for response prior to early study termination - one patient in each arm was not evaluable due to coming off-study prior to assessment||participants|||Number
755474|NCT00594256|Secondary|Slow Wave Sleep Minutes|Overnight sleep study: Subjects will undergo polysomnography four times during this study, on consecutive nights during the observation week and on consecutive nights at the end. Polysomnography will be performed in a modified seclusion room on the in patient unit. The first of the consecutive nights will be used for adaptation to the study conditions. Sleep was recorded between lights off (10 pm) and lights on (at 6:45 am). We aim for conditions for falling asleep as comfortable as possible under the experimental condition.|1 month|4 pre post||minutes||Standard Deviation|Mean
755475|NCT00594256|Secondary|MATRICS Neurocognitive Battery Composite|This is a series of neurocognitive tests developed by the National Institute of Mental Health to evaluate medications targeting cognition in an efficient and reliable manner. It will be modified by the deletion of the social competence domain. The six domains include speed of processing, attention/vigilance, working memory, verbal learning, visual learning and reasoning/problem solving. The primary outcome will be the mean T-score (mean of six domains).|1 month|||Composite T-score||Standard Deviation|Mean
755476|NCT00594256|Secondary|Positive and Negative Syndrome Scale (PANSS) Negative Factor|The PANSS Negative factor is a 7-item rating scale widely used in the assessment of schizophrenia. Range is 7-49 with higher scores worse|1 month|Paired t test of baseline and final values||mean decrease in negative subscale||Standard Deviation|Mean
755477|NCT00594256|Primary|Epworth Sleepiness Scale|Designed to measure daytime sleepiness. 8 items rated 0-3, with higher scores associated with a greater daytime sleepiness. overall score rated 0-24, with scores greater than 10 indicating significant daytime sleepiness.|1 month|||global score||Standard Deviation|Mean
755478|NCT00594256|Primary|Pittsburgh Sleep Quality Index|This rating scale generates a global sleep-quality score, as well as scores on 7 components of sleep quality: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The 19 items are combined to form seven “component” scores, each of which has a range of O-3 points. The seven component scores are then added to yield one “global” score, with a range of O-21 points, “0” indicating no difficulty and “21” indicating severe difficulties in all areas.|1 month|ITT||global score||Standard Deviation|Mean
755479|NCT00594308|Secondary|Patients Who Experience Serious Transplant Related Toxicities as Evaluated by Bone Marrow Transplant-adjusted NCI Common Toxicity Criteria.|Number of patients who died due to transplant related toxicities|up to 2 years after stem cell transplant|Intent To Treat: All patients that received study drug||participants|||Number
755480|NCT00594308|Secondary|Time to Resolution of Cytopenias: Platelet Transfusion Independence|Average number of days per patient for resolution of cytopenias.|From Day -1 (day before stem cell infusion) to Day +20 (20 days after stem cell infusion)|IIT: All patients that received study drug.||days per patient||Standard Deviation|Mean
755481|NCT00594308|Secondary|Number of Days for Absolute Neutrophil Count to Recover|Average number of day per patient for absolute neutrophil count to recover(> 500/mm3 for 3 consecutive days).|From Day -1 (day before stem cell infusion) to Day+20 (20 days after stem cell infusion)|ITT: All patient that received study drug||days per patient||Standard Deviation|Mean
755482|NCT00594308|Secondary|Number of Patients Engrafting at Day +30 by Short Tandem Repeat (STR) on Peripheral Blood Mononuclear Cells (PBMC's).||until 30 days after stem cell transplant|ITT population. All patient that received study drug||participants|||Number
755483|NCT00594308|Primary|Number of Patients With Acute Grade II-IV GVHD|Number of patients with Grade II-IV GVHD according to NMDP/CIBMTR GVHD severity scale. This scale measures the degree of GVHD involvement in the patient's skin (inflammatory skin disease), liver (bilirubin levels) and intestinal tract (amount of diarrhea) as well as the level of decline in a patient's activity and physical abilities.|until 30 days after stem cell transplant|All patient that received study drug||participants|||Number
755484|NCT00594386|Secondary|Mean Epworth Sleepiness Scale Score During the Open-label Extension.|The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire with 8 questions. The total ESS score is the sum of 8 item-scores and can range between 0 and 24. The higher the score, the higher the person's level of daytime sleepiness.|Visit 11 (end of year 1), Visit 15 (end of year 2), Visit 19 (end of year 3), Visit 23 (end of year 4), Visit 27 (end of year 5), Visit 31 (end of year 6), End of Treatment (last study visit or early withdrawal visit)|Of the 258 subjects who entered the study, 258 are included in this summary based on the Safety Set (SS). Last observation carried forward (LOCF) was utilized.||Score on a scale||Standard Deviation|Mean
755485|NCT00594386|Secondary|Number of Subjects Who Withdrew From the Trial Due to an Adverse Event.|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|6 years|Of the 258 subjects who entered the study, 258 are included in this summary based on the Safety Set (SS).||Subjects|||Number
755486|NCT00594386|Primary|Number of Subjects With at Least One Adverse Event During This Open-label Extension Study|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|6 years|Of the 258 subjects who entered the study, 258 are included in this summary based on the Safety Set (SS).||Subjects|||Number
755520|NCT00594425|Secondary|Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain.|Measure was assessed on a Visual Analogue Scale from 0 to 10 cm|immediately after third treatment|Safety||cm||Full Range|Median
755487|NCT00594399|Secondary|Physical Activity, Endurance|Physical activity, endurance/aerobic activities by self-report from the CHAMPS questionnaire of physical activity for older adults.|12 Months|All of the primary analyses reported here were based upon comparisons to physical activity counseling (Arm 1) versus usual care (Arm 2). No subgroup analyses within the intervention arm were conducted for this primary outcome report. The decision to analyze and report the data in Arm 1 in aggregate was done apriori during design of the study.||minutes per week||Standard Deviation|Mean
755488|NCT00594399|Secondary|Physical Activity, Endurance|Physical activity, endurance/aerobic activities by self-report from the CHAMPS questionnaire of physical activity for older adults.|3 months|||minutes per week||Standard Deviation|Mean
755489|NCT00594399|Secondary|Physical Activity, Endurance|Physical activity, endurance/aerobic activities by self-report from the CHAMPS questionnaire of physical activity for older adults.|Baseline|||minutes per week||Standard Deviation|Mean
755490|NCT00594399|Primary|12 Month Fasting Glucose||12 Months|All of the primary analyses reported here were based upon comparisons to physical activity counseling (Arm 1) versus usual care (Arm 2). No subgroup analyses within the intervention arm were conducted for this primary outcome report. The decision to analyze and report the data in Arm 1 in aggregate was done apriori during design of the study.||mg/dl||Standard Deviation|Mean
755491|NCT00594399|Primary|3 Month Fasting Glucose||3 months|||mg/dl||Standard Deviation|Mean
755492|NCT00594399|Primary|Fasting Glucose||Baseline|||mg/dl||Standard Deviation|Mean
755493|NCT00594399|Primary|12 Month Fasting Insulin||12 months|All of the primary analyses reported here were based upon comparisons to physical activity counseling (Arm 1) versus usual care (Arm 2). No subgroup analyses within the intervention arm were conducted for this primary outcome report. The decision to analyze and report the data in Arm 1 in aggregate was done apriori during design of the study.||uIU/ml||Standard Deviation|Mean
755494|NCT00594399|Primary|3 Month Fasting Insulin||3 month|||uIU/ml||Standard Deviation|Mean
755495|NCT00594399|Primary|Fasting Insulin|Fasting Insulin analyzed at VA central laboratory by technicians not affiliated with study. Participants were instructed to refrain from eating or drinking anything except water and medications past midnight. A reminder call was placed the night before the scheduled appointment and fasting was verified by study personnel before appointed blood draws.|Baseline|||uIU/ml||Standard Deviation|Mean
755496|NCT00594425|Secondary|Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment||12 weeks after last treatment|Safety||percentage of participants|||Number
755497|NCT00594425|Primary|Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline||12 weeks|PP population: excludes all patients with major protocol deviations (consists of the following types of events: Baseline inflammatory lesion count other than 20-100, received less that 4 treatments, primary efficacy criteria missing at week 12, insufficient primary efficacy follow up time, prohibited concomitant medication (retinoid).||lesions||95% Confidence Interval|Least Squares Mean
755498|NCT00594425|Primary|Proportion of Success, Defined as Improvement of at Least 2 Grades From Baseline According to the IGA Scale Based on Facial Assessment||12 weeks after last treatment|PP population: excludes all patients with major protocol deviations (consists of the following types of events: Baseline inflammatory lesion count other than 20-100, received less that 4 treatments, primary efficacy criteria missing at week 12, insufficient primary efficacy follow up time, prohibited concomitant medication (retinoid).||percentage of participants|||Number
755499|NCT00594425|Secondary|Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment||6 weeks after last treatment|Safety||percentage of participants|||Number
755500|NCT00594425|Secondary|Proportion of Patients With Mild and Moderate Hypopigmentation After First Treatment||2 weeks after first treatment|Safety||percentage of participants|||Number
755501|NCT00594425|Secondary|Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment||2 weeks after last treatment|Safety||percentage of participants|||Number
755502|NCT00594425|Secondary|Proportion of Patients With Mild and Moderate Hypopigmentation After First Treatment||2 days after first treatment|Safety||percentage of participants|||Number
755503|NCT00594425|Secondary|Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment||12 weeks after last treatment|Safety||percentage of participants|||Number
755504|NCT00594425|Secondary|Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment||6 weeks after last treatment|Safety||percentage of participants|||Number
755505|NCT00594425|Secondary|Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment||2 weeks after last treatment|Safety||percentage of participants|||Number
755506|NCT00594425|Secondary|Proportion of Patients With Mild and Moderate Hyperpigmentation After First Treatment||2 weeks after first treatment|Safety||percentage of participants|||Number
755507|NCT00594425|Secondary|Proportion of Patients With Mild and Moderate Hyperpigmentation After First Treatment||2 days after treatment|Safety||percentage of participants|||Number
755508|NCT00594425|Secondary|Proportion of Patients With Severe Erythema After Fourth Treatment||immediately after fourth treatment|Safety||percentage of participants|||Number
755509|NCT00594425|Secondary|Proportion of Patients With Severe Erythema After Third Treatment||immediately after third treatment|Safety||percentage of participants|||Number
755510|NCT00594425|Secondary|Proportion of Patients With Severe Erythema After Second Treatment||immediately after second treatment|Safety||percentage of participants|||Number
755511|NCT00594425|Secondary|Proportion of Patients With Severe Erythema 7 Days After First Treatment||7 days after first treatment|Safety||percentage of participants|||Number
755512|NCT00594425|Secondary|Proportion of Patients With Severe Erythema 2 Days After First Treatment||2 days after first treatment|Safety||percentage of participants|||Number
755513|NCT00594425|Secondary|Proportion of Patients With Severe Erythema After First Treatment||immediately after first treatment|Safety||percentage of participants|||Number
755514|NCT00594425|Secondary|Proportion of Patients With Mild and Moderate Erythema After Fourth Treatment||immediately after fourth treatment|Safety||percentage of participants|||Number
755515|NCT00594425|Secondary|Proportion of Patients With Mild and Moderate Erythema After Third Treatment||immediately after third treatment|Safety||percentage of participants|||Number
755516|NCT00594425|Secondary|Proportion of Patients With Mild and Moderate Erythema After Second Treatment||immediately after second treatment|Safety||percentage of participants|||Number
755523|NCT00594425|Secondary|The Proportion of Patients Rated as Clear or Almost Clear at 12 Weeks After Last Treatment||12 weeks after last treatment|PP population: excludes all patients with major protocol deviations (consists of the following types of events: Baseline inflammatory lesion count other than 20-100, received less that 4 treatments, primary efficacy criteria missing at week 12, insufficient primary efficacy follow up time, prohibited concomitant medication (retinoid).||percentage of participants|||Number
755524|NCT00594425|Secondary|Proportion of Success, Defined as Improvement of at Least 2 Grades From Baseline According to the IGA Scale Based on Facial Assessment||6 weeks after last treatment|PP population: excludes all patients with major protocol deviations (consists of the following types of events: Baseline inflammatory lesion count other than 20-100, received less that 4 treatments, primary efficacy criteria missing at week 12, insufficient primary efficacy follow up time, prohibited concomitant medication (retinoid).||Precentage of participants|||Number
755525|NCT00594425|Secondary|Percent Reduction in Total Lesion Counts From Baseline||6 weeks after last treatment|PP population: excludes all patients with major protocol deviations (consists of the following types of events: Baseline inflammatory lesion count other than 20-100, received less that 4 treatments, primary efficacy criteria missing at week 12, insufficient primary efficacy follow up time, prohibited concomitant medication (retinoid).||Percentage change||Full Range|Median
755526|NCT00594425|Primary|Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts||12 weeks after last treatment|ITT population||lesions||95% Confidence Interval|Least Squares Mean
755527|NCT00594425|Primary|Proportion of Success, Defined as Improvement of at Least 2 Grades From Baseline According to the IGA Scale Based on Facial Assessment||12 weeks after last treatment|ITT population||Percentage of participants||95% Confidence Interval|Number
755528|NCT00594425|Secondary|Median Percentage Change in Facial Non Inflammatory Lesion Counts From Baseline||6 weeks after last treatment|PP population: excludes all patients with major protocol deviations (consists of the following types of events: Baseline inflammatory lesion count other than 20-100, received less that 4 treatments, primary efficacy criteria missing at week 12, insufficient primary efficacy follow up time, prohibited concomitant medication (retinoid).||Percentage change||Full Range|Median
755529|NCT00594425|Secondary|Median Percentage Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline||6 weeks after last treatment|PP population: excludes all patients with major protocol deviations (consists of the following types of events: Baseline inflammatory lesion count other than 20-100, received less that 4 treatments, primary efficacy criteria missing at week 12, insufficient primary efficacy follow up time, prohibited concomitant medication (retinoid).||Percentage change||Full Range|Median
755530|NCT00594425|Secondary|Median Percentage Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline||3 weeks after last treatment|PP population: excludes all patients with major protocol deviations (consists of the following types of events: Baseline inflammatory lesion count other than 20-100, received less that 4 treatments, primary efficacy criteria missing at week 12, insufficient primary efficacy follow up time, prohibited concomitant medication (retinoid).||Percentage change||Full Range|Median
755531|NCT00594464|Primary|Efficacy and Safety of Rotigotine Used During Surgery Under General Anaesthesia Assessed by Patient.|Questionnaire including 3 items Range of sum score: 3 to 18 Range of item scores: 1 (I agree completely) to 6 (I don't agree at all) Item 1: Therapy with patch was easily feasible Item 2: Symptoms of Parkinson’s Disease were well controlled Item 3: I felt safe with the Parkinson patch|2 weeks after surgery|Full Analysis Set (Subjects having valid data for all three feasibility assessments)||Score on scale||Standard Deviation|Mean
755532|NCT00594464|Primary|Efficacy and Safety of Rotigotine Used During Surgery Under General Anaesthesia Assessed by Neurologist.|Questionnaire including 4 items Range of sum score: 4 to 24 Range of item scores: 1 (I agree completely) to 6 (I don't agree at all) Item 1: Switch to patch was easily feasible Item 2: Re-switch was easily feasible Item 3: Patient did not show unexpected symptoms Item 4: Patch is a feasible option|2 weeks after surgery|Full Analysis Set (Subjects having valid data for all three feasibility assessments)||Score on scale||Standard Deviation|Mean
755533|NCT00594464|Secondary|Plasma Concentration of Rotigotine After Use.||24 hours|Pharmacokinetic Set (Subjects for whom a blood sample for determination of the plasma concentration of rotigotine was drawn and a valid determination of the plasma concentration could be done)||ng/ml||Standard Deviation|Mean
755534|NCT00594464|Primary|Efficacy and Safety of Rotigotine Used During Surgery Under General Anaesthesia Assessed by Anaesthesiologist.|Questionnaire including 4 items Range of sum score: 4 to 24 Range of item scores: 1 (I agree completely) to 6 (I don't agree at all) Item 1: Patient did not show unexpected symptoms Item 2: Handling was simple Item 3: Handling wasn’t time-consuming Item 4: Patch is a considerable option|After subject wakes up from general anesthesia|Full Analysis Set (Subjects having valid data for all three feasibility assessments)||Score on scale||Standard Deviation|Mean
755535|NCT00585494|Secondary|Prevalence of Adverse Outcomes in the Hyperglycemic Elective Orthopedic Population.||1 year||||||
755536|NCT00585494|Secondary|Prevalence of Undiagnosed Diabetes in the Elective Orthopedic Population.||1 year||||||
755537|NCT00585494|Primary|Prevalence of Hyperglycemia in the Elective Orthopedic Population|Number of orthopedic patients that have elevated fasting blood glucose levels preoperatively|1 year|||patients|||Number
755538|NCT00585533|Secondary|Overall Survival|Estimated via a Kaplan-Meier curves. Survival will be counted from the first dose of Tarceva.|24 months|||weeks||95% Confidence Interval|Median
755539|NCT00585533|Primary|Survival Rate at 6-months Chemotherapy-progression-free (CP-free)|Will determine if 6-month chemotherapy-progression-free (CP-free) survival rate (using RECIST) is significantly higher than the historically observed 31%. A one-sided binomial test at a 5% nominal significance was used.|6 months|||percentage of participants|||Number
755540|NCT00585585|Primary|Maximum Tolerable Dose of Betahistine Dihydrochloride in mg|The highest betahistine dose that is well tolerated when patients are titrated from 50 mg to a maximum 300 mg of daily divided doses.|7 weeks|The patient did not complete the study and not enough data were collected to be analyzed.|||||
755541|NCT00585637|Secondary|Change in CRP From 0 to 3 Months.|Examine the influence of oral vitamin D supplementation on inflammatory marker CRP from baseline to the 3 month follow-up.|From baseline to 3 months|Community-based African Americans drawn from the Open Doors to Health, which is a colorectal cancer prevention study in 1554 subjects from 12 public-housing communities and community- and faith-based organizations in Boston.||mg/L||Inter-Quartile Range|Median
755542|NCT00585637|Secondary|Change in sTNF-R2 From 0 to 3 Months.|Examine the influence of oral vitamin D supplementation on inflammatory marker sTNF-R2 from baseline to the 3 month follow-up.|From baseline to 3 months|Community-based African Americans drawn from the Open Doors to Health, which is a colorectal cancer prevention study in 1554 subjects from 12 public-housing communities and community- and faith-based organizations in Boston.||pg/mL||Inter-Quartile Range|Median
755543|NCT00585637|Secondary|Change in IL-10 From 0 to 3 Months.|Examine the influence of oral vitamin D supplementation on inflammatory marker IL-10 from baseline to the 3 month follow-up.|From baseline to 3 months|Community-based African Americans drawn from the Open Doors to Health, which is a colorectal cancer prevention study in 1554 subjects from 12 public-housing communities and community- and faith-based organizations in Boston.||pg/mL||Inter-Quartile Range|Median
755544|NCT00585637|Secondary|Change in IL-6 From 0 to 3 Months.|Examine the influence of oral vitamin D supplementation on inflammatory marker IL-6 from baseline to the 3 month follow-up.|From baseline to 3 months|Community-based African Americans drawn from the Open Doors to Health, which is a colorectal cancer prevention study in 1554 subjects from 12 public-housing communities and community- and faith-based organizations in Boston.||pg/mL||Inter-Quartile Range|Median
755545|NCT00585637|Primary|Levels of Plasma 25(OH)D at Baseline, 3 Months and 6 Months.|Among Blacks, identify a dose of oral vitamin D supplementation that will result in levels of plasma 25(OH)D that would be predicted to reduce colorectal cancer incidence. Community-based African Americans drawn from the Open Doors to Health, which is a colorectal cancer prevention study in 1554 subjects from 12 public-housing communities and community- and faith-based organizations in Boston.|Baseline, 3months, 6months|Number of participants analyzed above is for baseline. At 3 months, number of participants analyzed was: 71 (no vitamin D), 67 (1000 IU Vitamin D), 76 (2000 IU Vitamin D) and 78 (4000 IU Vitamin D). At 6 months, number of participants analyzed was: 75 (no vitamin D), 68 (1000 IU Vitamin D), 72 (2000 IU Vitamin D) and 77 (4000 IU Vitamin D).||ng/mL||Inter-Quartile Range|Median
755546|NCT00585650|Primary|The Number of Subjects Who Achieve a 50% Reduction in the Palmoplantar Psoriasis Severity Index at 12 Weeks|Psoriasis area and severity index (PASI) is the most widely used tool for the measurement of severity of psoriasis. This tool is used to assess the skin lesions of the entire body however, the palmoplantar psoriasis severity index is a modified form of the the PASI that is assessed for skin lesions of the hands and feet only. The severity is estimated by three clinical signs: erythema induration and desquamation. Severity parameters are measured on a scale of 0 to 4.. The sum of all three severity parameters is then calculated based on surface area affected.|Week 12|Intention to treat||participants|||Number
755547|NCT00585689|Primary|Percentage of Patients With Complete Pathologic Response After 3 Cycles of Treatment|The rate of pathologic complete response (pT0) following three 21 day cycles of neoadjuvant ABI-007, carboplatin and gemcitabine was determined.|63 days (post 3 cycles)|29 patients were enrolled. 26 of the 29 patients received the planned 3 cycles. 22 of the 26 patients had a cystectomy and were evaluable for the primary endpoint.||percentage of patients||95% Confidence Interval|Number
755548|NCT00585715|Primary|Average Extent of Reduction in Cellulite Appearance for Patients With Reported Mild to Moderate Cellulite Reduction.|"At the 6 month follow-up, a blinded assessor ranked change in cellulite appearance on subject's thighs according to the prior cellulite dimpling and texture criteria. Change in cellulite appearance was assessed on a scale of 0-3, with 0 as no change and 3 as significant change.
Using this scale, the average reduction in cellulite appearance was calculated for each participant that experienced a mild to moderate reduction in cellulite appearance."|6 month follow up|The average amount of cellulite reduction was calculated from the 5 subjects who experienced mild to moderate improvement in cellulite appearance.||units on a scale||Standard Deviation|Mean
755549|NCT00585715|Secondary|Safety and Efficacy of Laser With and Without Cooling||Laser Treatments x3 and at 1, 3 and 6 month follow up||||||
755550|NCT00585715|Primary|Number of Participants With Mild to Moderate Reduction in Cellulite.|"Nurnberger-Muller Scale :
Stage 0: No dimpling. Stage 1: No dimpling. Stage 2: Dimpling spontaneously standing. Stage 3: Dimpling spontaneously standing and lying down.
Texture Scale:
Hard or Solid: Pinch test firm folds and furrows. Adherent to deep planes. Not modified with lying versus standing position.
Soft or Flaccid: Pinch test spongy and floating folds and furrows. No adherence to deep planes. Not painful, flaccid. Orange peel skin appears spontaneously.
Edematous: Doughy consistency. Pain and cramps. Signs of venous and lymphatic insufficiency legs in boot/column.
At the 6month follow-up, a blinded assessor ranked changes in cellulite appearance on subject's thighs according to the prior cellulite dimpling and texture criteria. Change in cellulite appearance was assessed on a scale of 0-3, with 0 as no change and 3 as significant change. Improvement in cellulite appearance was characterized by an increase of one unit or more on this scale."|6 month follow up|Only subjects who completed the 6 month follow-up were included in the analysis||participants|||Number
755551|NCT00594516|Secondary|Total Daily Dose (TDD) of Tapentadol ER During the DB Treatment Period.|Average total daily dose (TDD) of tapentadol ER during the double-blind treatment period.|14 days for each treatment period|DB safety set defined as randomized subjects who took at least one dose of study drug during the DB treatment period.||mg||Standard Deviation|Mean
755552|NCT00594516|Secondary|Total Daily Dose (TDD) of Tapentadol IR During the Double-blind Treatment Period|Average total daily dose (TDD) of tapentadol IR during the double blind treatment period|14-day for each DB treatment period|DB safety set defined as randomized subjects who took at least one dose of study drug during the DB treatment period.||mg||Standard Deviation|Mean
755553|NCT00594516|Secondary|The Number of Patients Requiring Rescue Medication During the DB Tapentadol ER Treatment||14 days for each cross-over period|DB safety set defined as randomized subjects who took at least one dose of study drug during the DB treatment period.||participants|||Number
755554|NCT00594516|Secondary|The Number of Patients Requiring Rescue Medication During the DB Tapentadol IR Treatment||14 days for each cross-over period|DB safety set defined as randomized subjects who took at least one dose of study drug during the DB treatment period.||participants|||Number
755572|NCT00594568|Secondary|LY450139 Population Pharmacokinetics: Volume of Distribution of LY450139|Model-estimated apparent volume of distribution. Volume of distribution is a measure of the extent to which the drug distributes in the body.|6 weeks, 12 weeks, and 52 weeks|The analysis population (N=974) included all participants randomized to LY450139 with sufficient drug concentration and dosing information to allow estimation of volume of distribution.||liter (L)||Geometric Coefficient of Variation|Geometric Mean
755555|NCT00594516|Primary|The Difference in the Mean Average Pain Intensity Score on an 11-point Numerical Rating Scale (NRS) During the Last 3 Days of Each Double-blind Treatment Period. (Difference Between Two DB Randomization Treatment Sequences)|"For this twice daily pain assessment, the subjects were to indicate the level of average pain experienced over the previous 12 hours on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|14 days for each cross-over period|Per-protocol set defined as the number of randomized subjects who took at least one dose of study drug during the DB treatment period, and who met additional criteria which were identified prior to unblinding.||Units on a scale||95% Confidence Interval|Least Squares Mean
755556|NCT00594568|Secondary|Change From Baseline in Phosphorylated-Tau (P-Tau) Concentration in Spinal Fluid|Concentration of p-tau in spinal fluid. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.|Baseline (randomization), up to 76 weeks|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.||picogram per milliliter (pg/mL)||Standard Error|Least Squares Mean
755557|NCT00594568|Secondary|Change From Baseline in Amyloid Beta (Aβ) 1-42 Concentration in Spinal Fluid up to 76 Weeks|Concentration of an amino peptide known as Aβ 1-42 in spinal fluid. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.|Baseline (randomization), up to 76 weeks|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.||picogram per milliliter (pg/mL)||Standard Error|Least Squares Mean
755558|NCT00594568|Secondary|Change From Baseline in Resource Utilization in Dementia-Lite (RUD-Lite) Score (Number of Hospitalizations) at 4 Weeks After Cessation of Study Drug|RUD-Lite assesses healthcare resource utilization (formal and informal care). Information gathered on both caregivers (care-giving time, work status) and participants (accommodation, healthcare resource utilization) is collected. Reported number of participant hospitalizations. Least Squares (LS) Mean value controlled for age and investigator. All LY450139 dosing was stopped due to evidence of dose-dependent cognitive/functional worsening. Participants were followed off-dose for 32 weeks, but RUD-Lite was not assessed.|Baseline (randomization), 4 weeks following treatment cessation|August 2010: all dosing was stopped after protocol-specified interim review showed dose-dependent cognitive/functional worsening of LY450139-treated participants. Participants were followed off-dose for 32 weeks. No analysis was performed at 4 weeks after cessation of drug since this outcome measure was not assessed during the follow-up period.|||||
755559|NCT00594568|Secondary|Change From Baseline in EuroQol 5-Dimensional Health-Related Quality of Life Scale Proxy Version (EQ-5D Proxy) Visual Analog Scale (VAS) Score at 4 Weeks After Cessation of Study Drug|EQ-5D (proxy version) measures mobility, self-care, usual activities, pain/discomfort, anxiety/depression. 3 severity levels: no, some, severe problems. VAS assesses caregiver's impression of participant's health state; score ranges from 0 to 100; Lower score indicates greater disease severity. LS Mean value controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication. All LY450139 dosing was stopped due to evidence of dose-dependent cognitive/functional worsening. Participants were followed off-dose for 32 weeks, but EQ-5D VAS was not assessed.|Baseline (randomization), 4 weeks following treatment cessation|August 2010: all dosing was stopped after protocol-specified interim review showed dose-dependent cognitive/functional worsening of LY450139-treated participants. Participants were followed off-dose for 32 weeks. No analysis was performed at 4 weeks after cessation of drug since this outcome measure was not assessed during the follow-up period.|||||
755560|NCT00594568|Secondary|Change From Baseline in Mini Mental State Examination (MMSE) Score at 4 Weeks After Cessation of Study Drug|MMSE is a brief screening instrument used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, copy figures) in elderly participants. Total score ranges from 0 to 30; Lower score indicates greater disease severity. LS Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication. All LY450139 dosing was stopped due to evidence of dose-dependent cognitive/functional worsening. Participants were followed off-dose for 32 weeks, but MMSE was not assessed.|Baseline (randomization), 4 weeks following treatment cessation|August 2010: all dosing was stopped after protocol-specified interim review showed dose-dependent cognitive/functional worsening of LY450139-treated participants. Participants were followed off-dose for 32 weeks. No analysis was performed at 4 weeks after cessation of drug since this outcome measure was not assessed during the follow-up period.|||||
755561|NCT00594568|Secondary|Change From Baseline in Neuropsychiatric Inventory (NPI) Score at 4 Weeks After Cessation of Study Drug|NPI assesses psychopathology in participants with dementia and other neurologic disorders. Information is obtained from a caregiver familiar with participant's behavior. Total score ranges from 12 to 144; Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication. All LY450139 dosing stopped due to evidence of dose-dependent cognitive/functional worsening. Participants were followed off-dose for 32 weeks, but NPI was not assessed|Baseline (randomization), 4 weeks following treatment cessation|August 2010: all dosing was stopped after protocol-specified interim review showed dose-dependent cognitive/functional worsening of LY450139-treated participants. Participants were followed off-dose for 32 weeks. No analysis was performed at 4 weeks after cessation of drug since this outcome measure was not assessed during the follow-up period.|||||
755562|NCT00594568|Secondary|Change From Baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Score at 4 Weeks After Cessation of Study Drug|Semi-structured interview; Participant's cognitive status rated across 6 domains of functioning: memory, orientation, judgment/problem solving, community affairs, home/hobbies, personal care. Severity score assigned for each of 6 domains. Total score (SB) ranges: 0 to 18; Higher scores=greater disease severity. LS Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication. LY450139 dosing stopped due to evidence of dose-dependent cognitive/functional worsening. Participants followed off-dose for 32 weeks, but CDR-SB not assessed.|Baseline (randomization), 4 weeks following treatment cessation|August 2010: all dosing was stopped after protocol-specified interim review showed dose-dependent cognitive/functional worsening of LY450139-treated participants. Participants were followed off-dose for 32 weeks. No analysis was performed at 4 weeks after cessation of drug since this outcome measure was not assessed during the follow-up period.|||||
755563|NCT00594568|Secondary|Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog14) Score at 16 Weeks After Cessation of Study Drug|ADAS-Cog14 is ADAS-Cog11 augmented with delayed free recall, digit cancellation, and maze completion measures. A score of 0 to 10 for delayed free recall and a conversion code of 0 to 5 for digit cancellation and maze completion provide total score ranges for this extended ADAS-Cog14 of 0 to 90. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, concomitant standard of care (SOC) medication.|Baseline (randomization), 16 weeks following treatment cessation|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.||units on a scale||Standard Error|Least Squares Mean
755564|NCT00594568|Secondary|Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog12) Score at 16 Weeks After Cessation of Study Drug|ADAS-Cog12 is ADAS‑Cog11 augmented with delayed free recall measure, resulting in a total score ranging from 0 to 80. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 16 weeks following treatment cessation|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.||units on a scale||Standard Error|Least Squares Mean
755565|NCT00594568|Secondary|Change From Baseline in Resource Utilization in Dementia-Lite (RUD-Lite) Score (Number of Hospitalizations) up to 76 Weeks|Assesses healthcare resource utilization (formal and informal care). Information gathered on both caregivers (caregiving time, work status) and participants (accommodation and healthcare resource utilization) was collected from baseline and follow-up interviews; Reported number of hospitalizations per participant up to 76 weeks. Least Squares (LS) Mean value was controlled for age and investigator.|Baseline (randomization), up to 76 weeks|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.||hospitalizations/participant||Standard Error|Least Squares Mean
755566|NCT00594568|Secondary|Change From Baseline in EuroQol 5-Dimensional Health-Related Quality of Life Scale Proxy Version (EQ-5D Proxy) Visual Analog Scale (VAS) Score at 76 Weeks|EQ-5D (proxy version) measures mobility, self-care, usual activities, pain/discomfort, anxiety/depression; each has 3 severity levels (no, some, severe problems) coded to a 1-digit number (1-3). Digits are combined into 5-digit number describing health state. Numerals 1-3 are not added for total score. VAS assesses caregiver’s impression of participant’s overall health state; scores range from 0 to 100; Lower scores indicate greater disease severity. Least Squares (LS) Mean value controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.||units on a scale||Standard Error|Least Squares Mean
755567|NCT00594568|Secondary|Change From Baseline in Neuropsychiatric Inventory (NPI) Score at 76 Weeks|NPI assesses psychopathology in participants with dementia and other neurologic disorders. Information is obtained from a caregiver familiar with the participant’s behavior. Total score ranges from 12 to 144; Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.||units on a scale||Standard Error|Least Squares Mean
755568|NCT00594568|Secondary|Change From Baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Score at 76 Weeks|CDR-SB is a semi-structured interview of participants and their caregivers. Participant’s cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; Total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.||units on a scale||Standard Error|Least Squares Mean
755569|NCT00594568|Secondary|Change From Baseline in Mini Mental State Examination (MMSE) Score at 76 Weeks|MMSE is a brief screening instrument used to assess cognitive function (orientation, memory, attention, and ability to name objects, follow verbal and written commands, write a sentence, and copy figures) in elderly participants. The total score ranges from 0 to 30; Lower score indicates greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.||units on a scale||Standard Error|Least Squares Mean
755570|NCT00594568|Secondary|Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog14) Score at 76 Weeks|ADAS-Cog14 is ADAS-Cog11 augmented with delayed free recall, digit cancellation, and maze completion measures. A score of 0 to 10 for delayed free recall and a conversion code of 0 to 5 for digit cancellation and maze completion provide total score ranges for this extended ADAS-Cog14 of 0 to 90. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.||units on a scale||Standard Error|Least Squares Mean
755571|NCT00594568|Secondary|Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog12) Score at 76 Weeks|ADAS-Cog12 is ADAS‑Cog11 augmented with delayed free recall measure, resulting in a total score ranging from 0 to 80. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.||units on a scale||Standard Error|Least Squares Mean
755573|NCT00594568|Secondary|LY450139 Population Pharmacokinetics: Clearance of LY450139|Model estimated apparent oral clearance. Clearance is defined as the volume of plasma that is completely cleared of drug (LY450139) per unit time.|6 weeks, 12 weeks, and 52 weeks|The analysis population (N=974) included all participants randomized to LY450139 with sufficient drug concentration and dosing information to allow estimation of clearance.||liter per hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
755574|NCT00594568|Secondary|Change From Baseline in Tau Concentration in Spinal Fluid up to 76 Weeks|Concentration of total tau in spinal fluid. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.|Baseline (randomization), up to 76 weeks|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.||picogram per milliliter (pg/mL)||Standard Error|Least Squares Mean
755575|NCT00594568|Secondary|Change From Baseline in Amyloid Imaging Positron Emission Tomography (AV-45 PET) up to 76 Weeks|A radioactive tracer for PET that is a ligand for amyloid called AV-45. This permits the visualization of amyloid in the brains of Alzheimer's participants. The outcome reported is the composite summary of the standard uptake value ratio (SUVR) normalized to the cerebellar gray matter. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.|Baseline (randomization), up to 76 weeks|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.||ratio||Standard Error|Least Squares Mean
755576|NCT00594568|Secondary|Change From Baseline in Hippocampal Volume Using Volumetric Magnetic Resonance Imaging (vMRI) up to 76 Weeks|The vMRI assessment of left and right hippocampal volume is reported. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.|Baseline (randomization), up to 76 weeks|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.||cubic millimeter (mm^3)||Standard Error|Least Squares Mean
755577|NCT00594568|Secondary|Change From Baseline in Positron Emission Tomography (PET) Using Fluorine-18 Fluorodeoxyglucose (18F-FDG) at 76 Weeks|Measurement of local cerebral glucose metabolism by PET using the radioactive tracer 18F-FDG. The outcome reported is the composite summary of the standard uptake value ratio (SUVR) normalized to the Pons. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.|Baseline (randomization), 76 weeks|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.||ratio||Standard Error|Least Squares Mean
755578|NCT00594568|Secondary|Percent Change From Baseline in Amyloid Beta (Aβ) 1-42 Plasma Concentration at 52 Weeks|Concentration of amino acid peptide, known as Aβ 1-42, in plasma. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.|Baseline (randomization), 52 weeks|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.||picogram per milliliter (pg/mL)||Standard Error|Least Squares Mean
755579|NCT00594568|Primary|Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Inventory Score at 16 Weeks After Cessation of Study Drug|ADCS-ADL is a 23-item inventory developed as a Rater-administered questionnaire answered by the participant’s caregiver. It measures performance of basic and instrumental activities of daily living by participants. The total score ranges from 0 to 78, with lower scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 16 weeks following treatment cessation|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.||units on a scale||Standard Error|Least Squares Mean
755580|NCT00594568|Primary|Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Inventory Score at 76 Weeks|ADCS-ADL is a 23-item inventory developed as a Rater-administered questionnaire answered by the participant’s caregiver. It measures performance of basic and instrumental activities of daily living by participants. The total score ranges from 0 to 78, with lower scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.||units on a scale||Standard Error|Least Squares Mean
755581|NCT00594568|Primary|Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) Score at 16 Weeks After Cessation of Study Drug|ADAS‑Cog11 consists of 11 items assessing areas of function most typically impaired in Alzheimer's disease (AD): orientation, verbal memory, language, and praxis. The scale ranges from 0 to 70, with higher scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 16 weeks following treatment cessation|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.||units on a scale||Standard Error|Least Squares Mean
755582|NCT00594568|Primary|Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) Score at 76 Weeks|ADAS‑Cog11 was used as a primary efficacy measure. It consists of 11 items assessing areas of function most typically impaired in Alzheimer's disease (AD): orientation, verbal memory, language, and praxis. The scale ranges from 0 to 70, with higher scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.||units on a scale||Standard Error|Least Squares Mean
755583|NCT00594646|Primary|Number of HIV-1 Infected Participants|Of participants that were evaluable at 3 months post initiation of treatment, how many became HIV-1 infected|90 days|Participants evaluable at 3 months (90 days) after treatment initiation||participants|||Number
755584|NCT00594646|Primary|Medication Regimen Completion Rates|Pill counts performed at 14 and 28 days|28 days|||participants|||Number
755604|NCT00597545|Primary|Number of Participants With Improved Neuropsychometric Changes|Battery of neuropsychometric tests to evaluate a variety of cognitive functions.|Post-operatively at 1 day|||participants|||Number
755585|NCT00594659|Primary|Point Prevalence Abstinence Post Treatment|Percent of participants that were marijuana abstinent based on urine toxicology testing at each follow up assessment across 9 month follow up period ( at the end of treatment, at 3-months, 6-months, and 9 months post the end of treatment).|9 months (from the end of treatment to 9 months post-treatment).|Intent to Treat||pecentage of participants abstinent|||Number
755586|NCT00594659|Primary|Consecutive Weeks of Marijuana Abstinence|Longest period of marijuana abstinence achieved during the 12-week treatment period documented by urine testing and self-report.|From the start of treatment through the end of the active treatment period, i.e., 12 weeks.|Intent to Treat||consecutive weeks of abstinence||Standard Deviation|Mean
755587|NCT00594685|Secondary|Relationship Between the Presence of the Factor V Leiden Mutation or the Prothrombin 20210 Mutation and the Risk of Thrombosis|Analysis not performed since central laboratory tests were not done.|Measured at Day 1 and within 35 days (+/- 7) after the diagnosis of isolated HIT|Analysis not performed since central laboratory tests were not done.|||||
755588|NCT00594685|Post-Hoc|Time to First Asymptomatic or Symptomatic Venous or Arterial Thromboembolism in the Month Following the Diagnosis of Isolated HIT|Since two versions of the data collection form were used in this study, and only the revised version contained information on whether the event was asymptomatic or symptomatic, a post-hoc analysis was performed which included all thromboses, whether symptomatic, asymptomatic, or of unknown type. Survival analysis was used.|Measured within 35 days (+/- 7) after the diagnosis of isolated HIT|||Days||Standard Error|Mean
755589|NCT00594685|Secondary|Relationship Between PF4-heparin ELISA Test, Serotonin-release Assay, and D-dimer Test Results and Thromboembolism|Analysis not performed since central laboratory tests were not done.|Measured at Day 1 and within 35 days (+/- 7) after the diagnosis of isolated HIT|Analysis not performed since central laboratory tests were not done.|||||
755590|NCT00594685|Secondary|Relationship Between the Platelet Factor 4 (PF4)-Heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) Test, the Serotonin-release Assay, and D-dimer Test Results|Analysis not performed since central laboratory tests were not done.|Measured at Day 1|Analysis not performed since central laboratory tests were not done.|||||
755591|NCT00594685|Secondary|Length of Hospital Stay (With Deaths Not Censored)|The length of time between the date of HIT diagnosis and first hospital discharge was calculated. Subjects were not censored at death. Survival analysis was used.|Measured upon hospital discharge|Two subjects were known to be readmitted to the hospital after initially being discharged.||Days||Standard Error|Mean
755592|NCT00594685|Secondary|Length of Hospital Stay|The length of time between the date of HIT diagnosis and first hospital discharge was calculated. Subjects were censored at death. Survival analysis was used.|Measured upon hospital discharge|Two subjects were known to be readmitted to the hospital after initially being discharged.||Days||Standard Error|Mean
755593|NCT00594685|Secondary|Number of Days That Medications Were Given to Participants at Participating Institutions|Per the protocol, descriptive statistics on the types and durations of therapeutic approaches used will be presented.|Measured within 35 days (+/- 7) after the diagnosis of isolated HIT|||Days medication was given||Full Range|Median
755594|NCT00594685|Secondary|Time to Platelet Count Recovery|The time to platelet recovery was defined as the time from the nadir platelet count observed in the five days after the positive HIT test was sent to observing a platelet count of 100K or greater. Survival analysis was used.|Measured within 35 days (+/- 7) after the diagnosis of isolated HIT|One subject's nadir platelet count was > 100K, so that subject is not included in the analysis.||Days||Standard Error|Mean
755595|NCT00594685|Secondary|Time Until Death From All Causes|The time until death from all causes, in days, was determined using survival analysis.|Measured within 35 days (+/- 7) after the diagnosis of isolated HIT|One subject was censored at the time that the study was terminated.||Days||Standard Error|Mean
755596|NCT00594685|Secondary|The Time to First Bleeding Event With Current Therapies for Isolated HIT|The time to first bleeding event was analyzed using survival analysis.|Measured within 35 days (+/- 7) after the diagnosis of isolated HIT|||Days||Standard Error|Mean
755597|NCT00594685|Secondary|The Number of Participants With Incidental Arterial and Venous Thromboembolism (i.e., a Clot Diagnosed by Radiographic Tests Done for Reasons Other Than to Diagnose or Rule Out a Thromboembolic Event)|There were two versions of the data collection form used in this study, and only the revised form contained information on whether the event was incidental.|Measured within 35 days (+/- 7) after the diagnosis of isolated HIT|Two subjects did not have information on whether the event was incidental. These subjects were censored in the analysis.||Participants|||Number
755598|NCT00594685|Secondary|The Number of Participants With Symptomatic Venous or Arterial Thromboembolism in the Month Following the Diagnosis of Isolated HIT|There were two versions of the data collection form used in this study, and only the revised version collected information on whether the event was symptomatic.|Measured within 35 days (+/- 7) after the diagnosis of isolated HIT|Two subjects did not have information on whether the event was symptomatic or asymptomatic. These two subjects were censored in the analysis.||Participants|||Number
755599|NCT00594685|Secondary|The Percentage of Participants With Asymptomatic Thrombosis 4 Weeks After the Diagnosis of Isolated HIT, Determined by Four-limb Ultrasound|The percentage of participants with asymptomatic thrombosis 4 weeks after the diagnosis of isolated HIT, determined by four-limb ultrasound, and 95% exact binomial confidence interval.|Measured at Day 35 (+/- 7days)|Four subjects had missing data for this endpoint (no ultrasound performed on end-of-study date) and are not included in this analysis.||Percentage of participants||95% Confidence Interval|Mean
755600|NCT00594685|Primary|The Percentage of Participants With Asymptomatic Thrombosis at the Time Isolated Heparin-Induced Thrombocytopenia (HIT) is Diagnosed, Determined by Four-limb Ultrasound|The percentage of participants with asymptomatic thrombosis at the time isolated HIT is diagnosed as determined by four-limb ultrasound.|Measured at Day 1|||Percentage of participants||95% Confidence Interval|Mean
755601|NCT00594815|Primary|Progression Free Survival|Overall Progression Free Survival at 2 years|2 Years|||percentage of participants||95% Confidence Interval|Number
755602|NCT00594815|Primary|Total Number of Participants Who Experienced Acute Treatment Related Adverse Events|The toxicity of this combined regimen will be measured using the NCI CTC version 2.0.|2 years|||Participants|||Count of Participants
755603|NCT00597519|Primary|Overall Response|To obtain a preliminary estimate of efficacy of double unit UCBT as measured by overall response.|1 year|||participants|||Number
755607|NCT00597558|Primary|Double-blind, Placebo-controlled Food Challenge (DBPCFC) to Egg|Subjects will have a double-blind, placebo-controlled food challenge (DBPCFC) to egg after at least 24 months of egg OIT when the IgE to egg is < 7 kU/L or 90% of entry level IgE or SPT <= 5mm with a maximum treatment period of 60 months.|24-60 months|||subjects with no symptoms on DBPCFC|||Number
755608|NCT00597584|Secondary|Proportion of Participants Whose Mean Hemoglobin Level During the Evaluation Period is Within the Target Range of 10.0 - 12.0 Grams Per Deciliter (g/dL)||Weeks 29 to 36|Full Analysis Population: All randomized participants who received at least one dose of study medication||percentage of participants|||Number
755609|NCT00597584|Secondary|Proportion of Participants Who Receive Red Blood Cell (RBC) Transfusions During the Titration and Evaluation Periods||Weeks 0 to 36|Full Analysis Population: All randomized participants who received at least one dose of study medication||percentage of participants|||Number
755610|NCT00597584|Primary|Mean Change in Hemoglobin Between Baseline and the Evaluation Period|The baseline hemoglobin value is defined as the mean of five hemoglobin values: the four most recent hemoglobin values taken prior to the day of randomization and the value obtained on the day of randomization. The mean hemoglobin during the Evaluation Period for each participant is calculated as the mean of the available hemoglobin values during study Weeks 29 through 36.|Baseline to Weeks 29-36|Full Analysis Population: All randomized participants who received at least one dose of study medication||g/dL||Standard Deviation|Mean
755611|NCT00597675|Secondary|The Change From Baseline Through the End of Peanut OIT Treatment in Peanut-specific IgG4 in the Blood.|Peanut specific IgG4 is thought to have a protective effect for a subject when exposed to peanut possibly by interfering with IgE. Peanut-specific IgG4 is measured from serum in the blood by an immunoCAP machine and reported in mg/dL. A higher level of peanut-specific IgG4 could suggest a decrease in the probability of reaction for a subject who is exposed to peanut.|Baseline to end of open label phase treatment (36-60 months)|||mg/dL||Full Range|Median
755612|NCT00597675|Secondary|The Change From Baseline Through the End of Peanut OIT Treatment in Peanut-specific IgE in the Blood|Peanut specific IgE on the surface of mast cells and basophils releases histamine when exposed to peanut causing symptoms of allergy. Free-floating peanut-specific IgE is measured from serum in the blood by an immunoCAP machine and reported in kU/L. A lower level of peanut-specific IgE could suggest a decrease in the probability of reaction for a subject who is exposed to peanut.|Baseline to end of open label phase treatment (36-60 months)|||kU/L||Full Range|Median
755613|NCT00597675|Secondary|The Change From Baseline Through the End of Peanut OIT Treatment in Wheal Size Diameter Following Peanut Skin Prick Testing|Skin prick testing is performed by scratching the skin with a small amount of peanut and observing for redness and a raised bump called a wheal. The diameter of the wheal is measured with a ruler in mm and recorded as a measure of peanut-specific IgE and mast cell reactivity in an allergic subject. A decrease in wheal size after treatment would represent suppression of the allergic response.|Baseline to end of open label phase treatment (36-60 months)|||mm||Full Range|Median
755614|NCT00597675|Secondary|The Amount of Peanut Protein Ingested Before An Allergic Reaction is Observed During the Double-blind, Placebo Controlled Food Challenge (DBPCFC) After Completing 12 Months of Blinded Peanut OIT or Placebo Treatment.|After 12 months of blinded Peanut OIT treatment, the reaction threshold for subjects is assessed by a DBPCFC. This involves eating small increasing doses of peanut protein in a blinded fashion up to a cumulative total of 4710 mg. An identical food challenge is also performed with oat flour as a placebo. The cumulative amount of peanut protein ingested prior to the dose that causes a reaction requiring treatment is reported as the reaction threshold.|12 months|||mg of peanut protein||Full Range|Median
755615|NCT00597675|Primary|The Amount of Peanut Protein Ingested Before An Allergic Reaction is Observed During the Double-blind, Placebo Controlled Food Challenge (DBPCFC) After Completing Treatment With Peanut OIT.|After completing the peanut OIT protocol (defined as treatment with peanut OIT for at least 36-months AND a peanut-specific IgE >2 and <15 AND skin prick test is <5 mm OR a maximum of 60 months of treatment), the reaction threshold for subjects is assessed by a DBPCFC. This involves eating small increasing doses of peanut protein in a blinded fashion up to a cumulative total of 5000 mg. An identical food challenge is also performed with oat flour as a placebo. The cumulative amount of peanut protein ingested prior to the dose that causes a reaction requiring treatment is reported as the reaction threshold.|36-60 months|||mg of peanut protein||Full Range|Median
755616|NCT00597701|Primary|Benzodiazepine Doses Used to Treat Acutely-withdrawing Alcoholic Patients in the Baclofen-treated and Placebo-treated Groups|In acutely-withdrawing alcoholic patients treated with either baclofen or placebo, symptom-driven benzodiazepine doses were assessed for the 72 hours following the first Clinical Institute Withdrawal Assessment (CIWA) score of 11 or greater.|From eligibility for randomization (Clinical Institute Withdrawal Assessment [CIWA] score of at least 11) until 72 hours of observation had been completed.|||mg of benzodiazepine per 8 hours||Standard Deviation|Mean
755617|NCT00597714|Secondary|Graft Failure|Estimate toxicity including graft-versus-host disease (GVHD) in participants treated with an alemtuzumab T cell depleted, reduced intensity preparative regimen followed by allogeneic hematopoietic transplantation. Bone marrow aspiration and/or biopsy were performed 3–5 weeks after transplant to assess donor-cell engraftment. Primary Graft Failure was defined as a neutrophil count below 500/μL or the absence of donor-derived hematopoiesis (<5%donor cells) before relapse, death, or re-transplantation. Secondary Graft Failure was defined as the achievement of primary engraftment and a subsequent decrease in neutrophils to 3 consecutive counts of less than 100/μL or the absence of donor-derived hematopoiesis (<5% donor cells) before relapse, death, or re-transplantation.|180 days|All subjects who received transplant. Cohort A (n=62) had acute or chronic leukemia (ALL or CLL), lymphoma, or myeloma. Cohort B (n=62) had acute or chronic myeloid leukemia (AML or CML), myelodysplastic disorder or myeloproliferative disorder. Analysis by occurrence of Graft versus Host Disease (GvHD) and donor type.||number of participants|||Number
755654|NCT00598442|Primary|Mean Change in Hemoglobin Between Baseline and the Evaluation Period|The baseline hemoglobin value is defined as the mean of three hemoglobin values: the two most recent hemoglobin values taken prior to the day of randomization and the value obtained on the day of randomization. The mean hemoglobin during the Evaluation Period for each participant is calculated as the mean of the available hemoglobin values during Study Weeks 25 through 36.|Baseline and Weeks 25-36|Full Analysis Population: All randomized participants who received at least one dose of study medication||g/dL||Standard Deviation|Mean
755618|NCT00597714|Other Pre-specified|Graft Versus Host Disease|Estimate toxicity including graft-versus-host disease (GVHD) in participants treated with an alemtuzumab T cell depleted, reduced intensity preparative regimen followed by allogeneic hematopoietic transplantation. Bone marrow aspiration and/or biopsy were performed 3–5 weeks after transplant to assess donor-cell engraftment. Acute or chronic GVHD was diagnosed and graded according to standard criteria. Toxicity was formally graded using the National Cancer Institute Common Toxicity Criteria version 3.0.|180 days|All participants who received transplant. Cohort A (n=62) had acute or chronic leukemia (ALL or CLL), lymphoma, or myeloma. Cohort B (n=62) had acute or chronic myeloid leukemia (AML or CML), myelodysplastic disorder or myeloproliferative disorder. Analysis by occurrence of Graft versus Host Disease (GvHD) and Graft Failure and donor type.||percentage of participants||95% Confidence Interval|Number
755619|NCT00597714|Secondary|Overall Survival|Estimate overall survival rates in participants treated with an alemtuzumab T cell depleted, reduced intensity preparative regimen followed by allogeneic hematopoietic transplantation. Disease-free survival (DFS), progression-free survival (PFS), and overall survival (OS) rates after SCT were estimated using the Kaplan-Meier method. We performed univariate comparisons by using the log-rank test. OS was defined as the period of time between the day of transplantation and death. The following variables were considered as confounders: recipient age, recipient sex, disease (myeloid or lymphoid), disease risk (standard or high), and donor type (MRD, MUD, or HAPLO donor). The percentage of participants surviving 2 years by donor type is reported.|2 years|All participants who received transplant. Cohort A (n=62) had acute or chronic leukemia (ALL or CLL), lymphoma, or myeloma. Cohort B (n=62) had acute or chronic myeloid leukemia (AML or CML), myelodysplastic disorder or myeloproliferative disorder. Analysis by type of donor (Matched Unrelated Donor; Matched Related Donor; Haplo-identical).||percentage of participants||95% Confidence Interval|Number
755620|NCT00597714|Secondary|Progression Free Survival|Progression-free survival (PFS) rates after stem cell transplant were estimated using the Kaplan-Meier method. We performed univariate comparisons by using the log-rank test. PFS was defined as the period of time between the day of transplantation and either the day underlying disease progression was documented or death occurred by any cause. The following variables were considered as confounders: recipient age, recipient sex, disease (myeloid or lymphoid), disease risk (standard or high), and donor type (MRD, MUD, or HAPLO donor). The percentage of participants progression free at 2 years is reported by donor type. Progression = > 25% increase of serum M-protein and/or urine M-protein. Also, an absolute increase in bone marrow plasma cells > 10%, new bone lesions or soft tissue plasmacytomas or increase in the size of existing bone lesions or soft tissue plasmacytomas or development of hypercalcemia that can be attributed solely to the plasma cell proliferative disorder.|2 years|All participants who received transplant. Cohort A (n=62) had acute or chronic leukemia (ALL or CLL), lymphoma, or myeloma. Cohort B (n=62) had acute or chronic myeloid leukemia (AML or CML), myelodysplastic disorder or myeloproliferative disorder. Analysis by type of donor (Matched Unrelated Donor; Matched Related Donor; Haplo-identical).||percentage of participants||95% Confidence Interval|Number
755621|NCT00597714|Secondary|Immune Recovery|Evaluate immune recovery following this reduced intensity allogeneic immunotherapy. Quantification of CD3+, CD4+, and CD8+ T cells was performed by flow cytometry on fresh peripheral blood at approximately 1 month before transplantation and then 1.5, 3, 6, and 12 months after transplantation. The immune recovery rates of the CD3+, CD4+, and CD8+ T cells in the MRD, MUD, and HAPLO groups were compared by performing an analysis of variance at each time point after transplantation. The median T cell counts at 12 months for each type of cell are reported by donor type.|1 year|All subjects with complete response. Cohort A (n=62) had acute or chronic leukemia (ALL or CLL), lymphoma, or myeloma. Cohort B (n=62) had acute or chronic myeloid leukemia (AML or CML), myelodysplastic disorder or myeloproliferative disorder. Analysis by type of donor (Matched Unrelated Donor; Matched Related Donor; Haplo-identical).||T cells/μL||Standard Deviation|Mean
755622|NCT00597714|Primary|Disease Free Survival|Estimate disease free survival rates in participants treated with an alemtuzumab T cell depleted, reduced intensity preparative regimen followed by allogeneic hematopoietic transplantation. Disease-free survival (DFS), progression-free survival (PFS), and overall survival (OS) rates after SCT were estimated using the Kaplan-Meier method. We performed univariate comparisons by using the log-rank test. DFS was defined as the period of time between the day of transplantation and either disease relapse or death due to the disease. The following variables were considered as confounders: recipient age, recipient sex, disease (myeloid or lymphoid), disease risk (standard or high), and donor type (MRD, MUD, or HAPLO donor). The percentage of participants who were disease free at 2 years is reported by donor type.|2 years|All subjects with complete response. Cohort A (n=62) had acute or chronic leukemia (ALL or CLL), lymphoma, or myeloma. Cohort B (n=62) had acute or chronic myeloid leukemia (AML or CML), myelodysplastic disorder or myeloproliferative disorder. DFS was analyzed by type of donor (Matched Unrelated Donor; Matched Related Donor; Haplo-identical).||percentage of participants||95% Confidence Interval|Number
755623|NCT00597727|Secondary|Percentage of Subjects Tolerating a Peanut Oral Food Challenge 2-4 Weeks After Discontining Peanut SLIT Dosing|Upon completion of 36-60 months of peanut SLIT treatment, subjects underwent a double-blind placebo controlled food challenge (DBPCFC) to assess desensitization (an increase in reaction threshold while on therapy). A DBPCFC involves the ingestion of small increasing amounts of peanut up to a cumulative total amount. Peanut SLIT therapy was then discontinued for 2-4 weeks to assess for persistence of the desensitization response called sustained unresponsiveness (SU). The secondary clinical efficacy outcome of the study was the percentage of peanut allergic subjects who completed a 5000 mg peanut protein DBPCFC without developing symptoms 2-4 weeks after discontinuing peanut SLIT therapy.|36-60 months|Although the 12 month OFC was discontinued beginning in 7/2010, all subjects reaching the end of study (36-60 months of treatment) underwent an OFC resulting in more patients performing the end of study OFC than the 12 month OFC.||percentage of participants|||Number
755655|NCT00598507|Secondary|Occurrence of Attributable Serious Adverse Events (SAEs)|Number of participants with Grade 3 or higher adverse events, attributable to treatment with sagopilone.|Up to 5 years|All participants||participants|||Number
755656|NCT00598507|Secondary|Median Overall Survival (OS)|Median OS: the time (expressed in months or years) when half the patients are expected to be alive.|Up to 5 years|All participants||weeks||95% Confidence Interval|Median
756040|NCT00591344|Secondary|Cognitive Function - Digit Span Forward/Backward|This tests a persons ability to remember that were read to them both forward and then backwards.|obtained during initial evaluation & then every 6 six months to end of 2-yr training period||||||
755624|NCT00597727|Primary|Percentage of Subjects Who Can Tolerate the Peanut Oral Food Challenge After 12 Months of Peanut SLIT Dosing|Upon completion of 12 months of peanut SLIT treatment, subjects underwent a double-blind placebo controlled food challenge (DBPCFC) to assess desensitization (an increase in reaction threshold while on therapy). A DBPCFC involves the ingestion of small increasing amounts of peanut up to a cumulative total amount. The primary clinical efficacy outcome of the study was the percentage of peanut allergic subjects who completed a 2500 mg peanut protein DBPCFC without developing symptoms after 12 months of peanut SLIT therapy.|12 months|Interim analysis in 7/2010 showed statistically significant difference in peanut tolerated during oral food challenge (OFC) by active treatment vs placebo (1710mg vs 85mg). Further OFCs for those on placebo was considered more risk than benefit thus were discontinued resulting in subsequent patients being unblinded after 12 months without an OFC||percentage of participants|||Number
755625|NCT00597753|Secondary|Proportion of Participants Whose Mean Hemoglobin Level During the Evaluation Period is Within the Target Range of 10.0 - 12.0 Grams Per Deciliter (g/dL)||Weeks 29 to 36|Full Analysis Population: All randomized participants who received at least one dose of study medication||percentage of participants|||Number
755626|NCT00597753|Secondary|Proportion of Participants Who Receive Red Blood Cell (RBC) Transfusions During the Titration and Evaluation Periods||Weeks 0 to 36|Full Analysis Population: All randomized participants who received at least one dose of study medication||percentage of participants|||Number
755627|NCT00597753|Primary|Mean Change in Hemoglobin Between Baseline and the Evaluation Period|The baseline hemoglobin value is defined as the mean of five hemoglobin values: the four most recent hemoglobin values taken prior to the day of randomization and the value obtained on the day of randomization. The mean hemoglobin during the Evaluation Period for each participant is calculated as the mean of the available hemoglobin values during study Weeks 29 through 36.|Baseline and Weeks 29-36|Full Analysis Population: All randomized participants who received at least one dose of study medication||g/dL||Standard Deviation|Mean
755628|NCT00597896|Primary|Change From Baseline to Week 8 in Controlled Oral Word Association Test (COWAT) Letter Fluency|The examinee is required to say as many words as they can think of in one minute that begin with a given letter of the alphabet. The task contains three trials. Measures phonetic verbal fluency. The raw score (total words recorded across the three trials) was reported. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8.|Change from Baseline to Week 8|All randomized participants were assessed per protocol||words||Standard Deviation|Mean
755629|NCT00597896|Primary|Change From Baseline to Week 8 in Hopkins Verbal Learning Test|The examinee is required to recall a list of 12 words over 3 immediate learning trials, a delayed recall trial and a recognition trial. Measures learning and retention of verbal material. The total number of words recalled during the delayed recall trial was reported. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8.|Change from Baseline to Week 8|All randomized participants were assessed per protocol||words||Standard Deviation|Mean
755630|NCT00597896|Primary|Change From Baseline to Week 8 in d2 Test of Attention|"The d2 Test of Attention consist of 14 lines, each comprised of 47 characters, for a total of 658 items. The examinee must scan each line and cross out all the d's with two dashes. The subject is allowed 20 seconds per line. Measures rapid processing of visual information and motor speed."|Change from Baseline to Week 8|All randomized participants were assessed per protocol||units on a scale||Standard Deviation|Mean
755631|NCT00597896|Primary|Change From Baseline to Week 8 in Trail Making Test Part B|The examinee is instructed to connect a set of 25 dots, alternating between numbers and letters, as quickly as possible while maintaining accuracy. Measures attentional resources and is a measure of the frontal lobe “executive” functions of visual search, set-switching and conceptual flexibility. The total time in seconds was reported for this measure. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8.|Change from Baseline to Week 8|All randomized participants were assessed per protocol||seconds||Standard Deviation|Mean
755632|NCT00597896|Primary|Change From Baseline to Week 8 in Trail Making Test Part A|The examinee is instructed to connect a set of 25 dots as quickly as possible while maintaining accuracy. Measures attentional resources and is a measure of the frontal lobe “executive” functions of visual search, set-switching and conceptual flexibility. The total time in seconds was reported for this measure. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8.|Change from Baseline to Week 8|All randomized participants were assessed per protocol||seconds||Standard Deviation|Mean
755633|NCT00597896|Primary|Change From Baseline to Week 8 in Stroop Color-Word Test|The Stroop Color-Word Test consists of a word page with words printed in black ink, a color page with ‘Xs’ printed in color, and a color-word page where the color and the word do not match. The examinee reads the words or names the ink colors as quickly as possible within a time limit. Measures selective attention and inhibitory control. The raw scores (total number of words read) for each trial were reported for this measure. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8.|Change from Baseline to Week 8|All randomized participants were assessed per protocol||words||Standard Deviation|Mean
755634|NCT00597896|Primary|Change From Baseline to Week 8 in Weschler Adult Intelligence Scale-Third Edition (WAIS-III) Digit Symbol Coding Test|Using a key, the examinee copies symbols that are paired with numbers within a specified time limit. Measures visual scanning and graphomotor speed. The standard scores were reported for this measure. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8.|Change from Baseline to Week 8|All randomized participants were assessed per protocol||units on a scale||Standard Deviation|Mean
755635|NCT00597896|Primary|Change From Baseline to Week 8 in Weschler Adult Intelligence Scale-Third Edition (WAIS-III) Digit Span Subtest (Digits Backward)|The examinee is read a sequence of numbers and must recall the numbers in reverse order. Measures auditory attention and verbal working memory. The standard scores were reported for this measure. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8.|Change from Baseline to Week 8|All randomized participants were assessed per protocol||number of correct numbers recalled||Standard Deviation|Mean
755636|NCT00597896|Secondary|Double-blind: Change From Baseline in Clinician-Administered Rating Scale for Mania (CARS-M)Total Score at Endpoint|The CARS-M is a 15-item clinician-rated scale designed to assess severity of both manic and psychotic symptoms. There are 2 subscales: a mania scale and a scale for psychotic symptoms and disorganization. There are a total of 15 items on the CARS-M, each of which is rated on a 6-point Likert scale (0/Absent to 5/Extreme), with the exception of item 15 (“Insight”) which is rated on a 5-point Likert scale. These items yield two subscale scores—one for Mania (items 1-10) and one for Psychosis (items 11-15). Higher scores indicate worsening. The responses are summed to yield the CARS-M-15 score that ranges from 0-74.|Change from Baseline to Week 8|All randomized participants were assessed per protocol||units on a scale||Standard Deviation|Mean
755637|NCT00597896|Secondary|Double-blind: Change From Baseline in Hamilton Rating Scale for Depression (HAM-D-21) Total Score at Endpoint|The Hamilton Depression Rating Scale is a clinician-rated scale used to rate depression severity. The items are rated on either a 5-point (0 to 4) or a 3-point (0 to 2) scale. The 5-point scale uses a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). Higher scores indicate worsening. The responses are summed to yield the HAM-D-21 score that ranges from 0-64.|Change from Baseline to Week 8|All randomized participants were assessed per protocol||units on a scale||Standard Deviation|Mean
755638|NCT00597896|Primary|Change From Baseline to Week 8 in Weschler Adult Intelligence Scale-Third Edition (WAIS-III) Digit Span Subtest (Digits Forward)|The examinee is read a sequence of numbers and must recall the numbers in the same order. Measures auditory attention and verbal working memory. The standard scores were reported for this measure. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8.|Change from Baseline to Week 8|All randomized participants were assessed per protocol||number of correct numbers recalled||Standard Deviation|Mean
755639|NCT00597909|Secondary|Pharmacokinetic Characteristics of Ammonul® and Its Metabolites||Every 24 hours during treatment period of 96 hours||||||
755640|NCT00597909|Secondary|Effects of Ammonul® on Blood Ammonia Levels, Amino Acids and Carnitine||96 hours of treatment and follow-up||||||
755641|NCT00597909|Secondary|Efficacy, as Assessed by Severity of Hepatic Encephalopathy Using the Glasgow Coma Scale||96 hours of treatment and follow-up||||||
755642|NCT00597909|Secondary|Efficacy, as Assessed by Percentage of Subjects With a 1 or 2 Grade Improvement, Using the West Haven Criteria||participants will be followed for the duration of hospital stay, an expected average of 96 hours||||||
755643|NCT00597909|Secondary|Efficacy, as Assessed by Time Spent in an Improved State by 1 or 2 Grades Using the West Haven Criteria||96 hours of treatment and follow-up||||||
755644|NCT00597909|Secondary|Efficacy, as Assessed by Proportion of Assessments With 1-grade Improvement, Using West Haven Criteria||96 hours of treatment and follow-up||||||
755645|NCT00597909|Secondary|Efficacy, as Assessed by Proportion of Assessments With a 2-grade Improvement, Using West Haven Criteria||96 hours of treatment and follow-up||||||
755646|NCT00597909|Secondary|Safety, as Assessed by Reported Adverse Events, Clinical Laboratory Measurements, Changes in Vital Signs, and Changes in 12-lead ECG Results||96 hours of treatment and follow-up||||||
755647|NCT00597909|Primary|Efficacy, as Assessed by Time to Grade 2 or Less in the West Haven Criteria Sustaining for 4 Hours or Longer||Time to Grade 2 or less sustaining for 4 hours or longer|One participant enrolled but did not receive drug or was randomized.|||||
755648|NCT00598078|Primary|Modified FTM(Fahn-Tolosa-Marin) Essentials Tremor Rating Scale, Sum of All Essential Rating Tremor Scales Including Voice Tremor|The modified FTM sum of all essential rating tremor scales including voice tremor includes: the tremor rating taken for the left & right hands individually at rest, with posture (arms outstretched), with action (finger to nose). It also includes an evaluation of voice with scores for AAA & EEE sounds, an action evaluation of left & right hands pouring, bringing liquids to mouth, drawing large & small spirals. Scores for indiviuals items range from 0 (no tremor) to 4 (severe tremor). The sum ranges from 0 (no tremor) to 72 points (higher amplitude/more tremors).|Hour 1|||Points||90% Confidence Interval|Least Squares Mean
755649|NCT00598273|Secondary|Proportion of Participants Achieving Hemoglobin Response During the Correction and Evaluation Periods.|A hemoglobin response is defined as hemoglobin increase of ≥ 1.0 gram per deciliter (g/dL) above baseline and a hemoglobin ≥ 11.0 g/dL without RBC transfusion during the previous 8 weeks.|Weeks 0 to 36|Full Analysis Population: All randomized participants who received at least one dose of study medication||percentage of participants|||Number
755650|NCT00598273|Secondary|Proportion of Participants Who Receive Red Blood Cell (RBC) Transfusions During the Correction and Evaluation Periods||Weeks 0 to 36|Full Analysis Population: All randomized participants who received at least one dose of study medication||percentage of participants|||Number
755651|NCT00598273|Primary|Mean Change in Hemoglobin Between Baseline and the Evaluation Period|The baseline hemoglobin value is defined as the mean of three hemoglobin values: the two most recent hemoglobin values taken prior to the day of randomization and the value obtained on the day of randomization. The mean hemoglobin during the Evaluation Period for each participant is calculated as the mean of the available hemoglobin values during Study Weeks 25 through 36.|Baseline and Weeks 25-36|Full Analysis Population: All randomized participants who received at least one dose of study medication||g/dL||Standard Deviation|Mean
755652|NCT00598442|Secondary|Proportion of Participants Achieving Hemoglobin Response During the Correction and Evaluation Periods|A hemoglobin response is defined as a hemoglobin increase of ≥ 1.0 gram per deciliter (g/dL) above baseline and a hemoglobin ≥ 11.0 g/dL without RBC transfusion during the previous 8 weeks.|Weeks 0 to 36|Full Analysis Population: All randomized participants who received at least one dose of study medication||percentage of participants|||Number
755653|NCT00598442|Secondary|Proportion of Participants Who Received Red Blood Cell (RBC) Transfusions During the Correction and Evaluation Periods||Weeks 0 to 36|Full Analysis Population: All randomized participants who received at least one dose of study medication||percentage of participants|||Number
755657|NCT00598507|Secondary|Median Progression Free Survival (PFS)|PFS: the duration of time from start of treatment to time of progression or death, whichever occurs first. Progressive Disease (PD)according to modified Response Evaluation Criteria in Solid Tumors (RECIST) Criteria: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).|Up to 5 years|All participants||weeks||95% Confidence Interval|Median
755658|NCT00598507|Primary|Response Rate (RR)|Objective tumor response according to Response Evaluation Criteria In Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Stable disease is measured from the start of the treatment until the criteria for progression are met, taking as reference the smallest measurements recorded since the treatment started, including the baseline measurements. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).|Up to 5 years|All participants||participants|||Number
755659|NCT00598559|Secondary|Subject Global Evaluation of the Level of Satisfaction With Study Treatments Looking Back Over the Entire Treatment Period.|Using a four point categorical scale 0= poor, 1= fair, 2= good, 3= excellent, comparisons of subject's Global Evaluations of the level of satisfaction with study treatments looking back over the entire treatment period was conducted at Day 7.|Study period lookback at Day 7|Analyses were conducted using the mITT population, defined as subjects who were randomized to the IV acetaminophen groups and who received at least one dose of IV acetaminophen, and all subjects assigned to the SOC group.||Units on a scale||Standard Deviation|Mean
755660|NCT00598559|Primary|Subjects Who Experienced at Least One Serious Treatment-Emergent Adverse Event (TEAE)|"Serious TEAE is any untoward medical occurrences at any dose of study medication that:
results in death
is life threatening
requires inpatient hospitalization or causes prolongation of existing hospitalization
results in persistent or significant disability/incapacity
is a congenital anomaly/birth defect
is an important medical event"|First dose (T0) to within 30 days of the last dose of study medication.|Safety analyses were conducted using the mITT population, defined as subjects who were randomized to the IV acetaminophen groups and who received at least one dose of IV acetaminophen, and all subjects assigned to the SOC group.||Participants|||Number
755661|NCT00598559|Primary|Number of Subjects Reporting at Least One Treatment-Emergent Adverse Event (TEAE).|"Number of subjects who experienced at least one treatment emergent adverse event (TEAE).
A TEAE is an adverse event that occurs on or after the first dose of study medication (T0)."|T0 (first dose of IV APAP or randomization to SOC group) to Day 7 - 12 Follow-up|Safety analyses were conducted using the mITT population, defined as subjects who were randomized to the IV acetaminophen groups and who received at least one dose of IV acetaminophen, and all subjects assigned to the SOC group.||Participants|||Number
755662|NCT00598559|Secondary|Subject Global Evaluation of the Level of Satisfaction With Side Effects Related to Study Treatments|Using a four point categorical scale 0= poor, 1= fair, 2= good, 3= excellent, comparisons of subject's Global Evaluations of the level of satisfaction with side effects related to study treatment at End of Day 5 (prior to discharge)|End of Day 5 (prior to discharge)|Analyses were conducted using the mITT population, defined as subjects who were randomized to the IV acetaminophen groups and who received at least one dose of IV acetaminophen, and all subjects assigned to the SOC group.||Units on a scale||Standard Deviation|Mean
755663|NCT00598585|Primary|Change in Fatigue Impact Scale at 6 Weeks|change in fatigue impact scale there are 42 questions. Each question can be answered from 0 (no problem) to 4 (extreme problem), so a higher score indicates more severe fatigue impact. minimum score=0, maximum score =148 values are calculated at baseline and 6 months and the score at 6 months compared to baseline months is calculated|6 weeks|||units on a scale||Standard Deviation|Mean
755664|NCT00598650|Primary|Change From Baseline in Neuropsychiatric Inventory (NPI) Score of Psychiatric Symptoms|"NPI measured 10 different domains of psychiatric symptoms including delusion and hallucination. Each domain is scored for: present or absent, frequency, and severity. The score derived from sub-scores; total ranged from 0 to 120, higher score indicated worse neuropsychiatric outcomes."|Baseline, Week 52, and Week 52 LOCF|Efficacy Analysis Set||Score on a Scale||Standard Deviation|Mean
755665|NCT00598650|Primary|Change From Baseline in Mini-mental State Examination (MMSE) Total|MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranged from 0 - 30, where a higher score indicated better cognitive state.|Baseline, Week 52, and Week 52 LOCF|Efficacy Analysis Set: subjects who received at least one dose of E2020 and also provided safety assessment data after baseline, with at least one available efficacy evaluation. Two subjects whose diagnosis was suspected not to meet clinical criteria of probable DLB and 2 subjects with lack of efficacy data were excluded from the efficacy analysis.||Score on a Scale||Standard Deviation|Mean
755666|NCT00598689|Secondary|Tolerability and Alleviation of Post-operative Pain in LASIK Surgery|A comparison of subjective comfort level defined as tolerability and alleviation of post-operative pain experienced as a result of post-operative application of GenTeal drops. Subjective pain level was measured on a 10 point likert scale where 0 = no pain and 10 = worst pain possible. A lower score at Week 1 as compared to Day 1 was considered improved. A same score or higher at week 1 as compared to day 1 was considered no improvement.|Week 1 post surgery|Subjects randomized to either group and completed LASIK surgery.||percentage of subjects|||Number
755667|NCT00598689|Secondary|Post Operative Pain Level|Assess whether preoperative GenTeal Gel alleviates post operative pain in LASIK surgery patients compared to control (no preoperative lubricant) as measured by patient completion of the Universal Pain Assessment Tool (moderate), a ten point scale with 0 being no pain and 10 being the worst pain possible. Data on the level of pain only in the right eye will be collected.|Day 1, End of Week 1|Subjects that completed LASIK surgery.||units on a scale||Standard Deviation|Mean
755668|NCT00598689|Primary|Epithelial Healing After Laser Assisted in Situ Keratomileusis (LASIK) Surgery|Assess whether preoperative GenTeal Gel enhances epithelial healing after LASIK surgery within the first post-operative week, compared to control (no preoperative lubricant). Healing of the area of the cornea covering the radius of the sectioned into clock hours 0 - 12 where 0 hours equals no healing and 12 hours equals complete healing.|Day 1, End of Week 1|Subjects that completed LASIK surgery.||Clock Hours||Standard Deviation|Mean
755702|NCT00599131|Secondary|The Change in Overall Quality of Life Score During Radiation Therapy and at 6, 12, and 24 Months Post Treatment.|To evaluate the quality of life (QOL).|24 months|The study was discontinued prematurely due to an early stopping rule. No participants were assessed because an insufficient number of patients were recruited.|||||
755669|NCT00598702|Primary|Number of Subjects Reporting at Least One Serious Treatment Emergent Adverse Event|"A Serious Treatment Emergent Adverse Event is defined as any untoward medical occurrence at any dose of IV APAP that;
results in death
is life-threatening
requires inpatient hospitalization or causes prolongation of existing hospitalization
results in persistent or significant disability/incapacity
is a congenital anomaly/birth defect
is an important medical event"|First dose to 30 days after last dose|All analysis will be carried out using the safety population, defined as all subjects who received at least one dose of study medication.||Subjects|||Number
755670|NCT00598702|Secondary|Physician's Global Assessment of Study Treatment|Physicians were asked to evaluate the overall study treatment using a 4-point categorical evaluation scale (0= poor, 1= fair,2=good, 3= excellent).|End of study or Early Termination|All analysis will be carried out using the safety population, defined as all subjects who received at least one dose of study medication.||participants|||Number
755671|NCT00598702|Primary|Number of Subjects Reporting at Least One Treatment Emergent Adverse Event (TEAE)|A TEAE is defined as an adverse event that starts on or after the start of study medication.|First dose to end of treatment period|All analysis will be carried out using the safety population, defined as all subjects who received at least one dose of study medication.||Subjects|||Number
755672|NCT00598702|Secondary|Subject's (Parent/Guardian) Global Evaluation of Study Treatment|Subject's (parent/guardian) was asked to evaluate the overall study treatment using a 4-point categorical evaluation scale (0= poor, 1= fair, 2=good, 3= excellent).|Day 0 to Day 5, Day 7 or Early Termination from study|All analysis will be carried out using the safety population, defined as all subjects who received at least one dose of study medication.||participants|||Number
755681|NCT00598819|Primary|Overheating of Skin Underneath Sensor|"The Principal measure for this outcome was discomfort and potential harm from overheating while attached to an active study participant. The investigator of the study asked to the participant if he/she felt:
• Discomfort in the sensor application zone; Itching, Burning sensation and/or Pain. The skin was examined before and after the sensor application. All the assessments were performed by the principal investigator of the study."|placement of sensor to immediately post-removal|||Participants|||Number
755682|NCT00598819|Secondary|Sensor Attachment Under Stress|"The Principal measure for this outcome was discomfort and potential harm from overheating while attached to an active study participant. The investigator of the study asked to the participant if he/she felt:
• Discomfort in the sensor application zone; Itching, Burning sensation and/or Pain. The skin was examined before and after the sensor application. All the assessments were performed by the principal investigator of the study."|addition of stress on sensor to removal.|||Participants|||Number
755703|NCT00599131|Secondary|The Difference, From Baseline, in EGFR, for Tumor Biopsies Taken After the Administration of Cetuximab Following TPF.|To determine tumor EGFR degradation, as well as other markers of down-stream EGFR inhibition, observed in tumor biopsies taken shortly after the administration of cetuximab following TPF, compared with pre-treatment biopsies.|Day 23|The study was discontinued prematurely due to an early stopping rule. No participants were assessed because an insufficient number of patients were recruited.|||||
755683|NCT00598819|Secondary|Sensor Fits Well on Subjects Forehead|"How well the sensor seems to fit on the subject's forehead in terms of curvature, comfort and adherence. The fitting assessment was assessed visually and determined based in the size of the sensor and the length of forehead covered, also the adhesion test was performed by hanging weight of 2 LBS on the sensor for 10 min, recording if the sensor kept attached to the skin or not. All tests and measures were assessed by the investigator. All the characteristics of the sensor (curvature, comfort and adherence) were recorded on each subjects as yes or no."|placement of sensor to end of study observation|||Participants|||Number
755684|NCT00598819|Primary|Overheating of Skin Underneath Sensor.|"The Principal measure for this outcome was discomfort and potential harm from overheating while attached to an active study participant. The investigator of the study asked to the participant if he/she felt:
• Discomfort in the sensor application zone; Itching, Burning sensation and/or Pain. The skin was examined before and after the sensor application. All the assessments were performed by the principal investigator of the study."|placement of sensor to 10 minutes post-removal.|||Participants|||Number
755685|NCT00598819|Primary|Harm to Skin From Attachment of Sensor to Forehead: Cuts, Bruising, Rash or Allergic Reactions to Adhesive.|Measurement of reactions to the sensor's attachment to the skin on the forehead. Measurement of the outcome is either reaction or no reaction. This means that all subjects are either measured as having a reaction at all or having no reaction at all. Measurement and reactions assessment performed by the investigator.|attachment of sensor to 24 hours post-removal|The number of participants was determined by protocol specifications.||Participants|||Number
755686|NCT00598832|Primary|Co-Primary Endpoint: Absolute Change in NonInflammatory Lesion Counts From Baseline to Week 12||Baseline to Week 12|||Absolute Change in Non-Infl Lesion count||Standard Error|Least Squares Mean
755687|NCT00598832|Primary|Co-Primary Endpoint: Absolute Change in Inflammatory Lesion Count From Baseline to Week 12||Baseline to Week 12|||Absolute Change in Infl Lesion count||Standard Error|Least Squares Mean
755688|NCT00598832|Primary|Co-Primary Endpoint: Absolute Change in Total Lesion Count From Baseline to Week 12||Baseline to Week 12|||Absolute Change in Total Lesion Count||Standard Error|Least Squares Mean
755689|NCT00598832|Secondary|Mean Percent Change in Total Lesion Count From Baseline to Week 12|Percent change in lesion count from baseline to week 12|From Baseline to Week 12|||% Change in Lesion Count||Standard Deviation|Mean
755690|NCT00598832|Primary|Co-Primary Endpoint: Success Rate on Investigator's Global Assessment (IGA) From Baseline to Week 12|"Success defined as percentage of subjects who achieved at least a two-grade reduction in IGA scale (e.g from moderate to clear or almost clear)at week 12 from baseline, Last Observation Carried Forward, Intent to treat population. The IGA (Investigator Global Assessment) is defined as a 5 point scale (0 to 4). 0 = clear , 1= almost clear, 2= mild, 3= moderate, 4=severe."|From Baseline to Week 12|||Percentage of Participants|||Number
755691|NCT00598871|Secondary|Number of Participants With Corneal Epithelial Wound Healing at Day 14 (End of Treatment)|Number of diabetic patients who had undergone epithelial debridement during vitrectomy resulted in complete corneal wound closure of the affected eye at the end of treatment (Day 14)|14 days|Analysis per protocol, ITT (Intent to treat), using LOCF (Last Observation Carried Over)||participants|||Number
755692|NCT00598871|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) After Treatment With Thymosin Beta 4 in the Target Eye of Diabetic Patients During Vitrectomy|Number of participants with Number of Treatment Emergent Adverse Events (TEAEs) in the Target Eye in diabetic patients who had undergone epithelial debridement during vitrectomy and treated with thymosin beta 4|14 days|Intent to Treat (ITT), Last Observation Carried Forward (LOCF)||Participants|||Number
755693|NCT00599014|Secondary|Hospitalization||30 days|||participants|||Number
755694|NCT00599014|Primary|Death, Heart Transplant, Left Ventricular Assist Device Implantation||5 years|||participants|||Number
755695|NCT00599027|Primary|The Change of the Rhinasthma Global Summary Score From Baseline to Endpoint After 28 Days of Treatment.|To explore the efficacy of mometasone furoate nasal spray in comparison with placebo in improving the quality of life of subjects with moderate-severe PER and intermittent asthma as measured by the Rhinasthma Questionnaire (Global Summary Score). The Rhinasthma is a questionnaire that consists of 30 items and for each of them subjects had to indicate on a Likert scale (1=not at all; 5=very much) the degree of limitation or discomfort caused by each problem. Possible total best score = 150 and possible total worst score = 30.|Baseline and 28 days of treatment|||units on a scale||Standard Deviation|Mean
755696|NCT00599053|Primary|Safety of Azithromycin Treatment for Eradication of Ureaplasma Spp. in Preterm Infants|Number of serious of adverse event experienced by subjects treated with azithromycin|from day 1 of study drug through 100 days or discharge from hospital, which ever comes first|||number of events||Full Range|Mean
755697|NCT00599053|Primary|Pharmacokinetics (PK) of Azithromycin Treatment for Eradication of Ureaplasma Spp. in Preterm Infants|Pharmacokinetic measures (AUC12) of subjects receiving azithromycin who had eradication of ureaplasma spp.at either day 100 or discharge day which ever comes first.|100 days or discharge from hospital|Unable to determine Pharmacokinetics (PK) data due to low enrollment|||||
755698|NCT00599053|Secondary|Respiratory Outcomes as Determined by Subjects Without Respiratory Tract Ureaplasma Spp Infection in Subjects in the Two Treatment Groups|Absence of Ureaplasma spp infection is determined by the total number of days with positive pressure ventilation, (conventional ventilation or nasal continuous positive pressure) and oxygen therapy. The mean number of days was used to compare the two treatment groups.|from baseline to 100 days or discharge from Hospital, which ever comes first|||days||Full Range|Mean
755699|NCT00599053|Primary|Microbiological Efficacy of Azithromycin Treatment for Eradication of Ureaplasma Spp. in Preterm Infants|Number of subjects without ureaplasma spp at 100 days after study entry or at hospital discharge in subjects receiving therapy|100 days or discharge from hospital|Unable to determine efficacy due to low enrollment|||||
755700|NCT00599131|Secondary|The Number of Patients That Experience Grade 3 and 4 Mucositis or Dysphagia|To determine and compare toxicities, most notably mucositis and dysphagia, in patients on this treatment regimen as compared to historical controls.|3 years.|The study was discontinued prematurely due to an early stopping rule. No participants were assessed because an insufficient number of patients were recruited.|||||
755701|NCT00599131|Secondary|Overall Survival Time|To determine the overall survival rates compared to the overall survival rates of historical controls.|3 years|The study was discontinued prematurely due to an early stopping rule. No participants were assessed because an insufficient number of patients were recruited.|||||
755704|NCT00599131|Primary|Percentage of Patients Achieving Histologic Complete Response|The proportion of patients treated with radiation+cetuximab achieving histologic CR will be estimated, along with 95% exact confidence intervals. Histologic Complete Response (CR) will be defined as primary tumors exhibiting a clinical CR or at least a 90% PR (Partial Response) along with a negative post-treatment biopsy.|3 years|The study was discontinued prematurely due to an early stopping rule. No participants were assessed for the primary outcome because an insufficient number of patients were recruited.|||||
755705|NCT00599196|Secondary|Mean Epworth Sleepiness Scale Score During the Open-label Extension|The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire with 8 questions. The total ESS score is the sum of 8 item-scores and can range between 0 and 24. The higher the score, the higher the person's level of daytime sleepiness.|Visit 10 (end of year 1), Visit 14 (end of year 2), Visit 18 (end of year 3), Visit 22 (end of year 4), Visit 26 (end of year 5), Visit 30 (end of year 6), End of Treatment (last study visit or early withdrawal visit)|Of the 380 subjects who are included in the Safety Set (SS), 5 subjects discontinued prior to entering the maintenance phase (n=375), however 2 of these subjects returned for the End of Treatment visit (n=377). Last observation carried forward (LOCF) was utilized for subjects who entered the maintenance phase.||Score on a scale||Standard Deviation|Mean
755706|NCT00599196|Secondary|Number of Subjects Who Withdrew From the Trial Due to an Adverse Event|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|six years|Of the 381 subjects who entered the study, 380 are included in this summary based on the Safety Set (SS). One subject was excluded from the safety set because he withdrew consent prior to receiving any Open Label study medication.||Subjects|||Number
755707|NCT00599196|Primary|Number of Subjects With at Least One Adverse Event During This Open-label Extension Study|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|six years|Of the 381 subjects who entered the study, 380 are included in this summary based on the Safety Set (SS). One subject was excluded from the safety set because he withdrew consent prior to receiving any Open Label study medication.||Subjects|||Number
755708|NCT00599248|Secondary|Number of Patients With Improvements in Pain and Function of the Knee Joint|Assessment of the number of patients with improvement in pain and function of the knee joint|28 Days|||participants|||Number
755709|NCT00599248|Secondary|Number of Patients With Tissue Overgrowth or Transformation in the Knee Joint|Visual and histological analysis of knee joint tissues to determine the number of patients with tissue overgrowth or transformation|29|||participants|||Number
755710|NCT00599248|Secondary|Number of Participants With Observable Evidence of Cartilage Regeneration|The evaluation of regeneration of hyaline cartilage as determined by histological analysis of resected knee tissue and observation for engraftment and cartilage production.|Days 0, 3, 7, 11, 28 (prior to surgery), and day 29 (one day post-surgery) following dosing. Follow-up patient monitoring will be performed at 3, 6, 9, and 12 months following dosing|Intention-to-treat||participants|||Number
755711|NCT00599248|Secondary|Number of Patients With Distribution of hChonJb#7 Cells Detected Outside of the Injection Site|Number of Patients with Distribution of hChonJb#7 Cells Detected Outside of the Injection Site as determined by PCR analysis for vector DNA.|12 Months|||participants|||Number
755712|NCT00599248|Secondary|Number of Patients Showing Engraftment at the Defect|Dose Response of the TG-C in Engrafting at the Defect as Compared to Placebo Control|28 Days|||participants|||Number
755713|NCT00599248|Primary|Summary of Adverse Events|The incidence of observations at the site of administration and the incidence adverse events assessed through 28 days after treatment.|Through 28 days post-dosing|Intention-to-treat||Adverse events|||Number
755714|NCT00599313|Secondary|Percentage of Participants With Decrease in Present Pain Intensity (PPI) From Baseline.|Pain score decreased >=2 points from baseline. The PPI scale has the following descriptors: 0=no pain, 1=mild pain, 2=discomforting pain, 3=distressing pain, 4=horrible pain, and 5=excruciating pain. The patient will be asked to self-assess and record their PPI in the study diary. Upon diary review, the study nurse will utilize the PPI daily scores to calculate the week’s average. The weekly PPI score during the study is the average of the daily PPI scores, based on a minimum of 3 daily PPI assessments during a week’s period.|12 months|Patients with pain measurement at baseline.||percentage of participants||95% Confidence Interval|Number
755715|NCT00599313|Secondary|Objective Response Rate (ORR) st|OORR = Complete Response (CR) + Parcial response (PR). CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.RR = Completed response (CR) + Partial response (PR).|12 months|Only patients with baseline measurable lesions.||percentage of participants||95% Confidence Interval|Number
755716|NCT00599313|Secondary|Change of PSA Doubling Time|Difference of PSA doubling time between baseline and end of the treatment.|Baselie and up to 12 months|Patients who had measurements of prior and post doubling time.||months||Full Range|Median
755717|NCT00599313|Secondary|Prostate Specific Antigen (PSA) Response|PSA value declined to 50% when compared to the value at the baseline.|12 months|Evaluable population||percentage of participants||95% Confidence Interval|Number
755718|NCT00599313|Secondary|Overal Survival (OS) Rate at 1-year.|OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.|12 months|ITT population||Probability of Survival at 1-year||95% Confidence Interval|Number
755719|NCT00599313|Primary|Median Progression-free Survival (PFS) Time at 1-year.|"PFS is measured from the date of registration to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions."|12 months|ITT population||weeks||Full Range|Median
755720|NCT00599326|Secondary|Number of Participants Showing Decrease in Ferritin and Urinary Porphyrin Level|Patients with PCT usually have normal or elevated serum iron and ferritin levels as well as increased iron absorption. Phlebotomy is conducted to analyzes the ferritin levels. Urine collection is performed and samples of the urine are analyzed for porphyrin levels.|6 months|||participants|||Number
755721|NCT00599326|Primary|Number of Participants Showing Reduction or Elimination of Skin Blistering|The present trial was undertaken to determine if oral deferasirox could be useful in the treatment of PCT. Monthly clinic visits with a physical examination was conducted to assess the skin for blisters.|Within 6 months of treatment.|||participants|||Number
755722|NCT00599339|Secondary|Reported Adverse Events of Cardiac Valve Fibrosis During the Study (up to 33 Months)|The analysis was performed for the non-disjunctive classification into patients at risk to develop an Adverse Event associated with Rotigotine and patients at risk to develop an Adverse Event not associated with Rotigotine.|33 months|For analysis of Safety the patients in the Safety Set were sub-grouped into patients at risk developing an Adverse Event (AE) associated with rotigotine and patients at risk developing an AE not associated with rotigotine. This sub-grouping is non-disjunctive in nature, i.e. one patient might fall into both subgroups.||Adverse Events|||Number
755723|NCT00599339|Secondary|Hoehn & Yahr Stage at Visit 7 (Month 33)|"The Hoehn and Yahr staging of Parkinson’s disease in the “on” stage, if applicable, had to be completed by the physician.
Possible staging:
0 No signs of disease
1 Unilateral disease
2 Bilateral disease without impairment of balance
3 Mild to moderate bilateral disease, some postural instability, physically dependent
4 Severe disability, still able to walk or stand unassisted
5 Wheelchair bound or bedridden unless aided"|33 months|"All enrolled and treated patients, having at least one valid on-treatment measurement in any efficacy variable are included in the Full Analysis Set (FAS).
Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study."||participants|||Number
755724|NCT00599339|Secondary|Change From Baseline in Nocturnal Dystonia Cramp Score (NADCS) at Visit 7 (Month 33)|"The NADCS assesses sleep-related motor complaints including nocturnal akinesia, dystonia and painful cramps by an ordinal severity scale.
The NADCS total score ranges from 0 (normal) to 4 (maximum severity). NADCS value was missing for one subject at Visit 7."|33 months|"All enrolled and treated patients, having at least one valid on-treatment measurement in any efficacy variable are included in the Full Analysis Set (FAS).
Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study."||units on a scale||Standard Deviation|Mean
755725|NCT00599339|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 39 of Part IV at Visit 7 (Month 33)|"The Unified Parkinson’s disease rating scale (UPDRS) Part IV question 39 asks “What proportion of the waking day is the patient off, on average? Answers range from 0 (None) to 4 (76-100 % of the day)."|33 months|"All enrolled and treated patients, having at least one valid on-treatment measurement in any efficacy variable are included in the Full Analysis Set (FAS).
Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study."||units on a scale||Standard Deviation|Mean
755726|NCT00599339|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 33 of Part IV at Visit 7 (Month 33)|The Unified Parkinson’s disease rating scale (UPDRS) Part IV question 33 asks for complications of therapy in the past week, through the question “How disabling are the dyskinesias ? “ Answers range from 0 (Not disabling) to 4 (Completely disabling).|From Baseline to Visit 7 (Month 33)|"All enrolled and treated patients, having at least one valid on-treatment measurement in any efficacy variable are included in the Full Analysis Set (FAS).
Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study."||units on a scale||Standard Deviation|Mean
755727|NCT00599339|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 32 of Part IV at Visit 7 (Month 33)|"The Unified Parkinson’s disease rating scale (UPDRS) question 32 of part IV asks. What Proportion of the waking day are dyskinesias present? Answers range from 0 (None) to 4 (76-100 % of the day)."|From Baseline to Visit 7 (Month 33)|"All enrolled and treated patients, having at least one valid on-treatment measurement in any efficacy variable are included in the Full Analysis Set (FAS).
Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study."||units on a scale||Standard Deviation|Mean
755728|NCT00599339|Primary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III at Visit 7 (Month 33)|The Unified Parkinson’s disease rating scale (UPDRS) Part III (Motor Examination) contains 31 questions. Each question ranges from 0 (best possible outcome) to 4 (worst outcome). The total score ranges from 0 (best possible outcome) to 124 (worst outcome).|From Baseline to Visit 7 (Month 33)|"All enrolled and treated patients, having at least one valid on-treatment measurement in any efficacy variable are included in the Full Analysis Set (FAS).
Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study."||units on a scale||Standard Deviation|Mean
755729|NCT00599521|Primary|Co-Primary Endpoint: Absolute Change in NonInflammatory Lesion Counts From Baseline to Week 12||Baseline to Week 12|||Absolute Change in Non-Infl Lesion||Standard Error|Least Squares Mean
755730|NCT00599521|Primary|Co-Primary Endpoint: Absolute Change in Inflammatory Lesion Count From Baseline to Week 12||Baseline to Week 12|||Absolute Change in Infl Lesion count||Standard Error|Least Squares Mean
755731|NCT00599521|Secondary|Mean Percent Change in Total Lesion Count From Baseline to Week 12|Percent change in lesion count from baseline to week 12|From Baseline to 12 weeks|||% Change in Lesion Count||Standard Deviation|Mean
755732|NCT00599521|Primary|Co-Primary Endpoint: Absolute Change in Total Lesion Counts From Baseline to Week 12||Baseline to 12 weeks|||Absolute Change in Total Lesion Count||Standard Error|Least Squares Mean
755733|NCT00599521|Primary|Co-Primary Endpoint: Success Rate on Investigator's Global Assessment (IGA) From Baseline to Week 12|"Success defined as percentage of subjects who achieved at least a two-grade reduction in IGA scale (e.g from moderate to clear or almost clear)at week 12 from baseline, Last Observation Carried Forward, Intent to treat population. The IGA (Investigator Global Assessment) is defined as a 5 point scale (0 to 4). 0 = clear , 1= almost clear, 2= mild, 3= moderate, 4=severe."|From Baseline to Week 12|||Percentage of Participants|||Number
755810|NCT00588952|Primary|Biphasic Alcohol Effects Scale (BAES) - Subscale Sedation|Self-reporting rating scale to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol|80 minutes|All available data was utilized in the analysis using mixed models||units on a scale||Standard Deviation|Mean
755734|NCT00599755|Post-Hoc|Metabolic Response Conversion Rate Between 3 and 6 Weeks After Starting Chemotherapy At a Threshold of a 30% Decrease in SUVmean|Metabolic response conversion rate is the number of participants initially classified as non-metabolic responders relative to baseline at week 3 after starting chemotherapy, who are then, relative to week 3, reclassified as metabolic responders at week 6 after starting chemotherapy, based on a pre-specified threshold of a 30% decrease in SUVmean of [18F]-Fluorodeoxyglucose (FDG). The SUVmean was calculated by summing the radioactivity from volumes of interest within each tumor and normalizing for the injected dose and lean body mass.|Weeks 3 and 6 following chemotherapy|Participants with evaluable scans classified as non-metabolic responders relative to baseline at 3 Weeks after starting chemotherapy||Participants|||Number
755735|NCT00599755|Secondary|Change in FGD-PET Uptake From Baseline to Week 6|"Fold change in SUVmean of FDG uptake with accompanying 80% Confidence Interval.
The SUVmean was calculated by summing the radioactivity from volumes of interest within each tumor and normalizing for the injected dose and lean body mass."|Baseline and Week 6|Participants with PET scans at baseline and 6 weeks after starting chemotherapy.||Fold change in SUVmean||90% Confidence Interval|Number
755736|NCT00599755|Secondary|Change in FDG-PET Uptake From Week 3 to Week 6|Fold change in SUVmean of FDG uptake with accompanying 80% Confidence Interval. The SUVmean was calculated by summing the radioactivity from volumes of interest within each tumor and normalizing for the injected dose and lean body mass.|Week 3 and Week 6|Participants with PET scans at 3 weeks and 6 weeks after starting chemotherapy||Fold change in SUVmean||90% Confidence Interval|Number
755737|NCT00599755|Secondary|Change in FDG-PET Uptake From Baseline to Week 3|Fold change in SUVmean of FDG uptake with accompanying 80% Confidence Interval. The SUVmean was calculated by summing the radioactivity from volumes of interest within each tumor and normalizing for the injected dose and lean body mass.|Baseline and Week 3|Participants with PET scans at baseline and 3 weeks after starting chemotherapy||Fold Change in SUVmean||90% Confidence Interval|Number
755738|NCT00599755|Secondary|Repeatability of FDG SUVmean at Baseline|Two positron emission tomography (PET) scans are obtained on different days at baseline, as close together as possible, under conditions of no biological change, to measure FDG SUVmean. The SUVmean was calculated by summing the radioactivity from volumes of interest within each tumor and normalizing for the injected dose and lean body mass.|Between -14 to -6 days and between -5 to 0 days prior to starting chemotherapy|Participants who underwent two baseline PET scans||SUVmean||Standard Deviation|Geometric Mean
755739|NCT00599755|Primary|Metabolic Response Conversion Rate Between 3 and 6 Weeks After Starting Chemotherapy at a Threshold of a 20% Decrease in SUVmean|Metabolic response conversion rate is the number of participants initially classified as non-metabolic responders relative to baseline at week 3 after starting chemotherapy, who are then, relative to week 3, reclassified as metabolic responders at week 6 after starting chemotherapy, based on a pre-specified threshold of a 20% decrease in mean standardized uptake value (SUVmean) of [18F]-Fluorodeoxyglucose (FDG). The SUVmean was calculated by summing the radioactivity from volumes of interest within each tumor and normalizing for the injected dose and lean body mass.|Weeks 3 and 6 following chemotherapy|Participants with evaluable scans classified as non-metabolic responders relative to baseline at 3 Weeks after starting chemotherapy||Participants|||Number
755740|NCT00599872|Secondary|Scores on a Scale (The Average Combined Allergy Symptom and Medication Score During the Ragweed Season for Each Subject)|The average combined allergy symptom and medication score during the ragweed season for each subject. This score is computed for each subject by adding their daily relief medication scores (excluding beta-agonist use) and their daily RSS for the entire ragweed season, and then taking the average of the combined scores across days.|Ragweed pollen season 08/01/08 to 10/30/08|The modified ITT population: subjects with 12 weeks or more of treatment (based on subject consent date and date of ragweed season for the site)||Scores on a scale||Standard Deviation|Least Squares Mean
755741|NCT00599872|Secondary|Scores on a Scale (Total Allergy Relief Medication Score During the Ragweed Season) for Each Subject|Total allergy relief medication score during the ragweed season for each subject. This score is computed for each subject by summing their individual medication scores (excluding beta-agonist use) for the entire ragweed season. High scores were indicative of poor symptom relief from the study medication. The associated relief medication scores assigned to medication are 0-if no medication taken; 3 for each one antihistamine tablet taken; 1 for each 2 antihistamine eye drop administrations, 1 for each 2 antihistamine nasal spray administrations and 1 for each puff of beta-agonist. The maximum medication score was dependent on the cumulative rescue medication use. The lower result the more favorable.|Ragweed pollen season 08/01/08 to 10/30/08|The modified ITT population: subjects with 12 weeks or more of treatment (based on subject consent date and date of ragweed season for the site)||Scores on a scale||Standard Deviation|Least Squares Mean
755742|NCT00599872|Secondary|Scores on a Scale (Average Daily RSS During the Ragweed Season for Each of the Three Organ) Systems (Ocular, Nasal, Ears);|The average daily RSS during the ragweed season for each of the 3 organ systems (ocular, nasal, ears) were separately analyzed to evaluate these individual components of the RSS. Three separate baseline average daily RSS values were computed for this analysis. The modified ITT population was used for this analysis. The range for scores: 0 to 3 for each of eight symptom or a total of 0 to 24 daily RSS. A lower score was more favorable.|Ragweed pollen season 08/01/08 to 10/30/08|The modified ITT population: subjects with 12 weeks or more of treatment (based on subject consent date and date of ragweed season for the site)||Scores on a scale||Standard Deviation|Least Squares Mean
755743|NCT00599872|Secondary|Scores on a Scale (Average Daily AM RSS and the Average Daily PM RSS During the Ragweed Season)|"Symptom score defined as sum of scores from eight symptoms rated 0-3 (0=absent, 1=mild, 2=moderate, 3=severe): ocular (itchiness, swelling/redness, and watery eyes/tears), nasal (sneezing, itching, runny and stuffy nose), and ears (itching). Average daily RSS ranged from 0-48; A lower score was more favorable.
The average daily RSS (the sum of the 8 individual allergy symptoms recorded in the morning (AM RSS) and the evening (PM RSS)."|Ragweed pollen season 08/01/08 to 10/30/08|The modified ITT population: subjects with 12 weeks or more of treatment (based on subject consent date and date of ragweed season for the site)||Scores on a scale||Standard Deviation|Least Squares Mean
755811|NCT00588952|Primary|Biphasic Alcohol Effects Scale (BAES) - Subscale Sedation|Self-reporting rating scale to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol|45 minutes|All available data was utilized in the analysis using mixed models||units on a scale||Standard Deviation|Mean
755744|NCT00599872|Secondary|Scores on a Scale (Average Daily RSS During the Highest Pollen Count Week)|"Symptom score defined as sum of scores from eight symptoms rated 0-3 (0=absent, 1=mild, 2=moderate, 3=severe): ocular (itchiness, swelling/redness, and watery eyes/tears), nasal (sneezing, itching, runny and stuffy nose), and ears (itching). Average daily RSS ranged from 0-48; A lower score was more favorable.
The average daily RSS was computed for each subject by: (1) summing the 8 individual allergy symptoms recorded in the morning (AM RSS) and the evening (PM RSS); (2) forming the daily RSS by summing the AM RSS and the PM RSS for each day of the ragweed season; (3) averaging the daily RSS for the entire ragweed pollen season.
The highest pollen count week was defined as the 7 contiguous days from the series with the largest average pollen count, and in which the weekly average was computed using at least 4 non-missing daily RSS values (either AM or PM could be present to be considered a valid daily RSS value)."|09/01/2008-09/07/2008|The modified ITT population: subjects with 12 weeks or more of treatment (based on subject consent date and date of ragweed season for the site)||scores on a scale||Standard Deviation|Least Squares Mean
755745|NCT00599872|Primary|Scores on a Scale (Average of Daily Rhinoconjunctivitis Symptom Score (RSS) Recorded During the Ragweed Season|"Symptom score defined as sum of scores from eight symptoms rated 0-3 (0=absent, 1=mild, 2=moderate, 3=severe): ocular (itchiness, swelling/redness, and watery eyes/tears), nasal (sneezing, itching, runny and stuffy nose), and ears (itching). Average daily RSS ranged from 0-48; A lower score was more favorable.
The average daily RSS was computed for each subject by: (1) summing the 8 individual allergy symptoms recorded in the morning (AM RSS) and the evening (PM RSS); (2) forming the daily RSS by summing the AM RSS and the PM RSS for each day of the ragweed season; (3) averaging the daily RSS for the entire ragweed pollen season."|Ragweed pollen season, 08/01/08 to 10/30/08, approximately 3 months|The modified ITT population: subjects with 12 weeks or more of treatment (based on subject consent date and date of ragweed season for the site)||Scores on a scale||Standard Deviation|Least Squares Mean
755746|NCT00599924|Secondary|Initial Area Dnder the Contrast Agent Concentration-Time Curve (IAUC) of Tumors in a Selected Group of Subjects Assessed by DCE-MRI|IAUC: The initial area under the curve was estimated by integrating the area under the contrast agent concentration time course for the first 90 seconds after bolus arrival in the tumor.|Cycle 3 (Day 1) and Cycle 3 (Day 8)|No pharmacodynamic assessments were performed due to limited number of DCE-MRI scans collected.|||||
755747|NCT00599924|Secondary|Volume Endothelial Transfer Constant (Ktrans) of Tumors in a Selected Group of Subjects Assessed by Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI)|Volume endothelial Ktrans was estimated by fitting the tissue contrast agent time course to the Kety equation (Tofts model for analysis of DCE-MRI data).|Cycle 3 (Day 1), Cycle 3 (Day 8)|No pharmacodynamic assessments were performed due to limited number of DCE-MRI scans collected.|||||
755748|NCT00599924|Secondary|Cmin of Free Platinum, Total Platinum, and 5-FU||pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose|Cmin was not calculated for Free Platinum, Total Platinum, and 5-FU.|||||
755749|NCT00599924|Secondary|CL/F of Free Platinum, Total Platinum, and 5-FU|CL/F = dose divided by area under the plasma concentration-time profile from time zero to twenty-four hours.|pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose|CL/F was not calculated for Free Platinum, Total Platinum, and 5-FU.|||||
755750|NCT00599924|Secondary|T1/2 of Free Platinum, Total Platinum, and 5-FU|t1/2 = terminal phase half-life. t1/2 was obtained by ln2 divided by kel. Oxaliplatin was metabolized to platinum and free and total platinum were measured.|pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose|T1/2 was not calculated for Free Platinum, Total Platinum, and 5-FU.|||||
755751|NCT00599924|Secondary|Cmax of 5-FU||pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose|Cmax of 5-FU was not calculated.|||||
755752|NCT00599924|Secondary|Area Under the Curve (AUC) of 5-FU||pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose|AUC for 5-FU was not calculated.|||||
755753|NCT00599924|Secondary|Steady State Clearance (CLss) of 5-FU|CLss was determined by total amount of drug received during infusion or duration of infusion (Ki) divided by Css.|pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose|ITT population of subjects who had completed PK blood sampling for at least one day.||L/hr||Standard Deviation|Mean
755754|NCT00599924|Secondary|Steady State Concentration (Css) of Fluorouracil (5-FU)|Steady state is reached when the amount of drug getting into the system per unit time is equal to the amount of drug cleared from the system.|pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose|ITT population of subjects who had completed PK blood sampling for at least one day.||ng/mL||Standard Deviation|Mean
755755|NCT00599924|Secondary|Area Under the Plasma Concentration-Time Profile From Time Zero to Forty-Eight Hours (AUC48) for Total Platinum|Oxaliplatin was metabolized to platinum and total platinum was measured. AUC48 = Area under the plasma concentration-time profile from time zero (pre-dose) to forty-eight hours. AUC48 was obtained by the Linear/Log trapezoidal method.|pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose|ITT population of subjects who had completed PK blood sampling for at least one day.||ng*hr/mL||Standard Deviation|Mean
755756|NCT00599924|Secondary|Tmax of Total Platinum|Oxaliplatin was metabolized to platinum and total platinum was measured.|pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose|ITT population of subjects who had completed PK blood sampling for at least one day.||hours||Full Range|Median
755757|NCT00599924|Secondary|Cmax of Total Platinum|Oxaliplatin was metabolized to platinum and total platinum was measured.|pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose|ITT population of subjects who had completed PK blood sampling for at least one day.||ng/mL||Standard Deviation|Mean
755758|NCT00599924|Secondary|T1/2 for Free Platinum|t1/2 = terminal phase half-life. t1/2 was obtained by ln2 divided by kel. Oxaliplatin was metabolized to platinum and free platinum was measured.|pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose|ITT population of subjects who had completed PK blood sampling for at least one day.||hours||Standard Deviation|Mean
755812|NCT00588952|Primary|Biphasic Alcohol Effects Scale (BAES) - Subscale Sedation|Self-reporting rating scale to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol|15 minutes|All available data was utilized in the analysis using mixed models||units on a scale||Standard Deviation|Mean
755759|NCT00599924|Secondary|Area Under the Plasma Concentration-Time Profile From Time Zero to Infinity (AUCinf) for Free Platinum|Oxaliplatin was metabolized to platinum and free platinum was measured. AUCinf = Area under the plasma concentration-time profile from time zero (pre-dose) to infinity. AUCinf was obtained by the Linear/Log trapezoidal method.|pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose|ITT population of subjects who had completed PK blood sampling for at least one day.||ng*hr/mL||Standard Deviation|Mean
755760|NCT00599924|Secondary|Tmax of Free Platinum|Oxaliplatin was metabolized to platinum and free platinum was measured.|pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose|ITT population of subjects who had completed PK blood sampling for at least one day.||hours||Full Range|Median
755761|NCT00599924|Secondary|Cmax of Free Platinum|Oxaliplatin was metabolized to platinum and free platinum was measured.|pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose|ITT population of subjects who had completed PK blood sampling for at least one day.||ng/mL||Standard Deviation|Mean
755762|NCT00599924|Secondary|T1/2 of SU-012662 (Sunitinib's Metabolite)|t1/2 = terminal phase half-life. t1/2 was obtained by ln2 divided by kel.|pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose|T1/2 for SU-012662 was not calculated due to short observation time.|||||
755763|NCT00599924|Secondary|CL/F of SU-012662 (Sunitinib's Metabolite)|CL/F = dose divided by area under the plasma concentration-time profile from time zero to twenty-four hours.|pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose|CL/F was not calculated for SU-012662.|||||
755764|NCT00599924|Secondary|AUC24 for SU-012662 (Sunitinib's Metabolite)|AUC24 = Area under the plasma concentration-time profile from time zero (pre-dose) to twenty-four hours. AUC24 was obtained by the Linear/Log trapezoidal method.|pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose.|ITT population of subjects who had completed PK blood sampling for at least one day.||ng*hr/mL||Standard Deviation|Mean
755765|NCT00599924|Secondary|Cmin of SU-012662 (Sunitinib's Metabolite)||pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose|||ng/mL||Standard Deviation|Mean
755766|NCT00599924|Secondary|Tmax of SU-012662 (Sunitinib's Metabolite)||pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose|ITT population of subjects who had completed PK blood sampling for at least one day.||hours||Full Range|Median
755767|NCT00599924|Secondary|Cmax of SU-012662 (Sunitinib's Metabolite)||pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose|ITT population of subjects who had completed PK blood sampling for at least one day.||ng/mL||Standard Deviation|Mean
755768|NCT00599924|Secondary|Terminal Phase Half-Life (t1/2) of Sunitinib|t1/2 = terminal phase half-life. t1/2 was obtained by natural log of 2 (ln2) divided by the rate constant for terminal phase (kel).|pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose|T1/2 for sunitinib was not calculated due to short observation time.|||||
755769|NCT00599924|Secondary|Area Under Plasma Concentration-Time Profile From Time Zero to Twenty-Four Hours Postdose (AUC24) of Sunitinib|AUC24 = Area under the plasma concentration-time profile from time zero (pre-dose) to twenty-four hours. AUC24 was obtained by the Linear/Log trapezoidal method.|pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose|ITT population of subjects who had completed PK blood sampling for at least one day.||ng*hr/mL||Standard Deviation|Mean
755770|NCT00599924|Secondary|Clearance (CL/F) of Sunitinib|Drug clearance (CL/F) = dose divided by area under the plasma concentration-time profile from time zero to twenty-four hours.|pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose|ITT population of subjects who had completed PK blood sampling for at least one day.||L/hr||Standard Deviation|Mean
755771|NCT00599924|Secondary|Minimum Plasma Concentration (Cmin) of Sunitinib||pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose|ITT population of subjects who had completed PK blood sampling for at least one day.||ng/mL||Standard Deviation|Mean
755772|NCT00599924|Secondary|Time to Cmax (Tmax) of Sunitinib||pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose|ITT population of subjects who had completed PK blood sampling for at least one day.||hours||Full Range|Median
755773|NCT00599924|Secondary|Maximum Plasma Concentration (Cmax) of Sunitinib||pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose|ITT population of subjects who had completed pharmacokinetic (PK) blood sampling for at least one day.||ng/mL||Standard Deviation|Mean
755774|NCT00599924|Secondary|Objective Response (OR)|From the start of treatment until disease progression/recurrence. OR=confirmed Complete Response (CR) or confirmed Partial Response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR = disappearance of all target lesions. CR was confirmed if it persisted on repeat imaging study ≥ 4 weeks after initial documentation of response. PR = ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. PR was confirmed if it persisted on repeat imaging study ≥ 4 weeks after initial documentation of response.|From start of treatment until Day 8 of Cycles 4 and 8 (2/2 Schedule), Day 8 of Cycles 3 and 6 (4/2 Schedule), and Day 1 of Cycles 3 and 7 (Continuous Dosing)|ITT||participants|||Number
755775|NCT00599924|Primary|Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)|All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product(s) were reported.|up to 20 weeks|Intent to treat (ITT) = all subjects enrolled in the study that received at least one dose of study medication. Subjects who did not complete the follow-up period for dose limiting toxicity assessment because of death from progressive disease or other non-treatment related events were replaced.||participants|||Number
755776|NCT00600015|Secondary|Overall Survival (OS)||18 months|||Months||95% Confidence Interval|Median
755777|NCT00600015|Secondary|6-month PFS||6 months||||||
755778|NCT00600015|Secondary|Duration of Response||18 months||||||
755779|NCT00600015|Secondary|Disease Control Rate (DCR)||18 months||||||
755780|NCT00600015|Primary|Progression Free Survival (PFS)||18 months|||Months||95% Confidence Interval|Median
755781|NCT00600015|Primary|Overall Objective Response Rate (ORR)||18 months|||Percent||95% Confidence Interval|Number
755813|NCT00588952|Primary|Biphasic Alcohol Effects Scale (BAES) - Subscale Sedation|Self-reporting rating scale to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol|Baseline|All available data was utilized in the analysis using mixed models||units on a scale||Standard Deviation|Mean
755814|NCT00588965|Secondary|Tpeak-end Interval (Tpe)|Tpeak-end interval was measured at rest, exercise, and recovery on placebo and on propranolol.|Measured after 2 weeks on each intervention|||ms||Standard Deviation|Mean
755782|NCT00600028|Secondary|Efficacy of Thalidomide in Suppressing the Chronic Cough of Idiopathic Pulmonary Fibrosis Using the Visual Analog Scale of Cough and the St. George Respiratory Questionnaire.|"The secondary endpoint, suppression of cough was measured by the visual analog scale of cough (VAS) was significantly lower during treatment with thalidomide than placebo.
Secondary endpoints were Cough VAS - the visual analog scale of cough evaluates the severity of cough in patients with IPF.
Visual analog scale of cough ranges from 0 to 100 (0 is considered the best).
St. George Respiratory Questionnaire helps to evaluate cough-specific and respiratory quality of life in patients with IPF.
St. George Respiratory Questionnaire score ranges from 0 to 100 (0 is considered the best)."|6 months|All participants who received the interventions and completed all study visits were included in the efficacy analysis.||units on a scale||Standard Deviation|Mean
755783|NCT00600028|Primary|Efficacy of Thalidomide in Suppressing the Chronic Cough of Idiopathic Pulmonary Fibrosis Using the Cough Quality of Life Questionnaire.|"The primary endpoint, suppression of cough was measured by the Cough Quality of Life Questionnaire (CQLQ) to measure the effect of interventions on cough-specific quality of life.
CQLQ consist of 28 questions about cough and its effects using Likert-like 4-point scales, with lower scores indicating less effect of cough on health related quality of life.
CQLQ scale ranges from 28 to 112 ( The lower the value, the higher the quality of life, 28 is considered the best)."|6 months|All participants who received the interventions and completed all study visits were included in the efficacy analysis.||units on a scale||Standard Deviation|Mean
755784|NCT00588731|Secondary|Overall Cognition as Measured on the MATRICS Battery|Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) is intended to provide a relatively brief evaluation of key cognitive domains relevant to schizophrenia and related disorders. A higher score indicates better cognition (i.e. speed of processing, attention, verbal and non-verbal working memory, visual learning, reasoning, problem solving, and social cognition). The below scores are t-score values, which are normalized scores to the population and comparing the scores to a representative sample.|6 weeks|||t-score||Standard Deviation|Mean
755785|NCT00588731|Primary|Verbal Short Term Memory|Verbal short term memory is measured through the Hopkins Verbal Learning Test. Each trial has a max total score of 12 (range of 0-12), and the max total score for all three trials is 36 (range of 0-36). However, the data listed below is reported in the form of a t-score, with a higher score representing better verbal learning. These t-score values are normalizing the scores to populations, comparing them to a representative sample, with a mean of 50.|6 weeks|||t-score||Standard Deviation|Mean
755786|NCT00588809|Secondary|Proportion of Subjects With KIT Mutation|Proportion of subjects with KIT mutation|baseline (0 weeks)|The analysis includes the 41 patients with samples available for analysis.||percentage of participants|||Number
755787|NCT00588809|Secondary|Proportion of Subjects With FLT3 ITD Mutation|Proportion of subjects with FLT3 ITD mutation|baseline (0 weeks)|FLT3 ITD mutation status was not available for one patient.||percentage of participants|||Number
755788|NCT00588809|Secondary|Proportion of Subjects With KRAS Mutation|Proportion of subjects with KRAS mutation|baseline (0 weeks)|The analysis includes the 41 patients with samples available for analysis.||percentage of participants|||Number
755789|NCT00588809|Secondary|Proportion of Subjects With NRAS Mutation|Proportion of Subjects With NRAS Mutation|baseline (0 weeks)|The analysis includes the 41 patients with samples available for analysis.||percentage of participants|||Number
755790|NCT00588809|Secondary|Proportion of Subjects With Baseline p-ERK Activation|Proportion of subjects with baseline p-ERK activation|baseline (0 weeks)|The analysis includes the 20 patients with samples available for analysis.||percentage of participants|||Number
755791|NCT00588809|Primary|Response Rate for Subjects Without FLT3 ITD Mutation|"Responses were defined using standard criteria developed by an International Working Group.
[Cheson BD, Bennett JM, Kopecky KJ, Buchner T, Willman CL, Estey EH, et al. Revised recommendations of the International Working Group for Diagnosis, Standardization of Response Criteria, Treatment Outcomes, and Reporting Standards for Therapeutic Trials in Acute Myeloid Leukemia. J Clin Oncol 2003;21:4642–9.]
In this primary outcome, we report the proportion of subjects without FLT3 ITD mutation that experienced a complete response (CR), partial response (PR), minor response (MR), or unconfirmed minor response (uMR)."|Up to 52 weeks|Analysis only includes subjects without FLT3 ITD mutation.||percentage of participants|||Number
755792|NCT00588822|Secondary|Percentage of Subjects With > 50% Reduction of Monoclonal Protein Titer at 6 Months|Monoclonal immunoglobulins measured included Immunoglobulin G (IgG), Immunoglobulin A (IgA), and Immunoglobulin M (IgM).|baseline, 6 months|||percentage of subjects||95% Confidence Interval|Number
755793|NCT00588822|Secondary|Percentage of Subjects Having One or More Stable Hand Grip Strength Ergometry Values for Either Hand at 6 Months|Grip strength was measured by a dynamometer in both hands at baseline and every three months until the final study visit. Response criteria was defined as achieving stable hand grip strength dynamometry values (no more than 10% better or worse relative to baseline at the 6 month visit on either side).|baseline, 6 months|||percentage of subjects||95% Confidence Interval|Number
755794|NCT00588822|Secondary|Percentage of Patients Having Improvement in the Hand Grip Strength Ergometry Value for Either Hand at 6 Months|Grip strength was measured by a dynamometer in both hands at baseline and every three months until the final study visit. Response criteria was defined as achieving improvement in hand grip strength dynamometry values (>10% better relative to baseline at the 6 month visit on either side).|baseline, 6 months|||percentage of subjects||95% Confidence Interval|Number
755795|NCT00588822|Secondary|Percentage of Subjects With at Least 1 Grade Improvement in the Modified Rankin Score at 6 Months|The Modified Rankin Scale was used to determine functional disability as follows: 0 = asymptomatic; 1 = symptoms not interfering with manual activities/walking normally; 2 = minor difficulties in manual activities/walking independently without support; 3 = unable to perform some manual activities/walking independently with support; 4 = unable to eat, dress or wash independently/needing assistance to walk; 5 = no useful tasks performed with upper limbs/confined to wheelchair. Therefore, scores could range from 0 to 5, with higher values indicating greater disability.|baseline, 6 months|||percentage of subjects||95% Confidence Interval|Number
755840|NCT00589550|Secondary|Overall Survival||up to 1 year||||||
755841|NCT00589550|Secondary|Response Rate of Patients Receiving Peginterferon Alfa-2b and Sorafenib.||up to 1 year||||||
755842|NCT00589550|Secondary|Progression-free Survival of Patients Receiving Peginterferon Alfa-2b and Sorafenib.||up to 1 year||||||
755796|NCT00588822|Secondary|Percentage of Subjects Whose Disease Has Stabilized or Responded, for Either Side of the Body, as Measured by NIS at 6 Months|"The Neuropathy Impairment Score (previously called the Neurologic Disability Score [NDS]) is derived from a neurologic examination obtained in a standard way by a specially trained neurologist. Decisions are based on the neurologist’s judgment of what is normal considering site, age, sex, weight, height, and physical fitness. The instrument has 35 items, each ranked for left and right sides of the body; weakness is scored 0=normal, 1=25% disability, 2=50% disability, 3=75% disability and 4=100% disability. NIS total score was calculated as the sum of the 35 items, ranging from 0 to 140, with higher score indicating greater disability or impairment.
The NIS score was measured on both sides of the body, the worst score recorded reported as 1 for each individual subject. Stability was defined as change of less than 10 points in the NIS total score. Improvement was defined as at least 10 points improvement in NIS total score, that is, reduction in the number of points on the scale."|baseline, 6 months|||percentage of subjects||95% Confidence Interval|Number
755797|NCT00588822|Primary|Percentage of Subjects With at Least 10 Points Improvement in the Neuropathy Impairment Score (NIS) for Either Side of the Body at 6 Months|"The Neuropathy Impairment Score [previously called the Neurologic Disability Score (NDS)] is derived from a neurologic examination obtained in a standard way by a specially trained neurologist. Decisions are based on the neurologist’s judgment of what is normal considering site, age, sex, weight, height, and physical fitness. The instrument has 35 items, each ranked for left and right sides of the body; weakness is scored 0=normal, 1=25% disability, 2=50% disability, 3=75% disability and 4=100% disability. NIS total score was calculated as the sum of the 35 items, ranging from 0 to 140, with higher score indicating greater disability or impairment.
The neurologist measured the NIS score on both sides of the body, but recorded worst score and reported as 1 for each individual subject (i.e., each subject had only 1 reported score.)
Improvement was defined as at least 10 points improvement in NIS total score, that is, reduction in the number of points on the scale."|baseline, 6 months|A dichotomous measure was used so that subjects who discontinued participation prematurely could be included as non-responders.||percentage of subjects||95% Confidence Interval|Number
755798|NCT00588848|Secondary|Cardiopulmonary Complications||72 hours||||||
755799|NCT00588848|Secondary|Apnea-Hypopnea Index (AHI)|Events are defined as apneas and hypopneas. AHI values are typically categorized as 5-14.9 events/hr = mild; 15-29.9 events/hr = moderate; and >= 30 events/hr = severe|On postoperative night number 1 from 2200 to 0600. Study participation will end within 72 hours of admission.|3 of the subjects randomized to the use of their usual CPAP slept less than 10 minutes on their night after surgery and thus were excluded from further analysis as the outcomes are based on events during sleep. Study was terminated early due to enrollment problems.||events per hour||Full Range|Mean
755800|NCT00588848|Primary|Sleep Related Hypoxemia||On postoperative night number 1 from 2200 to 0600. Study participation will end within 72 hours of admission.|3 of the subjects randomized to the use of their usual CPAP slept less than 10 minutes on their night after surgery and thus were excluded from further analysis as the outcomes are based on events during sleep.||Percentage of time < 90% saturation||Full Range|Mean
755801|NCT00588861|Primary|Harris Hip Score|"The Harris Hip Score is detailed below as a range. 100 being the highest score, and 0 being the lowest score. 90-100 is considered Excellent. 80-89 is considered Good. 70-79 is considered Fair. Less than 70 is considered Poor."|10 Years Post-Operative|This population represents patients that returned for follow-up per protocol. Because no patients returned at the primary outcome measure time frame (10 years), 0 patients were analyzed at 10 years.|||||
755802|NCT00588861|Secondary|Harris Hip Score Pain|"Harris Hip Score Pain is detailed below as mean score for the Harris Hip Score Pain question. 44 being the highest score, and 0 being the lowest score. 44 is considered None/Ignores. 40 is considered Slight/Occasional. 30 is considered Mild. 20 is considered Moderate. 10 is considered Marked. 0 is considered Totally Disabled."|Pre-Operative, 6 months, 1 year, 2 year, 4 year, 6 year, 8 year, 10 year|This population represents patients that returned for follow-up per protocol.||Mean Hip Pain||Standard Deviation|Mean
755803|NCT00588900|Secondary|Overall Survival|Overall Survival (OS) is defined as the time from patient randomization to death from any cause. The median OS with 95% CI was estimated using the Kaplan-Meier method.|Up to 2 years|Study terminated prematurely; due to patient confidentiality concerns this planned analysis was not performed.|||||
755804|NCT00588900|Secondary|Radiographic Response Rate|"The proportion of patients who respond (completely or partially) to each combination regimen will be estimated.
Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions."|Up to 2 years|Study terminated prematurely; due to patient confidentiality concerns this planned analysis was not performed.|||||
755805|NCT00588900|Primary|The Percentage of Patients Who Are Progression-free at 12 Weeks From the Start of Second-line Therapy|The 12 week progression-free rate was defined as the percentage of patients that were alive and progression-free 12 weeks after start of second-line therapy. Disease progression was assessed per modified RECIST criteria, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, in either primary or nodal lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of new lesions.|at 12 weeks|||percentage of participants|||Number
755806|NCT00588952|Primary|Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulation|Self-reporting rating scale to measure the stimulation effects (0 not at all stimulated - 70 extremely stimulated) of alcohol|80 minutes|All available data was utilized in the analysis using mixed models||units on a scale||Standard Deviation|Mean
755807|NCT00588952|Primary|Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulation|Self-reporting rating scale to measure the stimulation effects (0 not at all stimulated - 70 extremely stimulated) of alcohol|45 minutes|All available data was utilized in the analysis using mixed models||units on a scale||Standard Deviation|Mean
755808|NCT00588952|Primary|Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulation|Self-reporting rating scale to measure the stimulation effects (0 not at all stimulated - 70 extremely stimulated) of alcohol|15 minutes|All available data was utilized in the analysis using mixed models||units on a scale||Standard Deviation|Mean
755809|NCT00588952|Primary|Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulation|Self-reporting rating scale to measure the stimulation effects (0 not at all stimulated - 70 extremely stimulated) of alcohol|Baseline|All available data was utilized in the analysis using mixed models||units on a scale||Standard Deviation|Mean
755815|NCT00588965|Primary|QTc Response to Exercise on Versus Off Beta-blocker.|To minimize the effect of heart rate on QT, QT was measured at heart rates between 100 and 110 beats per minute during exercise (on and off beta-blocker) and during recovery (on and off beta-blocker).|2 weeks on each treatment then exercise test|Please note that this was a crossover study. There were 35 subjects and each subject completed both the placebo and beta-blocker arm.||ms||Standard Deviation|Mean
755816|NCT00589108|Secondary|Percentage of Knees Surviving at 5 Years|Kaplan-Meier analysis of five-year implant survival rate|5 years post-surgery|||percentage of knees|||Number
755817|NCT00589108|Secondary|Knee Society Stair Climbing Score|The stair-climbing portion of the Knee Society clinical rating system assigns a maximum score of 50 points for patients able to ascend and descend stairs in a normal fashion, 40 points for patients needing a rail to descend, 30 points for patients using a rail in both directions, 15 points for patients able to ascend but not descend at all, and 0 points for patients unable ascend or descend. Because stair ascent and descent put substantial demands on the patellofemoral joint, we used that portion of the Knee Society clinical rating system as a proxy for patellofemoral function in this study.|two years post-surgery, five years post-surgery|||units on a scale||Full Range|Mean
755818|NCT00589108|Secondary|Knee Society Pain Score|The Knee Society Pain Score includes walking and climbing stairs. The maximum score per knee is 50 indicating no pain, and 0 indicates severe pain. Therefore the total score (for both knees) could range from 0 to 100.|5 years post-surgery|||units on a scale||Standard Deviation|Mean
755819|NCT00589108|Secondary|Knee Society Function Score|The Knee Society Function Score considers only walking distance and stair climbing, with deductions for walking aids. The maximum function score, which is 100, is obtained by a patient who can walk an unlimited distance and go up and down stairs normally. The minimum function score is 0.|5 years post surgery|||units on a scale||Standard Deviation|Mean
755820|NCT00589108|Primary|Maximum Knee Flexion|The range of knee motion was measured clinically with use of a goniometer. Measurements were performed by physician assistants in the Department of Orthopedic Surgery who were blinded to the type of implant used. The subject was positioned supine on the examination table, and maximum active flexion was measured.|2 years post-surgery, 5 years post-surgery|||degrees||Full Range|Mean
755821|NCT00589472|Other Pre-specified|Levels of DHEA-S in Prostate Tissue||Up to 1 year||||||
755822|NCT00589472|Other Pre-specified|Levels of DHEA in Prostate Tissue||Up to 1 year||||||
755823|NCT00589472|Other Pre-specified|Levels of Androstenedione in Prostate Tissue||Up to 1 year||||||
755824|NCT00589472|Other Pre-specified|Levels of Androstenediol in Prostate Tissue||Up to 1 year||||||
755825|NCT00589472|Other Pre-specified|Levels of DHT in Prostate Tissue||Up to 1 year||||||
755826|NCT00589472|Other Pre-specified|Levels of Testosterone in Prostate Tissue||Up to 1 year||||||
755827|NCT00589472|Other Pre-specified|Gene Microarray Analysis||Up to 1 year||||||
755828|NCT00589472|Other Pre-specified|Gene Expression Analysis, Including AR Target Genes, PSA and TMPRSS2|Estimates and 95% confidence intervals for the proportion of patients with nondetectable levels of PSA and TMPRSS2 will be computed.|at 12 weeks||||||
755829|NCT00589472|Other Pre-specified|Safety and Tolerability of Androgen Depletion Therapy in Combination With Vorinostat as Assessed by Physical Examinations, Adverse Events, and Laboratory Assessments. Please See Adverse Events Section.|Adverse events will be monitored at each scheduled visit and throughout the study. Toxicity will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.|Up to 1 year||||||
755830|NCT00589472|Other Pre-specified|Protein Expression Analysis, Including AR Target Genes, PSA and TMPRSS2||Up to 1 year||||||
755831|NCT00589472|Secondary|Levels of Testosterone in Blood From Radical Prostatectomy Specimens||Up to 1 year|||ng/dL||95% Confidence Interval|Median
755832|NCT00589472|Secondary|Levels of PSA in Blood From Radical Prostatectomy Specimens||Up to 1 year|||ng/mL||95% Confidence Interval|Median
755833|NCT00589472|Secondary|Levels of DHT in Blood From Radical Prostatectomy Specimens||Up to 1 year|||ng/dL||95% Confidence Interval|Median
755834|NCT00589472|Secondary|Levels of DHEA-S in Blood From Radical Prostatectomy Specimens||Up to 1 year|||mcg/dL||95% Confidence Interval|Median
755835|NCT00589472|Secondary|Levels of DHEA in Blood From Radical Prostatectomy Specimens||Up to 1 year|||ng/dL||95% Confidence Interval|Median
755836|NCT00589472|Secondary|Gleason Score|A Gleason score is the sum of two numbers. Pathologist determines where the cancer is most prominent and assigns the primary grade, the secondary grade is assigned based on where the cancer is next most prominent. A score from one to five is assigned for each area based on how aggressive the tumor appears. A tumor with cell that appear close to normal is assigned a low Gleason score (six or below). A tumor with cells that appear clearly different from those of a normal prostate is assigned a high Gleason score (seven or above). A system of grading prostate cancer tissue based on how it looks under a microscope. Gleason scores range from 2 to 10 and indicate how likely it is that a tumor will spread. A low Gleason score means the cancer tissue is similar to normal prostate tissue and the tumor is less likely to spread; a high Gleason score means the cancer tissue is very different from normal and the tumor is more likely to spread.|Baseline|||units on a scale||95% Confidence Interval|Median
755837|NCT00589472|Primary|Pathologic Complete Response at the Time of Surgery|The primary endpoint will be pathologic complete response at the time of surgery. This represents the proportion of patients with no evidence of disease in the prostate (ie, the absence of tumor in the posttherapy pathology specimen) at the time of radical prostatectomy. Pathologic complete response at the time of surgery is the primary endpoint for this study. A Simon 2-stage optimal design that differentiates between response probabilities of 0.05 and 0.20 will be used in the analysis of the pathological complete response at 12 weeks (Type I error 10% and power 90%). A maximum of 38 pts were planned for accrual onto this study. If zero or one response was observed, then the trial was to be stopped. The design had power 0.90 for a population response proportion to 0.20 using a one-sided 0.10 size test. pT2 indicates that the cancer is confined to the prostate, while pT3 indicates that there is an extraprostatic extension of the cancer.|At 12 weeks|||Participants|||Count of Participants
755838|NCT00589550|Secondary|Circulating Levels of IFN-γ and IL-5 for Determination of Th1/Th2 Status and CD4+, CD25+, and FoxP3 Cell Number (T Regs) in Peripheral Blood||Up to 1 year||||||
755839|NCT00589550|Secondary|Activation of Interferon-induced Transcription Factors in Immune Cell Subsets by Flow Cytometry and Correlation of This Information With Clinical Outcome||up to 1 year||||||
755845|NCT00589563|Secondary|Incidence of Disease Relapse/Progression at 2 Years Post HSCT|Patients were evaluated for relapse/progression post transplant throughout the study. The cumulative incidence of relapse/progression was determined using competing risk analysis. Competing risks for relapse were non-relapse mortality and nonengraftment.|2 year point estimate was provided.|||Percentage of patients who relapsed||95% Confidence Interval|Number
755846|NCT00589563|Primary|Severity of Chronic GVHD|All Patients were considered for the evaluation of chronic GVHD severity.|Patients were evaluated until they developed chronic GVHD, a median of 130 days post HSCT|||participants|||Number
755847|NCT00589563|Primary|Cumulative Incidence of Chronic GVHD|Patients were evaluated for the development of chronic GVHD from 101 days post HSCT to last contact or documented evidence of the disease. The cumulative incidence of chronic GVHD was determined using competing risk analysis. Competing risks for GVHD were death and nonengraftment.|2 year point estimate was provided.|||Percentage of patients developing cGVHD||95% Confidence Interval|Number
755848|NCT00589563|Secondary|Event Free Survival at Two Years Post HSCT|Patients were evaluated for event free survival (EFS) throughout the study. Events were defined as death, relapse, progression, or nonengraftment. Kaplan Meier estimates were calculated as time from HSCT to event.|2 year point estimate was provided.|||Percentage of patients with an event||95% Confidence Interval|Number
755849|NCT00589563|Secondary|Overall Survival at Two Years Post HSCT|Patients were evaluated for survival (OS) throughout the study. Kaplan Meier estiamtes were calculated for overall survival using time from HSCT to death of any cause or for surviving patients last contact date.|2 year point estimate was provided.|||Percentage of patients who died||95% Confidence Interval|Number
755850|NCT00589563|Secondary|Non-relapse Mortality at Two Years Post HSCT|Patients were evaluated for non-relapse mortality (NRM) throughout the study. Non-relapse mortality was considered any death not attributable to relapse or disease progression. The cumulative incidence of NRM was determined using competing risk analysis. Competing risks for NRM were death due to disease progression, relapse and nonengraftment.|2 year point estimate was provided.|||Percentage of patients with a NRM||95% Confidence Interval|Number
755851|NCT00589563|Secondary|Non-relapse Mortality at 100 Days Post HSCT|Patients were evaluated for non-relapse mortality (NRM) throughout the study. Non-relapse mortality was considered any death not attributable to relapse or disease progression. The cumulative incidence of NRM was determined using competing risk analysis. Competing risks for NRM were death due to disease progression, relapse and nonengraftment.|100 day point estimate was provided|||Percentage of patients with a NRM||95% Confidence Interval|Number
755852|NCT00589563|Secondary|Occurence of Sinusoidal Obstructive Syndrome (SOS)|Participants were monitored throughout the trial (median of 28 months) for various infections/complications. This is the number of participants who developed SOS.|Median Follow Up: 28 Months (Range: 1-49 Months)|||participants|||Number
755853|NCT00589563|Secondary|Occurrence of Thrombotic Microangiopathy|Participants were monitored throughout the trial (median of 28 months) for various infections/complications. This is the number of participants who developed TMA.|Median Follow Up: 28 Months (Range: 1-49 months)|||participants|||Number
755854|NCT00589563|Secondary|Occurence of Infections Including Cytomegalovirus and Epstein-Barr Virus Reactivation|Participants were monitored throughout the trial (median of 28 months) for various infections/complications.|Median Follow Up: 28 months (Range: 1-49 months)|||participants|||Number
755855|NCT00589563|Secondary|Time to Platelet Count Recovery (Engraftment)|Platelet recovery is defined as the first date of three consecutive laboratory values ≥ 25 x 10^9 L obtained on different days.|Patients were evaluated until platelet recovery, a median of 14 days|27 of the 32 patients had platelet recovery.||Days||Full Range|Median
755856|NCT00589563|Secondary|Time to Absolute Neutrophil Count Recovery (Engraftment)|Absolute neutrophil count (ANC) recovery is defined as an ANC of ≥ 0.5 x 10^9/L (500/mm3) for three consecutive laboratory values obtained on different days|Patients were evaluated until neutrophil recovery, a median of 15 days post HSCT|28 of the 32 patients had absolute neutrophil count recovery.||Days||Full Range|Median
755857|NCT00589563|Primary|Severity of Acute GVHD|All patients were considered for the evaluation of the severity of acute GVHD.|100 Days Post HSCT|||participants|||Number
755858|NCT00589563|Primary|Cumulative Incidence of Grade II-IV Acute Graft-Versus-Host Disease (GVHD) at Day 100|Patients were evaluated for the development of acute GVHD within the first 100 days post HSCT. The cumulative incidence of grade II-IV acute GVHD was determined using competing risk analysis. Competing risks for acute GVHD were death and nonengraftment.|100 Days Post Hematopoietic Stem Cell Transplant (HSCT)|||Percentage of patients developing aGVHD||95% Confidence Interval|Number
755859|NCT00589602|Secondary|Number of Participants With Relapse-free Survival|number of patients that were still alive and relapse free|after 7 years of follow up|All patients that received treatment||participants|||Number
755860|NCT00589602|Secondary|Number of Participants Able to Receive T-cell Add Backs|Patients receive defined doses of donor T cells by IV infusion on days 45 and 100, in absence of active graft-versus-host disease (GVHD) requiring steroids.|through D+100|||participants|||Number
755861|NCT00589602|Secondary|Number of Participants With Duration of Absolute Neutropenia||D+100 from transplant|||participants|||Number
755862|NCT00589602|Secondary|The Rate of Acute Graft Versus Host Disease (GVHD)||D+100 from transplant|||participants|||Number
755863|NCT00589602|Primary|Treatment-related Mortality (TRM)|The complication rate in matched unrelated donor (MUD) allogeneic bone marrow transplant (allo BMT) is known to be high. Graft failure and severe graft versus host disease (GvHD) are the most significant contributors to treatment related mortality (TRM). This treatment regimen will be considered unacceptable if the number of patients that experience TRM is 55% or greater, and effective if TRM is 33% or less.|180 days after transplant|Patients that received treatment||participants|||Number
755864|NCT00589628|Primary|Effects of Infliximab on Uveitis Disease Activity.|Number of subjects with improvement in uveitis, defined as a two step decrease in level of inflammation (as defined by SUN criteria, AC cells, vitreous haze) or decrease to grade 0. A grading scheme of 0 indicating (<1 cell/ocular field) low levels of inflammation to 4+ indicating (>50 cells/ocular field) indicating high levels of inflammation.|9 months|1 subject lost to follow up||participants|||Number
755865|NCT00589667|Secondary|Median Overall Survival|To determine the median overall survival for patients with recurrent or metastatic Head and Neck Squamous Cell Carcinoma treated with pemetrexed and gemcitabine.|2 years|There were 25 assessable patients as described in the protocol.||months||Full Range|Median
755866|NCT00589667|Primary|Overall Objective Response|"To determine the objective radiologic response rate of pemetrexed and gemcitabine in patients with recurrent or metastatic Head and Neck Squamouse Cell Carcinoma.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|2 years|All assessable patients as indicated in the protocol.||participants|||Number
755867|NCT00589693|Secondary|28-day All-cause Mortality Rate|Number of deaths which occured up to 28 days of the study period due to all causes|Up to 28 days|Microbiological Intent-to-Treat (MITT) - subset of all ITT (all randomized patients who received at least a partial dose of study medication) patients who had at least 1 qualifying pneumonia pathogen.||Participants|||Number
755868|NCT00589693|Secondary|Number of Patients Who Had Emergence of P. Aeruginosa Resistance|Number of patients who had P. aeruginosa isolates with a 4 fold or greater increase in minimum inhibitory concentration (MIC) at anytime during the study (after the study medication is received) from baseline|Up to 6 weeks|Microbiological Intent-to-Treat (MITT) - subset of all ITT (all randomized patients who received at least a partial dose of study medication) patients who had at least 1 qualifying pneumonia pathogen.||Participants|||Number
755869|NCT00589693|Secondary|Clinical Cure Rate at the End-of-treatment (EOT) Visit in Patients From Whom at Least 1 of the Gram-negative Qualifying Pneumonia Pathogens (Enterobacteriaceae, P. Aeruginosa, and Acinetobacter Spp) Was Isolated at Baseline|The clinical cure rate at the EOT visit in patients whose BAL or mini-BAL culture results yielded at least 1 of the following Gram-negative qualifying pneumonia pathogens was isolated at baseline: any Enterobacteriaceae, P. aeruginosa, and Acinetobacter Spp.|End-of-treatment (Day 10 or Day 11)|Microbiological Intent-to-Treat (MITT) - subset of all ITT (all randomized patients who received at least a partial dose of study medication) patients who had at least 1 qualifying pneumonia pathogen.||Participants|||Number
755870|NCT00589693|Secondary|Clinical Cure Rate at the End-of-treatment (EOT) Visit in Patients From Whom a Qualifying P. Aeruginosa Was Isolated at Baseline|The clinical cure rate at the EOT visit in patients, whose bronchoalveolar lavage (BAL) or mini-BAL culture results yielded qualifying pneumonia pathogen P. aeruginosa at baseline.|End-of-treatment (Day 10 or Day 11)|Microbiological Intent-to-Treat (MITT) - subset of all ITT (all randomized patients who received at least a partial dose of study medication) patients who had at least 1 qualifying pneumonia pathogen.||Participants|||Number
755871|NCT00589693|Primary|Clinical Cure Rate at the End-of-treatment (EOT) Visit|The number of patients who achieved clinical cure at the EOT visit on Day 10. The patient's were classified as clinical cure if they had resolution of signs and symptoms and objective findings of pneumonia to such an extent that no further antimicrobial therapy was necessary.|End-of-treatment (Day 10 or Day 11)|Microbiological Intent-to-Treat (MITT) - subset of all ITT (all randomized patients who received at least a partial dose of study medication) patients who had at least 1 qualifying pneumonia pathogen.||Participants|||Number
755872|NCT00589784|Primary|Overall Objective Response|Determine the overall objective response|1.5 years|||participants|||Number
755873|NCT00589849|Primary|Event Free Survival at 1 Year|Survival without ventricular tachycardia/ventricular fibrillation (VT/VF) or sudden cardiac death at 1 year|12 months|||participants|||Number
755874|NCT00589849|Primary|Evaluate the Diagnostic Accuracy of TWA in Predicting Arrhythmic Events, Cardiovascular Mortality, and Total Mortality in Patients With Acute MI||30 days||||||
755875|NCT00589888|Primary|Changes in Systolic Blood Pressure|systolic blood pressure change from baseline during an oral 64-gram fat load in obese normotensive subjects.|at the end of the 8 hours|||mmHg||Standard Deviation|Mean
755876|NCT00589888|Primary|Changes in Systolic Blood Pressure From Baseline|systolic blood pressure change from baseline during an oral 32-gram fat load in obese normotensive subjects.|at the end of 8 hours|||mmHg||Standard Deviation|Mean
755877|NCT00589888|Primary|Changes in Systolic Blood Pressure|BP change from baseline during an 8-hour 20% intralipid @ 40cc/hr infusion in obese normotensive subjects.|at the end of 8 hours|||mmHg||Standard Deviation|Mean
755878|NCT00589888|Primary|Change in Systolic Blood Pressure|systolic blood pressure change from baseline during an 8-hour 20% intralipid @ 20cc/hr infusion in obese normotensive subjects.|at the end of 8 hours|||mmHg||Standard Deviation|Mean
755879|NCT00589888|Secondary|The Secondary Outcomes of Interest Are the Effects of Increased FFAs on BP, Endothelial Function and Inflammatory Markers After Oral Fat Load (Chylomicron Pathway) Versus IV Administration of Intralipid Infusion in Obese Normotensive Subjects.||Changes in BP assessed every 2 hours during the 8 hours study; Lipid changes assessed every 2 hours during the 8-hour study, and Flow-mediated dilatation, peripheral compliance, PWA, and HRV assessed at 0,4, and 8 hours||||||
755880|NCT00589888|Primary|Change in Systolic Blood Pressure|systolic blood pressure change from baseline during an 8-hour normal saline infusion in obese normotensive subjects.|at the end of the 8-hours|||mmHg||Standard Deviation|Mean
755881|NCT00589914|Secondary|The Change From Baseline in the PSP Score|The PSP scale is used to assess the degree of dysfunction a patient exhibits over a 7-day period within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The results of the assessment are converted to a numeric score. A score between 71 and 100 indicates a mild degree of difficulty; a score between 31 and 70 indicates a moderate degree of dysfunction, and a patient with a score of 30 or less has functioning so poor he or she requires intensive supervision.|Baseline to the last postrandomization assessment in the double-blind treatment period (approximately 13 weeks)|The intent-to-treat (ITT) analysis set of patients included those randomized to treatment after IEC/IRB approval of protocol Amendment INT-4 who received at least 1 injection of double-blind study drug and had at least 1 efficacy measurement during the double-blind treatment period.||Scores on a scale||Standard Deviation|Mean
755882|NCT00589914|Secondary|The Change From Baseline for the CGI-S Score|The CGI-S rating scale is used to rate the severity of a patient’s psychotic condition on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe). This scale permits a global evaluation of the patient’s condition at a given time. A qualified rater administered the CGI-S.|Baseline to the last postrandomization assessment in the double-blind treatment period (approximately 13 weeks)]|The intent-to-treat (ITT) analysis set of patients included those randomized to treatment after IEC/IRB approval of protocol Amendment INT-4 who received at least 1 injection of double-blind study drug and had at least 1 efficacy measurement during the double-blind treatment period.||Scores on a scale||Standard Deviation|Mean
755883|NCT00589914|Primary|Change in the Positive and Negative Syndrome Scale (PANSS) Total Score for Schizophrenia|The PANSS scale is used to assess the neuropsychiatric symptoms of schizophrenia. The 30-item PANSS scale provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items),and the general psychopathology subscale (16 items), each item rated on a scale of 1 (absent) to 7 (extreme).|Baseline to the last postrandomization assessment in the double-blind treatment period (approximately 13 weeks)|The per-protocol analysis set of patients included those randomized to treatment after IEC/ IRB approval of protocol Amendment INT-4 with both a baseline measurement and at least 1 postrandomization measurement on the primary efficacy variable, a minimum exposure of 36 days to the double-blind treatment regimen, and no major protocol violations.||Scores on a scale||Standard Deviation|Mean
755884|NCT00589979|Other Pre-specified|Overall Treatment Difference in LSMeans for Verran Snyder-Halpern (VSH) Sleep Scale|The VSH Sleep Scale is contained in a 15 item self-report instrument that measures the quality of a patient’s sleep over the last 24 hours. Each item is scored on a 0-100 visual analog scale. The VSH is categorized into 3 sleep scales: disturbance (which measures delays and interruptions in sleep)[maximum score = 700], effectiveness (which measures how well sleep refreshed the individual) [maximum score = 600], and supplementation (which measures the need for napping) [maximum score = 400]. The higher the score the greater the value of the sleep characteristic for that patient.|Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks)|The modified intent-to-treat (MITT) population consisted of all intent-to-treat (ITT) patients defined as all patients who received study medication and provided run-in and baseline assessments and had at least 1 post-baseline efficacy assessment and who were randomized on or after January 22, 2008.||Units on a scale||Standard Error|Least Squares Mean
755885|NCT00589979|Other Pre-specified|Quality of Life: Three-Category EuroQol Quality of Life Instrument (EQ-5D) General Health Today Compared to Last 12 Months|Health status was assessed using the EuroQol Quality of Life Instrument (EQ-5D). Patients completed the EQ-5D assessment at Baseline and at the end of each period or at premature discontinuation. Categories included Better, Much the Same, and Worse.|Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks), or Premature Discontinuation|The modified intent-to-treat (MITT) population consisted of all intent-to-treat (ITT) patients defined as all patients who received study medication and provided run-in and baseline assessments and had at least 1 post-baseline efficacy assessment and who were randomized on or after January 22, 2008.||Participants|||Number
755886|NCT00589979|Other Pre-specified|Overall Treatment Difference in LSMeans for Continuous EuroQol Quality of Life Instrument (EQ-5D) Health Status Today Using a Visual Analog Scale (VAS)|Health status was assessed using the EuroQol Quality of Life Instrument (EQ-5D). Patients completed the EQ-5D assessment at Baseline and at the end of each period or at premature discontinuation. Values of the continuous EQ-5D health state today (VAS) ranged from 0 (worst imaginable health state) to 100 (best imaginable health state).|Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks), or Premature Discontinuation|The modified intent-to-treat (MITT) population consisted of all intent-to-treat (ITT) patients defined as all patients who received study medication and provided run-in and baseline assessments and had at least 1 post-baseline efficacy assessment and who were randomized on or after January 22, 2008.||Units on a scale||Standard Error|Least Squares Mean
755887|NCT00589979|Secondary|Investigator Global Assessment of Treatment Satisfaction|At the end of each period, investigators rated their overall satisfaction with study treatment using a 5-point categorical scale ranging from 0 (very dissatisfied) to 4 (very satisfied).|Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks)|The modified intent-to-treat (MITT) population consisted of all intent-to-treat (ITT) patients defined as all patients who received study medication and provided run-in and baseline assessments and had at least 1 post-baseline efficacy assessment and who were randomized on or after January 22, 2008.||Participants|||Number
755888|NCT00589979|Secondary|Patient Global Assessment of Treatment Satisfaction|At the end of each period, patients rated their overall satisfaction with study treatment using a 5-point categorical scale indicating: 0 - very dissatisfied; 1 - dissatisfied; 2 - no preference; 3 - satisfied; and 4 - very satisfied.|Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks)|The modified intent-to-treat (MITT) population consisted of all intent-to-treat (ITT) patients defined as all patients who received study medication and provided run-in and baseline assessments and had at least 1 post-baseline efficacy assessment and who were randomized on or after January 22, 2008.||Participants|||Number
755889|NCT00589979|Other Pre-specified|Overall Treatment Difference in LSMeans for Continuous EuroQol Quality of Life Instrument (EQ-5D) Index Scores|Health status was assessed using the EuroQol Quality of Life Instrument (EQ-5D). Patients completed the EQ-5D assessment at Baseline (Day 0) and at each clinic visit (at least every 4 weeks) or at premature discontinuation. Values of the EQ-5D index score range from -1 (worst) to 1 (best).|Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks), or Premature Discontinuation|The modified intent-to-treat (MITT) population consisted of all intent-to-treat (ITT) patients defined as all patients who received study medication and provided run-in and baseline assessments and had at least 1 post-baseline efficacy assessment and who were randomized on or after January 22, 2008.||Units on a scale||Standard Error|Least Squares Mean
755890|NCT00589979|Other Pre-specified|Quality of Life: Four Category Beck Depression Inventory Second Edition (BDI-II) Composite Score|The BDI-II is a 21-item self-report instrument intended to assess the existence and severity of symptoms of depression. Patients were to consider each item as it related to the way they felt for the previous 2 weeks. Each of the 21 items corresponding to a symptom of depression was summed to give a single score for the BDI-II, with a 4-point scale for each item ranging from 0-3. A total score of 0-13 is minimal, 14-19 is mild, 20-28 is moderate, and 29-63 is severe. Values were based on measurements taken at Screening, at Baseline (Visit 3), and at the end of each period.|Screening, Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks)|The modified intent-to-treat (MITT) population consisted of all intent-to-treat (ITT) patients defined as all patients who received study medication and provided run-in and baseline assessments and had at least 1 post-baseline efficacy assessment and who were randomized on or after January 22, 2008.||Participants|||Number
756041|NCT00591344|Secondary|Cognitive Function - Brief Test of Attention|This is a cognitive test of an individuals ability to remember number. It is a test of working memory.|obtained during initial evaluation & then every 6 six months to end of 2-yr training period||||||
755891|NCT00589979|Other Pre-specified|Overall Treatment Difference in LSMeans of Beck Depression Inventory Second Edition (BDI-II) Total Score|The BDI-II is a 21-item self-report instrument intended to assess the existence and severity of symptoms of depression. Patients were to consider each item as it related to the way they felt for the previous 2 weeks. Each of the 21 items corresponding to a symptom of depression was summed to give a single score for the BDI-II, with a 4-point scale for each item ranging from 0-3. A total score of 0-13 is minimal, 14-19 is mild, 20-28 is moderate, and 29-63 is severe. Values were based on measurements taken at Screening, at Baseline (Visit 3), and at the end of each period.|Baseline and end of treatment period (up to 4 weeks)|The modified intent-to-treat (MITT) population consisted of all intent-to-treat (ITT) patients defined as all patients who received study medication and provided run-in and baseline assessments and had at least 1 post-baseline efficacy assessment and who were randomized on or after January 22, 2008.||Units on a scale||Standard Error|Least Squares Mean
755892|NCT00589979|Secondary|Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain|"Investigators rated their overall impression of change from Baseline to the end of each period during the double-blind treatment period, including premature discontinuation. Change was rated using a categorical scale ranging from very much worse to very much improved. A similar questionnaire was completed by the Investigator."|Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks)|The modified intent-to-treat (MITT) population consisted of all intent-to-treat (ITT) patients defined as all patients who received study medication and provided run-in and baseline assessments and had at least 1 post-baseline efficacy assessment and who were randomized on or after January 22, 2008.||Participants|||Number
755893|NCT00589979|Secondary|Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain|"Patients rated their overall impression of change from Baseline to the end of each period during the double-blind treatment period, including premature discontinuation. Change was rated using a categorical scale indicating: very much worse (0); much worse (1); minimally worse (2); no change (3); minimally improved (4); much improved (5); and very much improved (6)."|Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks)|The modified intent-to-treat (MITT) population consisted of all intent-to-treat (ITT) patients defined as all patients who received study medication and provided run-in and baseline assessments and had at least 1 post-baseline efficacy assessment and who were randomized on or after January 22, 2008.||Participants|||Number
755894|NCT00589979|Secondary|Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores|The PQAS measures individual pain qualities and the impact of treatment on those qualities. Items 1-19 are each rated on an 11-point scale ranging from 0 (lowest score - no pain of that type) to 10 (highest score - the highest level of that type of pain). Average surface pain = average of PQAS items: cold, sensitive, itchy, numb, and tingling. Average deep pain = average of PQAS items: dull, cramping, throbbing, aching, and heavy. Average paroxymal pain = average of PQAS items: sharp, shooting, electric, and radiating.|Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks)|The modified intent-to-treat (MITT) population consisted of all intent-to-treat (ITT) patients defined as all patients who received study medication and provided run-in and baseline assessments and had at least 1 post-baseline efficacy assessment and who were randomized on or after January 22, 2008.||Units on a scale||Standard Error|Least Squares Mean
755895|NCT00589979|Secondary|Overall Treatment Difference in the LSMeans of the Average of the Last Two Daily Pain Relief Scale (PRS) Scores|The Pain Relief Scale (PRS) is a 9-point categorical rating scale to assess pain relief during the 24-hours since the last assessment; 0= completely worse and 8= complete pain relief. Patients completed this assessment each day during the run-in period and each day during the double-blind treatment phase in their e-diary.|Baseline, End of Period 1 (up to 4 weeks), End of Period 2 (up to 4 weeks) and End of Period 3 (up to 4 weeks)|The modified intent-to-treat (MITT) population consisted of all intent-to-treat (ITT) patients defined as all patients who received study medication and provided run-in and baseline assessments and had at least 1 post-baseline efficacy assessment and who were randomized on or after January 22, 2008.||Units on a scale||Standard Error|Least Squares Mean
755896|NCT00589979|Secondary|Overall Treatment Difference in the LSMeans of the Average of the Last Two Daily Pain Intensity Numerical Rating Scale (PI-NRS)|"The Numerical Rating Scale (NRS) is an 11-point categorical rating scale to assess pain intensity (PI-NRS); 0= no pain and 10= worst possible pain. The scale is anchored on the left with No Pain and on the right with Worst Possible Pain. Patients were to complete this assessment at approximately the same time each day during the double-blind treatment period in their e-diary. The overall treatment difference for the Lidoderm (lidocaine patch 5%) and placebo patch was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence."|Baseline, End of Period 1 (up to 4 weeks), End of Period 2 (up to 4 weeks) and End of Period 3 (up to 4 weeks)|The modified intent-to-treat (MITT) population consisted of all intent-to-treat (ITT) patients defined as all patients who received study medication and provided run-in and baseline assessments and had at least 1 post-baseline efficacy assessment and who were randomized on or after January 22, 2008.||Units on a scale||Standard Error|Least Squares Mean
755897|NCT00589979|Secondary|Exit Status From Current Study Treatment - Yes|Exit status from a current study treatment was categorized as yes or no for patients who exited prior to the 4-week planned duration. This analysis supports the results of the primary analysis. The number of patients exiting (yes) is reported.|Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks), or Premature Discontinuation|The modified intent-to-treat (MITT) population consisted of all intent-to-treat (ITT) patients defined as all patients who received study medication and provided run-in and baseline assessments and had at least 1 post-baseline efficacy assessment and who were randomized on or after January 22, 2008.||Participants|||Number
755911|NCT00590135|Secondary|Rate of Change in Aortic Valve Area as Measured by TEE Compared to Standard of Care Group|Poor reducibility of aortic valve area measurements with transthoracic echocardiography images resulted in the primary outcome measure not being obtained. Thus, comparison to the stand of care group was not possible.|2 years|Poor reducibility of aortic valve area measurements with transthoracic echocardiography images resulted in the primary outcome measure not being obtained. Thus, comparison to the stand of care group was not possible.|||||
756042|NCT00591344|Secondary|Cognitive Function - Stroop Test|This is a test of cognitive function. This test requires individuals to first say as many colors as they can under three different test conditions.|obtained during initial evaluation & then every 6 six months to end of 2-yr training period||||||
755898|NCT00589979|Secondary|Time-to-Exit Due to Lack of Efficacy|"Time-to-exit due to lack of efficacy was defined as a patient that met the switching criterion (a 2-category change in Pain Relief Scale (PRS) in the worsening direction [increasing pain or decreasing pain relief] for 2 consecutive days) or was discontinued from the current period or study due to lack of efficacy. The PRS is a 9-point categorical rating scale to assess pain relief in the last 24 hours in which 0 = completely worse and 8 = complete pain relief.
No patients discontinued from the study due to lack of efficacy."|Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks), or Premature Discontinuation|"The modified intent-to treat (MITT) population consisted of all intent-to-treat (ITT) patients who were randomized on or after January 22, 2008.
Note: No patients exited a study period due to lack of efficacy, therefore median time-to-exit could not be calculated."||days||95% Confidence Interval|Median
755899|NCT00589979|Primary|Time-to-Exit From Current Study Treatment|Time-to-exit was defined as the number of days at which a patient either met the switching criterion [a 2-category change in the Pain Relief Scale (PRS) score in the worsening direction (increasing pain or decreasing pain relief) for 2 consecutive days] or discontinued from the study. The PRS is a 9-point categorical rating scale to assess pain relief in the last 24 hours in which 0 = completely worse and 8 = complete pain relief. Traditional survival models that consider event times (e.g. median survival time) as independent and homogeneous across patients were not suitable for this study.|Baseline, Period 1 (up to 4 weeks ±2 days), Period 2 (up to 4 weeks ±2 days), Period 3 (up to 4 weeks ±2 days), or Premature Discontinuation|"The modified intent-to treat (MITT) population consisted of all intent-to-treat (ITT) patients who were randomized on or after January 22, 2008.
Note: Kaplan-Meier estimates for median time-to-exit from current study treatment could not be calculated for Period 2 or Period 3, because the survival distribution function did not fall below 0.5000."||Days||95% Confidence Interval|Median
755900|NCT00590005|Secondary|Reduction in Breath pH|Breath condensate pH was measured by the RTube (trademark) device. This device is a plastic tube with a one-way exhalation valve and a chilled aluminum sleeve. pH (the log of hydrogen ion concentration) was measured using an Orion pH meter and probe calibrated in 4.0, 7.0, and 10.0 pH solutions.|baseline and 21 days|225 children with asthma were enrolled in the study and completed baseline assessments. Only 40 children were followed longitudinally. The data from those 40 children are shown here.||log of hydrogen ion concentration (pH)||Standard Deviation|Mean
755901|NCT00590005|Primary|Exhaled Nitric Oxide at Baseline and Over the Observational Period|Exhaled nitric oxide concentrations as measured by collection of exhaled breath into a mylar bag|baseline and after 21 days|225 children were enrolled into the study and completed baseline assessments. Only 40 children were followed longitudinally. The results from only those 40 children are shown here.||parts per billion||Standard Deviation|Mean
755902|NCT00590018|Secondary|Change in Inotrope Score. This is the Change in the Inotrope Score Between 15 Minutes Prior to Drug Administration and at 2 Days After Drug Administration.|Inotrope score: epinephrine (mcg/kg/min x 100) + norepinephrine (mcg/kg/min x 100) + phenylephrine (mcg/kg/min x 100) + dopamine (mcg/kg/min x1) + dobutamine (mcg/kg/min x 1) + milrinone (mcg/kg/min x15). A lower inotrope score is better with the minimum being 0 and the maximum being 85.|2 days|||units on a scale||Standard Deviation|Mean
755903|NCT00590018|Primary|Blood Pressure.|Change in mean blood pressure recorded prior to (15 minutes prior to study drug) and subsequent to medication/placebo administration (at 2 days post drug administration).|2 days|||mmHg||Standard Deviation|Mean
755904|NCT00590031|Secondary|Evaluate Toxicity and Tolerability Including Surgical Morbidity and Mortality||2 years|||participants|||Number
755905|NCT00590031|Primary|Pathologic Complete Response|Pathological information will be available for all patients who receive surgery. If a patient is deemed unresectable based on clinical and radiological examination after the therapy, that patient will be counted as non-responder. The best overall response is the best response recorded from the start of treatment until disease progression (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The subject’s best response assignment will depend on the achievement of both measurement and confirmation criteria. We will also estimate the pathological complete response rates separately for each of these tumor types. Survival and disease-free survival will be estimated using Kaplan-Meier method. With an accrual rate of 3 patients a month, we expect the study to be completed in 18 months.|2 years|||participants|||Number
755906|NCT00590044|Secondary|Frequency of Hyperglycemia|differences between treatment groups in the number of hyperglycemic episodes (blood glucose > 200 mg/dl).|blood glucose (BG) before meals, at bedtime and as needed||||||
755907|NCT00590044|Primary|Mean Daily Blood Glucose Concentration After the Resolution of DKA|The primary outcome during the subcutaneous (SC) period (the primary outcome measurement) was to determine differences in glycemic control as measured by mean daily blood glucose(BG) concentration between treatment groups.|1 year|||mg/dl||Standard Deviation|Mean
755908|NCT00590044|Secondary|Frequency of Hypoglycemia|differences between treatment groups in the number of hypoglycemic events (blood glucose < 60 mg/dl) between hours 12 to 36 (second day)|blood glucose (BG) before meals, at bedtime and as needed||||||
755909|NCT00590044|Secondary|Mean Daily Blood Glucose Concentration While on the Insulin Drip|determine differences in glycemic control as measured by differences in the mean daily blood glucose levels between treatment groups (insulin drip with regular insulin vs glulisine insulin) during the acute phase of diabetic ketoacidosis(DKA)|blood glucose (BG) before meals and at bedtime||||||
755910|NCT00590135|Secondary|Change in Mean and Peak Gradients Across the Aortic Valve as Measured by TEE in the Treated Group Compared to Historical Control Group.|Poor reducibility of aortic valve area measurements with transthoracic echocardiography images resulted in the primary outcome measure not being obtained. This secondary measurement was not obtained as it was deemed not relevant in the absence of the primary outcome measurement and other secondary outcome measurements.|2 years|Poor reducibility of aortic valve area measurements with transthoracic echocardiography images resulted in the primary outcome measure not being obtained. This secondary measurement was not obtained as it was deemed not relevant in the absence of the primary outcome measurement and other secondary outcome measurements.|||||
755949|NCT00590590|Secondary|Change From Baseline in Overall Vulvar Vestibulitis Syndrome (VVS)-Related Discomfort Visual Analog Scale (VAS) Score at End of Treatment (12 Weeks) [0 = No Discomfort and 100 = Most Severe Discomfort]||12 Weeks|||Score||Standard Error|Mean
756043|NCT00591344|Secondary|Functional Reach|The distance one can reach forward without taking a step.|Obtained during initial evaluation & then every 6 six months to end of 2-yr training period||||||
755912|NCT00590135|Secondary|Rate of Change in the Aortic Valve Area Measured by TEE Compared to That of Historical Controls|Poor reducibility of aortic valve area measurements with transthoracic echocardiography images resulted in primary measure not being obtained. As the outcome measurement was not obtained, comparison to historical controls was not possible.|2 years|Poor reducibility of aortic valve area measurements with transthoracic echocardiography images resulted in primary measure not being obtained. As the outcome measurement was not obtained, comparison to historical controls was not possible.|||||
755913|NCT00590135|Secondary|Rate of Change in the Aortic Valve Area Measured by Transthoracic Echocardiography Compared to That of Historical Controls|Rate of change in the aortic valve area measured by transthoracic echocardiography compared to that of historical controls was not obtained. Primary outcome measurement was not obtainable, thus comparison to historic controls was not possible.|2 years|Primary outcome measurement was not obtainable, thus comparison to historic controls was not possible.|||||
755914|NCT00590135|Primary|Aortic Stenosis|aortic valve area as measured by transthoracic echocardiography was not obtained due to poor reproducibility|2 years|Population had aortic stenosis, however the primary endpoint of Aortic Valve Area was not obtainable due to poor reproducibility. As a result, the study was terminated.|||||
755915|NCT00590161|Primary|Histological Improvement of at Least 2 Points in NAFLD Activity Score (NAS) on Liver Biopsy After One Year.|The NAFLD Activity Score (NAS) grades NAFLD on liver biopsy based on the individual scoring of steatosis, inflammation and balloning. The NAS is assessed on a scale of 0 to 8 with higher scores indicating more severe disease and lower scores indicating less severe disease. NAS is obtained by adding steatosis(assessed on a scale of 0 to 3), inflammation (assessed on a scale of 0 to 3) and ballooning (assessed on a scale of 0 to 2).|1 year (Baseline liver biopsy done at study entry, and subsequent liver biopsy done after one year of therapy with pentoxifylline or placebo)|Intention to treat analysis included all participants and for this analysis patients without available end of study liver biopsy were imputed as treatment failures. Results showed here are continuous variable analysis of NAS score change in patients with available end of study liver biopsy (per protocol analysis)||NAS score units||Standard Deviation|Mean
755916|NCT00590226|Secondary|Number of Patients With Hypoglycemic Events|number of patients with hypoglycemic events as defined as BG 40-59 mg/dl|during hospitalization|||participants|||Number
755917|NCT00590226|Primary|Mean AM BG (mg/dl)|average AM daily BG with detemir insulin once daily plus insulin aspart before meals and NPH insulin twice daily plus regular insulin before meals in patients with DM2|during hospitalization|||mg/dl||Standard Deviation|Mean
755918|NCT00590317|Secondary|Akithisia at 0 to 120 Min||0 to 120 min after receiving medication|||no. participants exp akathisia|||Number
755919|NCT00590317|Secondary|Nausea at 0 to 120 Min|100mm Visual Analog scale (VAS) Scale is from 0 mm to 100 mm 0mm = no nausea 100mm = severe nausea|0 to 120 minutes after receiving medication|||units on a scale||Standard Deviation|Geometric Mean
755920|NCT00590317|Primary|Vomiting at 0 to 120 Min.||0 to 120 minutes after receiving medication|Convenience sample||number of participants exp vomiting|||Number
755921|NCT00590369|Secondary|Patient Reported Pain|scale of 0= no pain to 10= worst pain possible|at first dressing change; generally 48 hours|||units on a scale||Standard Deviation|Mean
755922|NCT00590369|Secondary|Nursing Time||hospital stay; generally 6 days|||minutes||Standard Deviation|Mean
755923|NCT00590369|Secondary|Cost of Wound Care|cost of device/supplies used in application and dressing changes|during hospital stay; generally 6 days|||dollars (USD)||Standard Deviation|Mean
755924|NCT00590369|Secondary|Ease of Providing Nursing Care|nurse perception of ease of providing nursing care using a Likert-type scale; 5 items assessed. Responses to 1 item provided: Overall experience with nursing care issues related to the wound device. score range is 0, always very difficult, always a problem or not possible to 10, always easy, never or rarely a problem|during hospital stay; generally 6 days|||scores on a scale||Inter-Quartile Range|Median
755925|NCT00590369|Secondary|Ease of Performing Dressing Change|responses to questions using a Likert scale regarding ease of dressing change; 8 characteristics; only reported is: Apply/fasten occlusive drape to secure drainage tube; scale range is 0, very difficult to do, takes a lot of time or effort or not possible to 10, simple or very easy to do|during hospital stay; generally 6 days|||scores on a scale||Inter-Quartile Range|Median
755926|NCT00590369|Primary|5 Measures of Wound Healing: Length, Width, Depth, Undermining, Tunneling|differences in wound healing rate at first dressing between devices; since 5 variables were assessed via a centimeter ruler|first dressing change; typically within 48 hours|||centimeters||Inter-Quartile Range|Median
755927|NCT00590460|Secondary|Number of Patients With Grade III - IV Acute GVHD|"Graft versus Host Disease is when the new stem cells (graft) recognize that the body tissues of the patient (host) are different from those of the donor. When this happens, cells in the graft may attack the host organs, primarily the skin, the liver and the intestines.
The grades of Graft versus Host disease are based on how much the patient's body is damaged by the stem cells attacking the organs. In general the grading ranges from grade I (minor) to grade IV (severe)."|100|||participants|||Number
755928|NCT00590460|Secondary|Number of Patients With Extensive Chronic GVHD From Day 100 to 365|"Graft versus Host Disease is when the new stem cells (graft) recognize that the body tissues of the patient (host) are different from those of the donor. When this happens, cells in the graft may attack the host organs, primarily the skin, the liver and the intestines.
Chronic GVHD usually occurs later than acute GVHD. It usually occurs at least one year after the transplant. Extensive chronic GVHD is when the damage is more extensive to the body."|365 days|||participants|||Number
755929|NCT00590460|Secondary|Number of Patients With Limited Chronic GVHD From Day 100 to 365|"Graft versus Host Disease is when the new stem cells (graft) recognize that the body tissues of the patient (host) are different from those of the donor. When this happens, cells in the graft may attack the host organs, primarily the skin, the liver and the intestines.
Chronic GVHD usually occurs later than acute GVHD. It usually occurs at least one year after the transplant. Limited chronic GVHD is when the damage is less extensive to the body."|365 days|||participants|||Number
755930|NCT00590460|Secondary|Number of Patients Alive at 1 Year Post Transplant||1 year|||participants|||Number
755950|NCT00590590|Secondary|Change From Baseline in Marinoff Dyspareunia Scale Score at End of Treatment (12 Weeks)|0-3 scale with 0=no dyspareunia and 3= completely prevents intercourse|Baseline -12 Weeks|||Score||Standard Error|Mean
755931|NCT00590460|Secondary|Number of Patients With Grade II - IV Acute Graft Versus Host Disease (GVHD)|"Graft versus Host Disease is when the new stem cells (graft) recognize that the body tissues of the patient (host) are different from those of the donor. When this happens, cells in the graft may attack the host organs, primarily the skin, the liver and the intestines.
The grades of Graft versus Host disease are based on how much the patient's body is damaged by the stem cells attacking the organs. In general the grading ranges from grade I (minor) to grade IV (severe)."|100 days|||participants|||Number
755932|NCT00590460|Secondary|Days to Platelet Count of 20,000/mm3 Without Transfusions||30 Days||||||
755933|NCT00590460|Secondary|Days to Absolute Neutrophil Count (ANC) of 500/mm3||30 Days|||days||Full Range|Median
755934|NCT00590460|Secondary|Number of Patients With Treated Related Death||100 days|||participants|||Number
755935|NCT00590460|Secondary|Number of Patients With Graft Failure||100 days|||participants|||Number
755936|NCT00590460|Primary|Number of Patients With Donor Engraftment||100 Days|||participants|||Number
755937|NCT00590538|Secondary|Number of Participants With Abnormal Laboratory Safety Tests|Outcome measure will be obtained by completion of routine metabolic and hematological laboratory parameters for every participant. Metabolic testing willl include a CMP (comprehensive metabolic panel, ALT (alanine aminotransferase test), GGT (gamma-glutamyl transpeptidase), and Uric Acid; Hematological testing will include a complete blood count (CBC), and partial thromboplastin (PT/PTT).|up to 2 weeks|No analysis was completed on data collected; More clinically efficacious compounds have been identified which suggested that completion of this study might not be as critical as when initially proposed; therefore, the study was terminated by PI.||participants|||Number
755938|NCT00590538|Secondary|Number of Participants With Adverse Events|Adverse Events will be assessed and outcome measure obtained by completion of Interval history, physical and mental status examinations of every participant.|up to 2 weeks|||participants|||Number
755939|NCT00590538|Secondary|Change in FVC (Forced Vital Capacity)in Spirometry.|Outcome measure will be obtained from standard Pulmonary Function testing.|baseline and 2 weeks|No analysis was completed on data collected.||Liters|||Number
755940|NCT00590538|Secondary|Change in FEV1 (Forced Expiratory Volume in 1 Second) in Spirometry.|Outcome measure will be obtained from standard Pulmonary Function testing.|baseline and 2 weeks|No analysis was completed on data collected.||Liters|||Number
755941|NCT00590538|Primary|Change in Voltage (mVolt) in Nasal Epithelium|"The basis of analysis for the primary outcome measure will be the comparison of data from both the standard CF Nasal Potential Difference (NPD) Protocol compared to a modified NPD protocol including the perfusion of Genistein.
The NPD response will be compared from baseline to after study drug. NPD responses will then be compared between the Phenylbutrate group and the placebo group."|Baseline and 2 weeks|No analysis was completed on data collected; AND study was never unblinded therefore details not available.||mVolts|||Number
755942|NCT00590564|Primary|To Determine the Effects of Sho-saiko-to on Hepatic Injury in Patients With Chronic Hepatitis C Who Are Intolerant or Have a Specific Contraindication to Interferon-based Therapy.|Response is determined by improvement of 2 points or greater as per Knodell's histology activity index (HAI) scores in paired comparisons of pre and post liver biopsy|52 weeks|||participants|||Number
755943|NCT00590577|Secondary|Change in Clinical Global Impression-Severity (CGI-S) Scores From Baseline to Week 13 or the Last Post-baseline Assessment|The CGI-S rating scale was used to assess the severity of a subject’s overall clinical condition. Scores range from 1 to 7, where 1=best and 7=worst. The change in CGI-S score for all eligible subjects was measured from the beginning of the study to Week 13 (i.e., the end of the double-blind treatment period) or, if the subject left the study early, from the beginning of the study to the last assessment after baseline.|Baseline to 13 weeks or the last post-baseline assessment|The secondary outcome measures used the intent-to-treat analysis set, which consisted of all enrolled subjects who got at least 1 dose of paliperidone palmitate and had both a baseline and at least 1 post-baseline efficacy measurement during the study. For imputation of missing time points, last observation carried forward (LOCF) was used.||Scores on a scale||Full Range|Median
755944|NCT00590577|Secondary|Change in Personal and Social Performance Scale (PSP) Score From Baseline to Week 13 or the Last Post-baseline Assessment.|The PSP scale measures the degree of normal function of a subject in interpersonal relationships and social interactions. Scores range from 1 to 100, where 1 is worst and 100 is best. The average change in PSP score for all eligible subjects was measured from the beginning of the study to Week 13 (i.e., the end of the double-blind treatment period) or, if the subject left the study early, from the beginning of the study to the last assessment after baseline.|Baseline to 13 weeks or the last post-baseline assessment|The secondary outcome measures used the intent-to-treat analysis set, which consisted of all enrolled subjects who got at least 1 dose of paliperidone palmitate and had both a baseline and at least 1 post-baseline efficacy measurement during the study. For imputation of missing time points, last observation carried forward (LOCF) was used.||Scores on a scale||Standard Deviation|Mean
755945|NCT00590577|Primary|Change in Positive and Negative Syndrome Scale (PANSS) Total Score From Baseline to Week 13 or the Last Post-baseline Assessment|The PANSS measures the severity of psychotic symptoms of schizophrenia. Scores range from 30 to 210, where 30=best and 210=worst. The change in PANSS total score for all eligible subjects was measured from the beginning of the study to Week 13 (i.e., the end of the double-blind treatment period) or, if the subject left the study early, from the beginning of the study to the last assessment after baseline.|Baseline to 13 weeks or the last post-baseline assessment|The primary outcome measure used the intent-to-treat analysis set, which consisted of all enrolled subjects who got at least 1 dose of paliperidone palmitate and had both a baseline and at least 1 post-baseline efficacy measurement during the study. For imputation of missing time points, last observation carried forward (LOCF) was used.||Scores on a scale||Standard Deviation|Mean
755946|NCT00590590|Secondary|Change From Baseline in Tenderness (on a 0- to 3-point Scale) on Palpation at End of Treatment (12 Weeks) [Scale Rates the Severity of Pain; 0 =Absent and 3 = Severe]||12 Weeks|||Score||Standard Error|Mean
755947|NCT00590590|Secondary|Change From Baseline in Overall Vulvar Vestibulitis Symptoms Visual Analog Scale (VAS) Score at End of Treatment (12 Weeks) [0 = No Symptoms and 100 = As Bad as They Can be]||12 Weeks|||Score||Standard Error|Mean
755948|NCT00590590|Secondary|Change From Baseline in Overall Intercourse-Related Pain Visual Analog Scale (VAS) Score at End of Treatment (12 Weeks) [0 = No Pain and 100 = Most Severe Pain]||12 weeks|||Score||Standard Error|Mean
755951|NCT00590590|Primary|Mean Marinoff Dyspareunia Scale Score (MDSS) at End of Treatment (12 Weeks)|The MDSS consists of a participant rating of their dyspareunia (painful sexual intercourse) on a 0- to 3-point scale. Each numerical value on the scale coincides with a level of pain experienced during sexual intercourse; 0 = no dyspareunia (no pain with intercourse) and 3 = completely prevents intercourse|12 weeks|||scores on a scale||Standard Error|Mean
755952|NCT00590720|Secondary|Accumulation Index|Ratio of trough concentrations after first (Day 0) and last (Day 24) dose of MEDI-528|Days 0 and 24|All participants who received at least one dose of MEDI-528 (n=7) and had available data (n=5).||Ratio||Standard Deviation|Mean
755953|NCT00590720|Secondary|Half-life (T1/2)|T1/2 of MEDI-528|Days 0, 3, 7, 10, 14, 17, 21, 24, 28, 32, 37, 42, 56, 70, 84, 119, and 150|All participants who received at least one dose of MEDI-528.||Day||Standard Deviation|Mean
755954|NCT00590720|Secondary|Mean Trough Concentration at Last Measurable Time Point (Cmin_last)|Cmin_last of MEDI-528|Days 0, 3, 7, 10, 14, 17, 21, 24, 28, 32, 37, 42, 56, 70, 84, 119, and 150|All participants who received at least one dose of MEDI-528.||Microgram per milliliter||Standard Deviation|Mean
755955|NCT00590720|Secondary|Mean Trough Concentration (Cmin)|Cmin of MEDI-528|Days 0, 3, 7, 10, 14, 17, 21, 24, 28, 32, 37, 42, 56, 70, 84, 119, and 150|All participants who received at least one dose of MEDI-528.||Microgram per milliliter||Standard Deviation|Mean
755956|NCT00590720|Secondary|Time to Return in Minutes to 90 Percent of Baseline Forced Expiratory Volume in 1 Second (FEV1)|Time to return in minutes to 90 percent of baseline FEV1 (prior to exercise) after exercise on Day 150|Day 150 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)|All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and had available data (n=8, 2 placebo and 6 MEDI-528).||Minutes||Standard Deviation|Mean
755957|NCT00590720|Secondary|Time to Return in Minutes to 90 Percent of Baseline Forced Expiratory Volume in 1 Second (FEV1)|Time to return in minutes to 90 percent of baseline FEV1 (prior to exercise) after exercise on Day 56|Day 56 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)|All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and had available data (n=8, 2 placebo and 6 MEDI-528).||Minutes||Standard Deviation|Mean
755958|NCT00590720|Secondary|Time to Return in Minutes to 90 Percent of Baseline Forced Expiratory Volume in 1 Second (FEV1)|Time to return in minutes to 90 percent of baseline FEV1 (prior to exercise) after 30 minues of exercise on Day 28|Day 28 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)|All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and had available data (n=9, 2 placebo and 7 MEDI-528).||Minutes||Standard Deviation|Mean
755959|NCT00590720|Secondary|Area Under the Curve (AUC) of Forced Expiratory Volume in 1 Second (FEV1)|AUC of FEV1 at Day 150|Day 150 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)|All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and had available data (n=7, 2 placebo and 5 MEDI-528).||Liter x min||Standard Deviation|Mean
755960|NCT00590720|Secondary|Area Under the Curve (AUC) of Forced Expiratory Volume in 1 Second (FEV1)|AUC of FEV1 at Day 56|Day 56 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)|All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and had available data (n=7, 2 placebo and 5 MEDI-528).||Liter x min||Standard Deviation|Mean
755961|NCT00590720|Secondary|Area Under the Curve (AUC) of Forced Expiratory Volume in 1 Second (FEV1)|AUC of FEV1 at Day 28|Day 28 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)|All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and had available data (n=8, 2 placebo and 6 MEDI-528).||Liter x min||Standard Deviation|Mean
755962|NCT00590720|Secondary|Percent Maximum Change in Forced Expiratory Volume in 1 Second (FEV1)|The clinical activity of MEDI-528 on exercise-induced bronchoconstriction was measured by exercise challenge testing expressed as the percent maximum change in FEV1 before and after exercise on Day 150.|Day 150 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)|All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and had available data (n=8, 2 placebo and 6 MEDI-528).||Percent change||Standard Deviation|Mean
755963|NCT00590720|Secondary|Percent Maximum Change in Forced Expiratory Volume in 1 Second (FEV1)|The clinical activity of MEDI-528 on exercise-induced bronchoconstriction was measured by exercise challenge testing expressed as the percent maximum change in FEV1 before and after exercise on Day 56.|Day 56 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)|All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and had available data (n=8, 2 placebo and 6 MEDI-528).||Percent change||Standard Deviation|Mean
755964|NCT00590720|Secondary|Percent Maximum Change in Forced Expiratory Volume in 1 Second (FEV1)|The clinical activity of MEDI-528 on exercise-induced bronchoconstriction was measured by exercise challenge testing expressed as the percent maximum change in FEV1 before and after exercise on Day 28.|Day 28 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)|All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and performed acceptable spirometry (n=9, 2 placebo and 7 MEDI-528).||Percent change||Standard Deviation|Mean
755965|NCT00590720|Secondary|Absolute Maximum Change in Forced Expiratory Volume in 1 Second (FEV1)|The clinical activity of MEDI-528 on exercise-induced bronchoconstriction was measured by exercise challenge testing expressed as the maximum change in FEV1 before and after exercise on Day 150.|Day 150 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)|All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and had available data (n=8, 2 placebo and 6 MEDI-528).||Liter||Standard Deviation|Mean
755966|NCT00590720|Secondary|Absolute Maximum Change in Forced Expiratory Volume in 1 Second (FEV1)|The clinical activity of MEDI-528 on exercise-induced bronchoconstriction was measured by exercise challenge testing expressed as the maximum change in FEV1 before and after exercise on Day 56.|Day 56 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)|All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and had available data (n=8, 2 placebo and 6 MEDI-528).||Liter||Standard Deviation|Mean
755967|NCT00590720|Secondary|Absolute Maximum Change in Forced Expiratory Volume in 1 Second (FEV1)|The clinical activity of MEDI-528 on exercise-induced bronchoconstriction was measured by exercise challenge testing expressed as the maximum change in FEV1 measured before and after exercising on Day 28.|Day 28 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)|All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and performed acceptable spirometry (n=9, with 2 placebo and 7 MEDI-528).||Liter||Standard Deviation|Mean
755968|NCT00590720|Secondary|Incidence of Anti-drug Antibodies (ADA) to MEDI-528|Number of participants with ADA to MEDI-528|Days 0, 28, 56, 119, and 150|All participants who received at least one dose of MEDI-528.||Participants|||Number
755969|NCT00590720|Primary|Incidence of Serious Adverse Events|Number of participants experiencing serious adverse events|Days 0 - 150|All participants who received at least one dose of investigational product (MEDI-528 or placebo).||Participants|||Number
755970|NCT00590720|Primary|Incidence of Adverse Events|Number of participants experiencing adverse events (includes both adverse events and serious adverse events)|Days 0 - 150|All participants who received at least one dose of investigational product (MEDI-528 or placebo).||Participants|||Number
755971|NCT00590759|Secondary|A Subset of Major Adverse Events Will be Evaluated in Subjects Treated With the TAG Device and Subjects Treated With Open Surgical Repair.|Proportion of subjects in TAG 05-02 with MAEs|5 years|||participants|||Number
755972|NCT00590759|Primary|Aneurysm Related Death|Freedom from aneurysm related mortality for TAG 05-02 subjects|5 years|||participants|||Number
755973|NCT00590772|Primary|Change From Baseline in Fatigue and Daytime Sleepiness at 2 Weeks|"Daytime sleepiness was assessed on a scale of 0 (none) to 4 with 4 being severe.
To determine improvement of daytime sleepiness with active therapy we used a scale of 0 to 4 with 0 being no improvement and 4 being maximal improvement.
To determine improvement of daytime fatigue with active therapy we used a scale of 0 to 4 with 0 being no improvement and 4 being significant improvement.
For all three above we used data from the last 3 days were averaged and mean of change for each day."|baseline and 2 weeks|||units on a scale||Standard Deviation|Mean
755974|NCT00590863|Secondary|Quality of Life Inventory|The Quality of Life Inventory (QOLI) is a 32-item comprehensive self-report of satisfaction in 16 areas of life, such as love, work, and health. Each area is rated in terms of satisfaction and the relationship of that area to overall quality of life. It yields an overall raw score and satisfaction ratings for the 16 individual areas of life. The QOLI raw score is an average of weighted satisfaction ratings computed only over areas of life judged to be Important or Extremely Important to the respondent. Higher scores indicate higher reported quality of life.|Measured at Month 7|||units on a scale||Standard Deviation|Mean
755975|NCT00590863|Primary|Quick Inventory of Depressive Symptoms|Percentage of patients that achieve remission, as defined as QIDS total score below 6 for last 2 study visits. QIDS depression scores range from 0 (normal) to 27 (very severe).|Measured at Month 7|Remission = Last 2 QIDS < 6. A chi-square test was used to compare the remission rates across the treatment groups. The Fisher's exact test was used when expected cell frequencies were <5. For binary outcomes (e.g., remission), bivariate logistic regression models were fit to estimate the effect of treatment on outcome.||percentage of participants|||Number
755976|NCT00590889|Primary|Incidence of Prosthetic Valve Endocarditis Comparing Conventional Valves to Silzone™ Coated Valves.|Patient response to treatment with the Silzone™ treated valve will be evaluated based upon the incidence of early and late PVE (prosthetic valve endocarditis) in the treatment group vs. the control group.|1 year|subjects randomized into the study||participants|||Number
755977|NCT00590902|Primary|Overall Objective Response of OSI-774|(complete and partial responses) Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee.|53 weeks|||participants|||Number
755978|NCT00590967|Secondary|Efficacy of IMRT to the Para-aortic Lymph Nodes, IMRT External Beam Radiotherapy to the Pelvis, Intracavitary Irradiation, and Cisplatin Chemotherapy as Measured by the Frequency of Distant Metastasis||5 years after completion of radiation therapy|The data was not collected for this secondary outcome. Due to the the early termination of this study, only data for the primary outcomes were collected and analyzed.|||||
755979|NCT00590967|Primary|Efficacy of IMRT Extended-field Radiation Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy as Measured by PET Scan Disease Status||1st PET scan after completion of treatment (approximately month 6)|||participants|||Number
755980|NCT00590967|Primary|Number of Participants With Acute Toxicity of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy (Grade 3 or Higher)||30 days after completion of radiation therapy|||participants|||Number
755981|NCT00590967|Primary|Tolerance of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy as Measured the Number of Participants With by Grade 4 or Higher Toxicity|-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for all toxicity reporting.|1 year post start of radiation therapy|||participants|||Number
755982|NCT00591006|Secondary|Para-Hippocampal Activation Differences Between Treatment Conditions||At the end of each treatment condition|||percentage of BOLD activation||Standard Deviation|Mean
755983|NCT00591006|Secondary|Hippocampal Activation Differences Between Treatment Conditions||At the end of each treatment condition|||percentage of BOLD activation||Standard Deviation|Mean
755984|NCT00591006|Primary|Difference in RAVLT Total T-Score Between Treatments|The Rey Auditory Verbal Learning Test (RAVLT) evaluates a wide diversity of functions, including short-term auditory-verbal memory, and retention of information. Test raw scores are converted to T-scores. T-scores have a mean of 30 ± 10 where higher scores are indicative of better verbal memory. Total T-score differences following study treatment interventions are reported.|At end of each treatment condition (on average 21 days between treatments)|||T-score||Standard Error|Mean
755985|NCT00591019|Secondary|Simple Reaction Time (Attention)for Baseline, Modafinil and Placebo Arms.|Simple reaction time to an auditory signal is a measure of attention.|5 weeks|||milli seconds||Standard Error|Mean
755986|NCT00591019|Primary|The P50 Amplitude (i.e. Evoked Auditory Response Potential Recorded in Millivolts 50 Milliseconds After Sound Onset).|P50 is an auditory evoked response potential sensitive to states of arousal.|5 weeks|||milli volts||Standard Error|Mean
755987|NCT00591149|Primary|Efficacy Measured by Response Rate in Participants|"Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT and MRI:
Complete Response (CR), Disappearance of all target lesions;
Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions;
Stable Disease (NR/SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of the longest diameter since the treatment started;
Progressive Disease (PD), A 20% or greater increase in the sum of the longest diameter of measured lesions (target lesions), taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions."|12 Weeks, 1 Year|||participants|||Number
755988|NCT00591214|Secondary|Change in HCV RNA Levels of MP-424|"Date were collected at Day -28, Day1 (0 (pre-dose), 2.5, 4, 8, 16 hours post-dose), Day2, Day3, Day8, Day14, Day29, Day43, Day57, Day86.
Change Value was calculated as the each time point minus the baseline point which was averaged Day -28 and Day0-0hour(pre-dose))."|Day1 (2.5, 4, 8, 16 hours), Day2, Day3, Day8, Day14, Day29, Day43, Day57 and Day86|||Log IU / mL||Standard Deviation|Mean
755989|NCT00591214|Primary|t1/2 (Half Life Period) of MP-424|Date were collected at Day1 (0 (pre-dose), 1 ,2.5, 4, 6, 8, 12, 16 hours post-dose), Day14 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16 hours post-dose) and Day85 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16, 24 hours post-dose). Date as pre-dose were collected at Day2, Day3, Day8, Day15, Day29, Day43 and Day57.|Date were collected at Day1 to Day85|||hours||Standard Deviation|Mean
755990|NCT00591214|Primary|Ctrough (Plasma Trough Concentration) of MP-424|Date were collected at Day1 (0 (pre-dose), 1 ,2.5, 4, 6, 8, 12, 16 hours post-dose), Day14 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16 hours post-dose) and Day85 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16, 24 hours post-dose). Date as pre-dose were collected at Day2, Day3, Day8, Day15, Day29, Day43 and Day57.|Date were collected at Day1 to Day85|||μg/mL||Standard Deviation|Mean
755991|NCT00591214|Primary|AUC 0-8h (Area Under the Concentration-time Curve From Time Zero to 8 Hours) of MP-424|Date were collected at Day1 (0 (pre-dose), 1 ,2.5, 4, 6, 8, 12, 16 hours post-dose), Day14 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16 hours post-dose) and Day85 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16, 24 hours post-dose). Date as pre-dose were collected at Day2, Day3, Day8, Day15, Day29, Day43 and Day57.|Date were collected at Day1 to Day85|||μg x h /mL||Standard Deviation|Mean
755992|NCT00591214|Primary|Tmax (Time of Maximum Plasma Concentration) of MP-424|Date were collected at Day1 (0 (pre-dose), 1 ,2.5, 4, 6, 8, 12, 16 hours post-dose), Day14 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16 hours post-dose) and Day85 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16, 24 hours post-dose). Date as pre-dose were collected at Day2, Day3, Day8, Day15, Day29, Day43 and Day57.|Date were collected at Day1 to Day85|||hours||Full Range|Median
755993|NCT00591214|Primary|Cmax (Maximum Observed Concentration in Plasma) of MP-424|Date were collected at Day1 (0 (pre-dose), 1 ,2.5, 4, 6, 8, 12, 16 hours post-dose), Day14 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16 hours post-dose) and Day85 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16, 24 hours post-dose). Date as pre-dose were collected at Day2, Day3, Day8, Day15, Day29, Day43 and Day57.|Date were collected at Day1 to Day85|||μg / mL||Standard Deviation|Mean
755994|NCT00591227|Primary|Hospital Length of Stay|hospital length of stay in days|days|||days||95% Confidence Interval|Mean
755995|NCT00591227|Secondary|Frequency of Hypoglycemia During Emergency Room Therapy With Insulin||from emergency room admission to discharge||||||
755996|NCT00591227|Secondary|Efficacy of Blood Glucose Lowering During the Emergency Room Stay||from emergency room admission to discharge||||||
755997|NCT00591227|Secondary|Frequency of Hypoglycemia||from hospital admission to discharge||||||
755998|NCT00591227|Secondary|Average Blood Glucose During the Hospital Admission||from admission to discharge||||||
755999|NCT00591227|Primary|Length of Stay in the Hospital||from hospital admission to hospital discharge||||||
756000|NCT00591240|Primary|Clinical Validation of Biosensor Assays Used for Pathogen Identification and Antimicrobial Susceptibility Testing in Patients at Risk of Urinary Tract Infections.|"Study 1: Multiplex pathogen identification using biosensor based assay. We recruited 116 participants yielding 109 urine samples suitable for analysis and comparison between biosensor assays and standard urine culture. Biosensor based assays were used to detect multiple pathogens in the urine samples.
Study 2: Antimicrobial susceptibility testing using biosensor based assay. We recruited 222 participants yielding 252 urine samples. Corresponding biosensor and clinical microbiology culture data was available for 215 samples. 73% (157) of these samples contained bacteria. Biosensor based antimicrobial susceptibility test, in concert with pathogen identification assay was directly performed on these samples."|Up to 1.5 years|Urine samples were collected from participants at the Spinal Cord Injury Service for assay validation.||percentage of urine specimen|Participants||Number
756001|NCT00591253|Secondary|Percentage of Participants Who Achieve Both a Clinic Diastolic and Systolic Blood Pressure Response|Percentage of participants who achieve both a clinic diastolic and systolic blood pressure response measured at week 6, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg AND less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Diastolic and systolic blood pressure is based on the arithmetic mean of the 3 sitting blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.||percentage of participants|||Number
756002|NCT00591253|Secondary|Percentage of Participants Who Achieve a Clinic Diastolic Blood Pressure Response, Defined as < 90 mm Hg and/or Reduction From Baseline ≥ 10 mm Hg|Percentage of participants who achieve a clinic diastolic blood pressure response measured at week 6, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg. Diastolic blood pressure is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.||percentage of participants|||Number
756003|NCT00591253|Secondary|Percentage of Participants Who Achieve a Clinic Systolic Blood Pressure Response, Defined as < 140 mm Hg and/or Reduction From Baseline ≥ 20 mm Hg|Percentage of participants who achieve a clinic systolic blood pressure response measured at week 6, defined as less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.||percentage of participants|||Number
756033|NCT00591305|Primary|Number of Cases With Recurrence of Laryngeal Papilloma in 5 Months|vocal lesion size and area after 5 month with surgery visible lesion found in >50% of the treated tissue area, after surgery|Recurrence of pailloma at 5 months|participants received at least one of two interventions||case|||Number
756004|NCT00591253|Secondary|Change From Baseline in the Trough (22-24-hr) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
756005|NCT00591253|Secondary|Change From Baseline in the Trough (22-24-hr) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
756006|NCT00591253|Secondary|Change From Baseline in the 12-hr Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 12-hour mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
756007|NCT00591253|Secondary|Change From Baseline in the 12-hr Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 12-hour mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
756008|NCT00591253|Secondary|Change From Baseline in the Nighttime (12 am to 6 am) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
756009|NCT00591253|Secondary|Change From Baseline in the Nighttime (12 am to 6 am) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
756010|NCT00591253|Secondary|Change From Baseline in Daytime (6am to 10 pm) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
756011|NCT00591253|Secondary|Change From Baseline in Daytime (6am to 10 pm) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
756012|NCT00591253|Secondary|Change From Baseline in Mean Trough Clinic Sitting Diastolic Blood Pressure|The change in mean trough clinic sitting diastolic blood pressure measured at final visit or week 6 relative to baseline.|Baseline and Week 6.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
756013|NCT00591253|Secondary|Change From Baseline in the 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
756014|NCT00591253|Secondary|Change From Baseline in Mean Trough Clinic Sitting Systolic Blood Pressure|The change in mean trough clinic sitting systolic blood pressure measured at final visit or week 6 relative to baseline.|Baseline and Week 6.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
756015|NCT00591253|Primary|Change From Baseline in the 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
756016|NCT00591266|Secondary|Percentage of Participants Who Achieve Both a Clinic Diastolic and Systolic Blood Pressure Response|Percentage of participants who achieve both a clinic diastolic and systolic blood pressure response measured at week 6 relative to baseline, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg AND less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Diastolic and systolic blood pressure is based on the arithmetic mean of the 3 sitting blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.||percentage of participants|||Number
756017|NCT00591266|Secondary|Percentage of Participants Who Achieve a Clinic Diastolic Blood Pressure Response, Defined as < 90 mm Hg and/or Reduction From Baseline ≥ 10 mm Hg|Percentage of participants who achieve a clinic diastolic blood pressure response measured at week 6 relative to baseline, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg. Diastolic blood pressure is the arithmetic mean of 3 trough sitting diastolic blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.||percentage of participants|||Number
756034|NCT00591344|Secondary|5 Time Sit to Stand|The time it takes to stand up and sit down five times|Obtained during initial evaluation & then every 6 six months to end of 2-yr training period||||||
756018|NCT00591266|Secondary|Percentage of Participants Who Achieve a Clinic Systolic Blood Pressure Response, Defined as < 140 mm Hg and/or Reduction From Baseline ≥ 20 mm Hg|Percentage of participants who achieve a clinic systolic blood pressure response measured at week 6 relative to baseline, defined as less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.||percentage of participants|||Number
756019|NCT00591266|Secondary|Change From Baseline in the Trough (22-24-hr) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
756020|NCT00591266|Secondary|Change From Baseline in the Trough (22-24-hr) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
756021|NCT00591266|Secondary|Change From Baseline in the 12-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring|The change in the 12-hour mean diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
756022|NCT00591266|Secondary|Change From Baseline in the 12-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring|The change in the 12-hour mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
756023|NCT00591266|Secondary|Change From Baseline in the Nighttime (12 am to 6 am) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
756024|NCT00591266|Secondary|Change From Baseline in the Nighttime (12 am to 6 am) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
756025|NCT00591266|Secondary|Change From Baseline in Daytime (6am to 10 pm) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
756026|NCT00591266|Secondary|Change From Baseline in Daytime (6am to 10 pm) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
756027|NCT00591266|Secondary|Change From Baseline in Mean Trough Clinic Sitting Diastolic Blood Pressure|The change in mean trough clinic sitting diastolic blood pressure measured at final visit or week 6 relative to baseline. Diastolic blood pressure is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
756028|NCT00591266|Secondary|Change From Baseline in the 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
756029|NCT00591266|Secondary|Change From Baseline in Mean Trough Clinic Sitting Systolic Blood Pressure.|The change in mean trough clinic sitting systolic blood pressure measured at final visit or week 6 relative to baseline. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
756030|NCT00591266|Primary|Change From Baseline in the 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
756031|NCT00591305|Secondary|Estradiol Level in Blood Post Treatment|determine side-effect by comparing Estradiol level in blood before and after treatment|5 month|failure for any meaningful analysis as only 1 participant in this study||pg/ml|||Number
756032|NCT00591305|Secondary|Estradiol Level in Blood Pre Treatment|determine side-effect by comparing Estradiol level in blood before and after treatment|Before treatment at baseline|failure for any meaningful analysis as only 1 participant in this study||pg/ml|||Number
756048|NCT00591344|Secondary|Spatiotemporal Gait Analysis|Spatiotemporal gait analysis using a pressure sensitive walk way allow for measurement of gait velocity, step length, single and double limb support time, cadence, ect.|obtained during initial evaluation & then every 6 six months to end of 2-yr training period||||||
756049|NCT00591344|Secondary|Rise Time|This is the time is takes for an individual to go for rest to a 50% of a MVC contraction as fast as possible.|obtained during initial evaluation & then every 6 six months to end of 2-yr training period||||||
756050|NCT00591344|Secondary|Relaxation Time|Time for a subject to passively relax their muscle after performing and isometric contraction to 50% of their MVC|obtained during initial evaluation & then every 6 six months to end of 2-yr training period||||||
756051|NCT00591344|Secondary|Peak Movement Velocity|This is how fast an individual can perform a 72 degree elbow flexion movement|obtained during initial evaluation & then every 6 six months to end of 2-yr training period||||||
756052|NCT00591344|Secondary|Time to Peak Velocity|Time of the onset of the movement to peak velocity.|obtained during initial evaluation & then every 6 six months to end of 2-yr training period||||||
756053|NCT00591344|Secondary|Qant|The integral of the antagonist EMG signal from the onset of the agonist EMG to the end of the movement|obtained during initial evaluation & then every 6 six months to end of 2-yr training period||||||
756054|NCT00591344|Secondary|Co-contraction During Limb Acceleration|the amount of agonist and antagonist activity present during limb acceleration.|Obtained during initial evaluation & then every 6 six months to end of 2-yr training period||||||
756055|NCT00591344|Secondary|Number of Agonist Bursts|This is the number of agonist bursts prior to peak velocity.|obtained during initial evaluation & then every 6 six months to end of 2-yr training period||||||
756056|NCT00591344|Secondary|Duration of First Agonist Burst|Time in (ms) for the duration of the first agonist burst during a 72 degree elbow flexion movement and also the percentage of agonist EMG bursts until peak velocity|obtained during initial evaluation & then every 6 six months to end of 2-yr training period||||||
756057|NCT00591344|Secondary|Magnitude of the Agonist Burst|Magnitude of the agonist burst reflects the amount of agonist activation during movement.|obtained during initial evaluation & then every 6 six months to end of 2-yr training period||||||
756058|NCT00591344|Secondary|Magnitude of the Antagonist Burst|the area under the rectified antagonist signal form agonist EMG onset until the end of movement. This reflects the amount of antagonist activation during movement.|obtained during initial evaluation & then every 6 six months to end of 2-yr training period||||||
756059|NCT00591344|Secondary|Magnitude of the First 30 ms of the Agonist Burst|The integral of the first 30 msec of the agonist EMG.|obtained during initial evaluation & then every 6 six months to end of 2-yr training period||||||
756060|NCT00591344|Secondary|The Integral of the First Agonist Burst|The Integral of the first agonist EMG signal from onset of the agonist EMG signal until peak velocity|obtained during initial evaluation & then every 6 six months to end of 2-yr training period||||||
756061|NCT00591344|Secondary|Percentage of Agonist EMG Signal Contained in the 0-5, 5-15, 15-30, and 35-50 Hz Frequency Bins During Isometric Contractions|This is a measure of the percentage of the EMG signal that is contained in different frequency bins during a MVC (elbow flexion/extension; ankle DF/PF), a 50% of MVC elbow fleixon contraction, and a 5 NM elbow flexion contraction.|obtained during initial evaluation & then every 6 six months to end of 2-yr training period||||||
756062|NCT00591344|Secondary|Ankle Dorsiflexion Strength|This is a measure of the MVC for ankle dorsiflexion|obtained during initial evaluation & then every 6 six months to end of 2-yr training period||||||
756063|NCT00591344|Secondary|Elbow Extension Strength|This is a measure of the MVC for elbow extension|obtained during initial evaluation & then every 6 six months to end of 2-yr training period||||||
756064|NCT00591344|Secondary|Ankle Plantar Flexion Strength|This is a measure of the MVC for ankle plantar flexion strength|obtained during initial evaluation & then every 6 six months to end of 2-yr training period||||||
756065|NCT00591344|Secondary|Elbow Flexion Strength|This is the MVC for elbow flexion|obtained during initial evaluation & then every 6 six months to end of 2-yr training period||||||
756066|NCT00591344|Secondary|L-dopa equivalent-mg/Day|This was the equivalent amount of dopamine (mg/day) each subject was prescribed based upon all of their PD medications.|obtained during initial evaluation & then every 6 six months to end of 2-yr training period|||mg/day||Standard Deviation|Mean
756067|NCT00591344|Secondary|On Medication UPDRS-III|UPDRS part III, is an observer rated clinical measure of motor signs of PD. It is used as a measure of severity of motor signs. We measured this at baseline, 6 , 18 and 24 months. This is a ordinal scale of 0-4 which has 27 items which measures slowness of movement (Bradykinesia), Tremor, Rigidity (muscle stiffness) and postural instabilty. The total value for the UPDRS part III scale which ranges from 0 to 108, with a larger number indicating a higher level of impairment.|obtained during initial evaluation & then every 6 six months to end of 2-yr training period|||units on a scale||Standard Deviation|Mean
756068|NCT00591344|Primary|Off Medication UPDRS Part III, Motor Subscale Score|UPDRS part III, is an observer rated clinical measure of motor signs of PD. It is used as a measure of severity of motor signs. We measured this at baseline, 6 , 18 and 24 months. This is a ordinal scale of 0-4 which has 27 items which measures slowness of movement (Bradykinesia), Tremor, Rigidity (muscle stiffness) and postural instabilty. The total value for UPDRS part III scale which ranges from 0 to 108, with a larger number indicating a higher level of impairment.|obtained during initial evaluation & then every 6 six months to end of 2-yr training period|||units on a scale||Standard Deviation|Mean
756069|NCT00591370|Secondary|Duration of Objective Clinical Responses|Duration of Response (Objective Clinical Responses)|24 weeks after ending treatment|||months||Full Range|Median
756070|NCT00591370|Secondary|Overall Survival|Overall survival at 18 months post treatment|18 months after ending treatment|||percentage of participants|||Number
756071|NCT00591370|Primary|Determine the Overall Objective Response Rate (CR and PR).|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|From start of treatment through 24 weeks after ending treatment|||participants|||Number
756072|NCT00591565|Primary|Change From Baseline at 8 Weeks in the HAM-A Scale|this is a validated clinician administered scale that can range from 0-44 (mild to severe illness).|baseline and 8wk|LOCF if two initial visits were completed||units on a scale||Standard Deviation|Mean
756073|NCT00591578|Secondary|Percentage of Participants Who Achieve Both a Clinic Diastolic and Systolic Blood Pressure Response.|Percentage of participants who achieve both a clinic diastolic and systolic blood pressure response measured at week 24, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg AND less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Diastolic and systolic blood pressure is based on the arithmetic mean of the 3 sitting blood pressure measurements.|Baseline and Week 24.|Full analysis set with last observation carried forward.||percentage of participants|||Number
756074|NCT00591578|Secondary|Percentage of Participants Who Achieve a Clinic Diastolic Blood Pressure Response, Defined as < 90 mm Hg and/or Reduction From Baseline ≥ 10 mm Hg.|Percentage of participants who achieve a clinic diastolic blood pressure response measured at week 24, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg. Diastolic blood pressure is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements.|Baseline and Week 24.|Full analysis set with last observation carried forward.||percentage of participants|||Number
756075|NCT00591578|Secondary|Percentage of Participants Who Achieve a Clinic Systolic Blood Pressure Response, Defined as < 140 mm Hg and/or Reduction From Baseline ≥ 20 mm Hg.|Percentage of participants who achieve a clinic systolic blood pressure response measured at week 24, defined as less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.|Baseline and Week 24.|Full analysis set with last observation carried forward.||percentage of participants|||Number
756076|NCT00591578|Secondary|Change From Baseline in the Trough (22-24-hr) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough mean diastolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 24.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
756077|NCT00591578|Secondary|Change From Baseline in the Trough (22-24-hr) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough mean systolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 24.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
756078|NCT00591578|Secondary|Change From Baseline in the 12-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 12-hour mean diastolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 24.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
756079|NCT00591578|Secondary|Change From Baseline in the 12-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 12-hour mean systolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 24.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
756080|NCT00591578|Secondary|Change From Baseline in the Nighttime (12 am to 6 am) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean diastolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 24.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
756081|NCT00591578|Secondary|Change From Baseline in the Nighttime (12 am to 6 am) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean systolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 24.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
756082|NCT00591578|Secondary|Change From Baseline in Daytime (6am to 10 pm) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean systolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 24.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
756083|NCT00591578|Secondary|Change From Baseline in Daytime (6am to 10 pm) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean systolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 24.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
756084|NCT00591578|Secondary|Change From Baseline in Mean Trough Clinic Sitting Diastolic Blood Pressure|The change in mean trough clinic sitting diastolic blood pressure measured at final visit or week 24 relative to baseline. Diastolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.|Baseline and Week 24.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
756085|NCT00591578|Secondary|Change From Baseline in the 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean diastolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 24.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
756086|NCT00591578|Secondary|Change From Baseline in Mean Trough Clinic Sitting Systolic Blood Pressure.|The change in mean trough clinic sitting systolic blood pressure measured at final visit or week 24 relative to baseline. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.|Baseline and Week 24.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
756087|NCT00591578|Primary|Change From Baseline in 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean systolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 24.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
756088|NCT00591591|Secondary|Apnea Hypopnea Index (AHI is the Index of Severity That Combines Apneas and Hypopneas) Determined During the Routine Sleep Study||6 hours of sleep|||Number of apnea/hypopnea per sleep hour||Standard Deviation|Mean
756089|NCT00591591|Primary|Deoxy-Hemoglobin Concentration in the Brain During Sleep||6 hours of sleep|Absolute Brain Oximetry: Quantitative Hemodynamic Responses of Brain During Sleep, in Healthy & OSA Subjects.||µM||Standard Deviation|Mean
756090|NCT00591591|Primary|Total Hemoglobin Concentration in the Brain During Sleep||6 hours of sleep|||µM||Standard Deviation|Mean
756091|NCT00591591|Primary|Oxyhemoglobin Concentration in the Brain During Sleep||6 hours of sleep|Absolute Brain Oximetry: Quantitative Hemodynamic Responses of Brain During Sleep, in Healthy & OSA Subjects.||µM||Standard Deviation|Mean
756092|NCT00591591|Primary|Percentage of Oxygen Saturation in the Brain During Sleep||6 hours of sleep|Absolute Brain Oximetry: Quantitative Hemodynamic Responses of Brain During Sleep, in Healthy & OSA Subjects.||Percentage of brain oxygen saturation||Standard Deviation|Mean
756093|NCT00591721|Primary|Change From Baseline in Subscale Scores of the Fatigue Impact Scale|"Fatigue impact was measured using the Fatigue Impact Scale (FIS) (Fisk et al, 1994). This 40-item scale evaluates the construct of perceived impact of fatigue on everyday life. Respondents rate each statement using a 5-point Likert-type scale ranging from 0 (no problem) to 4 (extreme problem). A total score (range from 0 to 160) and three subscale scores (physical - 10 items, score range 0 to 40; psychosocial - 20 items, score range 0 to 80; cognitive - 10 items, score range 0-40) can be produced from participants’ responses. Higher scores reflect greater fatigue impact. What is reported here is the mean individual differences in the 7 week post subscale scores minus the baseline subscale scores"|baseline, 7 weeks (immediate post-intervention)|Intent-to-treat, imputation by maximum likelihood approach||units on a scale||Standard Deviation|Mean
756094|NCT00591734|Secondary|Objective Response Rate|The percentage of patients who experience an objective benefit from treatment|13 months||||||
756095|NCT00591734|Secondary|Overall Survival|The length of time, in months, that patients were alive from their first date of protocol treatment until death|18 months||||||
756096|NCT00591734|Primary|Progression-free Survival|Length of time, in months, that patients were alive from their first date of protocol treatment until worsening of their disease|13 months|||months||95% Confidence Interval|Median
756097|NCT00591760|Primary|Peak VO2|changes in peak VO2|6 months|||ml/kg/min||Standard Error|Mean
756098|NCT00591773|Secondary|Percentage of Participants Who Achieve Both a Clinic Diastolic and Systolic Blood Pressure Response.|Percentage of participants who achieve both a clinic diastolic and systolic blood pressure response measured at week 6, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg AND less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Diastolic and systolic blood pressure is based on the arithmetic mean of the 3 sitting blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.||percentage of participants|||Number
756099|NCT00591773|Secondary|Percentage of Participants Who Achieve a Clinic Diastolic Blood Pressure Response, Defined as < 90 mm Hg and/or Reduction From Baseline ≥ 10 mm Hg|Percentage of participants who achieve a clinic diastolic blood pressure response measured at week 6 , defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg. Diastolic blood pressure is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.||percentage of participants|||Number
756100|NCT00591773|Secondary|Percentage of Participants Who Achieve a Clinic Systolic Blood Pressure Response, Defined as < 140 mm Hg and/or Reduction From Baseline ≥ 20 mm Hg|Percentage of participants who achieve a clinic systolic blood pressure response measured at week 6, defined as less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.||percentage of participants|||Number
756101|NCT00591773|Secondary|Change From Baseline in the Trough (22-24-hr) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
756102|NCT00591773|Secondary|Change From Baseline in the Trough (22-24-hr) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
756103|NCT00591773|Secondary|Change From Baseline in the 12-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 12-hour mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
756365|NCT00603044|Primary|Number of CD25 Pos/FoxP3 Positive Cells|The number of tissue T-regulatory cells, as determined by staining with FOXP3, CD4, and CD25|following adenoidectomy (2 weeks)|Some subjects were excluded due to technical issues.||cells per High power field (HPF)||Full Range|Median
756104|NCT00591773|Secondary|Change From Baseline in the 12-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 12-hour mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
756105|NCT00591773|Secondary|Change From Baseline in the Nighttime (12 am to 6 am) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
756106|NCT00591773|Secondary|Change From Baseline in the Nighttime (12 am to 6 am) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
756107|NCT00591773|Secondary|Change From Baseline in Daytime (6am to 10 pm) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
756108|NCT00591773|Secondary|Change From Baseline in Daytime (6am to 10 pm) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
756109|NCT00591773|Secondary|Change From Baseline in Mean Trough Clinic Sitting Diastolic Blood Pressure.|The change in mean trough clinic sitting diastolic blood pressure measured at final visit or week 6 relative to baseline. Diastolic blood pressure is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
756110|NCT00591773|Secondary|Change From Baseline in the 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
756111|NCT00591773|Secondary|Change From Baseline in Mean Trough Clinic Sitting Systolic Blood Pressure.|The change in mean trough clinic sitting systolic blood pressure measured at final visit or week 6 relative to baseline. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
756112|NCT00591773|Primary|Change From Baseline in the 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
756113|NCT00591825|Secondary|Cognitive Functioning Measured Using the Wisconsin Card Sorting Task|The Wisconsin Card Sorting Task measures executive functioning and cognitive flexibility. The task uses a deck of 64 cards that the participant must sort according to specified rules. The test is stopped when when six sequences of 10 correct responses have been achieved, or after the deck has been completed twice, which provides a cumulative total of 128 trials. We report the number of errors on the task, which has a range of 0 -128, with a higher score representing worse performance.|2 weeks|Two subjects did not complete the test because they had previous exposure to the test.||units on a scale||Standard Deviation|Mean
756114|NCT00591825|Secondary|Cognitive Functioning Measured Using the Iowa Gambling Test|"This test measures a person's emotional decision making. Participants are presented with virtual decks of cards on a computer. Participants are told that each card they draw will win them game money. However, sometimes cards result in losing game money. The task includes 100 trials and the total score represents the number of cards drawn from bad decks as compared to good or safe decks. Thus, the score ranges from -100 to +100, with higher sores representing better performance."|2 weeks|||units on a scale||Standard Deviation|Mean
756115|NCT00591825|Secondary|Cognitive Functioning Measured Using the Rey-Osterrieth Complex Figure Test (RCFT)|The RCFT assesses the a person’s ability to use cues to retrieve information. The test measures visuospatial construction and memory. A person is asked to draw a figure. The figure is broken down into 18 elements. The score is based on their presence, completeness, and correct placement. Each element is scored from 0-2. The Copy, Immediate, and Delay results are scored on a 36 point scale. The higher the score, the better the person performed on the test with a 0 being the minimum and 36 being the maximum score. The organization score is scored according to whether the participant drew five cohesive units of the figure together, for a range of 0-6 and a higher score indicating better organizational performance.|2 weeks|||units on a scale||Standard Deviation|Mean
756116|NCT00591825|Secondary|Cognitive Functioning Measured Using the Wechsler Memory Scale III (Logical Memory and Faces Subtests)|This scale measures the learning and memory of functioning adults. Logical Memory I and II and Faces I and II subtests were administered to participants. The tasks measure verbal and visual memory, respectively. Scoring is based on the number of story details or faces correctly recalled during immediate (Logical Memory I, Faces I) and 30 minute delayed (Logical Memory II, Faces II) conditions. Total score ranges from 0-75 on Logical Memory I, 0-50 on Logical Memory II, 0-48 on Faces I, and 0-48 on Faces II. For all subtests, higher scores indicate better memory performance.|2 Weeks|||units on a scale||Standard Deviation|Mean
756117|NCT00591825|Primary|fMRI Brain Activations During Symptom Provocation|Regions of interest (ROIs) were specified based on previous research and included amygdala, insula, dorsal anterior cingulate cortex (ACC), dorsolateral PFC (dlPFC), and hippocampus. Multiple regression analyses were used to examine differences in response between experimental conditions (spider versus butterfly images). For significant clusters of activation within ROIs, the average max percent signal change is reported. For other regions, the average max percent signal change is reported within a sphere centered at coordinates identified via previous research.|2 Weeks|There were 54 enrolled in the study. 8 subjects were excluded from fMRI analyses: 1 for claustrophobia, 3 for scanner artifact, 1 because of motion >3mm; 3 of paradigm-consistent motion which could not be corrected for.||percent signal change||Standard Deviation|Mean
756118|NCT00591851|Primary|Cardiac Saftey|LVEF by Muga scan|Baseline-18 months|||percentage of LVEF||Full Range|Median
756119|NCT00591864|Secondary|Specificity|The number of women with negative imaging test per number of women without cancer.|at least one year following imaging|||participants|||Number
756120|NCT00591864|Secondary|Sensitivity on the Per Tumor Level|Number of tumors detected per number of tumors diagnosed on surgery or biopsy.|within 1 week of surgery or biopsy|||tumors|Participants||Number
756121|NCT00591864|Primary|Sensitivity on the Per Patient Level|Sensitivity is the number of women with breast cancer detected per number of women with breast cancer diagnosed by surgery or biopsy.|within 1 week of surgery or biopsy|In the 84 patients who completed the study 28 were diagnosed with breast cancer.||participants|||Number
756122|NCT00600067|Secondary|Percent Weight Loss From Baseline to Week 56||Baseline to 56 weeks|Intent-to-treat Last-observation-carried-forward (ITT-LOCF)||percent change||Standard Error|Least Squares Mean
756123|NCT00600067|Primary|HbA1c Change From Baseline Week 0 to Week 56||Baseline to 56 weeks|Intent-to-treat Last-observation-carried-forward (ITT-LOCF)||percent change||Standard Error|Least Squares Mean
756124|NCT00600080|Primary|Subjective Lens Comfort|"Subjects were asked to rate lens performance on a scale of 0 to 100 point scale (0= Extremely poor or Cannot use lenses and 100= Excellent or Highly impressed with these lenses overall). The average score is reported. A factor analysis was used to identify the questions pertaining to product performance, a factor loading of 0.4 or greater was used."|2-week|Subjects analyzed were those who were enrolled, randomized to a study arm, and completed the study.||units on a scale||Standard Deviation|Least Squares Mean
756125|NCT00600080|Secondary|Optimum Lens Fit|Number of subjects that measured as an optimum fit. Lens fit will be assessed using the following evaluations: horizontal and vertical centration, corneal coverage and movement. Normally, for an acceptable fit, centration and movement will fall within currently accepted clinical criteria [between -1 and +1 on a -2 to +2 grading scale.|Baseline, 1-week, 2-week|Subjects analyzed were those who were enrolled, randomized to a study arm, and completed the study.||participants|||Number
756126|NCT00600080|Secondary|Subject-reported Overall Product Performance|"Subjects were asked to rate lens performance on a scale of 0 to 100 point scale (0= Extremely poor or Cannot use lenses and 100= Excellent or Highly impressed with these lenses overall). The average score is reported. A factor analysis was used to identify the questions pertaining to product performance, a factor loading of 0.4 or greater was used."|2-week|Analyzed subjects were those who were enrolled and randomized to a study arm.||units on a scale||Standard Error|Least Squares Mean
756127|NCT00600080|Primary|Visual Acuity|Measured using high contrast and low contrast vision charts without the use of spectacles (glasses) or refraction equipment (for contact lens wearers). Values are on the logMar scale where lower values (< 0) refer to 'better' values of sight. These scores are converted from a Snellen eye chart examination.|2-week|Subjects analyzed are those who were enrolled, randomized to a study arm, and completed the study.||logMAR scale||Standard Deviation|Mean
756128|NCT00600119|Secondary|Change From Baseline in Patient Assessment of Constipation-Symptoms (PAC-SYM) Questionnaire|The PAC-SYM questionnaire is a 12-item questionnaire that evaluates the severity of symptoms of constipation in 3 domains (stool, rectal, and abdominal symptoms) on a 5-point Likert scale ranging from 0 (absent) to 4 (very severe) in the 2 weeks (14 days) prior to assessment. Each domain score is the mean of the non-missing items for that domain. The total score is the mean of all non-missing items (ie, symptoms). The range is 0 (response is 'absent' for each item) to 4 (response is 'very severe' for each item). A negative change from baseline indicates improvement.|Days 1 through 28|The MITT analysis population consisted of all randomized patients who received at least 1 dose of double-blind study treatment, had a baseline value and Visit 6 evaluable data (where Visit 6 was the Week 1 visit during the double-blind study treatment period).||units on a scale||Standard Deviation|Mean
756129|NCT00600119|Secondary|Change From Baseline in Patient Assessment of Constipation-Quality of Life (PAC-QOL) Questionnaire|The PAC-QOL scale is a 28-item self-report instrument designed to evaluate the burden of constipation on patients’ everyday functioning and well-being in the 2 weeks (14 days) prior to assessment. Each item is rated on a 5-point Likert scale ranging from 0 (not at all) to 4 (extremely).The instrument can be used to generate an overall score, but is also reported to assess 4 specific constipation-related domains including: 1) worries and concerns (11 items), 2) physical discomfort (4 items), 3) psychosocial discomfort (8 items), and 4) satisfaction (5 items). Each domain score is the mean of the non-missing items for that domain. The total score is the mean of all non-missing items. The range is 0 (response is 'not at all' for each item) to 4 (response is 'extremely' for each item). A negative change from baseline indicates improvement.|Days 1 through 28|The MITT analysis population consisted of all randomized patients who received at least 1 dose of double-blind study treatment, had a baseline value and Visit 6 evaluable data (where Visit 6 was the Week 1 visit during the double-blind study treatment period).||units on a scale||Standard Deviation|Mean
756130|NCT00600119|Secondary|Change From Baseline in SBMs/Week Across the 28-day Double-blind Period|Change from baseline in SBMs/week across the 28-day double-blind period was calculated as SBMs/week during 28-day double-blind study treatment period minus baseline SBMs/week. Baseline was defined as the average SBMs/week during the 2-week OIC screening period.|Days 1 through 28|The MITT analysis population consisted of all randomized patients who received at least 1 dose of double-blind study treatment, had a baseline value and Visit 6 evaluable data (where Visit 6 was the Week 1 visit during the double-blind study treatment period).||Number of SBMs/week||Standard Deviation|Mean
756366|NCT00603187|Secondary|LH Blood Serum Concentration|Blood for measurement of serum leutenizing hormone concentrations was obtained prior to the 1st, 5th and 6th dose of GIPET™-enhanced oral acyline and 0.5,1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 60 hours after the 7th dose.|7 days|||iu/L||Standard Deviation|Mean
756131|NCT00600119|Primary|Change From Baseline in Spontaneous Bowel Movements (SBMs) Per Week During Week 1|Change from baseline in SBMs/week during Week 1 was defined as SBMs/week during the first week of double-blind study medication (between Visit 4 and Visit 6) minus baseline SBMs/week. Baseline was defined as the average SBMs/week during the 2-week OIC screening period. An SBM was defined as a BM without the use of laxatives in the previous 24 hours as recorded in the e-diary.|Days 1 through 7|The MITT analysis population consisted of all randomized patients who received at least 1 dose of double-blind study treatment, had a baseline value and Visit 6 evaluable data (where Visit 6 was the Week 1 visit during the double-blind study treatment period).||Number of SBMs/week||Standard Deviation|Mean
756132|NCT00600171|Secondary|Difference in Post Salbutamol/Albuterol FEV1 (FEV1 30 Minutes After a Single Dose of 400 µg Salbutamol/Albuterol) Between the Following Time Points: Screening and 24 Hours After Dosing on Day 28|Assessment at Visit 2/2a was made prior to the evening dose of study medication on Day 2. Participants were administered a single 400 µg dose of salbutamol/albuterol, and FEV1 was measured 30 minutes after this administration. The highest of three technically acceptable measurements was recorded. These assessments were performed as follows: between 5 PM and 10 PM, >=6 hours after the last use of salbutamol/albuterol, >=6 hours after the last caffeine consumption, >=2 hours after exercise (or strenuous activity), Screening and >=24 hours after the first dose (Visit 2) of study medication. Analysis was performed using ANCOVA with covariates of Baseline (pre-salbutamol measurement at Screening), country, sex, age, stratum, and treatment. Analysis is of the differences in absolute FEV1 measurements taken post-salbutamol/albuterol.|Screening (Visit 1) and 24 hours after dosing on Day 28 (Visit 5)|ITT Population. Only those participants available at the indicated time points were analyzed.||Liters||Standard Error|Least Squares Mean
756133|NCT00600171|Secondary|Difference in Post Salbutamol/Albuterol FEV1 (FEV1 30minutes After a Single Dose of 400 µg Salbutamol/Albuterol) Between the Following Time Points: Screening and 24 Hours After Dosing on Day 1|Assessment at Visit 2/2a was made prior to the evening dose of study medication on Day 2. Participants were administered a single 400 µg dose of salbutamol/albuterol, and FEV1 was measured 30 minutes after this administration. The highest of three technically acceptable measurements was recorded. These assessments were performed as follows: between 5 PM and 10 PM, >=6 hours after the last use of salbutamol/albuterol, >=6 hours after the last caffeine consumption, >=2 hours after exercise (or strenuous activity), Screening and >=24 hours after the first dose (Visit 2) of study medication. Analysis was performed using ANCOVA with covariates of Baseline (pre-salbutamol measurement at Screening), country, sex, age, stratum, and treatment. Analysis is of the differences in absolute FEV1 measurements taken post-salbutamol/albuterol.|Screening (Visit 1) and 24 hours after dosing on Day 1 (Visit 2)|ITT Population. Only those participants available at the indicated time points were analyzed.||Liters||Standard Error|Least Squares Mean
756134|NCT00600171|Secondary|Difference in Post Salbutamol/Albuterol FEV1 (FEV1 30 Minutes After a Single Dose of 400 µg Salbutamol/Albuterol) Between the Following Time Points: 24 Hours After Dosing on Day 1 and Day 28|Assessment at Visit 2/2a was made prior to the evening dose of study medication on Day 2. Participants were administered a single 400 µg dose of salbutamol/albuterol, and FEV1 was measured 30 minutes after this administration. The highest of three technically acceptable measurements was recorded. These assessments were performed as follows: between 5 PM and 10 PM, >=6 hours after the last use of salbutamol/albuterol, >=6 hours after the last caffeine consumption, >=2 hours after exercise (or strenuous activity), >=24 hours after the first dose (Visit 2) or last dose (Visit 5) of study medication. Analysis was performed using ANCOVA with covariates of Baseline (pre-salbutamol measurement at Screening), country, sex, age, stratum, and treatment. Analysis is of the differences in absolute FEV1 measurements taken post-salbutamol/albuterol.|24 hours after dosing on Day 1 (Visit 2) and on Day 28 (Visit 5)|ITT Population. Only those participants available at the indicated time points were analyzed.||Liters||Standard Error|Least Squares Mean
756135|NCT00600171|Secondary|Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods Averaged Over the 28-day Treatment Period|The time span during which the participants did not have to take any rescue medication (medication intended to relieve symptoms immediately) was considered to be a rescue-free period. Change from Baseline is calculated as the value at Day 28 minus the value at Baseline (defined as the last 7 days prior to randomization of the participants). Analysis was performed using ANCOVA with covariates of Baseline, country, sex, age, stratum, and treatment.|Baseline and Days 1-28|ITT Population. Only those participants available at the indicated time points were analyzed.||Percentage of rescue-free 24-hr periods||Standard Error|Least Squares Mean
756136|NCT00600171|Secondary|Mean Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods Averaged Over the 28-day Treatment Period|Participants who were symptom free for 24 hours were assessed. Change from Baseline was calculated as the value at Day 28 minus the value at Baseline (defined as the last 7 days prior to randomization of the participants). Analysis was performed using ANCOVA with covariates of Baseline, country, sex, age, stratum, and treatment.|Baseline and Days 1-28|ITT Population. Only those participants available at the indicated time points were analyzed.||Percentage of symptom-free 24-hr periods||Standard Error|Least Squares Mean
756137|NCT00600171|Secondary|Mean Change From Baseline in Daily Morning (AM) PEF Averaged Over the 28-day Treatment Period|Peak Expiratory Flow (PEF) is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Change from Baseline was calculated as the value of the averaged PEF daily AM over the 28-day treatment period (at Day 28) minus the Baseline value (defined as the last 7 days prior to randomization of the participants). Analysis was performed using ANCOVA with covariates of Baseline, country, sex, age, stratum, and treatment.|Baseline and Days 1-28|ITT Population. Only those participants available at the indicated time points were analyzed.||Liters per minute||Standard Error|Least Squares Mean
756138|NCT00600171|Secondary|Mean Change From Baseline in Trough (Pre-dose and Pre-bronchodilator) Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 28-day Treatment Period|Peak Expiratory Flow (PEF) is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Change from Baseline was calculated as the value of the averaged PEF daily PM over the 28-day treatment period (at Day 28) minus the Baseline value (defined as the last 7 days prior to randomization of the participants). Analysis was performed using ANCOVA with covariates of Baseline, country, sex, age, stratum, and treatment.|Baseline and Days 1-28|ITT Population. Only those participants available at the indicated time points were analyzed.||Liters per minute||Standard Error|Least Squares Mean
782945|NCT00815659|Secondary|Basal Interleukin 10 (IL-10) Level|IL-10 levels before (Visit 2-enrollment)|Baseline|Baseline IL-10 levels of participants||pg/mL||Standard Deviation|Mean
756139|NCT00600171|Secondary|Change From Baseline in Weighted Mean 24-hour Serial FEV1 at Day 1 and Day 28|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Change from Baseline in weighted mean for 24-hour serial FEV1 on Days 1 and Day 28 was assessed. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline (pre-dose on Day 1), country, sex, age, stratum, and treatment.|Baseline; Day 1 and Day 28 (mean post-dose FEV1 after 15, 30, and 60 minutes and 2, 3, 4, 6, 12, 16, 20, 22, 23, and 24 hours)|ITT Population. Only those participants available at the indicated time points were analyzed.||Liters||Standard Error|Least Squares Mean
756140|NCT00600171|Secondary|Mean Change From Baseline in Clinic Visit Trough FEV1 at Day 28 Per Stratum (LOCF)|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is defined as the clinic visit (pre-bronchodilator and pre-dose) FEV1 at the end of the 28-day treatment period, with the trough FEV1 defined as the mean of the 23 hour and 24 hour post-dose assessments on Day 28. Change from Baseline in trough FEV1 at the end of the treatment period (23 hours and 24 hours after dosing on Day 28) was analyzed for each stratum (Lower stratum: FEV1 percent predicted, >=40% to <=65%; Upper stratum: FEV1 percent predicted, >=65% to <=90%). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA using LOCF with covariates of Baseline (pre-dose on Day 1), country, sex, age, stratum, treatment, and treatment by stratum interaction.|Baseline and Day 28|ITT Population. The LOCF method was used to impute missing data. When the endpoint was missing, the last valid non-missing on-treatment, post-Baseline trough assessment was used instead. Only measurements from scheduled visits were used. Only those participants with available data (using LOCF) at the indicated time point were analyzed.||Liters||Standard Error|Least Squares Mean
756141|NCT00600171|Primary|Mean Change From Baseline in Clinic Visit Trough FEV1 at Day 28 (Last Observation Carried Forward [LOCF])|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is defined as the clinic visit (pre-bronchodilator and pre-dose) FEV1 at the end of the 28-day treatment period, with the trough FEV1 defined as the mean of the 23 hour and 24 hour post-dose assessments on Day 28. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using Analysis of Covariance (ANCOVA) using LOCF with covariates of Baseline (pre-dose on Day 1), country, sex, age, stratum, and treatment.|Baseline and Day 28|ITT Population: all participants who were randomized to treatment and received at least one dose of study medication. The LOCF method was used to impute missing data. When the endpoint was missing, the last valid non-missing on-treatment, post-Baseline trough assessment was used instead. Only measurements from scheduled visits were used.||Liters||Standard Error|Least Squares Mean
756142|NCT00600353|Secondary|Impact of Nausea and Vomiting on the Quality of Life of Patients Undergoing Autologous HSCT|To determine quality of life, subjects’ responses to the modified Osoba modules were converted to a 0 – 100 scale, with higher scores indicative of better QOL|24 hours, Day 3, Day 7||||||
756143|NCT00600353|Primary|Overall Emetic Response|Clinical responses were summarized using frequencies and percentages by phase, disease group, and overall. To compute emetic response by phase, the previously defined criteria were applied to each day of the three phases independently. The worst response was used to represent the response in each of these phases and overall emetic response. Overall emetic response was computed by applying the same definitions of emetic response to the entire study period.|At leaset 24 hours to more than 72 hours after chemotherapy|||Participants|||Count of Participants
756144|NCT00600353|Primary|Overall Emetic Response: Extended|"Complete Control (CC) - no emetic episode in 24 hours, no rescue medications and nausea visual scale (NVS) of ≤ 2.5, Complete Emetic Response (CR) – 0 emetic episodes, no rescue medications. Major Emetic Response (MR) – 0 to 2 emetic episodes within 24 hour period with or without rescue medications.
Minor Emetic Response (mR) – 3 to 5 emetic episodes within 24 hour period with or without rescue medications.
Failure - >5 emetic episodes within 24 hour period. No Significant Nausea (NSN) – maximum NVS ≤ 5."|72 hours after chemotherapy|||Participants|||Count of Participants
756145|NCT00600353|Primary|Overall Emetic Response: Delayed|"Complete Control (CC) - no emetic episode in 24 hours, no rescue medications and nausea visual scale (NVS) of ≤ 2.5, Complete Emetic Response (CR) – 0 emetic episodes, no rescue medications. Major Emetic Response (MR) – 0 to 2 emetic episodes within 24 hour period with or without rescue medications.
Minor Emetic Response (mR) – 3 to 5 emetic episodes within 24 hour period with or without rescue medications.
Failure - >5 emetic episodes within 24 hour period. No Significant Nausea (NSN) – maximum NVS ≤ 5."|24 to 72 hours after chemotherapy|||Participants|||Count of Participants
756146|NCT00600353|Primary|Overall Emetic Response: Acute|"Complete Control (CC) - no emetic episode in 24 hours, no rescue medications and nausea visual scale (NVS) of ≤ 2.5, Complete Emetic Response (CR) – 0 emetic episodes, no rescue medications. Major Emetic Response (MR) – 0 to 2 emetic episodes within 24 hour period with or without rescue medications.
Minor Emetic Response (mR) – 3 to 5 emetic episodes within 24 hour period with or without rescue medications.
Failure - >5 emetic episodes within 24 hour period. No Significant Nausea (NSN) – maximum NVS ≤ 5."|24 hours after chemotherapy|||Participants|||Count of Participants
756147|NCT00600821|Other Pre-specified|Plasma Concentration Change in the Uridine Diphosphate Glucuronosyltransferase 1A1 (UGT1A1) Genotype|UGT1A1 an enzyme of the glucuronidation pathway that transforms small lipophilic molecules, such as steroids, bilirubin, hormones, and drugs, into water-soluble, excretable metabolites.|Baseline (Day 1 of Cycle 1)|Data was reported in listings but not summarized due to statistical constraints.|||||
756148|NCT00600821|Secondary|Plasma Concentration of Soluble Proteins|Plasma concentrations of soluble proteins (soluble- stem-cell factor receptor (sKIT) vascular endothelial growth factor [VEGF], and vascular endothelial growth factor receptor-2 [VEGFR2], VEGFR3) may be associated with tumor angiogenesis or tumor physiology and may correlate with efficacy or biological activity. It is presented as ratio to baseline, which is obtained by dividing the plasma soluble protein concentration at each time point by its concentration at baseline.|Baseline, C1D1, C1D15, C2D1, C3D1, C4D1, C5D1, C7D1, C9D1 and C11D1|ITT population: participants randomized with study drug designated according to initial randomization, regardless of whether participants received study drug or different drug. ‘n’: participants evaluated at specific time point for each group respectively. ‘N’ (Number of participants analyzed) signifies participants evaluable for the measure.||Picogram/mL (pg/mL)||Standard Deviation|Mean
756149|NCT00600821|Secondary|Circulating Endothelial Cells (CEC) in Blood|Circulating endothelial cells (CECs) are noninvasive marker of vascular damage, remodeling, and dysfunction. Total CEC, plasma-vascular endothelial growth factor receptor-2 (pVEGFR2), VEGFR2, p-Beta-type platelet-derived growth factor receptor (pPDGFRB+) and PDGFRB+ were explored using CECs. Blood was collected to analyze effects of therapy on the number, viability/apoptotic state, and/or target activity/expression in CECs.|Baseline (C1 D1), C1 D15, C2 D1, C3 D1, C4 D1, C5 D1, C7 D1, C9 D1 and C11 D1|ITT population: participants randomized with study drug designated according to initial randomization, regardless of whether participants received study drug or different drug. ‘n’: participants evaluated at specific time point for each group respectively. ‘N’ (Number of participants analyzed) signifies participants evaluable for the measure.||Flourescent Intensity Unit (FIU)||Standard Deviation|Mean
756150|NCT00600821|Secondary|Circulating Endothelial Cells (CEC) in Blood: Total CEC|Circulating endothelial cells (CECs) are noninvasive marker of vascular damage, remodeling, and dysfunction. Total CEC, plasma-vascular endothelial growth factor receptor-2 (pVEGFR2), VEGFR2, p-Beta-type platelet-derived growth factor receptor (pPDGFRB+) and PDGFRB+ were explored using CECs. Blood was collected to analyze effects of therapy on the number, viability/apoptotic state, and/or target activity/expression in CECs.|Baseline (C1 D1), C1 D15, C2 D1, C3 D1, C4 D1, C5 D1, C7 D1, C9 D1 and C11 D1|ITT population: participants randomized with study drug designated according to initial randomization, regardless of whether participants received study drug or different drug. ‘n’: participants evaluated at specific time point for each group respectively. ‘N’ (Number of participants analyzed) signifies participants evaluable for the measure.||Cells/milliliter (cells/mL)||Standard Deviation|Mean
756151|NCT00600821|Secondary|Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile in Whole Blood|RNA expression profiles of genes which were associated with tumor growth, angiogenesis and metastases were collected and correlated with efficacy.|Baseline, C1 D1, C1 D15, C2 D1, C3 D1, C4 D1 and C5 D1|Data was not generated but sample was collected for banking and moved to a separate exploratory research database for future research.|||||
756152|NCT00600821|Secondary|European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score|QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The 13 questions comprised 1 multi-item scale for dyspnoea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, other pain, and medicine for pain). Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.|Day 1 of every cycle then every 3 weeks until final study visit (up to 2.75 years)|ITT population included participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or different drug from which they were randomized. ‘n’ signifies those participants evaluated for this measure at specific time point for each group respectively.||Units on a scale||Standard Deviation|Mean
756153|NCT00600821|Secondary|European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhoea, and financial difficulties). Most questions used 4- point scale (1 ‘Not at All’ to 4 ‘Very Much’); 2 questions used 7-point scale (1 ‘Very Poor’ to 7 ‘Excellent’). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms.|Day (D) 1 of every cycle (C) then every 3 weeks until final study visit (up to 2.75 years)|ITT population included participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or different drug from which they were randomized. ‘n’ signifies those participants evaluated for this measure at specific time point for each group respectively.||Units on a scale||Standard Deviation|Mean
756154|NCT00600821|Secondary|Population Pharmacokinetic (PK) Analysis for Axitinib (AG-013736)|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Pre-dose, 1 to 2 hours post-dose on Cycle 2 of Day 1 and Cycle 3 of Day 1||||||
756155|NCT00600821|Secondary|Duration of Response (DR)|Time in months from the first documentation of objective tumor response that is subsequently confirmed to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Baseline, every 6 weeks until disease progression or initiation of subsequent anticancer therapy up to 2.75 years|DR was calculated for the subgroup of participants from the ITT population, with a confirmed objective tumor response (CR or PR).||Months||95% Confidence Interval|Median
756156|NCT00600821|Secondary|Percentage of Participants With Objective Response (OR)|OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR: disappearance of all lesions (target and/or non target) and no appearance of new lesions. PR: at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, without progression of non target lesions and no appearance of new lesions.|Baseline, every 6 weeks until disease progression or initiation of subsequent anticancer therapy up to 2.75 years|ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.||Percentage of participants||95% Confidence Interval|Number
756197|NCT00600938|Secondary|Core Study: Safety and Tolerability of Deferasirox vs Deferoxamine Over the 12 Months Treatment Period.|Number of patients with adverse events, serious adverse events and death|12 Month|Safety Set (SS) consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline safety assessment. Patients were analyzed according to treatment received. Treatment received is defined as first study drug administered||Participants|||Number
756157|NCT00600821|Secondary|Overall Survival (OS)|Time in months from date of randomization to date of death due to any cause. OS was calculated as (the death date minus the first randomization date plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Baseline, every 6 weeks until death or bimonthly after final study visit (up to 2.75 years)|ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.||Months||95% Confidence Interval|Median
756158|NCT00600821|Primary|Progression Free Survival (PFS)|"Time in months from start of study treatment to first randomization date of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the first randomization date plus 1) divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Baseline, every 6 weeks until disease progression or initiation of subsequent anticancer therapy up to 2.75 years|Intent-to-treat (ITT) population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.||Months||95% Confidence Interval|Median
756159|NCT00600886|Secondary|Summary of Prolactin Levels After Crossover|Prolactin (PRL) levels. Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over). Extension baseline was defined as last measurement prior to the start of crossover treatment.|Extension baseline, month 12 after crossover|CAS: All patients whose first dose in the extension is different from the first dose in the core. Patients were analyzed according to the crossover treatment received.||μg/L||Standard Deviation|Mean
756160|NCT00600886|Secondary|Health-related Quality-of-life as Measured by the AcroQoL Questionnaire After Crossover|AcroQoL total scores. The AcroQoL questionnaire is unidimensional and contains 22 items divided in two scales: one that evaluates physical aspects (eight items) and another one that evaluates psychological aspects (14 items). The scoring of the questionnaire was performed as specified by the instrument developers. Extension baseline was defined as last measurement prior to the start of crossover treatment. Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over). Total scores range from 0 to 100. Higher scores represent better quality of life.|Extension baseline, months 12 after crossover|CAS: All patients whose first dose in the extension is different from the first dose in the core. Patients were analyzed according to the crossover treatment received.||scores on a scale||Standard Deviation|Mean
756161|NCT00600886|Secondary|Ring Size After Crossover|Ring size (based on jeweler’s finger gauge). Extension baseline was defined as last measurement prior to the start of crossover treatment. Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over). BL = baseline, LH = left hand, RH = right hand, CO = crossover|Extension baseline, month 12 after crossover|CAS: All patients whose first dose in the extension is different from the first dose in the core. Patients were analyzed according to the crossover treatment received. In the extension baseline, no participant had ring size on their right hand measured at the 5th digit, hence no data.||ring size||Standard Deviation|Mean
756162|NCT00600886|Secondary|Severity Scores of Acromegaly Symptoms After Crossover|"Severity scores of acromegaly symptoms (Headache, Fatigue, Perspiration, Paresthesias, Osteoarthralgia).
Symptoms were scored from 0 (no symptom) to 4 (very severe). Extension baseline was defined as last measurement prior to the start of crossover treatment. Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over)."|Extension baseline, month 12 after crossover|CAS: All patients whose first dose in the extension is different from the first dose in the core. Patients were analyzed according to the crossover treatment received.||scores on a scale||Standard Deviation|Mean
756163|NCT00600886|Secondary|Change From Extension Baseline in Tumor Volume After Crossover|"Percentage change from extension baseline in tumor volume (assessed by pituitary MRI).
Extension baseline was defined as last assessment prior to the administration of the new treatment after crossover. Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over)."|Extension baseline, months 6, 12 after crossover|CAS: All patients whose first dose in the extension is different from the first dose in the core. Patients were analyzed according to the crossover treatment received.||mm^3||Standard Deviation|Mean
756164|NCT00600886|Secondary|Summary of Mean GH Values After Crossover|Mean GH levels (based on a 5-point profile over 2 hours). Extension baseline was defined as last measurement prior to the start of crossover treatment. Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over).|Extension baseline, months 3, 6, 9, 12 after crossover|CAS: All patients whose first dose in the extension is different from the first dose in the core. Patients were analyzed according to the crossover treatment received.||μg/L||Standard Deviation|Mean
756165|NCT00600886|Secondary|Percentage of Participants With Normalization of IGF-1 After Crossover|Percentage of participants with normalization of sex- and age-adjusted IGF-1. Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over). Denominator for all time points is the Crossover Analysis Set (CAS).|Months 3, 6, 9, 12 after crossover|CAS: All patients whose first dose in the extension is different from the first dose in the core. Patients were analyzed according to the crossover treatment received.||Percentage of participants||95% Confidence Interval|Number
756166|NCT00600886|Secondary|Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L After Crossover|Percentage of participants with a reduction of mean GH levels to < 2.5μg/L (based on a 5-point 2-hour profile). Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over). Denominator for all time points is the Crossover Analysis Set (CAS).|Months 3, 6, 9, 12 after crossover|CAS: All patients whose first dose in the extension is different from the first dose in the core. Patients were analyzed according to the crossover treatment received.||Percentage of participants||95% Confidence Interval|Number
756167|NCT00600886|Secondary|Change From Baseline in Tumor Volume|Percentage change from baseline in tumor volume (assessed by pituitary MRI). Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included).|Baseline, months 6, 12, 19, 25|Full Analysis Set: All patients who were randomized into the study.||mm^3||Standard Deviation|Mean
756168|NCT00600886|Secondary|Percentage of Participants With Normalization of IGF-1|Percentage of participants with normalization of sex- and age-adjusted IGF-1. Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included). Denominator for time points up to Month 12 is the FAS. Denominator for time points after Month 12 excludes patients who completed the core and did not enter the extension. Patients who discontinued were considered non-responders for the time points after discontinuation, patients who crossed over were considered non-responders for all time points after crossover.|Months 3, 6, 9, 12, 16, 19, 22, 25|Full Analysis Set: All patients who were randomized into the study.||Percentage of participants||95% Confidence Interval|Number
756169|NCT00600886|Secondary|Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L|"Percentage of participants with a reduction of mean GH levels to < 2.5μg/L (based on a 5-point 2-hour profile).
Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included). Denominator for time points up to Month 12 is the Full Analysis Set. Denominator for time points after Month 12 excludes patients who completed the core and did not enter the extension. Patients who discontinued were considered non-responders for the time points after discontinuation, patients who crossed over were considered non-responders for all time points after crossover."|Months 3, 6, 9, 12, 16, 19, 22, 25|Full Analysis Set: All patients who were randomized into the study.||Percentage of participants||95% Confidence Interval|Number
756170|NCT00600886|Secondary|Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L and Normalization of IGF-1 After Crossover|Percentage of participants with a reduction of mean GH levels to < 2.5μg/L (based on a 5-point 2-hour profile) and normalization of sex- and age-adjusted IGF-1. Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over). Denominator for all time points is the Crossover Analysis Set (CAS).|Months 3, 6, 9, 12 after crossover|"Crossover Analysis Set (CAS): All patients whose first dose in the extension is different from the first dose in the core.
Patients were analyzed according to the crossover treatment received."||Percentage of participants||95% Confidence Interval|Number
756171|NCT00600886|Secondary|Octreotide Trough Concentrations by Incident Dose|Octreotide LAR trough concentrations by incident dose (last dose administered prior to PK sample collection). PK observations with missing concentrations, missing dose, missing elapsed time or an elapsed time from previous injection outside of 28±2 days window were excluded.|Months 1 - 12|PK analysis set: All patients with at least one LAR injection and one post-dose trough concentration data in core phase (up to month 12). No participants took the 30 mg dose in Months 1, 2 and 3, hence no data.||ng/mL||Standard Deviation|Mean
756172|NCT00600886|Secondary|Pasireotide Trough Concentrations by Incident Dose|"Pasireotide LAR trough concentrations by incident dose (last dose administered prior to PK sample collection). PK observations with missing concentrations, missing dose, missing elapsed time or an elapsed time from previous injection outside of 28±2 days window were excluded.
5 patients with evaluable PK data in the pasireotide arm received erroneously 20 mg pasireotide LAR at baseline."|Months 1 - 12|PK analysis set: All patients with at least one LAR injection and one post-dose trough concentration data in core phase (up to month 12). No participants took the 60 mg dose in Months 1, 2 and 3, hence no data.||ng/mL||Standard Deviation|Mean
756173|NCT00600886|Secondary|Duration of Response for Patients Achieving a Reduction of Mean GH Level to <2.5 μg/L and the Normalization of IGF-1 at Month 12 (No. of Responders: Pasireotide LAR = 51, Octreotide LAR = 32)|"The duration of response is defined as the time from the date that patient first met and maintained the response criteria based on primary efficacy variable to the date that patient lost response status.
Median and corresponding 95% CI are derived based on Kaplan-Meier method. Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included)."|Up to 26 months|Full Analysis Set: All patients who were randomized into the study.||Weeks||95% Confidence Interval|Median
756174|NCT00600886|Secondary|Summary of Prolactin Levels|Prolactin Levels. Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included).|Baseline, Months 12, 25|Full Analysis Set: All patients who were randomized into the study.||μg/L||Standard Deviation|Mean
756175|NCT00600886|Secondary|Health-related Quality-of-life as Measured by the AcroQoL Questionnaire|Acromegalyy quality of life (AcroQoL) total scores. The AcroQoL questionnaire is unidimensional and contains 22 items divided in two scales: one that evaluates physical aspects (eight items) and another one that evaluates psychological aspects (14 items). The scoring of the questionnaire was performed as specified by the instrument developers. Total scores range from 0 to 100. Higher scores represent better quality of life. Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included).|Baseline, Months 12, 25|Full Analysis Set: All patients who were randomized into the study.||Score on a scale||Standard Deviation|Mean
756176|NCT00600886|Secondary|Ring Size|Ring size (based on jeweler’s finger gauge). Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included).|Baseline, Months 12, 25|Full Analysis Set: All patients who were randomized into the study.||ring zize||Standard Deviation|Mean
756177|NCT00600886|Secondary|Severity Scores of Acromegaly Symptoms|Severity scores of acromegaly symptoms (Headache, Fatigue, Perspiration, Paresthesias, Osteoarthralgia). Symptoms were scored from 0 (no symptom) to 4 (very severe). Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included).|Baseline, Months 12, 25|Full Analysis Set: All patients who were randomized into the study.||scores on a scale||Standard Deviation|Mean
756178|NCT00600886|Secondary|Time to First Response for Patients Achieving a Reduction of Mean GH Level to < 2.5 μg/L and Normalization of IGF-1 (No. of Responders: Pasireotite LAR = 81, Octreotide LAR = 63) )|Time to first response for patients achieving a reduction of mean GH level to < 2.5 μg/L and normalization of IGF-1. Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included).|Up to 26 months|Full Analysis Set: All patients who were randomized into the study.||Weeks||95% Confidence Interval|Median
756179|NCT00600886|Secondary|Summary of Mean GH Values|Mean GH levels (based on a 5-point profile over 2 hours). Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included).|Baseline, Months 3, 6, 9, 12, 16, 19, 22, 25|Full Analysis Set: All patients who were randomized into the study.||μg/L||Standard Deviation|Mean
756180|NCT00600886|Secondary|Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L and Normalization of IGF-1|"Percentage of participants with a reduction of mean GH levels to < 2.5μg/L (based on a 5-point 2-hour profile) and normalization of sex- and age-adjusted IGF-1.
Denominator for time points up to Month 12 is the Full Analysis Set (FAS). Denominator for time points after Month 12 excludes patients who completed the core and did not enter the extension. Patients who discontinued were considered non-responders for the time points after discontinuation, patients who crossed over were considered non-responders for all time points after crossover. Analysis was based on data up to crossover (i.e., included data from both blinded core & ext. phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included.)"|Months 3, 6, 9, 12, 16, 19, 22, 25|Full Analysis Set: All patients who were randomized into the study.||Percentage of participants||95% Confidence Interval|Number
756181|NCT00600886|Secondary|Percentage of Participants With Normalization of IGF-1|Percentage of participants with normalization of sex- and age-adjusted IGF-1. Post surgery = patients with prior surgery but no previous medical treatment for acromegaly De novo = patients with de novo disease who refused pituitary surgery or for whom pituitary surgery was contraindicated.|12 Months|Full Analysis Set: All patients (Pts) who were randomized into the study. Pts were analyzed according to the treatment they were assigned to at randomization. Missing IGF-1 levels at Month 12 were imputed using data obtained at or after Month 6 by the LOCF (last observation carried forward) method; otherwise, Pts were considered as nonresponders.||Percentage of participants||95% Confidence Interval|Number
756182|NCT00600886|Secondary|Change From Baseline in Tumor Volume at 12 Months|Absolute and percentage change from baseline in tumor volume (assessed by pituitary MRI) Post surgery = patients with prior surgery but no previous medical treatment for acromegaly De novo = patients with de novo disease who refused pituitary surgery or for whom pituitary surgery was contraindicated.|Baseline, 12 Months|Full Analysis Set (FAS): All patients who were randomized into the study. Patients were analyzed according to the treatment they were assigned to at randomization.||mm^3||Standard Deviation|Mean
756183|NCT00600886|Secondary|Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L|"Percentage of participants with a reduction of mean GH levels to < 2.5μg/L (based on a 5-point 2-hour profile).
Post surgery = patients with prior surgery but no previous medical treatment for acromegaly De novo = patients with de novo disease who refused pituitary surgery or for whom pituitary surgery was contraindicated."|12 Months|FAS: All patients (Pts) who were randomized into the study. Pts were analyzed according to the treatment they were assigned to at randomization. Missing mean GH levels at Month 12 were imputed using data obtained at or after Month 6 by the LOCF (last observation carried forward) method; otherwise, Pts were considered as non-responders.||Percentage of participants||95% Confidence Interval|Number
756184|NCT00600886|Primary|Percentage of Participants With a Reduction of Mean GH Level to <2.5 μg/L and the Normalization of IGF-1|"Percentage of participants with a reduction of mean GH levels to <2.5μg/L (based on a 5-point 2-hour profile) and normalization of sex- and age-adjusted IGF-1.
Post surgery = patients with prior surgery but no previous medical treatment for acromegaly De novo = patients with de novo disease who refused pituitary surgery or for whom pituitary surgery was contraindicated."|12 months|Full Analysis Set: All patients (Pts) who were randomized into the study. Pts were analyzed according to the treatment they were assigned to at randomization. Missing mean GH and/or IGF-1 levels at M12 were imputed using data obtained at or after M6 by the last observation carried forward method; otherwise, Pts were considered as non-responders.||Percentage of Participants||95% Confidence Interval|Number
756185|NCT00600938|Secondary|Core Study: Single and Repeated Dose Pharmacokinetics of Deferasirox, Maximum Plasma Concentration (Tmax)|The plasma level of deferasirox (ICL670) obtained in this study was summarized descriptively. Plasma concentration was plotted by patient and by visit. Descriptive statistics included the mean, median, SD, and CV, min and max. deferasirox pharmacokinetics (PK) trough levels over the 12 months of treatment and obtained PK profiles for the 40 mg/kg/day deferasirox dose, time to reach maximum plasma concentration (Tmax)|12 Month|Pharmacokinetic Analysis Set (PAS): PAS 2: All randomized patients who received the same dose of deferasirox for at least four consecutive days prior to PK sample collection and completed PK sample collection specified in the protocol at Visit 3 or Visit 4 (pre-dose, 1, 2, and 4 hours post-dose).||(h)||Inter-Quartile Range|Median
756186|NCT00600938|Secondary|Extension Study: Change in Serum Ferritin From Baseline by Month|Serum ferritin values was summarized by descriptive statistics. Absolute value and the absolute change from baseline in serum ferritin by month was provided by treatment group.|Months 6, 12, 18 and 24|Full Analysis Set (FAS): consisted of all patients enrolled in the extension. Patients were analyzed according to the treatment they were assigned to in the beginning of the extension phase||ug/L||Standard Deviation|Mean
756187|NCT00600938|Secondary|Extension Study: Change in Liver Iron Concentration (LIC) From Baseline at Month 24|Results of liver iron content (LIC) measurements by MRI was summarized by descriptive statistics. The absolute value and the absolute change from baseline in LIC at Months 6, 12, 18 and 24 were provided by treatment group.|Months 6, 12, 18 and 24|Full Analysis Set (FAS): consisted of all patients enrolled in the extension. Patients were analyzed according to the treatment they were assigned to in the beginning of the extension phase||mg Fe/g dw||Standard Deviation|Mean
756188|NCT00600938|Secondary|Extension Study: The Cardiac Iron Concentration From T2* Values|Cardiac iron concentration (derived from T2* values) at baseline, Months 6, 12, 18 and 24 were summarized by descriptive statistics. The absolute change from baseline at Months 6, 12, 18 and 24 were also summarized by treatment group. Lliver iron concentration is expressed in units (mg of iron / g of liver tissue dry weight (dw)|Months 6, 12, 18 and 24|Full Analysis Set (FAS): consisted of all patients enrolled in the extension. Patients were analyzed according to the treatment they were assigned to in the beginning of the extension phase||mg Fe/g dw||Standard Deviation|Mean
756189|NCT00600938|Secondary|Extension Study: Cardiac Function From Baseline to Month 24 by Change in Left Ventricular Mass Indices (LVMI)|Cardiac function endpoints (LVMI) obtained by CMR at baseline, Months 6, 12, 18 and 24 were summarized by means of descriptive statistics. These analyses were conducted for the measured values as well as for the absolute changes|Months 6, 12, 18 and 24|Full Analysis Set (FAS): consisted of all patients enrolled in the extension. Patients were analyzed according to the treatment they were assigned to in the beginning of the extension phase. Cardiac function parameters over time - excluding patients in Egypt sites||gram/m^2||Standard Deviation|Mean
756190|NCT00600938|Secondary|Extension Study: Cardiac Function From Baseline to Month 24 by Change in Left Ventricular End Diastolic Volume Indices (LVEDVI)|Cardiac function endpoint (LVEDVI ) obtained by CMR at baseline, Months 6, 12, 18 and 24 were summarized by means of descriptive statistics. These analyses were conducted for the measured values as well as for the absolute changes from baseline|Months 6, 12, 18 and 24|Full Analysis Set (FAS): consisted of all patients enrolled in the extension. Patients were analyzed according to the treatment they were assigned to in the beginning of the extension phase. Cardiac function parameters over time - excluding patients in Egypt sites||mL/m^2||Standard Deviation|Mean
756191|NCT00600938|Secondary|Extension Study: Cardiac Function From Baseline to Month 24 by Change in Left Ventricular End Systolic Volume Indices (LVESVI)|Cardiac function endpoints (LVESVI) obtained by CMR at baseline, Months 6, 12, 18 and 24 were summarized by means of descriptive statistics. These analyses were conducted for the measured values as well as for the absolute changes from baseline|Months 6, 12, 18 and 24|Full Analysis Set (FAS): consisted of all patients enrolled in the extension. Patients were analyzed according to the treatment they were assigned to in the beginning of the extension phase. Cardiac function parameters over time - excluding patients in Egypt sites.||mL/m^2||Standard Deviation|Mean
756192|NCT00600938|Secondary|Extension Study: Cardiac Function From Baseline to Month 24 by Change in Left Ventricular Ejection Fraction (LVEF)|Cardiac function endpoints (LVEF) obtained by CMR at baseline, Months 6, 12, 18 and 24 were summarized by means of descriptive statistics. These analyses were conducted for the measured values as well as for the absolute changes from baseline|Months 6, 12, 18 and 24|Full Analysis Set (FAS): consisted of all patients enrolled in the extension. Patients were analyzed according to the treatment they were assigned to in the beginning of the extension phase. Cardiac function parameters over time - excluding patients in Egypt sites.||Percent||Standard Deviation|Mean
756193|NCT00600938|Secondary|Extension Study: Change From Baseline in Myocardial T2* After 24 Months Treatment|The measured T2* values, the ratio (post-baseline / baseline T2*) at Month 6, 12, 18 and 24 was summarized for FAS population along with two-sided 95% CIs. The geometric means of the ratio was presented for all treatment groups|Months 6, 12, 18 and 24|Full Analysis Set (FAS): consisted of all patients enrolled in the extension. Patients were analyzed according to the treatment they were assigned to in the beginning of the extension phase.||Ratio||95% Confidence Interval|Geometric Mean
756194|NCT00600938|Secondary|Core Study: Single and Repeated Dose Pharmacokinetics of Deferasirox, Time Points of Concentration Data|The plasma level of deferasirox (ICL670) obtained in this study was summarized descriptively. Plasma concentration was plotted by patient and by visit. For trough concentration assessments, a 2-mL blood sample was to be taken on arrival at the study site, i.e. prior to the patient receiving the daily deferasirox dose (pre-dose blood sample). A second 2-mL blood sample was to be taken 2 hours later (post-dose sample). At all other visits (Visits 3 - 14), a pre-dose sample was to be taken. For PK profile assessments, 3 blood samples were taken after 1, 2, and 4 hours post-dose in addition to the 2-mL pre-dose|Month 1 and month 2 (pre-dose, 1,2 and 4 hours post-dose)|Pharmacokinetic Analysis Set (PAS): PAS 2: All randomized patients who received the same dose of deferasirox for at least four consecutive days prior to PK sample collection and completed PK sample collection specified in the protocol at Visit 3 or Visit 4 (pre-dose, 1, 2, and 4 hours post-dose).||(umol/L)||Standard Deviation|Mean
756195|NCT00600938|Secondary|Core Study: Single and Repeated Dose Pharmacokinetics of Deferasirox, Maximum Plasma Concentration (Cmax)|The plasma level of deferasirox (ICL670) obtained in this study was summarized descriptively. Plasma concentration was plotted by patient and by visit. Descriptive statistics included the mean, median, SD, and CV, min and max. deferasirox pharmacokinetics (PK) trough levels over the 12 months of treatment and obtained PK profiles for the 40 mg/kg/day deferasirox dose, maximum plasma concentration (Cmax)|12 Month|Pharmacokinetic Analysis Set (PAS): PAS 2: All randomized patients who received the same dose of deferasirox for at least four consecutive days prior to PK sample collection and completed PK sample collection specified in the protocol at Visit 3 or Visit 4 (pre-dose, 1, 2, and 4 hours post-dose).||umol/L||Standard Deviation|Mean
756196|NCT00600938|Secondary|Core Study: Single and Repeated Dose Pharmacokinetics of Deferasirox, Area Under the Plasma Concentration-time Curve for a Dosing Interval (AUCtau)|The plasma level of deferasirox (ICL670) obtained in this study was summarized descriptively. Plasma concentration was plotted by patient and by visit. Descriptive statistics included the mean, median, SD, and CV, min and max. deferasirox pharmacokinetics (PK) trough levels over the 12 months of treatment and obtained PK profiles for the 40 mg/kg/day deferasirox dose, area under the plasma concentration-time curve for a dosing interval (AUCtau)|12 Month|Pharmacokinetic Analysis Set (PAS): PAS 2: All randomized patients who received the same dose of deferasirox for at least four consecutive days prior to PK sample collection and completed PK sample collection specified in the protocol at Visit 3 or Visit 4 (pre-dose, 1, 2, and 4 hours post-dose).||(h.ng/mL)||Standard Deviation|Mean
756198|NCT00600938|Secondary|Core Study: Cardiac Function and the Proportion of Patients Dropping Out Due to Cardiac Dysfunction After Treatment With Deferasirox vs. Deferoxamine|The number of patients withdrawn from the study due to LVEF <50%, T2* <6 ms or significant decreases in T2* ≥ 33% from baseline was provided per treatment group.|12 Month|Per Protocol Set (PPS) consisted of all randomized patients who received at least 6 months of randomized study drug, had a T2* value assessed at least 150 days after randomization, adhered to the major inclusion and none of the major exclusion criteria, and had no major protocol deviations||Participants|||Number
756199|NCT00600938|Secondary|Core Study: Cardiac Function After 6 and 12 Months of Treatment With Deferasirox vs. Deferoxamine, by Change in Left Ventricular Mass Indices (LVMI)|An absolute change from baseline in LVMI after 6, and 12 months treatment with deferasirox and DFO was summarized|6 Month, 12 Month|Per Protocol Set (PPS) consisted of all randomized patients who received at least 6 months of randomized study drug, had a T2* value assessed at least 150 days after randomization, adhered to the major inclusion and none of the major exclusion criteria, and had no major protocol deviations||gram/m^2||Standard Deviation|Mean
756200|NCT00600938|Secondary|Core Study: Core Study: Cardiac Function After 6 and 12 Months of Treatment With Deferasirox vs. Deferoxamine, by Change in Left Ventricular End Diastolic Volume Indices (LVEDVI)|An absolute change from baseline in LVEDVI after 6, and 12 months treatment with deferasirox and DFO was summarized|6 Month, 12 Month|Per Protocol Set (PPS) consisted of all randomized patients who received at least 6 months of randomized study drug, had a T2* value assessed at least 150 days after randomization, adhered to the major inclusion and none of the major exclusion criteria, and had no major protocol deviations||Percent||Standard Deviation|Mean
756201|NCT00600938|Secondary|Core Study: Cardiac Function After 6 and 12 Months Treatment With Deferasirox vs. Deferoxamine, by Change in Left Ventricular End Systolic Volume Indices (LVESVI)|An absolute change from baseline in LVESVI after 6 and 12 months treatment with deferasirox and DFO was summarized. Changes in cardiovascular magnetic resonance (CMR) measured left ventricular end systolic after 6 and 12 months treatment. Left ventricular (LV) end-systolic volume indexed to body surface area (ESVI) is a simple yet powerful echocardiographic marker of LV remodeling that can be measured easily. Left ventricular (LV) end-systolic volume (ESV) has been shown to be an important determinant of survival after myocardial infarction (MI)|6 Month, 12 Month|Per Protocol Set (PPS) consisted of all randomized patients who received at least 6 months of randomized study drug, had a T2* value assessed at least 150 days after randomization, adhered to the major inclusion and none of the major exclusion criteria, and had no major protocol deviations||Milliliter||Standard Deviation|Mean
756202|NCT00600938|Secondary|Core Study: Change From Baseline in Myocardial T2* After 6 Months Treatment|Summary statistics of T2* ratio Month 6/baseline|6 Month|Per Protocol Set (PPS) consisted of all randomized patients who received at least 6 months of randomized study drug, had a T2* value assessed at least 150 days after randomization, adhered to the major inclusion and none of the major exclusion criteria, and had no major protocol deviations||Ratio||95% Confidence Interval|Geometric Mean
756203|NCT00600938|Secondary|Core Study: Cardiac Function After 6 Months of Treatment With Deferasirox vs. Deferoxamine, by Change in Left Ventricular Ejection Fraction (LVEF)|An absolute change from baseline in LVEF after 6 months treatment with deferasirox and DFO was summarized|6 Month|Per Protocol Set (PPS) consisted of all randomized patients who received at least 6 months of randomized study drug, had a T2* value assessed at least 150 days after randomization, adhered to the major inclusion and none of the major exclusion criteria, and had no major protocol deviations||Percent||Standard Deviation|Mean
756204|NCT00600938|Secondary|Core Study: Cardiac Function After 12 Months of Treatment With Deferasirox vs. Deferoxamine, by Change in Left Ventricular Ejection Fraction (LVEF)|An absolute change from baseline in LVEF after 12 months treatment with deferasirox and compared to.DFO was tested using an analysis of covariance model including baseline left ventricular ejection fraction (LVEF) as a covariate.|12 Month|Per Protocol Set (PPS) consisted of all randomized patients who received at least 6 months of randomized study drug, had a T2* value assessed at least 150 days after randomization, adhered to the major inclusion and none of the major exclusion criteria, and had no major protocol deviations.||Percent||Standard Error|Least Squares Mean
756205|NCT00600938|Primary|Core Study: Change From Baseline in Myocardial T2* (Magnetic Resonance T2-star (T2*) Technique for the Measurement of Tissue Iron) After 12 Months Treatment|Non- inferiority in efficacy of deferasirox compared to deferoxamine (DFO) in treating cardiac iron overload as measured by T2*. A non-inferiority margin of 0.9 (90%) was applied. Due to limitations in performing heart biopsies, T2* (T2 star), a Magnetic Resonance (MR) relaxation parameter expressed in milliseconds, as is an important tool to noninvasively quantify cardiac iron concentration. Studies have shown that myocardial T2* evaluations may predict cardiac events, e.g., impaired (<56%) left ventricular ejection fraction (LVEF) is prevalent among patients with low T2*: found in 62% of patients with T2*<8 ms; 20% with T2* of 8-12 ms; and in 5% with T2* >12 ms (Tanner 2006)|12 Month|Per Protocol Set (PPS) consisted of all randomized patients who received at least 6 months of randomized study drug, had a T2* value assessed at least 150 days after randomization, adhered to the major inclusion and none of the major exclusion criteria, and had no major protocol deviations.||Millisecond||95% Confidence Interval|Geometric Mean
756206|NCT00601107|Secondary|Percentage of Participants With Static Physician’s Global Assessment (PGA) Score of Clear or Almost Clear at Week 12, 24 or Early Termination|Static PGA of psoriasis is scored on a 5-point scale (0 = clear to 4 = severe), reflecting a global consideration of the erythema, induration and scaling across all psoriatic lesions. Clear (erythema: no, scale: no, induration: no thickness); Almost Clear (erythema: light pink, scale: fine scale, induration: barely palpable); Mild (erythema: light red, scale: coarse scale on most lesions, induration: slight but visible elevation, indistinct edges); Moderate (erythema: red, scale: coarse adherent scale predominates, induration: moderate elevation with edges); and Severe (erythema: dark red to purple, scale: thickened adherent scale, induration: marked thickness distinct and pronounced edges). Percentage of participants with static PGA score of clear or almost clear are reported.|Week 12 or Early Termination, Week 24 or Early Termination|FAS included all safety set-evaluable participants with at least one post-baseline PASI assessment after the date of first dose in the treatment period.||percentage of participants|||Number
756252|NCT00601523|Secondary|UPDRS II Total Score: Change From OL Baseline|UPDRS II ranging from 0 (normal) to 52 (severe), measures activity of daily living.|OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)|Patients from FAS and who had values for UPDRS II at week 80 (patients from 248.524) or at week 72 (patients from 248.636)||Units of scale||Standard Deviation|Mean
756207|NCT00601107|Secondary|Percentage of Participants With at Least 50 Percent (%) Reduction in Psoriasis Area Severity Index (PASI) Score at Week 24 or Early Termination|PASI score: range: 0 (no disease) to 72 (maximal disease). Body was divided into head (h), trunk (t), upper (u) and lower (l) extremities. For each section, percent area of skin involved (A) was estimated: 1 (<10%) to 6 (90% - 100%), and severity was estimated by clinical signs: (erythema [E], induration [I], and desquamation [D]) on a scale: 0=no symptoms, 4=very marked. PASI score= 0.1 (E[h] + I[h] + D[h]) A[h] + 0.2 (E[u] + I[u] + D[u]) A[u] + 0.3 (E[t] + I[t] + D[t]) A[t] + 0.4 (E[l] + l[I] + D[l]) A[l].|Week 24 or Early Termination|FAS included all safety set-evaluable participants with at least one post-baseline PASI assessment after the date of first dose in the treatment period.||percentage of participants|||Number
756208|NCT00601107|Primary|Percentage of Participants With at Least 50 Percent (%) Reduction in Psoriasis Area Severity Index (PASI) Score at Week 12 or Early Termination|PASI score: range: 0 (no disease) to 72 (maximal disease). Body was divided into head (h), trunk (t), upper (u) and lower (l) extremities. For each section, percent area of skin involved (A) was estimated: 1 (<10%) to 6 (90% - 100%), and severity was estimated by clinical signs: (erythema [E], induration [I], and desquamation [D]) on a scale: 0=no symptoms, 4=very marked. PASI score= 0.1 (E[h] + I[h] + D[h]) A[h] + 0.2 (E[u] + I[u] + D[u]) A[u] + 0.3 (E[t] + I[t] + D[t]) A[t] + 0.4 (E[l] + l[I] + D[l]) A[l].|Week 12 or Early Termination|The Full Analysis Set (FAS) included all safety set-evaluable participants with at least one post-baseline PASI assessment after the date of first dose in the treatment period.||percentage of participants|||Number
756209|NCT00601146|Primary|To Prospectively Collect Data on Chest CT Screening for Patients at Increase Lung-cancer Risk After Hodgkin's Disease.|In this study, patients will under annual low-dose chest CT screening. The total number of lung cancer detected through the screening will be recorded|3 years|Enrolled patients who underwent low-dose CCT screening- number of lung cancer diagnosed||participants|||Number
756210|NCT00601250|Secondary|2 Hour Post−Prandial Glucose (PPG) Increment Over Fasting Plasma Glucose (FPG) at Week 24|This change from baseline reflects the Week 24 (2h PPG - FPG) minus the baseline (2h PPG - FPG). Means are treatment adjusted for baseline HbA1c, baseline 2h PPG increment over FPG and previous anti-diabetic medication.|Baseline and week 24|Meal Tolerance Test (MTT) set (treated and randomised patients with adequate MTT results available at the beginning and end of the randomised treatment period)||mg/dL||Standard Error|Least Squares Mean
756211|NCT00601250|Secondary|Adjusted Means for 2h Post Prandial Blood Glucose (PPG) Change From Baseline at Week 24|This change from baseline reflects the Week 24 2h PPG minus the baseline 2h PPG. Means are treatment adjusted for baseline HbA1c, baseline PPG and previous anti-diabetic medication.|Baseline and week 24|Meal Tolerance Test (MTT) set (treated and randomised patients with adequate MTT results available at the beginning and end of the randomised treatment period)||mg/dL||Standard Error|Mean
756212|NCT00601250|Secondary|Percentage of Patients Who Have a HbA1c Lowering by 0.5% at Week 24|The percentage of patients with an HbA1c reduction from baseline >= 0.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c reduction less than 0.5%.|Baseline and week 24|The Full Analysis Set (FAS) included all patients with a baseline and at least one on treatment HbA1c measurement available. Non-completers were considered as failure imputation (NCF).||percentage of patients|||Number
756213|NCT00601250|Secondary|Percentage of Patients With HbA1c<6.5% at Week 24|The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c >= 6.5%.|Baseline and week 24|This population includes the Full Analysis Set (FAS). Non-completers were considered as failure imputation (NCF).||percentage of patients|||Number
756214|NCT00601250|Secondary|Percentage of Patients With HbA1c <6.5% at Week 24|The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c >= 6.5%. Only patients with baseline HbA1c >= 6.5%|Baseline and week 24|This population includes the FAS with baseline HbA1c >= 6.5%. Non-completers were considered as failure imputation (NCF).||percentage of patients|||Number
756215|NCT00601250|Secondary|Percentage of Patients With HbA1c < 7.0% at Week 24|The percentage of patients with an HbA1c value below 7.0% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c >= 7.0%.|Baseline and week 24|This population includes the Full Analysis Set (FAS). Non-completers were considered as failure imputation (NCF).||percentage of patients|||Number
756216|NCT00601250|Secondary|Percentage of Patients With HbA1c <7.0% at Week 24.|The percentage of patients with an HbA1c value below 7.0% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c >= 7.0%. Only patients with baseline HbA1c >= 7%|Baseline and week 24|This population includes the FAS with baseline HbA1c >= 7.0%. Non-completers were considered as failure imputation (NCF).||percentage of patients|||Number
756217|NCT00601250|Secondary|FPG Change From Baseline at Week 18|This change from baseline reflects the Week 18 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 18|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.||mg/dL||Standard Error|Mean
756218|NCT00601250|Secondary|FPG Change From Baseline at Week 12|This change from baseline reflects the Week 12 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 12|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.||mg/dL||Standard Error|Mean
756219|NCT00601250|Secondary|FPG Change From Baseline at Week 6|This change from baseline reflects the Week 6 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 6|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.||mg/dL||Standard Error|Mean
756220|NCT00601250|Secondary|FPG Change From Baseline at Week 24|This change from baseline reflects the Week 24 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 24|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.||mg/dL||Standard Error|Mean
756221|NCT00601250|Secondary|HbA1c Change From Baseline at Week 18|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 18|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||Percent||Standard Error|Mean
756222|NCT00601250|Secondary|HbA1c Change From Baseline at Week 12|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 12|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||Percent||Standard Error|Mean
756223|NCT00601250|Secondary|HbA1c Change From Baseline at Week 6|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 6 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 6|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||Percent||Standard Error|Mean
756224|NCT00601250|Primary|HbA1c Change From Baseline at Week 24|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 24|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||Percent||Standard Error|Mean
756225|NCT00601354|Other Pre-specified|Weeks of Adherence to Orlistat||Number of adherent weeks over 1 year study|Intent to treat||week of adherence to orlistat||Standard Deviation|Mean
756226|NCT00601354|Secondary|Binge Frequency|frequency of objective binge days over prior 28 days|3 months: Measured from pre to post treatment|Intent to treat||% change objective binge days||Standard Deviation|Mean
756227|NCT00601354|Primary|Weight Loss|Change in weight in lbs from per to post treatment|3 months: Measured from pre to post treatment|Used intent-to-treat analysis||lbs||Standard Deviation|Mean
756228|NCT00601367|Primary|Frequency of Adverse Events||28 weeks|||participants with any adverse event|||Number
756229|NCT00601419|Primary|Proportion of Participants Achieving Clinical Efficacy: With ACTH Deficiency vs. Without ACTH Deficiency.|Number of participants achieving clinical efficacy / Number of evaluable participants. Clinical efficacy was assessed comprehensively by physicians in three categories, 'effective', 'not effective', and 'not evaluable', based on the time profile of variables.|6 month|The efficacy analysis population basically consists of the evaluable participants in whom clinical responses were assessed comprehensively based on the time profile of variables including IGF-I, blood pressures, pulse rate, lipid metabolism, body composition, QOL, and degree of participant's satisfaction.||participants|||Number
756230|NCT00601419|Primary|Proportion of Participants Achieving Clinical Efficacy by Gender.|Number of participants achieving clinical efficacy / Number of evaluable participants. Clinical efficacy was assessed comprehensively by physicians in three categories, 'effective', 'not effective', and 'not evaluable', based on the time profile of variables.|6 month|The efficacy analysis population basically consists of the evaluable participants in whom clinical responses were assessed comprehensively based on the time profile of variables including IGF-I, blood pressures, pulse rate, lipid metabolism, body composition, QOL, and degree of participant's satisfaction.||participants|||Number
756231|NCT00601419|Primary|Proportion of Participants Achieving Clinical Efficacy: <65 Years of Age vs. >=65 Years of Age.|Number of participants achieving clinical efficacy / Number of evaluable participants. Clinical efficacy was assessed comprehensively by physicians in three categories, 'effective', 'not effective', and 'not evaluable', based on the time profile of variables.|6 month|The efficacy analysis population basically consists of the evaluable participants in whom clinical responses were assessed comprehensively based on the time profile of variables including IGF-I, blood pressures, pulse rate, lipid metabolism, body composition, QOL, and degree of participant's satisfaction.||participants|||Number
756232|NCT00601419|Primary|Proportion of Participants Achieving Clinical Efficacy.|Number of participants achieving clinical efficacy / Number of evaluable participants. Clinical efficacy was assessed comprehensively by physicians in three categories, 'effective', 'not effective', and 'not evaluable', based on the time profile of variables.|6 month|The efficacy analysis population basically consists of the evaluable participants in whom clinical responses were assessed comprehensively based on the time profile of variables including IGF-I, blood pressures, pulse rate, lipid metabolism, body composition, QOL, and degree of participant's satisfaction.||participants|||Number
756233|NCT00601419|Primary|Number of Participants With Treatment Related Adverse Events of Somatropin by Initial Dose of Somatropin.|To determine whether initial dose of somatropin is a significant risk factor in the frequency of treatment related adverse events.|6 month|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.||participants|||Number
756234|NCT00601419|Primary|Number of Participants With Treatment Related Adverse Events of Somatropin: With Past History of Any Disease vs. Without Past History of Any Disease.|To determine whether past history of any disease is a significant risk factor in the frequency of treatment related adverse events.|6 month|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.||participants|||Number
756235|NCT00601419|Primary|Number of Participants With Treatment Related Adverse Events of Somatropin: With Thyroid Stimulating Hormone (TSH) Deficiency vs. Without TSH Deficiency.|To determine whether TSH deficiency is a significant risk factor in the frequency of treatment related adverse events.|6 month|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.||participants|||Number
756236|NCT00601419|Primary|Number of Participants With Treatment Related Adverse Events of Somatropin by Gender.|To determine whether gender is a significant risk factor in the frequency of treatment related adverse events.|6 month|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.||participants|||Number
756237|NCT00601419|Primary|Number of Participants With Treatment Related Adverse Events of Somatropin: <65 Years of Age vs. >=65 Years of Age.|To determine whether age is a significant risk factor in the frequency of treatment related adverse events.|6 month|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.||participants|||Number
756238|NCT00601419|Primary|Number of Unlisted Treatment Related Adverse Events According to Japanese Package Insert.|Adverse events mean all unfavorable events that occur in participants after administration of somatropin, irrespective of causal relationship to somatropin (including clinically problematic abnormal changes in laboratory test values). Treatment related adverse events were evaluated in company with the causal relationship to somatropin. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction according to Japanese package insert.|6 month|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.||events|||Number
756239|NCT00601419|Primary|Number of Participants With Treatment Related Adverse Events.|Adverse events mean all unfavorable events that occur in participants after administration of somatropin, irrespective of causal relationship to somatropin (including clinically problematic abnormal changes in laboratory test values). Treatment related adverse events were evaluated in company with the causal relationship to somatropin.|6 month|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.||participants|||Number
756240|NCT00601458|Secondary|Time to First Request of PCA Hydromorphone|Time (in hours) to first patient controlled analgesic (PCA) pump use after surgery in each of the treatment arms: placebo, pregabalin 300 mg or naproxen 550 mg.|First 24 hours following surgery|||Hours||Inter-Quartile Range|Median
756241|NCT00601458|Primary|Total Patient Controlled Analgesic (PCA) Hydromorphone Consumption Over the 24 Hours Post-surgery|Total dose (amount) of hydromorphone via patient controlled analgesic (PCA) pump required in the 24 hours post-surgery in each of the treatment arms: placebo, pregabalin 300 mg or naproxen 550 mg.|First 24 hours following surgery|||milligrams||Inter-Quartile Range|Geometric Mean
756242|NCT00601523|Secondary|Patient Rating of Convenience of Treatment Dosing|Patients were surveyed on the convenience of Once Daily dosing versus Three Times Daily dosing|80 weeks (patients from 248.524) or 72 weeks (patients from 248.636)|Patients from Full Analysis Set (FAS included all patients who received at least one dose of study medication and had at least one post-baseline efficacy assessment)||participants|||Number
756243|NCT00601523|Secondary|Patient Preference Regarding Treatment Dosing|Patients were surveyed on their preference for Once Daily dosing versus Three Times Daily dosing|80 weeks (patients from 248.524) or 72 weeks (patients from 248.636)|Patients from Full Analysis Set (FAS included all patients who received at least one dose of study medication and had at least one post-baseline efficacy assessment)||participants|||Number
756244|NCT00601523|Primary|Percentage of Patients With Adverse Events, Adverse Drug Reactions, Serious Adverse Events|The aim of this study was to obtain long-term safety and tolerability data on pramipexole ER, in patients who have previously completed a pramipexole double blind study in early PD (248.524 (NCT00479401) or 248.636 (NCT00558025)). Therefore these items were considered as a safety evaluation|80 weeks (patients from 248.524) or 72 weeks (patients from 248.636)|Patients from Treated Set (defined as all patients who were dispensed study drug and were documented to have at least one dose of investigational treatment)||Percentage of participants|||Number
756245|NCT00601523|Secondary|Pramipexole Doses Respectively After 80 Weeks Compared to Pramipexole Doses at Week 8 for Previously 248.524 Patients and After 72 Weeks Compared to Pramipexole Doses at Week 0 for Previously 248.636 Patients|Change from open-label baseline in Levodopa dose over the final 72 weeks of open-label assessment|Week 8 and week 80 (patients from 248.524) or week 0 and week 72 (patients from 248.636)|Patients from Treated Set (defined as all patients who were dispensed study drug and were documented to have at least one dose of investigational treatment) and treated until week 80 (patients from 248.524) or week 72 (patients from 248.636)||Patients|||Number
756246|NCT00601523|Secondary|L-Dopa Dose: Change From OL Baseline|Change from open-label baseline in Levodopa dose|OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)|Patients from FAS and with L-Dopa at OL baseline and at week 80 (patients from 248.524) or week 72 (patients from 248.636)||Patients|||Number
756247|NCT00601523|Secondary|Number of Patients Introducing L-Dopa Medication in OL Trial|Number of patients requiring Levodopa supplementation during the study|80 weeks (patients from 248.524) or 72 weeks (patients from 248.636)|Patients from FAS||Patients|||Number
756248|NCT00601523|Secondary|Parkinson Fatigue Scale (PFS-16) : Change From OL Baseline|PFS-16 ranging from 16 (better perceived health status) to 80 (severe symptoms of the disease) measuring aspects of fatigue that are relevant to patients with PD.|OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)|Patients from FAS and who had values for PFS-16 at week 80 (patients from 248.524) or at week 72 (patients from 248.636)||Units of scale||Standard Deviation|Mean
756249|NCT00601523|Secondary|Response in Patient Global Impression of Improvement (PGI-I)|"Patient rated evaluation of the PD symptoms on a rating scale of 7 steps, 1 meaning very much better to 7 meaning very much worse. For patients previously treated with Placebo, all patients with at least much better were considered as responders. For patients previously treated with pramipexole (PPX) ER or IR, all patients with no change to very much better were considered as responders"|OL Baseline and week 32 (patients from 248.524) or week 24 (patients from 248.636)|Patients from FAS and who had values for for PGI-I at week 32 (patients from 248.524) or at week 24 (patients from 248.636)||Patients|||Number
756250|NCT00601523|Secondary|Response in Clinical Global Impression of Improvement (CGI-I)|"Clinicians evaluation in a rating scale of 7 steps, 1 meaning very much improved to 7 meaning very much worse. For patients previously treated with Placebo, all patients with at least much improved were considered as responders. For patients previously treated with Pramipexole ER or Immediate Release (IR), all patients with no change to very much improved were considered as responders"|OL Baseline and week 32 (patients from 248.524) or week 24 (patients from 248.636)|Patients from FAS and who had values for for CGI-I at week 32 (patients from 248.524) or at week 24 (patients from 248.636)||Patients|||Number
756251|NCT00601523|Secondary|UPDRS III Total Score: Change From OL Baseline|UPDRS III ranging from 0 (normal) to 108 (severe) measures motor symptoms|OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)|Patients from FAS and who had values for UPDRS III at week 80 (patients from 248.524) or at week 72 (patients from 248.636)||Units of scale||Standard Deviation|Mean
756253|NCT00601523|Secondary|UPDRS I Total Score: Change From OL Baseline|UPDRS I ranging from 0 (normal) to 16 (severe), measures Mentation, Behavior and Mood|OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)|Patients from FAS and who had values for UPDRS I at week 80 (patients from 248.524) or at week 72 (patients from 248.636)||Units of scale||Standard Deviation|Mean
756254|NCT00601523|Secondary|Number of Patients With UPDRS II+III Response From OL Baseline at Week 80 (Patients From 248.524) or Week 72 (Patients From 248.636)|A response means an improvement of >=20% from OL baseline. UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms|OL Baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)|Patients from Full Analysis Set (FAS included all patients who received at least one dose of study medication and had at least one post-baseline efficacy assessment) and who had values for UPDRS II+III at week 80 (patients from 248.524) or at week 72 (patients from 248.636)||Patients|||Number
756255|NCT00601523|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) II+III Total Score: Change From Baseline|UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms|Open Label (OL) baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)|Patients from Full Analysis Set (FAS included all patients who received at least one dose of study medication and had at least one post-baseline efficacy assessment) and who had values for UPDRS II+III at week 80 (patients from 248.524) or at week 72 (patients from 248.636)||Units of scale||Standard Deviation|Mean
756256|NCT00601627|Secondary|Time to Treatment Failure|Time to treatment failure is defined to be the time from the date of registration to the date at which the patient is removed from treatment due to progression, adverse events, or refusal. The distribution of survival time will be estimated using the method of Kaplan-Meier.|baseline to 2 years|All patients were included in the analysis.||months||95% Confidence Interval|Median
756257|NCT00601627|Secondary|Duration of Response|Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient’s earliest best objective status is first noted to be either a CR or PR to the earliest date progression is documented.|baseline to 2 years|Too few patients reported a confirmed response to provide meaningful information into the duration of response.|||||
756258|NCT00601627|Secondary|Confirmed Response Rate|"A confirmed tumor response is defined to be a complete response (CR) or partial response (PR) noted as the objective status on 2 consecutive evaluations at least 4 weeks apart according to the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.
A complete response is defined as the disappearance of all target and non-target lesions.
A partial response is defined as at least a 30% decrease in the sum of the longest diameter (LD) of the target lesion from baseline.
Confirmed tumor response will be evaluated using the first 6 cycles of treatment."|baseline to 2 years|All patients were analyzed for this endpoint.||rate of confirmed response||95% Confidence Interval|Number
756259|NCT00601627|Secondary|Progression Free Survival (PFS)|Progression Free Survival is defined as the time from registration to the earliest documented evidence of disease progression.|baseline to 2 years|All patients were evaluable for this endpoint.||months||95% Confidence Interval|Median
756260|NCT00601627|Secondary|Overall Survival|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier|baseline to 2 years|All patients were evaluable for this endpoint.||months||95% Confidence Interval|Median
756261|NCT00601627|Primary|One Year Survival Rate|The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the exact binomial method.|Baseline to 12 months|All patients were evaluable for this endpoint.||proportion of patients||95% Confidence Interval|Number
756262|NCT00601640|Secondary|Change in Histologic Score Diagnosis and Treatment Group|Change scores were computed by subtracting baseline histologic score from End of Study histologic score. Slides were formalin fixed. Histologic Score has been developed by this research group over the course of Grant (reference below). A standardized form captures data on the following criteria: basal or suprabasilar pleomorphism (atypia); inflammation; hyperkeratosis; parakeratosis. The atypia and inflammation were rated as: none (0), mild to moderate(1), and severe (2). The remaining criteria were rated as present (1) or absent (0). Histologic Scores were computed by adding together the codes for the histologic criteria. Higher scores reflected higher level of epidermal /dermal damage.|3 months|||units on a scale||Standard Error|Mean
756263|NCT00601640|Primary|Safety of Combination Therapy With Topical Eflornithine Hydrochloride Ointment and Topical Diclofenac Sodium Gel Over 3-months|Adverse events were compared across three treatment groups by severity determined by the clinician. All adverse events were resolved by the end of follow up.|3 months|||participants|||Number
756264|NCT00601640|Primary|Changes in Putrescine Over 3 Months|Putrescine is measured in nmole/g skin per biopsy. Baseline and End of Study biopsies were measured and the change was produced by subtracting baseline levels from End of Study levels. There was one baseline biopsy and one End of Study biopsy per participant.|3 months|||nmol/g skin||Standard Error|Mean
756265|NCT00601718|Primary|Ability to Proceed to Peripheral Blood Stem Cell Collection Following Treatment||1-3 weeks post end of treatment|||Participants|||Count of Participants
756266|NCT00601718|Primary|Efficacy (Response Rate) of Vorinostat Combined With RICE Chemotherapy||3-5 weeks post end of treatment|||Participants|||Count of Participants
756267|NCT00601718|Primary|Safety and Toxicity According to CTCAE v3.0|Common dose limiting toxicities.|3-5 weeks post end of treatment|||Participants|||Count of Participants
756268|NCT00601718|Primary|Maximum Tolerated Dose of Vorinostat||28 days post last dose of study drug|||mg twice daily X 5 days|||Number
756269|NCT00601731|Secondary|GMTs in Subjects Within Each Site and in Age-Matched Control Subjects|The Geometric Mean Titers (GMTs) as measured by serum bactericidal activity at 40 months and 60 months of age and 95% CIs were calculated for each vaccine group and for each serogroup by exponentiating (base 10) the least square means of the logarithmically transformed (base 10) titers and their 95% CIs obtained from a two-way Analysis of Variance (ANOVA) with factors for vaccine group and center.|At 40 and 60 months of age|The analysis was done on MITT population||Titers||95% Confidence Interval|Geometric Mean
756442|NCT00603382|Secondary|Number of Participants With Clinical/Visual Evidence of Oropharyngeal Candidiasis|A detailed oropharyngeal examination for visual evidence of oral candidiasis was performed.|From Baseline up to Week 8/Early Withdrawal|ITT Population||participants|||Number
756270|NCT00601731|Secondary|Percentage of Subjects With hSBA ≥1:4|Percentages of subjects with hSBA ≥1:4 as measured by serum bactericidal activity at 40 months and 60 months of age and associated 95% Clopper-Pearson CIs were computed for each of the serogroups within each of the vaccinated groups and in age-matched control subjects.|At 40 and 60 months of age|The analysis was done on MITT population||Percentages of subjects||95% Confidence Interval|Number
756271|NCT00601731|Primary|Percentage of Subjects With hSBA ≥1:8|Percentages of subjects with human Serum Bactericidal Assay (hSBA) ≥1:8 as measured by serum bactericidal activity at 40 months and 60 months of age and associated 95% Clopper-Pearson CIs were computed for each of the serogroups within each of the vaccinated groups and in age-matched control subjects.|At 40 and 60 months of age|Immunogenicity was evaluated in the Modified Intent To Treat (MITT) population that included subjects who provided at least one evaluable blood sample. Thus, the difference in the number of subjects entered here versus the number of subjects in the participant flow and baseline characteristics (i.e., enrolled subjects) module.||Percentages of subjects||95% Confidence Interval|Number
756272|NCT00601796|Secondary|Number of Participants With Serious Adverse Events (SAEs)|Toxicity will be assessed using the NCI Common Terminology Criteria for Adverse Criteria (CTAE-3),Version 3.0 (www.ctep.cancer.gov). Particular attention will assess the presence of symptomatic lymphadenopathy or any local skin / soft tissue reaction at the vaccine site. Blood tests for ANA and rheumatoid factor will be performed on any patient who develops evidence of autoimmune phenomena.|3 years|All participants||participants|||Number
756273|NCT00601796|Secondary|Median Overall Survival (OS)|Analysis of Time to Progression and Survival Endpoints. All patients will be considered in the analysis of progression free survival time (time from start of treatment to progression or death) and survival time (time from initiation of treatment to death). Follow-up for this analysis will continue for all patients for their lifetimes. Time to progression and survival probabilities over time will be calculated by the method of Kaplan-Meier.|3 years|All participants||months||95% Confidence Interval|Median
756274|NCT00601796|Secondary|Median Time to Progression (TTP)|"Analysis of Time to Progression and Survival Endpoints. All patients will be considered in the analysis of progression free survival time (time from start of treatment to progression or death) and survival time (time from initiation of treatment to death). Progression is defined using the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Follow-up for this analysis will continue for all patients for their lifetimes. Time to progression and survival probabilities over time will be calculated by the method of Kaplan-Meier."|3 years|All participants||months||95% Confidence Interval|Median
756275|NCT00601796|Primary|Number of Evaluable Participants With Tumor Response|Number of participants with evaluable peripheral blood mononuclear cells (PBMCs) who demonstrated sustained tumor peptide-specific T-cell activation after vaccination. Peripheral blood mononuclear cells (PBMCs) were collected at baseline and after each vaccination. T-cell activation profiles were analyzed by ELISpot assay and tested by generalized Wilcoxon for correlation to survival.|3 years|14 participants with evaluable PBMCs||participants|||Number
756276|NCT00601835|Other Pre-specified|Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Canadian-Manufactured or US-Manufactured Tetanus and Diphtheria Toxoids Adsorbed Vaccine.|Solicited injection site reactions: Pain, Redness, and Swelling. Solicited systemic reactions: Chills, Diarrhea, Fever (temperature), Headache, Malaise, Muscle weakness, Nausea, Pain in joints, Rash, and Vomiting.|0-14 days post-vaccination|Solicited safety parameters were in all enrolled and vaccinated participants ≥ 60 years of age and one third of participants 11 to 59 years of age. A subset of the intend-to-treat population.||Participants|||Number
756277|NCT00601835|Secondary|Post-vaccination Geometric Mean Titer (GMT) to Tetanus and Diphtheria in Participants ≥ 60 Years Vaccinated With Canadian-manufactured or US-manufactured Tetanus and Diphtheria Toxoids Adsorbed Vaccine.||28 Days post-vaccination|Geometric mean titers were determined in subjects ≥ 60 years of age in the per-protocol immunogenicity population||Titers||95% Confidence Interval|Geometric Mean
756278|NCT00601835|Primary|Percentage of Participants ≥ 60 Years of Age With Antibody Levels ≥ 0.10 IU/mL to Tetanus and Diphtheria.|Seroprotection and booster responses for both tetanus and diphtheria were considered to be an antibody level of ≥ 0.10 IU/mL 28 days post-vaccination with either the Canadian-manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine or the US-manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine in participants ≥ 60 years of age.|28 Days post-vaccination|Seroprotection and Booster Responses to Tetanus and Diphtheria were determined in subjects ≥ 60 years of age in the per-protocol immunogenicity population.||Percentage of participants|||Number
756332|NCT00602472|Secondary|FPG Change From Baseline to Week 6|This change from baseline reflects the Week 6 FPG minus the baseline FPG. Means are treatment-adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 6|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.||mg/dL||Standard Error|Mean
756289|NCT00601926|Secondary|Safety of Bevacizumab in This Population of Patients|Grade 3 or higher toxicities according to CTCAE version 3.0|Up to 2 years|||toxicities|||Number
756290|NCT00601926|Primary|Response Rate to Bevacizumab in This Population.|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response, Disappearance of all target lesions; Partial Response, >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease, neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, no occurrence of progression disease for non-target lesions, and no new lesions.|Up to 2 years|Includes patients with Complete response, partial response or stable disease||patients|||Number
756291|NCT00601926|Primary|Progression Free Survival (PFS) When Bevacizumab is Administered to Patients With Unresectable and/or Metastatic Papillary Renal Cell Carcinoma.|Progression was defined by using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Up to 2 years|||months||Full Range|Median
756292|NCT00601952|Primary|Post-Traumatic Stress Disorder Checklist-Military Version (PCL-M)|The PCL-M is a 17-item questionnaire that assesses the severity of PTSD symptoms using a 5-point Likert scale ranging from “not at all” to “extremely,” with a minimum score of 17 and a maximum score of 85 (Weathers, Litz, Herman, Huska, & Keane, 1993). Participants are asked to rate to what extent they experienced PTSD symptoms over the previous month due to prior combat experiences. The military version of the PCL (PCL-M) refers specifically to a traumatic military related event (Weathers, Litz, Huska, & Keane, 1994). Research suggests that the PCL-M has good test-retest reliability (r = .70) and internal consistency (alpha = .97; Weathers et al., 1993).|Pre, Post, Followup|||units on a scale||Standard Deviation|Mean
756293|NCT00601965|Primary|Penn State Worry Questionnaire|The Penn State Worry Questionnaire is a 16-item measure of pathological worry. Scores range from 16-80, with higher scores indicating higher levels of worry.|56 weeks|||units on a scale||Standard Deviation|Mean
756294|NCT00601965|Primary|Hamilton Anxiety Rating Scale|The Hamilton Anxiety Rating Scale is a clinician-rated measure of cognitive and somatic anxiety symptoms. It consists of 14 items, each of which is scored on a 0-4 scale, summed for a total score ranging from 0 to 56. Inclusion criteria for this study included a Hamilton score >= 17. The Hamilton, administered by blind raters, will be used to test hypotheses number 1 and 2. The outcome of interest is the number of participants who relapse, defined as having a Hamilton increase of >=5, for a total Hamilton >=14, relative to the end of the continuation phase (week 28), for a duration of at least 2 weeks, plus both clinician's and participant's judgment that the participant is experiencing a recurrence of anxiety symptoms. HAMA scores range from 0 (no anxiety) to 56 (high anxiety).|56 weeks|||participants|||Number
756295|NCT00602043|Secondary|Correlation of FES Uptake With ER Assays|Graphical and numerical studies of bivariate relationships will be examined, as well as factors (i.e., tumor size, tumor location, patient age) to explain concurrence, lack of concurrence, and sources of measurement error for measurements of ER function.|Up to 6 months||||||
756296|NCT00602043|Secondary|Time to Progression|FES SUV prior to endocrine treatment (dichotomized and as a continuous predictor) will also be tested as predictor of time to progression. Analysis will be conducted using (respectively) logistic regression and Cox proportional hazards regression. This will include univariate analysis of FES and other predictive measures (ER/PgR expression, serum sex steroid levels), followed by an exploratory multivariate analysis combining FES SUV with other measures showing predictive capability univariate analysis.|Up to 6 months||||||
756297|NCT00602043|Secondary|Clinical Benefit|FES SUV prior to endocrine treatment (dichotomized and as a continuous predictor) will also be tested as predictor of CB. Analysis will be conducted using (respectively) logistic regression and Cox proportional hazards regression. This will include univariate analysis of FES and other predictive measures (ER/PgR expression, serum sex steroid levels), followed by an exploratory multivariate analysis combining FES SUV with other measures showing predictive capability univariate analysis.|Up to 6 months||||||
756298|NCT00602043|Primary|Best Overall Response|"Patients were expected to start endocrine therapy within 2 weeks of the FES PET scan. Response assessment was evaluated at 3 and 6 months. For patients with at least one site of measurable disease [per response evaluation criteria in solid tumors (RECIST, version 1.1)], size-based response criteria were used to assess response.
For patients without disease evaluable by RECIST 1.1, largely patients with bone-dominant metastatic breast cancer, serial FDG PET scanning was used to determine response. A decline in the FDG PET SUV (standard uptake value) of 30% or more was considered as response and an increase of 20% or more was considered to be progressive disease (PD).
The initial (baseline) FES uptake was compared to clinical benefit (PD versus other outcome at 6 months)."|Up to 6 months|||patients with progressive disease|||Number
756299|NCT00602225|Secondary|Overall Survival||At five years after the last dose of clofarabine|||months||95% Confidence Interval|Median
756300|NCT00602225|Secondary|Disease-free Survival||At five years after the last dose of clofarabine||||||
756301|NCT00602225|Secondary|Efficacy||At five years after the last dose of clofarabine||||||
756302|NCT00602225|Secondary|Hematologic and Non-hematologic Side Effect Profile|Data not collected.|45 days after the last dose of clofarabine||||||
756303|NCT00602225|Primary|Response Rates by Salvage Number|Number of participants in each Salvage number category who achieved a Complete Remission. Salvage number refers to whether treatment with GCLAC on this study was the pariticipant's first salvage regimen (1), second salvage regimen (2), or third or greater salvage regimen (3 or greater).|45 days after the last dose of clofarabine|Of the 50 patients, 4 were excluded from analysis of response: 2 patients with GVHD, 1 patient who received only 1 g/m2 ara-C, and 1 patient who did not have a marrow confirming remission status prior to beginning a preparative regimen for allogeneic HCT.||Participants|||Count of Participants
756304|NCT00602225|Primary|Response Rates by Duration First Complete Remission (CR1)|Number of participants whose first Complete Remission lasted 0, 1-6, 6-12, or greater than 12 months. Only those participant who had a first CR are included in this data.|45 days after the last dose of clofarabine|Of the 50 patients, 4 were excluded from analysis of response: 2 patients with GVHD, 1 patient who received only 1 g/m2 ara-C, and 1 patient who did not have a marrow confirming remission status prior to beginning a preparative regimen for allogeneic HCT.||Participants|||Count of Participants
756305|NCT00602225|Primary|Response Rates by Cytogenetic Risk Category and Clofarabine Dose|Number of participants under each Cytogenetic Risk Category and Clofarabine dose who achieve CR (Complete Remission = less than 5% blasts in the marrow and count recovery of Absolute Neutrophil Count to 1,000/microL and Platelet Count to 100,000/microL) or CRp (Complete Remission, but with a platelet count of less than 100,000/microL).|45 days after the last dose of clofarabine|Of the 50 patients, 4 were excluded from analysis of response: 2 patients with GVHD, 1 patient who received only 1 g/m2 ara-C, and 1 patient who did not have a marrow confirming remission status prior to beginning a preparative regimen for allogeneic HCT.||Participants|||Count of Participants
756306|NCT00602225|Primary|Response Rates by Cytogenetic Risk Category|Number of participants who achieved Complete Remission (less than 5% blasts in the marrow and count recovery of Absolute Neutrophil Count to 1,000/microL and Platelet Count to 100,000/microL) under each cytogenetic risk category.|45 days after the last dose of clofarabine|Of the 50 patients, 4 were excluded from analysis of response: 2 patients with GVHD, 1 patient who received only 1 g/m2 ara-C, and 1 patient who did not have a marrow confirming remission status prior to beginning a preparative regimen for allogeneic HCT.||Participants|||Count of Participants
756307|NCT00602225|Primary|Dose-limiting Toxicity as Assessed by NCI CTCAE v3.0|Two patients experienced Dose-limiting toxicities.|45 days after the last dose of clofarabine|||Participants|||Count of Participants
756308|NCT00602225|Primary|Maximum Tolerated Dose of Clofarabine||45 days after the last dose of clofarabine|||mg/m^2 of clofarabine|||Number
756309|NCT00602290|Secondary|Quality of Life Assessment||Measured at Baseline and Week 16||||||
756310|NCT00602290|Primary|Hamilton Depression Rating Scale (HDRS) Maintained Scores at Week 16|The Hamilton Depression Rating Scale (HDRS) is a 24-item depression scale and the total score is summed with a minimum score=0 and maximum score=76. There are no subscales and the higher values represent a worse outcome. Outcomes are measured and defined as follows: 1) Response will be defined as HDRS scores of 10 or less; 2) Sustained response will be defined as maintained response at week 16; 4) Remission will be defined as HDRS scores of 6 or less.|Maintained response measured at Week 16|||units on a scale||Standard Deviation|Mean
756311|NCT00602355|Secondary|Hamilton Anxiety Rating Scale (HARS)|Measure total ranges from 0 to 56, with lower scores indicating better outcomes.|Measured at baseline; post-treatment; and Months 3 and 6 of follow-up|||units on a scale||Standard Deviation|Mean
756312|NCT00602355|Secondary|Social Functioning Based on Postpartum Adjustment Questionnaire (PPAQ)|Measure total ranges from 1 to 5, with lower scores indicating better outcomes.|Measured at baseline; post-treatment; and Months 3 and 6 of follow-up|||units on a scale||Standard Deviation|Mean
756313|NCT00602355|Secondary|Global Illness Severity Based on Clinical Global Impression (CGI) Scale|Measure total ranges from 1 to 7, with lower scores indicating better outcomes.|Measured at baseline; post-treatment; and Months 3 and 6 of follow-up|||units on a scale||Standard Deviation|Mean
756314|NCT00602355|Secondary|Depression Illness Severity Based on Beck Depression Inventory (BDI)|Measure total ranges from 0 to 56, with lower scores indicating better outcomes.|Measured at baseline; post-treatment; and Months 3 and 6 of follow-up|||units on a scale||Standard Deviation|Mean
756315|NCT00602355|Primary|Hamilton Depression Rating Scale (HAM-D)|Measure total ranges from 0 to 50, with lower scores indicating better outcomes.|Measured at baseline; post-treatment; and Months 3 and 6 of follow-up|||units on a scale||Standard Deviation|Mean
756316|NCT00602420|Primary|Area Under Curve (AUC) of Average Pain From Diary vs. Day (1-5), Calculated by the Trapezoidal Rule.|Severity and duration of bone pain (day 1 being the day pegfilgrastim is administered) as measured by a daily diary. Patients recorded daily pain (Pain Scale Score) severity on a scale of 0 (no pain) to 10 (pain as bad as you can imagine) for the last 24 hours. The AUC range was 0-40, and the units are (Pain Scale Score)*Days.|From baseline through day 5|||(Pain Scale Score)*Days||95% Confidence Interval|Mean
756317|NCT00602446|Secondary|Reduction in Liver Iron Concentration After Study Drug|Efficacy as measured by reduction in liver iron concentration (LIC) after 6 months of the study drug compared to baseline (LIC at baseline minus LIC at 6 months). This shows the mean reduction for the 3 subjects treated in this study.|6 Months|All patients included in count.||milligrams/gram||Standard Deviation|Mean
756318|NCT00602446|Primary|Number of Patients Not Completing Treatment|Number of patients who discontinued deferasirox during 6 month daily treatment due to drug related toxicity|6 Months|Note: 1 patient had a transient decrease in hemoglobin that required discontinuation of treatment for 2 weeks; subsequently restarted at same dose and completed therapy.||Participants|||Number
756319|NCT00602459|Secondary|Time-to-progression in Patients With Del(11q22.3)|Time to progression (TTP) in del(11q22.3) participants was defined as the registration date to date of progression or death due to any cause, whichever occurs first. TTP was estimated using the Kaplan Meier method.|Up to 15 years|This endpoint is limited to patients with del(11q22.3).||months||95% Confidence Interval|Median
756320|NCT00602459|Secondary|Time-to-progression in Patients Without Del(11q22.3)|Time to progression (TTP) was defined as the registration date to date of progression or death due to any cause, whichever occurs first. TTP was estimated using the Kaplan Meier method. Progressive disease (PD) required at least one of the following: >= 50% increase in the absolute number of lymphocytes, appearance of new palpable lymph nodes, >= 50% increase in the product of at least two lymphnodes, >= 50% increase in the enlargement of the liver and/or spleen.|Up to 15 years|This endpoint is limited to patients without del(11q22.3).||months||95% Confidence Interval|Median
756321|NCT00602459|Secondary|PFS Rate of Patients With Del(11q22.3)|Proportion of del (11q22.3) participants who were alive and progression free at 2 years.|2 years|This endpoint is limited to patients with del(11q22.3).||proportion of participants||90% Confidence Interval|Number
756322|NCT00602459|Secondary|Induction Response Rates in Patients With Del(11q22.3)|Percentage of del (11q22.3) participants with a CR or PR.|Up to 15 years||||||
756323|NCT00602459|Secondary|Induction Response Rate in Patients Without Del(11q22.3)|Percentage of non-del(11q22.3) participants with a complete response (CR) or partial response (PR). CR: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count; confirmed by bone marrow (BM) aspirate & biopsy PR: 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence/absence of constitutional symptoms; plus >= 1 of the following: >= 1500/uL polymorphonuclear leukocytes, > 100,000/uL platelets, > 11.0 g/dL hemoglobin or 50% improvement for these parameters without transfusions.|Up to 15 years||||||
756324|NCT00602459|Primary|2-Year Progression Free Survival (PFS) Rate|Proportion of participants who were alive and progression free at 2 years.|2 years|Patients re-assigned to Arm C were split into two analysis groups, patients with del(11q22.3), as assessed by interphase cytogenetics and present in at least 20% of cells, and those without del(11q22.3). This endpoint is limited to patients without del(11q22.3).||proportion of participants||90% Confidence Interval|Number
756325|NCT00602472|Secondary|Percentage of Patients Who Have a HbA1c Lowering by 0.5% at Week 24|The percentage of patients with an HbA1c reduction greater than 0.5% at week 24 from baseline was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c reduction less than 0.5%|Baseline and week 24|The Full Analysis Set (FAS) included all patients with a baseline and at least one on treatment HbA1c measurement available. Non-completers were considered as failure imputation (NCF).||percentage of patients|||Number
756326|NCT00602472|Secondary|Percentage of Patients With HbA1c<6.5% at Week 24|The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 6.5%|Baseline and week 24|This population includes the Full Analysis Set (FAS). Non-completers were considered as failure imputation (NCF).||percentage of patients|||Number
756327|NCT00602472|Secondary|Percentage of Patients With HbA1c <6.5% at Week 24|The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 6.5%. Only patients with baseline HbA1c >= 6.5%|Baseline and week 24|This population includes the FAS with baseline HbA1c >= 6.5%. Non-completers were considered as failure imputation (NCF).||percentage of patients|||Number
756328|NCT00602472|Secondary|Percentage of Patients With HbA1c < 7.0% at Week 24|The percentage of patients with an HbA1c value below 7% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 7%.|Baseline and week 24|This population includes the Full Analysis Set (FAS). Non-completers were considered as failure imputation (NCF).||percentage of patients|||Number
756329|NCT00602472|Secondary|Percentage of Patients With HbA1c <7.0% at Week 24|The percentage of patients with an HbA1c value below 7% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 7%. Only patients with baseline HbA1c >= 7%|Baseline and week 24|This population includes the FAS with baseline HbA1c >= 7.0%. Non-completers were considered as failure imputation (NCF).||percentage of patients|||Number
756330|NCT00602472|Secondary|FPG Change From Baseline to Week 18|This change from baseline reflects the Week 18 FPG minus the Week 0 FPG. Means are treatment-adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication|Baseline and week 18|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.||mg/dL||Standard Error|Mean
756331|NCT00602472|Secondary|FPG Change From Baseline to Week 12|This change from baseline reflects the Week 12 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 12|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.||mg/dL||Standard Error|Mean
785157|NCT00835224|Primary|Blood Pressure||Blood pressure during the 4 hour period after no drug, L-NAME (IV: 1.0 mg/kg) and midodrine (PO: 10.0 mg) administration|||mmHg||Standard Deviation|Mean
756333|NCT00602472|Secondary|FPG Change From Baseline to Week 24|This change from baseline reflects the Week 24 FPG minus the baseline FPG. Means are treatment-adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 24|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.||mg/dL||Standard Error|Mean
756334|NCT00602472|Secondary|HbA1c Change From Baseline to Week 18|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 18|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||Percent||Standard Error|Mean
756335|NCT00602472|Secondary|HbA1c Change From Baseline to Week 12|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 12|"The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment.
HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule."||Percent||Standard Error|Mean
756336|NCT00602472|Secondary|HbA1c Change From Baseline to Week 6|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 6 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 6|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||Percent||Standard Error|Mean
756337|NCT00602472|Primary|HbA1c Change From Baseline to Week 24|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 24|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||Percent||Standard Error|Mean
756338|NCT00602537|Secondary|Treatment-Emergent Mood Symptoms|These subjects must be responders.|Measured at Weeks 12 and 36|||Participants|||Count of Participants
756339|NCT00602537|Primary|Depressive Relapse|"These subjects must be responders. Outcome measures were obtained at continuation weeks. Participant would be considered depressive relapse if relapsed by any of these times."|Weeks 16, 20, 24, 30, 36|||Participants|||Count of Participants
756340|NCT00602641|Secondary|Change in Functional Assessment of Cancer Therapy-Neurotoxicity Trial Outcome Index (FACT-Ntx TOI) Score From Baseline to Cycle 12|A combined scale was used to assess the quality of life (QOL) comprising of the well established and validated functional well-being (FWB) and physical well-being (PWB) components of FACT-G version 4 (14 questions), which will address the physical and functional well-being of multiple myeloma patients plus the FACT-neurotoxicity (NTX, 11 questions), which will evaluate symptoms of neurotoxicity. This pooled scale is referred to as the FACT Ntx TOI. The FACT-Ntx TOI has 25 items and the score ranges from 0 (worst possible outcome) to 100 (best possible outcome).|Administered at registration, the beginning of cycle 7 d1, the end of cycle 12 d28, then at the end of cycle 18, 24, and 38 d28. For patients who discontinue treatment early, assessed at time of discontinuation and at the next quarterly follow-up visit.|Patients who completed both baseline and cycle 12 QOL assessments.||units on a scale||Standard Deviation|Mean
756341|NCT00602641|Secondary|Very Good Partial Response (VGPR) Rate|Response evaluation was based on the International Myeloma Working Group (IMWG) response criteria. VGPR rate was defined as patients achieving at least VGPR which include patients who achieving complete response (CR) and VGPR. CR refers to patients who have complete disappearance of an M-protein and no evidence of myeloma in the bone marrow. VGPR refers to patients who meet the following criteria: Serum and urine M-component detectable by immunofixation but not on electrophoresis; Or 90% or greater reduction in serum M-component plus urine M-component <100 mg per 24 hours; If the serum and urine M protein are unmeasurable and the immunoglobulin free light chain parameter is being used to measure response, a ≥ 90% decrease in the difference between involved and uninvolved free light chain (FLC) levels is required in place of the M protein criteria.|Assessed every cycle (1 cycle=28 days) for the first 12 cycles, and then every 2 cycles while on treatment. Post treatment assessed every 3 months < 2 years from study entry, every 6 months if 2-5 years, every 12 months if 6-10 years from study entry.|Intention-to-treat (ITT) population||proportion of participants||95% Confidence Interval|Number
756342|NCT00602641|Secondary|Overall Survival|Overall survival was defined as time from randomization to death from any cause.|Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 10 years from the date of randomization.|Intention-to-treatment (ITT) population||months||95% Confidence Interval|Median
756343|NCT00602641|Primary|Progression-Free Survival (PFS)|PFS is defined as the time from randomization to the earlier of progression or death of any cause.|Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 10 years from the date of randomization.|Intention-to-treat (ITT) population||months||95% Confidence Interval|Median
756344|NCT00602771|Primary|Complete Response|Bone marrow showing less than 5% myeloblasts with normal maturation of all cell lines, an ANC of at least 1000/mcL and a platelet count of 100,000 mcL, absence of blast in peripheral blood, absence of identifiable leukemic cells in the bone marrow, clearance of disease-associated cytogenetic abnormalities, and clearance of any previously existing extramedullary disease. A CR must be confirmed 4 to 6 weeks after the initial documentation. If possible, at least one bone marrow biopsy should be performed to confirm the CR.|6 months|||participants|||Number
756356|NCT00602927|Secondary|Effect of Varenicline Treatment on Task Performance (N-back Correct Response Time)|We examined the difference in correct reaction time on the N-back task between varenicline and placebo treatment. Models included terms for the main effect of treatment period (varenicline vs. placebo), memory load (0-back, 1-back, 2-back, 3-back) and covariates. We tested for interactions between nicotine dependence severity and treatment.|Day 13|Participants who completed both study phases were included in the analysis. Other participants (n=3) were excluded due to measurement artifact.||Milliseconds||Standard Deviation|Mean
756357|NCT00602927|Primary|Percent Change BOLD Signal|We calculated the percent BOLD signal change while performing the N-back task between the varenicline vs. placebo session. We subtracted BOLD signal observed during the 0-back condition from the BOLD signal observed during the 3-back condition (3back minus 0-back)We controlled for relevant co-variates such as sex, nicotine dependence level and education.|Day 13|Participants who completed both study phases were included in the analyses (n=25). Additional participants (n=3) were excluded due to measurement artifact.||BOLD Signal Change (3-back minus 0-back)||Standard Error|Mean
756358|NCT00602979|Primary|Percentage Distribution of Cook's Modification of Cormack-Lehane's Grading System. Each Study Subject Will Receive a Grade of 1, 2A, 2B, 3A, 3B, or 4 in the Cormack-Lehane Grading System.|"Percentage distribution of Cook's modification of Cormack-Lehane's grading system. This is a classification that records the best laryngeal view obtained with or without anterior laryngeal pressure. Each study subject will receive a grade of 1, 2A, 2B, 3A, 3B, or 4 in the Cormack-Lehane grading system. Grades 1 and 2A classify as an easy view: when the laryngeal inlet is visible. Grades 2B and 3A classify as restricted: when the posterior glottic structures are visible or the epiglottis is visible and can be lifted. Grades 3B and 4 classify as difficult: when the epiglottis cannot be lifted or when no laryngeal structures are visible.
Cook's modification of Cormack-Lehane's Grades 1=1, 2=2A,3=2B, 4=3A, 5=3B, 6=4."|1 time during laryngoscopy|||units on a scale||Standard Deviation|Mean
756359|NCT00603018|Primary|Serotonin Receptor 1A Binding Potential In Regions of Interest (ROI) Accounting for Binding Potential in a Region Without Serotonin 1A Receptors|We used PET and [11C]WAY to assess 5-HT1A binding potential (BP) = [11C]WAY 100635 BP = Distribution Volume (DV)ROI−DVcerebellum in striatal regions; subcortical regions including insula, medial temporal lobe, amygdala, hippocampus, midbrain, parahippocampal gyrus; and the neocortical regions (i.e., anterior cingulate cortex). Analysis of the PET data was performed using the Logan graphical method (Logan et al. 2001) with the cerebellum as a reference region for non-displaceable uptake. 23 REC AN were studied. The Binding Potential (BP) was calculated as followed: BPP = fP Bavail/KD = VT-VND;(Abbrev.: BPP = In vivo binding potential; fP = free fraction in plasma; Bavail = Density of receptors available to bind radioligand in vivo; KD = Dissociation Constant; V = Volumes of Distribution expressed relative to total plasma ligand concentration; T = Total radioligand in tissue; ND = Nondisplaceable tissue uptake; see Innis et al. 2007); Units: mL cm -3|Baseline and 8 weeks|||mL/cm^3||Standard Deviation|Mean
756360|NCT00603044|Secondary|Adjusted Volume of the Removed Adenoids|To adjust for different weights of the children, the volume of the adenoids, estimated by water displacement in the operating room in mL, was divided by the respective weights (kg) of the patients and multiplied by 100.|following adenoidectomy (2 weeks)|Some subjects were excluded due to technical issues.||mL/kg x100||Standard Error|Mean
756361|NCT00603044|Primary|Amount of TGF Secreted by Adenoid Cells After PHA Stimulation|Amount of TGF secreted by adenoid cells after PHA stimulation|following adenoidectomy (2 weeks)|Some subjects were excluded due to technical issues.||picogram per milliliter (pg/mL)||Full Range|Median
756362|NCT00603044|Primary|Amount of IL-10 Secreted by Adenoid Cells After PHA Stimulation|Amount of IL-10 secreted by adenoid cells after PHA stimulation|following adenoidectomy (2 weeks)|Some subjects were excluded due to technical issues.||picogram per milliliter (pg/mL)||Full Range|Median
756363|NCT00603044|Primary|IL-10 Staining Intensity|IL-10 staining intensity on immunohistochemical staining of adenoid tissues. Units are Integrated optical density (IOD)/100 micrometer squared.|following adenoidectomy (2 weeks)|Some subjects were excluded due to technical issues.||IOD/100 micrometer squared||Standard Error|Mean
756364|NCT00603044|Primary|Number of CD4 Pos/FOXP3 Positive Cells|The number of tissue T-regulatory cells, as determined by staining with FOXP3, CD4, and CD25|following adenoidectomy (2 weeks)|Some subjects were excluded due to technical issues.||cells per High power field (HPF)||Full Range|Median
756367|NCT00603187|Secondary|FSH Blood Serum Concentration|Blood for measurement of serum follicle stimulating hormone concentrations was obtained prior to the 1st, 5th and 6th dose of GIPET™-enhanced oral acyline and 0.5,1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 60 hours after the 7th dose.|7 days|||iu/L||Standard Deviation|Mean
756368|NCT00603187|Primary|Testosterone Blood Serum Concentration|Blood for measurement of serum testosterone was obtained prior to the 1st, 5th and 6th dose of GIPET™-enhanced oral acyline and 0.5,1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 60 hours after the 7th dose.|7 days|||ng/dl||Standard Deviation|Mean
756369|NCT00603239|Secondary|Change in Euroqol – 5 Domain Quality of Life (EQ-5D) Score|EQ-5D Score - change from baseline to endpoint (26 weeks). EQ-5D is a 5-item questionnaire used to characterize current health states. The tool and accompanying visual analog scale (VAS) assess 5 domains of quality of life, including mobility, self-care, usual activity, pain, and anxiety/depression. Weights are used to score the responses to the 5 domains, with 3 options possible in each domain: extreme problems, some/moderate problems, or no problems. Scores range from 0 to 1, with a score of 1 representing a perfect health state.|baseline and 26 weeks|Based on primary efficacy sample size calculations. Analyses performed on ITT patient population.||units on a scale||Standard Error|Least Squares Mean
756370|NCT00603239|Secondary|Change in Impact of Weight on Quality of Life (IWQOL)-Lite Score|IWQOL-Lite analysis of change from baseline to endpoint (26 weeks). IWQOL-Lite is a 31-item questionnaire, assessing the domains of physical function, self-esteem, sexual life, public distress, and work. Response categories for each item range from 1 = “never true” to 5 = “always true.”|baseline and 26 weeks|Based on primary efficacy sample size calculations. Analyses performed on ITT patient population.||units on a scale||Standard Error|Least Squares Mean
756371|NCT00603239|Secondary|Number of Subjects Who Experienced an Episode of Minor Hypoglycemia|Overall number of subjects who experienced an episode of minor hypoglycemia.|26 weeks|Based on primary efficacy sample size calculations. Analyses performed on ITT patient population.||Participants|||Number
756372|NCT00603239|Secondary|Change in Insulin Sensitivity.|Change in homeostatic model assessment-insulin sensitivity (HOMA-S) from baseline to endpoint (26 weeks) (outcome measure is presented as the ratio of endpoint HOMA-S divided by baseline HOMA-S).|baseline and 26 weeks|Based on primary efficacy sample size calculations. Analyses performed on ITT patient population.||ratio||Standard Error|Least Squares Mean
756373|NCT00603239|Secondary|Change in Beta-cell Function|Change in homeostatic model assessment-beta cell (HOMA-B) from baseline to endpoint (Week 26) (outcome measure is presented as the ratio of endpoint HOMA-B divided by baseline HOMA-B). HOMA-B is a measure of pancreatic beta-cell function.|baseline and 26 weeks|Based on primary efficacy sample size calculations. Analyses performed on ITT patient population.||ratio||Standard Error|Geometric Mean
756374|NCT00603239|Secondary|Change in Waist Circumference|Change in waist circumference from baseline to endpoint (26 weeks)|baseline and 26 weeks|Based on primary efficacy sample size calculations. Analyses performed on ITT patient population.||cm||Standard Deviation|Mean
756375|NCT00603239|Secondary|Change in Body Weight|Change in body weight from baseline to endpoint (26 weeks)|baseline and 26 weeks|Based on primary efficacy sample size calculations. Analyses performed on ITT patient population.||kg||Standard Error|Least Squares Mean
756376|NCT00603239|Secondary|Change in Fasting Serum Glucose (FSG)|Change in FSG from baseline to endpoint (26 weeks)|baseline and 26 weeks|Based on primary efficacy sample size calculations. Analyses performed on ITT patient population.||mmol/L||Standard Error|Least Squares Mean
756377|NCT00603239|Secondary|Percentage of Patients Achieving HbA1c <= 6.5%|Percentage of ITT patients who had achieved HbA1c <= 6.5% at endpoint (Week 26 or early discontinuation)|26 weeks|Based on primary efficacy sample size calculations. Analyses performed on ITT patient population.||percentage of participants|||Number
756378|NCT00603239|Secondary|Percentage of Patients Achieving HbA1c <= 7%|Percentage of intent-to-treat (ITT) patients who had HbA1c > 7% at baseline that decreased to <= 7% at endpoint (Week 26 or early discontinuation)|26 weeks|Based on primary efficacy sample size calculations. Analyses performed on ITT patient population.||percentage of participants|||Number
756379|NCT00603239|Primary|Change in Glycosylated Hemoglobin (HbA1c)|Change in HbA1c from baseline to endpoint after 26 weeks of treatment (i.e., HbA1c at endpoint minus HbA1c at baseline)|baseline and 26 weeks|The number of participants was determined based on sample size calculations using parameter estimates from prior study H8O-MC-GWAP (NCT00099320), with change from baseline HbA1c as the primary efficacy measure. Primary analysis is reported for intent to treat population (ITT), last observation carried forward (LOCF).||Percentage||Standard Error|Least Squares Mean
756380|NCT00603265|Secondary|Change From Baseline in NPRS After Walking 50 Feet in the Clinic|The mean of the daily average scores were calculated from the NPRS pain assessments obtained 1 time per week over a 4-week period. NPRS assessments were taken after the participant walked 50 feet in the clinic. The NPRS is an 11-point scale (0 to 10) with 0 indicating no pain and 10 indicating the worst possible pain. LS means were calculated using ANCOVA with treatment group as a main factor and baseline NPRS score as a covariate. Change from baseline = NPRS at baseline - NPRS at Weeks 1, 2, 3, and 4.|Baseline, Week 1, Week 2, Week 3, Week 4|All participants who received at least 1 dose of study medication, completed the 4-week treatment period, and had evaluable post-walk NPRS data.||units on a scale||Standard Error|Least Squares Mean
756381|NCT00603265|Secondary|Change From Baseline in NPRS at Rest in the Clinic|The mean of the daily average scores were calculated from the NPRS pain assessments obtained 1 time per week over a 4-week period. NPRS assessments were taken while the participant was at rest. The NPRS is an 11-point scale (0 to 10) with 0 indicating no pain and 10 indicating the worst possible pain. LS means were calculated using ANCOVA with treatment group as a main factor and baseline NPRS score as a covariate. Change from baseline = NPRS at baseline - NPRS at Weeks 1, 2, 3, and 4.|Baseline, Week 1, Week 2, Week 3, Week 4|All participants who received at least 1 dose of study medication, completed the 4-week treatment period, and had evaluable at-rest NPRS data.||units on a scale||Standard Error|Least Squares Mean
756382|NCT00603265|Secondary|Change From Baseline in the Evening Assessment of the 24-hour Overall Mean Pain Intensity Score|At each of the evening pain assessments, participants assessed their overall pain intensity over the preceding 24 hours using NPRS. The NPRS is an 11-point scale (0 to 10) with 0 indicating no pain and 10 indicating the worst possible pain. The mean of the daily average scores were calculated from the NPRS pain assessments obtained at Baseline and Week 4. Change from baseline = NPRS at baseline - NPRS at Week 4.|Baseline, Week 4|All participants who received at least 1 dose of study medication and had evaluable 24-hour NPRS data.||units on a scale||Standard Deviation|Mean
756383|NCT00603265|Secondary|Change in Sleep Interference Scale (SIS) From Baseline|"Sleep Interference was assessed on an 11-point Numeric Rating Scale where a score of 0 indicated pain did not interfere with sleep and a score of 10 indicated pain completely interfered with sleep. Here, n signifies Number of participants for Baseline and Month 3 telephone interview whereas n signifies number of observations for Month 1, 2, and 3 because a participant could have had multiple visits during Month 1, 2, and 3 as this was a non-interventional study with no scheduled study visits, except Baseline visit and the Month 3 telephone interview. LS means were calculated using ANCOVA with treatment group as a main factor and baseline SIS score as a covariate. Change from baseline = SIS score at baseline - SIS score at Week 4."|Baseline, Week 4|All participants who received at least 1 dose of study medication, completed the 4-week treatment period, and had evaluable SIS data||units on a scale||Standard Error|Least Squares Mean
756384|NCT00603265|Secondary|Patient Global Impression of Change (PGIC)|PGIC is a participant-rated instrument that measures the change in the participant’s overall status for the previous 2 weeks based on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). The number of participants in each category is presented.|Week 4|All participants who received at least 1 dose of study medication, completed the 4-week treatment period, and had evaluable PGIC data.||participants|||Number
756385|NCT00603265|Secondary|Percentage of Responders|A responder was defined as a participant who showed a reduction in average pain (as measured by NPRS) of at least 30% from baseline to Week 4. The NPRS is an 11-point scale (0 to 10) with 0 indicating no pain and 10 indicating the worst possible pain. The percentage of participants who qualified as responders is presented per treatment arm.|Baseline, Week 4|All participants who received at least 1 dose of study medication, completed the 4-week treatment period, and had evaluable NPRS data.||percentage of participants|||Number
756386|NCT00603265|Primary|Change From Baseline in Mean Numeric Pain Rating Scale (NPRS) Score|The NPRS is an 11-point scale (0 to 10) with 0 indicating no pain and 10 indicating the worst possible pain. The mean of the daily average scores were calculated from the NPRS pain assessments obtained up to 3 times per day over a 7-day period. Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with treatment group as a main factor and baseline NPRS score as a covariate. Change from Baseline = NPRS at baseline - NPRS at Week 4; a positive number in the LS mean indicates a reduction in pain intensity from baseline.|Baseline, Week 4|All participants who received at least 1 dose of study medication and had evaluable NPRS data. Baseline-observation-carried-forward (BOCF) was used to impute missing postbaseline values for participants who were discontinued from the study early.||units on a scale||Standard Error|Least Squares Mean
756387|NCT00603278|Secondary|Change From Baseline in Heart Rate at Week 8|Change from Baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed.||Beats per minute||Standard Deviation|Mean
756388|NCT00603278|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 8|Change from Baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed.||Millimeters of mercury (mmHg)||Standard Deviation|Mean
756389|NCT00603278|Secondary|24-hour Urinary Cortisol Excretion at Baseline and Week 8|A 24-hour urine sample was collected for the measurement of 24-hour urinary cortisol excretion at the following scheduled time points: within 7 days prior to Study Visit 3 (Baseline; Week 0) and Study Visit 8 (Week 8). The Baseline value for 24-hour urinary cortisol was taken from Visit 3.|Baseline and Week 8|Urine Cortisol (UC) Population: all participants whose urine samples did not have confounding factors that could affect the interpretation of results.||Nanomole per 24 hours (nmol/24hr)||Full Range|Median
756390|NCT00603278|Secondary|Urine pH at Baseline and Week 8/Early Withdrawal|Urine samples were collected for the measurement of urine pH by dipstick method at Baseline and at Week 8/Early Withdrawal. The Baseline value was the measurement taken at screening (Visit 1). Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).|Baseline and Week 8/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||scores on a scale||Standard Deviation|Mean
756391|NCT00603278|Secondary|Urine Specific Gravity at Baseline and Week 8/Early Withdrawal|Urine samples were collected for the measurement of urine specific gravity by dipstick method at Baseline and at Week 8/Early Withdrawal. The Baseline value was the measurement taken at screening (Visit 1). Specific gravity is a measure of the amount of material dissolved in the urine. Specific gravity is the ratio of the density (mass of a unit volume) of a substance to the density (mass of the same unit volume) of a reference substance. Normal urine has a specific gravity between 1.010 and 1.020.|Urine specific gravity at Baseline and Week 8/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||ratio||Standard Deviation|Mean
756392|NCT00603278|Secondary|Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal|Urinalysis parameters included: Urine Occult Blood (UOB), Urine Glucose (UG), Urine Ketones (UK), Urine Protein (UP), and Urine Leukocyte Esterase test for detecting White Blood Cell (UWBC). The dipstick was a strip used to detect the presence or absence of these parameters in the urine sample. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative (Neg), Trace, 1+, 2+, 3+ and 4+, and for UG the result can be read as Neg, Trace, Trace or 1/10 grams per deciliter (G/dL), 1+ or 1/4 G/dL, 3+ or 1 G/dL, indicating proportional concentrations in the urine sample. Data are reported as the number of participants who had neg, Trace, 1+, 2+, 3+ and 4+ levels at Baseline (BL) and Week 8 (W8)/Early Withdrawal (WD). The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||Participants|||Number
756393|NCT00603278|Secondary|Clinical Chemistry Parameters of Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Uric Acid and Creatinine at Baseline and Week 8|Blood samples were collected for the measurement of DBIL, TBIL, uric acid and creatinine at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed.||Micromoles per liter (µmol/L)||Standard Deviation|Mean
756394|NCT00603278|Secondary|Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8|Blood samples were collected for the measurement of chloride, calcium, CO2/BI, cholesterol, glucose, PI, potassium, sodium, and urea/blood urea nitrogen (BUN) at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed.||Millimoles per liter (mmol/L)||Standard Deviation|Mean
756395|NCT00603278|Secondary|Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8|Blood samples were collected for the measurement of albumin and total protein at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at Screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed.||Grams per liter (G/L)||Standard Deviation|Mean
756396|NCT00603278|Secondary|Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8|Blood samples were collected for the measurement of ALP, ALT, AST, LD and GGT at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at Screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed.||International units per liter (IU/L)||Standard Deviation|Mean
756397|NCT00603278|Secondary|Red Blood Cells (RBC) Count at Baseline and Week 8|Blood samples were collected for the measurement of RBC count at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed.||10^12 cells per liter (TI/L)||Standard Deviation|Mean
756398|NCT00603278|Secondary|Platelet Count and White Blood Cell (WBC) Count at Baseline and Week 8|Blood samples were collected for the measurement of platelet count and WBC count at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed.||10^9 cells per liter (GI/L)||Standard Deviation|Mean
756399|NCT00603278|Secondary|Hemoglobin at Baseline and Week 8|Blood samples were collected for the measurement of hemoglobin at Baseline (BL)and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed.||Grams per liter (G/L)||Standard Deviation|Mean
756400|NCT00603278|Secondary|Hematocrit at Baseline and Week 8|Blood samples were collected for the measurement of Hematocrit at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed.||Proportion of 1||Standard Deviation|Mean
756401|NCT00603278|Secondary|Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8|Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, and total neutrophils at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed.||Percentage||Standard Deviation|Mean
756402|NCT00603278|Secondary|Number of Participants With Clinical/Visual Evidence of Oropharyngeal Candidiasis|A detailed oropharyngeal examination for visual evidence of oral candidiasis was performed for the entire Treatment Period.|From Baseline up to Week 8/Early Withdrawal|ITT Population||Participants|||Number
756403|NCT00603278|Secondary|Number of Participants With Any On-treatment Adverse Events or Serious Adverse Events Throughout the 8-week Treatment Period|An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; or is a congenital anomaly/birth defect. Medical or scientific judgment should have been exercised in other situations. Refer to the general AE/SAE module for a list of AEs (occurring at a frequency threshold >=3%) and SAEs.|From the first dose of study medication up to Week 8/Early Withdrawal|ITT Population||Participants|||Number
756404|NCT00603278|Secondary|Number of Participants Who Withdrew Due to Lack of Efficacy During the 8-Week Treatment Period|The number of participants whose primary reason for withdrawal was lack of efficacy was analyzed.|From the first dose of study medication up to Week 8/Early Withdrawal|ITT Population||Participants|||Number
756405|NCT00603278|Secondary|Mean Change From Baseline in the Percentage of Rescue Free 24-hour (hr) Periods During the 8-week Treatment Period|The number of inhalations of rescue albuterol/salbutamol inhalation aerosol used during the day and night was recorded by the participants in a daily diary. A 24-hr period in which a participant’s responses to both the morning and evening assessments indicated no use of rescue medication was considered as rescue-free. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 8-week Treatment Period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of baseline, country, sex, age, and treatment group.|From Baseline up to Week 8|ITT Population. Only those participants available at the specified time points were analyzed.||Percentage of rescue-free 24-hr periods||Standard Error|Least Squares Mean
756453|NCT00595075|Other Pre-specified|Psychomotor Vigilance Task - Number of Lapses|Number of trials per test battery with a reaction time >0.5 seconds (higher values indicate worse outcome)|8 hours|All participants completing both crossover periods||lapses||Standard Deviation|Mean
756592|NCT00596752|Secondary|All-cause Mortality During the Course of the Study (up to 196 Days)||During the course of the study (up to 196 days)|Safety Set consists of all randomized subjects who received at least one dose of trial medication.||participants|||Number
756406|NCT00603278|Secondary|Mean Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 8-week Treatment Period|Asthma symptoms were recorded in a daily dairy by the participants every day in the morning and evening before taking any rescue or study medication and before PEF measurement. A 24-hour period in which a participant’s responses to both the morning and evening assessments indicated no symptoms was considered as symptom-free. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 8-week Treatment Period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of Baseline, country, sex, age, and treatment group.|From Baseline up to Week 8|ITT Population. Only those participants available at the specified time points were analyzed.||Percentage of symptom-free 24-hr periods||Standard Error|Least Squares Mean
756407|NCT00603278|Secondary|Mean Change From Baseline in Daily Morning PEF Averaged Over the 8-week Treatment Period|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Trough PEF is defined as the PEF measurement performed at the end of the dosing interval. PEF was measured by the participants using a hand-held electronic peak flow meter each morning prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. The best of three attempts was recorded by the participants in a daily diary. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the value of the averaged daily morning PEF over the 8-week treatment period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of Baseline trough morning PEF, country, sex, age, and treatment group.|From Baseline up to Week 8|ITT Population. Only those participants available at the specified time points were analyzed.||Liters per minute||Standard Error|Least Squares Mean
756408|NCT00603278|Secondary|Mean Change From Baseline in Daily Trough (Pre-dose and Pre-rescue Bronchodilator) Evening Peak Expiratory Flow (PEF) Averaged Over the 8-week Treatment Period|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Trough PEF is defined as the PEF measurement performed at the end of the dosing interval. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. The best of three attempts was recorded by the participants in a daily diary. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the value of the averaged daily evening PEF over the 8-week treatment period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of Baseline trough evening PEF, country, sex, age, and treatment group.|From Baseline up to Week 8|ITT Population. Only those participants available at the specified time points were analyzed.||Liters per minute||Standard Error|Least Squares Mean
756409|NCT00603278|Primary|Mean Change From Baseline in Trough (Evening Pre-dose and Pre- Rescue Bronchodilator) FEV1 at Week 8|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled in one second. Pre-dose and pre-rescue bronchodilator (albuterol/salbutamol) trough FEV1 (the measurement of FEV1 performed at the end of the dosing interval) was measured electronically by spirometry in the evening at the Baseline (BL) through Week 8 clinic visits. The highest of 3 technically acceptable measurements was recorded. The Visit 3 FEV1 assessment was used as the Baseline value. Change from Baseline in trough FEV1 was calculated as the value at Week 8 minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of Baseline trough FEV1, country, sex, age, and treatment group.|Baseline and Week 8|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study medication. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-BL on-treatment measurement (scheduled and unscheduled visits) was used to impute missing measurements.||Liters||Standard Error|Least Squares Mean
756412|NCT00603304|Secondary|NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Quality of Life (QOL)Scale|The mean difference in the NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Quality of Life (QOL) scale from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Quality of Life (QOL) scale consists of three self administered questions. Two of the questions are scored on a scale of 0 – 3, with zero being none, one being only a little, two being some, and three being a lot. The third question is scored on a scale of 0 -6, with zero being delighted, one being pleased, two being mostly satisfied, three being mixed (equally satisfied and dissatisfied), four being mostly dissatisfied, five being unhappy, and six being terrible. The lowest possible score is 0 and the highest possible score is 12, which represents the highest level of dysfunction.|Baseline to 72 weeks|The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement.||units on a scale||95% Confidence Interval|Mean
756413|NCT00603304|Secondary|NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Urinary Symptom Scale|The mean difference in the NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) urinary symptom scale from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) urinary symptom scale consists of two self administered questions. The questions are scored on a scale from 0 – 5, with zero being not at all, one being less than 1 time in 5, two being less than half the time, three being about half the time, four being more than half the time, and five being almost always. The lowest possible score is 0 and the highest possible score is 10, which represents the highest level of dysfunction.|Baseline to 72 weeks|The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement.||units on a scale||95% Confidence Interval|Mean
756414|NCT00603304|Secondary|NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Pain Scale|The mean difference in the NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Pain Scale score from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Pain Scale is a four item self administered questionnaire. Three of the four items are scored on a scale from 0 – 1, with zero being no and one being yes. The fourth item is scored on a scale from 0 – 10, with zero being no pain and ten being pain as bad as you can imagine. The lowest possible score is 0 and the highest possible score is 21, which represents the highest level of pain.|Baseline to 72 weeks|The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement.||units on a scale||95% Confidence Interval|Mean
756415|NCT00603304|Secondary|Jenkins Sleep Scale Score|The mean difference in the Jenkins Sleep Dysfunction score from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. Jenkins Sleep Dysfunction score is used to assess sleep dysfunction. The four item self administered questionnaire is scored on a scale from 0 to 5, with zero being not at all, one being 1 -3 days, two being 4 – 7 days, three being 8 – 14 days, four being 15 – 21 days, and five being 22 – 31 days. The lowest possible score is 0 and the highest possible score is 20, which represents the highest level of dysfunction.|Baseline to 72 weeks|The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement.||units on a scale||95% Confidence Interval|Mean
756416|NCT00603304|Secondary|International Continence Society Male Incontinence Symptom (ICSmale IS) Score|The mean difference in the ICSmaleIS score from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The six item self administered questionnaire is scored on a scale from 0 to 4, with zero being never, one being occasionally, two being sometimes, three being most of the time, and four being all of the time. The lowest possible is 0 and the highest possible score is 24, which represents the the highest level of dysfunction.|Baseline to 72 weeks|The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement.||units on a scale||95% Confidence Interval|Mean
756417|NCT00603304|Secondary|Male Sexual Health Questionnaire - Ejaculatory Domain (MSHQ-EjD) Scale Score.|The mean difference in the MSHQ-EjD from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The MSHQ-EjD scale is used for the assessment ejaculatory dysfunction (EjD). The MSHQ-EjD consists of four self administered questions. Three of the items are scored on a scale from 0 to 5, with zero being all the time, one being most of the time, two being some of the time, three being a little of the time, four being none of the time, and five being no sexual activity. The fourth item is scored on a scale of 1 – 5, with one being not at all bothered, two being a little bit bothered, three being moderately bothered, four being very bothered, and five being extremely bothered. The lowest possible score is 0 and the highest possible score is 20, which represents the highest level of dysfunction.|Baseline to 72 weeks.|The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement.||units on a scale||95% Confidence Interval|Mean
756418|NCT00603304|Secondary|International Index of Erectile Function (IIEF)Scale Score.|The mean difference in the IIEF score from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The IIEF is a multidimensional scale for assessment of erectile dysfunction. The six item self administered questionnaire is scored on a scale from 0 to 5, with zero being no sexual activity, one being never or almost never, two being a few times (much less than half the time), three being sometimes (much less than half the time), four being most times (much more than half the time), and five being always or almost always. The lowest possible score is 0 and the highest possible score is 30, which represents less dysfunction.|Baseline to 72 weeks|The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement.||units on a scale||95% Confidence Interval|Mean
756419|NCT00603304|Secondary|Prostate Specific Antigen (PSA) Level|The mean difference in the PSA level from baseline to 72 weeks in the modified intention to treat analysis. The PSA level was measured in nanograms/milliliters. The higher units indicated greater dysfunction.|Baseline to 72 weeks|The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement.||ng/mL||95% Confidence Interval|Mean
756420|NCT00603304|Secondary|Post-void Residual|The mean difference in the participants' post-void residual from baseline to 72 weeks in the modified intention to treat analysis. The post-void residual was measured in milliliters. The higher units indicated greater dysfunction.|Baseline to 72 weeks|The analysis population was determined by the number of participants that were randomized and included in the modified intention to treat analyses.||mL||95% Confidence Interval|Mean
756421|NCT00603304|Secondary|Peak Uroflow|The mean difference in the participants' peak uroflow from baseline to 72 weeks in the modified intention to treat analysis. The peak uroflow was measured in milliliters/seconds. The higher units indicated greater dysfunction.|Baseline to 72 weeks|The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement.||mL/sec||95% Confidence Interval|Mean
756422|NCT00603304|Secondary|American Urological Association(AUA) Nocturia Item|The mean difference in the nocturia item of the AUA Symptom Score from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The nocturia item is a self administered question from the AUA Symptom Score Index that assesses the number of times a participant typically gets up to urinate from the time he goes to bed at night until the time he gets up in the morning. The question is scored on a scale of zero to five, with zero being none, one being one time, two being two times, three being three times, four being four times, and five being five or more times. The lowest possible score is 0 and the highest possible score is 5, which would represent the highest level dysfunction.|Baseline to 72 weeks|The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement.||units on a scale||95% Confidence Interval|Mean
756423|NCT00603304|Secondary|International Prostate Symptom Score Quality of Life (IPSS QOL) Score|The mean difference in the IPSS Quality-of-Life Question from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The IPSS Quality-of-Life Question is an additional question to the AUA Symptom Score. The self administered question is scored on a scale from 0 to 6, with zero being delighted, one being pleased, two being mostly satisfied, three being mixed-about equally satisfied and dissatisfied, four being mostly dissatisfied, five being unhappy, and six being terrible. The lowest possible score is 0 and the highest possible score is 6, which would represent the greatest dysfunction.|Baseline to 72 weeks|The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement.||units on a scale||95% Confidence Interval|Mean
756424|NCT00603304|Secondary|Benign Prostate Hyperplasia (BPH) Impact Index Score|The mean difference in the BPH Impact Index score from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The BPH Index Score is a self administered 4 item index. Three questions are scored on a scale from 0 to 3, with zero being none, one being only a little, two being some, and three being a lot. One question is scored on a scale from 0 to 4, with zero being none of the time, one being a little of the time, two being some of the time, three being most of the time, and four being all of the time. The lowest possible score is 0 and the highest possible score is 13, which would represent the greatest dysfunction.|Baseline to 72 weeks|The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement.||units on a scale||95% Confidence Interval|Mean
756425|NCT00603304|Secondary|Participants Global Assessments of Improvement and Satisfaction at End of Study.|Participants' global assessments of improvement and satisfaction at the end of the study. Likert scales were transformed to a 0 - 100 scale. The lowest possible score is 0 and the highest possible score is 100, which would reflect better outcomes.|Baseline to 72 weeks|The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement.||units on a scale||95% Confidence Interval|Mean
756426|NCT00603304|Primary|Mean and Standard Deviation of the Participant American Urological Association (AUA)Symptom Score Between Baseline and Week 72 for CAMUS Participants.|The primary outcome was the mean difference in the AUA Symptom Score between baseline and 72 weeks between the saw palmetto and placebo groups. The AUA Symptom Score index is a seven item questionnaire assessing the frequency of lower urinary tract symptoms (LUTS). The questions are scored on a scale of zero to five, with zero being never, one to four being one to four accordingly, and five equaling five or more times. A Symptom Index is determined by adding the scores. The lowest possible score is 0 and the highest possible score is 35, which would represent the highest level of pain and discomfort.|Baseline to 72 weeks|The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement.||units on a scale||95% Confidence Interval|Mean
756427|NCT00603382|Secondary|Change From Baseline in Heart Rate at Week 8|Change from Baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed.||Beats per minute||Standard Deviation|Mean
756428|NCT00603382|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 8|Change from Baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed.||Millimeters of mercury (mmHg)||Standard Deviation|Mean
756429|NCT00603382|Secondary|24-hour Urinary Cortisol Excretion at Baseline and Week 8|A 24-hour urine sample was collected for the measurement of 24 hr urinary cortisol excretion at the following scheduled time points: within 7 days prior to Study Visits 3 (Week 0) and Visit 8 (Week 8). The Baseline value for 24 hr urinary cortisol was taken from Visit 3.|Baseline and Week 8|Urine Cortisol (UC) Population: all participants whose urine samples did not have confounding factors that could affect the interpretation of results.||Nanomoles per 24 hours (nmol/24 hours)||Full Range|Median
756430|NCT00603382|Secondary|Urine pH at Baseline and Week 8/Early Withdrawal|Urine samples were collected for the measurement of urine pH by dipstick method at Baseline and at Week 8/Early Withdrawal. The Baseline value was the measurement taken at screening (Visit 1). Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).|Baseline and Week 8/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||scores on a scale||Standard Deviation|Mean
756431|NCT00603382|Secondary|Urine Specific Gravity at Baseline and Week 8/Early Withdrawal|Urine samples were collected for the measurement of urine specific gravity by dipstick method at Baseline and at Week 8/Early Withdrawal. The Baseline value was the measurement taken at screening (Visit 1). Specific gravity is a measure of the amount of material dissolved in the urine. Specific gravity is the ratio of the density (mass of a unit volume) of a substance to the density (mass of the same unit volume) of a reference substance. Normal urine has a specific gravity between 1.010 and 1.020.|Baseline and Week 8/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||ratio||Standard Deviation|Mean
756454|NCT00595075|Other Pre-specified|Psychomotor Vigilance Task - Median Reaction Time|Visual-motor reaction time in which participants hit a button on a response box as fast as possible in response to a visual target (lower values indicate better outcome)|8 hours|All participants completing both crossover periods||seconds||Standard Deviation|Mean
756455|NCT00595075|Other Pre-specified|Post Nap Assessment - Karolinska Drowsiness Test|EEG spectral analysis of 5.5-9.0 Hz frequency activity (theta low-frequency alpha), with higher activity indicating increased drowsiness and worse outcome|71 minutes|All participants completing both crossover periods||microvolts^2/Hz||Standard Deviation|Mean
756432|NCT00603382|Secondary|Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal|Urinalysis parameters included: Urine Occult Blood (UOB), Urine Glucose (UG), Urine Ketones (UK), Urine Protein (UP), and Urine Leukocyte Esterase test for detecting White Blood Cell (UWBC). The dipstick was a strip used to detect the presence or absence of these parameters in the urine sample. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as large, moderate (Mod), negative (Neg), small, Trace, 1+, 2+, 3+ and 4+, and for UG the result can be read as Neg, Trace, Trace or 1/10 G/dL, 1+ or 1/4 G/dL, 3+ or 1 G/dL, indicating proportional concentrations in the urine sample. Data are reported as the number of participants who had neg, Trace, 1+, 2+, 3+ and 4+ levels at Baseline (BL) and Week 8 (W8)/Early Withdrawal (EW). The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||participants|||Number
756433|NCT00603382|Secondary|Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8|Blood samples were collected for the measurement of creatinine, direct bilirubin (DBIL), total bilirubin (TBIL), and uric acid at Baseline and Week 8. The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||Micromoles per liter (µmol/L)||Standard Deviation|Mean
756434|NCT00603382|Secondary|Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8|Blood samples were collected for the measurement of chloride, calcium, CO2/BI, cholesterol, glucose, PI, potassium, sodium, and urea/blood urea nitrogen at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||Millimoles per liter (mmol/L)||Standard Deviation|Mean
756435|NCT00603382|Secondary|Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8|Blood samples were collected for the measurement of albumin and total protein at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at Screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||Grams per liter (g/L)||Standard Deviation|Mean
756436|NCT00603382|Secondary|Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8|Blood samples were collected for the measurement of ALP, ALT, AST, LD and GGT at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at Screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||International units per liter (IU/L)||Standard Deviation|Mean
756437|NCT00603382|Secondary|Red Blood Cells (RBC) Count at Baseline and Week 8|Blood samples were collected for the measurement of RBC count at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||10^12 cells per liter (TI/L)||Standard Deviation|Mean
756438|NCT00603382|Secondary|Platelet Count and White Blood Cell (WBC) Count at Baseline and Week 8|Blood samples were collected for the measurement of platelet count and WBC count at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||10^9 cells per liter (GI/L)||Standard Deviation|Mean
756439|NCT00603382|Secondary|Hemoglobin at Baseline and Week 8|Blood samples were collected for the measurement of hemoglobin at Baseline (BL)and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Grams per liter (G/L)||Standard Deviation|Mean
756440|NCT00603382|Secondary|Hematocrit at Baseline and Week 8|Blood samples were collected for the measurement of Hematocrit at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Proportion of 1||Standard Deviation|Mean
756441|NCT00603382|Secondary|Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8|Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, and total neutrophils at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||Percentage||Standard Deviation|Mean
756443|NCT00603382|Secondary|Number of Participants With Any On-treatment Adverse Events or Serious Adverse Events Throughout the 8-week Treatment Period|An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; or is a congenital anomaly/birth defect. Medical or scientific judgment should have been exercised in other situations. Refer to the general AE/SAE module for a list of AEs (occurring at a frequency threshold >=3%) and SAEs.|From the first dose of study medication up to Week 8/Early Withdrawal|ITT Population||participants|||Number
756444|NCT00603382|Secondary|Number of Participants Who Withdrew Due to Lack of Efficacy During the 8-Week Treatment Period|The number of participants whose primary reason for withdrawal was lack of efficacy was analyzed.|From the first dose of study medication up to Week 8/Early Withdrawal|ITT Population||participants|||Number
756445|NCT00603382|Secondary|Mean Change From Baseline in the Percentage of Rescue Free 24-hour (hr) Periods During the 8-week Treatment Period|The number of inhalations of rescue albuterol/salbutamol inhalation aerosol used during the day and night was recorded by the participants in a daily diary. A 24-hour period in which a participant’s responses to both the morning and evening assessments indicated no use of rescue medication was considered as rescue-free. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 8-week Treatment Period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of Baseline, country, sex, age, and treatment group.|From Baseline up to Week 8|ITT Population. Only those participants available at the specified time points were analyzed.||Percentage of rescue-free 24-hr periods||Standard Error|Least Squares Mean
756446|NCT00603382|Secondary|Mean Change From Baseline in the Percentage of Symptom-free 24 Hour (hr) Periods During the 8-week Treatment Period|Asthma symptoms were recorded in a daily dairy by the participants every day in the morning and evening before taking any rescue or study medication and before PEF measurement. A 24-hour period in which a participant’s responses to both the morning and evening assessments indicated no symptoms was considered as symptom-free. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 8-week Treatment Period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of Baseline, country, sex, age, and treatment group.|From Baseline up to Week 8|ITT Population. Only those participants available at the specified time points were analyzed.||Percentage of symptom-free 24-hr periods||Standard Error|Least Squares Mean
756447|NCT00603382|Secondary|Mean Change From Baseline in Daily Morning PEF Averaged Over the 8-week Treatment Period|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Trough PEF is defined as the PEF measurement performed at th end of the dosing interval. PEF was measured by the participants using a hand-held electronic peak flow meter each morning prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. The best of three attempts was recorded by the participants in a daily diary. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the value of the averaged daily morning PEF over the 8-week treatment period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of Baseline trough morning PEF, country, sex, age, and treatment group.|From Baseline up to Week 8|ITT Population. Only those participants available at the specified time points were analyzed.||Liters per minute||Standard Error|Least Squares Mean
756448|NCT00603382|Secondary|Mean Change From Baseline in Daily Trough (Pre-dose and Pre-rescue Bronchodilator) Evening Peak Expiratory Flow (PEF) Averaged Over the 8-week Treatment Period|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Trough PEF is defined as the PEF measurement performed at the end of the dosing interval. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. The best of three attempts was recorded by the participants in a daily diary. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the value of the averaged daily evening PEF over the 8-week treatment period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of Baseline trough evening PEF, country, sex, age, and treatment group.|From Baseline up to Week 8|ITT Population. Only those participants available at the specified time points were analyzed.||Liters per minute||Standard Error|Least Squares Mean
756449|NCT00603382|Primary|Mean Change From Baseline in Trough (Evening Pre-dose and Pre- Rescue Bronchodilator) FEV1 at Week 8|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. Pre-dose and pre-rescue bronchodilator (albuterol/salbutamol) trough FEV1(the measurement of FEV1 performed at the end of the dosing interval) was measured electronically by spirometry in the evening at the Baseline through Week 8 clinic visits. Trough FEV1 is the FEV1 measured approximately 24 hours after the last administration of study drug. The highest of 3 technically acceptable measurements was recorded. The Visit 3 FEV1 assessment was used as the Baseline value. Change from Baseline in trough FEV1 was calculated as the value at Week 8 minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of Baseline trough FEV1, country, sex, age, and treatment group.|Baseline and Week 8|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study medication. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-BL on-treatment measurement (scheduled and unscheduled visits) was used to impute missing measurements.||Liters||Standard Error|Least Squares Mean
756450|NCT00594958|Secondary|SCR for Anti-JEC Neutralizing Antibody Titer||day 56||||||
756451|NCT00594958|Secondary|Safety|Safety laboratory parameters, rate of SAEs and medically attended AEs, systemic and local tolerability|study duration||||||
756452|NCT00594958|Primary|GMT for Anti-JEV Neutralizing Antibody|Equivalence between batches with regards to GMT (Geometric Mean Titer) was postulated if all three pair-wise 95 % Confidence Intervals for GMT ratios were between 0.5 and 2.|day 56|Per Protocol Population (observed values)||GMT||95% Confidence Interval|Geometric Mean
756456|NCT00595075|Other Pre-specified|Post Nap Assessment - Digit Symbol Substitution Test (Correct Answers)|A cognitive throughput task consisting of matching symbols to numerical keys; higher numbers indicate a better score|71 minutes|All participants that completed both crossover periods||correct answers||Standard Deviation|Mean
756457|NCT00595075|Other Pre-specified|Post Nap Assessment - Karolinska Sleepiness Scale|numerical scale of increasing sleepiness from 1-9 (higher values indicate worse outcome)|71 minutes|All participants that completed both crossover periods||units on a scale||Standard Deviation|Mean
756458|NCT00595075|Other Pre-specified|Post-nap Assessment - Visual Analog Scale|numerical scale of increasing alertness from 0-100 (higher values are better outcome)|71 minutes|All participants that completed both crossover periods||units on a scale||Standard Deviation|Mean
756459|NCT00595075|Primary|Sleep Efficiency|total sleep time/time in bed * 100% (higher values indicate better outcome)|2 hours|All participants that completed both crossover periods||percent||Standard Deviation|Mean
756460|NCT00595088|Secondary|Safety|the incidence and severity of adverse events|9 weeks|||percentage of participants|||Number
756461|NCT00595088|Secondary|Ablative Effect on a Marker Tumor|Complete disappearance of marker lesion|9 weeks|||percentage of participants||90% Confidence Interval|Number
756462|NCT00595088|Secondary|Time to Tumor Recurrence|The Time to Tumor Recurrence is defined as the interval between the date of the final tumor resection before the start of study treatments to the date when the cystoscopy was performed in which it was confirmed by histopathology that any suspicious lesions that were observed, were TCC of the bladder with the exception of the continued presence of the marker tumor at Week 9|46 Weeks|||months||Full Range|Median
756463|NCT00595088|Primary|Complete Tumor Response Defined as the Absence of New Tumors|Tumor response evaluated at week 9 (range 8-10 weeks) during the first post induction course treatment cystoscopy or TUR of suspiciaous lesions|9 Weeks|All patients who met the study inclusion and exclusion criteria; received all 6 of the induction course intravesical administrations of the investigational product; and had a follow-up cystoscopy during Weeks 8 to 10 and biopsy or TUR of suspicious lesions||percentage of participants||90% Confidence Interval|Number
756464|NCT00595114|Primary|8-isoprostane Levels as Biochemical Markers for Nonenzymatic Oxidative Stress in Asthma|8-isoprostane levels in sputum|Measured at completion of sample analysis|||pg/ml||Standard Deviation|Mean
756465|NCT00595127|Primary|Incidence & Quality of Engraftment & Hematopoietic Reconstitution|Number of patients who engrafted|8 years|||participants|||Number
756466|NCT00595153|Primary|Gene Expression in Airway Secretions and Tissues|The primary outcome measure for this study is the scaled mean value of three gene expression markers of IL-13 in the airway: PERIOSTIN, calcium-activated chloride channel regulator 1 (CLCA1), and plasminogen activator inhibitor-2 (SERPINB2). First, for each of the three interleukin-13 (IL-13) signature genes, the log (base-2) transformed relative expression value for each subject is measured using real-time polymerase chair reaction (PCR) and normalized with the geometric mean of 5 housekeeping genes. Next, these values are centered (by subtracting the mean for that gene) and scaled (by dividing by the standard deviation for that gene) so that each gene makes an equal, assay-independent contribution to the Th2 phenotype. Then, for each subject, the arithmetic mean of the three centered & scaled genes is calculated, producing the “three-gene-mean” metric.|Healthy Control: Visit 2 (at 1 week); Steroid Naive Asthmatics: Visit 2 (at 1 week); Steroid Treated Asthmatics: Visit 5 (at 9 weeks)|"Participants who met inclusion/exclusion requirements and completed all study activities were included in the analysis. Specifically, this included:
1. Having a bronchoscopy with complete PCR on RNA from epithelial brush samples."||Relative gene expression level||Standard Deviation|Mean
756467|NCT00595270|Secondary|Safety Profile of IC51||study duration||||||
756468|NCT00595270|Secondary|GMT 1month After Booster Doses||1 month||||||
756469|NCT00595270|Secondary|SCR 1 Month After the Booster Doses||1 month||||||
756470|NCT00595270|Secondary|Persistent and Actual GMT 6, 12 and 24 Months After Primary Vaccination||24 months||||||
756471|NCT00595270|Secondary|Persistent and Actual SPR 6, 12 and 24 Months After Primary Vaccination||- 24 months||||||
756472|NCT00595270|Secondary|SPR 24 Months After the Primary Vaccination (Observed)|"Persistence of immunogenicity (SPR) at M24 (observed) defined as :
positive (persistent): Subjects
with a non-missing, positive seroconversion at D56 (Study IC51-304), and
who did not receive a booster dose at Visit 2 (M11) or Visit 4 (M23), and
with a non-missing, SP positive PRNT50 result at Visit 1 (M6) or Visit 3 (M12), and
with a non-missing, SP positive PRNT50 result at Visit 5 (M24)
negative (non-persistent): Subjects
with missing or negative seroconversion at D56 (Study IC51-304), or
who did receive a booster dose at Visit 2 (M11) or at Visit 4 (M23), or
with a non-missing, SP negative PRNT50 result at Visit 1 (M6) or Visit 3 (M12), or
with a missing PRNT50 result at both Visit 1 (M6) and Visit 3 (M12), or
with a non-missing, SP negative PRNT50 result at Visit 5 (M24)"|24 months||||||
756473|NCT00595270|Primary|Long Term Immunogenicity of IC51 Vaccine 24 Months After the Primary Vaccination|"Seroprotection rate (SPR) (anti-JEV neutralizing antibody titer ≥ 1:10) 24 months (M24) after the primary vaccination - imputed; Persistence of immunogenicity (SPR) at M24 defined as:
pos. (positive) (persistent): Subjects
with a non-missing, pos. seroconversion at D56 (Study IC51-304) and
without booster at M11 or M23 and
with non-missing, seroprotection (SP) pos. PRNT50 at M6 or M12 and
with non-missing, SP pos. PRNT50 at M24
neg. (negative) (non-persistent): Subjects with
missing or neg. seroconversion at D56 (Study IC51-304) or
booster at M11 or at M23, or
non-missing, SP neg. PRNT50 at M6 or M12 or
missing PRNT50 at both M6 and M12 or
missing or SP neg. PRNT50 (serum dilution giving 50% reduction in plaques in a Plaque Reduction Neutralization Test) at M24"|- 24 months|ITT (Intent-To-Treat) Population: included all subjects rolled over from study IC51-304; analyzed according to treatment to which they were randomized in IC51-304||percentage of participants||95% Confidence Interval|Number
756474|NCT00595309|Secondary|Geometric Mean Titer||D28, Month 6 and Month 12 after booster||||||
756475|NCT00595309|Secondary|Seroconversion||at D28 and Month 6 after booster||||||
756476|NCT00595309|Secondary|Safety and Adverse Events||up to Month 12 after booster||||||
756477|NCT00595309|Primary|Seroconversion Rate||at Month 12 after booster|Intent-To-Treat Population which includes all subjects entered into the study who received the booster vaccination||percent||95% Confidence Interval|Number
757005|NCT00605280|Secondary|Number of Participants With a ≥ 15 Letter Improvement in Vision at 1 Year|Refraction and best-corrected VA measurements were performed using retro-illuminated, modified Ferris-Bailey ETDRS charts|Baseline, Year 1|MITT1 population. LOCF.||Participants|||Number
756478|NCT00595335|Secondary|Failure Rate at One Year|The failure rate was defined as a composite variable of CAS decrease of < 2 points or need for additional therapy (excluding cosmetic surgery) for the eye disease.|one year|Analysis was intent to treat. The last observation was carried forward from the subjects who dropped out before (or at) 52 weeks.||percentage of participants|||Number
756479|NCT00595335|Secondary|Graves' Ophthalmopathy Quality of Life Score Using the Short Form-12 (SF-12) Health Survey|Quality of life (QoL) was measured by the SF-12 questionnaire. The SF-12 is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey. Physical and Mental Health Composite Scores are computed (combined, scored, and weighted) using the scores of the 12 questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. Improvement was defined as a change of ≥ 6 points.|baseline, 6 months after first infusion, 12 months after first infusion|||units on a scale||Inter-Quartile Range|Median
756480|NCT00595335|Secondary|Change in Extraocular Motility|"Change extraocular motility was assessed using the Gorman diplopia score. Diplopia, commonly known as double vision, is the simultaneous perception of two images of a single object that may be displaced horizontally, vertically, or diagonally (i.e., both vertically and horizontally) in relation to each other. It is usually the result of impaired function of the extraocular muscles, where both eyes are still functional but they cannot converge to target the desired object.
The Gorman diplopia score includes four categories: 1) no diplopia (absent), 2) diplopia when the patient is tired or awakening (intermittent), 3) diplopia at extremes of gaze (inconstant), and 4) continuous diplopia in the primary or reading position (constant)."|baseline, 6 months after first infusion, 12 months after first infusion|Intention to treat analysis||units on a scale||Inter-Quartile Range|Median
756481|NCT00595335|Secondary|Change in Lid Fissure|"The palpebral fissure is the elliptic space between the medial and lateral canthi of the two open eye lids. In adults, this measures about 10mm vertically and 30mm horizontally. The fissure may be increased in vertical height in Graves' disease.
Improvement was defined as a decrease in lid aperture width by ≥3 mm."|baseline, 6 months after first infusion|Intention to treat analysis||mm||Inter-Quartile Range|Median
756482|NCT00595335|Secondary|Change in Proptosis|Eye proptosis is a condition resulting in forward displacement of the globe from its normal position within the orbit. It is measured by computed tomography. Improvement in proptosis was defined as a decrease in proptosis by ≥2 mm.|baseline, 12 months after first infusion|||mm||Standard Deviation|Mean
756483|NCT00595335|Secondary|Change in Disease Severity|Disease severity was measured by the NOSPECS Score. This classification scheme of the eye changes in thyroid eye disease was introduced by the American Thyroid Association. It separates patients into seven classes of disease (class 0–6), with 0 being no signs or symptoms and 6 being sight loss. (The acronym is based on the first letter of the defining characteristic of each class, the classification is known as: ‘no signs or symptoms; only signs; soft tissue; proptosis; extraocular muscle; cornea; sight loss’ (NOSPECS) ).|baseline, 6 months after first infusion|Intention to treat analysis||participants|||Number
756484|NCT00595335|Secondary|Failure Rate|The failure rate was defined as a composite variable of CAS decrease of < 2 points or need for additional therapy (excluding cosmetic surgery) for the eye disease.|6 months after first infusion, 12 months after first infusion|Analysis was intent to treat. The last observation was carried forward from the subjects who dropped out before (or at) 24 weeks.||percentage of participants|||Number
756485|NCT00595335|Primary|Change in Clinical Activity Score (CAS)|The clinical activity score (CAS), for Grave's ophthalmopathy has become a widely accepted tool to assess disease activity and help decide the management of the condition. The CAS, which is based on classical signs of inflammation (pain, redness, and swelling), consists of 7 equally weighted items. The total CAS (as used in this study) may range from 0 to 7. The higher the CAS, the greater degree of inflammation is present. A drop in CAS of 2 or more points suggests an improvement in the inflammatory components of the disease. A CAS ≥3 implies active disease.|baseline, 6 months after the first infusion|Sample size was computed based on the expected drop of 2.9 and 1.5 points in the CAS score in rituximab and placebo groups. A sample size of 15 in each group will have 80% power to detect a difference in mean values of 1.4 assuming that the common standard deviation is 1.27 using a two group t-test with a 0.050 two-sided significance level.||units on a scale||Standard Deviation|Mean
756486|NCT00595361|Secondary|Comparison of the Maximum Percent Fall in FEV1 After 1st Dose of Salmeterol to the End of the 2-week Treatment Period Between Arg/Arg and Gly/Gly Subjects||2 weeks after 1st dose of Salmeterol|||% fall FEV1||Standard Deviation|Mean
756487|NCT00595361|Secondary|Comparison of the Maximum Percent Fall in FEV1 From Pre-salmeterol Baseline to the End of the 2-week Treatment Period Between Arg/Arg and Gly/Gly Patients||2 weeks from pre-salmeterol baseline|||% fall FEV1||Standard Deviation|Mean
756488|NCT00595361|Primary|Comparison of the Maximum Percent Fall in FEV1 After Exercise Challenge at the End of the 2-week Treatment Period Between Arg/Arg and Gly/Gly Patients||2 weeks after exercise challenge|||% fall FEV1||Standard Deviation|Mean
756489|NCT00595413|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs|An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.|From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38|ITT population included all randomized participants who received at least 1 study treatment dose.||participants|||Number
756490|NCT00595413|Secondary|Percentage of Participants With Good or Moderate European League Against Rheumatism (EULAR) Responses at Week 26|The EULAR response criteria evaluate change in DAS28 scores represented as “good response”, “moderate response”, or “no response” considering both the current DAS28 score and the observed improvement from baseline. Participants were considered to have “good” or “moderate” EULAR response if at the time of assessment, their DAS28 score was less than or equal to (<=) 5.1 and the improvement from baseline in their DAS28 score was greater than (>) 0.6; or if at the time of assessment, their DAS28 score was >5.1 and improvement from baseline in their DAS28 score was >1.2.|Week 26|ITT population included all randomized participants who received at least 1 study treatment dose.||percentage of participants|||Number
786171|NCT00833690|Secondary|Change in Serum Urate|Change from an Average of Baseline and Screening Visits|Visit 07 from Baseline (i.e., between -45 days and +9 months)|||mg/dL||Standard Deviation|Mean
756491|NCT00595413|Secondary|Percentage of Participants Achieving American College of Rheumatology 70 Response Based on CRP (ACR70-CRP) at Week 26|ACR70-CRP response is defined as >=70% improvement from Baseline in both tender joint counts (based on a total of 68 joints) and swollen joint counts (based on a total of 66 joints) together with >=70% improvement from Baseline in at least 3 of the following 5 measures: 1) participant's assessment of pain; 2) participant's global assessment of disease activity; 3) physician's global assessment of disease activity; 4) participant's assessment of physical function; and 5) acute-phase marker (CRP).|Week 26|ITT population included all randomized participants who received at least 1 study treatment dose.||percentage of participants|||Number
756492|NCT00595413|Secondary|Percentage of Participants Achieving American College of Rheumatology 50 Response Based on CRP (ACR50-CRP) at Week 26|ACR50-CRP response is defined as >=50% improvement from Baseline in both tender joint counts (based on a total of 68 joints) and swollen joint counts (based on a total of 66 joints) together with >=50% improvement from Baseline in at least 3 of the following 5 measures: 1) participant's assessment of pain; 2) participant's global assessment of disease activity; 3) physician's global assessment of disease activity; 4) participant's assessment of physical function; and 5) acute-phase marker (CRP).|Week 26|ITT population included all randomized participants who received at least 1 study treatment dose.||percentage of participants|||Number
756493|NCT00595413|Primary|Percentage of Participants Achieving American College of Rheumatology 20 Response Based on C-reactive Protein (ACR20-CRP) at Week 26|ACR20-CRP response is defined as greater than or equal to (>=) 20 percent (%) improvement from Baseline in both tender joint counts (based on a total of 68 joints) and swollen joint counts (based on a total of 66 joints) together with >=20% improvement from Baseline in at least 3 of the following 5 measures: 1) participant's assessment of pain; 2) participant's global assessment of disease activity; 3) physician's global assessment of disease activity; 4) participant's assessment of physical function; and 5) acute-phase marker (CRP).|Week 26|ITT population included all randomized participants who received at least 1 study treatment dose.||percentage of participants|||Number
756494|NCT00595465|Secondary|Safety and Adverse Events||Day 56||||||
756495|NCT00595465|Secondary|Seroconversion Rate||Day 56||||||
756496|NCT00595465|Primary|Geometric Mean Titer (GMT) for Anti-JEV Neutralizing Antibody||Day 56|Per Protocol Population (PP Population, N= 364): includes all subjects randomized who received at least one dose of study medication without any major protocol violations identified at the blind data review meeting.||titers||Standard Deviation|Mean
756497|NCT00595504|Primary|Change in Abdominal Fat (DEXA).|A comparison between the ramelteon group and the placebo group of change in abdominal fat measured by a DEXA scan, assessed at Baseline and Week 8.|Baseline and Week 8|The number of participants for analysis (intent to treat) were those that completed the study.||g||Standard Deviation|Mean
756498|NCT00595504|Primary|Change in Insulin Resistance as Measured by the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR).|A comparison between the ramelteon group and the placebo group of change in insulin resistance measured by the homeostatic model assessment of insulin resistance (HOMA-IR), assessed at Baseline and Week 8.|Baseline and Week 8|The number of participants for analysis (intent to treat) were those that completed the study.||HOMA score||Standard Deviation|Mean
756499|NCT00595504|Primary|Change in Waist Circumference|A comparison between the ramelteon group and the placebo group in change in waist circumference (measured in cm) measured at Baseline and Week 8.|Baseline and Week 8|The number of participants for analysis (intent to treat) were those that completed the study.||cm||Standard Deviation|Mean
756500|NCT00595517|Primary|Number of Participants Without Gastric and/or Duodenal Ulcer Throughout the Treatment Period||up to 52 weeks|||Participants|||Number
756501|NCT00595517|Secondary|Number of Participants Without Gastric and/or Duodenal Ulcer up to 24 Weeks After Treatment||up to 24 weeks after treatment|||participants|||Number
756502|NCT00595517|Secondary|Number of Participants Without Gastric and/or Duodenal Ulcer up to 12 Weeks After Treatment||up to 12 weeks after treatment|||participants|||Number
756503|NCT00595517|Secondary|Number of Participants Without Gastric and/or Duodenal Ulcer up to 4 Weeks After Treatment||up to 4 weeks after treatment|||Participants|||Number
756504|NCT00595530|Secondary|Self-reported Pain Scores||Every 4 hours||||||
756505|NCT00595530|Secondary|Intravenous Opiate Utilization||Every 4 hours||||||
756506|NCT00595530|Primary|The Number of Participants That Experience Side Effects|How many participants experienced side effects while undergoing treatment with the study drug?|Daily while inpatient and once a week for first 4 weeks post discharge|||participants|||Number
756507|NCT00595556|Secondary|Change in Gamma-glutamyl Transferase (GGT) Concentration|This outcome measure looks at the change in blood levels of this enzyme assay from baseline, and then after 6 weeks (midpoint), and then at the endpoint (12 weeks). The analysis takes into account all three time points, and reports the average change between each of the three time points.|12 weeks (from initiation to end of treatment)|||Units/Liter||Standard Deviation|Mean
756508|NCT00595556|Secondary|Change in the Urge to Drink Alcohol as Measured by the Alcohol Urge Questionnaire (AUQ)|This is the change in measured urge to drink alcohol as measured by the Alcohol Urge Questionnaire (AUQ), measured every 2 weeks from baseline until the last week of the study (over twelve weeks, 7 timepoint measurements of AUQ, 6 calculated changes). It is reported in terms of change per visit (every 2 weeks). AUQ measures a feeling state, and uses a 7 point (1-7)Likert scale for each of 8 items (questions). The lowest urge score is 8 (representing less urge to drink), and the highest would be tabulated as 56 (meaning more urge to drink). Repeated measures SPPS linear mixed models used.|baseline to the end of 12 weeks in treatment|||units on a scale/visit||Standard Deviation|Mean
756509|NCT00595556|Secondary|Change in Number of Drinks Per Week by Week|This outcome measure represents the change in the total number of standard drinks per week (weekly data) from baseline to the end of week twelve. This was analyzed using weekly measurements from baseline to week 12 week of the study period (thirteen time points, 12 measurements)with a repeated measures analysis (SPSS linear mixed models), by interaction with time (week).|baseline to the end of 12 weeks in treatment|The analysis was intention to treat and last observation carried forward||drinks/week||Standard Deviation|Mean
756510|NCT00595556|Primary|Weekly Rate of Change in Abstinent Days|This outcome measure analyzed the weekly rate of change in number of abstinent days over the twelve weeks of the study from baseline to the end of week twelve. This was analyzed using weekly measurements over the 12 week study period (thirteen time points, 12 measurements)with a repeated measures analysis (SPSS proc mixed), by interaction with time (week).|baseline to the end of 12 weeks in treatment|||days/week||Standard Error|Mean
756511|NCT00595556|Primary|Change in Number of Heavy Drinking Days (i.e., 5 or More Drinks Per Day for Men, and 4 or More Per Day for Women)Per Week, by Week|This outcome measure represents the change in number of heavy drinking days (i.e., 5 or more drinks per day for men, and 4 or more per day for women)per week, from baseline to the end of week twelve. This was analyzed using weekly measurements over the 12 week study period (thirteen time points, 12 measurements)with a repeated measures analysis (SPSS linear mixed models), by interaction with time (week).|baseline to the end of 12 weeks in treatment|||Days/week||Standard Deviation|Mean
756512|NCT00595582|Primary|Neuropsychological Scores in Patients With MCI or Mild AD.||within the next three years|No data were collected as this study was terminated.||units on a scale||Standard Deviation|Mean
756513|NCT00595764|Secondary|Overall Health- Short Form (36) Health Survey|"Short Form (36) Health Survey overall score ranges from 0 to 100. Computed as the mean of all SF-36 subscales.
The SF-36 is a multi-purpose, short-form health survey with only 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. Lower scores are greater disability and higher scores are greater health functioning."|6 months|All participants who completed 1 or more SF-36 assessments were included in the analysis.||Scores on a scale||Standard Error|Mean
756514|NCT00595764|Secondary|Criminal Activity- Addiction Severity Index (ASI) Legal Composite Score.|The ASI Legal Composite score ranges from 0 to 1 with higher scores corresponding to greater legal problems.|6 months|All participants who completed one or more ASI assessments were included in the analysis.||Scores on a scale||Standard Error|Mean
756515|NCT00595764|Secondary|Cocaine Abstinence|Total weeks of cocaine abstinence as documented by weekly urine toxicology analysis. Range from 0 to 24.|6 months|All participants provided one or more urine screens thus data was based on all participants.||weeks of abstinence||Standard Deviation|Mean
756516|NCT00595764|Secondary|Treatment Completion|The number of patients who completed the study (did not meet the criteria for protective transfer baseed on drug use, did not miss medication for more than seven days, or did not miss three or more Physician Management sessions) at 24 weeks.|6 months|All participants who entered treatment were evaluated for treatment completion.||participants|||Number
756517|NCT00595764|Primary|Illicit Opioid Abstinence|number of weeks of abstinence from illicit opioids, as documented by urine toxicology and self-report. Range 0 - 24.|6 months|Repeated measures analysis of variance was used to evaluate differences between groups in the maximum number of consecutive weeks of opioid abstinence for the first and second 12 weeks of treatment. We coded missing urine specimens as positive for opioids in our analysis, thus all participants provided data.||Weeks of Abstinence||Standard Deviation|Mean
756518|NCT00595790|Secondary|Safety|AEs, Local and systemic tolerability, Safety laboratory parameters|Study duration||||||
756519|NCT00595790|Secondary|GMT at Day 10, 28, 35 and 56||Day 10, 28, 35 and 56||||||
756520|NCT00595790|Secondary|SCR at Day 10, 28 and 35||Day 10, 28 and 35||||||
756521|NCT00595790|Primary|SCR (Seroconversion Rate) at Day 56|Seroconversion rate: percentage of subjects with >= 1:10 anti-JEV neutralizing antibody titer|day 56|The Participant Flow shows all study participants randomized. The Primary Outcome is based on the Per-Protocol-Population (all randomized subjects without major protocol deviation||percentage of participants||95% Confidence Interval|Number
756522|NCT00595868|Secondary|7 Day Point Prevalent Abstinence Verified by Breath Carbon Monoxide of Less Than 10 Parts Per Million|7 day point prevalent abstinence 6 months after enrolling in the study was determined by two steps: (1) A report of no days of smoking for the 7 days prior to the 6 month on the Time Line Follow Back obtained at a telephone call 6 months after enrollment; (2) Those who reported no smoking for the prior 7 days came to our lab for breath carbon monoxide (CO) measurement to confirm abstinence. Breath CO had to be less than 10 parts per million for the participant to be classified as abstinent.|6 months|||participants|||Number
756523|NCT00595868|Primary|Number of Participants With a Quit Attempt|A quit attempt was defined as a self-reported attempt to quit smoking on a given day reported on a Time Line Follow Back (TLFB) obtained at each visit for the first 2 months and via monthly phone calls during months 3-6. The TLFB collected information for each day since the previous visit/call on number of cigarettes smoked that day, whether medication (varenicline or placebo) was used that day, and whether a quit attempt occured that day.|6 months|||participants|||Number
756524|NCT00595881|Primary|Sensitivity and Specificity of Bedside Emergency Ultrasound When Added to the Clinical Examination Compared With Clinical Examination Alone.|The sensitivity and specificity of clinical examination with the addition of bedside emergency ultrasound will be compared against that of clinical examination alone.The number of lesions determined to actually have a drainable fluid collection will serve as the denominator in the calculation of sensitivity, and the number of lesions correctly identified as having a drainable fluid collection by clinical exam plus ultrasound and clinical exam alone, respectively, will serve as the numerator.The number of lesions determined to not have a drainable fluid collection will serve as the denominator in the calculation of specificity, and the number of lesions correctly identified as not having a drainable fluid collection by clinical exam plus ultrasound and clinical exam alone, respectively, will serve as the numerator. Significance will be defined as a 95% confidence interval surrounding the differences between the two groups for sensitivity and specificity that does not include 0.|18 mos|Assuming a baseline sensitivity of clinical exam alone similar to that previously published (86%), type 1 error rate 0.05, and intraclass correlation coefficient of 0.5 for lesions within patients, we estimated a sample size of 393 lesions would provide 80% power to detect at least a 9% difference in the sensitivity of CE+EUS compared to CE alone.||Ratio as a percentage||95% Confidence Interval|Number
756525|NCT00595920|Secondary|Evaluate Changes in Annualized Relapse Rate||Annually||||||
756526|NCT00595920|Secondary|Evaluate Changes in Rate and Severity of Multiple Sclerosis (MS) Progression||Annually||||||
756591|NCT00596752|Secondary|Cardiovascular Mortality During the Course of the Study (up to 196 Days)||During the course of the study (up to 196 days)|Safety Set consists of all randomized subjects who received at least one dose of trial medication.||participants|||Number
756527|NCT00595920|Primary|Evaluate Changes in Number of Combined Unique Active Lesions on Brain Magnetic Resonance Imaging (MRI)|This extension study was discontinued due to financial constraints of the company. Of the 38 patients dosed, 32 did not complete all 5 doses. Of the 6 patients that completed the 5 doses, 5 patients did not have a Wk 52 MRI and therefore, no efficacy results are summarized as there is no comparison data.|Annually|This extension study was discontinued due to financial constraints. No efficacy results are summarized due to the small number of patients who received full treatment and follow-up.|||||
756528|NCT00595946|Secondary|Treatment Effectiveness (Patient Reported Outcome)|Treatment effectiveness scores were collected at the end of each treatment week during the study; the number of participants analyzed reflects those subjects who provided at least one end-of-week assessment of treatment effectiveness. For the analysis, treatment effectiveness scores were averaged across the treatment period (Weeks 1-12). Treatment effectiveness scale: 0 = not at all effective, 1 = a little bit effective, 2 = moderately effective, 3 = quite a bit effective, 4 = extremely effective.|Weeks 1-12|||units on a scale||Standard Deviation|Mean
756529|NCT00595946|Secondary|Mean Changes From Baseline in Straining, Stool Consistency, Constipation Severity, Abdominal Bloating, Abdominal Discomfort, and Bowel Habit Regularity|Ratings over 12-week treatment period were averaged and difference from baseline score calculated; Straining scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe; Stool consistency scale: 0 = very loose, 1 = loose, 2 = normal, 3 = hard, 4 = very hard (little balls); Constipation severity scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe; Abdominal bloating scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe; Abdominal discomfort scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe; Bowel habit regularity scale: 7-point scale, where 1 = very regular and 7 = very irregular.|Weeks 1-12|||units on a scale||Standard Deviation|Mean
756530|NCT00595946|Secondary|Responder Rate|Number of participants, who remained on treatment for at least 8 weeks, and reported response (>=3 SBMs) for at least 50% of weeks on study.|Up to 12 weeks|||participants|||Number
756531|NCT00595946|Secondary|First Post-dose Spontaneous Bowel Movement|The number of participants that experienced first post-dose Spontaneous Bowel Movement at 24 and 48 hour of dose initiation.|24 and 48 hours post-dose|||participants|||Number
756532|NCT00595946|Secondary|Change From Baseline in Mean Weekly Spontaneous Bowel Movement Frequency|Average weekly Spontaneous Bowel Movement frequency rating was calculated from data collected from Week 1-12|Baseline, Week 12, and Weeks 1-12|||Spontaneous Bowel Movements/Week||Standard Deviation|Mean
756533|NCT00595946|Primary|Change From Baseline in Mean Weekly Spontaneous Bowel Movement Frequency|Outcome analyzed for subjects without dose reduction prior to Week 8, per protocol-specified primary outcome.|Baseline and Week 8|||Spontaneous Bowel Movements/Week||Standard Deviation|Mean
756534|NCT00595959|Secondary|Volumetric Plaque Reduction|Volumetric plaque reduction immediately after treatment with the CLiRpath® Photoablation Atherectomy System as determined by IVUS. Actual volume of plaque present is presented for each measurement point.|measured at time of procedure|Per protocol||millimeters cubed||Standard Deviation|Mean
756535|NCT00595959|Secondary|Adverse Events|Adverse events during procedure and prior to release from the hospital, at 30 days, six (6) months, and 12 months post-procedure.|Through 12 Months|||events|||Number
756536|NCT00595959|Secondary|Rutherford Classification|Rutherford Classification at 30 days, six (6) and 12 months post-procedure. Physician assessed based on ankle pressures and treadmill testing. Rutherford scale: 0=best, 6=worst|Through 12 Months|63 at baseline; 62 at 30days and 6 months; 63 at 12 months||units on a scale of 0-6||Standard Deviation|Mean
756537|NCT00595959|Post-Hoc|Walking Impairment Questionare (WIQ)|Measures difficulty in walking before and after treatment. Defined by comparing the responses to a WIQ at pre-treatment with the responses at 30 days, six (6) months and 12 months post-procedure. Higher score is better (scale 0-100).|measured at each follow-up period|65 patients at baseline and 30 days; 64 at 6 mo; 63 at 12 mo||units on a scale 0-100||Standard Deviation|Mean
756538|NCT00595959|Secondary|Patients With >50% Stenosis Measured by Duplex Ultrasound|Percentage of patients with >50% stenosis at each follow-up (30 days, six months, and 12 months post-procedure).|Through 12 Month|per protocol; 65 patients at 30 days; 59 at 6 months and 46 at 12 months||percent of patients|||Number
756539|NCT00595959|Secondary|Assisted Secondary Patency|Incidence of freedom from assisted secondary patency at 30 days, six (6) and 12 months post-procedure, defined as a re-intervention of a reocclusion (non-patent vessel) at the treatment site|Through 12 Month|65 at 30 days; 64 at 6 months; 63 at 12 months||% pts free from secondary patency|||Number
756540|NCT00595959|Secondary|Assisted Primary Patency|Incidence of freedom from assisted primary patency at 30 days, six (6) and 12 months post-procedure, defined as a re-intervention of a stenosis (patent vessel) at the treatment site to prevent reocclusion|Through 12 Months|65 at 30 days; 64 at 6 months; 63 at 12 months||% pts free from assisted primary patency|||Number
756541|NCT00595959|Secondary|Clinical Success|Clinical success, defined as primary patency (≤ 50% stenosis at the treatment site), as assessed by duplex Doppler ultrasound at 30 days, six (6) months and 12 months post-procedure|measured post discharge thorugh 12 Months follow-up|65 patients at 30 days; 59 at 6 months; 46 at 12 months||percent of patients|||Number
756542|NCT00595959|Secondary|Minimum and Maximum Lumen Diameters|Minimum and maximum lumen diameters immediately after treatment with the CLiRpath® Photoablation Atherectomy System as determined by Intravascular Ultrasound (IVUS).|measured at time of procedure|Analysis per protocol||millimeters||Standard Deviation|Mean
756543|NCT00595959|Secondary|Procedural Success|Acute procedural success, defined as achievement of </= 30% final residual stenosis, as visually assessed by angiography after all adjunctive treatment(s) deemed necessary by the treating physician. Measures % of patients who achieved a final residual stenosis of </=30%.|measured at time of procedure|Per protocol. All enrolled patients||percent with </=30% RS|||Number
756544|NCT00595959|Primary|Major Adverse Events|The primary safety endpoint is the occurrence of major adverse events defined as clinical perforation, major dissection requiring surgery, major amputation, cerebrovascular accidents (CVA), myocardial infarction, and death.|From discharge through the 6 month follow-up|||events|||Number
756545|NCT00595959|Primary|Laser Success|The primary efficacy endpoint is laser success, defined as achieving >/= 20% average reduction in the percent (%) diameter stenosis, post-laser and prior to adjunctive therapy, based on angiographic core laboratory assessment.|Measured at time of procedure|Per protocol||percent reduction||Standard Deviation|Mean
756553|NCT00596102|Secondary|Adverse Events||6, 12, 24, 36, 48 and 60 months after 1st vaccination||||||
756554|NCT00596102|Secondary|Geometric Mean Titers||6, 12, 36, 48 and 60 months||||||
756555|NCT00596102|Secondary|Percentage of Subjects With Seroconversion Rate (SCR) ≥ 1:10 Anti-JEV Neutralizing Antibody Titer (PRNT)||6, 12, 36, 48 and 60 months after 1st vaccination||||||
756556|NCT00596102|Primary|Percentage of Subjects With Seroconversion Rate (SCR) ≥ 1:10 Anti-JEV Neutralizing Antibody Titer (PRNT)|first vaccination refers to 1st vaccine administration in studies IC51-301 or IC51-302|24 months after the first vaccination|subjects enrolled into this study who planned to participate in the long-term immunogenicity part and received IC51 in the respective preceeding study||percentage of subjects||95% Confidence Interval|Number
756557|NCT00596167|Primary|Intradialytic Clearance of Levofloxacin, Gentamicin and Vancomycin in Patients Receiving Short-daily Hemodialysis|"The intradialytic clearance of levofloxacin, gentamicin and vancomycin will be determined in patients receiving short-daily hemodialysis.
(Of important note, due to technical issues the levofloxacin data was not able to be used for the analysis. Only the gentamicin and vancomycin data was analyzed.)"|Serum concentrations for each drug will be determined from blood samples at 0 (pre-infusion), 30, 60 minutes (end of infusion).|||ml/min||Full Range|Median
756558|NCT00596271|Primary|GMT for Hepatitis A Virus (HAV) Antibody at Day 28||Day 28|||titers||95% Confidence Interval|Geometric Mean
756559|NCT00596271|Secondary|Safety|Rate of Adverse Events (AEs), Serious Adverse Events (SAEs) and medically attended AEs, local and systemic tolerability, changes in safety laboratory parameters (hematology, serum chemistry, urinalysis)|until 6 month after last vaccination||||||
756560|NCT00596271|Secondary|GMT and SCR for PRNT at Day 28 and HAV at Day 56||day 28 and 56||||||
756561|NCT00596271|Secondary|Seroconversion Rate (SCR) at Day 56 for Plaque Reduction Neutralization Assay (PRNT) and HAV at Day 28||day 28 and 56||||||
756562|NCT00596271|Primary|Geometric Mean Titer (GMT) at Day 56 for Anti-JEV Neutralizing Antibodies|"anti-JEV Neutralizing Antibodies were tabulated for IC51 groups only; for HAV GMTs (co-primary endpoint GMT for Hepatitis A Virus (HAV) Antibody at Day 28), please refer to Outcome 2 within outcome measure section"|Day 56|Per Protocol Population includes all randomized subjects without major protocol deviations||titers||95% Confidence Interval|Geometric Mean
756563|NCT00596362|Primary|The Response of Intravitreal Avastin in Causing a Clinically Significant Reduction in Uveal Melanoma Tumor Size (Base Height and Volume).|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response, Disappearance of all target lesions; Partial Response, >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease: neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for partial response nor sufficient increase in the sum of the longest diameter of target lesions to qualify for progressive disease|At conclusion of study, up to 5 days|||participants|||Number
756564|NCT00596427|Secondary|Glucagon AUC|"Changes from baseline of glucagon AUC after 12 weeks of placebo or colesevelam treatment.
AUC values were calculated by the trapezoid method using all results between 0 and 300 minutes"|baseline and 12 weeks|||picograms (pg)/milliter (ml) x min||Standard Error|Mean
756565|NCT00596427|Secondary|Postprandial Fractional Cholic Acid Synthesis|Changes from baseline in fractional cholic acid synthesis after 12 weeks of colesevelam or placebo treatment were evaluated. Fractional cholic acid synthesis represents the relative amount of cholic acid that is made from newly synthesised cholesterol.|baseline and 12 weeks|||Percent new cholic acid||Standard Error|Mean
756566|NCT00596427|Secondary|Fasting Fractional Cholesterol Synthesis|Changes from baseline in fasting fractional cholesterol synthesis after 12 weeks of colesevelam or placebo treatment. Fractional Cholesterol synthesis represents the fraction of free cholesterol in plasma that was newly synthesised.|baseline and 12 weeks|||Percent new cholesterol||Standard Error|Mean
756567|NCT00596427|Secondary|Fasting Fractional De Novo Lipogenesis (DNL)|Changes from baseline in fasting fractional DNL after 12 weeks of colesevelam or placebo treatment were calculated. Fractional DNL represents the fraction of palmitate in very-low density lipoproteins-triglycerides (VLDL-TG) that was newly synthesized.|baseline and 12 weeks|||percent new palmitate||Standard Error|Mean
786172|NCT00833690|Secondary|Change in Serum Urate|Change from an Average of Baseline and Screening Visits|Visit 06 from Baseline (i.e., between -45 days and +6 months)|||mg/dL||Standard Deviation|Mean
756568|NCT00596427|Primary|Rate of Appearance of Exogenous Glucose (Glucose Absorption)|Change from baseline of the rate of appearance of oral glucose after 12 weeks of placebo or colesevelam treatment. Mean of values obtained between 0 and 300 min is reported.|baseline and 12 weeks|||µmol per kg FFM per minute (min)||Standard Error|Mean
756569|NCT00596427|Primary|Fasting Glycogenolysis|Change from baseline of fasting glycogenolysis after 12 weeks of placebo or colesevelam treatment.|baseline and 12 weeks|||µmol per kilograms (kg) FFM per min||Standard Error|Mean
756570|NCT00596427|Primary|Fasting Gluconeogenesis|Change from baseline of fasting gluconeogenesis after 12 weeks of placebo or colesevelam treatment.|baseline and 12 weeks|||micromoles (µmol) per kg FFM per min||Standard Error|Mean
756571|NCT00596427|Other Pre-specified|Glucose AUC|"Changes from baseline of glucose AUC after 12 weeks of placebo or colesevelam treatment.
AUC values were calculated by the trapezoid method using all results between 0 and 300 minutes"|baseline and 12 weeks|||millimoles (mmol)/l x min||Standard Deviation|Mean
756572|NCT00596427|Other Pre-specified|Glycosylated Hemoglobin (HbAlc)|Changes from baseline of HbA1c after 12 weeks of placebo or colesevelam treatment.|baseline and 12 weeks|||percentage||Standard Deviation|Mean
756573|NCT00596427|Primary|Fasting Endogenous Glucose Production (EGP)|Changes from baseline of fasting EGP after 12 weeks of placebo or colesevelam treatment.|baseline and 12 weeks|||umol per kg Fat-Free Mass (FFM) per min||Standard Error|Mean
756574|NCT00596427|Secondary|Total Glucose-dependent Insulinotropic Polypeptide (GIP) AUC|"Changes from baseline of total GIP-1 AUC after 12 weeks of placebo or colesevelam treatment.
AUC values were calculated by the trapezoid method using all results between 0 and 300 minutes"|baseline and 12 weeks|||pmol/l x min||Standard Deviation|Mean
756575|NCT00596427|Secondary|Total Glucagon-like Peptide (GLP-1) Area Under the Curve (AUC)|"Changes from baseline of total GLP-1 AUC after 12 weeks of placebo or colesevelam treatment.
AUC values were calculated by the trapezoid method using all results between 0 and 300 minutes"|baseline and 12 weeks|||picomoles (pmol)/Liter (L) x minute (min||Standard Deviation|Mean
756576|NCT00596440|Secondary|Show Rate at First Treatment Session||week one|This analysis includes only a subset of participants who had not discontinued the study by week 1.||participants|||Number
756577|NCT00596440|Secondary|Smoking Cessation Rate||week nine|The 129 participants represents a subset of the sample that participated in treatment. This subset of participants includes only those who attended eligibility session and participated in the week 9 follow-up. One oncology relative became ineligible immediately following completion of this counseling session and was excluded.||participants|||Number
756578|NCT00596440|Primary|Accrual Rate (Eligibility Visit)|Show rate to eligibility visit|week zero|||participants|||Number
756579|NCT00596453|Primary|PSA Levels (Change in PSA Levels With and Without Antibiotics Therapy)|"We took 4 Prostate Specific Antigen (PSA, ng/mL) measurements per participant. The first PSA test was performed at enrollment. The second PSA test was performed 7 days (+/-3 days) later. Then the participants took the Placebo or Cipro for 14 days. The participants returned for their 3rd PSA test upon completion of the Placebo or Cipro. The final PSA test was performed 7 days (+/-3 days) after the 3rd test.
We planned to compare the differences between the first two PSA tests and the last two PSA tests in the Placebo vs Cipro groups."|1 month post enrollment|||ng/mL||Standard Deviation|Mean
756580|NCT00596466|Primary|Number of Participants With Laboratory Test Values of Potential Clinical Importance|Pre-defined criteria were established for each laboratory test (hematology, blood chemistry and urinalysis) to define the values that would be identified as of potential clinical importance.|Baseline up to Week 28|Safety analysis set population; Number of participants analyzed (N): participants with at least one observation of any given laboratory test while on study.||Participants|||Number
756581|NCT00596466|Primary|Number of Participants With (All Causality) Adverse Events (AEs) and Serious Adverse Events (SAEs)|Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Participants with multiple occurrences of an AE within a category were counted once within the category.|Baseline up to Week 28|Safety analysis set population: all participants who received at least 1 dose of pregabalin.||Participants|||Number
756582|NCT00596466|Primary|Seizure Frequency||Baseline up to Week 28|Not analyzed; Per protocol, seizure frequency data for individual participants were collected and reviewed but no statistical inferences were conducted because there was no comparator agent for this study.|||||
756583|NCT00596622|Secondary|Young Mania Rating Scale|Gold standard scale to measure mania, Range 0 - 60; 12 - 15 mild mania; 15 - 20 moderate mania; >20 severe mania|Baseline and 8 weeks|||units on a scale||Standard Deviation|Mean
756584|NCT00596622|Primary|17-item Hamilton Depression Rating Scale (HDRS)|17-item HDRS is gold standard for measurement of depression with a range from 0 - 52. 10 - 14: mild depression; 14-20 moderate depression; >20: severe and very severe depression.|Measured at Baseline and after 8 weeks of treatment|||units on a scale||Standard Deviation|Mean
756585|NCT00596635|Primary|Number of Urine Cultures Collected Out of the Total Number Expected to be Collected.|Urine cultures were collected at baseline and monthly for six months. The total number of urine cultures collected out of the total number that were expected to be collected are shown.|6 months|||Urine cultures|||Number
756586|NCT00596635|Secondary|Number of Participants With >100,000 Colony Forming Units Per Milliliter of Any Organism Isolated From Urine Culture|Urine cultures were obtained at baseline and monthly for 6 months. If a urine culture had >100,000 colony forming units per milliliter of any organism on any of the urine cultures obtained, the participant is noted as meeting the outcome.|6 months|||Participants|||Number
756587|NCT00596635|Secondary|Number of Participants With E.Coli Isolated From Urine Culture|Urine cultures were obtained at baseline and monthly for six months. Any participant that had E.coli isolated at least once is listed as meeting the outcome.|6 months|||Participants|||Number
756588|NCT00596687|Primary|Mean Blood Glucose Concentration|blood glucose concentration in the intervention groups after second day of treatment to up to 10 days of treatment|hospital stay days 2-10|||mg/dl||Standard Deviation|Mean
756589|NCT00596687|Secondary|# Participants With Hypoglycemic Events|number of participants in the treatment arms with of hypoglycemic events (< 70 mg/dl)|hospital stay days 2-10|||participants|||Number
756590|NCT00596752|Secondary|Cardiovascular Morbidity During the Course of the Study (up to 196 Days)|Cardiovascular morbidity is presented as number of subjects with myocardial infarction and/or stroke during the course of the study.|During the course of the study (up to 196 days)|Safety Set consists of all randomized subjects who received at least one dose of trial medication.||participants|||Number
756593|NCT00596752|Secondary|Revascularization Procedures at 24 Weeks After the End of Study Drug Treatment|The number of subjects with revascularization prior to or at 24 weeks after the end of study drug treatment is presented below.|At 24 weeks after the end of study drug treatment|Of the 838 subjects in the Full Analysis Set (FAS), 577 are included in the analysis of this outcome measure. FAS consists of all randomized subjects who received at least one dose of trial medication and who provide valid data to assess at least one of the primary efficacy endpoints.||participants|||Number
756594|NCT00596752|Secondary|Minor Amputations at 24 Weeks After the End of Study Drug Treatment|"Assessment of amputations was collected per leg affected by a lesion with up to 2 lesions per subject. Amputations were regarded as major if they were performed at the ankle joint level or above. Amputations of toes or part of the foot leaving a stump thereon the subject can walk were regarded as minor. An affected leg is defined as a leg with at least 1 lesion on Study Day -6 to -2 and only amputations of affected legs are considered in the efficacy analysis of amputations. A subject is counted as major/minor amputated, if at least 1 affected leg was major/minor amputated.
The number of subjects with minor amputation prior to or at 24 weeks after the end of study drug treatment is presented below."|At 24 weeks after the end of study drug treatment|Of the 838 subjects in the Full Analysis Set (FAS), 613 are included in the analysis of this outcome measure. FAS consists of all randomized subjects who received at least one dose of trial medication and who provide valid data to assess at least one of the primary efficacy endpoints.||participants|||Number
756595|NCT00596752|Secondary|Systolic Pressure at Ankle Level at 24 Weeks After the End of Study Drug Treatment|Systolic pressure at ankle level was measured at the Arteria tibialis posterior and the Arteria dorsalis pedis. Two individual series of measurements of arterial pressures per subject across the assessed visits were selected for the analysis. For the first analysis (worst change analysis) the series of measurements in the one artery which has the worst change from Baseline at the final measurement was used. For the second analysis (worst value analysis) the series of measurements which has the worst final post-Baseline measurement was used. The series relevant for the analyses was selected from the series for the affected leg or legs only. The selection is 1 out of up to 4 series available per subject. Series without Baseline value and series with at least 1 measurement of more than 150 mmHg were excluded from the selection process due to the suspicion of media sclerosis of the lower limb artery.|At 24 weeks after the end of study drug treatment|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF) in case of missing values. FAS consists of all randomized subjects who received at least one dose of trial medication and who provide valid data to assess at least one of the primary efficacy endpoints.||mmHg||Standard Deviation|Mean
756596|NCT00596752|Secondary|Consumption and Type of Analgesic Medication During the Course of the Study (up to 196 Days)|The number of subjects who used analgesics are summarized for different time points/intervals during the course of the study.|During the course of the study (up to 196 days)|Full Analysis Set (FAS) consists of all randomized subjects who received at least one dose of trial medication and who provide valid data to assess at least one of the primary efficacy endpoints.||participants|||Number
756597|NCT00596752|Secondary|Increase/Decrease in Ulcer Area of ≥ 50 % at 24 Weeks After the End of Study Drug Treatment|In case of two ulcers the worse ulcer status is analyzed. The categories of investigator assessment are: complete healing, decrease by ≥ 50 %, unchanged, increase by ≥ 50 %.|At 24 weeks after the end of study drug treatment|Of the 838 subjects in the Full Analysis Set (FAS), 465 are included in the analysis of this outcome measure. FAS consists of all randomized subjects who received at least one dose of trial medication and who provide valid data to assess at least one of the primary efficacy endpoints.||participants|||Number
756598|NCT00596752|Secondary|Intensity of Rest Pain Induced by Ischemic Lesions at 24 Weeks After the End of Study Drug Treatment|Visit values of intensity of rest pain from a visual analogue scale, ranging from 0 mm (no pain) to 100 mm (maximum conceivable pain), had to be reported in the case of presence of rest pain only. If the leading question in regard to the presence of rest pain is answered with “No“ and no visit value is specified, the visit value will be set to 0 for the analysis.|At 24 weeks after the end of study drug treatment|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF) in case of missing values. FAS consists of all randomized subjects who received at least one dose of trial medication and who provide valid data to assess at least one of the primary efficacy endpoints.||millimeters (mm)||Standard Deviation|Mean
756599|NCT00596752|Secondary|Complete Healing of Ischemic Necroses and Ulcerations at 24 Weeks After the End of Study Drug Treatment|The assessment of ulcer area was collected per lesion with up to 2 lesions per subject (both legs could be affected). In the analysis a subject is only considered completely healed at a time point, if all ischemic lesions are reported as completely healed at that time point.|At 24 weeks after the end of study drug treatment|Of the 838 subjects in the Full Analysis Set (FAS), 568 are included in the analysis of this outcome measure. FAS consists of all randomized subjects who received at least one dose of trial medication and who provide valid data to assess at least one of the primary efficacy endpoints.||participants|||Number
756600|NCT00596752|Primary|Occurrence of Major Amputations at 24 Weeks After the End of Study Drug Treatment|Assessment of amputations was collected per leg affected by a lesion with up to 2 lesions per subject. Amputations were regarded as major if they were performed at the ankle joint level or above. Amputations of toes or part of the foot leaving a stump thereon the subject can walk were regarded as minor. An affected leg is defined as a leg with at least 1 lesion on Study Day -6 to -2 and only amputations of affected legs are considered in the efficacy analysis of amputations. A subject is counted as major/minor amputated, if at least 1 affected leg was major/minor amputated.|At 24 weeks after the end of study drug treatment|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF) in case of missing values. FAS consists of all randomized subjects who received at least one dose of trial medication and who provide valid data to assess at least one of the primary efficacy endpoints.||participants|||Number
756601|NCT00596752|Primary|Complete Healing of Ischemic Necroses and Ulcerations at 12 Weeks After the End of Study Drug Treatment|The assessment of ulcer area was collected per lesion with up to 2 lesions per subject (both legs could be affected). In the analysis a subject is only considered completely healed at a time point, if all ischemic lesions are reported as completely healed at that time point.|At 12 weeks after the end of study drug treatment|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF) in case of missing values. FAS consists of all randomized subjects who received at least one dose of trial medication and who provide valid data to assess at least one of the primary efficacy endpoints.||participants|||Number
756602|NCT00596817|Secondary|Change From Double-blind Baseline in SDS Total Score at Week 24 of the Double-blind Period|The Sheehan Disability Scale (SDS) comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). The higher the score, the more severe.|Week 24 of the double-blind period (Counted From Double-blind Baseline)|FAS; OC||units on a scale||Standard Error|Mean
756603|NCT00596817|Secondary|Proportion of Remitters at Week 24 of the Double-blind Period (Remission Defined as a MADRS Total Score <=10)||Week 24 of the double-blind period|FAS; OC||percentage of patients|||Number
756604|NCT00596817|Secondary|Proportion of Responders at Week 24 of the Double-blind Period (Response Defined as a >=50% Reduction in MADRS Total Score From Open-label Baseline)||Week 24 of the double-blind period (Counted From Open-label Baseline)|FAS; OC||percentage of patients|||Number
756605|NCT00596817|Secondary|Change From Double-blind Baseline in CGI-S Score After 24 Weeks of Double-blind Treatment|The Clinical Global Impression - Severity of Illness (CGI-S) is a 7-point scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The investigator should use his/her total clinical experience with this patient population to judge how mentally ill the patient is at the time of rating.|Double-blind Baseline and Week 24 of the double-blind period|FAS; OC||units on a scale||Standard Error|Mean
756606|NCT00596817|Secondary|Change From Double-blind Baseline in HAM-A Total Score After 24 Weeks of Double-blind Treatment|The Hamilton Anxiety Rating Scale (HAM-A) consists of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behaviour at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic, and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total score from 0 to 56. The higher the score, the more severe.|Double-blind Baseline and Week 24 of the double-blind period|FAS; OC||units on a scale||Standard Error|Mean
756607|NCT00596817|Secondary|Change From Double-blind Baseline in HAM-D-17 Total Score After 24 Weeks of Double-blind Treatment|The Hamilton Depression Scale – 17 items (HAM-D-17) measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 52. The higher the score, the more severe.|Double-blind Baseline and Week 24 of the double-blind period|FAS; OC||units on a scale||Standard Error|Mean
756608|NCT00596817|Secondary|Change From Double-blind Baseline in MADRS Total Score After 24 Weeks of Double-blind Treatment||Double-blind Baseline and Week 24 of the double-blind period|FAS; observed cases (OC)||units on a scale||Standard Error|Mean
756609|NCT00596817|Secondary|Relapse During the Entire Double-blind Period Based on a MADRS Total Score >=22 or an Unsatisfactory Treatment Effect (Lack of Efficacy) as Judged by the Investigator||Within 64 weeks of the double-blind period|FAS||percentage of patients who relapsed|||Number
756610|NCT00596817|Primary|Relapse Within First 24 Weeks of the Double-blind Period Based on a MADRS Total Score >=22 or an Unsatisfactory Treatment Effect (Lack of Efficacy) as Judged by the Investigator|The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe.|Within first 24 weeks of the double-blind period|FAS||percentage of patients who relapsed|||Number
756611|NCT00596830|Secondary|Change From Baseline in Serum Insulin Growth Factor 1 (IGF1) Levels||Cycles 1 and 4 (predose) and at end of treatment|This study was terminated early due to futility. As such, these data were not analyzed.|||||
756612|NCT00596830|Secondary|Number of Participants With Total Anti-drug Antibodies (ADA)|ADAs are immunogenicity indicators to figitumumab. Participants reporting positive for ADAs are indicated by an endpoint titer of no less than 6.64.|Cycles 1, 2, and 4 (predose); 28 days and 150 days after the last figi dose|All participants who received figitumumab (CP-751,871).||participants|||Number
756613|NCT00596830|Secondary|Minimum Observed Plasma Trough Concentration (Cmin)for Figitumumab||Cycle 1, Day 1 (predose and 1 hour after end of infusion); Day 1 of Cycles 2, 4, 6 (predose); Cycle 5 Day 1 (predose, 1 hour after end of infusion); 28 days and 150 days after the last figi dose|This study was terminated early due to futility. As such, Cmin was not summarized.|||||
756614|NCT00596830|Secondary|Maximum Observed Plasma Concentration (Cmax) for Figitumumab||Cycle 1, Day 1 (predose and 1 hour after end of infusion); Day 1 of Cycles 2, 4, 6 (predose); Cycle 5 Day 1 (predose, 1 hour after end of infusion); 28 days and 150 days after the last figi dose|This study was terminated early due to futility. As such, Cmax was not summarized.|||||
756615|NCT00596830|Secondary|Euro Quality of Life (EQ-5D)- Health State Profile Utility Score|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range of -0.594 to 1; higher score indicates a better health state."|Day 1 of every cycle (3-weeks cycle), every 3 weeks during maintenance phase and at the End of Treatment Visit, assessed up to 37.4 months|Due to futility, the study was terminated early; therefore EQ-5D data were not analyzed.|||||
756616|NCT00596830|Secondary|European Organization for Research and Treatment of Cancer (EORTC), Quality of Life Questionnaire-Lung Cancer 13 (QLQ- LC13) Score|QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, other pain, and medicine for pain). Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.|Day 1 of every cycle (3-week cycle), every 3 weeks during maintenance phase and at the End of Treatment Visit, assessed up to 37.4 months|Due to futility, the study was terminated early; therefore these data were not analyzed.|||||
756617|NCT00596830|Secondary|European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30)|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms.|Day 1 of every cycle (3-week cycle), every 3 weeks during maintenance phase and at the End of Treatment Visit, assessed up to 37.4 months|Due to futility, the study was terminated early; therefore these data were not analyzed.|||||
756618|NCT00596830|Secondary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response(PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as complete disappearance of all target lesions and non-target disease. No new lesons. PR defined as ≥30% decrease under baseline of the sum of diameters of all target lesions. No unequivocal progression of non-target disease. No new lesions.|At baseline, every 6 weeks until radiological disease progression has been documented or the participant begins a subsequent anticancer therapy, up to 22.7 months|All randomized participants where participants were classified according to the randomized treatment regardless of what treatment, if any, was received.||percentage of participants||95% Confidence Interval|Number
756619|NCT00596830|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time from randomization to first progression or death due to any cause, whichever came first. Participants last known to be alive and progression-free, with baseline and >=1 on-study assessment, were censored at last disease assessment verifying lack of progression. Progression was determined by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 (20% increase in the sum of target lesions' longest diameter over nadir, unequivocal progression of non-target disease, or appearance of new lesions).|At baseline, every 6 weeks until radiological disease progression or the participant begins a subsequent anticancer therapy, up to 22.7 months.|All randomized participants where participants were classified according to the randomized treatment regardless of what treatment, if any, was received.||months||95% Confidence Interval|Median
756620|NCT00596830|Primary|Overall Survival (OS)|Overall survival was the duration from randomization to death. For participants who are alive, overall survival was censored at the last contact.|Baseline until death, assessed monthly after end of treatment, up to 30 months|All randomized participants where participants were classified according to the randomized treatment regardless of what treatment, if any, was received.||months||95% Confidence Interval|Median
756621|NCT00596934|Secondary|Insulin Resistance: Homeostatic Model Assessment (HOMA) at 12 Months|HOMA values in subjects that completed 12 months of metreleptin treatment.|1 year|7 subjects who completed 12 months of metreleptin treatment.||mU/L x mg/dL||Standard Deviation|Mean
756622|NCT00596934|Secondary|Fasting Triglycerides Value at 12 Months|Fasting triglyceride value in subjects that completed 12 months of metreleptin treatment.|1 year|7 subjects who completed 12 months of metreleptin treatment.||mg/dL||Standard Deviation|Mean
756623|NCT00596934|Secondary|Fasting Glucose Value at 12 Months|Fasting glucose value in subjects that completed 12 months of metreleptin treatment.|1 year|7 subjects who completed 12 months of metreleptin treatment.||mg/dL||Standard Deviation|Mean
756624|NCT00596934|Secondary|Liver Function Test: Aspartate Aminotransferase (AST) Values at 12 Months|AST value in subjects that completed 12 months of metreleptin treatment.|1 year|7 subjects who completed 12 months of metreleptin treatment.||IU/L||Standard Deviation|Mean
756625|NCT00596934|Secondary|Liver Function Test: Alanine Aminotransferase (ALT) Values at 12 Months|ALT value in subjects that completed 12 months of metreleptin treatment.|1 year|7 subjects who completed 12 months of metreleptin treatment.||IU/L||Standard Deviation|Mean
756626|NCT00596934|Secondary|Liver Fat Percentage by Magnetic Resonance Imaging (MRI - Dixon Method) at 12 Months|For determination of hepatic fat content by MRI and MR spectroscopy in patients, a series of out-phase and in-phase MRI at multiple flip angles are used. By combination of out-phase and in-phase MRI at multiple flip-angles and TE times, relaxation-time effects can be removed to yield quantitative intra-hepatic (and other organs’) fractional fat content throughout the liver in a few breath-hold intervals.|1 year|||liver fat percentage||Standard Deviation|Mean
756627|NCT00596934|Secondary|Body Weight at 12 Months|Body weight (kg) after one year of treatment on metreleptin for patients that completed 12 months of metreleptin treatment.|1 year|Subjects that completed 12 months of metreleptin treatment.||kg||Standard Deviation|Mean
756628|NCT00596934|Primary|Non-alcoholic Steatohepatitis Score as Determined by Liver Histopathology at 12 Months|Non-alcoholic steatohepatitis (NASH) score after approximately one year of treatment with metreleptin. Total NASH scores can range from 0 to 14. The higher the NASH score the more severe the liver disease.|1 year|Individuals who completed the year of metreleptin treatment and had follow-up liver biopsies after one year.||units on a scale||Standard Deviation|Mean
756629|NCT00596947|Secondary|The Number of Participants With Weight Gain|Height, weight will be used to calculate change in BMI for all participants.|12 months|unable to interpret results due to low number of patients enrolled.|||||
756630|NCT00596947|Secondary|The Number of Participants With Post Transplant Diabetes Mellitus|"Glucose tolerance test performed in non-diabetic participants only at pre transplant in living donor recipients and at baseline (within 1 mo after transplant) and 6 mo and 12 months. Blood test for hemoglobin A1C in non diabetic participants only: at baseline, 3, 6, and 12 months.
Insulin and C peptide levels at baseline, 3,6 and 12 months in all participants."|pre-transplant in living donor recipients, baseline (within one month post-transplant) and at 3, 6 and 12 months|unable to interpret results due to low number of patients enrolled.|||||
756631|NCT00596947|Secondary|The Number of Participants With Bone Disease|Bone densitometry by Computed tomography of peripheral skeleton and DEXA scans were performed at baseline (within one month after transplant) Urine and blood samples to measure markers of bone turnover: Alkaline phosphatase, pyridinoline, serum 1-25 vit D 3 levels (calcitriol) and 25 hydroxy vit D (calcidiol) levels and serum osteocalcin levels were drawn at baseline, 3, 6, 12 and 24 months.|baseline (within 1 month post-transplant), 3, 6, 12 and 24 months|unable to interpret results due to low number of patients enrolled.|||||
756632|NCT00596947|Secondary|The Number of Participants With Hyperlipidemia|Fasting lipid profiles were to be performed at 3,6 and 12 months post-transplant. Definitions based on ATP III guidelines.|12 months|Unable to interpret data due to low number of patients enrolled.|||||
756633|NCT00596947|Secondary|The Number of Participants With Hypertension|The number of participants who developed hypertension defined as blood pressure greater than 140/90 throughout the first 12 months of the study.|12 months|unable to interpret results due to low number of patients enrolled.|||||
756634|NCT00596947|Secondary|The Number of Participants With Malignancy|Participants would have been monitored throughout the study with any reports of malignancy being confirmed by principal investigator.|12 months|Unable to interpret data due to low number of patients enrolled.|||||
756635|NCT00596947|Secondary|The Number of Participants With Infections|Participants would have been monitored throughout the study for any infectious complications as confirmed by the principal investigator. Patients would have been monitored by urine cytology and blood polymerase chain reaction for BK virus at baseline, and months 3, 6 and 12 post-transplant.|12 months|Unable to interpret data due to low number of patients enrolled.|||||
756636|NCT00596947|Secondary|The Number of Participants With Leukopenia|All participants would have been assessed for the presence at any time during the trial of: leukopenia (defined by lab results as a white count less than 3,000 cells/uL).|12 months|unable to interpret results due to low number of patients enrolled.|||||
756637|NCT00596947|Secondary|The Number of Participants With the Need for Rabbit Antithymocyte Globulin to Treat Rejection Episodes.|The incidence and severity of rejection episodes per participant would have been identified by kidney transplant biopsy results read by a transplant pathologist. Treatment of rejection episodes in each participant would have been determined by the treating transplant physician.|12 months|unable to interpret results due to low number of patients enrolled.|||||
756638|NCT00596947|Primary|Participant Survival|The number of participants alive at 6 and 12 months post-transplant would have been posted as a measure of patient survival.|6 and 12 months|data not interpretable due to low patient enrollment|||||
756639|NCT00596947|Primary|The Number of Participants With Graft Survival|The number of participants who did not experience graft failure (defined as return to dialysis) at 6 and 12 months would have been reported.|6 and 12 months|data not interpretable due to low patient enrollment|||||
756640|NCT00596947|Secondary|Participant Renal Function as Measured by 24 Hour Urine Collection|Results would have been reported from patients undergoing 24 hour urine collections at 3 and 12 months post-transplant. This is a way to measure glomerular function rate (GFR) or renal function.|3 and 12 months post-transplant|Unable to interpret data due to low number of patients enrolled.|||||
756641|NCT00596947|Secondary|Participant Renal Function as Measured by MDRD Formula|The above methods focus on estimating or determining actual glomerular filtration rate (GFR) (or renal function) of the kidney transplant. The MDRD (Modification of Diet in Renal Disease) calculation includes age, sex and serum creatinine would have provided an estimate of GFR. This was to be performed at 3,6 and 12 months post-transplant.|3, 6 and 12 months|Unable to interpret data due to low number of patients enrolled.|||||
756642|NCT00596947|Secondary|The Length of Stay Associated With Hospital Readmissions|The time from admission to discharge for each readmission for patients readmitted in the first 12 months post-transplant.|12 months|Unable to interpret data due to low number of patients enrolled.|||||
756643|NCT00596947|Secondary|The Number of Participants With Hospital Readmissions|The number of readmissions during the study period for each participant would have been assessed, as well as the reason for readmissions.|12 months|Unable to interpret data due to low number of patients enrolled.|||||
756644|NCT00596947|Secondary|Length of Hospital Stay After Transplant|The length of the hospital stay would have assessed the number of days a participant was in the hospital after the kidney transplant was performed. This is calculated from date of admission to date of discharge.|12 months|unable to interpret results due to low number of patients enrolled.|||||
756645|NCT00596947|Secondary|The Number of Participants With Treatment Failures|This measure was defined as the percentage of participants that did not remain on initial therapy (ie were withdrawn from each arm of the trial)|12 months|Unable to interpret data due to low number of patients enrolled.|||||
756646|NCT00596947|Primary|The Number of Participants With Acute Rejection Episodes|Acute rejection episodes would have been measured by the number of participants who underwent a kidney transplant biopsy, and had the results of the biopsy reported as acute rejection by the transplant pathologist. Biopsies were only performed if clinically indicated. The cumulative number of participants with recorded rejection episodes by 6 and 12 months post-transplant would have been reported.|6 and 12 months post-transplant|data not interpretable due to low patient enrollment|||||
756647|NCT00596960|Secondary|Heavy Drinking Days (Greater or Equal to 4 Drinks)|This was measured as heavy drinking days per 30 day time frame. A standard drink was considered 14 oz. of alcohol or12 oz of regular beer, 5 oz of regular wine, or 1.5 oz of distilled spirits. A heavy drinking day was considered to be 4 or greater drinks during a day.|6-months|||heavy drinking days||Standard Deviation|Mean
756648|NCT00596960|Primary|Percent Days Abstinent From Alcohol at 6 Months|Alcohol use was measured for 30 days at baseline, 3-months and 6-months using the time-line follow back method. Percent days abstinent was measured by determining: days abstinent/30days X 100=%days abstinent.|6-months|||percentage of days abstinent||Standard Deviation|Mean
756649|NCT00596960|Primary|The Number of Alcohol Drinks Per Week (as Measured by the Time Line Follow Back Procedure) at the 6 Month Follow-up.|A standard drink was considered 14 oz. of alcohol or12 oz of regular beer, 5 oz of regular wine, or 1.5 oz of distilled spirits. The number of drinks per week was measured for 30 a day time frame at baseline, 3 months and 6-months.|6-months|||Standard Alcohol drinks||Standard Deviation|Mean
756650|NCT00597012|Secondary|SF-36 Physical Functional Status Scale - Difference From Baseline|Scores on the physical-activity scale of the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) range from 0 to 100, with higher scores indicating greater physical activity.|6 months|||Score||95% Confidence Interval|Mean
756651|NCT00597012|Secondary|KOOS Pain - Difference From Baseline|Scores on the pain scale of the Knee Injury and Osteoarthritis Outcome Scale (KOOS) range from 0 to 100, with higher scores indicating more pain. The secondary outcome was the difference between the study groups with respect to the change in the score on the pain scale of the Knee Injury and Osteoarthritis Outcome Scale (KOOS) from baseline to 6 months after randomization.|Baseline to 6 months|||Score||95% Confidence Interval|Mean
757021|NCT00605345|Secondary|Percentage of Participants Maintaining Hb Concentration in 10-12 g/dL Range Throughout the Efficacy Evaluation Period (EEP)||Weeks 16-28|Analysis performed with intent to treat (ITT) population, which includes all participants receiving at least one dose of the study drug.||percentage of participants|||Number
756652|NCT00597012|Primary|WOMAC Functional Status - Difference From Baseline|Scores on the physical-function subscale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) range from 0 to 100, with higher scores indicating more limitation of physical function. The primary outcome was the difference between the study groups with respect to the change in the score on the physical-function scale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) from baseline to 6 months after randomization.|Baseline and 6 months|||Score||95% Confidence Interval|Mean
756653|NCT00597038|Secondary|Number of Participants With 12 Month Overall Survival (OS)|Phase II - To determine Overall Survival of patients treated with the combination of dasatinib and DTIC at 12 months.|12 Months|All participants||participants|||Number
756654|NCT00597038|Secondary|Number of Participants With Progression Free Survival (PFS) at 6 Months|Phase II - PFS Rate in patients receiving dasatinib 70 mg orally (PO) twice a day (BID). Tumor assessments were made at baseline and at the end of every second cycle (i.e. every 6 weeks). Partial and complete responses were defined by the best treatment response achieved. Stable disease was defined as maintenance of the sum of lesions diameters between a 30% reduction and a 20% increase of overall tumour size over 12 weeks or longer.|6 Months|Patients receiving dasatinib at 70 mg PO BID||participants|||Number
756655|NCT00597038|Primary|Phase II - Number of Participants With Overall Response (OR)|Phase II - To determine the overall response rate (ORR) of the combination of dasatinib and DTIC by the Response Evaluation Criteria in Solid Tumors (RECIST v1.0). Tumor assessments were made at baseline and at the end of every second cycle (i.e. every 6 weeks). Partial and complete responses were defined by the best treatment response achieved.|1 Year 6 Months|Patients receiving dasatinib at 70 mg PO BID||participants|||Number
756656|NCT00597038|Primary|Recommended Phase II Dose|To determine the maximum tolerated dose of dasatinib twice a day when given with dacarbazine. Adverse events were graded using Common Terminology Criteria for Adverse Events version 3.0. Dose-limiting toxicities are defined as any grade 4 haematological toxicity (except asymptomatic grade 4 neutropenia for =/< 7 days); prolonged grade 3 or 4 thrombocytopenia (47 days) or thrombocytopenia associated with bleeding, requiring platelet transfusion; any grade 3 or 4 nonhaematological toxicity despite optimal supportive care; any toxicity considered unacceptable by the study principal investigator.|1 Year 3 Months|All participants in Arm A||mg|||Number
756657|NCT00597116|Secondary|Overall Survival (OS)||Assessed from baseline to 12 months.|Only patients in the evaluable for efficacy population were included. It was defined as all treated patients with no major deviations from the eligibility criteria affecting the evaluation of efficacy, who completed at least 2 cycles (unless progressive disease occurred at cycle 1) and who had at least one post-treatment tumour assessment.||Months||95% Confidence Interval|Median
756658|NCT00597116|Secondary|Progression-free Survival (PFS)|Time from randomization to date of documented response of progressive disease (PD) as assessed according to the modified RECIST criteria for assessment of response in malignant pleural mesothelioma. PD is defined as an increase of at least 20% in the total tumour measurement over the nadir measurement, or the appearance of one or more new lesions.|Assessed from baseline to 12 months.|Only patients in the evaluable for efficacy population were included. It was defined as all treated patients with no major deviations from the eligibility criteria affecting the evaluation of efficacy, who completed at least 2 cycles (unless progressive disease occurred at cycle 1) and who had at least one post-treatment tumour assessment.||Months||95% Confidence Interval|Median
756659|NCT00597116|Secondary|Number of Participants With Objective Response.|Objective response is defined as having a complete response (CR) or a partial response (PR) according to the modified RECIST criteria for assessment of response in malignant pleural mesothelioma. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere and PR is defined as at least a 30% reduction in the total tumour measurement. A confirmed response requires a repeat observation on two occasions 4 weeks apart.|Assessed at 2 months.|Only patients in the evaluable for efficacy population were included. It was defined as all treated patients with no major deviations from the eligibility criteria affecting the evaluation of efficacy, who completed at least 2 cycles (unless progressive disease occurred at cycle 1) and who had at least one post-treatment tumour assessment.||Participants|||Number
756660|NCT00597116|Primary|Number of Participants With Disease Control.|Disease control is defined as having a complete response (CR), a partial response (PR) or stable disease (SD) according to the modified RECIST criteria for assessment of response in malignant pleural mesothelioma. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere and PR is defined as at least a 30% reduction in the total tumour measurement. A confirmed response requires a repeat observation on two occasions 4 weeks apart. PD is defined as an increase of at least 20% in the total tumour measurement over the nadir measurement, or the appearance of one or more new lesions. Patients with SD are those who fulfill the criteria for neither PR nor PD.|Assessed at 2 months.|Only patients in the evaluable for efficacy population were included.It was defined as all treated patients with no major deviations from the eligibility criteria affecting the evaluation of efficacy, who completed at least 2 cycles(unless progressive disease occurred at cycle 1)and who had at least one post-treatment tumour assessment.||Participants|||Number
756661|NCT00597207|Secondary|Sustained ROSC, Survival to 24 Hours, Hospital Discharge With a MRS ≤ 3, Process Outcomes: Number of Shocks, Duration of Pulselessness From 911 Call to ROSC, Hands-on Interval or Other Measures of CPR Quality||during the case||||||
756662|NCT00597207|Secondary|Neurology||30 days||||||
756663|NCT00597207|Primary|Hospital Discharge|Whether a subject was discharged alive from the hospital or alternatively died prior to discharge.|From time of first contact until hospital discharge, up to 90 days.|||participants|||Number
756664|NCT00597272|Primary|Toxicity|Toxicity will be graded in accordance with Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|2 years|||participants|||Number
756665|NCT00597376|Secondary|Six Month Levels of Inflammation and Oxidative Stress Markers(as a Percent of Baseline Levels) After Daily Treatment With Cerefolin NAC and a Multivitamin or a Multivitamin Only|Outcome measures were 6-month levels of highly sensitive c-reactive protein (hs-CRP), tumor necrosis factor alpha (TNF-alpha), interleukin-6 (IL-6), malondialdehyde, and potential anti-oxidant (PAO)in blood samples as a percent of baseline value.|6 months|All participants in Intent-to-Treat were included with last observation carried forward.||percent of baseline level||95% Confidence Interval|Mean
765980|NCT00683787|Primary|Overall Response Rate||1 year|Due to the study's early termination and inadequate number of patients no statistical inference of the primary and secondary aims were carried forth.|||||
756666|NCT00597376|Secondary|Tolerability of Cerefolin NAC and a Multivitamin Versus a Multivitamin Only|Mean study product compliance was measured as the actual number of study product tablets taken as a percent of the maximum study product tablets that could have been taken during the intervention period.|6 months|All participants in Intent-to-Treat cohort were included.||percent of study drug taken||Standard Error|Mean
756667|NCT00597376|Primary|Six Month Blood Levels of Homocysteine, Glutathione, and the Ratio of Aβ42 to Aβ40 (as a Percent of Baseline Levels) After Daily Intake of Cerefolin NAC Plus a Multivitamin Versus a Multivitamin Only|Primary outcome markers were plasma homocysteine (tHcy), glutathione, and the ratio of amyloid proteins, Aβ42 and Aβ40. Plasma tHcy and glutathione were assayed using a high performance liquid chromatography (HPLC) with fluorescence detection method. Enzyme-linked immunosorbent assays (ELISA) were used for Aβ42 (Wako Chemicals USA, Inc., Richmond, VA) and Aβ40 (Invitrogen Corporation, Canarillo, CA) detection. Primary analyses utilized Last Observation Carried Forward (LOCF) to assess the primary biomarker level at 6 months versus baseline. Six month levels in biomarker outcomes were compared using t-tests of the logarithmically transformed values and the antilogarithm was applied to the SDs obtain 95% confidence intervals (95% CIs). A significant difference between treatments was needed for at least one of the primary outcome variables (tHcy, glutathione, or the Aβ42 to Aβ40 ratio) to declare the study positive.|6 months|The Intent-to-Treat (ITT) cohort included randomized subjects taking at least one study treatment dose. Primary analyses utilized Last Observation Carried Forward (LOCF) to assess 6 month levels in the primary biomarkers. 2-sided, t-test p-value for group differences was only significant (<0.05) for 6-month homocysteine level.||percent of baseline level||95% Confidence Interval|Mean
756668|NCT00597402|Secondary|Number of Patients Experiencing a Grade ≥ 4 Hematologic or Grade ≥ 3 Non-hematologic Toxicity|Number of times a grade ≥ 4 hematologic or grade ≥ 3 non-hematologic toxicity was experienced|55 months|||participants|||Number
756669|NCT00597402|Secondary|Number of Patients Experiencing a Central Nervous System (CNS) Hemorrhage or a Systemic Hemorrhage|Number of times a CNS hemorrhage or systemic hemorrhage was experienced|55 months|||participants|||Number
756670|NCT00597402|Secondary|12-month Progression-free Survival (PFS)|Percentage of participants surviving twelve months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to the Macdonald criteria, or to death due to any cause.|12 months|||percentage of participants||95% Confidence Interval|Number
756671|NCT00597402|Primary|16-month Overall Survival (OS)|Percentage of participants surviving sixteen months from the start of study treatment. OS was defined as the time from the date of study treatment initiation to the date of death due to any cause.|16 months|Intent to treat||percentage of participants||95% Confidence Interval|Number
756672|NCT00597428|Secondary|Treatment Effectiveness|Treatment effectiveness scale: 0 = not at all effective, 1 = a little bit effective, 2 = moderately effective, 3 = quite a bit effective, 4 = extremely effective|Weeks 1-12|Treatment effectiveness scores were collected at the end of each treatment week during the study; the number of participants analyzed reflects those subjects who provided at least one end-of-week assessment of treatment effectiveness. For the analysis, treatment effectiveness scores were averaged across the treatment period (Weeks 1-12).||units on a scale||Standard Deviation|Mean
756673|NCT00597428|Secondary|Mean Changes From Baseline in Straining, Stool Consistency, Constipation Severity, Abdominal Bloating, Abdominal Discomfort, and Bowel Habit Regularity|Ratings over 12-week treatment period were averaged and difference from baseline score calculated Straining scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe Stool consistency scale: 0 = very loose, 1 = loose, 2 = normal, 3 = hard, 4 = very hard (little balls) Constipation severity scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe Abdominal bloating scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe Abdominal discomfort scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe Bowel habit regularity scale: 7-point scale, where 1 = very regular and 7 = very irregular|Weeks 1-12|||units on a scale||Standard Deviation|Mean
756674|NCT00597428|Secondary|Responder Rate|Number of participants, who remained on treatment for at least 8 weeks, and reported response (>=3 SBMs) for at least 50% of weeks on study.|Up to 12 weeks|||participants|||Number
756675|NCT00597428|Secondary|First Post-dose SBM|The number of participants that experienced first post-dose SBM 24 and 48 hour of dose initiation.|24 and 48 hours post-dose|||participants|||Number
756676|NCT00597428|Secondary|Change From Baseline in Mean Weekly SBM Frequency|For overall assessment of change, average weekly rating was calculated from data collected from Week 1 through Week 12.|Baseline, Week 12, and Weeks 1-12|||Spontaneous Bowel Movements/Week||Standard Deviation|Mean
756677|NCT00597428|Primary|Change From Baseline in Mean Weekly Spontaneous Bowel Movement (SBM) Frequency in Subjects Without Dose Reduction Prior to Week 8||Baseline and Week 8|||Spontaneous Bowel Movements/Week||Standard Deviation|Mean
756678|NCT00597493|Secondary|Pharmacokinetics: AUC-24|Blood sampling for sorafenib pharmacokinetics was performed on days 1 and 28 of cycle 1 and was obtained before and at 0.5, 1, 2, 4, 6, 8, and 24 h after the morning dose. AUC-24 refers to area under the plasma concentration-time curve from 0 to 24 hours. The pharmacokinetics of those patients taking enzyme-inducing antiepileptic drugs (EIAEDs) and those who were not were analyzed separately.|13 months|9 participants who were on EIAEDs had 24 hour sorafenib concentration versus time profiles from both day 1 and day 28 of cycle 1. 14 participants who were not on EIAEDs underwent similar assessment for day 1 but only 10 of these participants had samples available for day 28 measurements.||ug*H/L||Geometric Coefficient of Variation|Geometric Mean
756679|NCT00597493|Secondary|Pharmacokinetics: T-max|Blood sampling for sorafenib pharmacokinetics was performed on days 1 and 28 of cycle 1 and was obtained before and at 0.5, 1, 2, 4, 6, 8, and 24 h after the morning dose. T-max refers to time to maximum concentration. The pharmacokinetics of those patients taking enzyme-inducing antiepileptic drugs (EIAED) and those who were not were analyzed separately.|13 months|9 participants who were on EIAEDs had 24 hour sorafenib concentration versus time profiles from both day 1 and day 28 of cycle 1. 14 participants who were not on EIAEDs underwent similar assessment for day 1 but only 10 of these participants had samples available for day 28 measurements.||hours||Full Range|Median
757146|NCT00589121|Other Pre-specified|Correlation of Late Radiation Morbidity at 2 Years With the 3 Quality of Life Assessments [Functional Assessment of Cancer Therapy-General (FACTG), Toronto Extremity Salvage Score (TESS), and Sexual Adjustment Questionnaire (SAQ)]||2 years after start of treatment (+/- 3 months)||||||
756680|NCT00597493|Secondary|Pharmacokinetics: C-max|Blood sampling for sorafenib pharmacokinetics was performed on days 1 and 28 of cycle 1 and was obtained before and at 0.5, 1, 2, 4, 6, 8, and 24 h after the morning dose. C-max refers to maximum plasma concentration. The pharmacokinetics of those patients taking enzyme-inducing antiepileptic drugs (EIAED) and those who were not were analyzed separately.|13 months|9 participants who were on EIAEDs had 24 hour sorafenib concentration versus time profiles from both day 1 and day 28 of cycle 1. 14 participants who were not on EIAEDs underwent similar assessment for day 1 but only 10 of these participants had samples available for day 28 measurements.||ug/L||Geometric Coefficient of Variation|Geometric Mean
756681|NCT00597493|Secondary|Safety and Toxicity of Combination|Number of participants experiencing a toxicity of at least grade 3 that was deemed possibly, probably, or definitely related to the treatment.|16 months|||participants|||Number
756682|NCT00597493|Primary|6 Month Progression Free Survival (PFS)|Percentage of participants surviving six months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to the Macdonald criteria, or to death due to any cause.|6 months|||percentage of patients||95% Confidence Interval|Number
756683|NCT00597506|Primary|Progression Free Survival (PFS)|8 week PFS|interval between start of treatment and 8-week|50 patients were enrolled and received bevacizumab at 10mg/kg every 2 weeks and everolimus at 10mg orally daily. However, only 49 patients were evaluable for progression. One patient who received less than 1 cycle of the regimen and died from a non-treatment-related illness was not included in the analysis.||proportion of participants||90% Confidence Interval|Number
756684|NCT00597506|Primary|Overall Response|Overall response is composed of complete responses and partial responses. Complete response (CR): disappearance of all target lesions; Partial response: at least a 30 percent decrease in the sum of the longest diameter of the target lesions taking as reference the baseline sum longest diameter. Response is assessed at each subject's restaging, approximately ever 2 months.|Measured 1 month after the last treated subject came off treatment|50 patients were enrolled and received bevacizumab at 10mg/kg every 2 weeks and everolimus at 10mg orally daily. However, only 49 patients were evaluable for progression. One patient who received less than 1 cycle of the regimen and died from a non-treatment-related illness was not included in the analysis.||percentage of participants|||Number
756685|NCT00603408|Secondary|Provide Samples for the Development of the FNA Assay||At time of IVAD placement and at time of surgery|Collecting tissue from the optional mastectomy was optional and was not collected on any of the patients.|||||
756686|NCT00603408|Secondary|Develop Animal Models of Triple Negative Breast Cancers||5 years|Collecting tissue from the optional mastectomy was optional and was not collected on any of the patients.|||||
756687|NCT00603408|Secondary|Effect of Neoadjuvant Chemoradiation Therapy in Disseminated Cancer Cells in the Bone Marrow and Correlation to Tumor Response||5 years|Collecting bone marrow samples were optional and at the time of surgery only 2 patients participated and at the time of port removal submission none of the patients participated.|||||
756688|NCT00603408|Secondary|Number of Participants With Medical Toxicities|The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for all toxicity reporting. All detailed information regarding serious and other adverse events are listed in the Adverse Event module of these results.|30 days post surgery (week 17-18)|||participants|||Number
756689|NCT00603408|Secondary|Number of Participants With Surgical Complications||30 days post surgery (week 17-18)|||participants|||Number
756690|NCT00603408|Secondary|Overall Survival Rate (OS)|OS = Time from registration until death from any cause|Until study was terminated (23.5 months)|||percentage of participants|||Number
756691|NCT00603408|Secondary|Time to Disease Progression|Time to disease progression: time from registration until objective tumor progression; does not include deaths|Until study was terminated (23.5 months)|At the time of study termination, no participants had experienced disease progression.|||||
756692|NCT00603408|Primary|Overall Response|"Complete response: disappearance of all target lesions, non-target lesions, and normalization of tumor marker level
Partial response: at least a 30% decrease in the sum of the longest diameter (LD) of the target lesions taking as reference the baseline sum LD
Stable disease: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD since the treatment started,
Progressive disease: at least a 20% increase in the sum of the LD of the target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, appearance of one more new lesions, or unequivocal progression of existing non-target lesions."|At the time of surgery (week 13)|||participants|||Number
756693|NCT00603447|Primary|Number of Participants With Dose-limiting Toxicities|"Dose-limiting toxicity was defined as any of the following events assessed as related to carfilzomib, lenalidomide, or dexamethasone: Nonhematologic
≥ Grade 2 neuropathy with pain
≥ Grade 3 nonhematologic toxicity (excluding nausea, vomiting, diarrhea, hyperglycemia due to dexamethasone, and rash due to lenalidomide)
≥ Grade 3 nausea, vomiting, or diarrhea uncontrolled by maximal supportive therapy
≥ Grade 4 fatigue persisting > 7 days
Treatment delay for toxicity > 21 days
Hematologic
Grade 4 neutropenia (absolute neutrophil count [ANC] < 500/mm³) > 7 days
Febrile neutropenia (ANC < 1,000/mm³ with fever ≥ 38.3ºC)
Grade 4 thrombocytopenia (platelets < 25,000/mm³) for > 7 days despite holding treatment, or Grade 3 or 4 thrombocytopenia associated with bleeding
Treatment delay for toxicity > 21 days.
The maximum-tolerated dose was defined as the dose level below which a drug-related DLT was observed in ≥ 33% of participants in a cohort."|Cycle 1, 28 days|Safety population for the dose escalation portion of the study||participants|||Number
756702|NCT00603512|Secondary|Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])|DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) less than or equal to (=<) 3.2 implied low disease activity, greater than (>) 3.2 to 5.1 implied moderate to high disease activity and less than (<) 2.6=remission.|Baseline, Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
756694|NCT00603447|Primary|Number of Participants With Adverse Events (AEs)|"Treatment-related are those AEs with possible or probable relationship to carfilzomib, lenalidomide or dexamethasone as assessed by the Investigator. The severity of each adverse event was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3.0, per the following: Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death.
Serious adverse events were defined as AEs meeting one of the following: death, life-threatening, required or prolonged in-patient hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect in the offspring of an exposed participant, important medical events that may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed above, or pregnancy or suspected pregnancy."|From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months.|Safety population consisting of all treated participants||participants|||Number
756695|NCT00603473|Secondary|Percent Change in Seizure Frequency (PCH)|PCH calculated by the following equation was assessed as secondary endpoint: PCH = 100 (T−B) / B where T is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 12-week treatment period, and B is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 6-week baseline period.|12 weeks|Modified intent-to-treat (MITT) population: Subjects who have received the study medication for at least 28 days and in whom the number of epileptic seizures used for efficacy assessment has been counted for at least 28 days in both the baseline and treatment periods.||Percent Change||Full Range|Median
756696|NCT00603473|Secondary|Responder Rate|Responder Rate was defined as the percentage of subjects with a 50% or greater reduction in the seizure frequency per 28 days for the 12-week treatment period in comparison with the frequency per 28 days for the 6-week baseline period.|12 weeks|Modified intent-to-treat (MITT) population: Subjects who have received the study medication for at least 28 days and in whom the number of epileptic seizures used for efficacy assessment has been counted for at least 28 days in both the baseline and treatment periods.||Percentage of Subjects||95% Confidence Interval|Mean
756697|NCT00603473|Primary|Response Ratio of Gabapentin in Japanese Pediatric Patients With Partial Seizures|The Response Ratio calculated by the following equation was assessed as the primary endpoint: R Ratio = (T−B) / (T+B) where T is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 12-week treatment period, and B is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 6-week baseline period.|12 weeks|Modified intent-to-treat (MITT) population: Subjects who have received the study medication for at least 28 days and in whom the number of epileptic seizures used for efficacy assessment has been counted for at least 28 days in both the baseline and treatment periods.||ratio||95% Confidence Interval|Mean
756698|NCT00603512|Secondary|Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale|FACIT-F is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.|Baseline, Week 2, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
756699|NCT00603512|Secondary|Medical Outcome Study- Sleep Scale (MOS-SS)|Participant-rated 12 item questionnaire assess constructs of sleep over past week.7 subscales:sleep disturbance(SD),snoring(Sno),awakened short of breath(ASOB),sleep adequacy(Ade),somnolence(Som)(range:0-100);sleep quantity(Qua)(range:0-24),optimal(Opt) sleep(yes:1,no:0),9 item index measures of sleep disturbance provide composite scores:sleep problem summary(SPS),overall SP(OSP).Except Ade,Opt,Qua,higher scores=more impairment.Scores transformed(actual raw score(RS) minus lowest possible score divided by possible RS range*100);total score range:0-100;higher score=more intensity of attribute.|Baseline, Week 2, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
756700|NCT00603512|Secondary|Euro Quality of Life (EQ-5D)- Health State Profile Utility Score|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, selfcare, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Week 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
756701|NCT00603512|Secondary|36-Item Short-Form Health Survey (SF-36)|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline, Week 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
756703|NCT00603512|Secondary|Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])|DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) less than or equal to (=<) 3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Baseline, Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
756704|NCT00603512|Secondary|Area Under the Numeric Index of American College of Rheumatology Response (ACR-n) Curve|ACR-n = calculated for each participant by taking lowest percentage improvement in (1) swollen joint count or (2) tender joint count or (3) the median of remaining 5 components of ACR response (participant's assessment of disease activity; participant's global assessment of pain; physician's assessment of disease activity; participant's assessment of physical function; an acute phase reactant value - CRP). Negative numbers indicate worsening. The AUC for ACR-n is measure of the area under the curve of the mean change from baseline in ACR-n. The trapezoidal rule was used to compute AUC.|Baseline up to Week 12|FAS included all randomized participants who received at least 1 dose of study medication. Missing values were imputed using LOCF method.||units on a scale*weeks||Standard Deviation|Mean
756705|NCT00603512|Secondary|Numeric Index of American College of Rheumatology Response (ACR-n)|ACR-n = calculated for each participant by taking the lowest percentage improvement in (1) SJC or (2) TJC or (3) the median of the remaining 5 components of the ACR response (participant's assessment of disease activity; participant's global assessment of pain; physician's assessment of disease activity; participant's assessment of physical function; an acute phase reactant value - CRP). Negative numbers indicate worsening.|Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. Missing values were imputed using LOCF method.||units on a scale||Standard Deviation|Mean
756706|NCT00603512|Secondary|Change From Baseline in C-Reactive Protein (CRP) at Week 1, 2, 4, 8 and 12/EOT|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is 0 milligram per liter (mg/L) to 10 mg/L. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.||mg/L||Standard Deviation|Mean
756707|NCT00603512|Secondary|C-Reactive Protein (CRP)|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is 0 milligram per liter (mg/L) to 10 mg/L. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.||mg/L||Standard Deviation|Mean
756708|NCT00603512|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 1, 2, 4, 8 and 12/EOT|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
756709|NCT00603512|Secondary|Health Assessment Questionnaire-Disability Index (HAQ-DI)|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
756710|NCT00603512|Secondary|Change From Baseline in Physician Global Assessment of Arthritis (PGA) at Week 1, 2, 4, 8 and 12/EOT|Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 = very good and 100 = very bad.|Baseline, Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.||mm||Standard Deviation|Mean
756711|NCT00603512|Secondary|Physician Global Assessment (PGA) of Arthritis|Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 = very good and 100 = very bad.|Baseline, Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.||mm||Standard Deviation|Mean
756712|NCT00603512|Secondary|Change From Baseline in Patient Global Assessment of Arthritis (PtGA) at Week 1, 2, 4, 8 and 12/EOT|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS, where 0 = very well and 100 = very poorly."|Baseline, Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.||mm||Standard Deviation|Mean
756713|NCT00603512|Secondary|Patient Global Assessment (PtGA) of Arthritis|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS, where 0 = very well and 100 = very poorly."|Baseline, Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.||mm||Standard Deviation|Mean
756714|NCT00603512|Secondary|Change From Baseline in Patient Assessment of Arthritis Pain at Week 1, 2, 4, 8 and 12/EOT|Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 = no pain and 100 = most severe pain.|Baseline, Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.||mm||Standard Deviation|Mean
757298|NCT00607672|Secondary|New Onset Atrial Fibrillation|New onset atrial fibrillation based on electrocardiogram (ECG) rhythm strips with a duration longer than 10 seconds|From arrival in intensive care unit until discharge from hospital|||percentage of patients|||Number
756715|NCT00603512|Secondary|Patient Assessment of Arthritis Pain|Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS), where 0 = no pain and 100 = most severe pain.|Baseline, Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.||mm||Standard Deviation|Mean
756716|NCT00603512|Secondary|Change From Baseline in Swollen Joint Count (SJC) at Week 1, 2, 4, 8 and 12/EOT|Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1. A negative value in change from baseline indicates an improvement.|Baseline, Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.||swollen joints||Standard Deviation|Mean
756717|NCT00603512|Secondary|Swollen Joint Count (SJC)|Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1.|Baseline, Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.||swollen joints||Standard Deviation|Mean
756718|NCT00603512|Secondary|Change From Baseline in Tender Joint Count (TJC) at Week 1, 2, 4, 8 and 12/EOT|Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1. A negative value in change from baseline indicates an improvement.|Baseline, Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.||tender joints||Standard Deviation|Mean
756719|NCT00603512|Secondary|Tender Joint Count (TJC)|Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.|Baseline, Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.||tender joints||Standard Deviation|Mean
756720|NCT00603512|Secondary|Percentage of Participants Achieving American College of Rheumatology 90% (ACR90) Response|ACR90 response: >= 90% improvement in tender or swollen joint counts and 90% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. Missing values were imputed using LOCF method.||Percentage of Participants|||Number
756721|NCT00603512|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response|ACR70 response: >= 70% improvement in tender or swollen joint counts and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. Missing values were imputed using LOCF method.||Percentage of Participants|||Number
756722|NCT00603512|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response|ACR50 response: >= 50% improvement in tender or swollen joint counts and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 1, 2, 4, 8, 12/End of Treatment (EOT)|FAS included all randomized participants who received at least 1 dose of study medication. Missing values were imputed using LOCF method.||Percentage of Participants|||Number
756723|NCT00603512|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response|ACR20 response: >= 20% improvement in TJC; >= 20% improvement in SJC; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 1, 2, 4, 8|FAS included all randomized participants who received at least 1 dose of study medication. Missing values were imputed using LOCF method.||Percentage of Participants|||Number
756724|NCT00603512|Primary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12|ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count (TJC); >= 20% improvement in swollen joint count (SJC); and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Week 12|Full analysis set (FAS) included all randomized participants who received at least 1 dose of study medication. Missing values were imputed using Last observation carried forward (LOCF) method.||Percentage of Participants|||Number
756725|NCT00603525|Secondary|Number of Participants With the Indicated Hematology Values of Potential Clinical Concern During the Follow-up Period|Only those parameters for which at least one value of clinical concern (CC) was reported are summarized. Pre-defined limits of potential clinical concern (CC Low [relative to lower limit of normal], CC High [relative to upper limit of normal]) are: Eosinophils: NA, 2; Total neutrophils: 0.8, 1.6; Platelet count: 0.65, 1.5.|From the last scheduled visit in the DB or OL Period until B-cells and circulating IgG had returned to normal or baseline levels (maximum of 2 years)|AT Population. Only participants who withdrew from the DB Period and had evidence of contact with the site after the end of the DB Period and all participants who withdrew or completed the OL Period and had evidence of contact with the site after their end of OL date were analyzed.||Participants|||Number
757299|NCT00607672|Secondary|Vasopressor Drug Use||From the end of cardiopulmonary bypass until arrival in intensive care unit|||percentage of patients|||Number
756726|NCT00603525|Secondary|Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern During the Follow-up Period|Only those parameters for which at least one value of clinical concern (CC) was reported are summarized. Pre-defined limits of potential clinical concern (CC Low [relative to the lower limit of normal], CC High [relative to the upper limit of normal]) are: ALT: NA, 2; ALP: NA, 1.5; TBIL: NA, 1.5; CO2/BCO: 0.85, 1.2; CK: NA, 2; GGT: NA, 2; Urea/BUN: NA, 1.5.|From the last scheduled visit in the DB or OL Period until B-cells and circulating IgG had returned to normal or baseline levels (maximum of 2 years)|AT Population. Only participants who withdrew from the DB Period and had evidence of contact with the site after the end of the DB Period and all participants who withdrew or completed the OL Period and had evidence of contact with the site after their end of OL date were analyzed.||Participants|||Number
756727|NCT00603525|Secondary|Number of Participants With a Positive JC Virus Test Result During the Follow-up Period|Blood samples were collected for analysis of plasma/white blood cell JC Virus (JCV) using the polymerase chain reaction (PCR) assay. Positive JC Virus test result indicated presence of JC Virus.|From the last scheduled visit in the DB or OL Period until B-cells and circulating IgG had returned to normal or baseline levels (or maximum of 2 years from LSLV)|AT Population. Only those participants contributing values at the indicated time point were analyzed.||Participants|||Number
756728|NCT00603525|Secondary|Time to First CD19+ B-cell Repopulation Relative to the First Dose and Last Dose of Ofatumumab|Time to first CD19+ B-cell repopulation (return to normal or baseline level) relative to the first dose was assessed only for those participants whose B-cells repopulated after receiving ofatumumab. Time to first CD19+ B-cell repopulation relative to the last dose of ofatumumab was assessed only for those participants whose B-cells repopulated during their last ofatumumab treatment course or follow-up.|From the first dose of ofatumumab until the last Follow-up Period visit (up to Week 248)|AT Population. Only those participants contributing values at the indicated time point were analyzed.||Months||Full Range|Median
756729|NCT00603525|Secondary|Number of Participants With Immunoglobulin Values Outside the Reference Range During the Follow-up Period|The reference ranges for immunoglobulins (LLN, ULN) are defined as: IgA (grams/Liter): 0.81, 4.63; IgG (grams/Liter): 6.94, 16.18; IgM (grams/Liter): 0.48, 2.71.|From the last scheduled visit in the DB or OL Period until B-cells and circulating IgG had returned to normal or baseline levels (or maximum of 2 years from LSLV)|AT Population. Only those participants contributing values at the indicated time point were analyzed.||Participants|||Number
756730|NCT00603525|Secondary|Number of Participants With Any Serious Adverse Event During the Follow-up Period|A serious adverse event is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; or is a congenital anomaly/birth defect. Medical or scientific judgment should have been exercised in other situations. Refer to the general SAE module for a list of SAEs.|From the last scheduled visit in the DB or OL Period until B-cells and circulating IgG had returned to normal or baseline levels (or maximum of 2 years from Last Subject Last Visit [LSLV])|Safety Follow-up Population: all participants who withdrew from the Double-blind Period and had evidence of contact with the site after the end of the Double-blind Period and all participants who withdrew or completed the Open-label Period and had evidence of contact with the site after their end of Open-label date.||Participants|||Number
756731|NCT00603525|Secondary|Number of Participants With Positive John Cunningham (JC) Virus Test Results at Baseline or Any Visit Post-baseline During the DB and OL Periods|Blood samples were collected for analysis of plasma/white blood cell JC Virus (JCV) using the polymerase chain reaction (PCR) assay. A positive JC Virus test result indicates the presence of JC Virus.|From basline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.||Participants|||Number
756732|NCT00603525|Secondary|Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course|The baseline value for a treatment course is defined as the latest value on or before the date of infusion A of the treatment course. The post-baseline visit is defined as any visit after the date of infusion A during the specified treatment course. Reference ranges (LLN, ULN) used for immunoglobulins are: immunoglobulin A (IgA) (grams/Liter): 0.81, 4.63; immunoglobulin G (IgG) (grams/Liter): 6.94, 16.18; immunoglobulin M (IgM) (grams/Liter): 0.48, 2.71.|From baseline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.||Participants|||Number
756733|NCT00603525|Secondary|Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course|The baseline value for a treatment course is defined as the value before infusion A of each treatment course. The post-baseline visit is defined as any assessment during or after the start of infusion A during the specified treatment course. Pre-defined limits of potential clinical concern for vital signs (Low, High) are: Diastolic blood pressure (DBP) (millimeters of mercury [mmHg]): 40, 110; Systolic blood pressure (SBP) (mmHg): 90, 170; Heart rate (beats per minute): 35, 120. LLN=lower limit of normal; ULN=upper limit of normal.|From baseline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.||Participants|||Number
756734|NCT00603525|Secondary|Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course|Only those parameters for which at least one value of clinical concern (CC) was reported are summarized. The baseline (BL) value for a treatment course is defined as the latest value on or before the date of infusion A of the treatment course. The post-baseline (PBL) visit is defined as any visit after the date of infusion A during the specified treatment course. Pre-defined limits of potential clinical concern (CC Low [relative to lower limit of normal], CC High [relative to upper limit of normal]) are: Eosinophils: NA, 2; Hematocrit (HCT): 0.75, 1.2; Hemoglobin (Hb): 0.75, 1.2; Monocytes: 0.2, 5 2; Neutrophils total (TNUE): 0.8, 1.6; Platelet count (PC): 0.65, 1.5; Red blood cell count (RBC): 0.7, 5 2; White blood cell count (WBC): 0.7, 1.6.|From baseline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.||Participants|||Number
756934|NCT00604825|Primary|Change From Baseline in Thrombotic Marker- Fibrinogen at Week 12|Thrombotic marker included fibrinogen. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 12|Safety Population. Only those participants available at the specified time points were analyzed.||Gram per LIter||Standard Deviation|Mean
756735|NCT00603525|Secondary|Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course|Only those parameters for which at least one value of clinical concern (CC) was reported are summarized. The baseline (BL) value for a treatment course is defined as the latest value on or before the date of infusion A of the treatment course. The post-baseline (PBL) visit is defined as any visit after the date of infusion A during the specified treatment course. Pre-defined limits of potential clinical concern (CC Low [relative to the lower limit of normal], CC High [relative to the upper limit of normal]) are: Albumin: 0.9, 1.5; Alanine amino transferase (ALT): NA, 2; Alkaline phosphatase (ALP): NA, 1.5; Aspartate amino transferase (AST): NA, 2; Bilirubin total (TBIL): NA, 1.5; Calcium: 0.85, 1.08; CO2 content/bicarbonate (BCO): 0.85, 1.2; Creatine kinase (CK): NA, 2; Creatinine: NA, 1.2; Gamma glutamyl transferase (GGT): NA, 2; Potassium: 0.9, 1.1; Urea/blood urea nitrogen (BUN): NA, 1.5; Uric acid: NA, 1.5.|From baseline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.||Participants|||Number
756736|NCT00603525|Secondary|Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course|The number of participants with a CD8+ cell count greater than or equal to the lower limit of normal (LLN; reference range 0.11 to 0.66 gill per liter) or the baseline value (whichever was lower) is presented. The baseline assessment is defined as the start of the Double-blind Period.|From baseline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.||Participants|||Number
756737|NCT00603525|Secondary|Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course|The number of participants with a CD4+ cell count greater than or equal to the lower limit of normal (LLN; reference range 0.11 to 0.66 gill per liter) or the baseline value (whichever was lower) is presented. The baseline assessment is defined as the start of the Double-blind Period.|From baseline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.||Participants|||Number
756738|NCT00603525|Secondary|Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course|The number of participants with a CD3+ cell count greater than or equal to the lower limit of normal (LLN; reference range 0.11 to 0.66 gill per liter) or the baseline value (whichever was lower) is presented. The baseline assessment is defined as the start of the Double-blind Period.|From baseline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.||Participants|||Number
756739|NCT00603525|Secondary|Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at Indicated the Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course|The number of participants with a CD19+ cell count greater than or equal to the lower limit of normal (LLN; reference range 0.11 to 0.66 giga [10^9] per liter) or the baseline value (whichever was lower) is presented. The baseline assessment is defined as the start of the Double-blind Period.|From baseline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.||Participants|||Number
756740|NCT00603525|Secondary|Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period|The number of participants with normal, abnormal clinically significant (CS), and abnormal not clinically significant (NCS) ECG findings, as well as the number of participants with no results (NR), during the OL Period are presented. An overall interpretation of the ECG was made by the investigator, or the investigator could delegate this task to a cardiologist, if applicable.|From DB Period completion (Week 24) until the completion of the OL Period, assessed up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.||Participants|||Number
756741|NCT00603525|Secondary|Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event, During the DB and OL Periods, by Ofatumumab Treatment Course|An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; or is a congenital anomaly/birth defect. Medical or scientific judgment should have been exercised in other situations. Refer to the general AE/SAE module for a list of AEs (occurring at a frequency threshold >=2%) and SAEs.|First treatment (Day 0) until the participant terminated the trial, assessed up to Week 144|AT Population||Participants|||Number
756742|NCT00603525|Secondary|Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using CRP), During the DB and OL Periods, by Ofatumumab Treatment Course|The DAS28 is a clinical index of rheumatoid arthritis disease activity that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of disease activity can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. Remission is defined as a DAS28 score <2.6 at any time during the first 24 weeks of each treatment course. Low disease activity is defined as a DAS28 score >=2.6 and <3.2 at any time during the first 24 weeks of each treatment course.|First 24 weeks of each treatment course (assessed up to Week 144)|AT Population||participants|||Number
756750|NCT00603525|Secondary|Number of Participants With Positive Human Anti-human Antibodies (HAHA) at Week 24|Detection of human anti-human antibodies (HAHAs) against ofatumumab was to be performed by Electrochemiluminescent (ECL) Meso-Scale Discovery (MSD) immunoassay. Positive samples from the binding antibody test were also tested in a neutralizing antibody assay.|Baseline and Week 24|ITT Population. This trial was terminated prematurely due to the Sponsor's decision to not pursue clinical development of the IV formulation of ofatumumab in an autoimmune indication; thus, no participants were analyzed for this endpoint.|||||
756971|NCT00605085|Primary|Safety and Tolerability up to Day 56|calculation based on safety population, numbers provide percentages of participants with Adverse Events (AEs)|Day 56|Safety Population||percentage of participants with AEs|||Number
756743|NCT00603525|Secondary|Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using ESR), During the DB and OL Periods, by Ofatumumab Treatment Course|The DAS28 is a clinical index of rheumatoid arthritis disease activity that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of disease activity can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. Remission is defined as a DAS28 score <2.6 at any time during the first 24 weeks of each treatment course. Low disease activity is defined as a DAS28 score >=2.6 and <3.2 at any time during the first 24 weeks of each treatment course.|First 24 weeks of each treatment course (assessed up to Week 144)|AT Population||participants|||Number
756744|NCT00603525|Secondary|Time to Retreatment, by Ofatumumab Treatment Course|Time to retreatment is defined as the time in days between infusion A of each treatment course and infusion A of the following treatment course. For participants randomized to ofatumumab in the Double-blind Period, Treatment Course 1 refers to the course of ofatumumab received in the Double-blind Period. The minimum period allowed per protocol before retreatment was 24 weeks (end of Double-blind Period). For participants randomized to placebo in the Double-blind Period, Treatment Course 1 refers to the first course of ofatumumab received in the Open-label Period. The minimum period allowed per protocol before retreatment during the Open-label Period was 16 weeks.|From Baseline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.||Days||Standard Deviation|Mean
756745|NCT00603525|Secondary|Minimum Change From Baseline DAS28-CRP Score, During the DB and OL Periods, by Ofatumumab Treatment Course|The level of rheumatoid arthritis disease activity based on the DAS28 score is defined as low if DAS28 <=3.2, moderate if 3.2< DAS28 <=5.1, or high if DAS28 > 5.1. A DAS28 <2.6 corresponds to clinical remission. The values summarized are the minimum change from baseline DAS28 score (i.e. greatest change in disease activity during the treatment course) achieved by each participant within the first 24 weeks of each treatment course, assessed by using CRP. Baseline score was determined at the start of each treatment course. For change from baseline, participants had to have both a baseline DAS28 value for the treatment course (i.e., the latest value on or before the date of infusion A of the treatment course, providing it was done within a 14 day window prior to the date of infusion A) and a DAS28 value during the treatment course (i.e., during first 24 weeks of each treatment course). Change from baseline was calculated as the value during the treatment course minus the baseline value.|First 24 weeks of each treatment course (assessed up to Week 144)|AT Population. Only those participants contributing values at the indicated time point were analyzed.||scores on a scale||Standard Deviation|Mean
756746|NCT00603525|Secondary|Minimum Change From Baseline DAS28-ESR Score, During the DB and OL Periods, by Ofatumumab Treatment Course|The level of rheumatoid arthritis disease activity based on the DAS28 score is defined as low if DAS28 <=3.2, moderate if 3.2< DAS28 <=5.1, or high if DAS28 > 5.1. A DAS28 <2.6 corresponds to clinical remission. The values summarized are the minimum change from baseline DAS28 score (i.e. greatest change in disease activity during the treatment course) achieved by each participant within the first 24 weeks of each treatment course, assessed by using ESR. Baseline score was determined at the start of each treatment course. For change from baseline, participants had to have both a baseline DAS28 value for the treatment course (i.e., the latest value on or before the date of infusion A of the treatment course, providing it was done within a 14 day window prior to the date of infusion A) and a DAS28 value during the treatment course (i.e., during first 24 weeks of each treatment course). Change from baseline was calculated as the value during the treatment course minus the baseline value.|First 24 weeks of each treatment course (assessed up to Week 144)|AT Population. Only those participants contributing values at the indicated time point were analyzed.||scores on a scale||Standard Deviation|Mean
756747|NCT00603525|Secondary|Minimum DAS28-CRP Score During the DB and OL Periods, by Ofatumumab Treatment Course|The DAS28 is a clinical index of rheumatoid arthritis disease activity that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of disease activity can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. The values summarized are the minimum DAS28 score (i.e. lowest level of disease activity) achieved by each participant within the first 24 weeks of each treatment course, assessed using C-reactive Protein (CRP: used to monitor acute inflammatory phases of rheumatoid arthritis).|First 24 weeks of each treatment course (assessed up to Week 144)|AT Population||scores on a scale||Standard Deviation|Mean
756748|NCT00603525|Secondary|Minimum DAS28-ESR Score During the DB and OL Periods, by Ofatumumab Treatment Course|The DAS28 is a clinical index of rheumatoid arthritis disease activity that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of disease activity can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. The values summarized are the minimum DAS28 score (i.e. lowest level of disease activity) achieved by each participant within the first 24 weeks of each treatment course (TC), assessed using erythrocyte sedimentation rate (ESR; rate at which red blood cells sediment in 1 hour).|First 24 weeks of each treatment course (assessed up to Week 144)|As Treated (AT) Population: all participants who received at least one infusion of ofatumumab in the DB and/or OL Period||Scores on a scale||Standard Deviation|Mean
756749|NCT00603525|Secondary|Change From Baseline in Levels of IgA, IgG and IgM at Week 12 and Week 24|The following immunoglobulins were assessed: IgA, IgG and IgM. Immunoglobulins, or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Low levels indicate immuno-suppression.|Baseline, Week 12, and Week 24|Safety Population: identical to the ITT population except that participants were analyzed according to their actual treatment when this differed from their randomized treatment. Only those participants contributing values at baseline and the relevant visit were analzyed.||grams per Liter (g/L)||Full Range|Median
756972|NCT00605150|Secondary|Occurrence of Unacceptable Side Effects After Treatment||6 months||||||
756751|NCT00603525|Secondary|Biomarker Levels for Anti-CCP, RF-IgA, RF-IgG, and RF-IgM at Baseline and Week 4|The following biomarkers were assessed: Anti-Cyclic Citrullinated Peptide 3 antibody (Anti-CCP), Rheumatoid factor IgA (RF-IgA), RF IgG (RF-IgG), and RF IgM (RF-IgM). Measurements of RF were used to characterize participants' disease activity and immune status. Anti-CCP was used to characterize the disease type and the immune status of the participants. Assessments for which results were below the lower limit of quantification (LLQ) were reported using a value of LLQ/2. Assessments for which results were above the upper limit of quantification (ULQ) were reported using a value of ULQ.|Baseline and Week 4|ITT Population. Only those participants contributing values at the relevant visit were analyzed.||Units/Liter||Full Range|Median
756752|NCT00603525|Secondary|Change From Baseline in the SF-36v2 Norm-based Scores for Mental Component Summary and Mental Items at Week 24|The SF-36v2 is a standardized questionnaire used to measure overall subjective health status by measuring 8 health-related parameters (each scored from 0 [poorer health] to 100 [better health]): body pain, general mental health (MH), perception of general health, physical functioning, role limitations (RL) caused by mental condition, RL caused by a physical condition, social functioning, and vitality. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and MH summary measures and a preference-based health utility index.|Baseline and Week 24|ITT Population. This trial was terminated prematurely due to the Sponsor's decision to not pursue clinical development of the IV formulation of ofatumumab in an autoimmune indication; thus, no participants were analyzed for this endpoint.|||||
756753|NCT00603525|Secondary|Change From Baseline in the Short-Form 36 (SF-36v2) Norm-based Scores for Physical Component Summary and Physical Items at Week 24|The SF-36v2 is a standardized questionnaire used to measure overall subjective health status by measuring 8 health-related parameters (each scored from 0 [poorer health] to 100 [better health]): body pain, general mental health (MH), perception of general health, physical functioning, role limitations (RL) caused by mental condition, RL caused by a physical condition, social functioning, and vitality. It yields an 8-scale profile of functional health and well-being scores, as well as psychometrically based physical and MH summary measures and a preference-based health utility index.|Baseline and Week 24|ITT Population. This trial was terminated prematurely due to the Sponsor's decision to not pursue clinical development of the IV formulation of ofatumumab in an autoimmune indication; thus, no participants were analyzed for this endpoint.|||||
756754|NCT00603525|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT) Questionnaire Score at Week 24|"The FACIT-F score has a valid range of values from 0 to 52, with a higher score indicating a lower burden of fatigue. The subset determining fatigue contains 13 questions. Responses to each question were scored from 0, indicating Not at all fatigued, to 4, indicating Very much fatigued."|Baseline and Week 24|ITT Population. This trial was terminated prematurely due to the Sponsor's decision to not pursue clinical development of the IV formulation of ofatumumab in an autoimmune indication; thus, no participants were analyzed for this endpoint.|||||
756755|NCT00603525|Secondary|Change From Baseline in the Physician-assessed Global Disease Score Using VAS at Week 24|"The physician used a horizontal VAS of 100 mm for overall assessment of disease. The scale ranged from 0 (very well) to 100 (very poor). Physicians were instructed to draw a vertical line through the horizontal line to indicate the state of the arthritis. The distance from the very well end to the vertical line drawn by the participant was the global disease assessment score. Change from baseline in the physician-assessed global disease was calculated as the Week 24 value minus the baseline value."|Baseline and Week 24|ITT Population. This trial was terminated prematurely due to the Sponsor's decision to not pursue clinical development of the IV formulation of ofatumumab in an autoimmune indication; thus, no participants were analyzed for this endpoint.|||||
756756|NCT00603525|Secondary|Change From Baseline in Participant-assessed Global Disease Score Using VAS at Week 24|"The participant used a horizontal VAS of 100 mm for overall assessment of disease. The scale ranged from 0 (very well) to 100 (very poor). Participants were instructed to draw a vertical line through the horizontal line to indicate the state of the arthritis. The distance from the very well end to the vertical line drawn by the participant was the global disease assessment score. Change from baseline in participant-assessed global disease was calculated as the Week 24 value minus the baseline value."|Baseline and Week 24|ITT Population. This trial was terminated prematurely due to the Sponsor's decision to not pursue clinical development of the IV formulation of ofatumumab in an autoimmune indication; thus, no participants were analyzed for this endpoint.|||||
756757|NCT00603525|Secondary|Change From Baseline in the Participant-assessed Pain Score Using Visual Analogue Scale (VAS) at Week 24|"A horizontal VAS of 100 mm was used to report the participant’s level of joint pain. The scale ranged from 0 (no pain) to 100 (unbearable pain). Participants were instructed to draw a vertical line through the horizontal line to indicate how much joint pain they had. The distance from the no pain end to the vertical line drawn by the participant was the joint pain score. Change from baseline was calculated as the Week 24 value minus the baseline value."|Baseline and Week 24|ITT Population. This trial was terminated prematurely due to the Sponsor's decision to not pursue clinical development of the IV formulation of ofatumumab in an autoimmune indication; thus, no participants were analyzed for this endpoint.|||||
756758|NCT00603525|Secondary|Change From Baseline in ESR at Week 24|ESR is measured by a blood test that shows the rate at which red blood cells sediment in a period of 1 hour. Blood samples for the determination of ESR were taken at pre-specified visits and were measured immediately at the trial site. Change from baseline in ESR was calculated as the Week 24 value minus the baseline value.|Baseline and Week 24|ITT Population. Only those participants contributing values at baseline and the relevant visit were analyzed.||millimeters per hour (mm/hr)||Full Range|Median
756759|NCT00603525|Secondary|Change From Baseline in CRP at Week 24|Blood samples for the determination of CRP were taken at pre-specified visits and were sent to the central laboratory for analysis. Change from baseline in CRP was calculated as the Week 24 value minus the baseline value. CRP is an acute-phase protein whose plasma concentration increases in response to inflammation. CRP is a useful marker of inflammation.|Baseline and Week 24|ITT Population. Only those participants contributing values at baseline and the relevant visit were analyzed.||milligrams per liter (mg/L)||Full Range|Median
756833|NCT00604188|Secondary|Responders at Day 28|Responders were the number of participants in each group who received the scheduled 8- to 24-mg dose of Suboxone at study visit day. A participant who discontinued from the study was treated as a non-responder at the timepoint after the participant discontinued.|28 days|ITT population||Participants|||Number
756760|NCT00603525|Secondary|Change From Baseline in Swollen Joint Count at Week 24|Change from baseline in swollen joint count was calculated as the Week 24 count minus the baseline count. A total of 66 joints were assessed. Joints were classified as either swollen or not swollen by an independent assessor, who had documented experience in performing joint assessments.|Baseline and Week 24|ITT Population. Only those participants contributing values at baseline and the relevant visit were analyzed.||swollen joints||Full Range|Median
756761|NCT00603525|Secondary|Change From Baseline in Tender Joint Count at Week 24|Change from baseline in tender joint count was calculated as the Week 24 count minus the baseline count. A total of 68 joints were assessed. Joints were classified as either tender or not tender by an independent assessor, who had documented experience in performing joint assessments.|Baseline and Week 24|ITT Population. Only those participants contributing values at baseline and the relevant visit were analyzed.||tender joints||Full Range|Median
756762|NCT00603525|Secondary|Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Weeks 4, 8, 12, 16, 20, and 24|The HAQ-DI is a 20-question instrument used to assess the degree of difficulty a participant had in accomplishing tasks in 8 functional areas (FAs): dressing, arising, eating, walking, hygiene, reaching, gripping, and errands/chores. Responses for each FA were scored from 0 (no difficulty) to 3 (inability to perform a task). The total score (range of 0-3) was calculated by adding the 8 individual FA scores, then dividing this sum by the total number of components answered. Responders were defined as participants achieving an improvement from baseline in the HAQ-DI score at Week 24 of >=0.22.|Weeks 4, 8, 12, 16, 20, and 24|ITT Population. Only those participants contributing values at baseline and the relevant visit were analyzed.||scores on a scale||Full Range|Median
756763|NCT00603525|Secondary|Median of the Largest Integer n, for Which a Participant Met the ACR Criteria Requiring an Improvement of n% (ACRn) at Weeks 4, 8, 12, 16, 20, and 24|ACRn = the largest integer n for which a participant (par.) met the criteria requiring an improvement of n%. ACRn is a measure characterizing percentage (%) improvement from baseline (IFBL). A par. with an ACRn of X had an improvement of >=X% in tender/swollen joints (TJC/SJC), and an improvement of >=X% in 3 of the 5 parameters (patient [pt] pain assessment, pt global assessment [GA], physician GA, pt self-assessed disability, acute phase reactant). ACRn = min(TJC % IFBL, SJC % IFBL, composite measure % IFBL). Composite measure % IFBL is the 3rd highest value of % IFBL for the 5 parameters.|Weeks 4, 8, 12, 16, 20, and 24|ITT Population. This trial was terminated prematurely due to the Sponsor's decision to not pursue clinical development of the IV formulation of ofatumumab in an autoimmune indication; thus, no participants were analyzed for this endpoint.|||||
756764|NCT00603525|Secondary|Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant|The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 <=3.2; moderate responders: change from baseline >1.2 with DAS28 <=3.2 to >5.1 or change from baseline >0.6 to <=1.2 with DAS28 <=3.2 to <=5.1); non-responders: change from baseline <=0.6 or change from baseline >0.6 and <=1.2 with DAS28 >5.1.|Baseline and Weeks 4, 8, 12, 16, 20, and 24|ITT Population||participants|||Number
756765|NCT00603525|Secondary|Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant|The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 <=3.2; moderate responders: change from baseline >1.2 with DAS28 <=3.2 to >5.1 or change from baseline >0.6 to <=1.2 with DAS28 <=3.2 to <=5.1); non-responders: change from baseline <=0.6 or change from baseline >0.6 and <=1.2 with DAS28 >5.1.|Baseline and Weeks 4, 8, 12, 16, 20, and 24|ITT Population||participants|||Number
756766|NCT00603525|Secondary|Change From Baseline in DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant|The DAS28 is a clinical index of rheumatoid arthritis disease activity (DA) that combines information from swollen and tender joints, the APR, and general health (patient global assessment). The level of DA can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. APRs are a class of proteins that are useful markers for inflammation. Change from baseline in DAS28 is calculated as the Week 4, 8, 12, 16, 20, and 24 values minus the baseline value.|Baseline and Weeks 4, 8, 12, 16, 20, and 24|ITT Population. Only those participants contributing values at baseline and the relevant visit were analyzed.||scores on a scale||Standard Deviation|Mean
756767|NCT00603525|Secondary|Mean DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using Erythrocyte Sedimentation Rate (ESR) as the Acute Phase Reactant (ARP)|The DAS28 is a clinical index of rheumatoid arthritis disease activity (DA) that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of DA can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. APRs are a class of proteins that are useful markers for inflammation.|Weeks 4, 8, 12, 16, 20, and 24|ITT Population. Only those participants contributing values at the relevant visit were analyzed.||scores on a scale||Standard Deviation|Mean
756768|NCT00603525|Secondary|Change From Baseline in DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant|The DAS28 is a clinical index of rheumatoid arthritis disease activity (DA) that combines information from swollen and tender joints, the APR, and general health (patient global assessment). The level of DA can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. APRs are a class of proteins that are useful markers for inflammation. Change from baseline in DAS28 is calculated as the Week 4, 8, 12, 16, 20, and 24 values minus the baseline value.|Baseline and Weeks 4, 8, 12, 16, 20, and 24|ITT Population. Only those participants contributing values at baseline and the relevant visit were analyzed.||scores on a scale||Standard Deviation|Mean
756834|NCT00604188|Secondary|Compliance Rate|Compliance rate was calculated as the number of days study medication was taken divided by the number of days study medication should have been taken X 100. The number of days study medication should have been taken was equal to the duration of treatment.|28 days|ITT population||Percentage of days||Standard Deviation|Mean
756973|NCT00605150|Primary|Progression|Progression of liver cancer|6 months|Number of participants enrolled||participants|||Number
756769|NCT00603525|Secondary|Mean Disease Activity Score Based on 28 Joints (DAS28) at Weeks 4, 8, 12, 16, 20, and 24 Using C-reactive Protein (CRP) as the Acute Phase Reactant (APR)|The DAS28 is a clinical index of rheumatoid arthritis disease activity (DA) that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of DA can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. APRs are a class of proteins that are useful markers for inflammation.|Weeks 4, 8, 12, 16, 20, and 24|ITT Population. Only those participants contributing values at the relevant visit were analyzed.||scores on a scale||Standard Deviation|Mean
756770|NCT00603525|Secondary|Number of Participants With a 70% Improvement From Baseline in Their ACR Score (ACR70) at Weeks 4, 8, 12, 16, 20, and 24|The ACR score was based on improvement from baseline in tender (TJC) and swollen joint counts (SJC). A participant had achieved ACR70 if he experienced >=70% improvement from baseline in TJC and SJC and a >=70% improvement from baseline in 3 out of 5 of the following assessments: participant pain assessment on a 100 millimeter (mm) visual analog scale (VAS), participant global assessment on a 100 mm VAS scale, physician global assessment on a 100 mm VAS scale, participant self-assessed disability, and C-reactive protein.|Baseline and Weeks 4, 8, 12, 16, 20, and 24|ITT Population||participants|||Number
756771|NCT00603525|Secondary|Number of Participants With a 50% Improvement From Baseline in Their ACR Score (ACR50) at Weeks 4, 8, 12, 16, 20, and 24|The ACR score was based on improvement from baseline in tender (TJC) and swollen joint counts (SJC). A participant had achieved ACR50 if he experienced >=50% improvement from baseline in TJC and SJC and a >=50% improvement from baseline in 3 out of 5 of the following assessments: participant pain assessment on a 100 millimeter (mm) visual analog scale (VAS), participant global assessment on a 100 mm VAS scale, physician global assessment on a 100 mm VAS scale, participant self-assessed disability, and C-reactive protein.|Baseline and Weeks 4, 8, 12, 16, 20, and 24|ITT Population||participants|||Number
756772|NCT00603525|Secondary|Number of Participants With a 20% Improvement From Baseline in Their American College of Rheumatology (ACR) Score (ACR20) at Weeks 4, 8, 12, 16, and 20|The ACR score was based on improvement from baseline in tender (TJC) and swollen joint counts (SJC). A participant had achieved ACR20 if he experienced >=20% improvement from baseline in TJC and SJC and a >=20% improvement from baseline in 3 out of 5 of the following assessments: participant pain assessment on a 100 millimeter (mm) visual analog scale (VAS), participant global assessment on a 100 mm VAS scale, physician global assessment on a 100 mm VAS scale, participant self-assessed disability, and C-reactive protein.|Baseline and Weeks 4, 8, 12, 16, and 20|ITT Population||participants|||Number
756773|NCT00603525|Primary|Number of Participants With a 20% Improvement From Baseline in Their American College of Rheumatology (ACR) Score (ACR20) at Week 24|The ACR score was based on improvement from baseline in tender (TJC) and swollen joint counts (SJC). A participant had achieved ACR20 if he experienced >=20% improvement from baseline in TJC and SJC and a >=20% improvement from baseline in 3 out of 5 of the following assessments: participant pain assessment on a 100 millimeter (mm) visual analog scale (VAS), participant global assessment on a 100 mm VAS scale, physician global assessment on a 100 mm VAS scale, participant self-assessed disability, and C-reactive protein.|Baseline and Week 24|Intent-to-Treat (ITT) Population: all randomized participants who were exposed to investigational product irrespective of their compliance to the planned course of treatment. Participants were analyzed according to their randomized treatment.||participants|||Number
756774|NCT00603538|Secondary|Progression-Free Survival (PFS)|PFS is the period from the registration to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first.|Baseline up to 6 cycles (1 cycle = 21 days)|Number of participants with defined event (all causality death or PD) was too few to conduct summary analysis.|||||
756775|NCT00603538|Secondary|Number of Participants With Objective Response|Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.|Baseline up to 6 cycles (1 cycle = 21 days)|Full Analysis Set (FAS) was defined as all participants who met all of the following criteria; 1) Those who were diagnosed with NSCLC, 2) Those who received at least one dose of the study treatment, and 3) Those who had efficacy data after the start of the study treatment.||participants|||Number
756776|NCT00603538|Secondary|Number of Participants With Positive Anti-Drug Antibody (ADA) Specific to CP-751,871 Following an Intravenous Infusion of CP-751,871.|The screening assay for anti-CP-751,871 antibodies was performed.|Day 1 of Cycles 1 (predose) and 4, and end of study|All participants were screened for the ADA.||participants|||Number
756777|NCT00603538|Secondary|Serum Concentrations of Total Insulin-like Growth Factor Binding Protein-3 (IGF-BP-3)|IGF-BP3 is one of the IGF-axis related biomarkers.|Day 1 of Cycles 1-6, Day 8 of Cycles 1-4, and end of treatment|Safety Analysis Set was defined as all participants who have received at least one dose of the study medication. n = number of subjects evaluable.||mg/L||Standard Deviation|Mean
756778|NCT00603538|Secondary|Serum Concentrations of Total Insulin-like Growth Factor 1 (IGF-1)|IGF-1 is one of the IGF-axis related biomarkers.|Day 1 of Cycles 1 to 6, Day 8 of Cycles 1 to 4, and end of study|Safety Analysis Set was defined as all participants who have received at least one dose of the study medication. n = number of subjects evaluable.||ng/L||Standard Deviation|Mean
756779|NCT00603538|Secondary|Observed Accumulation Ratio (Rac)|The ratio of Cycle 4 AUCtau to Cycle 1 AUCtau|Cycle 1 and Cycle 4: prior to CP-751,871 (Day 1) dosing, and 1, 24, 72 and 168 (Day 8) hours after end of CP-751,871 infusion|The Pharmacokinetics Analysis Set was defined as all participants who started treatment and had sufficient information for estimation of pharmacokinetic parameters.||ratio||Standard Deviation|Mean
756780|NCT00603538|Secondary|Area Under the Plasma Concentration Curve From Time Zero to Tau (AUCtau)|AUCtau: AUC from time zero to tau, the dosing interval, where tau is the actual time of the predose sampling for the next cycle. AUCtau was calculated using the linear/log trapezoidal method.|Cycle 4: prior to CP-751,871 (Day 1) dosing , and 1, 24, 72 and 168 (Day 8) hours after end of CP-751,871 infusion|The Pharmacokinetics Analysis Set was defined as all participants who started treatment and had sufficient information for estimation of pharmacokinetic parameters.||mg*h/mL||Standard Deviation|Mean
756781|NCT00603538|Secondary|Area Under the Plasma Concentration-time Curve From Time 0 to Day 22 (AUC0-day22)|AUC(0-day22) : AUC from time zero (Day 1) to Day 22, where Day 22 is the nominal time (504 hours) of the predose sampling for the next cycle. AUC(0-day22) was calculated using the linear/log trapezoidal method.|Cycle 1: prior CP-751,871 (Day 1) to dosing, and 1, 24, 72 and 168 (Day 8) hours after end of CP-751,871 infusion|The Pharmacokinetics Analysis Set was defined as all participants who started treatment and had sufficient information for estimation of pharmacokinetic parameters.||mg*h/L||Standard Deviation|Mean
756782|NCT00603538|Secondary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Cycle 1 : prior to CP-751,871 (Day 1) dosing, and 1, 24, 72 and 168 (Day 8) hours after end of CP-751,871 infusion|Participants with sufficient sampling to capture the terminal disposition phase were analyzed.||hours||Standard Deviation|Mean
756783|NCT00603538|Secondary|Maximum Observed Concentration (Cmax) of CP-751,871||Cycles 1 and 4 at prior to dosing of CP-751,871 (Day 1), and 1, 24, 72 and 168 (Day 8) hours after end of CP-751,871 infusion|"The Pharmacokinetics Analysis Set was defined as all participants who started treatment and had sufficient information for estimation of pharmacokinetic parameters.
n = the number of participants analyzed"||mg/L||Standard Deviation|Mean
756784|NCT00603538|Primary|Number of Participants With Dose Limiting Toxicities (DLT)|A DLT was defined as any one of the following adverse events observed in Cycle 1 which was considered as related to CP-751,871 combination therapy; 1) >=Grade 3 gastrointestinal toxicity, hyperglycemia and/or fatigue despite the use of adequate/optimal medical intervention, 2) Any other >=Grade 3 toxicity not classified under CTCAE blood/bone marrow, or 3) Grade 4 neutropenia that persisted for >=7 consecutive days or was complicated by fever (defined as a body temperature >38.0 Celsius degree), 4) Grade 3 thrombocytopenia which needed blood transfusion or Grade 4 thrombocytopenia.|Cycle 1|DLT Evaluation Set comprised of participants who were treated with CP-751,871. One participant in the 10 mg/kg cohort who discontinued from the study due to an adverse event occurred prior to CP-751,871 administration was excluded from this analysis set.||participants|||Number
756785|NCT00603564|Secondary|PaO2/FiO2 Ratio Mantainance|the number of subjects who could maintain, once reached, a PaO2/FiO2 ratio ≥315 at 1 and 24 hours after the qualifying measurement|1, 6, 12, 24 and 48 hours|||participants|||Number
756786|NCT00603564|Primary|Time to Reach an Improvement in Terms of Gas Exchange, Defined as a PaO2/FiO2 Ratio ≥315||on admission and at 1, 6, 12, 24 and 48 hours until PaO2/FiO2 ratio ≥315|||minute||Standard Deviation|Mean
756787|NCT00603590|Secondary|LDL Cholesterol|Serum LDL cholesterol|One year|Intention to treat Results shown here are based on 12 month observation. Analysis for final paper will be last observation carried forward||mg/dL||Standard Deviation|Mean
756788|NCT00603590|Secondary|Diastolic Blood Pressure|Mean of two seated diastolic blood pressures|One year|Analysis by intention to treat. Results shown here are based on 12 month observation. Analysis for final paper will be last observation carried forward.||mm Hg||Standard Deviation|Mean
756789|NCT00603590|Primary|Systolic Blood Pressure|Systolic blood pressure. Mean of two seated measurements.|One year|Intention to treat Results shown here are based on 12 month observation. Analysis for final paper will be last observation carried forward||mm Hg||Standard Deviation|Mean
756790|NCT00603642|Secondary|Rescue Medication(s)|Requirement for rescue medication(s) during treatment by the participant|12 weeks (Weeks 2 - 13)|Full Analysis Set, composed of all randomized participants who received at least 1 dose of romiplostim or placebo||Participants|||Number
756791|NCT00603642|Secondary|Weeks With Platelet Count Between 50 and 200|Number of weeks with platelet count between 50 x 10^9/L and 200 x 10^9/L inclusive during week 2 to week 13.|12 weeks (Weeks 2 - 13)|Full Analysis Set, composed of all randomized participants who received at least 1 dose of romiplostim or placebo||Weeks||Standard Deviation|Mean
756792|NCT00603642|Secondary|Change From Baseline in Mean of Last 4 Weekly Platelet Counts|Change from baseline in the mean of the last 4 weekly platelet counts from week 2 to week 13.|12 weeks (Weeks 2 - 13)|Full Analysis Set, composed of all randomized participants who received at least 1 dose of romiplostim or placebo||10^9/L||Standard Deviation|Mean
756793|NCT00603642|Secondary|Increased Platelet Count From Baseline of at Least 20 x 10^9/L|An increase in platelet count of at least 20 x 10^9/L from baseline within the participant during the treatment period. Increase was calculated as the maximum observed platelet count during the treatment period minus the baseline platelet count.|Baseline, 12 weeks (Weeks 2 - 13)|Full Analysis Set, composed of all randomized participants who received at least 1 dose of romiplostim or placebo||Participants|||Number
756794|NCT00603642|Primary|Weeks With Weekly Platelet Response|Number of weeks with weekly platelet response. A weekly platelet response is defined as a platelet count of ≥ 50 x 10^9/L on a weekly scheduled dose day from week 2 to week 13.|12 weeks (Weeks 2 - 13)|Full Analysis Set, composed of all randomized participants who received at least 1 dose of romiplostim or placebo||Weeks||Inter-Quartile Range|Median
756795|NCT00603993|Secondary|Duration (Minutes) of the Presence of Morning Stiffness by Visit|Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in the duration (minutes) of stiffness in the morning.|Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)|Subjects were included in this analysis if they had morning stiffness at baseline. Analysis results are as-observed.||minutes||Standard Deviation|Mean
756796|NCT00603993|Secondary|Presence of Morning Stiffness by Visit|The number of subjects with morning stiffness at each visit among those who had morning stiffness at baseline (64).|Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)|Subjects were included in this analysis if they had morning stiffness at baseline. Analysis results are as-observed.||participants|||Number
756797|NCT00603993|Secondary|Mean Change From Baseline in C-reactive Protein (CRP), a Component of the ACR Criteria by Visit|Mean change from baseline(for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in CRP (mg/dL), a component of the ACR criteria, by visit|Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final Value)|||mg/dL||Standard Deviation|Mean
756876|NCT00604695|Secondary|Safety Endpoint: Number of Patients Who Developed Cardiac Arrhythmias||Through 30days following primary percutaneous coronary intervention|Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo)||participants|||Number
756798|NCT00603993|Secondary|Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ), a Component of the ACR Criteria, by Visit|Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in disability index of the HAQ (includes 20 questions assessing physical function in 8 domains. The questions are evaluated on a scale from 0 - 3 to measure the ability to perform certain activities [0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do so]), a component of the ACR criteria by visit|Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)|||units on a scale||Standard Deviation|Mean
756799|NCT00603993|Secondary|Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Pain), a Component of the ACR Criteria, by Visit|Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in subject's assessment of pain (on a visual analog scale from 0 - 100 mm with 100 mm being the worst pain), a component of the ACR criteria, by visit|Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final Value)|||mm on a scale||Standard Deviation|Mean
756800|NCT00603993|Secondary|Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Assessment), a Component of the ACR Criteria, by Visit|mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in subjects global assessment of disease activity (a visual analog scale from 0 - 100 mm with 100 mm being the worst case), a component of the ACR criteria, by visit|Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)|||mm on a scale||Standard Deviation|Mean
756801|NCT00603993|Secondary|Mean Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Assessment), a Component of the ACR Criteria, by Visit|Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in PGA (a visual analog scale from 0 - 100 mm with 100 mm being the worst case), a component of the ACR criteria, by visit|Every 4 weeks weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)|||mm on a scale||Standard Deviation|Mean
756802|NCT00603993|Secondary|Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria by Visit|Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in SJC (max = 66), a component of the ACR criteria, by visit|Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)|||SJC||Standard Deviation|Mean
756803|NCT00603993|Secondary|Mean Change From Baseline in Tender Joint Count (TJC; Max = 68), a Component of the ACR Criteria, by Visit|Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in TJC (max = 68), a component of the ACR criteria, by visit|Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)|||TJC||Standard Deviation|Mean
756804|NCT00603993|Primary|Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)|Number of responders with ACR criteria improvement consisting of 20%, 50%, and 70% (ACR20, ACR50, and ACR70, respectively) reduction in tender or swollen joint counts (TJC or SJC, respectively) and 20%, 50%, and 70% improvement, respectively, in 3 of the following 5 criteria: [1] physician's global assessment of disease activity (PGA), [2] subject's assessment of disease activity, [3] subject's assessment of pain, [4] subject's assessment of physical disability via a health assessment questionnaire disability index(HAQ-DI), and [5] C-reactive protein (CRP) at each visit.|Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)|Analysis was based on observed data.||participants|||Number
756805|NCT00604019|Secondary|Safety, Arrythmia - Yes or no for Each Group||28 days||||||
756806|NCT00604019|Primary|Efficacy|Dead at 28 days|28 days|||participants|||Number
756807|NCT00604045|Primary|Post-Traumatic Stress Disorder Checklist-Military Version (PCL-M)|The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. Scores range from 0 to 80, with higher scores indicating more severe symptoms.|Pre-Treatment, Post-Treatment (after 4 weeks of treatment)|||units on a scale||Standard Deviation|Mean
756808|NCT00604162|Primary|Specificity of Capsule Endoscopy for Indicated Lesions|Readings of videos from the PillCam COLON were performed by trained physicians who identified lesions (types and sizes). Specificity was calculated as the percentage of participants who had negative findings on capsule endoscopy (of a specified category) among participants with negative colonoscopy findings of the same category (reported in Outcome Measure 1). This corresponds to 1 - the false positive rate.|1 day|Accuracy Analysis population had both successful capsule endoscopy and colonoscopy.||Percentage of Participants||95% Confidence Interval|Number
756809|NCT00604162|Secondary|Colon Capsule Endoscopy Transit Time Per Section (Stomach, Small Bowel, Colon)||within 7 days||||||
756810|NCT00604162|Primary|Sensitivity of Capsule Endoscopy for Indicated Lesions|Readings of videos from the PillCam COLON were performed by trained physicians who identified lesions (types and sizes). Sensitivity was calculated as the percentage of participants who had positive findings on capsule endoscopy (of a specified category) among those participants who had positive findings on colonoscopy of the same category (reported in Outcome Measure 1). The false negative rate is equal to 1 - sensitivity and indicated the percentage of lesions missed by capsule endoscopy.|1 day|Accuracy Analysis population had both successful capsule endoscopy and colonoscopy.||Percentage of Participants||95% Confidence Interval|Number
756877|NCT00604695|Secondary|Safety Endpoint: Number of Patients Who Developed Thrombolysis In Myocardial Infarction (TIMI) Minimal Bleeding||Through 30days following primary percutaneous coronary intervention|Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo)||participants|||Number
757300|NCT00607672|Secondary|Blood Product Transfusion Requirement|Percentage of patients that received blood product transfusion|From the start of surgery until discharge from hospital|||percentage of patients|||Number
756811|NCT00604162|Primary|Number of Participants With Indicated Lesions Detected by Standard Colonoscopy|"Since the standard colonoscopy is the gold standard to which the PillCam is to be compared, the number of participants with the indicated lesions identified by a trained clinician using standard colonoscopy procedures is reported here. Note that some Participants had multiple lesions and so could be included in more than one size category. Advanced adenoma is defined as 1) an adenoma 1 cm or larger or 2) an adenoma with villous features or high-grade dysplasia. All colorectal cancers were 6mm or larger."|1 day|Participants in the Accuracy Analysis successfully had both capsule endoscopy and colonoscopy.||participants|||Number
756812|NCT00604162|Secondary|Percentage of Excreted Colon Capsules||Within 7 days||||||
756813|NCT00604162|Secondary|Accuracy Parameters (Sensitivity, Specificity, Negative Predicted Value, Positive Predicted Value) of Colon Capsule Endoscopy, Compared to Standard Colonoscopy||within 7 days||||||
756814|NCT00604162|Secondary|Number, Type and Severity of Adverse Events||Within 7 days||||||
756815|NCT00604162|Secondary|Percent of Participants With Scoring Index 3 or 4|"Overall colon cleanliness was judged for capsule endoscopy and colonoscopy on a four-point grading index scale as follows:
poor cleansing level (Large amount of fecal residue.)
fair cleansing level (Enough feces or dark fluid present to preclude a completely reliable examination.)
good cleansing level (Small amount of feces or dark fluid, but not enough to interfere with examination.)
excellent cleansing level (No more than small bits of adherent feces.)"|1 day|||Percentage of Participants||95% Confidence Interval|Number
756816|NCT00604162|Primary|Number of Participants With Successful Capsule Endoscopies or Standard Colonoscopies|The number of participants that completed the capsule endoscopy procedure with video images of the entire colon that could be read by a clinician, or subsequently had a full colonoscopy with visualization by a different clinician. The number of successful procedures of each type are reported.|1 day|||participants|||Number
756878|NCT00604695|Secondary|Safety Endpoint: Number of Patients Who Developed Thrombolysis In Myocardial Infarction (TIMI) Minor Bleeding||Through 30days following PPCI|Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo)||participants|||Number
766388|NCT00687076|Secondary|Effect of Intensive Lipid Modification Medication Therapy on Thrombosis, and Relationship to PAD Progression, Restenosis, and Clinical Events||Measured at baseline and Months 6, 12, and 24||||||
756835|NCT00604188|Secondary|Addiction-related Severity Index (ASI-Lite): A Composite Score to Evaluate Seven Potential Problem Areas: Medical, Employment/Support Status, Alcohol, Drug, Legal, Family/Social, and Psychiatric|"The ASI-Lite is a standardized, multidimensional, semi-structured, comprehensive interview that estimates addiction-related problem severity profiles in seven domains commonly affected in substance abusers. ASI-lite composite score ranges from 0 (worst outcome) to 1 (best outcome) for each category. Reported here is the change in ASI-Lite from baseline to Day 28.
The original drug use accounts for heroin, methadone, other opiates, analgesics, medicine/pills, cocaine, amphetamines, cannabis, hallucinogens, and inhalants. Modified drug use accounts for heroin, methadone, cocaine, and cannabis."|Baseline and 28 days|ITT population.||Score on a scale||Standard Error|Least Squares Mean
756836|NCT00604188|Secondary|Observer-rated Opioid Withdrawal Symptoms (OOWS)|The OOWS were 13 physically observable signs that were present (scored 1) or absent (scored 0). A total score of 0 represented the best outcome and a total score of 13 represented the worst outcome. Participants were scored for OOWS at baseline (prior to randomization) and on Day 28. Reported are the total score for Day 28, and the change in scores from baseline to Day 28.|Baseline and 28 days|Participants with OOWS data reviewed for completeness and within visit date consistency were analyzed.||Score on a scale||Standard Deviation|Mean
756837|NCT00604188|Secondary|Self-reported Opioid Withdrawal Symptoms (SOWS)|SOWS were 16 items whose intensity was scored on a scale from 0 (not at all) to 4 (extremely) for a maximum possible score of 64. A total score of 0 represented the best outcome and a score of 64 represented the worst outcome. Participants were scored for SOWS at baseline (prior to randomization) and on Day 28. Reported are the scores for Day 28, and the change in scores from baseline to Day 28.|Baseline and 28 days|Participants with SOWS data reviewed for completeness and within visit date consistency were analyzed.||Score on a scale||Standard Deviation|Mean
756838|NCT00604188|Secondary|Illicit Opioid and Non-opioid Drug Use: Substance Use Inventory (SUI)|Number of participants with intravenous use of drug as measured by self-reported SUI from Days 3-28. The SUI form consisted of questions addressing the number of days and times a drug was used, and the route of drug use. For suboxone the use of scheduled study medication was not considered illicit use.|Days 3 to 28|ITT population||Participants|||Number
756839|NCT00604188|Secondary|Illicit Opioid and Non-opioid Drug Use: Urine Drug Screen (UDS)|Number of participants who tested negative on UDS during open-label phase on Day 28. The drugs screened on Day 28 included amphetamines, methamphetamines, cocaine, morphine, methadone, benzodiazepines, and tetrahydrocannabinol. Buprenorphine was only tested at screening and randomization according to protocol, therefore no values for buprenorphine are available for Day 28.|28 days|Participants with missing data were not included in the analysis.||Participants|||Number
756840|NCT00604188|Primary|Responders at Day 3|"Responders included the number of participants who received the scheduled dose of Suboxone at the Day 3 study visit. Participants who discontinued the study at Day 3 were considered non-responders.
All participants that continued the study received Suboxone tablets on Day 3."|3 days|ITT population||Participants|||Number
756841|NCT00604214|Secondary|Percentage of Participants Discontinued Due to Adverse Events Any Time From Baseline Through Day 28 Endpoint||Baseline through Day 28|Participants who received study drug.||percentage of participants|||Number
756842|NCT00604214|Other Pre-specified|Percentage of Participants With Serious Bleeding Events Within System Organ Class Any Time From Baseline Through Day 28|Percentage of participants who experienced serious bleeding events are reported by System Organ Class (SOC) term based on MedDRA 14.0. For a bleeding to qualify as a serious event, it would have to meet the standard definition of a serious adverse event or be a central nervous system bleeding or a bleeding event that lead to administration of ≥3 units packed red blood cells/day for 2 consecutive days.|Baseline through Day 28|Participants who received study drug.||percentage of participants|||Number
756843|NCT00604214|Secondary|Quality of Life Short Form-12 (SF-12) Scores at Baseline, Days 28, 90 and 180|SF-12 was used as an instrument to measure participants’ physical wellbeing (physical component) and mental wellbeing (mental component). Scores for each component range from 0-100, with 0= lowest wellbeing, and 100=highest wellbeing.|Baseline and Days 28 and 90 and 180|All randomized participants with SF-12 score data at the specified time points.||units on a scale||Standard Deviation|Median
756844|NCT00604214|Secondary|EuroQoL Questionnaire-5 Dimensions (EQ-5D) Total Scores at Baseline, Days 28, 90 and 180|The EQ-5D is used to assess participant's overall health. Consists of 5 items: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each item has 3 severity levels (no, some, severe problems). Calculated from EQ-5D, total scores (United States [US] Index Score) range from 0 (worst quality of life) to 1.00 (best quality of life).|Baseline and Days 28 and 90 and 180|All randomized participants with EQ-5D total score data at the specified time points.||units on a scale||Standard Deviation|Mean
756845|NCT00604214|Secondary|EuroQoL Questionnaire-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) Scores at Baseline, Days 28, 90 and 180|EQ-5D VAS assesses caregiver's impression of participant's overall health state. Scores range from 0 (worst health state) to 100 (best health state), with higher scores indicating a better health state.|Baseline and Days 28 and 90 and 180|All randomized participants with EQ-5D VAS data at the specified time points.||units on a scale||Standard Deviation|Mean
756846|NCT00604214|Secondary|Median Survival Time||Day 180|All randomized participants excluding those with unknown mortality status at Day 180.||days||Full Range|Median
756847|NCT00604214|Secondary|180-Day Mortality|Expressed as percentage of participants who died from any cause at Day 180 endpoint.|Day 180|All randomized participants with known mortality status at Day 180.||percentage of participants|||Number
756848|NCT00604214|Secondary|90-Day Mortality|Expressed as percentage of participants who died from any cause at Day 90 endpoint.|Day 90|All randomized participants with known mortality status at Day 90.||percentage of participants|||Number
756849|NCT00604214|Secondary|Average Renal Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28|Scores range from 0 (normal) to 4 (organ failure) with an increasing score indicating increasing renal dysfunction. A non-surviving participant receives a score of 4 (worst score) for the day of death and every day thereafter.|Day 1 through Day 28|All randomized participants with any post-baseline data on Day 1 through Day 28. For those days when a participant is alive, but no data are available, last observation carried forward (LOFC) is used to impute the missing data. A non-surviving participant receives a score of 4 (worst score) for the day of death and every day thereafter.||units on a scale||Standard Deviation|Mean
756850|NCT00604214|Secondary|Average Respiratory Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28|Scores range from 0 (normal) to 4 (organ failure) with an increasing score indicating increasing respiratory dysfunction. A non-surviving participant receives a score of 4 (worst score) for the day of death and every day thereafter.|Day 1 through Day 28|All randomized participants with any post-baseline data on Day 1 through Day 28. For those days when a participant is alive, but no data are available, last observation carried forward (LOFC) is used to impute the missing data. A non-surviving participant receives a score of 4 (worst score) for the day of death and every day thereafter.||units on a scale||Standard Deviation|Mean
756851|NCT00604214|Secondary|Average Cardiovascular Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28|Scores range from 0 (normal) to 4 (organ failure) with an increasing score indicating increasing cardiovascular dysfunction. A non-surviving participant receives a score of 4 (worst score) for the day of death and every day thereafter.|Day 1 through Day 28|All randomized participants with any post-baseline data on Day 1 through Day 28. For those days when a participant is alive, but no data are available, last observation carried forward (LOFC) is used to impute the missing data. A non-surviving participant receives a score of 4 (worst score) for the day of death and every day thereafter.||units on a scale||Standard Deviation|Mean
756852|NCT00604214|Secondary|28-Day All-Cause Mortality in Participants With Severe Protein C Deficiency|Expressed as percentage of participants who died from any cause at Day 28 endpoint. Participants with severe protein C deficiency are those who had a protein C level ≤ half the lower limit of normal (LLN) (≤40%).|Day 28|All randomized participants with severe protein C deficiency at Baseline with known mortality status at Day 28.||percentage of participants|||Number
756853|NCT00604214|Primary|28-Day All-Cause Mortality|Expressed as percentage of participants who died from any cause at Day 28 endpoint.|Day 28|All randomized participants with known mortality status at Day 28.||percentage of participants|||Number
756854|NCT00604279|Secondary|Percentage of Participants Who Responded to PANSS Total Score at Day 92 or Early Withdrawal|A responder is defined as a participant who improved from baseline in the PANSS total score by 30 percent or more.|Day 92 or early withdrawal|Per Protocol Analysis Set.||Percentage of participants|||Number
756855|NCT00604279|Secondary|Change From Baseline in the Sleep Visual Analog Scale (VAS) Score at Day 92 or Early Withdrawal|The self-administered sleep VAS scale (0-100 millimeter [mm]) rates quality of sleep (QoS) and daytime drowsiness (DD). Participants indicate mark on the scale to represent how well they have slept in the previous 7 days, score ranges from 0 mm (very badly) to 100 mm (very well); and how often they have felt drowsy within the previous 7 days, from 0 mm (not at all) to 100 mm (all the time).|Baseline, Day 92 or early withdrawal|Per Protocol Analysis Set.||millimeter (mm)||Standard Deviation|Mean
756856|NCT00604279|Secondary|Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Day 92 or Early Withdrawal|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher change scores indicate worsening."|Baseline, Day 92 or early withdrawal|"Per Protocol Analysis Set. Here N (Number of Participants Analyzed) represents number of participants who were evaluable for this measure."||Units on scale||Standard Deviation|Mean
756857|NCT00604279|Secondary|Change From Baseline in Personal and Social Performance (PSP) Score at Day 92 or Early Withdrawal|This PSP assesses the degree of a participant’s dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (1, absent to 4, very severe) in each of the 4 domains. Based on the four domains there will be one total score. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; <= 30, functioning so poorly as to require intensive supervision.|Baseline, Day 92 or early withdrawal|"Per Protocol Analysis Set. Here N (Number of Participants Analyzed) represents number of participants who were evaluable for this measure."||Units on scale||Standard Deviation|Mean
756858|NCT00604279|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 92 or Early Withdrawal|The PANSS provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 (absent) to 210 (extreme psychopathology). Higher change scores indicate worsening.|Baseline, Day 92 or early withdrawal|Per Protocol Analysis Set included participants who received at least 2 injections of study medication had minimum 5 weeks of exposure to study treatment; had baseline and at least 1 post randomization measurement for primary efficacy variable and who did not have major protocol violations.||Units on scale||Standard Deviation|Mean
756859|NCT00604383|Secondary|Change From Baseline up to 36 Months in Mental and Physical Components of the Medical Outcomes Study 36-Item Short Form (SF-36) Health Status Questionnaire|SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions. There are 2 component scores, mental component score (MCS) and physical component score (PCS). MCS score consisted of social functioning, vitality, mental health, and role-emotional scales. PCS score consisted of physical functioning, bodily pain, role-physical, and general health scales. Both MCS and PCS have scores ranging from 0 to 100 with higher scores indicating better mental or physical health.|Baseline, up to 36 months|All randomized participants with evaluable SF-36 MCS and PCS. LOCF was used to impute missing post-baseline values||units on a scale||Standard Deviation|Mean
756860|NCT00604383|Secondary|Change From Baseline up to 36 Months in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25)|NEI-VFQ-25 consisted of 25 questions and was used to measure the influence of visual disability and symptoms on general health of participants. The possible total score range for the NEI-VFQ-25 was from 0 (worst possible outcome) to 100 (best possible outcome).|Baseline, up to 36 months|All randomized participants with evaluable NEI-VFQ-25 total score. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.||units on a scale||Standard Deviation|Mean
756861|NCT00604383|Secondary|Percentage of Participants Who Experienced the Development of Proliferative Diabetic Retinopathy (PDR)|Percentage of participants = (number of participants who experienced the development of PDR) / (number of participants who were randomized) * 100.|Baseline through 36 months|All randomized participants.||percentage of participants|||Number
756862|NCT00604383|Secondary|Percentage of Participants Who Developed Center Involved or Imminently Threatened Diabetic Macular Edema (DME)|DME is the accumulation of extracellular fluid in the retinal tissue of the macular area, which can reduce the ability for fine visual discrimination. Percentage of participants = (number of participants who developed center involved or imminently threatened DME) / (number of participants who had no center involved or imminently threatened DME at baseline) * 100.|Baseline through 36 months|All randomized participants who had no center involved or imminently threatened DME at baseline.||percentage of participants|||Number
756863|NCT00604383|Primary|Percentage of Participants Who Had Sustained Moderate Visual Loss (SMVL) as Defined as a Visual Acuity Loss of ≥15 Letters Measured Twice During a 6-month Period|SMVL is defined as a ≥15-letter decrease from baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) that the participant sustained during the last 6 months of study participation (Months 30-36). Participants who discontinued the study early may have had SMVL if there was a 6-month period of ≥15 letters lost in VA ending with the last visit at which VA was assessed. ETDRS visual acuity uses an eye chart with 5 letters per line. The scores range from 0 (no letters read correctly) to 100 (all letters read correctly). Percentage of participants = (number of participants who had SMVL) / (number of participants who were randomized) * 100.|Baseline through 36 months|All randomized participants.||percentage of participants|||Number
756864|NCT00604461|Secondary|Number of Months of Progression Free Survival (PFS)|The PFS is defined as the duration of time from the start of treatment to time of progression or death, whichever occurs first.|2 Years, 9 Months|All participants||Months||95% Confidence Interval|Median
756865|NCT00604461|Primary|Number of Participants With Partial Response (PR) of Target Lesions|Tumor response was assessed in 12 patients who had at least one follow-up computed tomography (CT) scan. Response Evaluation Criteria in Solid Tumors (RECIST) definition of Partial Response: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.|Up to 12 Months|All participants with baseline and at least one post-baseline target lesion measurement.||participants|||Number
756866|NCT00604500|Primary|End of Use Agreement: Number of Inhalers With an End of Use Agreement of 0 (Completer Population)|The difference in the final MDI dose counter readout and the total number of recorded actuations at the end-of-use. Dose Counter end-of-use agreement was calculated as the sum of the absolute difference between the final dose counter readout and the number of recorded actuations across all participants who used at least 90% of the labeled actuations (excluding participants who used the inhaler beyond the labeled number of actuations) divided by the total number of participants in this population. No participant used more than two inhalers during the treatment period.|4-week Treatment Period|Completer Population, excluding 2 participants who used more than the labeled number of actuations.||Number of inhalers|||Number
756867|NCT00604500|Primary|Overall Discrepancy Size|Discrepancy Size refers to the magnitude of the discrepancy between the dose counter readout and the number of recorded actuations (definition of discrepancy). Overall Discrepancy Size was calculated as 100 multiplied by the sum of the absolute values from each Dose Counter Discrepancy Size across all participants who used at least 90% of the labeled actuations divided by the total number of recorded actuations in the same participant population.|4-week Treatment Period|Completer Population, defined as participants who had recorded use of at least 90% of the labeled actuations during the 4-week Treatment Period.||Discrepancy Size Per 100 actuations|||Number
756868|NCT00604500|Primary|Overall Quartile Discrepancy Rate|"Quartile discrepancies refer to the difference between
the participant-recorded number of actuations and the participant-recorded
counter readout at each of the 4 weekly visit intervals [ie, quartiles] to
evaluate whether there was any difference in agreement over the life of
the inhaler. The Quartile Discrepancy Rate was calculated as 100 multiplied by the total number of discrepancies per Quartile across all participant who used at least 90% of the labeled actuations divided by the total number of actuations per Quartile in the same population."|4-week Treatment Period|Completer Population, defined as participants who had recorded use of at least 90% of the labeled actuations during the 4-week Treatment Period.||discrepancies per 100 actuations|||Number
756869|NCT00604500|Primary|Overall Discrepancy Rate|Overall discrepancies refer to the difference between the participant-recorded number of actuations and the participant-recorded dose counter readout across the 4-week Treatment Period. The Overall Discrepancy Rate was calculated as 100 multiplied by the total number of discrepancies across all participants who used at least 90% of the labeled actuations divided by the total number of actuations in the same participant population (Completer Population).|4-week Treatment Period|Completer population, defined as participants who recorded use of at least 90% of the labeled actuations during the 4-week Treatment Period.||Overall discrepancies per 100 actuations|||Number
756870|NCT00604552|Secondary|Evaluate the Occurrence of Endoleak, Stent Graft Migration, Aneurysm Enlargement, Device Integrity and Adverse Events.||5 years||||||
756871|NCT00604552|Primary|Evaluate the Occurrence of Death, Aneurysm Rupture, and Surgical Conversion|Number of patients that had an occurrence of death, aneurysm rupture or surgical conversion|5 year|All those treated on-label for the treatment of an AAA and followed out to 5 years.||participants|||Number
756872|NCT00604565|Primary|TOTAL NUMBER OF ADVERSE EVENTS|Incidence and seriousness of adverse events will be captured from date of randomization until study participation completion (up to 36 weeks). For the Primary Outcome Measure, total number of events are listed only. The details of the types of events that took place are reported in the Adverse Events section.|36 weeks|All subjects were included in the Safety Analysis population.||events|||Number
756873|NCT00604565|Primary|TOTAL NUMBER OF SUBJECTS WITH ADVERSE EVENTS|Incidence and seriousness of adverse events will be captured from date of randomization until study participation completion (up to 36 weeks). For the Primary Outcome Measure, total number of subjects affected are listed only. The details of the types of events that took place are reported in the Adverse Events section.|36 weeks|All subjects were included in the Safety Analysis population.||participants|||Number
756874|NCT00604669|Primary|Mortality|Mortality rate of those with hyperglycemia while on TPN duing the period of 1/01/06 to 12/31/06.|at the end of the chart review of all patients|||mortality rate|||Number
756875|NCT00604695|Secondary|Safety Endpoint: Number of Deaths||Through 30days following primary percutaneous coronary intervention|Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo)||participants|||Number
786173|NCT00833690|Secondary|Change in Serum Urate|Change from an Average of Baseline and Screening Visits|Visit 05 from Baseline (i.e., between -45 days and +12 weeks)|||mg/dL||Standard Deviation|Mean
756879|NCT00604695|Secondary|Number of Patients With Hyperemic Flow in the Culprit Artery. That is Corrected Thrombolysis In Myocardial Infarction (TIMI) Frame Count (cTFC) of Less Than 14|Corrected Thrombolysis In Myocardial Infarction (TIMI) Frame Count (cTFC) of less than 14|Following Primary Percutaneous Coronary Intervention Prior to Second Bolus of the Study Drug|Of the 20 patients in treatment arm, 4 did not meet the inclusion criteria of TIMI Flow Grade(TFG) 0/1 and cTFC could not be obtained in 4 patients Of the 20 patients in placebo arm, 4 did not receive the first bolus (drug or placebo) and 3 patients did not meet the inclusion criteria of TFG 0/1. cTFC could not be obtained in 3 patients||participants|||Number
756880|NCT00604695|Secondary|Measurements of Flow Velocity in the Culprit Artery in Terms of Corrected Thrombolysis In Myocardial Infarction (TIMI) Frame Count (cTFC)|Corrected Thrombolysis In Myocardial Infarction (TIMI) Frame Count (cTFC) in the culprit artery|Following Primary Percutaneous Coronary Intervention Prior to Second Bolus of the Study Drug|Of the 20 patients in treatment arm, 4 did not meet the inclusion criteria of TIMI Flow Grade(TFG) 0/1 and cTFC could not be obtained in 4 patients Of the 20 patients in placebo arm, 4 did not receive the first bolus (drug or placebo) and 3 patients did not meet the inclusion criteria of TFG 0/1. cTFC could not be obtained in 3 patients||Corrected TIMI Frame Count (cTFC)||Inter-Quartile Range|Median
756881|NCT00604695|Secondary|Number of Patients With Thrombolysis In Myocardial Infarction (TIMI) Myocardial Perfusion Grade (TMPG) of 2 or 3 in the Territory of the Culprit Artery Following Primary Percutaneous Coronary Intervention Prior to Second Bolus of the Study Drug|Thrombolysis In Myocardial Infarction (TIMI) Myocardial Perfusion Grade (TMPG) of 2 or 3 in the territory of the culprit artery|Following Primary Percutaneous Coronary Intervention Prior to Second Bolus of the Study Drug|"Of the 20 patients randomized to the treatment arm, 4 patients did not meet the inclusion criteria of Thrombolysis In Myocardial Infarction (TIMI) Flow Grade(TFG) 0/1.
Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo) and 3 patients did not meet the inclusion criteria of TFG 0/1."||participants|||Number
756882|NCT00604695|Secondary|Number of Patients With Decrease in Thrombus Grade in the Culprit Artery Following the First Bolus of Study Drug Prior to Primary Percutaneous Coronary Intervention||Following the First Bolus of Study Drug Prior to Primary Percutaneous Coronary Intervention|"Of the 20 patients randomized to the treatment arm, 4 patients did not meet the inclusion criteria of Thrombolysis In Myocardial Infarction (TIMI) Flow Grade(TFG) 0/1.
Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo) and 3 patients did not meet the inclusion criteria of TFG 0/1."||participants|||Number
756883|NCT00604695|Primary|Percent Diameter Stenosis of the Culprit Lesion Following the First Bolus of Study Drug Prior to Primary Percutaneous Coronary Intervention||Following the First Bolus of Study Drug Prior to Primary Percutaneous Coronary Intervention|"Of the 20 patients randomized to the treatment arm, 4 patients did not meet the inclusion criteria of Thrombolysis In Myocardial Infarction (TIMI) Flow Grade(TFG) 0/1.
Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo) and 3 patients did not meet the inclusion criteria of TFG 0/1."||Percent diameter stenosis||Inter-Quartile Range|Median
756884|NCT00604708|Primary|GMT (Geometric Mean Titer) of IC51 Compared to JE-VAX at Day 56|GMT: geometric mean of PRNT50|Day 56|PP Population: All randomized subjects without any major protocol deviations as assessed during a Data Review Meeting. Subjects who were randomized incorrectly or took the wrong study medications were also excluded.||titers||Standard Deviation|Geometric Mean
756885|NCT00604708|Secondary|Immunogenicity at Day 56 for Subjects Older vs. Younger Than 50 Years of Age||Day 56||||||
756886|NCT00604708|Secondary|Immunogenicity at Day 56 for North America vs. Europe||Day 56||||||
756887|NCT00604708|Secondary|Immunogenicity at Day 28||Day 28||||||
756888|NCT00604708|Secondary|Safety and Adverse Events||until Day 56||||||
756889|NCT00604708|Primary|SCR (Seroconversion Rate)of IC51 Compared to JE-VAX at Day 56|SCR: anti-JEV neutralizing antibody titer ≥1:10|Day 56|Per Protocol Population: all randomized subjects without any protocol deviations as defined in the Statistical Analysis Plan||percentage of participants|||Number
756890|NCT00604721|Secondary|Median Overall Survival (OS)|Overall survival has been defined as time from the start of treatment to death as a result of any cause.|33 weeks|Participants who completed a full 21 day cycle of therapy||months||95% Confidence Interval|Median
756891|NCT00604721|Secondary|Median Progression Free Survival (PFS)|Progression free survival has been defined as time from the start of treatment to disease progression or death as a result of any cause.|33 weeks|Participants who completed a full 21 day cycle of therapy||months||95% Confidence Interval|Median
756892|NCT00604721|Primary|Number of Participants With Radiographic Objective Response (OR)|"To ascertain the objective response rate (Complete Response + Partial Response [CR+PR]) of patients with the single-agent AZD6244. Our study utilized Response Evaluation Criteria in Solid Tumors (RECIST) to evaluate response.
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters."|33 weeks|Participants who completed a full 21 day cycle of therapy||participants|||Number
756893|NCT00604786|Primary|Change in Basophil Surface IgE|"Flow cytometry in mean fluorescence units.
100%*[(3.5 month value minus baseline value)/baseline value]"|Change from baseline to 3.5 months|2 participants on the Omalizumab subcutaneous group moved and were therefore lost to follow-up.||percentage of basophil surface IgE||Standard Deviation|Mean
756894|NCT00604812|Secondary|Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan – Apparent Half-life (Apparent t½)|Preliminary pharmacokinetics data; Apparent half-life (t½)|24 Hours|Per Protocol-The set of data generated by the subset of subjects who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers exposure to treatment, availability of measurements and absence of major protocol violations.||Hours||Standard Deviation|Mean
756931|NCT00604825|Primary|Change From Baseline and Week 12 in Inflammatory Marker- Endothelin-1 at Week 12|Inflammatory marker included Endothelin-1. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 12|Safety Population. Only those participants available at the specified time points were analyzed.||Nanogram per Liter||Standard Deviation|Mean
756895|NCT00604812|Secondary|Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan – Time to Maximum Concentration (Tmax)|Preliminary pharmacokinetics data; Time to maximum concentration (Tmax); i.e., amount of time required to reach maximum concentration|24 Hours|Per Protocol-The set of data generated by the subset of subjects who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers exposure to treatment, availability of measurements and absence of major protocol violations.||Hours||Full Range|Median
756896|NCT00604812|Secondary|Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan – Maximum Concentration (Cmax)|Preliminary pharmacokinetics data; Maximum concentration (Cmax); i.e, highest concentration of drug achieved|24 Hours|Per Protocol-The set of data generated by the subset of subjects who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers exposure to treatment, availability of measurements and absence of major protocol violations.||ng/mL||Standard Deviation|Mean
756897|NCT00604812|Secondary|Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan- Area Under the Curve (AUC(0-∞))|Preliminary pharmacokinetics data; Area Under the Curve (AUC(0-∞)); i.e., area under the concentration-time plot|24 Hours|Per Protocol-The set of data generated by the subset of subjects who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers exposure to treatment, availability of measurements and absence of major protocol violations.||ng hr/mL||Standard Deviation|Mean
756898|NCT00604812|Primary|Safety and Tolerability of Single Doses of Rizatriptan in Pediatric Migraineurs|All adverse experiences spontaneously reported by subject and/or observed by investigator and repeated clinical evaluation of physical examinations, vital signs, 12-lead ECG (electrocardiogram) and laboratory safety tests (hematology/blood chemistry/urinalysis)|24 Hours|All Subjects as Treated- All subjects who received at least one dose of the investigational drug was used for assessments of safety and tolerability.||Participants|||Number
756899|NCT00604825|Secondary|Change From Baseline at Week 12 in Abdomen Visceral Adipose Tissue (AVAT), Abdomen Subcutaneous Adipose Tissue (ASAT), Thigh Subcutaneous Adipose Tissue (TSAT) and Thigh Intermuscular Adipose Tissue (TIAT)|AVAT, ASAT, TSAT and TIAT was measured in centimeter to once decimal place by CT scan. A CT scan of the abdomen was conducted at the Lumbar 4 vertebrae level. A CT scan of the right thigh was performed at half the distance between the knee joint and greater trochanter femoralis. Scans were performed with 120 kilovolts, 5 millimeter slice thickness (thigh scan 3 millimeter slice thickness) and 48 centimeter scan field of view. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 12|Body Composition Population. Only those participants available at the specified time points were analyzed.||Square centimeters||Standard Deviation|Mean
756900|NCT00604825|Secondary|Change From Baseline at Week 12 in Abdomen Body Circumference, Abdomen Saggital Diameter and Thigh Circumference|Thigh circumference was measured on the left leg directly below the gluteal fold; with the participant standing with both arms at the side, feet together, and with equal weight on both feet when this measurement was taken. The thigh was measured at least twice until two measurements were within 1 centimeter, and the last reading recorded. Abdomen body circumference and abdomen saggital diameter was measured in centimeter to once decimal place by Computerized tomography (CT) scan with the participant in supine position. CT scan of the abdomen was conducted at the Lumbar 4 vertebrae level. Scans were performed with 120 kilovolts, 5 millimeter slice thickness and 48 centimeter scan field of view. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 12|Body Composition Population which comprised of any ITT participants who provided consent for the body composition sub-study and received additional body composition assessments. Only those participants available at the specified time points were analyzed.||Centimeters||Standard Deviation|Mean
756901|NCT00604825|Secondary|Change From Baseline at Week 12 in Body Mass Index (BMI)|BMI was calculated from height (taken at Screening Visit 1 [Day -35]) and weight at Week 12 using the formula: BMI = [weight in kilograms divided by (height in meters)^2]. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 12|ITT Population. Only those participants available at the specified time points were analyzed.||Kilogram per square meters||Standard Error|Least Squares Mean
756902|NCT00604825|Secondary|Change From Baseline at Week 12 in Weight|Participants were weighed on a calibrated balance beam or digital scale. Participants were instructed to be dressed in light indoor clothing without shoes and also to have empty pockets and to void before weighing. It was strongly recommended that participants were weighed in the morning at the beginning of the clinic visit. Weight was measured at least twice or more if necessary, until two measurements were within 0.5 kilograms. The last (confirmed) reading was recorded in the electronic case report form. Weight was recorded in kilograms to the nearest tenth. When the weight was measured in pounds, it was converted into kilograms using the conversion factor: pounds/ 2.2 = kilograms. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 12|ITT Population. Only those participants available at the specified time points were analyzed.||Kilograms||Standard Error|Least Squares Mean
756903|NCT00604825|Secondary|Change From Baseline at Week 12 in Hip Circumference|For hip circumference, the participant was instructed to stand erect with arms at sides and feet together. The measurement was taken at the point yielding the maximum circumference over the buttocks (widest part of the greater trochanters) with nonstretchable tape. The tape was even, not twisted with the measurement scale facing outward. The assessor was instructed to ensure that the tape was just touching the skin but not compressing the soft tissue. The hip should be measured at least twice until two measurements are within 1 centimeter and the last reading recorded. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 12|ITT Population. Only those participants available at the specified time points were analyzed.||Centimeters||Standard Error|Least Squares Mean
756932|NCT00604825|Primary|Change From Baseline and Week 12 in Inflammatory Marker- High Sensitivity C-reactive Protein (Hs-CRP) at Week 12|Inflammatory marker included hs-CRP. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 12|Safety Population. Only those participants available at the specified time points were analyzed.||Milligram per Liter||Standard Deviation|Mean
756904|NCT00604825|Secondary|Change From Baseline at Week 12 in Waist Circumference|To measure waist circumference, clothing was lifted from around the waist to ensure correct positioning of the measuring tape. Participants were instructed to stand erect with abdomen relaxed, arms at side, feet together, and weight equally divided over both legs. The non-stretchable tape was placed at the waist midway between the palpated iliac crest and the palpated lowest rib margin in the left and right mid-axillary lines. The tape was even, parallel to the floor not twisted with the measurement scale facing outward. The assessor was instructed to ensure that the tape was just touching the skin but not compressing the soft tissue. The measurement was made at the end of a normal expiration. The waist was measured at least twice or more if necessary, until two measurements were within 1 centimeter and the confirmatory reading recorded to one decimal place. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 12|ITT Population. Only those participants available at the specified time points were analyzed.||Centimeters||Standard Error|Least Squares Mean
756905|NCT00604825|Secondary|Change From Baseline at Week 12 in Serum Hormone Levels- Testosterone|Serum hormones included testosterone. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. Mean change from Baseline at Week 12 in testosterone are presented.|Baseline (Week 0) and Week 12|Safety Population. Only those participants available at the specified time points were analyzed.||Nanomol per Liter||Standard Deviation|Mean
756906|NCT00604825|Secondary|Change From Baseline at Week 12 in Serum Hormone Levels- Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH)|Serum hormones included FSH and LH. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 12|Safety Population. Only those participants available at the specified time points were analyzed.||International units per Liter||Standard Deviation|Mean
756907|NCT00604825|Secondary|Change From Baseline at Week 12 in Serum Hormone Levels- Estradiol|Serum hormone included Estradiol. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. Mean change from Baseline at Week 12 in estradiol are presented.|Baseline (Week 0) and Week 12|Safety Population. Only those participants available at the specified time points were analyzed.||Picomoles per Liter||Standard Deviation|Mean
756908|NCT00604825|Secondary|Change From Baseline in Glucose at Week 12|Pharmacodynamic marker included glucose. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 12|ITT Population. Only those participants available at the specified time points were analyzed.||Millimoles per Liter||Standard Deviation|Mean
756909|NCT00604825|Secondary|Change From Visit 2 to Visit 8 in Percentage of Superficial Cells to Determine the Vaginal Maturation Index (VMI)|"A lateral vaginal wall specimen was collected at Visit 2 (Day -21) and Visit 8 (Week 12) and was sent to Central Pathology for analysis. Parabasal, intermediate, and superficial squamous cells were counted and percentages calculated. The VMI (also referred to as Maturation Value [MV]) of the vaginal mucosa was calculated according to the following equation:
VMI (MV)= (% Intermediate Cells x 0.5) + (% Superficial cells). Visit 2 was Day -21 and Visit 8 was Week 12. Change from Visit 2 to Visit 8 was calculated by subtracting Visit 2 values from Visit 8 values."|Visit 2 (Day -21) to Visit 8 (Week 12)|ITT Population. Only those participants available at the specified time points were analyzed.||Percentage of cells||Standard Error|Least Squares Mean
756910|NCT00604825|Secondary|Change From Visit 2 to Visit 8 in Vaginal pH|Vaginal pH was measured at Visit 2 and Visit 8 using standard pH indicator strips available at the participating site clinic. The pH indicator strip was inserted to the upper portion of the proximal one third of the vaginal vault, placed in contact with the lateral vaginal mucosal wall for approximately 1 minute, and evaluated according to the instructions provided in the package labeling. pH is calculated on a scale of 0 to 14, such that, the lower the number, more acidic the vagina and higher the number, more alkaline the vagina with 7 being neutral. Change from Visit 2 to Visit 8 was calculated by subtracting Visit 2 values from Visit 8 values.|Visit 2 (Day -21) to Visit 8 (Week 12)|ITT Population. Only those participants available at the specified time points were analyzed.||Points on a scale||Standard Error|Least Squares Mean
756911|NCT00604825|Secondary|Change in Work Productivity and Activity Impairment (WPAI) Score From Visit 2 to Visit 7|The WPAI is a questionnaire that measured workplace productivity and absenteeism via 6 items/questions, adapted to participants experiencing menopausal symptoms. Item 1 asks about current employment with a yes/no response. Items 2– 4 ask for continuous response in hours. Item 5 asks for response on rating scale related to WP ranging from 0:Menopausal symptoms had no effect on work to 10:Couldn’t work at all. Item 6 asks for response on rating scale related to daily activities ranging from 0:no effect on daily activities to 10:Couldn’t perform any daily activities. The score calculation- Effect on work: (Item 5 score÷10); Absenteeism: (Item 2÷Item 2+Item 4); Overall work impairment ([Item 2÷Item 2+Item 4]+ [1- {Item 2÷Item 2+Item 4}]*[ Item 5 score÷10]); Activity impairment: (Item 6 score÷10). Total score range from 0 to 10 where higher score indicates worst condition. Visit 2 was Day -21. Change from Visit 2 was calculated by subtracting Visit 2 values from post-Visit 2 values.|Visit 2 (Day -21) to Visit 7 (Week 8)|ITT Population. Only those participants available at the specified time points were analyzed.||Scores on a Scale||Standard Error|Least Squares Mean
756912|NCT00604825|Secondary|Change in the Centers for Epidemiologic Studies in Depression (CES-D) Score From Visit 2 to Visit 7|The CES-D is a questionnaire designed to measure depressive symptoms via 20 items that are summed to create a total score. Depressive symptoms are fairly common in postmenopausal women, and it’s possible that stimulation of estrogen receptors via a selective estrogen receptor modulator may improve depressive symptoms. Questions 4, 8, 12 and 16 are weighted negatively (the scores are flipped prior to creating total score). If 3 or more items are missing then total score is missing. If fewer than 3 items are missing then missing item is set to group mean of that item for appropriate randomized treatment group. These means are only calculated if more than half of the participants used for calculation have responded to item. The items are summed to give total score ranging from 0 to 60. Lower score 0=no depression, higher score 60=higher degree of depression severity. Visit 2 was Day -21. Change from Visit 2 was calculated by subtracting Visit 2 values from post-Visit 2 values.|Visit 2 (Day -21) to Visit 7 (Week 8)|ITT Population. Only those participants available at the specified time points were analyzed.||Scores on a Scale||Standard Error|Least Squares Mean
757004|NCT00605280|Secondary|Number of Participants With a ≥ 15 Letter Improvement in Vision at 2 Years|Refraction and best-corrected VA measurements were performed using retro-illuminated, modified Ferris-Bailey ETDRS charts|Baseline, Year 2|FAS2 population. LOCF.||Participants|||Number
756913|NCT00604825|Secondary|Change in Brief Fatigue Inventory (BFI) Score From Visit 2 to Visit 7|The BFI is a validated questionnaire designed to measure a participant’s fatigue via nine questions that are summated to create a total score. Items 1-3 request a rating on a scale ranging from 0 – 10 with 0 representing ‘No Fatigue’ and 10 representing ‘As bad as you can imagine’. Five items 4A-4F request an interference score on a scale ranging from 0 – 10 with 0 representing ‘Does not interfere’ and 10 representing ‘Completely Interferes’. The values of the scales for all items was used in scoring the response to each item. The following groupings of items was used to create domain scores. The total score is calculated by taking the sum of all 9 rating scales for a minimum score of 0 and a maximum score of 90. Higher score indicates more severe fatigue. Visit 2 was Day -21. Change from Visit 2 was calculated by subtracting Visit 2 values from post-Visit 2 values.|Visit 2 (Day -21) to Visit 7 (Week 8)|ITT Population. Only those participants available at the specified time points were analyzed.||Scores on a Scale||Standard Error|Least Squares Mean
756914|NCT00604825|Secondary|Changes in Vulvar Vaginal Atrophy (VVA) Symptom Score From Baseline to Visit 8 (Week 12)|The VVA Symptoms Scale questionnaire is an 18-item instrument that captures symptoms related to VVA, asks participant to identify symptom that bothers them the most and contains items to assess degree of bother participants experience from each symptom and impact that most bothersome symptom has on their daily life. Items 1 to 8 had responses and scores of none=0, mild=1, moderate=2 and severe=3. Items 9 to 18 had responses and scores of not at all=0, a little=1, moderately=2 and a lot=3. Severity item and bothersome item respectively were as follows: vaginal dryness:1 and 9; Vaginal itching:2 and 10; Vaginal irritation:3 and 11; Painful urination:4 and 12; Difficulty urinating:5 and 13; Vaginal pain associated with sexual activity:6 and 14; Vaginal bleeding associated with sexual activity:7 and 15. Total score ranged from 0 to 3; higher score indicated most bothersome. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) to Visit 8 (Week 12)|ITT Population. Only those participants available at the specified time points were analyzed.||Scores on a Scale||Standard Deviation|Mean
756915|NCT00604825|Secondary|Change in Medical Outcomes Study (MOS) Sleep Score From Baseline to Visits 6 (Week 4) and Visit 8 (Week 12)|The MOS Sleep Scale is a validated questionnaire designed to measure a participant sleep quality via 12 questions. Items are designed to be grouped into domains that include sleep disturbance (items 1, 3, 7, 8), sleep adequacy (items 4, 12), daytime somnolence (items 6, 9, 11), sleep quantity (2), 6-Item Sleep Scale (items 4, 5, 7, 8, 9, 12) and 9-Item Sleep Scale (items 3, 4, 5, 6, 7, 8, 9, 11, 12). Each domain is given a separate score. The domain score is calculated as the sum of the individual item scores in that domain. Transformed scores were calculated for the domains only. This transformation converts the raw domain score to a 0 to 100 scale following the formula: Transformed score = ([Raw score – Lowest possible score]/Possible score range)*100. Lowest score 0 indicates best sleep quality and higher score 100 indicates worst sleep quality. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) to Week 12|ITT Population. Only those participants available at the specified time points were analyzed.||Scores on a Scale||Standard Error|Least Squares Mean
756916|NCT00604825|Secondary|Change in Menopause Quality of Life (MENQoL) Score From Baseline to Visits 6 (Week 4) and Visit 8 (Week 12)|MENQOL instrument is a 32-item, validated questionnaire designed to measure symptoms that participants experience due to menopause and degree to which these symptoms bother them. Each item references a symptom and is composed of two-part question; a yes/no confirmation that the participant has symptom followed by a question asking how bothersome the symptom is, if present. The MENQOL items are designed to be grouped into domains that address vasomotor (items 1-3), psychosocial(items 4-10), physical (items 11-26, 30-32) and sexual symptoms (items 27-29). Each domain is given a separate score; there is no overall score. The domain score is sum of individual item scores divided by number of items in that domain. Since domain subscales are not comprised of an equivalent number of items, mean of subscale is used as overall subscale score. Each domain score ranges from 1 to 8. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) to Week 12|ITT Population. Only those participants available at the specified time points were analyzed.||Scores on a Scale||Standard Error|Least Squares Mean
756917|NCT00604825|Secondary|Number of Participants With VMS Percent Change From Baseline Responders With a Reduction in Severity at Week 12 of at Least 50%, at Least 75%, and 100%|Individual VMS (hot flash or night sweats) events were recorded by participants in an eDiary using global change questions. The VMS severity was as follows: mild (brief wave of heat with minimal discomfort, usually without perspiration; able to continue activity [or sleep]), moderate (heat with some discomfort, usually with perspiration; minimal interruption of activity [or sleep]), severe (intense heat with considerable discomfort, usually with heavy sweating; may be unable to resume activity [or sleep] right away) and extremely severe (unbearable heat with intense discomfort, usually with pouring sweat; may be unable to resume activity [or sleep] for quite a while). The severity of VMS events were calculated using self-reported participants assessments recorded and transmitted by eDiary. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. Percent change was calculated by multiplying change from Baseline value with 100.|Baseline (Week 0) and Week 12|ITT Population with LOCF analysis. Only those participants available at the specified time points were analyzed.||Participants|||Count of Participants
756918|NCT00604825|Secondary|Number of Participants With VMS Percent Change From Baseline Responders With a Reduction in Frequency at Week 12 of at Least 50%, at Least 75%, and 100%|Individual VMS (hot flash or night sweats) events were recorded by participants in an eDiary using global change question. The severity of VMS events were calculated using self-reported participants assessments recorded and transmitted by eDiary. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. Percent change was calculated by multiplying the change from baseline value with 100. Number of participants with VMS percent change from Baseline responders with a reduction in frequency at Week 12 of at least 50%, at least 75%, and 100% are presented.|Baseline (Week 0) and Week 12|ITT Population with LOCF analysis. Only those participants available at the specified time points were analyzed.||Participants|||Count of Participants
756933|NCT00604825|Primary|Change From Baseline in Thrombotic Marker- Tissue Plasminogen Activator (tPA) Antigen at Week 12|Thrombotic marker included tPA antigen. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 12|Safety Population. Only those participants available at the specified time points were analyzed.||Microgram per Liter||Standard Deviation|Mean
756919|NCT00604825|Secondary|Mean Change in Severity of VMS From Baseline to Weeks 4 and 8|Individual VMS (hot flash or night sweats) events were recorded by participants in an eDiary using global change questions. The VMS severity was as follows: mild=score of 1 (brief wave of heat with minimal discomfort, usually without perspiration; able to continue activity [or sleep]), moderate=score of 2(heat with some discomfort, usually with perspiration; minimal interruption of activity [or sleep]), severe=score of 3(intense heat with considerable discomfort, usually with heavy sweating; may be unable to resume activity [or sleep] right away) and extremely severe=score of 4 (unbearable heat with intense discomfort, usually with pouring sweat; may be unable to resume activity [or sleep] for quite a while). Total score ranged from 1 to 4 and is the sum of severity scores divided by total number of VMS events. Higher score indicates worst condition. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) to Week 8|ITT Population with LOCF analysis. Only those participants available at the specified time points were analyzed.||Scores on a Scale||Standard Error|Least Squares Mean
756920|NCT00604825|Secondary|Mean Change in Frequency of VMS From Baseline to Weeks 4 and 8|"Individual VMS (hot flash or night sweats) events were recorded by participants in an eDiary using as Global Change Question. The frequency was assessed using the question 1 as Since you started the study medication, how has the number of your hot flashes (including night sweats) changed?. the response was rated on a 7-point scale from +3 to -3, where +3=A great deal better, +2=Moderately better, +1=A little better, 0=No change, -1=A little worse, -2=Moderately worse and -3=A great deal worse. The score ranged from +3 to -3, where +3 implied absence of symptoms and lower score implied more severe symptoms. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values."|Baseline (Week 0) to Week 8|ITT Population with LOCF analysis. Only those participants available at the specified time points were analyzed.||Scores on a Scale||Standard Error|Least Squares Mean
756921|NCT00604825|Primary|Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (C02) Content, Chloride, Phosphorous, Inorganic, Potassium, Sodium and Urea at Week 12|Clinical chemistry parameters included calcium, C02 content, chloride, phosphorous, inorganic, potassium, sodium and urea. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 12|Safety Population. Only those participants available at the specified time points were analyzed.||Millimol per Liter||Standard Deviation|Mean
756922|NCT00604825|Primary|Change From Baseline in Clinical Chemistry Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST) at Week 12|Clinical chemistry parameters included ALT, ALP and AST. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 12|Safety Population. Only those participants available at the specified time points were analyzed.||Units per Liter||Standard Deviation|Mean
756923|NCT00604825|Primary|Change From Baseline in Clinical Chemistry Parameters- Creatinine, Direct Bilirubin, Total Bilirubin and Uric Acid at Week 12|Clinical chemistry parameters included creatinine, direct bilirubin, total bilirubin and uric acid. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 12|Safety Population. Only those participants available at the specified time points were analyzed.||Micromoles per Liter||Standard Deviation|Mean
756924|NCT00604825|Primary|Change From Baseline in Clinical Chemistry Parameters- Albumin and Total Protein at Week 12|Clinical chemistry parameters included albumin and total protein. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 12|Safety Population. Only those participants available at the specified time points were analyzed.||Gram per Liter||Standard Deviation|Mean
756925|NCT00604825|Primary|Change From Baseline in Hematology Parameters- Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Segmented Neutrophils, Total Neutrophils and White Blood Cell (WBC) Count at Week 12|Hematology parameters included basophils, eosinophils, lymphocytes, monocytes, platelet count, segmented neutrophils, total neutrophils and WBC count. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. Mean change from Baseline and Week 12 in basophils, eosinophils, lymphocytes, monocytes, platelet count, segmented neutrophils, total neutrophils and WBC count are presented.|Baseline (Week 0) and Week 12|Safety Population. Only those participants available at the specified time points were analyzed.||Gigacells per Liter||Standard Deviation|Mean
756926|NCT00604825|Primary|Change From Baseline in Hematology Parameters- Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at Week 12|Hematology parameters included Hemoglobin and MCHC. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 12|Safety Population. Only those participants available at the specified time points were analyzed.||Gram per Liter||Standard Deviation|Mean
756927|NCT00604825|Primary|Change From Baseline in Hematology Parameter- Red Blood Cell (RBC) Count at Week 12|Hematology parameter included RBC count. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 12|Safety Population. Only those participants available at the specified time points were analyzed.||Trillion cells per Liter||Standard Deviation|Mean
756928|NCT00604825|Primary|Change From Baseline in Hematology Parameter- Mean Corpuscle Volume (MCV) at Week 12|Hematology parameter included MCV. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 12|Safety Population. Only those participants available at the specified time points were analyzed.||Femtoliters||Standard Deviation|Mean
756929|NCT00604825|Primary|Change From Baseline in Hematology Parameter- Mean Corpuscle Hemoglobin (MCH) at Week 12|Hematology parameter included MCH. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 12|Safety Population. Only those participants available at the specified time points were analyzed.||Picograms||Standard Deviation|Mean
756930|NCT00604825|Primary|Change From Baseline and Week 12 in Hematology Parameter- Hematocrit at Week 12|Hematology parameter included hematocrit. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 12|Safety Population. Only those participants available at the specified time points were analyzed.||Fraction||Standard Deviation|Mean
757301|NCT00607672|Secondary|Re-exploration for Bleeding|The percentage of patients that were taken back to the operating room for re-exploration because of bleeding|From arrival in intensive care unit until discharge from hospital|||percentage of patients|||Number
756935|NCT00604825|Primary|Mean Change in Severity of VMS From Baseline at Week 12|Individual VMS (hot flash or night sweats) events were recorded by participants in an eDiary using global change questions. VMS severity was as follows: mild=score of 1 (brief wave of heat with minimal discomfort, usually without perspiration; able to continue activity [or sleep]), moderate=score of 2(heat with some discomfort, usually with perspiration; minimal interruption of activity [or sleep]), severe=score of 3(intense heat with considerable discomfort, usually with heavy sweating; may be unable to resume activity [or sleep] right away) and extremely severe=score of 4 (unbearable heat with intense discomfort, usually with pouring sweat; may be unable to resume activity [or sleep] for quite a while). Total score ranged from 1 to 4 and is the sum of severity scores divided by total number of VMS events. Higher score indicates worst condition. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 12|ITT Population with LOCF analysis. Only those participants available at the specified time points were analyzed.||Scores on a Scale||Standard Error|Least Squares Mean
756936|NCT00604825|Primary|Mean Change in Frequency of Vasomotor Symptoms (VMS) From Baseline at Week 12|"Individual VMS (hot flash or night sweats) events were recorded by participants in an electronic diary (eDiary) using as Global Change Question. The frequency was assessed using the question 1 as Since you started the study medication, how has the number of your hot flashes (including night sweats) changed?. the response was rated on a 7-point scale from +3 to -3, where +3=A great deal better, +2=Moderately better, +1=A little better, 0=No change, -1=A little worse, -2=Moderately worse and -3=A great deal worse. The score ranged from +3 to -3, where +3 implied absence of symptoms and lower score implied more severe symptoms. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. Adjusted mean is presented as least square mean."|Baseline (Week 0) and Week 12|Intent-to-Treat Population (ITT) Population which comprised of all randomized participants. Last Observation Carried Forward (LOCF) was the imputation technique used.||Scores on a Scale||Standard Error|Least Squares Mean
756937|NCT00604825|Primary|Occurrence of Withdrawal Bleeding-number of Days of Spotting, Number of Days of Bleeding, Number of Days of Spotting/Bleeding Combined|After completion of the 12-week treatment period, participants with an intact uterus received a 14-day cycle of progestogen (10 mg MPA) to induce withdrawal bleeding. All participants were required to return to clinic for Follow-Up Visit. Participants were asked to record occurrence of bleeding/spotting each day, from the day MPA dosing began until Follow-up using the following criteria: None (no bleeding or spotting), Spotting: any vaginal flow requiring not more than one sanitary napkin or tampon per day (lightly stained and not soaked through) and Bleeding: any vaginal flow requiring more than one sanitary napkin or tampon per day. The following information was recorded in electronic case report form: start and stop date of MPA administration as well as dates of any spotting/bleeding. Duration of spotting, bleeding and also spotting/bleeding combined is presented.|Up to Follow-up (Day 112)|Uterine Safety Population. Only those participants available at the specified time points were analyzed.||Days||Full Range|Median
756938|NCT00604825|Primary|Occurrence of Withdrawal Bleeding-duration of Spotting/Bleeding|After completion of the 12-week treatment period, participants with an intact uterus received a 14-day cycle of progestogen (10 mg medroxyprogesterone acetate [MPA]) to induce withdrawal bleeding. All participants were required to return to clinic for Follow-Up Visit. Participants were asked to record occurrence of bleeding/spotting each day, from the day MPA dosing began until Follow-up using the following criteria: None (no bleeding or spotting), Spotting: any vaginal flow requiring not more than one sanitary napkin or tampon per day (lightly stained and not soaked through) and Bleeding: any vaginal flow requiring more than one sanitary napkin or tampon per day. The following information was recorded in electronic case report form: start and stop date of MPA administration as well as dates of any spotting/bleeding. Duration of spotting or bleeding is presented.|Up to Follow-up (Day 112)|Uterine Safety Population. Only those participants available at the specified time points were analyzed.||Days||Full Range|Median
756939|NCT00604825|Primary|Endometrial Biopsy Pathology|Endometrial biopsies were conducted at Baseline and end-of-treatment (end-of-treatment values were defined as the last available post-Baseline values before treatment was stopped) for all study participants with an intact uterus. These procedures were performed by an experienced physician. Each biopsy was obtained after the TVUS was performed. Proliferative endometrium also meant hyperplasia without atypia (normal).|Baseline (Week 0) to Week 12|Uterine safety Population. Only those participants available at the specified time points were analyzed.||Participants|||Count of Participants
756940|NCT00604825|Primary|Change From Baseline in Bi-layer Endometrial Thickness Measured by Transvaginal Ultrasound (TVUS) or Saline Infusion Sonohysterography (SIS)|All participants with an intact uterus participating in this study underwent a TVUS at Baseline and at Week 12, to investigate the cause of any abnormal uterine bleeding during the study. In the event the TVUS was not well visualized or there were abnormal findings at either visit, or the bi-layer thickness exceeded 5 millimeter at Week 12, a SIS was conducted to visualize the anterior and posterior walls. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. Mean change from Baseline and Week 12 in heart rate are presented.|Baseline (Week 0) to Week 12|Uterine Safety Population which comprised of all randomized participants who had a uterus and also received at least one dose of investigational product. Only those participants available at the specified time points were analyzed.||Millimeter||Standard Deviation|Mean
756941|NCT00604825|Primary|Change From Baseline in Fasting Lipid Profile at Week 12|Fasting lipids included total cholesterol, low density lipoprotein (LDL) cholesterol, high density lipoprotein (HDL) cholestereol direct and triglycerides. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. Mean change from Baseline in fasting lipid profile at Week 12 are presented.|Baseline (Week 0) and Week 12|Safety Population. Only those participants available at the specified time points were analyzed.||Millimole per Liter||Standard Deviation|Mean
756942|NCT00604825|Primary|Change From Baseline in Thyroxine (T4) and Insulin at Week 12|Serum hormone markers included T4 and additional pharmacodynamics marker included insulin. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. Mean change from Baseline in T4 and insulin at Week 12 are presented.|Baseline (Week 0) and Week 12|Safety Population. Only those participants available at the specified time points were analyzed.||Picomole per Liter||Standard Deviation|Mean
757302|NCT00607672|Secondary|Blood Loss|Blood loss over 24 hours as measured by chest tube output|First 24 hours after arrival in the intensive care unit|||mL||Standard Error|Mean
756943|NCT00604825|Primary|Change From Baseline in Thyroid Stimulating Hormone (TSH) at Week 12|Serum hormone markers included TSH. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. Mean change from Baseline in TSH at Week 12 are presented.|Baseline (Week 0) and Week 12|Safety Population. Only those participants available at the specified time points were analyzed.||Milliunits/Liter||Standard Deviation|Mean
756944|NCT00604825|Primary|Change From Baseline in Vital Sign of Heart Rate at Week 12|Heart rate was measured after the participant had rested for at least 5 minutes in a sitting or supine position. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. Mean change from Baseline in heart rate at Week 12 are presented.|Baseline (Week 0) and Week 12|Safety Population. Only those participants available at the specified time points were analyzed.||Beats per minute||Standard Deviation|Mean
756945|NCT00604825|Primary|Change From Baseline in Vital Signs of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 12|SBP and DBP were measured after the participant had rested for at least 5 minutes in a sitting or supine position. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. Mean change from Baseline in SBP and DBP at Week 12 are presented.|Baseline (Week 0) and Week 12|Safety Population. Only those participants available at the specified time points were analyzed.||Millimeters of mercury||Standard Deviation|Mean
756946|NCT00604825|Primary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) and Number of Participants With Mild, Moderate and Severe AE|AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant. The severity of AEs was assessed by the investigator as mild, moderate or severe.|Up to 21 weeks|Safety Population which comprised of all randomized participants who received at least one dose of investigational product.||Participants|||Count of Participants
756947|NCT00604851|Secondary|Unscheduled Heathcare Contacts||Baseline and 24 weeks||||||
756948|NCT00604851|Secondary|Lung Function||Baseline and 24 weeks||||||
756949|NCT00604851|Secondary|GER Symptoms||Baseline and 24 weeks||||||
756950|NCT00604851|Secondary|Asthma Symptom and Control Scores||Baseline and 24 weeks||||||
756951|NCT00604851|Primary|Change in Asthma Control Questionnaire Score at the 24 Week Visit.|The Asthma Control Questionnaire contains 7 items that are scored on a 7 point scale (range is 0 to 6). The scores are then summed and divided by 7 to reveal an overall score. A lower score indicates better asthma control. The results reflect the difference in the Asthma Control Questionnaire Score between baseline (randomization visit) and 24 weeks of treatment.|Baseline and 24 weeks|||Units on a scale||95% Confidence Interval|Mean
756952|NCT00604968|Secondary|Number of Days the Patients Were Hospitalized for Cancer-related Symptoms or Toxicity of Treatment|The cumulative sum of hospitalization days during the study, per patient. Some patients had multiple hospitalizations.|Time of treatment until treatment discontinuation (study planned to continue until all participants ended treatment).|Of the 25 total patients, 12 were hospitalized during the study.||days|||Number
756953|NCT00604968|Secondary|Duration of Overall Survival|Patients were followed with regards to survival even after they left the trial (ie after End of Treatment visit). Deaths that occurred after patient participation ended were collected all the way through to the overall end of the trial which took place on Oct 31, 2009. These deaths were used to calculate overall survival.|Time of treatment until death, up to the time that all participants ended treatment|||months||95% Confidence Interval|Median
756954|NCT00604968|Secondary|Time to Progression|"Progression is defined as the first evaluation that shows progression (either by RECIST or WHO criteria):
Progressive Disease according to RECIST response criteria: >=20% increase in the sum of the Longest Diameter of target lesions or unequivocal progression of non-target lesions. Appearance of new lesions will also constitute progressive disease.
Progressive Disease according to WHO response criteria: Increase in size of existing lesions or appearance of new lesions."|Time of treatment until progression, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment).|Of the 25 patients in the study 3 patients had non-measurable disease and could not be included in the progression analysis.||months||95% Confidence Interval|Median
756955|NCT00604968|Secondary|Duration of Response|"Duration of response is defined as the time span from the first evaluation that shows response until the first evaluation that shows progression. Where patients did not show progress, duration of response was measured from the first evaluation that showed response until they discontinued the study.
Response can be partial or complete (as previously defined), whichever status is recorded first."|Time of treatment until treatment discontinuation, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment).|Three patients showed Partial Response according to RECIST criteria.||weeks||Full Range|Median
756956|NCT00604968|Secondary|Time to Response|Response can be partial (>=30% decrease in the sum of Longest Diameter of target lesions, determined by two observations not less than 4 weeks apart; no unequivocal increase in the size of non-target lesions or the appearance of new lesions may occur) or complete (disappearance of all clinical evidence of tumor determined by 2 observations not less than 4 weeks apart), whichever status is recorded first.|Time of treatment until response, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment).|Only 3 patients had measureable time to response||Weeks||Full Range|Median
756957|NCT00604968|Secondary|Number of Patients Requiring Dose Reduction|The protocol contains instructions to reduce the Caelyx dose according to specific schedules, in cases necessary due to reasons such as hematological toxicity, non-hematological toxicity, cardiotoxicity, or other toxic side-effects of treatment reducing quality of life etc.|Time of treatment until treatment discontinuation (study planned to continue until all participants ended treatment).|||participants|||Number
767329|NCT00687973|Secondary|Change From Baseline of Aix at Week 24||Baseline and Week 24|Intent to treat (ITT) population; Last Observation Carried Forward (LOCF)||Ratio||Standard Error|Least Squares Mean
756958|NCT00604968|Secondary|Number of Patients With Progressive Disease (PD) as Best Response|"Response was calculated according to RECIST criteria except for bone metastasis where WHO criteria was used. For patients with skeletal disease only, WHO criteria was used. For patients with measurable disease according to RECIST as well as bone metastasis, both RECIST & WHO were used.
RECIST PD criteria required >=20% increase in certain target lesions OR progression of non-target lesions, or appearance of new lesions
WHO PD criteria required increase in size of existing lesions or appearance of new lesions."|Time of treatment until treatment discontinuation, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment).|10 patients were followed by RECIST, 4 patients were followed by WHO Response criteria, and 8 patients by both RECIST and WHO Response criteria (n=22). 3 patients had non-measurable disease and could not be included in the analysis.||participants|||Number
756959|NCT00604968|Secondary|Number of Patients With Partial Response (PR) as Best Response|"Response was calculated according to RECIST criteria except for bone metastasis where WHO criteria was used. For patients with skeletal disease only, WHO criteria was used. For patients with measurable disease according to RECIST as well as bone metastasis, both RECIST & WHO were used.
RECIST PR criteria required >=30% decrease in certain target lesions & no increase in size of non-target lesions or appearance of new lesions
WHO PR criteria required partial decrease in size of lytic lesions, recalcification of lytic lesions, or decreased density of blastic lesions for >=4 wks"|Time of treatment until treatment discontinuation, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment).|10 patients were followed by RECIST, 4 patients were followed by WHO Response criteria, and 8 patients by both RECIST and WHO Response criteria (n=22). 3 patients had non-measurable disease and could not be included in the analysis.||participants|||Number
756960|NCT00604968|Secondary|Number of Patients With Stable Disease (SD) as Best Response|"Response was calculated according to RECIST criteria except for bone metastasis where WHO criteria was used. For patients with skeletal disease only, WHO criteria was used. For patients with measurable disease according to RECIST as well as bone metastasis, both RECIST & WHO were used.
RECIST response criteria for SD required steady state of response of at least 9 weeks duration. There may be no appearance of new lesions.
WHO response criteria for SD required no significant change for at least 8 weeks."|Time of treatment until treatment discontinuation, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment).|10 patients were followed by RECIST, 4 patients were followed by WHO Response criteria, and 8 patients by both RECIST and WHO Response criteria (n=22). 3 patients had non-measurable disease and could not be included in the analysis.||participants|||Number
756961|NCT00604968|Primary|Time to Treatment Failure (Defined as Progression of Disease [According to the Response Evaluation Criteria in Solid Tumors (RECIST) or World Health Organization (WHO) Criteria] or Unacceptable Toxicity Leading to Discontinuation of Treatment or Death).|Treatment failure was defined as progression of disease (according to the RECIST or WHO criteria) or unacceptable toxicity leading to discontinuation of treatment or death. Progressive Disease according to RECIST response criteria: >=20% increase in the sum of the Longest Diameter of target lesions or unequivocal progression of non-target lesions. Appearance of new lesions will also constitute progressive disease. Progressive Disease according to WHO response criteria: Increase in size of existing lesions or appearance of new lesions.|Time of treatment until progression of disease or unacceptable toxicity leading to discontinuation of treatment or death, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment).|||Months||95% Confidence Interval|Median
756962|NCT00605033|Primary|Response Rate|Response rate was defined as the percentage of participants who did not receive a dose increase from the dose given at the first dosing date by Day 7 of a one-week, randomized, double-blind, double-dummy treatment transfer phase.|Assessed by Day 7 of double-blind, double-dummy treatment period.|Analysis of primary outcome was done on the intention-to-treat (ITT) population, defined as all randomized subjects who took at least one dose of study medication and provided at least one valid post-baseline assessment.||Percentage of participants|||Number
756963|NCT00605072|Primary|Cognitive Assessment: Forward Digit Span Test|This test consists of series of digits of increasing length, some of which are recited as presented, and some of which are to be recited in reversed order. The forward digit span score ranges from 0 (ie cannot repeat two digits) to 8 ( participant can repeat up to 8 digits)|Baseline-12 months|||number of digits repeated||Standard Error|Least Squares Mean
756964|NCT00605072|Primary|Cognitive Assessment: Hopkins Verbal Learning- Immediate Recall|This is a 12-item list learning test in which individuals are presented three learning and recall trials followed by a delayed recall and 24 item recognition test. The HVLT-R has been identified as an ideal memory measure for elderly patients, and appropriate reliability and validity have been shown in older individuals. The test score is the number of correct answers in the delayed recall ( score range 0-12)|Baseline-12 months|||number words remembered||Standard Error|Least Squares Mean
756965|NCT00605072|Secondary|Blood Flow Velocity, Sitting|This reports the change in the least square mean from baseline to 12 months, adjusted for age|Baseline-12 months|||cm/sec||Standard Error|Least Squares Mean
756966|NCT00605072|Secondary|Blood Pressure Outcome: Systolic BP|Blood pressure was measured as follows: the participant was in the sitting position, rested for 5 minutes, no caffeine or smoking 2 hours prior to measurement, using appropriate cuff size (covering 60% of upper arm length and 80% of arm circumference), correct cuff placement (1-2 inches above brachial pulse on bare arm), and the bell of the stethoscope. The systolic blood pressure was defined as the pressure corresponding to the first korotkoff sounds (K1) and the diastolic as the pressure corresponding to the last korotkoff sound (K5). Blood pressure was measured in both arms and recorded|Baseline-12 months|||mm Hg||Standard Error|Least Squares Mean
756967|NCT00605072|Primary|Cognitive Assessment: Trail Making Test Part B|This test requires the connection of sequentially numbered circles (A), and the connection of circles marked by numbers and letters in alternating sequence (B). This test is considered a benchmark of executive function. The test score is the time required to complete the task in seconds.|Baseline-12 months|||seconds||Standard Error|Least Squares Mean
756968|NCT00605085|Secondary|SCR and GMT of Subjects With Concomitant Vaccinations||until Day 56||||||
756969|NCT00605085|Secondary|Changes in Laboratory Parameters||until Day 56||||||
756970|NCT00605085|Secondary|Rates of Serious Adverse Events and Medically Attended Adverse Events||until Day 56||||||
756974|NCT00605176|Secondary|Local Skin Reactions|Six local skin reaction (LSR) signs were predefined and were assessed for presence and intensity at each study visit. These included: Erythema, Edema, Weeping/Exudate, Flaking/Scaling/Dryness, Scabbing/Crusting and Erosion/Ulceration. The LSRs were scored as 0=none, 1=mild, 2=moderate, 3=severe. Mean scores were summated over time (14 weeks) to yield a mean LSR AUC (area under the curve)|At all visits - from Baseline to End of study (Week 14)|All participants were evaluated for local skin reactions (LSR) at every visit. Summary of LSR - area under the curve (AUC) of sum of LSR Scores (days). ITT population. The time period for the AUC extends to 8 weeks after the end of treatment (Week 14). Only subjects who received treatment in both treatment cycles are included in this analysis.||units on a scale * days||Standard Deviation|Mean
756975|NCT00605176|Secondary|Percent Change From Baseline in AK Lesion Count|Percent change from Baseline to end of study (EOS) in investigator counts of AK lesions.|From baseline to End of Study the Week 14 visit|Intent to treat (ITT) Last Observation Carried Forward (LOCF)||percent change||Full Range|Median
756976|NCT00605176|Secondary|Number of Participants With Partial Clearance of AK Lesions|Subject status with respect to partial clearance of AK lesions at end of study (EOS), defined as at least a 75% reduction in the number of AK lesions in the treatment area compared with Baseline.|End of Study the Week 14 visit|Efficacy analyses were conducted on the intent-to-treat (ITT) population. Imputations were made for missing data points using last observation carried forward (LOCF).||participants|||Number
756977|NCT00605176|Primary|Number of Participants With Complete Clearance of AK Lesions|Subject status with respect to complete clearance of AK lesions at End of Study (EOS), ie, the Week 14 visit. Complete clearance was defined as the absence of clinically visible or palpable AK lesions in the treatment area. All lesions within the identified treatment area were included in the count, even if the lesion was a new lesion or ‘subclinical’ lesion that had not been identified at Baseline.|End of Study the Week 14 visit|Efficacy analyses were conducted on the intent-to-treat (ITT) population. For the primary efficacy variable, imputations were made for missing data points using last observation carried forward (LOCF, primary analysis), taking all missed observations as failure (sensitivity analysis), and using observed cases only (supportive analysis).||participants|||Number
756978|NCT00605202|Primary|Plasma Potassium|Plasma potassium measured with indirect ion specific electrode method|Baseline and 2 weeks|||mmol/l||Standard Deviation|Mean
756979|NCT00605267|Secondary|Anastrozole Plasma Concentrations (Cmin)|Trough Plasma concentrations (Cmin) of Anastrozole - only Anastrozole arm was evaluated for Trough Plasma concentrations.|Assessed at week 12|||ng/mL||Full Range|Geometric Mean
756980|NCT00605267|Secondary|Endocrine Subscale (ES)|"Change from baseline in Endocrine Symptom Subscale (ES)) in the ITT population at 24 weeks. ES score = the sum of the responses to all the questions on ES, low scores reflect poor quality of life and high scores reflects better quality of life.
Score range: 0-72"|Assessed at baseline and after 24 weeks of treatment|Difference of Endocrine Subscale (ES) = ES at 24 weeks – ES at baseline.||ES score||Standard Deviation|Mean
756981|NCT00605267|Secondary|Functional Assessment of Cancer Therapy-Breast (FACT-B)|"Change from baseline in Functional Assessment of Cancer Therapy-Breast (FACT-B)in the ITT population at 24 weeks. Trial Outcome Index (TOI) = the sum of the Physical Well-Being (PWB), Functional Well-Being (FWB), and Breast Cancer Scale (BCS) subscales of FACT-B.
FACT-B includes 36 questions; 7 in PWB (Physical Well-Being); 7 inSWB (Social / Family Well-Being); 6 in EWB (Emotional Well-Being); 7 in FWB (Functional Well-Being); 9 in BCS (Breast Cancer Subscale).
Total score of subscores or TOI is calculated from each score of question. Higher score means better and lower score means worthier.
Score range; 0-28 in PWB; 0-28 in SWB; 0-24 in EWB; 0-28 in FWB; 0-36 in BCS; 0-92 in TOI."|Assessed at baseline and after 24 weeks of treatment|"Total score of subscores or TOI is calculated from each score of question. Higher score means better and lower score means worthier.
PWB, FWB and BCS were assessed in this study. TOI was a total of PWB, FWB and BCS."||Trial Outcome Index (TOI) (Prorated)||Standard Deviation|Mean
756982|NCT00605267|Secondary|Histopathological Response Rate (HRR)|Number of patients in the ITT population defined as histopathological responders over the total number of patients x 100. An histopathological responder = a patient classified as Grade 1b, 2 or 3 for the histopathological response (Grade 0 = no response, 1a = mild response, 1b = moderate response, 2 = marked response or 3 = complete response)|Assessed at baseline and after 24 weeks of treatment|||Percentage of Participants|||Number
756983|NCT00605267|Secondary|Human Epidermal Growth Factor Receptor 2 (HER2) Status|HER2 status in the ITT population is categorized as Positive or Negative|Assessed at baseline and after 24 weeks of treatment|||Participants|||Number
756984|NCT00605267|Secondary|Progesterone Receptor (PgR) Status|PgR status in the ITT population is categorized as Positive or Negative.|Assessed at baseline and after 24 weeks of treatment|||Participants|||Number
756985|NCT00605267|Secondary|Oestrogen Receptor (ER) Status|ER status in the ITT population is categorized as Positive or Negative|Assessed at baseline and after 24 weeks of treatment|||Participants|||Number
756986|NCT00605267|Secondary|Serum Oestradiol (E2) Concentrations|Ratio of serum Oestradiol (E2) concentration (pg/mL) in the ITT population from baseline at 24 weeks.|Assessed at baseline and after 24 weeks of treatment|||Ratio||Standard Deviation|Mean
756987|NCT00605267|Secondary|Serum Oestrone (E1) Concentrations|Ratio of serum Oestrone (E1) concentration (pg/mL) in the ITT population from baseline at 24 weeks.|Assessed at baseline and after 24 weeks of treatment|||Ratio||Standard Deviation|Mean
756988|NCT00605267|Secondary|Bone Turnover Marker (NTX)|Change from baseline in serum crosslinked N-Telopeptide of type I collagen (NTX) at 24 weeks|Assessed at baseline and after 24 weeks of treatment|||nmolBCE(Bone Collagen Equivalent) /L||Standard Deviation|Mean
756989|NCT00605267|Secondary|Bone Turnover Marker (BAP) CLEIA Method|Change from baseline in serum Bone-Alkaline Phosphatase (BAP) at 24 weeks measured by CLEIA method|Assessed at baseline and after 24 weeks of treatment|||ug/L||Standard Deviation|Mean
756990|NCT00605267|Secondary|Bone Turnover Marker (BAP) EIA Method|Change from baseline in serum Bone-Alkaline Phosphatase (BAP) at 24 weeks measured by EIA method|Assessed at baseline and after 24 weeks of treatment|||U/L||Standard Deviation|Mean
756991|NCT00605267|Secondary|Bone Mineral Density (BMD) Cervical Thighbone|Change from baseline in Bone Mineral Density value (percentage), in all subjects who used DXA(Dual-energy X-ray absorptiometry) method throughout the study, at 24 weeks measured at cervical thighbone.|Assessed at baseline and after 24 weeks of treatment|Difference of percentage Bone Mineral Density (BMD) Cervical Thighbone = BMD percentage at 24 weeks – BMD percentage at baseline||PercentageBMD=Patient'sBMD/standard BMD)||Standard Deviation|Mean
756992|NCT00605267|Secondary|Bone Mineral Density (BMD) Lumbar Spine|Change from baseline in Bone Mineral Density value (percentage), in all subjects who used DXA(Dual-energy X-ray absorptiometry) method throughout the study, at 24 weeks measured at lumbar spine.|Assessed at baseline and after 24 weeks of treatment|The standard BMD value is defined by Japanese Osteoporosis Society in the table of reference values showing the mean for the age, gender, race, skeletal site, and densitometer measurement units was used. Then the formula was used at each measurement data: BMD(%) = Patient's BMD / standard BMD) x 100||PercentageBMD=Patient's BMD/standard BMD||Standard Deviation|Mean
756993|NCT00605267|Primary|Best Overall Response Rate (BORR) (MRI/CT)|"The BORR were defined as the percentage of patients with confirmed CR or PR in the ITT population during 24 weeks pre-operative treatment period(based on the data from magnetic resonance imaging (MRI) or computed tomography (CT) measurement).
CR (or PR) criteria are met at either 12 weeks or 24 weeks. Per RECIST Criteria (V1.0) and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|24 weeks|||Percentage of Participants|||Number
756994|NCT00605267|Primary|Best Overall Response Rate (BORR) (US)|"The BORR were defined as the percentage of patients with confirmed CR or PR in the ITT population during 24 weeks pre-operative treatment period (based on the data from ultra sound (US) measurement).
CR (or PR) criteria are met at 2 or more time in points every 4 weeks. Per RECIST Criteria (V1.0) and assessed by US: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|24 weeks|||Participants|||Number
756995|NCT00605267|Primary|Best Overall Response Rate (BORR) (Calliper)|"The BORR were defined as the percentage of patients with confirmed CR or PR in the ITT population during 24 weeks pre-operative treatment period (based on the data from calliper measurement).
CR (or PR) criteria are met at 2 or more time in points every 4 weeks. Per RECIST Criteria (V1.0) and assessed by Calliper: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|24 weeks|"The BORR were defined as the percentage of patients with confirmed CR or PR in the ITT population during 24 weeks pre-operative treatment period.
At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter"||Percentage of Participants|||Number
756996|NCT00605280|Secondary|Number of Participants Requiring Focal or Grid Laser Treatment During Year 2|Included focal laser coagulation, focal laser photocoagulation, panretinal laser photocoagulation, retinal laser coagulation, and retinal laser photocoagulation|2 years|FAS2 population||Participants|||Number
756997|NCT00605280|Secondary|Number of Participants Requiring Focal or Grid Laser Treatment During Year 1|Included focal laser coagulation, focal laser photocoagulation, panretinal laser photocoagulation, retinal laser coagulation, and retinal laser photocoagulation|1 year|MITT1 population||Participants|||Number
756998|NCT00605280|Secondary|Change From Baseline in Mean VA Score at 2 Years|Changes in VA monitored through refraction and best-corrected VA measurements using retro-illuminated, modified Ferris-Bailey ETDRS chart with participants at a 4-meter distance from chart. Distance VA expressed as an ETDRS score (number of letters correctly read) ranging from 0 to 60, where higher ETDRS scores represented better vision. Change from baseline for each patient equaled the visual acuity obtained at the observation minus the visual acuity at baseline.|Baseline, Year 2|FAS2 population. LOCF.||Scores on a scale||Standard Deviation|Mean
756999|NCT00605280|Secondary|Change From Baseline in Mean VA Score at 1 Year|Changes in VA monitored through refraction and best-corrected VA measurements using retro-illuminated, modified Ferris-Bailey ETDRS chart with participants at a 4-meter distance from chart. Distance VA expressed as an ETDRS score (number of letters correctly read) ranging from 0 to 60, where higher ETDRS scores represented better vision. Change from baseline for each patient equaled the visual acuity obtained at the observation minus the visual acuity at baseline.|Baseline, Year 1|MITT1 population. LOCF.||scores on a scale||Standard Deviation|Mean
757000|NCT00605280|Secondary|Number of Eyes With a 2 or More Step Decrease in Degree of Retinopathy at 2 Years|Retinopathy changes were monitored using fundus photography and FA assessments. An Independent Reading Center, using trained graders, evaluated the presence of retinopathy using a modified 12-step version of the ETDRS Final Retinopathy Severity Scale, that ranged from step 1 (retinopathy level of 10 or 12) to step 12 (retinopathy level of 85A or 85B) where a decrease in the step or retinopathy level indicated an improvement.|Baseline, Year 2|FAS2 population. Number of participants analyzed (N) = participants with evaluable data. Only 1 eye per participant was assessed in this study. LOCF.||Eyes|||Number
757001|NCT00605280|Secondary|Number of Eyes With a 2 or More Step Increase in Degree of Retinopathy at 2 Years|Retinopathy changes were monitored using fundus photography and FA assessments. An Independent Reading Center, using trained graders, evaluated the presence of retinopathy using a modified 12-step version of the ETDRS Final Retinopathy Severity Scale, that ranged from step 1 (retinopathy level of 10 or 12) to step 12 (retinopathy level of 85A or 85B) where an increase in the step or retinopathy level indicated a worsening of the condition.|Baseline, Year 2|FAS2 population. Number of participants analyzed (N) = participants with evaluable data. Only 1 eye per participant was assessed in this study. LOCF.||Eyes|||Number
757002|NCT00605280|Secondary|Number of Eyes With a 2 or More Step Decrease in Degree of Retinopathy at 1 Year|Retinopathy changes were monitored using fundus photography and FA assessments. An Independent Reading Center, using trained graders, evaluated the presence of retinopathy using a modified 12-step version of the ETDRS Final Retinopathy Severity Scale, that ranged from step 1 (retinopathy level of 10 or 12) to step 12 (retinopathy level of 85A or 85B) where a decrease in the step or retinopathy level indicated an improvement.|Baseline, Year 1|Evaluable participants from MITT1 population. Only 1 eye per participant was assessed in this study. LOCF.||Eyes|||Number
757003|NCT00605280|Secondary|Number of Eyes With a 2 or More Step Increase in Degree of Retinopathy at 1 Year|Retinopathy changes were monitored using fundus photography and fluorescein angiograph (FA) assessments. An Independent Reading Center, using trained graders, evaluated the presence of retinopathy using a modified 12-step version of the ETDRS Final Retinopathy Severity Scale, that ranged from step 1 (retinopathy level of 10 or 12) to step 12 (retinopathy level of 85A or 85B) where an increase in the step or retinopathy level indicated a worsening of the condition.|Baseline, Year 1|Evaluable participants from MITT1 population. Only 1 eye per participant was assessed in this study. LOCF.||Eyes|||Number
757006|NCT00605280|Secondary|Number of Participants With a ≥ 10 Letter (or 2 Line) Improvement in Vision at 2 Years|Refraction and best-corrected VA measurements were performed using retro-illuminated, modified Ferris-Bailey ETDRS charts|Baseline, Year 2|Full Analysis Set (FAS)2 population:participants who had same treatment for 102 weeks (pegaptanib sodium or sham on/before Week 96) with baseline VA assessment, who met the following: had at least 1 post baseline VA within 2 years, before entry into the Year 3 open-label extension phase, or before withdrawing from the study prior to Week 102. LOCF.||Participants|||Number
757007|NCT00605280|Primary|Number of Participants With Greater Than or Equal to ≥10 Letter (or 2 Line) Improvement in Vision at 1 Year|Refraction and best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts|Baseline, Year 1|Modified Intent-to-Treat (MITT)1 population:participants with at least 1 dose of study treatment who completed baseline VA, had at least 1 post baseline VA assessment within 1 year; 2 sites not analyzed due to Good Clinical Practice deviations; the 0.03 and 0.003mg pegaptanib arms not analyzed for efficacy. Last Observation Carried Forward (LOCF).||Participants|||Number
757008|NCT00605293|Secondary|Percentage of Participants Who Received Red Blood Cell (RBC) Transfusions During DTP and EEP|RBC transfusions could be given during the study in case of medical need, i.e., in severely anemic participants with recognized symptoms or signs of anemia (e.g., in participants with acute blood loss, with severe angina, or whose hemoglobin decreased to critical levels).|DTP (Week 0 to 15) up to EEP (Week 16 to 23)|ITT population||percentage of participants|||Number
757009|NCT00605293|Secondary|Percentage of Participants Who Required Dose Adjustments During the DTP and EEP||DTP (Week 0 to 15) and EEP (Week 16 to 23)|"Safety population included all those participants who were treated with at least one dose of the trial medication and had a safety follow-up, whether withdrawn prematurely or not. Here, n = participants who were evaluable for each category, for respective arm groups."||percentage of participants|||Number
757010|NCT00605293|Secondary|Mean Time Spent in Hb Range 10-12 g/dL||SVP (Week -4 to -1), DTP (Week 0 to 15), and EEP (Week 16 to 23)|ITT population. Here, n = participants who were evaluable for each category, for respective arm groups.||days||Standard Deviation|Mean
757011|NCT00605293|Secondary|Percentage of Participants Who Maintained Hb Concentration Between 10 and 12 g/dL Throughout the EEP|Participants who maintained Hb concentration between 10 to 12 g/dL throughout the EEP are reported.|EEP (Week 16 to 23)|ITT population||percentage of participants|||Number
757012|NCT00605293|Secondary|Change in Hb Concentrations Between Baseline SVP and the EEP|Change in Hb concentration between baseline SVP and the EEP was evaluated by subtracting the mean of Hb concentration during the SVP (Weeks -4 to -1) with the mean of Hb concentration during the EEP (Weeks 16 to 23).|SVP (Week -4 to -1), EEP (Week 16 to 23)|ITT population.||g/dL||Standard Deviation|Mean
757013|NCT00605293|Primary|Percentage of Participants Who Maintained Average Hemoglobin (Hb) Concentration Within Plus Minus (+/-) 1 Grams Per Deciliter (g/dL) of Their Reference Hb and Between 10 and 12 g/dL During the EEP|Participants who maintained average Hb concentration within +/-1 g/dL of their reference Hb and between 10 to 12 g/dL during EEP are reported. The reference Hb value was defined on the basis of all assessments at Weeks -4, -3, -2, -1 and 0.|EEP (Week 16 to 23)|Per Protocol (PP) population was as a subset of the ITT population who completed the study without any major protocol deviations.||percentage of participants||95% Confidence Interval|Number
757014|NCT00605306|Secondary|Levels of Serum Cortisol Over Time|At the specified time-points, blood samples were collected for measurement of serum cortisol and the samples analyzed by a central laboratory. The end of study visit was conducted approximately 5-9 days after the last dose.|Baseline; Days 1 and 14 at pre-dose, 0.25, 0.5, 1, 2, 4, 11, 12, 13 hours post-dose; 24 hours post dose (Day 2); study completion (5-9 days after last dose, Day 19-23).|All participants||mmol/L||Standard Deviation|Mean
757015|NCT00605306|Secondary|Levels of Plasma Glucose Over Time|At the specified time-points, blood samples were collected for measurement of plasma glucose and the samples analyzed by a central laboratory. The end of study visit was conducted approximately 5-9 days after the last dose.|Baseline; Days 1 and 14 at pre-dose, 0.25, 0.5, 1, 2, 4 hours post-dose; 12 and 24 hours post dose (Day 2); study completion (5-9 days after last dose, Day 19-23).|All participants||mmol/L||Standard Deviation|Mean
757016|NCT00605306|Secondary|Levels of Serum Potassium Over Time|At the specified time-points, blood samples were collected for measurement of serum potassium and the samples analyzed by a central laboratory. The end of study visit was conducted approximately 5-9 days after the last dose.|Baseline; Days 1 and 14 at pre-dose, 0.25, 0.5, 1, 2, 4 hours post-dose; 12 and 24 hours post-dose (Day 2); study completion (5-9 days after last dose, Day 19-23).|All participants||mmol/L||Standard Deviation|Mean
757017|NCT00605306|Primary|Participants With Adverse Events|"An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Abnormal laboratory values or test results constitute adverse events only if they induce clinical signs or symptoms, are considered clinically significant, or require intervention.
A serious adverse event (SAE) is defined as an event which is fatal or life-threatening, results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, requires inpatient hospitalization or prolongation of existing hospitalization, or is medically significant, i.e., defined as an event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the outcomes listed above."|15 days|All participants||participants|||Number
757018|NCT00605345|Secondary|Incidence of RBC Transfusions|Assessment of the Dose Titration Period of 16 weeks of treatment and following 12 weeks, known as the Efficacy Evaluation Period (EEP).|Up to 28 weeks|Analysis performed with the intent to treat (ITT) population, which includes all participants receiving at least one dose of the study drug.||participants|||Number
757019|NCT00605345|Secondary|Percentage of Participants Needing Dose Adjustments|Assessment of the Dose Titration Period of 16 weeks of treatment and following 12 weeks, known as the Efficacy Evaluation Period (EEP).|Up to 28 weeks|Analysis was performed on the safety population.||percentage of participants|||Number
757020|NCT00605345|Secondary|Mean Time Spent in 10-12g/dL Range During the Efficacy Evaluation Period (EEP)|Efficacy Evaluation Period was the 12 weeks following 16 weeks of treatment in the Dose Titration Period.|Weeks 16-28|Analysis was performed using the intent to treat (ITT) population, which includes all participants receiving at least one dose of the study drug.||days||Standard Deviation|Mean
757022|NCT00605345|Secondary|Mean Change in Hb Concentration From Baseline to Efficacy Evaluation Period (EEP)|Reference haemoglobin at baseline is defined as the mean of the two assessments recorded at weeks -4 and -2. Additional assessments were then performed every 4 weeks at week 0 through week 28. Mean change was calculated as value at 28 weeks minus baseline.|Baseline to 28 weeks|Analysis performed in the Intent toTreat (ITT) population, which includes all participants receiving at least one dose of the study drug.||g/dL||Standard Deviation|Mean
757023|NCT00605345|Primary|The Percentage of Participants Maintaining Average Haemoglobin (Hb) Concentration During the Efficacy Evaluation Period (EEP) Within the Target Range|Key outcomes will be assessed during the first 12 weeks following the 16 weeks dose titration period, i.e. during the Efficacy Evaluation Period (EEP). Assessments performed every four weeks, beginning at week 16 up to week 28. The reference haemoglobin is defined as the mean of the two assessments recorded during the SVP (weeks -4 and -2). For the purposes of efficacy assessment the target haemoglobin concentration range will be defined as ± 1 g/dL of the reference haemoglobin concentration AND within the range 10 – 12 g/dL.|Weeks 16-28|Analysis was performed in the per protocol (PP) population.||percentage of participants||95% Confidence Interval|Number
757024|NCT00605358|Primary|The Primary Outcome is Engagement Defined as at Least One Visit With a Mental Health Provider Who Can Offer Treatment of Depression.|"Engagement was defined as at least one visit with a mental health provider, due to the fact that in some treatment settings, the initial evaluation and the onset of treatment both took place in the first visit.
The primary outcome, engagement, was counted if the participant had engaged in mental health treatment by EITHER 12 weeks OR 24 weeks, based on research suggesting that older adults may take up to 6 months to follow through on a referral.
Therefore, while there is only a single primary outcome (engaged or not), it could be fulfilled at either of the two follow-up time points, at 12 or 24 weeks."|12 and 24 weeks|||percentage of participants|||Number
757025|NCT00605384|Secondary|Number of Participants With Genotypic Resistance Based on Analysis of Samples From Participants With HBV DNA ≥ 50 IU/mL at Weeks 48 and 96|HBV DNA ≥ 50 IU/mL = approximately 300 copies/mL|Week 48, Week 96|Due to early study termination, none of the efficacy endpoints were analyzed.||participants|||Number
757026|NCT00605384|Secondary|Number of Participants With HBs Seroconversion (HBsAg Loss and Presence of HBsAb) at Weeks 48 and 96|Hepatitis B surface antigen (HBsAg) = a part of the hepatitis B virus that, when in the blood, is an early marker of infection. HBsAb = HBsAg antibodies. HBs Seroconversion = HBsAg loss and presence of HBseAb|Week 48, Week 96|Due to early study termination, none of the efficacy endpoints were analyzed.||participants|||Number
757027|NCT00605384|Secondary|Number of Participants With Hepatitis-B-Virus Surface Antigen of the (HBsAg) Loss at Weeks 48 and 96|Hepatitis B surface antigen (HBsAg) = a part of the hepatitis B virus that, when in the blood, is an early marker of infection|Week 48, Week 96|Due to early study termination, none of the efficacy endpoints were analyzed.||participants|||Number
757028|NCT00605384|Secondary|Number of Participants Who Were HBeAg-positive at Baseline With HBe Seroconversion at Weeks 48 and 96|HBe seroconversion = HBeAg loss and presence of hepatitis B e-antibody (HBeAb)|Baseline, Week 48, Week 96|Due to early study termination, none of the efficacy endpoints were analyzed.||participants|||Number
757029|NCT00605384|Secondary|Number of Participants Who Were Hepatitis B E-antigen (HBeAg)-Positive at Baseline With Loss of HBeAg at Weeks 48 and 96|HBeAg is a hepatitis B viral protein. It is an indicator of active viral replication.|Baseline, Week 48, Week 96|Due to early study termination, none of the efficacy endpoints was analyzed.||Participants|||Number
757030|NCT00605384|Secondary|Number of Participants With Alanine Aminotransferase (ALT) > 1 x Upper Limit of Normal (ULN) at Baseline Who Achieved ALT Normalization (≤ 1 x ULN) at Weeks 48 and 96||Week 48, Week 96|Due to early study termination, none of the efficacy endpoints were analyzed.||Participants|||Number
757031|NCT00605384|Secondary|Mean log10 Reduction From Baseline in HBV DNA at Weeks 48 and 96|by PCR, using the Roche COBAS®TaqMan - HPS assay|Week 48, Week 96|Due to early study termination, none of the efficacy endpoints was analyzed.||log10||Standard Deviation|Mean
757032|NCT00605384|Secondary|HBV DNA Values at Weeks 48 and 96|Number of Participants with HBV DNA <LLD (4.8); LLD to <50; 50 to <172; 172 to <1,720; 1,720 to <17,200; and ≥17,200 IU/mL (<LLD (28); 28 to <300; 300 to <1,000; 1,000 to <10,000; 10,000 to <100,000; and ≥100,000 copies/mL by PCR, using the Roche COBAS®TaqMan - HPS assay|Weeks 48, Week 96|Due to early study termination, none of the efficacy endpoints were analyzed.||participants|||Number
757033|NCT00605384|Secondary|Number of Participants Who Achieved HBV DNA < the Lower Limit of Detection (LLD) at Weeks 48 and 96|by PCR, using the Roche for the Roche COBAS® TaqMan - HPS assay. LLD = 4.8 IU/mL (approximately 28 copies/mL)|Week 48, Week 96|Due to early study termination, none of the efficacy endpoints were analyzed.||participants|||Number
757034|NCT00605384|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs or Laboratory Abnormalities|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, and/or is an important medical event.|Day 1 through end of treatment (Week 100 +/- 5 days)|All treated participants. Timeframe for Outcome Measure revised due to study termination. (Study Completion Date=February 2009).||participants|||Number
757035|NCT00605384|Secondary|Number of Participants Who Achieved an HBV DNA Level <50 IU/mL at Week 96|by PCR, using the Roche COBAS®TaqMan - HPS assay; HBV DNA < 50 IU/mL = approximately 300 copies/mL.|Week 96|Due to early study termination, none of the efficacy endpoints were analyzed.||participants|||Number
757036|NCT00605384|Primary|Number of Participants Who Achieved an Hepatitis B Virus DNA (HBV DNA) Level < 50 IU/mL at Week 48|using the Roche COBAS® TaqMan HBV Test for use with the High Pure System (HPS) assay, by Polymerase Chain Reaction (PCR); HBV DNA < 50 IU/mL = approximately 300 copies/mL|Week 48|Due to early study termination, none of the efficacy endpoints were analyzed.||Participants|||Number
757037|NCT00605423|Secondary|Change in IOP From Baseline|IOP stands for intra ocular pressure|6 mos|||mmHg||Standard Deviation|Mean
757038|NCT00605423|Secondary|Number of Patients Developing Cataracts||6 mos|||participants|||Number
757039|NCT00605423|Primary|Mean Change From Baseline in Visual Acuity|Visual acuity is measured using ETDRS charts at 4 meters.|6 mos|||ETDRS letters||Standard Deviation|Mean
757040|NCT00605475|Secondary|Number of Participants Reporting Death, Serious Adverse Events (SAEs), Adverse Events (AE) Above 5% Frequency|An adverse event is any unwanted event, whether related to study drug or not occurring during the study period. A Serious Adverse Event (SAE) is an event resulting in death, requiring or prolonging hospitalization, a congenital anomaly or other important medical event. AEs and SAEs were recorded at each visit.|Baseline to End of Study (56[+/-2] and 168 [+/- 5] days after dosing for Cohort 1 and Cohorts 2-4, respectively)|All randomized participants who received study medication were included in the Safety Analysis||Participants|||Number
757041|NCT00605475|Secondary|β-cell Function as Measured by the Homeostatic Model Assessment (HOMA-β )|β cell function is measured by the Homeostatic Model Assessment(HOMA-β) using a computer to model β cell function and insulin sensitivity . β cell function is related to Insulin Sensitivity (HOMA-%S) and is the reciprocal of insulin resistance (100/S%). HOMA β = [20 x fasting insulin (μU/mL)] / [fasting plasma glucose (mmol/L) – 3.5] where fasting insulin (or glucose) was defined as the arithmetic mean of the -15, -10 and 0 min pre-glucose load values. Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed on log transformed data.|Baseline, Day 28, Day 84|All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.||percent β-cell Function||Standard Error|Geometric Mean
757042|NCT00605475|Secondary|Insulin Resistance as Measured by the Homeostatic Model Assessment (HOMA-IR)|Insulin Resistance is measured via the Homeostatic Model Assessment (HOMA-IR) using a computer to model insulin sensitivity. Insulin Sensitivity (HOMA-%S), where 100% is normal, is the reciprocal of insulin resistance (100/S%). HOMA IR = [fasting insulin (μU/mL)] x [fasting plasma glucose (mmol/L)] / 22.5 where fasting insulin (or glucose) was defined as the arithmetic mean of the -15, -10 and 0 min pre-glucose load values. Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed on log transformed data.|Baseline, Day 28, Day 84|All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.||units on a scale||Standard Error|Geometric Mean
757043|NCT00605475|Secondary|Mean Change From Baseline in Peak Plasma Fructosamine Level|Blood was drawn to measure change in plasma Fructosamine Level, from baseline to Day 14, 28, 56, 84, 126 and End of Study ( defined as the final available post-randomization assessment up to the last regularly scheduled visit at Day 168 [+/- 5]). Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.|Baseline, Day 14, Day 28, Day 56, Day 84, Day 126, End of Study (168 [+/- 5] days after dosing)|All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.||µmol/L||Standard Error|Least Squares Mean
757044|NCT00605475|Secondary|Mean Change From Baseline in Peak Plasma Glucose Following Oral Glucose Tolerance Test ( OGTT )|Mean Change in Peak Glucose level stimulated by OGTT. Blood samples were taken at sample times: -20, -10, -1 and 10, 20, 30, 60, 90, 120, 180, and 240 minutes. Change from baseline assessed at Day 28 and 84. Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.|Baseline, Day 28, Day 84|All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.||mmol/L||Standard Error|Least Squares Mean
757045|NCT00605475|Secondary|Insulinogenic Index, 0 - 30 Minutes|"Insulinogenic index (0-30 min)
[Change in insulin (0-30 min) (μIU/mL)] / [Change in glucose (0-30 min) (mg/dL)]
[insulin (μIU/mL) at 30 min – insulin (μIU/mL) at 0 min] / [glucose (mg/dL) at 30 min – glucose (mg/dL) at 0 min), where insulin (or glucose) at 0 min was defined as the arithmetic mean of the -15, -10 and 0 min pre-glucose load values. Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed on log transformed data.."|Day 28, Day 84|All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.||units on a scale||Standard Error|Geometric Mean
757046|NCT00605475|Secondary|Insulin Sensitivity Index ( ISI ) at Day 28, Day 48|Insulin sensitivity index (ISI) = 10000 / [fasting insulin (μIU/mL) x fasting glucose (mg/dL) x mean 2 hour insulin(μIU/mL) x mean 2 hour glucose (mg/dL)]1/2 where mean 2 hour insulin (or glucose) was defined as the insulin (or glucose)AUC(0-2 hr) divided by the time period (2 hr). In normal subjects the mean score ± SE is 0.366 ± 0.029. Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed on log transformed data.|Day 28, Day 84|All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.||units on a scale||Standard Error|Geometric Mean
757047|NCT00605475|Secondary|Mean Insulin Secretion Rate ( ISR ), 0 - 4 Hours|Blood samples were taken at sample times: -20, -10, -1 and 10, 20, 30, 60, 90, 120, 180, and 240 minutes. The mean ISR over 0 - 4 hours was computed as an AUC (area under the curve) using the linear trapezoidal rule divided by the corresponding time interval. Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.|Day 28, Day 84|All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.||pmol/min/m^2||Standard Error|Least Squares Mean
757048|NCT00605475|Secondary|Mean Insulin Secretion Rate ( ISR ) Relative to Glucose, 0 - 4 Hours|"Blood samples were taken at sample times: -20, -10, -1 and 10, 20, 30, 60, 90, 120, 180, and 240 minutes. Mean ISR relative to glucose over 0-4 hours was calculated as follows:
Mean ISR relative to glucose = mean ISR / (glucose AUC/time interval). The mean ISR was computed as an AUC (area under the curve) using the linear trapezoidal rule divided by the corresponding time interval. Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed."|Day 28, Day 84|All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.||pmol/min/m^2/mmol/L||Standard Error|Least Squares Mean
757062|NCT00605657|Primary|Number of Participants With Response|Reduction of lymph node and/or spleen size measured by CT imaging, or physical exam and abdominal ultrasound. A clinical response is defined as a greater than 40% reduction in lymph node size and/or greater than 40% reduction in spleen size. A CT scan with contrast measured lymph node size as well as spleen size.|3 monthly (12 week) intervals|||participants|||Number
786174|NCT00833690|Secondary|Change in Serum Urate|Change from an Average of Baseline and Screening Visits|Visit 04 from Baseline (i.e., between -45 days and +9 weeks)|||mg/dL||Standard Deviation|Mean
757049|NCT00605475|Secondary|Mean Change From Baseline in Peak Plasma Insulin/Proinsulin Level, Following Oral Glucose Tolerance Test (OGTT)|Blood samples were drawn after an overnight fast and OGTT at 0, 15, 30, 45, 60, 90, 120, 180 and 240 min. Insulin and proinsulin levels were measured. The insulin/proinsulin level was calculated by dividing the insulin level by the proinsulin level. Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.|Baseline, Day 28, Day 84|All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.||pmol/pmol||Standard Error|Least Squares Mean
757050|NCT00605475|Primary|Mean Change From Baseline in Plasma Glucose Area Under the Curve (AUC) 0 - 4 Hours Following Oral Glucose Tolerance Test (OGTT )|Mean Change in Glucose level stimulated by OGTT. Blood samples were taken at sample times: -20, -10, -1 and 10, 20, 30, 60, 90, 120, 180, and 240 minutes. Glucose levels over 4 hrs were shown as Area Under the Curve, (AUC). Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.|Baseline, Day 28, Day 84|All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.||mmol*h/L||Standard Error|Least Squares Mean
757051|NCT00605475|Secondary|Mean Change From Baseline in Plasma Glucagon AUC ( Area Under the Curve) 0-4 Hours, Following Oral Glucose Tolerance Test|Blood samples were drawn after an overnight fast and OGTT at 0, 15, 30, 45, 60, 90, 120, 180 and 240 min. Glucagon levels over 4 hrs were shown as Area Under the Curve, (AUC). Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.|Baseline, Day 28, Day 84|All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.||pmol*h/L||Standard Error|Least Squares Mean
757052|NCT00605475|Secondary|Mean Change From Baseline in Plasma Proinsulin AUC ( Area Under the Curve) 0-4 Hours, Following Oral Glucose Tolerance Test ( OGTT )|Blood samples were drawn after an overnight fast and OGTT at 0, 15, 30, 45, 60, 90, 120, 180 and 240 min. Insulin levels over 4 hrs were shown as Area Under the Curve, (AUC). Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.|Baseline, Day 28, Day 84|All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.||pmol*h/L||Standard Error|Least Squares Mean
757053|NCT00605475|Secondary|Mean Change From Baseline in Plasma Insulin AUC ( Area Under the Curve) 0-4 Hours, Following Oral Glucose Tolerance Test ( OGTT )|Blood samples were drawn after an overnight fast and OGTT at 0, 15, 30, 45, 60, 90, 120, 180 and 240 min. Insulin levels over 4 hrs were shown as Area Under the Curve, (AUC). Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.|Baseline, Day 28, Day 84|All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.||µIU*h/mL||Standard Error|Least Squares Mean
757054|NCT00605475|Primary|Mean Change From Baseline in Plasma HbA1c (Glycosylated Hemoglobin / Hemoglobin A1c)|Blood was drawn after an overnight fast to measure plasma HbA1c levels. End of Study is defined as the last Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.|Baseline, Day 28, Day 84, Day 126, End of Study (168 [+/- 5] days after dosing)|All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.||percent||Standard Error|Least Squares Mean
757055|NCT00605475|Secondary|Mean Change From Baseline in Plasma C-peptide AUC ( Area Under the Curve) 0-4 Hours, Following Oral Glucose Tolerance Test (OGTT)|Blood samples were drawn after an overnight fast and standard OGTT at 0, 15, 30, 45, 60, 90, 120, 180 and 240 min. C-peptide levels over 4 hrs were shown as Area Under the Curve, (AUC). Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.|Baseline, Day 28, Day 84|All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.||pmol*h/L||Standard Error|Least Squares Mean
757056|NCT00605540|Primary|Health Status|Saint George’s Respiratory Questionnaire (SGRQ)was used to evaluate patient's health status. SGRQ includes three domains: symptoms, activities and impact of the disease. Each domain has a minimum score (zero) and maximum (662.5, 1209.1, and 2117.8, respectively). A total score is also calculated based on the results of three domains, with a score maximum of 3989.4. The total score is referred to as the percentage achieved by the patient related to this maximum score. Minimum score means there is no impairment in the health status and high score means maximum dysfunction.|Baseline and after three years|||Percentage of total score||Standard Deviation|Mean
757057|NCT00605540|Primary|Dyspnea|Dyspnea was evaluated by Medical Research Council scale (MRC). MRC scale consists of only five items and it is based on activities that cause dyspnea. The patient reports the degree of dyspnea by choosing a value between 1 and 5. A higher number indicates greater sensation of dyspnea.|Baseline and after three years|||Scores on a scale||Inter-Quartile Range|Median
757058|NCT00605540|Primary|Body Composition|Body composition was evaluated by Body Mass Index (BMI), which is dividing weight in kilograms by height in square meters.|Baseline and after three years|||Kg/m^2||Inter-Quartile Range|Median
757059|NCT00605540|Primary|Exercise Tolerance|Tolerance exercise was evaluated by six-minute walking distance(6MWD)according to the American Thoracic Society guidelines.Patients were instructed to walk, attempting to cover as much ground as possible within 6 min. A research assistant timed the walk, and standardized verbal encouragement was given.|Baseline and after three years|||meters||Standard Deviation|Mean
757060|NCT00605540|Primary|Forced Expiratory Volume in the First Second (FEV1)|FEV1 values were measured by Spirometry using the KOKO Spirometer, before and 15 minutes after the inhalation of 400mcg of salbutamol.|Baseline and after three years|The sampling frame for this study was consecutive COPD patients recruited from the outpatient clinic of Botucatu Medical School.||Percentage predicted||Inter-Quartile Range|Median
757061|NCT00605657|Secondary|To Determine Whether the Treatment Alters, in Favorable Directions, Laboratory Markers of ALPS (e.g., Number of DNT Cells, Immunoglobin Levels, Vitamin B12 Levels, IL-10 Levels, Autoantibody Titers, Fas Mediated Apoptosis)||3 monthly (12 week) intervals|outcome measure not assessed because 0 participants had a response|||||
757144|NCT00589121|Other Pre-specified|Comparison of SAQ Scores at 2 Years for Cohort A Patients With Cohort B Patients||2 years after start of treatment (+/- 3 months)||||||
757063|NCT00605696|Secondary|Murray Lung Injury Score|Murray Lung Injury Score is a continuous score that quantifies the severity of lung injury and consist of components related to severity of hypoxia, pulmonary compliance, peep, and radiologic abnormalities. The scores range between 0 - 4. The higher the score, the greater the degree and severity of lung injury. The scale runs from 0-4, with 0 being the minimum and 4 the maximum score.|Measured at Day 3|Change in Murray Lung Injury score from Day 3 to Day 0 (baseline)||units on a scale||Standard Deviation|Mean
757064|NCT00605696|Primary|Plasma Levels of Free Fatty Acids, Tumor Necrosis Factor-α, Interleukin-6, and Von Willebrand Factor Antigen||Measured at Day 1, 3 and 7|Although blood samples were collected, there were no bioassays perfomed and therefore no data were collected from any study participants.|||||
757065|NCT00605722|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events. A SAE was any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.|Up to 107 Weeks|Safety population included all participants who received at least one dose of study drug.||participants|||Number
757066|NCT00605722|Secondary|Overall Survival (OS)|OS was defined as the time period in months from the start of study drug treatment to death.|Event driven (median follow-up 12 months)|Intent-to-treat population included all participants who received study drug.||months||95% Confidence Interval|Median
757067|NCT00605722|Secondary|Progression-free Survival (PFS)|PFS was defined as the time period in months from the start of study drug treatment to the first of either progression or death. Progressive disease required at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Event driven (median follow-up 12 months)|Intent-to-treat population included all participants who received study drug. Participants were censored at the last follow-up visit.||months||95% Confidence Interval|Median
757068|NCT00605722|Secondary|Time to Tumor Progression|Time to tumor progression was defined as the time period in months from the start of study drug treatment to disease progression. Progressive disease required at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Event driven (median follow-up 12 months)|Intent-to-treat population included all participants who received study drug.||Months||95% Confidence Interval|Median
757069|NCT00605722|Secondary|Disease Control Rate (DCR)|Disease Control Rate was defined as the percentage of participants with Complete Response (CR), Partial Response (PR) or Stable Disease (SD) for at least 8 weeks by Response Evaluation Criteria in Solid Tumours (RECIST). CR was defined as the disappearance of all target lesions; for non-target lesions disappearance of lesions and normal tumour marker levels. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using as reference the Baseline sum LD. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started; for non-target lesions persistence of one or more non-target lesion(s) and/or maintenance of tumour marker level above the normal limits.|Event driven (median follow-up 12 months)|Intent-to-treat population included all participants who received study drug.||Percentage of participants||95% Confidence Interval|Number
757070|NCT00605722|Secondary|Overall Response Rate (ORR)|ORR was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR). Analysis of tumor response was based on the best overall response according to Response Evaluation Criteria in Solid Tumors (RECIST), which was defined as the best response recorded from the start of trial treatment until disease progression/recurrence (or death), taking as reference for progressive disease (PD) the smallest measurements recorded since the treatment started. CR was defined as the disappearance of all target lesions; for non-target lesions disappearance of lesions and normal tumour marker levels. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using as reference the Baseline sum LD. PD required at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Event driven (median follow-up 12 months)|Intent-to-treat population included all participants who received study drug.||percentage of participants||95% Confidence Interval|Number
757071|NCT00605722|Primary|Percentage of Participants With Progression-free Survival (PFS)|Percentage of participants who were alive and without documented progressive disease 16 weeks after their first dose of study drug. Diagnosis of Progressive Disease was made by objective criteria (RECIST criteria) on the target lesion(s), or by documenting, with Computerised Tomography/Magnetic Resonance Imaging (CT/MRI) scans, the presence of newly occurring lesion(s) arising outside the scanned areas of the target lesions. PD required at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Week 16|Intent-to-treat population included all participants who received study drug. Participants who had neither progressed nor died at the time of study completion or who were lost to follow-up were censored at the date of the last tumor assessment or last follow up for progression of disease.||percentage of participants||95% Confidence Interval|Number
757072|NCT00605813|Secondary|Factors Considered to Affect the Efficacy of Sertraline: Present or Past History of Intentional Suicidal Ideation (Including Suicide Attempt)|Number of participants with responders of Sertraline to determine whether present or past history of intentional suicidal ideation (including suicide attempt) is significant factor|Baseline up to 52 weeks|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
757073|NCT00605813|Secondary|Factors Considered to Affect the Efficacy of Sertraline: Non-Pharmaceutical Therapies|Number of participants with responders of Sertraline to determine whether with or without non-pharmaceutical therapies is significant factor|Baseline up to 52 weeks|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
757074|NCT00605813|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Past Medical History of Other Illness|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertralinedine to determine whether with or without past medical history of other illness is significant risk factor|Baseline up to 52 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed.||participants|||Number
757075|NCT00605813|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Renal Dysfunction|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertralinedine to determine whether with or without renal dysfunction is significant risk factor|Baseline up to 52 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed.||participants|||Number
757076|NCT00605813|Primary|Number of Participants of Treatment Related Adverse Events (TRAEs)|All observed or volunteered adverse events and the investigator’s opinion of the causal relationship to the study treatment were reported. Definition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product.|Baseline up to 52 weeks|Safety analysis population included all enrolled subjects who had received at least 1 confirmed, administration of Sertraline.||events|||Number
757077|NCT00605813|Primary|Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert||Baseline up to 52 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed.||events|||Number
757082|NCT00605865|Secondary|Factors Considered to Affect the Efficacy of Sertraline: Suicidal Ideation (Including Suicide Attempt)|Number of participants with responders of Sertraline to determine whether with or without suicidal ideation (including suicide attempt) is significant factor|Baseline up to 16 weeks|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
757083|NCT00605865|Secondary|Factors Considered to Affect the Efficacy of Sertraline: Age|Number of participants with responders of Sertraline to determine whether age is significant factor|Baseline up to 16 weeks|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
757084|NCT00605865|Secondary|Factors Considered to Affect the Efficacy of Sertraline: 15 Years and Higher of Age or Not|Number of participants with responders of Sertraline to determine whether 15 years and higher of age or not is significant factor|Baseline up to 16 weeks|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
757085|NCT00605865|Secondary|Factors Considered to Affect the Efficacy of Sertraline: Complication ;Complications is the Patient's Current Experiences With Illnesses, Operations, Injuries and Treatments.|Number of participants with responders of Sertraline to determine whether with or without complication is significant factor|Baseline up to 16 weeks|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
757086|NCT00605865|Secondary|Factors Considered to Affect the Efficacy of Sertraline: Outpatient/Inpatient|Number of participants with responders of Sertraline to determine whether outpatient or inpatient is significant factor|Baseline up to 16 weeks|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
757087|NCT00605865|Secondary|Factors Considered to Affect the Efficacy of Sertraline: History of Treatment Prior to Administration of Sertraline Hydrochloride|Number of participants with responders of Sertraline to determine whether with or without history of treatment prior to administration of Sertraline hydrochloride is significant factor|Baseline up to 16 weeks|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
757088|NCT00605865|Secondary|Factors Considered to Affect the Efficacy of Sertraline: Target Disease Severity|Number of participants with responders of Sertraline to determine whether target disease severity is significant factor|Baseline up to 16 weeks|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
757089|NCT00605865|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: 15 Years and Higher of Age or Not|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether 15 years and higher of age or not is significant risk factor|Baseline up to 16 weeks|The safety analysis population consists of the cases that satisfy the participant's conditions and in whom administration of Sertraline was confirmed.||participants|||Number
757090|NCT00605865|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Suicidal Ideation (Including Suicide Attempt)|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without suicidal ideation (including suicide attempt) is significant risk factor|Baseline up to 16 weeks|The safety analysis population consists of the cases that satisfy the participant's conditions and in whom administration of Sertraline was confirmed.||participants|||Number
757091|NCT00605865|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Average Daily Dose|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether average daily dose is significant risk factor|Baseline up to 16 weeks|The safety analysis population consists of the cases that satisfy the participant's conditions and in whom administration of Sertraline was confirmed.||participants|||Number
757092|NCT00605865|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Past Medical History of Other Illness|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without Past Medical History of Other Illness is significant risk factor|Baseline up to 16 weeks|The safety analysis population consists of the cases that satisfy the participant's conditions and in whom administration of Sertraline was confirmed.||participants|||Number
757093|NCT00605865|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Renal Dysfunction|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without renal dysfunction is significant risk factor|Baseline up to 16 weeks|The safety analysis population consists of the cases that satisfy the participant's conditions and in whom administration of Sertraline was confirmed.||participants|||Number
757094|NCT00605865|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Concomitant Drug|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without concomitant drug is significant risk factor, Concomitant drugs is the drugs which participant had taken during the observation period of this study to treat for participant's illnesses, injuries etc. The physician of this survey listed all of concomitant drugs. (e.g. paroxetine, milnacipran, etc.)|Baseline up to 16 weeks|The safety analysis population consists of the cases that satisfy the participant's conditions and in whom administration of Sertraline was confirmed.||participants|||Number
757095|NCT00605865|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Complications|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without complications is significant risk factor, Complications is the patient's current experiences with illnesses, operations, injuries and treatments. The physician of this survey made the diagnosis. (e.g. hypertension, diabetes, etc.)|Baseline up to 16 weeks|The safety analysis population consists of the cases that satisfy the participant's conditions and in whom administration of Sertraline was confirmed.||participants|||Number
757096|NCT00605865|Primary|Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert||Baseline up to 16 weeks|The safety analysis population consists of the cases that satisfy the participant's conditions and in whom administration of Sertraline was confirmed.||events|||Number
757097|NCT00605865|Primary|Number of Participants of Treatment Related Adverse Events (TRAEs)|All observed or volunteered adverse events and the investigator’s opinion of the causal relationship to the study treatment were reported. Definition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product.|Baseline up to 16 weeks|Safety analysis population included all enrolled participants who had received at least 1 confirmed administration of Sertraline.||participants|||Number
757098|NCT00605904|Primary|Alcohol Craving Rating in Response to Yohimbine Infusion|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). It is a 5-item self-administered instrument that measures frequency, intensity, and duration of thoughts about drinking, along with ability to resist drinking. There is a single outcome score than ranges from 0 to 30, with 30 being the maximum amount of alcohol craving.|180 minutes after the start of the infusion|The analyses included only those subjects who completed all three types of infusions (saline, meta-Chlorophenylpiperazine, and yohimbine)||Units on a scale||Standard Error|Mean
757099|NCT00605904|Primary|Alcohol Craving Rating in Response to Meta-Chlorophenylpiperazine|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). It is a 5-item self-administered instrument that measures frequency, intensity, and duration of thoughts about drinking, along with ability to resist drinking. There is a single outcome score than ranges from 0 to 30, with 30 being the maximum amount of alcohol craving.|180 minutes after the start of the infusion|The analyses included only those subjects who completed all three types of infusions (saline, meta-Chlorophenylpiperazine, and yohimbine)||Units on a scale||Standard Error|Mean
757100|NCT00605904|Primary|Alcohol Craving Rating in Response to Saline Infusion|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). It is a 5-item self-administered instrument that measures frequency, intensity, and duration of thoughts about drinking, along with ability to resist drinking. There is a single outcome score than ranges from 0 to 30, with 30 being the maximum amount of alcohol craving.|180 minutes after the start of the infusion|The analyses included only those subjects who completed all three types of infusions (saline, meta-Chlorophenylpiperazine, and yohimbine)||Units on a scale||Standard Error|Mean
757101|NCT00605917|Secondary|Factors Considered to Affect the Efficacy of Sertraline: Drinking Status|Number of participants with responders of Sertraline to determine whether drinking status is significant factor|Baseline up to 52 weeks|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
757102|NCT00605917|Secondary|Factors Considered to Affect the Efficacy of Sertraline: Complication|Number of participants with responders of Sertraline to determine whether with or without complication is significant factor, Complications is the patient's current experiences with illnesses, operations, injuries and treatments. The physician of this survey made the diagnosis. (e.g. hypertension, diabetes, etc.)|Baseline up to 52 weeks|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
757103|NCT00605917|Secondary|Factors Considered to Affect the Efficacy of Sertraline: Concomitant Drug|Number of participants with responders of Sertraline to determine whether with or without concomitant drug is significant factor|Baseline up to 52 weeks|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
757145|NCT00589121|Other Pre-specified|Comparison of TESS and the MSTS Scores at 2 Years Between Cohort B Patients and the Preoperative Radiotherapy Patients in the NCIC CTG Trial [National Cancer Institute of Canada Clinical Trials Group]||2 years after start of treatment (+/- 3 months)||||||
757104|NCT00605917|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Complications|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without complications is significant risk factor, Complications is the patient's current experiences with illnesses, operations, injuries and treatments. The physician of this survey made the diagnosis. (e.g. hypertension, diabetes, etc.)|Baseline up to 52 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed.||participants|||Number
757105|NCT00605917|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Average Daily Dose|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without average daily dose is significant risk factor|Baseline up to 52 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed.||participants|||Number
757106|NCT00605917|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: History of Treatment Prior to Administration of Sertraline|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without history of treatment prior to administration of Sertraline is significant risk factor|Baseline up to 52 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed.||participants|||Number
757107|NCT00605917|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Non-Pharmaceutical Therapies|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without non-pharmaceutical therapies is significant risk factor|Baseline up to 52 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of was confirmed.||participants|||Number
757108|NCT00605917|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Past Medical History of Other Illness|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without past medical history of other illness is significant risk factor|Baseline up to 52 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed.||participants|||Number
757109|NCT00605917|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Smoking Status|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether smoking status is significant risk factor|Baseline up to 52 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed.||participants|||Number
757110|NCT00605917|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Family History of Psychiatric Disorder|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without family history of psychiatric disorder is significant risk factor|Baseline up to 52 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed.||participants|||Number
757111|NCT00605917|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Concomitant Drug|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without concomitant drug is significant risk factor, Concomitant drugs is the drugs which participant had taken during the observation period of this study to treat for participant's illnesses, injuries etc. The physician of this survey listed all of concomitant drugs. (e.g. paroxetine, milnacipran, etc.)|Baseline up to 52 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed.||participants|||Number
757112|NCT00605917|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Starting Dose|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether starting dose is significant risk factor|Baseline up to 52 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed.||participants|||Number
757113|NCT00605917|Primary|Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert||Baseline up to 52 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed.||events|||Number
757114|NCT00605917|Primary|Number of Participants of Treatment Related Adverse Events (TRAEs)|All observed or volunteered adverse events and the investigator’s opinion of the causal relationship to the study treatment were reported. Definition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product.|Baseline up to 52 weeks|Safety analysis population included all enrolled participants who had received at least 1 confirmed administration of Sertraline.||participants|||Number
757115|NCT00606008|Secondary|Number of Participants With Related Grade 3 and Greater Adverse Events|To evaluate toxicities associated with sunitinib treatment (grade 3 and greater toxicities).|12 Months|All participants||Participants|||Number
757116|NCT00606008|Secondary|Best Overall Response|To estimate best response rates (proportion of patients who ever had a radiographic response equal to or better than stable disease during course assessment).|12 Months|All participants||Participants|||Number
757117|NCT00606008|Primary|Number of Participants With Progression Free Survival (PFS) at 6 Months Utilizing McDonald Criteria for Response, Progression and Relapse|Complete Response: Disappearance of all lesions, disease signs and symptoms related to the tumor. Partial Response (PR): When compared with pretreatment measurements, a reduction of 50% decrease in the sum of the longest diameters of all target enhancing lesions, taking as reference the baseline sum of the longest diameter. Stable Disease: Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum of the longest diameter since treatment started. Objective Progression or Relapse: Relative to pretreatment measurements, an increase in the sum of the diameters of any measured enhancing lesion by at least 25% increase in the sum of the longest diameters since the treatment started or the appearance of new enhancing lesions.|6 Months|All participants||Participants|||Number
757118|NCT00606021|Secondary|Tumor Response Rate and Disease Control Rate After Induction Phase (IP)|Tumor response rate (%) is the number of responders (participants with best response of CR or PR) divided by the number of participants qualified for tumor response according to RECIST criteria multiplied by 100. Disease control rate is percentage of participants with a best response of stable disease [SD], PR, or CR. CR=disappearance of all target lesions; PR=30% decrease in sum of longest diameter of target lesions; PD is≥20% increase in sum of longest diameter of target lesions. SD= neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|Randomization to measured PD up to 31.4 months|Participants who were randomized into maintenance phase and had measurable or evaluable lesions at baseline (last assessment before randomization) and post-baseline.||percentage of participants||95% Confidence Interval|Number
757119|NCT00606021|Secondary|Number of Participants With Adverse Events (AEs) During Overall Period|The list of serious adverse events (SAEs) and other non-serious adverse events (AEs) are in Adverse Events Section.|First dose of study drug during IP through overall study completion (up to 34.3) months|Participants who took at least one dose of study drug during IP, and randomized to maintenance phase.||participants|||Number
757120|NCT00606021|Secondary|Overall Survival During Overall Period (IP + MP)|Overall survival in overall period is defined as the time from first dose of study drug during IP to death. Participants who were alive were censored at the last contact.|First dose of study drug during IP to PD or date of death from any cause up to 34.1 months|Participants who took at least one dose of study drug during IP and had measurable or evaluable lesions at baseline (assessment before induction phase) and post baseline.||months||95% Confidence Interval|Median
757121|NCT00606021|Secondary|Overall Survival During Maintenance Phase|Overall survival in maintenance phase is defined as the time from randomization to death. Participants who were alive were censored at the last contact.|Randomization to PD or date of death from any cause up to 31.3 months|Participants who were randomized into maintenance phase and had measurable or evaluable lesions at baseline (last assessment before randomization) and post-baseline.||months||95% Confidence Interval|Median
757122|NCT00606021|Secondary|Progression Free Survival During Overall Period (Induction Phase [IP] + Maintenance Phase [MP])|Progression-free survival in overall period is defined as the time from the date of first dose of study drug during IP until the date of PD or death from any cause. PD was determined using RECIST criteria. PD is ≥20% increase in sum of longest diameter of target lesions. PD in overall period uses the screening lesion assessment prior to the induction phase as the baseline assessment.|First dose of study drug during IP to PD or date of death from any cause up to 33.6 months|Participants who took at least one dose of study drug during IP and had measurable or evaluable lesions at baseline (assessment before induction phase) and post baseline.||months||95% Confidence Interval|Median
757123|NCT00606021|Primary|Progression Free Survival During Maintenance Phase|Progression free survival is defined as the time from randomization until the date of progression of disease (PD) or death from any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD is ≥20% increase in sum of longest diameter of target lesions. PD in maintenance phase uses the last lesion assessment prior to randomization as the baseline assessment.|Randomization to progression of disease (PD) or date of death from any cause up to 30.9 months|Participants who were randomized into maintenance phase and had measurable or evaluable lesions at baseline (last assessment before randomization) and post-baseline.||months||95% Confidence Interval|Median
757124|NCT00606034|Secondary|Patient Satisfaction With Insulin Delivery Method Via Insulin Delivery Rating System Questionnaire (IDRSQ)|Overall satisfaction rated on a scale of 0-100 percent with higher numbers indicating greater satisfaction with the insulin delivery method.|Baseline versus 1 year|per protocol||percent satisfaction||Standard Deviation|Mean
757125|NCT00606034|Secondary|Percentage of Time Spent in Hypoglycemia|For the purposed of this study, hypoglycemia is defined as a blood glucose measurement of less than 70 mg/dl. As part of of this study, subjects will wear a Continuous Glucose Monitor (CGM) for 72 hours to assess glycemic control. The percent of time in hypoglycemia is a part of the download from the CGM.|baseline versus 12 months|ITT (LOCF for 1 subject)||percent of time spent in hypoglycemia||Standard Deviation|Mean
757126|NCT00606034|Primary|Improvement in Glycemic Control as Assessed by Change in Hemoglobin A1c (HbA1c)|HbA1c is expressed as a percentage. This measurement represents an average of plasma glucose concentration for about 3 months. We will report the change in HbA1c measured at 12 months vs Baseline.|1 year|Per Protocol||HbA1c percentage||Standard Deviation|Mean
757127|NCT00606086|Primary|EVR (Early Virologic Response)|Early Virologic Response (EVR) is a response measured by the reduction of virus in the blood after 12 weeks of treatment.|At 12 weeks of treatment|One hundred forty subjects were randomized, only 133 subjects received at least one dose of study drug. Subjects who did not receive at least one dose of study drug were removed from the analysis.||percentage of participants|||Number
757128|NCT00606138|Secondary|Occurrence Rate of Proliferative Diabetic Complications Including Vitreous Hemorrhage, Iris Neovascularization, and Tractional Retinal Detachment||Month 6|||number of PDR complications|||Number
757129|NCT00606138|Secondary|Percentage of Patients Gaining 3 or More Lines of Vision According to ETDRS Eye Chart Testing||Week 1, 2, 4; Month 2, 3, 4, 5, 6||||||
757130|NCT00606138|Secondary|Mean Change in Best Corrected Visual Acuity (BCVA), as Assessed by the Number of Letters Read Correctly on the ETDRS Eye Chart at a Starting Test Distance of 4 Meters||Week 4; Month 6|||lines of vision gained||Standard Deviation|Mean
757131|NCT00606138|Primary|Incidence and Severity of Other Adverse Events, as Identified by Physical Examination, Subject Reporting, and Changes in Vital Signs||Week 1, 2, 4; Month 2, 3, 4, 5, 6||||||
757132|NCT00606138|Primary|Incidence and Severity of Ocular Adverse Events, as Identified by Ophthalmic Examination||Month 6|||number of events|||Number
757133|NCT00606138|Primary|The Mean Percentage Change of Macular Edema Measured by Retinal Thickness by OCT (Optical Coherence Tomography)||Week 4; Month 6|||percentage of change (mean)||Standard Deviation|Mean
757134|NCT00606138|Primary|The Mean Percentage Change of the Area of the Patient's Neovascularization as Measured in Pixels by Optomap FA (Fluorescein Angiography)|This is a measurement of how much change in neovascularization has occurred, using the Optomap FA readings to calculate the increase or decrease in surface area of the retina that is affected by neovascularization.|Week 4; Month 6|||percentage of change in area (mean)||Standard Deviation|Mean
757135|NCT00606177|Secondary|Clinical Global Impression - Bipolar Version (CGI-BP) Severity of Illness (Mania)|"Using LOCF datasets, descriptive statistics of actual values for change of CGI-BP severity of illness score (mania) from baseline (Day 1 of preceding study) to endpoint (Day 154) were calculated for each treatment group.
CGI-BP severity of illness is a scale for overall evaluation of the severity of bipolar disorder; it comprises 3 components—mania, depression, and overall bipolar illness.
CGI-BP severity of illness score (mania) ranges form 1 (normal, not ill) to 7 (very severely ill)."|Baseline (Day 1 of preceding study), Day 154 or at discontinuation|FAS: The FAS consisted of subjects who had received at least one dose of investigational product and for whom the post-dosing efficacy parameter data had been obtained. Cases of GCP violation were excluded from analysis.||scores on scale||Standard Deviation|Mean
757136|NCT00606177|Primary|Young Mania Rating Scale (YMRS)|"Using LOCF datasets, descriptive statistics of actual values for changes of YMRS total scores from baseline (Day 1 of preceding study) to endpoint (Day 154) was calculated for each treatment group.
YMRS is composed of 11 evaluation items with 5 rating levels each. Items rated on a scale of 0 to 4 (comprising 5 rating levels of one point each) are 1) levated mood, 2) increased motor activity/energy, 3) sexual interest, 4) sleep, 7) language-thought disorder, 10) appearance, and 11) insight. Items rated on a scale of 0 to 8 (comprising 5 rating levels of two points each) are 5) irritability, 6) speech (rate and amount), 8) content, and 9) disruptive-aggressive behavior.
YMRS ranges from 0 (best possible outcome) to 60 (worst possible outcome)."|Baseline (Day 1 of preceding study) , Day 154 or at discontinuation|FAS: The FAS consisted of subjects who had received at least one dose of investigational product and for whom the post-dosing efficacy parameter data had been obtained. Cases of GCP violation were excluded from analysis.||scores on a scale||Standard Deviation|Mean
757137|NCT00606229|Secondary|Clinical Global Impression - Bipolar Version (CGI-BP) Sevirity of Illness Score (Mania)|"Mean change from baseline (Day 1) to endpoint in Clinical Global Impression -Bipolar Version (CGI-BP) severity of illness score (mania)
The severity of manic symptoms on a scale of 1 (normal, not ill) to 7 (very severely ill)"|Day 1 and Daty 168 or time of discontinuation|Results obtained from the LOCF dataset of 40 subjects of the Full Analysis Set (FAS) (excluding 1 subject whose post-dose data of efficacy endpoint were not available from the 41 treated subjects)||scores on a scale||Standard Deviation|Mean
757138|NCT00606229|Primary|Young Mania Rating Scale (YMRS)|"Mean change from baseline (Day 1) to endpoint in the YMRS total score
YMRS is composed of 11 evaluation items with 5 rating levels each. Items rated on a scale of 0 to 4 (comprising 5 rating levels of one point each) are 1) elevated mood, 2) increased motor activity/energy, 3) sexual interest, 4) sleep, 7) language-thought disorder, 10) appearance, and 11) insight. Items rated on a scale of 0 to 8 (comprising 5 rating levels of two points each) are 5) irritability, 6) speech (rate and amount), 8) content, and 9) disruptive-aggressive behavior.
Total score range is 0 to 60, and the higher value represents worsen."|Day 1 and Day 168 or time of discontinuation|Results obtained from the LOCF dataset of 40 subjects of the Full Analysis Set (FAS) (excluding 1 subject whose post-dose data of efficacy endpoint were not available from the 41 treated subjects)||scores on a scale||Standard Deviation|Mean
757139|NCT00606281|Secondary|Clinical Global Impression - Bipolar Version (CGI-BP), Severity of Illness Score (Mania)|"CGI-BP severity of illness is a scale for overall evaluation of the severity of bipolar disorder; it comprises 3 components—mania, depression, and overall bipolar illness.
CGI-BP severity of illness score (mania) ranges form 1 (normal, not ill) to 7 (very severely ill).
Using LOCF datasets, change in CGI-BP severity of illness score (mania) from baseline (Day 1) to endpoint (Day 21) was evaluated through ANCOVA."|Day1, Day21|FAS: The FAS consisted of subjects who had received at least one dose of investigational product and for whom the post-dosing efficacy parameter data had been obtained. Cases of GCP violation were excluded from analysis.||scores on a scale||Standard Error|Least Squares Mean
757140|NCT00606281|Primary|Young Mania Rating Scale (YMRS)|"Using LOCF datasets, change in YMRS total score from baseline (Day 1) to endpoint (Day 21) was evaluated through analysis of covariance(ANCOVA).
YMRS is composed of 11 evaluation items with 5 rating levels each. Items rated on a scale of 0 to 4 (comprising 5 rating levels of one point each) are 1) elevated mood, 2) increased motor activity/energy, 3) sexual interest, 4) sleep, 7) language-thought disorder, 10) appearance, and 11) insight. Items rated on a scale of 0 to 8 (comprising 5 rating levels of two points each) are 5) irritability, 6) speech (rate and amount), 8) content, and 9) disruptive-aggressive behavior.
YMRS ranges from 0 (best possible outcome) to 60 (worst possible outcome)."|Day1, Day21|Full analysis set (FAS): The FAS consisted of subjects who had received at least one dose of investigational product and for whom the post-dosing efficacy parameter data had been obtained. Cases of GCP violation were excluded from analysis.||scores on a scale||Standard Error|Least Squares Mean
757141|NCT00606320|Secondary|Clinical Global Impression - Bipolar Version (CGI-BP) Severity of Illness (Mania)|"CGI-BP severity of illness is a scale for overall evaluation of the severity of bipolar disorder; it comprises 3 components—mania, depression, and overall bipolar illness. CGI-BP severity of illness score (mania) ranges form 1 (normal, not ill) to 7 (very severely ill).
Using LOCF datasets, descriptive statistics of actual values for change of CGI-BP severity of illness score (mania) from baseline (Day 1 of preceding study) to endpoint (Day 154) was calculated for each treatment group."|Baseline (Day 1 of preceding study) , Day 154 or at discontinuation|||scores on a scale||Standard Deviation|Mean
757142|NCT00606320|Primary|Young Mania Rating Scale (YMRS)|YMRS is composed of 11 evaluation items with 5 rating levels each. Items rated on a scale of 0 to 4 (comprising 5 rating levels of one point each) are 1) levated mood, 2) increased motor activity/energy, 3) sexual interest, 4) sleep, 7) language-thought disorder, 10) appearance, and 11) insight. Items rated on a scale of 0 to 8 (comprising 5 rating levels of two points each) are 5) irritability, 6) speech (rate and amount), 8) content, and 9) disruptive-aggressive behavior. YMRS ranges from 0 (best possible outcome) to 60 (worst possible outcome). Using LOCF datasets, descriptive statistics of actual values for changes of YMRS total scores from baseline (Day 1 of preceding study) to endpoint (Day 154) was calculated.|baseline (Day 1 of preceding study), Day 154 or at discontinuation|||scores on a scale||Standard Deviation|Mean
757143|NCT00606489|Primary|Temperature|Area under the curve temperature from baseline to hour 24 following initiation of treatment.|0 to 24 hours|Efficacy analyses were performed on the Intent to Treat (ITT) population and the Efficacy Evaluable Population (EEP). All randomized patients who received at least a partial dose of CTM were included in the ITT analyses. All data below represents the ITT analyses.||Degree Celcius times hours (AUC-T)||Standard Error|Least Squares Mean
757147|NCT00589121|Secondary|Percentage of Patients With Other CTCAE, v.3.0 Grade 3-5 Adverse Events|Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.|From start of treatment to last follow-up. Analysis can occur at or after time of primary outcome measure analysis.|All eligible patients on Cohort B who started study treatment. (See limitations and caveats, Cohort A is not included.)||percentage of patients||95% Confidence Interval|Number
757148|NCT00589121|Secondary|Impact of Late Radiation Morbidity (≥ Grade 2 Lymphedema, Subcutaneous Fibrosis, or Joint Stiffness) at 2 Years on the Clinical Measure, Musculoskeletal Tumor Rating Scale (MSTS)||2 years after start of treatment (+/- 3 months)||||||
757149|NCT00589121|Secondary|Pattern of First Failure|Pattern of first failure including local failure (in-field, marginal, and outside-field failure), regional failure, distant failure, and death without disease progression.|From registration to date of local, regional or distant progression. Report at time of primary outcome measure analysis.|All eligible patients on Cohort B who started study treatment. All eligible patients on Cohort B. (See limitations and caveats, Cohort A is not included.)||participants|||Number
757150|NCT00589121|Secondary|Percentage of Patients With Wound Complications|Estimate rate of patients with acute wound complications with 95% confidence interval assuming binomial distribution.|From date of surgery to 4 months post-surgery|All eligible patients on cohort B that had surgery and a wound assessment. (See limitations and caveats, Cohort A is not included.)||percentage of participants||95% Confidence Interval|Number
757151|NCT00589121|Secondary|Late Radiation Morbidity Rate (≥ Grade 2 Lymphedema, Subcutaneous Fibrosis or Joint Stiffness) at 2 Years From the Start of Radiotherapy as Measured by CTCAE v3.0|Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.|2 years after start of treatment (+/- 3 months)|All eligible patients on Cohort B who started study treatment and had an assessment of toxicity at 2 years. (See limitations and caveats, Cohort A is not included.)||percentage of participants||95% Confidence Interval|Number
757152|NCT00589121|Secondary|Second Primary Tumor Rate at Two Years|Second primary tumor is defined as the time from registration to date of failure (second primary tumor) or death or last follow-up. Two year rate and 95% confidence interval were estimated by the cumulative incidence method.|From registration to date of failure (second primary tumor) or death or last follow-up. Report at time of primary outcome measure analysis.|All eligible patients on Cohort B who started study treatment. (See limitations and caveats, Cohort A is not included.)||percentage of participants||95% Confidence Interval|Number
757153|NCT00589121|Secondary|Overall Survival Rate at Two Years|Overall survival is defined as the time from registration to date of death or last follow-up. Two year survival rate and 95% confidence interval were estimated by the Kaplan-Meier method.|From registration to date of death or last follow-up. Report at time of primary outcome measure analysis.|All eligible patients on Cohort B who started study treatment. (See limitations and caveats, Cohort A is not included.)||percentage of participants||95% Confidence Interval|Number
757154|NCT00589121|Secondary|Disease-free Survival Rate at Two Years|Disease-free survival is defined as the time from registration to date of failure (local, regional, or distant progression or death) or last follow-up. Two year rate and 95% confidence interval were estimated by the Kaplan-Meier method.|From registration to date of failure (local, regional or distant progression or death) or last follow-up. Report at time of primary outcome measure analysis.|All eligible patients on Cohort B who started study treatment. (See limitations and caveats, Cohort A is not included.)||percentage of participants||95% Confidence Interval|Number
757155|NCT00589121|Secondary|Distant Disease-free Survival Rate at Two Years|Distant disease-free survival is defined as the time from registration to date of failure (distant progression or death) or last follow-up. Two year rate and 95% confidence interval were estimated by the Kaplan-Meier method.|From registration to date of failure (distant progression or death) or last follow-up. Report at time of primary outcome measure analysis.|All eligible patients on Cohort B who started study treatment. (See limitations and caveats, Cohort A is not included.)||percentage of participants||95% Confidence Interval|Number
757156|NCT00589121|Secondary|Distant Failure Rate at Two Years|Distant failure is defined as the time from registration to date of failure (distant progression) or death or last follow-up. Two year rate and 95% confidence interval were estimated by the cumulative incidence method.|From registration to date of failure (distant progression) or death or last follow-up. Report at time of primary outcome measure analysis.|All eligible patients on Cohort B who started study treatment. (See limitations and caveats, Cohort A is not included.)||percentage of participants||95% Confidence Interval|Number
757157|NCT00589121|Secondary|Regional Failure Rate at Two Years|Regional failure is defined as the time from registration to date of failure (regional progression) or death or last follow-up. Two year rate and 95% confidence interval were estimated by the cumulative incidence method.|From registration to date of failure (regional progression) or death or last follow-up. Report at time of primary outcome measure analysis.|All eligible patients on Cohort B who started study treatment. (See limitations and caveats, Cohort A is not included.)||percentage of participants||95% Confidence Interval|Number
757158|NCT00589121|Secondary|Local Failure Rate at Two Years|Local failure is defined as the time from registration to date of failure (local progression) or death or last follow-up. Two year rate and 95% confidence interval were estimated by the cumulative incidence method.|From registration to date of failure (local progression) or death or last follow-up. Report at time of primary outcome measure analysis.|All eligible patients on Cohort B who started study treatment. (See limitations and caveats, Cohort A is not included.)||percentage of participants||95% Confidence Interval|Number
757190|NCT00600756|Secondary|The Effect of Quetiapine XR Versus Risperidone Regarding Health Economics Outcomes by Evaluating the Number of Participants Using Other Psychotropic Medications at Month 12 in the ITT Population|Other psychotropic medications include antiepileptics, anti-parkinson drugs, antipsychotics, and antidepressants.|12 months|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.||Participants|||Number
757159|NCT00589121|Primary|Rate of Late Radiation Morbidity (≥ Grade 2 Lymphedema, Subcutaneous Fibrosis, or Joint Stiffness) at 2 Years From the Start of Radiotherapy as Measured by EORTC/RTOG Criteria|The rate of patients with late radiation morbidity (≥ grade 2 lymphedema, subcutaneous fibrosis, or joint stiffness) at 2 years from the start of radiotherapy as measured by EORTC(European Organisation for Research and Treatment of Cancer)/RTOG (Radiation Therapy Oncology Group) criteria. Grade refers to the severity of the morbidity. The RTOG/EORTC Late Radiation Morbidity Scoring Schema assigns Grades 1 through 5 with unique clinical descriptions of severity for each morbidity based on this general guideline: Grade 1 Mild , Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to morbidity.|2 years after start of treatment (+/- 3 months)|All eligible patients on Cohort B who started study treatment and had an assessment of toxicity at 2 years. (See limitations and caveats, Cohort A is not included.)||percentage of participants||95% Confidence Interval|Number
757160|NCT00589277|Secondary|7 Day Abstinence|The number of survey respondents that had abstained from smoking for 7 days at the 3 month follow up.|3 month follow up|Per protocol||participants|||Number
757161|NCT00589277|Secondary|24 Hour Abstinence|The number of survey respondents that had abstained from smoking at the 2 week follow up.|2 week follow up|Per protocol||participants|||Number
757162|NCT00589277|Primary|Quit Attempt|Percentage of those that self reported attempting to quit smoking at the 2 week follow up.|2 week follow up|Per protocol||participants|||Number
757163|NCT00589290|Primary|Chromosomal Gains or Losses in Comparative Genomic Hydridization in Thymoma and Thymic Cancer|Utilize a patients tumor tissue to determine if there is any correlation between chromosomal gains or losses in comparative genomic hybridization in thymoma and thymic carcinomas and clinical outcomes.|46 months|Unpublished data from Dr. Giaccone's lab does not reveal an association between these parameters and outcomes in patients with thymic malignancies. Hence we do not plan to perform analyses for these outcome measures and there is no known negative clinical implications associated with this.|||||
757164|NCT00589290|Secondary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|26 months|||Participants|||Number
757165|NCT00589290|Primary|Number of Participants With a Partial Response|Response is defined by the Response Evaluation Criteria in Solid Tumor (RECIST). Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. For additional details about the RECIST criteria see the protocol Link module.|25.5 months|||Participants|||Number
757166|NCT00589303|Primary|Cardiac Hospitalization Within Six Months of Enrollment|Number of patients who were hospitalized for cardiovascular problems within 6 months of enrollment.|Six months after enrollment|Intent-to-treat||participants|||Number
757167|NCT00594854|Secondary|Number of Participants With Upper Gastro-intestinal Injury Grade 4 as Measured by Lanza (1991) Score|The degree of upper gastrointestinal (UGI) injury as measured by Lanza scores (1991) during treatment with PN 400 and ARTHROTEC® in a high-risk population. The Lanza (1991) score is based on endoscopic obeservations and rating these, with no damage, petecchiae, erosions and ulcers. On the 1991 scale, a Lanza score of 0 represents normal mucosa (no damage), while a score of 4 indicates 6-10 erosions, and a score of 7 indicates an ulcer.|6 months|||participants|||Number
757168|NCT00594854|Primary|Number of Participants With Gastric Ulcer Confirmed by Endoscopy|Number of participants with gastric ulcers confirmed by endoscopy following administration of PN 400 (VIMOVO) or Arthrotec in a high risk population over six months.|6 months|||Participants|||Number
757169|NCT00594854|Secondary|Number of Participants With Duodenal Ulcers Confirmed by Endoscopy|Number of participants with duodenal ulcers confirmed by endoscopy following administration of PN 400 VIMOVO)or Arthrotec in a high risk population|6 months|||participants||95% Confidence Interval|Number
757170|NCT00594880|Secondary|HIV Viral Load < 400 Copies/ml|% of individuals maintaining viral suppression (VL < 400 copies/ml) as compared to the anticipated rate of viral suppression in individuals interrupting ART without interferon (9%)|24 weeks|percent of consenting eligible participants (n=8) with VL < 400 at week 24 of treatment||percentage of eligible participants|||Number
757171|NCT00594880|Secondary|HIV Viral Load < 48 Copies/ml|% of individuals maintaining VL < 48 copies/ml while on pegylated interferon alpha-2a treatment without ART|12 weeks|% of subjects maintaining VL < 48 copies/ml after 12 weeks of treatment||percentage of participants|||Number
757172|NCT00594880|Primary|HIV Viral Load < 400 Copies/ml|% of individuals maintaining viral suppression (VL < 400 copies/ml) as compared to the anticipated rate of viral suppression in individuals interrupting ART without interferon (9%)|12 weeks|excluded 2 withdrawal of consent and 1 lost to follow-up||percentage of participants|||Number
757173|NCT00594906|Primary|Healing of a Fracture From a Low Energy Fall|Callus formation at the fracture site as defined by a CT scan to determine healing (early/beginning callus formation) or healed (complete callus formation)|Measured at 16 weeks|||participants|||Number
757174|NCT00594945|Primary|Number of Spikes and Sharp Waves, Relative Change From Baseline to Treatment Day (%).|Summary of video EEG number of spikes and sharp waves. Over a 24 hour period.|Change from baseline to treatment day|||percentage of baseline||Standard Deviation|Mean
757175|NCT00600613|Primary|"Number of Participants Eligible for Cone Beam Tumor Localization"|Assess the feasibility of using a new imaging technique called “cone beam imaging” to localize a liver tumor immediately prior to external beam radiotherapy.|Up to 2 hours|||participants|||Number
757176|NCT00600704|Primary|Mean Number of Packed Red Cells Units Transfused During Hospital Stay||20 months|Patients between ages 18-85 undergoing elective cardiac surgery under cardiopulmonary bypass||packed red cells units|Participants|95% Confidence Interval|Mean
757177|NCT00600743|Secondary|Sickness Report|"Response to question How sick do you feel measured on a 150 mm line anchored by none at all (0 mm left end) and extremely (150 mm right end)"|25-30 min after drug or placebo|||mm||Standard Error|Mean
757178|NCT00600743|Secondary|Fullness Rating|"rating of How full do you feel by marking the feeling on a 150 mm line anchored at one end from 0 (not at all) to 150 (most imaginable)."|25-30 min after taking drug|||mm||Standard Error|Mean
757179|NCT00600743|Primary|Food Intake for 4 mg Dose of CCK Agonist vs Placebo Meal Conditions|Food Intake at 25-30 min after having drug or placebo under normal and binge eating instructions|25-30 min after taking drug|Subjects had to complete all trials of the protocol successfully||grams||Standard Error|Mean
757180|NCT00600756|Secondary|The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Participants at Month 12 in the Safety Population With Individual Symptoms Assessed by the Modified UKU: Sexual Dysfunction in Men|Symptoms are graded according to degree (not present to severe) and causal relationship (improbable, possible, probable). Sexual dysfunction in men is defined as number of men who show the individual adverse event (AE) sexual dysfunction. An individual AE sexual dysfunction is defined as an AE with a worse degree of sexual dysfunction compared with baseline and with a possible or probable relationship to study drug.|Month 12|"Safety population at Month 12 is presented. Quetiapine XR: Out of 231 evaluable men, 111 were missing individual AE “Sexual Dysfunction” data”.
Risperidone: Out of 231 evaluable men, 106 were missing individual AE “Sexual Dysfunction” data”."||Participants|||Number
757181|NCT00600756|Secondary|The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Participants at Month 12 in the Safety Population With Individual Symptoms Assessed by the Modified UKU: Hyperprolactinaemia in Women|Symptoms are graded according to degree (not present to severe) and causal relationship (improbable, possible, probable). Hyperprolactinaemia in women is defined as number of women who show the individual adverse event (AE) hyperprolactinaemia. An individual AE Hyperprolactinaemia is defined as an AE with a worse degree of hyperprolactinaemia compared with baseline and with a possible or probable relationship to study drug.|Month 12|"Safety population at Month 12 is presented. Quetiapine XR: Out of 160 evaluable women, 73 were missing individual AE “Hyperprolactinaemia” data.
Risperidone: Out of 171 evaluable women, 74 were missing individual AE “Hyperprolactinaemia” data”."||Participants|||Number
757182|NCT00600756|Secondary|The Safety and Tolerability of Quetiapine XR vs Risperidone by Evaluating the Number of Participants at Month 12 in Safety Population With Individual Symptoms Assessed by the Modified Udvalg for Kliniske Undersogelser, Side Effect Rating Scale: Neurologic|Symptoms are graded according to degree (not present to severe) and causal relationship (improbable, possible, probable). An individual AE is defined as an AE with a worse degree compared with Baseline and with a possible or probable relationship to study drug.|12 months|The Safety population at Month 12 is presented. For Quetiapine XR, 4 subjects did not take study drug, resulting in 391 evaluable subjects compared with the Randomized population (395 subjects). For Risperidone, 1 subject did not take study drug, results in 402 evaluable subjects compared with the Randomized population (403 subjects).||Participants|||Number
757183|NCT00600756|Secondary|The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Mean Change From Baseline to Month 12 in Prolactin Levels in the Safety Population|The normal range for men is 0 to 14, and for women is 0 to 24.|12 months|The Safety population at Month 12 is presented. For Quetiapine XR, 4 subjects did not take study drug, resulting in 391 evaluable subjects compared with the Randomized population (395 subjects). For Risperidone, 1 subject did not take study drug, results in 402 evaluable subjects compared with the Randomized population (403 subjects).||ng/mL||Standard Deviation|Mean
757184|NCT00600756|Secondary|The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Participants Who Had at Least 1 Cardiac TEAE at Month 12 in the Safety Population|Treatment-emergent adverse events are defined as adverse events that occurred after the first intake of the study medication (or on the same day).|12 months|The Safety population at Month 12 is presented. For Quetiapine XR, 4 subjects did not take study drug, resulting in 391 evaluable subjects compared with the Randomized population (395 subjects). For Risperidone, 1 subject did not take study drug, results in 402 evaluable subjects compared with the Randomized population (403 subjects).||Participants|||Number
757185|NCT00600756|Secondary|The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Extra-pyramidal Events at Month 12 in the Safety Population|Extra-pyramidal events include tremor, hypokinesia, muscle rigidity, hyperkinesia, and extrapyramidal disorder.|12 months|The Safety population at Month 12 is presented. For Quetiapine XR, 4 subjects did not take study drug, resulting in 391 evaluable subjects compared with the Randomized population (395 subjects). For Risperidone, 1 subject did not take study drug, results in 402 evaluable subjects compared with the Randomized population (403 subjects).||Events|||Number
757186|NCT00600756|Secondary|The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Participants Who Had at Least 1 Extra-pyramidal TEAE at Month 12 in the Safety Population|Treatment-emergent adverse events are defined as adverse events that occurred after the first intake of the study medication (or on the same day).|12 months|The Safety population at Month 12 is presented. For Quetiapine XR, 4 subjects did not take study drug, resulting in 391 evaluable subjects compared with the Randomized population (395 subjects). For Risperidone, 1 subject did not take study drug, results in 402 evaluable subjects compared with the Randomized population (403 subjects).||Participants|||Number
757187|NCT00600756|Secondary|The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Participants Who Discontinued the Study Because of an TEAE at Month 12 in the Safety Population|Treatment-emergent adverse events are defined as adverse events that occurred after the first intake of the study medication (or on the same day).|12 months|The Safety population at Month 12 is presented. For Quetiapine XR, 4 subjects did not take study drug, resulting in 391 evaluable subjects compared with the Randomized population (395 subjects). For Risperidone, 1 subject did not take study drug, results in 402 evaluable subjects compared with the Randomized population (403 subjects).||Participants|||Number
757188|NCT00600756|Secondary|The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Participants With a Treatment-emergent Adverse Event (TEAEs) at Month 12 in the Safety Population|Treatment-emergent adverse events are defined as adverse events that occurred after the first intake of the study medication (or on the same day).|12 months|The Safety population at Month 12 is presented. For Quetiapine XR, 4 subjects did not take study drug, resulting in 391 evaluable subjects compared with the Randomized population (395 subjects). For Risperidone, 1 subject did not take study drug, results in 402 evaluable subjects compared with the Randomized population (403 subjects).||Participants|||Number
757189|NCT00600756|Secondary|The Compliance of Patients Taking Quetiapine XR Versus Risperidone at Month 12 by Evaluating the Number of Participants Who Returned Study Drug at Month 12 in the ITT Population||12 months|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.||Participants|||Number
757191|NCT00600756|Secondary|Number of Participants Using Antidepressants at Month 12 in the ITT Population|"The number of participants who were taking at least 1 antidepressant at Month 12. Antidepressants are all concomitant medications classified in the Anatomical Therapeutic Chemical(ATC)Subgroup N06-Antidepressants."|12 months|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.||Participants|||Number
757192|NCT00600756|Secondary|The Effect of Quetiapine XR Versus Risperidone Regarding Health Economics Outcomes by Evaluating the Time Between First Study Drug Intake and First Hospitalization for Patients With 1 Hospitalization in the ITT Population||12 months|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.||Days||Standard Deviation|Mean
757193|NCT00600756|Secondary|Number of Subjects Who Had an Unscheduled Visits Due to Worsening of Schizophrenia, Dose Change, or Adverse Event at Month 12 in the ITT Population|Unscheduled visits due to worsening of schizophrenia, dose change or adverse event including the hospitalizations due to psychiatric disorders during the study (i.e. from Visit 1 to Termination date + 30 days) in inpatients units, in emergency wards and in day clinics.|Month 12|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.||Participants|||Number
757194|NCT00600756|Secondary|The Effect of Quetiapine XR Versus Risperidone Regarding Health Economics Outcomes by Evaluating the Participants With at Least 1 Hospitalization Due to Psychiatric Disorders at Month 12 in the ITT Population|All hospitalizations due to psychiatric disorders during the study (i.e. from Visit 1 to Termination date + 30 days) in inpatients units, in emergency wards, and in day clinics.|12 months|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.||Participants|||Number
757195|NCT00600756|Secondary|The Effect of Quetiapine XR Versus Risperidone Regarding Health Economics Outcomes by Evaluating the Mean Number of Lost School/Work Days at Month 12 in the ITT Population|"Workers and students are defined from the modified vocational status index excluding subjects Retired or Unemployed, whether or not expected to work."|12 months|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.||Days||Standard Deviation|Mean
757196|NCT00600756|Secondary|To Evaluate the Effect of Quetiapine XR Versus Risperidone at Month 12 in the ITT Population Regarding Health Economics Outcomes by Evaluating the Functional Improvement Rate of the Modified Vocational Status Index/ Location Code Index: Stable State|Stable State was defined as having the same status in occupational and residential status as at Baseline.|12 months|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.||Participants with stable state|||Number
757197|NCT00600756|Secondary|Evaluation of Effect of Quetiapine XR Versus Risperidone on the Health-related Quality of Life of Patients With Schizophrenia by Evaluating the Change From Baseline in EQ-5D(Euro Quality of Life-5 Dimension) Index Score at Month 12 in the ITT Population.|The Euro Quality of Life - 5 dimension index (EQ-5D) is the result of the application of a formula that essentially attaches values (also called weights) to each of the levels (no, some, or heavy problems) in each dimension (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). These weights are issued from a representative sample of the general population. The total possible maximum value was 1 (healthy life) and the minimum value was 0 (death).|12 months|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.||Scores on a scale||Standard Error|Least Squares Mean
757198|NCT00600756|Secondary|The Effect of Quetiapine XR Versus Risperidone by Evaluating the Relapse Rate at Month 12 in the ITT Population|Relapse is defined as at least one increase of greater than or equal to 2 points on the CGI-SCH overall severity score during the treatment period or at least one hospitalization due to psychiatric disorders during the treatment period.|12 months|The Reported population is participants who showed relapse over time, from baseline to Month 12.||Participants|||Number
757199|NCT00600756|Secondary|The Effect of Quetiapine XR Versus Risperidone at Month 12 in the ITT Population on Core Schizophrenic and Depressive Symptoms by Evaluating the Change From Baseline in the Calgary Depression Scale for Schizophrenia (CDSS) Total Score|The CDSS total score is the sum of 9 questions and ranges from 0 to 27. The higher the score, the more severe are the symptoms.|12 months|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.||Scores on a scale||Standard Error|Least Squares Mean
757200|NCT00600756|Secondary|The Effect of Quetiapine XR Versus Risperidone at Month 12 in the ITT Population on Core Schizophrenic and Depressive Symptoms by Evaluating the Change From Baseline in CGI-SCH Overall Severity Score|For the CGI-SCH (Clinical Global Impression-Schizophrenia severity of illness scale) overall severity of illness, the score ranged from 1 (normal, not ill) to 7 (among the most severely ill). Change from baseline in CGI-SCH score was divided into 3 classes: worsening (change score>0), stable (change score=0) and improved (change score<0).|12 months|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.||Scores on a scale||Standard Deviation|Mean
757251|NCT00607321|Primary|Number of Participants With Target Vessel Failure (TVF) at 30 Days Post Procedure.|TVF was reported if any of the following events occurred: Recurrent MI in territory not clearly attributed to a vessel other than the target lesion; Cardiac death not clearly due to a non-target vessel endpoint or Clinically driven target revascularization.|30 days|||Participants|||Number
757201|NCT00600756|Secondary|The Effect of Quetiapine XR Versus Risperidone at Month 12 in the ITT Population on Core Schizophrenic and Depressive Symptoms by Evaluating the Change From Baseline in CGI-SCH Overall Severity Score (Improved).|For the CGI-SCH overall severity of illness, the score ranged from 1 (normal, not ill) to 7 (among the most severely ill). CGI-SCH score was divided into 3 classes: worsening (change score>0), stable (change score=0) and improved (change score<0). Change from baseline in CGI-SCH overall severity of illness in number of participants with CGI-SCH overall severity score improvement.|12 months|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.||Participants|||Number
757202|NCT00600756|Secondary|The Remission Rate in Both the Quetiapine XR Group and the Risperidone Group at Month 12 in the ITT Population|Remission was defined as a SWN-K total score greater than or equal to 80. The reported population is participants who showed remission over, time from baseline to Month 12|12 months|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.||Participants|||Number
757203|NCT00600756|Secondary|Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Subscale Score: Emotional Regulation at Month 12 in the ITT Population.|The SWN-K total score is the sum of 5 subscores (4 questions each): physical functioning, social integration, mental functioning, self-control, and emotional regulation. The subscores are rated using a 6-point scale (the higher the grade, the better the response). Possible subscores range from 4 to 24.|Baseline and 12 months|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.||Scores on a scale||Standard Error|Least Squares Mean
757204|NCT00600756|Secondary|Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Subscale Score: Self-control at Month 12 in the ITT Population.|The SWN-K total score is the sum of 5 subscores (4 questions each): physical functioning, social integration, mental functioning, self-control, and emotional regulation. The subscores are rated using a 6-point scale (the higher the grade, the better the response). Possible subscores range from 4 to 24.|Baseline and 12 months|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.||Scores on a scale||Standard Error|Least Squares Mean
757205|NCT00600756|Secondary|Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Subscale Score: Mental Functioning at Month 12 in the ITT Population.|The SWN-K total score is the sum of 5 subscores (4 questions each): physical functioning, social integration, mental functioning, self-control, and emotional regulation. The subscores are rated using a 6-point scale (the higher the grade, the better the response). Possible subscores range from 4 to 24.|Baseline and 12 months|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.||Scores on a scale||Standard Error|Least Squares Mean
757206|NCT00600756|Secondary|Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Subscale Score: Social Integration at Month 12 in the ITT Population.|The SWN-K total score is the sum of 5 subscores (4 questions each): physical functioning, social integration, mental functioning, self-control, and emotional regulation. The subscores are rated using a 6-point scale (the higher the grade, the better the response). Possible subscores range from 4 to 24.|Baseline and 12 months|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.||Scores on a scale||Standard Error|Least Squares Mean
757207|NCT00600756|Secondary|Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Subscale Score: Physical Functioning at Month 12 in the ITT Population.|The SWN-K total score is the sum of 5 subscores (4 questions each): physical functioning, social integration, mental functioning, self-control, and emotional regulation. The subscores are rated using a 6-point scale (the higher the grade, the better the response). Possible subscores range from 4 to 24.|Baseline and 12 months|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.||Scores on a scale||Standard Error|Least Squares Mean
757208|NCT00600756|Secondary|Change From Baseline in Mean Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Total Score at Month 12 in the Intent-to-Treat (ITT) Population|The SWN-K is comprised of 20 questions, each of which is rated using a 6-point scale ranging from 1 (not at all) to 6 (very much). Possible scores range from 20 to 120, with higher scores implying higher subjective well-being.|Baseline and Month 12|For Per Protocol at Month 12 analysis, the difference from Randomized analysis (395) was no study drug (4); SWN-K score missing (12), and did not meet inclusion criteria (206) for Quetiapine XR. For Risperidone, the difference from Randomized analysis (403) was no study drug (1); SWN-K score missing (10), and did not meet inclusion criteria (201).||Scores on a scale||Standard Error|Least Squares Mean
757209|NCT00600756|Secondary|Change From Baseline in Mean Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Total Score at Month 12 in the Per Protocol Population|The SWN-K is comprised of 20 questions, each of which is rated using a 6-point scale ranging from 1 (not at all) to 6 (very much). Possible scores range from 20 to 120, with higher scores implying higher subjective well-being.|Baseline and Month 12|For Per Protocol at Month 12 analysis, the difference from Randomized analysis (395) was no study drug (4); SWN-K score missing (12), and did not meet inclusion criteria (206) for Quetiapine XR. For Risperidone, the difference from Randomized analysis (403) was no study drug (1); SWN-K score missing (10), and did not meet inclusion criteria (201).||Scores on a scale||Standard Error|Least Squares Mean
757303|NCT00607672|Primary|Plasminogen Activator Inhibitor-1 (PAI-1) Response|To compare the effects of AT1 receptor antagonism or ACE inhibition versus placebo on the fibrinolytic responses to CPB as measured by PAI-1 response|From the start of surgery until postoperative day 2|||ng/mL||Standard Error|Mean
757210|NCT00600756|Primary|Responder Rate at Month 6 in the Per Protocol Population Using the Subjective Well-being Under Neuroleptics Scale, Short Version (SWN-K) Total Score|The SWN-K is comprised of 20 questions, rated on a 6-point scale from 1 (not at all) to 6 (very much). Scores range from 20 to 120, with higher scores implying higher subjective well-being. A responder is defined as a subject with an increase of 10 points or 20% from baseline in SWN-K total score (non-inferiority limit of -9.7% in responder rate)|6 months|For Per Protocol at Month 6 analysis, the difference from Randomized analysis (395) was no study drug (4); SWN-K score missing (12), and did not meet inclusion criteria (169) for Quetiapine XR. For Risperidone, the difference from Randomized analysis (403) was no study drug (1); SWN-K score missing (10), and did not meet inclusion criteria (160).||Participants|||Number
757211|NCT00606502|Secondary|Adverse Events of Patients Receiving Pralatrexate vs. Erlotinib||Assessed every 2 weeks while on treatment through safety follow-up visit (35 +/-5 days post-last dose) or early termination visit (at time of withdrawal).|"Adverse Events (AEs) and Serious AEs (SAEs) are presented regardless of causality for patients who received at least one dose of Pralatrexate or Erlotinib. Events were graded by the investigator using the NCI CTCAE Scale (version 3.0) which provides a grading scale for each AE term.
Grade 3 = Severe
Grade 4 = Life-threatening or disabling"||Treated Participants|||Number
757212|NCT00606502|Secondary|Progression-free Survival (PFS) of Patients Receiving Pralatrexate vs. Erlotinib|PFS was calculated as the number of days from randomization to the date of radiological evidence of PD or death due to any cause.|Assessed every 8 weeks for the first 24 weeks, then every 16 weeks for up to 2 years or until PD or start of subsequent treatment.|Patients who were alive without a disease response assessment of PD as of the data cut-off date were censored at the last disease assessment date or the date of randomization, whichever was later. Patients with no response assessments after baseline were censored at date of randomization resulting in a duration of PFS of 1 day.||months||95% Confidence Interval|Median
757213|NCT00606502|Secondary|Response Rate (RR) to Treatment of Patients Receiving Pralatrexate vs. Erlotinib|Number of patients whose tumors responded to Pralatrexate or Erlotinib, using the Response Criteria in Solid Tumors (RECIST).|Assessed every 8 weeks for the first 24 weeks, then every 16 weeks for up to 2 years or until PD or start of subsequent treatment.|Based on all treated patients with measurable disease at baseline. Patients who were declared unevaluable for response were considered nonresponders and were included in the calculation of response rate. Patients were unevaluable if they were off-treatment prior to first response assessment, never received treatment or had unconfirmed responses.||Participants|||Number
757214|NCT00606502|Primary|Overall Survival (OS) of Patients Receiving Pralatrexate vs. Erlotinib|OS was defined as the length of time from randomization until death due to any cause. Patients who were alive at the time of the data cut-off date were censored at the last contact date.|Assessed from date of randomization no less frequently than every 16 weeks for up to 2 years after randomization.|||Months Survival||95% Confidence Interval|Median
757215|NCT00606554|Secondary|Complications (Death During Wean, Ventilator-associated Pneumonia During Wean, Self Extubation, Re-intubation)|This outcome is a composite outcome of the total number of participants with any one of the above-listed weaning-associated complications.|Duration of weaning (median 2 days)|||Participants|||Number
757216|NCT00606554|Secondary|Number of Spontaneous Breathing Trials Prior to Extubation||duration of study||||||
757217|NCT00606554|Secondary|Sedation Requirements||duration of study||||||
757218|NCT00606554|Secondary|Inpatient Mortality|proportion of patients in each arm who died in the hospital|28 days|ITT||Participants|||Number
757219|NCT00606554|Secondary|Duration of Hospitalization||duration of study||||||
757220|NCT00606554|Secondary|Duration of Mechanical Ventilation||duration of study||||||
757221|NCT00606554|Secondary|Duration of ICU Stay||duration of study||||||
757222|NCT00606554|Primary|Duration of Weaning|Duration of weaning was assessed as the time from the initiation of weaning (randomization) to the time of successful extubation (defined as 48 hours free of mechanical ventilation). Patients were followed for the duration of hospitalization and the time of weaning onset and successful liberation from the ventilator was noted.|Continuous (median weaning duration was 2 days)|ITT||Days||Inter-Quartile Range|Median
757223|NCT00606580|Secondary|Number of Subjects With a Relapse on or After Day 42||Day 168|||participants|||Number
757224|NCT00606580|Secondary|Number of All Ulcerated Lesions Achieving 100% Re-epithelialization by Day 42||Day 42|mITT dataset||Ulcerated lesions|Participants||Number
757225|NCT00606580|Secondary|Number of Subjects Achieving Re-epithelialization of All Treated Ulcerated Lesions Without Subsequent Relapse|Number of Subjects Achieving Re-epithelialization of All Treated Ulcerated Lesions at Day 42 without Subsequent Relapse from Day 42 Onward,|Day 168|mITT dataset||participants|||Number
757226|NCT00606580|Secondary|Number of Subjects Achieving Re-epithelialization of the Index Lesion Without Relapse|Number of Subjects Achieving Re-epithelialization of the Index Lesion by Day 42 without Relapse from Day 42 Onward, Imputing Relapse for any Subject with a Missing Visit after Day 42|Day 168|mITT population||participants|||Number
757227|NCT00606580|Secondary|Number of Subjects Achieving Initial Clinical Improvement of the Index Lesion||Day 42|||participants|||Number
757228|NCT00606580|Secondary|Estimated Percentage of All Treated Ulcerated Lesions Without Relapse at Day 98||Days 98|mITT dataset||percentage of lesions|Participants|95% Confidence Interval|Number
757229|NCT00606580|Secondary|Estimated Percentage of All Treated Ulcerated Lesions Without Relapse at Day 49||Days 49|mITT dataset||percentage of lesions|Participants|95% Confidence Interval|Number
757230|NCT00606580|Secondary|Estimated Percentage of All Treated Ulcerated Lesions Without Relapse at Day 42||Days 42|mITT dataset||Percentage of lesions|Participants|95% Confidence Interval|Number
757231|NCT00606580|Secondary|Estimated Percentage of Subjects With Re-epithelialization of the Index Lesion Without Relapse at Various Times of Follow-up||Days 42, 49, and 98|mITT dataset. The data show that 95.8% of the Vehicle-treated subjects remaining in the study at Day 168 (the percentage excludes the 17.6% of subjects who dropped out or were withdrawn early due to treatment failure) had re-epithelialization of the index lesion.||percentage of participants||95% Confidence Interval|Number
757329|NCT00607867|Primary|Change in Overnight Fasting Glucose Concentration at 5 Weeks From Baseline|Overnight fasting glucose concentration was measured before dietary intervention and after 5 weeks of dietary intervention.|baseline and 5 weeks after dietary intervention|||mg/dl||Standard Error|Mean
757232|NCT00606580|Secondary|Estimated Percentage Subjects With Re-epithelialization of the Index Lesion Without Relapse|For the first of the above analyses, subjects were considered to have endpoint events at the first assessment on or before Day 42 where complete re-epithelialization occurred at the index lesion that was not followed by a later assessment where ulceration was present. Subjects who did not have complete re-epithelialization by Day 42 or who relapsed after Day 42 were censored in the analysis at the Day 42 assessment. This analysis was only to be conducted through Day 42.|Day 42|mITT dataset||percentage of participants||95% Confidence Interval|Number
757233|NCT00606580|Secondary|Final Clinical Cure Rate (Per Protocol Dataset)|Final clinical cure was defined as an index lesion that met the criteria for initial clinical cure without relapse. Definitions for index lesion outcomes as described in the primary outcome measure.|Day 42, 98, and 168|Per protocol – all randomized subjects who received at least one treatment of study drug and whose outcomes at Day 42, Day 98 (if applicable) and Day 168 could be assessed. However, a subject was still considered per-protocol if withdrawn early for treatment failure.||participants|||Number
757234|NCT00606580|Primary|Final Clinical Cure Rate|"Final clinical cure was defined as an index lesion that met the criteria for initial clinical cure without relapse. Definitions for index lesion outcomes were as follows:
Initial Clinical Improvement: At least 50% to 99% reduction in the size of the measured lesion from the baseline measurement by the Day 42 evaluation.
Initial Clinical Cure: 100% re-epithelialization (ie, a 0 x 0 length x width measurement) of the lesion at the nominal Day 42 evaluation, or initial clinical improvement followed by 100% re-epithelialization by Day 98.
Relapse: Initial clinical cure followed by re-ulceration by Day 168, or initial clinical improvement followed by lesion enlargement by Day 168.
Final Clinical Cure: Initial clinical cure without relapse through study Day 168.Clinical Failure: Lack of at least initial clinical improvement by Day 42, or relapse."|Day 42, 98, and 168|Modified intention-to-treat (mITT) – all subjects randomized who received at least one treatment of study drug.||participants|||Number
757235|NCT00606593|Secondary|Mean Total Sleep Time (TST)|"TST was the amount of actual sleep time measured in minutes scored as non-wake (i.e., sleep stage 1, 2, slow-wave sleep, or rapid eye movement (sleep)).
Mean values were calculated based on 2 treatment PSG nights. PSG nights identified as non-evaluable by protocol violation were excluded. If a mean value could not be calculated because the value for 1 PSG night was missing or non-evaluable, the valid value for the other PSG night was used. If during a double-blind treatment period a valid PSG was performed but the TST was missing (e.g., the subject did not sleep or persistent sleep did not occur), the missing value was substituted with the worst value recorded for the subject during the study (single-blind period included)."|2 treatment nights|Number of evaluable patients for this parameter in the per protocol set. Only subjects with all 5 valid values are included in this analysis.||minutes||Standard Deviation|Mean
757236|NCT00606593|Primary|Mean Wake Time After Sleep Onset (WASO)|"WASO was the time in minutes scored as wake between the onset of persistent sleep and lights on, where the onset of persistent sleep was the beginning of the first continuous 20 epochs (10 min) scored as non-wake.
Mean values were calculated based on 2 treatment PSG nights. PSG nights identified as non-evaluable due to protocol violation were excluded. If a mean value could not be calculated because the value for 1 PSG night was missing or non-evaluable, the valid value for the other PSG night was used. If during a double-blind treatment period a valid PSG was performed but the WASO was missing (e.g., persistent sleep did not occur), the missing value was substituted with the highest value recorded for the subject during the study (single-blind period included)."|2 treatment nights|Number of evaluable patients for this parameter in the per protocol set. Only subjects with all 5 valid values are included in this analysis.||minutes||Standard Deviation|Mean
757237|NCT00606632|Secondary|Safety Evaluation of 124I -cG250 in Patients With Renal Masses||6 months||||||
757238|NCT00606632|Primary|Reading of Diagnostic CT Imaging in Renal Masses to Decide on the Presence or Absence of ccRCC.||6 months||||||
757239|NCT00606632|Primary|Sensitivity - Proportion of Participant Determinded to Have Clear Cell Renal Carcinoma (ccRCC) by PET/CT.|Proportion of participants with ccRCC that were correctly identified on the PET/CT images.|6 months|ITD (Intend-to-Diagnose)observed case: All subjects who were enrolled and infused with the investigational product and who had a “standard-of-truth” (histopathology) result and images evaluated as readable by the blinded readers||Proportion of participants||95% Confidence Interval|Number
757240|NCT00606684|Secondary|Time to >= 100 Milliliter (mL) Increase From Baseline in FEV1 (0-4 Hours Post-dose)|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcibly exhaled from the lungs in one second. Time until participants achieve >=100 mL increase from Baseline FEV1 (0-4 hours post-dose) are presented. Baseline FEV1 is defined as the mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1. Time to >= 100mL increase from Baseline (on Day 1) is defined as the time until the first post-dose FEV1 (on Day 1) is >= 100mL above Baseline FEV1. Time to >= 100mL increase from Baseline (on Day 1) was calculated only if there was at least one non-missing FEV1 value recorded within the first hour of dosing. Time to >= 100mL increase from Baseline was assessed over the 0-4 time period and only used lung function data recorded up to 6 hours post the Day 1 dose. Participants who did not achieve >= 100mL increase from Baseline over this time period were censored.|Baseline and Day 1|ITT Population. Only participants available at the indicated time points were assessed.||Minutes||Full Range|Median
757241|NCT00606684|Secondary|Time to >= 12% Increase From Baseline in FEV1 (0-4 Hours Post-dose)|Forced expiratory volume in one second (FEV1) is a measure of lung function defined as the maximal amount of air that can be forcibly exhaled from the lungs in one second. Time until participants achieved a >=12% increase from Baseline FEV1 (0-4 hours post-dose) are presented. Baseline FEV1 is defined as the mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1. If one of these two assessments was missing then Baseline is defined as the single pre-dose FEV1 on Day 1.Time to >= 12% increase from Baseline (on Day 1) is defined as the time when the first post-dose FEV1 (on Day 1) is >=12% above Baseline FEV1. Time to >= 12% increase from Baseline was assessed over the 0-4 hour time period and only used lung function data recorded up to 6 hours post the Day 1 dose.|Baseline and Day 1|ITT Population. Only participants available at the indicated time points were assessed.||Minutes||Full Range|Median
757252|NCT00607373|Other Pre-specified|HDL-C at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||mg/dL||Inter-Quartile Range|Median
757242|NCT00606684|Secondary|Time-adjusted Area Under the Curve (AUC) (i.e. Weighted Mean Change From Baseline) for 24 Hour Serial FEV1 on Days 1 and 28|Weighted mean was derived by calculating the AUC, and then dividing by the relevant time interval. The weighted mean change from Baseline was calculated as the weighted mean of the 24 hour serial FEV1 measures on Day 1 and Day 28 minus the Baseline value. Serial FEV1 measurements were taken on Day 1 and Day 28 (post-dose FEV1 after 5, 15, 30 minutes and 1, 2, 4, 8, 12, 23 and 24 hours). AUC was calculated only when there was at least 3 non-missing values between 0 and 24 hours and must have a value at 23 or 24 hours. Analysis performed used a repeated measures model with covariates of treatment, baseline, sex, age, smoking status (at Screening), reversibility stratum, Day (nominal), day by Baseline, and day by treatment interactions.|Baseline to Day 28|ITT Population. The number of participants presented represents those with data available at either of time points being presented. The numbers given in the category titles represent the number of participants with data available at the time point given.||Liters||Standard Error|Least Squares Mean
757243|NCT00606684|Primary|Mean Change From Baseline in Trough (Pre Bronchodilator and Pre Dose) FEV1 on Day 29|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcibly exhaled from the lungs in one second. Baseline FEV1 is defined as the mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1. If one of these two assessments was missing then Baseline is defined as the single pre-dose FEV1 value at Day 1. The trough FEV1 is defined as the mean of the FEV1 values obtained at 23 and 24-hours after dosing on Day 28 and the Baseline FEV1 is defined as the mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1. Change from Baseline in trough FEV1 was calculated as the value on Day 29 minus the value at Baseline. Analysis was performed using Analysis of Covariance (ANCOVA) using Last Observation Carried Forward (LOCF) with covariates of baseline, sex, age, smoking status (at screening), reversibility stratum, and treatment (trt).|Baseline (BL) and Day 29|Intent-to-Treat (ITT) Population: all participants who were randomized to trt and received >= 1 dose of study medication. When the endpoint was missing, the last valid non-missing on-trt, post-BL trough assessment was used instead. Only those participants available at the specified time points without missing covariate information were analyzed.||Liters||Standard Error|Least Squares Mean
757244|NCT00606801|Secondary|Performance on the Modified Stroop Task (Cocaine-Stroop)|The Cocaine-Stroop task measures attention capture (attentional bias) secondary to cocaine cues; (Stroop effect - calculated as the difference between mean RT on cocaine words and mean RT on control words). Subjects completed 2 counterbalanced blocks (150 trials per block). One block contained 15 cocaine words and neutral words in a mixed order. The other block contained 15 control words matched in length and frequency to cocaine words, and a different set of neutral words. Subjects were required to indicate the colors in which the words were written as quickly and accurately as possible. Reaction times for identification of word color was measured. In addition, the difference in RT to words following cocaine and control words were measured (carry-over effect). Complete data for 3 participants (2 placebo and 1 galantamine) were not capture due to experimenter and computer errors.|Baseline, Day 5 and Day 10|||milliseconds||Standard Deviation|Mean
757245|NCT00606801|Secondary|Performance on the Sustained Attention to Response Task (SART).|"The SART is a Go / NoGo task measuring the ability to activate or inhibit responses. Cocaine users are know to have deficits in response inhibition on such tasks. The number of errors on NoGo and Go trials, as well as the mean reaction time (RT in milliseconds) for correct responses on Go Trials were measured.
Complete data for 3 subjects in the Placebo group, and for 1 subject in the galantamine group were not capture do to experimenter and computer errors."|Baseline, Day 5 and Day 10|Participants analyzed are those that completed the treatment phase.||milliseconds||Standard Deviation|Mean
757246|NCT00606801|Primary|Performance on 3 Cognitive Tests From the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP, PAL and PRM.|Rapid Visual Processing test (RVIP) is a measure of sustained attention with a small working memory component that is sensitive to cholinergic enhancers. In the RVIP, subjects must detect either odd or even 3 digit sequences appearing in a box in a pseudo-random order at 100 digits per minute. Reaction time (RT) to correct answers, total hits, correct rejections and A' (sensitivity to target sequences) were determined. Paired Associate Learning (PAL) measures visual memory and new learning by testing a the ability to remember the initial location of a pattern after it is re-presented in the middle of the screen. Errors result in a reminder presentation of the original location. The stages completed and number of errors are measures of interest. Pattern Recognition Memory (PRM) tests visual pattern recognition memory in a two choice forced discrimination paradigm. 12 visual patterns are presented, then the subject must choose between each of these patterns and a novel pattern.|Baseline, Day 5 and Day 10|There were a total of 28 completers, 14 for each treatment group. However, CANTAB data was not stored on the hard drive for one subject in the Galantamine group.||milliseconds||Standard Deviation|Mean
757247|NCT00607321|Secondary|Number of Participant With Target Vessel Failure at 12 Months|TVF was reported if any of the following events occurred: Recurrent MI in territory not clearly attributed to a vessel other than the target lesion; Cardiac death not clearly due to a non-target vessel endpoint or Clinically driven target revascularization.|12 month|Includes all subjects receiving bifurcation stents and having evaluable data.||participants|||Number
757248|NCT00607321|Secondary|Number of Participants With Target Vessel Failure at 9 Months.|TVF was reported if any of the following events occurred: Recurrent MI in territory not clearly attributed to a vessel other than the target lesion; Cardiac death not clearly due to a non-target vessel endpoint or Clinically driven target revascularization.|9 month|Includes all subjects receiving bifurcation stents and having evaluable data||participants|||Number
757249|NCT00607321|Secondary|Number of Participants With Target Vessel Failure (TVF) at 6 Months|TVF was reported if any of the following events occurred: Recurrent MI in territory not clearly attributed to a vessel other than the target lesion; Cardiac death not clearly due to a non-target vessel endpoint or Clinically driven target revascularization.|6 month|Includes all patients receiving bifurcation stent and having evaluable data.||participants|||Number
757250|NCT00607321|Secondary|Device Success|Device success is reported as Historical-standard definition: attainment of <50% residual stenosis of all target lesion/s using only the assigned device and any adjunct stents as specified in the Investigational Plan.|During index procedure|ITT included all subjects after a run-in subject at each site.||participants|||Number
771364|NCT00723554|Primary|Systolic Blood Pressure - Iloprost PD-6 (Period 1)|Systolic blood pressure was measured immediately prior to first dosing with Iloprost PD-15|Day 1|Safety population||mmHg||Standard Deviation|Mean
757253|NCT00607373|Other Pre-specified|Percentage Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Primary Efficacy Time Point (PET)|HDL-C was measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||percentage of baseline||Inter-Quartile Range|Median
757254|NCT00607373|Other Pre-specified|Apo-A1 at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||mg/dL||Standard Deviation|Mean
757255|NCT00607373|Other Pre-specified|Percent Change From Baseline in Apolipoprotein A1 (Apo-A1) at Primary Efficacy Time Point (PET)|Apo-A1 was measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||percentage of baseline||Standard Deviation|Mean
757256|NCT00607373|Other Pre-specified|Ratio of LDL-C to HDL-C at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||ratio||Standard Deviation|Mean
757257|NCT00607373|Other Pre-specified|Change From Baseline in Ratio of Low-density Lipoprotein Cholesterol (LDL-C) to High-density Lipoprotein Cholesterol (HDL-C) at Primary Efficacy Time Point (PET)|LDL-C and HDL-C were measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||percentage of baseline||Standard Deviation|Mean
757258|NCT00607373|Other Pre-specified|VLDL-C at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||mg/dL||Inter-Quartile Range|Median
757259|NCT00607373|Other Pre-specified|Percentage Change From Baseline in Very-Low-Density Lipoprotein Cholesterol (VLDL-C) at Primary Efficacy Time Point (PET)|VLDL-C was measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||percentage of baseline||Inter-Quartile Range|Median
757260|NCT00607373|Other Pre-specified|Lipoprotein(a) at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||mg/dL||Standard Deviation|Mean
757261|NCT00607373|Other Pre-specified|Percentage Change From Baseline in Lipoprotein(a) at Primary Efficacy Time Point (PET)|Lipoprotein(a) was measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||percentage of baseline||Standard Deviation|Mean
757262|NCT00607373|Other Pre-specified|Triglycerides at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||mg/dL||Inter-Quartile Range|Median
757263|NCT00607373|Other Pre-specified|Percentage Change From Baseline in Triglycerides at Primary Efficacy Time Point (PET)|Triglycerides were measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||percentage of baseline||Inter-Quartile Range|Median
757264|NCT00607373|Secondary|Non-HDL-C at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||mg/dL||Standard Deviation|Mean
757297|NCT00607672|Secondary|Acute Kidney Injury|Acute kidney injury (AKI) was defined according to Acute Kidney Injury Network (AKIN) criteria,specifically any increase in subject serum creatinine concentration of 50% or 0.3 mg/dL (26.5 umol/L) within 72 hours of surgery.|From the start of surgery until postoperative day 3|||percentage of patients|||Number
757265|NCT00607373|Secondary|Percentage Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Primary Efficacy Time Point (PET)|Non-HDL-C was measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||percentage of baseline||Standard Deviation|Mean
757266|NCT00607373|Primary|LDL-C at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||mg/dL||Standard Deviation|Mean
757267|NCT00607373|Secondary|Total Cholesterol at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||mg/dL||Standard Deviation|Mean
757268|NCT00607373|Secondary|Percentage Change From Baseline in Total Cholesterol at Primary Efficacy Time Point (PET)|Total cholesterol was measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||percentage of baseline||Standard Deviation|Mean
757269|NCT00607373|Secondary|Apo-B at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28 )|Full analysis set||mg/dL||Standard Deviation|Mean
757270|NCT00607373|Secondary|Percent Change From Baseline in Apolipoprotein B (Apo-B) at Primary Efficacy Time Point|Apo-B was measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||percentage of baseline||Standard Deviation|Mean
757271|NCT00607373|Primary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Primary Efficacy Time Point|LDL-C was measured in mg/dL. Samples were taken following an overnight fast. For patients with triglycerides <400 mg/dL, LDL-C was obtained using Friedewald’s calculation; and for patients with triglycerides >=400 mg/dL, LDL-C was directly measured by the central laboratory using ultracentrifugation. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. If the Study Day 1 and screening LDL-C values were >12% different (relative to the maximum value), then the screening value was not used, because the Study Day 1 value represents the best estimate of the patient's condition at the beginning of study drug administration. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set (FAS). The FAS, which represents the practically-feasible intent-to-treat (ITT) population as delineated in ICH Guideline E9, consists of treated participants with a valid baseline and at least one post-baseline LDL-C measure.||percentage of baseline||Standard Deviation|Mean
757272|NCT00607386|Secondary|Single- and Repeat-Dose Pharmacokinetics - Volume of Distribution at Steady State (Vss)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vss is the apparent volume of distribution at steadystate.|Weeks 1 and 27|"PK population with evaluable participants for this endpoint. In the categories listed below, N signifies the number of participants evaluable for the timepoint."||milliliter per kilogram||Standard Deviation|Mean
757273|NCT00607386|Secondary|Single- and Repeat-Dose Pharmacokinetics - Clearance (CL)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.|Weeks 1 and 27|"PK population with evaluable participants for this endpoint. In the categories listed below, N signifies the number of participants evaluable for the timepoint."||milliliter/minute/kilogram||Standard Deviation|Mean
757274|NCT00607386|Secondary|Single- and Repeat-Dose Pharmacokinetics - Mean Residence Time From Time 0 to Infinity (MRTinf)|MRTinf is an average duration of the drug in the body from time zero to infinity, and is expressed in minutes.|Weeks 1 and 27|"PK population with evaluable participants for this endpoint. In the categories listed below, N signifies the number of participants evaluable for the timepoint."||minutes||Standard Deviation|Mean
757275|NCT00607386|Secondary|Single- and Repeat-Dose Pharmacokinetics - Elimination Half-Life (t1/2)|t1/2 refers to the elimination of the drug. It is the time taken for the blood plasma concentration to reach half the concentration in the terminal phase of elimination. It is expressed in minutes and derived from the terminal slope of the concentration versus time curve.|Weeks 1 and 27|"PK population with evaluable participants for this endpoint. In the categories listed below, N signifies the number of participants evaluable for the timepoint."||minutes||Standard Deviation|Mean
757276|NCT00607386|Secondary|Single- and Repeat-Dose Pharmacokinetics - Area Under the Serum Concentration-Time Curve From Time 0 to Infinity (AUCinf)||Weeks 1 and 27|"PK population with evaluable participants for this endpoint. In the categories listed below, N signifies the number of participants evaluable for the timepoint."||minute*nanogram per milliliter||Standard Deviation|Mean
786175|NCT00833690|Secondary|Change in Serum Urate|Change from an Average of Baseline and Screening Visits|Visit 03 from Baseline (i.e., between -45 days and +6 weeks)|||mg/dL||Standard Deviation|Mean
757277|NCT00607386|Secondary|Single- and Repeat-Dose Pharmacokinetics - Area Under the Serum Concentration-Time Curve From Time 0 to the Final Time Point With a Concentration of at Least Lower Limit of Quantitation (AUClast)||Weeks 1 and 27|PK population. In the categories listed below, “N” signifies the number of participants evaluable for the timepoint.||minute*nanogram per milliliter||Standard Deviation|Mean
757278|NCT00607386|Secondary|Single- and Repeat-Dose Pharmacokinetics - Time of Maximum Observed Serum Concentration (Tmax)||Weeks 1 and 27|PK population. In the categories listed below, “N” signifies the number of participants evaluable for the timepoint.||minutes||Standard Deviation|Mean
757279|NCT00607386|Secondary|Single- and Repeat-Dose Pharmacokinetics - Maximum Observed Serum Concentration (Cmax)||Weeks 1 and 27|Pharmacokinetic (PK) population was defined as all enrolled participants who had at least one serum concentration measurement available. In the categories listed below, “N” signifies the number of participants evaluable for the timepoint.||nanogram per milliliter||Standard Deviation|Mean
757280|NCT00607386|Secondary|Mean Change From Baseline to Week 53 in Normalized Urinary Glycosaminoglycan (GAG) Levels|Analysis of urinary GAG levels was performed at baseline, Week 18, Week 36, and Week 53 as an assessment of the pharmacodynamic effects of Elaprase (idursulfase).|Baseline, Weeks 18, 36 and 53|Safety population. In the categories listed below, 'N' signifies the number of participants evaluable for the timepoint.||microgram/milligram creatinine||Standard Deviation|Mean
757281|NCT00607386|Primary|Safety Evaluation|An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered as a pharmaceutical product that did not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants with AEs occurred after start of study treatment until 30 days after the last infusion of idursulfase, were reported.|From the start of study treatment until 30 days after the last infusion of idursulfase, up to 53 weeks|Safety population was defined as all enrolled participants who received at least one study dose (or any portion of a dose) of idursulfase.||participants|||Number
757282|NCT00607477|Primary|Magnitude of Change in Blood Pressure||21 days|No participants analyzed due to poor accrual and insufficient numbers of participants.|||||
757283|NCT00607594|Secondary|Association Between Correlative Markers and Clinical Outcomes|Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible.|At baseline, 6 months, and then at 1 year||||||
757284|NCT00607594|Secondary|Tolerability|Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible.|Weekly during treatment||||||
757285|NCT00607594|Secondary|Safety|Toxicities will be graded using the National Cancer Institute (NCI) Common Toxicity Criteria Version 3.0.|Weekly during treatment||||||
757286|NCT00607594|Secondary|Overall Survival|The Kaplan-Meier method will be used to estimate overall and time to progression estimates. Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible.|Up to 1 year (median, 6 months, and 1 year)||||||
757287|NCT00607594|Secondary|Median Survival|Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible.|Up to 1 year|||months||95% Confidence Interval|Median
757288|NCT00607594|Secondary|Progression-free Survival|Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible.|Measured from the date of enrollment to progression, death or last contact, or last tumor assessment before the start of further anti-tumor therapy||||||
757289|NCT00607594|Secondary|Time to Progression|The Kaplan-Meier method will be used to estimate overall and time to progression estimates. Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible.|Up to 1 year (median, 6 month, 1-year)|||months||95% Confidence Interval|Median
757290|NCT00607594|Primary|Prolonged Stable Disease Rate (Defined as Stable Disease for ≥ 16 Weeks)||Every 2 weeks for the first 4 weeks, and then every 4-8 weeks thereafter|||participants|||Number
757291|NCT00607594|Primary|Objective Tumor Response (Defined as Partial [PR] or Complete Response [CR] by RECIST Criteria)|PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. CR is defined as disappearance of all non-target lesions and normalization of tumor marker level.|Every 2 weeks for the first 4 weeks, and then every 4-8 weeks thereafter|||participants|||Number
757292|NCT00607672|Primary|Interleukin-10 (IL-10) Response|To compare the effects of AT1 receptor antagonism or ACE inhibition versus placebo on the inflammatory response to CPB as measured by the IL-10 response|From the start of surgery until postoperative day 2|||pg/mL||Standard Error|Mean
757293|NCT00607672|Primary|Interleukin-8 (IL-8) Response|To compare the effects of AT1 receptor antagonism or ACE inhibition versus placebo on the inflammatory response to CPB as measured by IL-8|From the start of surgery until postoperative day 2|||pg/mL||Standard Error|Mean
757294|NCT00607672|Primary|Interleukin-6 (IL-6) Response|To compare the effects of AT1 receptor antagonism or ACE inhibition versus placebo on the inflammatory response to CPB as measured by IL-6|From the start of surgery until postoperative day 2|||pg/mL||Standard Error|Mean
757295|NCT00607672|Secondary|Length of Hospital Stay||From the start of surgery until discharge from hospital|||days||Standard Error|Mean
757296|NCT00607672|Secondary|Stroke|New onset neurological deficit with a duration of longer than 24 hours|From arrival in intensive care unit until discharge from hospital|||percentage of patients|||Number
757304|NCT00607672|Primary|Tissue-type Plasminogen Activator (t-PA) Antigen Response|To compare the effects of angiotensin II type I (AT1) receptor antagonism or angiotensin-converting enzyme (ACE) inhibition versus placebo on the fibrinolytic responses to cardiopulmonary bypass (CPB) as measured by t-PA antigen response|From the start of surgery until postoperative day 2|||ng/mL||Standard Error|Mean
757305|NCT00607724|Secondary|PFS: Participants With BCC|PFS was defined as the time from first dose of GDC-0449 to documented disease progression (deterioration of evaluable lesions and/or tumor-related symptoms defined using RECIST v1.0) or death from any cause within 30 days of the last dose of GDC-0449, whichever occurred first.|Screening, at Week 8 thereafter every 8 weeks, up to Week 116|Efficacy-evaluable population; only participants with BCC were included in the analysis. Number of participants censored for Stage 1+Stage 2 150 mg, and Stage 1+Stage 2 270 mg were 8 and 7 subjects, respectively, and no subject censored from Stage 1 540 mg group.||months||95% Confidence Interval|Median
757306|NCT00607724|Secondary|Progression-Free Survival (PFS): All Participants|PFS was defined as the time from first dose of GDC-0449 to documented disease progression (deterioration of evaluable lesions and/or tumor-related symptoms defined using RECIST v1.0) or death from any cause within 30 days of the last dose of GDC-0449, whichever occurred first.|Screening, at Week 8 thereafter every 8 weeks, up to Week 116|Efficacy-evaluable population. Number of participants censored for Stage 1 150 mg, 270 mg, and 540 mg were 1, 2, and 1 subjects, respectively and for Stage 2 BCC 150 mg, 270 mg, Stage 2 Safety Expansion Cohort 150 mg, and Stage 2 New Formulation 150 mg were 2, 6, 1, and 6 subjects, respectively.||months||95% Confidence Interval|Median
757307|NCT00607724|Secondary|Duration of Objective Response: Participants With BCC|Duration of response during first line therapy is defined as the time from when response (CR or PR) was first documented to first documented disease progression or death (whichever occurs first) during first line therapy. This was only calculated for participants who achieved a best overall response of CR or PR. Participants who did not progress or die after they had a confirmed response were censored at the date of their last tumor measurement or last follow-up for progression of disease during first line therapy.|Screening, at Week 8 thereafter every 8 weeks, up to Week 116|Efficacy-evaluable participants; only participants with BCC who achieved a best overall response of CR or PR were included in the analysis.||months||Full Range|Median
757308|NCT00607724|Secondary|Duration of Objective Response: All Participants|Duration of response during first line therapy is defined as the time from when response (CR or PR) was first documented to first documented disease progression or death (whichever occurs first) during first line therapy. This was only calculated for participants who achieved a best overall response of CR or PR. Participants who did not progress or die after they had a confirmed response were censored at the date of their last tumor measurement or last follow-up for progression of disease during first line therapy.|Screening, at Week 8 thereafter every 8 weeks, up to Week 116|Efficacy-evaluable population; only participants who achieved a best overall response of CR or PR were included in the analysis.||months||95% Confidence Interval|Median
757309|NCT00607724|Secondary|Percentage of Participants With a BOR of CR or PR: Participants With Basal Cell Carcinoma|BOR was defined as the best objective response observed during the treatment period according to RECIST v1.0. CR: disappearance of all TLs, with any pathological lymph nodes (whether target or non-target) having a reduction in short axis to less than 10 mm. PR: at least a 30% decrease in the sum of diameters of TLs, taking as reference the BL sum diameters.|Screening, at Week 8 thereafter every 8 weeks, up to Week 116|Efficacy-evaluable population; only participants with BCC were included in the analysis.||percentage of participants|||Number
757310|NCT00607724|Secondary|Percentage of Participants With a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR): All Participants|BOR was defined as the best objective response (complete or partial response determined by two consecutive investigator assessments which were at least 28 days apart) observed during the treatment period according to RECIST v1.0. CR: disappearance of all target lesions (TLs), with any pathological lymph nodes (whether target or non-target) having a reduction in short axis to less than 10 millimeters (mm). PR: at least a 30 percent (%) decrease in the sum of diameters of TLs, taking as reference the baseline (BL) sum diameters.|Screening, at Week 8 thereafter every 8 weeks, up to Week 116|Efficacy-evaluable population were those with measurable disease at baseline and who received at least 1 dose of GDC-0449 and either had a post-baseline tumor assessment or progressed before any tumor assessment.||percentage of participants|||Number
757311|NCT00607724|Secondary|Percentage of Participants With a Greater Than (>) 2-Fold Down-Modulation of GLI1 Expression in Skin Biopsy-Derived or Hair Follicle-Derived Messenger Ribonucleic Acid (mRNA)|Ribonucleic acid (RNA) was extracted from biopsy specimens of noninvolved skin or hair follicles at baseline and at 7 and 21 days after the start of daily drug therapy. Control mRNA was obtained from formalin-fixed, paraffin-embedded samples of normal skin and hair follicles from participants who were not enrolled in the study.|Baseline up to Day 29|"Pharmacodynamic-evaluable population included participants who had hair and/or skin samples available from Day 1 and at least one post-baseline sample while on study treatment. Here number of participants analyzed = participants evaluable for this measure and n= participants evaluable for the specific category."||percentage of participants|||Number
757312|NCT00607724|Primary|Accumulation Index (AI) After Multiple Doses of GDC-0449|AI was calculated using the formula [AI = AUC(0-24) on Day 15/AUC(0-24) on Day 1]. AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. AI was estimated if there were extensive PK sampling in more that 50% of the participants to form a curve.|-5 minutes (pre-dose), 0.5,1,2,4,8 hours post-dose on Day [D] 1; 2,3,4; -5 minutes (pre-dose) on D8,15,22,29,36,64,92,120,148,176,204,232,260,288,316,344;every 4 weeks after D345; end of treatment and study (up to 28 days after last dose), up to 2 years|AI was not reported as there were <50% participants with extensive PK sampling and the PK profiles were flat over 24 hours at steady state which did not allow estimation of AI.|||||
757313|NCT00607724|Primary|AUC0-24 After Multiple Doses of GDC-0449|AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. AUC was estimated if there were extensive PK sampling in more that 50% of the participants to form a curve.|-5 minutes (pre-dose), 0.5,1,2,4,8 hours post-dose on Day [D] 1; 2,3,4; -5 minutes (pre-dose) on D8,15,22,29,36,64,92,120,148,176,204,232,260,288,316,344;every 4 weeks after D345; end of treatment and study (up to 28 days after last dose), up to 2 years|AUC0-24 was not reported as there were <50% participants with extensive PK sampling and the PK profiles were flat over 24 hours at steady state which did not allow estimation of AUC0-24.|||||
757314|NCT00607724|Primary|Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24) After a Single Dose of GDC-0449|AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. Phase I comprised of two stages, a dose-escalation stage with the goal of estimating the maximum tolerated dose (Stage 1), and an expanded cohort to collect additional safety, PK, and PD data at the proposed Phase II dose (Stage 2). Phase II represented the additional cohort initiated with 150 mg hard gelatin capsule identified from the safety, PK and PD data from Stage 1 of the trial.|-5 minutes (pre-dose) and 0.5, 1, 2, 4, 8, 24 hours post-dose on Day 1; additionally for stage 1 arms: 48 hours (Day 3), 72 hours (Day 4) post-dose and – 5 minutes (pre-dose) on Day 8|PK-evaluable population.||mcM*day||Standard Deviation|Mean
757315|NCT00607724|Primary|Average Plasma Concentration at Steady State (Css, Avg) After Multiple Doses of GDC-0449|Steady state GDC−0449 plasma concentrations (Css) were calculated as an average of plasma concentrations from Study Day 21 (Stage 2) or Study Day 28 (Stage 1) onward.|-5 minutes (pre-dose), 0.5,1,2,4,8 hours post-dose on Day [D] 1; 2,3,4; -5 minutes (pre-dose) on D8,15,22,29,36,64,92,120,148,176,204,232,260,288,316,344;every 4 weeks after D345; end of treatment and study (up to 28 days after last dose), up to 2 years|"PK-evaluable population. Here number of participants analyzed = participants evaluable for this measure."||mcM||Standard Deviation|Mean
757316|NCT00607724|Primary|Tmax After Multiple Doses of GDC-0449|Tmax was estimated if there were extensive PK sampling in more that 50% of the participants to form a curve.|-5 minutes (pre-dose), 0.5,1,2,4,8 hours post-dose on Day [D] 1; 2,3,4; -5 minutes (pre-dose) on D8,15,22,29,36,64,92,120,148,176,204,232,260,288,316,344;every 4 weeks after D345; end of treatment and study (up to 28 days after last dose), up to 2 years|Cmax was not reported as there were <50% participants with extensive PK sampling and the PK profiles were flat over 24 hours at steady state which did not allow estimation of Cmax, and as Tmax was related to Cmax, it was also not estimated.|||||
757317|NCT00607724|Primary|Time to Maximum Plasma Concentration (Tmax) After a Single Dose of GDC-0449|Phase I comprised of two stages, a dose-escalation stage with the goal of estimating the maximum tolerated dose (Stage 1), and an expanded cohort to collect additional safety, PK, and PD data at the proposed Phase II dose (Stage 2). Phase II represented the additional cohort initiated with 150 mg hard gelatin capsule identified from the safety, PK and PD data from Stage 1 of the trial.|-5 minutes (pre-dose) and 0.5, 1, 2, 4, 8, 24 hours post-dose on Day 1; additionally for stage 1 arms: 48 hours (Day 3), 72 hours (Day 4) post-dose and – 5 minutes (pre-dose) on Day 8|PK-evaluable population.||days||Full Range|Median
757318|NCT00607724|Primary|Cmax After Multiple Doses of GDC-0449|Cmax was estimated if there were extensive PK sampling in more that 50% of the participants to form a curve.|-5 minutes (pre-dose), 0.5,1,2,4,8 hours post-dose on Day [D] 1; 2,3,4; -5 minutes (pre-dose) on D8,15,22,29,36,64,92,120,148,176,204,232,260,288,316,344;every 4 weeks after D345; end of treatment and study (up to 28 days after last dose), up to 2 years|Cmax was not reported as there were <50% participants with extensive PK sampling and the PK profiles were flat over 24 hours at steady state which did not allow estimation of Cmax.|||||
757319|NCT00607724|Primary|Maximum Observed Plasma Concentration (Cmax) After a Single Dose of GDC-0449|Phase I comprised of two stages, a dose-escalation stage with the goal of estimating the maximum tolerated dose (Stage 1), and an expanded cohort to collect additional safety, PK, and pharmacodynamic (PD) data at the proposed Phase II dose (Stage 2). Phase II represented the additional cohort initiated with 150 mg hard gelatin capsule identified from the safety, PK and PD data from Stage 1 of the trial.|-5 minutes (pre-dose) and 0.5, 1, 2, 4, 8, 24 hours post-dose on Day 1; additionally for stage 1 arms: 48 hours (Day 3), 72 hours (Day 4) post-dose and – 5 minutes (pre-dose) on Day 8|Pharmacokinetic (PK)-evaluable population included participants who had at least Day 1 PK samples available.||micromolar (mcM)||Standard Deviation|Mean
757320|NCT00607724|Primary|Percentage of Participants With Dose-Limiting Toxicities (DLTs)|A DLT was defined as any Grade 3 or 4 hematologic or major organ toxicity as graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (Version 3.0) that occurred during the first 35 days after the initiation of study drug (Days 1−35) and was attributable to GDC-0449.|Up to Week 6|Safety-evaluable population.||percentage of participants|||Number
757321|NCT00607789|Secondary|Weekly Episodes|The weekly frequency of binge episodes after baseline (number of binge eating days during the 12-week period divided by 7)|12 weeks|The secondary efficacy analysis was a longitudinal analysis comparing the rate of change of binge weeks frequency during the treatment period between groups.||Days||Standard Deviation|Mean
757322|NCT00607789|Primary|Binge Eating Days|The mean number of binge days (days when the participant had one or more binge eating episodes) per week in the interval between visits (total number of binge days in the interval divided by number of days in the interval, then multiplied by 7).|12 weeks|The primary efficacy analysis was a longitudinal analysis comparing the rate of change of binge day frequency during the treatment period between groups.||Mean Number of days||Standard Deviation|Mean
757323|NCT00607815|Secondary|State-Trait Anxiety Scale|Self-reported state anxiety; higher is worse; scale score is summed; range at post-treatment is 20-73.|post-treatment, at 3 months and 1 year|||units on a scale||Standard Deviation|Mean
757324|NCT00607815|Secondary|State-Trait Anger Scale (STAXI)|Self-reported trait anger; subscale score is summed; higher is worse; range at post-treatment is 10-37.|post-treatment, at 3 months and 1 year|||units on a scale||Standard Deviation|Mean
757325|NCT00607815|Secondary|Beck Depression Inventory - II (BDI-II)|Gold-standard, self-reported depression severity measure; higher is worse; post-treatment range is 2-45. scale scores are summed.|post-treatment, at 3 months and 1 year|||units on a scale||Standard Deviation|Mean
757326|NCT00607815|Primary|PTSD Checklist (PCL)|17-item patient self-reported PTSD severity; higher is worse; range at post-treatment is 17-73; scale scores are summed|post-treatment, at 3 months and 1 year|||units on a scale||Standard Deviation|Mean
757327|NCT00607815|Primary|Clinician Administered PTSD Scale|Clinician-rated PTSD symptom severity; higher is worse; range at post-treatment is 0 to 80; scale scores are summed.|Post-treatment, at 3 months and 1 year|Generalized estimating equations (GEE) were used to test study hypotheses.||units on a scale||Standard Deviation|Mean
757328|NCT00607867|Secondary|Change in Fasting Triglycerides at 5 Weeks From Baseline|Overnight fasting triglycerides concentration was measured before dietary intervention and after 5 weeks of dietary intervention|baseline and 5 weeks after dietary intervention|||mg/dl||Standard Error|Mean
757330|NCT00607867|Primary|Change in Body Weight at 5 Weeks From Baseline|Subjects were to remain weight stable. We expected less than 2 pound weight change over 5 weeks. Weight was measured before dietary intervention, and after 5 weeks of dietary intervention.|baseline and 5 weeks after dietary intervention|||pounds||Standard Error|Mean
757331|NCT00607867|Primary|Change in Total Glucose Area at 5 Weeks From Baseline|The area response is measured using zero as baseline. The area is measured before dietary intervention, and following 5 weeks of dietary intervention.|Baseline and 5 weeks after dietary intervention|||mg hr/dl||Standard Error|Mean
757332|NCT00607867|Secondary|Microalbumin Excretion|change in urinary albumin excretion was measured before dietary intervention and after 5 weeks of dietary intervention|baseline and 5 weeks after dietary intervention|||mg/day||Standard Error|Mean
757333|NCT00607867|Primary|Change in %Hemoglobin A1c at 5 Weeks From Baseline|Hemoglobin A1c measured before and after 5 weeks on the diet|Baseline and 5 weeks after dietary intervention|||Change in % A1c at 5 weeks from baseli||Standard Error|Mean
757334|NCT00607880|Secondary|Termination of Use of the Indwelling Port at 12 Months After Port Insertion|The number of patients that discontinued use of inserted port for any reason at the 12 month timepoint.|Up to 12 months after port insertion|||participants|||Number
757335|NCT00607880|Secondary|Port Removal for Any Reason Other Than Infection or Occlusion Within 12 Months After Port Insertion|We report the number of patients that terminated use of port due to any reason other than infection or occlusion within 12 months.|Up to 12 months after port insertion|All patients accrued to this study that had their port removed within12 months for any reason other than infection/occlusion were included in this analysis. 28 patients using the Standard Access Port and 30 patients using the Vortex Implantable Access Port had port removal prior to 12 months due to reasons other than infection or occlusion..||participants|||Number
757336|NCT00607880|Secondary|Death From All Causes|Number of patients that died during treatment due to any cause.|Up to 12 months after port insertion|||participants|||Number
757337|NCT00607880|Primary|Port Failure Within 12 Months of Port Insertion|We report the proportion of patients in each treatment group who have some degree of port failure. Port failure is defined as the composite outcome of port malfunction due to partial or total occlusion and any infection related to the port, within 12 months of port insertion. The percentages reported here are the number of patients that had reported a port failure within 12 months out of the number of patients with port failure within 12 months plus the number of patients that were followed 12 months without port failure.|Up to 12 months from port insertion|Patients with port failure within 12 months and patients that were followed 12 months without port failure were included in this analysis.||percentage of patients||95% Confidence Interval|Number
757338|NCT00607893|Secondary|Augmentation Index, Morning|Pulse wave analysis outcome (a ratio of the augmentation of central aortic pressure by a reflected pulse wave, calculated from the blood pressure waveform), analyzed absolute change from baseline, with adjustment of baseline|Measured between Months 2 and 3 of treatment|||percent change||95% Confidence Interval|Least Squares Mean
757339|NCT00607893|Secondary|Augmentation Index, Evening|Pulse wave analysis outcome (a ratio of the augmentation of central aortic pressure by a reflected pulse wave, calculated from the blood pressure waveform), analyzed absolute change from baseline, with adjustment of baseline|Measured between Months 2 and 3 of treatment|||percent change||95% Confidence Interval|Least Squares Mean
757340|NCT00607893|Secondary|Pulse Wave Velocity, Morning|Pulse wave analysis outcome, analyzed absolute change from baseline, with adjustment of baseline|Measured between Months 2 and 3 of treatment|||cm/s||95% Confidence Interval|Least Squares Mean
757341|NCT00607893|Secondary|sIL-6R|Measures of inflammation outcome, logarithm transformed before analysis due to skewed distribution, analyzed change of from baseline with adjustment of baseline. The least squares mean is transformed back to present the percent change from baseline.|Measured between baseline and after treatment|||percent change||95% Confidence Interval|Least Squares Mean
757342|NCT00607893|Secondary|Mean Arterial BP, Morning|Blood pressure outcome, analyzed absolute change from baseline, with adjustment of baseline|Measured between baseline and after treatment|||mm Hg||95% Confidence Interval|Least Squares Mean
757343|NCT00607893|Secondary|IL-6|Measures of inflammation outcome, analyzed absolute change from baseline, with adjustment of baseline|Measured between baseline and after treatment|||pg/mL||95% Confidence Interval|Least Squares Mean
757344|NCT00607893|Secondary|Pulse Wave Velocity, Evening|Pulse wave analysis outcome, analyzed absolute change from baseline, with adjustment of baseline|Measured between baseline and after treatment|||cm/s||95% Confidence Interval|Least Squares Mean
757345|NCT00607893|Secondary|Mean Arterial BP, Evening|Blood pressure outcome, analyzed absolute change from baseline, with adjustment of baseline|Measured between baseline and after treatment|||mm Hg||95% Confidence Interval|Least Squares Mean
757346|NCT00607893|Primary|Myeloperoxidase|Oxidative stress outcome, analyzed absolute change from baseline, with adjustment of baseline|Measured between baseline and after treatment|||pmol/L||95% Confidence Interval|Least Squares Mean
757347|NCT00607893|Primary|F2-isoprostanes/Cr|Oxidative stress outcome, analyzed absolute change from baseline, with adjustment of baseline|Measured between baseline and after treatment|||ng/mg||95% Confidence Interval|Least Squares Mean
757348|NCT00607919|Secondary|Change From Baseline in Multidimensional Self Concept Scale (MSCS) at Week 32 Endpoint|The MSCS is an overall assessment of self concept or an individual measure of any of the six scaled dimensions of self concept: Social, Competence, Affect, Academic, Family, and Physical. Standard scores range from 45-145. Higher scores are better (indicate higher self concept).|Baseline, 32 weeks|All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
757349|NCT00607919|Secondary|Change From Baseline in Kiddie Sluggish Cognitive Tempo (K-SCT) at Week 32 Endpoint|The K-SCT rating scale contains 3 components: Youth, Parent, and Teacher ratings. It queries 17 candidate SCT symptoms, such as daydreams, lost in a fog, sluggish/drowsy. Scores range from 0-51. Lower scores indicate less sluggish.|Baseline, 32 weeks|All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
757460|NCT00608491|Secondary|Best Available Glomerular Filtration Rate Change|Core laboratory when available. If not available, local laboratory results were used.|Baseline to Day 60|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mL/min||Standard Deviation|Mean
757350|NCT00607919|Secondary|Change From Baseline in Life Participation Scale-child (LPS-C) Score at Week 32 Endpoint|LPS-C is a short (24 item, 0-3 points per item) parent-rated scale that is designed to assess changes in adaptive functioning related to treatment for ADHD. This scale measures improvements in social, emotional, cognitive, educational, and affiliative (family, friends) functioning, which indirectly reflect improvements in executive functioning. Happy/social subscores range from 0-18, and self-control subscores range from 0-54. Total scores range from 0-72. Higher scores are better for LPS.|Baseline, 32 weeks|All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
757351|NCT00607919|Secondary|Change From Baseline in Working Memory Test Battery for Children (WMTB-C) at Week 32 Endpoint|WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory).|Baseline, 32 weeks|All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
757352|NCT00607919|Secondary|Change From Baseline in Test of Word Reading Efficiency (TOWRE) at Week 32 Endpoint|The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. Scores range from 45-146. Higher scores indicate higher reading proficiency.|Baseline, 32 weeks|All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
757353|NCT00607919|Secondary|Change From Baseline in Gray Oral Reading Test-4 (GORT-4) at Week 32 Endpoint|The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills.|Baseline, 32 weeks|All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
757354|NCT00607919|Secondary|Change From Baseline in Comprehensive Test of Phonological Processing (CTOPP) at Week 32 Endpoint|The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better.|Baseline, 32 weeks|All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
757355|NCT00607919|Secondary|Change From Baseline in Woodcock-Johnson III Scores at Week 32 Endpoint|The Woodcock Johnson Tests of Achievement has a Standard Battery (Tests 1-12) of a broad set of scores and an Extended Battery (Tests 13-22) on specific academic strengths and weaknesses. Tests associated with reading skills (1, 2, 7, 9, 13, 17, 20) were administered. Scores for each individual test can range from 0 to over 200 where anything 69 and below is very low and anything 131 and above is very superior. Higher scores indicate better reading skills.|Baseline, 32 weeks|All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
757356|NCT00607919|Secondary|Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Teacher Version at Week 32 Endpoint|The ADHDRS-IV-Teacher is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3 =severe (very often). Hyperactivity-impulsivity scores range from 0-27, and inattention scores range from 0-27. Total scores range from 0-54. Higher scores indicate higher impairment.|Baseline, 32 weeks|All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).||units||Standard Deviation|Mean
757357|NCT00607919|Secondary|Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Parent Version at Week 32 Endpoint|The ADHDRS-IV-parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3 =severe (very often). Hyperactivity-impulsivity scores range from 0-27, and inattention scores range from 0-27. Total scores range from 0-54. Higher scores indicate higher impairment.|Baseline, 32 weeks|All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
757358|NCT00607919|Secondary|Change From Baseline in Multidimensional Self Concept Scale (MSCS) at Week 16 Endpoint|The MSCS is an overall assessment of self concept or an individual measure of any of the six scaled dimensions of self concept: Social, Competence, Affect, Academic, Family, and Physical. Standard scores range from 45-145. Higher scores are better (indicate higher self concept).|Baseline, 16 weeks|All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
757461|NCT00608491|Secondary|Best Available Serum Creatinine Change|Core laboratory when available. If not available, local laboratory results were used.|Baseline to Day 60|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mg/dL||Standard Deviation|Mean
757359|NCT00607919|Secondary|Change From Baseline in Kiddie Sluggish Cognitive Tempo (K-SCT) at Week 16 Endpoint|The K-SCT rating scale contains 3 components: Youth, Parent, and Teacher ratings. It queries 17 candidate SCT symptoms, such as daydreams, lost in a fog, sluggish/drowsy. Scores range from 0-51. Lower scores indicate less sluggish.|Baseline, 16 weeks|All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
757360|NCT00607919|Secondary|Change From Baseline in Life Participation Scale-child (LPS-C) Score at Week 16 Endpoint|LPS-C is a short (24 item, 0-3 points per item) parent-rated scale that is designed to assess changes in adaptive functioning related to treatment for ADHD. This scale measures improvements in social, emotional, cognitive, educational, and affiliative (family, friends) functioning, which indirectly reflect improvements in executive functioning. Happy/social subscores range from 0-18, and self-control subscores range from 0-54. Total scores range from 0-72. Higher scores are better for LPS.|Baseline, 16 weeks|All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
757361|NCT00607919|Secondary|Change From Baseline in Working Memory Test Battery for Children (WMTB-C) at Week 16 Endpoint|WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory).|Baseline, 16 weeks|All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
757362|NCT00607919|Secondary|Change From Baseline in Test of Word Reading Efficiency (TOWRE) at Week 16 Endpoint|The TOWRE is a measure of an individual’s ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. Scores range from 45-146. Higher scores indicate higher reading proficiency.|Baseline, 16 weeks|All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
757363|NCT00607919|Secondary|Change From Baseline in Gray Oral Reading Test-4 (GORT-4) at Week 16 Endpoint|The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32–Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills.|Baseline, 16 weeks|All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
757364|NCT00607919|Secondary|Change From Baseline in Comprehensive Test of Phonological Processing (CTOPP) at Week 16 Endpoint|The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better.|Baseline, 16 weeks|All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
757365|NCT00607919|Secondary|Change From Baseline in Woodcock-Johnson III Scores at Week 16 Endpoint|The Woodcock Johnson Tests of Achievement has a Standard Battery (Tests 1-12) of a broad set of scores and an Extended Battery (Tests 13-22) on specific academic strengths and weaknesses. Tests associated with reading skills (1, 2, 7, 9, 13, 17, 20) were administered. Scores for each individual test can range from 0 to over 200 where anything 69 and below is very low and anything 131 and above is very superior. Higher scores indicate better reading skills.|Baseline, 16 weeks|All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
757366|NCT00607919|Secondary|Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Teacher Version at Week 16 Endpoint|The ADHDRS-IV-Teacher is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Hyperactivity-impulsivity scores range from 0-27, and inattention scores range from 0-27. Total scores range from 0-54. Higher scores indicate higher impairment.|Baseline, 16 weeks|All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
757367|NCT00607919|Secondary|Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Parent Version at Week 16 Endpoint|The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Hyperactivity-impulsivity scores range 0-27, and inattention scores range 0-27. Total scores range from 0-54. Higher scores indicate higher impairment.|Baseline, 16 weeks|All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
757398|NCT00608205|Secondary|Solid Foods|"Quality of life questionnaire asking I can eat solid foods.
The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|12 weeks (after treatment)|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||units on a scale||Standard Deviation|Mean
757368|NCT00607919|Primary|Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total Score - Parent Version at Week 16 Endpoint|Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD). Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0-54. Least Square mean of change from baseline in ADHDRS is from a restricted maximum likelihood-based, mixed model repeated measures analysis which includes the effects of treatment, investigative site, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.|Baseline, 16 weeks|All randomized participants with a baseline and at least one post-baseline result.||units on a scale||Standard Error|Least Squares Mean
757369|NCT00607997|Secondary|Pharmacokinetics Day 4 - Vss (L)|"Pharmacokinetic Parameters (Vss ) by Schedule, Dosing Day, and Dose Cohort for Patients Treated With Vosaroxin as a Single Agent (SPO 0014) for Day 4
Numbers reported are N, mean and CV%. Please note CV% is not a choice that can be entered from the drop down menu. The standard deviation is really CV% in the table."|Day 4|Patients Treated with Vosaroxin as a Single Agent (SPO-0014) on Day 4. Of 113 patients treated, PK data were available for 33 patients who received at least 1 dose of vosaroxin, PK profiles were evaluated for patients with data for Day 4, for 5 patients in Schedule C, and for 7 patients in Schedule C.||L||Standard Deviation|Mean
757370|NCT00607997|Secondary|Pharmacokinetics Day 4 - CL (L/hr)|"Pharmacokinetic Parameters (CL) by Schedule, Dosing Day, and Dose Cohort for Patients Treated With Vosaroxin as a Single Agent (SPO 0014) for Day 4
Numbers reported are N, mean and CV%. Please note CV% is not a choice that can be entered from the drop down menu. The standard deviation is really CV% in the table."|Day 4|Patients Treated with Vosaroxin as a Single Agent (SPO-0014) on Day 4. Of 113 patients treated, PK data were available for 33 patients who received at least 1 dose of vosaroxin, PK profiles were evaluated for patients with data on Day 4, for 5 patients in Schedule C, and for 7 patients in Schedule C.||L/hr||Standard Deviation|Mean
757371|NCT00607997|Secondary|Pharmacokinetics Day 4 - t1/2 (hr) and MRTinf (hr)|"Pharmacokinetic Parameters (t1/2 and and MRTinf) by Schedule, Dosing Day, and Dose Cohort for Patients Treated With Vosaroxin as a Single Agent (SPO 0014) for Day 4
Numbers reported are N, mean and CV%. Please note CV% is not a choice that can be entered from the drop down menu. The Standard Deviation is really CV% in the table."|Day 4|Patients Treated with Vosaroxin as a Single Agent (SPO-0014) on Day 4. Of 113 patients treated, PK data were available for 33 patients who received at least 1 dose of vosaroxin, PK profiles were evaluated for patients with data, for 5 patients in Schedule C, and for 7 patients in Schedule C.||hr||Standard Deviation|Mean
757372|NCT00607997|Secondary|Pharmacokinetics Day 4 - AUC0-72 and AUCinf (hr*ng/mL)|"Pharmacokinetic Parameters (AUC0-72 and AUCinf ) by Schedule, Dosing Day, and Dose Cohort for Patients Treated With Vosaroxin as a Single Agent (SPO 0014) for Day 4
Numbers reported are N, mean and CV%. Please note CV% is not a choice that can be entered from the drop down menu. Standard Deviation is really CV% in the table."|Day 4|Patients Treated with Vosaroxin as a Single Agent (SPO-0014) on Day 4. Of 113 patients treated, PK data were available for 33 patients who received at least 1 dose of vosaroxin, PK profiles were evaluated for patients with data on Day 4, for 5 patients in Schedule C, and for 8 patients in Schedule C.||hr*ng/mL||Standard Deviation|Mean
757373|NCT00607997|Secondary|Pharmacokinetics Day 1 - Vss (L)|"Pharmacokinetic Parameters (Vss ) by Schedule, Dosing Day, and Dose Cohort for Patients Treated With Vosaroxin as a Single Agent (SPO 0014) for Day 1
Numbers reported are N, mean and CV%. Please note CV% is not a choice that can be entered from the drop down menu. The standard deviation is really CV% in the table."|1 Day|Patients Treated with Vosaroxin as a Single Agent (SPO-0014) on Day 1. Of 113 patients treated, PK data were available for 33 patients who received at least 1 dose of vosaroxin, PK profiles were evaluated for 10 patients in Schedule A, for 8 patients in Schedule B, for 6 patients in Schedule C, and for 8 patients in Schedule C.||L||Standard Deviation|Mean
757374|NCT00607997|Secondary|Pharmacokinetics Day 1 - CL (L/hr)|"Pharmacokinetic Parameters (CL) by Schedule, Dosing Day, and Dose Cohort for Patients Treated With Vosaroxin as a Single Agent (SPO 0014) for Day 1
Numbers reported are N, mean and CV%. Please note CV% is not a choice that can be entered from the drop down menu. The standard deviation is really CV% in the table."|1 Day|Patients Treated with Vosaroxin as a Single Agent (SPO-0014) on Day 1. Of 113 patients treated, PK data were available for 33 patients who received at least 1 dose of vosaroxin, PK profiles were evaluated for 10 patients in Schedule A, for 8 patients in Schedule B, for 6 patients in Schedule C, and for 8 patients in Schedule C.||L/hr||Standard Deviation|Mean
757375|NCT00607997|Secondary|Pharmacokinetics Day 1 - t1/2 (hr) and MRTinf (hr)|"Pharmacokinetic Parameters (t1/2 and and MRTinf) by Schedule, Dosing Day, and Dose Cohort for Patients Treated With Vosaroxin as a Single Agent (SPO 0014) for Day 1
Numbers reported are N, mean and CV%. Please note CV% is not a choice that can be entered from the drop down menu. The standard deviation is really CV% in the table."|1 Day|Patients Treated with Vosaroxin as a Single Agent (SPO-0014) on Day 1. Of 113 patients treated, PK data were available for 33 patients who received at least 1 dose of vosaroxin, PK profiles were evaluated for 10 patients in Schedule A, for 8 patients in Schedule B, for 6 patients in Schedule C, and for 8 patients in Schedule C.||hr||Standard Deviation|Mean
757376|NCT00607997|Secondary|Pharmacokinetics Day 1 - AUC0-72 and AUCinf (hr*ng/mL)|"Pharmacokinetic Parameters (AUC0-72 and AUCinf ) by Schedule, Dosing Day, and Dose Cohort for Patients Treated With Vosaroxin as a Single Agent (SPO 0014) for Day 1
Numbers reported are N, mean and CV%. Please note CV% is not a choice that can be entered from the drop down menu. The standard deviation is really CV% in the table."|1 Day|Patients Treated with Vosaroxin as a Single Agent (SPO-0014) on Day 1. Of 113 patients treated, PK data were available for 33 patients who received at least 1 dose of vosaroxin, PK profiles were evaluated for 10 patients in Schedule A, for 9 patients in Schedule B, for 6 patients in Schedule C, and for 8 patients in Schedule C.||hr*ng/mL||Standard Deviation|Mean
757377|NCT00607997|Secondary|All Cause Mortality|Mortality of those patients enrolled in the study and receiving intervention|30 and 60 days|All treated analysis set||Participants|||Count of Participants
757399|NCT00608205|Secondary|Alcohol Consumption|"Quality of life questionnaire asking I drink alcohol (e.g. beer, wine).
The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|24 months after start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||units on a scale||Standard Deviation|Mean
757378|NCT00607997|Secondary|Pharmacokinetics Day 4 Cmax (ng/mL)|"Pharmacokinetic Parameters by Schedule, Dosing Day, and Dose Cohort for Patients Treated With Vosaroxin as a Single Agent (SPO 0014) on Day 4
Please note that N, mean and CV% are reported, but CV% is not an option in the drop down menu. So Standard Deviation is really CV% in the table."|Day 4|Patients Treated with Vosaroxin as a Single Agent (SPO-0014) Day 4. Of 113 patients treated, PK data were available for 33 patients who received at least 1 dose of vosaroxin, PK profiles were evaluated for patients with data on Day 4 for 5 patients in Schedule C, and for 8 patients in Schedule C .||ng/mL||Standard Deviation|Mean
757379|NCT00607997|Secondary|Pharmacokinetics Day 1 - Cmax (ng/mL)|"Pharmacokinetic Parameters (Cmax) by Schedule, Dosing Day, and Dose Cohort for Patients Treated With Vosaroxin as a Single Agent (SPO 0014) for Day 1
Numbers reported are N, mean and CV%. Please note CV% is not a choice that can be entered from the drop down menu. The standard deviation is really CV% in the table."|1 Day|Patients Treated with Vosaroxin as a Single Agent (SPO-0014) on Day 1. Of 113 patients treated, PK data were available for 33 patients who received at least 1 dose of vosaroxin, PK profiles were evaluated for 10 patients in Schedule A, for 9 patients in Schedule B, for 6 patients in Schedule C, and for 8 patients in Schedule C.||ng/mL||Standard Deviation|Mean
757380|NCT00607997|Secondary|Overall Survival||2 years|All treated patients||Months||95% Confidence Interval|Median
757381|NCT00607997|Secondary|Leukemia-free Survival (LFS)|The censor date was the last known alive date without report of relapse.|2 years|All treated analysis set||Months||95% Confidence Interval|Median
757382|NCT00607997|Primary|Remission Rate Defined as the Percentage of Patients Whose Respnse is CR or CRp Based on International Working Group (IWG) Response Criteria and Treatment Outcomes Definitions|"Combined remission rate (complete remission [CR] + complete remission with incomplete platelet recovery [CRp]) of vosaroxin of patients ≥ 60 years old with previously untreated (de novo or secondary) AML are presented by treatment group for all treated analysis set.
Per IWG criteria, a CR requires bone marrow blasts < 5%, absolute neutrophil count (ANC) > 1000 cells/uL, and platelet (plt) count > 100,000 plt/uL. The criteria for CRp are the same as those for CR, except for platelet count <= 100,000 lt/uL. Investigators were to determine a response category for each patient by examination of bone marrow and blood counts at the time of hematologic recovery after induction or reinduction. Investigator assessment categories included CR, CRp, CRi (Morphologic CR with incomplete blood count recovery), PR (partial remission), treatment failure, and relapse."|2 years|The all treated analysis set Included all enrolled patients who received any amount of vosaroxin.||percentage of patients||95% Confidence Interval|Number
757383|NCT00608023|Primary|Changes From Baseline in 2 h Oral Glucose Tolerance Test (OGTT) at Week 52|Glucose tolerance was determined after an overnight fast using standard 75 gram-oral glucose tolerance test (OGTT) with glucose measured at timepoints 0, 30, 60, 90 and 120. Changes in glucose tolerance between baseline and Week 52 are reported.|Baseline and Week 52|||mg/dL||Standard Deviation|Mean
757384|NCT00608023|Primary|Changes From Baseline in Fasting Blood Glucose at Week 52|Blood glucose was determined after an overnight fast. Changes in blood glucose between baseline and Week 52 are reported.|Baseline and Week 52|||mg/dL||Standard Deviation|Mean
757385|NCT00608023|Other Pre-specified|Changes From Baseline in Total Cholesterol/HDL Cholesterol Ratio at Week 52|Blood lipid levels were determined under fasting conditions. Total Cholesterol/HDL Cholesterol Ratio was obtained by dividing the total cholesterol value by the value of the HDL cholesterol. Changes between baseline and Week 52 are reported.|Baseline and Week 52|||ratio||Standard Deviation|Mean
757386|NCT00608023|Other Pre-specified|Changes From Baseline in Triglycerides at Week 52|Blood lipid levels were determined under fasting conditions. Changes in triglycerides between baseline and Week 52 are reported.|Baseline and Week 52|||mg/dL||Standard Deviation|Mean
757387|NCT00608023|Secondary|Changes From Baseline in Visceral Adipose Tissue (VAT) at Week 52|Visceral adipose tissue (VAT) was assessed by computerized tomography (CT) scan using a single-slice. Changes in VAT between baseline and Week 52 are reported.|Baseline and Week 52|All data were included in the analysis by intention to treat principles. Intent to treat populations were defined as all randomized subjects who were exposed to study drug (i.e injection of at least 1 dose of study drug).||cm^2||Standard Deviation|Mean
757388|NCT00608140|Secondary|Perioperative Mortality||Measured between Days 0 and 30 postsurgery|||participants|||Number
757389|NCT00608140|Secondary|Total Mortality (All Causes)||Measured at Month 18||||||
757390|NCT00608140|Secondary|Total Days Alive and Total Days Not Hospitalized||Measured at baseline and Month 18||||||
757391|NCT00608140|Secondary|Change in Minnesota Living With Heart Failure (MLHF) Score||Measured at baseline and Month 18||||||
757392|NCT00608140|Secondary|Change in 6-minute Walk Test||Measured at baseline and Month 18||||||
757393|NCT00608140|Secondary|Peak VO2||Measured at Month 18||||||
757394|NCT00608140|Primary|Effect of Adding SMVR to OMT Alone on LV Remodeling, Specifically LV End-systolic Volume Index (LVESVI)||Measured at Month 18|Data were not analyzed due to study termination|||||
757395|NCT00608205|Secondary|Solid Foods|"Quality of life questionnaire asking I can eat solid foods.
The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|24 months after start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||units on a scale||Standard Deviation|Mean
757396|NCT00608205|Secondary|Solid Foods|"Quality of life questionnaire asking I can eat solid foods.
The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|12 months after start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||units on a scale||Standard Deviation|Mean
757397|NCT00608205|Secondary|Solid Foods|"Quality of life questionnaire asking I can eat solid foods.
The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|8 months after start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||units on a scale||Standard Deviation|Mean
757455|NCT00608491|Secondary|Change in Blood High Sensitivity Troponin I||Baseline to Day 60|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||pg/mL||Standard Deviation|Mean
757400|NCT00608205|Secondary|Alcohol Consumption|"Quality of life questionnaire asking I drink alcohol (e.g. beer, wine).
The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|12 months after start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||units on a scale||Standard Deviation|Mean
757401|NCT00608205|Secondary|Alcohol Consumption|"Quality of life questionnaire asking I drink alcohol (e.g. beer, wine).
The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|8 months after start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||units on a scale||Standard Deviation|Mean
757402|NCT00608205|Secondary|Alcohol Consumption|"Quality of life questionnaire asking I drink alcohol (e.g. beer, wine).
The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|12 weeks (after treatment)|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||units on a scale||Standard Deviation|Mean
757403|NCT00608205|Secondary|Swallowing|"Quality of life questionnaire asking I can swallow naturally and easily.
The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|24 months after start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||units on a scale||Standard Deviation|Mean
757404|NCT00608205|Secondary|Swallowing|"Quality of life questionnaire asking I can swallow naturally and easily.
The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|12 months after start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||units on a scale||Standard Deviation|Mean
757405|NCT00608205|Secondary|Swallowing|"Quality of life questionnaire asking I can swallow naturally and easily.
The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|8 months after start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||units on a scale||Standard Deviation|Mean
757406|NCT00608205|Secondary|Swallowing|"Quality of life questionnaire asking I can swallow naturally and easily.
The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|12 weeks (after treatment)|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||units on a scale||Standard Deviation|Mean
757407|NCT00608205|Secondary|Eating|"Quality of life questionnaire asking I am able to eat the foods i like.
The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|24 months from start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||units on a scale||Standard Deviation|Mean
757408|NCT00608205|Secondary|Eating|"Quality of life questionnaire asking I am able to eat the foods i like.
The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|12 months from start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||units on a scale||Standard Deviation|Mean
757409|NCT00608205|Secondary|Eating|"Quality of life questionnaire asking I am able to eat the foods i like.
The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|8 months from start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||units on a scale||Standard Deviation|Mean
757410|NCT00608205|Secondary|Eating|"Quality of life questionnaire asking I am able to eat the foods i like.
The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|12 weeks (after treatment)|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||units on a scale||Standard Deviation|Mean
757411|NCT00608205|Secondary|Quality of Life|"Quality of life questionnaire asking I am content with the quality of my life right now.
The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|24 months from start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||units on a scale||Standard Deviation|Mean
757412|NCT00608205|Secondary|Quality of Life|"Quality of life questionnaire asking I am content with the quality of my life right now.
The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|12 months from start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||units on a scale||Standard Deviation|Mean
757413|NCT00608205|Secondary|Quality of Life|"Quality of life questionnaire asking I am content with the quality of my life right now.
The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|8 months from start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||units on a scale||Standard Deviation|Mean
757414|NCT00608205|Secondary|Quality of Life|"Quality of life questionnaire asking I am content with the quality of my life right now.
The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|12 weeks (after treatment)|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||units on a scale||Standard Deviation|Mean
786176|NCT00833690|Secondary|Change in Serum Urate|Change from an Average of Baseline and Screening Visits|Visit 02 from Baseline (i.e., between -45 days and +4 weeks)|||mg/dL||Standard Deviation|Mean
757415|NCT00608205|Secondary|Pain|"Quality of life questionnaire asking I have pain in my mouth, throat or neck.
The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|24 months from start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||units on a scale||Standard Deviation|Mean
757416|NCT00608205|Secondary|Pain|"Quality of life questionnaire asking I have pain in my mouth, throat or neck.
The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|12 months from start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||units on a scale||Standard Deviation|Mean
757417|NCT00608205|Secondary|Pain|"Quality of life questionnaire asking I have pain in my mouth, throat or neck.
The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|8 months from start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||units on a scale||Standard Deviation|Mean
757418|NCT00608205|Secondary|Pain|"Quality of life questionnaire asking I have pain in my mouth, throat or neck.
The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|12 weeks (after treatment)|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||units on a scale||Standard Deviation|Mean
757419|NCT00608205|Secondary|Dry Mouth|"Quality of life questionnaire asking My mouth is dry.
The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|24 months from start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||units on a scale||Standard Deviation|Mean
757420|NCT00608205|Secondary|Dry Mouth|"Quality of life questionnaire asking My mouth is dry.
The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|12 months from start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||units on a scale||Standard Deviation|Mean
757421|NCT00608205|Secondary|Dry Mouth|"Quality of life questionnaire asking My mouth is dry.
The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|8 months from start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||units on a scale||Standard Deviation|Mean
757422|NCT00608205|Secondary|Dry Mouth|"Quality of life questionnaire asking My mouth is dry.
The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|12 weeks (after treatment)|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||units on a scale||Standard Deviation|Mean
757423|NCT00608205|Secondary|Nausea Level|"Quality of life questionnaire asking I have nausea."|24 months from start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||units on a scale||Standard Deviation|Mean
757424|NCT00608205|Secondary|Nausea Level|"Quality of life questionnaire asking I have nausea.
The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|12 months from start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||units on a scale||Standard Deviation|Mean
757425|NCT00608205|Secondary|Nausea Level|"Quality of life questionnaire asking I have nausea.
The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|8 months from start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||units on a scale||Standard Deviation|Mean
757426|NCT00608205|Secondary|Nausea Level|"Quality of life questionnaire asking I have nausea.
The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4).
N (number of patients analyzed) is based on number of patients who completed the question."|12 weeks (after treatment)|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||units on a scale||Standard Deviation|Mean
757427|NCT00608205|Secondary|Number of Patients That Required a Feeding Tube||24 months after start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||participants|||Number
757428|NCT00608205|Secondary|Number of Patients That Required a Feeding Tube||12 months after start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||participants|||Number
757429|NCT00608205|Secondary|Number of Patients That Required a Feeding Tube||8 months after start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||participants|||Number
757430|NCT00608205|Secondary|Number of Patients That Required a Feeding Tube||12 weeks (after treatment)|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||participants|||Number
757431|NCT00608205|Secondary|Disease Recurrence|Number of patients with any new evidence of cancer after achieving a complete response (at 12 weeks after completing chemoradiotherapy) are considered to have recurrent disease.|2 years after start of study|Patients that had a complete response after 12 weeks of therapy||participants|||Number
757456|NCT00608491|Secondary|Change in Plasma Renin Activity||Baseline to Day 60|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||ng/mL/hr||Standard Deviation|Mean
757457|NCT00608491|Secondary|Change in Blood N Terminal Pro - B Natriuretic Peptides||Baseline to Day 60|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||pg/mL||Standard Deviation|Mean
786177|NCT00833690|Secondary|Change in Serum Urate|Change from an Average of Baseline and Screening Visits|Visit 01 from Baseline (i.e., between -45 days and +2 weeks)|||mg/dL||Standard Deviation|Mean
757432|NCT00608205|Secondary|Number of Patients With a Pathological(Final)Complete Response|A Pathological, or final response will be assigned to subjects after any salvage surgery is performed for clinical persistent disease, and after planned neck dissection in those achieving a clinical complete response. If no surgery is performed after chemoradiotherapy, the clinical and pathological (final) response will be the same. Patient will be coded as having either a pathologic complete response, or as having pathologic persistent disease. A pathologic complete response will be defined as the total disappearance of all clinically and radiologically detectable tumor.|at 12 weeks after completing chemoradiotherapy and surgery|||participants|||Number
757433|NCT00608205|Secondary|Number of Patients With a Clinical Response-complete Disappearance of Detectable Tumor|Twelve weeks after completing chemoradiotherapy, a formal evaluation for response will be made, to include a careful evaluation by the head and neck surgeon, medical and radiation oncologists, and, as appropriate, a radiologic and an endoscopic examination. Patients will be considered to have achieved either a clinical complete response (i.e. complete disappearance of all clinically and radiologically detectable tumor) or to have clinical persistent disease.|at 12 weeks after completing chemoradiotherapy|intention to treat (ITT)||participants|||Number
757434|NCT00608205|Secondary|Overall Survival|Number of patients still alive from 2 years from start of study|2 yrs from start of study|intention to treat (ITT)||participants|||Number
757435|NCT00608205|Secondary|Patterns of Failure|Patients with any new evidence of cancer after achieving a complete response are considered to have recurrent disease. Biopsy verification will be obtained if at all possible and salvage surgery is recommended if possible. Disease recurrence will be characterized as either local, regional(nodal) or distant recurrence. Patients may have more than one kind of recurrence.|2 years from start of study|intention to treat (ITT)||participants|||Number
757436|NCT00608205|Primary|Relapse Free Survival|Number of patients that are alive without recurrence when recurrence is defined by any subject with new evidence of cancer after achieving a complete response. Complete response is defined by the complete disappearance of all clinically and radiologically detectable tumor..|at 2 yrs from start of study|intention to treat (ITT)||participants|||Number
757437|NCT00608244|Primary|Safety Evaluation|A combination of deaths, graft failure and biopsy proven acute rejections (BPAR) was used to evaluate the safety.|52 days|All enrolled patients are included in the safety population.||participants|||Number
757438|NCT00608244|Primary|Evaluation of Steady State Tacrolimus Exposure (AUC 0-24) on Day 21.|"Patients were converted from Prograf to LCP-Tacro on day 7. On day 21, AUC was measured (0 to 24 hours).
The following time points were used to obtain the PK curve for LCP-Tacro on day 21: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 20 and 24 hours post-dose."|21 Days|"57 completed the study but one patient was excluded from the PP analysis due to low trough levels.
The arithmetic mean and standard deviation is given."||ng*hr/mL||Standard Deviation|Mean
757439|NCT00608244|Primary|Evaluation of Steady State Tacrolimus Exposure Trough Levels (C24).|Patients were converted from Prograf to LCP-Tacro on day 7. On day 21, a trough level (C24) was measured.|21 Days|"57 completed the study but one patient was excluded from the PP analysis due to low trough levels.
The arithmetic mean and standard deviation is given."||ng/mL||Standard Deviation|Mean
757440|NCT00608244|Primary|Evaluation of Steady State Tacrolimus Exposure (AUC 0-24).|"Patients had a baseline AUC measured (0 to 24 hours) at day 7 before conversion to LCP-Tacro.
The following time points were used to obtain the PK curve for Prograf on day 7: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 12.5, 13, 13.5, 14, 15, 16, 20 and 24 hours after the morning dose."|7 Days|The arithmetic mean and standard deviation is given.||ng*hr/mL||Standard Deviation|Mean
757441|NCT00608244|Primary|Evaluation of Steady State Tacrolimus Trough Levels (C24).|Patients had a baseline trough level (C24) measured at day 7 before conversion to LCP-Tacro.|7 Days|The arithmetic mean and standard deviation is given.||ng/mL||Standard Deviation|Mean
757442|NCT00608322|Secondary|Lactate Clearance (Blood)||0-2 hours of study drug administration||||||
757443|NCT00608322|Primary|Change in Sublingual Microcirculatory Flow Index (MFI)|The MFI is a continuous scale from 0-3, with 3.0 being better outcome and 0.0 being worse outcome.|0-2 hours of study drug administration|||units on a scale||Inter-Quartile Range|Median
757444|NCT00608322|Primary|Change in the Sequential Organ Failure Assessment (SOFA) Score||0-24 hours from protocol initiation||||||
757445|NCT00608426|Secondary|7-day Point Prevalence Abstinence||12 months after randomizatoin|Out of the 3382 completed follow-up surveys, 3056 completed the 7-day point prevalence outcome.||percentage of participants|||Number
757446|NCT00608426|Secondary|Treatment Utilization Rates for Counseling and/or Pharmacotherapy||12 months after randomization|||percentage of participants|||Number
757447|NCT00608426|Primary|Self-reported, Smoking Abstinence Rate: 6-month Prolonged Abstinence||12 months after randomization|Out of the 3382 completed follow-up surveys, 3307 completed the primary smoking-abstinence outcome.||percentage of participants|||Number
757448|NCT00608465|Primary|This Study Will Analyze Patients' Genetic Make up to Identify Who May be at Greater Risk for Heart Disease and Strokes in Relationship to High Blood Pressure and Central Obesity.||10-weeks|Enrollment was never completed so study was never unblinded and data was never analyzed|||||
757449|NCT00608465|Primary|Secreted Factors From Adipocytes Have Autocrine, Paracrine and Endocrine Effects That Have a Deleterious Effect on the Fibrinolytic System, Either by Enhancing PAI-1 Production or Impairing Endothelial t-PA Release||10-Week period|Enrollment was never completed so study was never unblinded and data was never analyzed|||||
757450|NCT00608491|Secondary|Change in Blood Carboxy-terminal Telopeptide of Collagen Type I||Baseline to Day 60|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||ug/L||Standard Deviation|Mean
757451|NCT00608491|Secondary|Change in Blood High Sensitivity C-Reactive Protein||Baseline to Day 60|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mg/L||Standard Deviation|Mean
757452|NCT00608491|Secondary|Change in Blood Endothelin-1||Baseline to Day 60|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||pg/mL||Standard Deviation|Mean
757453|NCT00608491|Secondary|Change in Blood Procollagen III N-terminal Propepide||Baseline to Day 60|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||ug/L||Standard Deviation|Mean
757454|NCT00608491|Secondary|Change in Blood Aldosterone||Baseline to Day 60|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||pg/mL||Standard Deviation|Mean
757462|NCT00608491|Secondary|Change in Furosemide-Equivalent Dose|Furosemide-Equivalent Dose is the dose bumetanide or torsemide converted to furosemide equivalent (Torsemide dose x 2,Bumetanide dose x 40)|Baseline to Day 60|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mg||Standard Deviation|Mean
757463|NCT00608491|Secondary|Weight Change||Baseline to Day 60|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||lbs||Standard Deviation|Mean
757464|NCT00608491|Secondary|Glomerular Filtration Rate Change||Baseline to Day 30|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mL/min||Standard Deviation|Mean
757465|NCT00608491|Secondary|Creatinine Change||Baseline to Day 30|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mg/dL||Standard Deviation|Mean
757466|NCT00608491|Secondary|Change in Furosemide-Equivalent Dose|Furosemide-Equivalent Dose is the dose bumetanide or torsemide converted to furosemide equivalent (Torsemide dose x 2,Bumetanide dose x 40)|Baseline to Day 30|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mg||Standard Deviation|Mean
757467|NCT00608491|Secondary|Weight Change||Baseline to Day 30|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||lbs||Standard Deviation|Mean
757468|NCT00608491|Secondary|Change in Blood High Sensitivity C-Reactive Protein||Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mg/L||Standard Deviation|Mean
757469|NCT00608491|Secondary|Change in Blood Carboxy-terminal Telopeptide of Collagen Type I||Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||ug/L||Standard Deviation|Mean
757470|NCT00608491|Secondary|Change in Blood Endothelin-1||Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||pg/mL||Standard Deviation|Mean
757471|NCT00608491|Secondary|Change in Blood Procollagen III N-terminal Propepide||Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||ug/L||Standard Deviation|Mean
757472|NCT00608491|Secondary|Change in Blood Aldosterone||Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||pg/mL||Standard Deviation|Mean
757473|NCT00608491|Secondary|Change in Blood High Sensitivity Troponin I||Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||pg/mL||Standard Deviation|Mean
757474|NCT00608491|Secondary|Change in Plasma Renin Activity||Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||ng/mL/hr||Standard Deviation|Mean
757475|NCT00608491|Secondary|Change in Blood N Terminal Pro-Natriuretic Peptide||Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||pg/mL||Standard Deviation|Mean
757476|NCT00608491|Secondary|Change in Blood Uric Acid||Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mg/dL||Standard Deviation|Mean
757477|NCT00608491|Secondary|Change in Blood Cystatin C||Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mg/L||Standard Deviation|Mean
757478|NCT00608491|Secondary|Change in Blood Carboxy-terminal Telopeptide of Collagen Type I||Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||ug/L||Standard Deviation|Mean
757479|NCT00608491|Secondary|Change in Blood High Sensitivity C-Reactive Protein||Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mg/L||Standard Deviation|Mean
757480|NCT00608491|Secondary|Change in Blood Endothelin-1||Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||pg/mL||Standard Deviation|Mean
757481|NCT00608491|Secondary|Change in Blood Procollagen III N-terminal Propepide||Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||ug/L||Standard Deviation|Mean
757482|NCT00608491|Secondary|Change in Blood Aldosterone||Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||pg/mL||Standard Deviation|Mean
757483|NCT00608491|Secondary|Change in Blood High Sensitivity Troponin I||Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||pg/mL||Standard Deviation|Mean
757484|NCT00608491|Secondary|Change in Plasma Renin Activity||Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||ng/mL/hr||Standard Deviation|Mean
757485|NCT00608491|Secondary|Change in Blood N- Terminal Pro- BNP||Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||pg/mL||Standard Deviation|Mean
757486|NCT00608491|Secondary|Change in Uric Acid||Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mg/dL||Standard Deviation|Mean
757487|NCT00608491|Secondary|Change in Blood Cystatin C||Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mg/L||Standard Deviation|Mean
757488|NCT00608491|Secondary|Change in Blood Hemoglobin Level||Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||g/dL||Standard Deviation|Mean
757489|NCT00608491|Secondary|Change in Blood Bicarbonate Level||Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mEq/L||Standard Deviation|Mean
757490|NCT00608491|Secondary|Change in Blood Urea Nitrogen/Urea||Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mg/dL||Standard Deviation|Mean
757491|NCT00608491|Secondary|Change in Blood Potassium Level||Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mEq/L||Standard Deviation|Mean
786178|NCT00833690|Secondary|Serum Urate|From blood sample drawn a month after stopping study drug|Safety Visit (SV); 30 +/- 3 days following ESD or Month 24 Visit|||mg/dL||Standard Deviation|Mean
757498|NCT00608491|Secondary|Change in Furosemide-Equivalent Dose|Furosemide-Equivalent Dose is the dose bumetanide or torsemide converted to furosemide equivalent (Torsemide dose x 2,Bumetanide dose x 40)|Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mg||Standard Deviation|Mean
757499|NCT00608491|Secondary|Change in Global Visual Analog Scale|"Scale range: -100 , +100
-100=worse, +100=better Participants asked to mark their global well being on a 10 cm vertical line, with the top labeled “best you have ever felt” and the bottom labeled “worst you have ever felt”."|Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||units on a scale||Standard Deviation|Mean
757500|NCT00608491|Secondary|Change in Dyspnea Visual Analog Scale|"Scale range: -100 , +100
-100=worse, +100=better"|Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||units on a scale||Standard Deviation|Mean
757501|NCT00608491|Secondary|Change in Global Visual Analog Scale|"Scale range: -100 , +100
-100=worse, +100=better Participants asked to mark their global well being on a 10 cm vertical line, with the top labeled “best you have ever felt” and the bottom labeled “worst you have ever felt”."|Change from Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||units on a scale||Standard Deviation|Mean
757502|NCT00608491|Secondary|Dyspnea Visual Analog Scale|"Scale range: -100 , +100
-100=worse, +100=better"|Change from Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||units on a scale||Standard Deviation|Mean
757503|NCT00608491|Secondary|Cumulative Net Fluid Loss||Randomization through Day 7|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mL||Standard Deviation|Mean
757504|NCT00608491|Secondary|Cumulative Net Fluid Loss||Randomization through Day 6|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mL||Standard Deviation|Mean
757505|NCT00608491|Secondary|Cumulative Net Fluid Loss||Randomization through Day 5|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mL||Standard Deviation|Mean
757506|NCT00608491|Secondary|Cumulative Net Fluid Loss||Randomization through Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mL||Standard Deviation|Mean
757507|NCT00608491|Secondary|Cumulative Net Fluid Loss||Randomization through Day 3|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mL||Standard Deviation|Mean
757508|NCT00608491|Primary|Change in Weight||Change from Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||lbs||Standard Deviation|Mean
757509|NCT00608491|Secondary|Cumulative Net Fluid Loss||Randomization through Day 2|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mL||Standard Deviation|Mean
757510|NCT00608491|Secondary|Cumulative Net Fluid Loss||Randomization through Day 1|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mL||Standard Deviation|Mean
757511|NCT00608491|Secondary|Change in Weight||Change from Baseline to Day 6|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||lbs||Standard Deviation|Mean
757512|NCT00608491|Secondary|Changes in Weight||Change from Baseline to Day 5|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||lbs||Standard Deviation|Mean
757513|NCT00608491|Secondary|Change in Weight||Change from Baseline to Day 3|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||lbs||Standard Deviation|Mean
757514|NCT00608491|Secondary|Changes in Weight||Change from Baseline to Day 2|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||lbs||Standard Deviation|Mean
757515|NCT00608491|Secondary|Changes in Weight||Change from Baseline to Day 1|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||lbs||Standard Deviation|Mean
757516|NCT00608491|Secondary|Change in Glomerular Filtration Rate||Change from Baseline to Day 7|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mL/min||Standard Deviation|Mean
757517|NCT00608491|Secondary|Change in Serum Creatinine||Change from Baseline to Day 7|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mg/dL||Standard Deviation|Mean
757518|NCT00608491|Secondary|Change in Glomerular Filtration Rate||Change from Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mL/min||Standard Deviation|Mean
757519|NCT00608491|Primary|Change in Serum Creatinine||Change from Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mg/dL||Standard Deviation|Mean
757520|NCT00608517|Secondary|Number of Participants With Chronic Graft Versus Host Disease (GVHD)|As opposed to acute GVHD, which is characterized by rash, cholestasis, and enteritis, chronic GVHD is characterized by nausea, anorexia, ocular and oral sicca, and other organ involvement|100 days|||participants|||Number
757521|NCT00608517|Secondary|Overall Survival|Overall survival at 1 year|1 year|||participants|||Number
757522|NCT00608517|Secondary|Number of Subjects With All-cause Mortality|Death from any cause at 100 days|at 100 days|||participants|||Number
757523|NCT00608517|Secondary|Number of Participants Who Relapsed at 1 Year||1 year|||participants|||Number
757524|NCT00608517|Secondary|Number of Participants With Acute Graft-versus-host Disease (GVHD)|Participants who exhibit acute GVHD.|100 days|||participants|||Number
757525|NCT00608517|Secondary|Number of Participants With Sustained Donor Engraftment of Umbilical Cord Blood Stem Cells|Recovery of the neutrophil portion of white blood cells and showing complete donor cells.|42 days|Patients who received treatment and who did not die before day 42.||participants|||Number
757526|NCT00608517|Primary|Number of Participants With 100-day Non-relapse Mortality|Evaluate the safety (as determined by the day 100 non-relapse mortality) and feasibility of single or double umbilical cord blood (UCB)stem cell transplant (SCT) in adult or pediatric patients with hematologic malignancies receiving graft-versus-host disease (GVHD) prophylaxis with tacrolimus and mycophenolate mofetil (MMF).|100 days|||participants|||Number
757527|NCT00608530|Secondary|Percentage of Participants With at Least 25% Improvement on Global Impression of Change|"Participant rating of overall improvement compared to baseline in terms of back pain impact on everyday function, self-categorized as Improved, No change, or Worse. Participants rating themselves as Improved were asked to estimate percentage of improvement (i.e., 1 to 100%). Percentage of participants with at least 25% improvement were compared between treatment groups."|End of Treatment (8 weeks)|Based on per-protocol population, consisting of all participants who received at least one dose of the intervention and for whom baseline and week 8 data were available.||Percentage with at least 25% improvement|||Number
757528|NCT00608530|Secondary|Numeric Pain Rating Scale (Numerical Rating Scale, 0-10)|"The Numeric Pain Rating Scale asks the patient to rate their current intensity of pain on a scale from 0 to 1 0 where 0 indicates no pain and 10 indicates the worst imaginable pain."|Baseline, End of Treatment (8weeks)|Based on per protocol population. All participants with baseline and week 8 scores.||units on a scale||Standard Deviation|Mean
757529|NCT00608530|Primary|Roland and Morris Disability Questionnaire|"The Roland and Morris is a 24-item self-report measure of interference of back pain on everyday function at the present time. Each item is qualified by the phrase because of my back pain (e.g., Because of my back I walk more slowly than usual . . . ; Because of my back I lie down to rest more often). Scoring the measure involves summing the number of items endorsed (from 0 to 24). Lower scores indicate less disability."|Baseline, End of Treatment (8 weeks)|Per protocol population. All participants with baseline and Week 8 disability scores.||units on a scale||Standard Deviation|Mean
757530|NCT00608543|Primary|Spatial Working Memory (SWM) Strategy Score|The SWM task is part of the CANTAB neruopsychological test battery and is an executive function task assessing retention and manipulation of items in working memory, with the ability for assessment of perseverative (redundant) errors. The Strategy score represents the number of times a participant begins a search with the same box for 6- and 8-box problems. Minimum score is 8 and maximum score is 56. Higher numbers indicate poorer performance. Score reported is the difference between baseline and 6 weeks post-treatment.|baseline and 6 weeks|Completers; due to fact that testing occurred at pre- and post-intervention; mean represents difference between pre- and post-intervention||units on a scale||Standard Deviation|Mean
757531|NCT00608543|Primary|Spatial Working Memory (SWM) Between Errors for 6-move Problems|The SWM task is part of the CANTAB neruopsychological test battery and is an executive function task assessing retention and manipulation of items in working memory, with the ability for assessment of perseverative (redundant) errors. Between errors are times the subject revisits a box in which a token was previously found; errors are calculated for 4-, 6-, and 8-box trials. Higher numbers indicate poorer performance. Errors reported are the difference between baseline and 6 weeks post-treatment.|baseline and 6 weeks|Completers because data were collected pre- and post-treatment||number of errors||Standard Deviation|Mean
757532|NCT00608543|Primary|Stockings of Cambridge (SOC) Mean Initial Thinking Time for 5-move Problems|The SOC is part of the CAmbridge Neuropsychological Test Automated Battery (CANTAB) and is an executive function task based on the Tower of London test that assesses spatial planning for problems with 2, 3, 4, or 5 moves. The Mean Initial Thinking Time for 5-move problems is the time (in milliseconds) taken to plan a problem solution for trials requiring 5 moves. Higher numbers indicate poorer performance. Time reported is the difference between baseline and 6 weeks post-treatment.|baseline and 6 weeks|Completers; due to fact that testing occurred at pre- and post-intervention; mean represents difference between pre- and post-intervention||milliseconds||Standard Deviation|Mean
757533|NCT00608543|Secondary|Change in Hamilton Rating Scale for Depression (HRSD - 17-item)|The HRSD 17-item scale is a clinician-administered rating scale designed to assess the severity of symptoms in patients diagnosed with depression. Scores range from 0 to 52, with higher scores indicating higher levels of depression severity.|6 weeks|Study completers who completed the HRSD pre- and post-intervention; mean represents mean difference from pre- to post-intervention||units on a scale||Standard Deviation|Mean
757534|NCT00608543|Secondary|Quality of Life Enjoyment and Satisfaction Questionnaire|The Q-LES-Q general activities is designed to measure subjective satisfaction and enjoyment, as opposed to function, in various domains including physical health, feelings, work, household duties, school/course work, leisure time activities, social relations, and general activities. The raw score is converted into a percent of the maximum possible score and range from 0 to 100. Higher scores indicate greater enjoyment and satisfaction.|6 weeks|Study completers who completed the Q-LES-Q pre- and post-intervention; mean represents mean difference from pre- to post-intervention||units on a scale||Standard Deviation|Mean
757535|NCT00608543|Primary|Stockings of Cambridge (SOC) Mean Initial Thinking Time for 3-move Problems|The SOC is part of the CAmbridge Neuropsychological Test Automated Battery (CANTAB) and is an executive function task based on the Tower of London test that assesses spatial planning for problems with 2, 3, 4, or 5 moves. The Mean Initial Thinking Time for 3-move problems is the time (in milliseconds)taken to plan a problem solution for trials requiring 3 moves. Higher numbers indicate poorer performance. Time reported is the difference between baseline and 6 weeks post-treatment.|baseline and 6 weeks|Completers; due to fact that testing occurred at pre- and post-intervention; mean represents difference between pre- and post-intervention||milliseconds||Standard Deviation|Mean
757536|NCT00608569|Secondary|Adherence to Second Line HAART Regimen|Number of participants with self-reported 100% adherence over the week prior to study visit|At weeks 4, 8, 12, 24, 36, 48 and 52|Only the 257 eligible participants were included in the analysis. Self-reported adherence was collected face-to-face or by self-report on the Adherence/Quality of Life/Psychosocial Interview form. Only adherence to LPV/rtv was collected.||participants|||Number
757537|NCT00608569|Secondary|Time to First Grade 3 or 4 Lab or Sign/Symptom Event|5th and 10th percentiles in weeks from randomization to first grade 3 or 4 lab or sign/ symptom event|52 weeks since randomization|Two hundred fifty seven eligible participants were included in the analysis. As-treated analysis was performed.||weeks||95% Confidence Interval|Number
757538|NCT00608569|Secondary|Time to First Grade 3 or 4 Sign or Symptom|5th and 10th percentiles in weeks from randomization to first grade 3 or 4 sign or symptom|52 weeks since randomization|Two hundred fifty seven eligible participants were included in the analysis. As-treated analysis was performed.||weeks||95% Confidence Interval|Number
757539|NCT00608569|Secondary|Time to First Grade 3 or 4 Lab Event|5th and 10th percentiles in weeks from randomization to first grade 3 or 4 lab event|52 weeks since randomization|Two hundred fifty seven eligible participants were included in the analysis. As-treated analysis was performed.||weeks||95% Confidence Interval|Number
757542|NCT00608569|Secondary|Confirmed Virologic Failure at or Prior to Week 24|Confirmed virologic failure was defined as two successive HIV-1 RNA measurements at least 24 hours apart that were either:1) <1 log10 copies/mL below the baseline level and >400 copies/mL at the week 12 HIV-1 RNA evaluation (obtained at least 11 weeks after the date of the randomization) 2) >400 copies/mL at or after the week 24 HIV-1 RNA evaluation (obtained at least 23 weeks after the date of randomization). 3) subjects who discontinued the study follow-up for any reason other than study completion, including death, and who did so ≤30 weeks after randomization was considered to be a virologic failure. Number of participants experiencing or not experiencing virologic failure at or prior to week 24 was reported.|At or prior to Week 24|Two hundred fifty seven eligible participants were included in the analysis. Intent to treat analysis was performed.||participants|||Number
757543|NCT00608569|Primary|Confirmed Virologic Failure at or Prior to Week 48|Confirmed virologic failure was defined as two successive HIV-1 RNA measurements at least 24 hours apart that were either:1) <1 log10 copies/mL below the baseline level and >400 copies/mL at the week 12 HIV-1 RNA evaluation (obtained at least 11 weeks after the date of the randomization) 2) >400 copies/mL at or after the week 24 HIV-1 RNA evaluation (obtained at least 23 weeks after the date of randomization). 3) subjects who discontinued the study follow-up for any reason other than study completion, including death, and who did so ≤50 weeks after randomization was considered to be a virologic failure. Number of participants experiencing or not experiencing virologic failure at or prior to week 48 was reported.|At or prior to Week 48|Two hundred fifty seven eligible participants were included in the analysis. Intent to treat analysis was performed.||participants|||Number
757544|NCT00608582|Primary|Phrase Length|Longest Number of Words per Phrase Length, for elicited propositional speech for BDAE Cookie Theft Picture Description|Baseline and 2 months after the last rTMS treatment session|Chronic Stroke Patients with Aphasia who received either Real rTMS or Sham rTMS||number of words per phrase length||Standard Deviation|Mean
757545|NCT00608582|Primary|Picture Naming|Pictures named correctly on Boston Naming Test (BNT), First 20 Pictures|Baseline and 2 months after the last rTMS treatment session|Chronic Stroke Patients with Aphasia who receive either a Real rTMS series or a Sham rTMS series||number of pictures||Standard Deviation|Mean
757546|NCT00608634|Secondary|Skin Related Events From Perillyl Alcohol at Administered Doses by Participants|The events do not have to be caused by the drug or therapy, and they may be mild, moderate, or severe. (NCI)|3 months|||participants|||Number
757547|NCT00608634|Primary|Change in Histopathology Score of Sun Damaged Skin by Treatment Group|The histopathologic scoring for skin biopsies from sun-damaged skin to assess the following seven characteristics: 1- atypia (levels 0, 1 & 2), 2- inflammation (grades 0, 1 & 2), 3- hyperkeratosis (loss of basket weave pattern of stratum corneum), 4- parakeratosis (present when there were >3 characteristic nuclei per 40:1 field in stratum corneum), 5- dyskeratosis (focal presence of cells with homogenous, pink cytoplasm n pyknotic nuclei), 6- epidermotropism (lymphocytes migration of >3 cells into epidermis, 7- loss of granular layer. All assessments were done using a 40:1 objective.|Baseline to 3 months|change in histopathological scoring was calculated only for participants with baseline and end of study measurements. (n=79)||units on a scale||Standard Deviation|Mean
757548|NCT00608777|Primary|The Proportion of Subjects Who Acheive a Score of Clear (0) or Almost Clear (1) on the PGA of LMB at Week 2||week 2||||||
757549|NCT00608829|Primary|Freedom From Major Adverse Events and Major Device Events Through 1 Year Post-treatment|Major Adverse Event: a) requires therapy and short hospitalization (24 - 48 hours), b) requires major therapy, unplanned increase in level of care, prolonged hospitalization (>48 hours), c) permanent adverse sequelae, or d) death. (Sacks et. al.; JVIR, 1997; 8:137-149).|one year|||Participants|||Number
757550|NCT00608842|Primary|Number of Participants With Positive Histopathology Results at Week 20|After the completion of all tests and procedures scheduled for week 20, participants with treated lipomas that remained palpable could have their treated lipomas excised.|Week 20|Safety population with biopsy results at week 20||participants|||Number
757551|NCT00608842|Primary|Number of Participants With Positive Histopathology Results at Screening|A needle core tissue sample biopsy was performed at screening for all treated lipomas.|Screening (prior to randomization)|Safety population with biopsy results at screening||participants|||Number
757552|NCT00608842|Primary|Number of Participants With Clinically Significant Changes in Vital Signs or Weight||Up to 24 weeks|Safety population||participants|||Number
757553|NCT00608842|Secondary|Percent Change From Baseline in the Sum of the Areas of All Treated Lipomas|Percent change from baseline was calculated as the baseline total lipoma area - postbaseline total lipoma area / baseline total lipoma area * 100. A positive change indicates a reduction in size.|Baseline and week 12 (last treatment session), week 16 (4 weeks after last treatment), and week 20 (8 weeks after last treatment)|MITT Population||percent change||Standard Deviation|Mean
757554|NCT00608842|Primary|Number of Participants With Newly Occurring or Worsening Biochemistry/Hematology/Urinalysis Abnormalities|An abnormality is defined as a value outside the limits of the expanded normal range/notable range.|24 weeks|Safety population||participants|||Number
757555|NCT00608842|Secondary|Percentage of Participants With Complete Clearance or ≥ 75% Clearance|"At randomization 1 to 3 lipomas were selected for treatment. Lipomas were measured in 3 dimensions (longest length, perpendicular width, and height if possible) using digital calipers.
Complete clearance indicates target lipoma(s) not present or detectable, and ≥ 75% clearance is defined as a ≥ 75% reduction from baseline in the area of target lipoma(s).
For participants with > 1 target lipoma, the total area of all target lipomas was used in the calculation of response."|Baseline and week 20 (8 weeks after last dose)|MITT Population||percentage of participants|||Number
757572|NCT00608881|Secondary|Change in Total Motor Score From Baseline to Month 60|The motor section of the Unified Huntington's Disease Rating Scale (UHDRS) assesses motor features of Huntington disease with standardized ratings of oculomotor function, dysarthria, chorea, dystonia, gait, and postural stability. The total motor score is the sum of all the individual motor ratings, with higher scores (124) indicating more severe motor impairment than lower scores. The score ranges from 0 to 124.|Baseline and Month 60|||units on a scale||Standard Error|Least Squares Mean
757573|NCT00608881|Secondary|Change in Independence Scale Score From Baseline to Month 60|The independence scale assesses independence on a 0 to 100 scale with higher scores indicating better functioning.|Baseline and Month 60|||units on a scale||Standard Error|Mean
772063|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 6|Subject Satisfaction - hardness of erection when inflated|12 months post-surgery|||% satisfactory or somewhat satisfactory|||Number
757556|NCT00608842|Primary|Number of Participants With Adverse Events (AEs)|"Severity of AEs was determined using the following scale:
Mild: The participant was aware of a sign or symptom, but it was easily tolerated; Moderate: Discomfort or interference with usual activity; Severe: Incapacitating, with inability to engage in usual activity. The investigator determined the relationship of each AE to the administration of study material by answering the question: “Was there a reasonable possibility that the event may have been caused by treatment with study material?” A serious AE was an event that constituted a significant medical hazard or side effect, regardless of the investigator’s or sponsor’s opinion regarding relatedness to study material. Serious AEs included any event that was fatal or life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or other significant medical hazard."|Up to 24 weeks|Safety population (all participants who received at least 1 dose of study medication)||participants|||Number
757557|NCT00608868|Secondary|Adverse Event|An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.|Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009)|||participants|||Number
757558|NCT00608868|Secondary|Overall Survival||Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009) and every 12 weeks after progression until death or death.||||||
757559|NCT00608868|Secondary|Quality of Life and Symptom Improvement Based on Functional Assessment of Cancer Therapy-Lung (FACT-L)|"Patients recorded the presence and severity of 7 symptoms by using the lung cancer subscale(LCS) at FACT-L; shortness of breath, weight loss, clarity of thinking, cough, appetite, chest tightness, and difficulty breathing. Severity was assessed by using 0~4 scale (0=not at all to 4=very much). A possible score was 0~28.
The improvement rate defined as change of ≥6 points in overall FACT-L from baseline and the rate of patients who reported the change of points ≥2 in LCS of FACT-L.
The percentage of patients who showed improvement is reported."|Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009)|||percentage of participants|||Number
757560|NCT00608868|Secondary|Period of Progression-Free Survival|The median months without event of progression disease according to RECIST criteria is analysed.|Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009)|||months||95% Confidence Interval|Median
757561|NCT00608868|Primary|Objective Response Rate(ORR)|"Primary efficacy endpoint is a change in the proportion of subjects showing overall objective response rate(ORR) from baseline to final tumor assessment point after treatment. As per RECIST, the percentage of subjects indicating PR (partial response) or CR (complete response) will be calculated.
According RECIST criteria, CR(complete response) - the disappearance of all target lesions and ‘PR(partial response) - at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter."|Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009)|||Percent of participants|||Number
757562|NCT00608881|Secondary|Number Completing Study at Assigned Dosage Level||5 years|||participants completing study on drug|||Number
757563|NCT00608881|Secondary|Time to a Three-Point Decline in TFC Score or Death|TFC consists of five ordinally scaled items assessing a person’s capacity with: (1) occupation; (2) financial affairs; (3) domestic responsibilities; (4) activities of daily living; and (5) independent living. Total score ranges from zero (worst) to 13 (best).|5 years|||days to event||95% Confidence Interval|Median
757564|NCT00608881|Secondary|Time to a Two-Point Decline in TFC Score or Death|TFC consists of five ordinally scaled items assessing a person’s capacity with: (1) occupation; (2) financial affairs; (3) domestic responsibilities; (4) activities of daily living; and (5) independent living. Total score ranges from zero (worst) to 13 (best).|5 years|||days to event||95% Confidence Interval|Median
757565|NCT00608881|Secondary|Change in Stroop Interference Test - Interference From Baseline to Month 60|Stroop Interference Test - interference score is the total number of correct items identified in 45 seconds and reflects an executive measure of inhibitory ability.|Baseline and Month 60|||units on a scale||Standard Error|Least Squares Mean
757566|NCT00608881|Secondary|Change in Stroop Interference Test - Word Reading From Baseline to Month 60|Stroop Interference Test - word reading score is the total number of correct words read in 45 seconds and reflects processing speed.|Baseline and Month 60|||units on a scale||Standard Error|Least Squares Mean
757567|NCT00608881|Secondary|Change in Stroop Interference Test - Color Naming From Baseline to Month 60|Stroop Interference Test - color naming score is the total number of correct colors identified in 45 seconds and reflects processing speed.|Baseline and Month 60|||units on a scale||Standard Error|Least Squares Mean
757568|NCT00608881|Secondary|Change in Verbal Fluency Test From Baseline to Month 60|The verbal fluency test is typically considered a measure of executive function. The score is the number of correct words produced across three 1-minute trials.|Baseline and Month 60|||units on a scale||Standard Error|Least Squares Mean
757569|NCT00608881|Secondary|Change in Symbol Digit Modalities Test (SDMT) From Baseline to Month 60|The SDMT assesses attention, visuoperceptual processing, working memory, and cognitive/psychomotor speed. The score is the number of correctly paired abstract symbols and specific numbers in 90 seconds with higher scores indicating better cognitive functioning.|Baseline and Month 60|||units on a scale||Standard Error|Least Squares Mean
757570|NCT00608881|Secondary|Change in Behavioral Frequency x Severity Score From Baseline to Month 60|The Unified Huntington's Disease Rating Scale (UHDRS) behavioral subscale assesses frequency and severity of psychiatric-related symptoms, including depressed mood, apathy, low self-esteem/guilt, suicidal thoughts, anxiety, irritable behavior, aggressive behavior, obsessional thinking, compulsive behavior, delusions, and hallucinations. The total score is the sum of the product of the individual behavioral frequency and severity items (range 0-176) with higher scores representing more severe behavioral impairment.|Baseline and Month 60|||units on a scale||Standard Error|Least Squares Mean
757571|NCT00608881|Secondary|Change in Behavioral Frequency Score From Baseline to Month 60|The Unified Huntington's Disease Rating Scale (UHDRS) behavioral subscale assesses frequency and severity of psychiatric-related symptoms, including depressed mood, apathy, low self-esteem/guilt, suicidal thoughts, anxiety, irritable behavior, aggressive behavior, obsessional thinking, compulsive behavior, delusions, and hallucinations. A total score was calculated by summing up all the individual behavioral frequency items (range 0-56) with higher scores representing more severe behavioral impairment.|Baseline and Month 60|||units on a scale||Standard Error|Least Squares Mean
757574|NCT00608881|Secondary|Change in Functional Checklist Score From Baseline to Month 60|"The functional assessment checklist includes 25 questions about common daily tasks. A score of 1 is given for each yes reply and a score of 0 is given for each no reply (scale range is 0-25). Higher scores indicate better functioning."|Baseline and Month 60|||units on a scale||Standard Error|Mean
757575|NCT00608881|Secondary|Change in Total Functional Capacity (TFC) Score From Baseline to Month 60|TFC consists of five ordinally scaled items assessing a person’s capacity with: (1) occupation; (2) financial affairs; (3) domestic responsibilities; (4) activities of daily living; and (5) independent living. Total score ranges from zero (worst) to 13 (best).|Baseline and Month 60|||units on a scale||Standard Error|Least Squares Mean
757576|NCT00608881|Primary|Joint Rank (Combination of Time to Death (for Subjects Who Died) and Change in Total Functional Capacity Score (TFC) From Baseline to Month 60 (for Subjects Who Survived))|The primary outcome variable at the start of the trial was the change in TFC score from baseline to Month 60. The Data and Safety Monitoring Board recommended to the trial leadership that they reconsider how they accommodate missing data from subjects who die in their primary analysis of the change in TFC score. Based on these recommendations, the trial leadership changed the primary analysis to that of a joint rank approach. TFC consists of five ordinally scaled items assessing a person’s capacity with: (1) occupation; (2) financial affairs; (3) domestic responsibilities; (4) activities of daily living; and (5) independent living. Total score ranges from zero (worst) to 13 (best).|5 years|||rank||Standard Deviation|Mean
757577|NCT00608907|Primary|Area Under the Plasma Concentration-time Curve (AUC) 0-72 Hours||Cycle 3 day 14 (72 hours post last dose)|Pharmacokinetic (PK) evaluable population, include all subjects completed 3 cycles of treatment and all PK assessments during the first 3 cycles of the study.||ng*h/mL||Standard Deviation|Mean
757578|NCT00608959|Primary|Number of Subjects With Significantly Colonized Catheters, Defined as > or = to 15 Colony Forming Units- CFUs)|Roll plate cultures (quantitative) measured CFU on catheter tips after removal up to 7 days after insertion.|Each sampling point and the rate of catheter colonization for each treatment 72 hours to 7 days.|intravenous (IV) catheters were removed for culture from 5 subjects at 72 hours, 10 subjects at 5 days, and 10 subjects at 7 days.||participants|||Number
757579|NCT00608959|Primary|Change in Mean Number of Skin Bacterial Counts From Baseline to 7 Days|Change in the mean number of skin bacterial counts (log 10 CFU/cm2)which was calculated by subtracting log10 CFU/cm2 at 7 days (one sample per site per subject per timepoint) from log10CFU/cm2 at 0 hours in Part 2.Baseline was calculated by 'pooling' samples from 6 sites adjacent to each timepoint.|Prior to first application (0 hours) to 7 days post application.|In Part 2 of the study 25 subjects had only omiganan applied to sites across the upper chest or abdomen.Swab cultures were obtained over a period of 7 days at protocol-specified times||log 10 CFU/sq. cm||Standard Deviation|Mean
757580|NCT00608959|Primary|Change in Mean Number of Skin Bacterial Counts From Baseline to 72 Hours|Change in the mean number of skin bacterial counts (CFU/cm2) which was calculated by subtracting log10 CFU/cm2 at 72 hours (single sample per subject per timepoint) from the log10 CFU/cm2 at 0 hours (baseline) in Part 2.Baseline was calculated by 'pooling' samples from 6 sites adjacent to each timepoint.|Prior to first application (0 hours) to 72 hours post application|ITT set consists of all subjects who received at least one study treatment and had data available at 72 hours.||log 10 CFU/cm sq||Standard Deviation|Mean
757581|NCT00608985|Secondary|Change From Baseline to Week 1&2 in Subjective Latency to Sleep Onset (sLSO)|sLSO was the self-reported time to fall asleep as reported in the sleep diary|From baseline to Week 1&2|All treated patients with available data||minutes||95% Confidence Interval|Median
757582|NCT00608985|Secondary|Change From Baseline to Day 15&16 in LPS|LPS was defined as the time from the start of the PSG recording to the beginning of the first continuous 20 epochs (i.e., 10 minutes) scored as non-wake (i.e., either sleep stage 1 (S1), sleep stage 2 (S2), slow-wave sleep (SWS), or rapid eye movement sleep(REM)) as determined by PSG|From baseline to Day 15&16|All treated patients||minutes||95% Confidence Interval|Median
757583|NCT00608985|Secondary|Change From Baseline to Day 1&2 in Latency to Persistent Sleep (LPS)|LPS was defined as the time from the start of the PSG recording to the beginning of the first continuous 20 epochs (i.e., 10 minutes) scored as non-wake (i.e., either sleep stage 1 (S1), sleep stage 2 (S2), slow-wave sleep (SWS), or rapid eye movement sleep(REM)) as determined by PSG|From baseline to Day 1&2|All treated patients||minutes||95% Confidence Interval|Median
757584|NCT00608985|Primary|Change From Baseline to Week 1&2 in the Self-reported WASO (sWASO)|sWASO was the self-reported time spent awake after sleep onset as reported in the sleep diary. For sWASO assessed at home, the mean of all available data collected between Visits 3 and 4 (i.e., after the second morning of Visit 3 and before the first evening of Visit 4) was used for Week 1&2|From baseline to Week 1&2|All treated patients with available data||minutes||95% Confidence Interval|Median
757585|NCT00608985|Primary|Change From Baseline to Day 15&16 in WASO|"WASO was defined as the time spent in epochs scored as wake after onset of persistent sleep as determined by polysomnography (PSG) until lights on.
For WASO assessed at the study center, the mean of the 2 PSG nights at each of Visits 3 and 4 was used for Day 1&2 and Day 15&16"|From baseline to Day 15&16|All treated patients||minutes||95% Confidence Interval|Median
757586|NCT00608985|Primary|Change From Baseline to Day 1&2 in Wake After Sleep Onset (WASO)|"WASO was defined as the time spent in epochs scored as wake after onset of persistent sleep as determined by polysomnography (PSG) until lights on.
For WASO assessed at the study center, the mean of the 2 PSG nights at each of Visits 3 and 4 was used for Day 1&2 and Day 15&16"|From baseline to Day 1&2|All treated patients||minutes||95% Confidence Interval|Median
757587|NCT00609167|Secondary|Participants Who Successfully Completed Collection of Peripheral Blood Stem Cells for Transplant|Evaluation of the ability to successfully collect peripheral blood stem cells following four months (cycles) of combination therapy.|After 4 cycles of treatment|At the time of publication, data was available on 18 patients for group 2.||participants|||Number
757588|NCT00609167|Secondary|Number of Participants With Severe Adverse Events|Severe adverse events were defined as grade 3 or higher, regardless of attribution to study drugs. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.|Every cycle during treatment (up to 12 cycles)|||participants|||Number
757658|NCT00609674|Secondary|Peak Nasal Inspiratory Flow (PNIF): Mean Change From Baseline in Daily, AM, and PM PNIF|PNIF: Objective measure of nasal airway flow obstruction.|Daily; Baseline through End of Study (Week 4)|ITT Population||Liters/minute||Standard Error|Least Squares Mean
757589|NCT00609167|Secondary|Number of Participants Who Responded to Treatment (CR, nCR, VGPR or PR) After 12 Cycles|"Response that was confirmed on 2 consecutive evaluations after 12 cycles of treatment.
Criteria for CR, nCR, VGPR and PR are defined in prior outcomes."|After 12 cycles of treatment|No participants received 12 cycles of treatment; therefore, all participants are non-evalualble.||participants|||Number
757590|NCT00609167|Secondary|Number of Participants Who Responded to Treatment (CR, nCR, VGPR or PR) After 8 Cycles|"Response that was confirmed on 2 consecutive evaluations after 8 cycles of treatment.
Criteria for CR, nCR, VGPR and PR are defined in prior outcomes."|After 8 cycles of treatment|Participants who received 8 cycles of treatment were analyzed.||participants|||Number
757591|NCT00609167|Secondary|Duration of Response|Duration of response was calculated from the documentation (date) of first response (CR, nCR, VGPR, or PR) until the date of progression or last follow-up in the subset of patients who responded.|Duration of study (up to 12 cycles)|Participants who achieved a partial response(PR) or better were evaluable for this analysis.||months||95% Confidence Interval|Median
757592|NCT00609167|Secondary|Number of Participants Who Responded to Treatment (Complete Response,CR; Near Complete Response, nCR; Very Good Partial Response, VGPR; or Partial Response, PR) After 4 Cycles|"Response that was confirmed on 2 consecutive evaluations after 8 months of treatment.
CR, nCR and VGPR as defined in the primary outcome.
Partial Response(PR): >=50% reduction in serum M-component and/or
Urine M-Component >=90% reduction or <200mg per 24hours; or >=50% decrease in difference between involved and uninvolved FLC levels."|4 cycles|Participants who received 4 cycles of treatment were analyzed.||participants|||Number
757593|NCT00609167|Secondary|Overall Survival (OS)|OS was defined as the time from registration to death of any cause.|From date of registration until death (up to 5 years)|||months||95% Confidence Interval|Median
757594|NCT00609167|Secondary|Progression Free Survival (PFS)|"PFS was defined as the time from registration to progression or death due to any cause.
Progression was defined as any one or more of the following:
An increase of 25% from lowest confirmed response in:
Serum M-component (absolute increase >= 0.5g/dl)
Urine M-component (absolute increase >= 200mg/24hour
Difference between involved and uninvolved Free Light Chain levels (absolute increase >= 10mg/dl)
Bone marrow plasma cell percentage (absolute increase of >=10%)
Definite development of new bone lesion or soft tissue plasmacytomas"|up to 5 years|||months||95% Confidence Interval|Median
757595|NCT00609167|Primary|Number of Participants Who Achieved a Confirmed Responses Defined as a Complete Response (CR), Near CR or Very Good Partial Response (VGPR) After the First 4 Months of Treatment|"Response that was confirmed on 2 consecutive evaluations during the first 4 months of treatment.
Complete Response(CR): Complete disappearance of M-protein from serum and urine on immunofixation, normalization of Free Light Chain (FLC) ratio and <5% plasma cells in bone marrow.
near Complete Response (nCR): Patients who meet all criteria for CR except a positive immunofixation will be classified as nCR.
Very Good Partial Response(VGPR): >=90% reduction in serum M-component; Urine M-Component <100mg per 24hours; <=5% plasma cells in bone marrow."|After 4 months of treatment|||participants|||Number
757596|NCT00609245|Primary|Difference in SPR During Placebo and VPA Infusions|"standard photosensitive range (SPR) Each participant is exposed to intermittent photic stimulation at 14 predetermined frequencies in order to detect changes in response around typical upper and lower frequency thresholds (e.g., 2 Hz, 5 Hz, 8Hz, 10 Hz, etc.). Each flash frequency that elicits a photosensitive response is considered one step, and the result is transformed into a metric called the standardized photosensitive range (SPR). The SPR ranges from 0 to 14, where each point represents the number of flash frequencies that elicited a photosensitive response."|At the start of EEG monitoring/drug infusion, and on an hourly basisfor 12 hours|1 patient did not complete infusion of Valproic Acid due to Adverse Event. This patient was not included in final analysis.||standard photosensitive range (SPR)||Full Range|Mean
757597|NCT00609336|Secondary|Percent of Patients Surviving at Annual Intervals||5 years|||percentage of participants|||Number
757598|NCT00609336|Secondary|Frequency and Severity of Toxicities Associated With This Treatment Regimen as Assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0||Up to 26 weeks after surgery (the end of adjuvant chemotherapy)|All eligible patients||occurrence of toxicities|||Number
757599|NCT00609336|Secondary|Surgical Completion Rate and Complication Rate||Up to 6 weeks following the completion of chemoradiotherapy|all eligible patients||Participants|||Count of Participants
757600|NCT00609336|Secondary|CA 19-9 Tumor Marker Response Rate to Neoadjuvant Chemotherapy and Chemoradiotherapy|Biochemical response is a decrease of >= 50% of CA 19-9 serum tumor marker in patients with elevated CA 19-9 at baseline.|Up to 26 weeks after surgery|Biomarker data not collected.|||||
757601|NCT00609336|Secondary|Pathologic Response Rate (Complete, Near-complete, Partial) to Neoadjuvant Chemotherapy and Chemoradiotherapy|The resected pancreaticoduodenectomy specimen and accompanying lymph nodes will be staged according to American Joint Committee on Cancer 6th Edition incorporating the prefix y to indicate a specimen status-post neoadjuvant treatment (ypTNM). Cancer 2012;118:1382-90|Up to 7 years|all eligible patients with non-missing data||Participants|||Count of Participants
757602|NCT00609336|Secondary|Clinical Response Rate to Neoadjuvant Chemotherapy and Chemoradiotherapy|Assessed using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee.|Up to 7 years|Clinical response not collected.|||||
757603|NCT00609336|Secondary|Median Recurrence Free Survival Following Pancreaticoduodenectomy|The appearance of radiographic findings consistent with recurrent tumor at the local resection site or at a distant location is considered a radiographic recurrence.|From the date of pancreaticoduodenectomy to date of first observation of radiographic recurrence or death due to any cause, assessed up to 7 years|Among eligible patients who received surgery||months||95% Confidence Interval|Median
757604|NCT00609336|Secondary|Percent of Patients Surviving at 5 Years|Kaplan-Meier estimate of overall survival at 5 years|Up to 5 years|all eligible patients||percentage of eligible pts alive|||Number
757605|NCT00609336|Primary|Median Overall Survival of Patients With Adenocarcinoma of the Pancreas|Time at which Kaplan-Meier estimate of overall survival drops below 50%|5 years|All eligible patients||months||95% Confidence Interval|Median
757606|NCT00609362|Secondary|Change in Gene Expression in Bone Marrow and Fat Cells||Before and after treatment||||||
757706|NCT00603746|Secondary|Number Participants Who Withdrew Due to Lack of Efficacy During the 8-week Treatment Period|The number of participants whose primary reason for withdrawal was lack of efficacy was analyzed.|From the first dose of the study medication up to Week 8/Early Withdrawal|ITT Population||participants|||Number
757607|NCT00609362|Secondary|Difference in Percent Change in Level of C-terminal Telopeptide (CTx) Between the Rosiglitazone and Placebo Groups|C-terminal telopeptide is a marker of bone resorption. Its levels are measure in plasma using a chemiluminometric method (ECLIA).|At baseline and after 14 weeks of treatment|||Percent change from baseline||Standard Deviation|Mean
757608|NCT00609362|Secondary|Difference in Percent Change in Bone Marrow Fat (Given by a Lipid to Water Ratio) in the Spine.|Bone marrow fat was measured using MRI spectroscopy providing a measure of bone marrow fat as a ratio to bone marrow water, the lipid-water ratio (LWR)|Measured at baseline and after 14 weeks of treatment|||Percent change in LWR||Standard Deviation|Mean
757609|NCT00609362|Primary|Difference in Percent Change in Bone Mineral Density (BMD) From Baseline to 14 Weeks Between the Rosiglitazone Group and the Placebo Group|Difference in percent change in bone mineral density (BMD) from baseline to 14 weeks between the rosiglitazone group and the placebo group. BMD was assesed using dual x-ray absorptiometry (DXA)|BMD measured at baseline and after 14 weeks of treatment|||Percent change from baseline||Standard Deviation|Mean
757610|NCT00609466|Secondary|Sum of Pain Intensity Differences Over 72 Hours (SPID72) Relative to the Baseline Pain Intensity|"Pain Intensity assessed at predefined time points over a 72 hour period using an 11-point Numeric Rating Scale (NRS) where a score of zero indicates no pain and a score of ten indicates pain as bad as you can imagine. Differences calculated as [baseline-post baseline] at each predefined time point. The theoretical maximum range of Sum of pain intensity differences (SPID72) is from -720 (indicative of an increase in pain) to 720 (indicative of a decrease in pain)."|Baseline to 72 hours after first intake of study drug|Intention to treat (ITT) and Last Observation Carried Forward (LOCF).||units||Standard Deviation|Mean
757611|NCT00609466|Secondary|Sum of Pain Intensity Differences Over 24 Hours (SPID24) Relative to the Baseline Pain Intensity|"Pain Intensity assessed at predefined time points over a 24 hour period using an 11-point Numeric Rating Scale (NRS) where a score of zero indicates no pain and a score of ten indicates pain as bad as you can imagine. Differences calculated as [baseline-post baseline] at each predefined time point. The theoretical maximum range of Sum of pain intensity differences (SPID24) is from -240 (indicative of an increase in pain) to 240 (indicative of a decrease in pain)."|Baseline to 24 hours after first study drug intake|Intention to treat (ITT)and Last Observation Carried Forward (LOCF).||units||Standard Deviation|Mean
757612|NCT00609466|Secondary|Sum of Pain Intensity Differences Over 12 Hours (SPID12) Relative to the Baseline Pain Intensity|"Pain Intensity assessed at predefined time points over a 12 hour period using an 11-point Numeric Rating Scale (NRS) where a score of zero indicates no pain and a score of ten indicates pain as bad as you can imagine. Differences calculated as [baseline-post baseline] at each predefined time point. The theoretical maximum range of Sum of pain intensity differences (SPID12) is from -120 (indicative of an increase in pain) to 120 (indicative of a decrease in pain)."|Baseline to 12 hours after first study drug intake|Intention to treat (ITT) and Last Observation Carried Forward (LOCF).||units||Standard Deviation|Mean
757613|NCT00609466|Secondary|Sum of Pain Intensity Differences Over 6 Hours (SPID6) Relative to the Baseline Pain Intensity|"Pain Intensity assessed at predefined time points over a 6 hour period using an 11-point Numeric Rating Scale (NRS) where a score of zero indicates no pain and a score of ten indicates pain as bad as you can imagine. Differences calculated as [baseline-post baseline] at each predefined time point. The theoretical maximum range of Sum of pain intensity differences (SPID6) is from -60 (indicative of an increase in pain) to 60 (indicative of a decrease in pain)."|Baseline to 6 hours after intake of first study drug|Intention to treat(ITT) and Last Observation Carried Forward (LOCF).||units||Standard Deviation|Mean
757614|NCT00609466|Secondary|Total Pain Relief (TOTPAR)|Total pain relief (TOTPAR) in the 48 hour period from the first dose of study drug. The subject was to indicate pain relief at rest in response to the following question: How much relief have you had from your starting pain? None = 0, A little = 1, Some = 2, A lot = 3 and Complete = 4. The theoretical maximum range of Total pain relief (TOTPAR)48 is from 0 (indicative of no pain relief) to 192. The higher the value the better the pain relief.|Baseline to 48 hours after first study drug intake|Intention to treat(ITT)and Last Observation Carried Forward (LOCF)||units||Standard Deviation|Mean
757615|NCT00609466|Secondary|Number of Participants Using Rescue Medication|Number of participants who used at least one dose of rescue medication during the 72 hour double blind period.|Baseline up to 72 hours after first study drug intake|Intention to treat (ITT) and Last Observation Carried Forward (LOCF)||participants|||Number
757616|NCT00609466|Primary|Sum of Pain Intensity Differences Relative to the Baseline Pain Intensity.|"Pain Intensity assessed at predefined time points over a 48 hour period using an 11-point Numeric Rating Scale (NRS) where a score of zero indicates no pain and a score of ten indicates pain as bad as you can imagine. Differences calculated as [baseline-post baseline] at each predefined time point. The theoretical maximum range of Sum of pain intensity differences (SPID48) is from -480 (indicative of an increase in pain) to 480 (indicative of a decrease in pain)."|Baseline value to 48 hours after first study drug intake.|Intention to Treat - randomized subjects who were dosed and had a baseline pain intensity assessment. Last observation carried forward was used.||units||Standard Deviation|Mean
757617|NCT00609492|Secondary|Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A|Seropositivity status was defined as the opsonophagocytic activity (OPA) against pneumococcal cross-reactive serotypes 6A and 19A, with a cut-off value greater than or equal to (≥) 8, presented as geometric mean titers (GMTs).|One month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Titers||95% Confidence Interval|Geometric Mean
757618|NCT00609492|Secondary|Number of Seropositive Subjects for Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A|A seropositive subject was defined as a subject with opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A greater than or equal to (≥) the cut-off value of 8.|One month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
757619|NCT00609492|Secondary|Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes|Seropositivity status was defined as the opsonophagocytic activity (OPA) against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, with a cut-off value greater than or equal to (≥) 8, presented as geometric mean titers (GMTs).|One month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Titers||95% Confidence Interval|Geometric Mean
757620|NCT00609492|Secondary|Number of Seropositive Subjects for Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes|A seropositive subject was defines as a subject with opsonophagocytic activity cut-off value greater than or equal to (≥) the value of 8. The vaccine pneumococcal serotypes investigated were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.|One month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
757621|NCT00609492|Secondary|Antibody Concentrations Against Anti-hepatitis B Surface Antigen (HBs)|Seroprotection status was defined as the Anti-HBs antibody concentrations greater than or equal to (≥) 10 milli international units per milliliter (mIU/mL), presented as geometric mean concentrations (GMCs).|Prior to (Pre-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine|The analysis was performed on the ATP cohort for persistence, which included all subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sampling taken before the administration of the study booster dose.||mIU/mL||95% Confidence Interval|Geometric Mean
757622|NCT00609492|Secondary|Antibody Titers Against Anti-polio Type 1, 2 and 3|Seroprotection status was defined as the anti-polio type 1, anti-polio type 2 and anti-polio type 3 antibody titers greater than or equal to (≥) the cut-off value of 8, presented as geometric mean titers (GMTs).|Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Titers||95% Confidence Interval|Geometric Mean
757623|NCT00609492|Secondary|Number of Seroprotected Subjects Against Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3)|A seroprotected subject was defined as a subject who had anti-polio types 1, 2 and 3 titers greater than or equal to (≥) the value of 8.|Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
757624|NCT00609492|Secondary|Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies|Vaccine response was defined as antibody concentrations ≥ 5 EL.U/mL at post-booster, for initially seronegative subjects (S-) (with concentrations < 5 EL.U/mL) and for initially seropositive subjects (S+) (with concentrations ≥ 5 EL.U/mL), antibody concentrations at post-booster ≥ 2 fold the pre-vaccination antibody concentration.|One month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
757625|NCT00609492|Secondary|Antibody Concentrations Against Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)|Seropositivity status was defined as the anti-pertussis toxoid (Anti-PT), anti-filamentous haemagglutinin (Anti-FHA) and anti-pertactin (Anti-PRN) antibody concentrations greater than or equal to (≥) 5 ELISA units per milliliter (EL.U /mL). Antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs).|Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||EL.U/mL||95% Confidence Interval|Geometric Mean
757626|NCT00609492|Secondary|Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti- Filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)|A seropositive subject was defined as a subject who had anti-PT, anti-FHA and anti-PRN concentrations greater than or equal to (≥) the value of 5 ELISA units per milliliter (EL.U/mL).|Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
757627|NCT00609492|Secondary|Antibody Concentrations Against Anti-polyribosyl-ribitol-phosphate (Anti-PRP)|Seropositivity status was defined as the anti-polyribosyl-ribitol-phosphate (Anti-PRP) antibody concentrations greater than or equal to (≥) 0.15 micrograms per milliliter (µg /mL) and ≥ 1.0 µg/mL. Antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs).|Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™ -IPV/Hib vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||µg/mL||95% Confidence Interval|Geometric Mean
757876|NCT00611767|Secondary|Visual Analog Scales (VAS) - Anxious - 80 Minutes|visual analog scale (VAS): self-report scale used to measure anxiety (0 not at all anxious - 7 extremely anxious)|80 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
757628|NCT00609492|Secondary|Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration ≥ 1.0 µg/mL|The concentration of anti-polyribosyl-ribitol phosphate (Anti-PRP) antibody assessed was greater than or equal to (≥) the value of 1.0 micrograms per milliliter (µg /mL).|Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
757629|NCT00609492|Secondary|Number of Seroprotected Subjects Against Anti-polyribosyl-ribitol Phosphate (Anti-PRP)|A seroprotected subject was defined as a subject who had anti-PRP concentrations greater than or equal to (≥) the value of 0.15 micrograms per milliliter (µg /mL).|Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
757630|NCT00609492|Secondary|Antibody Concentrations Against Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT)|Seropositivity status was defined as the anti-diphtheria toxoid (Anti-DT) and anti-tetanus toxoid (Anti-TT) antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL). Antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs).|Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||IU/mL||95% Confidence Interval|Geometric Mean
757631|NCT00609492|Secondary|Number of Seroprotected Subjects Against Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT)|A seroprotected subject was defined as a subject who had anti-DT and anti-TT concentrations greater than or equal to (≥) the value of 0.1 international units per milliliter (IU/mL).|Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
757632|NCT00609492|Secondary|Antibody Concentrations Against Protein D (Anti-PD)|Seropositivity status was defined as the anti-protein D (Anti-PD) antibody concentrations greater than or equal to (≥) 100 ELISA units per milliliter (EL.U/mL). Antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs).|Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||EL.U/mL||95% Confidence Interval|Geometric Mean
757633|NCT00609492|Secondary|Number of Seropositive Subjects for Protein D Antibodies (Anti-PD)|A seropositive subject was defined as a subject who had anti-PD concentration greater than or equal to (≥) the value of 100 ELISA units per milliliter (EL.U/mL).|Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
757634|NCT00609492|Secondary|Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A|Seropositivity status was defined as the anti-pneumococcal cross-reactive serotypes 6A and 19A antibody concentrations greater than or equal to (≥) the cut-off value of 0.05 micrograms per milliliter (µg/mL). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs).|Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||µg/mL||95% Confidence Interval|Geometric Mean
757635|NCT00609492|Secondary|Number of Seropositive Subjects for Pneumococcal Cross-reactive Serotypes 6A and 19A|A seropositive subject was defined as a subject who had the anti-pneumococcal serotypes 6A and 19A concentrations greater than or equal to (≥) the cut-off value of 0.05 micrograms per milliliter (μg/mL).|Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™ -IPV/Hib vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
757636|NCT00609492|Secondary|Antibody Concentrations Against Pneumococcal Serotypes|Seropositivity status was defined as the anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations greater than or equal to (≥) the cut-off value of 0.05 micrograms per milliliter (µg/mL). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs).|Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||µg/mL||95% Confidence Interval|Geometric Mean
757730|NCT00609986|Primary|Delayed Graft Function|Need for dialysis in the first week post-transplant in a patient who required dialysis pre-transplantation or day-10 post-transplant creatinine concentration above 2.5 mg/dl.|10 days|The intent-to-treat analysis set consisted of the participants that underwent a renal transplant.||participants|||Number
757637|NCT00609492|Secondary|Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes|A seroprotected subjects was defined as a subject who had anti-pneumococcal serotypes antibody concentrations greater than or equal to (≥) the threshold value of 0.20 micrograms per milliliter (μg/mL). The anti-pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.|Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
757638|NCT00609492|Secondary|Number of Seropositive Subjects for Anti-pneumococcal Serotypes|A seropositive subject was defined as a subject who had the anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C , 19F and 23F concentrations greater than or equal to (≥) the cut-off value of 0.05 micrograms per milliliter (μg/mL).|Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™ -IPV/Hib vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
757639|NCT00609492|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Throughout the entire study period starting from Month 0 up to the end of the extended safety follow-up (Month 6)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Subjects|||Number
757640|NCT00609492|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Throughout the active phase of the study (Month 0 to Month 1)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Subjects|||Number
757641|NCT00609492|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. “Any” is defined as incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.|Within 31-days (Day 0-30) after booster vaccination|The analysis was performed on the Total vaccinated cohort, which included all vaccinated subjects for whom data were available.||Subjects|||Number
757642|NCT00609492|Secondary|Number of Subjects With Any and Grade 3 Solicited General Symptoms|Solicited general symptoms assessed included drowsiness, fever (defined as rectal temperature ≥ 38.0°C), irritability, and loss of appetite. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectal temperature) above (>) 40.0 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all. “Any” is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination.|Within 4-days (Day 0-3) after booster vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had filled in the symptom sheet.||Subjects|||Number
757643|NCT00609492|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed included pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (>) 30 millimeters (mm). “Any” is defined as incidence of the specified symptom regardless of intensity.|Within 4-days (Day 0-3) after booster vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had filled in the symptom sheet.||Subjects|||Number
757644|NCT00609492|Primary|Number of Subjects Reporting Fever With Rectal Temperature Above (>) 39.0 Degrees Celsius (°C)|Fever was measured as rectal temperature. Assessment of occurrences of fever > 39.0 °C was performed within 4-days (Day 0-3) after booster vaccination of Synflorix™ and Infanrix™-IPV/Hib vaccine.|Within 4-days (Day 0-3) after booster vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had filled in the symptom sheet.||Subjects|||Number
757645|NCT00609518|Secondary|Progression-free Survival (PFS)|Defined as the time from date of first dose to the first observation of disease progression, or death due to any cause. For patients who are alive and have not progressed, PFS is censored at the date of last radiological assessment.|Randomization (≤4 weeks from baseline visit) to 12 months after randomization|Qualified Intent to Treat (Q-ITT)||months||95% Confidence Interval|Median
757646|NCT00609518|Secondary|Overall Survival|Overall survival is the duration from randomization to death. For patients who are alive, overall survival is censored at the date of last contact.|Randomization (≤4 weeks from baseline visit) to 12 months after randomization|Qualified Intent to Treat (Q-ITT)||months||95% Confidence Interval|Median
757647|NCT00609518|Secondary|Proportion of Participants With Best Overall Tumor Response (Response Rate)|Response defined per Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. Best Overall Tumor Response is complete response plus partial response.|Baseline until disease progression, new therapy initiated, or death from any cause, up to 12 months after enrollment.|Qualified Intent to Treat (Q-ITT)||proportion of patients||95% Confidence Interval|Mean
757648|NCT00609518|Primary|Safety: Number of Participants With Drug-Related Grade 3 or 4 Toxicity|"Results are presented for the number of participants with drug-related Grade 3 or 4 toxicity/adverse event (AE). Grades range from 0 (none) to 5 (death), with Grade 3 and 4 being defined as follows:
Grade 0 = No AE; Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE; Grade 5 = Death related to AE. A detailed list of Serious and non-serious adverse events is provided in the Reported Adverse Event section."|From first dose of treatment to last dose of treatment plus 30 days|Qualified Intention to Treat (Q-ITT)||participants|||Number
757649|NCT00609622|Secondary|Change From Baseline in Functional Assessment of Cancer Treatment – Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score|FACT&GOG-Ntx has a 13-item, treatment-specific subscale for patients with neurotoxicity. It is the sum of the PWB (7 items), FWB (7 items), SWB (7 items) and EWB (6 items) subscales plus a 13 item neurotoxicity subscale. Subscale score ranges from 0 to 28 for PWB, FWB, SWB, 0 to 24 for EWB and 0 to 52 for neurotoxicity subscale. Total possible score range is 0 to 160. Higher scores indicates better QoL, fewer disease symptoms, and/or fewer side effects of treatment and lower scores indicate worse QoL and a greater impact of disease symptoms and/or side effects.|Baseline (D1 of C1) then every 3 cycles thereafter and at the EOT or withdrawal visit (up to 115 weeks)|The FA set included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug according to the randomization schedule, or received a different drug from that to which they were randomized.||Units on a scale||Standard Deviation|Mean
757650|NCT00609622|Secondary|Change From Baseline in Functional Assessment of Cancer Treatment – Colorectal (FACT-C) Score|FACT-C used for assessment of health-related quality of life (QoL) in participants with cancer. It consists of 36 items, summarized to 5 subscales:physical well-being (PWB) (7 items), functional well-being (FWB) (7 items), social/family well-being (SWB) (7 items); all 3 subscales range from 0 to 28, emotional well-being (EWB) (6 items) range from 0 to 24, colorectal cancer subscale (9 items) range from 0 to 36; higher subscale score=better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score range: 0 to 144. High scale score represents a better QoL.|Baseline [Day (D) 1 of Cycle (C) 1] then every 3 cycles thereafter and at the end of treatment (EOT) or withdrawal visit (up to Week 115)|FA set included participants randomized with study drug assignment, regardless of whether participants received study drug, or received a different drug from that to which they were randomized. Here “n” signifies those participants evaluated for this measure at specific time point for each cohort respectively.||Units on a scale||Standard Deviation|Mean
757651|NCT00609622|Secondary|Duration of Response (DR)|Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Baseline until disease progression or discontinuation of the study, at every 8-week intervals for 18 months, and then every 12 weeks thereafter up to Week 115|Data was not analyzed due to early study termination.|||||
757652|NCT00609622|Secondary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.|Baseline until disease progression or discontinuation of the study, at every 8-week intervals for 18 months, and then every 12 weeks thereafter up to Week 115|The FA set included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug according to the randomization schedule, or received a different drug from that to which they were randomized.||Percentage of participants||95% Confidence Interval|Number
757653|NCT00609622|Secondary|Two Year Survival Probability|Two year survival probability was defined as the probability of survival at two years after the first dose of study treatment.|Baseline, at every 8-week intervals for 18 months, and then every 12 weeks thereafter up to every 2 months until death (up to 2 years)|Data was not analyzed due to early study termination.|||||
757654|NCT00609622|Secondary|One Year Survival Probability|One year survival probability was defined as the probability of survival at one year after the first dose of study treatment.|Baseline, at every 8-week intervals for 18 months, and then every 12 weeks thereafter up to every 2 months until death (up to 1 year)|Data was not analyzed due to early study termination.|||||
757655|NCT00609622|Secondary|Overall Survival (OS)|Time in weeks from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Baseline, at every 8-week intervals for 18 months, and then every 12 weeks thereafter up to every 2 months until death (up to Week 115)|The FA set included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug according to the randomization schedule, or received a different drug from that to which they were randomized.||Weeks||95% Confidence Interval|Median
757656|NCT00609622|Primary|Progression-free Survival (PFS)|"Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Baseline, at every 8-week intervals for 18 months then every 12 weeks thereafter until disease progression (up to Week 115)|The Full Analysis (FA) set included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug according to the randomization schedule, or received a different drug from that to which they were randomized.||Weeks||95% Confidence Interval|Median
757657|NCT00609674|Secondary|Mean Change From Baseline to Endpoint in the Rhinoconjunctivitis Quality of Life Questionnaire With Standardised Activities (RQLQ[S])|RQLQ(S) is a 28-item, self-administered, disease-specific (allergic rhinitis), quality of life instrument that assesses quality of life over a 1-week interval. Each question is scored from 0 (not impaired at all) to 6 (severely impaired), with higher scores indicating more impairment on quality of life. RQLQ(S): Possible score ranges from 0 to 6. Change from baseline is calculated as the score at the endpoint minus the score at baseline.|Baseline and Week 4|ITT Population||Points on a scale||Standard Error|Least Squares Mean
757659|NCT00609674|Secondary|Mean Change From Baseline Over the Entire Treatment Period in Both the Individual AM Reflective and PM Reflective Ocular Symptom Scores for Eyes Itching/Burning, Eyes Tearing/Watering, and Eye Redness|The rTOSS is a rating of the severity of symptoms over the previous 12 hrs. and was performed in the AM (AM rTOSS) and PM (PM rTOSS). Each symptom is scored on a scale of 0 (none) to 3 (severe), with a total possible score of 0 to 9. Change from baseline is calculated as the score at the end of study minus the score at baseline.|Daily; Baseline through End of Study (Week 4)|||Points on a scale||Standard Error|Least Squares Mean
757660|NCT00609674|Secondary|Individual Ocular Symptoms: Mean Change From Baseline Over the Entire Treatment Period in Both the Individual, Daily Reflective and the AM, Pre-dose Instantaneous Ocular Symptom Scores for Eyes Itching/Burning, Eyes Tearing/Watering, and Eye Redness.|The rTOSS is a rating of the severity of symptoms over the previous 12 hrs. and was performed in the AM (AM rTOSS) and PM (PM rTOSS). The AM, pre-dose iTOSS is the sum of the 3 individual ocular symptom scores (scored on a scale of 0 [none] to 3 [severe], with a total possible score of 0 to 9) for eyes itching/burning, eyes tearing/watering, and eye redness, performed immediately prior to taking the daily dose. Change from baseline is calculated as the score at the end of study minus the score at baseline.|Daily; Baseline through End of Study (Week 4)|ITT Population||Points on a scale||Standard Error|Least Squares Mean
757661|NCT00609674|Secondary|Total Ocular Symptoms: Mean Percent Change From Baseline Over the Entire Treatment Period in Both the Daily rTOSS and the AM, Pre-dose iTOSS|The rTOSS is a rating of the severity of symptoms over the previous 12 hours and was performed in the AM (AM rTOSS) and PM (PM rTOSS). AM, pre-dose iTOSS: sum of the 3 individual ocular symptom scores (scored on a scale of 0 [none] to 3 [severe], with a total possible score of 0 to 9) for eyes itching/burning, eyes tearing/watering, and eye redness, performed immediately prior to taking the daily dose. Change from baseline is calculated as the score at the end of study minus the score at baseline.|Daily; Baseline through End of Study (Week 4)|ITT Population||percent change||Standard Error|Least Squares Mean
757662|NCT00609674|Secondary|Total Ocular Symptoms: Mean Change From Baseline Over the Entire Treatment Period in Both the AM Reflective Total Ocular Symptom Scores (rTOSS) and PM rTOSS|The rTOSS is a rating of the severity of symptoms over the previous 12 hours and was performed in the AM (AM rTOSS) and PM (PM rTOSS). Change from baseline is calculated as the score at the end of study minus the score at baseline. Each symptom is scored on a scale of 0 (none) to 3 (severe), with a total possible score of 0 to 9.|Daily; Baseline through End of Study (Week 4)|ITT Population||Points on a scale||Standard Error|Least Squares Mean
757663|NCT00609674|Secondary|Total Ocular Symptoms: Mean Change From Baseline Over the Entire Treatment Period in AM, Pre-dose Instantaneous Total Ocular Symptom Scores (iTOSS)|The AM, pre-dose iTOSS is the sum of the 3 individual ocular symptom scores for eyes itching/burning, eyes tearing/watering, and eye redness, performed immediately prior to taking the daily dose; each symptom is scored on a scale of 0 (none) to 3 (severe), with a total possible score of 0 to 9. Change from baseline is calculated as the score at the end of study minus the score at baseline.|Daily; Baseline through End of Study (Week 4)|ITT Population||Points on a scale||Standard Error|Least Squares Mean
757664|NCT00609674|Secondary|Mean Change From Baseline Over the Entire Treatment Period in Both Individual AM Reflective and PM Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion, Nasal Itching, and Sneezing.|The rTNSS is a rating of the severity of symptoms over the previous 12 hours and was performed in the AM (AM rTNSS) and PM (PM rTNSS). Change from baseline is calculated as the score at the end of study minus the score at baseline. Each symptom is scored on a scale of 0 (none) to 3 (severe), with a total possible score of 0 to 12.|Daily; Baseline through End of Study (Week 4)|ITT Population||Points on a scale||Standard Error|Least Squares Mean
757665|NCT00609674|Secondary|Individual Nasal Symptoms: Mean Change From Baseline Over the Entire Treatment Period in Individual Daily Reflective Nasal Symptom Scores and AM, Pre-dose Instantaneous Nasal Symptom Scores for Rhinorrhea, Nasal Congestion, Nasal Itching, and Sneezing|The rTNSS is a rating of the severity of symptoms over the previous 12 hours and was performed in the AM (AM rTNSS) and PM (PM rTNSS). The AM, pre-dose iTNSS is the sum of the 4 individual nasal symptom score assessments for rhinorrhea, nasal congestion, nasal itching, and sneezing performed immediately prior to taking the daily dose. Change from baseline is calculated as the score at the end of study minus the score at baseline. Each symptom is scored on a scale of 0 (none) to 3 (severe), with a total possible score of 0 to 12.|Daily; Baseline through End of Study (Week 4)|ITT Population||Points on a scale||Standard Error|Least Squares Mean
757666|NCT00609674|Secondary|Total Nasal Symptoms: Mean Percent Change From Baseline Over the Entire Treatment Period in Daily rTNSS and AM, Pre-dose iTNSS|The rTNSS is a rating of the severity of symptoms over the previous 12 hours and was performed in the AM (AM rTNSS) and PM (PM rTNSS). AM, pre-dose iTNSS: sum of the 4 individual nasal symptom score assessments for rhinorrhea, nasal congestion, nasal itching, and sneezing performed at the moment immediately prior to taking the daily dose. Each symptom is scored on a scale of 0 (none) to 3 (severe), with a total possible score range of 0 to 12. Change from baseline is calculated as the score at the end of study minus the score at baseline.|Daily; Baseline through End of Study (Week 4)|ITT Population||percent change||Standard Error|Least Squares Mean
757667|NCT00609674|Secondary|Total Nasal Symptoms: Mean Change From Baseline Over the Entire Treatment Period in PM rTNSS|TNSS is the sum of symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing (each scored on a scale of 0 [none] to 3 [severe]; total possible score of 0 to 12). The rTNSS (performed in the morning [AM] and evening [PM]) is a rating of the severity of symptoms over the previous 12 hours. Change from baseline is calculated as the score at the end of study minus the score at baseline.|Daily; Baseline through End of Study (Week 4)|ITT Population||Points on a scale||Standard Error|Least Squares Mean
757668|NCT00609674|Secondary|Total Nasal Symptoms: Mean Change From Baseline Over the Entire Treatment Period in AM rTNSS|TNSS = the sum of symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing (each scored on a scale of 0 [none] to 3 [severe]; total possible score of 0 to 12). The rTNSS (performed in the morning [AM] and evening [PM]) is a rating of the severity of symptoms over the previous 12 hours. Change from baseline is calculated as the score at the end of study minus the score at baseline.|Daily; Baseline through End of Study (Week 4)|ITT Population||Points on a scale||Standard Error|Least Squares Mean
757731|NCT00610129|Primary|Objective Response Rate (ORR)|in patients with metastatic carcinoid tumors and in metastatic islet cell tumors (parallel cohorts) when treated with MK-0646 alone.|2 years|||participants|||Number
757669|NCT00609674|Primary|Mean Change From Baseline Over the Entire Treatment Period in Daily Reflective Total Nasal Symptom Scores (rTNSS)|TNSS is the sum of symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing (each scored on a scale of 0 [none] to 3 [severe]; total possible score of 0 to 12). The rTNSS (performed in the morning [AM] and evening [PM]) was a rating of the severity of symptoms over the previous 12 hours. The daily rTNSS was the average of the AM rTNSS and PM rTNSS assessments. Change from baseline is calculated as the score at the end of study minus the score at baseline.|Daily; Baseline through End of Study (Week 4)|Intent-to-Treat (ITT) Population: all randomized subjects who received at least one dose of study drug||Points on a scale||Standard Error|Least Squares Mean
757670|NCT00609674|Secondary|Mean Change From Baseline Over the Entire Treatment Period in Daily Reflective Total Ocular Symptom Scores (rTOSS)|The TOSS is equal to the sum of the three individual ocular symptom scores for eye itching/burning, eye tearing/watering, and eye redness, where each symptom is scored on a scale of 0 (none) to 3 (severe); total possible score of 0 to 9. Change from baseline is calculated as the score at the end of study minus the score at baseline.|Daily; Baseline through End of Study (Week 4)|ITT Population||Points on a scale||Standard Error|Least Squares Mean
757671|NCT00609674|Secondary|Mean Change From Baseline Over the Entire Treatment Period in Morning (AM), Pre-dose Instantaneous Total Nasal Symptom Score (iTNSS)|The AM, pre-dose iTNSS is the sum of the 4 individual nasal symptom score assessments for rhinorrhea, nasal congestion, nasal itching, and sneezing performed at the moment immediately prior to taking the daily dose; each symptom is scored on a scale of 0 (none) to 3 (severe). Change from baseline is calculated as the score over the entire treatment period minus the score at baseline. TNSS: Total possible score ranges from 0 to 12.|Daily; Baseline through End of Study (Week 4)|ITT Population||Points on a scale||Standard Error|Least Squares Mean
757672|NCT00609739|Secondary|Patients Who Relapsed|Number of patients whose disease relapsed.|1 Year|||participants|||Number
757673|NCT00609739|Secondary|Patients With Graft-Versus-Host-Disease|Number of patients who exhibited acute and/or chronic graft-versus-host disease.|Up to 30 Days Post Study Treatment|||participants|||Number
757674|NCT00609739|Secondary|Patients With Regimen-Related Toxicity|Number of patients with adverse events related to treatment.|Up to 30 Days Post Study Treatment|||participants|||Number
757675|NCT00609739|Primary|Disease-free Survival|Number of patients who were free of disease and alive at 1 year.|1 year|||Participants|||Number
757676|NCT00609765|Secondary|The Number of Participants With Radiographic Response|Objective Radiographic Response Rate (ORR). We planned to calculate the sum of complete response (CR) and partial response (PR) in target lesions.|2 years||||||
757677|NCT00609765|Primary|Number of Participants With Progression Free Survival (PFS) at 12 Months|We planned to calculate the One Year Progression Free Survival rate. The event for PFS analyses was the first occurrence of disease progression or death and patients who did not progress or died would be censored at the date of last tumor evaluation (e.g. one-year).|12 months|Per protocol at 12 months|||||
757678|NCT00609804|Secondary|Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability|Defined as the number of participants with treatment-emergent grade 3/4 adverse events utilizing the National Cancer Institute Common Technology Criteria for Adverse Events (NCI CTCAE) v3.0|18 months|All patients on study||participants|||Number
757679|NCT00609804|Secondary|Overall Response Rate|The Number of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|18 months|All patients on study||participants|||Number
757680|NCT00609804|Primary|Progression-free Survival (PFS)|The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|18 months|All patients on study||months||95% Confidence Interval|Median
757681|NCT00609869|Secondary|Median Time to Treatment Failure (TTF)|The time from start of therapy to death, Progressive Disease (PD) or initiation of next therapy. PD: at least one of the NCI-WG criteria of Group A or Group B has to be met.|Up to 6 years|All evaluable chronic lymphocytic leukemia participants||months||95% Confidence Interval|Median
757682|NCT00609869|Secondary|Clinical Benefit Rate|The ORR rate plus Stable Disease (SD). NCI-WG: SD is the absence of progressive disease (PD) and failure to achieve at least a PR; PD: at least one of the criteria of Group A or Group B has to be met.|Up to 6 years|All evaluable chronic lymphocytic leukemia participants||percentage of participants|||Number
757683|NCT00609869|Primary|Overall Response Rate (ORR)|The sum of Complete Remission (CR) plus Partial Remission (PR) rates. Duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, and must be confirmed greater than 8 weeks after first meeting CR or PR criteria. Response and progression for Chronic Lymphocytic Leukemia (CLL) were evaluated using 2008 updated National Cancer Institute-Sponsored Working Group Guidelines (NCI-WG) for Chronic Lymphocytic Leukemia. CR: all of the criteria must be met, and patients have the lack disease-related constitutional symptoms: PR: at least two of the criteria of Group A plus one of the criteria of group B have to be met. Group A Parameters: Lymphadenopathy; Hepatomegaly; Splenomegaly; Blood; Lymphocytes; Marrow. Group B Parameters: Platelet count; Hemoglobin; Neutrophils.|Up to 6 years|All evaluable chronic lymphocytic leukemia participants||percentage of participants|||Number
757684|NCT00609947|Primary|Major Adverse Cardiac Events (MACE) Rate|Major Adverse Cardiac Events rate at 12 months post-procedure defined as death, target-vessel Myocardial Infarction (Q wave and non-Q wave), emergent cardiac bypass surgery, or target lesion revascularization, repeat percutaneous transluminal coronary angioplasty or cardiac bypass surgery.|12 months post-procedure|"12-month MACE Rate was compared to a 20% performance goal.
1st 97 subjects enrolled and implanted with 2.25mm stents
1st 39 subjects enrolled and implanted with 2.5mm stents
1st 40 subjects enrolled and implanted with 2.75mm stents
A supplemental safety analysis group of subjects with 2.25mm stents N=38 (included in 2.25mm group N=135)"||Percentage||95% Confidence Interval|Number
772064|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 6|Subject Satisfaction - hardness of erection when inflated|6 months post-surgery|||% satisfactory or somewhat satisfactory|||Number
757685|NCT00609947|Primary|In-segment Percent Diameter Stenosis at 8 Months Post-procedure|In-segment percent diameter stenosis at 8 months post-procedure with percent diameter stenosis defined as the value calculated as 100 x (RVD – Minimal Lumen Diameter (MLD)/RVD using the mean values from two orthogonal views (when possible) by Qualitative Coronary Angiography (QCA).|8 months post-procedure|The primary analysis sample consisted of 176 subjects (ITT) including the first 97 subjects with 2.25 mm, 39 subjects with 2.50 mm and 40 subjects with 2.75mm stents who met the study entry criteria, signed the written informed consent, and were enrolled in the trial.||percent diameter stenosis||95% Confidence Interval|Mean
757686|NCT00603733|Secondary|Frequency of Adverse Events|Safety dataset represents all patients in all study phases exposed to study drug at anytime during study. Safety dataset was a combination of the active, run-in and maintenance phases and therefore it is not possible to report the adverse events per phase.|From baseline to week 24|Safety dataset for Active and Maintenance Phases||percentage of patients with TEAEs|||Number
757687|NCT00603733|Primary|Maintenance Phase: Proportion of Subjects Experiencing Relapse|Relapse is defined as a UCDAI score of at least 3 and a score of at least 1 for endoscopy|Up to week 24|Per Protocol Analysis Set||% of subjects with relapse (90% CI)||90% Confidence Interval|Number
757688|NCT00603733|Primary|Active Phase: Proportion of Active Subjects Achieving Overall Improvement|"Overall improvement is defined as either a complete remission or a clinical response to therapy as measured by the Ulcerative Colitis Disease Activity Index (UCDAI).
Complete remission is defined as: i) a score of 0 or 1 for stool frequency; ii) a score of 0 for rectal bleeding; iii) a score of 0 for endoscopy findings and iv) a Physician's Global Assessment (PGA) score of 0 or 1.
A clinical response to therapy in the active disease phase is defined as i) improvement in the baseline PGA score; ii) improvement in endoscopy findings and in at least one other clinical assessment (stool frequency, rectal bleeding); iii) no worsening in any other clinical assessment; iv) a decrease of 2 or more points on the UCDAI score."|From baseline to week 8|Per Protocol Analysis Set||percentage of participants||90% Confidence Interval|Number
757689|NCT00603746|Secondary|Change From Baseline in Heart Rate at Week 8|Change from Baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed.||Beats per minute||Standard Deviation|Mean
757690|NCT00603746|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 8|Change from Baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed.||Millimeters of mercury (mmHg)||Standard Deviation|Mean
757691|NCT00603746|Secondary|24-hour Urinary Cortisol Excretion at Baseline and Week 8|A 24-hour urine sample was collected for the measurement of 24-hour urinary cortisol excretion at the following scheduled time points: within 7 days prior to Study Visit 3 (Baseline; Week 0) and Study Visit 8 (Week 8). The Baseline value for 24-hour urinary cortisol was taken from Visit 3.|Baseline and Week 8|Urine Cortisol (UC) Population: all participants whose urine samples did not have confounding factors that could affect the interpretation of results||Nanomoles per 24 hours (nmol/24 hours)||Full Range|Median
757692|NCT00603746|Secondary|Urine pH at Baseline and Week 8/Early Withdrawal|Urine samples were collected for the measurement of urine pH by dipstick method at Baseline and at Week 8/Early Withdrawal. The Baseline value was the measurement taken at screening (Visit 1). Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).|Baseline and Week 8/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||scores on a scale||Standard Deviation|Mean
757693|NCT00603746|Secondary|Urine Specific Gravity at Baseline and Week 8/Early Withdrawal|Urine samples were collected for the measurement of urine specific gravity by dipstick method at Baseline and at Week 8/Early Withdrawal. The Baseline value was the measurement taken at screening (Visit 1). Specific gravity is a measure of the amount of material dissolved in the urine. Specific gravity is the ratio of the density (mass of a unit volume) of a substance to the density (mass of the same unit volume) of a reference substance. Normal urine has a specific gravity between 1.010 and 1.020.|Baseline and Week 8/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||ratio||Standard Deviation|Mean
757694|NCT00603746|Secondary|Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal|Urinalysis parameters included: Urine Occult Blood (UOB), Urine Glucose (UG), Urine Ketones (UK), Urine Protein (UP), and Urine Leukocyte Esterase test for detecting White Blood Cells (UWBC). The dipstick was a strip used to detect the presence or absence of these parameters in the urine sample. The dipstick test gives results in a semi-quantitative manner; results for urinalysis parameters can be read as 1+, 2+, 3+, Large, Moderate, Negative (Neg), Small, and Trace. For UG, the result can be read as Neg, Trace, Trace or 1/10 grams per deciliter (G/dL), 1+ or 1/4 G/dL, 2+ or 1/2 G/dL, 3+ or 1 G/dL, 4+ or 2 or more G/dL, indicating proportional concentrations in the urine sample. Data are reported as the number of participants who had 1+, 2+, 3+, Large, Moderate, Neg, Small, or Trace levels at Baseline (BL) and Week 8 (W8)/Early Withdrawal (EW). The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||participants|||Number
757732|NCT00610155|Secondary|Doleur Neuropathic 4 (DN4) Score|DN4 questionnaire provides a simple diagnosis of Neuropathic pain (NeP) by asking for yes/no answers to 4 questions (10 sub questions in total). Each question was scored on a scale of 0 (No) and 1 (Yes). Total score was calculated as sum of the 10 individual questions. Total score range 0-10, higher score indicated more neuropathic pain.|Day -35|Data for this outcome measure was plotted against treatment for each participant as per planned analysis but not statistically summarized for analysis.|||||
757695|NCT00603746|Secondary|Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8|Blood samples were collected for the measurement of creatinine, direct bilirubin (DBIL), total bilirubin (TBIL), and uric acid at Baseline and Week 8. The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||Micromoles per liter (µmol/L)||Standard Deviation|Mean
757696|NCT00603746|Secondary|Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8|Blood samples were collected for the measurement of calcium, carbon dioxide content/bicarbonate (CO2/BI), chloride, cholesterol, glucose, phosphorus inorganic (PI), potassium, sodium, and urea at Baseline and Week 8. The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||Millimoles per liter (mmol/L)||Standard Deviation|Mean
757697|NCT00603746|Secondary|Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8|Blood samples were collected for the measurement of albumin and total protein at Baseline and Week 8. The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||Grams per liter (g/L)||Standard Deviation|Mean
757698|NCT00603746|Secondary|Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8|Blood samples were collected for the measurement of ALT, ALP, AST, GGT, and LDH at Baseline and Week 8. The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||International units per liter (IU/L)||Standard Deviation|Mean
757699|NCT00603746|Secondary|Red Blood Cell Count at Baseline and Week 8|Blood samples were collected for determining the red blood cell count at Baseline and Week 8. The Baseline value was the measurement taken at screening (Visit1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||10^12 cells per liter (TI/L)||Standard Deviation|Mean
757700|NCT00603746|Secondary|Platelet Count and White Blood Cell Count at Baseline and Week 8|Blood samples were collected for determining the platelet count and white blood cell (WBC) count at Baseline and Week 8. The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||10^9 cells per liter (GI/L)||Standard Deviation|Mean
757701|NCT00603746|Secondary|Hemoglobin at Baseline and Week 8|Blood samples were collected for the measurement of hemoglobin at Baseline and Week 8. The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Grams per liter (G/L)||Standard Deviation|Mean
757702|NCT00603746|Secondary|Hematocrit at Baseline and Week 8|Blood samples were collected for the measurement of hematocrit at Baseline and Week 8. The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Proportion of 1||Standard Deviation|Mean
757703|NCT00603746|Secondary|Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8|Blood samples were collected for the measurement of the percentage of basophils, eosinophils, lymphocytes, monocytes, and total neutrophils in the blood at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||Percentage in the blood||Standard Deviation|Mean
757704|NCT00603746|Secondary|Number of Participants With Clinical/Visual Evidence of Oropharyngeal Candidiasis|A detailed oropharyngeal examination for visual evidence of oral candidiasis was performed.|From Baseline up to Week 8/Early Withdrawal|ITT Population||participants|||Number
757705|NCT00603746|Secondary|Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event Throughout the 8-week Treatment Period|An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; or is a congenital anomaly/birth defect. Medical or scientific judgment should have been exercised in other situations. Refer to the general AE/SAE module for a list of AEs (occurring at a frequency threshold >=3%) and SAEs.|From the first dose of the study medication up to Week 8/Early Withdrawal|ITT Population||participants|||Number
772065|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 6|Subject Satisfaction - hardness of erection when inflated|3 months post-surgery|||% satisfactory or somewhat satisfactory|||Number
757707|NCT00603746|Secondary|Mean Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods During the 8-week Treatment Period|The number of inhalations of rescue albuterol/salbutamol inhalation aerosol used during the day and night was recorded by the participants in a daily diary. A 24-hour period in which a participant’s responses to both the morning and evening assessments indicated no use of rescue medication was considered as rescue-free. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 8-week Treatment Period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of Baseline, country, sex, age, and treatment group.|From Baseline up to Week 8|ITT Population. Only those participants available at the specified time points were analyzed.||Percentage of rescue-free 24-hr periods||Standard Error|Least Squares Mean
757708|NCT00603746|Secondary|Mean Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 8-week Treatment Period|Asthma symptoms were recorded in a daily dairy by the participants every day in the morning and evening before taking any rescue or study medication and before PEF measurement. A 24-hour period in which a participant’s responses to both the morning and evening assessments indicated no symptoms was considered as symptom-free. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 8-week Treatment Period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of Baseline, country, sex, age, and treatment group.|From Baseline up to Week 8|ITT Population. Only those participants available at the specified time points were analyzed.||Percentage of symptom-free 24-hr periods||Standard Error|Least Squares Mean
757709|NCT00603746|Secondary|Mean Change From Baseline in Daily Morning PEF Averaged Over the 8-week Treatment Period|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Trough PEF is defined as the maximal rate (speed) that a person can exhale during a short maximal expiratory effort after a full inspiration. PEF was measured by the participants using a hand-held electronic peak flow meter each morning prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. The best of three attempts was recorded by the participants in a daily diary. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the value of the averaged daily morning PEF over the 8-week treatment period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of Baseline trough morning PEF, country, sex, age, and treatment group.|From Baseline up to Week 8|ITT Population. Only those participants available at the specified time points were analyzed.||Liters per minute||Standard Error|Least Squares Mean
757710|NCT00603746|Secondary|Mean Change From Baseline in Daily Trough (Pre-dose and Pre-rescue Bronchodilator) Evening Peak Expiratory Flow (PEF) Averaged Over the 8-week Treatment Period|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Trough PEF is defined as the maximal rate (speed) that a person can exhale during a short maximal expiratory effort after a full inspiration. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. The best of three attempts was recorded by the participants in a daily diary. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the value of the averaged daily evening PEF over the 8-week treatment period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of Baseline trough evening PEF, country, sex, age, and treatment group.|From Baseline up to Week 8|ITT Population. Only those participants available at the specified time points were analyzed.||Liters per minute||Standard Error|Least Squares Mean
757711|NCT00603746|Primary|Mean Change From Baseline in Trough (Evening Pre-dose and Pre- Rescue Bronchodilator) FEV1 at Week 8|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcibly exhaled from the lungs in one second. Pre-dose and pre-rescue bronchodilator (albuterol/salbutamol) trough FEV1 (the measurement of FEV1 performed at the end of the dosing interval) was measured electronically by spirometry in the evening at the Baseline (BL) through Week 8 clinic visits. The highest of 3 technically acceptable measurements was recorded. The Visit 3 FEV1 assessment was used as the Baseline value. Change from Baseline in trough FEV1 was calculated as the value at Week 8 minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of Baseline trough FEV1, country, sex, age, and treatment group.|Baseline and Week 8|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study medication. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-BL on-treatment measurement (scheduled and unscheduled visits) was used to impute missing measurements.||Liters||Standard Error|Least Squares Mean
757712|NCT00603798|Secondary|Local Skin Reactions (LSR)|Six local skin reaction (LSR) signs were predefined and were assessed for presence and intensity at each visit. These included: Erythema, edema, Weeping/Exudate, Flaking/Scaling/Dryness, Scabbing/Crusting and Erosion/Ulceration. The LSRs were scored as 0=none, 1=mild, 2=moderate, 3=severe. Summary of LSR - area under the curve (AUC) of sum of LSR scores (days).|The time period for the AUC extends to 8 weeks after the end of treatment (Week 17)|All participants were evaluated for local skin reactions (LSR) at every visit. The ITT population was used. Only subjects who received treatment in both cycles are included in the analysis.||units on a scale * days||Standard Deviation|Mean
757713|NCT00603798|Secondary|Percent Change From Baseline in AK Lesion Count|Percent change from Baseline to end of study (EOS) in investigator counts of AK lesions. A negative percent change is better than a positive percent change.|At all visits - Baseline through the Week 17 EOS visit|Intent to treat (ITT) population using last observation carried forward (LOCF).||percentage of participants||Full Range|Median
757714|NCT00603798|Secondary|Number of Participants With Partial Clearance of AK Lesions|Subject status with respect to complete clearance of AK lesions at End of Study (EOS), defined as at least a 75% reduction in the number of AK lesions in the treatment area compared with Baseline.|End of Study the Week 17 visit|Efficacy analyses were conducted on the intent-to-treat (ITT) population. Imputations were made for missing data points using last observation carried forward (LOCF).||participants|||Number
758087|NCT00612573|Secondary|Absolute Change From Baseline to Week 12 in Total Lesion Count, ITT Population|Total Lesion Count is the sum of inflammatory and noninflammatory lesions.|Baseline to Week 12|ITT Population||Lesions||Standard Deviation|Mean
757715|NCT00603798|Primary|Number of Participants With Complete Clearance of AK Lesions|"Subject status with respect to complete clearance of AK lesions at End of Study (EOS), ie, the Week 17 visit. Complete clearance was defined as the absence of clinically visible or palpable AK lesions in the treatment area. All lesions within the identified treatment area were included in the count, even if the lesion was a new lesion or subclinical lesion that had not been identified at Baseline."|End of Study the Week 17 visit|Efficacy analyses were conducted on the intent-to-treat (ITT) population. For the primary efficacy variable, imputations were made for missing data points using last observation carried forward (LOCF), primary analysis), taking all missed observations as failure (sensitivity analysis), and using observed cases only (supportive analysis).||participants|||Number
757716|NCT00603837|Primary|Neonatal Intensive Care Unit (NICU) Admission Temperature|Axillary temperature of the infant upon arrival to the neonatal intensive care unit.|At time of admission to the NICU - usually within 10-15 min of birth|||Celsius degrees||Standard Deviation|Mean
757717|NCT00603889|Secondary|1000 Mcg/ml Na-ASP-2 Intradermal Skin Test|"Mean grade of wheal reaction after 2 applications of the skin test reagent per participant. For each skin test reaction, the grade of the test was determined based on the mean of the longest and orthogonal diameters, which was then compared to the equivalent measurements of a histamine solution positive control that was applied at the same time as the test. Grading was as follows:
0 no discernible wheal
< ½ histamine diameter
≥ ½ histamine; < histamine diameter
= size of histamine control ± 1 mm
> histamine diameter; < 2x diameter
≥ 2x histamine control"|15 minutes after skin test application|||units on a scale||Full Range|Mean
757718|NCT00603889|Secondary|100 Mcg/ml Na-ASP-2 Intradermal Skin Test|"Mean grade of wheal reaction after 2 applications of the skin test reagent per participant. For each skin test reaction, the grade of the test was determined based on the mean of the longest and orthogonal diameters, which was then compared to the equivalent measurements of a histamine solution positive control that was applied at the same time as the test. Grading was as follows:
0 no discernible wheal
< ½ histamine diameter
≥ ½ histamine; < histamine diameter
= size of histamine control ± 1 mm
> histamine diameter; < 2x diameter
≥ 2x histamine control"|15 minutes after skin test application|||units on a scale||Full Range|Mean
757719|NCT00603889|Secondary|1000 Mcg/ml Na-ASP-2 Prick-puncture Skin Test|"Mean grade of wheal reaction after 2 applications of the skin test reagent per participant. For each skin test reaction, the grade of the test was determined based on the mean of the longest and orthogonal diameters, which was then compared to the equivalent measurements of a histamine solution positive control that was applied at the same time as the test. Grading was as follows:
0 no discernible wheal
< ½ histamine diameter
≥ ½ histamine; < histamine diameter
= size of histamine control ± 1 mm
> histamine diameter; < 2x diameter
≥ 2x histamine control"|15 minutes after skin test application|||units on a scale||Full Range|Mean
757720|NCT00603889|Primary|100 Mcg/ml Na-ASP-2 Prick-puncture Skin Test|"Mean grade of wheal reaction after 2 applications of the skin test reagent per participant. For each skin test reaction, the grade of the test was determined based on the mean of the longest and orthogonal diameters, which was then compared to the equivalent measurements of a histamine solution positive control that was applied at the same time as the test. Grading was as follows:
0 no discernible wheal
< ½ histamine diameter
≥ ½ histamine; < histamine diameter
= size of histamine control ± 1 mm
> histamine diameter; < 2x diameter
≥ 2x histamine control"|15 minutes after skin test application|||Units on a scale||Full Range|Mean
757723|NCT00603915|Secondary|Number of Participants With the Responses Outlined|"Complete Response (CR): disappearance of all clinical and radiological evidence of tumour.
Partial Response (PR): at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD.
Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Progressive Disease (PD): at least a 20% increase in the sum of LD of measured lesions taking as references the smallest sum LD recorded since the treatment started. Appearance of new lesions will also constitute progressive disease."|Measured every 2 cycles until the participant is off treatment.|||Participants|||Number
757724|NCT00603915|Primary|Progression Free Survival.|From randomization to the first documented disease progression or death from any cause, whichever came first, assessed until all participants randomized to the study have progressed for died.|From the on-study date until the date of first documented progression or date of death from any cause any cause until all participants have progressed or died.|||Months||95% Confidence Interval|Mean
757725|NCT00609973|Secondary|Endoscopic Recurrence Under Postoperative Treatment With Study Medication at 6 Months||6 months|Endoscopy 6 months, Intention-to-Treat analysis, patients not undergoing endoscopy were assumed to have endoscopic recurrence||participants|||Number
757726|NCT00609973|Primary|Safety and Tolerability of Ciprofloxacin|Adverse events (AE) Discontinuation of study drug due to probably study drug related AE|6 Months|Intention to Treat analysis.Adverse events (AE), which were classified as probably or possibly related to the study drug.||Adverse events|||Number
757727|NCT00609986|Secondary|Severe Hyperglycemia|Blood glucose greater than 350 mg/dl.|30 months|The intent-to-treat analysis set consisted of the participants that underwent a renal transplant.||participants|||Number
757728|NCT00609986|Primary|Acute/Active Rejection|Grades IA through III and antibody immediate rejection, either A (immediate or hyperacute) or B (delayed or accelerated acute) were diagnosed and classified based on renal allograft biopsies according to the Banff 97 Working Classification of Renal Allograph Pathology.|30 months|The intent-to-treat analysis set consisted of the participants that underwent a renal transplant.||participants|||Number
757729|NCT00609986|Secondary|Severe Hypoglycemia|Blood glucose less than 40 mg/dl|30 months|The intent-to-treat analysis set consisted of the participants that underwent a renal transplant.||participants|||Number
758088|NCT00612573|Secondary|Absolute Change From Baseline to Week 12 in NonInflammatory Lesion Count, ITT Population|Noninflammatory Lesion Count includes open and closed comedones.|Baseline to Week 12|ITT Population||Lesions||Standard Deviation|Mean
757733|NCT00610155|Secondary|Present Pain Intensity Score (PPIS)|Participants answered: “Please rate your pain from 0-10 that best describes the intensity of pain right now”. PPIS assessed on 0-10 numeric rating scale (NRS), 0 (no pain) to 10 (worst possible pain).|Day 8, 22, 36|FAS included all the participants who were enrolled in the study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Error|Least Squares Mean
757734|NCT00610155|Secondary|Daily Pain Score|Daily Pain Score: Day 1 pain intensity over past 24 hours recorded on waking every morning using 0-10 numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain). The daily pain scores for an average of the last 7 days and an average of last 3 days were calculated.|Day -35 through Day 36|FAS included all the participants who were enrolled in the study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Error|Least Squares Mean
757735|NCT00610155|Secondary|Neuropathic Pain Symptom Inventory (NPSI)|NPSI: participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicate a greater intensity of pain.|Baseline (Day -7), Day 8, 22, 36|Data for this outcome measure was plotted against treatment for each participant as per planned analysis but not statistically summarized for analysis.|||||
757736|NCT00610155|Secondary|Pain Catastrophising Scale (PCS)|The PCS is a self-administered questionnaire with 13 items, each scored from 0 (not at all) to 4 (all the time) for extent to which participant catastrophizes postoperative pain. Total score is sum of scores for all questions (range: 0 to 52); Subscale scores: Rumination (sum of scores for 4 items; range: 0 to 16); Magnification (sum of scores for 3 items; range: 0 to 12); and Helplessness (sum of scores for 6 items; range: 0 to 24); higher scores indicate greater extent of pain catastrophizing.|Day 8, 22, 36|Data for this outcome measure was plotted against treatment for each participant as per planned analysis but not statistically summarized for analysis.|||||
757737|NCT00610155|Secondary|State and Trait Anxiety Questionnaire|Self-report scale completed by the participant. Separate scales measure state (20 items) and trait (20 items) anxiety. The participant report how they feel “right now at this moment” for state anxiety and how they “generally” feel for trait anxiety. The “state” items are scored as: 1 (not at all), 2 (somewhat true), 3 (moderately true), 4 (very much so). The “trait” items are scored as: 1 (almost never), 2 (sometimes), 3 (often), 4 (almost always). Scores range from 20-80 for each scale. Higher scores indicate more impaired participants.|Day 8, 22, 36|Data for this outcome measure was plotted against treatment for each participant as per planned analysis but not statistically summarized for analysis.|||||
757738|NCT00610155|Secondary|Beck Depression Inventory (BDI)|BDI is a 21 item participant rated inventory evaluating depression symptoms, cognition, and physical symptoms of fatigue, weight loss, lack of interest in sex. Individual items are scored on a 4 point scale (0 to 3), with 0=none/absent and 3=most severe. Total score: 0 to 63; higher score indicate more depression.|Day 8, 22, 36|Data for this outcome measure was plotted against treatment for each participant as per planned analysis but not statistically summarized for analysis.|||||
757739|NCT00610155|Secondary|36-Item Short-Form Health Survey (SF-36)|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Day 8, 22, 36|Data for this outcome measure was plotted against treatment for each participant as per planned analysis but not statistically summarized for analysis.|||||
757740|NCT00610155|Primary|Arterial Spin Labelling (ASL) Using fMRI of Brain Activation Signals Across the Whole Brain and in Defined Brain Regions|Continuous ASL sequence fMRI imaging modality assessing brain activation signals across the whole brain and in defined ROI to assess effects of evoked pain along with changes in regional cerebral blood flow (rCBF). ROI were ACC; AIC_L; AIC_R; MIC_L; MIC_R; PIC_L; PIC_R; Amyg_L; Amyg_R; S1; S2; SensTHAL; MRF; NucCun; PAG.|Day 8, 22, 36|Data was not analyzed since these methods were not technically robust enough to make any clear conclusions.|||||
757741|NCT00610155|Primary|Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Visual Stimulation (VIS)|BOLD brain activation signals in pre-defined ROI in response to checkerboard visual stimuli (flashing at 2 Hz). ROI were ACC; AIC_L; AIC_R; MIC_L; MIC_R; PIC_L; PIC_R; Amyg_L; Amyg_R; S1; S2; SensTHAL; MRF; NucCun; PAG. Prior to ROI analysis, a prelimanary anlysis was performed, wherein it was concluded that ROI analysis was to be carried out for DMAa, DMAc amd TH only.|Day 8, 22, 36|For VIS, based on preliminary analysis results, it was not considered significant to collect data according to Investigator's opinion.|||||
757742|NCT00610155|Primary|Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Thermal Stimulation (TH)|BOLD brain activation signals in pre-defined ROI. ROI were ACC; AIC_L; AIC_R; MIC_L; MIC_R; PIC_L; PIC_R; Amyg_L; Amyg_R; S1; S2; SensTHAL; MRF; NucCun; PAG. Prior to ROI analysis, a prelimanary anlysis was performed, wherein it was concluded that ROI analysis was to be carried out for DMAa, DMAc amd TH only. In voxel BOLD analysis, signal change is unit less measure but is approximated to percent signal change here by grand scaling (dividing effects by 10000 to get percent signal change).|Day 8, 22, 36|BOLD analysis set included all participants who completed all the 3 treatment periods of the study.||percent signal change||Standard Error|Least Squares Mean
757743|NCT00610155|Primary|Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Dynamic Mechanical Allodynia of the Control Side (DMAc)|BOLD brain activation signals in pre-defined ROI. ROI were ACC; AIC_L; AIC_R; MIC_L; MIC_R; PIC_L; PIC_R; Amyg_L; Amyg_R; S1; S2; SensTHAL; MRF; NucCun; PAG. Prior to ROI analysis, a prelimanary anlysis was performed, wherein it was concluded that ROI analysis was to be carried out for DMAa, DMAc amd TH only. In voxel BOLD analysis, signal change is unit less measure but is approximated to percent signal change here by grand scaling (dividing effects by 10000 to get percent signal change).|Day 8, 22, 36|BOLD analysis set included all participants who completed all the 3 treatment periods of the study.||percent signal change||Standard Error|Least Squares Mean
757744|NCT00610155|Primary|Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Dynamic Mechanical Allodynia of the Affected Side (DMAa)|BOLD brain activation signals in pre-defined region of interest(ROI):anterior cingulate cortex(ACC);left,right anterior cortex([AIC_L ],[AIC_R]);left,right mid-insular cortex([MIC_L],[MIC_R]);left,right posterior insular cortex([PIC_L],[PIC_R]);left,right amygdala([Amyg_L],[Amyg_R]);primary,secondary somatosensory cortex([S1],[S2]);sensory part of thalamus(SensTHAL);midbrain reticular formation(MRF);nucleus cuneiformis(NucCun);periaqueductal gray(PAG). Prior to ROI analysis, a prelimanary anlysis was performed, wherein it was concluded that ROI analysis was to be carried out for DMAa, DMAc amd TH only. In voxel BOLD analysis,signal change is unit less measure but approximated to percent signal change by grand scaling(effects divided by 10000 to get percent signal change).|Day 8, 22, 36|BOLD analysis set included all participants who completed all the 3 treatment periods of the study.||percent signal change||Standard Error|Least Squares Mean
757745|NCT00610155|Primary|Voxel-wise Blood Oxygen Level Dependent (BOLD) Using Functional Magnetic Resonance Imaging (fMRI) of Brain Activation Signals Across the Whole Brain|BOLD brain activation signals in whole brain was assessed using Contrast Parameter Estimates (COPE) images in response to dynamic mechanical allodynia of the affected side (DMAa), dynamic mechanical allodynia of the control side (DMAc), thermal pain (TH) and checkerboard visual stimuli (VIS).|Day 8, 22, 36|Data not available to report, as BOLD brain activation signals in whole brain were obtained as specific Contrast Parameter Estimates (COPE) images only, as per planned analysis.|||||
757746|NCT00610168|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|For safety assessment Boostrix I Group and Boostrix II Group were pooled (Pooled Group)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.||Subjects|||Number
757747|NCT00610168|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31-day (Day 0–30) follow-up period after booster vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.||Subjects|||Number
757748|NCT00610168|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], headache and gastrointestinal symptoms. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 4-day (Day 0–3) follow-up period after booster vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available and with the symptom sheet filled in.||Subjects|||Number
757749|NCT00610168|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.|During the 4-day (Day 0–3) follow-up period after booster vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available and with the symptom sheet filled in.||Subjects|||Number
757750|NCT00610168|Secondary|Number of Subjects With Booster Response to Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)|Booster response was defined as appearance of antibodies in subjects who were seronegative at the pre-vaccination time point (i.e. with concentrations < 5 El.U/mL) or at least 2-fold increase of prevaccination antibody concentrations in subjects who were seropositive at the pre-vaccination time point (i.e. with concentrations ≥5 El.U/mL.|At Month 1|The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine and for whom immunogenicity data were available.||Subjects|||Number
757751|NCT00610168|Secondary|Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EL.U/mL).|At Month 0 (PRE) and Month 1 (POST)|The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine and for whom immunogenicity data were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
757752|NCT00610168|Secondary|Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)|A seropositive subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 ELISA unit per milli-liter (EL.U/ml)|At Month 0 (PRE) and Month 1 (POST)|The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine and for whom immunogenicity data were available.||Subjects|||Number
757753|NCT00610168|Secondary|Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations|Concentrations are presented as international units per millilitre (IU/mL).|At Month 0 (PRE) and Month 1 (POST)|The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine and for whom immunogenicity data were available.||IU/mL||95% Confidence Interval|Geometric Mean
757754|NCT00610168|Primary|Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Above the Cut-offs|The antibody concentrations cut-offs assessed were: equal to or above (≥) 0.1 international units per milliliter (IU/mL) and ≥ 1 IU/mL.|At Month 1|The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine and for whom immunogenicity data were available.||Subjects|||Number
757755|NCT00610168|Primary|Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Above the Cut-offs|The antibody concentrations cut-offs assessed were: equal to or above (≥) 0.1 international units per milliliter (IU/mL) and ≥ 1 IU/mL.|At Month 0|The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine and for whom immunogenicity data were available.||Subjects|||Number
757756|NCT00610207|Primary|Fistula Closure (Tract Based)|"Fistula closure is defined as absence of drainage at the external fistula opening.
An anorectal fistula is an inflammatory tract or connection between the epithelialized surface of the anal canal and most frequently, the perianal skin or perineum. It is possible to have multiple fistula tracts present on a patient."|12 months|Three single tract fistula patients were lost to follow-up and were excluded from the analysis.||tracts|Participants||Number
757757|NCT00610207|Primary|Fistula Closure (Patient Based)|Fistula closure is defined as absence of drainage at the external fistula opening.|12 months|Three single tract fistula patients were lost to follow-up and were excluded from the analysis.||participants|||Number
757758|NCT00611247|Secondary|Toxicity Profile: Individual Subjects With Drug-related SAEs||12 months|||participants|||Number
757759|NCT00611247|Secondary|Toxicity Profile: Total Number of Drug-related Serious Adverse Events||12 months|||events|||Number
757760|NCT00611247|Primary|Response Rate (CR + CRi + LFS)|"Response determined per European LeukemiaNet response criteria:
CR = bone marrow blasts <5%; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count > 1.0 x 10e9/L; platelet count > 100 x 10e9/L; and independence of red cell transfusions.
CRi = all CR criteria except for residual neutropenia (< 1.0 x 10e9/L) or thrombocytopenia (< 100 x 10e9/L)].
Morphologic leukemia-free state (LFS) = bone marrow blasts <5%; absence of blasts with Auer rods; absence of extramedullary disease; with no hematologic recovery required.
Relapse = bone marrow blasts >5%; reappearance of blasts in the blood; or development of extramedullary disease."|up to 2 months|||participants|||Number
757761|NCT00611325|Secondary|Number of Patients With Grade 3 or Greater, Treatment-related, Non-hematologic Toxicities|Number of patients with grade 3 or greater, treatment-related, non-hematologic toxicities based on Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|60 months|||participants|||Number
757762|NCT00611325|Secondary|Radiographic Response Rate|The percentage of participants with a complete or partial response at any assessment as determined by the Macdonald criteria. A confirmation of response was not required. Per Macdonald criteria, complete response (CR) was the disappearance of all target lesions and partial response (PR) was a ≥50% decrease in the sum of the longest diameter of target lesions, no new lesions and stable or decreasing steroid dose. Objective response =CR+PR. Tumor assessments were done at baseline and at the end of each 6 week treatment cycle, and overall best response was recorded.|60 months|||percentage of participants||95% Confidence Interval|Number
757763|NCT00611325|Secondary|Median Overall Survival (OS)|Time in months from the start of study treatment to the date of death. Patients alive as of the last follow-up had OS censored at the last follow-up date. Median OS was estimated using a Kaplan-Meier curve.|Time in months from the start of study treatment to date of death due to any cause. Assessed up to 60 months.|||months||95% Confidence Interval|Median
757764|NCT00611325|Secondary|Median Progression Free Survival (PFS)|Time in months from the start of study treatment to the date of first progression according to Macdonald criteria, or to death due to any cause. Per Macdonald, progression is a ≥ 25% increase in the sum of the products of perpendicular diameters of enhancing lesions, any new lesion, or clinical deterioration. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve.|Time in months from the start of study treatment to the date of first progression or death. Assessed up to 60 months.|||months||95% Confidence Interval|Median
757765|NCT00611325|Primary|6-month Progression-free Survival (PFS)|Percentage of participants surviving six months from the initiation of treatment without progression of disease. PFS was defined as the time from the initiation of treatment to the date of the first documented progression according to the Macdonald criteria, or to death due to any cause. Per Macdonald, progression is a ≥ 25% increase in the sum of the products of perpendicular diameters of enhancing lesions, any new lesion or clinical deterioration.|6 months|||percentage of participants||95% Confidence Interval|Number
757766|NCT00611403|Secondary|Change From Baseline in Goblet Cell Density of the Eyes at Month 6|Change from baseline in goblet cell density of the eyes (better eye and worse eye) at month 6 of the Treatment Phase. Goblet cells are special cells in the eye that support a healthy tear film. A positive number change from baseline represents an increase in goblet cells (improvement).|Baseline, Month 6|Intent-to-Treat (ITT). The ITT population includes all patients who started the study (randomized).||Cells per square millimeter (cells/mm^2)||Full Range|Median
757767|NCT00611403|Secondary|Change From Baseline in Keratocyte Density in the Anterior Flap of the Eyes at Month 6|Change from baseline in keratocyte (specialized cells in the cornea activated after injury or inflammation) density (thickness) in the anterior flap of the eyes (better eye and worse eye) at month 6 of the Treatment Phase. A positive number change from baseline represents an increase in density (improvement). A negative number change from baseline represents a decrease in density (worsening).|Baseline, Month 6|Intent-to-Treat (ITT). The ITT population includes all patients who started the study (randomized).||Cells per cubic millimeter (cells/mm^3)||Standard Deviation|Mean
757768|NCT00611403|Primary|Percentage of Patients With Clinical Success at Month 6|Percentage of patients with clinical success at month 6. Clinical success is defined as the percentage of patients with corneal sensitivity (the capability of the cornea to respond to stimulation) >= 50 millimeters in all regions of the study eye at month 6 of the Treatment Phase.|Month 6|Modified Intent-to-Treat (mITT). The mITT population included all randomized and treated patients with a study eye having a corneal sensitivity measurement of < 25 mm in the 3 central regions of the eye on Day 2.||Percentage of Patients|||Number
757769|NCT00611442|Secondary|The Number of Polyps Detected on Examination|The number of colon polyps detected during the colonoscopy.|measured upon completion of the colonoscopy, colonoscopies completed during the course of the study (approximately 4 month period)|||number of polyps|||Number
757770|NCT00611442|Secondary|Procedure Time|Procedure time refers to the total length of time required to complete the colonoscopy|measured upon completion of the colonoscopy, colonoscopies completed during the course of the study (approximately 4 month period)|||minutes||Standard Deviation|Mean
757771|NCT00611442|Secondary|Patient Satisfaction With the Prep Measured by 5 Point Likert Scale|The participants completed a survey prior to the colonoscopy that graded their overall satisfaction with the bowel preparation. The subjects rated the survey questions on a 5-point Likert scale where 1 = severely distressing, 2=distressing, 3=bothersome, 4=mild, and 5=none.|measured after completion of the bowel preparation and prior to the colonoscopy, completed during the course of the study (approximately 4 month period)|||linkert scale (1-5)||Standard Deviation|Mean
757772|NCT00611442|Primary|The Overall Cleanliness of the Prep as Measured by the Ottawa Scale|Bowel cleansing was evaluated with the Ottawa bowel preparation scale by each endoscopist during the endoscopy. Neither the endoscopist nor the endoscopy nurse was aware of the bowel preparation used prior to the colonoscopy. The Ottawa bowel preparation scale is a validated tool and was used in this study to provide a reliable quality assessment of the bowel preparation used for colonoscopy. This validated scale rates each section of the colon, the right, the mid, and the rectosigmoid colon, on a 5-point scale (0–4), as well as a global 3-point rating for overall colonic fluid (0–2). The total score ranges from 0 to 14. An excellent preparation with little fluid would score 0–3, a good preparation 4–6, while scores higher than 7would indicate progressively worsening bowel preparations. A completely unprepared colon would score 11–14, depending on the amount of colonic fluid|measured upon completion of the colonoscopy, colonoscopies completed during the course of the study (approximately 4 month period)|||Ottawa Score||Full Range|Mean
757773|NCT00611455|Secondary|Number of Participants With the Indicated Hematology Values of Potential Clinical Concern During the Follow-up Period|Only those parameters for which at least one value of clinical concern (CC) was reported are summarized. Pre-defined limits of potential clinical concern (CC Low [relative to lower limit of normal], CC High [relative to upper limit of normal]) are: Eosinophils: NA, 2; Total neutrophils: 0.8, 1.6; Platelet count: 0.65, 1.5.|From the last scheduled visit in the DB or OL Period until B-cells and circulating IgG had returned to normal or baseline levels (maximum of 2 years)|AT Population. Only participants who withdrew from the DB Period and had evidence of contact with the site after the end of the DB Period and all participants who withdrew or completed the OL Period and had evidence of contact with the site after their end of OL date were analyzed.||Participants|||Number
757774|NCT00611455|Secondary|Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern During the Follow-up Period|Only those parameters for which at least one value of clinical concern (CC) was reported are summarized. Pre-defined limits of potential clinical concern (CC Low [relative to the lower limit of normal], CC High [relative to the upper limit of normal]) are: ALT: NA, 2; ALP: NA, 1.5; Creatinine: N/A, 1.2; CO2/BCO: 0.85/0.75, 1.2/1.3; CK: NA, 2; GGT: NA, 2; Urea/BUN: NA, 1.5.|From the last scheduled visit in the DB or OL Period until B-cells and circulating IgG had returned to normal or baseline levels (maximum of 2 years)|AT Population. Only participants who withdrew from the DB Period and had evidence of contact with the site after the end of the DB Period and all participants who withdrew or completed the OL Period and had evidence of contact with the site after their end of OL date were analyzed.||Participants|||Number
757775|NCT00611455|Secondary|Number of Participants With a Positive JC Virus Test Result During the Follow-up Period|Blood samples were collected for analysis of plasma/white blood cell JC Virus (JCV) using the polymerase chain reaction (PCR) assay. A positive JC Virus test result indicated the presence of JC Virus.|From the last scheduled visit in the DB or OL Period until B-cells and circulating IgG had returned to normal or baseline levels (or maximum of 2 years from LSLV)|AT Population. Only those participants contributing values at the indicated time point were analyzed.||Participants|||Number
757776|NCT00611455|Secondary|Time to First CD19+ B-cell Repopulation Relative to the First Dose and Last Dose of Ofatumumab|Time to first CD19+ B-cell repopulation (return to normal or baseline level) relative to the first dose was assessed only for those participants whose B-cells repopulated after receiving ofatumumab. Time to first CD19+ B-cell repopulation relative to the last dose of ofatumumab was assessed only for those participants whose B-cells repopulated during their last ofatumumab treatment course or follow-up.|From the first dose of ofatumumab until the last Follow-up Period visit (up to Week 248)|AT Population. Only those participants contributing values at the indicated time point were analyzed.||Months||Full Range|Median
757777|NCT00611455|Secondary|Number of Participants With Immunoglobulin Values Outside the Reference Range During the Follow-up Period|The reference ranges for immunoglobulins (LLN, ULN) are defined as: IgA (grams/Liter): 0.81, 4.63; IgG (grams/Liter): 6.94, 16.18; IgM (grams/Liter): 0.48, 2.71.|From the last scheduled visit in the DB or OL Period until B-cells and circulating IgG had returned to normal or baseline levels (or maximum of 2 years from LSLV)|AT Population. Only those participants contributing values at the indicated time point were analyzed.||Participants|||Number
757778|NCT00611455|Secondary|Number of Participants With Any Serious Adverse Event During the Follow-up Period|A serious adverse event is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; or is a congenital anomaly/birth defect. Medical or scientific judgment should have been exercised in other situations. Refer to the general SAE module for a list of SAEs.|From the last scheduled visit in the DB or OL Period until B-cells and circulating IgG had returned to normal or baseline levels (or maximum of 2 years from Last Subject Last Visit [LSLV])|Safety Follow-up Population: all participants who withdrew from the Double-blind Period and had evidence of contact with the site after the end of the Double-blind Period and all participants who withdrew or completed the Open-label Period and had evidence of contact with the site after their end of Open-label date.||Participants|||Number
757787|NCT00611455|Secondary|Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course|The number of participants with a CD19+ cell count greater than or equal to the lower limit of normal (LLN; reference range 0.11 to 0.66 giga [10^9] per liter) or the baseline value (whichever was lower) is presented. The baseline assessment is defined as the start of the Double-blind Period.|From baseline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.||Participants|||Number
757842|NCT00611559|Secondary|Number of Subjects With Anti-diphtheria and Anti-tetanus Antibodies Concentration Above the Cut-off Before the Booster Dose|Anti-diphtheria and anti-tetanus antibodies cut-off value assessed was ≥ 0.1 IU/mL|Before the booster dose administration (at baseline)|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results||subjects|||Number
757779|NCT00611455|Secondary|Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)|Only those parameters for a particular flag (<LLN or >ULN) are summarized if at least one value was outside the specified reference range. The Baseline (BL) value for a TC was defined as the latest value on or before the date of infusion A of the TC. However to be evaluable as a baseline value, assessments must have been conducted within a 14 day window prior to the date of infusion A. The post-baseline (PBL) was any visit after the date of infusion A during the specified TC. The pre-defined LLN for biomarkers are: B-lymphocyte stimulator (B-ls):<486.5 nanograms per Liter (ng/L); Interleukin-6 (IL-6):<0.31ng/L and Serum amyloid A: <1951 ng/mL. LLN was not defined for Rheumatoid factor (RF)-IgA, RF-IgG, RF-IgM or anti- cyclic citrullinated peptide (CCP) antibody and RF. The pre- defined ULN range for biomarkers (RF)-IgA: >6 units; RF-IgG:>6 units; RF-IgM:>6 units; Anti-CCP:>19.9999 units; B-ls:>1343.3 ng/L; IL-6: >5 ng/L; RF:>11.9999 kilounits (KU)/L; Serum amyloid A:>82432 ng/mL.|From baseline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.||Participants|||Number
757780|NCT00611455|Secondary|Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course|Only those parameters for which at least one value of clinical concern (CC) was reported are summarized. The baseline (BL) value for a treatment course (TC) is defined as the latest value on or before the date of infusion A of the TC. The post-baseline (PBL) visit is defined as any visit after the date of infusion A during the specified TC. Pre-defined limits of potential clinical concern (CC Low [relative to lower limit of normal], CC High [relative to upper limit of normal]) are: Eosinophils: NA, 2; Hematocrit (HCT): 0.75, 1.2; Hemoglobin (Hb): 0.75, 1.2; Lymphocytes: 0.4, 2; Neutrophils total (TNUE): 0.8, 1.6; Platelet count (PC): 0.65, 1.5; Red blood cell count (RBC): 0.75, 2; White blood cell count (WBC): 0.7, 1.6.|From baseline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.||Participants|||Number
757781|NCT00611455|Secondary|Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course|Only those parameters for which at least one value of clinical concern (CC) was reported are summarized. Baseline (BL) value for a treatment course (TC) is defined as the latest value on or before the date of infusion A of the TC. The post-baseline (PBL) visit is defined as any visit after the date of infusion A during the specified TC. Pre-defined limits of potential CC (CC Low [relative to the lower limit of normal], CC High [relative to the upper limit of normal]) are: Albumin: 0.9, 1.5; Alanine amino transferase (ALT): NA, 2; Alkaline phosphatase (ALP): NA, 1.5; Aspartate amino transferase (AST): NA, 2; Bilirubin total (TBIL): NA, 1.5; Calcium: 0.85, 1.08; CO2 content/bicarbonate (BCO): 0.85/0.75, 1.2/1.3, ; Chloride: 0.9, 1.1; Creatine kinase (CK): NA, 2; Creatinine: NA, 1.2; Gamma glutamyl transferase (GGT): NA, 2; Lactate dehydrogenase (LDH): NA, 2; Potassium: 0.9, 1.1; Sodium: 0.93, 1.07; Total protein: 0.8, 1.15; Urea/blood urea nitrogen (BUN): NA, 1.5; Uric acid: NA, 1.5.|From baseline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.||Participants|||Number
757782|NCT00611455|Secondary|Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period|The number of participants with normal, abnormal clinically significant (CS), and abnormal not clinically significant (NCS) ECG findings, as well as the number of participants with no results (NR), during the OL Period are presented. An overall interpretation of the ECG was made by the investigator, or the investigator could delegate this task to a cardiologist, if applicable.|From DB Period completion (Week 24) until the completion of the OL Period, assessed up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.||Participants|||Number
757783|NCT00611455|Secondary|Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course|The baseline value for a treatment course is defined as the value before infusion A of each treatment course. The post-baseline visit is defined as any assessment during or after the start of infusion A during the specified treatment course. Pre-defined limits of potential clinical concern for vital signs (Low, High) are: Diastolic blood pressure (DBP) (millimeters of mercury [mmHg]): 40, 110; Systolic blood pressure (SBP) (mmHg): 90, 170; Heart rate (beats per minute): 35, 120. LLN=lower limit of normal; ULN=upper limit of normal.|From baseline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.||Participants|||Number
757784|NCT00611455|Secondary|Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course|The number of participants with a CD8+ cell count greater than or equal to the lower limit of normal (LLN; reference range 0.11 to 0.66 giga [10^9] per liter) or the baseline value (whichever was lower) is presented. The baseline assessment is defined as the start of the Double-blind Period.|From baseline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.||Participants|||Number
757785|NCT00611455|Secondary|Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course|The number of participants with a CD4+ cell count greater than or equal to the lower limit of normal (LLN; reference range 0.11 to 0.66 giga [10^9] per liter) or the baseline value (whichever was lower) is presented. The baseline assessment is defined as the start of the Double-blind Period.|From baseline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.||Participants|||Number
757786|NCT00611455|Secondary|Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course|The number of participants with a CD3+ cell count greater than or equal to the lower limit of normal (LLN; reference range 0.11 to 0.66 giga [10^9] per liter) or the baseline value (whichever was lower) is presented. The baseline assessment is defined as the start of the Double-blind Period.|From baseline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.||Participants|||Number
758548|NCT00617890|Secondary|Overall Survival|This is a measure of the number of participants known to be alive at the time of data analysis for this study.|From start of treatment until death or data analysis cut off (Up to 3.4 years)|All study participants||Participants|||Number
757788|NCT00611455|Secondary|Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event, During the DB and OL Periods, by Ofatumumab Treatment Course|An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; or is a congenital anomaly/birth defect. Medical or scientific judgment should have been exercised in other situations. Refer to the general AE/SAE module for a list of AEs (occurring at a frequency threshold >=2%) and SAEs.|First treatment (Day 0) until the participant terminated the trial, assessed up to Week 144|AT Population||Participants|||Number
757789|NCT00611455|Secondary|Time to Retreatment, by Ofatumumab Treatment Course|Time to retreatment is defined as the time in days between infusion A of each treatment course and infusion A of the following treatment course. For participants randomized to ofatumumab in the Double-blind Period, Treatment Course 1 refers to the course of ofatumumab received in the Double-blind Period. The minimum period allowed per protocol before retreatment was 24 weeks (end of Double-blind Period). For participants randomized to placebo in the Double-blind Period, Treatment Course 1 refers to the first course of ofatumumab received in the Open-label Period. The minimum period allowed per protocol before retreatment during the Open-label Period was 16 weeks.|From Baseline up to Week 144|AT Population. Only those participants who were retreated from Week 24 were analyzed.||Weeks||Standard Deviation|Mean
757790|NCT00611455|Secondary|Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using CRP), During the DB and OL Periods, by Ofatumumab Treatment Course|The DAS28 is a clinical index of rheumatoid arthritis disease activity that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of disease activity can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. Remission is defined as a DAS28 score <2.6 at any time during the first 24 weeks of each treatment course. Low disease activity is defined as a DAS28 score >=2.6 and <3.2 at any time during the first 24 weeks of each treatment course.|First 24 weeks of each treatment course (assessed up to Week 144)|AT Population||participants|||Number
757791|NCT00611455|Secondary|Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using ESR), During the DB and OL Periods, by Ofatumumab Treatment Course|The DAS28 is a clinical index of rheumatoid arthritis disease activity that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of disease activity can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. Remission is defined as a DAS28 score <2.6 at any time during the first 24 weeks of each treatment course. Low disease activity is defined as a DAS28 score >=2.6 and <3.2 at any time during the first 24 weeks of each treatment course.|First 24 weeks of each treatment course (assessed up to Week 144)|AT Population||participants|||Number
757792|NCT00611455|Secondary|Minimum Change From Baseline in the DAS28-CRP Score, During the DB and OL Periods, by Ofatumumab Treatment Course|The level of rheumatoid arthritis disease activity based on the DAS28 score is defined as low if DAS28 <=3.2, moderate if 3.2< DAS28 <=5.1, or high if DAS28 > 5.1. A DAS28 <2.6 corresponds to clinical remission. The values summarized are the minimum change from baseline DAS28 score (i.e. greatest change in disease activity during the treatment course) achieved by each participant within the first 24 weeks of each treatment course, assessed by using CRP. Baseline score was determined at the start of each treatment course. For change from baseline, participants had to have both a baseline DAS28 value for the treatment course (i.e., the latest value on or before the date of infusion A of the treatment course, providing it was done within a 14 day window prior to the date of infusion A) and a DAS28 value during the treatment course (i.e., during first 24 weeks of each treatment course). Change from baseline was calculated as the value during the treatment course minus the baseline value.|First 24 weeks of each treatment course (assessed up to Week 144)|AT Population. Only those participants contributing values at the indicated time point were analyzed.||scores on a scale||Standard Deviation|Mean
757793|NCT00611455|Secondary|Minimum Change From Baseline in the DAS28-ESR Score, During the DB and OL Periods, by Ofatumumab Treatment Course|The level of rheumatoid arthritis disease activity based on the DAS28 score is defined as low if DAS28 <=3.2, moderate if 3.2< DAS28 <=5.1, or high if DAS28 > 5.1. A DAS28 <2.6 corresponds to clinical remission. The values summarized are the minimum change from baseline DAS28 score (i.e. greatest change in disease activity during the treatment course) achieved by each participant within the first 24 weeks of each treatment course, assessed by using ESR. Baseline score was determined at the start of each treatment course. For change from baseline, participants had to have both a baseline DAS28 value for the treatment course (i.e., the latest value on or before the date of infusion A of the treatment course, providing it was done within a 14 day window prior to the date of infusion A) and a DAS28 value during the treatment course (i.e., during first 24 weeks of each treatment course). Change from baseline was calculated as the value during the treatment course minus the baseline value.|First 24 weeks of each treatment course (assessed up to Week 144)|AT Population. Only those participants contributing values at the indicated time point were analyzed.||scores on a scale||Standard Deviation|Mean
757794|NCT00611455|Secondary|Minimum DAS28-CRP Score During the DB and OL Periods, by Ofatumumab Treatment Course|The DAS28 is a clinical index of rheumatoid arthritis disease activity that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of disease activity can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. The values summarized are the minimum DAS28 score (i.e. lowest level of disease activity) achieved by each participant within the first 24 weeks of each treatment course, assessed using C-reactive Protein (CRP: used to monitor acute inflammatory phases of rheumatoid arthritis).|First 24 weeks of each treatment course (assessed up to Week 144)|AT Population. Only those participants contributing values at the indicated time point were analyzed.||scores on a scale||Standard Deviation|Mean
757795|NCT00611455|Secondary|Minimum DAS28-ESR Score During the Double-blind (DB) and Open-label (OL) Periods, by Ofatumumab Treatment Course|The DAS28 is a clinical index of rheumatoid arthritis disease activity that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of disease activity can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. The values summarized are the minimum DAS28 score (i.e. lowest level of disease activity) achieved by each participant within the first 24 weeks of each treatment course (TC), assessed using erythrocyte sedimentation rate (ESR; rate at which red blood cells sediment in 1 hour).|First 24 weeks of each treatment course (assessed up to Week 144)|As Treated (AT) Population: all participants who received at least one infusion of ofatumumab in the DB and/or OL Period. Only those participants contributing values at the indicated time point were analyzed.||Scores on a scale||Standard Deviation|Mean
757796|NCT00611455|Secondary|Change From Baseline in Levels of IL-6 and Serum Amyloid A at Week 24|The following biomarkers were assessed: Interleukin 6 (IL-6) and Serum Amyloid A. These biomarkers were used to further characterize disease activity.|Baseline and Week 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.||nanogram per liter (ng/l)||Full Range|Median
757797|NCT00611455|Secondary|Change From Baseline in Levels of Anti-CCP, RF-IgA, RF-IgG, and RF-IgM at Week 24|The following biomarkers were assessed: Anti-Cyclic Citrullinated Peptide 3 antibody (Anti-CCP), Rheumatoid factor IgA (RF-IgA), RF IgG (RF-IgG), and RF IgM (RF-IgM). Measurements of RF were used to characterize participants' disease activity and immune status. Anti-CCP was used to characterize the disease type and the immune status of the participants. Assessments for which results were below the lower limit of quantification (LLQ) were reported using a value of LLQ/2. Assessments for which results were above the upper limit of quantification (ULQ) were reported using a value of ULQ.|Baseline and Week 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.||Units/Liter||Full Range|Median
757798|NCT00611455|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT) Questionnaire Score at Week 24|"The FACIT-F score has a valid range of values from 0 to 52, with a higher score indicating a lower burden of fatigue. The subset determining fatigue contains 13 questions. Responses to each question were scored from 0, indicating Not at all fatigued, to 4, indicating Very much fatigued."|Baseline and Week 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.||scores on a scale||Full Range|Median
757799|NCT00611455|Secondary|Change From Baseline in the SF-36v2 Norm-based Scores for Mental Component Summary and Mental Items at Week 24|The SF-36v2 is a standardized questionnaire used to measure overall subjective health status by measuring 8 health-related parameters (each scored from 0 [poorer health] to 100 [better health]): body pain, general mental health (MH), perception of general health, physical functioning, role limitations (RL) caused by mental condition, RL caused by a physical condition, social functioning, and vitality. It yields an 8-scale profile of functional health and well-being scores, as well as psychometrically based physical and MH summary measures and a preference-based health utility index.|Baseline and Week 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.||scores on a scale||Standard Error|Least Squares Mean
757800|NCT00611455|Secondary|Change From Baseline in the Short-Form 36 (SF-36v2) Norm-based Scores for Physical Component Summary and Physical Items at Week 24|The SF-36v2 is a standardized questionnaire used to measure overall subjective health status by measuring 8 health-related parameters (each scored from 0 [poorer health] to 100 [better health]): body pain, general mental health (MH), perception of general health, physical functioning, role limitations (RL) caused by mental condition, RL caused by a physical condition, social functioning, and vitality. It yields an 8-scale profile of functional health and well-being scores, as well as psychometrically based physical and MH summary measures and a preference-based health utility index.|Baseline and Week 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.||scores on a scale||Standard Error|Least Squares Mean
757801|NCT00611455|Secondary|Change From Baseline in ESR at Week 24|ESR is measured by a blood test that shows the rate at which red blood cells sediment in a period of 1 hour. Blood samples for the determination of ESR were taken at pre-specified visits and were measured immediately at the trial site. Change from baseline in ESR was calculated as the Week 24 value minus the baseline value.|Baseline and Week 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.||millimeters per hour (mm/hr)||Full Range|Median
757802|NCT00611455|Secondary|Change From Baseline in CRP at Week 24|Blood samples for the determination of CRP were taken at pre-specified visits and were sent to the central laboratory for analysis. Change from Baseline in CRP was calculated as the Week 24 value minus the baseline value. CRP is an acute-phase protein whose plasma concentration increases in response to inflammation. CRP is a useful marker of inflammation.|Baseline and Week 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.||milligrams per liter (mg/L)||Full Range|Median
757803|NCT00611455|Secondary|Change From Baseline in HAQ-DI Score at Week 24|The self-assessed HAQ-DI is a 20-question instrument used to assess the degree of difficulty a participant had in accomplishing tasks in 8 functional areas (FAs): dressing, arising, eating, walking, hygiene, reaching, gripping, and errands/chores. Responses for each FA were scored from 0 (no difficulty) to 3 (inability to perform a task). The total score (range of 0-3) was calculated by adding the 8 individual FA scores, then dividing this sum by the total number of components answered. Change from baseline was calculated as the value at Week 24 minus the baseline value.|Baseline and Week 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.||scores on a scale||Full Range|Median
758703|NCT00618514|Secondary|Number of Limbs With a Device-related Non-serious Adverse Event Reported Over 6 Months.|Each treated limb was clinically evaluated for the presence of a device-related non-serious adverse event.|6 Months|||Limbs|Participants||Number
757804|NCT00611455|Secondary|Change From Baseline in the Physician-assessed Global Disease Score at Week 24|"The physician used a horizontal VAS of 100 mm for overall assessment of disease. The scale ranged from 0 (very well) to 100 (very poor). Physicians were instructed to draw a vertical line through the horizontal line to indicate the state of the arthritis. The distance from the very well end to the vertical line drawn by the participant was the global disease assessment score. Change from baseline in the physician-assessed global disease was calculated as the Week 24 value minus the baseline value."|Baseline and Week 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.||scores on a scale||Full Range|Median
757805|NCT00611455|Secondary|Change From Baseline in Participant-assessed Global Disease Score at Week 24|"The participant used a horizontal VAS of 100 mm for overall assessment of disease. The scale ranged from 0 (very well) to 100 (very poor). Participants were instructed to draw a vertical line through the horizontal line to indicate the state of the arthritis. The distance from the very well end to the vertical line drawn by the participant was the global disease assessment score. Change from baseline in participant-assessed global disease was calculated as the Week 24 value minus the baseline value."|Baseline and Week 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.||scores on a scale||Full Range|Median
757806|NCT00611455|Secondary|Change From Baseline in the Participant-assessed Pain Score at Week 24|"A horizontal VAS of 100 mm was used to report the participant’s level of joint pain. The scale ranged from 0 (no pain) to 100 (unbearable pain). Participants were instructed to draw a vertical line through the horizontal line to indicate how much joint pain they had. The distance from the no pain end to the vertical line drawn by the participant was the joint pain score. Change from baseline was calculated as the Week 24 value minus the baseline value."|Baseline and Week 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.||scores on a scale||Full Range|Median
757807|NCT00611455|Secondary|Change From Baseline in Swollen Joint Count at Week 24|Change from baseline in swollen joint count was calculated as the Week 24 count minus the baseline count. A total of 66 joints were assessed. Joints were classified as either swollen or not swollen by an independent assessor, who had documented experience in performing joint assessments.|Baseline and Week 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.||number of swollen joints||Full Range|Median
757808|NCT00611455|Secondary|Change From Baseline in Tender Joint Count at Week 24|Change from baseline in tender joint count was calculated as the Week 24 count minus the baseline count. A total of 68 joints were assessed. Joints were classified as either tender or not tender by an independent assessor, who had documented experience in performing joint assessments.|Baseline and Week 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.||number of tender joints||Full Range|Median
757809|NCT00611455|Secondary|Number of Participants With Clinical Remission at Week 24|Participants achieving clinical remission were defined as those with a low disease activity, i.e., DAS28 score (using CRP) <2.6 at Week 24.|Week 24|ITT Population||participants|||Number
757810|NCT00611455|Secondary|Number of Participants Classified as Responders at Week 24 According to the Self-Assessed Health Assessment Questionnaire Disability Index (HAQ-DI)|The HAQ-DI is a 20-question instrument used to assess the degree of difficulty a participant had in accomplishing tasks in 8 functional areas (FAs): dressing, arising, eating, walking, hygiene, reaching, gripping, and errands/chores. Responses for each FA were scored from 0 (no difficulty) to 3 (inability to perform a task). The total score (range of 0-3) was calculated by adding the 8 individual FA scores, then dividing this sum by the total number of components answered. Responders were defined as participants achieving an improvement from baseline in the HAQ-DI score at Week 24 of >=0.22.|Week 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.||participants|||Number
757811|NCT00611455|Secondary|Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant|The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 <=3.2; moderate responders: change from baseline >1.2 with DAS28 <=3.2 to >5.1 or change from baseline >0.6 to <=1.2 with DAS28 <=3.2 to <=5.1); non-responders: change from baseline <=0.6 or change from baseline >0.6 and <=1.2 with DAS28 >5.1.|Weeks 4, 8, 12, 16, 20, and 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.||participants|||Number
757812|NCT00611455|Secondary|Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant|The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 <=3.2; moderate responders: change from baseline >1.2 with DAS28 <=3.2 to >5.1 or change from baseline >0.6 to <=1.2 with DAS28 <=3.2 to <=5.1); non-responders: change from baseline <=0.6 or change from baseline >0.6 and <=1.2 with DAS28 >5.1.|Weeks 4, 8, 12, 16, 20, and 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.||participants|||Number
757813|NCT00611455|Secondary|Change From Baseline in DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant|The DAS28 is a clinical index of RA disease activity that combines information from swollen joints, tender joints, the acute phase reactant, and general health (patient global assessment). Change from baseline in DAS28 is calculated as the Week 4, 8, 12, 16, 20, and 24 values minus the baseline value.|Baseline and Weeks 4, 8, 12, 16, 20, and 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.||scores on a scale||Standard Deviation|Mean
759875|NCT00628355|Primary|Clinical Response Rate|We analyzed the clinical response rate considering significative reduction of 50% of visual analogue scale or significative subjective improvement.|immediately, 1, 3 months after treatment|||percentage of participants|||Number
757814|NCT00611455|Secondary|Mean DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using Erythrocyte Sedimentation Rate (ESR) as the Acute Phase Reactant|The DAS28 is a clinical index of rheumatoid arthritis disease activity (DA) that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of DA can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. APRs are a class of proteins that are useful markers for inflammation.|Weeks 4, 8, 12, 16, 20, and 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.||scores on a scale||Standard Deviation|Mean
757815|NCT00611455|Secondary|Change From Baseline in DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant|The DAS28 is a clinical index of RA disease activity that combines information from swollen joints, tender joints, the acute phase reactant, and general health (patient global assessment). Change from baseline in DAS28 is calculated as the Week 4, 8, 12, 16, 20, and 24 values minus the baseline value.|Baseline and Weeks 4, 8, 12, 16, 20, and 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.||scores on a scale||Standard Deviation|Mean
757816|NCT00611455|Secondary|Mean Disease Activity Score Based on 28 Joints (DAS28) at Weeks 4, 8, 12, 16, 20, and 24 Using C-reactive Protein (CRP) as the Acute Phase Reactant (APR)|The DAS28 is a clinical index of rheumatoid arthritis disease activity (DA) that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of DA can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. APRs are a class of proteins that are useful markers for inflammation.|Weeks 4, 8, 12, 16, 20, and 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.||scores on a scale||Standard Deviation|Mean
757817|NCT00611455|Secondary|Median ACRn at Weeks 4, 8, 12, 16, 20, and 24|ACRn = the largest integer n for which a participant (par.) met the criteria requiring an improvement of n%. ACRn is a measure characterizing percent (%) improvement from baseline (IFBL). A par. with an ACRn of X had an improvement of >=X% in tender/swollen joints (TJC/SJC), and an improvement of >=X% in 3 of the 5 parameters (patient [pt] pain assessment, pt global assessment [GA], physician GA, pt self-assessed disability, acute phase reactant). ACRn = minimum(TJC % IFBL, SJC % IFBL, composite measure % IFBL). Composite measure % IFBL is the 3rd highest value of % IFBL for the 5 parameters.|Weeks 4, 8, 12, 16, 20, and 24|ITT Population. Missing data were imputed using last observation carried forward (LOCF). Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.||percent change||Full Range|Median
757818|NCT00611455|Secondary|Number of Participants With a 70% Improvement From Baseline in Their ACR Score (ACR70) at Weeks 4, 8, 12, 16, 20, and 24|The ACR score was based on improvement from baseline in tender (TJC) and swollen joint counts (SJC). A participant had achieved ACR70 if he experienced >=70% improvement from baseline in TJC and SJC and a >=70% improvement from baseline in 3 out of 5 of the following assessments: participant pain assessment on a 100 millimeter (mm) visual analog scale (VAS), participant global assessment on a 100 mm VAS scale, physician global assessment on a 100 mm VAS scale, participant self-assessed disability, and C-reactive protein.|Baseline and Weeks 4, 8, 12, 16, 20, and 24|ITT Population||participants|||Number
757819|NCT00611455|Secondary|Number of Participants With a 50% Improvement From Baseline in Their ACR Score (ACR50) at Weeks 4, 8, 12, 16, 20, and 24|The ACR score was based on improvement from baseline in tender (TJC) and swollen joint counts (SJC). A participant had achieved ACR50 if he experienced >=50% improvement from baseline in TJC and SJC and a >=50% improvement from baseline in 3 out of 5 of the following assessments: participant pain assessment on a 100 millimeter (mm) visual analog scale (VAS), participant global assessment on a 100 mm VAS scale, physician global assessment on a 100 mm VAS scale, participant self-assessed disability, and C-reactive protein.|Baseline and Weeks 4, 8, 12, 16, 20, and 24|ITT Population||participants|||Number
757820|NCT00611455|Secondary|Number of Participants With a 20% Improvement From Baseline in Their American College of Rheumatology (ACR) Score (ACR20) at Weeks 4, 8, 12, 16, and 20|The ACR score was based on improvement from baseline in tender (TJC) and swollen joint counts (SJC). A participant had achieved ACR20 if he experienced >=20% improvement from baseline in TJC and SJC and a >=20% improvement from baseline in 3 out of 5 of the following assessments: participant pain assessment on a 100 millimeter (mm) visual analog scale (VAS), participant global assessment on a 100 mm VAS scale, physician global assessment on a 100 mm VAS scale, participant self-assessed disability, and C-reactive protein.|Baseline and Weeks 4, 8, 12, 16, and 20|ITT Population||participants|||Number
757821|NCT00611455|Primary|Number of Participants With a 20% Improvement From Baseline in Their American College of Rheumatology (ACR) Score (ACR20) at Week 24|The ACR score was based on improvement from baseline in tender (TJC) and swollen joint counts (SJC). A participant had achieved ACR20 if he experienced >=20% improvement from baseline in TJC and SJC and a >=20% improvement from baseline in 3 out of 5 of the following assessments: participant pain assessment on a 100 millimeter (mm) visual analog scale (VAS), participant global assessment on a 100 mm VAS scale, physician global assessment on a 100 mm VAS scale, participant self-assessed disability, and C-reactive protein.|Baseline and Week 24|Intent-to-Treat (ITT) Population: all randomized participants who were exposed to investigational product irrespective of their compliance to the planned course of treatment. Participants were analyzed according to their randomized treatment.||participants|||Number
757822|NCT00611468|Primary|Pharmacokinetic Parameters of Intravenous Topotecan With and Without Erlotinib (Dose-Normalized AUC)||Day 1 Week 1 and Day 1 Week 3|Of the 29 consenting patients, 18 provided information that could be used in the analysis. 1 patient withdrew, 2 had samples that were inevaluable due to lab error, and 8 went off study before receiving topotecan with erlotinib.||ng*h/mL||Standard Deviation|Mean
757841|NCT00611559|Secondary|Anti-diphtheria and Anti-tetanus Antibodies Concentration|Concentration of anti-diphtheria and anti-tetanus antibodies given as GMC in IU/mL|Before (Pre) and one month after (Post) the booster dose|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results||IU/mL||95% Confidence Interval|Geometric Mean
757823|NCT00611468|Primary|Pharmacokinetic Parameters of Intravenous Topotecan With and Without Erlotinib (Renal Clearance)||Day 1 Week 1 and Day 1 Week 3|Of the 29 consenting patients, 18 provided information that could be used in the analysis. However, only 13 were able to be analyzed for the renal clearance because in 5 patients the amount of topotecan measured in the urine was more than the topotecan dose that was given. Renal clearance was not calculated for those patients.||L/h/m^2||Standard Deviation|Mean
757824|NCT00611468|Primary|Pharmacokinetic Parameters of Intravenous Topotecan With and Without Erlotinib (Mean Clearance)||Day 1 Week 1 and Day 1 Week 3|Of the 29 consenting patients, 18 provided information that could be used in the analysis. 1 patient withdrew, 2 had samples that were inevaluable due to lab error, and 8 went off study before receiving topotecan with erlotinib.||L/h/m^2||Standard Deviation|Mean
757825|NCT00611468|Primary|Dosage Limiting Toxicities||DLT were assessed during the first cycle of combination topotecan and erlotinib therapy (days 1-21)|DLT were assessed using NCI CTCAE version 3.0. After MTD was determined, 13 additional patients were enrolled to enhance estimation of PK parameters. The first 8 were enrolled at dose 2. Because 4 of these patients experienced a DLT, the remaining 5 patients were enrolled at dose level 1. Of these, 1 experienced a DLT.||Participants|||Number
757826|NCT00611468|Secondary|Objective Response (as Determined Using RECIST 1.0 Criteria)||Every 6 weeks until the end of study treatment|After the determination of MTD, an additional 13 patients were enrolled to enhance estimation of PK parameters. The first 8 patients were enrolled at dose level 2, 4 of whom experienced a DLT. Thus, the remaining 5 patients were enrolled at dose 1. One of these patients experienced a DLT.||Participants|||Number
757827|NCT00611468|Secondary|Pharmacogenetic Analysis (CYP3A4/5 Polymorphisms, UGT1A1, BCRP, and MDR1 Genotypes)|Each subgroup lists the gene on which a polymorphism occurred (e.g., CYP3A4), the name of the polymorphism (e.g., *1), whether it was heterozygous or a variant, the number of subjects with available data, and the number who had the polymorphism.|Baseline|Pharmacokinetic studies were done for all 29 consenting patients (one of whom later withdrew).||Participants|||Number
757828|NCT00611468|Primary|Maximum Tolerated Dosage (MTD) of Intravenous Topotecan When Given in Combination With Oral Erlotinib|The MTD of topotecan was determined using a standard 3 + 3 dose escalation cohort design. The total sample and the number of patients who receive each dose in this design depends on the frequency of dose limiting toxicities (DLT) at each dosage. If 0 out of 3 patients experience a DLT at a given dosage level, 3 patients will be enrolled at the next dosage level. If greater than or equal to 2 patients experience a DLT at a given dosage level, dosage escalation will be stopped. If 1 out of 3 patients experience a DLT at a given dosage level, 3 patients are enrolled at the same dosage level.|MTD was assessed during the first cycle of combination topotecan and erlotinib therapy (days 1-21).|DLT information was available for 3 patients who received a topotecan dose of 0.75 mg/M^2, for 6 patients who received a topotecan dose of 1.0 mg/M^2, and for 6 patients who recived a topotecan dose of 1.25 mg/M^2. 1 additional patient received a dose 1.0 mg/M^2 but withdrew before completing cycle 1. This patient had no DLT and was replaced.||mg/m^2|||Number
757829|NCT00611533|Secondary|Weight||Baseline and after 6 weeks intervention|Participants who had at least one post randomization visit.||lb||Standard Deviation|Mean
757830|NCT00611533|Secondary|Heart Rate||Baseline and after 6 weeks intervention|Participants who had at least one post randomization visit.||beats/min||Standard Deviation|Mean
757831|NCT00611533|Secondary|Blood Pressure||Baseline and after 6 weeks intervention|Participants who had least one post randomization visit.||mm Hg||Standard Deviation|Mean
757832|NCT00611533|Primary|BADDS Total Score|The total BADDS ranged from 0-120 with higher scores meaning greater problems with memory, attention and focus.|Baseline and after 6 weeks intervention|Participants who had at least one post randomization visit.||units on a scale||Standard Deviation|Mean
757833|NCT00611533|Primary|Brown Attention Deficit Disorder Scale|Raw scores for 5 clusters (organizing/activating, attention/concentration, alertness/effort/processing, managing affect interference, and working memory/recall) on the BADDS were converted to T scores which range from 50-99, with higher scores meaning greater impairment.|Baseline and after 6 weeks intervention|Participants who completed both interventions.||T score||Standard Deviation|Mean
757834|NCT00611559|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above|Up to one month after the booster dose administration|||subjects|||Number
757835|NCT00611559|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Within the 31-day (Day 0-30) post-vaccination period|||subjects|||Number
757836|NCT00611559|Secondary|Number of Subjects Reporting Solicited Symptoms|Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include drowsiness, fever, irritability, and loss of appetite|Within the 4-day (Day 0-3) post-vaccination period|||subjects|||Number
757837|NCT00611559|Secondary|Anti-poliovirus Antibodies Titer|Concentration of anti-poliovirus antibodies given as geometric mean titers (GMT)|Before (Pre) and one month after (Post) the booster dose|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results||titer||95% Confidence Interval|Geometric Mean
757838|NCT00611559|Secondary|Number of Subjects With Anti-poliovirus Antibodies Concentration Above the Cut-off Before the Booster Dose|Anti-poliovirus antibodies cut-off value assessed was ≥ 8 ED50|Before the booster dose|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results||subjects|||Number
757839|NCT00611559|Secondary|Anti-PT, Anti-FHA, and Anti-PRN Antibodies Concentration Before the Booster Dose|Concentration of anti-PT, anti-FHA and anti-PRN antibodies given as GMC in EL.U/mL|Before the booster dose administration (at baseline)|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results||EL.U/mL||95% Confidence Interval|Geometric Mean
757840|NCT00611559|Secondary|Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentration Above the Cut-off Before and One Month After the Booster Dose|Anti-PT, anti-FHA and anti-PRN antibodies cut-off value assessed were ≥ 5 EL.U/mL|Before (Pre) and one month after (Post) the booster dose|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results||subjects|||Number
757843|NCT00611559|Secondary|Anti-PRP Antibodies Concentration|Concentration of anti-PRP antibodies given as GMC in µg/mL|Before (Pre) and one month after (Post) the booster dose|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results||µg/mL||95% Confidence Interval|Geometric Mean
757844|NCT00611559|Secondary|Number of Subjects With Anti-PRP Antibodies Concentrations Above the Cut-off Before and One Month After the Booster Dose|"Anti-PRP antibodies cut-off value assessed were ≥ 0.15 µg/mL and ≥ 1.0 µg/mL
Number of subjects with cut-off ≥ 0.15 µg/mL one month after the booster dose was already presented in the primary outcomes"|Before (Pre) and one month after (Post) the booster dose|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results||subjects|||Number
757845|NCT00611559|Secondary|Anti-HB Antibodies Concentration|Concentration of anti-HB antibodies given as GMC in mIU/mL|Before (Pre) and one month after (Post) the booster dose|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results||mIU/mL||95% Confidence Interval|Geometric Mean
757846|NCT00611559|Secondary|Number of Subjects With Anti-hepatitis B (HB) Antibody Concentrations Above the Cut-off Before and One Month After the Booster Dose|"Anti-HB antibodies cut-off value assessed were ≥ 10 mIU/mL and ≥ 100 mIU/mL
Number of subjects with cut-off ≥ 10 mIU/mL one month after the booster dose was already presented in the primary outcomes"|Before (Pre) and one month after (Post) the booster dose|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results||subjects|||Number
757847|NCT00611559|Primary|Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibodies Concentration One Month After the Booster Dose|Concentration of anti-PT, ant-FHA and anti-PRN antibodies given as geometric mean concentration (GMC) in Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per millilitre (EL.U/mL)|One month after the booster dose|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results||EL.U/mL||95% Confidence Interval|Geometric Mean
757848|NCT00611559|Primary|Number of Subjects With Anti-poliovirus Antibodies Concentration Above the Cut-off One Month After the Booster Dose|Anti-poliovirus antibodies cut-off value assessed was ≥ 8 effective dose 50 (ED50)|One month after the booster dose|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results||subjects|||Number
757849|NCT00611559|Primary|Number of Subjects With Anti-diphtheria and Anti-tetanus Antibodies Concentration Above the Cut-off One Month After the Booster Dose|Anti-diphtheria and anti-tetanus antibodies cut-off value assessed was ≥ 0.1 international units per milliliter (IU/mL)|One month after the booster dose|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results||subjects|||Number
757850|NCT00611559|Primary|Number of Subjects With Anti-polyribosyl-ribitol-phosphate (PRP) Antibodies Concentrations Above the Cut-off One Month After the Booster Dose|Anti-PRP antibodies cut-off value assessed was ≥ 0.15 microgram per milliliter (µg/mL)|One month after the booster dose|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results||subjects|||Number
757851|NCT00611559|Primary|Number of Subjects With Anti-hepatitis B (HB) Antibody Concentrations Above the Cut-off One Month After the Booster Dose|Anti-HB antibodies cut-off value assessed was ≥ 10 milli-international units per milliliter (mIU/mL)|One month after the booster dose|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available results||subjects|||Number
757852|NCT00611624|Secondary|Information of Treatment Parameters in Order to Define Parameters Most Predictive of Skin Toxicity|These data were not collected and were not summarized in this study. Results are not available.|Upon completion of study||||||
757853|NCT00611624|Primary|Skin Toxicity the First Year Following Treatment With the Multiple Dwell Mammosite Delivery Method.|Evaluation of skin toxicity the first year following treatment with the multiple dwell Mammosite delivery method. The number of participants with a grade 2 skin toxicity (or higher) at 1 year follow up are reported. Radiation Therapy Oncology Group (RTOG) and the European organization for research and treatment of cancer (EORTC) Late Radiation Morbidity Scoring Schema were used to assess toxicity.|one year|26 participants completed the 1 year assessment.||Participants|||Count of Participants
757854|NCT00611715|Secondary|Number of Patients With Worst-grade Toxicities Per Grade|Number of patients with worst-grade toxicities following NCI Common Toxicity Criteria: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, disabling, 5 = death|at 24 weeks|All patients who received treatment and experienced an adverse event.||participants|||Number
757855|NCT00611715|Secondary|Number of Patients With Anti-tumor Activity: Complete Response (CR) and Partial Response (PR)|Per RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions and partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions.|at 24 weeks|Analysis population is patients who were available for response measurement. Seven patients in the Hormone therapy naive arm did not meet the criteria for response evaluation. One patient in the Previous Hormone Therapy arm did not meet the criteria for response evaluation.||participants|||Number
757856|NCT00611715|Secondary|Median Time to Progression of Target Lesions|Time frame from study entry till discontinuation of treatment due to disease progression. Progression of target lesions is measured by RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) > 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions.|Every 12 weeks from on-study to disease progression|Patients who were available for response measurement. Seven patients in the Hormone therapy naive arm did not meet the criteria for response evaluation. One patient in the Previous Hormone Therapy arm did not meet the criteria for response evaluation.||Months||Full Range|Median
757857|NCT00611715|Primary|Number of Patients With Pathological Complete Response.|Per RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions|at 24 weeks|Analysis population is patients who were available for response measurement. Some patients did not meet the criteria to be analyzed for response evaluation which accounts for the discrepancy in patients analyzed vs. total accrual population.||participants|||Number
757858|NCT00611767|Secondary|Verbal Fluency|"Verbal Fluency Task: requires subjects to generate as many words as possible beginning with a single letter (e.g., H) during a one-minute interval. (total words in one-minute interval)"|15 minutes|All available data was utilized in the analysis using mixed models.||number of words||Standard Deviation|Mean
757859|NCT00611767|Secondary|Hopkins Verbal Learning Task (HVLT) - Delayed Recall|Hopkins Verbal Learning Task (HVLT) - measures verbal memory and hippocampus function with word recall at 30 minutes) (0 no words recalled - 12 all words recalled)|45 minutes|All available data was utilized in the analysis using mixed models.||words recalled||Standard Deviation|Mean
757860|NCT00611767|Secondary|Hopkins Verbal Learning Task (HVLT) - Total Recall|Hopkins Verbal Learning Task (HVLT) - measures verbal memory and hippocampus function based on word recall. (0 = no words recalled - 36 = all words recalled)|15 minutes|All available data was utilized in the analysis using mixed models.||words recalled||Standard Deviation|Mean
757861|NCT00611767|Secondary|Pegboard Task - 15 Minutes (Non-Dominant Hand)|The pegboard task is a measure of coordination that measures reaction time; how long a subject takes to insert pegs into a pegboard puzzle, first using their dominant hand then using their non-dominant hand. A quicker time indicates greater coordination. Scores are timed in seconds.|15 minutes|All available data was utilized in the analysis using mixed models.||seconds||Standard Deviation|Mean
757862|NCT00611767|Secondary|Pegboard Task - Baseline (Non-Dominant Hand)|The pegboard task is a measure of coordination that measures reaction time; how long a subject takes to insert pegs into a pegboard puzzle, first using their dominant hand then using their non-dominant hand. A quicker time indicates greater coordination. Scores are timed in seconds.|Baseline|All available data was utilized in the analysis using mixed models.||seconds||Standard Deviation|Mean
757863|NCT00611767|Secondary|Pegboard Task - 15 Minutes (Dominant Hand)|The pegboard task is a measure of coordination that measures reaction time; how long a subject takes to insert pegs into a pegboard puzzle, first using their dominant hand then using their non-dominant hand. A quicker time indicates greater coordination. Scores are timed in seconds|15 minutes|All available data was utilized in the analysis using mixed models.||seconds||Standard Deviation|Mean
757864|NCT00611767|Secondary|Pegboard Task - Baseline (Dominant Hand)|The pegboard task is a measure of coordination that measures reaction time; how long a subject takes to insert pegs into a pegboard puzzle, first using their dominant hand then using their non-dominant hand. A quicker time indicates greater coordination. Scores are timed in seconds|Baseline|All available data was utilized in the analysis using mixed models.||seconds||Standard Deviation|Mean
757865|NCT00611767|Secondary|Clinician Administered Dissociative Symptoms Scale - Clinician Rated - 110 Minutes|Clinician Administered Dissociative Symptoms Scale (CADSS) is a patient and Clinician rated measurement of dissociative states induced by thiopental (0 not at all dissociative - 20 extreme dissociative)|110 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
757866|NCT00611767|Secondary|Clinician Administered Dissociative Symptoms Scale - Clinician Rated - 80 Minutes|Clinician Administered Dissociative Symptoms Scale (CADSS) is a patient and Clinician rated measurement of dissociative states induced by thiopental (0 not at all dissociative - 20 extreme dissociative)|80 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
757867|NCT00611767|Secondary|Clinician Administered Dissociative Symptoms Scale - Clinician Rated - 15 Minutes|Clinician Administered Dissociative Symptoms Scale (CADSS) is a patient and Clinician rated measurement of dissociative states induced by thiopental (0 not at all dissociative - 20 extreme dissociative)|15 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
757868|NCT00611767|Secondary|Clinician Administered Dissociative Symptoms Scale - Clinician Rated - Baseline|Clinician Administered Dissociative Symptoms Scale (CADSS) is a patient and Clinician rated measurement of dissociative states induced by thiopental (0 not at all dissociative - 20 extreme dissociative)|Baseline|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
757869|NCT00611767|Secondary|Clinician Administered Dissociative Symptoms Scale - Patient Rated - 110 Minutes|Clinician Administered Dissociative Symptoms Scale (CADSS) is a patient and Clinician rated measurement of dissociative states induced by thiopental (0 not at all dissociative - 84 extreme dissociative)|110 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
757870|NCT00611767|Secondary|Clinician Administered Dissociative Symptoms Scale - Patient Rated - 80 Minutes|Clinician Administered Dissociative Symptoms Scale (CADSS) is a patient and Clinician rated measurement of dissociative states induced by thiopental (0 not at all dissociative - 84 extreme dissociative)|80 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
757871|NCT00611767|Secondary|Clinician Administered Dissociative Symptoms Scale - Patient Rated - 15 Minutes|Clinician Administered Dissociative Symptoms Scale (CADSS) is a patient and Clinician rated measurement of dissociative states induced by thiopental (0 not at all dissociative - 84 extreme dissociative)|15 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
757872|NCT00611767|Secondary|Clinician Administered Dissociative Symptoms Scale - Patient Rated - Baseline|Clinician Administered Dissociative Symptoms Scale (CADSS) is a patient and Clinician rated measurement of dissociative states induced by thiopental (0 not at all dissociative - 84 extreme dissociative)|Baseline|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
757873|NCT00611767|Secondary|Visual Analog Scales (VAS) - Anxious - 230 Minutes|visual analog scale (VAS): self-report scale used to measure anxiety (0 not at all anxious - 7 extremely anxious)|230 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
757874|NCT00611767|Secondary|Visual Analog Scales (VAS) - Anxious - 170 Minutes|visual analog scale (VAS): self-report scale used to measure anxiety (0 not at all anxious - 7 extremely anxious)|170 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
757875|NCT00611767|Secondary|Visual Analog Scales (VAS) - Anxious - 110 Minutes|visual analog scale (VAS): self-report scale used to measure anxiety (0 not at all anxious - 7 extremely anxious)|110 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
757877|NCT00611767|Secondary|Visual Analog Scales (VAS) - Anxious - 45 Minutes|visual analog scale (VAS): self-report scale used to measure anxiety (0 not at all anxious - 7 extremely anxious)|45 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
757878|NCT00611767|Secondary|Visual Analog Scales (VAS) - Anxious - 15 Minutes|visual analog scale (VAS): self-report scale used to measure anxiety (0 not at all anxious - 7 extremely anxious)|15 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
757879|NCT00611767|Secondary|Visual Analog Scales (VAS) - Anxious - Baseline|visual analog scale (VAS): self-report scale used to measure anxiety (0 not at all anxious - 7 extremely anxious)|Baseline|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
757880|NCT00611767|Secondary|Visual Analog Scales (VAS) - Depressed - 230 Minutes|visual analog scale (VAS): self-report scale used to measure depressed (0 not at all depressed - 7 extremely depressed)|230 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
757881|NCT00611767|Secondary|Visual Analog Scales (VAS) - Depressed - 170 Minutes|visual analog scale (VAS): self-report scale used to measure depressed (0 not at all depressed - 7 extremely depressed)|170 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
757882|NCT00611767|Secondary|Visual Analog Scales (VAS) - Depressed - 110 Minutes|visual analog scale (VAS): self-report scale used to measure depressed (0 not at all depressed - 7 extremely depressed)|110 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
757883|NCT00611767|Secondary|Visual Analog Scales (VAS) - Depressed - 80 Minutes|visual analog scale (VAS): self-report scale used to measure depressed (0 not at all depressed - 7 extremely depressed)|80 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
757884|NCT00611767|Secondary|Visual Analog Scales (VAS) - Depressed - 45 Minutes|visual analog scale (VAS): self-report scale used to measure depressed (0 not at all depressed - 7 extremely depressed)|45 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
757885|NCT00611767|Secondary|Visual Analog Scales (VAS) - Depressed - 15 Minutes|visual analog scale (VAS): self-report scale used to measure depressed (0 not at all depressed - 7 extremely depressed)|15 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
757886|NCT00611767|Secondary|Visual Analog Scales (VAS) - Depressed - Baseline|visual analog scale (VAS): self-report scale used to measure depressed (0 not at all depressed - 7 extremely depressed)|Baseline|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
757887|NCT00611767|Secondary|Visual Analog Scales (VAS) - Drowsy - 230 Minutes|visual analog scale (VAS): self-report scale used to measure drowsy (0 not at all drowsy - 7 extremely drowsy)|230 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
757888|NCT00611767|Secondary|Visual Analog Scales (VAS) - Drowsy - 170 Minutes|visual analog scale (VAS): self-report scale used to measure drowsy (0 not at all drowsy - 7 extremely drowsy)|170 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
757889|NCT00611767|Secondary|Visual Analog Scales (VAS) - Drowsy - 110 Minutes|visual analog scale (VAS): self-report scale used to measure drowsy (0 not at all drowsy - 7 extremely drowsy)|110 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
757890|NCT00611767|Secondary|Visual Analog Scales (VAS) - Drowsy - 80 Minutes|visual analog scale (VAS): self-report scale used to measure drowsy (0 not at all drowsy - 7 extremely drowsy)|80 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
757891|NCT00611767|Secondary|Visual Analog Scales (VAS) - Drowsy - 45 Minutes|visual analog scale (VAS): self-report scale used to measure drowsy (0 not at all drowsy - 7 extremely drowsy)|45 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
757892|NCT00611767|Secondary|Visual Analog Scales (VAS) - Drowsy - 15 Minutes|visual analog scale (VAS): self-report scale used to measure drowsy (0 not at all drowsy - 7 extremely drowsy)|15 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
757893|NCT00611767|Secondary|Visual Analog Scales (VAS) - Drowsy - Baseline|visual analog scale (VAS): self-report scale used to measure drowsy (0 not at all drowsy - 7 extremely drowsy)|Baseline|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
757894|NCT00611767|Secondary|Visual Analog Scales (VAS) - Buzzed - 230 Minutes|visual analog scale (VAS): self-report scale used to measure buzzed (0 not at all buzzed - 7 extremely buzzed)|230 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
757895|NCT00611767|Secondary|Visual Analog Scales (VAS) - Buzzed - 170 Minutes|visual analog scale (VAS): self-report scale used to measure buzzed (0 not at all buzzed - 7 extremely buzzed)|170 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
757896|NCT00611767|Secondary|Visual Analog Scales (VAS) - Buzzed - 110 Minutes|visual analog scale (VAS): self-report scale used to measure buzzed (0 not at all buzzed - 7 extremely buzzed)|110 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
757897|NCT00611767|Secondary|Visual Analog Scales (VAS) - Buzzed - 80 Minutes|visual analog scale (VAS): self-report scale used to measure buzzed (0 not at all buzzed - 7 extremely buzzed)|80 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
757898|NCT00611767|Secondary|Visual Analog Scales (VAS) - Buzzed - 45 Minutes|visual analog scale (VAS): self-report scale used to measure buzzed (0 not at all buzzed - 7 extremely buzzed)|45 minutes|All available data was utilized in the analysis using mixed models||units on a scale||Standard Deviation|Mean
757899|NCT00611767|Secondary|Visual Analog Scales (VAS) - Buzzed - 15 Minutes|visual analog scale (VAS): self-report scale used to measure buzzed (0 not at all buzzed - 7 extremely buzzed)|15 minutes|All available data was utilized in the analysis using mixed models||units on a scale||Standard Deviation|Mean
772066|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 5|Subject Satisfaction - ease of deflation|12 months post-surgery|||% satisfactory or somewhat satisfactory|||Number
757900|NCT00611767|Secondary|Visual Analog Scales (VAS) - Buzzed - Baseline|visual analog scale (VAS): self-report scale used to measure buzzed (0 not at all buzzed - 7 extremely buzzed)|Baseline|All available data was utilized in the analysis using mixed models||units on a scale||Standard Deviation|Mean
757901|NCT00611767|Secondary|Visual Analog Scales (VAS) - High - 230 Minutes|visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)|230 minutes|All available data was utilized in the analysis using mixed models||units on a scale||Standard Deviation|Mean
757902|NCT00611767|Secondary|Visual Analog Scales (VAS) - High - 170 Minutes|visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)|170 minutes|All available data was utilized in the analysis using mixed models||units on a scale||Standard Deviation|Mean
757903|NCT00611767|Secondary|Visual Analog Scales (VAS) - High - 110 Minutes|visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)|110 minutes|All available data was utilized in the analysis using mixed models||units on a scale||Standard Deviation|Mean
757904|NCT00611767|Secondary|Visual Analog Scales (VAS) - High - 80 Minutes|visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)|80 minutes|All available data was utilized in the analysis using mixed models||units on a scale||Standard Deviation|Mean
757905|NCT00611767|Secondary|Visual Analog Scales (VAS) - High - 45 Minutes|visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)|45 minutes|All available data was utilized in the analysis using mixed models||units on a scale||Standard Deviation|Mean
757906|NCT00611767|Secondary|Visual Analog Scales (VAS) - High - 15 Minutes|visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)|15 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
757907|NCT00611767|Secondary|Visual Analog Scales (VAS) - High - Baseline|visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)|Baseline|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
757908|NCT00611767|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 230 Minutes|Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)|230 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
757909|NCT00611767|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 170 Minutes|Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)|170 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
757910|NCT00611767|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 110 Minutes|Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)|110 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
757911|NCT00611767|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 80 Minutes|Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)|80 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
757912|NCT00611767|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 45 Minutes|Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)|45 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
757913|NCT00611767|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 15 Minutes|Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)|15 minutes|All available data was utilized in the analysis using mixed models||units on a scale||Standard Deviation|Mean
757914|NCT00611767|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative Baseline|Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)|Baseline|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
757915|NCT00611767|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 230 Minutes|Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)|230 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
757916|NCT00611767|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 170 Minutes|Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)|170 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
757917|NCT00611767|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant- 110 Minutes|Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)|110 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
757918|NCT00611767|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 80 Minutes|Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)|80 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
757919|NCT00611767|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 45 Minutes|Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)|45 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
757920|NCT00611767|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 15 Minutes|Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)|15 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
757921|NCT00611767|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - Baseline|Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)|Baseline|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
757922|NCT00611767|Secondary|Number of Drinks Felt Consumed - 230 Minutes|The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.|230 minutes|All available data was utilized in the analysis using mixed models.||number of drinks felt consumed||Standard Deviation|Mean
757923|NCT00611767|Secondary|Number of Drinks Felt Consumed - 170 Minutes|The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.|170 minutes|All available data was utilized in the analysis using mixed models.||number of drinks felt consumed||Standard Deviation|Mean
757924|NCT00611767|Secondary|Number of Drinks Felt Consumed - 110 Minutes|The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.|110 minutes|All available data was utilized in the analysis using mixed models.||number of drinks felt consumed||Standard Deviation|Mean
757925|NCT00611767|Secondary|Number of Drinks Felt Consumed - 80 Minutes|The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.|80 minutes|All available data was utilized in the analysis using mixed models.||number of drinks felt consumed||Standard Deviation|Mean
757926|NCT00611767|Secondary|Number of Drinks Felt Consumed - 45 Minutes|The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.|45 minutes|All available data was utilized in the analysis using mixed models.||number of drinks felt consumed||Standard Deviation|Mean
757927|NCT00611767|Secondary|Number of Drinks Felt Consumed - 15 Minutes|The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.|15 minutes|All available data was utilized in the analysis using mixed models.||number of drinks felt consumed||Standard Deviation|Mean
757928|NCT00611767|Secondary|Number of Drinks Felt Consumed at Baseline|The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.|Baseline|All available data was utilized in the analysis using mixed models.||number of drinks felt consumed||Standard Deviation|Mean
757929|NCT00611767|Primary|Visual Analog Scales of Similarity to Alcohol - 230 Minutes|Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|230 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
757930|NCT00611767|Primary|Visual Analog Scales of Similarity to Alcohol - 170 Minutes|Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|170 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
757931|NCT00611767|Primary|Visual Analog Scales of Similarity to Alcohol - 110 Minutes|Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|110 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
757932|NCT00611767|Primary|Visual Analog Scales of Similarity to Alcohol - 80 Minutes|Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|80 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
757933|NCT00611767|Primary|Visual Analog Scales of Similarity to Alcohol - 45 Minutes|Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|45 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
757934|NCT00611767|Primary|Visual Analog Scales of Similarity to Alcohol - 15 Minutes|Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|15 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
757935|NCT00611767|Primary|Visual Analog Scales of Similarity to Alcohol - Baseline|Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|Baseline|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
757936|NCT00611806|Secondary|Relationship Between Response of Negative and Positive Symptoms and the Change in RBC Folate, Serum Folate, Serum B12, and Plasma Homocysteine Concentrations||Measured at Week 16||||||
757937|NCT00611806|Secondary|Positive and Negative Syndrome Scale (PANSS) and FOLH1, MTHRF, MTR, and COMT Genotype|The change from baseline on the Positive and Negative Syndrome Scale (PANSS) (including FOLH1, MTHRF, MTR, and COMT genotype simultaneously into a linear mixed model).The PANNS has three sub-scales: positive (score range 7-49), negative (score range 7-49), and general psychopathology (score range 16-112). The PANSS negative and positive symptom sub-scale is comprised of 7 items rated on a scale of 1-7 representing the negative and positive symptoms of schizophrenia, respectively, and the general psychopathology sub-scale is comprised of 16 items rated on a scale of 1-7 representing symptoms of general psychopathology in mental illness. The total score was computed by adding all the items on the sub-scale together. Scores reported are change in symptoms per week, relative to baseline. A negative score represents a decrease in total PANSS score per week, whereas a positive score represents an increase in total PANSS score per week.|Baseline vs. Week 16|Participants analyzed were those who completed at least 1 post-baseline visit or more (n = 135) and agreed to the DNA blood draw (n = 120).||units on a scale||95% Confidence Interval|Mean
757938|NCT00611806|Secondary|Scale for Assessment of Negative Symptoms (SANS)|The change from baseline on the scale for the assessment of negative symptoms (SANS) total score. Total SANS scores range from 0-100. The SANS is comprised of 5 subscores: Affective Flattening or Blunting (score range 0-35), Alogia (score range 0-20), Avolition-Apathy (score range 0-15), Anhedonia-Asociality (score range 0-20), and Attention (0-10). For each scale, the higher the score the more prominent the negative symptoms were. The total score was computed by adding all the sub-scale total scores. Scores reported are change in symptoms per week, relative to baseline. A negative score represents a decrease in total SANS score per week, whereas a positive score represents an increase in total SANS score per week.|Baseline vs. Week 16|Participants analyzed were those who completed at least 1 post-baseline visit or more (n = 135). 120 participants completed the study to the week 16 endpoint; however, 15 participants did not complete the entire 16 weeks, but completed at least one post-baseline study visit where the SANS assessment was performed.||units on a scale||95% Confidence Interval|Mean
772067|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 5|Subject Satisfaction - ease of deflation|6 months post-surgery|||% satisfactory or somewhat satisfactory|||Number
757939|NCT00611806|Secondary|Positive Sub Scale of the Positive and Negative Syndrome Scale (PANSS)|The change from baseline on the positive symptom sub-scale of the Positive and Negative Syndrome Scale (PANSS). Total PANSS positive symptom sub-scale scores range from 7-49. The PANSS positive symptom sub-scale is comprised of 7 items rated on a scale of 1-7: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. A score of one on each item 1 absent, 2 is minimal, 3 is mild, 4 is moderate, 5 is moderately severe, 6 is severe, and 7 is extreme. The total score was computed by adding all the items on the sub-scale together. Scores reported are change in symptoms per week, relative to baseline. A negative score represents a decrease in total PANSS score per week, whereas a positive score represents an increase in total PANSS score per week.|Baseline vs. Week 16|Participants analyzed were those who completed at least 1 post-baseline visit or more (n = 135). 120 participants completed the study to the week 16 endpoint; however, 15 participants did not complete the entire 16 weeks, but completed at least one post-baseline study visit where the PANSS assessment was performed.||units on a scale||95% Confidence Interval|Mean
757940|NCT00611806|Secondary|Cognitive Deficits, as Measured by the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Cognitive Battery Composite Score||Measured at Week 16||||||
757941|NCT00611806|Primary|Positive and Negative Syndrome Scale (PANSS)|The change from baseline on the Positive and Negative Syndrome Scale (PANSS).The PANNS has three subscales: positive (score range 7-49), negative (score range 7-49), and general psychopathology (score range 16-112). The PANSS positive symptom sub-scale is comprised of 7 items rated on a scale of 1-7, representing positive symptoms of schizophrenia. The PANSS negative symptom subscale is comprised of 7 items rated on a scale of 1-7 representing the negative symptoms of schizophrenia, and the general psychopathology subscale is comprised of 16 items rated on a scale of 1-7 representing symptoms of general psychopathology in mental illness. The total score was computed by adding all the items on the sub-scale together. Scores reported are change in symptoms per week, relative to baseline. A negative score represents a decrease in total PANSS score per week, whereas a positive score represents an increase in total PANSS score per week.|Baseline vs. Week 16|Participants analyzed were those who completed at least 1 post-baseline visit or more (n = 135). 120 participants completed the study to the week 16 endpoint; however, 15 participants did not complete the entire 16 weeks, but completed at least one post-baseline study visit where the PANSS assessment was performed.||units on a scale||95% Confidence Interval|Mean
757942|NCT00611884|Secondary|Physical Examination|Physical examination was performed at screening (Week -4), randomisation (Week 0) and after 8 and 16 weeks of treatment. If any new findings or deterioration in previous findings were observed during the trial, these were recorded as AEs and are therefore not presented separately as no analysis was performed.|Week -4, Week 0, Week 8, Week 16||||||
757943|NCT00611884|Secondary|Vital Signs: Pulse|Mean values at baseline (Week 0) and at Week 16|Week 0, Week 16|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||beats/minute||Standard Deviation|Mean
757944|NCT00611884|Secondary|Vital Signs: Systolic Blood Pressure (BP)|Mean values at baseline (Week 0) and at Week 16|Week 0, Week 16|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||mmHg||Standard Deviation|Mean
757945|NCT00611884|Secondary|Vital Signs: Diastolic Blood Pressure (BP)|Mean values at baseline (Week 0) and at Week 16|Week 0, Week 16|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||mmHg||Standard Deviation|Mean
757946|NCT00611884|Secondary|Laboratory Safety Parameters (Biochemistry): Serum Creatinine|Mean values at Week -4 and at Week 16|Week -4, Week 16|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||umol/L||Standard Deviation|Mean
757947|NCT00611884|Secondary|Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT)|Mean values at Week -4 and at Week 16|Week -4, Week 16|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||IU/L||Standard Deviation|Mean
757948|NCT00611884|Secondary|Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT)|Mean values at Week -4 and at Week 16|Week -4, Week 16|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||IU/L||Standard Deviation|Mean
757949|NCT00611884|Secondary|Rate of Treatment Emergent Adverse Events (AEs)|Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject’s daily activities. Moderate: marked symptoms, moderate interference with subject’s daily activities. Severe: considerable interference with subject’s daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.|Week 0 to Week 16 + 5 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||Events/100 years of patient exposure|||Number
757950|NCT00611884|Secondary|Rate of Nocturnal Major and Minor Hypoglycaemic Episodes|Rate of nocturnal major and minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Episodes were defined as nocturnal if the time of onset was between 23:00 (included) and 05:59 (included).|Week 0 to Week 16 + 5 days follow up|The full analysis set (FAS) included all randomised subjects.||Episodes/100 years of patient exposure|||Number
757951|NCT00611884|Secondary|Rate of Major and Minor Hypoglycaemic Episodes|Rate of major and minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 16 + 5 days follow up|The full analysis set (FAS) included all randomised subjects.||Episodes/100 years of patient exposure|||Number
757952|NCT00611884|Secondary|Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)|Mean of SMPG after 16 weeks of treatment. Plasma glucose measured: before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, before bedtime, at 4 am and before breakfast.|Week 16|The full analysis set (FAS) included all randomised subjects and missing data is imputed using last observation carried forward (LOCF).||mmol/L||Standard Error|Least Squares Mean
757953|NCT00611884|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Change from baseline in HbA1c after 16 weeks of treatment|Week 0, Week 16|The full analysis set (FAS) included all randomised subjects and missing data is imputed using last observation carried forward (LOCF).||percentage of glycosylated haemoglobin||Standard Deviation|Mean
757954|NCT00611897|Secondary|Mismatch Negativity (MMN) Duration|"Mismatch Negativity (MMN) Duration difference waves at midline electrodes (Fz, Cz and Pz).
The frequent standard tones were of 75 ms duration with 5 ms rise and fall time, and were composed of 500, 1000, and 1500 Hz sinusoidal partials (harmonics) that resulted in a single high pitched beep sound.
All tones were presented at 76 dB sound pressure level (SPL) with the exception of intensity deviants. The three deviants were distinguishable from standard tones in either intensity, frequency, or duration.
Subjects performed a visual discrimination distractor task during the MMN runs and were instructed to ignore the tones.
The mismatch negativity (MMN) measure included 3 types of deviant tones (stimuli) that the subjects heard: 1. Frequency deviant, 2. Intensity deviant, 3. Duration deviant. The response to these 3 types of deviants were recorded in the EEG. Therefore each deviant was associated with different waves which we measured in amplitude (microvolts)"|daily|Per protocol||microvolts||Standard Error|Least Squares Mean
757955|NCT00611897|Secondary|Mismatch Negativity (MMN) Frequency|"Mismatch Negativity (MMN) Frequency difference waves at midline electrodes (Fx, Cz and Pz).
The frequent standard tones were of 75 ms duration with 5 ms rise and fall time, and were composed of 500, 1000, and 1500 Hz sinusoidal partials (harmonics) that resulted in a single high pitched beep sound.
All tones were presented at 76 dB sound pressure level (SPL) with the exception of intensity deviants. The three deviants were distinguishable from standard tones in either intensity, frequency, or duration.
Subjects performed a visual discrimination distractor task during the MMN runs and were instructed to ignore the tones.
The mismatch negativity (MMN) measure included 3 types of deviant tones (stimuli) that the subjects heard: 1. Frequency deviant, 2. Intensity deviant, 3. Duration deviant. The response to these 3 types of deviants were recorded in the EEG. Therefore each deviant was associated with different waves which we measured in amplitude (microvolts)"|daily|Per protocol||microvolts||Standard Error|Least Squares Mean
757956|NCT00611897|Primary|Novel P300|"The Novel P300 measures were obtained from the Fz, Cz and Pz electrodes.
Target stimuli were 1000 Hz tones (500 ms) and novel stimuli (~250 ms) were unique environmental sounds (e.g., dog bark) used in prior studies of the novelty P300. Subjects were instructed to respond to the target sounds by pressing a button using their dominant hand index finger. The standard stimuli were 20, 30 or 40 Hz click trains (500 ms) in the first, second, and third runs, respectively. The auditory steady state EEG driving data obtained from these standard stimuli will be presented in a separate report. All stimuli were presented at 80 dB SPL."|daily|Per protocol||microvolts||Standard Error|Least Squares Mean
757957|NCT00611897|Secondary|Mismatch Negativity (MMN) Intensity|"Mismatch Negativity (MMN) Intensity difference waves at midline electrodes (Fz, Cz and Pz).
The frequent standard tones were of 75 ms duration with 5 ms rise and fall time, and were composed of 500, 1000, and 1500 Hz sinusoidal partials (harmonics) that resulted in a single high pitched beep sound.
All tones were presented at 76 dB sound pressure level (SPL) with the exception of intensity deviants. The three deviants were distinguishable from standard tones in either intensity, frequency, or duration.
Subjects performed a visual discrimination distractor task during the MMN runs and were instructed to ignore the tones.
The mismatch negativity (MMN) measure included 3 types of deviant tones (stimuli) that the subjects heard: 1. Frequency deviant, 2. Intensity deviant, 3. Duration deviant. The response to these 3 types of deviants were recorded in the EEG. Therefore each deviant was associated with different waves which we measured in amplitude (microvolts)"|daily|Per protocol||microvolts||Standard Error|Least Squares Mean
757958|NCT00611897|Primary|Target P300|"The Target P300 measures were obtained from the Fz, Cz and Pz electrodes.
Target stimuli were 1000 Hz tones (500 ms) and novel stimuli (~250 ms) were unique environmental sounds (e.g., dog bark) used in prior studies of the novelty P300. Subjects were instructed to respond to the target sounds by pressing a button using their dominant hand index finger. The standard stimuli were 20, 30 or 40 Hz click trains (500 ms) in the first, second, and third runs, respectively. The auditory steady state EEG driving data obtained from these standard stimuli will be presented in a separate report. All stimuli were presented at 80 dB SPL."|daily|Per protocol||microvolts||Standard Error|Least Squares Mean
757959|NCT00612040|Secondary|Physical Examination|Physical examination was performed at screening (week -1), and after 8 and 16 weeks of treatment. If any new findings or deterioration in previous findings were observed during the trial, these were recorded as AEs and are therefore not presented separately as no analysis was performed.|Week -1, Week 8, Week 16||||||
757960|NCT00612040|Secondary|Vital Signs: Pulse|Values at baseline (Week 0) and at Week 16|Week 0, Week 16|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. From the SAS, 57 (SIBA E) and 57 (IGlar) subjects contributed to the analysis at week 16.||beats/minute||Standard Deviation|Mean
757961|NCT00612040|Secondary|Vital Signs: Systolic BP (Blood Pressure)|Values at baseline (Week 0) and at Week 16|Week 0, Week 16|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. From the SAS, 57 (SIBA E) and 57 (IGlar) subjects contributed to the analysis at week 16.||mmHg||Standard Deviation|Mean
757962|NCT00612040|Secondary|Vital Signs: Diastolic BP (Blood Pressure)|Values at baseline (Week 0) and at Week 16|Week 0, Week 16|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. From the SAS, 57 (SIBA E) and 57 (IGlar) subjects contributed to the analysis at week 16.||mmHg||Standard Deviation|Mean
757963|NCT00612040|Secondary|Laboratory Safety Parameters (Biochemistry): Serum Creatinine|Laboratory values at screening (Week -1) and at Week 16|Week -1, Week 16|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. From the SAS, 55 (SIBA D), 53 (SIBA E) and 54 (IGlar) subjects contributed to the analysis at week 16.||umol/L||Standard Deviation|Mean
757964|NCT00612040|Secondary|Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT)|Laboratory values at screening (Week -1) and at Week 16|Week -1, Week 16|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. From the SAS, 55 (SIBA D), 53 (SIBA E) and 54 (IGlar) subjects contributed to the analysis at week 16.||IU/L||Standard Deviation|Mean
772068|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 5|Subject Satisfaction - ease of deflation|3 months post-surgery|||% satisfactory or somewhat satisfactory|||Number
757965|NCT00612040|Secondary|Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT)|Laboratory values at screening (Week -1) and at Week 16|Week -1, Week 16|The safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or its comparator. From the SAS, 55 (SIBA D), 53 (SIBA E) and 54 (IGlar) subjects contributed to the analysis at week 16.||IU/L||Standard Deviation|Mean
757966|NCT00612040|Secondary|Rate of Treatment Emergent Adverse Events (AEs)|Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject’s daily activities. Moderate: marked symptoms, moderate interference with subject’s daily activities. Severe: considerable interference with subject’s daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.|Week 0 to Week 16 + 5 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||Events/100 years of patient exposure|||Number
757967|NCT00612040|Secondary|Rate of Nocturnal Major and Minor Hypoglycaemic Episodes|Rate of nocturnal major and minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Episodes were defined as nocturnal if the time of onset was between 23:00 (included) and 06:00 (excluded).|Week 0 to Week 16 + 5 days follow up|The full analysis set (FAS) included all randomised subjects.||Episodes/100 years of patient exposure|||Number
757968|NCT00612040|Secondary|Rate of Major and Minor Hypoglycaemic Episodes|Rate of major and minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 16 + 5 days follow up|The full analysis set (FAS) included all randomised subjects.||Episodes/100 years of patient exposure|||Number
757969|NCT00612040|Secondary|Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)|Estimate of the overall mean of SMPG (expressed in mmol/L, 1 mg/dL = 18times mmol/L) after 16 weeks of treatment. Plasma glucose measured: before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, bedtime, at 4 am and before breakfast.|Week 16|The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF).||mmol/L||Standard Error|Least Squares Mean
757970|NCT00612040|Secondary|Change in Fasting Plasma Glucose (FPG)|Change from baseline in FPG (expressed in mmol/L, 1 mg/dL = 18times mmol/L) after 16 weeks of treatment|Week 0, Week 16|The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF).||mmol/L||Standard Deviation|Mean
757971|NCT00612040|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Change from baseline in HbA1c after 16 weeks of treatment|Week 0, Week 16|The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF).||percentage of glycosylated haemoglobin||Standard Deviation|Mean
757972|NCT00612066|Primary|Number of Responders|"Definition of Treatment Response
The primary outcome in Cushing's disease will the % responders, a responder is defined as a patient with 2 consecutive 24h urinary free cortisols within the normal reference range in association with no clinical signs of disease progression.
Secondary outcomes will include the % reduction in 24h UFC (derived by comparison of the mean of 2 baseline 24h UFC values with mean of the two lowest consecutive 24h UFC values while on study treatment in association with no clinical signs of disease progression)."|7 weeks|Sample size was too small to do a valid analysis.||participants|||Number
757973|NCT00612105|Secondary|"Change From Baseline in the Average Diary Pain Score to the Last 7 Days of the Maintenance Phase by Post Herpetic Neuralgia (PHN) Subtype Unclassifiable"|"Participants stratified into 4 different PHN subtypes based on NPPE. Participants who could not be specifically differentiated in any of the other three subtypes were stratified as unclassifiable meaning that the participants could not be classified into any of the predefined PHN subtypes. Based on their pain experienced during the previous 24 hours, participants assessed their pain every evening at bedtime in an electronic diary by choosing the appropriate number on an 11-point NRS: 0, no pain; 1 to 3, mild; 4 to 6, moderate; 7 to 10, severe pain."|Baseline and Week 4 Maintenance Phase (MP)|ITT Population. Only participants in the specified subgroup were analyzed.||Scores on a scale||Standard Deviation|Mean
757974|NCT00612105|Secondary|"Change From Baseline in the Average Diary Pain Score to the Last 7 Days of the Maintenance Phase by Post Herpetic Neuralgia (PHN) Subtype Deafferentation Type 2 (D Type 2)"|"Participants stratified into 4 different PHN subtypes based on NPPE. Participants with marked sensory loss and severe spontaneous burning pain without allodynia associated with reorganization of central nerve fibers were stratified in the “deafferentation type 2 subtype. Based on their pain experienced during the previous 24 hours, participants assessed their pain every evening at bedtime in an electronic diary by choosing the appropriate number on an 11-point NRS: 0, no pain; 1 to 3, mild; 4 to 6, moderate; 7 to 10, severe pain."|Baseline and Week 4 Maintenance phase (MP)|ITT Population. Only participants in the specified subgroup were analyzed.||Scores on a scale||Standard Deviation|Mean
757975|NCT00612105|Secondary|"Change From Baseline in the Average Diary Pain Score to the Last 7 Days of the Maintenance Phase by Post Herpetic Neuralgia (PHN) SubtypeDeafferentation Type 1 (D Type 1)"|"Participants stratified into 4 different PHN subtypes based on NPPE. Participants with marked sensory loss associated with severe burning pain upon slight mechanical stimuli (allodynia) were stratified in the deafferentation type 1 subtype. Based on their pain experienced during the previous 24 hours, participants assessed their pain every evening at bedtime in an electronic diary by choosing the appropriate number on an 11-point NRS: 0, no pain; 1 to 3, mild; 4 to 6, moderate; 7 to 10, severe pain."|Baseline and Week 4 Maintenance Phase (MP)|ITT Population. Only participants in the specified subgroup were analyzed.||Scores on a scale||Standard Deviation|Mean
758003|NCT00612313|Primary|Relapse|"Relapse was defined as:
1) CDRS-R score >=40 with a history of 2 weeks of clinical deterioration or 2) CDRS-R<40, but with a 2 week history of significant clinical deterioration."|Measured at Weeks 12, 18, 24, and 30|Only participants who achieved remission were analyzed for relapse rates, as only remitted patients can experience a relapse of depression.||probability of relapse (%)|||Number
758004|NCT00612313|Primary|Time to Remission|Remission is defined as CDRS-R <=28. Timing of remission is based on clinical assessment using the CDRS-R and K-Life to identify the week at which point the patient remitted.|30 weeks|||weeks||Standard Error|Mean
757976|NCT00612105|Secondary|"Change From Baseline in the Average Diary Pain Score to the Last 7 Days of the Maintenance Phase by Post Herpetic Neuralgia (PHN) Subtype Irritable Nociceptors"|"Participants were stratified into four different PHN subtypes based on the NPPE. Participants with pain, abnormal sensitization of the specific receptor (irritable nociceptors), and with minimal sensory loss were stratified in theirritable nociceptors subtype. Based on their pain experienced during the previous 24 hours, participants assessed their pain every evening at bedtime in an electronic diary by choosing the appropriate number on an 11-point NRS: 0, no pain; 1 to 3, mild; 4 to 6, moderate; 7 to 10, severe pain."|Baseline and Week 4 Maintenance Phase (MP)|ITT Population. Only participants in the specified subgroup were analyzed.||Scores on a scale||Standard Deviation|Mean
757977|NCT00612105|Secondary|Number of Participants With Indicated Responses at the End of the MP to the Questions: “How Sharp Was the Affected Side Compared to the Opposite Side?” and “How Painful Was the Affected Side Compared to the Opposite Side?” in an Assessment of Hyperalgesia|"At the end of the MP, the investigator conducted the NPPE (an examination of the effect of retigabine on sensory abnormalities) to examine hyperalgesia and allodynia (tactile and cold). Hyperalgesia is defined as increased sensitivity to pain, which may be caused by damage to peripheral nerves. It was assessed with a pinprick brush, based on the questions:How sharp was the affected side compared to the opposite side? and How painful was the affected side compared to the opposite side?"|End of Maintenance Phase (MP) (Week 4)|ITT Population includes all participants who entered MP and provided data. End of Maintenance Phase includes participants who completed Week 4 of the MP and who terminated early during the MP.||Participants|||Number
757978|NCT00612105|Secondary|Number of Participants With the Indicated Responses at the End of the MP to the Questions of “Is it Cool?” and “Is it Painful?” in an Assessment of Cold Threshold and Allodynia|"At the end of the MP, the investigator conducted the NPPE (an examination of the effect of retigabine on sensory abnormalities) to examine hyperalgesia and allodynia (tactile and cold). Cold threshold and allodynia was assessed to determine if a metal bar felt cool and if it felt painful, based on the questions:Is it cool? and Is it painful?"|End of Maintenance Phase (MP) (Week 4)|ITT Population includes all participants who entered MP and provided data. End of Maintenance Phase includes participants who completed Week 4 of the MP and who terminated early during the MP.||Participants|||Number
757979|NCT00612105|Secondary|Number of Participants With the Indicated Responses at the End of the MP to the Question: “How Painful Was the Affected Side Compared to the Opposite Side?” in an Assessment of Tactile Allodynia|"At the end of the MP, the investigator conducted the NPPE (an examination of the effect of retigabine on sensory abnormalities) to examine hyperalgesia and allodynia (tactile and cold). Tactile allodynia was assessed with a foam brush, based on the question:How painful was the affected side compared to the opposite side? End of Maintenance Phase includes participants who completed Week 4 of the MP and who terminated early during the MP."|End of Maintenance Phase (MP) (Week 4)|ITT Population includes all participants who entered MP and provided data. End of Maintenance Phase includes participants who completed Week 4 of the MP and who terminated early during the MP.||Participants|||Number
757980|NCT00612105|Secondary|Number of Participants With the Indicated Responses at Baseline to the Questions: “How Sharp Was the Affected Side Compared to the Opposite Side?” and “How Painful Was the Affected Side Compared to the Opposite Side?” in an Assessment of Hyperalgesia|"At Baseline the investigator conducted the NPPE to examine hyperalgesia and allodynia (tactile and cold). Hyperalgesia is defined as increased sensitivity to pain, which may be caused by damage to peripheral nerves. It was assessed with a pinprick brush, based on the questions: How sharp was the affected side compared to the opposite side? and How painful was the affected side compared to the opposite side?"|Baseline Phase (Day -7 to Randomization Day 0)|ITT Population - All participants providing data for the measure are included in the analysis. Differences from the overall population numbers are due to missing data or to subjects missing visits.||Participants|||Number
757981|NCT00612105|Secondary|Number of Participants With the Indicated Responses at Baseline to the Questions of “Is it Cool?” and “Is it Painful?” in an Assessment of Cold Threshold and Allodynia|"At Baseline the investigator conducted the NPPE to examine hyperalgesia and allodynia (tactile and cold). Cold threshold and allodynia was assessed to determine if a metal bar felt cool and if it felt painful, based on the questions:Is it cool? and Is it painful?"|Timeframe: Baseline Phase (Day -7 to Randomization Day 0)|ITT Population - All participants providing data for the measure are included in the analysis. Differences from the overall population numbers are due to missing data or to subjects missing visits.||Participants|||Number
757982|NCT00612105|Secondary|Number of Participants With the Indicated Responses at Baseline to the Question: “How Painful Was the Affected Side Compared to the Opposite Side?” in an Assessment of Tactile Allodynia|"At Baseline, the investigator conducted the Neuropathic Pain Physical Examination (NPPE) to examine hyperalgesia and allodynia (tactile and cold). Tactile allodynia was assessed with a foam brush, based on the question:How painful was the affected side compared to the opposite side?."|Baseline Phase (Day -7 to Randomization Day 0)|ITT Population - All participants providing data for the measure are included in the analysis. Differences from the overall population numbers are due to missing data or to subjects missing visits.||Participants|||Number
757983|NCT00612105|Secondary|Scores for Reported Health Transition at the End of the MP for All Participants Who Completed Week 4 of the MP and Who Terminated Early During the MP|"The least square (LS) mean score for reported health transition was calculated based on the scores (ranging from 1 to 5) given by the participant in answer to the following question: Compared to 1 year ago, how would you rate your health in general now?”. Lower numbers represent a better state of health."|End of maintenance Phase (MP) (Week 4)|ITT Population includes all participants who entered MP and provided data. End of Maintenance Phase includes participants who completed Week 4 of the MP and who terminated early during the MP. Differences from the overall population numbers are due to missing data or to participants missing visits.||Scores on a scale||Standard Error|Least Squares Mean
758024|NCT00612352|Secondary|Visual Analog Scale (VAS) HIGH - 140 Minutes|visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)|140 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
758025|NCT00612352|Secondary|Visual Analog Scale (VAS) HIGH - 110 Minutes|visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)|110 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
757984|NCT00612105|Secondary|Scores on the Medical Outcomes Short Form-36 (SF-36) at the End of the MP for All Participants Who Completed Week 4 of the MP and Who Terminated Early During the MP|Least square (LS) mean calculated based on participant's assessment of SF-36,a quality of life questionnaire consisting of 36 items grouped into 8 domains. These 8 domains further grouped into 2 overall summary measures,physical health and mental health. Higher scores on SF-36 represented better state of health. Physical/mental components summarized the data of all the physical/mental domains of SF-36 and higher scores represented better state of health.|End of Maintenance Phase (MP) (Week 4)|ITT Population includes all participants who entered MP and provided data. End of Maintenance Phase includes participants who completed Week 4 of the MP and who terminated early during the MP. Differences from the overall population numbers are due to missing data or to participants missing visits.||Scores on a scale||Standard Error|Least Squares Mean
757985|NCT00612105|Secondary|Scores on the Brief Pain Inventory-Short Form (BPI-SF) at the End of the MP for All Participants Who Completed Week-4 of the MP and Who Terminated Early During the MP|The BPI-SF assessed pain intensity, pain relief from medication, and pain interference with function over the previous 24 hours. Pain intensity was assessed by the mean of 4 intensity items rated on a 0-10 categorical scale: 0=no pain, 10=pain as bad as you can imagine. Pain interference was assessed by determining the mean of the 7 interference items on a 0-10 categorical scale ranging from 0=does not interfere to 10=completely interferes. The level of pain relief provided by treatment was assessed on an 11-point categorical scale ranging from 0% to 100%|End of Maintenance Phase (MP) (Week 4)|ITT Population includes all participants who entered MP and provided data. End of Maintenance Phase includes participants who completed Week 4 of the MP and who terminated early during the MP. Differences from the overall population numbers are due to missing data or to participants missing visits.||Scores on a scale||Standard Deviation|Mean
757986|NCT00612105|Secondary|Mean Score on the Treatment Satisfaction Questionnaire for Medication (TSQM) at the End of the Maintenance Phase|The TSQM assessed the participant's overall satisfaction with treatment, including subscales to assess effectiveness, side effects, convenience, and global satisfaction. Raw scores from the scale were transformed into a numeric scale ranging from 0 to 100, where higher scores indicated greater satisfaction with treatment. TSQM was reported at the end of the MP. Participants who completed Week 4 of the MP and who terminated early during the MP were assessed.|End of Maintenance Phase (MP) (Week 4)|ITT Population includes all participants who entered MP and provided data. End of Maintenance Phase includes participants who completed Week 4 of the MP and who terminated early during the MP. Differences from the overall population numbers are due to missing data or to participants missing visits.||Scores on a scale||Standard Deviation|Mean
757987|NCT00612105|Secondary|Number of Participants With the Indicated Overall Patient Global Impression of Change (PGIC)|For the PGIC assessment, participants were asked to assess their overall status since they initiated the study drug to the end of the Maintenance Phase using a 7-point categorical scale: 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse. All participants who completed Week 4 of the Maintenance Phase and participants who terminated early during the Maintenance Phase were assessed.|Baseline to the end of Maintenance Phase (MP) (Week 4)|ITT Population includes all participants who entered MP and provided data. End of Maintenance Phase includes participants who completed Week 4 of the MP and who terminated early during the MP.||Participants|||Number
757988|NCT00612105|Secondary|Number of Participants With the Indicated Change From Baseline to the End of the Maintenance Phase in Optimal Sleep Based on the Sleep Quantity Domain of the MOS Sleep Scale|"Optimal Sleep was based on the Sleep Quantity domain of the MOS Sleep Scale and included the options of Yes if sleep quantity was 7-8 hours, and No otherwise. Improved indicated a change in response of no at baseline to yes at the end of the MP, Same indicated no change in response, and Worse indicated a change in response from yes at baseline to no at the end of the MP."|Baseline and End of Maintenance Phase (MP) (Week 4).|ITT Population includes all participants who entered MP and provided data. End of Maintenance Phase includes participants who completed Week 4 of the MP and who terminated early during the MP.||Participants|||Number
757989|NCT00612105|Secondary|Change From Baseline to the End of the MP (Included All Participants Who Completed Week 4 of the MP and Who Terminated Early During the MP) in Sleep Quantity|Change from Baseline in sleep quantity was calculated by subtracting the average value of sleep quantity, calculated in hours, at the end of the MP from the average Baseline value.|Baseline and End of Maintenance Phase (MP) (Week 4).|ITT Population includes all participants who entered MP and provided data. End of Maintenance Phase includes participants who completed Week 4 of the MP and who terminated early during the MP.||Hours||Standard Deviation|Mean
757990|NCT00612105|Secondary|Change From Baseline to the End of the MP (Included All Participants Who Completed Week 4 of the MP and Who Terminated Early During the MP) in Medical Outcomes Study (MOS) Sleep Scale Scores|Change from BL (average value of MOS Sleep Scale score including Overall Sleep Problem [OSP] Index at end of MP minus average BL value) to the end of the MP was summarized for the OSP Index, in addition to the following subscales of the MOS Sleep Scale: Sleep Disturbance; Sleep Adequacy; Snoring; Awakening with Shortness of Breath or with a Headache; Somnolence; and Optimal Sleep. Each item was transformed to a scale with a range of 0-100. For each subscale, except Optimal Sleep, higher scores indicate a greater level of what was being measured (i.e., more snoring, more sleep adequacy, etc.).|Baseline and End of Maintenance Phase (MP) (Week 4).|ITT Population includes all participants who entered MP and provided data. End of Maintenance Phase includes participants who completed Week 4 of the MP and who terminated early during the MP.||Scores on a scale||Standard Deviation|Mean
757991|NCT00612105|Secondary|Number of Participants Classified as Responders, With a 50% and 30% Pain Reduction From Baseline to the Last 7 Days of the Maintenance Phase|Responders were defined as participants achieving a mean >=50% or >=30% pain reduction based on the NRS score from Baseline to the last 7 days of the MP. Those participants who did not have at least 3 diary entries in the MP, those who withdrew during the Titration Phase (TP), and non-completers (NC: who did not complete the study) were classified as non-responders. The number of responders and responders including non-completers from Baseline to the last 7 days of the MP were reported.|Baseline and Week 4 Maintenance Phase (MP)|ITT Population. All participants providing data for this analysis had to have 7 available baseline diary entries.||Participants|||Number
758026|NCT00612352|Secondary|Visual Analog Scale (VAS) HIGH - 60 Minutes|visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)|60 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
757992|NCT00612105|Secondary|Change From Baseline in Pain Intensity Score at Each Week During the Maintenance Phase (MP)|Least square mean (LSM) of pain intensity was calculated from the NRS score entered by the participants in their diaries at each week during the MP. Participants rated their pain during the previous 24 hours at all clinic visits using an NRS: 0, no pain; 1-3, mild; 4-6, moderate; 7-10 (worst possible pain), severe pain. Change from Baseline was calculated by subtracting the value of the average of the LSM of the NRS score at each week during the MP (the last 7 available diary entries in the MP were used, provided at least 3 existed) from the average Baseline value of the LSM of the NRS score.|Baseline and Weeks 1, 2, 3, and 4 (MP)|ITT Population. All participants providing data for the measure are included in the analysis. Differences from the overall population numbers are due to missing data or to subjects missing visits.||Scores on a scale||Standard Deviation|Mean
757993|NCT00612105|Secondary|Number of Rescue Medication Tablets Taken Per Day During the Maintenance Phase (MP)|Participants recorded the number of acetaminophen tablets taken during the previous 24 hours in a participant diary. Rescue medication was summarized as the mean number of doses taken per day during each week of the Maintenance Phase (MP) and the mean number of doses taken during all MP weeks.|Weeks 1, 2, 3, and 4 Maintenance Phase|ITT Population. All participants providing data for the measure are included in the analysis. Differences from the overall population numbers are due to missing data or to subjects missing visits.||Tablets/Day||Standard Deviation|Mean
757994|NCT00612105|Secondary|Change From Baseline to Weeks 2 and 4 of the Maintenance Phase in Mean In-clinic Pain Assessment|Participants rated their pain during the previous 24 hours at all clinic visits using an 11-point Numerical Rating Scale (NRS): 0, no pain; 1 to 3, mild; 4 to 6, moderate; 7 to 10, severe pain (10=worst possible pain). Change in In-clinic Pain Assessment was calculated by subtracting the average score on the NRS at Week 2 and Week 4 (values for each week were observed cases) of the MP from the average score on the NRS at Baseline (the last non-missing measurement prior to taking study drug).|Baseline and Weeks 2 and 4 (Maintenance Phase - MP)|Intent-to-Treat (ITT) Population: all randomized participants who took at least one dose of study medication and had at least one post-randomization efficacy assessment. All participants providing data for the measure are included in the analysis. Differences from the overall population numbers are due to missing data or to subjects missing visits.||Scores on a scale||Standard Deviation|Mean
757995|NCT00612105|Primary|Primary Endpoint Will be the Change From Baseline in Average Pain Score Over the Last 7 Days of the Maintenance Phase.|Change from Baseline (BL) was calculated as the value of the average diary pain score for the last 7 days of the MP minus the value of the average pain score at BL (post wash-out period, including the average of the last 7 available entries prior to/including the diary pain measurement on Titration Day 0). Based on their pain experienced during the previous 24 hours, participants assessed their pain every evening at bedtime in an electronic diary by choosing the appropriate number on an 11-point Numerical Rating Scale (NRS): 0, no pain; 1 to 3, mild; 4 to 6, moderate; 7 to 10, severe pain.|Baseline and Week 4 (Maintenance Phase-MP)|Per Protocol (PP) Population: all randomized participants who completed the Titration Phase, had at least 1 dose of treatment in the MP, had at least 3 diary entries in the MP, and did not have any protocol violations or any major protocol deviations||Scores on a scale||Standard Error|Least Squares Mean
757996|NCT00612222|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|15 months|||Participants|||Number
757997|NCT00612222|Secondary|Number of Participants With in Vivo Survival of T-cell Receptor (TCR) Gene-engineered Cells|T cell receptor (TCR) and vector presence will be quantitated in peripheral blood mononuclear cells (PBMC) samples using established polymerase chain reaction (PCR) techniques. This will provide data to estimate the in vivo survival of lymphocytes derived from the infused cells.|1 month|This outcome measure was not done because the study was terminated due to low accrual.|||||
757998|NCT00612222|Primary|Number of Participants With Metastatic Melanoma Who Develop Clinical Tumor Regression (CR or PR)|Clinical tumor response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 criteria. Complete response (CR) is a disappearance of all target lesions. Partial response (PR) is a 30% decrease in lesions taking as reference the baseline sum longest diameter (LD). For details about the RECIST criteria see the protocol link module.|4-6 weeks after treatment and then monthly for approximately 3 to 4 months or until off study criteria are met|||Participants|||Number
757999|NCT00612313|Primary|Remission|Remission is defined as CDRS-R <=28.|Measured at Weeks 12, 18, 24, and 30|||probability of remitting (%)|||Number
758000|NCT00612313|Secondary|Relapse|"Up through week 30, relapse was defined as:
1) CDRS-R score >=40 with a history of 2 weeks of clinical deterioration or 2) CDRS-R<40, but with a 2 week history of significant clinical deterioration.
From week 31-78, relapse was assessed using the K-Life. Relapse was defined as at least 2 weeks of a K-Life rating of 5 or 6; participants may also be identified as relapsing with a K-Life rating of 4 if the rating was for several weeks and not strictly related to stressful life events."|Weeks 52 and 78|Only participants who achieved remission were analyzed for relapse rates, as only remitted patients can experience a relapse of depression.||Probability of Relapse (%)|||Number
758001|NCT00612313|Secondary|Remission|Remission is defined as CDRS-R <=28 (up through week 30) or at least 8 consecutive weeks of a K-Life rating of 1 or 2. Timing of remission is based on clinical assessment using the CDRS-R and K-Life to identify the week at which point the patient remitted.|Weeks 52 and 78|||Probability of remission (%)|||Number
758002|NCT00612313|Secondary|K-Life (Time Well)|"K-Life interview was conducted at Weeks 6, 12, 18, 24, and 30, with ratings for depressive illness for each week throughout the study.
Ratings definitions: 1=Normal, no residual symptoms; 2=Presence of 1 or more symptosm in no more than mild degree; 3=Considerably less psychopathology than full criteria, but still obvious evidence of disorder with no more than moderate impairment; 4=Does not meet full criteria, but has major symptoms or impairment from the disorder; 5=Meets full criteria, but no extreme impairment; 6=Meets full criteria, and either has prominent psychotic symptoms or extreme impairment.
Time well is defined as each week the depression rating was a 1 or 2. Percent time well was defined as each week the depression rating was a 1 or 2 divided by the total number of weeks in the study.
Statistic: anova"|30 weeks|||Weeks spent well||Standard Deviation|Mean
758027|NCT00612352|Secondary|Visual Analog Scale (VAS) HIGH - 30 Minutes|visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)|30 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
758005|NCT00612339|Primary|Response Rate|The proportion of subjects with complete or partial response as determined by a modification of the RANO (Response Assessment in Neuro-Oncology) criteria. A confirmation of response was not required. Complete Response was defined as complete disappearance on MR/CT of all enhancing tumor and mass effect, off all corticosteroids (or receiving only adrenal replacement doses), accompanied by a stable or improving neurologic examination, and maintained for at least 4 weeks. Partial Response was defined as greater than or equal to 50% reduction in tumor size on MR/CT by bi-dimensional measurement, on a stable or decreasing dose of corticosteroids, accompanied by a stable or improving neurologic examination, and maintained for at least 4 weeks.|4 months|All subjects||percentage of patients||95% Confidence Interval|Number
758006|NCT00612352|Secondary|Pegboard Task - Baseline (Non-Dominant Hand)|The pegboard task is a measure of coordination that measures reaction time; how long a subject takes to insert pegs into a pegboard puzzle, first using their dominant hand then using their non-dominant hand. A quicker time indicates greater coordination. Scores are timed in seconds.|30 minutes|All available data was utilized in the analysis using mixed models.||seconds||Standard Deviation|Mean
758007|NCT00612352|Secondary|Pegboard Task - Baseline (Non-Dominant Hand)|The pegboard task is a measure of coordination that measures reaction time; how long a subject takes to insert pegs into a pegboard puzzle, first using their dominant hand then using their non-dominant hand. A quicker time indicates greater coordination. Scores are timed in seconds.|Baseline|All available data was utilized in the analysis using mixed models.||seconds||Standard Deviation|Mean
758008|NCT00612352|Secondary|Pegboard Task - Baseline (Dominant Hand)|The pegboard task is a measure of coordination that measures reaction time; how long a subject takes to insert pegs into a pegboard puzzle, first using their dominant hand then using their non-dominant hand. A quicker time indicates greater coordination. Scores are timed in seconds.|30 minutes|All available data was utilized in the analysis using mixed models.||seconds||Standard Deviation|Mean
758009|NCT00612352|Secondary|Pegboard Task - Baseline (Dominant Hand)|The pegboard task is a measure of coordination that measures reaction time; how long a subject takes to insert pegs into a pegboard puzzle, first using their dominant hand then using their non-dominant hand. A quicker time indicates greater coordination. Scores are timed in seconds|Baseline|All available data was utilized in the analysis using mixed models.||seconds||Standard Deviation|Mean
758010|NCT00612352|Secondary|Hopkins Verbal Learning Task - Delay Recall|Hopkins Verbal Learning Task (HVLT) - measures verbal memory and hippocampus function. (Delay Recall: 30 minutes after Trials 1-3 were given) (0 no words recalled - 12 all words recalled)|60 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
758011|NCT00612352|Secondary|Hopkins Verbal Learning Task - Immediate Recall - Trial 3|Hopkins Verbal Learning Task (HVLT) - measures verbal memory and hippocampus function. (Three immediate recall trials) (0 no words recalled - 12 all words recalled)|30 minutes - Trial 3|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
758012|NCT00612352|Secondary|Hopkins Verbal Learning Task - Immediate Recall - Trial 2|Hopkins Verbal Learning Task (HVLT) - measures verbal memory and hippocampus function. (Three immediate recall trials) (0 no words recalled - 12 all words recalled)|30 minutes - Trial 2|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
758013|NCT00612352|Secondary|Hopkins Verbal Learning Task - Immediate Recall - Trial 1|Hopkins Verbal Learning Task (HVLT) - measures verbal memory and hippocampus function. (Three immediate recall trials) (0 no words recalled - 12 all words recalled)|30 minutes - Trial 1|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
758014|NCT00612352|Secondary|Visual Analog Scale (VAS) Drowsy - 230 Minutes|visual analog scale (VAS): self-report scale used to measure Drowsy (0 not at all drowsy - 7 extremely drowsy)|230 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
758015|NCT00612352|Secondary|Visual Analog Scale (VAS) Drowsy - 170 Minutes|visual analog scale (VAS): self-report scale used to measure Drowsy (0 not at all drowsy - 7 extremely drowsy)|170 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
758016|NCT00612352|Secondary|Visual Analog Scale (VAS) Drowsy - 140 Minutes|visual analog scale (VAS): self-report scale used to measure Drowsy (0 not at all drowsy - 7 extremely drowsy)|140 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
758017|NCT00612352|Secondary|Visual Analog Scale (VAS) Drowsy - 110 Minutes|visual analog scale (VAS): self-report scale used to measure Drowsy (0 not at all drowsy - 7 extremely drowsy)|110 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
758018|NCT00612352|Secondary|Visual Analog Scale (VAS) Drowsy - 60 Minutes|visual analog scale (VAS): self-report scale used to measure Drowsy (0 not at all drowsy - 7 extremely drowsy)|60 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
758019|NCT00612352|Secondary|Visual Analog Scale (VAS) Drowsy - 30 Minutes|visual analog scale (VAS): self-report scale used to measure Drowsy (0 not at all drowsy - 7 extremely drowsy)|30 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
758020|NCT00612352|Secondary|Visual Analog Scale (VAS) Drowsy - 10 Minutes|visual analog scale (VAS): self-report scale used to measure Drowsy (0 not at all drowsy - 7 extremely drowsy)|10 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
758021|NCT00612352|Secondary|Visual Analog Scale (VAS) Drowsy - Baseline|visual analog scale (VAS): self-report scale used to measure Drowsy (0 not at all drowsy - 7 extremely drowsy)|Baseline|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
758022|NCT00612352|Secondary|Visual Analog Scale (VAS) HIGH - 240 Minutes|visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)|240 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
758023|NCT00612352|Secondary|Visual Analog Scale (VAS) HIGH - 170 Minutes|visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)|170 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
772069|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 4|Subject Satisfaction - ease of inflation|12 months post-surgery|||% satisfactory or somewhat satisfactory|||Number
758028|NCT00612352|Secondary|Visual Analog Scale (VAS) HIGH - 10 Minutes|visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)|10 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
758029|NCT00612352|Secondary|Visual Analog Scale (VAS) HIGH - Baseline|visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)|Baseline|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
758030|NCT00612352|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 240 Minutes|Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)|240 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
758031|NCT00612352|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 170 Minutes|Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)|170 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
758032|NCT00612352|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 140 Minutes|Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)|140 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
758033|NCT00612352|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 110 Minutes|Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)|110 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
758034|NCT00612352|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 60 Minutes|Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)|60 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
758035|NCT00612352|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 30 Minutes|Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)|30 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
758036|NCT00612352|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 10 Minutes|Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)|10 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
758037|NCT00612352|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - Baseline|Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)|Baseline|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
758038|NCT00612352|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 230 Minutes|Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)|230 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
758039|NCT00612352|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 170 Minutes|Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)|170 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
758040|NCT00612352|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 140 Minutes|Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)|140 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
758041|NCT00612352|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 110 Minutes|Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)|110 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
758042|NCT00612352|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 60 Minutes|Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)|60 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
758043|NCT00612352|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 30 Minutes|Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)|30 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
758044|NCT00612352|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 10 Minutes|Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)|10 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
758045|NCT00612352|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative Baseline|Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)|Baseline|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
758046|NCT00612352|Primary|Visual Analog Scale of Similarity to Alcohol - 230 Minutes|Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|230 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
758047|NCT00612352|Primary|Visual Analog Scale of Similarity to Alcohol - 170 Minutes|Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|170 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
758048|NCT00612352|Primary|Visual Analog Scale of Similarity to Alcohol - 140 Minutes|Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|140 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
758049|NCT00612352|Primary|Visual Analog Scale of Similarity to Alcohol - 110 Minutes|Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|110 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
758050|NCT00612352|Primary|Visual Analog Scale of Similarity to Alcohol - 60 Minutes|Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|60 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
758051|NCT00612352|Primary|Visual Analog Scale of Similarity to Alcohol - 30 Minutes|Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|30 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
758052|NCT00612352|Primary|Visual Analog Scale of Similarity to Alcohol -10 Minutes|Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|10 minutes|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
758053|NCT00612352|Primary|Visual Analog Scale of Similarity to Alcohol - Baseline|Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|Baseline|All available data was utilized in the analysis using mixed models.||units on a scale||Standard Deviation|Mean
758054|NCT00612352|Primary|Number of Drinks Felt Consumed at 230 Minutes|The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.|230 minutes|All available data was utilized in the analysis using mixed models.||drinks felt consumed||Standard Deviation|Mean
758055|NCT00612352|Primary|Number of Drinks Felt Consumed at 170 Minutes|The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.|170 minutes|All available data was utilized in the analysis using mixed models.||drinks felt consumed||Standard Deviation|Mean
758056|NCT00612352|Primary|Number of Drinks Felt Consumed at 140 Minutes|The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.|140 minutes|All available data was utilized in the analysis using mixed models.||drinks felt consumed||Standard Deviation|Mean
758057|NCT00612352|Primary|Number of Drinks Felt Consumed at 110 Minutes|The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.|110 minutes|All available data was utilized in the analysis using mixed models.||drinks felt consumed||Standard Deviation|Mean
758058|NCT00612352|Primary|Number of Drinks Felt Consumed at 30 Minutes|The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.|30 minutes|All available data was utilized in the analysis using mixed models.||drinks felt consumed||Standard Deviation|Mean
758059|NCT00612352|Primary|Number of Drinks Felt Consumed at 10 Minutes|The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.|10 minutes|All available data was utilized in the analysis using mixed models.||drinks felt consumed||Standard Deviation|Mean
758060|NCT00612352|Primary|Number of Drinks Felt Consumed at Baseline|The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.|Baseline|All available data was utilized in the analysis using mixed models.||drinks felt consumed||Standard Deviation|Mean
758061|NCT00612430|Secondary|Median Overall Survival (OS)|Time in weeks from the start of study treatment to date of death due to any cause. Patients alive as of the last follow-up had OS censored at the last follow-up date. Median OS was estimated using a Kaplan-Meier curve.|median of 91.4 weeks|||weeks||95% Confidence Interval|Median
758062|NCT00612430|Secondary|Median Progression-Free Survival|Time in weeks from the start of study treatment to the date of first progression, or to death due to any cause. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve.|Patients were followed for a median of 91.4 weeks|||weeks||95% Confidence Interval|Median
758063|NCT00612430|Secondary|Safety of Study Treatment Regimen|Number of participants experiencing a non-hematologic toxicity ≥ grade 3 that was possibly, probably, or definitely related to study treatment.|2 years|||participants|||Number
758064|NCT00612430|Secondary|Objective Response Rate|The percentage of participants with complete or partial response as determined by the following criteria: complete response was defined as complete disappearance on MR/CT of all enhancing tumor and mass effect, off all corticosteroids (or receiving only adrenal replacement doses), accompanied by a stable or improving neurologic examination; partial response was defined as greater than or equal to 50% reduction in tumor size on MR/CT by bi-dimensional measurement, on a stable or decreasing dose of corticosteroids, accompanied by a stable or improving neurologic examination. A confirmation of response was not required.|2 years|||percentage of participants|||Number
758065|NCT00612430|Primary|6 Month Progression-Free Survival (PFS)|Percentage of participants surviving six months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression. Progression was defined as greater than or equal to a 25% increase in the product of the largest perpendicular diameters of any enhancing lesion or any new enhancing tumor on MRI scans.|6 months|||percentage of participants||95% Confidence Interval|Number
758066|NCT00612456|Secondary|Plasma Pharmacokinetic Parameter Area Under Concentration Time-curve From Time Zero to 6 Hours (AUC [0-6)]|Blood samples for analysis of plasma pazopanib concentrations were collected over 6 hours after an ocular dose of pazopanib on Day 15 or Day 22. PK analyses of plasma pazopanib concentration-time data were conducted using non-compartmental Model 200 (for extravascular administration) of WinNonlin Professional Edition version 5.2. Data has been presented for pharmacokinetic parameter AUC (0-6) at Day 15 and Day 22.|Day 15 and Day 22|Pharmacokinetic population. Only those participants available at the specified time points were used for analysis.||nanograms per hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
758067|NCT00612456|Secondary|Plasma Pharmacokinetic Parameter Time of Occurrence of Cmax (Tmax)|Blood samples for analysis of plasma pazopanib concentrations were collected over 6 hours after an ocular dose of pazopanib on Day 15 or Day 22. PK analyses of plasma pazopanib concentration-time data were conducted using non-compartmental Model 200 (for extravascular administration) of WinNonlin Professional Edition version 5.2. Data has been presented for pharmacokinetic parameter tmax at Day 15 and Day 22.|Day 15 and Day 22|Pharmacokinetic population. Only those participants available at the specified time points were used for analysis.||hour||Full Range|Median
758068|NCT00612456|Secondary|Plasma Pharmacokinetic Parameter Maximum Observed Concentration (Cmax)|Blood samples for analysis of plasma pazopanib concentrations were collected over 6 hours after an ocular dose of pazopanib on Day 15 or Day 22. PK analyses of plasma pazopanib concentration-time data were conducted using non-compartmental Model 200 (for extravascular administration) of WinNonlin Professional Edition version 5.2. Data has been presented for pharmacokinetic parameter Cmax at Day 15 and Day 22.|Day 15 and Day 22|The pharmacokinetic population included all participants in the Safety Population who received at least one dose of active treatment and a PK sample was obtained and analyzed. Only those participants available at the specified time points were used for analysis.||nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
758069|NCT00612456|Secondary|Change From Baseline in Neovascular Size, Total Lesion Size, Fluorescein Angiography (FA) Leakage Area of Measurement, FA Blood Area of Measurement as Measured by FA at Day 29|FA uses FP to capture images of injected dye circulating throughout the retinal blood vessels to assess leaking, swelling or circulation problems caused by various eye diseases like diabetic retinopathy and wet macular degeneration. The parameters assessed were CNV size, Classic CNV size, FA blood area of measurement, FA leakage area of measurement and total lesion size. A protocol fluorescein angiogram was to be obtained at Day 29. Images were evaluated by investigator for eligibility determination, and by a central reading center for determination of PD effect. Data has been presented for change from baseline in change in eye characteristics in the study eye at Day 29. Baseline was defined as the assessments performed between Day -3 to -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-randomization value at Day 29.|Baseline (Day -3 to -1) and Day 29|PD Parameter Population. Only those participants available at the specified time point were analyzed.||millimeters||Standard Deviation|Mean
758070|NCT00612456|Secondary|Number of Participants With Change in Characteristics (Fibrosis, Atrophy, Blood) as Measured by Fundus Photography (FP)|Fundus photography involves capturing of images of the center of the very back inner wall of the eye — the retina, optic nerve, macula and main retinal blood vessels. The parameters assessment were heme subretinal hemorrhage (absence or presence at the location), heme intraretinal hemorrhage (absence or presence at the location), subretinal fluid (absence or presence at location), fibrosis (absence or presence at location), atrophy (absence or presence of atrophic changes) and pigment ((absence or presence at location). A protocol set of fundus photographs were obtained at Day 29. Images were read by the investigator for eligibility determination, and by a central reading center for determination of PD effect. Data has been presented for number of participants with changes in eye characteristics in the study eye at Day 29.|Day 29|PD Parameter Population. Only those participants with data available at the indicated time point were analyzed.||Participants|||Count of Participants
758071|NCT00612456|Secondary|Number of Participants With Change in Retinal Morphology (Cystoid Spaces, Subretinal Fluid and Retinal Pigment Epithelial Detachment) as Determined by OCT|OCT was used for the determination of retinal morphology changes in the study eye which included assessments of cystoids spaces (cyst like spaces in the inner layers of the retina), subretinal fluid (an exudate between the retina and choroid from various sources including the vitreous cavity, subarachnoid space, or abnormal vessels) and pigment epithelial detachment (retinal pigment epithelium separates from the underlying Bruch's membrane due to the presence of blood, serous exudate, drusen, or a neovascular membrane). Data has been presented for number of participants with retinal morphology changes in the study eye at Day 29.|Day 29|PD Parameter Population. Only those participants with data available at the indicated time point were analyzed.||Participants|||Count of Participants
758072|NCT00612456|Secondary|Change From Baseline in Best Corrected Visual Acuity (BCVA) [Number of Letter Read on Standardized Early Treatment of Diabetic Retinopathy Study (ETDRS) Charts at Day 29|BCVA was measured in the study eye using the ETDRS visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the participant. A decrease in the BCVA score indicates a worsening of vision while higher scores indicates improvement of VA. Analyses of change from baseline in BCVA at Day 29 were done for two sub-efficacy-populations. One sub-efficacy population included all participants in the efficacy population with a YES for retinal angiomatous proliferation (RAP)/retinal choroidal anastomosis (RCA) NONE field from Digital angiography reading center (DARC) FA form in study eye. The other included all participants in the efficacy population with a YES for eligible field from DARC FA form in study eye. Baseline was defined as the assessments performed between Day -3 to -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-randomization value at Day 29.|Baseline (Day -3 to -1) and Day 29|Efficacy population comprised of all participants in the Safety Population who completed at least 7 days of pazopanib eye drop treatment and provided VA measurements and had CNV present as detected by FA. Only those participants available at the specified time points were included for analysis.||Score on scale||Standard Deviation|Mean
758073|NCT00612456|Secondary|Number of Participants With Ocular Adverse Events, Non-ocular Adverse Events, Serious Ocular Adverse Events and Serious Non-ocular Adverse Events|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury. Data has been presented for number of participants with ocular and non-ocular adverse events and serious adverse event|Up to follow-up (Day 43)|Safety population||Participants|||Count of Participants
758074|NCT00612456|Secondary|Number of Participants With Abnormal Urinalysis Data by Dipstick Analysis|Urinalysis included analysis for urine occult blood, urine glucose, urine ketones and urine proteins via dipstick analysis. Data has been presented for number of participants with abnormal urinalysis results. Only categories with values have been presented.|Day 29 and follow-up (Day 43)|Safety population. Only those participants available at the specified time points were analyzed.||Participants|||Count of Participants
758075|NCT00612456|Secondary|Number of Participants With Clinical Chemistry and Hematology Data of Potential Clinical Concern|Clinical chemistry parameters assessed included blood urea nitrogen, potassium, calcium, albumin, creatinine, chloride, sodium, total protein, glucose, total carbon dioxide, aspartate amino transferase, alanine amino transferase, direct bilirubin, total bilirubin, alkaline phosphatase and hematology parameters assessed included platelet count, white blood cell count, red blood cell count, reticulocyte count, hemoglobin, mean corpuscle volume, mean corpuscle hemoglobin, mean corpuscle hemoglobin concentration, total neutrophils, lymphocytes, monocytes, eosinophils, basophils. Data has been presented for the number of participants with values high and low of potential clinical concern for clinical chemistry and hematology.|Up to follow-up Day 43|Safety population.||Participants|||Count of Participants
758076|NCT00612456|Secondary|Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings|Single 12-lead ECGs were to be obtained at each Day 15 and follow-up Day 43 using an ECG machine that automatically calculated the heart rate and measures PR, QRS, QT, and QTc intervals. ECG findings were defined as abnormal-not clinically significant (A-NCS) and abnormal-clinically significant (A-CS). Data has been presented for the number of participants with A-NCS and A-CS findings.|Day 15 and follow-up (Day 43)|Safety population. Only those participants available at the specified time points were analyzed.||Participants|||Count of Participants
758077|NCT00612456|Secondary|Number of Participants With Vital Sign Data for Systolic Blood Pressure and Diastolic Blood Pressure and Heart Rate of Potential Clinical Concern|Vital sign assessments included systolic blood pressure, diastolic blood pressure and heart rate. The potential clinical concern range for systolic blood pressure was <85 and > 160 millimeters of mercury, diastolic blood pressure <45 and > 100 millimeters of mercury, heart rate <40 and >110 beats per minute. Only those parameters for which at least one value of potential clinical importance was reported are summarized. The number of participants with potential clinical important findings at any visit were reported.|Up to follow up (Day 46)|Safety population.||Participants|||Count of Participants
758078|NCT00612456|Secondary|Number of Participants With Complete Ophthalmic Examination Values of Potential Clinical Concern|A complete eye examination was performed to include the following: Examination of eyelids and lashes (including meibomian glands), Pupil, motility and confrontation visual field examination, Slit lamp evaluation of anterior ocular structures (including conjunctiva, tear film, cornea with fluorescein staining, anterior chamber, iris, lens, and anterior vitreous), intraocular pressure (IOP) measurement and Dilated Fundus Examination (Indirect ophthalmoscopy and slit lamp biomicroscopy). Data has been presented in a consolidated format for the total number of participants with values of potential clinical concern for complete ophthalmic examinations until Day 43.|Upto follow-up (Day 43)|Safety population comprised of all participants who received at least one dose of investigational product.||Participants|||Count of Participants
758079|NCT00612456|Primary|Mean Change From Baseline in Central Retinal/Lesion Thickness (CRLT) as Measured by the Carl Zeiss Meditec Stratus Optical Coherence Tomography (OCT) Scanner at Day 29|CRLT was measured by the Carl Zeiss Meditec Stratus OCT scanner based on the manual measurement of the distance between the inner and outer retina, inclusive of subretinal fluid and any choroidal neovascularization (CNV) as measured in the central 1 millimeter (mm) area of the 7 mm Posterior Pole Scan. OCT scans/images were collected by trained and certified photographer and analyzed by investigator. Two datasets were used for analysis namely Last observation carried forward (LOCF) which included missing assessment for a participant who completed at least 7 days of pazopanib eye drop replaced by the last non-missing assessment post 7 days of pazopanib eye drop treatment. OC dataset included a missing assessment at any scheduled time was considered unevaluable and was not imputed. Baseline was defined as the assessments performed between Day -3 to -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-randomization value at Day 29.|Baseline (Day -3 to -1) and Day 29|Pharmacodynamics (PD) parameters population comprised of all participants in the Safety Population and had Choroidal Neovascularization (CNV) present as detected by Fluorescein Angiography (FA). LOCF and OC dataset were used for analysis. Only those participants with data available at the indicated time point were included for analysis.||Microns||Standard Deviation|Mean
758080|NCT00612508|Secondary|Adverse Events|Self-reported treatment-related and serious adverse events|over 168 days|All subjects that were enrolled were assessed for adverse events at each study visit. Measure is number of participants with event||participants|||Number
758081|NCT00612508|Primary|Thickness of the Vaginal Epithelium (in mm)With Means and Standard Deviations Reported.|Histologic evalation of vaginal sections was performed to measured and record the absolute thickness of the vaginal epithelium. Baseline findings were compared to biopsies after three and six cycles of treatment. Mean values were compared using T-test for paired data for baseline and 84 days, and baseline and 168 days|baseline, 84 days, 168 days|"A total of 14 subjects (7 R, 7 P) were randomized and had an initial biopsy; 11 (6 R, 5 P) returned for a biopsy at 3rd cycle (84 days), and 6 (3 R, 4 P) 6th cycle (168 days).
The analysis used a paired T test comparing the baseline mean to the mean as the end of the 3rd cylce (e.g. 84 days) and the 6th cycle (168 days)"||mm||Standard Deviation|Mean
758082|NCT00612534|Primary|SPID-12|SPID-12 is the sum of the pain intensity difference (PID) over the 12 hour time period. A pain intensity score of 0 (no pain) to 10 (worst possible pain) is obtained before starting the study and throughout the 12 hour time period. The pain score at each assessment time point is subtracted from the baseline pain score (starting point) to provide the total sum score or SPID-12. A higher SPID-12 score is better and indicates a reduction in pain intensity compared to the baseline score. Per protocol, pain scores are collected at 15 different time points. If all scores are collected, the full range of SPID-12 scores could be -150 to 150.|12 hours after first dose|One patient in Sufentanil NanoTab 10 mcg group received the incorrect treatment so was not included in efficacy analysis||units on a scale||Standard Error|Least Squares Mean
758089|NCT00612573|Primary|Absolute Change in Inflammatory Lesion Count From Baseline to Week 12, ITT Population|Change derived as Baseline evaluation minus the Week 12 evaluation. Thus a positive change reflects a reduction in lesion count. Inflammatory Lesion Count includes nodules, papules and pustules.|Baseline to Week 12|ITT Population||Lesions||Standard Deviation|Mean
758090|NCT00612573|Primary|Percentage Patients With Successful Outcome Investigator's Global Assessment (IGA) Score at Week 12, Intent to Treat (ITT) Population|IGA: 0/clear (clear skin no lesions, inflammatory or non-inflammatory), 1/almost clear (rare non-inflammatory lesion w/no more than 1 small inflammatory lesion), 2/mild (some non-inflammatory lesions with no more than a few inflammatory lesions, papules/pustules only, no nodular lesions), 3/moderate (up to many non-inflammatory lesions, some inflammatory lesions, no more than 1 small nodular lesion), 4/severe (many non-inflammatory & inflammatory lesions, no more than a few nodular lesions. Lower score improvement in score. Success=IGA decrease of at least 2 grades from baseline score.|Week 12|ITT Population||Percentage of Participants||95% Confidence Interval|Number
758091|NCT00612677|Secondary|Number of Participants Who Experienced Toxicities|We planned to determine the safety of the regimen (Drug Toxicities) assessed by NCI Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0)|Patient will continue study treatment until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay > 3 weeks.|Study closed before treatment started.|||||
758092|NCT00612677|Secondary|Time to Progression (TTP)|We planned to calculate the median Time to Progression of all participants.|Patient will continue study treatment until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay > 3 weeks.|Study closed before treatment started.|||||
758093|NCT00612677|Primary|Number of Patients Who Responded to Treatment|We planned to determine the Overall Response Rate (ORR = CR+PR) of this regimen according to RECIST Criteria.|Patient will continue study treatment until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay > 3 weeks.|Study closed before treatment started.|||||
758094|NCT00612690|Secondary|The Academic Competence Evaluation Scale (ACES)|The ACES is a teacher rating scale that describes a set of behaviors and attitudes measuring teachers’ perceptions of student's academic competence and performance. The scale consists of 30 items rated on a 5-point scale (1 = Never, 2 = Seldom, 3 = Sometimes, 4 = Often, 5 = Almost Always). The total score was reported as a mean per item with higher scores indicating better academic competence. Scores could range from 1 to 30.|Measured at pre- and post-school year for 3 years|Only children with available data were included in the analyses.||units on a scale||Standard Deviation|Mean
758095|NCT00612690|Primary|Social Skills Rating System (Parent Report)|This rating scale was completed by parents to assess how frequently their child engaged in a range of disruptive, prosocial, and academic behaviors (0 = Never to 2 = Very Often). Normative data are provided by age and sex and the measure was standardized on a heterogeneous population of which one third were urban and 28% were minorities. The scale score, Social Skills, was the primary outcome measure. Scores are rated on a scale of 0 (Never) to 2 (Very Often). The scale score, Social Skills, containing 38 items, was the primary outcome measure. Scores range from 0 to 76 with higher scores indicating improved social skills.|Measured at pre- and post-school year for 3 years|Child participants with available data were included.||units on a scale||Standard Deviation|Mean
758096|NCT00612807|Secondary|Beck Anxiety Inventory||pre-treatment, post-treatment, 6 month follow-up||||||
758097|NCT00612807|Secondary|Personal Assessment of Intimacy in Relationships||pre-treatment, post-treatment, 6 month-followup||||||
758098|NCT00612807|Secondary|SCID Mood Disorders||pre-treatment, post-treatment, 6 month follow-up||||||
758099|NCT00612807|Secondary|Conflict Tactics Scale||pre-treatment, post-treatment, 6 month follow-up||||||
758100|NCT00612807|Secondary|Frequency & Acceptability of Partner Behavior||Pre-treatment, post-treatment, 6 month follow-up||||||
758101|NCT00612807|Primary|Dyadic Adjustment Scale (DAS)|The DAS is a self-report measure of marital adjustment that includes questions about agreement on lifestyle and household decisions, level of conflict, level of cooperation, and affection. Scores range from 0 to 151, with higher scores representing better relationship functioning.|pre-treatment, monthly, post-treatment, 6 month follow-up|||Score on DAS measure||Standard Deviation|Mean
758102|NCT00612807|Primary|Hamilton Depression Rating Scale (HDRS)|The HDRS is a semi-structured interview administered by a trained independent evaluator, and used for rating the severity of depressive symptoms. Scores range from 0 to 50, with higher scores indicating greater severity of depression.|pre-treatment, monthly, post-treatment, 6 month follow-up|||Score on HDRS||Standard Deviation|Mean
758745|NCT00618748|Secondary|Change From Baseline in Glucose and Lipid Panel at Week 24 or Week 48 Endpoint||baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)|Participants with non-missing baseline value and the specified visit result.||millimole/Liter||Standard Deviation|Mean
758106|NCT00613015|Secondary|Cortisol- 2:30 pm, Immediately Following Trier Social Stress Task + Cocaine Cue Exposure|Participants were randomized to receive to the modafinil, guanfacine, or placebo treatment group. Participants were then randomized to complete a TRIER social stress task or read magazines for 15 minutes. Following the task, participants were exposed to neutral cues for two minutes and control cues for two minutes. Immediately following exposure to the cocaine cue, saliva samples were collected to measure cortisol levels.|Immediately following trier + cocaine cue exposure|||mcg/dl||Standard Deviation|Mean
758107|NCT00613015|Primary|Cocaine Craving- 2:30 pm, Immediately Following Trier + Cocaine Cue Exposure|Participants were randomized to the modafinil, guanfacine, or placebo treatment group. Participants were then randomized to participate in the TRIER social stress task or to read magazines for 15 minutes. Following the task, participants were exposed to neutral cues for 2 minutes and cocaine cues for 2 minutes. Immediately following the cocaine cue exposure, participants were asked to rate cocaine craving on a 10-point Likert scale, with 0 being Not at All and 10 being Extremely.|Post Trier social stress task + Cocaine Cue|||units on a scale||Standard Deviation|Mean
758108|NCT00613028|Secondary|Grade 3 or Greater, Treatment Related, Non-hematologic Toxicities.|Incidence of ≥Grade 3 treatment related, non-hematologic toxicity|41 months|||participants|||Number
758109|NCT00613028|Secondary|Median Overall Survival (OS)|Time in months from the start of study treatment to date of death due to any cause. Patients alive as of the last follow-up had OS censored at the last follow-up date. Median OS was estimated using a Kaplan-Meier curve.|41 months|||weeks||95% Confidence Interval|Median
758110|NCT00613028|Secondary|Median Progression-free Survival (PFS)|Time in months from the start of study treatment to the date of first progression according to Macdonald criteria, or to death due to any cause. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve.|41 months|||weeks||95% Confidence Interval|Median
758111|NCT00613028|Secondary|Radiographic Response|Percentage of participants with an objective response (complete response or partial response) based on modified Macdonald criteria.|41 months|||percentage of participants|||Number
758112|NCT00613028|Primary|The Primary Outcome Measure is 6 Month Progression-free Survival.|Percentage of participants surviving six months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to the Macdonald criteria, or to death due to any cause.|6 months|||percentage of participants||95% Confidence Interval|Number
758113|NCT00613080|Secondary|Rate of Anterior Posterior Resections||From registration to end of follow-up||||||
758114|NCT00613080|Secondary|Patterns of Failure (i.e., Local, Regional, and Distant), Including Overall Survival (Death Due to Any Cause)||From registration to date of local failure, regional failure, distant failure, death or last follow-up||||||
758115|NCT00613080|Secondary|All Treatment-related Adverse Events Per NCI CTCAE v3.0 Preoperative, Postoperative, and Overall||Three timeframes: Start of treatment to surgery, Surgery to 3 months after the completion of postoperative chemotherapy and Combined||||||
758116|NCT00613080|Secondary|Pathologic Complete Response Rate||After protocol surgery||||||
758117|NCT00613080|Secondary|Intensity-modulated Radiotherapy (IMRT) Feasibility||IMRT planning and dosing data is centrally reviewed for quality assurance||||||
758118|NCT00613080|Primary|The Percentage of Patients Experiencing Treatment-related Gastrointestinal Adverse Events ≥ Grade 2 Per National Cancer Institute (NCI) Common Terminology Critereia for Adverse Events (CTCAE) v. 3.0, Occurring Preoperatively|The percentage of patients experiencing preoperative treatment-related gastrointestinal adverse events ≥ grade 2. If patient did not receive surgery, then such adverse events <= 90 days from the start of concurrent treatment are included.|From start of treatment to surgery or ≤ 90 days from the Start of Concurrent Treatment (for patients not undergoing surgery)|Eligible subjects who started study treatment.||percentage of patients||90% Confidence Interval|Number
758119|NCT00613106|Primary|Number of Participants With Treatment Emergent Adverse Events|"The objective of this study was to evaluate the long term safety of HZT-501 (ibuprofen 800 mg/famotidine 26.6 mg). No efficacy analyses were planned or performed. Adverse event information was elicited from each participant by indirect questioning using a non-leading question, such as Has anything bothered you since your last visit or is anything bothering you now? Adverse event data may also have been volunteered by the participant to the investigator or designee. Physicians assessed the seriousness, severity and causality of each adverse event."|28 weeks|||participants|||Number
758120|NCT00613301|Secondary|Change From Baseline in Modified Hoehn & Yahr Rating Scale|A severity of PD symptom are assessed by Modified Hoehn & Yahr rating scale. This scale consist of 10 levels including additional evaluation levels defined in Japan. Ten levels are described by 0 (best), 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5 (worst).|Baseline and at 36 months (or at the time of discontinuation)|The number of patients (295) means a population who have the assessment of Modified Hoehn & Yahr rating scale at baseline and at least one post-visit after administration of pramipexole.||Unit on a scale||Standard Deviation|Mean
758121|NCT00613301|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score|Motor examination is assessed by 27 questionnaire items in UPDRS Part III section. Each item is scored from 0 (best) to 4 (worst), and the total score of UPDRS Part III is from 0 (best) to 108 (worst). A decrease in the score means improvement.|Baseline and at 36 months (or at the time of discontinuation)|The number of patients (291) means a population who have the assessment of UPDRS Part III total score at baseline and at least one post-visit after administration of pramipexole.||Unit on a scale||Standard Deviation|Mean
758122|NCT00613301|Secondary|Clinical Global Impression of Improvement|Investigators evaluation of the PD symptoms on a rating scale of 5 categories (very much improved, much improved, minimally improved, no effect, and unassessable).|after 36 months treatment|There were 346 patients in the safety analysis set. Patients excluded from this population: 5 because of administration to patients who didn’t suffer from PD and 2 with no efficacy data available. As a result, 339 patients were evaluated for efficacy.||Participants|||Number
758154|NCT00613509|Primary|Progression-Free Survival Time by Response Evaluation Criteria in Solid Tumor (RECIST) Criteria in the Intent-to-treat Population|Progression-Free Survival was assessed by the Response Evaluation Criteria in Solid Tumor criteria from the computed tomography (CT) scans, as per-protocol|Day 0 - up to 35 weeks post 1st vaccination or treatment|The Progression-Free Survival Time were assessed in the intend-to-treat (ITT) evaluable population.||Weeks||Inter-Quartile Range|Median
758123|NCT00613301|Primary|Proportion of Adverse Events, Adverse Drug Reactions, Serious Adverse Events|The aim of this Post Marketing Surveillance (PMS) was to obtain safety data in Parkinson's disease (PD) patients without concomitant use of levodopa for 3 years.|during 36 months|364 patients had available case report forms. Patients excluded: 5 patients with no visit since the first prescription, 12 irregularly enrolled patients, 9 excluded from analysis according to regulatory requirement, and 1 patient with no safety data available. As a result, there were 346 patients in the safety analysis set.||Proportion (percentage of participants)|||Number
758124|NCT00613314|Secondary|Percentage of Patients With Presence of Metabolic Risk Factor|"Presence of metabolic risk factor was identified by the existence of 3 out of the 5 risk factors namely:
a.) presence of diabetes mellitus; b) presence of dyslipidemia; c) presence of albuminuria; d) presence of ventricular hypertrophy; and e) presence of co-morbidities,
based on patients’ Medical History"|At the end of 60 day period|ITT Population: all patients who took at least one dose of the study medication and have at least one point treatment efficacy data available||Percentage of patients|||Number
758125|NCT00613314|Primary|Change in Diastolic Blood Pressure (DBP) From Baseline|Change in DBP = Value in visit 1(baseline) minus value in visit 3 (at 60-day treatment period)|Baseline and 60 days|ITT Population: all patients who took at least one dose of the study medication and have at least one point treatment efficacy data available||mmHg||Standard Deviation|Mean
758126|NCT00613314|Primary|Change in Systolic Blood Pressure (SBP) From Baseline|Change in SBP = Value in visit 1(baseline) minus value in visit 3 (at 60-day treatment period)|Baseline and 60 days|ITT Population: all patients who took at least one dose of the study medication and have at least one point treatment efficacy data available||mmHg||Standard Deviation|Mean
758127|NCT00613314|Primary|Response Rate at the End of 60 Day Period|"Response rate on Blood Pressure:
Sitting SBP < 130 mmHg and/or a reduction of > 20 mmHg from baseline.
Sitting DBP < 85 mmHg and/or a reduction of > 10 mmHg from baseline.
Sitting BP normalization < 130 mmHg and DBP < 85 mmHg"|At the end of 60 day period|ITT Population: all patients who took at least one dose of the study medication and have at least one point treatment efficacy data available||Percentage of patients|||Number
758128|NCT00613314|Primary|Response Rate at the End of 30 Day Period|"Response rate of Blood Pressure assessed in the following categories:
Sitting SBP < 130 mmHg and/or a reduction of > 20 mmHg from baseline
Sitting DBP < 85 mmHg and/or a reduction of > 10 mmHg from baseline Sitting BP normalization < 130 mmHg and DBP < 85 mmHg"|End of 30 day Period|ITT Population: all patients who took at least one dose of the study medication and have at least one point treatment efficacy data available||Percentage of patients|||Number
758129|NCT00613327|Secondary|Percent Change From Baseline in Visual Analogue Scale (VAS) Score for Dry Mouth at Week 6 and 12|Severity of dry mouth was evaluated in participants by using VAS: how much dry mouth they experienced in the past one week. The total score range was 0 (no dry mouth) to 100 (unimaginably most severe dry mouth). Percent change was calculated as (change value/Baseline value)*100.|Baseline, Week 6, 12 or ED|ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure and 'n' specifies those participants who were evaluable for specific categories.||Percent change||Standard Deviation|Mean
758130|NCT00613327|Secondary|Visual Analogue Scale (VAS) Score for Dry Mouth|Severity of dry mouth was evaluated in participants by using VAS: how much dry mouth they have experienced in the past one week. The total score range was 0 (no dry mouth) to 100 (unimaginably most severe dry mouth).|Baseline, Week 6, 12 or ED|ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure and 'n' specifies those participants who were evaluable for specific categories.||Units on a scale||Standard Deviation|Mean
758131|NCT00613327|Secondary|Mean Severity of Urinary Urgency at Urination|Urinary urgency means sudden and strong urge to urinate. It was rated by participant on 5-point scale (1=no urinary urgency, 2=light urinary urgency, 3=moderate urinary urgency, 4=severe urinary urgency and 5=urge urinary incontinence). Mean severity of urinary urgency at urination was calculated as sum of all degrees of urinary urgency measured divided by the voiding frequency.|Baseline, Week 6, 12 or ED|Data was reported in individual participant listings as planned, but not statistically summarized for analysis.|||||
758132|NCT00613327|Secondary|Percent Change From Baseline in Frequency of Urinary Urgency and Urinary Incontinence at Week 6 and 12|Urinary urgency means sudden and strong urge to urinate. It was rated by participant on 5-point scale (1=no urinary urgency and 5=urge urinary incontinence). Total frequency of UI for 24 hours was calculated as sum of total frequency of incontinence divided by the number of days when micturition chart was completed. Participants completed micturition chart for 3 days at Baseline, Week 6 and 12/ED. Mean frequency of urinary urgency for 24 hours was calculated as sum of total frequency of urinary urgency divided by the number of days when micturition chart was completed. Urinary urgency was defined as voiding with urinary sensation scale score greater than or equal to 3. Percent change was calculated as (change value/Baseline value)*100.|Baseline, Week 6, 12 or ED|ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here, 'n' specifies those participants who were evaluable for specific categories.||Percent change||Standard Deviation|Mean
758133|NCT00613327|Secondary|Frequency of Urinary Urgency and Urinary Incontinence|Urinary urgency means sudden and strong urge to urinate. It was rated by participant on 5-point scale (1=no urinary urgency and 5=urge urinary incontinence). Total frequency of urinary incontinence (UI) for 24 hours was calculated as sum of total frequency of incontinence divided by the number of days when micturition chart was completed. Participants completed micturition chart for 3 days at Baseline, Week 6 and 12/ED. Mean frequency of urinary urgency for 24 hours was calculated as sum of total frequency of urinary urgency divided by the number of days when micturition chart was completed. Urinary urgency was defined as voiding with urinary sensation scale score greater than or equal to 3.|Baseline, Week 6, 12 or ED|ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here, 'n' specifies those participants who were evaluable for specific categories.||Episodes per day||Standard Deviation|Mean
760264|NCT00634088|Secondary|Maximum Concentration of Ixabepilone||Day 1 of 21-day cycle|Participants who received ixabepilone with lapatinib treatment and had pharmacokinetic parameters available.||ng/mL||Standard Deviation|Geometric Mean
758134|NCT00613327|Secondary|Percent Change From Baseline in Mean Voiding Frequency at Week 6 and 12|Mean voiding frequency for 24 hours was calculated as sum of total voiding frequency divided by the number of days when micturition chart was completed. Participants completed micturition chart for 3 days at Baseline, Week 6 and 12/ED. Mean daytime voiding frequency for 24 hours was calculated as sum of total daytime voiding frequency divided by the number of days when micturition chart was completed. Mean nighttime voiding frequency for 24 hours was calculated as sum of total nighttime voiding frequency divided by the number of days when micturition chart was completed. Nighttime voiding was defined as voiding during the sleep cycle. Percent change was calculated as (change value/Baseline value)*100.|Baseline, Week 6, 12 or ED|ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here, 'n' specifies those participants who were evaluable for specific categories.||Percent change||Standard Deviation|Mean
758135|NCT00613327|Secondary|Mean Voiding Frequency|Mean voiding frequency for 24 hours was calculated as sum of total voiding frequency divided by the number of days when micturition chart was completed. Participants completed micturition chart for 3 days at Baseline, Week 6 and 12/ED. Mean daytime voiding frequency for 24 hours was calculated as sum of total daytime voiding frequency divided by the number of days when micturition chart was completed. Mean nighttime voiding frequency for 24 hours was calculated as sum of total nighttime voiding frequency divided by the number of days when micturition chart was completed. Nighttime voiding was defined as voiding during the sleep cycle.|Baseline, Week 6, 12 or ED|ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here, 'n' specifies those participants who were evaluable for specific categories.||Urinations per day||Standard Deviation|Mean
758136|NCT00613327|Secondary|Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Score at Week 6 and 12|The OAB-q was used to evaluate influence of overactive bladder symptom on health-related quality of life (HRQL). It consisted of 2 parts: Symptom bother (6 items) evaluating how much symptoms related to overactive bladder were bothering in the last 4 weeks and HRQL (13 items) evaluating how general symptoms related to the bladder influenced life in the last 4 weeks. Each item was rated on 6-point Likert scale: 1 (not at all) to 6 (a very great deal). Total score range: 6 to 36 for symptom bother and 13 to 78 for HRQL. Transformed score calculated as ([Actual total raw score – lowest possible value of raw score]/range)*100 for symptom bother where higher score indicates greater symptom bother and as ([Highest possible raw score-Actual total raw score]/Raw score range)*100 for HRQL where higher scores indicate better HRQL. Transformed score range: 0-100 for both, symptom bother and HRQL.|Baseline, Week 6, 12 or early discontinuation (ED)|ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here, 'n' specifies those participants who were evaluable for specific categories at given time point.||Units on a scale||Standard Deviation|Mean
758137|NCT00613327|Secondary|Number of Participants With Response to Patient’s Perception of Bladder Condition (PPBC) Questionnaire|"Participant’s perception about bladder condition was evaluated by using self administered PPBC questionnaire. Participants answered “Which of the following statements describes your bladder condition best at the moment? on a 6-point scale: 1= not problematic at all, 2=mild problem, 3=more or less a mild problem, 4=moderate problem, 5=severe problem and 6=very severe problem."|Baseline and Week 12|ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here, 'n' specifies those participants who were evaluable for specific categories at given time point.||Participants|||Number
758138|NCT00613327|Secondary|Number of Participants With Response to Patient’s Perception of Treatment Benefit (PPTB) Questionnaire|The PPTB was used to assess participant’s perception about treatment benefit and satisfaction of the study drug. Regarding benefit, participants indicated whether they had any benefit obtained from the treatment. If yes, then the participants indicated whether it was weak benefit or strong benefit. Regarding satisfaction, participants indicated whether they were satisfied with the treatment. If yes, then they indicated if the treatment was slightly satisfactory or very satisfactory. If no, then they indicated if the treatment was slightly unsatisfactory or very unsatisfactory.|Week 2, 4, 6 and 12|ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure and 'n' specifies those participants who were evaluable for specific categories.||Participants|||Number
758139|NCT00613327|Secondary|Patient’s Perception of Symptom Improvement (PPSI) Score for Overactive Bladder|Participant’s perception about decrease in the most bothering symptom of overactive bladder (defined at Baseline) was evaluated by using visual analogue scale (VAS) at Week 12. The total score range was 0 to 100 where 0=symptom disappeared and 100=symptom unchanged or worsened compared to Baseline.|Week 12|ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||Units on a scale||Standard Deviation|Mean
758140|NCT00613327|Secondary|Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urge Urinary Incontinence at Week 12|Participants assessed their bothering for overactive bladder symptom by completing POSQ rated on a 5-point scale: how much they were bothered by urge urinary incontinence (involuntary voiding or urinary leakage due to sudden micturition desire, not by sneezing, coughing or laughing) in the past two weeks. The responses were indicated as: 1 (not bothered at all), 2 (slightly bothered), 3 (average), 4 (strongly bothered) and 5 (very strongly bothered). Number of participants with change from Baseline in the response to this question at Week 12 was reported.|Baseline and Week 12|ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||Participants|||Number
758155|NCT00613509|Other Pre-specified|Summary of Cellular Immune Response to the Vaccination or Treatment (Percent Regulatory T-Cells Responses)|The immunogenicity of the treatment regimens was assessed by regulatory T-cell responses as assessed primarily by the multi-parametric intracellular cytokine staining (ICS) assay.|Day 0 to 32 weeks post 1st vaccination or treatment|Immunologic responses were assessed in the per-protocol evaluable population.||Percent Cell Count||Standard Deviation|Mean
758141|NCT00613327|Secondary|Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Nighttime Urination at Week 12|Participants assessed their bothering for overactive bladder symptom by completing POSQ rated on a 5-point scale: how much they were bothered by nighttime frequent urination (waking up from sleep in order to void urine at nighttime [period from time of going to bed to time planned to wake up in the morning]) in the past two weeks. The responses were indicated as: 1 (not bothered at all), 2 (slightly bothered), 3 (average), 4 (strongly bothered) and 5 (very strongly bothered). Number of participants with change from Baseline in the response to this question at Week 12 was reported.|Baseline and Week 12|ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||Participants|||Number
758142|NCT00613327|Secondary|Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Daytime Urination at Week 12|Participants assessed their bothering for overactive bladder symptom by completing POSQ rated on a 5-point scale: how much they were bothered by daytime frequent urination (frequent urination was required more than the frequency desired during daytime) in the past two weeks. The responses were indicated as: 1 (not bothered at all), 2 (slightly bothered), 3 (average), 4 (strongly bothered) and 5 (very strongly bothered). Number of participants with change from Baseline in the response to this question at Week 12 was reported.|Baseline and Week 12|ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||Participants|||Number
758143|NCT00613327|Secondary|Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urinary Urgency at Week 12|Participants assessed their bothering for overactive bladder symptom by completing POSQ rated on a 5-point scale: how much they were bothered by urinary urgency (strong micturition desire indicated) in the past two weeks. The responses were indicated as: 1 (not bothered at all), 2 (slightly bothered), 3 (average), 4 (strongly bothered) and 5 (very strongly bothered). Number of participants with change from Baseline in the response to this question at Week 12 was reported.|Baseline and Week 12|ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||Participants|||Number
758144|NCT00613327|Primary|Percentage of Participants Who Achieved Treatment Goal|Goal achievement was measured by using the 6-point Likert scale (0=not achieved at all and 5=completely achieved). Achievement of treatment goal was defined by a score of 4 or 5 in the Likert scale. Percentage of participants who achieved their treatment goal defined at Baseline (for a maximum of 3 items among the 10 items including incontinence, urinary urgency, frequent urination, nocturnal frequent urination, tenesmus, general health, life habit, activity, pain/pressure pain, and sexual function) was reported.|Week 12|ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Missing data at Week 12 were imputed using last observation carried forward (LOCF).||Percentage of participants||95% Confidence Interval|Number
758145|NCT00613366|Secondary|Perceived Pain of IUD Insertion by Patient Using a 100mm Visual Analog Scale (VAS).|"Perceived pain measured using a 100mm visual analog scale (VAS).The 100mm Pain Visual Analog Scale (VAS) is an instrument used to capture subjective attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of pain by indicating a position along a 100mm continues line: pain scores can range from 0=No Pain (furthest point to the left) to 100=Worst Pain of My Life (furthest point to the right)."|At time of IUD insertion|ITT||mm||Standard Deviation|Mean
758146|NCT00613366|Primary|The Ease of IUD Insertion as Rated by the Provider Using a 100mm Visual Analog Scale (VAS).|"Provider ease of insertion was measured using a 100mm visual analog scale (VAS).The 100mm Pain Visual Analog Scale (VAS) is an instrument used to capture subjective attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of pain by indicating a position along a 100mm continues line: pain scores can range from 0=No Pain (furthest point to the left) to 100=Worst Pain of My Life (furthest point to the right)."|Time of IUD insertion|Intent to Treat (ITT)||mm||Standard Deviation|Mean
758147|NCT00613379|Primary|Maximum Change in Viral Load Following Initiation of Treatment.|The primary end point was the maximum change from baseline in viral load following initiation of treatment, defined as HIV-1 copies/mL, measured by the Roche Amplicor HIV-1 Monitor UltraSensitive™ Test (lower limit of detection [LLD] = 48 copies/mL).|59 days|All randomized subjects who received one dose of study drug were considered intent-to-treat (ITT) subjects and were analyzed for efficacy.||Log10copies HIV-1 RNA/mL||Standard Error|Mean
758148|NCT00613405|Secondary|Current Mood as Assessed by the Mood Form||~2 hours||||||
758149|NCT00613405|Secondary|Feelings of Stress/Anxiety as Measured by the State-Trait Inventory (STAI)||~2 hours||||||
758150|NCT00613405|Secondary|Physiological Assessments: Serum Cortisol, ACTH, BP, HR, and GSR||~ 2.5 hours (before, during and after exposure to stressor condition as well as exposure to neutral and marijuana-associated cues).||||||
758151|NCT00613405|Primary|Subjective Craving of Marijuana|Defined as the score on the Marijuana Craving Questionnaire (MCQ), range 7-84, higher scores indicate more craving|approx 2.5 hours (before, during and after exposure to stressor condition as well as exposure to neutral and marijuana-associated cues).|||Scores on a Scale||Standard Deviation|Mean
758152|NCT00613509|Secondary|Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term|"Common Terminology Criteria for Adverse Events (CTCAE) definitions:
Grade 3 is a severe adverse event; Grade 4 is a life-threatening or disabling adverse event."|Day 0 to 12 months post last vaccination|Safety assessments were conducted in the As-treated safety population.||Participants|||Number
758153|NCT00613509|Secondary|Best Overall Objective Response as Mean Duration of Response (Weeks) in the Intent-to-treat Population|Objective response rate (ORR) is the sum of complete response (CR) and partial response (PR) Complete response = Disappearance of all target lesions. Partial response = At least a 30% decrease in the sum of longest diameter of target lesions, taking as reference the baseline sum longest diameter.|Day 0 to 32 weeks post 1st vaccination or treatment|The best overall objective response as mean duration of response were assessed in the intent-to-treat (ITT) evaluable population.||Weeks||Full Range|Mean
758156|NCT00613509|Primary|Summary of Disease Progression in Study Participants, Intent-to-treat Population|Number of evaluable study participants who had died or experienced objective disease progression (no clinical objective response to treatment as evaluated by computed tomography [CT] scans or physical examination).|Day 0 up to 35 weeks post 1st vaccination or treatment|The Progression-Free Survival Time were assessed in the intend-to-treat (ITT) evaluable population.||Participants|||Number
758157|NCT00613509|Secondary|Best Overall Objective Response in the Intent-to-treat Population|Objective response rate (ORR) is the sum of complete response (CR) and partial response (PR) Complete response = Disappearance of all target lesions. Partial response = At least a 30% decrease in the sum of longest diameter of target lesions, taking as reference the baseline sum longest diameter.|Day 0 to 32 weeks post 1st vaccination or treatment|The best overall objective response were assessed in the intent-to-treat (ITT) evaluable population.||Percentage of participants|||Number
758158|NCT00613509|Secondary|Best Overall Objective Response as Number of Participants Responding in the Intent-to-treat Population|Objective response rate (ORR) is the sum of complete response (CR) and partial response (PR) Complete response = Disappearance of all target lesions. Partial response = At least a 30% decrease in the sum of longest diameter of target lesions, taking as reference the baseline sum longest diameter.|Day 0 to 32 weeks post 1st vaccination or treatment|The best overall objective response as number of participants responding was assessed in the intent-to-treat (ITT) evaluable population.||Particpants|||Number
758159|NCT00613509|Other Pre-specified|Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen|The Vaccine-induced increase of CD4 T-Cell positive response by antigen post-vaccination during the observation period compared to the screening values.|Day 0 to 32 weeks post 1st vaccination|Immunologic responses were assessed in the Per-protocol evaluable population.||Participants|||Number
758160|NCT00613509|Other Pre-specified|Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen|The vaccine-induced increase of CD8 T-Cell positive response by antigen post-vaccination during the observation period compared to the screening values.|Day 0 to 32 weeks post 1st vaccination|Immunologic responses were assessed in the Per-protocol evaluable population.||Participants|||Number
758161|NCT00613574|Secondary|Physicians Global Clinical Assessment of Tolerability at Final Visit by Severity, FAS|Physician Global Assessment of Spiriva® tolerability with a 4-point scale (1=excellent efficacy&tolerability, 4=poor) at end of the observation (Visit 3/week 8).|final visit (8 weeks)|Full Analysis Set (Intent-to-Treat population)||participants|||Number
758162|NCT00613574|Secondary|Physicians Global Clinical Assessment of Effect at Final Visit by Severity, FAS|Physician Global Assessment of Spiriva® efficacy with a 4-point scale (1=excellent efficacy&tolerability, 4=poor) at end of the observation (Visit 3/week 8).|final visit (8 weeks)|Full Analysis Set (Intent-to-Treat population)||participants|||Number
758163|NCT00613574|Secondary|Patients Global Clinical Assessment of Tolerability at Final Visit by Severity, FAS|Patient Global Assessment of Spiriva® tolerability with a 4-point scale (1=excellent efficacy&tolerability, 4=poor) at end of the observation (Visit 3/week 8).|final visit (8 weeks)|Full Analysis Set (Intent-to-Treat population)||participants|||Number
758164|NCT00613574|Secondary|Patients Global Clinical Assessment of Efficacy at Final Visit by Severity, Full Analysis Set (FAS)|Patient Global Assessment of Spiriva® efficacy with a 4-point scale (1=excellent efficacy&tolerability, 4=poor) at end of the observation (Visit 3/week 8).|final visit (8 weeks)|Full Analysis Set (Intent-to-Treat population)||participants|||Number
758165|NCT00613574|Secondary|Change From Baseline for Inspiratory Capacity (*Only Selected Sites) After 8 Weeks|Inspiratory capacity (IC) post-dose response at end of the observation (Visit 3/week 8) vs. baseline (Visit 1/week 0) at selected sites|Visit 1 to Visit 3 (baseline and 8 weeks)|Full Analysis Set (Intent-to-Treat population) and only patients from selected sites||liters||Standard Deviation|Mean
758166|NCT00613574|Secondary|Change From Baseline for Forced Vital Capacity After 8 Weeks|Forced vital capacity (FVC) post-dose response at end of the observation (Visit 3/week 8 ) vs. baseline (Visit 1/week 0)|baseline and final visit (8 weeks)|Full Analysis Set (Intent-to-Treat population)||liters||Standard Deviation|Mean
758167|NCT00613574|Primary|Change From Baseline in Post-dose Forced Expiratory Volume in 1 Second After 8 Weeks|Forced expiratory volume in 1 second (FEV1) post-dose response at the end of the observation (Visit 3/week 8) versus (vs.) baseline (Visit 1/week 0)|baseline and final visit (8 weeks)|Full Analysis Set (Intent-to-Treat population)||liters||Standard Deviation|Mean
758168|NCT00613626|Secondary|Assess VEGF Polymorphisms and Correlate Subject Response||24 months|This data was not collected for the safety lead-in participants.||probability|||Number
758169|NCT00613626|Secondary|Measure Overall Survival for Each Arm||24 months|||Months||95% Confidence Interval|Median
758170|NCT00613626|Secondary|Measure Disease Control Rate (CR + PR+ SD) in Each Arm|Response assessments completed per Response Evaluation Criteria In Solid Tumors Criteria (RECIST Therasse et al., 2000). Complete Response (CR) is defined as: Disappearance of all target lesions. Partial Response (PR) is defined as: >=30% decrease in the sum of the longest diameter of target lesions. Stable Disease (SD) is defined as: neither a partial response or progressive disease ( >=20% increase in the sum of the longest diameter of the target lesions).|24 months|12 participants were not analyzed due to missing data.||percentage of participants||95% Confidence Interval|Number
758171|NCT00613626|Secondary|Measure the Response Rate (CR + PR) in Each Arm|Response assessments completed per Response Evaluation Criteria In Solid Tumors Criteria (RECIST Therasse et al., 2000). Complete Response (CR) is defined as: Disappearance of all target lesions. Partial Response (PR) is defined as: >=30% decrease in the sum of the longest diameter of target lesions.|24 months|12 participants are excluded due to missing data.||percentage of participants||95% Confidence Interval|Number
758172|NCT00613626|Secondary|Percentage of Participants With Grade 3/4 Hematologic and Non-Hematologic Toxicities|Percentage of participants who experienced grade 3/4 hematologic and non-hematologic toxicities. Participants from Arm A were compared to subjects from Arm B + Safety Lead-In.|6 weeks (2 Cycles)|The participants from the safety run-in cohort were combined with the participants from ARM B for analysis of safety.||percentage of participants|||Number
758284|NCT00615992|Secondary|Global Assessment of Efficacy by Physician|Rating scale ranging from very good (best value) to not satisfactory (worst value)|Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)|The discrepancy between the total number of participants and the numbers analyzed for a certain parameter is due to missing data.||Participants|||Number
758173|NCT00613626|Primary|Time to Disease Progression - Median Time to Progression and Log-Rank Test|Kaplan-Meier analysis comparing arm A to arm B. Median time to progression and log-rank test. Safety lead-in participants are not included in this analysis per protocol.|24 months|Two participants from Arm A and Two Participants from Arm B were inevaluable for the time to disease progression analysis. (Reasons inevaluable include: toxicity and withdrawal of consent)||Months||95% Confidence Interval|Median
758174|NCT00606892|Secondary|Changes in Systolic and Diastolic Blood Pressure|The average peak change (change score = maximum post dose score minus predose baseline) in systolic and diastolic blood pressure after nicotine infusion.|30 minutes after each nicotine infusion|Changes in heart rate, systolic and diastolic blood pressure during the experimental sessions were analyzed on all subjects who completed both experimental sessions (n=12).||mm Hg||Standard Error|Mean
758175|NCT00606892|Secondary|Heart Rate|The average peak change (change score = maximum post dose score minus predose baseline) in heart rate was calculated.|30 minutes after each nicotine infusion|Changes in heart rate, systolic and diastolic blood pressure during the experimental sessions were analyzed on all subjects who completed both experimental sessions (n=12).||beats per minute||Standard Error|Mean
758176|NCT00606892|Primary|Subjective Responses to Intravenous Nicotine|"The Drug Effects Questionaire( DEQ) is a 7-item psychometric that measures the following subjective categories: 'drug strength',' high', 'feels stimulated', 'good effects', 'bad effects', 'head rush', and 'like the drug'. Smokers rated each item on a 100 millimeter scale from not at all (a score of 0) to extremely with a maximum score of 100."|30 minutes after each nicotine infusion|All participants who complete all interventions.||millimeters||Standard Error|Mean
758177|NCT00606892|Secondary|Cotinine Levels|Subject Cotinine Levels before each laboratory session.|Before each laboratory session on day 5|Subjects finishing the complete study. (n=12)||ng/mL||Standard Deviation|Mean
758178|NCT00606892|Secondary|Mean Reaction Time (RT) on Modified Stroop Task.|A Modified stroop task was used to assess attentional responses to smoking and negative affect cues. Cues were presented as blue, red or green text. Subjects completed 2 counterbalanced blocks (60 trials per block). One block contained smoking cues and neutral cues. The other block contained negative affect cues and a different set of matched neutral cues. The 2 blocks were administered twice during each experimental session - prior to nicotine infusion, and 30 mins after the last nicotine infusion (2 hrs and 45 mins after medication dosing). The Stroop effect is a differential RT when identifying the colors of words presented as neutral cues vs. emotional cues (i.e. smoking or negative affect cues).|pre-nicotine, and 30 min after last nicotine infusion (Post-Nicotine)|Data from all subjects who completed both experimental sessions (nicotine infusion after 4 days of placebo and also 4 days of varneicline, n=12) are presented. RT's < 100 ms, or > 1501 ms were excluded from the analysis (>3 SD's of the mean). The data presented are the mean RT's to identifying word colors under each treatment condition.||milliseconds||Standard Deviation|Mean
758179|NCT00606905|Primary|Number of Successful Pregnancies Defined as an Ongoing Pregnancy Over 20 Weeks Gestation, Per Number of Index Pregnancies||20 weeks gestation|47 women who achieved an index pregnancy, defined as the first pregnancy in the study, unless it resulted in a noneuploid miscarriage, ectopic, molar pregnancy or genetic termination, were analyzed.||Successful pregnancies|||Number
758180|NCT00606931|Other Pre-specified|Number of Participants Who Tolerated the PET-Guided Biopsy Procedure|Participants who could tolerate the procedure and complete it. This was ascertained by patient feedback questionnaire asking for overall discomfort rating from 0 to 5, where 0 is no discomfort and 5 was assigned to acute discomfort that prevented subject from completing the procedure.|Within one week of completing PET-guided biopsy|||Participants|||Number
758181|NCT00606931|Secondary|Number of Participants Who Reported Serious Adverse Events After the PET-Guided Biopsy|"Serious Adverse Events are defined as events that
Are fatal or life-threatening
Require in-patient hospitalization or prolong hospitalization
Result in permanent or significant disability/incapacity
Result in congenital abnormality/birth defect"|Within one week of completing PET-guided biopsy|||Participants|||Number
758182|NCT00606931|Primary|Number of Lesions That Were Successfully Biopsied Using the PET-guided Biopsy Method.|"Success in completion of the PET guided biopsy of a suspicious lesion was determined by
Alteration in lesion morphology (no change in vs change in lesion morphology) after sampling AND/OR
Visualization of regions with high radioactive uptake within the biopsy specimen consistent with target lesion (focal uptake present vs absent)."|within two days of obtaining histopathology of the lesion biopsied|All participants who completed the PET-guided biopsy for a suspicious lesions. 24 lesions were biopsied in 19 participants||Number of lesions|||Number
758183|NCT00606944|Secondary|Postoperative Complication||at postoperative day 30||||||
758184|NCT00606944|Secondary|Quality of Life|measured by SF-36|at postoperative day 30||||||
758185|NCT00606944|Secondary|Pain|score measured by the Visual Analog Scale|at postoperative day 30||||||
758186|NCT00606944|Secondary|Readmission Rate||at postoperative day 30||||||
758187|NCT00606944|Primary|Recovery|"recovery criteria must include all of the following
Tolerance of consecutive 3 soft bland diet
Unassisted ambulation
No necessity of analgesics
Afebrile without major complication"|at discharge||||||
758188|NCT00606944|Primary|Postoperative Complication During the First Admission||at discharge||||||
758189|NCT00606944|Primary|Quality of Life|measured by SF-36|at discharge||||||
758190|NCT00606944|Primary|Pain|score measured by the Visual Analog Scale|at discharge||||||
758191|NCT00606944|Primary|the Length of Hospital Stay|"discharge criteria
Tolerance of consecutive 3 soft bland diet
Unassisted ambulation
No necessity of analgesics
Afebrile without major complication
Willing to discharge"|at discharge|1 mortality case was excluded for analysis in the ERP group||day||Inter-Quartile Range|Median
758192|NCT00607048|Secondary|Total and Neutralizing Human Antihuman Antibody (HAHA) Titer|HAHA assessed as an indicator of immunogenicity to CP-870893.|Schedule A Day 3 of each 21 Day Cycle, Schedule B Day 8 of each 21 Day Cycle: Pre-dose up to a maximum of 8 cycles (6 months)|Data was not summarized as Human antihuman responses to CP-870893 were all below the limit of quantitation (endpoint titer of 4.32).|||||
758285|NCT00615992|Secondary|Global Assessment of Tolerability by Patient|Rating scale ranging from very good (best value) to not satisfactory (worst value)|Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)|The discrepancy between the total number of participants and the numbers analyzed for a certain parameter is due to missing data.||Participants|||Number
758193|NCT00607048|Secondary|Change in Bone Marrow Derived Cells (B Cell) Surface Markers: Human Leukocyte Antigen (HLA-DR) PD0, PDmax|Assess activity of B cells in presence of CP-870893. HLA-DR is a component of the Major Histocompatibility Complex in humans and presents antigens for recognition by the immune system. Agents that engage CD40 have been reported to increase HLA-DR expression; increased HLA-DR expression may serve as a marker for CD40 binding by CP-870893. Positive values may indicate greater presence of cells associated with potential for antibody production. Percentage of cells reported as the mean of the pre-dose values and the mean of the maximum post-dose values to show change.|Schedule A Cycle 1 / Day 3 and Schedule B Cycle 1 / Day 8: predose, 6, 24, and 48 hours postdose|Biomarker data analysis set; N=Number of participants contributing to the mean.||percentage of cells||Standard Deviation|Mean
758194|NCT00607048|Secondary|Change in Bone Marrow Derived Cells (B Cell) Surface Markers: CD86 PD0, PDmax|Assess activity of B cells in presence of CP-870893. CD86 is a protein expressed on antigen-presenting cells and provides co-stimulatory signals for T cell (role in cell-modulated immunity) activation. Agents that engage CD40 have been reported to increase CD86 expression; increased CD86 expression may, therefore, serve as a marker for CD40 binding by CP-870893. Higher numbers may indicate potential for increased immune response. Percentage of cells reported as the mean of the pre-dose values and the mean of the maximum post-dose values to show change.|Schedule A Cycle 1 / Day 3 and Schedule B Cycle 1 / Day 8: predose, 6, 24, and 48 hours postdose|Biomarker data analysis set; N=Number of participants contributing to the mean.||percentage of cells||Standard Deviation|Mean
758195|NCT00607048|Secondary|Change in Bone Marrow Derived Cells (B Cell) Surface Markers: CD54 PD0, PDmax|Assess activity of B cells in presence of CP-870893. CD54 is an intercellular adhesion molecule. When activated, leukocytes bind to endothelial cells via CD54 and then transmigrate into tissues. Agents that engage CD40 have been reported to increase CD54 expression; increased CD54 expression may, therefore, serve as a marker for CD40 binding by CP-870893. Higher numbers may indicate potential for increased immune response. Percentage of cells reported as the mean of the pre-dose values and the mean of the maximum post-dose values to show change.|Schedule A Cycle 1 / Day 3 and Schedule B Cycle 1 / Day 8: predose, 6, 24, and 48 hours postdose|Biomarker data analysis set; N=Number of participants contributing to the mean.||percentage of cells||Standard Deviation|Mean
758196|NCT00607048|Secondary|Change in Bone Marrow Derived Cells (B Cell) Surface Markers: CD23 PD0, PDmax|Assess activity of B cells in the presence of CP-870893. CD23 is a low-affinity receptor that has a role in transportation in antibody feedback regulation. Agents that engage CD40 have been reported to increase CD23 expression; increased CD23 expression may, therefore, serve as a marker for CD40 binding by CP-870893. Higher numbers may indicate a potential for increased antibody response. Percentage of cells reported as the mean of the pre-dose values and the mean of the maximum post-dose values to show change.|Schedule A Cycle 1 / Day 3 and Schedule B Cycle 1 / Day 8: predose, 6, 24, and 48 hours postdose|Biomarker data analysis set; N=Number of participants contributing to the mean.||percentage of cells||Standard Deviation|Mean
758197|NCT00607048|Secondary|Change in Bone Marrow Derived Cells (B Cell) Surface Markers: CD40 PD0, PDmax|Assess activity of B cells in the presence of CP-870893. CD40 is a costimulatory protein and is a target for CP-870893. Measurement of CD40 on white blood cells provides a measure of target modulation by CP-870893. Higher numbers may indicate potential for increased activation of antigen presenting cells. Percentage of cells reported as the mean of the pre-dose values and the mean of the maximum post-dose values to show change.|Schedule A Cycle 1 / Day 3 and Schedule B Cycle 1 / Day 8: predose, 6, 24, and 48 hours postdose|Biomarker data analysis set; N=Number of participants contributing to the mean.||percentage of cells||Standard Deviation|Mean
758198|NCT00607048|Secondary|Change in Bone Marrow Derived Cells (B Cell) Surface Markers: CD19 Pre-dose Percentage (PD0), Maximum Post-dose Percentage (PDmax)|Assess activity of B cells (involved in production of antibodies) in presence of CP-870893. Clusters of differentiation (CD) are specific types of proteins on cell surface. CD19 is a B cell antigen receptor and is used to quantitate changes in proportion of B cells in peripheral blood as a consequence of therapy. Higher numbers may indicate a greater presence of CD19 on cell surface with increased potential for antigen response. Percentage of cells reported as the mean of the pre-dose values and the mean of the maximum post-dose values to show change.|Schedule A Cycle 1 / Day 3 and Schedule B Cycle 1 / Day 8: predose, 6, 24, and 48 hours postdose|Biomarker data analysis set: All enrolled participants who started treatment and who had baseline and sufficient on-study samples to provide interpretable results. N=Number of participants contributing to the mean.||percentage of cells||Standard Deviation|Mean
758199|NCT00607048|Secondary|Change in Cytokine Concentrations of Tumor Necrosis Factor Alpha (TNF Alpha): CYTO0, CYTOMAX|Concentrations reported as the mean of the pre-dose values and the mean of the maximum post-dose values to show change. An increase in values indicates greater cytokine release from cells targeted by the antibody and may be associated with an infusion reaction.|Schedule A Cycle 1 / Day 3 and Schedule B Cycle 1 / Day 8: predose, end of infusion, 1 , 2, 4, 6, 24, and 48 hours postdose|Pharmacokinetic data analysis set. CYTO0 values = the lower limit of quantitation (LLOQ).||pg/mL||Standard Deviation|Mean
758200|NCT00607048|Secondary|Change in Cytokine Concentrations of Interleukin 6 (IL 6): Pre-dose Concentration (CYTO0), Maximum Post-dose Concentration (CYTOMAX)|Concentrations reported as the mean of the pre-dose values and the mean of the maximum post-dose values to show change. An increase in values indicates greater cytokine release from cells targeted by the antibody and may be associated with an infusion reaction.|Schedule A Cycle 1 / Day 3 and Schedule B Cycle 1 / Day 8: predose, end of infusion, 1 , 2, 4, 6, 24, and 48 hours postdose|Pharmacokinetic data analysis set.||picograms per milliliter (pg/mL)||Standard Deviation|Mean
758201|NCT00607048|Secondary|Tumor Response of Partial Response (PR) and Complete Response CR) According to Response Evaluation Criteria in Solid Tumors (RECIST)|Number of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as the disappearance of all target and nontarget lesions. PR was defined as a ≥30% decrease in the sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD.|Schedule A and Schedule B: Baseline and Day 21 of every even numbered cycle up to a maximum of 8 cycles (6 months)|All response-evaluable population: included all participants who had measurable disease, a baseline tumor assessment and who started treatment were considered evaluable for analysis of tumor response.||participants|||Number
760302|NCT00634569|Secondary|Number of Adverse Events|Total Number of Adverse Events|12 months|||All Adverse Events|||Number
758202|NCT00607048|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the serum concentration time-curve from time zero to the last measured concentration. AUClast was estimated using non-compartmental methods on the sequence of sample measurements. Mean of individual observed AUClast values measured as nanograms multiplied by micrograms per milliliter (ng*mcg/mL).|Schedule A Day 3 of each 21 Day Cycle, Schedule B Day 8 of each 21 Day Cycle: Pre-dose, 5 minutes after end of infusion, and 2, 6, and 24 hours post-dose up to a maximum of 8 cycles (6 months)|Pharmacokinetic data analysis set; N=number of participants who did not have pre-dose levels of CP-870893.||hr*mcg/mL||Standard Deviation|Mean
758203|NCT00607048|Secondary|Maximum Observed Serum Concentration (Cmax)|Mean of individual observed Cmax values measured as micrograms per milliliter (mcg/mL).|Schedule A Day 3 of each 21 Day Cycle, Schedule B Day 8 of each 21 Day Cycle: Pre-dose, 5 minutes after end of infusion, and 2, 6, and 24 hours (hrs) post-dose up to a maximum of 8 cycles (6 months)|Pharmacokinetic data analysis set: all enrolled participants who started treatment and had baseline and sufficient on-study samples to provide interpretable results. N=number of participants who did not have pre-dose levels of CP-870893.||mcg/mL||Standard Deviation|Mean
758204|NCT00607048|Primary|Number of Participants With First Cycle Dose Limiting Toxicities (DLTs)|Any of the following during first cycle of treatment and attributable to CP-870893: Grade (Gr) 4 neutropenia (absolute neutrophil count [ANC] <500 cells/mm^3) for ≥7 days; Gr 3 or 4 febrile neutropenia (ANC <1000/mm^3, fever ≥38.5 degrees Celsius; platelets ≤25,000 cells/mm^3); ≥Gr 3 non-hematological adverse event despite optimal supportive care; ≥Gr 3 cytokine release syndrome or acute infusion reaction; failure to recover to Gr <1 toxicity after delaying next cycle by maximum of 2 weeks; Day 3 or 8 ANC <1000 cells/mm^3 or platelets <80000 cells/mm^3, or non-hematologic toxicity ≥Gr 2.|Schedule (Sch) A Cycle 1 / Day 3 or Schedule B Cycle 1 / Day 8 up to Cycle 1 / Day 21|Safety population: all participants who received at least 1 dose of study treatment.||participants|||Number
758205|NCT00607087|Secondary|Total Daily Bolus Insulin Dose|dose of every increment administered for example before meals|over 13 weeks of each treatment period|Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).||Units||Standard Deviation|Mean
758206|NCT00607087|Secondary|Total Daily Basal Insulin Infusion|dose of the basal insulin regimen administered throughout the 24-hour period|over 13 weeks of each treatment period|Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).||Units||Standard Deviation|Mean
758207|NCT00607087|Secondary|Glycosylated Hemoglobin: HbA1c|Glycolysated Haemoglobin (HbA1c) is a biological parameter that reflects the blood glucose concentration over a long period of time. It is the standard parameter for glycemic control follow-up in diabetic patients. This parameter is expressed in percentage (%) and the target in diabetes management is to reach a HbA1c <7%|over 13 weeks of each treatment period|Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).||percentage||Standard Deviation|Mean
758208|NCT00607087|Secondary|Time Interval Between Infusion Set Changes in Routine|"Patients treated with insulin pump have to change their infusion set regularly (i.e.change was recommended every 48h). The patients were asked to report any change of their infusion set and the reason for change (routine basis or because of occurrence of a specific event such as occlusion, unexplained hyperglycemia or adverse event).
Changes in routine correspond to interval between changes according to patient use."|over 13 weeks of each treatment period|Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).||hours||Standard Deviation|Mean
758209|NCT00607087|Secondary|Time Interval Between Infusion Set Changes: All Changes|"Patients treated with insulin pump have to change their infusion set regularly (i.e.change was recommended every 48h). The patients were asked to report any change of their infusion set and the reason for change (routine basis or because of occurrence of a specific event such as occlusion, unexplained hyperglycemia or adverse event).
All changes include all the changes whatever the reason such as routine or requested by occurrence of events."|over 13 weeks of each treatment period|Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).||hours||Standard Deviation|Mean
758210|NCT00607087|Secondary|Patients With at Least One Site Infection, Site Inflammation/Erythema, Pruritus or Isolated Pain at Injection Site|"Infection: local reaction at the infusion site requiring local or systemic antibiotherapy, or local drainage as per Investigator judgment.
Site inflammation or erythema: local reaction at the infusion site with no need for local or systemic antibiotherapy as per Investigator judgment.
Pruritis at injection site: presence of pruritis at the infusion site without any symptom of inflammation or erythema and/or infection.
Isolated pain at injection site: presence of pain at the infusion site without any symptom of inflammation or erythema and/or infection."|over 13 weeks of each treatment period|Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).||patients|||Number
758211|NCT00607087|Secondary|Rate of Nocturnal Symptomatic Hypoglycemia With a Plasma Glucose (PG) ≤70 mg/dL Per Patient-year|Nocturnal Symptomatic hypoglycemia was defined as an event with clinical symptoms that are considered to result from hypoglycemia (confirmed or not by a glucose measurement) and associated with prompt recovery after oral carbohydrate administration which occurs while the patient is asleep, after bedtime and before getting up in the morning.|over 13 weeks of each treatment period|Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).||events in patient-year||Standard Error|Mean
758212|NCT00607087|Secondary|Rate of Severe Symptomatic Hypoglycemia Per Patient-year|"Severe symptomatic hypoglycemia is defined as an event with clinical symptoms that are considered to results from hypoglycemia in which the patient required assistance of another person and one of the following:
the event was associated with a measured blood glucose level below 36 mg/dL
or event was associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration."|over 13 weeks of each treatment period|Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).||events in patient-year||Standard Error|Mean
758213|NCT00607087|Secondary|Rate of Symptomatic Hypoglycemia With a Plasma Glucose (PG) ≤ 70 mg/dL Per Patient-year|Symptomatic hypoglycemia is defined as an event with clinical symptoms that are considered to results from hypoglycemia (confirmed or not by a glucose measurement) and associated with prompt recovery after oral carbohydrate administration.|over 13 weeks of each treatment period|Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).||events in patient-year||Standard Error|Mean
758214|NCT00607087|Secondary|Monthly Rate of Episode of Significant Ketosis and/ or Risk Level for Impending Diabetic Ketoacidosis|"Diabetic ketoacidosis (DKA) is preceded by an increase in ketone production, resulting in blood ketone value increase (hyperketonemia) and later in ketone urine value (hyperketonuria).
Significant hyperketonemia and risk level for impending diabetic ketoacidosis (DKA) are reported respectively as a blood ketone value from 0.6 to 1.5 mmol/L and >1.5 mmol/l"|over 13 weeks of each treatment period|Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).||events per patient per month||Standard Error|Mean
758215|NCT00607087|Secondary|Percentage of Patients With at Least One Episode of Significant Ketosis and/ or Risk Level for Impending Diabetic Ketoacidosis|"Diabetic ketoacidosis (DKA) is preceded by an increase in ketone production, resulting in blood ketone value increase (hyperketonemia) and later in ketone urine value (hyperketonuria).
Significant hyperketonemia and risk level for impending diabetic ketoacidosis (DKA) are reported respectively as a blood ketone value from 0.6 to 1.5 mmol/L and >1.5 mmol/l"|over 13 weeks of each treatment period|Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).||percentage of patients||95% Confidence Interval|Number
758216|NCT00607087|Secondary|Monthly Rate of Confirmed Infusion Set Occlusion||over 13 weeks of each treatment period|Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).||events per patient per month||Standard Error|Mean
758217|NCT00607087|Secondary|Percentage of Patients With at Least One Confirmed Infusion Set Occlusion|"Pump infusion set occlusion defined by at least one of the following items:
pump occlusion alarm,
patient observation of an occlusion, spontaneously or because of elevated blood glucose value."|over 13 weeks of each treatment period|Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).||percentage of patients||95% Confidence Interval|Number
758218|NCT00607087|Secondary|Monthly Rate of Unexplained Hyperglycemia||over 13 weeks of each treatment period|Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).||events per patient per month||Standard Error|Mean
758219|NCT00607087|Secondary|Percentage of Patients With at Least One Unexplained Hyperglycemia|Unexplained hyperglycemia defined as blood glucose value above 300 mg/dL (16.7 mmol/L) with no apparent medical dietary, insulin dosage or pump failure reason.|over 13 weeks of each treatment period|Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).||percentage of patients||95% Confidence Interval|Number
758220|NCT00607087|Secondary|Monthly Rate of Unexplained Hyperglycemia and/ or Confirmed Infusion Set Occlusion|"Unexplained hyperglycemia defined as blood glucose value above 300 mg/dL (16.7 mmol/L) with no apparent medical dietary, insulin dosage or pump failure reason.
Pump infusion set occlusion defined by at least one of the following items:
pump occlusion alarm,
patient observation of an occlusion, spontaneously or because of elevated blood glucose value."|over 13 weeks of each treatment period|Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).||events per patient per month||Standard Error|Mean
758221|NCT00607087|Primary|Percentage of Patients With at Least One Unexplained Hyperglycemia and/ or Confirmed Infusion Set Occlusion|"Unexplained hyperglycemia defined as blood glucose value above 300 mg/dL (16.7 mmol/L) with no apparent medical dietary, insulin dosage or pump failure reason.
Pump infusion set occlusion defined by at least one of the following items:
pump occlusion alarm,
patient observation of an occlusion, spontaneously or because of elevated blood glucose value."|over 13 weeks of each treatment period|Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).||percentage of patients||95% Confidence Interval|Number
758286|NCT00615992|Secondary|Global Assessment of Efficacy by Patient|Rating scale ranging from very good (best value) to not satisfactory (worst value)|Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)|The discrepancy between the total number of participants and the numbers analyzed for a certain parameter is due to missing data.||Participants|||Number
758222|NCT00607113|Primary|Net Change Relative to Baseline in Tumor Blood Flow|Tumor blood flow (ml/min/100gm) determined by functional computed tomography (CT). Functional computed tomography (CT) at baseline, after first and third cycles (21 day cycles). Change (percentage) calculated as tumor blood flow measured at baseline compared to tumor blood flow measurement taken at end of Cycle 1, week 3 (21 days), and again at end of Cycle 3, Week 9 (63 days).|Baseline to end of Cycle 3 (63 days)|||ml/min/100gm||Standard Deviation|Mean
758227|NCT00607243|Secondary|Cell-mediate Immunity||14 or 28 days||||||
758228|NCT00607243|Secondary|Antibody Response||14 or 28 days||||||
758229|NCT00607243|Primary|Adverse Reactions||0-28 days||||||
758230|NCT00607243|Primary|Cutaneous Take Reaction|The “take reaction”was defined as a vesicular or pustular lesion or an area of definite palpable induration or congestion surrounding a central lesion (a crust or ulcer) occurring at the vaccination site at any of post-vaccination days (PVDs) 6–8. The vaccination site was photographed, and measures were taken.|7-9 day|||participants|||Number
758231|NCT00607269|Secondary|Self-reported Sexual Behaviors at 12-month Follow-up|Count of recent (past 30 days) male sexual partners.|12 months|||Sexual Partners||Standard Deviation|Mean
758232|NCT00607269|Secondary|Self-reported Psychiatric Symptoms at 12-month Follow-up.|As measured by the General Severity Index (GSI), a summary domain included on the Brief Symptom Inventory. The GSI combines information on both the number of symptoms described and the severity of those symptoms. Lower values on the GSI indicate less severe symptoms. Normative non-patient populations have been shown to have average GSI scores with a mean of 0.30 and a standard deviation of 0.31. Normative outpatient psychiatric patients have demonstrated GSI scores with a mean of 1.32 with a standard deviation of 0.72.|12 months|||Units of General Severity Index||Standard Deviation|Mean
758233|NCT00607269|Primary|Proportion of Level 1 (i.e., Drug Negative Urines and Alcohol Negative Breath) Clean Urine Samples Provided at 12-month Follow-up, by Condition.||24 Weeks|||Proportion of Lvl 1 Clean Urine Samples|||Number
758234|NCT00607269|Primary|Amount ($) Earned for Targeted Prosocial and Healthy Behaviors|Participants earned contingency management vouchers for targeted prosocial and healthy behaviors. 1 voucher = $1|24 Weeks|||$ Vouchers||Standard Deviation|Mean
758235|NCT00613730|Secondary|Percentage of Participants With Overall Response|Overall Response defined as the percentage of participants with complete or partial response (CR or PR), as defined by modified RECIST. CR: Disappearance of all target and non-target lesions. PR: Either at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameters (SLD) and no progression of existing non-target lesions and no new lesions, or, the disappearance of all target lesions with persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease and no new lesions.|Overall study|Study was terminated after enrolling 3 participants. This outcome was not evaluated.|||||
758236|NCT00613730|Secondary|Progression-free Survival|Progression-Free Survival was defined as the time from Study Day 1 to the date of disease progression or the date of death due to any cause (whichever comes earlier). Disease progression is determined per Response Evaluation Criteria in Solid Tumors (RECIST) criteria or per physician’s assessment based on symptom progression.|Up to 25 months|Study was terminated after enrolling 3 participants. This outcome was not evaluated.|||||
758237|NCT00613730|Primary|Overall Survival at 1 Year|"The survival time is calculated from Study Day
1 (ie, the first day that a participant receives study treatment with the gemcitabine regimen in combination with panitumumab) to the date of death due to any cause."|12 months|Study was terminated after enrolling 3 participants. This outcome was not evaluated.|||||
758238|NCT00613821|Primary|The Effects of an Intrauterine Lidocaine Infusion to Standard Paracervical Block on Decreasing Patient Pain Measured by Visual Analog Scale in First Trimester Abortions.|Subjects perception of pain is measured using a 100mm visual analog scale (VAS).The 100mm Pain Visual Analog Scale (VAS) is an instrument used to capture subjective attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of pain by indicating a position along a 100mm continues line: pain scores can range from 0 (no pain) to 100 (worst pain imaginable).|Immediately (time zero) at uterine aspiration|||mm||Standard Deviation|Mean
758239|NCT00613925|Secondary|Sample Adequacy|adequacy of sample obtained for examination by a pathologist|at time of biopsy|||percentage of participants|||Number
758240|NCT00613925|Primary|Compare Pipelle and Explora Curette Groups With Respect to Patient Perception of Pain Associated With the Procedure as Rated by a 100mm Visual Analog Scale (VAS).|"The 100mm Pain Visual Analog Scale (VAS) is an instrument used to capture subjective attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of pain by indicating a position along a 100mm continues line: pain scores can range from 0=No Pain (furthest point to the left) to 100=Worst Pain in My Life (furthest point to the right)."|2 minutes after biopsy procedure|To demonstrate a 20 mm difference on the 100 mm visual analog scale, sample size of 35 women in each group (80% power, 0.05 alpha, SD 30mm)||mm||Standard Deviation|Mean
758241|NCT00613938|Secondary|Total Pain Relief (TOTPAR)at 48 Hours|Total Pain Relief (TOTPAR48) was defined as the weighted sum over all pain relief scores(PAR) from 0.5 hour to Hour 48, with the actual time elapsed from the previous PAR observation as the weight. A higher value in TOTPAR indicates greater pain relief.|48 hours|Intent-to-treat||scores on a scale||Standard Deviation|Mean
758242|NCT00613938|Secondary|Percentage of Patients Who Reported Very Much Improved or Much Improved From Baseline in Patient Global Impression of Change to Day 3|Ordinal measure indicating change from the start of treatment (On a scale of 7 = Very much Worse to 1 = very much improved) to endpoint at Day 3|Baseline and 3 days|The primary analysis set was the Intent to Treat (ITT) analysis set that included all subjects who were randomized, received at least one dose of study drug and had a non-missing baseline pain intensity score.||percentage of participants|||Number
758243|NCT00613938|Secondary|SPID at 24 Hours Relative to First Dose|The SPID score incorporates the cumulative analgesic effects of tapentadol IR on pain intensity over an extended period (12 to 72 hours) allowing for an evaluation of multiple doses of drug, even when dosing frequency may vary. Scoring is derived from the Numerical Rating Scale (NRS) from 0 = No pain to 11 = Pain as bad as you can imagine. A positive difference between the mean SPID24 for an active study drug and placebo would indicate a numerically larger analgesic effect for subjects dosed with active study drug than in the placebo group. A higher value in SPID indicates greater pain relief.|24 hours|The primary analysis set was the Intent to Treat (ITT) analysis set that included all subjects who were randomized, received at least one dose of study drug and had a non-missing baseline pain intensity score.||Scores on a scale||Standard Deviation|Mean
758244|NCT00613938|Secondary|The SPID at 12 Hours Relative to First Dose.|The SPID score incorporates the cumulative analgesic effects of tapentadol IR on pain intensity over an extended period (12 to 72 hours) allowing for an evaluation of multiple doses of drug, even when dosing frequency may vary. Scoring is derived from the Numerical Rating Scale (NRS) from 0 = No pain to 11 = Pain as bad as you can imagine. A positive difference between the mean SPID12 for an active study drug and placebo would indicate a numerically larger analgesic effect for subjects dosed with active study drug than in the placebo group. A higher value in SPID indicates greater pain relief.|12 hours|The primary analysis set was the Intent to Treat (ITT) analysis set that included all subjects who were randomized, received at least one dose of study drug and had a non-missing baseline pain intensity score.||Scores on a scale||Standard Deviation|Mean
758245|NCT00613938|Secondary|Time to First Rescue Pain Medication Use.|The effect of tapentadol (CG5503) IR on the time to the first use of rescue pain medication.|3 days|The primary analysis set was the Intent to Treat (ITT) analysis set that included all subjects who were randomized, received at least one dose of study drug and had a non-missing baseline pain intensity score.|||||
758246|NCT00613938|Primary|Sum of Pain Intensity Difference Over 48 Hours (SPID48)|The SPID score incorporates the cumulative analgesic effects of tapentadol IR on pain intensity over an extended period (48 hours) allowing for an evaluation of multiple doses of drug, even when dosing frequency may vary. Scoring is derived from the Numerical Rating Scale (NRS) from 0 = No pain to 11 = Pain as bad as you can imagine. A positive difference between the mean SPID48 for an active study drug and placebo would indicate a numerically larger analgesic effect for subjects dosed with active study drug than in the placebo group. A higher value in SPID indicates greater pain relief.|48 hours|The primary analysis set was the Intent to Treat (ITT) analysis set that included all subjects who were randomized, received at least one dose of study drug and had a non-missing baseline pain intensity score.||Scores on a scale||Standard Deviation|Mean
758247|NCT00613951|Secondary|Physical Examination|Physical examination was performed at screening (week -4), and after 8 and 16 weeks of treatment. If any new findings or deterioration in previous findings were observed during the trial, these were recorded as AEs and are therefore not presented separately as no analysis was performed.|Week -4, Week 8, Week 16||||||
758248|NCT00613951|Secondary|Vital Signs: Pulse|Values at baseline (Week 0) and at Week 16|Week 0, Week 16|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. From the SAS, 58 (SIAC 30), 56 (SIAC 45) and 58 (BIAsp 30) subjects contributed to the analysis at week 16.||beats/minute||Standard Deviation|Mean
758249|NCT00613951|Secondary|Vital Signs: Systolic Blood Pressure (BP)|Values at baseline (Week 0) and at Week 16|Week 0, Week 16|The safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator. From the SAS, 58 (SIAC 30), 56 (SIAC 45) and 58 (BIAsp 30) subjects contributed to the analysis at week 16.||mmHg||Standard Deviation|Mean
758250|NCT00613951|Secondary|Vital Signs: Diastolic Blood Pressure (BP)|Values at baseline (Week 0) and at Week 16|Week 0, Week 16|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. From the SAS, 58 (SIAC 30), 56 (SIAC 45) and 58 (BIAsp 30) subjects contributed to the analysis at week 16.||mmHg||Standard Deviation|Mean
758251|NCT00613951|Secondary|Laboratory Safety Parameters (Biochemistry): Serum Creatinine|Laboratory values at screening (Week -4) and at Week 16|Week -4, Week 16|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. For 2 subjects the laboratory values were missing at week -4. From the SAS, 56 (SIAC 30), 57 (SIAC 45) and 56 (BIAsp 30) subjects contributed to the analysis at week 16.||umol/L||Standard Deviation|Mean
758252|NCT00613951|Secondary|Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT)|Laboratory values at screening (Week -4) and at Week 16|Week -4, Week 16|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. For 3 subjects the laboratory values were missing at week -4. From the SAS, 54 (SIAC 30), 57 (SIAC 45) and 53 (BIAsp 30) subjects contributed to the analysis at week 16.||IU/L||Standard Deviation|Mean
758253|NCT00613951|Secondary|Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT)|Laboratory values at screening (Week -4) and at Week 16|Week -4, Week 16|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. For 2 subjects the laboratory values were missing at week -4. From the SAS, 54 (SIAC 30), 57 (SIAC 45) and 53 (BIAsp 30) subjects contributed to the analysis at week 16.||IU/L||Standard Deviation|Mean
758281|NCT00615927|Secondary|Median Progression-free Survival|Time in weeks from the start of cycle 1 to the date of first progression according to modified Macdonald criteria, or to death due to any cause. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve.|Time in weeks from the start of cycle 1 to the date of first progression according to modified Macdonald criteria or to death due to any cause, assessed up to 156 weeks|||weeks||95% Confidence Interval|Median
760303|NCT00634569|Secondary|Number of Days on Antibiotics (Prophylactic and Therapeutic).|Median Combined number of days on prophylactic and therapeutic antibiotics|12 months|||Days||Standard Deviation|Median
758254|NCT00613951|Secondary|Rate of Treatment Emergent Adverse Events (AEs)|Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject’s daily activities. Moderate: marked symptoms, moderate interference with subject’s daily activities. Severe: considerable interference with subject’s daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.|Week 0 to Week 16 + 5 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||Events/100 years of patient exposure|||Number
758255|NCT00613951|Secondary|Rate of Nocturnal Major and Minor Hypoglycaemic Episodes|Rate of nocturnal major and minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Episodes were defined as nocturnal if the time of onset was between 23:00 (included) and 05:59 (included).|Week 0 to Week 16 + 5 days follow up|The full analysis set (FAS) included all randomised subjects.||Episodes/100 years of patient exposure|||Number
758256|NCT00613951|Secondary|Rate of Major and Minor Hypoglycaemic Episodes|Observed rate of major and minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 16 + 5 days follow up|The full analysis set (FAS) included all randomised subjects.||Episodes/100 years of patient exposure|||Number
758257|NCT00613951|Secondary|Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)|Estimate of the overall mean of SMPG after 16 weeks of treatment. Plasma glucose measured: before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, before bedtime, at 4 am and before breakfast.|Week 16|The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF). For 2 subjects, mean SMPG values were missing.||mmol/L||Standard Error|Least Squares Mean
758258|NCT00613951|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Change from baseline in HbA1c after 16 weeks of treatment|Week 0, Week 16|The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF). HbA1c values were missing for 2 subjects, hence did not contribute to the analysis||percentage of glycosylated haemoglobin||Standard Deviation|Mean
758259|NCT00615719|Primary|The Presence of Acute Coronary Syndromes(ACS).|The presence of ACS was determined by either cardiac angiography, nuclear perfusion imaging or a clinical course deemed consistent with ACS by final chart review. The number of participants with ACS was determined.|During the presenting illness, usually within two to three days.|Only 30 evaluable patients in study powered for 80 patients.||participants|||Number
758260|NCT00615836|Secondary|Participants With Treatment-Emergent Adverse Events (AEs)|"An AE was any untoward medical occurrence that did not necessarily have a causal relationship with the study drug. An adverse drug reaction (ADR) was an AE evaluated by the Investigator as being probably or possibly causally related to treatment with the study drug.
A serious AE (SAE) was any event that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity or congenital anomaly/birth defect or was an important medical event that could have jeopardized the patient's safety or required medical or surgical intervention to prevent 1 of the outcomes listed above. The intensity of an AE was defined as severe if it resulted in the inability to work or perform usual activities."|From first dose of study drug in Study CS29 until the end of study CS31 (up to 35 months).|Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure; therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.||participants|||Number
758261|NCT00615836|Secondary|Change From Baseline in the Short Form-12, Version 2 (SF-12v2) Physical Component Summary Score|"The SF-12v2 was used to measure the impact of nocturia and lack of sleep on general quality of life. The SF-12 consists of 12 questions spanning 8 domains: physical functioning, role function-physical, role function-emotional, bodily pain, general health, vitality, social functioning, and mental health. These scales are combined to create 2 summary measures: the Physical Health Summary and Mental Health Summary. The Physical Health Summary score ranges from 0 to 100, where higher numbers indicate better quality of life.
Participants in the 10μg arm are included only until the time of dose escalation."|Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months)|Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received >=1 dose of study drug and provided >=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.||units on a scale||Standard Deviation|Mean
758262|NCT00615836|Secondary|Change From Baseline in the Short Form-12, Version 2 (SF-12v2) Mental Component Summary Score|"The SF-12v2 was used to measure the impact of nocturia and lack of sleep on general quality of life. The SF-12 consists of 12 questions spanning 8 domains: physical functioning, role function-physical, role function-emotional, bodily pain, general health, vitality, social functioning, and mental health. These scales are combined to create 2 summary measures: the Physical Health Summary and Mental Health Summary. The Mental Health Summary score ranges from 0 to 100, where higher numbers indicate better quality of life.
Participants in the 10μg arm are included only until the time of dose escalation."|Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months)|Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received >=1 dose of study drug and provided >=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.||units on a scale||Standard Deviation|Mean
758282|NCT00615927|Primary|12-month Progression Free Survival (PFS)|Percentage of participants surviving twelve months from the start of cycle 1 without progression of disease. PFS was defined as the time from the cycle 1 start date to the date of the first documented progression according to modified Macdonald criteria, or to death due to any cause.|12 months|||percentage of participants||95% Confidence Interval|Number
758263|NCT00615836|Secondary|Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Global Score|"The PSQI is a self-administered 19-item questionnaire designed to assess sleep quality and disturbances. The 19 individual items are scored on an evenly weighted 0 to 3 scale and generate 7 component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these 7 components yields 1 global score ranging from 0 to 21. Higher numbers indicate greater sleep disturbance.
Participants in the 10μg arm are included only until the time of dose escalation."|Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months)|Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received >=1 dose of study drug and provided >=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.||units on a scale||Standard Deviation|Mean
758264|NCT00615836|Secondary|Change From Baseline in the Nocturia Quality of Life (NQoL) Global Quality of Life Score|"The NQoL is a self-administered 13-item questionnaire designed to assess the impact of nocturia on quality of life. It contains a sleep/energy domain (6 questions), a bother/concern domain (6 questions), and 1 global QoL question. The global QoL question is scored on a scale ranging from 0 (not at all) to 10 (a great deal). Higher numbers indicate better impact on quality of life.
Participants in the 10μg arm are included only until the time of dose escalation."|Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months)|Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received >=1 dose of study drug and provided >=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.||units on a scale||Standard Deviation|Mean
758265|NCT00615836|Secondary|Change From Baseline in Nocturia Quality of Life (NQoL) Sleep/Energy Domain Score|"The NQoL is a self-administered 13-item questionnaire designed to assess the impact of nocturia on quality of life. It contains a sleep/energy domain (6 questions), a bother/concern domain (6 questions), and 1 global QoL question. The 12 core items are scored on a 0 to 4 scale with higher numbers indicating a better quality of life. The sleep/energy domain summary score is calculated by transforming the raw score into a 0-100 scale with higher numbers indicating a better impact on quality of life.
Participants in the 10μg arm are included only until the time of dose escalation."|Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months)|Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received >=1 dose of study drug and provided >=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.||units on a scale||Standard Deviation|Mean
758266|NCT00615836|Secondary|Change From Baseline in NQoL Bother/Concern Domain Score|"The NQoL is a self-administered 13-item questionnaire designed to assess the impact of nocturia on quality of life. It contains a sleep/energy domain (6 questions), a bother/concern domain (6 questions), and 1 global QoL question. The 12 core items are scored on a 0 to 4 scale with higher numbers indicating a better quality of life. The bother/concern domain summary score is calculated by transforming the raw score into a 0-100 scale with higher numbers indicating a better impact on quality of life.
Participants in the 10μg arm are included only until the time of dose escalation."|Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months)|Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received >=1 dose of study drug and provided >=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.||units on a scale||Standard Deviation|Mean
758267|NCT00615836|Secondary|Change From Baseline in Nocturia Quality of Life (NQoL) Overall Score|"The NQoL is a self-administered 13-item questionnaire designed to assess the impact of nocturia on quality of life. It contains a sleep/energy domain (6 questions), a bother/concern domain (6 questions), and 1 global QoL question (which is not included in the overall score). The 12 core items are scored on a 0 to 4 scale, and the overall score is calculated by transforming the raw score into a 0-100 scale with higher numbers indicating better impact on quality of life.
Participants in the 10μg arm are included only until the time of dose escalation."|Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months)|Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received >=1 dose of study drug and provided >=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.||units on a scale||Standard Deviation|Mean
758268|NCT00615836|Secondary|Change From Baseline in International Consultation on Incontinence Modular Questionnaire - Nocturia (ICIQ-N) Nighttime Urination Bother Score|"The ICIQ-N is a self-administered 4-item questionnaire designed to assess the frequency and bother of daytime and nighttime urination. To assess nighttime urination bother, participants were asked to rate the degree of bother of nighttime urination by answering the question “Night time urination: How much does this bother you?” on a scale ranging from 0 (not at all) to 10 (a great deal). Higher numbers indicate greater bother.
Participants in the 10μg arm are included only until the time of dose escalation."|Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months)|Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received >=1 dose of study drug and provided >=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.||units on a scale||Standard Deviation|Mean
758283|NCT00615992|Secondary|Global Assessment of Tolerability by Physician|Rating scale ranging from very good (best value) to not satisfactory (worst value)|Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)|The discrepancy between the total number of participants and the numbers analyzed for a certain parameter is due to missing data.||Participants|||Number
760147|NCT00633152|Secondary|Clinical and Microbiological Response by Pathogen at the TOC Visit in the mMITT and ME Populations|Evaluate the clinical and microbiological response by pathogen at the TOC Visit in the mMITT and ME populations.|TOC Visit (8 to 15 days after end of therapy)||||||
758269|NCT00615836|Secondary|Change From Baseline in Total Sleep Time|"Participants completed a sleep diary on 3 consecutive mornings prior to each study visit, from which the total sleep time was calculated and averaged for the 3 days. Baseline refers to Baseline of Study CS29 and the number of weeks represents the total exposure to study drug.
Participants in the 10μg arm are included only until the time of dose escalation."|Baseline of Study CS29 and Weeks 8, 12, 20, 28, 52-56, 72-76, and 92-96.|Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received >=1 dose of study drug and provided >=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.||minutes||Standard Deviation|Mean
758270|NCT00615836|Primary|Change From Baseline in Initial Period of Undisturbed Sleep|"Participants completed a sleep diary on 3 consecutive mornings prior to each study visit, from which the initial period of undisturbed sleep was calculated and averaged for the 3 days. The Initial Period of Undisturbed Sleep is the time elapsed from bedtime to either first void or morning arising minus the minutes it took to fall asleep. Baseline refers to Baseline of Study CS29 and the number of weeks represents the total exposure to study drug.
Participants in the 10μg arm are included only until the time of dose escalation."|Baseline of Study CS29 and Weeks 8, 12, 20, 28, 52-56, 72-76, and 92-96.|Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received >=1 dose of study drug and provided >=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.||minutes||Standard Deviation|Mean
758271|NCT00615836|Primary|Percentage of Participants With a Greater Than 33% Reduction in the Mean Number of Nocturnal Voids|"Percentage of participants with >33% reduction from Baseline in the mean number of nocturnal urinations per night, calculated from the 3-day voiding diary completed prior to each study visit.
Participants in the 10μg arm are included only until the time of dose escalation."|Baseline of Study CS29 and Weeks 8, 12, 20, 28, 52-56, 72-76, and 92-96.|Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received >=1 dose of study drug and provided >=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.||percentage of participants|||Number
758272|NCT00615836|Primary|Change From Baseline in Mean Number of Nocturnal Voids|"Participants completed a voiding diary for 3 consecutive 24-hour periods prior to the study visit in which they recorded each nocturnal urination (void). The mean number of voids per night was the average number of voids from the 3-day diary. Baseline refers to Baseline of Study CS29 and the number of weeks represents the total exposure to study drug.
Participants in the 10μg arm are included only until the time of dose escalation."|Baseline of Study CS29 and Weeks 8, 12, 20, 28, 52-56, 72-76, and 92-96.|Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received >=1 dose of study drug and provided >=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.||nocturnal voids||Standard Deviation|Mean
758273|NCT00615901|Primary|The Number of Patients Who Completed 8 Cycles.|the study regimen is deemed feasible and tolerable for patients with ANC > 1.5 on day 1 of treatment for all 8 cycles and absence of grade 3 or higher non-hematologic toxicity, excluding alopecia, nausea/vomiting and bone pain We will also evaluate the total number of days needed to complete all 8 cycles.|2 years|||participants|||Number
758274|NCT00615914|Primary|Proportion of Adverse Events, Adverse Drug Reactions, Serious Adverse Events|The aim of this Post Marketing Surveillance (PMS) was to obtain long-term safety data with treatment of pramipexole in Parkinson's disease (PD) patients. Therefore these items were considered as a safety evaluation.|during 18 months|Patients excluded from 1581 patients were: 15 who had no visit since the first prescription, 2 for no treatment, 10 patients who were irregularly enrolled patients (exclusion from analysis according to regulatory requirement) and 1 patient that had no safety data available. As a result, there were 1553 patients in the safety analysis set.||percentage of participants|||Number
758275|NCT00615914|Secondary|Change From Baseline in Modified Hoehn & Yahr Rating Scale|A severity of PD symptom are assessed by Modified Hoehn & Yahr rating scale. This scale consist of 10 levels including additional evaluation levels defined in Japan. Ten levels are described by 0 (best), 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5 (worst).|Baseline and at 18 months (or at the time of discontinuation)|The number of patients from the efficacy analysis set (1527) who had the assessment of Modified Hoehn & Yahr rating scale at baseline and at or after 18 months of treatment or at the time of discontinuation (1430).||Unit on a scale||Standard Deviation|Mean
758276|NCT00615914|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score|Motor examination is assessed by 27 questionnaire items in UPDRS Part III section. Each item is scored from 0 (best) to 4 (worst), and the total score of UPDRS Part III is from 0 (best) to 108 (worst). A decrease in the score means improvement.|Baseline and at 18 months (or at the time of discontinuation)|The number of patients from the efficacy analysis set (1527) who had the assessment of UPDRS Part III total score at baseline and at or after 18 months of treatment or at the time of discontinuation (1356).||Unit on a scale||Standard Deviation|Mean
758277|NCT00615914|Secondary|Clinical Global Impression of Improvement|Investigators evaluation of the PD symptoms on a rating scale of 5 categories (very much improved, much improved, minimally improved, no effect, and unassessable).|18 months|A total of 26 patients were excluded from 1553 patients (Administration to patients who did not suffer from PD: 20, No efficacy data available: 6). As a result, 1527 patients included to the efficacy analysis set.||Participants|||Number
758278|NCT00615927|Secondary|Safety and Tolerability of Gleevec + Hydroxyurea in Patients With Low-grade Gliomas|The number of patients experiencing any serious adverse event or other (non-serious) adverse event during the study participation.|156 weeks|||participants|||Number
758279|NCT00615927|Secondary|Objective Response Rate|Number of participants with an objective response (complete response or partial response) based on modified Macdonald criteria.|156 weeks|||participants|||Number
758280|NCT00615927|Secondary|Median Overall Survival (OS)|Time in weeks from the start of cycle 1 to date of death due to any cause. Patients alive at last follow-up are censored as of that follow-up date. Median OS was estimated using a Kaplan-Meier curve.|Time in weeks from the start of cycle 1 to date of death due to any cause, assessed up to 156 weeks|Median overall survival was not estimable for either arm as not enough events of death occurred||weeks||95% Confidence Interval|Median
758287|NCT00615992|Secondary|Dyspnea Score After 3 to 4 Weeks Treatment With Spiriva|The scores are final, not a difference in score. Rating scale scored from 0 (no restrictions in activities) to 4 (severe restrictions)|Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)|The discrepancy between the total number of participants and the numbers analyzed for a certain parameter is due to missing data.||points on a scale||Standard Deviation|Mean
758288|NCT00615992|Primary|Activities of Daily Living Score After 3 to 4 Weeks Treatment With Spiriva|The scores are final, not a difference in score. Rating scale scored from 0 (no restrictions in activities) to 4 (severe restrictions)|Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)|The discrepancy between the total number of participants and the numbers analyzed for a certain parameter is due to missing data.||points on a scale||Standard Deviation|Mean
758289|NCT00616018|Secondary|Alanine Aminotransferase (ALT)|ALT was measured at Day 0, 4, 7, 9, 11, and 14.|Day 0, 4, 7, 9, 11, and 14.|Analysis is based upon the 24 subjects who completed all study visits.||IU/L||Standard Deviation|Mean
758290|NCT00616018|Primary|Serum Level of Acetaminophen-cysteine (APAP-Cys) Protein Adducts|Acetaminophen-cysteine (APAP-Cys) protein adduct concentrations were measured at Day 0, 4, 7, 9, 11 and 14. All units are in nmol/mL serum.|Day 0, 4, 7, 9, 11, and 14.|Analysis is based upon the 24 subjects who completed all study visits.||nmol/mL||Standard Deviation|Mean
758291|NCT00616109|Secondary|Number of Patients That Discontinue Drug Due to Toxicity|"Tolerability of Sunitinib will be evaluated by looking at the number of participants who discontinue drug due to toxicity. Toxicity was graded according to the National Cancer Institute (NCI) Common Toxicity Criteria v.3.0.
In the event of any CTC, version 3.0 drug-related grade 3 or 4 non-hematologic or grade 4 hematologic adverse event(s), drug should be held until the toxicity resolves to < grade 1 and then the drug should be restarted at a one dose-level reduction.
Recovery to acceptable levels of toxicity must occur within 4 weeks to allow continuation in the study.
No more than 2 dose reductions are permitted for any patient. If further dose reduction is required, the patient must be removed from the study."|20 weeks|All patients who received sunitinib maintenance therapy were evaluable for toxicity and tolerability analysis.||participants|||Number
758292|NCT00616109|Secondary|Percent of Patients With an Objective Response|Scans were performed every 2 cycles to evaluate for response/progression. Response was assessed according to RECIST (Response Evaluation Criteria in Solid Tumors) criteria. Patients would be considered to have an objective response if they experience CR (Complete Response - Disappearance of all clinical and radiological evidence of target lesions and/or non-target lesions) or PR (Partial Response - A 30% or greater decrease in the sum of LD of all lesions in reference to the baseline sum LD).|12 weeks (2 cycles)|Patients who received at least 2 cycles of study therapy (maintenance sunitinib)||percentage of participants|||Number
758293|NCT00616109|Secondary|Median Overall Survival|Survival will be defined as the time from the first day of therapy to the date of death. If the patient is lost to follow-up, survival will be censored on the last date the patient was known to be alive. Survival for induction therapy will be calculated from day 1 of first cycle of chemotherapy. Survival for post-induction therapy will be calculated from the date the patient starts sunitinib.|up to 4 months post treatment|15 participants in Sunitinib maintenance therapy (main study) were enrolled and were evaluable for this outcome measure. Although 16 patients were enrolled, one patient opted to discontinue therapy, refused further follow-up, and was therefore censored from survival analysis.||months||95% Confidence Interval|Median
758294|NCT00616109|Primary|Progression Free Survival Rate|The proportion of patients who are progression-free at 4 months after starting sunitinib.|4 Months Post Treatment|All 16 patients enrolled received a median of 4 weeks sunitinib maintenance therapy. 1 patient who discontinued requested no follow up and was censored from survival analysis. All survival endpoints were analyzed using the Kaplan-Meier method (Kaplan El, Meier P, Non-parametric Estimation from Incomplete Observations, J Am Stat Association, 1958)||percentage of patients with PFS||95% Confidence Interval|Number
758295|NCT00616122|Secondary|Correlation of Outcome Measures With Possible Surrogate Markers Including Serial Measurements of Circulating Tumor Cells and Circulating Endothelial Cells||until disease progression up to 13 months post treatment||||||
758296|NCT00616122|Secondary|Duration of Response|duration of response refers to duration of single partial response observed per Response Evaluation Criteria in Solid Tumors (RECIST): Complete Response (CR): Complete disappearance of all measurable and evaluable disease. No new lesions. Partial Response (PR): greater than or equal to 50% decrease under baseline in the sum of the products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions. Stable: Does not qualify for complete response, partial response or progression. Progression: 25% increase or an increase of 10 sq. cm (whichever is smaller) in the sum of products of measurable lesions over smallest sum observed (over baseline if no decrease), OR appearance of any lesion which had disappeared, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to deteriorating condition (unless deterioration is clearly unrelated to this cancer).|until disease progression up to 13 months post treatment|A partial response was only reported for one patient, while a complete response was not recorded for any patients.||weeks|||Number
758297|NCT00616122|Secondary|Response|"Per Response Evaluation Criteria in Solid Tumors (RECIST):
Complete Response (CR): Complete disappearance of all measurable and evaluable disease. No new lesions. Partial Response (PR): greater than or equal to 50% decrease under baseline in the sum of the products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions. Stable: Does not qualify for complete response, partial response or progression. Progression: 25% increase or an increase of 10 sq. cm (whichever is smaller) in the sum of products of measurable lesions over smallest sum observed (over baseline if no decrease), OR appearance of any lesion which had disappeared, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to deteriorating condition (unless deterioration is clearly unrelated to this cancer)."|until disease progression up to 13 months post treatment|||participants|||Number
758298|NCT00616122|Primary|PFS Greater Than or Equal to 12 Weeks (Phase II)|"Per Response Evaluation Criteria in Solid Tumors (RECIST):
Complete Response (CR): Complete disappearance of all measurable and evaluable disease. No new lesions. Partial Response (PR): greater than or equal to 50% decrease under baseline in the sum of the products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions. Stable: Does not qualify for complete response, partial response or progression. Progression: 25% increase or an increase of 10 sq. cm (whichever is smaller) in the sum of products of measurable lesions over smallest sum observed (over baseline if no decrease), OR appearance of any lesion which had disappeared, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to deteriorating condition (unless deterioration is clearly unrelated to this cancer)."|12 weeks|Patients who received either 25mg or 37.5mg of sunitinib and were not removed from study due to voluntary withdrawal or POD prior to receiving combination sunitinib and metronomic CM chemotherapy.||participants|||Number
758299|NCT00616122|Primary|Maximum Tolerated Dose (Phase I)|"Patients in each cohort were followed for DLT for at least 8 weeks (2 week lead-in with sunitinib and 6 weeks of treatment with sunitinib and metronomic cyclophosphamide and methotrexate) before opening accrual to the next dose level.
Dose limiting toxicity (DLT):
≥ grade 3 anemia that does not resolve with appropriate growth factors afebrile grade 4 neutropenia that does not resolve with growth factor support after ≥ 7 days
grade 4 neutropenia associated with fever (1 reading of oral temperature > 38.5 ºC or 3 readings of oral temperature > 38.0 ºC in a 24 hour period)
≥ grade 3 thrombocytopenia
≥ grade 3 non-hematologic toxicities, except those that can be controlled to grade 2 or less with appropriate treatment.
Inability to resume treatment with any of the study medications within 14 days of stopping due to treatment related toxicity."|8 weeks|||mg|||Number
758303|NCT00616239|Secondary|Improvement of Melasma Based on MASI Scores, Melasma Severity Assessment, and Physician and Patient Global Improvement Compared With the Opposite Side.||14 weeks||||||
758304|NCT00616239|Primary|Number of Participants Showing Improvement of Melasma Based on Mexameter Readings|The degree of participants pigmentation was measured from the affected and unaffected skin on both sides of the face using a narrowband reflectance spectrophotometer.|14 weeks|||participants|||Number
758305|NCT00616343|Primary|Tremor Severity|PI has left the institution and we are unable to accurately assess the data from the remaining records.|4 weeks||||||
758306|NCT00616421|Secondary|Percentages of Subjects With Unsolicited AEs Occurring Throughout the Study in Children Aged 2 to 10 Years - 1 Dose Vaccine Treatment.|Safety was assessed in terms of the percentage of subjects with unsolicited AEs occurring throughout the entire study period, after 1 dose treatment.|day 1 to study termination (day 240)|The analysis was performed on safety population. Only groups receiving 1 dose vaccine are reported.||Percentage of Subjects|||Number
758307|NCT00616421|Secondary|Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 6 to 10 Years of Age - 1 Dose Vaccine Treatment.|Safety was assessed in terms of the percentages of subjects with reported local and systemic reactions up to 7 days after each vaccination per vaccination group after 1 dose treatment.|Study days 1 to 7|The analysis was performed on the safety population. Only groups receiving 1 dose vaccine are reported.||Percenatage of subjects|||Number
758308|NCT00616421|Secondary|Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age - 1 Dose Vaccine Treatment.|Safety was assessed in terms of the percentages of subjects with reported local and systemic reactions up to 7 days after each vaccination per vaccination group, after 1 dose treatment.|Study days 1 to 7|The analysis was performed on the safety population. Only groups receiving 1 dose vaccine are reported.||Percentages of subjects|||Number
758309|NCT00616421|Secondary|GMTs (hSBA) in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose)|"The immunogenicity of two doses of the Novartis MenACWY-CRM vaccine, administered 2 months apart, is compared with the immunogenicity of a single dose of the Novartis MenACWY-CRM vaccine, in terms of hSBA (human Serum Bactericidal Activity) GMTs (Geometric Mean Titers) against N. meningitidis serogroups A, C, W-135, and Y.
ANOVA model used for the analysis of this outcome is different compare to ANOVA model used for the other outcome. The computed model components vary according to the variance observed due to the different datasets."|1 month postvaccination|The analysis was performed on the per-protocol (PP) population.||Titers||95% Confidence Interval|Geometric Mean
758310|NCT00616421|Secondary|Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose)|"The immunogenicity of two doses of the Novartis MenACWY-CRM, administered 2 months apart, is compared with the immunogenicity of a single dose of the Novartis MenACWY-CRM, directed against N. meningitidis serogroups A, C, W-135, and Y.
Seroresponse: For a subject with hSBA <1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline."|1 month postvaccination|The analysis was performed on the per-protocol (PP) population.||Percentages of subjects||95% Confidence Interval|Number
758311|NCT00616421|Secondary|Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age (2 Doses vs 1 Dose)|"The immunogenicity of two doses of the Novartis MenACWY-CRM, administered 2 months apart, is compared with the immunogenicity of a single dose of the Novartis MenACWY-CRM, directed against N. meningitidis serogroups A, C, W-135, and Y.
Seroresponse: For a subject with hSBA <1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline."|1 month postvaccination|The analysis was performed on the per-protocol (PP) population.||Percentages of subjects||95% Confidence Interval|Number
758312|NCT00616421|Secondary|Geometric Mean Titers (hSBA), in Healthy Children 2 to 5 and 6 to 10 Years of Age.|The immunogenicity of a single dose of the Novartis MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the number of subjects with hSBA (human Serum Bacterial Activity) Geometric Mean Titers (GMTs) response against N. meningitidis serogroups A, C, W-135, and Y.|1 month postvaccination|The analysis was performed on the per-protocol (PP) population.||Titers||95% Confidence Interval|Geometric Mean
758313|NCT00616421|Secondary|Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 and 6 to 10 Years of Age.|The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percenategs of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y.|1 month postvaccination|The analysis was performed on the per-protocol (PP) population.||Percentages of subjects||95% Confidence Interval|Number
758314|NCT00616421|Secondary|Geometric Mean Titers (hSBA), in Healthy Children 2 to 10 Years of Age.|The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the number of subjects with hSBA (human Serum Bactericidal Activity) Geometric Mean Titers (GMTs) response against N. meningitidis serogroups A, C, W-135, and Y.|1 month postvaccination|The analysis was performed on the per-protocol (PP) population.||Titers||95% Confidence Interval|Geometric Mean
758315|NCT00616421|Secondary|Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 10 Years of Age|"The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percentages of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y.
Seroresponse: For a subject with hSBA <1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline."|1 month postvaccination|The analysis was performed on the per-protocol (PP) population.||Percentage of subjects||95% Confidence Interval|Number
758316|NCT00616421|Primary|Percentages of Subjects With hSBA Seroresponse, in Healthy Children 6 to 10 Years of Age.|"The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percenatages of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y.
Seroresponse: For a subject with hSBA <1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline."|1 month postvaccination|The analysis was performed on the per-protocol (PP) population.||Percentages of subjects||95% Confidence Interval|Number
758317|NCT00616421|Secondary|Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 10 Years of Age.|"The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percentages of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y.
Seroresponse: For a subject with hSBA <1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline."|1 month postvaccination|The analysis was performed on the per-protocol (PP) population.||Percenatage of subjects||95% Confidence Interval|Number
758318|NCT00616421|Primary|Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age|"The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percentages of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y.
Seroresponse: For a subject with hSBA <1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline."|1 month postvaccination|The analysis was performed on the per-protocol (PP) population.||Percentages of subjects||95% Confidence Interval|Number
758319|NCT00616434|Secondary|Percentage of Participants With a Decrease on Simple Clinical Colitis Activity Index (SCCAI) of ≥3 Points at Week 8|The SCCAI measures disease activity as defined by both participants and examiners and includes the following 13 items: general well-being, abdominal pain, bowel frequency, stool consistency, bleeding, anorexia, nausea or vomiting, abdominal tenderness, extra-intestinal complications (eye, mouth, joint, skin), temperature, sigmoidoscopic assessment, nocturnal bowel movements, and urgency of defecation. Scores range from 0 to 19 points, and scores <2.5 have been shown to correlate with Patient-Defined Remission, and a decrease of >1.5 points from Baseline correlates with Patient-Defined Significant Improvement. Baseline is defined as the mean of the screening and visit 1 scores.|Baseline and Week 8|Intent-to-treat (ITT): Defined as all randomized participants who received at least one dose of study treatment for whom a baseline SCCAI ≥ 3 was available.||percentage of participants|||Number
758320|NCT00616434|Secondary|Number of Participants With Adverse Events (AEs)|An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE, can therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. All AE’s were analyzed based on the principle of treatment emergence. An AE was regarded as treatment-emergent if it was not present prior to receiving the first injection but subsequently appeared, or if it was present prior to receiving the first injection and subsequently worsened in severity.|Up to 16 weeks|Safety Population; participants who were randomized and received at least one dose of study treatment.||participants|||Number
760199|NCT00633867|Secondary|Quality of View of the Vocal Cords||At analysis||||||
758321|NCT00616434|Primary|Percentage of Participants With a Clinical Response|Clinical response is defined as a decrease from baseline in the total Mayo score of at least 3 points and at least 30%, accompanied by a decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore of 1 or less. Baseline was defined as the score collected during the screening period. The Mayo Score/Disease Activity Index (DAI) measures disease activity through assessment of 4 items: stool frequency, rectal bleeding, endoscopy findings, and Physician Global Assessment (PGA). Each item of the score is assessed on a 4-point scale, 0, 1, 2, or 3, with a higher score representing greater severity. In this study, the endoscopy subscore was expanded to a 5-point scale to increase sensitivity in this important dimension of the disease (0=normal/inactive disease, 4=deep ulceration). The Total Mayo Score can therefore range from 0 to13 points.|Baseline and Week 8|Intent-to-treat (ITT): Defined as all randomized participants who received at least one dose of study treatment for whom a baseline measure was available.||percentage of participants|||Number
758322|NCT00616577|Primary|Usage of Pain Medications||Over 24 hours|PI left institution and records cannot be located.|||||
758323|NCT00616603|Primary|Duration of Sciatic Nerve Block|Intraoperative opioid requirement PACU opioid requirement Floor opioid usage Time of onset of motor block (or weakness) Time of onset of sensory block Return of motor function Return of sensation Pain scores|from the time the block was placed up to 24 hours|PI left the institution and no analysis completed due to questionable data integrity|||||
758324|NCT00616629|Secondary|Number of Patients Who Had at Least One AE|Number of patients|During active treatment period|||Participants|||Number
758325|NCT00616629|Secondary|AUC Total of AZD1305 (Umol*h/L)|A total of 13 scheduled PK samples for each patient during and after infusion|Based on PK samples during and after infusion|||umol*h/L||Full Range|Mean
758326|NCT00616629|Secondary|Cmax Observed for AZD1305|A total of 13 scheduled PK samples for each patient during and after infusion|During and after infusion|||umol/L||Full Range|Mean
758327|NCT00616629|Secondary|QTcF (Interval From the Beginning of the Q or R Wave to the End of the T Wave in the Surface ECG, Corrected for Changes in RR Interval Using Fridericia’ Formula =QT/RR1/3 Interval in Seconds)|Absolute change, after - before infusion|Measurements were obtained twice, from the invasive electrophysiological measurements made before and 20 min (or more) after the start of administration of the investigational product. ECG measurements, including QTcF, are available from several additiona|||ms||Full Range|Mean
758328|NCT00616629|Secondary|VERP (Ventricular Effective Refractory Period)) and Other Electrophysiological and Electrocardiographic Variables; RR, P Wave Duration, PR, QRS, QTend, QTcF, QTtop, QTend - QTtop)|Absolute change, after - before infusion|Measurements were obtained twice, from the invasive electrophysiological measurements made before and 20 min (or more) after the start of administration of the investigational product|||ms||Full Range|Mean
758329|NCT00616629|Secondary|RAERP (Right Atrial Effective Refractory Period)|Absolute change, after - before infusion|Measurements were obtained twice, from the invasive electrophysiological measurements made before and 20 min (or more) after the start of administration of the investigational product|||ms||Full Range|Mean
758330|NCT00616629|Primary|LAERP (Left Atrial Effective Refractory Period (ie, the Longest S1-S2 Interval That Fails to Result in Atrial Depolarisation))|Absolute change, after - before infusion|Measurements were obtained twice, from the invasive electrophysiological measurements made before and 20 min (or more) after the start of administration of the investigational product|||ms||Full Range|Mean
758331|NCT00616642|Primary|Efficacy of Rosiglitazone Maleate on Cushing Disease|Reduction in pituitary tumor volume by over 50% as assessed by MRI to measurements made at baseline.|12 months|No data was analyzed for this outcome measure as there was insufficient data to perform analysis.|||||
758332|NCT00616655|Secondary|Change From Baseline Epworth Sleepiness Scale (ESS)|ESS was completed by the subject and assessed daytime sedation based on 8 items, each presenting a situation for which the subject needed to evaluate how likely he/she is to doze off or fall asleep in contrast to feeling just tired. Each item was evaluated on the following scale: 0 = would never doze; 1 = slight chance of dozing; 2 = moderate chance of dozing; 3 = high chance of dozing. ESS total score can range from 0 to 24, with higher scores indicating higher levels of daytime sleepiness.|Baseline, Weeks 2, 4, 6, 8, based on last observation carried forward (LOCF)|ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period.||units on a scale||Standard Deviation|Mean
758333|NCT00616655|Secondary|Change From Baseline Sheehan Disability Scale (SDS)|The SDS was completed by the subject and captured the subject’s level of disability. The subject rated the extent to which his or her work, social life or leisure activities, and home life or family responsibilities were impaired by his or her symptoms on a 10-point visual analog scale. SDS total score can range from 0 to 30, with higher scores indicating higher functional impairment.|Baseline, Weeks 2, 4, 6, 8, based on last observation carried forward (LOCF)|ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period.||units on a scale||Standard Deviation|Mean
758334|NCT00616655|Secondary|Change From Baseline Insomnia Severity Index (ISI) Total Score|The ISI was completed by the subject and is an assessment of the severity of insomnia. The administered extended ISI questionnaire consists of 5 items (containing 7 questions, as item 1 contains 3 questions) comprising the original ISI questionnaire, plus 6 quality of life related items (sleep quality, restedness/refreshness upon arising, daytime fatigue, attention/concentration, relationships and mood disturbances), and 2 items assessing duration and frequency of sleep problems. All items, except for the insomnia duration and frequency questions, are measured on a Likert-type 5-point scale (0-4). ISI total score can range from 0 to 28, with higher scores indicating more severe insomnia.|Baseline, Weeks 2, 4, 6, 8, based on lst observation carried forward (LOCF)|ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period.||units on a scale||Standard Deviation|Mean
758419|NCT00617240|Primary|Change From Baseline to Week 24 in Body Mass Index (BMI)|Change in BMI-Body Mass Index (BMI) is a measure of body fat based on height, weight,gender and chronological age. Change in BMI is calculated as 24 weeks BMI minus the baseline BMI.|0-24 weeks|All participants who took at least one dose of study treatment and had at least one post baseline assessment.||kg/m^2||Standard Error|Mean
758335|NCT00616655|Secondary|Change From Baseline on Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Short Form|The Q-LES-Q was completed by the subject and assessed quaility of life based on 16 items, each evaluated on a 5-point scale of overall level of enjoyment/satisfaction: 1=very poor; 2=poor; 3=fair; 4=good; 5=very good. The overall percentage score was computed as a sum of items 1 to 14 as expressed as a percentage of the maximum possible score: Overall Percentage Score = Sum [item 1... item 14]-14)/(70-14 ) *100%. Q-LES-Q overall percentage score can range from 0 to 100, with higher values indicating higher quality of life.|Baseline, Weeks 2, 4, 6, 8, based on last observation carried forward (LOCF)|ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period.||units on a scale||Standard Deviation|Mean
758336|NCT00616655|Secondary|Hamilton Anxiety Scale (HAM-A) Remission|"The HAM-A was administered by a site-trained rater and measured the severity of the subjects' anxiety symptoms using 14 items of the HAM-A rating scale. These items include: anxious mood, tension, fears, insomnia, intellectual, depressed mood, somatic complaints-muscular, somatic complaints-sensory, cardiovascular symptoms, respiratory symptoms, gastrointestinal symptoms, genitourinary symptoms, autonomic symptoms, and behavior at interview. All items are measured on a 5-point scale (0-4). Remission was defined as a HAM-A total score of 7 or less.
The Ham-A total score can range from 0 to 56 with higher scores indicating higher severity of anxiety symptoms."|Week 2, 4, 6, 8 based on last observation carried forward (LOCF)|ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period.||participants|||Number
758337|NCT00616655|Secondary|Hamilton Anxiety Scale (HAM-A) 50% Anxiolytic Response|"The HAM-A was administered by a site-trained rater and measured the severity of the subjects' anxiety symptoms using 14 items of the HAM-A rating scale. These items include: anxious mood, tension, fears, insomnia, intellectual, depressed mood, somatic complaints-muscular, somatic complaints-sensory, cardiovascular symptoms, respiratory symptoms, gastrointestinal symptoms, genitourinary symptoms, autonomic symptoms, and behavior at interview. All items are measured on a 5-point scale (0-4). A 50% anxiolytic response was defined as a 50% or greater reduction from baseline in the HAM-A total score.
The Ham-A total score can range from 0 to 56 with higher scores indicating higher severity of anxiety symptoms."|Week 2, 4, 6, 8|ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period.||participants|||Number
758338|NCT00616655|Secondary|Clinical Global Impression- Improvement (CGI-I)|"CGI-I was completed by a board certified psychiatrist and represented the clinician's subjective assessment of improvement of the subject's anxiety symptoms based on the following question, Compared to his/her condition at Visit 2, how much has he/she changed? The score was based on the following scale: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. CGI-I score can range from 0 to 7, with higher values indicating less improvement."|Weeks 2, 4, 6, 8, and 9, based on last observation carried forward (LOCF)|ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period.||units on a scale||Standard Deviation|Mean
758339|NCT00616655|Secondary|Change From Baseline in Clinician Global Impression of Severity (CGI-S)|"The CGI-Swas completed by a board certified psychiatrist and represents the clinician's subjective assessment of severity of the subject's anxiety symptoms as assessed by a 7-scale score for a single question, Considering your total clinical experience with this particular population, how anxious is the subject at this time? The score was based on the following scale: 1=normal, not at all anxious; 2=borderline anxious; 3=mildly anxious; 4=moderately anxious; 5=markedly anxious; 6=severly anxious; 7=among the most extremely anxious subjects. CGI-S score can range from 0 to 7, with higher values indicating higher severity."|Baseline, Weeks 2, 4, 6, 8, based on last observation carried forward (LOCF)|ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period.||units on a scale||Standard Deviation|Mean
758340|NCT00616655|Secondary|Change in Individual Item Scores on HAM-A|The HAM-A was administered by a site trained rater and measured the severity of the subjects' anxiety symptoms using 14 items of the HAM-A rating scale. These items include: anxious mood, tension, fears, insomnia, intellectual, depressed mood, somatic complaints-muscular, somatic complaints-sensory, cardiovascular symptoms, respiratory symptoms, gastrointestinal symptoms, genitourinary symptoms, autonomic symptoms, and behavior at interview. All items are measured on a t5-point scale (0-4). Each HAM-A individual item score can range from 0 to 4 with higher scores indicating higher severity of anxiety questions.|Baseline, Weeks 2, 4, 6, 8|ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period.||units on a scale||Standard Deviation|Mean
758341|NCT00616655|Secondary|Change From Baseline Hamilton Anxiety Scale (HAM-A) Total Score (Except for Week 8)|The HAM-A was administered by a site-trained rater and measured the severity of the subjects' anxiety symptoms using 14 items of the HAM-A rating scale. These items included: anxious mood, tension, fears, insomnia, intellectual, depressed mood, somatic complaints-muscular, somatic complaints-sensory, cardiovascular symptoms, respiratory symptoms, gastrointestinal symptoms, genitourinary symptoms, autonomic symptoms, and behavior at interview. all items are measured on a 5-point scale (0-4). Ham-A total score can range from 0 to 56 with higher scores indicating higher severity of anxiety symptoms.|Baseline, Weeks 2, 4, 6 based on last observation carried forward (LOCF)|ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period.||unit on a scale||Standard Deviation|Mean
758342|NCT00616655|Primary|Change From Baseline to Week 8 in the Total Score on the Hamilton Anxiety Scale (HAM-A), as Assessed by the Site-trained Rater|THe HAM-M was administered by a site-trained rater and measured the severity of the subjects' anxiety symptoms using 14 items of the HAM-M rating scale. These items included: anxious mood, tension, fears, insomnia, intellectual, depressed mood, somatic complaints-muscular, somatic complaints-sensory, cardiovascular symptoms, respiratory symptoms, gastrointestinal symptoms, genitourinary symptoms, autonomic symptoms, and behavior at interview. All items are measured on a 5-point scale (0-4). The Ham-A total score can range from 0 to 56 with higher scores indicating higher severity of anxiety symptoms.|Baseline to Week 8|ITT Population: /The ITT population will include all randomized subjects who received at least one does of study medication during the double-blind period.||Units on a scale||Standard Deviation|Mean
758345|NCT00616772|Secondary|Rate of Change in Composite of Mean of Maximal Posterior-wall and Anterior-wall Intima-media Thickness (IMT)|Rate of change (mm/year) from baseline in composite of mean of maximal posterior-wall and anterior-wall intima-media thickness (IMT) of the left and right common carotid artery, internal carotid artery, and carotid bifurcation. The statistical model used change from baseline as the dependent variable, with time of IMT assessment (in years) as one of the factors in the model. The between-group difference in the rate of change was based on the parameter coefficient for the time-by-treatment interaction. The within-group rate of change was obtained from estimate statements within the repeated measures analysis. IMT was measured using non-invasive ultrasound.|Baseline, 6 months, 12 months, 18 months, and 24 months|All randomized subjects who had both a baseline value and at least 1 postbaseline value for that parameter, as well as 6 or more matching segments at baseline and the 2-year visit. Observations at the interim visits were included only if 6 or more segments matched the segments at baseline and at 2 years.||mm/year||Standard Error|Mean
758346|NCT00616772|Secondary|Rate of Change in Composite of Mean of Maximal Posterior-wall Intima-media Thickness (IMT)|Rate of change (mm/year) from baseline in composite of mean of maximal posterior-wall intima-media thickness (IMT) of the left and right common carotid artery, internal carotid artery, and carotid bifurcation. The statistical model used change from baseline as the dependent variable, with time of IMT assessment (in years) as one of the factors in the model. The between-group difference in the rate of change was based on the parameter coefficient for the time-by-treatment interaction. The within-group rate of change was obtained from estimate statements within the repeated measures analysis. IMT was measured using non-invasive ultrasound.|Baseline, 6 months, 12 months, 18 months, and 24 months|All randomized subjects who had both a baseline value and at least 1 postbaseline value for that parameter, as well as 3 or more matching segments at baseline and the 2-year visit. Observations at the interim visits were included only if 3 or more segments matched the segments at baseline and at 2 years.||mm/year||Standard Error|Mean
758347|NCT00616772|Secondary|Rate of Change in Composite of Mean of the Mean Posterior-wall Intima-media Thickness (IMT)|Rate of change (mm/year) from baseline in composite of mean of the mean posterior-wall intima-media thickness (IMT) of the left and right common carotid artery, internal carotid artery, and carotid bifurcation. The statistical model used change from baseline as the dependent variable, with time of IMT assessment (in years) as one of the factors in the model. The between-group difference in the rate of change was based on the parameter coefficient for the time-by-treatment interaction. The within-group rate of change was obtained from estimate statements within the repeated measures analysis. IMT was measured using non-invasive ultrasound.|Baseline, 6 months, 12 months, 18 months, and 24 months|All randomized subjects who had both a baseline value and at least 1 postbaseline value for that parameter, as well as 3 or more matching segments at baseline and the 2-year visit. Observations at the interim visits were included only if 3 or more segments matched the segments at baseline and at 2 years.||mm/year||Standard Error|Mean
758348|NCT00616772|Secondary|Rate of Change in Mean of Maximal Posterior-wall Carotid Intima-media Thickness (cIMT)|Rate of change (mm/year) from baseline in mean of maximal posterior-wall carotid intima-media thickness (cIMT) of the left and right common carotid artery. The statistical model used change from baseline as the dependent variable, with time of cIMT assessment (in years) as one of the factors in the model. The between-group difference in the rate of change was based on the parameter coefficient for the time-by-treatment interaction. The within-group rate of change was obtained from estimate statements within the repeated measures analysis. cIMT was measured using non-invasive ultrasound.|Baseline, 6 months, 12 months, 18 months, and 24 months|All randomized subjects who had both a baseline value and at least 1 postbaseline value for that parameter.||mm/year||Standard Error|Mean
758349|NCT00616772|Primary|Rate of Change in Mean Posterior-wall Carotid Intima-media Thickness (cIMT)|Rate of change (mm/year) from baseline in mean of posterior-wall carotid intima-media thickness (cIMT) of the left and right common carotid artery. The statistical model used change from baseline as the dependent variable, with time of cIMT assessment (in years) as one of the factors in the model. The between-group difference in the rate of change was based on the parameter coefficient for the time-by-treatment interaction. The within-group rate of change was obtained from estimate statements within the repeated measures analysis. cIMT was measured using non-invasive ultrasound.|Baseline, 6 months, 12 months, 18 months, and 24 months|All randomized participants who had both a baseline value and at least 1 postbaseline value for that parameter.||mm/year||Standard Error|Mean
758350|NCT00616902|Secondary|Change From Baseline in Biological Marker Plasma B-Type Natriuretic Peptide (BNP)|Plasma BNP is a product from the heart that becomes elevated with an enlarged heart and its level may be affected by treatment with paricalcitol. The study was terminated early (prior to any subject reaching Week 24). The values are for Baseline and Early Termination only. Each of the 12 randomized subjects terminated at different study weeks; therefore Early Termination cannot be defined as a specific week and varies for different subjects. Of the 12 subjects, 11 had early termination visits and 1 didn't. The final visit week range is 4-16.|Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks)|The Intent-To-Treat (ITT) population - all randomized participants administered at least one dose of study drug. Results reported are from the early termination visit analysis for the subjects who terminated prematurely. None of the participants completed 24 or 48 weeks.||ng/L||Standard Deviation|Mean
758351|NCT00616902|Secondary|Change From Baseline in Biological Marker Plasma High Sensitivity C-reactive Protein (hsCRP) Over 48 Weeks|Plasma high sensitivity CRP is a biomarker of inflammation that may have an effect on heart function and its level may be affected by treatment with paricalcitol. The study was terminated early (prior to any subject reaching Week 24). The values are for Baseline and Early Termination only. Each of the 12 randomized subjects terminated at different study weeks; therefore Early Termination cannot be defined as a specific week and varies for different subjects. Of the 12 subjects, 11 had early termination visits and 1 didn't. The final visit week range is 4-16.|Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks)|The Intent-To-Treat (ITT) population - all randomized participants administered at least one dose of study drug. Results reported are from the early termination visit analysis for the subjects who terminated prematurely. None of the participants completed 24 or 48 weeks.||mg/L||Standard Deviation|Mean
758416|NCT00617240|Secondary|Change From Baseline to Week 24 in Insulin Level|Insulin is a peptide hormone and regulates carbohydrate and fat metabolism in the body.Change in Insulin level is calculated as the 24 weeks insulin level minus the baseline insulin level.|24 weeks|Only participants with complete data on insulin levels at both baseline and 24 weeks were utilized.||microIU/ml||Standard Error|Mean
758352|NCT00616902|Secondary|Change From Baseline in Biological Marker Plasma Interleukin-6 (IL-6) Over 48 Weeks|Plasma IL-6 is a biomarker of inflammation that may have an effect on heart function and its level may be affected by treatment with paricalcitol. The study was terminated early (prior to any subject reaching Week 24). The values are for Baseline and Early Termination only. Each of the 12 randomized subjects terminated at different study weeks; therefore Early Termination cannot be defined as a specific week and varies for different subjects. Of the 12 subjects, 11 had early termination visits and 1 didn't. The final visit week range is 4-16.|Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks)|The Intent-To-Treat (ITT) population - all randomized participants administered at least one dose of study drug. Results reported are from the early termination visit analysis for the subjects who terminated prematurely. None of the participants completed 24 or 48 weeks.||cm/sec||Standard Deviation|Mean
758353|NCT00616902|Secondary|Change From Baseline in Biological Marker Plasma Troponin-T Over 48 Weeks|Plasma troponin-t is a marker of heart damage and and its level may be affected by treatment with paricalcitol. The study was terminated early (prior to any subject reaching Week 24). The values are for Baseline and Early Termination only. Each of the 12 randomized subjects terminated at different study weeks; therefore Early Termination cannot be defined as a specific week and varies for different subjects. Of the 12 subjects, 11 had early termination visits and 1 didn't. The final visit week range is 4-16.|Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks)|The Intent-To-Treat (ITT) population - all randomized participants administered at least one dose of study drug. Results reported are from the early termination visit analysis for the subjects who terminated prematurely. None of the participants completed 24 or 48 weeks.||mcg/L||Standard Deviation|Mean
758354|NCT00616902|Secondary|Change From Baseline in Biological Marker Triiodothyronine (T3).|Plasma T3 is a circulating hormone that may have an effect on diastolic heart function and its level may be affected by treatment with paricalcitol. The study was terminated early (prior to any subject reaching Week 24). The values are for Baseline and Early Termination only. Each of the 12 randomized subjects terminated at different study weeks; therefore Early Termination cannot be defined as a specific week and varies for different subjects. Of the 12 subjects, 11 had early termination visits and 1 didn't. The final visit week range is 4-16.|Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks)|The Intent-To-Treat (ITT) population - all randomized participants administered at least one dose of study drug. Results reported are from the early termination visit analysis for the subjects who terminated prematurely. None of the participants completed 24 or 48 weeks.||nmol/L||Standard Deviation|Mean
758355|NCT00616902|Secondary|Change From Baseline in Evaluating Changes in the Additional Measure of Diastolic Function E-wave Deceleration Time (DT) Over 48 Weeks|E-wave deceleration time is a measure of diastolic heart function.|Baseline, 24 Weeks, and 48 Weeks/Early Termination|The Intent-To-Treat (ITT) population - all randomized participants who were administered at least one dose of study drug. None of the participants completed 24 or 48 weeks.||sec||Standard Deviation|Mean
758356|NCT00616902|Secondary|Change From Baseline in Evaluating Changes in the Additional Measure of Diastolic Function of Peak E-wave Velocity to Lateral E-wave Velocity (E/E') Over 48 Weeks.|The ratio of peak E-wave velocity to lateral e-wave velocity is a measure of diastolic heart function.|Baseline, Week 24, and Week 48/Early Termination|The Intent-To-Treat (ITT) population - all randomized participants who were administered at least one dose of study drug. None of the participants completed 24 or 48 weeks.||cm/sec||Standard Deviation|Mean
758357|NCT00616902|Secondary|Change From Baseline in Evaluating Changes in the Additional Measure of Diastolic Function of Isovolumetric Relaxation Time (IVRT) Over 48 Weeks.|Isovolumetric relaxation time is a measure of diastolic heart function.|Baseline, 24 Weeks, and 48 Weeks/Early Termination|The Intent-To-Treat (ITT) population - all randomized participants who were administered at least one dose of study drug. None of the participants completed 24 or 48 weeks.||sec||Standard Deviation|Mean
758358|NCT00616902|Primary|Change From Baseline in Left Ventricular Mass Index (LVMI) Over 48 Weeks Measured by Cardiac Magnetic Resonance Imaging (MRI)|"Change from Baseline in left ventricular mass index (LVMI) over 48 weeks measured by cardiac MRI. The effects of paricalcitol injection on progression or regression of left ventricular hypertrophy (LVH) in participants with Stage 5 chronic kidney disease (CKD) on hemodialysis (HD) compared to placebo. Left Ventricular Mass is normalized to the participant's height by the following equation to obtain LVMI: LVM (g) divided by height (m)2.7.
The primary comparison was between the 4 mcg paricalcitol injection and the placebo treatment groups in the change from baseline to Week 48."|Baseline, 24 Weeks, and 48 Weeks/Early Termination|The Intent-To-Treat (ITT) population - all randomized participants who were administered at least one dose of study drug and the Evaluable population (a subset of ITT population and consists of those participants who have completed Week 24 visit). None of the participants completed 24 or 48 weeks.||g/m2.7||Standard Deviation|Mean
758359|NCT00616902|Secondary|Change From Baseline in the Echocardiographic Assessment of Diastolic Function Assessed by Evaluating Changes in Diastolic Mitral Annular Relaxation Velocity (E') Over 48 Weeks.|Mitral Annular relaxation velocity is a measure of diastolic heart function.|Baseline, 24 Weeks, and 48 Weeks/Early Termination|The Intent-To-Treat (ITT) population - all randomized participants who were administered at least one dose of study drug. None of the participants completed 24 or 48 weeks.||cm/sec||Standard Deviation|Mean
758360|NCT00616928|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1) as Assessed by Microneutralization Assays|Titers were expressed as Geometric Mean Titers (GMTs).|At Day 0 and Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)|The analysis was based on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects (meeting all eligibility criteria, complying with the procedures in the protocol, with no elimination criteria during the study) with available data.||Titers||95% Confidence Interval|Geometric Mean
758361|NCT00616928|Secondary|Number of Subjects With a Vaccine Response to the Vaccine-homologous Virus and Drift Variant H5N1 Virus, as Assessed by Microneutralization Assays.|Virus antibody response rates were defined as the number of subjects with antibody titers at Day 42 ≥ 4-fold the pre-vaccination antibody titers. The 2 strains assessed were Flu A/Indonesia/5/05 and Flu A/Vietnam/1194/04.|At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)|The analysis was based on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects (meeting all eligibility criteria, complying with the procedures in the protocol, with no elimination criteria during the study) with available data.||Subjects|||Number
758362|NCT00616928|Secondary|Titers for Serum HI Antibodies Against A/Indonesia/5/05 (H5N1)|Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10.|At Month 6 (Day 182) after Dose 1|The analysis was based on the ATP cohort for analysis of immunogenicity - Month 6, which included all evaluable subjects (meeting all eligibility criteria, complying with the procedures in the protocol, with no elimination criteria during the study) with a complete set of data concerning immunogenicity primary outcome variables at Month 6.||Titers||95% Confidence Interval|Geometric Mean
758363|NCT00616928|Secondary|Number of Seroprotected Subjects Against A/Indonesia/5/2005 (H5N1)||At Month 6 (Day 182) after Dose 1|The analysis was based on the ATP cohort for analysis of immunogenicity - Month 6, which included all evaluable subjects (meeting all eligibility criteria, complying with the procedures in the protocol, with no elimination criteria during the study) with a complete set of data concerning immunogenicity primary outcome variables available at Month 6||Subjects|||Number
758364|NCT00616928|Secondary|Number of Seroconverted Subjects Against A/Indonesia/5/2005 (H5N1)|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) reciprocal HI titer < 1:10 and a post-vaccination (Day 42) reciprocal titer ≥ 1:40, or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a 4-fold increase in post-vaccination reciprocal titer against A/Indonesia/5/05 virus 21 days after the second dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted.|At Month 6 (Day 182) after Dose 1|The analysis was based on the ATP cohort for analysis of immunogenicity - Month 6, which included all evaluable subjects (meeting all eligibility criteria, complying with the procedures in the protocol, with no elimination criteria during the study) with a complete set of data concerning immunogenicity primary outcome variables available at Month 6||Subjects|||Number
758365|NCT00616928|Secondary|Number of Subjects With A/Indonesia/5/05 Antibody Titers ≥ 1:10||At Month 6 (Day 182) post Dose 1|The analysis was based on the ATP cohort for analysis of immunogenicity - Month 6, which included all evaluable subjects (meeting all eligibility criteria, complying with the procedures in the protocol, with no elimination criteria during the study) with a complete set of data concerning immunogenicity primary outcome variables available at Month 6||Subjects|||Number
758366|NCT00616928|Secondary|Number of Subjects With Serum Reciprocal HI Antibodies Against A/Indonesia/5/2005 Equal to or Above (≥) 1:10||At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)|The analysis was based on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects (meeting all eligibility criteria, complying with the procedures in the protocol, with no elimination criteria during the study) with a complete set of data concerning immunogenicity primary outcome variables available.||Subjects|||Number
758367|NCT00616928|Primary|Number of Subjects With Medically Attended Events (MAEs)||From Day 0 through Day 182 and through Day 364.|||Subjects|||Number
758368|NCT00616928|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Day 0 through Day 182 and through Day 379.|||Subjects|||Number
758369|NCT00616928|Primary|Number of Subjects With Any Unsolicited Adverse Events (AEs).|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During a 21-day follow-up period for each vaccine administration, as well as overall (Day 0 through Day 84)|||Subjects|||Number
758370|NCT00616928|Primary|Number of Subjects With Any Solicited General Symptoms.|Assessed solicited general symptoms were fatigue, headache, joint pain at other locations, muscle aches, shivering, sweating and temperature[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade.|During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccine administration|The analysis was based on the Total Vaccinated cohort, on subjects with symptom sheets completed.||Subjects|||Number
758371|NCT00616928|Primary|Number of Subjects With Any Solicited Local Symptoms.|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.|During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccine administration|The analysis was based on the Total Vaccinated cohort, on subjects with symptom sheets completed.||Subjects|||Number
758372|NCT00616928|Primary|Number of Seroprotected Subjects Against A/Indonesia/5/2005 (H5N1)|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.|At Day 0 and Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)|The analysis was based on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects (meeting all eligibility criteria, complying with the procedures in the protocol, with no elimination criteria during the study) with a complete set of data concerning immunogenicity primary outcome variables available.||Subjects|||Number
758373|NCT00616928|Primary|Number of Seroconverted Subjects Against A/Indonesia/5/2005 (H5N1)|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) reciprocal HI titer < 1:10 and a post-vaccination (Day 42) reciprocal titer ≥ 1:40, or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a 4-fold increase in post-vaccination reciprocal titer against A/Indonesia/5/05 virus 21 days after the second dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted.|At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)|The analysis was based on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects (meeting all eligibility criteria, complying with the procedures in the protocol, with no elimination criteria during the study) with a complete set of data concerning immunogenicity primary outcome variables available.||Subjects|||Number
758374|NCT00616967|Secondary|Baseline and Change in Continuous Variables (e.g., Candidate Gene Methylation, Expression Profiles, Tissue, and Peripheral Blood Mononuclear Cell Histone Acetylation)||Time of breast cancer surgery||||||
758375|NCT00616967|Secondary|Long Term Outcomes||Indefinite survival analysis||||||
758376|NCT00616967|Secondary|Baseline and Change in Markers of Apoptosis and Proliferation||Time of breast cancer surgery||||||
760200|NCT00633867|Secondary|Difference in Learning to Use the Scopes|Is there a difference between trainee anaesthetists in learning to use the scopes|At analysis||||||
758377|NCT00616967|Secondary|Standard Uptake Values as Measured by Baseline and Changes (Day 15) on FDG-PET|The standard uptake value used for the PET analysis was SULmax, which is the standard uptake value normalized for lean body mass.|Baseline and day 15|"Of the 17 responders from the primary outcome measure, 16 participants had PET data evaluable for analysis. Of the 45 non-responders from the primary outcome measure, 43 participants had PET data evaluable for analysis."||percentage of change in SULmax||Full Range|Median
758378|NCT00616967|Secondary|Clinical Complete Response (cCR) Rate||Time of breast cancer surgery||||||
758379|NCT00616967|Secondary|Safety as Measured by NCI CTCAE Version 3.0||Active treatment until 30 days post-treatment||||||
758380|NCT00616967|Primary|Pathological Complete Response (pCR) Rate|The primary end point was pCR, defined as no viable invasive cancer in breast and axilla. All other cases were defined as non-pCR. The pCR rate was determined in each arm separately by performing an intent-to-treat (ITT) analysis of all randomized patients. Patients with unknown pCR status were considered non-responders. Computation of associated 90% confidence intervals did not account for the sequential design.|Time of breast cancer surgery|"The information for the primary populations for analysis are included (Placebo and Vorinostat arms). The initial run-in phase of 6 participants was conducted to confirm safety and dosing for the combination of vorinostat with chemotherapy only, and these data are not a part of our primary study analyses."||participants|||Number
758381|NCT00617058|Secondary|Percent Change in LDL||24 weeks|||percent change|||Number
758382|NCT00617058|Secondary|Percent Change in HDL||24 weeks|||percent change|||Number
758383|NCT00617058|Secondary|Percent Change in Glucose Levels||24 weeks|||percent change|||Number
758384|NCT00617058|Primary|Percent Change in Weight||24 weeks|||percent change|||Number
758385|NCT00617058|Secondary|Incidence of Metabolic Syndrome||24 weeks|||participants|||Number
758386|NCT00617058|Secondary|Percent Change in Triglycerides||24 weeks|||percent change|||Number
758387|NCT00617058|Secondary|Percent Change in Total Cholesterol||24 weeks|||percent change|||Number
758388|NCT00617058|Secondary|Percent Change in Insulin Levels||24 weeks|||percent change|||Number
758389|NCT00617058|Primary|Percent Change in Fat Mass||24 weeks|||percent change|||Number
758390|NCT00617058|Primary|Absolute Change in Weight||24 weeks|||lbs.|||Number
758391|NCT00617058|Primary|Percent Change in BMI||24 weeks|This research study only enrolled a single study participant before the entire research study was terminated due to the start of a larger, multi-site trial evaluating similar outcome measures.||percent change|||Number
758392|NCT00617084|Secondary|In-Stent Percent Diameter Stenosis|In Stent Percent Diameter Stenosis at thirteen months. In Stent Percent Diameter Stenosis: measured percent of diameter stenosis at the region of the stent (calculated as 100x(RVD-MLD)/RVD using the mean values from 2 orthogonal views by QCA. RVD (Reference Vessel Diameter): average of normal segments within 10mm proximal and distal to target lesion from 2 orthogonal views using QCA. MLD (Minimal Lumen Diameter): average of 2 orthogonal views of the narrowest point wihtin the area of assessment. MLD measured during QCA by the angiographic core laboratory.|13 Months|||Percentage diameter stenosis||Standard Deviation|Mean
758393|NCT00617084|Primary|Target Lesion Failure|Percentage of participants that had either Cardiac Death, Myocardial Infarction (not clearly attributable to a non-target vessel)or Target Lesion Revascularization (TLR, clinically indicated) after one year. MI: Q MI if new pathological Q waves and chest pain, non Q MI if CK elevated more than two times normal, troponin elevated more than normal, according to ARC definitions. TLR, clinically indicated if associated with ischemic symptoms and angiographic min lumen diameter bigger than fifty percent by QCA or without symptoms and min lumen diameter bigger than seventy percent. Measure average.|12 months|Analysis per intention to treat||percentage of participants|||Number
758394|NCT00617097|Secondary|Complications||end of study|||participants|||Number
758395|NCT00617097|Secondary|Reported Symptoms|fever, chills, vomiting, heavy bleeding/clots (collected without regard to the specific event)|end of study (upon discharge from facility after procedure)|||participants|||Number
758396|NCT00617097|Secondary|Visual Analogue Scale Regarding Satisfaction Level|100-mm Visual Analogue Scale -- minimum: 0 mm (lower satisfaction), maximum: 100 mm (greater satisfaction)|end of study (prior to clinic discharge)|||mm||Standard Deviation|Mean
758397|NCT00617097|Primary|Level of Pain During Specific Time Intervals Throughout D&C Procedure.|"100-mm Visual Analogue Scale (VAS) during specific time intervals of D&C procedure: minimum: 0 mm (less pain); maximum: 100 mm (more pain)
Time intervals include: basline expected level of pain during procedure, after speculum insertion, at paracervical block injection, after dilation, end of procedure, and 30 minutes after procedure."|Baseline, Speculum Insertion, at Paracervical block injection, After dilation, End of procedure, 30 minutes after procedure|||mm||Standard Deviation|Mean
758398|NCT00617123|Secondary|Change From Baseline in the Numerical Score of Graded Abnormalities as Measured by Fundus Photography|Individual fundus photography abnormalities were scored as 0=not present or 1=present. The total number of possible abnormalities present was 48 (24 possible abnomalities per eye). Data are for the left and right eyes combined (score range: 0 to 48). Change from Baseline at a given timepoint was calculated as Timepoint Score minus Baseline Score. A smaller score indicates fewer graded abnormalities.|Baseline and 4, 8 and 12 months|The analysis population consisted of all participants who took at least one dose of study medication, and had a baseline and at least one post-baseline numerical score of graded abnormalities assessment as measured by fundus photogrpahy.||score on a scale||Standard Error|Mean
758399|NCT00617123|Secondary|Change From Baseline in the Numerical Score of Graded Abnormalities as Measured by OCT|Individual OCT abnormalities were scored as 0=not present or 1=present. The total number of possible abnormalities present was 84 (42 possible abnormalities per eye). Data are for the left and right eyes combined (score range: 0 to 84). Change from Baseline at a given timepoint was calculated as Timepoint Score minus Baseline Score. A smaller score indicates fewer graded abnormalities.|Baseline and 4, 8 and 12 months|The analysis population consisted of all participants who took at least one dose of study medication, and had a baseline and at least one post-baseline numerical score of graded abnormalities assessment by OCT.||score on a scale||Standard Error|Mean
758417|NCT00617240|Primary|Change From Baseline to Week 24 in Fat Mass|Fat mass is a measure of excess body fat. Change in Fat Mass is calculated as 24 weeks fat mass minus the baseline fat mass.|24 weeks|Only participants with complete data on fat mass at both baseline and 24 weeks were utilized.||kg||Standard Error|Mean
758400|NCT00617123|Secondary|Number of Participants With Change From Baseline of Center Foveal Thickness of Greater Than 15 Microns as Measured by OCT|Center foveal thickness measured by OCT was evaluated for a change from baseline in greater than 15 microns in either the left or right eye.|Baseline and 4, 8 and 12 months|The analysis population consisted of all participants who took at least one dose of study medication, and had a baseline and at least one post-baseline center point thickness assessment by OCT.||participants|||Number
758401|NCT00617123|Secondary|Number of Participants Who Have a Decrease in Visual Acuity Score of at Least Seven Letters From Baseline|Visual acuity was assessed in both eyes by best corrected visual acuity following standardized refraction. The best corrected visual acuity score is the number of letters on a standard visual acuity testing chart read correctly by a participant. A decrease in best corrected visual acuity score in the left and/or right eye indicates a worsening of vision.|Baseline and 4, 8 and 12 months|The analysis population consisted of all participants who took at least one dose of study medication, and had a baseline and at least one post-baseline visual acuity score.||participants|||Number
758402|NCT00617123|Primary|Number of Participants Who Develop Vacuolization in the Inner Nuclear Layer (INL) of the Retina as Measured by Ocular Coherence Tomography (OCT)|Vacuolization is defined as the presence of more than one vacuole (defined as a clear, round structure in the INL of the retina of at least 30 microns in diameter) compared to baseline in either the left or right eye as evaluated by ocular coherence tomography (OCT).|Up to 12 months|The analysis population consisted of all participants who took at least one dose of study medication, and had a baseline and at least one post-baseline vacuolation assessment.||participants|||Number
758403|NCT00617175|Secondary|Evaluate the Percent Reduction in the Number of Shocks Delivered Per Subject for Treating Spontaneous Episodes With a Fast Cycle Length (CL < 320 ms) and for Spontaneous Ventricular Episodes.||end of study||||||
758404|NCT00617175|Primary|For the Primary Endpoint the Reduction of Ventricular Therapies (ATP and Shocks) Delivered for Treating Fast Spontaneous Arrhythmia Episodes Was Measured.|"for each patient, the exposure time was calculated as the period between randomization and until study completion or exit whichever occured first. Exposure times for all patients were then summed.
The rate of therapies was calculated as the sum of all therapies delivered in the study (for each arm) over the sum of exposure times * 100."|From enrollment to study completion or exit whichever occured first|For the primary endpoint analysis, only patients with at least a device data record were considered.||rate of therapies per 100 patient-years||95% Confidence Interval|Number
758405|NCT00617188|Secondary|Urine N-telopeptide Concentration|Median bone mineral results - assessed by serial urine N-telopeptide laboratory results collected from patients.|Baseline, 1 Month, 3 Months, 6 Months|||Units of Bone Collagen Equivalents/mmol||Full Range|Median
758406|NCT00617188|Primary|Patients' Overall 90-Day Clinical Response as Measured by Response Evaluation Criteria in Solid Tumors (RECIST)|Best response recorded from the start of treatment until Day 90. Defined by the sum of the Complete Responses (CR), Partial Responses (PR) and Stable Disease (SD) in patients treated with fulvestrant. CR=disappearance of all lesions, PR=>or =30% decrease in sum of all target lesions, Progressive Disease (PD) =>or=20% increase in sum of all target or any new lesions, SD=not CR, PR or PD.|Day 90|||Participants|||Number
758407|NCT00617188|Secondary|Serum Skeletal-Specific Alkaline Phosphatase Concentration|Median Bone mineral results - assessed by serum skeletal-specific alkaline phosphatase laboratory results collected from patients in study.|Baseline, 1 Month, 3 Months, 6 Months|||Units/Liter||Full Range|Median
758408|NCT00617188|Secondary|Mean Scores - Quality of Life Assessment|Functional Assessment of Cancer Therapy-Ovarian Cancer (FACT-O)Version 1/23/07 - This is a relative quality of life assessment; 100 = Best, 0 = Worst. It was developed and validated with cancer patients and includes physical well being, social well being, emotional well being and relationship with doctor subscales and can be summed into one total quality of life score. It is a standardized scale which collects data (scores 1-4) from 47 questions. Answers are transformed into a number between 0-100. Mean was calculated by adding up the values of the scores and dividing by the number of scores.|Baseline, 3 Months Post Treatment, 6 Months Post Treatment|||Scores on a Scale||Full Range|Mean
758409|NCT00617188|Secondary|Median Number of Days to Treatment Termination|Time is determined from first dose to termination due to all causes.|Up to 373 Days|||Days||Full Range|Median
758410|NCT00617188|Secondary|Patients' Overall 90-Day Clinical Response as Measured by Modified Response Evaluation Criteria in Solid Tumors (Rustin)|Defined by the sum of Complete Responses (CR), Partial Responses (PR) and Stable Disease (SD) in patients treated with fulvestrant. CR=normalization of serum CA-125 level from 2 initially elevated samples, PR=>or=50% decrease in serum CA-125 level from 2 initially elevated samples, Progressive Disease (PD)=CA-125 two times the upper limit of normal on 2 occasions (if previously normalized) OR CA-125 two times nadir (lowest value) on 2 occasions if elevated at initiation of treatment, SD=not CR, PR or PD.|Day 90|||Participants|||Number
758411|NCT00617201|Secondary|Retention|Trial retention- those who complete the 12 week dosing period|12-weeks|those completing the 12-week study after randomization||days||Standard Error|Mean
758412|NCT00617201|Primary|% Urine Samples Negative for Cocaine|Total % urine samples negative for benzoylecgonine over the 12-week trial|Urines were collected 3 times per week (e.g., Monday, Wednesday and Friday) for 12 weeks|Intent-to-treat analysis included all subjects with missing urine sample counted as positive.||percentage of positive urine samples|Urine samples||Number
758413|NCT00617240|Secondary|Incidence of Metabolic Syndrome|Metabolic syndrome is a combination of the medical disorders that, when co-occurring, increase the risk of developing cardiovascular disease and diabetes.|24 weeks|||participants|||Number
758414|NCT00617240|Secondary|Change From Baseline to Week 24 in Triglycerides|In the human body, high levels of triglyceride fats in the bloodstream have been linked to atherosclerosis and, by extension, the risk of heart disease and stroke. A change in triglycerides is calculated from 24 weeks minus baseline levels.|24 weeks|Only participants with complete data on triglyceride levels at both baseline and 24 weeks were utilized.||mg/dl||Standard Error|Mean
758415|NCT00617240|Secondary|Change From Baseline to Week 24 in Cholesterol Level|According to the lipid hypothesis, abnormal cholesterol levels are strongly associated with cardiovascular disease because these promote atherosclerosis.Cholesterol levels are measured in milligrams (mg) of cholesterol per deciliter(dL) of blood.Change in cholesterol levels is measured at 24 weeks minus the levels at baseline.|24 weeks|Only participants with complete data on cholesterol levels at both baseline and 24 weeks were utilized.||mg/dl||Standard Error|Mean
758420|NCT00617279|Secondary|Change in Quality of Life as Evaluated by the SF-36v2® Health Survey From Baseline Through One Month Post-procedure|The SF-36v2 Health Survey asks 36 questions to measure health and well-being from the patient's point of view. The responses to these questions can be presented as physical component summary and mental component summary scores. An increase in score from baseline indicates an improvement in the patient's condition and a decrease in score from baseline indicates a decline in the patient's condition. The subscale and total score ranges from 0 to 100 but is normalized so that a score of 50 is the population mean, with a standard deviation of 10.|One month|The number of patients analyzed at 1 month does not equal the number of patients originally enrolled into the study, due to the fact that a number of enrolled patients did not have (or failed to attend) their 1 month follow-up visit prior to the termination of the study.||scores on a scale||Standard Deviation|Mean
758421|NCT00617279|Secondary|Number of Patients With Delayed Wound Healing Through 12 Months Post-procedure|Delayed wound healing was not specifically defined in the protocol and was left to the Investigator's standard of care.|12 months|||Participants|||Number
758422|NCT00617279|Secondary|Number of Patients With Delayed Wound Healing Through 6 Months Post-procedure|Delayed wound healing was not specifically defined in the protocol and was left to the Investigator's standard of care.|6 months|||Participants|||Number
758423|NCT00617279|Secondary|Number of Patients With Delayed Wound Healing Through One Month Post-procedure|Delayed wound healing was not specifically defined in the protocol and was left to the Investigator's standard of care.|One month|||Participants|||Number
758424|NCT00617279|Secondary|Number of Patients With Wound/Graft Infection Through 12 Months|Wound/graft infection was not specifically defined in the protocol and was left to the Investigator's standard of care.|12 months|||Participants|||Number
758425|NCT00617279|Secondary|Number of Patients With Wound/Graft Infection Through 6 Months|Wound/graft infection was not specifically defined in the protocol and was left to the Investigator's standard of care.|6 months|||Participants|||Number
758426|NCT00617279|Secondary|Number of Patients With Wound/Graft Infection Through One Month Post-procedure|Wound/graft infection was not specifically defined in the protocol and was left to the Investigator's standard of care.|One month|||Participants|||Number
758427|NCT00617279|Secondary|Number of Patients Surviving at 12 Months||12 months|||Participants|||Number
758428|NCT00617279|Secondary|Number of Patients Surviving at 6 Months||6 months|||Participants|||Number
758429|NCT00617279|Secondary|Number of Patients Surviving at One Month||One month|||Participants|||Number
758430|NCT00617279|Secondary|Patients Experiencing Major Adverse Events Through 12 Months Post-procedure|A major adverse event requires significant therapy, including unplanned increase in the level of care, permanent sequelae, hospitalization, or death.|12 months|||Participants|||Number
758431|NCT00617279|Secondary|Patients Experiencing Major Adverse Events Through 6 Months Post-procedure|A major adverse event requires significant therapy, including unplanned increase in the level of care, permanent sequelae, hospitalization, or death.|6 months|||Participants|||Number
758432|NCT00617279|Secondary|Number of Patients With Limb Salvage (no Major Amputations) at 12 Months Post-procedure|Limb salvage is defined as relief from symptoms sufficient to prevent major amputation. An amputation is considered to be major when there is surgical removal of a portion of the study leg that would preclude standing and walking without a prosthesis.|12 months|||Participants|||Number
758433|NCT00617279|Secondary|Number of Patients With Limb Salvage (no Major Amputations) at 6 Months Post-procedure|Limb salvage is defined as relief from symptoms sufficient to prevent major amputation. An amputation is considered to be major when there is surgical removal of a portion of the study leg that would preclude standing and walking without a prosthesis.|6 months|||Participants|||Number
758434|NCT00617279|Secondary|Number of Patients With Limb Salvage (no Major Amputations) at One Month Post-procedure|Limb salvage is defined as relief from symptoms sufficient to prevent major amputation. An amputation is considered to be major when there is surgical removal of a portion of the study leg that would preclude standing and walking without a prosthesis.|One month|||Participants|||Number
758435|NCT00617279|Secondary|Number of Patients With Secondary Patency at 12 Months|Secondary patency is defined as hemodynamic evidence of blood flow through an open graft that has previously undergone revision(s) to restore blood flow after occlusion.|12 months|The number of patients analyzed at 12 months post-procedure does not equal the number of patients originally enrolled into the study. This is due to the fact that a number of enrolled patients did not have their 12 month follow-up visit (or failed to attend their 12 month visit) prior to the termination of the study.||Participants|||Number
758436|NCT00617279|Secondary|Number of Patients With Secondary Patency at 6 Months|Secondary patency is defined as hemodynamic evidence of blood flow through an open graft that has previously undergone revision(s) to restore blood flow after occlusion.|6 months|The number of patients analyzed at 6 months post-procedure does not equal the number of patients originally enrolled into the study. This is due to the fact that a number of enrolled patients did not have their 6 month follow-up visit (or failed to attend their 6 month visit) prior to the termination of the study.||Participants|||Number
758437|NCT00617279|Secondary|Number of Patients With Secondary Patency at One Month|Secondary patency is defined as hemodynamic evidence of blood flow through an open graft that has previously undergone revision(s) to restore blood flow after occlusion.|One month|The number of patients analyzed at 1 month post-procedure does not equal the number of patients originally enrolled into the study. This is due to the fact that a number of enrolled patients did not have their 1 month follow-up visit (or failed to attend their 1 month visit) prior to the termination of the study.||Participants|||Number
758438|NCT00617279|Secondary|Number of Patients With Assisted Primary Patency at 12 Months Post-procedure|Assisted primary patency is defined as hemodynamic evidence of blood flow through an open graft that has previously undergone revision(s) within the graft to restore blood flow prior to occlusion.|12 months|The number of patients analyzed at 12 months post-procedure does not equal the number of patients originally enrolled into the study. This is due to the fact that a number of enrolled patients did not have their 12 month follow-up visit (or failed to attend their 12 month visit) prior to the termination of the study.||Participants|||Number
758494|NCT00617604|Secondary|Change From Month 1 in Creatinine Clearance|The creatinine clearance was calculated according to the Cockcroft-Gault formula.|Month 1, 3, and 6|"Full analysis set participants with available data at Month 1 (90, 84) and at Month 3 and Month 6 (indicated by n)."||mL/minute||Standard Deviation|Mean
758439|NCT00617279|Secondary|Number of Patients With Assisted Primary Patency at 6 Months Post-procedure|Assisted primary patency is defined as hemodynamic evidence of blood flow through an open graft that has previously undergone revision(s) within the graft to restore blood flow prior to occlusion.|6 months|The number of patients analyzed at 6 months post-procedure does not equal the number of patients originally enrolled into the study. This is due to the fact that a number of enrolled patients did not have their 6 month follow-up visit (or failed to attend their 6 month visit) prior to the termination of the study.||Participants|||Number
758440|NCT00617279|Secondary|Number of Patients With Assisted Primary Patency at One Month Post-procedure|Assisted primary patency is defined as hemodynamic evidence of blood flow through an open graft that has previously undergone revision(s) within the graft to restore blood flow prior to occlusion. The number of patients analyzed at 1 month post-procedure does not equal the number of patients originally enrolled into the study. This is due to the fact that a number of enrolled patients did not have their 1 month follow-up visit (or failed to attend their 1 month visit) prior to the termination of the study.|One month|||Participants|||Number
758441|NCT00617279|Secondary|Number of Patients With Primary Patency at 6 Months Post-procedure|Primary patency is defined as hemodynamic evidence of blood flow through an open graft that has maintained uninterrupted patency and has not previously undergone a revision to restore blood flow.|6 months|The number of patients analyzed at 6 months post-procedure does not equal the number of patients originally enrolled into the study. This is due to the fact that a number of enrolled patients did not have their 6 month follow-up visit (or failed to attend their 6 month visit) prior to the termination of the study.||Participants|||Number
758442|NCT00617279|Primary|Major Adverse Event Occurrences Through One Month Post-procedure|The number of Major Adverse Event occurrences through one month post-procedure. A major adverse event requires significant therapy, including unplanned increase in the level of care, permanent sequelae, hospitalization, or death. This outcome measure presents the number of Major Adverse Event occurrences (i.e. - one patient could have multiple occurrences), and differs from the Serious Adverse Events reporting measure, which presents the number of patients that have been affected by a Serious Adverse Event.|one month post-index procedure|||Events|||Number
758443|NCT00617279|Secondary|Number of Patients With Primary Patency at One Month Post-procedure|Primary patency is defined as hemodynamic evidence of blood flow through an open graft that has maintained uninterrupted patency and has not previously undergone a revision to restore blood flow.|One month|The number of patients analyzed at 1 month post-procedure does not equal the number of patients originally enrolled into the study. This is due to the fact that a number of enrolled patients did not have their 1 month follow-up visit (or failed to attend their 1 month visit) prior to the termination of the study.||Participants|||Number
758444|NCT00617279|Primary|Number of Patients With Primary Patency at 12 Months Post-procedure|Primary patency is defined as hemodynamic evidence of blood flow through an open graft that has maintained uninterrupted patency and has not previously undergone a revision to restore blood flow.|12 months|The number of patients analyzed at 12 months post-procedure does not equal the number of patients originally enrolled into the study. This is due to the fact that many enrolled patients did not have their 12 month follow-up visit prior to the termination of the study.||Participants|||Number
758445|NCT00617305|Secondary|Overall Survival, Evaluated at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and After Week 48|Overall survival was defined as the time from initiation of active treatment to death. Results are presented as the Kaplan-Meier estimate (% probability) of death after a given time.|Baseline to Week 48+|The Ambrisentan Only and Any Ambrisentan Groups were analyzed for Overall Survival||Probability of death occurring (%)||95% Confidence Interval|Number
758446|NCT00617305|Secondary|Time to Clinical Worsening of PAH, Evaluated at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and After Week 48|The time to clinical worsening was defined as the time from enrollment to the first occurrence of death, lung transplantation, hospitalization for PAH, atrial septostomy, or initiation of chronic parenteral prostanoid therapy. Results are presented as the Kaplan-Meier estimate (% probability) of having clinical worsening after a given time.|Baseline to Week 48+|The Ambrisentan Only and Any Ambrisentan Groups were analyzed for Time to Clinical Worsening||Probability of clinical worsening (%)||95% Confidence Interval|Number
758447|NCT00617305|Secondary|Change From Baseline in Log-transformed N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) Measured at Weeks 4, 12, 24, 36 and 48 (LOCF)|The primary analysis of this secondary outcome measure is mean percent change from Baseline to Week 24. The changes from Baseline to Weeks 4, 12, 36, and 48 were also evaluated. A decrease in log-transformed measurement value (pg/mL) indicates improvement for this patient population.|Baseline to Week 48|One patient (Any Placebo) was not evaluated for NT-proBNP. One patient (Placebo Only) had no baseline measurement, so no statistical analyses for change from baseline are given for the placebo only group (patient was only subject in this group).||pg/mL (log-transformed)||Standard Deviation|Mean
758448|NCT00617305|Secondary|Change From Baseline in World Health Organization (WHO) Functional Class (LOCF) Measured at Weeks 4, 12, 24, 36 and 48.|The primary analysis of this secondary outcome measure is change from Baseline to Week 24. The changes from Baseline to Weeks 4, 12, 36, and 48 were also evaluated. WHO categories are 1 to 4 with the worst category being 4. Improvement is represented by a change in category to a lower number (for example, change from category 3 to 2), and deterioration is represented by a change in category to a higher number (for example, change from category 2 to 4). No change is represented by no change in category (for example, category 2 which remains 2).|Baseline to Week 48|All enrolled Population||participants|||Number
758449|NCT00617305|Secondary|Change From Baseline in the Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) Quality of Life (QOL) Survey Overall Score Measured at Weeks 12, 24, 36 and 48 (LOCF)|The primary analysis of this secondary outcome measure is mean change from Baseline to Week 24. The changes from Baseline to Weeks 12, 36, and 48 were also evaluated. Lower scores and decreases from baseline represent improved functioning and QOL. The CAMPHOR survey was not assessed at Week 4. The total CAMPHOR score scale ranges from 0 (good) to 25 (poor). A reduction in score over time represents improvement in this patient population.|Baseline to Week 48|All enrolled Population||units on a scale||Standard Deviation|Mean
758495|NCT00617604|Secondary|Change From Month 1 in Glomerular Filtration Rate (GFR)|The GFR was calculated using the Modification of Diet in Renal Disease (MDRD) formula.|Month 1, 3, and 6|"Full analysis set participants with available data at Month 1 (98, 93 participants respectively) and at Month 3 and Month 6 (indicated by n)."||mL/min/1.73 m²||Standard Deviation|Mean
758450|NCT00617305|Secondary|Change in Dyspnea Index Measured at Weeks 4, 12, 24, 36 and 48 (LOCF)|The primary analysis of this secondary outcome measure is mean change from Baseline to Week 24. The changes from Baseline to Weeks 4, 12, 36, and 48 were also evaluated. The dyspnea index measures the degree of breathlessness after completion of the 6MWT using a scale of 0 to 10, with 0 indicating no breathlessness and 10 indicating maximum breathlessness.|Baseline to Week 48|All enrolled Population||units on a scale||Standard Deviation|Mean
758451|NCT00617305|Secondary|Change From Baseline in Six Minute Walk Distance (6MWD) Measured at Weeks 4, 12, 24, 36 and 48 (LOCF)|The primary analysis of this secondary outcome measure is mean change from Baseline to Week 24. The changes from Baseline to Weeks 4, 12, 36, and 48 were also evaluated. An increase in measurement value (meters walked) indicates improvement for this patient population.|Baseline to Week 48|All enrolled Population||meters walked||Standard Deviation|Mean
758452|NCT00617305|Secondary|Change From Baseline in Cardiac Output (LOCF)|This secondary hemodynamic outcome is supportive of the primary outcome. An increase in measurement value (L/min) indicates improvement for this patient population.|Baseline to Week 24|Patients with measurements at Baseline and Week 24 were evaluated||L/min||Standard Deviation|Mean
758453|NCT00617305|Secondary|Change From Baseline in Mean Right Atrial Pressure (mRAP) (LOCF)|This secondary hemodynamic outcome is supportive of the primary outcome. A decrease in measurement value (mmHg) indicates improvement for this patient population.|Baseline to Week 24|Patients with measurements at Baseline and Week 24 were evaluated||mmHg||Standard Deviation|Mean
758454|NCT00617305|Secondary|Change From Baseline in Mean Pulmonary Artery Pressure (mPAP) (LOCF)|This secondary hemodynamic outcome is supportive of the primary outcome. A decrease in measurement value (mmHg) indicates improvement for this patient population.|Baseline to Week 24|Patients with measurements at Baseline and Week 24 were evaluated||mmHg||Standard Deviation|Mean
758455|NCT00617305|Primary|Change From Baseline in Pulmonary Vascular Resistance (PVR), Last Observation Carried Forward (LOCF)|The primary objective of this study is to evaluate the change from baseline in PVR, and other hemodynamic parameters, following the addition of ambrisentan to background PDE-5i therapy in subjects with PAH who have demonstrated a sub-optimal response to PDE-5i monotherapy. A decrease in measurement value (dynes sec/cm^5) indicates improvement for this patient population.|Baseline to Week 24|Patients with measurements at Baseline and Week 24 were evaluated||dynes sec/cm^5||Standard Deviation|Mean
758456|NCT00617357|Secondary|Activities Assessment Scale (AAS)|The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from “No difficulty” to “Not able to do it.” The AAS has three subscales: sedentary activities (items 1–4); ambulatory activities (items 6–8); work/exercise activities (items 11–13). The AAS total and subscale scores are transformed to produce a range of 0–100, with higher values indicating greater functional activity.|24 Months|||units on a scale||Standard Deviation|Mean
758457|NCT00617357|Secondary|Activities Assessment Scale (AAS)|The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from “No difficulty” to “Not able to do it.” The AAS has three subscales: sedentary activities (items 1–4); ambulatory activities (items 6–8); work/exercise activities (items 11–13). The AAS total and subscale scores are transformed to produce a range of 0–100, with higher values indicating greater functional activity.|12 Months|||units on a scale||Standard Deviation|Mean
758458|NCT00617357|Secondary|Activities Assessment Scale (AAS)|The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from “No difficulty” to “Not able to do it.” The AAS has three subscales: sedentary activities (items 1–4); ambulatory activities (items 6–8); work/exercise activities (items 11–13). The AAS total and subscale scores are transformed to produce a range of 0–100, with higher values indicating greater functional activity.|6 Months|||units on a scale||Standard Deviation|Mean
758459|NCT00617357|Secondary|Activities Assessment Scale (AAS)|The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from “No difficulty” to “Not able to do it.” The AAS has three subscales: sedentary activities (items 1–4); ambulatory activities (items 6–8); work/exercise activities (items 11–13). The AAS total and subscale scores are transformed to produce a range of 0–100, with higher values indicating greater functional activity.|3 Months|||units on a scale||Standard Deviation|Mean
758460|NCT00617357|Secondary|Activities Assessment Scale (AAS)|The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from “No difficulty” to “Not able to do it.” The AAS has three subscales: sedentary activities (items 1–4); ambulatory activities (items 6–8); work/exercise activities (items 11–13). The AAS total and subscale scores are transformed to produce a range of 0–100, with higher values indicating greater functional activity.|30 Days|||units on a scale||Standard Deviation|Mean
758461|NCT00617357|Secondary|Activities Assessment Scale (AAS)|The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from “No difficulty” to “Not able to do it.” The AAS has three subscales: sedentary activities (items 1–4); ambulatory activities (items 6–8); work/exercise activities (items 11–13). The AAS total and subscale scores are numerically transformed to produce a range of 0–100, with higher values indicating greater functional activity.|Baseline|||units on a scale||Standard Deviation|Mean
758462|NCT00617357|Primary|Incidence of Wound Events|Wound Events are defined as those events which occurred in the area of the hernia repair and the repair site, including seroma, hematoma, dehiscence, infection, abscess, fistula, and re-herniation.|Postoperatively up to 24 months|80 patients were enrolled and received Strattice Reconstructive Tissue Matrix to support the repair and were included in the Intent to Treat (ITT) population.||participants|||Number
760304|NCT00634569|Secondary|Number of Infectious Episodes Per Year|Mean Number of infectious episodes per subject/year|12 months|||Infectious episodes||Standard Deviation|Mean
758463|NCT00617396|Primary|Adequate Relief in Pain Score During Treatment|"Biweekly relief in pain Biweekly subjects were asked whether they had adequate relief of pain. It was binary questionnaire i.e.-  Did you have adequate relief of pain in last two weeks? 1) yes 2) no The measure is percentage of subjects who said yes who had adequate relief of pain."|8 weeks|There was no exact statistical test used to determine the sample size. It is based on the capacity of site to recruit subjects.||percentage of subjects|||Number
758464|NCT00617409|Secondary|Overall Survival (OS)|To evaluate the survival of all patients enrolled on an intent-to-treat basis. Overall survival per treatment arm.|Up to 24 months|All participants.||months||95% Confidence Interval|Median
758465|NCT00617409|Primary|Tumor Response Rate (RR)|Overall Response: Complete Response (CR) + Partial Response (PR) + Stable Disease (SD). Efficacy of second line chemotherapy (single agent paclitaxel) after progression following the dendritic cell(DC)-based p53 vaccine (Ad.p53-DC vaccine), with (Arm C). To estimate the objective tumor response rate for each treatment group. Tumor response to be assessed via radiographic imaging after every 2 cycles of chemotherapy (paclitaxel). CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease (PD), taking as reference the smallest sum LD since the treatment started. PD: At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|12 months|All participants.||participants|||Number
758466|NCT00617461|Secondary|Mean Gabapentin Steady-State (ss) Average, Minimum and Maximum Concentrations|Steady-state average (Cave, ss), maximum (Cmax, ss), and minimum (Cmin,ss) plasma concentration of gabapentin in each participant were estimated using the gabapentin plasma concentration data and with the aid of a population pharmacokinetic model. Dispersion is represented by the fifth to ninety-fifth percentile, though labeled as “Full Range.” A total of 10 blood samples were collected per participant over the Baseline, Period 1, and Period 2 at various timepoints during the dosing interval. Plasma concentration of gabapentin in these samples was measured.|A total of 10 blood samples (2 samples at each visit) were collected per participant at Baseline, and the Week 1 and Week 4 visits for each period|Drug concentration data were available from 89 ITT Population participants. Data from 7 of these participants had one concentration with less than half of the first percentile of the concentrations observed at ss and were defined as non-compliant and were excluded from the pharmacokinetic (PK) analysis.||micrograms per milliliter||Full Range|Geometric Mean
758467|NCT00617461|Secondary|Change From Baseline in the Severity of Pain and the Impact of Pain as Assessed by the Brief Pain Inventory (BPI) at the Last Week of Each Treatment Period Using LOCF|The BPI assesses the severity and interference of pain; and consists of 6 items assessed on an 11-point NRS (0=no impact to 10=greatest impact). 2 summary scores are calculated: BPI Severity Score (average of first 4 items) and BPI Interference Score (average of 7 responses to item 6); where scores range from 0 to 10 (0=no impact to 10=greatest impact). Analysis of this endpoint is based on the change from baseline (BL) (EOMT score minus the BL score) using an ANCOVA model with BL value, BMI, grouped center as covariates. Data are summarized by dose, independent of treatment period.|Baseline and End of Treatment (Weeks 4 and 9, representing the last week of treatment)|ITT Population. There were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. There were many participants who did not respond to the questionnaire and could thus not be included in the analysis.||points on a scale||Standard Error|Least Squares Mean
758468|NCT00617461|Secondary|Change From Baseline in the Mean Sleep Interference Score at the Last Week of Each Treatment Period Using LOCF Data|Participants assessed sleep interference due to pain on a daily basis using the 11-point NRS (0=pain does not interfere with sleep, 10=pain completely interferes with sleep). Baseline and end of treatment scores are as defined for the primary endpoint. Change from baseline is calculated as the end of treatment score minus the baseline score. An ANCOVA with baseline value, BMI, grouped center as covariates was used. Data are summarized by dose, independent of treatment period.|Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)|Of the 93 participants in the ITT Population, there were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. In addition, 1 participant did not provide post-baseline data for sleep interference during the GEn 1200 mg treatment period, and was therefore not included in this analysis.||points on a scale||Standard Error|Least Squares Mean
758469|NCT00617461|Secondary|Number of Participants Who Are Responders on the Clinical Global Impression of Change (CGIC) Questionnaire at the Last Week of Each Treatment Period Presented by Period Using LOCF Data|"The CGIC is a single-item questionnaire designed to provide an overall assessment of treatment from the clinician's perspective since the start of the study. It is measured on a 7-point scale, where 1=very much improved and 7=very much worse. A participant is considered a responder if they have a response of very much improved or much improved. Data are summarized by dose within each treatment period."|End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)|ITT Population. There were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. There were many participants without a response data to this questionnaire and could thus not be included in the analysis.||participants|||Number
758470|NCT00617461|Secondary|Number of Participants Who Are Responders on the Clinical Global Impression of Change (CGIC) Questionnaire at the Last Week of Each Treatment Period Using LOCF Data|"The CGIC is a single-item questionnaire designed to provide an overall assessment of treatment from the clinician's perspective since the start of the study. It is measured on a 7-point scale, where 1=very much improved and 7=very much worse. A participant is considered a responder if they have a response of very much improved or much improved. Data are summarized by dose, independent of treatment period."|End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)|ITT Population. There were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. There were many participants without a response to this questionnaire and thus could not be included in the analysis.||participants|||Number
758496|NCT00617604|Secondary|Change From Month 1 in Serum Creatinine||Month 1, 3, and 6|"Full analysis set participants with available data at Month 1 (99 and 94 participants in each treatment group respectively) and at Month 3 and Month 6 (indicated by n)."||µmol/L||Standard Deviation|Mean
760305|NCT00634569|Secondary|Other Infections Documented by Fever and Physical Exam or Positive Radiograph.||12 months|||Number of other infections||Standard Deviation|Mean
758471|NCT00617461|Secondary|Number of Participants Who Are Responders on the Patient Global Impression of Change (PGIC) Questionnaire at the Last Week of Each Treatment Period Presented by Period Using LOCF Data|"The PGIC is a single-item questionnaire designed to provide an overall assessment of treatment from the participant's perspective since the start of the study. It is measured on a 7-point scale, where 1=very much improved and 7=very much worse. A participant is considered a responder if they have a response of very much improved or much improved. Data are summarized by dose within each treatment period."|End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)|ITT Population. There were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. There were many participants who did not respond to the questionnaire and thus could not be included in the analysis.||participants|||Number
758472|NCT00617461|Secondary|Number of Participants Who Are Responders on the Patient Global Impression of Change (PGIC) at the Last Week of Each Treatment Period Using LOCF Data|"The PGIC is a single-item questionnaire designed to provide an overall assessment of treatment from the participant's perspective since the start of the study. It is measured on a 7-point scale, where 1=very much improved and 7=very much worse. A participant is considered a responder if they have a response of very much improved or much improved Data are summarized by dose, independent of treatment period."|End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)|ITT Population. There were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. There were many participants who did not respond to the questionnaire and thus could not be included in the analysis.||participants|||Number
758473|NCT00617461|Secondary|Change From Baseline in the Mean Daily Dose in Milligrams of Rescue Medication at the Last Week of Each Treatment Period|Mean daily use of rescue medication (milligrams of acetaminophen) was calculated by determining the average number of tablets taken per day of rescue medication (Commercial Tylenol) during treatment and multiplying that by 500 mg. Baseline and end of treatment scores are as defined for the primary endpoint. Change from baseline is calculated as the end of treatment score minus the baseline score. An ANCOVA with baseline value, BMI, grouped center as covariates was used. Data are summarized by dose, independent of treatment period.|Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)|Of the 93 participants in the ITT Population, there were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. In addition, there was one participant who did not provide post-baseline data for rescue medication usage during the GEn 3600 mg treatment period, and was therefore not included in this analysis.||milligrams||Standard Error|Least Squares Mean
758474|NCT00617461|Secondary|Number of Participants Achieving Various Levels of Percent Reduction From Baseline in the Mean 24-hour Average Pain Intensity Score at the Last Week of Each Treatment Period Using LOCF Data by Period|Baseline and end of treatment scores are the calculated means of the 24-hour average pain scores for each participant during the last 7 days prior to randomization (Baseline) and the 7 days prior to the last on-treatment completed diary (end of treatment). Percent reduction from baseline was calculated as the [(end of treatment score minus the baseline score) divided by the baseline score], multiplied by 100. The PI-NRS is an 11-point scale (0=no pain, 10=pain as bad as you can imagine) by which a participant assesses their 24-hour average pain intensity. Data are summarized by period.|Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)|Of the 93 participants in the ITT Population, there were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. In addition, there was one participant who did not provide post-baseline data for 24-hour API while taking GEn 3600 mg in the first period, and was therefore not included in this analysis.||participants|||Number
758475|NCT00617461|Secondary|Number of Participants Achieving Various Levels of Percent Reduction From Baseline in the Mean 24-hour Average Pain Intensity Score at the Last Week of Each Treatment Period Using LOCF Data|Baseline and end of treatment (EOT) scores are the calculated means of the 24-hour average pain scores for each participant during the last 7 days prior to randomization (Baseline) and the 7 days prior to the last on-treatment completed diary (EOT). Percent reduction from baseline was calculated as the [(EOT score minus baseline score) divided by the baseline score], multiplied by 100. The PI-NRS is an 11-point scale (0=no pain, 10=pain as bad as you can imagine) by which a participant assesses their 24-hour average pain intensity. Data are summarized by dose, independent of treatment period.|Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)|Of the 93 participants in the ITT Population, there were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. In addition, there was one participant who did not provide post-baseline data for 24-hour API assessments during the GEn 3600 mg treatment period, and was therefore not included in this analysis.||participants|||Number
758476|NCT00617461|Secondary|Change From Baseline in the Mean Current Morning Pain Intensity Score at the Last Week of Each Treatment Period Using LOCF|"Current pain is defined as the participant's assessment of pain intensity right now. Participants recorded their current morning pain intensity in the morning upon wakening using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and end of treatment scores are as defined for the primary endpoint. Change from baseline is calculated as the end of treatment score minus the baseline score. An ANCOVA with baseline value, BMI, grouped center as covariates was used. Data are summarized by dose, independent of treatment period."|Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)|Of the 93 participants in the ITT Population, there were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. In addition, 1 participant did not provide post-baseline data for current morning pain during the GEn 1200 mg treatment period, and was therefore not included in this analysis.||points on a scale||Standard Error|Least Squares Mean
758497|NCT00617604|Secondary|Percentage of Participants With Anti-Lymphocyte Antibody Therapy for Treatment of Rejection at Month 6|The Kaplan-Meier estimate of anti-lymphocyte antibody therapy for acute rejection (clinically-treated or biopsy-confirmed) within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow-up visit.|6 months|Full analysis set||percentage of participants||90% Confidence Interval|Number
758546|NCT00617890|Secondary|Area Under the Concentration-time Curve (AUC) of Serum Levels of Robatumumab (Group 1 Only)||End of infusion on Day 1, and then prior to surgery, before and after the 2nd, 3rd, and 8th doses (up to 20 weeks)|Group 1, both dose levels: this outcome was not evaluated due to early termination of the study.|||||
758477|NCT00617461|Secondary|Change From Baseline in the Mean Night-time Worst Pain Intensity Score at the Last Week of Each Treatment Period Using LOCF|Night-time worst pain is defined as the participant's assessment of their worst pain intensity between going to bed and rising in the morning. Participants recorded night-time worst pain in the morning upon wakening using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and end of treatment scores are as defined for primary endpoint. Change from baseline = the end of treatment score minus the baseline score. An ANCOVA with baseline value, BMI, grouped center as covariates was used. Data are summarized by dose, independent of treatment period.|Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)|Of the 93 participants in the ITT Population, there were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. In addition, 1 participant did not provide post-baseline data for night-time pain assessments during the GEn 1200 mg treatment period, and was therefore not included in this analysis.||points on a scale||Standard Error|Least Squares Mean
758478|NCT00617461|Secondary|Change From Baseline in the Mean Night-time Average Pain Intensity (API) Score at the Last Week of Each Treatment Period Using LOCF|Night-time is defined as the time between going to bed in the evening and rising in the morning. Participants recorded night-time API on a daily basis in the morning upon wakening using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and end of treatment scores are as defined for the primary endpoint. Change from baseline is calculated as the end of treatment score minus the baseline score. An ANCOVA with baseline value, BMI, grouped center as covariates was used. Data are summarized by dose, independent of treatment period.|Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)|Of the 93 participants in the ITT Population, there were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. In addition, 1 participant did not provide post-baseline data for night-time pain assessments during the GEn 1200 mg treatment period, and was therefore not included in this analysis.||points on a scale||Standard Error|Least Squares Mean
758479|NCT00617461|Secondary|Change From Baseline in the Mean Current (Evening) Pain Intensity Score at the Last Week of Each Treatment Period Using LOCF Data|"Current pain is defined as the participant's assessment of pain intensity right now. Participants recorded their current evening pain intensity in the evening before bedtime using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and end of treatment scores are as defined for the primary endpoint. Change from baseline is calculated as the end of treatment score minus the baseline score. An ANCOVA with baseline value, BMI, grouped center as covariates was used. Data are summarized by dose, independent of treatment period."|Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)|Of the 93 participants in the ITT Population, there were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. In addition, 1 participant did not provide post-baseline data for current evening pain during the GEn 3600 mg treatment period, and was therefore not included in this analysis.||points on a scale||Standard Error|Least Squares Mean
758480|NCT00617461|Secondary|Change From Baseline in the Mean Day-time Worst Pain Intensity Score at the Last Week of Each Treatment Period Using LOCF Data|Day-time worst pain is defined as the participant's assessment of their worst pain intensity between rising in the morning and going to bed at night. Day-time worst pain was recorded in the evening before bedtime using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and end of treatment scores are as defined for the primary endpoint. Change from baseline is calculated as the end of treatment score minus the baseline score. An ANCOVA with baseline value, BMI, grouped center as covariates was used. Data are summarized by dose, independent of treatment period.|Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)|Of the 93 participants in the ITT Population, there were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. In addition, 1 participant did not provide post-baseline data for day-time pain assessments during the GEn 3600 mg treatment period, and was therefore not included in this analysis.||points on a scale||Standard Error|Least Squares Mean
758481|NCT00617461|Secondary|Change From Baseline in the Mean Day-time Average Pain Intensity (API) Score at the Last Week of Each Treatment Period Using LOCF Data|Day-time is defined as the time between rising in the morning and going to bed at night. Participants recorded day-time API on a daily basis in the evening before bedtime using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and end of treatment scores are as defined for the primary endpoint. Change from baseline is calculated as the end of treatment score minus the baseline score. An ANCOVA with baseline value, BMI, grouped center as covariates was used. Data are summarized by dose, independent of treatment period.|Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)|Of the 93 participants in the ITT Population, there were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. In addition, 1 participant did not provide post-baseline data for day-time pain assessments during the GEn 3600 mg treatment period, and was therefore not included in this analysis.||points on a scale||Standard Error|Least Squares Mean
758482|NCT00617461|Primary|Change From Baseline in the Mean 24-hour Average Pain Intensity (API) Score at the Last Week of Each Treatment Period Using LOCF Data for Each Treatment Period|Baseline and end of treatment values are the calculated means of the daily 24-hour API scores for each participant during the last 7 days prior to randomization (baseline) and the last 7 days on treatment within each period (end of treatment). Participants used a hand-held diary to rate their average pain intensity over the preceding 24 hours, using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). LOCF was used if less than 4 days of diary data were provided. The by period summary is provided as a sensitivity analysis for the primary analysis.|Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)|Of the 93 participants in the ITT Population, there were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. In addition, 1 participant did not provide post-baseline data for 24 hour API while taking GEn 3600 mg in the first period, and was therefore not included in this analysis.||points on a scale||Standard Deviation|Mean
758520|NCT00617708|Primary|Maximum Tolerated Dose Determination|Maximum dose of IMC-A12 (in combination with erlotinib and gemcitabine) at which 3/10 or fewer patients have dose-limiting toxicities (DLT). Toxicities graded according to the NCI Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE 3.0). DLT apply only during cycle 1 and should be drug-related (possible, probable, or definite).|28 days|Phase I patients receiving at least three doses of the assigned dose during Cycle 1 or whom developed a DLT.||mg/kg IMC-A12|||Number
758483|NCT00617461|Primary|Change From Baseline in the Mean 24-hour Average Pain Intensity (API) Score at the Last Week of Each Treatment Period Using Last Observation Carried Forward (LOCF) Data|Baseline and end of treatment values are the calculated means of the daily 24-hour API scores for each participant during the last 7 days prior to randomization (baseline) and the last 7 days on treatment within each period (end of treatment). Participants rated their API over the preceding 24 hours, using an 11-point PI-Numerical Rating Scale (0=no pain, 10=pain as bad as you can imagine). LOCF was used if less than 4 days of diary data were provided. Change from baseline was calculated as end of treatment minus baseline. Data are summarized by dose, independent of treatment period.|Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)|Of the 93 participants in the ITT Population, there were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. In addition, 1 participant did not provide post-baseline data for 24-hour API assessments during the GEn 3600mg treatment period, and was therefore not included in this analysis.||points on a scale||Standard Error|Least Squares Mean
758484|NCT00617591|Secondary|Occurrence of Induction Toxicities|"Tolerability of full dose Revlimid® with full dose Doxil® in combination with reduced schedule dexamethasone was to be assessed during Cycle 1 and at the start of Cycle 2 using, whenever possible, the National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE) v3.0.
Due to increased neutropenia and fatigue, toxicities were reviewed after the first 29 participants were enrolled."|24 Months|First 29 participants with the PLD starting dose of PLD 40 mg/m^2, due to increased neutropenia and fatigue.||percentage of participants|||Number
758485|NCT00617591|Secondary|2 Year Overall Survival (OS) Rate|Percentage of participants with Overall Survival in response to Dd-R in newly diagnosed multiple myeloma patients with active disease. Overall survival is time from study entry to death of any cause.|24 Months|All participants||percentage of participants|||Number
758486|NCT00617591|Secondary|Median Progression Free Survival (PFS) in Months|PFS: Time from study entry to progression/relapse or death from study entry to death of any cause, assessed using International Myeloma Working Group Response Definitions. Progressive Disease (PD): One of the following criteria must be met: a. Increase of 25% or greater in serum M protein (absolute increase greater or equal to 0.5g/dl); b. Increase of 25% or greater in urine M protein (absolute increase greater than 200 mg/24h); c. Increase of 25% or greater in the difference between the involved and uninvolved free light chain (absolute increase greater than 10 mg/dl); d. Increase of 25% or greater in bone marrow plasma cell percentage (absolute percent greater than 5% in case the patient was in CR and 10% otherwise); i.e. Definite development of new bone lesions or soft tissue plasmacytomas, or increase in the size of existing plasmacytomas by greater or equal to 25%. Development of hypercalcemia (serum calcium > 11.5 mg/dl) attributable only to the plasma cell dyscrasia.|24 Months|All participants||months||95% Confidence Interval|Median
758487|NCT00617591|Primary|Percentage of Participants With Very Good Partial Remission (VGPR) or Better|Quality of response: % Complete Response (CR) + Very Good Partial Remission (VGPR) to induction Dd-R as assessed using International Myeloma Working Group Response Definitions. Very Good Partial Remission (VGPR): Detectable serum and urine M component on immunofixation but not on electrophoresis or 90% or greater reduction in serum M protein with less than 100 mg/24 h of urinary M protein. Complete Remission (CR): The presence of less than 5% bone marrow plasmacytosis and the disappearance of all evidence of serum and urine M-components on electrophoresis as well as by immunofixation. In addition, soft tissue plasmacytoma must have disappeared.|24 Months|All participants||percentage of participants|||Number
758488|NCT00617591|Primary|Overall Response Rate (ORR) - Percentage of Participants With Partial Response or Better With Induction Regimen|ORR assessed using International Myeloma Working Group Response Definitions. Partial Remission (PR): A greater than 50% reduction in the serum paraprotein, and if present, a greater than 90% reduction in the urine M protein excretion. Patients must also have a decrease by 50% in the size of soft tissue plasmacytoma. If serum and urine M protein are not measurable, a 50% or greater decreased in the difference of the involved and uninvolved free light chain. Very Good Partial Remission (VGPR): Detectable serum and urine M component on immunofixation but not on electrophoresis or 90% or greater reduction in serum M protein with less than 100 mg/24 h of urinary M protein. Complete Remission (CR): The presence of less than 5% bone marrow plasmacytosis and the disappearance of all evidence of serum and urine M-components on electrophoresis as well as by immunofixation. In addition, soft tissue plasmacytoma must have disappeared.|24 Months|All participants||percentage of participants|||Number
758489|NCT00617604|Secondary|Number of Participants With Adverse Events|"Causally related was defined as adverse events (AEs) assessed by the Investigator as possibly or probably related to study drug or records where the relationship was missing.
A serious adverse event (SAE) was any untoward medical occurrence that, at any dose:
Resulted in death.
Was life-threatening.
Resulted in persistent or significant disability/incapacity.
Resulted in congenital anomaly or birth defect.
Required patient hospitalization or led to prolongation of hospitalization
Was considered a medically important event.
All rejections and any BK virus, Epstein Barr virus and/or cytomegalovirus infection had to be reported as an SAE"|6 Months|Safety analysis set (all randomized participants who received at least one dose of study drug).||participants|||Number
758490|NCT00617604|Secondary|Percentage of Participants With Treatment Failure at Month 6|Treatment failure is defined as efficacy failure (death, graft loss, biopsy-confirmed acute T-cell mediated rejection assessed by local reading, lost to follow-up) or early discontinuation of alefacept/placebo at any time (during the 12-week administration period) for any reason. The Kaplan-Meier estimate of treatment failure within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow-up visit.|6 months|Full analysis set||percentage of participants||90% Confidence Interval|Number
758491|NCT00617604|Secondary|Percentage of Participants With Delayed Graft Function|Delayed graft function was defined as the requirement for dialysis within the first week post-transplant.|1 week|Full analysis set||percentage of participants|||Number
758492|NCT00617604|Secondary|Percentage of Participants With Efficacy Failure at Month 6|"Efficacy failure is defined as death, graft loss, biopsy-confirmed acute T-cell mediated rejection assessed by local reading or lost to follow-up.
The Kaplan-Meier estimate of efficacy failure within the first 6 months following transplantation is reported."|6 months|Full analysis set||percentage of participants||90% Confidence Interval|Number
758493|NCT00617604|Secondary|GFR Measured by Iothalamate Clearance at Month 6|GFR measured using the iothalamate clearance method and determined by a central laboratory.|Month 6|Full analysis set participants with available data||mL/minute||Standard Deviation|Mean
758498|NCT00617604|Secondary|Maximum Histological Grade of All Biopsies After Local Review|"The grade of acute rejection was classified according to Banff 97/05 updated version. If a patient had more than 1 rejection episode, the episode with the most severe grade was used.
Acute T-cell mediated rejection:
Grade IA: significant interstitial infiltration (>25% parenchyma affected) and foci of moderate tubulitis;
Grade IB: significant interstitial infiltration (>25% parenchyma affected) and foci of severe tubulitis;
Grade IIA: mild to moderate intimal arteritis;
Grade IIB: severe intimal arteritis comprising >25% of the luminal area;
Grade III: “transmural” arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocyte inflammation.
Acute antibody-mediated rejection:
Grade I: acute tubular necrosis-like – complement split product positive (C4d+), minimal inflammation;
Grade II: capillary-margination and/or thromboses, C4d+
Grade III: arterial – v3, C4d+."|6 months|Full analysis set||percentage of participants|||Number
758499|NCT00617604|Secondary|Graft Survival|"Graft survival was defined as any participant who was known to have a functioning graft (i.e., not graft loss) at 6 months. Graft loss is defined as re-transplantation, nephrectomy, death or as dialysis ongoing at end of study or at discontinuation of the participant unless superseded by follow-up information.
The Kaplan-Meier estimate of graft survival within the first 6 months following transplantation is reported. Participants lost to follow-up were censored at the time of last assessment."|6 months|Full analysis set||percentage of participants||90% Confidence Interval|Number
758500|NCT00617604|Secondary|Patient Survival|Patient survival is any participant known to be alive at Month 6. The Kaplan-Meier estimate of patient survival within the first 6 months following transplantation is reported. Participants lost to follow-up were censored at the time of last assessment.|6 months|Full analysis set||percentage of participants||90% Confidence Interval|Number
758501|NCT00617604|Secondary|Percentage of Participants With Biopsy-Confirmed Acute T-cell Mediated Rejection as Assessed by Central Review at Month 6|"Biopsies were graded by the central reviewer according to the Banff 97/05 updated histological classification. A biopsy confirmed acute rejection was an event of suspected acute rejection confirmed by a graft biopsy result of Banff grade ≥ 1.
The Kaplan-Meier estimate of biopsy-confirmed acute T-cell mediated rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit."|6 months|Full analysis set||percentage of participants||90% Confidence Interval|Number
758502|NCT00617604|Secondary|Percentage of Participants With Steroid-resistant Acute Rejection at Month 6|"A steroid-resistant acute rejection is defined as a rejection episode which did not resolve following treatment with corticosteroids. In the case that a rejection episode was not treated with corticosteroids first but only with antibodies, it was included in this category.
The Kaplan-Meier estimate of steroid-resistant acute rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit."|6 months|Full analysis set||percentage of participants||90% Confidence Interval|Number
758503|NCT00617604|Secondary|Percentage of Participants With Clinically Treated Acute Rejection at Month 6|Patients who received immunosuppressive medications for the treatment of suspected or biopsy-confirmed acute rejections were considered to have a clinically-treated acute rejection. The Kaplan-Meier estimate of clinically treated acute rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow-up visit.|6 months|Full analysis set||percentage of participants||90% Confidence Interval|Number
758504|NCT00617604|Secondary|Percentage of Participants With Acute Rejection Diagnosed by Signs and Symptoms at Month 6|Acute rejection diagnosed by signs and symptoms, including biopsy-confirmed or suspected (not confirmed by biopsy - i.e. no biopsy was performed or biopsy did not confirm an acute T-cell mediated rejection). The Kaplan-Meier estimate of acute rejection diagnosed by signs and symptoms within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit.|6 months|Full analysis set||percentage of participants||90% Confidence Interval|Number
758505|NCT00617604|Secondary|Percentage of Participants With Biopsy Confirmed Acute Mixed T-Cell Mediated and Antibody-Mediated Rejection at Month 6|"Biopsies were graded by the clinical site pathologist.according to the Banff 97/05 updated histological classification. A biopsy confirmed acute rejection was an event of suspected acute rejection confirmed by a graft biopsy result of Banff grade ≥ 1.
The Kaplan-Meier estimate of biopsy-confirmed acute mixed T-cell mediated and antibody-mediated rejections within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit."|6 months|Full analysis set||percentage of participants||90% Confidence Interval|Number
758506|NCT00617604|Secondary|Percentage of Participants With Biopsy Confirmed Acute Rejection (T-Cell Mediated or Antibody Mediated) at Month 6|"Biopsies were graded by the clinical site pathologist.according to the Banff 97/05 updated histological classification. A biopsy confirmed acute rejection was an event of suspected acute rejection confirmed by a graft biopsy result of Banff grade ≥ 1.
The Kaplan-Meier estimate of biopsy-confirmed acute T-cell mediated or antibody-mediated rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit."|6 months|Full analysis set||percentage of participants||90% Confidence Interval|Number
758507|NCT00617604|Secondary|Percentage of Participants With Biopsy Confirmed Antibody-Mediated Acute Rejection at Month 6|"Biopsies were graded by the clinical site pathologist.according to the Banff 97/05 updated histological classification:
Acute antibody-mediated rejection - documented anti-donor antibody (‘suspicious for’ if antibody not demonstrated):
Grade I: acute tubular necrosis-like - complement split product positive (C4d+), minimal inflammation;
Grade II: capillary-margination and/or thromboses, C4d+
Grade III: arterial - v3, C4d+.
A biopsy confirmed acute rejection was an event of suspected acute rejection confirmed by a graft biopsy result of Banff grade ≥ 1.
The Kaplan-Meier estimate of biopsy-confirmed antibody-mediated acute rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit."|6 months|Full analysis set||percentage of participants||90% Confidence Interval|Number
758521|NCT00617708|Secondary|Overall Survival|From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Up to 3 years|Eligible patients in the Phase II portion of the study.||months||95% Confidence Interval|Median
758508|NCT00617604|Primary|Percentage of Participants With Biopsy-confirmed Acute T-cell Mediated Rejection at Month 6 Assessed by Local Review|"Biopsies were graded by the clinical site pathologist.according to the Banff 97/05 updated histological classification:
Grade IA: significant interstitial infiltration (>25% parenchyma affected) and foci of moderate tubulitis;
Grade IB: significant interstitial infiltration (>25% parenchyma affected) and foci of severe tubulitis;
Grade IIA: mild to moderate intimal arteritis;
Grade IIB: severe intimal arteritis comprising >25% of the luminal area;
Grade III: transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocyte inflammation.
A biopsy confirmed acute rejection was an event of suspected acute rejection confirmed by a graft biopsy result of Banff grade ≥ 1.
The Kaplan-Meier estimate of biopsy-confirmed acute T-cell mediated rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit."|6 months|Full analysis set (all randomized and transplanted participants who received at least 1 dose of study drug)||percentage of participants||90% Confidence Interval|Number
758509|NCT00617669|Secondary|PSA Response|PSA response defined as >50% decrease in serum PSA values from baseline seen in at least 2 consecutive PSA values at least 2 weeks apart.|While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)|Full Analysis Set||Participants|||Number
758510|NCT00617669|Secondary|Health Related Quality of Life|Median time (in months) from randomisation until deterioration of Health Related Quality of Life using the Kaplan-Meier method, where deterioration is defined as a change from baseline of less than or equal to -6 points in Total FACT-P score maintained for 2 consecutive visits.|While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)|Full Analysis Set||Months||Inter-Quartile Range|Median
758511|NCT00617669|Secondary|Pain Response|Number of patients with a pain response, defined as a decrease in brief pain inventory questionnaire (BPI) of at least 2 points from baseline or a decrease in opiate use of 25% from baseline.|While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)|The Pain Response Analysis Set includes patients who were either receiving opiates at baseline (randomisation) or with a baseline BPI score ≥2.||Participants|||Number
758512|NCT00617669|Secondary|Time to Pain Progression|Median time (in months) from randomisation until date of first assessment of increased pain using the Kaplan-Meier method, where increased pain event is defined as the first of a patient requiring opiate medication for duration of ≥1 week for pain due to prostate cancer metastasis, pain due to metastasis that has an increase in the worst pain item of the Brief Pain Inventory (BPI) from baseline to a minimum score of 5 with no decrease in analgesic use, or pain due to metastasis requiring radionuclide therapy, radiation therapy or surgery.|While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)|Full Analysis Set||Months||Inter-Quartile Range|Median
758513|NCT00617669|Secondary|Time to Prostate-specific Antigen (PSA) Progression|Median time (in months) from randomisation until first PSA value >50% higher than baseline of at least 5ng/ml seen in at least 2 consecutive PSA values at least 2 weeks apart using the Kaplan-Meier method.|While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)|||Months||Inter-Quartile Range|Median
758514|NCT00617669|Secondary|Incidence of Skeletal Related Events|Median time (in months) from randomisation until occurrence of a skeletal related event using the Kaplan-Meier method, where skeletal related event is defined as the first occurrence of a pathological fracture, a vertebral compression fracture not related to trauma, prophylactic surgery or radiation for impending fracture or spinal cord compression, or a spinal cord compression.|While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)|Full Analysis Set||Months||Inter-Quartile Range|Median
758515|NCT00617669|Secondary|Progression Free Survival|Median time (in months) from randomisation until clinical progression of disease using the Kaplan-Meier method. Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline|Patients were followed for progression up to 40 months|Full Analysis Set||Months||Inter-Quartile Range|Median
758516|NCT00617669|Primary|Overall Survival|Median time (in months) from randomisation until death using the Kaplan-Meier method.|Patients were followed for survival up to 40 months|Full Analysis Set||Months||Inter-Quartile Range|Median
758517|NCT00617708|Primary|Progression-Free Survival|From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact.|Up to 3 years|Eligible patients in the Phase II portion of the study.||months||95% Confidence Interval|Median
758518|NCT00617708|Secondary|Toxicity|Number of patients with Grade 3 through 5 adverse events that are related to study drug. Only adverse events that are possibly, probably or definitely related to study drug are reported.|Up to 3 years|Eligible patients who received any treatment and were assessed for toxicity were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.||Participants|||Number
758519|NCT00617708|Secondary|Response|Confirmed response (CR) is two or more objective statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration. Partial response (PR) is two or more objective statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration. Unconfirmed CR is one objective status of CR documented before progression or symptomatic deterioration but not qualifying as CR or PR. Unconfirmed PR is one objective status of PR documented before progression or symptomatic deterioration but not qualifying as CR, PR or unconfirmed CR.|Up to 3 years|Eligible patients in the Phase II portion of the study with measurable disease and adequate response assessment.||percentage of participants||95% Confidence Interval|Number
758547|NCT00617890|Secondary|Time Until Tumor Relapse (Group 1 Only)|This is a measure of the time from the start of the study to documented relapse of disease.|From start of treatment until relapse or data analysis cut off (Up to 3.4 years)|Group 1 participants; this outcome was not evaluated due to early termination of the study.|||||
758522|NCT00617773|Post-Hoc|Progression Free Survival in Patients Without Ascites and no Visceral Disease at Baseline Versus Patients With Ascites and/or Visceral Disease at Baseline|Progression free survival (PFS) is defined as the duration of time from start of treatment to time of disease progression.|From the first day of the investigational product administration until documentation of disease progression or death due to any cause (whichever occurred first) while the patient was on treatment, non-treatment period, or during the long-term follow-up.|All patients enrolled in the study that received at least 4 doses of investigational product and that were assessed for visceral disease and ascites at baseline were considered for this analysis.||weeks||95% Confidence Interval|Median
758523|NCT00617773|Post-Hoc|Progression Free Survival in Patients With and Without Visceral Disease at Baseline|Progression free survival (PFS) is defined as the duration of time from start of treatment to time of disease progression|From the first day of the investigational product administration until documentation of disease progression or death due to any cause (whichever occurred first) while the patient was on treatment, non-treatment period, or during the long-term follow-up.|All patients enrolled in the study that received at least 4 doses of investigational product and that were assessed for visceral disease at baseline were considered for this analysis.||weeks||95% Confidence Interval|Median
758524|NCT00617773|Post-Hoc|Progression Free Survival in Patients With and Without Ascites at Baseline|Progression free survival (PFS) is defined as the duration of time from start of treatment to time of disease progression.|From the first day of the investigational product administration until documentation of disease progression or death due to any cause (whichever occurred first) while the patient was on treatment, non-treatment period, or during the long-term follow-up.|All patients enrolled in the study that received at least 4 doses of investigational product were considered to this analysis.||weeks||95% Confidence Interval|Median
758525|NCT00617773|Other Pre-specified|12-Month Survival Rate|Rate of patients alive 12 months after starting therapy with the investigational product.|12 months from the start of study treatment.|All patients enrolled in the study that received at least 4 doses of investigational product were considered to this analysis.||percentage of participants||95% Confidence Interval|Number
758526|NCT00617773|Other Pre-specified|Overall Survival|Measured from the beginning of therapy until the date of death or for patients without a known date of death, they will be censored at the date they were last known to be alive.|From start of study treatment until death or the date that patients were last known to be alive. An average of 56.126 weeks.|All patients enrolled in the study that received at least 4 doses of investigational product were considered to this analysis.||weeks||Full Range|Median
758527|NCT00617773|Other Pre-specified|Progression Free Survival (PFS)|Progression free survival (PFS) is defined as the duration of time from start of treatment to time of disease progression.|From the first day of the investigational product administration until documentation of disease progression or death due to any cause (whichever occurred first). An average of 16.5549 weeks.|All patients enrolled in the study that received at least 4 doses of investigational product and that were evaluable for response were considered to this analysis.||weeks||Full Range|Median
758528|NCT00617773|Other Pre-specified|Clinical Benefit|"The clinical benefit was calculated considering all patients with objective response rate (CR + PR) or stable disease (SD) for at least 24 weeks according RECIST or CA-125 if patients were non-assessable or when assessment by RECIST was unknown.
Clinical benefit = 100% x (Number of patients with objective response + Number of patients with stable disease for at least 24 weeks) / Number of patients included in the efficacy population.
The evaluation of target and non-target lesions is described at the Outcome Measure titled Best Overall Response. CR: Complete Response; PR: Partial Response; SD: Stable Disease."|From start of study treatment until the end of Cycle 3 (24 weeks).|All patients enrolled in the study that received at least 4 doses of investigational product and that were evaluable for response were considered to this analysis.||percentage of participants||95% Confidence Interval|Number
758529|NCT00617773|Secondary|Mean Cmax and Cmin of Hu3S193 Relating to the First 8 Doses|Cmax = Peak (post-dosing) IP plasma concentration. Cmin = Trough (pre-dosing) IP plasma concentration (Cmin). Plasma concentration of Hu3S193 expressed in µg/mL.|Pre-dose (within 10 minutes) and Post-dose (5 minutes after completion of infusion) on weeks 1, 2, 3, 4, 5, 6, 7 and 8 of Cycle 1.|All patients enrolled in the study that received at least 8 doses of investigational product were considered to this analysis.||µg/mL||Standard Deviation|Mean
758530|NCT00617773|Secondary|Mean Cmax and Cmin of Hu3S193 Relating to the First 4 Doses.|Cmax = Peak (post-dosing) IP (Investigational Product) plasma concentration. Cmin = Trough (pre-dosing) IP plasma concentration (Cmin). Plasma concentration of Hu3S193 expressed in µg/mL.|Pre-dose (within 10 minutes) and Post-dose (5 minutes after completion of infusion) on weeks 1, 2, 3, and 4 of Cycle 1.|All patients enrolled in the study that received at least 4 doses of investigational product were considered to this analysis.||µg/mL||Standard Deviation|Mean
758531|NCT00617773|Secondary|Number of Participants With Adverse Events Reasonably Related to the Investigational Product (Incidence Greater Than 5%).|Adverse events with possible, probable or definite relationship to the investigational product were considered to be reasonably related.|From the first dose of investigational product up to 30 days after the last dose of investigational product|||participants|||Number
758532|NCT00617773|Secondary|Number of Participants With Adverse Events and Serious Adverse Events|A listing of all adverse events is located in the Reported Adverse Event module.|From the first dose of investigational product up to 30 days after the last dose of investigational product|All patients enrolled in the study that received at least 1 dose of investigational product were considered for safety evaluation.||participants|||Number
758544|NCT00617890|Secondary|Number of Participants Experiencing Treatment-Emergent Adverse Events|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment. Treatment-emergent adverse events are those that occur after participants have received study treatment, or existing adverse events that occurred during screening that increase in severity after study treatment. Adverse events in the Group 1: 0.3 mg/kg arm that occurred after switching to the 10 mg/kg dose are displayed under the originally assigned treatment.|Up to 2 years|All participants receiving study drug.||Participants|||Number
758545|NCT00617890|Secondary|Incidence of Anti-robatumumab Antibodies|For biological agents, it is possible for the host (participant) to develop antibodies to the agent. This outcome measure was planned to find out the number of participants who developed the antibodies after treatment with robatumumab.|Up to 2 years|This outcome was not evaluated due to early termination of the study.|||||
758533|NCT00617773|Primary|Best Overall Response|"Best response recorded from the start of treatment until disease progression/recurrence. Includes all patients evaluable for efficacy, regardless of used criteria: RECIST or CA-125 (Cancer Antigen 125).
Evaluation of target lesions: Complete Response (CR), resolution of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter (LD sum) of target lesions, taking as reference the baseline LD sum; Progressive Disease (PD), a 20% increase in LD sum of target lesions or the appearance of new lesion(s); Stable Disease (SD), no sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD. Evaluation of non-target lesions: CR, resolution of all non-target lesions and normalization of CA-125 level; SD, persistence of one or more non-target lesions and/or maintenance of CA-125 level above the normal limits; PD, appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions."|From start of study treatment until the end of Cycle 1 (8 weeks), Cycle 2 (16 weeks) or Cycle 3 (24 weeks).|All patients enrolled in the study that received at least 4 doses of investigational product were considered to the efficacy evaluation.||participants|||Number
758534|NCT00617851|Secondary|Percentage of Subjects With Seroprotection and Seroconversion (Strain B)|"The percentage of subjects who were seroprotected and seroconverted were considered statistically compliant with the stated CBER guidance criteria if:
the lower bound of the two-sided 95% CI for the percentage of seroprotected subjects (HI antibody titer ≥1:40) met or exceeded 70%.
the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion rate (prevaccination HI<10/ postvaccination HI ≥40 or at least a fourfold increase in titer from non-negative prevaccination serum [HI≥10]), for HI antibody met or exceeded 40%."|21 days after vaccination|"The analysis was performed on the per-protocol population, defined as all subjects enrolled who:
received all the relevant doses of vaccine correctly, and
provided evaluable serum samples at the relevant time points, and
had no major protocol deviation"||percentages of participants||95% Confidence Interval|Mean
758535|NCT00617851|Secondary|Percentage of Subjects With Seroprotection and Seroconversion (Strain A/H3N2)|"The percentage of subjects who were seroprotected and seroconverted were considered statistically compliant with the stated CBER guidance criteria if:
the lower bound of the two-sided 95% CI for the percentage of seroprotected subjects (HI antibody titer ≥1:40) met or exceeded 70%.
the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion rate (prevaccination HI<10/ postvaccination HI ≥40 or at least a fourfold increase in titer from non-negative prevaccination serum [HI≥10]), for HI antibody met or exceeded 40%."|21 days after vaccination|"The analysis was performed on the per-protocol population, defined as all subjects enrolled who:
received all the relevant doses of vaccine correctly, and
provided evaluable serum samples at the relevant time points, and
had no major protocol deviation"||percentages of participants||95% Confidence Interval|Mean
758536|NCT00617851|Secondary|Percentage of Subjects With Seroprotection and Seroconversion (Strain A/H1N1)|"The percentage of subjects who were seroprotected and seroconverted were considered statistically compliant with the stated CBER guidance criteria if:
the lower bound of the two-sided 95% CI for the percentage of seroprotected subjects (HI antibody titer ≥1:40) met or exceeded 70%.
the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion rate (prevaccination HI<10/ postvaccination HI ≥40 or at least a fourfold increase in titer from non-negative prevaccination serum [HI≥10]), for HI antibody met or exceeded 40%."|21 days after vaccination|"The analysis was performed on the per-protocol population, defined as all subjects enrolled who:
received all the relevant doses of vaccine correctly, and
provided evaluable serum samples at the relevant time points, and
had no major protocol deviation"||percentages of participants||95% Confidence Interval|Mean
758537|NCT00617851|Secondary|Number of Subjects With at Least One Unsolicited Adverse Event|Number of subjects reporting at least one unsolicited adverse event, regardless of the assessement of relatedness to the study vaccines (each of the three consecutive production lots of the investigational influenza virus vaccine, the pooled influenza virus vaccine, and the comparator influenza vaccine).|3 weeks after vaccination|The analysis was performed on the safety population, defined as all subjects who provided post-baseline safety data.||participants|||Number
758538|NCT00617851|Secondary|Number of Subjects Reporting Solicited Local and Systemic Symptoms|Solicited local and systemic reactions were assessed after vaccination for the two vaccines (three consecutive production lots pooled for the investigational influenza virus vaccine and comparator) and for each of the three consecutive production lots of the investigational influenza virus vaccine.|7 days after vaccination|The analysis was performed on the safety population, defined as all subjects who provided post-baseline safety data.||Participants|||Number
758539|NCT00617851|Secondary|Geometric Mean Titers (GMTs), by Vaccine Group and Strain|The GMTs and 95% CIs were calculated for each of the vaccine group (three consecutive production lots pooled for the investigational influenza virus vaccine and comparator) and for each strain.|21 days after vaccination|"The analysis was performed on the per-protocol population, defined as all subjects enrolled who:
received all the relevant doses of vaccine correctly, and
provided evaluable serum samples at the relevant time points, and
had no major protocol deviation"||titers||95% Confidence Interval|Geometric Mean
758540|NCT00617851|Primary|Geometric Mean Titers (GMTs), by Vaccine Lots|The immunologic equivalence of three consecutive production lots of the influenza virus vaccine was measured in terms of GMTs for all vaccine influenza strains.|21 days after vaccination|"The analysis was performed on the per-protocol population, defined as all subjects enrolled who:
received all the relevant doses of vaccine correctly, and
provided evaluable serum samples at the relevant time points, and
had no major protocol deviation"||Titers||95% Confidence Interval|Geometric Mean
758541|NCT00617890|Secondary|Duration of Response (Groups 2 and 3 Only)|This is a measure of the amount of time in which the tumor responded to therapy.|From time of documented response until disease progression or data analysis cut off (Up to 3.4 years)|Group 2 and 3 participants; this outcome was not evaluated due to early termination of the study|||||
758542|NCT00617890|Secondary|Overall Survival (Groups 2 and 3 Only)|This is a measure of the time of survival from first dose to documentation of death|From start of treatment until death or data analysis cut off (Up to 3.4 years)|Group 2 and 3 Participants||Months||95% Confidence Interval|Median
758543|NCT00617890|Secondary|Time to Disease Progression (Groups 2 and 3 Only)|This is a measure of the time from the start of the study to the time of documented disease progression.|From the start of treatment until disease progression or data analysis cut off (Up to 3.4 years)|All participants in Groups 2 and 3; this outcome was not evaluated due to early termination of the study|||||
758549|NCT00617890|Primary|Number of Participants Achieving a Complete Response, a Partial Response, or Stable Disease (Group 2 Only)|Responses to treatment (complete response, partial response, or stable disease) confirmed by central review for Participants in Group 2. Response was based on Response Evaluation Criteria in Solid Tumors (RECIST) and World Health Organization (WHO) criteria.|Up to 1 year following the start of study therapy|Group 2 participants with evaluable data.||Participants|||Number
758550|NCT00617890|Primary|Number of Participants With >= 25% Change in Tumor Proliferation After Exposure to Robatumumab (Group 1 Only)|Tumor proliferation was measured using Ki-67 levels. Ki-67 is nuclear protein associated with cellular proliferation.|Approximately 14 days|Group 1 Participants; this outcome was not evaluated due to early termination of the study.|||||
758551|NCT00617890|Primary|Number of Participants Achieving a Complete Response or Partial Response (Group 3 Only)|This is a measure of the number of participants with a complete response (CR) or partial response (PR) to therapy, confirmed by central review. Response was based on Response Evaluation Criteria in Solid Tumors (RECIST) and World Health Organization (WHO) criteria.|Up to 1 year following the start of study therapy|Participants in Group 3 with evaluable data.||Participants|||Number
758552|NCT00617903|Secondary|Percentage of Participants With IGA Based Patient Response at Weeks 4, 8, 12 and End of Study (LOCF)||At Weeks 4, 8, 12 and End of Study (LOCF)|||Percentage of participants|||Number
758553|NCT00617903|Secondary|Percentage of Participants With IGA Based Therapeutic Success at Weeks 4, 8 and 12||At Weeks 4, 8 and 12|||Percentage of participants|||Number
758554|NCT00617903|Secondary|Patients’ Opinion on Cosmetic Acceptability at End of Study|Patient’s opinion on cosmetic acceptability: 1 - very good; 2 – good; 3 – satisfactory; 4 – poor; 5 - no opinion|At End of Study (Week 12)|All subjects of the FAS population for which this measurement was evaluated (one-time evaluation at the last study visit; FAS observed cases||Percentage of participants|||Number
758555|NCT00617903|Secondary|Patients’ Rating of Overall Improvement at End of Study|Patient’s rating of overall improvement: 1 – excellent; 2 – good; 3 – fair; 4 - no improvement; 5 – worse|At End of Study (Week 12)|All subjects of the FAS population for which this measurement was evaluated (one-time evaluation at the last study visit; FAS observed cases||Percentage of participants|||Number
758556|NCT00617903|Secondary|Investigator’s Rating of Overall Improvement at End of Study|Investigator’s rating of overall improvement: 1 - excellent improvement; 2 - marked improvement; 3 - moderate improvement; 4 - no change; 5 – deterioration|At End of Study (Week 12)|All subjects of the FAS population for which this measurement was evaluated (one-time evaluation at the last study visit; FAS observed cases)||Percentage of participants|||Number
758557|NCT00617903|Secondary|Grouped Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)|Telangiectasia intensity score: 1 – None; 2 – Mild; 3 – Moderate; 4 - Severe|Baseline and Weeks 4, 8, 12 and End of Study (LOCF)|||Percentage of participants|||Number
758558|NCT00617903|Secondary|Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)|Telangiectasia intensity score: 1 – None; 2 – Mild; 3 – Moderate; 4 - Severe|Baseline and Weeks 4, 8, 12 and End of Study (LOCF)|||Scores on a scale||Standard Deviation|Mean
758559|NCT00617903|Secondary|Percentage of Participants With Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)|Telangiectasia intensity score: 1 – None; 2 – Mild; 3 – Moderate; 4 - Severe|At Weeks 4, 8, 12 and End of Study (LOCF)|||Percentage of participants|||Number
758560|NCT00617903|Secondary|Grouped Change From Baseline in Erythema Intensity Score at Weeks 4, 8 and 12|Erythema intensity score: 1 – Clear or almost clear; 2 – Mild; 3 – Moderate; 4 - Severe|Baseline and Weeks 4, 8 and 12|||Percentage of participants|||Number
758561|NCT00617903|Secondary|Change From Baseline in Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)|Erythema intensity score: 1 – Clear or almost clear; 2 – Mild; 3 – Moderate; 4 - Severe|Baseline and Weeks 4, 8, 12 and End of Study (LOCF)|||Scores on a scale||Standard Deviation|Mean
758562|NCT00617903|Secondary|Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)|Erythema intensity score: 1 – Clear or almost clear; 2 – Mild; 3 – Moderate; 4 - Severe|At Weeks 4, 8, 12 and End of Study (LOCF)|||Percentage of participants|||Number
758563|NCT00617903|Secondary|Change From Baseline in IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF)|IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3- Mild to Moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe / Therapeutic success is defined as an IGA score of clear or minimal (0 to 1).|Baseline and Weeks 4, 8, 12 and End of Study (LOCF)|||Scores on a scale||Standard Deviation|Mean
758564|NCT00617903|Secondary|Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF)|IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3- Mild to Moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe / Therapeutic success is defined as an IGA score of clear or minimal (0 to 1).|At Weeks 4, 8, 12 and End of Study (LOCF)|||Percentage of participants|||Number
758565|NCT00617903|Secondary|Percent Change From Baseline in Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF)||Baseline and Weeks 4, 8, 12 and End of Study (LOCF)|||Percentage of Inflammatory lesions||Standard Deviation|Mean
758566|NCT00617903|Secondary|Nominal Change From Baseline in Inflammatory Lesion Count Per Participant at Weeks 4, 8 and 12||Baseline and Weeks 4, 8 and 12|||Inflammatory lesions||Standard Deviation|Mean
758567|NCT00617903|Secondary|Mean of Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF)||At Weeks 4, 8, 12 and End of Study (LOCF)|||Inflammatory lesions||Standard Deviation|Mean
758568|NCT00617903|Primary|Grouped Change From Baseline in Erythema Intensity Score at End of Study (LOCF)|Erythema intensity score: 1 – Clear or almost clear; 2 – Mild; 3 – Moderate; 4 - Severe|Baseline and End of Study (Week 12)|||Percentage of participants|||Number
758569|NCT00617903|Primary|Percentage of Participants With Investigator’s Global Assessment (IGA) Based Therapeutic Success at End of Study (LOCF)|IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3- Mild to Moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe / Therapeutic success is defined as an IGA score of clear or minimal (0 to 1).|At End of Study (Week 12)|||Percentage of participants|||Number
758570|NCT00617903|Primary|Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) Per Participant at End of Study (LOCF: Last Observation Carried Forward)||Baseline and End of Study (Week 12)|||Inflammatory lesions||Standard Deviation|Mean
758571|NCT00617929|Secondary|Acute Graft-vs-host Disease|"Percent of patients with Acute Graft-vs-host Disease - a process where T-cells present in the donor's bone marrow at the time of transplant identify the transplant patient as non-self' and attack the patient's skin, liver, stomach, and/or intestines."|Day 30-100|||percentage of participants|||Number
758572|NCT00617929|Secondary|Chimerism|Occurrence of genetically distinct cell types in a single organism|Day 28 post transplantation|||percentage of donor cells||Full Range|Median
758573|NCT00617929|Secondary|Survival|Percent of patients alive from beginning of study to one year post transplantation|One year post transplantation|||percentage of participants|||Number
758574|NCT00617929|Secondary|Time to Primary Neutrophil Engraftment|Time to primary neutrophil engraftment is defined as the percent of patients with an absolute neutrophil count (ANC) of 500 or more neutrophils in a cubic millimeter of blood.|Day 42 post transplantation|||percentage of participants|||Number
758575|NCT00617929|Secondary|Treatment-related Death|Percent of patients who died related to the treatment in this study.|Day 100 post transplantation|||percentage of participants|||Number
758576|NCT00617929|Primary|Survival at 100 Days Post Transplant|Percent of patients alive from beginning of study to Day 100 post transplantation|Day 100 post transplantation|||percentage of participants|||Number
758577|NCT00617929|Primary|Rate of Sustained Donor Engraftment|Rate of Sustained Donor Engraftment is defined as the percent of paticipants with an absolute neutrophile count (ANC) of 500 or more without a subsequent graft rejection.|Day 42 post transplantation|||percentage of participants|||Number
758578|NCT00617942|Secondary|Patients Affected by Toxicities of Regimen During Treatment, Including Grade >2 Neurotoxicity the Incidence of Subclinical and Clinical Cardiac Toxicity|Please note that these events represent toxicities that were experienced during treatment, but that does not mean that all toxicities were indeed deemed related to study treatment.|1 year|||participants|||Number
758579|NCT00617942|Primary|Number of Patients With Complete Pathologic Response Rate, Observed Following Treatment With q3week Carboplatin, Weekly Abraxane and Weekly Trastuzumab in Resectable and Unresectable LABC;|These numbers represent patients with a RCB score of zero (0). RCB stands for residual cancer burden.|1 year|||participants|||Number
758580|NCT00617981|Secondary|Safety||3 years||||||
758581|NCT00617981|Secondary|Time to Local Recurrence.||3 years||||||
758582|NCT00617981|Secondary|Time to Definite Worsening as Per Patient-Reported Outcomes||3 years||||||
758583|NCT00617981|Secondary|Overall Survival as Measured by Time From Randomization to Death or the End of the Study.||3 years||||||
758584|NCT00617981|Primary|Progression Free Survival Will be Measured From the Date of Randomization to the First Date on Which One of the Following Occurs. o Local Recurrence o Any New Distant Intrahepatic HCC Tumor o Any New Extrahepatic HCC Tumor o Death From Any Cause||3 years|||Time to Progression (months)||95% Confidence Interval|Number
758585|NCT00618072|Secondary|Adiponectin|Total adiponectin was measured with a commercial ELISA kit (Millipore/Linco Research, St. Charles, MO) in the laboratory of Dr. Philipp Scherer.|6 months|||ug/mL||Standard Error|Mean
758586|NCT00618072|Secondary|Triglycerides|Triglycerides were measured by enzymatic immunoassay on an AU400 chemistry auto-analyzer with commercially available enzymatic reagents.|6 months|||mg/dl||Standard Error|Mean
758587|NCT00618072|Secondary|HDL|HDL was measured using two reagents homogeneous systems with selective detergents to homogenize the lipoprotein of interest.|6 months|||mg/dl||Standard Error|Mean
758588|NCT00618072|Secondary|Diastolic BP|Blood pressure was assessed using NCEP guidelines.|6 months|||mmHg||Standard Error|Mean
758589|NCT00618072|Secondary|Systolic BP|Blood pressure was assessed using NCEP guidelines.|6 months|||mmHg||Standard Error|Mean
758590|NCT00618072|Secondary|Waist Circumference||6 months|||cm||Standard Error|Mean
758591|NCT00618072|Secondary|HOMA-IR|HOMA-IR was calculated by the formula: fasting insulin (uU/mL) times fasting glucose (mg/L) divided by 22.5.|6 months|||HOMA-IR score||Standard Error|Mean
758592|NCT00618072|Secondary|Body Weight|Body weight measurement was performed three times and averaged by a single study coordinator.|6 months|||kg||Standard Error|Mean
758593|NCT00618072|Primary|Fasting Insulin|Insulin was determined with a Siemens Immulite assay with respective intra-and inter-CV's 5.7 and 5.9%, and no cross reactivity to pro-insulin.|6 months|The final data-set consisted of 44 study participants, after exclusion of two study completers due to clinical conditions which appeared de novo (asthma requiring high dose prednisone and growth hormone deficiency diagnosed mid-study) - applicable to all study outcomes.||uIU/mL||Standard Error|Mean
758594|NCT00610311|Secondary|Number of Participants Who Develop Anti-mouse T Cell Receptor (TCR) Antibodies|Blood samples are collected from the patient and an immunological test is conducted in the laboratory to determine if the patient has generated antibodies against the mouse T-cell receptor which is part of the anti-gp100 cells.|1 month|This outcome measure was not done because the study was terminated due to low accrual.|||||
758595|NCT00610311|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|18.5 months|||Participants|||Number
758596|NCT00610311|Secondary|Number of Participants With in Vivo Survival of T-cell Receptor (TCR) Gene-engineered Cells.|T cell receptor (TCR) and vector presence will be quantitated in peripheral blood mononuclear cells (PBMC) samples using established polymerase chain reaction (PCR) techniques. This will provide data to estimate the in vivo survival of lymphocytes derived from the infused cells.|1 month|This outcome measure was not done because the study was terminated due to low accrual.|||||
758597|NCT00610311|Primary|Number of Participants With Metastatic Melanoma Who Develop Clinical Tumor Regression (CR or PR)|Clinical tumor response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 criteria. Complete response (CR) is a disappearance of all target lesions. Partial response (PR) is a 30% decrease in lesions taking as reference the baseline sum longest diameter (LD). For details about the RECIST criteria see the protocol link module.|4-6 weeks after treatment and then monthly for approximately 3 to 4 months or until off study criteria are met|||Participants|||Number
758647|NCT00610714|Secondary|Overall Survival (Number of Deaths)|Interval between date of randomization and death due to any cause. Analysis was based on January 31, 2010 data cut-off and was performed with patients in ITT analysis set who received AZD0530 175mg or Placebo 175mg. At this time, data were still immature and median overall survival was not reached. Number of deaths is presented instead|Date of randomization to death due to any cause|||Participants|||Number
758598|NCT00610363|Secondary|Number of Gout Flare Days With Participant’s Pain Score of 5 or More (From Daily Diary) Per Month Per Participant From Day 1 to Day 84 (Week 12)|Participants were asked to complete a telephone diary by calling the IVRS daily beginning at the baseline visit (Day 1) through the follow-up visit (Day 141) and reported their general well-being, gout symptoms, and weekly study drug administrations. At the onset of pain from a gout flare, participants were to answer additional diary questions regarding their gout flare and had to continue daily flare assessments until they reported the flare had ended. If a flare occurred just prior to the follow-up visit (Day 141), participants were to continue completing the daily diary until the flare resolved. Gout flare pain was assessed on a scale from 0 to 10 (with 0=no pain and 10=severe pain) within the past 24 hours.|Day 1 (Baseline) to Day 84 (Week 12)|Full analysis set (FAS) that included all randomized participants who received any study medication and was based on treatment allocated by IVRS at randomization (as randomized).||Gout flare days||Standard Deviation|Mean
758599|NCT00610363|Secondary|Number of Gout Flare Days With Participant’s Pain Score of 5 or More (From Daily Diary) Per Participant From Day 1 to Day 84 (Week 12)|Participants were asked to complete a telephone diary by calling the IVRS daily beginning at the baseline visit (Day 1) through the follow-up visit (Day 154) and reported their general well-being, gout symptoms, and weekly study drug administrations. At the onset of pain from a gout flare, participants were to answer additional diary questions regarding their gout flare and had to continue daily flare assessments until they reported the flare had ended. If a flare occurred just prior to the follow-up visit (Day 154), participants were to continue completing the daily diary until the flare resolved. Gout flare pain was assessed on a scale from 0 to 10 (with 0=no pain and 10=severe pain) within the past 24 hours.|Day 1 (Baseline) to Day 84 (Week 12)|Full analysis set (FAS) that included all randomized participants who received any study medication and was based on treatment allocated by IVRS at randomization (as randomized).||Gout flare days||Standard Deviation|Mean
758600|NCT00610363|Secondary|Mean Number of Gout Flare Days Per Month Per Participant From Day 1 to Day 84 (Week 12)|Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain, and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Mean number of gout flare days per month per participant was reported for this outcome measure.|Day 1 (Baseline) to Day 84 (Week 12)|Full analysis set (FAS) that included all randomized participants who received any study medication and was based on treatment allocated by IVRS at randomization (as randomized).||Gout flare days||Standard Deviation|Mean
758601|NCT00610363|Secondary|Mean Number of Gout Flare Days Per Participant From Day 1 to Day 84 (Week 12)|Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain, and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Mean number of gout flare days per participant was reported for this outcome measure.|Day 1 (Baseline) to Day 84 (Week 12)|Full analysis set (FAS) that included all randomized participants who received any study medication and was based on treatment allocated by IVRS at randomization (as randomized).||Gout flare days||Standard Deviation|Mean
758602|NCT00610363|Secondary|Mean Number of Gout Flares Per Month Per Participant From Day 1 to Day 84 (Week 12)|Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain, and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Mean number of flares per month = (total number of flares observed)/ (total number of days subject was in the period/28 days).|Day 1 (Baseline) to Day 84 (Week 12)|Full analysis set (FAS) that included all randomized participants who received any study medication and was based on treatment allocated by IVRS at randomization (as randomized).||number of gout flares||Standard Deviation|Mean
758603|NCT00610363|Secondary|Percentage of Participants With at Least One Gout Flare From Day 1 to Day 84 (Week 12)|Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain; and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Percentage of participants with at least one gout flare was reported for this outcome measure.|Day 1 (Baseline) to Day 84 (Week 12)|Full analysis set (FAS) that included all randomized participants who received any study medication and was based on treatment allocated by IVRS at randomization (as randomized).||percentage of participants|||Number
758604|NCT00610363|Primary|Number of Gout Flares Per Participant Assessed From Day 1 to Day 84 (Week 12)|A gout flare was defined as participant reported acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Number of gout flares per participant was reported for this outcome measure. For drop-outs, only flares occurred before Day 84 were counted, regardless whether the flares occurred during the treatment period or not.|Day 1 (Baseline) to Day 84 (Week 12)|Full analysis set (FAS) that included all randomized participants who received any study medication and was based on treatment allocated by IVRS at randomization (as randomized).||Number of gout flares per participant||Standard Deviation|Mean
758605|NCT00610441|Secondary|Computerized Cognition Assessment: Working Memory|Cognition was assessed by a computerized cognitive testing battery consisting of neuropsychological tests that measure the cognitive domain of working memory (score range: -48 to 48), with a higher score indicating better cognition.|Baseline, Day 21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline computerized cognition efficacy assessment for working memory.||score on a scale||Standard Deviation|Mean
758927|NCT00619957|Secondary|Percent Change From Baseline in Femoral Trochanter BMD, Month 12, ITT Population.|DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis.|Baseline to Month 12|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
758606|NCT00610441|Secondary|Computerized Cognition Assessment: Visual Memory|Cognition was assessed by a computerized cognitive testing battery consisting of neuropsychological tests that measure the cognitive domain of visual memory (score range: -60 to 60), with a higher score indicating better cognition.|Baseline, Day 21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline computerized cognition efficacy assessment for visual memory.||score on a scale||Standard Deviation|Mean
758607|NCT00610441|Secondary|Computerized Cognition Assessment: Verbal Memory|Cognition was assessed by a computerized cognitive testing battery consisting of neuropsychological tests that measure the cognitive domain of verbal memory (score range: -60 to 60), with a higher score indicating better cognition.|Baseline, Day 21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline computerized cognition efficacy assessment for verbal memory.||score on a scale||Standard Deviation|Mean
758608|NCT00610441|Secondary|Computerized Cognition Assessment: Sustained Attention|Cognition was assessed by a computerized cognitive testing battery consisting of neuropsychological tests that measure the cognitive domain of sustained attention (score range -120 to 120), with a higher score indicating better cognition.|Baseline, Day 21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline computerized cognition efficacy assessment for sustained attention.||score on a scale||Standard Deviation|Mean
758609|NCT00610441|Secondary|Computerized Cognition Assessment: Reasoning|Cognition was assessed by a computerized cognitive testing battery consisting of neuropsychological tests that measure the cognitive domain of reasoning (score range: -15 to 15), with a higher score indicating better cognition.|Baseline, Day 21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline computerized cognition efficacy assessment for reasoning.||score on a scale||Standard Deviation|Mean
758610|NCT00610441|Secondary|Computerized Cognition Assessment: Reaction Time|Cognition was assessed by a computerized cognitive testing battery consisting of neuropsychological tests that measure the cognitive domain of reaction time (lowest time possible is 0 msec), with a lower reaction time indicating better cognition.|Baseline, Day 21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline computerized cognition efficacy assessment for reaction time.||msec||Standard Deviation|Mean
758611|NCT00610441|Secondary|Computerized Cognition Assessment: Speed of Processing|Cognition was assessed by a computerized cognitive testing battery consisting of neuropsychological tests that measure the cognitive domain of speed of processing (score range: -1000 to 200), with a higher score indicating better cognition.|Baseline, Day 21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline computerized cognition efficacy assessment for speed of processing.||score on a scale||Standard Deviation|Mean
758612|NCT00610441|Secondary|Computerized Cognition Assessment: Executive Functioning|Cognition was assessed by a computerized cognitive testing battery consisting of neuropsychological tests that measure the cognitive domain of executive functioning (score range: -200 to 200), with a higher score indicating better cognition.|Baseline, Day 21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline computerized cognition efficacy assessment for executive functioning.||score on a scale||Standard Deviation|Mean
758613|NCT00610441|Secondary|Computerized Cognition Assessment: Composite Memory|Cognition was assessed by a computerized cognitive testing battery consisting of neuropsychological tests that measure the cognitive domain of composite memory (score range: -120 to 120), with a higher score indicating better cognition.|Baseline, Day 21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline computerized cognition efficacy assessment for composite memory.||score on a scale||Standard Deviation|Mean
758614|NCT00610441|Secondary|Computerized Cognition Assessment: Complex Attention|Cognition was assessed by a computerized cognitive testing battery consisting of neuropsychological tests that measure the cognitive domain of complex attention (score range: 0 to 250), with a lower score indicating better cognition.|Baseline, Day 21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline computerized cognition efficacy assessment for complex attention.||score on a scale||Standard Deviation|Mean
758615|NCT00610441|Secondary|Computerized Cognition Assessment: Cognitive Flexibility|Cognition was assessed by a computerized cognitive testing (©CNS Vital Signs, Chapel Hill, NC) battery consisting of neuropsychological tests that measure the cognitive domain of cognitive flexibility (score range: -200 to 200), with a higher score indicating better cognition.|Baseline, Day 21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline computerized cognition efficacy assessment for cognitive flexibility.||score on a scale||Standard Deviation|Mean
758616|NCT00610441|Secondary|Change From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Score|The TASS is a participant-administered scale to assess study drug effects in the evening. Participants respond to 18 questions about ADHD symptoms, with scores from 0=Not at all to 3=Severe. Total scores can range from 0 to 54, with a higher score indicating more severe ADHD symtoms. Baseline was defined as the score at the baseline visit prior to starting dosing for Period 1 and as the last score in the 2-week placebo wash-out period for Period 2.|Baseline and Day 7, Day 14, Day 21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline TASS efficacy assessment.||score on a scale||Standard Deviation|Mean
758648|NCT00610714|Secondary|Progression-free Survival (PFS) as Evaluated by RECIST|Interval between date of randomization and earliest date of objective disease progression per RECIST criteria or death due to any cause in the absence of progression. Analysis was based on August 31, 2009 data cut-off (78 PFS events analysis) and was performed with patients in ITT analysis set who received AZD0530 175mg or Placebo 175mg.|Date of randomization to earliest date of objective disease progression or death due to any cause (conducted when a minimum of 78 progression free survival events had occurred)|||Months||Full Range|Median
758617|NCT00610441|Secondary|Change From Baseline in Quick Inventory of Depression Symptomology - Clinician Rating (QIDS-C) Score|The QIDS-C is a clinician-administered rating scale to measure the severity of depressive symptoms within the 9 DSM-IV major depression disorder symptom (MDD) domains: depressed mood, loss of interest or pleasure, concentration/decision making, self-outlook, suicidal ideation, energy/fatigability, sleep, weight/appetite change, and psychomotor changes. There is one score (0=none to 3=severe) for each of the of the 9 domains. The total score is obtained by adding the scores for each of the 9 symptom domains. QIDS-C total scores can range from 0 to 27, with a higher score indicating more severe depression. Baseline was defined as the score at the baseline visit prior to starting dosing for Period 1 and as the last score in the 2-week placebo wash-out period for Period 2.|Baseline and Day 7, Day 14, Day 21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline QIDS-C efficacy assessment.||score on a scale||Standard Deviation|Mean
758618|NCT00610441|Secondary|Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Score|The PSQI is a participant-rated scale to assess the quality of sleep. The PSQI consists of 7 component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each component score can range from 0=better (i.e., 0 times per month) to 3=worse (i.e., 3 or more times per week). The sum of these 7 component scores yields one total score with a range of 0 (better) to 21 (worse). A total PSQI score <=5 is associated with good sleep quality; a total score >5 is associated with poor sleep quality. Baseline was defined as the score at the baseline visit prior to starting dosing for Period 1 and as the last score in the 2-week placebo wash-out period for Period 2.|Baseline and Day 7, Day 14, Day 21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline PSQI efficacy assessment.||score on a scale||Standard Deviation|Mean
758619|NCT00610441|Secondary|Change From Baseline in Epworth Sleepiness Scale (ESS) Score|The ESS is an 8-item scale used to assess sleepiness. The test consists of a list of 8 situations in which participants rate their tendency to become sleepy on a scale of 0=Would never doze to 3=High chance of dozing. The scores for each of the 8 situations are added to create a total score on a scale with a range from of 0 to 24. A higher score indicates a greater degree of sleepiness. Baseline was defined as the score at the baseline visit prior to starting dosing for Period 1 and as the last score in the 2-week placebo wash-out period for Period 2.|Baseline and Day 7, Day 14, Day 21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline ESS efficacy assessment.||score on a scale||Standard Deviation|Mean
758620|NCT00610441|Secondary|Percentage of Participants With Clinician Global Impression Scale - Improvement (CGI-I) Scores|The CGI-I is a 7-point clinician-rated scale for assessing the global improvement of ADHD. Scores could range from 1=Very much improved to 4=No change to 7=Very much worse, with a lower score indicating the most improvement. Analysis of CGI-I was performed using a proportional odds model. For statistical analyses, CGI-I assessments were condensed to one assessment of improvement per treatment period by taking the worst improvement score at the second and third visits within a treatment period.|Days 14-21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug, and who had at least one postbaseline CGI-I efficacy assessment.||percentage of participants|||Number
758621|NCT00610441|Secondary|Percentage of Participants With Clinician Global Impression Scale - Severity (CGI-S) Category Scores|The CGI-S is a 7-point clinician-rated scale for assessing the global severity of ADHD. Scores could range from 1=Normal, not at all ill to 7=Among the most extremely ill, with a higher score indicating more severe illness. Categorization was as follows: 1=Normal, not at all ill and Borderline mentally ill; 2=Mildly ill; 3=Moderately ill and 4=Markedly ill, Severely ill and Among the most extremely ill patients, with a higher category indicating more severe illness. Analysis of CGI-S was performed using a proportional odds model. For statistical analyses, CGI-S assessments were condensed to one assessment of severity per treatment period by taking the most severe score at the second and third visits within a treatment period.|Days 14-21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug, and who had at least one postbaseline CGI-S efficacy assessment.||percentage of participants|||Number
758622|NCT00610441|Secondary|Percentage of Participants Who Discontinue Study Drug Due to an AE|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product, whether or not related to the investigational product. AEs are reported by study drug taken at time of event and not by randomly assigned sequence.|Up to last dose of study drug (Up to 56 days)|The AST population consisted of all participants who received at least one dose of randomized study drug within at least one of the two treatment periods (excluding the placebo run-in period).||percentage of participants|||Number
758623|NCT00610441|Secondary|Percentage of Participants Who Experience At Least One Adverse Event (AE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product, whether or not related to the investigational product. AEs are reported by study drug taken at time of event and not by randomly assigned sequence.|Up to 7 days after last dose of study drug (Up to 63 days)|The All-Subjects-Treated (AST) population consisted of all participants who received at least one dose of randomized study drug within at least one of the two treatment periods (excluding the placebo run-in period).||percentage of participants|||Number
758624|NCT00610441|Secondary|Percentage of Participants With at Least a 50% Reduction From Baseline in AISRS Score|The AISRS is an 18-item clinician-rated instrument for assessing the 18 core symptoms of ADHD corresponding to the DSM-IV diagnostic symptoms for adults. Based on the clinician’s rating for each of the symptoms using a 4-point scale (0=None to 3=Severe), the AISRS total score is derived by summing the score assigned to each of the 18 symptoms. Scores can range from 0 to 54, with a higher score indicating a more severe ADHD symptoms. Baseline was defined as the score at the baseline visit prior to starting dosing for Period 1 and as the last score in the 2-week placebo wash-out period for Period 2. Reduction was defined as the relative change from the baseline score within a treatment period to post-baseline score within that treatment period.|Baseline and Day 21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug, and who had at least one postbaseline AISRS efficacy assessment.||percentage of participants|||Number
758625|NCT00610441|Secondary|Percentage of Participants With at Least a 30% Reduction From Baseline in AISRS Score|The AISRS is an 18-item clinician-rated instrument for assessing the 18 core symptoms of ADHD corresponding to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) diagnostic symptoms for adults. Based on the clinician’s rating for each of the symptoms using a 4-point scale (0=None to 3=Severe), the AISRS total score is derived by summing the score assigned to each of the 18 symptoms. Scores can range from 0 to 54, with a higher score indicating a more severe ADHD symptoms. Baseline was defined as the score at the baseline visit prior to starting dosing for Period 1 and as the last score in the 2-week placebo wash-out period for Period 2. Reduction was defined as the relative change from the baseline score within a treatment period to post-baseline score within that treatment period.|Baseline and Day 21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug, and who had at least one postbaseline AISRS efficacy assessment.||percentage of participants|||Number
758626|NCT00610441|Primary|Change From Baseline in Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Score|The AISRS is an 18-item clinician-rated instrument for assessing the 18 core symptoms of ADHD corresponding to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) diagnostic symptoms for adults. Based on the clinician’s rating for each of the symptoms using a 4-point scale (0=None to 3=Severe), the AISRS total score is derived by summing the score assigned to each of the 18 symptoms. Scores can range from 0 to 54, with a higher score indicating a more severe ADHD symptoms. Baseline was defined as the score at the baseline visit prior to starting dosing for Period 1 and as the last score in the 2-week placebo wash-out period for Period 2. For the statistical analyses, the average score from Day 14 and Day 21 was used.|Baseline (BL) and Day 7, Day 14, Day 21|The Intent-to-Treat (ITT) population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline AISRS efficacy assessment. Results are reported by the study drug being administered at time of assessment and not by randomly assigned sequence.||score on a scale||Standard Deviation|Mean
758627|NCT00610532|Primary|Quantitative EEG Recordings||end of each treatment|No data was analyzed because the study was terminated by the investigators after they decided not to continue the project|||||
758628|NCT00610649|Secondary|Part 2: Change From Baseline in the MADRS|The MADRS is a 10-item scale designed to assess the severity of depression. The questionnaire includes questions on the following symptoms: Apparent sadness, Reported sadness, Inner tension, Reduced sleep, Reduced appetite, Concentration difficulties, Lassitude, Inability to feel, Pessimistic thoughts, and Suicidal thoughts. Each of the 10 symptoms are rated on a scale of 1 to 6, with 1=absent to 6=severe. The MADRS score can range from 0 (symptoms absent) to 60 (severe depression), with a higher score indicating more severe depression.|Baseline and end of treatment (Up to Day 28)|The AST population consisted of all Part 2 participants who received at least one dose of study drug (MK-8777 or Placebo).||score on a scale||Standard Deviation|Mean
758629|NCT00610649|Secondary|Part 1: Change From Baseline in the Montgomery-Ashberg Depression Rating Scale (MADRS)|The MADRS is a 10-item scale designed to assess the severity of depression. The questionnaire includes questions on the following symptoms: Apparent sadness, Reported sadness, Inner tension, Reduced sleep, Reduced appetite, Concentration difficulties, Lassitude, Inability to feel, Pessimistic thoughts, and Suicidal thoughts. Each of the 10 symptoms are rated on a scale of 1 to 6, with 1=absent to 6=severe. The MADRS score can range from 0 (symptoms absent) to 60 (severe depression), with a higher score indicating more severe depression.|Baseline and end of treatment (Up to Day 16)|The AST population consisted of all Part 1 participants who received at least one dose of study drug (MK-8777 or Placebo).||score on a scale||Standard Deviation|Mean
758630|NCT00610649|Primary|Part 2: Number of Participants With AEs Leading to Discontinuation of Study Drug|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Discontinuation refers to discontinuation of study drug (MK-8777 or Placebo).|Up to the last dose of study drug (Up to 28 days)|The AST population consisted of all Part 2 participants who received at least one dose of study drug (MK-8777 or Placebo).||participants|||Number
758631|NCT00610649|Primary|Part 2: Number of Participants With AEs|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.|Up to 7 days following the last dose of study drug (Up to 35 days)|The AST population consisted of all Part 2 participants who received at least one dose of study drug (MK-8777 or Placebo).||participants|||Number
758632|NCT00610649|Primary|Part 1: Number of Participants With AEs Leading to Discontinuation of Study Drug|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Discontinuation refers to discontinuation of study drug (MK-8777 or Placebo).|Up to the last dose of study drug (Up to 16 days)|The AST population consisted of all Part 1 participants who received at least one dose of study drug (MK-8777 or Placebo).||participants|||Number
758633|NCT00610649|Primary|Part 1: Number of Participants With Serious Adverse Events (SAEs)|An SAE is defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.|Up to 30 days following the last dose of study drug (Up to 46 days)|The AST population consisted of all Part 1 participants who received at least one dose of study drug (MK-8777 or Placebo).||participants|||Number
758634|NCT00610649|Primary|Part 1: Number of Participants With Moderate Intensity Adverse Events (AEs)|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. A moderate intensity AE is defined as an AE that causes no significant interference with functioning.|Up to 7 days following the last dose of study drug (Up to 23 days)|The All Subjects Treated (AST) population consisted of all Part 1 participants who received at least one dose of study drug (MK-8777 or Placebo).||participants|||Number
758702|NCT00618449|Primary|Infection With Chlamydia Trachomatis Diagnosed by Use of NAATs [Nucleic Acid Amplification Test]||1-year post-treatment|Per protocol.||Participants|||Number
758635|NCT00610675|Secondary|Change From Baseline in Satisfaction With Sleep Duration Scale at Week 52|Satisfaction with Sleep Duration is a subjective number on a Visual Analog Scale recorded by the participant in an electronic sleep diary. The scale ranges from 0 to 100, where very unsatisfied is rated at 0, up to fully satisfied, rated at 100. Baseline values were calculated by averaging baseline values from base trials P05706 and P05707. Data at baseline and at week 52 were collected every morning and evening for 7 consecutive days, and these data were then averaged. Missing values were imputed by the LOCF method, where the last available assessments prior to the scheduled observation were averaged.|Baseline and Week 52|AST participants who received at least one dose of trial medication and provided adequate data entries in their electronic sleep diary||Units on a scale||Standard Deviation|Mean
758636|NCT00610675|Secondary|Change From Baseline in Quality of Sleep Scale at Week 52|Quality of Sleep is a subjective number on a Visual Analog Scale recorded by the participant in an electronic sleep diary. The scale ranges from 0 to 100, where very poor is rated at 0, up to excellent, rated at 100. Baseline values were calculated by averaging baseline values from base trials P05706 and P05707. Data at baseline and at week 52 were collected every morning and evening for 7 consecutive days, and these data were then averaged. Missing values were imputed by the LOCF method, where the last available assessments prior to the scheduled observation were averaged.|Baseline and Week 52|AST participants who received at least one dose of trial medication and provided adequate data entries in their electronic sleep diary||Units on a scale||Standard Deviation|Mean
758637|NCT00610675|Secondary|Change From Baseline in Number of Awakenings at Week 52|Number of awakenings is a subjective number recorded by the participant in an electronic sleep diary. Baseline values were calculated by averaging baseline values from base trials P05706 and P05707. Data at baseline and at week 52 were collected every morning and evening for 7 consecutive days, and these data were then averaged. Missing values were imputed by the LOCF method, where the last available assessments prior to the scheduled observation were averaged.|Baseline and Week 52|AST participants who received at least one dose of trial medication and provided adequate data entries in their electronic sleep diary||Awakenings||Standard Deviation|Mean
758638|NCT00610675|Secondary|Change From Baseline in Wake Time After Sleep Onset at Week 52|Wake time after sleep onset (WASO) is, if the planned waking time is on or after the time of final awakening, as follows: total time from falling asleep to the time of planned wake up minus the total sleep time. If the planned waking time is before the time of final awakening then WASO is as follows: total time from falling asleep to the time of actual final awakening minus the total sleep time. All times were recorded by the participant in an electronic sleep diary. Baseline values were calculated by averaging baseline values from base trials P05706 and P05707. Data at baseline and at week 52 were collected every morning and evening for 7 consecutive days, and these data were then averaged. Missing values were imputed by the LOCF method, where the last available assessments prior to the scheduled observation were averaged.|Baseline and Week 52|AST participants who received at least one dose of trial medication and provided adequate data entries in their electronic sleep diary||Minutes||Standard Deviation|Mean
758639|NCT00610675|Secondary|Change From Baseline in Sleep Latency at Week 52|Sleep Latency (SL) is the time from when the participant went to bed up to the the time the participant actually fell asleep, recorded by the participant in an electronic sleep diary. Baseline values were calculated by averaging baseline values from base trials P05706 and P05707. Data at baseline and at week 52 were collected every morning and evening for 7 consecutive days, and these data were then averaged. Missing values were imputed by the LOCF method, where the last available assessments prior to the scheduled observation were averaged.|Baseline and Week 52|AST participants who received at least one dose of trial medication and provided adequate data entries in their electronic sleep diary||Minutes||Standard Deviation|Mean
758640|NCT00610675|Secondary|Change From Baseline in Total Sleep Time at Week 52|"Total Sleep Time (TST) is a subjective time recorded by the participant in an electronic sleep diary in response to the question How much time did you actually spend sleeping?. Baseline values were calculated by averaging baseline values from base trials P05706 and P05707. Data at baseline and at week 52 were collected every morning and evening for 7 consecutive days, and these data were then averaged. Missing values were imputed by the last observation carried forward (LOCF) method, where the last available assessments prior to the scheduled observation were averaged."|Baseline and Week 52|AST participants who received at least one dose of trial medication and provided adequate data entries in their electronic sleep diary||Minutes||Standard Deviation|Mean
758641|NCT00610675|Primary|Number of Participants Who Discontinued Treatment Due to an Adverse Event|An Adverse Event (AE) is any untoward occurrence in a participant who is administered any pharmaceutical product, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding) symptom, or disease temporarily associated with the use of an IMP, whether or not it is related to the IMP.|Up to 52 weeks|AST population consisting of all enrolled participants who received at least one dose of trial medication||Participants|||Number
758642|NCT00610675|Primary|Number of Participants With an Adverse Event|An Adverse Event (AE) is any untoward occurrence in a participant who is administered any pharmaceutical product, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding) symptom, or disease temporarily associated with the use of an investigational medicinal product (IMP), whether or not it is related to the IMP.|Up to 57 weeks|All subjects treated (AST) population consisting of all enrolled participants who received at least one dose of trial medication||Participants|||Number
758643|NCT00610688|Secondary|Birthweight of Newborn Infant|Growth of the Newborn Infant as Measured by Birthweight in grams.|Measured at birth.|||Grams||Standard Deviation|Mean
758644|NCT00610688|Secondary|Growth of the Newborn Infant as Measured by Crown-heel Length and Head Circumference at Birth|Growth of the newborn infant as measured by crown-heel length in centimeters and head circumference in centimeters at birth|At delivery|||cm||Standard Deviation|Mean
758645|NCT00610688|Primary|Maternal Serum and Neonatal Serum 25-hydroxyvitamin D Measurement|Maternal serum 25-hydroxyvitamin D measurement at 12, 16, 28 weeks during pregnancy and at delivery and cord blood or neonatal serum 25-hydroxyvitamin D measurement|29 weeks|Intention to treat analysis.||nmol/L||Standard Error|Mean
758646|NCT00610701|Primary|Quadriceps Strength|measurement of quadriceps muscle strength at final followup = 1 year data at interim time points recorded, but only final reported for this purpose|(admission, 6 weeks, 3 months, 6 months) 1 year|||Nm||Standard Deviation|Mean
758649|NCT00610714|Primary|Objective Response Rate as Evaluated by Response Evaluation Criteria In Solid Tumors ( RECIST)|Number of responders (complete (CR) or partial (PR) responders). CR = disappearance of all target lesions PR = 30% decrease in the sum of the longest diamete. Analysis was based on August 31, 2009 data cut-off , and was performed with patients who had measurable disease and received AZD0530 175mg or Placebo 175mg.|Response is evaluated from randomization to objective disease progression per RECIST criteria or death due to any cause in the absence of progression (conducted when a minimum of 78 progression free survival events had occurred)|||Participants|||Number
758650|NCT00610740|Secondary|Number of Patients With Measurable Peripheral Vein Concentration of dFdC|Efficacy of the CerviPrep™ device in delivering topical gemcitabine hydrochloride to the cervix as measured by peripheral gemcitabine hydrochloride concentration levels in blood|30, 60, 90 minutes post uterine vein sample|||Participants|||Number
758651|NCT00610740|Primary|Number of Patients With Measurable Concentration of Gemcitabine Metabolites in Uterine Vein (dFdU)|Efficacy of the CerviPrep™ device in delivering topical gemcitabine hydrochloride to the cervix as measured by local (uterine vein) gemcitabine hydrochloride concentration levels in blood|30 minutes post administration|||Participants|||Number
758652|NCT00610740|Primary|Number of Patients With Measurable Concentration of Gemcitabine in Uterine Vein (dFdC)|Efficacy of the CerviPrep™ device in delivering topical gemcitabine hydrochloride to the cervix as measured by gemcitabine hydrochloride concentration levels in tissue samples.|30 Minutes After Application of Gemcitabine|||Participants|||Number
758653|NCT00610857|Secondary|Median Overall Survival (Point Estimate)|Median overall survival is the (point) estimate of the time corresponding to 50% estimated probability of survival.|Up to 44 months|||months||95% Confidence Interval|Median
758654|NCT00610857|Secondary|1-year Overall Survival (OS)|1-year survival is the estimated probability of surviving one year expressed as a percent (probability of survival is not probability of dying).|Time from initial treatment date, up to 1 year|||percentage of patients||95% Confidence Interval|Number
758655|NCT00610857|Secondary|Progression-free Survival (PFS)|Time from initial treatment date of to date of documented progression of disease progression (TTP)|Up to 44 months|Patients with stage IV melanoma (cutaneous, uveal, or mucosal) and measurable disease, most who had previously received therapy||months||95% Confidence Interval|Median
758656|NCT00610857|Primary|Best Objective Response Rate (BORR)|Intention to treat response rate is estimated by the proportion of patients with a best response of CR, PR, or SD by Response Evaluation Criteria in Solid Tumors [RECIST] version 1.0|Up to 44 months|Patients treated with Tremelimumab 15 mg/kg at start of C1 + IFN-2b IV 20 MU/m2/d for 5 d/wk for 4 weeks; C2 onward- IFN-2b SQ 10MU/m2/d for 3 d/wk for 4 weeks||percentage of patients||90% Confidence Interval|Number
758657|NCT00610883|Primary|Complete Remission|The number of patients who achieved a complete remission as a result of treatment|330 Days|||participants|||Number
758658|NCT00610987|Primary|Number of Participants With Total Wound Infections|The primary endpoint was infection.|at 10-14 days, six weeks, 12 weeks, and every six to eight weeks thereafter until bony union occurs.|||participants|||Number
758659|NCT00611026|Post-Hoc|Post-hoc Adverse Events (AEs)|An adverse event is any untoward medical occurrence in a clinical investigation in which the participant was administered a product or medical device; the event does not necessarily need to have a causal relationship with the treatment or usage.|Baseline up to Week 12|Safety population included all participants who were randomized and received at least 1 dose of study treatment. N=number of participants with AEs noted in other unreviewed medical chart records as performed at other departments during the clinical trial but were not included as AEs in Case Report Forms; reported post-hoc.||events|||Number
758660|NCT00611026|Secondary|Change From Baseline in Overactive Bladder Questionnaire (OAB-q): Health Related Quality of Life (HRQL) at Week 12|"HRQL domain and total raw score derived as sum of scores (6-point scale:
1=not at all/none of the time; 6=a very great deal/all of the time). Transformed score (Total HRQL or domain)=[(Highest possible raw score- Actual total raw score)/Raw score range] * 100. Higher transformed scores indicative of better HRQL. Positive change in HRQL Score indicates improvement."|Baseline, Week 12|FAS; (n)=number of participants with non-missing numerical change from baseline to the respective post-baseline value (Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.||scores on a scale||Standard Error|Least Squares Mean
758661|NCT00611026|Secondary|Change From Baseline in Overactive Bladder Questionnaire (OAB-q): Symptom Bother Score at Week 12|Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score – lowest possible value of raw score)/range]*100. Higher scores values indicative of greater symptom bother. Negative change in Symptom Bother Score indicates improvement.|Baseline, Week 12|FAS; (n)=number of participants with non-missing numerical change from baseline to the respective post-baseline value (Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.||scores on a scale||Standard Error|Least Squares Mean
758662|NCT00611026|Secondary|Change From Baseline in Urgency Perception Scale (UPS). UPS Formerly Known as Patient Perception of Urgency Scale (PPUS) in the Protocol.|Number of participants in 3-point category: improvement [≥1-point improvement]; no change; deterioration [≥1-point decrease], based on UPS score (rated on 3-point scale: 1=not able to hold urine; 3=able to finish what I am doing). Score change calculated as score at observation minus score at baseline; re-scaled to 3-point categorical variables.|Baseline, Week 1, Week, 4, Week 12|FAS; (n)=number of participants with non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.||participants|||Number
758663|NCT00611026|Secondary|Change From Baseline in Patient Perception of Bladder Condition (PPBC)|Number of participants in 4-point category: ≥2 points improvement (major improvement; negative change from baseline); 1 point improvement (minor improvement); no change; deterioration (positive change from baseline), based on PPBC score (rated on 6-point scale: 1=no problems at all; 6=many severe problems). Score change: score at observation minus score at baseline; re-scaled to 4-point categorical variables.|Baseline, Week 1, Week, 4, Week 12|FAS; (n)=number of participants with non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.||participants|||Number
760306|NCT00634569|Secondary|Number of Visits to Physician/ER Room for Acute Problems|Mean Number of visits to physician/ER room for acute problems|12 months|||Visits||Standard Deviation|Mean
758664|NCT00611026|Secondary|Diary Dry Rate: Percentage of Participants With no Urgency Urinary Incontinence (UUI) in the 3-day Bladder Diary|Diary dry rate: percentage of participants with no urgency urinary incontinence episode reported in the 3 day diary at the respective time-point; based on USS: 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).|Week 1, Week 4, Week 12|FAS; (n)=number of participants with non-missing baseline and respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.||percentage of participants|||Number
758665|NCT00611026|Secondary|Change From Baseline in Frequency-Urgency Sum (FUS) Per 24 Hours (Synonymous With USS Sum in the Study Protocol)|Frequency-Urgency Sum per 24 hours calculated as mean rating scores on the USS multiplied by the mean number of micturitions per 24 hours at that visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of participants with non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.||scores on a scale||Standard Error|Least Squares Mean
758666|NCT00611026|Secondary|Change From Baseline in Mean Urinary Sensation Scale (USS) Rating Per Micturition Per 24 Hours.|Mean USS rating calculated as the sum of rating scores on USS per 24 hours divided by the total number of micturitions per 24 hours with non-missing rating at that visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of participants with non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.||scores on a scale||Standard Error|Least Squares Mean
758667|NCT00611026|Secondary|Percent Change From Baseline of Severe Urgency Episodes Per 24 Hours|Percent change calculated as change in severe urgency episodes (USS rating ≥4 in diary ) per 24 hours at that visit divided by the baseline number of severe urgency episodes per 24 hours, multiplied by 100. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of participants with baseline severe urgency episodes >0 per 24 hours and non-missing change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.||percent change||Full Range|Median
758668|NCT00611026|Secondary|Change From Baseline in Mean Number of Severe Urgency Episodes Per 24 Hours|Mean number of severe urgency episodes (USS rating ≥4 in diary ) per 24 hours calculated as the total number of micturitions with USS ≥4 divided by total number of diary days collected at that visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine).|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of participants with baseline severe urgency episodes >0 per 24 hours and non-missing change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.||severe urgency episodes per 24 hours||Standard Error|Mean
758669|NCT00611026|Secondary|Percent Change From Baseline in Mean Number of Urgency Urinary Episodes Per 24 Hours (Urinary Sensation Scale ≥3 in the Diary)|Percent change from baseline in mean number of Urgency Urinary episodes per 24 hours (Urinary Sensation Scale ≥3 in the diary). Change calculated as UUI episodes per 24 hours at observation divided by baseline number of UUI episodes per 24 hours, multiplied by 100.|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of participants with baseline urgency episodes >0 per 24 hours and non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.||percent change||Full Range|Median
758670|NCT00611026|Secondary|Change From Baseline in Mean Number of Urgency Urinary Episodes Per 24 Hours (Urinary Sensation Scale ≥3 in the Diary)|Urgency Urinary episodes per 24 hours: total number of micturitions with Urinary Sensation Scale (USS) of ≥3 divided by total number of diary days collected at visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine).|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of participants with baseline urgency episodes >0 per 24 hours and non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.||episodes per 24 hours||Standard Error|Least Squares Mean
758671|NCT00611026|Secondary|Percent Change From Baseline of UUI Episodes Per 24 Hours|"UUI episodes per 24 hours calculated as total number of micturitions with USS of 5 in diary. USS is 5-item scale measuring urinary urgency; range is
1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as UUI episodes per 24 hours at observation divided by baseline number of UUI episodes per 24 hours, multiplied by 100."|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of participants with baseline UUI >0 per 24 hours and non-missing change from baseline to respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.||percent change||Full Range|Median
758672|NCT00611026|Secondary|Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 1 and Week 4|UUI episodes per 24 hours calculated as total number of micturitions with Urinary Sensation Scale (USS) of 5 divided by total number of diary days collected at visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).|Baseline, Week 1, Week 4|FAS; (n)=number of participants with baseline UUI >0 per 24 hours and non-missing change from baseline to respective post-baseline value (Week 1 or Week 4 [LOCF] for placebo, tolterodine ER, and fesoterodine, respectively.||episodes per 24 hours||Standard Error|Mean
758673|NCT00611026|Secondary|Percent Change From Baseline of Nocturnal Micturitions Per 24 Hours|Percent change of nocturnal micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (ie, 100%*(Week 1 or 4 or 12 - baseline)/baseline). Nocturnal micturitions are those recorded in the Bedtime section of the diary. Nocturnal (Bedtime) was defined as the time the participant went to bed until he/she arose to start the next day.|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of participants with baseline nocturnal micturitions >0 per 24 hours and non-missing change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.||percent change||Full Range|Median
760307|NCT00634569|Secondary|Days of Hospitalization Per Year|Mean Days of hospitalization per subject/year|12 months|||Days||Standard Deviation|Mean
758674|NCT00611026|Secondary|Change From Baseline in Mean Number of Nocturnal Micturitions Per 24 Hours|Mean number of nocturnal micturitions per 24 hours was calculated as the total number of all micturitions divided by the total number of diary days collected at that visit. Nocturnal micturitions are those recorded in the Bedtime section of the diary. Nocturnal (Bedtime) was defined as the time the participant went to bed until he/she arose to start the next day.|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of participants with baseline nocturnal micturitions >0 per 24 hours and non-missing change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.||nocturnal micturitions per 24 hours||Standard Error|Least Squares Mean
758675|NCT00611026|Secondary|Percent Change From Baseline of Micturitions Per 24 Hours|Percent change of micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (ie, 100%*(Week 1 or 4 or 12 - baseline)/baseline).|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of participants with non-missing percent change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.||percent change||Full Range|Median
758676|NCT00611026|Secondary|Change From Baseline in Mean Number of Micturitions Per 24 Hours|The mean number of micturitions was calculated as the total number of micturitions divided by the total number of diary days collected at that visit.|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of participants with non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.||micturitions per 24 hours||Standard Error|Least Squares Mean
758677|NCT00611026|Secondary|Change From Baseline in Mean Voided Volume Per Micturition|Mean voided volume in milliliters (mL) calculated as sum of voided volume divided by the total number of micturition episodes with a recorded voided volume greater than 0 in the 3-day diary at that visit.|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of participants with non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [Last Observation Carried Forward (LOCF)], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.||mL||Standard Error|Mean
758678|NCT00611026|Primary|Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12|UUI per 24 hours: total number of micturitions with Urinary Sensation Scale (USS) of 5 divided by total number of diary days collected at visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine).|Baseline, Week 12|Full analysis set (FAS): at least 1 dose of assigned treatment, data for at least 1 baseline or post-baseline efficacy assessment, and excluded 77 participants from 3 study sites with Good Clinical Practices (GCP) deviations (Fesoterodine N=30, Tolterodine ER N=31, Placebo N=16). Decision to exclude that data was made while the study was blinded.||episodes per 24 hours||Standard Error|Mean
758681|NCT00618332|Secondary|Changes in RQLQ: Eye|The RQLQ eye range: 0–6. Higher scores indicate a worse quality of life.|Baseline and 2 weeks|||units on a scale||Standard Deviation|Mean
758682|NCT00618332|Secondary|Changes in RQLQ: Emotional|The RQLQ emotional range: 0–6. Higher scores indicate a worse quality of life.|Baseline and 2 weeks|There were one patient in the Mometasone Furoate group with a missing value.||units on a scale||Standard Deviation|Mean
758683|NCT00618332|Secondary|Changes in RQLQ: Nasal|The RQLQ nasal range: 0–6. Higher scores indicate a worse quality of life.|Baseline and 2 weeks|||units on a scale||Standard Deviation|Mean
758684|NCT00618332|Secondary|Changes in RQLQ: Practical|The RQLQ practical range: 0–6. Higher scores indicate a worse quality of life.|Baseline and 2 weeks|||units on a scale||Standard Deviation|Mean
758685|NCT00618332|Secondary|Changes in RQLQ: Non-Nasal/Eye|The RQLQ non-nasal/eye range: 0–6. Higher scores indicate a worse quality of life.|Baseline and 2 weeks|||units on a scale||Standard Deviation|Mean
758686|NCT00618332|Secondary|Changes in RQLQ: Sleep|The RQLQ sleep range: 0–6. Higher scores indicate a worse quality of life.|Baseline and 2 weeks|||units on a scale||Standard Deviation|Mean
758687|NCT00618332|Secondary|Changes in RQLQ: Activity|The RQLQ activity range: 0–6. Higher scores indicate a worse quality of life.|Baseline and 2 weeks|||units on a scale||Standard Deviation|Mean
758688|NCT00618332|Secondary|Changes in RQLQ: Overall|The RQLQ is a disease-specific measure of a patient’s quality of life. It includes domains that measure nasal and eye symptoms as well as those of activity, sleep, non-nasal/eye symptoms, practical and emotional measures. A scale of 0–6 is used to record the patient responses, with lower scores reflecting a better quality of life. The average score of each domain is calculated as well as an overall domain score reflecting the average of all scores.|Baseline and 2 weeks|||units on a scale||Standard Deviation|Mean
758689|NCT00618332|Primary|Global Assessment|"Global Assessment: 3=significantly improved, 2=moderately improved,
1=mildly improved, 0=no change, -1=mildly worse, -2=moderately worse, and -3=significantly worse"|at week 2|There were one patient in the Mometasone Furoate group and two patients in the Placebo group with missing values.||units on a scale||Standard Deviation|Mean
758690|NCT00618371|Secondary|Proviral DNA Response, HIV-1 Sequence Variation Levels of Cell Associated HIV DNA and Genetic Variation in HIV During Raltegravir Addition in Individuals Who Have Declines in HIV|We planned to compare HIV DNA levels and HIV genetic variation in individuals with and without ≥10 fold decreases in HIV RNA. As none of the patients had a decline in viral RNA, this analysis could not be readily analyzed|4 weeks|0 participants were analyzed because no patients had ≥10 fold decrease in viral RNA. As described in patient outcome description, we would sequence patients only if a ≥10- fold decrease in viremia occurred, Since no one experienced ≥10 fold decrease in viremia, no sequencing could be performed.|||||
758691|NCT00618371|Primary|Number of Participants With HIV-1 RNA Response: ≥ 1 Log Decrease in Viral Load|HIV RNA levels were determined with a non-commercial, sensitive single copy assay for HIV. The primary outcome measure was to determine the number of individuals with ≥10fold decrease in HIV RNA|4 weeks|Number of participants based on estimates of how many will have decreased viral RNA levels. If 10 participants do not have decreased RNA, the number of patients with potential for decrease is <15% of all suppressed patients.||participants|||Number
758692|NCT00618410|Secondary|Eosinophil Influx [Post-allergen]|The number of eosinophils per 200 white blood cells was counted for each nasal secretion scraping. The percentage of eosinophils was recorded.|after antigen challenge|||percentage of white blood cells||Full Range|Median
758693|NCT00618410|Secondary|Eosinophil Influx [Pre-allergen]|The number of eosinophils per 200 white blood cells was counted for each nasal secretion scraping. The percentage of eosinophils was recorded.|before antigen challenge|||percentage of white blood cells||Full Range|Median
758694|NCT00618410|Secondary|Change From Diluent Challenge Contralateral Histamine Level at Antigen Challenge|"After collection of nasal secretions after diluent or antigen challenge, the filter paper disks were replaced in Eppendorf tubes and the disk/tube combination was weighed to record produced secretions. Three hundred microleters of 0.9% sodium chloride solution was then placed in the tubes and mediators were allowed to elute from the disks for 24 hours at 4 degrees Celsius. The eluate was then transferred to tubes and stored at -20 degrees Celsius until assayed for histamine.
Histamine was assayed by ELISA (Oxford Biomedical Research, Oxford, MI). The lower limit of detection of the assay is 2.5 ng/mL and samples below the detection limit were arbitrarily assigned a value of 1.25 ng/mL. The ipsilateral measure was taken from the challenge site.
The number reported in this outcome measure was calculated by subtracting the contralateral histamine level at diluent challenge from the analogous measure recorded after antigen challenge. Values may be positive or negative."|10 minutes post diluent challenge and 10 minutes post antigen challenge|Excludes one patient who did not complete the second crossover intervention.||ng/mL||Full Range|Median
758695|NCT00618410|Secondary|Change From Diluent Challenge Ipsilateral Histamine Level at Antigen Challenge|"After collection of nasal secretions after diluent or antigen challenge, the filter paper disks were replaced in Eppendorf tubes and the disk/tube combination was weighed to record produced secretions. Three hundred microleters of 0.9% sodium chloride solution was then placed in the tubes and mediators were allowed to elute from the disks for 24 hours at 4 degrees Celsius. The eluate was then transferred to tubes and stored at -20 degrees Celsius until assayed for histamine.
Histamine was assayed by ELISA (Oxford Biomedical Research, Oxford, MI). The lower limit of detection of the assay is 2.5 ng/mL and samples below the detection limit were arbitrarily assigned a value of 1.25 ng/mL. The ipsilateral measure was taken from the challenge site.
The number reported in this outcome measure was calculated by subtracting the ipsalateral histamine level at diluent challenge from the analogous measure recorded after antigen challenge. Values may be positive or negative."|10 minutes post diluent challenge and 10 minutes post antigen challenge|Excludes one patient who did not complete the second crossover intervention.||ng/mL||Full Range|Median
758696|NCT00618410|Secondary|Change From Diluent Challenge Ipsilateral Secretion Weight at Antigen Challenge|Fifty microliters of challenge solutions were placed on the disks, which were then applied to the nasal septum for 1 minute. Thirty seconds after removal, two preweighed filter paper disks were placed on both sides of the nasal septum for 30 seconds, collecting nasal secretions from the challenge site (ipsilateral) and the contralateral nostril. These disks were then immediately placed back into microtubes and weighed. The difference in their weight before and after challenge was the weight of produced nasal secretions, which was recorded in milligrams. Ipsilateral secretion weight for the diluent challenge was subtracted from that of the antigen challenge to compute this primary outcome measure.|10 minutes post diluent challenge and 10 minutes post antigen challenge|Excludes one patient who did not complete the second crossover intervention.||milligrams||Full Range|Median
758697|NCT00618410|Primary|Change From Diluent Challenge Contralateral Secretion Weight at Antigen Challenge|Fifty microliters of challenge solutions were placed on the disks, which were then applied to the nasal septum for 1 minute. Thirty seconds after removal, two preweighed filter paper disks were placed on both sides of the nasal septum for 30 seconds, collecting nasal secretions from the challenge site (ipsilateral) and the contralateral nostril. These disks were then immediately placed back into microtubes and weighed. The difference in their weight before and after challenge was the weight of produced nasal secretions, which was recorded in milligrams. Contralateral secretion weight for the diluent challenge was subtracted from that of the antigen challenge to compute this primary outcome measure.|10 minutes post diluent challenge and 10 minutes post antigen challenge|Excludes one patient who did not complete the second crossover intervention.||milligrams||Full Range|Median
758698|NCT00618436|Secondary|Incidence of Adverse Events||discharge; 3 and 6 months following injury||||||
758699|NCT00618436|Secondary|Disability Rating Scale (DRS)|The Disability rating scale (DRS) is frequently used in the rehabilitation literature as a measure of disability. It is a reliable, easily performed test that assesses 8 items (eye opening, verbalization, motor response, feeding, toileting, grooming, level of functioning, employability), and assigns each a numerical score ranging from 0 - 5 based on the category. The domains these 8 items are felt to assess include: alertness, cognition for self-care, dependence, and psychosocial adaptability. The scoring range is from 0-30, with increasing disability levels assigned to higher numerical values. The total DRS is then dichotomized into favorable (disability = none, mild, partial or moderate disability) and unfavorable (disability = moderately severe, severe, extremely severe, vegetative state, extreme vegetative state, death) outcomes. A DRS score of 0-6 was favorable, with any score greater than 6 categorized as unfavorable.|Discharge; 3 and 6 months following injury|All patients||units on a scale||Full Range|Mean
758700|NCT00618436|Secondary|Extended Glasgow Outcome Score|This is an 8 point validated scale that measures disability after brain injury. It is assessed through an in person exam or by phone interview at hospital discharge, 3 months and 6 months after injury. The categories are: 1 = dead; 2 = vegetative state; 3 = severe disability, low level; 4 = severe disability, high level; 5 = moderate disability, low level; 6 = moderate disability, high level; 7 = good recovery - low level; 8 = good recovery - high level. Specific questions and activities are assessed to determine into which category the patient falls.|at discharge; 3 and 6 months following injury|All patients||units on a scale||Full Range|Mean
758701|NCT00618436|Primary|Seizure Incidence|This was the number of patients in each group who demonstrated seizure activity during the course of the study|Duration of study, up to 6 months after the injury|||Participants|||Number
758704|NCT00618514|Secondary|Percentage of Subjects Reporting an Excellent Satisfaction Score at 6 Months.|Each subject completed a questionnaire to rate their satisfaction with the laser treatment. The score was reported as excellent, good, fair or poor. The best score of excellent was defined as “I am very satisfied with the laser treatment” and the worse score of poor was defined as “I am not satisfied with the laser treatment.” Each treated limb was scored by the patient at 6 months to determine the percent satisfaction at the 6-month time point.|6 months|||Percentage of participants|Participants||Number
758705|NCT00618514|Secondary|Percent Change of Subject Symptoms in Treated Limb From Post-procedure to 6 Months Using Patient Visual Analog Scale (VAS) Pain Scores.|Each subject completed a questionnaire to rate his/her pain. The scale is from 0-10 (0=no pain and 10=worst pain imaginable). Each treated limb was scored by the patient post-procedure and at 6 months to determine the improvement after treatment at the 6-month time point.|6 Months|||percentage of change|Participants|Standard Deviation|Mean
758706|NCT00618514|Secondary|Percent Change of Subject Symptoms in Treated Limb From Baseline to 6 Months Using Venous Disability Score (VDS).|VDS is a physician’s evaluation of a patient’s ability to work an eight-hour day with or without a support device (i.e., compressive therapy, limb elevation). The patient is scored on a scale of 0-3 (0=asymptomatic and 3=unable to carry out usual activities (patients activities before the onset of disability due to venous disease) even with compression and/or limb elevation). The score represents the degree of disability caused by the venous disease with the best score being 0 and the worse score being 3. Each treated limb was evaluated and scored at baseline and at 6 months.|6 Months|||percentage of change|Participants|Standard Deviation|Mean
758707|NCT00618514|Secondary|Percent Change of Subject Symptoms in Treated Limb From Baseline to 6 Months Using Venous Clinical Severity Score (VCSS).|VCSS is a physician’s evaluation of 10 pre-determined clinical signs or attributes of venous disease (pain, varicose veins, venous edema, skin pigmentation, inflammation, induration, number of active ulcers, active ulcer duration, active ulcer diameter and compression therapy). Each attribute receives a score from 0-3 (0=absent and 3=severe). The best total overall score is 0 (all ten attributes are absent) and the worse overall score is 30 (all ten attributes are severe). Each treated limb was evaluated and scored at baseline and at 6 months.|6 Months|||percentage change|Participants|Standard Deviation|Mean
758708|NCT00618514|Primary|Number of Limbs With a Device-related Serious Adverse Event Reported Over 6 Months.|Each treated limb was clinically evaluated for the presence of a device-related serious adverse event.|6 Months|||Limbs|Participants||Number
758709|NCT00618514|Primary|Number of Limbs With a Continued Absence of Flow Within the Treated Vein Segment Over 6 Months.|The absence of flow was evaluated in each treated limb and determined by ultrasound (duplex or Doppler) interrogation.|6 Months|||Limbs|Participants||Number
758710|NCT00618540|Secondary|Incidence of Grade III-IV Acute Graft-versus-host-disease (GVHD)|The occurrence of skin, gastrointestinal or liver abnormalities fulfilling the criteria of Grades II, III and/or IV acute GVHD are considered events (Appendix II). Patients without acute GvHD will be censored at the time of death or last follow-up. Patients that survive <21 days and listed as not evaluable will be excluded. Patients receiving a second transplant will be censored at the time of second transplant.|Day 100 and Month 6|||participants|||Number
758711|NCT00618540|Secondary|Platelet Engraftment|Incidence of platelet recovery and donor chimerism at Day 100.|Day 100|||participants|||Number
758712|NCT00618540|Secondary|Incidence of Chronic GVHD|Occurrence of symptoms in any organ system fulfilling the criteria of limited or extensive chronic GvHD (Appendix III), among patients surviving > 90 days with evidence of engraftment. Patients without chronic GvHD will be censored at time of death or last follow-up.|Day 100 and Month 6|||participants|||Number
758713|NCT00618540|Secondary|Incidence of Grade II-IV Acute Graft-versus-host-disease (GVHD)|The occurrence of skin, gastrointestinal or liver abnormalities fulfilling the criteria of Grades II, III and/or IV acute GVHD are considered events (Appendix II). Patients without acute GvHD will be censored at the time of death or last follow-up. Patients that survive <21 days and listed as not evaluable will be excluded. Patients receiving a second transplant will be censored at the time of second transplant.|Day 100 and Month 6|||participants|||Number
758714|NCT00618540|Secondary|Neutrophil Engraftment|Incidence of neutrophil recovery and donor chimerism at Day 100.|Day 100|||participants|||Number
758715|NCT00618540|Secondary|Transplantation-related Death|Count of patients who died by day 100 related to the transplantation.|Day 100|||participants|||Number
758716|NCT00618540|Primary|Disease-free Survival at 12 Months Post Transplantation|"This outcome is defined as survival with resolution of LCH at 12 months post transplant.
Unresolved disease for over 12 months post-transplant, progressive disease after this time period, recurrence of disease and death from any cause are considered events.
Those who survive with resolution of disease are censored at the date of last contact."|Year 1|||participants|||Number
758717|NCT00618540|Primary|Overall Survival|Count of patients alive at 1 and 3 years. Deaths from any cause are events. Surviving patients are censored at the date of last contact.|Year 1, Year 3|||participants|||Number
758718|NCT00618618|Secondary|Visual Analogue Scale Pain Intensity Rating|Participants rated pain associated with the submental area on a 100 mm horizontal axis ranging from 0 (no pain) to 100 (most severe pain possible)|Approximately 60 minutes after completion of each treatment session at Week 0, Week 4, Week 8 and Week 12|"Safety/mITT subset with available data at each time point (indicated by N)"||units on a scale||Standard Deviation|Mean
758719|NCT00618618|Secondary|Change From Baseline in the Cervicomental Angle|The cervicomental angle was measured using a profile view photograph obtained at each visit. A goniometer was used to determine the angle. Cervicomental angle measurements less than 80 degrees are excluded, due to error in measurement.|Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)|Safety/mITT subset with available data||degrees||Standard Deviation|Mean
758720|NCT00618618|Primary|Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, Weight, Vital Signs, and Physical Examinations||From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).|Safety/mITT subset||participants|||Number
758802|NCT00619177|Secondary|Patient Assessment of Efficacy|"Patient assessment of general efficacy of MOVALIS® using a 5-point scale (1 excellent; 2 very good; 3 good; 4 fair; 5 poor) was performed at visit 2.
The patients have been placed into categories according to the points on a scale."|after approximately 4 weeks of treatment|Full analysis set (FAS). This analysis was performed on all patients in FAS with available data on the global assessment of general efficacy.||Participants|||Number
758721|NCT00618618|Secondary|Change From Baseline to Each Visit in Submental Fat (SMF) Rating Scale Score|"The SMF rating scale score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.
A negative change from Baseline indicates improvement."|Baseline and Week 4, Week 8, Week 12, Week 16 (4 weeks after last treatment) and Week 24 (12 weeks after last treatment)|Safety/mITT subset||units on a scale||Standard Deviation|Mean
758722|NCT00618618|Secondary|Change From Baseline in Skin Laxity Rating|"Skin laxity assessment was based on clinical evaluation and palpation of the submental area on the following scale:
1 = no laxity; 2 = minimal laxity; 3 = moderate laxity; 4 = very lax. A negative change from Baseline indicates improvement."|Baseline and Week 4, Week 8, Week 12, Week 16 (4 weeks after last treatment) and Week 24 (12 weeks after last treatment)|Safety/mITT subset||units on a scale||Standard Deviation|Mean
758723|NCT00618618|Secondary|Percentage of Participants With an SMF Response|Response is defined as a participant with at least a 1-grade improvement in SMF Rating Scale score at Week 16 from Baseline. The SMF rating scale score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.|Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)|Safety/mITT subset with available data||percentage of participants|||Number
758724|NCT00618618|Secondary|Percentage of Participants With a Response in the Subject Global Improvement Rating|"Participants were asked to rate their total improvement or worsening in the appearance and physical feeling of their chin and neck area since before they received study treatment, whether or not they believed it was due to study treatment or to any other cause.
0 = Very much worse, 1 = Much worse, 2 = Minimally worse, 3 = No change, 4 = Minimally improved, 5 = Much improved, 6 = Very much improved.
Response is defined as any improvement, ie, a global improvement rating of 4, 5, or 6."|4 weeks after last treatment (up to 16 weeks after first dose)|Safety/mITT subset with available data||percentage of participants|||Number
758725|NCT00618618|Secondary|Change From Baseline in Subject Satisfaction With Appearance Rating Scale|"The Subject Satisfaction with Appearance Rating Scale assesses participants' satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6 where 0 = Extremely dissatisfied, 1 = Dissatisfied, 2 = Slightly dissatisfied, 3 = Neither satisfied nor dissatisfied, 4 = Slightly satisfied, 5 = Satisfied and 6 = Extremely satisfied.
A positive change from Baseline indicates improvement."|Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)|Safety/mITT subset with available data||units on a scale||Standard Deviation|Mean
758726|NCT00618618|Secondary|Change From Baseline in Submental Fat (SMF) Rating Scale Score|"The SMF rating scale score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.
A negative change from Baseline indicates improvement."|Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)|Safety/mITT subset with available data||units on a scale||Standard Deviation|Mean
758727|NCT00618618|Primary|Number of Participants With Adverse Events|"The investigator determined the relationship of each adverse event to the administration of study drug.
Severity of adverse events was determined using the following scale:
Mild: The participant is aware of a sign or symptom, but it is easily tolerated
Moderate: Discomfort or interference with usual activity
Severe: Incapacitating, with inability to engage in usual activity.
A serious AE (SAE) was defined as an event that may constitute a significant medical hazard or side-effect, regardless of the investigator or sponsor’s opinion regarding relatedness to study material. Serious events included, but were not limited to, any event that:
was fatal
was life-threatening
required inpatient hospitalization or prolongation of existing hospitalization
resulted in persistent or significant disability/incapacity
was a congenital anomaly/birth defect
other significant medical hazard"|From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).|Safety/miTT subset||participants|||Number
758728|NCT00618722|Primary|Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, Weight, Vital Signs, and Physical Examinations||From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).|Safety/mITT population||participants|||Number
758729|NCT00618722|Secondary|Change From Baseline in the Cervicomental Angle|The cervicomental angle was measured using a profile view photograph obtained at each visit. A goniometer was used to determine the angle. Cervicomental angle measurements less than 80 degrees are excluded, due to error in measurement.|Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)|Safety/mITT population with available data||degrees||Standard Deviation|Mean
758730|NCT00618722|Secondary|Change From Baseline in Skin Laxity Rating|"Skin laxity assessment was based on clinical evaluation and palpation of the submental area on the following scale:
1 = no laxity; 2 = minimal laxity; 3 = moderate laxity; 4 = very lax. A negative change from Baseline indicates improvement."|Baseline and Week 4, Week 8, Week 12, Week 16 (4 weeks after last treatment) and Week 24 (12 weeks after last treatment)|Safety/mITT population with available data||units on a scale||95% Confidence Interval|Least Squares Mean
758731|NCT00618722|Secondary|Percentage of Participants With a Response in the Subject Global Improvement Rating|"Participants were asked to rate their total improvement or worsening in the appearance and physical feeling of their chin and neck area since before they received study treatment, whether or not they believed it was due to study treatment or to any other cause.
0 = Very much worse, 1 = Much worse, 2 = Minimally worse, 3 = No change, 4 = Minimally improved, 5 = Much improved, 6 = Very much improved.
Response is defined as any improvement, ie, a global improvement rating of 4, 5, or 6."|4 weeks after last treatment (up to 16 weeks after first dose)|Safety/mITT population||percentage of participants|||Number
758732|NCT00618722|Secondary|Change From Baseline in Subject Satisfaction With Appearance Rating Scale|The Subject Satisfaction with Appearance Rating Scale assesses participants' satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6 where 0 = Extremely dissatisfied, 1 = Dissatisfied, 2 = Slightly dissatisfied, 3 = Neither satisfied nor dissatisfied, 4 = Slightly satisfied, 5 = Satisfied and 6 = Extremely satisfied. A positive change from Baseline indicates improvement.|Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)|Safety/mITT population with available data||units on a scale||Standard Deviation|Mean
760308|NCT00634569|Secondary|Days of School/Usual Activities Missed Per Year|Mean Days of school/usual activities missed per subject/year|12 months|||Days||Standard Deviation|Mean
758733|NCT00618722|Secondary|Change From Baseline in Submental Fat (SMF) Rating Scale Score|"The SMF rating scale score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.
A negative change from Baseline indicates improvement."|Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)|Safety/mITT population with available data||units on a scale||Standard Deviation|Mean
758734|NCT00618722|Primary|Number of Participants With Adverse Events|"The investigator determined the relationship of each adverse event to the administration of study drug.
Severity of adverse events was determined using the following scale:
Mild: The participant is aware of a sign or symptom, but it is easily tolerated
Moderate: Discomfort or interference with usual activity
Severe: Incapacitating, with inability to engage in usual activity.
A serious AE (SAE) was defined as an event that may constitute a significant medical hazard or side-effect, regardless of the investigator or sponsor’s opinion regarding relatedness to study material. Serious events included, but were not limited to, any event that:
was fatal
was life-threatening
required inpatient hospitalization or prolongation of existing hospitalization
resulted in persistent or significant disability/incapacity
was a congenital anomaly/birth defect
other significant medical hazard"|From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).|Safety and Modified Intent to Treat (mITT) population including all randomized participants who received at least 1 dose of study drug and who had at least 1 post-baseline observation.||participants|||Number
758735|NCT00618748|Secondary|Change From Baseline to in QTcF at Week 24 or Week 48 Endpoint|Time from electrocardiogram Q wave to the end of the T wave corresponding to electrical systole, fixed correction factor (QTcF interval)|baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)|Participants with non-missing baseline value and the specified visit result.||millisecond (msec)||Standard Deviation|Mean
758736|NCT00618748|Secondary|Change From Baseline in Prolactin at Week 24 or Week 48 Endpoint||baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)|Participants with non-missing baseline value and the specified visit result.||microgram/Liter||Standard Deviation|Mean
758737|NCT00618748|Secondary|Change From Baseline in Hemoglobin (HbA1c) at Week 24 or Week 48 Endpoint|HbA1c is a test that measures the amount of glycated hemoglobin in the blood over prolonged periods of time.|baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)|Participants with non-missing baseline value and the specified visit result.||percentage of glycated hemoglobin||Standard Deviation|Mean
758738|NCT00618748|Secondary|Percentage of Participants With Extra-Pyramidal Symptoms (EPS) at Week 24 or Week 48|EPS symptoms measured by DIEPSS are grouped into 4 categories: Parkinsonism, akathisia, dystonia, and dyskinesia. Severity ranges from level 0 (none, normal) to 4 (severe). A participant is deemed to have EPS at endpoint if they have an abnormal endpoint. Normal baseline Parkinsonism is defined as a score not ≥3 on 1 item or ≥2 on 2 items; abnormal endpoint is a score ≥3 on 1 item or ≥2 on 2 items, or an increase of 3 on Parkinsonism total. Normal baseline akathisia, dystonia and dyskinesia is defined as a score <2; abnormal endpoint is a score ≥2 or an increase ≥2 from that baseline score.|24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)|Participants with a normal baseline and an endpoint result. For Parkinsonism, normal baseline is defined as a score not ≥3 on 1 item or ≥2 on 2 items. Normal baseline akathisia, dystonia and dyskinesia is defined as a score <2.||percentage of participants|||Number
758739|NCT00618748|Secondary|Percentage of Participants With High Suicidality at Week 24 or Week 48|The MINI module C (MINI-C) is a rating scale for severity of suicidal thoughts and behaviors. The MINI-C is composed of 12 Yes/No questions with variable scores assigned to each question. The scale ranges from 0 to 52 with higher scores indicating a greater presence of suicidal thoughts and/or behaviors. Based upon scores, suicidality is defined as Low (1-8), Medium (9-16), and High (>=17).|24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)|Participants with non-missing baseline value and the specified visit value.||percentage of participants|||Number
758740|NCT00618748|Secondary|Percentage of Participants With Emergence of Mania at Week 24 or Week 48|Emergence of mania is defined as first occurrence of score of >=15 in the YMRS total score in the post-baseline period of Acute Phase. The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.|24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)|All Randomized participants.||percentage of participants|||Number
758741|NCT00618748|Secondary|Change From Baseline in Clinical Global Improvement- Bipolar (CGI-BP) at Week 24 or Week 48 Endpoint|CGI-BP is a measure of illness severity especially adapted for bipolar illness. It allows rating of mania, depression, and overall illness. The scores for mania, depression, and overall illness each range from 1 (normal, not ill) to 7 (very seriously ill).|baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
758742|NCT00618748|Secondary|Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Week 24 or Week 48 Endpoint|The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.|baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
758743|NCT00618748|Secondary|Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 24 or Week 48 Endpoint|The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
758744|NCT00618748|Secondary|Change From Baseline in Weight at Week 24 or Week 48 Endpoint||baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)|Participants with non-missing baseline value and the specified visit result.||kilograms||Standard Deviation|Mean
758746|NCT00618748|Primary|Percentage of Participants With Adverse Events Leading to Discontinuation|An adverse event (AE) is an untoward medical event associated with the use of the study drug or study procedure, whether or not it is considered related to the study drug or study procedure. Results presented are the percentage of participants who experienced an adverse event that resulted in the discontinuation of the study.|Baseline through 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)|All randomized Participants.||percentage of participants|||Number
758747|NCT00618774|Primary|Clinically Relevant Abnormalities for Changes in Blood Pressure and Pulse Rate Due to Position Change, Seated Pulse Rate, Laboratory Parameters and ECG|Clinically relevant abnormalities for changes in blood pressure and pulse rate due to position change, seated pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as adverse events.|First administration of study treatment to 24 hours post last dosing of study treatment.|Treated set||participants|||Number
758748|NCT00618774|Secondary|Seated Blood Pressure Normalisation at Trough|"Percentage of patients when classifying their blood pressure measurements into the following classes at 6 and 12 months:
Optimal: SBP <120 mmHg and DBP <80 mmHg
Normal: SBP >=120 mmHg or DBP >=80 mmHg and SBP <130 mmHg or DBP <85 mmHg
High normal: SBP >=130 mmHg or DBP >=85 mmHg and SBP <140 mmHg or DBP <90 mmHg
No: SBP >=140 mmHg or DBP >=90 mmHg"|6 months and 12 months|FAS||percentage of participants|||Number
758749|NCT00618774|Secondary|Seated SBP Response Rate at Trough|Percentage of patients whose SBP <140 mmHg or decreased deom pseudo-baseline by >=20 mmHg after 6 and 12 months|6 months and 12 months|FAS||percentage of participants|||Number
758750|NCT00618774|Secondary|Seated DBP Response Rate at Trough|Percentage of patients whose DBP <90 mmHg or decreased from pseudo-baseline by >=10 mmHg at 6 months and 12 months|6 months and 12 months|FAS||percentage of participants|||Number
758751|NCT00618774|Secondary|Seated SBP Control Rate at Trough After 6 and 12 Months|Percentage of patients whose SBP <140 mmHg|6 months and 12 months|FAS||percentage of participants|||Number
758752|NCT00618774|Secondary|Seated DBP Control Rate at Trough After 6 and 12 Months|Percentage of patients whose DBP <90 mmHg.|6 months and 12 months|FAS||percentage of participants|||Number
758753|NCT00618774|Secondary|Change From Baseline in Seated Systolic Blood Pressure|mean reduction from pseud-baseline (after the washout) in seated systolic blood pressure|Baseline and week 20 / week 48|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after reference baseline.||mmHg||Standard Deviation|Mean
758754|NCT00618774|Secondary|Change From Baseline in Seated Diastolic Blood Pressure|Mean reduction from pseud-baseline (after the washout) in seated diastolic blood pressure|Baseline and week 20 / week 48|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after reference baseline.||mmHg||Standard Deviation|Mean
758755|NCT00618774|Secondary|Seated SBP Control Rate at Trough After 8 Weeks|Percentage of patients whose SBP <140 mmHg after 8 weeks of treatment|Week 8|FAS||percentage of participants|||Number
758756|NCT00618774|Secondary|Seated DBP Control Rate at Trough After 8 Weeks|Percentage of patients whose DBP <90 mmHg after 8 weeks of treatment|week 8|FAS||percentage of participants|||Number
758757|NCT00618774|Secondary|Change From Baseline in Seated Systolic Blood Pressure at Week 8|mean reduction from pseud-baseline (after the washout) in seated systolic blood pressure|Baseline and week 8|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after reference baseline.||mmHg||Standard Deviation|Mean
758758|NCT00618774|Secondary|Change From Baseline in Seated Diastolic Blood Pressure at Week 8|mean reduction from pseud-baseline (after the washout) in seated diastolic blood pressure|Baseline and week 8|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after reference baseline.||mmHg||Standard Deviation|Mean
758759|NCT00618774|Primary|Percentage of Participants Who Experienced Adverse Events|An adverse event is defined as any untoward medical occurrence|52 weeks|Treated set for safety, which was the analysis set including all the patients who had valid measurements after drug administration.||percentage of participants|||Number
758760|NCT00618787|Primary|Percentage Change in Wound Surface Area (cm2) at Week 4 Compared to Week 0.|At each study visit, the subject's wound surface area was measured by longest length times widest width at right angles (LxW=cm2). Compiled data were analyzed to determine the median percentage decrease in wound surface area between groups and between study visits. Results report the median percentage decrease of the wound surface area as measured by cm2, comparing wound surface area at Week 4 to Week 0.|Weeks 0 and 4|Per protocol||Percentage change||Full Range|Median
758761|NCT00618787|Secondary|Pain||5 weeks||||||
758762|NCT00618787|Primary|Prevalence of Signs of Critical Colonization, Deep Infection, and Wound Healing Between the Two Groups||5 weeks||||||
758763|NCT00618813|Secondary|Event Free Survival|Disease progression, occurrence of a second malignant neoplasm (SMN)or death will be considered an analytic event. In all other cases, the patient will be considered censored at last contact.|From enrollment to event or 10 years from enrollment, whichever occurs first||||||
758764|NCT00618813|Primary|Incidence Rate (Number of Participants) of Dose-limiting Toxicity (DLT) – Week 29 to Week 37|The incidence rate of DLT while on protocol therapy where DLT is defined as (1) Grade 3 or greater nonhematological adverse event that is possibly, probably, or likely related to therapy with the specific exception of Grade 3 or greater nausea or vomiting controlled by standard supportive care measures, Grade 3 infection and Grade 3 alopecia; or (2) Grade 4 or higher hematological AE that delays the administration of therapy at least 2 weeks.|Week 29 to week 37|Two patients were not evaluated for DLT during weeks 29-37 because those patients did not complete that segment of protocol therapy.||participants|||Number
758780|NCT00618956|Secondary|Change From Baseline in Mean Systolic Blood Pressure /Diastolic Blood Pressure for 12-hour Period Post-AM Dose at Visit 4|Change from baseline to Visit 4 in mean SBP/DBP based on ABPM is defined as the mean SBP/DBP values at Visit 4 minus the corresponding mean SBP/DBP values at baseline in the same 12-hour period post-AM dose.|4 weeks (1 week of dose-escalation, 3 weeks of 100 mg/d)|The analysis was based on Intent-To-Treat (ITT) population using Observed Cases (OC) approach.||mm Hg||Standard Error|Mean
758765|NCT00618813|Primary|Incidence Rate (Number of Participants) of Dose-limiting Toxicity (DLT) - Week 23 to Week 28|The incidence rate of DLT while on protocol therapy where DLT is defined as (1) Grade 3 or greater nonhematological adverse event that is possibly, probably, or likely related to therapy with the specific exception of Grade 3 or greater nausea or vomiting controlled by standard supportive care measures, Grade 3 infection and Grade 3 alopecia; or (2) Grade 4 or higher hematological AE that delays the administration of therapy at least 2 weeks.|Week 23 to week 28|One patient was not evaluated for DLT during weeks 23-28 because the patient did not complete that segment of therapy.||participants|||Number
758766|NCT00618813|Primary|Incidence Rate (Number of Participants) of Dose-limiting Toxicity (DLT) - Week 13 to Week 22|The incidence rate of DLT while on protocol therapy where DLT is defined as (1) Grade 3 or greater nonhematological adverse event that is possibly, probably, or likely related to therapy with the specific exception of Grade 3 or greater nausea or vomiting controlled by standard supportive care measures, Grade 3 infection and Grade 3 alopecia; or (2) Grade 4 or higher hematological AE that delays the administration of therapy at least 2 weeks.|Week 13 to week 22|One patient was not evaluated for dose-limiting toxicity during weeks 13-22 because patient did not complete that segment of protocol therapy.||participants|||Number
758767|NCT00618813|Primary|Incidence Rate (Number of Participants) of Dose-limiting Toxicity (DLT) - Enrollment to Week 12|The incidence rate of DLT while on protocol therapy where DLT is defined as (1) Grade 3 or greater nonhematological adverse event that is possibly, probably, or likely related to therapy with the specific exception of Grade 3 or greater nausea or vomiting controlled by standard supportive care measures, Grade 3 infection and Grade 3 alopecia; or (2) Grade 4 or higher hematological AE that delays the administration of therapy at least 2 weeks.|Enrollment to week 12|Any patient who receives at least one cycle of protocol therapy, or who is removed from protocol therapy partly or solely because of a dose-limiting toxicity will be evaluable for this outcome.||participants|||Number
758768|NCT00618813|Primary|Incidence of Death|Incidence of death from complications of therapy while the patient is on protocol therapy or within one month of terminating protocol therapy|Length of protocol therapy (up to 37 weeks) plus 30 days|Any patient who receives at least one cycle of protocol therapy, or who dies as a result of complications of therapy prior to completing one cycle of therapy will be evaluable for this outcome||participants|||Number
758769|NCT00618826|Other Pre-specified|Toxicity|toxicities recorded using CTCAE definitions|Duration of study||||||
758770|NCT00618826|Other Pre-specified|Overall Survival (OS) at 3 Years|proportion of participants surviving 3 years|3 years||||||
758771|NCT00618826|Secondary|Overall Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|maximum 50 months|patients with measurable disease||proportion of participants||95% Confidence Interval|Number
758772|NCT00618826|Primary|Progression-free Survival|Time from study entry to disease progression or death|maximum 50 months|||months||95% Confidence Interval|Median
758773|NCT00618839|Secondary|Viability of Allograft Tissues|Immunohistochemical staining for Ki67, a protein expressed only in proliferating cells.|At the time of allograft removal (~7 days)|Treatment for each patient was randomized such that each half of the wound site received StrataGraft or cadaver skin. Therefore, each patient received StrataGraft and cadaver allograft.||Ki67 positive cells/ total cells||Full Range|Median
758774|NCT00618839|Secondary|Appearance of Allograft Tissues|The following three point scale was used to assess the condition of skin allografts: pink and adherent (2 points); either pink or adherent but not both (1 point); or neither pink nor adherent (0 points).|StrataGraft and cadaver allograft appearance were performed every other day after placement and at the time of allograft removal and the values averaged for each subject.|Treatment for each patient was randomized such that each half of the wound site received StrataGraft or cadaver skin. Therefore, each patient received StrataGraft and cadaver allograft.||points||Standard Error|Mean
758775|NCT00618839|Primary|Percent Autograft Take on Wounds Prepared by StrataGraft™ Skin Tissue.|The percentage take of the autografted area on each treatment site based on clinical judgement of visual and tactile assessments two weeks after autografting of wounds that had been temporarily covered with StrataGraft skin tissue.|two weeks post-autografting|Intrapatient treatment sites were randomized such that each half of the wound site received StrataGraft and the other half received cadaver skin. Therefore, each patient received StrataGraft and cadaver allograft.||Percent Area of Autograft Take (%)||Standard Deviation|Mean
758776|NCT00618956|Secondary|Change From Baseline in Mean HR Following 24-hour Treatment at Visit 6|Change from baseline to Visit 6 in HR based on ABPM is defined as the mean HR value at Visit 6 minus the corresponding mean HR value at baseline in the same 24-hour period.|7 weeks (1 week of dose-escalation, 3 weeks of 100 mg/d, followed by 1 week at 150 mg/d and 2 weeks of 200 mg/d)|The analysis was based on Intent-To-Treat (ITT) population using Observed Cases (OC) approach.||bpm||Standard Error|Mean
758777|NCT00618956|Secondary|Change From Baseline in Mean Heart Rate (HR) Following 24-hour Treatment at Visit 4|Change from baseline to Visit 4 in HR based on ABPM is defined as the mean HR value at Visit 4 minus the corresponding mean HR value at baseline in the same 24-hour period.|4 weeks (1 week of dose-escalation, 3 weeks of 100 mg/d)|The analysis was based on Intent-To-Treat (ITT) population using Observed Cases (OC) approach.||bpm||Standard Error|Mean
758778|NCT00618956|Secondary|Change From Baseline in Mean SBP/DBP Following 12-hour Period Post-AM Dose at Visit 6|Change from baseline to Visit 6 in mean SBP/DBP based on ABPM is defined as the mean SBP/DBP value at Visit 6 minus the corresponding mean SBP/DBP value at baseline in the same 12-hour period post-AM dose.|7 weeks (1 week of dose-escalation, 3 weeks of 100 mg/d, followed by 1 week at 150 mg/d and 2 weeks of 200 mg/d)|The analysis was based on Intent-To-Treat (ITT) population using Observed Cases (OC) approach.||mm Hg||Standard Error|Mean
758779|NCT00618956|Primary|Change From Baseline in Mean Systolic Blood Pressure Following 12-hour Period Post-AM Dose at Visit 6|Change from baseline to Visit 6 in mean systolic blood pressure based on ABPM is defined as the mean SBP value at Visit 6 minus the corresponding mean SBP value at baseline in the same 12-hour period post-AM dose.|7 weeks (1 week of dose-escalation, 3 weeks of 100 mg/d, followed by 1 week at 150 mg/d and 2 weeks of 200 mg/d)|The analysis was based on Intent-To-Treat (ITT) population using Observed Cases (OC) approach||mm Hg||Standard Error|Mean
758781|NCT00618956|Primary|Change From Baseline in Mean Systolic Blood Pressure Following 12-hour Period Post-AM Dose at Visit 4|Change from baseline to Visit 4 in mean systolic blood pressure (SBP) based on ambulatory blood pressure monitor (ABPM) is defined as the mean SBP value at Visit 4 minus the corresponding mean SBP value at baseline in the same 12-hour period post-AM dose.|4 weeks (1 week of dose-escalation, 3 weeks of 100 mg/d)|The analysis was based on Intent-To-Treat (ITT) population using Observed Cases (OC) approach.||mm Hg||Standard Error|Mean
758782|NCT00618982|Other Pre-specified|Disease Control - mITT Population|Disease Control (DC) of a subject was defined as the proportion of patients with confirmed Complete Response (CR), Partial Response (PR) or Stable Disease (SD) as their best response observed (by independent central assessment) during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST version 1.0) criteria. Confirmed CR was defined as disappearance of tumor, PR was defined as a decrease of at least 30% in the sum of tumor lesion sizes, and SD was defined as steady state of disease.|Radiological assessments were performed every 8 weeks (2 cycles) from start of the treatment. After completion of 6 cycles of treatment at the highest tolerated dose level, assessments were performed every 12 weeks for up to 34 months.|The population for the analysis of primary efficacy variable was the modified intent-to-treat (mITT) population defined as the patients treated for at least 6 months with 4 months at their highest tolerated dose.||Participants|||Number
758783|NCT00618982|Other Pre-specified|Tumor Response - mITT Population|Tumor Response of a subject was defined as the best tumor response observed (by independent central assessment) during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST version 1.0) criteria. Confirmed Complete Response (CR) was defined as disappearance of tumor, Partial Response (PR) was defined as a decrease of at least 30% in the sum of target lesions, Stable Disease (SD) was defined as steady state of disease, and Progressive Disease (PD) was defined as at least a 20% increase in the sum of measured lesions or appearance of new lesions.|Radiological assessments were performed every 8 weeks (2 cycles) from start of the treatment. After completion of 6 cycles of treatment at the highest tolerated dose level, assessments were performed every 12 weeks for up to 34 months.|The population for the analysis of primary efficacy variable was the modified intent-to-treat (mITT) population defined as the patients treated for at least 6 months with 4 months at their highest tolerated dose.||Participants|||Number
758784|NCT00618982|Secondary|Time to Progression (TTP)|Time to progression (TTP) was defined as the time from start of study medication to the first documented disease progression per RECIST (by independent radiological assessment) or clinical progression as per investigator assessment whichever occurred first. For patients who had not progressed at the time of analysis or died before progression, TTP was censored at their last date of evaluable scan.|Radiological assessments were performed every 8 weeks (2 cycles) from start of the treatment. After completion of 6 cycles of treatment at the highest tolerated dose level, assessments were performed every 12 weeks for up to 34 months.|Intent-to treat (ITT).||months||95% Confidence Interval|Median
758785|NCT00618982|Secondary|Progression-free Survival (PFS)|Progression-free survival (PFS) was defined as the time from start of study medication to the first documented disease progression per RECIST (by independent radiological assessment) or clinical progression as per investigator assessment or death due to any cause whichever occurred first. For patients who had not recurred or died at the time of analysis, PFS was censored at their last date of evaluable scan.|Radiological assessments were performed every 8 weeks (2 cycles) from start of the treatment. After completion of 6 cycles of treatment at the highest tolerated dose level, assessments were performed every 12 weeks for up to 34 months.|Intent-to-treat (ITT).||months||95% Confidence Interval|Median
758786|NCT00618982|Secondary|Pharmacokinetics (PK) Analysis – Time to Maximum Concentration (Tmax)|Tmax was defined as a time to maximum concentration at steady-state. Parameter was calculated for sorafenib and M2, an active metabolite of sorafenib.|Blood samples were collected at screening (blank) and on day 28 of the first cycle completed at each dose level. Samples were drawn at the following time points in relation to morning dose of sorafenib: pre-dose, 2, 4, 6, 8, 10 and 12 hours post-dose.|PK Analysis Population. 40 participants in the 400 mg bid group that had Tmax calculated; 31 participants in the 600 mg bid group that had Tmax calculated; 28 participants in the 800 mg bid group that had Tmax calculated.||hours||Full Range|Median
758787|NCT00618982|Secondary|Pharmacokinetics (PK) Analysis – Maximum Observed Concentration in Plasma (Cmax)|Cmax was defined as a maximum plasma concentration at steady-state. Parameter was calculated for sorafenib and M2, an active metabolite of sorafenib.|Blood samples were collected at screening (blank) and on day 28 of the first cycle completed at each dose level. Samples were drawn at the following time points in relation to morning dose of sorafenib: pre-dose, 2, 4, 6, 8, 10 and 12 hours post-dose.|PK Analysis Population. 40 participants in the 400 mg bid group that had Cmax calculated; 31 participants in the 600 mg bid group that had Cmax calculated; 28 participants in the 800 mg bid group that had Cmax calculated.||mg/L||Geometric Coefficient of Variation|Geometric Mean
758788|NCT00618982|Secondary|Pharmacokinetics (PK) Analysis – Area Under the Drug Concentration-time Curve From Time Zero to 12 Hours Postdose (AUC(0-12),ss)|AUC(0-12),ss was defined as an area under the plasma concentration versus time curve from time zero to 12 hours post-dose. Parameter was calculated for sorafenib and M2, an active metabolite of sorafenib.|Blood samples were collected at screening (blank) and on day 28 of the first cycle completed at each dose level. Samples were drawn at the following time points in relation to morning dose of sorafenib: pre-dose, 2, 4, 6, 8, 10 and 12 hours post-dose.|PK Analysis Population. 32 participants in the 400 mg bid group that had an AUC(0-12)ss calculated; 23 participants in the 600 mg bid group that had an AUC(0-12)ss calculated; 19 participants and 20 participants in the 800 mg bid group that had an AUC(0-12)ss calculated, for sorafenib and M2 parameter respectively.||mg*h/L||Geometric Coefficient of Variation|Geometric Mean
758801|NCT00619177|Secondary|Physician Assessment of Efficacy|"Physician assessment of general efficacy of MOVALIS® using a 5-point scale (1 excellent; 2 very good; 3 good; 4 fair; 5 poor) was performed at visit 2.
The patients have been placed into categories according to the points on a scale."|after approximately 4 weeks of treatment|Full analysis set (FAS): This analysis was performed on all patients in FAS with available data on physician assessment of efficacy.||Participants|||Number
758873|NCT00619645|Primary|Number of Patients With Day 100 Transplant-related Mortality|Patients were followed for death and whether or not that death was attributed to the day 100 transplant via physician assessment for 24 months after day 100 transplant.|24 months after day 100 transplant|||Participants|||Count of Participants
758789|NCT00618982|Secondary|Pharmacokinetics (PK) Analysis – Area Under the Drug Concentration-time Curve From Time Zero to 10 Hours Postdose (AUC(0-10),ss)|AUC(0-10),ss was defined as an area under the plasma concentration versus time curve from time zero to 10 hours post-dose. Parameter was calculated for sorafenib and M2, an active metabolite of sorafenib.|Blood samples were collected at screening (blank) and on day 28 of the first cycle completed at each dose level. Samples were drawn at the following time points in relation to morning dose of sorafenib: pre-dose, 2, 4, 6, 8 and 10 hours post-dose.|PK Analysis Population. 40 participants in the 400 mg bid group that had an AUC(0-10)ss calculated; 30 participants in the 600 mg bid group that had an AUC(0-10)ss calculated; 26 participants and 27 participants in the 800 mg bid group that had an AUC(0-10)ss calculated, for sorafenib and M2 parameter respectively.||mg*h/L||Geometric Coefficient of Variation|Geometric Mean
758790|NCT00618982|Primary|Tumor Response - ITT (Intent to Treat) Population|Tumor Response of a subject was defined as the best tumor response observed (by independent central assessment) during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST version 1.0) criteria. Confirmed Complete Response (CR) was defined as disappearance of tumor, Partial Response (PR) was defined as a decrease of at least 30% in the sum of target lesions, Stable Disease (SD) was defined as steady state of disease, and Progressive Disease (PD) was defined as at least a 20% increase in the sum of measured lesions or appearance of new lesions.|Radiological assessments were performed every 8 weeks (2 cycles) from start of the treatment. After completion of 6 cycles of treatment at the highest tolerated dose level, assessments were performed every 12 weeks for up to 34 months.|The population for the efficacy analysis was the intent-to-treat (ITT) population defined as all patients who received at least one dose of study medication with at least one valid tumor assessment post-baseline.||participants|||Number
758791|NCT00618982|Primary|Best Response - mITT (Modified Intent-to-treat) Population|Best Response (Response Rate) of a subject was defined as the proportion of patients with confirmed Complete Response (CR) or Partial Response (PR) as their best response observed (by independent central assessment) during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST version 1.0) criteria. Confirmed CR was defined as disappearance of tumor and PR was defined as a decrease of at least 30% in the sum of tumor lesion sizes.|Radiological assessments were performed every 8 weeks (2 cycles) from start of the treatment. After completion of 6 cycles of treatment at the highest tolerated dose level, assessments were performed every 12 weeks for up to 34 months.|The population for the analysis of primary efficacy variable was the modified intent-to-treat (mITT) population defined as the patients treated for at least 6 months with 4 months at their highest tolerated dose.||Participants|||Number
758792|NCT00618995|Secondary|Prostaglandin I Metabolite (PGI-M)|PGI-M in the Overall 24 Hour Collection Interval Following Administration on Day 7|On Day 7 across the 24-hour urinary collection period.|Twenty-six (26) subjects (including replacements) were enrolled in this study. All available subjects (besides the 2 that were excluded due to suspected NSAID/Aspirin use) who complied with the protocol and had partial data were included in the subsequent statistical analysis models/comparisons.||pg/mg creatinine||95% Confidence Interval|Least Squares Mean
758793|NCT00618995|Primary|Urinary 11-Dehydrothromboxane B2 (11-dTxB2)|The creatinine-normalized urine levels of 11-dTxB2 on Day 7 following a 7 day course of daily dosing in the overall 24 hour collection interval|On Day 7 across the 24-hour urinary collection period.|Twenty-six (26) subjects (including replacements) were enrolled in this study. All available subjects (besides the 2 that were excluded due to suspected NSAID/Aspirin use) who complied with the protocol and had partial data were included in the subsequent statistical analysis models/comparisons.||pg/mg creatinine||95% Confidence Interval|Least Squares Mean
758794|NCT00619060|Primary|Participants With Adverse Events by Treatment.|Comparison of number of participants with adverse events by treatment.|30 Days|||participants|||Number
758795|NCT00619073|Primary|Change From Baseline in Platelet Surface Activated GPIIb-IIIa Complex at 45 Days After Intervention.|Value at 45 days after intervention minus value at baseline in platelet surface activated GPIIb-IIIa complex using flow cytometry.The types and concentrations of agonists used in the flow cytometry assays reported here were: ADP 0.5, 1, and 20 µmol/L; thrombin receptor activating peptide (TRAP) 1 and 20 µmol/L; and a combination of collagen 5 µg/mL and epinephrine 5 µmol/L. Mean Florescence Intensity (MFI) is used as unit of measure. MFI indicates relative degree of shift in fluorescence intensity of a population of platelets in arbitrary units.|Baseline and 45 days after intervention|||mean fluorescence intensity (MFI)||Standard Error|Mean
758796|NCT00619099|Primary|The Overall Improvement Rate|"Defined as proportion of patients having complete remission (CR), partial remission (PR), marrow complete remission (mCR), or hematologic improvement.
Based on Modified International Working Group Response Criteria for Altering Natural History of Myelodysplastic Syndromes.
Complete Remission: Bone marrow: ≤ 5% myeloblasts with normal maturation of all cell lines. Persistent dysplasia will be noted. Peripheral blood Hgb ≥ 11 g/dL; Platelets ≥ 100 X 109/L; Neutrophils ≥ 1.0 X 109/Lb; Blasts 0%.
Partial Remission: All CR criteria if abnormal before treatment except: Bone marrow blasts decreased by ≥ 50% over pretreatment but still > 5%.
Marrow Complete Remission: Bone marrow: ≤ 5% myeloblasts and decrease by ≥ 50% over pretreatment. Peripheral blood: if hematological improvement responses, they will be noted in addition to marrow CR.
HI Improvement: shown in increases in hemoglobin, platelet and neutrophil response."|Up to one year|Modified Intent to Treat (mITT) Population||Percentage of Participants|||Number
758799|NCT00619151|Primary|Aortic Mean Gradient|Mean gradient measured across the aortic prosthetic valve via echocardiography to determine mean pressure of blood flow across the valve.|6 months|Analysis not performed due to study termination prior to analysis period.||mmHg||Standard Deviation|Mean
758800|NCT00619151|Primary|Effective Orifice Area (EOA)|Effective Orifice Area of the prosthetic valve measured via echocardiography to determine physiological area of blood flow through the valve.|6 month evaluation|Analysis not performed due to study termination prior to analysis period.||cm^2||Standard Deviation|Mean
758803|NCT00619177|Secondary|Change From Baseline of Pain Intensity on Visual Analogue Scale|The effect of MOVALIS® on reduction of pain intensity was assessed by the change from baseline in patient assessment of pain intensity on a Visual Analogue Scale (VAS) ranging from 0 (no pain) to 100 (severe pain)|Approximately four weeks of treatment|Full analysis set (FAS): This analysis was performed on all patients in FAS with available data on pain intensity on VAS at baseline and final visit.||Units on a scale||Standard Deviation|Mean
758804|NCT00619177|Primary|Mean Change in SF 12 MCS Score From Baseline to Final Final Visit.Medical Outcomes Study 12-Item Short-Form Health Survey, Version 2|Mental Component Summary (MCS). Mean Difference final-baseline score. Worst value 0 (lowest wellbeing), best value 100 (highest wellbeing)|Baseline and final visit (approximately 4 weeks)|A total of 3569 patients from five Central and Eastern Europe (CEE) countries were entered in the study. These patients were treated with MOVALIS® therapy and formed the treated set (TS). Of these, 3473 patients completed two visits and had a baseline and final score for SF-12v2 and formed the full analysis set (FAS).||Units on a scale||Standard Deviation|Mean
758805|NCT00619177|Primary|Mean Change in Medical Outcomes Study 12-item Short-Form Health Survey, Version 2 Score From Baseline to Final Visit.|Physical Component Summary (PCS) Mean Difference final-baseline score. The Medical Outcomes Study 12-item Short-Form Health Survey, version 2 (SF-12v2) was used as the instrument to measure any changes in physical wellbeing (physical component summary, PCS) and mental wellbeing (mental component summary, MCS) in patients taking MOVALIS® therapy for approximately 4 weeks. Worst value 0 (lowest wellbeing), best value 100 (highest wellbeing)|baseline and final visit (approximately 4 weeks)|A total of 3569 patients from five Central and Eastern Europe (CEE) countries were entered in the study. These patients were treated with MOVALIS® therapy and formed the treated set (TS). Of these, 3473 patients completed two visits and had a baseline and final score for SF-12v2 and formed the full analysis set (FAS).||Units on a scale||Standard Deviation|Mean
758806|NCT00619190|Secondary|Change From Baseline in the Aberrant Behavior Checklist -Lethargy/Social Withdrawal Subscale at 12 Weeks|The Aberrant Behavior Checklist lethargy/social withdrawal subscale (ABC-SW) is the sum of ratings from 0 - not a problem at all to 3 - problem is severe in degree on 16 items within the Aberrant Behavior checklist (also described in the primary outcome measure section above). Scores can range from 0 to 48, with higher scores indicating more severe problems. The period for the rating is one week and the reference group is typically developing children of the same age and gender as the participant. Both frequency of the behaviors and severity of the problems related to them are considered. High ratings on these items reflect lack of response and interaction with other people in the child's environment.|Baseline to 12 weeks|Only 20 out of 21 total participants was analyzed in the aripriprazole group because one participant dropped out before 12 weeks and so the data was not available.||units on a scale||Standard Deviation|Mean
758807|NCT00619190|Primary|Change From Baseline in Aberrant Behavior Checklist-Irritability at 12 Weeks|The Aberrant Behavior Checklist (ABC) is a caregiver rated questionnaire for assessing problem behaviors of children over the past week relative to typically developing children of the same age. Problem behaviors are rated on a categorical scale between 0 not at all a problem and 3 problem is severe in degree. Raters are instructed to consider both the severity and the frequency of the behavior in determining how severe a problem the behavior is. Thus, if a given behavior occurs more often than in other children of the same age and sex, scores greater than or equal to 1 are warranted. The total score can range from a minimum of 0 (no problem behaviors) to a maximum of 174, higher the number the worse the symptoms.The irritability subscale consists of 15 items with a minimal score of 0 - no irritability problems to 45 - all irritability items rated as severe. A rating of 18 or more on the irritability subscale is considered clinically significant.|Baseline to 12 weeks|Only 20 out of 21 total participants were analyzed in the aripriprazole group because one participant dropped out before 12 weeks and so the data was not available.||units on a scale||Standard Deviation|Mean
758808|NCT00619190|Secondary|Clinical Global Impressions Scale - Severity Score (CGI-S)|"One of the most widely used of clinician assessment tools in psychiatry, the CGI is an observer-rated scale that measures illness severity (CGI-S).
The CGI is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (among the most severely ill patients)."|Baseline to 12 weeks|Only 20 out of 21 total participants was analyzed in the aripriprazole group because one participant dropped out before 12 weeks and so the data was not available.||units on a scale||Standard Deviation|Mean
758809|NCT00619229|Secondary|The Difference in Color Vision Between Measurements at 6 Months After Intervention and Measurements at Baseline|The difference in color vision after intervention in comparison to Baseline was assessed by the investigator as 'Changed from Normal to Pathologic', 'Finding unchanged', and 'Changed from Pathologic to Normal'.|From baseline to 6 months|Full Analysis Set (FAS)||Participants|||Number
758810|NCT00619229|Secondary|The Difference in Color Vision Between Measurements at 3 Months After Intervention and Measurements at Baseline|The difference in color vision after intervention in comparison to Baseline was assessed by the investigator as 'Changed from Normal to Pathologic', 'Finding unchanged', and 'Changed from Pathologic to Normal'.|From baseline to 3 months|Full Analysis Set (FAS)||Participants|||Number
758811|NCT00619229|Secondary|The Difference in Color Vision Between Measurements Immediately After Intervention and Measurements at Baseline|The difference in color vision after intervention in comparison to Baseline was assessed by the investigator as 'Changed from Normal to Pathologic', 'Finding unchanged', and 'Changed from Pathologic to Normal'.|From baseline to time immediately after intervention|Full Analysis Set (FAS)||Participants|||Number
758812|NCT00619229|Secondary|The Difference in Contrast Sensitivity Between Measurements at 6 Months After Intervention and Measurements at Baseline|Difference in contrast sensitivity was measured with the Pelli-Robson test, using a chart with letters arranged in groups of three. The first group has unit contrast and each subsequent group has a lower contrast. Passing a group means to read correctly at least two of the three letters. A Pelli-Robson score of 2.0 indicates normal contrast sensitivity of 100 percent. Scores less than 2.0 signify poorer contrast sensitivity. Pelli-Robson contrast sensitivity score of less than 1.5 is consistent with visual impairment and a score of less than 1.0 represents visual disability.|From baseline to 6 months|Full Analysis Set (FAS)||Unit on a scale||Standard Deviation|Mean
758874|NCT00619684|Secondary|Overall Survival|Kaplan-Meier estimate of survival|At 1 and 2 years after starting treatment with lenalidomide|Patients enrolled on trial who received lenalidomide therapy.||percentage of participants||95% Confidence Interval|Number
758813|NCT00619229|Secondary|The Difference in Contrast Sensitivity Between Measurements at 3 Months After Intervention and Measurements at Baseline|Difference in contrast sensitivity was measured with the Pelli-Robson test, using a chart with letters arranged in groups of three. The first group has unit contrast and each subsequent group has a lower contrast. Passing a group means to read correctly at least two of the three letters. A Pelli-Robson score of 2.0 indicates normal contrast sensitivity of 100 percent. Scores less than 2.0 signify poorer contrast sensitivity. Pelli-Robson contrast sensitivity score of less than 1.5 is consistent with visual impairment and a score of less than 1.0 represents visual disability.|From baseline to 3 months|Full Analysis Set (FAS)||Unit on a scale||Standard Deviation|Mean
758814|NCT00619229|Secondary|The Difference in Contrast Sensitivity Between Measurements Immediately After Intervention and Measurements at Baseline|Difference in contrast sensitivity was measured with the Pelli-Robson test, using a chart with letters arranged in groups of three. The first group has unit contrast and each subsequent group has a lower contrast. Passing a group means to read correctly at least two of the three letters. A Pelli-Robson score of 2.0 indicates normal contrast sensitivity of 100 percent. Scores less than 2.0 signify poorer contrast sensitivity. Pelli-Robson contrast sensitivity score of less than 1.5 is consistent with visual impairment and a score of less than 1.0 represents visual disability.|From baseline to time immediately after intervention|Full Analysis Set (FAS)||Unit on a scale||Standard Deviation|Mean
758815|NCT00619229|Secondary|Development of a Wet Age-related Macular Degeneration|"A wet age-related macular degeneration (AMD) is defined as the development of choroidal neovascularization of the study-eye (worse eye).
Development is categorized in Yes and No, where Yes means that a subject who had no wet AMD at Screening has developed a wet AMD at Week 29."|From baseline to 6 months|Full Analysis Set (FAS)||Participants|||Number
758816|NCT00619229|Secondary|Progression of the Dry Age-related Macular Degeneration|"Severity of the diagnosed dry age-related macular degeneration (AMD) was assessed in comparison to Baseline and classified as
Progression
Stabilization
Amelioration"|From baseline to 6 months|Full Analysis Set (FAS)||Participants|||Number
758817|NCT00619229|Secondary|The Difference in Visual Acuity Between Measurements at 6 Months After Intervention and Measurements at Baseline|Difference in visual acuity was measured with the standard ETDRS chart with letters arranged in lines of five. The first line is assumed to have letters of a specific size and each subsequent line to consist of letters of a smaller size. The subject starts reading the first line and continues reading the following lines until failing a line. Passing a line means to name at least three of the five letters correctly.|From baseline to 6 months|Full Analysis Set (FAS)||Lines read in ETDRS chart||Standard Deviation|Mean
758818|NCT00619229|Secondary|The Difference in Visual Acuity Between Measurements Immediately After Intervention and Measurements at Baseline|Difference in visual acuity was measured with the standard ETDRS chart with letters arranged in lines of five. The first line is assumed to have letters of a specific size and each subsequent line to consist of letters of a smaller size. The subject starts reading the first line and continues reading the following lines until failing a line. Passing a line means to name at least three of the five letters correctly.|From baseline to time immediately after intervention|Full Analysis Set (FAS)||Lines read in ETDRS chart||Standard Deviation|Mean
758819|NCT00619229|Primary|Difference in Visual Acuity Between Measurements at 3 Months After Drug Intervention and Measurements at Baseline (Assessed Within Early Treatment Diabetic Retinopathy Study (ETDRS) Chart)|Difference in visual acuity was measured with the standard ETDRS chart with letters arranged in lines of five. The first line is assumed to have letters of a specific size and each subsequent line to consist of letters of a smaller size. The subject starts reading the first line and continues reading the following lines until failing a line. Passing a line means to name at least three of the five letters correctly.|From baseline to 3 months|Full Analysis Set (FAS)||Lines read in ETDRS chart||Standard Deviation|Mean
758820|NCT00619242|Primary|Ki-67|Biomarker. Change in Ki-67 staining between pre- and on-therapy biopsies in patients with Barrett’s esophagus.|Two weeks|The 3 subjects underwent therapy without complications however the study was terminated due to low accrual.|||||
758821|NCT00619307|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Global Side Effects Score|This is defined as the sum of the scores for “side effects” section questions 9 to 11, corresponding to minimum possible total score of 3 and a maximum possible total score of 15. The lower the score, the better the outcome.|4 weeks|ITT||MSTCQ score (units on a scale)||95% Confidence Interval|Mean
758822|NCT00619307|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Site Reaction Score|This is defined as the sum of the scores for the “side effects” section questions 5 to 8, with a minimum possible total score of 1 and a maximum possible total score of 20. The lower the score, the better the outcome.|4 weeks|ITT||MSTCQ score (units on a scale)||95% Confidence Interval|Mean
758823|NCT00619307|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Satisfaction Score|This is defined as the sum of the scores for the “injection systems” section questions 1-9, with a minimum possible total score of 9 and a maximum possible total score of 45. The lower the score, the better the outcome.|4 weeks|ITT||MSTCQ score (units on a scale)||95% Confidence Interval|Mean
758824|NCT00619307|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Total Score|This is defined as the sum of the scores for the “injection systems” section questions 1-9 and the “side effects” section questions 1-11, with a minimum possible total score of 20 and a maximum possible total score of 100. The lower the score, the better the outcome.|4 weeks|ITT||MSTCQ score (units on a scale)||95% Confidence Interval|Mean
758825|NCT00619307|Primary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Flu-like Symptom Score|This is defined as the sum of the scores for the “side effects” section questions 1-4, with a minimum possible total score of 1 and a maximum possible total score of 20 in the MSTCQ. The lower the score, the better the outcome.|4 weeks|ITT||MSTCQ score (units on a scale)||95% Confidence Interval|Mean
758826|NCT00619359|Secondary|No Vomiting Overall (in the 120 Hours Following Initiation of Cisplatin)|The number of patients who reported No Vomiting in the 120 hours following initiation of cisplatin chemotherapy.|Overall (the 120 hours following initiation of cisplatin chemotherapy)|FAS (Full Analysis Set) patient population was used for all efficacy evaluations and included patients who: 1) received at least one dose of study therapy, 2) received cisplatin chemotherapy, and 3) had at least one post-treatment efficacy assessment. 2 patients (aprepitant group) had no vomiting data, and were excluded from this analysis.||Participants|||Number
758827|NCT00619359|Secondary|A Complete Response (no Vomiting and no Use of Rescue Therapy) in the Delayed Phase (25 to 120 Hours Following Initiation of Cisplatin).|The number of patients who reported No Vomiting and No Use of Rescue Therapy in the 25 to 120 hours following initiation of cisplatin chemotherapy.|Delayed phase (25 to 120 hours following initiation of cisplatin).|FAS (Full Analysis Set) patient population was used for all efficacy evaluations and included patients who: 1) received at least one dose of study therapy, 2) received cisplatin chemotherapy, and 3) had at least one post-treatment efficacy assessment. 1 patient (aprepitant group) had no delayed phase data, and was not included in this analysis.||Participants|||Number
758828|NCT00619359|Primary|A Complete Response (no Vomiting and no Use of Rescue Therapy) Overall (in the 120 Hours Following Initiation of Cisplatin).|The number of patients who reported No Vomiting and No Use of Rescue Therapy in the 120 hours following initiation of cisplatin chemotherapy.|Overall (in the 120 hours following initiation of cisplatin chemotherapy).|FAS (Full Analysis Set) patient population was used for all efficacy evaluations and included patients who: 1) received at least one dose of study therapy, 2) received cisplatin chemotherapy, and 3) had at least one post-treatment efficacy assessment.||Participants|||Number
758829|NCT00619385|Primary|AUC Post Final Dose||7 days|||hour*ng/mL||Standard Deviation|Mean
758830|NCT00619385|Primary|Cmax Post Final Dose|To determine the safety and PK properties of 100 mg, 150 mg and 200 mg of Proellex® taken for seven days by healthy adult female subjects.|7 days|||ng/mL||Standard Deviation|Mean
758831|NCT00619476|Secondary|Number of Participants Who Are Responders on the Clinician Global Impression of Change (CGIC) Questionnaire at EOMT Using LOCF Data|"The CGIC is a single-item questionnaire designed to provide an overall assessment of treatment from the clinician's perspective since the start of the study. It is measured on a 7-point scale, where 1=very much improved and 7=very much worse. A participant is considered a responder if they have a response of very much improved or much improved. EOMT response is defined as the score recorded at the Week13/Withdrawal visit."|EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. The CGIC analysis included a subset of the ITT Population who completed the PGIC questionnaire at the end of treatment.||participants|||Number
758832|NCT00619476|Secondary|Change From Baseline in Emotional Functioning as Assessed by the POMS-B at EOMT Using LOCF Data|The POMS-B, an emotional functioning instrument, assesses mood, tension, and other psychological symptoms and consists of 30-items assessed on a 5-point scale (0=not at all to 4=extremely). 6 summary scores are calculated: Tension/Anxiety, Depression/Rejection, Anger/Hostility, Vigor/Activity, Fatigue/Inertia, and Confusion/Bewilderment; and range from 0-20 (higher scores = more negative mood state). Analysis of this endpoint is based on the change from baseline (BL) (EOMT score minus the BL score) using an ANCOVA model with BL value, BMI, grouped center as covariates.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. Not all participants completed a POMS-B at both Baseline and Week 13/Withdrawal; as such, the number analyzed is different from the full ITT Population counts.||points on a scale||Standard Error|Least Squares Mean
758833|NCT00619476|Secondary|Change From Baseline in Quality of Life as Assessed by the SF-36 at EOMT Using LOCF Data|The SF-36 is a general health-related quality of life instrument consisting of 36 items with various response options (Yes/No, 5- to 6-point Likert scale). Summary scores are calculated for 8 domains and 2 components (physical and mental); where scores range from 0 to 100 (higher scores = better quality of life). Analysis of this endpoint is based on the change from baseline (BL) (EOMT score minus the BL score) using an ANCOVA model with BL value, BMI, grouped center as covariates.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. Not all participants completed an SF-36 at both Baseline and Week 13/Withdrawal; as such, the number analyzed is different from the full ITT Population counts.||points on a scale||Standard Error|Least Squares Mean
758834|NCT00619476|Secondary|Change From Baseline in Severity of Pain and the Impact of Pain as Assessed by the Brief Pain Inventory (BPI) at EOMT Using LOCF Data|The BPI, a general pain instrument, assesses the severity and interference of pain; and consists of 6 items assessed on an 11-point NRS (0=no impact and 10=greatest impact). 2 summary scores are calculated: BPI Severity Score (average of first 4 items) and BPI Interference Score (average of 7 responses to item 6); where each summary score ranges from 0 to 10 (0=no impact and 10=greatest impact). Analysis of this endpoint is based on the change from baseline (BL) (EOMT score minus the BL score) using an ANCOVA model with BL value, BMI, grouped center as covariates.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. Not all participants completed a BPI assessment at both Baseline and Week 13/Withdrawal; as such, the number analyzed is different from the full ITT Population counts.||points on a scale||Standard Error|Least Squares Mean
758835|NCT00619476|Secondary|Change From Baseline in the Mean Daily Dose in Milligrams of Rescue Medication at EOMT Using LOCF Data|Mean daily use of rescue medication (milligrams of acetaminophen) was calculated by determining the average number of tablets taken per day of rescue medication (Commerical Tylenol) during treatment and multiplying that by 500 mg. Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used.|Baseline and EOMT (Week 13 or early withdrawal)|ITT Population. There was one participant in the GEn 1200 mg and two in the GEn 2400 mg group who did not have enough data available to calculate the rescue mediation consumed while on treatment.||milligrams||Standard Error|Least Squares Mean
758836|NCT00619476|Secondary|Time to Onset of Sustained Improvement in the 24-hour Average Pain Intensity Score|Sustained improvement in the 24-hour average pain intensity score is defined as at least 2 consecutive days on which the 24-hour average pain intensity score is >=2 points less than the mean 24-hour average pain intensity score at baseline. Time to onset is measured from baseline and was calculated as the first day of event minus the last day of baseline and is expressed in days. Baseline score is the calculated mean of the 24-hour average pain score for each participant during the last 7 days prior to randomization.|Anytime post-baseline until date of last dose of study medication (up to Week 13)|ITT Population||days||Full Range|Median
758875|NCT00619684|Secondary|TTP|"Time to Progression (TTP): Time from start of therapy to meeting the definition of Progressive Disease (PD).
PD: 25% increase compared to the lowest value of:
Serum MP (absolute increase at least ≥ 0.5 g/dl)
Or: Urine MP (absolute increase at least > 200 mg/24h)
Or: for patients without measurable MP, Serum Free Light Chain test: the difference between involved and uninvolved FLC levels (absolute increase at least >100 mg/L)"|Up to 9 years|Patients who developed Progressive Disease while on lenalidomide treatment||Months||Full Range|Median
758837|NCT00619476|Secondary|Number of Participants Achieving Various Levels of Percent Reduction From Baseline in the Mean 24-hour Average Pain Intensity Score at EOMT Using LOCF Data|Baseline and EOMT scores are the calculated means of the 24-hour average pain scores for each participant during the last 7 days prior to randomization and EOMT, respectively. Percent reduction from baseline was calculated as the [(EOMT score minus the baseline score)divided by the baseline score], multiplied by 100. The PI-NRS is an 11-point scale (0=no pain, 10=pain as bad as you can imagine) by which a participant assesses their 24-hour average pain intensity.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. There was one participant in the GEn 1200 mg and one in the GEn 2400 mg group who did not have enough data available to calculate the percent reduction.||participants|||Number
758838|NCT00619476|Secondary|Number of Participants Who Are Responders on the Patient Global Impression of Change (PGIC) Questionnaire at EOMT Using LOCF Data|"The PGIC is a single-item questionnaire designed to provide an overall assessment of treatment from the participant's perspective since the start of the study. It is measured on a 7-point scale, where 1=very much improved and 7=very much worse. A participant is considered a responder if they have a response of very much improved or much improved. EOMT response is defined as the score recorded at the Week13/Withdrawal visit."|EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. The PGIC analysis included a subset of the ITT Population who completed the PGIC questionnaire at the end of treatment.||participants|||Number
758839|NCT00619476|Secondary|Change From Baseline in Dynamic Allodynia at EOMT Using LOCF Data|Dynamic allodynia (pain in response to a standardized light touch stimulus, a foam brush applied with light pressure to the site of maximum pain) was assessed by an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. The NRS analysis included a subset of the ITT Population who completed that NRS at both the Baseline and the Week13/Withdrawal Visit.||points on a scale||Standard Error|Least Squares Mean
758840|NCT00619476|Secondary|Change From Baseline in Pain Characteristics and Intensity as Assessed by the Short Form-McGill Pain Questionnaire (SF-MPQ) at EOMT Using LOCF Data|The SF-MPQ, a general pain instrument, assesses the characteristics and intensity of pain and consists of 15-items assessed on a 4-point scale (0=none, 1=mild, 2=moderate, and 3=severe). 3 summary scores are calculated: sensory score (sum of items 1-11, range 0-33), affective score (sum of items 12-15, range 0-12), total score (sum of items 1-15, range 0-45), where lower scores = lower pain/impact. Analysis is based on the change from baseline (BL) (EOMT score minus the BL score) using an ANCOVA model with BL value, BMI, grouped center as covariates.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. The SF-MPQ analysis included a subset of the ITT Population who completed a SF-MPQ assessment at both Baseline and the Week 13/Withdrawal Visit.||points on a scale||Standard Error|Least Squares Mean
758841|NCT00619476|Secondary|Change From Baseline in Pain Quality as Assessed by the Neuropathic Pain Scale (NPS) Summary Scores at EOMT Using LOCF Data|The NPS assesses pain qualities and consists of 11-items, 10 assessed on an 11-point NRS (0=no impact to 10=greatest impact); and 1 open-ended question not used in score calculation. 4 summary scores are calculated: NPS 10 (items 1-7, 9-11), NPS 8 (8 pain descriptor items), NPS Non-Allodynic (NA) (8 NA items), and NPS 4 (4 pain quality items); and range from 0 to 100 (0=no impact and 100=greatest impact). The analysis is based on the change from baseline (BL) (EOMT score minus the BL score) using an ANCOVA model with BL value, BMI, grouped center as covariates.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. The NPS summary included a subset of the ITT Population that completed an NPS assessment at both Baseline and Week 13/Withdrawal.||points on a scale||Standard Error|Least Squares Mean
758842|NCT00619476|Secondary|Change From Baseline in the Mean Day-time Worst Pain Intensity Score at EOMT Using LOCF Data|Day-time worst pain is defined as the participant's assessment of their worst pain between rising in the morning and going to bed at night. Participants recorded day-time worst pain in the evening before bedtime using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. There was one participant in the GEn 1220 mg group and two in the 2400 mg group who did not complete enough post-baseline evening diaries to calculate a score for the EOMT timepoint.||points on a scale||Standard Error|Least Squares Mean
758843|NCT00619476|Secondary|Change From Baseline in the Mean Current Evening Pain Intensity Score at EOMT Using LOCF Data|"Current pain is defined as the participant's assessment of pain intensity right now. Participants recorded their current evening pain intensity in the evening before bedtime using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used."|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. There was one participant in the GEn 1200 mg group and two in the 2400 mg group who did not complete enough post-baseline evening diaries to calculate a score for the EMOT timepoint.||points on a scale||Standard Error|Least Squares Mean
758844|NCT00619476|Secondary|Change From Baseline in the Mean Day-time Average Pain Intensity(API) Score at EOMT Using LOCF Data|Day-time is defined as the time between rising in the morning and going to bed at night. Participants recorded day-time API on a daily basis in the evening before bedtime using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. There was one participant in the GEn 1200 mg group and two in the 2400 mg group who did not complete enough post-baseline evening diaries to calculate an API for the EOMT timepoint.||points on a scale||Standard Error|Least Squares Mean
758876|NCT00619684|Secondary|Number of Patients Who Experience Improvement in GVHD on Lenalidomide, Defined as the Reduction in Severity of GVHD as Defined by the National Institutes of Health (NIH) Consensus Criteria||Up to 9 years|Patients who received lenalidomide on study||Participants|||Count of Participants
758845|NCT00619476|Secondary|Change From Baseline in the Mean Sleep Interference Score at EOMT Using LOCF Data|Participants assessed sleep interference due to pain on a daily basis using the 11-point NRS (0=pain does not interfere with sleep, 10=pain completely interferes with sleep). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. There was one participant in the GEn 2400 mg group and one in the 3600 mg group who did not complete enough post-baseline morning diaries to calculate a score for the EMOT timepoint.||points on a scale||Standard Error|Least Squares Mean
758846|NCT00619476|Secondary|Change From Baseline in the Mean Night-time Worst Pain Intensity Score at EOMT Using LOCF Data|Night-time worst pain is defined as the participant's assessment of their worst pain between going to bed at night and rising in the morning. Participants recorded night-time worst pain in the morning upon awakening using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. There was one participant in the GEn 2400 mg group and one in the 3600 mg group who did not complete enough post-baseline morning diaries to calculate an API for the EMOT timepoint.||points on a scale||Standard Error|Least Squares Mean
758847|NCT00619476|Secondary|Change From Baseline in the Mean Current Morning Pain Intensity Score at EOMT Using LOCF Data|"Current pain is defined as the participant's assessment of pain intensity right now. Participants recorded their current morning pain intensity in the morning upon wakening using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used."|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. There was one participant in the GEn 2400 mg group and one in the 3600 mg group who did not complete enough post-baseline morning diaries to calculate an API for the EMOT timepoint.||points on a scale||Standard Error|Least Squares Mean
758848|NCT00619476|Secondary|Change From Baseline in the Mean Night-time Average Pain Intensity (API) Score at EOMT Using LOCF Data|Night-time is defined as the time between going to bed at night and rising in the morning. Participants recorded night-time API on a daily basis in the morning upon awakening using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline wss calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. There was one participant in the GEn 2400 mg group and one in the 3600 mg group who did not complete enough post-baseline morning diaries to calculate an API for the EOMT timepoint.||points on a scale||Standard Error|Least Squares Mean
758849|NCT00619476|Primary|Change From Baseline in the Mean 24-hour Average Pain Intensity (API) Score at the End of Maintenance Treatment (EOMT) Using Last Observation Carried Forward (LOCF) Data|Baseline and EOMT values are the calculated means of the daily 24-hour API scores for each participant during the last 7 days prior to randomization (Baseline) and the earliest date of Week 13 visit/Withdrawal visit/last dose of study drug (EOMT). Participants used a hand-held diary to rate their average pain intensity over the preceding 24 hours, using an 11-point PI-Numerical Rating Scale (0=no pain, 10=pain as bad as you can imagine). LOCF was used if less than 4 days of diary data were provided. Change from baseline was calculated as EOMT score minus Baseline score.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population: all randomized participants who took at least one dose of investigational product and provided at least one post-baseline efficacy measurement.||points on a scale||Standard Error|Least Squares Mean
758850|NCT00619489|Secondary|Saturation of Receptors by Vedolizumab Before Dosing Using the MAdCAM-1-Fc Assay|The target of vedolizumab is α4β7 integrin, a receptor found on inflammatory immune cells that guides these inflammatory cells to the gut and binds to the mucosal address in cell adhesion molecule-1 (MAdCAM-1) on gut endothelial cells. The extent of the α4β7 receptor saturation by vedolizumab was assessed using the MAdCAM-1-Fc binding interference assay at time points where at least 50% of participants in the analysis set had non-missing results. MAdCAM-1-Fc is a fusion of human MAdCAM-1 with parts of a mouse monoclonal antibody. The assay measures the percentage of cells bearing α4β7 that were not saturated with vedolizumab at the time of sampling.|Days 43, 99, 155 and 267, predose|Pharmacodynamic (PD) Population included all participants who received at least 1 dose of vedolizumab and had sufficient blood sampling for estimation of PD parameters. Participants without dose modification and with available PD data at each time point are included.||percent MADCAM binding||Standard Deviation|Mean
758851|NCT00619489|Secondary|Saturation of Receptors by Vedolizumab Before Dosing on Days 1, 43, 99, 155 and 267 by ACT-1 Assay|The target of vedolizumab is α4β7 integrin, a receptor found on inflammatory immune cells that guides these inflammatory cells to the gut and binds to the Mucosal Addressin Cell Adhesion Molecule-1 (MAdCAM-1) on gut endothelial cells. The extent of the α4β7 receptor saturation by vedolizumab was assessed using the ACT-1 binding interference assay. ACT-1 is a mouse antibody similar to vedolizumab that also binds α4β7 integrin. The assay measures the percentage of cells bearing α4β7 that were not saturated with vedolizumab at the time of sampling.|Days 43, 99, 155 and 267, predose|Pharmacodynamic (PD) Population included all participants who received at least 1 dose of vedolizumab and had sufficient blood sampling for estimation of PD parameters. Participants without dose modification and with available PD data at each time point are included.||% ACT1 binding||Standard Deviation|Mean
758877|NCT00619684|Secondary|Number of Patients Requiring Dose Interruption, Dose Reduction or Discontinuance of Lenalidomide|Dose interruption, dose reduction or discontinuation of lenalidomide due to toxicity, GVHD or disease progression|Up to 9 years|Patients enrolled on the trial who received lenalidomide treatment.||Participants|||Count of Participants
758878|NCT00619684|Secondary|Adverse Events, Graded According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0|Grade 1-2 adverse events occurring in >10% of participants. Grade 3 or higher adverse events occurring in one or more participants.|Up to 30 days after completion of study treatment|||percentage of participants|||Number
758852|NCT00619489|Secondary|Serum Concentration of Vedolizumab Before Dosing|Vedolizumab serum concentrations were measured from serum samples collected for pharmacokinetic (PK) analysis within 2 hours prior to dosing. The original protocol specified that PK parameters, including but not limited to minimum plasma concentration (Cmin), were to be estimated; however, due to intrapatient dose modification with Amendment 1, it was no longer feasible to perform a full PK parameter estimation. The summaries of pre-infusion data (i.e., trough levels) are presented at time points where at least 50% of participants had quantifiable vedolizumab concentrations, using a value of 0 for results below a measurable range. This provides information on the pharmacokinetic behavior of vedolizumab when administered as long-term therapy.|Days 43, 99, 155 and 267, predose|"The PK Population included all participants who received at least 1 dose of vedolizumab and had sufficient blood sampling for estimation of PK parameters. Participants without dose modification and with available serum concentration data at each time point (indicated by n) are included."||μg/mL||Standard Deviation|Mean
758853|NCT00619489|Primary|Number of Participants With Human Anti-human Antibodies (HAHA)||Samples collected prior to dosing on Days 1, 43, 155, 267, 379, 491, and 637.|Safety analysis set||participants|||Number
758854|NCT00619489|Primary|Number of Participants With Signs and Symptoms of Progressive Multifocal Leukoencephalopathy (PML)|At every visit, before receiving study treatment participants were evaluated by clinic staff for signs of PML using a PML symptom checklist.|through Day 637|Safety analysis set||participants|||Number
758855|NCT00619489|Primary|Number of Participants With Clinically Significant Laboratory Findings|Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are enzymes in the blood.|through Day 637|Safety analysis set||participants|||Number
758856|NCT00619489|Primary|Number of Participants With Adverse Events (AEs)|"An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with the treatment. The investigator systematically collected information adequate to determine both the outcome and severity of the AE, and whether or not it was drug-related or met the criteria for classification as a serious adverse event (SAE). An SAE was defined as an AE that resulted in (or posed risk for) death, inpatient hospitalization (or prolonging hospitalization), or congenital, persistent or significant disability/incapacity.
The intensity for each AE was defined according to the following criteria:
Mild: Awareness of sign or symptom, but easily tolerated; Moderate: Discomfort enough to cause interference with normal daily activities; Severe: Inability to perform normal daily activities."|From Day 1 to Day 637|Safety analysis set, defined as all enrolled participants who received at least 1 dose of study drug. Analysis was based on the lowest dose received, rather than dose at randomization.||participants|||Number
758857|NCT00619502|Primary|Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T|"Solicited Injection Site Reactions: Pain, Erythema, Swelling, and Extensive Swelling of Vaccinated Limb. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability.
Grade 3 defined as: Pain, cries when injected limb is moved or movement of limb reduced; Erythema and Swelling, ≥ 5 cm; Extensive Swelling of Vaccinated Limb, All; Pyrexia, ≥ 39ºC; Vomiting, ≥ 6 episodes/24 hours or requiring parenteral hydration; Crying > 3 hours; Somnolence, sleeping most of time or difficult to wake up; Anorexia, refuses ≥ 3 feeds or most feeds; Irritability, inconsolable."|Day 0 up to Day 7 post-booster vaccination|Solicited reactions were assessed in all participants who received a booster dose of DTaP-IPV-Hep B-PRP~T according to the primary series received (Safety Analysis Population).||Participants|||Number
758858|NCT00619502|Primary|Geometric Mean Titers (GMTs) Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T|Antibody titers were measured by chemiluminescence detection for Hepatitis B (Hep B); Farr type radioimmunoassay for Haemophilus influenza type b (PRP); toxin neutralization test for Diphtheria (D); indirect enzyme-linked immunosorbent assay (ELISA) for Tetanus (T); neutralization assay for Poliovirus types 1, 2, and 3; and ELISA for Pertussis toxoid (PT) and Filamentous hemagglutinin (FHA).|Day 0 before and Day 30 post-booster vaccination|GMTs were assessed in all participants with any immunogenicity data who did not have any protocol violations that might have interfered with primary criteria evaluation (Per Protocol Population).||Titers||95% Confidence Interval|Geometric Mean
758859|NCT00619502|Primary|Percentage of Participants With Pre-booster Antibody Persistence and Booster Response to DTaP-IPV-Hep B-PRP~T After Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T or Pentaxim™ + Engerix B Vaccine™|Antibody titers measured by chemiluminescence detection for Hepatitis B (Hep B); Farr type radioimmunoassay for Haemophilus influenza type b (PRP); toxin neutralization for Diphtheria (D); indirect enzyme-linked immunosorbent assay (ELISA) for Tetanus (T); neutralization assay for Poliovirus types 1, 2, and 3; and ELISA for Pertussis toxoid (PT) and Filamentous hemagglutinin (FHA). Persistence and response: ≥ 10 mIU/mL for anti-Hep B, ≥ 0.15 µg/mL for anti-PRP, ≥ 0.01 IU/mL for anti-D and anti-T, ≥ 8 (1/dil) for anti-Poliovirus; and ≥ 4-fold increase from Day 0 for anti-PT and anti-FHA.|Day 0 before and Day 30 Post-booster vaccination|Antibody titers were assessed in all participants with any immunogenicity data who did not have any protocol violations that might have interfered with primary criteria evaluation.||Percentage of Participants|||Number
758860|NCT00619619|Other Pre-specified|Percentage of Participants With a Categorical Clinical Global Impressions Scale-Improvement(CGI-I) Score at Every Visit|CGI-I: 7-point clinician rated scale ranging from 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, to 7=very much worse. Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Scores above 4 reflect worsening of illness state as compared to baseline.|Baseline, Inpatient Days 1 to 4, Outpatient Days 5 to 7, Outpatient Weeks 2 through 8 and Outpatient Week >8 (or early termination)|ITT; no participants had a CGI-I score of 6 or 7, therefore only scores 1 through 5 are reported.||percentage of participants|||Number
758879|NCT00619684|Primary|Response Rate, Defined as the Number of Patients Achieving Complete Response (CR), Partial Response (PR), or Minor Response (MR)|"CR: No Monoclonal Protein (MP) in the blood AND no serum/urine MP by Immunofixation (IF < 0) AND < 5% plasma cells in bone marrow aspirate.
VGPR: More than 90% decrease of MP and urine M protein < 100 mg/d OR serum protein electrophoresis (SPEP)/urine protein electrophoresis(UPEP) negative but serum immunofixation (IFs) or IFu urine immunofixation (IFu) ) still positive.
PR: Over 50% decrease of serum MP AND > 90% reduction in 24h urinary light chain excretion or M proteinuria < 200mg/d MR: Between 25 and 49% decrease of MP in the blood AND 50-89% reduction in 24h urinary light chain excretion (monoclonal proteinuria>200 mg/d)"|Up to 9 years|||Participants|||Count of Participants
758861|NCT00619619|Secondary|Population Pharmacokinetics Dose Normalized AUC (AUC/D): Third Method|Relationship of variables (i.e., age, sex, ethnicity, and food) examined by fitting dose normalized AUC (AUC/D) values to a power model. AUC/D regressed against variables using power equation Y=A*W^b (Y=AUC/D; A=coefficient; W=variable; b=exponent). AUC values from children cohort (ages 7 to 11) combined doses=first method of analysis. AUC from adolescent cohort (ages 12 to 17) combined doses=second method of analysis. AUC values combined from both cohorts=third method of analysis. Measured as nanograms multiplied by hours divided by milliliters per milligram of dose [(ng*hr/mL)/mg of dose].|Day 1, Day 28, and Day 56|PK population; data was insufficient examine the effect of age, sex, ethnicity, and food on the PK of desvenlafaxine. Coefficient and exponent values were calculated for variable of body weight, however, the AUC/D values were not summarized as descriptive statistics.||(ng*hr/mL)/mg of dose|||Number
758862|NCT00619619|Secondary|Population Pharmacokinetics Dose Normalized AUC (AUC/D): First Method, Second Method|Relationship of variables (i.e., age, sex, ethnicity, and food) examined by fitting dose normalized AUC (AUC/D) values to a power model. AUC/D regressed against variables using power equation Y=A*W^b (Y=AUC/D; A=coefficient; W=variable; b=exponent). AUC values from children cohort (ages 7 to 11) combined doses=first method of analysis. AUC from adolescent cohort (ages 12 to 17) combined doses=second method of analysis. AUC values combined from both cohorts=third method of analysis. Measured as nanograms multiplied by hours divided by milliliters per milligram of dose [(ng*hr/mL)/mg of dose].|Day 1, Day 28, and Day 56|PK population; data was insufficient examine the effect of age, sex, ethnicity, and food on the PK of desvenlafaxine. Coefficient and exponent values were calculated for variable of body weight, however, the AUC/D values were not summarized as descriptive statistics.||(ng*hr/mL)/mg of dose|||Number
758863|NCT00619619|Primary|Area Under the Curve From Time Zero to Infinity (AUC0-∞)|AUC (0-∞) = Area under the plasma concentration versus time curve from time zero (pre-dose) to infinity. Noncompartmental PK parameter obtained using 0 to 72 hour concentration data from venous blood samples measured as nanograms multiplied by hours divided by milliliters (ng*hr/mL).|Pre-dose (0 hour) and Post-dose (0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours) on Days 28 and 56|PK population||ng*hr/mL||Standard Deviation|Mean
758864|NCT00619619|Primary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Noncompartmental PK parameter obtained using 0 to 72 hour concentration data from venous blood samples measured as hours (hr).|Pre-dose (0 hour) and Post-dose (0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours) on Days 28 and 56|PK population||hr||Standard Deviation|Mean
758865|NCT00619619|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax)|Noncompartmental PK parameter obtained using 0 to 72 hour concentration data from venous blood samples measured as hours (hr).|Pre-dose (0 hour) and Post-dose (0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours) on Days 28 and 56|PK population||hr||Standard Deviation|Mean
758866|NCT00619619|Primary|Maximum Observed Plasma Concentration (Cmax)|Noncompartmental pharmacokinetic (PK) parameter obtained using 0 to 72 hour concentration data from venous blood samples measured as nanograms per milliliter (ng/mL).|Pre-dose (0 hour) and Post-dose (0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours) on Days 28 and 56|PK population: all participants in the Safety population with available plasma concentration data from both the inpatient and outpatient phases of the study that are properly identified with respect to dosing and sampling times.||ng/mL||Standard Deviation|Mean
758867|NCT00619619|Primary|Number of Participants With Adverse Events AEs) and Serious Adverse Events (SAEs)|AEs are any untoward, undesired, or unplanned event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study treatment. The event does not need to be causally related to the study treatment. SAEs are adverse events that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in persistent or significant disability or incapacity, result in cancer, or result in a congenital anomaly or birth defect.|Baseline to Follow-up (up to Day 77)|Safety population includes all treatment-assigned participants who have taken at least 1 dose of study treatment.||participants|||Number
758868|NCT00619619|Other Pre-specified|Percentage of Participants With a Categorical Clinical Global Impressions Scale-Severity (CGI-S) Score at Every Visit|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1=normal, not ill at all, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill patients. Higher scores reflect higher severity of current illness states.|Baseline, Inpatient Days 1 to 4, Outpatient Days 5 to 7, Outpatient Weeks 2 through 8 and Outpatient Week >8 (or early termination)|ITT; no participants had a CGI-S score of 6 or 7, therefore only scores 1 through 5 are reported.||percentage of participants|||Number
758869|NCT00619619|Other Pre-specified|Change From Baseline in Hamilton Rating Scale for Depression 17-item (HAMD-D17) Total Score|HAM-D, clinician-rated interview, measures presence of depressive symptoms in 17 areas (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, & weight loss). Total score ranges from 0 to 52; higher scores reflect higher severity of current illness states.|Baseline, Inpatient Days 1 to 4, Outpatient Days 5 to 7, Outpatient Weeks 2 through 8 and Outpatient Week >8 (or early termination)|ITT||Score on a scale||Standard Deviation|Mean
758870|NCT00619619|Other Pre-specified|Change From Baseline in Children's Depression Ratings Scale-Revised (CDRS-R) Total Score|CDRS-R total score: scale measures 17 depressive symptoms, of which 3 are rated 1 to 5 and 14 are rated 1 to 7 (1 = no symptom difficulties; 5 or 7 = severe clinically significant difficulties) for a total score range of 17 to 113. Lower total scores indicate lower intensity of symptoms.|Baseline, Inpatient Days 1 to 4, Outpatient Days 5 to 7, Outpatient Weeks 2 through 8 and Outpatient Week >8 (or early termination)|ITT: all treatment-assigned subjects with a baseline primary efficacy evaluation, at least 1 dose of study treatment, and at least 1 primary efficacy evaluation after the first dose of study treatment.||scores on a scale||Standard Deviation|Mean
758871|NCT00619645|Secondary|Number of Patients Alive 24 Months Post Day 100 Transplant|Patients will be followed for survival for 24 months post day 100 transplant.|24 months post day 100 transplant|||Participants|||Count of Participants
758872|NCT00619645|Secondary|Number of Patients Without Progression After Day 100 Transplant|All patients will be followed for progression for 24 months after their day 100 transplant.|24 months after day 100 transplant|This outcome was not collected/analyzed|||||
760309|NCT00634569|Primary|Serious Bacterial Infections.|Total number of Bacterial pneumonia, bacteremia or sepsis, osteomyelitis/septic arthritis, visceral abscess or bacterial meningitis|12 months|||Total serious bacterial infections|||Number
758880|NCT00619762|Primary|Histology Sample Evaluations Assessing Incorporation of StratticeTM Reconstructive Tissue Matrix|Evaluation of 3 histology parameters, fibroblast infiltration, immune cell response & revascularization, expressed as frequency distributions. Samples evaluated for presence of fibroblasts (cellularity), neovascularization & immune cell response using 4 pt scale. Fibroblast Infiltration: 1=None,2=Few,sparse,3=Moderate,4=Dense. Revascularization:1=None,2=Few randomly dispersed capillaries,3=Moderate; mostly homogenous distribution of new vessels,4=Significant,uniformly distributed vessels; both capillaries and arterioles. Immune Cell response: 1= None,2=Few,normal healing response,3=Moderate,4=Significant;above expected presence for healing. 4 high power(HP)fields reviewed & if uniform in appearance/cellular distribution, 4 considered representative of sample as a whole. If non-uniform distribution observed, 3 HP fields of “sparse or light” distribution & 3 HP fields of dense distribution counted & results averaged. Tissue sample then assessed for overall acellularity & expressed as %.|At the time of expander/implant exchange (Stage II),|All implanted patients enrolled in the study were included in the analysis||percentage of breasts|Participants||Number
758881|NCT00619762|Secondary|Severity of Local Inflammation at and Around the Surgical Site|The Inflammatory response was evaluated by each of the four cardinal signs: erythema, edema, pain and heat, using standard scales for the evaluation of each sign and inflammation as a whole was assessed using a model (AIR Score) which took into account the scores assigned to each of the four signs. A mean score is provided at each timepoint.The minimum total possible score is 4 (less inflamation) and the maximum total possible score is 8 (more inflammation).|Postoperative Day 7, 14, 21, 30 days|Total breasts enrolled were 29. Day 7, N = 28 breasts available Day 14, N = 27 breasts available Day 21, N = 27 breasts available Day 30, N = 25 breasts available||units on a scale|Participants|Standard Deviation|Mean
758882|NCT00619801|Secondary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Creatinine||Baseline, 14 days|Safety Population; only non-missing values were analyzed||micromole per liter [µmol/L]||Full Range|Median
758883|NCT00619801|Secondary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Urea Nitrogen||Baseline, 14 days|Safety Population; only non-missing values were analyzed||millimole per liter [mmol/L]||Full Range|Median
758884|NCT00619801|Secondary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Aspartate Aminotransferase (AST)||Baseline, 14 days|Safety Population; only non-missing values were analyzed||unit per liter [U/L]||Full Range|Median
758885|NCT00619801|Secondary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Alanine Aminotransferase (ALT)||Baseline, 14 days|Safety Population; only non-missing values were analyzed||unit per liter [U/L]||Full Range|Median
758886|NCT00619801|Secondary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Total Bilirubin||Baseline, 14 days|Safety Population; only non-missing values were analyzed||micromole per liter [µmol/L]||Full Range|Median
758887|NCT00619801|Primary|Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia’s Formula (QTcF) at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV)|The QT interval refers to the respective time interval in the Electrocardiogram (ECG).|14 days|Safety Population; only non-missing values were analyzed||milliseconds||Standard Deviation|Mean
758888|NCT00619801|Primary|Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia’s Formula (QTcF) at Visit 3 (Day 7)|The QT interval refers to the respective time interval in the Electrocardiogram (ECG).|7 days|Safety Population; only non-missing values were analyzed||milliseconds||Standard Deviation|Mean
758889|NCT00619801|Primary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval Corrected for Heart Rate Using Fridericia’s Formula (QTcF)|The QT interval refers to the respective time interval in the Electrocardiogram (ECG).|Baseline, 14 days|Safety Population; only non-missing values were analyzed||milliseconds||Standard Deviation|Mean
758890|NCT00619801|Primary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval|The QT interval refers to the respective time interval in the Electrocardiogram (ECG).|Baseline, 14 days|Safety Population; only non-missing values were analyzed||milliseconds||Standard Deviation|Mean
758891|NCT00619801|Primary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QRS Duration|The QRS duration refers to the respective time duration in the Electrocardiogram (ECG).|Baseline, 14 days|Safety Population; only non-missing values were analyzed||milliseconds||Standard Deviation|Mean
758892|NCT00619801|Primary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in PR Interval|The PR interval refers to the respective time interval in the Electrocardiogram (ECG).|Baseline, 14 days|Safety Population; only non-missing values were analyzed||milliseconds||Standard Deviation|Mean
758893|NCT00619801|Primary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in RR Interval|The RR interval refers to the respective time interval in the Electrocardiogram (ECG).|Baseline, 14 days|Safety Population; only non-missing values were analyzed||milliseconds||Standard Deviation|Mean
758894|NCT00619801|Primary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Ventricular Rate (VR)||Baseline, 14 days|Safety Population; only non-missing values were analyzed||beats per minute||Standard Deviation|Mean
758895|NCT00619827|Primary|Average of Rhinoconjunctivitis Total Symptom Score (ARTSS) ]0-4] Hours|The primary efficacy variable was the Average of Rhinoconjunctivitis Total Symptom Score (ARTSS) during the four-hour (]0-4] hours) grass pollen allergen challenge at end point (after four months of treatment) of the 6 rhinoconjunctivitis symptoms (sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes). The severity of each symptom was evaluated by the subject, before allergen exposure and every 15 minutes during allergen challenge on a scale of 0 to 3; 0: no symptoms, 1: mild symptoms, 2: moderate symptoms, 3: severe symptoms, total score range was 0 to 18. The ARTSS ]0-4] hours was calculated as the mean of the RTSSs at each timepoint during the allergen challenge (i.e., 16 timepoints from 15 minutes to 4 hours) after 4 months of treatment (endpoint). The lower the score, the better the outcome.|4 months|The Intent-to-treat (ITT) population included all randomised subjects who received at least one dose of the investigational product.||Units on a scale (range: 0 to 18)||Standard Error|Mean
758926|NCT00619957|Secondary|Percent Change From Baseline in Femoral Trochanter BMD, Month 24, ITT Population.|DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis.|Baseline to Month 24|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
758896|NCT00619892|Secondary|Change in Scores in Measurements of Depressive Symptoms (Hamilton Depression Rating Scale, HAM-D), Generalized Anxiety Symptoms (Hamilton Anxiety Rating Scale, HAM-A) and the Sleep Quality Item of the Pittsburgh Sleep Quality Index (PSQI).|Subjects scores on secondary efficacy measures were measured, comparing baseline and the end of 8 weeks of treatment, including the Hamilton Depression Rating Scale, HAM-D, which has 21 items, with scores ranging from 0-66; the Hamilton Anxiety Rating Scale, HAM‑A, which has 14 items, with scores ranging from 0-56; and the sleep quality item of the PSQI, a four-point scale rating sleep quality as very good, fairly good, fairly bad or very bad.|Comparing baseline and the end of 8 weeks of treatment|||units on a scale||Standard Deviation|Mean
758897|NCT00619892|Primary|Change in Mean Total Panic Disorder Severity Scale (PDSS) Scores|Possible total scores on the PDSS range from 0-28. The outcome measure represents the change, between baseline and the end of 8 weeks of treatment, in the the total PDSS scores. Lower scores indicate less severe panic disorder symptoms. A negative mean change in the scores at the end of 8 weeks represents a decrease in severity of panic disorder symptoms.|Baseline and the end of 8 weeks of treatment|||units on a scale||Standard Deviation|Mean
758898|NCT00619918|Secondary|Supplemental Medication Use||14 days||||||
758899|NCT00619918|Secondary|IV Fluid Use||14 days||||||
758900|NCT00619918|Secondary|Hours of Oxygen Use||14 days||||||
758901|NCT00619918|Primary|Change in RDAI Score||1 day||||||
758902|NCT00619918|Primary|Length of Stay|Length of stay defined as date of discharge minute date of admission.|1 month|||Days||Standard Deviation|Mean
758903|NCT00619918|Primary|Admission Rate|Patients enrolled in the ED who required inpatient admission. Patients who required admission but were transferred to another facility due to lack of available beds were considered admitted for this outcome. Note, neither study site has an observation unit.|1 day|||participants|||Number
758904|NCT00619957|Secondary|Cumulative Incidence of Fractures, 24 Months, ITT Population|Kaplan-Meier Cumulative Incidence, fractures / 100 patients / 2 years|Baseline to Month 24|ITT Population||Fractures / 100 patients / 2 years|||Number
758905|NCT00619957|Secondary|Cumulative Incidence of Fractures, 12 Months, ITT Population|Kaplan-Meier Cumulative Incidence, fractures / 100 patients / year|Baseline to Month 12|ITT Population||Fractures / 100 patients / year|||Number
758906|NCT00619957|Secondary|Percent of Responders Lumbar Spine BMD, Month 24, ITT Population|responder = positive change (>0) in lumbar spine BMD from Baseline to Month 24|Baseline to Month 24|ITT Population||Percentage of Participants|||Number
758907|NCT00619957|Secondary|Change From Baseline in Body Height, 24 Months/Endpoint, ITT Population.||Baseline to 24 Months/Endpoint|ITT Population, LOCF (Last Observation Carried Forward)||millimeters||95% Confidence Interval|Least Squares Mean
758908|NCT00619957|Secondary|Change From Baseline in Body Height, Month 24, ITT Population.||Baseline to Month 24|ITT Population||millimeters||95% Confidence Interval|Least Squares Mean
758909|NCT00619957|Secondary|Change From Baseline in Body Height, Month 12, ITT Population.||Baseline to Month 12|ITT Population||millimeters||95% Confidence Interval|Least Squares Mean
758910|NCT00619957|Secondary|Percent Change From Baseline in BAP, 24 Months/Endpoint, ITT Population.||Baseline to 24 Months/Endpoint|ITT Population, LOCF (Last Observation Carried Forward)||Percent Change||95% Confidence Interval|Least Squares Mean
758911|NCT00619957|Secondary|Percent Change From Baseline in BAP, Month 24, ITT Population.||Baseline to Month 24|ITT Population||percent||95% Confidence Interval|Least Squares Mean
758912|NCT00619957|Secondary|Percent Change From Baseline in BAP, Month 12, ITT Population.||Baseline to Month 12|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
758913|NCT00619957|Secondary|Percent Change From Baseline in BAP, Month 6, ITT Population.||Baseline to Month 6|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
758914|NCT00619957|Secondary|Percent Change From Baseline in BAP (Bone-specific Alkaline Phosphatase), Month 3, ITT Population.||Baseline to Month 3|ITT Population||percent||95% Confidence Interval|Least Squares Mean
758915|NCT00619957|Secondary|Percent Change From Baseline in NTx/Cr, 24 Months/Endpoint, ITT Population.||Baseline to 24 Months/Endpoint|ITT Population, LOCF (Last Observation Carried Forward)||Percent Change||95% Confidence Interval|Least Squares Mean
758916|NCT00619957|Secondary|Percent Change From Baseline in NTx/Cr, Month 24, ITT Population.||Baseline to Month 24|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
758917|NCT00619957|Secondary|Percent Change From Baseline in NTx/Cr, Month 12, ITT Population.||Baseline to Month 12|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
758918|NCT00619957|Secondary|Percent Change From Baseline in NTx/Cr, Month 6, ITT Population.||Baseline to Month 6|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
758919|NCT00619957|Secondary|Percent Change From Baseline in NTx/Cr (Type I Collagen N-telopeptide/Creatinine), Month 3, ITT Population.||Baseline to Month 3|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
758920|NCT00619957|Secondary|Percent Change From Baseline in CTx, 24 Months/Endpoint, ITT Population.||Baseline to 24 Months/Endpoint|ITT Population, LOCF (Last Observation Carried Forward)||Percent Change||95% Confidence Interval|Least Squares Mean
758921|NCT00619957|Secondary|Percent Change From Baseline in CTx, Month 24, ITT Population.||Baseline to Month 24|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
758922|NCT00619957|Secondary|Percent Change From Baseline in CTx, Month 12, ITT Population.||Baseline to Month 12|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
758923|NCT00619957|Secondary|Percent Change From Baseline in CTx, Month 6, ITT Population.||Baseline to Month 6|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
758924|NCT00619957|Secondary|Percent Change From Baseline in CTx (Type I Collagen C-telopeptide), Month 3, ITT Population.||Baseline to Month 3|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
758925|NCT00619957|Secondary|Percent Change From Baseline in Femoral Trochanter BMD, 24 Months/Endpoint, ITT Population.|DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis.|Baseline to 24 Months/Endpoint|ITT Population, LOCF (Last Observation Carried Forward)||Percent Change||95% Confidence Interval|Least Squares Mean
758928|NCT00619957|Secondary|Percent Change From Baseline in Femoral Trochanter BMD, Month 6, ITT Population.|DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis.|Baseline to Month 6|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
758929|NCT00619957|Secondary|Percent Change From Baseline in Femoral Neck BMD, 24 Months/Endpoint, ITT Population.|DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Mean of 2 scans performed will be utilized. Baseline femoral neck values measured on Lunar instruments will be normalized to Hologic reference. Hologic reference BMD = (0.836 x BMD[lunar]) - 0.008|Baseline to 24 Months/Endpoint|ITT Population, LOCF (Last Observation Carried Forward)||Percent Change||95% Confidence Interval|Least Squares Mean
758930|NCT00619957|Secondary|Percent Change From Baseline in Femoral Neck BMD, Month 24, ITT Population.|DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Mean of 2 scans performed will be utilized. Baseline femoral neck values measured on Lunar instruments will be normalized to Hologic reference. Hologic reference BMD = (0.836 x BMD[lunar]) - 0.008|Baseline to Month 24|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
758931|NCT00619957|Secondary|Percent Change From Baseline in Femoral Neck BMD, Month 12, ITT Population.|DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Baseline femoral neck values measured on Lunar instruments will be normalized to Hologic reference. Hologic reference BMD = (0.836 x BMD[lunar]) - 0.008|Baseline to Month 12|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
758932|NCT00619957|Secondary|Percent Change From Baseline in Femoral Neck BMD, Month 6, ITT Population.|DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Baseline femoral neck values measured on Lunar instruments will be normalized to Hologic reference. Hologic Reference BMD = (0.836 x BMD[lunar]) - 0.008|Baseline to Month 6|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
758933|NCT00619957|Secondary|Percent Change From Baseline in Total Proximal Femur BMD, 24 Months/Endpoint, ITT Population.|DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Mean of 2 scans performed will be utilized. Results standardized (sBMD): Hologic sBMD = 1000 x (1.008 x BMD + 0.006), Lunar sBMD = 1000 x (0.979 x BMD - 0.031).|Baseline to 24 Months/Endpoint|ITT Population, LOCF (Last Observation Carried Forward)||Percent Change||95% Confidence Interval|Least Squares Mean
758934|NCT00619957|Secondary|Percent Change From Baseline in Total Proximal Femur BMD, Month 24, ITT Population.|DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Mean of 2 scans performed will be utilized. Results standardized (sBMD): Hologic sBMD = 1000 x (1.008 x BMD + 0.006), Lunar sBMD = 1000 x (0.979 x BMD - 0.031).|Baseline to Month 24|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
758935|NCT00619957|Secondary|Percent Change From Baseline in Total Proximal Femur BMD, Month 12, ITT Population.|DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading. Results standardized (sBMD): Hologic sBMD = 1000 x (1.008 x BMD + 0.006), Lunar sBMD = 1000 x (0.979 x BMD - 0.031).|Baseline to Month 12|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
758936|NCT00619957|Secondary|Percent Change From Baseline in Total Proximal Femur BMD, Month 6, ITT Population.|DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading. Results standardized (sBMD): Hologic sBMD = 1000 x (1.008 x BMD + 0.006), Lunar sBMD = 1000 x (0.979 x BMD - 0.031).|Baseline to Month 6|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
758937|NCT00619957|Secondary|Percent Change From Baseline in Lumbar Spine BMD, Month 24, ITT Population.|DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading. Mean of 2 scans performed. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522).|Baseline to Month 24|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
758938|NCT00619957|Secondary|Percent Change From Baseline in Lumbar Spine BMD, Month 12, ITT Population.|DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522).|Baseline to Month 12|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
758939|NCT00619957|Secondary|Percent Change From Baseline in Lumbar Spine BMD, Month 6, ITT Population.|DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading.DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522).|Baseline to Month 6|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
758940|NCT00619957|Primary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), 24 Months/Endpoint, ITT Population.|DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Site will perform at screening to determine if scan should be forwarded to central facility for analysis. Mean of 2 scans performed read by central lab to determine entry qualification. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522).|Baseline to 24 Months/Endpoint|ITT Population, LOCF (Last Observation Carried Forward)||Percent Change||95% Confidence Interval|Least Squares Mean
758941|NCT00619970|Primary|Number of Participants With SIBO at Baseline (Week 0) and at 2 Week Post Treatment||baseline (week 0) and at 2 weeks post treatment|1 patient from the treatment group withdrew from the study. Four additional children, 2 from the treatment group and 2 from the placebo group, did not show up for their follow up breath test||Participants|||Count of Participants
758942|NCT00619970|Primary|The Number of Participants at Baseline With SIBO||upon enrollment|||Participants|||Count of Participants
758973|NCT00620282|Secondary|Haematology and Biochemistry Tests - Number of Subjects With Creatinine Values Outside Reference Range|Number of subjects with serum creatinine values outside reference range at Week 0 and Week 12, respectively. Reference range: Female (lower value 0.600 mg/dL, upper value 1.100 mg/dL) Male (lower value 0.800 mg/dL, upper value 1.300 mg/dL).|week 0, week 12|Safety population included all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.||participants|||Number
758944|NCT00620022|Secondary|Inspiratory Capacity (IC) Assessed at Rest With Spirometry at the End of Each Treatment Period 60 Minutes Pre-dose|At the end of each 3 week treatment period 60 minutes before inhalation of study drug, IC was measured with spirometry conducted according to internationally accepted standards. The mean of 3 acceptable measurements was calculated and reported in liters.|End of each 3 week treatment period (last day of Weeks 3 and 9)|Modified-intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug. The number of patients analyzed for each treatment group was the number with non-missing values for the dependent and independent variables in the mixed model.||Liters||Standard Error|Least Squares Mean
758945|NCT00620022|Primary|Exercise Duration Time Assessed by Constant-load Cycle Ergometry at the End of Each Treatment Period|At the end of each 3 week treatment period, patients completed constant-load cycle ergometry testing at a work-rate of 75% of the Wmax determined at Screening. This work-rate was maintained until symptom limitation caused the patient to stop exercising. The time from the start of loaded pedaling until the patient stopped exercising was recorded.|End of each 3 week treatment period (last day of Weeks 3 and 9)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug. The number of patients analyzed for each treatment group was the number with non-missing values for the dependent and independent variables in the mixed model.||Seconds||Standard Error|Least Squares Mean
758946|NCT00620035|Primary|Implant Removal Time (Seconds)|The implant removal time was the time expressed in seconds, from making the removal incision until placing the butterfly closure. Data was presented for overall investigators including experienced and non-experienced.|Day 1|All-Subjects-Treated (AST) group included all participants who had the Radiopaque implant inserted (N=301). Data was reported for 292 implant removals.||Seconds||Standard Deviation|Mean
758947|NCT00620035|Primary|Implant Insertion Time (Seconds)|The implant insertion time was the time expressed in seconds, from removal of the protection cap from the applicator until retraction of the needle from the arm after insertion. Data was presented for overall investigators including experienced and non-experienced.|Day 1|All-Subjects-Treated (AST) group included all participants who had the Radiopaque implant inserted (N=301). Data was reported for 291 implant insertions.||Seconds||Standard Deviation|Mean
758948|NCT00620035|Primary|Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Applicator Satisfaction|In order to evaluate efficacy and ease of use of the NGA, the investigator/AU completed a User Satisfaction Questionnaire on Day 1 after the 12th implant insertion. The domain, 'Applicator Satisfaction' consisted of one question in order to assess the applicator. The percentage of AUs who were very satisfied and satisfied was presented.|Day 1|The Applicator User (AU) group consisted of all investigators participating in the trial and who performed at least one insertion.||Percentage of Applicator Users|||Number
758949|NCT00620035|Primary|Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Used Time|In order to evaluate efficacy and ease of use of the NGA, the investigator/AU completed a User Satisfaction Questionnaire on Day 1 after the 12th implant insertion. The domain, 'Used Time' consisted of one question: insertion time was assessed. The percentage of AUs who were very satisfied and satisfied was presented.|Day 1|The Applicator User (AU) group consisted of all investigators participating in the trial and who performed at least one insertion.||Percentage of Applicator Users|||Number
758950|NCT00620035|Primary|Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire by Domain: Safety|In order to evaluate efficacy and ease of use of the NGA, the investigator/AU completed a User Satisfaction Questionnaire on Day 1 after the 12th implant insertion. The domain, 'Safety' consisted of three questions: removal of the protection cap from applicator, full retraction of the needle into the applicator after insertion, difference in colors of the obturator & the implant. The percentage of AUs who were very satisfied and satisfied was presented.|Day 1|The Applicator User (AU) group consisted of all investigators participating in the trial and who performed at least one insertion.||Percentage of Applicator Users|||Number
758951|NCT00620035|Primary|Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Functionality|In order to evaluate efficacy and ease of use of the NGA, the investigator/AU completed a User Satisfaction Questionnaire on Day 1 after the 12th implant insertion. The domain, 'Functionality' consisted of six questions assessing functionality of the needle. The percentage of AUs who were very satisfied and satisfied was presented.|Day 1|The Applicator User (AU) group consisted of all investigators participating in the trial and who performed at least one insertion.||Percentage of Applicator Users|||Number
758952|NCT00620035|Primary|Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Design & Technical Aspects|In order to evaluate efficacy and ease of use of the Next Generation Applicator (NGA), the investigator/applicator user (AU) completed a User Satisfaction Questionnaire on Day 1 after the 12th implant insertion. The domain, 'Design/technical aspects' consisted of five questions: fit of the applicator in the hand, size, weight, handling, and color of the applicator were assessed. The percentage of AUs who were very satisfied and satisfied was presented.|Day 1|The Applicator User (AU) group consisted of all investigators participating in the trial and who performed at least one insertion.||Percentage of Applicator Users|||Number
758953|NCT00620074|Secondary|Voriconazole Trough Levels With Intravenous and Oral Dosing|Voriconazole trough plasma concentrations measured as nanograms per milliliter (ng/mL).|Week 1 through Week 6|ITT; only 1 pharmacokinetic sample was collected for each subject, therefore a comprehensive analysis of trough plasma concentrations was not completed due to insufficient data.||ng/mL||Standard Deviation|Mean
760360|NCT00625820|Secondary|Systolic Blood Pressure Measured at 6 and 12 Weeks of Therapy.||12 weeks|||mmHG||Standard Deviation|Mean
758954|NCT00620074|Secondary|Galactomannan Titer Assay Levels and Global Response|Number of subjects per Galactomannan titer level with global response for all subjects (with or without renal impairment). The galactomann assay is an immunological blood serum test used to diagnose invasive aspergillosis and to monitor disease progression. Global response is a composite of clinical and radiological findings summarized as Complete Response: resolution of all clinical signs and symptoms; Partial Response: clinical improvement; Stable Response: no change from baseline or an improvement of less than 50% in radiological findings; Failure (no response): worsening disease.|Up to Week 6|ITT. No descriptive or inferential analysis was completed due to low enrollment and subsequent early termination of study.||participants|||Number
758955|NCT00620074|Secondary|Summary of Mortality|Number of subects with documented mortality (death).|Up to Week 6|ITT||participants|||Number
758956|NCT00620074|Secondary|Summary of Global Response at Week 2, Week 4, and Week 6|Number of subjects with global response consisting of a combination of clinical and radiological findings at the end of therapy. Possible outcome categories: Complete Response: resolution of all clinical signs and symptoms and more than 90% of lesions due to invasive aspergillosis that were visible on radiological studies; Partial Response: clinical improvement and greater than 50% improvement in radiological findings; Stable Response: no change from baseline or an improvement of less than 50% in radiological findings; Failure (no response): worsening disease.|Week 2, Week 4, Week 6|ITT; due to low study enrollment, data not summarized by global response at Week 2, Week 4, and Week 6. Cross-reference outcome measure: Summary of Global Response at End of Treatment (EOT).||participants|||Number
758957|NCT00620074|Primary|Summary of Global Response at End of Treatment (EOT)|Number of subjects with global response consisting of a combination of clinical and radiological findings at the end of therapy. Possible outcome categories: Complete Response: resolution of all clinical signs and symptoms and more than 90% of lesions due to invasive aspergillosis that were visible on radiological studies; Partial Response: clinical improvement and greater than 50% improvement in radiological findings; Stable Response: no change from baseline or an improvement of less than 50% in radiological findings; Failure (no response): worsening disease.|End of Treatment (Day 42)|Intent-to-treat (ITT): includes all subjects who received at least 1 dose of study medication. No descriptive or inferential analysis was completed due to low enrollment and subsequent early termination of study.||participants|||Number
758958|NCT00620113|Secondary|Percent Change From Baseline to Week 52 in Serum N-Terminal Propeptides of Type 1 Collagen (s-P1NP) Level|s-P1NP is a biochemical marker index of bone formation. Blood samples were collected in the morning and in fasting state for measurement of s- P1NP. Percent change from baseline in biomarker = ([biomarker value at Week 52 visit] – [baseline biomarker value] ÷ baseline biomarker value) × 100. All measurements of bone biochemical markers were centrally performed.|Baseline (Wk 0), Week 52|PP Population: All randomized participants receiving at least one dose of study medication, who complied with the protocol (excludes participants with major protocol violation), and with available s-P1NP data.||percent change||95% Confidence Interval|Least Squares Mean
758959|NCT00620113|Secondary|Percent Change From Baseline to Week 52 in Serum Bone Specific Alkaline Phosphatase (s-BSAP) Level|s-BSAP is a biochemical marker index of bone formation. Blood samples were collected in the morning and in fasting state for measurement of s-BSAP. Percent change from baseline in biomarker = ([biomarker value at Week 52 visit] – [baseline biomarker value] ÷ baseline biomarker value) × 100. All measurements of bone biochemical markers were centrally performed.|Baseline (Wk 0), Week 52|PP Population: All randomized participants receiving at least one dose of study medication, who complied with the protocol (excludes participants with major protocol violation), and with available s-BSAP data.||percent change||95% Confidence Interval|Least Squares Mean
758960|NCT00620113|Secondary|Percent Change From Baseline to Week 52 in Urinary Deoxypyridinoline/Creatinine Ratio (u-DPD/Cre)|The u-DPD/Cre ratio is a biochemical marker index of bone resorption. Urine samples were collected from second void morning urine specimens to assess the u-DPD/Cre ratio. Percent change from baseline in biomarker = ([biomarker value at Week 52 visit] – [baseline biomarker value] ÷ baseline biomarker value) × 100. All measurements of bone biochemical markers were centrally performed.|Baseline (Wk 0), Week 52|PP Population: All randomized participants receiving at least one dose of study medication, who complied with the protocol (excludes participants with major protocol violation), and with available u-DPD/Cre data.||percent change||95% Confidence Interval|Least Squares Mean
758961|NCT00620113|Secondary|Percent Change From Baseline to Week 52 in Serum C-Telopeptides of Type 1 Collagen (s-CTx) Level|s-CTx is a biochemical marker index of bone resorption. Blood samples were collected in the morning and in fasting state for measurement of s-CTx. Percent change from baseline in biomarker = ([biomarker value at Week 52 visit] – [baseline biomarker value] ÷ baseline biomarker value) × 100. All measurements of bone biochemical markers were centrally performed.|Baseline (Wk 0), Week 52|PP Population: All randomized participants receiving at least one dose of study medication, who complied with the protocol (excludes participants with major protocol violation), and with available s-CTx data.||percent change||95% Confidence Interval|Least Squares Mean
758962|NCT00620113|Secondary|Percent Change From Baseline to Week 52 in Urinary N-telopeptides/Creatinine (u-NTx/Cre) Ratio|The u-NTx/Cre ratio is a biochemical marker index of bone resorption. Urine samples were collected from second void morning urine specimens to assess the u-NTx/Cre ratio. Percent change from baseline in biomarker = ([biomarker value at Week 52 visit] – [baseline biomarker value] ÷ baseline biomarker value) × 100. All measurements of bone biochemical markers were centrally performed.|Baseline (Wk 0), Week 52|Per Protocol (PP) Population: All randomized participants receiving at least one dose of study medication, who complied with the protocol (excludes participants with major protocol violation), and with available u-NTx/Cre data.||percent change||95% Confidence Interval|Least Squares Mean
758972|NCT00620282|Secondary|Number of Hypoglycaemic Episodes|Total number of hypoglycaemic episodes occurring from week 0 to week 12. Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself and either plasma glucose was below 56 mg/dL or symptoms were reversed after food intake or glucagon/intravenous glucose administration. Minor if subject was able to treat her/himself and plasma glucose was below 56 mg/dL. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 56 mg/dL.|weeks 0-12|Safety population included all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.||episodes|||Number
758963|NCT00620113|Secondary|Percent Change From Baseline to Week 52 in Trochanter BMD|BMD (g/cm2) data was measured by DXA at the trochanter subregion of the hip (near bony protrusions along outside edge of femur) at the Observation visit (up to 5 weeks before Treatment Period), Week 0 (start of Treatment Period) and Week 52 (end of Treatment Period) or at discontinuation. Baseline was defined as the average of the 2 values collected at the Observation visit and Week 0 visit. Percent change from baseline in BMD = ([BMD at Week 52 visit] – [baseline BMD] ÷ baseline BMD) × 100. Measurements were performed using the Hologic QDR Series densitometer, and by same machine and under same scan mode throughout the study period. BMD data was centrally judged.|Baseline (Observation visit to Wk 0 treatment visit), Week 52|FAS: All randomized participants receiving at least one dose of study medication and with necessary on-treatment trochanter BMD measurements, with data carried forward.||percent change||95% Confidence Interval|Least Squares Mean
758964|NCT00620113|Secondary|Percent Change From Baseline to Week 52 in Femoral Neck BMD|BMD (g/cm2) data was measured by DXA at the femoral neck subregion of the hip at the Observation visit (up to 5 weeks before Treatment Period), Week 0 (start of Treatment Period) and Week 52 (end of Treatment Period) or at discontinuation. Baseline was defined as the average of the 2 values collected at the Observation visit and Week 0 visit. Percent change from baseline in BMD = ([BMD at Week 52 visit] – [baseline BMD] ÷ baseline BMD) × 100. Measurements were performed using the Hologic QDR Series densitometer, and by same machine and under same scan mode throughout the study period. BMD data was centrally judged.|Baseline (Observation visit to Wk 0 treatment visit), Week 52|FAS: All randomized participants receiving at least one dose of study medication and with necessary on-treatment femoral neck BMD measurements, with data carried forward.||percent change||95% Confidence Interval|Least Squares Mean
758965|NCT00620113|Primary|Number of Participants That Discontinued Study Drug Due to an AE|An AE was defined as any unfavorable and unintended change in the structure (sign), function (symptoms), or chemistry of the body (laboratory data) temporally associated with the use of the SPONSOR’s products (including placebo), whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR’s product was also an AE. The number of participants that discontinued study drug due to an AE was reported for each treatment arm. Participants may have discontinued study drug but continued on the trial.|From first dose up to end of treatment (up to 52 weeks)|Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.||participants|||Number
758966|NCT00620113|Primary|Number of Participants That Experienced an Adverse Event (AE)|An AE was defined as any unfavorable and unintended change in the structure (sign), function (symptoms), or chemistry of the body (laboratory data) temporally associated with the use of the SPONSOR’s products (including placebo), whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR’s product was also an AE. The number of participants that experienced at least one AE was reported for each treatment arm.|From first dose up to Post-Study (up to 54 weeks)|Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.||participants|||Number
758967|NCT00620113|Secondary|Percent Change From Baseline to Week 52 in Total Hip BMD|BMD (g/cm2) data was measured by DXA for total hip at the Observation visit (up to 5 weeks before Treatment Period), Week 0 (start of Treatment Period) and Week 52 (end of Treatment Period) or at discontinuation. Baseline was defined as the average of the 2 values collected at the Observation visit and Week 0 visit. Percent change from baseline in BMD = ([BMD at Week 52 visit] – [baseline BMD] ÷ baseline BMD) × 100. Measurements were performed using the Hologic QDR Series densitometer, and by same machine and under same scan mode throughout the study period. BMD data was centrally judged.|Baseline (Observation visit to Wk 0 treatment visit), Week 52|FAS: All randomized participants receiving at least one dose of study medication and with necessary on-treatment total hip BMD measurements, with data carried forward.||percent change||95% Confidence Interval|Least Squares Mean
758968|NCT00620113|Primary|Percent Change From Baseline to Week 52 in Lumbar Spine Bone Mineral Density (BMD) at Lumbar Vertebrae 1 to 4 (L1-L4)|BMD (g/cm2) data was measured by dual-energy X-ray absorptiometry (DXA) at lumbar spine vertebrae 1 through 4 (L1-L4) from anterior view at the Observation visit (up to 5 weeks before Treatment Period), Week 0 (start of Treatment Period) and Week 52 (end of Treatment Period) or at discontinuation. Baseline was defined as the average of the 2 values collected at the Observation visit and Week 0 visit. Percent change from baseline in BMD = ([BMD at Week 52 visit] – [baseline BMD] ÷ baseline BMD) × 100. Measurements were performed using the Hologic Quantitative Digital Radiography (QDR) Series densitometer, and by same machine and under same scan mode throughout the study period. BMD data was centrally judged.|Baseline (Observation visit to Wk 0 treatment visit), Week 52|Full Analysis Set (FAS): All randomized participants receiving at least one dose of study medication and with necessary on-treatment lumbar spine BMD measurements, with data carried forward.||percent change||95% Confidence Interval|Least Squares Mean
758969|NCT00620126|Primary|Percentage of Participants Adherent to Therapy|Adherence was assessed using the Morisky Medication Adherence Score, a 4 item survey in which participants self-report medication-taking behavior. Each question that is answered with a No receives a score of 1. The possible scoring range is therefore 0 to 4. Higher scores correlate with better medical adherence. For the purpose of evaluating percent of participants adherent to therapy, the variable was dichotomized to “Adherent” or “Non-adherent”. Any response of Yes to one of the 4 items was scored as “Non-Adherent”.|12 Months|||Percentage of Participants|||Number
758970|NCT00620126|Primary|Quality of Life (IBDQ)|Disease-specific quality of life was assessed using the IBD questionnaire (IBDQ). Scores for the IBDQ range from 32 to 224 with higher scores being associated with better quality of life. Score changes of 16 have been found to be significant changes when compared to baseline values.|12 Months|||Units||Standard Deviation|Mean
758971|NCT00620126|Primary|Clinical Disease Activity (Seo Index)|Clinical disease activity was assessed using the Seo index. An activity index <120 represents clinical remission, whereas scores of 121-150, 151-220, and >221 correlate with mild, moderate, and severe disease respectively. The Seo index is sensitive to change, with a decrease in the index of 35 correlating with a clinical response.|12 months|||Units||Standard Deviation|Mean
758974|NCT00620282|Secondary|Haematology and Biochemistry Tests - Number of Subjects With Blood Urea Nitrogen (BUN) Values Outside Reference Range|Number of subjects with serum BUN values outside reference range at Week 0 and Week 12, respectively. Reference range: Female (lower value 6.000 mg/dL, upper value 21.000 mg/dL) Male (lower value 8.000 mg/dL, upper value 25.000 mg/dL).|week 0, week 12|Safety population included all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.||participants|||Number
758975|NCT00620282|Secondary|Biomarkers of Cardiovascular Risk - Change in TNF-alpha|Change in TNF-alpha|week 0, week 12|The ANCOVA full analysis set (FAS) includes all randomised subjects for whom data points could be collected at end of trial.||pg/mL||Standard Error|Least Squares Mean
758976|NCT00620282|Secondary|Fasting Lipid Profile - Change in Triglycerides (TG)|Change in TG|week 0, week 12|The ANCOVA full analysis set (FAS) includes all randomised subjects for whom data points could be collected at end of trial.||mg/dL||Standard Error|Least Squares Mean
758977|NCT00620282|Secondary|Fasting Lipid Profile - Change in HDL-C|Change in HDL-C|week 0, week 12|The ANCOVA full analysis set (FAS) includes all randomised subjects for whom data points could be collected at end of trial.||mg/dL||Standard Error|Least Squares Mean
758978|NCT00620282|Secondary|Fasting Lipid Profile - Change in LDL-C|Change in LDL-C|week 0, week 12|The ANCOVA full analysis set (FAS) includes all randomised subjects for whom data points could be collected at end of trial.||mg/dL||Standard Error|Least Squares Mean
758979|NCT00620282|Secondary|Fasting Lipid Profile - Change in Total Cholesterol (TC)|Change in TC|week 0, week 12|The ANCOVA full analysis set (FAS) includes all randomised subjects for whom data points could be collected at end of trial.||mg/dL||Standard Error|Least Squares Mean
758980|NCT00620282|Secondary|Change in Body Weight||week 0, week 12|The ANCOVA full analysis set (FAS) includes all randomised subjects for whom data points could be collected at end of trial.||kg||Standard Error|Least Squares Mean
758981|NCT00620282|Secondary|Change in Mean Postprandial Glucose (PPG) Based on Self-measured 7-point Plasma Glucose Profiles|The 7-point profile included plasma glucose measurements at the following time points: before each main meal (breakfast, lunch and dinner), 90 minutes after the start of each main meal (breakfast, lunch and dinner) and at bedtime.|week 0, week 12|The ANCOVA full analysis set (FAS) includes all randomised subjects for whom data points could be collected at end of trial.||mg/dL||Standard Error|Least Squares Mean
758982|NCT00620282|Secondary|Change in Fasting Plasma Glucose (FPG)|Change in FPG|week 0, week 12|The ANCOVA full analysis set (FAS) includes all randomised subjects for whom data points could be collected at end of trial.||mg/dL||Standard Error|Least Squares Mean
758983|NCT00620282|Secondary|Change in HbA1c (Glycosylated Haemoglobin A1c)|Percentage point change in HbA1c|week 0, week 12|The ANCOVA full analysis set (FAS) includes all randomised subjects for whom data points could be collected at end of trial.||percentage of total haemoglobin||Standard Error|Least Squares Mean
758984|NCT00620282|Secondary|Change in Sodium Nitroprusside (SNP)-Mediated Forearm Blood Flow (FBF)|Assessed endothelial function by measuring the change in SNP-mediated FBF at euglycemia (90 mg/dL) using forearm venous occlusion plethysmography (VOP) technique. Unit of Measure refers to volume of blood (mL) per 100 mL of forearm tissue per minute.|week 0, week 12|The ANCOVA full analysis set (FAS) includes all randomised subjects for whom data points could be collected at end of trial.||mL/100 mL/min||Standard Error|Least Squares Mean
758985|NCT00620282|Primary|Change in Acetylcholine (ACh)-Mediated Forearm Blood Flow (FBF)|Assessed endothelial function by measuring the change in ACh-mediated FBF at euglycemia (90 mg/dL) using forearm venous occlusion plethysmography (VOP) technique. Unit of Measure refers to volume of blood (mL) per 100 mL of forearm tissue per minute.|week 0, week 12|The ANCOVA full analysis set (FAS) includes all randomised subjects for whom data points could be collected at end of trial.||mL/100 mL/min||Standard Error|Least Squares Mean
758986|NCT00620373|Secondary|Recall Rate|Recall rate was defined as the percentage of participants recalled for follow-up studies initiated because of abnormal findings with mammography or gamma imaging.|12 months after mammography and gamma imaging|The analysis population only included participants with a verified cancer status at 12 months after the initial screening (mammography and gamma imaging).||percentage of participants||95% Confidence Interval|Number
758987|NCT00620373|Secondary|Specificity|Specificity measures the proportion of negatives which are correctly identified as such.|12 month after mammography and gamma imaging|The analysis population only included participants with a verified cancer status at 12 months after the initial screening (mammography and gamma imaging). The number of participants negative for breast cancer was 936-11 = 925.||number of true negatives|||Number
758988|NCT00620373|Primary|Number of Participants With Cancer Diagnosis at 12 Months||12 months after mammography and gamma imaging|The analysis population only included participants with a verified cancer status at 12 months after the initial screening (mammography and gamma imaging).||participants|||Number
758989|NCT00620373|Secondary|Sensitivity|Sensitivity measures the proportion of actual positives which are correctly identified as such.|12 months after mammography and gamma imaging|The analysis population only included participants with a verified cancer status at 12 months after the initial screening (mammography and gamma imaging).||number of cancers diagnosed|||Number
758990|NCT00620373|Primary|Diagnostic Yield|Diagnostic yield is the likelihood that a test or procedure will provide the information needed to establish a diagnosis. In this case, it is the proportion of women with positive results of a screening test and positive results with the reference standard (verified cancer status).|12 months after mammography and gamma imaging|The analysis population only included participants with a verified cancer status at 12 months after the initial screening (mammography and gamma imaging).||cancers per 1000 women screened||95% Confidence Interval|Number
758991|NCT00620425|Primary|The Number of Injections With Local Site Reactions (Bleeding, Swelling, Bruising and Erythema).|Each of the 18 participants were injected three times (for a total of 54 injections)with Sumavel DosePro, and followed over three days.|-15 min, immediately Post-dose, and 1, 4, 8, 24, 48 and 72 hrs post-dose|||injections|Participants||Number
759053|NCT00614055|Secondary|Physical Examination|Physical examination is performed at baseline (Week 0) and after 8 and 16 weeks of treatment. If any new findings or deterioration in previous findings were observed during the trial, these were recorded as AEs and are therefore not presented separately as no analysis was performed.|Week 0, Week 8, Week 16||||||
772070|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 4|Subject Satisfaction - ease of inflation|6 months post-surgery|||% satisfactory or somewhat satisfactory|||Number
758992|NCT00620464|Primary|Bioequivalence of Implanon® and Radiopaque Implanon|"Bioequivalence testing was performed based on serum etonogestrel Cmax. Bioequivalence was to be concluded when the 90% confidence limits of Cmax were fully contained within the acceptance range of 0.80-1.25.
Cmax (pg/mL): Peak concentration."|3 years|All-Subjects-Pharmacokinetically-Evaluable consisted of 103 subjects.Subjects excluded from PK evaluation due to age, use of by protocol prohibited steroidal medication during trial and contraceptives within one week prior to Implanon insertion and their pre-insertion ENG concentration was not proven to be below Lower Limit Of Quantification (LLOQ)||pg/mL||Full Range|Mean
758993|NCT00620464|Primary|Bioequivalence of Implanon® and Radiopaque Implanon.|"Bioequivalence testing was performed based on serum etonogestrel AUC0-6months, AUC0-24months, and AUC0-36months. Bioequivalence was to be concluded when the 90% confidence limits of AUC0-6months, AUC0-24months, and AUC0-36months were fully contained within the acceptance range of 0.80-1.25.
AUC0-6months (Area under the curve from zero to six months).
AUC0-24months (Area under the curve from zero to 24 months).
AUC0-36months (Area under the curve from zero to 36 months)."|3 years|103 subjects were pharmacokinetically evaluable. Subjects were excluded from PK evaluation for use of protocol-prohibited steroidal medication during the trial or contraceptives within 1 week prior to Implanon insertion, or because their pre-insertion ENG concentration was not proven to be below the Lower Limit of Quantification (LLOQ)||pg•month/mL||Full Range|Mean
758994|NCT00620542|Secondary|VLDL-C During the 104 Week Treatment Period|Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.|104 weeks|Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).||mg/dL||Standard Error|Least Squares Mean
758995|NCT00620542|Secondary|Apoliprotein B/Apolipoprotein A-1 Blood Level|Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.|104 weeks|Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).||Ratio||Standard Error|Least Squares Mean
758996|NCT00620542|Secondary|Apolipoprotein A-1 Blood Level|Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.|104 weeks|Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).||mg/dL||Standard Error|Least Squares Mean
758997|NCT00620542|Secondary|Apolipoprotein B Blood Level|Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.|104 weeks|Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).||mg/dL||Standard Error|Least Squares Mean
758998|NCT00620542|Secondary|Non-HDL-C/HDL-C Blood Level|Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.|104 weeks|Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).||Ratio||Standard Error|Least Squares Mean
758999|NCT00620542|Secondary|Total Cholesterol/HDL-C Blood Level|Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.|104 weeks|Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).||Ratio||Standard Error|Least Squares Mean
759000|NCT00620542|Secondary|LDL-C/HDL-C Blood Level|Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.|104 weeks|Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).||Ratio||Standard Error|Least Squares Mean
759001|NCT00620542|Secondary|Non-HDL-C Blood Level|Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.|104 weeks|Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).||mg/dL||Standard Error|Least Squares Mean
759002|NCT00620542|Secondary|Triglycerides Blood Level|Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.|104 weeks|Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).||mg/dL||Standard Error|Least Squares Mean
759003|NCT00620542|Secondary|HDL-C Blood Level|Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.|104 weeks|Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).||mg/dL||Standard Error|Least Squares Mean
759004|NCT00620542|Secondary|LDL-C Blood Level|Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.|104 weeks|Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).||mg/dL||Standard Error|Least Squares Mean
759005|NCT00620542|Secondary|Total Cholesterol Blood Level|Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.|104 weeks|Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).||mg/dL||Standard Error|Least Squares Mean
759006|NCT00620542|Secondary|Numbers of Patients Showing Regression in TAV|Regression defined as a change from baseline in TAV < 0|End of study (Week 104)|Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).||Participants|||Number
759054|NCT00614055|Secondary|Vital Signs: Pulse|Values at baseline (Week 0) and at Week 16|Week 0, Week 16|The SAS included all subjects who received at least one dose of the investigational product or its comparator.||beats/minute||Standard Deviation|Mean
759007|NCT00620542|Secondary|Change From Baseline to End of Study (Week 104) in Total Atheroma Volume (TAV)|Change in TAV, as measured by IVUS, computed as TAV(Week 104)-TAV(baseline) where TAV is the sum(EEMcsa-LUMENcsa)/n. n is the number of cross-sections measured. TAV for each patient is calculated as the average area of atheroma per cross-section multiplied by the median number of cross-sections measured for all patients in the analysis population.|End of study (Week 104)|Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).||mm^3||95% Confidence Interval|Median
759008|NCT00620542|Secondary|Numbers of Patients Showing Regression in PAV|Regression defined as a change from baseline in PAV < 0|End of study (Week 104)|Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).||Participants|||Number
759009|NCT00620542|Primary|Change From Baseline to End of Study (Week 104) in Percent Atheroma Volume (PAV)|"Change in PAV computed as PAV(Week 104)-PAV(baseline) where PAV is calculated as:
[sum(EEMcsa-LUMENcsa)/sum EEMcsa]*100 where EEMcsa is the cross-sectional area of the external elastic membrane and LUMENcsa is the cross-sectional area of the lumen, as measured by intravascular ultrasound IVUS of a coronary artery in patients with CAD."|End of study (Week 104)|Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).||Percent change||95% Confidence Interval|Median
759010|NCT00620555|Secondary|Percent Change in Seizure Frequency|Percent change in seizure frequency (PCH) was calculated as follows: PCH = 100*(T minus B) divided by B, where T is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 52-week treatment period, and B is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 6-week baseline period of the previous study A9451162 (NCT00603473).|Up to 52 weeks|"Intent to treat (ITT): Subjects who have received at least one dose of the study drug and in whom the number of epileptic seizures used for efficacy assessment has been counted in both the baseline and treatment periods.
n = number of participants who have total number of seizures at each assessment time point."||Percent change||Full Range|Median
759011|NCT00620555|Secondary|Responder Rate|Responder Rate was defined as the percentage of subjects with a 50 percent or greater reduction in the seizure frequency per 28 days for the 52-week treatment period in comparison with the frequency per 28 days for the 6-week baseline period of the previous study A9451162 (NCT00603473).|Up to 52 weeks|"Intent to treat (ITT): Subjects who have received at least one dose of the study drug and in whom the number of epileptic seizures used for efficacy assessment has been counted in both the baseline and treatment periods.
n = number of participants who have total number of seizures at each assessment time point."||Percentage of participants||95% Confidence Interval|Number
759012|NCT00620555|Secondary|Response Ratio|The Response Ratio calculated by the following equation : Response Ratio = (T minus B) divided by (T plus B), where T is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 52-week treatment period, and B is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 6-week baseline period of the previous study A9451162 (NCT00603473).|Up to 52 weeks|"Intent to treat (ITT): Subjects who have received at least one dose of the study drug and in whom the number of epileptic seizures used for efficacy assessment has been counted in both the baseline and treatment periods.
n = number of participants who have total number of seizures at each assessment time point."||Ratio||Standard Deviation|Mean
759013|NCT00620555|Primary|Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-Related)|Any untoward medical occurrence in a participant who received study drug was considered an adverse event (AE), without regard to possibility of causal relationship. Treatment-emergent adverse events: those which occurred or worsened after baseline. Severe AEs: those which interferes significantly with participant's usual function. An AE resulting in any of the following outcomes, was considered to be a serious adverse event: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect.|up to 53 weeks|Safety analysis set: All paticipants who have received at least one dose of the study drug.||Participants|||Number
759014|NCT00620659|Secondary|Epworth Sleepiness Scale (ESS) Score for the Mode Dose of MK0249 Versus Placebo|"The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire that provides subjective reports that equate with sleep propensity, not with 'subjective sleepiness'. Having a high sleep propensity means having a history of dozing in situations that have a relatively low soporific nature, in which normal subjects seldom doze. The ESS consists of eight items, which are rated from 0 (would never dose) to 3 (high chance of dozing). The ESS score is the total score of the 8 individual items; this total score ranges from 0 to 24 (higher total score is worse)."|At Week 2|Full Analysis Set (FAS): The FAS population was a subset of all randomized patients with patients excluded for failure to receive at least one dose of study treatment or lack of an endpoint data. Patients with at least one dose and endpoint in at least one treatment period were included in the FAS.||units on a scale||Standard Error|Least Squares Mean
759015|NCT00620659|Secondary|Clinical Global Impressions Scale of Severity Score as it Relates to Excessive Daytime Sleepiness (CGIS-EDS) for the Mode Dose of MK0249 Versus Placebo|Clinical Global Impressions Scale of Severity (CGI-S) is a subscale of the CGI which is a standard psychometric scale used to demonstrate changes and improvements in illness. CGI-S consists of a 7-point scale rated from 1 to 7. The investigator or sponsor-approved clinician judged how ill the patient was with respect to Excessive Daytime Sleepiness (EDS) at the time of the CGI-S rating (CGIS-EDS), with higher scores indicating more severe illness.|At Week 2|Full Analysis Set (FAS): The FAS population was a subset of all randomized patients with patients excluded for failure to receive at least one dose of study treatment or lack of an endpoint data. Patients with at least one dose and endpoint in at least one treatment period were included in the FAS.||units on a scale||Standard Error|Least Squares Mean
759055|NCT00614055|Secondary|Vital Signs: Systolic Blood Pressure (BP)|Values at baseline (Week 0) and at Week 16|Week 0, Week 16|The SAS included all subjects who received at least one dose of the investigational product or its comparator.||mmHg||Standard Deviation|Mean
759056|NCT00614055|Secondary|Vital Signs: Diastolic Blood Pressure (BP)|Values at baseline (Week 0) and at Week 16|Week 0, Week 16|The SAS included all subjects who received at least one dose of the investigational product or its comparator.||mmHg||Standard Deviation|Mean
762503|NCT00653159|Secondary|Heavy Bleeding Rates|Rates of participants experiencing heavy bleeding among teens randomized to the LNG-IUS or Copper T 380A.|6 months|All study participants were included in the analysis.||percentage of randomized subjects|||Number
759016|NCT00620659|Secondary|Mean of Average Maintenance of Wakefulness Test Early for Top 2 Doses Pooled of MK0249 Versus Modafinil|The Maintenance of Wakefulness Test (MWT) is an objective assessment of sleepiness that measures the ability of a patient to remain awake. The primary endpoint was the mean of sleep latency (average of the first 4 MWTs which were at 0900, 1100, 1300, and 1500), where latency for each MWT was defined as the time to onset of the first 16 continuous seconds of any stage of sleep; if no sleep was observed according to these rules, then latency was defined as 30 minutes. The comparison was for the top 2 doses pooled of MK0249 versus modafinil.|At Week 2|Full Analysis Set (FAS): The FAS population was a subset of all randomized patients with patients excluded for failure to receive at least one dose of study treatment or lack of an endpoint data. Patients with at least one dose and endpoint in at least one treatment period were included in the FAS.||Minutes||Standard Error|Least Squares Mean
759017|NCT00620659|Secondary|Mean of Average Maintenance of Wakefulness Test Early for the Mode Dose of MK0249 Versus Modafinil|The Maintenance of Wakefulness Test (MWT) is an objective assessment of sleepiness that measures the ability of a patient to remain awake. The primary endpoint was the mean of sleep latency (average of the first 4 MWTs which were at 0900, 1100, 1300, and 1500), where latency for each MWT was defined as the time to onset of the first 16 continuous seconds of any stage of sleep; if no sleep was observed according to these rules, then latency was defined as 30 minutes. The comparison was for the mode dose of MK0249 versus modafinil.|At Week 2|Full Analysis Set (FAS): The FAS population was a subset of all randomized patients with patients excluded for failure to receive at least one dose of study treatment or lack of an endpoint data. Patients with at least one dose and endpoint in at least one treatment period were included in the FAS.||Minutes||Standard Error|Least Squares Mean
759018|NCT00620659|Primary|Mean of Average Maintenance of Wakefulness Test Early for The Mode Dose of MK0249 Versus Placebo|The Maintenance of Wakefulness Test (MWT) is an objective assessment of sleepiness that measures the ability of a patient to remain awake. The primary endpoint was the mean of sleep latency (average of the first 4 MWTs which were at 0900, 1100, 1300, and 1500), where latency for each MWT was defined as the time to onset of the first 16 continuous seconds of any stage of sleep; if no sleep was observed according to these rules, then latency was defined as 30 minutes. The comparison was for the mode dose of MK0249 versus placebo.|At Week 2|Full Analysis Set (FAS): The FAS population was a subset of all randomized patients with patients excluded for failure to receive at least one dose of study treatment or lack of endpoint data. Patients with at least one dose and endpoint in at least one treatment period were included in the FAS.||Minutes||Standard Error|Least Squares Mean
759019|NCT00620698|Secondary|Handheld Dynamometry|The main outcome measure was the coefficient of variation (CoV) in the rate of the decline for each measure over time. The CoV was calculated by dividing the standard deviation in the rate of decline across the group of subjects and dividing that by the mean rate of decline for the cohort. This approach was taken for each of the measures being evaluated (ALS Functional Rating Scale-Revised, Handheld dynamometry, Electrical impedance myography). The lower the CoV in the rate of decline, the more sensitive it is to identifying a potential treatment effect, since it suggests gives a measure of homogeneity of the rate of decline across the population as well as the overall rate of decline. The smaller the standard deviation across the group and the larger the mean rate of decline across the group, the lower the CoV and the fewer number of subjects needed for a potential clinical trial using that outcome measure.|6 months|||Coefficient of variation||95% Confidence Interval|Mean
759020|NCT00620698|Secondary|ALS Functional Rating Scale|The main outcome measure was the coefficient of variation (CoV) in the rate of the decline for each measure over time. The CoV was calculated by dividing the standard deviation in the rate of decline across the group of subjects and dividing that by the mean rate of decline for the cohort. This approach was taken for each of the measures being evaluated (ALS Functional Rating Scale-Revised, Handheld dynamometry, Electrical impedance myography). The lower the CoV in the rate of decline, the more sensitive it is to identifying a potential treatment effect, since it suggests gives a measure of homogeneity of the rate of decline across the population as well as the overall rate of decline. The smaller the standard deviation across the group and the larger the mean rate of decline across the group, the lower the CoV and the fewer number of subjects needed for a potential clinical trial using that outcome measure.|6 months|||Coefficient of variation||95% Confidence Interval|Mean
759021|NCT00620698|Primary|Electrical Impedance Myography|The main outcome measure was the coefficient of variation (CoV) in the rate of the decline for each measure over time. The CoV was calculated by dividing the standard deviation in the rate of decline across the group of subjects and dividing that by the mean rate of decline for the cohort. This approach was taken for each of the measures being evaluated (ALS Functional Rating Scale-Revised, Handheld dynamometry, Electrical impedance myography). The lower the CoV in the rate of decline, the more sensitive it is to identifying a potential treatment effect, since it suggests gives a measure of homogeneity of the rate of decline across the population as well as the overall rate of decline. The smaller the standard deviation across the group and the larger the mean rate of decline across the group, the lower the CoV and the fewer number of subjects needed for a potential clinical trial using that outcome measure.|6 months|||Coefficient of Variation||95% Confidence Interval|Mean
759022|NCT00620711|Primary|Cap Cooled to 12 Degrees Without Reducing Rectal Temperature|Yes/no|6 hours|||participants|||Number
759023|NCT00620711|Primary|Feasibility Trial- the Olympic Cool Cap Will be Applied, Can the Delivered Cap Temperature be Less Than 12 Degrees Without Changing Rectal Temperature.|Measurement of number of participants able to obtain 12 degree cap temperature|60 minutes intervals|all analysized||participants|||Number
759024|NCT00620750|Primary|Percent of Patients Initiating Vivitrol Treatment Who Receive 3 Consecutive Monthly Vivitrol Injections||4 months|Per protocol||Percent of participants|||Number
759025|NCT00620763|Primary|Calcium Absorption|After 3 weeks equilibration to the diet, the 2-day menu was extrinsically labeled with Calcium-47 radiotracer and retention was monitored for 28 days by whole body scintillation counting. Percent Calcium-47 absorbed was estimated from the y-intercept of the linear portion of a semilogarithmic plot of percent Calcium-47 retained vs time.|18 weeks|Analysis included only the 16 volunteers that completed both dietary interventions.||percentage of Calcium-47 absorbed||Standard Error|Mean
759057|NCT00614055|Secondary|Laboratory Safety Parameters (Biochemistry): Serum Creatinine|Values at screening (Week -4) and at Week 16|Week -4, Week 16|The SAS included all subjects who received at least one dose of the investigational product or its comparator.||umol/L||Standard Deviation|Mean
759026|NCT00620776|Secondary|50 Percent or Greater Reduction in PSWQ Score|Clinically significant change was defined on the PSWQ as an estimated (based on linear mixed effects model) endpoint score of less than 50.9. This score was calculated using the PSWQ normative data provided by Gillis, Haaga, and Ford (1995) and the baseline PSWQ mean and standard deviation (SD) from the current sample. The PSWQ mean and SD from the normative and current GAD samples were entered into the Jacobson et al. (1984) formula “c” for clinically significant change. This method provides a cutoff indicating whether or not the level of functioning by a patient is statistically more likely to be in the functional rather than the dysfunctional population.|Data collected as part of protocol 709012 at baseline, week 12, and week 24|||Participants|||Count of Participants
759027|NCT00620776|Secondary|Clinical Response Rate|Clinical response on the HAM-A was defined as a 50% or greater reduction from baseline to last value with the 24-week open label medication phase.|Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24|||Participants|||Count of Participants
759028|NCT00620776|Secondary|Mental Component Score of the 12-item Short Form Survey (SF-12)|The Short Form (12) Health Survey is a 12-item, patient-reported survey of patient health. Physical and Mental Health Component Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.|Data collected as part of protocol 709012 at baseline, week 12, and week 24|Number analyzed at different time points varies due to patient dropout.||units on a scale||Standard Deviation|Mean
759029|NCT00620776|Secondary|Physical Component Score of the 12-Item Short Form Survey (SF-12)|The Short Form (12) Health Survey is a 12-item, patient-reported survey of patient health. Physical and Mental Health Component Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.|Data collected as part of protocol 709012 at baseline, week 12, and week 24|Number analyzed at different time points varies due to patient dropout.||units on a scale||Standard Deviation|Mean
759030|NCT00620776|Secondary|Penn State Worry Questionnaire (PSWQ)|The Penn State Worry Questionaire is a 16-item inventory that aims to measure the trait of worry, using Likert rating from 1 (not at all typical of me) to 5 (very typical of me). A total score is calculated (range = 16 to 80), with higher scores indicating greater worry.|Data collected as part of protocol 709012 at baseline, week 12, and week 24|Number analyzed at different time points varies due to patient dropout.||units on a scale||Standard Deviation|Mean
759031|NCT00620776|Secondary|Quality of Life Subscale of the General Health Questionnaire (GHQ)|The General Health Questionnaire (GHQ) is a psychometric screening tool to identify common psychiatric conditions. Patients completed the 12 quality of life questions (each on a 0 to 3 scale) on this questionnaire. Scores on the 12 items were added up to create summary score (range = 0 to 36). Higher scores indicate worse health.|Data collected as part of protocol 709012 at baseline, week 12, and week 24|Number analyzed at different time points varies due to patient dropout.||units on a scale||Standard Deviation|Mean
759032|NCT00620776|Secondary|Clinical Global Impression (CGI)-Improvement Score|The Clinical Global Impression – Improvement scale (CGI-I) is a 7 point scale (1= very much improved; 7 = very much worse) that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. The ratings were conducted by research psychiatrists trained and highly experienced in the use of these scales. Evaluators were blind to group assignment.|Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24|Number analyzed at different time points varies due to patient dropout.||units on a scale||Standard Deviation|Mean
759033|NCT00620776|Secondary|Clinical Global Impression (CGI)-Severity Score|The Clinical Global Impression – Severity scale (CGI-S) is a 7-point scale (1=normal; 7 = extremely ill) that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. The ratings were conducted by research psychiatrists trained and highly experienced in the use of these scales. Evaluators were blind to group assignment.|Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24|Number analyzed at each time point differs due to patient dropout.||units on a scale||Standard Deviation|Mean
759034|NCT00620776|Secondary|Hamilton Rating Scale for Depression (HAM-D)-17-item Score|The 17-item version of the HAM-D was used to assess severity of depressive symptoms. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2.The total score is the sum of the 17 items, with a range from 0 to 50. A higher scores indicates greater depression. The ratings were conducted by research psychiatrists trained and highly experienced in the use of these scales. The evaluators were blind to group assignment.|Data collected as part of protocol 709012 at baseline, week 12, and week 24|Numbers analyzed at various time points differ due to patient dropout.||units on a scale||Standard Deviation|Mean
759035|NCT00620776|Secondary|Hospital Anxiety Depression Scale (HAD)-Depression Score|The HAD was used to assess patients’ report of anxiety and depressive symptoms. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. A higher score indicates greater depression.|Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24|Numbers analyzed at various time points differ due to patient dropout.||units on a scale||Standard Deviation|Mean
759036|NCT00620776|Secondary|Hospital Anxiety Depression Scale (HAD)-Anxiety Score|The HAD was used to assess patients’ report of anxiety and depressive symptoms. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. A higher score indicates greater anxiety.|Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24|Numbers analyzed at various time points differ due to patient dropout.||units on a scale||Standard Deviation|Mean
759037|NCT00620776|Primary|Hamilton Anxiety Rating Scale (HAM-A)|The HAM-A was used to measure the severity of anxiety symptoms. The scale consists of 14 items; each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0–56, where <17 indicates mild severity, 18–24 mild to moderate and 25–30 moderate to severe anxiety. This measure was conducted by research psychiatrists trained and highly experienced in the use of these scales. The evaluators were blind to group assignment.|Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24|Number analyzed at various time points differ due to patient dropout.||units on a scale||Standard Deviation|Mean
759038|NCT00620815|Secondary|Mean T-Cells Per Million Total Cells (95% CI) in Response to H5 Peptides and H5N1 Subunit|"Frequency and functionality of vaccine antigen-specific CD4+ (cluster of differentiation 4) T cells was assessed in peripheral blood (PBMC) taken at days 1, 22 and 43 after in vitro stimulation with:
Library of 70 peptides spanning the whole H5 A/Vietnam/1194/2004 protein (H5 pool of 70 Vietnam) H5N1 subunit from A/Vietnam/1194/2004 (H5N1 Vietnam) H3N2 subunit from A/ Wisconsin/67/2005 (H3N2 Wisconsin) H1N1 subunit from A/Solomon Islands/3/2006 (H1N1 Solomon Islands) Polyclonal stimulus agonistic aCD3 mAb [monoclonal antibody (aCD3)].
The change in frequency of T-cells was measured."|Three weeks after 1st vaccination (day 22) and three weeks after 2nd vaccination (day 43)|Analysis was done on full analysis set||Mean cells per million total cells||95% Confidence Interval|Mean
759039|NCT00620815|Secondary|Percentages of B-cell Antibodies Against H5N1 and H1N1 After Each Vaccination.|"The Cell Mediated Immunity (CMI) response was evaluated in a randomly selected subgroup of approximately 92 subjects from all the vaccine groups out of a total of 601 enrolled subjects.
Frequency of circulating memory B cells (MBC), capable of differentiating in vitro into cell secreting IgG (Immunoglobulin G) antibodies specific for H5N1 (the subunit from A/Vietnam/1194/2004) or for H1N1 (the subunit from A/Solomon Island/3/2006) were determined by an ELISA-coupled limiting dilution assay.The frequency of H5N1-IgG MBC and H1N1-IgG MBC was expressed as percentages (%) of total IgG producing MBC."|Three weeks after first vaccination (day 22) and three weeks after second vaccination (day 43)|The analysis was done on Full analysis set||Percentages of B-cell antibodies||95% Confidence Interval|Mean
759040|NCT00620815|Secondary|Antibody Response Determined by HI and MN Assay.|Measurement of immunogenicity in terms of Geometric mean titers (GMTs) as determined by HI and MN assay.|Up to 43 days|The population was analyzed on Per protocol set||titers||95% Confidence Interval|Mean
759041|NCT00620815|Secondary|Percentages of Subjects Achieving HI/MN ≥ 1:40 and SRH Area ≥ 25^mm2|Measurement of immunogenicity in terms of percentage of subjects achieving a titre ≥ 40/area ≥ 25mm^2 after immunization as determined by HI (Haemagglutination Inhibition), MN(Microneutralization) and SRH assay.|Up to 43 days|The analysis was done on Per Protocol Set||Percentages of subjects||95% Confidence Interval|Number
759042|NCT00620815|Secondary|Percentages of Subjects Achieving Seroconversion/Significant Increase in Antibody Titre/ Area as Measured by SRH and (HI) and at Least 4 Fold Rise in Titres by Micro-neutralization (MN) Assay-H5N1 Strain|"Measurement of immunogenicity in terms of significant increase in antibody titer and Seroconversion.
Significant increase in antibody titer is defined as at least a four-fold increase from non-negative pre-vaccination serum (≥ 10) for HI or a 50% increase in area for SRH.
Seroconversion is defined as negative pre-vaccination serum / post-vaccination titer ≥40 for HI (area ≥25 mm2 for SRH)"|up to day 43|The population was analyzed on per protocol set.||Percentage of subjects||95% Confidence Interval|Number
759043|NCT00620815|Secondary|Number of Subjects (Subjects ≤ 60 Years) With Reported Systemic Reactions After 1st and 2nd Vaccinations.|Systemic reactions were collected upto 7 days after 1st and 2nd vaccinations. All subjects were instructed to complete a diary card to record systemic reactions starting on the day of vaccination (after 6 hours) and for each of the 6 days following each immunization.|7 days after 1st and 2nd vaccinations each|The analysis was performed on Per Protocol Safety Population||Participants|||Number
759044|NCT00620815|Secondary|Number of Subjects (Subjects ≤60 Years) With Reported Local Reactions After Second Vaccination|Local reactions were collected up to 7 days after 1st vaccinations. All subjects were instructed to complete a diary card to record local reactions starting on the day of vaccination (after 6 hours) and for each of the 6 days following each immunization.|Up to 7 days after 2nd vaccination|The analysis was performed on Safety Population||Participants|||Number
759045|NCT00620815|Secondary|Number of Subjects (Subjects ≤ 60 Years) With Reported Local Reactions After First Vaccination|Local reactions were collected up to 7 days after 1st vaccinations. All subjects were instructed to complete a diary card to record local reactions starting on the day of vaccination (after 6 hours) and for each of the 6 days following each immunization. The table represents local reactions after first vaccination in each arm differently.|Up to 7 days after 1st vaccination|The analysis was performed on Safety Population||Participants|||Number
759046|NCT00620815|Primary|To Demonstrate the Equivalence of Antibody Response Against A/H5N1 Strain Elicited by the Three Different Immunization Schedules on Day 43.|"The antibody response was determined by SRH assay. Geometric mean areas (GMAs) and geometric mean ratios (GMRs) in the SRH assay were used to demonstrate the equivalence.
The statistical analysis was done based on the GMRs."|up to day 43|The analysis was done on Per Protocol Set (PPS)||Area (mm^2)||95% Confidence Interval|Geometric Mean
759047|NCT00620828|Secondary|Postoperative Day 1 Physical Therapy Outcome - Straight Leg Raise|Straight Leg Raise (SLR): number of people that can perform a SLR at designated intervals|4 hours, 8 hours, 12 hours and 24 hours post-op|||participants|||Number
759048|NCT00620828|Secondary|Postoperative Day 1 Physical Therapy Outcome- Knee Extension and Flexion|Knee extension and knee flexion measured at 24-hours post-operatively for patient cohort|24 hours post-op|||degrees||Standard Deviation|Mean
759049|NCT00620828|Secondary|Postoperative Day 1 Physical Therapy Outcome - Ambulation Distance|Ambulation distance walked by participants 24-hours post-operatively|24 hours post-op|||Feet||Standard Deviation|Median
759050|NCT00620828|Secondary|Total Fentanyl Patient-Controlled Anesthesia (PCA) Narcotic Consumption|The PCA total dose at the 4-hour, 8-hour, 12-hour and 24-hour post-operative time points.|4 hours to 24 hours post-op|||micrograms||Standard Deviation|Mean
759051|NCT00620828|Primary|Numeric Pain Score|Participants were asked to rate their pain on a scale of 0 to 10 at all time intervals up to 24 hours post-injection. Scores were organized into the following categories: 3 or less (mild pain), 4 to 6 (moderate pain), 7 or higher (severe pain).|Post-anesthesia care unit (PACU), 4 hours, 8 hours, 12 hours and 24 hours post-injection|per protocol||units on a scale||Standard Deviation|Mean
759052|NCT00620854|Primary|Plasma C-terminal Telopeptide of Type I Collagen (CTx-1)(% Change From Baseline)|This study compared the exposure to recombinant salmon calcitonin (rsCT), as measured by a decrease in plasma C-terminal telopeptide of type I collagen (CTx-1), of single doses of rsCT tablets containing 150 µg and 200 µg rsCT, respectively, with Fortical® nasal spray.|0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours (Fortical): 0, 2, 3, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 10, 12, 24 hours rsCTA and rsCTB|Per protocol, only subjects who completed all 3 treatments were analyzed.||% Change in Baseline CTx-1||Standard Error|Mean
772071|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 4|Subject Satisfaction - ease of inflation|3 months post-surgery|||% satisfactory or somewhat satisfactory|||Number
759058|NCT00614055|Secondary|Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT)|Values at screening (Week -4) and at Week 16|Week -4, Week 16|The SAS included all subjects who received at least one dose of the investigational product or its comparator.||IU/L||Standard Deviation|Mean
759059|NCT00614055|Secondary|Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT)|Values at screening (Week -4) and at Week 16|Week -4, Week 16|The SAS included all subjects who received at least one dose of the investigational product or its comparator.||IU/L||Standard Deviation|Mean
759060|NCT00614055|Secondary|Rate of Nocturnal Major and Minor Hypoglycaemic Episodes|Rate of nocturnal Major and Minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Episodes were defined as nocturnal if the time of onset was between 23:00 (included) and 06:00 (excluded).|Week 0 to Week 16 + 5 days follow up|The FAS included all randomised subjects.||Episodes/100 years of patient exposure|||Number
759061|NCT00614055|Secondary|Rate of Major and Minor Hypoglycaemic Episodes|Rate of Major and Minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 16 + 5 days follow up|The FAS included all randomised subjects.||Episodes/100 years of patient exposure|||Number
759062|NCT00614055|Secondary|Rate of Treatment Emergent Adverse Events (AEs)|Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject’s daily activities. Moderate: marked symptoms, moderate interference with subject’s daily activities. Severe: considerable interference with subject’s daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.|Week 0 to Week 16 + 5 days follow up|Safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or its comparator.||Events/100 years of patient exposure|||Number
759063|NCT00614055|Secondary|Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)|Mean of SMPG after 16 weeks of treatment. Plasma glucose measured: before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, bedtime, at 4 am and before breakfast.|Week 16|The FAS included all randomised subjects and missing data was imputed using LOCF.||mmol/L||Standard Error|Mean
759064|NCT00614055|Secondary|Change in Fasting Plasma Glucose (FPG)|Change from baseline in FPG after 16 weeks of treatment|Week 0, Week 16|The FAS included all randomised subjects and missing data was imputed using LOCF.||mmol/L||Standard Deviation|Mean
759065|NCT00614055|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Change from baseline in HbA1c after 16 weeks of treatment|Week 0, Week 16|Full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF).||percentage of glycosylated haemoglobin||Standard Deviation|Mean
759066|NCT00614120|Secondary|Hypoglycaemic Episodes|Total number of hypoglycaemic episodes over 16 weeks of treatment occurring from baseline (week 0) to end of treatment (week 16). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|weeks 0-16|Safety Analysis Set is all randomised subjects who have been exposed to at least one dose of study products.||episodes|||Number
759067|NCT00614120|Secondary|Change in Fasting Lipid Profile, APO-B|Change in fasting lipid profiles based on apolipoprotein B (Apo-B) from baseline (week 0) to 16 weeks (end of treatment).|week 0, week 16|The Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.||g/L||Standard Deviation|Median
759068|NCT00614120|Secondary|Change in Fasting Lipid Profile|"Change in fasting lipid profiles from baseline (week 0) to 16 weeks (end of treatment). Fasting lipid profiles is based on:
Total Cholesterol (TC)
Low-density Lipoprotein-cholesterol (LDL-C)
Very Low-density Lipoprotein-cholesterol (VLDL-C)
High-density Lipoprotein-cholesterol (HDL-C)
Triglyceride (TG)
Free Fatty Acid (FFA)"|week 0, week 16|The Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.||mmol/L||Standard Deviation|Mean
759069|NCT00614120|Secondary|Change in Beta-cell Function|"Change in beta cell function from baseline (week 0) to 16 weeks (end of treatment). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B).
Beta-cell function: HOMA-B (%) = 20∙fasting insulin[uU/mL] divided by (FPG mmol/L]‑3.5)."|week 0, week 16|The Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.||percentage point (%point)||Standard Deviation|Mean
759070|NCT00614120|Secondary|7-point Self-measured Plasma Glucose Profiles|Summary of 7-Point Profiles of Self-Measured Plasma Glucose by Treatment, Week and Time. The 7 time points for self-measurements for all treatment groups were: Before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime, measured over 16 weeks of treatment (at week 0, 8, 12 and 16).|week 0, 8, 12 and 16|The Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.||mg/dl||Standard Deviation|Mean
759071|NCT00614120|Secondary|Change in Self-measured Fasting Plasma Glucose|Change in self-measured fasting plasma glucose from baseline (week 0) to 16 weeks (end of treatment). Self-measurement of plasma glucose was performed using a glucose meter and subjects were instructed to record self-measured plasma glucose values into a diary.|week 0, week 16|The Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.||mg/dL||Standard Deviation|Mean
759072|NCT00614120|Secondary|Change in Body Weight|Change in body weight from baseline (week 0) to 16 weeks (end of treatment)|week 0, week 16|The Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.||kg||Standard Deviation|Mean
759073|NCT00614120|Primary|Change in Glycosylated Haemoglobin A1c (HbA1c)|Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 16 weeks (end of treatment).|week 0, week 16|The Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.||percentage point of total HbA1c||Standard Deviation|Mean
759074|NCT00614198|Secondary|Changes to Appearance of Multiple Compounds in Urine Samples||Baseline - 8 months -12 months - 24 months||||||
759075|NCT00614198|Primary|Change in Diet Groups Scores on One of Several Measures Used Against Pre-defined Statistical Thresholds as Evidence of Improvement.|ADOS (Autism Diagnostic Observation Schedule): module 1 cutoff scores (communication+social): autism=12, autism spectrum (AS)=7; module 2 cutoffs: autism=12, AS=8; module 3 cutoffs: autism=10; AS=7. GARS (Gilliam Autism Rating Scale): <80 low probability of autism, 81-90 below average, 91-110 average, >110 above average probability of autism. VABS (Vineland Adaptive Behaviour Scale): <69 (low ability), 70-84 (moderate/low), 85-115 (adequate), 116-130 (moderate/high), >130 (high). ADHD-IV: 0=no problems indicated. >11 attention & >11 hyperactivity = ADHD diagnosis.|Baseline - 8 months - 12 months - 24 months|Per protocol analysis. Analysis was conducted on n=26 (Gluten- and casein-free dietary intervention) and n=29 (No gluten- and casein-free dietary intervention) at 12 months. Analysis was conducted on n=18 and n=17 at 24 months (both on gluten- and casein-free dietary intervention).||Units on a scale||Standard Error|Mean
759076|NCT00614315|Secondary|Number of Device/Procedure-related Adverse Events(Safety of Delivery)|Device/Procedure-related adverse events from the index procedure through 30 days post procedure|Index Procedure to 30 days|||Number of Device/Procedure events|||Number
759077|NCT00614315|Primary|Technical Success for Delivery|defined as deployment of the implant to the intended location, assessed at the time of the index procedure.|Measured at the time of implantation (Day 0)|||Percentage of successful implantations|||Number
759078|NCT00614380|Secondary|Trough DBP Control Pre- and Post- Uptitration|The number of patients with DBP control (DBP<90 mmHg). Last trough DBP measurement before uptitration to Telmisartan 80mg compared to first trough DBP taken after uptitration|At any point during open-label treatment|Patients from the full analysis set who up-titrated to the higher dose of telmisartan 80 mg and amlodipine 10 mg. Full analysis set defined as all patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose||Participants|||Number
759079|NCT00614380|Secondary|Additional Reduction in SBP by Use of Additional Antihypertensive Therapy|Difference in trough SBP from last visit before add-on therapy and last visit during 1235.7|At any point during open-label treatment|Patients from the full analysis set who took additional antihypertensive medication as defined by the investigator. Full analysis set defined as all patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose||mmHg||Standard Deviation|Mean
759080|NCT00614380|Secondary|Additional Reduction in DBP by Use of Additional Antihypertensive Therapy|Difference in trough DBP from last visit before add-on therapy and last visit during 1235.7|At any point during open-label treatment|Patients from the full analysis set who took additional antihypertensive medication as defined by the investigator. Full analysis set defined as all patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose||mmHg||Standard Deviation|Mean
759081|NCT00614380|Secondary|Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control|The number of patients with DBP control (DBP<90 mmHg). Last trough DBP measurement before taking additional antihypertensive compared to last trough DBP taken on treatment|At any point during open-label treatment|Patients from the full analysis set who took additional antihypertensive medication as defined by the investigator. Full analysis set defined as all patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose||Participants|||Number
759082|NCT00614380|Secondary|Time to First Additional Antihypertensive|Time from first intake of medication to first intake of an antihypertensive other than the study drug|At any point during open-label treatment|Patients from the full analysis set who took additional antihypertensive medication as defined by the investigator. Full analysis set defined as all patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose||Days||Standard Deviation|Mean
759083|NCT00614380|Secondary|Trough Blood Pressure (BP) Normality Classes|The number of patients who reach predefined BP categories|End of study (34 weeks or last value on treatment)|The full analysis set of patients. All patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose||Participants|||Number
759084|NCT00614380|Secondary|Trough Seated SBP Response|The number of patients who reach the target SBP of <140mmHg or had a reduction in SBP >= 15 mmHg|End of study (34 weeks or last value on treatment)|The full analysis set of patients. All patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose||Participants|||Number
759085|NCT00614380|Secondary|Trough Seated DBP Response|The number of patients who reach the target DBP of <90mmHg or had a reduction in DBP >= 10mmHg|End of study (34 weeks or last value on treatment)|The full analysis set of patients. All patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose||Participants|||Number
759086|NCT00614380|Secondary|Change in SBP From Last Available Trough in 1235.5 to Last Available Trough in 1235.7|The difference between the last available troughs represents the additional reduction in SBP in this study|End of study (34 weeks or last value on treatment)|All patients who took at least one dose of study medication, have a trough baseline measurement (Last value on treatment in 1235.5) and at least one on treatment BP measurement 20-30 hours post dose||mmHg||Standard Error|Least Squares Mean
759087|NCT00614380|Secondary|Change From Baseline in Trough Seated Systolic Blood Pressure|Change from baseline to the end of study in trough SBP. Baseline is defined as visit 3 of trial 1235.5.|End of study (34 weeks or last value on treatment)|Full Analysis Set (FAS) included patients who took at least one dose of study medication and have at least one on treatment BP measurement||mmHg||Standard Error|Least Squares Mean
759088|NCT00614380|Secondary|Change in DBP From Last Available Trough in 1235.5 to Last Available Trough in 1235.7|The difference between the last available troughs represents the additional reduction in DBP in this study|End of study (34 weeks or last value on treatment)|Full Analysis Set (FAS) included patients who took at least one dose of study medication and have at least one on treatment BP measurement||mmHg||Standard Error|Least Squares Mean
759089|NCT00614380|Secondary|Change From Baseline in Trough Seated Diastolic Blood Pressure|Change from baseline to the end of study in trough DBP. Baseline is defined as visit 3 of trial 1235.5.|End of study (34 weeks or last value on treatment)|All patients who took at least one dose of study medication, have a trough baseline measurement (Visit 3 1235.5) and at least one on treatment BP measurement 20-30 hours post dose||mmHg||Standard Error|Least Squares Mean
759090|NCT00614380|Secondary|Trough Seated Systolic Blood Pressure (SBP) Control|The number of patients who reach the target SBP of <140mmHg|End of study (34 weeks or last value on treatment)|The full analysis set of patients. All patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose||Participants|||Number
759091|NCT00614380|Primary|Trough Seated Diastolic Blood Pressure (DBP) Control|The number of patients who reach the target DBP of <90mmHg|End of study (34 weeks or last value on treatment)|The full analysis set of patients. All patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose||Participants|||Number
759092|NCT00614393|Secondary|Overall Response Rate (ORR) of Dalotuzumab in Combination With Cetuximab + Irinotecan Versus ORR of Cetuximab + Irinotecan Alone in Participants With Wild Type of Colorectal Cancer|ORR, using RECIST 1.0, was defined as the percentage of participants in the analysis population who had a confirmed Complete Response (CR; disappearance of all target lesions) or Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions) at any time during the study, based on central radiology review.|Every 6 weeks (Up to 32 months)|The ITT population consisted of all participants who had a wtKRAS tumor genotype. The efficacy analyses were planned for and only included participants from the DB portion of the study. Participants from the OL portion were excluded from the analyses. Participants were counted in the group to which they were randomized.||Percentage of Participants|||Number
759093|NCT00614393|Primary|Percentage of Participants Who Experience an AE of Infusion Site Reaction|The percentage of participants who experienced an AE of infusion site reaction is presented.|Up to 30 days after last dose of study drug (Up to 33 months)|The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.||Percentage of Participants|||Number
759094|NCT00614393|Primary|Percentage of Participants Who Discontinue Study Drug Due to an AE|An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. The percentage of participants who discontinued study drug due to an AE is presented.|Up to last dose of study drug (Up to 32 months)|The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.||Percentage of Participants|||Number
759095|NCT00614393|Primary|Percentage of Participants Who Have a Drug-related Clinical or Laboratory CTCAE Grade 3 to 5 Toxicity|An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. (Grade 3=Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4=Life-threatening consequences; urgent intervention indicated. Grade 5=Death related to AE.) Drug-related AEs were those AEs that were possibly, probably, or definitely related to study drug or protocol-specified procedures. Participants were monitored for AEs related to dalotuzumab or placebo until the earlier of study discontinuation or 30 days after dalotuzumab/placebo discontinuation. AE grades were assessed using the NCI CTCAE, version 3.0.|Up to 30 days after last dose of study drug (Up to 33 months)|The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.||Percentage of Participants|||Number
759096|NCT00614393|Primary|Percentage of Participants Who Have a Clinical or Laboratory Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 to 5 Toxicity|An adverse event (AE) was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. (Grade 3=Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4=Life-threatening consequences; urgent intervention indicated. Grade 5=Death related to AE.) Participants were monitored for AEs until the earlier of study discontinuation or 30 days after dalotuzumab/placebo discontinuation. AE grades were assessed using the National Cancer Institute (NCI) CTCAE, version 3.0.|Up to 30 days after last dose of study drug (Up to 33 months)|The All Participants as Treated (APaT) population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.||Percentage of Participants|||Number
759097|NCT00614393|Primary|Progression-free Survival (PFS)|The PFS of participants with metastatic CRC expressing the wtKRAS genotype was defined as the time from the first day of study treatment to the first documented disease progression per Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST 1.0) as documented by an independent core laboratory, or death due to any cause, whichever occurred first. Disease progression was defined as either a 20% or greater relative increase in the sum of diameters of target lesions OR an absolute increase of at least 5mm in the sum of lesions or the appearance of new lesions. PFS was analyzed using the Kaplan-Meier method and is reported in months.|Up to last dose of study drug (Up to 32 months)|The ITT population consisted of all participants who had a wtKRAS tumor genotype. The efficacy analyses were planned for and only included participants from the DB portion of the study. Participants from the OL portion were excluded from the analyses. Participants were counted in the group to which they were randomized.||Months||Full Range|Median
759110|NCT00614523|Secondary|Annualized Rate of Total Platelet Transfusion Units|The time from first dose of study drug to the last dose of 26-week test treatment period. A unit of platelets is defined as a single pack of pooled platelet-rich plasma comprised of 6 to 8 individual platelet concentrate packs (200 to 400 mL), a single pack of pooled buffy-coat concentrate, or 1 apheresis (single donor) concentrate. Exposure adjusted event rate per 100 patient-years = events / patient-years * 100.|Test Treatment Period (Weeks 1-26)|Full analysis set includes all randomized subjects||units per 100 patient-years||95% Confidence Interval|Mean
759098|NCT00614393|Primary|Overall Survival (OS)|The OS of participants with metastatic colorectal cancer (CRC) expressing the KRAS wild-type (wtKRAS) tumor genotype (indicating no detection of KRAS mutation) was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. OS was analyzed using the Kaplan-Meier method and is reported in months.|Up to 12 weeks after last dose of study drug (Up to 35 months)|The Intent-to-Treat (ITT) population consisted of all participants who had a wtKRAS tumor genotype. The efficacy analyses were planned for and only included participants from the DB portion of the study. Participants from the OL portion were excluded from the analyses. Participants were counted in the group to which they were randomized.||Months||Full Range|Median
759099|NCT00614406|Primary|Menstrual Cycle Length|Menstrual cycle length was measured by the number of days subjects noted menstruating in their diary entry.|3 months|Intention to Treat (ITT)||Days||Standard Deviation|Mean
759100|NCT00614445|Primary|Diclectin Versus Placebo for Treatment of Nausea and Vomiting of Pregnancy (NVP) as Measured by the Change in Pregnancy Unique-Quantification of Emesis (PUQE) Overall Score of Symptoms From Baseline (Day 1) to End of Study Visit (Day 15).|The objective of this double-blind, randomized, placebo-controlled study was to assess the efficacy, safety, and tolerability of oral Diclectin® in the treatment of nausea and vomiting of pregnancy (NVP) as measured by the Pregnancy Unique-Quantification of Emesis (PUQE) overall score of symptoms from baseline (Day 1) to end of study visit (Day 15). The PUQE score measured hours of nausea, number of times vomiting, and number of times retching for a TOTAL overall score of symptoms on a scale rated from 3 (no symptoms) to 15 (most severe).|Baseline (Day 1) to End of Study Visit Day 15 (± 1 day)|Planned: Approximately 280 subjects (140 subjects per treatment group) were to be enrolled to achieve 200 evaluable subjects. Analyzed: 280 enrolled subjects [261 subjects in the intent-to-treat safety (ITT-S) population; 256 subjects in the intent-to-treat efficacy (ITT-E) population].||PUQE Score||95% Confidence Interval|Mean
759101|NCT00614458|Primary|A Change in the Number of HIV Infected Cells.|A change in infected cells from prior to the initiation of VPA and MK0518 to after 20 weeks of treatment.|20 weeks|All participants analyzed per protocol||infected cells /million cells||95% Confidence Interval|Median
759102|NCT00614484|Secondary|Treatment Related Toxicities.|"grade 3 or higher esophageal toxicity
Toxicity is categorized either early or late phase.
Early phase- toxicity occurring during or within 30 days s/p treatment Late phase- toxicity occurring thereafter"|Monthly for duration of participant lifespan. Average lifespan 1-2 years|||participants|||Number
759103|NCT00614484|Primary|Overall Survival.|Median survival time following treatment.|Monthly for duration of participant lifespan. Average lifespan 1-2 years|||Months||95% Confidence Interval|Median
759104|NCT00614523|Secondary|Annualized Rate of Patient-reported Bleeding Events|The number of bleeding events was obtained from the thrombocytopenia symptoms (Th-symptoms) survey. Patients reported spontaneous bleeding to have occurred 0, 1 or 2, 3 or 4, 5 or 6, or 7 or more times in the past week. The lower threshold of bleeding counts is used for conservative purposes (i.e., the “3” is used for the response option of “3 or 4 times”). Exposure adjusted event rate per 100 patient-years = number of events / patient-year * 100.|Test Treatment Period (Weeks 1-26)|The Patient Reported Outcomes (PRO) analysis set consists of patients in the full analysis set who also completed the baseline and at least one post-baseline assessment for any PRO measure.||events per 100 patient-years||95% Confidence Interval|Mean
759105|NCT00614523|Secondary|Kaplan-Meier Estimate of Survival at Month 12|Overall survival was calculated using Kaplan-Meier methods.|Month 12, with a data cut-off date of 20 July 2012.|Full analysis set includes all randomized patients.||percentage of participants||95% Confidence Interval|Number
759106|NCT00614523|Secondary|Time to Death|Overall survival was calculated using Kaplan-Meier methods. For patients who discontinued early, additional information from the long term follow-up are added (closest available follow-up information up to 58 weeks).|From randomization to 58 weeks, the end of study visit or the closest available follow-up information up to 58 weeks from the long term follow-up for those who discontinued the study early, with a data cut-off date of 20 July 2012.|Full analysis set includes all randomized patients.||months||95% Confidence Interval|Median
759107|NCT00614523|Secondary|Number of Participants Who Died||From randomization to 58 weeks, the end of study visit or the closest available follow-up information up to 58 weeks from the long term follow-up for those who discontinued the study early, with a data cut-off date of 20 July 2012.|Full analysis set includes all randomized patients.||participants|||Number
759108|NCT00614523|Secondary|Exposure-adjusted Total Duration of Platelet Hematologic Improvement (HI-P) in the Absence of Platelet Transfusions|Duration for participants who did not report HI-P during the period is 0. A platelet hematologic improvement (HI-P) is defined by an MDS International Working criteria as patients with a baseline platelet count of ≥ 20 x 10^9/L achieving an absolute increase of ≥ 30 x 10^9/L or increasing the platelet count to above 20 x 10^9/L and by at least 100% in patients with a baseline of < 20 x 10^9/L for at least 8 consecutive weeks. To account for any possible contribution from platelet transfusions, platelet counts within 3 days following administration of platelet transfusion is not counted towards the platelet hematologic improvement endpoint. If no platelet measurements are available on the weekly scheduled dose day, then that week is not counted towards the platelet hematologic improvement endpoint. The durations of HI-P are cumulative if more than one incidence occurred. Exposure adjusted event rate per 100 patient-weeks = total number of weeks / patient-weeks * 100.|Test Treatment Period (Weeks 1-26)|Full analysis set includes all randomized patients.||weeks per 100 patient-weeks||95% Confidence Interval|Mean
759109|NCT00614523|Secondary|Number of Participants With Platelet Hematologic Improvement (HI-P)|Platelet Hematologic Improvemen defined by the international working group (IWG) as: an absolute increase in platelet count of ≥ 30 x 10^9/L for a patient starting with a platelet count of ≥ 20 x 10^9/L or an increase in platelet count from < 20 x 10^9/L to ≥ 20 x 10^9/L and by at least 100% in a patient that started with a platelet count < 20 x 10^9/L. To account for any possible contribution from platelet transfusions, platelet counts within 3 days following administration of platelet transfusion is not counted towards the platelet hematologic improvement endpoint. If no platelet measurements are available on the weekly scheduled dose day, then that week is not counted towards the platelet hematologic improvement endpoint.|Test Treatment Period (Weeks 1-26)|Full analysis set includes all randomized patients.||Participants|||Number
762936|NCT00659360|Secondary|Objective Response Rate|Complete Response (CR) - Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions|Up to 5 years|||participants|||Number
759111|NCT00614523|Secondary|Annualized Rate of Overall Bleeding Events|The time from first dose of study drug to the last dose of 26-week test treatment period. A bleeding event is defined as any bleeding event reported during the test treatment period. Bleeding events that continue for more than 7 days are counted as separate events every eighth day. Multiple events that arose from one organ system on one day are collapsed into one single event. Exposure adjusted event rate per 100 patient-years = events / patient-year * 100).|Test Treatment Period (Weeks 1-26)|Full analysis set includes all randomized patients.||events per 100 patient-years||95% Confidence Interval|Mean
759112|NCT00614523|Secondary|Annualized Rate of Platelet Transfusion Events|A discrete platelet transfusion is any number of platelet transfusion administered within a 3-day period. Transfusions administered more than 3 days apart are counted as separate events. Transfusion given in the absence of any bleeding, when platelet count is >10x10^9/L, is not counted as a platelet transfusion event. Events with start date between the first dose date and the last dose date of the test treatment period +7 days are included. Exposure adjusted event rate per 100 patient-years = (events / patient-years * 100). Patient Year = total patient years of exposure to investigational product during 26 weeks test treatment period.|Test Treatment Period (Weeks 1-26)|Full analysis set includes all randomized patients.||events per 100 patient-years||95% Confidence Interval|Mean
759113|NCT00614523|Primary|Number of Clinically Significant Bleeding Events|A clinically significant bleeding event is defined as any bleeding event of grade ≥ 2 per the modified World Health Organization (WHO) bleeding scale: • Grade 0 = no bleeding • Grade 1 = petechia or mucosal or retinal bleeding not requiring intervention • Grade 2 = melena, hematemesis, hematuria, hemoptysis • Grade 3 = bleeding required red cell transfusion • Grade 4 = retinal bleeding with visual impairment • Grade 5 = non-fatal cerebral bleeding • Grade 6 = fatal cerebral bleeding • Grade 7 = fatal non-cerebral bleeding. Bleeding events that continue for more than 7 days were counted as separate events every eighth day. Multiple events that arose from one organ system on one day were collapsed into one single event. Bleeding events with a start date between the first dose date and the last dose date of the test treatment period+7 days are included.|Test Treatment Period (Weeks 1-26)|Full analysis set includes all randomized patients.||events|||Number
759114|NCT00614575|Primary|Percentage of Participants With Adverse Events, Adverse Drug Reactions, and Serious Adverse Events|The aim of this Post Marketing Surveillance (PMS) was to obtain safety data with treatment of pramipexole in Parkinson's disease patients with depressive symptoms. The percentage of participants with adverse events, adverse drug reactions, and serious adverse events are presented.|for 12 weeks|Safety Analysis Set||percentage of participants|||Number
759115|NCT00614575|Secondary|Mean Change From Baseline in Modified Hoehn & Yahr Rating Scale|This scale is an investigator-completed assessment of the degree of complications arising from Parkinson's disease. The scale ranges from 0 (No signs) to 5 (Bedridden). A negative change in the Yahr rating scale indicates improvement.|After 12 weeks or at the time of discontinuation|Efficacy Analysis Set||units on a scale||Standard Deviation|Mean
759116|NCT00614575|Secondary|Mean Change From Baseline in UPDRS (Unified Parkinson's Disease Rating Scale) Part I Item 3 Score|Unified Parkinson's Disease Rating Scale Part I Item 3 assesses the participant for symptoms of depression. Item 3 scores range from 0 (None) to 4 (Sustained depression with suicidal thoughts or intent). A higher score indicates more severe depression symptoms. A negative change in the item 3 score indicates improvement.|Baseline and after 12 weeks (or at the time of discontinuation)|Efficacy analysis set||Unit on a scale||Standard Deviation|Mean
759117|NCT00614575|Secondary|Mean Change From Baseline in Beck's Depression Inventory (BDI) Total Score|The degree of severity in depressive state are scored between 0-63 in BDI. A decrease in the score means improvement.|Baseline and after 12 weeks (or at the time of discontinuation)|Efficacy analysis set||Unit on a scale||Standard Deviation|Mean
759118|NCT00614575|Secondary|Mean Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score|Part III of the UPDRS contains the clinician-scored motor evaluation, and includes 14 individual items each scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56. A negative change in the Part III total score indicates improvement.|Baseline and after 12 weeks (or at the time of discontinuation)|Efficacy analysis set||Unit on a scale||Standard Deviation|Mean
759119|NCT00614575|Secondary|Clinical Global Impression of Improvement|Investigators evaluation of the Parkinson's disease (PD) symptoms on the Clinical Global Impression (CGI) with 5 categories (very much improved, much improved, minimally improved, no effect, and unassessable).|for 12 weeks after initiation of the treatment|Efficacy analysis set||participants|||Number
759120|NCT00614614|Primary|Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Value in Menhibrix 2 Group|The cut-off values assessed for hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:8|One month post vaccination at 12-15 months of age (Month 11)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Menhibrix 2 Group.||Subjects|||Number
759121|NCT00614614|Primary|Geometric Mean Antibody Concentrations for Anti-PT (Pertusis Toxoid), Anti-FHA (Filamentous Hemagglutinin) and Anti-PRN (Pertactin) in Nimenrix 2 Group and ActHIB- Infanrix Group|Concentrations were provided as Geometric mean concentrations (GMCs) and expressed as enzyme-linked immunosorbent assay units per milliliter (EL.U/mL)|One month after vaccination at 15-18 months of age (Month 14)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was performed on Nimenrix 2 and ActHIB- Infanrix Group.||EL.U/mL||95% Confidence Interval|Geometric Mean
759122|NCT00614614|Primary|Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Menhibrix 2 Group|Antibody titers were expressed as Geometric mean titers (GMTs)|One month post vaccination at 12-15 months of age (Month 11)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Menhibrix 2 Group.||titer||95% Confidence Interval|Geometric Mean
772072|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 3|Subject Satisfaction - ease of locating the deflation touch pads|12 months post-surgery|||% satisfactory or somewhat satisfactory|||Number
759123|NCT00614614|Primary|Number of Subjects With Anti-Diptheria (Anti-D) and Anti-Tetanus (Anti-T) Antibody Concentrations Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 2 Group and ActHIB- Infanrix Group|The cut-off value assessed for Anti-D and Anti-T were greater than or equal to (≥) 1.0 International Units per milliliter (IU/mL).|One month post vaccination at 15-18 months of age (Month 14)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. It was performed on the Nimenrix 2 and ActHIB- Infanrix Group.||Subjects|||Number
759124|NCT00614614|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|From the first booster phase visit up to six months after the last vaccination (Month 10-13 up to Month 19-22)|The analysis was performed on Booster Total Vaccinated cohort which included all subjects who had received a study vaccine during the booster phase.||Subjects|||Number
759125|NCT00614614|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|From the first primary study dose up to/excluding the first booster study dose (Month 0 up to Month 10-13).|The analysis was performed on Primary Total Vaccinated cohort which included all subjects who had received a study vaccine during the primary phase.||Subjects|||Number
759126|NCT00614614|Secondary|Number of Subjects Reporting Any Unsolicited AEs in Nimenrix 1 Group and Menhibrix 2 Group After the Second Booster Phase Vaccination|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 31-day follow-up period (Day 0-30)|The analysis was performed on Booster Total Vaccinated cohort which included all subjects who had received a study vaccine during the booster phase. Analysis was performed on the Nimenrix 1 and Menhibrix 2 Group.||Subjects|||Number
759127|NCT00614614|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) After the First or Single Booster Phase Vaccination|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During a 31-day follow-up period (Day 0-30)|The analysis was performed on Booster Total Vaccinated cohort which included all subjects who had received a study vaccine during the booster phase.||Subjects|||Number
759128|NCT00614614|Secondary|Number of Subjects Reporting Any New Onset of Chronic Illness (NOCI) and Any Emergency Room (ER) Visits|NOCIs include autoimmune disorders, asthma, type I diabetes and allergies. AEs prompting emergency room visits or physician visits are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|From the first primary study dose up to/excluding the first booster study dose (Month 0 up to Month 10-13)|The analysis was performed on Primary Total Vaccinated cohort which included all subjects who had received a study vaccine during the primary phase.||Subjects|||Number
759129|NCT00614614|Secondary|Number of Subjects Reporting Any New Onset of Chronic Illness (NOCI) and Any Emergency Room (ER) Visits|NOCIs include autoimmune disorders, asthma, type I diabetes and allergies. AEs prompting emergency room visits or physician visits are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|From the first booster phase visit up to six months after the last vaccination (Month 10-13 up to Month 19-22)|The analysis was performed on Booster Total Vaccinated cohort which included all subjects who had received a study vaccine during the booster phase.||Subjects|||Number
759130|NCT00614614|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Vaccination With Infanrix Vaccine|Any was defined as any solicited local symptom reported regardless of intensity grade. Grade 3 redness and swelling was > 30 millimeter (mm) and grade 3 pain was subjects crying when limb was moved/spontaneously painful.|During the 8-day follow-up period (Day 0-7) after vaccination in the booster phase|The analysis was performed on Booster Total Vaccinated cohort which included all subjects who had received a study vaccine during the booster phase and had symptom sheet completed.||Subjects|||Number
759131|NCT00614614|Secondary|Number of Subjects Reporting Any Rash|Examples of rash included hives, idiopathic thrombocytopenic purpura, petechiae.|From the first booster phase visit up to six months after the last vaccination (Month 10-13 up to Month 19-22)|The analysis was performed on Booster Total Vaccinated cohort which included all subjects who had received a study vaccine during the booster phase.||Subjects|||Number
759132|NCT00614614|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase|Any fever was defined as axillary temperature greater than or equal to 38.0 degree centigrade i.e ≥38.0°C, grade 3 fever was axillary temperature > 40.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relation to vaccination and grade 3 was defined as a general symptom that prevented normal activity. Related was a general symptom assessed by the investigator as causally related to the study vaccination.|During the 8-day follow-up period (Day 0-7) after dose 4 and dose 5 vaccination|The analysis was performed on Booster Total Vaccinated cohort which included all subjects who had received a study vaccine during the booster phase and had symptom sheet completed.||Subjects|||Number
759133|NCT00614614|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Each Dose With Nimenrix or Menhibrix Vaccine|Any was defined as any solicited local symptom reported regardless of intensity grade. Grade 3 redness and swelling was greater than (>) 30 millimeter (mm) and grade 3 pain was subjects crying when limb was moved/spontaneously painful.|During the 8-day follow-up period (Day 0-7) after vaccination in the booster phase|The analysis was performed on Booster Total Vaccinated cohort which included all subjects who had received a study vaccine during the booster phase and had symptom sheet completed.||Subjects|||Number
759134|NCT00614614|Secondary|Geometric Mean Antibody Titers for hSBA-MenA and hSBA-MenW-135 in Nimenrix 2 Group|Antibody titers were expressed as Geometric mean titers (GMTs)|One month after vaccination with Infanrix at 15-18 months of age (Month 14)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Nimenrix 2 Group.||titer||95% Confidence Interval|Geometric Mean
759135|NCT00614614|Secondary|Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 2 Group|The cut-off values assessed for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY were greater than or equal to (≥) 1:4|One month after vaccination at 15-18 months of age (Month 14)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Nimenrix 2 Group.||Subjects|||Number
759136|NCT00614614|Secondary|Number of Subjects With Anti-D and Anti-T Antibody Concentrations Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 1 Group and Menhibrix 2 Group|The cut-off values assessed for Anti-D and Anti-T were greater than or equal to (≥) 1.0 International Units per milliliter (IU/mL).|One month after vaccination at 15-18 months of age (Month 14)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was performed on the Nimenrix 1 and Menhibrix 2 Group.||Subjects|||Number
759137|NCT00614614|Secondary|Geometric Mean Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN in Nimenrix 1 Group and Menhibrix 2 Group|Concentrations were provided as Geometric mean concentrations (GMCs) and expressed as enzyme-linked immunosorbent assay units per milliliter (EL.U/mL)|One month after vaccination at 15-18 months of age (Month 14)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was performed on the Nimenrix 1 and Menhibrix 2 Group.||EL.U/mL||95% Confidence Interval|Geometric Mean
759138|NCT00614614|Secondary|Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations Greater Than or Equal to Protocol Specified Cut-off Value|The cut-off values assessed were greater than or equal to (≥) 5 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL)|One month after vaccination with Infanrix at 15-18 months of age (Month 14)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination.||Subjects|||Number
759139|NCT00614614|Secondary|Number of Subjects With Anti-D and Anti-T Antibody Concentrations Greater Than or Equal to Protocol Specified Cut-off Value|The cut-off value assessed for Anti-D and Anti-T were greater than or equal to (≥) 0.1 International Units per milliliter (IU/mL).|One month after vaccination with Infanrix at 15-18 months of age (Month 14)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination.||Subjects|||Number
759140|NCT00614614|Secondary|Anti-D and Anti-T Geometric Mean Antibody Concentrations|Concentrations were provided as Geometric Mean Concentrations(GMCs) and expressed as International Units per milliliter (IU/mL).|One month after vaccination with Infanrix at 15-18 months of age (Month 14)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination.||IU/mL||95% Confidence Interval|Geometric Mean
759141|NCT00614614|Secondary|Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 2 Group|The cut-off values assessed for hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:4 and ≥ 1:8|Prior to vaccination at 15-18 months of age (Month 13)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Nimenrix 2 Group.||Subjects|||Number
759142|NCT00614614|Secondary|Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Nimenrix 2 Group|Antibody titers were expressed as Geometric mean titers (GMTs)|Prior to vaccination at 15-18 months of age (Month 13)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Nimenrix 2 Group.||titer||95% Confidence Interval|Geometric Mean
759143|NCT00614614|Secondary|Geometric Mean Antibody Titers for hSBA-MenA and hSBA MenW-135 in Nimenrix 1 Group|Antibody titers were expressed as Geometric mean titers (GMTs)|One month after vaccination at 12-15 months of age (Month 11)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Nimenrix 1 Group.||titer||95% Confidence Interval|Geometric Mean
763720|NCT00671437|Secondary|Overall Best Anatomic Tumor Response Rate to Cetuximab Given Until Disease Progression as Assessed by RECIST Criteria Using CT & Clinical Examination||Every 8 weeks until disease progression (up to 1 year)|||participants|||Number
759144|NCT00614614|Secondary|Number of Subjects With hSBA-MenA and hSBA MenW-135 Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 1 Group|The cut-off values assessed for hSBA-MenA and hSBA-MenW-135 were greater than or equal to (≥) 1:4|One month after vaccination at 12-15 months of age (Month 11)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Nimenrix 1 Group.||Subjects|||Number
759145|NCT00614614|Secondary|Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 1 Group and Menhibrix 2 Group|The cut-off values assessed for hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:4|One month after vaccination at 12-15 months of age (Month 11)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was performed on the Nimenrix 1 and Menhibrix 2 Group.||Subjects|||Number
759146|NCT00614614|Primary|Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Nimenrix 2 Group|Antibody titers were expressed as Geometric mean titers (GMTs)|One month post vaccination at 15-18 months of age (Month 14)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Nimenrix 2 Group.||titer||95% Confidence Interval|Geometric Mean
759147|NCT00614614|Primary|Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Nimenrix 1 Group|Antibody titers were expressed as Geometric mean titers (GMTs)|One month post vaccination at 12-15 months of age (Month 11)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Nimenrix 1 Group.||titer||95% Confidence Interval|Geometric Mean
759148|NCT00614614|Primary|Number of Subjects With hSBA-MenA, hSBA-MenW-135, hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 2 Group|The cut-off values assessed for hSBA-MenA, hSBA-MenW-135, hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:8|One month post vaccination at 15-18 months of age (Month 14)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Nimenrix 2 Group.||Subjects|||Number
759149|NCT00614614|Primary|Number of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Antibody Titers for N. Meningitidis Serogroups A(MenA), W-135(MenW-135), C(MenC) and Y(MenY) Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 1 Group|The cut-off values assessed for hSBA-MenA, hSBA-MenW-135, hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:8|One month post vaccination at 12-15 months of age (Month 11)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Nimenrix 1 Group.||Subjects|||Number
759150|NCT00614744|Secondary|Number of Infants With Neonatal Seizures, With and Without EEG Abnormalities||Birth to 18-22 months corrected gestational age|||Participants|||Count of Participants
759151|NCT00614744|Secondary|Number of Infants With a DNR Order That Died||Birth to 18-22 months corrected gestational age|Only infants with DNR order||Participants|||Count of Participants
759152|NCT00614744|Secondary|Number of Infants With a DNR Order and Support is Withdrawn||Birth to 18-22 months corrected gestational age|||Participants|||Count of Participants
759153|NCT00614744|Secondary|Number of Infants With a DNR Order||Birth to 18-22 months corrected gestational age|||Participants|||Count of Participants
759154|NCT00614744|Secondary|Number of Infants With Non-CNS Organ System Dysfunction|Based on observing presence of organ dysfunction on at least one of the following: Pulmonary (Meconium aspiration syndrome, PPHN, Pulmonary hemorrhage, Pneumonia, Chronic lung disease, ECMO, INO), Cardiovascular (Cardiomegaly, Cardiac failure, Cardiac dysfunction (by echo), Cardiac ischemia (by EKG and/or increased enzymes), Hypotension, Arrhythmia), Renal (Oliguria, Anuria, Dialysis), Gastrointestinal (NEC, Hepatic dysfunction), Hematologic (DIC) and Metabolic (Hypoglycemia, Hypocalcemia, Hypomagnesemia)|Birth to 18-22 months corrected gestational age|||Participants|||Count of Participants
759155|NCT00614744|Secondary|Number of Infants With Any Disability Based on Level of Encephalopathy at Randomization|Mild disability will be defined by either a Bayley III cognitive score of 70-84 alone or a Bayley III cognitive score >= 85 and any of the following: presence of a GMF level 1 or 2OR seizure disorder or hearing loss. Moderate disability was defined as a Bayley III cognitive score between 70-84 and either a GMF level of 2 or a seizure disorder or a hearing deficit. Severe disability will be defined by any of the following: a Bayley III cognitive score < 70 OR Gross Motor Functional (GMF) Level of 3-5 OR blindness or profound hearing loss requiring amplification but still unable to follow commands/communicate.|Birth to 18-22 months corrected gestational age|||Participants|||Count of Participants
759156|NCT00614744|Secondary|Number of Infants With Mild, Moderate and Severe Disability|Mild disability will be defined by either a Bayley III cognitive score of 70-84 alone or a Bayley III cognitive score >= 85 and any of the following: presence of a GMF level 1 or 2 OR seizure disorder or hearing loss. Moderate disability was defined as a Bayley III cognitive score between 70-84 and either a GMF level of 2 or a seizure disorder or a hearing deficit. Severe disability will be defined by any of the following: a Bayley III cognitive score < 70 OR Gross Motor Functional (GMF) Level of 3-5 OR blindness or profound hearing loss requiring amplification but still unable to follow commands/communicate.|Birth to 18-22 months corrected gestational age|Does not include 9 lost to follow up and 2 infants without outcome for behavior issues||Participants|||Count of Participants
759221|NCT00615069|Secondary|Number of Subjects With One or More of the Following Events: Type I Endoleak, Device Migration, Major Procedural Bleeding Complications||Treatment through 1 year window post-procedure (through end of 1 year window, 546 days)|||Participants|||Number
759157|NCT00614744|Secondary|Number of Infants With Moderate and Severe Disability|Moderate disability will be defined as a Bayley III cognitive score between 70-84 and either a GMF level of 2 or a seizure disorder or a hearing deficit. Severe disability will be defined by any of the following: a Bayley III cognitive score < 70 or Gross Motor Functional (GMF) Level of 3-5 or blindness or profound hearing loss requiring amplification but still unable to follow commands/communicate.|Birth to 18-22 months corrected gestational age|Does not include 9 lost to follow up and 2 infants without outcome for behavior issues||Participants|||Count of Participants
759158|NCT00614744|Secondary|Number of Deaths in the NICU and Following Discharge||Birth to 18-22 months corrected gestational age|Does not include 9 lost to follow up and 2 infants without outcome for behavior issues||Participants|||Count of Participants
759159|NCT00614744|Primary|Death or Moderate or Severe Disability|Severe disability was defined by any of the following: a Bayley III cognitive score < 70 or Gross Motor Functional (GMF) Level of 3-5 blindness or profound hearing loss requiring amplification but still unable to follow commands/communicate. Moderate disability was defined as a Bayley III cognitive score between 70-84 and either a GMF level of 2 or a seizure disorder or a hearing deficit.|Birth to 18-22 months corrected gestational age|Does not include 9 lost to follow up and 2 infants without outcome for behavior issues||Participants|||Count of Participants
759160|NCT00614874|Secondary|Forced Expiratory Volume in One Second (FEV1) Percent Predicted|Spirometry was performed on each visit according to American Thoracic Society guidelines. FEV1 percent predicted was measured.|patients were assessed at baseline and 12 weeks|Two subjects withdrew from the study in visit 3||percent predicted||Standard Deviation|Mean
759161|NCT00614874|Secondary|Forced Expiratory Volume in 1 Second (FEV1)|FEV1 in liters|patients were assessed at baseline and 12 weeks|Two subjects withdrew from the study in visit 3||Liters||Standard Deviation|Mean
759162|NCT00614874|Secondary|Exhaled Nitric Oxide in Parts Per Billion (Ppb), Parts Per Billion|Fraction Exhaled Nitric oxide was measured on each visit prior to bronchoprovocation by chemiluminescence using an analyzer.|patients were assessed at baseline and 12 weeks|2 patients withdrew from the study in visit 3||parts per billion||Standard Deviation|Mean
759163|NCT00614874|Primary|Methacholine Responsiveness as Assessed by PC20,|PC20 is the concentration of methacholine at which patients had a decrease in Forced Expiratory Volume in one second (FEV1) of 20%|patients were assessed at baseline and at 12 weeks|3 subjects were not included in the final analysis due to missing data. Two subjects withdrew by visit 3. 1 had missing data at visit 2 due to equipment failure.||mg/mL||Standard Deviation|Mean
759164|NCT00614913|Primary|Median Survival Without Tumor Progression|Median time until disease progression or death|3 months|All participants||months||95% Confidence Interval|Median
759165|NCT00614913|Primary|3-year Survival Without Tumor Progression for Patients Within the Milan Criteria|Percent of participants alive and without tumor progression 3 years following treatment.|3 months|Participants that were within the Milan criteria||percentage of participants|||Number
759166|NCT00614926|Secondary|"Number of Impaired Scores on Neuropsychological (Brief) Test Battery"|This was an initial plan but the large majority of patients were too impaired (either anarthric or unable to use hands) to complete the tests we had selected so this outcome measure turned out to be unfeasible. Therefore, 0 participants were analyzed.|4 weeks|||participants|||Number
759167|NCT00614926|Primary|"Participants Considered Responders (Scored 1 or 2) on Clinical Global Impressions Scale"|"The CGI is a standardized assessment tool widely used in clinical psychopharmacology trials as an outcome measure. Scores range from 1= very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5-7 = worse. We use it as a dichotomous measure with scores of 1 or 2 signifying responder and all the rest as non-responder using all available data including clinician judgement, and ratings scales."|4 weeks|Analysis was Intention to Treat (ITT) including Last-Observation-Carried-Forward (LOCF) as indicated. Proof of concept study so N was based on accrual feasibility.||"participants considered responders"|||Number
759168|NCT00614939|Secondary|Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - End-Stage Renal Impairment Subgroup|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set) for the end-stage renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value.|Baseline, Week 52|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 52 for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. Data were excluded after changes in oral blood glucose lowering drug or insulin.||mmol/L||Standard Error|Mean
759169|NCT00614939|Secondary|Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - Severe Renal Impairment Subgroup|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set) for the severe renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value.|Baseline, Week 52|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 52 for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. Data were excluded after changes in oral blood glucose lowering drug or insulin.||mmol/L||Standard Error|Mean
759170|NCT00614939|Secondary|Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - Moderate Renal Impairment Subgroup|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set) for the moderate renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value|Baseline, Week 52|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 52 for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. Data were excluded after changes in oral blood glucose lowering drug or insulin.||mmol/L||Standard Error|Mean
759222|NCT00615069|Primary|Time to First Major Adverse Event Experienced by Subjects From the Time of Treatment Through 1 Year||Treatment through 1 year post-procedure (365 days)|||days||Standard Error|Mean
759223|NCT00615108|Secondary|Overall Assessment by Attending Physicians|"Overall assessment was reported as a 5-point scale rated from 0 to 4 as below:
4: Outstanding 3: Very satisfactory 2: Satisfactory
1: Marginal 0: Not satisfactory"|01-Dec-2006 to 31-Dec-2008|Included the patients who took 20mg, 40mg, 80mg and unknown dosage||Percentage of Participants|||Number
759171|NCT00614939|Secondary|Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - End-Stage Renal Impairment Subgroup|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set) for the end-stage renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value.|Baseline, Week 52|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 52 for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. Data were excluded after changes in oral blood glucose lowering drug or insulin.||mg/dL||Standard Error|Mean
759172|NCT00614939|Secondary|Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - Severe Renal Impairment Subgroup|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set) for the severe renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value.|Baseline, Week 52|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 52 for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. Data were excluded after changes in oral blood glucose lowering drug or insulin.||mg/dL||Standard Error|Mean
759173|NCT00614939|Secondary|Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - Moderate Renal Impairment Subgroup|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set) for the moderate renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value.|Baseline, Week 52|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 52 for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. Data were excluded after changes in oral blood glucose lowering drug or insulin.||mg/dL||Standard Error|Mean
759174|NCT00614939|Secondary|Absolute Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) Level to Week 52|Adjusted* mean change from baseline in HbA1c achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value.|Baseline , Week 52|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 52 for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. Data were excluded after changes in oral blood glucose lowering drug or insulin.||Percent||Standard Error|Mean
759175|NCT00614939|Secondary|Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - End-Stage Renal Impairment Subgroup|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set) for the end-stage renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 12 value minus the baseline value.|Baseline, Week 12 (LOCF)|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 12 (LOCF) for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement.||mmol/L||Standard Error|Mean
759176|NCT00614939|Secondary|Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - Severe Renal Impairment Subgroup|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set) for the severe renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 12 value minus the baseline value.|Baseline, Week 12 (LOCF)|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 12 (LOCF) for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement.||mmol/L||Standard Error|Mean
759177|NCT00614939|Secondary|Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - Moderate Renal Impairment Subgroup|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set) for the moderate renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 12 value minus the baseline value.|Baseline, Week 12 (LOCF)|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 12 (LOCF) for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement.||mmol/L||Standard Error|Mean
759178|NCT00614939|Secondary|Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - End-Stage Renal Impairment Subgroup|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set) for the end-stage renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 12 value minus the baseline value.|Baseline, Week 12 (LOCF)|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 12 (LOCF) for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement.||mg/dL||Standard Error|Mean
759179|NCT00614939|Secondary|Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - Severe Renal Impairment Subgroup|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set) for the severe renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 12 value minus the baseline value.|Baseline, Week 12 (LOCF)|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 12 (LOCF) for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement.||mg/dL||Standard Error|Mean
759224|NCT00615108|Secondary|Overall Assessment by Patients|"Overall assessment was reported as a 5-point scale rated from 0 to 4 as below:
4: Outstanding 3: Very satisfactory 2: Satisfactory
1: Marginal 0: Not satisfactory"|01-Dec-2006 to 31-Dec-2008|Included the patients who took 20mg, 40mg, 80mg and unknown dosage.||Percentage of Participants|||Number
763756|NCT00671749|Secondary|Global Assessment of Improvement From Baseline||12 weeks|||participants|||Number
759180|NCT00614939|Secondary|Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF)- Moderate Renal Impairment Subgroup|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set) for the moderate renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 12 value minus the baseline value.|Baseline, Week 12 (LOCF)|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 12 (LOCF) for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement.||mg/dL||Standard Error|Mean
759181|NCT00614939|Primary|Absolute Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) Level to Week 12 Last Observation Carried Forward (LOCF)|Adjusted* mean change from baseline in HbA1c achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated at the Week 12 value minus the baseline value.|Baseline , Week 12 (LOCF)|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 12 (LOCF) for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement.||Percent||Standard Error|Mean
759182|NCT00614991|Primary|CL/F: Steady-state Plasma Amprenavir (APV) Pharmacokinetics (PK) Following Administration of Fosamprenavir (FPV) 1400mg BID, FPV 700mg/Ritonavir (RTV) 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent Raltegravir (RTG) 400mg BID.|APV minimum concentration (Cmin), maximum concentration (Cmax), area under the plasma concentration-time curve (AUC), and oral clearance (CL/F) as determined from APV concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F|Day 7 of the RAL 400mg BID regimen and Day 14 of the RAL 400mg/FPV 1400mg BID, RAL 400mg/FPV 700mg/RTV 100mg BID, and RAL 400mg BID Plus FPV 1400mg/RTV 100mg QD regimens|||L/h||90% Confidence Interval|Mean
759183|NCT00614991|Primary|AUC: Steady-state Plasma Amprenavir (APV) Pharmacokinetics (PK) Following Administration of Fosamprenavir (FPV) 1400mg BID, FPV 700mg/Ritonavir (RTV) 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent Raltegravir (RTG) 400mg BID.|APV minimum concentration (Cmin), maximum concentration (Cmax), area under the plasma concentration-time curve (AUC), and oral clearance (CL/F) as determined from APV concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F|Day 7 of the RAL 400mg BID regimen and Day 14 of the RAL 400mg/FPV 1400mg BID, RAL 400mg/FPV 700mg/RTV 100mg BID, and RAL 400mg BID Plus FPV 1400mg/RTV 100mg QD regimens|||ng•h/mL||90% Confidence Interval|Mean
759184|NCT00614991|Primary|Cmin/Cmax: Steady-state Plasma RTG PK Following Admin of FPV 1400mg BID, FPV 700mg/RTV 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent RTG 400mg BID.|RAL minimum concentration (Cmin), maximum concentration (Cmax), area under the plasma concentration-time curve (AUC), and oral clearance (CL/F) as determined from RAL concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the period when RAL 400mg BID was administered with the FPV-Containing BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the period when RAL 400mg BID was administered with the FPV QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F.|Day 7 of the RAL 400mg BID regimen and Day 14 of the RAL 400mg/FPV 1400mg BID, RAL 400mg/FPV 700mg/RTV 100mg BID, and RAL 400mg BID Plus FPV 1400mg/RTV 100mg QD regimens|||ng/mL||90% Confidence Interval|Mean
759185|NCT00614991|Primary|CL/F: Steady-state Plasma Amprenavir (APV) Pharmacokinetics (PK) Following Administration of Fosamprenavir (FPV) 1400mg BID, FPV 700mg/Ritonavir (RTV) 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent Raltegravir (RTG) 400mg BID.|APV minimum concentration (Cmin), maximum concentration (Cmax), area under the plasma concentration-time curve (AUC), and oral clearance (CL/F) as determined from APV concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F|Day 14 of the FPV 1400mg BID, FPV 1400mg/RAL 400mg BID, FPV 700mg/RTV 100mg BID, FPV 700mg/RTV 100mg/RAL 400mg BID, FPV 1400mg/RTV 100mg QD, and FPV 1400mg/RTV 100mg QD plus RAL 400mg BID regimens|||L/H||90% Confidence Interval|Mean
759186|NCT00614991|Primary|AUC: Steady-state Plasma Amprenavir (APV) Pharmacokinetics (PK) Following Admin of Fosamprenavir (FPV) 1400mg BID, FPV 700mg/Ritonavir (RTV) 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent Raltegravir (RTG) 400mg BID.|APV minimum concentration (Cmin), maximum concentration (Cmax), area under the plasma concentration-time curve (AUC), and oral clearance (CL/F) as determined from APV concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F|Day 14 of the FPV 1400mg BID, FPV 1400mg/RAL 400mg BID, FPV 700mg/RTV 100mg BID, FPV 700mg/RTV 100mg/RAL 400mg BID, FPV 1400mg/RTV 100mg QD, and FPV 1400mg/RTV 100mg QD plus RAL 400mg BID regimens|||ng•h/mL||90% Confidence Interval|Mean
760484|NCT00626574|Secondary|To Determine if Procrit® Administration Prior to Aneurysm Clipping in Patients With Aneurysmal SAH Will Improve Neurological Assessment Scores in the Post-SAH/Post-clipping Time Period||First 10 days following clipping and 6 week f/u||||||
759187|NCT00614991|Secondary|Number of Participants Who Experienced Adverse Events|"Safety/tolerability data included all adverse events (AEs) reported within the time frame of each regimen evaluated. The intent was to compare adverse events for each sequence and not for each regimen. The regimens for which AE information was culled were:
RAL 400mg BID alone
FPV 1400mg BID alone
FPV 700mg/RTV 100 mg BID alone
FPV 1400mg/RTV 100mg QD alone
FPV 1400mg BID combined with RAL 400mg BID
FPV 700mg/RTV 100 mg BID combined with RAL 400mg BID
FPV 1400mg/RTV 100mg QD combined with RAL 400mg BID The severity of reported AEs was graded according to DAIDS criteria, Version 1.0 (National Institute of Allergy and Infectious Diseases (NIAID). Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0. Division of Acquired Immunodeficiency Syndrome (DAIDS), Washington D.C.; 2004."|Day 0 through Day 49|||participants|||Number
759188|NCT00614991|Primary|Cmin/Cmax: Steady-state Plasma Amprenavir (APV) Pharmacokinetics (PK) Following Admin of Fosamprenavir (FPV) 1400mg BID, FPV 700mg/Ritonavir (RTV) 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent Raltegravir (RTG) 400mg BID.|APV minimum concentration (Cmin), maximum concentration (Cmax), area under the plasma concentration-time curve (AUC), and oral clearance (CL/F) as determined from APV concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F|Day 14 of the FPV 1400mg BID, FPV 1400mg/RAL 400mg BID, FPV 700mg/RTV 100mg BID, FPV 700mg/RTV 100mg/RAL 400mg BID, FPV 1400mg/RTV 100mg QD, and FPV 1400mg/RTV 100mg QD plus RAL 400mg BID regimens|||ng/mL||90% Confidence Interval|Mean
759189|NCT00615017|Secondary|Number of Patients Below Tumour Necrosis Factor (TNF)-Alpha Limit of Quantification (LOQ) at 24 Hours (n< LOQ)|Number of patients below tumour necrosis factor (TNF)-alpha limit of quantification (LOQ) at 24 hours (n< LOQ) measured by ELISA (LOQ = 1.3 pg/mL). Safety analysis set (ie all patients who started study drug infusion).|24 hours|Participants analyzed relates to the number of evaluable patients at the specified time point.||Participants|||Number
759190|NCT00615017|Secondary|Tmax of Maintenance Dose AZD9773 Serum Total Fabs (Cohorts 3, 4 and 5)|tmax of maintenance dose AZD9773 serum total Fabs (cohorts 3, 4 and 5). PK analysis set (ie a subset of the safety analysis set including only those patients without important deviations that could affect the PK).|PK samples taken pre-dose of Doses 5,7 and 9, then at 0, 0.5, 1, 2, 8 and 12 h post dose 9 infusion|Participants analyzed relates to the number of evaluable patients at the specified time point.||Hours||Full Range|Median
759191|NCT00615017|Secondary|Cinf of Maintenance Dose AZD9773 Serum Total Fabs (Cohorts 3, 4 and 5)|Cinf of maintenance dose AZD9773 serum total Fabs (cohorts 3, 4 and 5). PK analysis set (ie a subset of the safety analysis set including only those patients without important deviations that could affect the PK).|PK samples taken pre-dose of Doses 5,7 and 9, then at 0, 0.5, 1, 2, 8 and 12 h post dose 9 infusion|Participants analyzed relates to the number of evaluable patients at the specified time point.||μg/mL||Full Range|Geometric Mean
759192|NCT00615017|Secondary|AUC(0-12) of Maintenance Dose AZD9773 Serum Total Fabs (Cohorts 3, 4 and 5)|AUC(0-12) of maintenance dose AZD9773 serum total Fabs (cohorts 3, 4 and 5). PK analysis set (ie a subset of the safety analysis set including only those patients without important deviations that could affect the PK).|PK samples taken pre-dose of Doses 5,7 and 9, then at 0, 0.5, 1, 2, 8 and 12 h post dose 9 infusion|Participants analyzed relates to the number of evaluable patients at the specified time point.||μg.h/mL||Full Range|Geometric Mean
759193|NCT00615017|Secondary|Time to Reach Cinf (Tmax) of Loading Dose AZD9773 Serum Total Fabs (Cohorts 3, 4 and 5)|tmax of loading dose AZD9773 serum total Fabs (cohorts 3, 4 and 5). PK analysis set (ie a subset of the safety analysis set including only those patients without important deviations that could affect the PK).|Day 1 [PK samples taken pre-dose, the end of each infusion rate and then at 0.5, 1, 2, 8 and 12 h post-(last)infusion]|Participants analyzed relates to the number of evaluable patients at the specified time point.||Hours||Full Range|Median
759194|NCT00615017|Secondary|Maximum (End of Infusion) Serum Concentration (Cinf) of Loading Dose AZD9773 Serum Total Fabs (Cohorts 3,4 and 5)|Cinf of loading dose AZD9773 serum total Fabs (cohorts 3, 4 and 5). PK analysis set (ie a subset of the safety analysis set including only those patients without important deviations that could affect the PK).|Day 1 [PK samples taken pre-dose, the end of each infusion rate and then at 0.5, 1, 2, 8 and 12 h post-(last)infusion]|Participants analyzed relates to the number of evaluable patients at the specified time point.||μg/mL||Full Range|Geometric Mean
759195|NCT00615017|Secondary|AUC(0-12) of Loading Dose AZD9773 Serum Total Fabs (Cohorts 3, 4 and 5)|AUC(0-12) of loading dose AZD9773 serum total Fabs (cohorts 3, 4 and 5). PK analysis set (ie a subset of the safety analysis set including only those patients without important deviations that could affect the PK).|Day 1 [PK samples taken pre-dose, the end of each infusion rate and then at 0.5, 1, 2, 8 and 12 h post-(last) infusion]|Participants analyzed relates to the number of evaluable patients at the specified time point.||μg.h/mL||Full Range|Geometric Mean
759196|NCT00615017|Secondary|Total Apparent Clearance (CL) of Single Dose AZD9773 Serum Total Fabs (Cohorts 1 and 2)|CL of single dose AZD9773 serum total Fabs (cohorts 1 and 2). PK analysis set (ie a subset of the safety analysis set including only those patients without important deviations that could affect the PK).|Day 1 [PK samples taken pre-dose, the end of each infusion rate and then at 0.5, 1, 2, 8, 12, 24, 48, and 72 h post-(last) infusion]|Participants analyzed relates to the number of evaluable patients at the specified time point.||mL/min/kg||Full Range|Mean
759197|NCT00615017|Secondary|Terminal Half-life (t1/2) of Single Dose AZD9773 Serum Total Fabs (Cohorts 1 and 2)|t1/2 of single dose AZD9773 serum total Fabs (cohorts 1 and 2). PK analysis set (ie a subset of the safety analysis set including only those patients without important deviations that could affect the PK).|Day 1 [PK samples taken pre-dose, the end of each infusion rate and then at 0.5, 1, 2, 8, 12, 24, 48, and 72 h post-(last) infusion]|Participants analyzed relates to the number of evaluable patients at the specified time point.||Hours||Full Range|Mean
759225|NCT00615108|Secondary|Percentage of Patients Achieving BP Response|Achieving BP response was defined as reduction from baseline in sitting SBP or DBP > 10 mmHg during the observational period. The observation period is 8 weeks.|01-Dec-2006 to 31-Dec-2008|Included the patients who took 20mg, 40mg, 80mg and unknown dosage.||percentage of participants|||Number
759198|NCT00615017|Secondary|Area Under the Serum Concentration-time Curve From 0 to 12 Hours (AUC(0-12)) of Single Dose AZD9773 Serum Total Fabs (Cohorts 1 and 2)|AUC(0-12) for single dose AZD9773 serum total Fabs (cohorts 1 and 2). PK analysis set (ie a subset of the safety analysis set including only those patients without important deviations that could affect the PK).|Day 1 [PK samples taken pre-dose, the end of each infusion rate and then at 0.5, 1, 2, 8, and 12h post-(last) infusion]|Participants analyzed relates to the number of evaluable patients at the specified time point.||μg.h/mL||Full Range|Geometric Mean
759199|NCT00615017|Secondary|Change From Baseline in Sequential Organ Failure Assessment (SOFA) Scores|Change in SOFA (Sequential Organ Failure Assessment) scores from baseline (pre-infusion) to Day 6 [calculated as Day 6 mean minus baseline mean]. The SOFA score is out of a maximum of 24 (units on a scale 0 to 24). The higher the score, the worse the organ system functioning. Safety analysis set (ie all patients who started study drug infusion).|Day 6|Participants analyzed relates to the number of evaluable patients at the specified time point.||units on a scale (0 to 24)||Full Range|Mean
759200|NCT00615017|Secondary|28-Day Mortality|The number of patients who had died at Day 28. Safety analysis set (ie all patients who started study drug infusion).|End of study (Day 28)|||Participants|||Number
759201|NCT00615017|Primary|Change From Baseline in Body Weight|Change in body weight from baseline (pre-infusion) to Day 6 [calculated as Day 6 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).|Day 6|Participants analyzed relates to the number of evaluable patients at the specified time point.||kg||Full Range|Mean
759202|NCT00615017|Primary|Change From Baseline in Calculated Mean Arterial Blood Pressure|Change in calculated mean arterial pressure from baseline (pre-infusion) to Day 14 [calculated as Day 14 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).|Day 14|Participants analyzed relates to the number of evaluable patients at the specified time point.||mmHg||Full Range|Mean
759203|NCT00615017|Primary|Change From Baseline in QT With Fridericia Correction (QTcF), Where QT is Measured by ECG, and is the Time Interval Between the Start of the Q Wave and the End of the T Wave in the Heart's Electrical Cycle.|Change in QTcF from baseline (pre-infusion) to Day 1 (end of infusion) for Cohorts 1 and 2 [calculated as Day 1 mean minus baseline mean] and Day 5 (end of infusion) for Cohorts 3 to 5 and placebo [calculated as Day 5 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).|Day 1 (end of infusion) for Cohorts 1 and 2; Day 5 (end of infusion) for Cohorts 3 to 5 and placebo|Participants analyzed relates to the number of evaluable patients at the specified time point.||msec||Full Range|Mean
759204|NCT00615017|Primary|Change From Baseline in Troponin I|Change in troponin I values from baseline (pre-infusion) to Day 6 [calculated as Day 6 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).|Day 6|Participants analyzed relates to the number of evaluable patients at the specified time point.||μg/L||Full Range|Mean
759205|NCT00615017|Primary|Change From Baseline in Prothrombin Time Values|Change in prothrombin time values from baseline (pre-infusion) to Day 7 [calculated as Day 7 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).|Day 7|Participants analyzed relates to the number of evaluable patients at the specified time point.||sec||Full Range|Mean
759206|NCT00615017|Primary|Change From Baseline in Platelet Count Values|Change in platelet count values from baseline (pre-infusion) to follow-up (28 days after the start of study drug administration) [calculated as Day 28 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).|End of study (Day 28)|Participants analyzed relates to the number of evaluable patients at the specified time point.||10^9/L||Full Range|Mean
759207|NCT00615017|Primary|Change From Baseline in White Blood Cell Values|Change in white blood cell values from baseline (pre-infusion) to follow-up (28 days after the start of study drug administration) [calculated as Day 28 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).|End of study (Day 28)|Participants analyzed relates to the number of evaluable patients at the specified time point.||10^9 cells/L||Full Range|Mean
759208|NCT00615017|Primary|Change From Baseline in Haemoglobin Values|Change in haemoglobin values from baseline (pre-infusion) to follow-up (28 days after the start of study drug administration) [calculated as Day 28 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).|End of study (Day 28)|Participants analyzed relates to the number of evaluable patients at the specified time point.||g/L||Full Range|Mean
759209|NCT00615017|Primary|Change From Baseline in Bilirubin Values|Change in bilirubin values from baseline (pre-infusion) to follow-up (28 days after the start of study drug administration) [calculated as Day 28 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).|End of study (Day 28)|Participants analyzed relates to the number of evaluable patients at the specified time point.||μmol/L||Full Range|Mean
759210|NCT00615017|Primary|Change From Baseline in Aspartate Aminotransferase Values|Change in aspartate aminotransferase values from baseline (pre-infusion) to follow-up (28 days after the start of study drug administration) [calculated as Day 28 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).|End of study (Day 28)|Participants analyzed relates to the number of evaluable patients at the specified time point.||μkat/L||Full Range|Mean
759211|NCT00615017|Primary|Change From Baseline in Alanine Aminotransferase Values|Change in alanine aminotransferase values from baseline (pre-infusion) to follow-up (28 days after the start of study drug administration) [calculated as Day 28 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).|End of study (Day 28)|Participants analyzed relates to the number of evaluable patients at the specified time point.||μkat/L||Full Range|Mean
759212|NCT00615017|Primary|Change From Baseline in Creatinine Values|Change in creatinine values from baseline (pre-infusion) to follow-up (28 days after the start of study drug administration) [calculated as Day 28 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).|End of study (Day 28)|Participants analyzed relates to the number of evaluable patients at the specified time point.||μmol/L||Full Range|Mean
759226|NCT00615108|Primary|Percentage of Patients Achieving Blood Pressure (BP) Control|BP control was defined as diastolic blood pressure/systolic blood pressure DBP/SBP< 90/140 mm-Hg during observation period. BP is measured every four weeks. The observation period is 8 weeks.|01-Dec-2006 to 31-Dec-2008|Subjects include those who took 20mg, 40mg, 80mg and unknown dosage||Percentage of Participants|||Number
759213|NCT00615030|Secondary|Trough FEV1 Assessed After 14 Days of Dosing for All Other Treatment Comparisons|Trough FEV1 was assessed by performing spirometry measurements in the clinic for each treatment period. On the morning and evening of Day 15 trough FEV1 (i.e. mean of measurements performed 23 h 10 min and 23 h 45 min post-dose) were assessed. An analysis of covariance (ANCOVA) model was used with the (period) baseline FEV1 as covariate. The (period) baseline FEV1 was defined as the value measured before the study drug administration in that treatment period.|After 14 days of dosing|The modified intention-to-treat (mITT) population included all randomized patients who received at least one dose of study drug. Patients who received only one treatment were also included for calculation of treatment means.||Liters||Standard Error|Least Squares Mean
759214|NCT00615030|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) Following 14 Days of Evening Dosing of Indacaterol Versus Placebo|"Trough FEV1 was assessed by performing spirometry measurements in the clinic for each treatment period. For the primary efficacy variable, trough FEV1 is the mean of two measurements taken at 23h 10 min and 23h 45 min post dose. The primary variable was analyzed using an analysis of covariance (ANCOVA) model with the (period) baseline FEV1 as covariate.
The (period) baseline FEV1 was defined as the value measured before the study drug administration in that treatment period."|After 14 days of treatment|The modified intention-to-treat (mITT) population included all randomized patients who received at least one dose of study drug. Patients who received only one treatment were also included for calculation of treatment means. This analysis included all patients who received indacaterol in the evening or placebo in their assigned treatment sequence.||Liters||Standard Error|Least Squares Mean
759215|NCT00615056|Secondary|Change From Baseline in MDASI–D Symptom Interference Score at Day 1 of Cycles 2-5, Day 1 of Every Odd-numbered Cycle Throughout the Study and End of Treatment (Cycle 65) or Withdrawal|Symptom Interference score is comprised of the average of 6 items on feeling or function from the MDASI-D core (general activity, mood, work, relations with others, walking, and enjoyment of life) and ranges from 0 to 10. Participants were asked to rate how much symptoms have interfered in last week; each item rated from 0 to 10, with 0 = did not interfere and 10 = interfered completely. Lower scores indicated better outcome. Total average score range: 0 to 10.|Baseline, Day 1 of cycle 2-5, Day 1 of every odd-numbered cycle throughout the study and end of treatment (cycle 65) or withdrawal|ITT population. Here 'N’ (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ is number of participants analyzed at specific time point for each treatment arm respectively.||Units on a Scale||95% Confidence Interval|Mean
759216|NCT00615056|Secondary|Change From Baseline in MD Anderson Symptoms Inventory Diarrhea (MDASI–D) Symptom Severity Score at Day 1 of Cycles 2-5, Day 1 of Every Odd-numbered Cycle Throughout the Study and End of Treatment (Cycle 65) or Withdrawal|Symptom severity score is comprised of average of 14 MDASI-D core items (pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, remembering things, lack of appetite, drowsiness, dry mouth, sadness, vomiting, numbness or tingling and diarrhea) and ranges from 0 to 10. Participants were asked to rate severity of each symptom at their worst in last week; each item rated from 0 to 10, with 0 = symptom not present and 10 = as bad as you can imagine. Lower scores indicated better outcome. Total average score range: 0 to 10.|Baseline, Day 1 of cycles 2- 5, Day 1 of every odd-numbered cycle throughout the study and end of treatment (cycle 65) or withdrawal|ITT population. Here 'N’ (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ is number of participants analyzed at specific time point for each treatment arm respectively.||Units on a Scale||95% Confidence Interval|Mean
759217|NCT00615056|Secondary|Duration of Response (DR)|Time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Baseline until disease progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 130 weeks|DR was calculated for the subgroup of participants from the ITT set, with a confirmed objective tumor response (CR or PR).||Months||95% Confidence Interval|Median
759218|NCT00615056|Secondary|Percentage of Participants With Objective Response (OR)|Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. PR are those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.|Baseline until disease progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 130 weeks|ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or receive a different drug from that to which they were randomized.||Percentage of participants||95% Confidence Interval|Number
759219|NCT00615056|Secondary|Overall Survival (OS)|Time in months from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Baseline until death or up to 1 year after the randomization of last participant|ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or receive a different drug from that to which they were randomized.||Months||95% Confidence Interval|Median
759220|NCT00615056|Primary|Progression Free Survival (PFS)|"Time in months from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Baseline until disease progression or discontinuation from the study due to any cause, assessed every 8 week up to 130 weeks|Intent-to-treat (ITT) population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or receive a different drug from that to which they were randomized.||Months||95% Confidence Interval|Median
759227|NCT00615199|Secondary|Time to First Response 100|Clinical response 100: defined as a reduction in CDAI score from baseline of at least 100 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.|Week 1 through Week 4|FAS population: included all randomized participants who had either withdrawn as treatment failure or completed at least 1 week of dosing and had at least 1 valid CDAI score during the active double-blind phase.||days||95% Confidence Interval|Median
759228|NCT00615199|Secondary|Time to First Response 70|Clinical response 70: defined as a reduction in CDAI score from baseline of at least 70 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 , higher score indicates higher disease activity.|Week 1 through Week 4|FAS population: included all randomized participants who had either withdrawn as treatment failure or completed at least 1 week of dosing and had at least 1 valid CDAI score during the active double-blind phase.||days||95% Confidence Interval|Median
759229|NCT00615199|Secondary|Time to First Clinical Remission|Clinical remission=CDAI <150 points. CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant’s Diary kept while on study. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.|Week 1 through Week 4|FAS population: included all randomized participants who had either withdrawn as treatment failure or completed at least 1 week of dosing and had at least 1 valid CDAI score during the active double-blind phase.||days||95% Confidence Interval|Median
759230|NCT00615199|Secondary|Number of Participants With Clinical Response 100 at Week 4|Clinical response 100: defined as a reduction in CDAI score from baseline of at least 100 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.|Week 4|FAS: all randomized participants who had either withdrawn as treatment failure or completed at least 1 week of dosing and had at least 1 valid CDAI score during the active double-blind phase. Number of participants analyzed excluded those with missing data or who fell outside the visit window.||participants|||Number
759231|NCT00615199|Secondary|Number of Participants Achieving Clinical Remission at Week 4|Clinical remission=CDAI at Week 4 less than (<) 150 points. CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant’s Diary kept while on study. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.|Week 4|FAS: all randomized participants who had either withdrawn as treatment failure or completed at least 1 week of dosing and had at least 1 valid CDAI score during the active double-blind phase. Number of participants analyzed excluded those with missing data or who fell outside the visit window.||participants|||Number
759232|NCT00615199|Secondary|Number of Participants With Clinical Response 70 at Week 1 and 2|Clinical response 70: defined as a reduction in CDAI score from baseline of at least 70 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.|Week 1, 2|FAS: all randomized participants who had either withdrawn as treatment failure or completed at least (>=)1 week of dosing and had >=1 valid CDAI score during active double-blind phase. Number of participants analyzed excluded those with missing data or who fell outside visit window. ‘n’=participants evaluable at given time point for each group.||participants|||Number
759233|NCT00615199|Primary|Number of Participants With Clinical Response 70 at Week 4|Clinical response 70: defined as a reduction in Crohn’s Disease Activity Index (CDAI) score from baseline of at least 70 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.|Week 4|Full Analysis Set (FAS): all randomized participants who had either withdrawn as treatment failure or completed at least 1 week of dosing and had at least 1 valid CDAI score during the active double-blind phase. Number of participants analyzed excluded those with missing data or who fell outside the visit window.||participants|||Number
759234|NCT00615264|Secondary|Change From Baseline in Mixed-meal Stimulated C-peptide AUC at 24 Months|Beta cell function, measured as stimulated C-peptide secretion from 0 to 120 min post administration AUC, at baseline and 24 month measurements in a mixed-meal tolerance test (MMTT). The change in AUC was calculated per patient by subtracting the baseline AUC from the 24 month AUC.|Baseline and 24 Months|Modified Intent to Treat (MITT) Population||nmol*minute/L||Standard Error|Mean
759235|NCT00615264|Primary|Change From Baseline in Glucagon-stimulated C-peptide AUC at 24 Months|Beta-cell function, measured as change in stimulated C-peptide secretion measured 0, 2, 6, 10 and 20 minutes post administration [area under the curve (AUC), 0-20 minutes] at Baseline and 24 months, during a glucagon stimulation test (GST). The change in AUC was calculated per patient by subtracting the baseline AUC from the 24 month AUC.|Baseline and 24 months|Modified Intent to Treat (MITT) Population - all randomized patients who received at least one dose of study medication and who entered the study according to the definition of the target population, as defined by the inclusion and exclusion criteria in the study protocol||nmol*minute/L||Standard Error|Mean
759236|NCT00615290|Secondary|Patient Self Perception of the New Treatment|"Visual analogue scale range from 0 not at all satisfied to 100 extremely satisfied"|Day 0, month 3 and month 6|All enrolled patients||millimeter||Standard Deviation|Mean
759238|NCT00615290|Secondary|Viral Load Response at 3 Months|"Please note that a reported value of 49 copies/mL for the median or first quartile indicates that the observed statistic for the outcome measure is below the limit of quantification for viral load. The limit of quantification is 50 copies/mL."|3 months after inclusion|All enrolled patients with data at 3 months||copies/mL||Inter-Quartile Range|Median
759239|NCT00615290|Secondary|Evaluation of Intermediate Virological Response, Viral Load < 50 Copies/mL|Number of patients with a viral load < 50 copies/mL after 3 months of treatment|3 months after inclusion|All enrolled patients with data at 3 months||participants|||Number
759240|NCT00615290|Secondary|Evaluation of Intermediate Virological Response, Viral Load < 400 Copies/mL|Number of patients with a viral load < 400 copies/mL after 3 months of treatment|3 months after inclusion|All enrolled patients with data at 3 months||participants|||Number
759241|NCT00615290|Secondary|CD4 Count at 1 Month||1 month after inclusion|All enrolled patients with data at 1 month||cells/cubic millimeter||Inter-Quartile Range|Median
759242|NCT00615290|Secondary|Viral Load Response at 1 Month|"Please note that a reported value of 49 copies/mL for the median or first quartile indicates that the observed statistic for the outcome measure is below the limit of quantification for viral load. The limit of quantification is 50 copies/mL."|1 month after inclusion|All enrolled patients with data at 1 month||copies/mL||Inter-Quartile Range|Median
759243|NCT00615290|Secondary|Evaluation of Early Virological Response|Number of patients presenting a decrease of viral load (HIV-RNA copies per mL) from day 0 to month 1 higher than 1 log10|1 month after inclusion|All enrolled patients with data at 1 month||participants|||Number
759244|NCT00615290|Primary|Number of Patients With a Viral Load< 50 Copies/mL and a Gain in CD4 Higher Than 100 Cells/mm3|The evaluation at month 6 of an immunovirological response defined by a viral load less than 50 copies/mL and a gain in CD4 between day 0 and month 6 higher than 100 cells/mm3|6 months after inclusion|All enrolled patients with data at 6 months||participants|||Number
759245|NCT00615433|Secondary|CGI-S (Clinical Global Impression - Severity) Change From Baseline to the End of the Double-blind Treatment.|The CGI-S is a clinician-rated assessment of the subject’s current illness state on a 7-point scale, where a higher score is associated with greater illness severity.|6 weeks|The primary population for the efficacy analysis was the Intent-to-Treat (ITT) population. All subjects who were randomized, received at least one dose of study medication, and have a Baseline efficacy measurement and at least one post-Baseline efficacy measurement, were in the efficacy analysis in the treatment group to which they were randomized.||scale||95% Confidence Interval|Least Squares Mean
759246|NCT00615433|Primary|Change in Total PANSS (Positive and Negative Syndrome Scale)Score From Baseline to the End of the Double Blind Treatment Period.|The PANSS is a 30-item rating instrument evaluating the presence/absence and severity of positive, negative and general psychopathology of schizophrenia. The scale was developed from the BPRS and the Psychopathology Rating Scale. All 30 items are rated on a 7-point scale (1=absent; 7=extreme). The total score can range from 30 to 210. Lower scores represent less severity of illness.|Baseline and 6 weeks|The primary population for the efficacy analysis was the Intent-to-Treat (ITT) population. All subjects who were randomized, received at least one dose of study medication, and have a Baseline efficacy measurement and at least one post-Baseline efficacy measurement, were in the efficacy analysis in the treatment group to which they were randomized.||Units on a scale||95% Confidence Interval|Least Squares Mean
759247|NCT00615459|Secondary|Peak FEV1 During 4 Hours Post Morning Dose on Day 1|FEV1 was measured with spirometry conducted according to internationally accepted standards. The peak effect on Day 1 was defined as the maximum FEV1 during the first 4 hour on that day. FEV1 measurements taken within 6 hour of rescue use were set to missing before the peak FEV1 (0-4 hour) was calculated. The model used for analysis contained the (period) baseline FEV1 as covariate. The (period) baseline FEV1 was defined as the value measured before the study drug administration in that treatment period.|Day 1 (from 0 to 4 hours post morning dose)|The modified intent-to-treat (mITT) population, included all randomized patients who received at least one dose of study drug.||Liters||Standard Error|Least Squares Mean
759248|NCT00615459|Primary|24-hour Post-dose Trough Forced Expiratory Volume in 1 Second (FEV1) After 14 Days of Treatment|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the mean of FEV1 measurements at 23 h 10 min and 23 h 45 min post Day 14 dose measured on the morning of Day 15 in each treatment period. The model used for analysis contained the (period) baseline FEV1 as covariate. The (period) baseline FEV1 was defined as the value measured before the study drug administration in that treatment period.|23 hours 10 minutes and 23 hours 45 minutes post-dose on Day 15 of each treatment period|The modified intent-to-treat (mITT) population, included all randomized patients who received at least one dose of study drug. Patients were analyzed according to treatment they received.||Liters||Standard Error|Least Squares Mean
759249|NCT00615472|Primary|Number of Participants With Improved Postoperative Delirium and Cognitive and Motor Changes|A battery/Questionnaire of neuropsych examinations is given to the subjects to measure improvement based on change of scores and standard deviation. The battery consists of questions regarding delirium, cognitive and motor changes and yields a combination assessment of all 3 elements.|Four months|||participants|||Number
759250|NCT00615550|Secondary|Number of Infants With a Birth Weight < 1500 Grams or < 2500 Grams|Assessment of birth weight < 1500 grams or < 2500 grams|date of delivery|Available birth weight.||participants|||Number
759251|NCT00615550|Secondary|Number of Neonates Who Died.||Delivery to 28 days|All infants with a known delivery date and status.||participants|||Number
759252|NCT00615550|Secondary|Number of Subjects With Preterm Birth at ≤27 6/7, ≤34 6/7, and <36 6/7 Weeks Gestation.|Number of participants at <=27 6/7 , <=34 6/7, and <36 6/7.|Gestational Age at Delivery|Intent to Treat||participants|||Number
759253|NCT00615550|Secondary|Number of Infants With Neonatal Morbidities Such as Respiratory Distress Syndrome (RDS), Bronchopulmonary Dysplasia (BPD), Intraventricular Hemorrhage (IVH), Proven Sepsis, and Necrotizing Enterocolitis (NEC)|"Each infant is scored based on the 7 morbidity and mortality events above:
0= no morbidity event
1 morbidity event
2 morbidity events
3 or more morbidity events
mortality"|Delivery Hospitalization (1-212 days)|||participants|||Number
759254|NCT00615550|Primary|Number of Participants With Birth <=32 6/7 Weeks Gestation.||9 to 13 weeks|Intent to Treat||participants|||Number
760485|NCT00626574|Secondary|To Determine if Administration of Procrit® Prior to Aneurysm Clipping Reduces the Incidence of Vasospasm Following a SAH Event Treated by Vascular Clipping.||first 10 days following clipping and 6 week f/u||||||
759255|NCT00615589|Secondary|Non Relapse Mortality (NRM) at 1 Year and 3 yearsThe Percentage of Deaths Not Attributable to Disease Relapse or Progression|Non relapse mortality, defined as the percentage of deaths not attributable to disease relapse or progression at 1 year and at 3 years.|3 years|||percentage of deaths||95% Confidence Interval|Number
759256|NCT00615589|Secondary|Percentage of Patients With Acute and Chronic Graft Versus Host Disease (GVHD)|"Incidence of acute (Stage II-IV and Stage III-IV) and chronic GVHD (any stage) were analyzed.
Acute GVHD Grading:
Stage II - Skin, 25-50% BSA (Body Surface Area); Liver, 3.1-6mg/dl bilirubin; Gut, 1000-1500ml/day diarrhea Stage III - Skin, generalized erythroderma; Liver, 6.1-15mg/dl bilirubin; Gut, >1500ml/day diarrhea Stage IV - Skin, bullae; Liver, >15mg/dl bilirubin; Gut, pain +/- ileus"|100 days, 2 years|||percentage of participants||95% Confidence Interval|Number
759257|NCT00615589|Secondary|Percentage of Patients With Treatment Related Mortality (TRM)||100 days, one-year|||percentage of patients||95% Confidence Interval|Number
759258|NCT00615589|Secondary|The Percentage of Patients Free From Progression at 1 Year|"One of the secondary outcomes that will be measured is progression free survival at 1 Year.
Progressive Disease (PD) is defined as a >25% increase in serum monoclonal paraprotein, a >25% increase in 24-hour urinary light chain excretion, a >25% increase in plasma cells in bone marrow aspirate, an increase in the size or the development of new bone lesions/soft tissue plasmacytomas, or the development of hypercalcemia."|1 Year|||percentage of patients||95% Confidence Interval|Number
759259|NCT00615589|Primary|The Percentage of Patients Alive 1 Year Post Transplant|The primary objective is overall survival, one year from the time of transplant.|1 Year|||percentage of patients||95% Confidence Interval|Number
759260|NCT00621023|Secondary|Number of Patients With an Unacceptable Toxicity|Any of the following non-hematologic toxicities that causes a patient's therapy to be suspended or discontinued: Creatinine > 2x baseline value; serum glutamate oxaloacetate transaminase (SGOT), serum glutamate pyruvate transaminase (SGPT), Total bilirubin > 2x the upper limit of normal; Febrile neutropenia; Uncontrolled infection; Hepatotoxicity defined as an increase in serum bilirubin, SGOT, or alkaline phosphatase to >5 times baseline value); nephrotoxicity (defined as serum creatinine >3.5 times the ULN); neurological impairment (defined as somnolence, seizures, or impaired mentation); severe peripheral neuropathy, or any non-hematologic grade 4 toxic event.|During the treatment period and for 30 days after last dose of study drug|||participants|||Number
759261|NCT00621023|Secondary|Duration of a Complete or Partial Response Based on Number of People Who Responded.|Number of months a complete or partial response was maintained.|Up to 5 years or until death||||||
759262|NCT00621023|Primary|Number of Patients With an Overall Response of Complete Response (CR) or Partial Response (PR)|Complete response and Partial response are defined using 2000 international working group (IWG) criteria. The Primary criteria for a CR is a repeat bone marrow showing < 5% myeloblasts with normal maturation of all cell lines, with no evidence for dysplasia . A PR meets all the CR criteria except Blasts decreased by >50% over pretreatment, or a less advanced myelodysplastic syndrome (MDS) French American British (FAB) classification than pretreatment.|after 4 cycles of therapy|||participants|||Number
759263|NCT00621049|Secondary|Overall Survival (OS)|The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death|18 months|||months||95% Confidence Interval|Median
759264|NCT00621049|Secondary|2-year Survival|Proportion of patients known to still be alive 2 years after coming on study|24 months|||percentage of participants|||Number
759265|NCT00621049|Secondary|Safety|Adverse Events occuring in >15% of patients|2 years|||participants|||Number
759266|NCT00621049|Primary|Disease-free Survival|The length of time, in months, that patients were alive from the end of their treatment without any signs or symptoms of their disease.|1 year|||months||95% Confidence Interval|Median
759267|NCT00621140|Secondary|Adjusted Means for 2h Post Prandial Blood Glucose (PPG) Change From Baseline at Week 24|This change from baseline reflects the Week 24 2h PPG minus the baseline 2h PPG. Means are treatment adjusted for baseline HbA1c, baseline PPG and previous anti-diabetic medication.|Baseline and week 24|Meal Tolerance Test (MTT) set (patients with adequate MTT results available at the beginning and end of the randomised treatment period)||mg/dL||Standard Error|Mean
759268|NCT00621140|Secondary|Percentage of Patients With HbA1c Lowering by 0.5% at Week 24|The percentage of patients with an HbA1c reduction from baseline >= 0.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c reduction less than 0.5%.|Baseline and week 24|The Full Analysis Set (FAS) included all patients with a baseline and at least one on treatment HbA1c measurement available. Non-completers were considered as failure imputation (NCF).||percentage of patients|||Number
759269|NCT00621140|Secondary|Percentage of Patients With HbA1c<6.5% at Week 24|The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c >= 6.5%.|Baseline and week 24|This population includes the Full Analysis Set (FAS). Non-completers were considered as failure imputation (NCF).||Percentage of Patients|||Number
759270|NCT00621140|Secondary|Percentage of Patients With HbA1c <6.5% at Week 24|The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c >= 6.5%. Only patients with baseline HbA1c >= 6.5%.|Baseline and week 24|This population includes the FAS with baseline HbA1c >= 6.5%. Non-completers were considered as failure imputation (NCF).||percentage of patients|||Number
759271|NCT00621140|Secondary|Percentage of Patients With HbA1c<7.0% at Week 24|The percentage of patients with an HbA1c value below 7.0% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c >= 7.0%.|Baseline and week 24|This population includes the Full Analysis Set (FAS). Non-completers were considered as failure imputation (NCF).||percentage of patients|||Number
759272|NCT00621140|Secondary|Percentage of Patients With HbA1c <7.0% at Week 24|The percentage of patients with an HbA1c value below 7.0% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c >= 7.0%. Only patients with baseline HbA1c >= 7%|Baseline and week 24|This population includes the FAS with baseline HbA1c >= 7.0%. Non-completers were considered as failure imputation (NCF).||percentage of patients|||Number
772073|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 3|Subject Satisfaction - ease of locating the deflation touch pads|6 months post-surgery|||% satisfactory or somewhat satisfactory|||Number
759273|NCT00621140|Secondary|FPG Change From Baseline at Week 18|This change from baseline reflects the Week 18 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 18|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.||mg/dL||Standard Error|Mean
759274|NCT00621140|Secondary|FPG Change From Baseline at Week 12|This change from baseline reflects the Week 12 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 12|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.||mg/dL||Standard Error|Mean
759275|NCT00621140|Secondary|FPG Change From Baseline at Week 6|This change from baseline reflects the Week 6 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 6|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.||mg/dL||Standard Error|Mean
759276|NCT00621140|Secondary|FPG Change From Baseline at Week 24|This change from baseline reflects the Week 24 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 24|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.||mg/dL||Standard Error|Mean
759277|NCT00621140|Secondary|HbA1c Change From Baseline at Week 18|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 18|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||Percent||Standard Error|Mean
759278|NCT00621140|Secondary|HbA1c Change From Baseline at Week 12|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 12|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||Percent||Standard Error|Mean
759279|NCT00621140|Secondary|HbA1c Change From Baseline at Week 6|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 6 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 6|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||Percent||Standard Error|Mean
759280|NCT00621140|Primary|HbA1c Change From Baseline at Week 24|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 24|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||Percent||Standard Error|Mean
759281|NCT00621153|Secondary|Compliance Levels at 4 Weeks and 8 Weeks of Therapy|Percent of the number of returened pills to the number of prescrited pills|8 weeks||||||
759282|NCT00621153|Secondary|Occurrence of Adverse Events (AE) and Discontinuation of Study Medication Due to AE’s From Baseline (Randomisation) to the End of the Study (8 Weeks)|Occurred number of AE and disconinuation of study medication due to the AE from basline after 8 weeks|8 weeks||||||
759283|NCT00621153|Secondary|Changes in Hs-CRP Level From Baseline After 8 Weeks of Therapy|Change of hs-CRP from basline after 8 weeks|8 weeks||||||
759284|NCT00621153|Secondary|Changes in Mean Sitting SBP From Baseline After 8 Weeks of Therapy|Changed SBP from baseline after 8 weeks|8 weeks||||||
759285|NCT00621153|Secondary|Proportion of Patients Achieving Goal of Mean Trough Sitting DBP (<90 mmHg, But <80 mmHg for DM & Chronic Kidney Disease) and SBP (<140 mmHg, But <130 mmHg for DM & Chronic Kidney Disease) After 8 Weeks of Therapy|Percent of patients achieving goal of DBP|8 weeks||||||
759286|NCT00621153|Secondary|Proportion of Patients Achieving Goal of Mean Trough Sitting DBP (<90 mmHg, But <80 mmHg for DM & Chronic Kidney Disease) and SBP (<140 mmHg, But <130 mmHg for DM & Chronic Kidney Disease) After 4 Weeks of Therapy|Percent of the patients achieving goal DBP and SBP after 4 weeks|4 weeks||||||
759287|NCT00621153|Secondary|Changes in Mean Sitting SBP From Baseline After 4 Weeks of Therapy|Mean of the changed SBP from baseline after 4 weeks|4 weeks||||||
759288|NCT00621153|Primary|Changes in Mean Sitting DBP From Baseline After 4 Weeks of Therapy|Mean of the changed DBP from baseline after 4 weeks|4 weeks|||mmHg||Standard Deviation|Least Squares Mean
759289|NCT00621192|Primary|Key Safety Endpoints|Safety assessments included death, seizure documentation (including correlation of serum meropenem level and seizures), strictures, perforation, wound dehiscence, short gut, development of extended beta lactamase infection, development of candidiasis, antimicrobial therapy failure|Up to 51 days (Adverse Events (AEs) were recorded from the time of informed consent until 72 hours following the last dose of study drug)|Safety Population - The Safety Population includes all patients who receive any amount of meropenem.||Participants|||Number
759290|NCT00621192|Primary|Meropenem Clearance|Given the limited availability of blood for Pharmacokinetic (PK) assessments in this population a sparse sampling approach was utilized. Subjects were assigned to one of two Dose 1 sample collection schedules, “PK-odd” and “PK-even” based on birth date to ensure collection of PK data throughout the dose interval. In addition, PK samples were collected around approximately the 5th dose. Subjects that did not have Dose 1 PK samples could have steady-state (Dose 5) using the Dose 5 PK collection schedule.|Up to 7-8hrs post drug administration|||L/h/kg||Standard Deviation|Mean
759291|NCT00621192|Primary|Deaths||Up to 51 days (Recorded from the time of informed consent until 72 hours following the last dose of study drug)|The Safety Population includes all patients who receive any amount of meropenem.||Participants|||Number
764971|NCT00673075|Secondary|Proportion of Patients With Peripheral SBP <140 mm Hg and DBP <90 mm Hg at Week 18|Proportion of Patients with Peripheral SBP <140 mm Hg and DBP <90 mm Hg at Week 18|18 weeks post-treatment|||participants|||Number
759292|NCT00621192|Primary|Efficacy Success (Alive at Efficacy Visit,Last Culture (if Obtained) From Sterile Body Fluid is Negative for Bacteria (Except Staphylococcus Species) From Start of Study Drug Until Efficacy Visit,Presumptive Clinical Cure Score(PCCS) >7 at Efficacy Visit)|"The PCCS was derived by comparing clinical signs and symptoms prior to administration of the first dose of study drug and study Day 28.The elements of the PCCS include Mean BP,Temp,PaO2(mmHg)/FiO2,Lowest serum pH,seizures,Urine output,Cardiovascular inotrope support,C-reactive protein (CRP)and Abdominal girth.
Score - Asymptomatic to Asymptomatic 1;Asymptomatic to Worsening 0;Symptomatic to Worsening 0;Symptomatic to No change 0;Symptomatic to Improved 1;Symptomatic to Asymptomatic 1
If 7 or more of 10 signs received a score of 1, then the infant was considered a presumptive clinical cure.
GA stands for Gestational Age and PNA stands for Postnatal Age."|Average of 12 days (3 to 21 days)|The Efficacy Population includes all patients who have efficacy assessment (Clinical Signs) at Pre-Dose and Study Day 28 (or the day that the Day 28 assessments were taken).||Participants|||Number
759293|NCT00621244|Secondary|Highest Percent Change of Fetal Hemoglobin From Baseline in Arm 2 (MWF Every Other Week)|All blood samples were drawn immediately prior to each administration of LBH589 dose and at the end of treatment (≤ 7 days post last dose (preferably ≥ 4 days [96 hours]))|Post dose to pre-dose (up to 3.5 years)|Full Analysis Set (with available samples for analysis)||Percent Change||Standard Deviation|Mean
759294|NCT00621244|Secondary|Highest Percent Change in Fetal Hemoglobin From Baseline in Arm 1 (MWF Every Week)|All blood samples were drawn immediately prior to each administration of LBH589 dose and at the end of treatment (≤ 7 days post last dose (preferably ≥ 4 days [96 hours]))|Post dose to pre-dose (up to 3.5 years)|Full Analysis Set (with available samples for analysis)||Percent Change||Standard Deviation|Mean
759295|NCT00621244|Secondary|Percentage of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group Y||Days 5, 8, 10, 12, 15, End of study (up to 3.5 years)|Full Analysis Set||Percentages of participants|||Number
759296|NCT00621244|Secondary|Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group X||Days 5, 8, 10, 12, 15, End of study, Unscheduled (up to 3.5 years)|Full Analysis Set||Percentages of participants|||Number
759297|NCT00621244|Secondary|Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group Y||Days 5, 8, end of study (up to 3.5 years)|Full Analysis Set||Percentages of participants|||Number
759298|NCT00621244|Secondary|Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group X|Reporting the number of patients with a reading at the timepoint in the dose group.|Days 1, 5, 8, 10, 15|Full Analysis Set N=number of participants analyzed. total n=number of patients with a reading at the timepoint in the dose group.||Percentages of participants|||Number
759299|NCT00621244|Secondary|Geometric Mean Ratio (GMR) Comparing Treatment Days in Arm 1|MWF Every week schedule n = number of subjects with non-missing values.|Day 15/day 1|Pharmacokinetic set||Ratio||90% Confidence Interval|Geometric Mean
759300|NCT00621244|Secondary|Half Life of Panobinostat After Multiple Doses in Arm 1 on Day 15||Day 15|Pharmacokinetic set||hour||Standard Deviation|Mean
759301|NCT00621244|Secondary|Maximum Plasma Concentration of Panobinostat After Multiple Doses in Arm 1 on Day 15|From day 15 by dose with schedule: MWF every week|Day 15|Pharmacokinetic set||ng/mL||Standard Deviation|Mean
759302|NCT00621244|Secondary|Half Life of Panobinostat After the First Dose in Arms 1 and 2||Day 1|Pharmacokinetic set||hour||Standard Deviation|Mean
759303|NCT00621244|Secondary|Maximum Plasma Concentration of Panobinostat After the First Dose in Arms 1 and 2||Day 1|Pharmacokinetic set: Pharmacokinetic population consisted of all patients who provided at least one postdose PK plasma sample.||ng/mL||Standard Deviation|Mean
759304|NCT00621244|Secondary|Response as Per Investigator Assessment for Patients With Myelodysplastic Syndromes (MDS)|Response as per investigator assessment for patients include complete response, stable disease, progressive disease/failure, partial remission.|3.5 years|Full Analysis Set||Participants|||Number
759305|NCT00621244|Secondary|Response as Per Investigator Assessment for Patients With Hodgkin’s Lymphoma (HD)|Response as per investigator assessment for patients include complete response, partial remission, stable disease, progressive disease (PD)/failure.|3.5 years|Full Analysis Set||Participants|||Number
759306|NCT00621244|Secondary|Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML) in Expansion Phase|Stage 2 did not open for enrollment.|1.2 years|Full Analysis Set. Response as per investigator assessment for a subset of patients with AML accrued in the expansion phase (IA) include complete response, progressive disease/failure, stable disease.||Participants|||Number
759307|NCT00621244|Secondary|Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML)|Response as per investigator assessment for patients include complete response, progressive disease/failure, stable disease.|3.5 years|Full Analysis Set: defined according to the Intention to Treat (ITT) principle. This population set included all patients to whom study treatment had been assigned.||Participants|||Number
759308|NCT00621244|Primary|Number of Participants DLT in Arm 2 in Dose Escalation Phase|"Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) for intermittent dosing schedule (MWF weekly).
A 3-parameter version of a Bayesian logistic regression model with overdose control (Babb, Rogatko, and Zacks 1998) was used during the dose escalation phase for dose level selection and determination of the MTD."|Cycle 1 (28-day treamtent cycle)|MTD-determining population: All patients from the safety population who were in the dose escalation phase of the study, and who received panobinostat for ≥ 9 full doses in arm 1 during cycle 1 and completed all required safety evaluations; or who received panobinostat.||Participants|||Number
759309|NCT00621244|Primary|Number of Participants DLT in Arm 1 in Dose Escalation Phase|Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) for consecutive dosing schedule (MWF weekly). A 3-parameter version of a Bayesian logistic regression model with overdose control (Babb, Rogatko, and Zacks 1998) was used during the dose escalation phase for dose level selection and determination of the MTD.|Cycle 1 (28-day treatment cycle)|MTD-determining set: Patients in the safety set who were in the dose escalation phase, and who received panobinostat for ≥ 9 full doses in arm 1 in cycle 1 and completed all needed safety evaluations; or who received panobinostat for ≥ 5 full doses in arm 2 in cycle 1 and completed all required safety evaluations; or who experienced DLT in cycle 1.||Participants|||Number
764972|NCT00673075|Secondary|Peripheral Systolic Blood Pressure (SBP)|Peripheral systolic blood pressure (SBP) at visit 13 (week 18)|18 weeks post initiation of randomized treatment|||mmHg||Standard Error|Mean
759310|NCT00621257|Secondary|Maintenance of 25 Hydroxy Vitamin D Levels in Pediatric Patients With Inflammatory Bowel Disease|Percentage of pediatric patients with inflammatory bowel disease who maintained their serum 25OHD level at or above 32 ng/mL at all study visits over the duration of the maintenance study 25OHD is the most abundant vitamin D metabolite, which is bound to vitamin D binding protein. The measurement of its concentration in serum, reflects vitamin D stores. Concentration at or above 32 ng/mL has been identified as optimal vitamin D level for bone health by majority of experts.|12 months|||Participants|||Count of Participants
759311|NCT00621257|Primary|Treatment of Low 25 Hydroxy Vitamin D Levels in Pediatric Patients With Inflammatory Bowel Disease|"Change in serum 25OHD levels after treatment with vitamin D formulations for 6 weeks in pediatric patients with inflammatory bowel disease.
25OHD is the most abundant vitamin D metabolite, which is bound to vitamin D binding protein. The measurement of its concentration in serum, reflects vitamin D stores."|6 weeks|||ng/ml||Standard Deviation|Mean
759312|NCT00621296|Primary|Undetectable HCV RNA at 24 Weeks After Completion of Drug Administration||24 Weeks After Completion of Drug Administration (dosing period is 24 Weeks) or drug withdrawal. The subjects were assessed at 24 weeks following the last dose of study drug.|||participants|||Number
759313|NCT00621322|Secondary|Anti-M72 Specific Antibody Concentrations|Concentrations given in enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) were expressed as geometric mean concentrations (GMCs).|At Day 0, 30, 60 and 210|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
759314|NCT00621322|Secondary|Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule|"Expressed cytokine combinations for CD4+ T cells were CD40-L and IL-2 or IFN-γ or TNF-α; IL-2 and CD40-L, or IFN-γ, or TNF-α; IFN-γ and CD40-L, or IL-2, or TNF-α; TNF-α and CD40-L, or IL-2, or IFN-γ.
For CD8+ T cells no vaccine induced responses were observed, thus results are presented only for the frequency of M72-specific CD8+ T cells expressing at least two cytokines."|At Day 0, 30, 60 and 210|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.||T cells/million cells||Inter-Quartile Range|Median
759315|NCT00621322|Secondary|Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines|Among cytokines expressed were interleukin-2 [IL-2] and/or interferon-gamma [IFN-γ] and/or tumour necrosis factor-alpha [TNF-α] and/or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry, using intracellular cytokine staining (ICS).|At Day 0, 30, 60 and 210|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.||T cells/million cells||Inter-Quartile Range|Median
759316|NCT00621322|Primary|Number of Subjects With Different Biochemical and Haematological Levels|Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CREA], eosinophils [EOS], haematocrit [Hct], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were- normal, below and above.|At Day 60|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.||Subjects|||Number
759317|NCT00621322|Primary|Number of Subjects With Different Biochemical and Haematological Levels|Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CREA], eosinophils [EOS], haematocrit [Hct], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were- normal, below and above.|At Day 37|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.||Subjects|||Number
759318|NCT00621322|Primary|Number of Subjects With Different Biochemical and Haematological Levels|Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CREA], eosinophils [EOS], haematocrit [Hct], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were- normal, below and above.|At Day 30|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.||Subjects|||Number
759319|NCT00621322|Primary|Number of Subjects With Different Biochemical and Haematological Levels|Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CREA], eosinophils [EOS], haematocrit [Hct], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were- normal, below and above.|At Day 7|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.||Subjects|||Number
759320|NCT00621322|Primary|Number of Subjects With Different Biochemical and Haematological Levels|Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CREA], eosinophils [EOS], haematocrit [Hct], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were- normal, below and above.|At Day 0|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.||Subjects|||Number
759321|NCT00621322|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Day 0 up to Day 210)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.||Subjects|||Number
759322|NCT00621322|Primary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 30-day (Days 0-29) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.||Subjects|||Number
759323|NCT00621322|Primary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms included fatigue, temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastrointestinal symptoms (gastro) [nausea, vomiting, diarrhoea and/or abdominal pain], headache, malaise and myalgia. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day (Days 0-6) post-vaccination period, following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.||Subjects|||Number
759324|NCT00621322|Primary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms included pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. Relationship analysis was not performed.|During the 7-day (Days 0-6) post-vaccination period, following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.||Subjects|||Number
759325|NCT00621348|Secondary|Incidence of Symptomatic Hypernatremia|Symptomatic hypernatremia is defined as serum sodium > 150 mmol/L and the presence of symptoms like altered sensorium, seizure, headache and vomiting not explained otherwise.|72 hrs|Intention to Treat analysis||participants|||Number
759326|NCT00621348|Secondary|Incidence of Symptomatic Hyponatremia|Defined as Hyponatremia (serum sodium < 130 mnol/L)and presence of symptoms attributed to hyponatremia such as altered sensorium, seizure, headache, and vomiting which can not be explained otherwise.|72 hrs|||participants|||Number
759327|NCT00621348|Secondary|Incidence of Hypernatremia (Serum Sodium >150 mmol/L)||72 hrs|Intention To Treat analysis||participants|||Number
759328|NCT00621348|Primary|Incidence of Hyponatremia (Defined as Serum Sodium Less Than 130 mmol/L)||72 hrs|432 patients were eligible. 203 patients were excluded and 62 patients declined consent . Out of 167 patients, 58 patients were randomized to Arm 1, 53 to arm 2 and 56 to arm 3.Intention to treat analysis was used.||participants|||Number
759329|NCT00622284|Secondary|Change in Baseline Lipid Parameter Triglyceride at Week 104||Baseline and week 104|This population includes the treated set (all patients treated with at least one dose of study drug), and non-missing laboratory data.||mg/dL||Standard Deviation|Mean
759330|NCT00622284|Secondary|Change in Baseline Lipid Parameter Low Density Lipoprotein (LDL) at Week 104||Baseline and week 104|This population includes the treated set (all patients treated with at least one dose of study drug), and non-missing laboratory data.||mg/dL||Standard Deviation|Mean
759331|NCT00622284|Secondary|Change in Baseline Lipid Parameter HDL at Week 104||Baseline and week 104|This population includes the treated set (all patients treated with at least one dose of study drug), and non-missing laboratory data.||mg/dl||Standard Deviation|Mean
759332|NCT00622284|Secondary|Change in Baseline Lipid Parameter Cholesterol at Week 104||Baseline and week 104|This population includes the treated set (all patients treated with at least one dose of study drug), and non-missing laboratory data.||mg/dL||Standard Deviation|Mean
759333|NCT00622284|Secondary|HbA1c Change at Week 104|The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement available during the first phase of the study. Last observation carried forward (LOCF) was used as imputation rule.|Baseline and week 104|The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.||Percent||Standard Deviation|Mean
759334|NCT00622284|Secondary|HbA1c Change at Week 91||Baseline and week 91|The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.||Percent||Standard Deviation|Mean
759335|NCT00622284|Secondary|HbA1c Change at Week 78||Baseline and week 78|The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.||Percent||Standard Deviation|Mean
759336|NCT00622284|Secondary|HbA1c Change at Week 65||Baseline and week 65|The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.||Percent||Standard Deviation|Mean
759337|NCT00622284|Secondary|HbA1c Change at Week 52||Baseline and week 52|The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.||Percent||Standard Deviation|Mean
759338|NCT00622284|Secondary|HbA1c Change at Week 40||Baseline and week 40|The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.||Percent||Standard Deviation|Mean
759339|NCT00622284|Secondary|HbA1c Change at Week 28||Baseline and week 28|The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.||Percent||Standard Deviation|Mean
759340|NCT00622284|Secondary|HbA1c Change at Week 16||Baseline and week 16|The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.||Percent||Standard Deviation|Mean
759341|NCT00622284|Secondary|HbA1c Change at Week 12||Baseline and week 12|The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.||Percent||Standard Deviation|Mean
759342|NCT00622284|Secondary|HbA1c Change at Week 8||Baseline and week 8|The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.||Percent||Standard Deviation|Mean
759343|NCT00622284|Secondary|HbA1c Change at Week 4|Difference of base percent value [Week x(%) - baseline (%)]|Baseline and week 4|The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.||Percent||Standard Deviation|Mean
759344|NCT00622284|Secondary|2 hr Postprandial Glucose (PPG) Change From Baseline at Week 104|This change from baseline reflects the Week 104 2 hr PPG minus the Baseline 2hr PPG. Means are treatment adjusted for baseline HbA1c, baseline 2hr PPG and number of previous anti-diabetic medications.|Baseline and week 104|Patients in the FAS with a valid meal tolerance test (MTT) at baseline and at least one valid on-treatment MTT (MTT104).||mg/dL||Standard Error|Mean
759345|NCT00622284|Secondary|Percentage of Patients With HbA1c Lowering by 0.5% at Week 104|Occurrence of relative efficacy response, defined as a lowering of 0.5% HbA1c at week 104|Week 104|FAS (NCF)||Percentage of patients|||Number
759346|NCT00622284|Secondary|Percentage of Patients With HbA1c <6.5% at Week 104|The percentage of patients with an HbA1c value below 6.5% at week 104, based upon patients with baseline HbA1c >= 6.5%. If a patient did not have an HbA1c value at week 104 they were considered a failure, so HbA1c >= 6.5%. The logistic regression is treatment adjusted for baseline HbA1c and number of previous anti-diabetic medications.|Week 104|Full analysis set (FAS) patients with non-completers considered as failures (i.e., non-responders) (NCF) and with baseline HbA1c >=6.5%.||Percentage of patients|||Number
759347|NCT00622284|Secondary|Percentage of Patients With HbA1c <6.5% at Week 52|The percentage of patients with an HbA1c value below 6.5% at week 52, based upon patients with baseline HbA1c >= 6.5%. If a patient did not have an HbA1c value at week 52 they were considered a failure, so HbA1c >= 6.5%. The logistic regression is treatment adjusted for baseline HbA1c and number of previous anti-diabetic medications.|Week 52|Full analysis set (FAS) patients with non-completers considered as failures (i.e., non-responders) (NCF) and with baseline HbA1c >=6.5%.||Percentage of patients|||Number
759348|NCT00622284|Secondary|Percentage of Patients With HbA1c <7.0% at Week 104|The percentage of patients with an HbA1c value below 7.0% at week 104, based upon patients with baseline HbA1c >= 7%. If a patient did not have an HbA1c value at week 104 they were considered a failure, so HbA1c >= 7.0%. The logistic regression is treatment adjusted for baseline HbA1c and number of previous anti-diabetic medications.|Week 104|Full analysis set (FAS) patients with non-completers considered as failures (i.e., non-responders) (NCF) and with baseline HbA1c >=7.0%.||Percentage of patients|||Number
759349|NCT00622284|Secondary|Percentage of Patients With HbA1c <7.0% at Week 52|The percentage of patients with an HbA1c value below 7.0% at week 52, based upon patients with baseline HbA1c >= 7%. If a patient did not have an HbA1c value at week 52 they were considered a failure, so HbA1c >= 7.0%. The logistic regression is treatment adjusted for baseline HbA1c and number of previous anti-diabetic medications.|Week 52|Full analysis set (FAS) patients with non-completers considered as failures (i.e., non-responders) (NCF) and with baseline HbA1c >=7.0%.||Percentage of patients|||Number
759350|NCT00622284|Secondary|Fasting Plasma Glucose (FPG) Change From Baseline at Week 104|This change from baseline reflects the Week 104 FPG minus the Baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and number of previous anti-diabetic medications.|Baseline and week 104|This population includes the FAS further restricted to patients with a baseline FPG and one on-treatment FPG measurement. Last observation carried forward (LOCF) was used as imputation rule.||mg/dL||Standard Error|Mean
759351|NCT00622284|Secondary|Fasting Plasma Glucose (FPG) Change From Baseline at Week 52|This change from baseline reflects the Week 52 FPG minus the Baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and the number of previous anti-diabetic medications.|Baseline and week 52|This population includes the FAS further restricted to patients with a baseline FPG and one on-treatment FPG measurement. Last observation carried forward (LOCF) was used as imputation rule.||mg/dL||Standard Error|Mean
759352|NCT00622284|Secondary|Incidence of Hypoglycaemic Events up to 104 Weeks|A hypoglycaemic event is defined as patient showing clinical signs suggestive of low blood glucose confirmed by a HBGM of below 55 mg/dl (3.1 mmol/L)|Week 104|The treated set consisted of all patients treated with at least one dose of study drug||Patients|||Number
759353|NCT00622284|Secondary|Incidence of Hypoglycaemic Events up to 52 Weeks|A hypoglycaemic event is defined as patient showing clinical signs suggestive of low blood glucose confirmed by a home blood glucose monitoring (HBGM) of below 55 mg/dl (3.1 mmol/L)|Week 52|The treated set consisted of all patients treated with at least one dose of study drug||Patients|||Number
759354|NCT00622284|Secondary|Body Weight Change From Baseline at Week 104|This key secondary endpoint, change from baseline, reflects the Week 104 body weight minus the baseline body weight. Means are treatment adjusted for baseline HbA1c, baseline weight and the number of previous antidiabetic-medications.|Baseline and week 104|This population includes the FAS further restricted to patients with a baseline body weight and one on-treatment body weight measurement. Last observation carried forward (LOCF) was used as imputation rule.||kg||Standard Error|Mean
759355|NCT00622284|Secondary|Body Weight Change From Baseline at Week 52|This key secondary endpoint, change from baseline, reflects the Week 52 body weight minus the baseline body weight. Means are treatment adjusted for baseline HbA1c, baseline weight and the number of previous antidiabetic-medications.|Baseline and week 52|This population includes the FAS further restricted to patients with a baseline body weight and one on-treatment body weight measurement. Last observation carried forward (LOCF) was used as imputation rule.||kg||Standard Error|Mean
759356|NCT00622284|Primary|HbA1c Change From Baseline at Week 104|This co-primary endpoint, change from baseline, reflects the Week 104 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications.|Baseline and week 104|The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.||Percent||Standard Error|Mean
759357|NCT00622284|Primary|HbA1c Change From Baseline at Week 52|This co-primary endpoint, change from baseline, reflects the Week 52 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications.|Baseline and week 52|The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.||Percent||Standard Error|Mean
759358|NCT00622336|Primary|Number of Participants With Adverse Events (AE) During the Extension Phase|An AE is any sign, symptom, illness, or diagnosis (either observed or volunteered) that appears or worsens during the course of the study Serious adverse event (SAE) = any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect; constitutes an important medical event. A treatment emergent AE is defined as any AE occurring or worsening on or after the first dose of study drug and within 30 days after the last dose of study drug. Safety and severity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 2.0; Severity of AEs were graded (including second primary malignancies) as Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe; Grade 4- Life-threatening; Grade 5-Fatal;|From 22 Oct 2009 to November 2013; AEs/SAEs were recorded from informed consent to 30 days post treatment discontinuation visit.|Included participants who were enrolled in the extension phase. The safety population included participants enrolled in the study and had received at least one dose of lenalidomide.||participants|||Number
759359|NCT00622336|Secondary|Duration of Response|Duration of response based on the Myeloma response determination criteria developed by Bladé et al 1998 and defined as time from the initial documented response (partial response or better) to confirmed disease progression, based on International Myeloma Working Group (IMWG) criteria.|Up to 70 months|Duration of response not analyzed per the sponsors decision.|||||
759360|NCT00622336|Secondary|Myeloma Response Rate|Myeloma response determination criteria developed by Bladé et al 1998. Complete Response (CR):Disappearance of monoclonal paraprotein. Remission Response (RR):75-99% reduction in monoclonal paraprotein/90-99% reduction in 24-hr urinary light chain excretion. Partial Response (PR):50-74% reduction in monoclonal paraprotein/50-89% reduction in 24-hr urinary light chain excretion. Stable Disease (SD):Criteria for PR or PD not met. Plateau Phase:If PR, stable monoclonal paraprotein (within 25% above or below nadir)/stable soft tissue plasmacytomas. Progressive Disease (PD):Disease worsens.|Up to 70 months|Myeloma Response Rate not analyzed per the sponsors decision.|||||
759361|NCT00622336|Secondary|Time to Progression|Time to progression based on the myeloma response determination criteria developed by Bladé et al 1998 and is defined as the time from registration to the first documented progression. The progressive disease criteria included increasing monoclonal paraprotein levels, bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia.|Up to 70 months|Time to progression not analyzed per the sponsors decision.|||||
759362|NCT00622336|Primary|Number of Participants With Adverse Events (AE) During the Treatment Phase|An AE is any sign, symptom, illness, or diagnosis (either observed or volunteered) that appears or worsens during the course of the study Serious adverse event (SAE) = any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect; constitutes an important medical event. A treatment emergent AE is defined as any AE occurring or worsening on or after the first dose of study drug and within 30 days after the last dose of study drug. Safety and severity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 2.0; Severity of AEs were graded (including second primary malignancies) as Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe; Grade 4- Life-threatening; Grade 5-Fatal;|Until data cut-off of 22 Oct 2009; AEs/SAEs were recorded from informed consent to 30 days post treatment discontinuation visit. Maximum exposure to Lenalidomide treatment was 1260 days.|The safety population included participants enrolled in the study and had received at least one dose of lenalidomide.||participants|||Number
759363|NCT00622388|Secondary|Volume of Distribution at Steady State (Vss) of Ofatumumab at the Eighth Infusion|Vss is the volume of distribution at steady state of ofatumumab.|Visit 9 (Week 7; up to 11 months after the last dose)|FAS. Data are presented for the number of participants attending each visit for whom the parameter can be calculated.||liters||Geometric Coefficient of Variation|Geometric Mean
759364|NCT00622388|Secondary|Clearance (CL) of Ofatumumab at the Eighth Infusion|CL is the clearance of drug from serum, which is defined as the volume of serum from which the drug is cleared per unit time.|Visit 9 (Week 7; up to 11 months after last dose)|FAS. Data are presented for the number of participants at each visit for whom the parameter can be calculated.||milliliters per hour (mL/h)||Geometric Coefficient of Variation|Geometric Mean
759365|NCT00622388|Secondary|Half-life (T1/2) for Ofatumumab at the Eighth Infusion|t1/2 is defined as terminal half-life and is the time required for the amount of drug in the body to decrease by half.|Visit 9 (Week 7; up to 11 months after last dose)|FAS. Data are provided for the number of participants at each visit for whom the parameter could be calculated.||hours||Geometric Coefficient of Variation|Geometric Mean
759366|NCT00622388|Secondary|Cmax and Ctrough for Ofatumumab at the First and Eighth Infusions|Cmax is defined as the maximum concentration of drug in serum samples. Ctrough is defined as the minimum observed concentration prior to the start of the next dose. No drug is present prior to the first infusion; therefore, there are no Ctrough results for the first dose.|Visit 2 (Week 0) and Visit 9 (Week 7)|FAS. Data are provided for the number of participants attending each visit.||micrograms per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
759367|NCT00622388|Secondary|AUC(0-inf) and AUC(0-168) for Ofatumumab at the Eighth Infusion|AUC is defined as the area under the ofatumumab concentration-time curve as a measure of drug exposure. AUC(0-168) is the AUC from the start of infusion to 168 hours after the start of the infusion; AUC(0-inf) is the AUC from the start of infusion extrapolated to infinity.|Visit 9 (Week 7; up to 11 months after last dose)|FAS. Data are provided for the number of participants attending each visit for whom the parameter value could be calculated. Participants contributing AUC(0-inf) data also contributed AUC(0-168) data.||micrograms*hour/milliliter (µg.h/mL)||Geometric Coefficient of Variation|Geometric Mean
761293|NCT00638963|Secondary|Number of Days With Brain Recurrence-free Survival (BRFS)|"BRFS was defined as the time interval from randomization to the appearance of brain metastases.
The analysis could not be performed due to low enrollment."|24,38, and 52 weeks||||||
759368|NCT00622388|Secondary|Percent Change From Screening in Complement (CH50) Levels|CH50 was mistakenly registered as an outcome measure with the protocol record. Samples were not collected, and no analysis will take place. Thus, no data will be reported for this outcome measure.|Screening and post-baseline visits (last visit was to occur 24 months post first dose)|FAS|||||
759369|NCT00622388|Secondary|Number of Participants Who Experienced at Least One Adverse Event (AE)|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. The protocol-defined AE reporting period was from the first infusion (Visit 2/Week 0) to Visit 18 (Month 24 of follow-up) or time of withdrawal (treatment and follow-up).|Time frame is from date of start of treatment to 2 years or withdrawal|FAS||participants|||Number
759370|NCT00622388|Secondary|Median Percent Change From Baseline in CD45+CD19+ and CD45+CD20+ Cells in the Peripheral Blood at the Indicated Visits|B cells (CD45+CD19+ and CD45+CD20+) were measured in peripheral blood samples by flow cytometry. Percent change from Baseline = (value at the indicated visits minus the value at Baseline divided by the value at Baseline) * 100.|Baseline and Visit 10 (Week 8), Visit 11 (Week 11), Visit 12 (Month 6), Visit 13 (Month 9), Visit 14 (Month 12), Visit 15 (Month 15), Visit 16 (Month 18), Visit 17 (Month 21), Visit 18 (Month 24), Visit 19 (Month 30), Visit 20 (Month 36)|FAS. Data are provided for the number of participants attending each visit.||percent change in cells||Full Range|Median
759371|NCT00622388|Secondary|Number of Participants With Positive Human Anti-human Antibodies (HAHA) at Screening and at Visits 12, 13, 14, and 18|HAHA are indicators of immune response to ofatumumab. Blood samples were collected from participants at Visits 1, 12, 13, 14, and 18 and analyzed in batches. The number of participants with positive results at each visit is reported.|Screening visit (=<14 days before treatment start), Visit 12 (Month 6), Visit 13 (Month 9), Visit 14 (Month 12), and Visit 18 (Month 24)|FAS. Data are provided for the number of participants attending each visit.||participants|||Number
759372|NCT00622388|Secondary|Overall Survival (OS)|Overall survival is defined as the time from first infusion to death. Overall survival was a secondary endpoint in the study. However, since many participants withdrew from the study after developing disease progression overall survival could not be reliably estimated.|From date of start of treatment to 5 years or withdrawal|FAS|||||
759373|NCT00622388|Secondary|Time to Next Diffuse Large B-Cell Lymphoma (DLBCL) Therapy|Time to next DLBCL therapy was defined as the time from the first infusion date to the time of the first administration of the next DLBCL treatment other than ofatumumab. If the participants were lost to follow-up, the endpoint was censored, and the censoring date was the date of the last attended visit at which the endpoint was assessed.|From date of start of treatment to 5 years or withdrawal|FAS||months||95% Confidence Interval|Median
759374|NCT00622388|Secondary|Progression-free Survival (PFS)|PFS was defined as the time from treatment start until progression or death.|From date of start of treatment to 2 years or withdrawal|FAS||months||95% Confidence Interval|Median
759375|NCT00622388|Secondary|Duration of Response|The duration of response was defined as the time from the initial response (CR or PR) to the time of relapse, progression, or death. If the participant was lost to follow-up, the endpoint was censored, and the censoring date was the date of the last attended visit at which the endpoint was assessed.|From date of start of treatment to 2 years or withdrawal|FAS. Only participants with CR or PR were analyzed.||months||95% Confidence Interval|Median
759376|NCT00622388|Primary|Number of Participants Classified as Responders and Non-responders for Objective Response|"According to the revised response criteria for malignant lymphoma, responders included participants with CR and PR, and non-responders included participants with stable disease (SD) and progressive disease (PD). Participants not evaluable (NE) were also considered to be non-responders. PD is defined as any new lesion or an increase by more than or equal to 50% of previously involved sites from baseline. SD is defined as failure to attain CR, PR, or PD."|6-month period from start of treatment (up to Week 24)|FAS||participants|||Number
759377|NCT00622388|Primary|Number of Participants With Objective Response|Objective response of ofatumumab treatment was assessed according to the “revised response criteria for malignant lymphoma.” Participants with objective response were defined as responders with complete remission (CR) or partial remission (PR) of disease. CR is defined as the disappearance of all evidence of disease, and PR is defined as the regression of measurable disease with no new sites of disease.|6-month period from start of treatment (up to Week 24)|Full Analysis Set (FAS): all participants who were exposed to study drug irrespective of their compliance to the planned course of treatment||participants|||Number
759378|NCT00622401|Primary|Number of Participants With Adverse Events Associated With Vaccination of Breast Cancer Patients With Dendritic Cell (DC)/Tumor Fusion Vaccine|Using CTCAE version 3, adverse events associated with the intervention were captured throughout the treatment portion of the study. All adverse events were then compiled and the number of patients who experienced these adverse events was recorded.|3 years|All three patients experienced adverse events that were determined to be at least possibly related to the vaccine. The number of times each toxicity was observed is captured in the adverse events section.||participants|||Number
759379|NCT00622401|Secondary|To Determine if Vaccination With DC/Tumor Fusions and rhIL-12 Results in Clinically Measurable Disease Responses.|This outcome was not measured because no patients were treated with rhIL-12.|3 years||||||
759380|NCT00622401|Secondary|To Determine if Cellular and Humoral Immunity is Induced by Serial Vaccination With DC/Tumor Fusion Cells and rhIL-12.|This outcome was not measured because no patients were treated with rhIL-12.|3 years||||||
759381|NCT00622427|Secondary|Change in Clinical Global Impression (CGI)|The CGI is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). The outcome measure is the percent difference between the total score for all subjects at day 1 and the total score for all subjects at day 14 of the study drug.|day 1 to day 14 of study drug|||percentage of change||Standard Deviation|Mean
759382|NCT00622427|Primary|Change in Baseline to 2 Weeks ADHD Rating Scale|It is an 18 item scale with 9 symptoms of inattention and 9 symptoms of Impulsivity and Hyperactivity. This scale is the gold standard in assessment of ADHD. Scores range from 0-54. There must be a score of 6 or more in either category to be diagnosed with ADHD. Severity ranges: 6-18 mild, 19-36 moderate, 37-54 severe. The outcome measure is the percentage difference between the total day 1 score for all subjects and the total 14 day score for all subjects.|day 1 to day 14 of study drug|||percentage of change||Standard Deviation|Mean
759383|NCT00622440|Secondary|Response With >75% Adherence|"Response assessed 12 weeks after treatment (week 60), by treatment adherence assessed at 48 weeks.
Late Clinical Response (LCR): HSIL present at week 48 but none at week 60; two independent reviews agree that HSIL absent at week 60.
Complete response (CR): No HSIL on histology or cytology (caveat: if HSIL at week 60, blinded chart notes and photographs were reviewed by two clinicians, and decision was reached by agreement or consensus whether HSIL had been missed at week 48. Cases that reviewers independently agreed had not been missed at week 48 were considered true recurrences)
Partial Clinical Response (PCR): HSIL on cytology with no HSIL histology, or improvement >50% in the number of lesions with HSIL, or an improvement >50% in lesion size, area, or clinical characteristics (e.g. acetowhite staining, Lugol's staining, or vascular changes were improved)
No Response (NR): HSIL present on histology, or improvement ≤ 50% in number, size, area or characteristics."|Baseline, 48 weeks, 60 weeks|Evaluable participants who finished 48 weeks of treatement and reported >75% adherence to treatment||participants|||Number
759384|NCT00622440|Secondary|Response With >50% Adherence|"Response assessed 12 weeks after treatment (week 60), by treatment adherence assessed at 48 weeks.
Late Clinical Response (LCR): HSIL present at week 48 but none at week 60; two independent reviews agree HSIL absent at week 60.
Complete response (CR): No HSIL on histology or cytology at weeks 48 or 60 (caveat: if HSIL at week 60, blinded chart notes and photographs reviewed by two clinicians, with decision by agreement or consensus whether HSIL had been missed at week 48. Cases that reviewers independently agreed had not been missed at week 48 were considered true recurrences)
Partial Clinical Response (PCR): HSIL on cytology with no HSIL histology, or improvement >50% in number of lesions with HSIL, or improvement >50% in lesion size, area, or clinical characteristics (e.g. acetowhite staining, Lugol's staining, or vascular changes improved)
No Response (NR): HSIL present on histology, or improvement ≤ 50% in number, size, area or characteristics."|Baseline, 48 weeks, 60 weeks|Evaluable participants who finished 48 weeks of treatement and reported >50% adherence to treatment||participants|||Number
759385|NCT00622440|Secondary|Estimate Effect Size for Phase 3 Trial|Secondary outcome stated in original protocol posting|Baseline, Week 60||07/2015||||
759386|NCT00622440|Secondary|Treatment Adherence|"Percent of recommended applications of cream reported in participant diary.
>75% = Excellent >50%-75% = Good >25%-50% = Poor <25% = Non-adherent"|48 weeks|Excludes 7 AIJP participants and 6 Placebo participants who dropped out before week 48. Excludes 1 Placebo participant deemed non-evaluable.||participants|||Number
759387|NCT00622440|Primary|Final Response of Anal High-grade Squamous Intraepithelial Lesions (HSIL)|"Response assessed 12 weeks after treatment.
Late Clinical Response (LCR): HSIL present at week 48 but none at week 60, with two independent reviews in agreement that HSIL absent at week 60.
Complete response (CR): No HSIL on histology or cytology at weeks 48 or 60 (caveat: if HSIL at week 60, blinded chart notes and photographs were reviewed by two clinicians, and decision was reached by agreement or consensus whether HSIL had been missed at week 48. Cases that reviewers independently agreed had not been missed at week 48 were considered true recurrences)
Partial Clinical Response (PCR): HSIL on cytology with no HSIL histology, or improvement >50% in the number of lesions with HSIL, or an improvement >50% in lesion size, area, or clinical characteristics (e.g. acetowhite staining, Lugol's staining, or vascular changes were improved)
No Response (NR): HSIL present at weeks 48 & 60 on histology, or improvement ≤ 50% in number, size, area or characteristics."|Baseline/screen, Week 48, Week 60|||participants|||Number
759388|NCT00622518|Secondary|Side Effects of Therapy||5 days|Specific side effects were collected on patients whose parents returned study diaries (44 from ear drop group and 50 from standard care only group). In addition, parents were telephoned and asked about any serious side effects.||participants|||Number
759389|NCT00622518|Primary|Resolution of Otitis Media Symptoms|Mean scores as measured on the Ear Treatment Group-5 scale. This scale quantifies severity of symptoms in children with otitis media. There are 5 components to the scale: fever, earache or tugging, feeding, irritability and sleep. For each component symptoms are rated as 0, 4 or 7 based on severity, with higher scores indicating more sever symptoms. For the primary outcome, the scores for each component were summed to determine an overall Ear Treatment Group -5 Scale score. Total scores range from 0-35. Two assessessments were conducted each day.|5 days|Data were analyzed on participants from whom data diaries were returned and who had data for an assessment. Data were analyzed on the following number of children at each assessment: 1- 50 standard care (SC),40 ear drop (ED) 2- 40SC 35ED 3- 49SC 37ED 4- 40SC 36ED 5- 44SC 35ED 6- 42SC 34ED 7- 44SC 34ED 8- 43SC 31ED 9- 44SC 33ED 10- 44SC 29ED||units on a scale||Standard Deviation|Mean
759390|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 23 Hours 45 Minutes Post-dose at the End of Each Treatment Period (Day 15)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|23 hours 45 minutes post-dose at the end of each treatment period (Day 15)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.||Liters||Standard Error|Least Squares Mean
759391|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 23 Hours 10 Minutes Post-dose at the End of Each Treatment Period (Day 15)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|23 hours 10 minutes post-dose at the end of each treatment period (Day 15)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.||Liters||Standard Error|Least Squares Mean
759392|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 22 Hours Post-dose at the End of Each Treatment Period (Day 15)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|22 hours post-dose at the end of each treatment period (Day 15)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.||Liters||Standard Error|Least Squares Mean
759438|NCT00622739|Primary|Young Mania Rating Scale (YMRS)|The Young Mania Rating Scale (YMRS) is a measure of the severity of manic symptoms. The scores on the scale range from 0-56. A score of more than or equal to 14 was the cut off for inclusion into this study. A higher score denotes increased severity of manic symptoms.|6 weeks of treatment|||units on a scale||Standard Error|Least Squares Mean
759393|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 20 Hours 45 Minutes Post-dose at the End of Each Treatment Period (Day 15)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|20 hours 45 minutes post-dose at the end of each treatment period (Day 15)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.||Liters||Standard Error|Least Squares Mean
759394|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 20 Hours 10 Minutes Post-dose at the End of Each Treatment Period (Day 15)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|20 hours 10 minutes post-dose at the end of each treatment period (Day 15)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.||Liters||Standard Error|Least Squares Mean
759395|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 14 Hours Post-dose at the End of Each Treatment Period (Day 14)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|14 hours post-dose at the end of each treatment period (Day 14)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.||Liters||Standard Error|Least Squares Mean
759396|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 11 Hours 45 Minutes Post-dose at the End of Each Treatment Period (Day 14)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|11 hours 45 minutes post-dose at the end of each treatment period (Day 14)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.||Liters||Standard Error|Least Squares Mean
759397|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 11 Hours 10 Minutes Post-dose at the End of Each Treatment Period (Day 14)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|11 hours 10 minutes post-dose at the end of each treatment period (Day 14)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.||Liters||Standard Error|Least Squares Mean
759398|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 10 Hours Post-dose at the End of Each Treatment Period (Day 14)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|10 hours post-dose at the end of each treatment period (Day 14)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.||Liters||Standard Error|Least Squares Mean
759399|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 8 Hours Post-dose at the End of Each Treatment Period (Day 14)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|8 hours post-dose at the end of each treatment period (Day 14)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.||Liters||Standard Error|Least Squares Mean
759400|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 6 Hours Post-dose at the End of Each Treatment Period (Day 14)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|6 hours post-dose at the end of each treatment period (Day 14)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.||Liters||Standard Error|Least Squares Mean
759401|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 5 Hours Post-dose at the End of Each Treatment Period (Day 14)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|5 hours post-dose at the end of each treatment period (Day 14)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.||Liters||Standard Error|Least Squares Mean
759402|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 4 Hours Post-dose at the End of Each Treatment Period (Day 14)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|4 hours post-dose at the end of each treatment period (Day 14)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.||Liters||Standard Error|Least Squares Mean
759403|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 3 Hours Post-dose at the End of Each Treatment Period (Day 14)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|3 hours post-dose at the end of each treatment period (Day 14)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.||Liters||Standard Error|Least Squares Mean
759462|NCT00623194|Secondary|Vital Signs: Pulse|Pulse at week 104|At 104 weeks|The safety analysis set included all subjects with a signed informed consent who were exposed in the extension.||beats/minute||Standard Deviation|Mean
759463|NCT00623194|Secondary|Vital Signs: Blood Pressure|Blood pressure (Systolic and Diastolic) after 104 weeks.|At 104 weeks|The safety analysis set included all subjects with a signed informed consent who were exposed in the extension.||mmHg||Standard Deviation|Mean
759404|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 2 Hours Post-dose at the End of Each Treatment Period (Day 14)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|2 hours post-dose at the end of each treatment period (Day 14)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.||Liters||Standard Error|Least Squares Mean
759405|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 1 Hour Post-dose at the End of Each Treatment Period (Day 14)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|1 hour post-dose at the end of each treatment period (Day 14)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.||Liters||Standard Error|Least Squares Mean
759406|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 30 Minutes Post-dose at the End of Each Treatment Period (Day 14)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|30 minutes post-dose at the end of each treatment period (Day 14)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.||Liters||Standard Error|Least Squares Mean
759407|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 15 Minutes Post-dose at the End of Each Treatment Period (Day 14)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|15 minutes post-dose at the end of each treatment period (Day 14)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.||Liters||Standard Error|Least Squares Mean
759408|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 5 Minutes Post-dose at the End of Each Treatment Period (Day 14)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|5 minutes post-dose at the end of each treatment period (Day 14)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.||Liters||Standard Error|Least Squares Mean
759409|NCT00622635|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Each Treatment Period (Day 15)|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of each treatment period. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|After 14 days|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.||Liters||Standard Error|Least Squares Mean
759410|NCT00622700|Other Pre-specified|Core Treatment Period: Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA)|"PCSA values are abnormal values considered medically important by the Sponsor according to predefined criteria based on literature review.
Hepatic parameters thresholds were defined as follows:
Alanine Aminotransferase (ALT) >3, 5, 10 or 20 upper limit of normal(ULN);
Aspartate aminotransferase (AST) >3, 5, 10 or 20 ULN;
Alkaline Phosphatase >1.5 ULN;
Total Bilirubin (TB) >1.5, 2, or 3 ULN;
ALT >3 ULN and TB >2 ULN."|From first study drug intake up to 112 days after last intake in the placebo-controlled period or up to first intake in the extension treatment period, whichever occurred first|Safety population as described in Outcome Measure 13. Here 'n' signifies the number of participants for the treatment group who had that parameter assessed at post-baseline.||participants|||Number
759411|NCT00622700|Secondary|Extension Treatment Period: Overview of Adverse Events (AEs)|AEs are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study. Safety population included all randomized population who actually received at least 1 dose of the IMP in extension and analyzed according to the treatment actually received in core study followed by treatment actually received in the extension treatment period.|From re-randomization up to 283 Weeks|Analysis was performed on Safety population. In Placebo/teriflunomide 7mg arm, 2 received 7mg in the core period; In Placebo/teriflunomide 14mg, 1 received 7mg in the core period, hence, they were included in the 7mg/7mg arm in extension period as treatment received in the core period for consistency.||participants|||Number
759412|NCT00622700|Secondary|Extension Treatment Period: Time to Conversion to Clinically Deﬁnite Multiple Sclerosis (CDMS)|Conversion to CDMS was defined by the occurrence of a relapse, which was defined as a new neurological abnormality separated by at least 30 days from onset of a preceding clinical event, presented for at least 24 hours and occurred in the absence of fever or known infection. Percent probability of conversion was estimated using Kaplan-Meier method.|From randomization in the core period up to 390 Weeks (Extension treatment period [maximum exposure: 283 Weeks])|ITT Population: all randomized participants in the extension who had at least 1 day IMP exposure. Participants were analyzed according to the treatment group allocated by the randomization in the core study followed by the re-randomized treatment group during the extension period.||Percent probability||95% Confidence Interval|Number
759413|NCT00622700|Secondary|Core Treatment Period: Overview of Adverse Events (AEs)|AEs are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.|From first study drug intake up to 112 days after last intake in the placebo-controlled period or up to first intake in the extension treatment period, whichever occurred first|Safety population:all randomized participants exposed to study medication; analyzed according to drug actually received. In Placebo arm, 4 received teriflunomide 7mg & 2 received teriflunomide 14mg, hence they were included in respective teriflunomide arm. Participants who were randomized but not treated were excluded (2 in each teriflunomide arm).||participants|||Number
764973|NCT00673075|Primary|Peripheral Diastolic Blood Pressure (DBP)|Peripheral diastolic blood pressure (DBP) at post-baseline (visit 13, week 18)|18 weeks post initiation of randomized treatment|||mmHg||Standard Error|Mean
759414|NCT00622700|Secondary|Core Treatment Period: Change From Baseline in Fatigue Impact Scale (FIS) Total Score at Week 108|FIS is a participant-reported scale that qualifies the impact of fatigue on daily life in participants with MS. It consists of 40 statements that measure fatigue in three areas; physical, cognitive, and social. FIS total score ranges from 0 (no problem) to 160 (extreme problem). Least-square means were estimated using a Mixed-effect model with repeated measures [MMRM] on FIS total score data adjusted for or baseline monofocal/multifocal status, region, visit, treatment-by-visit interaction, baseline value and baseline-by-visit interaction.|Baseline, Week 108|ITT population, but including only participants who had post-baseline data.||units on a scale||Standard Error|Least Squares Mean
759415|NCT00622700|Secondary|Core Treatment Period: Change From Baseline in EDSS at Week 108|EDSS is an ordinal scale in half-point increments that qualifies disability in participants with MS. It consists of 8 ordinal rating scales assessing seven functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS). Least-square means were estimated using a Mixed-effect model with repeated measures (MMRM) on cubic root transformed volume data adjusted for baseline monofocal/multifocal status, region, visit, treatment-by-visit interaction, baseline value and baseline-by-visit interaction|Baseline, Week 108|ITT population, but including only participants who had post-baseline data.||units on a scale||Standard Error|Least Squares Mean
759416|NCT00622700|Secondary|Core Treatment Period: Time to 12-Week Sustained Disability Progression|The 12-week sustained disability progression was defined as increase from baseline of at least 1-point in EDSS score (at least 0.5-point for participants with baseline EDSS score of greater than [>] 5.5) that persisted for at least 12 weeks. Percent probability of participants free of 12-week sustained disability progression at 24, 48, and 108 weeks was estimated using Kaplan-Meier method.|Up to a maximum of 108 weeks depending on time of enrollment|ITT population.||percent probability||95% Confidence Interval|Number
759417|NCT00622700|Secondary|Core Treatment Period: Brain MRI Assessment: Percent Change From Baseline in Atrophy|Atrophy was measured by MRI scan.|Baseline, Week 108|ITT population, but including only participants who had post-baseline data.||percent change||Standard Deviation|Mean
759418|NCT00622700|Secondary|Core Treatment Period: Brain MRI Assessment: Change From Baseline in Volume of T2 Lesion Component|Volume of T2 lesion component was measured by MRI scan. Least-square means were estimated using a Mixed-effect model with repeated measures (MMRM) on cubic root transformed volume data adjusted for baseline monofocal/multifocal status, region, visit, treatment-by-visit interaction, cubic root transformed baseline value, and baseline-by-visit interaction.|Baseline, Week 108|ITT population, but including only participants who had post-baseline data.||milliliter||Standard Error|Least Squares Mean
759419|NCT00622700|Secondary|Core Treatment Period: Brain MRI Assessment: Change From Baseline in Volume of Hypointense Post-Gadolinium T1 Lesion Component|Volume of hypointense post-gadolinium T1 lesion component was measured by MRI scan. Least-square means were estimated using a Mixed-effect model with repeated measures (MMRM) on cubic root transformed volume data adjusted for baseline monofocal/multifocal status, region, visit, treatment-by-visit interaction, cubic root transformed baseline value, and baseline-by-visit interaction|Baseline, Week 108|ITT population, but including only participants who had post-baseline data.||milliliter||Standard Error|Least Squares Mean
759420|NCT00622700|Secondary|Core Treatment Period: Brain MRI Assessment: Volume of Gadolinium Enhancing (Gd-enhancing) T1-lesions Per MRI Scan|Total volume of Gd-enhancing T1-lesions per scan is the sum of the volumes of Gd-enhancing T1-lesions observed during the treatment period divided by the total number of scans performed during the treatment period. To account for the different numbers of scans performed among the participants, a Poisson regression model with robust error variance was used (total number of Gd-enhancing T1-lesions as response variable, treatment, baseline monofocal/multifocal status, region and baseline number of Gd-enhancing T1-lesions as covariates, and log-transformed number of scans as an offset variable).|Up to a maximum of 108 weeks depending on time of enrollment|ITT population, but including only participants who had post-baseline data.||milliliters per scan|||Number
759421|NCT00622700|Secondary|Core Treatment Period: Brain MRI Assessment: Number of Gadolinium Enhancing (Gd-enhancing) T1-lesions Per MRI Scan (Poisson Regression Estimates)|Number of Gd-enhancing T1-lesions per scan is the total number of Gd-enhancing T1-lesions that occurred during the treatment period divided by the total number of scans performed during the treatment period. To account for the different numbers of scans performed among the participants, a Poisson regression model with robust error variance was used (total number of Gd-enhancing T1-lesions as response variable, treatment, baseline monofocal/multifocal status, region and baseline number of Gd-enhancing T1-lesions as covariates, and log-transformed number of scans as an offset variable).|Up to a maximum of 108 weeks depending on time of enrollment|ITT population, but including only participants who had post-baseline data.||lesions per scan||95% Confidence Interval|Number
759422|NCT00622700|Secondary|Core Treatment Period: Brain Magnetic Resonance Imaging (MRI) Assessment: Change From Baseline in Total Lesion Volume at Week 108|The total lesion volume (burden of disease) is the total volumes of hyperintense on T2 plus hypointense on T1 as measured by MRI scan. Least-square means were estimated using a Mixed-effect model with repeated measures (MMRM) on cubic root transformed volume data with factors for treatment, baseline monofocal/multifocal status, region, visit, treatment-by-visit interaction, cubic root transformed baseline burden of disease, and baseline-by-visit interaction.|Baseline, Week 108|ITT population, but including only participants who had post-baseline data.||milliliter||Standard Error|Least Squares Mean
759423|NCT00622700|Secondary|Core Treatment Period: Annualized Relapse Rate (ARR)|ARR is the total number of confirmed relapses that occurred during the treatment period divided by the total number of patient-years treated. Each episode of relapse (appearance, or worsening of a clinical symptom that was stable for at least 30 days, that persisted for a minimum of 24 hours in the absence of fever) was to be confirmed by an increase in EDSS score or Functional System scores. ARR was assessed using Poisson regression model with robust error variance. To account for the different treatment durations among participants, a Poisson regression model with robust error variance was used (total number of confirmed relapses onset between randomization date and last dose date as the response variable, treatment, region and baseline monofocal/multifocal status as covariates, and log-transformed treatment duration as an offset variable).|Up to a maximum of 108 weeks depending on time of enrollment|ITT population.||relapses per patient year||95% Confidence Interval|Number
764974|NCT00673114|Secondary|Number of Participants With Donor Cells at 100 Days Post-transplant||Post transplant|||participants|||Number
759424|NCT00622700|Secondary|Core Treatment Period: Time to Conversion to Definite Multiple Sclerosis (DMS)|Conversion to DMS was demonstrated by dissemination of MRI lesions in time (as per McDonald criteria) or a relapse, whichever occurs first. MRI Imaging criteria were detection of Gadolinium (Gd) enhancement at least 3 months after onset of initial clinical event, if not at site corresponding to initial event; detection of new T2 lesion if it appears at any time compared with reference scan (done at time of screening) done at least 30 days after onset of the initial clinical event. Occurrence of relapse was defined as new neurological abnormality separated by at least 30 days from onset of preceding clinical event, present for at least 24 hours and occurring in absence of fever or known infection. New clinical abnormality (neurological sign) that is consistent with participant's symptoms with increase in at least one Functional System (FS) or EDSS score compared to last EDSS assessment. Percent probability of conversion at 24, 48, and 108 weeks was estimated using Kaplan-Meier method.|Up to a maximum of 108 weeks depending on time of enrollment|ITT population.||percent probability||95% Confidence Interval|Number
759425|NCT00622700|Primary|Core Treatment Period: Time to Conversion to Clinically Deﬁnite Multiple Sclerosis (CDMS)|Conversion to CDMS was defined by the occurrence of a relapse, which was defined as a new neurological abnormality separated by at least 30 days from onset of a preceding clinical event, presented for at least 24 hours and occurred in the absence of fever or known infection. Percent probability of conversion at 24, 48, and 108 weeks was estimated using Kaplan-Meier method.|Up to a maximum of 108 weeks depending on time of enrollment|Intent-to-treat (ITT) population included all randomized participants who had at least 1 day study medication exposure. Participants were analyzed in the treatment group to which they were randomized.||percent probability||95% Confidence Interval|Number
759426|NCT00622713|Secondary|Mean Change From Baseline to Week 24 in the Mini-Zarit Inventory Score|The Mini-Zarit Inventory assesses the burden of a caregiver in caring for a patient. The inventory is composed of 5 questions which are rated according to the following answers: 0 = never, ½ = sometimes, 1 = often. The ratings on the 5 questions are added together resulting in a total score of 0 to 7 with a higher score indicating greater caregiver burden.|Baseline to week 24|The Intent-to-Treat (ITT) population was defined as all patients who were administered at least one dose of study medication and were assessed for efficacy at least 1 time.||Scores on a scale||Standard Deviation|Mean
759427|NCT00622713|Secondary|Mean Change From Baseline to Week 24 in the Mini-Mental State Examination (MMSE) Score|The MMSE is a brief, practical screening test for cognitive dysfunction. The test consists of five sections (orientation, registration, attention-calculation, recall, and language) and results in a total possible score from 0 to 30, with higher scores indicating better function. A positive change score indicates improvement from baseline.|Baseline to week 24|The Intent-to-Treat (ITT) population was defined as all patients who were administered at least one dose of study medication and were assessed for efficacy at least 1 time.||scores on a scale||Standard Deviation|Mean
759428|NCT00622713|Secondary|Mean Change From Baseline to Week 24 in the 4-item Instrumental Activities of Daily Living (4-IADL) Score|The 4-IADL assesses the ability of a patient to autonomously perform 4 activities of daily living: Use the telephone, take medications, use public transport, and manage their own budget. Each activity is assessed by a series of questions and rated on a scale of 1 to 4. Scores on the 4 activities are combined for a total score ranging from 1 to 16. A lower score indicates a more self-sufficient individual. A positive change from baseline score indicates worsening.|Baseline to week 24|The Intent-to-Treat (ITT) population was defined as all patients who were administered at least one dose of study medication and were assessed for efficacy at least 1 time.||scores on a scale||Standard Deviation|Mean
759429|NCT00622713|Secondary|Clinical Global Impression of Change (CGI-C) by Physician|"The CGIC is an assessment tool used by a clinician to make a judgment of the severity or a change of a patient's condition. The clinician relies solely on information obtained from the patient at the Baseline visit as well as clinical information obtained throughout the study period. The CGIC is rated on the following seven-point scale:very much improved, much improved, slightly improved, unchanged, slightly worsened, much worsened and very much worsened."|Baseline and week 24|The Intent-to-Treat (ITT) population was defined as all patients who were administered at least one dose of study medication and were assessed for efficacy at least 1 time. Last observation carried forward (LOCF) was used for missing values.||Percentage of participants|||Number
759430|NCT00622713|Primary|Percentage of Patients Who Achieved and Maintained the Maximum Dose of 10 cm^2 Rivastigmine Patch for at Least 8 Weeks During 24 Weeks Study|The primary endpoint was the percentage of patients who were able to tolerate (and stay on for at least 8 weeks) rivastigmine target patch size 10 cm^2.|24 weeks|The Intent-to-Treat (ITT) population was defined as all patients who were administered at least one dose of study medication and were assessed for efficacy at least 1 time.||Percentage of participants|||Number
759431|NCT00622726|Secondary|Visual Acuity|The visual acuity will be measured at 20 feet with figures or letters from all infants able to cooperate.|Age 7 years.||||||
759432|NCT00622726|Secondary|Myopia in Zone I and Posterior Zone II of Infant Eyes|Myopia was determined via refraction using a retinoscope and lenses. Myopia is defined as a refractive error reported in Diopters.|2.5 years of age|As of 6/2013, there were 13 deaths/ 26 eyes. Exclusions from surviving 137 infants/ 274 eyes: 6 infants/19 eyes with intraocular surgery--leaving: 131 infants/ 255 eyes; 14 infants/ 21 eyes had recurrence and 22 infants/ 44 eyes were lost to follow-up--leaving: 95 infants/ 190 eyes. Thus, only the refractions on these infants/ eyes are given.||Diopters|Eyes|Standard Deviation|Mean
759433|NCT00622726|Primary|Number of Eyes Showing Recurrence of Neovascularization Arising From the Retinal Vessels and Requiring Re-treatment|"For Bevacizumab: Regrowth of new vessels at the site of the original extraretinal fibrovascular proliferation and/or at the site of the anterior edge of inner retinal vascularization.
For Laser: Regrowth of new vessels from the vessels at the anterior edge of inner retinal vascularization (remaining after retinal ablation)."|54 weeks postmenstrual age (window of 50 to 70 weeks)|Both eyes of all surviving infants were analyzed for recurrence: thus, 143 surviving infants and 286 eyes were analyzed. Reporting the number of eyes that developed recurrences||eyes with recurrences|Eyes||Number
759434|NCT00622739|Secondary|Children's Depression Rating Scale||Weekly||||||
759435|NCT00622739|Secondary|AIMS (Abnormal Involuntary Movement Scale)||Weekly||||||
759436|NCT00622739|Secondary|SAFTEE (Side Effects Rating Scale)||Weekly||||||
759437|NCT00622739|Secondary|Clinical Global Impressions (CGI) Scale||Weekly||||||
759439|NCT00622869|Secondary|Change in Renal Function From Randomization to Months 12 and 24|"Change in renal function was assessed by the estimated Glomerular Filtration Rate (eGFR) using the abbreviated (4 variables) Modification of Diet in Renal Disease (MDRD-4) formula which was developed by the MDRD Study Group and has been validated in patients with chronic kidney disease. The MDRD-4 formula used for the eGFR calculation is: eGFR (mL/min/1.73m^2) = 186.3*(C^-1.154)*(A^-0.203)*G*R, where C is the serum concentration of creatinine (mg/dL), A is age (years), G=0.742 when gender is female, otherwise G=1, R=1.21 when race is black, otherwise R=1.
The changes in renal function were analyzed via analysis of covariance (ANCOVA) with treatment, pre-transplant hepatitis C virus status and randomization eGFR as covariates. Based on these ANCOVA analyses, the least-squares mean and standard errors of change were reported."|Randomization to Month 24|Intent-to-treat population: All randomized patients.||mL/min/1.73m^2||Standard Error|Least Squares Mean
759440|NCT00622869|Secondary|Incidence Rate of Treated Biopsy Proven Acute Rejection (tBPAR) at Months 12 and 24|"tBPAR was defined as an acute rejection confirmed by biopsy with a Rejection Activity Index (RAI) score ≥ 3, which was treated with anti-rejection therapy. Liver biopsies were collected for all cases of suspected acute rejection preferably within 24 hours, at the latest within 48 hours, whenever clinically possible. The RAI is used to score liver biopsies with acute rejection and is composed of 3 categories (portal inflammation, bile duct inflammation damage, venous endothelial inflammation) each scored on a scale of 0 (absent) to 3 (severe) by a trained pathologist. The total RAI score = the sum of the scores of the 3 categories and ranges from 0 to 9, with a higher score indicating greater rejection. The graft was presumed to be lost on the day the patient was newly listed for a liver graft, they received a graft re-transplant, or they died.
The incidence rates of tBPAR were estimated with a Kaplan-Meier product-limit formula."|Randomization to Month 24|Intent-to-treat population: All randomized patients.||Percentage|||Number
759441|NCT00622869|Secondary|Incidence Rate of Composite Efficacy Failure From Randomization to Month 24|"Composite efficacy failure was defined as treated biopsy proven acute rejection (tBPAR), graft loss, or death.
The incidence rates of composite efficacy failure were estimated with a Kaplan-Meier product-limit formula."|Randomization to Month 24|Intent-to-treat population: All randomized patients.||Percentage|||Number
759442|NCT00622869|Primary|Incidence Rate of Composite Efficacy Failure From Randomization to Month 12|"Composite efficacy failure was defined as treated biopsy proven acute rejection (tBPAR), graft loss, or death. A BPAR was defined as an acute rejection confirmed by biopsy with a Rejection Activity Index (RAI) score ≥ 3. tBPAR was defined as a BPAR which was treated with anti-rejection therapy. The RAI is used to score liver biopsies with acute rejection and is composed of 3 categories (portal inflammation, bile duct inflammation damage, venous endothelial inflammation) each scored on a scale of 0 (absent) to 3 (severe) by a trained pathologist. The total RAI score = the sum of the scores of the 3 categories and ranges from 0 to 9, with a higher score indicating greater rejection. The graft was presumed to be lost on the day the patient was newly listed for a liver graft, they received a graft re-transplant, or they died.
The incidence rates of composite efficacy failure were estimated with a Kaplan-Meier product-limit formula."|Randomization to Month 12|Intent-to-treat population: All randomized patients.||Percentage of participants|||Number
759443|NCT00622908|Secondary|Eradication of Baseline Pathogens Day 4 (+/- 1 Day)|Bacterial species eradication of baseline bacterial infection|Visit 2 - Day 4 (+/- 1 day)|Intent to treat population, culture confirmed. Missing values and discontinued patients imputed as failures.||Participants|||Number
759444|NCT00622908|Secondary|Clinical Resolution of Baseline Bacterial Conjunctivitis Day 4 (+/- 1 Day)|The absence of conjunctival discharge, bulbar conjunctival injection and palpebral conjunctival injection.|Visit 2 - Day 4 (+/- 1 day)|Intent to treat population, culture confirmed. Missing values and discontinued patients imputed as failures.||Participants|||Number
759445|NCT00622908|Primary|Eradication of Baseline Pathogens (Day 8 or 9)|Bacterial species eradication of baseline bacterial infection|Visit 3 - Day 8 or day 9|Intent to treat population, culture confirmed. Missing values and discontinued patients imputed as failures.||Participants|||Number
759446|NCT00622908|Primary|Clinical Resolution of Baseline Bacterial Conjunctivitis (Day 8 or 9)|Resolution of conjunctival discharge, bulbar conjunctival injection and palpebral conjunctival injection.|Visit 3 - day 8 or 9|Intent to treat population, culture confirmed. Missing values and discontinued patients imputed as failures.||Participants|||Number
759447|NCT00623012|Secondary|Disease Free Survival|achieved disease free in regard to leukemia|up to 10 weeks|||participants|||Number
759448|NCT00623012|Secondary|Overall Survival|achieved overall survival in regard to leukemia|up to 10 weeks|||participants|||Number
759449|NCT00623012|Primary|Improvement of the Rate of Graft Versus Host Disease (GVHD) From the Accepted Rate of 74%.|Percentage of patients free from graft versus host disease|up to 8 weeks|||percentage of patients|||Number
759450|NCT00623103|Secondary|UPDRS Part V Stage (Modified Hoehn and Yahr Staging)at Baseline, Week 8,16,24,52 and 76 (or Early Discontinuation)|Unified Parkinson Disease Rating Scale (UPDRS) is a 6 part Parkinson's disease specific rating scale that estimates clinical function taking into consideration both disability (functional deficits) and impairment (objective clinical signs). UPDRS Part V is assessed by the modified Hoehn and Yahr Staging Scale. The scale ranges from 0 (no signs of disease) to 5 (wheelchair bound or bedridden unless aided).|From Baseline to Week 8, 16, 24, 52 and 76 (or early discontinuation)|The Safety population consisted of all patients who have received at least one dose of study drug and have had at least 1 safety measurement after baseline. n=indicates patients with observation during different timepoints.||Score||Standard Deviation|Mean
759451|NCT00623103|Secondary|Change in Alzheimer's Disease Cooperative Study-Activities Of Daily Living (ADCS-ADL) Scores at Weeks 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline|"The 23 item caregiver-based ADL scale of the dementia Alzheimer’s disease Cooperative Study-Activities of Daily Living (ADCS-ADL) was used for analysis. This is a caregiver rated questionnaire of 23 items, with possible scores over a range of 0-78, where 78 denote full functioning with no impairment. The total score was derived by adding up the item scores of the 23 items.
The change from baseline was calculated such that a positive change indicates an improvement."|From Baseline to Week 16, 24, 52 and 76 (or early discontinuation)|Intent-to-treat population which included all patients who received at least 1 dose of study drug and had at least 1 pre- and post-baseline assessment for 1 of the efficacy variables. Last observation carried forward. (LOCF).||Score||Standard Deviation|Mean
764975|NCT00673114|Secondary|Rates of Leukemic Relapse|Number of participants relapsed|Up to 2 years post transplant|||participants|||Number
759452|NCT00623103|Secondary|Change in Neuropsychiatric Inventory-10 (NPI-10) Scores at Weeks 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline|The parameter for analysis was the change from baseline of total score of 10 items on the NPI scale (NPI-10). The total score is a sum of the 10 domains, where the score for a domain is defined as the product of frequency (range: 1-4) and severity (range: 1-3). Each domain has a maximum score of 12 and all domains were equally weighted for total score(thus the range for the total score is 0 to 120 with 0 being completely healthy to 120 which is the worse score patient can get). The change from baseline was calculated such that a negative number indicates an improvement (symptom reduction).|At Week 16, 24, 52 and 76 (or early discontinuation)|Intent-to-treat population which included all patients who received at least 1 dose of study drug and had at least 1 pre- and post-baseline assessment for 1 of the efficacy variables. Last observation carried forward. (LOCF)||Score||Standard Deviation|Mean
759453|NCT00623103|Secondary|Change in Ten Point Clock Test (TPCT) Scores at Weeks 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline|The Ten Point Clock Test measures executive functioning and visuospatial skills. Participants are asked to put numbers on the face of a clock and then make the clock read 10 minutes after 11. Points are awarded on a scale of 0 to 10 for spacing of specific numbers and the positions of the hands. The change from baseline was calculated such that a positive number indicates improvement.|From Baseline to Weeks 16, 24, 52 and 76|Intent-to-treat population which included all patients who received at least 1 dose of study drug and had at least 1 pre- and post-baseline assessment for 1 of the efficacy variables. Last observation carried forward. (LOCF)||Score on a scale||Standard Deviation|Mean
759454|NCT00623103|Secondary|Change in Mattis Dementia Rating Scale (Mattis DRS-2) Scores at Weeks 16, 24, 52 and 76 Compared to Baseline|Mattis DRS-2 is a measure of cognitive status. The total score is the sum of 5 subscale scores: Attention [0-37], Initiation/Perservation [0-37] (performing alternating movements), Construction [0-6] (copying designs), Conceptualization [0-39] (similarities) and Memory [0-25] (sentence recall, design recognition)for a total possible score of 0-144. Higher score is reflective of better cognitive function, lower scores associated with more pronounced cognitive deficit. The change from baseline was calculated such that a positive number indicates an improvement.|From Baseline to Weeks 16, 24, 52 and 76|Intent-to-treat population which included all patients who received at least 1 dose of study drug and had at least 1 pre- and post-baseline assessment for 1 of the efficacy variables. Last observation carried forward. (LOCF)||Score on a scale||Standard Deviation|Mean
759455|NCT00623103|Secondary|Change in Unified Parkinson Disease Rating Scale (UPDRS) Part III Motor Examination Scores at Weeks 8, 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline|Unified Parkinson Disease Rating Scale (UPDRS) is a 6 part Parkinson's disease specific rating scale that estimates clinical function taking into consideration both disability (functional deficits) and impairment (objective clinical signs). Part III records the motor examination in Items 18-31 rated on a scale of 0 to 4 with (0 being absent/ normal and 4 being the worse) for a total possible score of 0 to 56.|From Baseline to Weeks 8, 16, 24, 52 and 76|"Safety population consisted of all participants who received at least 1 dose of study drug and had 1 post-baseline safety measurement. n in each of the categories is the number of participants at each time point with non-missing baseline and post-baseline measurements."||Score on a scale||Standard Deviation|Mean
759456|NCT00623103|Primary|Percentage of Participants With Study Drug Discontinuations Due to Predefined AEs That Are Due, or Potentially Due, to Worsening of PD Motor Symptoms (Tremor, Muscle Rigidity, Bradykinesia, Fall)|The discontinuations due to these AEs were summarized by presenting the number and percentage of patients having any of the 4 AEs or discontinued due to any of the 4 predefined AEs (tremor, muscle rigidity, bradykinesia, and fall) in each treatment group. The 95% CIs associated with these rates were also presented.|76 Weeks|Safety Population consisted of all participants who received at least 1 dose of study drug and had 1 post-baseline safety measurement. Participants with observation at 76 weeks were included in this analysis.||Percentage of participants||95% Confidence Interval|Number
759457|NCT00623103|Primary|Percentage of Participants With Adverse Events (AEs) Due, or Potentially Due, to Worsening of Parkinson Disease (PD) Motor Symptoms (Tremor, Muscle Rigidity, Bradykinesia, Fall)|The AEs were summarized by presenting the number and percentage of patients having any of the 4 AEs or discontinued due to any of the 4 predefined AEs (tremor, muscle rigidity, bradykinesia, and fall)in each treatment group. The 95% CIs associated with the rates were also presented.|76 Weeks|Safety Population consisted of all participants who received at least 1 dose of study drug and had 1 post-baseline safety measurement. Participants with observation at 76 weeks were included in this analysis.||Percentage of participants||95% Confidence Interval|Number
759458|NCT00623181|Other Pre-specified|Number of Participants Reporting Solicited Systemic Reactions After Vaccine Injection|"Solicited systemic reactions: Fever (temperature); Headache; Malaise; and Myalgia.
Data for this outcome were based on the first vaccination type, intradermal or intramuscular."|Days 0 through 7 post-vaccination|Safety parameters were assessed in all enrolled and vaccinated subjects, intend-to-treat population.||Participants|||Number
759459|NCT00623181|Other Pre-specified|Number of Participants Reporting Any Solicited Injection Site Reactions After Vaccine Injection|"Solicited injection site reactions: Pain, Pruritus, Erythema, Swelling, Induration, Ecchymosis.
Data for this outcome were combined for responses following a similar type of vaccination route in the entire study population."|Days 0 through 7 post-vaccination|Safety parameters were assessed in all enrolled and vaccinated participants, intend-to-treat population.||Participants|||Number
759460|NCT00623181|Primary|Continuous Summary of Pain or Other Discomfort Immediately After Vaccination and on Days 3 and 7 Post-vaccination|"Numerical scores were assigned to pain by participants on the preference questionnaire as: None = 0; Hardly Any = 1, 2; Mild = 3, 4; Moderate = 5, 6; Severe = 7, 8; or Unbearable = 9, 10.
Data for this outcome were combined for responses following a similar type of vaccination route in the entire study population."|Days 0, 3, and 7 after vaccination|||Scores on a scale||Standard Deviation|Mean
759461|NCT00623181|Primary|Categorical Summary of Pain or Other Discomfort Immediately After Vaccination and on Days 3 and 7 Post-vaccination|"Pain or other discomfort was assessed on a scale of 0 to 10 (None = 0; Hardly Any = 1, 2; Mild = 3, 4; Moderate = 5, 6; Severe = 7, 8; Unbearable = 9, 10) according to route of administration: intradermal (ID) as Group 1 and intramuscular (IM) as Group 2.
Data for this outcome were combined for responses following a similar type of vaccination route in the entire study population."|Day 0 and up to 7 days post-vaccination|Pain or other discomfort was assessed in the Per-Protocol Population. Data were combined for responses following a similar type of vaccination route.||Participants|||Number
759464|NCT00623194|Secondary|Fundoscopy/Fundus Photography|"Fundoscopy after 104 weeks. Abn. CS = Abnormal, clinically significant Abn. NCS = Abnormal, Not clinically significant
Abn. CS = Abnormal, clinically significant Abn. NCS = Abnormal, Not clinically significant"|at 52 weeks and at 104 weeks|The safety analysis set included all subjects with a signed informed consent who were exposed in the extension.||participants|||Number
759465|NCT00623194|Secondary|Laboratory Values: Leukocytes and Thrombocytes|Leukocytes and Thrombocytes after 104 weeks.|At 104 weeks|The safety analysis set included all subjects with a signed informed consent who were exposed in the extension.||10^9/L||Standard Deviation|Mean
759466|NCT00623194|Secondary|Laboratory Values: Alkaline Phosphatase Serum, Alanine Aminotransferase Serum and Lactate Dehydrogenase Serum (U/L)|Alkaline phosphatase serum, Alanine Aminotransferase serum and Lactate Dehydrogenase serum after 104 weeks.|At 104 weeks|The safety analysis set included all subjects with a signed informed consent who were exposed in the extension.||U/L||Standard Deviation|Mean
759467|NCT00623194|Secondary|Laboratory Values: Sodium Serum, Potassium Serum and Haemoglobin (mmol/L)|Sodium Serum, Potassium Serum and Haemoglobin after 104 weeks.|At 104 weeks|The safety analysis set included all subjects with a signed informed consent who were exposed in the extension.||mmol/L||Standard Deviation|Mean
759468|NCT00623194|Secondary|Laboratory Values: Creatine Serum Umol/L|Creatine serum after 104 weeks.|At 104 weeks|The safety analysis set included all subjects with a signed informed consent who were exposed in the extension.||Umol/L||Standard Deviation|Mean
759469|NCT00623194|Secondary|Laboratory Values: Albumin Serum and Total Protein Serum (g/dL)|Albumin Serum and Total Protein Serum after 104 weeks.|At 104 weeks|The safety analysis set included all subjects with a signed informed consent who were exposed in the extension.||g/dL||Standard Deviation|Mean
759470|NCT00623194|Secondary|Insulin Dose|Daily insulin doses (basal (Insulin Detemir) and bolus (Insulin Aspart)) at week 104.|At 104 weeks|The safety analysis set included all subjects with a signed informed consent who were exposed in the extension.||U/kg||Standard Deviation|Mean
759471|NCT00623194|Secondary|Diabetic Ketoacidosis|Diabetic ketoacidosis requiring hospitalisation|At 104 weeks|The safety analysis set included all subjects with a signed informed consent who were exposed in the extension.||events|||Number
759472|NCT00623194|Secondary|SD-score (Z-score) for Body Weight|Standard deviation-score (SD-score) after 104 weeks. The SD-score for weight was calculated based on a British reference population from 1990. To estimate the growth of children, standardised mean weight values were calculated for each month of age and for each sex. Thus, a child with a weight equal to the mean value for its age and sex has an SD score of 0, while a child with a weight 2 SDs above the mean value for its age and sex has an SD score of +2.|At 104 weeks|The safety analysis set included all subjects with a signed informed consent who were exposed in the extension.||SD-scores||Standard Deviation|Mean
759473|NCT00623194|Secondary|BMI (Body Mass Index)|BMI (Body Mass Index) after 104 weeks.|At 104 weeks|The safety analysis set included all subjects with a signed informed consent who were exposed in the extension.||kg/m^2||Standard Deviation|Mean
759474|NCT00623194|Secondary|Hypoglycaemic Episodes|"Mild: signs/symptoms but able to treat him/herself. Moderate: signs/symptoms not able to treat him/herself. Responds to oral treatment.
Severe: signs/symptoms and unable to treat him/herself. semiconscious/unconscious/in coma +/- convulsion and may require parenteral treatment."|Weeks 0-104|The safety analysis set included all subjects with a signed informed consent who were exposed in the extension.||events|||Number
759475|NCT00623194|Secondary|Fasting Plasma Glucose Values|FPG (Fasting Plasma Glucose) values after 104 weeks.|At 104 weeks|Full analysis set 146 (100%) The full analysis set was used for efficacy analyses and included subjects with signed informed consent who had been exposed to trial drug in extension.||mmol/L||Standard Deviation|Mean
759476|NCT00623194|Secondary|Glycosylated Haemoglobin A1c (HbA1c)|Glycosylated Haemoglobin A1c (HbA1c) measured after 104 weeks.|At 104 weeks|Full analysis set 146 (100%) The full analysis set was used for efficacy analyses and included subjects with signed informed consent who had been exposed to trial drug in extension.||Percent (%) glycosylated haemoglobin||Standard Deviation|Mean
759477|NCT00623194|Secondary|Development of Insulin Detemir Specific Antibodies and Insulin Aspart Specific Antibodies|Amount of Insulin Detemir and Insulin Aspart specific antibodies in percent of total antibodies after 0, 52 and 104 weeks.|At 0, 52 and 104 weeks|The safety analysis set included all subjects with a signed informed consent who were exposed in the extension period.||Percent bound of total||Standard Error|Mean
759478|NCT00623194|Primary|Insulin Detemir-insulin Aspart Cross-reacting Antibodies|Estimated amount of bound antibodies in percent of total antibodies. The primary analysis of cross-reacting antibodies included results from blood samples taken before insulin detemir and less than 3 hours after insulin aspart injection. In addition, an analysis was done including results from samples taken before insulin detemir and less than 2.5 hours after insulin aspart injection.|week 0, 52 and 104|"Full analysis set 146 (100%), safety analysis set 146 (100%)
The full analysis set was used for efficacy analyses and included subjects with signed informed consent who had been exposed to trial drug in extension.
The safety analysis set included all subjects with a signed informed consent who were exposed in the extension."||Percent bound of total||Standard Error|Mean
759479|NCT00623233|Secondary|1-Year Overall Survival (OS) Rate|OS was measured from the date of first dose to the date of death from any cause. For each participant who was not known to have died as of the data inclusion cut-off date for a particular analysis, OS duration was censored for that analysis at the date of participant's last study contact prior to that cut-off date. The 1-year survival rate (percentage of participants who were alive at 1 year) was estimated from OS data.|Baseline to death from any cause, 1 year|The intent-to-treat (ITT) population included all enrolled participants who received at least 1 dose of study drug. Participants with events=25; censored participants=27.||percentage of participants||95% Confidence Interval|Number
759480|NCT00623233|Secondary|Number of Participants With Adverse Events (AEs); Pharmacology Toxicities|A listing of serious adverse events (SAEs) and other non-serious AEs is located in the Reported Adverse Event module.|Baseline, every cycle (every 14 days) up to 34 months|The safety population was the treated population and included all participants who received at least 1 dose of study therapy.||participants|||Number
759565|NCT00623727|Other Pre-specified|Number of Bleeds Per Year|Bleeds occurring on the same day were counted as one bleeding event. Bleeds occurring within 72 hours into the same location were also counted as one bleeding event. Number of bleeds 3 weeks after the first infusion per 12 months|up to one year|PP population||bleeds per year||Full Range|Median
759481|NCT00623233|Secondary|Overall Tumor Response Rate (ORR)|Response defined per Response Evaluation Criteria In Solid Tumors (RECIST) criteria: complete response (CR)=disappearance of all target lesions; partial response (PR)=30% decrease in sum of longest diameter of target lesions; progressive disease (PD)=20% increase in sum of longest diameter of target lesions; stable disease=small changes that do not meet above criteria. ORR=proportion of participants who achieved a confirmed best response of CR or PR (responders). ORR=number of participants with CR or PR /number of participants qualified for tumor response analysis (per protocol population).|Baseline to measured PD. Tumor assessments were performed every 8 weeks (q 8 weeks) during therapy and q 2 months during post-therapy until documented PD (up to 34 months).|The per protocol (PP) population included all intent-to-treat (ITT) participants who met the following criteria: histological or cytological diagnosis of breast cancer; presence of measurable disease at baseline per RECIST criteria; had at least 1 dose of study drug; no current systemic anti-tumor treatment other than protocol-specified therapy.||proportion of responders||95% Confidence Interval|Number
759482|NCT00623233|Primary|Progression Free Survival (PFS) Time|PFS was measured from date of first dose to first date of progressive disease (PD) or death from any cause. For each participant who was not known to have died or to have had PD as of the data inclusion cut-off date for a particular analysis, PFS duration was censored for that analysis at the date of the participant's last progression-free tumor assessment before that cut-off date.|Baseline to measured PD or death from any cause. Tumor assessments were performed every 8 weeks during therapy and every 2 months during post-therapy until documented PD (up to 34 months).|The intent-to-treat (ITT) population included all enrolled participants who received at least 1 dose of study drug. Participants with events=41; censored participants=11.||months||95% Confidence Interval|Median
759483|NCT00623428|Secondary|Number of Participants With Adverse Events (AEs)|"An AE was defined as a sign or symptom, including intercurrent illness, that occurred during the course of the clinical study after treatment had started. A related AE is an event assessed by the Investigator to be remotely, possibly, or probably related to study treatment according to criteria provided in the protocol. A severe AE was an event graded by the Investigator as incapacitating with inability to work or perform normal daily activity. A serious AE (SAE) was defined as any experience that suggests a significant hazard, contraindication, side effect or precaution. This includes any experience which was fatal; was life-threatening; required inpatient hospitalization or prolongation of an existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/ birth defect; was medically significant or required intervention to prevent one or other of the outcomes listed above."|From Week 1 through Week 72.|||participants|||Number
759484|NCT00623428|Secondary|Percentage of Participants With a Sustained Virologic Response 12 Weeks After Actual End of Treatment|Sustained virological response (SVR) is defined as a single last HCV RNA measurement <15 IU/ml (measured using the Roche COBAS AmpliPrep / COBAS TaqMan HCV Test) at 12 weeks after actual end of study treatment. For participants in the 48-week treatment group who stopped study treatment prior to Week 48 for any reason, the HCV RNA measurements 12 weeks after actual end of treatment were used in the analysis. Participants without a 12-week post treatment measurement are considered non-responders.|12 weeks after actual end of treatment (range from Week 36 to Week 60)|All randomized patients.||percentage of participants|||Number
759485|NCT00623428|Primary|Percentage of Participants With a Sustained Virologic Response 24 Weeks After Actual End of Treatment|Sustained virological response (SVR) is defined as a single last HCV RNA measurement <15 IU/ml (measured using the Roche COBAS AmpliPrep / COBAS TaqMan HCV Test) at 24 weeks after actual end of study treatment. For participants in the 48-week treatment group who stopped study treatment prior to Week 48 for any reason, the HCV RNA measurements 24 weeks after actual end of treatment were used in the analysis. Participants without a 24-week post treatment measurement are considered non-responders.|24 weeks after actual end of treatment (range from Week 48 to Week 72).|All randomized patients.||percentage of participants|||Number
759486|NCT00623428|Secondary|Percentage of Participants With Virological Relapse|"Virological relapse defined as the percentage of participants with a virological response at end of treatment but who did not have a sustained virological response 24 weeks after the end of treatment.
Virological response at end of treatment is defined as a single last HCV RNA measurement <15 IU/ml measured using the Roche COBAS AmpliPrep / COBAS TaqMan HCV Test at the day of last dose of study medication.
Sustained virological response 24 weeks after the actual treatment end (SVR24) is defined as a single last HCV RNA measurement <15 IU/ml at least 20 weeks after treatment end."|End of treatment (Weeks 24 or 48) and 24 weeks after the end of treatment (weeks 48 and 72 in each treatment group respectively).|Randomized patients with virological response at the end of treatment and at least one post-treatment HCV RNA measurement.||percentage of participants|||Number
759487|NCT00623428|Secondary|Percentage of Participants With Virological Response at End of Treatment|Virological response at the end of treatment was defined as the percentage of participants with HCV RNA <15 IU/mL as measured by the Roche COBAS AmpliPrep / COBAS TaqMan® HCV Test after the last dose of study medication.|End of Treatment (Week 24 and Week 48 for each treatment group respectively).|All randomized patients. A backward imputation approach was used when the HCV RNA measurement at end of treatment was missing and HCV RNA was <15 IU/mL at the first measurement after the end of treatment time window (the patient was regarded as having virological response at end of treatment).||percentage of participants|||Number
759488|NCT00623428|Secondary|Percentage of Participants With Virological Response 72 Weeks After Treatment Initiation|"Virological response 72 weeks after treatment initiation is defined as the percentage of participants with HCV RNA <15 IU/mL as measured by the Roche COBAS AmpliPrep / COBAS TaqMan® HCV Test at 48 weeks post completion of the 24 week treatment period and 24 weeks post completion of the 48 week treatment period.
Participants without Week 72 measurements were considered non-responders in the analysis."|Week 72|All randomized patients.||percentage of participants|||Number
759526|NCT00623506|Secondary|Quick Inventory of Depressive Symptomatology (QIDS)|The QIDS total scores range from 0 to 27. Total score is obtained by adding the scores for each of the nine symptom domains of the DSM-IV Major Depressive Disorder (MDD) criteria: depressed mood,loss of interest or pleasure,concentration/decision making,self-outlook,suicidal ideation, energy/fatigability,sleep,weight/appetite change,and psychomotor changes. Each item is rated 0-3 (0=least or no severity, 3=greatest severity).|Week 2, Week 10|22 out of 30 patients randomized completed 4 or more weeks of the study and were retained for data analysis. Statistics were completed using LOCF.||units on a scale||Standard Error|Mean
759489|NCT00623428|Primary|Percentage of Participants With a Sustained Virologic Response 24 Weeks After Scheduled Completion of Treatment|"Sustained virological response (SVR) is defined as a single last HCV RNA measurement <15 IU/ml (measured using the Roche COBAS AmpliPrep / COBAS TaqMan HCV Test) 24 weeks after scheduled treatment completion, defined as Week 44 or later for participants randomized to the 24-week treatment period or Week 68 or later for participants randomized to the 48-week treatment period.
Participants without measurements at the end of the 24-week untreated follow-up period were considered non-responders in the analysis."|24 weeks after scheduled treatment completion (approximately Week 48 for participants in the 24-week treatment group and Week 72 for participants in the 48-week treatment group.|All randomized patients.||percentage of participants|||Number
759490|NCT00623441|Primary|MACE (Major Adverse Cardiac Events)|MACE is defined as death, myocardial infarction (Q-wave and non-Q wave), emergent cardiac bypass surgery, or target lesion revascularization (repeat PTCA (Percutaneous Transluminal Coronary Angioplasty) or CABG (Coronary Artery Bypass Graft surgery))|12 Months|Intention to Treat (ITT)||Percentage of participants|||Number
759491|NCT00623467|Secondary|Diagnostic Confidence for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The investigator recorded his/her confidence in diagnosis for the unenhanced MR image set and the combined unenhanced/enhanced MR image sets. The degree of confidence was rated on a 4-point scale where 1 = not confident and 4 = very confident.|Up to 2 hours after injection of gadobutrol|FAS||scores on a scale||Standard Deviation|Mean
759492|NCT00623467|Secondary|Diagnostic Confidence for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Average Reader|The BRs recorded his/her confidence in diagnosis for the unenhanced MR image set and the combined unenhanced/enhanced MR image sets. The degree of confidence was rated on a 4-point scale where 1 = not confident and 4 = very confident. The AR score was the mean of the means of the 3 BRs.|Up to 2 hours after injection of gadobutrol|FAS||scores on a scale||Standard Deviation|Mean
759493|NCT00623467|Secondary|Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly excludes malignant lesions as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
759494|NCT00623467|Secondary|Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly detects malignant lesions as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
759495|NCT00623467|Secondary|Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) matches the standard of truth for the presence or absence of malignant lesions.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
759496|NCT00623467|Secondary|Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader|The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly excludes malignant lesions as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
759497|NCT00623467|Secondary|Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader|The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly detects malignant lesions as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
759498|NCT00623467|Secondary|Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader|The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) matches the standard of truth for the presence or absence of malignant lesions.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
759499|NCT00623467|Secondary|Specificity of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images|The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly excludes abnormal brain tissue as defined by the independent truth committee|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
759500|NCT00623467|Secondary|Sensitivity of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images|The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly detects abnormal brain tissue as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
759501|NCT00623467|Secondary|Accuracy of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images|The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) matches the standard of truth for the presence or absence of abnormal brain tissue.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
759502|NCT00623467|Secondary|Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. The accuracy of the investigator diagnoses for the combined unenhanced/gadobutrol-enhanced and the unenhanced MR images was the percentage of the exact matches with the final clinical diagnosis.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||per. of the exact diagnostic matches|||Number
759503|NCT00623467|Secondary|Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader|The majority reader diagnosis was the diagnosis provided by at least 2 of the BRs. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. The accuracy of the majority reader diagnoses for the combined unenhanced/gadobutrol-enhanced and the unenhanced MR images was the percentage of the exact matches with the final clinical diagnosis.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||per. of the exact diagnostic matches|||Number
759504|NCT00623467|Secondary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
759505|NCT00623467|Secondary|Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
759506|NCT00623467|Secondary|Scores for Contrast Enhancement for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the combined unenhanced and gadobutrol-enhanced MRIs. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. The data for contrast enhancement - gadobutrol combined was shown below.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
759507|NCT00623467|Secondary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Average Reader (AR)|The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
764976|NCT00673114|Secondary|Number of Participants With Acute or Chronic Graft-versus-host Disease (GVHD)|Acute and chronic GVHD|two years|||participants|||Number
759508|NCT00623467|Secondary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 3 (BR3)|BR3 (reader 3 of 3) evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
759509|NCT00623467|Secondary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 2 (BR2)|BR2 (reader 2 of 3) evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
759510|NCT00623467|Secondary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 1 (BR1)|BR1 (reader 1 of 3) evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
759511|NCT00623467|Secondary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Average Reader (AR)|The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
759512|NCT00623467|Secondary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 3 (BR3)|BR3 (reader 3 of 3) evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
759513|NCT00623467|Secondary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 2 (BR2)|BR2 (reader 2 of 3) evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
759514|NCT00623467|Secondary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 1 (BR1)|BR1 (reader 1 of 3) evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
759515|NCT00623467|Secondary|Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another to determine the total number of lesions.|Up to 2 hours after injection of gadobutrol|FAS||lesions||Standard Deviation|Mean
759527|NCT00623506|Secondary|Clinician Administered PTSD Scale (CAPS)|"Mean change scores (Week 2 minus Week 10) in posttraumatic stress disorder symptoms. Scores may range from 0 (no symptoms) to 136 (severe symptoms; score of 136 is based on the first 17 CAPS items administered).
A reduced CAPS score indicates a reduction in (improvement) PTSD symptoms, while an increase in CAPS score indicates an increase (worsening) in PTSD symptoms."|Week 2, Week 10|22 out of 30 patients randomized completed 4 or more weeks of the study and were retained for data analysis. Statistics were completed using LOCF.||units on a scale||Standard Error|Mean
759620|NCT00624065|Secondary|Mean Change From Baseline in Sitting Systolic Blood Pressure (sSBP) and Sitting Diastolic Blood Pressure (sDBP) at Week 6|Mean change was calculated as Week 6 values minus Baseline values.|Baseline and Week 6|ITTE||mmHg||Standard Deviation|Mean
759516|NCT00623467|Secondary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|"The clinical investigators evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible. The data for contrast enhancement - unenhanced were not collected for the clinical investigators."|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
759517|NCT00623467|Primary|Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Readers|The 3 blinded readers evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another to determine the total number of lesions.|Up to 2 hours after injection of gadobutrol|FAS||lesions||Standard Deviation|Mean
759518|NCT00623467|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Average Reader (AR)|The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
759519|NCT00623467|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Blinded Reader 3 (BR3)|BR3 (reader 3 of 3) evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
759520|NCT00623467|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Blinded Reader 2 (BR2)|BR2 (reader 2 of 3) evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
759521|NCT00623467|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Blinded Reader 1 (BR1)|BR1 (reader 1 of 3) evaluated the images from the unenhanced magnetic resonance imaging (MRI) in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|The full analysis set (FAS); which used data from all participants for whom data and images were available for the unenhanced MRI and combined unenhanced and gadobutrol-enhanced MRI, excluding the sample participants (the first participant from each study site).||scores on a scale||Standard Deviation|Mean
759522|NCT00623480|Other Pre-specified|Change From Baseline to 3 Years in the Physical Functioning Domain of the Haemo-QoL-A|The Haemo-QoL-A total score as well as each of its domains have a range between 0 (worst Quality of Life) and 100 (best Quality of Life) points. Therefore, a higher Haemo-QoL-A score denotes greater Quality of Life.|Baseline and 3 years|Full Analysis Set||Scores on a scale||95% Confidence Interval|Least Squares Mean
759523|NCT00623480|Secondary|Change From Baseline to 3 Years in the Colorado Adult Joint Assessment Scale|The total joint score is derived for each of six joints: left and right sides for knees (score: 0-25), ankles (score: 0-25), and elbows (score: 0-21). Higher CAJAS (Colorado Adult Joint Assessment Scale) score denotes greater joint structure damage thus a positive change from baseline means worsening. CAJAS total score is the sum of all 6 joints, ranging from 0 (best possible outcome) to 142 (worst possible outcome).|Baseline and 3 years|Full Analysis Set||Scores on a scale||95% Confidence Interval|Least Squares Mean
759524|NCT00623480|Secondary|Change From Baseline to 3 Years in the MRI (Magnetic Resonance Imaging) Scale.|The Extended MRI Scale total score has a range between 0 (normal unaffected joint) to 45 (maximal joint damage) points. It is composed of 2 domains, the soft tissue domain with a maximum of 9 points and the osteochondral domain with a maximum of 36 points. A single score for each subject was to be calculated from the sum of both domains and the average over all joints for the Extended MRI endpoint. Higher MRI score denotes greater joint structure damage thus a positive change from baseline means worsening.|Baseline and 3 years|Full Analysis Set||Scores on a scale||95% Confidence Interval|Least Squares Mean
759525|NCT00623480|Primary|Bleeding Frequency (Number of Total Bleeds)||After the last enrolled patient has been in the study for 1 year. At the cut-off, the median follow-up duration was 616 days (minimum was 111 days and maximum was 1109 days)|ITT (Intent-to-treat) Population||Bleeds||Full Range|Median
761296|NCT00638963|Secondary|Number of Days With Progression-free Survival (PFS)|"PFS was defined as the time interval from randomization to objective tumor progression or death from any cause.
The analysis could not be performed due to low enrollment."|24, 38, and 52 weeks||||||
759528|NCT00623506|Primary|Brief Assessment of Cognition in Affective Disorders (BAC-A)|Mean change scores (Week 2 minus Week 10) to assess cognitive changes. The BAC-A includes brief assessments of executive functions, verbal fluency, attention, verbal memory, working memory and motor speed. Z-scores are calculated from composite scores. Higher z-scores are indicative of better cognitive performance, lower z-scores are indicative of lower cognitive performance. Range of z-scores anticipated to be between -3 and 3. Mean change scores from week 2 and week 10 (Week 2 minus Week 10).|Week 2, Week 10|22 out of 30 patients randomized completed 4 or more weeks of the study and were retained for data analysis. Statistics were completed using Last Observation Carried Forward (LOCF).||units on a scale||Standard Error|Mean
759529|NCT00623545|Secondary|Weight Loss After Administration of Exenatide.|Body weight after overnight fast in light clothing|3 months|||kg||Standard Deviation|Mean
759530|NCT00623545|Primary|Change in Energy Intake Measured Before Treatment and at the End of Treatment.|Energy intake is as calculated from energy expenditure as measured by doubly labeled water and change in body energy stores before and at the end of treatment. Units are kcal/d.|3 months|Those that completed baseline and final measurements.||kcal/d||Standard Deviation|Mean
759531|NCT00623597|Primary|Change In Hematuria, Glycosuria And Proteinuria From Baseline|Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Day 1), Week 24 and Week 48|The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.||[0 to 4+]||Standard Deviation|Mean
759532|NCT00623597|Primary|Change In Blood Urea Nitrogen (BUN), Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL Cholesterol), Triglycerides, Calcium, Potassium, Sodium, Chloride, Phosphate, Fasting Glucose From Baseline|Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Day 1), Week 24 and Week 48|The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.||mmol/L||Standard Deviation|Mean
759533|NCT00623597|Primary|Change In Total Bilirubin, Creatinine, Uric Acid From Baseline|Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Day 1), Week 24 and Week 48|The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.||umol/L||Standard Deviation|Mean
759534|NCT00623597|Primary|Change In Creatine Kinase (CK), Serum Glutamic Oxaloacetic Transaminase (SGOT), Alkaline Phosphatase (ALP), Serum Glutamic-Pyruvic Transaminase (SGPT), Gamma-Glutamyl Transferase (GGT) Counts From Baseline|Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Day 1), Week 24 and Week 48|The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.||U/L||Standard Deviation|Mean
759535|NCT00623597|Primary|Change In Red Blood Cell (RBC) Counts From Baseline|Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Day 1), Week 24 and Week 48|The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.||10*12/L||Standard Deviation|Mean
759536|NCT00623597|Primary|Change In White Blood Cell (WBC), Platelet, Basophil, Lymphocyte, Monocyte, Neutrophil And Eosinophil Cell Counts From Baseline|Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Day 1), Week 24 and Week 48|The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.||10*9/L||Standard Deviation|Mean
759537|NCT00623597|Primary|Change In Hemoglobin, Total Protein And Total Albumin From Baseline|Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Day 1), Week 24 and Week 48|The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.||g/L||Standard Deviation|Mean
759538|NCT00623597|Secondary|Change From Baseline in Cluster Differentiation Antigen 8 (CD8) Lymphocyte Count|Change from baseline in CD8+ lymphocyte count at 24 weeks and 48 weeks were presented by age group. Change from baseline in CD8+ lymphocyte count was derived as follows: Change from baseline = (CD8+ count at week 24/48) – (CD8+ count at baseline). A baseline collection was made if there was not already a value available taken within the previous 4 weeks. Baseline was on Day 1.|Baseline (Day 1), Weeks 8, 12, 24, 36, and 48 or upon premature discontinuation|The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.||count/uL||Standard Deviation|Mean
759539|NCT00623597|Secondary|Change From Baseline in Cluster Differentiation Antigen 4 (CD4) Lymphocyte Count|Change from Baseline in CD4+ lymphocyte count at 24 weeks and 48 weeks were presented by age group. Change from baseline in CD4+ lymphocyte count was derived as follows: Change from baseline = (CD4+ count at week 24/48) – (CD4+ count at baseline). A baseline collection was made if there was not already a value available taken within the previous 4 weeks. Baseline was on Day 1.|Baseline (Day 1), Weeks 8, 12, 24, 36, and 48 or upon premature discontinuation|The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.||count/uL||Standard Deviation|Mean
759540|NCT00623597|Secondary|Number of Participants With Virological Failure|Virological failure was defined as: viral load >= 400 copies/mL on two consecutive occasions (missing visits was assumed to be above 400 copies/mL). The number of participants classified as virological failure by Age Group and viral load (≤ 10,000 copies, >10,000 copies) were presented.|From Week 12 till Week 48|The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.||participants|||Number
759541|NCT00623597|Secondary|Number of Participants With >1 Log Decrease From Baseline in Human Immunodeficiency Virus (HIV) –Ribonucleic Acid (RNA )|The number of participants experiencing a greater than 1 log drop from baseline (day 1) (log 10 transformed) were reported|From Week 8 till Week 48|The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.||participants|||Number
759563|NCT00623727|Other Pre-specified|Total rFVIII Consumption Per Year|Total number of units per kg of study medication (rFVIII) administered to participant for one year. rFVIII is recombinant factor VIII, factor VIII is functional coagulation factor|up to one year|ITT population||IU per kg||Full Range|Median
759542|NCT00623597|Secondary|Number of Participants With Human Immunodeficiency Virus (HIV) –Ribonucleic Acid (RNA) <50 Copies/mL|The number of participants with HIV-1 RNA results <50 copies/mL were reported.|Baseline (Day 1), Weeks 8, 12, 24, 36, and 48 (or upon premature discontinuation); a baseline collection was made if there was not already a value available taken within the previous 4 weeks.|The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.||participants|||Number
759543|NCT00623597|Secondary|Number of Participants With Human Immunodeficiency Virus (HIV) –Ribonucleic Acid (RNA) <400 Copies/mL|The number of participants with HIV-1 RNA results <400 copies/mL were reported|Baseline (Day 1), Weeks 8, 12, 24, 36, and 48 (or upon premature discontinuation); a baseline collection was made if there was not already a value available taken within the previous 4 weeks.|The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.||participants|||Number
759544|NCT00623597|Secondary|Change From Baseline in Mean Human Immunodeficiency Virus Viral Load|Change from baseline in plasma HIV-1 RNA was derived as Change from baseline = Log10 (HIV-1 RNA at week x) – Log10 (HIV-1 RNA at baseline)|Baseline (Day 1), Weeks 8, 12, 24, 36, and 48 (or upon premature discontinuation); a baseline collection was made if there was not already a value available taken within the previous 4 weeks.|The Safety Analysis Population (SAP) comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.||log10 copies/mL||Standard Deviation|Mean
759545|NCT00623597|Secondary|Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to Twelve Hours (AUC0-12h) for Ritonavir|The area under the plasma concentration-time curve from time zero to twelve hours (AUC0-12h) is area under the plasma concentration-time curve from time zero through actual tlast. The area under the plasma concentration-time curve from time zero to twelve hours of ritonasvir was normalized to a dose of 100 mg/kg.|Pre-dose and 3, 4, 8, 12 hours (post-dose) on Day 14 (± 2 days), or Day 28(+ 2 days) for patients switching from an NNRTI containing regimen).|The PKP population comprised all the participants from whom blood samples for pharmacokinetic analysis were collected. Participants could be excluded from the PKP if no reliable PK parameters could be determined or if justified by circumstances (e.g. vomiting after drug administration) and in agreement with the sponsor.||h*ug/mL||Standard Deviation|Mean
759546|NCT00623597|Secondary|Maximum Observed Concentration (Cmax) for Saquinavir and Ritonavir|The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration. Cmax was normalized to a dose of 50 mg/kg for Saquinavir and100 mg/kg for Ritonavir.|Pre-dose and 3, 4, 8, 12 hours (post-dose) on Day 14 (± 2 days), or Day 28(+ 2 days) for patients switching from an NNRTI containing regimen and at Week 24|The PKP population comprised all the participants from whom blood samples for pharmacokinetic analysis were collected. Participants could be excluded from the PKP if no reliable PK parameters could be determined or if justified by circumstances (e.g. vomiting after drug administration) and in agreement with the sponsor.||ng/mL||Standard Deviation|Mean
759547|NCT00623597|Secondary|Plasma Trough Concentrations (Ctrough) for Ritonavir|Plasma trough concentration is the average steady state concentration prior to morning and evening dose. Ctrough of Ritonavir was normalized to a dose of 100 mg/kg.|Pre-dose at Weeks 8, 12, 24|The PKP population comprised all the participants from whom blood samples for pharmacokinetic analysis were collected. Participants could be excluded from the PKP if no reliable PK parameters could be determined or if justified by circumstances (e.g. vomiting after drug administration) and in agreement with the sponsor.||ng/mL||Standard Deviation|Mean
759548|NCT00623597|Primary|Change In Hematocrit From Baseline|Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Day 1), Week 24 and Week 48|The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.||fraction||Standard Deviation|Mean
759549|NCT00623597|Primary|Incidence of Adverse Events (AE) and Serious Adverse Events (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes|From Baseline (Day 1) till Week 48 and Follow-up (Week 52)|The Safety Analysis Population (SAP) comprised all participants who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.||participants|||Number
759550|NCT00623597|Primary|Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to Twelve Hours (AUC0-12h) for Saquinavir|The area under the plasma concentration-time curve from time zero to twelve hours (AUC0-12h) is area under the plasma concentration-time curve from time zero through actual tlast. The area under the plasma concentration-time curve from time zero to twelve hours of saquinavir was normalized to a dose of 50 mg/kg.|Pre-dose and 3, 4, 8, 12 hours (post-dose) on Day 14 (± 2 days), or Day 28(+ 2 days) for patients switching from an Non-nucleoside reverse transcriptase inhibitor [NNRTI] containing regimen).|The pharmacokinetics Analysis Population (PKP) comprised all the participants from whom blood samples for pharmacokinetic analysis were collected. Participants could be excluded from the PKP if no reliable PK parameters could be determined or if justified by circumstances (e.g. vomiting after drug administration) and in agreement with the sponsor.||h*ug/mL||Standard Deviation|Mean
759551|NCT00623597|Primary|Plasma Trough Concentrations (Ctrough) for Saquinavir|Plasma trough concentration is the average steady state concentration prior to morning and evening dose. Ctrough of Saquinavir was normalized to a dose of 50 mg/kg.|Pre-dose at Weeks 8, 12, 24.|The pharmacokinetics Analysis Population (PKP) comprised all the participants from whom blood samples for pharmacokinetic analysis were collected. Participants could be excluded from the PKP if no reliable PK parameters could be determined or if justified by circumstances (e.g. vomiting after drug administration) and in agreement with the sponsor.||ng/mL||Standard Deviation|Mean
759564|NCT00623727|Other Pre-specified|Percentage of Bleeds Treated by Various Numbers of Injections|Bleeds occurring on the same day were counted as one bleeding event. Bleeds occurring within 72 hours into the same location were also counted as one bleeding event.|up to one year|PP Population||percentage of bleeds|||Number
759552|NCT00623636|Secondary|Number of Subjects With Pain Relief at 10 Minutes|"Pain Relief at 10 minutes was defined as a change in rating from severe or moderate (score 3 or 2) to none or mild (score 0 or 1) at the 10 minute time point and no use of rescue medication from the time of first dose to 2 hours.
The 4-point scale from the International Headache Society was used:
0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities"|2 hours from time of first dose|mITT population was defined as all randomized subjects who reported a qualifying migraine and received at least one dose of study treatment, and had at least one post-treatment efficacy evaluation.||participants|||Number
759553|NCT00623636|Secondary|Number of Subjects With Pain Relief at 4 Hours|"Pain Relief at 4 hours was defined as a change in rating from severe or moderate (score 3 or 2) to none or mild (score 0 or 1) at the 4-hour time point and no use of rescue medication from the time of first dose to 4 hours.
The 4-point scale from the International Headache Society was used:
0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities"|4 hours from time of first dose|mITT population was defined as all randomized subjects who reported a qualifying migraine and received at least one dose of study treatment, and had at least one post-treatment efficacy evaluation.||participants|||Number
759554|NCT00623636|Secondary|Number of Subjects Whose Time to Pain Relief Occurred Within 2 Hours|"The number of subjects who reported pain relief (score of 0 or 1) at any time within the 2 hours following the time of first dose and who did not use rescue medication on or prior to this point. Subjects who did not reach pain relief by the end of the time period were not included.
The 4-point scale from the International Headache Society was used: 0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities"|2 hours from the first dose|mITT population was defined as all randomized subjects who reported a qualifying migraine and received at least one dose of study treatment, and had at least one post-treatment efficacy evaluation.||participants|||Number
759555|NCT00623636|Secondary|Number of Subjects With Sustained Pain Relief From 2 to 24 Hours|"Sustained Pain Relief was defined as a rating of none or mild (score 0 or 1) at the 2-hour time point that was maintained during the 2-24 hour post-dose period and no use of rescue medication from the time of first dose to 24 hours.
The 4-point scale from the International Headache Society was used:
0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities"|From 2 to 24 hours from time of first dose|mITT population was defined as all randomized subjects who reported a qualifying migraine and received at least one dose of study treatment, and had at least one post-treatment efficacy evaluation.||participants|||Number
759556|NCT00623636|Primary|Number of Subjects Nausea Free at 2 Hours From Time of First Dose|"Nausea free was defined as a rating of none (score 0) at the 2-hour time point and no usage of rescue medications from the time of first dose to 2 hours post-dose.
The 4-point scale from the International Headache Society was used:
0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities"|2 hours from time of first dose|mITT population was defined as all randomized subjects who reported a qualifying migraine and received at least one dose of study treatment, and had at least one post-treatment efficacy evaluation.||participants|||Number
759557|NCT00623636|Primary|Number of Subjects Phonophobia Free at 2 Hours From Time of First Dose|"Phonophobia free at 2 hours was defined as a rating of none (score 0) at the 2-hour time point and no usage of rescue medications from the time of first dose to 2 hours.
The 4-point scale from the International Headache Society was used:
0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities"|2 hours from time of first dose|mITT population was defined as all randomized subjects who reported a qualifying migraine and received at least one dose of study treatment, and had at least one post-treatment efficacy evaluation.||participants|||Number
759558|NCT00623636|Primary|Number of Subjects Photophobia Free at 2 Hours From Time of First Dose|"Photophobia free at 2 hours was defined as a rating of none (score 0) at the 2-hour time point and no usage of rescue medications from the time of first dose to 2 hours.
The 4-point scale from the International Headache Society was used:
0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities"|2 hours from time of first dose|mITT population was defined as all randomized subjects who reported a qualifying migraine and received at least one dose of study treatment, and had at least one post-treatment efficacy evaluation.||participants|||Number
759559|NCT00623636|Primary|Number of Subjects With Pain Relief at 2 Hours From Time of First Dose|"Pain relief at 2 hours was defined as change in rating from severe or moderate (score 3 or 2) to a rating of none or mild (score 0 or 1) at the 2-hour time point and no usage of rescue medications from the time of first dose to 2 hours.
The 4-point scale from the International Headache Society was used:
0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities"|2 hours from time of first dose|mITT population was defined as all randomized subjects who reported a qualifying migraine and received at least one dose of study treatment, and had at least one post-treatment efficacy evaluation.||participants|||Number
759560|NCT00623714|Secondary|Hour 24 Fold Change From Period Baseline in Interleukin-13 (IL-13) Protein Concentration (pg/mL)||Baseline and 24 hours post allergen challenge|All Patients as Treated||pg/mL||95% Confidence Interval|Geometric Mean
759561|NCT00623714|Primary|Hour 24 Fold Change From Period Baseline in Interleukin-5 (IL-5) Protein Concentration (pg/mL)||Baseline and 24 hours post allergen challenge|All Patients as Treated||pg/mL||95% Confidence Interval|Geometric Mean
759562|NCT00623727|Other Pre-specified|Percentage of Participants With Less Than 9 Total Bleeds Per Year in the Open Label Extension Period|Bleeds occurring on the same day were counted as one bleeding event. Bleeds occurring within 72 hours into the same location were also counted as one bleeding event.|6 months after start of open label extension period|Participants who completed open label extension period||Percentage of participants|||Number
761297|NCT00638963|Primary|Percent of Participants With Recurrence of Brain Metastases|The analysis could not be performed due to low enrollment.|1 Year||||||
759566|NCT00623727|Secondary|Number of Joint Bleeds Per Participant Per Year in Responders|Bleeds occurring on the same day were counted as one bleeding event. Bleeds occurring within 72 hours into the same location were also counted as one bleeding event. Responders were the subjects with less than 9 total bleeds per year|up to one year|PP population in responders||Joint bleeds per year||Full Range|Median
759567|NCT00623727|Secondary|Percentage of Participants With Less Than 5 Joint Bleeds Per Year|Bleeds occurring on the same day were counted as one bleeding event. Bleeds occurring within 72 hours into the same location were also counted as one bleeding event.|up to one year|PP population||Percentage of participants|||Number
759568|NCT00623727|Primary|Percentage of Participants With Less Than 9 Total Bleeds Per Year|Bleeds occurring on the same day were counted as one bleeding event. Bleeds occurring within 72 hours into the same location were also counted as one bleeding event.|up to one year|Per protocol (PP) population||Percentage of participants|||Number
759876|NCT00628355|Primary|Intensity of Pain|"The pain will measured by using the visual analogue scale, that is represented by a straight line of 100mm starting at absence of pain and ending at point worst pain experienced or imagined."|immediately, 1, 3 months after treatment|||millimeters||Standard Deviation|Mean
759578|NCT00623779|Secondary|Ecarin Clotting Time (ECT)|Individual change in Ecarin clotting time (ECT) (sec) from baseline to week 4 visit for patients while on study drug (week 4 visit-baseline)|4 weeks according to protocol.(baseline to week 4 visit)|||sec||Full Range|Median
759579|NCT00623779|Secondary|Activated Partial Thromboplastin Time (APTT)|Individual change in Activated partial thromboplastin time (APTT) (sec) from baseline to week 4 visit for patients while on study drug (week 4 visit-baseline)|4 weeks according to protocol.(baseline to week 4 visit)|||sec||Full Range|Median
759580|NCT00623779|Secondary|Change in D-Dimer Level|Individual change in D-Dimer level (ng/ml) from baseline to week 4 visit for patients while on study drug (week 4 visit-baseline)|4 weeks according to protocol.(baseline to week 4 visit)|||ng/ml||Full Range|Median
759581|NCT00623779|Secondary|Plasma Concentration of AR-H067637XX (Active Metabolite)|Assessment of plasma concentration of AR-H067637XX (active metabolite) made on the week 4 visit|4 weeks after baseline according to protocol|||nmol/L||Full Range|Median
759582|NCT00623779|Secondary|Plasma Concentration of AZD0837 (Prodrug)|Assessment of plasma concentration of AZD0837 (prodrug) made on the week 4 visit|4 weeks after baseline according to protocol|||nmol/L||Full Range|Median
759583|NCT00623779|Secondary|Bilirubin|Number of patients while on study drug with Bilirubin>=2 times upper limit of normal.|24 weeks (randomisation visit to last treatment visit) according to protocol. For patients who discontinued treatment the time frame was <24 weeks. Mean number of weeks was 7 weeks (baseline to end of treatment visit)|41 + 42 + 45 participants were randomized into the study to treatment arm 1, arm 2 and arm 3 respectively. However, one of the participants randomized to arm 2 was treated according to treatment arm 3||Participants|||Number
759584|NCT00623779|Secondary|Alanine Aminotransferase (ALAT)|Number of patients while on study drug with Alanine aminotransferase (ALAT)>=3 times upper limit of normal.|24 weeks (randomisation visit to last treatment visit) according to protocol. For patients who discontinued treatment the time frame was <24 weeks. Mean number of weeks was 7 weeks (baseline to end of treatment visit)|41 + 42 + 45 participants were randomized into the study to treatment arm 1, arm 2 and arm 3 respectively. However, one of the participants randomized to arm 2 was treated according to treatment arm 3||Participants|||Number
759585|NCT00623779|Secondary|Change in Creatinine Level|Individual change in Creatinine level (umil/L) from baseline to week 4 visit for patients while on study drug (week 4 visit-baseline)|4 weeks according to protocol (randomisation visit to week 4 visit)|||umol/L||Standard Deviation|Mean
759586|NCT00623779|Secondary|Bleeding Events|Number of patients with a bleeding event while on study drug. Patients with multiple bleeding events are counted once|24 weeks (randomisation visit to last treatment visit) according to protocol. For patients who discontinued treatment the time frame was <24 weeks. Mean number of weeks was 7 weeks (baseline to end of treatment visit)|41 + 42 + 45 participants were randomized into the study to treatment arm 1, arm 2 and arm 3 respectively. However, one of the participants randomized to arm 2 was treated according to treatment arm 3||Participants|||Number
759587|NCT00623779|Primary|Compliance With Study Visits/Assessments|(number of visits attended acroos the time of study divided by the number of expected visits according to the time of entry into study)*100|28 weeks (randomisation visit to last follow up visit) according to protocol|||Percentage||Standard Deviation|Mean
759588|NCT00623779|Primary|Compliance With Study Drug|[(number of doses dispensed-number of doses returned)/number of days between visits]*100|24 weeks (randomisation visit to last treatment visit) according to protocol|||Percentage||Standard Deviation|Mean
759589|NCT00623779|Primary|Premature Discontinuation of Study Due to Any Reason|"|The premature discontinuation of study due to any reason"|28 weeks (randomisation visit to last follow up visit)|||Participants|||Number
759590|NCT00623779|Primary|Premature Discontinuation of Study Drug Due to Any Reason|The premature discontinuation of study drug due to any reason|24 weeks (randomisation visit to last treatment visit)|||Participants|||Number
759591|NCT00623779|Primary|Premature Discontinuation of Study or Study Drug Due to Any Reason|The premature discontinuation of study or study drug due to any reason|28 week (randomisation visit to last follow up visit in study) according to protocols|||Participants|||Number
759592|NCT00623805|Secondary|Percentage of Participants With a R0 Resection|An R0 resection indicates a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed.|Baseline to the end of the study (up to 4 years, 2 months)||||||
759593|NCT00623805|Secondary|Percentage of Participants With Metastatic Lesions Previously Considered Inoperable Who Became Operable and Underwent Surgery||Baseline to the end of the study (up to 4 years, 2 months)|Intent-to-treat population: All randomized participants who had at least 1 post-randomization efficacy assessment.||Percentage of participants|||Number
759594|NCT00623805|Secondary|Duration of Response|Duration of response was defined as the time from the first complete response or partial response until disease progression or death. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.|Baseline to the end of the study (up to 4 years, 2 months)||||||
759595|NCT00623805|Secondary|Time Until a Complete Response or a Partial Response|Time until a complete response or a partial response was defined as the time from the first administration of study drug until the first complete response or partial response.|Baseline to Month 13|Intent-to-treat population: All randomized participants who had at least 1 post-randomization efficacy assessment. Only participants with a complete response or a partial response were included in the analysis.||Months||Standard Deviation|Mean
759596|NCT00623805|Secondary|Percentage of Participants With a Complete Response or a Partial Response|A complete response was defined as the disappearance of all target lesions. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the Baseline sum longest diameter. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. All other lesions (or sites of disease) should be identified as non-target lesions. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.|Baseline to the end of the study (up to 4 years, 2 months)|Intent-to-treat population: All randomized participants who had at least 1 post-randomization efficacy assessment.||Percentage of participants|||Number
759597|NCT00623805|Secondary|Overall Survival|Overall survival was defined as the time from the first administration of study drug to death.|Baseline to the end of the study (up to 4 years, 2 months)|Intent-to-treat population: All randomized participants who had at least 1 post-randomization efficacy assessment.||Months||Standard Error|Mean
759598|NCT00623805|Primary|Progression-free Survival|Progression-free survival was defined as the time from the first administration of study drug to the first documented disease progression or death, whichever occurs first. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.|Baseline to the end of the study (up to 4 years, 2 months)|Intent-to-treat population: All randomized participants who had at least 1 post-randomization efficacy assessment.||Months||Standard Error|Mean
759599|NCT00623831|Secondary|Number of Participants With Best Overall Tumor Response|Tumor responses evaluated using computed tomography and categorized according to RECIST version 1.0 at pre-treatment and 4 weeks after the last dose of study treatment. Per RECIST v1.0 for target lesions and assessed by MRI: Complete Response (CR): Disappearance of all target lesions [no evidence of disease]; Partial Response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria.|Up to 3 months|The Tumor Response Analysis Set comprises all subjects who had an end-of-study tumor assessment performed.||participants|||Number
759600|NCT00623831|Secondary|Number of Participants With Serum NY-ESO-1-specific Immune Responses|Serum NY-ESO-1-specific immune responses evaluated by humoral immunity (antibodies measured by ELISA), cellular immunity (CD8+ T-cell and CD4+ T-cell measured by ELISPOT), and cytokine activation (measured by ELISA) from pre-treatment through 4 weeks after the last dose of study treatment. [Note: CD = cluster of differentiation; IFN =interferon; IL = interleukin; TNF = tumor necrosis factor]|Up to 3 months|The Immune Response Analysis Set comprises all subjects who achieved the desired pyrogenic effects.||participants|||Number
759601|NCT00623831|Primary|Number of Participants With Pyrogenicity at Each Dose Level Tested in the Intrasubject Dose Escalation Performed Over a Dose Range of 250 to 547,000 EU|Intrasubject dose escalation performed over a dose range of 250 to 547,000 EU until achievement of the desired pyrogenic effects (i.e., body temperature increase to 38°C to 39.5°C). Of note, the median pyrogenic dose was 60,800 EU.|Weeks 1 through 6|The Safety Analysis Set comprises all subjects who received at least 1 dose of study drug.||participants|||Number
759602|NCT00623831|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs)|Analysis of treatment-emergent adverse events (TEAEs) reported from clinical laboratory tests, physical examinations, and vital signs from pre-treatment through 4 weeks after the last dose of study treatment.|Up to 3 months|The Safety Analysis Set comprises all subjects who received at least 1 dose of study drug.||participants|||Number
759603|NCT00623935|Secondary|Percentage of Participants Alive at 1 Year|One of the secondary objectives was to determine overall survival for patients > 55 years in age with AML undergoing full or reduced transplant with the best available donor.|1 year|56 patients were enrolled. 54 patients were treated (one died prior to transplant, one did not undergo a transplant) and 4 patients were inevaluable (3 patients were less than 1 year post transplant at the time the abstract was written and 1 failed to engraft).||percentage of participants||95% Confidence Interval|Number
759621|NCT00624065|Primary|Number of Participants With Mean Sitting Cuff Blood Pressure <140/90 mmHg at the End of 6 Weeks of Treatment|Sitting cuff blood pressure was calculated as the mean of three measurements taken approximately 2 minutes apart, and before the morning dose.|Week 6|Intent to Treat Efficacy (ITTE) Population: all randomized participants with efficacy (vital signs) data after a minimum of 4 weeks of treatment||Participants|||Number
759604|NCT00623935|Primary|Percentage of Participants With Relapse Free Survival at 1 Year|The primary objective was to determine the 1 year relapse free survival rate (RFS) for individuals > 55 years in age with Acute myeloid leukemia (AML) in Complete Remission (CR) or Partial Remission (PR) who undergo a 7-8/8 HLA- matched unrelated donor transplant using a reduced intensity regimen.|1 year|56 patients were enrolled. 54 patients were treated (one died prior to transplant, one did not undergo a transplant) and 4 patients were inevaluable (3 patients were less than 1 year post transplant at the time the abstract was written and 1 failed to engraft).||percentage of participants||95% Confidence Interval|Number
759605|NCT00623974|Primary|Number of Patients With Success|"A patient success is defined as a normal calcium level (Ca>=8 and Ca<= 10.5) within 48 hours post-treatment initiation and a normal Ca level maintained through day 7 post-treatment initiation."|2 - 7 days post-treatment|Terminated due low accrual, none of 7 participants met eligibility criteria therefore not treated nor randomized to study arms.|||||
759606|NCT00624052|Secondary|Trough DBP Control Pre- and Post- Uptitration|The number of patients with DBP control (DBP<90 mmHg). Last trough DBP measurement before uptitration to telmisartan 80mg and amlodipine 10mg compared to first trough DBP taken after uptitration. Uptitration could be based DBP>90 or investigator opinion.|up to 34 weeks|91 is the number of patients titrated to telmisartan 80mg. To get 582 you need to consider the randomised to telmisartan 80 mg patients and those with additional antihypertensive that were on telmisartan 80mg.||patients|||Number
759607|NCT00624052|Secondary|Additional Reduction in SBP by Use of Additional Antihypertensive Therapy|Difference in trough SBP from last visit before add-on therapy and last visit during NCT00624052|up to 34 weeks|Total for the full analysis set||mmHg||Standard Deviation|Mean
759608|NCT00624052|Secondary|Additional Reduction in DBP by Use of Additional Antihypertensive Therapy|Difference in trough DBP from last visit before add-on therapy and last visit during NCT00624052|up to 34 weeks|Total for the full analysis set. Decision to treat with additional antihypertensive was at investigator discretion. Some patients may have been deemed to be at higher cardiovascular risk therefore requiring additional antihypertensive treatment||mmHg||Standard Deviation|Mean
759609|NCT00624052|Secondary|Number of Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control|The number of patients with DBP control (DBP>=90 mmHg). Last trough DBP measurement before taking additional antihypertensive compared to last trough DBP taken on treatment|up to 34 weeks|Decision to treat with additional antihypertensive was at investigator discretion. Some patients may have been deemed to be at higher cardiovascular risk therefore requiring additional antihypertensive treatment||patients|||Number
759610|NCT00624052|Secondary|Time to First Additional Antihypertensive|Time from first intake of medication to first intake of an antihypertensive other than the study drug|up to 34 weeks|The total of the number of patients in the BP normality classes. Decision to treat with additional antihypertensive was at investigator discretion. Some patients may have been deemed to be at higher cardiovascular risk therefore requiring additional antihypertensive treatment||Days||Standard Deviation|Mean
759611|NCT00624052|Secondary|Trough BP Normality Classes|The number of patients who reach predefined BP categories|End of study (34 weeks or last value on treatment)|||patients|||Number
759612|NCT00624052|Secondary|Trough Seated SBP Response|The number of patients who reach the target SBP of <140mmHg or had a reduction in SBP >= 15 mmHg|End of study (34 weeks or last value on treatment)|All patients who took at least one dose of study medication, have a trough baseline measurement (Visit 3 NCT 00553267) and at least one on treatment BP measurement 20-30 hours post dose||patients|||Number
759613|NCT00624052|Secondary|Trough Seated DBP Response|The number of patients who reach the target DBP of <90mmHg or had a reduction in DBP >= 10mmHg|End of study (34 weeks or last value on treatment)|All patients who took at least one dose of study medication, have a trough baseline measurement (Visit 3 NCT 00553267) and at least one on treatment BP measurement 20-30 hours post dose||patients|||Number
759614|NCT00624052|Secondary|Change in SBP From Last Available Trough in NCT00553267 to Last Available Trough in NCT00624052|The difference between the last available troughs represents the additional reduction in SBP in this study|Last available trough in NCT00624052 to end of study (34 weeks or last value on treatment)|All patients who took at least one dose of study medication, have a trough end of study measurement from NCT00553267 and at least one on treatment BP measurement 20-30 hours post dose||mmHg||Standard Error|Least Squares Mean
759615|NCT00624052|Secondary|Change From Baseline to End of Study in Trough Seated Systolic Blood Pressure|Change from baseline to the end of study in trough SBP. Baseline is defined as visit 3 of trial 1235.6|Baseline is defined as visit 3 of study NCT00553267 and end of study as 34 weeks or last value on treatment|All patients who took at least one dose of study medication, have a trough baseline measurement (Visit 3 NCT00553267) and at least one on treatment BP measurement 20-30 hours post dose||mmHg||Standard Error|Least Squares Mean
759616|NCT00624052|Secondary|Change in DBP From Last Available Trough in NCT00553267 to Last Available Trough in NCT00624052|The difference between the last available troughs represents the additional reduction in DBP in this study|Last available trough in NCT00553267 to end of study (34 weeks or last value on treatment)|All patients who took at least one dose of study medication, have a trough end of study measurement from NCT00553267 and at least one on treatment BP measurement 20-30 hours post dose||mmHg||Standard Error|Least Squares Mean
759617|NCT00624052|Secondary|Change From Baseline to End of Study in Trough Seated Diastolic Blood Pressure|Change from baseline to the end of study in trough DBP. Baseline is defined as visit 3 of trial 1235.6|Baseline is defined as visit 3 of study NCT00553267 and end of study as 34 weeks or last value on treatment|All patients who took at least one dose of study medication, have a trough baseline measurement (Visit 3 NCT00553267) and at least one on treatment BP measurement 20-30 hours post dose||mmHg||Standard Error|Least Squares Mean
759618|NCT00624052|Secondary|Trough Seated Systolic Blood Pressure (SBP) Control|The number of patients who reached the target SBP of >=140mmHg|End of study (34 weeks or last value on treatment)|The full analysis set of patients. All patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose||patients|||Number
759619|NCT00624052|Primary|Trough Seated Diastolic Blood Pressure (DBP) Control|The number of patients who reached the target DBP of <90mmHg|End of study (34 weeks or last value on treatment)|The full analysis set of patients. All patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose||patients|||Number
759622|NCT00624195|Primary|Neuropsychological Performance Change|The outcome measure is change in performance from baseline to 16 weeks as measured by the global deficit score (GDS). The GDS is calculated by averaging the individual deficit scores from each neurocognitive test. Deficit scores for each test were calculated from age-, education-, gender-, and ethnicity-adjusted raw scores by methods that capture unexpectedly poor performance while ignoring better than expected performance. The GDS ranges in value from 0-5; higher scores indicate poorer cognitive functioning. Subjects with scores greater than or equal to 0.5 are considered cognitively impaired.|Baseline and 16 weeks|||units on a scale||Standard Deviation|Mean
759623|NCT00624221|Secondary|Graft Dislocation||1 day to 1 month after grafting||||||
759624|NCT00624221|Secondary|Best Corrected Vision||6 months and 1 year after grafting||||||
759625|NCT00624221|Primary|Endothelial Cell Loss|Endothelial cell density was measured by specular or confocal microscopy. Percent cell loss was calculated by subtracting the graft endothelial cell density measured at 6 months from the baseline donor endothelial cell density and dividing by the baseline donor endothelial cell density then multiplying by 100.|6 months after grafting|||percentage of endothelial cell loss||Standard Deviation|Mean
759626|NCT00624234|Secondary|Neuroimaging Data|Neuroimaging data consists of functional MRI and structural MRI measures.|Collected before and after intervention||01/2018||||
759627|NCT00624234|Primary|Change From Baseline in WJ-III Basic Reading Normative Update (Woodcock Johnson Psychoeducational Battery – 3rd Edition; WJ-III NU) Standard Score at 15 Hours|This metric measures change in reading abilities, including word recognition and decoding, as assessed by standard educational assessments (Woodcock Johnson Psychoeducational Battery – 3rd Edition Normative Update; WJ-III NU). The scores are reported as change in age-normed standard scores (a change of 15 standard score points would represent a change of 1 standard deviation in the general population).The Basic Reading score is a normed composite of the WJ-III subtests Letter-Word Identification and Word Attack, representing word-level reading skill.|0 and 15 hours|||units on a scale||Standard Deviation|Mean
759628|NCT00624286|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose on Day 2|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|24 hours post-dose on Day 2|Intent-to-treat population: All randomized patients who received at least 1 dose of study drug. FEV1 data taken within 6 h of rescue medication was excluded from this analysis.||Liters||Standard Error|Least Squares Mean
759629|NCT00624286|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of the Study (Week 12 + 1 Day, Day 85)|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|24 hours post-dose at the end of the study (Week 12 + 1 day, Day 85)|Intent-to-treat population: All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).||Liters||Standard Error|Least Squares Mean
759630|NCT00624338|Secondary|Mean Cumulative Corticosteroid Dose||Randomization up to Week 52|MITT population included all the randomized participants who received study treatment.||mg||Standard Deviation|Mean
759631|NCT00624338|Secondary|Percentage of Participants Within Ordinal Response Categories for British Isles Lupus Assessment Group (BILAG) Flares|"Ordinal response categories have been defined as: 1) No BILAG A, no BILAG B, and completed treatment, 2) No BILAG A, at least 1 BILAG B during treatment period, and 3) At least 1 BILAG A during treatment period. The BILAG disease activity index evaluates SLE activity in 8 organ systems, using a separate alphabetic score (A to E) assigned to each organ system defined as follows. BILAG A: Disease sufficiently active requiring disease-modifying treatment (prednisone greater than 20 mg daily or immunosuppressants); BILAG B: Disease less active than in A, mild reversible problems requiring only symptomatic therapy such as antimalarials, NSAIDs, or prednisone less than 20 mg day; BILAG C: Stable mild disease; BILAG D: System previously affected but now inactive; BILAG E: System never involved."|Week 52|MITT population included all the randomized participants who received study treatment. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.||percentage of participants|||Number
759632|NCT00624338|Secondary|Percentage of Participants Experiencing a New Flare as Defined by BILAG Score A or B During Initial 24 Weeks|A flare was defined as having an adjudicated BILAG A or B score in any of the 8 organ systems during treatment, or imputed for participants who had premature treatment discontinuation. The BILAG disease activity index evaluates SLE activity in 8 organ systems, using a separate alphabetic score (A to E) assigned to each organ system defined as follows. BILAG A: Disease sufficiently active requiring disease-modifying treatment (prednisone greater than 20 mg daily or immunosuppressants); BILAG B: Disease less active than in “A”, mild reversible problems requiring only symptomatic therapy such as antimalarials, NSAIDs, or prednisone less than 20 mg day; BILAG C: Stable mild disease; BILAG D: System previously affected but now inactive; BILAG E: System never involved.|From screening up to Week 24|MITT population included all the randomized participants who received study treatment.||percentage of participants|||Number
759633|NCT00624338|Secondary|Time to First New Flare as Defined by BILAG Score A or B|"A flare was defined as having an adjudicated BILAG A or B score in any of the 8 organ systems during treatment. Analysis was right-censored at Week 52. The hazard ratios and 95% confidence intervals were obtained from the Cox proportional hazards model. The 25th Percentile of time to new flare was reported using Kaplan-Meier estimates (Median was not reached). The BILAG disease activity index evaluates SLE activity in 8 organ systems, using a separate alphabetic score (A to E) assigned to each organ system defined as follows. BILAG A: Disease sufficiently active requiring disease-modifying treatment (prednisone greater than 20 mg daily or immunosuppressants); BILAG B: Disease less active than in A, mild reversible problems requiring only symptomatic therapy such as antimalarials, NSAIDs, or prednisone less than 20 mg day; BILAG C: Stable mild disease; BILAG D: System previously affected but now inactive; BILAG E: System never involved."|From screening up to Week 52|MITT population included all the randomized participants who received study treatment||days||95% Confidence Interval|Number
759634|NCT00624338|Primary|Percentage of Participants Experiencing a New Flare as Defined by British Isles Lupus Assessment Group (BILAG) Score A or B|A flare was defined as having an adjudicated BILAG A or B score in any of the 8 organ systems during treatment, or imputed for participants who had premature treatment discontinuation. Discontinuations due to sponsor termination of the atacicept 150 mg group were not imputed as flares in this analysis. The BILAG disease activity index evaluates systemic lupus erythematosus (SLE) activity in 8 organ systems, using a separate alphabetic score (A to E) assigned to each organ system defined as follows. BILAG A: Disease sufficiently active requiring disease-modifying treatment (prednisone greater than 20 mg daily or immunosuppressants); BILAG B: Disease less active than in “A”, mild reversible problems requiring only symptomatic therapy such as antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), or prednisone less than 20 mg day; BILAG C: Stable mild disease; BILAG D: System previously affected but now inactive; BILAG E: System never involved.|From screening up to Week 52|Modified intent-to-treat (MITT) population included all the randomized participants who received study treatment.||percentage of participants|||Number
759635|NCT00624377|Secondary|Percentage of Participants Which Had a Reduction of Concomitant Drug Use|The Physician has been asked to record any prescribed and other medication used for COPD (at the physician discretion) at every visit.|8 weeks|"Safety population:
Safety population will be defined as all patients enrolled in the study. Safety endpoints will be analyzed based on the safety population.
Complete population:
Complete population was defined as the subjects who completed 3 visit measurements. Efficacy endpoints will be analyzed based on the completed population."||Percentage of Participants|||Number
759636|NCT00624377|Secondary|Change of Patient's Global COPD Assessment (8-point Scale) After 8-week of Treatment Grouped According to Patients Severity and Concomitant Medication With LABAs|"The extent of satisfaction with tiotropium bromide treatment was evaluated based on the changes of the Global COPD Assessment performed by the physician. This evaluation was done with the help of an 8-point scale rated from 1 (Poor) to 8 (Excellent) following the question Overall, how is the COPD of your patient?"|Baseline and 8 weeks|"Safety population:
Safety population will be defined as all patients enrolled in the study. Safety endpoints will be analyzed based on the safety population.
Complete population:
Complete population was defined as the subjects who completed 3 visit measurements. Efficacy endpoints will be analyzed based on the completed population."||Units on a Scale||Standard Deviation|Mean
759637|NCT00624377|Secondary|Change of Physician's Global COPD Assessment (8-point Scale) After 8-week of Treatment in All COPD Patients Independent of Concomitant LABA Treatment|"The extent of satisfaction with tiotropium bromide treatment was evaluated based on the changes of the Global COPD Assessment performed by the physician. This evaluation was done with the help of an 8-point scale rated from 1 (Poor) to 8 (Excellent) following the question Overall, how is the COPD of your patient?"|Baseline and 8 weeks|"Safety population:
Safety population will be defined as all patients enrolled in the study. Safety endpoints will be analyzed based on the safety population.
Complete population:
Complete population was defined as the subjects who completed 3 visit measurements. Efficacy endpoints will be analyzed based on the completed population."||Units on a Scale||Standard Deviation|Mean
759638|NCT00624377|Secondary|Change of Physician's Global COPD Assessment (8-point Scale) After 8-week of Treatment in All COPD Patients Without Concomitant LABA Treatment|"The extent of satisfaction with tiotropium bromide treatment was evaluated based on the changes of the Global COPD Assessment performed by the physician. This evaluation was done with the help of an 8-point scale rated from 1 (Poor) to 8 (Excellent) following the question Overall, how is the COPD of your patient?"|Baseline and 8 weeks|"Safety population:
Safety population will be defined as all patients enrolled in the study. Safety endpoints will be analyzed based on the safety population.
Complete population:
Complete population was defined as the subjects who completed 3 visit measurements. Efficacy endpoints will be analyzed based on the completed population."||Units on a Scale||Standard Deviation|Mean
759639|NCT00624377|Secondary|Change of Physician's Global COPD Assessment (8-point Scale) After 8-week of Treatment in Severe COPD Patients Independent of Concomitant LABA Treatment|"The extent of satisfaction with tiotropium bromide treatment was evaluated based on the changes of the Global COPD Assessment performed by the physician. This evaluation was done with the help of an 8-point scale rated from 1 (Poor) to 8 (Excellent) following the question Overall, how is the COPD of your patient?"|Baseline and 8 weeks|"Safety population:
Safety population will be defined as all patients enrolled in the study. Safety endpoints will be analyzed based on the safety population.
Complete population:
Complete population was defined as the subjects who completed 3 visit measurements. Efficacy endpoints will be analyzed based on the completed population."||Units on a Scale||Standard Deviation|Mean
759640|NCT00624377|Primary|Changes of FEV1/FVC (Forced Vital Capacity) After 8 Weeks of Treatment|FEV1/FVC (FEV1%) is the ratio of FEV1 to FVC. In healthy adults this should be approximately 75–80%. In obstructive diseases, the value often decreased (<80%, often ~45%).|Baseline and 8 weeks|"Safety population:
Safety population will be defined as all patients enrolled in the study. Safety endpoints will be analyzed based on the safety population.
Complete population:
Complete population was defined as the subjects who completed 3 visit measurements. Efficacy endpoints will be analyzed based on the completed population."||Ratio||Standard Deviation|Mean
759641|NCT00624377|Primary|Changes of FEV1 (Forced Expiratory Volume In 1 Second) After 8 Weeks of Treatment|FEV1: Average values for FEV1 in healthy people depend mainly on sex and age. Values of between 80% and 120% of the average value is considered normal. FEV1 < 80% of the predicted value in combination with an FEV1/FVC < 70% confirms the presence of airflow limitation that is not fully reversible|Baseline and 8 weeks|"Safety population:
Safety population will be defined as all patients enrolled in the study. Safety endpoints will be analyzed based on the safety population.
Complete population:
Complete population was defined as the subjects who completed 3 visit measurements. Efficacy endpoints will be analyzed based on the completed population."||liter per second||Standard Deviation|Mean
759654|NCT00624468|Secondary|Change From Baseline in Macular Thickness at 6 Millimeter (mm) Around Fovea in the Affected Eye at Weeks 12, 24 and 36|The change in macular thickness at 6 mm around fovea in the affected eye at Weeks 12, 24 and 36 was calculated as macular thickness at 6 mm in the affected eye at Weeks 12, 24 and 36 minus macular thickness at 6 mm in the affected eye at baseline, respectively.|Baseline, Weeks 12, 24 and 36|"ITT population included all randomized participants. Here, n signifies those participants who were evaluable for the specified category."||micrometer||Standard Deviation|Mean
764977|NCT00673114|Secondary|Incidence of Primary and Secondary Graft Failure|Number of participants experiencing graft failure.|100 days post transplant|||participants|||Number
759642|NCT00624377|Primary|Change of Physician's Global COPD (Chronic Obstructive Pulmonary Disease) Assessment After 8-week of Treatment Severe COPD Patients Without Concomitant LABA (Long-acting Beta Agonists) Treatment|"The extent of satisfaction with tiotropium bromide treatment was evaluated based on the changes of the Global COPD Assessment performed by the physician. This evaluation was done with the help of an 8-point scale rated from 1 (Poor) to 8 (Excellent) following the question Overall, how is the COPD of your patient?"|Baseline and 8 weeks|"Safety population:
Safety population will be defined as all patients enrolled in the study. Safety endpoints will be analyzed based on the safety population.
Complete population:
Complete population was defined as the subjects who completed 3 visit measurements. Efficacy endpoints will be analyzed based on the completed population."||Units on a Scale||Standard Deviation|Mean
759643|NCT00624416|Secondary|The Number of Subjects Elected to Have the Lipoma Removed.||After four weeks up to one year.|||participants|Participants||Number
759644|NCT00624416|Secondary|The Number of Lipoma Increased in Volume.||After four weeks of treatment up to one year.|||Lipomas|Participants||Number
759645|NCT00624416|Primary|The Average Percent Volume Reduction in the Lipoma.||Baseline and 4 weeks|||Percent Volume reduction (cc^3)|Participants|Full Range|Mean
759646|NCT00624442|Secondary|Pharmacokinetics of CK-1827452 Injection in Stable Heart Failure Patients||2 days||||||
759647|NCT00624442|Primary|Change From Baseline of Fractional Shortening at Various CK-1827452 Plasma Concentrations|Pooled analysis of the echocardiographic measure fractional shortening from echocardiograms taken at all timepoints. Fractional shortening is the percentage of change from baseline in the left ventricular cavity dimension with systole. Echocardiograms from cohorts 1,2,3,4 and 5 (564 echocardiograms) were binned into either placebo group or 1 of 6 groups based on plasma concentration of CK-1827452.|4 days|Pharmacodynamic Population. 4-way crossover design for cohorts 1-4 and 2-way crossover for cohort 5 requires multiple dosing events per participant. Also, multiple PK/PD assessments occur per dosing event.||Percentage of change||Standard Error|Least Squares Mean
759648|NCT00624442|Primary|Change From Baseline of Systolic Ejection Time at Various CK-1827452 Plasma Concentrations|Pooled analysis of the echocardiographic measure systolic ejection time from echocardiograms taken at all timepoints. The systolic ejection time is the period during which the aortic valve is open and blood is flowing across the valve. Echocardiograms from cohorts 1,2,3,4 and 5 (564 echocardiograms) were binned into either placebo group or 1 of 6 groups based on plasma concentration of CK-1827452.|4 days|Pharmacodynamic Population. 4-way crossover design for cohorts 1-4 and 2-way crossover for cohort 5 requires multiple dosing events per participant. Also, multiple PK/PD assessments occur per dosing event.||msec||Standard Error|Least Squares Mean
759649|NCT00624468|Secondary|Percentage of Participants Converting to Clinically Definite Multiple Sclerosis (CDMS) Second Clinical Attack|Conversion to CDMS was defined as experiencing a second clinical attack meeting all of the following criteria: (a) Neurological abnormality, either newly appearing or re-appearing, with abnormality specified by both (i) Neurological abnormality separated by at least 30 days from onset of a preceding clinical event, and (ii) Neurological abnormality lasting for at least 24 hours; (b) Absence of fever or known infection (fever with temperature [axillary, orally or intraauricularly] greater than 37.5 degree Celsius/99.5 degree Fahrenheit); (c) Objective neurological impairment, correlating with the participant's reported symptoms, defined as either (i) Increase in at least 1 of the functional systems of the Expanded Disability Status Score (EDSS), or (ii) Increase of the total EDSS score. EDSS assesses disability in 8 functional systems and total score ranges from 0 (normal) to 10 (death due to MS). Percentage of participants converting to CDMS (second clinical attack) was reported.|From baseline (Study Day 1) up to Week 36|ITT population included all randomized participants.||percentage of participants|||Number
759650|NCT00624468|Secondary|Contrast Sensitivity: Score Line|Contrast sensitivity was measured using the Pelli-Robson charts with letters arranged in groups of 3. Pelli-Robson chart is used for clinical measurement of contrast sensitivity and determines the contrast required to read large letters of a fixed size. The possible score line range is 0 (visual disability) to 16 (normal contrast sensitivity).|Weeks 12, 24 and 36|"ITT population included all randomized participants. Here, N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and n signifies those participants who were evaluable for the specified category."||units on a scale||Standard Deviation|Mean
759651|NCT00624468|Secondary|Contrast Sensitivity: Total Number of Letters Correctly Identified|Contrast Sensitivity was measured using the Pelli-Robson Charts. Pelli-Robson chart is used for clinical measurement of contrast sensitivity and determines the contrast required to read large letters of a fixed size. Total number of letters correctly identified in the affected and fellow eye were reported. The total possible range is 0 to 48. More the number of letters identified, better is the contrast sensitivity.|Weeks 12, 24 and 36|"ITT population included all randomized participants. Here, N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and n signifies those participants who were evaluable for the specified category."||letters||Standard Deviation|Mean
759652|NCT00624468|Secondary|Low-Contrast Letter Acuity: Total Number of Letters Correctly Identified|Low-contrast letter acuity was measured by using the Sloan Charts at 1.25 fraction (%) and 2.5%. Sloan letters are a set of optotypes used to test visual acuity. Total number of letters correctly identified in the affected and fellow eye were reported. The possible Sloan Chart range is 0 to 70. More the number of letters identified, better is the visual acuity.|Weeks 12, 24 and 36|"ITT population included all randomized participants. Here, N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and n signifies those participants who were evaluable for the specified category."||letters||Standard Deviation|Mean
759653|NCT00624468|Secondary|Change From Baseline in Macular Volume in the Affected Eye at Weeks 12, 24 and 36|The change in macular volume in the affected eye at Weeks 12, 24 and 36 was calculated as macular volume in the affected eye at Weeks 12, 24 and 36 minus macular volume in the affected eye at baseline, respectively.|Baseline, Weeks 12, 24 and 36|"ITT population included all randomized participants. Here, n signifies those participants who were evaluable for the specified category."||cubic micrometer||Standard Deviation|Mean
759754|NCT00627458|Secondary|Anti-HBs Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.|Before (Month 0) and one month after (Month 1) the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||mIU/mL||95% Confidence Interval|Geometric Mean
759655|NCT00624468|Secondary|Change From Baseline in Macular Thickness at 3 Millimeter (mm) Around Fovea in the Affected Eye at Weeks 12, 24 and 36|The change in macular thickness at 3 mm around fovea in the affected eye at Weeks 12, 24 and 36 was calculated as macular thickness at 3 mm in the affected eye at Weeks 12, 24 and 36 minus macular thickness at 3 mm in the affected eye at baseline, respectively.|Baseline, Weeks 12, 24 and 36|"ITT population included all randomized participants. Here, n signifies those participants who were evaluable for the specified category."||micrometer||Standard Deviation|Mean
759656|NCT00624468|Secondary|Change From Baseline in Retinal Nerve Fiber Layer (RNFL) Thickness in the Affected Eye at Weeks 12 and 24|The RNFL thickness was measured for 12 sectors (every 30 degrees) per eye in triplicate by OCT measurements and was then averaged over 12 sectors. The change in RNFL thickness at Weeks 12 and 24 was calculated as RNFL thickness at Weeks 12 and 24 minus RNFL thickness at baseline, respectively.|Baseline, Weeks 12 and 24|"ITT population included all randomized participants. Here, N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and n signifies those participants who were evaluable for the specified category."||micrometer||Standard Deviation|Mean
759657|NCT00624468|Secondary|Difference in Retinal Nerve Fibre Layer (RNFL) Thickness Between the Affected Eye and Fellow Eye|The RNFL thickness was measured for 12 sectors (every 30 degrees) per eye in triplicate by optical coherence tomography (OCT) measurements and was then averaged over 12 sectors. Difference was calculated as RNFL thickness in affected eye minus RNFL thickness in fellow eye.|Weeks 12, 24 and 36|"ITT population included all randomized participants. Here, N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and n signifies those participants who were evaluable for the specified category."||micrometer||Standard Error|Mean
759658|NCT00624468|Primary|Change From Baseline in Retinal Nerve Fiber Layer (RNFL) Thickness in the Affected Eye at Last Observed Value (LOV)|The RNFL thickness was measured for 12 sectors (every 30 degrees) per eye in triplicate by optical coherence tomography (OCT) measurements and were then averaged over 12 sectors. The change in RNFL thickness at LOV visit was calculated as RNFL thickness at LOV minus RNFL thickness at baseline.|Baseline, LOV (Week 48)|"ITT population included all randomized participants. Here, n signifies those participants who were evaluable for the specified category."||micrometer||Standard Deviation|Mean
759659|NCT00624520|Primary|"Mental Stress Induced Elevation in Double Product by Anger-recall Task"|"Maximum Mental Stress induced elevation in Double Product , (equal to Heart Rate , beats/minute, x Systolic Arterial Blood Pressure, mmHg), following serial heart rate and blood pressure measurements during mental stress of anger-recall task. Heart rate and blood pressure responses were recorded at 2.5 minute intervals before , during, and after each test using a Philips automated blood pressure recording device. The anger-recall test was applied for 25 minutes with 10 minutes monitoring post-test. An average of 3 measurements was taken as baseline prior to stress tasks. Stress induced double product elevations were measured as the difference between baseline and maximal values in units of mmHg.beats/minute. Higher values represent a greater mental stress induced effect, and lower values, a lower effect"|Immediate to 6 months post intervention|Response to Mental Stress by Anger-Recall Stress Task||mmHg x beats/minute||Standard Error|Mean
759660|NCT00624520|Primary|Mental Stress Induced Elevation in Double Product by Math Stress Task|"Maximum Mental Stress induced elevation in Double Product , DP, (equal to Heart Rate , beats/minute, x Systolic Arterial Blood Pressure, mmHg), following serial heart rate and blood pressure measurements during mental stress tasks of mental arithmetic (serial subtraction). Heart rate and blood pressure responses were recorded at 2.5 minute intervals before , during, and after each test using a Philips automated blood pressure recording device. The math task was applied for 10 minutes, with 10 minutes recovery time. An average of 3 measurements was taken as baseline prior to stress tasks. Stress induced double product elevations were measured as the difference between baseline and maximal values in units of mmHg.beats/minute. Higher values represent a greater mental stress induced effect, and lower values, a lower effect."|3 months post intervention|Response to mental stress by math task testing at 3 months post intervention, compared with pre-intervention. Within-group comparison is shown for matched pair data. The lower number of participants analyzed than at study entry is due to patient drop-outs during follow-up post-intervention.||mmHg x beats/minute||Standard Error|Mean
759661|NCT00624520|Secondary|Cardioverter-DefibrillatorTherapies|Cardioverter-Defibrillator therapies for treatment of serious ventricular arrhythmia|6 months post intervention|Cardioverter-defibrillator interrogation data between 3 and 6 months post intervention||percentage of participants|||Number
759662|NCT00624520|Secondary|Low Frequency/High Frequency Ratio of Heart Rate Variability|Heart Rate Variability measure of cardiac autonomic activity Data are derived from ambulatory ECG recordings during serial mental stress testing (math and anger-recall tasks) using a General Electric MARS Holter analysis system. Time series are created from beat-to-beat intervals, from which frequency domain measures are calculated. Decreased Low/High Frequency ratio reflects Increased High Frequency heart rate variability which correlates with increased cardiac parasympathetic activity, which may be beneficial in this patient population. Normalized units are used, reflecting percentage of total frequency power.|6 months post intervention|"Reduced numbers of participants analyzed reflect drop-outs or non-diagnostic recordings for heart rate variability analyses during follow-up, with inclusion only of participants having accurate and appropriate data.
Data are shown for Ratios of Low and High Frequency power shown above."||Ratio||Standard Deviation|Mean
759663|NCT00624520|Secondary|High Frequency Heart Rate Variability|Heart Rate Variability measure of Cardiac Parasympathetic activity. Data are derived from ambulatory ECG recordings during serial mental stress testing (math and anger-recall tasks) using a General Electric MARS Holter analysis system. Time series are created from beat-to-beat intervals, from which frequency domain measures are calculated. Increased High Frequency heart rate variability correlates with increased cardiac parasympathetic activity. Normalized units are used, reflecting percentage of total frequency power.|6 months post intervention|Reduced participant numbers reflect drop-outs and exclusion of participants with non-diagnostic recordings for HRV analyses, with inclusion only of participants having accurate and appropriate data.||percentage of spectral power||Standard Deviation|Mean
759755|NCT00627458|Secondary|Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.|Before (Month 0) and one month after (Month 1) the booster vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
759664|NCT00624520|Secondary|Low Frequency Heart Rate Variability|"Heart Rate Variability measure of cardiac autonomic activity, believed to reflect a combination of cardiac sympathetic and parasympathetic activity.
Data are derived from ambulatory ECG recordings during serial mental stress testing (math and anger-recall tasks) using a General Electric MARS Holter analysis system. Time series are created from beat-to-beat intervals, from which frequency domain measures are calculated. Low frequency heart rate variability correlates with cardiac sympathetic and parasympathetic activity. Increased sympathetic activity and/or decreased parasympathetic activity occur in this study population at high risk for cardiac arrhythmia. Normalized units are used, reflecting percentage of total frequency power."|6 months post intervention|6 months post intervention, from ECG recordings during mental stress tasks Reduced numbers of participants analyzed reflect drop-outs or non-diagnostic recordings for HRV analyses during follow-up, with inclusion only of participants having accurate and appropriate data.||percentage of spectral power||Standard Deviation|Mean
759665|NCT00624520|Secondary|Depression/Dejection|Psychometric score from self-report questionnaire Scale range is 9 to 60. Lower values represent better outcome, and higher values represent worse outcome..|3 months post intervention|3 months post intervention Reduced numbers of participants analyzed reflect drop-outs or failure to fully complete questionnaires during follow-up,with inclusion only of participants having accurate and appropriate data.||units on a scale||Standard Deviation|Mean
759666|NCT00624520|Secondary|Perceived Stress|Psychometric score from self-report questionnaire Scale range is 2-27. Lower values represent better outcome, and higher values represent worse outcome..|Immediate post intervention|Immediate post intervention Reduced numbers of participants analyzed reflect drop-outs or failure to fully complete questionnaires during follow-up, with inclusion only of participants having accurate and appropriate data.||units on a scale||Standard Deviation|Mean
759667|NCT00624520|Secondary|Tension/Anxiety|Psychometric score by self-report questionnaire Scale range is 3-29. Lower values represent better outcome, and higher values represent worse outcome..|Immediate post intervention|Immediate post intervention Reduced numbers of participants analyzed reflect drop-outs or failure to fully complete questionnaires during follow-up, with inclusion only of participants having accurate and appropriate data.||units on a scale||Standard Deviation|Mean
759668|NCT00624520|Secondary|State Anger|Psychosocial score of negative mood derived from self-report questionnaires. Scale range was 15-45. Lower values represent better outcome, and higher values represent worse outcome..|Immediate post intervention|Serial psychometric scores up to 6 months post intervention Reduced numbers of participants analyzed reflect drop-outs or failure to fully complete questionnaires during follow-up, with inclusion only of participants having accurate and appropriate data.||units on a scale||Standard Deviation|Mean
759669|NCT00624520|Primary|"Mental Stress Induced Elevation in Double Product by Math Stress Task"|"Maximum Mental Stress induced elevation in Double Product , (equal to Heart Rate , beats/minute, x Systolic Arterial Blood Pressure, mmHg), following serial heart rate and blood pressure measurements during mental stress task of mental arithmetic (serial subtraction). Heart rate and blood pressure responses were recorded at 2.5 minute intervals before , during, and after each test using a Philips automated blood pressure recording device. The math task was applied for 10 minutes, with 10 minutes recovery time. An average of 3 measurements was taken as baseline prior to stress tasks. Stress induced double product elevations were measured as the difference between baseline and maximal values in units of mmHg.beats/minute. Higher values represent a greater mental stress induced effect, and lower values, a lower effect."|Immediate to 6 months post intervention|Response to Mental Stress by Math Stress Task.||mmHg x beats/min||Standard Error|Mean
759670|NCT00624559|Secondary|Urinary Sodium Excretion|Urine collected over 24 hour period on last day of each different sodium diet|24 hour|||mmol Na+/24 hr||Standard Error|Mean
759671|NCT00624559|Primary|Mean Arterial Pressure|Blood pressure was measured on the last day of each 7 day sodium diet for 24 hours using an ambulatory blood pressure monitor|24 hours|||mm Hg||Standard Error|Mean
759672|NCT00624585|Secondary|Number of Participants With Stable Disease (SD)||1 Year 4 Months|All Participants||participants|||Number
759673|NCT00624585|Secondary|Number of Participants With Partial Remission (PR)|Partial remission (PR) (modified IWG); IWG = International MDS Working Group. All of the CR criteria (if abnormal prior to treatment), except: Bone marrow evaluation: Blasts decreased by ≥ 50% over pretreatment but still >5%. Cellularity and morphology are not relevant.|1 Year 4 Months|All Participants||participants|||Number
759674|NCT00624585|Secondary|Number of Participants With Hematologic Improvement|Hematologic improvement in platelets, red blood cell (RBC), neutrophils according to modified IWG Criteria; Cytogenetic response (modified IWG); Change in percentage of blasts in bone marrow and peripheral blood; Src-Tyr416 phosphorylation in medullary myeloblasts. Hematologic improvements must last ≥ 8 weeks.|1 Year 4 Months|All Participants||participants|||Number
759675|NCT00624585|Primary|Number of Participants With Marrow Complete Remission (CR)|"Complete remission (modified IWG); IWG = International MDS Working Group.
Bone Marrow Response must last ≥4 weeks. Bone marrow evaluation: Bone marrow showing ≤5% myeloblasts with normal maturation of all cell lines."|1 Year 4 Months|All Participants||participants|||Number
759676|NCT00624780|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and Week 12, for period 1, and between Week 13 and Week 24, for period 2, that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to Week 12 (period 1), Week 13 up to Week 24 (period 2)|Safety analysis set: all randomized participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable for this measure during each specified period, for each group respectively.||participants|||Number
759677|NCT00624780|Other Pre-specified|Sheehan-Suicidality Tracking Scale (S-STS) Score|Sheehan-Suicidality Tracking Scale (S-STS): an 8-item prospective rating scale that tracked treatment-emergent suicidal ideation and behaviors. Items 1a, 2-6, 7a, and 8 were scored on a 5-point Likert scale (ranging from 0= not at all to 4=extremely). Items 1, 1b, and 7 required yes or no responses. Total score ranged from 0 to 35, higher score indicated higher suicidal tendency.|Baseline up to Week 24|Data was not statistically summarized but was available in individual participant listings and mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) due to change in planned analysis.|||||
764978|NCT00673114|Secondary|Platelet Engraftment (Untransfused and Platelet Count > 50,000)|Participants platelet engrafted.|Approximately 1 year|||participants|||Number
759678|NCT00624780|Secondary|Clinical Global Impression - Improvement (CGI-I) Score at the End of Period 2|CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale.|Week 24|Per-protocol analysis set: all randomized participants who had baseline with at least 1 discontinuation or efficacy visit, and were not major protocol violators. LOCF method was used to impute missing values.||units on a scale||Standard Deviation|Mean
759679|NCT00624780|Secondary|Clinical Global Impression - Improvement (CGI-I) Score at the End of Period 1|CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale.|Week 12|Per-protocol analysis set: all randomized participants who had baseline with at least 1 discontinuation or efficacy visit, and were not major protocol violators. LOCF method was used to impute missing values.||units on a scale||Standard Deviation|Mean
759680|NCT00624780|Secondary|Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 24|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected|Baseline, Week 24|Per-protocol analysis set: all randomized participants who had baseline with at least 1 discontinuation or efficacy visit, and were not major protocol violators. LOCF method was used to impute missing values.||units on a scale||Standard Deviation|Mean
759681|NCT00624780|Secondary|Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 12|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected.|Baseline, Week 12|Per-protocol analysis set: all randomized participants who had baseline with at least 1 discontinuation or efficacy visit, and were not major protocol violators. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. LOCF method was used to impute missing values.||units on a scale||Standard Deviation|Mean
759682|NCT00624780|Secondary|Clinical Global Impression - Severity (CGI-S) Score for Period 2|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected|Baseline, Week 24|Per-protocol analysis set: all randomized participants who had baseline with at least 1 discontinuation or efficacy visit, and were not major protocol violators. LOCF method was used to impute missing values.||units on a scale||Standard Deviation|Mean
759683|NCT00624780|Secondary|Clinical Global Impression - Severity (CGI-S) Score for Period 1|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected.|Baseline, Week 12|Per-protocol analysis set: all randomized participants who had baseline with at least 1 discontinuation or efficacy visit, and were not major protocol violators. LOCF method was used to impute missing values.||units on a scale||Standard Deviation|Mean
759684|NCT00624780|Secondary|Change From Baseline in Hamilton Anxiety Scale (HAM-A) Score at Week 24|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.|Baseline, Week 24|Per-protocol analysis set: all randomized participants who had baseline with at least 1 discontinuation or efficacy visit, and were not major protocol violators. LOCF method was used to impute missing values.||units on a scale||Standard Deviation|Mean
759685|NCT00624780|Secondary|Change From Baseline in Hamilton Anxiety Scale (HAM-A) Score at Week 12|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.|Baseline, Week 12|Per-protocol analysis set: all randomized participants who had baseline with at least 1 discontinuation or efficacy visit, and were not major protocol violators. LOCF method was used to impute missing values. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
759686|NCT00624780|Secondary|Hamilton Anxiety Scale (HAM-A) Score for Period 2|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.|Baseline, Week 24|Per-protocol analysis set: all randomized participants who had baseline with at least 1 discontinuation or efficacy visit, and were not major protocol violators. LOCF method was used to impute missing values.||units on a scale||Standard Deviation|Mean
759687|NCT00624780|Secondary|Hamilton Anxiety Scale (HAM-A) Score for Period 1|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.|Baseline, Week 12|Per-protocol analysis set: all randomized participants who had baseline with at least 1 discontinuation or efficacy visit, and were not major protocol violators. Last observation carried forward (LOCF) method was used to impute missing values.||units on a scale||Standard Deviation|Mean
759688|NCT00624780|Secondary|Hamilton Anxiety Scale (HAM-A) Score for Cohort 3 (6-Month Last Visit)|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.|Week 1, 2 post-treatment discontinuation (discontinuation [DC] occurred after Week 15 to Week 24)|Per-protocol analysis set. Cohort 3: Participants who discontinued study after Week 15 or completed Week 24 visit and had at least 1 discontinuation assessment were included. N (Number of Participants Analyzed) = participants evaluable for this measure. ‘n’ = participants evaluable at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
759689|NCT00624780|Secondary|Hamilton Anxiety Scale (HAM-A) for Cohort 2 (3-Month Last Visit)|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); possible range 0 to 56. Lower score indicates less affected.|Week 1, 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)|Per-protocol analysis set. Cohort 2: Participants who discontinued study from Week 9 to Week 15 and had at least 1 discontinuation assessment were included in Month 3 last visit analysis. N (Number of Participants Analyzed) = participants evaluable for this measure. ‘n’ = participants evaluable at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
764979|NCT00673114|Secondary|Non-Relapse Mortality at 180 Days Post Transplant||180 days|||participants|||Number
759690|NCT00624780|Secondary|Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit)|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.|Week 1, 2 post-treatment discontinuation (discontinuation occurred prior to Week 9)|Per-protocol analysis set. Cohort 1: Participants who discontinued study prior to Week 9 and had at least 1 discontinuation assessment were included in less-than Month 3 last visit analysis. N (Number of Participants Analyzed) = participants evaluable for this measure. ‘n’ = participants evaluable at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
759691|NCT00624780|Secondary|Change From Last Visit of Treatment in Hamilton Anxiety Scale (HAM-A) for Cohort 3 (6-Month Last Visit) at Discontinuation Week 1 and 2|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.|Last visit on treatment, Week 1, 2 post-treatment discontinuation (discontinuation [DC] occurred after Week 15 to Week 24)|Per-protocol analysis set. Cohort 3: Participants who discontinued study after Week 15 or completed Week 24 visit and had at least 1 discontinuation assessment were included. N(Number of Participants Analyzed) = participants evaluable for this measure. ‘n’ = participants evaluable at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
759692|NCT00624780|Secondary|Change From Last Visit of Treatment in Hamilton Anxiety Scale (HAM-A) for Cohort 2 (3-Month Last Visit) at Discontinuation Week 1 and 2|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); possible range 0 to 56. Lower score indicates less affected.|Last visit on treatment, Week 1, 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)|Per-protocol analysis set. Cohort 2: Participants who discontinued study from Week 9 to Week 15 and had at least 1 discontinuation assessment were included in Month 3 last visit analysis. N (Number of Participants Analyzed) = participants evaluable for this measure. ‘n’ = participants evaluable at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
759693|NCT00624780|Secondary|Change From Last Visit of Treatment in Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 1 and 2|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.|Last visit on treatment, Week 1, 2 post-treatment discontinuation (discontinuation occurred prior to Week 9)|Per-protocol analysis set. Cohort 1: Participants who discontinued study prior to Week 9 and had at least 1 discontinuation assessment were included in less-than Month 3 last visit analysis. N (Number of Participants Analyzed) = participants evaluable for this measure. ‘n’ = participants evaluable at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
759694|NCT00624780|Secondary|Physician's Withdrawal Checklist (PWC) Score for Cohort 3 (6-Month Last Visit)|PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.|Week 1, 2 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)|Per-protocol analysis set. Cohort 3: Participants who discontinued study after Week 15 or completed Week 24 visit and had at least 1 discontinuation assessment were included. N (Number of Participants Analyzed) = participants evaluable for this measure. ‘n’ = participants evaluable at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
759695|NCT00624780|Secondary|Physician's Withdrawal Checklist (PWC) Score for Cohort 2 (3-Month Last Visit)|PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.|Week 1, 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)|Per-protocol analysis set. Cohort 2: Participants who discontinued study from Week 9 to Week 15 and had at least 1 discontinuation assessment were included in Month 3 last visit analysis. N (Number of Participants Analyzed) = participants evaluable for this measure. ‘n’ = participants evaluable at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
759696|NCT00624780|Secondary|Physician's Withdrawal Checklist (PWC) Score for Cohort 1 (Less Than 3-Month Last Visit)|PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.|Week 1, 2 post-treatment discontinuation (discontinuation occurred prior to Week 9)|Per-protocol analysis set. Cohort 1: Participants who discontinued study prior to Week 9 and had at least 1 discontinuation assessment were included in less-than Month 3 last visit analysis. N (Number of Participants Analyzed) = participants evaluable for this measure. ‘n’ = participants evaluable at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
759697|NCT00624780|Secondary|Change From Baseline in Physician's Withdrawal Checklist (PWC) Score for Cohort 3 (6-Month Last Visit) at Discontinuation Week 1 and 2|PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.|Baseline, Week 1, 2 post-treatment discontinuation (discontinuation [DC] occurred after Week 15 to Week 24)|Per-protocol analysis set. Cohort 3: Participants who discontinued study after Week 15 or completed Week 24 visit and had at least 1 discontinuation assessment were included. N (Number of Participants Analyzed) = participants evaluable for this measure. ‘n’=participants evaluable at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
759716|NCT00624780|Primary|Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 2|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.|Baseline, Week 2 post-treatment discontinuation (discontinuation occurred prior to Week 9)|Per-protocol analysis set. Cohort 1: Participants who discontinued study prior to Week 9 and had at least 1 discontinuation assessment were included in less-than Month 3 last visit analysis. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
759698|NCT00624780|Secondary|Change From Baseline in Physician's Withdrawal Checklist (PWC) Score for Cohort 2 (3-Month Last Visit) at Discontinuation Week 1 and 2|PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.|Baseline, Week 1, 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)|Per-protocol analysis set. Cohort 2: Participants who discontinued study from Week 9 to Week 15 and had at least 1 discontinuation assessment were included in Month 3 last visit analysis. N (Number of Participants Analyzed) = participants evaluable for this measure. ‘n’ = participants evaluable at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
759699|NCT00624780|Secondary|Change From Baseline in Physician's Withdrawal Checklist (PWC) Score for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 1 and 2|PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.|Baseline, Week 1, 2 post-treatment discontinuation (discontinuation occurred prior to Week 9)|Per-protocol analysis set. Cohort 1: Participants who discontinued study prior to Week 9 and had at least 1 discontinuation assessment were included in less-than Month 3 last visit analysis. N (Number of Participants Analyzed) = participants evaluable for this measure. ‘n’ = participants evaluable at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
759700|NCT00624780|Secondary|Number of Participants With Discontinuation-Emergent Signs and Symptoms (DESS) for Cohort 3 (6-Month Last Visit)|DESS adverse events, a subset of Treatment Emergent Signs and Symptoms (TESS), were defined as those spontaneously reported adverse events that developed or existed prior to but worsened during Discontinuation Week 1 and 2.|2 weeks post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)|Per-protocol analysis set. Cohort 3: Participants who discontinued study after Week 15 or completed Week 24 visit and had at least 1 discontinuation assessment were included in Month 6 last visit analysis.||participants|||Number
759701|NCT00624780|Secondary|Number of Participants With Discontinuation-Emergent Signs and Symptoms (DESS) for Cohort 2 (3-Month Last Visit)|DESS adverse events, a subset of Treatment Emergent Signs and Symptoms (TESS), were defined as those spontaneously reported adverse events that developed or existed prior to but worsened during Discontinuation Week 1 and 2.|2 weeks post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)|Per-protocol analysis set. Cohort 1: Participants who discontinued study from Week 9 to Week 15 and had at least 1 discontinuation assessment were included in Month 3 last visit analysis.||participants|||Number
759702|NCT00624780|Secondary|Number of Participants With Discontinuation-Emergent Signs and Symptoms (DESS) for Cohort 1 (Less Than 3-Month Last Visit)|DESS adverse events, a subset of Treatment Emergent Signs and Symptoms (TESS), were defined as those spontaneously reported adverse events that developed or existed prior to but worsened during Discontinuation Week 1 and 2.|2 weeks post-treatment discontinuation (discontinuation occurred prior to Week 9)|Per-protocol analysis set. Cohort 1: Participants who discontinued study prior to Week 9 and had at least 1 discontinuation assessment were included in less-than Month 3 last visit analysis.||participants|||Number
759703|NCT00624780|Secondary|Number of Participants With Rebound Anxiety for Cohort 3 (6-Month Last Visit)|Rebound anxiety was defined as a rapid return of the participant’s original symptoms following drug discontinuation, that were worse compared to baseline. This was characterized by a HAM-A score at the Discontinuation Week 1 or Week 2 greater than or equal to the baseline value.|2 weeks post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)|Per-protocol analysis set. Cohort 3: Participants who discontinued study after Week 15 or completed Week 24 visit and had at least 1 discontinuation assessment were included in Month 6 last visit analysis. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||participants|||Number
759704|NCT00624780|Secondary|Number of Participants With Rebound Anxiety for Cohort 2 (3-Month Last Visit)|Rebound anxiety was defined as a rapid return of the participant’s original symptoms following drug discontinuation, that were worse compared to baseline. This was characterized by a HAM-A score at the Discontinuation Week 1 or Week 2 greater than or equal to the baseline value.|2 weeks post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)|Per-protocol analysis set. Cohort 2: Participants who discontinued study from Week 9 to Week 15 and had at least 1 discontinuation assessment were included in Month 3 last visit analysis. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||participants|||Number
759705|NCT00624780|Secondary|Number of Participants With Rebound Anxiety for Cohort 1 (Less Than 3-Month Last Visit)|Rebound anxiety was defined as a rapid return of the participant’s original symptoms following drug discontinuation, that were worse compared to baseline. This was characterized by a HAM-A score at the Discontinuation Week 1 or Week 2 greater than or equal to the baseline value.|2 weeks post-treatment discontinuation (discontinuation occurred prior to Week 9)|Per-protocol analysis set. Cohort 1: Participants who discontinued study prior to Week 9 and had at least 1 discontinuation assessment were included in less-than Month 3 last visit analysis. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||participants|||Number
759706|NCT00624780|Primary|Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 3 (6-Month Last Visit) at Discontinuation Week 2|PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.|Last visit on treatment, Week 2 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)|Per-protocol analysis set. Cohort 3: Participants who discontinued study after Week 15 or completed Week 24 visit and had at least 1 discontinuation assessment were included in Month 6 last visit analysis. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
759752|NCT00627458|Secondary|Anti-PRP Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in µg/mL.|Before (Month 0) and one month after (Month 1) the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||µg/mL||95% Confidence Interval|Geometric Mean
759707|NCT00624780|Primary|Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 3 (6-Month Last Visit) at Discontinuation Week 1|PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.|Last visit on treatment, Week 1 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)|Per-protocol analysis set. Cohort 3: Participants who discontinued study after Week 15 or completed Week 24 visit and had at least 1 discontinuation assessment were included in Month 6 last visit analysis. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
759708|NCT00624780|Primary|Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 2 (3-Month Last Visit) at Discontinuation Week 2|PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.|Last visit on treatment, Week 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)|Per-protocol analysis set. Cohort 2: Participants who discontinued study from Week 9 to Week 15 and had at least 1 discontinuation assessment were included in Month 3 last visit analysis. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
759709|NCT00624780|Primary|Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 2 (3-Month Last Visit) at Discontinuation Week 1|PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.|Last visit on treatment, Week 1 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)|Per-protocol analysis set. Cohort 2: Participants who discontinued study from Week 9 to Week 15 and had at least 1 discontinuation assessment were included in Month 3 last visit analysis. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
759710|NCT00624780|Primary|Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 2|PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.|Last visit on treatment, Week 2 post-treatment discontinuation (discontinuation occurred prior to Week 9)|Per-protocol analysis set. Cohort 1: Participants who discontinued study prior to Week 9 and had at least 1 discontinuation assessment were included in less-than Month 3 last visit analysis. Here, N (Number of Participants Analyzed) signifies those participants evaluable for this measure.||units on a scale||Standard Deviation|Mean
759711|NCT00624780|Primary|Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 1|PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.|Last visit on treatment, Week 1 post-treatment discontinuation (discontinuation occurred prior to Week 9)|Per-protocol analysis set. Cohort 1: Participants who discontinued study prior to Week 9 and had at least 1 discontinuation assessment were included in less-than Month 3 last visit analysis. N (Number of Participants Analyzed) = participants evaluable for this measure. ‘n’ = participants evaluable at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
759712|NCT00624780|Primary|Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 3 (6-Month Last Visit) at Discontinuation Week 2|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); possible range 0 to 56. Lower score indicates less affected.|Baseline, Week 2 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)|Per-protocol analysis set. Cohort 3: Participants who discontinued study after Week 15 or completed Week 24 visit and had at least 1 discontinuation assessment were included in Month 6 last visit analysis. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
759713|NCT00624780|Primary|Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 3 (6-Month Last Visit) at Discontinuation Week 1|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.|Baseline, Week 1 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)|Per-protocol analysis set: all randomized participants who had baseline with at least 1 discontinuation or efficacy visit, and were not major protocol violators. Cohort 3: Participants who discontinued study after Week 15 or completed Week 24 visit and had at least 1 discontinuation assessment were included in Month 6 last visit analysis.||units on a scale||Standard Deviation|Mean
759714|NCT00624780|Primary|Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 2 (3-Month Last Visit) at Discontinuation Week 2|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.|Baseline, Week 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)|Per-protocol analysis set. Cohort 2: Participants who discontinued study from Week 9 to Week 15 and had at least 1 discontinuation assessment were included in Month 3 last visit analysis. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
759715|NCT00624780|Primary|Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 2 (3-Month Last Visit) at Discontinuation Week 1|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.|Baseline, Week 1 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)|Per-protocol analysis set: all randomized participants who had baseline with at least 1 discontinuation or efficacy visit, and were not major protocol violators. Cohort 2: Participants who discontinued study from Week 9 to Week 15 and had at least 1 discontinuation assessment were included in Month 3 last visit analysis.||units on a scale||Standard Deviation|Mean
759717|NCT00624780|Primary|Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 1|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.|Baseline, Week 1 post-treatment discontinuation (discontinuation occurred prior to Week 9)|Per-protocol analysis set: all randomized participants who had baseline with at least 1 discontinuation or efficacy visit, and were not major protocol violators. Cohort 1: Participants who discontinued study prior to Week 9 and had at least 1 discontinuation assessment were included. n=participants evaluable at given time points for each group.||units on a scale||Standard Deviation|Mean
759718|NCT00624806|Primary|Percent of Participant Triggering DMP Items|Percent of participants who triggered Disease-Management Protocol items by group.|Enrollment to study end, 8 weeks|||% of participants triggering an item|Participants||Number
759719|NCT00624806|Primary|Number of Days With Triggers at Certain Timeframe|Measured the number of days with triggers that occurred on the Baseline day, during the 8-week intervention, and on the End of Study day.|Enrollment to study end, 8 weeks|||days|Participants||Number
759720|NCT00624806|Primary|Days of Data|Data includes the number of triggered items and types of triggers.|Enrollment to study end, 8 weeks|||days||Full Range|Mean
759721|NCT00624832|Secondary|Late Phase Allergic Response After Treatment With Study Drug in Active and Placebo Patients|"Late-phase allergic response (LAR) was only determined for those patients who had an LAR >= 15% at baseline allergen bronchoprovocation testing. For Forced Expiratory Volume, FEV1 (0), the best post saline (Control) FEV1 was used. LAR (%) = 100*[FEV1 (0) - Minimum FEV1 (3-8h)]/FEV1 (0)."|Week 0, Week 8 and Week 16|Safety and Pharmacodynamic (PD) population. Although all patients had baseline EAR not all of them had a value determined for week 8 and 16 reducing the number evaluable for analysis particularly at week 8. Patients of first 2 Xolair groups received placebo treatment were pooled in one placebo group for analysis. No analysis on third Xolair groups.||Percentage of LAR||Standard Deviation|Mean
759722|NCT00624832|Primary|Early Phase Allergic Response After Treatment With Study Drug in Active and Placebo Patients|"The EAR was defined as the maximum percent drop in forced expiratory volume in one second (FEV1) in the first 30 minutes after the challenge:
EAR = 100* [ FEV1 (0) - Minimum FEV1 (10, 15, 30 min)] / FEV1 (0). For FEV1 (0), the ”best post saline (Control) FEV1” was used. The EAR was analyzed using a linear (ANCOVA) model with a fixed effect for treatment groups and the EAR from the baseline challenge was used as a covariate."|Week 8, Week 16|Safety and Pharmacodynamic (PD) population. Although all patients had baseline EAR not all of them had a value determined for week 8 and 16 reducing the number evaluable for analysis particularly at week 8. Patients of first 2 Xolair groups received placebo treatment were pooled in one placebo group for analysis. No analysis on third Xolair groups.||Percentage of EAR||Standard Error|Least Squares Mean
759723|NCT00627393|Secondary|Discontinuation of Granulocyte Transfusions Due to Toxicity or Intolerance||Measured through Day 42||||||
759724|NCT00627393|Secondary|Evaluation of Granulocyte Yield||Measured immediately after each granulocyte donation|||Granulocyte Yield (billion cells/liter)|Participants|Inter-Quartile Range|Median
759725|NCT00627393|Secondary|Donor Availability (Proportion of Scheduled Granulocyte Transfusion Days on Which Granulocytes Were Available)||Measured through study completion|The unit of analysis is patient-days where a granulocyte transfusion was scheduled.||percentage of available granulocyte days|Participants||Number
759726|NCT00627393|Secondary|Serious Adverse Events in Granulocyte Donors||Measured at Week 1 after G-CSF administration|237 subjects consented to G-CSF and dexamethasone administration prior to granulocyte donation.||participants|||Number
759727|NCT00627393|Secondary|Long-term Survival||Measured at Month 3|All randomized subjects.||participants|||Number
759728|NCT00627393|Secondary|Time to Negative Blood Culture for Participants With Positive Blood Culture at Baseline||Measured through Day 42||||||
759729|NCT00627393|Secondary|Time to Negative Test for Fungal Antigenemia (e.g., Galactomannan Antigenemia Among Participants With Invasive Aspergillosis)||Measured at Days 7, 14, and 42||||||
759730|NCT00627393|Secondary|Fever Resolution|Fever resolution between the two treatment groups was compared using Gray's model that takes into account death as a competing risk.|Measured through Day 42|Subjects who had fever at baseline.||proportion of subjects, resolved fever|||Number
759731|NCT00627393|Secondary|Overall Incidence of Adverse Effects||Measured through Day 42|All randomized subjects.||participants|||Number
759732|NCT00627393|Secondary|Graft Versus Host Disease Among Recipients of Allogeneic Stem Cell Transplantation|Time to GVHD incidence between the two treatment groups was compared using Gray's model that takes into account death as a competing risk.|Measured at Day 42|Subjects who had allogeneic stem cell transplantation||proportion of subjects, GVHD incidnence|||Number
759733|NCT00627393|Secondary|Serious Granulocyte Transfusion Reactions, Including Febrile, Allergic, and Pulmonary Reactions (Transfusion Arm Only)||Measured within 6 hours after end of transfusion|Subjects who received granulocyte transfusions. Six subjects in the control group received granulocyte transfusions in violation of the protocol.||participants|||Number
759734|NCT00627393|Secondary|Alloimmunization, Defined as the Appearance of Anti-human Leukocyte Antigen (HLA) or Antineutrophil Antibodies||Measured at Days 14 and 42||||||
759735|NCT00627393|Primary|Percentage of Participants Who Are Alive at 42 Days After Treatment and Have Had Microbial Response|"Microbial response was defined as follows:
A negative blood culture test at 42 days after randomization for subjects with fungemia (candidemia or fusariosis) or bacteremia.
Improvement of signs and symptoms of infectious disease (complete or partial response) at 42 days after randomization."|Measured at Day 42|All adjudicated or deceased subjects in intention-to-treat analyses.||percentage of participants|||Number
759736|NCT00627406|Secondary|Pregnancy Rate||from stimulation day 1 until last ultrasound scan 7 weeks after a positive pregnancy test|||participants|||Number
759737|NCT00627406|Primary|Frequency of Moderate to Severe OHSS.||From the date of triggering ovulation until 2 weeks after pregnancy test. group C and D. 12 days after pregnancy test|No power calculation was proformed.||participants|||Number
759753|NCT00627458|Secondary|Anti-poliovirus Type 1, 2 and 3 Antibody Titers|Antibody titers were presented as geometric mean titers (GMTs).|Before (Month 0) and one month after (Month 1) the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||Titers||95% Confidence Interval|Geometric Mean
759738|NCT00627445|Secondary|Number of Nocturnal Hypoglycaemic Episodes|Number of nocturnal hypoglycaemic episodes occurring after baseline (week 0) to end of treatment (week 16) in each treatment group. Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no plasma glucose or blood glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L or 56 mg/dL.|weeks 0-16|Intention-to-Treat analysis set (ITT) is all randomised subjects exposed to at least one dose of trial product.||episodes|||Number
759739|NCT00627445|Secondary|Number of Hypoglycaemic Episodes|Number of hypoglycaemic episodes occurring after baseline (week 0) to the end of treatment (week 16) in each treatment group. Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no plasma glucose or blood glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L or 56 mg/dL.|weeks 0-16|Intention-to-Treat analysis set (ITT) is all randomised subjects exposed to at least one dose of trial product.||episodes|||Number
759740|NCT00627445|Secondary|Change in Body Weight|Change in body weight from baseline (week 0) to end of treatment (week 16)|week 0, week 16|Intention-to-Treat analysis set (ITT) is all randomised subjects exposed to at least one dose of trial product.||kg||Standard Error|Least Squares Mean
759741|NCT00627445|Secondary|The Total Increase in Total Daily Insulin Dose Per Body Weight|The total increase in total daily insulin dose per body weight from baseline (week 0) to end of treatment (week 16).|week 0, week 16|Intention-to-Treat analysis set (ITT) is all randomised subjects exposed to at least one dose of trial product.||U/kg||Standard Error|Least Squares Mean
759742|NCT00627445|Secondary|Change and Daily Average in Prandial Plasma Glucose Increment|Change in prandial (mealtime) plasma glucose increment from baseline (week 0) to end of treatment (week 16). Daily average prandial plasma glucose increment was calculated at end of treatment.|week 0, week 16|Intention-to-Treat analysis set (ITT) using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to at least one dose of trial product.||mmol/L||Standard Error|Least Squares Mean
759743|NCT00627445|Secondary|Change and Daily Average in 8-point Plasma Glucose|Change in 8-point plasma glucose from baseline (week 0) to at end of treatment (week 16). 8-point plasma glucose was measured at following time points: Before each meal, 120 minutes after the start of each meal, at bedtime, and at 3:00 AM in the morning. Daily average was calculated at the end of treatment.|week 0, week 16|Intention-to-Treat analysis set (ITT) using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to at least one dose of trial product.||mmol/L||Standard Error|Least Squares Mean
759744|NCT00627445|Secondary|The Percentage of Subjects Achieving HbA1c Treatment Targets|The percentage of subjects who after 16 weeks of treatment met the glycosylated haemoglobin A1c (HbA1c) treatment targets below 7%, or below or equal to 6.5%.|week 16|Intention-to-Treat analysis set (ITT) using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to at least one dose of trial product.||percentage (%) of subjects|||Number
759745|NCT00627445|Primary|Change in Glycosylated Haemoglobin A1c (HbA1c)|Change in glycosylated haemoglobin A1c (HbA1c) from week 0 (baseline) to end of treatment (week 16)|week 0, week 16|Intention-to-Treat analysis set (ITT) using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to at least one dose of trial product.||percentage (%) of total haemoglobin||Standard Error|Least Squares Mean
759746|NCT00627458|Secondary|Number of Subjects Reporting Concomitant Medications||During the 4-day (Days 0-3) follow-up period after the booster vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.||Participants|||Count of Participants
759747|NCT00627458|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Assessed SAEs include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Month 0 to Month 1, during the entire study period|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.||Participants|||Count of Participants
759748|NCT00627458|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Day 0–30) follow-up period after the booster vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.||Participants|||Count of Participants
759749|NCT00627458|Secondary|Number of Subjects With Any Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, fever [defined as rectal temperature equal to or above (≥) 38.0 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade.|During the 4-day (Days 0–3) follow-up period after the booster vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with their symptoms sheet filled in.||Participants|||Count of Participants
759750|NCT00627458|Secondary|Number of Subjects With Any Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.|During the 4-day (Days 0–3) follow-up period after the booster vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with their symptoms sheet filled in.||Participants|||Count of Participants
759751|NCT00627458|Secondary|Number of Subjects With a Vaccine Response to PT, FHA and PR|Vaccine response was defined as the appearance of antibodies in subjects who were initially seronegative (i.e. with concentrations < cut-off value) or at least doubling of pre-vaccination antibody concentrations in subjects who were initially seropositive (i.e. with concentrations > cut-off value).|One month after the booster dose (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||Participants|||Count of Participants
759756|NCT00627458|Secondary|Anti-D and Anti-T Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.|Before (Month 0) and one month after (Month 1) the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||IU/mL||95% Confidence Interval|Geometric Mean
759757|NCT00627458|Secondary|Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP)|A seroprotected subject was defined as a subject with anti-PRP antibody concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL.|Before (Month 0) and one month after (Month 1) the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||Participants|||Count of Participants
759758|NCT00627458|Secondary|Number of Seroprotected Subjects Against PT, FHA and PRN|A seroprotected subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL .|Before (Month 0) and one month after (Month 1) the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||Participants|||Count of Participants
759759|NCT00627458|Secondary|Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3|A seroprotected subject was defined as a subject with anti-polio 1, 2 and 3 antibody titers ≥ the value of 8.|Before (Month 0) and one month after (Month 1) the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||Participants|||Count of Participants
759760|NCT00627458|Secondary|Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)|A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL and ≥ 100 mIU/mL.|Before (Month 0) and one month after (Month 1) the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||Participants|||Count of Participants
759761|NCT00627458|Secondary|Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids|A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.1 IU/mL .|Before (Month 0) and one month after (Month 1) the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||Participants|||Count of Participants
759762|NCT00627458|Primary|Anti-PRP Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in µg/mL.|One month after the booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||µg/mL||95% Confidence Interval|Geometric Mean
759763|NCT00627458|Primary|Anti-PRP Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (µg/mL).|Before the booster vaccination (At Month 0)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||µg/mL||95% Confidence Interval|Geometric Mean
759764|NCT00627458|Primary|Anti-poliovirus Type 1, Type 2 and Type 3 Antibody Titers|Antibody titers were presented as geometric mean titers (GMTs).|One month after the booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||Titers||95% Confidence Interval|Geometric Mean
759765|NCT00627458|Primary|Anti-poliovirus Type 1, Type 2 and Type 3 Antibody Titers|Antibody titers were presented as geometric mean titers (GMTs).|Before the booster vaccination (At Month 0)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||Titers||95% Confidence Interval|Geometric Mean
759766|NCT00627458|Primary|Anti-HBs Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.|One month after the booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||mIU/mL||95% Confidence Interval|Geometric Mean
759767|NCT00627458|Primary|Anti-HBs Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.|Before the booster vaccination (At Month 0)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||mIU/mL||95% Confidence Interval|Geometric Mean
759768|NCT00627458|Primary|Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.|One month after the booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
759769|NCT00627458|Primary|Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.|Before the booster vaccination (At Month 0)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
759770|NCT00627458|Primary|Anti-D and Anti-T Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.|One month after the booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||IU/mL||95% Confidence Interval|Geometric Mean
759771|NCT00627458|Primary|Anti-D and Anti-T Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.|Before the booster vaccination (At Month 0)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||IU/mL||95% Confidence Interval|Geometric Mean
764980|NCT00673114|Secondary|180 Day Survival|Number of participants alive at 180 days post transplant|180 days|||participants|||Number
759772|NCT00627458|Primary|Number of Subjects With a Vaccine Response to PT, FHA and PR|Vaccine response was defined as the appearance of antibodies in subjects who were initially seronegative [i.e. with concentrations lower than (<) the cut-off value] or at least doubling of pre-vaccination antibody concentrations in subjects who were initially seropositive [i.e. with concentrations greater than (>) the cut-off value).|One month after the booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||Participants|||Count of Participants
759773|NCT00627458|Primary|Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP)|A seroprotected subject was defined as a subject with anti-PRP antibody concentrations ≥ 0.15 µg/mL and ≥ 1.0 µg/mL.|One month after the booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||Participants|||Count of Participants
759774|NCT00627458|Primary|Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP)|A seroprotected subject was defined as a subject with anti-PRP antibody concentrations greater than or equal to (≥) 0.15 micrograms per milliliter (µg/mL) and ≥ 1.0 µg/mL.|Before the booster vaccination (At Month 0)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||Participants|||Count of Participants
759775|NCT00627458|Primary|Number of Seroprotected Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)|A seroprotected subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL.|One month after the booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||Participants|||Count of Participants
759776|NCT00627458|Primary|Number of Seroprotected Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)|A seroprotected subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).|Before the booster vaccination (At Month 0)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||Participants|||Count of Participants
759777|NCT00627458|Primary|Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3|A seroprotected subject was defined as a subject with anti-Polio 1, 2 and 3 antibody titers ≥ the value of 8.|One month after the booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||Participants|||Count of Participants
759778|NCT00627458|Primary|Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3|A seroprotected subject was defined as a subject with anti-Polio 1, 2 and 3 antibody titers ≥ the value of 8.|Before the booster vaccination (At Month 0)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||Participants|||Count of Participants
759779|NCT00627458|Primary|Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)|A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL and ≥ 100 mIU/mL.|One month after the booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||Participants|||Count of Participants
759780|NCT00627458|Primary|Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)|A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 milli international units per milliliter (mIU/mL) and ≥ 100 mIU/mL.|Before the booster vaccination (At Month 0)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||Participants|||Count of Participants
759781|NCT00627458|Primary|Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids|A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 IU/mL.|One month after the booster vaccination (At Month 1)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||Participants|||Count of Participants
759782|NCT00627458|Primary|Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids|A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).|Before the booster administration (At Month 0)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||Participants|||Count of Participants
759783|NCT00627497|Secondary|Hospital Stay||At the time of discharge|||days||Standard Deviation|Mean
759784|NCT00627497|Secondary|Blood Loss||At the time of operation|||ml||Standard Deviation|Mean
759785|NCT00627497|Secondary|Operative Time||at the time of operation|||hrs||Standard Deviation|Mean
759786|NCT00627497|Secondary|Success Rate of SF-36 Health Survey|Success rate of SF-36 Health Survey include two components: the success rate of a physical component summary (PCS) and the success rate of a mental component summary (MCS). The success rates of SF-36 PCS and MCS for DIAM Device vs. Single-Level Posterior Decompression were defined as: (Post Score - Pre Score) / Pre Score>= 20%. The success rates of SF-36 PCS and MCS for DIAM vs. Posterolateral Interbody Fusion were defined as: Post Score - Pre Score >= 0.|24 month after operation|||percentage of participants|||Number
759787|NCT00627497|Secondary|General Health Status (SF-36)|The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results are summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS and MCS is between 0 and 100, with higher scores denoting better quality of life.|24 month after operation|||Scores on a scale||Standard Deviation|Mean
759788|NCT00627497|Secondary|Leg Pain Success Rate|Leg pain success rate is reported as the percentage of participants whose leg pain improvement met: (Pre Score - Post Score)/ Pre Score > 20%.|24 month after operation|||percentage of participant|||Number
759789|NCT00627497|Secondary|Leg Pain|Numerical rating scales are used to evaluate leg intensity and frequency. Patients will rate their pain intensity on a scale from 0-10, with a score of 0 representing “no pain” and a score of 10 representing “pain as bad as it could be.” Similarly, patients will record their back pain frequency on a scale from 0-10, with a score of 0 being “pain none of the time” and a score of 10 being “pain all of the time.” A patient’s total pain score will be the sum of pain intensity and frequency scores (0 min, 20 max).|24 month after operation|||units on a scale||Standard Deviation|Mean
759790|NCT00627497|Secondary|Back Pain Success Rate|Back pain success rate is reported as the percentage of participants whose back pain improvement met: (Pre Score - Post Score)/ Pre Score > 20%.|24 month after operation|||percentage of participants|||Number
759791|NCT00627497|Secondary|Back Pain|Numerical rating scales are used to evaluate back pain intensity and frequency. Patients will rate their pain intensity on a scale from 0-10, with a score of 0 representing “no pain” and a score of 10 representing “pain as bad as it could be.” Similarly, patients will record their back pain frequency on a scale from 0-10, with a score of 0 being “pain none of the time” and a score of 10 being “pain all of the time.” A patient’s total pain score will be the sum of pain intensity and frequency scores (0 min, 20 max).|24 month after operation|||units on a scale||Standard Deviation|Mean
759792|NCT00627497|Secondary|Success Rate of Neurological Status|Success rate of neurological status is reported as the percentage of participants who met neurological success defined as maintenance or improvement in all sections (motor, sensory, reflex, and straight leg raising) for the time period evaluated. In order for a section to be considered a success, each element in the section must remain the same or improve from the time of the preoperative evaluation to the time period evaluated.|24 month after operation|||percentage of particpants|||Number
759793|NCT00627497|Secondary|Success Rate of Oswestry Diability Index Scores|Success rate of Oswestry Diability Index Scores is reported as the percentage of participants who met: Pre-treatment Score – Post-treatment Score ≥ 15.|24 month after operation|||percentage of participants|||Number
759794|NCT00627497|Secondary|Oswestry Disability Index (ODI) Score|The self-administered Oswestry Disability Index (ODI) Questionnaire was used to assess patient pain and ability to function. The ODI scale ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability).|24 month after operation|||Scores on a scale||Standard Deviation|Mean
759795|NCT00627497|Primary|Rate of Overall Success|"Rate of overall success is reported as the percentage of partipants who met all of the following criteria:
Pain/disability (ODI) success:(Success of ODI is defined as pain/disability improvement according to the definition: Pre-treatment Score – Post-treatment Score ≥ 15);
Neurological success (Neurological success is defined as maintenance or improvement in sections of motor, sensory, reflex, and straight leg raise for the time period evaluated);
No serious adverse event classified as “surgical treatment associated”;
No additional surgical procedure classified as “failure.”"|24 months after operation|||percentage of patients|||Number
759796|NCT00627523|Secondary|Change From Baseline in Body Mass Index (BMI) at Months 3, 6, 12, 18, and 24.|Body mass index was calculated for all visits by means of the following formula: BMI (kg/m2) = Weight (kg)/(Height[m])2. The change from Baseline BMI was calculated as the difference between the parameter values at each visit, and the Baseline parameter values.|Baseline, Months 3, 6, 12, 18, and 24|Full Analysis Set (FAS) included participants who were randomized to treatment and completed at least one post-baseline efficacy measure. One participant was randomized to Genotropin® but did not receive any treatment. This participant was excluded from FAS but included in Control group for safety analysis.||Kg/m2||Standard Deviation|Mean
759797|NCT00627523|Secondary|Change From Baseline in Body Weight at Months 3, 6, 12, 18, and 24.|Body weight was measured at all the relevant visits. The change from Baseline in body weight was calculated as the difference between the parameter values at each visit, and the Baseline parameter values.|Baseline, Months 3, 6, 12, 18, and 24|Full Analysis Set (FAS) included participants who were randomized to treatment and completed at least one post-baseline efficacy measure. One participant was randomized to Genotropin® but did not receive any treatment. This participant was excluded from FAS but included in Control group for safety analysis.||Kg||Standard Deviation|Mean
759798|NCT00627523|Secondary|Change From Baseline in Head Circumference SDS at Months 3, 6, 12, 18 and 24.|Head circumference SDS was calculated by means of the following formula = (Participant head circumference)–(Normal head circumference)/Normal head circumference standard deviation. Where participant head circumference refers to the participant's head circumference at the relevant visit, and normal head circumference and the normal head circumference standard deviation equals the population mean and standard deviation values for participants of a similar age and gender. A negative score indicated a participant had a smaller head circumference for their age/gender.|Baseline, Months 3, 6, 12, 18 and 24.|Full Analysis Set (FAS) included participants who were randomized to treatment and completed at least one post-baseline efficacy measure. One participant was randomized to Genotropin® but did not receive any treatment. This participant was excluded from FAS but included in Control group for safety analysis.||SDS||Standard Deviation|Mean
759799|NCT00627523|Secondary|Head Circumference SDS at Months 3, 6, 12, 18 and 24.|Head circumference SDS was calculated by means of the following formula = (Participant head circumference)–(Normal head circumference)/ Normal head circumference standard deviation. Where participant head circumference refers to the participant's head circumference at the relevant visit, and normal head circumference and the normal head circumference standard deviation equals the population mean and standard deviation values for participants of a similar age and gender. A negative score indicated a participant had a smaller head circumference for their age/gender.|Months 3, 6, 12, 18 and 24|Full Analysis Set (FAS) included participants who were randomized to treatment and completed at least one post-baseline efficacy measure. One participant was randomized to Genotropin® but did not receive any treatment. This participant was excluded from FAS but included in Control group for safety analysis.||SDS||Standard Deviation|Mean
759807|NCT00627679|Primary|AUC(0-inf) of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010|The AUC(0-inf) is the area under the plot of plasma concentration of drug against time to infinity (inf) after drug administration. Budesonide AUC(0-inf) is reported in picograms times minutes per milliliter (pg*min/ml).|8 hours|Patients with available data at specified time points are included in the analysis population.||pg*min/mL||Standard Deviation|Mean
764981|NCT00673114|Primary|The Number of Participants Reaching Primary Endpoint of Absolute Neutrophil Count (ANC) of 500/uL (Engraftment).||By day 100|||participants|||Number
759800|NCT00627523|Secondary|Change From Baseline in Psychomotor Development Using the Psychomotor Development Index (PDI) of Bayley Scale at Month 12.|BSID-II measured the mental and psychomotor development and test behavior of participants from 1 to 42 months of age. The scale was used to describe the current developmental functioning of infants and to assist in diagnosis and treatment planning for infants with developmental delays or disabilities. The BSID-II provided the psychomotor raw score which was used to calculate the PDI score. Possible PDI scores ranged from 50-150. A score of 69 and below indicates significantly delayed performance, 70 to 84 indicates mildly delayed performance, 85 to 114 indicates normal limits and 115 and above indicates accelerated performance.|Baseline and Month 12|Full Analysis Set (FAS) included participants who were randomized to treatment and completed at least one post-baseline efficacy measure. One participant was randomized to Genotropin® but did not receive any treatment. This participant was excluded from FAS but included in Control group for safety analysis.||Units on a scale||Standard Error|Least Squares Mean
759801|NCT00627523|Secondary|Change From Baseline in Mental Development Using the Mental Development Index (MDI) of Bayley Scale at Month 12.|The Bayley Scale of Infant Development (BSID-II) measured the mental and psychomotor development and test behavior of participants from 1 to 42 months of age. The scale was used to describe the current developmental functioning of infants and to assist in diagnosis and treatment planning for infants with developmental delays or disabilities. The BSID-II provided the mental raw score which was used to calculate the MDI score. Possible MDI scores ranged from 50-150. A score of 69 and below indicates significantly delayed performance, 70 to 84 indicates mildly delayed performance, 85 to 114 indicates normal limits and 115 and above indicates accelerated performance.|Baseline and Month 12|Full Analysis Set (FAS) included participants who were randomized to treatment and completed at least one post-baseline efficacy measure. One participant was randomized to Genotropin® but did not receive any treatment. This participant was excluded from FAS but included in Control group for safety analysis.||Units on a scale||Standard Error|Least Squares Mean
759802|NCT00627523|Secondary|Change From Baseline in Growth Velocity SDS at Month 12.|The growth velocity SDS was calculated at the relevant visit by means of the following formula: Growth velocity SDS = (participant growth velocity) – (normal growth velocity)/normal growth velocity standard deviation. Where, participant growth velocity refers to the participant’s growth velocity at the relevant visit, and normal growth velocity and the normal growth velocity standard deviation equals the population mean and standard deviation values for participants of a similar age and gender. The change from Baseline value for growth velocity SDS was calculated as the difference between the parameter values at a specific visit, and the Baseline parameter values. A negative score indicated that a participant had slower growth for their age/gender.|Baseline and Month 12|Full Analysis Set (FAS) included participants who were randomized to treatment and completed at least one post-baseline efficacy measure. Missing values were imputed using LOCF method. One participant was randomized to Genotropin® but did not receive any treatment. This participant was excluded from FAS but included in Control for safety analysis.||SDS||Standard Error|Least Squares Mean
759803|NCT00627523|Secondary|Change From Baseline in Height SDS at Month 12.|Height SDS was calculated at the relevant visit by means of the following formula: Height SDS = (participant height) - (normal height)/normal height standard deviation. Where participant height refers to the participant’s height at the relevant visit, and normal height and the normal height standard deviation equals the population mean and standard deviation values for participants of a similar age and gender. The change from Baseline value for height SDS was calculated as the difference between the parameter values at a specific visit, and the Baseline parameter values. The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender.|Baseline and Month 12|Full Analysis Set (FAS) included participants who were randomized to treatment and completed at least one post-baseline efficacy measure. Missing values were imputed using LOCF method. One participant was randomized to Genotropin® but did not receive any treatment. This participant was excluded from FAS but included in Control for safety analysis.||SDS||Standard Error|Least Squares Mean
759804|NCT00627523|Secondary|Change From Baseline in Growth Velocity SDS at Month 24.|The growth velocity SDS was calculated at the relevant visit by means of the following formula: Growth velocity SDS = (participant growth velocity) – (normal growth velocity)/normal growth velocity standard deviation. Where, participant growth velocity refers to the participant’s growth velocity at the relevant visit, and normal growth velocity and the normal growth velocity standard deviation equals the population mean and standard deviation values for participants of a similar age and gender. The change from Baseline value for growth velocity SDS was calculated as the difference between the parameter values at a specific visit, and the Baseline parameter values. A negative score indicated that a participant had slower growth for their age/gender.|Baseline and Month 24|Full Analysis Set (FAS) included participants who were randomized to treatment and completed at least one post-baseline efficacy measure. Missing values were imputed using LOCF method. One participant was randomized to Genotropin® but did not receive any treatment. This participant was excluded from FAS but included in Control for safety analysis.||SDS||Standard Error|Least Squares Mean
759805|NCT00627523|Primary|Change From Baseline in Height Standard Deviation Score (SDS) at Month 24.|Height SDS was calculated at the relevant visit by means of the following formula: Height SDS = (participant height) - (normal height)/normal height standard deviation. Where participant height refers to the participant’s height at the relevant visit, and normal height and the normal height standard deviation equals the population mean and standard deviation values for participants of a similar age and gender. The change from Baseline value for height SDS was calculated as the difference between the parameter values at a specific visit, and the Baseline parameter values. The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender.|Baseline and Month 24|Full Analysis Set (FAS) included participants who were randomized to treatment and completed at least one post-baseline efficacy measure. Missing values were imputed using LOCF method. One participant was randomized to Genotropin® but did not receive any treatment. This participant was excluded from FAS but included in Control for safety analysis.||SDS||Standard Error|Least Squares Mean
759806|NCT00627679|Primary|Half-life (t1/2) of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010|Half-life (t1/2) is the time for the drug to decrease to half of its maximum concentration. Budesonide t1/2 is reported in minutes (min).|8 hours|||min||Standard Deviation|Mean
765394|NCT00677235|Secondary|Demonstrate Non-inferiority of FLAIR Safety in Terms of Serious Adverse Events at 12 Months|Serious Adverse Events at 12 months are reported for all 270 subjects.|12 months|||percentage of participants with serious|||Number
759808|NCT00627679|Primary|AUC(0-8) of Budesonide After Administration of Pulmicort Respules® and Three Doses of MAP0010|The AUC(0-8) is the area under the plot of plasma concentration of drug against time after drug administration. Budesonide AUC(0-8) is reported in picograms times minutes per milliliter (pg*min/ml).|8 hours|Patients with available data at specified time points are included in the analysis population.||pg*min/mL||Standard Deviation|Mean
759809|NCT00627679|Primary|Tmax of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010|Tmax is the time to maximum concentration of a drug in the plasma. The Tmax of budesonide is reported in minutes (min).|8 hours|Patients with available data at specified time points are included in the analysis population.||min||Standard Deviation|Mean
759810|NCT00627679|Primary|Cmax of of Budesonide After Administration of Pulmicort and Three Dose Levels of MAP0010|The maximum concentration (Cmax) is the highest concentration of a drug measured in the plasma. Plasma is the clear portion of the blood. The Cmax of Budesonide is reported in picograms per milliliter (pg/ml).|8 hours|Patients with available data at specified time points are included in the analysis population.||pg/mL||Standard Deviation|Mean
759811|NCT00627705|Secondary|Glutathione (GSH) Metabolism Intermediates in Peripheral Blood||12 weeks|Data not collected. The measure was not analyzed. The lab was not able to measure Glutathione for the study.|||||
759812|NCT00627705|Secondary|Sensory Profile Questionnaire (SPQ)||12 weeks|Data not collected. Measure not analyzed.|||||
759813|NCT00627705|Secondary|Social Responsiveness Scale (SRS)|SRS total score (range 0-195); higher scores mean more social impairment|12 weeks|We analyzed subjects who had follow-up data available.||SRS total score (range 0-195)||Standard Deviation|Mean
759814|NCT00627705|Secondary|The Aberrant Behavior Checklist Total Score (ABC)|Total score was not analyzed since we analyzed the sub scales. Additionally, the authors of the instrument do not recommend analyzing the total score.|4, 8, and 12 weeks|Measure not analyzed.|||||
759815|NCT00627705|Primary|Irritability Subscale of the Aberrant Behavior Checklist (ABC)|Aberrant Behavior Checklist (ABC) Irritability Subscale Score (range 0-45); higher scores mean higher irritability|baseline and 12 weeks|We analyzed subjects who had follow-up data available.||Score (range 0-45)||Standard Deviation|Mean
759816|NCT00627705|Primary|Glutathione (GSH) Levels in Peripheral Blood, Measured by State-of-the-art High-performance Liquid Chromatography (HPLC)|Data not collected. The laboratory was not able to measure Glutathione levels.|12 weeks|Data not collected.|||||
759817|NCT00627705|Primary|The Clinical Global Rating Scale (CGRS) Improvement Subscale Score|Score range 1-7 (lower score mean more improvement compared to baseline)|12 weeks|We analyzed subjects who had follow-up data available.||score (range 1-7)||Standard Deviation|Mean
759818|NCT00627705|Primary|Total Number of Subjects With Reported Side Effects as Assessed by Dosage Record and Treatment Emergent Symptom Scale (DOTES)|The Dosage Record and Treatment Emergent Symptom Scale (DOTES) provides information on the presence, frequency, and severity of side effects reported during the course of the trial.|4, 8, and 12 weeks|We analyzed subjects who had follow-up data available.||participants|||Number
759819|NCT00627861|Secondary|Blood Pressure||all visits (weekly for 12 weeks)|||mm Hg|||Number
759820|NCT00627861|Secondary|Plasma Renin Activity|The blood test, plasma renin activity or PRA, is being measured during the visits outlined.|screening, 4th, 6th, 7th, 9th, 10th, 11th, 12th weeks|||ng/mL/h|||Number
759821|NCT00627861|Primary|Plasma Renin Concentration||5th, 6th, 7th, 9th, 10th, 11th, 12th weeks|||pg/mL|||Number
759822|NCT00627926|Secondary|Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)|"AE: any adverse change from the subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Study drug includes all investigational agents (including placebo, if applicable) administered during the course of the study."|Baseline up to Week 48|The FA set included all randomized subjects who received at least 1 dose of any study drug.||participants|||Number
759823|NCT00627926|Primary|Number of Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels 24 Weeks After Last Planned Dose of Study Treatment|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. Two results are reported: 1) Protocol defined SVR: undetectable HCV RNA at 24 weeks after the last planned dose of study treatment without any confirmed detectable HCV RNA between end of treatment visit (up to Week 48) and 24 weeks after last planned dose (up to Week 72); 2) SVR as per FDA guidance (snapshot analysis): undetectable HCV RNA at 24 weeks after the last planned dose of study treatment. Analysis was based only on the HCV RNA assessment in visit window (+/-2 weeks); if there were more than 1 assessment in the window, the last measurement was used.|24 weeks after last planned dose of study treatment (up to Week 72)|The full analysis (FA) set included all randomized subjects who received at least 1 dose of any study drug.||participants|||Number
759824|NCT00627926|Secondary|Fatigue Severity Scale (FSS) Total Score|FSS was a 9-item questionnaire where each item was scored on a scale of 1 to 7 (higher scores indicated higher influence of fatigue). FSS total score was calculated as the average of individual items on the questionnaire and FSS total score ranged from 1 to 7, where higher score indicated higher influence of fatigue.|Baseline, Week 4, 12, 24, 36, 48, 72|"The FA set included all randomized subjects who received at least 1 dose of any study drug. Here n signifies those participants who were evaluable for this measure at given time points for each group, respectively."||units on a scale||Standard Deviation|Mean
759837|NCT00628030|Secondary|Parental BMI|Height and weight were measured by trained staff and used to calculate BMI. Change scores of parental BMI from baseline to posttest were calculated to show difference between treatment arms.|Baseline, Posttest|||kg/m^2||Standard Deviation|Mean
759877|NCT00628407|Primary|Sternal Force Associated With Change in Intrathoracic Pressure.|The mean sternal force (measured in kg as a surrogate for Newtons [1kg = 9.81 newtons]) associated with a ≥2cm H2O peak endotracheal pressure (ETP) change.|per case|||kg||Standard Deviation|Mean
759825|NCT00627926|Secondary|Noninvasive Markers of Fibrosis: Number of Subjects With Improvement in FibroTest Analysis|FibroTest analysis was a biomarker analysis test used to generate a score that was correlated with the degree of liver damage. The FibroTest score was calculated from the results of a six-parameter blood test, combining six serum markers (alpha-2-macroglobulin, haptoglobin, apolipoprotein A1, gamma-glutamyl transpeptidase, total bilirubin, and alanine transaminase). The FibroTest score (F score) may range from 0.00 (Grade F0) to 1.00 (Grade F4), where F0= no fibrosis and F4=cirrhosis. Results were presented separately for subjects who achieved SVR at 24 weeks after the last planned dose of study treatment and those who did not achieve SVR at 24 weeks after the last planned dose of study treatment. Improvement was defined as decrease of at least 1 grade relative to baseline.|Baseline through 24 weeks after last planned dose of study treatment (up to Week 72)|"The FA set included all randomized subjects who received at least 1 dose of any study drug. Here number of participants analyzed signifies those subjects who were evaluable for FibroTest Analysis and n signifies those subjects who were evaluable for FibroTest Analysis in specified category for each treatment arm, respectively."||participants|||Number
759826|NCT00627926|Secondary|Biochemical Response: Number of Subjects With Grade 3 and 4 Shifts From Baseline in Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) Levels|Criteria for grading severity (toxicity) of ALT and AST: Grade 0 (<1.25*upper limit of normal [ULN]); Grade 1 (mild=1.25 to 2.5*ULN); Grade 2 (moderate=2.6 to 5.0*ULN); Grade 3 (severe= greater than 5.0 to 20.0*ULN); Grade 4 (life-threatening= greater than 20.0*ULN). Number of subjects with Grade 3 shift (from Grade 0, Grade 1 or Grade 2 baseline) and Grade 4 shift (from Grade 0, Grade 1, Grade 2 or Grade 3 baseline) are reported. If a subject experienced more than 1 severity grade shifts during post baseline assessments, the maximum severity grade shift was considered.|Baseline up to Week 48|The FA set included all randomized subjects who received at least 1 dose of any study drug.||participants|||Number
759827|NCT00627926|Secondary|Number of Subjects With Viral Relapse Planned and Viral Relapse Actual|Viral relapse was defined as having detectable HCV RNA during antiviral follow-up. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. For viral relapse, 2 analyses were performed: planned and actual. The planned analyses was measured from the end of treatment (EOT) visit to 24 weeks after the last planned dose of study treatment. The actual analyses was measured from the EOT visit to 24 weeks after the last actual dose of study treatment.|After last dose of study drug up to 24 week antiviral follow-up (up to Week 72)|Analysis population included subjects who completed their assigned study drug treatment and had undetectable HCV RNA at the completion of treatment (up to Week 48).||participants|||Number
759828|NCT00627926|Secondary|Number of Subjects With Undetectable HCV RNA 24 Weeks After Last Actual Dose of Study Treatment|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL.|24 weeks after last actual dose of study treatment (up to Week 72)|The FA set included all randomized subjects who received at least 1 dose of any study drug.||participants|||Number
759829|NCT00627926|Secondary|Number of Subjects With Undetectable HCV RNA 12 Weeks After Last Planned Dose of Study Treatment|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL.|12 weeks after last planned dose of study treatment (up to Week 60)|The FA set included all randomized subjects who received at least 1 dose of any study drug.||participants|||Number
759830|NCT00627926|Secondary|Number of Subjects With Undetectable HCV RNA at End of Treatment (EOT)|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL.|End of treatment (up to Week 48)|The FA set included all randomized subjects who received at least 1 dose of any study drug.||participants|||Number
759831|NCT00627926|Secondary|Number of Subjects With Undetectable HCV RNA at Week 12|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL.|Week 12|The FA set included all randomized subjects who received at least 1 dose of any study drug.||participants|||Number
759832|NCT00627926|Secondary|Number of Subjects Achieving Extended Rapid Viral Response (eRVR), Demonstrated by Achieving Undetectable HCV RNA at Week 4 and at Week 12|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. eRVR was defined as undetectable HCV RNA at both Week 4 and Week 12.|Week 4 and Week 12|The FA set included all randomized subjects who received at least 1 dose of any study drug.||participants|||Number
759833|NCT00627926|Secondary|Number of Subjects Achieving Rapid Viral Response (RVR), Demonstrated by Achieving Undetectable HCV RNA 4 Weeks After Starting Study Treatment|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. RVR was defined as undetectable HCV RNA 4 weeks after the start of study treatment.|Week 4|The FA set included all randomized subjects who received at least 1 dose of any study drug.||participants|||Number
759834|NCT00627926|Secondary|Number of Subjects With Undetectable HCV RNA at Week 72|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL.|Week 72 (24 weeks after last dose for subjects with a planned treatment duration of 48 weeks and 48 weeks after last dose for subjects with planned treatment duration of 24 weeks)|The FA set included all randomized subjects who received at least 1 dose of any study drug.||participants|||Number
759835|NCT00627978|Primary|Axons With Abnormal Morphology|Digital photographs for morphometry were captured at a magnification of 8000–16,000x and the photos were uploaded onto an imaging platform of transmission electron microscope (iTEM) (Olympus, Mu¨nster, Germany). The figures were enlarged by 50%, and an individual linear array was used to measure the axonal diameter (cross-sectional area) and the number of unmyelinated axons per Remak Schwann cell was enumerated according to the established methodology.|Baseline and Over 7 cycles of treatment, approximately 21 weeks|||percentage of axons|||Number
759836|NCT00628030|Secondary|Parental Dietary Intake of Fat|Parents completed a 3 day dietary record which was reviewed by a dietitian and analyzed using the Nutrition Data System Software (NDS-R) to calculate parental fat intake. Change scores were calculated by subtracting post-test values from baseline values; thus, a negative score indicates a greater reduction in fat intake at post-testing.|Baseline, Posttest|||grams||Standard Deviation|Mean
759838|NCT00628030|Secondary|Child Quality of Life|"Pediatric Health-Related Quality of Life (PedsQL4.0) change scores from baseline to posttest
We reported the Total Score. The PedsQL4.0 response scale ranges from 0 - 4. The items are reverse-scored for interpretability and higher scores indicate higher quality of life.
We used the Total Score, or the mean computed as the sum of all the items over the number of items answered on all the Scales.
The current report did not provide subscores."|Basline, Posttest|||units on a scale||Standard Deviation|Mean
759839|NCT00628030|Secondary|Child Feeding|"The Child Feeding Questionnaire (CFQ) measured parental approaches to and attitudes about feeding their children and the subscale concern about child's weight is reported below in the table. The subscale score was calculated by averaging the items (subscale score range: 3 to 15, higher scores represent greater risk). To compare groups, change scores were calculated by subtracting post-test values from baseline values (negative scores indicate decline in parental concern from baseline to post-test)."|Basline, Posttest|||units on a scale||Standard Deviation|Mean
759840|NCT00628030|Primary|Child BMI|Children's height and weight were measured and then plotted on the CDC Growth Charts to obtain BMI%ile for age and gender.|Basline, Posttest|||percentile||Standard Deviation|Mean
759841|NCT00628108|Secondary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Creatinine||Baseline, 14 days|Safety Population; only non-missing values were analyzed||micromole per liter [μmol/L]||Full Range|Median
759842|NCT00628108|Secondary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Urea Nitrogen||Baseline, 14 days|Safety Population; only non-missing values were analyzed||millimole per liter [mmol/L]||Full Range|Median
759843|NCT00628108|Secondary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Aspartate Aminontransferase (AST)||Baseline, 14 days|Safety Population; only non-missing values were analyzed||unit per liter [U/L]||Full Range|Median
759844|NCT00628108|Secondary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Alanine Aminotransferase (ALT)||Baseline, 14 days|Safety Population; only non-missing values were analyzed||unit per liter [U/L]||Full Range|Median
759845|NCT00628108|Secondary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Total Bilirubin||Baseline, 14 days|Safety Population; only non-missing values were analyzed||micromole per liter [µmol/L]||Full Range|Median
759846|NCT00628108|Primary|Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia’s Formula (QTcF) at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV)|The QT interval refers to the respective time interval in the Electrocardiogram (ECG)|14 days|Safety Population; only non-missing values were analyzed||milliseconds||Standard Deviation|Mean
759847|NCT00628108|Primary|Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia’s Formula (QTcF) at Visit 3 (Day 7)|The QT interval refers to the respective time interval in the Electrocardiogram (ECG)|7 days|Safety Population; only non-missing values were analyzed||milliseconds||Standard Deviation|Mean
759848|NCT00628108|Primary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval Corrected for Heart Rate Using Fridericia’s Formula (QTcF)|The QT interval refers to the respective time interval in the Electrocardiogram (ECG)|Baseline, 14 days|Safety Population; only non-missing values were analyzed||milliseconds||Standard Deviation|Mean
759849|NCT00628108|Primary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval|The QT interval refers to the respective time in the Electrocardiogram (ECG)|Baseline, 14 days|Safety Population; only non-missing values were analyzed||milliseconds||Standard Deviation|Mean
759850|NCT00628108|Primary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QRS Duration|The QRS duration refers to the respective time interval in the Electrocardiogram (ECG)|Baseline, 14 days|Safety Population; only non-missing values were analyzed||milliseconds||Standard Deviation|Mean
759851|NCT00628108|Primary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in PR Interval|The PR interval refers to the respective time interval in the Electrocardiogram (ECG)|Baseline, 14 days|Safety Population; only non-missing values were analyzed||milliseconds||Standard Deviation|Mean
759852|NCT00628108|Primary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in RR Interval|The RR interval refers to the respective time interval in the Electrocardiogram (ECG)|Baseline, 14 days|Safety Population; only non-missing values were analyzed||milliseconds||Standard Deviation|Mean
759853|NCT00628108|Primary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Ventricular Rate (VR)||Baseline, 14 days|Safety Population; only non-missing values were analyzed||beats per minute||Standard Deviation|Mean
759854|NCT00628134|Secondary|Peripheral Lung Dose|Change over 30 minutes in the percentage of the total deposited aerosol dose found in the peripheral lung zone. We are reporting the %peripheral dose at t=30 minus the %peripheral dose at t=0. This dose is determined based on measured radioactive counts after aerosol delivery, using nuclear medicine gamma camera images. The central lung zone is defined as a rectangle with 1/2 the height and 1/2 the width of a rectangle that surrounds the right whole lung. The peripheral zone is the portion of the lung image not included in the central lung zone.|30 minutes after delivery|||percentage of lung dose||Standard Deviation|Mean
759855|NCT00628134|Primary|Uniformity of Aerosol Distribution|Measured change in central/peripheral (c/p) dose ratio over a 30 minute period after aersol delivery (c/p at t=30 - c/p at t=0). Central and peripheral lung doses are measured as radioactive counts depicted on nuclear medicine gamma camera images after radioisotope aerosol delivery. The central lung zone is a rectangle with 1/2 the height and 1/2 the width of a box outlining the whole right lung. The peripheral lung zone is defined as the portion of the lung outside of the central lung zone. A change in c/p ratio over time would indicate transport of material from one lung zone to the other. The variable represents the realtive proportion of airways dosing to alveolar dosing - an indication of deposition uniformity in the lungs.|30 minutes|||ratio||Standard Deviation|Mean
759856|NCT00628147|Secondary|Procedure Complications||procedure and post-procedure complications within 30 days after colonoscopy|||Participants|||Count of Participants
759857|NCT00628147|Secondary|Completion of Examinations||same day|||Participants|||Count of Participants
759858|NCT00628147|Secondary|Neoplasm Detection Rates||same day|We report overall neoplasia detection rate, and then report a sub-analysis for the neoplasia detection rates by indication (screening vs non-screening).||Participants|||Count of Participants
759859|NCT00628147|Primary|Neoplasm Miss Rate||same day|||Miss rate percentage||95% Confidence Interval|Number
759860|NCT00628212|Secondary|Change From Baseline in the Areas Under the Curve From 0 to 2 h (AUC0–2h) for Postprandial Plasma Glucose at Week 12|The change from Baseline in AUC0–2h for Postprandial Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline AUC0–2h for Postprandial Plasma Glucose as a covariate.|12 weeks|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization.||mg*h / dL||Standard Error|Least Squares Mean
759861|NCT00628212|Secondary|Change From Baseline in 2-hour Postprandial Plasma Glucose at Week 12|The change from Baseline in 2-hour Postprandial Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline 2-hour Postprandial Plasma Glucose as a covariate.|12 weeks|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization.||mg / dL||Standard Error|Least Squares Mean
759862|NCT00628212|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 12|The change from Baseline in Fasting Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline Fasting Plasma Glucose as a covariate.|12 weeks|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization. Analysis based on last observation carried forward, where the last postbaseline double-blind observed value was carried forward and used for Week 12 where data was missing.||mg / dL||Standard Error|Least Squares Mean
759863|NCT00628212|Primary|Change From Baseline in HbA1c at Week 12|The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate.|12 weeks|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization. Analysis based on last observation carried forward, where the last postbaseline double-blind observed value was carried forward and used for Week 12 where data was missing.||Percent||Standard Error|Least Squares Mean
759864|NCT00628251|Secondary|Best QoL Response for FACT-O Symptom Index (FOSI)|Best HRQoL response using the FOSI endpoint. Improvement was defined as a change from baseline of greater than or equal to +3.|At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)|Evaluable for FOSI at baseline||Number of patients|||Number
759865|NCT00628251|Secondary|Best QoL Response for Total Functional Analysis of Cancer Therapy - Ovarian (FACT-O)|Best HRQoL response using the total FACT-O endpoint. Improvement was defined as a change from baseline of greater than or equal to +9.|At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)|Evaluable for FACT-O at baseline||Number of patients|||Number
759866|NCT00628251|Secondary|Best Quality of Life (QoL) Response for Trial Outcome Index (TOI)|Best HRQoL response using the TOI endpoint. Improvement was defined as a change from baseline of greater than or equal to +7. The TOI score ranges from 0-100.|At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)|Evaluable for TOI at baseline||Number of patients|||Number
759867|NCT00628251|Secondary|Overall Survival (OS)|OS was defined as time from randomisation to date of death from any cause. Patients who had not died at time of analysis were censored at last date they were known to be alive. Median OS was not calculable for olaparib groups due to an insufficient number of deaths so the percentage of participants who died are shown along with 95% confidence intervals|At the time of the cut-off for the final analysis of overall survival (30 April 2010)|||Number of deaths|||Number
759868|NCT00628251|Secondary|Disease Control Rate|The number of patients with confirmed CR (disappearance of all target lesions) or PR (30% decrease in the sum of the longest diameter of target lesions ) or SD ( small changes ) >4 months, divided by the number of randomised patients|At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)|||Participants|||Number
759869|NCT00628251|Secondary|Confirmed RECIST Response and/or CA-125 Response|The percentage of patients reporting a RECIST confirmed response and/or a CA-125 response (in the absence of progression). A CA-125 response was defined as a confirmed greater or equal to 50% reduction in CA-125.|At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)|||Percentage of participants|||Number
759870|NCT00628251|Secondary|Best Percentage Change From Baseline in CA-125 Levels|Best percentage change in cancer antigen 125 (CA-125) levels|At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)|||Percent change||Full Range|Median
759871|NCT00628251|Secondary|Best Percentage Change in Tumour Size|The percentage change (reduction) from baseline in the sum of the lengths of the longest diameter (LD) of the RECIST target lesions were objectively documented, regardless of whether the patient was still taking study medication|At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)|||Percent change||Full Range|Median
759872|NCT00628251|Secondary|Duration of Response|The duration of response was defined as time (months) from initial assessment of PR/CR until earliest date of objective progression or death. (Values may be underestimated as some patients had not progressed at final analysis so true duration is likely to be greater than that in database.)|At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)|Duration of response is analysed for patients experiencing a response.||Months||95% Confidence Interval|Median
759873|NCT00628251|Secondary|Objective Response Rate (ORR) (According to Response Evaluation Criteria in Solid Tumours - RECIST)|ORR was defined according to RECIST. Complete response (CR) or partial response - (PR)- 30% decrease Patients with a best RECIST response of CR or PR had to have a confirmed response at least 28 days later.|At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)|||Number of responders|||Number
759874|NCT00628251|Primary|Progression Free Survival (PFS) (According to Response Evaluation Criteria in Solid Tumours [RECIST])|PFS was defined as the time to progression from the date of randomisation until the date of radiological assessment of progression per RECIST criteria or death (by any cause in the absence of progression)|Tumour assessment was to be assessed at screening, every 8 weeks during the study and at the withdrawal visit, up to 56 weeks. (Data cut-off for primary analysis of PFS: 15 September 2009)|||Number of patients that progressed|||Number
759878|NCT00628446|Secondary|Adherence to NCEP Criteria|Determine the total percentage of subjects who should be on drug therapy by NCEP criteria and who are on drug therapy who have achieved their treatment goal as defined by NCEP criteria|During single data collection|38 subjects completed the data collection||percentage of participants|||Number
759879|NCT00628446|Primary|Percent Agreement Between Coronary Calcium Score (CCS) and National Cholesterol Education Program (NCEP) Guidelines|Participants were classified as high risk, intermediate high risk, intermediate low risk, and low risk based upon both their CCS and their LDL using NCEP Adult Treatment Panel III Guidelines. Those with CCS >/-400 were considered high risk, CCS=100-399 were intermediate high risk, CCS=1-99 intermediate low risk, and CCS=0 were low risk. The percent agreement between CCS and NCEP Guidelines was calculated by totaling the number of subjects who were classified in the same risk category and dividing by the total number of subjects|During single data collection. Average duration of injury was 24.4 years +/-9.5 years|||percent agreement|||Number
759880|NCT00628589|Secondary|CGI-I Responders|Frequency of response based on the CGI-I (defined as achieving a CGI-I score of 1 or 2 at 2 hours after administration of the inhalation)|Baseline and 2 hours|ITT Population with LOCF||Participants|||Count of Participants
759881|NCT00628589|Secondary|Clinical Global Impression-Improvement (CGI-I) Score|Clinical Global Impression- Improvement (CGI-I) scores ranged from 1 to 7: 0=not assessed (missing), 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse.|Baseline and 2 hours|ITT Population with LOCF||units on a scale||Standard Deviation|Mean
759882|NCT00628589|Primary|Change in PANSS-EC From Baseline|The Positive and Negative Syndrome Scale–Excited Component (PANSS–EC) comprises 5 items associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored 1 (min) to 7 (max). The PANSS-EC, the sum of these 5 subscales, thus ranges from 5 to 35. Individuals were eligible if they had a PANSS-EC of ≥14 (out of 35) and a score ≥4 (out of 7) on at least 1 of the 5 items.|Baseline and 2 hours|ITT Population with LOCF||units on a scale||Standard Deviation|Mean
759883|NCT00628628|Primary|Number of Participants With Plasma Uric Acid (UA) Response|Plasma UA response is defined as normalization of plasma UA levels within 48 hours after the start of study drug (rasburicase) and maintaining within the normal range after the final drug infusion on day 5. Plasma samples for UA were collected at baseline before rasburicase, 4- and 24-hours post-rasburicase, and daily during treatment.|First cycle of chemotherapy, up to 5 days|||participants|||Number
759884|NCT00628758|Secondary|Mean Use of As-needed Medication Per Day During Treatment Period|Mean use of as-needed medication per day during treatment period|Daily recording during the treatment period of 26 weeks|ITT analysis was performed. Being in line with the analysis description population and due to description of the variable which was based on the patient’s estimate, this variable could only be calculated of the patients who had recorded at least one estimate on their dairies they had been asked to return to the investigator at the study visits.||inhalations per day||Standard Deviation|Mean
759885|NCT00628758|Secondary|Change in Standardised Asthma Quality of Life Questionnaire (AQLQ(S)) Score|Quality-of-Life assessment; grouped in four domains;activity limitation, symptoms, emotional function and exposure to environmental stimuli, using with a scale from 1 to 7 where 1 represents the greatest possible impairment and 7 represents the least impairment.|Baseline and 26 weeks|ITT analysis was performed. Being in line with the analysis description population and due to the description of the variable. This patient-reported outcome variable could only be calculated for patients who have baseline and visit 4 AQLQ data. The AQLQ was not filled in by all enrolled patients.||Units on a scale||Standard Deviation|Mean
759886|NCT00628758|Secondary|Number of Severe Asthma Exacerbations|Total number of severe asthma exacerbations per treatment group|26 weeks|||Severe Exacerbations|||Number
759887|NCT00628758|Primary|Time to First Severe Asthma Exacerbation|Time to severe exacerbation among patients|26 weeks|||days||Standard Deviation|Mean
759888|NCT00628862|Secondary|St George’s Respiratory Questionnaire (SGRQ)|Patients were asked to complete the St George’s Respiratory Questionnaire (SGRQ). Subscale symptom score ranges from 0 to 100% and measures the effect of respiratory symptoms, frequency, and severity on quality of life. A score of 0 indicates the best possible status. Results are expressed as the change from baseline score with a decrease in score indicating improvement.|12 weeks (end of run-in to last visit)|||Scores on a scale||Standard Deviation|Mean
759889|NCT00628862|Secondary|Use of Reliever Medication|Patients were asked to record reliever medication use. Period averages over the last 10 days of the run-in period and the whole treatment period were calculated. The results are expressed as the change from the run-in period average value|12 weeks (end of run-in to last visit)|||medication doses per day||Standard Deviation|Mean
759890|NCT00628862|Secondary|Cough|Patients were asked to record cough (scored from 0-4 with 4 being the most severe). Period averages over the last 10 days of the run-in period and the whole treatment period were calculated. The results are expressed as the change from the run-in period average value|run-in period up to 12 weeks|||scores on a scale per day||Standard Deviation|Mean
759891|NCT00628862|Secondary|Breathlessness|Patients were asked to record breathlessness (scored from 0-4 with 4 being the most severe). Period averages over the last 10 days of the run-in period and the whole treatment period were calculated. The results are expressed as the change from the run-in period average value|run-in period up to 12 weeks|||scores on a scale per day||Standard Deviation|Mean
759892|NCT00628862|Secondary|Change in Night-time Awakenings Due to Symptoms|Patients were asked to record the night-time awakenings due to symptoms (scored from 0-4 with 4 being the most severe). Period averages over the last 10 days of the run-in period and the whole treatment period were calculated. The results are expressed as the change from the run-in period average value|run-in period up to 12 weeks|||scores on a scale per day||Standard Deviation|Mean
759893|NCT00628862|Secondary|Change in Peak Expiratory Flow (PEF), Evening|Patients were asked to measure and record lung function (peak expiratory flow [PEF] measured in the evening). Average values over the last 10 days of the run-in period and the whole treatment period were calculated. The results are expressed as the change from the run-in period average value|run-in period and 12 week|||L/min||Standard Deviation|Mean
759894|NCT00628862|Secondary|Change in Peak Expiratory Flow (PEF), Morning|Patients were asked to measure and record lung function (peak expiratory flow [PEF] measured in the morning). Average values over the last 10 days of the run-in period and the whole treatment period were calculated. The results are expressed as the change from the run-in period average value|run-in period and 12 week|||L/min||Standard Deviation|Mean
759895|NCT00628862|Secondary|FVC 5 Minutes Post-dose|Lung function (FVC) was measured 5 minutes after the first dose of study drug, The results are expressed as a percentage in relation to the baseline value|baseline and 5 minutes anter first dose|||percent of baseline||Full Range|Geometric Mean
759896|NCT00628862|Secondary|FEV1 5 Minutes Post-dose|Lung function (FEV1) was measured 5 minutes after the first dose of study drug. The results are expressed as a percentage in relation to the baseline value|baseline and 5 minutes anter first dose|||percent of baseline||Full Range|Geometric Mean
759897|NCT00628862|Secondary|FVC Pre-dose|Lung function (FVC) was measured before administrations of the study drug (pre-dose). The results are expressed as a percentage of mean FEV1 over visists 4-6 in relation to the baseline (visit 3) value|baseline at week 0 and pre-dose at weeks 4, 8 and 12|||percent of baseline||Full Range|Geometric Mean
759898|NCT00628862|Secondary|FEV1 Pre-dose|Lung function (FEV1) was measured before administrations of the study drug (pre-dose). The results are expressed as a percentage of mean FEV1 over visists 4-6 in relation to the baseline (visit 3) value|baseline at week 0 and pre-dose at weeks 4, 8 and 12|||percent of baseline||Full Range|Geometric Mean
759899|NCT00628862|Secondary|Forced Vital Capacity (FVC) 60 Minutes Post-dose|Forced Vital Capacity (FVC) is a spirometric measure of lung function. FVC was measured 60 minutes after administration of study drug. The results are expressed as a percentage in relation to the baseline value|from baseline up to 12 weeks|||percent of baseline||Full Range|Geometric Mean
759900|NCT00628862|Primary|Forced Expiratory Volume in 1 Second (FEV1; L) 60 Minutes Post-dose|FEV1 (expressed as litres [L]) is a spirometric measure of lung function. FEV1 was measured 60 minutes after administration of study drug. The results are expressed as a percentage in relation to the baseline value.|from baseline up to 12 weeks|||percent of baseline||Full Range|Geometric Mean
759901|NCT00628901|Secondary|Health Related Quality of Life Subscores|"The HRQL subscales (concern, activities, energy/mood, control, self-conscious, and sexual function were collected from the UFS-QoL.
Each individual subscale is added. HRQL Total (sum of 6 subscales); lowest possible raw score = 29, highest possible raw score=145. A formula is used to transform the HRQL raw scores (Highest possible score-actual raw score divided by possible raw score range x 100). Higher scores are indicative of a better HRQL and lower scores indicate a worse HRQL (High=good). The value reported for this measure is the average of all participants scores."|12 months|||Scores on a scale||Standard Deviation|Mean
759902|NCT00628901|Secondary|Health Related Quality of Life Subscores|"The HRQL subscales (concern, activities, energy/mood, control, self-conscious, and sexual function were collected from the UFS-QoL.
Each individual subscale is added. HRQL Total (sum of 6 subscales); lowest possible raw score = 29, highest possible raw score=145. A formula is used to transform the HRQL raw scores (Highest possible score-actual raw score divided by possible raw score range x 100). Higher scores are indicative of a better HRQL and lower scores indicate a worse HRQL (High=good). The value reported for this measure is the average of all participants scores."|3 months|||Scores||Standard Deviation|Mean
759903|NCT00628901|Secondary|Health Related Quality of Life (HRQL)Subscores|"The HRQL subscales (concern, activities, energy/mood, control, self-conscious, and sexual function were collected from the UFS-QoL.
Each individual subscale is added. HRQL Total (sum of 6 subscales); lowest possible raw score = 29, highest possible raw score=145. A formula is used to transform the HRQL raw scores (Highest possible score-actual raw score divided by possible raw score range x 100). Higher scores are indicative of a better HRQL and lower scores indicate a worse HRQL (High=good). The value reported for this measure is the average of all participants scores."|Baseline|||Scores on a scale||Standard Deviation|Mean
759904|NCT00628901|Secondary|Uterine Fibroid Symptom Quality of Life Questionaire (UFS-QOL) Score|"The UFS-QoL asks the subjects feelings and experiences regarding the impact of uterine fibroid symptoms and experiences during the previous 3 months.
The scores are added and the final total scores range from 0-100.The lowest actual raw score=8, the highest raw score=40, the possible raw score range=32. A formula is then used to transform the value(actual raw score-lowest possible raw score divided by possible raw score range x100). Higher symptom score values are indicative of greater symptom severity or bother and lower scores indicate minimal symptom severity (high scores = bad)."|12 months|||Scores on a scale||Standard Deviation|Mean
759905|NCT00628901|Secondary|Uterine Fibroid Symptom Quality of Life Questionaire (UFS-QOL) Score|"The UFS-QoL asks the subjects feelings and experiences regarding the impact of uterine fibroid symptoms and experiences during the previous 3 months.
The scores are added and the final total scores range from 0-100. The lowest actual raw score=8, the highest raw score=40, the possible raw score range=32. A formula is then used to transform the value(actual raw score-lowest possible raw score divided by possible raw score range x100). Higher symptom score values are indicative of greater symptom severity or bother and lower scores indicate minimal symptom severity (high scores = bad)"|3-months|||Scores on a scale||Standard Deviation|Mean
759906|NCT00628901|Secondary|Uterine Fibroid Symptom Quality of Life Questionaire (UFS-QOL) Score|"The UFS-QoL asks the subjects feelings and experiences regarding the impact of uterine fibroid symptoms and experiences during the previous 3 months.
The scores are added and the final total scores range from 0-100. The lowest actual raw score=8, the highest raw score=40, the possible raw score range=32. A formula is then used to transform the value(actual raw score-lowest possible raw score divided by possible raw score range x100). Higher symptom score values are indicative of greater symptom severity or bother and lower scores indicate minimal symptom severity (high scores = bad)"|Baseline|||Scores on a scale||Standard Deviation|Mean
759907|NCT00628901|Secondary|Any Adverse Events That the Participant Experienced|Summary of investigator reported adverse events and adverse device effects, including all serious adverse events and unanticipated adverse device effects. Adverse events were collected systematically, meaning they were collected during the participant's follow-up visit, during telephone contacts, or during medical record review.|During the hospitalization stay post UFE|||events|||Number
759908|NCT00628901|Secondary|Procedure Time|Procedure time is the time in minutes of the first arterial puncture to time of hemostasis (stopping bleeding)|During the study procedure (measured in minutes)|||minutes||Standard Deviation|Mean
759909|NCT00628901|Secondary|Fluoroscopy Time|Fluoroscopy is the method that provides real-time X ray imaging used for guiding a variety of diagnostic and interventional procedures. Fluoroscopy time is described as the amount of time the patient underwent fluoroscopy.|During the study procedure (measured in minutes)|||minutes||Standard Deviation|Mean
759935|NCT00629239|Primary|Number of Patients Experiencing Adverse Events|Number of patients who had an Adverse Event|At all study visits|||Participants|||Number
759910|NCT00628901|Secondary|Visual Analog Scale (VAS) Maximum Level of Pain|Maximum level of pain was measured using the Visual Analog Scale(VAS). The patient is presented with a picture of a straight line that is 0-10 cm long. The left side of the line (0 cm) represents 'no pain' and the right side (10cm) of the line represents 'worst imaginable'. The patient is asked to place a mark on the line that represents their level of pain. For example, a reading of 10cm = worst imaginable pain.|24 hours after study procedure|||cm||Standard Deviation|Mean
759911|NCT00628901|Secondary|Visual Analog Scale (VAS) Maximum Level of Nausea|Maximum level of nausea was measured using the Visual Analog Scale(VAS). The patient is presented with a picture of a straight line that is 0-10 cm long. The left side of the line (0 cm) represents 'no nausea' and the right side (10cm) of the line represents 'worst nausea imaginable'. The patient is asked to place a mark on the line that represents their level of nausea. For example, a reading of 10cm = worst nausea imaginable.|24 hours after study procedure|||cm||Standard Deviation|Mean
759912|NCT00628901|Primary|Number of Participants With Fibroid Devascularization Measured by Contrast Enhanced Magnetic Resonance Imaging (MRI)|MRI uses a large circular magnet and radio waves to generate signals from atoms in the body. These signals are used to construct images of internal structures. Injection of contrast through an IV is done during the test to enhance the view of the uterus. Contrast enhanced MRI was used as a test in this study to verify if blood supply to the fibroids was blocked or interrupted (devascularization).|24-hours post study procedure|||participants|||Number
759913|NCT00628927|Secondary|Tail Length From the Comet Assay for Oxidative Damage|The test for oxidative damage was derived from a blood sample which was analyzed for tail length from the comet assay; higher scores reflect greater oxidative damage.|Single study visit|||µm||Standard Deviation|Mean
759914|NCT00628927|Secondary|Barrett Impulsiveness Scale Version 11 (BIS-11)|"The BIS-11 consists of 30 self-report items, with responses in a four-point Likert-type scale (0 - 3)ranging from Rarely/Never to Almost Always/Always and comprises three domains: Attentional impulsiveness (AI), Motor impulsiveness (MI), and Non-planning impulsiveness (NP); these three domains are summed to yield a total score; higher scores reflect greater impulsivity. The total score was utilized as the BIS-11 predictor measure (possible score range 0 - 90)."|Single study visit|||units on a scale||Standard Deviation|Mean
759915|NCT00628927|Primary|Stroop Color-word Task|The primary objective of this study was to replicate the finding that performance on the Stroop color-word interference task is predictive of treatment completion in participants with cocaine use disorders (Streeter et al., 2007) and to extend this finding to participants with methamphetamine use disorders. In the Stroop, the participant is required to name the color of the ink in which a word is printed while inhibiting the overlearned response of reading the word (e.g., the word ‘‘red’’ might be printed in blue ink). The number of errors were subtracted from the time required (RT; Reaction Time) for each of the 3 trials, yielding three summary scores. The derived interference score is obtained by subtracting the RT for the first trial from the RT for the third trial.|Single study visit|||seconds||Standard Deviation|Mean
759916|NCT00629018|Secondary|Changes in Left Ventricular Function||5 years||||||
759917|NCT00629018|Secondary|Changes in Plasma Inflammatory Markers||6 months||||||
759918|NCT00629018|Secondary|Changes in Electrophysiologic Properties of Ventricular Myocardium||6 months||||||
759919|NCT00629018|Secondary|Changes in Exercise Capacity||5 years||||||
759920|NCT00629018|Primary|Changes in Left Ventricular Ejection Fraction|Left ventricular ejection fraction measured by echocardiography|5 years|||Percentage of ejection||Standard Deviation|Mean
759921|NCT00629018|Primary|Heart Failure Mortality||5 years|The minimal sample size for the study was calculated using a pre-specified power of 90% and P value of 0.05.||participants|||Number
759922|NCT00629239|Secondary|6-minute Walk Test|Change from baseline to end of treatment|Before treatment and after 4 weeks of treatment|||meter||Full Range|Mean
759923|NCT00629239|Secondary|Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Sleep Score|Change from average during run-in to average during treatmentScores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe).|Daily during run-in and treatment|||Scores on a scale||Full Range|Mean
759924|NCT00629239|Secondary|Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Cough Score|Change from average during run-in to average during treatment. Scores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe).|Daily during run-in and treatment|||Scores on a scale||Full Range|Mean
759925|NCT00629239|Secondary|Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Chest Tightness|Change from average during run-in to average during treatment. Scores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe).|Daily during run-in and treatment|||Score on a scale||Full Range|Mean
759926|NCT00629239|Secondary|Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Breathlessness|Change from average during run-in to average during treatment. Scores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe).|Daily during run-in and treatment|||Scores on a scale||Full Range|Mean
759927|NCT00629239|Secondary|The Clinical COPD ( Chronic Obstructive Pulmonary Disease) Questionnaire (CCQ) Total|Change from baseline to end of treatment in score , The total scores vary between 0 (never/not limited at all) to 6 (almost all the time/totally limited)|Before treatment and after 1, 2, 3 and 4 weeks of treatment|||Score on a scale||Full Range|Mean
759928|NCT00629239|Secondary|Peak Expiratory Flow (PEF) Evening|Change in PEF from average during run-in to average during treatment|Daily during run-in and treatment|||L/min||Full Range|Mean
759929|NCT00629239|Secondary|Peak Expiratory Flow (PEF) Morning|Change from average during run-in to average during treatment|Daily during run-in and treatment|||L/min||Full Range|Mean
759930|NCT00629239|Secondary|Forced Expiratory Flow (FEF) 25%-75%|Change in FEF from baseline to end of treatment|Before treatment and after 1, 2, 3 and 4 weeks of treatment|||L/s||Full Range|Mean
759931|NCT00629239|Secondary|Inspiratory Capacity (IC)|Change from IC baseline to end of treatment|Before treatment and after 1, 2, 3 and 4 weeks of treatment|||L||Full Range|Mean
759932|NCT00629239|Secondary|Vital Capacity (VC)|Change in VC from baseline to end of treatment|Before treatment and after 1, 2, 3 and 4 weeks of treatment|||L||Full Range|Mean
759933|NCT00629239|Secondary|Forced Vital Capacity (FVC)|Change in FVC from baseline to end of treatment|Before treatment and after 1, 2, 3 and 4 weeks of treatment|||L||Full Range|Mean
759934|NCT00629239|Secondary|Forced Expiratory Volume 1 (FEV1)|Change in (FEV1) from baseline to end of treatment|Before treatment and after 1, 2, 3 and 4 weeks of treatment|||L||Full Range|Mean
759936|NCT00629265|Secondary|Performance Status Scale for Head and Neck Cancer Patients (PSS); The Head and Neck Cancer Inventory (HNCI)|"Perceive improved in quality of life and eating ability as measured by 2 validated scales: the Performance Status Scale for Head and Neck Cancer Patients (PSS) and The Head and Neck Cancer Inventory (HNCI).
The PSS (List, et. al., 1990) is a clinician adminsitered scale that has three domains (normalcy of diet, eating in public, and understandability of speech). Each domain as well as overall score is scored on a scale of 0-100, with 0=worst and 100=best.
The HNCI (Funk, et. al., 2003) is patient administered questionnaire that has four domains (social disruption, aesthetics, speech, eating). Each domain as well as overall score is scored on a scale of 0-100, with 0=worst and 100=best."|Before and after treatment|Note: the number of participants analyzed (126) does not match the total number enrolled (170) because 44 people did not have adequate follow up data required for this secondary analysis.||Change in PSS and HNCI score||Standard Deviation|Mean
759937|NCT00629265|Primary|Change in Penetration-Aspiration Scale (PAS) Score|"The PAS scale is a validated 8-point ordinal scale (Rosenbek et. al 1996) in which a score of 1 is best (material does not enter the airway) and a score of 8 is worst (material enters the airway, passes below the vocal folds, and no effort is made to eject it).
Difference in mean PAS scores after 12 weeks of therapy was analyzed between the two groups of interest: Active NMES + Swallowing Exercise versus Sham (inactive) NMES + Swallowing Exercise. PAS scores were obtained from fluoroscopy (modified barium swallow) studies adminstered at three time points - enrollment, midway through treatment (6 weeks), and at end of treatment (12 weeks). All fluoroscopy studies were sent to, and analyzed by, a blinded external central laboratory."|Before and after treatment|Note: the number of participants analyzed (125) does not match the total number enrolled (170) because 45 people did not have adequate follow up data required for this primary analysis.||Change in points on PAS||Standard Deviation|Mean
759938|NCT00629499|Secondary|Overall Survival||18 Months||||||
759939|NCT00629499|Secondary|Disease-free Survival||18 Months||||||
759940|NCT00629499|Primary|Tolerability of Adjuvant Nab Paclitaxel Using Weekly Dosing Schedule Assessed by Patient Survival, Disease Recurrence, and Treatment-related Toxicity.||18 Months|Patients were analyzed if they remained alive and without evidence of recurrence.||participants|||Number
759941|NCT00629525|Secondary|Clinical Response|"The percentage of participants with a complete or partial response as defined by RECIST 1.0. Response Criteria are defined below:
Complete Response: Disappearance of all target lesions Partial Response: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Progressive Disease: At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease: Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD"|Patients were followed for a median of 315 days|||participants|||Number
759942|NCT00629525|Secondary|Molecular Response|Functional extent of mTOR inhibition by changes in the phosphorylation status of pS6 in prostate tumors.|Patients were followed for a median of 315 days|Immunohistochemistry (IHC) for pS6 was compared for 9 pairs of samples for which paraffin embedded tissue was available.||percentage of decrease||Full Range|Mean
759943|NCT00629525|Secondary|Progression Free Survival|Time in months from the start of study treatment to the date of first progression according to RECIST 1.0, or to death due to any cause. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve.|Patients were followed for a median of 315 days, with the last patient censored at 1309 days.|Intent to treat||months||95% Confidence Interval|Median
759944|NCT00629525|Secondary|Pathologic Response|Number of participants with either a 50% or greater decrease in proliferation index or a 50% or greater increase in apoptotic index|Patients were followed for a median of 315 days|Only subjects with paired samples were included in this analysis||participants|||Number
759945|NCT00629525|Primary|Biochemical Response Rate|Number of participants with 50% decline in serum PSA from baseline was pre-set as the primary measure of disease response.|Patients were followed for a median of 315 days|||participants|||Number
759946|NCT00629707|Secondary|Brain NAA/Creatine Ratio & Brain Lactate Measured by MR Spectroscopy, Cerebral Blood Flow & Oxygen Saturation Measured by MR Perfusion Weighted Imaging & Near Infrared Spectroscopy, Mental Status Evaluated by Glasgow Coma Scale Scores.||twice during DKA treatment, once at 3-6 hours and at 9-12 after treatment. A normal comparison measurement will be done after recovery from DKA, at least 72 hours after treatment||||||
759947|NCT00629707|Primary|Cerebral Edema Measured by MR Imaging (Apparent Diffusion Coefficient)|In both groups, brain Apparent Diffusion Coefficient (ADC) measures at 3-6 hours and 9-12 hours after beginning DKA treatment were averaged to determine overall brain ADC during DKA treatment. The brain ADC indicates the distribution of water in the brain and is an indicator of brain swelling (edema). The overall brain ADC values during DKA treatment were compared with the brain ADC measured after recovery to assess the degree of brain edema formation during DKA treatment. The difference in brain ADC, calculated as the averaged treatment values minus the recovery value, was used as the main outcome measure to indicate the degree of brain edema formation|twice during DKA treatment, once at 3-6 hours and at 9-12 after treatment. A normal comparison measurement will be done after recovery from DKA, at least 72 hours after treatment|Data from all enrolled participant that completed the study were analyzed.||mm^2/sec||Standard Deviation|Mean
759948|NCT00629772|Secondary|Mean Percent Improvement in Palmoplantar Psoriasis Surface Area (PPSA) at Week 26|Efficacy of infliximab administered for 22 weeks in patients who received infliximab at Day 0 by evaluating the improvement over time in percent PPSA from Day 0 to Week 26. The surface affected by psoriasis on palms and soles is estimated on the day of the visit as a percentage of the total surface of palms and soles affected by psoriasis. Each palm represents 20% and each sole 30%. As a rule of thumb half a palm equals 10% of the total surface area of palm and soles.|Baseline, 26 weeks|The analysis was performed on the intent to treat (ITT) population and the imputation technique was last observation carried forward (LOCF).||Percent improvement||Standard Deviation|Mean
760084|NCT00632749|Secondary|Cmax (Maximum Measured Concentration of Cytarabine in Plasma)|Cmax of Cytarabine after a 20 mg Subcutaneous Dose on the First Day of BI 811283|-0.05 hours before and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00 hours after administration of Cytarabine|Treated Set (Only patients with observed cases (OC) values were analysed)||ng/mL||Geometric Coefficient of Variation|Geometric Mean
759949|NCT00629772|Secondary|Mean Percent Improvement in Physician's Global Assessment (PGA) at Week 26|"Efficacy of infliximab administered for 22 weeks in patients who received infliximab at Day 0 by evaluating the improvement over time in Physician's Global Assessment (PGA) from Day 0 to Week 26.
0 = clear
1 = almost clear
2 = Mild
3 = Moderate
4 = Severe
5 = Very severe"|Baseline, 26 weeks|The analysis was performed on the intent to treat (ITT) population and the imputation technique was last observation carried forward (LOCF).||Percent improvement||Standard Deviation|Mean
759950|NCT00629772|Secondary|Mean Percent Improvement in Dermatology Life Quality Index (DLQI) at Week 26|"Efficacy of infliximab administered for 22 weeks in patients who received infliximab at Day 0 by evaluating the improvement over time in dermatology life quality index (DLQI) from Day 0 to Week 26.
Impact on quality of life with the DLQI. The aim of the questionnaire is to measure how much a patient's skin problem has affected their life over the previous week.
0-1 = no effect at all on patient's life
2-5 = small effect on patient's life
6-10 = moderate effect on patient's life
11-20 = very large effect on patient's life
21-30 = extremely large effect on patient's life"|Baseline, 26 weeks|The analysis was performed on the intent to treat (ITT) population and the imputation technique was last observation carried forward (LOCF).||Percent improvement||Standard Deviation|Mean
759951|NCT00629772|Secondary|Mean Percent Improvement in Modified Palmoplantar Pustulosis Area and Severity Index (m-PPPASI) at Week 26|"Efficacy of infliximab administered for 22 weeks in patients who received infliximab at Day 0 by evaluating the improvement over time in modified m-PPPASI from Day 0 to Week 26.
m-PPPASI = (E + I + D)Area X 0.2 (R palm) + (E + I + D) Area X 0.2 (L palm) + (E + I + D) Area X 0.3 (R sole) + (E + I + D) Area X 0.3 (L sole).
Erythema, induration and desquamation are evaluated on a scale of 0 to 4 while area is evaluated on a scale of 0 to 6. The m-PPPASI score can vary from 0 (absence of disease) to 72 (most severe palmoplantar psoriasis possible)."|Baseline, 26 weeks|The analysis was performed on the intent to treat (ITT) population and the imputation technique was last observation carried forward (LOCF).||Percent improvement||Standard Deviation|Mean
759952|NCT00629772|Secondary|Mean Physician's Global Assessment (PGA) at Week 14|"Efficacy by comparing the mean Physician's Global Assessment(PGA).
0 = clear.
1 = almost clear.
2 = Mild.
3 = Moderate.
4 = Severe.
5 = Very severe."|14 weeks|The analysis was performed on the intent to treat (ITT) population and the imputation technique was last observation carried forward (LOCF).||Units on a scale||Standard Deviation|Mean
759953|NCT00629772|Secondary|Mean Percent Palmoplantar Psoriasis Surface Area (PPSA) at Week 14|Efficacy by comparing the mean percent PPSA. The surface affected by psoriasis on palms and soles is estimated on the day of the visit as a percentage of the total surface of palms and soles affected by psoriasis. Each palm represents 20% and each sole 30%. As a rule of thumb half a palm equals 10% of the total surface area of palm and soles. A sole completely covered with psoriasis would have a PPSA of 30% (if the other sole and the palms are unaffected) while a palm completely covered with psoriasis would have a PPSA of 20% (if the other palm and the soles are unaffected).|14 weeks|The analysis was performed on the intent to treat (ITT) population and the imputation technique was last observation carried forward (LOCF).||Percentage of affected area||Standard Deviation|Mean
759954|NCT00629772|Secondary|Mean Dermatology Life Quality Index (DLQI) at Week 14|"Impact on quality of life with the Dermatology Life Quality Index (DLQI) The aim of the questionnaire is to measure how much a patient's skin problem has affected their life over the previous week.
0-1 = no effect at all on patient's life
2-5 = small effect on patient's life
6-10 = moderate effect on patient's life
11-20 = very large effect on patient's life
21-30 = extremely large effect on patient's life"|14 weeks|The analysis was performed on the intent to treat (ITT) population and the imputation technique was last observation carried forward (LOCF).||Units on a scale||Standard Deviation|Mean
759955|NCT00629772|Secondary|Number of Adverse Events at Week 14|Safety of infliximab administered for 14 weeks in patients who received by comparing adverse events|14 weeks|||Adverse Events|||Number
759956|NCT00629772|Primary|75% Improvement in Modified Palmoplantar Pustulosis Area and Severity Index (m-PPPASI) From Day 0|"Efficacy by comparing the number of patients reaching a 75% improvement in m-PPPASI (m-PPPASI 75) m-PPPASI = (E + I + D)Area X 0.2 (R palm) + (E + I + D) Area X 0.2 (L palm) + (E + I + D) Area X 0.3 (R sole) + (E + I + D) Area X 0.3 (L sole).
Erythema, induration and desquamation are evaluated on a scale of 0 to 4 while area is evaluated on a scale of 0 to 6. The m-PPPASI score can vary from 0 (absence of disease) to 72 (most severe palmoplantar psoriasis possible)."|14 weeks|The analysis was performed on the intent to treat (ITT) population. Nonresponder imputation (NRI) was used for patients who withdrew before the end of the study. They were treated as nonresponders from the point of withdrawal onward.||Participants|||Number
759957|NCT00621504|Secondary|Evaluate Safety||first dose, throughout the treatment period, and up to the TOC visit||||||
759958|NCT00621504|Secondary|Microbiological Re-infection/Recurrence at LFU||21 to 35 days after last dose of study drug||||||
759959|NCT00621504|Primary|Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at Test-of-Cure (TOC) in the Clinically Evaluable (CE) Population||8-15 days after last dose of study drug||||||
759960|NCT00621504|Secondary|Clinical Relapse at Late Follow Up (LFU)||21-35 days after last dose of study drug||||||
759961|NCT00621504|Secondary|Clinical and Microbiological Response by Pathogen at TOC||8-15 days after last dose of study drug||||||
759962|NCT00621504|Secondary|Overall (Clinical and Radiographic) Success Rate at Test of Cure (TOC)||8-15 days after last day of study drug||||||
759963|NCT00621504|Secondary|Microbiological Success Rate at Test of Cure (TOC)||8-15 days after last dose of study drug||||||
759964|NCT00621504|Secondary|Clinical Response at End of Therapy (EOT)||Last day of study drug administration||||||
759983|NCT00621686|Secondary|Time to Progression|Time to progression (TTP) is defined to be the length of time from study registration to a) date of disease progression as defined by section 11.0 of the protocol, or b) last follow-up. If a patient dies without documentation of disease progression, the patient will be considered to have had a tumor progression at the time of death unless there is sufficient documented evidence to conclude no progression occurred prior to death. Time to progression curves were compared via the log-rank test. Progression is defined as a >25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions or unequivocal increase in size of contrast enhancement or increase in mass effect as agreed upon independently by primary physician and quality control physicians: appearance of new lesions compared to pretreatment MRI and/or CT scan.|Time from study registration to a) date of disease progression, or b) last follow-up; Up to 15 years|||months||95% Confidence Interval|Median
759965|NCT00621504|Primary|Clinical Cure Rate at Test-of-Cure (TOC) in the Modified Intent-to-Treat Efficacy (MITTE) Populations|"Cure:Total resolution of all signs and symptoms of pneumonia (ie,CABP), or improvement to such an extent that further antimicrobial therapy was not necessary
Failure: Any of the following:
Persistence, incomplete clinical resolution, or worsening in signs and symptoms of CABP that required alternative antimicrobial therapy
Treatment-limiting adverse event (AE) leading to discontinuation of study drug therapy, when subject required alternative antimicrobial therapy to treat the pneumonia
Death wherein pneumonia (ie,CABP) was considered causative
Indeterminate: Inability to determine an outcome"|8 to 15 days after last dose of study drug|The MITTE Population consisted of all subjects in the MITT Population (all randomized subjects who received any amount of the study drug) in PORT Risk Class III or IV. The Pneumonia Outcomes Research Team (PORT) scale of CAP severity in which Risk Class I is associated with the lowest risk for mortality and Risk Class V represents the highest risk.||participants|||Number
759966|NCT00621517|Primary|Ordinal Scale(i.e., 1-8)of Symptom Severity||three weeks and six weeks||||||
759967|NCT00621517|Primary|Clinical Global Impression - Improvement Scale||three weeks and six weeks||||||
759968|NCT00621517|Primary|Change in International Restless Legs Syndrome Study Group (IRLSSG) Severity Scale.|Scale ranges from 0 to 40 points with higher scores being associated with more severe symptoms of restless legs syndrome. There are 10 questions, with points of 0 to 4 per question. The change in IRLSSG score from baseline is recorded at three and six weeks.|Baseline, three weeks, and six weeks|Intention to Treat||points on a scale||Standard Deviation|Mean
759969|NCT00621530|Secondary|Neuropathic Pain Symptom Inventory|Pain was assessed 2 days, and 2 and 6 months after surgery using a validated questionnaire to assess the degree of neuropathic characteristics of pain. This is termed the Neuropathic Pain Symptom Inventory which is scored 0-100 with 100 being the worst possible pain.|6 months|Some subjects were missed to follow up at different times||units on a scale||Standard Deviation|Mean
759970|NCT00621530|Secondary|McGill Affective Pain|Pain was assessed 2 days, and 2 and 6 months after surgery using a validated questionnaire wherein subjects rate the degree to which adjectives describe the emotional component of their pain experience. This is termed the McGill Pain Affective Score and is scored from 0 to 12 with 12 being the highest pain emotional impact.|6 months|Some subjects were missed to follow up at different times||units on a scale||Standard Deviation|Mean
759971|NCT00621530|Secondary|McGill Pain Intensity|Pain was assessed 2 days and 2 and 6 months after surgery using a validated questionnaire wherein subjects rate the degree to which adjectives describe the intensity of their pain experience. This is termed the McGill Pain Intensity Score and is scored from 0 to 33 with 33 being the highest pain intensity.|6 months|Some subjects were missed to follow up at different times||units on a scale||Standard Deviation|Mean
759972|NCT00621530|Secondary|Present Pain Intensity|Pain was assessed preoperatively, 2 days, and 2 and 6 months after surgery using a 0-10 (10 being worse) verbal Present Pain Intensity (PPI) scale|6 months|Some subjects were missed to follow up at different times||units on a scale||Standard Deviation|Mean
759973|NCT00621530|Primary|Area of Hypersensitivity to Mechanical Stimuli Surrounding the Wound 48 Hours After Surgery|Hyperalgesia (using a von Frey filament) and allodynia (using a cotton swab) were evaluated around the surgical site 48 hours after surgery.|48 hours|These are data from the 57 subjects who remained in the study at the time of the primary outcome measure 48 hr after surgery||area in centimeters squared||Full Range|Median
759974|NCT00621543|Secondary|Percentage of Women Continuing IUD Use at 3 Months||3 months|||percentage of participants||95% Confidence Interval|Mean
759975|NCT00621543|Primary|Percentage of Women With Expulsion of an Intrauterine Device (IUD) Placed After Medical Abortion.||Three months|||percentage of participants||95% Confidence Interval|Mean
759976|NCT00621582|Secondary|Physician Tolerability Assessment at Visit 3|The score is evaluated according to a 8-point scale(poor: 1-2, fair: 3-4, good: 5-6, excellent: 7-8)|8 weeks (Visit 3)|Full Analysis Set (FAS)||Participants|||Number
759977|NCT00621582|Primary|Patient Tolerability Assessment at Visit 3|"Patient tolerability assessment classified as Unsatisfied, Satisfied, Good and Very Good"|8 weeks (Visit 3)|Full Analysis Set (FAS)||Participants|||Number
759978|NCT00621582|Secondary|Physician Global Assessment of Spiriva Effectiveness at Visit 2 and Visit 3 (Number of Patients Whose Assessment Were Excellent and Good)|"The score is evaluated according to a 8-point scale(poor: 1-2, fair: 3-4, good: 5-6, excellent: 7-8;
Represents number of participants who score good and excellent at visit 2 (2 weeks) and visit 3 (8 weeks)"|2 weeks (Visit 2 and 8 weeks (Visit 3)|||Participants|||Number
759979|NCT00621582|Primary|Patient Global Assessment of Chronic Obstructive Pulmonary Disease (COPD) Symptom at Visit 1 and Visit 3 (Number of Patients Whose Assessment Were Excellent and Good)|"The score is evaluated according to a 8-point scale(poor: 1-2, fair: 3-4, good: 5-6, excellent: 7-8; 1 point meaning most COPD-associated symptoms and signs and 8 point meaning least).
Represents number of participants who score good and excellent at visit 1 (0 weeks) and visit 3 (8 weeks)"|0 weeks (Visit 1) and 8 weeks (Visit 3)|Sampling Method: Non-Probability Sample; conducted in primary care clinics.||Participants|||Number
759980|NCT00621621|Secondary|AV Block That Requires the Insertion of a Permanent Pacemaker: Defined as the Insertion of a Permanent Pacemaker, as Assessed During Defined Study Follow up.||After 250 subjects have been enrolled.|||participants||95% Confidence Interval|Number
759981|NCT00621621|Primary|Device or Procedure Related AV Block Persistent Through Discharge From Hospital.||After 250 subjects have been enrolled.|||participants||95% Confidence Interval|Number
759982|NCT00621686|Secondary|Overall Survival|Overall survival (OS) is defined as the length of time from date of registration to a) date of death due to any cause or b) last follow-up.|Time from date of registration to a) date of death due to any cause or b) last follow-up; Up to 15 years|||months||95% Confidence Interval|Median
759998|NCT00621842|Secondary|Number of Participants Who Fell at Least Once During the Study||12 weeks|The number of participants was chosen from the number who received at least one dose of lamotrigine.||participants|||Number
759999|NCT00621842|Secondary|Change in Body Weight From Baseline||12 weeks|The number of participants for analysis was determined by number of completers plus number of dropouts where the last known observation of a dropout taking lamotrigine was carried forward. Missing data and the lack of 3 participants completing more than the baseline assessment yielded a number for analysis that was less than total enrollment.||lbs.||95% Confidence Interval|Mean
759984|NCT00621686|Primary|6-month Progression-free Survival|Primary Endpoint: 6-month progression free survival (PFS6): The proportion of successes will be estimated using the binomial point estimator (number of successes divided by the total number of evaluable patients) and the binomial 95% confidence interval estimated. To be classified as a success, an evaluable patient must be alive and progression-free 6 months after registration to the study. Patients who die prior to 6 months after study registration will be considered to have failed. Progression is defined as a >25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions or unequivocal increase in size of contrast enhancement or increase in mass effect as agreed upon independently by primary physician and quality control physicians: appearance of new lesions compared to pretreatment MRI and/or CT scan.|at 6 months|||proportion of participants||95% Confidence Interval|Number
759985|NCT00621764|Other Pre-specified|Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine|Japanese Encephalitis virus neutralizing antibody measurement was assessed by the PRNT50 assay.|Day 0 (pre-vaccination) up to 5 years after final vaccination|Geometric Mean Titers Against JE Antibodies were assessed in the Full Analysis Set.||Titers||95% Confidence Interval|Geometric Mean
759986|NCT00621764|Other Pre-specified|Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination|Japanese Encephalitis virus neutralizing antibody measurement was assessed by the PRNT50 assay.|Day 0 (pre-vaccination) up to 5 years after final vaccination|Persistence of seroprotection to JE-CV antigens was assessed in the Full Analysis Set.||Participants|||Number
759987|NCT00621764|Secondary|Summary of Geometric Mean Titers Against JE Antibodies Before and After JE-CV Vaccination|JE virus neutralizing antibody measurement was assessed by the PRNT50 assay.|Day 0 (pre-vaccination) and Day 28 after final vaccination|Geometric mean titers against the JE-CV vaccine antigens were assessed in the Per-Protocol Analysis Set.||Titers||95% Confidence Interval|Geometric Mean
759988|NCT00621764|Secondary|Percentage of Participants With Seroconversion to JE-CV Vaccine Antigens Following Administration of JE-CV Vaccination|JE virus neutralizing antibody measurement was assessed by plaque reduction neutralization test (PRNT50). Seroconversion was defined as participants with a pre-vaccination titer < 10 (1/dil) and post-vaccination titer ≥ 10 (1/dil), or participants with pre-vaccination titer ≥ 10 (1/dil) and 4-fold increase from pre- to post-vaccination.|Day 0 (pre-vaccination) and Day 28 after final vaccination|Seroconversion to the JE-CV vaccine antigens was assessed in the Per-Protocol Analysis Set.||Percentage of participants|||Number
759989|NCT00621764|Primary|Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection|"12 to 24 months - Injection site: Tenderness, Erythema, and Swelling; Systemic reactions: Fever, Vomiting, Crying Abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3: Tenderness, Cries if limb is moved; Erythema and Swelling, ≥5 cm; Fever, >39.5˚C; Vomiting, ≥ 6 times/day; Abnormal crying, >3 hours; Drowsiness, Sleeping often; Appetite lost, Refuses ≥3 feeds/meals; Irritability, Inconsolable.
2 to 5 years - Injection site: Pain, Erythema, and Swelling; Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3: Pain, Incapacitating; Erythema and Swelling, ≥5 cm; Fever, >39˚C; Headache, Malaise, and Myalgia, Prevents activities."|Day 0 up to Day 14 post-vaccination|Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set, which includes all persons who received at least one dose of study vaccine. A participant in Group 1 was given JE-CV vaccine as the second vaccination in error; and counted for Group 2 for the safety outcome for the second injection.||Participants|||Number
759990|NCT00621764|Primary|Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection|"12 to 24 months - Injection site: Tenderness, Erythema, and Swelling; Systemic reactions: Fever, Vomiting, Crying Abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3: Tenderness, Cries if limb is moved; Erythema and Swelling, ≥5 cm; Fever, >39.5˚C; Vomiting, ≥ 6 times/day; Abnormal crying, >3 hours; Drowsiness, Sleeping often; Appetite lost, Refuses ≥3 feeds/meals; Irritability, Inconsolable.
2 to 5 years - Injection site: Pain, Erythema, and Swelling; Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3: Pain, Incapacitating; Erythema and Swelling, ≥5 cm; Fever, >39˚C; Headache, Malaise, and Myalgia, Prevents activities."|Day 0 up to Day 14 post-vaccination|Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set, which includes all persons who received at least one dose of study vaccine.||Participants|||Number
759991|NCT00621777|Secondary|Effect of Treatment With Varenicline Versus Placebo on Health-related Quality of Life Indices in Recently Abstinent Smokers With Schizophrenia or Bipolar Disorder||53 weeks||||||
759992|NCT00621777|Secondary|Safety and Tolerability of Extended Duration Pharmacotherapy When Added to Antipsychotic Medications in Schizophrenia Patients Who Have Recently Quit Smoking||53 weeks||||||
759993|NCT00621777|Primary|Rate of 7-day Point Prevalence Abstinence at the End of the Relapse Prevention Phase (Study Week 53) in the Extended Duration Pharmacotherapy Group vs. the Placebo Group||76 weeks|||participants|||Number
759994|NCT00621842|Secondary|Number of Participants Who Had a Fall That Required Medical Attention and Was Related to Lamotrigine||12 weeks|The number of participants was chosen from the number who received at least one dose of lamotrigine.||participants|||Number
759995|NCT00621842|Secondary|Number of Participants Who Had a Fall That Required Medical Attention||12 weeks|The number of participants was chosen from the number who received at least one dose of lamotrigine.||participants|||Number
759996|NCT00621842|Secondary|Change in or Appearance of Extrapyramidal Symptoms From Baseline Using the Barnes Akathisia Scale (BAS)|The minimum possible score is 0 and the maximum score is 5. A higher score implies a worse condition.|12 weeks|The number of participants for analysis was determined by number of completers plus number of dropouts where the last known observation of a dropout taking lamotrigine was carried forward. Missing data and the lack of 3 participants completing more than the baseline assessment yielded a number for analysis that was less than total enrollment.||units on a scale||95% Confidence Interval|Mean
759997|NCT00621842|Secondary|Change in Appearance of Extrapyramidal Symptoms From Baseline Using the Abnormal Involuntary Movement Scale (AIMS)|The minimum possible score is 0 and the maximum score is 4. A higher score implies a worse condition.|12 weeks|The number of participants for analysis was determined by number of completers plus number of dropouts where the last known observation of a dropout taking lamotrigine was carried forward. Missing data and the lack of 3 participants completing more than the baseline assessment yielded a number for analysis that was less than total enrollment.||units on a scale||95% Confidence Interval|Mean
760000|NCT00621842|Secondary|Change in or Appearance of Extrapyramidal Symptoms From Baseline Using the Simpson Angus Scale (SAS)|The minimum possible score is 0 and the maximum score is 4. A higher score implies a worse condition.|12 weeks|The number of participants for analysis was determined by number of completers plus number of dropouts where the last known observation of a dropout taking lamotrigine was carried forward. Missing data and the lack of 3 participants completing more than the baseline assessment yielded a number for analysis that was less than total enrollment.||units on a scale||95% Confidence Interval|Mean
760001|NCT00621842|Secondary|Change From Baseline in Overall Clinical Diagnosis Using the CGI-BP|The minimum possible score is 1 and the maximum score is 7. A higher score implies a worse condition.|12 weeks|The number of participants for analysis was determined by number of completers plus number of dropouts where the last known observation of a dropout taking lamotrigine was carried forward. Missing data and the lack of 3 participants completing more than the baseline assessment yielded a number for analysis that was less than total enrollment.||units on a scale||95% Confidence Interval|Mean
760002|NCT00621842|Secondary|Change in Manic Symptoms From Baseline Using the Young Mania Rating Scale (YMRS)|The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition.|12 weeks|The number of participants for analysis was determined by number of completers plus number of dropouts where the last known observation of a dropout taking lamotrigine was carried forward. Missing data and the lack of 3 participants completing more than the baseline assessment yielded a number for analysis that was less than total enrollment.||units on a scale||95% Confidence Interval|Mean
760003|NCT00621842|Secondary|Change in Depressive Symptoms From Baseline Using the Hamilton Depression Rating Scale (GRID-HAM-D)|The minimum possible score is 0 and the maximum score is 78. A higher score implies a worse condition.|12 weeks|The number of participants for analysis was determined by number of completers plus number of dropouts where the last known observation of a dropout taking lamotrigine was carried forward. Missing data and the lack of 3 participants completing more than the baseline assessment yielded a number for analysis that was less than total enrollment.||units on a scale||95% Confidence Interval|Mean
760004|NCT00621842|Secondary|Assessment of Adverse Effects With the Udvalg Fur Kliniske Undersogelser (UKU)|Frequency of adverse effects was measured using the UKU. The total number of adverse effects assessed by the UKU is 49 plus one open-ended question about any adverse effects not assessed.|12 weeks|The number of participants was chosen from the number who received at least one dose of lamotrigine.||participants|||Number
760005|NCT00621842|Primary|Assessment of Change in Depressive Symptoms From Baseline on the Montgomery Asberg Depression Rating Scale (MADRS)|The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition.|12 weeks|The number of participants for analysis was determined by number of completers plus number of dropouts where the last known observation of a dropout taking lamotrigine was carried forward. Missing data and the lack of 3 participants completing more than the baseline assessment yielded a number for analysis that was less than total enrollment.||units on a scale||95% Confidence Interval|Mean
760006|NCT00621855|Secondary|Laboratory Analyses|Number of patients with possible clinically significant abnormalities. Clinically significant abnormalities refers to the increase or decrease from baseline.|6 month treatment period + 2 week post treatment follow up|Treated set||participants|||Number
760007|NCT00621855|Secondary|Number of Participants With Bleeding Events During Total Observation Time|"International Society Thrombosis and Haemostasis (ISTH) definition of a major bleed, and clinically relevant minor bleed.
A bleeding event was considered as major if it was fatal, was a symptomatic bleeding in a critical area or organ (intracranial, intraspinal, intraocular, retroperitoneal, intra-articular, pericardial, or intramuscular with compartment syndrome), or caused a fall in haemoglobin level of ≥2 g/dL (≥1.24 mmol/L), or led to transfusion of ≥2 units of whole blood or red cells.
All non major bleeding events were classified as minor bleeds; minor bleeds were subdivided in clinically relevant minor bleeds (CRBE) and not clinically relevant minor bleeds. A CRBE was defined as an acute or subacute clinically overt bleed that did not meet the criteria of a major bleed but either lead to hospital admission and/or a physician guided medical or surgical treatment and/or a change in antithrombotic therapy (including interruption or discontinuation of study drug)."|6 month treatment period + 2 week post treatment follow up|Treated set||participants|||Number
760008|NCT00621855|Secondary|Change From Baseline in log10 D-dimer After 1 and 4 Weeks|Change from baseline in log10 D-dimer concentration after 1 and 4 weeks of dabigatran etexilate treatment compared to placebo. The standard deviation is the geometric standard deviation.|Baseline and at 1 week and 4 weeks|Full Analysis Set (FAS)||ratio||Standard Deviation|Geometric Mean
760009|NCT00621855|Secondary|Number of Participants With Any Reduction of D-dimer Concentration||at 1 week and 4 weeks|Full analysis set - The full analysis set includes all randomised and treated patients who had at least one post-dose assessment of D-dimer available.||participants|||Number
760010|NCT00621855|Secondary|Individual Occurrence of Death (Cardiovascular and All-cause), Non-fatal MI, Severe Recurrent Ischaemia and Non-haemorrhagic Stroke During Six Months of Treatment|Number of Participants with individual occurrence of death (cardiovascular and all-cause), non-fatal MI, severe recurrent ischaemia and non-haemorrhagic stroke during six months of treatment.|6 month treatment period + 2 week post treatment follow up|Treated set||participants|||Number
760011|NCT00621855|Secondary|Composite of Cardiovascular Death (CVD) With Non Fatal Myocardial Infarction (MI) and Non Haemorrhagic Stroke and All Cause Death (ACD), Non Fatal MI, Severe Recurrent Ischaemia (SRI) and Non Haemorrhagic Stroke During Six Months Treatment|Number of Participants with Composite of Cardiovascular death (CVD) with non fatal myocardial infarction (MI) and non haemorrhagic stroke and All cause death (ACD), non fatal MI, severe recurrent ischaemia (SRI) and non haemorrhagic stroke during six months treatment|6 month treatment period + 2 week post treatment follow up|Treated set||participants|||Number
760024|NCT00621959|Primary|Mean 24-hour Reflective Total 5 Symptoms Score (T5SS)|Total 5 Symptoms Score (T5SS) is the sum of rhinorrhea, sneezing, nasal congestion, itchy nose and itchy eyes scores. Each individual symptom was scored from 0 (none) to 3 (severe). The total score varies from 0 to 15.|Over the total treatment period (14 days)|Number of participants from the Intent-To-Treat (ITT) population with available T5SS over the Total Treatment Period||points on a scale||Standard Deviation|Mean
760144|NCT00633152|Secondary|The Safety of Ceftaroline Fosamil|Evaluate safety of Ceftaroline fosamil IM in adults with complicated skin and skin structure infection (cSSSI)|First dose of study drug through LFU Visit or 30 days after the last dose of study drug||||||
760012|NCT00621855|Primary|Number of Participants Displaying the Composite of Major and Clinically Relevant Minor Bleeding Events During Total Observation Time|"International Society Thrombosis and Haemostasis (ISTH) definition of a major bleed, and clinically relevant minor bleed.
A bleeding event was considered as major if it was fatal, was a symptomatic bleeding in a critical area or organ (intracranial, intraspinal, intraocular, retroperitoneal, intra-articular, pericardial, or intramuscular with compartment syndrome), or caused a fall in haemoglobin level of ≥2 g/dL (≥1.24 mmol/L), or led to transfusion of ≥2 units of whole blood or red cells.
All non major bleeding events were classified as minor bleeds; minor bleeds were subdivided in clinically relevant minor bleeds and not clinically relevant minor bleeds. A CRBE was defined as an acute or subacute clinically overt bleed that did not meet the criteria of a major bleed but either lead to hospital admission and/or a physician guided medical or surgical treatment and/or a change in antithrombotic therapy (including interruption or discontinuation of study drug)."|6 month treatment period + 2 week post treatment follow up|Treated set - The treated set includes all patients who received at least one dose of study medication.||participants|||Number
760013|NCT00621933|Secondary|Percentage of Staphylococcus Aureus Species Susceptible and Resistant to Oxacillin on the Conjunctiva|Percentage of staphylococcus aureus species susceptible and resistant to oxacillin on the conjunctiva. The minimum inhibitory concentrations (MIC) of each species were determined and compared to oxacillin MIC breakpoints. MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. For Staphylococcus aureus, the oxacillin MIC breakpoints were <= 2 ug/ml (susceptible) and >= 4 ug/ml (resistant).|Baseline|ITT population. All patients with cultures performed of the ocular surface.||Percentage of Species|||Number
760014|NCT00621933|Secondary|Percentage of Staphylococcus Aureus Species Susceptible and Resistant to Oxacillin on the Eyelid|Percentage of staphylococcus aureus species susceptible and resistant to oxacillin on the eyelid. The minimum inhibitory concentrations (MIC) of each species were determined and compared to oxacillin MIC breakpoints. MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. For Staphylococcus aureus, the oxacillin MIC breakpoints were <= 2 ug/ml (susceptible) and >= 4 ug/ml (resistant).|Baseline|ITT population. All patients with cultures performed of the ocular surface.||Percentage of Species|||Number
760015|NCT00621933|Primary|Percentage of Staphylococcus Epidermidis Species Susceptible and Resistant to Oxacillin on the Conjunctiva|Percentage of staphylococcus epidermidis species susceptible and resistant to oxacillin on the conjunctiva . The minimum inhibitory concentrations (MIC) of each species were determined and compared to oxacillin MIC breakpoints. MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. For Staphylococcus epidermidis, the oxacillin MIC breakpoints were <= 0.25 ug/ml (susceptible) and >= 0.50 ug/ml (resistant).|Baseline|ITT population. All patients with cultures performed of the ocular surface.||Percentage of Species|||Number
760016|NCT00621933|Primary|Percentage of Staphylococcus Epidermidis Species Susceptible and Resistant to Oxacillin on the Eyelid|Percentage of staphylococcus epidermidis species susceptible and resistant to oxacillin on the eyelid. The minimum inhibitory concentrations (MIC) of each species were determined and compared to oxacillin MIC breakpoints. MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. For Staphylococcus epidermidis, the oxacillin MIC breakpoints were <= 0.25 ug/ml (susceptible) and >= 0.50 ug/ml (resistant).|Baseline|ITT population. All patients with cultures performed of the ocular surface.||Percentage of Species|||Number
760017|NCT00621946|Primary|IDS-SR (Inventory of Depressive Symptomatology - Self-Report)|The IDS-SR is a 30 item (self-report questionnaire) designed to assess symptoms of depression. Scores range from 0 to 90. The higher the score, the worse the depressive symptoms (worse outcome).|Up to 12 weeks|||units on a scale||Standard Deviation|Mean
760018|NCT00621946|Primary|ACQ (Asthma Control Questionnaire)|The ACQ is a questionnaire used to assess symptoms pertinent to asthma management.Scores range from 0 to 42. The higher the score, the worse the asthma symptoms (worse outcome). The total ACQ score is obtained by dividing the raw score by the total number of items (in this case 7 items).|Up to 12 weeks|||units on a scale||Standard Deviation|Mean
760019|NCT00621946|Primary|HAM-D (Hamilton Rating Scale for Depression)|The HAM-D is a 17 item questionnaire (a clinician-administered depression scale) designed to evaluate severity of depressive symptoms. Scores can range from 0 to 52. The higher the score, the worse the depressive symptoms (worse outcome).|Up to 12 weeks|||units on a scale||Standard Deviation|Mean
760020|NCT00621946|Primary|IDS-SR (Inventory of Depressive Symptomatology - Self-Report)|The IDS-SR is a 30 item (self-report questionnaire) designed to assess symptoms of depression. Scores range from 0 to 90. The higher the score, the worse the depressive symptoms (worse outcome).|Baseline|||units on a scale||Standard Deviation|Mean
760021|NCT00621946|Primary|ACQ (Asthma Control Questionnaire)|The ACQ is a questionnaire used to assess symptoms pertinent to asthma management. Scores range from 0 to 42. The higher the score, the worse the asthma symptoms (worse outcome). The total ACQ score is obtained by dividing the raw score by the total number of items (in this case 7 items).|Baseline|||units on a scale||Standard Deviation|Mean
760022|NCT00621946|Primary|HAM-D (Hamilton Rating Scale for Depression)|The HAM-D is a 17 item questionnaire (a clinician-administered depression scale) designed to evaluate severity of depressive symptoms. Scores can range from 0 to 52. The higher the score, the worse the depressive symptoms (worse outcome).|Baseline|||units on a scale||Standard Deviation|Mean
760023|NCT00621959|Secondary|Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Overall health-related quality of life is expressed as the mean of the seven dimension scores. The overall RQLQ score varies from 0 to 6.|Baseline and endpoint, defined as the last available post-baseline observation during the two-week treatment period (in days)|Number of participants from the Intent-To-Treat (ITT) population with available overall RQLQ score at Endpoint visit and at Baseline||points on a scale||Standard Deviation|Mean
760042|NCT00632424|Secondary|Number of Participants With Hematology Laboratory Abnormalities|Laboratory results were graded according to CTC v 3.0. Hematology laboratory evaluations included absolute neutrophil count (ANC), white blood cell count (WBC), platelets (PLT), and hemoglobin (HGB).|From first study drug administration through 30 days post dose|All participants who received at least one dose of ixabepilone.||participants|||Number
760025|NCT00621985|Primary|Percent Difference in the Mean Log Transformed Area Under the Curve of 17-hydroxyprogesterone Between Regimens|Each subject was admitted for 2 24 hour hospitalizations, one on hydrocortisone and one on dexamethasone. Due to the timing of blood draws, the serum hormonal profile was only measured for 23 hours. The primary outcome was the Percent Difference in the Mean log transformed Area under the curve of 17-hydroxyprogesterone between the two regimens.|23 hours|Only four participants completed both the hydrocortisone and dexamethasone admissions.||Log Mean Area Under the Curve||Standard Deviation|Log Mean
760026|NCT00622167|Primary|Comparison of Plaque Characteristics Between DSCT (Dual Source Computed Tomography) and IVUS (Intravascular Ultrasound).|Characteristics include plaque cross-sectional diameter, area measurements, plaque volume, and plaque morphology (composition).|At time of imaging|Imaging 30 subjects was predicted to include enough plaques for analysis.||plaques|Participants||Number
760027|NCT00629850|Primary|Change in Negative Inspiratory Force Using a Pressure Manometer||10 weeks|there was only one participant completing this study. No analyses performed.||cmH2O|||Number
760028|NCT00629850|Primary|Change in Maximum Voluntary Ventilation Using Pulmonary Function Device|pulmonary function device measures flow rate in liters per minute|10 weeks|there was only one participant completing this study. No analyses performed.||liter per minute|||Number
760029|NCT00629850|Primary|Number of Participants With Improvement in Sleep Quality.|Improvement in sleep quality as defined by: less fragmented sleep, lower apnea hypopnea index (AHI), respiratory disturbance index (RDI) after device use.|10 weeks|There was only one participant completing the study. No analyses performed.||participants|||Number
760030|NCT00630058|Secondary|Antiviral Effects of TVR on HCV Were Assessed by Measuring Plasma HCV RNA Levels|HCV RNA concentrations were determined using the COBAS TaqMan HCV test (Roche Diagnostics). The linear dynamic range of the assay was 1.2–7.8 log10 IU/mL.|37 weeks|||Log IU / mL||Standard Deviation|Mean
760031|NCT00630058|Primary|T1/2(Time of Half-Life) of MP-424|"Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85.
Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57."|Data were collected at Day1 to Day85|||hours||Standard Deviation|Mean
760032|NCT00630058|Primary|Ctrough (Minimum Observed Concentration in Plasma) of MP-424|"Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85.
Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57."|Data were collected at Day1 to Day85|||μg/mL||Standard Deviation|Mean
760033|NCT00630058|Primary|AUC 0-8h (Area Under the Concentration-time Curve From Time Zero to 8 Hours) of MP-424|"Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85.
Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57."|Data were collected at Day1 to Day85|||μg/mL||Standard Deviation|Mean
760034|NCT00630058|Primary|Tmax (Time of Maximum Concentration in Plasma) of MP-424|"Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85.
Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57."|Data were collected at Day1 to Day85|||hours||Full Range|Median
760035|NCT00630058|Primary|Cmax (Maximum Observed Concentration in Plasma) of MP-424|"Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85.
Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57."|Data were collected at Day1 to Day85|||μg/mL||Standard Deviation|Mean
760036|NCT00632411|Primary|Continuous Smoking Abstinence|No smoking since 2 weeks after the target quit date|1 year||04/2017||||
760037|NCT00632411|Primary|Continuous Abstinence|No cigarette smoking since two weeks after the target quit date.|Measured at Year 1|Participants||Participants|||Count of Participants
760038|NCT00632424|Secondary|Best Overall Response|Tumor assessment was performed according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR) = disappearance of all clinical and radiological evidence of target lesions; Partial Response (PR) = at least 30% reduction in the sum of the longest diameter of all target lesions; Progressive disease (PD) = at least 20% increase in the sum of the longest diameter of all target lesions; Stable Disease (SD) = neither PR nor PD criteria were met.|Tumor assessments performed on Day 1 of every other cycle of therapy, until disease progression or toxicity|All treated participants who received at least one dose of ixabepilone were evaluable for tumor response.||participants|||Number
760039|NCT00632424|Secondary|PK: Mean Plasma Concentration Of Ixabepilone By Nominal Collection Time|Pharmacokinetics (PK) of ixabepilone were derived from plasma concentration versus time data. Individual patient PK parameter values were derived by standard non-compartmental methods by a validated pharmacokinetic analysis program. PK parameters include Cmax (maximum plasma concentration), Cmin (minimum plasma concentration), Tmax (time of maximum plasma concentration), AUC (0-TAU) (area under the curve in one dosing interval), T-half (plasma half-life).|Time 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 12.5, 13, 14, 15, 16, 17, 18, 20, 48, 72, and 168 hours post dose|Number of Participants Analyzed =All participants who received any treatment with ixabepilone and had adequate concentration profiles, n=all participants who received ixabepilone and had adequate concentration profiles at the specified time point. Cmax, Cmin, Tmax, AUC (0-TAU), and T-half were not calculated.||ng/ml||Standard Deviation|Mean
760040|NCT00632424|Secondary|Maximum QTc Interval on Day 1 and Maximum Change From Baseline for QTc Interval|QTc interval was defined as the measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle, corrected for heart rate|Baseline (Day -1) and Day 1|Since study NCT00632424 (CA163-149) was discontinued early due to variability in oral ixabepilone concentrations with the potential to negatively impact both safety and efficacy, QTc data were collected but not analyzed.|||||
760041|NCT00632424|Secondary|Number Of Participants With Liver Function and Renal Laboratory Abnormalities|Laboratory results were graded according to CTC v 3.0. Clinical laboratory evaluations included liver function (alanine aminotransferase [ALT], Aspartate aminotransferase [AST], alkaline phosphatase, and total bilirubin), and renal function (creatinine).|From first study drug administration through 30 days post dose|Since study NCT00632424 (CA163-149) was discontinued early due to variability in oral ixabepilone concentrations with the potential to negatively impact both safety and efficacy, liver and renal laboratory data were collected but not summarized.|||||
772074|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 3|Subject Satisfaction - ease of locating the deflation touch pads|3 months post-surgery|||% satisfactory or somewhat satisfactory|||Number
760043|NCT00632424|Secondary|Number of Participants With Most Common Treatment-Related Nonhematologic AEs (>25%)|AEs graded according to Common Terminology Criteria Version 3.0 (CTC v 3.0). AE=any new untoward medical occurrence or worsening of a pre-existing medical condition not necessarily having a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization/causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, or is an important medical event.|From first study drug administration through 30 days post dose|All participants who received at least one dose of ixabepilone.||participants|||Number
760044|NCT00632424|Secondary|Number of Participants With Adverse Event (AE), AE Leading to Discontinuation, Treatment-related AE, Treatment-related AE Leading to Discontinuation (DC), Most Common Treatment-Related Nonhematologic AE (>25%), Serious AE (SAE), or Treatment-related SAE|AEs graded according to Common Terminology Criteria Version 3.0 (CTC v 3.0). AE=any new untoward medical occurrence or worsening of a pre-existing medical condition not necessarily having a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization/causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, or is an important medical event.|From first study drug administration through 30 days post dose|All participants who received at least one dose of ixabepilone.||participants|||Number
760045|NCT00632424|Primary|Ixabepilone Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (R2PD)|The MTD was defined as the maximum dose which could be given to 6 participants such that not more than 1 participant experienced a DLT (or fewer than one-third if there were more than 6 treated participants) with at least 2 participants experiencing a DLT at the next higher dose level. The R2PD was to be based on the MTD and the assessment of any relevant chronic toxicities.|At the end of Cycle 1 (21 days).|Due to early study discontinuation, the MTD and RP2D of oral ixabepilone at the scheduled doses used in this study were not determined|||||
760046|NCT00632424|Primary|Number of Participants With a Dose-Limiting Toxicity (DLT)|DLT: any of the following, considered related to ixabepilone, occurring in Cycle 1: Absolute neutrophil count (ANC) <500 cells/mm^3 for ≥5 consecutive days or febrile neutropenia of any duration; Grade(Gr)4 thrombocytopenia <25,000 cells/mm^3 or Gr3 with bleeding requiring platelet transfusion; Gr3/4 nausea, vomiting, or diarrhea despite use of adequate intervention, fatigue, any other clinically significant drug-related ≥Gr 3 non-hematologic toxicity, delayed recovery (to Gr ≤1 or baseline, except alopecia) from toxicity which delays initiation of Cycle 2 by ≥3 weeks.|During Cycle 1 (Day 0 through Day 21)|All participants who received at least one dose of ixabepilone.||participants|||Number
760047|NCT00632463|Secondary|The Number of Patients Achieving at Least a 4-fold Increase in Serum RSV Neutralizing Antibody Titers||18 Days|||Participants|||Number
760048|NCT00632463|Secondary|Incidence of RSV Progression From Symptomatic Upper Respiratory Tract Infection to Lower Respiratory Tract Infection.||Study day 33|||Participants|||Number
760049|NCT00632463|Primary|Circulating RI-001 Titer|The primary endpoint of this study was the mean fold titer increase from baseline to Day 18 in circulating serum anti-RSV neutralizing antibody following treatment with RI-001.|Study day 18|||Fold Change||95% Confidence Interval|Mean
760050|NCT00632489|Primary|To Determine the Maximum Tolerated Doses (MTD) and Dose-limiting Toxicities (DLT) of LBH589 in Combination With Capecitabine When Administered to Patients With Refractory and Advanced Tumor Types That Are Sensitive to 5-fluorouracil|MTD for Panobinostat, twice weekly|18 months|||mg|||Number
760051|NCT00632489|Secondary|To Evaluate the Tolerability and Preliminary Efficacy of Established Doses of LBH589 and Capecitabine With Lapatinib in a Limited Number of Patients With HER2+ Breast Cancer||18 months||||||
760052|NCT00632489|Secondary|To Evaluate the Antitumor Activity of LBH589 in Combination With Capecitabine in Patients With Refractory and Advanced Tumors||18 months||||||
760053|NCT00632489|Primary|To Determine the Maximum Tolerated Doses (MTD) and Dose-limiting Toxicities (DLT) of LBH589 in Combination With Capecitabine When Administered to Patients With Refractory and Advanced Tumor Types That Are Sensitive to 5-fluorouracil|MTD for Capecitabine, BID|18 months|MTD Determination only for part I patients (per protocol)||mg/m2|||Number
760054|NCT00632502|Secondary|Maximum Plasma Concentration of Navarixin (Cmax)|Plasma samples were to be collected at baseline and up to 24 hours after dosing with navarixin at Weeks 1, 2, 3, and 4|Week 1, 2, 3, and 4|The analysis population was to include all participants who received at least one dose of navarixin and had navarixin plasma concentrations available for endpoint evaluation. The planned outcome measure was not evaluated.|||||
760055|NCT00632502|Secondary|Number of Participants Who Discontinued Treatment Because of an Adverse Event or a Protocol-defined Clinical Event|An AE is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. AEs may include the onset of new illness and the exacerbation of pre-existing conditions. A protocol-defined clinical event is an asthma exacerbation requiring addition of or increase in systemic steroids, as determined by the investigator.|Up to 4 weeks|The analysis population included all participants who received at least one dose of study drug||Participants|||Number
760056|NCT00632502|Secondary|Number of Participants Who Discontinued the Study Because of an Adverse Event|An AE is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. AEs may include the onset of new illness and the exacerbation of pre-existing conditions.|Up to 5 weeks|The analysis population included all participants who received at least one dose of study drug||Participants|||Number
760057|NCT00632502|Secondary|Number of Participants With a Laboratory Adverse Event|The endpoint measured was any laboratory (hematology, blood chemistry, or urinalysis) abnormality that was reported as an AE. An AE is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. AEs may include the onset of new illness and the exacerbation of pre-existing conditions.|Up to 5 weeks|The analysis population included all participants who received at least one dose of study drug||Participants|||Number
760145|NCT00633152|Secondary|The Microbiological Reinfection or Recurrence at the Late Follow-up (LFU) Visit|Evaluate per-subject reinfection or recurrence rate at the LFU Visit in those subjects who had a favorable microbiological outcome (eradication or presumed eradication) at the TOC Visit.|LFU Visit (21 to 35 days after end of therapy)||||||
760058|NCT00632502|Secondary|Number of Participants With an Electrocardiogram Adverse Event|The endpoint measured was any electrocardiogram abnormality that was reported as an AE. An AE is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. AEs may include the onset of new illness and the exacerbation of pre-existing conditions.|Week 4|The analysis population included all participants who received at least one dose of study drug||Participants|||Number
760059|NCT00632502|Secondary|Number of Participants With an Adverse Event (AE)|An AE is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. AEs may include the onset of new illness and the exacerbation of pre-existing conditions.|Up to 5 weeks|The analysis population included all participants who received at least one dose of study drug||Participants|||Number
760060|NCT00632502|Secondary|Change From Baseline in Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ[S])|The AQLQ[S] was administered at Baseline and at Weeks 2 and 4. The assessment consists of a 32-item questionnaire covering 4 domains: symptoms, emotional functioning, impact of environmental stimuli, and activity limitation. Each item receives a score from 1 (worst, or most affected) to 7 (not at all affected). The score is the mean across all items, and ranges from 1 to 7. The mean change from baseline is based on the average change over all post-baseline assessments.|Baseline and up to 4 weeks|The analysis population included all randomized participants who received at least one dose of study drug and had endpoint evaluation at Baseline or at any post-baseline visit||Score on a scale||Standard Deviation|Mean
760061|NCT00632502|Secondary|Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in One Second (FEV1)|Spirometry was used to measure post-bronchodilator FEV1 at Baseline and before study drug administration at Weeks 1, 2, 3, and 4. Participants received 4 puffs of bronchodilator (salbutamol hydrofluoroalkane or equivalent) at 30-second intervals and spirometry was performed 30 minutes later. The mean change from baseline is based on the average change over all post-baseline assessments.|Baseline and up to 4 weeks|The analysis population included all randomized participants who received at least one dose of study drug and had endpoint assessment at Baseline or at any post-baseline visit||Liters||Standard Deviation|Mean
760062|NCT00632502|Secondary|Mean Change From Baseline in Total Asthma Symptom Score|Total Asthma Symptom Score is the sum of individual symptoms of wheezing, coughing, and dyspnea assessed twice daily (morning and evening) and is recorded on a comment diary card. Each of the symptoms receives a daily score from 0 (none) to 3 (severe), averaged over the two daily assessments. The total score ranges from 0 to 9, with a lower score indicating less severe asthma symptoms.|Baseline and Weeks 1, 2, 3, and 4|The analysis population included all randomized participants who received at least one dose of study drug and had Asthma Symptom Scores evaluated at the time points reported||Score on a scale||Standard Deviation|Mean
760063|NCT00632502|Secondary|Mean Change From Baseline in Sputum Absolute Neutrophil Count|Induced sputum samples were obtained at Baseline and at Weeks 2 and 4 of the treatment period. Samples were collected before study drug administration using the nebulizer method and sent to a central laboratory for analysis. An average was taken over all post-baseline samples collected no later than one day after the last dose of study drug.|Baseline and while on study drug (up to 4 weeks)|The analysis population included all randomized participants who received at least one dose of study drug and had sputum absolute neutrophil counts at Baseline or Week 4||Neutrophil count X10^9/L||Standard Deviation|Mean
760064|NCT00632502|Primary|Number of Participants Who Maintained an Absolute Peripheral Blood Neutrophil Count >=1500/µL|Peripheral blood neutrophil counts were performed on Day 2 and Weeks 1, 2, 3, and 4 of the treatment period|Up to 4 weeks|The analysis population included all participants who received at least one dose of study drug||Number of participants|||Number
760065|NCT00632541|Secondary|Determine the Adverse Event Profile of Sorafenib Combined With Bevacizumab in This Patient Population.||24 months||||||
760066|NCT00632541|Secondary|Assess the Overall Response Rate.||24 months||||||
760067|NCT00632541|Secondary|Assess the Clinical Benefit Response: the Proportion of Patients With Clinical Benefit (CR+PR+SD > 6 Months Duration) Will be Assessed at the Completion of the Study.||6 months||||||
760068|NCT00632541|Primary|Progression-Free Survival|The primary objective was to assess the Progression-Free Survival of sorafenib combined with bevacizumab in patients with metastatic breast cancer. Progression is defined by RECIST as a 20% increase in the sum of the longest diameters of target measurable lesions over the smallest sum observed (over baseline if no decrease during therapy) or by the appearance of a new lesion.|From the start of the treatment until the criteria for disease progression is met (or death occurs) maximum of 24 months|||months||95% Confidence Interval|Median
760069|NCT00632619|Secondary|Disruptive Behavior Disorder Scale Score for ODD Symptoms|parents rating all DSM symptoms of Oppositional Defiant Disorder on a 0-3 severity scale with higher scores indicating more severe symptoms and range is from 0-27 (8 DSM IV items and I item from DSM 3R)|week 12 (endpoint)|all subjects who were successfully stabilized on stimulant medication and then entered therapy phase; subjects not able to tolerate stimulant med for ADHD or whose mood symptoms resolved with optimization of their stimulant dose were not included in the therapy phase.||units on a scale||Standard Deviation|Mean
760070|NCT00632619|Secondary|Children's Depression Rating Scale-Revised (CDRS-R) Total Score|rates 17 items of depression on a severity scale using information obtained from parent and child. Higher numbers indicate more severity symptoms and range is from 17 to 113.|Measured at Week 12 (endpoint)|all subjects who were successfully stabilized on stimulant medication and then entered therapy phase; subjects not able to tolerate stimulant med for ADHD or whose mood symptoms resolved with optimization of their stimulant dose were not included in the therapy phase.||units on a scale||Standard Deviation|Mean
760071|NCT00632619|Secondary|Disruptive Behavior Disorder Scale Score for ADHD Symptoms|sum of severity rating for all 18 DSM (Diagnostic and Statistics Manual for Mental Disorders) IV ADHD symptoms and two from DSM 3R on a 0 to 3 scale obtained from parent rating; range is from 0 to 60 with higher numbers indicating more severe symptoms|Measured at Week12 (endpoint)|all subjects who were successfully stabilized on stimulant medication and then entered therapy phase; subjects not able to tolerate stimulant med for ADHD or whose mood symptoms resolved with optimization of their stimulant dose were not included in the therapy phase.||units on a scale||Standard Deviation|Mean
765434|NCT00677820|Secondary|Number of Subjects Reporting Any Adverse Event (AE) Post-treatment||Days 0-7|Subjects who received any study vaccine and experienced any follow-up for safety were considered evaluable for safety.||participants|||Number
760072|NCT00632619|Primary|Mood Severity Index Measures Severity of Mood Symptoms (MSI).Range of 0-116; Clinicians Give to Parents and Child to Get Composite Score; Higher Scores=Greater Severity; 0-10=no Symptoms, 11-20=Mild Symptoms, 21to 35 =Moderate Symptoms and >35 is Severe|averaged Composite of endpoint ratings from the Children's Depression Rating Scale (CDRS used to measure depressive symptoms) and Young mania rating scale (MRS used to measure manic like symptoms) that has been used before as primary outcome in treatment studies of children with a mixture of affective symptoms (Fristad, et al., 2009). Prior to commencement of data collection, we elected to use it as the primary mood measure for the therapy phase of the trial over the initially selected YMRS as subjects either had to have elevations on the YMRS or CDRS but not necessarily both to be eligible. Hence, some subjects had very low YMRS scores at baseline which is why we chose the MSI over the YMRS.|measured at week 12 (endpoint)|all subjects who were successfully stabilized on stimulant medication and then entered therapy phase; subjects not able to tolerate stimulant med for ADHD or whose mood symptoms resolved with optimization of their stimulant dose were not included in the therapy phase.||units on a scale||Standard Deviation|Mean
760073|NCT00632619|Secondary|Young Mania Rating Scale (YMRS) Score|rates manic like symptoms in children; 7 items ranging from 0-4 and 4 items on a 0-8 scale; higher scores indicate more severe symptom severity (min total score=0, max=60). There are no subscales. Symptom severity information is obtained from direct interview of parent and child. It was initially selected as the primary outcome but prior to commencement of data collection the Mood Severity Index (MSI) was chosen instead based on recently published work in a related study (see above).|Measured at weeks 12 (endpoint)|all subjects who were successfully stabilized on stimulant medication and then entered therapy phase; subjects not able to tolerate stimulant med for ADHD or whose mood symptoms resolved with optimization of their stimulant dose were not included in the therapy phase.||units on a scale||Standard Deviation|Mean
760074|NCT00632632|Primary|Clinician Administered PTSD Scale(CAPS)|"Total CAPS severity score range is 0-136. Higher values represent a worse outcome (i.e. greater severity of posttraumatic symptoms). CAPS consists of 3 subscales, which are combined to form a total severity score.
Subscales:
CAPS cluster B (reexperiencing symptoms, range 0-40) CAPS cluster C (avoidance and numbing symptoms, range 0-56) CAPS cluster D (hyperarousal symptoms, range 0-40)"|6-months follow-up|||units on a scale||Standard Deviation|Mean
760075|NCT00632632|Secondary|Structured Clinical Interview for DSM-IV - Major Depressive Disorder (SCID-MDD)|Structured Clinical Interview for DSM-IV - Major Depressive Disorder is a clinical interview to assess presence/absence of Major Depressive Disorder.|Immediately following treatment|||percentage of MDD remission|||Number
760076|NCT00632632|Primary|Clinician Administered PTSD Scale(CAPS)|"Total CAPS severity score range is 0-136. Higher values represent a worse outcome (i.e. greater severity of posttraumatic symptoms). CAPS consists of 3 subscales, which are combined to form a total severity score.
Subscales:
CAPS cluster B (reexperiencing symptoms, range 0-40) CAPS cluster C (avoidance and numbing symptoms, range 0-56) CAPS cluster D (hyperarousal symptoms, range 0-40)"|Immediately following treatment|||units on a scale||Standard Deviation|Mean
760077|NCT00632736|Secondary|Number of Participants With the Indicated Response to the Patient Preference Question at Week 4 and Week 26|"The patient preference question assessed the participant's preference for either dosing regimen of study drug, once a day versus three times a day. Participants were asked to respond to the following question to assess preference: Please indicate whether you preferred taking your Parkinson's tablets 3 times a day or once a day. Wk, Week."|Week 4 and Week 26|All participants enrolled into this study from parent study 101468/168 who received at least one dose of study medication. Only 74 participants completed this questionnaire at Week 4, whereas 87 participants completed this questionnaire at Week 26.||participants|||Number
760078|NCT00632736|Primary|Number of Participants With the Indicated Number of Adverse Events (AEs) and Serious Adverse Events (SAEs)|AEs, defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, were collected to obtain data on the safety, tolerability, and benefit of ropinirole XL. SAEs, defined as AEs that are fatal, life threatening, disabling/incapacitating, resulting in hospitalization or prolongation of a hospital stay, a congenital abnormality/birth defect, or any important medical occurrence that the investigator regards as serious based on medical judgment, were also collected. st. med., study medication.|13 February 2004 through 31 March 2010|Safety Population: all participants who received at least one dose of study medication||participants|||Number
760079|NCT00632749|Secondary|Pharmacokinetics of Cytarabine After a Single Dose and at Steady State When Given Alone|"The study protocol originally included a phase II part with a treatment arm in which Cytarabine was given alone, however the sponsor discontinued the clinical development of BI 811283, therefore the protocol was amended and the reference therapy arm was removed from the study protocol” -> (Protocol Amendment 5, version 19 -May-2010, approved 28-Jun-2010).
Since there was never a treatment arm in which Cytarabine was given alone; hence pharmacokinetics are not calculated."|-0.05, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00 hours|Treated set|||||
760080|NCT00632749|Secondary|Pharmacodynamic Monitoring|"Pharmacodynamic monitoring: drug effect on leukaemia cells (e.g. polyploidy, histone H3 phosphorylation, morphologic changes).
An evaluation of this secondary endpoint is not possible due to missing samples / samples of poor quality of the provided material."|On Day 5, i.e. 72 hours after the end of the first BI 811283 infusion, and on Day 28 in the first cycle only|Treated set|||||
760081|NCT00632749|Secondary|AUC (0-tz) (Area Under the Concentration-time Curve of Cytarabine in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point)|AUC (0-tz) of Cytarabine after a 20 mg Subcutaneous Dose on the First Day of BI 811283|-0.05 hours before and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00 hours after administration of Cytarabine|Treated Set (Only patients with observed cases (OC) values were analysed)||ng·h/L||Geometric Coefficient of Variation|Geometric Mean
760082|NCT00632749|Secondary|AUC (0-inf) (Area Under the Concentration-time Curve of Cytarabine in Plasma Over the Time Interval From 0 Extrapolated to Infinity)|AUC (0-inf) of Cytarabine after a 20 mg Subcutaneous Dose on the First Day of BI 811283|-0.05 hours before and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00 hours after administration of Cytarabine|Treated set (Only patients with observed cases (OC) values were analysed)||ng·h/mL||Geometric Coefficient of Variation|Geometric Mean
760083|NCT00632749|Secondary|Tmax (Time From Dosing to Maximum Measured Concentration of Cytarabine in Plasma)|Tmax of Cytarabine after a 20 mg Subcutaneous Dose on the First Day of BI 811283|-0.05 hours before and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00 hours after administration of Cytarabine|Treated Set (Only patients with observed cases (OC) values were analysed)||hours||Full Range|Median
760085|NCT00632749|Secondary|Tmax,ss (Time From Dosing to Maximum Measured Concentration of BI 811283 in Plasma at Steady State)|tmax,ss (time from dosing to maximum measured concentration of BI 811283 in plasma at steady state) during Cycle 1|-0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283|Treated set (Only patients with observed cases (OC) values were analysed). Steady state analyses is not applicable for Treatment Schedule B, since pharmacokinetic analyses was performed after a single dose for Treatment Schedule B.||hours||Full Range|Median
760086|NCT00632749|Secondary|Tmax (Time From Dosing to Maximum Measured Concentration of BI 811283 in Plasma)|tmax (time from dosing to maximum measured concentration of BI 811283 in plasma) during Cycle 1|-0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283|Treated Set (Only patients with observed cases (OC) values were analysed)||hours||Full Range|Median
760087|NCT00632749|Secondary|AUC (0-tz,ss) (Area Under the Concentration-time Curve of BI 811283 in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point) at Steady State|AUC (0-tz,ss) (area under the concentration-time curve of BI 811283 in plasma over the time interval from 0 to the time of the last quantifiable data point) at steady state during Cycle 1|-0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283|Treated set (Only patients with observed cases (OC) values were analysed). Steady state analyses is not applicable for Treatment Schedule B, since pharmacokinetic analyses was performed after a single dose for Treatment Schedule B.||nmol·h/L||Geometric Coefficient of Variation|Geometric Mean
760088|NCT00632749|Secondary|AUC (0-inf, ss)(Area Under the Concentration-time Curve of BI 811283 in Plasma Over the Time Interval From 0 Extrapolated to Infinity) at Steady State|AUC (0-inf, ss)(area under the concentration-time curve of BI 811283 in plasma over the time interval from 0 extrapolated to infinity) at steady state during Cycle 1|-0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283|Treated set (Only patients with observed cases (OC) values were analysed). Steady state analyses is not applicable for Treatment Schedule B, since pharmacokinetic analyses was performed after a single dose for Treatment Schedule B.||nmol·h/L||Geometric Coefficient of Variation|Geometric Mean
760089|NCT00632749|Secondary|Cmax,ss (Maximum Measured Concentration of BI 811283 in Plasma at Steady State)|Cmax (maximum measured concentration of BI 811283 in plasma at steady state) during Cycle 1|-0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283|Treated set (Only patients with observed cases (OC) values were analysed). Steady state analyses is not applicable for Treatment Schedule B, since pharmacokinetic analyses was performed after a single dose for Treatment Schedule B.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
760090|NCT00632749|Secondary|AUC0-tz (Area Under the Concentration-time Curve of BI 811283 in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point)|AUC0-tz (area under the concentration-time curve of BI 811283 in plasma over the time interval from 0 to the time of the last quantifiable data point) during Cycle 1|-0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283|Treated Set (Only patients with observed cases (OC) values were analysed)||nmol·h/L||Geometric Coefficient of Variation|Geometric Mean
760091|NCT00632749|Secondary|AUC(0-inf) (Area Under the Concentration-time Curve of BI 811283 in Plasma Over the Time Interval From 0 Extrapolated to Infinity)|AUC(0-inf) (area under the concentration-time curve of BI 811283 in plasma over the time interval from 0 extrapolated to infinity) during Cycle 1|-0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283|Treated set (Only patients with observed cases (OC) values were analysed)||nmol·h/L||Geometric Coefficient of Variation|Geometric Mean
760092|NCT00632749|Secondary|Cmax (Maximum Measured Concentration of BI 811283 in Plasma)|Cmax (maximum measured concentration of BI 811283 in plasma) during Cycle 1|-0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283|Treated Set (Only patients with observed cases (OC) values were analysed)||nmol/L||Geometric Coefficient of Variation|Geometric Mean
760093|NCT00632749|Secondary|Overall Survival (OS)|OS was defined for all patients that entered the trial, and measured from the date of randomization until death from any cause.|Data collected up to cut-off date 20 Oct 2011, Up to 1239 days|Treated set||days||Standard Deviation|Mean
760094|NCT00632749|Secondary|Remission Duration|Remission duration analysis was defined only for patients who achieved CR, and was measured from the date of attaining CR until the date of disease recurrence (relapse). For patients who died without report of relapse, remission duration was censored on the date of death, regardless of the cause.|Data collected up to cut-off date 20 Oct 2011, Up to 1239 days|Treated set (Only patients with observed cases (OC) values were analysed)||days||Standard Deviation|Mean
760095|NCT00632749|Secondary|Relapse Free Survival|"Relapse-free survival was defined only for patients who achieved CR/CRi and was measured from the date of attaining CR/CRi until the date of recurrence or death from any cause, whichever occurred first.
Number of patients having relapse free survival are presented."|Data collected up to cut-off date 20 Oct 2011, Up to 1239 days|Treated set (Only patients with observed cases (OC) values were analysed)||participants|||Number
760096|NCT00632749|Secondary|Event Free Survival (EFS)|EFS was defined as the duration of time from randomisation to time of treatment failure (i.e. PD), relapse from CR, or death from any cause, whichever came first.|Data collected up to cut-off date 20 Oct 2011, Up to 1239 days|Treated set||days||Standard Deviation|Mean
760097|NCT00632749|Secondary|Partial Remission|"Response to treatment was evaluated according to the following criteria (modified from the National Cancer Institute/Cancer and Leukemia Group B criteria; The best overall response was defined as the best overall response recorded during the time period from the start of the treatment until the end of the treatment period, progression or death (whichever was earlier). Possible categories for best overall response were CR, CRi, Partial remission (PR), no change (NC), Progressive disease (PD) and no assessment.
Partial remission (PR). All of the criteria for CR had to be met, except that the bone marrow had to contain ≥ 5% but less than 25% blasts (or ≤ 50% of initial blast count), or < 5% blasts in the presence of Auer rods or abnormal morphology."|Data collected up to cut-off date 20 Oct 2011, Up to 1239 days|Treated set||participants|||Number
760098|NCT00632749|Secondary|Incidence of Dose Limiting Toxicity (DLT)|Number of participants with DLT in the first cycle (28 days) for the determination of the maximum tolerated dose (MTD)|up to 28 days of treatment|Treated set||participants|||Number
760099|NCT00632749|Secondary|Incidence and Intensity of AEs Graded According to CTCAE (Version 3.0)|"The severity and timing of AEs indicates how well the treatment regimen was tolerated.
Toxicities were evaluated using the common terminology criteria for adverse events (CTCAE) grading scheme."|Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days|Treated set||participants|||Number
760100|NCT00632749|Secondary|Response (Complete Remission [CR], Complete Remission With Incomplete Blood Count Recovery [CRi])|"Response to treatment was evaluated according to the following criteria (modified from the National Cancer Institute/Cancer and Leukemia Group B criteria:
The best overall response was defined as the best overall response recorded during the time period from the start of the treatment until the end of the treatment period, progression or death (whichever was earlier). Possible categories for best overall response were CR, CRi, Partial remission (PR), no change (NC), Progressive disease (PD) and no assessment.
Complete remission (CR): morphologically leukaemia free state (i.e. bone marrow with < 5% blasts by morphologic criteria and no Auer rods, no evidence of extramedullary leukaemia) and absolute neutrophil count ≥ 1,000/μL and platelets > 100,000/μL.
Complete remission with incomplete blood count recovery (“incomplete” CR, CRi).All of the above criteria for CR had to be met, except that neutrophils < 1,000/μL or platelets < 100,000/μL in the blood."|Data collected up to cut-off date 20Oct2011, Up to 1239 days|Treated set||participants|||Number
760101|NCT00632749|Primary|The Maximum Tolerated Dose (MTD) of 2 Schedules of BI 811283 in Combination With Cytarabine.|"The MTD was defined as the highest dose at which 6 patients were treated and less than 2 patients who experienced a dose limiting toxicities (DLT) within the first cycle of treatment.The MTD was defined based on safety data from the first cycle only.
It was determined using a standard “3 + 3 design with de-escalation”."|up to 28 days of treatment|Treated set (TS): All patients who received at least one single dose of trial medication (BI 811283 or cytarabine) were considered.||mg|||Number
760102|NCT00632814|Secondary|Haemo-QoL Standardized Total Score (Completed by Parents/Caregivers in the Total Group) at 9 Months of Treatment|Quality of life (QoL) was measured by the Haemo-QoL standardized total Score, which ranged from 0 (the best condition) to 100 (the worst condition).|9 months|Participants who completed the questionnaire.||Scores on a scale||Standard Deviation|Mean
760103|NCT00632814|Secondary|Haemo-QoL Standardized Total Score at 9 Months of Treatment (Completed by Participants in the Total Group)|Quality of life (QoL) was measured by the Haemo-QoL standardized total Score, which ranged from 0 (the best condition) to 100 (the worst condition).|9 months|Participants who completed the questionnaire.||Scores on a scale||Standard Deviation|Mean
760104|NCT00632814|Secondary|Change From Baseline in Stockholm Hemophilia Joint Score at 9 Months of Treatment|The assessment of joint function using Stockholm Joint Score. The minimum value is 0 (the best condition), and the maximum value is 140 (the worst condition).|baseline and 9 months|||Scores on a scale||Standard Deviation|Mean
760105|NCT00632814|Secondary|Actual Monthly rFVIII-FS Consumption||Up to 9 months|||IU/kg||Standard Deviation|Mean
760106|NCT00632814|Secondary|Number of Participants in Each Group at the End of the Study||Up to 9 months|Participants were allowed to switch treatment groups upon occurrence of joint bleed. Therefore the number of participants per group at the end of the study is different from the number of participants per group at baseline.||Participants|||Number
760107|NCT00632814|Secondary|Number of Participants With Joint Bleeds During the 9-month Treatment Period||Up to 9 months|||Participants|||Number
760108|NCT00632814|Secondary|Number of Participants With Bleeding Events During the 9-month Treatment Period||Up to 9 months|||Participants|||Number
760109|NCT00632814|Secondary|Number of Bleeds Per Participant During the 9-month Treatment Period||Up to 9 months|||bleeds per participant||Full Range|Median
760110|NCT00632814|Primary|Percentage of Participants With Less Than 2 Joint Bleeds During the 9-month Treatment Period||Up to 9 months|||Percentage of participants|||Number
760111|NCT00632931|Primary|Change From Baseline in QTcF at 24 Hours|The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value.|Baseline and 24 hours|"All patients as treated population in Part 1 of the Study;
22 patients had QTcF data from the vorinostat period (One patient with protocol violation, and two patients without predose measurements were excluded) and 23 patients had QTcF data from the placebo period (one patient with protocol violation and one patient who discontinued were excluded)"||milliseconds||95% Confidence Interval|Mean
760112|NCT00632931|Primary|Change From Baseline in QTcF at 12 Hours|The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value.|Baseline and 12 hours|"All patients as treated population in Part 1 of the Study;
22 patients had QTcF data from the vorinostat period (One patient with protocol violation, and two patients without predose measurements were excluded) and 23 patients had QTcF data from the placebo period (one patient with protocol violation and one patient who discontinued were excluded)"||milliseconds||95% Confidence Interval|Mean
760113|NCT00632931|Primary|Change From Baseline in QTcF at 8 Hours|The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value.|Baseline and 8 hours|"All patients as treated population in Part 1 of the Study;
22 patients had QTcF data from the vorinostat period (One patient with protocol violation, and two patients without predose measurements were excluded) and 23 patients had QTcF data from the placebo period (one patient with protocol violation and one patient who discontinued were excluded)"||milliseconds||95% Confidence Interval|Mean
760114|NCT00632931|Primary|Change From Baseline in QTcF at 4 Hours|The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The placebo-corrected change from baseline in QTcF was calculated by subtracting the QTcF change from baseline for placebo at each timepoint from the QTcF change from baseline for vorinostat at each timepoint.|Baseline and 4 hours|"All patients as treated population in Part 1 of the Study;
22 patients had QTcF data from the vorinostat period (One patient with protocol violation, and two patients without predose measurements were excluded) and 23 patients had QTcF data from the placebo period (one patient with protocol violation and one patient who discontinued were excluded)"||milliseconds||95% Confidence Interval|Mean
760115|NCT00632931|Primary|Change From Baseline in QTcF at 3 Hours|The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value.|Baseline and 3 hours|"All patients as treated population in Part 1 of the Study;
22 patients had QTcF data from the vorinostat period (One patient with protocol violation, and two patients without predose measurements were excluded) and 23 patients had QTcF data from the placebo period (one patient with protocol violation and one patient who discontinued were excluded)"||milliseconds||95% Confidence Interval|Mean
760116|NCT00632931|Primary|Change From Baseline in QTcF at 2 Hours|The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value.|Baseline and 2 hours|"All patients as treated population in Part 1 of the Study;
22 patients had QTcF data from the vorinostat period (One patient with protocol violation, and two patients without predose measurements were excluded) and 23 patients had QTcF data from the placebo period (one patient with protocol violation and one patient who discontinued were excluded)"||milliseconds||95% Confidence Interval|Mean
760117|NCT00632931|Primary|Change From Baseline in QTcF at 1 Hour|Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value.|Baseline and 1 hour|"All patients as treated population in Part 1 of the Study;
22 patients had QTcF data from the vorinostat period (One patient with protocol violation, and two patients without predose measurements were excluded) and 23 patients had QTcF data from the placebo period (one patient with protocol violation and one patient who discontinued were excluded)"||milliseconds||95% Confidence Interval|Mean
760118|NCT00632931|Primary|Change From Baseline in QTcF at 0.5 Hours|The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value.|Baseline and 0.5 hours|"All patients as treated population in Part 1 of the Study;
22 patients had QTcF data from the vorinostat period (One patient with protocol violation, and two patients without predose measurements were excluded) and 23 patients had QTcF data from the placebo period (one patient with protocol violation and one patient who discontinued were excluded)"||milliseconds||95% Confidence Interval|Mean
760119|NCT00632970|Secondary|Change is Plasma Lipids, Lipoproteins and Lipoprotein Subtypes.||24 weeks||||||
760120|NCT00632970|Primary|Absolute Change in CD4 Cell Counts||24 and 48 weeks|||cells/mm^3||Full Range|Mean
760121|NCT00633009|Secondary|The Safety of 15, 30 and 50µg/0.1mL Doses of LtSTA in Healthy Adult Volunteers Who Have Had no Known Previous Exposure to Leishmania Parasites|Local and systemic events following skin test. Local: burning, itching, pain. Systemic: Body aches, dizziness, nausea, weakness.|74 days|||No. of participants with reactions|||Number
760122|NCT00633009|Primary|Sensitizing Effects of LtSTA in Leishmania Naive Adults|Skin test response of subjects in the trial were evaluated 48 hours post injection after each of three skin test given at 30 day intervals in naive individuals (no exposure to the Leishmania organism). (Actual times 0, 30 and 60 days).The outcome measure was designated as number of participants who became sensitized to the Leishmania antigen. This is defined as those participants that had a negative skin test result, followed by a positive response in a subsequent skin test without having been exposed to the Leishmania organism.|62 days|Number of participants completed.||participants|||Number
760123|NCT00633074|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the entire study period (up to Day 21)|The analysis was performed on the Total Vaccinated Cohort including all subjects with the study vaccine administered.||Subjects|||Number
760124|NCT00633074|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs)|Medically Significant Conditions (MSCs) included all unsolicited adverse events that resulted in a medically attended visit.|During a 21-day period after vaccination|The analysis was performed on the Total Vaccinated Cohort including all subjects with the study vaccine administered.||Subjects|||Number
760125|NCT00633074|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During a 21-day period after vaccination|The analysis was performed on the Total Vaccinated Cohort including all subjects with the study vaccine administered.||Subjects|||Number
760126|NCT00633074|Secondary|Duration of Solicited General Symptoms|Duration was expressed as median number of days the symptom persisted. Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever.|During a 7-day period after vaccination|The analysis was performed on the Total Vaccinated Cohort on those subjects who reported the specific symptom.||Days||Full Range|Median
760127|NCT00633074|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any: any symptom regardless of intensity grade; any fever: oral temperature greater than or equal to 38 degrees Celsius (°C). Grade 3: symptoms that prevented normal activity ; Grade 3 fever: oral temperature greater than 39°C. Related: symptom assessed by the investigator as causally related to the study vaccination.|During a 7-day period after vaccination|The analysis was performed on the Total Vaccinated Cohort including all subjects with the study vaccine administered.||Subjects|||Number
760128|NCT00633074|Secondary|Duration of Solicited Local Symptoms|Duration was expressed as median number of days the symptom persisted. Solicited local symptoms assessed include ecchymosis, pain, redness and swelling.|During a 7-day period after vaccination|The analysis was performed on the Total Vaccinated Cohort on those subjects who reported the specific symptom.||Days||Full Range|Median
760146|NCT00633152|Secondary|Clinical Relapse at the Late Follow-up Visit|Evaluate Clinical relapse rate at Late Follow-up (LFU) (21 to 45 days after the final dose of study drug)in those subjects clinically cured at the TOC visit.|Late Follow-up (LFU) Visit (21 to 35 days after end of therapy)||||||
760129|NCT00633074|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed include ecchymosis, pain, redness and swelling. Any: any symptom regardless of intensity grade. Grade 3 pain: considerable pain at rest, which prevented normal everyday activities. Grade 3 ecchymosis, redness and swelling: more than 100 millimeter.|During a 7-day period after vaccination|The analysis was performed on the Total Vaccinated Cohort including all subjects with the study vaccine administered.||Subjects|||Number
760130|NCT00633074|Secondary|Number of Subjects Seroprotected for HI Antibodies Against the Three Vaccine Strains|A seroprotected subject was defined as a suject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.|Days 0 and 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
760131|NCT00633074|Secondary|HI Antibody Seroconversion Factors|Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.|Day 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Fold increase||95% Confidence Interval|Geometric Mean
760132|NCT00633074|Secondary|Number of Subjects Seroconverted for HI Antibodies Against the Three Vaccine Strains|A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a four-fold increase in post-vaccination titer. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.|Day 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
760133|NCT00633074|Secondary|Number of Subjects Seropositive for HI Antibodies Against the Three Vaccine Strains|A seropositive subject was defined as a subject with a serum HI titer greater than or equal to 1:10. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.|Days 0 and 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
760134|NCT00633074|Primary|Serum Haemagglutination-inhibition (HI) Antibody Titer Against the Three Vaccine Strains|Titers were expressed as Geometric Mean Titers (GMTs). The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.|Days 0 and 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Titer||95% Confidence Interval|Geometric Mean
760135|NCT00633087|Secondary|Overall Survival||5 years|The study was closed early due to slow accrual and insufficient data were collected to assess this outcome measure.|||||
760136|NCT00633087|Secondary|Progression-free Survival||5 years|The study was closed early due to slow accrual and insufficient data were collected to assess this outcome measure.|||||
760137|NCT00633087|Secondary|Duration of Response||5 years|The study was closed early due to slow accrual and insufficient data were collected to assess this outcome measure.|||||
760138|NCT00633087|Primary|To Determine the Biochemical Response of This Regimen in Patients With HRPC|A PSA response is defined as a PSA decrease of 50% from baseline maintained for at least 28 days.|5 years|The study was closed early due to slow accrual and insufficient data were collected to assess this outcome measure.|||||
760139|NCT00633126|Secondary|Number of Adverse Events (AEs) Reported After Starting Study Drug Administration (Treatment Emergent Adverse Events, TEAEs) by Relationship to Ceftaroline (Related or Unrelated).|"A TEAE is any untoward medical occurrence a subject experiences following study drug administration.
Subjects were monitored for TEAEs from the start of infusion of ceftaroline fosamil on Study Day 1 through the follow-up contact on Day 7."|Signing of Informed Consent Form (ICF) to last follow up (FU) visit, study day 7 (+-2 days).|"per protocol
Out of 9 participants analyzed, 1 subject did not receive the full dose of study drug."||events|||Number
760140|NCT00633126|Primary|The Maximum Plasma Concentration (Cmax) of Ceftaroline After Administration of Ceftaroline Fosamil at a Dose of 8 mg/kg up to a Maximum Dose of 600 mg Via IV Infusion Over 60 Minutes.|The maximum plasma concentration (Cmax ) occurred around the time of the end of study drug infusion.|12 hours after infusion|per protocol||ng/mL||Standard Deviation|Mean
760141|NCT00633139|Secondary|Change in Cerebrospinal Fluid (CSF) Sulfatide|Changes in CSF sulfatide from baseline to end of study (Week 52). Data mentioned over mean represents the adjusted mean.|Baseline, 52 Weeks|ITT population||%change in CSF sulfatide||95% Confidence Interval|Mean
760142|NCT00633139|Primary|Relative Change in Mullen's Scales of Early Learning|Changes in Mullen's Scales of Early Learning are measured from baseline to end of study (Week 52) using Mullen's Scales of Early Learning. T scores, percentile ranks, and age equivalents can be computed for the four scales separately (visual reception, fine motor, expressive language, and receptive language). Relative change is calculated as percentage change from baseline divided by the age-difference in months between first and last visit. When Mullen's score decreases over time, it indicates the disease worsened over time. Data mentioned over mean represents the adjusted mean.|Baseline, 52 Weeks|ITT population.||Relative % change in Mullen's SOT||95% Confidence Interval|Mean
760143|NCT00633139|Primary|Relative Changes (%) in Gross Motor Function Measurement (GMFM)|Change (percent change) in GMFM is measured from baseline to end of study (Week 52). GMFM is measured using GMFM-88. The GMFM-88 item scores can be summed to calculate a total GMFM-88 score. For each GMFM-88 item, the score is between 0 (minimal) to 3 (maximum). The total GMFM-88 score is between 0 (minimal) to 264 (maximum). Relative changes in GMFM are calculated as percentage change from baseline divided by the age difference in months between first and last visit. The GMFM score decreases over time, which, indicates that the disease worsened over time. Score over time (SOT), data mentioned over mean represents the adjusted mean.|Baseline, 52 Weeks|Intent to Treat (ITT) population included all the participants in the study.||Relative % change in total GMFM-88 SOT||95% Confidence Interval|Mean
786866|NCT00847704|Secondary|Timed 10-Meter Walk|Gait Assessment - Time|Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up|||seconds||Standard Deviation|Mean
760148|NCT00633152|Secondary|The Microbiological Response at the TOC Visit in the mMITT and ME Populations.|Evaluate per-subject the microbiological response at the TOC Visit in the Microbiological Modified Intent-to-treat (mMITT) and Microbiologically Evaluable (ME) populations.|TOC Visit (8 to 15 days after end of therapy)||||||
760149|NCT00633152|Secondary|Clinical Response at the End-of-Therapy (EOT) Visit in the MITT, cMITT and CE Populations.|Evaluate per-subject the clinical response at the End-of-therapy (EOT) Visit in the MITT, cMITT and CE populations.|End-of-therapy (EOT) visit||||||
760150|NCT00633152|Secondary|Clinical Cure Rate at the TOC Visit in the cMITT Population|Evaluate per-subject the clinical response at the Test-of-Cure (TOC) Visit in the Clinical Modified Intent-to-treat (cMITT) Population.|TOC Visit (8 to 15 days after end of therapy)||||||
760151|NCT00633152|Primary|Clinical Response at the Test-of-Cure (TOC) Visit in the Clinically Evaluable (CE) Population|The coprimary efficacy outcome measures were the per-subject clinical cure rate at the TOC Visit in the CE and MITT Populations. Subjects were considered clinically cured at the TOC Visit if they had total resolution of all signs and symptoms of the baseline infection, or improvement of the infection to such an extent that no further antimicrobial therapy was necessary.|Test of Cure Visit (8 to 15 Days after end of therapy)|The Clinically Evaluable (CE) Population included all subjects who satisfied key minimum protocol criteria||percentage of participants||95% Confidence Interval|Number
760152|NCT00633152|Primary|Clinical Response at the Test of Cure (TOC) Visit in the Modified Intent-to-treat (MITT) Population|The coprimary efficacy outcome measures were the per-subject clinical cure rate at the Test of Cure (TOC) Visit in the Clinically Evaluable (CE) and (Modified-Intent-to-Treat) MITT Populations. Subjects were considered clinically cured at the Test of Cure (TOC) Visit if they had total resolution of all signs and symptoms of the baseline infection, or improvement of the infection to such an extent that no further antimicrobial therapy was necessary.|Test of Cure Visit (8 to 15 days after end of therapy)|Modified-Intent-to-Treat (MITT) Population - Any randomized subjects that received any amount of study drug||percentage of participants||95% Confidence Interval|Number
760153|NCT00633217|Secondary|Mean Change From Baseline in Peak Expiratory Flow|The peak expiratory flow is a measure of the amount of air that can be pushed through the airways in a single rapid exhalation. This is measured by a peak flow meter which is a hand held device. Change from baseline was calculated as the average value over Weeks 1-12 minus the baseline value.|Baseline through Week 12|ITT Population. Some participants did not have measured values for peak expiratory flow and were thus not included in the analysis.||Liters/minute (L/min)||Standard Error|Mean
760154|NCT00633217|Secondary|Mean Change From Baseline in AM Pre-dose FEV1|Change from baseline was calculated as the value at Endpoint minus the baseline value. AM pre-dose FEV1, which is assessed using spirometry, is the maximum amount of air you can forcefully exhale in one second prior to taking the morning dose of study drug. Endpoint was defined as the last scheduled observation for AM pre-dose FEV1 during the 12-week treatment period.|Measurement of FEV1 prior to study drug administration; Baseline through Week 12|ITT Population. The numbers analyzed do not match Baseline numbers due to missing data for some participants.||mL||Standard Error|Mean
760155|NCT00633217|Primary|Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) 2 Hours Post-dose of Blinded Study Drug|The primary efficacy analysis was mean change from baseline in 2-hour post-dose FEV1 compared between the two treatment groups at Endpoint. Change from baseline was calculated as the value at Endpoint minus the baseline value. FEV1, which is assessed using spirometry, is the maximal amount of air you can forcefully exhale in one second. Endpoint was defined as the last scheduled observation for 2 hour post-dose FEV1 during the 12-week treatment period.|2 hours after administration of blinded study drug; Baseline through Week 12|Intent-to-Treat (ITT) Population: all participants who had been randomized to study drug. The numbers analyzed do not match Baseline numbers due to missing data for some participants.||milliliters (mL)||Standard Error|Mean
760156|NCT00633243|Primary|Number of Participants With a Sustained Virologic Response (SVR)|SVR is defined as continued undetectable HCV viral load at 24 weeks|24 weeks (end of treatment)|All subjects in mDOT arm and SAT arm who completed treatment.||participants|||Number
760157|NCT00633256|Secondary|Urinary Cotinine Level|Urinary Cotinine level at the 4-week follow up timepoint|4 Week Follow-up Timepoint|Subjects used for analysis are those who reached the 4 week followup timepoint.||Mean ng/ml||Standard Deviation|Mean
760158|NCT00633256|Secondary|Cigarettes Smoked Per Day|The number of cigarettes smoked per day at the 4-week follow up timepoint.|4 Week Followup|The number of subjects in the study at the 4-week timepoint.||Cigarettes per day||Standard Deviation|Mean
760159|NCT00633256|Primary|Cigarettes Smoked Per Day|The number of cigarettes smoked per day at the 1 week follow up time point.|1 week follow-up|The number of participants used for analysis were those who completed the 4-week follow-up timepoint.||Cigarettes per day||Standard Deviation|Mean
760160|NCT00633360|Secondary|Percent Change in Daily Record of Severity of Problems (DRSP)|The DRSP is a 24-item self-administered daily dairy that assesses the severity of mood and physical symptoms which occur as part of the premenstrual syndrome and PMDD. Each question is rated on a scale of 1-6 with a total score range from 24-144. A higher score indicates greater symptom burden.|Baseline and 2 months|||percent change||Inter-Quartile Range|Median
760161|NCT00633360|Primary|Percent Change in Luteal Montgomery-Asberg Depression Rating Scale (MADRS)|The Montgomery-Åsberg Depression Rating Scale is a widely used 10-item clinician-rated scale that describes the severity of depressive symptoms. It has a range of 0-60 with higher scores indicating greater symptom burden. Participants were assessed at baseline and during 2nd treatment month in order to calculate the change in MADRS score.|Baseline and 2 months|||percent change||Inter-Quartile Range|Median
760162|NCT00633399|Secondary|Comparing Scores on HAM-D 17 Baseline Visit to Phase 2 Final Visit at Week 8|This will involve looking at the change in HAM-D 17 scores during phase 2. For HAMD-17 the minimum is 0, the maximum is 52, and greater scores represent more symptoms.|8 weeks|||units on a scale||Standard Deviation|Mean
760163|NCT00633399|Secondary|Remission Rates (HAM-D 17 Scores of Less Than 8) After Treatment Phase 2.|A secondary outcome measure will be remission rates (HAM-D 17 scores of less than 8) after treatment phase 2.. A remitted will be a patient with a final score of 7 or less on the HAMD-17 during phase 2.|8 weeks|||Percentage of patients|||Number
760164|NCT00633399|Primary|The Primary Outcome Measure Will be Response Rates (50% Decrease in HAM-D-17 Scores) During Phase 2|The primary outcome measure will be response rates (50% decrease in HAM-D-17 scores) during phase 2. A responder will be a patient who experiences a 50% or greater decrease in symptoms according to the HAM-D-17 during phase 2.|8 Weeks|||Percentage of patients|||Number
760165|NCT00633464|Secondary|Number of Participants With Serum Chemistry Abnormalities|Grading: NCI CTCAE, Version 3.0. GR1=mild, GR2=moderate, GR3=severe, GR4=life threatening or disabling. Normal ranges provided by local laboratory and may also vary by age and sex. Alanine aminotransferase, aspartate aminotransferase, and alkaline phosphatase: GR1=>ULN–2.5*ULN (upper limit of normal); GR2=>2.5–5.0*ULN; GR3=>5.0-20.0*ULN; GR4:>20.0*ULN. Total bilirubin:GR1=>ULN–1.5*ULN, GR2=>1.5–3.0*ULN, GR3=>3-10*ULN, GR4=>10*ULN. Creatinine: GR1=>ULN–1.5*ULN, GR2=>1.5–3.0*ULN, GR3=>3.0–6.0*ULN, GR4=>6.0*ULN.|Assessed prior to 1st cycle, at beginning of each cycle, weekly (cetuximab treatment), and every 4 weeks within 30 days after last dose of study drug. Median time on ixapebilone therapy: 15 weeks (range:3-54:ixabepilone arm;3-36:ixapebilone+cetuximab arm)|Treated participants: Participants who received any treatment (ixabepilone or cetuximab). n=number of participants with measures available at the time.||participants|||Number
760166|NCT00633464|Primary|Number of Participants With Best Overall Response as Assessed With Response Criteria in Solid Tumors (RECIST)|PD = At least a 20% increase in the sum of LD of target lesions in reference to the smallest sum LD recorded at or following baseline or unequivocal progression of existing non-target lesion(s) overall; Stable Disease (SD) = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (LD) of all target lesions.|Assessed at 6 week intervals for first 12 months from randomization, thereafter every 3 months (to a maximum follow-up for tumor response of 17 months).|All randomized participants.||participants|||Number
760167|NCT00633464|Secondary|Number of Participants With Hematology Abnormalities|Grading: NCI CTCAE, Version 3.0. GR1=mild, GR2=moderate, GR3=severe, GR4=life threatening or disabling. Normal ranges provided by local laboratory and may also vary by age and sex. Hemoglobin:GR1=<LLN–10.0g/dL; GR2=<10.0–8.0g/dL; GR3:<8.0–6.5g/dL, GR4:<6.5g/dL. Platelets:GR1=<LLN–75.0*10^9/L; GR2=<75.0–50.0*10^9/L; GR3:<50.0–25.0*10^9/L, GR4:<25.0*10^9/L. Absolute Neutrophil Count (ANC):GR1=<LLN–1.5*10^9 /L; GR2=<1.5–1.0*10^9/L; GR3:<1.0–0.5*10^9/L; GR4:<0.5*10^9/L. White blood cell (WBC):GR1=<LLN–3.0*10^9/L; GR2=<3.0–2.0*10^9/L; GR3:<2.0–1.0*10^9/L; GR4:<1.0*10^9/L. LLN=lower limit of normal.|Assessed prior to 1st cycle, at beginning of each cycle, weekly (cetuximab treatment), and every 4 weeks within 30 days after last dose of study drug. Median time on ixapebilone therapy: 15 weeks (range:3-54:ixabepilone arm;3-36:ixapebilone+cetuximab arm)|Treated participants: Participants who received any treatment (ixabepilone or cetuximab). n=number of participants with measures available at the time.||participants|||Number
760168|NCT00633464|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs), and AEs Leading to Discontinuation of Study Therapy Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0|AE: New untoward medical occurrence or worsening of a preexisting medical condition that does not have causal relationship with this treatment. SAE: Untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, drug dependency/abuse; life-threatening, an important medical event, a congenital anomaly/birth defect; requires inpatient hospitalization/prolongs existing hospitalization. Grade (GR) 3=Severe; and GR4=Life-threatening or disabling. Other reasons for death included hepatic failure and respiratory distress.|Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 15 weeks (range: 3-54 weeks for ixabepilone arm; 3-36 weeks for ixabepilone+cetuximab arm)|All treated participants: Participants who received any treatment (ixabepilone or cetuximab).||participants|||Number
760169|NCT00633464|Secondary|Duration of Response|Defined as period from the time that measurement criteria are first met for CR or PR until first date of documented PD or death. Estimated using the Kaplan-Meier product-limit method; CI was computed using Brookmeyer and Crowley method. CR: Disappearance of all target and non-target lesions. PR: At least 30% reduction from baseline in the sum of LD of all target lesions with reference to baseline sum LD. PD: At least 20% increase in sum of LD of target lesions in reference to smallest sum LD recorded at or following baseline or unequivocal progression of existing non-target lesion(s) overall.|From the date of first PR or CR assessment to date of progression, death, or last tumor assessment (maximum participant duration of response of 15.6 months)|Randomized participants with response of CR or PR. Participants who did not relapse or die were censored on the date of their last tumor assessment.||months||95% Confidence Interval|Median
760170|NCT00633464|Primary|Percentage of Participants With Objective Response (OR; Using Response Evaluation Criteria in Solid Tumors [RECIST])|The participant had an OR if her best overall response (BOR) during the study was either a complete response (CR) or a partial response (PR) according to the RECIST as determined by the investigator. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (LD) of all target lesions. Confidence interval (CI) was Computed using Clopper-Pearson method.|Assessed every 6 weeks for first 12 months from randomization thereafter every 3 months until disease progression (maximum participant objective response of 18.3 weeks)|All randomized participants.||percentage of participants||95% Confidence Interval|Number
760171|NCT00633464|Secondary|Time to Response|"Time to response is defined as the time from the date of start of treatment until measurement criteria are first met for PR or CR (whichever is recorded first).
CR: Disappearance of all target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the LD of all target lesions with reference to the baseline sum LD.
Time to response was estimated using the Kaplan-Meier product-limit method."|Assessed every 6 weeks for first 12 months from randomization thereafter every 3 months until CR or PR (maximum participant time to response of 18.3 weeks.)|Randomized participants with response of CR or PR.||weeks||Full Range|Median
760201|NCT00633880|Secondary|Change in Systolic Blood Pressure (SBP) Measurements 3 Minutes Post Standing;|Change: standing systolic blood pressure at end of study minus standing systolic blood pressure at randomization. In this withdrawal design, a negative score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug) .|14 days|three placebo patients excluded from the analysis due to missing standing blood pressure values at either randomization or end of study.||mmHg||Standard Deviation|Mean
760172|NCT00633464|Secondary|Progression Free Survival (PFS)|"PFS is defined as the time interval from date of randomization until the first date of documented progressive disease (PD) or death from any cause without prior documentation of progression. The PFS was estimated using the Kaplan-Meier product-limit method, and a two-sided 95% CI for the median PFS time was computed using the method of Brookmeyer and Crowley.
PD: At least 20% increase in sum of LD of target lesions in reference to smallest sum LD recorded at or following baseline or unequivocal progression of existing non-target lesion(s) overall."|From the date of randomization to date of progression, death, or last tumor assessment (maximum participant PFS of 17 months)|All randomized participants. Participants who did not progress or die were censored on the date of their last tumor assessment.||months||95% Confidence Interval|Median
760173|NCT00633477|Secondary|Ventilator Free Days.|Number days participant was not on Ventilattor support.|Day 28|This study was terminated early when 17 subjects had received treatment.||Days|||Number
760174|NCT00633477|Secondary|Vasopressor Free Days.|Number days participant did not need vasopressors.|Day 28|This study was terminated early when 17 subjects had received treatment.||days|||Number
760175|NCT00633477|Secondary|ICU Free Days|Number days participant was not in ICU|Day 28|This study was terminated early when 17 subjects had received treatment.||days|||Number
760176|NCT00633477|Primary|All-cause Mortality|Mortality regardless of cause at Day 28|Day 28|Participants who received study drug||Percent of Participant|||Number
760177|NCT00633477|Primary|All-cause Mortality|Mortality regardless of cause at Day 28|Day 28|Participants who received study drug.||Participants|||Number
760178|NCT00633594|Secondary|Overall Survival of Previously Treated and Previously Untreated Participants|"Defined as the date of study entry to the date of death.
Overall Survival will be examined using time-to-event analysis methods. Kaplan-Meier figures will be generated and the log-rank test will be used to examine differences existing between various levels of stratification"|Every 3 months (+/- 2 weeks) after discontinuation of study treatment for 2 years, then every 6 months after documented disease progression|all participants that received study treatment||months||95% Confidence Interval|Median
760179|NCT00633594|Secondary|Overall Survival of Phase I and Phase II Participants|"Defined as the date of study entry to the date of death.
Overall Survival will be examined using time-to-event analysis methods. Kaplan-Meier figures will be generated and the log-rank test will be used to examine differences existing between various levels of stratification"|Every 3 months (+/- 2 weeks) after discontinuation of study treatment for 2 years, then every 6 months after documented disease progression|all participants that received study treatment||months||95% Confidence Interval|Median
760180|NCT00633594|Secondary|Progression Free Survival (PFS) of Previously Treated and Previously Untreated Participants|"Defined as the time from entry onto study until lymphoma progression or death from any cause.
Progression Free Survival will be examined using time-to-event analysis methods. Kaplan-Meier figures will be generated and the log-rank test will be used to examine differences existing between various levels of stratification."|Every 3 months (+/- 2 weeks) after discontinuation of study treatment for 2 years, then every 6 months after documented disease progression|All participants that received study treatment||months||95% Confidence Interval|Median
760181|NCT00633594|Secondary|Progression Free Survival (PFS) of Phase I and Phase II Participants|"Defined as the time from entry onto study until lymphoma progression or death from any cause.
Progression Free Survival will be examined using time-to-event analysis methods. Kaplan-Meier figures will be generated and the log-rank test will be used to examine differences existing between various levels of stratification."|Every 3 months (+/- 2 weeks) after discontinuation of study treatment for 2 years, then every 6 months after documented disease progression|All participants that received study treatment||months||95% Confidence Interval|Median
760182|NCT00633594|Secondary|Duration of Response (DoR) of Previously Treated and Previously Untreated Participants|Measured from the documented beginning of response (CR or PR) to the time of relapse. This is measured in responders per Non-Hodgkin's Lymphoma Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007.) CR: complete disappearance of detectable clinical evidence of disease and disease-related symptoms; PR: 50% or greater decrease in sum of product of diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase in size of other nodes, liver or spleen, no new disease sites, patients with CR and persistent morphologic bone marrow involvement.|Every 3 months (+/- 2 weeks) after discontinuation of study treatment for 2 years or until documented disease progression|All participants that received study treatment that were responders (achieved a PR or better)||months||95% Confidence Interval|Median
760183|NCT00633594|Secondary|Duration of Response (DoR) of Phase I and Phase II Participants|"Measured from the documented beginning of response (CR or PR) to the time of relapse. This is measured in responders per Non-Hodgkin's Lymphoma Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007.) CR: complete disappearance of detectable clinical evidence of disease and disease-related symptoms; PR: 50% or greater decrease in sum of product of diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase in size of other nodes, liver or spleen, no new disease sites, patients with CR and persistent morphologic bone marrow involvement.
Duration of Response will be examined using time-to-event analysis methods. Kaplan-Meier figures will be generated and the log-rank test will be used to examine differences existing between various levels of stratification."|Every 3 months (+/- 2 weeks) after discontinuation of study treatment for 2 years or until documented disease progression|All participants that received study treatment that were responders (achieved a PR or better)||months||95% Confidence Interval|Median
760184|NCT00633594|Secondary|Time to Best Response of Previously Treated and Previously Untreated Participants|Measured from the time of study entry to the documented beginning of response (CR or PR). This is measured in responders per Non-Hodgkin's Lymphoma Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007.) CR: complete disappearance of detectable clinical evidence of disease and disease-related symptoms; PR: 50% or greater decrease in sum of product of diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase in size of other nodes, liver or spleen, no new disease sites, patients with CR and persistent morphologic bone marrow involvement.|Every 3 months (+/- 2 weeks) after discontinuation of study treatment for 2 years|All patients that received study treatment that were evaluable for a response assessment (2 previously untreated participants and 1 previously treated participant were considered unevaluable, discontinuing prior to first post-baseline response assessment)||months||95% Confidence Interval|Median
787336|NCT00849875|Primary|Anti-MAGE-A3 Antibody Concentrations (CMI)|Analysis of MAGE-A3 cellular response was not performed and data were not collected..|Post Dose 4 at Week 13 (W13).||||||
760185|NCT00633594|Secondary|Time to Best Response of Phase I and Phase II Participants|"Measured from the time of study entry to the documented beginning of response (CR or PR). This is measured in responders per Non-Hodgkin's Lymphoma Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007.) CR: complete disappearance of detectable clinical evidence of disease and disease-related symptoms; PR: 50% or greater decrease in sum of product of diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase in size of other nodes, liver or spleen, no new disease sites, patients with CR and persistent morphologic bone marrow involvement.
Time to Best Response will be examined using time-to-event analysis methods. Kaplan-Meier figures will be generated and the log-rank test will be used to examine differences existing between various levels of stratification."|Every 3 months (+/- 2 weeks) after discontinuation of study treatment for 2 years|All participants that received study treatment that were evaluable for a response assessment (one participant in Phase I and two participants in Phase II were considered unevaluable, discontinuing prior to first post-baseline response assessment)||days||Full Range|Median
760186|NCT00633594|Secondary|Overall Response Rate (ORR) of Previously Treated and Previously Untreated Participants|Response to treatment (Complete Response (CR) or Partial Response (PR)) determined using Non-Hodgkin's Lymphoma Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007.) CR: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms; PR: 50% or greater decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or extranodal masses, no increase in the size of other nodes, liver or spleen, no new sites of disease, patients who achieve CR but have persistent morphologic bone marrow involvement; Stable Disease (SD): failing to attain PR or CR, but not fulfilling criteria for progressive disease; Progressive Disease (PD)/Relapse: appearance of new lesions more than 1.5 cm in any axis, 50% or greater increase from nadir SPD of any previously involved sites, 50% or greater increase in the longest diameter of any single previously identified node or extranodal mass more than 1 cm in short axis.|Every 6 weeks until treatment discontinuation then every 3 months thereafter, projected average 24 months|The efficacy evaluable population (all participants who have received any study treatment)||Participants|||Count of Participants
760187|NCT00633594|Secondary|Overall Response Rate (ORR) of Phase I and Phase II Participants|Response to treatment (Complete Response (CR) or Partial Response (PR)) determined using Non-Hodgkin's Lymphoma Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007.) CR: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms; PR: 50% or greater decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or extranodal masses, no increase in the size of other nodes, liver or spleen, no new sites of disease, patients who achieve CR but have persistent morphologic bone marrow involvement; Stable Disease (SD): failing to attain PR or CR, but not fulfilling criteria for progressive disease; Progressive Disease (PD)/Relapse: appearance of new lesions more than 1.5 cm in any axis, 50% or greater increase from nadir SPD of any previously involved sites, 50% or greater increase in the longest diameter of any single previously identified node or extranodal mass more than 1 cm in short axis.|Every 6 weeks until treatment discontinuation then every 3 months thereafter, projected average 24 months|The efficacy evaluable population (all participants who have received any study treatment)||Participants|||Count of Participants
760188|NCT00633594|Primary|Incidence of Non-Serious Adverse Events as a Measure of Safety and Tolerability, Phase II|"A count of affected participants with non-serious adverse events (regardless of relationship to study treatments) occurring in >= 15% of treated patients enrolled in the Phase II section of the study.
Lenalidomide DL-1 dose (10 mg orally, once daily (PO QD)) Day 1-14 followed by 7 days of rest, Rituximab 375 mg/m2 IV Days 1, 8, and 15 of Cycle 1; Cycles 2-6: 375 mg/m2 IV Day 1, Bortezomib 1.3 mg/m2 subcutaneous Days 1, 4, 8, and 11 for Cycles 1-6"|Collected from day of first dose to 30 days after the last dose of study medication, a maximum of 18 weeks and 30 days after last study treatment|Includes patients that were enrolled in the Phase II section of the study||participants|||Number
760189|NCT00633594|Primary|Maximum Tolerated Dose of Lenalidomide Combined With Bortezomib and Rituximab in Phase I Participants|"Determination of the maximum tolerated dose (MTD) of lenalidomide combined with bortezomib and rituximab, defined as the highest dose at which ≤1 of 6 patients experiences a dose-limiting toxicity according to the NCI CTCAE v. 4.03.
MTD of Lenalidomide was tested, included with 1.3 mg/m2 subcutaneous (D1, 4, 8, 11) bortezomib, 375 mg/m2 (D1, 8, 15 of Cycle 1, D1 on subsequent cycles) rituximab.
Three dose limiting toxicities were reported in two patients (grade 4 neutropenia and grade 3 neuropathy, grade 3 rash)"|Collected from day of first dose to the end of the first treatment cycle, up to 21 days|Includes patients that were enrolled in both lenalidomide dose levels (10 mg PO daily, 15 mg PO daily) in the Phase I portion of the study||mg lenalidomide, orally, daily, day 1-14|||Number
760190|NCT00633750|Secondary|Average Post-treatment Plasma Level of Erlotinib Hydrochloride|Post-treatment plasma level in µmol/L of erlotinib hydrochloride|After last dose of Tarceva, at 5-14 days, and before surgery|Participants with blood taken within 24 hours of last dose of erlotinib and before surgery||µmol/L||Standard Deviation|Mean
760191|NCT00633750|Secondary|Molecular Profile of Participants Who Are Responsive to Tarceva|Determined by estrogen receptor status (ER) and human epidermal growth factor receptor 2 (HER2) status, which are measured by staining of 200-500 tumor cells and noting the number stained. Positive = > 10% of cell show staining, negative = < 10% of cells show staining|at 5-14 days|Participants with available pre- and post-treatment tissue and who demonstrated a post-treatment decrease in Ki67 levels compared to their pre-treatment levels||participants|||Number
760192|NCT00633750|Primary|Number of Participants Experiencing in Situ Anti-tumor Effect of Tarceva|In situ anti-tumor effect of Tarceva as measured by a minimum 75% reduction in Ki67 compared to pre-treatment tumor cells in patients with operable breast cancer.|5-14 days|Patients who received the study drug and who had available pre- and post-treatment tissue.||participants|||Number
760193|NCT00633867|Primary|Intubation Time|Time from anaesthetist picking up laryngoscope until 1st upward capnograph deflection after intubation|At intubation|||seconds||Inter-Quartile Range|Median
760194|NCT00633867|Secondary|Incidence of Visible Trauma to the Airway||At analysis||||||
760195|NCT00633867|Secondary|Incidence of Low Arterial Saturation During Intubation||At analysis||||||
760196|NCT00633867|Secondary|Number of Intubations Taking More Than 70 Seconds||At Analysis||||||
760197|NCT00633867|Secondary|Incidence of Initial Oesophageal Intubation||At analysis||||||
760198|NCT00633867|Secondary|Number of Attempts to Secure Successful Intubation|Is there a difference in the number of attempts required to secure successful intubation ?|At analysis||||||
760202|NCT00633880|Secondary|Change in Orthostatic Hypotension Symptom Scores Excluding Dizziness (OHSA Composite Items 2-6)|OHSA composite scale (items 2-6) is the average of five OHSA items: 2) Problems with vision; 3) Weakness; 4) Fatigue; 5) Trouble concentrating; and 6) Head/neck discomfort. Each asks the patient to rate their symptoms over the past week. Each item is scored on a Likert scale from 0 to 10, with 10 being the most severe. Change: score at end of study minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug) .|14 days|"One placebo patient excluded from analysis per the SAP because all baseline values in the composite were zero.
LOCF was used to impute values for patients who did not have an end of study visit."||units on a scale||Standard Deviation|Mean
760203|NCT00633880|Secondary|Change in Orthostatic Hypotension Symptom Assessment Score (OHSA Composite)|The OHSA scale is the average of six items: 1) Dizziness, lightheadedness, feeling faint or feeling like you might black out; 2) Problems with vision; 3) Weakness; 4) Fatigue; 5) Trouble concentrating; and 6) Head/neck discomfort. Each asks the patient to rate their symptoms over the past week. Each item is scored on a Likert scale from 0 to 10, with 10 being the most severe. Change: score at end of study minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug) .|14 days|||units on a scale||Standard Deviation|Mean
760204|NCT00633880|Secondary|Change in Ability to Conduct Activities of Daily Living Score (OHDAS Composite Score)|The OHDAS scale is the average of four items: 1) Standing for a short time; 2) Standing for a long time; 3) Walking for a short time; and 4) Walking for a long time. Each asks the patient to rate their disease impact over the past week. Each item is scored on a Likert scale from 0 to 10, with 10 being the most severe. Change: score at end of study minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug) .|14 days|One placebo patient excluded from analysis because OHDAS values were not evaluable.||units on a scale||Standard Deviation|Mean
760205|NCT00633880|Secondary|Change in Head/Neck Discomfort (OHSA Item 6)|OHSA item 6 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug) .|14 days|||units on a scale||Standard Deviation|Mean
760206|NCT00633880|Post-Hoc|Change in Orthostatic Hypotension Questionnaire Score (OHQ)|"The OHQ is the average of two sub-scales, the Orthostatic Hypotension Symptom Assessment Scale (OHSA) and the Orthostatic Hypotension Daily Activities Scale (OHDAS). Each asks the patient to rate their symptoms or disease impact over the past week. The OHSA sub-scale is the average of six items: 1) Dizziness, lightheadedness, feeling faint or feeling like you might black out; 2) Problems with vision; 3) Weakness; 4) Fatigue; 5) Trouble concentrating; and 6) Head/neck discomfort. The OHDAS sub-scale is the average of four items: 1) Standing for a short time; 2) Standing for a long time; 3) Walking for a short time; and 4) Walking for a long time. Each item is scored on a Likert scale from 0 to 10, with 10 being the most severe.
In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug) ."|14 days|3 droxidopa patients and 2 placebo patients were excluded from the analysis due to missing randomization values.||units on a scale||Standard Deviation|Mean
760207|NCT00633880|Secondary|Change in Concentration (OHSA Item 5)|OHSA item 5 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug) .|14 days|||units on a scale||Standard Deviation|Mean
760208|NCT00633880|Secondary|Change in Vision (OHSA Item 2)|OHSA item 2 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug) .|14 days|||units on a scale||Standard Deviation|Mean
760209|NCT00633880|Secondary|Change in Weakness (OHSA Item 3)|OHSA item 3 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug) .|14 days|||units on a scale||Standard Deviation|Mean
760210|NCT00633880|Secondary|Change in Fatigue (OHSA Item 4)|OHSA item 4 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug) .|14 days|||units on a scale||Standard Deviation|Mean
760211|NCT00633880|Primary|Change in Dizziness/ Lightheadedness/ Feeling Faint/ or Feeling Like You Might Blackout (OHSA Item 1)|OHSA item 1 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug) .|14 days|Missing data were imputed using the last observation carry forward method.||units on a scale||Standard Deviation|Mean
760212|NCT00633893|Secondary|Adjudicated All-Cause Death During the Intended Treatment Period - Randomized Population Without Imputation|DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. New/recurrent VTE, death, venous/arterial thromboembolic events, bleeding, thrombocytopenia, acute myocardial infarction and stroke were also adjudicated. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for this endpoint; participants who had an event during the intended treatment period were counted.|Day 1 up to 12 Months|Intent to treat: all randomized participants with valid consent. Participants analyzed per randomized treatment assigned. (n) number of events = 7, 4, 14 in apixaban 2.5 mg, 5 mg, and placebo arms, respectively. CI for single event rate was calculated based on the Wald asymptotic confidence limits.||Proportion of participants||95% Confidence Interval|Number
760213|NCT00633893|Secondary|Adjudicated Cardio Vascular (CV)-Related Death During the Intended Treatment Period - Randomized Population Without Imputation|CV-related death was defined as myocardial infarction, stroke, or other specified cardiovascular event and these were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for this endpoint; participants who had an event during the intended treatment period were counted.|Day 1 up to 12 Months|Intent to treat: all randomized participants with valid consent. Participants analyzed per randomized treatment assigned. (n) number of events = 2, 3, 10 in apixaban 2.5 mg, 5 mg, and placebo arms, respectively. CI for single event rate was calculated based on the Wald asymptotic confidence limits.||Proportion of participants||95% Confidence Interval|Number
760214|NCT00633893|Secondary|Adjudicated Venous Thromboembolism (VTE)- Related Death During the Intended Treatment Period - Randomized Population Without Imputation|VTE related death defined as PE (based on objective diagnostic testing, autopsy), unexplained death (and VTE cannot be ruled out), sudden death (and VTE cannot be ruled out). DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. New/recurrent VTE, and death, were also adjudicated. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for this endpoint.|Day 1 up to 12 Months|Intent to treat: all randomized participants with valid consent. Participants analyzed per randomized treatment assigned. (n) number of events = 2, 3, 7 in apixaban 2.5 mg, 5 mg, and placebo arms, respectively. CI for single event rate was calculated based on the Wald asymptotic confidence limits.||Proportion of participants||95% Confidence Interval|Number
760215|NCT00633893|Secondary|Adjudicated Nonfatal Pulmonary Embolism (PE) During the Intended Treatment Period - Randomized Population Without Imputation|PE was adjudicated/confirmed by a central independent adjudication committee blinded to treatment: PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for this endpoint; participants who had an event during the intended treatment period were counted.|Day 1 up to 12 Months|Intent to treat: all randomized participants with valid consent. Participants analyzed per randomized treatment assigned. (n) number of events = 8, 4, 15 in apixaban 2.5 mg, 5 mg, and placebo arms, respectively. CI for single event rate was calculated based on the Wald asymptotic confidence limits.||Proportion of participants||95% Confidence Interval|Number
760216|NCT00633893|Secondary|Adjudicated Nonfatal Deep Vein Thrombosis (DVT) During the Intended Treatment Period - Randomized Population Without Imputation|DVT was adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for this endpoint; participants who had an event during the intended treatment period were counted.|Day 1 up to 12 Months|Intent to treat: all randomized participants with valid consent. Participants analyzed per randomized treatment assigned. (n) number of events = 6, 8, 53 in apixaban 2.5 mg, 5 mg, and placebo arms, respectively. CI for single event rate was calculated based on the Wald asymptotic confidence limits.||proportion of participants||95% Confidence Interval|Number
760217|NCT00633893|Secondary|Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or Cardio Vascular (CV) - Related Death During the Intended Treatment Period - Randomized Population Without Imputation|CV-related death was defined as myocardial infarction, stroke, or other specified cardiovascular event. Index events of DVT and/or PE, along with myocardial infarction and stroke were adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for these endpoints; participants who had an event during the intended treatment period were counted.|Day 1 up to 12 Months|Intent to treat: all randomized participants with valid consent. Participants analyzed per randomized treatment assigned. (n) number of events = 14, 14, 76 in apixaban 2.5 mg, 5 mg, and placebo arms, respectively. CI for single event rate was calculated based on the Wald asymptotic confidence limits.||proportion of participants||95% Confidence Interval|Number
760236|NCT00633919|Secondary|Global Evaluation of Efficacy by Subject at the End of The Evaluation Period in 2008|"The treatment efficacy was rated by subjects at the end of the evaluation period in autumn 2008. Subjects rated their asthma symptoms in comparison to previous autumn using the categories: “much worse”, “worse”, “the same”, “better”, or “much better”.
The categories “much better” or “better” were grouped as “improved”. The categories “the same”, “worse” or “much worse” were grouped as “not improved”."|8 weeks|All analyses were on all randomised participants (full analysis set) with data in 2008: All available data were used to their full extent, but no imputation of data was performed.||Participants|||Number
760331|NCT00625391|Primary|Change From Baseline (100%) in Ratio of Bone Formation Marker to Bone Resorption Marker|Bone formation biomarker: bone-specific alkaline phosphatase (BAP) Bone resorption biomarker: tartrate-resistant acid phosphatase (TRAP)|24 weeks|Analyzed on those who completed the study. Percent change relative to the baseline for each group.||percentage change from baseline||Standard Deviation|Mean
760218|NCT00633893|Secondary|Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or Venous Thromboembolism-related Death During the Intended Treatment Period - Randomized Population Without Imputation|VTE related death defined as PE (based on objective diagnostic testing, autopsy), unexplained death (and VTE cannot be ruled out), sudden death (and VTE cannot be ruled out). DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. New/recurrent VTE and death, were also adjudicated. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for these endpoints.|Day 1 up to 12 Months|Intent to treat: all randomized participants with valid consent. Participants analyzed per randomized treatment assigned. (n) number of events = 14, 14, 73 in apixaban 2.5 mg, 5 mg, and placebo arms, respectively. CI for single event rate was calculated based on the Wald asymptotic confidence limits.||proportion of participants||95% Confidence Interval|Number
760219|NCT00633893|Secondary|Adjudicated Total Bleeding During the Treatment Period - Treated Participants|All bleeding events were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. Total bleeding was defined as any major, clinically relevant non-major, or minor bleeding. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). CI for single event rate was calculated based on the Wald asymptotic confidence limits. Treated population includes randomized participants who received at least one dose of study drug.|Day 1 up to 12 months|Treated population includes randomized participants who received at least one dose of study drug. (n) number of events = 94, 121, 74 in apixaban 2.5 mg, 5 mg, and placebo arms, respectively.||Proportion of participants||95% Confidence Interval|Number
760220|NCT00633893|Secondary|Adjudicated Clinically Relevant Minor Bleeding During the Treatment Period - Treated Participants|All bleeding events were reviewed by the central independent adjudication committee blinded to treatment and classified as major bleeding, clinically relevant non-major bleeding, minor bleeding or no bleeding. If event was not major or clinically relevant non-major, it was judged to be minor. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Confidence interval (CI) for single event rate was calculated based on the Wald asymptotic confidence limits. Treated population includes randomized participants who received at least one dose of study drug.|Day 1 up to 12 months|Treated population includes randomized participants who received at least one dose of study drug. (n)number of events = 75, 98, 58 in apixaban 2.5 mg, 5 mg, and placebo arms, respectively.||Proportion of participants||95% Confidence Interval|Number
760221|NCT00633893|Secondary|Adjudicated Clinically Relevant Non-major Bleeding During the Treatment Period - Treated Participants|Non-major clinically relevant bleeding was adjudicated/confirmed by a central independent adjudication committee blinded to treatment and defined as: acute clinically overt bleeding compromising hemodynamics; leading to hospitalization; traumatic subcutaneous hematoma; intramuscular hematoma; epistaxis that lasted for more than 5 minutes, was repetitive or led to an intervention; spontaneous gingival bleeding (or lasting more than 5 minutes); spontaneous hematuria (macroscopic or lasted more than 24 hours after instrumentation of the urogenital tract); macroscopic gastrointestinal hemorrhage (including at least 1 episode of melena or hematemesis (if clinically apparent with positive results on a fecal occult-blood test); rectal blood loss. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). CI for single event rate was calculated based on the Wald asymptotic confidence limits.|Day 1 up to 12 months|Treated population includes randomized participants who received at least one dose of study drug. (n)number of events = 25, 34, 19 in apixaban 2.5 mg, 5 mg, and placebo arms, respectively.||Proportion of participants||95% Confidence Interval|Number
760222|NCT00633893|Secondary|Adjudicated Composite of Major/Clinically Relevant Non-major Bleeding During the Treatment Period - Treated Participants|Major bleeding and clinically relevant non-major bleeding were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. Major bleeding was defined as acute clinically overt bleeding: associated with a fall in hemoglobin of 2 g/dL or more, or leading to a transfusion of 2 or more units of packed red blood cells or 1000 mL or more of whole blood, or in a critical site: intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal, or another critical organ or is fatal. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). CI for single event rate was calculated based on the Wald asymptotic confidence limits. Treated population includes randomized participants who received at least one dose of study drug.|Day 1 up to 12 Months|Treated participants were those who received at least 1 dose of study drug. (n)number of events = 27, 35, 22 in apixaban 2.5 mg, 5 mg, and placebo arms, respectively.||proportion of participants||95% Confidence Interval|Number
760223|NCT00633893|Secondary|Adjudicated Major Bleeding During the Treatment Period - Treated Population|Major bleeding was adjudicated/confirmed by a central independent adjudication committee blinded to treatment and was defined as acute clinically overt bleeding: associated with a fall in hemoglobin of 2 grams per deciliter (g/dL) or more, or leading to a transfusion of 2 or more units of packed red blood cells or 1000 milliliters (mL) or more of whole blood, or in a critical site: intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal, or another critical organ; or is fatal. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Confidence interval (CI) for event rate was calculated based on the Wald asymptotic confidence limits. Treated population includes randomized participants who received at least one dose of study drug.|Day 1 up to 12 Months|Treated population includes randomized participants who received at least one dose of study drug. (n) number of events = 2, 1, 4 in apixaban 2.5 mg, and 5 mg, and placebo arms, respectively.||Proportion of participants||95% Confidence Interval|Number
760249|NCT00634049|Secondary|All-cause Mortality Through Day 42 and Day 84|"All-cause Mortality was assessed through Day 42 and Day 84 and summarized for ITT population
End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days."|Baseline to End of Treatment (EOT [Day 180])|Intent-To-Treat population (ITT)||percentage of participants|||Number
760224|NCT00633893|Secondary|Number of Participants With an Adjudicated Symptomatic Nonfatal Venous Thromboembolism (VTE) Recurrence or Death (All Cause) During the Intended Treatment Period - Randomized Participants Without Imputation|All index events, DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. First event category was the first primary event for each participant and each participant was counted once. CV-related death was presented excluding VTE-related death. In participants with event category, each participant was counted once in each event category but could have been counted in multiple categories. No imputation was done for these endpoints; participants who had an event during the intended treatment period were counted.|Day 1 up to 12 Months|Intent to treat: all randomized participants with valid consent. Analyzed per randomized treatment assigned. In first event (first primary event) each participant counted once. In event category, each participant was counted only once in each event category but could have been counted in multiple categories.||participants|||Number
760225|NCT00633893|Secondary|Adjudicated All-Cause Death During the Intended Treatment Period - Randomized Population With Imputation|DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. New/recurrent VTE, death, venous/arterial thromboembolic events, bleeding, thrombocytopenia, acute myocardial infarction and stroke were also adjudicated. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Participants with missing endpoint information were classified as having had the efficacy event (imputation). CI for single event rate was calculated based on the Wald asymptotic confidence limits.|Day 1 up to 12 Months|Intent to treat: all randomized participants with valid consent. (n) number of events = 22, 25, 33 in apixaban 2.5 mg, apixaban 5 mg, and placebo arms, respectively.||Proportion of participants||95% Confidence Interval|Number
760226|NCT00633893|Secondary|Adjudicated Cardiovascular (CV)-Related Death During the Intended Treatment Period - Randomized Population With Imputation|CV-related death was defined as myocardial infarction, stroke, or other specified cardiovascular event and were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. Participants with missing endpoint information were classified as having had the efficacy event (imputation). CI for single event rate was calculated based on the Wald asymptotic confidence limits.|Day 1 up to 12 Months|Intent to treat: all randomized participants with valid consent. Analyzed per randomized treatment assigned. number of events (n)= 17, 24, 29 in the apixaban 2.5 mg, 5 mg, placebo arms, respectively.||Proportion of Participants||95% Confidence Interval|Number
760227|NCT00633893|Secondary|Adjudicated Venous Thromboembolism (VTE) - Related Death During the Intended Treatment Period - Randomized Population With Imputation|VTE-related death defined as: PE (based on objective diagnostic testing, autopsy), unexplained death (and VTE cannot be ruled out), sudden death (and VTE cannot be ruled out). DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. New/recurrent VTE, death, venous/arterial thromboembolic events, bleeding, thrombocytopenia, acute myocardial infarction and stroke were also adjudicated. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Participants with missing endpoint information were classified as having had the efficacy event (imputation).|Day 1 up to 12 Months|Intent to treat: all randomized participants with valid consent. Analyzed per randomized treatment assigned. (n) number of events = 17, 24, 26 in apixaban 2.5 mg, 5 mg, placebo arms, respectively. CI for single event rate was calculated based on the Wald asymptotic confidence limits.||Proportion of participants||95% Confidence Interval|Number
760228|NCT00633893|Secondary|Adjudicated Nonfatal Pulmonary Embolism (PE) During the Intended Treatment Period - Randomized Population With Imputation|PE was adjudicated/confirmed by a central independent adjudication committee blinded to treatment and was assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. Participants with missing endpoint information were classified as having had the efficacy event (imputation). CI for single event rate was calculated based on the Wald asymptotic confidence limits.|Day 1 up to 12 Months|Intent to treat: all randomized participants with valid consent. Analyzed per randomized treatment assigned. (n) number of events = 23, 25, 37 in apixaban 2.5 mg, 5 mg, placebo arms, respectively.||Proportion of participants||95% Confidence Interval|Number
760229|NCT00633893|Secondary|Adjudicated Nonfatal Deep Vein Thrombosis (DVT) During the Intended Treatment Period - Randomized Population With Imputation|DVT was adjudicated/confirmed by a central independent adjudication committee blinded to treatment and assessed by compression ultrasound and/or venography. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. Participants with missing endpoint information were classified as having had the efficacy event (imputation). Confidence interval (CI) for single event rate was calculated based on the Wald asymptotic confidence limits.|Day 1 up to 12 Months|Intent to treat: all randomized participants with valid consent. Analyzed per randomized treatment assigned. (n) number of events = 19, 28, 72 in apixaban 2.5 mg, 5 mg, placebo arms, respectively.||Proportion of participants||95% Confidence Interval|Number
760230|NCT00633893|Secondary|Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or Cardio Vascular (CV) -Related Death During the Intended Treatment Period - Randomized Population With Imputation|VTE includes nonfatal DVT or nonfatal PE. All index events, DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Composite endpoint included events that occurred any time from randomization until end of the intended treatment period, regardless of whether the participants were receiving drug treatment. Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. If there were missing endpoint data, participants were imputed as having had an efficacy outcome event.|Day 1 up to 12 Months|Intent to treat: all randomized participants with consent.(n)number of events=27, 34, 95 in apixaban 2.5 mg, 5 mg, placebo arms, respectively. The (n)number of imputed events were = 13, 20, 19 in apixaban 2.5 mg, 5 mg, placebo arms, respectively. CI for single event rate was calculated based on the Wald asymptotic confidence limits||proportion of participants||95% Confidence Interval|Number
760231|NCT00633893|Primary|Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or All-Cause Death During the Intended Treatment Period - Randomized Population Without Imputation|VTE included: nonfatal DVT or nonfatal PE. Event rate (proportion of participants with event) calculated as n/N (n=number of events; N=number of participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for these endpoints; participants who had an event during the intended treatment period were counted. Confidence interval (CI) for single event rate was calculated based on the Wald asymptotic confidence limits.|Day 1 up to 12 months|Intent to treat: all randomized participants with valid consent. Analyzed per randomized treatment assigned.(n)number of events = 19, 14, 77 in apixaban 2.5 mg, 5 mg, and placebo arms, respectively. All events were counted; no events were imputed.||Proportion of participants||95% Confidence Interval|Number
760232|NCT00633893|Secondary|Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or VTE-related Death During the Intended Treatment Period - Randomized Population With Imputation|VTE includes nonfatal DVT or nonfatal PE. All index events, DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants with event) calculated as n/N (n=number of events; N=number of participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. For missing endpoint data, participants were imputed as having had a primary efficacy outcome event.|Day 1 up to 12 Months|ITT: all randomized participants with consent. Analyzed per randomized treatment assigned. (n) number of events=27, 34, 92 in apixaban 2.5 mg, 5 mg, placebo arms, respectively. Number of imputed events=13, 20, 19 in apixaban 2.5 mg, 5 mg, placebo arms, respectively. CI for single event rate was calculated based on Wald asymptotic confidence limits.||Proportion of participants||95% Confidence Interval|Number
760233|NCT00633893|Primary|Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or All-Cause Death During the Intended Treatment Period - Randomized Population With Imputation|VTE included: nonfatal deep vein thrombosis (DVT) or nonfatal pulmonary embolism (PE). All index events, DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants with event) calculated as n/N (n=number of events; N=number of participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. For missing endpoint data, participants were imputed as having had a primary efficacy outcome event.|Day 1 up to 12 Months|Intent to treat: all randomized participants with consent. Analyzed per randomized treatment assigned. (n) number of events=32, 34, 96 in apixaban 2.5 mg, 5 mg, and placebo arms, respectively; number of events imputed=13, 20, 19, respectively. Confidence interval (CI) for event rate was calculated based on the Wald asymptotic confidence limits.||Proportion of participants||95% Confidence Interval|Number
760234|NCT00633919|Secondary|Global Evaluation of Efficacy by Subject and Investigator at the End of the Evaluation Period in Autumn 2007|"The treatment efficacy was rated by both subject and investigator at the end of the evaluation period in autumn 2007. Subjects rated their asthma symptoms in comparison to previous autumns and investigators rated the asthma symptoms in comparison to when subjects entered the trial, using the categories: “much worse”, “worse”, “the same”, “better”, or “much better”.
The categories “much better” or “better” were grouped as “improved”. The categories “the same”, “worse” or “much worse” were grouped as “not improved”."|8 weeks|All analyses were on all randomised participants (full analysis set) with data in 2007: All available data were used to their full extent, but no imputation of data was performed.||Participants|||Number
760235|NCT00633919|Secondary|Global Evaluation of Efficacy by Investigator at the End of the Evaluation Period in Autumn 2008|"The treatment efficacy was rated by investigators at the end of the evaluation period in autumn 2008. Investigators rated the asthma symptoms in comparison to when subjects entered the trial, using the categories: “much worse”, “worse”, “the same”, “better”, or “much better”.
The categories “much better” or “better” were grouped as “improved”. The categories “the same”, “worse” or “much worse” were grouped as “not improved”."|8 weeks|All analyses were on all randomised participants (full analysis set) with data in 2008: All available data were used to their full extent, but no imputation of data was performed.||Participants|||Number
760263|NCT00634088|Secondary|Area Under the Concentration-time Curve From 0 to Infinity (AUC[INF]) and AUC From 0 to Last Quantifiable Concentration (AUC[O-T] of Ixabepilone||Day 1 of 21-day cycle|Participants who received ixabepilone with lapatinib treatment and had pharmacokinetic parameters available.||ng*h/mL||Standard Deviation|Geometric Mean
760237|NCT00633919|Secondary|Average Daily Asthma Medication Score During a 2-months Evaluation Period in Autumn 2007|"Scoring per inhalation/tablet: 1-2 inhalations twice daily of salbutamol (200 ug per inhalation), 2 scores; 1-2 inhalation twice daily of budesonide/formoterol 80 (4.5 ug per inhalation), 4 scores; 1 inhalation twice daily of budesonide/formoterol 160 (4.5 ug per inhalation), 8 scores; up to 10 tablets once daily of prednisone (5 mg), 1.6 scores. The total maximum daily scores were 40.
The daily score for each medication step was calculated by multiplying the score per inhalation/tablet with the number of inhalations/tablets used (entered as units in the daily diary by the subject)."|8 weeks|Data were based on subjects from the Full Analysis Set (FAS; all randomised subjects following the ITT ICH principle) who had at least one record in the daily diary in the 2 months evaluation period in autumn 2007. All available data were used to their full extent, but no imputation of data was performed.||Scores on a scale||Standard Deviation|Mean
760238|NCT00633919|Primary|Average Daily Asthma Medication Score During a 2-months Evaluation Period in Autumn 2008|"Scoring per inhalation/tablet: 1-2 inhalations twice daily of salbutamol (200 ug per inhalation), 2 scores; 1-2 inhalation twice daily of budesonide/formoterol 80 (4.5 ug per inhalation), 4 scores; 1 inhalation twice daily of budesonide/formoterol 160 (4.5 ug per inhalation), 8 scores; up to 10 tablets once daily of prednisone (5 mg), 1.6 scores. The total maximum daily scores were 40.
The daily score for each medication step was calculated by multiplying the score per inhalation/tablet with the number of inhalations/tablets used (entered as units in the daily diary by the subject)."|8 weeks|Data were based on subjects from the Full Analysis Set (FAS; all randomised subjects following the ITT ICH principle) who had at least one record in the daily diary in the 2 months evaluation period in autumn 2008. All available data were used to their full extent, but no imputation of data was performed.||Scores on a scale||Standard Deviation|Mean
760239|NCT00633932|Secondary|"Number of Participants With Healing of Reflux Esophagitis (RE) Who Were Graded O at Week 4 Out of Patients Who Were Graded A, B, C or D at Baseline According to Los Angeles Classification"|Los Angeles classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). The subjects who were definitely diagnosed to have RE classified into LA classification Grade A, B, C or D based on the EGD on Visit 1 were randomised. A subject classified into LA classification Grade O was considered no reflux esophagitis. The definitions of each grade are: Grade A (Mucosal break < 5 mm in length), Grade B (Mucosal break > 5mm), Grade C (Mucosal break continuous between > 2 mucosal folds) and Grade D (Mucosal break >75% of esophageal circumference).|4 weeks|One participant for each treatment group did not take any investigational product. These 3 participants were excluded (1 for each treatment group) from all the efficacy and safety analyses.||participants|||Number
760240|NCT00633932|Primary|"Number of Participants With Healing of Reflux Esophagitis (RE) Who Were Graded O at Week 8 Out of Patients Who Were Graded A, B, C or D at Baseline According to Los Angeles Classification."|Los Angeles classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C, Grade D). The subjects who were definitely diagnosed to have RE classified into LA classification Grade A, B, C or D based on the EGD on Visit 1 were randomised. A subject classified into LA classification Grade O was considered no reflux esophagitis. The definitions of each grade are: Grade A (Mucosal break < 5 mm in length), Grade B (Mucosal break > 5mm), Grade C (Mucosal break continuous between > 2 mucosal folds) and Grade D (Mucosal break >75% of esophageal circumference).|8 weeks|One participant for each treatment group did not take any investigational product. These 3 participants were excluded (1 for each treatment group) from all the efficacy and safety analyses.||participants|||Number
760241|NCT00633984|Primary|CGI - Clinical Global Impression of Improvement|"The Clinician Global Impression-Improvement Scale (CGI-I) is a clinician-rated instrument used to assess global severity of symptoms. The CGI-I ranges from 1 (very much improved) to 7 (very much worse). Response and remission was defined as an improvement score of 1 (very much improved) or 2 (much improved) on the CGI-I."|Week 13|||units on a scale||95% Confidence Interval|Mean
760242|NCT00633984|Primary|Liebowitz Social Anxiety Scale (LSAS)|The Liebowitz Social Anxiety Scale (LSAS) is a 24-item measure designed to assess both fear and avoidance of social and performance situations occurring in the last week. Each item is rated from 0-3 for both fear and avoidance with a possible score of 144; 55-65 Moderate social phobia, 65-80 Marked social phobia, 80-95 Severe social phobia, and Greater than 95 - Very severe social phobia. Remission was defined as a score of < 30 on the Liebowitz Social Anxiety Scale|Week 13|||units on a scale||95% Confidence Interval|Mean
760243|NCT00634010|Primary|Participant Pain Severity Score Measured Using Brief Pain Inventory|Brief Pain Inventory (BPI): Pain severity measured with BPI, which asks participants to rate pain for last 24 hours on 0 to 10 scales at its “worst”, “least”, “average “ and “now”. The scales are presented on a 10 cm line, with each number equidistant from the next. Each scale is bounded by the words “no pain’ at the 0 end and “pain as bad as you can imagine” at the other. BPI used to determine whether methadone used as first line strong opioid is superior to morphine as evidenced by reduced pain over a 4 week (+/- 3 days) treatment period in participants with advanced cancer.|Comparing baseline and pain scores at 4 weeks (+/- 3 days)|The study was terminated without completing any analysis because the sample size was too small to detect any differences between the groups. Participants eligible for the study often had significant symptom distress and could not continue in the four week study period needed for data collection contribution to mean calculation.|||||
760244|NCT00634036|Secondary|Exhaled Nitric Oxide Ppb||12 weeks|||ppb||Standard Deviation|Mean
760245|NCT00634036|Secondary|Juniper Asthma Control Questionnaire|The Juniper Asthma Control Questionnaire is a validated scale ranging from 0 to 6. Higher scores represent poorer asthma control. Values > 1.5 are compatible with poorly controlled asthma|12 weeks|||Scores on a scale||Standard Deviation|Mean
760246|NCT00634036|Secondary|FEV1 % Predicted||12 weeks|||% predicted||Standard Deviation|Mean
760247|NCT00634036|Primary|Airway Reactivity|Presence and degree of airway hyperresponsiveness assessed by methacholine challenge test. PC20= Methacholine dose at wich the FEV1 deops by > 20% from pre-methacholine baseline values.|12 weeks|||mg/ml||Inter-Quartile Range|Median
760248|NCT00634049|Secondary|Safety - Overall Number of TEAEs|A Treatment Emergent Adverse Events (TEAE) is any adverse event that starts after the first administration of study drug until 28 days after the last dose of study drug.|From the first study drug administration until 28 days after the last dose of study drug|The safety analysis set (SAF) consists of all enrolled participants who received at least one dose of study drug as this was a non-comparative open-label study||participants|||Number
760250|NCT00634049|Secondary|Crude Success Rate of Radiological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT|"The Investigator evaluated radiological response to treatment at day 42, day 84 and EOT. Radiological response outcomes were described as Success [≥ 90% improvement,≥ 50% to < 90% improvement and ≥ 25% to < 50% improvement (for day 42 and EOT, if EOT occurs prior to day 42)].
End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days."|Day 42, Day 84 and End of Treatment (EOT [Day 180])|Modified Intent-To-Treat population (mITT)||percentage of participants|||Number
760251|NCT00634049|Secondary|Crude Success Rate of Mycological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT|"The Investigator evaluated mycological response to treatment at day 42, day 84 and EOT. Mycological response outcomes were described as Success [Eradication,Presumed eradication].
End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days."|Day 42, Day 84 and End of Treatment (EOT [Day 180])|Modified Intent-To-Treat population (mITT)||percentage of participants|||Number
760252|NCT00634049|Secondary|Crude Success Rate of Clinical Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT|"The Investigator evaluated clinical response to treatment at day 42, day 84 and EOT. Clinical response outcomes were described as Success [Resolution of all attributable clinical symptoms and physical findings] and [Resolution of some attributable clinical symptoms and physical findings].
End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days."|Day 42, Day 84 and End of Treatment (EOT [Day 180])|Modified Intent-To-Treat population (mITT)||percentage of participants|||Number
760253|NCT00634049|Secondary|Crude Success Rate of Radiological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT|"The DRC evaluated radiological response to treatment at at day 42, day 84 and EOT. Radiological response outcomes were described as Success [Improvement of at least 25% from baseline for invasive aspergillosis and other filamentous mold infections], [Improvement of at least 50% from baseline for invasive aspergillosis and other filamentous mold infections]; and [Improvement of at least 25% from baseline if EOT occurs prior to day 42 and at least 50% improvement from baseline if EOT occurs after day 42 for invasive aspergillosis and other filamentous mold infections].
End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days."|Day 42, 84 and End of Treatment (EOT [Day 180])|Modified Intent-To-Treat population (mITT)||percentage of participants|||Number
760254|NCT00634049|Secondary|Crude Success Rate of Mycological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT|"The DRC evaluated mycological response to treatment at day 42, day 84 and EOT. Mycological response outcomes were described as Success [Eradication and Presumed eradication].
End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days."|Day 42, 84 and End of Treatment (EOT [Day 180])|Modified Intent-To-Treat population (mITT)||percentage of participants|||Number
760255|NCT00634049|Secondary|Crude Success Rate of Clinical Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT|"The DRC evaluated clinical response to treatment at day 42, day 84 and EOT. Clinical response outcomes were described as Success [Resolution of all attributable clinical symptoms and physical findings and Partial resolution of attributable clinical symptoms and physical findings].
End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days."|Day 42, 84 and End of Treatment (EOT [Day 180])|Modified Intent-To-Treat population (mITT)||percentage of participants|||Number
760256|NCT00634049|Primary|Crude Success Rate of Overall Outcome of Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and End of Treatment (EOT).|"The DRC assessed overall response based on individual clinical, mycological and radiological response assessments. Overall response outcomes were described as Success (complete or partial). Complete success was defined as a resolution of all clinical symptoms and physical findings associated with IFD. Partial success was defined as a resolution of at least some clinical symptoms and physical findings associated with IFD
End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days."|Day 42, 84 and End of Treatment (EOT [Day 180])|Modified Intent-To-Treat population (mITT)||percentage of participants|||Number
760257|NCT00634088|Secondary|Duration of Response of Combination Treatment With Ixabepilone Plus Lapatinib|Duration of response is measured from the time in months that measurement criteria are first met for PR or CR, whichever is recorded first, until the date of documented PD or death. Participants who neither relapse nor die will be censored on the date of their last tumor assessment.|First occurrence of PR or CR to PD or Death (no average, as no data available)|Because the study was terminated due to insufficient enrollment, the duration of response could not be analyzed.|||||
760258|NCT00634088|Secondary|Overall Tumor Response By Number of Participants|Target lesion criteria: Complete Response(CR)=Disappearance of all clinical and radiologic evidence of target lesions; Partial Response (PR)=A 30% or greater decrease in the sum of longest diameter(LD) of all lesions in reference to the baseline sum LD. Stable Disease (SD)=Insufficient increase to qualify for Progressive Disease (PD) and insufficient shrinkage to qualify for PR; PD=A 20% or greater increase in the sum of LD of all target lesions, taking as reference the smallest sum LD recorded at or following baseline.|Baseline and Day 21 (21-day cycle)|All participants with measurable disease at baseline per RECIST guidelines, with the exception of those with an incorrect diagnosis.||Participants|||Number
760259|NCT00634088|Primary|MTD and RP2D of Ixabepilone When Administered With Lapatinib Plus Capecitabine|MTD is defined as the maximum dose that can be administered to 6 participants such that no more than 1 (or fewer than one third if more than 6 participants receive treatment) experiences a DLT, with at least 2 experiencing a DLT at the next higher dose level. The RP2D is based on the MTD and the assessment of any relevant chronic toxicities.|Days 1 through 21|Because the study was terminated due to insufficient enrollment, no participants received the triplet combination.|||||
760260|NCT00634088|Secondary|Volume of Distribution at Steady State of Ixabepilone||Day 1 of 21-day cycle|Participants who received ixabepilone with lapatinib treatment and had pharmacokinetic parameters available.||Liters||Standard Deviation|Mean
760261|NCT00634088|Secondary|Time to Peak Concentration of Ixabepilone||Day 1 of 21-day cycle|Participants who received ixabepilone with lapatinib treatment and had pharmacokinetic parameters available.||Hours||Full Range|Median
760262|NCT00634088|Secondary|Terminal Half-life of Ixabepilone||Day 1 of 21-day cycle|Participants who received ixabepilone with lapatinib treatment and had pharmacokinetic parameters available.||Hours||Standard Deviation|Mean
760265|NCT00634088|Secondary|Number of Participants With Abnormalities in Serum Chemistry Laboratory Results by Worst CTC Grade|CTC, Version 3.0 used to assess parameters. ULN=upper level of normal among all laboratory ranges. ALT(U/L) Gr 1:>ULN–2.5*ULN,Gr 2:>2.5–5.0*ULN,Gr 3:>5.0–20.0*ULN,Gr 4:>20.0* ULN; AST(U/L) Gr 1:>ULN–2.5* ULN,Gr 2:>2.5–5.0*ULN,Gr 3:>5.0–20.0*ULN,Gr 4:>20.0* ULN; ALP(U/L)Gr 1:>ULN–2.5*ULN, Gr 2:>2.5–5.0*ULN, Gr 3:>5.0-20.0*ULN, Gr 4:>20.0*ULN; Creatinine (mg/dL): Gr 1:>ULN–1.5*ULN, Gr 2:>1.5–3.0*ULN, Gr 3:>3.0–6.0*ULN, Gr 4:>6.0*ULN; Total bilirubin (mg/dL): Gr 1:>ULN–1.5*ULN, Gr 2:>1.5–3.0*ULN, Gr 3:>3.0–10.0*ULN, Gr 4:>10.0*ULN|At baseline and within 72 hours of Day 1 of 21-day cycle|All participants who received at least 1 dose of ixabepilone and either lapatinib or capecitabine.||Participants|||Number
760266|NCT00634088|Secondary|Number of Participants With Abnormalities in Hematology Laboratory Results by Worst CTC Grade|CTC, Version 3.0 used to assess parameters. ULN=upper level of normal among all laboratory ranges. WBC (c/L): Grade (Gr)1:<LLN to 3.0*10^9/L, Gr 2:<3.0 to 2.0*10^9/L, Gr 3:<2.0 to 1.0*10^9/L, Gr 4:<1.0*10^9/L; ANC (c/uL): Gr 1:<LLN to 1.5*10^9/L, Gr 2:<1.5 to 1.0*10^9/L, Gr 3:<1.0 to 0.5*10^9/L, Gr 4:<0.5*10^9/L; Platelet count (c/uL): Gr 1:LLN to 75.0*10^9/L, Gr 2:<75.0 to 50.0*10^9/L, Gr 3:<50.0 to 25.0*10^9/L, Gr 4:<25.0*10^9/L; Hemoglobin (g/dL): Gr 1:<LLN to 10.0 g/dL, Gr 2:<10.0 to 8.0 g/dL, Gr 3:<8.0 to 6.5 g/dL, Gr 4:<6.5 g/dL.|Baseline and weekly from Days 1 to 21 (Cycle 1)|All participants who received at least 1 dose of ixabepilone and either lapatinib or capecitabine.||Participants|||Number
760267|NCT00634088|Secondary|Number of Participants With DLT|DLT=Any of the following events, attributable to study drug and occurring within 21 days after ixabepilone administration: Grade 3 or 4 nausea, vomiting, or diarrhea despite the use of adequate medical intervention; other Grade 3 or greater nonhematologic toxicity requiring removal from study drug; recovery from study drug-related toxicity that delayed scheduled retreatment for longer than 3 weeks; Grade 4 neutropenia for 5 or more consecutive days or Grade 3 or 4 neutropenia of any duration with sepsis or fever; thrombocytopenia or bleeding requiring platelet transfusion.|Baseline to Day 21, continuously|All participants who received at least 1 dose of ixabepilone and either lapatinib or capecitabine.||Participants|||Number
760268|NCT00634088|Secondary|Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, Treatment-related AEs, Treatment-related AEs (Grade 3 or 4), Peripheral Neuropathy (PN), PN (Grade 3 or 4)|AE=Any new untoward medical event or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical event that results in death, persistent or significant disability/incapacity, drug dependency or abuse; is life-threatening, important, a congenital anomaly/birth defect; or requires or prolongs existing hospitalization. Treatment related=possibly, probably, or certainly related to and of unknown relationship to study treatment. Common Terminology Criteria (CTC) Grade 3=severe; Grade 4=life-threatening or disabling.|Baseline to Day 21, continuously|All participants who received at least 1 dose of ixabepilone and either lapatinib or capecitabine.||Participants|||Number
760269|NCT00634088|Primary|Maximum Tolerated Dose (MTD) and Recommended Phase II Dose (RP2D) of Ixabepilone When Administered With Lapatinib|The MTD is defined as the maximum dose that can be administered to 6 participants such that no more than 1 (or fewer than one third if more than 6 participants receive treatment) experiences a dose-limiting toxicity (DLT), with at least 2 experiencing a DLT at the next higher dose level. The RP2D is based on the MTD and the assessment of any relevant chronic toxicities.|Days 1 through 21|Because the study was terminated due to insufficient enrollment, MTD was not achieved.|||||
760270|NCT00634114|Secondary|Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 12 Weeks After Treatment|Los Angels classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). A patient classfied into Grade O was considered no reflux esophagitis. The participants who had a healing of reflux esophagitis with Grade O at Visit 1 were randomised. Number of participants who did not have Grades A-D up to 12 weeks after treatment was evaluated.|Up to 12 weeks|||Participants|||Number
760271|NCT00634114|Primary|Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification Throughout the Treatment Period.|Los Angels classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). A patient classfied into Grade O was considered no reflux esophagitis. The participants who had a healing of reflux esophagitis with Grade O at Visit 1 were randomised. Number of participants who did not have Grades A-D throughout the treatment period was evaluated.|Up to 24 weeks|||Participants|||Number
760272|NCT00634114|Secondary|Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 4 Weeks After Treatment|Los Angels classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). A patient classfied into Grade O was considered no reflux esophagitis. The participants who had a healing of reflux esophagitis with Grade O at Visit 1 were randomised. Number of participants who did not have Grades A-D up to 4 weeks after treatment was evaluated.|up to 4 weeks|||Participants|||Number
760273|NCT00634166|Secondary|The Secondary Objective is to Examine the Reasons for Graft Loss in Subjects Treated With Sulfamylon® Solution Versus Historical Controls.||Secondary analyses will include the percent of subjects with All Cause Graft Loss at Days 12-14 and Days 18-21; Treatment Failure at Days 5-7; and Infectious Graft Loss at Days 5-7, Days 12-14 and Days 18-21.||||||
760274|NCT00634166|Primary|Percentage of Participants With Graft Loss After Initial Meshed Autograft Procedure on Days 5-7.||The primary analysis will compare the percent of subjects with All Cause Graft Loss of the initial meshed autograft procedure at Days 5-7.|||Percentage of Participants|||Number
760275|NCT00634179|Secondary|An Estimate of the Overall Response Rate (ORR)(Complete Response [CR] + CR Unconfirmed [CRu] + Partial Response [PR]) to Bortezomib and Rituximab (VR)-CHOP According to International Workshop to Standardize Response Criteria (IWRC) Criteria|Response was assessed by computerized tomography (CT) after every 2 cycles of induction therapy, one time at least 4 weeks after completing induction (i.e., prior to maintenance), and then every 3 months while on maintenance therapy. At the conclusion of maintenance therapy, patients underwent one post-treatment scan, with further scans completed at the discretion of the treating physician. Positron emission tomography was permitted but only CT measurements were used to determine response.|Following completion of therapy, up to 2 years|||participants|||Number
760310|NCT00634582|Primary|Biochemical Markers (i.e., Serum Parathyroid Hormone [PTH], Bone-specific Alkaline Phosphatase, and Osteocalcin) That Are Surrogates for Fracture Risk and Are Associated With Increased Bone Pain, Morbidity, and Mortality From Prostate Cancer||16 weeks|This trial was closed for slow accrual. For cost reasons, analysis was to be done in a batch size never reached, so the analysis was not done.|||||
760276|NCT00634179|Primary|Maximal Tolerated Doses of Bortezomib and Vincristine When Used in Combination of Bortezomib, Rituximab and the CHOP Chemotherapy Regimen (Phase I)|INDUCTION: Patients receive bortezomib IV on days 1 and 8; rituximab IV, doxorubicin hydrochloride IV over 3-5 minutes, cyclophosphamide IV over 60 minutes, and vincristine sulfate IV over 10 minutes on day 1; and prednisone PO on days 1-5. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression.|Cycle 1 for MTD, following completion of therapy for CR, up to 24 weeks|||mg/m^2||95% Confidence Interval|Number
760277|NCT00634244|Secondary|The Rate of Treatment Failure|"The definition of treatment failure will include:
≥ 5% leukemic blasts at the time of pre-consolidation marrow
Death during/following induction chemotherapy (pre-consolidation)
Persisting marrow hypoplasia and pancytopenia for ≥ 2 months after chemotherapy
CNS or extramedullary disease at the time of pre-consolidation
Leukemia persistence after completion of induction treatment. Leukemia persistence is defined as greater than 10% residual blasts on marrow biopsy done 5-7 days after completion of induction chemotherapy"|Assessed every 3 months for the first 2 years and then every 6 months until relapse or death up to 3 years from registration.|Eligible and treated||proportion of participants||90% Confidence Interval|Number
760278|NCT00634244|Primary|The Rate of Complete Remission (CR+CRi)|CR requires: 1. peripheral blood counts: neutrophil count ≥ 1.0 x 10^9/L, platelet count ≥ 100 x 10^9/L, reduced hemoglobin concentration or hematocrit has no bearing on remission status, and leukemic blasts must not be present in the peripheral blood. 2. bone marrow aspirate and biopsy: maturation of all cell lines must be present, ≤ 5% blasts, auer rods must not be detectable. 3. extramedullary leukemia, such as central nervous system (CNS) or soft tissue involvement, must not be present. CRi requires that all criteria for complete remission be satisfied except patients can have residual neutropenia (<1 x 10^9/L) or thrombocytopenia (<100 x 10^9/L).|Assessed every 3 months for the first 2 years and then every 6 months until relapse or death up to 3 years from registration.|Eligible and treated||proportion of participants||90% Confidence Interval|Number
760279|NCT00634270|Primary|To Characterize the Pharmacokinetic Profile of Sirolimus When Administered to This Patient Population - Therapeutic Dose (mg/kg)^0.75|An iterative 2-stage Bayesian method was used for the PK parameter analyses|Pre-dose; Day 1 at 0.5 hours, 1.0 hours, 2.0 hours, 3.0 hours, 4.0 hours, 6.0 hours, 8.0 hours, and 10.0 to 12.0 hours|Stratum 1, Neurofibromatosis Type 1 patients (ages 3 to 18) - Therapeutic Dose (mg/kg)^0.75. Stratum 2 did not meet the 6 month response criteria; therefore, was not analyzed for pharmacokinetic profiles.||Therapeutic Dose (mg/kg)^0.75||Standard Deviation|Mean
760280|NCT00634270|Secondary|To Evaluate the Role of Apolipoprotein E Genotypes as Predictors for Development of Hyperlipidemia During Therapy With Sirolimus.|Number of patients who experienced hyperlipidemia is being reported.|24 weeks Stratum 1 / 48 weeks Stratum 2|||participants|||Number
760281|NCT00634270|Secondary|To Evaluate Pharmacogenetic Polymorphisms of Cytochrome P450 3A4 & 3A5 Alleles and P-glycoprotein/MDR for Their Influence on the Metabolism of Sirolimus in This Patient Population.|Trough concentration of sirolimus is reported in nanograms per mL.|24 weeks Stratum 1 Only|Subjects in Stratum 1.||ng/mL||Standard Deviation|Mean
760282|NCT00634270|Secondary|To Evaluate the Effect of Sirolimus on Clinical Response by Reduction in Pain, or Improvement in Function or Performance Scale.|There were no data collected for this outcome measure.|24 weeks Stratum 1 / 48 weeks Stratum 2||||||
760283|NCT00634270|Secondary|To Asses Preliminary Correlations of Radiographic Response With Changes in Pharmacodynamics Parameters Including p70s6 Kinase Activity in Peripheral Blood Mononuclear Cells.|Response by Volumetric MRI.|24 weeks Stratum 1 / 48 weeks Stratum 2|Samples were inadequate in quantity to allow for this analysis.|||||
760284|NCT00634270|Primary|To Characterize the Pharmacokinetic Profile of Sirolimus in When Administered to This Patient Population - Therapeutic Dose (mg/kg Per Dose)|An iterative 2-stage Bayesian Method was used for the PK parameter analyses|Pre-dose; Day 1 at 0.5 hours, 1.0 hours, 2.0 hours, 3.0 hours, 4.0 hours, 6.0 hours, 8.0 hours, and 10.0 to 12.0 hours|Stratum 1, Neurofibromatosis Type 1 patients (Ages 3 to 18) Therapeutic Dose (mg/kg per dose). Stratum 2 did not meet the 6 month response criteria; therefore, was not analyzed for pharmacokinetic profiles.||Therapeutic Dose (mg/kg per dose)||Standard Deviation|Mean
760285|NCT00634270|Primary|To Characterize the Pharmacokinetic Profile of Sirolimus When Administered to This Patient Population- Therapeutic Dose (mg/m^2 Per Dose)|An iterative 2-stage Bayesian Method was used for the PK parameter analyses|Pre-dose; Day 1 at 0.5 hours, 1.0 hours, 2.0 hours, 3.0 hours, 4.0 hours, 6.0 hours, 8.0 hours, and 10.0 to 12.0 hours|Stratum 1, Neurofibromatosis Type 1 patients - Therapeutic Dose (mg/m^2 per dose). Stratum 2 did not meet the 6 month response criteria; therefore, was not analyzed for pharmacokinetic profiles.||Therapeutic Dose mg/m^2 per dose||Standard Deviation|Mean
760286|NCT00634270|Primary|To Characterize the Pharmacokinetic Profile of Sirolimus When Administered to This Patient Population - (Clearance (L/h Per 1.85 m^2)|An iterative 2-stage Bayesian Method was used for the PK parameter analyses|Pre-dose; Day 1 at 0.5 hours, 1.0 hours, 2.0 hours, 3.0 hours, 4.0 hours, 6.0 hours, 8.0 hours, and 10.0 to 12.0 hours|Stratum 1, Neurofibromatosis Type 1 Patients Clearance (L/h per 1.85 m^2). Stratum 2 did not meet the 6 month response criteria; therefore, was not analyzed for pharmacokinetic profiles.||L/h per 1.85 m^2||Standard Deviation|Mean
760287|NCT00634270|Primary|To Characterize the Pharmacokinetic Profile of Sirolimus When Administered to This Patient Population Using Liters/Hour Per Population Median Weight of 70kg (L/h70kg)|An iterative 2-stage Bayesian method was used for the PK parameter analyses|Pre-dose; Day 1 at 0.5 hours, 1.0 hours, 2.0 hours, 3.0 hours, 4.0 hours, 6.0 hours, 8.0 hours, and 10.0 to 12.0 hours|Stratum 1 used allometrically scaled clearance (clearance scaled to a 70kg individual). Stratum 2 did not meet the 6 month response criteria; therefore, was not analyzed for pharmacokinetic profiles.||L/h/70kg||Standard Deviation|Mean
760288|NCT00634270|Secondary|To Assess the Value of Three-dimensional MRI (3-D MRI) in the Evaluation of Plexiform Neurofibromas and Paraspinal Neurofibromas, and to Compare 3-D MRI to Conventional Two-dimensional MRI (2-D MRI) and One Dimensional MRI (1-D MRI) Data Analysis|The study provided central review of all MRIs using a three-dimensional volumetric protocol. As the STOPN protocol began, research had already demonstrated the superiority of this approach to 1-D or 2-D analyses, so these were not used in the STOPN study.|24 weeks Stratum 1 / 48 weeks Stratum 2||||||
760330|NCT00625391|Secondary|Oxidative Stress Damage Biomarker|Oxidative stress damage biomarker: urinary 8-hydroxy-2'-deoxyguanosine (8-OHdG) test|24 weeks|Analyzed who completed the study.||ng/mg creatinine||Standard Deviation|Mean
760289|NCT00634270|Secondary|To Evaluate the Quality of Life During Treatment With Sirolimus by Assessing Preliminary Correlations of Response With Quality-of-life Outcomes|Self-reported, age-appropriate PedsQL Scale. Assessments included: Inventory for physical function, emotional function, social function and school function - number system 0-4 was used with 4 being the worse maximum threshold); inventory for chronic illness used a 5-point likert scale - 5 being the worst maximum threshold; Skindex-Teen used a scale of 0 to 100 - the higher the number the more frequent the experience; Pain intensity was measured using a line with a happy and sad face - marks toward the sad face indicated more intense pain; and, the McGill Pain Questionnaire - higher values indicating worse pain of a scale from 0-3. All assessments were combined for an overall PedsQL score by rating each item 0-4, then reverse transforming each to a 0 - 100 scale. The total scores were calculated by averaging the item scores, with higher scores being better.|24 weeks Stratum 1 / 48 weeks Stratum 2|Stratum 1 patients with Neurofibromatosis Type 1; all ages - Change from Baseline to Course 3. Stratum 2 did not meet the requirements for response at the 6 month time point. Therefore, Stratum 2 was not analyzed for this aim.||Units on a scale||Standard Deviation|Mean
760290|NCT00634270|Primary|To Characterize the Pharmacokinetic Profile of Sirolimus Administered to This Patient Population (Clearance Liters/Hour (L/h))|An iterative 2-stage Bayesian method was used for the PK parameter analyses|Pre-dose; Day 1 at 0.5 hours, 1.0 hours, 2.0 hours, 3.0 hours, 4.0 hours, 6.0 hours, 8.0 hours, and 10.0 to 12.0 hours|Pediatric Patients (3 through 18) with Neurofibromatosis Type 1 - Clearance liters/hour (L/h). Stratum 2 did not meet the 6 month response criteria; therefore, was not analyzed for pharmacokinetic profiles.||Clearance liters/hour (L/h)||Standard Deviation|Mean
760291|NCT00634270|Primary|Toxicity|Number of participants experiencing adverse events|24 weeks Stratum 1 / 48 weeks Stratum 2|All evaluable participants for Stratum 1 and 2 combined.||Participants|||Number
760292|NCT00634270|Primary|Results in Objective Radiographic Responses Based on Volumetric MRI Measurements in Children and Adults With NF1 and Inoperable PN in the Absence of Documented Radiographic Progression at Trial Entry|Stratum 2 outcome - Response|48 weeks Stratum 2|Identify the index plexiform neurofibroma(s) for 3-D MRI evaluation based on prior imaging studies. The criteria for response was <20% increase in volume using RECIST v1.0. Response for 48 weeks was only assessed for Stratum 2.||participants|||Number
760293|NCT00634270|Primary|Time to Disease Progression Based on Volumetric MRI|Median time to progression in Stratum 1 as defined as an increase of at least 20% of the volume of the primary lesion. Note: Since Stratum 2 looked at response rate only, median time to progression was not reviewed for this outcome.|24 Months Stratum 1|"All evaluable participants. Note: In Stratum 2 the value was not assessed as time to progression therefore the appropriate response would be N/A. Stratum 2 was reported as response rate only."||Months||95% Confidence Interval|Median
760294|NCT00634322|Primary|Patients Progressing to Next Chemotherapy Cycle||1 week after intervention||||||
760295|NCT00634504|Primary|Pharmacokinetics (PK) of Leucovorin|Geometric mean 6S-leucovorin area under the curve|3 hours post LV administration|||micromol x hour/L||95% Confidence Interval|Geometric Mean
760296|NCT00634543|Secondary|Change From Baseline in Short Form-36 (SF-36) Score at Day 43|The SF-36 is designed to assess the health status of participants. The SF-36 includes 1 multi-item scale measuring physical health and mental health. Physical health includes physical functioning, role limitations due to physical health, pain and general health. Mantal health includes role limitations due to emotional problems, energy/fatigue, emotional well being and social functioning. Each item is scored on a 0-100 range so that the lowest and highest possible scores are set at 0 and 100, respectively. All items are scored so that a high score defines a more favorable health state.|Baseline and Day 43|FAS included all randomly assigned participants who met the eligibility criteria and had at least 1 post-baseline efficacy assessment data. Here 'n' signifies number of participants who were evaluated for at given time point.||Units on a scale||Standard Deviation|Mean
760297|NCT00634543|Secondary|Change From Baseline in Brief Pain Inventory (BPI) Score at Day 43|The BPI is a questionnaire designed to assess the severity and impact of pain on quality of life. Pain severity score is caculated by sum of all severity items (pain worst, pain least, pain average and pain now) divided by pain now. Total score for pain severity ranges from 0=no pain to 10=extreme pain. Pain interference score was calculated by sum of all interference items (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life) score. Total score for pain interference ranges from 0=no interference to 70= interferes completely.|Baseline and Day 43|FAS included all randomly assigned participants who met the eligibility criteria and had at least 1 post-baseline efficacy assessment data. Here 'n' signifies number of participants who were evaluated for this outcome measure at a particular time point.||Units on a scale||Standard Deviation|Mean
760298|NCT00634543|Secondary|Overall Assessment of Study Medication by Investigator|Overall assessment of study medication was done by Investigator. Assessment was made on a scale of -2 to 2 where, -2=very bad, -1=bad, 0=no change, 1= good and 2=very good.|Day 43|FAS included all randomly assigned participants who met the eligibility criteria and had at least 1 post-baseline efficacy assessment data. Here ‘N’ signifies number of participants who were evaluated for this outcome measure.||Percentage of participants|||Number
760299|NCT00634543|Secondary|Overall Assessment of Study Medication by Participants|Overall assessment of study medication was done by participants. Assessment was made on a scale of -2 to 2 where, -2=very bad, -1=bad, 0=no change, 1= good and 2=very good.|Day 43|FAS included all randomly assigned participants who met the eligibility criteria and had at least 1 post-baseline efficacy assessment data. Here ‘N’ signifies number of participants who were evaluated for this outcome measure.||Percentage of participants|||Number
760300|NCT00634543|Secondary|Percentage of Participants With Pain Relief|Pain relief was assessed on a scale ranging from -1 to 4, where -1=became worse, 0=no change, 1=relieved a little, 2=relieved moderately, 3=relieved a lot and 4=completely resolved.|Day 15, Day 29 and Day 43|FAS included all randomly assigned participants who met the eligiblility criteria and had at least 1 post-baseline efficacy assessment data. Last observation carried forward (LOCF) was used.||Percentage of Participants|||Number
760301|NCT00634543|Primary|Change From Baseline in Pain Intensity Score at Day 43|Pain intensity was assessed on 11-point numerical rating scale ranging from 0=no pain to 10=pain as bad as you can imagine.|Baseline and Day 43|Full analysis set (FAS) included all randomly assigned participants who met the eligiblility criteria and had at least 1 post-baseline efficacy assessment data. Last observation carried forward (LOCF) was used.||Units on a scale||Standard Deviation|Mean
760311|NCT00634621|Secondary|Assess the Sensitivity of Standard White Light Cystoscopy (WLC) and Blue Light Cystoscopy (BLC) for Obtaining a Correct Diagnosis of Bladder Cancer at Individual Patient Level.|The number of confirmed bladder cancer matches using cystoscopy compared to the diagnostic gold standard, i.e. histological examination of lesions biopsy.|Day 0 (Post contrast administration)|The number of confirmed bladder cancer was 219 identified by the standard of truth methods using the White-light cystoscopy and blue-light cystoscopy technique.||Percentage of confirmed Lesions||95% Confidence Interval|Number
760312|NCT00634621|Primary|Detecting the Rate of Bladder Cancer Lesions by White-Light Cystoscopy (WLC) and Blue-Light Cystoscopy (BLC) With Hexvix® in the Overall Study Population by Comparison With the Diagnostic Gold Standard, i.e. Histological Examination of Lesions Biopsy.|Detecting the number of bladder cancer lesions by White-Light Cystoscopy (WLC) and Blue-Light Cystoscopy (BLC) with Hexvix®.|Day 0 (Post contrast administration)|Number of True-positive lesions according to histology was 621 and broken out into various tumor stages. The Tumor stage distribution of true-positive bladder tumor lesions and their detection by White-light Cystoscopy (WLC) and/or Blue-light Cystoscopy (BLC).||Number of lesions|||Number
760313|NCT00634647|Secondary|Toxicity|Here is the number of participants with adverse events. For a detailed of list of adverse events, see the adverse event module.|6/4/08/ to 4/1/12|||Participants|||Number
760314|NCT00634647|Primary|Progression Free Survival.|Time between the start of therapy and progression. Progression is defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Progressive Disease is at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|15 months|21 out of 24 participants was analyzed because three patients were taken off study before progression.||Months||95% Confidence Interval|Median
760315|NCT00634751|Secondary|Overall Survival|Overall survival, defined as number of days from the day of first study drug administration to the day the patient dies, summarized using point estimates of the median time to progression, and associated 95% confidence intervals|Up to 18 months|Overall survival was not a pre-specified Phase I outcome, and no data was collected or analyzed. No data was collected for Phase II biliary tract participants.||Months||95% Confidence Interval|Median
760316|NCT00634751|Secondary|Progression-free Survival (PFS)|Time to progression, defined as number of days from day of first study drug administration to the day the patient experiences an event of disease progression or death; summarized using point estimates of the median time to progression and associated 95% confidence intervals for each stratum separately.|Up to 18 months|PFS was not a pre-specified Phase I outcome, and no data was collected or analyzed. No data was collected for Phase II biliary tract participants.||Months||95% Confidence Interval|Median
760317|NCT00634751|Primary|Overall Response Rate|Response rate of participant to treatment|Up to 18 months|||participants|||Number
760318|NCT00625131|Secondary|Smoking Craving|"Mean smoking craving score (as measured during daily ecological momentary, or diary, assessments) for participants by group during the two week period of placebo/active pre-treatment. This is the main period of interest, as it was hypothesized that use of active nicotine patch would reduce smoking cravings during the pre-quit period. The craving score is based on a single diary item Please rate your desire to smoke right now with a Likert scale score ranging from 1 (none) to 5 (severe). Higher craving is worse, as lower craving is presumed to reflect decreased risk of smoking lapse or relapse."|Daily between visits 2-12|||units on a scale||Standard Deviation|Mean
760319|NCT00625131|Secondary|Carbon Monoxide Monitoring|Number of participants whose carbon monoxide (CO) measurement indicated abstinence at Session 12 (6 weeks post-treatment)|Session 12 (6 weeks post-treatment)|Please note that this secondary outcome (bioverification by CO reading) is not a measure of complete smoking abstinence during the study period (or during the week prior to the session - see Primary Outcome). It is independent of self-reported smoking abstinence. It is not unexpected that CO readings different than self-reported smoking.||participants|||Number
760320|NCT00625131|Primary|Smoking Abstinence, Self-reported|Number of participants by group reporting 1 week of self-reported abstinence in the week prior to Session 12 at six weeks post-treatment|Week prior to Session 12 at 6 weeks post-treatment|Any participants who did not attend Session 12 for any reason (i.e., lost to contact, withdrawn after beginning treatment) were counted as smoking (i.e., intent-to-treat analyses, missing = smoking).||participants|||Number
760321|NCT00625183|Secondary|Distant Relapse Rate||For up to 5 years following surgery.|Due to the study's early termination, as a result of low accrual, target accrual was not reached and no statistical inference of the primary and secondary aims were carried forth.|||||
760322|NCT00625183|Secondary|Local Relapse Rate||For up to 5 years following surgery.|Due to the study's early termination, as a result of low accrual, target accrual was not reached and no statistical inference of the primary and secondary aims were carried forth.|||||
760323|NCT00625183|Secondary|Dose Intensity||During treatment with capecitabine, oxaliplatin, selenomethionine.||||||
760324|NCT00625183|Secondary|Safety and Tolerability as Assessed by NCI CTCAE Version 3.0||Adverse events were queried for and collected every cycle for the duration of treatment.||||||
760325|NCT00625183|Primary|Rate of T-downstaging With Capecitabine, Oxaliplatin, Selenomethionine, and Radiotherapy||After completion of capecitabine, oxaliplatin, selenomethionine, and radiation, and before surgery. Assessed endoscopically.|Due to the study's early termination, as a result of low accrual, target accrual was not reached and no statistical inference of the primary and secondary aims were carried forth.|||||
760326|NCT00625183|Primary|Complete Pathological Response Rate||After completion of capecitabine, oxaliplatin, selenomethionine, and radiation, and before surgery. Assessed endoscopically.|Due to the study's early termination, as a result of low accrual, target accrual was not reached and no statistical inference of the primary and secondary aims were carried forth.|||||
760327|NCT00625365|Secondary|Adverse Events|Summary of the number and percentage of participants with adverse events occuring following completion of DEFINITY administration|Through 24 hours|||Participants|||Number
760328|NCT00625365|Secondary|Serious Adverse Events|Summary of the number and percentage of participants with serious adverse events occuring following completion of DEFINITY administration|Through 24 hours|||Participants|||Number
760329|NCT00625365|Primary|The Number and Percentage of Patients With Death or Life Threatening Cardiopulmonary Events Occurring Following Definity Administration||during or within 30 minutes of administration|The safety population was analyzed per the protocol||Participants|||Number
760344|NCT00625586|Primary|Proportion of Patients Alive at 8 Months||8 months|Study was terminated after 2 patients enrolled therefore no statistical analyses were performed.|||||
760345|NCT00625586|Secondary|Cmax|RAV12 and gemcitabine cmax|29 days||||||
760346|NCT00625586|Secondary|Adverse Events|Frequency of adverse events and serious adverse events|any timeframe following study drug up to 3 years||||||
760347|NCT00625586|Secondary|Overall Survival||three years|Study was terminated after 2 patients enrolled therefore no statistical analyses were performed.|||||
760348|NCT00625586|Secondary|Progression-free Survival||time to progression or death, up to 3 years|Study was terminated after 2 patients enrolled therefore no statistical analyses were performed.|||||
760349|NCT00625586|Secondary|Partial Response and Complete Response Rates|Based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.0; partial response = 30% decrease in sum of longest diameter. complete response = 100% decrease in sum of longest diameter. Rate of response = proportion of complete or partial responses based on number of patients evaluated.|8 months|Study was terminated after 2 patients enrolled therefore no statistical analyses were performed.|||||
760350|NCT00625586|Secondary|Proportion of Patients Alive at 12 Months||12 months||||||
760351|NCT00625729|Secondary|Number of Patients With Overall Survival|Number of patients alive at 6 months after treatment.|6 Months|||Participants|||Number
760352|NCT00625729|Secondary|Number of Patients With Adequate Natural Killer Cells Infused|Incidence of donor products that met release criteria in accordance with FDA regulations (Lot Release Criteria for allogeneic, interleukin-2 (IL-2) activated natural killer (NK) cell products (BB-IND 8847) and the NK cell numbers infused (donor NK cell dose 1.5-8.0 x 10^7/kg).|Day 0|||Participants|||Number
760353|NCT00625729|Secondary|Number of Patients Whose Disease Progressed After Treatment|Includes patients (with non-Hodgkin leukemia or chronic lymphocytic leukemia) whose disease progressed after treatment.|6 Months|Only patients who responded to treatment included in the analysis.||Participants|||Number
760354|NCT00625729|Secondary|Number of Patients With Overall Response|Overall response (complete remission plus partial remission) rate at 3 months, as defined by International Working Group for non-Hodgkin lymphoma and NCI Working Group guidelines for chronic lymphocytic leukemia|3 Months|||Participants|||Number
760355|NCT00625729|Secondary|Number of Patients With Interleukin-15 Production and NK Cell Expansion|Correlation of interleukin-15 production at day 0 with natural killer (NK) cells expansion|Day 0|Correlation of interleukin-15 with Natural Killer Cell expansion cannot be calculated because there was no Natural Killer Cell expansion.||Participants|||Number
760356|NCT00625729|Primary|Number of Patients Exhibiting Natural Killer Cell Expansion|Successful natural killer (NK) cell expansion will be defined as an absolute circulating donor-derived NK cell count of >100 cells/μl 14 days after infusion with <5% donor T and B cells in the mononuclear population.|Day 14|||Participants|||Number
760357|NCT00625742|Secondary|Improvement of Clinical Outcomes|Improvement of clinical outcomes such as strength and function between baseline and day 29 (+/- 3 days).|Baseline to Day 29, approximately 30 days|Only 3 patients completed the study and were evaluable for analysis, others were unable to follow the study exercise and intervention elements. There were insufficient data points collected to analyze.|||||
760358|NCT00625742|Primary|Participant Gain in Lean Body Mass|Measure increases in lean body mass in individuals with cancer who experience cachexia between baseline and day 29 (+/- 3 days).|Baseline to Day 29, approximately 30 days|Only 3 patients completed the study and were evaluable for analysis, others were unable to follow the study exercise and intervention elements. There were insufficient data points collected to analyze.|||||
760359|NCT00625820|Secondary|Estimated Glomerular Filtration Rate (eGFR) Measured at 6 and 12 Weeks of Therapy.||12 weeks|||ml/min/1.73m2||Standard Deviation|Mean
760361|NCT00625820|Primary|The Primary Outcome Measure is Level of Albuminuria.|Early morning urine specimens were collected to calculate albumin and creatinine ratio (albuminuria) at 6 and 12 weeks of therapy.|12 weeks|All participants who finished the trial were analyzed||ratio||Standard Deviation|Mean
760362|NCT00625872|Secondary|Change From Baseline in Skinfold Thickness-Standard Deviation Score (SDS) at Months 12 and 18|Triceps, supra-iliac and subscapular skinfolds were measured on the right side of the body to the nearest 0.1 mm with a Holtain skinfold caliper. The measurement was performed at the left side of the participant. Triceps skinfold thickness was measured halfway down the left upper arm, while the arm was hanging relaxed at the participant's side. Suprascapular skinfold was measured laterally just below the angle of the left scapula. Suprailiac skinfold was measured just above the iliac crest in the middle-axillary line. SDS indicates how similar the participant was to the reference population.|Baseline, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.||mm||Standard Error|Least Squares Mean
760363|NCT00625872|Secondary|Change From Baseline in Skinfold Thickness-Standard Deviation Score (SDS) at Month 6|Triceps, supra-iliac and subscapular skinfolds were measured on the right side of the body to the nearest 0.1 mm with a Holtain skinfold caliper. The measurement was performed at the left side of the participant. Triceps skinfold thickness was measured halfway down the left upper arm, while the arm was hanging relaxed at the participant's side. Suprascapular skinfold was measured laterally just below the angle of the left scapula. Suprailiac skinfold was measured just above the iliac crest in the middle-axillary line. SDS indicates how similar the participant was to the reference population.|Baseline and Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment.||Millimeter (mm)||Standard Error|Least Squares Mean
760364|NCT00625872|Secondary|Change From Baseline in Head Circumference-Standard Deviation Score (SDS) at Months 6, 12 and 18|The maximum head circumference (usually horizontal just above the eyebrow ridges), was measured from just above the glabella area to the area near the top of the occipital bone (opisthocranion). The SDS indicates how similar the participant was to the reference population.|Baseline, Month 6, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.||cm||Standard Deviation|Mean
760365|NCT00625872|Secondary|Change From Baseline in Head Circumference at Months 6, 12 and 18|The maximum head circumference (usually horizontal just above the eyebrow ridges), was measured from just above the glabella area to the area near the top of the occipital bone (opisthocranion).|Baseline, Month 6, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.||cm||Standard Deviation|Mean
760366|NCT00625872|Secondary|Body Mass Index-Standard Deviation Score (BMI-SDS)|The BMI was used to measure body fat based on height and weight. It was calculated by body weight (kg) divided by the height (m) squared. The SDS indicates how similar the participant was to the reference population.|Baseline, Month 6, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.||Kilogram per square meter (kg/m^2)||Standard Deviation|Mean
760367|NCT00625872|Secondary|Sitting Height-Standard Deviation Score (SDS)|Sitting height was measured using a stadiometer with a specialized chair. The SDS indicates how similar the participant was to the reference population.|Baseline, Month 6, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.||cm||Standard Deviation|Mean
760368|NCT00625872|Primary|Change From Baseline in Maximum Jump Velocity (Vmax; Two-leg-jump) in Per Protocol (PP) Population at Month 6|Vmax was measured by Leonardo Jumping Platform during two-leg jump.|Baseline and Month 6|PP population included participants who received the study medication for at least 22 weeks. Number of participants analyzed (N) signifies participants evaluable for the measure.||m/s||Standard Error|Least Squares Mean
760369|NCT00625872|Primary|Change From Baseline in Maximum Jump Velocity (Vmax; Two-leg-jump) in Full Analysis Set (FAS) Population at Month 6|Vmax was measured by Leonardo Jumping Platform during two-leg jump.|Baseline and Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment. Number of participants analyzed (N) signifies participants evaluable for the measure.||Meter/second (m/s)||Standard Error|Least Squares Mean
760370|NCT00625872|Primary|Change From Baseline in Peak Jump Force Standard Deviation Score (PJF-SDS; Two-leg-jump) in Per Protocol (PP) Population at Month 6|PJF was defined as the maximum of force of the ascending part of the jump which the participant performed as a counter-movement jump with freely moving arms and as high as possible with the head and chest. It was measured by Leonardo Jumping Platform during two-leg jump. The SDS indicates how similar the participant was to the reference population.|Baseline and Month 6|PP population included participants who received the study medication for at least 22 weeks. Number of participants analyzed (N) signifies participants evaluable for the measure.||Newtons||Standard Error|Least Squares Mean
760371|NCT00625872|Secondary|Change From Baseline in Growth Velocity-Standard Deviation Score (SDS) at Months 12 and 18|Growth velocity measures the annual rate of increase in height. The SDS indicates how similar the participant is to the reference population.|Baseline, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.||cm/year||Standard Error|Least Squares Mean
760372|NCT00625872|Secondary|Change From Baseline in Growth Velocity-Standard Deviation Score (SDS) at Month 6|Growth velocity measures the annual rate of increase in height. The SDS indicates how similar the participant is to the reference population.|Baseline and Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment. Number of participants analyzed (N) signifies participants evaluable for the measure.||cm/year||Standard Error|Least Squares Mean
760373|NCT00625872|Secondary|Change From Baseline in Height-Standard Deviation Score (SDS) at Months 12 and 18|Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer. The SDS indicates how similar the participant was to the reference population.|Baseline, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.||cm||Standard Error|Least Squares Mean
760420|NCT00625989|Primary|The Primary Outcome Measure for This Study is the Number of Sputum Myeloid Dendritic Cells|Flow-cytometric acquisitions were used to determine the percentage of each type of mononuclear cell. These percentages were multiplied by the number of sputum mononuclear cells calculated by using total and differential cell counts of the sputum sample.|24 hrs|||number of cells/g of sputum||Standard Deviation|Mean
760374|NCT00625872|Secondary|Change From Baseline in Height-Standard Deviation Score (SDS) at Month 6|Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer. The SDS indicates how similar the participant was to the reference population.|Baseline and Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment.||cm||Standard Error|Least Squares Mean
760375|NCT00625872|Secondary|Mean Growth Velocity-Standard Deviation Score (SDS) at Months 12 and 18||Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.||cm/year||Standard Deviation|Mean
760376|NCT00625872|Secondary|Mean Growth Velocity-Standard Deviation Score (SDS) at Month 6|Growth velocity measures the annual rate of increase in height. The SDS indicates how similar the participant is to the reference population.|Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment.||cm/year||Standard Deviation|Mean
760377|NCT00625872|Secondary|Mean Height-Standard Deviation Score (SDS) at Months 12 and 18|Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer. The SDS indicates how similar the participant was to the reference population.|Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.||cm||Standard Deviation|Mean
760378|NCT00625872|Secondary|Mean Height-Standard Deviation Score (SDS) at Month 6|Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer. The SDS indicates how similar the participant was to the reference population.|Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment.||cm||Standard Deviation|Mean
760379|NCT00625872|Secondary|Mean Growth Velocity at Months 12 and 18|Growth velocity measures the annual rate of increase in height.|Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.||cm/year||Standard Deviation|Mean
760380|NCT00625872|Secondary|Mean Growth Velocity at Month 6|Growth velocity measures the annual rate of increase in height.|Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment.||cm/year||Standard Deviation|Mean
760381|NCT00625872|Secondary|Mean Height at Months 12 and 18|Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer.|Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.||cm||Standard Deviation|Mean
760382|NCT00625872|Secondary|Mean Height at Month 6|Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer.|Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment.||cm||Standard Deviation|Mean
760383|NCT00625872|Secondary|Mean Calf Circumference|Calf measurements were taken as a mean of 3 consecutive measurements at largest part of calf muscle, usually about 4 inches down from below the knee.|Baseline, Month 6, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.||cm||Standard Deviation|Mean
760384|NCT00625872|Secondary|Mean Thigh Circumference|Thigh measurements were taken as a mean of 3 consecutive measurements at upper thigh about an inch down from the crotch line.|Baseline, Month 6, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.||cm||Standard Deviation|Mean
760385|NCT00625872|Secondary|Mean Upper Arm Circumference||Baseline, Month 6, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.||centimeter (cm)||Standard Deviation|Mean
760386|NCT00625872|Other Pre-specified|Change From Baseline in Bone Stability Using Peripheral Quantitative Computed Tomography (pqCT) at 6 or 12 or 18 Months|Bone stability was measured by pqCT. Baseline and post-baseline SDS values transformed to age and sex specific z-score (Ln(test result/M)]/S); Ln=natural logarithm; M=age- (or height-) and sex-specific mean value; S=age-(or height-) and sex-specific coefficient of variation) then change from baseline is calculated. Positive values are above the average for participant’s age and sex; negative values are below the average.|Baseline, Month 6, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.||z-score||Standard Error|Least Squares Mean
760387|NCT00625872|Other Pre-specified|Change From Baseline in Bone Structure Using Peripheral Quantitative Computed Tomography (pqCT) at 6 or 12 or 18 Months|Bone structure was measured by pqCT.Parameters included:total area,cortical area,marrow area,cortical thickness,cortical density of the radius,bone strength,cross-sectional muscle and fat area,total bone density,bone mineral count,trabecular BMD,bone cross-sectional area.Baseline and post-baseline SDS values transformed to age and sex specific z-score([Ln(test result/M)]/S);Ln=natural logarithm;M=age-/height- and sex-specific mean value;S=age-/height- and sex-specific coefficient of variation).Positive values are above the average for participant’s age and sex;negative values are below.|Baseline, Month 6, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.||z-score||Standard Error|Least Squares Mean
760388|NCT00625872|Other Pre-specified|Change From Baseline in Bone Density Using Peripheral Quantitative Computed Tomography (pqCT) at 6 or 12 or 18 Months|Bone Mineral Density (BMD) was measured by pqCT. The Z-score measures the distance of the measured BMD value from the appropriate normal age matched population mean value in units of standard deviation of this population. More negative scores indicate less BMD compared to age matched population and more positive scores indicate higher BMD compared to age matched population.|Baseline, Month 6, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.||z-score||Standard Error|Least Squares Mean
760389|NCT00625872|Secondary|Change From Baseline in Maximal Isometric Grip Force-Standard Deviation Score (MIGF-SDS) at Months 12 and 18|MIGF was assessed using standard adjustable Jamar dynamometer. MIGF (in Newtons) was calculated by multiplying the dynamometer reading (in kilograms) by a factor of 9.81. The SDS indicates how similar the participant was to the reference population.|Baseline, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.||kg||Standard Error|Least Squares Mean
760421|NCT00626028|Secondary|Surgical Procedures at 3 Years|The 3 year follow-up survival assessment consisted of a telephone call to subjects to obtain information on surgeries received pertaining to pulmonary or cardiac disease|3 years after treatment|||Participants with surgical procedures|||Number
760390|NCT00625872|Secondary|Change From Baseline in Maximal Isometric Grip Force-Standard Deviation Score (MIGF-SDS) at Month 6|MIGF was assessed using standard adjustable Jamar dynamometer. MIGF (in Newtons) was calculated by multiplying the dynamometer reading (in kilograms) by a factor of 9.81. The SDS indicates how similar the participant was to the reference population.|Baseline and Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment. Number of participants analyzed (N) signifies participants evaluable for the measure.||kg||Standard Error|Least Squares Mean
760391|NCT00625872|Secondary|Change From Baseline in One-chair Rising Test (Time to Perform the Tasks) at Months 6, 12 and 18|The Chair rising test is a performance test (total power output) to measure neuromuscular function of complex movement to stand up. Test allows diagnostics of movement deficits using Leonardo jump plate. One stand up test: rising from a chair on the jump plate as quickly as possible with arms crossed over the chest (analysis of time, PJP, PJF and time of fastest rising).|Baseline, Month 6 , Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.||seconds||Standard Deviation|Mean
760392|NCT00625872|Secondary|Change From Baseline in One-chair Rising Test-Peak Jump Force (PJF) at Months 6, 12 and 18|The Chair rising test is a performance test (total power output) to measure neuromuscular function of complex movement to stand up. Test allows diagnostics of movement deficits using Leonardo jump plate. One stand up test: rising from a chair on the jump plate as quickly as possible with arms crossed over the chest (analysis of time, PJP, PJF and time of fastest rising). PJF is the maximum force of the ascending part of the jump which the participant performed as a counter-movement jump with freely moving arms as high as possible with the head and chest.|Baseline, Month 6 , Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.||kN||Standard Deviation|Mean
760393|NCT00625872|Secondary|Change From Baseline in One-chair Rising Test-Peak Jump Power (PJP) at Months 6, 12 and 18|The Chair rising test is a performance test (total power output) to measure neuromuscular function of complex movement to stand up. Test allows diagnostics of movement deficits using Leonardo jump plate. One stand up test: rising from a chair on the jump plate as quickly as possible with arms crossed over the chest (analysis of time, PJP, PJF and time of fastest rising). PJP is defined as the peak of the calculated power (force multiplied by velocity).|Baseline, Month 6 , Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.||kW||Standard Deviation|Mean
760394|NCT00625872|Secondary|Change From Baseline in Five-chair Rising Test (Time to Perform the Tasks) at Months 12 and 18|Chair rising test is performance test (total power output) to measure neuromuscular function of complex movement in standing up. Test allows diagnostics of movement deficits using Leonardo jump plate. Five stand up test: 5 repetitions of rising from a chair on jump plate as quickly as possible with arms crossed over chest (time to perform tasks, maximal PJP, maximal velocity and maximal PJF). Time to perform task includes: Average (avg) rise time which is avg time to perform 1 rise, avg time per test is the avg time to perform 1 test (rise and sitting down) and total time to perform 5 tests.|Baseline, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.||seconds||Standard Deviation|Mean
760395|NCT00625872|Secondary|Change From Baseline in Five-chair Rising Test (Time to Perform the Tasks) at Month 6|Chair rising test is performance test (total power output) to measure neuromuscular function of complex movement in standing up. Test allows diagnostics of movement deficits using Leonardo jump plate. Five stand up test: 5 repetitions of rising from a chair on jump plate as quickly as possible with arms crossed over chest (time to perform tasks, maximal PJP, maximal velocity and maximal PJF). Time to perform task includes: Average (avg) rise time which is avg time to perform 1 rise, avg time per test is the avg time to perform 1 test (rise and sitting down) and total time to perform 5 tests.|Baseline and Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment. Number of participants analyzed (N) signifies participants evaluable for the measure.||seconds||Standard Deviation|Mean
760396|NCT00625872|Secondary|Change From Baseline in Five-chair Rising Test-Maximum Jump Velocity (Vmax) at Months 12 and 18|The Chair rising test is a performance test (total power output) to measure neuromuscular function of complex movement in standing up. Test allows diagnostics of movement deficits using Leonardo jump plate. Five stand up test: five repetitions of rising from a chair on jump plate as quickly as possible with arms crossed over the chest (time to perform the tasks, maximal PJP, maximal velocity and maximal PJF). Vmax is defined as the maximum jump velocity.|Baseline, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.||m/s||Standard Deviation|Mean
760397|NCT00625872|Secondary|Change From Baseline in Five-chair Rising Test-Maximum Jump Velocity (Vmax) at Month 6|The Chair rising test is a performance test (total power output) to measure neuromuscular function of complex movement in standing up. Test allows diagnostics of movement deficits using Leonardo jump plate. Five stand up test: five repetitions of rising from a chair on jump plate as quickly as possible with arms crossed over the chest (time to perform the tasks, maximal PJP, maximal velocity and maximal PJF). Vmax is defined as the maximum jump velocity.|Baseline and Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment. Number of participants analyzed (N) signifies participants evaluable for the measure.||m/s||Standard Deviation|Mean
760398|NCT00625872|Secondary|Change From Baseline in Five-chair Rising Test-Peak Jump Force (PJF) at Months 12 and 18|The Chair rising test is a performance test (total power output) to measure neuromuscular function of complex movement in standing up. Test allows diagnostics of movement deficits using Leonardo jump plate. Five stand up test: five repetitions of rising from a chair on jump plate as quickly as possible with arms crossed over the chest (time to perform the tasks, maximal PJP, maximal velocity and maximal PJF). PJF is the maximum force of the ascending part of the jump which the participant performed as a counter-movement jump with freely moving arms as high as possible with the head and chest.|Baseline, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.||kN||Standard Deviation|Mean
760422|NCT00626028|Secondary|Serious Adverse Events||12 hours after discontinuation of gas or dischange (whichever comes first)||||||
760423|NCT00626028|Secondary|Adverse Events||treatment 1 through treatment 3||||||
787453|NCT00844194|Secondary|Suicidal Thoughts by BDI-II at Week 6||Week 6|All patients receiving at least one dose of study medication and having data at week 6.||Participants|||Number
760399|NCT00625872|Secondary|Change From Baseline in Five-chair Rising Test-Peak Jump Force (PJF) at Month 6|The Chair rising test is a performance test (total power output) to measure neuromuscular function of complex movement in standing up. Test allows diagnostics of movement deficits using Leonardo jump plate. Five stand up test: five repetitions of rising from a chair on jump plate as quickly as possible with arms crossed over the chest (time to perform the tasks, maximal PJP, maximal velocity and maximal PJF). PJF is the maximum force of the ascending part of the jump which the participant performed as a counter-movement jump with freely moving arms as high as possible with the head and chest.|Baseline and Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment. Number of participants analyzed (N) signifies participants evaluable for the measure.||kilonewton (kN)||Standard Deviation|Mean
760400|NCT00625872|Secondary|Change From Baseline in Five-chair Rising Test-Peak Jump Power (PJP) at Months 12 and 18|The Chair rising test is a performance test (total power output) to measure neuromuscular function of complex movement in standing up. Test allows diagnostics of movement deficits using Leonardo jump plate. Five stand up test: five repetitions of rising from a chair on jump plate as quickly as possible with arms crossed over the chest (time to perform the tasks, maximal PJP, maximal velocity and maximal PJF). PJP is defined as the peak of the calculated power (force multiplied by velocity).|Baseline, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.||kW||Standard Deviation|Mean
760401|NCT00625872|Secondary|Change From Baseline in Five-chair Rising Test- Peak Jump Power (PJP) at Month 6|The Chair rising test is a performance test (total power output) to measure neuromuscular function of complex movement in standing up. Test allows diagnostics of movement deficits using Leonardo jump plate. Five stand up test: five repetitions of rising from a chair on jump plate as quickly as possible with arms crossed over the chest (time to perform the tasks, maximal PJP, maximal velocity and maximal PJF). PJP is defined as the peak of the calculated power (force multiplied by velocity).|Baseline and Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment. Number of participants analyzed (N) signifies participants evaluable for the measure.||kilowatt (kW)||Standard Deviation|Mean
760402|NCT00625872|Secondary|Change From Baseline in Maximum Jump Velocity (Vmax; One-leg-jump) at Months 6, 12 and 18|Vmax was measured by Leonardo Jumping Platform during one leg jump.|Baseline, Month 6, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.||m/s||Standard Deviation|Mean
760403|NCT00625872|Secondary|Change From Baseline in Peak Jump Force Standard Deviation Score (PJF-SDS; One-leg-jump) at Months 6, 12 and 18|PJF was defined as the maximum of force of the ascending part of the jump which the participant performed as a counter-movement jump with freely moving arms and as high as possible with the head and chest. It was measured by Leonardo Jumping Platform during one leg jump. The SDS indicates how similar the participant was to the reference population.|Baseline, Month 6, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.||Newtons||Standard Deviation|Mean
760404|NCT00625872|Secondary|Change From Baseline in Peak Jump Power Standard Deviation Score (PJP-SDS; One-leg-jump) at Months 6, 12 and 18|PJP was defined as the peak of the calculated power (force multiplied by velocity). It was measured by Leonardo Jumping Platform during one leg jump. The participant performs 3 jumps and the highest peak (PJP) of the 3 recordings was selected for further calculations. The SDS indicates how similar the participant was to the reference population.|Baseline, Month 6 , Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.||W/kg||Standard Deviation|Mean
760405|NCT00625872|Secondary|Change From Baseline in Intellectual Performance of Children Using Child Behavior Checklist 4-18 Years (CBCL 4-18) at Months 6, 12 and 18|CBCL was standardized for children ages 4 to 18 years and measured child internalizing and externalizing behaviors and total problems. The 4-18 years’ checklist contains 140 questions and responses were recorded on a Likert scale: 0 = Not True, 1 = Somewhat or Sometimes True, 2 = Very True or Often True. The range of possible values was 0-280 (0=good to 280=worst).|Baseline, Month 6, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.||Units on a scale||Standard Deviation|Mean
760406|NCT00625872|Secondary|Change From Baseline in Intellectual Performance of Children Using Non-verbal Learning Test (NVLT) at Months 12 and 18|"NVLT was assessed for visual memorization that was difficult to verbalize. Test recorded instability index, T-scores[sum of differences of correct {C} - incorrect {IC} Yes answers(1);sum of C Yes answers(2);sum of IC Yes answers(3);sum of differences of C-IC Yes answers with high associative items{ 87%-95%}(4);sum of differences of C-IC Yes answers with low associative items{ 54%-64%}(5); difference between difference values for high and low associative items(6)].Scores were rated as below average(<40), average(40-60), above average(>60) and working time ranging between 9-12 minutes."|Baseline, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.||Units on a scale||Standard Deviation|Mean
760407|NCT00625872|Secondary|Change From Baseline in Intellectual Performance of Children Using Non-verbal Learning Test (NVLT) at Month 6|"NVLT was assessed for visual memorization that was difficult to verbalize. Test recorded instability index, T-scores[sum of differences of correct {C} - incorrect {IC} Yes answers(1);sum of C Yes answers(2);sum of IC Yes answers(3);sum of differences of C-IC Yes answers with high associative items{ 87%-95%}(4);sum of differences of C-IC Yes answers with low associative items{ 54%-64%}(5); difference between difference values for high and low associative items(6)].Scores were rated as below average(<40), average(40-60), above average(>60) and working time ranging between 9-12 minutes."|Baseline and Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment. Number of participants analyzed (N) signifies participants evaluable for the measure.||Units on a scale||Standard Deviation|Mean
760424|NCT00626028|Secondary|Surgical Procedures at 1 Year|The 1 year follow-up survival assessment consisted of a telephone call to subjects to obtain information on surgeries received pertaining to pulmonary or cardiac disease|1 year after treatment|||Participants with surgical procedures|||Number
760482|NCT00626561|Primary|Progression-free Survival (PFS)|Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.|Baseline to 6 Months, or until disease progression.|Interim analysis was to be done after 10 patients enrolled, accrual not met. Study halted early.|||||
760408|NCT00625872|Secondary|Change From Baseline in Intellectual Performance of Children Using Kinderversion Der Testbatterie Zur Aufmerksamkeitsprüfung für Kinder (KITAP) Test at Months 12 and 18|"The KITAP is a computer aided standardized neuro-cognitive development test which allows examination of a wide range of attention and executive functions such as shift of attention (Distractibility); simple reaction time (Alertness); Sustained Attention, change of reaction (Flexibility); Divided Attention, controlled reaction disposition (Go/No go) and Vigilance. It has been designed appropriately for children between the age of 6 to 10 years to allow optimal motivation during testing and to increase validity of results."|Baseline, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.||Seconds||Standard Deviation|Mean
760409|NCT00625872|Secondary|Change From Baseline in Intellectual Performance of Children Using Kinderversion Der Testbatterie Zur Aufmerksamkeitsprüfung für Kinder (KITAP) Test at Month 6|"The KITAP is a computer aided standardized neuro-cognitive development test which allows examination of a wide range of attention and executive functions such as shift of attention (Distractibility); simple reaction time (Alertness); Sustained Attention, change of reaction (Flexibility); Divided Attention, controlled reaction disposition (Go/No go) and Vigilance. It has been designed appropriately for children between the age of 6 to 10 years to allow optimal motivation during testing and to increase validity of results."|Baseline and Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment. Number of participants analyzed (N) signifies participants evaluable for the measure and 'n' signifies participants who received the study drug and evaluated at the time point for each group respectively.||Seconds||Standard Deviation|Mean
760410|NCT00625872|Secondary|Change From Baseline in Intellectual Performance of Children Using Kaufmann-Assessment Battery for Children (K-ABC) Test Global Scales at Months 12 and 18|K-ABC was assessed in children between 2.5-12.5 years. Comprised of 16 subtests; 10 mental processing (intelligence) and 6 achievement subtests. Achievement subtests: expressive vocabulary, faces&places, arithmetic, riddles, reading/decoding, reading/comprehension. Sixteen subtests were weighted accordingly to form 5 global scales: sequential processing, simultaneous processing, achievement, non-verbal and mental processing composite. Scores were rated as upper extreme [greater than (>) 131], above average (116-130), average (85-115), below average (70-84), lower extreme [less than (<) 69].|Baseline, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.||Units on a scale||Standard Deviation|Mean
760411|NCT00625872|Secondary|Change From Baseline in Intellectual Performance of Children Using Kaufmann-Assessment Battery for Children (K-ABC) Test Global Scales at Month 6|K-ABC was assessed in children between 2.5-12.5 years. Comprised of 16 subtests; 10 mental processing (intelligence) and 6 achievement subtests. Achievement subtests: expressive vocabulary, faces&places, arithmetic, riddles, reading/decoding, reading/comprehension. Sixteen subtests were weighted accordingly to form 5 global scales: sequential processing, simultaneous processing, achievement, non-verbal and mental processing composite. Scores were rated as upper extreme [greater than (>) 131], above average (116-130), average (85-115), below average (70-84), lower extreme [less than (<) 69].|Baseline and Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
760412|NCT00625872|Primary|Change From Baseline in Peak Jump Force Standard Deviation Score (PJF-SDS; Two-leg-jump) in Full Analysis Set (FAS) Population at Month 6|PJF was defined as the maximum of force of the ascending part of the jump which the participant performed as a counter-movement jump with freely moving arms and as high as possible with the head and chest. It was measured by Leonardo Jumping Platform during two-leg jump. The SDS indicates how similar the participant was to the reference population.|Baseline and Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment. Number of participants analyzed (N) signifies participants evaluable for the measure.||Newtons||Standard Error|Least Squares Mean
760413|NCT00625872|Primary|Change From Baseline in Peak Jump Power Standard Deviation Score (PJP-SDS; Two-leg-jump) in Per Protocol (PP) Population at Month 6|PJP was defined as the peak of the calculated power (force multiplied by velocity). It was measured by Leonardo Jumping Platform during two-leg jump. The participant performs 3 jumps and the highest peak (PJP) of the 3 recordings was selected for further calculations. The SDS indicates how similar the participant was to the reference population.|Baseline and Month 6|PP population included participants who received the study medication for at least 22 weeks. Number of participants analyzed (N) signifies participants evaluable for the measure.||W/kg||Standard Error|Least Squares Mean
760414|NCT00625872|Primary|Change From Baseline in Peak Jump Power Standard Deviation Score (PJP-SDS; Two-leg-jump) in Full Analysis Set (FAS) Population at Month 6|Peak jump power (PJP) was defined as the peak of the calculated power (force multiplied by velocity). It was measured by Leonardo Jumping Platform during two-leg jump. The participant performs 3 jumps and the highest peak (PJP) of the 3 recordings was selected for further calculations. The SDS indicates how similar the participant was to the reference population.|Baseline and Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment. Number of participants analyzed (N) signifies participants evaluable for the measure.||Watt/kilogram (W/kg)||Standard Error|Least Squares Mean
760415|NCT00625989|Secondary|The Secondary Outcome Measure is the Level of Specific Chemokines Released in the Sputum Supernatant||72 hrs||||||
760416|NCT00625989|Secondary|The Secondary Outcome Measure is the Level of Specific Chemokines Released in the Sputum Supernatant||24 hrs||||||
760417|NCT00625989|Secondary|The Secondary Outcome Measure is the Level of Specific Chemokines Released in the Sputum Supernatant||7 hrs||||||
760418|NCT00625989|Secondary|The Secondary Outcome Measure is the Level of Specific Chemokines Released in the Sputum Supernatant.||Before inhalation (0hrs)||||||
760419|NCT00625989|Primary|The Primary Outcome Measure for This Study is the Number of Sputum Plasmacytoid Dendritic Cells|Flow-cytometric acquisitions were used to determine the percentage of each type of mononuclear cell. These percentages were multiplied by the number of sputum mononuclear cells calculated by using total and differential cell counts of the sputum sample.|24 hrs|||number of cells/g of sputum||Standard Deviation|Mean
761424|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Vital Capacity (VC)||Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)||Percentage||Standard Deviation|Mean
760425|NCT00626028|Primary|Reversible Pulmonary Hypertension (Vasoreactivity)as Defined by Hemodynamic Measurements|Hemodynamic measurements (heart rate, systolic arterial blood pressure,diastolic arterial blood pressure, mean arterial pressure, mean central venous pressure, systolic pulmonary arterial pressure, diastolic pulmonary arterial pressure, mean pulmonary wedge pressure and cardiac output) were used to measure reversible pulmonary hypertension (vasoreactivity).|1 year|One hundred thirty six participants were enrolled (intent-to-treat population), 124 received study drug.||Participants|||Number
760426|NCT00626093|Secondary|Defibrillation Threshold Difference Obtained in Joules (J)||Baseline and 6 months|||Joules||Standard Deviation|Mean
760427|NCT00626093|Primary|Defibrillation Threshold Difference Obtained in Volts (V) Between Implant and 6 Months|All patients underwent defibrillation threshold testing at cardiac resynchronization therapy-defibrillator (CRT-D) implant and then at 6 months. The outcome measure is the difference in DFT (defibrillation threshold) in volts between implant and 6 months.|Baseline and 6 months|||Volts||Standard Deviation|Mean
760428|NCT00626210|Secondary|Improvement of Daytime Alertness and Quality of Life.||~1 month||||||
760429|NCT00626210|Primary|Nocturnal Sleep Length at 1 Month||1 month|||hours||Full Range|Median
760430|NCT00626275|Primary|"Part B: The Mean of Daily Average Now Lower Extremity Pain Intensity (LEPI) Score During the 2-Week Period"|"Participants assessed their “Now” LEPI 3 times each day (morning, midday, and evening at approximately 10 AM, 2 PM, and 8 PM) and before taking any rescue medication. At each time point, participants were asked to rate their lower extremity pain on an 11-point Numeric Pain Rating Scale (NPRS), with 0 indicating No Pain and 10 indicating Worst Possible Pain. If a scheduled pain assessment was taken within 4 hours of rescue medication, the observed pain score was replaced by the pain score obtained right before the rescue medication was taken.
LS means and SE were calculated from an analysis-of-covariance model with effect for treatment and baseline “Now” LEPI (before dosing for Treatment Period 1 of Part A) as a covariate. Participants with no postbaseline assessments were excluded from the baseline summary."|Baseline through 2 Weeks|Participants in Part B who received at least 1 dose of study drug and had at least 1 pain intensity assessment post dose.||units on a scale||Standard Error|Least Squares Mean
760431|NCT00626275|Secondary|Part A: Participant’s Global Evaluation of Study Medication|For each treatment period during Part A, each participant’s global evaluation (overall impression) of study medication was obtained 6 hours after dosing. Scores were recorded on the Case Report Form (CRF) on a 5 point scale ranging from “excellent” to “poor”. Participant counts per score were reported once in Part A.|6 hours post dose during Treatment Periods 1, 2, and 3 of Part A|Participants in Part A who received at least 1 dose of study drug and had at least 1 pain intensity assessment post dose.||participants|||Number
760432|NCT00626275|Secondary|Part B: Percentage of Participants Using Rescue Medication|The percentage of participants who took at least 1 dose of rescue medication during 2-week treatment period of Part B is presented.|Baseline through Week 2|Participants in Part B who received at least 1 dose of study drug and had at least 1 pain intensity assessment post dose.||Percentage of Participants|||Number
760433|NCT00626275|Secondary|Part B: Mean Daily Average Overall Pain Intensity Scores Over Week 1, Over Week 2, and Over a 2-Week Period|During Part B, participants returned to the clinic for 2 additional visits at approximately weekly intervals for assessments of Overall Pain Index (OPI). Participants rated their OPI on an 11-point Numeric Pain Rating Scale (NPRS) with 0 indicating No Pain and 10 indicating Worst possible pain|Baseline through Week 1, Week 1 through Week 2, and Baseline through Week 2|Participants in Part B who received at least 1 dose of study drug and had at least 1 pain intensity assessment post dose.||units on a scale||Standard Deviation|Mean
760434|NCT00626275|Secondary|Part B: Mean Daily Average LEPI Scores Over the Last 24 Hours at Week 1 and Week 2|Each day during Part B, participants rated their Lower Extremity Pain Intensity over the last 24 hours on an 11-point NPRS, with 0 indicating No Pain and 10 indicating Worst Possible Pain|Week 1 and Week 2|Participants in Part B who received at least 1 dose of study drug and had at least 1 pain intensity assessment post dose.||units on a scale||Standard Deviation|Mean
760435|NCT00626275|Secondary|Part B: Participants’ Global Evaluation of Study Medication|For Part B, each participant’s global evaluation (overall impression) of study medication was obtained at each weekly visit. Scores were recorded on the Case Report Form (CRF) on a 5 point scale ranging from “excellent” to “poor”. Participant counts per score were reported at Week 1 (Day 7) and Week 2 (Day 14).|Up to Week 1 and Week 2|Participants in Part B who received at least 1 dose of study drug and had at least 1 pain intensity assessment post dose.||Participants|||Number
760436|NCT00626275|Secondary|Part A: Percentage of Participants in Each Treatment Group Achieving a 25%, 50%, or 75% Reduction From Baseline in Evoked Lower Extremity Pain Intensity Scores|Percentage was measured by identifying the number of participants who achieved the desired percentage Reduction From Baseline in ELEPI Score at either 2, 4, and 6 hours post dose and was divided the by the number of total participants in the given group and then multiplied by 100 to equate to a percentage.|Up to 2, 4, and 6 hours post dosing|Participants in Part A who received at least 1 dose of study drug and had at least 1 pain intensity assessment post dose.||Percentage of Participants|||Number
760437|NCT00626275|Secondary|Part A: Mean Peak Difference in ELEPI According to the NPRS Scale|Evoked Lower Extremity Pain Intensity (ELEPI) was assessed using the 11-point NPRS. Participants were asked to rate their lower extremity pain on an 11 point NPRS, with 0 indicating No Pain and 10 indicating Worst Possible Pain. If a scheduled pain assessment was taken within 4 hours of rescue medication, the observed pain score was replaced by the pain score obtained right before the rescue medication was taken. Approximately 1 hour before dosing and approximately 45 minutes before the 2-, 4-, and 6-hour time points, the participant rested for 45 minutes, then he or she started a treadmill walk at 15 minutes before dosing for baseline and at the 2-, 4-, and 6-hour time points, and then assessed ELEPI. Peak ELEPID was defined as the maximum of ELEPIDs recorded at 2, 4, and 6 hours post dose. Difference = predose (baseline) NPRS score - peak NPRS score up to 6 hours post dose.|Baseline, Up to 6 hours post dose|Participants in Part A who received at least 1 dose of study drug and had at least 1 pain intensity assessment post dose.||units on a scale||Standard Deviation|Mean
760483|NCT00626574|Secondary|To Determine the Feasibility of Organizing a Larger, Randomized Study to Explore the Neuroprotective Effect of Procrit® in Patients With Aneurysmal SubArachnoid Hemorrhage (SAH) When Procrit® is Administered Prior to Surgical Clipping of the Aneurysm.||When all data is collected and analyzed||||||
760438|NCT00626275|Secondary|Part A: Average Difference Between Baseline and Postdose Evoked Lower Extremity Pain Over the 4 Hours After Dosing|Evoked Lower Extremity Pain Intensity (ELEPI) was assessed using the 11-point Numeric Pain Rating Scale (NPRS), with 0 indicating No Pain and 10 indicating Worst Possible Pain. Approximately 1 hour before dosing and approximately 45 minutes before the 2-, 4-, and 6-hour time points, the participant rested for 45 minutes, then he or she started a treadmill walk at 15 minutes before dosing for baseline and at the 2-, 4-, and 6-hour time points, and then assessed ELEPI. Difference = predose (baseline) ELEPI score - ELEPI score 4 hours post dose.|Baseline, 4 hours post dose|Participants in Part A who received at least 1 dose of study drug and had at least 1 pain intensity assessment post dose||units on a scale||Standard Deviation|Mean
760439|NCT00626275|Secondary|Part A: Pain Intensity Difference Between Baseline and the Value at Each Scheduled Time Point for Overall Pain|Overall Pain Intensity (OPI) was assessed by the participant using the 11-point Numeric Pain Rating Scale (NPRS), with 0 indicating No Pain and 10 indicating Worst Possible Pain. OPI was assessed at 15 minutes before dosing for baseline and at 6 and 12 hours after dosing. Difference = predose (baseline) OPI score - OPI score 6 and 12 hours post dose.|Baseline, 6 and 12 hours post dose|Participants in Part A who received at least 1 dose of study drug and had at least 1 pain intensity assessment post dose.||units on a scale||Standard Deviation|Mean
760440|NCT00626275|Secondary|Part B: Mean Daily LEPI Scores for Weeks 1 and 2|Participants assessed their “Now” LEPI 3 times each day (morning, midday, and evening at approximately 10 AM, 2 PM, and 8 PM) and before taking any rescue medication. At each time point, participants were asked to rate their lower extremity pain on an 11 point Numeric Pain Rating Scale (NPRS), with 0 indicating No Pain and 10 indicating Worst Possible Pain. If a scheduled pain assessment was taken within 4 hours of rescue medication, the observed pain score was replaced by the pain score obtained right before the rescue medication was taken.|Baseline through Week 1 and Week 1 through Week 2|Participants in Part B who received at least 1 dose of study drug and had at least 1 pain intensity assessment post dose.||units on a scale||Standard Deviation|Mean
760441|NCT00626275|Secondary|Part A: Pain Intensity Score (NPRS Score) for Overall Pain, for Lower Extremity Pain, and for Evoked (by Treadmill Walking) Lower Extremity Pain|Overall Pain Intensity (OPI), “Now” Lower Extremity Pain Intensity (LEPI), and Evoked Lower Extremity Pain Intensity (ELEPI) were assessed using the 11-point Numeric Pain Rating Scale (NPRS), with 0 indicating No Pain and 10 indicating Worst Possible Pain. OPI was assessed at 15 minutes before dosing for baseline and at 6 and 12 hours (hr) after dosing. At 15 minutes before dosing, during Period 1 only, participants were also asked to assess their average LEPI over the last 24 hours as a baseline measurement. “Now” LEPI was assessed at 15 minutes before dosing for baseline and at the 1-, 2-, 3-, 4-, 5-, 6-, and 12-hour time points. Approximately 1 hour before dosing and approximately 45 minutes before the 2-, 4-, and 6-hour time points, the participant rested for 45 minutes, then (after the “Now” LEPI assessment) he or she started a treadmill walk at 15 minutes before dosing for baseline and at the 2-, 4-, and 6-hour time points, and then assessed ELEPI.|Baseline up to 12 hours post dose|Participants in Part A who received at least 1 dose of study drug and had at least 1 pain intensity assessment post dose.||units on a scale||Standard Deviation|Mean
760442|NCT00626275|Primary|Part A: Average Difference Between Baseline and Post Dose Evoked (by Treadmill Walking) Lower-Extremity Pain Intensity Scores (AELEPID) Over the 6 Hours After Dosing|"Approximately 1 hour before baseline and again approximately 45 minutes before the 2-, 4-, and 6-hour time points, participants rested for 45 minutes, then they started the treadmill walk at 15 minutes before baseline and at the 2-, 4-, and 6-hour time points. After the treadmill walk, participants were asked to rate their lower extremity pain on an 11 point Numeric Pain Rating Scale (NPRS), with 0 indicating No Pain and 10 indicating Worst Possible Pain. The average difference between baseline and 6 hours post dose evoked lower-extremity pain intensity scores (AELEPID-6) is presented for each treatment group. Difference = predose (baseline) NPRS score - NPRS score 6 hours post dose.
Least square (LS) means and standard errors (SE) were calculated from an analysis-of-covariance (ANCOVA) model with fixed effects for sequence, treatment, period, predose evoked lower extremity pain intensity as a covariate, and a random effect for participant nested within sequence."|Baseline through 6 hours post dose|Participants in Part A who received at least 1 dose of study drug and had at least 1 pain intensity assessment post dose.||units on a scale||Standard Error|Least Squares Mean
760443|NCT00626327|Secondary|Number of Subjects Reporting Unsolicited Adverse Events After Vaccination|The safety profile of MenACWY-CRM and MMRV vaccines when given concomitantly as compared to when MenACWY-CRM or MMRV was given alone is reported in terms of number of subjects reporting unsolicited adverse events (AEs), medically significant adverse events and serious adverse events (SAEs) after vaccination.|Day 1- Day 180 (Through out the study)|This analysis was done on the safety set population||Participants|||Number
760444|NCT00626327|Secondary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination|"Safety and tolerability of MenACWY-CRM and MMRV vaccines when given concomitantly compared to when either MenACWY-CRM or MMRV vaccine was administered alone is reported in terms of the number of subjects with local and systemic adverse events after vaccination.
Systemic reactions including axillary temperature reported during 28 days after vaccination at 12 months of age. These included the following systemic reactions: Measles-like rash, Rubella-like rash, Varicellalike rash, injection site rash, Mumps-like symptoms and axillary temperature."|upto 7 days after any vaccination|The analysis was performed on the safety set population||Participants|||Number
760445|NCT00626327|Secondary|Geometric Mean Titers After One Dose of MenACWY-CRM Vaccine|The immunogenicity of one dose of MenACWY-CRM vaccine given at 7 to 9 months of age was assessed in terms of GMTs directed against N.meningitidis serogroups A, C, W-135, and Y.|1 month post vaccine dose 1|The analysis was performed on the MenACWY per-protocol population||Titers||95% Confidence Interval|Geometric Mean
760446|NCT00626327|Secondary|Percentages of Subjects With hSBA ≥1:4 and hSBA ≥1:8 Following One Dose of MenACWY-CRM Vaccine|The percentages of subjects with hSBA ≥1:4 and hSBA ≥1:8 after one dose of MenACWY-CRM vaccine (at 7-9 months), are reported|1 month post vaccine dose 1|The analysis was performed on the MenACWY per-protocol population||Percentages of subjects||95% Confidence Interval|Number
760480|NCT00626548|Primary|Progression Free Survival|Number of participants who have a progression event at the early analysis DCO, where progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline|Participants were followed up for progression every 4 weeks for the first 16 weeks then every 16 weeks|The analysis population only includes patients recruited by the time of the early analysis (1 October 2010)||Participants|||Number
760447|NCT00626327|Secondary|Percentages of Subjects Showing Seroconversion Response to Varicella Following Concomitant Administration of MMRV With MenACWY-CRM Vaccine.|"The percentages of subjects showing seroconversion response to varicella after concomitant administration of MMRV vaccine (at 12 months) with MenACWY-CRM vaccine compared to when MMRV vaccine is given alone, is reported .
Seroconversion for varicella is defined as percentage of subjects who show pre-vaccination antibody titer <1.25 gp ELISA units/mL to a post-vaccination antibody titer ≥1.25 gp ELISA units/mL."|6 weeks post vaccination|The analysis was performed on the MMRV per-protocol population||Percentages of subjects||95% Confidence Interval|Number
760448|NCT00626327|Secondary|Geometric Mean Titers Against Measles, Mumps, Rubella and Varicella Following One Dose of MMRV Vaccine.|The GMTs directed against measles, mumps, rubella and varicella, following one dose of MMRV vaccine (at 12 months) when given concomitantly with MenACWY-CRM vaccine compared to when MMRV vaccine was given alone, are reported.|6 weeks post vaccination|"The analysis was performed on the MMRV per-protocol population.
Only subjects with a baseline titer below the specified cut-off for that antigen were included in the immunogenicity analysis for the same antigen."||Titers||95% Confidence Interval|Geometric Mean
760449|NCT00626327|Secondary|Geometric Mean Titers Against Serogroups A, C, W-135 and Y, Following Two Doses of MenACWY-CRM Vaccine|The geometric mean titers (GMTs) directed against N.meningitidis serogroups A, C, W-135 and Y, following two doses of MenACWY-CRM vaccine (at 7-9 months and 12 months of age), when given concomitantly with MMRV vaccine (at 12 months) compared to when MenACWY-CRM vaccine was given alone, are reported.|6 weeks post vaccine dose 2|The analysis was performed on the MenACWY per-protocol population||Titers||95% Confidence Interval|Geometric Mean
760450|NCT00626327|Secondary|Percentages of Subjects With hSBA ≥1:4 After Two Doses of MenACWY-CRM Vaccine|The percentages of subjects with hSBA ≥1:4 directed against N. meningitidis serogroups A, C, W-135, and Y following two doses of MenACWY-CRM vaccine (at 7-9 and 12 months of age) when given concomitantly with MMRV vaccine (at 12 months) compared to when MenACWY-CRM vaccine was given alone, are reported.|6 weeks post vaccine dose 2|The analysis was performed on the MenACWY per-protocol population||Percentages of subjects||95% Confidence Interval|Number
760451|NCT00626327|Primary|Percentages of Subjects With hSBA ≥1:8 Following Two Doses of MenACWY-CRM Vaccine|The antibody response following two doses of MenACWY-CRM vaccine (at 7-9 months and 12 months) was considered adequate if the lower limit of the two-sided 95% CI for the percentage of subjects with hSBA ≥1:8, at 6 weeks following the second dose of MenACWY-CRM, was greater than 85% for serogroups C, W-135, or Y and greater than 65% for serogroup A.|6 weeks post vaccine dose 2|The analysis was performed on the MenACWY per-protocol population||Percentages of subjects||95% Confidence Interval|Number
760452|NCT00626327|Primary|Percentages of Subjects With Serum Bactericidal Titers ≥1:8 Following Concomitant Administration of MenACWY-CRM Vaccine With MMRV Vaccine.|"Percentages of subjects with hSBA ≥1:8, against N.meningitidis serogroups A, C, W-135, and Y following two doses of MenACWY-CRM vaccine (at 7-9 months and 12 months) when concomitantly administered with MMRV vaccine (12 months) compared to when MenACWY-CRM vaccine was given alone, are reported.
The serum bactericidal antibodies directed against N.meningitidis serogroups A, C, W-135, and Y, were measured by human complement Serum Bactericidal Assay (hSBA).
The immune response of MenACWY-CRM given concomitantly with MMRV was considered non-inferior to the immunogenicity of MenACWY-CRM administered alone if the lower limit of the two-sided 95% CI around the difference of the percentage of subjects with hSBA ≥1:8 at 6 weeks after the second dose of MenACWY-CRM given to 12-month old toddlers {P MMRV+MenACWY minus P MenACWY} was greater than -10% for each serogroup."|6 weeks post second dose|The analysis was performed on the MenACWY per-protocol population||Percentages of subjects||95% Confidence Interval|Number
760453|NCT00626327|Primary|Percentages of Subjects With a Seroresponse to Measles, Mumps, Rubella and Varicella Following Concomitant Administration of MMRV Vaccine With MenACWY-CRM Vaccine|"Percentages of subjects with seroresponses to measles, mumps, rubella and varicella after one dose of MMRV vaccine (at 12 months) when given concomitantly with MenACWY-CRM vaccine compared to when MMRV vaccine was given alone, are reported.
Seroresponse was defined as the percentage of initially seronegative subjects who show seroconversion to measles (≥255 mIU/mL), mumps (≥10 ELISA Ab units), rubella (≥10 IU/mL) and the percentage of initially seronegative subjects who show seroprotection (≥5 gp ELISA units/mL) for varicella.
Immunogenicity to measles, mumps, rubella and varicella at 6 weeks after vaccination with one dose of MMRV given concomitantly with MenACWY-CRM was considered non-inferior to immunogenicity of MMRV administered alone if the lower limit of two-sided 95% CI of the difference in the percentage of subjects with seroconversion for measles, mumps, and rubella, and seroprotection for varicella was greater than -5% (measles, mumps and rubella) and –10% (varicella)."|6 weeks post vaccination|The analysis was performed on the MMRV per-protocol population||Percentages of subjects||95% Confidence Interval|Number
760454|NCT00626340|Primary|Comparison of Cortical GABA Levels in 4 Groups of Subjects Using Estrogen Alone, Fluoxetine Alone, Estrogen and Fluoxetine Combined in Pre and Post 4.0T Magnetic Resonance Spectroscopy Sessions.|"This study was conducted at Yale University almost two decades ago. Our group at the University of Pennsylvania only has very basic information about this study. This includes the number of participants, which was 18, and the fact that no adverse events occurred. Staff members at the University of Pennsylvania do not have access to any additional study data. The contact person who initially entered this study protocol information is no longer at the University of Pennsylvania and we are unable to contact for additional information.
We only know that 18 participants completed, but as far as we know data was never analyzed for these 18 participants."|Healthy controls will undergo scans pre and post 3 weeks of estrogen treatment. Women with depression will undergo scans pre and post 6 weeks of treatment with estrogen alone, estrogen and fluoxetine, or fluoxetine alone|UPenn does not have access to the data collected for this study. We are only using the information entered in the protocol section for very basic details in the results section (i.e, number of participants completed). The original contact person for this protocol is not reachable.|||||
760455|NCT00626392|Secondary|Mean Number of Moderate or Greater Flushing Events Per Subject Per Week Overall During 4 Weeks of Niacin Extended-release (NER) Treatment|Flushing was assessed daily using the Flushing Assessment Tool via an e-diary and the mean number of flushing events per subject per week considered moderate or greater in severity was calculated. Flushing events were rated by the subject using a categorical scale of mild, moderate, severe, or very severe.|4 weeks|All subjects in the modified intent-to-treat population, defined as all subjects who took at least 1 dose of study medication and who had at least 1 entry in the Flushing Assessment Tool e-diary (n = 251).||Number of Events per Subject per Week||Standard Deviation|Mean
760456|NCT00626392|Secondary|Mean of Maximum Severity of Flushing Events Overall During 4 Weeks of Niacin Extended-release (NER) Treatment|Subjects assessed the severity of flushing events on a 10-point numeric rating scale of 1-3 (mild), 4-6 (moderate), 7-9 (severe), and 10 (very severe) using the Flushing Assessment Tool via an e-diary. For subjects who did not experience flushing, a score of 0 was assigned. Flushing was assessed daily.|4 weeks|All subjects in the modified intent-to-treat population, defined as all subjects who took at least 1 dose of study medication and who had at least 1 entry in the Flushing Assessment Tool e-diary (n = 251).||Scores on a Scale||Standard Deviation|Mean
760457|NCT00626392|Secondary|Maximum Severity of Flushing Events Overall During 4 Weeks of Niacin Extended-release (NER) Treatment|The maximum severity of flushing events subjects experienced during 4 weeks of NER treatment was categorized as none, mild, moderate, severe, or very severe using the Flushing Assessment Tool via an e-diary. Flushing was assessed daily and the percentage of subjects with maximum flushing severity in each category was calculated.|4 weeks|All subjects in the modified intent-to-treat population, defined as all subjects who took at least 1 dose of study medication and who had at least 1 entry in the Flushing Assessment Tool e-diary (n = 251).||Percentage of Subjects|||Number
760458|NCT00626392|Primary|Maximum Severity of Flushing Events During Week 1 of Niacin Extended-release (NER) Treatment|The maximum severity of flushing events subjects experienced during Week 1 of NER treatment was categorized as none, mild, moderate, severe, or very severe using the Flushing Assessment Tool via an e-diary. Flushing was assessed daily and the percentage of subjects with maximum flushing severity in each category was calculated.|From Baseline to end of Week 1|All subjects in the modified intent-to-treat population, defined as all subjects who took at least 1 dose of study medication and who had at least 1 entry in the Flushing Assessment Tool e-diary (n = 251).||Percentage of Subjects|||Number
760459|NCT00626431|Primary|Percentage of Subjects With Suppression of Serum Testosterone (<=50 ng/dL) From Week 4 to Week 48 for Formulation B: ITT Population for the Primary Endpoint Preplanned|The percentage of subjects with testosterone suppression (<= 50 ng/dL) from Week 4 to Week 48 was calculated by the Kaplan-Meier method for right-censored observations. Subjects who failed testosterone suppression were considered failures on the first day of a testosterone measurement (>50 ng/dL). Subjects who prematurely discontinued without escaping and those who were successfully suppressed through Week 48 were censored at their last measured testosterone value (Day 337 to Day 340 at Week 48). The 90% 2-sided confidence interval was calculated from Kaplan-Meier estimates.|Week 4 to Week 48|The ITT population for the primary endpoint was the same as the ITT population for the secondary endpoints and also excluded subjects whose final testosterone values were measured before Day 19 without suppression (>50 ng/dL) or whose testosterone levels remained suppressed through Week 48 but testosterone levels were not measured at Week 4.||Percent suppressed||90% Confidence Interval|Number
760460|NCT00626431|Secondary|Mean (+/- Standard Error) Prostate Specific Antigen (PSA) at Baseline, Visits Throughout the Study, and at Final Visit for Formulation B: ITT Population|PSA levels were measured at baseline and each treatment visit for Formulation B. The mean (+/- standard error) was calculated at each visit. The final visit occurred at Week 48 unless the subject prematurely discontinued the study.|Baseline, Day 8, Week 14, Week 24, Week 30, Week 40, Week 48, and the Final Visit|The ITT population included subjects who received at least 1 dose of study drug, who had at least 1 postbaseline measurement, and who did not use prohibited medications during the first 32 days after the initiation of study drug treatment that either lowered testosterone levels or blocked its action.||ng/mL||Standard Error|Mean
760461|NCT00626431|Secondary|Mean (+/- Standard Error) Prostate Specific Antigen (PSA) at Baseline, Visits Throughout the Study, and at Final Visit for Formulation A: ITT Population|PSA levels were measured at baseline and each treatment visit for Formulation A. The mean (+/- standard error) was calculated at each visit. The final visit occurred at Week 48 unless the subject prematurely discontinued the study.|Baseline, Day 8, Week 14, Week 24, Week 30, Week 40, Week 48, and the Final Visit|The ITT population included subjects who received at least 1 dose of study drug, who had at least 1 postbaseline measurement, and who did not use prohibited medications during the first 32 days after the initiation of study drug treatment that either lowered testosterone levels or blocked its action.||ng/mL||Standard Error|Mean
760462|NCT00626431|Secondary|Mean (+/- Standard Error) Acute-on-chronic Changes in Luteinizing Hormone From Pre-injection Levels for Formulation B: ITT Population|The acute-on-chronic effect is an agonistic stimulation of luteinizing hormone after the second depot injection of Formulation B. The mean +/- standard error changes were measured to assess this effect from just before to 2 weeks after the second injection.|Week 24 before the second injection until 2 weeks after Week 24 (2 h, 4 h, 8 h, 1 d, 2 d, 3-10 d, and 11-17 d postdose)|The ITT population included subjects who received at least 1 dose of study drug, who had at least 1 postbaseline measurement, and who did not use prohibited medications during the first 32 days after the initiation of study drug treatment that either lowered testosterone levels or blocked its action.||ng/dL||Standard Error|Mean
760463|NCT00626431|Secondary|Mean (+/- Standard Error) Acute-on-chronic Changes in Luteinizing Hormone From Pre-injection Levels for Formulation A: ITT Population|The acute-on-chronic effect is an agonistic stimulation of luteinizing hormone after the second depot injection of Formulation A. The mean +/- standard error changes were measured to assess this effect from just before to 2 weeks after the second injection.|Week 24 before the second injection until 2 weeks after Week 24 (2 h, 4 h, 8 h, 1 d, 2 d, 3-10 d, and 11-17 d postdose)|The ITT population included subjects who received at least 1 dose of study drug, who had at least 1 postbaseline measurement, and who did not use prohibited medications during the first 32 days after the initiation of study drug treatment that either lowered testosterone levels or blocked its action.||ng/dL||Standard Error|Mean
760464|NCT00626431|Primary|Adjusted Percentage of Subjects With Suppression of Serum Testosterone (<=50 ng/dL) From Week 4 to Week 48 for Formulation A: ITT Population for the Primary Endpoint Adjusted|The adjusted percentage of subjects with testosterone suppression (<= 50 ng/dL) from Week 4 to Week 48 was calculated by the Kaplan-Meier method for right-censored observations. The primary efficacy analysis was adjusted to censor subjects who received an anti-androgen at the last testosterone measurement before use of the anti-androgen. One additional subject was censored because of a laboratory error, at the last measurement before the error. The adjusted 90% 2-sided confidence interval was calculated from Kaplan-Meier estimates.|Week 4 to Week 48|||Percent Suppressed||90% Confidence Interval|Number
772075|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 2|Subject Satisfaction - soft enough to conceal when deflated|12 months post-surgery|||% satisfactory or somewhat satisfactory|||Number
760465|NCT00626431|Secondary|Mean (+/- Standard Error) Acute-on-chronic Changes in Testosterone From Pre-injection Levels for Formulation B: ITT Population|The acute-on-chronic effect is an agonistic stimulation of serum testosterone after the second depot injection of Formulation B. The mean +/- standard error changes were measured to assess this effect from just before to 2 weeks after the second injection.|Week 24 before the second injection until 2 weeks after Week 24 (2 h, 4 h, 8 h, 1 d, 2 d, 3-10 d, and 11-17 d postdose)|The ITT population included subjects who received at least 1 dose of study drug, who had at least 1 postbaseline measurement, and who did not use prohibited medications during the first 32 days after the initiation of study drug treatment that either lowered testosterone levels or blocked its action.||ng/dL||Standard Error|Mean
760466|NCT00626431|Secondary|Mean (+/- Standard Error) Acute-on-chronic Changes in Testosterone From Pre-injection Levels for Formulation A: ITT Population|The acute-on-chronic effect is an agonistic stimulation of serum testosterone after the second depot injection of Formulation A. The mean +/- standard error changes were measured to assess this effect from just before to 2 weeks after the second injection.|Week 24 before the second injection until 2 weeks after Week 24 (2 hours [h], 4 h, 8 h, 1 day [d], 2 d, 3-10 d, and 11-17 d postdose)|The ITT population included subjects who received at least 1 dose of study drug, who had at least 1 postbaseline measurement, and who did not use prohibited medications during the first 32 days after the initiation of study drug treatment that either lowered testosterone levels or blocked its action.||ng/dL||Standard Error|Mean
760467|NCT00626431|Secondary|Mean Testosterone Concentration (+/- Standard Error) at Each Visit for Formulation B: ITT Population|Baseline was the last measurement before the first dose of Formulation B. The mean +/- standard error was calculated at each visit. The final visit occurred at Week 48 unless the subject prematurely discontinued the study.|Baseline, Days 2 and 8, Weeks 2, 4, 8, 14, 20, 24, 26, 30, 34, 40, 46, 48, and Final Visit|The ITT population included subjects who received at least 1 dose of study drug, who had at least 1 postbaseline measurement, and who did not use prohibited medications during the first 32 days after the initiation of study drug treatment that either lowered testosterone levels or blocked its action.||ng/dL||Standard Error|Mean
760468|NCT00626431|Secondary|Mean Testosterone Concentration (+/- Standard Error) at Each Visit for Formulation A: ITT Population|Baseline was the last measurement before the first dose of Formulation A. The mean +/- standard error was calculated at each visit. The final visit occurred at Week 48 unless the subject prematurely discontinued the study.|Baseline, Days 2 and 8, Weeks 2, 4, 8, 14, 20, 24, 26, 30, 34, 40, 46, 48, and Final Visit|The ITT population included subjects who received at least 1 dose of study drug, who had at least 1 postbaseline measurement, and who did not use prohibited medications during the first 32 days after the initiation of study drug treatment that either lowered testosterone levels or blocked its action.||ng/dL||Standard Error|Mean
760469|NCT00626431|Primary|Percentage of Subjects With Suppression of Serum Testosterone (<=50 ng/dL) From Week 4 to Week 48 for Formulation A: Intent-to-treat (ITT) Population for the Primary Endpoint.|The percentage of subjects with testosterone suppression (<= 50 ng/dL) from Week 4 to Week 48 was calculated by the Kaplan-Meier method for right-censored observations. Subjects who failed testosterone suppression were considered failures on the first day of a testosterone measurement (>50 ng/dL). Subjects who prematurely discontinued without escaping and those who were successfully suppressed through Week 48 were censored at their last measured testosterone value (Day 337 to Day 340 at Week 48). The 90% 2-sided confidence interval was calculated from Kaplan-Meier estimates.|Week 4 to Week 48|The ITT population for the primary endpoint was the same as the ITT population for the secondary endpoints and also excluded subjects whose final testosterone values were measured before Day 19 without suppression (>50 ng/dL) or whose testosterone levels remained suppressed through Week 48 but testosterone levels were not measured at Week 4.||Percent Suppressed||90% Confidence Interval|Number
760470|NCT00626444|Secondary|Duration of Response||10 weeks||||||
760471|NCT00626444|Primary|Progression-free Survival||10 weeks||||||
760472|NCT00626522|Secondary|Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) for 0-6 hr||Baseline and treatment Week 4|ITT Population defined as all randomised patients who took at least one dose of investigational medicinal product and had at least the baseline and one post-baseline efficacy assessments||Liters||95% Confidence Interval|Least Squares Mean
760473|NCT00626522|Secondary|Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) for 0-3 hr||Baseline and treatment Week 4|ITT Population defined as all randomised patients who took at least one dose of investigational medicinal product and had at least the baseline and one post-baseline efficacy assessments||Liters||95% Confidence Interval|Least Squares Mean
760474|NCT00626522|Secondary|Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1)||Baseline and treatment Week 4|ITT Population defined as all randomised patients who took at least one dose of investigational medicinal product and had at least the baseline and one post-baseline efficacy assessments||Liters||95% Confidence Interval|Least Squares Mean
760475|NCT00626522|Secondary|Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1)||Baseline and treatment Week 4|ITT Population defined as all randomised patients who took at least one dose of investigational medicinal product and had at least the baseline and one post-baseline efficacy assessments||Liters||95% Confidence Interval|Least Squares Mean
760476|NCT00626522|Primary|Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) for 0-12 hr||Baseline and treatment Week 4|ITT Population defined as all randomised patients who took at least one dose of investigational medicinal product and had at least the baseline and one post-baseline efficacy assessments||Liters||95% Confidence Interval|Least Squares Mean
760477|NCT00626548|Secondary|Time to Symptomatic Progression||Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks||||||
760478|NCT00626548|Secondary|Time to Prostate-specific Antigen (PSA) Progression||Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks||||||
760479|NCT00626548|Secondary|Health Related Quality of Life||Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks||||||
760481|NCT00626548|Primary|Overall Survival|Number of participants who have died at early analysis data cut off (DCO)|From date of randomization until date of death, assessed up to 33 months|The analysis population only includes patients recruited by the time of the early analysis (1 October 2010)||Participants|||Number
760486|NCT00626574|Primary|Incidence of Adverse Events After Administering Intravenous Doses of Procrit® Once Daily for Three Consecutive Days to Patients With Aneurysmal SAH Before and After Vascular Clipping|Number of adverse events|First 10 days following clipping and 6 week F/U|Pilot Study- per protocol||adverse events|||Number
760487|NCT00626639|Secondary|Overall Survival|Deaths during long-term follow up of subject participating in the acute phase of the study receiving placebo or Palifermin.|During long-term follow-up phase, until December 2015|Subjects who received placebo duringthe acute phase of the study.||Participants|||Count of Participants
760488|NCT00626639|Secondary|Number of Participants With Disease Progression by Week 12|Disease progression was determined by clinical examination and histopathologic examination by the Investigator.|Up to Week 12|Tumor response data was missing for one participant.||participants|||Number
760489|NCT00626639|Secondary|Patient-Reported Mouth and Throat Soreness Score|"The average patient-reported mouth and throat soreness (MTS) score as reported on question 3 of the Oral Mucositis Questionnaire for Head and Neck Cancer [OMQ-HN]): How much mouth and throat soreness did you experience in the past 24 hours? Participants answered on a scale from 0 (no soreness) to 4 (extreme soreness).
Due to the small sample size this analysis was not performed."|Assessed daily up to Week 12 (or Week 15 if severe oral mucositis not resolved ≤ adapted RTOG/EORTC Grade 2 by Week 12).||||||
760490|NCT00626639|Secondary|Number of Participants With Severe Oral Mucositis (OM) (Adapted RTOG/EORTC Grade ≥3)|"The adapted RTOG/EORTC mucositis assessment scale as follows: Grade 0 = no change; Grade 1 = mild enanthema, mild pain; Grade 2 = patchy mucositis, moderate edema, moderate pain; Grade 3 = confluent fibrinous mucositis, massive edema, massive pain; Grade 4 = extensive ulceration, confluent necrosis, massive hemorrhage.
Due to the small sample size this analysis was not performed."|Assessed daily up to Week 12 (or Week 15 if severe oral mucositis not resolved ≤ adapted RTOG/EORTC Grade 2 by Week 12).||||||
760491|NCT00626639|Primary|Pharmacokinetics of Palifermin|Due to the small sample size this analysis was not performed.|Day -3, predose and at 2, 5, 15, 30, 60, and 90 minutes and 2, 4, 6, 8, 10, 12, 24 and 48 hours after the first dose||||||
760492|NCT00626639|Primary|Ratio of Ki67-positive Cells Before and After Palifermin Treatment|The effect of palifermin on cell proliferation was to be assayed by staining for the cell cycle proliferation marker Ki67 in buccal mucosal biopsy samples taken prior to the first dose and either 24 or 48 hours after the first dose. Due to the small sample size, this analysis was not performed.|Day -3 predose and 24 or 48 hours post-dose||||||
760493|NCT00626639|Primary|Number of Participants With Adverse Events (AEs)|An adverse event is an undesirable medical occurrence (sign, symptom, or diagnosis) or worsening of a pre-existing medical condition occurring after start of study drug up to the end of acute oral mucositis (OM) evaluation phase, whether or not considered to be study drug related. If severe OM was not resolved by Week 12, AEs were documented until resolution of severe OM or Week 15, whichever occurred first. A serious AE is any event that is fatal, life threatening, requires or prolongs hospitalization, is a persistent or significant disability/incapacity or is a congenital anomaly/birth defect. The intensity of AEs was graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v3 based on the following: Grade 1 = Mild AE, Grade 2 = Moderate AE, Grade 3 = Severe AE, Grade 4 = Life-threatening or disabling AE, Grade 5 = Death related to AE. A Protocol-specific Limiting Toxicity (PSLT) is any non-hematologic Grade 3 or 4 AE considered related to study drug.|Up to Week 12 (or Week 15 for participants with severe OM was not resolved by Week 12)|||participants|||Number
760494|NCT00626743|Secondary|Maximal Change From Baseline in Standing DBP||within 8 hrs after SK3530 or placebo|||mmHg||Standard Deviation|Mean
760495|NCT00626743|Primary|Maximal Change From Baseline in Standing SBP||within 8 hrs after SK3530 or placebo|||mmHg||Standard Deviation|Mean
760496|NCT00626782|Secondary|Efficacy|Mean change in intraocular pressure, number of glaucoma medications, bleb appearance based on the Indiana Bleb Appearance grading scale.|1 day, 2 wks, 1, 3, 6 and 12 months||||||
760497|NCT00626782|Primary|Adverse Events|Percentage of participants with ocular adverse events and other adverse events as identified by eye examination, physical examination, subject reporting and changes in vital signs.|1 day, 2 wks, 1, 3, 6 and 12 months|||percentage of participants|||Number
760498|NCT00626808|Primary|Number of Days With a Respiratory Claim in 28 Days Prior to Vaccination: 2 or More|Among participants vaccinated with FluMist, the number of days with a respiratory claim (asthma, acute respiratory distress, bronchospasm, influenza, respiratory syncytial virus, bronchiolitis, bronchitis, pneumonia, croup, sinusitis, adenovirus infection, coxsackie virus infection, rhinovirus infection, nasopharyngitis, laryngitis and tracheitis, upper respiratory infection, cough) in the 28 days prior to vaccination.|2009-2010|General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression.||Number of participants|||Number
760499|NCT00626808|Primary|Number of Days With a Respiratory Claim in 28 Days Prior to Vaccination: 1|Among participants vaccinated with FluMist, the number of days with a respiratory claim (asthma, acute respiratory distress, bronchospasm, influenza, respiratory syncytial virus, bronchiolitis, bronchitis, pneumonia, croup, sinusitis, adenovirus infection, coxsackie virus infection, rhinovirus infection, nasopharyngitis, laryngitis and tracheitis, upper respiratory infection, cough) in the 28 days prior to vaccination.|2009-2010|General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression.||Number of participants|||Number
760500|NCT00626808|Primary|Number of Days With a Respiratory Claim in 28 Days Prior to Vaccination: 0|Among participants vaccinated with FluMist, the number of days with a respiratory claim (asthma, acute respiratory distress, bronchospasm, influenza, respiratory syncytial virus, bronchiolitis, bronchitis, pneumonia, croup, sinusitis, adenovirus infection, coxsackie virus infection, rhinovirus infection, nasopharyngitis, laryngitis and tracheitis, upper respiratory infection, cough) in the 28 days prior to vaccination.|2009-2010|General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression.||Number of participants|||Number
760501|NCT00626808|Primary|Number of Outpatient Visits: 2 or More|Among participants vaccinated with FluMist, the number who had 2 or more outpatient visits in the 3 months prior to vaccination|2009-2010|General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression.||Number of participants|||Number
760502|NCT00626808|Primary|Number of Outpatient Visits: 1|Among participants vaccinated with FluMist, the number who had 1 outpatient visit in the 3 months prior to vaccination|2009-2010|General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression.||Number of participants|||Number
760503|NCT00626808|Primary|Number of Outpatient Visits: 0|Among participants vaccinated with FluMist, the number who had 0 outpatient visits in the 3 months prior to vaccination|2009-2010|General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression.||Number of participants|||Number
760504|NCT00626808|Primary|Geographic Region: Western|Geographic region of parents' residence among participants receiving FluMist|2009-2010|General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression.||Number of participants|||Number
760505|NCT00626808|Primary|Geographic Region: Southern|Geographic region of parents' residence among participants receiving FluMist|2009-2010|General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression.||Number of participants|||Number
760506|NCT00626808|Primary|Geographic Region: North Central|Geographic region of parents' residence among participants receiving FluMist|2009-2010|General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression.||Number of participants|||Number
760507|NCT00626808|Primary|Geographic Region: Northeastern|Geographic region of parents' residence among participants receiving FluMist|2009-2010|General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression.||Number of participants|||Number
760508|NCT00626808|Primary|Vaccinating Physician Specialty: Unknown|Specialty of vaccinating physician who provided FluMist|2009-2010|General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression.||Number of physicians|||Number
760509|NCT00626808|Primary|Vaccinating Physician Specialty: Other|Specialty of vaccinating physician who provided FluMist|2009-2010|General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression.||Number of physicians|||Number
760510|NCT00626808|Primary|Vaccinating Physician Specialty: General/Family Practitioner|Specialty of vaccinating physician who provided FluMist|2009-2010|General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression.||Number of physicians|||Number
760511|NCT00626808|Primary|Vaccinating Physician Specialty: Pediatrician or Pediatric Specialist|Specialty of vaccinating physician who provided FluMist.|2009-2010|General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression.||Number of physicians|||Number
760512|NCT00626808|Primary|FluMist Use in Participants up to 59 Months of Age|Among participants up to 59 months of age who received any flu vaccine, number who received FluMist|2009-2010|General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression.||Number of participants|||Number
760513|NCT00626821|Primary|Quality of Life (Scale 0(Worst)-100(Best))|The mean change in quality of life (Stoma-QoL value) from visit 1 to visit 2. An increase in Stoma-QoL is an improvement, a decrease in Stoma-QoL is a worsening.|6-8 weeks|ITT||units on a scale||Standard Deviation|Mean
760514|NCT00626925|Secondary|Gamma-glutamyl Transferase (GGT) at End of Treatment|Gamma-glutamyl transferase (GGT) is a liver enzyme biochemical measure used to detect liver health and function and alcohol consumption. GGT is a very sensitive measure than can change very quickly compared to other biochemical markers.|12 weeks (from initiation to end of treatment)|ITT||IU/L||Standard Deviation|Mean
760515|NCT00626925|Secondary|Gamma-glutamyl Transferase (GGT) at Midpoint|Gamma-glutamyl transferase (GGT) is a liver enzyme biochemical measure used to detect liver health and function and alcohol consumption. GGT is a very sensitive measure than can change very quickly compared to other biochemical markers.|6 weeks (from initiation to midpoint)|Subjects were measured at midpoint.||IU/L||Standard Deviation|Mean
760516|NCT00626925|Secondary|Severity of Alcohol-related Problems at End of Treatment|The Short Inventory of Problems (SIP). The SIP, a 15-item instrument, yields a total score that ranges from 0 to 45, higher score indicating higher levels of drinking problems. The SIP was derived from the Drinker Inventory of Consequences (DrInC), which was developed for use in Project MATCH (Miller and Tonigan 1995). We (Feinn et al. 2003) have found that, like the DrInC, the SIP measures a single factor of alcohol-related problems. Given that it is substantially shorter than the DrInC, we will use the SIP as a measure of alcohol-related consequences.|12 weeks (from intiation to end of treatment)|Subject were measured at Baseline and Endpoint.||units on a scale||Standard Deviation|Mean
760517|NCT00626925|Secondary|Mean Abstinent Days Per Week by Medication Group and rs2832407 Genotype||12 weeks|ITT||Mean Abstinent Days Per Week||Standard Error|Mean
760518|NCT00626925|Secondary|Mean Heavy Drinking Days Per Week by Medication Group and rs2832407 Genotype||12 weeks|ITT||Mean Heavy Drinking Days Per Week||Standard Error|Mean
760519|NCT00626925|Secondary|Mean Daily Alcohol Consumption||12 weeks (from initiation to end of treatment); 3- and 6-months post-treatment||||||
760520|NCT00626925|Secondary|Mean Abstinent Days Per Week by Medication Group||12 weeks|Intention to treat (ITT).||Mean abstinent days per week||Standard Error|Mean
760521|NCT00626925|Primary|Mean Heavy Drinking Days Per Week by Medication Group|Change in the number of heavy drinking days during treatment phase of study. Drinking data were aggregated to the weekly level. The number of days per week of heavy drinking (i.e., four or more drinks in a day for women and five or more drinks in a day for men) and of abstinence were the primary outcomes.|12 weeks (from initiation to end of treatment)|Intention to treat (ITT)||Number of heavy drinking days||Standard Error|Mean
761425|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Total Airway Resistance (Raw)||Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)||Percentage||Standard Deviation|Mean
760522|NCT00627016|Secondary|Percentage of Participants With Relief of Gastro-Esophageal Reflux Disease (GERD) Associated Sleep Disturbances Over the Last 7 Days of Treatment as Assessed by Daily Diary.|Relief of GERD-associated sleep disturbance was defined as 6 of 7 nights with no GERD associated sleep disturbances; lack of relief of GERD-associated sleep disturbance was defined as 2 or more out of 7 nights with GERD-associated sleep disturbance. Subjects indicate the presence (Yes/No) of GERD associated sleep disturbance in a Daily Electronic Diary. The percentage was calculated as the number of subjects with relief of GERD-associated sleep disturbance divided by the number of subjects whose relief status could be determined.|Last 7 days of treatment|Analysis was conducted on intent-to-treat subjects (randomized subjects who received at least 1 dose of study drug) who had sufficient diary data to allow for determination of relief status.||Percentage of participants|||Number
760523|NCT00627016|Secondary|Percent of Subjects With Relief of Night Time Heartburn Over the Last 7 Days of Treatment as Assessed by Daily Diary.|Relief of nighttime heartburn was defined as 6 of 7 nights with no heartburn and at most 1 night with mild heartburn; lack of relief of nighttime heartburn was defined as 2 or more out of 7 nights with heartburn, or 1 night with at least moderate heartburn. Subjects indicate the presence and severity (mild, moderate, severe, or very severe) of nocturnal heartburn in a Daily Electronic Diary. The percentage was calculated as the number of subjects with relief of nighttime heartburn divided by the number of subjects whose relief status could be determined.|Last 7 days of treatment|Analysis was conducted on intent-to-treat subjects (randomized subjects who received at least 1 dose of study drug) who had sufficient diary data to allow for determination of relief status.||Percentage of participants|||Number
760524|NCT00627016|Primary|Median Percentage of Nights Without Heartburn Over 4 Weeks as Assessed by Daily Diary.|Percentage calculated by the number of heartburn-free nights out of the total number of nights during the treatment period with a diary entry indicating presence or absence of nighttime heartburn in subjects who had ≥1 diary entry indicating presence or absence of nighttime heartburn, as indicated by the subject's daily diary. Subjects indicate the presence (Yes/No) of nocturnal heartburn symptoms in a Daily Electronic Diary. Nights missing diary results were excluded from the numerator and denominator.|4 Weeks|Analysis was conducted on intent-to-treat subjects (randomized subjects who received at least 1 dose of study drug) who completed at least 1 diary entry for nighttime heartburn during treatment.||Percentage of nights||Inter-Quartile Range|Median
760525|NCT00627042|Secondary|Number of Participants With Drug-Related Treatment-Emergent Adverse Events|Data presented are the number of participants who experienced treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), Grade 3 or higher TEAEs, or adverse events (AEs) leading to discontinuation of treatment that were considered by the investigator to be related to ramucirumab. A summary of SAEs and other nonserious AEs, regardless of causality, is located in the Reported Adverse Events section.|First dose to 37.5 months|Intent-to-treat population: Participants who received at least 1 dose of ramucirumab.||participants|||Number
760526|NCT00627042|Secondary|Number of Participants With Serum Anti-Ramucirumab Antibodies||Prior to dosing at baseline, Cycles 4 and 7, and 30 days after end of therapy (1 cycle=2 weeks)|Intent-to-treat population: Participants who received at least 1 dose of ramucirumab.||participants|||Number
760527|NCT00627042|Secondary|Duration of Response|Duration of response was the interval from the date of initial documented response [complete response (CR) or partial response (PR)] to the first documented date of disease progression, initiation of other (or additional) antitumor therapy was first reported, or death due to any cause. As classified according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria, CR was the disappearance of all target lesions, PR was having at least a 30% decrease in the sum of the longest diameter of target lesions, and disease progression was having at least a 20% increase in the sum of the longest diameter of target lesions and/or unequivocal progression of a non-target lesion and/or detection of a new lesion. Data were censored for participants who did not progress or die.|Time of first response (CR or PR) to disease progression, or death due to any cause [every 3 cycles up to 18 months (1 cycle=2 weeks)]|Participants who received at least 1 dose of ramucirumab and had a CR or PR. The number of participants censored 2.||months||95% Confidence Interval|Median
760528|NCT00627042|Secondary|Percentage of Participants With Complete Response or Partial Response (Objective Response Rate)|Objective response rate (ORR) was defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR). As classified according to Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria, CR was the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeters (mm) and normalization of tumor marker level of non-target lesions. PR was having at least a 30% decrease in sum of longest diameter of target lesions.|First dose to date of objective progressive disease (PD) or death up to 18 months|Intent-to-treat population: Participants who received at least 1 dose of ramucirumab.||percentage of participants||95% Confidence Interval|Number
760529|NCT00627042|Secondary|Overall Survival|Overall survival (OS) was the duration from first dose to death due to any cause. OS was censored at last contact date for participants who were alive at the end of follow-up period or lost to follow-up.|First dose to death due to any cause up to 37.5 months|Intent-to-treat population: Participants who received at least 1 dose of ramucirumab. The number of participants censored was 10.||months||95% Confidence Interval|Median
760530|NCT00627042|Secondary|Time to Progression|The time from first day of therapy to the first date of objective evidence of progressive disease (PD) by Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD was defined as having at least a 20% increase in sum of longest diameter of target lesions and/or unequivocal progression of a non-target lesion and/or detection of new lesion. Time to PD was censored at the date of death or study discontinuation.|First dose to date of PD [every 3 cycles up to 18 months (1 cycle=2 weeks)]|Intent-to-treat population: Participants who received at least 1 dose of ramucirumab. The number of participants censored was 20.||months||95% Confidence Interval|Median
760559|NCT00634920|Secondary|Percentage of Participants With Treatment Failures|Treatment failure was defined as graft loss or death.|Months 12, 24, 36|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).||Percentage of participants|||Number
765711|NCT00679367|Secondary|Number of Participants Removed From Study Due to Toxicities|Number of study participants removed from study treatment due to toxicities|One year|All patients who have had at least one dose of drug.||Participants|||Count of Participants
760531|NCT00627042|Primary|Progression Free Survival (PFS) in Participants With Unresectable Hepatocellular Cancer Treated With the Monoclonal Antibody Ramucirumab|PFS was defined as the time from the first day of therapy to the first evidence of disease progression or death from any cause. As classified according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria, disease progression was having at least a 20% increase in the sum of the longest diameter of target lesions and/or unequivocal progression of a non-target lesion and/or detection of a new lesion. Participants who were alive and without disease progression and participants who did not progress and were subsequently lost to follow-up were censored at the last objective tumor assessment.|First dose to date of progressive disease or death due to any cause [every 3 cycles up to 18 months (1 cycle=2 weeks)]|Intent-to-treat population: Participants who received at least 1 dose of ramucirumab. The number of participants censored was 13.||months||95% Confidence Interval|Median
760532|NCT00627094|Secondary|Adverse Events|Number of Adverse events reported which were evaluated to be related or possible related to the device|Continuously from start of treatment to end of trial (day 43)|||Number of AE|||Number
760533|NCT00627094|Secondary|Change From Baseline in Ulcer Area|Relative change from baseline in ulcer area using last observation carried forward. A positive outcome value Means that wound size has decreased and thus reflects wound healing (clinical improvement)|Change from baseline to end of trial (day 43)|ITT population||Relative change from baseline in percent||Standard Deviation|Median
760534|NCT00627094|Secondary|Pain Intensity (PI) Change|Pain intensity (PI) assesment performed daily during the days 1-5. Pain intensity assesment performed on a 11 point numerical box scale: 0 was no pain and 10 was worst possible pain. A positive outcome measure value (PI (baseline) - PI (day 4 evening)) means that PI has decreased since baseline and thus reflects clinical improvement (patients suffer less from pain).|Change from baseline in Pain Intensity (PI) on day 4 evening|PP-population (The PP population consisted of all randomized subjects that fulfilled the inclusion/exclusion criteria and which did not violate the protocol in a serious way day 1-5) - Evaluation performed on un-blinded data before database lock.||Change in PI since baseline||Standard Deviation|Mean
760535|NCT00627094|Primary|Pain Relief|The distribution of pain relief assesment during day 1 to 5. The pain relief was registrated on 5-point verbal rating scales (evening/morning) from day 1 to day 5 after start of treatment.|Pain relief (morning/evening) after start of treatment from day 1 (evening) to day 5 (morning)|ITT population||percentage of scores within category|Total Number of scores day 1-5||Number
760536|NCT00634842|Secondary|Incidence of Hypoglycaemic Episodes (All, Major, Minor and Symptoms Only)|"Incidence of hypoglycaemic episodes (all, major, minor and symptoms only) occurring during the treatment period from week 0 to week 20. Classification was as follows:
If subject was unable to treat himself: Major incidence.
If subject could treat himself and plasma glucose was less than 3.1 mmol/l: Minor incidence.
If subject could treat himself and plasma glucose was equal to or greater than 3.1 mmol/l, or there was no plasma glucose measurement: Symptoms only."|weeks 0-20|The safety population consists of all subjects exposed to study drug.||number of events|||Number
760537|NCT00634842|Secondary|Change in Glycosylated Haemoglobin A1c (HbA1c) Percentage From Baseline|Change in glycosylated haemoglobin A1c (HbA1c) percentage from baseline measured from week -2 to week 20|week -2, week 20|The intent-to-treat (ITT), LOCF (last observation carried forward) population. One Subject in 70-90 group, however, had a missing baseline value, therefore, no change from baseline could be calculated.||percentage point change||Standard Error|Least Squares Mean
760538|NCT00634842|Secondary|Percentage of Participants Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than or Equal to 6.5%|Percentage (%) of participants reaching glycosylated haemoglobin A1c (HbA1c) less than or equal to 6.5% measured after 20 weeks of treatment|week 20|The intent-to-treat (ITT) population with non-missing HbA1c values at end of study, LOCF (last observation carried forward)||percentage of participants|||Number
760539|NCT00634842|Primary|Percentage of Participants Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than 7%|Percentage (%) of subjects reaching glycosylated haemoglobin A1c (HbA1c) less than 7% measured after 20 weeks of treatment|week 20|The intent-to-treat (ITT) population with non-missing HbA1c values at end of study, LOCF (last observation carried forward)||percentage of participants|||Number
760540|NCT00634907|Post-Hoc|Mean Number of Doses Before the First Supratherapeutic INR|The number of warfarin doses administered before a patient INR exceeded the therapeutic range (>2.9) was recorded. The average was then calculated and is shown here.|2 weeks (knee arthroplasty) or 4 weeks (hip arthroplasty)|||doses administered||Standard Deviation|Mean
760541|NCT00634907|Post-Hoc|Mean Number of Doses Required for the First Therapeutic INR|The number of doses required to achieve a therapeutic INR (1.8-2.9) was determined per patient, per arm. The average was then calculated and is shown here.|2 weeks (knee arthroplasty) or 4 weeks (hip arthroplasty)|||doses||Standard Deviation|Mean
760542|NCT00634907|Post-Hoc|Percent of Patients With Dose Adjustments|The percent of patients that required a dose adjustment during the study period was calculated.|2 weeks (knee arthroplasty) or 4 weeks (hip arthroplasty)|||percentage of patients|||Number
760543|NCT00634907|Post-Hoc|Mean Number of Dose Adjustments|The average number of dose adjustments made per patient, per arm, during the study period was calculated|2 weeks (knee arthroplasty) or 4 weeks (hip arthroplasty)|||doses||Standard Deviation|Mean
760544|NCT00634907|Post-Hoc|Mean Number of Doses Before First Dose Adjustment|The number of consistent doses administered before the first dose adjustment was required was recorded, per patient. The average number of doses administered before the first dose adjustment is shown.|2 weeks (knee arthroplasty) or 4 weeks (hip arthroplasty)|||doses||Standard Deviation|Mean
760545|NCT00634907|Secondary|Percentage of Determinations Supratherapeutic (INR>2.9)|"Patient response to warfarin was evaluated based on the international normalized ratio (INR), calculated from a prothrombin time blood test. When the INR value was greater than 2.9, the patient was considered to be supratherapeutic. The proportion of INR determinations that were supratherapeutic was calculated, per arm, based on total number of INR determinations that were made during treatment with warfarin."|2 weeks (knee arthroplasty) or 4 weeks (hip arthroplasty)|Determinations were assessed cumulatively throughout the study period, per patient, per arm. The total number of determinations was 804 for the genotype arm and 780 for the control arm||percentage of determinations|||Number
760614|NCT00635102|Secondary|Continuous Performance Task (CPT) - Vigilance - A-Prime Score 30 Minutes|gordon diagnostic system is a continuous performance task (CPT) to measure Vigilance - (A-Prime score range 0 minimum - 1 maximum - The higher number the better the performance)|30 minutes|||units on a scale||Standard Deviation|Mean
760546|NCT00634907|Secondary|Percentage of Determinations Subtherapeutic (INR<1.8)|"Patient response to warfarin was evaluated based on the international normalized ratio (INR), calculated from a prothrombin time blood test. When the INR value was less than 1.8, the patient was considered to be subtherapeutic. The proportion of INR determination that were subtherapeutic was caluculated, per arm, based on the total number of INR determinations that were made during treatment with warfarin."|2 weeks (knee arthroplasty) or 4 weeks (hop arthroplasty)|Determinations were assessed cumulatively throughout the study period, per patient, per arm. The total number of determinations was 804 for the genotype arm and 780 for the control arm||percentage of deteminations|||Number
760547|NCT00634907|Secondary|Percentage of Determinations in Therapuetic Range (INR 1.8-2.9)|"Patient response to warfarin was evaluated based on the international normalized ratio (INR), calculated from a prothrombin time blood test. When the INR value was between 1.8 and 2.9, the patient was considered to be therapeutic. The proportion of INR determinations that fell within the therapeutic range (INR between 1.8-2.9) was calculated, per arm, based on total number of INR determinations that were made during treatment with warfarin."|2 weeks (knee arthroplasty) or 4 weeks (hip arthroplasty)|Determinations were assessed cumulatively throughout the study period, per patient, per arm. The total number of determinations was 804 for the genotype arm and 780 for the control arm||percentage of therapeutic INR values|||Number
760548|NCT00634907|Primary|The Number of Participants With Adverse Events Associated With Warfarin Anticoagulation Following Total Hip and Total Knee Replacement|"Adverse events were defined as
Major bleeding: fatal bleeding, bleeding into a critical organ, bleeding that requires hospital admission
Minor bleeding: clinically overt bleeding not meeting criteria for major bleeding
Symptomatic deep vein thrombosis (DVT)
Pulmonary embolism (PE)"|90 days post surgery|||participants|||Number
760549|NCT00634920|Secondary|Health-related Quality of Life (QoL) as Measured by EuroQoL EQ-5D|Health-related QoL was assessed using the EQ-5D questionnaire. The EQ-5D self-report questionnaire consists of the EQ-5D descriptive system that measures health-related quality of life on 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which can take one of three responses. The responses record three levels of severity (no problems/moderate problems/severe problems) within a particular EQ-5D dimension. Scores are transformed to a range of 0-1, in which higher scores reflect better health status.|Before randomization, Months 12, 36|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).||scores on a scale||Standard Deviation|Mean
760550|NCT00634920|Secondary|Percentage of Participants Who Had Donor Specific Antibodies (DSA)|Venous blood was drawn for donor specific (DSA) measurements prior to transplantation and at the final visit (36 months). The blood sample was first screened for the presence of PRA i.e. donor specific Immunoglobulin-G antibodies against specific HLA antigens. If PRA antibodies were detected, the blood sample was tested for specific DSAs on single antigen Luminex beads (coated with single HLA class I or II molecules). In this way, the specificity of these antibodies could be determined.|Month 36|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).||Percentage of participants|||Number
760551|NCT00634920|Secondary|Proteinuria (Measured as Urine Albumin/Creatinine Ratio (mg/mmol))|Proteinuria is when a large amount of protein, that should remain circulating in a person’s blood, is “spilled” into their urine and eliminated from the body.|Months 12, 24, 36|The safety population (SAF) consists of all patients in whom TX was performed and who were randomized and treated with at least one dose of randomized treatment.||mg/mmol||Standard Deviation|Mean
760552|NCT00634920|Secondary|Percentage of Participants on Antihypertensive Drugs||Months 12, 24, 36|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).||Percentage of participants|||Number
760553|NCT00634920|Secondary|Number of Antihypertensive Drugs Taken||Months 12, 24, 36|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).||Number of antihypertensive dugs||Standard Deviation|Mean
760554|NCT00634920|Secondary|Percentage of Participants on Lipid-lowering Drugs||Months 12, 24, 36|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).||Percentage of participants|||Number
760555|NCT00634920|Secondary|Number of Lipid-lowering Drugs Taken||Months 12, 24, 36|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).||Number of lipid-lowering drugs||Standard Deviation|Mean
760556|NCT00634920|Secondary|Lipid Profile for HDL-C, LDL-C,Total Cholesterol, and Triglycerides|Blood lipid levels of patients in both groups: HDL-C, LDL-C,Total cholesterol, and triglycerides.|Months 12, 24, 36|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).||mmol/L||Standard Deviation|Mean
760557|NCT00634920|Secondary|Lipid Profile for Apolipoprotein|Blood lipid levels of patients in both groups for Apolipoprotein (Apo) A1 and B.|Months 12, 24, 36|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).||g/L||Standard Deviation|Mean
760558|NCT00634920|Secondary|Time to First Malignancy|This is the time to first diagnosed malignancy. Malignancies (skin- or solid cancer) were listed whether they reoccurred in situ, were metastatic or de novo. This is shown as mean time.|Months 12, 24, 36|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).||Months||Standard Error|Mean
760560|NCT00634920|Secondary|Time to Treatment Failure|Treatment failure was defined as graft loss or death.Time to treatment failure is shown as mean time to treatment failure.|Months 12, 24, 36|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).||Days||Standard Error|Mean
760561|NCT00634920|Secondary|Percentage of Participants With Graft Loss or Death|The allograft was presumed to be lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis. If the patient underwent a graft nephrectomy, the day of nephrectomy was the day of graft loss. Graft loss was considered an SAE (serious adverse event).|Months 12, 24, 36|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).||Percentage of participants|||Number
760562|NCT00634920|Secondary|Percentage of Participants With Biopsy Proven Acute Rejection (BPAR)|A BPAR was defined as a biopsy graded IA, IB, IIA, IIB, or III (Banff 97 classification). Biopsy graded IA: Significant interstitial infiltration (> 25% of parenchyma) and foci of moderate tubulitis (> 4 mononuclear cells/tubular cross section or group of 10 tubular cells). Biopsy grade IB: Significant interstitial infiltration (> 25% of parenchyma) and foci of severe tubulitis (> 10 mononuclear cells/tubular cross section or group of 10 tubular cells). Biopsy grade IIA: Mild to moderate intimal arteritis. Biopsy graded IIB: Severe intimal arteritis comprising > 25% of the lumenal area.|Months 12, 24, 36|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).||Percentage of participants|||Number
760563|NCT00634920|Secondary|Percentage of Participants Who Developed CAN (Chronic Allograft Nephropathy)|Assessed by protocol biopsies findings (Banff 1997 lesion scores and morphometry of the interstitial space)|Month 12, Month 36|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).||Percentage of participants|||Number
760564|NCT00634920|Secondary|Progression of Measured Glomerular Filtration Rate|Change in renal progression measured by mean mGFR from week 7 to Month 36|Week 7, Week 52, Month 36|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).||mL/min/1.73m^2||Standard Deviation|Mean
760565|NCT00634920|Secondary|Calculated Glomerular Filtration Rate|The GFR was calculated according to the Modification of Diet in Renal Disease Study Group (MDRD) method, the Cockcroft-Gault method, and the Nankivell formula. cGFR was calculated from blood samples collected at predefined time points.|Months 12, 36|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).||mL/min/1.73m^2||Standard Deviation|Mean
760566|NCT00634920|Secondary|Measured Glomerular Filtration Rate|Progression of renal function measured by mean mGFR at 36 months after renal TX. The mGFR was measured using Iohexol or Cr-EDTA clearance according to local practice.|Month 36|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR). Patients who did not provide mGFR assessment at M36 visit were excluded from the analysis.||mL/min/1.73m^2||Standard Deviation|Mean
760567|NCT00634920|Primary|Measured Glomerular Filtration Rate|To compare the efficacy between treatment regimens by assessing the difference in renal function evaluated by mean measured glomerular filtration rate (mGFR) 12 months after renal transplantation (TX). The mGFR was measured using Iohexol or Cr-EDTA clearance according to local practice.|Month 12|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).||mL/min/1.73m^2||Standard Deviation|Mean
760568|NCT00634933|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28|The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to =<5.1 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1.|Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|mITT population included all randomized participants who received any portion of test article. LOCF method was used to impute missing values. Data for time points after Week 24 were not analyzed because of early termination of the study.||percentage of participants|||Number
760569|NCT00634933|Secondary|Work Productivity and Activity Impairment Questionnaire: Rheumatoid Arthritis (WPAI-RA) Score|WPAI-RA consisted of 6 items, a binary question on current employment, 3 questions on hours of work and work-loss, and 2 questions based on 0-10 point scale to judge how RA affects productivity at work and outside of work (0 = no effect on work and 10 = completely prevented from working). Four scores are derived: percent work time missed due to health, percent impairment while working due to health, percent overall work impairment due to health and percent activity impairment due to health. Total possible score range: 0 to 100, where 0 = no impairment and 100 = completely impaired.|Baseline, Week 12, 24, 36, 52|Data was not analyzed because development of TRU-015 was discontinued as results of primary analysis did not meet the predefined efficacy criteria.|||||
760570|NCT00634933|Secondary|Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score|FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant’s response to the questions (with the exception of 2 negatively stated), greater was the participant’s fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant’s response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score).|Baseline, Week 12, 24, 36, 52|Data was not analyzed because development of TRU-015 was discontinued as results of primary analysis did not meet the predefined efficacy criteria.|||||
760571|NCT00634933|Secondary|Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS)|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Week 12, 24, 36, 52|Data was not analyzed because development of TRU-015 was discontinued as results of primary analysis did not meet the predefined efficacy criteria.|||||
760572|NCT00634933|Secondary|Euro Quality of Life (EQ-5D)- Health State Profile Utility Score|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, confined to bed). Scoring formula developed by EuroQol Group assigns utility value for each domain in the profile. Score is transformed and results in total score range -0.594 to 1.000; higher score indicates a better health state."|Baseline, Week 12, 24, 36, 52|Data was not analyzed because development of TRU-015 was discontinued as results of primary analysis did not meet the predefined efficacy criteria.|||||
760573|NCT00634933|Secondary|36-Item Short-Form Health Survey (SF-36)|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline, Week 12, 24, 36, 52|Data was not analyzed because development of TRU-015 was discontinued as results of primary analysis did not meet the predefined efficacy criteria.|||||
760574|NCT00634933|Secondary|Disease Activity Score Based on 28-joints Count (DAS28)|DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and participant's general health visual analog scale (scores ranging 0 [very well] to 100 mm [extremely bad]). DAS28 less than or equal to (=<) 3.2 = low disease activity, DAS28 greater than (>) 3.2 to 5.1 = moderate to high disease activity.|Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|mITT population included all randomized participants who received any portion of test article. LOCF method was used to impute missing values. Data for time points after Week 24 were not analyzed because of early termination of the study.||units on a scale||Standard Deviation|Mean
760575|NCT00634933|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI)|HAQ-DI: participant-reported assessment of ability to perform tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) hygiene; and 8) common activities over past week. Each item scored on 4-point Likert scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. The overall disability index computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|mITT population included all randomized participants who received any portion of test article. LOCF method was used to impute missing values. Data for time points after Week 24 were not analyzed because of early termination of the study.||units on a scale||Standard Deviation|Mean
760576|NCT00634933|Secondary|General Health Visual Analog Scale (VAS)|"100 mm line (VAS) marked by participant. Participants were asked, How do you feel concerning your arthritis? Total possible score range, 0 mm = very well to 100 mm = extremely bad."|Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|Data was not analyzed because development of TRU-015 was discontinued as results of primary analysis did not meet the predefined efficacy criteria.|||||
760577|NCT00634933|Secondary|Patient Global Assessment (PtGA) of Disease Activity|Measured using a 0-10 point scale, where 0 = no disease activity and 10 = extreme disease activity.|Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|mITT population included all randomized participants who received any portion of test article. LOCF method was used to impute missing values. Data for time points after Week 24 were not analyzed because of early termination of the study.||units on a scale||Standard Deviation|Mean
760578|NCT00634933|Secondary|Physician Global Assessment (PGA) of Disease Activity|Physician Global Assessment of Disease Activity was measured on a 0 to 10 point scale, where 0 = no disease activity and 10 = extreme disease activity.|Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|mITT population included all randomized participants who received any portion of test article. LOCF method was used to impute missing values. Data for time points after Week 24 were not analyzed because of early termination of the study.||units on a scale||Standard Deviation|Mean
760579|NCT00634933|Secondary|Visual Analogue Scale for Pain (VAS-pain)|100 millimeter (mm) line (Visual Analog Scale) marked by participant. Intensity of pain range (over past week): 0 = no pain to 100 = worst possible pain.|Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|mITT population included all randomized participants who received any portion of test article. LOCF method was used to impute missing values. Data for time points after Week 24 were not analyzed because of early termination of the study.||mm||Standard Deviation|Mean
760580|NCT00634933|Secondary|Duration of Morning Stiffness|Duration of morning stiffness is defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (if none was present = 0; if morning stiffness was continuing, average of duration of stiffness over the past 3 days was reported; if stiffness persisted the entire day, 1440 minutes [24 hours*60 minutes] was recorded).|Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|Data was not analyzed because development of TRU-015 was discontinued as results of primary analysis did not meet the predefined efficacy criteria.|||||
760581|NCT00634933|Secondary|Number of Swollen Joints|The number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1.|Baseline. Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|mITT population included all randomized participants who received any portion of test article. LOCF method was used to impute missing values. Data for time points after Week 24 were not analyzed because of early termination of the study.||swollen joints||Standard Deviation|Mean
760615|NCT00635102|Secondary|Continuous Performance Task (CPT) - Distractibility A-Prime - 30 Minutes|gordon diagnostic system is a continuous performance task (CPT) to measure distractibility - (A-Prime score range 0 minimum - 1 maximum - the higher number the better the performance)|30 minutes|||units on a scale||Standard Deviation|Mean
760582|NCT00634933|Secondary|Number of Tender Joints|The number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.|Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|mITT population included all randomized participants who received any portion of test article. LOCF method was used to impute missing values. Data for time points after Week 24 were not analyzed because of early termination of the study.||tender joints||Standard Deviation|Mean
760583|NCT00634933|Secondary|Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response|ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (HAQ-DI); and CRP.|Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|mITT population included all randomized participants who received any portion of test article. LOCF method was used to impute missing values. Data for time points after Week 24 were not analyzed because of early termination of the study.||percentage of participants|||Number
760584|NCT00634933|Secondary|Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response|ACR50 response: >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (HAQ-DI); and CRP.|Week 2, 4, 8, 12, 16, 20, 28, 32, 36, 40, 44, 48, 52|mITT population included all randomized participants who received any portion of test article. LOCF method was used to impute missing values. Data for time points after Week 20 were not analyzed because of early termination of the study.||percentage of participants|||Number
760585|NCT00634933|Secondary|Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response|ACR20 response: >= 20% improvement in tender joint count; >= 20% improvement in swollen joint count; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (HAQ-DI); and CRP.|Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|mITT population included all randomized participants who received any portion of test article. LOCF method was used to impute missing values. Data for time points after Week 24 were not analyzed because of early termination of the study.||percentage of participants|||Number
760586|NCT00634933|Primary|Percentage of Participants With an American College of Rheumatology 50% (ACR 50) Response at Week 24|ACR50 response: greater than or equal to (>=) 50 percent (%) improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ-DI]); and C-Reactive Protein (CRP).|Week 24|Modified intent-to-treat (mITT) population included all randomized participants who received any portion of test article. Last observation carried forward (LOCF) method was used to impute missing values.||percentage of participants|||Number
760587|NCT00635024|Secondary|Number of Participants With Severe Non-hematological Adverse Events|Severe non-hematologic adverse events were defined as adverse events grade 3 or higher, regardless of attribution to study drug. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE version 3.0)|every month during treatment, up to 12 months|||participants|||Number
760588|NCT00635024|Secondary|Duration of Response (DOR)|DOR was calculated from the documentation of response (CR, VGPR or PR) until the date of progression in the subset of patients who responded.|up to 2 years|All patients are non-evaluable - no patients responded to treatment.|||||
760589|NCT00635024|Secondary|Progression-free Survival (PFS)|"PFS was defined as the time from registration to progression or death due to any cause.
Progression was defined as any one or more of the following:
An increase of 25% from lowest confirmed response in:
Serum M-component (absolute increase >= 0.5g/dl)
Urine M-component (absolute increase >= 200mg/24hour
Difference between involved and uninvolved Free Light Chain levels (absolute increase >= 10mg/dl)
Bone marrow plasma cell percentage (absolute increase of >=10%)
Definite development of new bone lesion or soft tissue plasmacytomas"|up to 2 years|||months||95% Confidence Interval|Median
760590|NCT00635024|Secondary|Overall Survival (OS)|OS was defined as the time from registration to death of any cause.|up to 2 years|||months||95% Confidence Interval|Median
760591|NCT00635024|Primary|Hematological Response Rate Defined as the Number of Participants Who Achieve a Confirmed Response|"Response that was confirmed on 2 consecutive evaluations during the first 4 months of treatment.
Complete Response(CR): Disappearance of M-protein from serum and urine, normalization of Free Light Chain (FLC) ratio and <5% plasma cells in bone marrow.
Very Good Partial Response(VGPR): >=90% reduction in serum M-component; Urine M-Component <100mg per 24hours.
Partial Response(PR): >=50% reduction in serum M-component and/or Urine M-Component >=90% reduction or <200mg per 24hours; or >=50% decrease in difference between involved and uninvolved FLC levels."|4 months|One participant was evaluable for the primary endpoint.||participants|||Number
760592|NCT00635050|Secondary|Assess Toxicities of Regimen Including Hand Foot Syndrome|patients who receive any treatment drugs will be included for toxicity evaluation. Adverse events will be summarized with frequencies and proportions of study participants exhibiting adverse events. The severity of adverse events (none, mild, moderate, severe) and their relationship to the product will be presented.|Baseline, every 2 weeks during treatment, and at completion of therapy. Every 3 weeks during postoperative Avastin|||participants|||Number
760593|NCT00635050|Secondary|Calculate Progression Free Survival|Progression free survival (PFS) will be defined as survival without local recurrence of breast cancer and without the development of distant metastasis. Death from any cause will be included as an event. The Kaplan-Meier nonparametric method will be used to estimate progression free survival.|5 years|operative specimens after treatment of participants||participants|||Number
760594|NCT00635050|Secondary|Number of Participant With Clinical or Subclinical Cardiotoxicity|Left ventricular ejection fraction (LVEF) measurements and clinical examination at baseline and at end of therapy will be used.|Prior to treatment and at completion of chemotherapy|||participants|||Number
760595|NCT00635050|Primary|Rate of Achievement of Pathological Complete Response (pCR)|Results of the pathologic evaluation of the surgical specimen(s) from operation (segmental or total mastectomy) will be used to report the overall complete pathological response rate. Criteria used were those described by Kaufmann et al, Journal of Clinical Oncology 2003; 21(13):2600-2608. The definition of pCR used from this source was absence of invasive cancer in both resected breast tissue and in resected axillary nodes.|After completion of at least 8 of the 9 chemotherapy doses and operation.|Intention to treat, i.e., all participants entered were included in the analysis.||pathology specimens from participants|||Number
760596|NCT00635089|Secondary|Number of Participants With >/= 1 Confirmed Positive Value for Anti-drug Antibodies (ADA)|Using a validated enzyme-linked immunosorbent assay (ELISA), the number of participants who had at least 1 confirmed positive value for ADA, either on day 0 after having received reslizumab in the double-blind study Res-05-0002 (NCT00538434) or during the course of the open-label study.|From start of study drug until end of treatment (mean [SD] duration of treatment was 30.0 [5.89] months)|Participants with an assessment.||participants|||Number
760597|NCT00635089|Secondary|Reslizumab Serum Concentrations|Reslizumab serum concentrations obtained in this study were included in ongoing and separate population pharmacokinetic analyses. The Number of Participants Analyzed reflects the number of participants who had concentrations measured following that dose level. Since some participants started on 1 mg/kg and later increased to 2 mg/kg (and are therefore represented in more than one column), the number of participants in each column add up to a greater number than the total in the overall column, which reflects the total number of participants with measurable concentration data in this study. The number of concentrations summarized for that dose level represents more than one concentration per participant in most cases.|Before treatment (within 3 hours) and after treatment (within 3 hours after end of infusion) for doses at Weeks 8 and 12; within 6 days after either dose at Weeks 8 or 12; 2 to 4 weeks after dose at Weeks 8 or 12; and at premature withdrawal.|Number of participants with measurable concentration data at each dose level and overall.||µg/mL|Concentrations|Standard Deviation|Mean
760598|NCT00635089|Secondary|Dietary Question Responses at Endpoint|Number of participants answering that they either maintained or changed their diet from the beginning of the double-blind study (ie, NCT00538434). Additionally, for those participants who answered that they changed their diet from the beginning of the double-blind study (column 2), the number of participants in that group who changed by increasing the consistency of their food ('Increased consistency') and the percentage that changed by eating foods that previously worsened EoE ('Added foods'). (Note that these 2 categories are not mutually exclusive, so that someone could have both increased the consistency of the food they were eating AND also eaten foods that previously worsened their EoE symptoms.)|Study endpoint (mean [SD] duration of treatment was 30.0 [5.89] months)|Number of Participants Analyzed=all participants (n=190). The denominator for follow-up questions is the number of participants responding ‘No’ to the question “Have you maintained your diet since the beginning of the study?” (n=63).||participants|||Number
760599|NCT00635089|Secondary|Mean Change From Baseline to Endpoint in Selected Child Health Questionnaire (CHQ) Scores|The Child Health Questionnaire comprises 50 items. Specific items are recoded and/or recalibrated. Raw scores for scales (domains calculated over one or more items) are then calculated following set algorithms. The raw scales are then transformed to 0 to 100 scores, except for Change in Health which remains a 1-5 score. Finally two summary measures are calculated based on weighted combinations of selected scales. The Global Health, Physical Summary Score and Psychosocial Summary Score were summarized. For each, scores range from 0 (higher disease activity) to 100 (lower disease activity); higher scores indicate better health.|Baseline through Endpoint (last visit; mean [SD] duration of treatment was 30.0 [5.89] months)|n=participants with an assessment for the given score at Baseline and Endpoint.||units on a scale||Standard Deviation|Mean
760600|NCT00635089|Secondary|Physician's EoE Global Assessment Over Time|The data from the participant’s/parent’s EoE Symptom Assessment, in combination with other observations, were used by physicians to determine the Physician’s EoE Global Assessment. All components of the patient’s EoE Symptom Assessment were used by physicians to determine the Physician’s EoE Global Assessment.|Every 3 weeks from Day 0 up to Week 42 (mean [SD] duration of treatment was 30.0 [5.89] months)|The statistical analysis plan only specified that data would be summarized/described graphically for visual inspection and cannot be summarized.|||||
760601|NCT00635089|Secondary|Participant's EoE Predominant Symptoms Over Time|The data from the patient’s/parent’s eosinophilic esophagitis (EoE) Symptom Assessment were used to assess the shift from baseline in Predominant Symptom Assessment. The predominant symptom of the participant’s/parent’s EoE Symptom Assessment was selected at the double-blind baseline visit and remained the same throughout this study. Using the EoE Symptom Assessment, the participant/parent or legal guardian rated the severity of the previous week’s EoE symptoms as none, mild, moderate, severe, or very severe on a 5-point scale. Only the predominant symptom selected for each participant contributed to the overall analysis of the Predominant Symptom Assessment and the subgroup analyses of individual symptoms. Thus, for the Predominant Symptom Analysis, some patients had dysphagia assessed, while others had either abdominal/chest pain or vomiting/regurgitation assessed.|Every 3 weeks from Day 0 up to Week 42 (mean [SD] duration of treatment was 30.0 [5.89] months)|The statistical analysis plan only specified that data would be summarized/described graphically for visual inspection and cannot be summarized.|||||
760602|NCT00635089|Primary|Therapeutic Classification of Concomitant Medications in at Least 10% of Participants|Number of participants receiving therapeutic classes of concomitant medications.|From start of study drug until end of treatment (mean [SD] duration of treatment was 30.0 [5.89] months)|||participants|||Number
760616|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Reduced Control of Alcohol Use - 120 Minutes|Alcohol Craving Scale (ACS) Subscale: Self-report rating scale used to measure reduced control of alcohol (0 Not at all - 100 Definitely)|120 minutes|||units on a scale||Standard Deviation|Mean
760617|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Reduced Control of Alcohol Use - 60 Minutes|Alcohol Craving Scale (ACS) Subscale: Self-report rating scale used to measure reduced control of alcohol (0 Not at all - 100 Definitely)|60 minutes|||units on a scale||Standard Deviation|Mean
760618|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Reduced Control of Alcohol Use - 30 Minutes|Alcohol Craving Scale (ACS) Subscale: Self-report rating scale used to measure reduced control of alcohol (0 Not at all - 100 Definitely)|30 minutes|||units on a scale||Standard Deviation|Mean
760603|NCT00635089|Primary|Infusion Site Evaluations|The infusion site was assessed before treatment and within 30 minutes after the end of the infusion at each monthly treatment visit (or at early withdrawal if before Week 16). The infusion site was graded according to a 5-point scale as follows: 0=no tenderness at IV site, no erythema, no swelling, no induration, no purulence, no palpable venous cord; 1=tender IV site, no erythema, no swelling, no induration, no purulence, no palpable venous cord; 2=tender IV site with erythema, some degree of swelling, no induration, no purulence, no palpable venous cord; 3=tender IV site with erythema and swelling, with induration or palpable venous cord, no purulence; 4=frank vein thrombosis, along with all signs of grade 3 with purulence; IV may stop running because of thrombosis. After the 16-week visit, formal infusion site evaluations were not continued. However, any infusion site reactions were recorded as adverse events and graded as other adverse events.|Day 0, Weeks 4, 8, 12, 16, endpoint (last visit), any time during study (mean [SD] duration of treatment was 30.0 [5.89] months)|Number of Participants Analyzed= all participants in study (n=190); n=number of participants graded at given time point.||participants|||Number
760604|NCT00635089|Primary|Number of Participants With Newly Diagnosed Physical Examination Abnormalities at Endpoint|HEENT=head, eyes, ears, nose and throat.|From start of study drug until end of treatment (mean [SD] duration of treatment was 30.0 [5.89] months)|||participants|||Number
760605|NCT00635089|Primary|Number of Participants With at Least 1 Potentially Clinically Significant Abnormal Vital Signs Value|Low systolic blood pressure: < 90 and decrease (↓) of 30 mm Hg from baseline (BL) (ages 5-18); high systolic blood pressure: > 160 and increase (↑) of 30 mm Hg from BL (age 5-12), > 130 and ↑ of 30 mm Hg from BL (age 13-18). Low diastolic blood pressure: < 45 and ↓ of 12 mm Hg from BL (age 5-12), < 55 and ↓ of 12 mm Hg from BL (age 13-18), < 50 and ↓ of 15 mm Hg from BL; high diastolic blood pressure: > 85 and ↑ of 12 mm Hg from BL (ages 5-18). Low heart rate: < 80 and and ↓ of 30 beats per minute (bpm) from BL (age 5-12), < 60 and and ↓ of 30 bpm from BL (age 13-18), < 50 and and ↓ of 15 bpm from BL (age > 18); high heart rate: > 120 and ↑ of 30 bpm from BL (age 5-12), > 100 and ↑ of 30 bpm from BL (age 13-18), > 100 and ↑ of 15 bpm from BL (age > 18). Low oral body temperature: < 35.8° Celsius (age 5 to >18); high oral body temperature: > 38.1° C and ↑ 2° Celsius from BL (age 5-18).|From start of study drug until end of treatment (mean [SD] duration of treatment was 30.0 [5.89] months)|||participants|||Number
760606|NCT00635089|Primary|Number of Participants With at Least 1 Potentially Clinically Significant Abnormal Serum Chemistry Laboratory Test Results or Urinalysis Abnormality|Serum chemistry laboratory tests performed include: calcium, phosphorus, magnesium, sodium, potassium, chloride, creatinine, glucose [nonfasting], blood urea nitrogen, total cholesterol, uric acid, alanine aminotransferase, aspartate aminotransferase, lactate dehydrogenase, gamma glutamyl transpeptidase, alkaline phosphatase, bicarbonate, creatine kinase, total protein, albumin, total bilirubin, direct bilirubin, indirect bilirubin. Urinalysis tests performed include: protein, glucose, ketones, bilirubin, urobilinogen, nitrite content, pH, specific gravity, white blood cells, microscopic (red blood cells, white blood cells, casts, crystals).|From start of study drug until end of treatment (mean [SD] duration of treatment was 30.0 [5.89] months)|||participants|||Number
760607|NCT00635089|Primary|Number of Participants With at Least 1 Potentially Clinically Significant Abnormal Hematology Value|Hematology laboratory tests performed include: hemoglobin, hematocrit, red blood cell count, mean cell volume, mean cell hemoglobin, mean cell hemoglobin concentration, platelet count, white blood cell count, and differential count and percentage (polymorphonuclear leukocytes [neutrophils], lymphocytes, eosinophils, monocytes, basophils, platelets).|From start of study drug until end of treatment (mean [SD] duration of treatment was 30.0 [5.89] months)|Participants with a postbaseline result for hematology tests.||participants|||Number
760608|NCT00635089|Secondary|Mean Change From Baseline to Endpoint in Peak Esophageal Eosinophil Counts|The mean change from baseline in esophageal eosinophil levels was described at week 16 or early withdrawal (if before week 16), using descriptive statistics. Baseline was defined as the last assessment before the first dose of reslizumab, which was the baseline of the double-blind study (NCT00538434) for patients who received reslizumab in the double blind study or the baseline of the open-label study for patients who received placebo during the double-blind study.|Baseline, Week 16 or early withdrawal (if before Week 16)|Participants with an assessment at Baseline and Week 16 (or early withdrawal).||eosinophils/high power field (hpf)||Standard Deviation|Mean
760609|NCT00635089|Primary|Number of Participants With Treatment-emergent Adverse Events (AEs), Serious AEs, or Discontinuation Due to AEs|An AE was defined as any adverse experience, including side effect, injury, toxicity, sensitivity reaction, intercurrent illness, or sudden death, whether or not it was considered related to the use of study drug. Treatment emergent adverse events were those that started any time after the administration of the first dose of study drug (at baseline of this study) and before the cessation of study drug. Serious adverse events that occurred any time after the administration of the first dose of study drug until 30 days after administration of the last dose of study drug were reported as treatment emergent serious adverse events.|From start of study drug until end of treatment (mean [standard deviation {SD}] duration of treatment was 30.0 [5.89] months)|Three additional participants experiences anaphylactic reactions that were upgraded to serious AEs after database lock. These 3 participants are not included in this table summary.||participants|||Number
760610|NCT00635102|Secondary|Hopkins Verbal Learning Task - Delay Recall - 90 Minutes|Hopkins Verbal Learning Task (HVLT) - measures verbal memory and hippocampus function. (delay recall - 30 minutes after Trials 1-3 were given) (0 No words recalled - 12 all words recalled)|90 minutes|||units on a scale||Standard Deviation|Mean
760611|NCT00635102|Secondary|Hopkins Verbal Learning Task - Immediate Recall - 60 Minutes - Trial 3|Hopkins Verbal Learning Task (HVLT) - measures verbal memory and hippocampus function. (Three immediate recall trials) (0 No words recalled - 12 all words recalled)|60 minutes - Trial 3|||units on a scale||Standard Deviation|Mean
760612|NCT00635102|Secondary|Hopkins Verbal Learning Task - Immediate Recall - 60 Minutes - Trial 2|Hopkins Verbal Learning Task (HVLT) - measures verbal memory and hippocampus function. (Three immediate recall trials) (0 No words recalled - 12 all words recalled)|60 minutes - Trial 2|||units on a scale||Standard Deviation|Mean
760613|NCT00635102|Secondary|Hopkins Verbal Learning Task - Immediate Recall - 60 Minutes - Trial 1|Hopkins Verbal Learning Task (HVLT) - measures verbal memory and hippocampus function. (Three immediate recall trials) (0 No words recalled - 12 all words recalled)|60 minutes - Trial 1|||units on a scale||Standard Deviation|Mean
760619|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Reduced Control of Alcohol Use - 60 Minutes Prior to Glycine Infusion|Alcohol Craving Scale (ACS) Subscale: Self-report rating scale used to measure reduced control of alcohol (0 Not at all - 100 Definitely)|60 minutes prior to Glycine infusion|||units on a scale||Standard Deviation|Mean
760620|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Reduced Control of Alcohol Use - Baseline|Alcohol Craving Scale (ACS) Subscale: Self-report rating scale used to measure reduced control of alcohol (0 Not at all - 100 Definitely)|Baseline|||units on a scale||Standard Deviation|Mean
760621|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Discomfort - 120 Minutes|Alcohol Craving Scale (ACS) Subscale: Discomfort: Self-report rating scale - subscale reflecting expected alcohol-related relief from discomfort (0 Not at all - 100 Definitely)|120 minutes|||units on a scale||Standard Deviation|Mean
760622|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Discomfort - 60 Minutes|Alcohol Craving Scale (ACS) Subscale: Discomfort: Self-report rating scale - subscale reflecting expected alcohol-related relief from discomfort (0 Not at all - 100 Definitely)|60 minutes|||units on a scale||Standard Deviation|Mean
760623|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Discomfort - 30 Minutes|Alcohol Craving Scale (ACS) Subscale: Discomfort: Self-report rating scale - subscale reflecting expected alcohol-related relief from discomfort (0 Not at all - 100 Definitely)|30 minutes|||units on a scale||Standard Deviation|Mean
760624|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Discomfort - 60 Minutes Prior to Glycine Infusion|Alcohol Craving Scale (ACS) Subscale: Discomfort: Self-report rating scale - subscale reflecting expected alcohol-related relief from discomfort (0 Not at all - 100 Definitely)|60 minutes prior to Glycine infusion|||units on a scale||Standard Deviation|Mean
760625|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Discomfort - Baseline|Alcohol Craving Scale (ACS) Subscale: Discomfort: Self-report rating scale - subscale reflecting expected alcohol-related relief from discomfort (0 Not at all - 100 Definitely)|Baseline|||units on a scale||Standard Deviation|Mean
760626|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Mood Improvement - 120 Minutes|Alcohol Craving Scale (ACS) Subscale: Mood improvement : Self-report rating scale used to measure expected alcohol-related mood improvement (0 Not at all - 100 Definitely)|120 minutes|||units on a scale||Standard Deviation|Mean
760627|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Mood Improvement - 60 Minutes|Alcohol Craving Scale (ACS) Subscale: Mood improvement : Self-report rating scale used to measure expected alcohol-related mood improvement (0 Not at all - 100 Definitely)|60 minutes|||units on a scale||Standard Deviation|Mean
760628|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Mood Improvement - 30 Minutes|Alcohol Craving Scale (ACS) Subscale: Mood improvement : Self-report rating scale used to measure expected alcohol-related mood improvement (0 Not at all - 100 Definitely)|30 minutes|||units on a scale||Standard Deviation|Mean
760629|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Mood Improvement - 60 Minutes Prior to Glycine Infusion|Alcohol Craving Scale (ACS) Subscale: Mood improvement : Self-report rating scale used to measure expected alcohol-related mood improvement (0 Not at all - 100 Definitely)|60 minutes prior to Glycine infusion|||units on a scale||Standard Deviation|Mean
760630|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Mood Improvement - Baseline|Alcohol Craving Scale (ACS) Subscale: Mood improvement : Self-report rating scale used to measure expected alcohol-related mood improvement (0 Not at all - 100 Definitely)|Baseline|||units on a scale||Standard Deviation|Mean
760631|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Desire to Drink - 120 Minutes|Alcohol Craving Scale (ACS) Subscale: Desire to drink: Self-report rating scale used to measure desire to drink alcohol (0 No desire to drink alcohol - 100 Definitely desire to drink alcohol)|120 minutes|||units on a scale||Standard Deviation|Mean
760632|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Desire to Drink - 60 Minutes|Alcohol Craving Scale (ACS) Subscale: Desire to drink: Self-report rating scale used to measure desire to drink alcohol (0 No desire to drink alcohol - 100 Definitely desire to drink alcohol)|60 minutes|||units on a scale||Standard Deviation|Mean
760633|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Desire to Drink: - 30 Minutes|Alcohol Craving Scale (ACS) Subscale: Desire to drink: Self-report rating scale used to measure desire to drink alcohol (0 No desire to drink alcohol - 100 Definitely desire to drink alcohol)|30 minutes|||units on a scale||Standard Deviation|Mean
760634|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Desire to Drink - 60 Minutes Prior to Glycine Infusion|Alcohol Craving Scale (ACS) Subscale: Desire to drink: Self-report rating scale used to measure desire to drink alcohol (0 No desire to drink alcohol - 100 Definitely desire to drink alcohol)|60 minutes prior to Glycine infusion|||units on a scale||Standard Deviation|Mean
760635|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Desire to Drink- Baseline|Alcohol Craving Scale (ACS) Subscale: Desire to drink: Self-report rating scale used to measure desire to drink alcohol (0 No desire to drink alcohol - 100 Definitely desire to drink alcohol)|Baseline|||units on a scale||Standard Deviation|Mean
760636|NCT00635102|Secondary|Visual Analog Scales (VAS) - 120 Minutes|Visual Analog Scales (VAS): Self-report rating scale used to measure high (0 not at all - 7 extremely)|120 minutes|||units on a scale||Standard Deviation|Mean
760637|NCT00635102|Secondary|Visual Analog Scales (VAS) - 60 Minutes|Visual Analog Scales (VAS): Self-report rating scale used to measure high (0 not at all - 7 extremely)|60 minutes|||units on a scale||Standard Deviation|Mean
760638|NCT00635102|Secondary|Visual Analog Scales (VAS) - 30 Minutes|Visual Analog Scales (VAS): Self-report rating scale used to measure high (0 not at all - 7 extremely)|30 minutes|||units on a scale||Standard Deviation|Mean
760639|NCT00635102|Secondary|Visual Analog Scales (VAS) - 60 Minutes Prior to Glycine Infusion|Visual Analog Scales (VAS): Self-report rating scale used to measure high (0 not at all - 7 extremely)|60 minutes prior to Glycine infusion|||units on a scale||Standard Deviation|Mean
760640|NCT00635102|Secondary|Visual Analog Scales (VAS) - Baseline|Visual Analog Scales (VAS): Self-report rating scale used to measure high (0 not at all - 7 extremely)|Baseline|||units on a scale||Standard Deviation|Mean
760641|NCT00635102|Secondary|Biphasic Alcohol Effects Scale (BAES) Subscale Sedation - 120 Minutes|Self-report rating scale used to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol|120 minutes|Self-report rating scale used to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol||units on a scale||Standard Deviation|Mean
760642|NCT00635102|Secondary|Biphasic Alcohol Effects Scale (BAES) Subscale Sedation - 60 Minutes|Self-report rating scale used to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol|60 minutes|Self-report rating scale used to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol||units on a scale||Standard Deviation|Mean
760643|NCT00635102|Secondary|Biphasic Alcohol Effects Scale (BAES) Subscale Sedation - 30 Minutes|Self-report rating scale used to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol|30 minutes|Self-report rating scale used to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol||units on a scale||Standard Deviation|Mean
760644|NCT00635102|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Sedation 60 Minutes Prior to Glycine Infusion|Self-report rating scale used to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol|60 minutes prior to Glycine infusion|Self-report rating scale used to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol||units on a scale||Standard Deviation|Mean
760645|NCT00635102|Secondary|Biphasic Alcohol Effects Scale (BAES) Subscale Sedation - Baseline|Self-report rating scale used to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol|Baseline|Self-report rating scale used to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol||units on a scale||Standard Deviation|Mean
760646|NCT00635102|Secondary|Number of Drinks Felt Consumed at 120 Minutes|The Number of Drinks Scale asks subjects to report on the number of alcoholic drinks they felt they had consumed.|120 minutes|The Number of Drinks Scale asks subjects to report on the number of alcoholic drinks they felt they had consumed.||Number of Drinks Felt Consumed||Standard Deviation|Mean
760647|NCT00635102|Secondary|Number of Drinks Felt Consumed at 60 Minutes|The Number of Drinks Scale asks subjects to report on the number of alcoholic drinks they felt they had consumed.|60 minutes|The Number of Drinks Scale asks subjects to report on the number of alcoholic drinks they felt they had consumed.||Number of Drinks Felt Consumed||Standard Deviation|Mean
760648|NCT00635102|Secondary|Number of Drinks Felt Consumed at 30 Minutes|The Number of Drinks Scale asks subjects to report on the number of alcoholic drinks they felt they had consumed.|30 minutes|The Number of Drinks Scale asks subjects to report on the number of alcoholic drinks they felt they had consumed.||Number of Drinks Felt Consumed||Standard Deviation|Mean
760649|NCT00635102|Secondary|Number of Drinks Felt Consumed at 60 Minutes Prior to Glycine Infusion|The Number of Drinks Scale asks subjects to report on the number of alcoholic drinks they felt they had consumed.|60 minutes prior to Glycine infusion|The Number of Drinks Scale asks subjects to report on the number of alcoholic drinks they felt they had consumed.||drinks felt consumed||Standard Deviation|Mean
760650|NCT00635102|Primary|Visual Analog Scales of Similarity to Alcohol 120 Minutes|Visual Analog Scales of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol –7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|120 minutes|Visual Analog Scales of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol –7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol||units on a scale||Standard Deviation|Mean
760651|NCT00635102|Primary|Visual Analog Scales of Similarity to Alcohol 60 Minutes|Visual Analog Scales of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol –7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|60 minutes|Visual Analog Scales of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol –7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol||units on a scale||Standard Deviation|Mean
760652|NCT00635102|Primary|Visual Analog Scales of Similarity to Alcohol 30 Minutes|Visual Analog Scales of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol –7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|30 minutes|Visual Analog Scales of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol –7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol||units on a scale||Standard Deviation|Mean
760653|NCT00635102|Primary|Visual Analog Scales of Similarity to Alcohol 60 Minutes Prior to Glycine Infusion|Visual Analog Scales of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol –7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|60 minutes prior to Glycine infusion|Visual Analog Scales of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol –7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol||units on a scale||Standard Deviation|Mean
760654|NCT00635102|Primary|Visual Analog Scales of Similarity to Alcohol - Baseline|Visual Analog Scales of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol –7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|Baseline|Visual Analog Scales of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol –7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol||units on a scale||Standard Deviation|Mean
760655|NCT00635128|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Assessed SAEs include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire booster period (Month 0 to Month 1)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.||Participants|||Count of Participants
760656|NCT00635128|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|AEs results are presented for all subjects. An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Days 0–30) follow-up period after booster vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.||Participants|||Count of Participants
760701|NCT00635882|Secondary|Change From Baseline in AM Peak Expiratory Flow (PEF) at Days 2-15||Baseline and Days 2-15|All randomized participants||liters/minute||Standard Deviation|Mean
787454|NCT00844194|Secondary|Suicidal Thoughts by BDI-II at Week 2||Week 2|All patients receiving at least one dose of study medication and having data at week 2.||Participants|||Number
760657|NCT00635128|Secondary|Number of Subjects With Booster Response to Anti-PT, Anti-FHA and Anti-PRN|Booster vaccine response was defined as appearance of antibodies in subjects who were seronegative at the pre-vaccination time point (i.e. with concentrations < 5 EL.U/mL) or at least 2-fold increase of pre-vaccination antibody concentrations in subjects who were seropositive at the pre-vaccination time point (i.e. with concentrations < 5 EL.U/mL).|One month after booster vaccination (At Month 1)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects vaccinated with a booster dose of Boostrix™-Polio vaccine in this current study (110947), for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.||Participants|||Count of Participants
760658|NCT00635128|Secondary|Anti-Polio 1, 2 and 3 Antibody Titers|Antibody titers were presented as geometric mean titers (GMTs).|Prior to (Month 0) and one month after (Month 1) booster vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects vaccinated with a booster dose of Boostrix™-Polio vaccine in this current study (110947), for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.||Titers||95% Confidence Interval|Geometric Mean
760659|NCT00635128|Secondary|Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Antigens|A seroprotected subject was defined as a subject with anti-Polio type 1, 2 and 3 antibody titers ≥ the value of 8.|Prior to (Month 0) and one month after (Month 1) booster vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects vaccinated with a booster dose of Boostrix™-Polio vaccine in this current study (110947), for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.||Participants|||Count of Participants
760660|NCT00635128|Secondary|Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations|Antibodies concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.|Prior to (Month 0) and one month after (Month 1) booster vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects vaccinated with a booster dose of Boostrix™-Polio vaccine in this current study (110947), for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
760661|NCT00635128|Secondary|Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)|A seropositive subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 ELISA unit per milliliter (EL.U/ml).|Prior to (Month 0) and one month after (Month 1) booster vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects vaccinated with a booster dose of Boostrix™-Polio vaccine in this current study (110947), for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.||Participants|||Count of Participants
760662|NCT00635128|Secondary|Anti-D and Anti-T Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).|Prior to (Month 0) and one month after (Month 1) booster vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects vaccinated with a booster dose of Boostrix™-Polio vaccine in this current study (110947), for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.||IU/mL||95% Confidence Interval|Geometric Mean
760663|NCT00635128|Secondary|Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Toxoids|Anti-D and anti-T antibody concnetration greater than or equal to (≥) 0.1 international units per milliliter (IU/mL) and ≥ 1 IU/mL have been assessed by enzyme-linked immunosorbent assay (ELISA). Pre-vaccination sera with ELISA concentrations < 0.1 IU/mL were tested for neutralising antibodies using a Vero-cell neutralisation assay with a 0.016 IU/mL cut-off.|Prior to (Month 0) and one month after (Month 1) booster vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects vaccinated with a booster dose of Boostrix™-Polio vaccine in this current study (110947), for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.||Participants|||Count of Participants
760664|NCT00635128|Secondary|Number of Subjects With Any Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal, headache and temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade and relationship to vaccination.|During the 4-day (Days 0–3) follow-up period after booster vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available and who had the symptoms sheet filled in.||Participants|||Count of Participants
760665|NCT00635128|Secondary|Number of Subjects With Any Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.|During the 4-day (Days 0-3) follow-up period after booster vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.||Participants|||Count of Participants
760666|NCT00635128|Primary|Number of Subjects With Any Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Grade 3 Pain: Pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.|During the 4-day (Days 0-3) follow-up period after booster vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.||Participants|||Count of Participants
760667|NCT00635154|Secondary|Duration of Response|Duration of response is defined for all evaluable participants (receiving Anakinra alone or in combination with Dexamethasone) who have achieved an objective response as the date at which the participants status was first noted to be MR or better to the date progression is documented or the date of last follow-up.|From first documentation of response to progression or last follow-up (up to 5 years)|Participants (receiving Anakinra alone or in combination with Dexamethasone) who achieved a MR or better were analyzed.||months||95% Confidence Interval|Median
761448|NCT00640315|Secondary|Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Mean Arterial Pressure (MAP)|MAP was acquired during right heart catheterization|From baseline up to 4 hours after administration|per-protocol population||mmHg||Standard Deviation|Mean
760668|NCT00635154|Secondary|Number of Patients With Severe Non-hematological Adverse Events in Participants Receiving Anakinra in Combination With Dexamethasone|Severe non-hematologic adverse events were defined as adverse events grade 4 (life threatening or disabling) or grade 5 (death), regardless of attribution to study drug. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) version 2.|every cycle during treatment (up to 5 years)|Only participants who received Anakinra with low or high dose dexamethasone were analyzed.||participants|||Number
760669|NCT00635154|Secondary|Progression Free Survival (PFS) in Patients Treated With Anakinra Alone or in Combination With Dexamethasone|"PFS was defined as the time from registration to progression or death due to any cause.
Progression is defined the same as outcome measure #3."|Time from registration to progression or death (up to 5 years)|PFS results were published in Mayo Clin Proc, Feb 2009. 47 patients were analyzed for this publication.||months||95% Confidence Interval|Median
760670|NCT00635154|Secondary|Number of Patients With Severe Non-hematological Adverse Events in Patients Receiving Anakinra Alone or in Combination With Dexamethasone.|Severe non-hematologic adverse events were defined as adverse events grade 4 (life threatening or disabling) or grade 5 (death), regardless of attribution to study drug. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) version 2.|Duration of treatment (up to 5 years)|||participants|||Number
760671|NCT00635154|Secondary|Number of Patients Who Are Progression-free and Alive at 6 Months|"Disease stability was assessed by evaluating the proportion of participants who are progression free (and alive) at 6 months.
Progression was defined as any one or more of the following:
An increase of 25% from lowest confirmed response:
Serum M-component (absolute increase >=1.0 g/dL)
Urine M-component (absolute increase >=200 mg/24 hours)
An increase of 50% above the lowest remission value in bone marrow plasmacytosis (absolute increase 25% bone marrow plasma cells)
Development of new bone lesions or soft tissue plasmacytomas."|at 6 months|||participants|||Number
760672|NCT00635154|Secondary|Number of Patients With Response to Treatment With Dexamethasone and Anakinra|"Response on 2 consecutive months during active treatment with anakinra alone or in combination with dexamethasone.
Response criteria is the same as in Primary Outcome Measure."|During Active treatment (up to 5 years)|Only participants who received Anakinra with dexamethasone were analyzed.||participants|||Number
760673|NCT00635154|Primary|Patients With Confirmed Response (Complete Response, Very Good Partial Response, Partial Response, or Minimal Response) on 2 Consecutive Months During the First 6 Months of Treatment With Anakinra Alone|"Response Definitions:
Complete Response(CR):disappearance of M-Protein from serum & urine and immunofixation, <5% bone marrow(BM) plasma cells & disappearance of soft tissue plasmacytomas(STP);
Very Good Partial Response(VGPR):>=90% decrease in serum M-Protein, Urine M-protein <100 mg/24 hours, <=5% BM plasma cells, disappearance of STP;
Partial response(PR):>=50% reduction in serum M-protein, >=90% decrease in Urine M-protein or <200 mg/24 hours & >=50% decrease in STP;
Minor response(MR):25-49% decrease in serum M-protein, 50-89% decrease in urine M-protein & 25-49% decrease in STP"|6 months|Participants who met the eligibility criteria, signed the consent form and have began treatment were considered evaluable.||participants|||Number
760674|NCT00635661|Primary|Stroke Rehabilitation Assessment of Movement (STREAM)|The STREAM measures quality of movements in the arm and leg, and the quality of mobility during important functional tasks, such as walking 10 feet. There are 10 items for each of the 3 assessments (arm, leg and mobility), resulting in a total of 30 items. Each item is rated on a scale of 0 = unable to perform, to 2 or 3 = normal movement. Ratings on the 30 items are added together for a total score which is divided by the total number of items resulting in a percentage score: minimum=0, maximum=100, range=100 The score reported is mean +/- standard deviation of discharge STREAM scores.|4 weeks|34 participants were enrolled, 4 participants were dropped from the study resulting in 30 participants providing data for analysis.||units on a scale||Standard Deviation|Mean
760675|NCT00635700|Secondary|Improvement SOPS Total Score||8 weeks||||||
760676|NCT00635700|Primary|Conversion to Psychosis|Conversion to psychosis according to the SIPS require psychotic symptom severity ratings in the frankly psychotic range, along with meeting persistence or urgency criteria.|6 months|In another case assigned to active ziprasidone, ratings conducted at a follow-up conversion visit suggested retrospectively that the patient had been already psychotic prior to enrollment. The study’s blinded DSMB was consulted, and in a split 4-2 vote recommended retaining the patient as randomized in the primary analysis.||participants|||Number
760677|NCT00635804|Secondary|Maximum HCV Viral Load Change From Baseline Over Study Following MK-3281 Dosing For 7 Days|For evaluation of MK-3281 antiviral activity, the maximum reduction in HCV ribonucleic acid (RNA) levels over the course of the study was assessed by MK-3281 dose group in HCV+ participants and the mean maximum viral load reduction was summarized. HCV RNA levels were measured at predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 hours postdose on Day 1 and Day 7; pre-morning (AM) and pre-evening (PM) dose Day 2; and pre AM dose Days 3-6. For each participant, baseline measurement was defined as the measurement obtained pre-dose on the first day of dosing, and change from baseline (difference) was calculated at each time point. The response for that participant was defined as: − (postbaseline time point − baseline) at the time point with the lowest HCV RNA level.|Baseline (pre-dose Day 1), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7|Treated HCV+ participants in Part II with available HCV RNA data. 800 mg dose group contained members of Panels E and F. No healthy participants from Part 1 (Panels A, B, C, or D) were assessed for this outcome measure.||log(IU/ml)||95% Confidence Interval|Mean
760678|NCT00635804|Secondary|C12hr Accumulation Ratio of MK-3281|Blood samples were obtained from participants and the MK-3281 C12hr accumulation ratio was calculated for HCV+ participants and healthy participants. C12hr accumulation ratio calculated for healthy participants as Day 10 C12hr / Day 1 C12hr. C12hr accumulation ratio calculated for HCV+ participants as Day 7 C12hr / Day 1 C12hr.|Predose daily on Days 2-9 (for healthy participants) and Days 2-6 (for HCV+ participants), and predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 1, Day 7 (HCV+ participants), and Day 10 (healthy participants)|All Treated Participants with available PK data. Participants in the Placebo group did not receive MK-3281 and therefore did not have PK data reported.||ratio||90% Confidence Interval|Geometric Mean
760725|NCT00636194|Secondary|Graded Slit Lamp Findings > Grade 2|Grade none (no findings) - grade 4 (severe findings). Eyes in the Test group were compared with eyes in the Control group. Slit lamp finding greater than Grade 2.|2 week follow-up visit|All dispensed, completed eyes||eyes|Participants||Number
760679|NCT00635804|Secondary|Cmax Accumulation Ratio of MK-3281|Blood samples were obtained from participants and the MK-3281 Cmax accumulation ratio was calculated for HCV+ participants and healthy participants. Cmax accumulation ratio calculated for healthy participants as Day 10 Cmax / Day 1 Cmax. Cmax accumulation ratio calculated for HCV+ participants as Day 7 Cmax / Day 1 Cmax.|Predose daily on Days 2-9 (for healthy participants) and Days 2-6 (for HCV+ participants), and predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 1, Day 7 (HCV+ participants), and Day 10 (healthy participants)|All Treated Participants with available PK data. Participants in the Placebo group did not receive MK-3281 and therefore did not have PK data reported.||ratio||90% Confidence Interval|Geometric Mean
760680|NCT00635804|Secondary|AUC (0-12hr) Accumulation Ratio of MK-3281|Blood samples were obtained from participants and the MK-3281 AUC(0-12hr) accumulation ratio was calculated for HCV+ participants and healthy participants. AUC(0-12hr) accumulation ratio calculated for healthy participants as Day 10 AUC (0-12hr) / Day 1 AUC (0-12hr). AUC(0-12hr) accumulation ratio calculated for HCV+ participants as Day 7 AUC (0-12hr) / Day 1 AUC (0-12hr).|Predose daily on Days 2-9 (for healthy participants) and Days 2-6 (for HCV+ participants), and predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 1, Day 7 (HCV+ participants), and Day 10 (healthy participants)|All Treated Participants with available PK data. Participants in the Placebo group did not receive MK-3281 and therefore did not have PK data reported.||ratio||90% Confidence Interval|Geometric Mean
760681|NCT00635804|Secondary|Apparent Half-Life (t ½) of MK-3281|Blood samples were obtained from participants and MK-3281 apparent t ½ was calculated at Day 7 (for HCV+ participants) or Day 10 (for healthy participants) using the MK-3281 assay. Harmonic mean t ½ and pseudo standard deviation were reported.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours post-dose on Day 7 (HCV+ participants) or Day 10 (healthy participants)|All Treated Participants with available PK data. Participants in the Placebo group did not receive MK-3281 and therefore did not have PK data reported.||hour||Standard Deviation|Mean
760682|NCT00635804|Secondary|Time To Reach Cmax (Tmax) of MK-3281|Blood samples were obtained from participants and MK-3281 Tmax was calculated at Days 1 and 7 (for HCV+ participants) or Day 10 (for healthy participants) using the MK-3281 assay.|Predose daily on Days 2-9 (for healthy participants) and Days 2-6 (for HCV+ participants), and predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 1, Day 7 (HCV+ participants), and Day 10 (healthy participants)|All Treated Participants with available PK data. Participants in the Placebo group did not receive MK-3281 and therefore did not have PK data reported.||hour||Full Range|Median
760683|NCT00635804|Secondary|12-Hour Concentration of MK-3281 in Plasma (C12hr)|Blood samples were obtained from participants and MK-3281 plasma C12hr was calculated at Days 1 and 7 (for HCV+ participants) or Day 10 (for healthy participants) using the MK-3281 assay.|Predose daily on Days 2-9 (for healthy participants) and Days 2-6 (for HCV+ participants), and predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 1, Day 7 (HCV+ participants), and Day 10 (healthy participants)|All Treated Participants with available PK data. Participants in the Placebo group did not receive MK-3281 and therefore did not have PK data reported.||μM||Geometric Coefficient of Variation|Geometric Mean
760684|NCT00635804|Secondary|Maximum Plasma Concentration (Cmax) of MK-3281|Blood samples were obtained from participants and MK-3281 Cmax was calculated at Days 1 and 7 (for HCV+ participants) or Day 10 (for healthy participants) using the MK-3281 assay.|Predose daily on Days 2-9 (for healthy participants) and Days 2-6 (for HCV+ participants), and predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 1, Day 7 (HCV+ participants), and Day 10 (healthy participants)|All Treated Participants with available PK data. Participants in the Placebo group did not receive MK-3281 and therefore did not have PK data reported.||μM||Geometric Coefficient of Variation|Geometric Mean
760685|NCT00635804|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to Time 12 Hours (AUC[0-12]) of MK-3281|Blood samples were obtained from participants and MK-3281 AUC(0-12) was calculated at Days 1 and 7 (for HCV+ participants) or Day 10 (for healthy participants) using the MK-3281 assay.|Predose daily on Days 2-9 (for healthy participants) and Days 2-6 (for HCV+ participants), and predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 1, Day 7 (HCV+ participants), and Day 10 (healthy participants)|All Treated Participants with available PK data. Participants in the Placebo group did not receive MK-3281 and therefore did not have PK data reported.||μM·hr||Geometric Coefficient of Variation|Geometric Mean
760686|NCT00635804|Primary|Number of Participants Who Discontinued Study Medication Due to AEs|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR’s product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR’s product, was also an AE.|Up to 14 days after the last dose of study drug (up to 24 days maximum)|All Treated Participants||participants|||Number
760687|NCT00635804|Primary|Number of Participants Experiencing Adverse Events (AEs)|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR’s product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR’s product, was also an AE.|Up to 14 days after the last dose of study drug (up to 24 days maximum)|All Treated Participants||participants|||Number
760688|NCT00635817|Post-Hoc|Percentage of Participants With a Decrease From Baseline in the Ratio of Bone Age to Chronological Age at Month 6 Compared to Baseline|The ratio at baseline or Month 6 was calculated as bone age at baseline or Month 6/chronological age at baseline or Month 6. The percentage of participants with a decrease in the ratio was calculated as a simple percentage for each dose group. Observed data were used with no imputation for missing data. The baseline time frame was increased from the secondary outcome in this analysis to include all participants with a bone age radiograph at screening. This analysis was performed after the clinical study report was completed & is included to match the FDA package insert.|Baseline to Month 6|The baseline time frame was increased from the secondary outcome to this analysis to include all participants with a bone age radiograph at screening. This analysis was performed post hoc to match the FDA package insert.||Percentage of Participants|||Number
767732|NCT00697593|Primary|Biochemistry - Aspartate Transaminase (AST)|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 2 participants missing values||IU/L||Standard Deviation|Mean
760689|NCT00635817|Post-Hoc|Percentage of Participants With Suppression of Peak Stimulated Luteinizing Hormone (< 4 mIU/mL) From Month 2 Through Month 6 (Simple Percentage With Binomial Exact Confidence Intervals)|Percentage of participants with suppression of peak stimulated luteinizing hormone that was measured after a GnRHa stimulation test at Mo 2, 3, and 6. A simple percentage and binomial exact confidence intervals were used in this analysis. Participants who withdrew with luteinizing hormone that remained suppressed were counted as a success. This analysis was performed after the clinical study report was completed and is included to match the FDA package insert.|Month 2 through 6|Subjects must have received at least 1 dose of study drug and had at least 1 postbaseline measurement of peak stimulated luteinizing hormone at Mo 2 or afterward defined as the intent-to-treat population.||Percentage of Participants||95% Confidence Interval|Number
760690|NCT00635817|Secondary|Ratio of Change From Baseline in Bone Age/Change From Baseline in Chronological Age at Month 6|The ratio at Month 6 was calculated as (bone age at Month 6 - bone age at baseline)/(chronological age at Month 6 - chronological age at baseline). Observed data were used with no imputation for missing data. Baseline bone-age radiograph was performed at or within 3 months of the Screening Visit.|Baseline to Month 6|Participants must have received at least 1 dose of study drug and had at least 1 postbaseline measurement defined as the intent-to-treat population.||Ratio||Standard Deviation|Mean
760691|NCT00635817|Secondary|Change From Baseline in Incremental Growth Rate (cm/Year) at Month 6|The growth rate at baseline was the growth rate during the last year before the start of treatment and was calculated with the measurement closest to Day -336 (before Day -30) and the measurement up to Day 1. Growth rate at Month 6 was defined as the ratio of the change in height from Day 1 to the change in chronological age, with an approximate 6-month interval between the 2 height measurements. Observed data were used with no imputation for missing data.|Baseline and Month 6|Subjects must have received at least 1 dose of study drug and had at least 1 postbaseline measurement defined as the intent-to-treat population.||cm/year||Standard Deviation|Mean
760692|NCT00635817|Secondary|Percentage of Participants With Suppression of the Physical Signs of Puberty (Testicular Volume and Genital Development) at Month 6|Percentage of participants with suppression of genital development and testicular volume, out of the number of boys with pubertal staging of genital development or testicular volume (n/N%). Only boys are analyzed in this outcome measure. External genital development (testes and penis) was rated from Stage 1 (early development) through Stage 5 (full development) according to a Tanner Staging pictogram. Boys entering the study with fully developed genitals (Stage 5) were excluded from this analysis. Observed data were used with no imputation for missing data.|Month 6|Subjects must have received at least 1 dose of study drug and had at least 1 postbaseline measurement defined as the intent-to-treat population.||Percentage of Participants||95% Confidence Interval|Number
760693|NCT00635817|Secondary|Percentage of Participants With Suppression of the Physical Signs of Puberty (Breast Development) at Month 6|Percentage of participants with suppression of breast development, out of the number of girls with pubertal staging of breast development (n/N%). Only girls are analyzed in this outcome measure. Breast development was rated from Stage 1 (early development) through Stage 5 (full development) according to a Tanner Staging pictogram. Girls entering the study with fully developed breasts (Stage 5) were excluded from this analysis. Observed data were used with no imputation for missing data.|Month 6|Subjects must have received at least 1 dose of study drug and had at least 1 postbaseline measurement defined as the intent-to-treat population.||Percentage of Participants||95% Confidence Interval|Number
760694|NCT00635817|Secondary|Peak-stimulated Luteinizing Hormone Concentration by Visit|Observed data were used with no imputation for missing data.|Baseline, Month 1, 2, 3 and 6|Subjects must have received at least 1 dose of study drug and had at least 1 postbaseline measurement defined as the intent-to-treat population.||mIU/mL||Standard Deviation|Mean
760695|NCT00635817|Secondary|Percentage of Participants With Suppression of Testosterone in <30 ng/dL by Visit|Percentage of participants with suppression of testosterone, out of the number of boys with at least 1 testosterone measurement at each visit (n/N%). Only boys are analyzed in this outcome measure. Observed data were used with no imputation for missing data.|Month 1, 2, 3 and 6|Subjects must have received at least 1 dose of study drug and had at least 1 postbaseline measurement defined as the intent-to-treat population.||Percentage of Participants||95% Confidence Interval|Number
760696|NCT00635817|Secondary|Percentage of Participants With Suppression of Basal Estradiol <20 pg/mL by Visit|Percentage of participants with suppression of estradiol, out of the number of girls with at least 1 estradiol measurement at each visit (n/N%). Only girls are analyzed in this outcome measure. Observed data were used with no imputation for missing data.|Month 1, 2, 3 and 6|Subjects must have received at least 1 dose of study drug and had at least 1 postbaseline measurement defined as the intent-to-treat population.||Percentage of Participants||95% Confidence Interval|Number
760697|NCT00635817|Primary|Percentage of Participants With Suppression of Peak Stimulated Luteinizing Hormone (<4 mIU/mL) From Month 2 Through Month 6|Percentage of participants with suppression of peak stimulated luteinizing hormone that was measured after a gonadotropin-releasing hormone agonist (GnRHa) stimulation test at Month (Mo) 2, 3, and 6. The analysis was performed according to a life table method. Subjects who withdrew without peak-stimulated luteinizing hormone >= 4 mIU/mL were censored at their last measurement of peak-stimulated luteinizing hormone.|Month 2 through 6|Subjects must have received at least 1 dose of study drug and had at least 1 postbaseline measurement of peak stimulated luteinizing hormone at Mo 2 or afterward defined as the intent-to-treat population.||Percentage of Participants||95% Confidence Interval|Number
760698|NCT00635830|Primary|Measure Serious Adverse Experiences, Systemic Adverse Experiences Occurring Within 14 Days After Vaccination, and Injection-site Complaints Occurring Day 1 Through Day 5 After Vaccination|All adverse experiences were collected from the time the consent form was signed through 14 days following the vaccination. All subjects were requested to record injection-site adverse experiences and monitor temperature daily on the Vaccination Report Card for Day 1 thereafter for 4 additional calendar days, and record all systemic adverse experiences that occur during the 14-day period after injection|For serious adverse experiences and systemic adverse experiences: 14 days follow-up after one dose of vaccination; For injection-site adverse experiences: 5 days follow-up after one dose of vaccination|||Participants|||Number
760699|NCT00635882|Other Pre-specified|Baseline Exhaled Nitric Oxide (eNO) Parts Per Billion (Ppb)||Baseline|||ppb||Standard Deviation|Mean
760700|NCT00635882|Secondary|Change From Baseline in PM PEF at Days 1-15||Baseline and Days 1-15|All randomized participants||liters/minute||Standard Deviation|Mean
760702|NCT00635882|Secondary|Change From Baseline in PM Total Asthma Symptom Score at Days 1-15|Twice daily, participants rated the following asthma symptoms as experienced during the time period since the last evaluation: wheezing, difficulty breathing, and cough on a scale of 0 (none) to 3 (severe, very uncomfortable and interfered with most or all of normal daily activities/sleep). The total asthma symptom score ranged from 0 to 9. The results were recorded in the participant's diary.|Baseline and Days 1-15|All randomized participants||units on a scale||Standard Deviation|Mean
760703|NCT00635882|Secondary|Change From Baseline in AM Total Asthma Symptom Score at Days 2-15|Twice daily, participants rated the following asthma symptoms as experienced during the time period since the last evaluation: wheezing, difficulty breathing, and cough on a scale of 0 (none) to 3 (severe, very uncomfortable and interfered with most or all of normal daily activities/sleep). The total asthma symptom score ranged from 0 to 9. The results were recorded in the participant's diary.|Baseline and Days 2-15|All randomized participants||units on a scale||Standard Deviation|Mean
760704|NCT00635882|Secondary|Mean Change From Baseline to Day 15 of Mannitol Challenge|Mannitol challenge (also referred to as PD15) is the provocative dose of mannitol required to produce a 15% reduction in the forced expiratory volume (in liters) in one second (FEV1).|Baseline to Day 15|All randomized participants||milligrams||Standard Deviation|Mean
760705|NCT00635882|Secondary|Mean Percent Change From Baseline to Day 14 in Sputum Eosinophil Count (Percentage)||Baseline to Day 14|All randomized participants||percentage of Sputum Eosinophil Count||Standard Deviation|Mean
760706|NCT00635882|Secondary|Mean Percent Change From Baseline to Day 7 in eNO Ppb||Baseline to Day 7|All Randomized Participants||percentage of eNO||Standard Deviation|Mean
760707|NCT00635882|Primary|Mean Percent Change From Baseline to Day 14 in Exhaled Nitric Oxide (eNO) Parts Per Billion (Ppb)||Baseline to Day 14|All Randomized Participants||percentage of eNO||Standard Deviation|Mean
760708|NCT00636077|Primary|Effect of Increased Dialysate Flow Rate on Whole Blood B2-microglobulin Clearance Between 4 Dialyzers With Different Membrane Packing Densities.||During the third treatment with each dialyzer (one time during each trial period week)|||whole blood clearance B2-microglobulin||Standard Error|Mean
760709|NCT00636077|Primary|Effect of Increased Dialysate Flow Rate on KoA for b2-microglobulin Between 4 Dialyzers With Different Membrane Packing Densities.||During the third treatment with each dialyzer (one time during each trial period week)|||KoA for b2-microglobulin (mL/min)||Standard Error|Mean
760710|NCT00636077|Primary|Effect of Increased Dialysate Flow Rate on Whole Blood Phosphorus Clearance Between 4 Dialyzers With Different Membrane Packing Densities.||During the third treatment with each dialyzer (one time during each trial period week)|||whole blood phosphorus clearance mL/min||Standard Error|Mean
760711|NCT00636077|Primary|Effect of Increased Dialysate Flow Rate on KoA for Phosphorus Between 4 Dialyzers With Different Membrane Packing Densities.||During the third treatment with each dialyzer (one time during each trial period week)|||KoA for Phosphorus (mL/min)||Standard Error|Mean
760712|NCT00636077|Primary|Effect of Increased Dialysate Flow Rate on Whole Blood Urea Clearance Between 4 Dialyzers With Different Membrane Packing Densities.||During the third treatment with each dialyzer (one time during each trial period week)|||Whole blood urea clearance (mL/min)||Standard Error|Mean
760713|NCT00636077|Primary|Effect of Increased Dialysate Flow Rate on KoA for Urea Between 4 Dialyzers With Different Membrane Packing Densities.|KoA is a constant that describes the efficiency of a dialyzer in removing urea. KoA is determined by surface area of the membrane, the thickness of the membrane and pore size.|During the third treatment with each dialyzer (one time during each trial period week)|||KoA for urea (mL/min)||Standard Error|Mean
760714|NCT00636155|Secondary|Overall Survival||5 years|All patients who received treatment||months||95% Confidence Interval|Median
760715|NCT00636155|Secondary|Progression Free Survival|Progression is defined as at least one of the following: 1) ≥ 50% increase in the sum of the products of at least two lymph nodes one two consecutive determinations (at least one node must be ≥ 2 cm); appearance of new palpable lymph nodes, 2) ≥ 50% increase in the size of the liver and/or spleen; appearance of palpable hepatomegaly or splenomegaly, which was not previously present, 3) ≥ 50% increase in the absolute number of circulating lymphocytes to at least 5,000/µl or 4)Transformation to a more aggressive histology.|5 years|All patients who received treatment||months||95% Confidence Interval|Median
760716|NCT00636155|Primary|Number of Patients With an Overall Response (Complete Response + Partial Response)|Overall Response is the total number of participants with a Complete (CR) or Partial (PR) response. CR requires the absence of lymphadenopathy, hepatomegaly or splenomegaly and constitutional symptoms and a normal CBC; bone marrow must be at least normocellular for age, with less than 30% nucleated cells being lymphocytes with no lymphoid nodules. Partial Response: requires ≥ 50% decrease in one of the following: peripheral blood lymphocyte count, lymphadenopathy, enlargement of liver and/or spleen, or bone marrow involvement by CLL AND at least one hematologic parameter met for 2 months.|every 3 cycles|Patients completing at least 2 cycles of treatment||participants|||Number
760717|NCT00636168|Secondary|Mean Change From Baseline in Global Health Status Scores at Each Assessment Timepoint|Global health status was measured using European Organization for Research and Treatment of Cancer (EORTC) Quality Life Questionnaire (QLQ) C-30. This health related quality of life (HRQoL) questionnaire was comprised of 15 questions on functional scales, 13 questions on symptom scales and 2 on global health status scale. Global Health Status used a 7 point Likert-type scale of 1 (Very poor) to 7 (Excellent). All scales linearly transformed to 0-100 scales. Higher scores for Global Health Status indicate better HRQoL. An increase from baseline indicates improvement in HRQoL compared to baseline. HRQoL was administered within 1 week prior to first dose (baseline) and on Days 22, 43, 64 (+/- 3 days), Week 24 and every 12 weeks up to 2 years, independent of disease progression.|Baseline up to 2 years from randomization|All randomized patients (ITT) analyzed in the arm to which they were allocated by randomization were analyzed. At timepoint level, all randomized patients (ITT) with a measurement at the timepoint were considered.||units on a scale||Standard Deviation|Mean
760726|NCT00636194|Secondary|Symptoms and Complaints|Scores on a scale from 0 to 100, with 100 being the most favorable. Eyes with multiple unscheduled visits in a visit category were counted once for their lowest score.|2 weeks|All eligible, dispensed eyes||Score on a scale|Participants|Standard Deviation|Mean
760727|NCT00636194|Primary|Subjective Assessment of Comfort and Cleanliness|Scale from 0-100 for each eye where 100=most favorable rating and 0=the least favorable rating.|7 days|All eyes||Scores on a scale|Participants|Standard Deviation|Mean
760718|NCT00636168|Secondary|Exposure Adjusted Incidence Rate of Adverse Events Including Multiple Occurrences of Unique Events|P-Y = person-years of exposure. Incidence rate per 100 person-years of exposure (IR/100 P-Y) was calculated as event count * 100 /person-years of exposure. MedDRA Version: 16.1. Duplicate AEs have been eliminated and overlapping and contiguous occurrences of the same event have been collapsed.|Day 1 up to 70 days after last dose or last known alive date for participants still being dosed; up to 5 years|All patients who received at least one dose of ipilimumab or placebo, adjusted for person-years (P-Y) of exposure; P-Y=440.5; P-Y=728.1 for ipilimumab and placebo, respectively.||events/100 person-years of exposure|||Number
760719|NCT00636168|Secondary|Number of Patients With Adverse Events (AEs) Leading to Discontinuation of Treatment, Serious AEs (SAEs), Drug-Related SAEs, Immune-related AEs (irAEs), Immune-mediated Adverse Reactions (imARs), Deaths in Treated Population|AEs: Medical Dictionary for Regulatory Activities (MedDRA) version 16.1. irAEs=unknown etiology consistent with an immune phenomenon, considered as causally related to drug. imARs=based on investigator’s assessment of immune-mediated etiology [excluding novel maintenance events (ie, patients with imARs occurring for the first time during maintenance)]. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related (D-R)=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling, Gr 5=Death.|Day 1 up to 70 days after last dose or last known alive date for patients still being dosed; up to 5 years|All patients who received at least one dose of treatment were analyzed. Patients were analyzed in their randomized group provided they received the randomized treatment at least once; those who received incorrect medication for the entire treatment period were analyzed in the group associated with the incorrect medication.||participants|||Number
760720|NCT00636168|Secondary|Rate of Overall Survival (OS)|OS was defined as the time from the date of randomization to the date of death. For those participants who have not died, OS was censored at the recorded last non-missing date of contact for which the participant was known to be alive.|From date of randomization to date of death, assessed up to 5 years|Intent to Treat Population||Percentage of participants||95% Confidence Interval|Number
760721|NCT00636168|Secondary|Number of Patients With Distant Metastasis or Death as Per Independent Review Committee (IRC) in the Intent to Treat (ITT) Population|Distant Metastasis-Free Survival (DMFS) was programmatically determined based on the first date of distant metastasis provided by the IRC and was defined as the time between the date of randomization and the date of first distant metastasis or death (whatever the cause), whichever occurred first. A patient who died without reported disease distant metastasis was considered to have distant metastasis on the date of death. For those who remained alive and metastasis-free, DMFS was censored on the date of last evaluable post-randomization tumor assessment. For those who remained alive and had no recorded post-randomization tumor assessment, DMFS was censored on the day of randomization. Patients with disease at baseline were considered to have an event on the day of randomization. Disease was assessed at baseline (randomization) and every 12 weeks (±2 weeks) for 3 years, then every 24 weeks until documented distant progression.|From June 2008 to January 2016 (approximately 90 months)|Intent to Treat Population||Participants|||Count of Participants
760722|NCT00636168|Primary|Recurrence-Free Survival (RFS) Rates Per IRC at 1 Year, 2 Years, and 3 Years in the ITT Population|RFS was defined as the time between the date of randomization and the date of first recurrence or death (whatever the cause), whichever occurred first. A patient who died without reported recurrence was considered to have recurrence on the date of death. For those who remained alive and recurrence-free, RFS was censored on the date of last evaluable post-randomization tumor assessment. For those who remained alive and had no recorded post-randomization tumor assessment, RFS was censored on the day of randomization. Patients with disease at baseline were considered to have an event on the day of randomization. CT and MRI were mandatory to establish recurrence. Yearly recurrence-free survival rates, eg. at 1 year, defined as the probability that a participant was recurrence-free at 1 year following randomization, were estimated for each treatment group using the Kaplan-Meier product-limit method, along with their corresponding log-log transformed 95% confidence intervals.|Randomization up to Years 1, 2, and 3|All randomized patients (ITT), analyzed in the arm to which they were allocated by randomization were analyzed.||Percent Probability||95% Confidence Interval|Number
760723|NCT00636168|Primary|Number of Patients With Recurrence or Death as Per Independent Review Committee (IRC) in the Intent to Treat (ITT) Population|Recurrence was defined as appearance of one or more new melanoma lesions: local, regional or distant metastasis. Computerized tomography (CT) and magnetic resonance imaging (MRI) were mandatory to establish recurrence. A patient who died without reported recurrence was considered to have recurred on the date of death. Disease was assessed at randomization and every 12 weeks (±2 weeks) for 3 years, then every 24 weeks until documented distant progression.|Date of randomization to first date of recurrence or death or last available disease assessment with RFS data upto 5 years. Median follow-up was 2.7 years.|All randomized patients (ITT), analyzed in the arm to which they were allocated by randomization were analyzed.||participants|||Number
760724|NCT00636168|Primary|Recurrence Free Survival (RFS) Per Independent Review Committee (IRC) in the Intent to Treat (ITT) Population|Recurrence free survival (RFS) was programmatically determined based on the disease recurrence data provided by the IRC and was defined as the time between the date of randomization and the date of first recurrence or death (whatever the cause), whichever occurred first. A patient who died without reported recurrence was considered to have recurrence on the date of death. For those patients who remained alive and recurrence-free, RFS was censored on the date of last evaluable post-randomization tumor assessment. For those who remained alive and had no recorded post-randomization tumor assessment, RFS was censored on the day of randomization. Patients with disease at baseline were considered to have an event on the day of randomization. Computerized tomography (CT) and magnetic resonance imaging (MRI) were mandatory to establish recurrence. The primary analysis was event-driven and planned when at least 512 RFS events assessed per IRC were collected.|Date of randomization to first date of recurrence or death or last available disease assessment with RFS data up to 5 years. Median follow-up was 2.7 years.|All randomized patients (ITT), analyzed in the arm to which they were allocated by randomization were analyzed.||months||95% Confidence Interval|Median
760728|NCT00636207|Primary|Cmax Accumulation Ratio of Montelukast - Multiple Doses|The Cmax Accumulation Ratio of Montelukast was calculated as the geometric mean ratio of Cmax on the last day and the first day of a multiple dose regimen: Day 5/Day 1 in Part II and Day 10/Day 1 in Part III.|up to 10 days after first dose of study drug|Per Protocol Population: All participants who complied with the protocol||ratio|||Number
760729|NCT00636207|Primary|AUC 0-24hr Accumulation Ratio of Montelukast - Multiple Doses|The AUC 0-24hr Accumulation Ratio of Montelukast was calculated as the geometric mean ratio of AUC 0-24hr on the last day and the first day of a multiple dose regimen: Day 5/Day 1 in Part II and Day 10/Day 1 in Part III.|up to 10 days after first dose of study drug|Per Protocol Population: All participants who complied with the protocol||ratio|||Number
760730|NCT00636207|Primary|t1/2 of Montelukast - Multiple Doses|Blood samples for assessment of t1/2 were drawn predose and then at specified timepoints (up to 24 hours postdose) on Days 1 and 5 in Part II and on Days 1 and 10 in Part III.|Up to 24 hours postdose|Per Protocol Population: All participants who complied with the protocol||hours||Standard Deviation|Mean
760731|NCT00636207|Primary|Apparent Terminal Half Life (t1/2) of Montelukast - Single Dose|Blood samples for assessment of t1/2 were drawn predose and then at specified timepoints (up to 24 hours postdose) on Day 1 in Part I.|Up to 24 hours postdose|Per Protocol Population: All participants who complied with the protocol||hours||Standard Deviation|Mean
760732|NCT00636207|Primary|Tmax of Montelukast - Multiple Doses|Blood samples for assessment of Tmax were drawn predose and then at specified timepoints (up to 24 hours postdose) on Days 1 and 5 in Part II and on Days 1 and 10 in Part III.|Up to 24 hours postdose|Per Protocol Population: All participants who complied with the protocol||hours||Full Range|Median
760733|NCT00636207|Primary|Time to Cmax (Tmax) of Montelukast - Single Dose|Blood samples for assessment of Tmax were drawn predose and then at specified timepoints (up to 24 hours postdose) on Day 1 in Part I.|Up to 24 hours postdose|Per Protocol Population: All participants who complied with the protocol||hours||Full Range|Median
760734|NCT00636207|Primary|Cmax of Montelukast - Multiple Doses|Blood samples for assessment of Cmax were drawn predose and then at specified timepoints (up to 24 hours postdose) on Days 1 and 5 in Part II and on Days 1 and 10 in Part III.|Up to 24 hours postdose|Per Protocol Population: All participants who complied with the protocol||ng/mL||Standard Deviation|Mean
760735|NCT00636207|Primary|Maximum Plasma Concentration (Cmax) of Montelukast - Single Dose|Blood samples for assessment of Cmax were drawn predose and then at specified timepoints (up to 24 hours postdose) on Day 1 in Part I.|Up to 24 hours postdose|Per Protocol Population: All participants who complied with the protocol||ng/mL||Standard Deviation|Mean
760736|NCT00636207|Primary|AUC 0-24hr of Montelukast - Multiple Doses|Blood samples for assessment of AUC 0-24hr were drawn predose and then at specified timepoints (up to 24 hours postdose) on Days 1 and 5 in Part II and on Days 1 and 10 in Part III.|Up to 24 hours postdose|Per Protocol Population: All participants who complied with the protocol||ng/mL*hr||Standard Deviation|Mean
760737|NCT00636207|Primary|Area Under the Curve From 0 to 24 Hours (AUC 0-24hr) of Montelukast - Single Dose|Blood samples for assessment of AUC 0-24hr were drawn predose and then at specified timepoints (up to 24 hours postdose) on Day 1 in Part I.|Up to 24 hours postdose|Per Protocol Population: All participants who complied with the protocol||ng/mL*hr||Standard Deviation|Mean
760738|NCT00636207|Primary|Number of Participants Who Discontinued Study Drug Due to an Adverse Event||Up to 7 days after last dose of study drug|Safety Population: All participants who received at least one dose of study drug||participants|||Number
760739|NCT00636207|Primary|Number of Participants Who Experienced At Least One Adverse Event||Up to 14 days after last dose of study drug|Safety Population: All participants who received at least one dose of study drug||participants|||Number
760740|NCT00636220|Secondary|The Effectiveness of MPC and Chembio Oral Fluid Collection Devices||1-3||||||
760741|NCT00636220|Primary|Number of Fresh Oral Fluid Samples With Known HIV (+) Status and HIV Reactivity|Known HIV status determined clinically or serologically. HIV reactivity for all 100 samples determined first by licensed EIA and then confirmed with Western Blot and/or NAT testing.|1 to 3 days|||samples|||Number
760742|NCT00636363|Primary|Contact Lens Deposits|Lens deposits assessed at each follow-up visit. Degree of deposits assessed as none, light, medium, or heavy.|At each visit for 3 months|Lens deposits, All eligible, dispensed eyes.||Eyes|Participants||Number
760743|NCT00636363|Primary|Subjective Responses to Comfort Related Symptoms/Complaints|Subject symptoms/complaints will be assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints.|Over 4 visits for the 3 month period|Comfort related symptoms/complaints for all eligible, dispensed eyes. Over all follow-up visits.||Scores on a Scale|Participants|Standard Deviation|Mean
760744|NCT00636363|Primary|Slit-lamp Findings > Grade 2|eyes with any slit lamp findings greater than Grade 2 at any visit. Slit lamp findings for each eye will be graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). Epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, superior tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates will be assessed.|Over 4 visits for 3 month period|Over all follow-up visits, all dispensed eyes||participants|Participants||Number
760745|NCT00636389|Primary|A Comparison of Pre- to Post-dialysis Reduction of Small and Large Molecules Under Conditions of Routine Hemodialysis.|Overall removal of urea, phosphorus and β2-microglobulin was determined from the pre- to post-dialysis change in plasma concentration and from the amount of solute recovered in the dialysate. This outcome measure is reported as the percentage of pre- to post-dialysis reduction of urea, phosphorus and β2-microglobulin.|2 weeks = duration required for each subject to complete 6 consecutive dialysis treatments|||Percentage of reduction||Standard Deviation|Mean
760746|NCT00636389|Secondary|Comparison of Dialyzer Ease of Use Between the Polyflux HD-C4 Dialyzer and the Polyflux 210H|Assessment of blood side priming: 1=Very Easy 2=Acceptable 3=Difficult 4=Very Difficult / Assessment of dialysate side priming: 1=Perfect 2=Acceptable 3= Not Acceptable / Appearance of dialyzer fibers: 1=Very Good 2=Good 3=Poor 4=Very Poor / Appearance of dialyzer arterial header: 1=Very Good 2=Good 3=Poor 4=Very Poor / Appearance of venous header: 1=Very Good 2=Good 3=Poor 4=Very Poor /|2 weeks = duration required for each subject to complete 6 consecutive dialysis treatments|Each of the 12 subjects underwent three consecutive treatments with the HD-C4 and three consecutive treatments with the Polyflux 210H.||Units on a Scale 1 = Best|dialyzers|Standard Deviation|Mean
788002|NCT00855439|Secondary|Cardiac Autonomic Neuropathy (CAN)|Group differences in E/I ratio, a measure of cardiac autonomic function.|18 months|||unit-less measure||Standard Deviation|Mean
760747|NCT00636389|Primary|Comparison of Urea Removal Under Conditions of Routine Hemodialysis.|Urea removal is correlated with successful clinical outcomes. Kt/V is a way of measuring the delivered dose of dialysis where K=clearance of urea, t=treatment time and V=volume of body water. Single-pool (sp) Kt/V assumes that urea is removed from a single compartment in the human body during dialysis. However, because there are multiple compartments in the human body, rebound occurs following hemodialysis which lowers the Kt/V. Equilibrated (e) Kt/V is an equation that has been devised to predict the amount of rebound based on the ratio of K/V. Outcomes are posted for both spKt/V and eKt/V.|2 weeks = duration required for each subject to complete 6 consecutive dialysis treatments|||ratio||Standard Deviation|Mean
760748|NCT00636441|Secondary|Patients' Perceptions of Participating in a Clinical Trial Evaluating Cancer Genomics for PST of Early-stage Breast Cancer.|A short questionnaire was administered at baseline (the day chemotherapy was started) and following post-surgical medical oncology evaluation to assess the patient’s understanding of the study being conducted, and the patient’s expectations of the treatment. Due to space limitations, the full survey is presented in the Detailed Description.|1 year|The overall enrollment was insufficient to provide for any substantive analysis.|||||
760749|NCT00636441|Secondary|Economic Impact of Using Genomic Assessment to Guide Management.|Economic Impact (i.e., cost of care) will be calculated by first assessing the quantity of clinical resources used by each patient in the study arm, and then assigning a cost to each resource using cost information derived from a costing study to be undertaken outside of this protocol.|5 years|Since these data were not collected, this analysis could not be done.|||||
760750|NCT00636441|Secondary|Overall Survival|Overall survival is defined as the time from enrollment to death due to any cause. The 2-year overall survival rate is estimated with the Kaplan-Meier method.|2 years|All eligible treated patients with known follow-up status.||Estimated % of participants surviving||95% Confidence Interval|Number
760751|NCT00636441|Secondary|Sites of Recurrence|Sites of Recurrence is a categorical outcome whose possible values are the organ-specific sites at which disease recurrence was observed. A patient may recur at more than one site.|10 years|All eligible treated patients. Four of these 38 participants experienced recurrence of their breast cancer; two of the four patients had multiple sites of recurrence.||participants|||Number
760752|NCT00636441|Secondary|Disease-free Survival|Disease-free survival is defined as the length of time from enrollment to local or distant disease recurrence, whichever comes first; disease-free deaths are censored. The 2-year disease-free survival rate is estimated with its 95% confidence interval.|2 years|All eligible treated patients were used in this analysis.||estimated % of participants disease-free||95% Confidence Interval|Number
760753|NCT00636441|Secondary|Clinical Response Using WHO Criteria|"WHO criteria are based on the sum of the products of the longest axis and the longest perpendicular axis. Bi-dimensional measurements were taken of all breast lesions and axillary nodes using the best imaging modality performed after completion of assigned therapy.
Clinical Complete Response (cCR): Disappearance of all target lesions by physical exam and best imaging modality.
Clinical Partial Response (cPR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.
Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the sum LD at treatment initiation. Patients having a documented response with no reconfirmation of the response will be listed with stable disease.
Progression (PD): At least a 20% increase in the sum of the LD of target lesions or the appearance of one or more new lesion."|12 weeks, 2-3 weeks after the fourth cycle of chemotherapy|All eligible treated patients were used in this analysis.||participants|||Number
760754|NCT00636441|Secondary|To Percentage of Patients Who Had Breast-conserving Surgery at First Attempt.|The percentage of patients who had breast-conserving surgery at first attempt, measured only in patients with T2 tumors classified as potential candidates for breast conservation.|6 months|Data from all eligible patients with non-missing values on this outcome were used.||percentage of T2 tumor patients||95% Confidence Interval|Number
760755|NCT00636441|Secondary|Percentage of Patients Who Had Breast-conserving Surgery With Negative Margins|The percentage of patients who had breast-conserving surgery with negative margins, measured in patients with T2 and T3 tumors classified as requiring mastectomy at baseline.|6 months|Since final margin status was not collected, this analysis could not be done.|||||
760756|NCT00636441|Secondary|Probabilities of Being Sensitive to AC and TC as Determined by the Patient’s Genomic Signatures|To determine in early stage breast cancer treated with PST whether genomic profiling can identify drug-sensitive and drug-resistant patients including a comparison of subgroups for the two individual regimens (i.e. AC and TC). To determine if the 60% cutoff for the genomic profiles is optimal in predicting the response to chemotherapy regimens.To describe the performance of the genomic profiles in assessing the relative responsiveness of: 1) Patients predicted to be resistant to both chemotherapy regimens; and 2) Patients randomly assigned to one treatment whose genomic profiles suggest receiving the other regimen (in both AC and TC subgroups).|10 years|This outcome is not summarized due to irreproducibility of the genomics-based prediction model and resulting probability estimates|||||
760757|NCT00636441|Primary|Pathologic Complete Response (pCR) Rate in Patients With HER2-negative Early-stage Breast Cancer|Pathological complete response (pCR) was defined as the disappearance of all invasive disease in the breast or if only residual in situ or lymph node disease is found. The pCR rate is presented with its 95% confidence interval for the Guided and Non-guided arms.|4-5 weeks after the fourth cycle of chemotherapy; approximately 16-17 weeks|All eligible treated patients. The three patients not included are two who had allergic reactions to the assigned treatment, and one with metastatic disease on biopsy of a spine lesion at the end of assigned treatment so never went to surgery.||percentage of participants||95% Confidence Interval|Number
760758|NCT00636610|Secondary|Progression-free Survival (PFS) in Patients With Various Degrees of Hedgehog Antigen Tumor Expression|Indian + Sonic Hedgehog antigen expression was measured by quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) from archival tumor tissue taken from each patient prior to enrollment in the study. Results are reported in 3 categories; the 33% of patients with the lowest level of expression, the 35% of patients with a middle level of expression, and the 32% of patients with the highest level of expression. PFS was defined as the time between randomization and disease progression, as confirmed by radiography, or death for any reason.|From first treatment through the data cut-off date of March 15, 2010, up to 90 weeks|Intent-to-treat patient population: All randomized patients. Tissue for evaluation was only available for 64 patients in the vismodegib group and 75 patients in the placebo group.||Months||90% Confidence Interval|Median
760759|NCT00636610|Primary|Progression-free Survival (PFS)|Progression-free survival (PFS) was defined as the time from randomization to the earlier of documented disease progression (PD) or death from any cause. PD: At least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started, unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions. For patients without measurable disease, PD was defined as an increase in the size of a lesion to one that is measurable or unequivocal progression of a non-target lesion.|From first treatment through the data cut-off date of March 15, 2010, up to 90 weeks|Intent-to-treat patient population: All randomized patients.||Months||90% Confidence Interval|Median
760760|NCT00636636|Other Pre-specified|Mean Change in Last Observation Carried Forward (LOCF) Average Daily Pain Score|Average daily pain scored on 11-point numerical rating scale (where 0 = no pain, 10 = worst possible pain). Results presented as least squares (LS) mean change in last observation carried forward (LOCF) average daily pain score from baseline to final week of efficacy treatment period (Week 10).|10 weeks|||Scores on a scale||Standard Error|Least Squares Mean
760761|NCT00636636|Secondary|Average Daily Sleep Interference Score|Assessed on 11-point numeric rating scale (where 0 = pain does not interfere with sleep, 10 = pain completely interferes with sleep); evaluated from daily sleep entry in electronic diary. Results presented as least squares (LS) mean change in baseline observation carried forward (BOCF) average daily sleep interference score from baseline to final week of treatment period (Week 10).|10 weeks|||Scores on a scale||Standard Error|Least Squares Mean
760762|NCT00636636|Secondary|Clinical Global Impression of Change (CGIC)|"Investigator assessment of patient's overall PHN symptoms at end of treatment period (Week 10) compared to overall PHN symptoms at baseline; scored on 7-point numerical rating scale (where 1 = very much improved, 7 = very much worse). Results presented as number of participants categorized at end of treatment (Week 10) as very much improved (score = 1) or much improved (score = 2)."|10 weeks|||Participants|||Number
760763|NCT00636636|Secondary|Patient Global Impression of Change (PGIC)|"Patient self-assessment of how much pain had changed at end of treatment period (Week 10) compared to pain at baseline; scored on 7-point numerical rating scale (where 1 = very much improved, 7 = very much worse). Results presented as number of participants categorized at end of treatment (Week 10) as very much improved (score = 1) or much improved (score = 2)."|10 weeks|ITT, BOCF||Participants|||Number
760764|NCT00636636|Primary|Mean Change in Baseline Observation Carried Forward (BOCF) Average Daily Pain Score|Average daily pain scored on 11-point numerical rating scale (where 0 = no pain, 10 = worst possible pain). Results presented as least squares (LS) mean change in baseline observation carried forward (BOCF) average daily pain score from baseline to the final week of efficacy treatment period (Week 10).|10 weeks|ITT, BOCF||Scores on a scale||95% Confidence Interval|Least Squares Mean
760765|NCT00636649|Secondary|Number of Participants Who Had a 50% Reduction in NEQ Scores|The Night Eating Questionnaire (NEQ) is a 14 item self-report scale designed to assess the symptoms of NES including nocturnal ingestions, evening hypcrphagia, morning anorexia, and mood/slccp. Scores range from 0 to 56, with higher scores indicative of greater severity.|Week 12|||participants|||Number
760766|NCT00636649|Secondary|Number of Participants Who no Longer Meet the NESHI Criteria|The Night Eating Syndrome History and Inventory (NESHI) is an unpublished, semistructured interview used to confirm a diagnosis of NES. It assesses a typical 24-hour food intake, including a recall of all meals and snacks, and sleeping patterns. Based on the recall of all meals and snacks, the interviewer judged whether ≥25% of the daily caloric intake was eaten after the evening meal and how often nocturnal ingestions occurred. The NEQ items were reviewed and informed by the dietary recall during the interview, and a new total score was tallied. A final score of ≥25 for the NEQ items, as reviewed during the NESHI, was used as the criterion for NES.|Week 12|||participants|||Number
760767|NCT00636649|Secondary|Change in Weight||Baseline, 12 week|||kg||Standard Error|Mean
760768|NCT00636649|Secondary|Change in Glucose||Baseline, 12 Week|||mg/dL||Standard Error|Mean
760769|NCT00636649|Secondary|Change in Beck Anxiety Inventory (BAI) Score|The Beck Anxiety Inventory (BAI) is a 21-item self-report measure of anxiety. Scores range from 0 to 63, with higher scores indicative of higher levels of anxiety.|Baseline, 12 weeks|||units on a scale||Standard Error|Mean
760770|NCT00636649|Secondary|Change in Lipid Panel||Baseline,12 weeks|||mg/dL||Standard Error|Mean
760771|NCT00636649|Secondary|Number of Participants With a Clinical Global Impression - Improvement (CGI-I) Score ≤ 2|The CGI-I scale is a clinician rating of overall therapeutic effect ranging from 1 (very much improved) to 7 (very much worse) since commencing treatment.|12 weeks|||participants|||Number
760772|NCT00636649|Secondary|Change in Three Factor Eating Questionnaire (TFEQ)|"The TFEQ (also known as the Eating Inventory) measures dimensions of eating behavior including cognitive restraint of eating, disinhibition, and hunger using a combination of dichotomous questions, 4-point likert scales, and one 5-point likert scale. Restraint is comprised of the responses to 21 questions with possible scores ranging from 0 to 21 (Low scores for all scales indicate an uninhibited eating behavior.). Disinhibition is comprised of the responses to 16 questions with possible scores ranging from 0 to 16 (High scores indicate an uninhibited eating behavior strongly depending on external cues). Hunger is comprised of the responses to 14 questions with possible scores ranging from 0 to 14 ( Low scores indicate an eating behavior strongly depending on feelings of hunger.).
RES = Restraint Subscale; DIS = Disinhibition Subscale; HUN = Hunger Subscale"|Baseline, 12 weeks|||units on a scale||Standard Error|Mean
760773|NCT00636649|Secondary|Change in Perceived Stress Scale (PSS)|The Perceived Stress Scale (PSS) measures the overall level of stress. This instrument contains 14 items accessing overall appraisals of stress in the past month. Minimum score (best value)=0. Maximum score (worst value)=56. A higher score indicates greater stress.|12 weeks|Participants who completed PSS assessment at baseline and week 12.||units on a scale||Standard Error|Mean
760784|NCT00636805|Secondary|Acute Chemotherapy-Induced Nausea and Vomiting (CINV) Complete Response (CR) Rate by Anticoagulant Use at Baseline|Acute Chemotherapy-Induced Nausea and Vomiting (CINV) complete response (CR) rate is defined as the percentage of patients who do not have an emetic episode or use antiemetic rescue medication during the first 24 hours following chemotherapy of the first cycle of treatment.|Day 1 of the first week of chemotherapy|Intent-to-treat; 11 patients did not complete the study measure for day 1 of the first week of chemotherapy||percentage of participants||95% Confidence Interval|Number
760774|NCT00636649|Secondary|Change in Coping Inventory for Stressful Situations (CISS)|TASK = task-oriented coping; EMOT = emotion-oriented coping; AVD = avoidance-focused coping; Avoidance-focused coping may be divided into two subtypes: DIS = distraction-oriented coping; SOC = social diversion-oriented coping. CISS is a 48 item self-report measure used to measure responses to stressful situations rated for frequency on a 5 point Likert scales ranging from1, not at all to 5, very much. This measure assesses three coping styles: Task-Oriented, Emotion-Oriented, and two types of Avoidance-Oriented coping (Social Diversion and Distraction). There are 16 items on each of the primary scales (task, emotion, avoidance) and 5 on social diversion and 8 on distraction. Scores are summed for each subscale and then converted to gender-corrected t-scores with a mean of 50 and a standard deviation of 10. T-scores on the CISS range from a low of 25 (1st percentile) to 75 (99th percentile). Higher scores indicate more adaptive levels of coping.|Baseline, 12 weeks|||t-scores||Standard Error|Mean
760775|NCT00636649|Secondary|Change in Beck Depression Inventory II (BDI-II) Score|The BDI-II is a 21-item self-report questionnaire designed to measure cognitive, somatic, and behavioral aspects of depression. Scores range from 0 to 63, with higher scores indicating a higher level of depressive symptoms.|Baseline, 12 weeks|||units on a scale||Standard Error|Mean
760776|NCT00636649|Primary|Night Eating Questionnaire|The Night Eating Questionnaire (NEQ) is a 14-item self-report scale designed to assess the symptoms of NES including nocturnal ingestions, evening hyperphagia, morning anorexia, and mood/sleep. Scores range from 0-56, with higher scores indicative of greater severity. The NEQ has an acceptable internal consistency reliability (.70). A cut-score of 25 has been shown to yield a positive predictive value of .62.|baseline, 12 weeks|Data were analyzed as intent-to-treat with all 40 patients included in the analysis. Primary endpoint was change in the NEQ total score, i.e., difference between values between Week 12 (study exit) and baseline. Analysis of covariance was the primary statistical procedure with baseline NEQ score and baseline BMI as covariates.||units on a scale||Standard Error|Mean
760777|NCT00636701|Primary|Percentage BOLD (Blood-oxygen-level Dependent Contrast Imaging) Signal From Baseline at 2 Weeks|Blood-oxygen-level dependent contrast imaging, or BOLD-contrast imaging, is a method used in functional magnetic resonance imaging (fMRI) to observe different areas of the brain or other organs, which are found to be active at any given time. In 1990, three papers published by Seiji Ogawa and colleagues showed that haemoglobin has different magnetic properties in its oxygenated and deoxygenated forms, both of which could be detected using MRI. This leads to magnetic signal variation which can be detected using an MRI scanner. Given many repetitions of a thought, action or experience, statistical methods can be used to determine the areas of the brain which reliably have more of this difference as a result, and therefore which areas of the brain are active during that thought, action or experience. The percentage BOLD was measures at day 0 and day two weeks. We measured the change in the dependent measure from day 0 to day 2 weeks .|Baseline (day 0) and 2 weeks|Four right‐handed healthy volunteers (two men, aged 20–50 years) participated in a double‐blind study of primed and unprimed rTMS.||percentage change of BOLD||Standard Deviation|Mean
760778|NCT00636792|Secondary|Number of Participants With Overall Response (Complete and Partial Response)|Response is assessed by investigator according to International Working Group (IWG) criteria. Complete response requires disappearance of all evidence of disease. Partial response requires regression of measurable disease and no new sites.|12 weeks after the last subject completes their end of treatment visit|||participants|||Number
760779|NCT00636792|Primary|Number of Participants With Complete Response|Response is assessed by investigator according to International Working Group (IWG) criteria. Complete response requires disappearance of all evidence of disease.|12 weeks after the last subject completes their end of treatment visit.|Response-evaluable population is defined at patients treated with 90 mg/m^2 bendamustine, received at least one dose of any study drug, and had at least one post baseline response assessment.||participants|||Number
760780|NCT00636805|Secondary|Overall Mean Change in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score From Baseline to Day 5 of the First Week of Chemotherapy by Acute Chemotherapy-Induced Nausea and Vomiting (CINV) Complete Response (CR)|Overall mean change in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score from baseline to day 5 of the first week of chemotherapy. The FACIT-Fatigue is a 13-item validated questionnaire assessing the impact of fatigue on an individual's quality of life. The raw score range is 0-52 with higher scores indicating better quality of life. The mean change from baseline to day 5 was calculated by subtracting the baseline score from the mean of the day 1-5 scores, thus a negative mean change represents worsening in quality of life due to fatigue. Acute CINV complete response (CR) is defined as not having an emetic episode or any use of antiemetic rescue medication during the first 24 hours following chemotherapy of the first cycle of treatment.|Baseline through day 5 of the first week of chemotherapy|Intent-to-treat; 16 patients did not complete the study measure at baseline or on day 5 of the first week of chemotherapy||units on a scale||95% Confidence Interval|Mean
760781|NCT00636805|Secondary|Overall Mean Change in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score From Baseline to Day 5 of the First Week of Chemotherapy|Overall mean change in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score from baseline to day 5 of the first week of chemotherapy. The FACIT-Fatigue is a 13-item validated questionnaire assessing the impact of fatigue on an individual's quality of life. The raw score range is 0-52 with higher scores indicating better quality of life. The mean change from baseline to day 5 was calculated by subtracting the baseline score from mean of the day 1-5 scores, thus a negative mean change represents worsening in quality of life due to fatigue.|Baseline through day 5 of the first week of chemotherapy|Intent-to-treat; 16 patients did not complete the study measure at baseline or on day 5 of the first week of chemotherapy||units on a scale||95% Confidence Interval|Mean
760782|NCT00636805|Secondary|Percentage of Patients With ≥ Grade 3, Treatment-related Toxicities|Percentage of patients with ≥ grade 3, treatment-related toxicities using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|6 weeks|||participants|||Number
760783|NCT00636805|Secondary|Delayed Chemotherapy-Induced Nausea and Vomiting (CINV) Complete Response (CR) Rate|Delayed Chemotherapy-Induced Nausea and Vomiting (CINV) complete response (CR) rate is defined as the percentage of patients who do not have an emetic episode or use antiemetic rescue medication during days 2 through 5 of chemotherapy treatment during the first cycle of treatment|Days 2-5 of the first week of chemotherapy|Intent-to-treat; 10 patients did not complete the study measure for days 2-5 of the first week of chemotherapy||percentage of participants||95% Confidence Interval|Number
760785|NCT00636805|Secondary|Acute Chemotherapy-Induced Nausea and Vomiting (CINV) Complete Response (CR) Rate by Corticosteroid Use at Baseline|Acute Chemotherapy-Induced Nausea and Vomiting (CINV) complete response (CR) rate is defined as the percentage of patients who do not have an emetic episode or use antiemetic rescue medication during the first 24 hours following chemotherapy of the first cycle of treatment.|Day 1 of the first week of chemotherapy|Intent-to-treat; 11 patients did not complete the study measure for day 1 of the first week of chemotherapy||percentage of participants||95% Confidence Interval|Number
760786|NCT00636805|Primary|Acute CINV (Chemotherapy Induced Nausea and Vomiting) CR (Complete Response) Rate|Acute Chemotherapy-Induced Nausea and Vomiting (CINV) complete response (CR) rate is defined as the percentage of patients who do not have an emetic episode or use antiemetic rescue medication during the first 24 hours following chemotherapy of the first cycle of treatment.|first 24 hours of the first week of chemotherapy|Intent-to-treat; 11 patients did not complete the study measure for day 1 of the first week of chemotherapy||percentage of participants||95% Confidence Interval|Number
760787|NCT00636818|Secondary|Cytochrome P450 2D6 (CYP2D6) Phenotype Status|CYP2D6 is the primary atomoxetine metabolizing enzyme. Metabolizzer status was determined by focusing on the normal, decreased, and defective allele. Poor metabolizer = defective/defective. Extensive metabolizer is all except for poor metabolizer.|8 Weeks|Number of participants who received at least one dose of study drug.||participants|||Number
760788|NCT00636818|Secondary|Number of Participants With Abnormal QTc Interval Based on International Conference on Harmonisation Criterion|The Fridericia correction of the QT interval (QTcF) was used.|Baseline to 8 Weeks|Number of participants with baseline and post-baseline values.||participants|||Number
760789|NCT00636818|Secondary|Significant Changes in Body Weight During the Study|Potentially clinically significant weight loss was defined as any decrease of at least 7 percent (%). Potentially clinically significant weight gain was defined as any increase of at least 7%.|Baseline to 8 Weeks|Number of participants with baseline and post-baseline values.||participants|||Number
760790|NCT00636818|Secondary|Number of Participants With Potentially Clinically Significant Changes in Vital Signs During the Study|Vital signs reported are Pulse (beats per minute [bpm]), Systolic Blood Pressure (SBP) (mmHg), and Diastolic Blood Pressure (DBP) (mmHg).|Baseline to 8 Weeks|Number of participants with baseline and post-baseline values.||participants|||Number
760791|NCT00636818|Secondary|Change From Baseline to 8 Week Endpoint in Short Form-36 Version 2 (SF-36v2)|SF-36 assesses quality of life (QoL) on 8 domains and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). MCS and PCS scores=0-100 (higher scores indicate better QoL). Raw domain scores: general health=5-25; physical functioning=10-30; role-physical=4-20; role-emotional=3-15; social functioning=2-10; bodily pain=2-12; vitality=4-20; mental health=5-25. Using norm based scores, all domains, MCS and PCS scores have average score of 50 with standard deviation of 10. Norm-based score=Z-score*10+50 in each subscale. Range cannot be specified in norm-based scores.|Baseline and 8 Weeks|Number of participants who received at least one dose of study drug and had a baseline and at least one post-baseline value. Last observation carried forward.||T-Score||Standard Deviation|Mean
760792|NCT00636818|Secondary|Change From Baseline to 8 Week Endpoint in Stroop Color Word Test|This was a psychological test to observe the interference in which disparity between the meaning and color affects reading speed. A subject was given 3 tasks of recognition: reading the printed colored ink (Color Test), reading color words in black ink (Word Test), and interference, reading color words printed in different colored ink (Word-Color Test). The test was scored on the number of correct answers. There were 100 items for each of the three categories and if they made it through the 100 words with time remaining, they would repeat the list.|Baseline and 8 Weeks|Number of participants who received at least one dose of study drug and had a baseline and at least one post-baseline value. Last observation carried forward.||number of correct answers||Standard Deviation|Mean
760793|NCT00636818|Secondary|Change From Baseline to 8 Week Endpoint in Hamilton Anxiety Rating Scale (HAMA-14)|The HAMA-14 scale measures anxiety symptoms accompanying Major Depressive Disorder (MDD). Each item of the 14-item HAMA was scored from 0 (not present) to 4 (very severe), with a resulting maximum total score of 56.|Baseline and 8 Weeks|Number of participants who received at least one dose of study drug and had a baseline and at least one post-baseline value. Last observation carried forward.||units on a scale||Standard Deviation|Mean
760794|NCT00636818|Secondary|Change From Baseline to 8 Week Endpoint in 17-Item Hamilton Depression Rating Scale (HAMD-17)|The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).|Baseline and 8 Weeks|Number of participants who received at least one dose of study drug and had a baseline and at least one post-baseline value. Last observation carried forward.||units on a scale||Standard Deviation|Mean
760795|NCT00636818|Secondary|Change From Baseline to 8 Week Endpoint in Conners' Adult ADHD Rating Scale-Self Rated:Screening Version (CAARS-S:SV) Total ADHD Symptom Score|Conners' Adult Attention-Deficit Hyperactivity Disorder (ADHD) Rating Scale-Self Rating:Screening Version. Total ADHD symptom score consisted of 18 items (sum of inattention and hyperactivity-impulsivity subscales) using a 4-point scale (0=not at all/never to 3=very much/very frequently) for total score range of 0 to 54.|Baseline and 8 Weeks|Number of participants who received at least one dose of study drug and had a baseline and at least one post-baseline value. Last observation carried forward.||units on a scale||Standard Deviation|Mean
760796|NCT00636818|Secondary|Change From Baseline to 8 Week Endpoint in Clinical Global Impressions-ADHD Severity (CGI-ADHD-S)|Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).|Baseline and 8 Weeks|Number of participants who received at least one dose of study drug and had a baseline and at least one post-baseline value. Last observation carried forward.||units on a scale||Standard Deviation|Mean
760797|NCT00636818|Secondary|Change From Baseline to 8 Week Endpoint in Conners' Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale-Investigator Rated:Screening Version (CAARS-Inv:SV) Total ADHD Symptom Score|Conners' Adult Attention-Deficit Hyperactivity Disorder (ADHD) Rating Scale-Investigator Rating:Screening Version. Total ADHD symptom score consisted of 18 items (sum of inattention and hyperactivity-impulsivity subscales) using a 4-point scale (0=not at all/never to 3=very much/very frequently) for total score range of 0 to 54.|Baseline and 8 Weeks|Number of participants who received at least one dose of study drug and had a baseline and at least one post-baseline value. Last observation carried forward.||units on a scale||Standard Deviation|Mean
760798|NCT00636818|Primary|Discontinuations Due to Adverse Events (AE)|The definition of a study adverse event was any unfavorable medical event, newly emerged or a deterioration of a preexisting condition, in other words any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship, that occurred after the visit for informed consent and up to the visit for completion of administration, or discontinuation.|Baseline to 8 Weeks|Number of participants who received at least one dose of study drug.||participants|||Number
760799|NCT00636961|Secondary|Dyspnoea Measured by Borg CR10 Scale at Day 1, Day 14|The modified Borg CR10 Scale consists of 12-point score that the patients point to so as to indicate their level of dyspnoea (where 0 indicates no breathlessness at all to 12 indicates maximum breathlessness), before and during exercise testing. A reduction in this score indicates an improvement. Isotime was defined as the time the subject was still exercising in the shortest of all sub-maximal exercise tests. Peak time was defined as the last measurement taken in the exercise period. Analysis of variance included period, treatment and sequence as fixed effects and subject as random effect.|Day 1, Day 14|The safety analysis set consisted of all patients who received study medication and had at least one assessment.||Score on a scale||90% Confidence Interval|Least Squares Mean
760800|NCT00636961|Secondary|Chronic Activity Related Breathlessness Measured by Transition Dyspnoea Index (TDI) at Day 14|Dyspnoea was measured during the treatment period using the transition dyspnoea index (TDI), which captures changes from baseline. The TDI has three domains; functional impairment, magnitude of task and magnitude of effort. TDI domains are rated from -3 (major deterioration) to 3 (major improvement) and rates are summed for transition focal score ranging from -9 to 9; minus scores indicate deterioration. A TDI focal score of 1 was considered to be a clinically significant and meaningful improvement from baseline. Analysis of variance included period baseline dyspnoea index (BDI) as covariate.|Day 14|The safety analysis set consisted of all patients who received study medication and had at least one assessment.||Score on a scale||90% Confidence Interval|Least Squares Mean
760801|NCT00636961|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) Measured by Spirometry on Day 14|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose. The linear mixed model included the baseline FEV1 measurement as covariate.|Day 14|The safety analysis set consisted of all patients who received study medication and had at least one assessment.||Liters||90% Confidence Interval|Least Squares Mean
760802|NCT00636961|Secondary|Static Inspiratory Capacity (IC) at Day 14|Inspiratory Capacity (IC) at resting (static IC) was measured by using whole body plethysmography. The day 14 measurement was analyzed using an analysis of variance including baseline (day -2) as a covariate,|Day 14|The safety analysis set consisted of all patients who received study medication and had at least one assessment.||Liters||90% Confidence Interval|Least Squares Mean
760803|NCT00636961|Primary|Inspiratory Capacity (IC) at Peak Time and at Isotime on Day 14|Inspiratory capacity (IC) at peak time and at isotime were the primary pharmacodynamic (PD) variables of interest. IC was measured at two minute intervals during exercise. Isotime was defined as the time the subject was still exercising in the shortest of all sub-maximal exercise tests (3-minutes resting pedaling, 3-minutes unloaded pedaling and exercise with loaded pedaling). Peak time was defined as the last measurement taken in the exercise period. The primary analysis consisted of a linear mixed effects model with baseline IC measurement as covariate.|Day 14|The safety analysis set consisted of all patients who received study medication and had at least one assessment.||Liters||90% Confidence Interval|Least Squares Mean
760804|NCT00636987|Primary|Characterize the Hemodynamic Performance of the Valve|"Gradient is the pressure difference from one side of the valve to the other side of the valve. For this study pressure is measured in mmHg.
Mean gradient for each patient is the average of the pressure differences from one side of the valve to the other side of the valve."|5 Year|Number of participants that completed the visit and assessment||mmHg||Standard Deviation|Mean
760805|NCT00636987|Primary|Characterize Patient NYHA Functional Classification Status|"The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life.
Class I. Patients with cardiac disease but without resulting limitation of physical activity.
Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest.
Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest.
Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest.
The Criteria Committee of the New York Heart Association. Nomenclature and Criteria for Diagnosis of Diseases of the Heart and Great Vessels. 9th ed. Boston, Mass: Little, Brown & Co; 1994:253-256."|5 year|Number of participants that completed the visit and assessment||participants|||Number
760806|NCT00636987|Primary|Number of Participants With Adverse Events|Number of participants with Adverse Events|5 Years|||participants|||Number
760807|NCT00637000|Secondary|Summary of Participants With Treatment-Emergent Adverse Events (TEAEs)|"Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Severity was graded by the investigator as mild (grade 1), moderate (grade 2) and severe (grade 3)."|Day 1-6|The randomized population included all subjects who were randomized to soluble films and received at least one dose of soluble films.||participants|||Number
760808|NCT00637000|Secondary|Visual Analog Scale (VAS) Scores at End of Induction Period and the Post-induction Period (Maximum Increase) for the Question: “Does the Drug Make You Sick?”|A visual analog scale (VAS) was used by participants to answer the subjective question, “Does the drug make you sick?”. The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=no effect and 100=maximum effect.|End of Induction: 47.5 hours after first administration Peak Post Induction: Days 3-5|Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.||units on a scale||Standard Deviation|Mean
788709|NCT00859339|Primary|Pathological Complete Response (pCR) Rate.|number of participants with a pCR|18 months|8 participants were evaluable for pCR||particpants with pCR|||Number
760809|NCT00637000|Secondary|Visual Analog Scale (VAS) Scores at End of Induction Period and the Post-induction Period (Maximum Increase) for the Question: “Do You Like the Drug?”|A visual analog scale (VAS) was used by participants to answer the subjective question, “Do you like the drug?”. The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=no liking and 100=maximum liking.|End of Induction: 47.5 hours after first administration Peak Post Induction: Days 3-5|Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.||units on a scale||Standard Deviation|Mean
760810|NCT00637000|Secondary|Visual Analog Scale (VAS) Scores at End of Induction Period and the Post-induction Period (Maximum Increase) for the Question: “Does the Drug Have Any Bad Effects?”|A visual analog scale (VAS) was used by participants to answer the subjective question, “Does the drug have any bad effects?”. The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=no bad effects and 100=maximum bad effects.|End of Induction: 47.5 hours after first administration Peak Post Induction: Days 3-5|Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.||units on a scale||Standard Deviation|Mean
760811|NCT00637000|Secondary|Visual Analog Scale (VAS) Scores at End of Induction Period and the Post-induction Period (Maximum Increase) for the Question: “Do You Feel Any Good Effects?”|A visual analog scale (VAS) was used by participants to answer the subjective question, “Do you feel any good effects?”. The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=no good effects and 100=maximum good effects.|End of Induction: 47.5 hours after first administration Peak Post Induction: Days 3-5|Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.||units on a scale||Standard Deviation|Mean
760812|NCT00637000|Secondary|Visual Analog Scale (VAS) Scores at End of Induction Period and the Post-induction Period (Maximum Increase) for the Question: “Do You Feel Any Drug Effect?”|A visual analog scale (VAS) was used by participants to answer the subjective question, “Do you feel any drug effect?”. The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=no effect and 100=maximum effect.|End of Induction: 47.5 hours after first administration Peak Post Induction: Days 3-5|Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.||units on a scale||Standard Deviation|Mean
760813|NCT00637000|Secondary|"Visual Analog Scale (VAS) Scores at End of Induction Period and the Post-induction Period (Maximum Increase) for the Question: How High Are You?"|"A visual analog scale (VAS) was used by participants to answer the subjective question, How high are you?. The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=not high and 100=extremely high."|End of Induction: 47.5 hours after first administration Peak Post Induction: Days 3-5|Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.||units on a scale||Standard Deviation|Mean
760814|NCT00637000|Secondary|Visual Analog Scale (VAS) Score at Baseline and the Peak (Maximum Increase) VAS up to 23.5 Hours After First Administration for the Question: “Does the Drug Make You Sick?”|A visual analog scale (VAS) was used by participants to answer the subjective question, “Does the drug make you sick?”. The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=no effect and 100=maximum effect.|Baseline: 30 minutes prior to first administration on Day 1. Peak: up to 23.5 hours post administration on Day 1|Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.||units on a scale||Standard Deviation|Mean
760815|NCT00637000|Secondary|CVisual Analog Scale (VAS) Score at Baseline and the Peak (Maximum Increase) VAS up to 23.5 Hours After First Administration for the Question: “Do You Like the Drug?”|A visual analog scale (VAS) was used by participants to answer the subjective question, “Do you like the drug?”. The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=no liking and 100=maximum liking.|Baseline: 30 minutes prior to first administration on Day 1. Peak: up to 23.5 hours post administration on Day 1|Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.||units on a scale||Standard Deviation|Mean
767733|NCT00697593|Primary|Biochemistry - Total Bilirubin|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 1 participant missing values||μmol/L||Standard Deviation|Mean
760816|NCT00637000|Secondary|Visual Analog Scale (VAS) Score at Baseline and the Peak (Maximum Increase) VAS up to 23.5 Hours After First Administration for the Question: “Does the Drug Have Any Bad Effects?”|A visual analog scale (VAS) was used by participants to answer the subjective question, “Does the drug have any bad effects?”. The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=no bad effects and 100=maximum bad effects.|Baseline: 30 minutes prior to first administration on Day 1. Peak: up to 23.5 hours post administration on Day 1|Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.||units on a scale||Standard Deviation|Mean
760817|NCT00637000|Secondary|Visual Analog Scale (VAS) Score at Baseline and the Peak (Maximum Increase) VAS up to 23.5 Hours After First Administration for the Question: “Does the Drug Have Any Good Effects?”|A visual analog scale (VAS) was used by participants to answer the subjective question, “Do you feel any good effects?”. The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=no good effects and 100=maximum good effects.|Baseline: 30 minutes prior to first administration on Day 1. Peak: up to 23.5 hours post administration on Day 1|Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.||units on a scale||Standard Deviation|Mean
760818|NCT00637000|Secondary|Visual Analog Scale (VAS) Score at Baseline and the Peak (Maximum Increase) VAS up to 23.5 Hours After First Administration for the Question: “Do You Feel Any Drug Effect?”|A visual analog scale (VAS) was used by participants to answer the subjective question, “Do you feel any drug effect?”. The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=no effect and 100=maximum effect.|Baseline: 30 minutes prior to first administration on Day 1. Peak: up to 23.5 hours post administration on Day 1|Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.||units on a scale||Standard Deviation|Mean
760819|NCT00637000|Secondary|"Visual Analog Scale (VAS) Score at Baseline and the Peak (Maximum Increase) VAS up to 23.5 Hours After First Administration for the Question: How High Are You?"|"A visual analog scale (VAS) was used by participants to answer the subjective question, How high are you?. The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=not high and 100=extremely high.
The baseline VAS was the score obtained 30 minutes prior to administration of soluble films on Day 1. Peak VAS was the highest VAS score obtained between 1-23.5 hours post administration on Day 1."|Baseline: 30 minutes prior to first administration on Day 1. Peak: up to 23.5 hours post administration on Day 1|Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.||units on a scale||Standard Deviation|Mean
760820|NCT00637000|Secondary|Pupil Diameter Measurements At End of Induction (End of Day 2) and the Minimum Pupil Diameter During the Post Induction Period (Days 3-5)|Pupil diameter was measured at the end of induction (47.5 hours after the first administration of study intervention) and at intervals during the post-induction period (Days 3-5). Peak post induction measurement is the minimum pupil diameter recorded during days 3-5.|End of Induction: 47.5 hours after first administration Peak Post Induction: Days 3-5|Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.||mm||Standard Deviation|Mean
760821|NCT00637000|Secondary|Pupil Diameter Measurements at Baseline and the Minimum Pupil Diameter up to 23.5 Hours After the First Administration|Pupil diameter was measured at baseline and at intervals post drug administration on Day 1. Peak measurement is the minimum pupil diameter recorded from 15 minutes to 23.5 hours post administration of study intervention.|Baseline: 15 minutes prior to first administration on Day 1. Peak: 15 minutes - 23.5 hours post administration on Day 1|Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.||mm||Standard Deviation|Mean
760822|NCT00637000|Secondary|Pupil Diameter Measurements at Baseline and the Maximum Pupil Diameter up to 23.5 Hours After the First Administration|Pupil diameter was measured at baseline and at intervals post drug administration on Day 1. Peak measurement is the maximum pupil diameter recorded from 15 minutes to 23.5 hours post administration of study intervention.|Baseline: 15 minutes prior to first administration on Day 1. Peak: 15 minutes - 23.5 hours post administration on Day 1|Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.||mm||Standard Deviation|Mean
760835|NCT00637156|Secondary|Rate of Disc Height Success|Disc height was assessed by determining the Functional Spinal Unit (FSU) height. The rate of disc height success is reported as the percentage of participants whose disc height for each level based on either the anterior or posterior measurements met the following criterion: Postoperative Height - 6 Week Postoperative Height >= -2mm|24 months|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable disc height success (FSU success) status at 24 months, which leads to 170 subjects in the investigational group and 138 subjects in the control group.||percentage of participants|||Number
760823|NCT00637000|Secondary|Severity of Withdrawal Symptoms Measured Using the Clinical Opiate Withdrawal Scale (COWS) at the End of Induction and the Peak COWS Post Induction|"The COWS is an 11-item instrument used to assess symptoms of opioid withdrawal (Wesson et al., 1999). The score is the sum of the response to each of the 11 items and cover a range of 0-48. The COWS is commonly used by clinicians treating patients with buprenorphine to monitor the severity of withdrawal. COWS scores below 5 are considered not indicative of withdrawal. Scores from 5 to 12 are considered mild withdrawal; from 13 to 24 moderate withdrawal; 25 to 36 moderate/severe withdrawal, and 37-48 severe withdrawal.
The end of induction COWS was the score obtained 47.5 hours after first administration of soluble films on Day 1. Peak post induction COWS was the highest COWS score obtained on Days 2-5."|End of Induction: 47.5 hours after first administration Peak Post Induction: Days 3-5|Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.||units on a scale||Standard Deviation|Mean
760824|NCT00637000|Primary|Severity of Withdrawal Symptoms Measured Using the Clinical Opiate Withdrawal Scale (COWS) at Baseline and the Peak COWS up to 23.5 Hours After the First Administration|"The COWS is an 11-item instrument used to assess symptoms of opioid withdrawal (Wesson et al., 1999). The score is the sum of the response to each of the 11 items and cover a range of 0-48. The COWS is commonly used by clinicians treating patients with buprenorphine to monitor the severity of withdrawal. COWS scores below 5 are considered not indicative of withdrawal. Scores from 5 to 12 are considered mild withdrawal; from 13 to 24 moderate withdrawal; 25 to 36 moderate/severe withdrawal, and 37-48 severe withdrawal.
The baseline COWS was the score obtained 30 minutes prior to administration of soluble films on Day 1. Peak COWS was the highest COWS score obtained between 1-23.5 hours post administration on Day 1."|Baseline: 30 minutes prior to first administration on Day 1. Peak: up to 23.5 hours post administration on Day 1|Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.||units on a scale||Standard Deviation|Mean
760825|NCT00637156|Secondary|Change of General Health Status -- SF-36 MCS From Baseline|The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for MCS was between 0 and 100, with higher scores denoting better quality of life. Change of SF-36 MCS score was defined as MCS score at 24 months minus MCS score at baseline.|Baseline and 24 months post-operation|||units on a scale||Standard Deviation|Mean
760826|NCT00637156|Secondary|Change of General Health Status -- SF-36 PCS From Baseline|The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS was between 0 and 100, with higher scores denoting better quality of life. Change of SF-36 PCS score was defined as PCS score at 24 months minus PCS score at baseline.|Baseline and 24 months post-operation|||units on a scale||Standard Deviation|Mean
760827|NCT00637156|Secondary|Change of Arm Pain Score From Baseline|"Numerical rating scales were also used to evaluate arm pain intensity and frequency. Subjects rated their arm pain intensity on a scale from 0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be. Similarly, subjects recorded their arm pain frequency on a scale from 0-10, with a score of 0 being pain none of the time and a score of 10 being pain all of the time. The total arm pain score (0 to 20) was the addition of pain intensity and frequency scores. Change of arm pain score was defined as arm pain score at 24 months minus arm pain score at baseline."|Baseline and 24 months post-operation|||units on a scale||Standard Deviation|Mean
760828|NCT00637156|Secondary|Change of Neck Pain Score From Baseline|"Numerical rating scales were used to evaluate neck pain intensity and frequency. Subjects rated their neck pain intensity on a scale from 0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be. Similarly, subjects recorded their neck pain frequency on a scale from 0-10, with a score of 0 being pain none of the time and a score of 10 being pain all of the time. The total neck pain score (0 to 20) was the addition of pain intensity and frequency scores. Change of neck pain score was defined as neck pain score at 24 months minus neck pain score at baseline."|Baseline and 24 months post-operation|||units on a scale||Standard Deviation|Mean
760829|NCT00637156|Secondary|Change of Neck Disability Index Score From Baseline|The self-administered Neck Disability Index (NDI) Questionnaire was used to assess patient neck pain and ability to function. The NDI scale ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability). Change of NDI was defined as NDI at 24 month minus NDI at baseline.|Baseline and 24 months post-operation|||units on a scale||Standard Deviation|Mean
760830|NCT00637156|Secondary|Rate of Secondary Surgery at Index Level|Secondary surgical procedures at the index level included revisions, removals, supplemental fixations and reoperations. Rate of secondary surgery at index level is reported as percentage of subjects who had secondary surgeries at index level.|24 months|||percentage of participants|||Number
760831|NCT00637156|Secondary|Hospital Stay||From admission to discharge, an average of 1.0-1.5 day|||days||Standard Deviation|Mean
760832|NCT00637156|Secondary|Blood Loss||During the time of operation, an average of 1.7-2.1 hrs|||ml||Standard Deviation|Mean
760833|NCT00637156|Secondary|Operative Time|Operative time was recorded from skin incision to wound closure.|Time of operation, an average of 1.7-2.1hrs|||hrs||Standard Deviation|Mean
760834|NCT00637156|Secondary|Gait Success Rate|Patient's gait was assessed by using Nurick's classification, and indicated either as normal or graded on a scale of 0 to 5. Success was defined as maintenance or improvement in the postoperative status as compared to the preoperative condition: Preoperative Score - Postoperative Score >= 0. The gait success rate is reported as the percentage of participants who had gait success.|24 months|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable gait success status at 24 months, which leads to 199 subjects in the investigational group and 159 subjects in the control group.||percentage of participants|||Number
760912|NCT00637780|Primary|Sulfasalazine Area Under the Concentration-time Profile From Time 0 to Time Tau, the Dosing Interval (AUCtau) at Steady State||Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose|The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses.||mcg*hr/mL|||Number
760836|NCT00637156|Secondary|Success Rate of SF-36 MCS|Success rate of SF-36 Health Survey include two components: the success rate of a physical component summary (PCS) and the success rate of a mental component summary (MCS). The success of SF-36 MCS were defined as: Post Score - Pre Score >= 0. The Success rate of SF-36 MCS is reported as the percentage of the participants who were classified as a success for SF-36 MCS.|24 months|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable SF-36 MCS success status at 24 months, which leads to 197 subjects in the investigational group and 156 subjects in the control group.||percentage of participants|||Number
760837|NCT00637156|Secondary|Success Rate of SF-36 PCS|Success rate of SF-36 Health Survey include two components: the success rate of a physical component summary (PCS) and the success rate of a mental component summary (MCS). The success of SF-36 PCS was defined as: Post Score - Pre Score >= 0. The Success rate of SF-36 PCS is reported as the percentage of the participants who were classified as a success for SF-36 PCS.|24 months|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable SF-36 PCS success status at 24 months, which leads to 197 subjects in the investigational group and 156 subjects in the control group.||percentage of participants|||Number
760838|NCT00637156|Secondary|Arm Pain Success Rate|"Numerical rating scales were used to evaluate pain intensity and frequency. The pain score (0 min, 20 max) was derived by adding the numerical rating scores from the pain intensity (0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be.) and frequency scales (0-10, with a score of 0 being pain none of the time and a score of 10 being pain all of the time). Arm pain success rate is reported as the percentage of participants whose arm pain improvement met the following criterion: Preoperative Score - Postoperative Score > 0."|24 months|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable arm pain success status at 24 months, which leads to 199 subjects in the investigational group and 159 subjects in the control group.||percentage of participants|||Number
760839|NCT00637156|Secondary|Neck Pain Success Rate|"Numerical rating scales were used to evaluate pain intensity and frequency. The pain score (0 min, 20 max) was derived by adding the numerical rating scores from the pain intensity (0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be.) and frequency scales (0-10, with a score of 0 being pain none of the time and a score of 10 being pain all of the time). Neck pain success rate is reported as the percentage of participants whose neck pain improvement met the following criterion: Preoperative Score - Postoperative Score > 0."|24 months|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable neck pain success status at 24 months, which leads to 199 subjects in the investigational group and 159 subjects in the control group.||percentage of participants|||Number
760840|NCT00637156|Secondary|Success Rate of Neurological Status|Success rate of neurological status is reported as the percentage of participants who met neurological success defined as maintenance or improvement in all sections (motor, sensory, and reflexes) for the time period evaluated. In order for a section to be considered a success, each element in the section must either remain the same or improve from the time of the preoperative evaluation to the time period evaluated.|24 months|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable neurological success status at 24 months, which leads to 199 subjects in the investigational group and 159 subjects in the control group.||percentage of participants|||Number
760841|NCT00637156|Secondary|Success Rate of Neck Disability Index|Success rate of Neck Disability Index is reported as the percentage of participants whose neck disability index score met the following criterion: Pre-treatment Score - Post-treatment Score ≥ 15.|24 months|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable NDI success status at 24 months, which leads to 199 subjects in the investigational group and 159 subjects in the control group.||percentage of participants|||Number
760842|NCT00637156|Primary|Rate of Overall Success|"Rate of overall success is reported as the percentage of participants who met all of the following criteria:
Postoperative Neck Disability Index (NDI) score improvement of at least a 15-point increase from preoperative;
Maintenance or improvement in neurological status;
No serious adverse event classified as implant associated or implant/surgical procedure associated; and
No additional surgical procedure classified as a “failure.”"|24 Months|The primary analysis dataset for this study included all subjects who received study devices and completed the initial surgical procedures. The analysis was based on the observed data and missing data due to lost-to-follow-ups were imputed. For the primary endpoint, the analysis consists of 199 investigational subjects and 160 control subjects.||percentage of participants|||Number
760843|NCT00637195|Secondary|Number of Subjects Reporting Medically Significant Conditions|Medically significant conditions include adverse events (AEs) prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|Up to study end (Month 13)|Analysis was performed on the Total Vaccinated cohort, which consisted of all vaccinated subjects for whom data were available.||subjects|||Number
760844|NCT00637195|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Up to study end (Month 13)|Analysis was performed on the Total Vaccinated cohort, which consisted of all vaccinated subjects for whom data were available.||subjects|||Number
760845|NCT00637195|Secondary|Number of Subjects Reporting Unsolicited Adverse Events|Unsolicited adverse event covers any adverse event reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 30-day period following the 4th dose of HBV vaccine|Analysis was performed on the Total Vaccinated cohort, which consisted of all vaccinated subjects for whom data were available.||subjects|||Number
760846|NCT00637195|Secondary|Number of Subjects Reporting Unsolicited Adverse Events|Unsolicited adverse event covers any adverse event reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 30-day period following any vaccination|Analysis was performed on the Total Vaccinated cohort, which consisted of all vaccinated subjects for whom data were available.||subjects|||Number
760847|NCT00637195|Secondary|Number of Subjects Reporting Solicited General Symptoms|"Solicited general symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, rash, temperature [axillary route, ≥ 37.5 degree Celsius (°C)] and urticaria.
Data are presented across doses."|During the 7-day period following the 4th dose of HBV vaccine|Analysis was performed on the Total Vaccinated cohort, which consisted of all vaccinated subjects for whom data were available.||subjects|||Number
760848|NCT00637195|Secondary|Number of Subjects Reporting Solicited General Symptoms|"Solicited general symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, rash, temperature [axillary route, ≥ 37.5 degree Celsius (°C)] and urticaria.
Data are presented across doses."|During the 7-day period following any vaccination|Analysis was performed on the Total Vaccinated cohort, which consisted of all vaccinated subjects for whom data were available.||subjects|||Number
760849|NCT00637195|Secondary|Number of Subjects Reporting Solicited Local Symptoms|"Solicited local symptoms assessed include injection site pain, redness and swelling.
Data are presented across doses."|During the 7-day period following the 4th dose of HBV vaccine|Analysis was performed on the Total Vaccinated cohort, which consisted of all vaccinated subjects for whom data were available.||subjects|||Number
760850|NCT00637195|Secondary|Number of Subjects Reporting Solicited Local Symptoms|"Solicited local symptoms assessed include injection site pain, redness and swelling.
Data are presented across doses."|During the 7-day period following any vaccination|Analysis was performed on the Total Vaccinated cohort, which consisted of all vaccinated subjects for whom data were available.||subjects|||Number
760851|NCT00637195|Secondary|Anti-HBs Antibody Titers Following 2 Doses of Engerix and After Completing the 4-dose Engerix Vaccination Course|Titers are given as Geometric Mean Titers (GMTs) expressed as mIU/mL.|At Months 2 and 13|Analysis was performed on the ATP cohort for analysis of immunogenicity, in subjects with available data and who were negative for anti-hepatitis B core antigen (anti-HBc) before vaccination.||mIU/mL||95% Confidence Interval|Geometric Mean
760852|NCT00637195|Secondary|Number of Subjects Seroprotected Against Anti-Hepatitis B (HBs) Antibodies Following 2 Doses of Engerix and After Completing the 4-dose Engerix Vaccination Course|A subject seroprotected against Hepatitis B is a subject with anti-HBs antibody titers greater than or equal to 10 mIU/mL.|Months 2 and 13|Analysis was performed on the ATP cohort for analysis of immunogenicity, in subjects with available data and who were negative for anti-hepatitis B core antigen (anti-HBc) before vaccination.||subjects|||Number
760853|NCT00637195|Secondary|Number of Subjects Seroconverted for Anti-hepatitis B (HBs) Antibodies|Anti-HBs seroconversion is defined as the appearance [i.e. titer greater than or equal to the cut-off value of 3.3 milli-international units/milliliter (mIU/mL)] of anti-HBs antibodies in the sera of subjects seronegative (with titers below the cut-off value) before vaccination.|Months 2, 3 and 13|Analysis was performed on the ATP cohort for analysis of immunogenicity, in subjects with available data and who were negative for anti-hepatitis B core antigen (anti-HBc) before vaccination.||subjects|||Number
760854|NCT00637195|Secondary|Anti-HPV-16/18 Antibody Titers|Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).|Months 2 and 7|Analysis was performed on the ATP cohort for analysis of immunogenicity, only for subjects receiving Cervarix™ vaccine with available data.||EL.U/mL||95% Confidence Interval|Geometric Mean
760855|NCT00637195|Secondary|Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibodies|"Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination.
Cut-off values assessed include 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies."|Months 2 and 7|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, only for subjects receiving Cervarix™ vaccine and with available data.||subjects|||Number
760856|NCT00637195|Primary|Anti-hepatitis B Surface Antigen (HBs) Antibody Titers Following 3 Doses of Engerix|Titers are given as Geometric Mean Titers (GMTs) expressed as milli-international units per milliliter (mIU/mL).|Month 3|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, in subjects with available data and who were negative for anti-hepatitis B core antigen (anti-HBc) before vaccination.||mIU/mL||95% Confidence Interval|Geometric Mean
760857|NCT00637195|Primary|Number of Subjects Seroprotected Against Hepatitis B Following 3 Doses of Engerix|A subject seroprotected against hepatitis B is a subject with anti-hepatitis B surface antigen (HBs) antibody titers greater than or equal to 10 milli-international units per milliliter (mIU/mL).|Month 3|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, in subjects with available data and who were negative for anti-hepatitis B core antigen (anti-HBc) before vaccination .||subjects|||Number
760858|NCT00637247|Secondary|To Evaluate the OS, ORR, PFS, 1-year Survival, and Changes in CA19.9 of Subjects on the Two Treatment Arms That Completed > 1 Cycle (28 Days) of Protocol Treatment||one year||||||
760859|NCT00637247|Secondary|To Evaluate the Changes in Blood Levels of CA19.9 on the Two Treatment Arms and Whether There is a Relationship to Objective Response, and PFS||one year||||||
760860|NCT00637247|Secondary|One Year Survival|To evaluate the 1-year survival rates of the two treatment arms.|one year||||||
760861|NCT00637247|Secondary|Progression Free Survival|To compare the median progression free survival (PFS) of the two treatment arms. Progression free survival is measured from randomization until the subject has documented disease progression by an objective measure. Subjects were censored if no documented progression had occurred at the one year time point. Subjects must be alive with no more than 20% increase in tumor size to qualify for progression free survival. Changes in tumor size are defined by RECIST criteria.|one year|Intention to treat||months|Participants|95% Confidence Interval|Median
760862|NCT00637247|Secondary|Objective Response Rates of the Two Treatment Arms|Objective response is measured by tumor reduction as defined in the RECIST criteria. Tumor shrinkage must be at least 30% to qualify as an objective response.|one year|Per protocol, response evaluable population was treated and had baseline and at least one response evaluation.||percent of responses|||Number
760863|NCT00637247|Primary|To Evaluate and Compare the Tolerability and Toxicity of the Two Treatment Arms||up to 2 years||||||
760913|NCT00637780|Primary|Sulfasalazine Time for Cmax (Tmax) at Steady State||Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose|The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses.||hours (hr)|||Number
760864|NCT00637247|Primary|Overall Survival for the Intent to Treat Population|To compare the overall survival duration of the two treatment arms. Overall survival is measured from the time of randomization until reported death. Subjects were censored at last time known alive if lost to follow-up. Alive patients were censored at the last survival follow-up. Follow-up was monthly after off study treatment.|up to 2 years|Intention to treat with subjects who were alive at the time of the survival analysis or lost to follow-up were considered censored at the last date the subject was known to be alive.||months||95% Confidence Interval|Median
760865|NCT00637273|Secondary|Assessment on Event Rate of Treatment-emergent Hypoglycemic Events|Major hypoglycemia: events that, in the judgment of the investigator or physician, resulted in loss of consciousness, seizure, coma, or other change in mental status consistent with neuroglycopenia, in which symptoms resolved after administration of intramuscular glucagon or intravenous glucose, required third-party assistance, and was accompanied by a blood glucose concentration < 54 mg/dL prior to treatment. Minor hypoglycemia: symptoms consistent with hypoglycemia and blood glucose concentration < 54 mg/dL prior to treatment and not classified as major hypoglycemia.|Day 1 to Week 26|ITT Population.||rate per subject-year||Standard Error|Mean
760866|NCT00637273|Secondary|Ratio of Fasting Triglycerides at Week 26 to Baseline|Ratio of triglycerides (measured in mg/dL) at Week 26 to baseline (Day 1). Log (Postbaseline Triglycerides) - log (Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline.|Day 1, Week 26|ITT Population. Missing data up to Week 26 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.||ratio||Standard Error|Least Squares Mean
760867|NCT00637273|Secondary|Change in Fasting High-density Lipoprotein (HDL) From Baseline to Week 26|Change in fasting HDL from baseline (Day 1) to Week 26.|Day 1, Week 26|ITT Population. Missing data up to Week 26 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.||mg/dL||Standard Error|Least Squares Mean
760868|NCT00637273|Secondary|Change in Fasting Total Cholesterol From Baseline to Week 26|Change in fasting total cholesterol from baseline (Day 1) to Week 26.|Day 1, Week 26|ITT Population. Missing data up to Week 26 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.||mg/dL||Standard Error|Least Squares Mean
760869|NCT00637273|Secondary|Change in Diastolic Blood Pressure From Baseline to Week 26|Change in diastolic blood pressure from baseline (Day 1) to Week 26.|Day 1, Week 26|ITT Population. Missing data up to Week 26 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.||mmHg||Standard Error|Least Squares Mean
760870|NCT00637273|Secondary|Change in Systolic Blood Pressure From Baseline to Week 26|Change in systolic blood pressure from baseline (Day 1) to Week 26.|Day 1, Week 26|ITT Population. Missing data up to Week 26 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.||mmHg||Standard Error|Least Squares Mean
760871|NCT00637273|Secondary|Change in Fasting Plasma Glucose From Baseline to Week 26|Change in fasting plasma glucose from baseline (Day 1) to Week 26.|Day 1, Week 26|ITT Population. Missing data up to Week 26 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.||mg/dL||Standard Error|Least Squares Mean
760872|NCT00637273|Secondary|Change in Body Weight From Baseline to Week 26|Change in body weight from baseline (Day 1) to Week 26.|Day 1, Week 26|ITT Population. Missing data up to Week 26 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.||kg||Standard Error|Least Squares Mean
760873|NCT00637273|Secondary|Percentage of Subjects Achieving HbA1c Target of <=6.0% at Week 26|Percentages of subjects achieving HbA1c target values of <=6.0% at Week 26.|Week 26|ITT Population. Missing data up to Week 26 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. Subjects without post-baseline HbA1c measurement were categorized as not achieving goal.||percentage of subjects|||Number
760874|NCT00637273|Secondary|Percentage of Subjects Achieving HbA1c Target of <=6.5% at Week 26|Percentages of subjects achieving HbA1c target values of <=6.5% at Week 26.|Week 26|ITT Population. Missing data up to Week 26 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. Subjects without post-baseline HbA1c measurement were categorized as not achieving goal.||percentage of subjects|||Number
760875|NCT00637273|Secondary|Percentage of Subjects Achieving HbA1c Target of <7% at Week 26|Percentages of subjects achieving HbA1c target values of <7% at Week 26.|Week 26|ITT Population. Missing data up to Week 26 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. Subjects without post-baseline HbA1c measurement were categorized as not achieving goal.||percentage of subjects|||Number
760876|NCT00637273|Primary|Change in HbA1c From Baseline to Week 26|Absolute change in HbA1c from baseline (Day 1) to Week 26 [Week 26 - Baseline].|Day 1, Week 26|The ITT Population included randomized subjects who received at least one injection of study medication. Missing data up to Week 26 were imputed using the last observation carried forward (LOCF) approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.||percentage of total hemoglobin||Standard Error|Least Squares Mean
760877|NCT00637299|Secondary|Lung Function Test|residual volume (RV)|4 weeks|||liters||Standard Deviation|Mean
760878|NCT00637299|Primary|Walking Ability|6 minutes walking test (6MWT)|4 weeks|||meters||Standard Deviation|Mean
760879|NCT00637312|Primary|Evaluation of Device and/or Procedure Related Adverse Event(s)||At 24-months|The study was suspended for higher than anticipated adverse events in the treatment group. Enrollment was stopped and patients were followed for 36 months in the Advent treatment group. Agency approval is not being pursued for this device and thus no analysis has been completed.|||||
760880|NCT00637377|Secondary|Mean Change From Baseline in Choroidal Neovascularization (CNV) Area at Week 52 – LOCF|CNV area values measured in square millimeters; lower values represent better outcomes.|Baseline and at week 52|Full-Analysis Set with assessment for this outcome measure; imputation technique: LOCF||mm^2||Standard Deviation|Mean
760881|NCT00637377|Secondary|Mean Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Total Score at Week 52 – LOCF|The possible range of the NEI VFQ-25 total score is between 0 (worst possible) and 100 (best possible).|Baseline and at week 52|Full-Analysis Set with assessment for this outcome measure; imputation technique: LOCF||Scores on a scale||Standard Deviation|Mean
760882|NCT00637377|Secondary|Percentage of Participants Who Gained at Least 15 Letters of Vision in the ETDRS Letter Score in the Study Eye at Week 52 – LOCF|"Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 25 (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning.
Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed."|At week 52|Full-Analysis Set; imputation technique: LOCF||Percentage of participants|||Number
760883|NCT00637377|Secondary|Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by ETDRS Letter Score at Week 52 – LOCF|Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 25 (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning.|Baseline and at week 52|Full-Analysis Set (FAS); imputation technique: LOCF||Letters correctly read||Standard Deviation|Mean
760884|NCT00637377|Primary|Percentage of Participants Who Maintained Vision at Week 52 – Last Observation Carried Forward (LOCF)|"Maintenance of vision was defined as a loss of < 15 letters in the ETDRS (Early Treatment Diabetic Retinopathy Study) letter score (defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 25 (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning.
Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed."|At week 52|Per-Protocol Set (PPS); imputation technique: LOCF||Percentage of participants|||Number
760885|NCT00637416|Primary|Change in Condition Over Treatment Period|Change measured using voice assessment protocol—Grade, Roughness, Breathiness, Asthenia, Strain (GRBAS).|3 months|Study was stopped early, data were not collected, and zero participants were analyzed.|||||
760886|NCT00637494|Secondary|Proportion of Mifepristone Treated Patients With Plasma Drug Concentrations Equal to or Above 1637 ng/mL vs. Placebo Treated Patients Who Achieve a ≤ 50% Reduction in BPRS-PSS at Days 7 and 56|Response as measured by 50% reduction in psychosis at Days 7 and 56 was compared between the group administered placebo and the group who achieved a sufficiently high plasma level of mifepristone|56 days|||participants|||Number
760887|NCT00637494|Primary|Proportion of Mifepristone vs. Placebo Treated Patients With at Least a 50% Reduction From Baseline in Brief Psychiatric Rating Scale-Positive Symptom Subscale (BPRS-PSS) at Days 7 and 56|Response as measured by 50% reduction in psychosis at Days 7 and 56 was compared between the group administered placebo and the group administered mifepristone|56 days|||participants|||Number
760888|NCT00637572|Secondary|Appetite at Baseline (Day 3) and Week 12|"Appetite was assessed via visual analogue scale (VAS) as part of the Bristol-Myers Anorexia/Cachexia Recovery Instrument (BACRI) (Question 5 only). The question was To what extent has your appetite changed since the start of treatment? The response was captured on a VAS scale in cm with a range from 0 ( much worse) to 10 (much better)."|Baseline (Day 3) to Week 12|Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit. Only 29 subjects were analyzed in the micronized formulation treatment group based on available baseline measurements.||cm||Standard Deviation|Mean
760889|NCT00637572|Secondary|Quality of Life (QoL) Via Bristol-Myers Anorexia/Cachexia Recovery Instrument (BACRI) at Baseline (Day 3) and Week 12 (BACRI)|The BACRI instrument is used to measure the benefit of weight gain treatment provided to anorexic patients on health related quality of life aspects. The scale is composed of 9 subscales (0 to 10 [worse to better]). The response was captured on a VAS scale in cm. The total BACRI score is the sum with a minimum score 0=worse and maximum score 90=better. These subscales are: change in weight impacting health; concern about weight; appearance change; change feeling of appearance; change in appetite; enjoy eating; overall feeling; benefit of treatment; and quality of life.|Baseline (Day 3) to Week 12|Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit. Only 29 subjects were analyzed in the micronized formulation treatment group based on available baseline measurements.||cm||Standard Deviation|Mean
760890|NCT00637572|Secondary|Change in Total Energy|Food intake was quantified by the 24-hour recall food diary|Baseline (Day 1) to Week 12|Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit. Only 27 subjects and 22 subjects were analyzed, respectively based on available baseline data.||kcal||Standard Deviation|Mean
760891|NCT00637572|Secondary|Change in Mid-arm Circumference||Baseline (Day 1) to Week 12|Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit||cm||Standard Deviation|Mean
760892|NCT00637572|Secondary|Change in Tricep Skinfold||Baseline (Day 1) to Week 12|Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit||cm||Standard Deviation|Mean
760893|NCT00637572|Secondary|Change in Waist Circumference||Baseline (Day 1) to Week 12|Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit. Only 31 subjects were analyzed for the megestrol acetate oral suspension nanocrystal dispersion group based on available data measurements.||cm||Standard Deviation|Mean
760894|NCT00637572|Secondary|Change in Hip Circumference||Baseline (Day 1) to Week 12|Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit. Only 31 subjects and 29 subjects were analyzed, respectively based on available baseline measurements.||cm||Standard Deviation|Mean
760895|NCT00637572|Secondary|Change From Baseline in Body Fat Mass||Baseline (Day 1) to Week 12|Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit. Only 31 subjects were analyzed for the megestrol acetate oral suspension nanocrystal dispersion group based on available baseline measurements.||kg||Standard Deviation|Mean
760914|NCT00637780|Primary|Sulfasalazine Steady State Maximum Plasma Concentration (Cmax) and Predose Concentration (Cmin)||Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose|The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses.||micrograms (mcg)/milliliter (mL)|||Number
760896|NCT00637572|Secondary|Change From Baseline in Impedance|Electrical impedance is a method for body composition assessment. The procedure involves sending a small current through the body and measuring the resistance in ohm. High resistance is associated with smaller amounts of fat-free mass. Smaller resistance is associated with large amounts of fat-free mass.|Baseline (Day 1) to Week 12|Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit. Only 31 subjects were analyzed for the megestrol acetate oral suspension nanocrystal dispersion group based on available baseline measurements.||ohms||Standard Deviation|Mean
760897|NCT00637572|Secondary|Change From Baseline in Lean Mass||Baseline (Day 1) to Week 12|Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit. Only 31 subjects were analyzed for the megestrol acetate oral suspension nanocrystal dispersion group based on available baseline measurements.||kg||Standard Deviation|Mean
760898|NCT00637572|Primary|Change in Body Weight|Weight gain in adult HIV positive subjects who have weight loss with AIDS related wasting within the first 12 weeks of treatment|Baseline (Day 1) to Week 12|Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit||kg||Standard Deviation|Mean
760899|NCT00637728|Secondary|Change in Appetite Over the 8-week Double-blind Phase as Measured by a VAS Appetite Scale|Subjects marked 6 items on a visual analog scale (VAS) appetite scale including feeling not hungry to hungry, not nauseated to nauseated, empty to full, not satiated to satiated; weak to strong desire to eat; and ability to eat none to a large amount of food|Baseline, Weeks 1, 2, 3, 4, 6 and 8|Results not analyzed due to early termination of the study. Study was terminated early, no data were collected for this Outcome Measure.|||||
760900|NCT00637728|Secondary|Change in Weight Over the Course of the 8-week Double-blind Phase||Baseline, Week 1, 2, 3, 4, 6, and 8|Results not analyzed due to early termination of the study. Study was terminated early, no data were collected for this Outcome Measure.|||||
760901|NCT00637728|Secondary|Changes in Body Composition as Measured by Bioelectric Impedance Analysis (BIA) at Week 4 and Week 8 Relative to Baseline||Baseline, Week 4 and Week 8|Results not analyzed due to early termination of the study. Study was terminated early, no data were collected for this Outcome Measure.|||||
760902|NCT00637728|Primary|Average Daily Caloric Intake Over the Course of the 8-week Double-blind Phase|The Nutrition Data System for Research (NDSR) was used to determine nutrient and caloric value for foods and beverages consumed and recorded by subjects over a 3-day assessment period prior to each visit. Total number of calories consumed during each 3-day assessment was averaged over available values to determine the week’s daily caloric intake value.|8 weeks|Results not analyzed due to early termination of the study. Study was terminated early, no data were collected for this Outcome Measure.|||||
760903|NCT00637780|Secondary|Number of Participants With Vital Signs Values Meeting Categorical Summarization Criteria|Vital sign values which met categorical summarization criteria included: supine/sitting pulse rate less than (<) 40 or more than (>) 120 beats per minute (bpm); erect pulse rate <40 or >140 bpm; changes from baseline in same posture of systolic blood pressure (SBP) more than or equal to (>=) 30 millimeters of mercury (mm Hg) or diastolic blood pressure (DBP) >=20 mm Hg; SBP <90 mm Hg; and DBP <50 mm Hg.|Screening, Day 0, and Day 7|The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses.||participants|||Number
760904|NCT00637780|Secondary|Number of Participants With Laboratory Test Abnormalities|Number of participants with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters included hematology, coagulation, liver function, renal function, electrolytes,clinical chemistry, and urinalysis (dipstick and microscopy).|Screening, Day 0, and Day 7|The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses.||participants|||Number
760905|NCT00637780|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs|An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. TEAEs are defined as newly occurring AEs or those worsening after first dose. AEs comprised both SAEs and non-SAEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Screening through to and including 28 calendar days after the last administration of the investigational product|The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses.||participants|||Number
760906|NCT00637780|Primary|5-aminosalicylic Acid (5-ASA) AUCtau at Steady State|Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug.|Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose|The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses.||mcg*hr/mL|||Number
760907|NCT00637780|Primary|5-aminosalicylic Acid (5-ASA) Tmax at Steady State|Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug.|Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose|The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses.||hr|||Number
760908|NCT00637780|Primary|5-aminosalicylic Acid (5-ASA) Steady State Cmax and Cmin|Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug.|Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose|The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses.||mcg/mL|||Number
760909|NCT00637780|Primary|Sulfapyridine AUCtau at Steady State|Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug.|Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose|The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses.||mcg*hr/mL|||Number
760910|NCT00637780|Primary|Sulfapyridine Tmax at Steady State|Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug.|Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose|The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses.||hr|||Number
760911|NCT00637780|Primary|Sulfapyridine Steady State Cmax and Cmin|Sulfapyridine and 5-aminosalicylic acid (5-ASA) are primary metabolites of sulfasalazine, the study drug.|Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose|The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses.||mcg/mL|||Number
760915|NCT00637806|Secondary|Change in Appetite Over the 8-week Double-blind Phase as Measured by a VAS Appetite Scale|Subjects marked 6 items on a visual analog scale (VAS) appetite scale including feeling not hungry to hungry, not nauseated to nauseated, empty to full, not satiated to satiated; weak to strong desire to eat; and ability to eat none to a large amount of food|Baseline, Weeks 1, 2, 3, 4, 6 and 8|Results not analyzed due to early termination of the study|||||
760916|NCT00637806|Secondary|Changes in Body Composition as Measured by Bioelectric Impedance Analysis (BIA) at Week 4 and Week 8 Relative to Baseline||Baseline, Week 4 and Week 8|Results not analyzed due to early termination of the study|||||
760917|NCT00637806|Secondary|Change in Weight Over the Course of the 8-week Double-blind Phase||Baseline, Week 1, 2, 3, 4, 6, and 8|Results not analyzed due to early termination of the study|||||
760918|NCT00637806|Primary|Average Daily Caloric Intake Over the Course of the 8-week Double-blind Phase|The Nutrition Data System for Research (NDSR) was used to determine nutrient and caloric value for foods and beverages consumed and recorded by subjects over a 3-day assessment period prior to each visit. Total number of calories consumed during each 3-day assessment was averaged over available values to determine the week’s daily caloric intake value.|8 weeks|Results not analyzed due to early termination of the study|||||
760919|NCT00637923|Secondary|Changes in ALT|This analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up.|From baseline to end of follow up|This analysis was conducted using only data for patients that completed the baseline through the end of follow-up time points.||participants|||Number
760920|NCT00637923|Secondary|Changes in ALT|This analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up.|From baseline to end of treatment|This analysis was conducted using only data for patients that completed the baseline through end of treatment time points.||participants|||Number
760921|NCT00637923|Secondary|Changes in ALT|This analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up|From baseline to week 16|This analysis was conducted using only data for patients that completed the baseline through week 16 time points.||participants|||Number
760922|NCT00637923|Secondary|Changes in ALT|This analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up.|From baseline to week 8|This analysis was conducted using only data for patients that completed the baseline through week 8 time points.||participants|||Number
760923|NCT00637923|Secondary|Rapid Virologic Response (HCV RNA Below Lower Limit of Detection)|Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection after 4 weeks of combination therapy.|After 4 weeks combination treatment|||participants|||Number
760924|NCT00637923|Secondary|Early Virologic Response (HCV RNA Below Lower Limit of Detection)|Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection after 12 weeks of combination therapy.|After 12 weeks combination treatment|||participants|||Number
760925|NCT00637923|Secondary|End of Treatment Response (HCV RNA Below Lower Limit of Detection)|Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection at the end of treatment. All others were considered non-responders.|At end of treatment|||participants|||Number
760926|NCT00637923|Primary|Sustained Virologic Response (HCV RNA Below Lower Limit of Detection)|Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection 24 weeks after the end of treatment. All others were considered non-responders.|24 weeks after end of treatment|||participants|||Number
760927|NCT00638014|Secondary|Number of Participants With Sternal Wound Infection or Sternal Instability/Non-union|The Data and Safety Monitoring Board reviewed source documents for all cases with possible sternal wound infection and sternal instability or non-union and made a determination as to the presence of these complications.|Up to 180 days|||Participants|||Number
760928|NCT00638014|Primary|Percentage Change of Preoperative Incentive Spirometry (IS) Volume Achieved|Maximum incentive spirometry volume was measured at baseline (prior to surgery) and daily from postoperative day 1 through postoperative day 7 (or discharge if earlier) using a Coach 2 incentive spirometer with one way valve (Coach 2 model # 22-4000, Smiths Medical, Keene, NH).|Baseline, Maximum value during postoperatively days 1 thru 7|||percentage change||Standard Deviation|Mean
760929|NCT00638027|Secondary|Change in Multiple Sclerosis Functional Composite (MSFC) Score Between Baseline and Week 12|"9-Hole Peg Test (9-HPT) is a quantitative measure of upper extremity function. Timed 25-Foot Walk (T 25 FW) is a quantitative measure of lower extremity function. The patient is instructed to walk 25 feet as quickly as possible, but safely.
Paced Auditory Serial Addition Test-3 seconds (PASAT-3) is a measure of cognitive function that assesses auditory information processing speed and flexibility, as well as calculation ability.
The MSFC is based on the concept that scores for these 3 dimensions—arm, leg, and cognitive function are combined to create a single score that can be used to detect change over time in a group of MS patients. This is done by creating Z-scores for each component of the MSFC. Implicit in this approach is the idea that patients who deteriorate or improve on all 3 component measures will have an overall larger change than patients who change on only 1 of the 3 measures. The MSFC score was transformed to z-scores, with higher scores indicating better outcome."|Baseline, Week 12|Per protocol||Z score||Standard Deviation|Mean
760930|NCT00638027|Secondary|Difference in the Multiple Sclerosis Spacticy Scale (MSSS-88) Between Baseline and 12 Weeks|"Multiple Sclerosis Spacticy Scale (MSSS-88) is a patient reported questionnaire rating scale to quantify the perspectives of the impact of spasticity on people with multiple sclerosis.
Scoring: Individual items are scored on a 4 point Likert scale: 1 (Not bothered at all), 2 (a little bothered), 3 (moderately bothered), 4 (extremely bothered).This questionnaire asks how bothered you have been by your spasticity in the past two weeks. By spasticity we mean muscle stiffness and spasms.The MSSS-88 is a reliable and valid, patient-based, interval-level measure of the impact of spasticity in multiple sclerosis. Scores were summed, without weighting or standardization, to generate ordinal-level total scores just as any other Likert-type scale. Missing responses to items can be replaced with the mean score of the items completed (person-specific item mean score) provided that 50% or more of the items in a scale have been completed. The range is 8-32 and higher scores mean poorer outcome."|baseline, 12 weeks|per protocol||units on a scale||Standard Deviation|Mean
767734|NCT00697593|Primary|Biochemistry - Creatinine|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 1 participant missing values||μmol/L||Standard Deviation|Mean
760931|NCT00638027|Primary|Difference in Ashworth Spasticity Scale Score Between Baseline and 12 Weeks|"spasticity scale score: the most common used tool to measure the degree of spasticity of the lower extremities.
Score: Degree of Muscle Tone 0: no increase in tone
slight increase in tone 1+: slight increase in tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the range of motion.
more marked increase in muscle tone through most of the range of movement, but affected part(s) easily moved.
considerable increase in muscle tone, passive movement difficult.
affected part(s) rigid in flexion or extension."|Baseline and 12 weeks|Per Protocol||units on a scale||Standard Deviation|Mean
760932|NCT00638157|Secondary|Summary of the Investigator's Assessment of Clinical Response at the TOC Visit|TOC/Safety visit occurred 21 to 28 days after the last dose of daptomycin therapy. Clinical response was assessed by the investigator as cure, improvement, failure, and unable to evaluate. Microbiological response, which was determined by the sponsor based on review of baseline and post-baseline culture results, included success, failure, and nonevaluable. TC=Treatment Cure; TF=Treatment Failure; TI=Treatment Improved.|TOC Visit|Modified Intent-to-Treat (mITT) population includes all ITT patients who received at least one dose of study medication.||Participants|||Number
760933|NCT00638157|Primary|Summary of Clinically Significant Increases in Serum Creatinine by Visit|The End of Treatment (EOT)/Early Termination (ET) visit occurred on the day that therapy was stopped or up to 2 days after the last dose of daptomycin. The Test of Cure (TOC)/Safety visit occurred 21 to 28 days after the last dose of daptomycin therapy. The overall median duration of treatment was 13.0 days in both the daptomycin group and the combination therapy group. The definition of elevated serum creatinine at baseline is >3.0 mg/dL, and not elevated is ≤3.0 mg/dL. Clinically significant increases in serum creatinine is defined as an increase ≥0.5 mg/dL for patients with a baseline value ≤3.0 mg/dL or ≥1.0 mg/dL for patients with a baseline value >3.0 mg/dL.|Baseline, EOT Visit, TOC|Safety Population includes all patients who received any dose of study medication.||Participants|||Number
760934|NCT00630292|Primary|Amount of Blood Vessel Tortuosity in Breast With Known Cancer|Amount of vessel tortuosity before the start of neoadjuvant chemotherapy and at the end of neoadjuvant chemotherapy|up to two weeks prior to start of chemotheraphy|Blood vessels could not be detected for any of the subjects due to spatial resolution limits of MRI scanner for breast MRI and therefore measurement of blood vessel angularity could not be performed.||sum of blood vessel angles|||Number
760935|NCT00630305|Primary|Endothelial Bleb Areas on Cornea: Session D- Closed Eye|Mean area of endothelial blebs in the following corneal locations: Central, Nasal, Temporal, Inferior, Superior. A masked observer performed the analysis by subjectively selecting a region in a given image that provided an optimal balance of maximum area and clarity of cell outlines. Blebs were then outlined manually and the software calculated the area of blebs. The different sessions are reported showing results for each lens according to the lens worn in the contralateral (contra) eye.Open eye sessions simulated the subjects normal ocular behavior during waking hours; closed eye sessions simulated ocular activity during duration of closed eye activity, such as sleeping. Results are reported as the mean percent difference between the stated test (senofilcon A) and the control lens (alphafilcon A, lotrafilcon B), after 20 minutes of wear, for each testing scenario.|20 minutes post-lens insertion|The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes.||Percent Difference of Bleb Area|Subject Eyes|Standard Deviation|Mean
760936|NCT00630305|Primary|Endothelial Bleb Areas on Cornea: Session C- Open Eye|Mean area of endothelial blebs in the following corneal locations: Central, Nasal, Temporal, Inferior, Superior. A masked observer performed the analysis by subjectively selecting a region in a given image that provided an optimal balance of maximum area and clarity of cell outlines. Blebs were then outlined manually and the software calculated the area of blebs. The different sessions are reported showing results for each lens according to the lens worn in the contralateral (contra) eye.Open eye sessions simulated the subjects normal ocular behavior during waking hours; closed eye sessions simulated ocular activity during duration of closed eye activity, such as sleeping. Results are reported as the mean percent difference between the stated test (senofilcon A) and the control lens (alphafilcon A, lotrafilcon B), after 20 minutes of wear, for each testing scenario.|20 minutes post-lens insertion|The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes.||Percent Difference of Bleb Area|Subject Eyes|Standard Deviation|Mean
760937|NCT00630305|Primary|Endothelial Bleb Areas on Cornea: Session B- Closed Eye|Mean area of endothelial blebs in the following corneal locations: Central, Nasal, Temporal, Inferior, Superior. A masked observer performed the analysis by subjectively selecting a region in a given image that provided an optimal balance of maximum area and clarity of cell outlines. Blebs were then outlined manually and the software calculated the area of blebs. The different sessions are reported showing results for each lens according to the lens worn in the contralateral (contra) eye.Open eye sessions simulated the subjects normal ocular behavior during waking hours; closed eye sessions simulated ocular activity during duration of closed eye activity, such as sleeping. Results are reported as the mean percent difference between the stated test (senofilcon A) and the control lens (alphafilcon A, lotrafilcon B), after 20 minutes of wear, for each testing scenario.|20 minutes post-lens insertion|The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes.||Percent Difference of Bleb Area|Subject Eyes|Standard Deviation|Mean
760938|NCT00630305|Primary|Endothelial Bleb Areas on Cornea: Session A- Open Eye|Mean area of endothelial blebs in the following corneal locations: Central, Nasal, Temporal, Inferior, Superior. A masked observer performed the analysis by subjectively selecting a region in a given image that provided an optimal balance of maximum area and clarity of cell outlines. Blebs were then outlined manually and the software calculated the area of blebs. The different sessions are reported showing results for each lens according to the lens worn in the contralateral (contra) eye.Open eye sessions simulated the subjects normal ocular behavior during waking hours; closed eye sessions simulated ocular activity during duration of closed eye activity, such as sleeping. Results are reported as the mean percent difference between the stated test (senofilcon A) and the control lens (alphafilcon A, lotrafilcon B), after 20 minutes of wear, for each testing scenario.|20 minutes post-lens insertion|The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes.||Percent Difference of Bleb Area|Subjects Eyes|Standard Deviation|Mean
760939|NCT00630331|Secondary|Number of Subjects Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination|The solicited local and systemic reactogenicity were collected up to 7 days after vaccination for all three vaccine groups.|Up to 7 days post vaccination|Analysis was done on Safety population i.e. all subjects in the exposed population who provide post vaccination safety data.||Subjects|||Number
760940|NCT00630331|Secondary|Percentages of Subjects Achieving Seroconversion After One Vaccination of Either Cell-culture Derived or Egg-derived Influenza Vaccine or Placebo|As per the CBER guideline, seroconversion is defined as the percentage of subjects with a prevaccination HI titer <10, a postvaccination titer ≥40; or in subjects with prevaccination HI titer ≥10, a ≥4-fold increase in postvaccination HI antibody titer. According to CBER criteria, the lower limit of the two-sided 95% CI for the percentage of subjects achieving seroconversion for HI antibody titer at day 22 met exceeded 40%.|Three weeks after vaccination (day 22)|Analysis was done on a subset of subjects who constituted the PP immunogenicity population.||Percentages of subjects||95% Confidence Interval|Number
760941|NCT00630331|Secondary|Percentages of Subjects Who Achieved HI Titers ≥40 After One Vaccination of Either Cell-culture Derived or Egg-derived Influenza Vaccine or Placebo|Immunogenicity was measured as the percentage of subjects achieving HI titers ≥40 at baseline (day 1) and three weeks after (day 22) one vaccination of either cell-culture or egg-derived vaccine or placebo for each of the three influenza vaccine strains (A/H1N1, A/H3N2 and B), evaluated using hemagglutination inhibition (HI) egg-derived antigen assay. This criterion is met according to US (CBER) guideline if the lower limit of the two-sided 95% CI for the percentage of subjects achieving HI titers ≥40 is ≥70%.|Before vaccination (day 1) and three weeks after vaccination (day 22)|Analysis was done on a subset of subjects who constituted the PP immunogenicity population.||Percentages of subjects||95% Confidence Interval|Number
760942|NCT00630331|Secondary|Number of Days of Usual Activity (i.e. Job, School,Household/Family/Community Activities) Lost, Subset of Subjects With Virus-Confirmed-Influenza|The analysis was done among the subset of subjects in the per protocol efficacy population who had culture-confirmed influenza.|6 Months|Analysis was done on PP efficacy population.||Numebr of Days of Usual Activity Lost||Standard Deviation|Mean
760943|NCT00630331|Secondary|Number of Days of Usual Activity (i.e. Job, School,Household/Family/Community Activities) Lost Due to Influenza Disease, All Subjects|The number of subjects in this analysis included all subjects in the per protocol efficacy population.|6 Months|Analysis was done on PP efficacy population.||Numebr of Days of Usual Activity Lost||Standard Deviation|Mean
760944|NCT00630331|Secondary|Number of Medical Visits (Inpatient and Outpatient), Subset of Subjects With Virus-Confirmed-Influenza|The analysis was done among the subset of subjects in the per protocol efficacy population who had culture-confirmed influenza.|6 Months|Analysis was done of PP efficacy population.||Number of Medical Visits||Standard Deviation|Mean
760945|NCT00630331|Secondary|Number Of Medical Visits (Inpatient and Outpatient) Due to Influenza Illness or Symptoms of Influenza, All Subjects|The number of subjects in this analysis included all subjects in the per protocol efficacy population.|6 Months|Analysis was done of PP efficacy population.||Number of Medical Visits||Standard Deviation|Mean
760946|NCT00630331|Secondary|Influenza-Associated Days in Bed, Subset of Subjects With Virus-Confirmed- Influenza|The analysis was done among the subset of subjects in the per protocol efficacy population who had culture-confirmed influenza.|6 Months|Analysis was done on PP efficacy population.||Number of Days||Standard Deviation|Mean
760947|NCT00630331|Secondary|Influenza-Associated Days in Bed, All Subjects|The number of subjects in this analysis included all subjects in the per protocol efficacy population.|6 Months|Analysis was done on the PP efficacy population.||Number of Days||Standard Deviation|Mean
760948|NCT00630331|Secondary|Number of Subjects With Influenza Caused by Vaccine-like and Non-vaccine-like Strains|The vaccine efficacy of CCI and IVV vaccines was estimated relative to placebo as the number of subjected prevented against virus-confirmed symptomatic influenza A or B illness caused by vaccine-like and non-vaccine-like strains.|6 Months|Analysis was done on PP efficacy population.||Subjects|||Number
760949|NCT00630331|Secondary|Number of Subjects With Culture-confirmed Influenza Illness Caused by Non-Vaccine Like Strains|The vaccine efficacy of CCI and IVV vaccines was estimated relative to placebo group as the number of subjects prevented against virus-confirmed symptomatic influenza A or B illness caused by non-vaccine-like strains.|6 Months|Analysis was done on PP efficacy population.||Subjects|||Number
760950|NCT00630331|Primary|Number of Subjects With Culture-Confirmed Influenza Illness Caused by Vaccine-like Strains|The vaccine efficacy of CCI and IVV vaccines was estimated relative to Placebo group as the number of subjects prevented against virus-confirmed symptomatic influenza illness caused by each of three vaccine-like virus strains.|6 Months|Analysis was performed on per protocol (PP) efficacy population i.e. the subjects in the exposed efficacy population who correctly received the vaccine and provided evaluable swab samples at the relevant time points.||Subjects|||Number
760951|NCT00630344|Secondary|To Characterize the Toxicity Profile of RAD001 in Combination With Standard Dose Bicalutamide in Patients With Androgen Independent Prostate Cancer.||3 years||||||
760952|NCT00630344|Primary|To Determine the Best Overall Response and Duration of Response, Taking Into Consideration Measurable Disease, Bone Metastases and PSA.|The primary endpoint of this Phase II study is the best overall response, taking into consideration measurable disease, bone metastases, and PSA. A patient will be considered to have a favorable outcome if PSA declines in the absence of measurable disease without the appearance of new bone lesions, or if a response in measurable disease consistent with RECIST guidelines is observed, without an increase in PSA or the appearance of new bone lesions. Patients with stable disease lasting at least 6 months will also be considered to have favorable outcome.|3 years|||participants||95% Confidence Interval|Number
760953|NCT00630396|Secondary|90 Day Modified Rankin Scale Score|The modified Rankin Scale (mRS) was performed in person at the 90 day clinic follow-up appointment. The modified Rankin Scale is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke. The scale runs from 0-6. 0 represents no symptoms. 1 represents no significant disability. 2 represents slight disability. 3 represents moderate disability. 4 represents moderately severe disability. 5 represents severe disability. 6 represents death.|3 months|||Participants|||Number
761133|NCT00631540|Secondary|30-day Clinical Success|< 30% residual stenosis post-procedure by core lab analysis and no Major Adverse Events within 30 days.|30 Days|1 participant was lost to follow-up, 1 participant withdrew, 1 participant did not have core lab assessment.||Percentage of Participants|||Number
760954|NCT00630396|Secondary|Half-life of IV Minocycline|In eligible patients enrolled at Georgia Health Sciences University, blood samples were drawn for quantification of minocycline serum concentrations. This enabled the study team to determine the half life of the study drug.|For each subject blood samples were drawn before dose #1 and one hour after starting dose #1. Additional blood was drawn 1, 6, 12, 24, 48, and 72 hours after starting dose #6, which lasted approximately 6 days.|||hours|Participants|Standard Error|Mean
760955|NCT00630396|Primary|Maximally Tolerated Dose of IV Minocycline|Investigators closely monitored each subject for evidence of minocycline intolerance. All adverse events were immediately reported for a decision whether to discontinue the study medication and/or reduce the dose. A computer program was used to determine the maximum tolerated dose. After entering information regarding doses and expected toxicities, results for each subject as they were collected were entered. The computer program informed as to (de)escalation, or maintenance of the same dose in the subsequent cohort of enrolled patients.|3 days|||mg/kg|||Number
760956|NCT00630409|Secondary|Time to Progression|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Up to 40 months|Due to lack of follow-up, objective could not be determined.||participants||95% Confidence Interval|Median
760957|NCT00630409|Primary|Response Rate|Number of participants that experienced response/total number of participants per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan. Response was defined as Complete Response (CR), the disappearance of all target lesions; Partial Response (PR), a 30% or greater decrease in the sum of the longest diameter of target lesions.|Up to 18 weeks for individual; Up to 40 months for cohort|||percentage of participants|||Number
760958|NCT00630487|Secondary|Change From Baseline in Cardiovascular Risk Factors|Change in values of laboratory tests indicative of possible cardiovascular risk factors: high density lipoprotein (HDL), low density lipoprotein (LDL), triglycerides, N-terminal pro brain natriuretic peptide)|Baseline, Week 52, Week 78||||||
760959|NCT00630487|Secondary|Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D)|Participant self-administered questionnaire EQ-5D, a 2 part generic health status instrument. The first part consists of 5 descriptors of current health state: mobility, self care, usual activities, pain/discomfort and anxiety/depression. Scores are assigned on a three-level scale (1= no problem, 2= some problem, 3= extreme problem). The second part was an overall rating of the participant's current health state using a 20 cm Visual Analogue Scale (EQ-VAS) with endpoints labelled ‘best imaginable health state’ and ‘worst imaginable health state’.|Baseline, Week 52, Week 78||||||
760960|NCT00630487|Secondary|Change From Baseline in Short Form (36) Health Survey (SF36)|Participant self administered questionnaire that measures each of the following eight health concepts: Physical Functioning (PF); Role-Physical (RP); Bodily Pain (BP); General Health (GH); Vitality (VT); Social Functioning (SF); Role-Emotional (RE); Mental Health (MH) as well as a reported Health Transition item (HT). Scale range 0 to 100, higher scores indicate a better health-related quality of life.|Baseline, Week 52, Week 78||||||
760961|NCT00630487|Secondary|Change From Baseline in Quality of Life Assessment of Growth Hormone Deficiency in Adults (QoL-AGHDA)|Participant self administered questionnaire consisting of 25 items that evoke yes or no answers. A score of 1 is given to each item affirmed and these are summed to give the total score. The maximum score is 25, which represents a poor quality of life. The minimum score is 0, which represents a good quality of life.|Baseline, Week 52, Week 78||||||
760962|NCT00630487|Secondary|Change From Baseline in Homeostasis Model Assessment (HOMA)-Index|HOMA index is calculated by 1 of 2 methods: HOMA-Index = fasting insulin measured in microunits per milliliter (µU/ml) times fasting glucose measured in milligrams per deciliter mg/dl) divided by 405 or HOMA-Index = fasting insulin (µU/ml) times fasting glucose measured in millimoles per liter (mmol/l) divided by 22.5.|Baseline, Week 52, Week 78|Study terminated, no subjects were treated.|||||
760963|NCT00630487|Secondary|Change From Baseline in Safety Laboratory Assessments|Prespecified safety laboratory assessments evaluated for change or no change from baseline. Possible responses were Yes/No.|Baseline, Week 52, Week 78||||||
760964|NCT00630487|Secondary|Change in Executive Function and Memory in Subgroups|Change in executive function and memory in subgroups. Subgroup 1: isolated Growth Hormone Deficiency (GHD)due to surgery and/or irradiation of pituitary adenoma and suprasellar tumors. Subgroup 2: history of traumatic brain injury (TBI) or subarachnoid hemorrhage (SAH). Median reaction time, the total number of errors, the number of omissions and the number of false positive reactions.|Baseline, Week 52, Week 78|Study terminated, no subjects were treated.|||||
760965|NCT00630487|Secondary|Change From Baseline in Heart Rate|The use of an automated device for measuring pulse rate was acceptable, although, when done manually, pulse rate was measured in the brachial/radial artery for at least 30 seconds.|Baseline, Week 52, Week 78|Study terminated, no subjects were treated.|||||
760966|NCT00630487|Secondary|Change From Baseline in Blood Pressure|Blood pressure was measured seated, the subject's arm supported at the level of the heart, and recorded to the nearest mm Hg. The same arm (preferably the dominant arm) was used throughout the trial. The subject was seated for 5 minutes before the blood pressure was obtained. Use of an automated device could have been used for measuring blood pressure.|Baseline, Week 52, Week 78|Study terminated, no subjects were treated.|||||
760967|NCT00630487|Secondary|Change From Baseline in Alertness (Testbatterie Zur Aufmerksamkeitsprüfung [TAP]) and Memory (Auditory Verbal Learning Test [AVLT])|Alertness: software-based neuropsychological assessment for response time and errors. Memory: analysis of learning and retention using 5-trial presentation of 15-word list (A), single presentation of interference list (B), 2 postinterference recall trials - 1 immediate, 1 delayed - and recognition of the target words with distractors (C). Performance variables were immediate word span under overload conditions, final acquisition level, amount learned in 5 trials, interference, delayed recall, and recognition (implicit learning).|Baseline, Week 52, Week 78|Study terminated, no subjects were treated.|||||
760968|NCT00630487|Secondary|Change From Baseline in Anthropometric Parameters (Waist Circumference)||Baseline, 52 weeks, 78 weeks|Study terminated, no subjects were treated.|||||
760969|NCT00630487|Secondary|Change From Baseline in Anthropometric Parameters (Weight)||Baseline, 52 weeks, 78 weeks|Study terminated, no subjects were treated.|||||
760970|NCT00630487|Secondary|Change From Baseline in Anthropometric Parameters (Height)||Baseline, 52 weeks, 78 weeks|Study terminated, no subjects were treated.|||||
760971|NCT00630487|Secondary|Change in Visceral Fat Mass in Subgroups|Change in visceral fat mass in subgroups. Subgroup 1: isolated GHD due to surgery and/or irradiation of pituitary adenoma and suprasellar tumors. Subgroup 2: history of traumatic brain injury (TBI) or subarachnoid hemorrhage (SAH).|Baseline, 52 weeks, 78 weeks|Study terminated, no subjects were treated.|||||
760972|NCT00630487|Primary|Change of Visceral Fat Mass Assessed by Magnetic Resonance Imaging Scanning (MRI)|Fat measurements carried out with the subjects lying in a supine position in a MRI scanner. Measurements of regional body fat obtained between the level of the coccygeal bone and the 2nd or 3rd lumbar vertebra.|Baseline, 52 weeks|Study terminated, no subjects were treated.|||||
760973|NCT00630539|Secondary|Mean Change From Baseline in Percentage of Parabasal Cells in the Maturation Index||Week 4|ITT||percentage of parabasal cells||Standard Deviation|Mean
760974|NCT00630539|Secondary|Mean Change From Baseline in Sex Hormone Binding Globulin Levels||Week 12|ITT||nmol/L||Standard Deviation|Mean
760975|NCT00630539|Secondary|Mean Change From Baseline in Follicle Stimulating Hormone Levels||Week 12|ITT||U/L||Standard Deviation|Mean
760976|NCT00630539|Secondary|Mean Change From Baseline in Luteinizing Hormone Levels||Week 12|ITT||U/L||Standard Deviation|Mean
760977|NCT00630539|Secondary|Mean Change From Baseline in Estradiol Levels||Week 12|ITT||nmol/L||Standard Deviation|Mean
760978|NCT00630539|Secondary|Mean Change From Baseline in Percentage of Superficial Cells in the Maturation Index||Week 4|ITT||percentage of superficial cells||Standard Deviation|Mean
760979|NCT00630539|Secondary|Mean Change From Baseline in Vaginal pH||Week 4|ITT||pH||Standard Deviation|Mean
760980|NCT00630539|Secondary|Visual Evaluation of Vagina (by Gynecological Examination)||Screening & Week 12|ITT||percentage of subjects|||Number
760981|NCT00630539|Primary|Mean Change From Baseline in Vaginal pH||12 weeks|ITT||pH||Standard Deviation|Mean
760982|NCT00630539|Primary|Mean Change From Baseline in Percentage of Superficial Cells in Maturation Index of the Vaginal Smear||12 weeks|ITT||percentage of superficial cells||Standard Deviation|Mean
760983|NCT00630539|Primary|Mean Change From Baseline in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear||12 weeks|ITT||percentage of parabasal cells||Standard Deviation|Mean
760984|NCT00630734|Secondary|Pravastatin + Darunavir/Ritonavir: Pravastatin Maximum Plasma Concentration (Cmax)||0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24 hours post-dose|The population analyzed included participants who completed the pravastatin alone phase and the pravastatin + darunavir/ritonavir phase of the study.||ng/ml||Standard Deviation|Mean
760985|NCT00630734|Secondary|Pravastatin + Darunavir/Ritonavir: Pravastatin Area Under the Plasma Concentration-time Curve (AUC) Over the Dosing Interval|Dosing interval of 24 hours|0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24 hours post-dose|The population analyzed included participants who completed the pravastatin alone phase and the pravastatin + darunavir/ritonavir phase of the study.||ng*h/ml||Standard Deviation|Mean
760986|NCT00630734|Secondary|Pravastatin Alone: Pravastatin Maximum Plasma Concentration (Cmax)||0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24 hours post-dose|The population analyzed included participants who completed the pravastatin alone phase and the pravastatin + darunavir/ritonavir phase of the study.||ng/ml||Standard Deviation|Mean
760987|NCT00630734|Secondary|Pravastatin Alone: Pravastatin Area Under the Plasma Concentration-time Curve (AUC) Over the Dosing Interval|Dosing interval of 24 hours|0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24 hours post-dose|The population analyzed included participants who completed the pravastatin alone phase and the pravastatin + darunavir/ritonavir phase of the study.||ng*h/ml||Standard Deviation|Mean
760988|NCT00630734|Other Pre-specified|Ritonavir Maximum Plasma Concentration (Cmax)|Cmax of ritonavir over a 12-hour dosing interval|0,1, 2, 3, 4, 5, 6, 8, 12 hours post-dose|The population analyzed included participants who completed the pravastatin alone phase and the pravastatin + darunavir/ritonavir phase of the study.||ng/ml||Standard Deviation|Mean
760989|NCT00630734|Other Pre-specified|Ritonavir Area Under the Plasma Concentration-time Curve (AUC) Over the Dosing Interval|AUC of ritonavir over a 12-hour dosing interval.|0, 1, 2, 3, 4, 5, 6, 8, 12 hours post-dose|The population analyzed included participants who completed the pravastatin alone phase and the pravastatin + darunavir/ritonavir phase of the study.||ng*hr/ml||Standard Deviation|Mean
760990|NCT00630734|Other Pre-specified|Darunavir Maximum Plasma Concentration (Cmax)|Cmax of darunavir over a 12-hour dosing interval|0, 1, 2, 3, 4, 5, 6, 8, 12 hours post-dose|The population analyzed included participants who completed the pravastatin alone phase and the pravastatin + darunavir/ritonavir phase of the study.||ng/ml||Standard Deviation|Mean
760991|NCT00630734|Other Pre-specified|Darunavir Area Under the Plasma Concentration-time Curve (AUC) Over the Dosing Interval|AUC of darunavir over a 12-hour dosing interval.|0, 1, 2, 3, 4, 5, 6, 8, 12 hours post-dose|The population analyzed included participants who completed the pravastatin alone phase and the pravastatin + darunavir/ritonavir phase of the study.||ng*h/ml||Standard Deviation|Mean
760992|NCT00630734|Primary|Relative Change in Pravastatin Maximum Plasma Concentration (Cmax)|Cmax of pravastatin when administered with darunavir/ritonavir divided by the Cmax of pravastatin when administered alone.|0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24 hours post-dose|The population analyzed included participants who completed the pravastatin alone phase and the pravastatin + darunavir/ritonavir phase of the study.||ng/ml||95% Confidence Interval|Mean
760993|NCT00630734|Primary|Relative Change in Pravastatin Area Under the Plasma Concentration-time Curve (AUC) Over the Dosing Interval|AUC of pravastatin when administered with darunavir/ritonavir divided by AUC of pravastatin when administered alone. The AUC was measured over a 24-hour dosing interval.|0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24 hours post-dose|The population analyzed included participants who completed the pravastatin alone phase and the pravastatin + darunavir/ritonavir phase of the study.||ng*hr/ml||95% Confidence Interval|Mean
760994|NCT00630747|Primary|Change From Baseline in Mean Distance Walked in the 6-minute Walk Test (6MWT) at Week 105|Determined on a walking course. The change was calculated as Week 105 minus baseline.|Baseline and at Week 105|All participants for whom distance walked was recorded at baseline and at Week 105.||meters (m)||Standard Error|Mean
760995|NCT00630747|Secondary|Change From Baseline in Mean Cardiac Left Ventricular Mass Index (LVMI) at Week 105|Determined by echocardiogram. LVMI indexed to body surface area (g/m^2). The change was calculated as Week 105 minus baseline.|Baseline and at Week 105|All participants for whom cardiac LVM were recorded at baseline and at Week 105.||g/m^2||Standard Error|Mean
760996|NCT00630747|Secondary|Change From Baseline in Mean Normalized Urine Glycosaminoglycans (GAG) Levels at Week 105|Determined by urine testing. The change was calculated as Week 105 minus baseline.|Baseline and at Week 105|All participants for whom normalized urine GAG levels were recorded at baseline and at Week 105.||mcg GAG/mg creatinine||Standard Error|Mean
760997|NCT00630747|Secondary|Change From Baseline in Mean Combined Liver and Spleen Volume at Week 105|Determined by Magnetic Resonance Imaging (MRI). The change was calculated as Week 105 minus baseline.|Baseline and at Week 105|All participants for whom combined liver and spleen volume were recorded at baseline and at Week 105.||cubic centimeters (cc)||Standard Error|Mean
760998|NCT00630747|Secondary|Change From Baseline in Mean Passive Joint Range of Motion (JROM) at Week 105|Change was calculated as Week 105 minus baseline. Global JROM (% normal range of motion) is the average of 11 ratios multiplied by 100. Ratios are Left/Right means of passive range of motion in Shoulder (Flexion/Extension, Abduction, Internal/External Rotation), Elbow (Flexion/Extension), Wrist (Flexion/Extension), Index Finger (Flexion/Extension [Combined Metacarpophalangeal joint (MCP), Proximal interphalangeal joint (PIP), Distal interphalangeal joint (DIP) motion]), Hip (Flexion/Extension, Abduction, Internal/External Rotation), Knee (Flexion/Extension), and Ankle (Dorsiflexion) divided by the normal range (American Academy of Orthopedic Surgeons and American Medical Association).|Baseline and at Week 105|All participants for whom passive JROM were recorded at baseline and at Week 105.||percentage of JROM||Standard Error|Mean
760999|NCT00630747|Primary|Change From Baseline in Mean Percent Predicted Forced Vital Capacity (FVC) at Week 105|Determined by spirometry. The change is calculated as Week 105 minus baseline.|Baseline and at Week 105|All participants for whom percent predicted FVC were recorded at baseline and at Week 105.||percent predicted FVC||Standard Error|Mean
761000|NCT00630786|Secondary|Number of Participants With Post-baseline Laboratory Values Grade 3 or Higher|Laboratory values were assessed using the National Cancer Institute (NCI) Common Toxicity Criteria (version 3.0) according to the following: 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Life-threatening; 5 = Fatal.|From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks.|Safety Analysis Set, including all randomized patients who received at least one dose of investigational drug.||participants|||Number
761001|NCT00630786|Secondary|Number of Participants With Adverse Events (AEs)|"An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment, and includes any such occurrence (eg, sign, symptom, or diagnosis) or worsening of a pre-existing medical condition from the time that a participant has signed informed consent to the time of initiation of investigational product. The severity of AEs was graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, according to the following:
= Mild: Aware of sign or symptom, but easily tolerated
= Moderate: Discomfort enough to cause interference with usual activity;
= Severe: Incapacitating with inability to work or do usual activity;
= Life-threatening: an event in which the patient was, in the view of the investigator, at risk of death at the time of the event;
= Fatal."|From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks.|Safety Analysis Set, including all randomized patients who received at least one dose of investigational drug.||participants|||Number
761002|NCT00630786|Secondary|Number of Participants With Anti-therapeutic Antibodies|Number of participants with human anti-panitumumab antibodies (HAPA) or anti-conatumumab antibodies measured by immunoassay.|Antibody samples were collected at weeks 1, 7, and 23 and every 6 months thereafter during treatment, and at the safety follow-up and follow-up visits. The mean follow-up time was 35.7 weeks.|Safety analysis set, including all randomized patients who received at least 1 dose of investigational product. N indicates the number of patients with immunoassay results at the specified time points.||participants|||Number
761003|NCT00630786|Secondary|Duation of Response|The interval in days from the first confirmed objective response to disease progression per the modified RECIST criteria or death. Calculated only for participants with an objective response.|Participants were evaluated for tumor response until radiographic disease progression or until the participant began another anticancer treatment (up to a maximum of 55.6 weeks).|Patients with an overall objective response|||||
761004|NCT00630786|Secondary|Time to Response|The interval in days from the first dose of study therapy to the date of first confirmed objective response. Calculated only for participants with an objective response.|Participants were evaluated for tumor response until radiographic disease progression or until the participant began another anticancer treatment (up to a maximum of 55.6 weeks).|Patients with an overall objective response|||||
761005|NCT00630786|Secondary|Number of Participants With Disease Control|Disease control defined as participants with an overall objective response of complete response (CR), partial response (PR), or stable disease during the treatment period, assessed by the investigator according to the modified Response Evaluation Criteria in Solid Tumors (RECIST). Responses were confirmed no less than 4 weeks after the criteria for response were first met. CR defined as the disappearance of all target and non-target lesions and no new lesions. PR defined as either the disappearance of all target lesions with the persistence of one or more non-target lesion(s), or, at least a 30% decrease in the sum of the longest diameter (SLD) of target lesions, taking as reference the Baseline SLD and the disappearance of all or the persistence of 1 or more non-target lesions. Stable disease defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the nadir LD since the treatment started.|Participants were evaluated for tumor response until radiographic disease progression or until the participant began another anticancer treatment (up to a maximum of 55.6 weeks).|Subset of the Safety Analysis Set, composed of all enrolled participants who received at least one dose of study drug, who had known Kirsten Rat Sarcoma Virus Oncogene (KRAS) status.||participants|||Number
761006|NCT00630786|Secondary|Overall Survival|Kaplan-Meier estimate of time from enrollment to death from any cause|Participants were evaluated for tumor response until radiographic disease progression or until the participant began another anticancer treatment (up to a maximum of 55.6 weeks).|Subset of the Safety Analysis Set, composed of all enrolled participants who received at least one dose of study drug, who had known Kirsten Rat Sarcoma Virus Oncogene (KRAS) status.||months||95% Confidence Interval|Median
761134|NCT00631540|Secondary|Acute Procedural Success|< 30% residual stenosis post-procedure by core lab analysis and no Major Adverse Events before discharge.|Prior to Discharge|1 participant did not have core lab assessment for stenosis.||Percentage of Participants|||Number
761007|NCT00630786|Secondary|Progression-free Survival|Kaplan-Meier estimate of the median time from enrollment to death from any cause or disease progression. Progressive disease is defined as at least a 20% increase in the sum of the longest diameters (SLD) of target lesions, taking as reference the nadir SLD recorded since the treatment started, or the appearance of one or more new lesions, or the unequivocal progression of existing non-target lesions.|Participants were evaluated for tumor response until radiographic disease progression or until the participant began another anticancer treatment (up to a maximum of 55.6 weeks).|Subset of the Safety Analysis Set, composed of all enrolled participants who received at least one dose of study drug who had known Kirsten Rat Sarcoma Virus Oncogene (KRAS) status.||weeks||95% Confidence Interval|Median
761008|NCT00630786|Primary|Number of Participants With an Objective Response|An overall objective response of either a confirmed complete response or partial response, where the overall objective response was equivalent to the best overall response recorded for each participant from enrollment until disease progression or recurrence. Tumor response was assessed by the investigator according to the modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. Responses were confirmed no less than 4 weeks after the criteria for response were first met. Complete response defined as the disappearance of all target and non-target lesions and no new lesions. Partial response defined as either the disappearance of all target lesions with the persistence of one or more non-target lesion(s), or, at least a 30% decrease in the sum of the longest diameter (SLD) of target lesions, taking as reference the Baseline SLD and the disappearance of all or the persistence of 1 or more non-target lesions.|Participants were evaluated for tumor response until radiographic disease progression or until the participant began another anticancer treatment (up to a maximum of 55.6 weeks).|Subset of the Safety Analysis Set, composed of all enrolled participants who received at least one dose of study drug who had known Kirsten Rat Sarcoma Virus Oncogene (KRAS) status and Baseline measurable disease.||participants|||Number
761009|NCT00630786|Primary|Part 1: Number of Participants With Dose-limiting Toxicities|"A dose-limiting toxicity (DLT) was defined as any grade 3 or 4 conatumumab-related or combination (panitumumab and conatumumab)-related adverse event, or grade 3 or 4 laboratory abnormality that occurred during the first 4 weeks (28 days) of treatment with panitumumab and conatumumab. Anemia and lymphopenia were not considered DLTs.
Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was used to grade all adverse events and toxicities."|4 weeks|DLT-evaluable patients were those who received ≥ 2 doses of panitumumab and conatumumab as scheduled (ie, weeks 1 and 3) and completed 4 weeks (28 days) of treatment, or had a DLT within the first 4 weeks (28 days) of treatment.||participants|||Number
761010|NCT00630825|Secondary|Pharmacokinetics (PK) of LY2189265 - Area Under the Concentration Time Curve (AUC)|The population mean estimates and standard deviations were calculated for pharmacokinetic parameters (area under the concentration time curve [AUC] at steady state from time zero to 168 hours after study drug administration).|Time zero to 168 hours after study drug administration at 4, 8, and 16 weeks|Participants who received at least one dose of LY2189265 with evaluable LY2189265 concentration data.||nanograms*hour/milliliter (ng*h/mL)||Standard Deviation|Mean
761011|NCT00630825|Secondary|Validation of the Psychometric Properties of the Perceptions About Medications - Diabetes, Short Version (PAM-D-S) Questionnaire|This purpose of this outcome measure was to validate the PAM-D-S questionnaire for future use. Please refer to Outcome Measure #14 for a description of the PAM-D-S questionnaire and results collected. A preliminary analysis indicated modifications to the questionnaire were required and further study is necessary to complete the validation. Therefore, the PAM-D-S questionnaire was not validated as a part of Study H9X-MC-GBCJ.|Baseline and 4 and 8 and 16 weeks|The items in the Perceptions about Medications - Diabetes, Short Version (PAM-D-S) questionnaire were exploratory items taken from a Diabetes Medicines Survey and had not been validated as a scale. Therefore, no participants were analyzed for validation purposes.|||||
761012|NCT00630825|Secondary|Participants Perception of Medication Effectiveness Using the Perceptions About Medications - Diabetes, Short Version (PAM-D-S) Questionnaire|The Perceptions about Medications - Diabetes, Short Version (PAM-D-S) questionnaire consisted of: 2 items in which respondents were asked about their satisfaction with their diabetes medication over the past week using a 6–point scale ranging from 1 “completely dissatisfied” to 6 “completely satisfied”; 10 items in which respondents were asked about the effectiveness of their diabetes medications in the past week using a 4-point scale ranging from 1 “all of the time” to 4 “none of the time”; and 15 items asking respondents to indicate the frequency of physical side effects in the past week using a 4-point scale ranging from 1 “all of the time” to 4 “none of the time.” These items were exploratory items taken from a Diabetes Medicines Survey and had not been validated as a scale. The percentage of participants that rated their general health as good or better are summarized.|Baseline and 4 and 8 and 16 weeks|Participants in the per-protocol population with evaluable PAM-D-S questionnaire data. The per-protocol population consisted of participants who received at least one dose of study medication, had no significant protocol violations, completed the double-blind treatment phase, and were compliant with the study drug.||percentage of participants|||Number
761013|NCT00630825|Secondary|Change From Baseline in Lipids|Lipids include total cholesterol, low-density lipoprotein (LDL)-cholesterol, high-density lipoprotein (HDL)-cholesterol, and triglycerides.|Baseline, 16 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable lipid data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||millimoles per liter (mmol/L)||Full Range|Median
761014|NCT00630825|Secondary|Rate of Hypoglycemia Per 30 Days|Hypoglycemic episodes are defined as an event which is associated with reported signs and/or symptoms of hypoglycemia (for example, sweating, shakiness, tachycardia, etc.) or a documented blood glucose (BG) concentration of ≤70 milligrams per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]), even if it was not associated with symptoms, signs, or treatment. The rate is the average number of days out of 30 that a participant reported hypoglycemia. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 16 weeks|Participants who received at least one dose of LY2189265 or Placebo.||events per participant per 30 days||Standard Deviation|Mean
761135|NCT00631540|Secondary|Technical Success|Successful delivery and deployment of a Formula™ Balloon-Expandable Stent at index procedure.|Prior to Discharge|||Percentage of Participants|||Number
790687|NCT00877929|Secondary|BP Control (SBP<140 mmHg, DBP<90 mmHg) at Two Weeks|Mean seated SBP<140 mmHg and mean seated DBP<90 mmHg|Baseline, week 2|Treated set using LOCF||participants|||Number
761015|NCT00630825|Secondary|Number of Participants With a Hypoglycemic Event|A documented hypoglycemic episode is defined as an event which is associated with a measured blood glucose of ≤70 milligrams per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]), even if it was not associated with symptoms, signs, or treatment. A severe hypoglycemic episode is defined as an event with a measured blood glucose of <50mg/dL. Participant reports of hypoglycemic events were collected at the beginning of each visit starting at Baseline. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 4, 8, and 16 weeks|Participants who received at least one dose of LY2189265 or Placebo.||participants|||Number
761016|NCT00630825|Secondary|Change From Baseline in Gastroparesis Cardinal Symptom Index (GCSI) Scores|Gastroparesis Cardinal Symptom Index (GCSI) is a participant-completed questionnaire designed to assess the severity of symptoms consistent with delayed gastric emptying (nausea/vomiting, abdominal bloating, and stomach fullness) at each study visit. GCSI scores ranged from 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, to 5=very severe.|Baseline and 4 and 8 and 16 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable Gastroparesis Cardinal Symptom Index (GCSI) questionnaire data. For Week 16 data, last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||units on a scale||Standard Deviation|Mean
761017|NCT00630825|Secondary|Nausea and Dyspepsia Measured by Visual Analog Scale|Participants were asked to score nausea and dyspepsia (abdominal pain and bloating) on a scale of 0 (none) to 100 after the largest meal of the day.|One week before and one week after each of the Baseline and Week 4 and Week 8 and Week 16 visits|Participants who received at least one dose of LY2189265 or Placebo with evaluable nausea or dyspepsia (abdominal pain and bloating) data.||units on a scale||Standard Deviation|Mean
761018|NCT00630825|Secondary|Change From Baseline in Waist Circumference|Mean change from baseline in waist circumference (a measure of central obesity).|Baseline, 16 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable waist circumference data. For Week 16 data, last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||centimeters (cm)||Standard Deviation|Mean
761019|NCT00630825|Secondary|Change From Baseline in Body Weight|LS means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusting for treatment, combination of oral medications, and baseline.|Baseline, 4, 8, and 16 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable body weight data. For Week 16 data, last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||kilograms (kg)||Standard Error|Least Squares Mean
761020|NCT00630825|Secondary|Percentage of Participants Achieving a Glycosylated Hemoglobin (HbA1c) of <7% or ≤6.5%|Percentages of participants who achieved glycosylated hemoglobin (HbA1c) levels of <7% or ≤6.5% were analyzed with a logistic regression model with baseline, combination of oral medications, and treatment as factors included in the model.|Baseline and 4 and 8 and 16 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable glycosylated hemoglobin (HbA1c) data. For Week 16 data, last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||percentage of participants|||Number
761021|NCT00630825|Secondary|Change From Baseline in Beta (β)-Cell Function and Insulin Sensitivity as Estimated by the Updated Homeostasis Model Assessment Method (HOMA2)|Homeostasis Model Assessment tool (HOMA2) of β-cell function is a technique for estimating beta-cell function (HOMA2-%B) and insulin sensitivity (HOMA2-%S) using basal serum glucose, and c-peptide concentrations. A fasting blood glucose, c-peptide, and serum insulin level were drawn for purposes of this determination just prior to the mixed meal test.|Baseline, 16 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable HOMA2-%B or HOMA2-%S data.||percentage of HOMA2||Standard Deviation|Mean
761022|NCT00630825|Secondary|Change From Baseline in Daily Mean Blood Glucose Values From the 8-point Self Monitored Blood Glucose (SMBG) Profiles|Change from baseline in mean daily blood glucose values were measured using self-monitored blood glucose (SMBG) data collected at the following 8 time points: pre-morning meal; 2 hours post-morning meal; pre-midday meal; 2 hours post-midday meal; pre-evening meal; 2 hours post-evening meal; bedtime; and 2:00 am. The daily mean was calculated as the average of the 8 blood glucose values collected on a particular day. Least Squares (LS) means of change from baseline of the mean of the 8 time points (Daily Mean) were calculated using analysis of covariance (ANCOVA) adjusting for treatment, combination of oral medications, and baseline.|2 separate days in the week preceding the Baseline, Week 4, Week 8, and Week 16 visits.|Participants who received at least one dose of LY2189265 or Placebo with evaluable blood glucose (SMBG) data. For Week 16 data, last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
761023|NCT00630825|Secondary|Meal Test Glucose Excursion (Change in Blood Glucose to Test Meal)|Glucose excursion in response to a standardized solid mixed meal test was evaluated at baseline (randomization) and at Week 16, or at early termination. Each of the 2 standardized meal tests required participants to fast starting at 2200 hours the night prior to the test. A standardized breakfast meal was provided to the participant (approximately 550 kilocalorie [Kcal], 103 grams [g] carbohydrates, 22 g protein, and 8.5 g fat) and was to be consumed within 15 minutes. Serial venous blood samples were taken at the start of the meal (fasting [0]) and 30, 60, 90, 120, and 180 minutes after the start of the meal. Least Squares (LS) means of change in mean glucose area under the curve excursion following a test meal were calculated adjusting for treatment, combination of oral medications, and baseline.|Baseline and 16 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable glucose excursion data.||millimoles per liter (mmol/L)*minute||Standard Deviation|Mean
761035|NCT00630864|Other Pre-specified|Change From Baseline in Tricuspid Pulmonary Artery Systolic Pressure (PASP) at Month 6, Month 12|Systolic right ventricular pressure can be estimated on echocardiography by adding right atrial pressure (RAP) to the trans-tricuspid gradient derived from the tricuspid regurgitation velocity.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were analyzed for the specific category.||millimeter of mercury (mmHg)||Standard Deviation|Mean
761024|NCT00630825|Secondary|Change From Baseline in Fasting Blood Glucose|Fasting blood glucose is a test to determine how much glucose (sugar) is in a blood sample after an overnight fast. Least Squares (LS) means of change were calculated using analysis of covariance (ANCOVA) adjusting for treatment, combination of oral medications, and baseline.|Baseline, 16 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable fasting blood glucose data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
761025|NCT00630825|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) in Overweight and Obese Participants With Type 2 Diabetes Mellitus|Once weekly injections of LY2189265 (titrated and non-titrated doses) compared to placebo on blood glucose were evaluated. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusting for treatment, combination of oral medications, and baseline glycosylated hemoglobin (HbA1c).|Baseline, 16 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable glycosylated hemoglobin (HbA1c) data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
761026|NCT00630838|Primary|Severity of Clinical Episodes of HAEC|The severity of clinical episodes of HAEC will be stratified into three grades (mild, moderate, or severe). Grades of severity reported are based on first episodes.|6 months|||participants|||Number
761027|NCT00630838|Primary|Number of Patients Diagnosed With Hirschsprung-associated Enterocolitis (HAEC).|The primary outcome measure is reporting the number of participants diagnosed with Hirschsprung-associated enterocolitis (HAEC) after pullthrough procedure.|6 months post-pullthrough|||participants|||Number
761028|NCT00630864|Other Pre-specified|Change From Baseline in Troponin I Levels at Week 2, Week 6 , Month 3, Month 6, Month 12|Troponin I is a cardiac injury biomarker. Higher concentrations of this marker in blood are associated with heart injury.|Baseline, Week 2, Week 6 , Month 3, Month 6, Month 12|ITT population. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were analyzed for the specific category. Data prior Month 6 were not anticipated to be informative hence were not analyzed.||nanogram/mL||Standard Deviation|Mean
761029|NCT00630864|Other Pre-specified|Change From Baseline in Karnofsky Performance Status Scale at Month 6, Month 12|Karnofsky performance score is used to quantify participant’s general well-being and activities of daily life and participants are classified based on their functional impairment. Karnofsky performance score is 11 level score which ranges between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were analyzed for the specific category.||units on a scale||Standard Deviation|Mean
761030|NCT00630864|Other Pre-specified|Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) at Week 2, Week 6, Month 3, Month 6, Month 12|NT-proBNP was a cardiac marker which had the prognostic value for participants with heart failure or left ventricular dysfunction. Higher level of the marker was indicative of heart damage.|Baseline, Week 2, Week 6, Month 3, Month 6, Month 12|ITT population. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were analyzed for the specific category. Data prior Month 6 were not anticipated to be informative hence were not analyzed.||picogram/mL (pg/mL)||Standard Deviation|Mean
761031|NCT00630864|Other Pre-specified|Change From Baseline in Left Atrial (LA) Volume Index at Month 6, Month 12|LA volume index (LAVI), was the value of LA volume divided by body surface area, to measure LA size.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were analyzed for the specific category.||milliliter/square meter (mL/m^2)||Standard Deviation|Mean
761032|NCT00630864|Other Pre-specified|Change From Baseline in Left Ventricular (LV) Mass/Voltage Ratio at Month 6, Month 12|LV mass was calculated from the product of the myocardial volume and specific gravity of heart muscle, estimated by echocardiography. QRS score (the sum of QRS voltages in the peripheral leads) was used as an index of “electrical” LV mass.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were analyzed for the specific category.||gram/millivolt||Standard Deviation|Mean
761033|NCT00630864|Other Pre-specified|Change From Baseline in e:e’ Lateral Ratio , Ratio of Peak Mitral Early Diastolic and Atrial Contraction Velocity (E/A Ratio) at Month 6, Month 12|Doppler echocardiography was a procedure which used ultrasound technology to examine the heart. Ratio of early (E) diastolic transmitral flow velocity and atrial (A) contraction velocity (E/A) and ratio of the early (E) diastolic transmitral flow velocity to the mitral annular velocity (e’) (E/e’) were estimated.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were analyzed for the specific category.||ratio||Standard Deviation|Mean
761034|NCT00630864|Other Pre-specified|Change From Baseline in Doppler Data at Month 6, Month 12|Doppler echocardiography was a procedure which used ultrasound technology to examine the heart. Doppler principle was used to measure the mitral peak early (E) diastolic transmitral flow, mitral peak atrial (A) contraction velocity and annular velocities at the lateral and septal areas of the mitral annulus. s': systolic velocity during ejection, e': early diastolic mitral annular velocity, a': late diastolic mitral annular velocity.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were analyzed for the specific category.||centimeter per second (cm/sec)||Standard Deviation|Mean
761214|NCT00638222|Secondary|Plasma C-reactive Protein||week 1, 8, 11, 18||||||
761215|NCT00638222|Secondary|Interleukin-6||week 1, 8, 11, 18||||||
761216|NCT00638222|Secondary|Oxidized LDL||week 1, 8, 11, 18||||||
761217|NCT00638222|Primary|Micro T- Wave Alternans||week 1, 8, 11, 18||||||
761036|NCT00630864|Other Pre-specified|Change From Baseline in Tricuspid Peak Velocity at Month 6, Month 12|Tricuspid peak velocity was measured by echocardiography.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were analyzed for the specific category.||meter per second (m/sec)||Standard Deviation|Mean
761037|NCT00630864|Other Pre-specified|Change From Baseline in Aortic Annulus Diameter at Month 6, Month 12|The diameter at the base of the aortic root, the basal ring, is also called the aortic annulus diameter.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were analyzed for the specific category.||centimeter (cm)||Standard Deviation|Mean
761038|NCT00630864|Other Pre-specified|Change From Baseline in Isovolumetric Relaxation Time (IVRT), Mitral Deceleration Time at Month 6, Month 12|Doppler echocardiography was a procedure which used ultrasound technology to examine the heart. IVRT is the time between the closure of the aortic valve and the opening of the mitral valve. Mitral deceleration time (MDT) was the time taken from the maximum E point wave to baseline. E wave arises due to early diastolic filling.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were analyzed for the specific category.||msec||Standard Deviation|Mean
761039|NCT00630864|Other Pre-specified|Change From Baseline in Left Ventricular Mass (LVM) at Month 6, Month 12|LV mass was calculated from the product of the myocardial volume and specific gravity of heart muscle, estimated by echocardiography. Increased LVM was associated with cardiovascular morbidity and mortality.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were analyzed for the specific category.||gram||Standard Deviation|Mean
761040|NCT00630864|Other Pre-specified|Change From Baseline in Left Ventricular (LV) Ejection Fraction at Month 6, Month 12|Cardiac MRI was done to measure left ventricular ejection fraction (LVEF) which was the fraction of the end-diastolic volume (EDV) that was ejected out of left ventricle with each contraction.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were analyzed for the specific category.||percentage of EDV||Standard Deviation|Mean
761041|NCT00630864|Other Pre-specified|Change From Baseline in Fractional Shortening at Month 6, Month 12|Fractional shortening (FS) is the fraction of any diastolic dimension that is lost in systole. Percent of FS was calculated as difference between end-diastolic dimension (EDD) and end-systolic dimension (EDS) divided by EDD.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were analyzed for the specific category.||percentage of EDD||Standard Deviation|Mean
761042|NCT00630864|Other Pre-specified|Change From Baseline in Left Ventricular (LV) End Systolic Volume, Left Ventricle (LV) Stroke Volume at Month 6, Month 12|Cardiac MRI was done to measure left ventricular (LV) end systolic volume, left ventricle (LV) stroke volume.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were analyzed for the specific category.||milliliter (mL)||Standard Deviation|Mean
761043|NCT00630864|Other Pre-specified|Change From Baseline in Left Atrial Volume at Month 6, Month 12|Left atrial volume was measured by echocardiography.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were analyzed for the specific category.||cubic centimeter (cc)||Standard Deviation|Mean
761044|NCT00630864|Other Pre-specified|Change From Baseline in Echocardiography (ECHO) Parameters at Month 6, Month 12|Echocardiography was used to measure interventricular septal thickness (IVST), posterior left ventricular wall thickness (PLVWT), right ventricular wall thickness (RVWT), left atrial diameter (LAD): anterior-posterior (ant-post), medio-lateral, superior-inferior (sup-inf) and left ventricular end diastolic diameter (LVED), relative LV wall thickness (RLVWT).|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were analyzed for the specific category.||millimeter (mm)||Standard Deviation|Mean
761045|NCT00630864|Other Pre-specified|Change From Baseline in Overall Quality of Life and Individual Domains of the Short-form-36 (SF-36) at Month 6, Month 12|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health and two total scores (physical component summary [PCS] and mental component summary [MCS]. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were analyzed for the specific category.||units on a scale||Standard Deviation|Mean
761046|NCT00630864|Other Pre-specified|Change From Baseline in Modified Body Mass Index (mBMI) at Month 6, Month 12|BMI was calculated by weight divided by height squared and measured as kilogram per square meter (kg/m^2). mBMI was calculated by multiplying BMI by serum albumin levels [gram/liter (g/L)]. mBMI was measured as kg/m^2*g/L. A progressive decline in mBMI indicated worsening of disease severity.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were analyzed for the specific category.||kg/m^2*g/L||Standard Deviation|Mean
761056|NCT00630864|Other Pre-specified|Number of Participants With Clinically Significant Treatment-Emergent Electrocardiogram (ECG) Findings|ECG: investigator assessed test to assess cardiac function. ECG abnormality criteria: any abnormality, arrhythmia, rhythm, conduction, morphology, myocardial infarction, ST segment, T waves and abnormal U waves.|Day 1 up to Month 12|ITT population. The ‘n’ for any post-dose incidence included participants with baseline values that were not abnormal (that is treatment-emergent abnormalities). Abnormalities at early termination were excluded from the analysis.||participants|||Number
761047|NCT00630864|Other Pre-specified|Change From Baseline in Heart Rate Response to Deep Breathing (HRDB) at Month 6 and Month 12|HRDB test was used to evaluate the cardio-vagal response. Participant took a series of 8 deep breaths and average heart rate difference was measured and compared to normative data. The main factor affecting HRDB is age, with older patients showing less heart rate variability. R-R (time between two consecutive R waves in the electrocardiogram) response to deep breathing was reported as the normal deviates (Z-score), the defined position of the result in normal probability distribution with a mean of 0 and standard deviation (std) of 1 and describes how far a score is (in std) from the mean.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were analyzed for the specific category.||Z-score||Standard Deviation|Mean
761048|NCT00630864|Other Pre-specified|Change From Baseline in Nerve Conduction Studies (NCS) at Month 6, Month 12|NCS: quantitative measures of peripheral nerve dysfunction consists of 5 attributes: peroneal nerve (PN) motor distal latency, PN compound muscle action potential, PN motor conduction velocity, tibial nerve distal motor latency, sural nerve sensory nerve action potential. Normal deviates (Z-score) summated into composite score (higher score=worsened nerve fiber function). Z-score is the defined position of the result in normal probability distribution with a mean of 0 and standard deviation (std) of 1 and describes how far a score is (in std) from the mean.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were analyzed for the specific category.||Z-score||Standard Deviation|Mean
761049|NCT00630864|Other Pre-specified|Change From Baseline in Norfolk Quality of Life – Diabetic Neuropathy (QOL-DN) Domain Scores at Month 6, Month 12|Norfolk QOL-DN:35-item participant-rated questionnaire to assess impact of DN on QOL; Item 1-7: scored as 1=symptom present, 0=symptom absent. Item 8-35: scored on 5-point Likert scale:0=no problem, 4=severe problem(except item 32: -2=much better, 0=about same, 2=much worse).Norfolk QOL-DN summarized in 5 domains (score range): physical functioning/large fiber neuropathy(-2 to 58), activities of daily living(ADLs) (0 to 20), symptom(0 to 32), small fiber neuropathy(0 to 16), autonomic neuropathy(0 to 12);higher score=greater impairment, for each. Total score=-2 to 138 (higher score=worse QOL).|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were analyzed for the specific category.||units on a scale||Standard Deviation|Mean
761050|NCT00630864|Other Pre-specified|Change From Baseline in Total Quality of Life (TQOL) Score at Month 6, Month 12|TQOL= sum of all Norfolk Quality of Life–Diabetic Neuropathy (Norfolk QOL-DN) items,a 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on QOL of participants with DN; Item 1 to 7: related to symptoms and presence of symptom was assessed as 1 and absence was assessed as 0. Item 8-35: related to activities of daily living and scored on a 5-point Likert scale, where 0= no problem and 4= severe problem (except item 32, where -2= much better, 0=about the same, 2=much worse). Total TQOL score=-2 to 138;higher score=worse quality of life.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were analyzed for the specific category.||units on a scale||Standard Deviation|Mean
761051|NCT00630864|Other Pre-specified|Percentage of Participants With Response to Treatment as Measured by Neuropathy Impairment Score - Lower Limb (NIS-LL) at Month 6, Month 12|Response to treatment was indicated by either improvement (decrease from baseline) or stabilization (change from baseline of 0 to less than [<] 2) in Neuropathy Impairment Score- Lower Limb (NIS-LL) score, based on mean of 2 scores in 1 week period. NIS-LL: assessed muscle weakness, reflexes, sensation. Each item scored separately for left, right limbs. Components of muscle weakness scored on 0(normal) to 4(paralysis) scale, higher score=greater weakness. Components of reflexes, sensation scored 0=normal, 1=decreased, or 2=absent. Total NIS-LL score range 0-88, higher score=greater impairment.|Month 6, Month 12|Data on NIS-LL was reported in individual participant listings but responder status was not statistically summarized.|||||
761052|NCT00630864|Other Pre-specified|Change From Baseline in the Neuropathy Impairment Score-Lower Limb (NIS-LL) at Month 6, Month 12|NIS-LL: assessed muscle weakness, reflexes and sensation; scored separately for left and right limbs. Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) are scored on 0 to 4 scale, higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae) and sensation (touch pressure, pin-prick, vibration, joint position) were scored 0 = normal, 1= decreased, or 2 = absent. Total possible NIS-LL score range 0-88, higher score=greater impairment.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were analyzed for the specific category.||units on a scale||Standard Deviation|Mean
761053|NCT00630864|Other Pre-specified|Change From Baseline in the Neuropathy Impairment Score (NIS) at Month 6, Month 12|NIS assessed cranial nerves(nerve 3,6; facial, palate and tongue weakness),muscle weakness (respiratory; neck, elbow(E), wrist(W), finger(F), hip, knee(K) flexion; shoulder, thumb abduction; brachioradialis; E, W, hip, K extension; F spread; toe, dorsal and plantar ankle flexors; toe extensors); score: 0-4, higher score=more weakness, reflexes(biceps and triceps brachii; brachioradialis; quadriceps femoris; triceps surae), index F and great toe sensation(touch pressure, pin-prick, vibration, joint position)score:0=normal,1=decreased or 2=absent. Total score=0-244, higher score=more impairment.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were analyzed for the specific category.||units on a scale||Standard Deviation|Mean
761054|NCT00630864|Other Pre-specified|Number of Participants Who Discontinued Due to Clinical or Laboratory Adverse Events||Baseline up to Month 12|ITT population included all participants who received at least 1 dose of study medication.||participants|||Number
761055|NCT00630864|Other Pre-specified|Number of Participants With Clinically Significant Treatment-Emergent Holter Monitoring Findings|Holter monitoring recorded heart rhythm. Holter monitoring abnormality criteria: any abnormality, atrial fibrillation/flutter, atrial tachycardia, non-sustained ventricular tachycardia (VT), sustained VT and sinus pause.|Day 1 up to Month 12|ITT population. The ‘n’ for any post-dose incidence included participants with baseline values that were not abnormal (that is treatment-emergent abnormalities). Abnormalities at early termination were excluded from the analysis.||participants|||Number
761057|NCT00630864|Other Pre-specified|Number of Participants With Clinically Significant Treatment-Emergent Echocardiography (ECHO) Findings|ECHO: investigator assessed test to assess cardiac function. ECHO abnormality criteria: any abnormality, valvular abnormality, pericardial effusion, abnormal regional wall motion, inferior vena cava respiratory variation, posterior (P) left ventricular (LV) wall/septal (S) thickness, right ventricular thickness, ejection fraction, ratio of early (E) diastolic transmitral flow and atrial(A) contraction velocity (E/A), ratio of ‘E’to lateral/septal mitral annular velocity (e') (E/e'prime lateral, E/e'prime septal), E deceleration time (DT), isovolumic relaxation time (IVRT).|Day 1 up to Month 12|ITT population. The ‘n’ for any post-dose incidence included participants with baseline values that were not abnormal (that is treatment-emergent abnormalities). Abnormalities at early termination were excluded from the analysis.||participants|||Number
761058|NCT00630864|Other Pre-specified|Number of Participants With Greater Than or Equal to Grade 3 Treatment-Emergent Adverse Events|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. On the basis of intensity, grade 3 was referred as severe, grade 4 as life-threatening and grade 5 as death.|Baseline up to 30 days after the last dose|ITT population included all participants who received at least 1 dose of study medication.||participants|||Number
761059|NCT00630864|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to 30 days after the last dose|ITT population included all participants who received at least 1 dose of study medication.||participants|||Number
761060|NCT00630864|Secondary|Percentage of Participants With Stabilized Transthyretin (TTR) Tetramer at Month 6 and 12|TTR tetramer was assessed using a validated immunoturbidimetric assay. The FOI is the ratio of the measured TTR tetramer concentration after denaturation to the measured TTR tetramer concentration before denaturation. TTR tetramer stabilization is based on the difference between the on-treatment FOI and the baseline FOI expressed as a percentage of the baseline FOI.|Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure.||percentage of participants||95% Confidence Interval|Number
761061|NCT00630864|Primary|Percentage of Participants With Stabilized Transthyretin (TTR) Tetramer at Week 6|TTR tetramer was assessed using a validated immunoturbidimetric assay. The Fraction of Initial (FOI) is the ratio of the measured TTR tetramer concentration after denaturation to the measured TTR tetramer concentration before denaturation. TTR tetramer stabilization is based on the difference between the on-treatment FOI and the baseline FOI expressed as a percentage of the baseline FOI.|Week 6|Intent-to-Treat (ITT) population included all participants who received at least 1 dose of study medication. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure.||percentage of participants||95% Confidence Interval|Number
761062|NCT00630877|Primary|FAST Responsiveness--maximum Flushing Severity Score|The change in maximum flushing severity scores from study start to Day 43 was compared in subjects classified as responders vs. nonresponders. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. Changes in maximum flushing severity scores were negative if flushing symptoms improved and positive if flushing symptoms worsened.|Study start to Day 43|Subjects in the m-ITT population were classified as responders (improved flushing symptoms) or nonresponders (no change or worsened flushing symptoms) based on changes in flushing symptoms from study start to Day 43.||Units on a scale|||Number
761063|NCT00630877|Primary|FAST Responsiveness--mean Flushing Severity Score|The change in mean flushing severity scores from study start to Day 43 was compared in subjects classified as responders vs. nonresponders. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. Changes in mean flushing severity scores were negative if flushing symptoms improved and positive if flushing symptoms worsened.|Study start to Day 43|Subjects in the m-ITT population were classified as responders (improved flushing symptoms) or nonresponders (no change or worsened flushing symptoms) based on changes in flushing symptoms from study start to Day 43.||Units on a scale|||Number
761064|NCT00630877|Primary|FAST Longitudinal Construct Validity--maximum Flushing Severity Score|The relationship between the change in maximum flushing severity scores from Week 1 to Week 2, and the subject-rated overall treatment effect scale administered at Week 2, was assessed by examining the Spearman rank-order correlation. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. The overall treatment effect was assessed on a scale of 1 (symptoms are worse since study start), 2 (symptoms are about the same since study start), or 3 (symptoms are better since study start).|Week 1 to Week 2|m-ITT population, defined as all randomized subjects who received at least 1 dose of study drug and who had at least 1 entry in the e-diary.||Spearman correlation coefficient|||Number
761065|NCT00630877|Primary|FAST Longitudinal Construct Validity--mean Flushing Severity Score|The relationship between the change in mean flushing severity scores from Week 1 to Week 2, and the subject-rated overall treatment effect scale administered at Week 2, was assessed by examining the Spearman rank-order correlation. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. The overall treatment effect was assessed on a scale of 1 (symptoms are worse since study start), 2 (symptoms are about the same since study start), or 3 (symptoms are better since study start).|Week 1 to Week 2|m-ITT population, defined as all randomized subjects who received at least 1 dose of study drug and who had at least 1 entry in the e-diary.||Spearman correlation coefficient|||Number
761066|NCT00630877|Primary|FAST Cross-sectional Construct Validity--maximum Flushing Severity Score|The relationship between maximum flushing severity and overall flushing troublesomeness was evaluated by examining the Spearman rank-order correlation. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. Overall flushing troublesomeness was assessed using the FAST on a scale of 1 to 10, with 10 being the most troublesome.|Week 1|m-ITT population, defined as all randomized subjects who received at least 1 dose of study drug and who had at least 1 entry in the e-diary.||Spearman correlation coefficient|||Number
761067|NCT00630877|Primary|FAST Cross-sectional Construct Validity--mean Flushing Severity Score|The relationship between mean flushing severity and overall flushing troublesomeness was evaluated by examining the Spearman rank-order correlation. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. Overall flushing troublesomeness was assessed using the FAST on a scale of 1 to 10, with 10 being the most troublesome.|Week 1|m-ITT population, defined as all randomized subjects who received at least 1 dose of study drug and who had at least 1 entry in the e-diary.||Spearman correlation coefficient|||Number
761068|NCT00630877|Primary|FAST Test-retest Reliability--maximum Flushing Severity Score|Test-retest reliability of the maximum flushing severity score was evaluated. The intraclass correlation coefficient comparing flushing severity scores for Week 1 and Week 2 was examined to determine test-retest reliability. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe.|Week 1 to Week 2|Subjects with stable flushing symptoms from Week 1 to Week 2.||Intraclass correlation coefficient|||Number
761069|NCT00630877|Secondary|Maximum Severity of Flushing Events Overall During the Study|The severity of flushing events was assessed as none, mild, moderate, severe, or very severe using the FAST. The maximum severity of flushing events overall during the study was compared among treatment groups.|Week 1 to Week 6|m-ITT population, defined as all randomized subjects who received at least 1 dose of study drug and who had at least 1 entry in the e-diary.||Percentage of subjects|||Number
761070|NCT00630877|Primary|Flushing ASsessment Tool (FAST) Test-retest Reliability--mean Flushing Severity Score|Test-retest reliability of the mean flushing severity score was evaluated. The intraclass correlation coefficient comparing flushing severity scores for Week 1 and Week 2 was examined to determine test-retest reliability. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe.|Week 1 to Week 2|Subjects with stable flushing symptoms from Week 1 to Week 2.||Intraclass correlation coefficient|||Number
761071|NCT00630916|Secondary|Aortic Valve Regurgitation|Measure the level of aortic insufficiency (severity of backflow) in the Mitroflow valve.|12 months|||Percent of participants|||Number
761072|NCT00630916|Primary|Effective Orifice Area|Effective orifice area of the Mitroflow pericardial aortic valve measured via echocardiography to assess physiological area of blood flow through the prosthetic valve for each valve size.|12 months|||cm^2||Standard Deviation|Mean
761073|NCT00630916|Primary|Mean Gradient|Mean pressure across the Mitroflow aortic pericardial valve measured via echocardiography to assess ease of blood flow through the prosthetic valve for each valve size.|12 months|Patients with 12 month hemodynamic evaluations||mmHg||Standard Deviation|Mean
761074|NCT00630916|Primary|Incidence Rate of Adverse Events and Mortality for the Mitroflow Aortic Heart Valve Repair|Hazard rate calculated as the number of adverse events divided by the total follow-up in years. Calculation is based on cumulative events and follow-up occurring >30 days after valve implant.|Late postoperative|Cumulative follow-up in years occurring post 30 days||Percent occurrence per patient-year|Participants|95% Confidence Interval|Mean
761075|NCT00630955|Primary|Baseline-adjusted Craving (YCS)|Craving for alcohol based on Yale Craving Scale, scores ranging from 0-112 mm on a visual analog scale, with higher measurements indicating higher craving. The baseline-adjusted craving is change score from baseline at Day 7.|Day 7|||millimeters||Standard Error|Least Squares Mean
761076|NCT00630955|Secondary|Stimulation and Sedation Responses to Alcohol||Day 7||||||
761077|NCT00630955|Primary|Number of Drinks Consumed on Day 7||Day 7|||standard drinks||Standard Deviation|Mean
761078|NCT00630994|Secondary|Number of Participants With Severe Adverse Events|Severe adverse events were defined as grade 3 or higher, regardless of attribution to study drugs. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3. Adverse events were assessed every cycle during treatment.|Up to 48 weeks|||participants|||Number
761079|NCT00630994|Secondary|Number of Participants With Constitutional Symptoms|Constitutional symptoms including the presence of one or more of the following felt to be attributed to the disease: severe night sweats, fevers, weight loss and bone pain. Symptoms were assessed every cycle during treatment.|Up to 48 weeks|Study terminated prematurely. Analysis not performed.|||||
761080|NCT00630994|Secondary|Time to Disease Progression|"Time to disease progression is defined as the time from registration to progression of disease or death due to any cause.
Progression was defined as any one or more of the following:
1)progressive splenomegaly; 2) leukemic transformation confirmed by a bone marrow blast count of >= 20%; 3) an increase in peripheral blood blast percentage of >=20% that lasts for >= 8 weeks."|up to 3 years|Study terminated prematurely. Analysis not performed.|||||
761081|NCT00630994|Secondary|Overall Survival(OS)|OS was defined as the time from registration to death of any cause.|up to 3 years|Study terminated prematurely. Analysis not performed.|||||
761082|NCT00630994|Primary|Number of Participants Who Achieve a Confirmed Response (Complete Remission (CR), Partial Remission (PR), or Clinical Improvement (CI)), According to International Working Group (IWG) Consensus Criteria.|"Confirmed response: objective status of CR, PR, or CI on 2 consecutive evaluations >=4 weeks apart.
CR:Complete resolution of disease-related symptoms and signs; peripheral blood count remission; normal leukocyte differential; bone marrow histologic remission.
PR: All criteria for CR except the bone marrow histologic remission. CI: one of the following in the absence of both disease progression and CR/PR: minimum (MI) 20-g/L increase (INC) in hemoglobin level; MI 50% reduction in palpable splenomegaly (>=10cm); MI 100% INC in platelet count(>=50000x10^9/L) or ANC (>=0.5x10^9/L)"|Every 4 weeks during treatment (up to 16 weeks)|All participants who met the eligibility criteria that have signed a consent form and went on treatment were evaluable for response. The study was terminated early due to slow enrollment. The primary outcome measure should be assessed with caution.||participants|||Number
761083|NCT00631007|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 With Last Observation Carried Forward.|The change from baseline reflects the Week 24 FPG minus the Week 0 FPG with last observation carried forward.|Weeks 0-24|Randomized subjects who took at least 1 dose of double blind treatment. To be included in analysis of change from baseline to week 24 with last observation carried forward, subjects must have had baseline measurement and at least 1 post baseline measurement.||mg/dL||Standard Deviation|Mean
761130|NCT00631488|Secondary|Change From BL to Week 4 in 2-hr Glucose Area Under The Curve (AUC)||BL, 4 weeks (end of double-blind treatment period)|Full Analysis Set Population||mg.h/dL||Standard Error|Least Squares Mean
761084|NCT00631007|Primary|Change From Baseline in Hemoglobin A1c (HBA1c) at Week 24 With Last Observation Carried Forward|HbA1c is measured as percent. Thus this change from baseline reflects the week 24 HbA1c percent minus the Week 0 HbA1c percent|Weeks 0-24|Randomized subjects who took at least 1 dose of double blind treatment. To be included in analysis of change from baseline to week 24 with last observation carried forward, subjects must have had baseline measurement and at least 1 post baseline measurement.||Percernt||Standard Deviation|Mean
761085|NCT00631020|Secondary|Change in Number of Cigarettes/Day During the Past 7-days Compared to Baseline|Change from baseline self report of number of cigarettes per day compared to the past 7 days at each time point.|Weeks 6, 12, 16 and 24|||cigarettes/day||Standard Deviation|Mean
761086|NCT00631020|Secondary|Change in Tobacco Dependence Compared to Baseline|Tobacco dependence was measured using the Cigarette Dependence Scale (CDS-12). The CDS-12 scale is a 12-item scale that assesses some components of formal diagnostic systems' (e.g., DSM-IV and ICD-10) definitions of dependence with an emphasis on compulsion to smoke, withdrawal, loss of control, time allocation, neglect of other activities, and persistence despite harm. Response choices are on a five-point Likert scale to measure dependence (low =1; high = 5), the total score is the sum of all 12 items with a score range of 12 - 60. The change in scores from baseline at each time point were measured.|Weeks 6, 12, 16 and 24|||units on a scale||Standard Deviation|Mean
761087|NCT00631020|Secondary|Changes in Tobacco Withdrawal Symptoms Compared to Baseline|Tobacco withdrawal symptoms were measured using the Minnesota Nicotine Withdrawal Scale (MNWS). Eight withdrawal symptoms are each rated for their severity on a scale from 0 (not present) to 4 (severe) for the past week and summed to calculate a total score at each time point, with a score range of 0-32. The average change from baseline for all participants at the specified time points were determined.|Weeks 6, 12, 16 and 24|||units on a scale||Standard Deviation|Mean
761088|NCT00631020|Primary|7-day Smoking Abstinence at End of Treatment (Week 6) and at Follow-up Visits (Weeks 12, 16, 24)|The primary index of smoking behavior will be subject’s self-report of smoking using a diary method for the past 7 days prior to the assessment. The subject self-report will be supplemented by: expired CO and by urine cotinine concentrations. Abstinence (yes/no) will be defined as no cigarettes during the past 7 days and an expired CO of <=8 ppm.|week 6, 12, 16 and 24|||participants|||Number
761089|NCT00631020|Primary|Retention in Trial|Retention in trial is defined as completing the 6-week intervention (attended week6, yes/no)|week 6|||participants|||Number
761090|NCT00631020|Primary|Acceptance of Nicotine Replacement Therapy|Participants were offered optional nicotine replacement therapy (NRT). The number of participants that opted for NRT was measured.|week 2|||participants|||Number
761091|NCT00631189|Secondary|To Evaluate Clinical and Laboratory Safety|Serious Adverse Event and Adverse Event reported throughout the study|duration of study|||Adverse Events|||Number
761092|NCT00631189|Secondary|Compare the Numbers of Patients Achieving the LDL-C Goal According to the European Atherosclerosis Society (EAS) Guidelines for the Management of Dyslipidaemic Patients|Not done. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data.|||||||
761093|NCT00631189|Secondary|Compare the Numbers of Patients Achieving the LDL-C Goal According to the National Cholesterol Education Program Adult Treatment Panel III (NCEP) ATP III) Guidelines for the Management of Dyslipidaemic Patients|To Compare numbers of patients achieving the LDL-C goal according to the National Cholesterol Education Program Adult Treatment Panel III (NCEP). As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data. The percentage of patients achieving the NCEP-ATP III LDL-C goal. ATP III is categorized into 3 risk categories:(1) established CHD and CHD risk equivalents(2) multiple risk factors(3) zero to one (0–1) risk factor|from baseline and after 8 weeks of treatment|||Participants|||Number
761094|NCT00631189|Secondary|Compare the Percentage of Variation of Phospholipase A2 (PLA2)|To Compare the percentage of variation of phospholipase A2 (PLA2) taking baseline value as a reference. As the recruitment target was not reached at the date initially planned, and view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data|from baseline and after 8 weeks of treatment|||percent of variation of phospholipase A2||Standard Deviation|Mean
761095|NCT00631189|Secondary|Compare the Percentage of Variation of C-reactive Protein (CRP)|To compare the percentage of variation of C-reactive protein (CRP) taking baseline values as reference. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data|baseline and after 8 weeks of treatment|||percent of variation of C-reactive prot.||Standard Deviation|Mean
761096|NCT00631189|Secondary|Compare the Percentage of Variation From Baseline Apolipoprotein B/Apolipoprotein A1 Ratio and After 8 Weeks of Treatment|To Compare the percentage of variation from baseline Apolipoprotein B/Apolipoprotein A1 ratio and after 8 weeks of treatment. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data|baseline and after 8 weeks of treatment|||percent. Apolipoprotein B/A1 decrease||Standard Deviation|Mean
761097|NCT00631189|Secondary|Compare the Percentage of Variation From Baseline Triglycerides Values and After 8 Weeks|To compare the percentage of variation from baseline triglycerides values and after 8 weeks. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data|Baseline and after 8 weeks of treatment|||percentage of triglycerides decrease||Standard Deviation|Mean
761098|NCT00631189|Secondary|Compare the Percentage of HDL-C (High Density Lipoprotein Cholesterol) Variation From Baseline and After 8 Weeks of Treatment|Compare the percentage of HDL-C (High Density Lipoprotein Cholesterol) variation taking baseline value as a reference and after 8 weeks of treatment. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data|After 8 weeks of treatment|||percentage of HDL-C increase||Standard Deviation|Mean
761099|NCT00631189|Secondary|Compare the Percentage of Total Cholesterol Variation From Baseline and After 8 Weeks of Treatment|To compare the percentage of total cholesterol variation taking baseline value as a reference. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data|from baseline and after 8 weeks of treatment|||percentage of total cholesterol decrease||Standard Deviation|Mean
761100|NCT00631189|Secondary|To Compare the Percentage of Patients Reaching the LDL-C Goal, in Relation to the Number of Risk Factors, According to the French Agency for the Safety of Health Products (AFSSAPS) 2005 Guidelines for the Management of Dyslipidaemic Patients|Not done. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data|Not done||||||
761101|NCT00631189|Secondary|To Compare the Percentage of Patients Reaching the Overall LDL-C Goal According to the French Agency for the Safety of Health Products (AFSSAPS) 2005 Guidelines for the Management of Dyslipidaemic Patients|Not done. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data|Not done||||||
761102|NCT00631189|Primary|Change in Low Density Lipoprotein Cholesterol (LDL-C) Level After 8 Weeks|To compare the percentages of LDL-C level variation. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data|Change from baseline and after 8 weeks of treatment|92 patients completed the study in the Pravastatin group, nevertheless, primary and secondary outcome measures are described on 91 patients in the Pravastatin arm due to one missing data in this group||percentage of LDL-C decrease||Standard Deviation|Mean
761103|NCT00631358|Secondary|Correlation Between Biomarker Expression and the Schirmer Test|Correlation factor: TNFmRNA vs. Schirmer|Baseline to 2 weeks|||Correlation Factor|||Number
761104|NCT00631358|Secondary|Correlation Between Biomarker Expression and NaFl (Sodium Fluorescein) Staining|"Correlation factor:
TNFmRNA vs. NaFl staining"|Baseline to 2 weeks|No data available for the no treatment group.||Correlation factor|||Number
761105|NCT00631358|Secondary|Correlation Between Biomarker Expression and Tear Film Break up Time|"Correlation factor:
TNFmRNA vs. TFBUT (Tear Film Break-up Time)"|Baseline to 2 weeks|||Correlation factor|||Number
761106|NCT00631358|Secondary|Correlation Between Biomarker Expression and Ocular Symptoms|Correlation factor: tumor necrosis factor (TNF) messenger RNA (mRNA) vs. OSDI (Ocular Surface Disease Index).|Baseline to 2 weeks|||Correlation factor|||Number
761107|NCT00631358|Primary|Change in Levels of Biomarkers After Dosing With Maxidex|Biomarkers are an indicatior of inflammation. In this study, the level of biomarkers before and after anti-inflammatory treatment (Maxidex) is measured for the treatment group. In the control group, the biomarker level is measured at baseline and 2 weeks later. ddCt (Delta-Delta-Ct) is the number of polymerase chain reaction (PCR) cycles required to generate a quantifiable number.|Baseline to 2 weeks|||ddCt (Delta-Delta-Ct)||Standard Deviation|Mean
761108|NCT00631371|Secondary|Overall Survival (OS)|OS was defined as the time from randomization to death due to any cause, censored at the last date known alive. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Baseline until death due to any cause, assessed every 8 weeks (up to cut-off date: 19 April 2012)|ITT population included all participants who were randomized to the study.||months||95% Confidence Interval|Median
761109|NCT00631371|Secondary|Percentage of Participants With Objective Response (Complete Response/Partial Response): Independent-Assessment|Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30% decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.|Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012)|ITT population included all participants who were randomized to the study.||percentage of participants||95% Confidence Interval|Number
761110|NCT00631371|Secondary|Progression-Free Survival (PFS): Investigator-Assessment|PFS was defined as the interval from the date of randomization until the earlier date of progression or death. Progression was assessed by investigator imaging reviewers using RECIST criteria which is 20% increase in sum of longest diameter of target lesions from nadir (the lowest blood counts); measurable increase in non-target lesion; appearance of new lesions.|Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012)|ITT population included all participants who were randomized to the study.||months||95% Confidence Interval|Median
761111|NCT00631371|Primary|Progression-Free Survival (PFS): Independent-Assessment|PFS was defined as the interval from the date of randomization until the earlier date of progression or death. Progression was assessed by independent imaging reviewers using Response Evaluation Criteria in Solid Tumors (RECIST) criteria which is 20% increase in sum of longest diameter of target lesions from nadir (the lowest blood counts); measurable increase in non-target lesion; appearance of new lesions.|Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012)|Intent-to-treat (ITT) population included all participants who were randomized to the study.||months||95% Confidence Interval|Median
761112|NCT00631410|Secondary|Sunitinib Relative Dose Intensity in the Treatment Arm B|Relative dose intensity is defined as percentage of total dose administered over total dose assigned through assessment period. Period 1: Cycle 1 to 2; Period 2: Cycle 3 to 4, Period”n”: Cycle (n-1)*2+1 to n*2.|Up to 384 days (the last subject study discontinuation in the Treatment Arm B)|All subjects who received at least 1 dose of the study drug. n = number of subjects assessed for relative dose intensity in the given period.||percent of total planned dose||Standard Deviation|Mean
761131|NCT00631488|Secondary|Change From BL to Week 4 in Fasting Plasma Glucose (FPG)||BL, 4 weeks (end of double-blind treatment period)|Full Analysis Set Population||mg/dL||Standard Error|Least Squares Mean
761113|NCT00631410|Secondary|Sunitinib Relative Dose Intensity in the Treatment Arm A|Relative dose intensity is defined as percentage of total dose administered over total dose assigned through assessment period. Period 1: Cycle 1 to 3; Period 2: Cycle 4 to 6; Period”n”: Cycle (n-1)*3+1 to n*3.|Up to 733 days (the last subject study discontinuation in the Treatment Arm A)|All subjects who received at least 1 dose of the study drug. n = number of subjects assessed for relative dose intensity in the given period.||percent of total planned dose||Standard Deviation|Mean
761114|NCT00631410|Secondary|Progression-Free Survival (PFS)|Progression-free survival is defined as the time from date of enrolment to date of first documentation of progression based on investigator's assessment or death due to any cause.|Up to 733 days (the last subject study discontinuation)|Summary statistics were not calculated due to a small number of subjects.||days||Full Range|Median
761115|NCT00631410|Secondary|Duration of Response (DR)|Duration of response is defined as the duration from the date of first documentation of complete response (CR) or partial response (PR) to date of first documentation of objective progression based on the investigator's assessment.|Up to 733 days (the last subject study discontinuation)|Summary statistics were not calculated due to a small number of subjects.||days||Full Range|Median
761116|NCT00631410|Secondary|Best Overall Response Based on Response Evaluation Criteria in Solid Tumors (RECIST)|Complete response (CR): 2 or more sequential occasions of documented objective disappearance of all target lesions at a minimum of 4 weeks apart; partial response (PR): 2 or more occasions of >=30% decrease in the sum of the longest diameter (LD) of the target lesions from baseline at a minimum of 4 weeks apart; stable disease (SD): at least 1 objective status of stable/no response at least 6 weeks after enrollment; progressive disease (PD): Objective status of progression within 12 weeks of enrollment, not qualifying as CR, PR or Stable; Indeterminate: no other response category applies.|Up to the last subject completed Cycle 24 or individual study discontinuation|All enrolled subjects who 1) had a diagnosis of locally-advanced or metastatic adenocarcinoma of the colon or rectum with measurable disease at baseline; 2) had received at least one dose of the investigational product; and 3) with efficacy data available after administration of the investigational product.||participants|||Number
761117|NCT00631410|Secondary|Plasma Concentration of the Total Drug (Sunitinib Plus SU012662)|Concentrations after administration of sunitinib alone (Day 14 of Cycle 1) and those after administration of sunitinib in combination with mFOLFOX6 (Day 1 of Cycle 2) were evaluated.|Cycle 1 Day 14 and Cycle 2 Day 1|Pharmacokinetic analysis population consisted of subjects with at least 1 plasma drug concentration measurement in the Treatment Arm B.||nanogram per milliliter||Full Range|Median
761118|NCT00631410|Secondary|Plasma Concentration of Sunitinib Active Metabolite (SU012662)|Concentrations after administration of sunitinib alone (Day 14 of Cycle 1) and those after administration of sunitinib in combination with mFOLFOX6 (Day 1 of Cycle 2) were evaluated.|Cycle 1 Day 14 and Cycle 2 Day 1|Pharmacokinetic analysis population consisted of subjects with at least 1 plasma drug concentration measurement in the Treatment Arm B.||nanogram per milliliter||Full Range|Median
761119|NCT00631410|Secondary|Plasma Concentration of Sunitinib|Concentrations after administration of sunitinib alone (Day 14 of Cycle 1) and those after administration of sunitinib in combination with mFOLFOX6 (Day 1 of Cycle 2) were evaluated.|Cycle 1 Day 14 and Cycle 2 Day 1|Pharmacokinetic analysis population consisted of subjects with at least 1 plasma drug concentration measurement in the Treatment Arm B.||nanogram per milliliter||Full Range|Median
761120|NCT00631410|Primary|Number of Participants With Adverse Events|Number of participants with any adverse events, adverse events graded as Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE) Grade 3 or higher , serious adverse events, adverse events resulted in discontinuation, treatment interruption, or dose reduction.|Up to 733 days (the last subject study discontinuation)|All subjects who received at least 1 dose of the study drug.||participants|||Number
761121|NCT00631449|Secondary|Change in Percentage of Activated CD8+ T Cells (CD8+ T Cells That Co-express CD38 and HLA-DR) Will be Assessed as a Secondary Outcome.||Week 24||||||
761122|NCT00631449|Primary|We Will Use as Our Primary Endpoint the Proportion of Subjects in Each Group (Study Drug vs. Placebo) With Undetectable Plasma HIV-1 RNA, as Measured by an Ultra-sensitive Assay With a Limit of Detection of 1 Copy/mL at Week 12.||Week 12|||participants|||Number
761123|NCT00631475|Secondary|Occurrence of Liver Function Test (LFT: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)) Abnormality.|Number of participants with an increase in ALT and/or AST to > 3 times upper limit of normal during the study.|up to 21 months, plus 24 hours after the end of study treatment|Study population||participants|||Number
761124|NCT00631475|Secondary|Treatment-emergent Serious Adverse Events (SAE)|Number of participants with at least one SAE during the study.|up to 21 months plus 28 days after the end of study drug|Study population||participants|||Number
761125|NCT00631475|Secondary|Adverse Events (AE) Leading to Discontinuation of Study Drug.|Number of participants with at least one AE that led to permanent discontinuation of study treatment.|Start to end of study, up to 21 months|Study population||participants|||Number
761126|NCT00631475|Secondary|Number of Patients Exposed to Bosentan Over Time|Numbers of participants exposed to bosentan treatment over time|Start to end of study, up to 21 months|For two patients, the exact treatment stop date was missing and the duration could not be calculated, but these patients received at least 345 and 127 days of OL treatment, respectively.||Participants|||Number
761127|NCT00631475|Primary|Extent of Exposure to Bosentan in Patients With Idiopathic Pulmonary Fibrosis (IPF)|Mean extent of exposure to bosentan treatment in months|Start of study to end of study, up to 21 months|For two patients, the exact treatment stop date was missing and the duration could not be calculated, but these patients received at least 345 and 127 days of open label (OL) treatment.||months||Standard Deviation|Mean
761128|NCT00631488|Secondary|Change From BL to Week 4 in the 2-Hour Active GLP-1 Total AUC|GLP-1 is cleaved from proglucagon to form the active peptide GLP-1. The active form promotes suppression of glucagon secretion. The total AUC of Active GLP-1 levels was calculated from blood sample data measured after the morning meal.|BL, 4 weeks (end of double-blind treatment period)|Full Analysis Set Population||pmole*h/L||Standard Error|Least Squares Mean
761129|NCT00631488|Secondary|Change From BL to Week 4 in the 2-Hour Total GLP-1 Total AUC|Glucagon-Like Peptide-1 (GLP-1) is an incretin hormone that acts as a potent insulin secretegogue in response to nutrient ingestion and stimulates glucose disposition. The total AUC of Total GLP-1 levels was calculated from blood sample data measured after the morning meal.|BL, 4 weeks (end of double-blind treatment period)|Full Analysis Set Population||pmol*h/L||Standard Error|Least Squares Mean
761136|NCT00631540|Secondary|Number of Participants With 9-month Major Adverse Events|Clinical Events Committee Adjudicated Death, Clinical Events Committee Adjudicated Q-wave MI, Clinically-driven Target Lesion Revascularization, Clinical Events Committee Adjudicated Significant Embolic Events.|9 Months|3 participants withdrew, 4 died, and 1 was lost to follow-up prior to 300 days.||Participants|||Number
761137|NCT00631540|Secondary|Number of Participants With 30-day Major Adverse Events|Clinical Events Committee Adjudicated Death, Clinical Events Committee Adjudicated Q-wave MI, Clinically-driven Target Lesion Revascularization, Clinical Events Committee Adjudicated Significant Embolic Events.|30 Days|1 participant withdrew and 1 participant was lost to follow-up prior to 30 days.||Participants|||Number
761138|NCT00631540|Primary|Primary Patency of the Treated Renal Artery|Based on ultrasound images assessed by core lab.|9 Months|||Lesions|Participants||Number
761139|NCT00631657|Other Pre-specified|Change From Baseline in Investigator Global Rating (IGR) - 7-Day Discontinuation Period|The IGR is a clinician-rated 7-point scale used to assess the severity of illness. Severity is rated on a scale from 1=Normal to 7=Extremely severe. Baseline was defined as the last non-missing value obtained during the Placebo Run-in Period. IGR assessments were done at Baseline of the 6-Month Treatment Period and and at the end of the 7-day Discontinuation Period to assess the effects of discontinuing treatment.|Baseline and End of 7-day Discontinuation Period|The ITT population consisted of all participants who received at least one dose of study drug and had a baseline and a 7-Day Discontinuation Period IGR efficacy assessment.||score on a scale||Standard Deviation|Mean
761140|NCT00631657|Other Pre-specified|Change From Baseline in Investigator Global Rating (IGR) - 6-Month Treatment Period|The IGR is a clinician-rated 7-point scale used to assess the severity of illness. Severity is rated on a scale from 1=Normal to 7=Extremely severe. Baseline was defined as the last non-missing value obtained during the Placebo Run-in Period. IGR assessments were done at Baseline of the 6-Month Treatment Period and and at the end of the 6-Month Treatment Period to assess the effects of treatment.|Baseline and Week 26|The ITT population consisted of all participants who received at least one dose of study drug and had a baseline and a Week 26 IGR efficacy assessment.||score on a scale||Standard Deviation|Mean
761141|NCT00631657|Other Pre-specified|Change From Baseline in Two Aggregate Measures of Short Form 36 (SF-36) Health Survey Score - 6-Month Treatment Period|SF-36 is a participant-rated questionnaire that consists of 8 scaled scores: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each of the 8 questions carries equal weight. The SF-36 can be divided into 2 aggregate summary measures: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The scores can range from 0 to 100, with a lower score indicating more disability. Baseline was defined as the SF-36 score assessed at randomization.|Baseline and Week 26|The ITT population consisted of all participants who received at least one dose of study drug and had a baseline and a Week 26 SF-36 efficacy assessment.||score on a scale||Standard Deviation|Mean
761142|NCT00631657|Other Pre-specified|Change From Baseline in Satisfaction With Sleep Duration - 6-Month Treatment Period|"Satifaction with Sleep Duration was assessed using a Visual Analog Scale (VAS) in response to the sleep diary question 8 How satisfied are you about your sleep duration of last night?, as reported by participants using a LogPad. Responses could range from 0=Very unsatisfied to 100=Fully satisfied, with a higher score indicating great satisfaction with sleep duration. Baseline was defined as the mean Satisfaction with Sleep Duration score from the Placebo Run-in Period. Change from Baseline was calculated as the mean of combined data from Weeks 14 through 26, using an LOCF approach."|Baseline and the Mean of Weeks 14-26|The ITT population consisted of all participants who received at least one dose of study drug and had a baseline and at least one postbaseline Satisfaction with Sleep Duration efficacy assessment.||score on a scale||Standard Deviation|Mean
761143|NCT00631657|Other Pre-specified|Change From Baseline in Sleep Quality - 6-Month Treatment Period|"Sleep Quality was assessed using a Visual Analog Scale (VAS) in response to the sleep diary question 7 Rate the quality of your sleep last night, as reported by participants using a LogPad. Responses could range from 0=Very poor to 100=Excellent, with a higher score indicating greater sleep quality. Baseline was defined as the mean Sleep Quality score from the Placebo Run-in Period. Change from Baseline was calculated as the mean of combined data from Weeks 14 through 26, using an LOCF approach."|Baseline and the Mean of Weeks 14-26|The ITT population consisted of all participants who received at least one dose of study drug and had a baseline and at least one postbaseline Sleep Quality efficacy assessment.||score on a scale||Standard Deviation|Mean
761144|NCT00631657|Other Pre-specified|Change From Baseline in Number of Awakenings (NAW) - 6-Month Treatment Period|"NAW was defined as the number of times recorded for sleep diary question 4a How many times did you wake up during the night?, as reported by participants using a LogPad. Baseline was defined as the mean NAW from the Placebo Run-in Period. Change from Baseline was calculated as the mean of combined data from Weeks 14 through 26, using an LOCF approach."|Baseline and the Mean of Weeks 14-26|The ITT population consisted of all participants who received at least one dose of study drug and had a baseline and at least one postbaseline NAW efficacy assessment.||number of awakenings||Standard Deviation|Mean
761145|NCT00631657|Secondary|Change From Baseline in Wake Time After Sleep Onset (WASO) - 6-Month Treatment Period|"WASO was defined as the time recorded for sleep diary question 5 How much time were you awake, after falling asleep initially?, as reported by participants using a LogPad. Baseline was defined as the mean WASO from the Placebo Run-in Period. Change from Baseline was calculated as the mean of combined data from Weeks 14 through 26, using an LOCF approach."|Baseline and the Mean of Weeks 14-26|The ITT population consisted of all participants who received at least one dose of study drug and had a baseline and at least one postbaseline WASO efficacy assessment.||minutes||Standard Deviation|Mean
761146|NCT00631657|Secondary|Change From Baseline in Sleep Latency (SL) - 6-Month Treatment Period|"SL was defined as the time recorded for sleep diary question 3 How long did it take you to fall asllep?, as reported by participants using a LogPad. Baseline was defined as the mean SL from the Placebo Run-in Period. Change from Baseline was calculated as the mean of combined data from Weeks 14 through 26, using an LOCF approach."|Baseline and the Mean of Weeks 14-26|The ITT population consisted of all participants who received at least one dose of study drug and had a baseline and at least one postbaseline SL efficacy assessment.||minutes||Standard Deviation|Mean
761147|NCT00631657|Secondary|Number of Participants Who Discontinued Study Drug Due to an AE|An AE is defined as any unfavorable and unintended change in the structure, function or chemistry of the body whether or not considered related to study drug. The number of participants who discontinued study drug due to an AE is combined for the 6-Month Treatment Period and the 7-Day Discontinuation Period.|Up to 27 weeks|The AST population consisted of all participants who received at least one dose of any study drug.||participants|||Number
761148|NCT00631657|Secondary|Number of Participants Who Experienced Adverse Events (AEs)|An AE is defined as any unfavorable and unintended change in the structure, function or chemistry of the body whether or not considered related to study drug. The number of participants who experienced AEs is combined for the 6-Month Treatment Period and the 7-Day Discontinuation Period.|Up to 31 weeks|The All-Subjects-Treated (AST) population consisted of all participants who received at least one dose of any study drug.||participants|||Number
761149|NCT00631657|Primary|Change From Baseline in Total Sleep Time (TST) - 6-Month Treatment Period|"TST was defined as the time recorded for sleep diary question 6 How much time did you actually spend sleeping? as reported by participants using a LogPad (hand-held electronic data capture device). Baseline was defined as the mean TST from the Placebo Run-in Period. Change from Baseline was calculated as the mean of combined data from Weeks 14 through 26, using a last observation carried forward (LOCF) approach."|Baseline and the Mean of Weeks 14-26|The Intent-To-Treat (ITT) population consisted of all participants who received at least one dose of study drug and had a baseline and at least one postbaseline TST efficacy assessment.||minutes||Standard Deviation|Mean
761150|NCT00631670|Secondary|Overall One Year Survival|Number of patients alive at one year after treatment|One year|||participants|||Number
761151|NCT00631670|Secondary|Pain Relief|Number of patients who reported pain at baseline and reported experienced relief after treatment. Pain was defined on a 10 point scale with 0 being no pain and 10 being worst pain imaginable. Pain relief is defined as reporting a lower level of pain than that reported at baseline.|12 weeks|Patients who reported pain at baseline||participants|||Number
761152|NCT00631670|Secondary|Neurologic Function|Number of patients with a change in neurological function of those who presented with a neurologic deficit from tumor compression. The McCormack score was noted for each patient and the interval change was determined informally as no neurological deficit, better, worse, or unchanged as noted below.|2 years|6 patients presented with tumor-related deficits before treatment.||participants|||Number
761153|NCT00631670|Secondary|Local Control|Number of tumor sites with no evidence of progression of tumor at the site of radiosurgery|1 year|||tumors|Participants||Number
761154|NCT00631670|Primary|Toxicity|"Toxicities were graded using the RTOG-EORTC (Radiation Therapy Oncology Group-European Organization for Research and Treatment of Cancer) system and a descriptive system with which we coded any complication as mild, moderate, or severe based on our informal assessment of the complication's effect on overall quality of life. We assessed toxicity as acute meaning during treatment and late meaning several months after treatment ended."|2 yrs|||participants|||Number
761155|NCT00631696|Secondary|Change From Baseline in Sperm Motility to Week 12|Mean sperm motility (percent motility representing grade a+b) was average of 2 samples collected at that visit. Normal value is ≥50% motility measured within 60 minutes of collection; higher values=greater percentage of sperm with motility. Week 12 was average of last 2 values within window of 2 to 133 days from Study Day 1 and at least 1 of the 2 values was non-missing. If there was only 1 assessment date within the stated window, then Week 12 was the value of that single assessment. If all the values within the window were missing, then the records were not to be used for Week 12 analysis.|Baseline, Week 12 (last observation in the Week 12 window)|MITT; N=number of participants with analyzable data at observation.||percent motility||Standard Deviation|Mean
761156|NCT00631696|Secondary|Change From Baseline in Sperm Motility to Week 26|Mean sperm motility (percent motility representing grade a+b) was the average of 2 samples collected at that visit. Normal value is ≥50% motility measured within 60 minutes of collection; higher values=greater percentage of sperm with motility. Week 26 was average of the last 2 values within window of 134 to 252 days from Study Day 1 and at least 1 of the 2 values was non-missing. If only 1 assessment date within the stated window, Week 26 was the value of that single assessment. If all values within window were missing, the records were not to be used for Week 26 analysis.|Baseline, Week 26 (last observation in the Week 26 window)|MITT; N=number of participants with analyzable data at observation.||percent motility||Standard Deviation|Mean
761157|NCT00631696|Secondary|Change From Baseline in Sperm Motility to End of Study (EOS)|Mean sperm motility (percent motility representing grade a+b [a=sperm with progressive, straight-line motility; b=non-linear motility]) was average of 2 samples collected at that visit. Normal value is ≥50% motility measured within 60 minutes of collection; higher values=greater percentage of sperm with motility. End of study was the end of the washout period (Week 26) following 12 weeks of double-blind treatment. If the semen parameter was not assessed at Week 26, then the last assessment on or after Week 12 (end of treatment) was used instead.|Baseline, End of Study (last observation at Week 26 or last assessment on or after Week 12 if no data at Week 26)|MITT; N=number of participants with analyzable data at observation; LOCF.||percent motility||Standard Deviation|Mean
761158|NCT00631696|Secondary|Change From Baseline in Testosterone to Week 12|Week 12 was the last non-missing value within 2 to 133 days from Study Day 1. If there were multiple observations between the stated study days (all non-missing or a combination of missing and non-missing), then the latest non-missing value was selected for analysis. If all the values within the stated window were missing, then the records were not to be used for Week 12 analysis.|Baseline, Week 12 (last observation in the Week 12 window)|MITT; N=number of participants with analyzable data at observation.||ng/dL||Standard Deviation|Mean
761159|NCT00631696|Secondary|Change From Baseline in Testosterone to Week 26|Week 26 was the non-missing value within 134 to 252 days from Study Day 1. If there were multiple observations between the stated study days (all non-missing or a combination of missing and non-missing), then the latest non-missing value was selected for analysis. If all the values within the stated window were missing, then the records were not to be used for Week 26 analysis.|Baseline, Week 26 (last observation in the Week 26 window)|MITT; N=number of participants with analyzable data at observation.||ng/dL||Standard Deviation|Mean
761294|NCT00638963|Secondary|Number of Days With Distant Disease-free Survival (DDFS)|"DDFS was defined as the time interval from randomization to only distant metastases (for example, bone, visceral organ, brain).
The analysis could not be performed due to low enrollment."|24, 38, and 52 weeks||||||
761160|NCT00631696|Secondary|Change From Baseline in Testosterone to End of Study (EOS)|End of study was the end of the washout period (Week 26) following 12 weeks of double-blind treatment. If the semen parameter was not assessed at Week 26, then the last assessment on or after Week 12 (end of treatment) was used instead.|Baseline, End of Study (last observation at Week 26 or last assessment on or after Week 12 if no data at Week 26)|MITT; N=number of participants with analyzable data at observation; LOCF.||nanograms per deciliter (ng/dL)||Standard Deviation|Mean
761161|NCT00631696|Secondary|Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 12|FSH minimum normal range 1.4 IU/L to maximum normal range 18.1 IU/L. Week 12 was the last non-missing value within 2 to 133 days from Study Day 1. If there were multiple observations between the stated study days (all non-missing or a combination of missing and non-missing), then the latest non-missing value was selected for analysis. If all the values within the stated window were missing, then the records were not to be used for Week 12 analysis.|Baseline, Week 12 (last observation in the Week 12 window)|MITT; N=number of participants with analyzable data at observation.||IU/L||Standard Deviation|Mean
761162|NCT00631696|Secondary|Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 26|FSH minimum normal range 1.4 IU/L to maximum normal range 18.1 IU/L. Week 26 was the non-missing value within 134 to 252 days from Study Day 1. If there were multiple observations between the stated study days (all non-missing or a combination of missing and non-missing), then the latest non-missing value was selected for analysis. If all the values within the stated window were missing, then the records were not to be used for Week 26 analysis.|Baseline, Week 26 (last observation in the Week 26 window)|MITT population; N=number of participants (observed cases) with analyzable data at observation.||IU/L||Standard Deviation|Mean
761163|NCT00631696|Secondary|Change From Baseline in Follicle Stimulating Hormone (FSH) to End of Study (EOS)|FSH minimum normal range 1.4 International units per liter (IU/L) to maximum normal range 18.1 IU/L. End of study was the end of the washout period (Week 26) following 12 weeks of double-blind treatment. If the semen parameter was not assessed at Week 26, then the last assessment on or after Week 12 (end of treatment) was used instead.|Baseline, End of Study (last observation at Week 26 or last assessment on or after Week 12 if no data at Week 26)|Modified intent-to-treat (MITT) population included all randomized participants who received at least 1 dose of study medication (either pregabalin or placebo) and were not discontinued for major violation at the site level. N=number of participants with analyzable data at observation; LOCF.||IU/L||Standard Deviation|Mean
761164|NCT00631696|Primary|Percentage of Participants With a 50 Percent (%) or More Reduction in Sperm Concentration From Baseline (Bsl) to End of Study (EOS)|Baseline is the average of sperm concentrations from semen samples collected on or before Study Day 1. End of study is average of sperm concentrations from semen samples collected at end of washout period (Week 26) following 12 weeks of double-blind treatment. Mean sperm concentration (MSC) of a visit is average of the 2 sperm concentration samples collected at that visit. If sperm concentration was not assessed at Week 26, then the last assessment on or after Week 12 (end of treatment) was used instead. Confidence intervals (CI) based on exact distribution.|Baseline, End of Study (last observation at Week 26 or last assessment on or after Week 12 if no data at Week 26)|Per protocol analysis set: all randomized participants who had ≥8 weeks of study treatment, sperm concentration measurements at or after week 12 window, did not discontinue for site violations, and did not have any major protocol violations. N=number of participants with analyzable data at observation; Last observation carried forward (LOCF).||percentage of participants||95% Confidence Interval|Number
761165|NCT00631748|Secondary|Percentage of Participants Attaining Abstinence for Three Weeks|Abstinence was defined as a negative urine drug screen (UDS) (for cocaine) for three consecutive weeks of the trial measure at either time point Week 6 or Week 12|Abstinence defined as negative UDS for 3 consecutive weeks of the trial|At end of study (12-weeks) 11 participants remained in the quetiapine group and 9 participants remained in the placebo group.||Percentage of Participants|||Number
761166|NCT00631748|Primary|Timeline Followback Interview (TLFB)|The primary outcome measure was the self-report of cocaine use in the past week, as assessed with a Timeline Followback Interview (TLFB). The TLFB is a questionnaire in which the subject is asked to self-report how much cocaine was used and how much money was spent on cocaine every day for the past 1-2 weeks.|Grams of cocaine used at end of study (12-weeks)|At end of study(12-weeks) 11 participants remained in the quetiapine group and 9 participants remained in the placebo group.||grams of cocaine used||Standard Deviation|Mean
761167|NCT00631917|Primary|Summary of the End of Study Colonoscopy Results|During each colonoscopy procedure, random biopsy samples were taken from normal appearing mucosa in both the cecum and rectum in addition to obvious endoscopically atypical areas. The mucosal biopsy samples were evaluated for mucosal hyperplasia, dysplasia, and inflammation. Anything noted as a distinct visual abnormality from cecum to rectum such as ulcers, erythematous mucosa, or polyps, was photographed and biopsied for histopathology evaluation. Colonic lesions were categorized according to location in the colon, size, number, and morphology.|54 weeks|Primary Analysis Set, consisting of all randomized patients that had post-baseline colonoscopy procedure performed.||Percentage of Participants|||Number
761168|NCT00631917|Secondary|Percentage of Participants Achieving the Mean Sitting Blood Pressure Control Target|The mean sitting blood pressure control target is defined as less than 140/90 mmHg (or 130/80 mmHg for diabetic patients)|Weeks 8, 30 and End of Study (54 weeks)|Full analysis set||Percentage of Participants|||Number
761169|NCT00631917|Secondary|Mucosal Hyperplasia Score in Rectal and Cecal Mucosal Biopsy Specimens After One Year of Treatment|Maximum hyperplasia score at end of study across rectal and cecal mucosa biopsy specimens. Score of 0 is no change from baseline, the minimum possible score. Score > 0 is worsening from baseline in which the maximum possible score is 3.|54 weeks|Primary analysis set||participants|||Number
761170|NCT00631917|Secondary|Percentage of Participants With Each of the Individual Components of Colonic Pathology|Assessment of the occurrence of the individual components (hyperplastic polyps, inflammatory polyps, adenomatous polyps or carcinomas) of the composite endpoint (colonic pathology) following one-year of treatment with an aliskiren-based regimen compared to a ramipril-based regimen.|54 weeks|Primary analysis set||Percentage of Participants|||Number
761248|NCT00638235|Secondary|Patient Satisfaction Questionnaire at 12 Months by Question (Q#1)|Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure.|12 months|Overall, what outcome do you feel you have achieved after having this surgery? (% of subjects answering this question)||Percentage of participants|||Number
761171|NCT00631917|Primary|Percentage of Participants With Colonic Pathology|The primary analysis variable was the occurrence of an abnormal colonoscopy finding (defined as hyper-plastic polyps, inflammatory polyps, adenomatous polyps or carcinoma) at or prior to the planned one year visit. The occurrence of colonic pathology was identified during colonoscopy and histopathologic examination of biopsy. The composite endpoint was evaluated after one year of treatment with an aliskiren-based regimen compared to a ramipril-based regimen.|54 weeks|Primary Analysis Set, consisting of all randomized patients that had post-baseline colonoscopy procedure performed.||Percentage of participants|||Number
761172|NCT00631969|Secondary|Pharmacokinetics Measured as Maximum Concentration (Cmax) of Metabolite M-1 (BAY44-5576) in Plasma|Plasma concentrations after single dose administration of 10 mg Vardenafil ODT followed for up to 24 hours post-dose.|Visit 5 after 12 weeks of treatment|Pharmacokinetics were studied in a sub-group of 25 ED patients receiving a single dose of 10 mg Vardenafil ODT on a separate visit. This sub-population comprised 12 patients aged 18-64 years and 13 patients aged 65 years and above.||µg/L||Full Range|Geometric Mean
761173|NCT00631969|Secondary|Pharmacokinetics Measured as Area Under Curve (AUC) of Metabolite M-1 (BAY44-5576) in Plasma|Plasma concentrations after single dose administration of 10 mg Vardenafil ODT followed for up to 24 hours post-dose.|Visit 5 after 12 weeks of treatment|Pharmacokinetics were studied in a sub-group of 25 ED patients receiving a single dose of 10 mg Vardenafil ODT on a separate visit. This sub-population comprised 12 patients aged 18-64 years and 13 patients aged 65 years and above. AUC data were not available in 3 elderly patients.||µg*h/L||Full Range|Geometric Mean
761174|NCT00631969|Secondary|Pharmacokinetics Measured as Maximum Concentration (Cmax) of Vardenafil in Plasma|Plasma concentrations after single dose administration of 10 mg Vardenafil ODT followed for up to 24 hours post-dose.|Visit 5 after 12 weeks of treatment|Pharmacokinetics were studied in a sub-group of 25 ED patients receiving a single dose of 10 mg Vardenafil ODT on a separate visit. This sub-population comprised 12 patients aged 18-64 years and 13 patients aged 65 years and above.||μg/L||Full Range|Geometric Mean
761175|NCT00631969|Secondary|Pharmacokinetics Measured as Area Under Curve (AUC) of Vardenafil in Plasma|Plasma concentrations after single dose administration of 10 mg Vardenafil ODT followed for up to 24 hours post-dose.|Visit 5 after 12 weeks of treatment|Pharmacokinetics (PK) were studied in a sub-group of 25 ED patients receiving a single dose of 10 mg Vardenafil ODT on a separate visit. This sub-population comprised 12 patients aged 18-64 years and 13 patients aged 65 years and above. The PK data of one elderly patient were only evaluable for Cmax but not for AUC.||μg*h/L||Full Range|Geometric Mean
761176|NCT00631969|Secondary|Patient Self Reported Improvement of Erectile Function Under Treatment Using a Categorical Rating Scale|Categorical Rating Scale is a binary rating scale with 2 response options which is 'yes/no'; percentage of participants with positive answers to the Global Assessment Question. Global Assessment Question (GAQ): 'Has the treatment you have been taking over the past for weeks improved your erection?' (yes/no)|up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.||percentage of participants|||Number
761177|NCT00631969|Secondary|Satisfaction With Medication at Week 12 or LOCF|Treatment group difference in points on the Treatment Satisfaction Scale (TSS, 0-100 normalized ordinal scores, higher scores indicate greater levels of 'ease with erection', 'erectile functioning satisfaction', 'pleasure of sexual activity', 'satisfaction with orgasm', 'confidence for completion', and 'satisfaction with medication') domain “Satisfaction with medication” at LOCF expressed as the least square mean difference.|up to 12 weeks|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with LOCF values.||scores on a scale||Standard Deviation|Mean
761178|NCT00631969|Secondary|Change From Baseline in Confidence for Completion at 12 Weeks or LOCF|Treatment group difference in points on the Treatment Satisfaction Scale (TSS, 0-100 normalized ordinal scores, higher scores indicate greater levels of 'ease with erection', 'erectile functioning satisfaction', 'pleasure of sexual activity', 'satisfaction with orgasm', 'confidence for completion', and 'satisfaction with medication') domain “Confidence for completion” from baseline to Week 12 or LOCF expressed as the least square mean difference.|from baseline up to 12 weeks|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.||scores on a scale||Standard Deviation|Mean
761179|NCT00631969|Secondary|Change From Baseline in Satisfaction With Orgasm at 12 Weeks or LOCF|Treatment group difference in points on the Treatment Satisfaction Scale (TSS, 0-100 normalized ordinal scores, higher scores indicate greater levels of 'ease with erection', 'erectile functioning satisfaction', 'pleasure of sexual activity', 'satisfaction with orgasm', 'confidence for completion', and 'satisfaction with medication') domain “Satisfaction with orgasm” from baseline to Week 12 or LOCF expressed as the least square mean difference.|from baseline up to 12 weeks|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.||scores on a scale||Standard Deviation|Mean
761180|NCT00631969|Secondary|Change From Baseline in Pleasure of Sexual Activity at 12 Weeks or LOCF|Treatment group difference in points on the Treatment Satisfaction Scale (TSS, 0-100 normalized ordinal scores, higher scores indicate greater levels of 'ease with erection', 'erectile functioning satisfaction', 'pleasure of sexual activity', 'satisfaction with orgasm', 'confidence for completion', and 'satisfaction with medication') domain “ Pleasure of sexual activity” from baseline to Week 12 or LOCF expressed as the least square mean difference.|from baseline up to 12 weeks|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.||scores on a scale||Standard Deviation|Mean
761181|NCT00631969|Secondary|Change From Baseline in Erectile Function Satisfaction at 12 Weeks or LOCF|Treatment group difference in points on the Treatment Satisfaction Scale (TSS, 0-100 normalized ordinal scores, higher scores indicate greater levels of 'ease with erection', 'erectile functioning satisfaction', 'pleasure of sexual activity', 'satisfaction with orgasm', 'confidence for completion', and 'satisfaction with medication') domain “ Erectile function satisfaction” from baseline to Week 12 or LOCF expressed as the least square mean difference.|from baseline up to 12 weeks|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.||scores on a scale||Standard Deviation|Mean
761295|NCT00638963|Secondary|Number of Days With Disease-free Survival (DFS)|"DFS was defined as the time interval from randomization to any relapse (loco-regional, contra-lateral, and/or distant).
The analysis could not be performed due to low enrollment."|24, 38, and 52 weeks||||||
761182|NCT00631969|Secondary|Change From Baseline in Ease With Erection at 12 Weeks or LOCF|Treatment group difference in points on the Treatment Satisfaction Scale (TSS, 0-100 normalized ordinal scores, higher scores indicate greater levels of 'ease with erection', 'erectile functioning satisfaction', 'pleasure of sexual activity', 'satisfaction with orgasm', 'confidence for completion', and 'satisfaction with medication') domain “Ease with Erection” from baseline to Week 12 or LOCF expressed as the least square mean difference.|from baseline up to 12 weeks|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.||scores on a scale||Standard Deviation|Mean
761183|NCT00631969|Secondary|Number of Sexual Attempts Till First Successful Attempt||up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.||Sexual Attempts||Standard Deviation|Mean
761184|NCT00631969|Secondary|Change in Percentage From Baseline in Ability to Ejaculate at 12 Weeks|SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to have successful ejaculations.|from baseline up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.||percentage of ejaculation successes||Standard Deviation|Mean
761185|NCT00631969|Secondary|Change in Percentage From Baseline in Overall Satisfaction at 12 Weeks|SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to overall satisfactory attempts.|from baseline up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.||percentage of satisfactory attempts||Standard Deviation|Mean
761186|NCT00631969|Secondary|Change in Percentage From Baseline in Satisfaction With the Hardness of Erection at 12 Weeks|SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to get satisfactory hardness of erections.|from baseline up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.||percentage of satisfactory erections||Standard Deviation|Mean
761187|NCT00631969|Secondary|Change in Percentage From Baseline in Ability to Obtain an Erection at 12 Weeks|SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to obtain successful erections.|from baseline up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.||percentage of successful erections||Standard Deviation|Mean
761188|NCT00631969|Secondary|"Percentage of Subjects Achieving Back to Normal Erectile Function"|Responders: percentage of subjects achieving an IIEF-EF score > 25. The primary variable was the treatment group difference from baseline to Week 12 or Last observation carried forward (LOCF) of the least square mean difference in the IIEF-EF domain score (1-30 ordinal points, specifying the severity of erectile dysfunction: <=10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; >25 'no ED').|up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.||percentage of participants|||Number
761189|NCT00631969|Primary|Change From Baseline in Success of Erection Maintenance at 12 Weeks|SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to maintain an erection after penetration.|from baseline up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.||percentage of success in maintenance||Standard Deviation|Mean
761190|NCT00631969|Primary|Change in Percentage From Baseline in Success of Penetration at 12 Weeks|Sexual encounter profile (SEP) items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to penetrate the partner.|from baseline up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.||percentage of successful penetrations||Standard Deviation|Mean
761191|NCT00631969|Primary|Change From Baseline in International Index of Erectile Function (IIEF-EF Sub-Score) at 12 Weeks or LOCF|The primary variable was the treatment group difference from baseline to Week 12 or Last observation carried forward (LOCF) of the least square mean difference in the IIEF-EF domain score (1-30 ordinal points, specifying the severity of erectile dysfunction: <=10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; >25 'no ED').|from baseline up to 12 weeks|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.||scores on a scale||Standard Deviation|Mean
761192|NCT00632021|Secondary|Number of Participants With Unplanned Hospitalizations and Emergency Department Visits|Unplanned hospitalizations and Emergency Department visits|Measured at Day 30|||Participants|||Count of Participants
761193|NCT00632021|Primary|Number of Serious Medication Errors as Determined by Interview and Medical Chart Review|Number of clinically important medication errors per patient|Measured at Day 30|||serious medication errors||Standard Deviation|Mean
761194|NCT00632099|Primary|Cocaine Abstinence Based on Urine Toxicology Results|Percentage of patients cocaine abstinent during last 3 weeks of the study (weeks 7-9)|during last 3 weeks of the trial|||participants|||Number
761195|NCT00632125|Primary|Drug-related Adverse Events Consisting of Epoetin Alfa-induced Immunogenicity and Resulting Clinical Effects|The incidence of relevant drug-related adverse events consisting of Epoetin alfa-induced immunogenicity and resulting blockade in erythroid maturation (e.g. pure red cell aplasia) and lack of efficacy|6 months|Safety population: The safety population consists of all patients that received at least one dose of study drug||percentage of participants||95% Confidence Interval|Number
761196|NCT00632203|Secondary|Tolerability of Maintenance Temozolomide|Tolerability was defined as number of participants with any adverse event leading to study discontinuation and/or study drug discontinuation.|from Cycle 1 Day 1 of Standard First Line Systemic Therapy to the last time of follow-up (up to 6 cycles (168 days) of study treatment)|||participants|||Number
761197|NCT00632203|Secondary|Cancer-related Quality of Life (QoL) as Assessed by The European Organization for Research and Treatment of Cancer (EORTC) QoL Questionnaire C30 Version 3.0 (QLQ-C30), and the EORTC Lung Cancer Module (QLQ-LC13)|The EORTC QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients. Scores range from 0 -100. For functional and global QoL scales, higher scores mean a better level of function. For symptom-oriented scales, a higher score means more severe symptoms and a decrease in QoL. The EORTC QLQ-LC13 is a 13-item questionnaire developed to supplement the EORTC QLQ-C30 in lung cancer patients. It has a score range 0-100 with higher scores representing an increase in symptoms.|from Cycle 1 Day 1 of Standard First Line Systemic Therapy to the last time of follow-up (up to 6 cycles (168 days) of study treatment)|No analysis was performed due to study termination.|||||
761198|NCT00632203|Secondary|Number of Participants With Brain Metastases at First Progression|Brain Metastases were defined as radiological evidence of brain metastases on MRI.|from Cycle 1 Day 1 of Standard First Line Systemic Therapy to the last time of follow-up (up to 6 cycles (168 days) of study treatment)|No analysis was performed due to study termination.|||||
761199|NCT00632203|Secondary|Overall Survival|The overall survival was analyzed using the Kaplan-Meier method.|from Cycle 1 Day 1 of Standard First Line Systemic Therapy to the last time of follow-up|||months||95% Confidence Interval|Median
761200|NCT00632203|Secondary|Time to Progression|"The time to progression (per response evaluation criteria in solid tumors [RECIST]) was analyzed using the Kaplan-Meier method.
Definitions of response per RECIST:
Complete Response (CR): Disappearance of all target lesions.
Partial Response (PR): A decrease of at least 30% in the sum of the longest
diameter of target lesions.
Progressive Disease (PD): An increase of at least 20% in the sum of the longest
diameter of target lesions.
Stable Disease (SD): Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease."|from Cycle 1 Day 1 of Standard First Line Systemic Therapy to progression or up to 6 cycles (168 days) of study treatment|||months||95% Confidence Interval|Median
761201|NCT00632203|Secondary|Time to Radiological Central Nervous System (CNS) Progression|"Defined as CNS progression as measured by MRI.
Time to CNS progression was analyzed using the Kaplan-Meier method."|from Cycle 1 Day 1 of Standard First Line Systemic Therapy to radiological progression or the last known CNS progression-free date|||months||95% Confidence Interval|Median
761202|NCT00632203|Primary|Number of Participants Who Had Brain Metastases|Brain Metastases were defined as radiological evidence of brain metastases on magnetic resonance imaging (MRI).|Up to 12 months (as measured from day 1 of cycle 1 of standard first-line systemic chemotherapy)|Evaluable population, defined as a participant who had at least one post-randomization MRI scan||participants|||Number
761203|NCT00632229|Secondary|Clinical Global Impressions - Severity of Obsessive-Compulsive Symptoms|This assessment measures the overall severity of obsessive-compulsive symptoms. It consists of a single item that is completed by a clinician with scores ranging from 0-6 with higher scores corresponding with more severe obsessive-compulsive symptoms. Thus, higher scores represent a worse outcome.|post-treatment|Includes those subjects who were randomized to their respective condition.||Scores on a scale||Standard Deviation|Mean
761204|NCT00632229|Primary|Yale Brown Obsessive Compulsive Scale|This measure assesses obsessive-compulsive symptom severity across 10 items that are completed during an interview format with the person with OCD. These 10 items are summed to derive a total score, which ranges from 0-40 [Scale range: 0 (Minimum) - 40 (Maximum)] with higher scores corresponding to more severe obsessive-compulsive symptoms.|End of study (8 weeks)|||Scores on a scale||Standard Deviation|Mean
761205|NCT00632281|Secondary|Toxicity ot the Thorax|"Toxicity is defined as adverse events described in the CTCAE (version 3). Acute toxicity refers to adverse events that occurred up until 3 months after treatment and late toxicity as those occurring 3 months or longer after the end of treatment. Below are the Rates of grade 2 acute toxicity, grade 3 acute toxicity, late grade 3 toxicity, and late grade 4 toxicity"|up to 2 years, 9 months|||percentage of participants|||Number
761206|NCT00632281|Primary|Disease Status|2-year local control (Percentage of tumors that did not recur at treated site 2 years after treatment), cause-specific survival (percentage of patients who had not died from disease under study in the 2 years since treatment), overall survival (percent of patients still alive at 2 years after treatment), and freedom from failure (percentage of patients in whom the disease treated had not progressed or recurred in the 2 years since treatment)|2 yrs|44 lesions in 38 patients were treated with IMRT or 3D conformal beams on a prospective trial examining thoracic SBRT. Twenty-two of 32 primary lung cancer patients had biopsy-proven NSCLC (stage IA, 21 patients; stage IB, 11 patients). Six had metastatic disease. Six patients had 2 lesions treated simultaneously.||percentage of participants|||Number
761207|NCT00638183|Primary|Number of Patients With Adverse Drug Reactions (ADRs)|Number of Patients with ADRs. An adverse drug reaction was defined as an adverse event with a relationship to Tiotropium inhalation.|Pre treatment and 52 weeks after the treatment|373 patients were involved in the safety analysis data||Participants|||Number
761208|NCT00638183|Primary|Number of Patients With Adverse Events (AEs)|Number of patients with AEs|Pre treatment and 52 weeks after the treatment|373 patients were involved in the safety analysis data||Participants|||Number
761209|NCT00638183|Secondary|Change in Forced Expiratory Volume (L) in 1 Second at 52 Weeks|Difference between Mean of Pre- and each week's forced expiratory volume in 1 second (FEV1) The FEV1 is the volume (Liters) exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity. FEV1 is by far the most frequently used index for assessing airway obstruction, bronchoconstriction or bronchodilatation|Pre treatment and 52 weeks after the treatment|All patients for which respiratory function testing was conducted at baseline and at 52 weeks||Liters||Standard Deviation|Mean
761210|NCT00638183|Secondary|Effective Rate of Comprehensive Evaluation|"Evaluate from improvement FEV1 (forced expiratory volume in 1 second) and/or Symptoms by Investigator.
Latest time point, at the end of the observation or 1 year after the initiation of treatment, investigator judged and decided comprehensive evaluation.
comprehensive evaluation was classified into 3 category, improve No change+Aggravated and Unassessable by reference to the result of FEV1 and symptoms. The effective rate was derived from rate of Improvement in total number of analyzed patients"|52 weeks|249 patient were evaluated the efficacy||percentage of effective patients|||Number
761211|NCT00638222|Secondary|Plasma F2-isoprostanes||week 1, 8, 11, 18||||||
761212|NCT00638222|Secondary|Plasma NT-pro BNP||week 1, 8, 11, 18||||||
761213|NCT00638222|Secondary|Plasma Cardiac Troponin T||week 1, 8, 11, 18||||||
761218|NCT00638235|Secondary|Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Anterior Compartment at 24M Post Procedure|Analysis includes only subjects with anterior vaginal wall prolapse >= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method (LFCF). Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.|24 months|Analysis includes only subjects with anterior vaginal wall prolapse >= stage II at baseline||Percentage of participants||95% Confidence Interval|Number
761219|NCT00638235|Secondary|Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Anterior Compartment at 6M Post Procedure|Analysis includes only subjects with anterior vaginal wall prolapse >= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method (LFCF). Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.|6 months|Analysis includes only subjects with anterior vaginal wall prolapse >= stage II at baseline||percentage of participants||95% Confidence Interval|Number
761220|NCT00638235|Other Pre-specified|Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Apical Compartment at 24M Post Procedure|Analysis includes only subjects with uterine descent >= stage II at baselineThe POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.|24 months|Analysis includes only subjects with uterine descent >=stage II at baseline||Percentage of participants||95% Confidence Interval|Number
761221|NCT00638235|Other Pre-specified|Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Apical Compartment at 6M Post Procedure|Analysis includes only subjects with uterine descent >= stage II at baselineThe POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.|6 months|Analysis includes only subjects with uterine descent >=stage II at baseline||Percentage of participants||95% Confidence Interval|Number
761222|NCT00638235|Secondary|Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Posterior Compartment at 24M Post Procedure|Analysis includes only subjects with posterior vaginal wall prolapse >= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.|24 months|Analysis includes only subjects with posterior vaginal wall prolapse >= stage II at baseline||percentage of participants||95% Confidence Interval|Number
761223|NCT00638235|Secondary|Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Posterior Compartment at 6M Post Procedure|Analysis includes only subjects with posterior vaginal wall prolapse >= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.|6 months|Analysis includes only subjects with posterior vaginal wall prolapse >= stage II at baseline||percentage of participants||95% Confidence Interval|Number
761224|NCT00638235|Primary|Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Anterior Compartment at One Year Post Procedure|Analysis includes only subjects with anterior vaginal wall prolapse >= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method (LFCF). Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.|12-months|Analysis includes only subjects with anterior vaginal wall prolapse >= stage II at baseline||percentage of participant||95% Confidence Interval|Number
761261|NCT00638365|Primary|The Safety and Tolerability of a Single-dose of KB001.|Safety assessments were conducted after completion of day 28. AEs were followed through completion of day 56.|Day 28|Safety population: all subjects randomized and receiving any study medication.||Number of participants experiencing AEs|||Number
767735|NCT00697593|Primary|Biochemistry - Potassium|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 1 participant missing values||mmol/L||Standard Deviation|Mean
761225|NCT00638235|Primary|Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Apical Compartment at One Year Post Procedure|Analysis includes only subjects with uterine descent >= stage II at baselineThe POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.|12-months|Analysis includes only subjects with uterine descent >=stage II at baseline||percentage of participant||95% Confidence Interval|Number
761226|NCT00638235|Secondary|QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 24M|Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|baseline and 24 months|QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.||Percentage of participants||Standard Deviation|Mean
761227|NCT00638235|Secondary|QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 12M|Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|baseline and 12 months|QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.||Percentage of participants||Standard Deviation|Mean
761228|NCT00638235|Secondary|QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 24M|Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|baseline and 24 months|QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.||Percentage of participants||Standard Deviation|Mean
761229|NCT00638235|Secondary|QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 12M|Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|baseline and 12 months|QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.||Percentage of participants||Standard Deviation|Mean
761230|NCT00638235|Secondary|QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 6M|Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|baseline and 6 months|QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.||Percentage of participants||Standard Deviation|Mean
761231|NCT00638235|Secondary|QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 6M|Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|baseline and 6 months|QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.||Percentage of participants||Standard Deviation|Mean
761232|NCT00638235|Secondary|QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 24M|Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|baseline and 24 months|QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.||Percentage of participants||Standard Deviation|Mean
761233|NCT00638235|Secondary|QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 12M|Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|baseline and 12 months|QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.||Percentage of participants||Standard Deviation|Mean
761234|NCT00638235|Secondary|QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI (Pelvic Floor Distress Inventory) Sub-scale UDI (Urinary Distress Inventory) at 6M|Quality of Life as measure by PFDI subscale UDI. UDI scale ranges from 0-100 with 100 representing the most urinary distress. Changes in UDI scores between follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|baseline and 6 months|Changes in QoL scores between follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.||scores on a scale||Standard Deviation|Mean
761290|NCT00638963|Secondary|Number of Participants Who Had at Least One Dose Reduction During Treatment|This outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed.|Baseline to 24 Weeks|||Participants|||Number
761235|NCT00638235|Secondary|QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 24M|Quality of Life as measure by Pelvic Floor Impact Questionnaire - Short Form 7(PFIQ-7) QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|baseline and 24 months|QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.||Percentage of participants||Standard Deviation|Mean
761236|NCT00638235|Secondary|QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 12M|Quality of Life as measure by Pelvic Floor Impact Questionnaire - Short Form 7(PFIQ-7) QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|baseline and 12 months|QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.||Percentage of participants||Standard Deviation|Mean
761237|NCT00638235|Secondary|QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 6M|Quality of Life as measure by Pelvic Floor Impact Questionnaire - Short Form 7(PFIQ-7) QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. .|baseline and 6 months|QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.||Percentage of participants||Standard Deviation|Mean
761238|NCT00638235|Secondary|QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12|Quality of Life as measure by Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|baseline and 24 months|QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.||Percentage of participants||Standard Deviation|Mean
761239|NCT00638235|Secondary|QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12|Quality of Life as measure by Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|12 months|QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.||Percentage of participants||Standard Deviation|Mean
761240|NCT00638235|Secondary|Wong-Baker Faces Pain Scale at 3 Months Post Procedure|Pain - defined as the level of pain or discomfort associated with the pelvic area measured by the Wong-Baker Faces Pain Scale at baseline and 3 months post procedure|baseline and 3 months|Changes in pain scores between follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.||Percentage of participants||Standard Deviation|Mean
761241|NCT00638235|Secondary|Patient Satisfaction Questionnaire at 24 Months by Question (Q#3)|"Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 24 months post-procedure.
Note:
Phase VI ended after 12M follow up visit because the next generation of the study device was already under clinical evaluation in Phase VII
Phase II ended early before all subjects reached their 24M visit because the study device is no longer marketed due to release of models with enhancements to the design"|24 months|Would you recommend this procedure to a friend suffering from prolapse? (% of subjects answering this question)||Percentage of participants|||Number
761242|NCT00638235|Secondary|Patient Satisfaction Questionnaire at 12 Months by Question (Q#3)|Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 12 months post-procedure.|12 months|Would you recommend this procedure to a friend suffering from prolapse? (% of subjects answering this question)||Percentage of participants|||Number
761243|NCT00638235|Secondary|Patient Satisfaction Questionnaire at 6 Months by Question (Q#3)|Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure.|6 months|Would you recommend this procedure to a friend suffering from prolapse? (% of subjects answering this question)||Percentage of participants|||Number
761244|NCT00638235|Secondary|Patient Satisfaction Questionnaire at 24 Months by Question (Q#2)|"Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 24 months post-procedure.
Note:
Phase VI ended after 12M follow up visit because the next generation of the study device was already under clinical evaluation in Phase VII
Phase II ended early before all subjects reached their 24M visit because the study device is no longer marketed due to release of models with enhancements to the design"|24 months|How satisfied are you with the outcome of your prolapse surgery? (% of subjects answering this question)||Percentage of participants|||Number
761245|NCT00638235|Secondary|Patient Satisfaction Questionnaire at 12 Months by Question (Q#2)|Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 12 months post-procedure.|12 months|How satisfied are you with the outcome of your prolapse surgery? (% of subjects answering this question)||Percentage of participants|||Number
761246|NCT00638235|Secondary|Patient Satisfaction Questionnaire at 6 Months by Question (Q#2)|Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure.|6 months|How satisfied are you with the outcome of your prolapse surgery? (% of subjects answering this question)||Percentage of participants|||Number
761247|NCT00638235|Secondary|Patient Satisfaction Questionnaire at 24 Months by Question (Q#1)|"Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure.
Note:
Phase VI ended after 12M follow up visit because the next generation of the study device was already under clinical evaluation in Phase VII
Phase II ended early before all subjects reached their 24M visit because the study device is no longer marketed due to release of models with enhancements to the design"|24 months|Overall, what outcome do you feel you have achieved after having this surgery? (% of subjects answering this question)||Percentage of participants|||Number
761291|NCT00638963|Secondary|Total Dose of Temozolomide Taken|This outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed.|Baseline to 24 Weeks|||Milligrams||Standard Deviation|Mean
761249|NCT00638235|Secondary|Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 24 Months|"The POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.
Note:
Phase VI ended after 12M follow up visit because the next generation of the study device was already under clinical evaluation in Phase VII
Phase II ended early before all subjects reached their 24M visit because the study device is no longer marketed due to release of models with enhancements to the design"|24 months|POP-Q analysis employed last failure carried forward method, which carries subject’s objective failure at previous visits if the results are missing in the visit of interest. It’s also considers re-operation for recurrent in study compartment as failure. 95% CI calculated via binominal distribution including only subjects w/POP-Q≥II at baseline.||Percentage of participants||95% Confidence Interval|Number
761250|NCT00638235|Secondary|Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 6 Months|The POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.|6 months|POP-Q analysis employed last failure carried forward method, which carries subject’s objective failure at previous visits if the results are missing in the visit of interest. It’s also considers re-operation for recurrent in study compartment as failure. 95% CI calculated via binominal distribution including only subjects w/POP-Q≥II at baseline.||Percentage of participants||95% Confidence Interval|Number
761251|NCT00638235|Secondary|Surgical Revision Rate|The monitoring of AEs occured through the end of the follow up period. Any continuing AEs past the 24M visit or early exit of subject was not followed to resolution.|Through 24 months|Percentage of total subjects experienced surgical revision (%)||Percentage of participants|||Number
761252|NCT00638235|Secondary|Patient Satisfaction Questionnaire at 6 Months by Question (Q#1)|Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure.|6 Months|Overall, what outcome do you feel you have achieved after having this surgery? (% of subjects answering this question)||Percentage of participants|||Number
761253|NCT00638235|Secondary|Wong-Baker Faces Pain Scale at 6 Weeks Post Procedure|"Pain – defined as the level of pain or discomfort associated with the pelvic area measured by the Wong-Baker Faces Pain Scale (scale of 0-10, with 10 indicating hurts worst) at baseline, and 6 weeks post procedure"|baseline and 6 weeks|Changes in pain scores between follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.||scores on a scale||Standard Deviation|Mean
761254|NCT00638235|Secondary|Rates of de Novo or Worsening Urinary and/or Anal Incontinence|Rate of subjects experiencing de novo or worsening urinary and or/ anal incontinence|Through 24 months|Rate of subjects experiencing different type of incontinenece (%)||Percentage of participants|||Number
761255|NCT00638235|Secondary|Rate of Graft Extrusions|Rate of Graft Extrusion pertains to study device graft exposure/protrusion through the vaginal wall|Through 24 months|Rate of subjects experiencing graft exposure through the vagina (%)||Percentage of participants|||Number
761256|NCT00638235|Secondary|Percent of Subjects Experiencing Major Device Related Complications|This may have included: perforation of internal organs during the implant procedure; graft erosion; serious infection requiring intravenous antibiotics; death, related to procedure or device; blood loss related to device placement which may have required blood transfusion during the procedure|Through 24 months|Total subjects experienced major complications(%)||Percentage of participants|||Number
761257|NCT00638235|Secondary|Estimated Blood Loss|Estimated Blood Loss – defined as the estimated blood loss associated with the implantation of the study device, measured in ml|Approximately 30 minutes|||milliliters||Standard Deviation|Mean
761258|NCT00638235|Secondary|Procedural Time|Procedural time was measured as the time between the first incision to place the study device and the time to close the vaginal incision for the study device. Procedure duration in minutes|Approximately 30 minutes|||minutes||Standard Deviation|Mean
761259|NCT00638235|Secondary|QoL Status – Defined as the Improvement in Subjects’ QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12|"Quality of Life as measure by Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). A higher or increasing score represents an improvement in perceived sexual function versus baseline.
Changes in QoL scores between follow-up and baseline were presented. Only those subjects who completed both baseline and follow-up were included."|6 Months|Changes in QoL scores between follow-up and baseline were presented. Only those subjects who completed both baseline and follow-up were included.||scores on a scale||Standard Deviation|Mean
761260|NCT00638235|Primary|Percent of Subjects With an ICS (International Incontinence Society) POP-Q (Pelvic Organ Prolapse Quantification System) Stage of </= Stage I in the Posterior Compartment at One Year Post Procedure|Analysis includes only subjects with posterior vaginal wall prolapse >= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.|12-months|"Analysis conducted only for those subjects with posterior vaginal wall prolapse >= stage II at baseline. Where a zero is indicated, no subjects meeting this criteria were enrolled."||percentage of participant||95% Confidence Interval|Number
790688|NCT00877929|Secondary|BP Control (SBP<140 mmHg, DBP<90 mmHg) at Four Weeks|Mean seated SBP<140 mmHg and mean seated DBP<90 mmHg|Baseline, week 4|Treated set using LOCF||participants|||Number
761262|NCT00638378|Secondary|Number of Participants With a Complete Response or Partial Response|Complete Response (CR) and Partial Response (PR) defined by the Response Evaluation Criteria in Solid Tumor (RECIST) criteria. CR: Disappearance of all target and nontarget lesions. PR: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter, or persistence of 1 or more nontarget lesion(s) or/and maintenance of tumor marker level above the normal limits.|From Baseline through the end of study (up to 8 months)|According to the protocol, the sponsor decided to close the study after it was determined that less than 2 of the first 22 patients showed a PSA50 response. Given that all patients discontinued the study due to lack of efficacy, the secondary endpoint of tumor response rate was not assessed.||Participants|||Number
761263|NCT00638378|Primary|Number of Participants With Adverse Events (AE)|A treatment-related AE was defined as an event with a definite, probable, or possible causality to study medication. A serious AE is an event resulting in death, hospitalization, persistent or significant disability/incapacity, or is life threatening, a congenital anomaly/birth defect or requires medical or surgical intervention to prevent 1 of the outcomes above. The intensity of an AE was graded according to the National Cancer Institute common terminology criteria for adverse events (NCI-CTCAE) version 3.0: Grade 1 (Mild); Grade 2 (Moderate); Grade 3 (Severe); Grade 4 (life-threatening).|From Baseline through to the end of study (up to 8 months)|The Safety population included all enrolled patients who received at least 1 dose of study medication.||Participants|||Number
761264|NCT00638378|Secondary|Time to Progression|"The time from first dosing day to the date of disease progression:
Progressive measurable disease by RECIST criteria (regardless of bone scan or prostate-specific antigen (PSA) results).
Development of unequivocal new lesions on bone scan without clinical suspicion of a “flare” reaction.
In patients who responded or had a decreased PSA from Baseline, a rise of 50% from PSA nadir, if the increase is ≥ 5 ng/mL or back to Baseline and confirmed by a 2nd value.
In patients with no decrease in PSA from Baseline, a 25% rise over Baseline and ≥ 5 ng/mL confirmed by a 2nd value."|From Baseline until the end of study (up to 8 months).|According to the protocol, the sponsor decided to close the study after it was determined that less than 2 of the first 22 patients showed a PSA50 response. Given that all patients discontinued the study due to lack of efficacy, the secondary endpoint of median time to progression was not assessed.||months||95% Confidence Interval|Median
761265|NCT00638378|Primary|Number of Participants With a Prostate-specific Antigen Response|A prostate-specific antigen (PSA) response was defined as a PSA decline from Baseline of 50% or greater, repeated on 2 occasions at least 4 weeks apart.|Assessed monthly from Baseline until the end of study (up to 8 months)|The Intent-to-treat population, which included all patients enrolled in the study who took at least 1 dose of study medication.||participants|||Number
761266|NCT00638443|Secondary|Patient Global Assessment (PGA)|Subjects were asked to rate their low back pain according to the PGA. PGA is the impact of disease activity. PGA was measured on a 5-point scale, where 1=very good, 2=good, 3=fair, 4=poor, and 5=very poor.|10 days|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.||units on a scale||Standard Error|Mean
761267|NCT00638443|Secondary|Roland Morris Disability Questionnaire|The RMDQ consists of 24 yes/no statements about activity limitations due to back pain. These questions center on movement, ambulation, and self-care activities. Positive (yes) answers each contribute 1 point to cumulative score with total scores ranging from 0 (no disability) to 24 (severely disabled).|10 days|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.||units on a scale||Standard Error|Mean
761268|NCT00638443|Secondary|Modified Brief Pain Inventory (mBPI)- Interference Score|The mBPI is a series of questions that rates the severity and impact of pain on daily function. The questionnaire is made up of 4 pain severity items using the NRS scale, and seven pain interference sub-scales. The final interference score is an average of the seven sub-scales (0 indicating no interference and 10 indicating complete interference).|10 days|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.||units on a scale||Standard Error|Mean
761269|NCT00638443|Secondary|Swiss Spinal Stenosis- Physical Function|The SSS is a series of questions asking about symptom severity, physical function, and satisfaction. The physical function section is a series of 5 questions (maximum 4 points per question) and asks to rate function for each question based on comfortably, sometimes with pain, always with pain, no functional ability. The total score (max=20) is divided by five. The maximum score for the physical function section (max=4) indicates no ability to function.|10 days|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.||units on a scale||Standard Error|Mean
761270|NCT00638443|Secondary|Swiss Spinal Stenosis (SSS) Score- Symptom Severity|The SSS is a series of questions asking about symptom severity, physical function, and satisfaction. The symptom severity section is a set of 7 questions (maximum score is 5 points per question) and asks to rate pain for each question based on no pain, mild, moderate, severe or very severe pain. The total score (maximum=35) is added up and divided by seven. The maximum score for the symptom severity section (score=5) indicates very severe symptom severity.|10 days|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.||units on a scale||Standard Error|Mean
761271|NCT00638443|Secondary|Oswestry Disability Index (ODI) Score|The ODI is a set of 10 questions each with five choices (maximum score of 5 points per question) designed to determine how back pain has affected the ability to manage everyday life (pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social life, traveling, and change positions). A total score range of 0-50; score of 0 indicates no disability and a score of 50 would indicate 100% disability.|10 days|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.||units on a scale||Standard Error|Mean
761272|NCT00638443|Secondary|Visual Analog Scale (VAS)|The VAS asked subjects to place a mark indicative of their low back pain during the past day on a 100mm line, with 0mm representing no pain and 100mm representing extreme pain.|10 days|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.||units on a scale||Standard Deviation|Mean
761292|NCT00638963|Secondary|Number of Days on Temozolomide Treatment|This outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed.|Baseline to 24 Weeks|||Days||Standard Deviation|Mean
761273|NCT00638443|Secondary|Area Under the Curve|Subjects were instructed to walk on the treadmill and to tell the research coordinator to stop testing when they reached the point at which they typically would need to stop and sit down, or until 15 minutes had elapsed. At defined intervals (every 30 seconds) subjects were asked what their pain level was according to the NRS. The area under the curve of present pain intensity multiplied by the amount of time the subject walked.|10 days|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.||units on a scale * minutes||Standard Error|Mean
761274|NCT00638443|Secondary|Recovery Time|After the subject completed the treadmill test they were asked to immediately return to the seated position. At this point a timer was started. When the subjects pain level returned to baseline (level of pain subject felt in a seated position before walking) the time was stopped. This was recorded as recovery time. Maximum recovery time is 15 minutes.|10 days|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.||minutes||Standard Error|Mean
761275|NCT00638443|Secondary|Total Distance|Subjects were instructed to walk on the treadmill and to tell the research coordinator to stop testing when they reached the point at which they typically would need to stop and sit down, or until 15 minutes had elapsed. When the subject reached their maximum distance, the treadmill testing was stopped. This was recorded as total distance based on number of minutes and seconds walked. Minutes was converted to meters based on calculation of defined speed of the treadmill.|10 days|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.||meters||Standard Error|Mean
761276|NCT00638443|Secondary|Final Pain as Measured by NRS|Subjects were instructed to walk on the treadmill and to tell the research coordinator to stop testing when they reached the point at which they typically would need to stop and sit down, or until 15 minutes had elapsed. At defined intervals subjects were asked what their pain level was according to the NRS. When the subject reached their maximum distance, they were asked their NRS score. This was recorded as final pain intensity. Using the Numeric Rating Scale (NRS) (0=no pain, 10=worst pain imaginable)the time to first symptoms (Tfirst) with a NRS score greater than or equal to 4 (moderate pain level), with treadmill ambulation was measured.|10 days|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.||units on a scale||Standard Error|Mean
761277|NCT00638443|Primary|Time to First Symptoms of Moderate Pain|Using the Numeric Rating Scale (NRS) (0=no pain, 10=worst pain imaginable)the time to first symptoms (Tfirst) with a NRS score greater than or equal to 4 (moderate pain level), with treadmill ambulation was measured.|10 days|The analyses included all enrolled randomized subjects according to the inclusion and exclusion criteria except for the three who withdrew from the trial prior to the completion of the study. One dropped out of the study due to an adverse event (dizziness).||minutes||Standard Deviation|Mean
761278|NCT00638924|Primary|Shuttle Walk Test Distance|The distance achieved in the test in meters|baseline|20 to 30 years old, healthy and sedentary||m||Standard Deviation|Mean
761279|NCT00638924|Secondary|Heart Rate|Heart rate at baseline|baseline|20 to 30 years old, healthy and sedentary||bpm||Standard Deviation|Mean
761280|NCT00638937|Secondary|Overall Survival|"One year overall survival rate
The Kaplan-Meier method will be used."|1 year|||percentage|||Number
761281|NCT00638937|Secondary|Median Overall Survival|The Kaplan-Meier method will be used.|Up to 1 year|||months||95% Confidence Interval|Median
761282|NCT00638937|Secondary|Progression-free Survival|"Progression free survival (PFS) is defined as the time from randomization to the date of first documented disease progression or death from any cause
The Kaplan-Meier method will be used."|6 months|||months||95% Confidence Interval|Median
761283|NCT00638937|Secondary|Median Progression-free Survival|The Kaplan-Meier method will be used.|From the date of study enrollment to the time the criteria for disease progression are met, death or last contact, or the last tumor assessment before the initiation of further anticancer therapy, assessed up to 1 year||||||
761284|NCT00638937|Secondary|Duration of Response or Stable Disease|Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible.|From first response until the criteria for progression are met, assessed up to 1 year|||months||95% Confidence Interval|Median
761285|NCT00638937|Secondary|Stable Disease Rate|"Stabilization of disease for atleast 4 cycles, leading to disease control
Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible."|From the start of the treatment until the criteria for progression are met, assessed up to 1 year|||participants|||Number
761286|NCT00638937|Secondary|Objective Response Rate (Complete and Partial Response)|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions Overall Response (OR) = CR + PR
Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible."|From the start of the treatment until the criteria for response are met|||participants|||Number
761287|NCT00638937|Primary|Rate of Disease Control (Freedom From Disease Progression)|"Lack of disease progression, a combined rate of objective complete (disapprearance of all target lesions) and partial responses (>= 30% decrease in sum of longest diameter of target lesions) and stable disease as determined by Response Evaluation Criteria in Solid Tumours (RECIST 1.0) for at least 4 cycles (16 weeks) of therapy.
Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible."|112 days|||participants|||Number
761288|NCT00638963|Secondary|Number of Participants Who Completed the Third Cycle of Treatment|This outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed.|Baseline to 24 Weeks|||Participants|||Number
761289|NCT00638963|Secondary|Number of Participants Who Had at Least One Treatment Omission During Treatment|This outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed.|Baseline to 24 Weeks|||Participants|||Number
761298|NCT00638989|Secondary|Volume of Distribution at Steady State (Vss) After Intravenous Infusion|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Volume of distribution at steady state (Vss) after intravenous dosing was estimated by the formula Vss=MRT(Infinity)*CL, where MRT(Infinity)= AUCM(Infinity)/AUC(0 - infinity) where MRT(Infinity) = mean residence time at infinity, CL= clearance, AUCM[Infinity] = area under the moment curve, and AUC (0 - infinity) = area under the serum concentration versus time curve from time zero (predose) to extrapolated infinite time (0 - infinity).|Predose, end of infusion, 30 minutes, at 1, 3, 8 and 24 hours post-end of infusion on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56|PK population included all evaluable participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax.||mL||Standard Deviation|Mean
761299|NCT00638989|Secondary|Apparent Systemic Clearance (CL/F) After Intravenous Dose|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.|Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56|PK population included all evaluable participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax.||mL/day||Standard Deviation|Mean
761300|NCT00638989|Secondary|Apparent Systemic Clearance (CL/F) After Subcutaneous Dose|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after subcutaneous dose (apparent systemic clearance) is influenced by the fraction of the dose absorbed (bioavailability).|Predose, 30 minutes, at 1, 3, 8 and 24 hours post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56|PK population included all evaluable participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax.||mL/day||Standard Deviation|Mean
761301|NCT00638989|Secondary|Terminal Phase Elimination Half Life (t1/2)|Terminal phase elimination half-life is the time measured for the serum concentration to decrease by one half.|Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56|PK population included all evaluable participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax.||days||Standard Deviation|Mean
761302|NCT00638989|Secondary|Time to Reach Maximum Observed Serum Concentration (Tmax)||Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56|PK population included all evaluable participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax.||days||Full Range|Median
761303|NCT00638989|Secondary|Dose Normalized Maximum Observed Concentration (Cmax/Dose)||Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56|PK population included all evaluable participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax.||(mcg/mL)/mg||Standard Deviation|Mean
761304|NCT00638989|Secondary|Maximum Observed Serum Concentration (Cmax)||Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56|PK population included all evaluable participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax.||microgram/milliliter (mcg/mL)||Standard Deviation|Mean
761305|NCT00638989|Secondary|Dose Normalized Area Under the Concentration-time Curve From Zero to Infinity ([AUC {0 - Infinity}]/Dose)|AUC (0 - infinity) = Area under the serum concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - infinity). It is obtained from AUC (0 - t) plus AUC (t - infinity). (AUC [0 - infinity]) was normalized by CAT-354 dose.|Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56|PK population included all evaluable participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax.||([mcg*day]/mL)/mg||Standard Deviation|Mean
761306|NCT00638989|Secondary|Area Under the Serum Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC[0 - 56])||Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56|PK population included all evaluable participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax.||mcg*day/mL||Standard Deviation|Mean
761307|NCT00638989|Secondary|Area Under the Concentration-time Curve From Zero to Infinity (AUC [0 - Infinity])|AUC (0 - infinity) = Area under the serum concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - infinity). It is obtained from AUC (0 - t) plus AUC (t - infinity).|Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56|PK population included all evaluable participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax.||(microgram*day)/milliliter (mcg*day/mL)||Standard Deviation|Mean
761308|NCT00638989|Secondary|Number of Participants Exhibiting Anti-Drug Antibodies for CAT-354 at Any Visit||Day 0 and Day 56|Safety population included all participants randomized to treatment, and received at least 1 dose of study medication.||participants|||Number
761309|NCT00638989|Secondary|Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between administration of study drug and up to Day 56 that were absent before treatment or that worsened relative to pre-treatment state.|Day 0 to 56|Safety population included all participants randomized to treatment, and received at least 1 dose of study medication.||participants|||Number
761381|NCT00640016|Secondary|Minimum Observed Serum Concentration (Cmin) for CAT-354||Predose, 10 minutes and 6 hours post-end of infusion on Day 0, 28 and 56|PK population included all participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||mcg/mL||Standard Deviation|Mean
761310|NCT00638989|Primary|Absolute Bioavailability of CAT-354 After Subcutaneous Dose|Bioavailability (F) is a measurement of the rate and extent to which a drug reaches the systemic circulation. Absolute bioavailability of the subcutaneous doses was assessed by the geometric least-square means ratios of subcutaneous to intravenous dose-normalized area under the serum concentration-time curve from time zero to infinity (AUC [0 - infinity]/Dose). AUC (0 - infinity) = Area under the serum concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - infinity). It is obtained from AUC (0 - t) plus AUC (t - infinity).|Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56|Pharmacokinetic (PK) population included all evaluable participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate maximum observed serum concentration (Cmax).||percent bioavailability||90% Confidence Interval|Geometric Mean
761311|NCT00639002|Secondary|Time to Disease Progression According to the International Uniform Response Criteria for Multiple Myeloma|"Progressive Disease requires 1 or more of the following:
Increase of ≥ 25% from baseline in:
Serum M-component and/or (increase ≥ 0.5 g/dL).
Urine M-component and/or (increase ≥ 200 mg/24 h).
In patients without measurable serum and urine M-protein levels the difference between involved and uninvolved FLC levels increase must be > l0 mg/dL.
Bone marrow plasma cell percentage ≥ 10%.
Definite development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas.
Development of hypercalcemia."|Day 1 of Cycles 2, 3, and 4 and then every 3 months thereafter (up to 25 months).|Intent-to-treat population. This outcome measure was not analyzed as no patients achieved a response.||Months||Standard Deviation|Mean
761312|NCT00639002|Primary|Number of Responders According to the International Uniform Response Criteria for Multiple Myeloma|A responder is defined as a patient with a complete response (negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow) or a partial response (≥ 50% reduction of serum M-protein and reduction in 24 h urinary M-protein by ≥ 90% or to < 200 mg per 24 h).|Day 1 of Cycles 2, 3, and 4 and then every 3 months thereafter (up to 25 months).|Intent-to-treat population: All patients who were enrolled and took at least 1 dose of study medication.||participants|||Number
761313|NCT00639093|Secondary|Tiffany's Urge to Smoke Questionnaire||Weeks 1, 4, 6, 12, 24 and 12-month follow-up||||||
761314|NCT00639093|Primary|Self-report Measure of Abstinence in the Last 7 Days, Averaged Over Four Weeks, and Confirmed by Urine Samples.|"Participants completed a daily diary to record the number cigarettes smoked during the day. No cigarette smoked during 7 days = abstinence. To be counted as real abstinence, the participant had to smoke zero cigarettes during four weeks and confirmed by zero nicoting in the unrine sample.
Six measurement times were used to assess if zero cigarettes has been smoked in the last 4 weeks prior to the study (Week 1), during the first four weeks (Week 4 measurement point) and so on for a blok of four weeks ending at each measurement point (e.g., four weeks before the 12-month follow-up)."|Weeks 1, 4, 6, 12, 24 and 12-month follow-up|||participants|||Number
761315|NCT00639158|Secondary|Median Percent Change in High-Sensitivity C-Reactive Protein (hsCRP) From Baseline to Final Visit|[(Week 12 hsCRP minus baseline hsCRP)/baseline hSCRP] x 100|Baseline to 12 weeks (Final Visit)|All randomized subjects with a baseline hsCRP value and at least 1 postbaseline hsCRP value, last observation carried forward.||Percent change||Inter-Quartile Range|Median
761316|NCT00639158|Secondary|Mean Percent Change in Apolipoprotein B (apoB) From Baseline to Final Visit|[(Week 12 apoB minus baseline apoB)/baseline apoB] x 100|Baseline to 12 weeks (Final Visit)|All randomized subjects with a baseline apoB value and at least 1 postbaseline apoB value, last observation carried forward.||Percent change||Standard Error|Mean
761317|NCT00639158|Secondary|Mean Percent Change in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Final Visit|[(Week 12 non-HDL-C minus baseline non-HDL-C)/baseline non-HDL-C] x 100|Baseline to 12 weeks (Final Visit)|All randomized subjects with a baseline non-HDL-C value and at least 1 postbaseline non-HDL-C value, last observation carried forward.||Percent change||Standard Error|Mean
761318|NCT00639158|Secondary|Mean Percent Change in Apolipoprotein CIII (apoCIII) From Baseline to Final Visit|[(Week 12 apoCIII minus baseline apoCIII)/baseline apoCIII] x 100|Baseline to 12 weeks (Final Visit)|All randomized subjects with a baseline apoCIII value and at least 1 postbaseline apoCIII value, last observation carried forward.||Percent change||Standard Error|Mean
761319|NCT00639158|Secondary|Mean Percent Change in Very Low-Density Lipoprotein Cholesterol (VLDL-C) From Baseline to Final Visit|[(Week 12 VLDL-C minus baseline VLDL-C)/baseline VLDL-C] x 100|Baseline to 12 weeks (final visit)|All randomized subjects with a baseline VLDL-C value and at least 1 postbaseline VLDL-C value, last observation carried forward.||Percent change||Standard Error|Mean
761320|NCT00639158|Primary|Mean Percent Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit|[(Week 12 HDL-C minus baseline HDL-C)/baseline HDL-C] x 100|Baseline to 12 weeks (Final Visit)|All randomized subjects with a baseline high density lipoprotein cholesterol (HDL-C) value and at least 1 postbaseline HDL-C value, last observation carried forward.||Percent change||Standard Error|Mean
761321|NCT00639158|Secondary|Mean Percent Change in Apolipoprotein AI (apoAI) From Baseline to Final Visit|[(Week 12 apoAI minus baseline apoAI)/baseline apoAI] x 100|Baseline to 12 weeks (Final Visit)|All randomized subjects with a baseline apoAI value and at least 1 postbaseline apoAI value, last observation carried forward.||Percent change||Standard Error|Mean
761322|NCT00639158|Primary|Median Percent Change in Triglycerides From Baseline to Final Visit|[(Week 12 triglycerides minus baseline triglycerides)/baseline triglycerides] x 100|Baseline to 12 Weeks (Final Visit)|All randomized subjects with a baseline triglyceride value and at least 1 postbaseline triglyceride value, last observation carried forward.||Percent change||Inter-Quartile Range|Median
761323|NCT00639223|Secondary|Change in LDL-Cholesterol Measured at the Beginning and End of the Study||12 weeks|||Percentage Change||Standard Deviation|Mean
761324|NCT00639223|Primary|Withdrawal of Therapy Due to Muscle Symptoms That Are Either Intolerable and/or Associated With a Creatine Kinase(CK) >500||12 weeks|||Participants|||Number
761325|NCT00639379|Primary|Overall Corneal Staining|Corneal staining measured using the National Eye Institute grading scale of grade 0 = normal, grade 1 = mild, grade 2 = moderate, grade 3 = severe.|after 2 weeks use|Subjects that completed the study were analyzed.||Units on a scale||Standard Error|Least Squares Mean
767736|NCT00697593|Primary|Biochemistry - Sodium|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 1 participant missing values||mmol/L||Standard Deviation|Mean
761326|NCT00639379|Primary|Subjective Vision|A weighted combined score calculated from individual vision-related questions asked on a 1-5 scale: 1=most negative response to 5=most positive response, was used to derive vision outcomes. The analysis shows the difference in outcome between the test and control. >0=satisfactory vision, <0=unsatisfactory vision.|1 and 2 weeks|Subjects that completed the study were analyzed.||Units on a scale||Standard Error|Least Squares Mean
761327|NCT00639379|Primary|Subjective Lens Comfort|A weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1=most negative response to 5=most positive response, was used to derive comfort outcomes. The analysis shows the difference in outcome between the test and control. >0=comfortable, <0=uncomfortable.|1 and 2 weeks|Subjects that completed the study were analyzed.||Units on a scale||Standard Error|Least Squares Mean
761328|NCT00639379|Primary|Lens Stability|Number of eyes with the amount of rotation induced from a blink within 5 degrees of settled orientation.|10-15 minutes after insertion|Subjects/eyes that completed the study were analyzed. A total of 168 eyes/84 subjects were analyzed.||Eyes|||Number
761329|NCT00639379|Primary|Lens Orientation Within 5 Degrees|Number of eyes with lens orientation within 5 degrees of optimal orientation within 1 minute of contact lens insertion.|1 minute after insertion|Subjects/eyes that completed the study were analyzed. A total of 168 eyes/84 subjects were analyzed.||Eyes|||Number
761330|NCT00639418|Secondary|Correlation of Office Vaccination-related Attitudes and Activities With Actual Vaccine Coverage|Correlation of office attitudes related to influenza vaccination and actual vaccine coverage was explored. Sites were asked to indicate level of agreement with the following recommendations: vaccinating children with high-risk medical conditions, patients 6 months to 5 years of age should be vaccinated against influenza each year, patients 5 to 18 years of age without high-risk medical conditions should be vaccinated against influenza each year, and previously unvaccinated patients less than 9 years of age receive 2 doses of vaccine.|Seasonal: 2007-2011|||Sites|||Number
761331|NCT00639418|Secondary|Compliance With the Recommended Two-dose Regimen in Vaccinated Participants|Compliance was calculated from the total number of participants receiving 2 doses divided by the total number of participants identified as requiring a second dose.|Seasonal: 2007-2011|||percentage of participants|||Number
761332|NCT00639418|Primary|Influenza Vaccine Coverage in Participants <18 Years of Age by Age Group in Pediatric Practices|Vaccine coverage was calculated from the number of participants vaccinated in each group, divided by the total number of participants under the practice’s care in that specific age group.|Seasonal: 2007-2011|||percentage of participants|||Number
761333|NCT00639457|Secondary|Myocardial Contractility-DBP|Diastolic blood pressure; vascular pressure during ventricular relaxation (diastole)|Baseline and week 16|Number of participants for measures of myocardial contractility is less than that for all other measures. These measures were added to the protocol (after ~50% enrollment) after some reports suggested that this drug class (thiazolidinediones) may adversely affect heart function.||mmHg||Standard Error|Mean
761334|NCT00639457|Secondary|Myocardial Contractility-SBP|Systolic blood pressure; peak vascular pressure during ventricular contraction|Baseline and week 16|Number of participants for measures of myocardial contractility is less than that for all other measures. These measures were added to the protocol (after ~50% enrollment) after some reports suggested that this drug class (thiazolidinediones) may adversely affect heart function.||mmHg||Standard Error|Mean
761335|NCT00639457|Secondary|Myocardial Contractility-DT|Deceleration time; time from the peak of early diastolic filling to baseline|Baseline and week 16|Number of participants for measures of myocardial contractility is less than that for all other measures. These measures were added to the protocol (after ~50% enrollment) after some reports suggested that this drug class (thiazolidinediones) may adversely affect heart function.||msec||Standard Error|Mean
761336|NCT00639457|Secondary|Myocardial Contractility-LV Ejection Time|Time required to empty the left ventricle into the aorta|Baseline and week 16|Number of participants for measures of myocardial contractility is less than that for all other measures. These measures were added to the protocol (after ~50% enrollment) after some reports suggested that this drug class (thiazolidinediones) may adversely affect heart function.||msec||Standard Error|Mean
761337|NCT00639457|Secondary|Myocardial Contractility|E/A ratio; ratio of the early (E) to late (A) ventricular filling velocities|Baseline and week 16|Number of participants for measures of myocardial contractility is less than that for all other measures. These measures were added to the protocol (after ~50% enrollment) after some reports suggested that this drug class (thiazolidinediones) may adversely affect heart function.||ratio||Standard Error|Mean
761338|NCT00639457|Secondary|Serum Adiponectin Levels||Baseline and week 16|||µg/mL||Standard Error|Mean
761339|NCT00639457|Secondary|Hematocrit|Percentage of blood volume that is red cells|Baseline and Week 16|||% red cells||Standard Error|Mean
761340|NCT00639457|Secondary|Hemoglobin||Baseline and Week 16|||g/L||Standard Error|Mean
761341|NCT00639457|Secondary|Liver Enzyme Levels||Baseline and week 16|||U/L||Standard Error|Mean
761342|NCT00639457|Secondary|Serum Lipid and Lipoprotein Levels||Baseline and week 16|||mM/L||Standard Error|Mean
761343|NCT00639457|Secondary|Hepatic Glucose Production Rate|ability of insulin to suppress hepatic glucose production = hepatic insulin sensitivity|Baseline and week 16|||percent suppression||Standard Error|Mean
761344|NCT00639457|Secondary|Hepatic Lipid Content||Baseline and week 16|||percent of water||Standard Error|Mean
761345|NCT00639457|Secondary|Abdominal Subcutaneous Fat Volume||Baseline and week 16|||cm3||Standard Error|Mean
761346|NCT00639457|Secondary|Visceral Fat Volume||Baseline and week 16|||cm3||Standard Error|Mean
761347|NCT00639457|Primary|Insulin-stimulated Glucose Disposal Rate|Insulin-mediated glucose disposal rate per kg of fat free mass per min|Baseline and week16|||µmol glucose/kg FFM/min||Standard Error|Mean
761348|NCT00639509|Secondary|Median Overall Survival|Median Overall Survival|Post-Treatment|||months||95% Confidence Interval|Median
761349|NCT00639509|Primary|Best Overall Response Rate (ORR)|Best overall ORR will be defined as the proportion of patients achieving either confirmed partial response (PR) or confirmed complete response (CR). A Simon’s optimal two stage design will be used with the following assumption: ORR of more than 20% is acceptable and an ORR less than 5% is not acceptable.|From the start of the treatment until disease progression/recurrence|||participants|||Number
767737|NCT00697593|Primary|Hematology - Platelet Count|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 4 participants missing values||x10^9/L||Standard Deviation|Mean
761350|NCT00639509|Primary|PFS Rate|PFS defined as the time from first date of first treatment on the study until such time as progressive disease is confirmed or upon patient death if disease progression has not been evident at that time. A Simon’s optimal two stage design will be used with the following assumption: a 4 months PFS of 62% is considered acceptable while a 4 months PFS of 42% is not acceptable.|At 4 months|||percentage of participants||95% Confidence Interval|Number
761351|NCT00639678|Secondary|Mean Raxibacumab Concentration-time Following Two IV Infusion Doses|Blood was collected from each participant at selected times post dose, and serum specimens were analyzed for raxibacumab using a validated electrochemiluminescense-based assay. The individual serum raxibacumab concentration data were summarized by nominal collection time and treatment group using descriptive statistics. For the participants that received two doses, blood samples for serum raxibacumab concentration measurement were collected from participants prior to administration of the raxibacumab and diphenhydramine doses on Days 0 and 14, at 30 minutes and 2 to 6 hours after completion of each raxibacumab infusion, and at 28, 42, 56, and 70 days after the 1st raxibacumab dose.|Pre-dose on Days 0 and 14, at 30 minutes and 2 to 6 hours after completion of each raxibacumab infusion, and at 28, 42, 56, and 70 days after the 1st raxibacumab dose|Pharmacokinetics (PK) Population: all evaluable participants who received a raxibacumab dose and had at least 1 measurable post-dose serum raxibacumab concentration.||Micrograms per milliliter (μg/mL)||Standard Deviation|Mean
761352|NCT00639678|Secondary|Mean Raxibacumab Concentration-time Following a Single IV Infusion Dose|Blood was collected from each participant at selected times post dose, and serum specimens were analyzed for raxibacumab using a validated electrochemiluminescense-based assay. The individual serum raxibacumab concentration data were summarized by nominal collection time and treatment group using descriptive statistics. Blood samples for serum raxibacumab concentration measurement were collected from participants who received a single-dose prior to administration of the raxibacumab and diphenhydramine doses on Day 0, at 30 minutes and 2 to 6 hours after completion of the raxibacumab infusion, and at 14, 28, and 56 days after the raxibacumab dose.|Pre-dose on Day 0, at 30 minutes and 2 to 6 hours after completion of raxibacumab infusion, and at 14, 28, and 56 days after the raxibacumab dose|Pharmacokinetics (PK) Population: all evaluable participants who received a raxibacumab dose and had at least 1 measurable post-dose serum raxibacumab concentration.||Micrograms per milliliter (μg/mL)||Standard Deviation|Mean
761353|NCT00639678|Primary|Number of Participants Who Developed an Anti-raxibacumab Antibody Response|Number of participants who developed an anti-raxibacumab antibody response during the study were assessed. .Immunogenicity testing was performed to determine if raxibacumab induced an anti-raxibacumab immune response. Testing comprised of 2 assays (screening and confirmatory). The screening assay (direct binding) was an electrochemiluminescence (ECL)-based bridging assay. A rabbit polyclonal antibody was used as a positive control. Samples above the assay cut point were considered positive. Samples identified as positive in the screening assay were confirmed positive in a confirmatory assay. Samples must have demonstrated a significant percent drop in the confirmatory inhibition of binding assay to be considered positive. The inhibition of binding confirmatory assay was performed identically to the direct binding screening assay with the exception that the samples were tested in parallel with excess unlabeled raxibacumab.|From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)|As-treated population||Participants|||Number
761354|NCT00639678|Primary|Number of Participants With at Least a 2-grade Worsening From Baseline in Urinalysis Toxicities|Urinalysis parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable. Baseline is defined as the value of the variable measured at Day 0 prior to dosing.|From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)|As-treated population||Participants|||Number
761355|NCT00639678|Primary|Number of Participants With Urinalysis Toxicities of the Indicated Grade|Urinaysis parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.|From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)|As-treated population||Participants|||Number
761356|NCT00639678|Primary|Number of Participants With Thyroid Toxicities of the Indicated Grade|Clinical thyroid parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.|From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)|As-treated population||Participants|||Number
761380|NCT00640016|Secondary|Area Under the Serum Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC [0 - t]) for CAT-354||Predose, 10 minutes and 6 hours post-end of infusion on Day 0, 28 and 56|PK population included all participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||microgram*day/milliliter (mcg*day/mL)||Standard Deviation|Mean
790689|NCT00877929|Secondary|BP Control (SBP<140 mmHg, DBP<90 mmHg) at Six Weeks|Mean seated SBP<140 mmHg and mean seated DBP<90 mmHg|Baseline, week 6|Treated set using LOCF||participants|||Number
761357|NCT00639678|Primary|Number of Participants With at Least a 2-grade Worsening From Baseline in Other Chemistry Toxicities|The number of participants with at least a 2-grade worsening from Baseline in other chemistry toxicities were assessed. Other clinical chemistry parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable. Baseline is defined as the value of the variable measured at Day 0 prior to dosing.|From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)|As-treated population||Participants|||Number
761358|NCT00639678|Primary|Number of Participants With Other Chemistry Toxicities of the Indicated Grade|Other chemistry parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.|From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)|As-treated population||Participants|||Number
761359|NCT00639678|Primary|Number of Participants With at Least a 2-grade Worsening From Baseline in Electrolyte Toxicities|The number of participants with at least a 2-grade worsening from Baseline in electrolyte toxicities were assessed. Electrolyte function parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable. Baseline is defined as the value of the variable measured at Day 0 prior to dosing.|From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)|As-treated population||Participants|||Number
761360|NCT00639678|Primary|Number of Participants With Electrolyte Toxicities of the Indicated Grade|Electrolyte function parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.|From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)|As-treated population||Participants|||Number
761361|NCT00639678|Primary|Number of Participants With at Least a 2-grade Worsening From Baseline in Liver Toxicities|The number of participants with at least a 2-grade worsening from Baseline in liver toxicities were assessed. Liver function parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable. Baseline is defined as the value of the variable measured at Day 0 prior to dosing.|From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)|As-treated population||Participants|||Number
761362|NCT00639678|Primary|Number of Participants With Liver Toxicities of the Indicated Grade|Liver function parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.|From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)|As-treated population||Participants|||Number
761363|NCT00639678|Primary|Number of Participants With at Least a 2-grade Worsening From Baseline in Hematological Toxicities|The number of participants with at least a 2-grade worsening from Baseline in hematological toxicities were assessed. Clinical hematological parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable. Baseline is defined as the value of the variable measured at Day 0 prior to dosing.|From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)|As-treated population||Participants|||Number
761364|NCT00639678|Primary|Number of Participants With Hematological Toxicities of the Indicated Grade|Clinical hematological parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.|From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)|As-treated population||Participants|||Number
761365|NCT00639678|Primary|Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. This includes worsening (eg, increase in frequency or severity) of pre-existing conditions. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in deciding whether reporting is appropriate in other situations. Refer to the General Adverse AE/SAE module for a complete list of AEs and SAEs.|From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)|As-treated population: all participants who received at least one dose of study agent, with the assignment to treatment based on the actual treatment received, unless otherwise specified||Participants|||Number
761366|NCT00639717|Secondary|Regulatory T Cell Numbers Post-transplant||180 days|T cell numbers were not analyzed|||||
761367|NCT00639717|Secondary|Measured Level of Circulating Plasma Markers After Transplant||100 days|Plasma markers were not analyzed.|||||
761368|NCT00639717|Secondary|The Percentage of Patients That Experienced Graft Versus Host Disease|Incidence of acute GVHD grades 2-4 and chronic GVHD in this study population|6 Months|||percentage of patients||95% Confidence Interval|Number
761369|NCT00639717|Primary|Percentage of Patients Who Experienced Relapse by 6 Months|Relapse rate at 6 months. Relapse is defined as recurrence of disease.|6 months|||Percentage of patients||95% Confidence Interval|Number
761370|NCT00639717|Primary|Percentage of Patients Alive at 6 Months|Overall survival at 6 months|6 months|||percentage of patients||95% Confidence Interval|Number
761371|NCT00639769|Secondary|Number of Patients With Each Worst-grade Toxicity|Number of patients with worst-grade toxicity response of each grade (grade 1 to 5) following NCI Common Toxicity Criteria, with grade 1=mild adverse event; 2=moderate adverse event; 3=severe and undesirable adverse event; 4=life-threatening or disabling adverse event; 5=death|6 weeks after last chemotherapy|||participants|||Number
761372|NCT00639769|Primary|Patient Response|Number of patients in each response category according to RECIST criteria: Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.|6 weeks after last chemotherapy treatment|Analysis was per protocol (7 patients did not receive a full cycle of treatment, and 1 patient was censored for incomplete records)||participants|||Number
761373|NCT00639860|Primary|New Bone Formation|Percentage of new bone formation of the alveolar bone core biopsies.|From Baseline to 12 weeks|||percentage of vital bone||Full Range|Mean
761374|NCT00639860|Primary|Radiographic Bone Changes|Radiographic measures were accomplished utilizing a real-time subtraction program, Computer Assisted Radiographic Evaluation (C.A.R.E.).|From Baseline to 12 weeks|||percentage of bone fill||Full Range|Mean
761375|NCT00639860|Primary|Change in Bone Gain or Loss in Millimeters (Stent to Apex)|Stent to apex of socket measured by a calibrated examiner using a University of North Carolina (UNC) probe.|From Baseline to 12 weeks|||mm||Full Range|Mean
761376|NCT00639860|Primary|Change in Bone Gain or Loss in Millimeters (Mesiodistal)|Socket width (mesiodistal) measured by a calibrated examiner using a University of North Carolina (UNC) probe.|From Baseline to 12 weeks|||mm||Full Range|Mean
761377|NCT00639860|Primary|Change in Bone Gain or Loss in Millimeters (Buccopalatal)|Socket width (buccopalatal) measured by a calibrated examiner using a University of North Carolina (UNC) probe.|From Baseline to 12 weeks|||mm||Full Range|Mean
761378|NCT00640016|Secondary|Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Day 84 that were absent before treatment or that worsened relative to pre-treatment state.|Day 0 to 84|Safety population included all participants who received at least 1 dose of study medication.||participants|||Number
761379|NCT00640016|Secondary|Accumulation Ratio for CAT-354 (RA)|Accumulation ratio (RA) is calculated for Cmax, Cmin and AUC as RA for Cmax = Cmax (56 - 84)/Cmax (0 - 28); Similarily, RA for Cmin = Cmin (56 - 84)/Cmin (0 - 28) and RA for AUC= AUC (56 - 84)/AUC (0 - 28) where Cmax (0 - 28) and Cmax (56 - 84) are the maximum observed serum concentration after first dose (Day 0 to Day 28) and after third dose (Day 56 to Day 84), respectively; Cmin (0 - 28) and Cmin (56 - 84) are the minimum observed serum concentration after first and third dose, respectively; AUC (0 - 28) and AUC (56 - 84) are the area under the serum concentration time curve over a dosage interval determined after first and third dose, respectively.|Predose, 10 minutes and 6 hours post-end of infusion on Day 0, 28 and 56|PK population included all participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||ratio||Standard Deviation|Mean
761382|NCT00640016|Secondary|Maximum Observed Serum Concentration (Cmax) for CAT-354||Predose, 10 minutes and 6 hours post-end of infusion on Day 0, 28 and 56|Pharmacokinetic (PK) population included all participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||microgram/milliliter (mcg/mL)||Standard Deviation|Mean
761383|NCT00640016|Secondary|Adult Asthma Quality of Life (QoL) Questionnaire Final Score|The AQLQ: a 32-item questionnaire evaluating quality of life of participants with asthma including 4 domains (symptoms, activity limitations, emotional function, and environmental stimuli). Participants are asked to recall their experiences during the previous 2 weeks and to score each of the 32 questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score is calculated as the mean response to all questions. The 4 domain scores are the means of the responses to the questions in each of the domains. Overall AQLQ score and 4 domain scores ranged from 7 (no impairment) to 1 (severe impairment).|Day 0, 28, 84 or early termination (any time before Day 84)|Data was not collected and hence, not analyzed for this outcome measure because the study was prematurely terminated on the basis of several factors namely, observed low rate of participant randomisation into the study; delay caused by temporary halt of study and potential for expiry date of investigation medicinal product before end of study.|||||
761384|NCT00640016|Secondary|Morning Peak Flow and Peak Flow Variability|Peak flow is a participant’s maximum speed of expiration.|Day 0 to Day 84|Data was not collected and hence, not analyzed for this outcome measure because the study was prematurely terminated on the basis of several factors namely, observed low rate of participant randomisation into the study; delay caused by temporary halt of study and potential for expiry date of investigation medicinal product before end of study.|||||
761385|NCT00640016|Secondary|Number of Participants With Exacerbations|Exacerbation was defined as: Mild (determined from diary data) - 2 consecutive days satisfying the same or 1 of the following criteria: any night with awakening(s) due to asthma or morning PEF 20 % or more below baseline where baseline = average of the 10 days before randomization or as-needed medication use of 2 inhalations or more in 24 hours above baseline where baseline = average of the 10 days before randomization. Severe (determined by taking an exacerbation update and history): deterioration of asthma resulting in emergency treatment or hospitalization or need for oral steroids for 3 days or more (as judged by the Investigator).|Day 0 to Day 84|Data was not collected and hence, not analyzed for this outcome measure because the study was prematurely terminated on the basis of several factors namely, observed low rate of participant randomisation into the study; delay caused by temporary halt of study and potential for expiry date of investigation medicinal product before end of study.|||||
761386|NCT00640016|Secondary|Number of Participants With Diary Data|Participants recorded asthma symptoms, use of reliever inhalers (beta-agonist use for symptom relief and as prophylaxis), and morning and evening peak expiratory flow (PEF) measurements in a diary.|Day 0, 4, 14, 28, 35, 56, 63 to Day and 84|Data was not collected and hence, not analyzed for this outcome measure because the study was prematurely terminated on the basis of several factors namely, observed low rate of participant randomisation into the study; delay caused by temporary halt of study and potential for expiry date of investigation medicinal product before end of study.|||||
761387|NCT00640016|Secondary|Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)|The FEV1 was maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration.|Day 0 to 84|Data was not collected and hence, not analyzed for this outcome measure because the study was prematurely terminated on the basis of several factors namely, observed low rate of participant randomisation into the study; delay caused by temporary halt of study and potential for expiry date of investigation medicinal product before end of study.|||||
761388|NCT00640016|Secondary|Asthma Control Questionnaire (ACQ) Total Score|The ACQ is questionnaire that comprises of 7-questions evaluating participant’s asthma control. Six self-administered questions assess asthma control over the past week covering nocturnal waking, morning symptoms, activity limitations, shortness of breath, wheezing, and short-acting bronchodilator use; using 7-point ordinal rating scale from 0 (good control) to 6 (poor control). Seventh question is completed by a health professional on forced expiratory volume in 1 second (FEV1) percentage (%) predicted; scale: 0 (greater than [>] 95% predicted) to 6 (less than [<] 50% predicted. Final score is the average score of the 7 questions, with a score range of 0 (well controlled) to 6 (extremely poor controlled). Result was summarized for sub-therapeutic dose (placebo and CAT-354 1 mg/kg) and therapeutic dose (CAT-354 5 mg/kg and CAT-354 10 mg/kg), as per planned analysis.|Baseline, Day 28, 56, 84 or early termination (any time before Day 84)|Safety population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively.||units on a scale||Standard Deviation|Mean
761389|NCT00640016|Secondary|Forced Expiratory Volume in 1 Second (FEV1) as Percentage of Forced Vital Capacity (FVC)|Percentage of FEV1 was calculated as (FEV1/FVC)*100. It signified the percentage of the total amount of air exhaled from the lungs during the first second of forced exhalation. FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Result was summarized for sub-therapeutic dose (placebo and CAT-354 1 mg/kg) and therapeutic dose (CAT-354 5 mg/kg and CAT-354 10 mg/kg), as per planned analysis.|Predose, 30 minutes and 6 hours post-end of infusion on Day 0, 28 and 56; Day 4, 14, 35, Day 63, 84 or early termination (any time before Day 84)|Safety population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively.||percentage of FVC||Standard Deviation|Mean
761390|NCT00640016|Secondary|Forced Vital Capacity (FVC)|The FVC was volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was summarized for sub-therapeutic dose (placebo and CAT-354 1 mg/kg) and therapeutic dose (CAT-354 5 mg/kg and CAT-354 10 mg/kg), as per planned analysis.|Predose, 30 minutes and 6 hours post-end of infusion on Day 0, 28 and 56; Day 4, 14, 35, 63, 84 or early termination (any time before Day 84)|Safety population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively.||liters||Standard Deviation|Mean
792645|NCT00887978|Post-Hoc|6-minute Walk Test by Background PAH Therapy: ERA Only||Baseline and 16 weeks|Subjects who were only receiving an ERA at Baseline||meters||Inter-Quartile Range|Median
761391|NCT00640016|Secondary|Forced Expiratory Volume in 1 Second (FEV1)|The FEV1 was maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FEV1 was summarized for sub-therapeutic dose (placebo and CAT-354 1 mg/kg) and therapeutic dose (CAT-354 5 mg/kg and CAT-354 10 mg/kg), as per planned analysis.|Predose, 30 minutes and 6 hours post-end of infusion on Day 0, 28 and 56; Day 4, 14, 35, 63, 84 or early termination (any time before Day 84)|Safety population included all participants who received at least 1 dose of study medication. Here 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively.||liters||Standard Deviation|Mean
761392|NCT00640016|Secondary|Change From Baseline in Doubling Concentration of Methacholine at Day 56, 84 or Early Termination|Change in doubling concentrations of methacholine was calculated as Log2 PC20 (Visit x) - Log2 PC20 (Baseline), where x was the post-baseline assessment (Day 28) and PC20 was provocative concentration of methacholine causing 20 percent fall in forced expiratory volume in 1 second (FEV1). FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Change in doubling concentration was summarized for sub-therapeutic dose (placebo and CAT-354 1 mg/kg) and therapeutic dose (CAT-354 5 mg/kg and CAT-354 10 mg/kg), as per planned analysis.|Baseline, Day 56, 84 or early termination (any time before Day 84)|Safety population included all participants who received at least 1 dose of study medication. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure, and 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively.||log2 mg/dL||Standard Deviation|Mean
761393|NCT00640016|Primary|Change From Baseline in Doubling Concentration of Methacholine at Day 28|Change in doubling concentrations of methacholine was calculated as Log2 PC20 (Visit x) - Log2 PC20 (Baseline), where x was the post-baseline assessment (Day 28) and PC20 was provocative concentration of methacholine causing 20 percent fall in forced expiratory volume in 1 second (FEV1). FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Change in doubling concentration was summarized for sub-therapeutic dose (placebo and CAT-354 1 milligram/kilogram [mg/kg]) and therapeutic dose (CAT-354 5 mg/kg and CAT-354 10 mg/kg), as per planned analysis.|Baseline and Day 28|Safety population included all participants who received at least 1 dose of study medication. Here 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively.||log2 milligram/deciliter (mg/dL)||Standard Deviation|Mean
761394|NCT00640042|Secondary|Number of Investigators Who Reported Continued Use of One or More Risk Minimization Tools Within 3 to 6 Months Post Study Completion.|The risk minimization tools include SOAPP-R, treatment agreement, urine drug test, pill counts, PPAFT, Investigator Assessment and Plan and prescription card information.|6 months post study|Number of investigators providing 6-month post study survey response (n=169); surveys were completed one per investigator.||investigators|||Number
761395|NCT00640042|Secondary|Number of Investigators Who Reported Continued Use of One or More Risk Minimization Tools Within 3 Months Post Study Completion.|The risk minimization tools include SOAPP-R, treatment agreement, urine drug test, pill counts, PPAFT, Investigator Assessment and Plan and prescription card information.|3 months post study|Number of investigators providing 3-month post study survey response (n=219); surveys were completed one per investigator.||investigators|||Number
761396|NCT00640042|Secondary|Number of Cases in Which Investigators Were Satisfied or Very Satisfied With the Utility of the Risk Minimization Program in This Study.|After each subject completed participation in the study, investigators reported satisfaction with the utility of the risk minimization program in handling each subject's particular case. The risk minimization program is a set of tools used to assist clinicians in responsibly managing pain patients prescribed Avinza. The tools include SOAPP-R, treatment agreement, urine drug test, pill counts, PPAFT (Pain Patient Follow-up Tool), Investigator Assessment and Plan and prescription card data. These tools were used at each visit to assess subject risk and to aid in the management of subject's pain.|Up to 4 months|Number of subjects with risk level assessment at Visit 4 (Week 10)||cases|||Number
761397|NCT00640042|Primary|Number of Subjects at Each Level of Risk for Opioid Misuse or Abuse at Visit 4 (Week 10)|Risk level was determined by the investigator using the subject’s SOAPP-R score, reports/ evidence of aberrant behavior and clinical judgment. Low Risk: SOAPP-R score <= 9 and no signals of aberrant behavior; Moderate Risk: SOAPP-R score <= 9 with positive signals of aberrant behavior OR SOAPP-R score = 10-21 with or without positive signals of aberrant behavior OR SOAPP-R score >= 22; High Risk: SOAPP-R score >= 22 with positive signals of aberrant behavior.|Visit 4 (Week 10)|Number of subjects with risk level assessment at Visit 4 (Week 10)||participants|||Number
761398|NCT00640042|Primary|Number of Subjects at Each Level of Risk for Opioid Misuse or Abuse at Visit 3 (Week 6)|Risk level was determined by the investigator using the subject’s SOAPP-R (Screener and Opioid Assessment for Patients with Pain® - Revised Questionnaire) score, reports/ evidence of aberrant behavior and clinical judgment. Low Risk: SOAPP-R score <= 9 and no signals of aberrant behavior; Moderate Risk: SOAPP-R score <= 9 with positive signals of aberrant behavior OR SOAPP-R score = 10-21 with or without positive signals of aberrant behavior OR SOAPP-R score >= 22; High Risk: SOAPP-R score >= 22 with positive signals of aberrant behavior.|Visit 3 (Week 6)|Number of subjects with risk level assessment at Visit 3 (Week 6)||participants|||Number
761399|NCT00640042|Primary|Number of Subjects With Treatment Emergent Adverse Events|Adverse events that occur or worsen after the first dose of Avinza|Up to 4 months|||participants|||Number
761400|NCT00640042|Primary|Difference From Baseline (Week 0) in the Average Pain Score at Visit 5 (Week 14 / End of Study)|Average pain intensity over last 24 hours rated by the subject using an 11 point numeric rating scale (ranging from 0=no pain to 10=worst pain) at Visit 5 / End of Study|Baseline (Week 0) to Visit 5 (Week 14 / End of Study)|Number of subjects with pain scores at Baseline (Week 0) and Visit 5 (Week 14 / End of Study)||units on scale||Standard Deviation|Mean
761401|NCT00640042|Primary|Difference From Baseline (Week 0) in the Average Pain Score at Visit 4 (Week 10)|Average pain intensity over last 24 hours rated by the subject using an 11 point numeric rating scale (ranging from 0=no pain to 10=worst pain) at Visit 4|Baseline (Week 0) to Visit 4 (Week 10)|Number of subjects with pain scores at Baseline (Week 0) and Visit 4 (Week 10)||units on scale||Standard Deviation|Mean
761423|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Percent of Predicted VC||Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)||Percentage||Standard Deviation|Mean
761402|NCT00640042|Primary|Difference From Baseline (Week 0) in the Average Pain Score at Visit 3 (Week 6)|Average pain intensity over last 24 hours rated by the subject using an 11 point numeric rating scale (ranging from 0=no pain to 10=worst pain) at Visit 3|Baseline (Week 0) to Visit 3 (Week 6)|Number of subjects with pain scores recorded at Baseline (Week 0) and Visit 3 (Week 6)||units on scale||Standard Deviation|Mean
761403|NCT00640315|Other Pre-specified|Mean QTcF Duration (Fridericia's Correction Formula, QTcF) - Change From Baseline to Day 3|Fridericia-corrected QTcF duration was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position.|Baseline and day 3|All subjects who received at least one dose of the trial medication were included in the safety evaluation.||msec||Standard Deviation|Mean
761404|NCT00640315|Other Pre-specified|Mean QTcB Duration (Bazett's Correction Formula, QTcB) - Change From Baseline to Day 3|Bazett-corrected QTcB duration was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position.|Baseline and day 3|All subjects who received at least one dose of the trial medication were included in the safety evaluation.||msec||Standard Deviation|Mean
761405|NCT00640315|Other Pre-specified|Mean QT Duration (QTmean) - Change From Baseline to Day 3|QT duration was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position.|Baseline and day 3|All subjects who received at least one dose of the trial medication were included in the safety evaluation.||msec||Standard Deviation|Mean
761406|NCT00640315|Other Pre-specified|Mean QRS Duration (QRSmean) - Change From Baseline to Day 3|QRS duration was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position.|Baseline and day 3|All subjects who received at least one dose of the trial medication were included in the safety evaluation.||msec||Standard Deviation|Mean
761407|NCT00640315|Other Pre-specified|Mean PR Duration (PRmean) - Change From Baseline to Day 3|PR duration was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position.|Baseline and day 3|All subjects who received at least one dose of the trial medication were included in the safety evaluation.||msec||Standard Deviation|Mean
761408|NCT00640315|Secondary|Area Under the Plasma Concentration Verse Time Curve From Zero to the Last Data Point (AUC0-tn) of Riociguat and Metabolite M1 After Single Dose of Riociguat||Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose|per-protocol population||µg*h/L||Geometric Coefficient of Variation|Geometric Mean
761409|NCT00640315|Secondary|Mean Residence Time (MRT) of Riociguat and Metabolite M1 After Single Dose of Riociguat||Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose|per-protocol population||hour||Geometric Coefficient of Variation|Geometric Mean
761410|NCT00640315|Secondary|Half-life Associated With the Terminal Slope (t1/2) of Riociguat and Metabolite M1 After Single Dose of Riociguat||Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose|per-protocol population||hour||Geometric Coefficient of Variation|Geometric Mean
761411|NCT00640315|Secondary|Time to Reach Maximum Drug Concentration in Plasma (Tmax) of Riociguat and Metabolite M1 After Single Dose of Riociguat||Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose|per-protocol population||hour||Full Range|Median
761412|NCT00640315|Secondary|Multiple Inert Gas Elimination Technique (MIGET) Analysis - Change From Baseline at 1 Hour Post Dose of Intrapulmonary Shunt Flow||Baseline and 1 hour post dose|per-protocol population (subjects with data available for this outcome measure)||Percentage of total perfusion||Standard Deviation|Mean
761413|NCT00640315|Secondary|Multiple Inert Gas Elimination Technique (MIGET) Analysis - Change From Baseline at 1 Hour Post Dose of Ventilation-perfusion Distribution Presented as Standard Deviation (SD) of Ventilation||Baseline and 1 hour post dose|per-protocol population (subjects with data available for this outcome measure)||L/MIN||Standard Deviation|Mean
761414|NCT00640315|Secondary|Multiple Inert Gas Elimination Technique (MIGET) Analysis - Change From Baseline at 1 Hours Post Dose of Ventilation-perfusion Distribution Presented as Standard Deviation (SD) of Perfusion||Baseline and 1 hour post dose|per-protocol population (subjects with data available for this outcome measure)||L/MIN||Standard Deviation|Mean
761415|NCT00640315|Secondary|Multiple Inert Gas Elimination Technique (MIGET) Analysis - Change From Baseline at 1 Hour Post Dose of Normal V/Q Perfusion||Baseline and 1 hour post dose|per-protocol population (subjects with data available for this outcome measure)||Percentage||Standard Deviation|Mean
761416|NCT00640315|Secondary|Multiple Inert Gas Elimination Technique (MIGET) Analysis - Change From Baseline at 1 Hour Post Dose of Low V/Q Perfusion||Baseline and 1 hour post dose|per-protocol population (subjects with data available for this outcome measure)||Percentage||Standard Deviation|Mean
761417|NCT00640315|Secondary|Multiple Inert Gas Elimination Technique (MIGET) Analysis - Change From Baseline at 1 Hour Post Dose of Dead Space Ventilation||Baseline and 1 hour post dose|per-protocol population (subjects with data available for this outcome measure)||Percentage of total ventilation||Standard Deviation|Mean
761418|NCT00640315|Secondary|Multiple Inert Gas Elimination Technique (MIGET) Analysis - Change From Baseline at 1 Hour Post Dose of Total Perfusion (Q)||Baseline and 1 hour post dose|per-protocol population (subjects with data available for this outcome measure)||L/min||Standard Deviation|Mean
761419|NCT00640315|Secondary|Multiple Inert Gas Elimination Technique (MIGET) Analysis - Change From Baseline at 1 Hour Post Dose of Total Ventilation (V)||Baseline and 1 hour post dose|per-protocol population (subjects with data available for this outcome measure)||L/min||Standard Deviation|Mean
761420|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Specific Diffusing Capacity||Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)||Percentage||Standard Deviation|Mean
761421|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Total Lung Capacity at the Time When the DLCO is Measured (Alveolar Volume, VA)||Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)||Percentage||Standard Deviation|Mean
761422|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)||Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)||Percentage||Standard Deviation|Mean
761426|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Maximal Expiratory Flow at 25% of Expiratory Vital Capacity (MEF25)||Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)||Percentage||Standard Deviation|Mean
761427|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Maximal Expiratory Flow at 50% of Expiratory Vital Capacity (MEF50)||Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)||Percentage||Standard Deviation|Mean
761428|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Maximal Expiratory Flow at 75% of Expiratory Vital Capacity (MEF75)||Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)||Percentage||Standard Deviation|Mean
761429|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Percent of Predicted RV||Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)||Percentage||Standard Deviation|Mean
761430|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Residual Volume (RV)||Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)||Percentage||Standard Deviation|Mean
761431|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Percent of Predicted TLC|The percent of predicted TLC was provided by investigator at site.|Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)||Percentage||Standard Deviation|Mean
761432|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Total Lung Capacity (TLC)||Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)||Percentage||Standard Deviation|Mean
761433|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of FEV1/FVC||Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)||Percentage||Standard Deviation|Mean
761434|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Percent of Predicted FVC||Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)||Percentage||Standard Deviation|Mean
761435|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Forced Vital Capacity (FVC)||Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)||Percentage||Standard Deviation|Mean
761436|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Percent of Predicted FEV1||Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)||Percentage||Standard Deviation|Mean
761437|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Forced Expiratory Volume in 1 Second (FEV1)||Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)||Percentage||Standard Deviation|Mean
761438|NCT00640315|Secondary|Blood Gas Analysis - Percentage Change From Baseline at 2 Hours Post Dose of Venous Oxygen Saturation (SvO2)|"Percent change was calculated as 100%*(value post dose - value at baseline)/ value at baseline."|Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)||Percentage||Standard Deviation|Mean
761439|NCT00640315|Secondary|Blood Gas Analysis - Percentage Change From Baseline at 2 Hours Post Dose of Arterial Oxygen Saturation (SaO2)|"Arterial blood gas analysis was performed by insertion of an indwelling arterial cannula. Percent change was calculated as 100%*(value post dose - value at baseline)/ value at baseline."|Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)||Percentage||Standard Deviation|Mean
761440|NCT00640315|Secondary|Blood Gas Analysis - Percentage Change From Baseline at 2 Hours Post Dose of Venous Oxygen Pressure (PvO2)|"Percent change was calculated as 100%*(value post dose - value at baseline)/ value at baseline."|Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)||Percentage||Standard Deviation|Mean
761441|NCT00640315|Secondary|Blood Gas Analysis - Percentage Change From Baseline at 2 Hours Post Dose of Arterial Partial Pressure of Carbon Dioxide (PaCO2)|"Arterial blood gas analysis was performed by insertion of an indwelling arterial cannula. Percent change was calculated as 100%*(value post dose - value at baseline)/ value at baseline."|Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)||Percentage||Standard Deviation|Mean
761442|NCT00640315|Secondary|Blood Gas Analysis - Percentage Change From Baseline at 2 Hours Post Dose of Arterial Partial Oxygen Pressure (PaO2)|"Arterial blood gas analysis was performed by insertion of an indwelling arterial cannula. Percent change was calculated as 100%*(value post dose - value at baseline)/ value at baseline."|Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)||Percentage||Standard Deviation|Mean
761443|NCT00640315|Secondary|Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Cardiac Index|Cardiac index was calculated as cardiac index = CO / body surface area.|From baseline up to 4 hours after administration|per-protocol population (subjects with data available for this outcome measure)||L/min/m^2||Standard Deviation|Mean
761444|NCT00640315|Secondary|Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Systemic Vascular Resistance Index (SVRI)|SVRI was calculated as SVRI = (80*(MAP - RAPmean)/CO)*body surface area|From baseline up to 4 hours after administration|per-protocol population (subjects with data available for this outcome measure)||dyn*s*cm^-5*m^2||Standard Deviation|Mean
761445|NCT00640315|Secondary|Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Systemic Vascular Resistance (SVR)|SVR was calculated as SVR = 80*(MAP-RAPmean)/CO|From baseline up to 4 hours after administration|per-protocol population (subjects with data available for this outcome measure)||dyn*s*cm^-5||Standard Deviation|Mean
761446|NCT00640315|Secondary|Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Pulmonary Vascular Resistance Index (PVRI)|PVRI was calculated as PVRI = (80*(PAPmean - PCWP)/CO)*body surface area|From baseline up to 4 hours after administration|per-protocol population (subjects with data available for this outcome measure)||dyn*s*cm^-5*m^2||Standard Deviation|Mean
761447|NCT00640315|Secondary|Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Cardiac Output (CO)|CO was measured in triplicate by the thermodilution technique|From baseline up to 4 hours after administration|per-protocol population (subjects with data available for this outcome measure)||L/min||Standard Deviation|Mean
761449|NCT00640315|Secondary|Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Diastolic Blood Pressure (DBP)|Diastolic arterial blood pressure was acquired during right heart catheterization.|From baseline up to 4 hours after administration|per-protocol population||mmHg||Standard Deviation|Mean
761450|NCT00640315|Secondary|Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Systolic Blood Pressure (SBP)|Systolic arterial blood pressure was acquired during right heart catheterization.|From baseline up to 4 hours after administration|per-protocol population||mmHg||Standard Deviation|Mean
761451|NCT00640315|Secondary|Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Heart Rate (HR)|HR was acquired during right heart catheterization|From baseline up to 4 hours after administration|per-protocol population||beats per minute||Standard Deviation|Mean
761452|NCT00640315|Secondary|Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Pulmonary Capillary Wedge Pressure (PCWP)|PCWP was acquired during right heart catheterization|From baseline up to 4 hours after administration|per-protocol population (subjects with data available for this outcome measure)||mmHg||Standard Deviation|Mean
761453|NCT00640315|Secondary|Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Diastolic Pulmonary Artery Pressure (PAPdiast)|PAPdiast was acquired during right heart catheterization|From baseline up to 4 hours after administration|per-protocol population||mmHg||Standard Deviation|Mean
761454|NCT00640315|Secondary|Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Systolic Pulmonary Artery Pressure (PAPsyst)|PAPsyst was acquired during right heart catheterization|From baseline up to 4 hours after administration|per-protocol population (subjects with data available for this outcome measure)||mmHg||Standard Deviation|Mean
761455|NCT00640315|Secondary|Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Mean Right Atrial Pressure (RAPmean)|RAPmean was reported during right heart catheterization|From baseline up to 4 hours after administration|per-protocol population (subjects with data available for this outcome measure)||mmHg||Standard Deviation|Mean
761456|NCT00640315|Primary|Maximum Drug Concentration in Plasma Divided by Dose Per kg Body Weight (Cmax,Norm) of Riociguat and Metabolite M1 After Single Dose of Riociguat||Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose|per-protocol population||kg/L||Geometric Coefficient of Variation|Geometric Mean
761457|NCT00640315|Primary|Maximum Drug Concentration in Plasma Divided by Dose (Cmax/D) of Riociguat and Metabolite M1 After Single Dose of Riociguat||Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose|per-protocol population||10^3/L||Geometric Coefficient of Variation|Geometric Mean
761458|NCT00640315|Primary|Maximum Drug Concentration in Plasma (Cmax) of Riociguat and Metabolite M1 After Single Dose of Riociguat||Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose|per-protocol population||µg/L||Geometric Coefficient of Variation|Geometric Mean
761459|NCT00640315|Primary|Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity Divided by Dose Per kg Body Weight (AUCnorm) of Riociguat and Metabolite M1 After Single Dose of Riociguat||Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose|per-protocol population||kg*h/L||Geometric Coefficient of Variation|Geometric Mean
761460|NCT00640315|Primary|Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity Divided by Dose (AUC/D) of Riociguat and Metabolite M1 After Single Dose of Riociguat||Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose|per-protocol population||10^3*h/L||Geometric Coefficient of Variation|Geometric Mean
761461|NCT00640315|Primary|Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC) of Riociguat and Metabolite M1 After Single Dose of Riociguat||Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose|per-protocol population||µg*h/L||Geometric Coefficient of Variation|Geometric Mean
761462|NCT00640315|Primary|Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Pulmonary Vascular Resistance (PVR)|PVR was calculated according to the formula PVR = 80*(PAPmean - pulmonary capillary wedge pressure)/cardiac output|From baseline up to 4 hours after administration|per-protocol population (subjects with data available for this outcome measure)||(dyn*s*cm^-5)||Standard Deviation|Mean
761463|NCT00640315|Primary|Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Mean Pulmonary Artery Pressure (PAPmean)|PAPmean was reported during right heart catheterization|From baseline up to 4 hours after administration|per-protocol population||mmHg||Standard Deviation|Mean
761464|NCT00640328|Secondary|Half Life (t1/2) of Ofatumumab in the Terminal Elimination Phase Over the Course of Weeks 0-2 and 24-26|The peripheral blood for each participant was collected and analyzed for half life. Half life is defined as the period of time required for the amount of drug in the body to be reduced by half. The average t1/2 over the course of Weeks 0-2 and 24-26 is reported.|Weeks 0-2 and 24-26|"FAS. Only those participants who contributed data at the indicated time points were analyzed (reflected by n= in the category titles)."||hours||Geometric Coefficient of Variation|Geometric Mean
761465|NCT00640328|Secondary|The Volume of Distribution at Steady State (Vss) of Ofatumumab Over the Course of Weeks 0-2 and 24-26|The peripheral blood for each participant was collected and analyzed for Vss. The average Vss over the course of Weeks 0-2 and 24-26 is reported.|Weeks 0-2 and 24-26|"FAS. Only those participants who contributed data at the indicated time points were analyzed (reflected by n= in the category titles)."||liters||Geometric Coefficient of Variation|Geometric Mean
761466|NCT00640328|Secondary|Clearance of Ofa Over the Course of Weeks 0-2 and 24-26|The peripheral blood for each participant was collected and analyzed for clearance. Clearance is the measure of efficiency with which a drug is irreversibly removed form the body. The average clearance over the course of Weeks 0-2 and 24-26 is reported.|Weeks 0-2 and 24-26|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."||liters per hour||Geometric Coefficient of Variation|Geometric Mean
761467|NCT00640328|Secondary|Time to Reach Cmax (Tmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions|The peripheral blood for each participant was collected and analyzed for tmax.|Visit 3 (Week 0), Visit 4 (Week 2),Visit 10 (Week 24), and Visit 11 (Week 26). Samples were drawn predose, immediately following the end of infusion, 10 minutes after infusion, 1 hour after infusion, and 2 hours after infusion.|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."||hours||Full Range|Median
761468|NCT00640328|Secondary|The Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Time Point (AUC(0-t)) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions|The peripheral blood for each participant was collected and analyzed to estimate the area under the plasma concetration-time curve, AUC(0-t), and was assessed using the non-compartmental method.|Visit 3 (Week 0), Visit 4 (Week 2), Visit 10 (Week 24), and Visit 11 (Week 26). Samples were drawn predose, immediately following the end of infusion, 10 minutes after infusion, 1 hour (hr) after infusion, and 2 hours after infusion.|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."||Millgram hour per liter||Geometric Coefficient of Variation|Geometric Mean
761469|NCT00640328|Secondary|The Maximum Observed Plasma Concentration (Cmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions|The peripheral blood for each participant was collected and analyzed for Cmax after the first, second, third, and fourth i.v. infusions. Assessment was performed using the noncompartmental method (this analysis is highly dependent on the estimation of total drug exposure).|Visit 3 (Week 0), Visit 4, (Week 2), Visit 10 (Week 24), and Visit 11 (Week 26). Samples were drawn predose, immediately following the end of infusion, 10 minutes after infusion, 1 hour after infusion, and 2 hours after infusion.|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."||milligrams per liter||Geometric Coefficient of Variation|Geometric Mean
761470|NCT00640328|Secondary|Ofa Drug Concentration After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) Intravenous (i.v.) Infusions|The peripheral blood for each participant was collected and analyzed for the concentration of the drug in serum. There were four infusions in the study; the third infusion at Visit 10 represents the first infusion of the second treatment period (Weeks 24-48). Data are presented for the predose concentrations.|Visit 3 (Week 0), Visit 4 (Week 2), Visit 10 (Week 24), and Visit 11 (Week 26). Samples were drawn predose, immediately following the end of infusion, 10 minutes after infusion, 1 hour after infusion, and 2 hours after infusion.|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."||milligrams per liter||Standard Deviation|Mean
761471|NCT00640328|Secondary|Total Volume of T2 Lesions at Week 24 and Week 48|The MRI scan should be performed prior to dosing and can be performed up to 4 days prior to Visits 3 and 10. An IDMC reviewed the data. The volume of T2 lesions was not a cumulative volume, but the volume measured at Visit 10 and Visit 17. T2 lesion measurements measure all lesions on the brain in terms of volume and size, measuring for new lesions or enlarging lesions.|Visit 10 (Week 24) and Visit 17 (Week 48)|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."||millimeters cubed||Standard Deviation|Mean
761472|NCT00640328|Secondary|Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)|"The MRI scan was performed prior to dosing and could be performed up to 4 days prior to Visits 3 and 10. An IDMC reviewed the data. T1 enhancing Ls are enhanced by gadolinium, are considered representative of disease activity/inflammation, and may signify a relapse. Measurement of these Ls is comparative from visit to visit. Total T1 enhancing Ls represent the total of the new T1 enhancing Ls over the entire study period. T2 L measurements measure all Ls on the brain in terms of volume and size, measuring for new or enlarging Ls. T1 hypointensive Ls are areas of permanent damage."|FTP: From Visit 3 (Week 0) up to Visit 10 (Week 24); STP: From Visit 10 (Week 24) up to Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."||lesions||Standard Deviation|Mean
761473|NCT00640328|Primary|Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Complement Activation (CH50) at Week 24 (FTP) and Week 48 (STP)|Blood samples of participants were collected for CH50 prior to and 2 hours after dosing, and the samples were sent to a Central Laboratory for analysis: Bio Analytical Research Corporation (BARC). Change from Baseline (Week 0 for the FTP; Week 24 for the STP) was calculated as the value at Weeks 24 (FTP) and 48 (STP) minus the value at Baseline. Ofa depletes (induces the cell death of) B cells. When Ofa binds to a B cell, it induces complement CH50, which in turn causes cell death via cytotoxicity. Therefore, the CH50 levels were measured to ensure that CH50 was being appropriately activated.|FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48)|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."||Units per milliliter||Standard Deviation|Mean
761474|NCT00640328|Primary|Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Temperature at Week 24 (FTP) and Week 48 (STP)|The temperature of each participant was assessed prior to infusion. Change from Baseline (Week 0 for the FTP and Week 24 for the STP) was calculated as the value at Visit 10 (Week 24) for the FTP and the value at Visit 17 (Week 48) for the STP minus the value at Baseline.|FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48)|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."||Degrees Celsius||Standard Deviation|Mean
761475|NCT00640328|Primary|Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Pulse Rate at Week 24 (FTP) and Week 48 (STP)|The pulse rate of each participant was assessed prior to infusion. Change from Baseline (Week 0 for the FTP and Week 24 for the STP) was calculated as the value at Visit 10 (Week 24) for the FTP and the value at Visit 17 (Week 48) for the STP minus the value at Baseline.|FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48)|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."||beats per minute||Standard Deviation|Mean
761476|NCT00640328|Primary|Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Blood Pressure (BP) at Week 24 (FTP) and Week 48 (STP)|Maximum (systolic) and minimum (diastolic) BP were assessed prior to infusion. Change from Baseline (Week 0 for the FTP and Week 24 for the STP) was calculated as the value at Visit 10 (Week 24) for the FTP and the value at Visit 17 (Week 48) for the STP minus the value at Baseline.|FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48)|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."||millimeters of mercury||Standard Deviation|Mean
762019|NCT00645853|Secondary|D-dimer:Median and Quartile Range at End of Treatment|Median (Lower Quartile-Upper Quartile ), ng/mL|End of treatment|Only patients who switched to one common dose, 300 mg od, are included in the AZD0837 analysis||ng/mL||Inter-Quartile Range|Median
761477|NCT00640328|Primary|Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)|Blood samples of participants were collected for the assessment of antibodies produced by B-cells (immunoglobins): immunoglobulin A, immunoglobin G, and immunoglobin M. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline.|FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."||grams per liter||Standard Deviation|Mean
761478|NCT00640328|Primary|Change From Baseline (Week 0 for the FTP,Week 24 for the STP, and Week 0 for the IFUP) in Bilirubin and Creatinine at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)|Blood samples of participants were collected for the assessment of bilirubin and creatinine. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline.|FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."||Micromoles per liter (µmol/L)||Standard Deviation|Mean
761479|NCT00640328|Primary|Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)|Blood samples of participants were collected for the assessment of bicarbonate, glucose, potassium, and urea. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline.|FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."||millimoles per liter||Standard Deviation|Mean
761480|NCT00640328|Primary|Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)|Blood samples of participants were collected for the assessment of alkaline phosphatase, AST, and ALT. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline.|FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."||Units per liter||Standard Deviation|Mean
761481|NCT00640328|Primary|Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Albumin at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)|Blood samples of participants were collected for assessment of albumin count. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 104 for the IFUP) in albumin was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline.|FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: VIsit 26 (Week 104)|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."||grams per liter||Standard Deviation|Mean
761482|NCT00640328|Primary|Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Hemoglobin Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)|Blood samples of participants were collected for assessment of hemoglobin count. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in hemoglobin was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline.|FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: Visit 26 (Week 104)|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."||Millimoles/liter||Standard Deviation|Mean
761483|NCT00640328|Primary|Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Hematocrit at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)|Blood samples of participants were collected for hematocrit assessment. Hematocrit is the percentage of blood volume (BV) that is occupied by red blood cells (RBCs). Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in hematocrit was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline. Hematocrit is measured as a percentage, i.e., volume (V) of red blood cells per volume of blood.|FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: Visit 26 (Week 104)|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."||Percentage of BV occupied by RBCs||Standard Deviation|Mean
761484|NCT00640328|Primary|Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Erythrocyte Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)|Blood samples of participants were collected for assessment of erythrocyte count. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in erythrocyte count was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline.|FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: Visit 26 (Week 104)|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."||Pico (10^12) per liter||Standard Deviation|Mean
761516|NCT00640562|Secondary|Concomitant Use of Antidepressive Drugs From Baseline to Week 12|Number of concomitant users of antidepressive drugs during the study; the number of participants analyzed refers to ITT/safety population, that is to overall participants excluding the 6 participants who did not assume any study drug administration|Change of drug use from baseline to last visi|||Participants|||Number
761485|NCT00640328|Primary|Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)|Blood samples of participants were collected for hematology assessment. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in basophils, eosinophils, leukocytes, monocytes, lymphocytes, neutrophils, and platelets count was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Week 104 for the IFUP minus the value at Baseline.|FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: Visit 26 (Week 104)|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."||Giga (10^9) per liter||Standard Deviation|Mean
761486|NCT00640328|Primary|Number of Participants With Abnormal Physical Examination Findings|The investigator performed the physical examination, which included but was not limited to: general appearance and the following body systems: lymph nodes, mouth and throat, lungs, cardiovascular, abdomen, extremities, muscular-skeletal, neurological (apart from multiple sclerosis [a brain and spinal cord disease]), and skin. All abnormal clinically relevant findings such as vein problems (venous varices), disorder of the vertebral column (vertebropathy), increased hearing loss, post operative mark (scar), and chronic skin disorder with no sweat and itching (anhidrotic eczema) were reported.|FTP: From Visit 3 (Week 0) up to Visit 10 (Week 24); STP: From Visit 10 (Week 24) up to Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)|FAS||participants|||Number
761487|NCT00640328|Primary|Number of Participants With Negative or Unconfirmed Human Anti-human Antibodies (HAHA) in Which Concentrations of Ofa Were Below 500 Nanograms Per Milliliter (ng/ml)|Participants are checked for negative (or a lack of) HAHA at Baseline, and then throughout the study, to ensure that the investigational product is not causing HAHA development. Participants with concentrations of Ofa that are missing or are above 500 nanograms per milliliter (ng/mL) are considered to have unconfirmed HAHA results.|Visit 3 (Week 0), Visit 10 (Week 24), Visit 17 (Week 48) or early withdrawal (EW), and Visit 26 (Week 104)|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."||participants|||Number
761488|NCT00640328|Primary|Number of Participants With the Indicated Critical Adverse Events (CAEs)|A CAE=treatment-related (TR) grade (G) >=3 AE on day of infusion (inf.) preventing inf. to be resumed, a TR G 3 bronchospasm during 1 inf., an AE whose severity becomes G 3 for the third time during 1 inf., infections reported as serious, a TR neurological event consistent with progressive multifocal leukoencephalopathy (PML), any malignancy, and any fatal adverse drug reaction. AE severity (assessed as G 1-5) was classified using the Common Terminology Criteria for Adverse Events v3.0: G 1=mild AE; G 2=moderate AE; G 3=severe AE; G 4=life-threatening or disabling AE; G 5=death related to AE.|FTP: From Visit 3 (Week 0) up to Visit 10 (Week 24); STP: From Visit 10 (Week 24) up to Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)|FAS||participants|||Number
761489|NCT00640328|Primary|Number of Participants With Any Adverse Event|"An Adverse Event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A list of all adverse events is reported in the Other (Non-Serious) Adverse Events section. Non-serious AEs were not collected during the Individualized Follow-up Period."|First Treatment Period (FTP): From Visit 3 (Week 0) up to Visit 10 (Week 24); Second Treatment Period (STP): From Visit 10 (Week 24) up to Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)|Full Analysis Set (FAS): all participants who had been exposed to the investigational product (IP) irrespective of their compliance to the planned course of treatment.||participants|||Number
761490|NCT00640341|Primary|Uncorrected Distance High Contrast Visual Acuity|logMAR high contrast visual acuity (VA) over all visits.|Over all visits for the 1 month study period|All eligible dispensed eyes.||LogMAR|Participants|Standard Deviation|Mean
761491|NCT00640341|Primary|Subjective Responses to Comfort-related Symptoms/Complaints|Subjective ratings of symptoms/complaints using a scale of 0 = Severe Stinging/Burning to 100 = No Stinging/Burning for each eye; 0 represented the least favorable rating and a 100 represented the most favorable rating.|Over all follow-up visits for 1 month study period|All eligible dispensed eyes.||Units on a Scale|Participants|Standard Deviation|Mean
761492|NCT00640341|Primary|Any Slit Lamp Finding > Grade 2|All dispensed eyes over all follow-up visits. Measured on a scale of 0-4 with 0=no findings and 4=severe findings. Epithelial edema, epithelial microcysts, corneal staining, limbal & bulbar injection, conjunctival abnormalities, corneal neovascularization and infiltrates were measured.|Over all follow-up visits for the 1 month study period|All dispensed eyes||Eyes|Participants||Number
761493|NCT00640393|Secondary|Dermatology Life Quality Index (DLQI) - PP|"The aim of this questionnaire is to measure how much one's skin problem has affected one's life over the week prior to the visit.
Questionnaire is patient-assessed (self-reported). DLQI scores are evaluated at each time point.
Scale is from 0 best to 30 worst.
0-1 = no effect at all on patient's life 2-5 = small effect on patient's life 6-10 = moderate effect on patient's life 11-20 = very large effect on patient's life 21-30 = extremely large effect on patient's life"|0, 84, 112, 140 and 168 days|The analysis was per protocol (PP). Participants that were not 80 percent compliant to narrow band UVB treatment at each visit and patients that missed excessive etanercept injections were excluded completely from analysis. One patient missed a visit at Day 140. Results for one were excluded because of missing DLQI questionnaire results.||Units on a scale||Standard Deviation|Mean
761494|NCT00640393|Secondary|Body Surface Area (BSA) Affected by Psoriasis - PP|"BSA scores are evaluated at each time point.
BSA is a measure of the percentage of body surface affected by psoriasis."|0, 84, 112, 140 and 168 days|The analysis was per protocol (PP). Participants that were not 80 percent compliant to narrow band UVB treatment at each visit and patients that missed excessive etanercept injections were excluded completely from analysis. One patient missed a visit at Day 140.||Percent of body affected||Standard Deviation|Mean
761517|NCT00640562|Secondary|Body Mass Index (BMI) at Week 12|Patient weight and height have been be collected in order to assess the Body Mass Index (BMI). The mean BMI values reported are assessed after 12 weeks of treatment.|12 week|||Kg/m^2||Standard Deviation|Mean
761518|NCT00640562|Secondary|Change From Screening Visit to Week 12 of Prolactin Live|Plasma prolactin live was drawn prior to morning meal at the screening visit at the last visit|12 week from screening visit to last visit|||KG||Standard Deviation|Least Squares Mean
762020|NCT00645853|Secondary|Creatinine: Absolute Change From Baseline, at End of Treatment||Baseline and End of treatment|||µmol/L||Full Range|Mean
761495|NCT00640393|Secondary|Number of Patients Attaining a PGA (Physician's Global Assessment) of 0 or 1 - PP|"Number of patients attaining a Physician's Global Assessment (PGA) of clear (0) or minimal (1).
PGA scores are evaluated at each time point.
The degree of overall lesion severity at the time of the physician's evaluation of the patient evaluated using the following scale:
0 = clear
1 = minimal
2 = mild
3 = moderate
4 = severe
5 = very severe
The scale evaluates plaque elevation, scaling and erythema."|84, 112, 140 and 168 days|The analysis was per protocol (PP). Participants that were not 80 percent compliant to narrow band UVB treatment at each visit and patients that missed excessive etanercept injections were excluded completely from analysis. One patient missed a visit at Day 140 but was compliant to protocol. And PGA was not performed for another patient (Day 168)||Participants|||Number
761496|NCT00640393|Secondary|Number of Participants Attaining a 100 Percent Reduction in PASI From Baseline (PASI-100) - PP|"Four anatomic sites - head, upper extremities, trunk and lower extremities - are assessed for erythema, induration, and desquamation. The severity of each sign is assessed using a 5-point scale:
0 = No symptoms
1 = Slight
2 = Moderate
3 = Marked
4 = Very marked
The area affected by psoriasis within a given anatomic site is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of psoriatic involvement from 0-6.
Total scale 0 = best and 72 = worst"|84, 112, 140 and 168 days|The analysis was per protocol (PP). Participants that were not 80 percent compliant to narrow band UVB treatment at each visit and patients that missed excessive etanercept injections were excluded completely from analysis. One patient missed a visit at Day 140 but was compliant to protocol.||Participants|||Number
761497|NCT00640393|Secondary|Number of Participants Attaining a 75 Percent Reductionin PASI From Baseline (PASI-75) - PP|"Four anatomic sites - head, upper extremities, trunk and lower extremities - are assessed for erythema, induration, and desquamation. The severity of each sign is assessed using a 5-point scale:
0 = No symptoms
1 = Slight
2 = Moderate
3 = Marked
4 = Very marked
The area affected by psoriasis within a given anatomic site is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of psoriatic involvement from 0-6.
Total scale 0 = best and 72 = worst"|84, 112, 140 and 168 days|The analysis was per protocol (PP). Participants that were not 80 percent compliant to narrow band UVB treatment at each visit and patients that missed excessive etanercept injections were excluded completely from analysis. One patient missed a visit at Day 140 but was compliant to protocol.||Participants|||Number
761498|NCT00640393|Secondary|Number of Participants Attaining a 90 Percent Reduction in PASI From Baseline (PASI 90) - PP|"Four anatomic sites - head, upper extremities, trunk and lower extremities - are assessed for erythema, induration, and desquamation. The severity of each sign is assessed using a 5-point scale:
0 = No symptoms
1 = Slight
2 = Moderate
3 = Marked
4 = Very marked
The area affected by psoriasis within a given anatomic site is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of psoriatic involvement from 0-6.
Total scale 0 = best and 72 = worst"|84, 112, 140 and 168 days|The analysis was per protocol (PP). Participants that were not 80 percent compliant to narrow band UVB treatment at each visit and patients that missed excessive etanercept injections were excluded completely from analysis. One patient missed a visit at Day 140 but was compliant to protocol.||Participants|||Number
761499|NCT00640393|Secondary|Number of Serious Adverse Events - ITT|"Evaluation of safety of etanercept and nbUVB as compared to etanercept alone by reporting the incidence rates of serious adverse events.
Definition: any adverse event from this study that results in one of the following outcomes, or is significant for any other reason:
death
initial or prolonged inpatient hospitalization
a life-threatening experience (that is, immediate risk of dying)
persistent or significant disability/incapacity
congenital anomaly/birth defect"|196 days|The analysis was intention to treat (ITT).||Serious adverse events|||Number
761500|NCT00640393|Secondary|Number of Infectious Adverse Events - ITT|"Evaluation of safety of etanercept and nbUVB as compared to etanercept alone by reporting the incidence rates of infectious adverse events.
Definition: An adverse event is any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
Only infectious and malignant (including any type of skin cancer) adverse events were recorded."|196 days|The analysis was intention to treat (ITT).||Infectious adverse events|||Number
761501|NCT00640393|Secondary|Number of Adverse Drug Reactions - ITT|"Evaluation of safety of etanercept and nbUVB as compared to etanercept alone by reporting the incidence rates of adverse drug reactions.
Definition: A response to a drug that is noxious and unintended and that occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function.
Only adverse drug reactions that were at least possibly related to etanercept were recorded. All symptoms observed at the injection site such as erythema, burning, edema and pruritus were recorded together as Injection Site Reaction."|196 days|The analysis was intention to treat (ITT).||Adverse drug reactions.|||Number
761502|NCT00640393|Secondary|Dermatology Life Quality Index (DLQI) - ITT|"The aim of this questionnaire is to measure how much one's skin problem has affected one's life over the week prior to the visit.
Questionnaire is patient-assessed (self-reported). DLQI scores are evaluated at each time point.
Scale is from 0 best to 30 worst.
0-1 = no effect at all on patient's life 2-5 = small effect on patient's life 6-10 = moderate effect on patient's life 11-20 = very large effect on patient's life 21-30 = extremely large effect on patient's life"|0, 84, 112, 140 and 168 days|The analysis was intention to treat (ITT) and the imputation technique was Last Observation Carried Forward (LOCF).||Units on a scale||Standard Deviation|Mean
761503|NCT00640393|Secondary|Body Surface Area (BSA) Affected by Psoriasis - ITT|"BSA scores are evaluated at each time point.
BSA is a measure of the percentage of body surface affected by psoriasis."|0, 84, 112, 140 and 168 days|The analysis was intention to treat (ITT) and the imputation technique was Last Observation Carried Forward (LOCF).||Percent of body affected||Standard Deviation|Mean
761504|NCT00640393|Secondary|Number of Patients Attaining a PGA (Physician's Global Assessment) of 0 or 1 - ITT|"Number of patients attaining a Physician's Global Assessment (PGA) of clear (0) or minimal (1).
PGA scores are evaluated at each time point.
The degree of overall lesion severity at the time of the physician's evaluation of the patient evaluated using the following scale:
0 = clear
1 = minimal
2 = mild
3 = moderate
4 = severe
5 = very severe
The scale evaluates plaque elevation, scaling and erythema."|0, 112, 140 and 168 days|The analysis was intention to treat (ITT) and the imputation technique was Non Responder (NRI).||Participants|||Number
762021|NCT00645853|Secondary|Bilirubin: Number of Patients With Bilirubin>=2xULN, Post Baseline||From baseline to Follow up|||Participants|||Number
761505|NCT00640393|Secondary|Number of Participants Attaining a 100 Percent Reduction in PASI From Baseline (PASI-100) - ITT|"Four anatomic sites - head, upper extremities, trunk and lower extremities - are assessed for erythema, induration, and desquamation. The severity of each sign is assessed using a 5-point scale:
0 = No symptoms
1 = Slight
2 = Moderate
3 = Marked
4 = Very marked
The area affected by psoriasis within a given anatomic site is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of psoriatic involvement from 0-6.
Total scale 0 = best and 72 = worst"|28 and 84 days|The analysis was intention to treat (ITT) and the imputation technique was Non-Responder (NRI).||Participants|||Number
761506|NCT00640393|Secondary|Number of Participants Attaining a 90 Percent Reduction in PASI From Baseline (PASI-90) - ITT|"Four anatomic sites - head, upper extremities, trunk and lower extremities - are assessed for erythema, induration, and desquamation. The severity of each sign is assessed using a 5-point scale:
0 = No symptoms
1 = Slight
2 = Moderate
3 = Marked
4 = Very marked
The area affected by psoriasis within a given anatomic site is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of psoriatic involvement from 0-6.
Total scale 0 = best and 72 = worst"|28 and 84 days|The analysis was intention to treat (ITT) and the imputation technique was Non-Responder (NRI).||Participants|||Number
761507|NCT00640393|Secondary|Number of Participants Attaining a 75 % Reduction in PASI From Baseline (PASI-75) - ITT|"Four anatomic sites - head, upper extremities, trunk and lower extremities - are assessed for erythema, induration, and desquamation. The severity of each sign is assessed using a 5-point scale:
0 = No symptoms
1 = Slight
2 = Moderate
3 = Marked
4 = Very marked The area affected by psoriasis within a given anatomic site is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of psoriatic involvement from 0-6.
Total scale 0 = best and 72 = worst"|28 and 84 days|The analysis was intention to treat (ITT) and the imputation technique was Non-Responder (NRI).||Participants|||Number
761508|NCT00640393|Secondary|Number of Participants Attaining a 50% Reduction From Baseline in PASI From Baseline (PASI-50) - ITT|"Four anatomic sites - head, upper extremities, trunk and lower extremities - are assessed for erythema, induration, and desquamation. The severity of each sign is assessed using a 5-point scale:
0 = No symptoms
1 = Slight
2 = Moderate
3 = Marked
4 = Very marked
The area affected by psoriasis within a given anatomic site is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of psoriatic involvement from 0-6.
Total scale 0 = best and 72 = worst"|28 and 84 days|The analysis was intention to treat (ITT) and the imputation technique was Non-Responder (NRI).||Participants|||Number
761509|NCT00640393|Secondary|Number of Participants Attaining a 100% Reduction in PASI From Baseline (PASI 100) - ITT|"Four anatomic sites - head, upper extremities, trunk and lower extremities - are assessed for erythema, induration, and desquamation. The severity of each sign is assessed using a 5-point scale:
0 = No symptoms
1 = Slight
2 = Moderate
3 = Marked
4 = Very marked
The area affected by psoriasis within a given anatomic site is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of psoriatic involvement from 0-6.
Total scale 0 = best and 72 = worst"|112, 140 and 168 days|The analysis was intention to treat (ITT) and the imputation technique was Non-Responder (NRI).||Participants|||Number
761510|NCT00640393|Secondary|Number of Participants Attaining a 75 Percent Reduction in PASI From Baseline (PASI 75) - ITT|"Four anatomic sites - head, upper extremities, trunk and lower extremities - are assessed for erythema, induration, and desquamation. The severity of each sign is assessed using a 5-point scale:
0 = No symptoms
1 = Slight
2 = Moderate
3 = Marked
4 = Very marked
The area affected by psoriasis within a given anatomic site is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of psoriatic involvement from 0-6.
Total scale 0 = best and 72 = worst"|112, 140 and 168 days|The analysis was intention to treat (ITT) and the imputation technique was Non-Responder(NRI).||Participants|||Number
761511|NCT00640393|Primary|Number of Participants Attaining a 90 Percent Reduction in PASI From Baseline (PASI 90) - ITT|"Four anatomic sites - head, upper extremities, trunk and lower extremities - are assessed for erythema, induration, and desquamation. The severity of each sign is assessed using a 5-point scale:
0 = No symptoms
1 = Slight
2 = Moderate
3 = Marked
4 = Very marked
The area affected by psoriasis within a given anatomic site is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of psoriatic involvement from 0-6.
Total scale 0 = best and 72 = worst"|112 and 140 days|The analysis was intention to treat (ITT) and the imputation technique was Non-Responder(NRI).||Participants|||Number
761512|NCT00640510|Secondary|Number of Participants With Scores of 4 to 7 in the Agitation-Calmness Evaluation Scale (ACES) at Each Timepoint|The ACES differentiates agitation, calmness, and sleep-state, using a 9-point scale: 1 (Marked Agitation) to 9 (Unarousable). Scores of 4 (Normal) to 7 (Marked Calmness) were used for this outcome measure.|30 min, 60 min, 90 min and 2 hours post first IM injection|Number of patients having the measure at post-baseline. Last Observation Carried Forward.||participants|||Number
761513|NCT00640510|Secondary|Number of Responders at 2 Hours After First Intramuscular (IM) Injection|A responder was defined ast he patient with ≥ 40% decrease in the PANSS-EC total score at 2 hours after the first IM injection in comparison with baseline. (See outcome measure 1 for description of PANSS-EC).|2 hours post first IM injection|Number of patients having the measures both at baseline and post-baseline. Last Observation Carried Forward.||participants|||Number
761514|NCT00640510|Secondary|Change From Baseline to Each Timepoint in Positive and Negative Syndrome Scale-Excited Component (PANSS-EC)|Measures excitability and consists of the following 5 items from the PANSS: Excitement, Hostility, Tension, Uncooperativeness, and Poor Impulse Control. Each item is rated on a scale from 1 (Absent) to 7 (Extreme). The sum of the 5 items is defined as the PANSS-EC total score which ranges from 5 to 35.|15 min, 30 min, 60 min, 90 min post first IM injection|Number of patients having the measure both at baseline and post-baseline. Last Observation Carried Forward.||units on a scale||Standard Deviation|Mean
761515|NCT00640510|Primary|Change From Baseline to 2 Hours Post the First Intramuscular (IM) Injection in Positive and Negative Syndrome Scale-Excited Component (PANSS-EC)|Measures excitability and consists of the following 5 items from the PANSS: Excitement, Hostility, Tension, Uncooperativeness, and Poor Impulse Control. Each item is rated on a scale from 1 (Absent) to 7 (Extreme). The sum of the 5 items is defined as the PANSS-EC total score which ranges from 5 to 35.|2 hours post first intramuscular (IM) injection|Number of randomized patients having the measures both at baseline and post-baseline. Last Observation Carried Forward.||units on a scale||Standard Deviation|Mean
761519|NCT00640562|Secondary|Concomitant Use of Antidepressive Drugs From Baseline to Week 12|Number of concomitant users of antidepressive drugs during the study; the number of participants analyzed refers to safety population, that is to overall participants excluding 6 participants who did not assume any study drug administration|12 week from baseline to last visi|||Participants|||Number
761520|NCT00640562|Secondary|Change From Baseline in the Simpson Angus Scale (SAS) Total Score to Week 12 as an Indication of Neurological Side Effects Section|"Extrapyramidal Side Effects (EPS) will be assessed using the Simpson-Angus Scale (SAS; Simpson GN et al 1970) . The CRF is source data for these assessments and day 0 is considered as baseline.
The SAS scale, containing 10 items, will be rated on a five-point scale where 0 is normal and 4 are severe symptoms. Min score =0, max score 40
Change from start of treatment (day 0) will be calculated as the visit score minus the score at start of treatment for each of the neurological assessments."|12 weeks from baseline to last visit|||score on scale||Standard Deviation|Mean
761521|NCT00640562|Secondary|Change From Baseline to Week 12 of Drug Attitude Inventory 10 Item Scale (DAI 10) Score|These items are presented as self-report statements with which the patient agrees or disagrees. Each response is scored as +1 if correct or –1 if incorrect. The final score is the grand total of the positive and negative points. A positive score means a positive subjective response. A negative total score means a negative subjective response|12 week from baseline to last visit|||score on scale||Standard Deviation|Least Squares Mean
761522|NCT00640562|Secondary|CGI- Global Improvement Mean Score at Week 12|The CGI-S subset ranges from 1 to 7 such that a score of 1 indicates “normal, not at all ill”, while a score of 7 indicates “among the most extremely ill of patients”. The change from start of treatment (baseline V2) in the Severity of Illness will be calculated by subtracting the score at start of treatment (baseline V2) from the following visits|12week: descriptive statistic of CGI by visit and treatment|||score on a scale||Standard Deviation|Mean
761523|NCT00640562|Secondary|- Change From Baseline to Week 12 of Clinical Global Impression (CGI- Severity of Illness) Score|The CGI-S subset ranges from 1 to 7 such that a score of 1 indicates “normal, not at all ill”, while a score of 7 indicates “among the most extremely ill of patients”. The change from start of treatment (baseline V2) in the Severity of Illness will be calculated by subtracting the score at start of treatment (baseline V2) from the following visits|12 weeks from baseline to last visit|||Score on scale||Standard Deviation|Least Squares Mean
761524|NCT00640562|Secondary|Change From Baseline to Week 12 of PANSS Score|30-item scale where each symptom is rated on a severity ranging from 1-7. Symptoms are categorized into 7 items referring to positive, 7 items referring to negative and 16 general psychotic. Total score range 30- 210, higher values represent worse outcome. Number of participants analyzed refers to valid for efficacy per protocol population.|12 weeks from baseline to last visit|||score on scale||Standard Deviation|Mean
761525|NCT00640562|Secondary|Change From Baseline to Week 12 of HAM-D Score|21-item scale for depression. Symptoms are rated finely (on a 5-point scale: absent; doubtful or trivial; mild: moderate severe) or coarsely (on a 3- point scale: absent; doubtful or mild; obvious, distinct, or severe).Total score range 0- 66, higher values represent worse outcome.Number of participants refers to valid for efficacy per protocol. Change:total score at week 12 minus total score at baseline.|12 weeks from baseline to last visit|||Score on scale||Standard Deviation|Mean
761526|NCT00640562|Primary|Change From Baseline to Week 12 of Calgary Depression Scale for Schizophrenia (CDSS) Score.|"The CDSS scale is used to assess the level of depression in schizophrenia and to estimate the severity of depressive symptoms.
CDSS has 9 items rated on four–point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Anchor point descriptions are provided to aid differentiation between each item score. The first eight items are rated on basis of patients’ responses to questions; the 9 item is based on clinician’s assessment.
The sum score is derived by adding the point score of all items (from 0 to 27 points); total score 4-5 is considered for minor depression and 6-7 score for major depression."|12 week from baseline to last visit|||Score on a scale||Standard Deviation|Least Squares Mean
761527|NCT00640601|Secondary|Change in Barnes Akathisia Rating Scale (BARS)|The Percentage of patients with change in BARS score was calculated. The BARS is a 4 item scale that is rating Extrapyramidal symptoms (EPS) on a 4-point scale for the first three questions and on a 6-point scale for the last question. 0=normal and a higher value represents more pronounced symptoms of EPS. BARS has a focus on the akathisia symptoms of EPS.|Baseline to 24 weeks|The intention to treat (ITT) population (i.e., all subjects who received at least one dose of the study medication) comprised the population for the analysis (n=295)||percentage of subjects|||Number
761528|NCT00640601|Secondary|Change in Safety Measure: Simpson-Angus Scale (SAS)|The Percentage of patients with change in Simpson-Angus Scale (SAS)was calculated. This is a 10 item scale that is rated on a five-point scale where 0=normal and 4=severe symptoms of Extrapyramidal symptoms (EPS) with a focus on parkinsonian symptoms of EPS.|Baseline to 24 weeks|The intention to treat (ITT) population (i.e., all subjects who received at least one dose of the study medication) comprised the population for the analysis (n=295)||Percentage of subjects|||Number
761529|NCT00640601|Secondary|Change in Social and Occupational Functioning Assessment Scale (SOFAS)|Change in SOFAS score. The SOFAS is a 100 point single item scale that rates functioning of a patient. The scale values range from 1=most impaired to 100=healthiest individual. The scale also includes a rating point of 0=missing information.|Baseline to 24 weeks|The intention to treat (ITT) population (i.e., all subjects who received at least one dose of the study medication) comprised the population for the analysis (n=295)||units on a scale||Standard Deviation|Mean
761530|NCT00640601|Secondary|Change in Clinical Global Impression-Improvement (CGI-I) Scale|Change in CGI-I scale. This scale is the second part of the CGI scale that is scored at Visit 3 to week 24 to observe the patient’s change from start of treatment. The scores for the CGI-I subset ranges from 1 to 7 (1=very much improved, 7=very much worse and a score of 4 indicates no change.)|Day 7 - week 24|The intention to treat (ITT) population (i.e., all subjects who received at least one dose of the study medication) comprised the population for the analysis (n=295)||units on a scale||Standard Deviation|Mean
761545|NCT00640614|Primary|Diagnostic Performance: Sensitivity and Specificity: Methyldibromo-glutaronitrile|The number of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen|Visit 5: 21 days after patch application|||percentage of agreement||95% Confidence Interval|Number
762022|NCT00645853|Secondary|Alanine Transaminase (ALAT): Number of Patients With ALAT>=3xULN, Post Baseline|ULN=Upper limit of Normal|From baseline to Follow up|||Participants|||Number
761531|NCT00640601|Secondary|Change in Clinical Global Impression-Severity (CGI-S) Scale|The CGI-S assesses severity of illness which is scored to rate the patient’s current clinical state at start of treatment. The scores range from 1 to 7, where 1= normal, not at all ill, while a score of 7=among the most extremely ill of subjects. The change from start of treatment in the severity of illness is calculated by subtracting the score at start of treatment from the visit score. Alleviation of symptom severity will be indicated by a negative change score.|Baseline to 24 weeks|The intention to treat (ITT) population (i.e., all subjects who received at least one dose of the study medication) comprised the population for the analysis (n=295)||units on a scale||Standard Deviation|Mean
761532|NCT00640601|Secondary|Change in Global Assessment Scale (GAS)|Change in GAS score. The GAS is a 100-point single item scale that rates patient’s functioning on a hypothetical continuum of mental health to mental illness. The scale values range from 1 to 100 (1=most impaired, 100=healthiest).|Baseline to 24 weeks|The intention to treat (ITT) population (i.e., all subjects who received at least one dose of the study medication) comprised the population for the analysis (n=295)||units on a scale||Standard Deviation|Mean
761533|NCT00640601|Secondary|Change in Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Negative Scale Score|Change in negative subscale of PANSS. This subscale calculates the sum of the scores in PANSS items N1-N7. (1=absent symptoms, 7=extreme symptoms). Maximum total score: 49, minimum total score: 7.|Baseline to 24 weeks|The intention to treat (ITT) population (i.e., all subjects who received at least one dose of the study medication) comprised the population for the analysis (n=295)||units on a scale||Standard Deviation|Mean
761534|NCT00640601|Secondary|Change in Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Positive Scale Score|Change in positive subscale of PANSS. This subscale calculates the sum of the scores in PANSS items P1-P7. (1=absent symptoms, 7=extreme symptoms). Maximum total score: 49, minimum total score: 7.|Baseline to 24 weeks|The intention to treat (ITT) population (i.e., all subjects who received at least one dose of the study medication) comprised the population for the analysis (n=295)||units on a scale||Standard Deviation|Mean
761535|NCT00640601|Secondary|Change in Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Total Score|Change in PANSS total score which includes Positive, Negative and General psychopathology. The PANSS is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7, where 1=absent, 7=extreme). Maximum total score: 210, minimum total score is 30. Seven items are referring to positive symptoms (P1-7), seven items to negative symptoms (N1-7) and 16 items to general psychopathology (G1-16). The assessment prior to start of treatment is considered the baseline assessment.|Baseline to 24 weeks|The intention to treat (ITT) population (i.e., all subjects who received at least one dose of the study medication) comprised the population for the analysis (n=295)||units on a scale||Standard Deviation|Mean
761536|NCT00640601|Secondary|Change in Clinical Global Impression-Clinical Benefit (CGI-CB) Score|Numerical change in CGI-CB score. The CGI-CB scale is used to evaluate investigator’s global weighted impression of efficacy and interference of adverse events (AEs) from enrolment to every visit. The score ranges from 1 to 10. The lower the score the better the outcome, e.g.: a score of 1 means that there is marked therapeutic effect with no burden of AEs. A score of 10 signifies that the burden of AEs outweighs the therapeutic effect, or no therapeutic effect with high burden of AEs. A change score for each subject will be calculated by subtracting the baseline score from the visit score.|Baseline to 24 weeks|The intention to treat (ITT) population (i.e., all subjects who received at least one dose of the study medication) comprised the population for the analysis (n=295)||units on a scale||Standard Deviation|Mean
761537|NCT00640601|Primary|Percentage of Subjects With Improved Clinical Benefit From Assessment of Clinical Global Impression-Clinical Benefit (CGI-CB) Scale From Baseline to Week 24 or End of Study|Proportional change in CGI-CB score The CGI-CB scale is used to evaluate investigator’s global weighted impression of efficacy and interference of adverse events (AEs) from enrolment to every visit. The score ranges from 1 to 10. The lower the score the better the outcome, e.g.: a score of 1 means that there is marked therapeutic effect with no burden of AEs. A score of 10 signifies that the burden of AEs outweighs the therapeutic effect, or no therapeutic effect with high burden of AEs. A change score for each subject will be calculated by subtracting the baseline score from the visit score.|Baseline to 24 weeks (or end of study)|The intention to treat (ITT) population (i.e., all subjects who received at least one dose of the study medication) comprised the population for the analysis (n=295)||Percentage of Participants||95% Confidence Interval|Mean
761538|NCT00640614|Secondary|Persistent Reactions: All T.R.U.E. Test Allergens|Number of Subjects who exhibited Persistent Reactions (reactions that initially occur at 2-4 days after application and persist through 7-21 days after application)|initially occur 2-4 days after application and last through 7-21days after patch application|||participants|||Number
761539|NCT00640614|Secondary|Late Reactions: All T.R.U.E. Test Allergens|Number of subjects who exhibited Late Reactions (reactions that occur at 7-10 days after application).|7-10 days after patch application|||participants|||Number
761540|NCT00640614|Secondary|Safety Evaluations: All T.R.U.E. Test Allergens|Safety Evaluations: Number of participants who experienced Tape Irritation, Itching or Burning and measure of how well patches adhered to the skin.|Day 2: 48 hours after application|NOTE: These secondary measurements apply to the entire subject population and were not separated by 'sensitive' or 'consecutive' subjects.||participants|||Number
761541|NCT00640614|Primary|Diagnostic Performance: Sensitivity and Specificity: Bronopol|The number of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen|Visit 5: 21 days after patch application|||percentage of agreement||95% Confidence Interval|Number
761542|NCT00640614|Primary|Diagnostic Performance: Sensitivity and Specificity: Disperse Blue|The number of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen|Visit 5: 21 days after patch application|||percentage of agreement||95% Confidence Interval|Number
761543|NCT00640614|Primary|Diagnostic Performance: Sensitivity and Specificity: Parthenolide|The number of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen|Visit 5: 21 days after patch application|||percentage of agreement||95% Confidence Interval|Number
761544|NCT00640614|Primary|Diagnostic Performance: Sensitivity and Specificity: Bacitracin|The number of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen|Visit 5: 21 days after patch application|||percentage of agreement||95% Confidence Interval|Number
761546|NCT00640614|Primary|Diagnostic Performance: Sensitivity and Specificity: Hydrocortisone-17-butyrate|The number of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen|Visit 5: 21 days after patch application|||percentage of agreement||95% Confidence Interval|Number
761547|NCT00640614|Primary|Diagnostic Performance: Sensitivity and Specificity: Gold Sodium Thiosulfate|Number of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen|Visit 5: 21 days after patch application|||percentage of agreement||95% Confidence Interval|Number
761548|NCT00640614|Primary|Diagnostic Performance: Concordance|Concordance: Number of subjects who responded positively to T.R.U.E. Test allergen bronopol and the reference allergen.|Visit 5: 21 days after patch application|Subjects with past positive test results to bronopol||percentage of concordant responses||95% Confidence Interval|Number
761549|NCT00640614|Primary|Diagnostic Performance: Concordance|Concordance:Number of subjects who responded positively to T.R.U.E. Test allergen disperse blue and the reference allergen.|Visit 5: 21 days after patch application|Subjects with past positive patch test results to disperse blue||percentage of concordant responses||95% Confidence Interval|Number
761550|NCT00640614|Primary|Diagnostic Performance: Concordance|Concordance: Number of subjects who responded positively to TRUE Test allergen parthenolide and the reference allergen.|Visit 5: 21 days after patch application|Subjects with past positive patch test results to parthenolide||percentage of concordant responses||95% Confidence Interval|Number
761551|NCT00640614|Primary|Diagnostic Performance: Concordance|Concordance: Number of subjects who responded positively to TRUE Test allergen bacitracin and the reference allergen.|Visit 5: 21 days after patch application|Subjects with past positive patch test results to bacitracin||percentage of concordant responses||95% Confidence Interval|Number
761552|NCT00640614|Primary|Diagnostic Performance: Concordance|Concordance: Number of subjects who responded positively to T.R.U.E. Test allergen methyldibromo-glutaronitrile and the reference allergen.|Visit 5: 21 days after patch application|Subjects with past positive patch test results to methyldibromo-glutaronitrile||percentage of concordant responses||95% Confidence Interval|Number
761553|NCT00640614|Primary|Diagnostic Performance: Concordance|Concordance: Number of subjects who responded positively to T.R.U.E. Test allergen hydrocortisone-17-butyrate and the reference allergen|Visit 5: 21 days after patch application|Subjects with past positive patch test results to hydrocortizone-17-butyrate||percentage of concordant responses||95% Confidence Interval|Number
761554|NCT00640614|Primary|Diagnostic Performance: Concordance|Concordance: Number of subjects who responded positively to T.R.U.E. Test allergen gold sodium thiosulfate and the reference allergen|Visit 5: 21 days after patch application|Subjects with past positive patch test results to gold sodium thiosulfate||percentage of concordant responses||95% Confidence Interval|Number
761555|NCT00640822|Secondary|Patients With Rebound During the Study||Week 8-16||||||
761556|NCT00640822|Secondary|Patients With Relapse During the Study and Time to Relapse||Week 8-16||||||
761557|NCT00640822|Secondary|Total Sign Score of the Intertriginous Areas||Week 8||||||
761558|NCT00640822|Secondary|Overall Disease Severity of the Intertriginous Areas According to the Investigator's Assessment||Week 8||||||
761559|NCT00640822|Secondary|Severity Scores for Redness, Thickness and Scaliness of the Face||Week 8||||||
761560|NCT00640822|Secondary|Total Sign Score of the Face||Week 8||||||
761561|NCT00640822|Secondary|Overall Disease Severity of the Face According to the Investigator's Assessment||Week 4||||||
761562|NCT00640822|Primary|Subjects With Controlled Disease According to the Investigator Assessment of the Face at Week 8||Week 8|||Participants|||Number
761563|NCT00640835|Primary|Number of Subjects With Mild, Moderate or Severe Treatment-emergent Adverse Events Associated With the Oral Cavity|Safety and tolerability were evaluated during the 12-week Treatment Phase by oral cavity examination and assessment.|12 weeks|The population was defined as all subjects who received at least a single dose of study drug and was the only population considered in the analysis plan. Missing data values were not imputed.||Participants|||Number
761564|NCT00640835|Primary|Number of Subjects With Treatment-emergent Adverse Events Associated With the Oral Cavity.|"Safety and tolerability were evaluated during the 12-week Treatment Phase by oral cavity examination and assessment. Oral mucosa was graded as follows:
Grade 0: Normal mucosa Grade 1: Localized mucosal erythema and/or irritation without ulceration Grade 2: Erythema and/or irritation and induration without ulceration Grade 3: Ulceration, with or without any other combination of signs"|12 weeks|The population was defined as all subjects who received at least a single dose of study drug and was the only population considered in the analysis plan. Missing data values were not imputed.||Participants|||Number
761565|NCT00640926|Other Pre-specified|Per Patient Microbiological Response of Eradicated in the Microbiologically Evaluable (ME) Population at Test of Cure (TOC)|The number of ME patients (defined as those CE patients with evidence of 1 or more of 7 key CAP pathogens: S. pneumoniae, H. influenzae, M. catarrhalis, M. pneumoniae, C. pneumoniae, and L. pneumophila) with a microbiologic response of eradicated, i.e. either documented eradication of the baseline pathogen(s), or presumed eradication in the setting of clinical cure with no material to culture.|Study Days 14-38|Microbiologically evaluable (ME) patients were defined as CE patients with evidence of 1 or more of 7 key CAP pathogens: S. pneumoniae, H. influenzae, M. catarrhalis, M. pneumoniae, C. pneumoniae, and L. pneumophila.||Participants|||Number
761566|NCT00640926|Primary|Clinical Cure in the Clinically Evaluable (CE) Population at Test of Cure (TOC)|Patients were considered cured if all systemic signs and symptoms of CAP present at screening were improved or resolved and no further antibiotic therapy was necessary. In addition, the follow-up chest X-ray was to be either stable or improved.|Study days 14-38|Clinically evaluable patients were those that had a diagnosis of CAP, as defined in the inclusion criteria; who received an appropriate course of therapy; who did not receive any other concomitant antibiotics, and who returned for a TOC visit in the appropriate time frame.||Participants|||Number
761567|NCT00640978|Primary|Number of Participants Surviving at 6 Months|Overall survival (OS) at 6 months in participants receiving a combination of Erlotinib and RAD001 who have received previous treatment for advanced pancreatic cancer. OS at 6 months is number of participants alive at 6 months.|6 months|||Participants|||Number
762023|NCT00645853|Primary|Bleeding: Number of Patients With Any Bleeding Event, During Treatment Period|Participants|154-711 days on treatment|||Participants|||Number
761568|NCT00641043|Secondary|Percentage of Patients Who Have an HbA1c Lowering by 0.5% at Week 24|The percentage of patients with an HbA1c reduction from baseline greater than 0.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c reduction less than 0.5%.|Baseline and Week 24|The Full Analysis Set (FAS) included all patients with a baseline and at least one on treatment HbA1c measurement available. Non-completers were considered as failure imputation (NCF).||percentage of patients|||Number
761569|NCT00641043|Secondary|Percentage of Patients With HbA1c<6.5% at Week 24|The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 6.5%|Baseline and week 24|This population includes the Full Analysis Set (FAS). Non-completers were considered as failure imputation (NCF).||percentage of patients|||Number
761570|NCT00641043|Secondary|Percentage of Patients With HbA1c <6.5% at Week 24|The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 6.5%. Only patients with baseline HbA1c >= 6.5%|Baseline and Week 24|This population includes the FAS with baseline HbA1c >= 6.5%. Non-completers were considered as failure imputation (NCF).||percentage of patients|||Number
761571|NCT00641043|Secondary|Percentage of Patients With HbA1c<7.0 at Week 24|The percentage of patients with an HbA1c value below 7% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 7%.|Baseline and Week 24|This population includes the Full Analysis Set (FAS). Non-completers were considered as failure imputation (NCF).||percentage of patients|||Number
761572|NCT00641043|Secondary|Percentage of Patients With HbA1c <7.0% at Week 24|The percentage of patients with an HbA1c value below 7% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 7%. Only patients with baseline HbA1c >= 7%|Baseline and Week 24|This population includes the FAS with baseline HbA1c >= 7.0%. Non-completers were considered as failure imputation (NCF).||percentage of patients|||Number
761573|NCT00641043|Secondary|FPG Change From Baseline to Week 18|This change from baseline reflects the Week 18 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetes medication.|Baseline and week 18|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.||mg/dL||Standard Error|Mean
761574|NCT00641043|Secondary|FPG Change From Baseline to Week 12|This change from baseline reflects the Week 12 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 12|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.||mg/dL||Standard Error|Mean
761575|NCT00641043|Secondary|FPG Change From Baseline to Week 6|This change from baseline reflects the Week 6 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 6|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.||mg/dL||Standard Error|Mean
761576|NCT00641043|Secondary|FPG Change From Baseline to Week 24|This change from baseline reflects the Week 24 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 24|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.||mg/dL||Standard Error|Mean
761577|NCT00641043|Secondary|HbA1c Change From Baseline to Week 18|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 18|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||Percent||Standard Error|Mean
761578|NCT00641043|Secondary|HbA1c Change From Baseline to Week 12|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 12|The Full Analysis Set (FAS) included all randomised and treated patients with a baseline and at least one on treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||Percent||Standard Error|Mean
761579|NCT00641043|Secondary|HbA1c Change From Baseline to Week 6|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 6 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 6|The Full Analysis Set (FAS) included all randomised and treated patients with a baseline and at least one on treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||Percent||Standard Error|Mean
761580|NCT00641043|Primary|HbA1c Change From Baseline to Week 24|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 24|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||Percent||Standard Error|Mean
761581|NCT00641056|Secondary|Assessment on Event Rate of Treatment-emergent Hypoglycemic Episodes|Major hypoglycemia: any episode with symptoms consistent with hypoglycemia that resulted in loss of consciousness or seizure with prompt recovery in response to administration of glucagon or glucose or documented hypoglycemia (blood glucose <3.0 mmol/L [54 mg/dL]) and required the assistance of another person. Minor hypoglycemia: any time a patient felt that he or she was experiencing a sign or symptom of hypoglycemia that was self-treated or resolved on its own and had a blood glucose level <3.0 mmol/L (54 mg/dL) and not classified as major hypoglycemia.|Baseline to Week 26|ITT Population.||rate per subject-year||Standard Error|Mean
761851|NCT00644059|Secondary|Number of Subjects With Local and Systemic Reactions for Egg and Cell Derived Inactivated Novel Swine Origin A/H1N1 Subunit Influenza Vaccines After Each Vaccination for All Seasons||7 days post-vaccination|Adequate data was not available to conduct this analysis.|||||
761582|NCT00641056|Secondary|Change in Blood Pressure From Baseline to Week 26|Change in Systolic Blood Pressure (mmHg) and Diastolic Blood Pressure (mmHg) from Baseline to Week 26|Baseline, Week 26|ITT Population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.||mmHg||Standard Deviation|Mean
761583|NCT00641056|Secondary|Ratio of Triglycerides at Week 26 to Baseline|Ratio of Triglycerides (measured in mmol/L) at Week 26 to Baseline. Log (Postbaseline Triglycerides) - log (Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline.|Baseline, Week 26|ITT Population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.||ratio||Standard Error|Least Squares Mean
761584|NCT00641056|Secondary|Change in High-density Lipoprotein Cholesterol (HDL) From Baseline to Week 26|Change in HDL (mmol/L) from Baseline to Week 26|Baseline, Week 26|ITT Population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.||mmol/L||Standard Error|Least Squares Mean
761585|NCT00641056|Secondary|Change in Total Cholesterol From Baseline to Week 26|Change in Total Cholesterol (mmol/L) from Baseline to Week 26|Baseline, Week 26|ITT Population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.||mmol/L||Standard Error|Least Squares Mean
761586|NCT00641056|Secondary|Change in Body Weight (BW) From Baseline to Week 26|Change in BW (kg) from Baseline to Week 26|Baseline, Week 26|ITT Population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.||kg||Standard Error|Least Squares Mean
761587|NCT00641056|Secondary|Change in Fasting Serum Glucose (FSG) From Baseline to Week 26|Change in FSG (mmol/L) from Baseline to Week 26|Baseline, Week 26|ITT Population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.||mmol/L||Standard Error|Least Squares Mean
761588|NCT00641056|Secondary|Percentage of Patients Achieving HbA1c <=6.5% at Week 26|Percentage of patients achieving HbA1c <=6.5% at Week 26 (for patients with HbA1c >6.5% at baseline)|Baseline, Week 26|ITT Population. Only patients with baseline HbA1c > 6.5% were included in calculation. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.||percentage of patients|||Number
761589|NCT00641056|Secondary|Percentage of Patients Achieving HbA1c <=7.0% at Week 26|Percentage of patients achieving HbA1c <=7.0% at Week 26 (for patients with HbA1c >7% at baseline)|Baseline, Week 26|ITT Population. Only patients with baseline HbA1c > 7% were included in calculation. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.||percentage of patients|||Number
761590|NCT00641056|Primary|Change in HbA1c From Baseline to Week 26|Change in HbA1c from baseline to Week 26|Baseline, Week 26|ITT Population: All randomized patients who had taken at least one dose of study drug. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.||percentage of total hemoglobin||Standard Error|Least Squares Mean
761591|NCT00641147|Other Pre-specified|Change in Akt Phosphorylation Levels||Baseline up to 12 months||||||
761592|NCT00641147|Other Pre-specified|Activation of NFKB (Nuclear Factor Kappa-light-chain-enhancer of Activated B Cells) Pathway||Baseline to 12 months||||||
761593|NCT00641147|Other Pre-specified|Change in Vascular Density||Baseline up to 12 months||||||
761594|NCT00641147|Other Pre-specified|Number of Patients Failing Study.|Patients withdrawn from study due to increasing polyp burden and/or advancing histology.|Up to 16 months.|||Participants|||Count of Participants
761595|NCT00641147|Other Pre-specified|Change in Mucosal Prostaglandin Levels.||Baseline to up to 12 months.|The outcome data were not collected and the outcome will never be analyzed.|||||
761596|NCT00641147|Other Pre-specified|Change in Mucosal Leukotriene Levels.||Baseline to up to 12 months.|The outcome data were not collected and the outcome will never be analyzed.|||||
761597|NCT00641147|Other Pre-specified|Change in Mucosal DNA Methylation Levels.||Baseline to up to 12 months|The outcome data were not collected and the outcome will never be analyzed.|||||
761598|NCT00641147|Secondary|Change in Apoptosis Index Levels|Change in apoptosis index levels at 8 months by assessing cleaved Caspase-3 measurement|8 months|Specimens for analysis were only available on 7 curcumin and 10 placebo participants.||apoptotic rate||Standard Deviation|Mean
761599|NCT00641147|Secondary|Change in Ki-67 Anti-proliferative Cell Nuclear Antibody Index Levels|Change in cellular proliferation rate was measured by assessment of Ki-67 anti-proliferative cell nuclear antibody index levels at 8 months|Baseline up to 8 months|Specimens for analysis were only available on 7 curcumin and 10 placebo participants.||labeled cells/crypt epithelial cells||Standard Deviation|Mean
761600|NCT00641147|Secondary|Change in Spermine Oxidase (SMOX)|Change in SMOX mean activity level at 8 months compared to baseline (time 0)|Baseline and 8months|||pmol H2O2 per min per mg protein||Standard Deviation|Mean
761601|NCT00641147|Secondary|Change in Spermidine/Spermine N-1 Acetyl Transferase (SSAT)|Change in SSAT mean activity level at 8 months compared to baseline (time 0)|Baseline and 8 months|||pmol/acetylspermidine/mg protein/min||Standard Deviation|Mean
761602|NCT00641147|Secondary|Change in Micro RNA 124-U6 (miR124-U6)|Change in MicroRNA mean activity level at 8 months compared to baseline (time 0)|Baseline and 8 months|||qRT-PCR relative to U6 snRNA||Standard Deviation|Mean
761603|NCT00641147|Secondary|Change in Total Polyamines Levels|Polyamine mean level changes (expressed as pg/mg protein) at month 8-baseline|Baseline and 8 months|||pg/mg protein||Standard Deviation|Mean
761604|NCT00641147|Secondary|Change in Ornithine Decarboxylase (ODC) Activity Levels|Change in ODC mean activity levels (expressed as nmol of activity/mg of mucosal tissue/hr) at 8 months compared to baseline (time 0)|Baseline and 8 months|||nmol/mg/hr||Standard Deviation|Mean
761605|NCT00641147|Secondary|Medication Compliance|Medication compliance of the participant= number of capsules taken divided by the number of capsules prescribed as determined by pill count and described as a percentage per participant. Then the compliance of each participant in the assigned group (curcumin or placebo) was averaged together to obtain the medication compliance rate of that group.|Up to 12 months|||percentage of total compliance||Full Range|Median
761606|NCT00641147|Secondary|Number of Participants With Grade >=2 Adverse Events|"Events were graded as follows:
Grade 0= no adverse event or within normal limits; Grade 1= mild adverse event (causing no limitations of usual activity); Grade 2= moderate adverse event (causing some limitation of activity); Grade 3= severe adverse event (severe and undesirable; causing inability to carry out usual activities; Grade 4= life threatening or disabling adverse event; Grade 5= fatal adverse event."|Up to 12 months|||Participants|||Count of Participants
761607|NCT00641147|Secondary|Number of Participants With a Decrease in Polyp Burden at 12 Months|The polyp burden as evaluated by video tape review. Polyp burden at 12 months compared to time 0 for each participant and counting participants with decrease in polyp burden at 12 months.|12 months|||Participants|||Count of Participants
761608|NCT00641147|Secondary|Mean Polyp Size in mm|Mean size of the 5 largest polyps|Up to 12 months|||mm||95% Confidence Interval|Mean
761609|NCT00641147|Primary|Polyp Number|Average number of polyps in the placebo arm at the end of the study is compared to the average in the curcumin arm|Up to 12 months|||polyps||95% Confidence Interval|Mean
761610|NCT00635219|Secondary|Change From Baseline in ASEX Total Score After 8 Weeks of Treatment|The Arizona Sexual Experience Scale (ASEX) is a 5-item, patient self-rated scale that evaluates a patient’s recent sexual experience. Patients are asked to assess their own experience over the last week (for example, “How strong is your sex drive?”, “Are your orgasms satisfying?”) and respond on a 6-point scale for each item. The ASEX is used to identify individuals with sexual dysfunction. Possible total score ranges from 5 to 30, with the higher score indicating more patient sexual dysfunction. A negative change indicates a lower sexual dysfunction.|Baseline and Week 8|FAS; LOCF; ANCOVA||units on a scale||Standard Error|Mean
761611|NCT00635219|Secondary|Change From Baseline in CGI-S Score After 8 Weeks of Treatment|The Clinical Global Impression - Severity of Illness (CGI-S) is a 7-point scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The investigator should use his/her total clinical experience with this patient population to judge how mentally ill the patient is at the time of rating.|Baseline and Week 8|FAS; LOCF; ANCOVA||units on a scale||Standard Error|Mean
761612|NCT00635219|Secondary|Change From Baseline in HAM-A Total Score After 8 Weeks of Treatment|The Hamilton Anxiety Rating Scale (HAM-A) consists of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behaviour at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic, and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total score from 0 to 56. The higher the score, the more severe.|Baseline and Week 8|FAS; LOCF; ANCOVA||units on a scale||Standard Error|Mean
761613|NCT00635219|Secondary|Proportion of Remitters at Week 8 (Remission Defined as a MADRS Total Score <=10)||Week 8|FAS; LOCF; Logistic Regression||percentage of patients|||Number
761614|NCT00635219|Secondary|Change From Baseline in SDS Total Score After 8 Weeks of Treatment|The Sheehan Disability Scale (SDS) comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). The higher the score, the more severe.|Baseline and Week 8|SDS is a patient-reported outcome. The SDS Total Score is the sum of work, social life, or leisure activities, and home life or family responsibilities. FAS; LOCF; ANCOVA||units on a scale||Standard Error|Mean
761615|NCT00635219|Secondary|Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment in Patients With Baseline HAM-A Total Score >=20||Baseline and Week 8|Patients With Baseline HAM-A Total Score >=20: FAS; LOCF; ANCOVA||units on a scale||Standard Error|Mean
761616|NCT00635219|Secondary|Change in Clinical Status Using CGI-I Score at Week 8|The Clinical Global Impression - Global Improvement (CGI-I) is a 7-point scale rated from 1 (very much improved) to 7 (very much worse). The investigator rated the patient's overall improvement relative to baseline, whether or not, in the opinion of the investigator, this was entirely due to the drug treatment.|Week 8|FAS; LOCF; ANCOVA||units on a scale||Standard Error|Mean
761617|NCT00635219|Secondary|Proportion of Responders at Week 8 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline)||Week 8|FAS; LOCF; Logistic Regression||percentage of patients|||Number
761618|NCT00635219|Secondary|Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment|The Hamilton Depression Scale - 24 Items (HAM-D-24) measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 76. The higher the score, the more severe.|Baseline and Week 8|FAS; LOCF; ANCOVA||units on a scale||Standard Error|Mean
761619|NCT00635219|Primary|Change From Baseline in MADRS Total Score After 8 Weeks of Treatment|The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe.|Baseline and Week 8|Full-analysis set (FAS) - all patients in the all-patients-treated set (APTS) who had at least one valid post-baseline assessment of the primary efficacy variable; last observation carried forward (LOCF); analysis of covariance (ANCOVA)||units on a scale||Standard Error|Mean
761620|NCT00635232|Secondary|The Percentage of Patients Treated With Each Dose of PS433540 Who Achieved Blood Pressure Control, Defined as <140/90 mmHg, After 12 Weeks of Treatment.||12 weeks|Full analysis set (LOCF)||participants|||Number
761621|NCT00635232|Secondary|Change From Baseline in Mean Seated Diastolic Blood Pressure (DBP) Following 12 Weeks of Treatment With PS433540 200 mg, 400 mg, 800 mg and Placebo.||12 weeks|||mm Hg||Standard Deviation|Mean
761622|NCT00635232|Primary|Change From Baseline in Mean Seated Systolic Blood Pressure (SBP) Following 12 Weeks of Treatment With PS433540 200 mg, 400 mg, 800 mg and Placebo.||12 weeks|The primary efficacy population was the Full Analysys Set (FAS) population= all randomized subjects who took at least one dose of the assigned study drug and had both baseline and post-baseline mean seated SBP. Both LOCF and observed-data set approach were performed.||mm Hg||Standard Deviation|Mean
792646|NCT00887978|Post-Hoc|6-minute Walk Distance by Background PAH Therapy: PDE-5i Only||16 weeks|Subjects receiving only a PDE-5i at Baseline||meters||Inter-Quartile Range|Median
761623|NCT00635349|Secondary|Number of Participants With Categorical Tenderness|Tenderness was assessed by using a 4-point scale 0 to 3 where, 0= no tenderness, 1= complaint of tenderness, 2=complaint of tenderness with wincing (CTW), and 3=wincing and attempt to withdraw.|Day 29, Day 57 and Day 85|FAS population included all randomly assigned participants excluding those who violated the major eligibility criteria or had no data at all after randomization. Here 'n' signifies number of participants evaluable at each time point for each arm respectively.||participants|||Number
761624|NCT00635349|Secondary|Number of Participants With Categorical Swelling|Swelling was assessed by using a 4-point scale ranging from 0 to 3 where, 0=no swelling, 1=presence of cross fluctuation of fluid (PCFF), 2=patellar ballotment, and 3=swelling that distort the joint contours (SDJC).|Day 29, Day 57 and Day 85|FAS population included all randomly assigned participants excluding those who violated the major eligibility criteria or had no data at all after randomization. Here 'n' signifies number of participants evaluable at each time point for each arm respectively.||participants|||Number
761625|NCT00635349|Secondary|Number of Participants With Overall Assessment on Study Drug by Investigator|Investigator was completed overall assessment on study drug by using a 5-point scale (-2 to 2; where, -2= very bad, 1= bad, 0=moderate, 1=good and 2=very good). Study drug refers specifically to the randomized treatment received from Day 29 to Day 85.|Day 85|FAS population included all randomly assigned participants excluding those who violated the major eligibility criteria or had no data at all after randomization. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure||participants|||Number
761626|NCT00635349|Secondary|Number of Participants With Overall Assessment on Study Drug by Participants|Participants' overall assessment on study drug was done by using a 5-point scale ranging from -2 to 2 where, -2= very bad, 1= bad, 0=moderate, 1=good and 2=very good. Study drug refers specifically to the randomized treatment received from Day 29 to Day 85.|Day 85|FAS population included all randomly assigned participants excluding those who violated the major eligibility criteria or had no data at all after randomization. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure||participants|||Number
761627|NCT00635349|Secondary|Number of Participants With Pain Relief|Pain relief was assessed by using a 6-point scale ranging from -1 to 4 where, -1=pain aggravated, 0=no change, 1=slightly relieved, 2=moderately relieved, 3=considerably relieved, and 4=pain completely disappeared. Participants with pain slightly relieved, moderately relieved and completely disappeared were considered as pain relieved.|Day 29, Day 57 and Day 85|FAS population included all randomly assigned participants excluding those who violated the major eligibility criteria or had no data at all after randomization. Here 'n' signifies number of participants evaluable at each time point for each arm respectively.||participants|||Number
761628|NCT00635349|Secondary|Change From Day 29 in Pain Intensity Score at Day 85|Pain intensity was evaluated by 11- point numeric rating scale ranging from 0 to 10 where, 0=no pain and 10=pain as bad as you can imagine.|Day 29 and Day 85|Full analysis set (FAS) population included all randomly assigned participants excluding those who violated the major eligibility criteria or had no data at all after randomization. Last observation carried forward (LOCF) method was applied. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
761629|NCT00635349|Primary|Change From Day 29 in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Total Score at Day 85|The WOMAC is a self-administered and health status questionnaire designed to capture elements of pain, stiffness and physical impairment in participants with osteoarthritis. It consists of 24 questions (5 questions about pain, 2 about stiffness and 17 about physical function) scored on a visual analog scale (VAS) of 0 to 10 cm (0 cm=no pain to 10 cm=worse pain). Individual question responses are assigned a score between 0=extreme and 4=none. Maximum scores for each element differ and therefore, scores were normalized. Total normalized score ranges from 0=worst to 100=best.|Day 29 and Day 85|Full analysis set (FAS) population included all randomly assigned participants excluding those who violated the major eligibility criteria or had no data at all after randomization. Last observation carried forward (LOCF) method was applied.||units on a scale||Standard Deviation|Mean
761630|NCT00635362|Secondary|Satisfaction With LNG-IUS|"We measured satisfaction with the IUS at each visit using a single question with a 5 point Likert scale, with 1 being “very unsatisfied,” 2 “unsatisfied”, 3 “neutral,” 4 “satisfied,” and 5 “very satisfied.” For statistical purposes, subjects were determined to be SATISFIED with the IUS if they chose either 4 or 5 for this question."|12 months after cesarean delivery|Analysis only done on subjects completing 12-month visit||participants|||Number
761631|NCT00635362|Secondary|Satisfaction With LNG-IUS|"We measured satisfaction with the IUS at each visit using a single question with a 5 point Likert scale, with 1 being “very unsatisfied,” 2 “unsatisfied”, 3 “neutral,” 4 “satisfied,” and 5 “very satisfied.” For statistical purposes, subjects were determined to be SATISFIED with the IUS if they chose either 4 or 5 for this question."|6 months after cesarean delivery|Analysis only done on subject completing six-month visit||participants|||Number
761632|NCT00635362|Secondary|Perforation Rates||12 months after cesarean delivery|||participants|||Number
761633|NCT00635362|Secondary|Rates of Expulsion of the LNG-IUS||12 months after cesarean delivery|||participants|||Number
761634|NCT00635362|Primary|Use of the LNG-IUS for Contraception||12 months after cesarean delivery|||participants|||Number
761635|NCT00635427|Secondary|Percentage Change From Baseline to 24 Months in Normalized Spleen Volume for Each Treatment Group||Baseline to 24 months|||Precent (%) change||95% Confidence Interval|Mean
761636|NCT00635427|Secondary|Change From Baseline to 24 Months in Normalized Liver Volume for Each Treatment Group||Baseline to 24 months|||% Body weight||95% Confidence Interval|Mean
761637|NCT00635427|Secondary|Change From Baseline to 24 Months in Platelet Counts for Each Treatment Group||Baseline to 24 months|||(10^9/L)||95% Confidence Interval|Mean
761638|NCT00635427|Secondary|Change From Baseline to 24 Months in Hemoglobin Concentration for Each Treatment Group||Baseline to 24 months|||(g/dL)||95% Confidence Interval|Mean
761656|NCT00635492|Secondary|Changes in HbA1c From Baseline to Month 24|Changes in HbA1c From Baseline to Month 24|Baseline, Month 24|"Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.
All patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population."||percentage of total hemoglobin||Standard Deviation|Mean
761639|NCT00635427|Primary|Overall Summary of Treatment Emergent Adverse Events|Safety was evaluated by an analysis of adverse events (AEs), concomitant medication use, clinical laboratory tests, vital signs during the infusion of study drug, physical examination, and the development of anti-velaglucerase alfa. No formal comparisons or statistical tests were applied for the safety analyses, including for differences between the groups.|Baseline to termination of study|All participants who received at least 1 infusion (full or partial) of study drug were evaluated for safety (ie, were included in the safety population). There were 95 participants in the safety population.||Participants|||Number
761640|NCT00635479|Secondary|Nursing Time Cost for Dressing Changes||until wound is healed||||||
761641|NCT00635479|Secondary|Dressing Supply Costs||until wound healed||||||
761642|NCT00635479|Secondary|Hospital Length of Stay||until discharge from acute care||||||
761643|NCT00635479|Secondary|Wound Drainage||until wound healed||||||
761644|NCT00635479|Primary|Wound Infections||until wound healed|||participants|||Number
761645|NCT00635492|Secondary|Percentage of Patients Hospitalized Between Baseline and 24 Months|Percentage of Patients Hospitalized Between Baseline and 24 Months|Baseline to Month 24|"Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.
All patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population."||percentage of patients|||Number
761646|NCT00635492|Secondary|Number of Contacts With Health Care Providers Between Baseline and 24 Months|Number of contacts with Health Care Providers Between Baseline and 24 Months|Baseline to Month 24|"Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.
All patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population."||number of contacts||Standard Deviation|Mean
761647|NCT00635492|Secondary|Percentage of Patients Contacting Health Care Providers Between Baseline and 24 Months|Percentage of Patients Contacting Health Care Providers Between Baseline and 24 Months|Baseline to Month 24|"Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.
All patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population."||percentage of patients|||Number
761648|NCT00635492|Secondary|Factors Associated With Treatment Change in Exenatide BID Cohort|Hazards ratios from Backward Cox Regression Model for time to significant treatment change in Exenatide BID cohort. EQ-5D (Health Questionnaire Copyright @ Euro QoL Group 1998).|Baseline to Month 24|"Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.
All patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population."||hazard ratio||95% Confidence Interval|Number
761649|NCT00635492|Secondary|Factors Associated With Treatment Change in Insulin Cohort|Hazards ratios from Backward Cox Regression Model for time to significant treatment change in Insulin cohort|Baseline to Month 24|"Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.
All patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population."||hazard ratio||95% Confidence Interval|Number
761650|NCT00635492|Secondary|Reasons for Discontinuation of Baseline Regimen|Reasons for Discontinuation of Baseline Regimen|Baseline to Month 24|"Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.
All patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population."||number of patients|||Number
761651|NCT00635492|Secondary|Incidence of Hypoglycemia Between Baseline and 24 Months|Incidence of Hypoglycemia between Baseline and 24 Months|Baseline to Month 24|"Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.
All patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population."||percentage of patients|||Number
761652|NCT00635492|Secondary|Incidence of Gastro Intestinal Symptoms Between Baseline and 24 Months|Incidence of Gastro Intestinal Symptoms between Baseline and 24 Months|Baseline to Month 24|"Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.
All patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population."||percentage of patients|||Number
761653|NCT00635492|Secondary|Changes in Weight From Baseline to Month 24|Changes in Weight From Baseline to Month 24|Baseline, Month 24|"Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.
All patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population."||kg||Standard Deviation|Mean
761654|NCT00635492|Secondary|Percentage of Patients Achieving HbA1c Concentration <6.5% at Month 24|Percentage of Patients Achieving HbA1c Concentration <6.5% at Month 24. Note: Only patients with baseline HbA1c >=6.5% were included in this analysis.|Month 24|"Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.
All patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population."||percentage of patients|||Number
761655|NCT00635492|Secondary|Percentage of Patients Achieving HbA1c Concentration <7.0% at Month 24|Percentage of Patients Achieving HbA1c Concentration <7.0% at Month 24. Only patients with baseline HbA1c >= 7.0 % were included in this analysis|Month 24|"Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.
All patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population."||percentage of patients|||Number
761657|NCT00635492|Secondary|Higher Value of Low Density Lipoprotein Cholesterol Associated With Treatment Choice at Baseline|Higher (1 mmol/L higher) LDL cholesterol was one of the Factors evaluated for association with treatment choice at baseline. The mean LDL cholesterol at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for 1 mmol/L higher at baseline. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).|Baseline|All participants who provided consent to release information, fulfilled the study entry criteria, and had a start date provided were included in the analyses.||mmol/L||Standard Deviation|Mean
761658|NCT00635492|Secondary|Diet and Exercise Advice in Diabetes Management Associated With Treatment Choice at Baseline|Receipt of diet and exercise advice was one of the Factors evaluated for association with treatment choice at baseline. The number of participants who checked yes or no during the baseline visit for prior receipt of diet/exercise advice in his/her Diabetes management is provided below and the statistical analysis provides the 2 arms odds ratio. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).|Baseline|All participants who provided consent to release information, fulfilled the study entry criteria, and had a start date provided were included in the analyses.||participants|||Number
761659|NCT00635492|Secondary|Frequent Blood Glucose Self Monitoring Associated With Treatment Choice at Baseline|Frequent glucose self-testing (1 test/week more) was one of the Factors evaluated for association with treatment choice at baseline. The mean number of self monitoring blood glucose tests per week over the last 4 weeks prior to baseline was determined at baseline and is provided below. The statistical analysis provides the 2 arms odds ratio. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).|4 weeks prior to Baseline|All participants who provided consent to release information, fulfilled the study entry criteria, and had a start date provided were included in the analyses.||tests/week||Standard Deviation|Mean
761660|NCT00635492|Secondary|Higher Random Glucose Associated With Treatment Choice at Baseline|Random Glucose 1 millimole per liter (mmol/L) higher was one of the Factors evaluated for association with treatment choice at baseline. Random glucose is a glucose within the last 6 months prior to baseline. The mean is provided below and the statistical analysis provides the 2 arms odds ratio for the glucose 1 mmol/L higher. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).|6 months prior to Baseline|||mmol/L||Standard Deviation|Mean
761661|NCT00635492|Secondary|Disinhibited Eating Associated With Treatment Choice at Baseline|Diabetes Health Profile (DHP-18) - consists of 18 items across 3 domains (psychological distress, barriers to activity, and disinhibited eating), with each item standardized score rated from 0-100; 0=no dysfunction, higher numbers=greater dysfunction. The subscale of disinhibited eating was one of the Factors evaluated for association with treatment choice at baseline. The number of participants with disinhibited eating at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for disinhibited eating. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).|Baseline|All participants who provided consent to release information, fulfilled the study entry criteria, provided the specific data (DHP-18 subscale on disinhibited eating) and had a start date provided were included in the analyses.||units on a scale||Standard Deviation|Mean
761662|NCT00635492|Secondary|Older Age Associated With Treatment Choice at Baseline|Older age (1 year older) was one of the Factors evaluated for association with treatment choice at baseline. The mean age at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for age 1 year older. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).|Baseline|All participants who provided consent to release information, fulfilled the study entry criteria, and had a start date provided were included in the analyses.||years||Standard Deviation|Mean
761663|NCT00635492|Secondary|Higher Hemoglobin A1c (HbA1) Associated With Treatment Choice at Baseline|Higher HbA1c was one of the Factors evaluated for association with treatment choice at baseline.HbA1c was reported in percent of hemoglobin. The mean HbA1c at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for HbA1c=1% higher.|Baseline|All participants who provided consent to release information, fulfilled the study entry criteria, and had a start date provided were included in the analyses.||percent of hemoglobin||Standard Deviation|Mean
761664|NCT00635492|Secondary|Higher Body Mass Index (BMI) Associated With Treatment Choice at Baseline|Higher BMI was one of the Factors evaluated for association with treatment choice at baseline. BMI was calculated as body weight in kilograms (kg) divided by height in meters (m) squared (kg/m^2). The mean BMI at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for BMI=1 kg/m^2 higher. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).|Baseline|All participants who provided consent to release information, fulfilled the study entry criteria, and had a start date provided were included in the analyses.||kg/m^2||Standard Deviation|Mean
761677|NCT00641537|Primary|Number of Participants Who Developed Herpes Zoster Infections and Malignancies|Herpes zoster infection is defined as having at least one adverse event coded to medical dictionary for regulatory activities (MedDRA) preferred terms herpes zoster, herpes zoster iridocyclitis, herpes zoster ophthalmic, herpes zoster multi-dermatomal, herpes zoster infection neurological, herpes zoster oticus. Malignancy is defined as having at least one adverse event coded to MedDRA preferred terms under the pre_specified grouping Malignant and unspecified tumors.|Baseline up to Week 120|Safety population included all the randomized participants who had received at least 1 dose of study medication and had follow-up safety data.||Participants|||Number
762504|NCT00653159|Primary|Retention Rate|Percentage of participants who completed the final visit (i.e., not subject to early termination or loss to follow-up)|6 months|All study participants were included in the analysis.||percentage of randomized subjects|||Number
761665|NCT00635492|Primary|Estimates of Probability to Remain on Initial Injectable Treatment at 12 and 24 Months.|"The primary objective of this study is to estimate the time spent on initial treatment regime before significant treatment change for patients with type 2 diabetes initiating therapy with either insulin or exenatide for the first time.
Initial treatment regime is defined as the treatment regime prescribed when the patient is enrolled in the study.
Significant treatment change for patients initiated on insulin or exenatide is defined as at least one of the following:
Insulin:
Addition of a new medication for the treatment of type 2 diabetes
A change in the number of times insulin is administered per day
Discontinuation of any insulin initiated at baseline
Substitution of a human insulin for an analogue insulin or vice-versa.
Switching between brands of the same class/type of insulin is not included in the definition of significant treatment change.
Exenatide:
Addition of a new medication for the treatment of type 2 diabetes
Discontinuation of exenatide."|Month 24|All patients who provided consent to release information and who fulfil the study entry criteria were included in the analyses. Patients were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes.||probability (%)||95% Confidence Interval|Number
761666|NCT00635570|Post-Hoc|Continuation Rate|Rate of intention to continue the contraceptive method at 6 months|at 6 month (3 month after the end of the study period)|At 6 months, four from the contraceptive vaginal ring group and three from the oral contraceptive pill group did not complete the 6-month survey and thus were excluded from analysis.||Percentage of Participants|||Number
761667|NCT00635570|Secondary|Continuation Rate|Rate of intention to continue the contraceptive method at 3 months|at 3 months|26 participants, 15 out of the contraceptive vaginal ring group and 11 out of the oral contraceptive pill group were excluded. (See the participant flow chart)||Percentage of Participants|||Number
761668|NCT00635570|Secondary|Satisfaction Rate||at 3 months|26 participants, 15 out of the contraceptive vaginal ring group and 11 out of the oral contraceptive pill group were excluded. (See the participant flow chart)||Percentage of Participants|||Number
761669|NCT00635570|Primary|Adherence Rate (Rate of Perfect Method Use)|"Perfect use was defined as reporting never missing a pill or never removing the contraceptive vaginal ring for more than 2 hours during days 1-21 of all three monthly cycles"|For the first 3 months|||Percentage of Participants|||Number
761670|NCT00635609|Primary|Change From Baseline in Inflammatory Acne Lesion Count on the Face at 12 Weeks|Acne lesions fall into 2 groups: inflammatory and non-inflammatory. The number of inflammatory acne lesions on the face was measured at baseline and after 12 weeks. The difference (change) was calculated.|baseline and 12 weeks|intention to treat (ITT)||acne lesion count||Standard Deviation|Mean
761671|NCT00635609|Secondary|Change From Baseline in Non-inflammatory Acne Lesion Count on the Face at 12 Weeks|Acne lesions fall into 2 groups: inflammatory and non-inflammatory. The number of non-inflammatory acne lesions on the face was measured at baseline and after 12 weeks. The difference (change) was calculated.|baseline and 12 weeks|||Acne lesion count||Standard Deviation|Mean
761672|NCT00635609|Primary|Successful Outcome According to Investigator's Global Assessment (IGA)|The Investigator's Global Assessment (IGA) was performed at baseline and at 12 weeks. The IGA score is based on a 5-point acne severity scale from zero (clear) to 4 (severe). Successful outcome is at least a 2-point reduction in IGA score from baseline to 12 weeks.|baseline and 12 weeks|||participants|||Number
761673|NCT00635648|Secondary|Number of Participants With Favorable Overall Response for Esophageal Candidiasis or Invasive Candidiasis|"Efficacy response for esophageal candidiasis was based on clinical and endoscopic criteria; favorable responses included complete and partial improvement in symptoms and endoscopic lesions.
Efficacy response for invasive candidiasis was based on microbiological and clinical assessments; favorable responses required both favorable microbiological response (i.e., eradication or presumptive eradication based on symptoms, physical exam, and non-invasive tests) and complete or partial clinical response."|First dose of study drug through up to 60 days of therapy (maximum 28 days of study drug for esophageal candidiasis, 60 days for invasive candidiasis; mean treatment duration of 14 days)|Of the 63 enrolled participants, one participant with invasive candidiasis who withdrew consent before completing the efficacy assessment was not included in the efficacy analyses.||Participants|||Number
761674|NCT00635648|Secondary|Number of Participants Who Discontinued Due to a Drug-related Adverse Event|A drug-related adverse event is a determination by the investigator physician that the study drug caused the event based on exposure, time course, likely cause, dechallenge (event resolved/improved when drug was discontinued), rechallenge (event resolved/improved when drug was re-introduced), and consistency with the drug profile.|First dose of study drug through 14 days post therapy (maximum 28 days of study drug for esophageal candidiasis, 60 days for invasive candidiasis; mean treatment duration of 14 days)|||Participants|||Number
761675|NCT00635648|Secondary|Number of Participants With One or More Drug-related Adverse Events|A drug-related adverse event is a determination by the investigator physician that the study drug caused the event based on exposure, time course, likely cause, dechallenge (event resolved/improved when drug was discontinued), rechallenge (event resolved/improved when drug was re-introduced), and consistency with the drug profile.|First dose of study drug through 14 days post therapy (maximum 28 days of study drug for esophageal candidiasis, 60 days for invasive candidiasis; mean treatment duration of 14 days)|||Participants|||Number
761676|NCT00635648|Primary|Number of Participants With One or More Drug-related Serious Adverse Events|"A serious adverse event is one that results in death, disability/incapacity, or hospitalization or is life threatening, a congenital anomaly or birth defect, cancer, an overdose, or otherwise jeopardizes the patient and may require medical intervention.
A drug-related adverse event is a determination by the investigator physician that the study drug caused the event based on exposure, time course, likely cause, dechallenge (event resolved/improved when drug was discontinued), rechallenge (event resolved/improved when drug was re-introduced), and consistency with the drug profile."|First dose of study drug through 14 days post therapy (maximum 28 days of study drug for esophageal candidiasis, 60 days for invasive candidiasis; mean treatment duration of 14 days)|||Participants|||Number
761713|NCT00642616|Secondary|Number of Participants With Asthma Exacerbation by Treatment Arm|Number of participants who experienced worsening of asthma symptoms|Baseline to Week 52|Safety population: Participants who received at least one dose of study medication. The outcome applies only to participants with underlying Asthma||participants|||Number
794007|NCT00910091|Secondary|Percentage of Participants With Overall Response (OR) Including CR and PR||Up to 2 years|ITT population.||Percentage of Participants||Standard Deviation|Mean
761678|NCT00641537|Primary|Median Time to Recovery From Grade 3 or 4 Lymphocyte Toxicity|Lymphocyte toxicity was assessed using Common Terminology Criteria for Adverse Events (CTCAE). CTCAE grade for absolute lymphocyte counts included: Grade 1 = less than lower limit of normal; Grade 2 = less than 800 per cubic millimeter (/mm^3); Grade 3 = less than 500/mm^3; Grade 4 = less than 200/mm^3. Recovery from a Grade 3 or 4 toxicity is defined as a return to a Grade 0 or 1 during the CLARITY Extension Study.|Baseline up to Week 120|Safety population included all the randomized participants who had received at least 1 dose of study medication and had follow-up safety data. 'N' signifies number of participants who were evaluable for this outcome measure.||days||Full Range|Median
761679|NCT00641537|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered. SAE: Any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition.|Baseline up to week 120|Safety population included all the randomized participants who had received at least 1 dose of study medication and had follow-up safety data.||participants|||Number
761680|NCT00641537|Secondary|Time to Disability Progression (Confirmed After 3 Months)|Time to disability progression was defined as the time to a sustained increase in EDSS score of at least 1 point if baseline EDSS score between 0.5 and 4.5 inclusively, or at least 1.5 points if the baseline EDSS score was 0, or at least 0.5 point if the baseline EDSS score was at least 5, over a period of at least three months. Expanded disability status scale (EDSS) assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. As few participants have reached EDSS progression, fourth Percentile of time to sustained increase in EDSS score was reported using Kaplan-Meier survival curve.|Baseline up to Week 96|ITT population included all participants who were randomized in the study.||months|||Number
761681|NCT00641537|Secondary|Mean Number of Combined Unique (CU) Lesions|Mean Number of CU lesions were measured by using magnetic resonance imaging (MRI) scans.|Week 96|ITT population included all participants who were randomized in the study.||lesions||Standard Deviation|Mean
761682|NCT00641537|Secondary|Annualized Qualifying Relapse Rate|A qualifying relapse was defined as an increase of 2 points in at least one functional system of the expanded disability status scale (EDSS) or an increase of 1 point in at least two functional systems (excluding changes in bowel or bladder function or cognition) in the absence of fever, lasting for at least 24 hours and to have been preceded by at least 30 days of clinical stability or improvement. Expanded disability status scale (EDSS) assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to multiple sclerosis [MS]) was calculated. The annualized relapse rate for each treatment group was calculated as the total number of confirmed relapses divided by the total number of days on study multiplied by 365.25.|Week 96|Intention-to-treat (ITT) population included all participants who were randomized in the study.||relapses per year||95% Confidence Interval|Number
761683|NCT00641537|Primary|Percentage of Participants With at Least 1 Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or 4 Lymphocyte Toxicity|Lymphocyte toxicity was assessed using Common Terminology Criteria for Adverse Events (CTCAE). CTCAE grade for absolute lymphocyte counts included: Grade 1 = less than lower limit of normal; Grade 2 = less than 800 per cubic millimeter (/mm^3); Grade 3 = less than 500/mm^3; Grade 4 = less than 200/mm^3.|Baseline up to Week 120|Safety population included all the randomized participants who had received at least 1 dose of study medication and had follow-up safety data.||percentage of participants|||Number
761684|NCT00641563|Secondary|BIS-Index Awake and 3 Sedation Levels (RS 2/3/4)|BIS-Index is a dimensionless value ranging from 0-100, indicating fully awake at 100 and a flat-line electroencephalogram at 0. Standard anesthesia creates a BIS-Index range 40-60. The scale is ordinal, not interval. BIS Index is calculated from the EEG by a proprietary algorithm (Aspect Medical Inc.)|awake and 3 sedation levels (RS 2/3/4) 20 min each|||Units on a scale||Standard Deviation|Mean
761685|NCT00641563|Primary|Amplitudes (in Micro Volts) of Acoustic Event Related Potentials (Time-locked Amplitudes in the Electroencephalogram 100 Milliseconds After the Acoustic Stimulus, Averaged Over 40 Stimuli)Awake and at 3 Different Drug-induced Sedation Levels|Event Related Potentials (time-locked amplitudes in the electroencephalogram 100 milliseconds after the acoustic stimulus, averaged over 40 stimuli) Sedation levels were graded with the Ramsay scale (RS), where the responses of patients to standardized increasing stimuli (voice, then prodding, the pain stimulus) are graded. The higher the number, the deeper is the sedation. RS 6 means no response at all (= anesthesia)|awake + 3 sedation levels (RS2/3/4) (20 minutes each)|||micro Volt||Standard Deviation|Mean
761686|NCT00641641|Primary|Mean Change From Baseline Plasma HIV RNA (Log Copies/mL)|change was calculated as the mean of 12 assessments minus the baseline value|12 times within 48 weeks.|Intention to treat||log copies/mL plasma||Standard Deviation|Mean
761687|NCT00641667|Secondary|Number of Participants With Response Based on Physician’s Global Assessment Scale|The treating physician assessed the therapeutic efficacy (effectiveness) of the study drug by 2-point scale of effective and ineffective. Number of participants with effective and ineffective therapeutic efficacy with respect to the study drug were reported.|Day 10 or ED|The FAS population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug.||Participants|||Number
761688|NCT00641667|Secondary|Mean Number of Rescue Doses|Rescue dose was defined as the dose of a fast-acting opioid analgesic (except fentanyl preparations) given in case of breakthrough pain or lack of analgesic effect.|Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 or ED|The FAS population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug. 'n' signifies those participants who were evaluable for this measure at given time points.||Rescue Doses||Standard Deviation|Mean
761714|NCT00642616|Primary|Change in Post-bronchodilator FEV1 From Baseline to Week 52|Post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) is measured at the pulmonary function laboratory.|52 Weeks|Only two participants completed both time points (one in the Usual Care (Asthma) Arm and one in the Usual Care (COPD) Arm); data are not provided due to privacy concerns.|||||
794156|NCT00911534|Other Pre-specified|Time to Achieve First 24-Hour Period Without Heartburn|Participants completed a daily symptom diary.|Baseline to Week 4|ITT||Days||Standard Error|Mean
761689|NCT00641667|Secondary|Number of Participants With Total Duration of Pain Per Day|The participants assessed total painful time in 1 day on a 5-point scale ranging from 0 to 4 where 0 = less than (<) 4 hours, 1 = greater than or equal to (>=) 4 hours to less than 8 hours, 2 = greater than or equal to 8 hours to less than 12 hours, 3 = greater than or equal to 12 hours and 4 = 24 hours (all day).|Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 or ED|The FAS population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug. 'n' signifies those participants who were evaluable for this measure at given time points.||Participants|||Number
761690|NCT00641667|Secondary|Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain|Participants were asked to assess their resting pain intensity (severity of pain) on a 4-point categorical scale ranging from 0 to 3 where 0 = no pain, 1 = mild pain, 2 = moderate pain and 3 = severe pain.|Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 or ED|The FAS population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug. 'n' signifies those participants who were evaluable for this measure at given time points.||Participants|||Number
761691|NCT00641667|Secondary|Pain Intensity Visual Analog Scale (VAS) Score|Participants were asked to assess their resting pain intensity (severity of pain) on a 100-mm VAS with the left edge (0 mm) defined as “no pain” and the right edge (100 mm) defined as “severest pain conceivable”.|Day 1 (pre-application), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 or ED|The FAS population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug. 'n' signifies those participants who were evaluable for this measure at given time points.||mm||Standard Deviation|Mean
761692|NCT00641667|Secondary|Number of Participants With Response Based on Patient’s Global Assessment Scale|Participants were asked to assess their satisfaction with respect to the therapeutic efficacy (effectiveness) of the study drug on a 5-point scale ranging from 1 to 5, where 1 = extremely satisfied, 2 = satisfied, 3 = neither satisfied nor dissatisfied, 4 = dissatisfied and 5 = extremely dissatisfied.|Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 or ED|The FAS population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug. 'n' signifies those participants who were evaluable for this measure at given time points.||Participants|||Number
761693|NCT00641667|Primary|Percentage of Participants Achieving Pain Control|Pain control was assessed based on change in Visual Analog Scale (VAS) and number of daily rescue doses during 3 days before completion of study drug from 3 days before start of study drug. For VAS score, a difference of less than or equal to +15 millimeter (mm) and for rescue doses, a difference of less than or equal to 1 was considered significant to achieve pain control. Pain Intensity VAS ranged from 0 mm (no pain) to 100 mm (severest pain conceivable) and rescue dose was defined as dose of fast-acting opioid analgesic (except fentanyl preparations) used for lack of analgesic effect.|Day 10 or early discontinuation (ED)|Full Analysis Set (FAS) population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug.||Percentage of Participants||95% Confidence Interval|Number
761694|NCT00641706|Secondary|Proportion of Confirmed Tumor Response Defined as an Objective Status of Confirmed Response (CR), Partial Response (PR), or Regression (REGR) on Two Consecutive Evaluations|"Confidence intervals for the true proportion will be calculated using the exact binomial method.
Measurable patients must achieve at least a 50% reduction in the product of perpendicular diameters of contrast enhancement or mass with no new lesions with the patient being on stable or decreased steroid dose.
Evaluable patients must achieve unequivocal reduction in size of contrast-enhancement or decrease in mass effect as agreed upon independently by primary physician and quality control physicians; no new lesions. Patient should be on stable or decreased steroid dose."|Assessed up to 5 years|Arm A patients that started treatment. Arm B patients were not analyzed for this outcome because they received surgery and hence response was not measured.||proportion of patients||95% Confidence Interval|Number
761695|NCT00641706|Secondary|Time to Progression|Estimated using Kaplan-Meier survival curve. Patients who died were considered to have disease progression at the time of death unless there was documented evidence that no progression occurred before death. For patients with bidimensionally measurable disease (measurable disease), progression is defined as > 25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions. For patients without bidimensionally measurable disease (evaluable disease), progression is defined as unequivocal increase in size of contrast enhancement or increase in mass effect as agreed upon independently by primary physician and quality control physicians or appearance of new lesions.|From study registration to date of progression (up to 5 years)|Patients that started treatment.||months||Full Range|Median
761696|NCT00641706|Secondary|Overall Survival|Estimated using Kaplan-Meier survival curve.|From study registration to date of death due to any cause or last follow-up (up to 5 years)|Patients that started treatment.||months||Full Range|Median
761697|NCT00641706|Primary|Progression-free Survival at 6 Months|Estimated using the Binomial point estimator (number of successes divided by the total number of evaluable patients). A patient is classified as a success if alive and progression-free at 6 months. For patients with bidimensionally measurable disease (measurable disease), progression is defined as > 25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions. For patients without bidimensionally measurable disease (evaluable disease), progression is defined as unequivocal increase in size of contrast enhancement or increase in mass effect as agreed upon independently by primary physician and quality control physicians or appearance of new lesions.|At 6 months|Patients that started treatment.||percentage of patients|||Number
761698|NCT00641719|Secondary|Change From Baseline to One Year Endpoint in Beck Depression Inventory-II (BDI-II) Total Score|A 21-item, participant-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a 4-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.|baseline, 1 year|Intention to treat (ITT) population - participants were analyzed according to the groups to which they were originally assigned, whether or not they completed the protocol.||units on a scale||Standard Deviation|Mean
763504|NCT00656058|Secondary|Percentage Overall 2-Year Survival|Percentage of participants alive at 2 years.|2 years|This is a multicenter study and the number analyzed reflect data for evaluable subjects enrolled at the National Institutes of Health only.||percentage of participants|||Number
761699|NCT00641719|Secondary|Beck Depression Inventory-II (BDI-II) Total Score at One Year Endpoint|A 21-item, participant-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a 4-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.|1 year|Intention to treat (ITT) population - participants were analyzed according to the groups to which they were originally assigned, whether or not they completed the protocol.||units on a scale||Standard Deviation|Mean
761700|NCT00641719|Secondary|Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Interference Scores|Self-reported scale measures interference of pain on function in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life. Scores range from 0 (does not interfere) to 10 (completely interferes). Average interference = self-reported scale measures interference of pain on average of 7 questions assessing interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life. Average interference scores range from 0 (does not interfere) to 10 (completely interferes).|baseline, 1 year|Intention to treat (ITT) population - participants were analyzed according to the groups to which they were originally assigned, whether or not they completed the protocol.||units on a scale||Standard Deviation|Mean
761701|NCT00641719|Secondary|Brief Pain Inventory (BPI) Interference Scores at One Year Endpoint|Self-reported scale measures interference of pain on function in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life. Scores range from 0 (does not interfere) to 10 (completely interferes). Average interference = self-reported scale measures interference of pain on average of 7 questions assessing interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life. Average interference scores range from 0 (does not interfere) to 10 (completely interferes).|1 year|Intention to treat (ITT) population - participants were analyzed according to the groups to which they were originally assigned, whether or not they completed the protocol.||units on a scale||Standard Deviation|Mean
761702|NCT00641719|Secondary|Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Severity Scores|A self-reported scale that measures the severity of pain. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). There are 4 questions assessing worst pain, least pain, and average pain in the past 24 hours, and the pain right now.|baseline, 1 year|Intention to treat (ITT) population - participants were analyzed according to the groups to which they were originally assigned, whether or not they completed the protocol.||units on a scale||Standard Deviation|Mean
761703|NCT00641719|Secondary|Brief Pain Inventory (BPI) Severity Scores at One Year Endpoint|A self-reported scale that measures the severity of pain. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). There are 4 questions assessing worst pain, least pain, and average pain in the past 24 hours, and the pain right now.|1 year|Intention to treat (ITT) population - participants were analyzed according to the groups to which they were originally assigned, whether or not they completed the protocol.||units on a scale||Standard Deviation|Mean
761704|NCT00641719|Secondary|Change From Baseline to One Year Endpoint for Patient Global Impression of Improvement (PGI-I) Scale|A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).|baseline, 1 year|Intention to treat (ITT) population - participants were analyzed according to the groups to which they were originally assigned, whether or not they completed the protocol.||units on a scale||Standard Deviation|Mean
761705|NCT00641719|Secondary|Patient Global Impression of Improvement (PGI-I) Scale at One Year Endpoint.|A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).|1 year|Intention to treat (ITT) population - participants were analyzed according to the groups to which they were originally assigned, whether or not they completed the protocol.||units on a scale||Standard Deviation|Mean
761706|NCT00641719|Primary|Number of Participants Who Experienced an Adverse Event (AE)|See the Reported Adverse Events section for details.|baseline through 1 year|All participants who received at least 1 dose of study drug.||participants|||Number
761707|NCT00641745|Primary|Number of Participants With Adverse Events.||12 months|||participants|||Number
761708|NCT00642473|Primary|Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4|Severity of the rash was evaluated semi-quantitatively using the scale of CTCAE v3.0. Grade 0: no rash; Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening or disabling; Grade 5: Death related to rash. Same participant may be counted in more than one reported categories.|After 4 weeks of metronidazole treatment|All enrolled participants. Here, number of participants analyzed = participants who were evaluable for this outcome in respective arms.||percentage of participants|||Number
761709|NCT00642473|Primary|Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2|Severity of the rash was evaluated semi-quantitatively using the scale of Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0). Grade 0: no rash; Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening or disabling; Grade 5: Death related to rash. Same participant may be counted in more than one reported categories.|After 2 weeks of metronidazole treatment|All enrolled participants. Here, number of participants analyzed = participants who were evaluable for this outcome in respective arms.||percentage of participants|||Number
761710|NCT00642603|Primary|Progression-free Survival (PFS) in U.S. Patients Only|PFS was defined as the time from the date of randomization to the first documented occurrence of disease progression or death due to any cause.|From first patient enrolled up to approximately 48 months|This study was terminated early because interim data from a predecessor study invalidated the scientific rationale that provided justification for the conduct of this study. Efficacy analyses were not performed.||months|||Number
761711|NCT00642616|Secondary|Change in HbA1C From Baseline to Week 52||Baseline, week 52|Only two participants completed both time points (one in the Usual Care (Asthma) Arm and one in the Usual Care (COPD) Arm); data are not provided due to privacy concerns|||||
761712|NCT00642616|Secondary|Number of Participants With COPD Exacerbation by Treatment Arm|Number of participants who experienced worsening of COPD symptoms|Baseline to Week 52|Safety population: Participants who received at least one dose of study medication. The outcome applies only to participants with underlying COPD||participants|||Number
761715|NCT00642642|Secondary|Subject Live Acne Scarring Assessment Responders|Cheeks that improved by at least two points on the Subject Live Acne Scarring Assessment (SLASA) as scored by the subject were considered responders. On the SLASA scale, a score of -2 (Very Dissatisfied) was worst and a score of 2 (Very Satisfied) was best.|Baseline (prior to first treatment) compared to one, two, and three months after last treatment|Analysis was performed on the ITT population||Cheeks|||Number
761716|NCT00642642|Secondary|Evaluator Live Acne Scarring Assessment Responders|Subjects who improved by 1 point or more on the Evaluator Live Acne Scarring Assessment (ELASA), as assessed by the evaluating Investigator, are counted as responders. On the ELASA scale, a score of 0 (Clear) is best and a score of 4 (Severe) is worst.|Baseline (prior to first treatment) compared to one, two, and three months after last treatment|Number of cheeks for analysis was the ITT population||Participants|||Number
761717|NCT00642642|Primary|Subject Live Acne Scarring Assessment Responders|Cheeks that improved by at least two points on the Subject Live Acne Scarring Assessment (SLASA) as scored by the subject were considered responders. On the SLASA scale, a score of -2 (Very Dissatisfied) was worst and a score of 2 (Very Satisfied) was best.|Baseline (prior to first treatment) and four months after last treatment|Analysis was performed on the ITT population||Cheeks|||Number
761718|NCT00642642|Primary|Evaluator Live Acne Scarring Assessment Responders|Subjects who improved by 1 point or more on the Evaluator Live Acne Scarring Assessment (ELASA), as assessed by the evaluating Investigator, are counted as responders. On the ELASA scale, a score of 0 (Clear) is best and a score of 4 (Severe) is worst.|Baseline (prior to first treatment) and four months after last treatment|Analysis population was the ITT population, defined as subjects for whom product could be produced and who were randomized to study treatment, whether or not all study treatments are actually received.||Participants|||Number
761719|NCT00642668|Secondary|Percentage of Participants With Adverse Events|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|Weeks 1-40|The safety population included all participants who received at least one dose of active drug.||percentage of participants|||Number
761720|NCT00642668|Secondary|Mean Time Spent in Hemoglobin Range of 10-12 g/dL During Efficacy Evaluation Period (EEP)||Weeks 29-36|ITT population included all participants who entered the titration period and received active drug.||days||Standard Deviation|Mean
761721|NCT00642668|Secondary|Percentage of Participants Maintaining Hemoglobin Concentrations Within Range of 10-12 Grams/Deciliter (g/dL) Throughout Efficacy Evaluation Period (EEP)||Weeks 29-36|ITT population included all participants who entered the titration period and received active drug.||percentage of participants||95% Confidence Interval|Number
761722|NCT00642668|Secondary|Change From Baseline in Hemoglobin Concentration to Efficacy Evaluation Period (EEP)|The mean change Baseline Hemoglobin to the time adjusted average of Hemoglobin during the EEP.|Weeks 0-36|ITT population included all participants who entered the titration period and received active drug.||grams/deciliter (g/dL)||Standard Deviation|Mean
761723|NCT00642668|Primary|Percentage of Participants Maintaining Average Hemoglobin Concentration During Efficacy Evaluation Period (EEP) Within Target Range|The EEP was week 29 through week 36. The target range for average hemoglobin concentration was 10.0 - 12.0 g/dL.|Weeks 29-36|Intent-to-Treat (ITT) population included all participants who entered the titration period and received active drug.||percentage of participants||95% Confidence Interval|Number
761724|NCT00642694|Secondary|Hamilton Rating Scale for Depression 17-item||12 Weeks||||||
761725|NCT00642694|Secondary|Psychosocial Measures i.e. SF Health Survey, QLESQ, Social Adjustment Scale Self Report, Work and Social Adjustment Scale, Work Productivity and Activity Impairment Questionaire, and the Patients Perception of Benefits of Care.||12 Weeks||||||
761726|NCT00642694|Secondary|Sleep Latency|Number of minutes until fell asleep|12 weeks|Number of Participants with analyzable data for this outcome measure||minutes||Standard Deviation|Mean
761727|NCT00642694|Primary|Percentage of Remitters on IDS-C30 at Week 12|Remission as defined by a score of <12 on the Inventory of Depressive Symptomatology, Clinician-Rated version (IDS-C30) at Week 12; minimum possible score = 0, maximum possible score = 84; higher scores indicate worse symptom severity|12 Weeks|Participants who were randomized to treatment and completed Week 12 were included in analyses||percentage of participants|||Number
761728|NCT00642707|Primary|Maximum Change in Viral Load Following Initiation of Treatment (Viral Load is Defined as HIV-1 Copies/mL and Expressed as log10 Copies/mL).|The primary end point was the maximum change from baseline in viral load following initiation of treatment, defined as HIV-1 copies/mL, measured by the Roche Amplicor HIV-1 Monitor UltraSensitive™ Test (lower limit of detection [LLD] = 48 copies/mL).|59 days|All randomized subjects who received one dose of study drug were considered intent-to-treat (ITT) subjects and were analyzed for efficacy.||Log10copies/HIV-1 RNA/mL||Standard Deviation|Mean
761729|NCT00642746|Secondary|Time to Second Progression (From Start of First-Line Regimen)|"Number of days from the initiation of first line treatment to first documented progression. Progression will be assessed per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD), >= 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease.
Progression free survival (time to progression or death, whichever occurs first) is the same as time to progression as all of the patients in this trial progressed."|Documented by Follow-up CT scans following first line treatment, average of 225 days.|95% CI cannot be computed for FOLFOX with Erlotinib arm because there is only one patient.||Days||95% Confidence Interval|Median
761752|NCT00642902|Secondary|Number of New T1 Gd-enhancing Lesions Per Participant|Analysis of new T1 Gd-enhancing lesions was done using MRI scans.|Weeks 12, 24, 36|ITT population included all randomized participants. 'n' signifies participants who were evaluable for this measure at given time points for each group, respectively.||lesions/participant||Standard Deviation|Mean
761730|NCT00642746|Secondary|Second-line Progression Free Survival|Time to disease progression from start of second-line experimental regimen. Disease progression will be measured per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD), >= 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease.|Upon completion of follow-up, for an average of 99 days following the initiation of study treatment.|"Patients who were considered for analysis were those who received treatment in a manner consistent with the protocol, as determined by the investigator.
95% CI cannot be computed for FOLFOX with Erlotinib arm because there is only one patient."||Days||95% Confidence Interval|Median
761731|NCT00642746|Primary|Response Rates of Radiographically Measurable Disease|The primary outcome measure will be the response rates of radiographically measurable disease. Response rate of disease will be assessed per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD), >= 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease.|Disease response assessed after every 2 Treatment Cycles, or around 8 weeks.|Patients who were considered for analysis were those who received treatment in a manner consistent with the protocol, as determined by the investigator.||Number of Patients|||Number
761732|NCT00642759|Secondary|Overall Survival|The median overall survival in months|3 years|||Months||95% Confidence Interval|Median
761733|NCT00642759|Secondary|6 Month Survival Rate|The percentage of participants surviving at least six months after baseline|6 months|||percentage of participants surviving||95% Confidence Interval|Number
761734|NCT00642759|Secondary|Objective Response Rate to Carboplatin, Abraxane and Avastin|Objective response rate to carboplatin, Abraxane and Avastin according to Response Evaluation Criteria in Solid Tumors [Version 1.0]|3 years|||Participants|||Count of Participants
761735|NCT00642759|Primary|6-month Progression Free Survival Rate|Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|6 Months|||percentage of participants||95% Confidence Interval|Number
761736|NCT00642772|Primary|Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)|Self-report measure of pain (5 items), stiffness (2 items) and function (17 items) in lower extremity osteoarthritis. All items were measured on a 5-point likert scales, with higher scores indicating worse pain, stiffness, or functional limitations. Total WOMAC score ranges from 0-96.|Baseline and Following 12-Week Intervention|||units on a scale||Standard Deviation|Mean
761737|NCT00642811|Secondary|Clopidogrel Responders Final Extent IPA Post Switching Treatment - Comparing Clopidogrel to Clopidogrel Versus Clopidogrel to Ticagrelor on Day 28|IPA(%)=(PAb-PAt)/PAb*100. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. Please refer to the protocol section for details about the interventions administered.|4 hrs post first dose on day 28|Intent-to-treat analysis set: included patients who were assigned to a cohort, randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.||Percent||95% Confidence Interval|Least Squares Mean
761738|NCT00642811|Secondary|Clopidogrel Responders Final Extent IPA Post Switching Treatment - Comparing Clopidogrel to Clopidogrel Versus Clopidogrel to Ticagrelor on Day 15|IPA(%)=(PAb-PAt)/PAb*100. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. Please refer to the protocol section for details about the interventions administered.|Day 15, 4 hrs post switching|Intent-to-treat analysis set: included patients who were assigned to a cohort, randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.||Percent||95% Confidence Interval|Least Squares Mean
761739|NCT00642811|Secondary|Clopidogrel Responders Final Extent IPA Post Switching Treatment - Comparing Ticagrelor to Ticagrelor Versus Ticagrelor to Clopidogrel on Day 28|IPA(%)=(PAb-PAt)/PAb*100. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. Please refer to the protocol section for details about the interventions administered.|4 hrs post first dose on day 28|Intent-to-treat analysis set: included patients who were assigned to a cohort, randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.||Percent||95% Confidence Interval|Least Squares Mean
761740|NCT00642811|Secondary|Clopidogrel Responders Final Extent IPA Post Switching Treatment - Comparing Ticagrelor to Ticagrelor Versus Ticagrelor to Clopidogrel on Day 15|IPA(%)=(PAb-PAt)/PAb*100. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. Please refer to the protocol section for details about the interventions administered.|Day 15, 4 hrs post switching|Intent-to-treat analysis set: included patients who were assigned to a cohort, randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.||Percent||95% Confidence Interval|Least Squares Mean
761753|NCT00642902|Primary|Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Participant Per Scan|Analysis of T1 Gd-enhancing lesions was done using magnetic resonance imaging (MRI) scans. Only post-baseline scans were included in the calculation of this endpoint (excluding the Study Day 1 scan which had been conducted before first dosing).|Weeks 12 to 36|ITT population included all randomized participants.||lesions/participant/scan||95% Confidence Interval|Mean
762190|NCT00650546|Primary|Change in NAS|The NAFLD Activity Score (NAS) is an underweight sum of steatosis (score 0-3), inflammation (score 0-3), ballooning scores (0-2). The NAS can range from 0-8 with the higher score indicating more aggressive disease.|Between baseline and 28 weeks of treatment with exenatide, sub q, 5-10 mcq.|||units on a scale||Standard Deviation|Mean
761741|NCT00642811|Primary|Proportion of Clopidogrel Non-responders Who Responded to Clopidogrel or Ticagrelor. - Comparing Ticag. (Day 28 of Clop. to Ticag., and Day 14 of Ticag. to Clop.) Versus Clop. (Day 14 of Clop. to Ticag., and Day 28 of Ticag. to Clop.|The secondary definition of response to treatment is IPA >50% post treatment. The response is reported as percentage of participants of each treatment. Please refer to the protocol section for details about the interventions administered. IPA(%)=(PAb-PAt)/PAb*100. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|Day 14, and day 28, 4 hours post dose|Intent-to-treat analysis set: included patients who were assigned to a cohort, randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data. 32 subjects had IPA data; but 1 subject missing a treatment arm, did not qualify for McNemar's test.||Percent of participants|||Number
761742|NCT00642811|Primary|Proportion of Clopidogrel Non-responders Who Responded to Clopidogrel or Ticagrelor. - Comparing Ticag. (Day 28 of Clop. to Ticag., and Day 14 of Ticag. to Clop.) Versus Clop. (Day 14 of Clop. to Ticag., and Day 28 of Ticag. to Clop.)|The primary definition of response to treatment is IPA >10% post treatment. The response is reported as percentage of participants of each treatment. Please refer to the protocol section for details about the interventions administered. IPA(%)=(PAb-PAt)/PAb*100. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|Day 14 and Day 28, 4 Hrs Post Dose.|Intent-to-treat analysis set: included patients who were assigned to a cohort, randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data. 32 subjects had IPA data; but 1 subject missing a treatment arm, did not qualify for McNemar's test.||Percent of Participants|||Number
761743|NCT00642850|Secondary|Number of Participants With Anti-epoetin Antibody||Week -4 and at early withdrawal or Week 28|ITT Population.||participants|||Number
761744|NCT00642850|Secondary|Number of Participants With Red Blood Cell Transfusion During the Study|Number of participant who underwent red blood cell transfusion during the study was reported.|Week -4 up to Week 28|ITT Population.||participants|||Number
761745|NCT00642850|Secondary|Percentage of Participants Requiring Any Dose Adjustment|Percentage of participants requiring adjustment in the dose of study drug during the dose titration period (DTP: Week 1 to Week 16) and EEP (Week 17 to Week 24) was reported.|Week 1 to Week 16 and Week 17 to Week 24|ITT Population. Here, 'N' (number of participants analyzed) signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable for specified category.||percentage of participants|||Number
761746|NCT00642850|Secondary|Mean Time Spent by Participants With Hemoglobin Concentration in the Target Range During the EEP|Mean time spent by participants with hemoglobin concentration in the target range of 10.0 to 12.0 g/dL during the EEP (Week 17 to Week 24) was assessed.|Week 17 up to Week 24|ITT Population.||days||Standard Deviation|Mean
761747|NCT00642850|Secondary|Percentage of Participants Maintaining Hemoglobin Concentration Within the Target Range During EEP|Percentage of participants maintaining hemoglobin concentration within the target range of 10.0 to 12.0 g/dL during EEP (Week 17 to Week 24) was assessed.|Week 17 up to Week 24|ITT Population.||percentage of participants||95% Confidence Interval|Number
761748|NCT00642850|Secondary|Change in Hemoglobin Concentration Between Reference (SVP) and EEP|The mean change of the time adjusted average of hemoglobin from reference value obtained during the SVP (Week -4 up to Week -1) and the value during EEP (Week 17 up to Week 24) was assessed.|Week -4 up to Week -1 and Week 17 up to Week 24|The Intention-to-treat (ITT) population included all participants who had received at least 1 dose of C.E.R.A. (Week 0) and for whom data for at least 1 follow-up variable had been available.||g/dL||Standard Deviation|Mean
761749|NCT00642850|Primary|Percentage of Participants Maintaining Average Hemoglobin Concentration Within +/-1 Gram Per Deciliter (g/dL) of Reference and Within the Target Range|Percentage of participants maintaining their mean hemoglobin concentration in g/dL within plus or minus (+/-) 1 g/dL of their reference hemoglobin value, and between the target range of 10.0 and 12.0 g/dL during the efficacy evaluation period (EEP). The reference hemoglobin value was defined on the basis of the 5 assessments recorded during the Stability Verification Period (SVP) at Weeks -4, -3, -2, -1 and 0. The mean hemoglobin concentration for each individual participant during the EEP (Week 17 up to Week 24) was estimated as a time adjusted average.|Week 17 up to Week 24|Per protocol (PP) population included all participants in the safety population with the exception of participants with less than 3 recorded hemoglobin values, missing administrations of C.E.R.A., withdrawal, inadequate iron status in Weeks 16-24.||percentage of participants||95% Confidence Interval|Number
761750|NCT00642902|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs|An AE was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. An SAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. Treatment-emergent are events between first dose of study drug up to 12 weeks after the last dose of the study drug that were absent before treatment or that worsened relative to pretreatment state. Number of subjects with TEAEs included subjects with both non serious and serious TEAEs.|From the first dose of study drug administration up to 12 weeks after the last dose of the study drug|Safety population included all participants who received at least 1 dose of treatment (either active or placebo).||participants|||Number
761751|NCT00642902|Secondary|Percentage of Participants Free From Relapses|A relapse was defined as the fulfillment of all the following criteria: a) neurological abnormality, either newly appearing or re-appearing, with abnormality specified by both i) neurological abnormality separated by at least 30 days from onset of a preceding clinical event, and ii) neurological abnormality lasting for at least 24 hours; b) absence of fever or known infection (fever with temperature [axillary, orally, or intrauriculary] greater than (>) 37.5 degrees Celsius or 99.5 degrees Fahrenheit); and c) objective neurological impairment, correlating with the participant’s reported symptoms, defined as either i) increase in at least 1 of the functional systems of the Expanded Disability Status Scale (EDSS), or ii) increase of the total EDSS score. Percentage of participants free from relapses during 36-week treatment period was reported.|Baseline up to Week 36|ITT population included all randomized participants.||percentage of participants|||Number
761754|NCT00642993|Secondary|Mean Change From Baseline in Body Mass Index (BMI) at Week 12|"For participants who discontinued during the study, LOCF approach was applied to the analysis. any dropout before Week 12 was included in the analysis if the participant had a valid baseline and at least one post-baseline value.
Per protocol, participants were either obese (BMI ≥30 kg/m^2 and ≤40 kg/m^2) or overweight (BMI ≥27 kg/m^2 and <30 kg/m^2) at enrollment."|Baeline and Week 12|Intent-to-treat population consisted of all participants who received randomized treatment assignment and had the baseline body weight measurement and at least one post-baseline body weight measurement.||kg/m^2||Standard Error|Mean
761755|NCT00642993|Secondary|Mean Change From Baseline in Waist Circumference at Week 12|Participant's waist circumference was measured in centimeters. For participants who discontinued during the study, LOCF approach was applied to the analysis. any dropout before Week 12 was included in the analysis if the participant had a valid baseline and at least one post-baseline value.|Baseline and Week 12|Intent-to-treat population consisted of all participants who received randomized treatment assignment and had the baseline body weight measurement and at least one post-baseline body weight measurement.||Centimeters||Standard Error|Mean
761756|NCT00642993|Secondary|Percentage of Participants Demonstrating a Weight Loss ≥10% at Week 12|For participants who discontinued during the study, LOCF approach was applied to the analysis. any dropout before Week 12 was included in the analysis if the participant had a valid baseline and at least one post-baseline value.|Baseline and Week 12|Intent-to-treat population consisted of all participants who received randomized treatment assignment and had the baseline body weight measurement and at least one post-baseline body weight measurement.||Percentage of participants|||Number
761757|NCT00642993|Secondary|Percentage of Participants Demonstrating a Weight Loss ≥5% at Week 12|For participants who discontinued during the study, LOCF approach was applied to the analysis. any dropout before Week 12 was included in the analysis if the participant had a valid baseline and at least one post-baseline value.|Baseline and Week 12|Intent-to-treat population consisted of all participants who received randomized treatment assignment and had the baseline body weight measurement and at least one post-baseline body weight measurement.||Percentage of participants|||Number
761758|NCT00642993|Primary|Mean Change From Baseline in Body Weight at Week 12|Participant's body weight was measured in kilograms. For participants who discontinued during the study, last observation carried forward (LOCF) approach was applied to the analysis. any dropout before Week 12 was included in the analysis if the participant had a valid baseline and at least one post-baseline value.|Baseline and Week 12|Intent-to-treat population consisted of all participants who received randomized treatment assignment and had the baseline body weight measurement and at least one post-baseline body weight measurement.||Kilogram||Standard Error|Mean
761759|NCT00643006|Primary|Change of Pain Level From Baseline.|Pain was measured by The Fibromyalgia Impact Questionnaire (FIQ) subscale for Pain, which is a self-rated pain on visual analogue scale, 0-100 mm. The higher value, the worse pain.|15 weeks|Patients attending at post-test||mm||Standard Deviation|Mean
761760|NCT00643006|Primary|Six-minute Walk Test|Patient is instructed to walk as fast as she can. The distance covered during 6 minutes is documented.|15 weeks|||meter||Standard Deviation|Mean
761761|NCT00643097|Secondary|Toxicity to PEP-3 Vaccine Immunization|To assess for any potential toxicity to the PEP-3 vaccine immunization in patients with newly diagnosed glioblastoma, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was used to tabulate any toxicities attributable to PEP-3. The number of patients with toxicity attributable to vaccine while on study are tabulated.|26 months|||participants|||Number
761762|NCT00643097|Secondary|Response to Vaccination|The objective is to assess the duration of immunosuppressive cytokine secretion and to identify a receptive interval for active immunotherapy. Immunosuppression will determined by monitoring a panel of immunosuppressive serum/plasma cytokines longitudinally and by determining the response of each patient to Recombivax Hepatitis B (HB) vaccination. Response is defined as seropositive or seronegative to the Hepatitis B surface antigen.|26 months|This objective was not completed, as the test was not performed successfully.||Months||Standard Deviation|Mean
761763|NCT00643097|Primary|Clinical Efficacy of Vaccination, in Terms of Progression-free Survival (PFS)|"Time in months from the start of study treatment to the date of first progression according to Macdonald criteria, or to death due to any cause. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve.
Macdonald criteria are standard criteria in neuro-oncology. Tumor assessment was made according to the adapted MacDonald criteria based on the combined evaluation of: 1) assessment of the MRI scan for measurable, evaluable, and new lesions (made by the independent external expert too), 2) overall assessment of neurological performance (made by the investigator), 3) concomitant steroid use (as reported by the investigator)."|58 months|||months||95% Confidence Interval|Median
761764|NCT00643097|Primary|Humoral and Cellular Immune Response|Number of patients that developed a delayed-type hypersensitivity (DTH) response at following vaccination. Any skin reaction in response to the intradermal injection of the antigen was measured and recorded. A positive skin test was defined as > 5 mm induration (swelling).|26 months|The test was performed on a subset of patients in each group that were available at vaccine 8, and results posted for those 30 patients who had the tests performed.||participants|||Number
761765|NCT00643201|Secondary|Number of Treated Participants With Marked Abnormalities in Urinalysis Laboratory Tests|All tests in urine: Glucose: If missing pre-dose use ≥ 2, or if value ≥ 4, or if pre-dose = 0 or 0.5 use ≥ 2, or if pre-dose = 1 use ≥ 3, or if pre-dose = 2 or 3 use ≥ 4; Protein: If missing pre-dose use ≥ 2, or if value ≥ 4, or if pre-dose = 0 or 0.5 use ≥ 2, or if pre-dose = 1 use ≥ 3, or if pre-dose = 2 or 3 use ≥ 4; Blood: If missing pre-dose use ≥ 2, or if value ≥ 4, or if pre-dose = 0 or 0.5 use ≥ 2, or if pre-dose = 1 use ≥ 3, or if pre-dose = 2 or 3 use ≥ 4; Leukocyte esterase: If missing pre-dose use ≥ 2, or if value ≥ 4, or if pre-dose = 0 or 0.5 use ≥ 2, or if pre-dose = 1 use ≥ 3, or if pre-dose = 2 or 3 use ≥ 4;Red blood cells (RBC): If missing pre-dose use ≥ 2, or if value ≥ 4, or if pre-dose = 0 or 0.5 use ≥ 2, or if pre-dose = 1 use ≥ 3, or if pre-dose = 2 or 3 use ≥ 4; White blood cells (WBC): If missing pre-dose use ≥ 2, or if value ≥ 4, or if pre-dose = 0 or 0.5 use ≥ 2, or if pre-dose = 1 use ≥ 3, or if pre-dose = 2 or 3 use ≥ 4.|Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)|N=Treated participants who received at least one dose of study drug and had non-missing laboratory measurements.||participants|||Number
763505|NCT00656058|Secondary|Forced Expiratory Volume 1 (FEV-1)/Vital Capacity (VC)|Pulmonary function test performed for eligibility and baseline.|Baseline|||Ratio||Full Range|Median
761766|NCT00643201|Secondary|Number of Treated Participants With Marked Abnormalities in Creatine Kinase, Uric Acid, and Total Protein Laboratory Tests|Creatine kinase High: >5*ULN Units/Liter (U/L); Total Protein High/Low: < 0.9 *LLN or > 1.1*ULN, or if pre-dose < LLN then use 0.9* pre-dose or > ULN if pre-dose > ULN then use 1.1 *pre-dose or <LLN; Uric acid High: > 1.5* ULN, or if pre-dose > ULN then use > 2 *pre-dose.|Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)|N=Treated participants who received at least one dose of study drug and had non-missing laboratory measurements.||participants|||Number
761767|NCT00643201|Secondary|Number of Treated Participants With Marked Abnormalities in Kidney and Liver Function Laboratory Tests|Blood urea nitrogen (BUN), milligrams/deciliter (mg/dL), units per liter (U/L). BUN mg/dL High: > 1.5*ULN; Creatinine mg/dL: > 1.5*ULN; Alanine aminotransferase (ALT) U/L: > 3*ULN; Aspartate aminotransferase (AST) U/L: > 3*ULN; Alkaline phosphatase U/L: > 2*ULN; Bilirubin Direct mg/dL: > 1.5*ULN; Bilirubin Total mg/dL: > 2*ULN.|Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)|N=Treated participants who received at least one dose of study drug and had non-missing laboratory measurements.||participants|||Number
761768|NCT00643201|Secondary|Number of Treated Participants With Marked Abnormalities in Electrolyte Laboratory Tests|Bicarbonate milliequivalents/Liter (mEq/L) Low/High: < 0.75*LLN or > 1.25*ULN, or if pre-dose < LLN then use < 0.75*pre-dose or > ULN if pre-dose > ULN then use > 1.25*pre-dose or < LLN; Serum Calcium mg/dL Low/High: < 0.8*LLN or > 1.2*ULN, or if pre-dose < LLN then use < 0.75*pre-dose or > ULN if pre-dose > ULN then use > 1.25*pre-dose or < LLN; Serum Chloride mEq/L: < 0.9*LLN or > 1.1*ULN, or if pre-dose < LLN then use < 0.9*pre-dose or > ULN if pre-dose > ULN then use > 1.1*pre-dose or < LLN; Serum Potassium mEq/L: < 0.9*LLN or > 1.1*ULN, or if pre-dose < LLN then use < 0.9*pre-dose or > ULN if pre-dose > ULN then use > 1.1*pre-dose or < LLN; Serum Sodium mEq/L: < 0.95*LLN or > 1.05*ULN, or if pre-dose < LLN then use < 0.95*pre-dose or > ULN if pre-dose > ULN then use > 1.05*pre-dose or < LLN.|Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)|N=Treated participants who received at least one dose of study drug and had non-missing laboratory measurements.||participants|||Number
761769|NCT00643201|Secondary|Number of Treated Participants With Marked Abnormalities in Hematology Laboratory Tests|Lower limit of normal (LLN). Upper limit of normal (ULN). Pre-therapy (PreRx). Absolute (Abs) neutrophil count, bands + neutrophils (ANC). Cells per microliter (c/µL). Grams per deciliter (g/dL). Cells per Liter (c/L). Millimeter (MM). White blood cells: < 0.75*LLN, > 1.25*ULN; Hemoglobin: <= 11.5 g/dL (males), <= 9.5 g/dL (females); Hematocrit: <= 37% (males), <= 32% (females); Erythrocytes: <0.75*10^6 c/µL*PreRx; Platelet count: < 75*10^9 c/L, > 700*10^9 c/L; ANC: < 1.00*10^3 c/µL; Abs eosinophils: > 0.750*10^3 c/µL; Abs Basophils: > 400/MM^3; Abs Monocytes> 2000/MM^3; Abs Lymphocytes: < 0.750*10*3 c/ µL, > 7.5*10^3 c/ µL.|Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)|N=Treated participants who received at least one dose of study drug and had non-missing laboratory measurements.||participants|||Number
761770|NCT00643201|Secondary|Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Bleeding AEs, Discontinuations Due to AEs and Death During the Treatment Period in Treated Participants|Treated Participants: all who received at least 1 dose of study drug. Participants categorized to the treatment group to which they were assigned unless incorrect study treatment was received throughout the study, in which case the participant was categorized according to treatment received. Included all SAEs and AEs with onset from first dose to last dose + 2 days (for AEs) or + 30 days (for SAEs); note; bleeding AEs and SAEs from first dose to last dose + 2 days included. Discontinuations due to AE included all AEs/SAEs from first dose until drug was discontinued. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|First dose to last dose of 24 Weeks + 2 days (AEs) or + 30 days (SAEs) or until drug discontinued|Total number of participants receiving at least one dose of study drug. Participants were categorized according to the actual treatment received.||participants|||Number
761771|NCT00643201|Secondary|Incidence of Adjudicated Total Bleeding During the Treatment Period in Treated Participants|Bleeding defined by International Society on Thrombosis and Haemostasis: Total Bleeding defined as any of major, CRNM, or minor bleeding. All events were adjudicated by an ICAC blinded to treatment. Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of participants in respective treatment group (all participants who received at least one dose of study drug). Participants were categorized to the treatment group to which they were assigned unless incorrect study treatment was received throughout the study, in which case the participant was categorized according to the treatment received.|Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)|Total number of participants receiving at least one dose of study drug n/N: 402/2676; 676/2689, in apixaban and enoxaparin/warfarin groups, respectively. CI for event rate calculated based on Wald asymptotic confidence limits. Participants were categorized according to the actual treatment received.||proportion of participants||95% Confidence Interval|Number
761772|NCT00643201|Secondary|Incidence of Adjudicated Minor Bleeding During the Treatment Period in Treated Participants|Bleeding defined by International Society on Thrombosis and Haemostasis: Minor bleeding: all acute clinically overt bleeding events not meeting the criteria for either major bleeding or CRNM. All events wre adjudicated by an ICAC blinded to treatment. Event rate (proportion of participants) calculated as n/N (n=number of participants with observation; N=Total number of participants in respective treatment group (all participants who received at least one dose of study drug). Participants were categorized to the treatment group to which they were assigned unless incorrect study treatment was received throughout the study, in which case the participant was categorized according to the treatment received.|Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)|Total number of participants receiving at least one dose of study drug n/N: 313/2676; 505/2689, in apixaban and enoxaparin/warfarin groups, respectively. CI for event rate calculated based on Wald asymptotic confidence limits. Participants were categorized according to the actual treatment received.||proportion of participants||95% Confidence Interval|Number
761889|NCT00644332|Secondary|Determine the Effect of Ranolazine on Nitroglycerin Consumption as Measured by Patient-reported Diaries|Nitroglycerin use was recorded by subjects in their diaries. Weekly frequency of NTG use was calculated for the two-week baseline period and the last two weeks of the study.|Baseline to Week 4|"Modified Intent-to-Treat Analysis Set
Missing values were excluded"||uses per week||Standard Error|Mean
761773|NCT00643201|Secondary|Incidence of Adjudicated Clinically Relevant Non Major (CRNM) Bleeding During the Treatment Period in Treated Participants|Bleeding defined by International Society on Thrombosis and Haemostasis: CRNM defined as acute clinically overt bleeding: compromising hemodynamics, leading to hospitalization, hematoma, epistasis >5 minutes or repetitive, gingival bleeding, hematuria, macroscopic gastrointestinal hemorrhage, rectal blood loss, hemoptysis. All events were adjudicated by an ICAC blinded to treatment. Event rate (proportion of participants with event): calculated as n/N (n=number of participants with observation; N=Total number of participants in respective treatment group (all participants who received at least one dose of study drug). Participants were categorized to the treatment group to which they were assigned unless incorrect study treatment was received throughout the study, in which case the participant was categorized according to the treatment received.|Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)|Total number of participants receiving at least one dose of study drug n/N: 103/2676; 215/2689, in apixaban and enoxaparin/warfarin groups, respectively. CI for event rate calculated based on Wald asymptotic confidence limits. Participants were categorized according to the actual treatment received.||proportion of participants||95% Confidence Interval|Number
761774|NCT00643201|Secondary|Incidence of Adjudicated Major/CRNM Bleeding During the Treatment Period in Treated Participants|Major Bleeding = acute, clinically overt bleeding: decrease in hemoglobin of 2 g/dL or more, or bleeding leading to transfusion, or bleeding in a critical site, or fatal bleeding. CRNM = acute clinically overt bleeding: compromising hemodynamics, leading to hospitalization, hematoma, epistasis >5 minutes or repetitive, gingival bleeding, hematuria, macroscopic gastrointestinal hemorrhage, rectal blood loss, hemoptysis. Minor =: All acute clinically overt bleeding events not meeting the criteria for either major bleeding or CRNM. All events were adjudicated by an ICAC blinded to treatment. Total bleeding = any of major, or CRNM, or minor bleeding. Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of treated (received at least 1 dose of study drug).|Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)|Total number of participants receiving at least one dose of study drug n/N: 115/2676; 261/2689, in apixaban and enoxaparin/warfarin groups, respectively. CI for event rate calculated based on Wald asymptotic confidence limits. Participants were categorized according to the actual treatment received.||proportion of participants||95% Confidence Interval|Number
761775|NCT00643201|Secondary|Incidence of Adjudicated Major Bleeding During the Treatment Period in Treated Participants|All events were adjudicated by an ICAC blinded to treatment. Bleeding defined by International Society on Thrombosis and Haemostasis: Major Bleeding: acute, clinically overt bleeding: decrease in hemoglobin (hgb) of 2 g/dL or more or bleeding leading to transfusion or bleeding in a critical site or fatal bleeding. Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of participants in respective treatment group (all participants who received at least one dose of study drug). Participants were categorized to the treatment group to which they were assigned unless incorrect study treatment was received throughout the study, in which case the participant was categorized according to the treatment received.|Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)|Total number of participants receiving at least one dose of study drug n/N: 15/2676; 49/2689, in apixaban and enoxaparin/warfarin groups, respectively. CI for event rate calculated based on Wald asymptotic confidence limits. Participants were categorized according to the actual treatment received.||proportion of participants||95% Confidence Interval|Number
761776|NCT00643201|Secondary|Incidence of All-Cause Death During the Intended Treatment Period|Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Includes events that occurred during the intended treatment period, regardless of whether the participant received study medication (ITT principle). Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of participants, excluding those with missing endpoint information).|Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)|Total number of participants excluding those with missing endpoint (n/N: 41/2608; 52/2630). Events included regardless of whether or not participant received treatment, ie, ITT principle. CI for event rate calculated based on Wald asymptotic confidence limits.||proportion of participants||95% Confidence Interval|Number
761777|NCT00643201|Secondary|Incidence of Cardiovascular (CV)-Related Death Including VTE-related Death During the Intended Treatment Period|VTE-related death included: DVT-related death or PE-related death. All events were adjudicated by an ICAC blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants with event) calculated as n/N (n=number of participants with observation; N=total number of participants in respective treatment groups excluding participants with missing endpoint information). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Includes events that occur during the intended treatment period regardless of whether or not the participant received study medication (ITT principle).|Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)|Total number of participants in respective groups excluding those with missing endpoint information (n/N: 15/2608; 23/2630). CI for event rate calculated based on Wald asymptotic confidence limits.||proportion of participants||95% Confidence Interval|Number
761778|NCT00643201|Secondary|Incidence of Adjudicated Venous Thromboembolism (VTE)-Related Death During the Intended Treatment Period|VTE-related death included: DVT-related death or PE-related death. All events were adjudicated by an ICAC blinded to treatment. DVT was assessed by compression ultrasound and/or venography; PE was assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants with event) calculated as n/N (n=number of participants with observation; N=total number of participants in respective treatment groups excluding participants with missing endpoint information). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Includes events that occur during the intended treatment period regardless of whether or not the participant received study medication (ITT principle).|Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)|Total number of participants in respective treatment groups excluding participants with missing endpoint information. (n/N: 12/2608; 16/2630). CI for event rate calculated based on Wald asymptotic confidence limits.||proportion of participants||95% Confidence Interval|Number
763506|NCT00656058|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|71 months and 17 days|||participants|||Number
761779|NCT00643201|Secondary|Incidence of Adjudicated Symptomatic Nonfatal Pulmonary Embolism (PE) During the Intended Treatment Period|PE adjudicated by an ICAC blinded to treatment. PE: spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Includes events that occurred during the intended treatment period, regardless of whether the participant received study medication (ITT principle). Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of participants, excluding those with missing endpoint). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early).|Day 1 to Week 24 + + 2 Days or 355 Days (Discontinued Early)|Total number of participants in each randomized arm (ITT), excluding those with missing endpoint (n/N: 27/2606; 25/2632). CI for event rate calculated based on Wald asymptotic confidence limits.||proportion of participants||95% Confidence Interval|Number
761780|NCT00643201|Secondary|Incidence of Adjudicated Symptomatic Nonfatal Deep Vein Thrombosis (DVT) During the Intended Treatment Period|DVT adjudicated by an ICAC blinded to treatment. DVT evaluated by: compression ultrasound and/or venography. Includes events that occurred during the intended treatment period, regardless of whether the participant received study medication, intent to treat principle (ITT). Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of participants, excluding those with missing endpoint). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early).|Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early)|Total number of participants in each randomized arm (ITT), excluding those with missing endpoint (n/N: 22/2608; 35/2633). CI for event rate calculated based on Wald asymptotic confidence limits.||proportion of participants||95% Confidence Interval|Number
761781|NCT00643201|Secondary|Incidence of Adjudicated Composite of Recurrent Symptomatic VTE, Myocardial Infarction, Stroke, CV-related Death, Clinically Relevant Non-major (CRNM) Bleeding or Major Bleeding|VTE=Nonfatal DVT or nonfatal PE adjudicated by ICAC blinded to treatment. DVT: compression ultrasound and/or venography; PE: spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Major Bleeding = acute, clinically overt bleeding: decrease in Hgb of 2 g/dL or more or bleeding leading to transfusion or bleeding in a critical site or fatal bleeding. CRNM = acute clinically overt bleeding: compromising hemodynamics, leading to hospitalization, hematoma, epistasis >5 minutes or repetitive, gingival bleeding, hematuria, macroscopic gastrointestinal hemorrhage, rectal blood loss, hemoptysis. n/N (n=number of participants with observation; N=Total number of participants, excluding those with missing endpoint and including those not in the efficacy evaluable population with a bleeding event that occurred during treatment period). Events included regardless of whether or not treatment was received (ITT).|Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early)|Total number participants in each treatment group, excluded those with missing endpoint and included those not in the efficacy evaluable population with bleeding event which occurred during treatment (n/N: 183/2617; 333/2641). Events included as per ITT principle. CI for event rate calculated based on Wald asymptotic confidence limits.||proportion of participants||95% Confidence Interval|Number
761782|NCT00643201|Secondary|Incidence of Adjudicated Composite of Recurrent Symptomatic VTE or VTE-related Death or Major Bleeding|VTE included: nonfatal DVT or nonfatal PE. All events were adjudicated by an ICAC blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Major bleeding defined by International Society on Thrombosis and Haemostasis: acute, clinically overt bleeding associated with decrease in hemoglobin (Hgb) of 2 g/dL or more or bleeding leading to transfusion or bleeding in a critical site or bleeding that is fatal . Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of participants, excluding those with missing endpoint and including those not in the efficacy evaluable population with a bleeding event that occurred during treatment period. Events included regardless of whether or not participant received treatment, ie, ITT principle|Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early)|Total number of participants in each randomized arm, excluded those with missing endpoint and included those not in the efficacy evaluable population with bleeding event which occurred during treatment (n/N: 73/2610; 118/2635). Confidence interval (CI) for event rate calculated based on Wald asymptotic confidence limits.||proportion of participants||95% Confidence Interval|Number
761783|NCT00643201|Secondary|Incidence of Adjudicated Composite of Recurrent Symptomatic VTE or Cardiovascular (CV)-Related Death|VTE included: nonfatal DVT or nonfatal PE. All events were adjudicated by an ICAC blinded to treatment. DVT was assessed by compression ultrasound and/or venography; PE was assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants with event) calculated as n/N (n=number of participants with observation; N=total number of efficacy evaluable participants, participants with missing endpoint information excluded). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received, ie, ITT principle. Each participant scored as having an event only if the participant experienced one or more of the elements of the composite.|Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early)|All randomized participants with non-missing secondary endpoint (n/N: 61/2609; 77/2635, in apixaban, enoxaparin/warfarin arms, respectively). Participants categorized to assigned arm, regardless of treatment actually received. Intent to Treat principle. CI for event rate calculated based on Wald asymptotic confidence limits.||proportion of participants||95% Confidence Interval|Number
761784|NCT00643201|Secondary|Incidence of Adjudicated Composite of Recurrent Symptomatic Venous Thromboembolism (VTE) or All-Cause Death|VTE included: nonfatal DVT or nonfatal PE. All events were adjudicated by an ICAC blinded to treatment. DVT was assessed by compression ultrasound and/or venography; PE was assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants with event) calculated as n/N (n=number of participants with observation; N=total number of efficacy evaluable participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received, ie intent to treat (ITT) principle. Each participant scored as having an event only if they experienced one or more of the elements of the composite. Participants with missing endpoint information excluded.|Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early)|All randomized participants with non-missing secondary endpoint (n/N: 84/2609; 104/2635, in apixaban, enoxaparin/warfarin arms, respectively). Participants categorized to assigned arm, regardless of treatment actually received. Intent to Treat principle. Confidence interval (CI) for event rate calculated based on Wald asymptotic confidence limits.||proportion of participants||95% Confidence Interval|Number
761785|NCT00643201|Primary|Incidence of Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or VTE-Related Death During 6 Months of Treatment|VTE: nonfatal deep vein thrombosis (DVT) or nonfatal pulmonary embolism (PE). All events were adjudicated by an ICAC blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants): n/N (n=number of participants with observation; N=total number of efficacy evaluable participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint: events at any time from randomization until end of intended treatment, regardless whether drug treatment was received. All randomized participants with a non-missing primary endpoint were summarized. Missing endpoint = outcomes which could not be documented on or after study Day 154. Participants were categorized to the assigned group regardless of the treatment actually received (intent-to-treat).|Day 1 to Week 24 + 2 Days or 355 days (Discontinued Early)|All randomized participants with a non-missing primary endpoint (n/N: 59/2609; 71/2635, in apixaban, enoxaparin/warfarin, respectively). Intent-to-treat population. Confidence interval (CI) for event rate calculated based on the Wald asymptotic confidence limits.||proportion of participants||95% Confidence Interval|Number
761786|NCT00643448|Secondary|Compliance With Trans Telephonic Monitoring (TTM)|Percentage of twice daily TTM recordings (individual compliance) transmitted and available for analysis|During treatment days 1-10|||Percentage of recordings analysed||Full Range|Mean
761787|NCT00643448|Secondary|Estimated Cmax (Maximum Plasma Concentration) (PK Modeling) at Steady-state|Population PK model parameter estimates derived from plasma concentrations of AZD1305|During treatment days 1-10|||μmol/L||Full Range|Mean
761788|NCT00643448|Secondary|Adverse Events (AE)|Number of patients who had at least one AE according to the definition in the study protocol|During treatment days 2-10|||Participants|||Number
761789|NCT00643448|Primary|Maximum QTcF|Maximum of all QTcF values obtained for any given patient from randomisation until the intended end of the study drug period, day 10.|During treatment days 2-10|||ms||Full Range|Mean
761790|NCT00643487|Primary|Number of Participants With Successful Recording.|Observe the behavior of the IPP of the knee by fluoroscopy. A complete recording was obtained in 2 patients: this implied that the plica,central body, and fat pad were visualized. The patients then completed a series of manouevres which demonstrated the mechanical behavior of the infrapatellar plica-fat pad complex.|During procedure, on average one hour.|||Participants|||Number
762539|NCT00653224|Secondary|Ocular Itching/Burning Score Over the Second Week|The ocular itching/burning score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided.|Over week 2|Number of participants from the ITT population with available ocular itching/burning score over Week 2||points on a scale||Standard Deviation|Mean
761802|NCT00643578|Secondary|FEV1|The forced expiratory volume in the first second, expressed as a percent predicted.|1 hour after dose|Of the 12 subjects who qualified for randomization, 2 had a PC20 greater than 128 mg/mL (the maximum concentration of methacholine administered), after receiving 12 mcg of formoterol. Therefore, they were discontinued from the study since their PC20 would not be measurable with a higher dose of formoterol.||percent predicted||Standard Deviation|Mean
761803|NCT00643578|Primary|Post-dose PC20|The PC20 is the provocational dose of methacholine causing a 20% drop in forced expiratory volume in the first second.|3-7 days after visits 1 and 2|Of the 12 subjects who qualified for randomization, 2 had a PC20 greater than 128 mg/mL (the maximum concentration of methacholine administered), after receiving 12 mcg of formoterol. Therefore, they were discontinued from the study since their PC20 would not be measurable with a higher dose of formoterol.||mg/mL||95% Confidence Interval|Geometric Mean
761804|NCT00643604|Secondary|Patient Impression of Change Questionnaire|A Patient Global Impression of Change Questionnaire, which consists of three items that ask the subject to rate changes (much better, somewhat better, about the same, somewhat worse, much worse) in their symptoms of PAH, the amount of time spent on activities associated with preparing and administering PAH therapy, and their satisfaction with their PAH therapy since transitioning from epoprostenol to intravenous Remodulin was conducted at Week 8 only and responses are reported as frequency distributions.|Week 8|Two subjects had a Week 8 visit that was outside of the visit window and are included in the summary. One subject died prior to completing the Week 8 visit.||participants|||Number
761805|NCT00643604|Secondary|Change in Signs and Symptoms of PAH- Chest Pain|The presence or absence of chest pain was documented. If present, the intensity of chest pain was rated mild, moderate, or severe.|Baseline and Week 8|||participants|||Number
761806|NCT00643604|Secondary|Change in Signs and Symptoms of PAH- Syncope|The presence or absence of syncope was documented. If present, the intensity of syncope was rated mild, moderate, or severe.|Baseline and Week 8|||participants|||Number
761807|NCT00643604|Secondary|Change in Signs and Symptoms of PAH- Dizziness|The presence or absence of dizziness was documented. If present, the intensity of dizziness was rated mild, moderate, or severe.|Baseline and Week 8|||participants|||Number
761808|NCT00643604|Secondary|Change in Signs and Symptoms of PAH- Orthopnea|The presence or absence of orthopnea was documented. If present, the intensity of orthopnea was rated mild, moderate, or severe.|Baseline and Week 8|||participants|||Number
761809|NCT00643604|Secondary|Change in Signs and Symptoms of PAH- Dyspnea|The presence or absence of dyspnea was documented. If present, the intensity of dyspnea was rated mild, moderate, or severe.|Baseline and Week 8|||participants|||Number
761810|NCT00643604|Secondary|Change From in Signs and Symptoms of PAH- Edema|The presence or absence of edema was documented. If present, the intensity of edema was rated mild, moderate, or severe.|Baseline and Week 8|||participants|||Number
761811|NCT00643604|Secondary|Change in PAH Signs and Symptoms- Fatigue|The presence or absence of fatigue was documented. If present, the intensity of fatigue was rated mild, moderate, or severe.|Baseline and Week 8|Two subjects had a Week 8 visit that was outside of the visit window and are included in the summary. One subject died prior to Week 8 assessments.||participants|||Number
761848|NCT00643916|Primary|Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination.||Day 0 (baseline) and Day 28 post-Vaccinations 1 and 2|Serum Bactericidal Assay Human Complement antibody titers to each of the 4 meningococcal serogroups in the vaccine was evaluated in the per-protocol population.||Percentage of Participants|||Number
763757|NCT00671749|Secondary|Global Severity Assessment Success|Global Severity was assessed on a 6 point scale (Clear, Almost Clear, Mild, Moderate, Severe). The scale was dichotomized to success or failure where success = Clear or Almost Clear|6 and 12 weeks|||participants|||Number
761812|NCT00643604|Secondary|Change in Total Weekly Time Spent With the Specific Activities Associated With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol|A Drug Administration Activities Diary, used by subjects to record in detail the amount of time (in minutes) spent on specifically-defined drug preparation/administration activities (e.g. diluting drug, preparing reservoir, and changing tubing), was completed over a 7-day period during the Screening period while on epoprostenol and repeated at Week 7 following transition to Remodulin. Drug Administration Activities Diary results are reported as average time per week spent on drug administration activities|Baseline and Week 8|"Two subjects did not have Week 8 Drug Administration Activity Diaries completed.
Connect Drug and Total Time Components: N=4; One subject did not have data recorded for Connect drug activities. Total time could not be calculated for this subject."||minutes||Standard Deviation|Mean
761813|NCT00643604|Secondary|Change in Score on Treatment Satisfaction Questionnaire for Medication|The Treatment Satisfaction Questionnaire for Medication (TSQM), a validated generic measure of treatment satisfaction consisting of 14 Likert-response items comprising four domains: Effectiveness, Side Effects, Convenience, and Global Satisfaction. The TSQM was completed at baseline and at Week 8. The TSQM consists of 13 items that made up three specific scales (Effectiveness, Side effects, Convenience) and one global satisfaction scale. TSQM items are scaled using either a 5-point or 7-point scale. Five-point scales are used for unidimensional continua (e.g. extremely satisfied to not at all), while 7-point scales are used for bipolar continua(e.g., extremely positive to extremely negative. Non-neutral midpoints are used for 7-point scales, resulting in a greater range of positive response options than negative options for these items. Scale scores are transformed into scores ranging from 0 to 100, with a higher score indicating more satisfaction.|Baseline and Week 8|Two subjects had a Week 8 visit that was outside of the visit window and are included in the summary. One subject died prior to completing the Week 8 visit.||units on a scale||Standard Deviation|Mean
761814|NCT00643604|Secondary|Change in Score on Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR)|The Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR), a validated PAH-specific instrument consisting of 65 items used to assess symptoms, functioning and quality of life. The questionnaire is divided into three sections; Symptoms (Scores 0-25; high scores indicate more symptoms), Activity (Score 0-30; low score indicates good functioning)and Quality of Life (0-25; high scores indicate poor QoL). The sum of these scores equates to the Total score (0-80). In the CAMPHOR scores, lower scores indicate improvements.|Baseline and Week 8|Two subjects with a Week 8 visit outside of the visit window are included in the summary. One subject died prior to completing the Week 8 visit. One subject had an incomplete Baseline questionnaire and the CAMPHOR Activity component could not be calculated, therefore N=5 Activity and Total Score Components, and N=6 for Symptom and Quality of Life.||units on a scale||Standard Deviation|Mean
761815|NCT00643604|Secondary|Change in Borg Dyspnea Score Immediately After Six Minute Walk|The Borg Dyspnea Score is a 10-point scale rating the maximum level of dyspnea experienced after the Six-Minute Walk Test. Scores range from 0 (for the best condition) to 10 (for the worst condition).|Baseline and Week 8|Two subjects had a Week 8 visit that was outside of the visit window and are included in the summary. One subject died prior to Week 8 assessments.||units on a scale||Standard Deviation|Mean
761816|NCT00643604|Secondary|Change in WHO Functional Classification|Class I: No limitation of physical activity. Class II: Slight limitation of physical activity. Class III: Marked limitation of physical activity. Class IV: Inability to carry out any physical activity without symptoms.|Baseline and Week 8|Two subjects had a Week 8 visit that was outside of the visit window and are included in the summary. One subject died prior to Week 8 assessments.||participants|||Number
761817|NCT00643604|Primary|Change in Six Minute Walk Distance||Baseline and Week 8|Two subjects had a Week 8 visit that was outside of the visit window and are included in the summary. One subject died prior to Week 8 assessments.||meter||Standard Deviation|Mean
761818|NCT00643682|Secondary|Number of Repeat Procedures Recommended Due to Inadequate Bowel Preparation.|The number of times a colonoscopist recommended that the bowel was too unclean to qualify as an acceptable colonoscopy and therefore recommended repeating the procedure after better cleansing. This is both the number of participants with an inadequate preparation and the number of inadequate procedures. These are synonymous.|2 years|||participants who had a colonoscopy|||Number
761819|NCT00643682|Secondary|Time to Withdraw Colonoscope From Tip of Cecum to Anus.|Time in minutes to withdraw colonoscope from tip of cecum to anus during withdrawal phase of colonoscopy|2 years|||Time in minutes||Inter-Quartile Range|Median
761820|NCT00643682|Secondary|Time to Advance Colonoscope From Anus to Tip of Cecum.|time in minutes to advance colonoscope from anus to tip of cecum during insertion phase of colonoscopy.|2 years|||time in minutes||Inter-Quartile Range|Median
761821|NCT00643682|Primary|Boston Bowel Preparation Scale Score|An ordinal scale. 0=fully unprepared colon and 9=perfectly clean colon. Higher values represent a better outcome. For reference please see: Lai EJ, Calderwood AH, Doros G, Fix OK, Jacobson BC. The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research. Gastrointestinal Endoscopy 2009;69:620-625. PMCID: PMC2763922|2 years|||units on a scale||Inter-Quartile Range|Median
761822|NCT00643760|Secondary|Change From Baseline in Emotional Functioning as Assessed by the Profile of Mood States-Brief Form (POMS-B) at EOMT Using LOCF Data|The POMS-B, an emotional functioning instrument, assesses mood, tension, and other psychological symptoms and consists of 30-items assessed on a 5-point scale (0=not at all to 4=extremely). 6 summary scores are calculated: Tension/Anxiety, Depression/Rejection, Anger/Hostility, Vigor/Activity, Fatigue/Inertia, and Confusion/Bewilderment; and range from 0-20 (higher scores = more negative mood state). Analysis of this endpoint is based on the change from baseline (BL) (EOMT score minus the BL score) using an ANCOVA model with BL value, BMI, grouped center as covariates.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. Not all participants completed a POMS-B at both Baseline and Week 13/Withdrawal; as such, the number analyzed is different from the full ITT Population counts.||scores on a scale||Standard Error|Least Squares Mean
761849|NCT00644059|Secondary|Incidence Rate of the 2009-2010 H1N1 Swine Pandemic Caused by a Novel Influenza A (H1N1) Virus of Swine Origin in Unprimed Children Aged 6 to <36 and 6 to <72 Months||3 weeks after 2nd vaccination|Adequate data was not available for assessing the incidence rates of the 2009-2010 swine pandemic caused by a novel influenza A (H1N1) virus of swine origin.|||||
763758|NCT00671749|Primary|Percent Change From Baseline in Total Lesion Counts||6 and 12 weeks|||Percent Change||Standard Deviation|Mean
761823|NCT00643760|Secondary|Change From Baseline in Quality of Life as Assessed by the 36-Item Short Form Health Survey (SF-36) at EOMT Using LOCF Data|The SF-36 is a general health-related quality of life instrument consisting of 36 items with various response options (Yes/No, 5- to 6-point Likert scale). Summary scores are calculated for 8 domains and 2 components (physical and mental); where scores range from 0 to 100 (higher scores = better quality of life). Analysis of this endpoint is based on the change from baseline (BL) (EOMT score minus the BL score) using an ANCOVA model with BL value, BMI, grouped center as covariates.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. Not all participants completed an SF-36 at both Baseline and Week 13/Withdrawal; as such, the number analyzed is different from the full ITT Population counts.||scores on a scale||Standard Error|Least Squares Mean
761824|NCT00643760|Secondary|Change From Baseline in Severity of Pain and the Impact of Pain as Assessed by the Brief Pain Inventory (BPI) at EOMT Using LOCF Data|The BPI, a general pain instrument, assesses the severity and interference of pain; and consists of 6 items assessed on an 11-point NRS (0=no impact and 10=greatest impact). 2 summary scores are calculated: BPI Severity Score (average of first 4 items) and BPI Interference Score (average of 7 responses to item 6); where each summary score ranges from 0 to 10 (0=no impact and 10=greatest impact). Analysis of this endpoint is based on the change from baseline (BL) (EOMT score minus the BL score) using an ANCOVA model with BL value, BMI, grouped center as covariates.|Baseline and EOMT|ITT Population. Not all participants completed a BPI assessment at both Baseline and Week 13/Withdrawal; as such, the number analyzed is different from the full ITT Population counts.||scores on a scale||Standard Error|Least Squares Mean
761825|NCT00643760|Secondary|Time to Onset of Sustained Improvement in the 24-hour Average Pain Intensity Score|Sustained improvement in the 24-hour average pain intensity score is defined as at least 2 consecutive days on which the 24-hour average pain intensity score is >=2 points less than the mean 24-hour average pain intensity score at baseline. Time to onset is measured from baseline and was calculated as first day of event minus last day of baseline and is expressed in days. Baseline score is the calculated mean of the 24-hour average pain score for each participant during the last 7 days prior to randomization.|Any time post-baseline until date of last dose of study medication (up to Week 13)|ITT Population||days||Full Range|Median
761826|NCT00643760|Secondary|Number of Participants Achieving Various Levels of Percent Reduction From Baseline in the Mean 24-hour Average Pain Intensity Score at EOMT Using LOCF Data|Baseline and EOMT scores are the calculated means of the 24-hour average pain scores for each participant during the last 7 days prior to randomization and EOMT, respectively. Percent reduction from baseline was calculated as the [(EOMT score minus the baseline score)divided by the baseline score], multiplied by 100. The PI-NRS is an 11-point scale (0=no pain, 10=pain as bad as you can imagine) by which a participant assesses their 24-hour average pain intensity.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population||participants|||Number
761827|NCT00643760|Secondary|Number of Participants Who Are Responders on the Clinician Global Impression of Change (CGIC) Questionnaire at EOMT Using LOCF Data|"The CGIC is a single-item questionnaire designed to provide an overall assessment of treatment from the clinician's perspective since the start of the study. It is measured on a 7-point scale, where 1=very much improved and 7=very much worse. A participant is considered a responder if they have a response of very much improved or much improved. EOMT response is defined as the score recorded at the Week 13/Withdrawal visit."|EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. Not all participants had a CGIC assessment at Week 13/Withdrawal; as such, the number analyzed is different from the full ITT Population counts.||participants|||Number
761828|NCT00643760|Secondary|Number of Participants Who Are Responders on the Patient Global Impression of Change (PGIC) Questionnaire at EOMT Using LOCF Data|"The PGIC is a single-item questionnaire designed to provide an overall assessment of treatment from the participant's perspective since the start of the study. It is measured on a 7-point scale, where 1=very much improved and 7=very much worse. A participant is considered a responder if they have a response of very much improved or much improved. EOMT response is defined as the score recorded at the Week 13/Withdrawal visit."|EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. Not all participants completed a PGIC assessment at Week 13/Withdrawal; as such, the number analyzed is different from the full ITT Population counts.||participants|||Number
761829|NCT00643760|Secondary|Change From Baseline in Pain Score After Taking a 50-foot Walk at EOMT|Baseline and EOMT scores are the pain scores each participant reported after taking a 50-foot walk at the randomization and Week 13/Withdrawal visits, respectively, using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with BMI, baseline pain intensity after 50-foot walk, pain intensity prior to 50-foot walk at the visit being assessed, and grouped center as covariates was used.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. Not all participants completed a 50-foot walk at both Baseline and Week 13/Withdrawal; as such, the number analyzed is different from the full ITT Population counts.||scores on a scale||Standard Error|Least Squares Mean
761830|NCT00643760|Secondary|Change From Baseline in Pain Characteristics and Intensity as Assessed by the Short Form-McGill Pain Questionnaire (SF-MPQ) at EOMT Using LOCF Data|The SF-MPQ, a general pain instrument, assesses the characteristics and intensity of pain and consists of 15-items assessed on a 4-point scale (0=none, 1=mild, 2=moderate, and 3=severe). 3 summary scores are calculated: sensory score (sum of items 1-11, range 0-33), affective score (sum of items 12-15, range 0-12), total score (sum of items 1-15, range 0-45), where lower scores = lower pain/impact. Analysis is based on the change from baseline (BL) (EOMT score minus the BL score) using an ANCOVA model with BL value, BMI, grouped center as covariates.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. Not all participants completed an SF-MPQ assessment at both Baseline and Week 13/Withdrawal; as such, the number analyzed is different from the full ITT Population counts.||scores on a scale||Standard Error|Least Squares Mean
761850|NCT00644059|Secondary|Indirect Protective Effect of Fluad (NH Composition 2007/2008), Compared to Non-flu Control and Flu Control, in Connection to Household-contact Persons Via a Questioning of the Parents About ILI of Persons Living in the Same Household as the Study Child||3 weeks after 2nd vaccination|As per an amendment to the protocol, the Secondary efficacy endpoints were evaluated in enrolled subjects only and the household members were not included in the trial for the evaluation of indirect vaccine efficacy.|||||
761831|NCT00643760|Secondary|Change From Baseline in Pain Quality as Assessed by the Neuropathic Pain Scale (NPS) Summary Scores at EOMT Using LOCF Data|The NPS assesses pain qualities and consists of 11-items, 10 assessed on an 11-point NRS (0=no impact to 10=greatest impact); and 1 open-ended question not used in score calculation. 4 summary scores are calculated: NPS 10 (items 1-7, 9-11), NPS 8 (8 pain descriptor items), NPS Non-Allodynic (NA) (8 NA items), and NPS 4 (4 pain quality items); and range from 0 to 100 (0=no impact and 100=greatest impact). The analysis is based on the change from baseline (BL) (EOMT score minus the BL score) using an ANCOVA model with BL value, BMI, grouped center as covariates.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. Not all participants completed an NPS assessment at both Baseline and Week 13/Withdrawal; as such, the number analyzed is different from the full ITT Population counts.||scores on a scale||Standard Error|Least Squares Mean
761832|NCT00643760|Secondary|Change From Baseline in the Mean Daily Dose of Rescue Medication at EOMT Using LOCF Data|Mean daily use of rescue medication (milligrams of acetaminophen) was calculated by determining the average number of tablets taken per day of rescue medication (Commerical Tylenol) during treatment and multiplying that by 500 mg. Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population||milligrams||Standard Error|Least Squares Mean
761833|NCT00643760|Secondary|Change From Baseline in the Mean Sleep Interference Score at EOMT Using LOCF Data|Participants assessed sleep interference due to pain on a daily basis in the morning upon awakening using an 11-point NRS (0=pain does not interfere with sleep, 10=pain completely interferes with sleep). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. There were two participants in the GEn 3600 mg/day group who did not complete enough post-baseline morning diaries to calculate a night-time worst pain intensity score for the EOMT timepoint.||scores on a scale||Standard Error|Least Squares Mean
761834|NCT00643760|Secondary|Change From Baseline in the Mean Night-time Worst Pain Intensity Score at EOMT Using LOCF Data|Night-time worst pain is defined as the partipant's assessment of their worst pain between going to bed at night and rising in the morning. Participants recorded night-time worst pain in the morning upon awakening using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. There were two participants in the GEn 3600 mg/day group who did not complete enough post-baseline morning diaries to calculate a night-time worst pain intensity score for the EOMT timepoint.||scores on a scale||Standard Error|Least Squares Mean
761835|NCT00643760|Secondary|Change From Baseline in the Mean Day-time Worst Pain Intensity Score at EOMT Using LOCF Data|Day-time worst pain is defined as the partipant's assessment of their worst pain between rising in the morning and going to bed at night. Participants recorded day-time worst pain in the evening before bedtime using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population||scores on a scale||Standard Error|Least Squares Mean
761836|NCT00643760|Secondary|Change From Baseline in the Mean Current (Evening) Pain Intensity Score at EOMT Using LOCF Data|"Current pain is defined as the participant's assessment of pain intensity right now. Participants recorded their current evening pain intensity in the evening before bedtime using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used."|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population||scores on a scale||Standard Error|Least Squares Mean
761837|NCT00643760|Secondary|Change From Baseline in the Mean Current (Morning) Pain Intensity Score at EOMT Using LOCF Data|"Current pain is defined as the participant's assessment of pain intensity right now. Participants recorded their current morning pain intensity in the morning upon wakening using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used."|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. There were two participants in the GEn 3600 mg/day group who did not complete enough post-baseline morning diaries to calculate a current (morning) pain intensity score for the EOMT timepoint.||scores on a scale||Standard Error|Least Squares Mean
761838|NCT00643760|Secondary|Change From Baseline in the Mean Night-time Average Pain Intensity (API) Score at EOMT Using LOCF Data|Night-time is defined as the time between going to bed at night and rising in the morning. Participants recorded night-time API on a daily basis in the morning upon awakening using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. There were two participants in the GEn 3600 mg/day group who did not complete enough post-baseline morning diaries to calculate an average night-time pain intensity score for the EOMT timepoint.||scores on a scale||Standard Error|Least Squares Mean
761839|NCT00643760|Secondary|Change From Baseline in the Mean Day-time Average Pain Intensity (API) Score at EOMT Using LOCF Data|Day-time is defined as the time between rising in the morning and going to bed at night. Participants recorded day-time API on a daily basis in the evening before bedtime using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population||scores on a scale||Standard Error|Least Squares Mean
761840|NCT00643760|Primary|Change From Baseline in the Mean 24-hour Average Pain Intensity (API) Score at End of Maintenance Treatment (EOMT) Using Last Observation Carried Forward (LOCF) Data|Baseline and EOMT values are the calculated means of the daily 24-hour API scores for each participant during the last 7 days prior to randomization (Baseline) and the earliest date of Week 13 visit/Withdrawal visit/last dose of study drug (EOMT). Participants used a hand-held diary to rate their API over the preceding 24 hours, using an 11-point Pain Intensity Numerical Rating Scale (PI-NRS) (0=no pain, 10=pain as bad as you can imagine). LOCF was used if less than 4 days of diary data were provided. Change from baseline was calculated as the EOMT score minus the Baseline score.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population||scores on a scale||Standard Error|Least Squares Mean
761841|NCT00643851|Secondary|Adjusted Mean Change From Baseline in Total Body Weight (kg) in Subjects With Baseline Body Mass Index (BMI) ≥ 27 kg/m^2 at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 of the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing values at baseline and Week 24 (LOCF) in subjects with BMI ≥ 27 kg/m2||kg||Standard Error|Mean
761842|NCT00643851|Secondary|Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 of the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing values at baseline and Week 24 (LOCF)||kg||Standard Error|Mean
761843|NCT00643851|Secondary|Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) in Subjects With Baseline HbA1c ≥ 9% at Week 24 (Last Observation Carried Forward [LOCF])|HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 8, 12, 16, 20, and 24 in the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing values at baseline and Week 24 (LOCF) in subjects with baseline HbA1c ≥ 9%||% of hemoglobin||Standard Error|Mean
761844|NCT00643851|Secondary|Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Percent adjusted for baseline HbA1c. Therapeutic glycemic response is defined as HbA1c <7.0%. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin. Mean and standard error for percentage of participants estimated by modified logistic regression model.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing values at baseline and Week 24 (LOCF)||Percentage of participants||Standard Error|Mean
761845|NCT00643851|Secondary|Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Fasting plasma glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 in the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing FPG values at baseline and Week 24 (LOCF)||mg/dL||Standard Error|Mean
761846|NCT00643851|Primary|Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF])|HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 8, 12, 16, 20, and 24 in the double- blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing values at baseline and Week 24 (LOCF)||% of hemoglobin||Standard Error|Mean
761847|NCT00643916|Other Pre-specified|Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination.|Solicited local reactions: Redness, Swelling, and Tenderness. Solicited systemic reactions: Fever (temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability.|Day 0 up to 7 post-vaccination|Safety analysis was on all enrolled and vaccinated study participants, intent-to-treat population.||Percentage of participants|||Number
763759|NCT00671788|Secondary|Overall Survival||Every other cycle up to 5 years|Eligible and treated participants||months||95% Confidence Interval|Median
761852|NCT00644059|Secondary|Percentages of Subjects With Seroconversion and Vaccine Group Differences in Unprimed Subjects 6 to <72 Months of Age for Season 2008/09 (Homologous and Heterologous Strains)|"HI assay was used for the analysis. Seroconversion is defined as negative pre-vaccination serum (<10)/ post-vaccination HI titer ≥1:40.
Seroconversion is defined as either pre-vaccination HI titer <10 and a post-vaccination HI titer ≥1:40 or a prevaccination HI titer ≥10 and a minimum 4-fold rise in post-vaccination HI antibody titer. The lower bound of the two-sided 95% confidence interval (CI) for the percentage of subjects achieving seroconversion for HI antibody should meet or exceed 40%."|On study days 1, 29, 50, 181|The analysis was done on Full Analysis Set||Percentage of subjects||95% Confidence Interval|Number
761853|NCT00644059|Secondary|Percentages of Subjects With HI Titers ≥ 1:40 in Unprimed Subjects 6 to <72 Months of Age for Season 2008/09 Homologous and Heterologous Strains|"Hemagglutination Inhibition (HI) assay was used for the analysis.
Percentage of subjects achieving seroprotection (i.e., with HI titer ≥1:40) at study day 1, study day 29, study day 50 and a study day 181 and associated 95% Confidence Intervals. The lower bound of the two-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥1:40 should meet or exceed 70%."|On study days 1, 29, 50, 181|The analysis was done on Full Analysis Set||Percentage of subjects||95% Confidence Interval|Number
761854|NCT00644059|Secondary|Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMRs, in Unprimed Subjects Aged 6 to <72 Months for Season 2008/09 (Homologous and Heterologous Strains)|"Hemagglutination Inhibition (HI) assay was used for the analysis. Geometric mean titer ratios (GMRs) of study day 29/study day 1, study day 50/study day 1, study day 181/study day 1 were evaluated.
The criteria for evaluation is GMR >2.5"|On study days 1, 29, 50, 181|The analysis was done on Full Analysis Set||Ratios||95% Confidence Interval|Geometric Mean
761855|NCT00644059|Secondary|Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMTs, in Unprimed Subjects Aged 6 to <72 Months for Season 2008/09 (Homologous and Heterologous Strains)|Immunogenicity was analyzed in terms of Geometric Mean Titers (GMTs) as measured by hemagglutination inhibition (HI) assay. For each strain and each vaccine group, least squares GMTs, associated 2-sided 95% confidence interval were determined for all time points Superiority analysis: GMT-TIV-adj/GMT-Flu-control >1 and GMT-TIV-adj/GMT-Non Flu-control >1 should be elicited to show that GMT-TIV-adj is superior to GMT-Flu-control/Non Flu-control.|On study days 1, 29, 50 , 181|The analysis was done on Full Analysis Set||Titers||95% Confidence Interval|Geometric Mean
761856|NCT00644059|Secondary|Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains)|"HI assay was used for the analysis. Seroconversion is defined as negative pre-vaccination serum (<10)/ post-vaccination HI titer ≥1:40.
Seroconversion is defined as either pre-vaccination HI titer <10 and a post-vaccination HI titer ≥1:40 or a prevaccination HI titer ≥10 and a minimum four-fold rise in post-vaccination HI antibody titer.
The lower bound of the two-sided 95% confidence interval (CI) for the percentage of subjects achieving seroconversion for HI antibody should meet or exceed 40%."|On study days 1, 29, 50, 181|The analysis was done on Full Analysis Set||Percentage of subjects||95% Confidence Interval|Number
761857|NCT00644059|Secondary|Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With HI Titer ≥1:40 in Season 2008/09 HI Assay(Homologous and Heterologous Strains)|Percentage of subjects achieving seroprotection (i.e., with HI titer ≥1:40) at study day 1, study day 29, study day 50 and a study day 181 and associated 95% CI. The lower bound of the two-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥1:40 should meet or exceed 70%.|On study days 1, 29, 50, 181|The analysis was done on Full Analysis Set||Percentage of subjects||95% Confidence Interval|Number
761858|NCT00644059|Secondary|Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of Geometric Mean Titers (GMTs), in Unprimed Subjects Aged 6 to <36 Months for Season 2008/09 (Homologous and Heterologous Strains)|"Immunogenicity was analyzed in terms of Geometric Mean Titers (GMTs) as measured by hemagglutination inhibition (HI) assay. For each strain and each vaccine group, least squares GMTs, associated 2-sided 95% confidence interval were determined for all time points.
Superiority analysis: GMT-TIV-adj/GMT-Flu-control >1 should be elicited to show that GMT-TIV-adj is superior to GMT-Flu-control"|On study days 1, 29, 50 and 181|The analysis was done on Full Analysis Set||Titers||95% Confidence Interval|Geometric Mean
761859|NCT00644059|Secondary|Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMRs, in Unprimed Subjects Aged 6 to <36 Months or Season 2008/09 (Homologous and Heterologous Strains)|"The immunogenicity was assessed in terms of Geometric mean titer ratios (GMRs) of study day 29/study day 1, study day 50/study day 1, study day 181/study day 1 were evaluated.
The criteria for evaluation is GMR >2.5"|On study days 1, 29, 50 and 181|The analysis was done on Full Analysis Set||Ratios||95% Confidence Interval|Geometric Mean
761860|NCT00644059|Secondary|Number of Events of Influenza Like Illness for Combined Seasons 2007/08 and 2008/09.|The number of events of Influenza like Illness reported by subjects aged 6 to <72 months was assessed for combined seasons 2007/08 and 2008/09|3 weeks after 2nd vaccination|The analysis was done on Full Analysis Set||Events||Standard Deviation|Mean
761861|NCT00644059|Secondary|Loss of Days of Usual Activity (Job, School, Day Care, Household/Family/Community Activities) Due to Influenza Like Illness (ILI) in Subjects in Aged 6 to <72 and 6 to <36 Months and in Direct Caregivers Living in the Household.|Virus-confirmed influenza illnesses were assessed and trivalent adjuvanted influenza vaccine (TIV-adj) was compared with Non-flu control vaccine and Flu-control vaccine for Influenza like illnesses for seasons 2007/08 and 2008/09.|3 weeks after 2nd vaccination|The analysis was done on Full Analysis Set||Days||Standard Deviation|Mean
761862|NCT00644059|Secondary|Number of Subjects With Influenza Like Illnesses (ILIs) in the 6 to <36 Months and in Overall Age Cohort (Unprimed Subjects Aged 6 to <72 Months) for Combined Seasons 2007/08 and 2008/09|Virus-confirmed influenza illnesses were assessed and trivalent adjuvanted influenza vaccine (TIV-adj) was compared with Non-flu control vaccine and Flu-control vaccine for Influenza like illnesses for seasons 2007/08 and 2008/09.|3 weeks after 2nd vaccination|Analysis was done on Full Analysis Set||Number of subjects|||Number
761863|NCT00644059|Secondary|Number of Subjects (Unprimed) With Influenza Like Illnesses (ILIs) in the 6 to <72 Months Age Cohort for Combined Seasons 2007/08 and 2008/09|Virus-confirmed influenza illnesses were assessed and trivalent adjuvanted influenza vaccine (TIV-adj) was compared with Non-flu control vaccine and Flu-control vaccine in 6 to <72 month old subjects for Influenza like illnesses for seasons 2007/08 and 2008/09.|3 weeks after 2nd vaccination|Analysis was done on Full Analysis Set||Number of subjects|||Number
761864|NCT00644059|Secondary|Percentage of Subjects (Unprimed) Aged 6 to <72 Months With Virus-Confirmed Influenza, Comparison of aTIV to Non-flu Vaccine Control and Flu Vaccine Control (Any Strains).|"Virus-confirmed influenza illnesses (regardless of antigenic match to those contained in the vaccine) were assessed and compared between the adjuvanted influenza vaccine (TIV-adj) and non-influenza vaccines (Non-flu control) in subjects aged 6 to <72 months (unprimed) for Absolute Efficacy.
For Relative efficacy, the comparison was made between adjuvanted influenza vaccine (TIV-adj) and flu vaccine control."|3 weeks after 2nd vaccination|Analysis was done on Full Analysis Set||Percentage of subjects|||Number
761865|NCT00644059|Secondary|Percentage of Subjects (Unprimed) Aged 6 to <72 Months With Virus-Confirmed Influenza, Comparison of aTIV to Non-flu Vaccine Control and Flu-vaccine Control (Matched Strains)|"Virus-confirmed influenza illnesses were assessed and compared between the adjuvanted influenza vaccine (TIV-adj) and non-influenza vaccines (Non-flu control) in subjects aged 6 to <72 months (unprimed) for Absolute Efficacy.
For Relative efficacy, the comparison was made between adjuvanted influenza vaccine (TIV-adj) and flu vaccine control."|3 weeks after 2nd vaccination|The analysis was done on Full Analysis Set||Percentage of subjects|||Number
761866|NCT00644059|Secondary|Number of Subjects (Unprimed) With Unsolicited Adverse Events Reported After Any Vaccination|Number of subjects aged 6 to <36 months and in the overall age cohort (unprimed children aged 6 to <72 months) experiencing each of the unsolicited adverse events (AEs) throughout the study|Study day 1 to Study day 181|The analysis was done on Safety set||Number of subjects|||Number
761867|NCT00644059|Secondary|Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination|Safety was assessed as the number of subjects aged 6 to <72 months who reported solicited local or systemic adverse events after any vaccination with TIV-adj for all seasons.|7 days post-vaccination|The analysis was done on Safety set||Number of subjects|||Number
761868|NCT00644059|Primary|Percentage of Subjects (Unprimed) Aged 6 to <36 Months With Virus-Confirmed Influenza, Comparison of aTIV and Non-flu Vaccine Control (Men C/TBE Vaccine)|Virus-confirmed influenza illnesses were assessed and compared between the adjuvanted influenza vaccine (TIV-adj) and non-influenza vaccines (Non-flu control) in 6 to <36 month unprimed subjects for Absolute Efficacy. This primary endpoint is only for homologous strains.|3 weeks after 2nd vaccination|Analysis was done on Full Analysis Set (FAS) - All subjects in the enrolled set who received study vaccination and provided at least one evaluable serum sample both before and after baseline.||Percentage of subjects|||Number
761869|NCT00644059|Primary|Number of Subjects (Unprimed) 6 to <36 Months Age With Local and Systemic Reactions After Any Vaccination for All Seasons, Comparison of Adjuvanted Trivalent Influenza Vaccine (aTIV) and Flu Vaccine Control.|Safety was assessed in terms of number of subjects experiencing each of the local and systemic reactions within 7-days after any vaccination for all seasons, comparison of adjuvanted Trivalent influenza vaccine (aTIV) and flu vaccine control.|7 days post-vaccination|The analysis was done on Safety set - All subjects in the exposed population who provided post-baseline safety data.||Number of subjects|||Number
761870|NCT00644189|Secondary|Phase I Participants: Safety|Grade 2-4 toxicities and grade 3-4 infections among all phase I trial participants who are treated with any of the 4 dose levels of oral clofarabine (1mg, 2mg, 4mg, or 3mg)|during 6 28-day cycles and 90 days out|Phase I participants only||Participants|||Count of Participants
761871|NCT00644189|Secondary|All Phase I Participants: Overall Survival (OS)|Determine the overall survival rate among all phase I trial participants who are treated with any of the 4 dose levels of oral clofarabine (1mg, 2mg, 4mg, or 3mg)|at 17 months|Phase I participants only||percentage of participants||90% Confidence Interval|Mean
761872|NCT00644189|Secondary|Phase I Participants: Progression-free Survival (PFS)|"Determine the progression-free survival rate among all phase I trial participants who are treated with any of the 4 dose levels of oral clofarabine (1mg, 2mg, 4mg, or 3mg).
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions."|at 17 months|Phase I participants only||percentage of participants||90% Confidence Interval|Mean
761873|NCT00644189|Secondary|Phase I Participants Treated at the RP2D (3mg): Overall Response Rate (ORR)|"To determine the efficacy of oral clofarabine (3mg) in patients with relapsed/refractory non-Hodgkin lymphoma. The 3mg dose was declared the recommended phase 2 dose (RP2D) from phase I.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|after at most 6 28-day cycles|Phase I participants only who were treated at the RP2D (3mg)||Participants|||Count of Participants
761874|NCT00644189|Secondary|All Phase I-II Participants: Safety|Grade 3-4 toxicities among all phase I-II trial participants who are treated with any of the 4 dose levels of oral clofarabine (1mg, 2mg, 4mg, or 3mg)|during 6 28-day cycles and 90 days out|all phase I-II trial participants who are treated with any of the 4 dose levels of oral clofarabine||Participants|||Count of Participants
761875|NCT00644189|Secondary|All Phase I-II Participants: Overall Survival (OS)|Determine the overall survival rate among all phase I-II trial participants who are treated with any of the 4 dose levels of oral clofarabine (1mg, 2mg, 4mg, or 3mg)|3 years|all participants from phase I-II trial who are treated with any of the 4 dose levels of oral clofarabine||percentage of participants||95% Confidence Interval|Number
761876|NCT00644189|Secondary|All Phase I-II Participants: Progression-free Survival (PFS)|"Determine the progression-free survival rate among all phase I-II trial participants who are treated with any of the 4 dose levels of oral clofarabine (1mg, 2mg, 4mg, or 3mg).
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions."|at 1 and 2 years|all participants from phase I-II trial who are treated with any of the 4 dose levels of oral clofarabine||percentage of patients||95% Confidence Interval|Number
761890|NCT00644332|Secondary|Determine the Effect of Ranolazine on Angina Frequency as Measured by Patient-reported Diaries|Angina episodes were recorded by subjects in their diaries. Weekly frequency of angina episodes was calculated for the two-week baseline period and the last two weeks of the study.|Baseline to Week 4|"Modified Intent-to-Treat Analysis Set
Missing values were excluded"||attacks per week||Standard Error|Mean
761877|NCT00644189|Secondary|Phase I-II Participants Treated at the RP2D (3mg): Overall Response Rate (ORR)|"To determine the efficacy of oral clofarabine (3mg) in patients with relapsed/refractory non-Hodgkin lymphoma. The 3mg dose was declared the recommended phase 2 dose (RP2D) from phase I.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|after at most 6 28-day cycles|only participants from phase I-II trial who were treated at the RP2D (3mg)||percentage of participants||95% Confidence Interval|Number
761878|NCT00644189|Primary|Phase I Participants Only: Overall Response Rate (ORR)|"Determine the efficacy of oral clofarabine (any of the 4 dose levels: 1mg, 2mg, 4mg, and 3mg) in all phase I trial patients with relapsed/refractory non-Hodgkin lymphomas.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|after at most 6 28-day cycles|Phase I participants only||percentage of participants||90% Confidence Interval|Mean
761879|NCT00644189|Primary|All Phase I-II Participants: Overall Response Rate (ORR)|"Determine the efficacy of oral clofarabine (any of the 4 dose levels: 1mg, 2mg, 4mg, and 3mg) in all phase I-II trial patients with relapsed/refractory non-Hodgkin lymphomas.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|after at most 6 28-day cycles|all participants from phase I-II trial who are treated with any of the 4 dose levels of oral clofarabine||percentage of participants||95% Confidence Interval|Number
761880|NCT00644228|Secondary|Response Rates ()|The response rate was calculated as the number of patients with documented confirmed partial response (PR) or better, which includes confirmed/unconfirmed stringent complete response (sCR), confirmed/unconfirmed complete response (CR), confirmed/unconfirmed very good partial response (VGPR), or confirmed partial response (PR), as best response divided by the total number of evaluable patients, in each arm. Patients with measurable disease, as defined in the protocol, are evaluable. Response rates were compared between the two treatment arms using a stratified Cochran-Mantel-Haenszel test. Response designations were based on the International Uniform Response Criteria for Multiple Myeloma. Due to the complexity of these criteria, the details of these criteria have been omitted.|Up to 6 years|All eligible, analyzable patients are included.||Participants|||Count of Participants
761881|NCT00644228|Secondary|Overall Survival|Unstratified median overall survival in months.|Up to 6 years|All eligible and analyzable patients are included. An analyzable patient is one who provided valid consent and who did not withdraw consent prior to initiating treatment.||Months||95% Confidence Interval|Median
761882|NCT00644228|Primary|Progression-free Survival|Unstratified median progression-free survival in months.|From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 6 years|All eligible and analyzable patients are included. An analyzable patient is one who provided valid consent and who did not withdraw consent prior to initiating treatment.||Months||95% Confidence Interval|Median
761883|NCT00644280|Secondary|Significant Ocular Adverse Events|Participants experiencing significant ocular adverse events, including endophthalmitis and rhegmatogenous retinal detachment|6 months|||participants|||Number
761884|NCT00644280|Primary|Tube Success at 6 Months|Criteria for success at 6 months postoperatively was intraocular pressure (IOP) < 18mmHg without the necessity for adjunctive medication for pressure or IOP < 15mmHg with <=1 adjunctive medication.|6 months|||percentage of participants|||Number
761885|NCT00644332|Secondary|Evaluate the Degree of Correlation Between Changes From Baseline in Items of the WISQ and SAQ With Changes From Baseline in Angina Frequency and NTG Diary Data and the DASI|The DASI is a self-administered questionnaire that measures a patient's functional capacity. It can be used to get a rough estimate of a patient's peak oxygen uptake. The maximum score for the DASI is 58.2 (better functional ability/capacity) and the minimum score is 0 (worse functional ability/capacity). The planned analysis was the amount of variation in WISQ and SAQ score changes from baseline explained by changes in angina frequency, NTG use, and DASI score assessed by multiple linear regression analysis.|Baseline to Week 4|Data was collected for this outcome, however, the analysis was not done.||coefficient of determination|||Number
761886|NCT00644332|Primary|Evaluate the Responsiveness of the WISQ in Women With Chronic Angina Based on Changes in Patient-reported Angina Frequency and NTG Consumption Before and Following Treatment With Ranolazine Assessed by Regression Analysis|Responsiveness of the WISQ was assessed as the estimated coefficient of determination (R^2) of the change from baseline WISQ Total Score at 4 weeks regressed on change from baseline angina frequency and change from baseline NTG use. For mean (SEM) Baseline and Week 4 values for angina frequency and NTG use, please refer to Secondary Outcome Measures 7 and 8.|Baseline to Week 4|Modified Intent-to-Treat Analysis Set||coefficient of determination|||Number
761887|NCT00644332|Primary|Evaluate the Reliability of the WISQ in Women With Chronic Angina Based on Changes in Patient-reported Angina Frequency and NTG Consumption Before and Following Treatment With Ranolazine Assessed as Cronbach's Alpha Value|Reliability of the WISQ was assessed by estimating Cronbach's alpha (standardized); values of 0.7 or higher were to be considered adequate. (Standardized Cronbach's alpha is a coefficient of reliability or consistency, and is a function of the average inter-item correlation.) Cronbach's alpha was calculated for the WISQ instrument overall and for the Angina Frequency/Severity and Angina Stability subscales. Missing item responses were not imputed.|Baseline to Week 4|Modified Intent-to-Treat Analysis Set||ratio of variances|||Number
761888|NCT00644332|Secondary|Determine Changes From Baseline in the Duke Activity Status Index (DASI) Following Ranolazine Treatment|The DASI was analyzed as mean values at baseline and Week 4. The DASI is a self-administered questionnaire that measures a patient's functional capacity. It can be used to get a rough estimate of a patient's peak oxygen uptake. The maximum score for the DASI is 58.2 (better functional ability/capacity) and the minimum score is 0 (worse functional ability/capacity).|Baseline to Week 4|Modified Intent-to-Treat Analysis Set||DASI scale units||Standard Error|Mean
762540|NCT00653224|Secondary|Ocular Itching/Burning Score Over the First Week|The ocular itching/burning score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided.|Over week 1|Number of participants from the ITT population with available ocular itching/burning score over Week 1||points on a scale||Standard Deviation|Mean
761891|NCT00644332|Primary|Evaluate the Validity of the WISQ in Women With Chronic Angina Based on Changes in Patient-reported Angina Frequency and Nitroglycerin (NTG) Consumption Before and Following Treatment With Ranolazine Assessed as Coefficient of Determination (R^2)|Validity of the WISQ was assessed by regression analysis. Results of this analysis are reported as the estimated coefficient of determination (R^2) of the WISQ Total Score at 4 weeks regressed on 4-week angina frequency, 4-week NTG use, and DASI score at 4 weeks. For mean (SEM) Baseline and Week 4 values for angina frequency and NTG use, please refer to Secondary Outcome Measures 7 and 8. For mean (SEM) Baseline and Week 4 DASI values, please refer to Secondary Outcome Measure 9.|Baseline to Week 4|Modified Intent-to-Treat Analysis Set, defined as all patients who took at least 1 dose of ranolazine and completed both baseline and postbaseline questionnaires. Partially missing questionnaire responses were imputed by the methods specified in the scoring instructions; completely missing responses were not imputed.||coefficient of determination|||Number
761892|NCT00644332|Secondary|Compare Changes From Baseline (BL) in Other Like Items of the WISQ With the SAQ Following Ranolazine Treatment|Changes from BL in stress, excitement, temperature, satiety, anger, and other limitation items following ranolazine treatment were measured. Analysis: multiple linear regression; response variable: ΔWISQ – ΔSAQ; independent variables: age and BL WISQ and SAQ scores. WISQ items: 27 points (higher=more severe state); SAQ items: 45 points (lower=more severe state). WISQ scores were recalibrated by multiplying by 15/27. Noninferiority was to be considered demonstrated if the lower limit of a 2-sided 95% CI for WISQ mean – SAQ mean was above the prespecified margin (WISQ vs SAQ difference of -2).|Baseline to 4 Weeks|Modified Intent-to-Treat Analysis Set||SAQ scale units||95% Confidence Interval|Number
761893|NCT00644332|Secondary|Compare Changes From Baseline (BL) in the Physical Limitation Items of the WISQ With the SAQ Following Ranolazine Treatment|Changes from BL in stress, excitement, temperature, satiety, anger, and other limitation items following ranolazine treatment were measured. Analysis: multiple linear regression; response variable: ΔWISQ – ΔSAQ; independent variables: age and BL WISQ and SAQ scores. WISQ items: 27 points (higher=more severe state); SAQ items: 45 points (lower=more severe state). WISQ scores were recalibrated by multiplying by 15/27. Noninferiority was to be considered demonstrated if the lower limit of a 2-sided 95% CI for WISQ mean – SAQ mean was above the prespecified margin (WISQ vs SAQ difference of -2).|Baseline to 4 Weeks|Modified Intent-to-Treat Analysis Set||SAQ scale units||95% Confidence Interval|Number
761894|NCT00644332|Secondary|Determine Whether the WISQ is Noninferior to the Seattle Angina Questionnaire (SAQ) With Regard to Angina Frequency Items Based on Changes From Baseline (BL) in the Angina Frequency Items of the WISQ With the SAQ Following Ranolazine Treatment|Changes from BL in angina frequency items following ranolazine treatment were measured. Analysis: multiple linear regression; response variable: ΔWISQ – ΔSAQ; independent variables: age and BL WISQ and SAQ scores. WISQ items: 15 points (higher=more severe state); SAQ items: 12 points (lower=more severe state). WISQ scores were recalibrated by multiplying by .75. Noninferiority was to be considered demonstrated if the lower limit of a 2-sided 95% CI for WISQ mean – SAQ mean was above the prespecified margin (WISQ vs SAQ difference of -2).|Baseline to 4 Weeks|Modified Intent-to-Treat Analysis Set||ratio of variance||95% Confidence Interval|Number
761895|NCT00644358|Secondary|Clinical Global Impression - Improvement (CGI-I) Score|The CGI-I is a clinician-rated scale for assessing improvement of a patient’s condition, using a 7-point scale where 1=very much improved (best) and 7=very much worse.|Weeks 1, 2, 3, 4, 6 ,8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52/Early Termination|Effectiveness Population consisted of all participants who took at least one dose, and had at least one post-baseline efficacy endpoint measurement. The number analyzed for each category row is the number of participants with available data at the given time-point.||score on a scale||Standard Deviation|Mean
761896|NCT00644358|Secondary|Change From Baseline in Clinical Global Impressions - Severity (CGI-S) Score|The CGI-S is a clinician-rated scale that measures global severity of illness at a given point in time using a 7-point scale where 1=normal, not at all ill, and 7=among the most severely ill. A negative change from Baseline indicates improvement.|Baseline and Weeks 1, 2, 3, 4, 6 ,8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52/Early Termination|Effectiveness Population consisted of all participants who took at least one dose, and had at least one post-baseline efficacy endpoint measurement. The number analyzed for each category row is the number of participants with available data at the given time-point.||score on a scale||Standard Deviation|Mean
761897|NCT00644358|Secondary|Change Form Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score|The MADRS is a clinician-rated scale for assessing depressive symptomatology that had occurred in participants during the week preceding each interview. Participants were rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest. Each item was scored on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score was the sum of the scores on the 10 items and ranged from 0 to 60. A higher score indicated more depressive symptomatology. A negative change score indicated improvement.|Baseline and Weeks 1, 2, 3, 4, 6 ,8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52/Early Termination|Effectiveness Population consisted of all participants who took at least one dose, and had at least one post-baseline efficacy endpoint measurement. The number analyzed for each category row is the number of participants with available data at the given time-point.||score on a scale||Standard Deviation|Mean
761898|NCT00644358|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|An Adverse Event (AE) is any untoward medical occurrence in a clinical study participant administered study drug. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not related to the medicinal product. An AE that occurred during the treatment period was defined as a TEAE if the AE was either not present at, or before, the day of the first dose of study medication or was present at, or before, the day of the first dose of study medication and increased in severity during the treatment period. AEs included abnormal clinically significant findings for laboratory parameters, physical examinations, vital signs, weight, electrocardiograms (ECGs), the Change in Sexual Functioning Questionnaire (CSFQ), ophthalmologic exams and the Columbia-Suicide Severity Rating Scale (C-SSRS).|From first dose of study medication and up to 30 days after the last dose of study medication (Up to 13 months)|Safety population consisted of enrolled participants who took at least 1 dose of study drug and had at least 1 post-baseline safety measurement.||Participants|||Number
761899|NCT00644592|Primary|Log(ENA-Period 2 End/ENA Period 1 End)|"Log of the ratio of Period end ENA-78 Period 2:Period 1. Once the confidence interval is obtained, we take antilogs to obtain a ratio of effects.
Natural logs used"|week 12 to week 4|Intent was to enroll 30 but drug was withdrawn by provider, with only 11 completing both experimental periods||Log of Ratio||Standard Deviation|Mean
761900|NCT00644657|Secondary|The Percentage of Coated Platelets After Coronary Angiography and/or PCI|The percentage of coated platelets 24 hours after coronary angiography and/or PCI|6 hrs after procedure|||Percentage of platelets that are coated||Standard Deviation|Mean
761901|NCT00644657|Primary|The Percentage of Coated Platelets After the Administration of Clopidogrel in Patients Undergoing Cardiac Catheterization and/or Angioplasty|The percentage of platelets that are collagen coated after the administration of clopidogrel.|24 hours after the administration of clopidotrel|||Percent of platelets that are coated.||Standard Deviation|Mean
761902|NCT00644787|Secondary|Number of Participants With Response Based on Physician’s Global Assessment Scale in Double Blind Phase|The treating physician assessed the therapeutic efficacy of the study drug to control pain on a 2-point scale of effective and ineffective. Number of participants with effective and ineffective therapeutic efficacy with respect to the study drug were reported.|Day 10|The PPS population included all the participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug excluding those with any major protocol deviation or other violations. 'n' signifies those participants who were evaluable for this measure at given time points.||Percentage of participants|||Number
761903|NCT00644787|Secondary|Number of Participants With Response Based on Physician’s Global Assessment Scale in Titration Phase|The treating physician assessed the therapeutic efficacy of the study drug to control pain on a 2-point scale of effective and ineffective. Number of participants with effective and ineffective therapeutic efficacy with respect to the study drug were reported.|Day 14|The FAS population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||Participants|||Number
761904|NCT00644787|Secondary|Mean Number of Rescue Doses in Double Blind Phase|Rescue dose was defined as dose of a fast-acting oral morphine hydrochloride solution or morphine in water solution used in the case of breakthrough pain or lack of analgesic effect.|Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9 and Day 10 or ED|The PPS population included all the participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug excluding those with any major protocol deviation or other violations. 'n' signifies those participants who were evaluable for this measure at given time points.||Rescue doses||Standard Deviation|Mean
761905|NCT00644787|Secondary|Mean Number of Rescue Doses in Titration Phase|Rescue dose was defined as dose of a fast-acting oral morphine hydrochloride solution or morphine in water solution used in the case of breakthrough pain or lack of analgesic effect.|Day 1 PA, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12, Day 13 and Day 14 or ED|The FAS population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug. 'n' signifies those participants who were evaluable for this measure at given time points.||Rescue doses||Standard Deviation|Mean
761906|NCT00644787|Secondary|Number of Participants With Total Duration of Pain Per Day in Double Blind Phase|The participants assessed total painful time in 1 day on a 5-point scale ranging from 0 to 4 where 0 = less than (<) 4 hours, 1 = greater than or equal to (>=) 4 hours to less than 8 hours, 2 = greater than or equal to 8 hours to less than 12 hours, 3 = greater than or equal to 12 hours and 4 = 24 hours (all day).|Day 14-End of Titration Phase (ETP), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9 and Day 10 or ED|The PPS population included all the participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug excluding those with any major protocol deviation or other violations. 'n' signifies those participants who were evaluable for this measure at given time points.||Participants|||Number
761907|NCT00644787|Secondary|Number of Participants With Total Duration of Pain Per Day in Titration Phase|The participants assessed total painful time in 1 day on a 5-point scale ranging from 0 to 4 where 0 = less than (<) 4 hours, 1 = greater than or equal to (>=) 4 hours to less than 8 hours, 2 = greater than or equal to 8 hours to less than 12 hours, 3 = greater than or equal to 12 hours and 4 = 24 hours (all day).|Day 1 PA, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12, Day 13 and Day 14 or ED|The FAS population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug. 'n' signifies those participants who were evaluable for this measure at given time points.||Participants|||Number
761908|NCT00644787|Secondary|Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase|Participants were asked to assess their resting pain intensity (severity of pain) on a 4-point categorical scale ranging from 0 to 3 where 0 = no pain, 1 = mild pain, 2 = moderate pain and 3 = severe pain.|Day 14-End of Titration Phase (ETP), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9 and Day 10 or ED|The PPS population included all the participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug excluding those with any major protocol deviation or other violations. 'n' signifies those participants who were evaluable for this measure at given time points.||Participants|||Number
761909|NCT00644787|Secondary|Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase|Participants were asked to assess their resting pain intensity (severity of pain) on a 4-point categorical scale ranging from 0 to 3 where 0 = no pain, 1 = mild pain, 2 = moderate pain and 3 = severe pain.|Day 1 PA, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12, Day 13 and Day 14 or ED|The FAS population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug. 'n' signifies those participants who were evaluable for this measure at given time points.||Participants|||Number
761920|NCT00638690|Secondary|Number of Patients Achieving a Prostate-Specific Antigen Decline >=50%|A prostate-specific antigen (PSA) response was defined as a >=50% decline from baseline.|Up to 12 months|Analysis was performed on the Intent-to-Treat (ITT) population. The ITT population is composed of all patients randomized into the study and who will be classified according to their assigned teatment group, regardless of the actual treatment received.||Participants|||Number
761910|NCT00644787|Secondary|Percentage of Participants Achieving Pain Control in Double Blind Phase|Pain control was assessed based on change in VAS and number of daily rescue doses during 3 days before completion of Double Blind Phase from 3 days before start of Double Blind Phase. For VAS score, difference of less than or equal to +15 mm and for rescue doses, difference of less than or equal to 1 was considered significant to achieve pain control. Pain Intensity VAS measured pain severity on a scale ranging from 0 mm (no pain) to 100 mm (severest pain conceivable) and rescue dose was defined as dose of fast-acting oral morphine formulation used in case of breakthrough pain.|Day 10 or ED|The PPS population included all the participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug excluding those with any major protocol deviation or other violations.||Percentage of participants||95% Confidence Interval|Number
761911|NCT00644787|Secondary|Pain Intensity Visual Analog Scale (VAS) Score in Double Blind Phase|Participants were asked to assess their resting pain intensity (severity of pain) on a 100-mm VAS with the left edge (0 mm) defined as “no pain” and the right edge (100 mm) defined as “severest pain conceivable”.|Day 14-End of Titration Phase (ETP), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9 and Day 10 or ED|The PPS population included all the participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug excluding those with any major protocol deviation or other violations. 'n' signifies those participants who were evaluable for this measure at given time points.||mm||Standard Deviation|Mean
761912|NCT00644787|Secondary|Pain Intensity Visual Analog Scale (VAS) Score in Titration Phase|Participants were asked to assess their resting pain intensity (severity of pain) on a 100-mm VAS with the left edge (0 mm) defined as “no pain” and the right edge (100 mm) defined as “severest pain conceivable”.|Day 1 PA, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12, Day 13 and Day 14 or ED|The FAS population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug. 'n' signifies those participants who were evaluable for this measure at given time points.||mm||Standard Deviation|Mean
761913|NCT00644787|Secondary|Number of Participants With Response Based on Participant’s Global Assessment Scale in Double Blind Phase|Participants were asked to assess their satisfaction with respect to the therapeutic efficacy of the study drug to control pain on a 5-point scale ranging from 1 to 5, where 1 = extremely satisfied, 2 = satisfied, 3 = neither satisfied nor dissatisfied, 4 = dissatisfied and 5 = extremely dissatisfied.|Day 14-End of Titration Phase (ETP), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9 and Day 10 or ED|The PPS population included all the participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug excluding those with any major protocol deviation or other violations. 'n' signifies those participants who were evaluable for this measure at given time points.||Participants|||Number
761914|NCT00644787|Secondary|Number of Participants With Response Based on Participant’s Global Assessment Scale in Titration Phase|Participants were asked to assess their satisfaction with respect to the therapeutic efficacy (effectiveness) of the study drug to control pain on a 5-point scale ranging from 1 to 5, where 1 = extremely satisfied, 2 = satisfied, 3 = neither satisfied nor dissatisfied, 4 = dissatisfied and 5 = extremely dissatisfied.|Day 1 pre-application (PA), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12, Day 13 and Day 14 or ED|The FAS population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug. 'n' signifies those participants who were evaluable for this measure at given time points.||Participants|||Number
761915|NCT00644787|Primary|Change From Dose Titration Phase in the Mean Visual Analog Scale (VAS) Score at Double Blind Phase|The mean VAS score for the last 3 days before the completion or discontinuation of Double Blind Phase was compared with that for the last 3 days before the completion or discontinuation of Dose Titration Phase and the change from Dose Titration Phase in the mean VAS Score at Double Blind Phase was reported. Pain Intensity VAS measured severity of pain on a 100 mm scale ranging from 0 mm (no pain) to 100 mm (severest pain conceivable).|Dose Titration Phase (Day 12 to Day 14) and Double Blind Phase (Day 8 to Day 10)|Per Protocol Set (PPS) population included all the participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug excluding those with any major protocol deviation or other violations.||mm||Standard Deviation|Mean
761916|NCT00644787|Primary|Percentage of Participants Achieving Dose Titration Success|Participants achieving dose titration success included all participants who had a mean Visual Analog Scale (VAS) score of less than or equal to 34 millimeter (mm) and received not more than 2 rescue doses during the last 3 days before the completion or discontinuation of dose titration phase. Pain Intensity VAS measured severity of pain on a 100 mm scale ranging from 0 mm (no pain) to 100 mm (severest pain conceivable) and rescue dose was defined as dose of a fast-acting oral morphine hydrochloride solution or morphine in water solution used in the case of breakthrough pain.|Day 14 or early discontinuation (ED)|Full Analysis Set (FAS) population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug.||Percentage of participants||95% Confidence Interval|Number
761917|NCT00644917|Primary|Skin Reaction Score|Scores for phototoxic skin irritation were used to evaluate safety. In this study, irritation was graded using a scale that ranged from 0 (no reaction) to 7 (large vesiculo-bullous reaction) in whole units.|48 hours|Intent-to-Treat (ITT)||units on a scale||Standard Deviation|Mean
761918|NCT00638651|Primary|Efficacy of Tattoo Removal Using Topical Imiquimod 5% Cream|To evaluate the efficacy of tattoo removal using topical imiquimod, 5% cream (Aldara™, 3M/Graceway Pharmaceuticals, an immune response modifier) in conjunction with the 1064 nm Nd:YAG laser. This procedure for tattoo removal will be compared to laser removal alone.|approximately 14 weeks|||percentage of tattoo pigment removed|Tattoo|Full Range|Mean
761919|NCT00638690|Secondary|Radiographic Progression-free Survival|Radiographic progression-free survival is based on imaging studies according to modified Response Evaluation Criteria in Solid Tumors (RECIST): baseline lymph node size must be >=2.0 cm to be considered a target lesion; progression on bone scans with >=2 new lesions not consistent with tumor flare, confirmed on a second scan >=6 weeks later that shows >=1 additional new lesion.|Up to 11 months|Analysis was performed on the Intent-to-Treat (ITT) population. The ITT population is composed of all patients randomized into the study and who will be classified according to their assigned teatment group, regardless of the actual treatment received.||Days||95% Confidence Interval|Median
761921|NCT00638690|Secondary|Time to Prostate-Specific Antigen Progression According to Prostate Specific Antigen Working Group Criteria|The time interval from the date of randomization to the date of the prostate-specific antigen (PSA) progression as defined in the protocol-specific Prostate Specific Antigen Working Group (PSAWG) criteria, namely, a PSA level of at least 5 ng/ml that has risen on at least 2 successive occasions, at least 2 weeks apart.|Up to 12 months|Analysis was performed on the Intent-to-Treat (ITT) population. The ITT population is composed of all patients randomized into the study and who will be classified according to their assigned teatment group, regardless of the actual treatment received.||Days||95% Confidence Interval|Median
761922|NCT00638690|Primary|Overall Survival|Overall survival is defined as the time interval from the date of randomization to the date of death from any cause.|Up to 60 months|Analysis was performed on the Intent-to-Treat (ITT) population. The ITT population is composed of all patients randomized into the study and who will be classified according to their assigned teatment group, regardless of the actual treatment received.||Days||95% Confidence Interval|Median
761923|NCT00638716|Secondary|Reduction in Fasting Body Weight From Baseline|Change from Baseline|Screening and Day 85|Modified Intent-to-Treat Population||kg||Standard Deviation|Mean
761924|NCT00638716|Secondary|Reduction in FPG From Baseline|Change from Baseline|Screening and Day 85|Modified Intent-to-Treat Population||mg/dL||Standard Deviation|Mean
761925|NCT00638716|Primary|Reduction of HbA1c From Baseline|Change from Baseline|Screening and Day 85|Modified Intent-to-Treat Population||Percent (%)||Standard Deviation|Mean
761926|NCT00638820|Secondary|Differential Imaging and Biologic Evaluations|These outcome measures were not assessed due to early study termination.|Day 100, 6 months, 1, 2 and 5 years|||Participants|||Number
761927|NCT00638820|Secondary|Number of Patients With Transplant Related Toxicity|Number of patients experiencing adverse effects due to transplant categorized by body system using Common Terminology Criteria for Adverse Events coding from the National Cancer Institute, Version 3.0.|Day 100|||Participants|||Number
761928|NCT00638820|Secondary|Number of Patients With Transplant Related Death|Number of participants died during study by Day 100 and reason for death was related to transplant.|Day 100|||Participants|||Number
761929|NCT00638820|Primary|Number of Patients Achieving Donor Cell Engraftment|Number of patients with persistent presence of donor-derived cells at Day 100|Day 100|||Participants|||Number
761930|NCT00638846|Primary|Subjective Comfort|Subjective comfort was derived from a weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response. >0 = comfortable, < 0 = uncomfortable. Combined measures from Week 1 and Week 5.|2 weeks of lens wear|Analysis was performed on participants who completed the study per protocol.||units on a scale||Standard Error|Least Squares Mean
761931|NCT00638846|Secondary|Overall Corneal Staining|National Eye Institute 0-3 Scale: Grade 0 = Normal, Grade 1 = Mild, superficial stippling, Grade 2 = Moderate, punctuate staining including superficial abrasion of the cornea, Grade 3 = Severe, abrasion or corneal erosion, deep corneal abrasion or recurrent erosion.|After 2 weeks use|Analysis was performed on participants who completed the study per protocol.||units on a scale||Standard Error|Least Squares Mean
761932|NCT00638846|Secondary|Subjective Lens Vision|A weighted combined score calculated from individual vision-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response was used to derive vision outcomes. >0 = satisfactory vision, < 0 = unsatisfactory vision. Analysis is performed on combined 1 week and 2 week data.|measured at 1 and 2 weeks|Analysis was performed on participants who completed the study per protocol.||units on a scale||Standard Error|Least Squares Mean
761933|NCT00638846|Secondary|Time to Fit Lens|Time required for the optometrist to fit the lens.|after lens insertion|Analysis was performed on participants who completed the study per protocol.||minutes||Standard Error|Least Squares Mean
761934|NCT00638846|Primary|Lens Stability|Lens stability is measured as the amount of rotation induced from blink after the lens has settled.|10-15 minutes after insertion|Analysis was performed on participants who completed the study per protocol.||proportion of eyes|Participants||Number
761935|NCT00638846|Primary|Lens Orientation|Proportion of eyes with lens orientation within 5 degrees of optimal|1 minute after insertion|Analysis was performed on participants who completed the study per protocol. The data represents 274 eyes that wore senofilcon A lenses and 278 eyes that wore balafilcon A lenses.||proportion of eyes|Participants||Number
761936|NCT00638885|Primary|Neuropsychological Testing of Memory|Percent retention on the Wechsler Memory Scale - Logical|2 days|||percentage of WMS retention||Standard Deviation|Mean
761937|NCT00644969|Secondary|Change From Baseline to Week 12 and Week 24 in the Number of Cigarettes Smoked Per Day|Measured as mean number of cigarettes smoked per day averaged over the past 7 days at Week 12 and Week 24.|Baseline, Week 12, Week 24|FAS; (n)=number of participants with evaluable data at observation.||cigarettes per day||95% Confidence Interval|Least Squares Mean
761938|NCT00644969|Secondary|Number of Participants With at Least a 50 Percent (%) Reduction From Baseline to Week 12 and Week 24 in the Number of Cigarettes Smoked Per Day|Measured as at least a 50% reduction from baseline in cigarettes smoked per day averaged over the past 7 days at Week 12 and Week 24.|Baseline, Week 12, Week 24|FAS||participants|||Number
761939|NCT00644969|Secondary|Number of Participants With 7-day Point Prevalence of Non-smoking at Week 24|7-day point prevalence of non-smoking measured as the number of participants who maintained complete abstinence from cigarette smoking or other nicotine use in the previous 7 days before the Week 24 visit and had an end-expiratory carbon monoxide (CO) measurement of ≤10 parts per million (ppm).|Week 24|FAS||participants|||Number
761940|NCT00644969|Secondary|Number of Participants With 7-day Point Prevalence of Non-smoking at Week 12|7-day point prevalence of non-smoking measured as the number of participants who maintained complete abstinence from cigarette smoking or other nicotine use in the previous 7 days before the Week 12 visit and had an end-expiratory carbon monoxide (CO) measurement of ≤10 parts per million (ppm).|Week 12|Full analysis set (FAS): all participants randomized into the study who received at least 1 dose of study treatment (formerly referred to as the All subjects analysis set).||participants|||Number
761987|NCT00645099|Secondary|Change From Baseline to End Point in Converted Insulin|The insulin level was assessed under fasted conditions.|Baseline to End Point (up to 6 months)|Safety data were analyzed using the ITT analysis set for safety and consisted of 459 patients, i.e., all patients who received study medication at least once and provided any post-baseline safety data. Changes from baseline could only be calculated for patients with paired data.||pmol/L||Standard Deviation|Mean
761941|NCT00644969|Primary|Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 24|CGI-I: 7-point clinician rated scale ranging from 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, to 7=very much worse. Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Scores above 4 reflect worsening of illness state as compared to baseline.|Baseline, Week 24|Safety analysis set; N=number of participants with analyzable data at observation.||participants|||Number
761942|NCT00644969|Primary|Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 12|CGI-I: 7-point clinician rated scale ranging from 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, to 7=very much worse. Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Scores above 4 reflect worsening of illness state as compared to baseline.|Baseline, Week 12|Safety analysis set; N=number of participants with analyzable data at observation.||participants|||Number
761943|NCT00644969|Primary|Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 1|CGI-I: 7-point clinician rated scale ranging from 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, to 7=very much worse. Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Scores above 4 reflect worsening of illness state as compared to baseline.|Baseline, Week 1|Safety analysis set; N=number of participants with analyzable data at observation.||participants|||Number
761944|NCT00644969|Primary|Number of Participants With Shift From Baseline to Week 24 in Clinical Global Impressions Scale-Severity (CGI-S) Score|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1=normal, not ill at all, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill patients. Higher scores reflect higher severity of current illness states.|Baseline to Week 24|Safety analysis set; N=number of participants with evaluable data at observation.||participants|||Number
761945|NCT00644969|Primary|Number of Participants With Shift From Baseline to Week 12 in Clinical Global Impressions Scale-Severity (CGI-S) Score|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1=normal, not ill at all, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill patients. Higher scores reflect higher severity of current illness states.|Baseline (Bsl) to Week 12|Safety analysis set; N=number of participants with evaluable data at observation.||participants|||Number
761946|NCT00644969|Primary|"Number of Participants With Suicidal Behavior or Suicical Ideation (Yes Response ) on the Columbia Suicide-Severity Rating Scale (C-SSRS) During the Post Treatment Phase"|"C-SSRS is a clinician rated assessment of suicidal behavior and / or intent categorized as: Suicidal behavior=a yes response to any of 5 suicidal behavior questions (preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide); Suicidal ideation=a yes response to any one of 5 suicidal ideation questions which includes wish to be dead, and 4 different categories of active suicidal ideation (thought, thought with method, thought with intent, thought with plan and intent)."|Week 13 to Week 24 (Post treatment phase)|"Safety analysis set; N=number of participants assessed for suicidal behavior and / or ideation. Yes response includes participants with new suicidal behavior and / or ideation."||participants|||Number
761947|NCT00644969|Primary|"Number of Participants With Suicidal Behavior and / or Ideation (Yes Response) on the Columbia Suicide Severity Rating Scale (C-SSRS) During the Treatment Phase"|"C-SSRS is a clinician rated assessment of suicidal behavior and / or intent categorized as: Suicidal behavior=a yes response to any of 5 suicidal behavior questions (preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide); Suicidal ideation=a yes response to any one of 5 suicidal ideation questions which includes wish to be dead, and 4 different categories of active suicidal ideation (thought, thought with method, thought with intent, thought with plan and intent)."|Week 1 to Week 12 (Treatment phase)|"Safety analysis set; N=number of participants assessed for suicidal behavior and / or ideation. Yes response includes participants with continued or new suicidal behavior and / or ideation. Treatment phase includes a 7 day lag after last dose of study treatment."||participants|||Number
761948|NCT00644969|Primary|Change From Baseline to Week 24 in Simpson Angus Rating Scale (SARS)|10-item rating scale to assess the severity of extrapyramidal symptoms rated on a 5-point scale 0 (normal) to 4 (highest severity). Items measured are gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, leg pendulousness, head dropping, glabella tap, tremor, and salivation. Global score calculated by summing individual item scores and dividing by the total number of items; range is 0 to 40 with higher scores indicating greater severity.|Baseline to Week 24|Safety analysis set; N=number of participants with analyzable data at observation.||scores on a scale||Standard Deviation|Mean
761949|NCT00644969|Primary|Change From Baseline to Week 12 in Simpson Angus Rating Scale (SARS)|10-item rating scale to assess the severity of extrapyramidal symptoms rated on a 5-point scale 0 (normal) to 4 (highest severity). Items measured are gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, leg pendulousness, head dropping, glabella tap, tremor, and salivation. Global score calculated by summing individual item scores and dividing by the total number of items; range is 0 to 40 with higher scores indicating greater severity.|Baseline to Week 12|Safety analysis set; (n)=number of participants with analyzable data at observation for varenicline and placebo, respectively.||scores on a scale||Standard Deviation|Mean
761950|NCT00644969|Primary|Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Negative Symptoms Score|PANSS includes 30 items rated on a 7-point scale (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme) organized as 7 positive symptom subscale items, 7 negative symptom subscale items and 16 general psychopathology items. Negative symptoms (deficit features) associated with schizophrenia (blunted affect, emotional withdrawal, poor rapport, and passive / apathetic social withdrawal) are rated on a scale from 1 (absent) to 7 (extreme); total negative subscale scores range from 7 to 49 with higher scores indicating more extreme symptoms.|Baseline to Week 24|Safety analysis set; N=number of participants with analyzable data at observation.||scores on a scale||Standard Deviation|Mean
762016|NCT00645853|Secondary|AZD0837: Plasma Concentration of AZD0837 at End of Treatment||End of treatment|Only patients who switched to one dose, 300 mg od, are included in the AZD0837 analysis||nmol/L||Full Range|Median
761951|NCT00644969|Primary|Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Negative Symptoms Score|PANSS includes 30 items rated on a 7-point scale (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme) organized as 7 positive symptom subscale items, 7 negative symptom subscale items and 16 general psychopathology items. Negative symptoms (deficit features) associated with schizophrenia (blunted affect, emotional withdrawal, poor rapport, and passive / apathetic social withdrawal) are rated on a scale from 1 (absent) to 7 (extreme); total negative subscale scores range from 7 to 49 with higher scores indicating more extreme symptoms.|Baseline to Week 12|Safety analysis set; (n)=number of participants with analyzable data at observation for varenicline and placebo, respectively.||scores on a scale||Standard Deviation|Mean
761952|NCT00644969|Primary|Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Positive Symptoms Score|PANSS includes 30 items rated on a 7-point scale (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme) organized as 7 positive symptom subscale items, 7 negative symptom subscale items and 16 general psychopathology items. Positive symptoms (productive symptoms) associated with schizophrenia (delusions, conceptual disorganization, and hallucinatory behavior) are rated on a scale from 1 (absent) to 7 (extreme); total positive subscale scores range from 7 to 49 with higher scores indicating more extreme symptoms.|Baseline to Week 24|Safety analysis set; N=number of participants with analyzable data at observation.||scores on a scale||Standard Deviation|Mean
761953|NCT00644969|Primary|Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Positive Symptoms Score|PANSS includes 30 items rated on a 7-point scale (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme) organized as 7 positive symptom subscale items, 7 negative symptom subscale items and 16 general psychopathology items. Positive symptoms (productive symptoms) associated with schizophrenia (delusions, conceptual disorganization, and hallucinatory behavior) are rated on a scale from 1 (absent) to 7 (extreme); total positive subscale scores range from 7 to 49 with higher scores indicating more extreme symptoms.|Baseline to Week 12|Safety analysis set; (n)=number of participants with analyzable data at observation for varenicline and placebo, respectively.||scores on a scale||Standard Deviation|Mean
761954|NCT00644969|Primary|Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Total Score|PANSS includes 30 items rated on a 7-point scale (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme) organized as 7 positive symptom subscale items, 7 negative symptom subscale items and 16 general psychopathology items. Total scores range from 30 to 210 with higher scores indicating more extreme symptoms.|Baseline to Week 24|Safety analysis set; N=number of participants with analyzable data at observation.||scores on a scale||Standard Deviation|Mean
761955|NCT00644969|Primary|Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Total Score|PANSS includes 30 items rated on a 7-point scale (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme) organized as 7 positive symptom subscale items, 7 negative symptom subscale items and 16 general psychopathology items. Total scores range from 30 to 210 with higher scores indicating more extreme symptoms.|Baseline to Week 12|Safety analysis set; (n)=number of participants with analyzable data at observation for varenicline and placebo, respectively.||scores on a scale||Standard Deviation|Mean
761956|NCT00644969|Primary|Number of Participants With Psychiatric Adverse Events|Psychiatric Adverse Event symptoms included, but were not restricted to, depression, anxiety, hostility, perceptual / thinking disturbance, suicidal ideation, or suicidal behavior based on clinical judgment and use of the Positive and Negative Syndrome Scale and Columbia Classification Algorithm of Suicide assessments.|Baseline up to Week 24|Safety analysis set; Safety assessed Baseline through Week 12 (treatment phase) plus a 30 day lag period after last dose of study treatment). Neuropsychiatric events assessed through Week 24.||participants|||Number
761957|NCT00644969|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|AEs are any untoward medical occurrence in a clinical investigation participant administered a product or medical device. The event does not need to be causally related to the study treatment or usage. SAEs include any untoward medical occurrence that results in death, are life threatening, requires hospitalization or prolongation of hospitalization, results in disability or incapacity or are a congenital anomaly or birth defect in the offspring of a study participant. Lack of efficacy was to be reported as an AE when it was associated with an SAE.|Baseline up to 30 days after last dose of study treatment or up to Week 16|Safety analysis set: all participants who took at least 1 dose of randomized study medication, including partial doses and had a safety measurement. Safety assessed Baseline through Week 12 (treatment phase) plus a 30 day lag period after last dose of study treatment).||participants|||Number
761965|NCT00645047|Secondary|PTSD Checklist (PCL)|"PTSD Checklist-Military Version (PCL). The PCL is a 17-item self-report measure of the 17 DSM-IV symptoms of PTSD. The PCL has a variety of purposes, including screening individuals for PTSD, diagnosing PTSD, and monitoring symptom change during and after treatment.
A total symptom severity score (range = 17-85) can be obtained by summing the scores from each of the 17 items that have response options ranging from 1 Not at all to 5 Extremely."|6 Month Visit|||units on a scale||Standard Deviation|Mean
762017|NCT00645853|Secondary|Electroconvulsive Therapy (ECT): Absolute Change From Baseline to End of Treatment||Baseline and End of Treatment|Only patients who switched to one dose, 300 mg od, are included in the AZD0837 analysis||sec||Full Range|Median
761966|NCT00645047|Secondary|PTSD Checklist (PCL)|"PTSD Checklist-Military Version (PCL). The PCL is a 17-item self-report measure of the 17 DSM-IV symptoms of PTSD. The PCL has a variety of purposes, including screening individuals for PTSD, diagnosing PTSD, and monitoring symptom change during and after treatment.
A total symptom severity score (range = 17-85) can be obtained by summing the scores from each of the 17 items that have response options ranging from 1 Not at all to 5 Extremely."|Post Visit|||units on a scale||Standard Deviation|Mean
761967|NCT00645047|Secondary|PTSD Checklist (PCL)|"PTSD Checklist-Military Version (PCL). The PCL is a 17-item self-report measure of the 17 DSM-IV symptoms of PTSD. The PCL has a variety of purposes, including screening individuals for PTSD, diagnosing PTSD, and monitoring symptom change during and after treatment.
A total symptom severity score (range = 17-85) can be obtained by summing the scores from each of the 17 items that have response options ranging from 1 Not at all to 5 Extremely."|Baseline|||units on a scale||Standard Deviation|Mean
761968|NCT00645047|Secondary|Patient Health Questionnaire-9 (PHQ-9)|"The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression.
Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. Validity has been assessed against an independent structured mental health professional (MHP) interview. PHQ-9 score ≥10 had a sensitivity of 88% and a specificity of 88% for major depression."|6 Month Visit|||units on a scale||Standard Deviation|Mean
761969|NCT00645047|Secondary|Patient Health Questionnaire-9 (PHQ-9)|"The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression.
Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. Validity has been assessed against an independent structured mental health professional (MHP) interview. PHQ-9 score ≥10 had a sensitivity of 88% and a specificity of 88% for major depression."|Post Visit|||units on a scale||Standard Deviation|Mean
761970|NCT00645047|Secondary|Patient Health Questionnaire-9 (PHQ-9)|"The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression.
Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. Validity has been assessed against an independent structured mental health professional (MHP) interview. PHQ-9 score ≥10 had a sensitivity of 88% and a specificity of 88% for major depression."|Baseline|||units on a scale||Standard Deviation|Mean
761971|NCT00645047|Primary|CAPS - PTSD Symptom Severity Score|"The CAPS-5 is a 30-item clinician administered interview designed to diagnose current and lifetime PTSD and to assess PTSD symptom-severity over the past week. The interview assesses 20 DSM-5 PTSD symptoms as well as onset, duration, distress, and functional impact, overall validity, PTSD severity, and presence of dissociation. Prior to assessing symptoms, the clinical interviewer works with the patient to establish an index-trauma and each follow-up question focuses on symptoms as they relate to the index trauma.
Severity Rating
0. Absent; 1. Mild / subthreshold; 2. Moderate / threshold; 3. Severe / markedly elevated; and 4. Extreme / incapacitating.
Higher scores means more severe symptoms. Total symptom severity score may range from 0-80, higher scores meaning more severe symptoms."|6 Month Visit|||units on a scale||Standard Deviation|Mean
761972|NCT00645047|Primary|CAPS - PTSD Symptom Severity Score|"The CAPS-5 is a 30-item clinician administered interview designed to diagnose current and lifetime PTSD and to assess PTSD symptom-severity over the past week. The interview assesses 20 DSM-5 PTSD symptoms as well as onset, duration, distress, and functional impact, overall validity, PTSD severity, and presence of dissociation. Prior to assessing symptoms, the clinical interviewer works with the patient to establish an index-trauma and each follow-up question focuses on symptoms as they relate to the index trauma.
Severity Rating
0. Absent; 1. Mild / subthreshold; 2. Moderate / threshold; 3. Severe / markedly elevated; and 4. Extreme / incapacitating.
Higher scores means more severe symptoms. Total symptom severity score may range from 0-80, higher scores meaning more severe symptoms."|Post Visit|||units on a scale||Standard Deviation|Mean
761973|NCT00645047|Primary|CAPS - PTSD Symptom Severity Score|"The CAPS-5 is a 30-item clinician administered interview designed to diagnose current and lifetime PTSD and to assess PTSD symptom-severity over the past week. The interview assesses 20 DSM-5 PTSD symptoms as well as onset, duration, distress, and functional impact, overall validity, PTSD severity, and presence of dissociation. Prior to assessing symptoms, the clinical interviewer works with the patient to establish an index-trauma and each follow-up question focuses on symptoms as they relate to the index trauma.
Severity Rating
0. Absent; 1. Mild / subthreshold; 2. Moderate / threshold; 3. Severe / markedly elevated; and 4. Extreme / incapacitating.
Higher scores means more severe symptoms. Total symptom severity score may range from 0-80, higher scores meaning more severe symptoms."|Baseline|||units on a scale||Standard Deviation|Mean
761974|NCT00645099|Secondary|Change From Baseline to End Point in Total Positive and Negative Syndrome Scale Score (PANSS)|PANSS is an investigator-rated 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. The PANSS provided a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each rated on a scale of 1 (absent) to 7 (extreme).|Baseline to End Point (up to 6 months)|The secondary endpoint analysis set included all patients who received study medication at least once and provided ≥1 post-baseline efficacy measurement. Therefore, the total number of patients in the analysis set depends on the number of patients having post-baseline data for the particular secondary efficacy parameter under discussion.||points on a scale||Standard Deviation|Mean
761975|NCT00645099|Secondary|Number of Patients First Meeting the NCEP/ATP III Criteria for Metabolic Syndrome During Follow-up|"Metabolic syndrome is defined according the Third Report of the National Cholesterol Education Program Expert Panel on
Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (NCEP/ATPIII) of which 3 out of 5 criteria must be met:
waist circumference men > 102 cm; waist circumference women > 88 cm
TG ≥ 150 mg/dL
HDL cholesterol men <40 mg/dL; HDL cholesterol women <50 mg/dL
Blood pressure systolic ≥ 130 mmHg; Blood pressure diastolic ≥ 85 mmHg
Fasting glucose ≥ 110 mg /dL"|6 months|The secondary endpoint analysis set included all patients who received study medication at least once and provided ≥1 post-baseline efficacy measurement. In this case, the total number of patients in the analysis set depends on the number of patients without metabolic syndrome at baseline.||Participants|||Number
762018|NCT00645853|Secondary|Activated Partial Thromboplastin Time (APTT): Absolute Change From Baseline to End of Treatment|Median Full range, Seconds|Baseline and End of treatment|Only patients who switched to one common dose, 300 mg od, are included in the AZD0837 analysis||sec||Full Range|Median
761976|NCT00645099|Secondary|Change From Baseline at End Point in Waist Circumference|Patients had to be instructed to stand erect with abdomen relaxed, arms at sides, feet together, and weight divided equally over both legs. The tape measure was placed around the bare abdomen midway between the palpated iliac crest and the palpated lowest rib margin in the left and right mid-axillary lines. A nonstretchable tape was evenly placed around the natural waist covering the left and right natural-waist marks. The measurement scale had to face outward, and there could not be any twists in the tape. The tape had to be just touching the skin but not compressing the soft tissue.|Baseline to End Point (up to 6 months)|Safety data were analyzed using the ITT analysis set for safety and consisted of 459 patients, i.e., all patients who received study medication at least once and provided any post-baseline safety data. Changes from baseline could only be calculated for patients with paired data.||cm||Standard Deviation|Mean
761977|NCT00645099|Secondary|Change From Baseline at End Point in Body Mass Index (BMI)|BMI is calculated by dividing the body weight (in kg) by the square of height (in meters).|Baseline to End Point (up to 6 months)|||kg/m²||Standard Deviation|Mean
761978|NCT00645099|Secondary|Change From Baseline at End Point in Body Weight|Patients were weighed lightly clothed. The same amount of clothing had to be worn each time.|Baseline to End Point (up to 6 months)|Safety data were analyzed using the ITT analysis set for safety and consisted of 459 patients, i.e., all patients who received study medication at least once and provided any post-baseline safety data. Changes from baseline could only be calculated for patients with paired data.||kg||Standard Deviation|Mean
761979|NCT00645099|Secondary|Change From Baseline at End Point of Mari-Type Analysis of Glucose Sensitivity for Insulin|As another measure of beta-cell function, the relationship between plasma insulin and glucose concentrations during the OGTT was calculated using a simplified version of the method described by Mari et al. (Mari A, Sallas WM, He YL, Watson C, Ligueros-Saylan M, Dunning BE, Deacon CF, Holst JJ, Foley JE. Vildagliptin, a dipeptidyl peptidase-IV inhibitor, improves model-assessed beta-cell function in patients with type 2 diabetes. J Clin Endocrinol Metab. 2005; 90:4888-4894.).|Baseline to End Point (up to 6 months)|The secondary end point analysis set included all patients who received study medication at least once and provided ≥1 post-baseline efficacy measurement. Therefore, the total number of patients in the analysis set depends on the number of patients having post-baseline data for the particular secondary efficacy parameter under discussion.||pM/mM||Standard Deviation|Mean
761980|NCT00645099|Secondary|Change From Baseline at End Point of the Insulinogenic Index|The insulinogenic index, defined as (insulin at 30 min - insulin at 0)/(glucose at 30 min [G(30)] - glucose at 0 [G(0)]) was used as a measure of early insulin secretion in response to the OGTT. Because the index is undefined when G(30)-G(0)=0, and poorly defined when G(30)-G(0)<0, the index was only calculated when G(30)>G(0).|Baseline to End Point (up to 6 months)|The secondary end point analysis set included all patients who received study medication at least once and provided ≥1 post-baseline efficacy measurement. Therefore, the total number of patients in the analysis set depends on the number of patients having post-baseline data for the particular secondary efficacy parameter under discussion.||pM/mM||Standard Deviation|Mean
761981|NCT00645099|Secondary|Number of Patients With Impaired Fasting Glucose|Post-baseline glucose level under fasted conditions ≥100 mg/dL but <126 mg/dL.|Baseline to End Point (up to 6 months)|The secondary end point analysis set included all patients who received study medication at least once and provided ≥1 post-baseline efficacy measurement. Therefore, the total number of patients in the analysis set depends on the number of patients having post-baseline data for the particular secondary efficacy parameter under discussion.||Participants|||Number
761982|NCT00645099|Secondary|Number of Patients With Onset of Impaired Glucose Tolerance|Glucose ≥140 mg/dL, <200 mg/dL after a 75g OGTT.|Baseline to End Point (up to 6 months)|The secondary end point analysis set included all patients who received study medication at least once and provided ≥1 post-baseline efficacy measurement.Therefore, the total number of patients in the analysis set depends on the number of patients having post-baseline data for the particular secondary efficacy parameter under discussion.||Participants|||Number
761983|NCT00645099|Secondary|Number of Patients Meeting the Criteria for Type 2 Diabetes Mellitus During Follow-up|Fasting plasma glucose ≥126 mg/dL or 2-hour post-load plasma glucose ≥200 mg/dL during an oral glucose tolerance test (OGTT) or initiated use of glucose-lowering agents during the course of the study.|6 months|The secondary end point analysis set included all patients who received study medication at least once and provided ≥1 post-baseline efficacy measurement.Therefore, the total number of patients in the analysis set depends on the number of patients having post-baseline data for the particular secondary efficacy parameter under discussion.||Participants|||Number
761984|NCT00645099|Secondary|Change From Baseline to End Point in Homeastatic Model Assessment of Insulin Resistance (HOMA-IR)|HOMA-IR is used to assess insulin resistance (IR). HOMA-IR is a dimensionless measure of insulin resistance (higher values present more insulin resistance. HOMA-IR are normalized so that lean, healthy individuals will have values of HOMA-IR close to 1.|Baseline to End Point (up to 6 months)|The secondary end point analysis set included all patients who received study medication at least once and provided ≥1 post-baseline efficacy measurement. Therefore, the total number of patients in the analysis set depends on the number of patients having post-baseline data for the particular secondary efficacy parameter under discussion.||dimensionless||Standard Deviation|Mean
761985|NCT00645099|Secondary|Change From Baseline to End Point in Homeostatic Model Assessment of Beta-cell Function (HOMA-%B)|"HOMA-%B is used to assess beta-cell function. HOMA-%B is a dimensionless measure of beta-cell function (higher values present increased insulin secretion for a given glucose level).
HOMA-%B is normalized so that lean, healthy individuals will have values of HOMA-%B close to 100%."|Baseline to End Point (up to 6 months)|The secondary end point analysis set included all patients who received study medication at least once and provided ≥1 post-baseline efficacy measurement. Therefore, the total number of patients in the analysis set depends on the number of patients having post baseline data for the particular secondary efficacy parameter under discussion.||dimensionless||Standard Deviation|Mean
761986|NCT00645099|Secondary|Change From Baseline to End Point in Fasting Glucose||Baseline to End Point (up to 6 months)|Safety data were analyzed using the ITT analysis set for safety and consisted of 459 patients, i.e., all patients who received study medication at least once and provided any post-baseline safety data. Changes from baseline could only be calculated for patients with paired data.||mmol/L||Standard Deviation|Mean
761988|NCT00645099|Secondary|Change From Baseline to End Point in Low Density Lipoprotein Cholesterol (Friedwald QT)|The level of low density lipoprotein cholesterol was calculated using the Friedwald QT formula.|Baseline to End Point (up to 6 months)|Safety data were analyzed using the ITT analysis set for safety and consisted of 459 patients, i.e., all patients who received study medication at least once and provided any post-baseline safety data. Changes from baseline could only be calculated for patients with paired data.||mmol/L||Standard Deviation|Mean
761989|NCT00645099|Secondary|Change From Baseline to End Point in Total Cholesterol|The total cholesterol level was assessed under fasted conditions.|Baseline to End Point (up to 6 months)|Safety data were analyzed using the Intent-to-Treat (ITT) analysis set for safety and consisted of 459 patients, i.e., all patients who received study medication at least once and provided any post-baseline safety data. Changes from baseline could only be calculated for patients with paired data.||mmol/L||Standard Deviation|Mean
761990|NCT00645099|Secondary|Change From Baseline to End Point in High Density Lipoprotein|The HDL level was assessed under fasted conditions.|Baseline to End Point (up to 6 months)|The secondary end point analysis set included all patients who received study medication at least once and provided ≥1 post-baseline efficacy measurement. Therefore, the total number of patients in the analysis set depends on the number of patients having post-baseline data for the particular secondary efficacy parameter under discussion.||mmol/L||Standard Deviation|Mean
761991|NCT00645099|Secondary|Change From Baseline to End Point in Triglycerides|The TG level was assessed under fasted conditions.|Baseline to End Point (up to 6 months)|The secondary end point analysis set included all patients who received study medication at least once and provided ≥1 post-baseline efficacy measurement. Therefore, the total number of patients in the analysis set depends on the number of patients having post-baseline data for the particular secondary efficacy parameter under discussion.||mmol/L||Standard Deviation|Mean
761992|NCT00645099|Primary|Change From Baseline to End Point in the Triglycerides (TG) to High Density Lipoprotein (HDL) Ratio (TG:HDL Ratio)|Plasma fasting TG and HDL concentrations were measured to determine the TG:HDL ratio.|Baseline to End Point (up to 6 months)|The primary end point analysis set consisted of 413 patients, i.e., all patients who received study medication at least once and had baseline and post-baseline TG and HDL data. Data of patients with missing TG or HDL values or who started or changed lipid-lowering medication during the trial were excluded from analysis.||Ratio||Standard Deviation|Mean
761993|NCT00645164|Primary|Frequency Distribution of Skin Irritation Scores|Scores based on skin irritation scale of 0 (no reaction) to 7 (large vesiculo-bullous reaction) in whole units. Photoallergic reactions were characterized by irritation scores of 3 or higher.|48-hours post irradiation|Analysis was based on number of subjects who completed the study.||Scores on a scale|||Number
761994|NCT00645671|Primary|Grade 0 for Pain|Pain: A positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching. Grade 0 = None; 1=Minimal; 2=Mild; 3=Moderate; 4=Moderately Severe; 5=Severe|Postoperative Day 8 (Visit 5)|Intent to treat population||participants|||Number
761995|NCT00645671|Secondary|Change From Baseline to Each Follow-up Visit in Anterior Chamber Cells and Flare|A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= >30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe.|Baseline and each follow-up visit through day18 (Visit 7)|Intent to treat population||Composit scores||Standard Deviation|Mean
761996|NCT00645671|Secondary|Subjects With Complete Resolution of Anterior Chamber Cells and Flare. At Each Follow-up Visit.|A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= >30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe.|At each follow-up visit through day18 (Visit 7)|Intent to treat population||participants|||Number
761997|NCT00645671|Primary|Subjects With Complete Resolution of Anterior Chamber Cells and Flare. Grade=0.|A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= >30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe.|Postoperative Day 8 (Visit 5)|Intent to treat population||participants|||Number
761998|NCT00645762|Primary|Symptomatic Score Change- Sinonasal Outcome (SNOT) 20 Score Improvement|"Symptomatic change in SNOT 20 scores on a 5-point Likert scale where 0 = no problem to 5 = problem as bad as it can be were calculated. Baseline scores and 12 month post-procedure follow-up scores were calculated and compared. A score reduction of at least 0.8 (-0.8) from baseline to 12 months is considered statistically significant and clinically impactful."|Post-treatment through 12 months|Score reduction in SNOT 20 Scale Scores. Baseline through 12 months post-procedure.||Scores on a scale|||Number
761999|NCT00645762|Primary|Patency of the Treated Area as Verified by CT Scan|Post-procedure Patency was assessed using a CT scan 3 months post-procedure. The osteomeatal complex was assessed for patency by physicians.|Post-treatment at 3 months|Analysis of ostia patency done per protocol||Ostia|Participants||Number
762000|NCT00645762|Primary|Incidences of Device-related or Procedure-related Complications||Through 12 months post-procedure|Patients completing 12 month follow-up||participants|||Number
762001|NCT00645788|Secondary|Number of Participants With the Occurrence of Drug Induced Bronchospasms|"Bronchospasm reported as adverse event: Bronchospasm defined as >=15% drop in FEV1, and may also include allergic and excercise-induced bronchospasm. Drug-induced bronchospasm: Treatment-emergent bronchospasm was defined as >=15% drop in FEV1 in the ITT/safety population. Note: One of the bronchospasm events was considered a serious adverse event, and it was not included under other adverse events. A sum of bronchospasm events was 1+6=7."|Up to visit 9 (Day 56-60)|Intent to treat||participants|||Number
762002|NCT00645788|Secondary|Sputum Concentrations of Ciprofloxacin From Selected Participants During Treatment|Sputum concentrations measured using validated HPLC-MS/MS methods in selected patients to contribute kinetic information for an inter-study population sputum kinetic evaluation. Number of samples vary at different time points.|Up to visit 7 (Day 28-30)|Analysis was not performed due to insufficient data.|||||
762003|NCT00645788|Secondary|Plasma Concentrations of Ciprofloxacin From Selected Participants During Treatment|Plasma concentrations measured using validated high pressure liquid chromatography-mass specroscopy/mass spectroscopy (HPLC-MS/MS) methods in selected patients at predefined time windows to contribute pharmacokinetic (PK) information for an inter-study population PK evaluation. Sampling window for Plasma: Predose (trough level), <15 min, 2.0 - 2.5 hour, and 4.0 - 7.0 hours after the end of inhalation. Number of samples vary at different time points.|Up to visit 7 (Day 28-30)|Analysis was not performed due to insufficient data.|||||
762004|NCT00645788|Secondary|Effect of Ciprofloxacin DPI Treatment on Quality of Life Measured by Cystic Fibrosis Quality of Life Questionnaire Revised (CFQ-R), Respiratory Scale|The CF quality of life questionnaire revised (CFQ-R), a validated disease-specific instrument that measures health-related quality of life (HRQOL) for adolescents and adults with cystic fibrosis (CF). It is self-administered and consists of 44 items, divided into 12 generic and disease-specific scales. The scale includes physical functioning, role, vitality, emotional functioning, social functioning, body image, eating disturbances, treatment burden, health perceptions, weight, respiratory symptoms, and digestive symptoms. Scale range: 0 to 100 (maximum). Better outcome with higher values.|Baseline and Visit 7 (Day 28-30) and Visit 9 (Day 56 -60)|Intent to treat||scores on a scale||Standard Deviation|Mean
762005|NCT00645788|Secondary|Number of Participants Developing Ciprofloxacin-resistant Non-mucoid P.Aeruginosa Isolates|Susceptibility and resistance assessment of a bacterial isolate was performed using the established Food and Drug Administration (FDA) susceptibility criteria for ciprofloxacin. The susceptibility criteria in mg/L are ≤1 for organisms Enterobacteriaciae, P. aeruginosa, Staphylococcus species and S. pneumoniae. The “susceptible” bacterial species likely responds to typical doses of ciprofloxacin. The resistance criteria for ciprofloxacin in mg/L are ≥4 mg/L for the same organisms. Resistance indicates that the bacteria is less likely to respond to typical doses of ciprofloxacin therapy.|Baseline and up to visit 9 (day 56-60)|Intent to treat||Participants|||Number
762006|NCT00645788|Secondary|Number of Participants Developing Ciprofloxacin-resistant Mucoid P.Aeruginosa Isolates|Susceptibility and resistance assessment of a bacterial isolate was performed using the established Food and Drug Administration (FDA) susceptibility criteria for ciprofloxacin. The susceptibility criteria in mg/L are ≤1 for organisms Enterobacteriaciae, P. aeruginosa, Staphylococcus species and S. pneumoniae. The “susceptible” bacterial species likely responds to typical doses of ciprofloxacin. The resistance criteria for ciprofloxacin in mg/L are ≥4 mg/L for the same organisms. Resistance indicates that the bacteria is less likely to respond to typical doses of ciprofloxacin therapy.|Baseline and up to visit 9 (day 56-60)|Intent to treat||Participants|||Number
762007|NCT00645788|Secondary|Change From Baseline in Forced Expiratory Flow (FEF 25-75%) at Visits 4, 5, 7, 8 and 9|FEF 25-75% (also known as the maximum midexpiratory flow [MMEF]): The mean forced expiration flow over the middle half of the forced vital capacity (FVC). It was taken from the blow with the largest sum of FEV1 and FVC. The later time point minus baseline, days as planned and the last observation carried forward (LOCF) used.|Baseline and Visit 4 (Day 7-9), Visit 5 (Day 14-16), Visit 7 (Day 28-30), Visit 8 (Day 41-45), and Visit 9 (Day 56 -60).|Intent to treat||Percent of predicted FEF 25-75%||Standard Deviation|Mean
762008|NCT00645788|Secondary|Change From Baseline in Forced Vital Capacity (FVC) at Visits 4, 5, 7, 8 and 9|FVC: The maximal volume of air exhaled with maximally forced effort from a maximal inspiration, ie, vital capacity performed with a maximally forced expiratory effort expressed in liters at BTPS (body temperature and ambient pressure saturated with water vapor). The later time point minus baseline, days as planned and the last observation carried forward (LOCF) used.|Baseline and Visit 4 (Day 7-9), Visit 5 (Day 14-16), Visit 7 (Day 28-30), Visit 8 (Day 41-45), and Visit 9 (Day 56 -60).|Intent to treat||Percent of predicted FVC||Standard Deviation|Mean
762009|NCT00645788|Secondary|Time to First Pulmonary Exacerbation Requiring Intervention|Pulmonary exacerbations: Assessment of pulmonary exacerbation was conducted by the treating physician as part of the physical examination. Pulmonary exacerbation was defined by chest examination findings and any or all of the following symptoms: decreased exercise tolerance, increased cough, increased sputum/cough congestion, school or work absenteeism, increased adventitial sounds on the lung examination, and decreased appetite.|Up to visit 9 (Day 56-60)|Intent to treat||Days||Inter-Quartile Range|Median
762010|NCT00645788|Secondary|Change From Baseline in P. Aeruginosa Density in the Sputum at Visits 4, 5, 7, 8 and 9|Density of P. aeruginosa in the sputum is expressed as log10 of colony forming units (CFU)/gram (g). The later time point minus baseline, days as planned and the last observation carried forward (LOCF) used.|Baseline and Visit 4 (Day 7-9), Visit 5 (Day 14-16), Visit 7 (Day 28-30), Visit 8 (Day 41-45), and Visit 9 (Day 56 -60).|Intent to treat||log10(cfu/g)||Standard Deviation|Mean
762011|NCT00645788|Secondary|Change From Baseline in FEV1 at Visits 4, 5, and Follow-up Visits 8 and 9|FEV1: The maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration, expressed in liters at body temperature and ambient pressure saturated with water vapor (BTPS). This was recorded at the site using a spirometer. The later time point minus baseline, days as planned and the last observation carried forward (LOCF) used.|Baseline and Visit 4 (Day 7-9), Visit 5 (Day 14-16), Visit 8 (Day 41-45), and Visit 9 (Day 56 -60).|Intent to treat||Percent of predicted FEV1||Standard Deviation|Mean
762012|NCT00645788|Primary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Day 28‑30|FEV1: The maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration, expressed in liters at body temperature and ambient pressure saturated with water vapor (BTPS). This was recorded at the site using a spirometer. The later time point minus baseline, days as planned and the last observation carried forward (LOCF) used.|Baseline and End of treatment (Day 28-30)|Intent to treat||Percent of predicted FEV1||Standard Deviation|Mean
762013|NCT00645827|Secondary|Hypoglycemia (Serum Blood Glucose < 70 mg/dL)||Within 24 hours after cessation of IV insulin||||||
762014|NCT00645827|Primary|Percentage of Blood Glucose Values Within 80-140 mg/dL|Fingerstick glucose measurements were obtained up to six times for each participant. Percentage of blood glucose values within the target range of 80-140 mg/dL|Within 24 hours after cessation of IV insulin|||percentage of blood glucose values|||Number
762015|NCT00645853|Secondary|AR-H067637XX, the Active Major Metabolite of AD0837: Plasma Concentration of AR-H067637XX, at End of Treatment||154-711 days on treatment|Only patients who switched to one dose, 300 mg od, are included in the AZD0837 analysis||nmol/L||Full Range|Median
762025|NCT00645970|Primary|Numeric Rating Scales of Pain Over Past Week (11 Point Likert Scale)|Numeric Pain Rating Scale is a self-report measure of “usual” (average) pain intensity over the last week; response options range from “no pain” (0) to “worst pain imaginable” (10). A score >3 indicates moderate-to-severe pain.|Baseline, 6 months, 1 year|Numeric Pain Rating Scale data are missing for 21 participants (PSC n=1; Registry n=20)||units on a scale||Standard Deviation|Mean
762026|NCT00646048|Secondary|Number of Participants Who Achieve Technical Success of the Stent Graft System.|Technical success was defined as successful introduction of the delivery catheter into the arterial system at the time of the study procedure and successful delivery/deployment of the stent graft system to the intended location with the absence of device related surgical conversion and intra-operative mortality. Device related surgical conversion is defined as the inability to deliver or deploy the stent graft system, then subsequently surgically treating the patient.|Post procedure|||Participants|||Number
762027|NCT00646048|Primary|Number of Participants Without a Type I, III, and/or IV Endoleak at 1 Month Follow-up Identified by Computed Tomography (CT).|A Type I endoleak is a persistent perigraft channel of blood flow that develops due to inadequate or ineffective seal at the graft ends (attachment zones). A Type III endoleak occurs in the midgraft region due to leakage through a defect in the graft fabric or between the segments of a multisegmental graft. A Type IV endoleak is seen on completion of angiography or subsequent contrast studies as any blush of contrast that is presumed to emanate from blood diffusion across the porous graft fabric or through small holes in the graft cause by sutures or stent struts.|1 month|||Participants|||Number
762028|NCT00646048|Primary|Number of Participants Without a Device Related Adverse Events Within 1 Month of the Study Procedure.|Device related adverse events included, but were not limited to: Stent Graft Migration, Vessel dissection or perforation, stent graft occlusion, branch vessel occlusion, aneurysm rupture.|1 month|||Participants|||Number
762029|NCT00646282|Primary|Number of Subjects With 50% Reduction of Intact Parathyroid Hormone (iPTH) Levels|Number of participants that have 50% reduction in iPTH levels (but not lower than 65 pg/ml) at 18 months|18 months|Data not analyzed due to study termination|||||
762030|NCT00646399|Primary|The Number of Participants With Staphylococcal Sepsis From Study Days 0 to 35.|Safety and efficacy|35 days|1579 very low birth weight subjects were included in the ITT.||Participants|||Number
762031|NCT00646581|Primary|Improvement in Cognitive Function- CPT False Alarm Rate (Proportion)|"Subjects performed a computer-based test designed to measure sustained attention before and after intranasal treatment. The task is described in detail in a previous outcome measure (CPT d score). False alarm rate refers to the proportion of overall attempts that were characterized as incorrect responses (responses to two non-identical targets). Values below represent posttreatment performance minus pretreatment performance."|pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration|30 subjects were analyzed. Subjects were randomized to either the experimental or placebo group.||Proportion of overall attempts||Standard Deviation|Mean
762032|NCT00646581|Primary|Improvement in Cognitive Function- CPT Reaction Time of Hits (Milliseconds)|"Subjects performed a computer-based test designed to measure sustained attention before and after intranasal treatment. The task is described in detail in a previous outcome measure (CPT d score). Reaction time of hits refers to the average time each participant took to correctly respond to a stimuli in milliseconds. Values below represent posttreatment performance minus pretreatment performance."|pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration|30 subjects were analyzed. Subjects were randomized to either the experimental or placebo group.||Milliseconds||Standard Deviation|Mean
762033|NCT00646581|Primary|Improvement in Cognitive Function- CPT Hits Rate (Proportion)|"Subjects performed a computer-based test designed to measure sustained attention before and after intranasal treatment. The task is described in the previous outcome measure (CPT d score). Hits rate refers to each participant's ability to correctly respond to two consecutive target presentations (i.e. correct responses). Hits rate was measured as a proportion of overall attempts (0= no hits, 1.0= 100% accuracy on hits). Values below represent posttreatment performance minus pretreatment performance."|pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration|30 subjects were analyzed. Subjects were randomized either to the experimental or placebo group.||Proportion of overall attempts||Standard Deviation|Mean
762034|NCT00646581|Primary|CPT d Score|"Subjects performed a computer-based test designed to measure sustained attention (attention to a specific stimuli over a period of several minutes) before and after intranasal treatment. During this test, participants respond as quickly as possible to any consecutive presentation of identical stimuli on the computer screen. The stimuli (2, 3, and 4-digit targets) were presented with increasing cognitive load in successive blocks. Correct responses, responses made to the second of 2 identical stimuli presented in a row, were scored as hits. False alarms were also recorded. The d prime score is a score given to each participant on a scale of 0.0- 1.0 in which discrimination sensitivity is measured. A score of zero equates to no sensitivity, whereas a score of 1.0 equates to perfect sensitivity. Values below represent postreatment performance minus pretreatment performance."|pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration|30 subjects were analyzed. Subjects were randomized to either the experimental or placebo group.||units on a scale||Standard Deviation|Mean
762541|NCT00653224|Secondary|Ocular Pruritus Score Over the Total Treatment Period (14 Days)|The ocular pruritus score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided.|Over total treatment period (14 days)|Number of participants from the ITT population with available ocular pruritus score over the Total Treatment period||points on a scale||Standard Deviation|Mean
762035|NCT00646581|Primary|Improvement in Cognitive Function- HVLT-Delayed Recall (Number)|Subjects performed the HVLT word recall task after a 20-minute delay before and after intranasal treatment. In the HVLT delayed recall task, participants were asked to recall the same list of 12 words dictated in the immediate recall task 20 minutes after the completion of the immediate recall task. Words successfully recalled after the 20-minute delay were measured. Values below represent posttreatment performance minus pretreatment performance.|pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration|30 subjects were analyzed in this study. Subjects were randomized to either the experimental or placebo group.||Words successfully recalled||Standard Deviation|Mean
762036|NCT00646581|Primary|Improvement in Cognitive Function- HVLT Immediate Recall Total (Number)|Subjects performed the HVLT Immediate Recall Task. For this task, participants were read aloud a list of 12 words from three taxonomic categories. Participants were read the list three separate times, and after each reading were immediately asked to recall as many words from the list as they could. The number of words recalled successfully was measured before and after intranasal treatment. Values below represent posttreatment performance minus pretreatment performance.|pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration|30 subjects were analyzed. Subjects were randomized to either the experimental or placebo group.||Words successfully recalled||Standard Deviation|Mean
762038|NCT00646763|Primary|Number of Participants for Whom Target Number of CD34+ Cells Were Collected.|Target numbers of CD34+ cells for a single autologous transplant are typically at least 5.0 * 10^6 cells/kg, a cell dose that consistently results in rapid cell engraftment|7 days|||participants|||Number
762039|NCT00646763|Secondary|Total Number of Days of Apheresis|the number of days of apheresis required to collect target numbers of CD34+ cells.|7 days|||days||Standard Deviation|Mean
762040|NCT00646763|Primary|The Total Number of CD34+ Cells Collected.||4 days|Patients at our institution between the ages of 18 and 70 years old with relapsed or refractory Hodgkin’s disease, non-Hodgkin’s lymphoma, or mutiple myelomawhowere scheduled for an autologous HSCTwere eligible to participate in the study.||cells per Kg||Standard Deviation|Mean
762041|NCT00646776|Secondary|Number of Participants With Clinically Significant Vital Signs or Physical Examination Findings|Vital signs assessments and physical examination were conducted throughout the study. Vital signs assessments included body temperature, respiratory rate, blood pressure (systolic and diastolic), and heart rate. Physical examination included a neurological examination (if ocular signs or symptoms occurred, a reflex to slit lamp exam was performed by an ophthalmologist). The investigator used his/her clinical judgment to decide whether or not abnormalities in vital signs or physical examination were clinically meaningful.|Vital signs:screening, prior to dosing on Day 1, Day 7, study discharge. Physical examination:screening, Day -1, Day 7, study discharge|All treated participants.||Participants|||Number
762042|NCT00646776|Secondary|Number of Participants With Identified Electrocardiogram (ECG) Abnormalities|ECG abnormalities were defined as findings that are clinically meaningful as judged by the investigator. A 12-lead ECG was recorded at least 5 minutes after the participant had been lying down and all ECG recordings were evaluated by the investigator. Abnormalities, if present at any study time point, were listed.|Pre-dose on Day -1 and study discharge.|All participants who received the study drug on Day 1 were included in the analysis.||Participants|||Number
762043|NCT00646776|Secondary|Number of Participants With MAs in Urinalysis|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following definitions specify the criteria for MAs. Protein, glucose and blood: >=2+ (or, if pre-treatment value >=1+, then >= 2 x pre-treatment value).|Pre-dose on Day -1, Day 7 and discharge.|"All participants who received the study drug on Day 1 were included in the analysis. If a value had not evaluable in the dataset, then these participants were not counted (for all parameters: protein, glucose and blood)."||Participants|||Number
762044|NCT00646776|Secondary|Number of Participants With MAs in Serum Chemistry: Glucose (Fasting Serum), Albumin, Creatine Kinase, Uric Acid, Lactate Dehydrogenase (LDH)|MAs=laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria. Glucose (fasting serum): <0.8 x LLN or >1.5 ULN (if pre-Rx <LLN, then <0.8 x pre-Rx or >ULN. If pre-Rx >ULN, then >2.0 x pre-Rx or <LLN. Albumin: <0.9 x LLN (if pre-Rx <LLN, then <0.9 x pre-Rx). Creatine kinase: >1.5 x ULN (if pre-Rx >ULN, then >1.5 x pre-Rx). Uric acid: >1.2 x ULN (if pre-Rx >ULN, then >1.25 x pre-Rx). LDH: >1.25 x ULN (if pre-Rx >ULN, then >1.5 x pre-Rx).|Pre-dose on Day -1 and post-dose on Days 3, 7, 11, 14, 20 and 26 for RIB 150 mg QD; and pre-dose on Day -1 and post-dose on Days 3, 7, 11, 14 and 18 for ATV/RTV 300/100 mg QD + RIB 150 mg twice weekly.|"All treated participants. If a value had not evaluable in the dataset, then these participants were not counted(albumin, creatine kinase, uric acid and LDH)."||Participants|||Number
762045|NCT00646776|Secondary|Number of Participants With MAs in Serum Chemistry: Chloride (Serum), Calcium (Total), Protein (Total), Bicarbonate, Phosphorous (Inorganic)|MAs=laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria. Chloride (serum), calcium (total), protein (total):<0.9xLLN or >1.1xULN (if pre-Rx <LLN, then <0.9xpre-Rx or >ULN. If pre-Rx >ULN, then >1.1xpre-Rx or <LLN). Bicarbonate:<0.8xLLN or >1.2xULN (if pre-Rx value <LLN, then <0.8xpre-Rx value or >ULN. If pre-Rx >ULN, then >1.2xpre-Rx value or <ULN). Phosphorous (inorganic):<0.85xLLN or >1.25xULN (if pre-Rx <ULN, then <0.85xpre-Rx or <ULN. If pre-Rx >ULN, then >1.25x re-Rx or <LLN).|Pre-dose on Day -1 and post-dose on Days 3, 7, 11, 14, 20 and 26 for RIB 150 mg QD; and pre-dose on Day -1 and post-dose on Days 3, 7, 11, 14 and 18 for ATV/RTV 300/100 mg QD + RIB 150 mg twice weekly.|All treated participants.||Participants|||Number
762055|NCT00646776|Secondary|Tmax of RTV|Tmax was derived from the plasma concentration versus time for RTV and was recorded directly from experimental observations for each treatment period.|Pre-dose (0h) on Days 4, 8, 11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.|All treated participants who received all doses of RTV as specified per protocol, and were evaluable for analysis.||Hour||Full Range|Median
762542|NCT00653224|Secondary|Ocular Pruritus Score Over the Second Week|The ocular pruritus score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided.|Over week 2|Number of participants from the ITT population with available ocular pruritus score over Week 2||points on a scale||Standard Deviation|Mean
762046|NCT00646776|Secondary|Number of Participants With MAs in Serum Chemistry: Alkaline Phosphatase (ALP),Aspartate Aminotransferase (AST),Alanine Aminotransferase (ALT),Bilirubin (Total),Bilirubin (Direct),Blood Urea Nitrogen (BUN),Creatinine,Sodium (Serum),Potassium (Serum)|MAs=laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria. ALP, AST, ALT:>1.25xULN (if pre-Rx >ULN, then >1.25xpre-Rx). Bilirubin (total), bilirubin (direct), BUN:>1.1xULN (if pre-Rx >ULN, then >1.25xpre-Rx). Creatinine:>1.33xpre-Rx. Sodium (serum):<0.95xLLN or >1.05xULN (if pre-Rx <LLN, then <0.95xpre-Rx or >ULN. If pre-Rx >ULN, then >1.05xpre-Rx or <LLN). Potassium (serum):<0.9xLLN or >1.1xULN (if pre-Rx <LLN, then <0.9xpre-Rx or >ULN. If pre-Rx >ULN, then >1.1xpre-Rx or <LLN).|Pre-dose on Day -1 and post-dose on Days 3, 7, 11, 14, 20 and 26 for RIB 150 mg QD; and pre-dose on Day -1 and post-dose on Days 3, 7, 11, 14 and 18 for ATV/RTV 300/100 mg QD + RIB 150 mg twice weekly.|"All treated participants. If a value had not evaluable in the dataset, then these participants were not counted (ALP, AST, ALT, bilirubin [total], bilirubin [direct], BUN and creatinine)."||Participants|||Number
762047|NCT00646776|Primary|Total Area Under the Plasma Concentration-time Curve (AUCtot)|AUCtot represents the total free RIB plus 25-O-Desacetyl-RIB output. It is calculated as: AUCtot (micromolar[µM]*h) = AUC24avg(RIB)(ng*h/mL)/847.016 (g/mole) + AUC24avg(25-O-Desacetyl-RIB)(ng*h/mL)/804.979(g/mole). The 300 mg RIB arm represents an extrapolation from the 150 mg RIB group.|Pre-dose (0h) on Days 6, 8, 10, and 11, and post-dose (1h,2h,3h,4h,6h,8h,12h) on Day 10 for RIB 150 mg QD; and pre-dose (0h) on Days 4, 8,11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.|"All treated participants who received all doses of RIB as specified per protocol, and were evaluable for analysis. The RIB 300 mg arm represents an extrapolation of the RIB 150 mg arm and as such, does not have a value for Number of Participants Analyzed. AUCtot for RIB 300 mg QD was calculated as 2 × AUCtot for RIB 150 mg QD."||µM*h||Full Range|Geometric Mean
762048|NCT00646776|Primary|Cmin of 25-O-Desacetyl-RIB|Cmin was derived from plasma concentration versus time for 25-O-Desacetyl-RIB.|Pre-dose (0h) on Days 6, 8, 10, and 11, and post-dose (1h,2h,3h,4h,6h,8h,12h) on Day 10 for RIB 150 mg QD; and pre-dose (0h) on Days 4, 8,11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.|All treated participants who received all doses of RIB as specified per protocol, and were evaluable for analysis.||ng/mL||Full Range|Geometric Mean
762049|NCT00646776|Primary|Cmax of 25-O-Desacetylrifabutin (25-O-Desacetyl-RIB)|Cmax was derived from the plasma concentration versus time for 25-O-Desacetyl-RIB (a metabolite of RIB) and was recorded directly from experimental observations for each treatment period.|Pre-dose (0h) on Days 6, 8, 10, and 11, and post-dose (1h,2h,3h,4h,6h,8h,12h) on Day 10 for RIB 150 mg QD; and pre-dose (0h) on Days 4, 8,11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.|All treated participants who received all doses of RIB as specified per protocol, and were evaluable for analysis.||ng/mL||Full Range|Geometric Mean
762050|NCT00646776|Primary|AUC24avg for 25-O-Desacetyl-RIB|AUC24avg is AUC(0-24 hour) following dosing on Day 10 for RIB 150 mg QD; AUC24avg is the area under the plasma concentration-time curve in 1 dosing interval (AUC[TAU]) divided by the number of days over the sampling duration for ATV/RTV 300/100 mg QD+RIB 150 mg twice weekly, i.e. AUC(TAU)/7|Pre-dose (0h) on Days 6, 8, 10, and 11, and post-dose (1h,2h,3h,4h,6h,8h,12h) on Day 10 for RIB 150 mg QD; and pre-dose (0h) on Days 4, 8,11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.|All treated participants who received all doses of RIB as specified per protocol, and were evaluable for analysis.||ng*h/mL||Full Range|Geometric Mean
762051|NCT00646776|Secondary|Number of Participants With MAs in Hematology: Neutrophils + Bands (Absolute), Lymphocytes (Absolute), Monocytes (Absolute), Basophils (Absolute) and Eosinophils (Absolute)|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following hematology MA definitions specify the criteria for the data presented. Neutrophils+bands (absolute): <=1.50 x 10^3 cells/microliter (uL). Lymphocytes (absolute): <0.75 x 10^3 cells/uL or >7.50 x 10^3 cells/uL. Monocytes (absolute): >2.00 x 10^3 cells/uL. Basophils (absolute): >0.40 x 10^3 cells/uL. Eosinophils (absolute): >0.75 x 10^3 cells/uL.|Pre-dose on Day -1 and post-dose on Days 3, 7, 11, 14, 20 and 26 for RIB 150 mg QD; and pre-dose on Day -1 and post-dose on Days 3, 7, 11, 14 and 18 for ATV/RTV 300/100 mg QD + RIB 150 mg twice weekly.|"All treated participants. If a value had not evaluable in the dataset, then these participants were not counted(neutrophils + bands [absolute], monocytes [absolute], basophils [absolute] and eosinophils [absolute])."||Participants|||Number
762052|NCT00646776|Secondary|Number of Participants With Marked Abnormalities (MAs) in Hematology: Hemoglobin, Hematocrit, Platelet Count and Leukocytes|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following hematology MA definitions specify the criteria for the data presented. Hemoglobin/hematocrit: <0.85 x pre-treatment (pre-Rx) value. Platelet count: <0.85 x lower limit of normal (LLN) (or, if pre-Rx value <LLN, then <0.85 x pre-Rx value) or >1.5 x upper limit of normal (ULN). Leukocytes: <0.9 x LLN or >1.2 x ULN (or, if pre-Rx value <LLN, then <0.85 x pre-Rx or >ULN. If pre-Rx value >ULN, then >1.15 x pre-Rx or <LLN).|Pre-dose on Day -1 and post-dose on Days 3, 7, 11, 14, 20 and 26 for RIB 150 mg QD; and pre-dose on Day -1 and post-dose on Days 3, 7, 11, 14 and 18 for ATV/RTV 300/100 mg QD + RIB 150 mg twice weekly.|"All treated participants. If a value had not evaluable in the dataset, then these participants were not counted (hemoglobin and hematocrit)."||Participants|||Number
762053|NCT00646776|Secondary|Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Experienced Adverse Events (AEs) and Experienced Events Leading to Discontinuation.|AEs were defined as new, untoward medical occurrences/worsening of pre-existing medical condition, whether drug-related or not. SAEs were defined as any AE that: resulted in death; was life threatening; resulted in a persistent or significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; was a cancer; or was an overdose. Discontinuation from the study was due either to an AE or was conducted at the investigator's discretion.|From Day 1 to 30 days after the last dose of study drug.|All treated participants.||Participants|||Number
762054|NCT00646776|Secondary|T-half of RTV|T-half was obtained directly from the concentration-time data.|Pre-dose (0h) on Days 4, 8, 11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.|All treated participants who received all doses of RTV as specified per protocol, and were evaluable for analysis.||Hour||Standard Deviation|Mean
762056|NCT00646776|Secondary|AUC(TAU) for RTV|AUC(TAU) was derived from the plasma concentration versus time for RTV, and was calculated by linear and log-linear trapezoidal summations using a mixed log-linear algorithm.|Pre-dose (0h) on Days 4, 8, 11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.|All treated participants who received all doses of RTV as specified per protocol, and were evaluable for analysis.||ng*h/mL||Full Range|Geometric Mean
762057|NCT00646776|Secondary|Cmin of RTV|Cmin was derived from the plasma concentration versus time for RTV.|Pre-dose (0h) on Days 4, 8, 11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.|All treated participants who received all doses of RTV as specified per protocol, and were evaluable for analysis.||ng/mL||Full Range|Geometric Mean
762058|NCT00646776|Secondary|Cmax of RTV|Cmax was derived from the plasma concentration versus time for RTV and was recorded directly from experimental observations for each treatment period.|Pre-dose (0h) on Days 4, 8, 11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.|All treated participants who received all doses of RTV as specified per protocol, and were evaluable for analysis.||ng/mL||Full Range|Geometric Mean
762059|NCT00646776|Secondary|Terminal Elimination Half-life (T-half) of ATV|T-half was obtained directly from the concentration-time data. T-half following doses administered for treatment ATV/RTV 300/100 mg QD+RIB 150 mg twice weekly.|Pre-dose (0h) on Days 4, 8, 11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.|All treated participants who received all doses of ATV as specified per protocol, and were evaluable for analysis.||Hour||Standard Deviation|Mean
762060|NCT00646776|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of ATV|Tmax was derived from the plasma concentration versus time for ATV and was recorded directly from experimental observations for each treatment period.|Pre-dose (0h) on Days 4, 8, 11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.|All treated participants who received all doses of ATV as specified per protocol, and were evaluable for analysis.||Hour||Full Range|Median
762061|NCT00646776|Secondary|AUC(TAU) for ATV|AUC(TAU) was derived from the plasma concentration versus time for ATV, and was calculated by linear and log-linear trapezoidal summations using a mixed log-linear algorithm.|Pre-dose (0h) on Days 4, 8, 11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.|All treated participants who received all doses of ATV as specified per protocol, and were evaluable for analysis.||ng*h/mL||Full Range|Geometric Mean
762062|NCT00646776|Secondary|Cmin of ATV|Cmin was derived from the plasma concentration versus time for ATV.|Pre-dose (0h) on Days 4, 8, 11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.|All treated participants who received all doses of ATV as specified per protocol, and were evaluable for analysis.||ng/mL||Full Range|Geometric Mean
762063|NCT00646776|Secondary|Cmax of ATV|Cmax was derived from the plasma concentration versus time for ATV and was recorded directly from experimental observations for each treatment period.|Pre-dose (0h) on Days 4, 8, 11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.|All treated participants who received all doses of ATV as specified per protocol, and were evaluable for analysis.||ng/mL||Full Range|Geometric Mean
762064|NCT00646776|Primary|Minimum Plasma Concentration (Cmin) of RIB|Cmin was derived from plasma concentration versus time for RIB.|Pre-dose (0h) on Days 6, 8, 10, and 11, and post-dose (1h,2h,3h,4h,6h,8h,12h) on Day 10 for RIB 150 mg QD; and pre-dose (0h) on Days 4, 8,11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.|All treated participants who received all doses of RIB as specified per protocol, and were evaluable for analysis.||ng/mL||Full Range|Geometric Mean
762065|NCT00646776|Primary|Maximum Plasma Concentration (Cmax) of RIB|Cmax was derived from plasma concentration versus time for RIB and was recorded directly from experimental observations for each treatment period.|Pre-dose (0h) on Days 6, 8, 10, and 11, and post-dose (1h,2h,3h,4h,6h,8h,12h) on Day 10 for RIB 150 mg QD; and pre-dose (0h) on Days 4, 8,11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.|All treated participants who received all doses of RIB as specified per protocol, and were evaluable for analysis.||ng/mL||Full Range|Geometric Mean
762066|NCT00646776|Primary|Average Area Under the Plasma Concentration-time Curve for 24 Hours (AUC24avg) for Rifabutin (RIB)|AUC24avg is AUC(0-24 hour) following dosing on Day 10 for RIB 150mg once daily (QD); AUC24avg is the area under the plasma concentration-time curve in 1 dosing interval (AUC[TAU]) divided by the number of days over the sampling duration for ATV/RTV 300/100 mg QD+RIB 150 mg twice weekly, i.e. AUC(TAU)/7.|Pre-dose (0 hours [h]) on Days 6, 8, 10, and 11, and post-dose (1h,2h,3h,4h,6h,8h,12h) on Day 10 for RIB 150 mg QD; and pre-dose (0h) on Days 4, 8,11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.|All treated participants who received all doses of RIB as specified per protocol, and were evaluable for analysis.||nanograms*hour /milliliters (ng*h/mL)||Full Range|Geometric Mean
762067|NCT00646958|Secondary|Number of Patients With Per-Patient Microbiologic Response of Eradicated|The microbiological response at the patient level was considered Eradicated (documented or presumed)if no pathogens were present in repeat cultures taken from the original site of infection or a clinical response of cure precluded the ability to obtain a culturable specimen.|Test of Cure (TOC), day 10-20|Microbiologically Evaluable patients were those that met the entry criteria, received a certain amount of drug, did not receive any additional antibiotics before TOC, presented for a TOC evaluation in the appropriate window, and who had a baseline pathogen that was susceptible to study drug.||Participants|||Number
762068|NCT00646958|Primary|Number of Participants With a Clinical Response of Cure|To qualify as a Cure, participants were required to fulfill the following criteria: all systemic signs and symptoms of uSSSI present at screening were improved or resolved; no further antibiotic therapy was necessary for treatment of uSSSI; and there was no worsening or appearance of new signs and symptoms of uSSSI.|Test of Cure (TOC), day 10-20|Clinically Evaluable participants were those that met the entry criteria, received a certain amount of drug, did not receive any additional antibiotics before Test of Cure (TOC), and who presented for a TOC evaluation in the appropriate window.||Participants|||Number
762076|NCT00647400|Primary|Number of Participants With a 50% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI50 Response)|PASI scores range from 0 (best outcome) to 72 (worst outcome including erythema, induration, desquamation, and area affected). Baseline is defined as the last available PASI value prior to the first dose of study drug (adalimumab or placebo) in Study M04-688 (NCT00338754).|Baseline and 12, 24, 36, 52, 76, 100, 160, and 208 weeks after the first dose of adalimumab|All participants enrolled in this study were included in this intent-to-treat (ITT) analysis. Results are presented as observed.||Participants|||Number
762069|NCT00647270|Secondary|Between Group Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 (Last Observation Carried Forward [LOCF])|The HAQ-DI is a self-reported subject measure of physical function calculated as the mean of 8 category scores: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Each category score is calculated as the maximum of the scores for the questions within the category. The HAQ-DI is expressed on a scale of 0 (without any difficulty) to 3 (unable to do) representing an average score across the category. Scores for at least 6 categories are needed to compute the HAQ score. Changes to lower scores indicate improvement in physical function.|Baseline and Week 12|Full Analysis Set (FAS) - a subset of the intent to treat population used in all efficacy analyses excluding subjects from an Abbott identified Investigator who was non-compliant with the protocol requirements. The FAS of subjects who received at least 1 dose of study drug during Period 2 of the study was used for Period 2 efficacy analyses.||units on a score||Standard Error|Least Squares Mean
762070|NCT00647270|Secondary|Between Group Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 (Observed)|The HAQ-DI is a self-reported subject measure of physical function calculated as the mean of 8 category scores: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Each category score is calculated as the maximum of the scores for the questions within the category. The HAQ-DI is expressed on a scale of 0 (without any difficulty) to 3 (unable to do) representing an average score across the category. Scores for at least 6 categories are needed to compute the HAQ score. Changes to lower scores indicate improvement in physical function.|Baseline and Week 12|Full Analysis Set (FAS) - a subset of the intent to treat population used in all efficacy analyses excluding subjects from an Abbott identified Investigator who was non-compliant with the protocol requirements. The FAS of subjects who received at least 1 dose of study drug during Period 2 of the study was used for Period 2 efficacy analyses.||units on a score||Standard Error|Least Squares Mean
762071|NCT00647270|Secondary|Within Group Mean Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 (Last Observation Carried Forward [LOCF])|The HAQ-DI is a self-reported subject measure of physical function calculated as the mean of 8 category scores: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Each category score is calculated as the maximum of the scores for the questions within the category. The HAQ-DI is expressed on a scale of 0 (without any difficulty) to 3 (unable to do) representing an average score across the category. Scores for at least 6 categories are needed to compute the HAQ score. Changes to lower scores indicate improvement in physical function.|Baseline and Week 12|Full Analysis Set (FAS)-a subset of the intent to treat population used in all efficacy analyses excluding subjects from an Abbott identified Investigator who was non-compliant with protocol requirements. The FAS of subjects who received at least 1 dose of study drug during Period 2 of the study was used for Period 2 efficacy analyses (LOCF).||units on a score||Standard Deviation|Mean
762072|NCT00647270|Secondary|Within Group Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 (Observed)|The HAQ-DI is a self-reported subject measure of physical function calculated as the mean of 8 category scores: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Each category score is calculated as the maximum of the scores for the questions within the category. The HAQ-DI is expressed on a scale of 0 (without any difficulty) to 3 (unable to do) representing an average score across the category. Scores for at least 6 categories are needed to compute the HAQ score. Changes to lower scores indicate improvement in physical function.|Baseline and Week 12|Full Analysis Set (FAS)-a subset of the intent to treat population used in all efficacy analyses excluding subjects from an Abbott identified Investigator who was non-compliant with protocol requirements. The FAS of subjects who received at least 1 dose of study drug during Period 2 of the study was used for Period 2 efficacy analyses (observed).||units on a score||Standard Deviation|Mean
762073|NCT00647270|Primary|The Number of Responders According to the American College of Rheumatology (ACR) 20 Response Criteria at Week 12 Involving the Comparison of Adalimumab 80 mg Monthly Dose Versus Placebo and Adalimumab 40 mg Every Other Week (Eow)|Comparison of adalimumab 80 mg monthly dose versus placebo and adalimumab 40 mg eow in the number of responders with ACR criteria improvement consisting of 20%, (ACR20) reduction in tender or swollen joint counts (TJC or SJC, respectively) and 20% improvement in 3 of the following 5 criteria: [1] physician's global assessment of disease activity (PGA), [2] subject's assessment of disease activity, [3] subject's assessment of pain, [4] subject's assessment of physical disability via a health assessment questionnaire disability index(HAQ-DI), and [5] C-reactive protein (CRP) at each visit|Week 12|Full Analysis Set (FAS) - a subset of the intent to treat population used in all efficacy analyses excluding subjects from an Abbott identified Investigator who was non-compliant with the protocol requirements. The FAS of subjects who received at least 1 dose of study drug during Period 2 of the study was used for Period 2 efficacy analyses.||participants|||Number
762074|NCT00647400|Secondary|Number of Participants With a 90% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI90 Response)|PASI scores range from 0 (best outcome) to 72 (worst outcome including erythema, induration, desquamation, and area affected). Baseline is defined as the last available PASI value prior to the first dose of study drug (adalimumab or placebo) in Study M04-688 (NCT00338754).|Baseline and 12, 24, 36, 52, 76, 100, 160, and 208 weeks after the first dose of adalimumab|All participants enrolled in this study were included in this intent-to-treat (ITT) analysis. Results are presented as observed.||Participants|||Number
762075|NCT00647400|Secondary|Number of Participants With a 75% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI75 Response)|PASI scores range from 0 (best outcome) to 72 (worst outcome including erythema, induration, desquamation, and area affected). Baseline is defined as the last available PASI value prior to the first dose of study drug (adalimumab or placebo) in Study M04-688 (NCT00338754).|Baseline and 12, 24, 36, 52, 76, 100, 160, and 208 weeks after the first dose of adalimumab|All participants enrolled in this study were included in this intent-to-treat (ITT) analysis. Results are presented as observed.||Participants|||Number
762162|NCT00649792|Secondary|Subject Global Impression (SGI)|For the SGI, the potential responses to the effects of the investigational drug during the preceding week were 1=terrible, 2=unhappy, 3=mostly dissatisfied, 4=neutral/ mixed, 5=mostly satisfied, 6=pleased, and 7=delighted.|Visit 1 and every clinic visit thereafter (other than the follow-up visit)|ITT Population. No imputation for missing data||1-7 scale rating||Standard Deviation|Mean
762077|NCT00647556|Secondary|Number of Participants in Each Category of the Investigator Evaluation of Global Response (Improvement) at Week 12 and Week 24|Number of participants in each category of the Investigator Evaluation of Global Response (Improvement) at week 12 and week 24. Investigator Evaluation of Global Response (Improvement) is evaluated on a scale from 0 - 6 (0 = Complete Response, 1 = Almost Complete (~90%) Response, 2 = Marked (~75%) Response, 3 = Moderate (~50%) Response, 4 = Slight (~25%) Response, 5 = No Response and 6 = Worsening) with 0 being best and 6 being worst.|week 12 and week 24|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)||participants|||Number
762078|NCT00647556|Secondary|Number of Participants in Each Category of the Subject Evaluation of Improvement at Week 12 and Week 24|Number of participants in each category of the Subject Evaluation of Improvement at week 12 and week 24. Subject Evaluation of Improvement was evaluated on a scale from 0 - 6 (0 = Complete Improvement, 1 = Almost (~90%) Improvement, 2 = Marked (~75%) Improvement, 3 = Moderate (~50%) Improvement, 4 = Slight (~25%) Improvement, 5 = No Change, 6 = Worse) with 0 being best and 6 being worst.|week 12 and week 24|ITT (Intent to Treat; LOCF (Last Observation Carried Forward)||participants|||Number
762079|NCT00647556|Secondary|Number of Participants Who Improved (a Decrease of at Least One Point) in Overall Integrated Assessment of Photodamage From Baseline to Week 12.|Number of participants who improved in Overall Integrated Assessment of Photodamage from baseline to week 12. Overall Integrated Assessment of Photodamage was evaluated on a scale from 0 - 5 (0 = None, 1 = Minimal, 2 = Mild, 3 = Moderate 4 = Severe and 5 = Very Severe) with 0 being best and 5 being worst.|baseline to week 12|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)||participants|||Number
762080|NCT00647556|Secondary|Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24|Number of participants in each category of the Photonumeric Scale for the Assessment of Photodamage from baseline to week 12 and baseline to week 24. Photonumeric Scale consisted of 9 categories (Fine Wrinkling, Mottled Pigmentation, Irregular Depigmentation, Lentigines, Coarse Wrinkling, Elastosis, Tactile Roughness, Telangiectasia, and Actinic Keratosis. These were evaluated on a scale from 0 - 4 (0 = None, 1 = Minimal, 2 = Mild, 3 = Moderate and 4 = Severe) with 0 being best and 4 being worst.|baseline, week 12 and week 24|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)||participants|||Number
762081|NCT00647556|Primary|Change From Baseline in Overall Integrated Assessment of Photodamage at Week 24|Number of participants who improved (a decrease by at least one point) in Overall Integrated Assessment of Photodamage from baseline to week 24. Overall Integrated Assessment of Photodamage is a scale from 0 - 5 (0 = None, 1 = Minimal, 2 = Mild, 3 - Moderate, 4 = Severe and 5 = Very Severe) with 0 being best and 5 being worst.|baseline to week 24|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)||participants|||Number
762082|NCT00647699|Primary|Mean Change From Baseline in Maximum Keratometry (Kmax)|The primary efficacy parameter was corneal curvature, as measured by maximum keratometry (Kmax) in the study eyes. Study success was defined as a difference of ≥1 D in the mean change in Kmax from baseline to 12 months between the CXL group and control group. Keratometry was measured manually and by pentacam.|baseline,12 months|The ITT (intent to treat) population consisted of all treated subjects, analyzed according to the treatment actually received. For the sham study eyes that received CXL treatment after baseline, the last Kmax measurement recorded prior to receiving CXL treatment was used in the analysis for later time points.||diopters||Standard Deviation|Mean
762083|NCT00647998|Secondary|Hemoglobin||24 hours post-surgery|||gm/dL||Standard Deviation|Mean
762084|NCT00647998|Secondary|CSF S100beta|Cerebrospinal fluid S100beta level|48 hours|||pg/mL||Inter-Quartile Range|Median
762085|NCT00647998|Primary|Death or Neurologic Disability, Defined as an National Institutes of Health Stroke Scale (NIHSS)>4 or American Spinal Injury Association (ASIA) Lower Extermity Motor Score <25|The NIHSS is a validated quasi-ordinal measure of stroke severity. An NIHSS >4 is generally considered moderate or severe. The ASIA Lower Extremity Motor Score is a cumulative total of assessments of strength in 5 muscles in each leg, using the Medical Research Council 0-5 stroke score. ASIA score < 25 is associated with impaired ambulation.|Discharge from the hospital|||Participants|||Count of Participants
762086|NCT00648037|Primary|Safety of Rituximab Prophylaxis|The following stopping rules will be employed to determine that the risks of graft failure, severe GvHD, treatment-related mortality, infection, and EBV-LPD in study patients are not increased over expected. In addition, patients will be removed from study if they develop irreversible non-hematologic Grade III toxicity or any Grade IV toxicity felt to be related or possibly related to study drug.|3 months post transplant|Please see Adverse Event section for more details.||participants|||Number
762087|NCT00648115|Secondary|Test Economic Impact Between Manual Conditions (e.g., Cost-benefit Ratio)|overall economic impact, in dollars, will be evaluated by the following formula: income - healthcare cost - cost of incarceration|12 months|||dollars||Standard Deviation|Mean
762088|NCT00648115|Primary|Time Till Employment in Days|Number of days until first day of competitive employment|12 months|||number of days to first employment||95% Confidence Interval|Mean
762089|NCT00648167|Primary|The Difference in Serum Phosphorus Between Baseline (Day 0) and End of Treatment (Day 28)||28 days|||mg/dL||Standard Deviation|Mean
762090|NCT00641862|Secondary|Childhood Neurodevelopment/Neurocognitive Function|Neurodevelopmental status and neurocognitive function are measured by measured by the cognitive scale of the Bayley scales of infant development, 3rd edition|18 and 30 months||||||
762091|NCT00641862|Secondary|Changes in Maternal Hemoglobin Levels, Maternal Weight Gain and Infant Birth-weight.||Maternal hemoglobin levels will be assessed at weeks 24 and 34 pre-pregnancy and at 6 weeks post-partum. Maternal weight gain will be assessed monthly until delivery and at 6 weeks post-partum. Infant birth-weight will be assessed at birth.||||||
762092|NCT00641862|Primary|Changes in Maternal Serum B12 Concentration From 1st to 3rd Trimester||from 1st to 3rd trimester|||pmol/L||Inter-Quartile Range|Median
762102|NCT00642278|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 12|The table below shows the mean change in FPG from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the least-squares mean change.|Day 1 (Baseline) and Week 12|This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when Week 12 values were missing. The table includes only patients with both baseline and post baseline values.||mmol/L||Standard Deviation|Mean
762093|NCT00642174|Secondary|Inhibition of Platelet Function as Measured by Thromboelastography (TEG)-Platelet Mapping Maximum Amplitude - Adenosine Diphosphate|Thromboelastography (TEG) platelet mapping (MP) maximum amplitude (MA) – Adenosine Diphosphate (ADP) millimeters (mm) at each time point. The TEG-MP MA measures strength of clot formation in whole blood. MA-ADP is the maximal amplitude resulting from fibrin and platelets not blocked by ADP-receptor inhibiting drugs. Fibrin strands in blood sample link a rotating sample cup with a stationary pin suspended by a torsion wire. The degree of platelet contribution to the MA through platelet-fibrin bonding directly influences the magnitude of pin movement and ultimately the amplitude of the tracing.|Baseline, 1 Hour, 4 Hours, and 24 Hours after loading dose, and 24 Hours after last maintenance dose|Pharmacodynamic Population, which included all randomized participants who had blood draws for Inhibition of Platelet Function (IPF) as measured by Thromboelastography (TEG)-Platelet Mapping Maximum Amplitude - Adenosine Diphosphate (ADP), who met compliance criteria, and who had last dose of study drug prior to blood draw for IPF.||millimeters (mm)||95% Confidence Interval|Least Squares Mean
762094|NCT00642174|Secondary|Platelet Reactivity Index (PRI)|Data from the Vasodilator-associated stimulated phosphoprotein assay were reported as the platelet reactivity index (PRI) which was calculated from corrected mean fluorescence intensity (cMFI) following incubation of platelets with either prostaglandin E1 (PGE1) alone or PGE1 plus ADP: Platelet Reactivity Index (%) = [1-(cMFI PGEI+ADP/cMFI PGEI)] x 100. Lower PRI values indicate greater platelet P2Y12 inhibition.|Baseline, 1 Hour, 4 Hours, and 24 Hours after loading dose, and 24 Hours after last maintenance dose|Pharmacodynamic Population, which included all randomized participants who had blood draws for Vasodilator-Associated Stimulated Phosphoprotein (VASP), who met compliance criteria, and who had last dose of study drug prior to the blood draw for inhibition of platelet function as assessed by VASP.||percent inhibition||95% Confidence Interval|Least Squares Mean
762095|NCT00642174|Secondary|Maximum Platelet Aggregation (MPA) as Assessed by Light Transmittance Aggregometry (LTA)|Mean platelet aggregation (MPA) to 5 and 20 µM adenosine diphosphate (ADP) was assessed by light transmittance aggregometry (LTA). Platelet aggregation was monitored for a total of 7 minutes after addition of ADP. Maximum platelet aggregation was the maximal aggregation value achieved during the 7-minute observation period following addition of agonists.|Baseline, 1 Hour, 4 Hours, and 24 Hours after loading dose, and 24 Hours after last maintenance dose|Pharmacodynamic Population, which included all randomized participants who had blood draws for MPA, who met compliance criteria, and who had last dose of study drug prior to the blood draw for MPA.||percent platelet aggregation||95% Confidence Interval|Least Squares Mean
762096|NCT00642174|Secondary|Inhibition of Platelet Aggregation at 1- and 24-Hours After Loading Dose (LD) and 24-Hours After Last Maintenance Dose (LMD) Assessed by Accumetrics VerifyNow™ P2Y12 Assay|Inhibition of platelet aggregation 1- and 24-hours after loading dose and 24-hours after last maintenance dose was administered was assessed using Accumetrics VerifyNow™ P2Y12 assay. Percentage inhibition, as reported by VerifyNow™ P2Y12, was calculated from PRU (rate and extent of ADP-stimulated platelet aggregation) and BASE (estimate of baseline platelet reactivity independent of P2Y12 receptor inhibition [reference values]: rate and extent of Thrombin Receptor-Activated Peptide-stimulated platelet aggregation) values as follows: Percentage (%) inhibition = (1-PRU/BASE) x 100.|1 hour and 24 hours after the loading dose (LD) and 24 hours after the last maintenance dose (LMD)|Pharmacodynamic Population, which included all randomized participants who had blood draws for IPA, who met compliance criteria, and who had last dose of study drug prior to the blood draw for IPA.||percent inhibition||95% Confidence Interval|Least Squares Mean
762097|NCT00642174|Primary|Inhibition of Platelet Aggregation (IPA) 4 Hours After Loading Dose Assessed by Accumetrics VerifyNow™ P2Y12 Assay|The inhibition of platelet aggregation 4 hours after the loading dose was administered was assessed using the Accumetrics VerifyNow™ P2Y12 assay. Percentage inhibition, as reported by VerifyNow™ P2Y12, was calculated from P2Y12 Reaction Unit (PRU) (rate and extent of adenosine diphosphate [ADP]-stimulated platelet aggregation) and BASE (estimate of baseline platelet reactivity independent of P2Y12 receptor inhibition [reference values]: rate and extent of Thrombin Receptor-Activated Peptide-stimulated platelet aggregation) values as follows: Percentage (%) inhibition = (1-PRU/BASE) x 100.|4 hours after loading dose|Pharmacodynamic Population, which included all randomized participants who had blood draws for IPA at 4 hours, who met compliance criteria, and who had last dose of study drug prior to the blood draw for IPA.||percent inhibition||95% Confidence Interval|Least Squares Mean
762098|NCT00642278|Secondary|Percent Change in Body Weight From Baseline to Week 12|The table below shows the mean percent change in body weight from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the least-squares mean change.|Day 1 (Baseline) and Week 12|This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when Week 12 values were missing. The table includes only patients with both baseline and post baseline values.||Percent change||Standard Deviation|Mean
762099|NCT00642278|Secondary|Absolute Change in Body Weight From Baseline to Week 12|The table below shows the mean absolute change in body weight from Baseline to Week 12 for each treatment group.|Day 1 (Baseline) and Week 12|This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when Week 12 values were missing. The table includes only patients with both baseline and post baseline values.||kg||Standard Deviation|Mean
762100|NCT00642278|Secondary|Change in Overnight Urine Glucose/Creatinine Ratio From Baseline to Week 12|The table below shows the mean change in overnight urine glucose/creatinine ratio from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the least-squares mean change.|Day 1 (Baseline) and Week 12|This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when Week 12 values were missing. The table includes only patients with both baseline and post baseline values.||mg/mg||Standard Deviation|Mean
762101|NCT00642278|Secondary|Percentage of Patients With Symptoms of Hypoglycemia|The table below shows the percentage of patients who experienced symptomatic hypoglycemic events between Baseline and Week 12.|Up to Week 12|This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomiy assigned to a treatment group.||Percentage of patients|||Number
762103|NCT00642278|Primary|Change in HbA1c From Baseline to Week 12|The table below shows the mean change in HbA1c from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the least-squares mean change.|Day 1 (Baseline) and Week 12|This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when Week 12 values were missing. The table includes only patients with both baseline and post baseline values.||Percent||Standard Deviation|Mean
762104|NCT00642304|Secondary|Percentage of Participants With Dose Adjustment|A dose adjustment was defined as a change versus the preceding dose. It included dose increase and dose reduction from the dose given at Baseline.|Baseline up to Week 20|ITT population||Percentage of participants|||Number
762105|NCT00642304|Secondary|Percentage of Participants With Blood Transfusion||Baseline up to Week 28|ITT population||Percentage of participants|||Number
762106|NCT00642304|Secondary|Mean Time Spent in Hb Range of 10.5 to 12.5 g/dL During the EEP|The EEP was defined as Week 16 to Week 24.|EEP (Weeks 16 to 24)|ITT population||Days||Standard Deviation|Mean
762107|NCT00642304|Secondary|Percentage of Participants Maintaining Hb Concentration Within Hb Range 10.5 to 12.5 g/dL During the EEP|The EEP was defined as Week 16 to Week 24.|EEP (Weeks 16 to 24)|ITT population||Percentage of participants||95% Confidence Interval|Number
762108|NCT00642304|Secondary|Mean Change in Hb Concentration Between SVP and the EEP|The mean change in the time-adjusted average Hb concentration between the two study periods SVP (Baseline) and EEP is presented. The SVP was defined as Week -4 to Week 0. The EEP was defined as Week 16 to Week 24.|SVP (Week -4 to Week 0) and EEP (Week 16 to Week 24)|ITT population||g/dL||Standard Deviation|Mean
762109|NCT00642304|Primary|Percentage of Participants Maintaining Hb Concentration Within +/-1 Gram Per Deciliter (g/dL) of Their Reference Hb and Between 10.5 to 12.5 g/dL Throughout the Efficacy Evaluation Period (EEP)|The reference Hb value was taken as the time adjusted average of all Hb assessments during the Stability Verification Period (SVP) (Week -4 to Week 0). EEP was from Week 16 to Week 24.|EEP (Weeks 16 to 24)|The Intent- to -treat (ITT) population included all participants who received at least one dose of trial medication at Week 0 and for whom data for at least one follow-up variable (adverse event) was available.||Percentage of participants||95% Confidence Interval|Number
762110|NCT00642356|Secondary|Change From Baseline on the Motor Score of the Quantitative Wearing-Off Questionnaire 9 Item (QWOQ-9)|The QWOQ-9 is a self-rated questionnaire used to assess motor and non-motor symptoms of Parkinson’s disease. The 5 motor symptoms are each measured on a five item (0-4) Likert scale, reflecting the severity of the item from “not present” to “very severe”. The range of possible score values of the motor subscale of the QWOQ-9 is 0 to 20. A higher score indicates greater disability. A negative change score indicates improvement.|Baseline to 15 minutes prior to 2nd dose at Week 8|All subjects that were assessed for efficacy||Units on a scale||Standard Deviation|Mean
762111|NCT00642356|Primary|Change From Baseline on the Non-motor Score of the Quantitative Wearing-Off Questionnaire 9 Item (QWOQ-9)|The QWOQ-9 is a self-rated questionnaire used to assess motor and non-motor symptoms of Parkinson’s disease. The 4 non-motor symptoms are each measured on a five item (0-4) Likert scale, reflecting the severity of the item from “not present” to “very severe”. The range of possible score values of the non-motor subscale of the QWOQ-9 is 0 to 16. A higher score indicates greater disability. A negative change score indicates improvement.|Baseline to 15 minutes prior to 2nd dose at Week 8|All subjects that were assessed for efficacy||Units on a scale||Standard Deviation|Mean
762112|NCT00642369|Primary|Percentage of Rapid Eye Movement Sleep|The primary variable is the change of the percentage of rapid eye movement (REM)sleep from baseline to the 28th day (LOCF).|28 days|For the need of the statistical analysis, the study group and the control group are 30 evaluable patients respectively. Finally, in consideration of 25% un-evaluable patients after randomisation, there should be 80 patients randomised in this study with 40 patients per arm.||percentage of rapid eye movement sleep||Standard Deviation|Mean
762113|NCT00642369|Primary|Percentage of Slow Wave Sleep|The primary variable is the change of percentage of slow wave sleep (SWS) from baseline to the 28th day (LOCF).|28 days|||percentage of slow wave sleep||Standard Deviation|Mean
762114|NCT00642382|Secondary|Secondary Effectiveness Parameters That Will be Evaluated Include the Following That Evaluate Pain, Function, Subject’s Global Assessment, Quality of Life and an Individual Subject Responder Analysis.||At 4, 12 and 26 weeks post 3rd injection||||||
762115|NCT00642382|Primary|The Comparison Between the Agilus Injection and the Saline Control Injection Groups in the Proportion of Subjects Experiencing a Reduction in the Assessment of Pain Determined by the AOS Subscale for Pain.||At 4, 12 and 26 weeks post 3rd injection|Zero patients were analyzed for this study due to the study being closed 2 months after it started. Data were not collected|||||
762116|NCT00642460|Secondary|Part III: Percentage of Participants Who Developed Anti-TCZ Antibodies Associated With The Occurrence of Drug Hypersensitivity Reactions.|Human antibodies against human antibodies (HAHA), anti-tocilizumab antibodies were assessed by immunogenicity techniques from blood samples drawn every two weeks during Part III of the study.|Every 2 weeks from Week 104 to 260|ITT3 population; n=number of participants contributing to the specific statistic||percentage of participants|||Number
762117|NCT00642460|Secondary|Part III: Percentage of Participants Who Developed Antibodies To Tocilizumab During Weeks 104 to 260|Human antibodies against human antibodies (HAHA), anti-tocilizumab antibodies were assessed by immunogenicity techniques from blood samples drawn every two weeks during Part III of the study.|Every 2 weeks from Week 104 to 260|ITT3 population; n=number of participants contributing to the specific statistic||percentage of participants|||Number
762126|NCT00642460|Secondary|Part III: Percentage of Participants Who Maintain JIA ACR30, JIA ACR50, JIA ACR70, JIA ACR90 Response for 6 Months Previous to the Specified Week|JIA ACR core set consisting of 6 components: 1) Physician's global assessment of disease activity VAS, 2) Parent/Patient global assessment of overall well-being VAS, 3) Maximum number of joints with active arthritis, 4) Number of joints with limitation of movement, 5) Erythrocyte Sedimentation Rate, and 6) CHAQ-DI consisting of 30 questions in 8 domains.|Weeks 104, 116, 128, 140, 152, 164, 176, 188, 200, 212, 224, 236, 248 and 260|The Part III ITT3 population||percentage of participants|||Number
762163|NCT00649792|Secondary|Timed 25-Foot Walk (T25FW)||Week 2, 14, 26, continuing every 26 weeks until the Final Visit|ITT Population. No imputation for missing data||feet/seconds||Standard Deviation|Mean
762118|NCT00642460|Secondary|Part III: Percentage of Participants in Clinical Remission Off All Arthritis Medications Except Tocilizumab for 6 Months Prior to Specified Visits|"There were 4 levels of clinical remission defined while the patient remained on tocilizumab as defined below.. After level 1, each successive level required that all the previous level criteria be met:
Level 1: inactive disease criteria have been met at all assessments in the last 6 months (180 days) preceding the timepoint assessment day Level 2: level 1 criteria and no oral corticosteroids received in the last 6 months (180 days) preceding the timepoint assessment day Level 3: level 2 criteria and no methotrexate received in the last 6 months (180 days) preceding the timepoint assessment day Level 4: level 3 criteria and no NSAIDs received for sJIA in the last 6 months (180 days) preceding the timepoint assessment day"|Weeks 116, 128, 140, 152, 164, 188, 200, 212, 224,236,248 and 260|ITT3 population; n=number of participants contributing to the specific statistic||percentage of participants|||Number
762119|NCT00642460|Secondary|Part III: Percentage of Participants on Methotrexate At Baseline in Clinical Remission Off Corticosteroids and Methotrexate for 6 Months Prior to Specified Visits|"There were 4 levels of clinical remission defined while the patient remained on tocilizumab as defined below.. After level 1, each successive level required that all the previous level criteria be met:
Level 1: inactive disease criteria have been met at all assessments in the last 6 months (180 days) preceding the timepoint assessment day Level 2: level 1 criteria and no oral corticosteroids received in the last 6 months (180 days) preceding the timepoint assessment day Level 3: level 2 criteria and no methotrexate received in the last 6 months (180 days) preceding the timepoint assessment day Level 4: level 3 criteria and no NSAIDs received for sJIA in the last 6 months (180 days) preceding the timepoint assessment day"|Weeks 116, 128, 140, 152, 164, 188, 200, 212, 224,236,248 and 260|ITT3 population; n=number of participants contributing to the specific statistic||percentage of participants|||Number
762120|NCT00642460|Secondary|Part III: Percentage of Participants on Corticosteroids at Baseline in Clinical Remission Off All Oral Corticosteroids for 6 Months Prior to Specified Visits|"There were 4 levels of clinical remission defined while the patient remained on tocilizumab as defined below.. After level 1, each successive level required that all the previous level criteria be met:
Level 1: inactive disease criteria have been met at all assessments in the last 6 months (180 days) preceding the timepoint assessment day Level 2: level 1 criteria and no oral corticosteroids received in the last 6 months (180 days) preceding the timepoint assessment day Level 3: level 2 criteria and no methotrexate received in the last 6 months (180 days) preceding the timepoint assessment day Level 4: level 3 criteria and no NSAIDs received for sJIA in the last 6 months (180 days) preceding the timepoint assessment day"|Weeks 116, 128, 140, 152, 164, 188, 200, 212, 224,236,248 and 260|ITT3 population; n=number of participants contributing to the specific statistic||percentage of participants|||Number
762121|NCT00642460|Secondary|Part III: Percentage of Participants in Clinical Remission|"Patients who previously withdrew are excluded Responders are patients who met all of the following criteria for inactive disease at all visits in the 6 months (180 days) prior to and including the visit assessment day: i. Number of active joints = 0. ii. Absence of lymphadenopathy, hepatomegaly or splenomegaly in the nearest non-missing physical examination prior to or after the week assessment day. This could include results outside of the time window.
iii. Absence of symptomatic serositis adverse event. iv. In the 14 days preceding the week assessment day no fever (temperature >=37.5 C) or rash characteristic of sJIA. v. Normal ESR as defined by an ESR <20 mm/hr regardless of age and sex.
vi. iv. Physician global assessment VAS <=10. LOCF rule applied to missing number of active joints, ESR and Physician global assessment VAS. ESR = Erythrocyte Sedimentation Rate. VAS = Visual Analogue Scale. Data presented up to the point of entry into the Alternative Dosing Schedule."|Weeks 116, 128, 140, 152, 164, 188, 200, 212, 224,236,248 and 260|ITT3 population; n=number of participants contributing to the specific statistic||percentage of participants|||Number
762122|NCT00642460|Secondary|Part III: Percentage of Participants With Inactive Disease|"Participants who previously withdrew are excluded.
Responders are participants who met all of the following criteria for inactive disease at the visit assessment day:
i. Number of active joints = 0. ii. Absence of lymphadenopathy, hepatomegaly or splenomegaly in the nearest non-missing physical examination prior to or after the week assessment day. This could include results outside of the time window.
iii. Absence of symptomatic serositis adverse event. iv. In the 14 days preceding the week assessment day no fever (temperature >=37.5 C) or rash characteristic of sJIA.
v. Normal ESR as defined by an ESR <20 mm/hr regardless of age and sex. vi. Physician global assessment VAS <=10. LOCF rule applied to missing number of active joints, ESR and Physician global assessment VAS.
Data presented up to the point of entry into the Alternative Dosing Schedule."|Weeks 104, 116, 128, 140, 152, 164, 188, 200, 212, 224,236,248 and 260|ITT3 population; n=number of participants contributing to the specific statistic||percentage of participants|||Number
762123|NCT00642460|Secondary|Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits|"Values summarized are based on average daily dose on the nominal study day. The prednisone equivalent is used in calculation of oral corticosteroid dose. Participants who withdrew are excluded at the timepoint of this event and at all subsequent visits.
Baseline considered first dose of study treatment."|Every 2 weeks from Week 104 to Week 260|ITT3 population; n=number of participants contributing to the specific statistic||percentage of participants|||Number
762124|NCT00642460|Secondary|Part III: Percentage of Participants on Corticosteroids at Baseline Able to Discontinue Corticosteroids by Weeks 104,116, 128, 140, 152, 164, 176, 188, 200, 212, 224, 236, 248, and 260|"Values summarized are based on average daily dose on the nominal study day. The prednisone equivalent is used in calculation of oral corticosteroid dose. Participants who withdrew are excluded at the timepoint of this event and at all subsequent visits.
Baseline considered first dose of study treatment. Data presented up to entry into the Alternative Dosing Schedule."|Weeks 104,116, 128, 140, 152, 164, 176, 188, 200, 212, 224, 236, 248, and 260|ITT3 population; n=number of participants contributing to the specific statistic||percentage of participants|||Number
762125|NCT00642460|Secondary|Part III: Doses of Oral Corticosteroids|Oral corticosteroid values summarized are based on average daily dose on the nominal study day. The prednisone equivalent is used in calculation of oral corticosteroid dose. Participants who withdrew are excluded at the the visit of withdrawal and all subsequent visits.|Baseline and Weeks 104, 116, 128, 140, 152, 164, 176, 188, 200, 212, 224, 236, 248 and 260|ITT3 population; n=number of participants contributing to the specific statistic||mg/kg/day||Standard Deviation|Mean
762164|NCT00649961|Secondary|To Define the Pharmacokinetic Profile of Melatonin in Preterm Infants.||6 months||||||
762127|NCT00642460|Secondary|Part III: Percentage of Participants With at Least 30%, 50%, 70%, and 90% Improvement in JIA Core Set According to ACR|Percentage of participants with ≥30%, 50%, 70%, and 90% improvement in ACR core set consisting of 6 components: 1) Physician's global assessment of disease activity VAS, 2) Parent/Patient global assessment of overall well-being VAS, 3) Maximum number of joints with active arthritis, 4) Number of joints with limitation of movement, 5) Erythrocyte Sedimentation Rate, and 6) CHAQ-DI consisting of 30 questions in 8 domains.|Weeks 104, 116, 128, 140, 152, 164, 176, 188, 200, 212, 224, 236, 248 and 260|The Part III intent-to-treat (ITT3) population consists of all participants who entered into Part III of the study and received at least one administration of tocilizumab during Part III.||percentage of participants|||Number
762128|NCT00642460|Secondary|Part II: Rate of Serious Adverse Events (SAEs), Serious Infection Adverse Events (AEs), Related SAEs, Macrophage Activation Syndrome, AEs Leading to Withdrawal and Deaths Per 100 Patient Years to Week 104|"Rate of SAEs, Rate of Serious Infection AEs, Rate of Related SAEs (remotely, possibly, probably) to Tocilizumab (TCZ), Rate of Macrophage Activation Syndrome, Rate of AEs leading to withdrawal and Rate of deaths per 100 patient years (PY) were calculated using the formula:
Number of Patient Events / Duration in study (years) * 100.
Multiple occurrences of the same AE in one individual are counted."|104 Weeks|Safety Population- all participants who received at least one dose of study drug and had 1 post-baseline safety assessment. Includes all safety data in the database up to the week 104 infusion based on the date of randomization for each patient. (Last date was 31 May 2011)||Events per 100 patient year|||Number
762129|NCT00642460|Secondary|Part II: Percentage of Participants With Oral Corticosteroid Cessation at Week 104|Percentage is based on only those participants who were on oral corticosteroid at baseline and reached a nominal visit day on which dose was calculated.|Baseline, Week 104|Participants from the Intent to Treat population who withdrew have been excluded at post withdrawal visits.||Percentage of Participants|||Number
762130|NCT00642460|Secondary|Part II: Childhood Health Assessment Questionnaire-Disability Index (CHAQ-DI) Score at Week 104|"Functional ability is assessed using the CHAQ-DI. The questionnaire consists of 30 questions referring to eight domains; dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities. Each domain has at least two component questions and if applicable to the patient there are four possible responses (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, 3 = unable to do).
The CHAQ-DI score is the sum of the domain scores divided by the number of domains that have a non-missing score. This overall score ranges from 0 (best) to 3 (worst)."|Baseline, Week 104|Participants from the Intent to Treat population who withdrew have been excluded at post withdrawal visits.||Score on a scale||Standard Deviation|Mean
762131|NCT00642460|Secondary|Part II: Percentage of Participants With Inactive Disease at Week 104|"Criteria for Inactive Disease:
1) No joints with active arthritis, 2) No fever, rash, serositis, splenomegaly, hepatomegaly (by physical exam) or generalized lymphadenopathy attributable to systemic juvenile idiopathic arthritis (sJIA), 3) Normal Erythrocyte Sedimentation Rate (<20 mm/hour), 4) Physician’s global assessment of disease activity Visual Analog Scale (VAS) indicates no disease activity (where no disease activity is considered to be a score ≤10 mm on a 100 mm VAS)."|Week 104|Participants from the Intent to Treat population who reached time point plus patients who withdrew because of insufficient therapeutic response and are assumed to have been nonresponders.||Percentage of Participants|||Number
762132|NCT00642460|Secondary|Part II: Percentage of Participants With no Active Joints at Week 104|Seventy-one joints were assessed for signs of active arthritis. The percentage of participants with no signs of active arthritis is reported.|Week 104|The Intent to Treat population in Part II includes 112 participants who received at least one dose of study drug. Only those participants who reached this time point are included in the analyses.||Percentage of Participants|||Number
762133|NCT00642460|Secondary|Part II: Number of Active Joints at Week 104|Seventy-one joints were assessed for signs of active arthritis. The mean number of joints with signs of active arthritis is reported.|Week 104|Participants from the Intent to Treat population who reached this time point. No data imputation is applied and patients with missing data are excluded.||Active Joints||Standard Deviation|Mean
762134|NCT00642460|Secondary|Part II: Percentage of Participants With JIA ACR70 and JIA ACR90 Responses Week 104|"The six JIA ACR components consist of: 1)Physician's global assessment of disease activity, 2)Parent/Patient global assessment of overall well-being, 3) Maximum number of joints with active arthritis, 4) Number of joints with limitation of movement, 5) Erythrocyte Sedimentation Rate, and 6) CHAQ-DI.
At an assessment visit a JIA ACR70/90 response in comparison to Baseline is defined as: At least three of the six JIA ACR core components improving by at least 70%/90% and no more than one of the remaining JIA ACR core components worsening by more than 30%."|Baseline, Week 104|Participants from the Intent to Treat population who reached the time point plus patients who withdrew because of insufficient therapeutic response and are assumed to have been non-responders.||Percentage of Participants|||Number
762135|NCT00642460|Secondary|Part I: Percentage of Patients With Anemia at Baseline With a ≥10 g/L Increase in Hemoglobin at Week 6 and Week 12|Part I: Percentage of patients who had anemia (hemoglobin <lower level normal based on sex and age) at Baseline and a ≥10 g/L increase in hemoglobin at Week 6 and at Week 12.|Baseline, Week 6 and Week 12|"Participants from the Intent-to-treat population for whom hemoglobin data available. Patients who withdrew, received escape medication, or for whom the endpoint cannot be determined are classified as non-responders.
LOCF rule applied to missing hemoglobin values at Week 6 and Week 12."||Percentage of participants|||Number
762136|NCT00642460|Secondary|Part I: Percentage of Patients With Rash at Baseline Who Are Free From Rash at Week 12|Percentage of participants who had a rash characteristic of sJIA in the 14 days prior to the baseline visit but no rash characteristic of sJIA in the 14 days preceding the Week 12 visit day.|Baseline, Week 12|Participants from the Intent-to-treat population for whom data was available. Patients who withdrew, received escape medication, or for whom the endpoint cannot be determined are classified as non-responders.||Percentage of participants|||Number
762160|NCT00649792|Secondary|Expanded Disability Status Scale (EDSS)|The EDSS was used to grade patient disability on a scale from 0.0 (normal neurological exam) to 10.0 (death)|The Screening Visit, Visit 6, Final Visit or Early Termination Visit (if applicable)|ITT Population. No imputation for missing data||0-10 rating scale||Standard Deviation|Mean
762161|NCT00649792|Secondary|Clinician's Global Impression (CGI)|The potential responses were 1=very much improved, 2=much improved, 3=somewhat improved, 4=no change, 5=somewhat worse, 6=much worse, and 7=very much worse.|Visit 1 and every clinic visit thereafter|ITT Population. No imputation for missing data||1-7 scale rating||Standard Deviation|Mean
762137|NCT00642460|Secondary|Part I: Percentage of Patients With Minimally Important Improvement in CHAQ-DI Score at Week 12|"Percentage of patients who had at least a 0.13 improvement in CHAQ-DI score from Baseline to Week 12.
The CHAQ-DI questionnaire consists of 30 questions referring to eight domains; dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities. Each domain has at least two component questions and if applicable to the patient there are four possible responses (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, 3 = unable to do)."|Baseline, Week 12|"Intent-to-treat Population. Patients who withdrew, received escape medication, or for whom the endpoint cannot be determined are classified as non-responders.
LOCF rule applied to missing CHAQ-DI Scores at Week 12."||Percentage of participants|||Number
762138|NCT00642460|Secondary|Part I: Change From Baseline in the Pain Visual Analog Scale (VAS) at Week 12|Participants rated their pain by placing a horizontal line on a Visual Analog Scale on a scale of 0 (no pain)- 100 mm (severe pain). The score at 12 weeks minus the score at baseline. A negative number indicates improvement.|Baseline, Week 12|Participants from the Intent-to-treat population who had Pain VAS data available at baseline and week 12. Patients who withdrew, received escape medication, or for whom the endpoint cannot be determined are excluded. LOCF rule applied to missing pain VAS at Week 12.||mm|||Number
762139|NCT00642460|Secondary|Part I: Percentage of Participants With Concomitant Corticosteroid Reduction|"The percentage of participants receiving oral corticosteroids(CS) with a JIA ACR70 response at week 6 or Week 8 who reduced their oral CS dose by at least 20% without subsequent JIA ACR30 flare or occurrence of systemic symptoms at week 12.
At an assessment visit a JIA ACR70 response is defined as: At least three of the six JIA ACR core components improving by at least 70% and no more than one of the remaining JIA ACR core components worsening by more than 30%."|Week 6 or Week 8, Week 12|Participants from the Intent-to-treat population (all randomized participants who received at least one dose of study drug) who were taking oral corticosteroids.||Percentage of participants|||Number
762140|NCT00642460|Secondary|Part I: Percentage of Participants With Changes in Laboratory Indicators: High-sensitivity C-Reactive Protein(hsCRP), Hemoglobin (Hb), Platelets and Leukocytes From Abnormal at Baseline to Normal at Week 12|Percentage of participants with a change from an elevated hsCRP value at baseline to a normal hsCRP value at week 12; a change from anemia (low Hemoglobin) at baseline to a normal hemoglobin value at week 12; a change from thrombocytosis (elevated platelets) at baseline to a normal platelet value at week 12; a change from leukocytosis (elevated white blood cell count) at baseline to a normal white blood cell count at week 12.|Baseline, Week 12|Intent-to-treat population includes all randomized participants who received at least one dose of study drug. 'n' in each of the categories is the number of participants with data available at baseline and week 12 for analyses.||Percentage of participants|||Number
762141|NCT00642460|Secondary|Part I: Percentage of Participants With Fever Due to Systemic Juvenile Idiopathic Arthritis (sJIA) at Baseline Who Are Free of Fever at Week 12|Fever free was defined as no diary temperature recording ≥37.5° Celsius in the preceding fourteen days.|Baseline, Week 12|Participants from the Intent-to-treat population (all randomized participants who received at least one dose of study drug) who had a fever due to Systemic Juvenile Idiopathic Arthritis at baseline.||Percentage of participants|||Number
762142|NCT00642460|Secondary|Part I: Percentage Change From Baseline in JIA Core Set ACR Score Component: Childhood Health Assessment Questionnaire Disability Index (CHAQ-DI)|"Functional ability is assessed using the CHAQ-DI. The questionnaire consists of 30 questions referring to eight domains; dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities. Each domain has at least two component questions and if applicable to the patient there are four possible responses (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, 3 = unable to do).
The CHAQ-DI score is the sum of the domain scores divided by the number of domains that have a non-missing score. This overall score ranges from 0 (best) to 3 (worst)."|Baseline, Week 12|Intent-to-treat population. Patients who withdrew, received escape medication, or for whom the endpoint cannot be determined are excluded. LOCF rule applied to missing JIA ACR core set components at Week 12.||Percentage change|||Number
762143|NCT00642460|Secondary|Part I: Percentage Change From Baseline in JIA Core Set ACR Score Component: Erythrocyte Sedimentation Rate|Erythrocyte Sedimentation Rate (ESR) is an acute phase reactant measured in mm/hour.|Baseline, Week 12|Intent-to-treat population. Patients who withdrew, received escape medication, or for whom the endpoint cannot be determined are excluded. LOCF rule applied to missing JIA ACR core set components at Week 12.||Percentage change|||Number
762144|NCT00642460|Secondary|Part I: Percentage Change From Baseline in JIA Core Set ACR Score Component: Number of Joints With Limitation of Movement|The maximum number of joints with limitation of movement is 67 and these are defined as those in the joint assessment with ‘limitation of motion’.|Baseline, Week 12|Intent-to-treat population. Patients who withdrew, received escape medication, or for whom the endpoint cannot be determined are excluded. LOCF rule applied to missing JIA ACR core set components at Week 12.||Percentage change|||Number
762145|NCT00642460|Secondary|Part I: Percentage Change From Baseline in JIA Core Set ACR Score Component: Maximum Number of Joints With Active Arthritis|"The maximum number of joints with active arthritis is 71 and these are defined as those in the joint assessment with: swelling present or pain present and limitation of motion.
The joint assessment is performed by an independent assessor, who is not the treating physician, blinded to all other aspects of the patient’s efficacy and safety data."|Baseline, Week 12|Intent-to-treat population. Patients who withdrew, received escape medication, or for whom the endpoint cannot be determined are excluded. LOCF rule applied to missing JIA ACR core set components at Week 12.||Percentage change|||Number
762146|NCT00642460|Secondary|Part I: Percentage Change From Baseline in JIA Core Set ACR Score Component: Parent/Patient Global Assessment of Overall Well-being|The Parent/Patient global assessment of overall well-being is a VAS. The scale is a 0 to 100 mm horizontal scale, the extreme left end of the line represents ‘very well’ (i.e. symptom-free and no arthritis disease activity) and the extreme right end represents ‘very poor’ (i.e. maximum arthritis disease activity). This item is completed by the patient or parent/guardian as appropriate.|Baseline, Week 12|Intent-to-treat population. Patients who withdrew, received escape medication, or for whom the endpoint cannot be determined are excluded. LOCF rule applied to missing JIA ACR core set components at Week 12.||Percentage change|||Number
762165|NCT00649961|Primary|To Find the Dose of Melatonin Required to Achieve Physiological Blood Levels in the Preterm Infants Similar to That of the Mother.||6 months|||pg/ml||Full Range|Median
762147|NCT00642460|Secondary|Part I: Percentage Change From Baseline in JIA Core Set ACR Score Component: Physician's Global Assessment of Disease Activity|Physician's Global Assessment of disease activity is a Visual Analog Scale. The scale is 0 to 100 mm horizontal scale, the extreme left end of the line represents ‘arthritis inactive’ (i.e. symptom-free and no arthritis symptoms) and the extreme right end represents ‘arthritis very active’. This item is completed by the treating physician.|Baseline, Week 12|Intent-to-treat population. Patients who withdrew, received escape medication, or for whom the endpoint cannot be determined are excluded. Last observation carried forward (LOCF) rule applied to missing JIA ACR core set components at Week 12.||Percentage change|||Number
762148|NCT00642460|Secondary|Part I: Percentage of Participants With JIA Core Set ACR 30/50/70/90 Response at Week 12|"The six JIA ACR components consist of: 1) Physician's global assessment of disease activity, 2) Parent/Patient global assessment of overall well-being, 3) Maximum number of joints with active arthritis, 4) Number of joints with limitation of movement, 5) Erythrocyte Sedimentation Rate, and 6) CHAQ-DI.
At an assessment visit a JIA ACR30/50/70/90 response in comparison to Baseline is defined as: At least three of the six JIA ACR core components improving by at least 30%/50%/70%/90% and no more than one of the remaining JIA ACR core components worsening by more than 30%."|Baseline, Week 12|Intent-to-treat population includes all randomized participants who received at least one dose of study drug.||Percentage of participants|||Number
762149|NCT00642460|Primary|Part II: Percentage of Participants With Decreases in Oral Corticosteroid Dose at Week 104|Percentage of participants with ≥20 percent, ≥50 percent, ≥75 percent and ≥90 percent decreases in oral corticosteroid dose (mg/kg/day) from baseline.|Baseline, Week 104|Includes only participants on oral corticosteroids at baseline.||Percentage of participants|||Number
762150|NCT00642460|Primary|Part I: Percentage of Participants With ≥30% Improvement in Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Core Set and Absence of Fever|"Percentage of participants with ≥30% improvement in ACR core set consisting of 6 components: 1) Physician's global assessment of disease activity Visual Analog Scale (VAS), 2) Parent/Patient global assessment of overall well-being VAS, 3) Maximum number of joints with active arthritis, 4) Number of joints with limitation of movement, 5) Erythrocyte Sedimentation Rate, and 6) Childhood Health Assessment Questionnaire- Disability Index (CHAQ-DI) consisting of 30 questions in 8 domains.
Absence of fever was defined as no diary temperature recording ≥37.5° Celsius in the preceding seven days."|Baseline, Week 12|Intent-to-treat population includes all participants who had at least one dose of study drug.||Percentage of participants|||Number
762151|NCT00649389|Secondary|Change in Seated Systolic Blood Pressure From Baseline to Week 12||Baseline to week 12|||mm Hg||Standard Deviation|Mean
762152|NCT00649389|Secondary|Change in Mean 24-hour Ambulatory Blood Pressure From Baseline to Week 12 or Early Termination||Baseline to 12 weeks or early termination|The ABPM Analysis Set included 440 subjects who provided consent to participate in the ABPM sub-study and who were to provide ABPM measurements prior to and after randomization. Those analyzed is the number who had values at both baseline and 12 weeks or early termination||mm Hg||Standard Deviation|Mean
762153|NCT00649389|Secondary|Percentage of Subjects Who Reached Blood Pressure Goal (<140/90 mmHg; <130/80 mmHg for Subjects With Diabetes, Chronic Renal Disease, or Chronic Cardiovascular Disease)by 12 Weeks||Baseline to 12 weeks|The full analysis set consists of subjects who received at least 1 dose of study medication and had a baseline and at least one post-dose assessment of seated diastolic blood pressure||Percentage of subjects|||Number
762154|NCT00649389|Primary|Change From Baseline to Week 12 in Seated Diastolic Blood Pressure (SeDBP).||baseline to 12 weeks|The full analysis set consists of subjects who received at least 1 dose of study medication and had a baseline and at least one post-dose assessment of SeDBP||mm Hg||Standard Deviation|Mean
762155|NCT00649428|Primary|Evaluator Wrinkle Severity Assessment Responders|A responder was defined as a two point improvement on the blinded Evaluator's live assessment of each of the bilateral nasolabial fold wrinkles at rest using the 6-point ordinal Lemperle Wrinkle Severity Scale. On the Lemperle scale, a score of 5 (Very Deep Wrinkle) is worst and a score of 0 (No Visible Wrinkle) is best.|Baseline (prior to first treatment) and 6 months after last treatment|Analysis population was the ITT population, defined as all randomized subjects.||participants|||Number
762156|NCT00649428|Secondary|Evaluator Wrinkle Severity Assessment Responders|A responder was defined as a two point improvement on the blinded Evaluator's live assessment of each of the bilateral nasolabial fold wrinkles at rest using the 6-point ordinal Lemperle Wrinkle Severity Scale. On the Lemperle scale, a score of 5 (Very Deep Wrinkle) is worst and a score of 0 (No Visible Wrinkle) is best.|Baseline (prior to first treatment) compared to 3rd treatment visit, 2 and 4 months post final treatment|Analysis population was the ITT population, defined as all randomized subjects.||participants|||Number
762157|NCT00649428|Secondary|Subject Wrinkle Assessment Responders|A two point improvement on the Subject's live assessment of the wrinkles of the lower part of the face as compared to baseline on the Subject Wrinkle Assessment was considered a responder. The Subject Wrinkle Assessment scale was a five point scale with a score of -2 (Very Dissatisfied) being the worst and a score of +2 (Very Satisfied) being the best.|Baseline (prior to first treatment) compared to 3rd treatment visit, 2 and 4 months post final treatment|Analysis population was the ITT population, defined as all randomized subjects.||participants|||Number
762158|NCT00649428|Primary|Subject Wrinkle Assessment Responders|A two point improvement on the Subject's live assessment of the wrinkles of the lower part of the face as compared to baseline on the Subject Wrinkle Assessment was considered a responder. The Subject Wrinkle Assessment scale was a five point scale with a score of -2 (Very Dissatisfied) being the worst and a score of +2 (Very Satisfied) being the best.|Baseline (prior to first treatment) and 6 months post final treatment|Analysis population was the ITT population, defined as all randomized subjects.||participants|||Number
762159|NCT00649792|Primary|Summary of Treatment Emergent Adverse Events (TEAE).|All adverse events reported were treatment emergent. Therefore, events that had a date of onset, or worsening, on or after the start of the open-label drug and up to 14 days after the last dose (for non-serious events) or up to 30 days after the last dose (for SAEs) were summarized. Any abnormal clinically significant changes in physical examination, medical history, clinical laboratory testing, 12-lead ECG, and standard EEG testing were captured as adverse events.|up to 40 months|Safety Population. No imputation for missing data||participants|||Number
767738|NCT00697593|Primary|Hematology - Lymphocytes|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 3 participants missing values||x10^9/L||Standard Deviation|Mean
762166|NCT00650078|Secondary|Relative Reduction of Morning Stiffness|Data for the duration of morning stiffness were obtained from patient diaries. Duration of morning stiffness was the difference between the time of resolution of morning stiffness and the time of wake-up. Duration of morning stiffness is the average of the morning stiffness duration (minutes) over the last 7 days prior to visit day (including day of visit). If more than 4 assessments were missing, then the duration was set to missing. Baseline was the value recorded at Week -1 (Visit 0).|Week 12|Modified Intention to Treat (mITT) efficacy population included all patients who were randomized and received at least 1 dose of study medication. Patients were analyzed according to the treatment to which they were intended to be randomized. Excludes those participants with missing data. Analysis used last observation carried forward imputation.||Relative Change from Baseline (%)||95% Confidence Interval|Median
762167|NCT00650078|Primary|ACR 20 Response Rate at Visit 4|"Responders were defined as patients whose improvement from baseline to Visit 4 (Week 12) fulfilled all 3 of the following criteria:
> 20% reduction in the tender joint count (0-28)
> 20% reduction in the swollen joint count (0-28)
> 20% reduction in 3 out of the 5 following additional measures:
Patient’s assessment of pain
Patient’s global assessment of disease activity
Physician’s global assessment of disease activity
Functional Disability Index of the Health Assessment Questionnaire
C-reactive protein or erythrocyte sedimentation rate"|Week 12|Modified Intention to Treat (mITT) efficacy population included all patients who were randomized and received at least 1 dose of study medication. Patients were analyzed according to the treatment to which they were intended to be randomized. All missing values were imputed as non-responders.||participants|||Number
762168|NCT00650091|Post-Hoc|Change in Forced Vital Capacity|Change from Baseline in Forced Vital Capacity at 15, 30, 45, and 60 weeks (units in liters)|Baseline, 15, 30, 45, 60 week|Analysis population includes participants from the amended study design only.||liters||Standard Deviation|Mean
762169|NCT00650091|Secondary|Number of Participants With Maintained Forced Vital Capacity Response|Maintained forced vital capacity response was a binary variable taking on a value of 1 for participants with higher FVC % predicted at week 60 compared to baseline.|Measured at Week 60|Analysis population includes participants from the amended study design only.||participants|||Number
762170|NCT00650091|Secondary|Respiratory Infections||Measured at Week 60|Analysis population includes participants from the amended study design only.||events|||Number
762171|NCT00650091|Secondary|Acute Exacerbations|"The following 3 criteria will define acute exacerbations in subjects with acute worsening of their respiratory conditions:
1. Clinical (all of the following required): A) Unexplained worsening of dyspnea or cough within 30 days, triggering unscheduled medical care (e.g., emergency room, clinic, study visit, hospitalization). B) No clinical suspicion or overt evidence of cardiac event, pulmonary embolism, or deep venous thrombosis to explain acute worsening of dyspnea. C) No pneumothorax."|Measured at Week 60|Analysis population includes participants from the amended study design only.||events|||Number
762172|NCT00650091|Secondary|Disease Progression|"The time-to-death or a 10% decline in FVC will be defined as the time-to-disease progression.
The 10% decline in FVC from enrollment must be confirmed on 2 consecutive visits no less than 6 weeks apart. For subjects with 2 consecutive visits with a 10% decline in FVC, the time-to-disease progression will be defined as the time interval between enrollment and the initial visit with a 10% FVC decline."|Measured at Week 60|Analysis population includes participants from the amended study design only.||percentage of participants||95% Confidence Interval|Number
762173|NCT00650091|Primary|Overall Change in Forced Vital Capacity|Change from Baseline in Forced Vital Capacity at 60 weeks (units in liters)|Measured as the estimated change from baseline to Week 60|Analysis population includes participants from the amended study design only.||liters||95% Confidence Interval|Mean
762174|NCT00650104|Secondary|Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Maintained Responder Population)|The Clinical Global Impression (CGI) scale comprises the following three components (CGI-Severity, CGI-Improvement, Index); where only the CGI-S and CGI-I were assessed in this study. CGI-I is a global improvement scale that scores the clinician’s view of the participant’s global functioning prior to and after initiating a study medication from 1 (very much improved) to 7 (very much worse). 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse.|Week 2, Month 12, Month 78|"Maintained Responder Population. Various n values are the result of participant attrition."||participants|||Number
762175|NCT00650104|Secondary|Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Responder Population)|The Clinical Global Impression (CGI) scale comprises the following three components (CGI-Severity, CGI-Improvement, Index); where only the CGI-S and CGI-I were assessed in this study. CGI-I is a global improvement scale that scores the clinician’s view of the participant’s global functioning prior to and after initiating a study medication from 1 (very much improved) to 7 (very much worse). 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse.|Week 2, Month 12, Month 78|"Responder Population. Various n values are the result of participant attrition."||participants|||Number
762176|NCT00650104|Secondary|Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (ITT Population)|The Clinical Global Impression (CGI) scale comprises the following three components (CGI-Severity, CGI-Improvement, Index); where only the CGI-S and CGI-I were assessed in this study. CGI-I is a global improvement scale that scores the clinician’s view of the participant’s global functioning prior to and after initiating a study medication from 1 (very much improved) to 7 (very much worse). 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse.|Week 2, Month 12, Month 78|"Intent-to-Treat (ITT) Population. Various n values are the result of participant attrition."||participants|||Number
762177|NCT00650104|Secondary|Unified Parkinson’s Disease Rating Scale (UPDRS) Motor Examination Score (Maintained Responder Population)|Two of the six UPDRS sections (Part II, Activities of Daily Living (ADL); Part III, Motor Examination) were assessed in this study. The Motor Exam has 17 items, some of which are assessed in both the left and right extremities. Each item has a choice of 5 responses that are numerically scored 0-4 (0 as the least severe, 4 as the most severe). The final score is a sum of the 17 items, with some sections requiring multiple grades assigned to each extremity, and has a value ranging from 0 (no motor impairment) to 108 (severe motor impairment).|Screening and Month 78|"Maintained Responder Population. Various n values are the result of participant attrition."||points on a scale||Standard Deviation|Mean
767739|NCT00697593|Primary|Hematology - Monocytes|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 3 participants missing values||x10^9/L||Standard Deviation|Mean
762178|NCT00650104|Secondary|Unified Parkinson’s Disease Rating Scale (UPDRS) Motor Examination Score (Reponder Population)|Two of the six UPDRS sections (Part II, Activities of Daily Living (ADL); Part III, Motor Examination) were assessed in this study. The Motor Exam has 17 items, some of which are assessed in both the left and right extremities. Each item has a choice of 5 responses that are numerically scored 0-4 (0 as the least severe, 4 as the most severe). The final score is a sum of the 17 items, with some sections requiring multiple grades assigned to each extremity, and has a value ranging from 0 (no motor impairment) to 108 (severe motor impairment).|Screening and Month 78|"Responder Population. Various n values are the result of participant attrition."||points on a scale||Standard Deviation|Mean
762179|NCT00650104|Secondary|Unified Parkinson’s Disease Rating Scale (UPDRS) Motor Examination Score (ITT Population)|Two of the six UPDRS sections (Part II, Activities of Daily Living (ADL); Part III, Motor Examination) were assessed in this study. The Motor Exam has 17 items, some of which are assessed in both the left and right extremities. Each item has a choice of 5 responses that are numerically scored 0-4 (0 as the least severe, 4 as the most severe). The final score is a sum of the 17 items, with some sections requiring multiple grades assigned to each extremity, and has a value ranging from 0 (no motor impairment) to 108 (severe motor impairment).|Screening and Month 78|"Intent-to-Treat (ITT) Population. Various n values are the result of participant attrition."||points on a scale||Standard Deviation|Mean
762180|NCT00650104|Secondary|Unified Parkinson’s Disease Rating Scale (UPDRS) Total Activities of Daily Living Scores (Maintained Responder Population)|The UPDRS is a clinician-based scale used to assess the longitudinal course of PD. Two of the six sections were assessed (Part II, Activities of Daily Living (ADL); Part III, Motor Examination). Both consist of a number of items (ADL, 13 items; Motor Exam., 17 items), and each item has a choice of 5 responses that are numerically scored 0-4, with 0 as the least severe response and 4 as the most severe response. ADL final score is a sum of the 13 items and may have a value between 0 (no impairment of overall activities) and 52 (severe impairment of overall activities). LTT, long-term treatment.|Screening; Months 3, 9, 15, 27, and 78|Maintained Responder : subset of the Responder Population, which was maintained or further decreased for a minimum of 4 weeks whilst the participant received a stable or decreasing dose of study medication. Various “n” values are the result of participant attrition.||points on a scale||Standard Deviation|Mean
762181|NCT00650104|Secondary|Unified Parkinson’s Disease Rating Scale (UPDRS) Total Activities of Daily Living Score (Responder Population)|The UPDRS is a clinician-based scale used to assess the longitudinal course of PD. Two of the six sections were assessed (Part II, Activities of Daily Living (ADL); Part III, Motor Examination). Both consist of a number of items (ADL, 13 items; Motor Exam., 17 items), and each item has a choice of 5 responses that are numerically scored 0-4, with 0 as the least severe response and 4 as the most severe response. ADL final score is a sum of the 13 items and may have a value between 0 (no impairment of overall activities) and 52 (severe impairment of overall activities). LTT, long-term treatment.|Screening; Months 3, 9, 15, 27, and 78|Responder: a subset of the ITT Population containing those participants who had a score of 1 (very much improved) or 2 (much improved) on the clinical global impression (CGI) scale during the study. CGI-I scores (1 to 7 [very much worse]) the participant’s condition relative to baseline. Various “n” values are the result of participant attrition.||points on a scale||Standard Deviation|Mean
762182|NCT00650104|Primary|Number of Participants With the Indicated Number of Adverse Events (AEs)|AEs, defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, were collected to obtain data on the safety, tolerability, and benefit of ropinirole XL. Serious Adverse Events (SAEs), defined as AEs that are either fatal, life threatening, disabling/incapacitating, resulting in hospitalization or prolongation of a hospital stay, a congenital abnormality/birth defect, or any important medical occurrence that the investigator regards as serious based on medical judgment, were also collected. st. med., study medication.|Every study visit from baseline to market availability (Month 78)|"All participants who received at least one dose of study medication. The treatment-emergent Study 196 AEs were defined as occurring during initial titration or long-term treatment or follow up."||participants|||Number
762183|NCT00650104|Primary|Unified Parkinson’s Disease (PD) Rating Scale (UPDRS) Total Activities of Daily Living Scores (Intent-to-Treat Population)|The UPDRS is a clinician-based scale used to assess the longitudinal course of PD. Two of the six sections were assessed (Part II, Activities of Daily Living (ADL); Part III, Motor Examination). Both consist of a number of items (ADL, 13 items; Motor Exam., 17 items), and each item has a choice of 5 responses that are numerically scored 0-4, with 0 as the least severe response and 4 as the most severe response. ADL final score is a sum of the 13 items and may have a value between 0 (no impairment of overall activities) and 52 (severe impairment of overall activities). LTT, long-term treatment.|Screening; Week 4; Months 3, 9, 15, 21, 27, 33, 39, 45, 51, 57, 63, 69, 75, and 78|Intent-to-Treat (ITT) Population: all participants who received at least one dose of study medication and who had at least one treatment period evaluation for any parameter were included in the evaluation of the therapeutic benefit. Various “n” values are the result of participant attrition.||points on a scale||Standard Deviation|Mean
762184|NCT00650260|Primary|Percentage of Patients With a Post Operative Sublingual Temperature Above 36 Degrees Celcius|Percent of subjects with an initial post anesthesia care unit sublingual temperature of ≥ 36º C|Upon entry to the post anesthesia care unit|||Percentage of participants|||Number
762185|NCT00650260|Primary|Percent of Subjects With an Initial PACU Sublingual Temperature of ≥ 36º C.||Temp taken just prior to surgery|Per protocol, sample size calculations indicate that a total sample size of 42 patients will be necessary to evaluate the primary outcome at an adjusted alpha = 0.05 with 80% power.||Percentage of participants|||Number
762186|NCT00650260|Secondary|Median Post Anesthesia Care Unit Sublingual Temperature||Upon arrival to the post anesthesia care unit|||Degrees Celcius||Full Range|Median
762187|NCT00650260|Secondary|Average Intraoperative Esophageal Temperature|Average esophageal temperature for the first 70 minutes of surgery following induction of anesthesia.|Intraoperative 0-70 minutes|||Degrees Celcius||Full Range|Mean
762188|NCT00650260|Secondary|Comparison of the Core Body Temperatures at 60 Minutes Post Anesthesia Induction,as Assessed by Esophageal Probe.|Average core body temperature measured with an esophageal probe at 60 minutes post-induction|60 minutes post anesthesia induction|||degrees celcius||Standard Deviation|Mean
762189|NCT00650260|Primary|Percent of Patients With an Average Intraoperative Temperature Greater Than or Equal to 36 Celcius||Intraoperative Period|||percentage of participants|||Number
762191|NCT00650546|Primary|Number of Patients With Improvement in Liver Histology After Treatment With Exenatide|Number of patients with liver histology improved with exenatide. The improvement of liver histology was defined as (1) no worsening of the fibrosis score, (11) improved score by at least one point in hepatocyte ballooning, and (111) either (a) improvement in NAS (NAFLD Activity Score) by two points spread across as least two of the three NAS components, or by (B)post-treatment NAS<3.|between baseline and 24-28 weeks after initiating treatment|||participants|||Number
762192|NCT00650585|Primary|Self-reported Lifetime Inhalant Use|Students completed an 81-item self-report questionnaire. To assess lifetime use, we asked if the respondent had ever used inhalants (yes or no).|measured approximately 30 days after intervention completed|Data were cleaned to remove cases with logical inconsistencies which decreased our sample by 3.6% of respondents at pretest and 7.5% at post-test. Missing covariate data were imputed using the Expectation Maximization (EM) algorithm. Missing data were imputed using the EM algorithms implemented in the Missing Value Analysis module in SPSS 13.0.||participants|||Number
762193|NCT00650585|Primary|Self-reported Lifetime Marijuana Use|Students completed an 81-item self-report questionnaire. To assess lifetime use, we asked if the respondent had ever used marijuana (yes or no).|measured approximately 30 days after intervention completed|Data were cleaned to remove cases with logical inconsistencies which decreased our sample by 3.6% of respondents at pretest and 7.5% at post-test. Missing covariate data were imputed using the Expectation Maximization (EM) algorithm. Missing data were imputed using the EM algorithms implemented in the Missing Value Analysis module in SPSS 13.0.||participants|||Number
762194|NCT00650585|Primary|Self-reported Lifetime Cigarette Use|Students completed an 81-item self-report questionnaire. To assess lifetime use, we asked if the respondent had ever smoked cigarettes (yes or no).|measured approximately 30 days after intervention completed|Data were cleaned to remove cases with logical inconsistencies which decreased our sample by 3.6% of respondents at pretest and 7.5% at post-test. Missing covariate data were imputed using the Expectation Maximization (EM) algorithm. Missing data were imputed using the EM algorithms implemented in the Missing Value Analysis module in SPSS 13.0.||participants|||Number
762195|NCT00650585|Primary|Self-reported Lifetime Alcohol Use|Students completed an 81-item self-report questionnaire. To assess lifetime use, we asked if the respondent had ever used alcohol (yes or no).|measured approximately 30 days after intervention completed|Data were cleaned to remove cases with logical inconsistencies which decreased our sample by 3.6% of respondents at pretest and 7.5% at post-test. Missing covariate data were imputed using the Expectation Maximization (EM) algorithm. Missing data were imputed using the EM algorithms implemented in the Missing Value Analysis module in SPSS 13.0.||participants|||Number
762196|NCT00650585|Primary|Self-reported 30-day Inhalant Use|Students completed an 81-item self-report questionnaire. They were asked on how many days they had used inhalants in the previous 30 days. Response options included “none,” “1 or 2 days in the last month,” “3 to 5 days in the last month,” “6 to 19 days in the last month,” and “20 or more days in the last month.” Response options were dichotomized into none and at least one day.|measured approximately 30 days after intervention completed|Data were cleaned to remove cases with logical inconsistencies which decreased our sample by 3.6% of respondents at pretest and 7.5% at post-test. Missing covariate data were imputed using the Expectation Maximization (EM) algorithm. Missing data were imputed using the EM algorithms implemented in the Missing Value Analysis module in SPSS 13.0.||participants|||Number
762197|NCT00650585|Primary|Self-reported 30-day Marijuana Use|Students completed an 81-item self-report questionnaire. They were asked on how many days they had used marijuana in the previous 30 days. Response options included “none,” “1 or 2 days in the last month,” “3 to 5 days in the last month,” “6 to 19 days in the last month,” and “20 or more days in the last month.” Response options were dichotomized into none and at least one day.|measured approximately 30 days after intervention completed|Data were cleaned to remove cases with logical inconsistencies which decreased our sample by 3.6% of respondents at pretest and 7.5% at post-test. Missing covariate data were imputed using the Expectation Maximization (EM) algorithm. Missing data were imputed using the EM algorithms implemented in the Missing Value Analysis module in SPSS 13.0.||participants|||Number
762198|NCT00650585|Primary|Self-reported 30-day Use of Cigarettes|Students completed an 81-item self-report questionnaire. They were asked on how many days they had smoked cigarettes in the previous 30 days. Response options included “none,” “1 or 2 days in the last month,” “3 to 5 days in the last month,” “6 to 19 days in the last month,” and “20 or more days in the last month.” Response options were dichotomized into none and at least one day.|measured approximately 30 days after intervention completed|Data were cleaned to remove cases with logical inconsistencies which decreased our sample by 3.6% of respondents at pretest and 7.5% at post-test. Missing covariate data were imputed using the Expectation Maximization (EM) algorithm. Missing data were imputed using the EM algorithms implemented in the Missing Value Analysis module in SPSS 13.0.||participants|||Number
762199|NCT00650585|Primary|Self-reported 30-day Use of Alcohol|Students completed an 81-item self-report questionnaire. They were asked on how many days they had used alcohol in the previous 30 days. Response options included “none,” “1 or 2 days in the last month,” “3 to 5 days in the last month,” “6 to 19 days in the last month,” and “20 or more days in the last month.” Response options were dichotomized into none and at least one day.|measured approximately 30 days after intervention completed|Data were cleaned to remove cases with logical inconsistencies which decreased our sample by 3.6% of respondents at pretest and 7.5% at post-test. Missing covariate data were imputed using the Expectation Maximization (EM) algorithm. Missing data were imputed using the EM algorithms implemented in the Missing Value Analysis module in SPSS 13.0.||Participants|||Number
762216|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
767740|NCT00697593|Primary|Hematology - Basophils|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 3 participants missing values||x10^9/L||Standard Deviation|Mean
762200|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score|The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762201|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score|The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762202|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score|The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762203|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score|The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762204|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score|The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.|Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762205|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score|The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762206|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score|The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
764982|NCT00673127|Secondary|Time to Progression|Duration of time from treatment initiation until documented progression (PSA or Disease progression)|Duration of time from treatment initiation until documented progression. Maximum 32 months|||months||95% Confidence Interval|Median
762207|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score|The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762208|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score|The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762209|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score|SF-36V2 is a generic 36-item generic health status measure covering 2 summary measures: physical component summary (PCS) and mental health component score (MCS); it consists of 8 subscales. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have choices per item. Scoring is done for both MCS subscale scores and summary scores; for each, the range is 0 (worst) to 100 (best).|Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762210|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762211|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762212|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762213|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762214|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762215|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762217|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762218|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762219|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762220|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762221|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762222|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762223|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762224|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762225|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762336|NCT00650845|Secondary|Percent Change of Serum Creatinine Level From Baseline to 72±24 Hours After Examination, in the Full Analysis Set Population.|Serum creatinine levels were measured at baseline and at 72±24 hours after examination. The percentage of change in creatinemia from baseline was calculated for both the Dotarem® and the non-enhanced groups.|Baseline pre MRI and 3 days post MRI|Full analysis set population:all included patients with a pre and post-procedure blood sample for creatinine measurement.||Percentage of change from baseline||Standard Deviation|Mean
762226|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762227|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762228|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762229|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762230|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762231|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762232|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762233|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762234|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762337|NCT00650845|Primary|Number of Patients Presenting Contrast-induced Nephropathy as Defined by an Increase in Serum Creatinine Levels of a Least 25% Over Baseline Levels, in the Full Analysis Set Population.|Comparing the number of patients experiencing an increase of creatinine of at least 25% over baseline levels after Dotarem®-enhanced MRI and after non-enhanced MRI in patients with at least a moderate renal insufficiency.|baseline pre MRI and 3 days post MRI|Full analysis set population: all included patients with a pre and post-procedure blood sample for creatinine measures.||Number of patients|||Number
762235|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762236|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762237|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762238|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762239|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762240|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762241|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762242|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762243|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762338|NCT00650858|Secondary|2.) 90 and 180 -Day GOS, Rankin, Stroke Impact Scale (Stage 2 Only).||90 and 180 days||||||
762339|NCT00650858|Primary|Rate of Symptomatic Bleeding Events|The rate of symptomatic brain bleeding events were recorded to determine the safety of intraventricular administrations of rt-PA. If 35% or more subjects experienced a symptomatic bleeding event prior to the 30-day follow-up visit, the study would have been stopped for a full DSMB review.|30-days|||participants|||Number
762244|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762245|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762246|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762247|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762248|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762249|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762250|NCT00650767|Secondary|Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])|The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762251|NCT00650767|Secondary|Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])|The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762252|NCT00650767|Secondary|Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])|The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762253|NCT00650767|Secondary|Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])|The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762254|NCT00650767|Secondary|Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])|The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.|Week 2|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762255|NCT00650767|Secondary|Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])|The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.|Week 1|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762256|NCT00650767|Secondary|Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])|The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.|Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762257|NCT00650767|Secondary|C-Reactive Protein (CRP) at Week 16 (Follow-up)||Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||mg/dL||Standard Deviation|Mean
762258|NCT00650767|Secondary|C-Reactive Protein (CRP) at Week 12||Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||mg/dL||Standard Deviation|Mean
762259|NCT00650767|Secondary|C-Reactive Protein (CRP) at Week 8||Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||mg/dL||Standard Deviation|Mean
762260|NCT00650767|Secondary|C-Reactive Protein (CRP) at Week 4||Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||mg/dL||Standard Deviation|Mean
762261|NCT00650767|Secondary|C-Reactive Protein (CRP) at Week 2||Week 2|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||mg/dL||Standard Deviation|Mean
762262|NCT00650767|Secondary|C-Reactive Protein (CRP) at Week 1||Week 1|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||mg/dL||Standard Deviation|Mean
762263|NCT00650767|Secondary|C-Reactive Protein (CRP) at Baseline||Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||mg/dL||Standard Deviation|Mean
762264|NCT00650767|Secondary|Health Assessment Questionnaire – Disability Index (HAQ-DI)|"The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to “without difficulty,” 1 equal to “with some difficulty,” 2 equal to “with much difficulty” and 3 equal to “unable to do.” Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status.
The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability."|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762265|NCT00650767|Secondary|Health Assessment Questionnaire – Disability Index (HAQ-DI)|"The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to “without difficulty,” 1 equal to “with some difficulty,” 2 equal to “with much difficulty” and 3 equal to “unable to do.” Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status.
The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability."|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762266|NCT00650767|Secondary|Health Assessment Questionnaire – Disability Index (HAQ-DI)|"The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to “without difficulty,” 1 equal to “with some difficulty,” 2 equal to “with much difficulty” and 3 equal to “unable to do.” Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status.
The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability."|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762267|NCT00650767|Secondary|Health Assessment Questionnaire – Disability Index (HAQ-DI)|"The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to “without difficulty,” 1 equal to “with some difficulty,” 2 equal to “with much difficulty” and 3 equal to “unable to do.” Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status.
The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability."|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762268|NCT00650767|Secondary|Health Assessment Questionnaire – Disability Index (HAQ-DI)|"The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to “without difficulty,” 1 equal to “with some difficulty,” 2 equal to “with much difficulty” and 3 equal to “unable to do.” Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status.
The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability."|Week 2|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762269|NCT00650767|Secondary|Health Assessment Questionnaire – Disability Index (HAQ-DI)|"The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to “without difficulty,” 1 equal to “with some difficulty,” 2 equal to “with much difficulty” and 3 equal to “unable to do.” Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status.
The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability."|Week 1|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762270|NCT00650767|Secondary|Health Assessment Questionnaire – Disability Index (HAQ-DI)|"The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to without difficulty, 1 equal to with some difficulty, 2 equal to with much difficulty and 3 equal to unable to do. Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status.
The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability."|Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762271|NCT00650767|Secondary|Physician’s Global Assessment of Arthritis - Visual Analog Score (VAS)|"The Physician’s Global Assessment of Arthritis was an evaluation based on the patient’s disease signs, functional capacity and physical examination, and was independent of the Patient’s Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS).
The physician’s response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad)."|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762272|NCT00650767|Secondary|Physician’s Global Assessment of Arthritis - Visual Analog Score (VAS)|"The Physician’s Global Assessment of Arthritis was an evaluation based on the patient’s disease signs, functional capacity and physical examination, and was independent of the Patient’s Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS).
The physician’s response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad)."|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762273|NCT00650767|Secondary|Physician’s Global Assessment of Arthritis - Visual Analog Score (VAS)|"The Physician’s Global Assessment of Arthritis was an evaluation based on the patient’s disease signs, functional capacity and physical examination, and was independent of the Patient’s Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS).
The physician’s response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad)."|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762274|NCT00650767|Secondary|Physician’s Global Assessment of Arthritis - Visual Analog Score (VAS)|"The Physician’s Global Assessment of Arthritis was an evaluation based on the patient’s disease signs, functional capacity and physical examination, and was independent of the Patient’s Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS).
The physician’s response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad)."|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762275|NCT00650767|Secondary|Physician’s Global Assessment of Arthritis - Visual Analog Score (VAS)|"The Physician’s Global Assessment of Arthritis was an evaluation based on the patient’s disease signs, functional capacity and physical examination, and was independent of the Patient’s Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS).
The physician’s response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad)."|Week 2|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762276|NCT00650767|Secondary|Physician's Global Assessment of Arthritis - Visual Analog Score (VAS)|"The Physician’s Global Assessment of Arthritis was an evaluation based on the patient’s disease signs, functional capacity and physical examination, and was independent of the Patient’s Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS).
The physician’s response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad)."|Week 1|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762277|NCT00650767|Secondary|Physician's Global Assessment of Arthritis - Visual Analog Score (VAS)|"The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS).
The physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad)."|Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762278|NCT00650767|Secondary|Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)|"The Patient’s Global Assessment of Arthritis was an evaluation based on the patient’s disease signs, functional capacity and physical examination, and was independent of the Physician’s Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS).
Patients answered the following: “Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing.” The patient’s response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly)."|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762279|NCT00650767|Secondary|Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)|"The Patient’s Global Assessment of Arthritis was an evaluation based on the patient’s disease signs, functional capacity and physical examination, and was independent of the Physician’s Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS).
Patients answered the following: “Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing.” The patient’s response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly)."|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762280|NCT00650767|Secondary|Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)|"The Patient’s Global Assessment of Arthritis was an evaluation based on the patient’s disease signs, functional capacity and physical examination, and was independent of the Physician’s Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS).
Patients answered the following: “Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing.” The patient’s response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly)."|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762281|NCT00650767|Secondary|Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)|"The Patient’s Global Assessment of Arthritis was an evaluation based on the patient’s disease signs, functional capacity and physical examination, and was independent of the Physician’s Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS).
Patients answered the following: “Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing.” The patient’s response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly)."|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762282|NCT00650767|Secondary|Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)|"The Patient’s Global Assessment of Arthritis was an evaluation based on the patient’s disease signs, functional capacity and physical examination, and was independent of the Physician’s Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS).
Patients answered the following: “Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing.” The patient’s response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly)."|Week 2|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762340|NCT00650858|Primary|Incidence of Bacterial Ventriculitis, Meningitis|The incidence of bacterial ventriculitis/meningitis was recorded to determine the safety of intraventricular administration of rt-PA. If 30% or more subjects experienced this event, the study would have been stopped for full DSMB review.|30 days|||Number of participants|||Number
762341|NCT00650858|Secondary|1.) Rate of Clot Size Reduction at Days 4-5 Determined by CT Scans (Stages 1 and 2).||180 days||||||
762283|NCT00650767|Secondary|Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)|"The Patient’s Global Assessment of Arthritis was an evaluation based on the patient’s disease signs, functional capacity and physical examination, and was independent of the Physician’s Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS).
Patients answered the following: “Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing.” The patient’s response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly)."|Week 1|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762284|NCT00650767|Secondary|Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)|"The Patient's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Physician's Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS).
Patients answered the following: Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing. The patient's response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly)."|Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762285|NCT00650767|Secondary|Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)|The Patient’s Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762286|NCT00650767|Secondary|Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)|The Patient’s Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762287|NCT00650767|Secondary|Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)|The Patient’s Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762288|NCT00650767|Secondary|Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)|The Patient’s Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762289|NCT00650767|Secondary|Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)|The Patient’s Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.|Week 2|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762290|NCT00650767|Secondary|Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)|The Patient’s Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.|Week 1|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762291|NCT00650767|Secondary|Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)|The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.|Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762292|NCT00650767|Secondary|American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.
The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling."|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762293|NCT00650767|Secondary|American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.
The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling."|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762294|NCT00650767|Secondary|American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.
The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling."|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762342|NCT00650858|Primary|30-day Mortality|The number of subjects who died at or before the 30-day follow-up visit were determined as a measure of safety. If more than 50% of the subjects died at or before the 30-day follow-up visit, the study would have been stopped for full DSMB review.|30 days|||Number of participants|||Number
762295|NCT00650767|Secondary|American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.
The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling."|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762296|NCT00650767|Secondary|American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.
The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling."|Week 2|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762297|NCT00650767|Secondary|American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.
The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling."|Week 1|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762298|NCT00650767|Secondary|American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.
The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling."|Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762299|NCT00650767|Secondary|American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.
Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness."|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762300|NCT00650767|Secondary|American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.
Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness."|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762301|NCT00650767|Secondary|American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.
Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness."|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762302|NCT00650767|Secondary|American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.
Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness."|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762303|NCT00650767|Secondary|American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.
Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness."|Week 2|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762304|NCT00650767|Secondary|American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.
Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness."|Week 1|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762305|NCT00650767|Secondary|American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.
Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness."|Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
762306|NCT00650767|Secondary|American College of Rheumatology 70% (ACR70) Response Rate at Week 16 (Follow-up)|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.
The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria."|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||percentage of participants||95% Confidence Interval|Number
762307|NCT00650767|Secondary|American College of Rheumatology 70% (ACR70) Response Rate at Week 12|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.
The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria."|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||percentage of participants||95% Confidence Interval|Number
762308|NCT00650767|Secondary|American College of Rheumatology 70% (ACR70) Response Rate at Week 8|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.
The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria."|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||percentage of participants||95% Confidence Interval|Number
762309|NCT00650767|Secondary|American College of Rheumatology 70% (ACR70) Response Rate at Week 4|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.
The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria."|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||percentage of participants||95% Confidence Interval|Number
762310|NCT00650767|Secondary|American College of Rheumatology 70% (ACR70) Response Rate at Week 2|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.
The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria."|Week 2|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||percentage of participants||95% Confidence Interval|Number
762311|NCT00650767|Secondary|American College of Rheumatology 70% (ACR70) Response Rate at Week 1|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.
The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria."|Week 1|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||percentage of participants||95% Confidence Interval|Number
762312|NCT00650767|Secondary|American College of Rheumatology 50% (ACR50) Response Rate at Week 16 (Follow-up)|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.
The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria."|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||percentage of participants||95% Confidence Interval|Number
762313|NCT00650767|Secondary|American College of Rheumatology 50% (ACR50) Response Rate at Week 12|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.
The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria."|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||percentage of participants||95% Confidence Interval|Number
762314|NCT00650767|Secondary|American College of Rheumatology 50% (ACR50) Response Rate at Week 8|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.
The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria."|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||percentage of participants||95% Confidence Interval|Number
762315|NCT00650767|Secondary|American College of Rheumatology 50% (ACR50) Response Rate at Week 4|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.
The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria."|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||percentage of participants||95% Confidence Interval|Number
762343|NCT00651040|Secondary|Assessment of Disease Activity and Damage,Muscle Strength and Endurance, Enzyme Levels, Glucocorticoid Side-effects, Dose, HAQ,SF-36, Treatment Failures||1 year||12/2016||||
764983|NCT00673127|Primary|PSA Response|PSA decline of 50% from baseline confirmed by a PSA at least 4 weeks later.|From treatment initiation until treatment cessation. Maximum 32 months. Median treament duration 8 months.|||percentage of participants||95% Confidence Interval|Number
762316|NCT00650767|Secondary|American College of Rheumatology 50% (ACR50) Response Rate at Week 2|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.
The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria."|Week 2|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||percentage of participants||95% Confidence Interval|Number
762317|NCT00650767|Secondary|American College of Rheumatology 50% (ACR50) Response Rate at Week 1|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.
The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria."|Week 1|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||percentage of participants||95% Confidence Interval|Number
762318|NCT00650767|Secondary|American College of Rheumatology 20% (ACR20) Response Rate at Week 16 (Follow-up)|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.
The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria."|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||percentage of participants||95% Confidence Interval|Number
762319|NCT00650767|Secondary|American College of Rheumatology 20% (ACR20) Response Rate at Week 8|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.
The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria."|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||percentage of participants||95% Confidence Interval|Number
762320|NCT00650767|Secondary|American College of Rheumatology 20% (ACR20) Response Rate at Week 4|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.
The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria."|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||percentage of participants||95% Confidence Interval|Number
762321|NCT00650767|Secondary|American College of Rheumatology 20% (ACR20) Response Rate at Week 2|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.
The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria."|Week 2|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||percentage of participants||95% Confidence Interval|Number
762322|NCT00650767|Secondary|American College of Rheumatology 20% (ACR20) Response Rate at Week 1|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.
The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria."|Week 1|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||percentage of participants||95% Confidence Interval|Number
762323|NCT00650767|Primary|American College of Rheumatology 20% (ACR20) Response Rate at Week 12|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.
The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria."|Week 12|Analysis group is comprised of the Intent-to-Treat (ITT) population, which is all patients who were randomized to a treatment group.||percentage of participants||95% Confidence Interval|Number
762324|NCT00650806|Secondary|Change in Waist/Hip Ratio From Baseline to Week 12|The table below shows the mean change in waist/hip ratio from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the least-squares mean change.|Day 1 (Baseline) and Week 12|This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when the Week 12 values were missing. The table includes only patients with both baseline and post baseline values.||ratio||Standard Deviation|Mean
762325|NCT00650806|Secondary|Change in Hip Circumference From Baseline to Week 12|The table below shows the mean change in hip circumference from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the least-squares mean change.|Day 1 (Baseline) and Week 12|This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when the Week 12 values were missing. The table includes only patients with both baseline and post baseline values.||cm||Standard Deviation|Mean
762344|NCT00651040|Primary|The Primary Endpoint is the Total Dose of Glucocorticoids Administered Between Baseline and the End of Treatment.|The primary endpoint which has benn measured was the total dose of glucocorticoids administered between baseline and the end of treatment.|1 year|||mg/kg||Standard Deviation|Mean
764984|NCT00673153|Secondary|Number of Participants Alive at Day 30 (Good-risk Group)||At day 30|Good-risk Group: aged 60-69 years with performance status 0-3, or aged ≥70 years and performance status 0-1||Participants|||Count of Participants
762326|NCT00650806|Secondary|Change in Waist Circumference From Baseline to Week 12|The table below shows the mean change in waist circumference from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the least-squares mean change.|Day 1 (Baseline) and Week 12|This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when the Week 12 values were missing. The table includes only patients with both baseline and post baseline values.||cm||Standard Deviation|Mean
762327|NCT00650806|Secondary|Percentage of Patients Who Lost at Least 10% of Their Initial Body Weight by Week 12|The table below shows the percentage of patients who lost at least 10% of their initial body weight by Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo).|Day 1 (Baseline) and Week 12|This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when the Week 12 values were missing. The table includes only patients with both baseline and post baseline values.||Percentage of patients|||Number
762328|NCT00650806|Secondary|Percentage of Patients Who Lost at Least 5% of Their Initial Body Weight by Week 12|The table below shows the percentage of patients who lost at least 5% of their initial body weight by Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo).|Day 1 (Baseline) and Week 12|This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when the Week 12 values were missing. The table includes only patients with both baseline and post baseline values.||Percentage of patients|||Number
762329|NCT00650806|Secondary|Change in Body Mass Index (BMI) From Baseline to Week 12|The table below shows the mean change in BMI from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the least-squares mean change.|Day 1 (Baseline) and Week 12|This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when the Week 12 values were missing. The table includes only patients with both baseline and post baseline values.||kg/m2||Standard Deviation|Mean
762330|NCT00650806|Secondary|Absolute Change in Body Weight From Baseline to Week 12|The table below shows the mean absolute change in body weight from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the least-squares mean change.|Day 1 (Baseline) and Week 12|This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when the Week 12 values were missing. The table includes only patients with both baseline and post baseline values.||kg||Standard Deviation|Mean
762331|NCT00650806|Primary|Percent Change in Body Weight From Baseline to Week 12|The table below shows the mean percent change in body weight from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the least-squares mean percent change.|Day 1 (Baseline) and Week 12|This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when the Week 12 values were missing. The table includes only patients with both baseline and post baseline values.||Percent change||Standard Deviation|Mean
762332|NCT00650845|Secondary|eGFR Values Variation Between Baseline and 72±24 Hours After Examination, in the Per Protocol Population|eGFR (estimated Glomerular Filtration Rate) was assessed using creatinemia and the Modification of Diet in Renal Disease (MDRD) study equation. eGFR were evaluated in terms of mean difference between the pre- and post-MRI procedure. The eGFR variation was expressed as a percentage of change from baseline values.|Baseline pre MRI and 3 days post MRI|Per protocol population: This population is comprised of the full analysis set population (i.e. all included patients with a pre and a post- procedure blood sample for creatinine measurements) deprived of patients with protocol deviations/violations.||Percentage of change from baseline||Standard Deviation|Mean
762333|NCT00650845|Secondary|Percent Change of Estimated Glomerular Filtration Rate (eGFR) Values From Baseline to 72±24 Hours After Examination, in the Full Analysis Set Population|eGFR was assessed using creatinemia and the Modification of Diet in Renal Disease (MDRD) study equation. eGFR were evaluated in terms of mean difference between the pre- and post-MRI procedure. The eGFR variation was expressed as a percentage of change from baseline values.|Baseline pre MRI and 3 days post MRI|Full analysis set population: all included patients with a pre and a post-procedure blood sample for creatinine measurements.||Percentage of change from baseline||Standard Deviation|Mean
762334|NCT00650845|Secondary|Percent Change of Serum Creatinine Level Variation From Baseline to 72±24 Hours After Examination, in the Per Protocol Population|Serum creatinine levels were measured at baseline and at 72±24 hours after examination. The percentage of change in creatinemia from baseline was calculated for both the Dotarem® and the non-enhanced groups.|Baseline pre MRI and 3 days post MRI|Per protocol population. This population is comprised of the full analysis set population (i.e. all included patients with a pre and post-procedure blood sample for creatinine measurement) deprived of patients with protocol deviations/violations.||Percentage of change from baseline||Standard Deviation|Mean
762335|NCT00650845|Primary|Number of Patients Presenting Contrast-induced Nephropathy as Defined by an Increase in Serum Creatinine Levels of at Least 25% Over Baseline Levels, in the Per Protocol Population.|Comparing the number of patients experiencing an increase of creatinine of at least 25% over baseline levels after Dotarem®-enhanced MRI and after non-enhanced MRI in patients with at least a moderate renal insufficiency.|Baseline pre MRI and 3 days post MRI|Per protocol population: This population is comprised of the full analysis set population (i.e. all included patients with a pre and post-procedure blood sample for creatinine measurement) deprived of patients with protocol deviations/violations.||Number of patients|||Number
762441|NCT00652340|Primary|Time to Disease Progression (TDP)||Baseline and every other cycle.|A 1-sided log rank test was used to achieve 80% power at an α=0.20 significance level to detect a difference of 0.13 between the proportions of patients who are progression free in AP/E (0.34) and P/E (0.21) after 5 months; an overall sample size of 115 patients (77 in AP/E and 38 in P/E) will be randomized in a 2:1 ratio in this study.||months||95% Confidence Interval|Median
762345|NCT00651118|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)at the End of 14 Days|"adult Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scored at day 1(baseline) and at day 14.
The scale is measured from a value of 0 to 24. A negative number corresponds to a change from baseline measurement.The more negative the value the better the result."|day 1 to day 14|intent to treat( ITT)population (18 yrs of age or older) must have had at least one post baseline efficacy assessment||units on a scale||Standard Deviation|Least Squares Mean
762346|NCT00651118|Secondary|Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (iTNSS)|"change from baseline in 12-hour instantaneous ( how do you feel now) total nasal symptom score (iTNSS)consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary cards for the entire 14 day study period.
The measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value.The more negative the value the better the result."|day 1 to day 14|intent to treat population (ITT)- must have had at least one post baseline efficacy assessment||units on a scale||Standard Deviation|Least Squares Mean
762347|NCT00651118|Primary|Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (rTNSS)|"change from baseline in 12-hour reflective(how did you feel in the last 12 hours) total nasal symptom score (rTNSS)consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary cards for the entire 14 day study period.
The measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value.The more negative value the better the result."|days 1 to 14|intent to treat population (ITT)- must have had at least one post baseline efficacy assessment||units on a scale||Standard Deviation|Least Squares Mean
762348|NCT00651157|Secondary|Time to Disease Progression|Time to disease progression is defined as the time from registration to documentation of disease progression. If a patient dies without documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death.|Time from registration to documentation of disease progression, assessed up to 5 years|||days||95% Confidence Interval|Median
762349|NCT00651157|Secondary|Overall Survival|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.|Time from registration to death due to any cause, assessed up to 5 years|||months||95% Confidence Interval|Median
762350|NCT00651157|Primary|Tumor Response|"A tumor response is defined to be a Complete Response (CR) or Partial Response (PR) as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) noted as the objective status on 2 consecutive evaluations at least 4 weeks apart.
Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the largest dimension (LD) of target lesions taking as reference the baseline sum LD."|Every 4 weeks after 4 courses of treatment, assessed up to 5 years|||participants|||Number
762351|NCT00651183|Primary|Change From Baseline in UPDRS Part III (Motor Examination)|14 components rating scale with 27 items scored by 0 (none) - 4 (severe)|Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score)|Only those patients of the full analysis set (FAS) with an evaluation of UPDRS Part III at visit 3 were included in this analysis||Points on a scale||Inter-Quartile Range|Median
762352|NCT00651183|Primary|Change From Baseline in Hospital Anxiety and Depression Scale - HADS-A Anxiety Subscore|"Anxiety Scale - 7 items scored for each individual question from 0 = best and 3 = worst.
HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression.
It comprises of 14 items, thereof seven statements describe anxiety and seven statements depression. Each answer is rated on a four-point scale (0-3). All seven answers are summarized and calculated to a total score to the anxiety scale and to the depression scale with a maximum score of 21 points for each scale."|Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score)|Only those patients of the full analysis set (FAS) with an evaluation of HADS-A at visit 3 were included in this analysis||Points on a scale||Inter-Quartile Range|Median
762353|NCT00651183|Primary|Change From Baseline in Hospital Anxiety and Depression Scale - HADS-D Depression Subscore|"Depression Scale - 7 items scored for each individual question from 0 = best and 3 = worst.
HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression.
It comprises of 14 items, thereof seven statements describe anxiety and seven statements depression. Each answer is rated on a four-point scale (0-3). All seven answers are summarized and calculated to a total score to the anxiety scale and to the depression scale with a maximum score of 21 points for each scale."|Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score)|Only those patients of the full analysis set (FAS) with an evaluation of HADS-D at visit 3 were included in this analysis||Points on a scale||Inter-Quartile Range|Median
762354|NCT00651183|Primary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part I (Mentation, Behaviour and Mood)|"Rating scale scored from 0 (none) - 4 (severe). The UPDRS Part I (Mentation, Behaviour and Mood during the Past Week) consist of 4 items, each of them is scored from 0 (normal) to 4 (severe). Reduction in this score over time is interpreted as improvement.
Total UPDRS part I score ranges from 0 = best score to 16 = worst score"|Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score)|Only those patients of the full analysis set (FAS) with an evaluation of UPDRS Part I at visit 3 were included in this analysis||Points on a scale||Inter-Quartile Range|Median
762355|NCT00651261|Secondary|DFS Rate One Year After Completing the Planned Continuation Phase||30 months||||||
762356|NCT00651261|Secondary|Disease-free Survival (DFS)|Disease free survival (DFS) is defined as the time from documentation of first CR at any time to the first of relapse or death from any cause in participants who achieved a CR.|Duration of study (Up to 10 years)|||months||95% Confidence Interval|Median
762357|NCT00651261|Secondary|Complete Response Rate|Percentage of participants who achieved a complete response (CR). A CR was defined as normalization of blood counts and a marrow showing less than 5% blasts occurring on or before day 60.|Induction therapy (up to 60 days)|||percentage of participants||95% Confidence Interval|Number
762358|NCT00651261|Secondary|Overall Survival, Censoring Participants Who Receive a Stem Cell Transplant at the Time of the Transplant|Overall survival (OS) was defined as the time interval from randomization to death from any cause. Any participants who received a stem cell transplant were censored at the time of transplant. The median OS with 95% CI was estimated using the Kaplan-Meier method.|Duration of study (Up to 10 years)|||months||95% Confidence Interval|Median
762359|NCT00651261|Secondary|Event- Free Survival|"Event free survival (EFS) was defined as the time from randomization until the earliest qualifying event, including: failure to obtain a CR on or before 60 days of initiation of protocol therapy; relapse; or death from any cause. Patients alive and event free at the time of analysis were censored on the date of last clinical assessment. The median EFS with 95% CI was estimated using the Kaplan-Meier method.
Due to a higher than expected transplant rate, EFS was promoted to be a key secondary endpoint."|Duration of study (Up to 10 years)|||months||95% Confidence Interval|Median
762360|NCT00651261|Primary|Overall Survival (OS)|Overall survival (OS) was defined as the time interval from randomization to death from any cause. The median OS with 95% CI was estimated using the Kaplan-Meier method.|Duration of study (Up to 10 years)|||months||95% Confidence Interval|Median
762361|NCT00651313|Secondary|Evaluate Electrocardiograms (ECGs) for Potentially Significant QT Changes at Approximate Peak Lidocaine Plasma Concentration After 4 Days of Dosing||7 hours following fourth dose in 2 consecutive menstrual cycles||||||
762362|NCT00651313|Primary|Treatment-emgergent Adverse Events||approximately two months, based on onset of menses||||||
762363|NCT00651313|Primary|The Primary Efficacy Variable Will be the Time-weighted Average Pain Intensity Over 4 Treatment Days Using the 4 Point Categorical Scale.||Two 4-day dosing regimens for two consecutive monthy menstrual cycles|Time-weighted average pain intensity over the 4 treatment days using the 4 point categorical scale - none (0), mild (1), moderate (2), and severe (3); primary efficacy variable. ITT Analysis Set.||units on a scale||Standard Deviation|Mean
762364|NCT00651482|Primary|Progression-free Survival (PFS)|Progression-free survival (PFS) per RECIST criteria|24 months|||months||Full Range|Median
762365|NCT00651482|Secondary|Treatment Discontinuation Due to Disease Progression|Number of subjects whose treatment was discontinued due to disease progression|24 months|||participants|||Number
762366|NCT00651482|Secondary|Treatment Discontinuation Due to Toxicity|Number of subjects whose treatment was discontinued due to toxicity|24 months|||participants|||Number
762367|NCT00651482|Secondary|Total Number of Drug-related SAEs||24 months|||events|||Number
762368|NCT00651482|Secondary|Number of Subjects With Drug-related SAEs||24 months|||participants|||Number
762369|NCT00651482|Secondary|Overall Survival (OS)||44 months|||months||Full Range|Median
762370|NCT00651482|Secondary|Time-to-Treatment Failure (TTF)||24 months|||months||Full Range|Median
762371|NCT00651482|Secondary|Objective Response (OR) Duration||24 months|||weeks||Full Range|Median
762372|NCT00651482|Secondary|Objective Response (OR)|Number of subjects with objective response (OR)|24 months|||participants|||Number
762373|NCT00651625|Secondary|Physician Satisfaction|"0- 10 cm visual analogue satisfaction scale (VASS)
0-10 cm VASS at 2 weeks compared to 0-10 cm VASS pain scale at 0 weeks where 0= completely dissatisfied, and 10 = completely satsified. The difference (2 week VAS-0 week VAS) is the outcome measure"|during procedure|||cm||Standard Deviation|Mean
762374|NCT00651625|Secondary|Adverse Outcomes (Hemorrhage, Infection, Hematoma, Extravasation)||during procedure, 2 weeks afterwards, and 6 months afterwards|||participants|||Number
762375|NCT00651625|Secondary|Aspirated Fluid Volume|Aspirated fluid volume during procedure|during procedure|||ml||Standard Deviation|Mean
762376|NCT00651625|Primary|Pain Using VAS (Visual Analogue Pain Scale)|0-10 cm VAS pain scale at 2 weeks compared to 0-10 cm VAS pain scale at 0 weeks where 0= no pain, and 10 = the worst pain imaginable. The difference (2 week VAS-0 week VAS) is the primary outcome measure.|2 weeks|||cm||Standard Deviation|Mean
762377|NCT00651755|Primary|Geometric Mean Area Under Curve (AUC) of Analyte, Prednisolone (PL), in Aprepitant Treatment and Control Group|Pharmacokinetic (PK) blood sampling to determine the geometric mean AUC of PL, during & post chemotherapy infusion, baseline, at 30, 60, 75, 90 minutes, and 2 , 4, 6, 8, and 24 hours from start of cyclophosphamide infusion. The absence of PK drug interactions was determined if the 90% Confidence Intervals (CI) of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25. Measurements reported as concentrate times the time, i.e. nanograms (ng)/milliliters (mL) times hour (hr).|Time points over 8 hours of cyclophosphamide infusion for both cycles (21 day cycle)|Per protocol, 18 participants were eligible for PK analysis.||ng/mL*hr||90% Confidence Interval|Geometric Mean
762378|NCT00651755|Primary|Geometric Mean Area Under Curve (AUC) of Analyte,Prednisone (PR), in Aprepitant Treatment and Control Group|Pharmacokinetic (PK) blood sampling to determine the geometric mean AUC of PR, during & post chemotherapy infusion, baseline, at 30, 60, 75, 90 minutes, and 2 , 4, 6, 8, and 24 hours from start of cyclophosphamide infusion. The absence of PK drug interactions was determined if the 90% Confidence Intervals (CI) of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25. Measurements reported as concentrate times the time, i.e. nanograms (ng)/milliliters (mL) times hour (hr).|Time points over 8 hours of cyclophosphamide infusion for both cycles (21 day cycle)|Per protocol, 18 participants were eligible for PK analysis.||ng/mL*hr||90% Confidence Interval|Geometric Mean
762379|NCT00651755|Primary|Geometric Mean Area Under Curve (AUC) of Analyte, Vincristine (VC), in Aprepitant Treatment and Control Group|Pharmacokinetic (PK) blood sampling to determine the geometric mean AUC of VC, during & post chemotherapy infusion, baseline, at 30, 60, 75, 90 minutes, and 2 , 4, 6, 8, and 24 hours from start of cyclophosphamide infusion. The absence of PK drug interactions was determined if the 90% Confidence Intervals (CI) of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25. Measurements reported as concentrate times the time, i.e. nanograms (ng)/milliliters (mL) times hour (hr).|Time points over 24 hours of cyclophosphamide infusion for both cycles (21 day cycle)|There were 18 patients eligible for PK analysis, two participants were excluded from the analysis due to data issues.||ng/mL*hr||90% Confidence Interval|Geometric Mean
762380|NCT00651755|Primary|Geometric Mean Area Under Curve (AUC) of Analyte, 4-hydroxy-cyclophosphamide (4-OH-CP), in Aprepitant Treatment and Control Group|Pharmacokinetic (PK) blood sampling to determine the geometric mean AUC of 4-hydroxy-cyclophosphamide (4-OH-CP), during & post chemotherapy infusion, baseline, at 30, 60, 75, 90 minutes, and 2 , 4, 6, 8, and 24 hours from start of cyclophosphamide infusion. The absence of PK drug interactions was determined if the 90% Confidence Intervals (CI) of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25. Measurements reported as concentrate times the time, i.e. micrograms (ug)/milliliters (mL) times hour (hr).|Time points over 24 hours of cyclophosphamide infusion for both cycles (21 day cycle)|There were 18 participants eligible for PK analysis, one was excluded from the final analysis due to data issues.||ug/mL*hr||90% Confidence Interval|Geometric Mean
762381|NCT00651755|Primary|Geometric Mean Area Under Curve (AUC) of Analyte, 2-dechloro-cyclophosphamide(2-deCI-CP), in Aprepitant Treatment and Control Group|Pharmacokinetic (PK) blood sampling to determine the geometric mean AUC of 2-deCI-CP, during & post chemotherapy infusion, baseline, at 30, 60, 75, 90 minutes, and 2 , 4, 6, 8, and 24 hours from start of cyclophosphamide infusion. The absence of PK drug interactions was determined if the 90% Confidence Intervals (CI) of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25. Measurements reported as concentrate times the time, i.e. micrograms (ug)/milliliters (mL) times hour (hr).|Time points over 24 hours of cyclophosphamide infusion for both cycles (21 day cycle)|There were 18 participants eligible for PK analysis, one was excluded from the final analysis due to data issues.||ug/mL*hr||90% Confidence Interval|Geometric Mean
762382|NCT00651755|Primary|Geometric Mean Area Under Curve (AUC) of Analyte, Cyclophosphamide (CP), in Aprepitant Treatment and Control Group|Pharmacokinetic (PK) blood sampling to determine the geometric mean AUC of Cyclophosphamide (CP) during & post chemotherapy infusion, baseline, at 30, 60, 75, 90 minutes, and 2 , 4, 6, 8, and 24 hours from start of cyclophosphamide infusion. The absence of PK drug interactions was determined if the 90% Confidence Intervals (CI) of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25. Measurements reported as concentrate times the time, i.e. micrograms (ug)/milliliters (mL) times hour (hr).|Time points over 24 hours of cyclophosphamide infusion for both cycles (21 day cycle)|There were 18 participants eligible for PK analysis, one was excluded from the final analysis due to data issues.||ug/mL*hr||90% Confidence Interval|Geometric Mean
762383|NCT00645333|Primary|Maximum Tolerated Dose (MTD)|The Maximum Tolerated Dose (MTD) for MK-0752 will be determined. Dose levels were: Level 1: 300 mg MK-0752 by mouth days 1-3; Level 2: 450 mg MK-0752 by mouth days 1-3; Level 3: 600 mg MK-0752 by mouth days 1-3; Level 4: 800 mg MK-0752 by mouth days 1-3.|Up to 3 years|||mg|||Number
762384|NCT00645333|Primary|Dose Limiting Toxicity (DLT)|"The number of DLTs experienced by participants within the first 21 days.
DLTs were defined as toxicities possibly, probably, or definitely related to the study drug observed during the first 2 cycles (first 42 days) as follows:
Non-hematologic toxicity Grade ≥3 by the NCI CTCAE version 3.0.
ANC<1000 for more than 7 days despite use of pegfilgrastim.
Platelet count <25,000 for more than 7 days, or associated with bleeding, or less than 10,000 at any time."|first 21 days|||Dose Limiting Toxicities|||Number
762385|NCT00645359|Primary|The Odds Ratio (OR) Between Tumor Response (Based on Changes in MR Imaging) and Duration of Response|To correlate the changes on MR images with the tumor response after completion of chemotherapy and duration of response. Tumor response will be determined by the clinical evaluation, tumor dimensions, and metabolic response as assessed by 18-Fluoro-deoxy.|2 years|No patients were analyzed due to insufficient resources, secondary to shifting research priorities.|||||
762386|NCT00645359|Primary|Mean Difference in Apparent Diffusion Coefficient|To assess whether changes in the apparent diffusion coefficient (ADC) during the early phase of chemotherapy are detectable in lymphoma, the ADC value will be calculated at the voxel level, on baseline and Day 8, and the mean difference will be calculated.|Baseline and Day 8|No patients were analyzed due to insufficient resources, secondary to shifting research priorities.|||||
762387|NCT00645411|Secondary|Number of Subjects Reporting Local and Systemic Reactions After One and Two Doses of the Cell Culture-derived Vaccine or Egg-derived Influenza Vaccine in 3 to 8 Year-old Children.|To evaluate the safety and tolerability of the cTIV and the eTIV influenza vaccines in 3 to 8 year-old children terms of number of participants reporting local and systemic reactions after each vaccination.|up to 7 days after each vaccination|The analysis was performed on the safety dataset set.||Subjects|||Number
762388|NCT00645411|Secondary|Number of Subjects Reporting Local and Systemic Reactions After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents.|To evaluate safety and tolerability in terms of number of 9 to 17 year-old children and adolescents (cohorts 1 and 2) reporting local and systemic reactions following of one injection of the cTIV or the eTIV vaccine .|up to 7 days after vaccination|The analysis was performed on the safety dataset||Subjects|||Number
762389|NCT00645411|Secondary|Percentages of Subjects Who Achieved Seroconversion or Significant Increase in HI Titers After Two Doses of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 3 to 8 Year-old Children|"Seroconversion or significant increase as per CHMP criteria is defined as percentage of subjects with a pre vaccination HI titer <10 to a post vaccination titer ≥40 or a pre vaccination HI titer ≥10 and a ≥4-fold increase in post vaccination HI antibody titer. According to the CHMP criteria, the percentage of subjects achieving seroconversion or significant increase should be >40%.
According to the CBER criteria, the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion/significant increase should be ≥40%."|Day 29 and Day 50 post vaccination|The analysis was performed on the per-protocol dataset.||Percentages of subjects||95% Confidence Interval|Number
762390|NCT00645411|Secondary|Percentages of Subjects Who Achieved HI Titers ≥40 After Two Doses of the Cell Culture Derived or the Egg Derived Influenza Vaccine in 3 to 8 Year-old Children|"To evaluate immunogenicity in terms of HI titers ≥40, in children 3-8 years of age after two doses of either cTIV vaccine or eTIV vaccine, administered 4 weeks apart.
The criterion is met according to European (CHMP) guideline if the percentage of subjects achieving HI titers ≥40 is >70% and according to the US (CBER) guideline if the lower bound of the two sided 95%CI for percentage of subjects achieving HI titers ≥40 is ≥70%."|Day 29 and Day 50 post vaccination|The analysis was performed on the per-protocol dataset.||Percentages of subjects||95% Confidence Interval|Number
762391|NCT00645411|Secondary|Geometric Mean Ratio After Two Doses of the Cell-derived or the Egg-derived Vaccine in 3 to 8 Year-old Children|"To evaluate immunogenicity in terms of Geometric Mean Ratio (GMR) in children 3 to 8 years of age after two doses of either the cTIV vaccine or the eTIV vaccine, administered 4 weeks apart according to the CHMP criteria.
The criterion is met according to the European (CHMP) guideline if the mean geometric increase (GMR day 29/day 1 and GMR day 50/day 1) in HI antibody titer is >2.5"|Day 29 and Day 50 post vaccination|The analysis was performed on the per-protocol dataset.||Ratio||95% Confidence Interval|Geometric Mean
762392|NCT00645411|Secondary|Geometric Mean Titers After Two Doses of the Cell Derived or the Egg Derived Vaccine in 3 to 8 Year-old Children|To evaluate immunogenicity in terms of Geometric Mean Titers (GMTs) in children 3 to 8 years of age after two doses of either cTIV vaccine or eTIV,administered 4 weeks apart.|Day 29 and Day 50 post vaccination|The analysis was performed on the per-protocol dataset.||Titers||95% Confidence Interval|Geometric Mean
762393|NCT00645411|Secondary|Percentages of Subjects Who Attained Seroconversion or Significant Increase After 1 Dose of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents|"Seroconversion or significant increase as per CHMP criteria is defined as percentage of subjects with a pre vaccination HI titer <10 to a post vaccination titer ≥40 or a pre vaccination HI titer ≥10 and a ≥4-fold increase in post vaccination HI antibody titer. According to the CHMP criteria, the percentage of subjects achieving seroconversion or significant increase should be >40%.
According to the CBER criteria, the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion/significant increase should be ≥40%."|Day 29 post vaccination|The analysis was performed on the per-protocol dataset.||Percentages of subjects||95% Confidence Interval|Number
762394|NCT00645411|Secondary|Percentages of Subjects Who Achieved HI Titers ≥40 After 1 Dose of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents|"To evaluate immunogenicity in terms of percentage of 9 to 17 year-old children and adolescents achieving HI titers ≥40, after one injection of either the cTIV vaccine or the eTIV vaccine.
This criterion is met according to European (CHMP) guideline if the percentage of subjects achieving HI titers ≥40 is >70% and according to the US (CBER) guideline is met if the lower bound of the two sided 95%CI for percentage of subjects achieving HI titers ≥40 is ≥70%."|Day 29 post vaccination|The analysis was performed on the per-protocol dataset.||Percentages of subjects||95% Confidence Interval|Number
762395|NCT00645411|Secondary|Geometric Mean Ratio After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents.|"Immunogenicity was evaluated in terms of Geometric Mean Ratio (GMRs) in 9 to 17 year-old children and adolescents after one injection of either cTIV vaccine or eTIV.
The criterion is met according to European (CHMP) guideline if the mean geometric increase GMR (day29/day1) in HI antibody titer is >2.5."|Day 29 post vaccination|The analysis was performed on the per-protocol dataset.||Ratio||95% Confidence Interval|Geometric Mean
762396|NCT00645411|Secondary|Geometric Mean Titers After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents|"To evaluate immunogenicity in terms of Geometric Mean Titers (GMTs) in children 9 to 17 years of age after one injection of either cTIV vaccine or eTIV.
GMTs were evaluated using two assays, HI egg derived antigen assay and HI cell derived antigen assay."|Day 29 post vaccination|The analysis was performed on the per-protocol dataset.||Titers||95% Confidence Interval|Geometric Mean
762397|NCT00645411|Primary|Percentages of Subjects Who Attained Seroconversion or Significant Increase in Antibody Titers in the Cell Culture-derived Vaccine Compared With the Egg-derived Vaccine in 3 to 8 Year-old Children|"To demonstrate non-inferiority of the cell culture-derived influenza (cTIV) vaccine to the egg-derived (eTIV) influenza vaccine in the percentage of subjects achieving seroconversion or significant increase in antibody titer post vaccination, for all three strains, after two injections administered four weeks apart in children 3 to 8 years of age.
Seroconversion rate was evaluated using two assays- HI egg derived antigen assay and HI cell derived antigen assay."|Day 50 post vaccination|The analysis was performed on the per-protocol dataset||Percentages of subjects||95% Confidence Interval|Number
762398|NCT00645411|Primary|Geometric Mean Titers of the Cell Culture-derived Vaccine Compared With the Egg-derived Vaccine in 3 to 8 Year-old Children|"To demonstrate non-inferiority of the post vaccination hemagglutination inhibition (HI) geometric mean titer (GMT) of the cell culture-derived influenza (cTIV) vaccine to the corresponding GMT of the egg-derived (eTIV) influenza vaccine, for all three strains, after two injections administered four weeks apart to a subset of children 3 to 8 years of age.
GMTs were evaluated using two assays, HI egg derived antigen assay and HI cell derived antigen assay."|Day 50 post vaccination|The analysis was performed on the per-protocol dataset||Titers||95% Confidence Interval|Geometric Mean
762399|NCT00645528|Primary|Barriers to Insulin Treatment Total Sum Score Visit 2 (Week 2)|"The Barriers to Insulin Treatment Questionnaire (BIT) was completed at the start of the first visit and at the end of the second visit. The BIT is a 14 item self-administered questionnaire with 5 subscales, each representing a different psychological barrier to insulin treatment. Scales are scored 1-10, representing the mean answer of the 10-point Likert questions for the relevant scale. The higher the score, the greater the barriers to insulin treatment, with the exception of the 2nd scale (Expectations regarding positive insulin-related outcomes) where the lower the score, the greater the barriers to insulin treatment. An overall sum score is calculated the same way, after inverting the items of the 2nd scale. The overall sum scale is scored 1-10, representing the mean answers of the 10-point Likert questions. The higher the score, the greater the barriers to insulin treatment. The Total Sum Score and each subscale at Visit 2 is reported here."|Visit 2 (week 2)|||units on a scale||Standard Deviation|Mean
762400|NCT00645528|Primary|Barriers to Insulin Treatment Total Sum Score Visit 1 (Week 0)|"The Barriers to Insulin Treatment Questionnaire (BIT) was completed at the start of the first visit and at the end of the second visit. The BIT is a 14 item self-administered questionnaire with 5 subscales, each representing a different psychological barrier to insulin treatment. Scales are scored 1-10, representing the mean answer of the 10 point Likert questions for the relevant scale. The higher the score, the greater the barriers to insulin treatment, with the exception of the 2nd scale (Expectations regarding positive insulin-related outcomes) where the lower the score, the greater the barriers to insulin treatment. An overall sum score can be calculated the same way, after inverting the items of the 2nd scale. The overall sum scale is scored 1-10, representing the mean answers of the 10-point Likert questions. The higher the score, the greater the barriers to insulin treatment. The Total Sum Score and each subscale at Visit 1 is reported here."|Visit 1 (week 0)|||units on a scale||Standard Deviation|Mean
762401|NCT00645528|Secondary|Number of Patients Experiencing a Severe Hypoglycemic Event|Severe hypoglycemia is defined as requiring the help of another person to treat the hypoglycemia|2 weeks|||participants|||Number
762402|NCT00645528|Secondary|Number of Subjects Experiencing Hypoglycemic Symptoms|Number of subjects who reported subjective symptoms of hypoglycemia in the two weeks between study visits|2 weeks|As below, 15 subjects reported subjective symptoms of hypoglycemia in the two weeks between study visits; 10 of these subjects had at least one recorded blood glucose value less than 70 mg/dl; Eight of these 10 subjects had started insulin.||participants|||Number
762403|NCT00645528|Secondary|Percent of Patients Who Begin Insulin||2 weeks|||percentage of participants|||Number
767741|NCT00697593|Primary|Hematology - Eosinophils|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 3 participants missing values||x10^9/L||Standard Deviation|Mean
762404|NCT00645528|Primary|"Change in Barriers to Insulin Treatment (BIT) Score From Before to After the Classes"|"The Barriers to Insulin Treatment Questionnaire (BIT) was completed at the start of the first visit and at the end of the second visit. The BIT is a 14 item self-administered questionnaire with 5 subscales, each representing a different psychological barrier to insulin treatment. Scales are scored 1-10, representing the mean answer of the 10-point Likert questions for the relevant scale. The higher the score, the greater the barriers to insulin treatment, with the exception of the 2nd scale (Expectations regarding positive insulin-related outcomes) where the lower the score, the greater the barriers to insulin treatment. An overall sum score is calculated the same way, after inverting the items of the 2nd scale. The overall sum scale is scored 1-10, representing the mean answers of the 10-point Likert questions. The higher the score, the greater the barriers to insulin treatment. Reported here is the change in BIT score from baseline. This was assessed by paired t-test."|2 weeks|32 subjects completed the study||units on a scale||Standard Deviation|Mean
762405|NCT00645567|Primary|Shoulder Force|measurement of applied shoulder force during wheelchair transfers|None reported - verifiable data is not available for any of the participants|As of the November 2012 update to the IRB, there were no findings at that point. At this time, verifiable data is not available for any of the participants.|||||
762406|NCT00645593|Secondary|Median Overall Survival in Months|Median overall survival in months is provided. One participant who progressed from chemotherapy in arm 1 received cyclophosphamide and achieved long-term disease control therefore there is no upper limit for the 95% confidence interval.|3 years|29 patients were enrolled and randomized to arm 1 and 60 patients were enrolled and randomized to arm 2. 1 patient from arm 1 was found to be ineligible and 3 patients from arm 2 withdrew consent (1 prior to treatment and 2 prior to 4 weeks of treatment). Only 28 patients from arm 1 and 57 patients from arm 2 were analyzed.||Months||95% Confidence Interval|Median
762407|NCT00645593|Secondary|Median Progression-free Survival Time in Months|Progressive disease is defined as at least a 20% increase in the sum of the longest diameter of target lesions.|3 years|29 patients were enrolled and randomized to arm 1 and 60 patients were enrolled and randomized to arm 2. 1 patient from arm 1 was found to be ineligible and 3 patients from arm 2 withdrew consent (1 prior to treatment and 2 prior to 4 weeks of treatment). Only 28 patients from arm 1 and 57 patients from arm 2 were analyzed.||months||95% Confidence Interval|Median
762408|NCT00645593|Secondary|The Number of Grade 3 to 5 Adverse Events Experienced by Arm 1 and Arm 2|"One of the secondary outcomes was to assess the safety and tolerability of treatment for both arms.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 were utilized for adverse event reporting."|3 years|Although 60 participants were enrolled and randomized to arm 2, 1 participant withdrew consent prior to treatment and was therefore excluded from toxicity analysis.||adverse events|||Number
762409|NCT00645593|Primary|Percentage of Participants That Respond to Treatment in Arm 1 and Arm 2|"The primary objective is to compare the overall response rate of participants with locally advanced or metastatic urothelial carcinoma treated with gemcitabine and cisplatin with or without cetuximab.
Overall response rate is defined as the percentage of participants that experience Complete Response (CR) (Disappearance of all target lesions) or Partial Response (PR) (>=30% decrease in the sum of the longest diameter of target lesions)."|3 years|29 patients were enrolled and randomized to arm 1 and 60 patients were enrolled and randomized to arm 2. 1 patient from arm 1 was found to be ineligible and 3 patients from arm 2 withdrew consent (1 prior to treatment and 2 prior to 4 weeks of treatment). Only 28 patients from arm 1 and 57 patients from arm 2 were analyzed.||percentage of participants||95% Confidence Interval|Number
762410|NCT00651820|Secondary|Differences in Scar Viscoelasticity Between Wounds Treated With Collagenase Santyl and Its Vehicle|Differences in Scar Viscoelasticity between wounds treated with Collagenase Santyl and its vehicle as measured by Stiffness and Energy Absorption using BTC-2000 measurements.|9 Months|Analysis performed on Intent-to-Treat (ITT) population||mmHg/mm|Participants|Standard Deviation|Mean
762411|NCT00651820|Primary|Time to Complete Wound Closure Collagenase Santyl and Vehicle||21 days|Analysis was performed on all subjects as intent-to-treat (ITT).||Days|Participants|95% Confidence Interval|Mean
762412|NCT00651924|Primary|Comprehension|Each treatment session had 5 True / False questions that corresponded with the material in the patient handbook. Phase 1 participants reviewed individual treatment modules in the patient handbook to provide immediate feedback regarding how understandable, engaging, and informative they find the materials. Phase 2 participants’ used the patient materials as part of treatment and the true/false questions were used to evaluate comprehension of the materials. Example questions: Chronic pain can affect how you feel physically and emotionally (T); Relaxation is the same as being lazy and unproductive (F).|Immediately after review of materials (phase 1); 1 week post review of materials (phase 2)|Per protocol||Percent of questions answered correctly||Standard Deviation|Mean
762413|NCT00652028|Primary|Number of Subjects Who Received Rescue Medication for Sedation (Midazolam) and Analgesics (Fentanyl)|Number of subjects who received rescue medication for Sedation (Midazolam) and analgesics (Fentanyl) while intubated during Treatment Period|During the treatment period (Approximately 24 hours)|Full Evaluable Population: Participants who received study drug infusion for at least 5 hours and had available PK data were included in the full evaluable population. This was the primary population for PK and PD analyses.||participants|||Number
762414|NCT00652028|Primary|Level of Sedation Based on Average Ramsay Sedation Scale (RSS) Score|"RSS Score range from 1 to 6:
Patient is anxious and agitated or restless, or both.
Patient is cooperative, orientated and tranquil.
Patient responds to command only.
Patient exhibits brisk response to light glabellar (between the eyebrows) tap or loud auditory stimulus.
Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus.
Patient exhibits no response to stimulus."|Prior to loading (Baseline), 5 and 10 min during the load, at start of maintenance infusion and every 15 min for 1 hour, hourly during the maintenance period, before and within 5 min after midazolam or fentanyl dose during the dexmedetomidine infusion.|Full Evaluable Population: Participants who received study drug infusion for at least 5 hours and had available PK data were included in the full evaluable population. This was the primary population for PK and PD analyses.||units on a scale||Standard Deviation|Mean
762543|NCT00653224|Secondary|Ocular Pruritus Score Over the First Week|The ocular pruritus score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided.|Over week 1|Number of participants from the ITT population with available ocular pruritus score over Week 1||points on a scale||Standard Deviation|Mean
762415|NCT00652028|Primary|Clearance (CL)|Clearance (CL) for Dexmedetomidine|≤30 min prior to start of loading dose (LD); 5 min before finishing LD; 0.5,1,2 & 4-6 hrs after start of maintenance infusion (MI); 30 min prior to end of MI (within 24 hrs of start of MI); 10 min after end of MI and 0.5,1,2,4 & 10 hrs after end of MI.|Full Evaluable Population: Participants who received study drug infusion for at least 5 hours and had available PK data were included in the full evaluable population. This was the primary population for PK and PD analyses.||Litre/hour||Standard Deviation|Mean
762416|NCT00652028|Primary|Volume of Steady State Distribution (Vss)|Volume of steady state distribution (Vss) for Dexmedetomidine|≤30 min prior to start of loading dose (LD); 5 min before finishing LD; 0.5,1,2 & 4-6 hrs after start of maintenance infusion (MI); 30 min prior to end of MI (within 24 hrs of start of MI); 10 min after end of MI and 0.5,1,2,4 & 10 hrs after end of MI.|Full Evaluable Population: Participants who received study drug infusion for at least 5 hours and had available PK data were included in the full evaluable population. This was the primary population for PK and PD analyses.||Litre||Standard Deviation|Mean
762417|NCT00652028|Primary|Plasma Concentration at Steady State (Css)|Plasma concentration at steady state (Css) for Dexmedetomidine|≤30 min prior to start of loading dose (LD); 5 min before finishing LD; 0.5,1,2 & 4-6 hrs after start of maintenance infusion (MI); 30 min prior to end of MI (within 24 hrs of start of MI); 10 min after end of MI and 0.5,1,2,4 & 10 hrs after end of MI.|Full Evaluable Population: Participants who received study drug infusion for at least 5 hours and had available PK data were included in the full evaluable population. This was the primary population for PK and PD analyses.||picograms per milliliter||Standard Deviation|Mean
762418|NCT00652028|Primary|Terminal Elimination Half-life (t1/2)|Terminal elimination half-life (t1/2) for Dexmedetomidine|≤30 min prior to start of loading dose (LD); 5 min before finishing LD; 0.5,1,2 & 4-6 hrs after start of maintenance infusion (MI); 30 min prior to end of MI (within 24 hrs of start of MI); 10 min after end of MI and 0.5,1,2,4 & 10 hrs after end of MI.|Full Evaluable Population: Participants who received study drug infusion for at least 5 hours and had available PK data were included in the full evaluable population. This was the primary population for PK and PD analyses.||hour||Standard Deviation|Mean
762419|NCT00652028|Primary|Observed Peak Plasma Concentration|Observed peak plasma concentration (Cmax) for Dexmedetomidine|≤30 min prior to start of the loading dose (LD); 5 min before finishing the LD; 0.5,1,2&4 to 6 hrs after start of maintenance infusion (MI); 30 min prior to end of MI (24 hrs of start of MI); 10 min after end of MI and 0.5,1,2,4&10 hrs after end of MI.|Full Evaluable Population: Participants who received study drug infusion for at least 5 hours and had available PK data were included in the full evaluable population. This was the primary population for PK and PD analyses.||picograms per milliliter||Standard Deviation|Mean
762420|NCT00652028|Primary|Area Under the Concentration-time Curve From Time Zero to the Time Infinity (AUC0-∞)|Area under the concentration-time curve from time zero to the time infinity (AUC0-∞) for Dexmedetomidine|≤30 min prior to start of the loading dose (LD); 5 min before finishing the LD; 0.5,1,2&4 to 6 hrs after start of maintenance infusion (MI); 30 min prior to end of MI (24 hrs of start of MI); 10 min after end of MI and 0.5,1,2,4&10 hrs after end of MI.|Full Evaluable Population: Participants who received study drug infusion for at least 5 hours and had available PK data were included in the full evaluable population. This was the primary population for PK and PD analyses.||picograms*hr/mL||Standard Deviation|Mean
762421|NCT00652028|Primary|Area Under the Concentration-time Curve From Time Zero to the Time of the Last Measurable Concentration (AUC0-t)|Area under the concentration-time curve from time zero to the time of the last measurable concentration (AUC0-t) for Dexmedetomidine|≤30 min prior to start of loading dose (LD); 5 min before finishing LD; 0.5,1,2 & 4-6 hrs after start of maintenance infusion (MI); 30 min prior to end of MI (within 24 hrs of start of MI); 10 min after end of MI and 0.5,1,2,4 & 10 hrs after end of MI.|Full Evaluable Population: Participants who received study drug infusion for at least 5 hours and had available PK data were included in the full evaluable population. This was the primary population for pharmacokinetic (PK) and pharmacodynamic (PD) analyses.||picograms*hr/mL||Standard Deviation|Mean
762422|NCT00652093|Secondary|Final Pain|Subjects were instructed to walk on the treadmill and to tell the research coordinator to stop testing when they reached the point at which they typically would need to stop and sit down, or until 15 minutes had elapsed. At defined intervals subjects were asked what their pain level was according to the NRS. When the subject reached their maximum distance, they were asked their NRS score. This was recorded as final pain intensity.|study visit|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.||units on a scale||Standard Deviation|Mean
762423|NCT00652093|Secondary|Swiss Spinal Stenosis Score- Physical Function|The SSS is a series of questions asking about symptom severity, physical function, and satisfaction. The physical function section is a series of 5 questions (maximum 4 points per question) and asks to rate function for each question based on comfortably, sometimes with pain, always with pain, no functional ability. The total score (max=20) is divided by five. The maximum score for the physical function section (max=4) indicates no ability to function.|study visit|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.||units on a scale||Standard Deviation|Mean
762424|NCT00652093|Secondary|Swiss Spinal Stenosis Score- Symptom Severity|The SSS is a series of questions asking about symptom severity, physical function, and satisfaction. The symptom severity section is a set of 7 questions (maximum score is 5 points per question) and asks to rate pain for each question based on no pain, mild, moderate, severe or very severe pain. The total score (maximum=35) is added up and divided by seven. The maximum score for the symptom severity section (score=5) indicates very severe symptom severity.|study visit|||units on a scale||Standard Deviation|Mean
762425|NCT00652093|Secondary|Oswestry Disability Index (ODI) Score|The ODI is a set of 10 questions each with five choices (maximum score of 5 points per question) designed to determine how back pain has affected the ability to manage everyday life (pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social life, traveling, and change positions). A score of 0 indicates no disability and total score of 50 would indicate 100% disability.|study visit|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.||units on a scale||Standard Deviation|Mean
762545|NCT00653224|Secondary|Post-nasal Drip Score Over the Second Week|The post-nasal drip score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided.|Over week 2|Number of participants from the ITT population with available post-nasal drip score over Week 2||points on a scale||Standard Deviation|Mean
762426|NCT00652093|Secondary|Modified Brief Pain Inventory (mBPI)- Interference Score|The mBPI is a series of questions that rates the severity and impact of pain on daily function. The questionnaire is made up of 4 pain severity items using the NRS scale, and seven 11-point pain interference scales (0 indicating no interference and 10 indicating complete interference). For the interference score, a total score of 10 indicates pain completely interferes with activities.|study visit|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.||units on a scale||Standard Deviation|Mean
762427|NCT00652093|Secondary|Roland Morris Disability Questionnaire (RMDQ)|The RMDQ consists of 24 yes/no statements about activity limitations due to back pain. These questions center on movement, ambulation, and self-care activities. Positive (yes) answers each contribute 1 point to cumulative score with total scores ranging from 0 (no disability) to 24 (severely disabled).|study visit|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.||units on a scale||Standard Deviation|Mean
762428|NCT00652093|Secondary|Patient Global Assessment (PGA)|Subjects were asked to rate their low back pain according to the PGA. PGA is the impact of disease activity. PGA was measured on a 5-point scale, where 1=very good, 2=good, 3=fair, 4=poor, and 5=very poor.|study visit|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.||units on a scale||Standard Deviation|Mean
762429|NCT00652093|Secondary|Visual Analog Scale (VAS)|The VAS asked subjects to place a mark indicative of their low back pain during the past day on a 100mm line, with 0mm representing no pain and 100mm representing extreme pain.|study visit|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.||units on a scale||Standard Deviation|Mean
762430|NCT00652093|Secondary|Recovery Time|After the subject completed the treadmill test they were asked to immediately return to the seated position. At this point a timer was started. When the subjects pain level returned to baseline (level of pain subject felt in a seated position before walking) the time was stopped. This was recorded as recovery time. Maximum recovery time is 15 minutes.|study visit|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.||minutes||Standard Deviation|Mean
762431|NCT00652093|Secondary|Total Distance|Subjects were instructed to walk on the treadmill and to tell the research coordinator to stop testing when they reached the point at which they typically would need to stop and sit down, or until 15 minutes had elapsed. When the subject reached their maximum distance, the treadmill testing was stopped. This was recorded as total distance based on number of minutes and seconds walked. Minutes was converted to meters based on calculation of defined speed of the treadmill.|study visit|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.||meters||Standard Deviation|Mean
762432|NCT00652093|Secondary|Area Under the Curve|Subjects were instructed to walk on the treadmill and to tell the research coordinator to stop testing when they reached the point at which they typically would need to stop and sit down, or until 15 minutes had elapsed. At defined intervals (every 30 seconds) subjects were asked what their pain level was according to the NRS. The area under the curve of present pain intensity is the total area combined for the amount of time the subject walked.|study visit|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.||units on a scale * minutes||Standard Deviation|Mean
762433|NCT00652093|Primary|Time to First Symptoms (Tfirst) of Moderate Pain|Using the Numeric Rating Scale (NRS) (0=no pain, 10=worst pain imaginable)the time to first symptoms (Tfirst) with a NRS score greater than or equal to 4 (moderate pain level), with treadmill ambulation was measured. Patients were excluded from the trial if there pain at rest was greater than or equal to 4/10.|study visit|The analyses included all 24 enrolled randomized subjects based on inclusion/exclusion criteria except for three who withdrew from trial prior to completion of study. One dropped out (physician decision) due to an adverse event (AE) (dizzy) and two dropped due to scheduling. This singular AE is not included in the AE reporting below.||minutes||Standard Deviation|Mean
762434|NCT00652314|Secondary|Safety: Immunological Testing for Factor Va Antibodies and Coagulation Parameters||0 day, 30 day, and 60 days post procedure|||participants|||Number
762435|NCT00652314|Secondary|Safety: Incidence Rate of Device-related Adverse Events||Procedure, up to 60 days post procedure|||participants|||Number
762436|NCT00652314|Secondary|Effectiveness: Hemostatic Handling Characteristics (Surgeon’s Questionnaire)|Ease of application to bleeding site as assessed by surgeon questionnaire for hemostatic handling characteristics.|Procedure (application through end of procedure)|Note that the number of participants analyzed (62 and 33) applies to each set of five rows below which apply to the following categories: Ease of application to bleeding site, conformance to tissue surfaces, ease of delivery to hard to reach surfaces, and ease of preparation for use.||participants|||Number
762437|NCT00652314|Secondary|Effectiveness: Device Success (Defined as the Number of Subjects With First Bleeding Site Applications for Which Hemostasis Was Obtained Within 6 Minutes of Study Device Application Without the Need for Adjunctive Treatment)||Procedure, up to 6 minutes post procedure|||participants|||Number
762438|NCT00652314|Primary|The Primary Objective of This Investigation is to Gather Information to Support the Effectiveness of Thrombi-Gel as Compared to a Gelatin Sponge (Gelfoam) Plus Thrombin as an Adjunct to Hemostasis in Multi-specialty Surgical Settings.|Evaluation for hemostasis began immediately following application of the safety product. Hemostasis assessments were to be made every minute for the first 10 minutes post application. If hemostasis was not observed within 10 minutes, the treatment site was to be monitored and the research teams were asked to record the specific number of minutes until hemostasis was observed.|Time to hemostasis (minutes)|||Time to hemostasis (minutes)||Standard Deviation|Mean
762439|NCT00652327|Primary|Percentage Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline at Study Endpoint, After 8 Weeks of Treatment||Assessed at the end of 8 weeks of treatment (from baseline to endpoint)|The population analyzed (intent-to-treat [ITT]) included all participants who had a post-randomization LDL-C laboratory evaluation. As such, 20 of the 83 participants who received treatment assignment were excluded from the ITT. The 5 participants who discontinued were included in the ITT as each had a post-randomization LDL-C lab evaluation.||Percentage change||Standard Deviation|Mean
762440|NCT00652340|Secondary|Overall Survival||Randomization and every cycle|||months||95% Confidence Interval|Median
762442|NCT00652366|Secondary|PFS Assessed From the Start of 4-Week Run-In|PFS assessed from the start of 4-week run-in was defined as the median time, in weeks, from BL to disease progression or death due to any cause. Participants who had neither progressed nor died at time of analysis were censored at the date of last tumor assessment. The 95% CI was determined using Kaplan-Meier methodology.|BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression or death for up to 46 months.|FAS; only participants with an event of PD or death were included in the analysis.||weeks||95% Confidence Interval|Median
762443|NCT00652366|Secondary|Percentage of Participants With Disease Progression or Death as Assessed From the Start of 4-Week Run-In|PFS as assessed from the start of 4-week run-in was defined as the time from BL to the first occurrence of PD according to RECIST or death due to any cause. For TLs, PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, PD was defined as unequivocal progression of existing NTLs. Participants who had neither progressed nor died at time of analysis were censored at the date of last tumor assessment.|BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression or death for up to 46 months.|FAS||percentage of participants|||Number
762444|NCT00652366|Secondary|OS Assessed From Start of 4-Week Run-In|OS assessed from the start of the 4-week run in period was defined as the median time, in months, from BL to the date of death, due to any cause. Participants who were still alive at the time of analysis were censored at the date they were last known to be alive. The 95% CI was determined using Kaplan-Meier methodology.|BL and weekly thereafter for up to 46 months.|FAS||months||95% Confidence Interval|Median
762445|NCT00652366|Secondary|Percentage of Participants Who Died as Assessed From Start of 4-Week Run-In|OS assessed from the start of the 4-week run in period was defined as the time from BL to the date of death due to any cause. Participants still alive at the time of analysis were censored at the date they were last known to be alive.|BL and weekly thereafter for up to 46 months.|FAS||percentage of participants|||Number
762446|NCT00652366|Secondary|Percentage of Participants With SD (Maintained for at Least 8 Weeks) or CR or PR (Maintained for at Least 4 Weeks) According to RECIST|Disease control was defined as a participant with a response of CR or PR for at least 4 weeks at any time during treatment, or SD that was maintained for at least 8 weeks after the start of treatment. The 95% CI for one sample binomial was determined using the Pearson-Clopper method.|BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression for up to 46 months.|FAS||percentage of participants||95% Confidence Interval|Number
762447|NCT00652366|Secondary|Percentage of Participants With a CR, PR, Stable Disease (SD), or PD According to RECIST|CR was defined as the disappearance of all TLs. PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD. PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. The 95% CI for one sample binomial was determined using the Pearson-Clopper method.|BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression for up to 46 months.|FAS||percentage of participants||95% Confidence Interval|Number
762448|NCT00652366|Secondary|Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST|BOR was defined as a confirmed CR or PR for at least 4 weeks. CR was defined as the disappearance of all TLs. PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline (BL) SLD. The 95% CI for one sample binomial was determined using Pearson-Clopper method.|BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression for up to 46 months.|FAS||percentage of participants||95% Confidence Interval|Number
762449|NCT00652366|Secondary|PFS Assessed From Point of Randomization|PFS assessed from the point of randomization was defined as the median time, in weeks, from randomization to disease progression or death due to any cause. Participants who had neither progressed nor died at time of analysis were censored at the date of last tumor assessment. The 95% CI was determined using Kaplan-Meier methodology.|Randomization [Day 1 of Cycle 2 (4-week cycles)] and weekly thereafter for up to 46 months.|FAS||weeks||95% Confidence Interval|Median
762450|NCT00652366|Secondary|Percentage of Participants With Disease Progression or Death as Assessed From Point of Randomization|Progression-free survival (PFS) as assessed from the point of randomization was defined as the time from randomization to the first occurrence of progressive disease (PD) according to the Response Evaluation Criteria in Solid Tumors (RECIST) or death due to any cause. For target lesions (TLs), PD was defined as at least a 20% increase in the sum of longest diameter (SLD) of TLs, taking as reference the smallest SLD recorded since the treatment started. For non-target lesions (NTLs), PD was defined as unequivocal progression of existing NTLs. Participants who had neither progressed nor died at time of analysis were censored at the date of last tumor assessment.|Randomization [Day 1 of Cycle 2 (4-week cycles)] and weekly thereafter for up to 46 months.|FAS||percentage of participants|||Number
762451|NCT00652366|Primary|OS Assessed From Point of Randomization|OS assessed from the point of randomization was defined as the median time, in months, from randomization to the date of death due to any cause. Participants still alive at the time of analysis were censored at the date they were last known to be alive. The 95 percent (%) confidence interval (CI) was determined using Kaplan-Meier methodology.|Randomization [Day 1 of Cycle 2 (4-week cycles)] and weekly thereafter for up to 46 months.|FAS||months||95% Confidence Interval|Median
762452|NCT00652366|Primary|Percentage of Participants Who Died Assessed From Point of Randomization|Overall survival (OS) assessed from the point of randomization was defined as the time from randomization to the date of death due to any cause. Participants still alive at the time of analysis were censored at the date they were last known to be alive.|Randomization [Day 1 of Cycle 2 (4-week cycles)] and weekly thereafter for up to 46 months.|Full analysis set (FAS): all randomized participants.||percentage of participants|||Number
762473|NCT00652899|Secondary|Number of Patients Per Disease Response|Response Evaluation Criteria in Solid Tumors (RECIST) criteria: Complete Response (CR)-Disappearance of all target lesions (TL); Partial Response (PR)-< or = 30% decrease in the sum of the longest diameter (LD) of TL, reference baseline sum LD; Stable Disease (SD)-Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference the smallest sum LD since the treatment started; Progressive Disease (PD)- < or = 20% increase in the sum of the LD of TL, reference the smallest sum LD recorded since treatment started or appearance of < or = 1 new lesion.|1 Month After Natural Killer Cell Infusion (Day 30)|Includes 12 patients that completed treatment per protocol criteria.||Patients|||Number
762453|NCT00652626|Primary|Number of Participants With Adverse Events (AEs)|"A serious adverse event is one that at any dose of the study drug or at any time during the period of observation:
Results in death;
Is life threatening;
Requires inpatient hospitalization or prolongation of existing hospitalization;
Results in persistent or significant disability/incapacity;
Is a congenital anomaly/birth defect;
Is medically important.
The Investigator assessed each AE for potential causal relationship between the event and study drug.
The intensity of adverse changes in physical signs or symptoms was graded from 1 to 5 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3, and according to the following: Mild (Grade 1), Moderate (Grade 2), Severe (Grade 3), Life threatening (Grade 4), or Death (Grade 5)."|Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).|Safety population, all enrolled patients who received at least one dose of azacitidine and who had at least one post-treatment safety assessment.||participants|||Number
762454|NCT00652626|Primary|Apparent Volume of Distribution of Azacitidine (Vz/F) After Single and Multiple Doses of Azacitidine|The apparent volume of distribution of azacitidine after a single dose (Day 1) and multiple doses (Day 5) for participants with normal renal function and severe renal impairment, calculated according to the equation: Vz/F = Apparent total clearance (CL/F) / terminal phase rate constant (λz).|Day 1 and Day 5: predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose|Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants in the 2 treatment groups who received azacitidine treatment for 5 days.||liters||Geometric Coefficient of Variation|Geometric Mean
762455|NCT00652626|Primary|Apparent Total Clearance of Azacitidine (CL/F) After Single and Multiple Doses of Azacitidine|The apparent total clearance of azacitidine after a single dose (Day 1) and multiple doses (Day 5) for participants with normal renal function and severe renal impairment, calculated as Dose/AUC0-inf.|Day 1 and Day 5: predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose|Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants in the 2 treatment groups who received azacitidine treatment for 5 days.||liters/hour||Geometric Coefficient of Variation|Geometric Mean
762456|NCT00652626|Primary|Terminal Phase Half-life of Azacitidine (t½) After Single and Multiple Doses of Azacitidine|The terminal phase half-life of azacitidine after a single dose (Day 1) or multiple doses (Day 5) for participants with normal renal function and severe renal impairment, calculated according to the following equation: t½ = 0.693/λz, where λz is the terminal phase rate constant.|Day 1 and Day 5: predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose|Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants in the 2 treatment groups who received azacitidine treatment for 5 days.||hours||Geometric Coefficient of Variation|Geometric Mean
762457|NCT00652626|Primary|Time to Maximum Plasma Concentration of Azacitidine (Tmax) After Single and Multiple Doses of Azacitidine|The time to first maximum observed plasma concentration of azacitidine after a single dose (Day 1) or multiple doses (Day 5) for participants with normal renal function and severe renal impairment.|Day 1 and Day 5: predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose|Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants in the 2 treatment groups who received azacitidine treatment for 5 days.||hours||Full Range|Median
762458|NCT00652626|Primary|Maximum Plasma Concentration of Azacitidine (Cmax) After Single and Multiple Doses of Azacitidine|The maximum observed plasma concentration of azacitidine after a single dose (Day 1) or multiple doses (Day 5) for participants with normal renal function and for participants with severe renal impairment.|Day 1 and Day 5: predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose|Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants in the 2 treatment groups who received azacitidine treatment for 5 days.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
762459|NCT00652626|Primary|Area Under the Plasma Concentration-time Curve From Time 0 to Infinity After Single and Multiple Doses of Azacitidine|"The area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) for azacitidine, after a single dose (Day 1) and multiple doses (Day 5), calculated by the linear trapezoidal rule and extrapolated to infinity according to the following equation:
AUC0-inf = AUC0-t + (Ct/ke), where Ct is the last quantifiable concentration and ke = elimination rate constant."|Day 1 and Day 5: predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose|Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants in the 2 treatment groups who received azacitidine treatment for 5 days.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
762460|NCT00652626|Primary|Area Under the Plasma Concentration-time Curve From Time 0 to the Last Quantifiable Time Point After Single and Multiple Doses of Azacitidine|The area under the plasma concentration-time curve from time zero to the last quantifiable time point (AUC0-t) of azacitidine following a single dose (Day 1) and multiple doses (Day 5) was calculated by the linear trapezoidal rule for participants with normal renal function and for participants with severe renal impairment.|Day 1 and Day 5: predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose|Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants in the 2 treatment groups who received azacitidine treatment for 5 days.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
762474|NCT00652899|Primary|Number of Patients With In Vivo Expansion of Infused Allogeneic Natural Killer (NK) Cell Product|Detection of an absolute donor derived cell count of > or = 100 cells/mL after NK cell infusion.|Day 12-14|||Patients|||Number
762475|NCT00652938|Secondary|Number of Subjects Reporting Medically Significant Conditions|Medically significant conditions (i.e., AEs prompting emergency room or physician visits that are not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that are not related to common diseases).|Throughout the safety follow-up (month 7 up to Month 12)|Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.||subjects|||Number
762461|NCT00652626|Primary|Area Under the Plasma Concentration-time Curve From Time 0 to 8 Hours Post-dose After Single and Multiple Doses of Azacitidine|"The effect of renal impairment on azacitidine pharmacokinetics was analyzed by comparing PK parameters obtained on Days 1 and 5 from participants with severe renal impairment and those with normal renal function.
Area under the plasma concentration-time curve from time 0 to 8 hours post-dose (AUC0-8) of azacitidine following a single dose (Day 1) and multiple doses (Day 5) was calculated by the linear trapezoidal rule."|Day 1 and Day 5: predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose|Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants in the 2 treatment groups who received azacitidine treatment for 5 days.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
762462|NCT00652626|Primary|Apparent Volume of Distribution of Azacitidine (Vz/F)|The apparent volume of distribution of azacitidine after a single dose on Day 1, calculated according to the equation: Vz/F = Apparent total clearance (CL/F) / terminal phase rate constant (λz)|Day 1 at predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose|Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants with normal renal function only.||liters||Geometric Coefficient of Variation|Geometric Mean
762463|NCT00652626|Primary|Apparent Total Clearance of Azacitidine (CL/F)|The apparent total clearance of azacitidine after a single dose on Day 1, calculated as Dose/AUC0-inf.|Day 1 at predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose|Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants with normal renal function only.||liters/hour||Geometric Coefficient of Variation|Geometric Mean
762464|NCT00652626|Primary|Terminal Phase Half-life of Azacitidine (t½)|The terminal phase half-life of azacitidine after a single dose on Day 1, calculated according to the following equation: t½ = 0.693/λz, where λz is the terminal phase rate constant.|Day 1 at predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose|Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants with normal renal function only.||hours||Geometric Coefficient of Variation|Geometric Mean
762465|NCT00652626|Primary|Time to Maximum Plasma Concentration of Azacitidine (Tmax)|The time to first maximum observed plasma concentration of azacitidine after a single dose on Day 1.|Day 1 at predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose|Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants with normal renal function only.||hours||Full Range|Median
762466|NCT00652626|Primary|Maximum Plasma Concentration of Azacitidine (Cmax)|The maximum observed plasma concentration of azacitidine after a single dose on Day 1.|Day 1 at predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose|Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants with normal renal function only.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
762467|NCT00652626|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity|"The area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) for azacitidine after a single dose, calculated by the linear trapezoidal rule and extrapolated to infinity according to the following equation:
AUC0-inf = AUC0-t + (Ct/ke), where Ct is the last quantifiable concentration and ke = elimination rate constant."|Day 1 at predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose|Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants with normal renal function only.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
762468|NCT00652626|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Time Point|Area under the plasma concentration-time curve from time zero to the last quantifiable time point (AUC0-t) of azacitidine following a single dose of azacitidine on Day 1, calculated by the linear trapezoidal rule.|Day 1 at predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose|Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants with normal renal function only.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
762469|NCT00652626|Primary|Area Under the Plasma Concentration-time Curve From Time 0 to 8 Hours Post-dose|Area under the plasma concentration-time curve from time 0 to 8 hours post-dose (AUC0-8) of azacitidine following a single dose of azacitidine on Day 1, calculated by the linear trapezoidal rule.|Day 1 at predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose|Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants with normal renal function only.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
762470|NCT00652834|Primary|GI Mucosal Lesions Change and Clinical Symptoms Using The Gastrointestinal Symptom Rating Scale (GSRS) Score|"The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms.
A higher GSRS indicate worse symptoms and a difference between D30 and last SBCE scores greater or equal to 0.3 can be considered as a clinically significant improvement in the symptoms."|one month|||GSRS score||95% Confidence Interval|Mean
762471|NCT00652899|Secondary|Median Overall Survival Number of Days Patients Alive After Treatment|Median number of days patients alive from date of treatment to date of death or date of last follow-up if censored.|From first date on-study (treatment) to date of death|||Days||95% Confidence Interval|Median
762472|NCT00652899|Secondary|Median Number of Days to Progression|Median number of days from first date of treatment to date of disease progression (appearance of new metastatic lesions or objective tumor progression). Defined by computated tomography (CT) imaging based on Response Evaluation Criteria In Solid Tumors (RECIST): Progressive Disease (PD) > or = 20% increase in sum of all target or any new lesions.|From date of first treatment to disease progression|||Days||95% Confidence Interval|Median
762546|NCT00653224|Secondary|Post-nasal Drip Score Over the First Week|The post-nasal drip score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided.|Over week 1|Number of participants from the ITT population with available post-nasal drip score over Week 1||points on a scale||Standard Deviation|Mean
762476|NCT00652938|Secondary|Number of Subjects Reporting Medically Significant Conditions|Medically significant conditions (i.e., AEs prompting emergency room or physician visits that are not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that are not related to common diseases).|Throughout the active phase of the study (up to Month 7)|Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.||subjects|||Number
762477|NCT00652938|Secondary|Number of Subjects Reporting Any and Causally Related to Vaccination SAEs|"SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
* Grade 3 SAEs were not assessed."|Throughout the safety follow-up (month 7 up to Month 12).|Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.||subjects|||Number
762478|NCT00652938|Secondary|Number of Subjects Reporting Any and Causally Related to Vaccination Serious Adverse Events (SAEs)|"SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Related SAEs were SAEs assessed by the investigators as related to the vaccination.
* Grade 3 SAEs were not assessed."|Throughout the active phase of the study (up to Month 7).|Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.||subjects|||Number
762479|NCT00652938|Secondary|Number of Subjects Reporting Any, Grade 3 and Causally Related to Vaccination Unsolicited Adverse Events (AEs)|"Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Grade 3 AE was an AE that prevented normal activities. Related AE was an AE that was assessed by the investigator as related to the study vaccination."|During the 30-day period (Days 0 - 29) following any vaccination|Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.||subjects|||Number
762480|NCT00652938|Secondary|Number of Subjects Reporting Related Solicited General Symptoms|"Solicited general symptoms included arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, temperature in degrees celsius (axillary) and urticaria.
Related solicited general symptoms were those symptoms assessed by the investigators as related to the study vaccination."|During the 7-day period (Days 0 - 6) following vaccination|Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.||subjects|||Number
762481|NCT00652938|Secondary|Number of Subjects Reporting Grade 3 Solicited General Symptoms|"Solicited general symptoms included arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, temperature in degrees celsius (axillary) and urticaria.
Grade 3 arthralgia, fatigue, gastrointestinal, headache, myalgia and rash were symptoms that prevented normal activity.
Grade 3 temperature was temperature > 39 degrees Celsius. Grade 3 urticaria was urticaria distributed on at least 4 body areas."|During the 7-day (Days 0-6) period following vaccination|Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.||subjects|||Number
762482|NCT00652938|Secondary|Number of Subjects Reporting Any Solicited General Symptoms|"Solicited general symptoms included arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, temperature in degrees celsius (axillary) and urticaria.
Any solicited general symptom is the occurence of the symptom regardless of its intensity or relationship to study vaccination."|During the 7-day (Days 0-6) period following vaccination.|Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.||subjects|||Number
762483|NCT00652938|Secondary|Number of Subjects Reporting Grade 3 Solicited Local Symptoms|"Solicited local symptoms include injection site pain, redness and swelling.
Grade 3 pain is pain that prevented normal everyday activities. Grade 3 redness is redness that was > 50 mm. Grade 3 swelling is swelling that was > 50 mm."|During the 7-day period (Days 0-6) following vaccination|Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.||subjects|||Number
762484|NCT00652938|Secondary|Number of Subjects Reporting Any Solicited Local Symptoms|"Solicited local symptoms included injection site pain, redness and swelling.
Any solicited local symptom is occurence of a symptom regardless of its intensity."|During the 7-day period (Days 0 - 6) following vaccination|Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.||subjects|||Number
762485|NCT00652938|Secondary|Anti-HBs Antibody Titers|"Anti-HBs antibody titers are given as GMTs in mIU/mL.
Only groups which had received the HBV vaccine were included in the analysis.
Subjects included were seronegative for anti-HBs (antibody titer < 3.3 mIU/mL) prior to vaccination."|Month 2|The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||mIU/mL||95% Confidence Interval|Geometric Mean
762486|NCT00652938|Secondary|Number of Subjects With Anti-Hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above the Cut-off Value for Seroprotection|"Only groups which had received the HBV vaccine were included in the analysis.
Subjects included were seronegative for anti-HBs (antibody titer < 3.3 milli International Units per milliliter (mIU/mL)) prior to vaccination vaccination.
Anti-HBs antibody cut-off value for seroprotection assessed included 10 mIU/mL."|Month 2|The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||subjects|||Number
762487|NCT00652938|Secondary|Number of Subjects With Anti-Hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above the Cut-off Value for Seroconversion|"Only groups which had received the HBV vaccine were included in the analysis.
Subjects included were seronegative for anti-HBs (antibody titer < 3.3 mIU/mL) prior to vaccination.
Anti-HBs antibody cut-off value for seroconversion assessed included 3.3 mIU/mL."|Month 2|The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||subjects|||Number
762501|NCT00653159|Secondary|Expulsion Rates|Rates of partial or complete expulsion for teens randomized to the LNG-IUS or Copper T 380A. Patients experiencing partial expulsion had IUDs visible on speculum exam. Complete expulsion is characterized by complete evacuation of the IUD.|6 months|All study participants were included in the analysis.||percentage of randomized subjects|||Number
762488|NCT00652938|Secondary|Anti-HPV-16/18 Antibody Titres|"Antibody titers for Anti-HPV-16 and Anti-HPV-18 are expressed as Geometric Mean Titers (GMTs).
Only groups which had received the HPV vaccine were included in the analysis.
Subjects included were seronegative for anti-HPV-16 (antibody titer < 8 EL.U/mL) and anti-HPV-18 (antibody titer < 7 EL.U/mL) prior to vaccination."|Month 2|The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
762489|NCT00652938|Secondary|Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations Above the Cut-off Value for Seroconversion|"Only groups which had received the HPV vaccine were included in the analysis.
Anti-HPV-16 antibody cut-off value assessed included 8 Enzyme-linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL) and anti-HPV-18 antibody cut-off value assessed included 7 EL.U/mL.
Subjects included were seronegative for anti-HPV-16 (antibody titer < 8 EL.U/mL) and anti-HPV-18 (antibody titer < 7 EL.U/mL) prior to vaccination."|Month 2|The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||subjects|||Number
762490|NCT00652938|Secondary|Anti-HBs Antibody Titres|"Antibody titers for anti-HBs are given as Geometric Mean Titers (GMTs) in mIU/mL.
Only groups which had received the HBV vaccine were included in the analysis.
Subjects included were seronegative for anti-HBs (antibody titer < 3.3 mIU/mL) prior to vaccination."|Month 7|The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||mIU/mL||95% Confidence Interval|Geometric Mean
762491|NCT00652938|Secondary|Number of Subjects With Anti-HBs Antibody Concentrations Above the Cut-off Value for Seroconversion|"Only groups which had received the HBV vaccine were included in the analysis.
Subjects included were seronegative for anti-HBs (antibody titer < 3.3 mIU/mL) prior to vaccination.
Anti-HBs antibody cut-off value for seroconversion assessed included 3.3 mIU/mL."|Month 7|The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||subjects|||Number
762492|NCT00652938|Primary|Anti-HPV-16/18 Antibody Titres|"Antibody titers for Anti-HPV-16 and Anti-HPV-18 are expressed as Geometric Mean Titers (GMTs).
Only groups which had received the HPV vaccine were included in the analysis.
Subjects included were seronegative for anti-HPV-16 (antibody titer < 8 EL.U/mL) and anti-HPV-18 (antibody titer < 7 EL.U/mL) prior to vaccination."|Month 7|The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
762493|NCT00652938|Primary|Number of Subjects With Anti-human Papillomavirus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibody Concentrations Above the Cut-off Value for Seroconversion|"Only groups which had received the HPV vaccine were included in the analysis.
Anti-HPV-16 antibody cut-off value assessed included 8 Enzyme-linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL) and anti-HPV-18 antibody cut-off value assessed included 7 EL.U/mL.
Subjects included were seronegative for anti-HPV-16 (antibody titer < 8 EL.U/mL) and anti-HPV-18 (antibody titer < 7 EL.U/mL) prior to vaccination."|Month 7|The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||subjects|||Number
762494|NCT00652938|Primary|Number of Subjects With Anti-Hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above the Cut-off Value for Seroprotection|"Only groups which had received the HBV vaccine were included in the analysis.
Subjects included were seronegative for anti-HBs (antibody titer < 3.3 milli International Units per milliliter (mIU/mL)) prior to vaccination.
Anti-HBs antibody cut-off value for seroprotection assessed included 10 mIU/mL."|Month 7|The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||subjects|||Number
762495|NCT00653068|Secondary|Non-hematological Toxicity Associated With Chemotherapy: Grade 3 or Higher During Protocol Therapy|Number of Participants with Nonhematological Toxicity Associated With Chemotherapy: Grade 3 or Higher During Protocol Therapy.|During protocol therapy up to 1 year after enrollment.|68 eligible patients were evaluable||Participants|||Count of Participants
762496|NCT00653068|Primary|Toxic Death|The number of patients who experience death that is considered to be primarily attributable to complications of treatment.|During and after completion of study treatment up to 1 year after enrollment.|One patient was ineligible in stratum I and one patient was ineligible in stratum III. There were no patients enrolled in Stratum 2 or 4.||Participants|||Count of Participants
762497|NCT00653068|Primary|Overall Survival (OS)|Estimated 4-year survival, where survival is calculated as the time from study enrollment to death from any cause or last follow-up alive whichever occurs first. Kaplan-Meier method is used for estimation. Patients alive at last contact are censored.|Up to 4 years after study enrollment|One patient was ineligible in stratum I and one patient was ineligible in stratum III. There were no patients enrolled in Stratum 2 or 4.||Estimated Probability||95% Confidence Interval|Number
762498|NCT00653068|Primary|Event-free Survival|Estimated 4-year EFS where EFS is calculated as the time from study enrollment to disease progression, disease relapse, occurrence of a second malignant neoplasm, death from any cause or last follow-up whichever occurs first. Kaplan-Meier method is used for estimation. Patients without an event are censored at last contact.|Up to 4 years after study enrollment|One patient was ineligible in stratum I and one patient was ineligible in stratum III. There were no patients enrolled in Stratum 2 or 4.||Estimated probability||95% Confidence Interval|Number
762499|NCT00653133|Primary|Complications of Peripheral Nerve Block|Adverse events related to performance of peripheral nerve catheter placement for continuous infusion of local anesthetic|Preoperative through 3 days post operative|Intent to treat (ITT)||participants|||Number
762500|NCT00653159|Secondary|Device Satisfaction Rates|"Satisfaction rate is the proportion of subjects who report being happy or very happy with their assigned intrauterine contraceptive method on the date of their 6 month study visit."|6 months|Only subjects who were not lost to follow-up at 6 months were included in this analysis.||percentage of subjects completing study|||Number
762502|NCT00653159|Secondary|Pregnancy Rates|Proportion of subjects who became pregnant within 6 months of IUD insertion|6 months|All study participants were included in the analysis.||percentage of randomized subjects|||Number
762505|NCT00653224|Secondary|Sleepiness According to Epworth Sleepiness Scale (ESS) Score at Baseline and at Endpoint During the Two-week Treatment Period|The Epworth Sleepiness Scale (ESS) is the criterion standard for measuring daytime sleepiness in adults. Subjects are asked to rate the chances of dozing off or falling asleep in eight situations encountered in daily life on a scale of 0 to 3, with scores ranging from 0 to 24. A score >= 8 indicates sleepiness. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population||participants|||Number
762506|NCT00653224|Secondary|Change From Baseline in Epworth Sleepiness Scale (ESS) Score at Week 2|The Epworth Sleepiness Scale (ESS) is the criterion standard for measuring daytime sleepiness in adults. Subjects are asked to rate the chances of dozing off or falling asleep in eight situations encountered in daily life on a scale of 0 to 3, with scores ranging from 0 to 24. A score >= 8 indicates sleepiness.|Baseline and week 2|Number of participants from the ITT population with available ESS score at Week 2 and at Baseline||points on a scale||Standard Deviation|Mean
762507|NCT00653224|Secondary|Change From Baseline in Epworth Sleepiness Scale (ESS) Score at Week 1|The Epworth Sleepiness Scale (ESS) is the criterion standard for measuring daytime sleepiness in adults. Subjects are asked to rate the chances of dozing off or falling asleep in eight situations encountered in daily life on a scale of 0 to 3, with scores ranging from 0 to 24. A score >= 8 indicates sleepiness.|Baseline and week 1|Number of participants from the ITT population with available ESS score at Week 1 and at Baseline||points on a scale||Standard Deviation|Mean
762508|NCT00653224|Secondary|Change From Baseline in Epworth Sleepiness Scale (ESS) Score at Endpoint During the Two-week Treatment Period|The Epworth Sleepiness Scale (ESS) is the criterion standard for measuring daytime sleepiness in adults. Subjects are asked to rate the chances of dozing off or falling asleep in eight situations encountered in daily life on a scale of 0 to 3, with scores ranging from 0 to 24. A score >= 8 indicates sleepiness. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population with available ESS score at Endpoint visit and at Baseline||points on a scale||Standard Deviation|Mean
762509|NCT00653224|Secondary|Change From Baseline in the Dimension 7 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Activity Impairment Due to Allergy at Week 2|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.|Baseline and week 2|Number of participants from the ITT population with available WPAI-AS score (dimension 7) at Week 2 and at Baseline||percent change||Standard Deviation|Mean
762510|NCT00653224|Secondary|Change From Baseline in the Dimension 7 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Activity Impairment Due to Allergy at Week 1|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.|Baseline and week 1|Number of participants from the ITT population with available WPAI-AS score (dimension 7) at Week 1 and at Baseline||percent change||Standard Deviation|Mean
762511|NCT00653224|Secondary|Change From Baseline in the Dimension 7 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Activity Impairment Due to Allergy at Endpoint During the Two-week Treatment Period|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population with available WPAI-AS score (dimension 7) at Endpoint visit and at Baseline||percent change||Standard Deviation|Mean
762512|NCT00653224|Secondary|Change From Baseline in the Dimension 6 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Classroom Impairment Due to Allergy at Week 2|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.|Baseline and week 2|Number of participants from the ITT population with available WPAI-AS score (dimension 6) at Week 2 and at Baseline||percent change||Standard Deviation|Mean
762513|NCT00653224|Secondary|Change From Baseline in the Dimension 6 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Classroom Impairment Due to Allergy at Week 1|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.|Baseline and week 1|Number of participants from the ITT population with available WPAI-AS score (dimension 6) at Week 1 and at Baseline||percent change||Standard Deviation|Mean
762514|NCT00653224|Secondary|Change From Baseline in the Dimension 6 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Classroom Impairment Due to Allergy at Endpoint During the Two-week Treatment Period|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population with available WPAI-AS score (dimension 6) at Endpoint visit and at Baseline||percent change||Standard Deviation|Mean
762544|NCT00653224|Secondary|Post-nasal Drip Score Over the Total Treatment Period (14 Days)|The post-nasal drip score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided.|Over total treatment period (14 days)|Number of participants from the ITT population with available post-nasal drip score over the Total Treatment period||points on a scale||Standard Deviation|Mean
762515|NCT00653224|Secondary|Change From Baseline in the Dimension 5 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment in the Classroom Due to Allergy at Week 2|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.|Baseline and week 2|Number of participants from the ITT population with available WPAI-AS score (dimension 5) at Week 2 and at Baseline||percent change||Standard Deviation|Mean
762516|NCT00653224|Secondary|Change From Baseline in the Dimension 5 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment in the Classroom Due to Allergy at Week 1|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.|Baseline and week 1|Number of participants from the ITT population with available WPAI-AS score (dimension 5) at Week 1 and at Baseline||percent change||Standard Deviation|Mean
762517|NCT00653224|Secondary|Change From Baseline in the Dimension 5 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment in the Classroom Due to Allergy at Endpoint During the Two-week Treatment Period|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population with available WPAI-AS score (dimension 5) at Endpoint visit and at Baseline||percent change||Standard Deviation|Mean
762518|NCT00653224|Secondary|Change From Baseline in the Dimension 4 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Class Time Missed Due to Allergy at Week 2|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.|Baseline and week 2|Number of participants from the ITT population with available WPAI-AS score (dimension 4) at Week 2 and at Baseline||percent change||Standard Deviation|Mean
762519|NCT00653224|Secondary|Change From Baseline in the Dimension 4 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Class Time Missed Due to Allergy at Week 1|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.|Baseline and week 1|Number of participants from the ITT population with available WPAI-AS score (dimension 4) at Week 1 and at Baseline||percent change||Standard Deviation|Mean
762520|NCT00653224|Secondary|Change From Baseline in the Dimension 4 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Class Time Missed Due to Allergy at Endpoint During the Two-week Treatment Period|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population with available WPAI-AS score (dimension 4) at Endpoint visit and at Baseline||percent change||Standard Deviation|Mean
762521|NCT00653224|Secondary|Change From Baseline in the Dimension 3 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Work Impairment Due to Allergy at Week 2|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.|Baseline and week 2|Number of participants from the ITT population with available WPAI-AS score (dimension 3) at Week 2 and at Baseline||percent change||Standard Deviation|Mean
762522|NCT00653224|Secondary|Change From Baseline in the Dimension 3 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Work Impairment Due to Allergy at Week 1|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.|Baseline and week 1|Number of participants from the ITT population with available WPAI-AS score (dimension 3) at Week 1 and at Baseline||percent change||Standard Deviation|Mean
762523|NCT00653224|Secondary|Change From Baseline in the Dimension 3 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Work Impairment Due to Allergy at Endpoint During the Two-week Treatment Period|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population with available WPAI-AS score (dimension 3) at Endpoint visit and at Baseline||percent change||Standard Deviation|Mean
762524|NCT00653224|Secondary|Change From Baseline in the Dimension 2 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment While Working Due to Allergy at Week 2|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.|Baseline and week 2|Number of participants from the ITT population with available WPAI-AS score (dimension 2) at Week 2 and at Baseline||percent change||Standard Deviation|Mean
762525|NCT00653224|Secondary|Change From Baseline in the Dimension 2 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment While Working Due to Allergy at Week 1|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.|Baseline and week 1|Number of participants from the ITT population with available WPAI-AS score (dimension 2) at Week 1 and at Baseline||percent change||Standard Deviation|Mean
762526|NCT00653224|Secondary|Change From Baseline in the Dimension 2 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment While Working Due to Allergy at Endpoint During the Two-week Treatment Period|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population with available WPAI-AS score (dimension 2) at Endpoint visit and at Baseline||percent change||Standard Deviation|Mean
762527|NCT00653224|Secondary|Change From Baseline in the Dimension 1 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Work Time Missed Due to Allergy at Week 2|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.|Baseline and week 2|Number of participants from the ITT population with available WPAI-AS score (dimension 1) at Week 2 and at Baseline||percent change||Standard Deviation|Mean
762528|NCT00653224|Secondary|Change From Baseline in the Dimension 1 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Work Time Missed Due to Allergy at Week 1|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.|Baseline and week 1|Number of participants from the ITT population with available WPAI-AS score (dimension 1) at Week 1 and at Baseline||percent change||Standard Deviation|Mean
762529|NCT00653224|Secondary|Change From Baseline in the Dimension 1 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Work Time Missed Due to Allergy at Endpoint During the Two-week Treatment Period|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population with available WPAI-AS score (dimension 1) at Endpoint visit and at Baseline||percent change||Standard Deviation|Mean
762530|NCT00653224|Secondary|Global Physician’s Rating of Efficacy at Endpoint During the Two Week Treatment Period|"Endpoint is defined as the last available postbaseline measurement during the two week treatment period.Physician had to tick a box going from Marked worsening to Marked improvement."|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population||participants|||Number
762531|NCT00653224|Secondary|Global Patient's Rating of Efficacy at Endpoint of the Two Week Treatment Period|"Endpoint is defined as the last available postbaseline measurement during the two week treatment period.Patient had to tick a box going from Marked worsening to Marked improvement."|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population||participants|||Number
762532|NCT00653224|Secondary|Ocular Redness Score Over the Total Treatment Period (14 Days)|The ocular redness score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided.|Over total treatment period (14 days)|Number of participants from the ITT population with available ocular redness score over the Total Treatment period||points on a scale||Standard Deviation|Mean
762533|NCT00653224|Secondary|Ocular Redness Score Over the Second Week|The ocular redness score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided.|Over week 2|Number of participants from the ITT population with available ocular redness score over Week 2||points on a scale||Standard Deviation|Mean
762534|NCT00653224|Secondary|Ocular Redness Score Over the First Week|The ocular redness score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided.|Over week 1|Number of participants from the ITT population with available ocular redness score over Week 1||points on a scale||Standard Deviation|Mean
762535|NCT00653224|Secondary|Ocular Tearing/Watering Score Over the Total Treatment Period (14 Days)|The ocular tearing/watering score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided.|Over total treatment period (14 days)|Number of participants from the ITT population with available ocular tearing/watering score over the Total Treatment period||points on a scale||Standard Deviation|Mean
762536|NCT00653224|Secondary|Ocular Tearing/Watering Score Over the Second Week|The ocular tearing/watering score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided.|Over week 2|Number of participants from the ITT population with available ocular tearing/watering score over Week 2||points on a scale||Standard Deviation|Mean
762537|NCT00653224|Secondary|Ocular Tearing/Watering Score Over the First Week|The ocular tearing/watering score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided.|Over week 1|Number of participants from the ITT population with available ocular tearing/watering score over Week 1||points on a scale||Standard Deviation|Mean
762538|NCT00653224|Secondary|Ocular Itching/Burning Score Over the Total Treatment Period (14 Days)|The ocular itching/burning score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided.|Over total treatment period (14 days)|Number of participants from the ITT population with available ocular itching/burning score over the Total Treatment period||points on a scale||Standard Deviation|Mean
762547|NCT00653224|Secondary|Nasal Pruritus Score Over the Total Treatment Period (14 Days)|The nasal pruritus score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided.|Over total treatment period (14 days)|Number of participants from the ITT population with available nasal pruritus score over the Total Treatment period||points on a scale||Standard Deviation|Mean
762548|NCT00653224|Secondary|Nasal Pruritus Score Over the Second Week|The nasal pruritus score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided.|Over week 2|Number of participants from the ITT population with available nasal pruritus score over Week 2||points on a scale||Standard Deviation|Mean
762549|NCT00653224|Secondary|Nasal Pruritus Score Over the First Week|The nasal pruritus score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided.|Over week 1|Number of participants from the ITT population with available nasal pruritus score over Week 1||points on a scale||Standard Deviation|Mean
762550|NCT00653224|Secondary|Nasal Congestion Score Over the Total Treatment Period (14 Days)|The nasal congestion score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided.|Over total treatment period (14 days)|Number of participants from the ITT population with available nasal congestion score over the Total Treatment period||points on a scale||Standard Deviation|Mean
762551|NCT00653224|Secondary|Nasal Congestion Score Over the Second Week|The nasal congestion score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided.|Over week 2|Number of participants from the ITT population with available nasal congestion score over Week 2||points on a scale||Standard Deviation|Mean
762552|NCT00653224|Secondary|Nasal Congestion Score Over the First Week|The nasal congestion score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided.|Over week 1|Number of participants from the ITT population with available nasal congestion score over Week 1||points on a scale||Standard Deviation|Mean
762553|NCT00653224|Secondary|Rhinorrhea Score Over the Total Treatment Period (14 Days)|The rhinorrhea score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided.|Over total treatment period (14 days)|Number of participants from the ITT population with available rhinorrhea score over the Total Treatment period||points on a scale||Standard Deviation|Mean
762554|NCT00653224|Secondary|Rhinorrhea Score Over the Second Week|The rhinorrhea score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided.|Over week 2|Number of participants from the ITT population with available rhinorrhea score over Week 2||points on a scale||Standard Deviation|Mean
762555|NCT00653224|Secondary|Rhinorrhea Score Over the First Week|The rhinorrhea score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided.|Over week 1|Number of participants from the ITT population with available rhinorrhea score over Week 1||points on a scale||Standard Deviation|Mean
762556|NCT00653224|Secondary|Sneezing Score Over the Total Treatment Period (14 Days)|The sneezing score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided.|Over total treatment period (14 days)|Number of participants from the ITT population with available sneezing score over the Total Treatment period||points on a scale||Standard Deviation|Mean
762557|NCT00653224|Secondary|Sneezing Score Over the Second Week|The sneezing score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided.|Over week 2|Number of participants from the ITT population with available sneezing score over Week 2||points on a scale||Standard Deviation|Mean
762558|NCT00653224|Secondary|Sneezing Score Over the First Week|The sneezing score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided.|Over week 1|Number of participants from the ITT population with available sneezing score over Week 1||points on a scale||Standard Deviation|Mean
762559|NCT00653224|Secondary|Total Ocular Symptom Score (TOSS) Over the Total Treatment Period (14 Days)|Total Ocular Symptoms Score (TOSS) is the sum of ocular itching/burning, ocular tearing/watering and ocular redness scores. Each individual symptom was scored from 0 (none) to 3 (severe). TOSS ranges from 0 to 9. An average over the total treatment period is provided.|Over total treatment period (14 days)|Number of participants from the ITT population with available TOSS over the Total Treatment period||points on a scale||Standard Deviation|Mean
762560|NCT00653224|Secondary|Total Ocular Symptom Score (TOSS) Over the Second Week|Total Ocular Symptoms Score (TOSS) is the sum of ocular itching/burning, ocular tearing/watering and ocular redness scores. Each individual symptom was scored from 0 (none) to 3 (severe). TOSS ranges from 0 to 9. An average over the second week of treatment is provided.|Over week 2|Number of participants from the ITT population with available TOSS over Week 2||points on a scale||Standard Deviation|Mean
762561|NCT00653224|Secondary|Total Ocular Symptom Score (TOSS) Over the First Week|Total Ocular Symptoms Score (TOSS) is the sum of ocular itching/burning, ocular tearing/watering and ocular redness scores. Each individual symptom was scored from 0 (none) to 3 (severe). TOSS ranges from 0 to 9. An average over the first week of treatment is provided.|Over week 1|Number of participants from the ITT population with available TOSS over Week 1||points on a scale||Standard Deviation|Mean
762562|NCT00653224|Secondary|Total Nasal Symptom Score (TNSS) Over the Total Treatment Period (14 Days)|Total Nasal Symptoms Score (TNSS) is the sum of sneezing, rhinorrhea, nasal itching, nasal congestion and post-nasal drip scores. Each individual symptom was scored from 0 (none) to 3 (severe). TNSS ranges from 0 to 15. An average over the total treatment period is provided.|Over total treatment period (14 days)|Number of participants from the ITT population with available TNSS over the Total Treatment period||points on a scale||Standard Deviation|Mean
762563|NCT00653224|Secondary|Total Nasal Symptom Score (TNSS) Over the Second Week|Total Nasal Symptoms Score (TNSS) is the sum of sneezing, rhinorrhea, nasal itching, nasal congestion and post-nasal drip scores. Each individual symptom was scored from 0 (none) to 3 (severe). TNSS ranges from 0 to 15. An average over the second week of treatment is provided.|Over week 2|Number of participants from the ITT population with available TNSS over Week 2||points on a scale||Standard Deviation|Mean
762564|NCT00653224|Secondary|Total Nasal Symptom Score (TNSS) Over the First Week|Total Nasal Symptoms Score (TNSS) is the sum of sneezing, rhinorrhea, nasal itching, nasal congestion and post-nasal drip scores. Each individual symptom was scored from 0 (none) to 3 (severe). TNSS ranges from 0 to 15. An average over the first week of treatment is provided.|Over week 1|Number of participants from the ITT population with available TNSS over Week 1||points on a scale||Standard Deviation|Mean
767742|NCT00697593|Primary|Hematology - Neutrophils|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 3 participants missing values||x10^9/L||Standard Deviation|Mean
762565|NCT00653224|Secondary|Total 4 Symptoms Score (T4SS) Over the Total Treatment Period (14 Days)|Total 4 Symptoms Score (T4SS) is the sum of rhinorrhea, sneezing, itchy nose and itchy eyes scores. Each individual symptom was scored from 0 (none) to 3 (severe). T4SS ranges from 0 to 12. An average over the total treatment period of 14 days is provided.|Over total treatment period (14 days)|Number of participants from the ITT population with available T4SS over the Total Treatment period||points on a scale||Standard Deviation|Mean
762566|NCT00653224|Secondary|Total 4 Symptoms Score (T4SS) Over the Second Week|Total 4 Symptoms Score (T4SS) is the sum of rhinorrhea, sneezing, itchy nose and itchy eyes scores. Each individual symptom was scored from 0 (none) to 3 (severe). T4SS ranges from 0 to 12. An average over the second week of treatment is provided.|Over week 2|Number of participants from the ITT population with available T4SS over Week 2||points on a scale||Standard Deviation|Mean
762567|NCT00653224|Secondary|Total 4 Symptoms Score (T4SS) Over the First Week|Total 4 Symptoms Score (T4SS) is the sum of rhinorrhea, sneezing, itchy nose and itchy eyes scores. Each individual symptom was scored from 0 (none) to 3 (severe). T4SS ranges from 0 to 12. An average over the first week of treatment is provided.|Over week 1|Number of participants from the ITT population with available T4SS over Week 1||points on a scale||Standard Deviation|Mean
762568|NCT00653224|Secondary|Total 5 Symptoms Score (T5SS) Over the Second Week|Total 5 Symptoms Score (T5SS) is the sum of rhinorrhea, sneezing, nasal congestion, itchy nose and itchy eyes scores. Each individual symptom was scored from 0 (none) to 3 (severe). T5SS ranges from 0 to 15. An average over the second week of treatment is provided.|Over week 2|Number of participants from the ITT population with available T5SS over Week 2||points on a scale||Standard Deviation|Mean
762569|NCT00653224|Secondary|Total 5 Symptoms Score (T5SS) Over the First Week|Total 5 Symptoms Score (T5SS) is the sum of rhinorrhea, sneezing, nasal congestion, itchy nose and itchy eyes scores. Each individual symptom was scored from 0 (none) to 3 (severe). T5SS ranges from 0 to 15. An average over the first week is provided.|Over week 1|Number of participants from the ITT population with available T5SS over Week 1||points on a scale||Standard Deviation|Mean
762570|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Emotional Score at Week 2|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated.|Baseline and week 2|Number of participants from the ITT population with available RQLQ emotional score at Visit 4 (Week 2) and at Baseline||points on a scale||Standard Deviation|Mean
762571|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Emotional Score at Week 1|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated.|Baseline and week 1|Number of participants from the ITT population with available RQLQ emotional score at Visit 3 (Week 1) and at Baseline||points on a scale||Standard Deviation|Mean
762572|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Emotional Score at Endpoint During the Two-week Treatment Period|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population with available RQLQ emotional score at Endpoint visit and at Baseline||points on a scale||Standard Deviation|Mean
762573|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Eye Symptoms Score at Week 2|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated.|Baseline and week 2|Number of participants from the ITT population with available RQLQ eye symptoms score at Visit 4 (Week 2) and at Baseline||points on a scale||Standard Deviation|Mean
762574|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Eye Symptoms Score at Week 1|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated.|Baseline and week 1|Number of participants from the ITT population with available RQLQ eye symptoms score at Visit 3 (Week 1) and at Baseline||points on a scale||Standard Deviation|Mean
762575|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Eye Symptoms Score at Endpoint During the Two-week Treatment Period|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population with available RQLQ eye symptoms score at Endpoint visit and at Baseline||points on a scale||Standard Deviation|Mean
762576|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Nasal Symptoms Score at Week 2|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated.|Baseline and week 2|Number of participants from the ITT population with available RQLQ nasal symptoms score at Visit 4 (Week 2) and at Baseline||points on a scale||Standard Deviation|Mean
762577|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Nasal Symptoms Score at Week 1|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated.|Baseline and week 1|Number of participants from the ITT population with available RQLQ nasal symptoms score at Visit 3 (Week 1) and at Baseline||points on a scale||Standard Deviation|Mean
764990|NCT00673179|Primary|Treatment Success (6 or Fewer Hospitalizations During Front-line Chemotherapy)|Treatment success defined as a patient having 6 or fewer hospitalizations during front-line chemotherapy.|Baseline to 5 Years|Study terminated early without analysis.|||||
762578|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Nasal Symptoms Score at Endpoint During the Two-week Treatment Period|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population with available RQLQ nasal symptoms score at Endpoint visit and at Baseline||points on a scale||Standard Deviation|Mean
762579|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Practical Problems Score at Week 2|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated.|Baseline and week 2|Number of participants from the ITT population with available RQLQ practical problems score at Visit 4 (Week 2) and at Baseline||points on a scale||Standard Deviation|Mean
762580|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Practical Problems Score at Week 1|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated.|Baseline and week 1|Number of participants from the ITT population with available RQLQ practical problems score at Visit 3 (Week 1) and at Baseline||points on a scale||Standard Deviation|Mean
762581|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Practical Problems Score at Endpoint During the Two-week Treatment Period|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population with available RQLQ practical problems score at Endpoint visit and at Baseline||points on a scale||Standard Deviation|Mean
762582|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Non-nose/Eye Symptoms Score at Week 2|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated.|Baseline and week 2|Number of participants from the ITT population with available RQLQ non-nose/eye symptoms score at Visit 4 (Week 2) and at Baseline||points on a scale||Standard Deviation|Mean
762583|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Non-nose/Eye Symptoms Score at Week 1|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated.|Baseline and week 1|Number of participants from the ITT population with available RQLQ non-nose/eye symptoms score at Visit 3 (Week 1) and at Baseline||points on a scale||Standard Deviation|Mean
762584|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Non-nose/Eye Symptoms Score at Endpoint During the Two-week Treatment Period|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population with available RQLQ non-nose/eye symptoms score at Endpoint visit and at Baseline||points on a scale||Standard Deviation|Mean
762585|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Sleep Score at Week 2|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated.|Baseline and week 2|Number of participants from the ITT population with available RQLQ sleep score at Visit 4 (Week 2) and at Baseline||points on a scale||Standard Deviation|Mean
762586|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Sleep Score at Week 1|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated.|Baseline and week 1|Number of participants from the ITT population with available RQLQ sleep score at Visit 3 (Week 1) and at Baseline||points on a scale||Standard Deviation|Mean
762587|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Sleep Score at Endpoint During the Two-week Treatment Period|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population with available RQLQ sleep score at Endpoint visit and at Baseline||points on a scale||Standard Deviation|Mean
762588|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Week 2|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated.|Baseline and week 2|Number of participants from the ITT population with available RQLQ activities score at Visit 4 (Week 2) and at Baseline||points on a scale||Standard Deviation|Mean
762589|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Week 1|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated.|Baseline and week 1|Number of participants from the ITT population with available RQLQ activities score at Visit 3 (Week 1) and at Baseline||points on a scale||Standard Deviation|Mean
762590|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Endpoint During the Two-week Treatment Period|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population with available RQLQ activities score at Endpoint visit and at Baseline||points on a scale||Standard Deviation|Mean
762591|NCT00653224|Secondary|Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Week 2|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Overall health-related quality of life is expressed as the mean of the seven dimension scores and ranges from 0 to 6.|Baseline and week 2|Number of participants from the ITT population with available overall RQLQ score at Visit 4 (Week 2) and at Baseline||points on a scale||Standard Deviation|Mean
762592|NCT00653224|Secondary|Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Week 1|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Overall health-related quality of life is expressed as the mean of the seven dimension scores and ranges from 0 to 6.|Baseline and week 1|Number of participants from the ITT population with available RQLQ overall score at Visit 3 (Week 1) and at Baseline||points on a scale||Standard Deviation|Mean
762593|NCT00653224|Secondary|Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Endpoint During the Two-week Treatment Period|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Overall health-related quality of life is expressed as the mean of the seven dimension scores and ranges from 0 to 6. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population with available overall RQLQ score at Endpoint visit and at Baseline||points on a scale||Standard Deviation|Mean
762594|NCT00653224|Primary|Mean 24-hour Reflective Total 5 Symptoms Score (T5SS) Over the Total Treatment Period (14 Days)|Total 5 Symptoms Score (T5SS) is the sum of rhinorrhea, sneezing, nasal congestion, itchy nose and itchy eyes scores. Each individual symptom was scored from 0 (none) to 3 (severe). Total score ranges from 0 to 15.|Over the total treatment period (14 days)|Number of participants from the Intent to treat (ITT) population with available T5SS over the Total Treatment Period||points on a scale||Standard Deviation|Mean
762595|NCT00653263|Secondary|Hamilton Depression Rating Scale (HAM-D) Rating Score|Hamilton Depression rating scale (HAM-D)is a scale that covers 21 symptoms with a total score of 0(best score)-62 (worst score) and a cutoff for moderate depression of 15 or above.|4 weeks|||"Units on a scale"||Standard Deviation|Mean
762596|NCT00653263|Primary|Methamphetamine Withdrawal Assessment (MAWA)|The Methamphetamine Withdrawal Assessment (MAWA) is a 13 item questionnaire which measures symptoms of methamphetamine withdrawal on a scale from 0(best score)-4(worst score). The total score ranges from 0(best score)-52(worst score).|Baseline through week 4|||"Units on a scale"||Standard Deviation|Mean
762597|NCT00653263|Primary|Methamphetamine Selective Severity Assessment (MSSA)|Methamphetamine Selective Severity Assessment (MSSA) is an 18 item questionnaire assessing withdrawal symptoms with each question measured on a scale from 0(best score)-7(worst score) for a range in scores from 0(best score)-126(worst score). Higher scores indicate more severe withdrawal symptoms.|Baseline through week 4|||"units on a scale"||Standard Deviation|Mean
762598|NCT00653328|Secondary|Number of Patients With Worst Grade Toxicities|Not all participants necessarily have an adverse event, thus not everyone will be accounted for in worst-grade toxicities. Likewise, one participant can potentially have more than one event in various grades 1-5 which accounts for the difference in number of patients analyzed and total number in the worst-grade toxicity tables. Tables represent the number of patients with worst-grade toxicity at each of five grades (grade 1, least severe; to grade 5, most severe) following NCI Common Toxicity Criteria|Weekly for 2 weeks, then monthly for 5 months|||participants|||Number
762599|NCT00653328|Secondary|Overall Survival||Date on study to date of death from any cause|All patients who received treatment. Two patients alive at last follow-up.||Months||Full Range|Median
762600|NCT00653328|Secondary|Number of Patients With Objective Response|"Patient response to treatment:
Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started, or appearance of >= 1 new lesions, and/or 2x CA-125 levels to >=70 IU/ml, confirmed by second measurement after 28 days Complete response (CR): disappearance of all target lesions Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD"|At month 2 and monthly thereafter to cessation of treatment|Patients who were available for measurement of tumor response.One patient withdrew after beginning treatment and was not available for measurement.||participants|||Number
762601|NCT00653328|Primary|Median Time to Tumor Progression|Tumor progression is determined by appropriate imaging techniques according to RECIST criteria or by CA-125 serum level >=2x baseline and >=70 IU/ml, confirmed by a second determination at least 28 days after the first determination|Date on study to the date of measured progressive disease, every 2 cycles (2 months)|Patients available for measurement of tumor response. One patient withdrew after beginning treatment.||Months||Full Range|Median
762602|NCT00653523|Primary|Number of Participants With Adverse Events and Adverse Reactions|"An adverse event is any unfavorable medical event occurring in a subject to whom an investigational product is administered, and a causal relationship between the administered investigational product and an adverse event is not always clarified.
That is, an adverse event is any unfavorable or unintended sign (including an abnormal change in laboratory test values), symptom, or disease, and a causal relationship to the relevant investigational product is not considered.
Any adverse event that was treatment-related was considered an adverse reaction."|Throughout 1 year of study|||Participants|||Number
762603|NCT00653861|Secondary|Nasolabial Fold (NLF) Severity|Determination of improvement in NLF severity score on 5-point NLF Severity Scale (0 = None; 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Extreme) two weeks after treatment with Juvederm with Lidocaine (either Ultra or Ultra Plus) in one nasolabial fold and Juvederm (either Ultra or Ultra Plus) in the other nasolabial fold.|2 weeks|ITT||Units on a scale||Standard Deviation|Mean
762604|NCT00653861|Secondary|Comparative Pain|A 5-point scale (-2 = Right NLF more painful than Left NLF; -1 = Right NLF slightly more painful than Left NLF; 0 = No difference; 1 = Left NLF slightly more painful than Right NLF; 2 = Left NLF more painful than Right NLF). Subjects selected one category from the scale; the percentage of subjects that selected each category is presented.|1 day|ITT||Percent of Participants|||Number
762605|NCT00653861|Primary|Procedural Pain Score|Evaluate pain on an 11-point scale, where 0 is no pain and 10 is the worst pain imaginable.|1 day|Intention to treat (ITT)||Units on a scale||Standard Deviation|Mean
762606|NCT00653939|Secondary|Coagulation NCI-CTCAE Grade 3 or 4 (Safety Population)||Day 1 (pretreatment) per 21-day Cycle (6 Cycles)|Safety Population||participants|||Number
762607|NCT00653939|Secondary|Hematology NCI-CTCAE Grade 3 or 4 (Safety Population)||Days 1 (pretreatment), 7, 14, and 21 per 21-day Cycle (6 Cycles)|Safety Population||participants|||Number
762608|NCT00653939|Secondary|Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population)||Days 1 (pretreatment) per 21-day Cycle (6 Cycles)|Safety Population||participants|||Number
762609|NCT00653939|Primary|Progression Free Survival (PFS) in the Intent-to-Treat Population|Progression was defined using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0. Based on 20% increase of the longest diameter of target lesions or appearance of one or more new non-target lesions or/and progression of non-target lesions since the treatment started.|Six 21-day cycles|Intent-to-Treat||months||95% Confidence Interval|Median
762610|NCT00653939|Secondary|Overall Survival (OS) Using a Multivariate Cox Regression Model in the Intent-to-Treat Population||Until death or lost to follow-up, up to 12 months since randomization|Intent-to-Treat||Months||95% Confidence Interval|Median
762611|NCT00653939|Secondary|Best Overall Tumor Response Rate (RR) in the Intent-to-Treat Population|Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 for target lesions (assessed by MRI or CT scan): Complete Response (CR) is defined as the disappearance of all target lesions, Partial Response (PR) is defined as at least a 30% decrease in the sum of the longest diameter of target lesions, Progressive Disease is defined as at least 20% increase in the sum of the longest diameter of target lesions, Stable Disease (SD) is defined as neither shrinkage to qualify for a PR or increase to qualify for a PD.|Six 21-day cycles|Intent-to-Treat||participants|||Number
762612|NCT00654004|Secondary|The Difference in Plasma Insulin Between Subjects With a Long-chain Fatty Acid Oxidation Disorder and Matched Controls Was Compared by T-test|Fasting insulin levels in uU/ml were measured in both groups. The differences between groups were compared with a t-test|Fasting insulin levels uUnits/ml|Study was designed as a one to one matching design. Thirteen subjects but only 12 controls completed the protocol. Samples were missing on one subject so 11 subjects were compared to 11 controls.||uU/ml||Standard Deviation|Mean
762613|NCT00654004|Secondary|The Difference in Plasma Leptin Between Subjects With a Long-chain Fatty Acid Oxidation Disorder and Matched Controls Was Compared by T-test|Fasting leptin in ng/kg fat mass were measured in both groups (subjects with a long-chain fatty acid oxidation disorder; controls). The differences between groups were compared with a t-test|Fasting leptin levels ng per kg of fat mass|Study was designed as a one to one matching design. Thirteen subjects but only 12 controls completed the protocol. We report results of 12 subjects and 12 matched controls.||ng/kg||Standard Deviation|Mean
762614|NCT00654004|Primary|An Outcome of This Study is the Difference in Glucose Tolerance Between Subjects With a Long-chain Fatty Acid Oxidation Disorder and Normal Controls.|"Glucose tolerance was estimated by the Matsuda Index using glucose and insulin values from a standard oral glucose tolerance test. The Matsuda Index is calculated by the following formula: 10,000/ sq root of (fasting glucose mg/dl X fasting insulin in units/ml) X (mean glucose (mg/dl) X mean insulin (units/ml) and correlates with insulin sensitivity measured by the gold standard method of a hyperinsulinemic euglycemic clamp. Values of 2.5 or greater are considered insulin sensitive. Values of 2.4 or less are considered insulin resistance.
The Matsuda Index of Insulin Sensitivity was measured in subjects with a long-chain fatty acid oxidation disorder (n=12). Twelve age, sex and BMI matched controls and 4 heterozygotes for a long-chain fatty acid oxidation disorder were recruited who also completed an oral glucose tolerance test. The difference in Mastuda Index between subjects and age matched controls was compared by t-test."|Subjects will be compared to controls at one point in time.|Study design was based on 1 to 1 matching of subjects and controls. Thirteen subjects but only 12 controls completed the protocol. We report results of 12 subjects compared to 12 matched controls.||units on a scale||Standard Deviation|Mean
762615|NCT00654004|Secondary|The Difference in Plasma Adiponectin Levels Between Subjects With a Long-chain Fatty Acid Oxidation Disorder and Matched Controls Was Compared by T-test|Fasting total adiponectin levels in ug/ml were measured in both groups (subjects with a long-chain fatty acid oxidation disorder). The differences between groups were compared with a t-test|Fasting total adiponectin (ug/ml)|Study was designed as a one to one matching design. Thirteen subjects but only 12 controls completed the protocol. We report results of 12 subjects and 12 matched controls.||ug/ml||Standard Deviation|Mean
762616|NCT00654004|Primary|An Outcome of This Study is the Difference in Percent Body Fat (%BF) Between Subjects With a Long-chain Fatty Acid Oxidation Disorder and Normal Controls.|Body composition by DEXA was measured in subjects with a long-chain fatty acid oxidation disorder (n=13). Twelve age, sex and BMI matched controls and 4 heterozygotes for a long-chain fatty acid oxidation disorder were recruited who also completed body composition measures. The difference in body composition between subjects and age matched controls was compared by t-test.|Subjects will be compared to controls at one point in time.|Study design was based on 1 to 1 matching of subjects and controls. Thirteen subjects but only 12 controls completed the protocol. We report results of 12 subjects compared to 12 matched controls.||percentage of body fat||Standard Deviation|Mean
762653|NCT00654381|Primary|Change From Baseline in HbA1c at Week 26|Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication|26 weeks|For the 26-week analysis, it was planed the comparison between Linagliptin and Voglibose. Then the patients with placebo were excluded in this analysis.Full analysis set for 26-week treatment period with Last Observation Carried Forward.||Percent||Standard Error|Least Squares Mean
762617|NCT00654030|Primary|Primary Outcome Measure: Immunological Response; Antigen Specific Reactions Will be Measured by IFN-ELISPOT. The ELISPOT is a Quantitative Readout of Number of T Cells That React to Specific Antigenic Stimulus.|The endpoint is immunologic response measured by IFN-ELISPOT. Increases above pre-vaccine levels (& controls) can be assessed statistically by ANOVA. Percent patients responding to vaccine (>2 Standard Deviation increase from baseline levels pre-vaccine) as well as magnitude of responses (relative ELISPOT measures) will be compared to results obtained using DC/1650 vaccine. The number of individuals responding (> 2 SD change from baseline vaccine) will provide an approximation of biologic efficacy of the vaccine.|Evaluated for 52 weeks|Per Protocol||Participants|||Number
762618|NCT00654095|Primary|Number of Participants With Adverse Events and Adverse Reactions|"An adverse event is any unfavorable medical event occurring in a subject to whom an investigational product is administered, and a causal relationship between the administered investigational product and an adverse event is not always clarified.
That is, an adverse event is any unfavorable or unintended sign (including an abnormal change in laboratory test values), symptom, or disease, and a causal relationship to the relevant investigational product is not considered.
Any adverse event that was considered treatment-related was considered an adverse reaction."|Throughout 1 year of study|||Participants|||Number
762619|NCT00654147|Primary|Time to Virologic Failure|time to virologic failure at week 24 (up to 48 weeks)|week 24 (up to 48 weeks)|||weeks||Standard Deviation|Median
762620|NCT00654147|Secondary|Study Medication Tolerability|study treatment tolerability as measured by number of subjects receiving study treatment who either discontinued or changed any component of study treatment|date started study treatment to first week documented change study treatment up to week 48|||participants|||Number
762621|NCT00654147|Secondary|Change From Baseline CD4+ and CD8+ Cell Counts|mean change in CD4+ and CD8+ T-lymphocytes counts from baseline (defined as the average of pre-entry and entry values) at weeks 16 and 24 in the two treatment arms|Baseline, Weeks 16 and 24|Change from baseline compared between arms using repeated measures analysis of covariance. Linear mixed models used to accomplish these analyses.||cells/mm3||Standard Error|Mean
762622|NCT00654147|Secondary|Weeks to HIV-1 RNA <200 Copies/ml|time to viral suppression noted as week on study treatment to attain HIV-1 RNA < 200 copies/ml|from date of treatment start to first week documented viral suppression|||week to viral supresssion||95% Confidence Interval|Median
762623|NCT00654147|Secondary|Study Medication Toxicity-related Discontinuation .|grade 3 and grade 4 symptoms and laboratory study treatment limiting toxicity|48 weeks|||participants|||Number
762624|NCT00654147|Primary|Time to Confirmed Virologic Failure|time to confirmed viologic failure at 24 weeks (up to 48 weeks)|weeks|descriptive||weeks||95% Confidence Interval|Median
762625|NCT00654186|Secondary|Time to Disesase Progression as Measured by Radiographic Progression|Progressive disease (PD) was determined, as outlined in the protocol, by using Recist 1.0. PD is defined as greater than or equal to a 20% increase in the sum of all measureable lesions or the apprearance of two new bone lesions or the appearnce of one new soft tissue lesion.|24 months|||months||Full Range|Median
762626|NCT00654186|Secondary|Time to PSA Progression|As defined in the protocol PSA progression was an increase of at least 25%|24 months for acrual|||months||Full Range|Median
762627|NCT00654186|Primary|Number of Participants With Overall Clinical Benefit (OCB), Defined as the Sum of Complete Response (CR), Partial Response (PR), and Stable Disease (SD) Divided by the Number of Participants|"The OCB was assessed using Recist 1.0 as defined in the protocol. A CR was defined as the disappearance of all lesions. A PR was defined as > or equal to a 30% decrease in the sum of the longest diameter of measureable lesions, SD was defined < a 30% decrease in the sum of the longest diameter of measureable lesions and < a 20% increase in the sum of the longest diameter of measureable lesions. For a CR, PR or SD, there are no new lesions.
Prostate-Specific Antigen (PSA) was also evaluated. A PSA CR was a PSA < or equal to 4 ng/dl. A PSA PR was a PSA that decreased by > or equal to 50%. Stable PSA was defined as a PSA that increased >25% and decreased < 50%."|24 months for acrual|evaluable patients||percentage of patients|||Number
762628|NCT00654329|Secondary|Length of Stay in PACU|Total time from PACU entry until discharge|up to 24 hours|||minutes||Standard Deviation|Mean
762629|NCT00654329|Primary|Incidence of Pain|Pain greater than a zero reported in the Post Anesthesia Care Unit (PACU)|up to 24 hours|||participants|||Number
762630|NCT00654355|Secondary|EASI|Eczema Area and Severity Index (EASI): Disease severity will be assessed by a physician with the Eczema Area and Severity Index (EASI). This measure is commonly used and well validated instrument of eczema severity. It is weighted for area in each of the four body regions (which differs for adults and children under 7) and scores erythema, excoriation, induration/papulation, and lichenification. The total scores range from 0-72. Higher scores represent more severe eczema.|Week 4|||units on a scale||Standard Deviation|Mean
762631|NCT00654355|Secondary|The % Change From Baseline to Week 4 (or End of Treatment) in the IGA.|Investigator Global Assessment: Investigator’s Global Assessment of severity integrates all lesions for overall score. This measure is commonly used as a quick and simple way to quantify disease severity both for clinical studies and in a non-study clinic setting. Score ranges from ‘0’ = clear or “No inflammatory signs of AD” to ‘4’ = Very Severe Disease with “severe erythema and severe papulation/infiltration with oozing/crusting.”|Week 4|||% change in IGA||95% Confidence Interval|Median
762632|NCT00654355|Primary|Adherence|"adherence to topical therapy in children via MEMS cap in a real-life clinic population measured as the % of required applications completed"|Week 4|||percentage of required applicaitons||95% Confidence Interval|Median
762633|NCT00654368|Secondary|Number of Participants With Adverse Events (AEs)|A serious adverse event (SAE) is defined by regulatory authorities as one that: • is fatal • is life threatening • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • other significant medical hazard.|25 months|Safety Analysis Set||participants|||Number
762654|NCT00654381|Primary|Change From Baseline in HbA1c at Week 12|Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication|12 weeks|For the 12-week analysis, it was planed the comparison between Linagliptin and placebo. Then the patients with voglibose were excluded in this analysis.Full analysis set for 12-week treatment period with Last Observation Carried Forward.||Percent||Standard Error|Least Squares Mean
762634|NCT00654368|Secondary|Change From Month 6 in Treatment Satisfaction Questionnaire for Medication (TSQM)|The Treatment Satisfaction Questionnaire for Medication is a 14-item self-administered questionnaire which measures patients’ experiences with their medication on four dimensions: effectiveness, side effects, convenience and global satisfaction. Optional responses are: Extremely Dissatisfied (1), Very Dissatisfied (2), Dissatisfied (3), Somewhat Satisfied (4), Satisfied (5), Very Satisfied (6), and Extremely Satisfied (7). For each dimension, responses are added and transformed to a scale from 0 – 100, where higher scores indicate greater satisfaction. Change from Month 6 is reported for each dimension; a positive change score indicates improvement. End of study is Month 24 or early termination.|Month 6, 12, 18 and 24|Intent to treat analysis set with available data; LOCF. n indicates the number of participants with available data at each time point.||scores on a scale||Standard Deviation|Mean
762635|NCT00654368|Secondary|Change From Month 6 in Work Productivity and Activity Impairment (WPAI)|This 6-item assessment measures productivity losses during the past 7 days and includes measures on work time missed due to health, impairment while working due to health (the participant’s assessment of the degree to which health affected their productivity while working), overall work impairment due to health (takes into account both hours missed due to health and the participant’s assessment of the degree to which health affected their productivity while working) and activity impairment due to health (the degree in which health problems affected their ability to do regular daily activities). Scores for each measure are expressed from 0 to 100 with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. For each measure change from Month 6 is reported; a negative change score indicates improvement. End of study is month 24 or early termination.|Month 6, 12, 18 and 24|Intent to treat analysis set with available data; Work time missed and work impairment scores are only calculated for participants who were employed at the time. LOCF imputation was used.||scores on a scale||Standard Deviation|Mean
762636|NCT00654368|Secondary|Change From Month 6 in Short Form 36 Health Survey (SF-36)|"The SF-36 assesses the general quality of life (QOL) of participants by evaluating the domains of physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The questionnaire consists of 36 questions that are completed by the participant.
The SF-36 is split into two major components: physical health and mental health. Under physical health are the following four domains: physical health, bodily pain, physical functioning and physical role limitations. Under the mental health domain there are four domains; mental health, vitality, social functioning, and emotional role limitation. The individual domain scores are aggregated to derive a physical-component summary score and a mental-component summary score which range from 0 to 100, with higher scores indicating a better level of functioning.
End of study is month 24 or early termination."|Month 6, 12, 18 and 24|Intent to treat analysis set with available SF-36 data at month 6; LOCF||scores on a scale||Standard Deviation|Mean
762637|NCT00654368|Secondary|Change From Month 6 in Health Assessment Questionnaire Pain Visual Analog Scale (VAS)|The HAQ pain visual analog scale (VAS) is a measure of pain on a continuous 100 point scale. Participants were asked to indicate how much pain they had in the past week as a result of their illness on a horizontal line from 0 (no pain) to 100 (severe pain). End of study is Month 24 or early termination.|Month 6, 12, 18 and 24|Intent to treat analysis set with available data; LOCF||scores on a scale||Standard Deviation|Mean
762638|NCT00654368|Secondary|Change From Month 6 in Health Assessment Questionnaire Disability Index (HAQ DI)|The HAQ disability index is a patient-reported questionnaire specific for rheumatoid arthritis that addresses health-related quality of life. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants choose from four response categories, ranging from 'without any difficulty' (score=0) to 'unable to do' (score=3). The overall score is the average of each of the 8 category scores and ranges from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A negative change score indicates an improvement. End of study is Month 24 or early termination.|Month 6, 12, 18 and 24|Intent to treat analysis set; LOCF||scores on a scale||Standard Deviation|Mean
762639|NCT00654368|Secondary|Change From Baseline in Joint Space Narrowing|"X-rays of hands and feet were read centrally and in a blinded manner. Joint space narrowing (JSN) scores were recorded for each hand/wrist (15 joints) and each foot (6 joints) on a 5-point scale scored as follows:
0 = normal; 1 = focal or doubtful; 2 = generalised, less than 50% of the original joint space; 3 = generalised, more than 50% of the original joint space or subluxation; 4 = bony ankylosis or complete luxation. The scores were summed to calculate the total JSN score ranging from 0 to 168 (worst). A large increase in joint narrowing score is indicative of worsening, whereas a small change or no change is indicative of inhibition of JSN.
End of study is Month 24 or early termination."|Baseline, Month 12 and Month 24|Radiographic Analysis Set - All randomized participants with a baseline and at least 1 post baseline radiographic assessment. LOCF imputation was used.||scores on a scale||Standard Deviation|Mean
762640|NCT00654368|Secondary|Change From Baseline in Joint Erosion Score|X-rays of hands and feet were read centrally and in a blinded manner. Sixteen joints on each hand/wrist and 6 joints on each foot were scored for erosions on a scale of 0 to 5 (or for the feet from 0 to 10, with each side of the joint independently scored from 0 to 5) according to the following: One point is scored if erosions are discrete, rising to 2, 3, 4, or 5 depending on the amount of surface area affected (complete collapse of the bone is scored as 5). Scores were summed to calculate the total erosion score, which ranges from 0 (no erosion) to 280 (worst). A large increase in erosion score is indicative of worsening, whereas a small change or no change is indicative of inhibition of joint erosion. End of study is Month 24 or early termination.|Baseline, Month 12 and Month 24|Radiographic Analysis Set - All randomized participants with a Baseline and at least 1 post baseline radiographic assessment. LOCF imputation was used.||scores on a scale||Standard Deviation|Mean
762663|NCT00654498|Secondary|The Mean Change From Baseline in the Severity of RLS During the Night of RLS-6 Rating Scales.|RLS-6 rating scales comprises 6 questions. The severity of RLS during the night is one of the 6 questions. The patient should give a rate between 0 (“none/Not at all”) to 10 (“very severe”) for the severity of RLS during the night.|Baseline and 6 weeks of treatment|||Score on a scale||Standard Deviation|Mean
762664|NCT00654498|Secondary|The Mean Change From Baseline in the Severity of RLS at Time of Falling Sleep of RLS-6 Rating Scales.|RLS-6 rating scales comprises 6 questions. The severity of RLS at time of falling sleep is one of the 6 questions. The patient should give a rate between 0 (none/Not at all) to 10 (very severe) for the severity of RLS at time of falling sleep|Baseline and 6 weeks of treatment|||Score on a scale||Standard Deviation|Mean
762641|NCT00654368|Secondary|Change From Baseline in Modified Total Sharp Score (mTSS)|The modified Total Sharp Score (mTSS) is a measure of change in joint health. X-rays of hands and feet were scored in a blinded manner by an independent reader. Joints were scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (bony ankylosis or complete luxation). Erosion scores and narrowing scores were added to obtain the total mTSS score, ranging from 0 (normal) to 448 (maximal disease). An increase in mTSS from Baseline (represented by a positive change from Baseline score) indicates disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease (negative change from Baseline score) represents improvement. End of study is Month 24 or early termination.|Baseline, Month 12 and Month 24|Radiographic Analysis Set - All randomized participants with a baseline and at least 1 post baseline radiographic assessment. LOCF imputation was used.||scores on a scale||Standard Deviation|Mean
762642|NCT00654368|Secondary|Drug Persistence|Drug persistence is defined as the percentage of participants receiving etanercept at 6, 12, 18, and 24 months.|Month 6, 12, 18 and 24|Intent to Treat Analysis Set||percentage of participants|||Number
762643|NCT00654368|Secondary|Change From Baseline in Disease Activity Score 28 (DAS28)|The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables: • The number of swollen and tender joints assessed using the 28-joint count; • Erythrocyte sedimentation rate (ESR); • Patient's global assessment of disease activity measured on a 100 mm visual analog scale. The DAS28 score ranges from zero to ten. A DAS28 score above 5.1 means high disease activity whereas a DAS28 less than or equal to 3.2 indicates low disease activity. In this study, the mean changes in DAS28 scores from Baseline were multiplied by a factor of -1, such that a negative change in DAS28 indicates worsening in disease activity. End of study is Month 24 or early termination.|Baseline and Month 6, 12, 18 and 24|Intent to treat; LOCF. The number of participants with available data at Month 6 was 95 and 105 in each treatment group respectively.||scores on a scale||Standard Deviation|Mean
762644|NCT00654368|Secondary|Disease Activity Score (DAS) 28 Response|The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables: • The number of swollen and tender joints assessed using the 28-joint count; • Erythrocyte sedimentation rate (ESR); • Patient's global assessment of disease activity measured on a 100 mm visual analog scale. The DAS28 score ranges from zero to ten. Remission is defined by a DAS28 score less than 2.6. Low disease activity is defined by a DAS28 score less than or equal to 3.2. Moderate is defined as a DAS28 higher than 3.2 but lower than or equal to 5.1. DAS28 above 5.1 indicates high disease activity. End of study is Month 24 or early termination.|Month 6, 12, 18 and 24|Intent to treat population (all randomized participants); Last observation carried forward (LOCF) imputation was used. At Month 6 data were available for 95 and 105 participants in each treatment group respectively.||Percentage of participants||95% Confidence Interval|Number
762645|NCT00654368|Primary|Change From Month 6 to Month 12 in Disease Activity Sscore 28 (DAS28)|The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables: • The number of swollen and tender joints assessed using the 28-joint count; • Erythrocyte sedimentation rate (ESR); • Patient's global assessment of disease activity measured on a 100 mm visual analog scale. The DAS28 score ranges from zero to ten. A DAS28 score above 5.1 means high disease activity whereas a DAS28 less than or equal to 3.2 indicates low disease activity. In this study, the mean change in DAS28 scores from Month 6 to Month 12 was multiplied by a factor of -1, such that a negative change in DAS28 indicates worsening in disease activity.|Month 6 (randomization) and Month 12|The per protocol population defined as all randomized participants with DAS28 measurements both at the 6- and 12-month visit.||scores on a scale||Standard Error|Least Squares Mean
762646|NCT00654381|Primary|Examination of Long-term Safety of Linagliptin (52-week Treatment)|The incidence of AEs (Preferred Terms) with a frequency of 5% or more in the patients with type 2 diabetes mellitus who received linagliptin (5 mg or 10 mg) once daily for 52 weeks|52 weeks|The patients who received at least one dose of linagliptin 5 mg or linagliptin 10 mg during the randomised treatment period||participants|||Number
762647|NCT00654381|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52|Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication|52 weeks|The patients who had at least one available baseline FPG measurement under the treatment with linagliptin||mg/dL||Standard Error|Least Squares Mean
762648|NCT00654381|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26|Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication|26 weeks|For the 26-week analysis, it was planed the comparison between Linagliptin and Voglibose. Then the patients with placebo were excluded in this analysis.Full analysis set for 26-week treatment period with Last Observation Carried Forward||mg/dL||Standard Error|Least Squares Mean
762649|NCT00654381|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12|Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication|12 weeks|For the 12-week analysis, it was planed the comparison between Linagliptin and placebo. Then the patients with voglibose were excluded in this analysis.Full analysis set for 12-week treatment period with Last Observation Carried Forward.||mg/dL||Standard Error|Least Squares Mean
762650|NCT00654381|Secondary|Relative Efficacy Response of HbA1c at Week 52|HbA1c value decreased below 7.0%, below 6.5% and reduction from baseline ≥0.5% at Week 52|52 weeks|For the 52-week analysis, it was planed to analyse for Linagliptin 5mg and 10mg. Then the patients with placebo and voglibose were excluded in this analysis. Full analysis set for 52-week treatment period with Last Observation Carried Forward||Participants|||Number
762651|NCT00654381|Secondary|Relative Efficacy Response of HbA1c at Week 26|HbA1c value decreased below 7.0%, below 6.5% and reduction from baseline ≥0.5% at Week 26|26 weeks|For the 26-week analysis, it was planed the comparison between Linagliptin and Voglibose. Then the patients with placebo were excluded in this analysis.Full analysis set for 26-week treatment period with Last Observation Carried Forward.||Participants|||Number
762652|NCT00654381|Secondary|Relative Efficacy Response of HbA1c at Week 12|HbA1c value decreased below 7.0%, below 6.5% and reduction from baseline ≥0.5% at Week 12|12 weeks|For the 12-week analysis, it was planed the comparison between Linagliptin and placebo. Then the patients with voglibose were excluded in this analysis.Full analysis set for 12-week treatment period with Last Observation Carried Forward.||Participants|||Number
762655|NCT00654420|Secondary|Phase II: Percentage of Participants With Complete Response (CR) or Partial Response (PR) After Dalotuzumab Plus Erlotinib Treatment (Objective Response Rate [ORR])|"ORR was defined as the percentage of participants in the Phase II analysis population having complete response (CR) or partial response (PR) during the course of the study.
RECIST criteria were used to quantify response rate. For evaluation of target lesions, CR was defined as disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of the LD. For evaluation of non-target lesions, CR was defined as disappearance of all non-target lesions and normalization of tumor marker level.
Confirmation of response required a second assessment performed 4 weeks or more after the initial assessment. If the confirmation assessment contradicted the initial assessment, it was considered that a response had not been observed. If the confirmation assessment of a participant was not available, that participant was not considered as a responder in the response rate analyses."|Duration of time required to collect approximately 49 deaths or PFS events (assessed up to ~20 months total on this study from randomization to cut-off date)|All randomized participants in Phase II who received ≥1 dose of study treatment, had a baseline radiological (CT or MRI) disease assessment, and had ≥1 post-baseline radiological (CT or MRI) disease assessment subsequent to ≥1 dose of study treatment for reason other than discontinuation for AE. Phase I participants were not assessed for ORR.||percentage of participants||95% Confidence Interval|Number
762656|NCT00654420|Secondary|Phase II: Median Overall Survival (OS) in Participants Receiving Dalotuzumab Plus Erlotinib Treatment|OS was defined as the time from randomization to death in months due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. The nonparametric Kaplan-Meier method was used to estimate the survival time distribution and the median survival of each treatment group.|Duration of time required to collect approximately 49 deaths or PFS events (assessed up to ~20 months total on this study from randomization to cut-off date)|Intent to Treat (IIT) Population; all randomized participants in Phase II included regardless of compliance to planned treatment. Phase I participants were not assessed for OS.||months||95% Confidence Interval|Median
762657|NCT00654420|Primary|Phase II: Median Progression Free Survival (PFS) in Participants Receiving Dalotuzumab Plus Erlotinib Treatment|PFS was defined as the time from randomization until either the emergence of radiographic evidence of disease progression or death due to any cause, whichever occurs first. Disease progression was classified as a radiographic assessment of progressive disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) using computed tomography (CT) or magnetic resonance imaging (MRI). As pre-specified by the protocol, final analysis of PFS was to take place after approximately 49 PFS events or deaths had occurred in the Phase II part of the trial. A non-parametric Kaplan-Meier method was used to estimate the median PFS time for each treatment group. Participants who discontinued from the study for reasons other than progression of disease were treated as right-censored observations at the time of the last response evaluation. Participants who withdrew from the study due to PD were considered to have a disease progression between the last visit and the time of withdrawal.|Duration of time required to collect approximately 49 deaths or PFS events (assessed up to ~20 months total on this study from randomization to cut-off date)|All randomized participants in Phase II who received ≥1 dose of study treatment, had a baseline radiological (CT or MRI) disease assessment, and had ≥1 post-baseline radiological (CT or MRI) disease assessment subsequent to ≥1 dose of study treatment for reason other than discontinuation for AE. Phase I participants were not assessed for PFS.||months||95% Confidence Interval|Median
762658|NCT00654420|Primary|Phase I: Number of Participants Experiencing at Least One Dose-Limiting Toxicity (DLT) Adverse Event (AE) During the First Four Weeks of Dalotuzumab Plus Erlotinib Treatment|"A DLT was an AE related (definitely, probably, or possibly) to study therapy and occurring within first 4 weeks of therapy.
Hematologic DLTs included Grade (Gr)4 neutropenia lasting for ≥7 days, Gr 3/Gr 4 neutropenia with fever >38.5 °C and/or infection requiring antibiotic or anti-fungal treatment, and Gr 4 thrombocytopenia (25.0 x 10^9/L).
Non-hematologic DLT defined as any ≥Gr 3 nonhematologic toxicity, except Gr 3 reversible rash; Gr 3 nausea, vomiting, diarrhea, dehydration, or hyperglycemia occurring in setting of inadequate compliance with supportive care; alopecia; anorexia; asthenia; inadequately-treated hypersensitivity reactions; Gr 3 elevated transaminases (≤1 week duration); or infusion reactions to dalotuzumab.
Any drug-related AEs that led to dose modification of dalotuzumab/erlotinib or any unresolved drug-related toxicity that caused a ≥3 week delay of next scheduled dose of study drug, regardless of Common Terminology Criteria grade, were DLTs."|Up to 4 weeks after initiation of treatment|Participants in the Phase I part of the study who received at least one dose of dalotuzumab in combination with erlotinib during the first 4 weeks of treatment and were evaluable for DLT assessment. Participants in the Phase II part of the study were not evaluated for DLTs.||participants|||Number
762659|NCT00654498|Secondary|The Change From Baseline in Visual Analogue Scales (VAS)|VAS is for assessment of RLS-associated pain. The patient was asked “How severe was your RLS associated pain in legs or arms during the past week?”. No pain:0; very worst pain:10|Baseline and 6 weeks of treatment|||Score on a scale||Standard Deviation|Mean
762660|NCT00654498|Secondary|The Mean Change From Baseline in the Intensity of Tiredness and Sleepiness at Day of RLS-6 Rating Scale|RLS-6 rating scales comprises 6 questions. The intensity of tiredness and sleepiness at day is one of the 6 questions. The patient should give a rate between 0 (“none/Not at all”) to 10 (“very severe”) for the intensity of tiredness and sleepiness at day.|Baseline and 6 weeks of treatment|||Score on a scale||Standard Deviation|Mean
762661|NCT00654498|Secondary|The Mean Change From Baseline in the Severity of RLS During the Activities at Day of RLS-6 Rating Scale|RLS-6 rating scales comprises 6 questions. The severity of RLS during the activities at day is one of the 6 questions. The patient should give a rate between 0 (“none/Not at all”) to 10 (“very severe”) for the severity of RLS during the activity at day.|Baseline and 6 weeks of treatment|||Score on a scale||Standard Deviation|Mean
762662|NCT00654498|Secondary|The Mean Change From Baseline in the Severity of RLS During the Rest at Day of RLS-6 Rating Scales.|RLS-6 rating scales comprises 6 questions. The severity of RLS during the test at day is one of the 6 questions. The patient should give a rate between 0 (“none/Not at all”) to 10 (“very severe”) for the severity of RLS during the rest at day.|Baseline and 6 weeks of treatment|||Score on a scale||Standard Deviation|Mean
767743|NCT00697593|Primary|Hematology - White Blood Cell Count|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 3 participants missing values||x10^9/L||Standard Deviation|Mean
762665|NCT00654498|Secondary|the Mean Change From Baseline to Week 6 in Satisfaction of Sleep at Night of RLS-6 Rating Scales|RLS-6 rating scales comprises 6 questions Satisfaction of sleep is one of the 6 questions. The patient should give a rate between 0 (none/Not at all) to 10 (very severe) for the satisfaction of sleep.|Baseline and 6 weeks of treatment|||Score on a scale||Standard Deviation|Mean
762666|NCT00654498|Secondary|The Proportion of Patients With Epworth Sleepiness Scale (ESS) Categorised >10|The ESS is a self-administered instrument to assess the patients likelihood of falling asleep in various activities of daily living; the maximum score is 24 indicating a very high level of daytime sleepiness and a high likelihood of falling asleep.|week 6 of treatment|||Proportion of Patients|||Number
762667|NCT00654498|Secondary|The Proportion of Patient Global Impression(PGI) Responders|"PGI was a one-question scale with 7 degrees to assess patient's overall condition, ranging from very much better to very much worse. The responder are defined as patients with their assessment of much better or very much better."|6 weeks of treatment|||Proportion of participants|||Number
762668|NCT00654498|Secondary|The Proportion of IRLS Responders|responders is defined as the total score in IRLS changed ≥ 50%from baseline calculated in the full analysis set population.|6 weeks of treatment|||Proportion of Patients|||Number
762669|NCT00654498|Primary|"The Proportion of Patients With Clinical Global Impressions -Improvement Scale (CGI-I) Assessment of Much Improved and Very Much Improved"|CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved)and 2 (much improved.|6 weeks of treatment|||Proportion of Patients|||Number
762670|NCT00654498|Primary|The Change From Baseline to Week 6 in the Total Score of Restless Legs Syndrome Rating Scale for Severity of the International Restless Legs Syndrome Study Group (IRLS).|The IRLS was a 10-item self patient's rating scale for assessing severity of restless legs syndrome symptoms with each item ranging from 0 (no symptoms) to 4 (very severe symptoms). The total IRLS score ranges from 0 (no symptoms) to 40 (worst possible symptoms).|Baseline and 6 weeks of treatment|Full Analysis Set (FAS), All patients randomized, treated, having data for primary endpoint||Score on a scale||Standard Error|Least Squares Mean
762671|NCT00654511|Primary|Morphine Rescue|Total morphine administered in the Post Anesthesia Care Unit (PACU)|up to 24 hours|||micrograms/kilogram||Standard Deviation|Mean
762672|NCT00654511|Primary|Time to First Morphine Dose|Total minutes from study medication administration to time of first morphine dose.|up to 24 hours|||minutes||Standard Deviation|Mean
762673|NCT00654628|Other Pre-specified|Mean Change From Baseline of Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12||Baseline and week 12|Intention-To-Treat(ITT) approach which included all participants who have baseline measurement, have taken at least one dose of the study drug, and have at least one post-baseline measurement||mg/dL||Standard Deviation|Mean
762674|NCT00654628|Secondary|Mean Percent Change of Triglycerides From Baseline at Week 12||Baseline and week 12|Intention-To-Treat(ITT) approach which included all participants who have baseline measurement, have taken at least one dose of the study drug, and have at least one post-baseline measurement||Percent Change||Inter-Quartile Range|Median
762675|NCT00654628|Secondary|Mean Percent Change From Baseline of High Density Lipoprotein-C (HDL-C) at Week 12||Baseline and week 12|Intention-To-Treat(ITT) approach which included all participants who have baseline measurement, have taken at least one dose of the study drug, and have at least one post-baseline measurement||Percent Change||Standard Deviation|Mean
762676|NCT00654628|Secondary|Mean Percent Change From Baseline of Total-Cholesterol (TC) at Week 12||Baseline and week 12|Intention-To-Treat(ITT) approach which included all participants who have baseline measurement, have taken at least one dose of the study drug, and have at least one post-baseline measurement||Percent Change||Standard Deviation|Mean
762677|NCT00654628|Secondary|Mean Percent Change From Baseline of Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12||Baseline and week 12|Intention-To-Treat(ITT) approach which included all participants who have baseline measurement, have taken at least one dose of the study drug, and have at least one post-baseline measurement||Percent Change||Standard Deviation|Mean
762678|NCT00654628|Other Pre-specified|Mean Change From Baseline of Low Density Lipoprotein-Cholesterol (LDL-C) at Week 6||Baseline and week 6|Intention-To-Treat(ITT) approach which included all participants who have baseline measurement, have taken at least one dose of the study drug, and have at least one post-baseline measurement||mg/dL||Standard Deviation|Mean
762679|NCT00654628|Secondary|Mean Percent Change of Triglycerides From Baseline at Week 6||Baseline and week 6|Intention-To-Treat(ITT) approach which included all participants who have baseline measurement, have taken at least one dose of the study drug, and have at least one post-baseline measurement||Percent Change||Inter-Quartile Range|Median
762680|NCT00654628|Secondary|Mean Percent Change From Baseline of High Density Lipoprotein-C (HDL-C) at Week 6||Baseline and week 6|Intention-To-Treat(ITT) approach which included all participants who have baseline measurement, have taken at least one dose of the study drug, and have at least one post-baseline measurement||Percent Change||Standard Deviation|Mean
762681|NCT00654628|Secondary|Mean Percent Change From Baseline of Total-Cholesterol (TC) at Week 6||Baseline and week 6|Intention-To-Treat(ITT) approach which included all participants who have baseline measurement, have taken at least one dose of the study drug, and have at least one post-baseline measurement||Percent Change||Standard Deviation|Mean
762682|NCT00654628|Secondary|Mean Percent Change From Baseline of Low Density Lipoprotein-Cholesterol (LDL-C) at Week 6||Baseline and week 6|Intention-To-Treat(ITT) approach which included all participants who have baseline measurement, have taken at least one dose of the study drug, and have at least one post-baseline measurement||Percent Change||Standard Deviation|Mean
762683|NCT00654628|Primary|The Percentage of Participants Achieving Low Density Lipoprotein-C (LDL-C) Treatment Goal After 12-week Treatment.|Goal attainment percentage of LDL-C after 12-week treatment. LDL-C goal attainment was based on National Cholesterol Education program (NCEP) Adult Treatment Panel (ATP) III guidelines (2004). Newly Diagnosed Dyslipidemia Patients Including: 1)Intermediate Risk (>2 Risk Factors) with Total Cholesterol above 200 mg/dL or Low Density Lipoprotein C (LDL-C) level >130 who failed a 3-month diet control period, or 2) high risk patients with a history of coronary artery disease or diabetes having a total cholesterol >200 mg/dl or LDL-C level >130 mg/dl.|Baseline and week 12|Intention-To-Treat (ITT) approach which included all participants who have baseline measurement, have taken at least one dose of the study drug, and have at least one post-baseline measurement.||Percentage of participants|||Number
762684|NCT00654628|Primary|The Percentage of Participants Achieving Low Density Lipoprotein-C (LDL-C) Treatment Goal After 6-week Treatment.|Goal attainment percentage of LDL-C after 6-week treatment. LDL-C goal attainment was based on National Cholesterol Education program (NCEP) Adult Treatment Panel (ATP) III guidelines (2004). Newly Diagnosed Dyslipidemia Patients Including: 1)Intermediate Risk (>2 Risk Factors) with Total Cholesterol above 200 mg/dL or Low Density Lipoprotein C (LDL-C) level >130 who failed a 3-month diet control period, or 2) high risk patients with a history of coronary artery disease or diabetes having a total cholesterol >200 mg/dl or LDL-C level >130 mg/dl.|Baseline and week 6|Intention-To-Treat (ITT) approach which included all participants who have baseline measurement, have taken at least one dose of the study drug, and have at least one post-baseline measurement.||Percentage of participants|||Number
762685|NCT00654641|Primary|Total Number of Patients Experiencing a Wound Complication|Superficial or deep space surgical site infection, or any type of wound disruption, including wound hematoma or seroma.|6 Weeks post-partum|||Participants|||Number
762686|NCT00654654|Primary|Independent Panel Global Improvement Assessment Compared to Baseline|An independent panel of physicians reviewed photographs of subjects at baseline and 6 months after final study treatment and provided a score for improvement in appearance on the Global Improvement Assessment. The Global Improvement Assessment was a four point ordinal scale with 0 (No improvement) as the worst score and 3 (Marked Improvement) the best.|Baseline (prior to treatment) compared to 6 months post last treatment|Number of patients for whom data were available||participants|||Number
762687|NCT00654654|Primary|Change in Subject Assessment of Wrinkles Compared to Baseline on Subject Wrinkle Assessment|Subject Wrinkle Assessment was a five point ordinal scale that assessed the subject's assessment of the appearance of their face. A score of -2 (very dissatisfied) was the worst and a score of +2 (very satisfied) was the best.|Baseline (prior to first treatment) compared to 6 months post last treatment|Number of subjects for whom data were available from the assessment visit, 6 months after the final treatment||participants|||Number
762688|NCT00654745|Secondary|Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 18|number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 18|week 0 - week 18|||participants|||Number
762689|NCT00654745|Secondary|Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 15|number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 15|week 0 - week 15|||participants|||Number
762690|NCT00654745|Secondary|Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 12|number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 12|week 0 - week 12|||participants|||Number
762691|NCT00654745|Secondary|Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 9|number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 9|week 0 - week 9|||participants|||Number
762692|NCT00654745|Secondary|Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 6|number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 6|week 0 - week 6|||participants|||Number
762693|NCT00654745|Secondary|Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 3|number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 3|week 0 - week 3|||participants|||Number
762694|NCT00654745|Secondary|Number of Participants Achieving Mean Last 2 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12|number of participants achieving mean last 2 hour ambulatory systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 12|week 0 - week 12|||participants|||Number
762695|NCT00654745|Secondary|Number of Participants Achieving Mean Last 4 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions|number of participants achieving mean last 4 hour ambulatory systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 12|week 0 - week 12|||participants|||Number
762696|NCT00654745|Secondary|Number of Participants Achieving Mean Last 6 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12|number of participants achieving mean last 6 hour ambulatory systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 12|week 0 - week 12|||participants|||Number
762715|NCT00654745|Secondary|Change From Week 0 (Baseline) in Mean ABPM Diastolic Blood Pressure (DBP) After 12 Weeks of Active Treatment|24-hour mean DBP, Daytime mean DBP, Nighttime mean DBP, Last 6 hour mean DBP, Last 4 hour mean DBP, Last 2 hour mean DBP|week 0 - week 12 (24-hour, Daytime, Nighttime, Last 6 hour, Last 4 hour, Last 2 hour)|||mm Hg||Standard Error|Mean
762697|NCT00654745|Secondary|Number of Participants Achieving Mean Nighttime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12|number of participants achieving mean nighttime ambulatory systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 12|week 0 - week 12|||participants|||Number
762698|NCT00654745|Secondary|Number of Participants Achieving Mean Daytime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12|number of participants achieving mean daytime ambulatory systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 12|week 0 - week 12|||participants|||Number
762699|NCT00654745|Secondary|Number of Participants Achieving Mean 24 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12|number of participants achieving mean 24 hour ambulatory systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 12|week 0 - week 12|||participants|||Number
762700|NCT00654745|Secondary|Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 18|number of participants achieving seated systolic and diastolic blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 18|week 0 - week 18|||participants|||Number
762701|NCT00654745|Secondary|Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 15|number of participants achieving seated systolic and diastolic blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 15|week 0 - week 15|||participants|||Number
762702|NCT00654745|Secondary|Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 12|number of participants achieving seated systolic and diastolic blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 12|week 0 - week 12|||participants|||Number
762703|NCT00654745|Secondary|Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 9|number of participants achieving seated systolic and diastolic blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 9|week 0 - week 9|||participants|||Number
762704|NCT00654745|Secondary|Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 6|number of participants achieving seated systolic and diastolic blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 6|week 0 - week 6|||participants|||Number
762705|NCT00654745|Secondary|Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 3|number of participants achieving seated systolic and diastolic blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 3|week 0 - week 3|||participants|||Number
762706|NCT00654745|Secondary|Number of Participants Achieving Mean Last 2 Hour Ambulatory Blood Pressure Thresholds at Week 12|number of participants achieving mean last 2 hour ambulatory blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 12|week 0 - week 12|||participants|||Number
762707|NCT00654745|Secondary|Number of Participants Achieving Mean Last 4 Hour Ambulatory Blood Pressure Thresholds at Week 12|number of participants achieving mean last 4 hour ambulatory blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 12|week 0 - week 12|||participants|||Number
762708|NCT00654745|Secondary|Number of Participants Achieving Mean Last 6 Hour Ambulatory Blood Pressure Thresholds at Week 12|number participants achieving mean last 6 hour ambulatory blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 12|week 0 - week 12|||participants|||Number
762709|NCT00654745|Secondary|Number of Participants Achieving Mean Nighttime Ambulatory Blood Pressure Thresholds at Week 12|number of participants achieving mean nighttime ambulatory blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, BP<120/70, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75, DBP<70 at week 12|week 0 - week 12|||participants|||Number
762710|NCT00654745|Secondary|Number of Participants Achieving Mean Daytime Ambulatory Blood Pressure Thresholds at Week 12|number of participants achieving mean daytime ambulatory blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 12|week 0 - week 12|||participants|||Number
762711|NCT00654745|Secondary|Number of Participants Achieving Mean 24-hour Ambulatory Blood Pressure Thresholds at Week 12|number of participants achieving mean 24-hour ambulatory blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 12|week 0 - week 12|||participants|||Number
762712|NCT00654745|Secondary|Change in Mean Seated Diastolic Blood Pressure (SeDBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks|change in mean SeDBP from week 0 (baseline) to Weeks 3, 6, 9, 12, 15, and 18.|week 0 - weeks 3, 6, 9, 12, 15, 18|Number of participants changed by week. Week 3 = 201, Week 6 = 192, week 9 = 184, week 12 = 177, week 15 = 172, week 18 = 164.||mm Hg||Standard Error|Mean
762713|NCT00654745|Secondary|Change in Mean Seated Systolic Blood Pressure (SeSBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks|change in mean SeSBP from week 0 (baseline) to Weeks 3, 6, 9, 12, 15, and 18.|week 0 - weeks 3, 6, 9, 12, 15, 18|Number of participants changed by week. Week 3 = 201, Week 6 = 192, week 9 = 184, week 12 = 177, week 15 = 172, week 18 = 164.||mm Hg||Standard Error|Mean
762714|NCT00654745|Secondary|Change From Week 0 (Baseline) in Mean ABPM SBP After 12 Weeks of Active Treatment|Daytime mean SBP, Nighttime mean SBP, Last 6 hour mean SBP, Last 4 hour mean SBP, Last 2 hour mean SBP|week 0 - week 12 (24-hour, Daytime, Nighttime, Last 6 hour, Last 4 hour, Last 2 hour)|||mm Hg||Standard Error|Mean
767744|NCT00697593|Primary|Hematology - Red Blood Cell Count|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 3 participants missing values||x10^12/L||Standard Deviation|Mean
762716|NCT00654745|Primary|Change From Week 0 (Baseline) in Mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (SBP) After 12 Weeks of Active Treatment|Change from week 0 (baseline) in mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (SBP) after 12 weeks of active treatment. change = week 12 - week 0.|week 0 - week 12|ABPM subjects analysis population included 165 subjects who received at least one dose of active study medication and provided valid ambulatory blood pressure monitoring measurements at baseline and week 12.||mm Hg||Standard Error|Mean
762717|NCT00654784|Secondary|Safety and Tolerability, Assessed by Adverse Events, Blood and Urine Laboratory Measures, ECG.||1 year||||||
762718|NCT00654784|Secondary|Skeletal Muscle Strength (Upper Limb, Right and Left): Hand Grip, Elbow Flexors and Elbow Extensors (Upper Limb Score) Timed Walking Test (10 Metres) (Ambulant Patients Only)||1 year||||||
762719|NCT00654784|Secondary|Respiratory Function: Forced Vital Capacity (FVC), Forced Expiratory Volume in 1 Second (FEV1), Maximal Inspiratory Pressure (MIP) and Peak Flow (PF)||1 year||||||
762720|NCT00654784|Primary|The Relative Change in Peak Systolic Radial Strain of the Left Ventricle (LV) Inferolateral Wall From Baseline (at Screening) to Week 52, Assessed by Color Doppler Myocardial Imaging (CDMI).|"Assessing the peak systolic radial strain of the left ventricle inferolateral wall is used to characterize the cardiac involvement in the DMD patients.
Color Doppler Myocardial Imaging technique is used to quantify regional myocardial function.
The cardiac involvement in DMD is characterized by degeneration, atrophy and fibrosis of the myocardium, leading to dilated cardiomyopathy. The process begins in the posterolateral wall of the left ventricle, with septal involvement appearing at later stages."|baseline and Week 52|At Week 52, data from only 18 patients were available for the primary endpoint analysis due to missing data from 2 patients and the inability to acquire data from a 3rd patient. The efficacy comparison for the primary endpoint was conducted using the LOCF method in the ITT population. In addition, the analysis was repeated using the OC dataset.||% change in peak systolic||Standard Deviation|Mean
762721|NCT00648895|Primary|Percentage Change From Baseline to End of Treatment for the Difference Between the Post-ischemia and Pre-ischemia Forearm Vascular Resistance (FVR).|Pre-and post-ischemia forearm vascular resistance (FVR), calculated by forearm blood flow (FBF) and systolic blood pressure (SBP), and assessed at the trough/pre-meal time point (used for percentage change analysis between baseline and postbaseline). Measurements occured at baseline (visit 5) and end of treatment (week 10).|Before treatment and after 10 weeks|Due to the small sample size, no efficacy conclusion could be made. 0 measured value primary outcome =Not applicable.||Percentage||Standard Deviation|Mean
762722|NCT00648908|Secondary|Expanded Disability Status Scale (EDSS)|"Each patient, based on their baseline neurological exam, are scored according to the EDSS
The EDSS was used to grade patient disability on a scale from 0.0 (normal neurological exam) to 10.0 (death) at the Screening Visit, Visit 6, and Final Visit or Early Termination Visit if applicable."|Screening visit, visit 6 and every 24 months thereafter|ITT Population. No imputation for missing data||units on a scale||Standard Deviation|Mean
762723|NCT00648908|Secondary|Clinician Global Impression of Change (CGIC)|"Investigator's overall impression of the patients neurological status and general state of health related to his/her participation in the study; specifically signs and symptoms associated with MS.
The potential responses were 1=very much improved, 2=much improved, 3=somewhat improved, 4=no change, 5=somewhat worse, 6=much worse, and 7=very much worse."|visit 1 and every clinic visit|ITT Population. No imputation for missing data||units on a scale||Standard Deviation|Mean
762724|NCT00648908|Secondary|Subject Global Impression (SGI)|"Patients asked to complete a Subject Impression questionnaire rating his/her impression of the effects of study drug during the preceding week, specifically in regards to signs and symptoms associated with Multiple Sclerosis (MS).
For the SGI, the potential responses to the effects of the investigational drug during the preceding week were 1=terrible, 2=unhappy, 3=mostly dissatisfied, 4=neutral/ mixed, 5=mostly satisfied, 6=pleased, and 7=delighted."|visit 1 and every clinic visit|ITT Population. No imputation for missing data||units on a scale||Standard Deviation|Mean
762725|NCT00648908|Secondary|Timed 25 Foot Walk (T25FW)||Week 2, 14, 26, continuing every 26 weeks until the Final Visit|ITT Population. No imputation for missing data||feet/second||Standard Deviation|Mean
762726|NCT00648908|Primary|Summary of Treatment Emergent Adverse Events (TEAE).|All adverse events reported were treatment emergent. Therefore, events that had a date of onset, or worsening, on or after the start of the open-label drug and up to 14 days after the last dose (for non-serious events) or up to 30 days after the last dose (for SAEs) were summarized. Any abnormal clinically significant changes in physical examination, medical history, clinical laboratory testing, 12-lead ECG, and standard EEG testing were captured as adverse events.|up to 5 years|Safety Population. No imputation for missing data||Participants|||Number
762727|NCT00649220|Secondary|Change in the VAS Score From Baseline to Week 8, 12, 16 and/or 20.|"VAS is a report device to measure the subject’s burden caused by behavioral symptoms. To measure the burden on the VAS only the first 3 items of the Neuropsychiatric Inventory (NPI) Questionnaire were considered (delusions, hallucinations (visual and auditory), and agitation / aggression). The VAS consists of a 100 mm horizontal line, anchored at the ends with the reference “not at all” and “extremely. The VAS score was determined by measuring in mm from the left hand end of the line to the point, where the investigator had marked the magnitude of a subject’s burden."|Week 8-20 post Baseline|"Intention to treat (ITT).
Week 8: n=17; Week 12: n=16; Week 16: n=16; Week 20: n=18"||Units on a scale [cm]||Standard Deviation|Mean
762728|NCT00649220|Secondary|Change of Nurses’ Observation Scale for Geriatric Patients [NOSGER] Total Score Value From Baseline to Week 4, 8, 12, 16, and/or 20|"NOSGER is a comprehensive scale, which contains 30 items of behavior, each rated on a 5-point scale according to the frequency of occurrence by direct observation. Item scores are summarized into 6 dimension scores: memory, instrumental activities of daily life, self-care, mood, social behavior, and disturbing behavior. The NOSGER has a scoring range of 30 to 150 with the higher scores indicating worse subject’s status. The items in each group are rated for their frequency ranging from 1 (never) to 5 (always).
A change of <0 reveals an improvement compared to baseline."|Week 4-20 post Baseline|"Intention to treat (ITT).
Week 4: n=18; Week 8: n=17; Week 12: n=16; Week 16: n=16; Week 20: n=17"||Units on a scale||Standard Deviation|Mean
762816|NCT00658385|Primary|Number of Participants With no Serious Adverse Events|The entered value represents the number of participants with the absence of serious adverse events. G-CSF mobilization will be considered safe if there are no more than 1 of 5 patients with SAEs|Up to 14 Days|||participants|||Number
762729|NCT00649220|Secondary|Change of Modified Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADLB19) Score Value From Baseline to Week 4, 8, 12, 16, and/or 20.|"The modified ADCS-ADL19 is comprehensive battery of ADL questions aimed to measure the functional ability of subjects with Dementia of Alzheimer’s type over a broad range of dementia severity. It has a scoring range of 0 to 54 with the lower scores indicating greater functional impairment. Each ADL item was rated from the highest level of independent performance to complete loss.
Change of >0 reveals an improvement compared to baseline."|Week 4-20 post Baseline|"Intention to treat (ITT).
Week 4: n=18; Week 8: n=17; Week 12: n=16; Week 16: n=16; Week 20: n=18"||Units on a Scale||Standard Deviation|Mean
762730|NCT00649220|Secondary|"Change of Test for the Early Detection of Dementia With Discrimination From Depression [TE4D] Score Value From Baseline to Week 4, 8, 12, 16, and/or 20 - Second Part: Total Depression"|"TE4D is a psychometric, physician-administered test that is used for both screening subjects with early dementia and monitoring the clinical progress of the disease. The second part consists of a proxy rating and a self-assessment rating. The scoring range of each rating is 1 to 10. The maximum total score of 10 corresponds to severe depression.
A change <0 reveals an improvement compared to baseline."|Week 4-20 post Baseline|"Intention to treat (ITT).
Week 4: n=18; Week 8: n=17; Week 12: n=16; Week 16: n=16; Week 20: n=17"||units on a scale||Standard Deviation|Mean
762731|NCT00649220|Secondary|"Change of Test for the Early Detection of Dementia With Discrimination From Depression [TE4D] Score Value From Baseline to Week 4, 8, 12, 16, and/or 20 - First Part: Total Dementia"|"TE4D is a psychometric, physician-administered test that is used for both screening subjects with early dementia and monitoring the clinical progress of the disease. The first part consists of 9 items, which assess different symptoms associated with dementia such as memory, time-orientation, etc. The scoring range is 0 to 50 points. A score of 35 or lower is an indication of dementia.
A change >0 represents an improvement."|Week 4-20 post baseline|"Intent to treat (ITT).
Week 4: n=18; Week 8: n=17; Week 12: n=16; Week 16: n=16; Week 20: n=17"||units on a scale||Standard Deviation|Mean
762732|NCT00649220|Secondary|Change in the Mini-Mental State Examination (MMSE) Score Value From Baseline to Week 20.|MMSE is a brief, physician–administered scale, designed for measuring the cognitive functions, such as: orientation, memory, attention, naming, and comprehension. The scoring range of MMSE is 0 to 30 points. A score of 23 or lower is indicative of cognitive impairment. Change of >0 reveals an improvement compared to baseline.|Week 20 post baseline|Intention to treat (ITT)||units on a scale||Standard Deviation|Mean
762733|NCT00649220|Secondary|Reduction of Antipsychotic Drug Dose From Baseline to Week 8, 12, 16 and/or 20.|See #1 and #8. Change of <0 reveals a reduction of AP compared to baseline.|Week 8-20 post Baseline|"Intention to treat (ITT).
Week 8: n=16; Week 12: n=14; Week 16: n=13; Week 20: n=15"||Percent of daily dose [DDD]||Standard Deviation|Mean
762734|NCT00649220|Primary|Maximum Dose Reduction of Antipsychotics (AP) in Percent of Defined Daily Dose (DDD) From Baseline to a Post-baseline Visit at Which the Value of the Visual Analogue Scale (VAS) Compared With the Baseline Value Was =< 15 Percent.|VAS: see #8. Mean “percent of the total Defined Daily Dose (DDD)”, averaged over one week, was calculated. Total DDD was calculated as sum of DDD for each AP drug. DDD is the assumed average maintenance dose per day defined by WHO. The reduction of AP Δ [percent] was calculated as a difference between the mean total DDD recorded at baseline and the mean total DDD recorded at the respective week. Measurements from those post-baseline visits were taken into account only when the value of the VAS was not substantially worse compared to baseline.|Week 8-20 post baseline|Intention to treat (ITT)||Percent of daily dose [DDD]||Standard Deviation|Mean
762735|NCT00654836|Secondary|Overall Survival|Overall survival was measured from treatment initiation to 80 months|80 Months|All enrolled participants are included in this analysis||Months||95% Confidence Interval|Median
762736|NCT00654836|Secondary|Response Rate at End of Treatment|Response to treatment was recorded 30 months following treatment initiation. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progressive Disease (PD); PD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions .|30 Months|Of the 32 enrolled participants, two participants did not return to the clinic at 30 months for final evaluation of their response to treatment.||participants|||Number
762737|NCT00654836|Primary|Progression-free Survival|Progression-free survival was measured from treatment initiation to 30 months. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|30 Months|All enrolled participants are included in this analysis||Months||95% Confidence Interval|Median
762738|NCT00654875|Secondary|Percentage of Participants Achieving Blood Pressure Control at the End of the Study (Week 10)|"After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using a calibrated standard sphygmomanometer. The mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure at visit 4 (week 10).
Blood pressure control was defined as having a mean sitting diastolic blood pressure (msDBP) <90 mm Hg and a mean sitting systolic blood pressure (msSBP) <140 mm Hg."|Week 10|Participants from the Full analysis set (consisting of all randomized patients) for whom data was available at Week 10.||Percentage of participants|||Number
762739|NCT00654875|Secondary|Percentage of Participants Achieving Blood Pressure Control at Week 6|"After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using a calibrated standard sphygmomanometer. The mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure at visit 3 (week 6).
Blood pressure control was defined as having a mean sitting diastolic blood pressure (msDBP) <90 mm Hg and a mean sitting systolic blood pressure (msSBP) <140 mm Hg."|Week 6|Participants from the Full analysis set (consisting of all randomized patients) for whom data was available at Week 6.||Percentage of participants|||Number
762817|NCT00658411|Secondary|1-year Post-Transplant Survival|Survival information for the 5 patients who were treated with deferoxamine was collected. This information was used to determine transplant-related mortality, relapse, disease-free and overall survival.|1 year|Stopped early for poor accrual||participants|||Number
762740|NCT00654875|Secondary|Change From Baseline to Week 6 in the Mean Sitting Systolic and Mean Sitting Diastolic Blood Pressure|After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using a calibrated standard sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. A negative number indicates lowered blood pressure. The ANCOVA model used baseline as a covariate.|Baseline, Week 6|Participants from the Full analysis set (consisting of all randomized patients) for whom data was available at Baseline and Week 6.||mm Hg||Standard Error|Least Squares Mean
762741|NCT00654875|Secondary|Change From Baseline to Week 6 in the Mean 24-hour Ambulatory Systolic Blood Pressure (MASBP)|An Ambulatory Blood Pressure Monitoring (ABPM) device was attached to the non-dominant arm of the participant. The mean of Blood Pressure readings during the 24 hour period were calculated. The difference of the 24 hour MASBP from baseline to the 24 hour MASBP at 6 weeks was calculated using an ANCOVA model with baseline mean 24 hour ambulatory systolic blood pressure as a covariate.|Baseline, Week 6|Participants from the Full analysis set (consisting of all randomized patients) for whom data was available at Baseline and Week 6.||mm Hg||Standard Error|Least Squares Mean
762742|NCT00654875|Secondary|Change From Baseline to Week 6 in the Mean Ambulatory Systolic Blood Pressure (MASBP) During the Last Three Hours of the 24-hour Dosing Period|An Ambulatory Blood Pressure Monitoring (ABPM) device was attached to the non-dominant arm of the participant. The mean of Blood Pressure readings during the 22-24 hour period were calculated. The difference from the last 3 hours MASBP at baseline to the last 3 hour MASBP at Week 6 was calculated using an ANCOVA model with baseline mean 24 hour ambulatory systolic blood pressure as a covariate.|Baseline, Week 6|Participants from the Full analysis set (consisting of all randomized patients) for whom data was available at Baseline and Week 6.||mm Hg||Standard Error|Least Squares Mean
762743|NCT00654875|Secondary|Change From Baseline to Week 6 in the Mean Ambulatory Diastolic Blood Pressure (MADBP) During the Last 3 Hours of the 24-hour Dosing Period|An Ambulatory Blood Pressure Monitoring (ABPM) device was attached to the non-dominant arm of the participant. The mean of Blood Pressure readings during the 22-24 hour period were calculated. The difference from the last 3 hours MADBP at baseline to the last 3 hour MADBP at Week 6 was calculated using an ANCOVA model with baseline mean 24 hour ambulatory diastolic blood pressure as a covariate.|Baseline, Week 6|Participants from the Full analysis set (consisting of all randomized patients) for whom data was available at Baseline and Week 6.||mm Hg||Standard Error|Least Squares Mean
762744|NCT00654875|Primary|Change From Baseline to Week 6 in the Mean 24-hour Ambulatory Diastolic Blood Pressure (MADBP)|An Ambulatory Blood Pressure Monitoring (ABPM) device was attached to the non-dominant arm of the participant. The mean of Blood Pressure readings during the 24 hour period were calculated. The difference of the 24 hour MADBP from baseline to the 24 hour MADBP at 6 weeks was calculated using an Analysis of covariance (ANCOVA) model with baseline mean 24 hour ambulatory diastolic blood pressure as a covariate.|Baseline, Week 6|Participants from the Full analysis set (consisting of all randomized patients) for whom data was available at Baseline and Week 6.||mm Hg||Standard Error|Least Squares Mean
762745|NCT00654901|Primary|Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine|"Solicited Injection Site Reactions: Pain, Erythema, Swelling, Extensive Swelling of Vaccinated Limb. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability.
Grade 3 reactions were defined as: Pain, cries when injected limb is moved or movement of injected limb reduced; Erythema and swelling, ≥ 5cm; Extensive swelling of limb; Pyrexia, ≥ 39.6ºC; Vomiting ≥ 6 episodes/24 hours or requiring parenteral hydration; Somnolence, sleeping most of time or difficult to wake up; Anorexia, refuses ≥ feeds or most feeds; Irritability, inconsolable."|Days 0 up to 7 after any injection|Solicited reactions were assessed in all subjects who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population).||Participants|||Number
762746|NCT00654901|Primary|Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine|"Antibody persistence and immunogenicity response:
Level 1: ≥ 10 mIU/mL for hepatitis B (Hep B), ≥ 0.15 µg/mL for Haemophilus influenzae type b (PRP), and ≥ 0.01 IU/mL for diphtheria (D) and tetanus (T). Level 2: ≥ 100 mIU/mL (Hep B), ≥ 1.0 µg/mL (PRP), and ≥ 0.1 IU/mL (D and T) Level 3, ≥ 1.0 IU/mL (D and T). Anti-polio titers were defined as ≥ 8 (1.dil), and pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by a 4 fold increase from Day 0."|Day 0 (pre-booster) and Day 30 (one month post-booster)|Antibody persistence and immunogenicity response were assessed in all participants with endpoint data who did not have any protocol deviation that might have interfered with primary criteria evaluation (Per Protocol Population).||Participants|||Number
762747|NCT00654901|Primary|Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T|Antibody titers were measured for hepatitis B (Hep B) by enhanced chemiluminescence detection, for Haemophilus influenzae type b (PRP) by Farr type radioimmunoassay, for diphtheria by toxin neutralization test, and for tetanus by enzyme linked immunosorbent assay (ELISA). Antibody titers were measured for poliovirus types 1, 2, and 3 by neutralization assay. Antibody titers were measured for pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by ELISA.|Day 0 (pre-booster) and Day 30 (one month post-booster)|Geometric mean titers were assessed in a subset of participants with endpoint data who did not have any protocol deviation that might have interfered with primary criteria evaluation (Per-Protocol Population).||Titers||95% Confidence Interval|Geometric Mean
762748|NCT00654927|Secondary|Expanded Disability Status Scale (EDSS)|"Based on the baseline neurological exam, each patient was scored according to the Expanded Disability Status Scale, which rates disability on a 0 to 10 scale (0 = normal neurologic examination, 10 = death)
*EDSS assessments were not well synchronized to study period because of wide differences in interval between screening and initiation"|Screening visit, visit 6 and every 24 months thereafter|ITT Population. No imputation for data missing||units on a scale||Standard Deviation|Mean
762749|NCT00654927|Secondary|Clinician Global Impression of Change (CGIC)|The CGIC was based on the Investigator’s overall impression of the patient’s neurological status and general state of health related to his or her participation in the study, specifically in regard to signs and symptoms associated with MS. Neurological status was rated according to a 1 to 7 point scale (1 = very much improved, 7 = very much worse)|visit 1 and every clinic visit|ITT Population. No imputation for missing data||units on a scale||Standard Deviation|Median
762750|NCT00654927|Secondary|Subject Global Impression (SGI)|The patient was asked to complete a Subject Global Impression (SGI) questionnaire at Visit 1 and every study visit thereafter except the Follow-up visit. This questionnaire asked the patient to rate the effects of the investigational drug on his/her physical well-being during the preceding week, using a 1 to 7 point scale (1 = terrible, 7 = delighted)|visit 1 and every clinic visit|ITT Population. No imputation for missing data||units on a scale||Standard Deviation|Mean
762751|NCT00654927|Secondary|Timed 25 Foot Walk (T25FW)||Screening visit, visit 4, every 12 weeks thereafter, Last Regular Visit, Follow Up Visit and Early Termination Visit|ITT Population. No imputation for missing data||feet/second||Standard Deviation|Mean
762752|NCT00654927|Primary|Summary of Treatment Emergent Adverse Events (TEAE).|All adverse events reported were treatment emergent. Therefore, events that had a date of onset, or worsening, on or after the start of the open-label drug and up to 14 days after the last dose (for non-serious events) or up to 30 days after the last dose (for SAEs) were summarized. Any abnormal clinically significant changes in physical examination, medical history, clinical laboratory testing, 12-lead ECG, and standard EEG testing were captured as adverse events.|over 7 years (2004-2011)|Safety Population. No imputation for missing data||participants|||Number
762753|NCT00654940|Secondary|Subject Activity as Captured by the Actiwatch Score Device: Total Activity Score at End of Treatment|Total activity score: Day (8 am to 8 pm) at end of treatment. Accelerometer measured physical activity by monitoring degree and intensity of body motion. Data is reported as activity counts. Subject activity was collected hourly for the variables: peak, average, and total activity. Higher score indicates greater activity (no activity = 0; total possible score was not defined).|Week 0 to Week 2, Week 4 to Week 6 (Baseline to End of Treatment in Treatment Periods 1 and 2)|FAS; End of Treatment is treatment week 2 (Week 2 and Week 6) for Periods 1 and 2.||scores on scale||Standard Error|Least Squares Mean
762754|NCT00654940|Secondary|Neuropathic Pain Symptom Inventory (NPSI)|NPSI at end of treatment: 10-item self-administered questionnaire assessing 5 dimensions of pain (burning superficial spontaneous pain, pressing deep spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dysesthesia). Each item consists of a question about the specific qualities of pain and an 11-point numerical scale range: 0 (absence of pain) to 10 (maximum intensity imaginable), and 2 temporal items related to spontaneous and paroxysmal pain. Maximum total score possible = 100.|Week 0 to Week 2, Week 4 to Week 6 (Baseline to End of Treatment in Treatment Periods 1 and 2)|FAS. Weeks 0 and 4 are baseline for Periods 1 and 2, respectively. Weeks 2 and 6 are End of Treatment for Periods 1 and 2, respectively.||scores on scale||Standard Deviation|Mean
762755|NCT00654940|Primary|Change From Baseline to Treatment Week 2 in Daily Pain Rating Scale|Daily Pain Rating Scale by treatment and sequence using an 11-point Likert scale: range 0 (no pain) to 10 (worst possible pain) over the past 24 hours. Self-assessment was performed daily on rising from bed (for the final time in the case of interrupted sleep). Average daily pain score: mean of the previous 7 days daily pain scores. Baseline was defined as the mean of the last 7 pre-treatment pain scores for each period. End of treatment was defined as the mean of the last 7 on treatment pain scores for each period.|Week 0 to Week 2, Week 4 to Week 6 (Baseline to Week 2 [End of Treatment] for each treatment period)|Full Analysis Set: (FAS): all subjects randomized who received at least one dose of study drug, regardless of whether they had efficacy data. Baseline is Week 0 and Week 4 for Periods 1 and 2, respectively. Treatment Week 2 is End of Treatment (Week 2 and Week 6) for Periods 1 and 2, respectively.||scores on scale||Standard Deviation|Mean
762756|NCT00654953|Primary|Urine Toxicology Screens for the Presence of Cocaine/Cocaine Metabolites|Thrice-weekly urine samples were analyzed for the presence of cocaine/cocaine metabolite. Days to Relapse was defined as time to the second of two urine results consecutively positive for cocaine.|70 days|Participants who completed the two-week residential stay and had 2 urine samples consecutively positive for cocaine were included in the analysis.||Days to relapse (two consec coc+ urines)|Participants|Standard Deviation|Mean
762757|NCT00654992|Primary|Number of Participants Who Had AKI (Acute Kidney Injury)|number of participants who had 50% increase in serum creatinine levels from baseline|at any time within the first 5 days after surgery|||participants|||Number
762758|NCT00654992|Secondary|Change in Estimated Glomerular Filtration Rate (eGFR)|estimated glomerular filtration rate (eGFR)as ml/min/1.73m2|during the first 5 days after surgery|||ml/min/1.73m2||Standard Deviation|Mean
762759|NCT00655083|Secondary|Number of Adverse Events After Administration of Single Oral Doses up to 0.5 mg/kg of Nepadutant in Infants.|Number of adverse events (AE) reported by dose and age stratum 18-24 weeks.|one week|Number of adverse events by dose and age stratum (18-24 weeks of age) are reported by system organ class and preferred term.||Adverse Events|||Number
762760|NCT00655083|Primary|Drug Concentration Measurement in the Urine Collected by Diapers Along 24 Hours Post Dose and One Week After Dose in All Treated Infants and by Age and Dose Subgroups.|Nepadutant was measured in the 24-h urine collection post both doses (0.1 and 0.5 mg/kg dose), in the age stratum 18-24 weeks, using urinary collection/extraction from pre-weighed special fiber based diapers.|24 hours|Urinary drug concentration was analysed by dose and age stratum of the infants (18-24 weeks of age). Imputation technique was adopted for urine samples highly contaminated by faeces.||ng||Standard Deviation|Mean
762761|NCT00655083|Secondary|Number of Adverse Events After Administration of Single Oral Doses up to 0.5 mg/kg of Nepadutant in Infants.|Number of adverse events (AE) reported by dose and age stratum 6-<12 and 12-<18 weeks.|one week|Number of adverse events by dose and age strata (6-<12 and 12- <18 weeks of age) are reported by system organ class and preferred term.||Adverse Events|||Number
762762|NCT00655083|Primary|Drug Concentration Measurement in the Urine Collected by Diapers Along 24 Hours Post Dose and One Week After Dose in All Treated Infants and by Age and Dose Subgroups.|Nepadutant was measured in the 24-h urine collection post both doses (0.1 and 0.5 mg/kg dose), in the age strata 6-<12 and 12-<18 weeks, using urinary collection/extraction from pre-weighed special fiber based diapers.|24 hours|Urinary drug concentration was analysed by dose and age stratum of the infants (6-<12 and 12- <18 weeks of age). Imputation technique was adopted for urine samples highly contaminated by faeces.||ng||Standard Deviation|Mean
762787|NCT00657657|Secondary|Number of Subjects Reporting Unsolicited Adverse Events|An adverse event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|During the 31-day follow-up period after the challenge dose of hepatitis B vaccine|||subjects|||Number
762763|NCT00657267|Secondary|Time to Progression.|Progression is defined using Modified Macdonald Criteria , using a >/= 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR clear clinical worsening or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).|From patient registration until end of study, assessed up to 54 months|Of the 58 patients registered, 3 of were ineligible for analysis based on path review, which is why only 55 patients were evaluated for this outcome.||days||95% Confidence Interval|Median
762764|NCT00657267|Secondary|Radiographic Response|Responders on study are those with a best response of either CR or PR. Per Modified Macdonald Criteria for lesions assessed by MRI/CT: Complete Response (CR) = Complete disappearance of all measurable and evaluable disease, no new lesions, no evidence of non-evaluable disease, with no steroids. Partial Response (PR) >/= 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions, no progression of evaluable disease, no new lesions, with steroid dose @ time of response </= max dose w/in the first 8 weeks of therapy.|From patient registration until end of study, assessed up to 54 months|Of the 58 patients registered, 3 of were ineligible for analysis based on path review, which is why only 55 patients were evaluated for this outcome.||percentage of participants evaluated|||Number
762765|NCT00657267|Secondary|Overall Survival||From patient registration until end of study, assessed up to 54 months|Entire study population||months||95% Confidence Interval|Median
762766|NCT00657267|Primary|6 Month Progression Free Survival|Progression is defined using Modified Macdonald Criteria , using a >/= 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR clear clinical worsening or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).|6 months|Patients evaluable for imaging analysis, as protocol-defined.||percentage of evaluable participants|||Number
762767|NCT00657280|Secondary|Determine the Effects of Sitagliptin on Microvascular Function in Patients With Nonischemic Cardiomyopathy|This study will investigate the effects of sitagliptin, a medicine commonly used to treat type 2 diabetes, on the utilization of glucose by the heart in patients with heart failure which is not due to heart attacks. We hope to determine whether improving the heart's ability to use glucose in the blood may help improve the function of the heart as well. If so, this may suggest that even people who do not have frank diabetes but who do have heart failure may benefit from using this medication.|4 years||||||
762768|NCT00657280|Secondary|Determine the Effects of Sitagliptin on Microvascular Function in Patients With Nonischemic Cardiomyopathy||2010-2012||||||
762769|NCT00657280|Primary|Determine the Effects of Sitagliptin on Myocardial Glucose Uptake in Patients With Nonischemic Cardiomyopathy|This study will investigate the effects of sitagliptin, a medicine commonly used to treat type 2 diabetes, on the utilization of glucose by the heart in patients with heart failure which is not due to heart attacks. We hope to determine whether improving the heart's ability to use glucose in the blood may help improve the function of the heart as well. If so, this may suggest that even people who do not have frank diabetes but who do have heart failure may benefit from using this medication.|2008-2012||||||
762770|NCT00657280|Primary|Determine the Effects of Sitagliptin on Myocardial Glucose Uptake Measured by Myocardial PET Scan|This study will investigate the effects of sitagliptin, a medicine commonly used to treat type 2 diabetes, on the utilization of glucose by the heart in patients with heart failure which is not due to heart attacks. We hope to determine whether improving the heart's ability to use glucose in the blood may help improve the function of the heart as well. If so, this may suggest that even people who do not have frank diabetes but who do have heart failure may benefit from using this medication. Baseline glucose uptake scans will be compared with the scans on sitagliptin thirty days after baseline|30 days|Scans were lost in 4 participants||SUV||Full Range|Mean
762771|NCT00657358|Primary|Tactile Sensation|Pin prick sensory thresholds (PPT) were obtained by touching the skin in-between the first and second metacarpal bone with a 23-gauge needles which moved freely out of a 10 mL plastic syringe barrel. The pin prick sensation was modified by adding small weights to the 23-gauge needles (from 0.2 to 5.2 mg). A syringe barrel of tuberculin (TB) needles that were cut to different lengths to add the desired weight to the 23-gauge needle. The PPT was determined using the weighted 23-gauge needle in ascending order, according to the method of limits. This assessment was to evaluate whether participants were able to feel the touch of the needle. The participant’s arm was placed on a tray table. A linen sheet was suspended in-between two IV poles in such a fashion that the subject’s view of his/her hand was blocked. Normal values are between 0.21mg and 5mg.|baseline, during 20 minute infusion, and 30 minutes after completion of infusion|||weight in mg||Standard Error|Mean
762772|NCT00657358|Primary|Cold Pain|The participant’s foot was immersed up to the ankle into a container filled with ice water of 3°C. Participants were instructed to maintain their foot in the container until the cold pain became intolerable (cold pain tolerance). The length of time was recorded in seconds. This procedure was repeated once with a gap of at least fifteen minutes in-between repeated tests. The range was 0 seconds to 120 seconds|baseline, during 20 minute infusion, and 30 minutes after lidocaine infusion|||time in seconds to withdrawal||Standard Error|Mean
762773|NCT00657358|Primary|Heat Pain|The thermal procedure involved a baseline assessment of heat pain threshold and tolerance. Contact heat stimuli were delivered using a computer-controlled Medoc Thermal Sensory Analyzer (TSA-II; Ramat Yishai, Israel), which is a peltier elementbased stimulator. Temperature levels were monitored by a thermistor and returned to a preset baseline of 32°C by active cooling at a rate of 10°C/s. The 3 × 3 cm contact probe was applied to the right forearm. The pain scale is between 0 and 10 with 1 being no pain and 10 being the worst pain imaginable|baseline, during 20 minute lidocaine infusion, and 30 minutes after completion of lidocaine infusion|||units on a scale||Standard Error|Mean
762788|NCT00657657|Secondary|Concentration of Anti-HBs Antibodies|Concentrations are given as Geometric Mean Concentrations (GMCs), calculated on subjects seropositive (subjects with anti-HBs antibody concentrations ≥ 3.3 mIU/mL) post-challenge dose.|One month after the hepatitis B vaccine challenge dose|||mIU/mL||95% Confidence Interval|Geometric Mean
762789|NCT00657657|Secondary|Number of Subjects With Anti-HBs Antibody Concentrations Above Pre-defined Cut-off Values|Anti-hepatitis B surface antigen (anti-HBs) antibody cut-off values assessed include 3.3, 10 and 100 mIU/mL.|One month after the hepatitis B vaccine challenge dose|||subjects|||Number
762774|NCT00657358|Primary|Electrical Pain|Peripheral nerve stimulation electrodes were attached to the base and the tip of the third digit and connected to a constant current stimulator (DS7A, Digitimer Ltd, Hertfordshire, England). Ascending electrical stimuli of 2000 mu duration, ranging from 0.5 to 35 mA (ampere) was administered one per second in 0.5 mA increments. Participants were instructed to indicate when they first felt the slightest sense of pain (electrical pain threshold, EPTh) and when they were unable to tolerate a further increase (electrical pain tolerance, EPTo). For each measure, the average of three trials was computed for use in subsequent analyses. Each of the three electrical pain stimuli were presented three times and balanced in order using a Graeco-Latin square design. The pain scale is between 0 and 10, with 0 being no pain and 10 being the worst pain imaginable|Baseline, during 20 minutes lidocaine infusion, and 30 minutes after completion of lidocaine infusion|||units on a scale||Standard Error|Mean
762775|NCT00657358|Primary|Ischemic Pain|The right arm was exsanguinated by elevating it above heart level for 30 seconds, after which the arm was occluded with a standard blood pressure cuff positioned proximal to the elbow inflated to twice the participant’s mean arterial pressure. Participants then performed 20 handgrip exercises of 2-second duration at 4-second intervals at 50% of their maximum grip strength. Pain was rated on a scale from 0 - 10 with 0 being no pain to 10 being the worst pain imaginable.|baseline, during 20 minute lidocaine infusion, and 30 minutes after discontinuation of lidocaine infusion|health volunteers||units on a scale||Standard Error|Mean
762776|NCT00657371|Primary|Number Polyps Detected With the Standard Colonoscope and Third Eye Retroscope (TER)|After cecal intubation, the disposable TER was inserted through the instrument channel of the colonoscope. During withdrawal, the forward and retrograde video images were observed simultaneously on a wide-screen monitor. A 2 year study period was used to collect colonoscopy exam results.|Total 30 minutes procedure time with TER use.|Those polyps reported for Third Eye Retroscope were additional, located behind folds and then found with the colonscope only because they were first detected with the Third Eye Retroscope.||polyps|Participants||Number
762777|NCT00657371|Secondary|Number Participants With Polyps Who Would Have Incorrectly Been Classified as Polyp-free Had the Third Eye Retroscope Not Been Used.|Colonoscope and TER use where during TER withdrawal forward and retrograde video images observed simultaneously on a wide-screen monitor for purpose of detecting polyps. Colonoscopy procedures completed in approximately 30 minutes total.|2 year study period to collect colonoscopy exam results||||||
762778|NCT00657371|Primary|Increase (Percent) of Polyps Detected That Would Have Been Missed Without the Third Eye Retroscope (TER)|After cecal intubation, the disposable TER was inserted through the instrument channel of the colonoscope. During withdrawal, the forward and retrograde video images were observed simultaneously on a wide-screen monitor. A 2 year study period was used to collect colonoscopy exam results.|Total 30 minutes procedure time with TER use.|||percent of polyps|Participants||Number
762779|NCT00657540|Secondary|Drug-related Serious Adverse Events|The proportion of subjects with drug-related serious adverse events.|Start of Dose 1 through 17 days post treatment|||Participants|||Count of Participants
762780|NCT00657540|Secondary|Reduction in Pain Intensity|The proportion of patients with a clinically significant decrease in pain intensity relative to baseline at any time point during the treatment phase was measured by the patient's self-assessment of pain intensity using the visual analog scale (VAS). A clinically significant reduction in pain was defined as a decrease in VAS scores of greater than or equal to 13 mm.|Start of Dose 1 to any post-infusion time point|||Participants|||Count of Participants
762781|NCT00657540|Secondary|Drug-related Adverse Events|To evaluate safety of Analatro, the proportion of subjects experiencing at least one adverse event (AE) that was determined to be related to study drug was computed for each treatment group. All AEs classified as definitely or possibly related to study drug were considered drug-related.|Start of Dose 1 through 17 days post treatment|||Participants|||Count of Participants
762782|NCT00657540|Secondary|Reduction in Pain Intensity|The proportion of patients with a clinically significant decrease in pain intensity at 30 minutes post-treatment (after Dose 1 and Dose 2, as applicable) will be measured by the patient's self-assessment of pain intensity using the visual analog scale (VAS). A clinically significant reduction in pain is defined as a decrease in VAS scores of greater than or equal to 13 mm.|30 minutes post treatment|||Participants|||Count of Participants
762783|NCT00657540|Primary|Proportion of Treatment Failures|"The primary efficacy endpoint for this study was the proportion of subjects in which pain control was not achieved 48 hours post-study drug infusion as identified by treatment failure. A treatment failure was defined as a subject who did not achieve pain control during the treatment phase, up to 48 hours after Dose 1 infusion start time. Subjects were deemed treatment failures if they met one or more of the following criteria:
Subject did not complete the treatment phase due to absence of clinically significant improvement in pain intensity relative to baseline at 60, 90, 120, or 150 minutes post start of Dose 1.
Subject required treatment with commercially available antivenin or prescription pain medication for signs and symptoms associated with latrodectism at any time during the treatment phase up to 48 hours after Dose 1 infusion start time."|From start of Dose 1 infusion to 48 hours post treatment|The analysis population consists of all subjects that were randomized and received any study drug (modified intent to treat population).||Participants|||Count of Participants
762786|NCT00657657|Secondary|Number of Subjects Reporting Serious Adverse Events|A serious adverse event is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|During the 31-day follow-up period after the challenge dose of hepatitis B vaccine|||subjects|||Number
762790|NCT00657657|Primary|Number of Subjects With an Immune Response to a Challenge Dose of Hepatitis B Vaccine|"Immune response to a challenge dose of hepatitis B vaccine is defined as
at least a 4-fold rise in post-challenge dose anti-HBs antibody concentrations in subjects seropositive (≥ 3.3 mIU/mL) at the previous available long-term time point, or
a post-challenge dose anti-HBs antibody concentrations ≥ 10 mIU/mL in subjects seronegative (<3.3 mIU/mL) at the previous available long-term time point."|One month after the hepatitis B vaccine challenge dose|||subjects|||Number
762802|NCT00658112|Primary|Adherence|Adherence to medication use as measured by MEMS cap reported as % of prescribed doses actually applied|6 weeks|||percentage of doses actually applied||Full Range|Mean
762803|NCT00658138|Primary|Percentage of Restorations Scoring Alpha|Restorations were scored Alpha, Bravo or Charlie for retention, post-operative sensitivity, anatomic form, margin integrity, color match, stain resistance, and secondary caries. Alpha score = 'excellent' Bravo = 'acceptable' Charlie = 'unsatisfactory'. Total Alpha scores were evaluated for the primary outcome.|12 months|Analysis was based on the number of study teeth available for review at 12 months||percentage of Alpha scores|Participants||Number
762804|NCT00658320|Primary|Extension Study: Renal Function Measured by Calculated Glomerular Filtration Rate (cGFR) Using the Modification of Diet in Renal Disease (MDRD) Formula|"Renal function was assessed by glomerular filtration rate (GFR) using the MDRD formula:
GFR [mL/min/1.73m2] = 186.3*(C-1.154)*(A-0.203)*G*R C is the serum concentration of creatinine [mg/dL] A is age [years] G = 0.742 when gender is female, otherwise G=1 R = 1.21 when race is black, otherwise R=1"|Month 48|Participants from the Extension Intent-to-treat population with data available for analyses.||mL/min/1.73m^2||Full Range|Median
762805|NCT00658320|Secondary|Extension Study: Cyclosporine Trough Levels|Blood was collected at all visits after Day 3 for trough (collected 5 minutes before study drug dose) cyclosporine levels and was analyzed at a central laboratory using immunoassay.|Month 24, Month 48|Participants from the Extension safety population with data available for analyses.||ng/mL||Standard Deviation|Mean
762806|NCT00658320|Secondary|Extension Study: Everolimus Trough Levels|Blood was collected at all visits after Day 3 for trough (collected 5 minutes before study drug dose) everolimus levels and was analyzed at a central laboratory using liquid chromatography mass spectrometry.|Month 24, Month 48|Participants from the Extension safety population with data available for analyses.||ng/mL||Standard Deviation|Mean
762807|NCT00658320|Secondary|Extension Study: Number of Participants With Adverse Events and Serious Adverse Events|Additional information about Adverse Events can be found in the Adverse Event Section.|24 Months|Participants from the Extension Safety Population.||Participants|||Number
762808|NCT00658320|Secondary|Extension Study: Renal Function Measured by Calculated Glomerular Filtration Rate (GFR) Using the Nankivell Formula|"The Nankivell formula was used to calculate GFR at Month 24:
GFR[mL/min]=6.7/C + W/4 - UREA/2 - 100/H^2 + 35 (25 for females) W= body weight [kg] H= height [m] C= serum creatinine [mmol/L] UREA= serum urea [mmol\L]"|Month 24, Month 48|Participants from the Extension Intent-to-treat population with data available for analyses.||mL/min||Standard Deviation|Mean
762809|NCT00658320|Secondary|Extension Study: Number of Participants With Combined Efficacy Endpoint: Graft Loss, Death, Loss to Follow-up and/or Treated Biopsy Proven Acute Rejection (BPAR)|"Graft loss was defined as the day the patient started dialysis and was not able to subsequently be removed from dialysis or re-transplant.
Loss-to-follow was a patient who did not experience a treated BPAR, graft loss or death and whose last day of contact was prior to Month 24.
A Graft Biopsy was done within 48 hours of suspect rejection. Biopsies were read by the local pathologist according to the updated Banff ’97 criteria.
Treated BPAR was based on local laboratory biopsy results and was defined as a biopsy Banff criteria graded IA to III that was treated with anti-rejection therapy."|24 Months|Extension Intent-to-treat population.||Participants|||Number
762810|NCT00658320|Primary|Extension Study: Renal Function Measured by Calculated Glomerular Filtration Rate (cGFR) Using the Modification of Diet in Renal Disease (MDRD) Formula|"Renal function was assessed by glomerular filtration rate (GFR) using the MDRD formula:
GFR [mL/min/1.73m2] = 186.3*(C-1.154)*(A-0.203)*G*R C is the serum concentration of creatinine [mg/dL] A is age [years] G = 0.742 when gender is female, otherwise G=1 R = 1.21 when race is black, otherwise R=1
Loss to follow up (in In Primary Core Outcome Measure) is composite efficacy failure and contains incidence of treated BPAR, graft loss, death or loss to follow-up"|Month 24|Participants from the Extension Intent-to-treat population with data available for analyses.||mL/min/1.73m^2||Full Range|Median
762811|NCT00658320|Secondary|Core Study: Renal Function Measured by Calculated Glomerular Filtration Rate (cGFR) Using Modification of Diet in Renal Disease (MDRD) Formula|"Modification of Diet in Renal Disease (MDRD) formula is:
Calculated GFR [mL/min/1.73m^2] = 186.3*(C^-1.154)*(A^-0.203)*G*R where
C is the serum concentration of creatinine [mg/dL],
A is patient age at sample collection date [years],
G=0.742 when gender is female, otherwise G=1,
R=1.21 when race is black, otherwise R=1"|Month 12|||mL/min/1.73m^2||Full Range|Median
762812|NCT00658320|Secondary|Core Study: Number Participants With Combined Graft Loss, Death or Loss to Follow-up|"The allograft was presumed to be lost on the day the patient starts dialysis and was not able to stop dialysis. If the patient underwent a graft nephrectomy, then the day of nephrectomy was considered as the day of graft loss.
A loss to follow-up in graft loss, death or loss to follow-up is a patient who did not experience graft loss or death and whose last day of contact was prior to Day 316, i.e. prior to the Month 12 visit window."|12 months|The Intent-To-Treat (ITT) population consisted of all patients randomized after transplantation.||Participants|||Number
762813|NCT00658320|Primary|Core Study: Number of Patients With Composite Efficacy Endpoint|"The composite efficacy endpoint consisted of treated biopsy proven acute rejection (BPAR) episodes, graft loss, death or loss to follow-up. A treated BPAR was defined as a biopsy graded IA, IB, IIA, IIB, or III and which was treated with anti-rejection therapy. The allograft was presumed to be lost on the day the patient starts dialysis and was not able to stop dialysis. If the patient underwent a graft nephrectomy, then the day of nephrectomy was considered as the day of graft loss.
For the individual components (including loss of follow-up)of the composite endpoint, patients are counted for the first event to occur."|12 months|The Intent-To-Treat (ITT) population consisted of all patients randomized after transplantation.||Participants|||Number
762814|NCT00658333|Secondary|Average Daily Doses (mg) of Enteric-coated Mycophenolate Acid (MPA) and Mycophenolate Mofetil (MMF) by Treatment Duration Intervals|The average daily doses of enteric-coated mycophenolate acid (MPA) and mycophenolate mofetil (MMF) at baseline and during the last 2 weeks of treatment. 1000 mg MMF = 720 mg enteric-coated MPA (MPA equivalent dose).|Baseline and week 4 to week 6|Safety Population||mg||Standard Deviation|Mean
762815|NCT00658333|Primary|Number of Participants With Response (Yes/no)|The primary variable was the response (yes/no) with positive response being defined as an increase of 360 mg/day enteric-coated mycophenolate acid (MPA)from the baseline daily dose, tolerated and maintained for a 4 week duration until the end of the study (Week 6). Tolerability was defined as the overall assessment of improvement or no change in the intensity of physician assessed gastrointestinal (GI) symptoms at end of study as reported on the physician administered evaluation of GI symptomatology.|6 weeks|Intent to Treat Population||Participants|||Number
762818|NCT00658411|Primary|Safety of Deferoxamine Therapy Determined by the Number of Participants With Grade 3 or Higher Toxicities.|"All patients meeting the criteria for Severe iron overload as defined by BOTH:
ferritin ≥ 1000 ng/ml and liver iron content(LIC) ≥ 5 mg/gdw were enrolled and received chelation therapy with Deferoxamine. All patients who received chelation therapy were monitored for grade 3 or above toxicity Attributable to Deferoxamine(grades defined by the CTCAE Version 3). The number of participants with grade 3 or higher toxicities were measured and used to determine the safety of chelation therapy."|Baseline , 6 month, 1 year|Patients who met criteria for iron overload pre-transplant, as defined by the protocol, were enrolled on study for chelation therapy. Those patients who received therapy were monitored for toxicities using the CTCAE version 3.0.||Participants|||Number
762819|NCT00658528|Primary|Percentage of Participants With eGERD Who Achieved Endoscopically-confirmed Healing by 4 Weeks|"Healing at week 4 or 8 were based on improvement of eGERD of the LA classification of esophagitis Grade C or D from Baseline. Classifications include:
Not Present: No breaks (erosions) in the esophageal mucosa (however, edema, erythema, or friability may be present).
Grade A: One or more mucosal breaks not more than 5 mm in maximum length. Grade B: One or more mucosal breaks more than 5 mm in maximum length, but not continuous between the tops of 2 mucosal folds.
Grade C: Mucosal breaks continuous between the tops of 2 or more mucosal folds, but involving less than 75% of the esophageal circumference.
Grade D: Mucosal breaks involving at least 75% of the esophageal circumference."|Baseline and Week 4|ITT Population||Percentage of Participants|||Number
762820|NCT00658528|Primary|Percentage of Participants With Erosive Gastroesophageal Reflux Disease (eGERD) Who Achieved Endoscopically-confirmed Healing by 8 Weeks|"Healing at week 4 or 8 were based on improvement of eGERD of the Los Angeles (LA) classification of esophagitis Grade C or D from Baseline. Classifications include:
Not Present: No breaks (erosions) in the esophageal mucosa (however, edema, erythema, or friability may be present).
Grade A: One or more mucosal breaks not more than 5 mm in maximum length. Grade B: One or more mucosal breaks more than 5 mm in maximum length, but not continuous between the tops of 2 mucosal folds.
Grade C: Mucosal breaks continuous between the tops of 2 or more mucosal folds, but involving less than 75% of the esophageal circumference.
Gread D: Mucosal breaks involving at least 75% of the esophageal circumference."|Baseline and Week 8|Intent-to-Treat (ITT) Population - all randomized participants who received at least 1 dose of study drug.||Percentage of Participants|||Number
762821|NCT00658528|Secondary|Percentage of Participants Who Achieved Diary-recorded Sustained Resolution of Heartburn by Week 4|During the first 4 weeks of the Double-blind Phase, participants were to record heartburn in a daily diary. Participant daily symptoms for the assessment of hearburn was based on a commonly used 4-point Likert scale of none, mild, moderate and severe. A participant was considered achieving sustained resolution of heartburn if the participant had maintained at least 7 consecutive heartburn-free days.|Week 4|ITT Population||Percentage of Participants|||Number
762822|NCT00658541|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]for Zolpidem Tartrate|The area under the zolpidem tartrate plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant|serial pharmacokinetic blood samples drawn prior to dosing (hour 0), then 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 4, 5, 6, 8, 10, and 12 hours after dose administration|Plasma concentration data for 35 of 38 participants were used in the statistical analysis. One subject dropped from the study during Period I and two subjects dropped from the study after Period I.||ng-hr/mL||Standard Deviation|Mean
762823|NCT00658541|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] for Zolpidem Tartrate|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable zolpidem tartrate concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic blood samples drawn prior to dosing (hour 0), and then at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 4, 5, 6, 8, 10, and 12 hours after dose administration|Plasma concentration data for 35 of 38 participants were used in the statistical analysis. One subject dropped from the study during Period I and two subjects dropped from the study after Period I.||ng-hr/mL||Standard Deviation|Mean
762824|NCT00658541|Primary|Maximum Plasma Concentration (Cmax) for Zolpidem Tartrate|The maximum or peak concentration that zolpidem tartrate reaches in the plasma.|serial pharmacokinetic blood samples drawn prior to dosing (hour 0), and then at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 4, 5, 6, 8, 10, and 12 hours after dose administration|Plasma concentration data for 35 of 38 participants were used in the statistical analysis. One subject dropped from the study during Period I and two subjects dropped from the study after Period I.||ng/mL||Standard Deviation|Mean
762825|NCT00658567|Secondary|Motor Symptoms Change From Baseline (Negative = Improvement)|"Motor symptoms were measured using the change from baseline (Day 1) to Day 42 in the combined score of the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) and Part III (Motor Examination). The total possible score is 0 to 160 and a negative change in score indicates improvement.
Analysis Method: ANCOVA, and missing data was imputed using LOCF method. The UPDRS Parts II+III score was analyzed by constructing 2-sided 95% confidence intervals (CIs) on the difference between each pimavanserin dose group and placebo mean change from baseline. Non-inferiority was concluded if the upper limit of the CI was less than or equal to 5."|Each study visit (i.e. Days 1, 8, 15, 29 and 42)|This is the “Intent to Treat” population, defined as patients who received at least one dose of study drug and had both the baseline SAPS assessment and at least one post-baseline SAPS assessment.||Score on UPDRS-II+III scale.||95% Confidence Interval|Least Squares Mean
762826|NCT00658567|Primary|Antipsychotic Efficacy|"Antipsychotic efficacy was defined as a decrease in the severity and/or frequency of hallucinations and/or delusions. This is measured as the change from baseline (Day 1) to Day 42 in the Scale for the Assessment of Positive Symptoms - Hallucinations and Delusions scales (SAPS-H+D) score for the ITT Analysis Set. The possible total score is 1 to 100 and a negative change in score indicates improvement.
Analysis Method: Analysis of Covariance (ANCOVA) and missing data was imputed using Last Observation Carried Forward (LOCF) method."|Each study visit (i.e. Days 1, 8, 15, 29 and 42)|This is the “Intent to Treat” population, defined as patients who received at least one dose of study drug and had both the baseline SAPS assessment and at least one post-baseline SAPS assessment.||Scores on the SAPS H+D scale||95% Confidence Interval|Least Squares Mean
762827|NCT00658606|Secondary|Change in Dermatology Life Quality Index (DLQI)|"The DLQI questionnaire is intended to measure how much a subject’s skin problem affects the subject’s life. Subjects provide answers considering the past week. The scale of the DQLI ranges from 0 (best) to 30 (worst).
A negative change from Baseline represents improvement.
Change is calculated as Week 36- Baseline.
The Last Observation Carry Forward (LOCF) method was used to impute missing data."|Baseline and Week 36|"The number of participants analyzed per arm represents the ITT-Efficacy Population, which consisted of all subjects randomized into the study who received at least one dose of study drug (alefacept).
The number of participants per arm is consistent for all categories / rows of the data table."||DLQI Score||Standard Deviation|Mean
762828|NCT00658606|Secondary|Time for a 75% Decrease in PASI|"The PASI score is a tool that allows investigators to assign an objective number to the degree of severity of a person’s psoriasis, and considers: redness, scaling and thickness. Values for PASI score range from 0 (least) to 72 (worst).
Only subjects who experienced 75% decrease in PASI were included in the analysis."|Week 36|"The number of participants analyzed per arm represents the ITT-Efficacy Population, which consisted of all subjects randomized into the study who received at least one dose of study drug (alefacept).
Only subjects who experienced a 75% decrease in PASI were included in the analysis."||Days||Inter-Quartile Range|Mean
762829|NCT00658606|Secondary|Time for 50% Decrease in PASI|"The PASI score is a tool that allows investigators to assign an objective number to the degree of severity of a person's psoriasis, and considers: redness, scaling and thickness. Values for PASI score range from 0 (least) to 72 (worst).
Only subjects who experienced 50% decrease in PASI were included in the analysis."|Week 36|"The number of participants analyzed per arm represents the ITT-Efficacy Population, which consisted of all subjects randomized into the study who received at least one dose of study drug (alefacept).
Only subjects who experienced a 50% decrease in PASI were included in the analysis."||Days||Inter-Quartile Range|Median
762830|NCT00658606|Secondary|Time to Relapse|"The analysis only included subjects who achieved a 75% improvement in PASI and then relapsed.
Relapse is defined by a loss of 50% of improvement in PASI."|Week 36|"The number of participants analyzed per arm represents the ITT-Efficacy Population, which consisted of all subjects randomized into the study who received at least one dose of study drug (alefacept).
Only subjects who achieved a 75% improvement in PASI and then relapsed were included in the analysis."||Days||Standard Deviation|Mean
762831|NCT00658606|Secondary|Percentage of Subjects Who Achieve PASI 90 at Week 16|"The PASI score is a tool that allows investigators to assign an objective number to the degree of severity of a person’s psoriasis, and considers: redness, scaling and thickness. Values for PASI score range from 0 (least) to 72 (worst).
PASI 90 was defined as an improvement of at least 90% in PASI as compared to Baseline.
The Last Observation Carry Forward (LOCF) method was used to impute missing data."|Week 16|The number of participants analyzed per arm represents the ITT-Efficacy Population, which consisted of all subjects randomized into the study who received at least one dose of study drug (alefacept).||Percentage of Subjects|||Number
762832|NCT00658606|Secondary|Percentage of Subjects Who Achieved Physical Global Assessment (PGA) of Clear or Almost Clear Over the Entire Course of the Study|"The PGA scale is a tool used to evaluate the degree of overall lesion severity. The scale ranges from 0 (clear) to 5 (very severe). Clear is defined as a score of 0; Almost Clear is defined as a score of 1.
Subjects who achieved PGA of clear or almost clear at any visit during the study were assigned to the YES category for their respective groups.
The Last Observation Carry Forward (LOCF) method was used to impute missing data."|Week 36|The number of participants analyzed per arm represents the ITT-Efficacy Population, which consisted of all subjects randomized into the study who received at least one dose of study drug (alefacept).||Percentage of Subjects|||Number
762833|NCT00658606|Secondary|Percentage of Subjects Who Achieved Physical Global Assessment (PGA) of Clear or Almost Clear at Week 16|"The PGA scale is a tool used to evaluate the degree of overall lesion severity. The scale ranges from 0 (clear) to 5 (very severe). Clear is defined as a score of 0; Almost Clear is defined as a score of 1.
Subjects who achieved PGA of clear or almost clear at any visit during the study were assigned to the YES category for their respective groups.
The Last Observation Carry Forward (LOCF) method was used to impute missing data."|Week 16|The number of participants analyzed per arm represents the ITT-Efficacy Population, which consisted of all subjects randomized into the study who received at least one dose of study drug (alefacept).||Percentage of Subjects|||Number
762834|NCT00658606|Secondary|Change in Body Surface Area (BSA) Covered With Psoriasis Over the Entire Course of the Study|"A negative change from Baseline represents improvement.
Change is calculated as Week 36- Baseline.
The Last Observation Carry Forward (LOCF) method was used to impute missing data."|Baseline and Week 36|"The number of participants analyzed per arm represents the ITT-Efficacy Population, which consisted of all subjects randomized into the study who received at least one dose of study drug (alefacept).
The number of participants per arm is consistent for all categories / rows of the data table."||Percentage of BSA||Standard Deviation|Mean
762835|NCT00658606|Secondary|Change in Body Surface Area (BSA) Covered With Psoriasis at Week 16|"A negative change from Baseline represents improvement.
Change is calculated as Week 16- Baseline.
The Last Observation Carry Forward (LOCF) method was used to impute missing data."|Baseline and Week 16|"The number of participants analyzed per arm represents the ITT-Efficacy Population, which consisted of all subjects randomized into the study who received at least one dose of study drug (alefacept).
The number of participants per arm is consistent for all categories / rows of the data table."||Percentage of BSA||Standard Deviation|Mean
762836|NCT00658606|Secondary|Percentage of Subjects Reaching PASI 75 Over the Entire Course of the Study|"The PASI score is a tool that allows investigators to assign an objective number to the degree of severity of a person’s psoriasis, and considers: redness, scaling and thickness. Values for PASI score range from 0 (least) to 72 (worst).
PASI 75 was defined as an improvement of at least 75% in PASI as compared to Baseline.
The Last Observation Carry Forward (LOCF) method was used to impute missing data."|Week 36|"The number of participants analyzed per arm represents the ITT-Efficacy Population, which consisted of all subjects randomized into the study who received at least one dose of study drug (alefacept).
Only subjects who completed follow-up were included in this analysis."||Percentage of Subjects|||Number
762876|NCT00658723|Secondary|Incidence of Adverse Events That Are Potentially Related to Bleeding|The types of events that were potentially related to bleeding included operative hemorrhage and re-bleeding of the target bleeding site (TBS).|Intra-operative up to 1 month (+14 days)|||percentage of particpants|||Number
762837|NCT00658606|Primary|Percentage of Subjects Who Achieve Psoriasis Area and Severity Index (PASI) 75 at Week 16|"The PASI score is a tool that allows investigators to assign an objective number to the degree of severity of a person’s psoriasis, and considers: redness, scaling and thickness. Values for PASI score range from 0 (least) to 72 (worst).
PASI 75 was defined as an improvement of at least 75% in PASI as compared to Baseline.
The Last Observation Carry Forward (LOCF) method was used to impute missing data."|Week 16|The number of participants analyzed per arm represents the ITT-Efficacy Population, which consisted of all subjects randomized into the study who received at least one dose of study drug (alefacept).||Percentage of Subjects|||Number
762838|NCT00658619|Secondary|Change From Baseline in Reading Speed in the Study Eye|Change from baseline in reading speed in the study eye is assessed using modified Bailey-Lovie word charts. Patients read the chart for 2 minutes and the numbers of words read correctly per minute are totaled. An increase in the number of words read correctly indicates an improvement and a decrease in the number of words read correctly indicates a worsening.|Baseline, 24 Months|Intent-to-Treat: All randomized patients who participated in Stage 2||Words per Minute (wpm)||Standard Deviation|Mean
762839|NCT00658619|Secondary|Change From Baseline in Contrast Sensitivity in the Study Eye|Change from baseline in contrast sensitivity in the study eye is measured using a Pelli-Robson contrast sensitivity chart at 1 meter. The contrast sensitivity chart contains letters that are darkest at the top and then get progressively lighter. Scores range from 0 to 48 and are based on the number of letters read correctly. A negative change from baseline indicates a worsening in contrast sensitivity and a positive change from baseline indicates an improvement.|Baseline, 24 Months|Intent-to-Treat: All randomized patients who participated in Stage 2||Number of Letters Read Correctly||Standard Deviation|Mean
762840|NCT00658619|Secondary|Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening.|Baseline, 24 Months|Intent-to-Treat: All randomized patients who participated in Stage 2||Number of Letters Read Correctly||Standard Deviation|Mean
762841|NCT00658619|Secondary|Change From Baseline in Size of Geographic Atrophy Lesion Area in the Study Eye|Change from baseline in size of geographic atrophy lesion area in the study eye is based on fundus photography as read by an independent Reading Center. Photographs are taken with a specialized microscope with an attached camera to photograph the interior of the eye, including the retina and optic disc. A positive change from baseline indicates an increase in size of geographic atrophy lesion area (worsening; disease progression). Data are reported in disc area where 1 disc area = 2.54 millimeters squared (mm^2).|Baseline, Month 3, Month 6, Month 9, Month 18, Month 24|Intent-to-Treat: All randomized patients who participated in Stage 2||Disc Area||Standard Deviation|Mean
762842|NCT00658619|Primary|Change From Baseline in Size of Geographic Atrophy Lesion Area in the Study Eye|Change from baseline in size of geographic atrophy lesion area in the study eye is based on fundus photography as read by an independent Reading Center. Photographs are taken with a specialized microscope with an attached camera to photograph the interior of the eye, including the retina and optic disc. A positive change from baseline indicates an increase in size of geographic atrophy lesion area (worsening; disease progression). Data are reported in disc area where 1 disc area = 2.54 millimeters squared (mm^2).|Baseline, Month 12|Intent-to-Treat: All randomized patients who participated in Stage 2||Disc Area||Standard Deviation|Mean
762843|NCT00658632|Primary|Percentage of Participants With eGERD Who Achieved Endoscopically-confirmed Healing by 4 Weeks|"Healing at Week 4 or 8 were based on improvement of eGERD of the LA classification of esophagitis Grade A or B from Baseline. Classifications include:
Not Present: No breaks (erosions) in the esophageal mucosa (however, edema, erythema, or friability may be present).
Grade A: One or more mucosal breaks not more than 5mm in maximum length. Grade B: One or more mucosal breaks more than 5mm in maximum length, but not continuous between the tops of 2 mucosal folds.
Grade C: Mucosal breaks continuous between the tops of 2 or more mucosal folds, but involving less than 75% of the esophageal circumference.
Gread D: Mucosal breaks involving at least 75% of the esophageal circumference."|Baseline and Week 4|The analysis was performed using the ITT population, defined as all randomized subjects who received at least 1 dose of study drug, minus two participants from one site who were excluded from the ITT Population per an agreement with the FDA due to concerns of possible misconduct.||Percentage of Participants|||Number
762844|NCT00658632|Primary|Percentage of Participants With Erosive Gastroesophageal Reflux Disease (eGERD) Who Achieved Endoscopically-confirmed Healing by 8 Weeks|"Healing at Week 4 or 8 were based on improvement of eGERD of the Los Angeles (LA) classification of esophagitis Grade A or B from Baseline. Classifications include:
Not Present: No breaks (erosions) in the esophageal mucosa (however, edema, erythema, or friability may be present).
Grade A: One or more mucosal breaks not more than 5mm in maximum length. Grade B: One or more mucosal breaks more than 5mm in maximum length, but not continuous between the tops of 2 mucosal folds.
Grade C: Mucosal breaks continuous between the tops of 2 or more mucosal folds, but involving less than 75% of the esophageal circumference.
Gread D: Mucosal breaks involving at least 75% of the esophageal circumference."|Baseline and Week 8|The analysis was performed using the Intent-to-Treat (ITT) population, defined as all randomized subjects who received at least 1 dose of study drug, minus two participants from one site who were excluded from the ITT Population per an agreement with the FDA due to concerns of possible misconduct.||Percentage of Participants|||Number
762845|NCT00658632|Secondary|Percentage of Participants Who Achieved Diary-recorded Sustained Resolution of Heartburn by Week 4|During the first 4 weeks of the Double-blind Phase, participants were to record heartburn in a daily diary. Participant daily symptoms for the assessment of heartburn was based on a commonly used 4-point Likert scale of none, mild, moderate and severe. A participant was considered achieving sustained resolution of heartburn if the participant had maintained at least 7 consecutive heartburn-free days.|Week 4|The analysis was performed using the ITT population, defined as all randomized subjects who received at least 1 dose of study drug, minus two participants from one site who were excluded from the ITT Population per an agreement with the FDA due to concerns of possible misconduct.||Percentage of Participants|||Number
762877|NCT00658723|Secondary|Incidence of Treatment Failures|If hemostasis was not achieved within 4 minutes or if bleeding required additional intervention during the 6 minute observation period, the treatment was considered to be a failure.|Intra-operative|||percentage of treatment failure|||Number
762846|NCT00658658|Secondary|Percentage of Participants With Disease Control|"Disease assessments were based on investigator review of scans using modified RECIST version 1.0 criteria. A participant was considered to have disease control if their best response is either a complete or partial response, or stable disease. Participants without a post-baseline assessment were considered to not have disease control. A complete or partial response was confirmed no less than 4-weeks after the criteria for response were first met. A best overall response of SD requires a visit response of SD or better, no earlier than 49 days after the date of enrollment.
Stable disease (SD): Neither sufficient shrinkage of target lesions to qualify for a PR nor sufficient increase to qualify for PD and no progression of existing non-target lesions and no new lesions."|Tumor response was assessed every 8 weeks through week 48 and every 3 months thereafter until disease progression or end of study. The data cut-off for the analysis was 17 June 2015; median duration of study was 47 days.|Safety Analysis Set participants with presence of baseline measurable disease||percentage of participants||95% Confidence Interval|Number
762847|NCT00658658|Secondary|Percentage of Participants With an Objective Response|Disease assessments were based on investigator review of scans using modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 criteria. A participant was considered a responder if their best response was either a complete or partial response. Participants without a post-baseline assessment were considered non-responders. A complete or partial response was confirmed no less than 4-weeks after the criteria for response were first met. Complete Response (CR): Disappearance of all target and non-target lesions, normalization of tumor markers and no new lesions. Partial Response (PR): At least a 30% decrease in the size of target lesions, no progression of non-target lesions and no new lesions, or, the disappearance of all target lesions, persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease (PD) or/and maintenance of tumor marker level above normal limits, and no new lesions.|Tumor response was assessed every 8 weeks through week 48 and every 3 months thereafter until disease progression or end of study. The data cut-off for the analysis was 17 June 2015; median duration of study was 47 days.|Safety Analysis Set participants with presence of baseline measurable disease||percentage of participants||95% Confidence Interval|Number
762848|NCT00658658|Primary|Serum Clearance (CL) of Panitumumab||First dose (Day 1) and third dose (Day 15/29/43 for the QW, Q2W and Q3W cohorts respectively). Samples were collected over the dosing interval for each treatment cohort (7, 14 or 21 days for QW, Q2W and Q3W cohorts respectively).|"PK analysis set; n indicates the number of participants with available data for each time point."||mL/day/kg||Standard Deviation|Mean
762849|NCT00658658|Primary|Half-life (t1/2) for the Terminal Phase (First Dose) or Dosing Interval (Third Dose) of Panitumumab||First dose (Day 1) and third dose (Day 15/29/43 for the QW, Q2W and Q3W cohorts respectively). Samples were collected over the dosing interval for each treatment cohort (7, 14 or 21 days for QW, Q2W and Q3W cohorts respectively).|"PK analysis set; n indicates the number of participants with available data for each time point."||days||Standard Deviation|Mean
762850|NCT00658658|Primary|Area Under the Concentration-time Curve During the Dosing Interval (AUC0-tau) for Panitumumab|The area under the serum concentration-time curve from time zero to the end of the dosing interval (AUCtau), estimated using the linear trapezoidal method.|First dose (Day 1) and third dose (Day 15/29/43 for the QW, Q2W and Q3W cohorts respectively). Samples were collected over the dosing interval for each treatment cohort (7, 14 or 21 days for QW, Q2W and Q3W cohorts respectively).|"PK analysis set; n indicates the number of participants with available data for each time point."||day*μg/mL||Standard Deviation|Mean
762851|NCT00658658|Primary|Minimum Observed Concentration (Cmin) of Panitumumab||First dose (Day 1) and third dose (Day 15/29/43 for the QW, Q2W and Q3W cohorts respectively). Samples were collected over the dosing interval for each treatment cohort (7, 14 or 21 days for QW, Q2W and Q3W cohorts respectively).|"PK analysis set; n indicates the number of participants with available data for each time point."||μg/mL||Standard Deviation|Mean
762852|NCT00658658|Primary|Maximum Observed Concentration (Cmax) of Panitumumab|Panitumumab serum concentration was measured using an enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) of the assay was 400 pg/mL. Concentrations below the LLOQ were set to zero.|First dose (Day 1) and third dose (Day 15/29/43 for the QW, Q2W and Q3W cohorts respectively). Samples were collected over the dosing interval for each treatment cohort (7, 14 or 21 days for QW, Q2W and Q3W cohorts respectively).|"Pharmacokinetic (PK) Analysis Set (all participants who received the correct dose of panitumumab and from whom the PK parameters could be assessed); n indicates the number of participants with available data for each time point."||μg/mL||Standard Deviation|Mean
762853|NCT00658658|Primary|Number of Participants With Adverse Events (AEs)|A serious adverse event is defined as an AE that: • is fatal; • is life threatening; • requires in-patient hospitalization or prolongation of existing hospitalization; • results in persistent or significant disability/incapacity; • is a congenital anomaly/birth defect; • other significant medical hazard. The investigator assessed whether adverse events were related to panitumumab. The severity of adverse events was based on CTCAE version 3 (with the exception of skin- or nail-related toxicities which were graded using the CTCAE version 3.0 with modifications), according to the following: Grade 1 = Mild (aware of sign or symptom, but easily tolerated); Grade 2 = Moderate (discomfort enough to cause interference with usual activity); Grade 3 = Severe (incapacitating with inability to work or do usual activity); Grade 4 = Life-threatening or disabling; Grade 5 = Fatal.|From first dose date to end of study date. The median duration of study was 47 days.|Safety Analysis Set (all participants who received at least 1 dose of panitumumab)||participants|||Number
762854|NCT00658658|Secondary|Number of Participants Who Developed Antibodies to Panitumumab|Three validated assays were used to detect the presence of anti-panitumumab antibodies. Two screening immunoassays, an acid-dissociation enzyme-linked immunosorbent assay (ELISA) and a Biacore-based biosensor assay, were used to detect antibodies capable of binding to panitumumab. All samples confirmed to be positive by drug specificity in either screening immunoassay were further tested for neutralizing antibodies in a cell-based epidermal growth factor receptor (EGFR) phosphorylation bioassay. The number of participants who developed antibodies to panitumumab is the number of participants with a non-positive (including missing) antibody result at baseline and a positive antibody result at any post-baseline time point.|Before panitumumab administration on Day 1, Day 43, Day 169 and 30 days after last dose for all cohorts.|Safety Analysis Set participants with at least one post-baseline immunoassay result||participants|||Number
762855|NCT00658658|Primary|Number of Participants With Dose-limiting Toxicities (DLTs)|Any panitumumab related grade 3 or 4 hematologic or non-hematologic toxicity (graded according to the modified Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 criteria) was considered a DLT with the exception of alopecia and fatigue. Hypomagnesemia, nausea, diarrhea, vomiting, and skin or nail toxicities constituted a DLT only of the following occured: • Grade 3 or 4 hypomagnesemia that persisted for at least 5 days despite maximal magnesium replacement; • Grade 3 or 4 diarrhea, nausea, or vomiting that persisted for at least 5 days despite maximum supportive therapy; • Grade 4 skin or nail toxicity.|28 days from initial administration of panitumumab for the 2.5 and 6 mg/kg cohorts and 21 days from first administration for the 9 mg/kg cohort.|DLT Analysis Set (all participants who received at least 1 dose of panitumumab and were evaluated for DLTs and completed at least 28 days (for the 2.5 and 6 mg/kg cohorts) or 21 days (for 9 mg/kg cohort) of therapy unless due to a DLT)||participants|||Number
762856|NCT00658684|Primary|Safety Measurement Based on Adverse Events (AEs), Vital Signs, Clinical Laboratory Test, 12-lead ECG and Residual Urine Volume|The number of subjects who experienced AEs (all causality and treatment-related ) based on safety assessment during the study were summarized. The severity and seriousness of treatment-emergent AEs as well as discontinuations, dose reductions and temporary discontinuations (DR/TD) due to treatment-emergent AEs were also summarized.|52 Weeks|The safety analysis set (all subjects who took at least one dose of study drug) was analyzed.||Number of subjects|||Number
762857|NCT00658684|Secondary|Change From Baseline in Grade of PPBC at Week 28 and 52|"The PPBC assessment was rated on a 6-point scale as follows:
no problems at all
some very minor problems
some minor problems
some moderate problems
severe problems
many severe problems
Change: mean at Week 28 and 52 minus mean at baseline A negative change indicates improvement."|Week 28 and 52|The efficacy analysis set (those who took at least one dose of study drug and contributed data to baseline and at least one valid post-baseline efficacy assessment) was analyzed. Observed values were used for the analyses. (n=analyzable subjects)||Scores on a scale||Standard Deviation|Mean
762858|NCT00658684|Secondary|The Number of Subjects Shifted in Patient Perception of Bladder Condition (PPBC) Responses From Baseilne to Week 28 and 52 Assessment and Its Percentage|"The number of subjects whose perception of bladder condition improved at least by one grade on PPBC from baseline at Week 28 and 52. The PPBC was rated on a 6-point scale as follows:
no problems at all
some very minor problems
some minor problems
some moderate problems
severe problems
many severe problems"|Week 28 and 52|The efficacy analysis set (those who took at least one dose of study drug and contributed data to baseline and at least one valid post-baseline efficacy assessment) was analyzed. Observed values were used for the analyses. (n=number of analyzable subjects)||Number of subjects|||Number
762859|NCT00658684|Secondary|Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52|"OAB-q was used to assess the extent of subjects who had been botehred by selected bladder symptoms and to assess the effect on their health-related quality of life (HRQL). OAB-q consists of the symptom bother score(SBS), the HRQL total score and subscale scores (Coping, Concern, Sleep and Social). The SBS ranges from 0 to 100, where 0=minimal severity and 100=greatest severity (negative change indicates improvement). The HRQL scores range from 0 to 100, where 0=worst outcome and 100=best outcome (positive change indicates improvement).
Change: mean at Week 28 and 52 minus mean at baseline"|Week 28 and 52|The efficacy analysis set (those who took at least one dose of study drug and contributed data to baseline and at least one valid post-baseline efficacy assessment) was analyzed. Observed values were used for the analyses. (n=analyzable subjects)||Scores on a scale||Standard Deviation|Mean
762860|NCT00658684|Secondary|Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52|"KHQ was used to assess the impact of bladder problems on quality of life. The scores ranged from 0 to 100, where 0=best outcome/response and 100=worst outcome/response. A negative change indicates improvement.
KHQ consists of the following domains:
General health perceptions (GHP)
Impact on life
Role limitations
Physical limitations
Social limitations
Personal relationships (PR)
Emotions
Sleep/energy
Incontinence severity measures (ISM)
Change: mean at Week 28 and 52 minus mean at Baseline"|Week 28 and 52|The efficacy analysis set (those who took at least one dose of study drug and contributed data to baseline and at least one valid post-baseline efficacy assessment) was analyzed. Observed values were used for the analyses. (n=number of analyzable subjects)||Scores on a ascle||Standard Deviation|Mean
762861|NCT00658684|Secondary|Change From Baseline in Mean Voided Volume Per Micturition at Week 4, 8, 28 and 52|"Voided volume per micturition was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.
The mean voided volume per micturitions was calculated as the total voided volume for valid diary days divided by the total number of valid diary days collected at that visit.
Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline"|Week 4, 8, 28 and 52|The efficacy analysis set (those who took at least one dose of study drug and contributed data to baseline and at least one valid post-baseline efficacy assessment) was analyzed. Observed values were used for the analyses. Only at Week 52, the imputed data for missing values by using LOCF were analyzed. (n=number of analyzable subjects)||mL||Standard Deviation|Mean
762862|NCT00658684|Secondary|Change From Baseline in Number of Nighttime Micturitions Per 24 Hours at Week 4, 8, 28 and 52|"The number of nighttime micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.
The mean number of nighttime micturitions per 24 hours was calculated as the total number of nighttime micturitions for valid diary days divided by the total number of valid diary days collected at that visit.
Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline"|Week 4, 8, 28 and 52|Of the efficacy analysis set, the subjects whose mean number of nighttime micturitions per 24 hours at baseline was greater than 0 were analyzed. Observed values were used for the analyses. Only at Week 52, the imputed data for missing values by using LOCF were also analyzed. (n=number of analyzable subjects)||Number of micturitions||Standard Deviation|Mean
762878|NCT00658723|Secondary|Proportion of Subjects Achieving Hemostatic Success|The proportion of subjects achieving hemostatic success at 10 minutes following randomization|10 minutes|||percentage of success|||Number
762879|NCT00658723|Primary|Proportion of Subjects Achieving Hemostatic Success|Proportion of success in achieving hemostasis at 4 minutes after randomization with no re-bleeding requiring treatment during a subsequent 6-minute observation period.|Intra-operative|||percentage of success|||Number
764991|NCT00673231|Other Pre-specified|Proportion of Participants With Lack of Glycemic Control|Participants with lack of glycemic control or insulin up-titration for failing to achieve pre-specified glycemic targets|Baseline to Week 24|Full Analysis Set||Participants|||Number
762863|NCT00658684|Secondary|Change From Baseline in Mean Incontinence Episodes Per 24 Hours at Week 4, 8, 28 and 52|"The number of incontinence episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.
The mean number of incontinence episodes per 24 hours was calculated as the total number of incontinence episodes for valid diary days divided by the total number of valid diary days collected at that visit.
Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline"|Week 4, 8, 28 and 52|Of the efficacy analysis set, the subjects whose mean number of incontinence episodes per 24 hours at baseline was greater than 0 were analyzed. Observed values were used for the analyses. Only at Week 52, the imputed data for missing values by using LOCF were also analyzed. (n= number of analyzable subjects)||Number of episodes||Standard Deviation|Mean
762864|NCT00658684|Secondary|Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 4, 8, 28 and 52|"The number of urgency episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.
The mean number of urgency episodes per 24 hours was calculated as the total number of urgency episodes for valid diary days divided by the total number of valid diary days collected at that visit.
Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline"|Week 4, 8, 28 and 52|The efficacy analysis set (those who took at least one dose of study drug and contributed data to baseline and at least one valid post-baseline efficacy assessment) was analyzed. Observed values were used for the analyses. Only at Week 52, the imputed data for missing values by using LOCF were also analyzed. (n=number of analyzable subjects)||Number of episodes||Standard Deviation|Mean
762865|NCT00658684|Secondary|Change From Baseline in Mean Number of Micturitions at Week 4, 8, 28 and 52|"The number of micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.
The mean number of micturitions per 24 hours was calculated as the total number of micturitions for valid diary days divided by the total number of valid diary days collected at that visit.
Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline"|Week 4, 8, 28 and 52|The efficacy analysis set (those who took at least one dose of study drug and contributed data to baseline and at least one valid post-baseline efficacy assessment) was analyzed. Observed values were used for the analyses. Only at Week 52, the imputed data for missing values by using LOCF were also analyzed. (n=number of anlyzable subjects)||Number of micturitions||Standard Deviation|Mean
762866|NCT00658684|Secondary|Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4, 8, 28 and 52|"The number of UUI episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.
The mean number of UUI episodes per 24 hours was calculated as the total number of UUI episodes for valid diary days divided by the total number of valid diary days collected at that visit.
Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline"|Week 4, 8, 28 and 52|Of the efficacy analysis set, the subjects whose mean number of UUI episodes per 24 hours at baseline was greater than 0 were analyzed. Observed values were used for the analyses. Only at Week 52, the imputed data for missing values by using last observation carried forward (LOCF) were analyzed. (n=number of analyzable subjects)||Number of episodes||Standard Deviation|Mean
762867|NCT00658697|Secondary|Toxicity|Treatment related adverse events were graded based on CTCAE v. 3.0.|Assessed each cycle throughout treatment form time of first dose to 30 days post-treatment, up to 2 years|All patients received at least one study therapies||participants|||Number
762868|NCT00658697|Primary|Prostate-Specific Antigen (PSA) Progression at 1 Year After Completing Androgen Deprivation Therapy (ADT)|"For prostatectomy patients: at least two serial rising PSA from treatment nadir and PSA > 0.2 ng/mL.
For patient receiving radiation therapy alone as primary local therapy, at least two serial rising PSA from treatment nadir and PSA >2.0 ng/mL.
Any new site of metastatic disease on imagining would be considered progression regardless of PSA value Clinical assessments (Vitals, Physical Exam, Performance Status, PSA and testosterone) were performed every 3 months starting at completion of hormone therapy until PSA progression."|participants were followed for the duration of the study, an average of 2 years|||percentage of participants with data||95% Confidence Interval|Number
762869|NCT00658697|Secondary|Testosterone Recovery|Testosterone recovery was defined as >100 or within DFCI institute normal range (240-950) at one year after the completion of ADT|2 years|All treated patients with assessable testosterone level data||percentage of participants with data||95% Confidence Interval|Number
762870|NCT00658697|Secondary|Time to PSA Progression (TTP)|For prostatectomy patients: at least two serial rising PSA from treatment nadir and PSA > 0.2 ng/mL. For patient receiving radiation therapy alone as primary local therapy, at least two serial rising PSA from treatment nadir and PSA > 2.0 ng/mL. Any new site of metastatic disease on imagining would be considered progression regardless of PSA value|participants were followed for the duration of the study, an average of 2 years|the analysis dataset is comprised of all treated patients||months||95% Confidence Interval|Median
762871|NCT00658697|Secondary|Proportion of Patients With PSA Responses at One Year After the Completion of ADT|The PSA response was defined using two cut-offs: PSA <0.2 ng/mL or PSA <0.01 ng/mL at the one year after completion of ADT.|1 year + 3 month off last ADT injection|"The analysis comprised of all patients received at least one treatment and had PSA data available* for the assessment of PSA responses at one year after completing ADT
*Note excluded 5 patients started treatments but had no PSA information at one year."||percentage of participants with data||95% Confidence Interval|Number
762872|NCT00658723|Secondary|Incidence of Adverse Events||30 days (+14 days)|||% if participants with atleast one AE|||Number
762873|NCT00658723|Secondary|Incidence of Re-treatment|"The outcome measure assess if re-treatment was done after release of manual compression at 4-minutes for subjects not achieving hemostatic success or if re-treatment was done during the 6-minute observation period.
In the SURGICEL group, 18 subjects had initial hemostatic success at 4 minutes, but 2 of the 18 subjects were re-treated for re-bleeding. In the SURGICEL group, 12 subjects were not hemostatic at 4-minutes and had a re-treatment."|Intra-operative|||participants|||Number
762874|NCT00658723|Secondary|Incidence of Adverse Events Potentially Related to Transfusion Exposure|The types of events that were potentially related to transfusion exposure could have include hypocalcemia.|Intra-operative up to 1 month (+14 days)|||percentage of particpants|||Number
762875|NCT00658723|Secondary|Incidence of Adverse Events That Are Potentially Related to Thrombotic Events|The types of events that were potentially related to thrombotic events included deep vein thrombosis and pulmonary embolism|Intra-operative up to 1 month (+14 days)|||percentage of participants|||Number
765032|NCT00674154|Secondary|Increase in Trabecular and Cortical vBMD Measured by QCT and pQCT of Hip, Spine and Forearm||one year||||||
762880|NCT00658736|Secondary|Change From Baseline in Quality of Life Score at 1 Month - SF12 Physical Component|The SF12 survey measures patients' impressions of their level of health and well-being. The results are reported as two scores: A physical component and a mental component, each of which is reported on a scale of 0 (lowest level of health) to 100 (excellent health). Scores that increase from baseline indicate an improvement in patients' feelings of well-being.|1 month|||units on a scale||Standard Deviation|Mean
762881|NCT00658736|Primary|Change in Pain Disability Index|The Pain Disability Index (PDI) measures patients' responses of the extent to which pain limits their abilities to carry out everyday tasks. The index is scored from 0 (no limitation) to 70 (severe limitation). A decrease in score of 10 points or more is regarded as indicating significant improvement in the ability to carry out daily activities.|1 month after block|||Participants|||Count of Participants
762882|NCT00658775|Primary|Percentage of Participants With eGERD Who Achieved Endoscopically-confirmed Healing by 4 Weeks|"Healing at week 4 or 8 were based on improvement of eGERD of the LA classification of esophagitis Grade C or D from Baseline. Classifications include:
Not Present: No breaks (erosions) in the esophageal mucosa (however, edema, erythema, or friability may be present) Grade A: One or more mucosal breaks not more than 5mm in maximum length. Grade B: One or more mucosal breaks more than 5mm in maximum length, but not continuous between the tops of 2 mucosal folds.
Grade C: Mucosal breaks continuous between the tops of 2 or more mucosal folds, but involving less than 75% of the esophageal circumference.
Grade D: Mucosal breaks involving at least 75% of the esophageal circumference."|Baseline and Week 4|ITT Population||Percentage of Participants|||Number
762883|NCT00658775|Primary|Percentage of Participants With Erosive Gastroesophageal Reflux Disease (eGERD) Who Achieved Endoscopically-confirmed Healing by 8 Weeks|"Healing at week 4 or 8 were based on improvement of eGERD of the Los Angeles (LA) classification of esophagitis Grade C or D from Baseline. Classifications include:
Not Present: No breaks (erosions) in the esophageal mucosa (however, edema, erythema, or friability may be present) Grade A: One or more mucosal breaks not more than 5mm in maximum length. Grade B: One or more mucosal breaks more than 5mm in maximum length, but not continuous between the tops of 2 mucosal folds.
Grade C: Mucosal breaks continuous between the tops of 2 or more mucosal folds, but involving less than 75% of the esophageal circumference.
Grade D: Mucosal breaks involving at least 75% of the esophageal circumference."|Baseline and Week 8|ITT Population - all randomized subjects who received at least 1 dose of study drug.||Percentage of Participants|||Number
762884|NCT00658775|Secondary|Percentage of Participants Who Achieved Diary-recorded Sustained Resolution of Heartburn by Week 4|During the first 4 weeks of the Double-blind Phase, participants were to record heartburn in a daily diary. Participant daily symptoms for the assessment of heartburn was based on a commonly used 4-point Likert scale of none, mild, moderate and severe. A participant was considered achieving sustained resolution of heartburn if the participant had maintained at least 7 consecutive heartburn-free days.|Week 4|ITT Population||Percentage of Participants|||Number
762885|NCT00658788|Secondary|Tolerability Assessment - Folliculitis||Baseline, 2, 4, 8 and 12 weeks|||participants|||Number
762886|NCT00658788|Secondary|Tolerability Assessment - Skin Atrophy||Baseline, 2, 4, 8 and 12 weeks|||participants|||Number
762887|NCT00658788|Secondary|Tolerability Assessment - Stinging/ Burning||Baseline, 2, 4, 8 and 12 weeks|||participants|||Number
762888|NCT00658788|Secondary|Tolerability Assessment - Telangiectasias||Baseline, 2, 4, 8 and 12 weeks|||participants|||Number
762889|NCT00658788|Secondary|Tolerability Assessment - Pruritus||Baseline, 2, 4, 8 and 12 weeks|||participants|||Number
762890|NCT00658788|Secondary|Overall Disease Severity||2, 4, 8 and 12 weeks|||participants|||Number
762891|NCT00658788|Secondary|Percent Change From Baseline in Body Surface Area (% BSA) Affected||2, 4, 8 and 12 weeks|||Percent Change from Baseline||Standard Deviation|Mean
762892|NCT00658788|Secondary|Signs of Psoriasis - Plaque Elevation||2, 4, 8 and 12 weeks|||participants|||Number
762893|NCT00658788|Secondary|Signs of Psoriasis - Scaling||2, 4, 8 and 12 weeks|||participants|||Number
762894|NCT00658788|Secondary|Signs of Psoriasis - Erythema||2, 4, 8 and 12 weeks|||participants|||Number
762895|NCT00658788|Secondary|Global Improvement Score||2, 4, 8 and 12 weeks|||participants|||Number
762896|NCT00658788|Primary|Overall Disease Severity Success (ODS)|Success was defined as a one-grade improvement in ODS from baseline.|8 and 12 weeks|The per protocol population included 170 subjects who completed the 12 week regimen without any major protocol deviations.||percentage of participants||95% Confidence Interval|Number
762901|NCT00658996|Primary|Contact Lens High Contrast Visual Acuity|VA measures at each scheduled visit were averaged to obtain an overall measure for each eye. A non-inferiority upper bound of 0.06 (3 letters) were used to assess the difference (Test – Control) in overall logMAR VA.|Over-all follow-up visits, 2 weeks|All eligible, dispensed eyes||LogMAR|Participants|Standard Deviation|Mean
765033|NCT00674154|Secondary|Increased Bone Mineral Density||One year||||||
765034|NCT00674154|Secondary|Increase in Quality of Life||One year||||||
762902|NCT00658996|Secondary|Slit Lamp Findings|Graded 0-4 where 0=none and 4=severe on measure of epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, superior tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates|Over-all follow-up visits, 2 weeks|All dispensed eyes, over all follow-up visits||Eyes|Participants||Number
762903|NCT00658996|Primary|Symptoms and Complaints|1-100 Scale for each eye. Zero represented the least favorable rating and 100 represented the most favorable.|Over-all follow-up visits for 2 week period|All eligible, dispensed eyes, Overall follow-up visits.||Scores on a Scale|Participants|Standard Deviation|Mean
762904|NCT00659061|Secondary|Percentage of Participants With Wasted Growth|Wasted defined as Weight for Height Z-score < -2SD|Baseline measurements taken at time of enrollment; Endline measurements taken 4-5 months post enrollment|those who had complete anthropometric measurements at endline||percentage of participants|||Number
762905|NCT00659061|Secondary|Percentage of Participants With Stunted Growth|Stunted defined as Height for Age Z-score < -2 standard deviation|Baseline measurements taken at time of enrollment; Endline measurments taken 4-5 months post enrollment|Those who had complete anthropometric measurements at endline||percentage of participants|||Number
762906|NCT00659061|Secondary|Percentage of Underweight Participants|Underweight defined as Weight for Age Z score < -2 standard deviation (SD)|Baseline measurements taken at time of enrollment; Endline measurements taken 4-5 months post enrollment|those who had complete baseline anthropometric measures||percentage of participants|||Number
762907|NCT00659061|Primary|Mean Hemoglobin of Participants Post Intervention||Endline Hb taken 4-5 months post enrollment|||g/dL||95% Confidence Interval|Mean
762908|NCT00659061|Primary|Number of Participants With Moderate to Severe Anemia|number of participants with moderate - severe anemia defined as Hb < 10g/dL|Baseline Hb taken at time of enrollment; Endline Hb taken 4-5 months post enrollment|||participants|||Number
762909|NCT00659061|Secondary|Mean Vitamin A Serum Retinol (ug]dl) Taken Post Intervention||Measurement taken 4-5 months post enrollment|||ug/dl||95% Confidence Interval|Mean
762910|NCT00659061|Secondary|Vitamin A Status of Participants - Post Intervention|Categorized as <20ug/dL; 20-40 ug/dL; >40 ug/dl|Measurement taken 4-5 months post enrollment|those who had endline assessment of serum vitamin A||participants|||Number
762911|NCT00659061|Primary|Number of Participants With Anemia|number with mild to severe anemia (hemoglobin(Hb)<11g/dL)|Baseline hemoglobin (Hb) taken at time of enrollment; Endline Hb taken 4-5 months post enrollment|||participants|||Number
762912|NCT00659165|Secondary|Serum Satiety Factors|Serum values of centrally acting mediators of satiety(Peptide YY, ghrelin, leptin).|measured at 3 points in time during each hospital admission: at admission, 10 minutes prior to study meal and 60 minutes following study meal||||||
762913|NCT00659165|Secondary|Resting Energy Expenditure|Determined by indirect calorimetry/metabolic cart measurement on the morning of inpatient admission.|performed once during each hospital admission||||||
762914|NCT00659165|Secondary|Food Diary|Food diaries were kept at home for one week prior to admission.|performed daily for each meal during the last week of treatment with each study insulin||||||
762915|NCT00659165|Secondary|24-hour Dietary Recall||performed once during each hospital admission||||||
762916|NCT00659165|Secondary|Satiety Scales|Collected at baseline, after 24 hours of fasting, and after eating.|performed at 3 points in time during each hospital admission: immediately upon hospital admission, and then again at 12 hours and 24 hours.||||||
762917|NCT00659165|Secondary|% Body Fat by Bioelectrical Impedance||Once during each hospital admission||||||
762918|NCT00659165|Primary|Calories Consumed During Test Meal After a 24 Hour Fast.|Total energy ingested following the 24 hour fast.|Measured after a 24 hour fast, after treatment with study insulin for at least 3 weeks|||kcal||Standard Deviation|Mean
762933|NCT00659360|Secondary|Duration of Response|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions;
Objective Tumor Response of more than 4 months was counted toward the Disease Control Rate."|Up to 5 years||||||
762923|NCT00659269|Primary|Change in Neurotoxicity Assessment Between Cycle 4 and Baseline|Neurotoxicity is evaluated using The Functional Assessment of Cancer Therapy-Taxane (FACT-Tax) questionnaire. FACT-Tax is a validated, self-reported instrument. The questionnaire consists of 11 questions and possible scores for each question range from 0 (no neurotoxicity symptoms) to 4 (worst possible neurotoxicity symptoms). The total score for any patient can therefore range from 0 to 44. The questionnaire is given to patients to fill out at baseline, cycle 2, and cycle 4 of their chemotherapy treatment. Change in neurotoxicity scores from baseline to the completion of 4 cycles are reported as the mean total score for all patients.|4 weeks|Of the 92 & 97 patients in the Multivitamin (MV) and MV + Vit.B12 + VitB6 arms, 54 & 62, respectively, in Group 1 (Taxanes) completed both 4 cycles of chemo and the FACT-Tax questionnaire at baseline and cycle 4; analysis is presented here. The same applies to 28 & 20 patients in Group 2 (Heavy Metals) and 5 & 9 patients in Group 3 (Vinca)||units on a scale||Standard Deviation|Mean
762924|NCT00659269|Primary|Neurotoxicity Assessment at Cycle 4|Neurotoxicity is evaluated using The Functional Assessment of Cancer Therapy-Taxane (FACT-Tax) questionnaire. FACT-Tax is a validated, self-reported instrument. The questionnaire consists of 16 questions and possible scores for each question range from 0 (no neurotoxicity symptoms) to 4 (worst possible neurotoxicity symptoms). The total score for any patient can therefore range from 0 to 44. The questionnaire is given to patients to fill out at completion of cycle 4 of their chemotherapy treatment and the mean total score for all patients is reported.|4 weeks|Of the 92 & 97 patients in the MV and MV + Vit.B12 + VitB6 arms, 57 & 65 patients, respectively, in Group 1 (Taxanes) completed both 4 cycles of chemotherapy and completed the FACT-Tax questionnaire at cycle 4, and the analysis is presented here. The same applies to 28 & 21 patients in Group 2 (Heavy Metals) and 6 & 9 patients in Group 3 (Vinca)||units on a scale||Standard Deviation|Mean
762925|NCT00659269|Primary|Neurotoxicity Assessment at Cycle 2|Neurotoxicity is evaluated using The Functional Assessment of Cancer Therapy-Taxane (FACT-Tax) questionnaire. FACT-Tax is a validated, self-reported instrument. The questionnaire consists of 11 questions and possible scores for each question range from 0 (no neurotoxicity symptoms) to 4 (worst possible neurotoxicity symptoms). The total score for any patient can therefore range from 0 to 44. The questionnaire is given to patients to complete at completion of cycle 2 of chemotherapy treatment and the mean total score for all patients is reported.|2 weeks|Of the 92 & 97 patients in the MV and MV + Vit.B12 + VitB6 arms, 72 & 80 patients, respectively, in the Group 1 (Taxanes) both completed 2 cycles of treatment and completed the FACT-Tax questionnaire at cycle 2, and the analysis is presented here. The same applies to 27 & 25 patients in Group 2 (Heavy Metals) and 9 & 10 patients in Group 3 (Vinca)||units on a scale||Standard Deviation|Mean
762926|NCT00659269|Primary|Neurotoxicity Assessment at Baseline|Neurotoxicity is evaluated using The Functional Assessment of Cancer Therapy-Taxane (FACT-Tax) questionnaire. FACT-Tax is a validated, self-reported instrument. The questionnaire consists of 11 questions and possible scores for each question range from 0 (no neurotoxicity symptoms) to 4 (worst possible neurotoxicity symptoms). The total score for any patient can therefore range from 0 to 44. The questionnaire is given to patients to fill out at baseline (prior to chemotherapy treatment) and the mean total score for all patients is reported.|At study start; prior to treatment (week 0)|Of the 92 and 97 patients in the MV arm and MV + Vit.B12 + VitB6 arm, 84 and 86 patients, respectively, in the Group 1 (Taxanes) completed the FACT-Tax questionnaire at baseline and the analysis is presented here. This also applies to 48 and 45 patients in Group 2 (Heavy Metals) and 10 and 12 patients in Group 3 (Vincas)||units on a scale||Standard Deviation|Mean
762927|NCT00659295|Primary|Incidence of Serious Adverse Reactions, Including Major Hypoglycaemic Events|The incidence of serious adverse reactions (SARs), including major hypoglycaemic events, during 3 months of insulin detemir therapy for all countries participating in the study, and during 6 and 12 months of insulin detemir therapy for some of the participating countries. The three sub-groups were mutually exclusive. Physicians did not report all major hypoglycaemic events as SARs. The values in the SAE table are SARs including only those major hypoglycaemic events that were reported as SARs by physicians.|Months 0-12|FAS (Full Analysis Set) consists of all patients with a baseline visit who were prescribed insulin detemir at least once||participants|||Number
762928|NCT00659334|Secondary|Compare Pre- and Post-op Gd Enhanced MRI Combidex Enhanced MR Imaging Done Pre-, Intra- and Post-operatively, to Assess the Degree of Resection and Residual Tumor.||2 years||||||
762929|NCT00659334|Secondary|Compare Combidex Imaging in Brain Tumor Patients, With Other CNS Inflammatory Lesions Such as Multiple Sclerosis and Stroke.||2 years||||||
762930|NCT00659334|Secondary|Assess the Cellular Uptake of Particles in Brain Tumor Patients by Comparing Imaging Results With Histology and Electron Microscopic Examination of Biopsy Tissue||2 years||||||
762931|NCT00659334|Primary|Number of Participants Who Experience Optimal Imaging in Adult and Pediatric Brain Tumors to Establish Timing and Sequencing Parameters of Combidex.|Signal intensity change in participants with Pre and 24 hours Post Combidex on T1, T2, T2* MRI sequences will be assessed (some patients undergo scans at 3 and 72 hours in order to assess radiographic changes at these time points). Combidex will be administered in dose 2.6 mg/kg in adults with high and low grade gliomas, metastases, meningiomas, and PNET; and in pediatric patients with astrocytomas grade i-iv, brain stem gliomas, ependymomas, CNS germ cell tumors, and PNET.|24 hours (some patients between 3 and 72 hours) after administration of Combidex|||Participants|||Number
762932|NCT00659360|Secondary|Time to Disease Progression|"The Kaplan-Meier method will be used to estimate time to progression estimates.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions."|Up to 5 years|||months||95% Confidence Interval|Median
762937|NCT00659360|Primary|Disease Control Rate, Defined as the Number of Patients Who Achieved Complete Response, Partial Response or Stable Disease For a Period of More Than 4 Months.|Response and progression will be evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Changes in only the largest diameter (unidimensional measurement) of the tumor lesions; where CR is disappearance of all target lesions, PR is at least 30% decrease in the sum of longest diameter, PD is at least 20% increase in the sum of longest diameter recorded since the treatment started and SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD|Up to 5 years|||participants|||Number
762938|NCT00659373|Primary|Change in Cognitive Function Over 1 Year in Premenopausal Breast Cancer Patients Who Receive Adjuvant Tamoxifen (T) Alone Against Those Receive Adjuvant Tamoxifen (T+OFS) or Exemestane (E+OFS) With Ovarian Function Suppression (OFS)|Objective cognitive function measured with CogState, a computerized test battery of 7 tasks: Detection, Identification, Monitoring, Memory, Learning, International Shopping List Task (ISLT) and ISLT-Delayed Recall. Performance speed is measured for Detection/Identification/Monitoring and performance accuracy is measured for Memory/Learning/ISLT/ISLT-Delayed Recall. Performance speed calculated as mean of the log10 transformed reaction time for correct responses (lower score=better); performance accuracy calculated as arcsine transformation of the proportion of correct responses (higher scores=better). Main outcome measure is a composite score (average of task scores after transformation and standardization by age-specific norms). A positive standardized score indicates that a patient performed better than average; a negative standardized score indicates below average results. Patients complete assessments at baseline and 1 year after randomization to parent IBCSG 24-02 (SOFT) study.|1 year after patient randomization to parent IBCSG 24-02 study|||standardized units||Standard Deviation|Mean
762939|NCT00659425|Secondary|Number of Participants With Potential Biomarkers of Predicting Capillary Leak Syndrome (CLS)|Potential biomarkers include orthostatic blood pressure, albumin levels, weight change, edema and hypoxia were evaluated.|Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment)|Safety population included all participants who received any treatment of study drug.||participants|||Number
762940|NCT00659425|Secondary|CD22 Expression Cells in Peripheral Blood by Best Response|Participants malignant cells (peripheral blood) was tested for cluster of differentiation 22 (CD22) expression by fluorescence-activated cell sorter (FACS) analysis.|Baseline until end of treatment (up to 1 year after the last participant begins study drug treatment)|Safety population included all participants who received any treatment of study drug. Here, n = participants evaluable for specified category for each arm, respectively||sites per cell||Full Range|Median
762941|NCT00659425|Secondary|Number of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibody|Participants tested for immunogenicity to CAT-8015 (moxetumomab pasudotox) prior to enrollment, before each cycle and at end of study. The neutralization assay measures the capacity of participant's plasma (antibodies) to inhibit the binding of moxetumomab pasudotox to its target, cluster of differentiation 22 (CD22), coated onto enzyme linked immunosorbent assay (ELISA) plates. It was used as a direct surrogate for biological activity based on the mechanism of action of this drug. Significant level of neutralizing antibody activity defined as the capacity of test plasma to inhibit greater than (>)50 percentage (%) of the binding of CAT-8015 to CD22 using an ELISA-based method.|Baseline until end of treatment (up to 1 year after the last participant begins study drug treatment)|Safety population included all participants who received any treatment of study drug.||Participants|||Number
762942|NCT00659425|Primary|Terminal Phase Elimination Half Life (t1/2) for Moxetumomab Pasudotox|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Cycles 1, 2 and every 4th cycle: pre-dose, end of infusion (EOI), 1, 1.5, 2.5, 4 and 8 hours post-dose of Dose 1; pre-dose and end of infusion after Dose 6|Evaluable Population for Efficacy included all participants who received any treatment of study drug and had at least 1 disease assessment after the initiation of study drug.||hour (h)||Standard Deviation|Mean
762943|NCT00659425|Primary|Systemic Clearance (CL) for Moxetumomab Pasudotox|The CL is a quantitative measure of the rate at which a drug substance is removed from the body. The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by the plasma area under the plasma concentration-time curve from time zone to infinite time (AUC[0-infinity]).|Cycles 1, 2 and every 4th cycle: pre-dose, end of infusion (EOI), 1, 1.5, 2.5, 4 and 8 hours post-dose of Dose 1; pre-dose and end of infusion after Dose 6|Evaluable Population for Efficacy included all participants who received any treatment of study drug and had at least 1 disease assessment after the initiation of study drug.||milliliter per hour per kilogram||Standard Deviation|Mean
762944|NCT00659425|Primary|Area Under the Serum Concentration Time Curve From Time Zero to Infinity (AUC [0 to Infinity]) for Moxetumomab Pasudotox|The AUC (0 to infinity) is the area under the plasma concentration-time curve from time zero to infinity hours.|Cycles 1, 2 and every 4th cycle: pre-dose, end of infusion (EOI), 1, 1.5, 2.5, 4 and 8 hours post-dose of Dose 1; pre-dose and end of infusion after Dose 6|Evaluable Population for Efficacy included all participants who received any treatment of study drug and had at least 1 disease assessment after the initiation of study drug.||hour*nanogram per milliliter (h.ng/mL)||Standard Deviation|Mean
762945|NCT00659425|Primary|Maximum Observed Serum Concentration (Cmax) for Moxetumomab Pasudotox|The Cmax is the maximum observed plasma concentration of Moxetumomab Pasudotox.|Cycles 1, 2 and every 4th cycle: pre-dose, end of infusion (EOI), 1, 1.5, 2.5, 4 and 8 hours post-dose of Dose 1; pre-dose and end of infusion after Dose 6|Evaluable Population for efficacy included all participants who received any treatment of study drug and had at least 1 disease assessment after the initiation of study drug.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
762946|NCT00659425|Primary|Overall Survival (OS)|Overall survival was determined as the time from the start of treatment with Moxetumomab Pasudotox until death. Number of deaths were reported here.|Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment)|"Evaluable Population for Efficacy included all participants who received any treatment of moxetumomab pasudotox and had at least 1 disease assessment after the initiation of moxetumomab pasudotox. Here, N is number of participants analyzed for this outcome measure."||months||Full Range|Median
762998|NCT00659581|Secondary|Change From Baseline in Systolic Blood Pressure at 36 Months||initiation and 36 months|The 8267 patients with insufficient study medication adherence, no measured systolic blood pressure in the period, or discontinued before 36 months were excluded.||mmHg||Standard Deviation|Mean
765035|NCT00674154|Secondary|Reduced Postoperative Hypocalcemia||Postoperative week||||||
762947|NCT00659425|Primary|Progression-Free Survival (PFS)|Progression-free survival was measured from the start of treatment with moxetumomab pasudotox until the documentation of disease progression or death due to any cause, whichever occurs first. Number of progressions/deaths were reported here.|Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment)|"Evaluable Population for Efficacy included all participants who received any treatment of moxetumomab pasudotox and had at least 1 disease assessment after the initiation of moxetumomab pasudotox. Here, N is number of participants analyzed for this outcome measure."||months||Full Range|Median
762948|NCT00659425|Primary|Time to Disease Progression (TDP)|Time to disease progression was measured from the start of treatment with moxetumomab pasudotox until the documentation of disease progression. Number of progressions were reported here.|Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment|"Evaluable Population for Efficacy included all participants who received any treatment of moxetumomab pasudotox and had at least 1 disease assessment after the initiation of moxetumomab pasudotox. Here, N is number of participants analyzed for this outcome measure."||months||Full Range|Median
762949|NCT00659425|Primary|Duration of Response (DR)|Duration of response was defined as the duration from the first documentation of objective response to the first documented disease progression.|Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment|Evaluable Population for Efficacy. Here, “N” is number of participants with objective disease response in the respective cohort. DR could not be estimated as none of the participants experienced OR in the 5 mcg/kg, 20 mcg/kg (schema A) and 30 mcg/kg (schema A).||months||Full Range|Median
762950|NCT00659425|Primary|Time to Disease Response|Time to disease response was measured from the start of moxetumomab pasudotox administration to the first documentation of response (CR or PR) and was assessed in participants who achieved objective response.|Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment)|Evaluable Population for Efficacy. Here, “N” is number of participants with objective disease response in the respective cohort. Time to disease response could not be estimated as none of the participants experienced OR in the 5 mcg/kg, 20 mcg/kg (schema A) and 30 mcg/kg (schema A).||months||Full Range|Median
762951|NCT00659425|Primary|Percentage of Participants With Relapse of Disease|Relapse is defined as progressive disease (PD) following complete response (CR). Rate of relapse was only calculated for the subgroup of participants with complete response.|Baseline until end of treatment (up to 1 year after the last participant begins study drug treatment)|Efficacy population. Here, “N” is number of participants with CR in the respective cohort. Rate of relapse could not be estimated as none of the participants experienced CR in the 5 mcg/kg, 20 mcg/kg (Schema A) and 30 mcg/kg (schema A) cohort of the study.||percentage of participants|||Number
762952|NCT00659425|Primary|Objective Response Rate (ORR)|Objective response based on assessment of confirmed composite complete response (CRc) or partial response (PR) according to disease specific criteria [modified criteria for response in acute lymphoblastic leukemia (ALL)].|Baseline until end of treatment (up to 1 year after the last participant begins study drug treatment)|"Efficacy population included all participants who received any treatment of study drug and had at least 1 disease assessment after the initiation of study drug. Here, N is number of participants analyzed for this outcome measure."||percentage of participants|||Number
762953|NCT00659425|Primary|Best Overall Tumor Response|Antitumor activity was assessed by best overall tumor response.|Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment)|"Evaluable Population for Efficacy included all participants who received any treatment of moxetumomab pasudotox and had at least 1 disease assessment after the initiation of moxetumomab pasudotox. Here, N is number of participants analyzed for this outcome measure."||Participants|||Number
762954|NCT00659425|Primary|Change From Baseline to End of Treatment in Clinical Findings in Electrocardiogram (ECG) QT, QTC Interval and Ventricular Rate|The 12-lead ECG data were summarized and evaluated for the following parameters: ,QT, QTC intervals and ventricular rate. Change from baseline in these parameters were reported.|Baseline and end of treatment (up to 1 year after the last participants begins study drug treatment)|Safety population included all participants who received any treatment of study drug.||milli seconds (msec)||Standard Deviation|Mean
762955|NCT00659425|Primary|Number of Participants With Change From Baseline in Normal Sinus Rhythm Findings in ECG|Number of participants with abnormal ECG changes (compared with baseline) as assessed by study cardiologist|Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment)|Safety population included all participants who received any treatment of study drug.||participants|||Number
762956|NCT00659425|Primary|Number of Participants With Abnormalities in Ophthalmologic Examination at End of Treatment That Were Not Present at Baseline|Ophthalmologic examination included evaluation of retinal, corneal and lens abnormalities at baseline and end of treatment that were not present at screening. Participants who experienced abnormalitities during ophthalmologic examination recorded and reported.|Baseline and end of treatment (up to 1 year after the last participants begins study drug treatment)|Safety population included all participants who received any treatment of study drug.||Participants|||Number
762957|NCT00659425|Primary|Treatment-Emergent Adverse Events (TEAEs) Related to Chemistry Abnormalities Occurring in Greater Than (>) 5 Percent of Participants|An abnormal chemistry finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Treatment-emergent were events between first dose of study drug and 30 days after the last dose that were absent before treatment or that worsened relative to pretreatment state.|From start of study drug administration up to 30 days after the last dose of study drug|Safety population included all participants who received any treatment of study drug.||Participants|||Number
762970|NCT00659438|Primary|Prostate Specific Antigen (PSA) Progression Free Rate at 4 Months|"To assess the effect of vandetanib on biological progression free rate based on PSA level (assessable set).
PSA progression free rate defined as the number of participants with :
After decline from baseline: a 25% increase above the nadir
No decline from baseline: a 25% increase above the baseline (min. increase of 2 ng/mL)"|4 months|||Participants|||Number
762999|NCT00659581|Secondary|Change From Baseline in Diastolic Blood Pressure at 24 Months||initiation and 24 months|The 6544 patients with insufficient study medication adherence, no measured diastolic blood pressure in the period, or discontinued before 24 months were excluded.||mmHg||Standard Deviation|Mean
765036|NCT00674154|Secondary|Improved Muscular Function||One Year||||||
762958|NCT00659425|Primary|Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)|An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Treatment-emergent were events between first dose of study drug and 30 days after the last dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with grade 3 or higher treatment-emergent adverse events (5% cut off) for laboratory abnormalities were reported as clinically relevant laboratory changes.|From start of study drug administration up to 30 days after the last dose of study drug|Safety population included all participants who received any treatment of study drug.||Participants|||Number
762959|NCT00659425|Primary|Number of Participants With Vital Signs Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)|Vital signs included parameters as heart rate, blood pressure, temperature, weight, pulse oximetry and respiratory rate. TEAEs were events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug, for the period extending to 30 days after the last dose of study drug.|From start of study drug administration until 30 days after the last dose of study drug|Safety Population included all participants who received any treatment of study drug.||Participants|||Number
762960|NCT00659425|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received investigational product. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of investigational product and 30 days after the last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state.|From start of study drug administration until 30 days after the last dose of study drug|Safety Population included all participants who received any treatment of study drug.||Participants|||Number
762961|NCT00659425|Primary|Number of Participants With Dose Limiting Toxicities (DLTs)|Adverse events that were suspected of a relationship to moxetumomab pasudotox and were greater than or equal to (>=) Grade 3 in severity were considered DLTs with the following additional criteria or exceptions: Participants with hematologic abnormalities of any grade, Grade 2 allergic reactions of bronchospasm or urticaria, or any Grade ≥ 3 allergic reaction, in the presence of premedication.|Day 1 up to 21 days of Cycle 1 (each cycle duration was of 21 days)|"Evaluable Population for DLT included all participants who received any treatment of moxetumomab pasudotox (CAT-8015) and completed the DLT period without a DLT, or did not complete the DLT period due to a DLT. Here, N is number of participants evaluated for this outcome measure."||participants|||Number
762962|NCT00659438|Secondary|Number of Patients With CECs, CTCs and Gene Signature Profile of CTCs|"To investigate the relationship between response to vandetanib, CTCs and CECs. To investigate gene signature profile of antiangiogenic response by gene micro-array analysis of CTCs.
Gene signature profile of CTCs was aimed to be compared before and after 2 months of treatment. No blood sample has been taken for the study, and so results on CTCs, CECs of tumour vessels and gene and signature profiles of CTCs were not performed."|4 months||||||
762963|NCT00659438|Secondary|Number of Circulating Endothelial Cells (CEC) of Tumour Blood Cells (in Patients Included in Ile de France Centres Only)|"To investigate the effect of vandetanib on CEC. Numbering of CECs was to be performed at baseline, 1 week, 1 month and 2 months after randomisation.
Correlation between the number of CECs and PSA response was to be estimated after 1 week, 1 month and 2 months of treatment."|4 months|This part of the study was proposed only to patients followed in one study centre located in Ile de France and finally no blood sample has been taken at this centre. So no data on CTCs, CECs were collected and no analysis was performed.|||||
762964|NCT00659438|Secondary|Number of Circulating Tumour Cells (CTC) (in Patients Included in Ile de France Centres Only)|"To investigate the effect of vandetanib on CTC. Numbering of CTCs to be performed at baseline, 1 week, 1 and 2 months after randomisation. This study was proposed only to patients followed in a study centre located in Ile de France.
Correlation between the number of CTCs and PSA response was to be estimated after 1 week, 1 and 2 months of treatment"|4 months|This part of the study was proposed only to patients followed in one study centre located in Ile de France and finally no blood sample has been taken at this centre. So no data on CTCs, CECs were collected and no analysis was performed.|||||
762965|NCT00659438|Secondary|Progression Rate From the Radionuclide Bone Scanning|To describe the effect of vandetanib on progression rate from the radionuclide bone scanning in a sub-group of patients who had a bone scan within 3 to 6 months after 1st treatment dose. Number of participants with at least 2 new lesions on the radionuclide bone scan compared to baseline assessment were counted for calculation of progression rate.|4 months|||Participants|||Number
762966|NCT00659438|Secondary|Overall Survival (OS)|To investigate the effect of vandetanib on overall survival. Patients alive at the time of the statistical analysis were censored at the time they were last known to be alive. Due to censored data, median overall survival in the placebo group cannot be calculated. OS defined as the number of participants who were alive.|End of study (July 2011)|||participants|||Number
762967|NCT00659438|Secondary|PSA Response Rate|"To investigate the effect of vandetanib on the PSA response rate. PSA response rate defined by the number of participants with a PSA decrease relative to baseline of at least 50%.
A minimum decrease of 2 ng/mL in absolute value and a confirmation on at least 2 consecutive occasions (at least 4 weeks apart) were requested."|4 months|||Participants|||Number
762968|NCT00659438|Secondary|Progression Free Survival (PFS) at 4 Months (Instead of Time to Onset of Cancer-related Symptoms)|Due to the difficulties to assess biological progression date when clinical progression has occurred first, and because of the non-assessment of the clinical progression after treatment discontinuation, Time to onset of cancer-related symptoms was not evaluated. PFS was evaluated instead, whether biological or clinical progression.|4 months|||weeks||95% Confidence Interval|Median
762969|NCT00659438|Secondary|Progression Free Survival (PFS) at 4 Months (Instead of Time to PSA Progression)|Due to the difficulties to assess biological progression date when clinical progression has occurred first, and because of the non-assessment of the clinical progression after treatment discontinuation, Time to PSA progression was not evaluated. PFS was evaluated instead, whether biological or clinical progression.|4 months|||weeks||95% Confidence Interval|Median
762971|NCT00659490|Secondary|Time to Max Deterioration in VAMS Down|Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from ‘not at all’ on the left end of the scale to ‘extremely’ on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry.|Between dosing and 12h post-dose|Only patients reporting a deterioration are included.The analyses are based on a per-protocol population.||minutes||Standard Deviation|Mean
762972|NCT00659490|Secondary|Time to Max Deterioration in VAMS Sedated|Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from ‘not at all’ on the left end of the scale to ‘extremely’ on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry.|Between dosing and 12h post-dose|Only patients reporting a deterioration are included.The analyses are based on a per-protocol population.||minutes||Standard Deviation|Mean
762973|NCT00659490|Secondary|Time to Max Deterioration in VAMS Anxious|Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from ‘not at all’ on the left end of the scale to ‘extremely’ on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry.|Between dosing and 12h post-dose|Only patients reporting a deterioration are included.The analyses are based on a per-protocol population.||minutes||Standard Deviation|Mean
762974|NCT00659490|Secondary|Time to Max Deterioration in VAMS High|Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from ‘not at all’ on the left end of the scale to ‘extremely’ on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry.|Between dosing and 12h post-dose|Only patients reporting a deterioration are included.The analyses are based on a per-protocol population.||minutes||Standard Deviation|Mean
762975|NCT00659490|Secondary|Time to Max Deterioration in VAMS Stimulated|Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from ‘not at all’ on the left end of the scale to ‘extremely’ on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry.|Between dosing and 12h post-dose|Only patients reporting a deterioration are included.The analyses are based on a per-protocol population.||Minutes||Standard Deviation|Mean
762976|NCT00659490|Secondary|Maximum Deterioration in VAMS Down|Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from ‘not at all’ on the left end of the scale to ‘extremely’ on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry.|Between dosing and 12h post-dose|Only patients reporting a deterioration are included. The analyses are based on a per-protocol population.||mm||Standard Deviation|Mean
762977|NCT00659490|Secondary|Maximum Deterioration in VAMS Sedated|Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from ‘not at all’ on the left end of the scale to ‘extremely’ on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry.|Between dosing and 12h post-dose|Only patients reporting a deterioration are included.The analyses are based on a per-protocol population.||mm||Standard Deviation|Mean
762978|NCT00659490|Secondary|Maximum Deterioration in VAMS Anxious|Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from ‘not at all’ on the left end of the scale to ‘extremely’ on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry.|Between dosing and 12h post-dose|Only patients reporting a deterioration are included.The analyses are based on a per-protocol population.||mm||Standard Deviation|Mean
762979|NCT00659490|Secondary|Maximum Deterioration in VAMS High|Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from ‘not at all’ on the left end of the scale to ‘extremely’ on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry.|Between dosing and 12h post-dose|Only patients reporting a deterioration are included.The analyses are based on a per-protocol population.||mm||Standard Deviation|Mean
763023|NCT00652145|Secondary|Fecal Calprotectin Level <100 µg/g||at 6 weeks after randomization|38 participants with baseline FC>=100ug/g||participants|||Number
762980|NCT00659490|Secondary|Maximum Deterioration in Visual Analogue Mood Scale (VAMS) Stimulated|Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from ‘not at all’ on the left end of the scale to ‘extremely’ on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry.|Between dosing and 12h post-dose|Only patients reporting a deterioration are included.The analyses are based on a per-protocol population.||mm||Standard Deviation|Mean
762981|NCT00659490|Secondary|Number of Patients Requesting Rescue Medication|Observed case.|End of surgery up to 8hours following surgery|The analyses are based on a per-protocol population.||Participants|||Number
762982|NCT00659490|Secondary|Time to First Intake of Rescue Medication.||From end of surgery to 8 hours following surgery|Only patients actually taking rescue medication are included in analysis.||Hours||Standard Deviation|Mean
762983|NCT00659490|Secondary|Pain at Jaw Movement at Time of First Rescue Medication|"Pain at jaw movement at time of first rescue medication (VAS 0-100mm). Observed case.
Pain at jaw movement at time of first rescue medication (VAS 0-100mm, 0 = no pain - 100 = worst pain imaginable)."|At time of first rescue medication (before 8 hours after end on surgery)|Only patients taking rescue are included in analysis. The analyses are based on a per-protocol population.||mm||Standard Deviation|Mean
762984|NCT00659490|Secondary|Pain at Rescue Medication|"Pain at time of first rescue medication (VAS 0-100mm). Only patients taking rescue are included in analysis. Observed case.
Pain at time of first rescue medication (VAS 0-100mm, 0 = no pain - 100 = worst pain imaginable)."|At time of first rescue medication taken before 8 hours after end of surgery|Only patients taking rescue are included in analysis. The analyses are based on a per-protocol population.||mm||Standard Deviation|Mean
762985|NCT00659490|Secondary|Mean Pain at Jaw Movement|Calculated as the area under the Visual Analogue Pain Scale (0-100 mm) of jaw movement versus time curve divided by time. Missing values in the pain-by-time curve was imputated using linear interpolation, last observation carried forward (LOCF) or first observation carried backwards (FOCB) as applicable. Mean Pain at jaw movement VAS (0-100mm, 0 = no pain - 100 = worst pain imaginable ).|From end of surgery to 8h or time to first intake of rescue medication (whichever came first)|The analyses based on a per-protocol population.||mm||Standard Deviation|Mean
762986|NCT00659490|Secondary|Maximum Pain at Jaw Movement|"Maximum pain at jaw movement recorded on a Visual Analogue Scale, VAS (0-100mm). Observed case.
Maximum Pain at jaw movement VAS (0-100mm, 0 = no pain - 100 = worst pain imaginable)"|From end of surgery to 8h or time to first intake of rescue medication (whichever came first)|The analyses based on a per-protocol population.||mm||Standard Deviation|Mean
762987|NCT00659490|Secondary|Pain at Jaw Movement AUC0-4h|Area under the Visual Analogue Scale (VAS, 0-100 mm) of jaw movement versus time curve 0-4h (from end of surgery). Missing values in the pain-by-time curve was imputated using linear interpolation, last observation carried forward (LOCF) or first observation carried backwards (FOCB) as applicable. Area under the curve 0-4h (from end of surgery) of VAS pain at jaw movement (0-100mm0 = no pain - 100 = worst pain imaginable).|0-4h after end of surgery to 4 hours post surgery|The analyses based on a per-protocol pop.||mm*h||Standard Deviation|Mean
762988|NCT00659490|Secondary|Pain at Jaw Movement AUC0-8h|Area under the Visual Analogue Scale (VAS, 0-100 mm) of jaw movement versus time curve 0-8h (from end of surgery). Missing values in the pain-by-time curve was imputated using linear interpolation, last observation carried forward (LOCF) or first observation carried backwards (FOCB) as applicable. Area under the curve 0-8h (from end of surgery) of VAS pain at jaw movement (0-100mm, 0 = no pain - 100 = worst pain imaginable)|0-8h from end of surgery to 8 hours post surgery|The analyses based on a per-protocol pop.||mm*h||Standard Deviation|Mean
762989|NCT00659490|Secondary|Mean Pain Based on a VAS Scale|Calculated as the area under the Visual Analogue Pain Scale (0-100 mm) versus time curve divided by time.Missing values in the pain-by-time curve was imputated using linear interpolation, last observation carried forward (LOCF) or first observation carried backwards (FOCB) as applicable. Mean pain VAS (0-100mm, 0 = no pain - 100 = worst pain imaginable)|From end of surgery to 8h or time to first intake of rescue medication (whichever came first)|The analyses based on a per-protocol population.||mm||Standard Deviation|Mean
762990|NCT00659490|Secondary|Maximum Pain Based on VAS Scale|"Maximum pain recorded on a Visual Analogue Scale, VAS (0-100mm). Observed case.
Maximum pain VAS (0-100mm, 0 = no pain - 100 = worst pain imaginable)"|From end of surgery to 8h or time first intake of rescue medication (whichever came first)|The analyses based on a per-protocol population.||mm||Standard Deviation|Mean
762991|NCT00659490|Secondary|Pain Area Under the VAS Versus Time Curve 0-4h (AUC0-4h)|Area under the Visual Analogue Scale (VAS, 0-100 mm) time curve 0-4h (from end of surgery). Missing values in the pain-by-time curve was imputated using linear interpolation, last observation carried forward (LOCF) or first observation carried backwards (FOCB) as applicable.|0-4h (from end of surgery to 4 hours post surgery)|The analyses based on a per-protocol population.||mm*h||Standard Deviation|Mean
762992|NCT00659490|Primary|Pain Area Under the Curve 0-8h (AUC0-8h)|Area under the Visual Analogue Scale (VAS, 0-100 mm) time curve 0-8h (from end of surgery). Missing values in the pain-by-time curve was imputated using linear interpolation, last observation carried forward (LOCF) or first observation carried backwards (FOCB) as applicable.|0-8 h(from end of surgery to 8 hours post surgery)|The analyses based on a per-protocol population.||mm*h||Standard Deviation|Mean
762993|NCT00659529|Secondary|Serum Sildenafil Levels||Pre/during therapy||||||
762994|NCT00659529|Secondary|CFQ-R||Pre/post therapy||||||
762995|NCT00659529|Secondary|Exhaled Breath Condensate pH||Pre/post therapy||||||
762996|NCT00659529|Primary|Sputum Elastase||Pre/post therapy|Subjects who completed 6 weeks of sildenafil and had available data for pre/post 6 weeks of sildenafil were analyzed. One subject presented to the final study visit with 1 week of previously unreported symptoms consistent with pulmonary exacerbation, and therefore, efficacy data was not analyzed on that subject as pre-specified in the protocol.||micrograms/mL||95% Confidence Interval|Mean
762997|NCT00659581|Secondary|Change From Baseline in Diastolic Blood Pressure at 36 Months||initiation and 36 months|The 8270 patients with insufficient study medication adherence, no measured diastolic blood pressure in the period, or discontinued before 36 months were excluded.||mmHg||Standard Deviation|Mean
763000|NCT00659581|Secondary|Change From Baseline in Systolic Blood Pressure at 24 Months||initiation and 24 months|The 6544 patients with insufficient study medication adherence, no measured systolic blood pressure in the period, or discontinued before 24 months were excluded.||mmHg||Standard Deviation|Mean
763001|NCT00659581|Secondary|Change From Baseline in Diastolic Blood Pressure at 12 Months||initiation and 12 months|The 4400 patients with insufficient study medication adherence, no measured diastolic blood pressure in the period, or discontinued before 12 months were excluded.||mmHg||Standard Deviation|Mean
763002|NCT00659581|Secondary|Change From Baseline in Systolic Blood Pressure at 12 Months||initiation and 12 months|The 4400 patients with insufficient study medication adherence, no measured systolic blood pressure in the period, or discontinued before 12 months were excluded.||mmHg||Standard Deviation|Mean
763003|NCT00659581|Secondary|Change From Baseline in Diastolic Blood Pressure at 6 Months||initiation and 6 months|The 2506 patients with insufficient study medication adherence, no measured diastolic blood pressure in the period, or discontinued before 6 months were excluded.||mmHg||Standard Deviation|Mean
763004|NCT00659581|Secondary|Change From Baseline in Systolic Blood Pressure at 6 Months||initiation and 6 months|The 2503 patients with insufficient study medication adherence, no measured systolic blood pressure in the period, or discontinued before 6 months were excluded.||mmHg||Standard Deviation|Mean
763005|NCT00659581|Primary|Number of Patients With Cerebrovascular(CeV) and Cardiovascular (CaV) Events||3 years after initiation of treatment|All of observed 20,443 patients were included as intention to treat set||Number of participants|||Number
763006|NCT00659607|Secondary|Daily Dose of Micardis® Plus Factors Affecting the Efficacy Profile|"Efficacy rate by medical characteristic of patients
40/12.5mg < daily dose < 80/12.5mg - Because some physicians changed the daily dose based on patient’s BP control result, this range exists"|Baseline and End of Study|Out of 6,901 patients, 3,616 patients for the efficacy assessment and Daily dose not recorded for 26 patients||Percentage of patients|||Number
763007|NCT00659607|Secondary|Baseline Severity of Hypertension Factors Affecting the Efficacy Profile|"Efficacy rate by medical characteristic of patients
Stage 1 (SBP 140~159 mmHg or DBP 90~99 mmHg) Stage 2 (SBP 160~179 mmHg or DBP 100~109 mmHg) Stage 3 (SBP ≥ 180 mmHg or DBP ≥ 110 mmHg)"|Baseline and End of Study|Out of 6,901 patients, 3,616 patients for the efficacy assessment||Percentage of patients|||Number
763008|NCT00659607|Secondary|Previous Medication Factors Affecting the Efficacy Profile|Efficacy rate by medical characteristic of patients|Baseline and End of Study|Out of 6,901 patients, 3,616 patients for the efficacy assessment||Percentage of patients|||Number
763009|NCT00659607|Secondary|Medical History Factors Affecting the Efficacy Profile|Efficacy rate by medical characteristic of patients|Baseline and End of Study|Out of 6,901 patients, 3,616 patients for the efficacy assessment||Percentage of patients|||Number
763010|NCT00659607|Secondary|Concomitant Disease Factors Affecting the Safety Profile|Occurrence status of adverse events by Concomitant disease of patients|Up to 6 years|Out of 6,901 patients, 3,932 patients were analyzed for the safety assessment||Percentage of patients||95% Confidence Interval|Number
763011|NCT00659607|Secondary|Medical History Factors Affecting the Safety Profile|Occurrence status of adverse events by medical history of patients|Up to 6 years|Out of 6,901 patients, 3,932 patients were analyzed for the safety assessment||Percentage of patients||95% Confidence Interval|Number
763012|NCT00659607|Primary|Effective Rate|"Efficacy assessment (effective or not effective) based on a clinical judgement (1=Cured, 2=Improved, 3=Failed) as follows:
Ⅰ. Effective (if the clinical judgement of investigator is 1 or 2=cured or improved)
Ⅱ. Not effective (if the clinical judgement of investigator is 3=failed)"|Baseline and End of Study|Out of 6,901 patients, 3,616 patients for the efficacy assessment||Percentage of patients|||Number
763013|NCT00659607|Primary|Change From Baseline in DBP (Diastolic Blood Pressure) at Week 2|Effect on decrease in diastolic blood pressure|Baseline and End of Study|Out of 6,901 patients, 3,616 patients for the efficacy assessment||mmHg||Standard Deviation|Mean
763014|NCT00659607|Secondary|Treatment Type Factors Affecting the Safety Profile|Occurrence status of adverse events by Treatment type of patients|Up to 6 years|Out of 6,901 patients, 3,932 patients were analyzed for the safety assessment and Treatment type not recorded for 294 patients||Percentage of patients||95% Confidence Interval|Number
763015|NCT00659607|Secondary|Proportion of Geriatric Population Factor Affecting the Safety Profile|Occurrence status of adverse events by Proportion of geriatric population of patients|Up to 6 years|Out of 6,901 patients, 3,932 patients were analyzed for the safety assessment and Date of birth not recorded for 15 patients||Percentage of patients||95% Confidence Interval|Number
763016|NCT00659607|Secondary|Age Factors Affecting the Safety Profile|Occurrence status of adverse events by Age category of patients|Up to 6 years|Out of 6,901 patients, 3,932 patients were analyzed for the safety assessment and Date of birth not recorded for 15 patients||Percentage of patients||95% Confidence Interval|Number
763017|NCT00659607|Secondary|Gender Factors Affecting the Safety Profile|Occurrence status of adverse events by Gender category of patients|Up to 6 years|Out of 6,901 patients, 3,932 patients were analyzed for the safety assessment and Gender not recorded for 15 patients||Percentage of patients||95% Confidence Interval|Number
763018|NCT00659607|Primary|Change From Baseline in SBP (Systolic Blood Pressure) at Week 2|Effect on decrease in systolic blood pressure|Baseline and End of Study|Out of 6,901 patients, 3,616 patients for the efficacy assessment||mmHg||Standard Deviation|Mean
763019|NCT00659607|Primary|Frequency of Adverse Events||Up to 6 years|Out of 6,901 patients, 3,932 patients were analyzed for the safety assessment||Percentage of patients|||Number
763020|NCT00659607|Primary|Unexpected Adverse Events|Occurrence status of unexpected adverse events|Up to 6 years|Out of 6,901 patients, 3,932 patients were analyzed for the safety assessment||Percentage of patients|||Number
763021|NCT00659633|Primary|Pain Perception|"Assessing heat pain perception (pain intensity) before, during, and after lidocaine infusion by means of patient self-report using a mechanical slide algometer.
The mechanical slide algometer [Price et al. (1994)] looks like a ruler that exposes a red bar with the end-points: no pain (left) and most pain imaginable (right). The use the slider to express their perceived pain. On the back of the ruler a numerical scale ranging from 0 (no pain) to 10 (worst imaginable pain) translates the patient's rating into a numeric scale."|Participants will be followed from baseline through 128 minutes|||units on a scale||Standard Error|Mean
763022|NCT00652145|Secondary|Fecal Calprotectin <200 µg/g||at 6 weeks after randomization|25 participants with baseline FC>=200ug/g||participants|||Number
763025|NCT00659724|Primary|Dialyzer Assessment: Venous Header Condition|"For every study treatment/dialyzer, the nursing staff rated the condition of the venous header after rinse-back as follows:
Very Good:Surface as clean as expected. Good:Distinct red ring appears at the dialyzer wall. Poor:Significant appearance of clots, randomly distributed on the surface. Very Poor:Completely red and/or covered with clots."|Each treatment: the assessment of the condition of the venous header after rinse-back|||Number of Dialyzers|Dialyzers||Number
763026|NCT00659724|Primary|Dialyzer Assessment: Arterial Header Condition|"For every study treatment/dialyzer, the nursing staff rated the condition of the arterial header after rinse-back as follows:
Very Good:Surface as clean as expected. Good:Distinct red ring appears at the dialyzer wall. Poor:Significant appearance of clots, randomly distributed on the surface. Very Poor:Completely red and/or covered with clots."|Each treatment: assessment of the condition of the arterial header after rinse-back|||Number of Dialyzers|Dialyzers||Number
763027|NCT00659724|Primary|Dialyzer Assessment: Fiber Condition|"For every study treatment/dialyzer, the nursing staff rated the condition of the dialyzer fibers after rinse-back as follows:
Very Good:All fibers appear white. Good:Few fibers (less than 10) appear PINK / RED. (check one) Poor:Several fibers (more than 10) appear PINK / RED. (check one) Very Poor:Most fibers (more than 75%) appear PINK / RED. (check one)"|Each treatment: assessment of the condition of the dialyzer fibers after rinse-back|||Number of Dialyzers|Dialyzers||Number
763028|NCT00659724|Primary|Ease of Use: Priming Dialysate Side|"For every study treatment/dialyzer, the nursing staff rated the ease of priming dialysate side as follows:
Dialysate Side at 500 ml Priming Volume (check one):
Perfect: No air visible. Acceptable: Some air visible, but considered insignificant. Not Acceptable: Additional actions needed to sufficiently remove air."|Priming at each treatment|||Number of Dialyzers|Dialyzers||Number
763029|NCT00659724|Primary|Ease of Use: Priming Blood Side|"For every study treatment/dialyzer, the nursing staff rated the ease of priming blood side as follows:
Very Easy:Air is easily removed without knocking or clamping procedures. Acceptable:Knocking and/or clamping required for efficient air removal. Difficult:Knocking and/or clamping and additional volume of saline or extended recirculation needed to remove air.
Very Difficult:Air could not be removed."|Priming at each treatment|||Number of Dialyzers|Dialyzers||Number
763030|NCT00659737|Primary|Number of Participants With Postoperative Nausea and Vomiting||0-24 hours|||participants|||Number
763031|NCT00659789|Secondary|Effects on Vacc-4x on HIV-1 RNA||Weeks 24,28,32,36,40,44,48,52.|||copies/mL||Standard Deviation|Mean
763032|NCT00659789|Secondary|Time to Restart of ART for Vacc-4x Subjects Versus Placebo|Kaplan-Meier Estimate of Time to restart ART (from time coming off ART)|Between Week 28 to Week 52|ITT Population||days||Standard Deviation|Mean
763033|NCT00659789|Secondary|Effect of Vacc-4x on CD8 Counts|CD8 Count Over Time for subjects who stopped ART at Week 28 and remained off ART until Week 52|Weeks 6,18,24,28,32,36,40,44,48,52.|Subject who stopped ART at week 28 and remained off ART until week 52||cells/µL||Inter-Quartile Range|Median
763034|NCT00659789|Secondary|Immunogenicity|Immunogenicity of Vacc-4x evaluated by DTH (Delayed-type Hypersensitivity) reaction. The number of participants showing induration and/or erythema|Week 1, week 18 and week 52|ITT Population||participants|||Number
763035|NCT00659789|Secondary|Number of Participants With Any Treatment Emergent Adverse Event, Related Treatment Emergent Adverse Events and Deaths|Brief summary of treatment emergent adverse events or related treatment emergent events and deaths. The intensity of adverse events was described according to the Division of AIDS table for grading severity of adult and pediatric adverse events, 2004.|Up to week 52|Safety Population||participants|||Number
763036|NCT00659789|Primary|Proportion of Subjects Who Require Resumption of ART Between the Interruption of ART at Week 28 and End of Study at Week 52.||From Week 28 to Week 52|ITT Population||participants|||Number
763037|NCT00659815|Primary|Lens Deposits|Lens Deposits (All Eligible, Dispensed Eyes) Absent = deposit ratings of none or light; Present = deposit ratings of medium or heavy.|Over-all study visits, baseline to 1-month|Lens deposits over all scheduled follow-up visits (all eligible, dispensed eyes with non-missing data)||Eyes|Participants||Number
763038|NCT00659815|Primary|Slit Lamp Findings|Graded 0-4 where Grade 0=none; Grade 1=Trace; Grade 2=Mild; Grade 3=Moderate; Grade 4=Severe.|Over-all follow-up visits from baseline to1 month|Graded Slit Lamp Findings over All Follow-Up Visits (Any finding, All Dispensed Eyes, 151 + 2 possible).||Eyes|Participants||Number
763039|NCT00659815|Primary|Comfort|Non-inferiority assessment of symptoms/complaints to rate solution comfort. Measurement based on 0-100 scale for each eye. Zero represented the least favorable rating and 100 represented the most favorable rating.|Over-all follow-up visits from baseline to 1 month|Symptoms/Complaints Over-All Scheduled Follow-Up Visits (All Eligible, Dispensed Eyes with non-missing scores)||Units on a Scale|Participants|Standard Deviation|Mean
763040|NCT00659880|Secondary|MRI Assessments|"MRI images were assessed for integration of the meniscal allograft transplant for integration of the anterior horn, body and posterior horn.
Images were also assessed for oedema in each of these 3 regions of the meniscus."|12 months|||participants|||Number
763041|NCT00659880|Primary|Knee Injury and Osteoarthritis Outcome Score (KOOS)|The score is an index score from 0 to 100, with 0 representing extreme problems and 100 representing no problems.|60 months|||units on a scale||Standard Deviation|Mean
763042|NCT00659945|Primary|Number of Participants Having Post-operative Emesis and Nausea.|Postoperative emesis was measured as present or not present (nominal data) and analyzed with Chi-square; Comparison of nausea severity was performed in two ways. In those patients who exhibited nausea VRS>0, a worst nausea score for each patient was defined as the highest nausea score recorded over the 48 hours. Mann-Whitney rank sum test was used to compare worst nausea scores. Multivariate Analysis of Variance (MANOVA) was used to determine if the mean VRS (Verbal Rating Scale) score over time was significant between the two groups.|48 hours post surgery|||participants|||Number
763050|NCT00660010|Other Pre-specified|Number of Pregnancies Reported by Subjects at Final Questionnaire|The final questionnaire was completed by 20 female subjects who were at least 18 years of age. The total number of pregnancies were reported.|Posttreatment data were collected from the final adult questionnaire (subjects >= 18 years of age)|A long-term follow-up questionnaire was sent to all subjects who completed at least 1 visit in the posttreatment follow-up period or who discontinued treatment because they entered puberty naturally at the appropriate age. Twenty female subjects (mean age 24.76 years, range 18.87 to 26.66 years) and 0 male subjects completed the questionnaire.||Pregnancies|||Number
763043|NCT00659984|Secondary|Quality of Life|Patients (aged 5-18) and parents (of patients aged 2-18) were asked to complete the 23-item Pediatric Quality of Life InventoryTM (PedsQLTM). PedsQLTM consists of 4 scales (physical, emotional, social, school functioning) which are then averaged into an overall summary score (scale: 0-100 with 0 representing the worst possible Quality of Life overall summary score and 100 representing the best possible Quality of Life overall summary score). The mean difference between the post treatment overall summary score and the baseline overall summary score is reported.|Day 60 +/- 10 days post Therapeutic Dose|Self reported PedsQL™ scores were obtained for 9 patients in the ITT population (n=15) at baseline (prior to the start of the Ultratrace™ Iobenguane I 131 imaging studies) and at the end of therapy (60 ±10 days post treatment).||units on a scale||Standard Deviation|Mean
763044|NCT00659984|Secondary|Tumor Response in CT/MRI Lesions Post Therapeutic Treatment|Measurable disease was defined for a conventional CT scan by the presence of at least one lesion that could be accurately measured in at least one dimension with the longest diameter at least 20 mm by Independent Review. Efficacy success was defined as a patient achieving a Complete Response (CR)=disappearance of all target and non-target CT/MRI lesions; or, Very Good Partial Response (VGPR)=greater than 90% decrease of the disease measurement for CT/MRI lesions, taking as reference the disease measurement done to confirm measurement disease at study entry. Non-target CT/MRI lesions stable to smaller in size; or, Partial Response (PR)=at least 30% decrease in the disease measurement for CT/MRI lesions, taking as reference the disease measurement done to confirm measurable disease at study entry. Non-target CT/MRI lesions stable to smaller in size.|Day 60 +/- 10 days post Therapeutic Dose|The evaluable population (which excludes non-evaluable responses) contains one patient less than the full ITT population.||percentage of evaluable population||95% Confidence Interval|Number
763045|NCT00659984|Secondary|Overall Objective Tumor Response Post Therapeutic Treatment|The International Neuroblastoma Response Criteria (INRC) were utilized as a basis for the overall response criteria, which incorporated responses in MIBG positive lesions,bone marrow disease, and CT/MRI lesions that met NANT-modified RECIST criteria. Efficacy success was defined as the proportion of pts who were successful overall [i.e., achieving a Complete Response (CR), Very Good Partial Response (VGPR), or Partial Response (PR)] determined by independent reviewers. CR = Disappearance of all target lesions, homovanillic acid/ vanillylmandelic acid (HVA/VMA) normal (NL); VGPR = > 90% decr of disease for CT/MRI target lesions, all pre-existing bone lesions with CR by MIBG; MIBG scan can be SD/CR in soft tissue lesions. CR in bone marrow, no new tumor sites, and NL HVA/VMA.; PR = At least 30% decr in disease measurement for CT/MRI target lesions. Bone marrow with CR, MIBG with either PR/CR in bone lesions, MIBG may be SD /CR in soft tissue lesions, and HVA/VMA may still be elevated.|Day 60 +/- 10 days post Therapeutic Dose|The evaluable population (which excludes non-evaluable responses) contains one patient less than the full ITT population.||proportion of evaluable population||95% Confidence Interval|Number
763046|NCT00659984|Secondary|Dosimetric Estimation of Radiation Absorbed Doses to Measurable Lesions|The dosimetric endpoint was to estimate radiation absorbed doses to measurable lesions and to a standard set of normal organs following an imaging dose of 0.1 mCi/kg Ultratrace™ Iobenguane I 131. Biodistribution was assessed by determination of total body residence (TBR) time and by visual examination of whole body camera images. 3 timepoints were used, the 1st image was taken within 1hr after the imaging dose, the 2nd image was taken at ~24hr after imaging dose, the 3rd image was taken 2-5d after imaging dose. Whole body radiation absorbed dose estimates & kidney, liver, and lung were calculated using the Medical Internal Radiation Dose (MIRD) schema.TBR time is derived from time integration of curve-fitted injected activity across all 3 timepoints when the isotope is emitting radiation.Three points are sampled to estimate a singular value for each organ and tissue according to the commonly used methods of the Society of Nuclear Medicine and Molecular Imaging Committee on MIRD.|Day 5 post Dosimetric Dose|A total of 15 patients underwent dosimetry (received a single imaging dose of Ultratrace™ Iobenguane I 131 injection).||Gy||Standard Deviation|Mean
763047|NCT00659984|Secondary|Dose Limiting Toxicities|Dose limiting toxicities include treatment emergent adverse events (TEAEs) that were possibly, probably, or definitely related to Ultratrace™ Iobenguane I 131.|From the time of signed informed consent until Day 60 or until the end of therapy evaluation is completed (whichever comes first).|A total of 15 patients underwent dosimetry (received a single imaging dose of Ultratrace™ Iobenguane I 131 injection) and all 15 patients later received a single therapeutic dose of Ultratrace™ Iobenguane I 131.||number of DLTs|||Number
763048|NCT00659984|Primary|Maximum Tolerated Dose|The maximum tolerated dose (MTD) was defined as the dose immediately below the level at which dose escalation would be stopped due to dose limiting toxicities (DLTs). Once the MTD was reached, an additional 3 patients were to be treated at that dose level, for a total of 6 patients at that planned dose level. DLTs were defined as any of the events that are possibly, probably or definitely attributable to UltratraceTM iobenguane I 131. The MTD was supposed to be the highest dose tested at which fewer than 1/3 of pts experience a DLT when 6 patients have been treated at the MTD but the dosimetry results indicated that the maximal dosage allowed to normal organs would be exceeded if the highest planned dose (21.0 mCi/kg) was administered, so the highest dose administered in the study was 18.6 mCi/kg .|Day 60 +/-10 or Engraftment, whichever comes first|A total of 15 patients underwent dosimetry (received a single imaging dose of Ultratrace™ Iobenguane I 131 injection) and all 15 patients later received a single therapeutic dose of Ultratrace™ Iobenguane I 131.||mCi/kg|||Number
763049|NCT00660010|Primary|Percentage of Subjects (n/N) With Suppression of Clinical Sexual Characteristics According to Tanner Staging (Genital Development in Males)|Suppression of clinical sexual characteristics was defined as regression (improvement) or no progression of genital development in males. Tanner staging is a scale of physical development that defines primary and secondary sex characteristics including size of genitals. The final visit occurred at a mean age +/- SD of 12.35 +/-1.35 years (range, 10.71 to 14.07 years).|Week 4, Week 48 (Year 1), yearly for 5 years (Week 240), and Final Visit|The intent-to-treat (ITT) population and safety analysis set were identical for the treatment period. The starting population comprised 6 males (genital development suppression). Study drug was discontinued at the initiation of puberty.||Percentage of subjects|||Number
763061|NCT00660023|Secondary|Number of Participants Receiving Blood Transfusion During the DTP and EEP|The number of participants who received blood transfusion during the DTP (Weeks 0 and 16) and EEP (Weeks 18 to 24) was reported.|Continuously and at every visit from Week 0 (every week until Week 2, thereafter every 2 weeks) through Week 24|ITT Population; the number (n) of participants who received at least one dose during the specific period was used for analysis.||participants|||Number
763051|NCT00660010|Other Pre-specified|Number of Subjects Who Reported Pregnancies at Final Questionnaire|The final questionnaire was completed by 20 females who were at least 18 years of age. The subjects reported on total number of pregnancies resulting in live births or number of miscarriages (spontaneous or elective) and whether the subject was currently pregnant.|Posttreatment data were collected from the final adult questionnaire (subjects >= 18 years of age)|A long-term follow-up questionnaire was sent to all subjects who completed at least 1 visit in the posttreatment follow-up period or who discontinued treatment because they entered puberty naturally at the appropriate age. Twenty female subjects (mean age 24.76 years, range 18.87 to 26.66 years) and 0 male subjects completed the questionnaire.||Subjects|||Number
763052|NCT00660010|Other Pre-specified|Number of Female Subjects Who Reported Regular Menses at Adulthood|Subjects were required to complete final adult questionnaire to provide information on adult reproductive function. Regular menses was defined as 3 or more consecutive days of menstrual-like bleeding.|Posttreatment data were collected from the final adult questionnaire (subjects >= 18 years of age)|A long-term follow-up questionnaire was sent to all subjects who completed at least 1 visit in the posttreatment follow-up period or who discontinued treatment because they entered puberty naturally at the appropriate age. Twenty female subjects (mean age 24.76 years, range 18.87 to 26.66 years) and 0 male subjects completed the questionnaire.||Subjects|||Number
763053|NCT00660010|Other Pre-specified|Mean Time to or Mean Age at Regular Menses in Females After Treatment|Regular menses was defined as 3 or more consecutive days of menstrual-like bleeding and was defined by the investigator's clinical judgment.|Posttreatment during the follow-up period (subjects observed every 6 months until physical and laboratory observations are at pubertal levels)|During the posttreatment period, data were obtained from 32 female subjects. Twenty-seven subjects reported the start of menses, but only 26 subjects reported a menses start date.||years||Standard Deviation|Mean
763054|NCT00660010|Other Pre-specified|Posttreatment Height (ht.) Compared to Standard Population and as Predicted From Ht. at Baseline (BL)|Height was measured by stadiometer and was standardized for age according to standard growth charts. A standardized score of 0 indicated a mean ht. equivalent to mean of a standard population from 2000 CDC standardized ht. charts. Height gain was calculated as ht. - predicted ht. from the Bayley-Pinneau method on the basis of bone age at baseline. Final adult ht. was determined by measurement at final adult ht., if available, or by ht. collected during the follow-up period associated with a growth velocity <1 cm/year or a bone age >14 yrs in females or >15 yrs in males.|Final ht. (measured or provided for final questionnaire in subjects >= 18 years of age) or near final adult ht. (<1 cm/year or bone age > 14 years for females or > 15 years for males)|For the follow-up posttreatment period, the ITT population=40 subjects and the safety population=55 subjects who received at least 1 injection of study drug during the treatment period. Study drug was discontinued at the initiation of puberty. The mean age of subjects at final questionnaire completion was 24.76 years with a range of 18.87 to 26.66.||cm||Standard Error|Mean
763055|NCT00660010|Secondary|Mean Ratio of Bone Age to Chronological Age|Bone age was determined by radiography of the wrist according to the Fels Method. The mean ratio of bone age to chronological age provides information about the slowing of bone age progression. A score = 1 indicates that bone age is equal to chronological age.|Week 24 and Week 48 (Year 1), yearly for 5 years (Week 240), and Final Visit|The intent-to-treat (ITT) population and safety analysis set were identical for the treatment period. Study drug was discontinued at the initiation of puberty.||ratio||Standard Deviation|Mean
763056|NCT00660010|Secondary|Mean Stimulated Testosterone Concentrations in Males|Mean stimulated testosterone concentrations were assessed according to the DELFIA (registered trademark) assay. The final visit for measurement of testosterone occurred at a mean age +/- SD of 12.34 +/- 1.16 (range, 11.14 to 14.07) years.|Baseline, Weeks 4, 12, 24, 48 (Year 1), yearly for 5 years (Week 240), and Final Visit|All males in the intent-to-treat (ITT) population and safety analysis set were identical for the treatment period. Study drug was discontinued at the initiation of puberty.||ng/dL||Standard Deviation|Mean
763057|NCT00660010|Secondary|Mean Stimulated Estradiol Concentrations in Females|Mean estradiol concentrations were assessed according to the DELFIA (registered trademark) assay. The lower limit of quantitation for estradiol is 5 pg/mL and measurements below this limit are given a value of 5 pg/mL. The final visit for measurement estradiol concentrations occurred at a mean age +/- SD of 10.93 +/- 1.27 (range, 5.59 to 13.24) years.|Baseline, Weeks 4, 12, 24, 48 (Year 1), yearly for 5 years (Week 240), and Final Visit|All females in the intent-to-treat (ITT) population and safety analysis set were identical for the treatment period. Study drug was discontinued at the initiation of puberty.||pg/mL||Standard Error|Mean
763058|NCT00660010|Secondary|Mean Peak Stimulated Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Concentrations|Mean peak stimulated visit LH and FSH concentrations were assessed according to the DELFIA (registered trademark) assay. The final visit for measurement of both hormone concentrations occurred at a mean age +/- SD of 11.13 +/- 1.23 (range, 6.73 to 14.07) years.|Baseline, Weeks 4, 12, 24, 48 (Year 1), yearly for 5 years (Week 240), and Final Visit|The intent-to-treat (ITT) population and safety analysis set were identical for the treatment period. The starting population comprised 49 females and 6 males. Study drug was discontinued at the initiation of puberty.||mIU/mL||Standard Deviation|Mean
763059|NCT00660010|Primary|Percentage of Subjects (n/N) With Suppression of Clinical Sexual Characteristics According to Tanner Staging (Breast Development in Females)|Suppression of clinical sexual characteristics was defined as regression (improvement) or no progression of breast development in females. Tanner staging is a scale of physical development that defines primary and secondary sex characteristics including size of breasts. The final visit occurred at a mean age +/- SD of 11.05 +/- 1.14 years (range, 6.96 to 12.95 years).|Week 4, Week 48 (Year 1), yearly for 5 years (Week 240), and Final Visit|The intent-to-treat (ITT) population and safety analysis set were identical for the treatment period. The starting population comprised 49 females (breast development suppression). Study drug was discontinued at the initiation of puberty.||Percentage of subjects|||Number
763060|NCT00660023|Secondary|Number of Blood Transfusions During the DTP and EEP|The number of blood transfusion during the DTP (Weeks 0 and 16) and EEP (Weeks 18 to 24) was reported.|Continuously and at every visit from Week 0 (every week until Week 2, thereafter every 2 weeks) through Week 24|ITT Population; the number (n) of participants who received at least one dose during the specific period was used for analysis.||blood transfusions|||Number
765037|NCT00674154|Primary|Decrease in Preoperative P-PTH|Decrease in plasma PTH after 25 weeks of preoperative vitamin D treatment compared with the plasebo Group.|25 weeks|||pmol/l||Standard Error|Mean
763062|NCT00660023|Secondary|Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA During the DTP and EEP|Study drug administration occurred monthly during the DTP (Weeks 0 to 16), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during Week -1. Subsequent doses could be adjusted throughout the study including during the EEP (Weeks 18 to 24) on the basis of Hb levels or other modification criteria. The percentage of participants who required a dose adjustment for any reason was calculated during the DTP and EEP.|Weeks 0, 4, 8, 12, 16, 20, and 24|ITT Population; the number (n) of participants who received at least one dose during the specific period was used for analysis.||percentage of participants|||Number
763063|NCT00660023|Secondary|Mean Dose of Mircera/CERA During the Dose Titration Period (DTP) and EEP|Study drug administration occurred monthly during the DTP (Weeks 0 to 16), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during Week -1. Subsequent doses could be adjusted throughout the study including during the EEP (Weeks 18 to 24) on the basis of Hb levels or other modification criteria. The dose received at each administration visit was averaged among all participants during the DTP and EEP and expressed in mcg.|Weeks 0, 4, 8, 12, 16, 20, and 24|ITT Population; the number (n) of participants who received at least one dose during the specific period was used for analysis.||mcg||Standard Deviation|Mean
763064|NCT00660023|Secondary|Mean Time Spent in the Target Range for Hb During the EEP|During the EEP (Weeks 18 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with CERA/Mircera. Time spent in the target range of 10.0 to 12.0 g/dL was defined as time from first on-target Hb to time of last known on-target Hb, as collected during the EEP. Time spent in the target range was averaged among all participants and expressed in days.|Pre-dose (0 hours) during Weeks 18, 20, 22, and 24|ITT Population.||days||Standard Deviation|Mean
763065|NCT00660023|Secondary|Percentage of Participants Whose Hb Remained Within Target Range Throughout the EEP|During the EEP (Weeks 18 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with CERA/Mircera. The percentage of participants who maintained each single Hb measurement in the target range of 10.0 to 12.0 g/dL was determined. The 95% CI was calculated using the Pearson-Clopper method for exact confidence bounds.|Pre-dose (0 hours) during Weeks 18, 20, 22, and 24|ITT Population.||percentage of participants||95% Confidence Interval|Number
763066|NCT00660023|Secondary|Mean Change in Time-Adjusted Hb From Baseline to EEP|"Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment stability assessment (Weeks -4 to -1). During the EEP (Weeks 18 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with CERA/Mircera. The average Hb during the EEP was calculated per participant and assessed against the reference value. The mean change in Hb value between reference (i.e., Baseline) Hb and the EEP average Hb was calculated and expressed in g/dL."|At Weeks -4, -3, -2, and -1; pre-dose (0 hours) during Weeks 18, 20, 22, and 24|ITT Population.||g/dL||Standard Deviation|Mean
763067|NCT00660023|Primary|Percentage of Participants Who Maintained Average Hb Within Plus/Minus (±) 1 g/dL of Reference Hb and Within Target Range During the Efficacy Evaluation Period (EEP)|Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment stability assessment (Weeks -4 to -1). During the EEP (Weeks 18 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with CERA/Mircera. The average Hb during the EEP was calculated per participant and assessed against the reference value. The percentage of participants who had average Hb during the EEP in the target range of 10.0 to 12.0 g/dL and within ±1 g/dL of their individual reference Hb was determined as the primary endpoint. The 95 percent (%) confidence interval (CI) was calculated using the Pearson-Clopper method for exact confidence bounds.|Weeks -4, -3, -2, and -1; pre-dose (0 hours) during Weeks 18, 20, 22, and 24|Per Protocol (PP) Population: All participants from the ITT Population who fulfill inclusion/exclusion criteria per study protocol.||percentage of participants||95% Confidence Interval|Number
763068|NCT00660049|Secondary|Adverse Events|severity and frequency of adverse events|1 month||12/2016||||
763069|NCT00660049|Primary|Ease of Use for Patients|Participants were given instructions to use the SNaP device home. Participants completed a questionnaire reporting whether the device was easy to use, worthwhile to use, and whether they would use the device again. Numbers responding positively to each question are presented.|Baseline up to 31 days|All participants||participants|||Number
763070|NCT00666835|Secondary|Mean Absolute Change in Hemoglobin Level From the Screening/Baseline Period to the Evaluation Period - ITT Population|The mean absolute change in Hb levels between the screening/baseline period and the evaluation period was analyzed for the intent-to-treat (ITT) population in the same way as the primary efficacy endpoint. A two-sided 95 % confidence interval for the difference in mean change (mean of evaluation period - mean of screening/baseline period) in Hb between HX575 epoetin alfa Hexal AG and ERYPO® Janssen-Cilag was computed. The difference was estimated from an analysis of a co-variance model including factors treatment, center, mean baseline Hb (<11.5 and ≥11.5 g/dL) as factors and change of the mean weekly dose from screening/baseline to the evaluation period (of HX575 epoetin alfa Hexal AG or ERYPO® Janssen-Cilag) as a covariate. HX575 Hexal AG was considered at least as good as ERYPO® Janssen-Cilag if the 95 % confidence interval of the difference in mean changes in Hb levels between HX575 Hexal AG and ERYPO® Janssen-Cilag lied entirely within the interval [-0.5 g/dL; 0.5 g/dL].|28 weeks|Intent-to-treat population (ITT): all randomized patients who received at least one dose of the study medication and for whom at least one post-baseline value of the primary endpoint Hb was available. A prerequisite to be included in the ITT population was that they were treated for four weeks with Hb values available during this period.||g/dL||Standard Error|Least Squares Mean
763081|NCT00666926|Secondary|Time to Reach Maximum Observed Serum Concentration (Tmax): MDZ||C0.D1, C1.D21 Expansion cohort E1 US sites only: 0 hr (prior to MDZ dosing) and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hrs post MDZ dose|N=participants in the PK parameter analysis set who received MDZ dosing prior to PF-00562271 in the 125 mg BID cohort; (n)=number of participants with analyzable data at observation.||hours||Full Range|Median
763082|NCT00666926|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf): MDZ|AUCinf = area under the serum concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|C0.D1, C1.D21 Expansion cohort E1 US sites only: 0 hr (prior to MDZ dosing) and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hrs post MDZ dose|N=participants in the PK parameter analysis set who received MDZ dosing prior to PF-00562271 in the 125 mg BID cohort; (n)=number of participants with analyzable data at observation.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
763071|NCT00666835|Primary|To Compare the Efficacy of HX575 Hexal AG and ERYPO® Janssen-Cilag.|Primary endpoint was the mean absolute change in Hb level between the screening/baseline and the evaluation period. A two-sided 95 % confidence interval for the difference in mean change (mean of evaluation period – mean of screening/baseline period) in Hb between epoetin alfa HX575 Hexal AG and ERYPO® Janssen-Cilag was computed. The difference was estimated from an analysis of a co-variance model including factors treatment, center, mean baseline Hb (<11.5 and ≥11.5 g/dL) as factors and change of the mean weekly dose from screening/baseline to the evaluation period (of HX575 epoetin alfa Hexal AG or ERYPO® Janssen-Cilag) as a covariate. HX575 Hexal AG was considered at least as good as ERYPO® Janssen-Cilag if the 95 % confidence interval of the difference in mean changes in Hb levels between HX575 Hexal AG and ERYPO® Janssen-Cilag lied entirely within the interval [–0.5 g/dL; 0.5 g/dL]. Primary Endpoint was analyzed based on intent-to-treat (ITT) population.|28 weeks|Primary Endpoint was analyzed based on ITT population: all treated patients with a post baseline hemoglobin value.||g/dL||Standard Error|Least Squares Mean
763072|NCT00666848|Primary|Change in MAP During Sitagliptin|Mean change in mean arterial pressure in response to placebo or enalapril in the presence of 5 days of sitagliptin 100mg/day|just prior to drug administration and 8 hours following treatment|||mmHg||Standard Deviation|Mean
763073|NCT00666848|Primary|Change in MAP During Placebo|The change in mean arterial pressure (MAP) in response to placebo or enalapril after pretreatment with 5 days of placebo|just prior to drug administration and 8 hours after drug administration|||mmHg||Standard Deviation|Mean
763074|NCT00666926|Secondary|Caspase-3|Analysis of tumor specimens to assess FAK-related biomarkers for potential predictors of response markers to PF-00562271; sequential activation of caspases plays a central role in the execution-phase of cell apoptosis. For dose escalation cohorts and expansion cohort E1, pre-treatment tumor biopsy collected between Day -28 and first PF-00562271 dose and on-treatment tumor biopsy collected 2 to 8 hours after PF-00562271 dose during Cycle 1 between day 12 and 16. In addition, up to 10 participants in cohort E2 were to be enrolled for serial biopsies.|Baseline (up to 28 days prior to first dose) up to 12 cycles (cycle=21days)|Data was not summarized as samples were processed and analyzed later than 3 days after collection and thus the data were considered unusable.|||||
763075|NCT00666926|Secondary|Phospho-SRC (pSRC)|Analysis of tumor specimens to assess FAK-related biomarkers for potential predictors of response markers to PF-00562271; SRC proto-oncogenes are regulators of growth and differentiation of eukaryotic cells and are implicated in development of human tumors. For dose escalation cohorts and expansion cohort E1, pre-treatment tumor biopsy collected between Day -28 and first PF-00562271 dose; on-treatment tumor biopsy collected 2 to 8 hours after PF-00562271 dose during Cycle 1 between day 12 and 16. In addition, up to 10 participants in cohort E2 were to be enrolled for serial biopsies.|Baseline (up to 28 days prior to first dose) up to 12 cycles (cycle=21days)|Data was not summarized as samples were processed and analyzed later than 3 days after collection and thus the data were considered unusable.|||||
763076|NCT00666926|Secondary|Phosphorylated Mitogen Activated Pathway Kinase (pMAPK)|Analysis of tumor specimens to assess FAK-related biomarkers for potential predictors of response markers to PF-00562271; MAPK regulates activities of several transcription factors. A defect in MAPK pathway leads to uncontrolled cell growth. For dose escalation cohorts and expansion cohort E1, pre-treatment tumor biopsy collected between Day -28 and first PF-00562271 dose and on-treatment tumor biopsy collected 2 to 8 hours after PF-00562271 dose during Cycle 1 between day 12 and 16. In addition, up to 10 participants in cohort E2 were to be enrolled for serial biopsies.|Baseline (up to 28 days prior to first dose) up to 12 cycles (cycle=21days)|Data was not summarized as samples were processed and analyzed later than 3 days after collection and thus the data were considered unusable.|||||
763077|NCT00666926|Secondary|Phosphorylated Focal Adhesion Kinase (pFAK)|Analysis of tumor specimens to assess FAK-related biomarkers for potential predictors of response markers to PF-00562271; FAK is overexpressed in a variety of human cancers. For dose escalation cohorts and expansion cohort E1, pre-treatment tumor biopsy collected between Day -28 and first PF-00562271 dose and on-treatment tumor biopsy collected 2 to 8 hours after PF-00562271 dose during Cycle 1 between day 12 and 16. In addition, up to 10 participants in cohort E2 were to be enrolled for serial biopsies.|Baseline (up to 28 days prior to first dose) up to 12 cycles (cycle=21days)|Data was not summarized as samples were processed and analyzed later than 3 days after collection and thus the data were considered unusable.|||||
763078|NCT00666926|Secondary|Percentage of Participants With Best Overall Response as Measured Using the Response Evaluation Criteria in Solid Tumors (RECIST)|Best response recorded from start of treatment (Tx) until disease progression. Complete response: disappearance of all target lesions. Partial response: ≥30% decrease in sum of longest dimensions (LD) of target lesions referencing baseline sum LD. Progressive disease: ≥20% increase in sum LD of target lesions from smallest sum LD recorded since Tx start or appearance of ≥1 new lesions. Stable disease: neither sufficient shrinkage to=PR nor sufficient increase to=PD during first 6 weeks after Tx start referencing smallest sum LD since Tx start.|Baseline up to 12 cycles (cycle=21days)|RECIST response analysis set: all enrolled participants who had an adequate baseline tumor assessment, measureable disease and who started treatment. N=number of participants with evaluable data at observation.||percentage of participants|||Number
763079|NCT00666926|Secondary|Apparent Oral Clearance (CL/F): MDZ|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.|C0.D1, C1.D21 Expansion cohort E1 US sites only: 0 hr (prior to MDZ dosing) and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hrs post MDZ dose|N=participants in the PK parameter analysis set who received MDZ dosing prior to PF-00562271 in the 125 mg BID cohort; (n)=number of participants with analyzable data at observation.||mL/hr||Geometric Coefficient of Variation|Geometric Mean
763080|NCT00666926|Secondary|Serum Decay Half-life (t 1/2): MDZ|Serum decay half-life is the time measured for the serum concentration to decrease by one half.|C0.D1, C1.D21 Expansion cohort E1 US sites only: 0 hr (prior to MDZ dosing) and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hrs post MDZ dose|N=participants in the PK parameter analysis set who received MDZ dosing prior to PF-00562271 in the 125 mg BID cohort; (n)=number of participants with analyzable data at observation.||hours||Standard Deviation|Mean
763128|NCT00667251|Secondary|Overall Survival|OS median follow-up not achieved; estimated with quartile estimates|From randomization to death from any cause, assessed up to 44 months.|two subpopulations: ITT (n=652) and HER2+ (n=537)||Months||Inter-Quartile Range|Median
763083|NCT00666926|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast): MDZ|Area under the serum concentration time-curve from zero to the last measured concentration.|C0.D1, C1.D21 Expansion cohort E1 US sites only: 0 hr (prior to MDZ dosing) and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hrs post MDZ dose|N=participants in the PK parameter analysis set who received MDZ dosing prior to PF-00562271 in the 125 mg BID cohort; (n)=number of participants with analyzable data at observation.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
763084|NCT00666926|Secondary|Maximum Serum Concentration (Cmax): MDZ||C0.D1, C1.D21 Expansion cohort E1 US sites only: 0 hr (prior to MDZ dosing) and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hrs post MDZ dose|N=participants in the PK parameter analysis set who received MDZ dosing prior to PF-00562271 in the 125 mg BID cohort; (n)=number of participants with analyzable data at observation.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
763085|NCT00666926|Secondary|Observed Accumulation Ratio (Rac): PF-00562271 C1.D14|Rac was the ratio of the Day 14 AUC0-tau (0 hour to last dose interval) and AUC during the corresponding time period after the lead-in dose (AUCtau C1.D14/AUCtau C0.D1).|Escalation (Esc) cohort: C0.D1: 0 hr, and 0.5, 1, 2, 4, 6, 7,12 hrs post dose; Expansion (Exp) cohort: C0:D1: 0 hr, and 1, 2, 4, 8 hrs post dose; Esc and Exp cohorts: C1.D14 0 hour, and 0.5, 1, 2, 4, 6, 8, 12 (if BID) or 24 (if QD) hrs post am dose|PK parameter analysis set||ratio||Geometric Coefficient of Variation|Geometric Mean
763086|NCT00666926|Secondary|Area Under the Curve From Time Zero to the End of the Dosing Interval (AUCtau): PF-00562271 C1.D14||Escalation and Expansion E1 and E2 cohorts: C1.D14 0 hour (0 hr=pre-dose PF-00562271), and 0.5, 1, 2, 4, 6, 8, 12 (if BID) or 24 (if QD) hrs post am dose|PK parameter analysis set||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
763087|NCT00666926|Secondary|Minimum Observed Serum Trough Concentration (Cmin): PF-00562271 C1.D14||Escalation and Expansion E1 and E2 cohorts: C1.D14 0 hour (0 hr=pre-dose PF-00562271), and 0.5, 1, 2, 4, 6, 8, 12 (if BID) or 24 (if QD) hrs post am dose|PK parameter analysis set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
763088|NCT00666926|Secondary|Apparent Oral Clearance (CL/F): PF-00562271 C0. D1, C1.D1|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.|Escalation cohorts: C0.D1 0 hour (0 hr=pre-dose PF-00562271), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post dose; Expansion E1 US cohort: C1.D1 0 hr (prior to MDZ dose); E1 non-US and E2 cohort: C1.D1 0 hr and 0.5, 1, 2, 4 hrs post C1.D1 am dose|PK parameter analysis set. Escalation cohorts: Cycle 0 48 hours post dose timepoint = C1.D1.||milliliters per minute (mL/min)||Geometric Coefficient of Variation|Geometric Mean
763089|NCT00666926|Secondary|Serum Decay Half-life (t 1/2): PF-00562271 C0.D1, C1.D1|Serum decay half-life is the time measured for the serum concentration to decrease by one half.|Escalation cohorts: C0.D1 0 hour (0 hr=pre-dose PF-00562271), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post dose; Expansion E1 US cohort: C1.D1 0 hr (prior to MDZ dose); E1 non-US and E2 cohort: C1.D1 0 hr and 0.5, 1, 2, 4 hrs post C1.D1 am dose|PK parameter analysis set. Escalation cohorts: Cycle 0 48 hours post dose timepoint = C1.D1.||hours||Standard Deviation|Mean
763090|NCT00666926|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf): PF-00562271 C0.D1, C1.D1|AUCinf = area under the serum concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Escalation cohorts: C0.D1 0 hour (0 hr=pre-dose PF-00562271), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post dose; Expansion E1 US cohort: C1.D1 0 hr (prior to MDZ dose); E1 non-US and E2 cohort: C1.D1 0 hr and 0.5, 1, 2, 4 hrs post C1.D1 am dose|PK parameter analysis set. Escalation cohorts: Cycle 0 48 hours post dose timepoint = C1.D1.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
763091|NCT00666926|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast): PF-00562271 C0.D1, C1.D1|Area under the serum concentration time-curve from zero to the last measured concentration; nanograms multiplied by hours per milliliters (ng*hr/mL).|Escalation cohorts: C0.D1 0 hour (0 hr=pre-dose PF-00562271), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post dose; Expansion E1 US cohort: C1.D1 0 hr (prior to MDZ dose); E1 non-US and E2 cohort: C1.D1 0 hr and 0.5, 1, 2, 4 hrs post C1.D1 am dose|PK parameter analysis set. Escalation cohorts: Cycle 0 48 hours post dose timepoint = C1.D1.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
763092|NCT00666926|Secondary|Time to Reach Maximum Observed Serum Concentration (Tmax): PF-00562271 C1.D14||Escalation and Expansion E1 and E2 cohorts: C1.D14 0 hour (0 hr=pre-dose PF-00562271), and 0.5, 1, 2, 4, 6, 8, 12 (if BID) or 24 (if QD) hrs post am dose|PK parameter analysis set||hours||Full Range|Median
763093|NCT00666926|Secondary|Time to Reach Maximum Observed Serum Concentration (Tmax): PF-00562271 C0.D1, C1.D1||Escalation cohorts: C0.D1 0 hour (0 hr=pre-dose PF-00562271), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post dose; Expansion E1 US cohort: C1.D1 0 hr (prior to MDZ dose); E1 non-US and E2 cohort: C1.D1 0 hr and 0.5, 1, 2, 4 hrs post C1.D1 am dose|PK parameter analysis set. Escalation cohorts: Cycle 0 48 hours post dose timepoint = C1.D1.||hours||Full Range|Median
763094|NCT00666926|Secondary|Maximum Serum Concentration (Cmax): PF-00562271 C1.D14||Escalation and Expansion E1 and E2 cohorts: C1.D14 0 hour (0 hr=pre-dose PF-00562271), and 0.5, 1, 2, 4, 6, 8, 12 (if BID) or 24 (if QD) hrs post am dose|PK parameter analysis set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
763095|NCT00666926|Secondary|Maximum Serum Concentration (Cmax): PF-00562271 C0.D1, C1.D1||Escalation cohorts: C0.D1 0 hour (0 hr=pre-dose PF-00562271), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post dose; Expansion E1 US cohort: C1.D1 0 hr (prior to MDZ dose); E1 non-US and E2 cohort: C1.D1 0 hr and 0.5, 1, 2, 4 hrs post C1.D1 morning (am) dose|Pharmacokinetic (PK) parameter analysis set: all participants with at least 1 dose of study treatment and at least 1 of the PK parameters of interest estimated in at least 1 treatment period. Escalation cohorts: Cycle 0 48 hours post dose timepoint = C1.D1.||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
763096|NCT00666926|Primary|Percentage of Participants With Tumor Metabolic Response (Reduction of ≥15%) in Positron Emission Tomography With F-18-fluorodeoxyglucose (FDG-PET)|Metabolic response demonstrated in any tumor reduction of ≥15% in tumor FDG standardized uptake value (SUV) in Cycle 1; based on the recommendations of the European Organization for Research and Treatment of Cancer (EORTC) PET Study Group. Participant must have had a baseline PET with at least 1 tumor lesion demonstrating an FDG SUV of ≥5.|Baseline, C1.D14|Participants in the 125 mg BID expansion cohort with at least 1 dose of study treatment, at least 1 lesion with an SUV ≥5 at baseline, and an on-study PET assessment C1.D14 (Day 13 up to Day 17).||percentage of participants||90% Confidence Interval|Number
763097|NCT00666926|Primary|Number of Participants With First Cycle Dose Limiting Toxicities (DLTs)|At least possibly attributable to study treatment (Tx): Grade (Gr) 4 neutropenia (absolute neutrophil count [ANC] <500 cells/mm^3) for >7 days or Gr 3 febrile neutropenia (ANC <1000/mm^3, fever ≥38 degrees Celsius; Gr 4 thrombocytopenia (platelets <25,000 cells/mm^3); Gr ≥3 non-hematologic toxicity despite adequate medical intervention; Gr ≥3 confirmed prolonged QTc interval (>500 milliseconds [msec]); confirmed cardiac troponin I ≥99 percentile of reference range; Tx related toxicities with failure to receive ≥18 days Tx in 21-day cycle or inability to resume current dose level ≤14 days.|Baseline up to Cycle 1 Day 21 (C1.D21)|Safety analysis set: All enrolled participants who started treatment.||participants|||Number
763098|NCT00666965|Secondary|IRLS Each Parameter|"IRLS is a scale for assessing severity of restless legs syndrome symptoms. IRLS consists of ten questions. Each question is scored from 4 for the first (top) answer (usually ‘very severe’) to 0 for the last answer (usually none).
The sum of the score of each question serves as the scale score. The scale scoring criteria are: Mild (score 1-10); Moderate (score 11-20); Severe (score 21-30); Very severe (score 31-40). A decrease in the scores means improvement.
The percentage of subjects with -3 or -4 changes from baseline in each parameter at 6 weeks after dosing is shown."|Baseline, every two weeks|FAS, LOCF||Percentage of Participants|||Number
763099|NCT00666965|Secondary|Medical Outcome Study (MOS) Short-Form 36-Item Health Survey (SF-36)|Mean Change from baseline in MOS Short Form SF-36 to 6 weeks after dosing. SF-36 is a scale for assessing health status in clinical practice and research. The scores of 36 questions are summarized into 7 sub-scales. In each sub-scale which range is 0-100, a higher score indicates a better health status. Thus a increase in the scores means improvement.|Baseline, every two weeks|FAS, LOCF||Scores on a scale||Standard Deviation|Mean
763100|NCT00666965|Secondary|The Pittsburgh Sleep Quality Index (PSQI)|"PSQI is a scale for assessing severity of sleep disorders. The score ranges from 0 to 21. 0 indicates “no difficulty” and 21 indicates “severe difficulty”. A decrease in the scores means improvement.
The data at 6 weeks after dosing is shown."|Baseline, every two weeks|FAS, LOCF||Percentage of Participants|||Number
763101|NCT00666965|Secondary|Patient Global Impression (PGI) Improvement|The PGI-I is a self-rated 7-point scale, with scores ranging from 1 (very much improved) to 7 (very much worse), that assesses the improvement or worsening of a patient's illness relative to baseline at the beginning of the intervention. Scores: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; or 7=very much worse. Moderate and marked improvement = score of 1 or 2, Without improvement = score of 4, Marked and moderate aggravation = score of 6 or 7.|Baseline, 4 weeks and 6 weeks. The data at 6 weeks after dosing is shown.|FAS, LOCF||Percentage of Participants|||Number
763102|NCT00666965|Secondary|Clinical Global Impression (CGI) Severity|"CGI is a clinician-reported scale for assessing severity of illness.
The sale scoring criteria are 1: Normal, not at all ill, 2: Borderline ill, 3: Mildly ill, 4: Moderately ill, 5: Markedly ill, 6: Severely ill, 7: Among the most extremely ill patients."|Baseline, 2 weeks, 4 weeks and 6 weeks. The data at 6 weeks after dosing is shown.|FAS, LOCF||Percentage of Participants|||Number
763103|NCT00666965|Primary|Change of International Restless Legs Syndrome Study Group Rating Scale (IRLS) Score From the Baseline to the End of Titration/Maintenance Period|"IRLS is a scale for assessing severity of restless legs syndrome symptoms. IRLS consists of ten questions. Each question is scored from 4 for the first (top) answer (usually ‘very severe’) to 0 for the last answer (usually none).
The sum of the score of each question serves as the scale score.
The scale scoring criteria are: Mild (score 1-10); Moderate (score 11-20); Severe (score 21-30); Very severe (score 31-40). A decrease in the scores means improvement."|Baseline, end of maintenance period at 6 weeks|Full analysis set (FAS), last observation carried forward (LOCF)||scores on a scale||Standard Deviation|Mean
763104|NCT00666978|Secondary|Characterization of CYP2A6 Genotype|"Analyzed CYP2A6 by genotype. The variants present in people in the slow genotype group include *17, *20, *23,*27, *35, *9, *2, *25, *26, and *4. The fast metabolizers have none of the variant alleles tested.
Slow metabolizers have any reduction or loss of function variant. Fast metabolizers are *1/*1 genotype by exclusion."|Week 0|This variant is related to nicotine metabolism and was collected from all study participants but not analyzed by study arm as it does not relate to the study medication. Data pre-specified to be collected and reported as a single arm.||Participants|||Count of Participants
763105|NCT00666978|Secondary|Characterization of CYP2B6 Activity.|We genotyped CYP2B6 in 268 from the Bupropion arm as this polymorphism is related to bupropion metabolism.|Week 3|||Participants|||Count of Participants
763106|NCT00666978|Secondary|Characterization of CYP2A6 Activity.|"Analyzed CYP2A6 by activity, called the nicotine metabolite ratio using a split between slow and fast metabolism at 0.31.
The variants present in people in the slow genotype group include *17, *20, *23,*27, *35, *9, *2, *25, *26, and *4. The fast metabolizers have none of the variant alleles tested.
Blood samples were collected for 3HC/COT ratio at Week 0. Cessation outcomes were assessed at Weeks 7 and 26."|Weeks 0|This variant is related to nicotine metabolism and was collected from all study participants but not analyzed by study arm as it does not relate to the study medication. Data pre-specified to be collected and reported as a single arm.||Participants|||Count of Participants
763107|NCT00666978|Primary|Number of Participants With Salivary Cotinine-verified Smoking Abstinence at 6 Months|Salivary cotinine-verified smoking abstinence at 6 months. A cut point of 15 ng/ml was used to differentiate smokers from nonsmokers.|6 months|||Participants|||Count of Participants
763108|NCT00667095|Secondary|Number of Participants With a Decrease in Urinary Urgency at 1 Month and 3 Months|Urinary urgency was measured by the Indevus Urgency Severity Scale (IUSS). The IUSS asks patients to assess the severity of ‘urgency’ at each void. The scale employs the following wording: “Degree of urgency is meant to describe your urge to urinate. Sometimes you may feel a very strong urge to urinate and at other times, you may feel a milder urge prior to the onset of a toilet void. Rate this feeling by circling 0, 1, 2, or 3, defined as: 0: NONE – no urgency, 1: MILD – awareness of urgency, but it is easily tolerated and you can continue with your usual activity or tasks, 2: MODERATE – enough urgency discomfort that it interferes with or shortens your usual activity or tasks, 3: SEVERE – extreme urgency discomfort that abruptly stops all activity or tasks.”|Baseline, 1 month, 3 months|Analysis was done according to the principle of intention-to-treat. The sample size was reduced to 9 in the DSMO instillation arm at 3 months due to withdrawal for reasons unrelated to study (cancer).||participants|||Number
763109|NCT00667095|Secondary|Number of Participants With Decrease in Blaivas-Groutz Anti-Incontinence Score at 1 Month and 3 Months|The Blaivas-Groutz Anti-incontinence scale was used as a measure of urinary incontinence. This scale combines information on the number of incontinent episodes in a 24-hour period, 24-hour pad weights, and a qualitative rating by the patient into a single score ranging from 0 to 6. this score is then used to categorize incontinence as none (0), mild (1-2), moderate (3-4), or severe (5-6).|baseline, 1 month, 3 months|Analysis was done according to the principle of intention-to-treat. The sample size was reduced to 9 in the DSMO instillation arm at 3 months due to withdrawal for reasons unrelated to study (cancer).||participants|||Number
763110|NCT00667095|Secondary|Change in Urogenital Distress Inventory (UDI-6)|"The UDI-6 measures the effect of urinary incontinence on quality of life. It consists of 6 items, each with the response scale from 0=Not at all to 3=Greatly. The scores can range from 0 to 18; a low score indicates less impact of incontinence on quality of life."|baseline, 1 month, 3 months|Analysis was done according to the principle of intention-to-treat. The sample size was reduced to 9 in the DSMO instillation arm at 3 months due to withdrawal for reasons unrelated to study (cancer).||units on a scale||Standard Deviation|Mean
763111|NCT00667095|Secondary|Change in International Consultation on Incontinence Questionnaire – Short Form Score (ICIQ-SF)|The ICIQ-SF provides a brief and robust measure to assess the impact of symptoms of incontinence on quality of life and outcome of treatment. The questionnaire has 4 items and the score can range from 0 to 21, with greater values indicating increased severity of symptoms and lower quality of life.|baseline, 1 month, 3 months|Analysis was done according to the principle of intention-to-treat. The sample size was reduced to 9 in the DSMO instillation arm at 3 months due to withdrawal for reasons unrelated to study (cancer).||units on a scale||Standard Deviation|Mean
763112|NCT00667095|Secondary|Change in Incontinence Impact Questionnaire Short Form (IIQ-7)|"The IIQ-7 measures the effect of urinary incontinence on quality of life. It is comprised of 7 items, each with the response scale from 0=Not at all to 3=Greatly. The scores can range from 0 to 21; a low score indicates less impact of incontinence on quality of life."|baseline, 1 month, 3 months|Analysis was done according to the principle of intention-to-treat. The sample size was reduced to 9 in the Dimethyl Sulfoxide (DSMO) instillation arm at 3 months due to withdrawal for reasons unrelated to study (cancer).||units on a scale||Standard Deviation|Mean
763113|NCT00667095|Primary|Change in Incontinence Quality of Life (I-QoL) Score|"The I-QoL measures the effect of urinary incontinence on quality of life. It is divided into 3 subscales: 1) avoidance and limiting behavior, 2) psychosocial impact, and 3) social embarrassment. The I-QOL is comprised of 22 items, each with the response scale from ‘1= Extremely’ to ‘5= Not at all’.
A mean score for each subscale is calculated (averaging the scores for the items in each subscale) as well as a total score for all 22 items (sum of all subscale scores). The scores are then transformed to a ‘Scale score’ ranging from 0-100 points for ease of interpretation: Scale score = (sum of the items – lowest possible score)/possible raw score range X 100. Higher scores indicate less impact of incontinence on quality of life."|Baseline, 1 month, 3 months|Analysis was done according to the principle of intention-to-treat. The sample size was reduced to 9 in the Dimethyl Sulfoxide (DMSO) instillation arm at 3 months due to withdrawal for reasons unrelated to study (cancer).||units on a scale||Standard Deviation|Mean
763114|NCT00667186|Secondary|Percentage Consenting to Testing|Percentage of those successfully offered testing who consent to testing|3 years|the number consenting to testing divided by the number offered testing||percentage of offered testing who consen|||Number
763115|NCT00667186|Primary|Percentage of Tested Participants Newly Diagnosed as HIV Infected|Percentage of tested participants newly diagnosed as HIV infected|3 years|participants analyzed is restricted to the participants that consented to testing||percentage of tested that are positive|||Number
763116|NCT00667225|Secondary|Mean Change in Each Group Measured by Lesion Count.|Average change in number of lesions from baseline to 8 weeks|Baseline compared to 8 weeks (5 visits)|||lesions||Standard Deviation|Mean
763117|NCT00667225|Primary|Patients Experiencing Complete Clearance of All Molluscum Lesions.||Baseline compared to 8 weeks (5 visits)|We used a power calculation to estimate the number of patients needed to detect a clinically significant result.||Participants|Participants||Number
763118|NCT00667251|Secondary|Economic Evaluation, Including Health Utilities, as Measured by the EQ-5D Questionnaire, and Healthcare Utilization||Not available at this time||||||
763119|NCT00667251|Secondary|Effects of Changes in Biomarkers on Clinical Outcomes||Not available at this time||||||
763120|NCT00667251|Secondary|Quality of Life as Measured by the EORTC QLQ-C30 Global Score From Baseline to 12 Weeks|The EORTC QLQ-C30 is a questionnaire developed to assess the quality of life of cancer patients. The global score ranges from 0-100, with higher values representing a better quality of life. At 12 weeks: Group mean difference between arms|12 weeks|||Score on global scale||Standard Deviation|Mean
763121|NCT00667251|Secondary|Clinical Benefit Response Rate (HER2/Neu+))|Best overall response of CR, PR, or stable disease at end of week 24.|24 weeks|||Participants|||Number
763122|NCT00667251|Secondary|Clinical Benefit Response Rate (ITT)|Best overall response of CR, PR or stable disease at end of week 24.|24 weeks|||Participants|||Number
763123|NCT00667251|Secondary|Overall Objective Response Rate (Complete or Partial) HER2/Neu+|Response determined by RECIST V 1.0|Median follow-up of 21.5 months.|||Participants|||Number
763124|NCT00667251|Secondary|Overall Objective Response Rate (Complete or Partial) ITT|Patients included in this assessment must have had at least one measurable lesion at baseline, and had at least one RECIST re-evaluation after baseline while on protocol therapy, prior to, or on, date of progression. Best overall response was classified to be Complete Response (CR) or Partial Response (PR).|4 years|||Participants|||Number
763125|NCT00667251|Secondary|CNS Metastases at the Time of Progression (HER2+)||Incidence rate of CNS mestastes at first progression, assessed up to 39 months|151 patients with metastases assessed for CNS metastases; 128 patients with metastases assessed for CNS metastases.||CNS metastases|||Number
763126|NCT00667251|Secondary|CNS Metastases at the Time of Progression (ITT)||Incidence rate of CNS metastases at first progression assessed up to 39 months|178 Lapatinib patients with metastases assessed for CNS metastases; 157 Trastuzumab patients with metastases assessed for CNS metastases.||CNS metastases|||Number
763127|NCT00667251|Secondary|Time to CNS Metastases at the Time of First Progression||From randomization to CNS metastases at time of first progression, assessed up to 39 months.|||Months||Full Range|Median
763129|NCT00667251|Primary|Progression-free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|From randomization to RECIST V 1.0 progression or death assessed up to 39 months.|two subpopulations: ITT (n=652) and HER2+ (n=537)||Months||Full Range|Median
763130|NCT00667277|Secondary|Number of Cycles|Number of cycles of bevacizumab received. Patients received bevacizumab as a single agent at a dose of 15 mg/kg intravenously on Day 1 of a 21-day cycle.|2 years|||cycles||Standard Deviation|Mean
763131|NCT00667277|Primary|Reason for Therapy Discontinuation|"Patient outcomes for myelofibrosis patients treated on a single agent bevacizumab.
The two subjects who withdrew consent prior to initiation of therapy are included in the patient refusal category."|2 years|||participants|||Number
763132|NCT00667342|Other Pre-specified|Mean Duration of Neuropathic Pain Medication|Thirty participants who underwent surgery (31 surgeries) were determined to have neuropathic pain. Four participants received only opioids for NP and 26 participants (for 27 surgeries) were treated with NP specific medications including gabapentin, tricyclic antidepressant, methadone. One participant had 2 different surgical procedures and was analyzed both in the limb sparing group and in the amputation group.|From surgery until resolution of NP symptoms, up to 6 months|||Weeks|Number of Surgeries|Standard Deviation|Mean
763133|NCT00667342|Other Pre-specified|Median Duration of Neuropathic Pain Medication|Thirty participants who underwent surgery (31 surgeries) were determined to have neuropathic pain (NP). Four participants received only opioids for NP and 26 participants (for 27 surgeries) were treated with NP specific medications including gabapentin, tricyclic antidepressant, methadone. One participant had 2 different surgical procedures and was analyzed both in the limb sparing group and in the amputation group.|From surgery until resolution of NP symptoms, up to 6 months|All participants who met the criteria, had surgery, experienced neuropathic pain and were treated with NP medication.||Weeks|Number of Surgeries|Full Range|Median
763134|NCT00667342|Other Pre-specified|Mean Duration of Neuropathic Pain|Thirty participants who underwent surgery (31 surgeries) were determined to have neuropathic pain (NP). Four participants received only opioids for NP and 26 participants (for 27 surgeries) were treated with NP specific medications including gabapentin, tricyclic antidepressant, methadone. One participant had 2 different surgical procedures and was analyzed both in the limb sparing group and in the amputation group.|From surgery until resolution of NP symptoms, up to 6 months|All participants who met the criteria, had surgery, experienced neuropathic pain and were treated with NP medication.||Weeks|Number of Surgeries|Standard Deviation|Mean
763135|NCT00667342|Other Pre-specified|Median Duration of Neuropathic Pain|Thirty participants who underwent surgery (31 surgeries) were determined to have neuropathic pain. Four participants received only opioids for NP and 26 participants (for 27 surgeries) were treated with NP specific medications including gabapentin, tricyclic antidepressant, methadone. One participant had 2 different surgical procedures and was analyzed both in the limb sparing group and in the amputation group.|From surgery until resolution of NP symptoms, up to 6 months|All participants who met the criteria, had definitive surgery (either limb sparing or/and amputation), experienced neuropathic pain (NP) and were treated for NP until resolution of NP symptoms and off NP medications.||Weeks|Number of Surgeries|Full Range|Median
763136|NCT00667342|Other Pre-specified|Number of Participants With Neuropathic Pain (NP) Following Surgery|Of the 43 participants enrolled on this trial, 37 met criteria for evaluation of neuropathic pain (NP) following definitive surgery. The 37 participants underwent 38 surgeries: one participant had a limb-sparing surgery followed by an amputation surgery. Six of 43 participants were excluded from evaluation for NP: 1 due to deep vein thrombosis, 2 removed from study prior to surgery, 1 removed immediately after surgery to receive radiation therapy, 1 had non-extremity osteosarcoma, and 1 patient had a fibula resection. Patients were followed for neuropathic pain daily for the first week postoperatively and weekly for up to 6 months postoperatively.|Up to 6 months postoperatively|||participants|Number of Surgeries||Number
763137|NCT00667342|Secondary|Difference Between Good and Poor Response by SUVmax|The response is based on the Huvos grade of histologic response for DCE-MRI comparisons and is defined as good for ≥90% necrosis and poor for less than 90%.|at week 10 after start of therapy|One participant with no histologic response but with evaluable imaging was excluded.||(unitless)||Standard Error|Mean
763138|NCT00667342|Secondary|P95 of Ktrans by Good and Poor Response|The response is based on the Huvos grade of histologic response for DCE-MRI comparisons and is defined as good for ≥90% necrosis and poor for less than 90%. P95 denotes the level of each kinetic parameter exceeding 95% of its values in each tumor.|at week 10 after start of therapy|Two Stratum A participants with no histologic response were excluded.||min(-1)||Standard Error|Mean
763139|NCT00667342|Secondary|Ktrans by Good and Poor Response|The response is based on the Huvos grade of histologic response for DCE-MRI comparisons and is defined as good for ≥90% necrosis and poor for less than 90%.|at week 10 after start of therapy|Two Stratum A participants with no histologic response were excluded.||min(-1)||Standard Error|Mean
763140|NCT00667342|Secondary|Histologic Response by Number of Participants|The association of interested variables with response was checked with the Wilcoxon rank-sum test. The response is based on the Huvos grade of histologic response for DCE-MRI comparisons and is defined as good for ≥90% necrosis and poor for less than 90%.|at week 10 after start of therapy|Two Stratum A participants with no histologic response were excluded.||Participants|||Count of Participants
763141|NCT00667342|Secondary|Mean Ve|The fractional volume of extravascular extracellular space (Ve) was used to evaluate clinical outcomes. The average for the distribution across the whole region of interest (ROI) was calculated as a summary measure for each data set.|Baseline through Week 10|The number analyzed at each time point differed due to missing observations at some of the time points||(unitless)||Standard Deviation|Mean
763142|NCT00667342|Secondary|Mean Vp|The fractional blood plasma volume (Vp) was used to evaluate clinical outcomes. The average for the distribution across the whole region of interest (ROI) was calculated as a summary measure for each data set.|Baseline through Week 10|The number analyzed at each time point differed due to missing observations at some of the time points||(unitless)||Standard Deviation|Mean
763143|NCT00667342|Secondary|Mean Ktrans|The volume transfer constant (Ktrans) was used to evaluate clinical outcomes. The average for the distribution across the whole region of interest (ROI) was calculated as a summary measure for each data set.|Baseline through Week 10|The number analyzed at each time point differed due to missing observations at some of the time points||min(-1)||Standard Deviation|Mean
763144|NCT00667342|Secondary|2-Year Overall Survival (OS) in Patients With Localized Resectable Disease Compared to OS99 Protocol.|The current protocol OS2008 (NCT00667342) was closed early due to slow accrual. Thus, with the limited number of patients, the comparison of EFS of OS2008 to that of OS99 (NCT00145639) participants was not done. The 2-year OS of OS2008 participants is reported here.|After all patients have completed therapy, up to 2 years after last patient is enrolled|OS2008 Localized Resectable Disease group had 31 participants: 7 were expired and 24 still alive||probability||95% Confidence Interval|Number
763145|NCT00667342|Secondary|2-Year Event Free Survival (EFS) in Patients With Localized Resectable Disease Compared to St. Jude OS99 Protocol.|The current protocol OS2008 (NCT00667342) was closed early due to slow accrual. Thus, with the limited number of patients, the comparison of EFS of OS20008 to that of OS99 (NCT00145639) participants was not done. The 2-year EFS of OS2008 participants is reported here.|After all patients have completed therapy, up to 2 years after last patient is enrolled|OS2008 Localized Resectable Disease group had 31 participants: 14 had events, 17 had no events.||probability||95% Confidence Interval|Number
763146|NCT00667342|Secondary|2-Year Overall Survival (OS) of Patients With Osteosarcoma|Kaplan-Meier method was used to estimate the OS of patients with osteosarcoma treated with chemotherapy and Bevacizumab.|After all patients have completed therapy, up to 2 years after last patient is enrolled|All the 42 evaluable participants in this study had osteosarcoma, of which 12 died and 20 were still alive as of 05/04/2015.||probability||95% Confidence Interval|Number
763147|NCT00667342|Secondary|2-Year Event Free Survival (EFS) of Patients With Osteosarcoma|Kaplan-Meier method was used to estimate the EFS of patients with osteosarcoma treated with chemotherapy and Bevacizumab.|After all patients have completed therapy, up to 2 years after last patient is enrolled|All the 42 evaluable participants were included in this analysis.||probability||95% Confidence Interval|Number
763148|NCT00667342|Secondary|Histologic Response by Stratum|"The effect of adding bevacizumab to preoperative chemotherapy comprised of cisplatin, doxorubicin, and HDMTX on the histologic response in patients with localized resectable osteosarcoma compared to historical controls treated with preoperative cisplatin, doxorubicin, and HDMTX without bevacizumab on the Intergroup Study 0133.
Histologic response at week 10 of therapy was evaluated by Huvos grading systems as grade I: tumor not responding to therapy, no effect identified; grade IIA: more than 50% viable tumor left; grade IIB: 5-50% viable tumor remaining; grade III: only scattered foci of viable tumor seen (less than 5% of tumor); grade IV: no viable tumor seen in extensive sampling (at least a full cross-section of the tumor).
The study did not enroll an adequate number of participants, therefore, the comparison to Intergroup Study 0133 participants was not done."|After 6 cycles of chemotherapy, up to 1 year after the start of therapy|All Stratum A participants were evaluated. The tumor sample for analysis was not obtained for one of the 12 Stratum C participants.||participants|||Number
763149|NCT00667342|Primary|3-Year Event Free Survival|To study the effect of adding bevacizumab to chemotherapy comprised of cisplatin, doxorubicin, and high-dose methotrexate (HDMTX) on the event-free survival (EFS) in patients with localized resectable osteosarcoma. The Kaplan-Meier (K-M) method was used to estimate survival rate.|After all patients have completed therapy, up to 4 years after last patient is enrolled|||Probability||95% Confidence Interval|Number
763150|NCT00667342|Primary|Number of Participants With Unacceptable Toxicity|"Objective: To study the feasibility of combining: 1) bevacizumab with cisplatin, doxorubicin, and high-dose methotrexate (MAP) in patients with localized resectable osteosarcoma; and 2) bevacizumab with MAP and ifosfamide, and etoposide in patients with unresectable or metastatic osteosarcoma.
The target unacceptable toxicity is defined as grade 4 hypertension, proteinuria, or bleeding excluding petechiae/purpura, grade 3/4 thrombosis/embolism excluding catheter-related thrombosis. The unacceptable toxicity for major wound complication is defined as grade 2, 3, or 4 major wound complications.
A six-stage group sequential stopping rule was developed for monitoring unacceptable toxicity."|After all patients have completed therapy, up to 1 year after last patient is enrolled|Due to slow accrual, the trial was closed to accrual early. Thus, only 31 stratum A patients and 12 stratum B or C patients were enrolled on the study. Therefore, based on the number of patients enrolled and the designed power for the study, we do not have confidence in making a conclusion regarding this feasibility objective.||participants|||Number
763151|NCT00667355|Secondary|Mean Change From Baseline in 36-Item Short Form (SF-36) Questionnaire|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These are summarized in a physical component summary (PCS) and mental component summary (MCS) score. The score for a section is an average of the individual question scores, which are scaled 0-100 (0=lowest level of functioning; 100=highest level of functioning).|Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on LOCF.||units on scale||95% Confidence Interval|Mean
763152|NCT00667355|Secondary|Mean Change From Baseline in Tender Joint Count for 46 Joints (TJC 46)|The number of tender or painful joints among 23 anatomical joints for both the right and left side of the body were assessed by a joint evaluator where the presence of a tender or painful joint was scored as 1 and absence as 0. The total TJC was derived by the sum of the scores for a range of TJC from 0 (best possible score; no tender or painful joints) to 46 (worst possible score; all joints tender or painful).|Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on LOCF.||TJC||95% Confidence Interval|Mean
763153|NCT00667355|Secondary|Mean Change From Baseline in Swollen Joint Count for 44 Joints (SJC 44)|The number of swollen joints among 22 anatomical joints for both the right and left side of the body were assessed by a joint evaluator where the presence of a swollen joint was scored as 1 and absence as 0. The total SJC was derived by the sum of the scores for a range of SJC from 0 (best possible score; no swollen joints) to 44 (worse possible score; all joints swollen).|Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on LOCF.||SJC||95% Confidence Interval|Mean
763154|NCT00667355|Secondary|Mean Change From Baseline in Nocturnal Pain|Nocturnal pain assessed by subjects using a Visual Analog Scale (VAS) of 0 – 100 mm (0 = no pain and 100 = worst possible pain).|Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on LOCF.||mm on scale||95% Confidence Interval|Mean
763183|NCT00667420|Primary|Safety and Tolerability|Safety and tolerability were measured by assessing the number of participants able to complete 3 cycles of pre-operative chemotherapy|after 3 cycles of pre-operative chemotherapy (approx 21 days per cycle)|||participants|||Number
763155|NCT00667355|Secondary|Mean Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)|Assessment of enthesitis was performed in the following 7 domains: 1) 1st costochondral joint left and right, 2) 7th costochondral joint left and right, 3) posterior superior iliac spine left and right, 4) anterior superior iliac spine left and right, 5) iliac crest left and right, 6) 5th lumbar spinous process and 7) proximal insertion of Achilles tendon left and right. Each domain was graded for the presence (1) and absence (0) of tenderness yielding total MASES ranging from 0 (no tenderness) to 13 (worst possible score; severe tenderness).|Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on LOCF.||units on a scale||95% Confidence Interval|Mean
763156|NCT00667355|Secondary|Mean Change From Baseline in Chest Expansion|Chest expansion is the difference in centimeters between full expiration and full inspiration, measured at the 4th inter-costal space. An increase in chest expansion represents improvement.|Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on LOCF.||cm||95% Confidence Interval|Mean
763157|NCT00667355|Secondary|Mean Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI)|BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: tragus to wall distance, lumbar flexion, cervical rotation, lumbar side flexion, and intermalleolar distance. Each measure was scored 0-2 (0=normal mobility/mild disease involvement, 1=moderate disease involvement, 2=severe disease involvement) to give a final total score ranging from 0 to 10. The higher the BASMI score, the more severe was the subject's limitation of movement due to their AS.|Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on LOCF.||units on scale||95% Confidence Interval|Mean
763158|NCT00667355|Secondary|Number of Subjects Achieving Assessment in Ankylosing Spondylitis Partial Remission|Partial remission is defined as a score of less than 20 units (on a scale of 0–100; 0=no disease activity and 100=high disease activity) in each of the 4 Assessments in Ankylosing Spondylitis (ASAS) domains: patient global assessment of disease activity, pain, function, and inflammation.|Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on NRI, for which subjects with a missing value at a visit were imputed as a non-responder for that visit.||Subjects|||Number
763159|NCT00667355|Secondary|Number of Subjects Achieving Assessment in Ankylosing Spondylitis 40 (ASAS 40)|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) subjects. ASAS = 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 40 = at least 40% improvement (vs. baseline) and an absolute improvement ≥ 20 units on a 0-100 scale (0 = no disease activity; 100 = high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on NRI, for which subjects with a missing value at a visit were imputed as a non-responder for that visit.||Subjects|||Number
763160|NCT00667355|Secondary|Number of Subjects Achieving Assessment in Ankylosing Spondylitis (ASAS) 5/6.|ASAS 5/6 consists of 6 domains: the 4 used in ASAS 20 (patient global assessment of disease activity, pain, function, inflammation) plus spinal mobility and an acute phase reactant, C Reactive Protein (CRP). Achieving ASAS 5/6 requires a 20% improvement compared to baseline in ≥ 5 domains (each domain measured on a 0 - 100 scale [0 = no disease activity; 100 = high disease activity]).|Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on NRI, for which subjects with a missing value at a visit were imputed as a non-responder for that visit.||Subjects|||Number
763161|NCT00667355|Secondary|Mean Change From Baseline in C-Reactive Protein (CRP)|CRP is a marker of inflammation and measured in mg/dL. A higher level is consistent with inflammation.|Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on LOCF.||mg/dL||95% Confidence Interval|Mean
763162|NCT00667355|Secondary|Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)|BASFI is a validated self assessment tool that determines the degree of functional limitation in AS subjects. Utilizing a VAS of 0–100 mm (0=easy, 100=impossible), subjects answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.|Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on last observation carried forward (LOCF).||mm on scale||95% Confidence Interval|Mean
763163|NCT00667355|Secondary|Mean Change From Baseline in Total Back Pain|Subject assessed his/her back pain by using a Visual Analog Scale (VAS) of 0 – 100 mm (0 = no pain and 100 = most severe pain).|Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on LOCF.||mm on scale||95% Confidence Interval|Mean
763164|NCT00667355|Secondary|Mean Change From Baseline in Patient's Global Assessment of Disease Activity|Subject's assessment of disease activity using a Visual Analog Scale (VAS) of 0 – 100 mm (0 = none and 100 = severe).|Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on LOCF.||mm on scale||95% Confidence Interval|Mean
763165|NCT00667355|Secondary|Number of Subjects Achieving Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI 50)|BASDAI is a validated self assessment tool used to determine disease activity in subjects with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) subjects answered 6 questions measuring discomfort, pain, fatigue, and morning stiffness. BASDAI 50 = at least 50% improvement (vs. baseline) in BASDAI.|Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on NRI, for which subjects with a missing value at a visit were imputed as a non-responder for that visit.||Subjects|||Number
763166|NCT00667355|Secondary|Number of Subjects Achieving ASAS 70|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) subjects. ASAS has 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 70 = at least 70% improvement (vs. baseline) and an absolute improvement ≥ 30 units on a 0-100 scale (0 = no disease activity; 100 = high disease activity) for ≥ 3 domains, and no worsening (defined as a worsening of ≥ 20% and a net worsening of ≥ 10 units) in the remaining domain.|Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on NRI, for which subjects with a missing value at a visit were imputed as a non-responder for that visit.||Subjects|||Number
763167|NCT00667355|Secondary|Number of Subjects Achieving ASAS 50|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) subjects. ASAS has 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 50 = at least 50% improvement (vs. baseline) and an absolute improvement ≥ 20 units on a 0-100 scale (0 = no disease activity; 100 = high disease activity) for ≥ 3 domains, and no worsening (defined as a worsening of ≥ 20% and a net worsening of ≥ 10 units) in the remaining domain.|Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on NRI, for which subjects with a missing value at a visit were imputed as a non-responder for that visit.||Subjects|||Number
763168|NCT00667355|Secondary|Number of Subjects Achieving ASAS 20|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) subjects. ASAS has 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement (vs. baseline) and an absolute improvement ≥ 10 units on a 0-100 scale (0 = no disease activity; 100 = high disease activity) for ≥ 3 domains, and no worsening (defined as a worsening of ≥ 20% and a net worsening of ≥ 10 units) in the remaining domain.|Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on non-responder imputation (NRI), for which subjects with a missing value at a visit were imputed as a non-responder for that visit.||Subjects|||Number
763169|NCT00667355|Primary|Number of Subjects Achieving Assessment in Ankylosing Spondylitis 20 (ASAS 20) at Week 12|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) subjects. ASAS has 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 20 = at least 20% improvement (vs. baseline) and an absolute improvement ≥ 10 units on a 0 - 100 scale (0 = no disease activity; 100 = high disease activity) for ≥ 3 domains, and no worsening (defined as a worsening of ≥ 20% and a net worsening of ≥ 10 units) in the remaining domain.|Week 12|For all non-responder imputation (NRI) analyses, subjects with a missing value at a visit were imputed as a non-responder for that visit. Observed cases is based on a total of 40 subjects analyzed (vs. 41 subjects for the study and all other analysis sets) due to 1 subject who discontinued prior to Week 12.||Subjects|||Number
763170|NCT00667368|Secondary|Percentage of Women Testing Positive for Bacterial Vaginosis (BV) Through 12 Months|Percentage of women testing positive for BV at any follow-up visit. The outcome of BV status was determined by self-collected vaginal swab specimens that were evaluated by the Nugent criteria. A Nugent score of 7-10 indicates positive for BV.|2, 4, 6, 8, 10, 12 months after enrollment|All randomized participants||percentage of participants|||Number
763171|NCT00667368|Primary|One-year Incidence of Chlamydial and Gonococcal Infections in Women Who Receive Screening (Every 2 Months) and Treatment for Asymptomatic Bacterial Vaginosis as Compared to a Control Group With Regular Monitoring (Every 2 Months) But no Treatment|Chlamydia and gonococcal infections were determined by vaginal swab testing collected at 4, 8, and 12 months after enrollment. Specimens were evaluated using the BD ProbeTec Amplified DNA AssayTM (Becton-Dickson, Inc. Sparks, MD). The primary outcome measure is the combined number of chlamydia and gonococcal infections.|At 4, 8, and 12 months after enrollment.|||Number infections per 100 person-years||95% Confidence Interval|Number
763172|NCT00667381|Other Pre-specified|Number of Patients With Successful Common Femoral Artery Placement, Among Those Patients With High Femoral Artery Bifurcations|Patients found to have femoral artery bifurcations occurring over the femoral head were prospectively defined as having a high femoral bifurcation. This subgroup was prespecified for analysis during the trial designed, as it was suspected that operators would have particular difficulty inserting the sheath accurately in this population.|At angiogram analysis|||participants|||Number
763173|NCT00667381|Secondary|Number of Participants With Vascular Complications|"Vascular complications were defined as vessel thrombosis, dissection, blood transfusion, hematoma > 5cm diameter, unexplained bleeding with a drop in Hgb >4 g/dL, or access site bleeding with drop in Hgb >3 g/dL.
Outcome was assessed by chart review, and clinical or telephone followup at 30 days. Medical records were adjudicated by a blinded independent review committee."|Immediate and up to 1 month after procedure.|||participants|||Number
763174|NCT00667381|Secondary|Number of Patients With Accidental Femoral Venipunctures.|"Number of patients with any femoral venipunctures where an insertion was not intended, i.e. excluding patients with planned right heart catheterization. Multiple accidental venipunctures were not double counted.
Number of attempts and venipunctures were not recorded in 1 control and 1 ultrasound patient, so the denominator is 500 control patients and 502 ultrasound patients."|Immediate|||participants|||Number
763175|NCT00667381|Secondary|Time to Successful Sheath Insertion.|"Time was measured from first fluoroscopy of the femoral head (control group), or first application of the ultrasound probe (ultrasound group), until successful sheath insertion.
Time was not recorded for 1 control patient, and 1 ultrasound patient, these patients were excluded from this analysis but included for other analyses."|Immediate|||seconds||Standard Deviation|Mean
763176|NCT00667381|Primary|Participants With Successful Common Femoral Artery Cannulation, as Determined by Femoral Angiography|"Femoral angiography was performed in 490 control patients and 499 ultrasound patients. In 11 control and 4 ultrasound patients, femoral angiography was either not performed or was inadequate for analysis. These patients were excluded from the primary outcome analysis but included for other analyses.
Successful common femoral artery cannulation was defined as sheath insertion above the bifurcation of the common femoral artery and below the origin of the inferior epigastric artery. Unsuccessful sheath insertion was defined as sheath insertion outside of these markers."|Immediately, during procedure.|||participants|||Number
763177|NCT00667394|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|45 months|||Participants|||Number
763178|NCT00667394|Primary|Progression-free Survival at 6 Months|Percentage of participants with progression free survival at 6 months. Progression is defined as a 25% increase in the sum of all measurable lesions (or two largest lesions if too numerous) over the smallest sum observed (over baseline if no decrease), clear worsening of any evaluable disease, appearance of any new lesion/site, or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).|6 months|||Percentage of participants||95% Confidence Interval|Median
763179|NCT00667420|Secondary|Overall Survival|Overall survival (OS) is the duration from start of treatment to time of death from any cause.|duration from enrollment to death (up to 6 years)|||months||95% Confidence Interval|Median
763180|NCT00667420|Secondary|Pathologic Complete Response Rate|For patients who undergo complete resection, those who have no evidence of residual viable tumor in the surgical specimen will be declared to have achieved a complete pathologic response (pCR), and the overall percentage of patients with pCR will be determined.|at surgical resection, after 3 cycles pre-operative chemotherapy (approx 63 days)|||participants|||Number
763181|NCT00667420|Secondary|Progression-Free Survival|measured from the first day of treatment to the day when conclusive evidence of new disease is found|up to 72 months|We enrolled 17 patients||months||Standard Deviation|Mean
763182|NCT00667420|Secondary|R0 Resection Rate|percentage of participants who have microscopically negative margins (no tumor at/near the edge of what is resected) at the time of surgical resection|time of surgery = after 3 cycles (approx 63 days) of pre-operative EOX-P chemotherapy|||percentage of participants|||Number
763184|NCT00667446|Secondary|Ratio of Change From Baseline in Bone Age/Change From Baseline in Chronological Age|"Bone age was determined by left hand/wrist bone age radiographs that were evaluated using the Fels Method by a central reader. The ratio of change from Baseline in bone age (BA)/change from Baseline in chronological age (CA) was calculated using the following formula:
(BA at Post-baseline Treatment Visit - BA at Baseline) / (CA at Post-baseline Treatment Visit - CA at Baseline)."|Baseline (of the lead-in study L-CP07-167), and Day 1, Months 12, 24, and 36|Intention-to-treat with available bone age data. N = participants with available data at each time point.||ratio||Standard Deviation|Mean
763185|NCT00667446|Secondary|Change From Baseline in Growth Rate|Baseline growth rate was the growth rate in the one year prior to Day 1 of the lead-in study L-CP07-167. Growth rates were calculated as the ratio of the change in height to the change in chronological age with an approximate 6-month interval for Day 1, Months 6, 12, 18, 24, 30, 36 and the Final Treatment Visit.|Baseline (the 1 year prior to the start of treatment in the lead-in study), and Day 1, Months 6, 12, 18, 24, 30, and 36|Intention-to-treat with available growth rate data. N = participants with available data at each time point.||cm/year||Standard Deviation|Mean
763186|NCT00667446|Secondary|Percentage of Male Participants With Suppression of the Physical Signs of Puberty (Testicular Volume and Genital Development)|The percentage of male participants with suppression of testicular volume and genital staging. Testicular volume was calculated from the length, width and height of each testicle measured by ultrasound. External genital development (testes and penis) was rated from Stage 1 (early development) through Stage 5 (full development) according to a modified Tanner Staging pictogram. Suppression is defined as regression or no progression in both testicular volume and genital staging from Baseline (of the lead-in study L-CP07-167) according to pubertal staging. Boys entering the study with fully developed genitals (Stage 5) were excluded from this analysis. Final visit is the participant's last visit closest to Month 36.|Baseline (of the lead-in study L-CP07-167), Day 1, Months 3, 6, 9, 12, 18, 24, 30, and 36|Intention-to-treat male population, excluding participants who entered the study at Stage 5. N = the number of participants with available data at each time point.||percentage of participants||95% Confidence Interval|Number
763187|NCT00667446|Secondary|Percentage of Female Participants With Suppression of the Physical Signs of Puberty (Breast Development)|The percentage of female participants with suppression of breast development. Breast development was rated from Stage 1 (early development) through Stage 5 (full development) according to a modified Tanner Staging pictogram. Suppression of breast development is defined as regression or no progression of breast development from Baseline (of the lead-in study L-CP07-167) according to pubertal staging. Girls entering the study with fully developed breasts (Stage 5) were excluded from this analysis. Final visit is the participant's last visit closest to Month 36.|Baseline (of the lead-in study L-CP07-167), Day 1, Months 3, 6, 9, 12, 18, 24, 30, and 36|Intention-to-treat female population, excluding participants who entered the study at Stage 5. N = the number of participants with available data at each time point.||percentage of participants||95% Confidence Interval|Number
763188|NCT00667446|Secondary|Mean Peak-stimulated Luteinizing Hormone Concentration by Visit|Peak-stimulated luteinizing hormone refers to the maximum luteinizing hormone concentration measured 30 and 60 minutes after a gonadotropin-releasing hormone agonist (GnRHa) stimulation test. Final visit is the participant's last visit closest to Month 36.|Baseline of the lead-in study L-CP07-167, Day 1, Months 6, 12, 24, and 36|Intention-to-treat. N = the number of participants with available data at each time point.||mIU/mL||Standard Deviation|Mean
763189|NCT00667446|Secondary|Percentage of Male Participants With Suppression of Basal Testosterone|The percentage of male participants with suppression of basal testosterone to prepubertal levels, defined as testosterone < 30 ng/dL. Final visit is the participant's last visit closest to Month 36.|Day 1, Months 3, 6, 9, 12, 24, 30, and 36|Intention-to-treat male population. N = the number of participants with available data at each time point.||percentage of participants||95% Confidence Interval|Number
763190|NCT00667446|Secondary|Percentage of Female Participants With Suppression of Basal Estradiol (Assay 2)|"The percentage of female participants with suppression of basal estradiol to prepubertal levels, defined as estradiol < 20 pg/mL.
The estradiol assay was changed in June of 2010, and the lower limit of quantitation (LLOQ) was increased from 1 pg/mL to 10 pg/mL. This outcome measure reports data for assays performed after this change occurred, with an LLOQ of 10 pg/mL. Final visit is the participant's last visit closest to Month 36."|Months 6, 9, 12, 24, 30, and 36|Intention-to-treat female population. N = the number of participants with available data at each time point.||percentage of participants||95% Confidence Interval|Number
763191|NCT00667446|Secondary|Percentage of Female Participants With Suppression of Basal Estradiol (Assay 1)|"The percentage of female participants with suppression of basal estradiol to prepubertal levels, defined as estradiol < 20 pg/mL.
The estradiol assay was changed in June of 2010, and the lower limit of quantitation (LLOQ) was increased from 1 pg/mL to 10 pg/mL. This outcome measure reports data for assays performed before this change occurred, with an LLOQ of 1 pg/mL. Final visit is the participant's last visit closest to Month 36."|Day 1, Months 3, 6, 9, 12, and 24|Intention-to-treat female population. N = the number of participants with available data at each time point.||percentage of participants||95% Confidence Interval|Number
763192|NCT00667446|Primary|Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone|Luteinizing Hormone (LH) suppression is defined as peak-stimulated LH < 4 mIU/mL. Peak-stimulated LH refers to the maximum LH concentration measured 30 and 60 minutes after a gonadotropin-releasing hormone agonist (GnRHa) stimulation test. Participants who failed suppression at previous visit and prematurely discontinued were counted as having failed future visits also. Final visit is the participant's last visit closest to Month 36.|Day 1, Months 6, 12, 24, and 36|Intention-to-treat, defined as patients who received at least 1 dose of study drug with at least 1 post-baseline measurement of any maintenance of suppression variable, & did not prematurely discontinue in the 1st 30 days due to inadequate suppression at Month 6 of the lead-in study. N= the number of patients with available data at each time point.||percentage of participants||95% Confidence Interval|Number
763204|NCT00667459|Secondary|Success Rate of SF-36 PCS|Success rate of SF-36 Health Survey include two components: the success rate of a physical component summary (PCS) and the success rate of a mental component summary (MCS). The success of SF-36 PCS was defined as: Post Score - Pre Score >= 0. The Success rate of SF-36 PCS is reported as the percentage of the participants who were classified as a success for SF-36 PCS.|24 months|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable SF-36 PCS success status at 24 months, which leads to 264 subjects in the investigational group and 216 subjects in the control group.||percentage of participants|||Number
763193|NCT00667459|Secondary|Change of General Health Status -- SF-36 MCS From Baseline|The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for MCS was between 0 and 100, with higher scores denoting better quality of life. Change of SF-36 MCS score was defined as MCS score at 24 months minus MCS score at baseline.|Baseline and 24 months post-operation|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable MCS score at both baseline and 24 months, which leads to 264 subjects in the investigational group and 216 subjects in the control group.||units on a scale||Standard Deviation|Mean
763194|NCT00667459|Secondary|Change of General Health Status -- SF-36 PCS From Baseline|The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS was between 0 and 100, with higher scores denoting better quality of life. Change of SF-36 PCS score was defined as PCS score at 24 months minus PCS score at baseline.|Baseline and 24 months post-operation|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable PCS score at both baseline and 24 months, which leads to 264 subjects in the investigational group and 216 subjects in the control group.||units on a scale||Standard Deviation|Mean
763195|NCT00667459|Secondary|Change of Arm Pain Score From Baseline|"Numerical rating scales were also used to evaluate arm pain intensity and frequency. Patients rated their arm pain intensity on a scale from 0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be. Similarly, patients recorded their arm pain frequency on a scale from 0-10, with a score of 0 being pain none of the time and a score of 10 being pain all of the time. The total arm pain score (0 to 100) was the product of pain intensity and frequency scores. Change of arm pain score was defined as arm pain score at 24 months minus arm pain score at baseline."|Baseline and 24 months post-operation|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable arm pain score at both baseline and 24 months, which leads to 268 subjects in the investigational group and 219 subjects in the control group.||units on a scale||Standard Deviation|Mean
763196|NCT00667459|Secondary|Change of Neck Pain Score From Baseline|"Numerical rating scales were used to evaluate neck pain intensity and frequency. Patients rated their neck pain intensity on a scale from 0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be. Similarly, patients recorded their neck pain frequency on a scale from 0-10, with a score of 0 being pain none of the time and a score of 10 being pain all of the time. The total neck pain score (0 to100) was the product of pain intensity and frequency scores. Change of neck pain score was defined as neck pain score at 24 months minus neck pain score at baseline."|Baseline and 24 months post-operation|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable neck pain score at both baseline and 24 months, which leads to 270 subjects in the investigational group and 219 subjects in the control group.||units on a scale||Standard Deviation|Mean
763197|NCT00667459|Secondary|Change of Neck Disability Index Score From Baseline|The self-administered Neck Disability Index (NDI) Questionnaire was used to assess patient neck pain and ability to function. The NDI scale ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability). Change of NDI was defined as NDI at 24 month minus NDI at baseline.|Baseline and 24 months post-operation|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable NDI score at both baseline and 24 months, which leads to 270 subjects in the investigational group and 219 subjects in the control group.||units on a scale||Standard Deviation|Mean
763198|NCT00667459|Secondary|Rate of Secondary Surgery at Index Level|Secondary surgical procedures at the index level included revisions, removals, supplemental fixations and reoperations. Rate of secondary surgery at index level is reported as percentage of patients who had secondary surgeries at index level.|24 months post-operation|For this endpoint, the analysis consists of all subjects in the primary analysis dataset with 280 subjects in the investigational control and 265 subjects in the control group.||percentage of participants|||Number
763199|NCT00667459|Secondary|Hospital Stay||During the time of hospital stay, average of 1 day.|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable information for hospital stay, which leads to 280 subjects in the investigational group and 265 subjects in the control group.||days||Standard Deviation|Mean
763200|NCT00667459|Secondary|Blood Loss||During the time of operation, approximately 1.5 hours.|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable information for blood loss, which leads to 278 subjects in the investigational group and 263 subjects in the control group.||ml||Standard Deviation|Mean
763201|NCT00667459|Secondary|Operative Time|Operative time was recorded from skin incision to wound closure.|Time of operation, approximately 1.5 hrs.|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable information for operative time, which leads to 280 subjects in the investigational group and 265 subjects in the control group.||hrs||Standard Deviation|Mean
763202|NCT00667459|Secondary|Gait Success Rate|Patient's gait was assessed by using Nurick's classification, and indicated either as normal or graded on a scale of 0 to 5. Success was defined as maintenance or improvement in the postoperative status as compared to the preoperative condition: Preoperative Score - Postoperative Score >= 0. The gait success rate is reported as the percentage of participants who had gait success.|24 months|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable gait success status at 24 months, which leads to 270 subjects in the investigational group and 220 subjects in the control group.||percentage of participants|||Number
763203|NCT00667459|Secondary|Success Rate of SF-36 MCS|Success rate of SF-36 Health Survey include two components: the success rate of a physical component summary (PCS) and the success rate of a mental component summary (MCS). The success of SF-36 MCS were defined as: Post Score - Pre Score >= 0. The Success rate of SF-36 MCS is reported as the percentage of the participants who were classified as a success for SF-36 MCS.|24 months|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable SF-36 MCS success status at 24 months, which leads to 264 subjects in the investigational group and 216 subjects in the control group.||percentage of participants|||Number
767745|NCT00697593|Primary|Hematology - Hemoglobin|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 3 participants missing values||g/L||Standard Deviation|Mean
763205|NCT00667459|Secondary|Arm Pain Success Rate|"Numerical rating scales were used to evaluate pain intensity and frequency. The pain score (0 min, 100 max) was derived by multiplying the numerical rating scores from the pain intensity (0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be.) and frequency scales (0-10, with a score of 0 being pain none of the time and a score of 10 being pain all of the time). Arm pain success rate is reported as the percentage of participants whose arm pain improvement met: Preoperative Score - Postoperative Score > 0."|24 months|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable arm pain success status at 24 months, which leads to 268 subjects in the investigational group and 219 subjects in the control group.||percentage of participants|||Number
763206|NCT00667459|Secondary|Neck Pain Success Rate|"Numerical rating scales were used to evaluate pain intensity and frequency. The pain score (0 min, 100 max) was derived by multiplying the numerical rating scores from the pain intensity (0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be.) and frequency scales (0-10, with a score of 0 being pain none of the time and a score of 10 being pain all of the time). Neck pain success rate is reported as the percentage of participants whose neck pain improvement met: Preoperative Score - Postoperative Score > 0."|24 months|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable neck pain success status at 24 months, which leads to 270 subjects in the investigational group and 219 subjects in the control group.||percentage of participants|||Number
763207|NCT00667459|Secondary|Rate of Disc Height Success|Disc height was assessed by determining the Functional Spinal Unit (FSU) height. The rate of disc height success is reported as the percentage of participants whose disc height for each level based on either the anterior or posterior measurements met the following criterion: Postoperative Height - 6 Week Postoperative Height >= -2mm|24 months|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable disc height success (FSU success) status at 24 months, which leads to 224 subjects in the investigational group and 164 subjects in the control group.||percentage of participants|||Number
763208|NCT00667459|Secondary|Success Rate of Neurological Status|Success rate of neurological status is reported as the percentage of participants who met neurological success defined as maintenance or improvement in all sections (motor, sensory, and reflexes) for the time period evaluated. In order for a section to be considered a success, each element in the section must remain the same or improve from the time of the preoperative evaluation to the time period evaluated.|24 months|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable neurological success status at 24 months, which leads to 270 subjects in the investigational group and 220 subjects in the control group.||percentage of participants|||Number
763209|NCT00667459|Secondary|Success Rate of Neck Disability Index|Success rate of Neck Disability Index is reported as the percentage of participants whose neck disability index score met: Pre-treatment Score - Post-treatment Score ≥ 15.|24 months|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable NDI success status at 24 months, which leads to 270 subjects in the investigational group and 219 subjects in the control group.||percentage of participants|||Number
763210|NCT00667459|Primary|Rate of Overall Success|"Rate of overall success is reported as the percentage of participants who met all of the following criteria:
Postoperative Neck Disability Index score improvement of at least a 15-points from preoperative;
Maintenance or improvement in neurological status;
Disc height success which was defined as either the anterior or posterior measurements meeting the criteria of “Postoperative Height - 6 Week Postoperative Height ≥ -2mm”;
No serious adverse event classified as implant associated or implant/surgical procedure associated; and
No secondary surgical procedure classified as a failure."|24 months|The primary analysis dataset for this study consists of all subjects who received study devices and completed the initial surgical procedures. The analysis was based on the observed data and missing data due to lost-to-follow-ups were imputed. For the primary endpoint, the analysis consists of 226 investigational subjects and 171 control subjects.||percentage of participants|||Number
763211|NCT00667511|Primary|Primary Safety: Compare the Composite Intradialytic and Interdialytic Adverse Event Profile in the Nocturnal Hemodialysis and Short Daily Hemodialysis Phases.|The primary safety endpoint for the study was the composite intradialytic and interdialytic adverse event (AE) profile.|Study Week 20|Includes all patient reported treatments.||events per 100 treatments|Participants||Number
763212|NCT00667511|Primary|Primary Efficacy: Compare the Ability to Deliver the Clinically Prescribed Amount of Therapy in the Nocturnal Hemodialysis and Short Daily Hemodialysis Phases.|The primary efficacy endpoint for the study was the ability to deliver the clinically prescribed amount of therapy, defined by attainment of a delivered volume that was at least 90% of the prescribed volume (10% difference in success rate is the upper boundary of the 95% confidence interval).|Study Week 20|Includes all electronically captured treatments.||percentage of successful treatments|Participants|95% Confidence Interval|Number
763213|NCT00667563|Primary|Number of Patients With Detectable Antibodies to HPV-18|Detectable antibodies to HPV-18 among participants with undetectable antibodies to HPV-18 at baseline|28 weeks|Per-protocol population of participants with undetectable HPV-18 antibodies at baseline||participants|||Number
763214|NCT00667563|Primary|Number of Patients With Detectable Antibodies to HPV-11|Detectable antibodies to HPV-11 among those who had undetectable antibodies to HPV-11 at baseline|28 weeks|Per-protocol population of participants with undetectable antibodies for HPV-11 at baseline||participants|||Number
763215|NCT00667563|Primary|Number of Patients With Detectable Antibodies to HPV-6|Detectable antibodies to HPV-6 among participant who had undetectable antibodies to HPV-6 at baseline|28 weeks|Per-protocol participants with undetectable antibodies to HPV-6 at baseline||participants|||Number
763216|NCT00667563|Primary|Number of Patients With a Significant Increase in HIV Viral Load|Number of patients with a significant increase in HIV viral load defined as > 1 log increase in HIV load from baseline on 2 consecutive occasions|Screening/week 0, weeks, 2, 10, 26 and 52|||participants|||Number
763217|NCT00667563|Primary|Number of Patients With Detectable HPV Antibodies to HPV 16 at Week 28|Number of participants with detectable HPV antibody to HPV 16 among those with undetectable antibodies to HPV 16 at baseline|Week 28|Per-protocol population with undetectable HPV-16 levels at baseline||participants|||Number
767371|NCT00694122|Secondary|Glucagon|Mean glucagon mcg/l during NPH or glargine (Lantus) overnight visit. Hourly glucagon was determined from 22:00 to 8:00.|Overnight|Participants completing both overnight visits were included in the analysis.||mcg/l||Standard Deviation|Mean
763218|NCT00667563|Primary|Number of Patients With Significant Decrease (at the 0.05 Significance Level) in CD4+ Cell Count|Significant decrease (at the 0.05 significance level) in CD4+ cell count to 75% of the baseline level on two or more consecutive tests|Screening/Week 0, Weeks 2, 10, 26, and 52.|Intent-to-treat||participants|||Number
763219|NCT00667563|Primary|Safety, in Terms of Grade 3 or 4 Adverse Events Attributed to the Vaccine, According to NCI CTCAE v3.0|Number of grade 3 or 4 adverse events attributed to vaccine per 100 patients|52 weeks from study entry|Intent-to-treat||Grade 3/4 adverse events per 100 patient||95% Confidence Interval|Number
763220|NCT00667576|Secondary|Duration of 2 Consecutive Intact Parathyroid Hormone (iPTH) Values ≤ 180 pg/mL||Through Week 13|Includes subjects from the Full Analysis Set (FAS) who had 2 consecutive iPTH values ≤ 180 pg/mL. Missing data were not imputed.||days||Standard Deviation|Mean
763221|NCT00667576|Secondary|Duration of 2 Consecutive Decreases of ≥ 50% From Baseline in Intact Parathyroid Hormone (iPTH) Values||Through Week 13|Includes subjects from the Full Analysis Set (FAS) who had 2 consecutive iPTH decreases of ≥ 50% from baseline. Missing data were not imputed.||days||Standard Deviation|Mean
763222|NCT00667576|Secondary|Percentage of Subjects With 2 or More Decreases of ≥ 50% From Baseline in Intact Parathyroid Hormone (iPTH) Level||Through Week 13|The efficacy analysis was performed on the full analysis set (FAS). The FAS included all treated subjects, except for 1 subject from the paricalcitol 4 ± 2 µg group who discontinued the study without measurement of iPTH after the first drug injection. Missing data were not imputed.||Percentage of participants|||Number
763223|NCT00667576|Secondary|Percentage of Subjects With Intact Parathyroid Hormone (iPTH) ≤ 180 Picograms/Milliliter (pg/mL)||Baseline to Week 13 (Final Visit)|The efficacy analysis was performed on the full analysis set (FAS). The FAS included all treated patients, except for 1 subject from the paricalcitol 4 ± 2 µg group who discontinued the study without measurement of iPTH after the first drug injection. Missing data were not imputed.||Percentage of participants|||Number
763224|NCT00667576|Secondary|Mean Change From Baseline in Intact Parathyroid Hormone (iPTH) Level||Baseline to Week 13 (Final Visit)|The efficacy analysis was performed on the full analysis set (FAS). The FAS included all treated patients, except for 1 subject from the paricalcitol 4 ± 2 µg group who discontinued the study without measurement of iPTH after the first drug injection. Missing data were not imputed.||pg/mL||95% Confidence Interval|Mean
763225|NCT00667576|Other Pre-specified|Percentage of Subjects With Hyperphosphatemia|Hyperphosphatemia was defined as at least 2 consecutive phosphorus values ≥ 7.0 mg/dL|Through Week 13|Safety analysis was performed on the Safety Set, which included all subjects who received at least 1 dose of study drug. Missing data were not imputed.||Percentage of participants|||Number
763226|NCT00667576|Other Pre-specified|Percentage of Subjects With Hypercalcemia|Hypercalcemia was defined as at least 1 adjusted calcium value > 11.5 mg/dL or at least 2 consecutive adjusted calcium values ≥ 11.0 mg/dL|Through Week 13|Safety analysis was performed on the Safety Set, which included all subjects who received at least 1 dose of study drug. Missing data were not imputed.||Percentage of participants|||Number
763227|NCT00667576|Primary|Percentage of Subjects With ≥ 50% Decrease From Baseline in Intact Parathyroid Hormone (iPTH) Serum Level||Baseline to Week 13 (Final Visit)|The efficacy analysis was performed on the full analysis set (FAS). The FAS included all treated patients, except for 1 subject from the paricalcitol 4 ± 2 µg group who discontinued the study without measurement of iPTH after the first drug injection. Missing data were not imputed.||Percentage of participants|||Number
763228|NCT00667589|Secondary|Change in Skindex-16 Total Score Between Baseline and 2 Weeks|The Skindex-16 questionnaire contains 16 questions related to quality of life in patients with skin disease. Total scores may range from 0 to 96, where 0 is associated with a better quality of life and 96 is associated with a worse quality of life. The data provided below indicates the change in the Skindex-16 total score between baseline and at 2 weeks.|baseline and 2 weeks|Results for one subject from the Tazarotene 0.1% cream arm and one subject from the Urea 40% cream arm are not included in analysis because these subjects did not completed a Skindex-16 questionnaire at 2 weeks. No subjects were randomized to the Udderly Smooth Emollient arm.||units on a scale||Standard Deviation|Mean
763229|NCT00667589|Primary|Change in Skindex-16 Total Score Between Baseline and 8 Weeks|The Skindex-16 questionnaire contains 16 questions related to quality of life in patients with skin disease. Total scores may range from 0 to 96, where 0 is associated with a better quality of life and 96 is associated with a worse quality of life. The data provided below indicates the change in the Skindex-16 total score between baseline and at 8 weeks.|baseline and 8 weeks|Results for subjects from the fluocinonide 0.05% cream arm, subjects from the Tazarotene 0.1% cream arm, and one subject from the Urea 40% cream arm are not included in analysis because these subjects did not complete a Skindex-16 questionnaire at 8 weeks. No subjects were randomized to the Udderly Smooth Emollient arm.||units on a scale|||Number
763230|NCT00667602|Secondary|Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 to Day 7 Postvaccination), After Any Vaccination|"Safety was assessed as the number of subjects who reported solicited local reactions from day 1 to day 7 postvaccination for all the three vaccination groups.
safety was assessed as the number of subjects who reported solicited systemic reactions from day 1 to day 7 Following the Month 12 vaccination in all three vaccination groups"|From day 1 to day 7 postvaccination|Analysis was done on the safety dataset, i.e. the subjects in the exposed population who provided postvaccination safety data.||Number of subjects|||Number
763231|NCT00667602|Secondary|Rabbit Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup A, W, Y|"Immunogenicity of one dose of MenACWY-CRM197 to one dose of MenC vaccine at 12 months of age was assessed with GMT of SBA with rabbit complement (rSBA) against Serogroup A, W, Y.
Immunogenicity of two doses of MenACWY-CRM197 to one dose of MenC vaccine at 6 to 8 and 12 months of age was assessed with geometric mean titer (GMT) of serum bactericidal assay with rabbit complement (rSBA) against Serogroup A, W, Y."|1 month postvaccination.|Analysis was done on PP set.||Titers||95% Confidence Interval|Geometric Mean
763232|NCT00667602|Secondary|Rabbit Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup C|"Immunogenicity of one dose of MenACWY-CRM197 to one dose of MenC vaccine at 12 months of age was assessed with geometric mean titer (GMT) of serum bactericidal assay with rabbit complement (rSBA) against Serogroup C.
Immunogenicity of two doses of MenACWY-CRM197 to one dose of MenC vaccine at 6 to 8 and 12 months of age was assessed with geometric mean titer (GMT) of serum bactericidal assay with rabbit complement (rSBA) against Serogroup C."|1 month postvaccination.|Analysis was done on PP set.||Titers||95% Confidence Interval|Geometric Mean
763233|NCT00667602|Secondary|Percentages of Subjects With Rabbit Serum Bactericidal ≥ 1:8, ≥ 1:128, and Four Fold Rise Against N.Meningitidis Serogroup A, W, Y|"Immunogenicity of one dose of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was assessed as percentages of subjects with serum bactericidal titer with rabbit complement (rSBA) ≥ 1:8, ≥ 1:128, and four fold rise in titer against N.meningitidis Serogroup A, W, Y.
Immunogenicity of two doses of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was assessed as percentages of subjects with serum bactericidal titer with rabbit complement (rSBA) ≥ 1:8, ≥ 1:128, and four fold rise in titer against N.meningitidis Serogroup A, W, Y."|1 month postvaccination.|Analysis was done on PP set.||Percentages of subjects||95% Confidence Interval|Number
763234|NCT00667602|Secondary|Percentages of Subjects With Rabbit Serum Bactericidal ≥ 1:8, ≥ 1:128 and Four Fold Rise Against N.Meningitidis Serogroup C|"Immunogenicity of one dose of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was assessed as percentages of subjects with serum bactericidal titer with rabbit complement (rSBA) ≥ 1:8, ≥ 1:128, and four fold rise in titer against N.meningitidis Serogroup C.
Immunogenicity of two doses of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was assessed as percentages of subjects with serum bactericidal titer with rabbit complement (rSBA) ≥ 1:8, ≥ 1:128, and four fold rise in titer against N.meningitidis Serogroup C."|1 month postvaccination.|Analysis was done on PP set.||Percentages of subjects||95% Confidence Interval|Number
763235|NCT00667602|Secondary|Persistence of Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, W, Y|Immunogenicity of two doses of MenACWY to one dose of MenACWY as measured by hSBA GMTs directed against N.meningitidis serogroups A, W, Y (only for subjects enrolled in Australia).|6-18 months postvaccination.|Analysis was done on PP set (only for subjects enrolled in Australia).||Titers||95% Confidence Interval|Geometric Mean
763236|NCT00667602|Secondary|Persistence of Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup C|Persistence of immunogenicity of either one or two doses of MenACWY or one dose of MenC as measured by human serum bactericidal activity geometric mean titers directed against N.meningitidis serogroup C (only for subjects enrolled in Australia).|1 month postvaccination and 6-18 months postvaccination.|Analysis was done on PP set (subjects enrolled in Australia).||Titers||95% Confidence Interval|Geometric Mean
763237|NCT00667602|Secondary|Persistence of Immune Response Measured as Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 ,and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, W, Y|Persistence of immune response to either one or two doses of MenACWY-CRM197 or one dose of MenC as measured by serum bactericidal assay with human complement (hSBA) titer ≥ 1:8 and titer ≥ 1:4 directed against N. meningitidis serogroups A, W and Y (only for subjects enrolled in Australia).|1 month postvaccination 6-18 months postvaccination|Analysis was done on PP set (persistence subset).||Percentages of subjects||95% Confidence Interval|Number
763238|NCT00667602|Secondary|Persistence of Immune Response Measured as Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroup C|Persistence of immune response to either one or two doses of MenACWY-CRM197 or one dose of MenC as measured by serum bactericidal assay with human complement (hSBA) titers ≥ 1:8, and titers ≥ 1:4 directed against N.meningitidis serogroup C (only for subjects enrolled in Australia).|1 month postvaccination and 6-18 months postvaccination.|Analysis was done on PP set (persistence subgroup).||Percentages of subjects||95% Confidence Interval|Number
763239|NCT00667602|Secondary|Percentages of Subjects With Seroresponse Rates After One Dose of PCV7 (Concomitant Vaccine)|"To compare the immunogenicity of PCV7 (Pneumococcal 7-valent Conjugate)Vaccine when given concomitantly with one dose or two doses of MenACWY-CRM197 or with MenC to infants at 12 months of age.
Seroresponse for PCV7 (PnC 4, PnC 6B, PnC 9V, PnC 14, PnC 18C, PnC 19F, PnC 23F) is defined as: a subject with primary endpoint ELISA ≥ 0.35 mcg/mL and secondary endpoint ELISA ≥ 1.0 mcg/mL."|1 month postvaccination|Analysis was done on PP set.||Percentages of subjects||95% Confidence Interval|Number
763240|NCT00667602|Secondary|Percentages of Subjects With Seroresponse Rates After One Dose of DTPa-IPV-HepB-Hib (Concomitant Vaccine)|"The immunogenicity of one dose of MenC to one dose of DTPa-IPV-HepB-Hib concomitant vacccine was assessed.
For Pertussis antigens, Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN), the seroresponse in initially seronegative subjects (pre-vaccination antibody concentration < LLQ) is defined as post-vaccination antibody concentration >= LLQ; in initially seropositive subjects (pre-vaccination antibody concentration >=LLQ) seroresponse is defined as at least two fold increase of the pre-vaccination antibody concentration.
Diptheria and Tetanus: primary endpoint ELISA (Enzyme-linked immunosorbent assay) >=0.1 (international unit -IU) IU/mL and the secondary endpoint is ELISA>=1.0 IU/mL.
Polio type 1, 2 and 3: bNT (neutralization test) with >=1:8.
HepB (HBV): primary endpoint ELISA >=10mU/mL.
PRP-T: primary endpoint ≥ 0.15 mcg/mL and ≥ 1.00 mcg/mL."|1 month postvaccination|Analysis was done on PP set.||Percentages of subjects||95% Confidence Interval|Number
763241|NCT00667602|Secondary|Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W, Y|"The immunogenicity of two doses of MenACWY-CRM197, to a single dose of MenC was assessed and compared as measured by human Serum Bactericidal Activity Geometric Mean Titers directed against N. meningitidis serogroup C.
The immunogenicity of two doses of MenACWY-CRM197, to a single dose of MenC was assessed as measured by human Serum Bactericidal Activity Geometric Mean Titers directed against N. meningitidis serogroups A, W, Y."|1 month postvaccination|Analysis was done on PP set.||Titers||95% Confidence Interval|Geometric Mean
763242|NCT00667602|Secondary|Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, W, Y|Immunogenicity of one dose of MenACWY-CRM197 one month postvaccination was assessed with GMT of serum bactericidal assay with hSBA against Serogroups A, W, Y.|1 month postvaccination|Analysis was done on PP set.||Titers||95% Confidence Interval|Geometric Mean
763243|NCT00667602|Secondary|Human Serum Bactericidal Activity Geometric Mean Titers After One Dose of MenACWY-CRM197 and MenC Against N.Meningitidis Serogroup C|Immunogenicity of one dose of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was assessed with geometric mean titer (GMT) of serum bactericidal assay with human complement (hSBA) against N. meningitidis serogroup C.|1 month postvaccination|Analysis was done on PP set.||Titers||95% Confidence Interval|Mean
763284|NCT00667992|Secondary|Rescue Medication Morning|The average of means for inhalations of rescue medication in the morning is presented.|2 weeks|Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler).||Number of inhalations||95% Confidence Interval|Least Squares Mean
763244|NCT00667602|Secondary|Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, W, Y|"Immunogenicity for one dose of MenACWY was assessed as percentages of subjects with serum bactericidal titer with human complement (hSBA) ≥ 1:8 and titer ≥ 1:4 by serogroups A, W, Y.
Serogroup C is not shown here as it is shown in other outcome measures."|1 month postvaccination.|Analysis was done on PP set.||Percentages of subjects||95% Confidence Interval|Number
763245|NCT00667602|Secondary|Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, Y|"Immunogenicity of two doses of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month postvaccination was assessed and compared as percentages of subjects with serum bactericidal titer with human complement (hSBA) ≥ 1:8, ≥ 1:4 against N.meningitidis Serogroup C.
Immunogenicity of two doses of MenACWY-CRM197 vaccine one month postvaccination was assessed as percentages of subjects with serum bactericidal titer with human complement (hSBA) ≥ 1:8, ≥ 1:4 against N.meningitidis Serogroup A, W, Y."|1 month postvaccination.|Analysis was done on PP set.||Percentages of subjects||95% Confidence Interval|Number
763246|NCT00667602|Secondary|Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:4 Against N.Meningitidis Serogroup C|Immunogenicity of one dose of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was assessed as percentage of subjects with serum bactericidal activity using human complement (hSBA) titers ≥ 1:4 against N. meningitidis serogroup C.|1 month postvaccination|Analysis was done on PP set.||Percentages of subjects||95% Confidence Interval|Number
763247|NCT00667602|Primary|Percentages of Subjects With Serum Bactericidal Titer ≥ 1:8 Against N.Meningitidis Serogroup C|Immunogenicity of one dose of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was measured using serum bactericidal assay with human complement (hSBA) titer ≥ 1:8 against N.meningitidis serogroup C.|1 month postvaccination|Analysis was done on the per-protocol (PP) set, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis.||Percentages of subjects||95% Confidence Interval|Number
763248|NCT00667693|Secondary|Secondary Outcomes Will Include Ease of Intubation (as Recorded by the Operator Immediately After Intubation on a 100 mm Visual Analog Scale [VAS]), the Number of Failures, the Number of Attempts Made, and the Amount of Bleeding That Occurred.||intraoperative, first post op morning||||||
763249|NCT00667693|Primary|Time to Intubation|time between sufficient muscle relaxant and placement of intubation tube|time between sufficient muscle relaxant and placement of intubation tube, up to 100 seconds|||seconds||Inter-Quartile Range|Median
763250|NCT00667732|Secondary|The Percentage of Per Protocol Participants Randomized and Treated in Each Arm Who Had Lab-measured A1c <6.5% at 24 Weeks of Treatment|efficacy criteria, 50% of per protocol participants reached A1c target of <6.5%|After 24 weeks of randomized treatment|Per protocol, all participants who completed treatment||percentage of participants|||Number
763251|NCT00667732|Primary|The Percentage of Intent to Treat Participants Randomized and Treated in Each Arm Who Had Lab-measured A1c <6.5% at 24 Weeks of Treatment||After 24 weeks of randomized treatment|Intent to treat. All participants randomized to treatment.||percentage of participants|||Number
763252|NCT00667745|Secondary|Suicidality||Measured over 6 months||||||
763253|NCT00667745|Secondary|Quality of Life as Measured by Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)||Measured over 6 months||||||
763254|NCT00667745|Secondary|Symptoms as Measured by the Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR) and the Young Mania Rating Scale (YMRS)||Measured over 6 months||||||
763255|NCT00667745|Primary|Number of Necessary Medication Adjustments|"Metric Definition (Necessary Clinical Adjustments (NCA)): Medication adjustments to reduce symptoms, optimize treatment response and functioning, or to address intolerable side effects. This was determined with the Medication Recommendation Tracking Form (MRTF), a novel method for capturing physician prescribing behavior and clinical decision making.
Range: whole numbers
Relevant time points: Weeks 2, 4, 6, 8, 12, 16, 20, and 24."|Measured over 6 months|||Adjustments||Standard Deviation|Mean
763256|NCT00667745|Primary|Overall Change in Bipolar Illness Severity as Measured by Clinical Global Impression for Bipolar Disorder Severity (CGI-BP-S) Score|"Scale: Clinical Global Impression for Bipolar Disorder Severity (CGI-BP-S) Construct: This scale holistically measures severity of a participant’s depression, mania, and overall illness.
Range: 0- not assessed, 1-normal (not at all ill), 2- borderline mentally ill, 3- mildly ill, 4- moderately ill, 5- markedly ill, 6- severely ill, 7- among the most extremely ill patients."|Relevant time points: baseline and week 24|||units on a scale||Standard Deviation|Mean
763257|NCT00667810|Secondary|Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SOB) Total Score at Week 78|The CDR-SOB is a global clinical staging instrument that sums 6 clinical ratings: 1) memory, 2) orientation, 3) judgment and problem solving, 4) involvement in community affairs, 5) home and hobbies, and 6) personal care based on the Clinical Dementia Rating Scale (CDR) interview. The CDR includes discussions with the participant and caregiver using a structured format. This scale had to be administered by a trained and certified global rater who did not have access to any information regarding adverse events experienced by the participant. CDR-SOB total score range is 0 (least impairment) to 18 (most impairment); a negative change from baseline indicates an improvement.|78 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.||Units on a scale||Standard Error|Least Squares Mean
763258|NCT00667810|Secondary|Change From Baseline in Dependence Scale Total Score at Week 78|The Dependence Scale (DS) is a 13-item, caregiver-rated instrument for determining the amount of support required by a participant with AD. The DS total score ranges from 0 to 15, with higher scores indicating more need for assistance. The DS was administered as an interview to the caregiver at scheduled study visits.|78 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.||Units on a scale||Standard Error|Least Squares Mean
763297|NCT00668265|Primary|Hamilton Anxiety Scale at 16 Weeks|Hamilton anxiety scale -- a well known quantitative measure for assessment of anxiety|16 weeks|Data was not analyzed: PI left the institution and the study was terminated|||||
763298|NCT00668317|Secondary|Improvement in Cough Symptoms Measured Using Leicester Cough Questionnaire||8 weeks||||||
763259|NCT00667810|Secondary|Percentage of Participants With Worsening From Baseline in DAD Total Score at Week 78 (US Analysis Plan)|Percentage of participants whose decrease (worsening) from baseline to Week 78 in DAD total score was <12.|78 weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.||Percentage of participants|||Number
763260|NCT00667810|Secondary|Percentage of Participants With Worsening From Baseline in DAD Total Score at Week 78 (European Union Analysis Plan)|Percentage of participants whose decrease (worsening) from baseline to Week 78 in DAD total score was at most 0, 6, 12 points.|78 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.||Percentage of participants||95% Confidence Interval|Number
763261|NCT00667810|Secondary|Percentage of Participants With Worsening From Baseline in ADAS-Cog/11 Total Score at Week 78 (US Analysis Plan)|Percentage of participants whose increase (worsening) from baseline to Week 78 in ADAS-Cog/11 total score is <7.|78 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.||Percentage of participants|||Number
763262|NCT00667810|Secondary|Percentage of Participants With Worsening From Baseline in ADAS-Cog/11 Total Score at Week 78 (European Union Analysis Plan)|Percentage of participants whose increase (worsening) in ADAS-Cog/11 total score from baseline to Week 78 was at most 0, 3, 7 points.|78 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.||Number of participants||95% Confidence Interval|Number
763263|NCT00667810|Secondary|Time to First Clinically Meaningful Deterioration on DAD Total Score (US Analysis Plan)|The time to first clinically meaningful deterioration was defined as the first time a participant experienced a decrease (worsening)from baseline in DAD total score of >=12.|78 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.||Days||95% Confidence Interval|Median
763264|NCT00667810|Secondary|Time to Median Placebo Deterioration on DAD Total Score|The time to first median placebo deterioration (for the EU) was defined as the first time a participant experienced a decrease (worsening) in DAD total score greater than or equal to the median worsening at Week 78 in the placebo group.|78 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.||Days||95% Confidence Interval|Median
763265|NCT00667810|Secondary|Time to First Clinically Meaningful Deterioration on ADAS-Cog/11 Total Score (United States [US] Analysis Plan)|The time to first clinically meaningful deterioration (for the US) was defined as the first time a participant experienced an increase (worsening) from baseline in ADAS-Cog/11 total score of >=7.|78 weeks|||Days||95% Confidence Interval|Median
763266|NCT00667810|Secondary|Time to Median Placebo Deterioration on ADAS-Cog/11 Total Score (European Union [EU] Analysis Plan)|The time to first median placebo deterioration (for the EU) was defined as the first time a subject experienced an increase from baseline (worsening) in ADAS Cog/11 total score greater than or equal to the median worsening observed at Week 78 in the placebo group. The Kaplan Meier estimate of the median time to first median placebo deterioration in ADAS Cog/11 total score was presented.|78 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.||Days||95% Confidence Interval|Median
763267|NCT00667810|Secondary|Divergence of Effect on the DAD Total Scores From Week 39 to Week 78|The MMRM estimated slope (based on linear contrasts)of the differences between bapineuzumab and placebo for the DAD total scores from Week 39 to Week 78 was presented.|39 weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.||Units/Years||Standard Error|Mean
763268|NCT00667810|Secondary|Divergence of Effect on the ADAS-Cog/11 Total Scores From Week 39 to Week 78|The MMRM estimated slope (based on linear contrasts) of the differences between bapineuzumab and placebo for the ADAS-Cog/11 total scores from Week 39 to Week 78 was presented.|39 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.||Units/Year||Standard Error|Mean
763269|NCT00667810|Secondary|The Change From Baseline in Brain Volume at Week 71|Brain volume was examined in a subset of participants by Magnetic Resonance Imaging Brain Boundary Shift Integral (MRI BBSI). Cerebral atrophy correlates closely with the gradual cognitive decline in AD and can be visualized by MRI. The BBSI technique involves positional matching of serial 3-dimensional MRI brain images, such that brain MRI-image volumes were first registered and then subtracted from each other. Atrophy rates would generally be expected to be lower if the underlying disease was attenuated by effective treatment.|71 Weeks|The vMRI population Included all randomized participants who enrolled in the vMRI substudies, received at least one infusion or portion of an infusion of study drug, and had a baseline and at least one postbaseline vMRI that passed quality control and was satisfactory for volumetric analysis.||mL/year||Standard Error|Least Squares Mean
763270|NCT00667810|Secondary|The Change From Baseline in Phospho-tau Levels in the Cerebrospinal Fluid (CSF) at Week 71.|Biomarkers CSF phospho-tau (p-tau) is an indicator of neuronal injury and neurodegeneration. An elevation in levels of tau, as well as specific p-tau species, is thought to be a marker for progressive cellular degeneration in AD. Accordingly, a reduction from baseline in levels of CSF tau in participants who received bapineuzumab compared with participants who received placebo may be indicative of a reduction in neuronal loss in participants treated with bapineuzumab.|71 Weeks|CSF population included all randomized participants who enrolled in the CSF substudies, received at least one infusion or portion of an infusion of study drug, and had a baseline and at least one postbaseline CSF measurement (CSF phospho-tau).||pg/mL||Standard Error|Least Squares Mean
763271|NCT00667810|Secondary|The Change From Baseline in Brain Amyloid Burden at Week 71.|Brain amyloid burden as imaged by 11C-Pittsburgh compound B (PiB) positron emission tomography (PET). The latter is a semiquantitative measure of the extent of fibrillar amyloid in the brain. PIB PET measurements were made in cortical regions found to have the highest burden of fibrillar amyloid at autopsy in participants diagnosed as having Alzheimer’s pathology, and also regions reported to have the highest average retention of PIB signal in previous PET studies enrolling participants with probable AD. This parameter reflects overall brain amyloid deposition as indexed by imaging. The change from baseline was measured as average standard uptake value ratio (SUVr) in prespecified regions of interest (ROI) assessed by PIB PET imaging in a subset of participants.|71 Weeks|PiB PET population included all randomized participants who enrolled in the PET substudies and who met the following criteria: a) received at least one infusion or portion of an infusion of study drug, b) had a baseline and at least one post baseline PiB PET assessment, and c) had an SUVr for the global cortical average (GCA) ROI≥1.35 at baseline.||SUVr||Standard Error|Least Squares Mean
763272|NCT00667810|Primary|The Change From Baseline in the Disability Assessment for Demential (DAD) Total Score at Week 78|The DAD measures instrumental and basic activities of daily living in participants with Alzheimer's Disease (AD). The DAD is administered to the participants’caregiver in the form of an interview. This scale had to be administered by a trained and certified global rater who did not have access to any information regarding adverse events experienced by the participant. This scale assesses a participants’ ability to initiate, plan, and perform activities related to hygiene, dressing, continence, eating, meal preparation, telephoning, going on an outing, finance and correspondence, medications, leisure, and housework. Each item can be scored as 1 = yes, 0 = no, non applicable = NA. A total score is obtained by adding the rating for each question and converting this total score out of 100. Higher scores indicate better function; a positive change from baseline indicates an improvement.|78 weeks|The Modified Intent-to-Treat (mITT) population included as all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.||Units on a scale||Standard Error|Least Squares Mean
763273|NCT00667810|Primary|The Change From Baseline in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)/11 Total Score at Week 78|The ADAS-Cog is a multi-item, objective measure of cognitive function. The scale evaluates memory, language, and praxis with items such as orientation, word recall, word recognition, object identification, comprehension, and the completion of simple tasks. Analysis of the ADAS-Cog for this study was based upon an 11 item score from the following items 1) word recall task, 2) naming objects and fingers, 3) following commands, 4) constructional praxis, 5) ideational praxis, 6) orientation, 7) word recognition, 8) remembering test instructions, 9) spoken language ability, 10) word finding difficulty in spontaneous speech, and 11) comprehension. This scale had to be administered by a trained and certified psychometric rater who did not have access to any information regarding adverse events experienced. The ADAS-Cog/11 ranged from 0 to 70 points, with higher scores indicating a greater degree of impairment. A negative change from baseline indicates a decrease in cognitive impairment.|78 weeks|The modified intent-to-treat (mITT) included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and Disability Assessment for Dementia (DAD) total score.||Units on a scale||Standard Error|Least Squares Mean
763274|NCT00667849|Other Pre-specified|Treatment Compliance|The percent of subjects who used the device greater than or equal to 18 minutes per day over 80% of the days in their treatment period.|Treatment period: Days from randomization to day of x-ray assessed healed or, if not heal, day of premature withdrawal/study termination or day 365 (end of study visit)|FAS with compliance data (subjects who returned the device)||percentage of compliant participants|||Number
763275|NCT00667849|Primary|Time (Days) to Radiographic Healing of Tibial Fractures|Days from randomization to day of x-ray assessed healed or, if not healed, day of premature withdrawal/study termination or day 365 (end of study visit)/ Kaplan-Meier|over 365 days|Full Analysis Set (FAS) is all subjects randomized with at least one post treatment set of adjudicated x-rays.||days||Inter-Quartile Range|Median
763276|NCT00667849|Primary|Change From Baseline in the SF-36 Physical Component Summary (PCS) Score of the Short Form-36 (SF-36)|Assessments at baseline and 6 post baseline time points/ mixed effects repeated measure single point estimate. Range= -100 worst, 0 best|Over 365 days|Full Analysis Set (FAS) is all subjects randomized with at least one post treatment set of adjudicated x-rays.||units on a scale||95% Confidence Interval|Least Squares Mean
763277|NCT00667875|Secondary|Percent Riboflavin Positive Urine Samples as a Measure of Medication Compliance|Riboflavin was added to each individual capsule of medication and measured as a proxy for compliance with the medication regime|16 weeks treatment trial|||Percent of riboflavin positive samples||Standard Deviation|Mean
763278|NCT00667875|Secondary|Pill Counts During Treatment|Compliance with medication as determined by pill counts|16-week|||Percent of pills taken||Standard Deviation|Mean
763279|NCT00667875|Primary|Percent Heavy Drinking Days|percent of total 112 day trial in which heavy drinking occurred (>=4 for females, >=5 male)|16 weeks|||percent of days||Standard Deviation|Mean
763280|NCT00667875|Primary|Drinks Per Drinking Day|Standard drinks per drinking day|16-week treatment period|||drinks per drinking day||Standard Deviation|Mean
763281|NCT00667992|Secondary|Peak Exploratory Flow (PEF) Morning|Peak Exploratory Flow (PEF) recorded daily in the morning|2 weeks|Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler).||Liters/minutes||95% Confidence Interval|Least Squares Mean
763282|NCT00667992|Secondary|Rescue Medication Total|The average of means for inhalations of rescue medication in morning and evening combined over a 24 hour period is presented.|2 weeks|Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler).||Number of inhalations/24 hours||95% Confidence Interval|Least Squares Mean
763283|NCT00667992|Secondary|Rescue Medication Evening|The average of means for inhalations of rescue medication in the evening is presented.|2 weeks|Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler).||Number of inhalations||95% Confidence Interval|Least Squares Mean
763285|NCT00667992|Secondary|Asthma Symptom Score Total|Asthma Symptom score recoded daily, Total. Scale: 0 - 3. 0 = None; no asthma symptoms. 1 = Mild symptoms; aware of asthma symptoms but easily tolerated. 2 = Moderate symptoms; asthma causing enough discomfort to cause problems with normal activities (or with sleep). 3 =Severe symptoms; unable to do normal activities. The average of means for values recorded daily is presented.|2 weeks|Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler).||Units on a scale||95% Confidence Interval|Least Squares Mean
763286|NCT00667992|Secondary|Asthma Symptom Score Evening|Asthma Symptom score recorded daily in the evening: Scale: 0-3. 0 = None; no asthma symptoms. 1 = Mild symptoms; aware of asthma symptoms but easily tolerated. 2 = Moderate symptoms; asthma causing enough discomfort to cause problems with normal activities (or with sleep). 3 =Severe symptoms; unable to do normal activities. The average of means for values recorded daily in the evening is presented.|2 weeks|Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler).||Units on a scale||95% Confidence Interval|Least Squares Mean
763287|NCT00667992|Secondary|Asthma Symptom Score Morning|Asthma Symptom score recorded daily in the morning: Scale: 0-3. 0 = None; no asthma symptoms. 1 = Mild symptoms; aware of asthma symptoms but easily tolerated. 2 = Moderate symptoms; asthma causing enough discomfort to cause problems with normal activities (or with sleep). 3 =Severe symptoms; unable to do normal activities. The average of means for values recorded daily in the morning is presented.|2 weeks|Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler).||Units on a scale||95% Confidence Interval|Least Squares Mean
763288|NCT00667992|Secondary|eNO (Exhaled Nitrogen Oxide)|eNO ratio of baseline|baseline and week 2|Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler).||Ratio||95% Confidence Interval|Geometric Mean
763289|NCT00667992|Secondary|FEF 25-75 (Forced Expiratory Flow 25-75)|FEF 25-75- Forced expiratory flow over the middle one half of the FVC. The results are expressed as the change from baseline|Baseline and week 2|Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler).||Liters/seconds||95% Confidence Interval|Least Squares Mean
763290|NCT00667992|Secondary|FEV1 (Forced Expiratory Volume in 1 Second)|FEV1 change from baseline|Baseline to week 2|Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler).||Liters||95% Confidence Interval|Least Squares Mean
763291|NCT00667992|Secondary|Peak Exploratory Flow (PEF)|Change in PEF at Week 2 from baseline, mean over all days in run-in and all dasy in treatment period, with baseline as covariate.|Baseline to week 2 recorded daily|Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler).||Liters/minutes||95% Confidence Interval|Least Squares Mean
763292|NCT00667992|Primary|PC 20 Methacholine (Provocative Concentration of Methacholine Causing 20 % Fall in FEV1(Forced Expiratory Volume)|"Provocative concentration of methacholine is that causing a 20% fall in FEV1. The methacholine challenge test entailed the patient inhaling from an aerosol containing doubling concentrations of methacholine over a period of 2 minutes until FEV1 had been reduced by 20%.
The ratio of Methacholine concentration measured at 2 weeks to that at Baseline."|Baseline and week 2|Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler).||Ratio||95% Confidence Interval|Geometric Mean
763293|NCT00668200|Secondary|Percentage of Newly Occurring Post-baseline Hypocalcemia Symptoms Based on Hypocalcemia Questionnaire at End of Study Visit 2 or Visit 3 (Safety Population)|The end of study is not a separate time point. It is the last post-baseline, for majority the end of study was visit 2. There were 2 patients who had the end of study at Visit 3. If calcium at visit 2 was abnormal it was measured again at visit 3.|End of study: Visit 2 (days 9 - 11 post-infusion) or visit 3 (day 30)|This Outcome Measure uses Safety population which includes 81 patients. During monitoring it was discovered that one patient signed the consent form from another Paget’s study; therefore, this patient was excluded from the ITT population but included in the safety. The ITT population was used for participant flow and baseline characteristics.||percentage of patients|||Number
763294|NCT00668200|Secondary|Change From Baseline in Serum Calcium (mmol/L) – Safety Population|Change from baseline = endpoint – baseline, at each time point, only participants with a value at baseline and that time point are included in the change from baseline column. In case of multiple assessments, for baseline visit the last measurement prior to the first dose was used in the analysis, and for Visits 2 and 3, the lowest serum calcium in the visit window was used.|Baseline, Visit 2 (days 9 - 11 post-infusion), visit 3 (day 30)|This Outcome Measure uses Safety population which includes 81 patients. During monitoring it was discovered that one patient signed the consent form from another Paget’s study; therefore, this patient was excluded from the ITT population but included in the safety. The ITT population was used for participant flow and baseline characteristics.||mmol/L||Standard Deviation|Mean
763295|NCT00668200|Primary|Percentage of Patients With Serum Calcium <2.07 mmol/L at 9-11 Days After Receiving Zoledronic Acid.|To be included in the analysis, patients were required to have a baseline serum calcium of at least 2.07 mmol/L and at least one serum calcium measurement 9-11 days post-infusion of zoledronic acid. In case of multiple assessments, for baseline visit the last measurement prior to the first dose was used in the analysis, and for Visits 2 and 3, the lowest serum calcium in the visit window was used. hypocalcemia was defined as treatment-emergent serum calcium <2.07 mmol/L at 9-11 days after the study drug infusion.|at Visit 2 (days 9 - 11 post-infusion), visit 3 (day 30)|Safety population which includes 81 patients was used. 75 of the 81 patients in the safety population met the criteria. 6 patients did not meet criteria and were excluded from the analysis: 1 patient had a low serum calcium at baseline, and the other 5 patients were missing serum calcium values either at baseline or post-baseline.||percentage of patients|||Number
763296|NCT00668265|Secondary|Beck Depression Inventory at 16 Weeks|To compare the effect of Quetiapine vs. placebo on symptoms of negative mood in patients with GAD and comorbid opiate abuse in remission.|16 weeks|Data were not analyzed. PI left institution, and did not respond to attempts top contact him.|||||
763299|NCT00668317|Primary|Change in Methacholine Sensitivity|"Concentration of methacholine (mg/ml) at which participants forced expired volume in 1 sec (FEV1) is reduced by 20% (the provocation concentration of methacholine causing a 20% fall in FEV1-PC20).
To measure if there is a significant difference in PC20 recorded at baseline to that recorded following 8 weeks treatment with omeprazole and ranitidine"|baseline and 8 weeks|All subjects recruited with efficacy data recorded after week T0 will be included in the ITT population for analysis. Assuming a within subject standard deviation(for change in PC20) of no more than 2.71 units, 30 subjects are sufficient to provide 80% power to detect a treatment difference of 1.8 units using a 5% two sided significance test||mg/ml||Standard Deviation|Mean
763300|NCT00668382|Primary|Number of Subjects With Greater Than Grade 3 or 4 Toxicity|Grade 3/4 Toxicity occurring in a participant within a month of intratumoral injection|1 month|Dose escalating Phase 1 scheme: three participants for each dose cohort. The second patient in the last (10 mg) dose cohort developed and adverse event (infection at injection site) and so three more participants were entered and analyzed at that dose||participants|||Number
763301|NCT00668395|Primary|Effect of CYP2B6 Genotype on Efavirenz Clearance|Efavirenz clearance is a measure of rate of elimination of the drug from the body. We used this measure to evaluate differences in rate of elimination of efavirenz at a single dose and after multiple dosing within three CYP2B6 genotypes (CYP2B6*1/*1, *1/*6 and CYP2B6*6/*6). Efavirenz clearance was measured in normal metabolizer of CYP2B6 (CYP2B6*1/*1 genotype), intermediate metabolizer (CYP2B6*1/*6) and slow metabolizer (CYP2B6*6/*6) at a single 600 mg oral dose of efavirenz and then after multiple dosing (autoinduction), i.e., the administration of efavirenz (600 mg/day) for 17 days. Single and multiple dose efavirenz clearance was measured and compared to determine the extent of autoinduction within this genotype group.|Efavirenz clearance at single dose and multiple dose stratified by CYP2B6 genotypes|||ml/h/kg||Standard Deviation|Mean
763302|NCT00668434|Secondary|Pain Numerical Rating Scale|Ordinal scale of average level of pain as perceived by the participant over the prior 3 days; measured on a 0-to-10 scale, with higher numbers indicating greater pain.|Baseline, Week 52 follow-up|||units on a scale||Standard Error|Mean
763303|NCT00668434|Secondary|Oswestry Disability Index, v2|The Oswestry Disability Index, v2 is a back-pain-specific measure of disability and functional status. It is measured on a 0-to-100 scale, with higher numbers indicating greater disability.|Baseline, Week 52 follow-up|||units on a scale||Standard Error|Mean
763304|NCT00668434|Secondary|Pain Numerical Rating Scale|Ordinal scale of average level of pain as perceived by the participant over the prior 3 days; measured on a 0-to-10 scale, with higher numbers indicating greater pain.|Baseline, Week 3 follow-up|||units on a scale||Standard Error|Mean
763305|NCT00668434|Primary|Oswestry Disability Index, v2|The Oswestry Disability Index, v2 is a back-pain-specific measure of disability and functional status. It is measured on a 0-to-100 scale, with higher numbers indicating greater disability.|Baseline, Week 3 follow-up|||units on a scale||Standard Error|Mean
763306|NCT00668525|Secondary|Change From Baseline in Hamiltion Rating Scale for Depression (HAM-D) at Week 8|The HAMD is a clinician-rated 24-item scale was used to rate the patient’s depressive state. It was also used to identify obsessive-compulsive, genital, and somatic symptoms, as well as diurnal variation in the presence of symptoms. Each item was scored on a 3, 4 or 5-point Likert scale. A score of 0 indicated the absence of symptoms, and a score of 2, 3 or 4 indicated symptoms of maximum severity. The total score range is 0 to 74 (higher score indicates a greater depressive state).|Change from baseline in HAM-D at week 8|The analysis was performed on the intent to treat population based on the LOCF approach using an ANCOVA model with treatment group and study center as factors and the baseline HAMD total score as a covariate.||Units on a scale||Standard Error|Mean
763307|NCT00668525|Primary|Change From Baseline in Total Montgomery Asberg Depression Rating Scale (MADRS) at 8 Weeks.|The MADRS is a 10-item clinician-rated scale that was used to assess depressive symptomatology over the patient's prior week. Patients were rated on 10 items designed to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest. Each item was scored on a 7-point Likert scale; a score of 0 indicated the absence of symptoms, and a score of 6 indicated symptoms of maximum severity. The total score range is 0 to 60 (higher score indicates a greater severity of symptoms).|Change from baseline in MADRS total score at week 8|The analysis was performed on the intent to treat population based on the LOCF approach using an ANCOVA model with treatment group and study center as factors and the baseline MADRS total score as a covariate.||Units on a scale||Standard Error|Mean
763308|NCT00668564|Secondary|Overall Survival|Number of patients alive at timepoints.|Day 100, 1 Year, 3 Years|Year 3 survival endpoint was not done due to study being terminated prematurely.||Participants|||Number
763309|NCT00668564|Primary|Number of Patients Achieving Engraftment|Rate of successful engraftment - patients who achieved and sustained donor engraftment; donor chimerism by day 100 of at least 90% after undergoing hematopoietic stem cell transplantation.|Day 100|||Participants|||Number
763310|NCT00668733|Primary|Number of Participants With Recurrence of AK Lesions|The primary efficacy variable in this study was the absence of AK lesions(sustained clearance rate) in the previously treated area.|Up to one year|Efficacy analyses were conducted on the evaluable subject population defined as all subjects who were eligible and enrolled in the follow-up study. All results were summarized overall and by original Phase 3 randomized treatment regimen and dose group. Actinic keratosis recurrence was categorized by presence or absence only.||participants|||Number
763311|NCT00668746|Secondary|Micocycline-Resistance From Saliva Sample|Percentage of Subjects Showing Micocycline-Resistance for each Species from Saliva Sample DNA Method: Saliva Sample Intent-to-treat Subjects|Baseline, Day 30 and Day 180|ITT||Percentage of Subjects|||Number
763312|NCT00668746|Secondary|Micocycline-Resistance From Plaque Samples|Percentage of Subjects showing Micocycline-Resistance for each Species from Plaque Samples DNA Method: Plaque Sample Intent-to-Treat Subjects - we report average of percentage for 4 plaque samples|Baseline, Day 30 and Day 180|ITT||Percentage of Subjects|||Number
763313|NCT00668746|Primary|Change in Percent of Minocycline-Resistant Bacteria Using Bacterial Culture|Percentage Change from Baseline is calculated as post-baseline percent minus baseline percent.|from Baseline to Day 30 and Day 180|intention to treat (ITT)||Percentage Change||Standard Deviation|Mean
763314|NCT00668785|Secondary|Percentage of Patients That Maintain Pre-PRP Visual Acuity at the 3 Month Time Point||March 2010||||||
763316|NCT00668785|Primary|Mean Change From Pre-PRP Best Corrected Visual Acuity (BCVA) at 3 Months as Expressed as an Early Treatment Diabetic Retinopathy Study (ETDRS) Score (Number of Letters Correctly Read.)|No outcome measures were obtained for this study. Study was terminated by Investigator/Sponsor due to low enrollment. The data was not formally analyzed but reviewed only on a case study basis.|March 2010||||||
763317|NCT00668863|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Grade 3 or Higher Adverse Events According to Common Terminology Criteria (CTCAE).|Any untoward medical occurrence in a patient who received study drug was considered an adverse event (AE), without regard to possibility of causal relationship. Treatment-emergent adverse events (TEAE): those which occurred or worsened after baseline. An adverse event resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a serious adverse event (SAE): death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Up to 11 cycles (1 cycle = 6 weeks)|Safety analysis set was defined as the same population as the Full Analysis Set.||Participants|||Number
763318|NCT00668863|Secondary|Plasma Concentration at Steady State (Css) of 5-FU|Concentration at 22 hour post start of 5-FU infusion were to be used as Css if 5-FU concentrations suggested steady state at 22 hours time point.|Cycle 1 Day 15|Analysis set was consisted of participants who provided an evaluable sample. Planned number of participants for pharmacokinetic analysis was 6.||ng/mL||Standard Deviation|Mean
763319|NCT00668863|Secondary|Volume of Distribution at Steady State (Vss) of Irinotecan|Vss was calculated using following equation: CL x mean residence time (MRT), where MRT = the area under the first moment curve from zero time to infinity (AUMC 0-∞)/AUC 0-∞− (infusion time/2), AUMC 0-∞ = the area under the first moment curve from zero time to time t (AUMC t)+ ((t x Ct*)/ kel) + (Ct* / kel^2), AUMC t is calculated using the linear trapezoidal method.|Cycle 1 Day 15|Analysis set was consisted of participants who provided an evaluable sample. Planned number of participants for pharmacokinetic analysis was 6.||L||Standard Deviation|Mean
763320|NCT00668863|Secondary|Clearance of Irinotecan|CL is calculated as dose divided by AUC 0-∞|Cycle 1 Day 15|Analysis set was consisted of participants who provided an evaluable sample. Planned number of participants for pharmacokinetic analysis was 6.||L/hour||Standard Deviation|Mean
763321|NCT00668863|Secondary|Terminal Phase Elimination Half-life (t1/2) of Irinotecan|Terminal phase half-life of irinotecan was calculated as ln 2/ kel.|Cycle 1 Day 15|Analysis set was consisted of participants who provided an evaluable sample. Planned number of participants for pharmacokinetic analysis was 6.||hours||Standard Deviation|Mean
763322|NCT00668863|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Measurable Concentration (AUC Last) and Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity (AUC ∞) of Irinotecan|"AUC last of irinotecan and its metabolite SN-38 were calculated using the Linear/Log trapezoidal method.
AUC∞ of irinotecan was calculated using following equation; AUC last+(C*t/kel), where Ct* is the estimated concentration at the time of the last quantifiable concentration, kel is terminal phase rate constant that is estimated as the absolute value of the slope of a linear regression during the terminal phase of the natural-logarithm (ln) transformed concentration-time profile."|Cycle 1 Day 15|Analysis set was consisted of participants who provided an evaluable sample. Planned number of participants for pharmacokinetic analysis was 6.||ng.h/mL||Standard Deviation|Mean
763323|NCT00668863|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Irinotecan||Cycle 1 Day 15|Analysis set was consisted of participants who provided an evaluable sample. Planned number of participants for pharmacokinetic analysis was 6.||hours||Full Range|Mean
763324|NCT00668863|Secondary|Maximum Observed Plasma Concentration (Cmax) of Irinotecan|Plasma samples were assessed at prior to initiation of irinotecan (and l-leucovorin) infusion, 1, 2 (predose for 5-FU bolus), 4, 8, and 24 hours after initiation of irinotecan infusion, and Cmax of irinotecan and its metabolite SN-38 were determined.|Cycle 1 Day 15|Analysis set was consisted of participants who provided an evaluable sample. Planned number of participants for pharmacokinetic analysis was 6.||ng/mL||Standard Deviation|Mean
763325|NCT00668863|Secondary|Apparent Oral Clearance (CL/F) of Sunitinib|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Cycle 1 Day 15|Analysis set was consisted of participants who provided an evaluable sample. Planned number of participants for pharmacokinetic analysis was 6.||L/hour||Standard Deviation|Mean
763326|NCT00668863|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hours Postdose (AUC 0-24) of Sunitinib|AUC 0-24 was determined using the Linear/Log trapezoidal method.|Cycle 1 Day 15|Analysis set was consisted of participants who provided an evaluable sample. Planned number of participants for pharmacokinetic analysis was 6.||ng.h/mL||Standard Deviation|Mean
763327|NCT00668863|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Sunitinib||Cycle 1 Day 15|Analysis set was consisted of participants who provided an evaluable sample. Planned number of participants for pharmacokinetic analysis was 6.||hours||Full Range|Mean
763328|NCT00668863|Secondary|Maximum Observed Plasma Concentration (Cmax) and Predose Concentration (Ctrough) of Sunitinib.|Plasma concentrations were assessed at predose, 2, 4, 6, 8, and 24 hours postdose and Cmax and Ctrough of sunitinib, its metabolite SU012662, and the total (sunitinib + SU0122662) were determined.|Cycle 1 Day 15|Analysis set was consisted of participants who provided an evaluable sample. Planned number of participants for pharmacokinetic analysis was 6.||ng/mL||Standard Deviation|Mean
763329|NCT00668863|Secondary|Duration of Response (DR)|DR is defined as the time from the first objective documentation of complete or partial response that is subsequently confirmed to the first documentation of disease progression or to death due to any cause, whichever occurs first. The definition of censorship is the same as PFS.|Up to 11 cycles (1 cycle = 6 weeks)|Analysis set was consisted of participants with a confirmed objective tumor response (CR or PR) among Full Analysis Set.||weeks||95% Confidence Interval|Median
763556|NCT00656656|Primary|Number of Patients Achieving a Short- and Long-term Remission of Pemphigus|Clinical remission was graded as partial remission on therapy, complete remission on therapy and complete remission off therapy, as described by Murell et al, J Am Acad Dermatol, 2008; 58:1043-6.|up to 43 months|||Participants|||Count of Participants
763330|NCT00668863|Secondary|Percentage of Participants Who Presented Objective Response: Objective Response Rate (ORR)|ORR is defined as the percentage of participants with best overall response of either a confirmed complete (CR) or partial response (PR) relative to the number of participants in FAS. Based on the response evaluation criteria in solid tumors (RECIST), CR is defined as the disappearance of all target lesions and PR is defined as a greater than or equal to 30% decrease in the sum of the longest dimensions of the target lesion.|Up to 11 cycles (1 cycle = 6 weeks)|Full Analysis Set was defined as all enrolled subjects who met the following criteria :1) Those who were diagnosed as having adenocarcinoma of the colon or rectum with documented locally advanced or metastatic disease and 2) those who received at least one dose of the study medication.||percentage of participants||95% Confidence Interval|Median
763331|NCT00668863|Secondary|Overall Survival (OS)|OS is defined as the time from the date of enrollment to the date of death due to any cause. OS data was censored on the day following the date of the last contact at which the patient is known to be alive.|Up to 11 cycles (1 cycle = 6 weeks)|Median OS was not calculable due to the large number of censored events (63 out of 71 were censored).||weeks||95% Confidence Interval|Median
763332|NCT00668863|Primary|Progression-Free Survival (PFS)|"PFS is defined as the time from the date of enrollment to the date of the first documentation of objective tumor progression or death due to any cause, whichever occurs first.
PFS data was censored on the day following the date of the last tumor assessment documenting absence of progressive disease for patients who 1) were given anti-tumor treatment other than the study treatment prior to observing objective tumor progression; 2) were removed from the study prior to documentation of objective tumor progression; and 3) were ongoing at the time of the analysis."|Up to 11 cycles (1 cycle = 6 weeks)|Full Analysis Set was defined as all enrolled subjects who met the following criteria :1) Those who were diagnosed as having adenocarcinoma of the colon or rectum with documented locally advanced or metastatic disease and 2) those who received at least one dose of the study medication.||weeks||95% Confidence Interval|Median
763333|NCT00668902|Primary|DOBmax (Maximum Value of DOB)|"The stable isotope [13C]pantoprazole is O-demethylated by cytochrome P450 CYP2C19 and that the 13CO2 produced and exhaled in breath as a result can serve as a safe, rapid, and noninvasive phenotyping marker of CYP2C19 activity in vivo.
Exhaled 13CO2 and 12CO2 were measured by IR spectroscopy before (baseline) and 2.5 to 120 min after dosing. Ratios of 13CO2/12CO2 after [13C]pantoprazole relative to 13CO2/12CO2 at baseline were expressed as change over baseline (DOB)."|baseline and 2.5, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, and 120 min after dosing|||ratio||Standard Deviation|Mean
763334|NCT00669019|Secondary|Progression-free Survival|Progression will be evaluated in this study using the RECIST criteria (the appearance of new lesions and/or at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study). Progression-free survival time was calculated as the time from treatment start to date of progression or death, whichever comes first.|Up to 2 years|||weeks||95% Confidence Interval|Median
763335|NCT00669019|Primary|Objective Response Rate|"Response will be evaluated in this study using the Response Evaluation Criteria in Solid Tumors (RECIST). A sum of the longest diameter (LD) for all target lesions will be calculated and reported as the baseline sum LD. The baseline sum LD will be used as reference by which to characterize the objective tumor response. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum LD; Objective response = CR + PR.
CT scans will be performed at baseline and every 4-8 weeks while on study."|Up to 25 weeks|||percentage of participants||95% Confidence Interval|Number
763336|NCT00669032|Secondary|Mean Daily Dose of Paracetamol Consumption|Mean daily dose of paracetamol consumption throughout the study, an average of 40 months|Throughout the study, an average of 40 months|The modified intention-to-treat population included all randomly assigned patients with at least one efficacy assessment after randomisation.||mg/day||Standard Deviation|Mean
763337|NCT00669032|Secondary|Percentage of Patients Who Consumed Rescue Medication for Osteoarthritis|Consumption of rescue medication (paracetamol/NSAID) for osteoarthritis throughout the study, an average of 40 months|Throughout the study, an average of 40 months|The modified intention-to-treat population included all randomly assigned patients with at least one efficacy assessment after randomisation.||percentage of patients|||Number
763338|NCT00669032|Secondary|Patient's Global Assessment Increase 20% (10mm) at the End of Follow-up|"Percentage of patients with an increase in the score of patient's global assessment by at least 20% and at least 10mm on the VAS at the end of follow-up.
The VAS is set between 0-100mm, higher values represent a better outcome."|40 months|The modified intention-to-treat population included all randomly assigned patients with at least one efficacy assessment after randomisation.||percentage of patients|||Number
763339|NCT00669032|Secondary|Function Improvement 20% (10mm) at the End of Follow-up|"Percentage of patients with a decrease in physical function score of at least 20% or at least 10mm on the VAS at the end of follow-up.
The VAS is set between 0-100mm, higher values represent a worse outcome."|40 months|The modified intention-to-treat population included all randomly assigned patients with at least one efficacy assessment after randomisation.||percentage of patients|||Number
763340|NCT00669032|Secondary|Overall Pain Reduction 20% (10mm) at the End of Follow-up|"Percentage of patients with a decrease in pain score of at least 20% or at least 10mm on the VAS at the end of follow-up.
The VAS is set between 0-100mm, higher values represent a worse outcome."|40 months|The modified intention-to-treat population included all randomly assigned patients with at least one efficacy assessment after randomisation.||percentage of patients|||Number
763341|NCT00669032|Secondary|Pain or Function Scores Reduction 50% (20mm) at the End of Follow-up|"Percentage of patients with a decrease in pain or physical function score of at least 50% and at least 20mm on the VAS at the end of follow-up.
The VAS is set between 0-100mm, higher values represent a worse outcome."|40 months|The modified intention-to-treat population included all randomly assigned patients with at least one efficacy assessment after randomisation.||percentage of patients|||Number
763350|NCT00669071|Secondary|Number of Participants Showing Success or Failure in Improvement of Melasma at Week 6 Using the Subject's Evaluation of Improvement|Number of participants showing success or failure in improvement of melasma at Week 6 using the Subject's evaluation of improvement (0 = Worse, 1 = No change, 2 = Improved, 3 = Much improved, 4 = Excellent Improvement) with Improved, Much improved and Excellent Improvement defined as success and Worse or No change being defined as failure|Baseline to week 6|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)||participants|||Number
763342|NCT00669032|Secondary|Responders OARSI 2004 at 34 Months Follow-up Visit|"Percentage of subjects with a clinical response according to Osteaorthritis Research Society International (OARSI) 2004 criteria at 34 months follow-up visit (6 months after fourth cycle). Patients were classified as responders if the pain or physical function scores decreased at least 50% and at least 20mm on the Visual Analogue Scale (VAS), or if two of the following three findings were recorded: a decrease in pain score of at least 20% or at least 10mm on the VAS, a decrease in physical function score of at least 20% and at least 10mm on the VAS, or an increase in the score of the patient's global assessment by at least 20% and at least 10mm on the VAS.
The VAS is set between 0-100mm, higher values represent a worse outcome in all cases except for both patient and physician global assessments where higher values indicate a better outcome."|34 months (6 months after fourth cycle)|The modified intention-to-treat population included all randomly assigned patients with at least one efficacy assessment after randomisation.||percentage of responders|||Number
763343|NCT00669032|Secondary|Responders OARSI 2004 at 27 Months Follow-up Visit|"Percentage of subjects with a clinical response according to Osteaorthritis Research Society International (OARSI) 2004 criteria at 27 months follow-up visit (12 months after third cycle). Patients were classified as responders if the pain or physical function scores decreased at least 50% and at least 20mm on the Visual Analogue Scale (VAS), or if two of the following three findings were recorded: a decrease in pain score of at least 20% or at least 10mm on the VAS, a decrease in physical function score of at least 20% and at least 10mm on the VAS, or an increase in the score of the patient's global assessment by at least 20% and at least 10mm on the VAS.
The VAS is set between 0-100mm, higher values represent a worse outcome in all cases except for both patient and physician global assessments where higher values indicate a better outcome."|27 months (12 months after third cycle)|The modified intention-to-treat population included all randomly assigned patients with at least one efficacy assessment after randomisation.||percentage of responders|||Number
763344|NCT00669032|Secondary|Responders OARSI 2004 at 21 Months Follow-up Visit|"Percentage of subjects with a clinical response according to Osteaorthritis Research Society International (OARSI) 2004 criteria at 21 months follow-up visit (6 months after third cycle). Patients were classified as responders if the pain or physical function scores decreased at least 50% and at least 20mm on the Visual Analogue Scale (VAS), or if two of the following three findings were recorded: a decrease in pain score of at least 20% or at least 10mm on the VAS, a decrease in physical function score of at least 20% and at least 10mm on the VAS, or an increase in the score of the patient's global assessment by at least 20% and at least 10mm on the VAS.
The VAS is set between 0-100mm, higher values represent a worse outcome in all cases except for both patient and physician global assessments where higher values indicate a better outcome."|21 months (6 months after third cycle)|The modified intention-to-treat population included all randomly assigned patients with at least one efficacy assessment after randomisation.||percentage of responders|||Number
763345|NCT00669032|Secondary|Responders OARSI 2004 at 14 Months Follow-up Visit|"Percentage of subjects with a clinical response according to Osteaorthritis Research Society International (OARSI) 2004 criteria at 14 months follow-up visit (6 months after second cycle). Patients were classified as responders if the pain or physical function scores decreased at least 50% and at least 20mm on the Visual Analogue Scale (VAS), or if two of the following three findings were recorded: a decrease in pain score of at least 20% or at least 10mm on the VAS, a decrease in physical function score of at least 20% and at least 10mm on the VAS, or an increase in the score of the patient's global assessment by at least 20% and at least 10mm on the VAS.
The VAS is set between 0-100mm, higher values represent a worse outcome in all cases except for both patient and physician global assessments where higher values indicate a better outcome."|14 months (6 months after second cycle)|The modified intention-to-treat population included all randomly assigned patients with at least one efficacy assessment after randomisation.||percentage of responders|||Number
763346|NCT00669032|Secondary|Responders OARSI 2004 at 7 Months Follow-up Visit|"Percentage of subjects with a clinical response according to Osteaorthritis Research Society International (OARSI) 2004 criteria at 7 months follow-up visit (6 months after first cycle). Patients were classified as responders if the pain or physical function scores decreased at least 50% and at least 20mm on the Visual Analogue Scale (VAS), or if two of the following three findings were recorded: a decrease in pain score of at least 20% or at least 10mm on the VAS, a decrease in physical function score of at least 20% and at least 10mm on the VAS, or an increase in the score of the patient's global assessment by at least 20% and at least 10mm on the VAS.
The VAS is set between 0-100mm, higher values represent a worse outcome in all cases except for both patient and physician global assessments where higher values indicate a better outcome."|7 months (6 months after first cycle)|The modified intention-to-treat population included all randomly assigned patients with at least one efficacy assessment after randomisation.||percentage of responders|||Number
763347|NCT00669032|Primary|Responders OARSI 2004 at the End of Follow-up|"Percentage of subjects with a clinical response according to Osteaorthritis Research Society International (OARSI) 2004 criteria at the end of follow-up. Patients were classified as responders if the pain or physical function scores decreased at least 50% and at least 20mm on the Visual Analogue Scale (VAS), or if two of the following three findings were recorded: a decrease in pain score of at least 20% or at least 10mm on the VAS, a decrease in physical function score of at least 20% and at least 10mm on the VAS, or an increase in the score of the patient's global assessment by at least 20% and at least 10mm on the VAS.
The VAS is set between 0-100mm, higher values represent a worse outcome in all cases except for both patient and physician global assessments where higher values indicate a better outcome."|40 months|The modified intention-to-treat population included all randomly assigned patients with at least one efficacy assessment after randomisation.||percentage of responders|||Number
763348|NCT00669071|Secondary|Number of Participants With Tolerability Assessments Resulting in Adverse Events|Number of participants with Tolerability assessments (erythema, scaling, dryness, stinging/burning, edema, telangiectasis, darkening or melasma spots) resulting in adverse events|Baseline to week 10|Safety||participants|||Number
763349|NCT00669071|Secondary|Number of Participants Showing Success or Failure in Improvement of Melasma at Week 10 Using the Subject's Evaluation of Improvement|Number of participants showing success or failure in improvement of melasma at Week 10 using the Subject's evaluation of improvement (0 = Worse, 1 = No change, 2 = Improved, 3 = Much improved, 4 = Excellent Improvement) with Improved, Much improved and Excellent Improvement defined as success and Worse or No change being defined as failure|Baseline to week 10|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)||participants|||Number
763351|NCT00669071|Secondary|Number of Participants Showing Success or Failure in Improvement of Melasma at Week 10 Using the Investigator's Evaluation of Improvement|Number of participants showing success or failure in improvement of melasma at Week 10 using the Investigator's evaluation of improvement (0 = Worse, 1 = No change, 2 = Improved, 3 = Much improved, 4 = Excellent Improvement) with Improved, Much improved and Excellent Improvement defined as success and Worse or No change being defined as failure|Baseline to week 10|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)||participants|||Number
763352|NCT00669071|Secondary|Number of Participants Showing Success or Failure in Improvement of Melasma at Week 6 Using the Investigator's Evaluation of Improvement|Number of participants showing success or failure in improvement of melasma at Week 6 using the Investigator's evaluation of improvement (0 = Worse, 1 = No change, 2 = Improved, 3 = Much improved, 4 = Excellent Improvement) with Improved, Much improved and Excellent Improvement defined as success and Worse or No change being defined as failure|Baseline to week 6|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)||participants|||Number
763353|NCT00669071|Secondary|Degree of Pigmentation (Melanin) Using a Mexameter at Weeks 6 and 10|Degree of pigmentation (melanin) using a Mexameter to record units on a scale at Weeks 6 and 10; units on a scale is a number that represents the presence or absence of melanin in the skin on a scale from 0 - 999 units with 0 units representing no melanin and 999 units representing the maximum amount of melanin.|Baseline to Week 6 and Baseline to Week 10|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)||units on a scale||Standard Deviation|Mean
763354|NCT00669071|Secondary|Number of Participants Who Were a Success or Failure With Regards to Melasma Severity at Week 6 Using the Investigator's Global Assessment (IGA) of Melasma With Clear/Almost Clear Being Success and All Others Being Failure|Number of participants who were a success or failure with regards to melasma severity at Week 6 as evaluated using the Investigator's Global Assessment (IGA) of melasma (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe) with Clear / Almost Clear being success and all others being failure|Baseline to week 6|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)||participants|||Number
763355|NCT00669071|Primary|Number of Participants Who Were a Success or Failure With Regards to Melasma Severity at Week 10 as Evaluated Using the Investigator's Global Assessment (IGA) of Melasma|Number of participants who were a success or failure with regards to melasma severity at Week 10 as evaluated using the Investigator's Global Assessment (IGA) of melasma (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe) with Clear / Almost Clear being success and all others being failure|Baseline to week 10|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)||participants|||Number
763356|NCT00669110|Other Pre-specified|Number of Participants With Laboratory Test Results of Potential Clinical Importance (PCI)|Laboratory test results meeting the criteria for PCI categorized as bicarbonate increase or decrease from baseline of ≥4 millimoles per liter (mmol/L); hematocrit <0.32 or >0.50 (females) or <0.37 or >0.55 (males) liters per liter (L/L); high density lipoprotein (HDL) cholesterol (fasting or nonfasting / unknown) decrease >0.21 mmol/L and test value ≥1.16 mmol/L; triglycerides (fasting or nonfasting / unknown) ≥2.258 mmol/L or increase ≥1.13 mmol/L and test value ≥3.39 mmol/L; urine specific gravity <1.001 or >1.035; and positive urinalysis result for protein (albumin), hemoglobin, or ketones.|Baseline (Extension study) up to Week 26 (Extension study)|Safety population (Baseline=Extension study). N=number of participants with analyzable laboratory data. Participants may be represented in >1 category.||participants|||Number
763357|NCT00669110|Other Pre-specified|Number of Participants With Electrocardiogram (ECG) Results of Potential Clinical Importance (PCI): Heart Rate (Low)|PCI criteria for females: heart rate (bpm) ranges from <68 and >126 at age 6 to <63 and >121 at age 11; heart rate from <63 and >121 at age 12 to <54 and >110 at age 17; heart rate <50 and >104 at age 18. Criteria for males: heart rate ranges from < 68 and >126 at age 6 to <63 and >121 at age 11; heart rate <58 and >116 at age 12 up <50 and >104 at age 17; heart rate <45 and >99 at age 18. Heart rates meeting the criteria for PCI categorized as low (less than the lower limit specified for age).|Baseline (Extension study) up to Week 26 (Extension study)|Safety population (Baseline=Extension study). N=number of participants with analyzable ECG data.||participants|||Number
763358|NCT00669110|Other Pre-specified|Number of Participants With Electrocardiogram (ECG) Results of Potential Clinical Importance (PCI)|ECG results meeting the criteria for PCI categorized as PR interval ≥200 milliseconds (msec); QT interval ≥480msec; QRS interval ≥120 msec; corrected QT (QTc) ≥500 msec ); >450 msec for males and >470 msec for females or increase of ≥60 msec or ≥30 msec change from baseline QTcB=QT corrected using Bazett formula; QTcF=QT corrected using the Fridericia formula.|Baseline (Extension study) up to Week 26 (Extension study)|Safety population (Baseline=Extension study). N=number of participants with analyzable ECG data. Participants may be represented in >1 category.||participants|||Number
763359|NCT00669110|Other Pre-specified|Number of Participants With Vital Sign Results of Potential Clinical Importance (PCI): Pulse Rate|PCI criteria for females: supine pulse rate (beats per minute [bpm]) ranges from <68 or >126 at age 6 to pulse <63 or >121 at age 11; pulse from <63 or >121 at age 12 to <54 or >110 at age 17; pulse from <50 or >104 at age 18. Criteria for males: pulse ranges from <68 or >126 at age 6 to pulse <63 or >121 at age 11; pulse from <58 or >116 at age 12 to <50 or >104 at age 17; pulse from <45 or >99 at age 18. Vitals signs meeting criteria for PCI categorized as Low or as postural change in pulse (increase in pulse ≥20 bpm for last supine to first standing pulse [supine to standing]).|Baseline (Extension study) up to Week 26 (Extension study)|Safety population (Baseline=Extension study).||participants|||Number
763360|NCT00669110|Other Pre-specified|Number of Participants With Vital Sign Results of Potential Clinical Importance (PCI): Weight|Vitals signs meeting the PCI criteria for weight categorized according to an increase of ≥7 percent or a decrease of ≥3.5 percent in body weight.|Baseline (Extension study) up to Week 26 (Extension study)|Safety population (Baseline=Extension study).||participants|||Number
763361|NCT00669110|Other Pre-specified|Number of Participants With Vital Sign Results of Potential Clinical Importance (PCI): Blood Pressure (BP)|PCI criteria for females: systolic BP [SBP] ranges from >110 and diastolic BP [DBP] >73 (>110/73) at age 6 up to BP >124/81 at age 11; BP from >121/79 at age 12 up to BP >132/86 at age 17. Criteria for males: BP ranges from >112/73 at age 6 up to BP >123/82 at age 10; BP from >119/79 at age 11 up to BP >140/89 at age 17. Vitals signs meeting the criteria for PCI categorized as BP elevation for 3 consecutive visits or as postural change in BP (decrease in SBP ≥20 millimeters of mercury [mmHg] or in DBP ≥15 mmHg for the last supine to first standing BP [supine to standing]).|Baseline (Extension study) up to Week 26 (Extension study)|Safety population (Baseline=Extension study).||participants|||Number
763362|NCT00669110|Other Pre-specified|Change From Baseline in Number of Participants for Tanner Assessment at Week 26: Males|Tanner Children and Adolescent Pubertal Staging questionnaire used to document the stage of development of secondary sexual characteristics. Male pubertal development staged by size of the genitalia and development of pubic hair (test categories). Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size). Change categories: 0=no change in stage, 1=change of 1 stage, 2=change of 2 stages, 3=change of 3 stages, and 4=change of 4 stages. Participants may be represented in more than 1 test category.|Baseline (Extension study), Week 26 (Extension study)|Safety population (Baseline=Extension study); N=number of participants with evaluable data at observation. No participants had a change of 3 stages or change of 4 stages reported, therefore only changes for 0 stages through 2 stages are reported.||participants|||Number
763363|NCT00669110|Other Pre-specified|Change From Baseline in Number of Participants for Tanner Assessment at Week 26: Females|Tanner Children and Adolescent Pubertal Staging questionnaire used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size (test categories). Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size). Change categories: 0=no change in stage, 1=change of 1 stage, 2=change of 2 stages, 3=change of 3 stages, and 4=change of 4 stages. Participants may be represented in more than 1 test category.|Baseline (Extension study), Week 26 (Extension study)|Safety population (Baseline=Extension study); N=number of participants with evaluable data at observation. No participants had a change of 3 stages or change of 4 stages reported, therefore only changes for 0 stages through 2 stages are reported.||participants|||Number
763364|NCT00669110|Other Pre-specified|Percentage of Participants With a Response of Much Improved or Very Much Improved Based on the Clinical Global Impressions Scales - Improvement (CGI-I) Score|CGI-I: 7-point clinician rated scale ranging from 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, to 7=very much worse. Participant with response is defined as having a score of 1 (very much improved) or 2 (much improved).|Baseline (Core study NCT00619619), Extension study Outpatient Weeks 1, 2, 4, 6, 10, 14, 18, 22, 26, and >26 (up to Week 29)|ITT population; LOCF. CGI-I data for Inpatient Days 1 to 4 reported in Core study NCT00619619.||percentage of participants|||Number
763365|NCT00669110|Other Pre-specified|Percentage of Participants With a Categorical Clinical Global Impressions Scales - Improvement (CGI-I) Score|CGI-I: 7-point clinician rated scale ranging from 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, to 7=very much worse. Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Scores above 4 reflect worsening of illness state as compared to baseline.|Baseline (Core study NCT00619619), Extension study Outpatient Weeks 1, 2, 4, 6, 10, 14, 18, 22, 26, and >26 (up to Week 29)|ITT population; LOCF. No participants had a CGI-I score of 6 or 7 (much worse, very much worse), therefore only scores 1 through 5 (very much improved to minimally worse) are reported. CGI-I data for Inpatient Days 1 to 4 reported in Core study NCT00619619.||percentage of participants|||Number
763366|NCT00669110|Other Pre-specified|Percentage of Participants With a Categorical Clinical Global Impressions Scales - Severity (CGI-S) Score|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1=normal, not ill at all, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill patients. Higher scores reflect higher severity of current illness states.|Extension study Outpatient Weeks 1, 2, 4, 6, 10, 14, 18, 22, 26, and >26 (up to Week 29)|ITT population; LOCF. No participants had a CGI-S score of 5, 6 or 7 (markedly, severely, or extremely ill), therefore only scores 1 through 4 (normal to moderately ill) are reported.||percentage of participants|||Number
763367|NCT00669110|Other Pre-specified|Change From Baseline (Bsl) in Hamilton Rating Scale for Depression 17-item (HAM-D17) Total Score|HAM-D17 is a clinician-rated interview to measure presence of depressive symptoms in 17 areas (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Total score ranges from 0 to 52; higher scores reflect higher severity of current illness states.|Baseline (Extension study), Extension study Outpatient Weeks 1, 2, 4, 6, 10, 14, 18, 22, 26, and >26 (up to Week 29)|ITT population; LOCF.||scores on a scale||Standard Deviation|Mean
763368|NCT00669110|Other Pre-specified|Percentage of Participants With Remission (Total Score ≤28) Based on Children's Depression Rating Scale – Revised (CDRS-R)|CDRS-R total score: scale measures 17 depressive symptoms, of which 3 are rated 1 to 5 and 14 are rated 1 to 7 (1 = no symptom difficulties; 5 to 7 = severe clinically significant difficulties) for a total score range of 17 to 113. Lower total scores indicate lower intensity of symptoms. Remission defined as a CDRS-R total score ≤28 (coded value of 1).|Extension study Outpatient Weeks 1, 2, 4, 6, 10, 14, 18, 22, 26, and >26 (up to Week 29)|ITT population; LOCF.||percentage of participants|||Number
763369|NCT00669110|Other Pre-specified|Change From Baseline (Bsl) in Children's Depression Rating Scale – Revised (CDRS-R) Total Score at Final On-therapy Visit|CDRS-R total score: scale measures 17 depressive symptoms, of which 3 are rated 1 to 5 and 14 are rated 1 to 7 (1 = no symptom difficulties; 5 to 7 = severe clinically significant difficulties) for a total score range of 17 to 113. Lower total scores indicate lower intensity of symptoms.|Baseline (Extension study), Extension study Outpatient Weeks 26 and >Week 26 (up to Week 29 or early termination)|Intent to Treat population (ITT): all treatment assigned participants with a baseline primary efficacy evaluation, at least 1 dose of study treatment, and at least 1 primary efficacy evaluation after first dose in Extension study NCT00669110. Last observation carried forward (LOCF).||scores on a scale||Standard Deviation|Mean
763370|NCT00669110|Primary|Number of Participants for Columbia Suicide-Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories|C-SSRS is a participant rated questionnaire to assess suicidal ideation, suicidal behavior, actual attempts (yes or no responses), and intensity of ideation (rated 1=low severity to 5=high severity). Yes/No responses are mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) categories: Completed suicide, suicide attempt, preparatory acts toward imminent suicidal behavior, suicidal ideation, and self-injurious behavior, or no suicidal intent. A participant could have a yes or no response in more than one category.|Postbaseline (≥Day 1 in Core study NCT00619619) up to Week 26 (Extension study)|Safety population (Baseline=Core study) includes all treatment assigned participants with at least 1 dose of study treatment during Core study NCT00619619 and Extension study NCT00669110.||participants|||Number
763371|NCT00669110|Primary|Number of Participants With Adverse Events AEs) and Serious Adverse Events (SAEs)|AEs are any untoward, undesired, or unplanned event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study treatment. The event does not need to be causally related to the study treatment. SAEs are adverse events that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in persistent or significant disability or incapacity, result in cancer, or result in a congenital anomaly or birth defect.|Baseline (Extension study) up to Extension study Week 29 Follow up visit|Safety population (Baseline=Extension study) includes all treatment assigned participants with at least 1 dose of study treatment during Extension study NCT00669110.||participants|||Number
763372|NCT00669214|Secondary|Mean Change in Percentage of Whole Body (Including Scalp) BSA Affected by Psoriasis at 24 Weeks|"Mean change in percentage of whole body (including scalp) BSA affected by psoriasis at 24 weeks (Day 168) relative to baseline. BSA was assessed by percentage of sites affected per body segment (head, trunk, and limbs). Investigators were instructed to use the rule of palm to estimate lesional skin BSA (1% BSA = palm to first interphalangeal joint)."|Week 24|ITT population. N's reflect patients who received at least one dose of study drug in the open-label period.||Percentage of BSA||Standard Deviation|Mean
763373|NCT00669214|Secondary|Mean Change in Percentage of Whole Body (Including Scalp) Body Surface Area (BSA) Affected by Psoriasis at 12 Weeks|"Mean change in percentage of whole body (including scalp) BSA affected by psoriasis at 12 weeks (Day 84) relative to baseline. BSA was assessed by percentage of sites affected per body segment (head, trunk, and limbs). Investigators were instructed to use the rule of palm to estimate lesional skin BSA (1% BSA = palm to first interphalangeal joint)."|Week 12|ITT population. N's reflect patients who received at least one dose of study drug or placebo in the double-blind treatment period.||Pecentage of BSA||Standard Deviation|Mean
763374|NCT00669214|Secondary|Mean Change in VAS of Patient-reported Scalp Itch at 24 Weeks|Mean change in VAS of patient-reported scalp itch at 24 weeks (Day 168) relative to baseline. The Visual Analog Scale (VAS) of patient-reported scalp itch measured the severity of a patient’s scalp itch on a scale of 0 to 10, where 0 was “no itching,” 5 was “moderate itching,” and 10 was “severe itching.”|Week 24|ITT population. If VAS at Day 168 was missing for a patient who discontinued before the final scheduled dose, the patient was not included in the analysis. If VAS at Day 168 was missing for a patient who completed the Day 161 dose, the last available VAS was used for analysis.||Points on VAS||Standard Deviation|Mean
763375|NCT00669214|Secondary|Mean Change in a Visual Analog Scale (VAS) of Scalp Itch at 12 Weeks|Mean change in VAS of patient-reported scalp itch at 12 weeks (Day 84) relative to baseline. The Visual Analog Scale (VAS) of patient-reported scalp itch measured the severity of a patient’s scalp itch on a scale of 0 to 10, where 0 was “no itching,” 5 was “moderate itching,” and 10 was “severe itching.”|Week 12|ITT population. If VAS at Day 84 was missing for a patient who discontinued before the final scheduled dose, the patient was not included in the analysis. If VAS at Day 84 was missing for a patient who completed treatment, the last available VAS from the treatment period was used for analysis.||Points on VAS||Standard Deviation|Mean
763376|NCT00669214|Secondary|Mean Change in Scalpdex Score at 24 Weeks|Mean change in Scalpdex score at 24 weeks (Day 168) relative to baseline. The Scalpdex point scoring scale ranges from 1=NEVER, 2='RARELY', 3='SOMETIMES', 4='OFTEN' and 5='ALL THE TIME'.|Week 24|ITT population. If Scalpdex at Day 168 was missing for a patient who discontinued before the final scheduled dose, the patient was not included in the analysis. If Scalpdex at Day 168 was missing for a patient who completed the Day 161 dose, the last available Scalpdex was used for analysis.||Points on Scalpdex||Standard Deviation|Mean
763377|NCT00669214|Secondary|Mean Change in Scalpdex Score at 12 Weeks|Mean change in Scalpdex score at 12 weeks (Day 84) relative to baseline. The Scalpdex point scoring scale ranges from 1=NEVER, 2='RARELY', 3='SOMETIMES', 4='OFTEN' and 5='ALL THE TIME'.|The two time points for Mean Change in Scalpdex Score at 12 Weeks are Day 0 and Day 84|ITT population. If Scalpdex at Day 84 was missing for a patient who discontinued before the final scheduled dose, the patient was not included in the analysis. If Scalpdex at Day 84 was missing for a patient who completed treatment, the last available Scalpdex from the treatment period was used for analysis.||Points on Scalpdex||Standard Deviation|Mean
763378|NCT00669214|Secondary|Proportion of Patients Who Achieved a Whole Body (Including Scalp) PGA Rating of Clear (0), Almost Clear (1), or Mild (2) at 24 Weeks|Proportion of patients who achieved a whole body (including scalp) PGA rating of 0, 1, or 2 at 24 weeks (Day 168) For details on the PGA scale, refer to the Secondary Outcome Measure Description for 12 weeks.|Week 24|ITT population. If PGA rating at Day 168 was missing for a patient who discontinued before the final scheduled open-label dose, the patient was considered a treatment failure (nonresponder) for analysis. If PGA rating at Day 168 was missing for a patient who completed the Day 161 dose, the last available PGA rating was used for analysis.||Proportion of patients||95% Confidence Interval|Number
763379|NCT00669214|Secondary|Proportion of Patients Who Achieved a Whole Body (Including Scalp) Physician's Global Assessment (PGA) Rating of Clear (0), Almost Clear (1), or Mild (2) at 12 Weeks|"Proportion of patients who achieved a whole body (including scalp) PGA rating of 0, 1, or 2 at 12 weeks (Day 84)
Physician's Global Assessment (PGA) scale:
0: Clear. No signs of plaque psoriasis.
Almost clear. Just perceptible erythema and just perceptible scaling.
Mild disease. Light pink erythema with minimal scaling.
Moderate disease. Dull red, clearly distinguishable erythema with diffuse scaling, some thickening.
Severe disease. Deep/dark red erythema with clearly obvious and diffuse scaling and thickening."|Week 12|ITT population. If PGA rating at Day 84 was missing for a patient who discontinued before the final scheduled dose, the patient was considered a treatment failure (nonresponder) for analysis. If PGA rating at Day 84 was missing for a patient who completed treatment, the last available PGA rating from the treatment period was used for analysis.||Proportion of patients|||Number
763390|NCT00669240|Secondary|Number of Treatment Responders in Belgium at Week 12 and at Week 24|"Responders are participants who answered no to both of the following 2 questions on the Nicotine Use Inventory (NUI): 1) Has the subject smoked any cigarettes (even a puff) in the last 7 days? 2) Has the subject used any other tobacco products (for example, pipe, cigars, snuff, chew) in the last 7 days?"|Week 12 and Week 24|All-subjects population in Belgium||participants|||Number
763569|NCT00656799|Secondary|Number of Participants With Pregnancies at 30 Days Post-dose|Pregnancies reported by means of a Pregnancy Reporting Form, consist of pregnant female participants or pregnant female partners of male participants|Up to 30 days post -dose|AST consisting of all participants who received a dose of sugammadex||participants|||Number
763380|NCT00669214|Secondary|Proportion of Patients Who Achieved a ≥ 50% Decrease in PSSI Score at 24 Weeks|Proportion of patients who achieved a ≥ 50% decrease in PSSI score at 24 weeks (Day 168) relative to baseline. The PSSI assessed: 1) extent of scalp psoriasis (i.e., percentage of area involved), which was scored from 1 to 6, where 1 = <10% and 6 = 90-100%); and 2) clinical signs (erythema, induration, and desquamation), which were scored from 0 to 4, where 0 = Absent and 4 = Severest possible). The sum of the separate scores for erythema, induration, and desquamation was multiplied by the score for the involved area. The PSSI score range was therefore 0-72.|Week 24|ITT population. If PSSI at Day 168 was missing for a patient who discontinued before the final scheduled open-label dose, the patient was considered a treatment failure (nonresponder) for analysis. If PSSI at Day 168 was missing for a patient who completed the Day 161 dose, the last available PSSI was used for analysis.||Proportion of patients||95% Confidence Interval|Number
763381|NCT00669214|Secondary|Proportion of Patients Who Achieved a ≥ 50% Decrease in PSSI Score at 12 Weeks|Proportion of patients who achieved a ≥ 50% decrease in PSSI score at 12 weeks (Day 84) relative to baseline. The PSSI assessed: 1) extent of scalp psoriasis (i.e., percentage of area involved), which was scored from 1 to 6, where 1 = <10% and 6 = 90-100%); and 2) clinical signs (erythema, induration, and desquamation), which were scored from 0 to 4, where 0 = Absent and 4 = Severest possible). The sum of the separate scores for erythema, induration, and desquamation was multiplied by the score for the involved area. The PSSI score range was therefore 0-72.|Week 12|ITT population. If PSSI at Day 84 was missing for a patient who discontinued before the final scheduled dose, the patient was considered a treatment failure (nonresponder) for analysis. If PSSI at Day 84 was missing for a patient who completed treatment, the last available PSSI from the treatment period was used for analysis.||Proportion of patients|||Number
763382|NCT00669214|Secondary|Proportion of Patients Who Achieved a ≥ 75% Decrease in PSSI Score at 24 Weeks|Proportion of patients who achieved a ≥ 75% decrease in PSSI score at 24 weeks (Day 168) relative to baseline. The PSSI assessed: 1) extent of scalp psoriasis (i.e., percentage of area involved), which was scored from 1 to 6, where 1 = <10% and 6 = 90-100%); and 2) clinical signs (erythema, induration, and desquamation), which were scored from 0 to 4, where 0 = Absent and 4 = Severest possible). The sum of the separate scores for erythema, induration, and desquamation was multiplied by the score for the involved area. The PSSI score range was therefore 0-72.|Week 24|ITT population. If PSSI at Day 168 was missing for a patient who discontinued before the final scheduled open-label dose, the patient was considered a treatment failure (nonresponder) for analysis. If PSSI at Day 168 was missing for a patient who completed the Day 161 dose, the last available PSSI was used for analysis.||Proportion of patients||95% Confidence Interval|Number
763383|NCT00669214|Primary|Proportion of Patients Who Achieved a ≥ 75% Decrease in Psoriasis Scalp Severity Index (PSSI) Score at 12 Weeks|Proportion of patients who achieved a ≥ 75% decrease in PSSI score at 12 weeks (Day 84) relative to baseline. The PSSI assessed: 1) extent of scalp psoriasis (i.e., percentage of area involved), which was scored from 1 to 6, where 1 = <10% and 6 = 90-100%); and 2) clinical signs (erythema, induration, and desquamation), which were scored from 0 to 4, where 0 = Absent and 4 = Severest possible). The sum of the separate scores for erythema, induration, and desquamation was multiplied by the score for the involved area. The PSSI score range was therefore 0-72.|Week 12|Intent-to-treat (ITT) population. If PSSI at Day 84 was missing for a patient who discontinued before the final scheduled dose, the patient was considered a treatment failure (nonresponder) for analysis. If PSSI at Day 84 was missing for a patient who completed treatment, the last available PSSI from the treatment period was used for analysis.||Proportion of patients|||Number
763384|NCT00669240|Secondary|Minnesota Nicotine Withdrawal Scale (MNWS) Subscale Scores for Participants in Belgium|Self-administered rating of intensity of nicotine withdrawal symptoms over past 24 hours; consists of 9 questions (urge to smoke, depressed mood, irritability, anxiety, difficulty concentrating, restlessness, increased appetite, difficulty going to sleep, difficulty staying asleep), each rated 0-4 (0=not at all, 1=slight, 2=moderate, 3=quite a bit, 4=extreme). Subscales: Negative affect domain (average of items 2-5); Insomnia domain (average of items 8 and 9); Urge to smoke (item 1); Restlessness (item 6); Increased appetite (item 7). Range 0-4 (higher score=greater intensity of symptoms)|Week 7 and Week 13 or 14 (Week 13/14)|All subjects population in Belgium; n=number of participants with analyzable data at observation.||scores on a scale||Standard Deviation|Mean
763385|NCT00669240|Secondary|Number of Participants Who Registered With LifeREWARDS On-line Behavioral Support Program|"Number of participants who answered 'yes' to the question Did you register with LifeREWARDS? (LifeREWARDS not available in Greece.)"|Week 12|All-subjects population; n=number of participants with analyzable data at observation (responded to the question at the last study visit).||participants|||Number
763386|NCT00669240|Secondary|Number of Participants Who Received Varenicline, by Duration of Treatment in Days||Baseline through Week 12 or Week 24|All-subjects population; Week 24 if a maintenance period was prescribed.||participants|||Number
763387|NCT00669240|Secondary|Number of Participants for Whom a Maintenance Period of Varenicline Was Prescribed at the End of Week 12|A maintenance period was an additional period of varenicline treatment that could be prescribed at Week 12 by the attending primary care physician in routine clinical practice|Week 12|All-subjects population||participants|||Number
763388|NCT00669240|Secondary|Number of Treatment Responders at Weekly Intervals From Week 3 Through Week 11|"Responders are participants who answered no to the following 2 questions: 1) Has the subject smoked any cigarettes (even a puff) in the last 7 days? 2) Has the subject used any other tobacco products (for example, pipe, cigars, snuff, chew) in the last 7 days? Assessment conducted at specified time points only when usual for the local clinical practice."|Weeks 3, 4, 5, 6, 7, 8, 9, 10, and 11|All-subjects population; n=number of participants in the All-subjects population with analyzable data (responders and non-responders) who were assessed for smoking cessation at the time point (per local clinical practice) .||participants|||Number
763389|NCT00669240|Secondary|Number of Participants With Smoking Cessation Assessments at Weekly Intervals From Week 3 Through Week 11|Assessment of smoking cessation (ie, not a single puff) in previous 7 days, at time points of routine review of patients per local clinical practice.|Weeks 3, 4, 5, 6, 7, 8, 9, 10, and 11|All-subjects population||participants|||Number
763391|NCT00669240|Secondary|Number of Treatment Responders at Week 12|"Responders are participants who answered no to both of the following 2 questions on the Nicotine Use Inventory (NUI): 1) Has the subject smoked any cigarettes (even a puff) in the last 7 days? 2) Has the subject used any other tobacco products (for example, pipe, cigars, snuff, chew) in the last 7 days?"|Week 12|All-subjects population||participants|||Number
763392|NCT00669240|Secondary|Number of Participants in Belgium Whose Smoking Status Was Known at the End of 12 Weeks and 24 Weeks|"Number of participants in Belgium who were determined to be a responder or a non-responder at the specified time point. (Responders are participants who answered no to both of the following 2 questions, and non-responders are participants who answered yes to at least 1 of the following 2 questions, on the Nicotine Use Inventory (NUI): 1) Has the subject smoked any cigarettes (even a puff) in the last 7 days? 2) Has the subject used any other tobacco products (for example, pipe, cigars, snuff, chew) in the last 7 days?)"|Week 12 and Week 24|All-subjects population in Belgium||participants|||Number
763393|NCT00669240|Secondary|Number of Participants Whose Smoking Status Was Known at the End of 12 Weeks|"Number of participants who were determined to be a responder or a non-responder at the specified time point. (Responders are participants who answered no to both of the following 2 questions, and non-responders are participants who answered yes to at least 1 of the following 2 questions, on the Nicotine Use Inventory (NUI): 1) Has the subject smoked any cigarettes (even a puff) in the last 7 days? 2) Has the subject used any other tobacco products (for example, pipe, cigars, snuff, chew) in the last 7 days?)"|Week 12|All-subjects population||participants|||Number
763394|NCT00669240|Primary|Number of Participants With Non-serious Adverse Events (AEs) or Serious Adverse Events (SAEs)|Non-serious AEs are any untoward medical occurrence in a clinical investigation (subject administered a product or medical device) observed or volunteered through 7 days after the last dose of study drug regardless of suspected causal relationship; SAEs are any untoward medical occurrence that results in death; is life-threatening; requires hospitalization or prolongation of hospitalization; results in disability or incapacity; congenital anomaly or birth defect observed or volunteered through 28 days after the last dose of study drug, regardless of suspected causal relationship.|Baseline through Week 12 or Week 24|Safety population, which is identical to the all-subjects population: all enrolled subjects who received at least 1 dose (including partial doses) of varenicline; Week 24 if a maintenance period was prescribed.||participants|||Number
763395|NCT00655356|Secondary|Evaluator Wrinkle Severity Assessment Responders|A responder was defined as a two point improvement on the blinded Evaluator's live assessment of each of the bilateral nasolabial fold wrinkles at rest using the 6-point ordinal Lemperle Wrinkle Severity Scale. On the Lemperle scale, a score of 5 (Very Deep Wrinkle) is worst and a score of 0 (No Visible Wrinkle) is best.|Baseline (prior to first treatment) compared to 3rd treatment visit, 2 and 4 months post final treatment|Analysis population was the ITT population, defined as all randomized subjects.||participants|||Number
763396|NCT00655356|Secondary|Subject Wrinkle Assessment Responders|A two point improvement on the Subject's live assessment of the wrinkles of the lower part of the face as compared to baseline on the Subject Wrinkle Assessment was considered a responder. The Subject Wrinkle Assessment scale was a five point scale with a score of -2 (Very Dissatisfied) being the worst and a score of +2 (Very Satisfied) being the best.|Baseline (prior to first treatment) compared to 3rd treatment visit, 2 and 4 months post final treatment|Analysis population was the ITT population, defined as all randomized subjects.||participants|||Number
763397|NCT00655356|Primary|Evaluator Wrinkle Severity Assessment Responders|A responder was defined as a two point improvement on the blinded Evaluator's live assessment of each of the bilateral nasolabial fold wrinkles at rest using the 6-point ordinal Lemperle Wrinkle Severity Scale. On the Lemperle scale, a score of 5 (Very Deep Wrinkle) is worst and a score of 0 (No Visible Wrinkle) is best.|Baseline (prior to first treatment) and 6 months after last treatment|Analysis population was the ITT population, defined as all randomized subjects.||participants|||Number
763398|NCT00655356|Primary|Subject Wrinkle Assessment Responders|A two point improvement on the Subject's live assessment of the wrinkles of the lower part of the face as compared to baseline on the Subject Wrinkle Assessment was considered a responder. The Subject Wrinkle Assessment scale was a five point scale with a score of -2 (Very Dissatisfied) being the worst and a score of +2 (Very Satisfied) being the best.|Baseline (prior to first treatment) and 6 months post final treatment|Analysis population was the ITT population, defined as all randomized subjects.||participants|||Number
763399|NCT00655486|Primary|Number of Subjects Who Withdrew From the Study Due to an Adverse Event (Maximum Study Duration 2 Years)|An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial including Pre-treatment, Run-In, Wash-Out, or Follow-Up Periods. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design).|2 years|All 97 subjects enrolled are in the Safety Set (SS) and are included in this analysis||subjects|||Number
763400|NCT00655486|Primary|Number of Subjects With at Least One Adverse Event During This Open-label Extension Study (Maximum Study Duration 2 Years)|An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial including Pre-treatment, Run-In, Wash-Out, or Follow-Up Periods. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design).|2 years|All 97 subjects enrolled are in the Safety Set (SS) and are included in this analysis||subjects|||Number
763401|NCT00655551|Secondary|Number of Subjects With at Least One Adverse Event With an Onset Within 4 Hours of Start of Infusion|An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial including Pre-treatment, Run-In, Wash-Out, or Follow-Up Periods. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design).|0-4 hours post start of the infusion|||subjects|||Number
763402|NCT00655551|Primary|Number of Subjects Who Withdrew From the Trial Due to an Adverse Event|An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial including Pre-treatment, Run-In, Wash-Out, or Follow-Up Periods. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design).|Entire trial period (up to 6 weeks), screening through safety follow-up period (2 weeks post last medication)|||subjects|||Number
767779|NCT00691054|Secondary|Median Overall Survival of Participants|Median overall survival rate of participants measured in months|12 months|||months||95% Confidence Interval|Median
763403|NCT00655551|Primary|Number of Subjects With at Least One Adverse Event During the Treatment Period (up to 7 Days)|An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial including Pre-treatment, Run-In, Wash-Out, or Follow-Up Periods. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design).|Treatment period (up to 7 days)|||subjects|||Number
763404|NCT00655564|Secondary|Safety of Alefacept Using CD4 Counts|Number of participants experiencing CD4 cell counts below 250/uL|52 weeks|||Participants|||Number
763405|NCT00655564|Primary|Efficacy|Efficacy of continuous use of alefacept as defined as the number of participants with a 75% reduction in Psoriasis Area and Severity Index (PASI) score from Baseline to week 52|52 weeks|||#Participants|||Number
763406|NCT00655629|Secondary|Patient Self Reported Improvement of Erectile Function Under Treatment Using a Categorical Rating Scale|Categorical Rating Scale is a binary rating scale with 2 response options which is 'yes/no'; percentage of participants with positive answers to the Global Assessment Question. Global Assessment Question (GAQ): 'Has the treatment you have been taking over the past for weeks improved your erection?' (yes/no)|up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data||percentage of participants|||Number
763407|NCT00655629|Secondary|Satisfaction With Medication at Week 12 or LOCF|"Treatment group difference in points on the Treatment Satisfaction Scale (TSS: 0-100 normalized, ordinal; Directionality: Higher scores indicate greater levels of (i) ease with erection, (ii) erectile functioning satisfaction, (iii) pleasure of sexual activity, (iv) satisfaction with orgasm, (v) confidence for completion, and (vi) satisfaction with medication.) domain Satisfaction with medication at LOCF expressed as the least square mean difference"|up to 12 weeks|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with LOCF values.||scores on a scale||Standard Deviation|Mean
763408|NCT00655629|Secondary|Change From Baseline in Confidence for Completion at 12 Weeks or LOCF|"Treatment group difference in points on the Treatment Satisfaction Scale (TSS: 0-100 normalized, ordinal; Directionality: Higher scores indicate greater levels of (i) ease with erection, (ii) erectile functioning satisfaction, (iii) pleasure of sexual activity, (iv) satisfaction with orgasm, (v) confidence for completion, and (vi) satisfaction with medication.) domain Confidence for completion from baseline to Week 12 or LOCF expressed as the least square mean difference"|from baseline up to 12 weeks|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data||scores on a scale||Standard Deviation|Mean
763409|NCT00655629|Secondary|Change From Baseline in Satisfaction With Orgasm at 12 Weeks or LOCF|"Treatment group difference in points on the Treatment Satisfaction Scale (TSS: 0-100 normalized, ordinal; Directionality: Higher scores indicate greater levels of (i) ease with erection, (ii) erectile functioning satisfaction, (iii) pleasure of sexual activity, (iv) satisfaction with orgasm, (v) confidence for completion, and (vi) satisfaction with medication.) domain Satisfaction with orgasm from baseline to Week 12 or LOCF expressed as the least square mean difference"|from baseline up to 12 weeks|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data||scores on a scale||Standard Deviation|Mean
763410|NCT00655629|Secondary|Change From Baseline in Pleasure of Sexual Activity at 12 Weeks or LOCF|"Treatment group difference in points on the Treatment Satisfaction Scale (TSS: 0-100 normalized, ordinal; Directionality: Higher scores indicate greater levels of (i) ease with erection, (ii) erectile functioning satisfaction, (iii) pleasure of sexual activity, (iv) satisfaction with orgasm, (v) confidence for completion, and (vi) satisfaction with medication.) domain Pleasure of sexual activity from baseline to Week 12 or LOCF expressed as the least square mean difference"|from baseline up to 12 weeks|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data||scores on a scale||Standard Deviation|Mean
763411|NCT00655629|Secondary|Change From Baseline in Erectile Function Satisfaction at 12 Weeks or LOCF|"Treatment group difference in points on the Treatment Satisfaction Scale (TSS: 0-100 normalized, ordinal; Directionality: Higher scores indicate greater levels of (i) ease with erection, (ii) erectile functioning satisfaction, (iii) pleasure of sexual activity, (iv) satisfaction with orgasm, (v) confidence for completion, and (vi) satisfaction with medication.) domain Erectile function satisfaction from baseline to Week 12 or LOCF expressed as the least square mean difference"|from baseline up to 12 weeks|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data||scores on a scale||Standard Deviation|Mean
763412|NCT00655629|Secondary|Change From Baseline in Ease With Erection at 12 Weeks or LOCF|"Treatment group difference in points on the Treatment Satisfaction Scale (TSS: 0-100 normalized, ordinal; Directionality: Higher scores indicate greater levels of (i) ease with erection, (ii) erectile functioning satisfaction, (iii) pleasure of sexual activity, (iv) satisfaction with orgasm, (v) confidence for completion, and (vi) satisfaction with medication.) domain Ease with Erection from baseline to Week 12 or LOCF expressed as the least square mean difference."|from baseline up to 12 weeks|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data||scores on a scale||Standard Deviation|Mean
763413|NCT00655629|Secondary|Number of Sexual Attempts Till First Successful Attempt||up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data||Sexual Attempts||Standard Deviation|Mean
763414|NCT00655629|Secondary|Change in Percentage From Baseline in Ability to Ejaculate at 12 Weeks|SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to have successful ejaculations.|from baseline up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data||percentage of ejaculation successes||Standard Deviation|Mean
763688|NCT00670540|Primary|Percentage of Participants Who Developed a New or Recurrence of Venous Thromboembolism (VTE)|new VTE which can occur during follow up for no VTE patients at inclusion. Or VTE recurrence for VTE patients at inclusion.|at 3 years|||percentage of participants||95% Confidence Interval|Number
763415|NCT00655629|Secondary|Change in Percentage From Baseline in Overall Satisfaction at 12 Weeks|SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to overall satisfactory attempts.|from baseline up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data||percentage of satisfactory attempts||Standard Deviation|Mean
763416|NCT00655629|Secondary|Change in Percentage From Baseline in Satisfaction With the Hardness of Erection at 12 Weeks|SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to get satisfactory hardness of erections.|from baseline up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data||percentage of satisfactory erections||Standard Deviation|Mean
763417|NCT00655629|Secondary|Change in Percentage From Baseline in Ability to Obtain an Erection at 12 Weeks|SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to obtain successful erections.|from baseline up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data||percentage of successful erections||Standard Deviation|Mean
763418|NCT00655629|Secondary|"Percentage of Subjects Achieving Back to Normal Erectile Function"|Responders: percentage of subjects achieving an IIEF-EF score > 25. The primary variable was the treatment group difference from baseline to Week 12 or Last observation carried forward (LOCF) of the least square mean difference in the IIEF-EF domain score (1-30 ordinal points, specifying the severity of erectile dysfunction: <=10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; >25 'no ED').|up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data||percentage of subjects|||Number
763419|NCT00655629|Primary|Change From Baseline in Success of Erection Maintenance at 12 Weeks|SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to maintain an erection after penetration.|from baseline up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data||percentage of successful maintenance||Standard Deviation|Mean
763420|NCT00655629|Primary|Change in Percentage From Baseline in Success of Penetration (SEP2) at 12 Weeks|SEP (Sexual Encounter Profile) items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to penetrate the partner.|from baseline up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data||percentage of successful penetrations||Standard Deviation|Mean
763421|NCT00655629|Primary|Change From Baseline in International Index of Erectile Function (IIEF-EF Sub-Score) at 12 Weeks or Last Observation Carried Forward (LOCF)|The primary variable was the treatment group difference from baseline to Week 12 or LOCF of the least square mean difference in the IIEF-EF domain score (Range: 1-30 ordinal. Directionality: severity of erectile dysfunction: <=10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; >25 'no ED'.)|from baseline up to 12 weeks|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data||scores on a scale||Standard Deviation|Mean
763422|NCT00655642|Primary|Change in Visual Analog Scale (VAS) Score for Nausea. This Was Calculated by Subtracting the Patient's Reported Score on the 30 Minute VAS From the Patient's Reported VAS Score on Their Baseline VAS.|"Participants independently rated their nausea severity on separate scales at the baseline and 30-minute evaluations to prevent the baseline VAS score from influencing the 30-minute mark. The VAS had the words Least Severe on the left and Most Severe on the right. The possible values range from 0 to 100mm with 0 at the Least Severe extreme and 100 at the Most Severe extreme. Investigators instructed the participant to draw a single vertical line through the point on the 100mm scale that corresponded to their nausea severity at the times of measurement (Baseline and 30 minutes)."|Baseline and 30 minute assessments|Analysis was performed on all patients who received one of the four treatments and completed the 30-minute VAS assessment. The trial was anticipated to require 18 months to achieve full accrual of patients (n=600). Given that we were at 30% information fraction at 17 months, an unplanned interim analysis was done.||millimeter||Inter-Quartile Range|Median
763423|NCT00655668|Secondary|Safety|Summary of Treatment-Emergent Events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE, Version 3: Following is the scale: Grade 1=Mild Adverse Event (AE), Grade 2=Moderate AE, Grade 3=Severe and Undesirable AE, Grade 4=Life-threatening or Disabling AE, and Grade 5=Death Related to AE.)|Up to 24 months|Safety Population (received at least one dose of study drug)||Participants|||Number
763424|NCT00655668|Secondary|Progression-Free Survival|Kaplan-Meier estimate of progression-free survival is defined as the start of study drug therapy to the first observation of disease progression or death due to any cause.|Up to 24 months|Intent-to-treat (ITT) Population||Months||95% Confidence Interval|Median
763425|NCT00655668|Secondary|Time-to-Progression|Kaplan-Meier estimate of time-to-progression is calculated as the time from the start of study drug therapy to the first documentation of progressive disease.|Up to 24 months|Due to early termination of study, data not analyzed. See outcome #4 for progression-free survival.|||||
763426|NCT00655668|Secondary|Duration of Response|Kaplan-Meier Estimate of duration of response calculated as the time from first computed tomography (CT) Scan or magnetic resonance imaging (MRI) that demonstrates at least a partial response to the first documentation of disease progression, including death due to Non-Hodgkin's Lymphoma.|Up to 24 months|Intent-to-treat (ITT) Population||Months||95% Confidence Interval|Median
763570|NCT00656799|Secondary|Number of Participants With Events Due to Possible Interaction of Sugammadex With Endo-/Exogenous Compounds Other Than Rocuronium|Evidence of AEs due to possible interaction of sugammadex with endogenous compounds or with exogenous compounds other than rocuronium|Day 1|AST consisting of all participants who received a dose of sugammadex||participants|||Number
763427|NCT00655668|Primary|Participants Categorized by Best Response as Determined by Investigator|"Participant response assessed by investigator; criteria by B. Cheson in Journal of Clinical Oncology, 1999 (see article for more detail):
Complete Response(CR): Complete disappearance of all detectable disease
Complete Response Unconfirmed(CRu): CR, but indeterminate bone marrow
Partial Response(PR): >50% decrease in six largest nodes/nodal masses
Stable Disease(SD): Less than PR, but not progressive disease
Relapsed Disease: In CR/CRu Patients, new lesions seen or increased by >=50% in previous sites
Progressive Disease(PD): >=50% increase from low in PR/Non-Responders"|Up to 24 months|Intent-to-treat (ITT) Population||Participants|||Number
763428|NCT00655733|Secondary|Safety||12 weeks||||||
763429|NCT00655733|Primary|The Efficacy of HMPL 004 Given at 1200 mg/Day, Assessed After 8 Weeks of Treatment With HMPL-004 in Inducing a Drop in the Subject's Crohn's Disease Activity Index (CDAI) by 100 Points.|For the Intention to Treat (ITT) population, the Worst Observation Carried Forward (WOCF) method, was used to measure the percentage of subjects in the HMPL 004 group as compared to the placebo group that achieved a clinical response of a CDAI reduction of 100 points at Week 8 as compared to the subject's entry level CDAI score.|8 weeks|The ITT population using the Worst Observation Carried Forward method.||% Participants|||Number
763430|NCT00655746|Primary|Dasatinib PK Parameters: Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF])|Pharmacokinetics is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. AUC(INF)=area under the plasma concentration-time curve from time zero extrapolated to infinite time|Day 1 and Day 6 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours post dose|||ng∙h/mL||Full Range|Geometric Mean
763431|NCT00655746|Primary|Dasatinib PK Parameter: Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-T])|area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC[0-T])for dasatinib|Day 1 and Day 6 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours post dose|||ng∙h/mL||Full Range|Geometric Mean
763432|NCT00655746|Primary|Dasatinib PK Parameter: Plasma Half-Life (T-HALF)|Pharmacokinetics is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. T-Half=plasma half-life|Day 1 and Day 6 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours post dose|||hours||Standard Deviation|Mean
763433|NCT00655746|Primary|Dasatinib PK Parameter Time of Maximum Observed Plasma Concentration(Tmax)|Pharmacokinetics is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. Tmax=time of maximum observed plasma concentration|Day 1 and Day 6 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours post dose|||hours||Full Range|Median
763434|NCT00655746|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations|An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a patient or clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.|At Informed Consent (within 21 days of Day 1) through Study Discharge (Day 7)|||Participants|||Number
763435|NCT00655746|Primary|Dasatinib Pharmacokinetic (PK) Parameter: Maximum Observed Plasma Concentration (Cmax)|Pharmacokinetics is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. Cmax=maximum observed plasma concentration of dasatinib|Day 1 and Day 6 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours post dose|||ng/mL||Full Range|Geometric Mean
763436|NCT00655811|Secondary|The Difference in Burning/Pain Sensation Ratings Between the Capsaicin or Placebo Application.|This secondary outcome is to see if subjects rated burning/pain differently between the topical capsaicin or placebo application. Participants will rate burning/pain intensity after topical capsaicin and placebo application. The burning/pain sensation intensity was recorded continuously on a 100-mm COVAS (0, no sensation to 100, maximum, strongest imaginable burning/pain sensation). The subjects were also asked to indicate whether they experienced any non-burning/-painful sensation.|1 day|||units on a scale||Standard Deviation|Mean
763437|NCT00655811|Secondary|Ethnic Differences on the Effects of Topical Capsaicin on Thermal Sensory Thermal Thresholds|A secondary endpoint is to see if topical capsaicin has an effect on warm and heat pain thresholds. Quantitative thermosensory testing was carried out using the Medoc TSA 2001 (Medoc Ltd). The probe baseline temperature was 32 °C and the contact area was 12 cm2. The probe warmed the skin surface at a linear rate of 0·4 °C per second, up to a cut-off of 50 °C. Thermal thresholds were measured in the following order: warmth sensation threshold was measured followed by heat pain detection threshold; each of them was determined four times by the ascending method of limits.|1 day|||Change in degrees Celsius||Standard Error|Mean
763438|NCT00655811|Primary|Ethnic Differences in Burning Pain Induced by Topical Capsaicin|The primary endpoint is to test the burning pain effect of topical capsaicin by using an continuous visual analog scale (CoVAS) intensity scale as an outcome measure. Participants will rate burning pain intensity after topical capsaicin application. The burning or pain sensation intensity was recorded continuously on a 100-mm COVAS (0, no sensation to 100, maximum, strongest imaginable pain sensation). The subjects were also asked to indicate whether they experienced any nonpainful sensation.|1 day|||units on a scale||Standard Error|Mean
763439|NCT00655824|Secondary|Number of Participants With Immunoglobulin A (IgA) <0.7 Grams Per Liter (g/L) or >4 g/L, Immunoglobulin M (IgM) <0.5 g/L or >3 g/L, and Immunoglobulin G (IgG) <6.5 g/L or >16 g/L at the Indicated Time Points|Blood samples of participants were collected for the measurement of IgA, IgG, and IgM.|BL of each TC and 8 wk PI, then every 4 wk until Wk 24, then every 8 wk until next TC, then every 12 wk follow-up (up to Study Wk 204). TCs were individualized based on clinical status and may not correlate to trial visits or study wk|FAS Population. Only participants with data available at particular time points were analyzed.||participants|||Number
763440|NCT00655824|Secondary|Number of Participants With a Positive or Negative Pregnancy Test Results.|Serum and urine pregnancy testing were performed for women of childbearing potential.|BL of each TC and 8 wk PI, then every 4 wk until Wk 24, then every 8 wk until next TC, then Weeks 12 and 24 of follow-up (up to Study Wk 156). TCs were individualized based on clinical status and may not correlate to trial visits or study wk|FAS Population||participants|||Number
763441|NCT00655824|Secondary|Number of Participants With Any Signs/Symptoms of Progressive Multifocal Leukoencephalopathy (PML)|"A neurological examination to detect any signs or symptoms consistent with a diagnosis of PML was conducted. Signs and symptoms of PML includ visual disturbances, ocular movements, ataxia, and changes in mental status such as disorientation or confusion. Participants with any signs/symptoms of PML on at least one visit (any visit) are included in the Yes category."|BL of each TC and 8 wk PI, then every 4 wk until Wk 24, then every 8 wk until next TC, then every 12 wk follow-up (up to Study Wk 204). TCs were individualized based on clinical status and may not correlate to trial visits or study wk|FAS Population||participants|||Number
763442|NCT00655824|Secondary|Number of Participants With Postive or Negative Results of Testing for Anti-HBc, Anti-HBs, and HBsAG|Blood samples were collected, and participants were evaluated for serologic evidence of Hepatitis B (HB) infection based on the results of testing for HBsAg, anti-HBc, and anti-HBs antibodies. Participants with positive results on at least one visit (any visit) are included in the indicated positive category. Positive test results denoted presence of the indicated parameters and Negative test results denoted absence of the indicated parameters.|BL of each TC and 8 wk PI, then every 4 wk until Wk 24, then every 8 wk until next TC, then every 24 wk follow-up (up to Study Wk 204). TCs were individualized based on clinical status and may not correlate to trial visits or study wk|FAS Population||participants|||Number
763443|NCT00655824|Secondary|Number of Participants With Postive or Negative Plasma/White Cell John Cunningham Virus (JCV) Polymerase Chain Reaction (PCR) Test Results|Blood samples were collected, and the plasma/white cell JCV PCR test was performed for qualitative analysis of plasma/white cell JCV DeoxyriboNucleic Acid (DNA). Participants with positive results on at least one visit (any visit) are included in the indicated positive category. Positive test results denoted presence of the indicated parameters and Negative test results denoted absence of the indicated parameters.|BL of each TC and 8 wk PI, then every 4 wk until Wk 24, then every 8 wk until next TC, then every 12 wk follow-up (up to Study Wk 204). TCs were individualized based on clinical status and may not correlate to trial visits or study wk|FAS Population||participants|||Number
763444|NCT00655824|Secondary|Time to CD19+ Cell Repopulation From the Time of the Last Ofatumumab Dose|Blood samples of participants were collected for the evaluation of the CD19+ B-cell subset. A participant was defined as repopulated at a visit if the CD19+ cell count was >=the lower limit of normal (LLN) or the Baseline value, whichever was lower. Time to the first repopulation relative to the last ofatumumab treatment was calculated as: (the date of the first sample where CD19+ was greater than or equal to the minimum of the LLN and the Baseline value minus the date of last dose of ofatumumab + 1) divided by 30.4375. Baseline was defined as the Baseline value from Study OFA112657.|BL of each TC and 8 wk PI, then every 4 wk until Wk 24, then every 8 wk until next TC, then every 12 wk follow-up (up to Study Wk 204). TCs were individualized based on clinical status and may not correlate to trial visits or study wk|FAS Population. Only participants with repopulated CD19+ cell counts were analyzed.||months||Standard Deviation|Mean
763445|NCT00655824|Secondary|Time to CD19+ Repopulation Relative to Baseline|Blood samples of participants were collected for the evaluation of the CD19+ B-cell subset. A participant was defined as repopulated at a visit if the CD19+ cell count was >=the lower limit of normal (LLN) or the Baseline value, whichever was lower. Time to the first repopulation relative to Baseline was calculated as: (the date of the first sample where CD19+ was greater than or equal to the minimum of the LLN and the Baseline value minus the Baseline date + 1) divided by 365.25. Baseline was defined as the Baseline value from Study OFA112657.|BL of each TC and 8 wk PI, then every 4 wk until Wk 24, then every 8 wk until next TC, then every 12 wk follow-up (up to Study Wk 204). TCs were individualized based on clinical status and may not correlate to trial visits or study wk|FAS Population. Only participants with repopulated CD19+ cell counts were analyzed.||years||Standard Deviation|Mean
763446|NCT00655824|Secondary|Number of Participants With Repopulated CD19+ Cell Counts at the Indicated Time Points|Blood samples of participants were collected for the evaluation of the CD19+ B-cell subset. The number of participants with repopulated CD19+ cell counts was determined. A participant was defined as repopulated at a visit if the cell count was >=the lower limit of normal (LLN) or the Baseline value, whichever was lower. Baseline was defined as the Baseline value from Study OFA112657.|BL of each TC and 8 wk PI, then every 4 wk until Wk 24, then every 8 wk until next TC, then every 12 wk follow-up (up to Study Wk 204). TCs were individualized based on clinical status and may not correlate to trial visits or study wk|FAS Population||participants|||Number
763447|NCT00655824|Secondary|Number of Participants With Grade 3 and 4 Neutropenia Events (NEs)|Blood samples of participants were collected for the evaluation of absolute neutrophil count. A Grade 3 NE was defined as absolute neutrophil count below the following values: absolute neutrophil count <1000-500/mm^3; <1.0-0.5 x 10^9/L. A Grade 4 NE was defined as absolute neutrophil count below the following values: absolute neutrophil count <500/mm3; <0.5 x 10^9/L. Blood samples of participants were collected for the evaluation of platelet count. Grade 3 thrombocytopenia was defined as platelet counts below the following values: platelet count <50000-25000/mm^3; <50.0-25.0 x 10^9/L. Grade 4 thrombocytopenia was defined as platelet counts below the following values: platelet count <25000/mm^3; <25.0 x 10^9/L.|BL of each TC and 8 wk PI, then every 4 wk until Wk 24, then every 8 wk until next TC, then every 12 wk follow-up (up to Study Wk 156). TCs were individualized based on clinical status and may not correlate to trial visits or study wk|FAS Population||participants|||Number
763448|NCT00655824|Secondary|Number of Participants With Normal and Abnormal Electrocardiogram Readings|Electrocardiograms of the participants were taken. The abnormal clinically significant (CS) and not clinically significant (NCS) reading, as determined by the Investigator, were recorded.|8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population. Only participants with data available at particular time points were analyzed.||participants|||Number
763449|NCT00655824|Secondary|Assessment of Lactic Dehydrogenase (LDH) and Creatine Phosphokinase (CPK)|Blood samples of participants were collected to assess LDH and CPK. Both tests are performed to evaluate the injury and damage to the body tissue, potentially from B-cell lysis.|BL of each TC and 8 wk PI, then every 4 wk until Wk 24, then every 8 wk until next TC, then Weeks 12 and 24 of follow-up (up to Study Wk 156). TCs were individualized based on clinical status and may not correlate to trial visits or study wk|FAS Population. Only participants with data available at particular time points were analyzed.||U/L||Standard Deviation|Mean
763670|NCT00670462|Secondary|Physical Activity, Energy Expenditure|change from baseline in energy expenditure at 18 months|18 months|||kcal/wk||Standard Error|Mean
763450|NCT00655824|Secondary|Assessment of Body Temperature (BT)|The BT of the participants was measured BI and post the first (A) and second (B) infusions (PI) of each cycle to assess the effect of ofatumumab on the BT. The BT of the participants was measured before BI and PI A and B during all 7 treatment courses. Timing for taking BT reading: TC1, 3 (infu A) more than 2 hours PI; TC1, 2 ,3, 4, 7 (infu B) 2 hours PI; TC2, 4, 5, 6, 7 (infu A) 2 hours PI; TC5, 6 (infu B) 1 hour PI.|BI and PI A and B for all TCs (8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course [up to 156 weeks, follow-up phase]). TCs were individualized based on clinical status and may not correlate to trial visits/wk|FAS Population. Only participants with data available at particular time points were analyzed.||Degrees celcius||Standard Deviation|Mean
763451|NCT00655824|Secondary|Assessment of Heart Rate (HR)|The HR of the participants was measured to assess the condition of the heart. HR was measured BI and post the first (A) and second (B) infusions during all 7 treatment courses. Timing for measuring HR: TC1, 3 (infu A) more than 2 hours PI; TC1, 2 ,3, 4, 7 (infu B) 2 hours PI; TC2, 4, 5, 6, 7 (infu A) 2 hours PI; TC5, 6 (infu B) 1 hour PI.|BI and PI A and B for all TCs (8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course [up to 156 weeks, follow-up phase]). TCs were individualized based on clinical status and may not correlate to trial visits/wk|FAS Population. Only participants with data available at particular time points were analyzed.||Beats per minute (bpm)||Standard Deviation|Mean
763452|NCT00655824|Secondary|Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|The blood pressure (BP) of the participants was measured before infusion (infu) (BI) and post the first (A) and second (B) infusions (PI) during all 7 treatment courses. Timing for taking BP readings: SBP (BP when the heart is contracting): TC1, 2, 3 (infu A) more than 2 hours PI; TC1, 2 ,3 (infu B) 2 hours PI; TC4, 5, 6, 7 (infu A) 2 hours PI; TC4, 7 (infu B) 2 hours PI; TC5, 6 (infu B) 1 hour PI. For DBP (BP when the heart is resting between beats): TC1, 3 (infu A) more than 2 hours PI; TC2, 4, 5, 6, 7 (infu A) 2 hours PI; TC1, 2, 3, 4, 7 (infu A) 2 hours PI; TC5, 6 (infu B) 1 hour PI.|BI and PI A and B for all TCs (8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course [up to 156 weeks, follow-up phase]). TCs were individualized based on clinical status and may not correlate to trial visits/wk|FAS Population. Only participants with data available at particular time points were analyzed.||Millimeters of mercury (mmHg)||Standard Deviation|Mean
763453|NCT00655824|Secondary|Assessment of Blood Urea Nitrogen (BUN)|The blood samples of participants were collected to assess the amount of nitrogen (in the form of urea) in the blood. BUN is evaluated to assess the renal function of the participants.|BL of each TC and 8 wk PI, then every 4 wk until Wk 24, then every 8 wk until next TC, then Weeks 12 and 24 of follow-up (up to Study Wk 156). TCs were individualized based on clinical status and may not correlate to trial visits or study wk|FAS Population. Only participants with data available at particular time points were analyzed.||millimoles per liter||Standard Deviation|Mean
763454|NCT00655824|Secondary|Assessment of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (AP), and Gamma Glutamyl-transferase (GGT)|Blood samples of participants were collected for the evaluation of ALT, AST, AP, and GGT. AST, ALT, AP, and GGT are evaluated to assess the condition of the liver.|BL of each TC and 8 wk PI, then every 4 wk until Wk 24, then every 8 wk until next TC, then Weeks 12 and 24 of follow-up (up to Study Wk 156). TCs were individualized based on clinical status and may not correlate to trial visits or study wk|FAS Population. Only participants with data available at particular time points were analyzed.||Units per liter (U/L)||Standard Deviation|Mean
763455|NCT00655824|Secondary|Assessment of Total Bilirubin (TB) and Creatinine|Blood samples of participants were collected to evaluate TB and creatinine levels. TB evaluation is performed to assess the condition of the liver, and possible hemolytic anemia, and the creatinine evaluation is performed to assess the renal condition (condition of the kidneys).|BL of each TC and 8 wk PI, then every 4 wk until Wk 24, then every 8 wk until next TC, then Weeks 12 and 24 of follow-up (up to Study Wk 156). TCs were individualized based on clinical status and may not correlate to trial visits or study wk|FAS Population. Only participants with data available at particular time points were analyzed.||Micromoles per liter (umol/L)||Standard Deviation|Mean
763456|NCT00655824|Secondary|Assessment of Total Protein (TP) and Albumin|Blood samples of participants were collected to evaluate TP and albumin. TP can vary depending on auto-immune diseases, and TP and albumin can vary depending on debilitating diseases.|BL of each TC and 8 wk PI, then every 4 wk until Wk 24, then every 8 wk until next TC, then Weeks 12 and 24 of follow-up (up to Study Wk 156). TCs were individualized based on clinical status and may not correlate to trial visits or study wk|FAS Population. Only participants with data available at particular time points were analyzed.||Grams/Liter (g/L)||Standard Deviation|Mean
763457|NCT00655824|Secondary|Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid|Blood samples of participants were collected for the evaluation of uric acid and electrolytes (sodium, potassium, chloride, and calcium), as increased levels may reflect B-cell lysis due to treatment with ofatumumab.|BL of each TC and 8 wk PI, then every 4 wk until Wk 24, then every 8 wk until next TC, then Weeks 12 and 24 of follow-up (up to Study Wk 156). TCs were individualized based on clinical status and may not correlate to trial visits or study wk|FAS Population. Only participants with data available at particular time points were analyzed.||Millimoles/liter (mmol/L)||Standard Deviation|Mean
763458|NCT00655824|Secondary|Number of Participants With Interleukin 6 (IL-6) >11.9 Picograms Per Milliliter|Blood samples of participants were collected for the evaluation of IL-6. IL-6 plays an important role in immune response and helps assess the disease condition.|Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population. Only participants with data available at particular time points were analyzed.||participants|||Number
763459|NCT00655824|Secondary|Number of Participants With B-Lymphocyte Stimulator (BLyS) >2.49 Micrograms Per Liter|Blood samples of participants were collected for the evaluation of BLyS. BLyS is a potent co-stimulator of B lymphocytes, and elevated levels of BLyS are observed in autoimmune diseases. It regulates the immunoglobin (antibody produced by B cells that is used by the immune system to identify bacteria and viruses in the body) secretion of normal B cells (type of cells in the blood).|Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population. Only participants with data available at particular time points were analyzed.||participants|||Number
763460|NCT00655824|Secondary|Number of Participants With Anti-cyclic Citrullinated Peptide Antibody (CCP) >6.9 International Units Per Liter|Blood samples of participants were collected for the evaluation of Anti-CCP. Anti-CCP plays an important role in immune response and helps assess the disease condition.|Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population. Only participants with data available at particular time points were analyzed.||participants|||Number
763461|NCT00655824|Secondary|Number of Participants With Rheumatoid Factor (RA Factor) >13 International Units Per Milliliter|Blood samples of participants were collected for the evaluation of RA factor. RA factor is an antibody found in the blood of participants with rheumatoid arthritis and is used for the diagnosis of rheumatoid arthritis.|Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population. Only participants with data available at particular time points were analyzed.||participants|||Number
763462|NCT00655824|Secondary|Ratio of CD 4+/CD8+|Blood samples of participants were collected for the evaluation of CD4+ and CD8+ cell counts and the ratio was calculated.|Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population. Only participants with data available at particular time points were analyzed.||Ratio of CD 4+/CD8+ cells||Standard Deviation|Mean
763463|NCT00655824|Secondary|CD19+, CD4+, CD3+, and CD8+ Cell Counts, Measured in mm^3|Blood samples of participants were collected for the evaluation of CD19+, CD4+, CD3+, and CD8+ cell counts. These cells are present on white blood cells and are used as markers to associate cells with immune functions. Only CD19+ cells were measured in the Follow-up Period.|BL of each TC and 8 wk PI, then every 4 wk until Wk 24, then every 8 wk until next TC, then every 12 wk follow-up (up to Study Wk 204). TCs were individualized based on clinical status and may not correlate to trial visits or study wk|FAS Population. Only participants with data available at particular time points were analyzed.||cells per millimeters cubed (mm^3)||Standard Deviation|Mean
763464|NCT00655824|Secondary|Percentage of Cluster of Differentiation (CD)19+, 4+, 3+, and 8+ B-cell Subsets in the Blood|Blood samples of participants were collected for the evaluation of CD19+, CD4+, CD3+, and CD8+ B-cell subsets. These biomarkers are associated with immune functions. Only CD19+ cells were measured in the Follow-up Period.|BL of each TC and 8 wk PI, then every 4 wk until Wk 24, then every 8 wk until next TC, then every 12 wk follow-up (up to Study Wk 204). TCs were individualized based on clinical status and may not correlate to trial visits or study wk|FAS Population. Only participants with data available at particular time points were analyzed.||Percentage of CD19+, 4+, 8+, and 3+ BCSs||Standard Deviation|Mean
763465|NCT00655824|Secondary|Whole Blood Transcriptional Profiles|Blood samples were collected for transcriptomic analysis of messenger ribonucleic acid (mRNA). The sponsor discontinued the IV administration development program for RA, and this study was terminated early; hence, this endpoint was not evaluated.|Baseline (BL) of each TC and 8 wk post infusion (PI), then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population|||||
763466|NCT00655824|Secondary|Number of Participants With HAHA Response|The host immune response was assessed based on Human Anti-Human Antibodies (HAHA). The serum samples of the participants were collected for the assessment of HAHA. The sponsor discontinued the IV administration development program for RA, and this study was terminated early; hence, this endpoint was not evaluated.|Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population|||||
763467|NCT00655824|Secondary|Number of Participants With the Indicated Pain Score|"The pain score was assessed using the VAS: a 10 cm scale ranging from no pain to severe pain; the distance marked by the participant from the no pain end is his joint pain score. The sponsor discontinued the IV administration development program for RA, and this study was terminated early; hence, this endpoint was not evaluated."|Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population|||||
763468|NCT00655824|Secondary|Number of Participants With the Indicated Global Disease Assessment Using the VAS|The participant and the physician independently used the VAS for overall assessment of the disease. VAS is used to measure the physician's subjective assessment of the participant's RA disease process at the time of the visit. The scale ranged from 0 (extremely well) to 10 (extremely poor). The sponsor discontinued the IV administration development program for RA, and this study was terminated early; hence, this endpoint was not evaluated.|Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population|||||
763469|NCT00655824|Secondary|Number of Participants in the Indicated Categories of the Health Assessment Questionnaire (HAQ)|The HAQ, a 20-question instrument, assesses the degree of difficulty a person has in accomplishing tasks in eight functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores). Responses in each area are scored from 0 (no difficulty) to 3 (inability to perform a task in that area). The index is calculated by adding all scores, then dividing this score by the total number of components answered. The sponsor discontinued the IV administration development program for RA, and this study was terminated early; hence, this endpoint was not evaluated.|Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population|||||
763489|NCT00655863|Secondary|Change From Baseline in Postprandial Proinsulin|The change in postprandial proinsulin collected at each week indicated relative to baseline.|Baseline, Week 4 and Week 16.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.||pmol/L||Standard Error|Least Squares Mean
763470|NCT00655824|Secondary|Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response|EULAR response is based on the DAS score. EULAR response criterion classifies participants as good or moderate responders and non-responders. Good response: DAS28 score <=3.2 and >1.2 improvement from Baseline (IfB) in DAS28 score, Moderate response: DAS28 score <=3.2 and between >0.6 and <=1.2 IfB; DAS28 score between >3.2 and <=5.1 and >1.2 IfB; DAS28 score between >3.2 and <=5.1 and between >0.6 and <=1.2 IfB; DAS28 score >5.1 and >1.2 IfB. The sponsor discontinued the IV administration development program for RA, and this study was terminated early; hence, this endpoint was not evaluated.|Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population|||||
763471|NCT00655824|Secondary|Number of Participants Achieving ACR70|ACR70 is achieved if the participant has 70% improvement from Baseline in: TJC and SJC and in 3 out of 5 of following assessment (A) ; participant pain A , participant global A, physician global A on a visual analogue scale (VAS: a 10 cm scale ranges from ‘no pain’ to ‘severe pain’ and the distance marked by the participant from the “no pain” end is his joint pain score).and participant self-assessed disability and C-reactive protein. The sponsor discontinued the IV administration development program for RA, and this study was terminated early; hence, this endpoint was not evaluated.|Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population|||||
763472|NCT00655824|Secondary|Number of Participants Achieving ACR50|ACR50 is achieved if the participant has 50% improvement from Baseline in: TJC and SJC and in 3 out of 5 of following assessment (A) ; participant pain A , participant global A, physician global A on a visual analogue scale (VAS: a 10 cm scale ranges from ‘no pain’ to ‘severe pain’ and the distance marked by the participant from the “no pain” end is his joint pain score).and participant self-assessed disability and C-reactive protein. The sponsor discontinued the IV administration development program for RA, and this study was terminated early; hence, this endpoint was not evaluated.|Baseline of each TCand 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population|||||
763473|NCT00655824|Secondary|Number of Participants Achieving American College of Rheumatology (ACR)20|"ACR20 is achieved if the participant has 20% improvement from Baseline in TJC and SJC and in 3 out of 5 of following assessments (A); participant pain A, participant global A, physician global A on a visual analog scale (VAS: a 10 cm scale ranging from no pain to severe pain; the distance marked by the participant from the “no pain” end is his joint pain score), participant self-assessed disability, and C-reactive protein. The sponsor discontinued the IV administration development program for RA, and this study was terminated early; hence, this endpoint was not evaluated."|Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population|||||
763474|NCT00655824|Secondary|Ofatumumab Serum Concentration|Blood samples of participants were collected for the measurement of ofatumumab concentration in the blood. The blood samples were collected before infusion (BI) (baseline of that particular treatment course) and at the end of infusion (EI) of ofatumumab.|Before infusion and at the end of infusion for each Treatment Course (8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next TC; up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial vi|FAS Population. Only participants with data available at the particular time points were analyzed.||Nanograms per milliliter (ng/mL)||Standard Deviation|Mean
763475|NCT00655824|Secondary|Time to Re-treatment in Each Treatment Course|Time to re-treatment in each treatment course (TC) is defined as the time from the first infusion of ofatumumab until the date of the first infusion of the first re-treatment course. The data presented reflect the time to re-treatment, which is defined as the time in days between the first infusion of each TC and the first infusion of the following TC. For TC 1, time to re-treatment is defined as the time between the first infusion in TC 1 and the first infusion in TC 2; similarly, for TC 2 it is the time between the first infusion of TC 2 and the first infusion of TC 3.|Week 16 to Week 104 of each treatment course (up to 125 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population. Only participants available at the indicated time point were assessed.||days||Standard Deviation|Mean
763476|NCT00655824|Secondary|Minimum Change From Baseline in DAS28 Over the Course of Weeks 1 to 24 in Each Treatment Course, Based on C-reactive Protein (CRP)|DAS28(CRP) is a numeric outcome that measures RA activity based on the CRP (used to monitor acute inflammatory phases of RA), tender JC, swollen JC, and participant’s global assessment of disease activity on a 100 millimeter Visual Analog Scale. DAS28 values range from 0 (no activity) and upwards; increasing values indicate increasing activity (there is no upper limit on the scale). Change from baseline (CFB) was calculated at all visits; however, minimum CFB was calculated as the minimum CFB obtained over the course of weeks 1-24 of each treatment cycle.|Baseline (last visit prior to dosing in each TC) and last visit of each TC (8 wk post infusion, then every 4 wk until Wk 24; up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population. One participant withdrew during the first infusion due to AEs of rash and pruritis. Only participants available at the indicated time point were assessed.||scores on a scale||Standard Deviation|Mean
763490|NCT00655863|Secondary|Change From Baseline in Postprandial C-Peptide|The change in postprandial C-peptide collected at each week indicated relative to baseline.|Baseline, Week 4 and Week 16.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.||ng/mL||Standard Error|Least Squares Mean
763491|NCT00655863|Secondary|Change From Baseline in Fasting Plasma Glucose|The change in fasting plasma glucose collected at each week indicated relative to baseline.|Baseline, Week 4, Week 8 and Week 16.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.||mg/dL||Standard Error|Least Squares Mean
763477|NCT00655824|Secondary|Minimum Change From Baseline in Disease Activity Score Based on 28 Joints (DAS28) Over the Course of Weeks (Wk) 1 to 24 in Each Treatment Course (TC), Assessed by Erythrocyte Sedimentation Rate (ESR; Rate at Which Red Blood Cells Sediment in 1 Hour)|DAS28(ESR) is a numeric outcome that measures RA activity based on the ESR (a non-specific general indicator of inflammation), tender joint count (JC), swollen JC, and participant’s global assessment of disease activity on a 100 millimeter Visual Analog Scale. DAS28 values range from 0 (no activity) and upwards; increasing values indicate increasing activity (there is no upper limit on the scale). Change from baseline (CFB) was calculated at all visits; however, minimum CFB was calculated as the minimum CFB obtained over the course of weeks 1-24 of each treatment cycle.|Baseline (last visit prior to dosing in each TC) and last visit of each TC (8 wk post infusion, then every 4 wk until Wk 24; up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population. One participant withdrew during the first infusion due to adverse events (AEs) of rash and pruritus. Only participants available at the indicated time point were assessed. Minimum change from baseline is defined as the smallest change at any visit over the course of Weeks 1 to 24 of each treatment cycle.||scores on a scale||Standard Deviation|Mean
763478|NCT00655824|Primary|Time to Treatment Withdrawal|Time to treatment withdrawal was defined as the time from the first infusion of ofatumumab until the date of treatment withdrawal. The sponsor discontinued the intravenous route of administration development program for rheumatoid arthritis (RA), and this study was terminated early; hence, this primary endpoint was not evaluated.|From Baseline up to 144 weeks|Full Analysis Set (FAS) Population: all participants who were exposed to study drug irrespective of their compliance to the planned course of treatment.|||||
763479|NCT00655850|Secondary|Objective Response Rate|The percentage of patients who achieve a complete response and partial response according to RECIST criteria (v1.0).|Baseline up to 12 months|Participants with advanced chemotherapy naïve with non-squamous non-small cell lung cancer.||Participants|||Count of Participants
763480|NCT00655850|Secondary|Overall Survival (OS)|Overall Survival is defined as the number of days from the day the subject started treatment to the day the subject experiences death or lost to follow up.|Baseline up to 84 months|Participants with advanced chemotherapy naïve with non-squamous non-small cell lung cancer.||months||Full Range|Median
763481|NCT00655850|Secondary|Number of Participants With Adverse Events|All adverse events will be recorded as to the grade and relationship to the study drug in accordance with the Common Terminology Criteria for Adverse Events (CTCAE v 3.0)|Baseline through duration of treatment an average of 1 year|Participants with advanced chemotherapy naïve with non-squamous non-small cell lung cancer.||participants|||Number
763482|NCT00655850|Primary|Progression-Free Survival (PFS)|Progression Free Survival is defined as the number of days from the day the subject started treatment to the day the subject experiences disease progression in accordance with the Response Evaluation Criteria Solid Tumors (RECIST v1.0). The RECIST criteria indicates progression as a 20% increase in the total tumor measurement over nadir value or the appearance of new lesions.|Baseline to 24 months|Participants with advanced chemotherapy naïve with non-squamous non-small cell lung cancer.||months||95% Confidence Interval|Median
763483|NCT00655863|Secondary|Change From Baseline in Endothelial Function Through Pulse Wave Tonometry|Pulse wave tonometry performed before the meal and 2 hours postmeal using one recording consisting of 15 to 20 sequentially recorded radial artery waveforms collected at each assessment.|Baseline and Week 16.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.||mmHg||Standard Error|Least Squares Mean
763484|NCT00655863|Secondary|Change From Baseline in e-Selectin|The change in e-Selectin collected at each week indicated relative to baseline.|Baseline, Week 4 and Week 16.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.||ng/mL||Standard Error|Least Squares Mean
763485|NCT00655863|Secondary|Change From Baseline in Anti-Intercellular Adhesion Molecule (ICAM)|The change in ICAM collected at each week indicated relative to baseline.|Baseline, Week 4 and Week 16.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.||ng/mL||Standard Error|Least Squares Mean
763486|NCT00655863|Secondary|Change From Baseline in Anti-Vascular Cell Adhesion Molecule (VCAM)|The change in VCAM collected at each week indicated relative to baseline.|Baseline, Week 4 and Week 16.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.||ng/mL||Standard Error|Least Squares Mean
763487|NCT00655863|Secondary|Change From Baseline in Adiponectin|The change in adiponectin collected at each week indicated relative to baseline.|Baseline, Week 4 and Week 16.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.||µg/mL||Standard Error|Least Squares Mean
763488|NCT00655863|Secondary|Change From Baseline in High-sensitive C-reactive Protein (Hs-CRP)|The change in hs-CRP collected at each week indicated relative to baseline.|Baseline, Week 4 and Week 16.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.||mg/L||Standard Error|Least Squares Mean
763503|NCT00656058|Secondary|Number of Non-Infected Participants at Baseline With Cysteinyl Leukotriene Receptor Expression on Cluster of Differentiation (CD4) and CD8 T Cells, Granulocytes, and Eosinophils in Bronchoalveolar Lavage (BAL) Fluid|Fluid from the bronchoalveolar lavage in adult participants (pediatric optional) will be collected and sent to the lab to be evaluated for infectious diseases by flow cytometry|Day 1 of study|||participants|||Number
763492|NCT00655863|Secondary|Change From Baseline in Glycosylated Hemoglobin|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at each week indicated relative to baseline.|Baseline, Week 8 and Week 16.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
763493|NCT00655863|Secondary|Postprandial Changes Over Time From Baseline for Glucagon|Postprandial changes over time at each week indicated relative to baseline.|Baseline, Week 4 and Week 16.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.||pg/mL||Standard Error|Least Squares Mean
763494|NCT00655863|Secondary|Postprandial Changes Over Time From Baseline for Insulin|Postprandial changes over time at each week indicated relative to baseline.|Baseline, Week 4 and Week 16.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.||uIU/mL||Standard Error|Least Squares Mean
763495|NCT00655863|Secondary|Postprandial Changes Over Time From Baseline for Glucose|Postprandial changes over time at each week indicated relative to baseline.|Baseline, Week 4 and Week 16.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.||mg/dL||Standard Error|Least Squares Mean
763496|NCT00655863|Secondary|Postprandial Changes Over Time From Baseline for Glucagon-like Peptide-1 (GLP-1)|Postprandial changes over time at each week indicated relative to baseline.|Baseline, Week 4 and Week 16.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.||pmol/L||Standard Error|Least Squares Mean
763497|NCT00655863|Secondary|Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters.|Postprandial incremental area under the curve changes for very-low-density lipoprotein (VLDL) Apo B-48, VLDL Apo B 100, VLDL2 Apo B-48, VLDL2 Apo B 100, chylomicron Apo B-48, chylomicron Apo B 100, and intermediate density lipoprotein (IDL) Apo B-48, IDL Apo B 100, and triglyceride-rich remnant (TRR) lipoproteins from 0 to 8 hours postdose at week 4 and week 16 relative to baseline.|Baseline, Week 4 and Week 16.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.||mg.h/dL||Standard Error|Least Squares Mean
763498|NCT00655863|Secondary|Change From Baseline in Postprandial Incremental Area Under the Curve Changes for Lipid Parameters.|The change in postprandial incremental area under the plasma concentration-time curve for very-low-density lipoprotein (VLDL) cholesterol, VLDL triglycerides, VLDL2 cholesterol, VLDL2 triglycerides, chylomicron cholesterol, chylomicron triglycerides, intermediate-density lipoprotein (IDL) cholesterol, and IDL triglycerides from 0 to 8 hours postdose at week 4 and week 16 relative to baseline.|Baseline, Week 4 and Week 16.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.||mg.h/dL||Standard Error|Least Squares Mean
763499|NCT00655863|Secondary|Change From Baseline in Postprandial Incremental Area Under the Curve for Total Triglycerides at Week 4.|The change in postprandial incremental area under the plasma concentration-time curve from 0 to 8 hours (AUC(0-8h)) postdose at week 4 relative to baseline.|Baseline and Week 4.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.||mg.h/dL||Standard Error|Least Squares Mean
763500|NCT00655863|Primary|Change From Baseline in Postprandial Incremental Area Under the Curve for Total Triglycerides at Week 16.|The change in postprandial (after eating a meal) incremental area under the plasma concentration-time curve from 0 to 8 hours (AUC (0-8h)) postdose at week 16 relative to baseline.|Baseline and Week 16.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.||mg.h/dL||Standard Error|Least Squares Mean
763501|NCT00655889|Primary|Number of Responders Based on the Average Patient Evaluation of Change From Baseline for All Treated Areas on the Global Ordinal Rating Scale (GORS)|A patient was considered a responder in this outcome measure if the average patient's GORS score for all treatment areas was greater than 0. On the GORS, a score of -2 (much worsening from baseline) was the worst and +2 (great improvement from baseline) was the best.|Baseline (prior to first study treatment) compared to six months after first treatment|Subjects who received at least one treatment during the study were included in the Intent to Treat population||participants|||Number
763502|NCT00655889|Primary|Number of Responders Based on the Average Investigator Evaluation of Change From Baseline for All Treated Areas on the Global Ordinal Rating Scale (GORS)|A patient was considered a responder in this outcome measure if the average Investigator's GORS score for all treatment areas was greater than 0. On the GORS, a score of -2 (much worsening from baseline) was the worst and +2 (great improvement from baseline) was the best.|Baseline (prior to first study treatment) compared to six months after first treatment|Subjects who received at least one treatment during the study were included in the Intent to Treat population||participants|||Number
763671|NCT00670462|Secondary|Physical Activity, Energy Expenditure|change from baseline in energy expenditure at 12 months|12 months|||kcal/wk||Standard Error|Mean
763507|NCT00656058|Primary|Number of Participants With Improved, Stable or Declined Forced Expiratory Volume 1 (FEV-1) Slope at 6 Months|FEV-1 slope of decline was generated using regression line of FEV-1 value vs. days post hematopoietic stem cell transplant. Responsive disease (RD) for the slope of FEV-1 change will be an increase in the slope of absolute FEV-1. Progressive disease (PD) for the slope of FEV-1 change will be a decrease in the slope of absolute FEV-1. Stable disease (SD) for the slope of FEV-1 change will be a 0 change in FEV-1 slope.|180 days|||participants|||Number
763508|NCT00656058|Primary|Number of Participants With Stable or Improved Predicted Forced Expiratory Volume 1 (FEV-1) With Published Literature|Responsive disease (RD) will be defined as ≥15% absolute improvement in the percentage predicted FEV-1. Progressive disease (PD) will be defined as >15% decrease in FEV-1 documented on 2 pulmonary function test (PFT) evaluations greater than 2 weeks apart. Stable disease (SD) will be defined as <15% change in the absolute FEV-1.|180 days|No data is available for the one missing participant.||participants|||Number
763509|NCT00656084|Secondary|Progression-free Survival Rate at 1 Year.|PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date.|1 year.|ITT population||Probability of Progression-free Survival||95% Confidence Interval|Number
763510|NCT00656084|Secondary|Overall Survival (OS) Rate at 1 Year|OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.|1 year.|ITT population||Probability of Survival||95% Confidence Interval|Number
763511|NCT00656084|Secondary|Duration of Response|"The duration of response is measured from the time measurement criteria are first met for CR/PR until the first date that recurrent or progressive disease is objectively documented.
CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD."|From date of randomization until the date of first documented progression or the date of death from any cause, whichever came first, assessed up to 33 months.|For patients who achieve a major objective response (CR or PR) the time to response will be assessed as the date of registration to the date of response.||months||Full Range|Median
763512|NCT00656084|Primary|Objective Response Rate (CR + PR)|Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.|2 years|Evaluable Population||percentage of participants||95% Confidence Interval|Number
763513|NCT00656136|Secondary|Objective Response Rate (OR)|OR is defined as complete response (CR) and partial response (PR). Assessed by central independent review according to RECIST 1.0.|From randomization to disease progression, death or the data cutoff on 07 July 2010, an average of 3.3 months|Randomized set was all patients who were randomized and for this study all of these patients received at least one dose of study medication.||Percentage of patients with OR||95% Confidence Interval|Number
763514|NCT00656136|Secondary|Progression-free Survival (PFS)|PFS is defined as time from randomisation to disease progression or death whichever occurs first. Assessed by central independent review according to the Response Evaluation Criteria in Solid Tumours version 1.0 (RECIST 1.0).|From randomization to disease progression, death or the data cutoff on 07 July 2010, an average of 3.3 months|Randomized set was all patients who were randomized and for this study all of these patients received at least one dose of study medication.||Months||95% Confidence Interval|Median
763515|NCT00656136|Primary|Overall Survival|"Overall survival was the duration from the date of randomization to the date of death. Patients who were alive were censored at the last contact date prior to the database lock.
For the primary analysis 11 patients were lost to follow-up and were censored at the last contact date when they were known to be still alive. Primary analysis data cut-off date was 08 July 2010.
For the final analysis 13 patients were lost to follow-up and were censored at the last contact date when they were known to be still alive. Final analysis data cut-off date was 04 October 2013."|From randomization until death or the last patient out date, an average of 12 months|Randomized set was all patients who were randomized and for this study all of these patients received at least one dose of study medication.||Months||95% Confidence Interval|Median
763516|NCT00656175|Primary|Baseline to 24-week Change in Visceral Adipose Tissue Volume (cm^2)|Adipose tissue volumes were measured via single slice L4-L5 CT scan, and volumes were calculated using cm^2, not cm^3, as is standard protocol at the Tufts University Body Composition Reading Center. The authors acknowledge that cm^2 uses area as a surrogate for volume, but this protocol is well-accepted in our field.|Baseline and 24 weeks|||cm^2||Inter-Quartile Range|Median
763517|NCT00656201|Primary|Percentage of Pregnant Patients After IVF Treatments|Percentage of pregnant patients after IVF treatments who received either Crinone or IM Progesterone after oocyte retrieval|16 weeks|Number of participants for analysis was determined by completion of the IVF cycle using the specified medications, either Crinone or IM Progesterone||percentage of participants|||Number
763518|NCT00656292|Secondary|Median Concentration of Tumor Necrosis Factor-Alpha (TNF)|Tumor Necrosis Factor Alpha is a cell signaling protein (cytokine) involved in systemic inflammation and is one of the cytokines that make up the acute phase reaction. TNF is important to the body because it helps regulate the response of the immune system to a foreign object, especially to the present cancerous tumor. It promotes inflammation, produces other cells used in the inflammatory response, and can help cells heal. The normal range is 5 to 27.2 pg/ml.|baseline, at the start of the surgical procedure (0 hrs), 8 hrs, 24 hrs, 48 hrs, 72 hrs|||pg/ml||Inter-Quartile Range|Median
763519|NCT00656292|Secondary|Median Concentration of Interleukin-6 (IL-6)|Interleukin-6 (IL-6) may be used to help evaluate a person who has a condition associated with inflammation, such as lupus or rheumatoid arthritis, or with infection, such as sepsis. It may also be used in the evaluation of diabetes or cardiovascular disease. IL-6 is a cytokine, a protein produced by immune cells that acts on other cells to help regulate and/or promote an immune response. It also stimulates the production of acute phase reactants, proteins that increase in the blood with conditions that cause inflammation or tissue injury. Circulating IL-6 can be found in the blood of normal individuals in the 1 pg/mL range, with slight elevations during the menstrual cycle, modest elevations in certain cancers (melanoma) (10 pg/mL), and large elevations after surgery (30-430 pg/mL).|baseline, at the start of the surgical procedure (0 hrs), 8 hrs, 24 hrs, 48 hrs, 72 hrs|||ng/ml||Inter-Quartile Range|Median
763672|NCT00670462|Secondary|Mood State||baseline, 6, 12, 18, and 30 months||||||
763673|NCT00670462|Secondary|Triglycerides||baseline, 6, 12, 18, and 30 months||||||
763520|NCT00656292|Secondary|Median Concentration of Creatine Kinase (CK)|A creatine kinase test may be used to detect inflammation of muscles or muscle damage due to muscle disorders. A person may have muscle injury with few or nonspecific symptoms, such as weakness, fever, and nausea, that may also be seen with a variety of other conditions. A healthcare practitioner may use a CK test to help detect muscle damage in these cases, especially if someone is taking a drug such as a statin. Normal values at rest are usually between 60 and 174 IU/L.|baseline, at the start of the surgical procedure (0 hrs), 8 hrs, 24 hrs, 48 hrs, 72 hrs|||U/L||Inter-Quartile Range|Median
763521|NCT00656292|Secondary|Median Concentration of C-Reactive Protein (CRP)|C-reactive protein (CRP) is a substance produced by the liver in response to inflammation. Normal CRP levels are below 3.0 mg/L.|baseline, at the start of the surgical procedure (0 hrs), 8 hrs, 24 hrs, 48 hrs, 72 hrs|||mg/L||Inter-Quartile Range|Median
763522|NCT00656292|Secondary|Median Concentration of Alanine Aminotransferase (ALT)|An enzyme normally present in liver and heart cells that is released into the bloodstream when the liver or heart is damaged. The blood ALT levels are elevated with liver damage (for example, from viral hepatitis) or with an insult to the heart (for example, from a heart attack). The normal range is 7 to 56 U/L.|baseline, at the start of the surgical procedure (0 hrs), 8 hrs, 24 hrs, 48 hrs, 72 hrs|||U/L||Inter-Quartile Range|Median
763523|NCT00656292|Primary|Median Concentration of Aspartate Aminotransferase (AST)|Description: AST is an enzyme found in high amounts in liver, heart, and muscle cells. This test is mainly done along with other tests such as alkaline phosphatase and bilirubin to diagnose and monitor liver disease. This test evaluates hepatocyte integrity, as serum levels of this enzyme rise in response to a variety of forms of injury to hepatic cells. The normal range is 10 to 40 U/L.|baseline, at the start of the surgical procedure (0 hrs), 8 hrs, 24 hrs, 48 hrs, 72 hrs|||U/L||Inter-Quartile Range|Median
763524|NCT00656370|Secondary|Subject's Global Preference for Infusion (Left vs. Right Thigh)||End of infusion||||||
763525|NCT00656370|Secondary|Time From the Beginning of Infusion Until the Thigh Circumference Returns to Within 5% of Baseline Circumference.||Before the infusion until discharge||||||
763526|NCT00656370|Secondary|Change in Circumference of the Thigh at the Infusion Site||Before the infusion, during the infusion, after the infusion, and discharge||||||
763527|NCT00656370|Secondary|Average Infusion Flow Rate (mL/hr) Derived From the Time to Infuse up to 500mL of Solution||During infusion||||||
763528|NCT00656370|Secondary|Safety Assessment of 15 Participants Who Were Included in the Safety Data Set.|Safety outcome measures included adverse events (AEs), physical examinations, and vital signs.|Baseline, Mid-Infusion Right and Left, Post-Infusion Right and Left, Discharge Right and Left|||participants|||Number
763529|NCT00656370|Primary|The Subject's Assessment of Discomfort at the Infusion Site on a Visual Analog Scale (VAS).|Subject's self-assessment of discomfort at the infusion site by means of a validated visual analogue scale (VAS) with a range of 0 mm (no discomfort) to 100 mm (worst possible discomfort), for the comparison of subcutaneous (SC) infusion of NS versus LR, each following an SC slow-push injection of 150 U Hylenex.|Approximate times which ranged from zero minutes at baseline to maximal post-infusion of 240 minutes.|15 subjects were randomized and completed stage 1||mm||Standard Deviation|Mean
763530|NCT00656448|Secondary|Number of Participants With Complete Remission|International Working Group (IWG) criteria for responses defined as: Complete Remission (CR) - Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count > 1.0 x 10^9/L and platelet count > 100 x 10^9/L, and normal bone marrow differential (< 5% blasts); Partial remission (PR): as CR except for presence of 5-25% marrow blasts and with a decrease of marrow blast at least 50%.|Baseline, weekly or until disease progression|||participants|||Number
763531|NCT00656448|Primary|Median Number of Participant Transfusions Required During 12 Weeks of Treatment|"The number and frequency of packed red blood cells (PRBC) transfusions assessed and compared between two groups, treatment group (Procrit) and standard care group (No Procrit). Participants log all PRBC transfusions. Reported are the number of transfusions in the treatment arm during induction and consolidation chemotherapy with the concomitant use of epoetin alfa during therapy, and in the standard arm those that occured during same 12 week period."|12 weeks|||Transfusions per Participant||Full Range|Median
763532|NCT00656474|Secondary|Percentage of Wound Epithelialized|The percentage of wound epithelialized was assessed at Day 15 post laser ablation.|Day 15 post laser ablation.|Analysis was Per Protocol.||percent|||Number
763533|NCT00656474|Primary|Time to Complete Wound Closure (Epithelialization)|Subjects were evaluated every 2 days from the time of the laser procedures for the first 10 days and then seen every 2 weeks for 4 weeks. Efficacy was assessed based on the time to complete epithelialization in terms of the number of days from Day 1 (day of laser ablation) to the day on which complete epithelialization was observed.|Over the course of 1 month following the initial treatment.|Analysis was Per Protocol.||days||95% Confidence Interval|Median
763534|NCT00656487|Primary|Change From Day 0 in Performance on the Cambridge Neuropsychological Test Automated Batteries Spatial Working Memory (CANTAB SWM) Mean Time To First Response at Day 28|The CANTAB SWM task is a validated computer-based testing instrument assessing the memory component of executive function. Mean Time To First Response is a measure of latency and is unbounded. Change = (Day 28 Time - Day 0 Time). A more negative result indicates greater improvement.|Day 0 and Day 28|||milliseconds||Standard Deviation|Mean
763535|NCT00656487|Primary|Change From Day 0 in Performance on the Cambridge Neuropsychological Test Automated Batteries Spatial Working Memory (CANTAB SWM) Total Errors at Day 28|The CANTAB SWM task is a validated computer-based testing instrument assessing the memory component of executive function. Total Errors are a measure of performance and are unbounded. Change = (Day 28 Score - Day 0 Score). A more negative result indicates greater improvement.|Day 0 and Day 28|||units on a scale||Standard Deviation|Mean
763536|NCT00656487|Primary|Change From Day 0 in Performance on the Cambridge Neuropsychological Test Automated Batteries Spatial Working Memory (CANTAB SWM) Strategy Score at Day 28|The CANTAB SWM task is a validated computer-based testing instrument assessing the memory component of executive function. Strategy Score is an estimate of use of the most efficient strategy to complete the task. Scores range from 8-56; higher scores equate to poor use of the most efficient strategy. Change = (Day 28 Score - Day 0 Score). A more negative result indicates greater improvement.|Day 0 and Day 28|||units on a scale||Standard Deviation|Mean
763674|NCT00670462|Secondary|HDL||baseline, 6, 12, 18, and 30 months||||||
763675|NCT00670462|Secondary|Insulin||baseline, 6, 12, 18, and 30 months||||||
763537|NCT00656487|Primary|Plasma Cortisol|Blood samples were obtained and plasma concentrations were determined using validated enzyme-linked immunosorbent assay (ELISA) techniques at 28 days following single dose administration of rimonabant or placebo, or commencement of monitoring, during the double-blind period.|Day 28|Two control participants and one placebo participant who completed the double blind / monitoring portion of the trial did not have samples available for analysis at Day 28. The control participants did not have blood drawn; the placebo participant returned a non-detectable value.||ug/dL||Standard Deviation|Mean
763538|NCT00656487|Primary|Plasma Norepinephrine|Blood samples were obtained and plasma concentrations were determined using validated enzyme-linked immunosorbent assay (ELISA) techniques at 28 days following single dose administration of rimonabant or placebo, or commencement of monitoring, during the double-blind period.|Day 28|Five control participants who completed the double blind / monitoring portion of the trial did not have samples available for analysis at Day 28. Two participants did not have blood drawn; two additional participant sample results were not returned by the laboratory; and one participant did not return a result due to an ELISA kit error.||ng/mL||Standard Deviation|Mean
763539|NCT00656487|Primary|Withdrawal Symptom Severity on the Marijuana Withdrawal Checklist (MWC) at 28 Days Following Single Dose Administration of Rimonabant or Placebo, or Commencement of Monitoring, During the Double-Blind Period|The MWC is a 28-item instrument that is used to assess the severity of frequently reported cannabis withdrawal symptoms. Each item on the measure is recorded as a severity rating between 0-3 where a zero indicates not present and a three indicates severe. The severity rating of each item was summed to obtain a single marijuana withdrawal severity score ranging between 0- 84. A lower score indicates less severe withdrawal.|Day 28|One participant in the control group who completed monitoring during the double-blind portion of the trial did not complete a Marijuana Withdrawal Checklist at Day 28.||units on a scale||Standard Deviation|Mean
763540|NCT00656513|Secondary|Quality of Life (QOL) as Measured by the University of Washington Head and Neck Questionnaire (UWHNSS) Phase III|The UWHNSS includes ten categories—pain, disfigurement, activity, recreation/entertainment, employment, eating, saliva, taste, speech, mucus/phlegm. Patient scores on the UWHNSS range from 0 to 100 with higher scores indicating declining quality of life. Change in total score was calculated by subtracting baseline from follow-up , thus a positive change score indicates a worsening while a negative change score indicates an improvement.|Baseline and 9 months from randomization.|Eligible randomized patients with both baseline and 9-month UWHNSS total scores.||units on a scale||Inter-Quartile Range|Median
763541|NCT00656513|Secondary|Change From Baseline in Unstimulated Whole Salivary Production (WSP) at 4, 6, 9 and 15 Months (Phase III)|Basal whole salivary production (WSP) was measured by expectoration weight, with one gram of saliva produced considered as one ml of saliva. WSP is expressed in ml/min calculated by dividing the measured weight or volume of WSP by five. Procedure: Patients refrain from eating, drinking, and smoking at least two hours prior to each measurement. For each measurement, patients are asked to expectorate continuously into a pre-weighed dry plastic container over a 5-minute period without swallowing. The collected saliva with the plastic container will be weighed (total weight) immediately after each collection. The total weight minus the weight of the container is the weight or volume of whole saliva collected.|Pre-treatment to 4, 6, 9 and 15 months from randomization|Eligible randomized patients with both baseline and respective follow-up (4,6, 9,15 months) WSP measurements.||ml/min||Inter-Quartile Range|Median
763542|NCT00656513|Secondary|Change From Baseline in Stimulated Whole Salivary Production (WSP) at 4, 6, 9 and 15 Months (Phase III)|Stimulated (citric acid primed) whole salivary production (WSP) was measured by expectoration weight, with one gram of saliva produced considered as one ml of saliva. WSP is expressed in ml/min calculated by dividing the measured weight or volume of WSP by five. Procedure: Patients refrain from eating, drinking, and smoking at least two hours prior to each measurement. Stimulation is elicited by asking patients to rinse 5 ml of 2% citric acid solution in the mouth for 15 seconds and then completely expectorating the citric acid. For each measurement, patients are asked to expectorate continuously into a pre-weighed dry plastic container over a 5-minute period without swallowing. The collected saliva with the plastic container will be weighed (total weight) immediately after each collection. The total weight minus the weight of the container is the weight or volume of whole saliva collected.|Baseline, 4, 6, 9 and 15 months from randomization|Eligible patients with both baseline and respective follow-up (4,6, 9,15 months) WSP measurements.||ml/min||Inter-Quartile Range|Median
763543|NCT00656513|Secondary|Change From Baseline in Symptom Burden at 4, 6, 9 and 15 Months (Phase III)|Symptom burden is measured by the University of Michigan Xerostomia Related Quality of Life Scale (XeQOLS). The XeQOLS is a validated patient-reported 15-item assessment scale with 4 domains: physical functioning,pain/discomfort, personal/psychologic functioning, and social functioning. The domain score is the average of all responses on a given domain and can range from 0 to 4, with higher scores indicating increased symptom burden. Change in symptom burden is calculated by subtracting the baseline score from the 9-month score such that a negative change indicates an improvement of the symptom burden.|Baseline, 4, 6, 9 and 15 months from randomization|Eligible patients with both baseline and respective follow-up (4,6, 9,15 months) XeQOLS scores.||units on a scale||Inter-Quartile Range|Median
763544|NCT00656513|Secondary|Change From Baseline in Overall Xerostomia Burden at 4, 6, and 15 Months (Phase III)|Xerostomia burden is measured by the University of Michigan Xerostomia Related Quality of Life Scale (XeQOLS). The XeQOLS is a validated patient-reported 15-item assessment scale with 4 domains: physical functioning,pain/discomfort, personal/psychologic functioning, and social functioning.The score is the average of all responses of all domains and can range from 0 to 4, with higher scores indicating increased xerostomia burden. Change in xerostomia burden is calculated by subtracting the baseline score from the 9-month score such that a negative change indicates an improvement of the xerostomia burden.|Baseline, 4, 6, and 15 months from randomization|Eligible patients with both baseline and respective follow-up (4,6,15 months) XeQOLS scores.||units on a scale||Inter-Quartile Range|Median
763557|NCT00656669|Secondary|To Evaluate the Safety of Paclitaxel Plus Sunitinib When Given in Combination as Neoadjuvant Therapy|This measure determines the number of patients who had Grade 3/4 Adverse Events that were related to treatment while the patient was on paclitaxel plus sunitinib.|end of cycle 1 (sunitinib monotherapy) to end of cycle 5 (paclitaxel/sunitinib therapy)|All patients who were on paclitaxel plus sunitinib.||participants|||Number
763558|NCT00656669|Secondary|Pathological Complete Response (pCR) Rate for Patients Treated With Sunitinib/Paclitaxel Followed by AC as Neoadjuvant Therapy for Breast Cancer||screening through surgery|All patients who had surgery.||percentage of participants||95% Confidence Interval|Number
763545|NCT00656513|Secondary|Phase II: Pecentage of Patients With Beneficial Treatment Response|This secondary objective was to evaluate the effect of ALTENS treatment on overall radiation-induced xerostomia burden by looking at treatment response. Treatment response was determined by a reduction of at least 20% from baseline to 6 months in the University of Michigan Xerostomia Related Quality of Life Scale (XeQOLS). The XeQOLS is a validated patient-reported 15-item assessment scale with 4 domains: physical functioning,pain/discomfort, personal/psychologic functioning, and social functioning.The score is the average of all responses of all domains and can range from 0 to 4. Higher scores indicate increased xerostomia burden. This scale has high reproducibility and sensitivity. For the first and second stage analyses, 4 and 10 patients, respectively, must respond to treatment in order to proceed to the phase III component.|Pre-treatment and 6 months from registration|Eligible patients who started treatment and have both baseline and 6-month XeQOLS scores||percentage of participants||95% Confidence Interval|Number
763546|NCT00656513|Primary|Phase III: Change From Baseline in Overall Xerostomia Burden at 9 Months|Xerostomia burden is measured by the University of Michigan Xerostomia Related Quality of Life Scale (XeQOLS). The XeQOLS is a validated patient-reported 15-item assessment scale with 4 domains: physical functioning,pain/discomfort, personal/psychologic functioning, and social functioning.The score is the average of all responses of all domains and can range from 0 to 4, with higher scores indicating increased xerostomia burden. Change in xerostomia burden is calculated by subtracting the baseline score from the 9-month score such that a negative change indicates an improvement of the xerostomia burden.|Baseline (randomization) and 9 months|Eligible randomized patients with both baseline and 9 month XeQOLS scores||units on a scale||Inter-Quartile Range|Median
763547|NCT00656513|Primary|Phase II: Treatment Compliance (Number of Compliant Patients)|Patients completing at least 19 out of 24 ALTENS therapy sessions were categorized as compliant. Fleming’s two-stage was used, assuming a successful target compliance rate of 80%, statistical power of 0.87, and a type I error rate of 0.13. If fewer than 9 of the first 13 patients were compliant, then treatment delivery will be deemed not feasible. If there were between 9-12 compliant patients, the second stage analysis would be required to determine feasibility of treatment delivery. If all 13 patients are compliant, treatment delivery will immediately be deemed feasible. The second stage analysis required at least 31 compliant out of 39 overall patients for the treatment delivery to be deemed feasible.|Randomization to 12 weeks|Eligible patients starting protocol treatment||Participants|||Count of Participants
763548|NCT00656617|Secondary|Participant Response|Number of participants with response assessed according RECIST: Complete Response (CR) defined as normalization of marrow (< 5% blasts) and of peripheral blood counts (neutrophil count > 1.109/L, platelet count > 100 x 109/L). Partial response (PR) defined as for CR in terms of peripheral counts but with reduction of marrow blasts by >50% compared to pretreatment values but above <5%. Complete Response without platelet recovery (CRp) = CR, but platelets <100 x 109/L. Progressive disease (PD) defined as increase of blasts to > 10% after an initial response.|Monitoring with each 4 week cycle, up to 18 cycles of treatment|Four (4) participants were not treated therefore not evaluable for the outcome assessment.||participants|||Number
763549|NCT00656617|Primary|Progression Free Survival (PFS) at 7 Months|Progression-free survival defined as time from date of randomization to first occurrence of having documented disease progression or death due to any cause, whichever comes first. Progression based on tumor assessments according to Response Evaluation Criteria in Solid Tumors (RECIST). Participants were followed from baseline to disease progression with PFS evaluation at 7 months.|PFS Evaluation at 7 months|Four (4) participants did not receive treatment therefore were not evaluable for outcome assessment.||percentage of participants|||Number
763550|NCT00656630|Secondary|Change From Screening in Craving on the Alcohol Craving Questionnaire-Short Form (ACQ-SF) Total Score at Week 1|The ACQ-SF is an assessment of current drinking urges, difficulty resisting urge and anticipation of positive outcome or relief from negative state by drinking. The Total score ranges from 0 to 7 where a lower score is a better outcome. Change = (Week 1 score - Screening score). The scale is comprised of twelve items (range 0-7) that are averaged to compute the Total score.|2 weeks|One participant in the naltrexone arm who completed the double blind portion of the trial was unable to be analyzed for change in ACQ-SF Total score due to incomplete ACQ-SF questionnaire at Week 1.||units on a scale||Standard Deviation|Mean
763551|NCT00656630|Secondary|Change From Baseline in Sleep Quality on the Pittsburgh Sleep Quality Index (PSQI) Total Score at Week 1|The PSQI is an instrument to assess subjective sleep quality and disturbance. The Total score ranges from 0 to 21 where a lower score is better sleep quality. Change = (Week 1 score - Baseline score). Seven subscales (range 0-3) are summed to compute the Total score.|1 week|Seven participants who completed the double blind portion of the trial were unable to be analyzed for change in PSQI Total score due to incomplete PSQI questionnaire at baseline and/or Week 1.||units on a scale||Standard Deviation|Mean
763552|NCT00656630|Secondary|Change From Baseline in Mood on the Beck Depression Inventory (BDI-II) at Week 1|The BDI-II is a self-rating of severity of depressive symptoms. BDI-II Total scores range from 0-63; a lower score indicates less severe depressive systems and thus is a better outcome. Change = (Week 1 score - Baseline score). The Total score is a sum of the 21 items on the BDI-II instrument, with each item rated from 0-3.|1 week|||units on a scale||Standard Deviation|Mean
763553|NCT00656630|Secondary|Change From Baseline in Standard Drinks Per Week at 1 Week|Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. Change = (Week 1 - Baseline). More negative values indicate less use of alcohol.|1 week|||drinks/week||Standard Deviation|Mean
763554|NCT00656630|Primary|Visual Analog Scale of Craving to Drink at 1 Week Following Administration of Acamprosate or Naltrexone or Placebo During the Double-Blind Period|The four Visual Analog Scale questions assess domains of alcohol craving: the intention to drink, loss of control, relief craving, and urge intensity. The scale ranges from 0-20 where a zero indicates no craving and 20 indicates severe craving; thus, a higher score indicates a worse outcome. Total is a summation of the four subscales (i.e. Strength, Intent, Impulse, Relief) and ranges in value from 0-80 with higher scores indicative of a worse outcome.|1 week|||units on a scale||Standard Deviation|Mean
763555|NCT00656656|Secondary|Number of Patients Who Experienced Side-effects of Treatment|Patients who experienced side-effects were counted. In addition, the nature and severity of side-effects were recorded.|up to 43 months|||Participants|||Count of Participants
763676|NCT00670462|Secondary|Blood Glucose||baseline, 6, 12, 18, and 30 months||||||
763677|NCT00670462|Secondary|Waist-to-hip Ratio at Baseline||baseline|||ratio||Standard Error|Mean
763559|NCT00656669|Secondary|Change in Interstitial Fluid Pressure (IFP) Induced by Paclitaxel Plus Sunitinib After Sunitinib Monotherapy|Participants had their tumor IFP measured at baseline, after sunitinib monotherapy (segment 1) and after sunitinib+paclitaxel (segment 2). This outcome measure is the difference of the mean value from the end of segment 2 (paclitaxel/sunitinib therapy through cycle 5) and end of segment 1 (sunitinib monotherapy) mean value.|end of cycle 1 (sunitinib monotherapy) to end of cycle 5 (paclitaxel/sunitinib therapy) (112 days)|All patients in the paclitaxel plus sunitinib segment||mm Hg||Standard Deviation|Mean
763560|NCT00656669|Primary|Change in Interstitial Fluid Pressure (IFP) Induced by Sunitinib Monotherapy|Participants had their tumor IFP measured at baseline, after sunitinib monotherapy (segment 1) and after sunitinib+paclitaxel (segment 2). This outcome measure is the difference of the mean value from the end of segment 1 (sunitinib monotherapy) and the mean baseline value.|baseline through end of segment 1 (2 weeks)|All patients that had both measures at baseline and endpoint in the sunitinib monotherapy segment||mm Hg||Standard Deviation|Mean
763561|NCT00656799|Primary|Rate of Clearance of Rocuronium From Dialysate|Starting on Day 1 dialysis was performed on four separate occasions using a Fresenius 40008H hemodialyzer, with a hemodiafilter standard helixone membrane FX 600. Dialysate samples were collected from a port in the outflow of the dialyzer before, during and after an average of 6 hours of hemodialysis. The concentrations of rocuronium were determined using a liquid chromatographic assay with mass spectrometric detection. The clearance rate from dialysate at each dialysis session was assessed by averaging across all available collection time points.|Up to Day 7|All subjects pharmacokinetically evaluable consisting of all participants who received a dose of sugammadex and had at least one efficacy measurement||mL/min||Standard Deviation|Mean
763562|NCT00656799|Primary|Rate of Clearance of Sugammadex From Dialysate|Starting on Day 1 dialysis was performed on four separate occasions using a Fresenius 40008H hemodialyzer, with a hemodiafilter standard helixone membrane FX 600. Dialysate samples were collected from a port in the outflow of the dialyzer before, during and after an average of 6 hours of hemodialysis. The concentrations of sugammadex were determined using a liquid chromatographic assay with mass spectrometric detection. The clearance rate from dialysate at each dialysis session was assessed by averaging across all available collection time points.The data from the fourth dialysis are not presented as they were not calculable.|Up to day 7|All subjects pharmacokinetically evaluable consisting of all participants who received a dose of sugammadex and had at least one efficacy measurement||mL/min||Standard Deviation|Mean
763563|NCT00656799|Primary|Rate of Clearance of Rocuronium From Blood|Starting on Day 1 dialysis was performed on four separate occasions using a Fresenius 40008H hemodialyzer, with a hemodiafilter standard helixone membrane FX 600. Blood samples were collected from ports in the arterial and venous tubing of the dialyzer before, during and after an average of 6 hours of hemodialysis. The concentrations of rocuronium were determined using a liquid chromatographic assay with mass spectrometric detection. The clearance rate from blood at each dialysis session was assessed by averaging across all available collection time points.|Up to Day 7|All subjects pharmacokinetically evaluable consisting of all participants who received a dose of sugammadex and had at least one efficacy measurement||mL/min||Standard Deviation|Mean
763564|NCT00656799|Primary|Rate of Clearance of Sugammadex From Blood|Starting on Day 1 dialysis was performed on four separate occasions using a Fresenius 40008H hemodialyzer, with a hemodiafilter standard helixone membrane FX 600. Blood samples were collected from ports in the arterial and venous tubing of the dialyzer before, during and after an average of 6 hours of hemodialysis. The concentrations of sugammadex were determined using a liquid chromatographic assay with mass spectrometric detection. The clearance rate from blood at each dialysis session was assessed by averaging across all available collection time points.|Up to day 7|All subjects pharmacokinetically evaluable consisting of all participants who received a dose of sugammadex and had at least one efficacy measurement||mL/min||Standard Deviation|Mean
763565|NCT00656799|Primary|Clearance of Rocuronium by Dialysis as Measured by the Reduction Ratio (RR)|Starting on Day 1 dialysis was performed on four separate occasions using a Fresenius 40008H hemodialyzer, with a hemodiafilter standard helixone membrane FX 600. Dialysate samples were collected before, and after hemodialysis, with concentrations of rocuronium determined using a liquid chromatographic assay with mass spectrometric detection. The clearance of rocuronium at each dialysis session was calculated by measuring the ratio of plasma concentration at the end of dialysis, average duration of 6 hours, compared with that immediately before the start of dialysis, called the RR.|Up to Day 7|All subjects pharmacokinetically evaluable consisting of all participants who received a dose of sugammadex and had at least one efficacy measurement||Reduction Ratio||Standard Deviation|Mean
763566|NCT00656799|Secondary|Time From Start of Administration of Sugammadex to Recovery of T4/T1 Ratio to 0.7|Neuromuscular function was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing the magnitudes (heights) of the T1 and T4 response at the adductor pollicis muscle with a TOF-Watch® SX. Stimulation continued until the T4/T1 ratio reached at least 0.7. Higher T4/T1 ratios represent greater recovery from neuromuscular blockade; with a value of 1.0 representing full recovery.|Day 1|ITT group consisting of participants who received a dose of sugammadex and had at least one efficacy measurement||Minutes||95% Confidence Interval|Geometric Mean
763567|NCT00656799|Secondary|Time From Start of Administration of Sugammadex to Recovery of T4/T1 Ratio to 0.8|Neuromuscular function was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing the magnitudes (heights) of the T1 and T4 response at the adductor pollicis muscle with a TOF-Watch® SX. Stimulation continued until the T4/T1 ratio reached at least 0.8. Higher T4/T1 ratios represent greater recovery from neuromuscular blockade; with a value of 1.0 representing full recovery.|Day 1|ITT group consisting of participants who received a dose of sugammadex and had at least one efficacy measurement||Minutes||95% Confidence Interval|Geometric Mean
763568|NCT00656799|Secondary|Time From Start of Administration of Sugammadex to Recovery of T4/T1 Ratio to 0.9|Neuromuscular function was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing the magnitudes (heights) of the first twitch (T1) and fourth twitch (T4) response at the adductor pollicis muscle with a TOF-Watch® SX. Stimulation continued until the T4/T1 ratio reached at least 0.9. Higher T4/T1 ratios represent greater recovery from neuromuscular blockade; with a value of 1.0 representing full recovery.|Day 1|Intent To Treat (ITT) group consisting of participants who received a dose of sugammadex and had at least one efficacy measurement||Minutes||95% Confidence Interval|Geometric Mean
763571|NCT00656799|Secondary|Number of Participants With Reoccurrence of Neuromuscular Blockade at Day 1|Neuromuscular function was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing the magnitudes (heights) of the first twitch (T1) and fourth twitch (T4) response at the adductor pollicis muscle with a TOF-Watch® SX. Stimulation continued until the T4/T1 ratio reached at least 0.9. Higher T4/T1 ratios represent greater recovery from neuromuscular blockade; with a value of 1.0 representing full recovery. Reoccurrence of neuromuscular blockade is defined as a decline in the T4/T1 ratio from >= 0.9 to < 0.8 in at least three consecutive measurements.|Day 1|AST consisting of all screened participants who received a dose of sugammadex||participants|||Number
763572|NCT00656799|Secondary|Number of Participants With Physical Examinations|Physical examinations were to be conducted at screening, on Day 1 and 7 days after surgery|Screening up to day 7|AST consisting of all participants who received a dose of sugammadex||participants|||Number
763573|NCT00656799|Secondary|Vital Sign: Mean Heart Rate|Heart rate was measured at the following time points: screening, before rocuronium treatment, before sugammadex treatment, at 2, 5, 10, 20 minutes post-sugammadex treatment, and the day after surgery|Screening up to 1 day after surgery|AST consisting of all participants who received a dose of sugammadex||Beats per minute||Standard Deviation|Mean
763574|NCT00656799|Secondary|Vital Sign: Mean Diastolic Blood Pressure|Diastolic blood pressure was measured at the following time points: screening, before rocuronium treatment, before sugammadex treatment, at 2, 5, 10, 20 minutes post-sugammadex treatment, and the day after surgery|Screening up to 1 day after surgery|AST consisting of all participants who received a dose of sugammadex||mm Hg||Standard Deviation|Mean
763575|NCT00656799|Secondary|Vital Sign: Mean Systolic Blood Pressure|Systolic blood pressure was measured at the following time points: screening, before rocuronium treatment, before sugammadex treatment, at 2, 5, 10, 20 minutes post-sugammadex treatment, and the day after surgery|Screening up to 1 day after surgery|AST consisting of all participants who received a dose of sugammadex||mm Hg||Standard Deviation|Mean
763576|NCT00656799|Secondary|Number of Participants With Medical Device (Near) Incidents|A medical device (near) incident is defined as an occurrence due to inaccurate or inadequate labeling/instructions, or information supplied with a medical device; or malfunction, deterioration or recall of a medical device that could lead to death or serious deterioration in health.|Up to day 7|AST consisting of all participants who received a dose of sugammadex||participants|||Number
763577|NCT00656799|Secondary|Number of Participants With Serious Adverse Events (SAEs)|A SAE is any untoward medical occurrence that at any dose results in the following: death, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, or is a congenital anomaly/birth defect|Up to day 7|AST consisting of all participants who received a dose of sugammadex||participants|||Number
763578|NCT00656799|Secondary|Number of Participants With Pre-treatment Adverse Events (AEs)|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body, whether or not related to the use of a product.|Screening up to Day 1|All Subjects Treated (AST) consisting of participants who received a dose of sugammadex||participants|||Number
763579|NCT00656799|Primary|Clearance of Sugammadex by Dialysis as Measured by the Reduction Ratio (RR)|Starting on Day 1 dialysis was performed on four separate occasions using a Fresenius 40008H hemodialyzer, with a hemodiafilter standard helixone membrane FX 600. Dialysate samples were collected before, and after hemodialysis, with concentrations of sugammadex determined using a liquid chromatographic assay with mass spectrometric detection. The clearance of sugammadex at each dialysis session was calculated by measuring the ratio of plasma concentration at the end of dialysis, average duration of 6 hours, compared with that immediately before the start of dialysis, called the RR.|Up to day 7|All subjects pharmacokinetically evaluable consisting of all participants who received a dose of sugammadex and had at least one efficacy measurement||Reduction Ratio||Standard Deviation|Mean
763580|NCT00656851|Secondary|Fasting Glucose Insulin and HOMA|fasting plasma glucose, insulin concentrations and HOMA-insulin resistance|Week 0 and 16|||mg/dL µU/mL||Standard Error|Mean
763581|NCT00656851|Secondary|Fasting Lipids and Lipoproteins|fasting serum triglycerides, LDL-, and HDL-cholesterol concentrations|Week 0 and 16|||mg/dL||Standard Error|Mean
763582|NCT00656851|Primary|Myocardial Fatty Acid Esterification|Radio-tracer (11C-palmitate) and positron emission tomography quantification of myocardial fatty acid esterification as a % of total fatty acid extraction|Weeks 0 and 16|||(% of total fatty acid extraction)||Standard Error|Mean
763583|NCT00656851|Primary|Myocardial Fatty Acid Oxidation Rate|Radio-tracer (11C-palmitate) and positron emission tomography quantification of myocardial fatty acid oxidation rate.|Weeks 0 and 16|||(nmol palmitate/g heart muscle/min||Standard Error|Mean
763584|NCT00656851|Primary|Myocardial Fatty Acid Utilization Rate|Radio-tracer (11C-palmitate) and positron emission tomography quantification of myocardial fatty acid utilization rate. The rate at which palmitate exits the blood, enters the muscle cells in the left ventricle, and is metabolized (oxidation, re-esterification).|Weeks 0 and 16|||(nmol palmitate/g heart muscle/min||Standard Error|Mean
763585|NCT00656851|Primary|Myocardial Glucose Utilization Rate Per Unit Insulin|Radio-tracer (11C-glucose) and positron emission tomography quantification of myocardial glucose utilization rate per unit of plasma insulin. Total glucose utilization rate in the left ventricle of the heart expressed per unit of the circulating plasma insulin concentration.|Weeks 0 and 16|||(nmol glucose/g heart muscle/min/µU insu||Standard Error|Mean
763586|NCT00656851|Secondary|Myocardial Contractile Function During Systole|Echocardiographic quantification of E' wall velocity during systole averaged at the lateral wall and septum|Weeks 0 and 16|||cm/sec||Standard Error|Mean
763587|NCT00656851|Secondary|Myocardial Contractile Function During Diastole|"Echocardiographic quantification of (E/A) early to late diastolic filling velocity. Aria transfer blood to the ventricles in 2 steps:
blood collected in the atria falls into the ventricles when the atrioventricular valves opens. In the left heart, the velocity at which the blood moves during this initial action is called the early or E filling velocity.
residual blood in the atria, is emptied during diastole by atrial contraction. The velocity of the blood during atrial contraction is the A (for atrial) filling velocity. These are expressed as a ratio (E/A). If A exceeds E velocity (ratio <1.0) this is a clinical marker of diastolic dysfunction. This can occur when the left ventricular wall becomes so stiff as to impair proper filling, which can lead to diastolic heart failure."|Weeks 0 and 16|||ratio||Standard Error|Mean
763678|NCT00670462|Secondary|Blood Pressure||baseline, 6, 12, 18, and 30 months||||||
763588|NCT00656851|Primary|Myocardial Glucose Utilization Rate|Radio-tracer (11C-glucose) and positron emission tomography quantification of myocardial glucose utilization rate. The rate at which glucose exits the blood, enters the muscle cells in the left ventricle, and is metabolized (ATP generation, glycolysis, glycogenolysis, or lactate production). Total glucose utilization rate in the left ventricle of the heart.|Weeks 0 and 16|||(nmol glucose/g heart muscle/min||Standard Error|Mean
763589|NCT00656916|Primary|Lung Function Non-deterioration Rate|Lung function non deterioration rate defined by change of forced expiratory volume in one second (FEV1) of < 20%. FEV1, maximal amount of air forcefully exhaled in 1 second, converted to percentage of normal, calculated from a pulmonary function test (PFT) performed at baseline and three months.|Baseline and three months|There was no analysis performed for the protocol due the low enrollment (one participant).||Percentage (FEV1|||Number
763590|NCT00656968|Primary|Number of Participants Who Had Good Drug Compliance|Good drug compliance is defined as taking equal to or more than 80% of eradication medicines|one month after finishing test therapy|||participants|||Number
763591|NCT00656968|Primary|Number of Participants in Which H. Pylori Was Eradicated|Evaluate eradication outcome by endoscopy urease test and histology or urea breath test|one month after finishing study drugs|||participants|||Number
763592|NCT00657020|Secondary|Mean Percentage of Correct Responses During DIA Task|Mean percentage of correct responses during DIA task was determined.|Approximately 2 hours post dose administration|Number of subjects with complete imaging data on both treatments (nicotine and placebo)||Percentage of responses correct||Standard Deviation|Mean
763593|NCT00657020|Secondary|Mean Response Time for Correct Responses During DIA Task|"DIA task comprised of three conditions: i) Sustained visual attention wherein participant responded to letter s every time it appeared in a continuous stream of letters on a screen; ii) Sustained auditory attention wherein participant responded to the number 8 each time in appeared in a continuous stream of numbers presented through headphones; iii) Divided attention task auditory and visual stimuli wherein participant responded to occurrences of s (visual) and 8 (auditory) simultaneously. Mean response time for correct responses was determined."|Approximately 2 hours post dose administration|Number of participants with complete imaging data on both treatments (nicotine and placebo).||msec||Standard Deviation|Mean
763594|NCT00657020|Secondary|Percent Mean Change in BOLD Scores During Divided Attention (DIA) Task|"BOLD fMRI signals evaluated different brain ROIs during DIA task which comprised of three conditions: i) Sustained visual attention wherein participant responded to letter s every time it appeared in a continuous stream of letters on a screen; ii) Sustained auditory attention wherein participant responded to the number 8 each time in appeared in a continuous stream of numbers presented through headphones; iii) Divided attention task auditory and visual stimuli wherein participant responded to occurrences of s (visual) and 8 (auditory) simultaneously. Brain ROIs were right and left parietal cortex, visual cortex, superior occipital cortex and right premotor cortex."|Approximately 2 hours post dose admininstration|Number of participants with complete imaging data on both treatments (nicotine and placebo).||Percentage change in BOLD signal||Standard Deviation|Mean
763595|NCT00657020|Secondary|Mean Percentage of Correct Responses During RVIP Task|Percentage of correct responses during RVIP task was determined|Approximately 2 hours post dose administration|Number of participants with complete imaging data on both treatments (nicotine and placebo).||Percentage of responses correct||Standard Deviation|Mean
763596|NCT00657020|Secondary|Mean Response Time for Correct Responses During RVIP Task|"During the RVIP task, participants responded to consecutive sequences of three odd or three even numbers by pressing the corresponding response button as quickly and accurately as possible. During a control task, participants responded to single occurrences of the number 0. Mean response time for correct responses was determined."|Approximately 2 hours post dose administration|Number of participants with complete imaging data on both treatments (nicotine and placebo).||milliseconds (msec)||Standard Deviation|Mean
763597|NCT00657020|Primary|Percent Mean Change in Blood Oxygen-level Dependent (BOLD) Scores During Rapid Visual Information Processing (RVIP) Task|In RVIP task, participant responded to consecutive sequences of three odd or three even numbers by pressing the corresponding response button as quickly and accurately as possible. During a control task, participant responded to single occurrences of the number “0”. BOLD fMRI signals evaluated different brain regions of interest (ROI) during RVIP task. Brain ROIs identified were right and left anterior insula, anterior putamen, parietal cortex, premotor cortex, visual cortex, dorsal anterior cingulate cortex, substantia nigra and thalamus.|Approximately 2 hours post dose administration|Number of participants with complete imaging data on both treatments (nicotine and placebo).||Percentage change in BOLD signal||Standard Deviation|Mean
763598|NCT00657046|Post-Hoc|Number Patients With Hypotension Induced Early Termination of Dialysis Procedure||6 weeks|Patients had to have at least one post baseline visit (visit 8 and beyond).||participants|||Number
763599|NCT00657046|Other Pre-specified|Change in Systolic Blood Pressure From Pre-dialysis to Post-dialysis|"Change from baseline (visits 2-7) to end of study (HD visits 14-19) in the drop in systolic blood pressure from pre-hemodialysis to 5 minutes post-hemodialysis.
The baseline value was the arithmetic average of the values collected at each of the six baseline visits (visits 2-7). The on treatment value was defined as the average of the values collected at each of the last six treatment visits (visits 14-19)."|6 weeks|Patients must have completed visits in the visit 14-19 timeframe.||mmHg||Standard Deviation|Mean
763600|NCT00657046|Post-Hoc|Systolic Blood Pressure Difference Between Pre-Hemodialysis and Nadir|Change from baseline to end of study (HD visits 14-19) in systolic blood pressure difference between pre-hemodialysis and nadir.|6 weeks|Patients must have completed visits in the visit 14-19 timeframe. One droxidopa 400 mg patient did not have the required nadir blood pressure information for visits 14-19 and was excluded from the analysis.||mmHg||Standard Deviation|Mean
763601|NCT00657046|Secondary|Change in the Multidimensional Fatigue Inventory (MFI-20)|"Fatigue will be measured by the general fatigue domain (items 1, 5, 12 and 16) of MFI-20 and will be summarized by treatment group and treatment period. The scores per item run from 1 to 5. A higher score indicates more fatigue. Therefore, the items indicative for fatigue need to be recoded (1=5, 2=4, 3=3, 4=2, 5=1). This concerns item: 5 and 16. A total score is calculated by summation of the scores of the individual items. Scores can range from the minimum of 4 to the maximum of 20.
The value at baseline (visit 7) will be subtracted from the value on treatment (visit 19 or visit 13 if visit 19 is not available)."|6 weeks|Patients must have completed at least visit 14. Three placebo patients did not complete their Multidimensional Fatigue Inventory during this visit.||units on a scale||Standard Deviation|Mean
763602|NCT00657046|Secondary|Daily Symptoms Associated With Hemodialysis|"The Daily symptoms associated with hemodialysis score is the sum of an 8 question scale (each rated 0 [asymptomatic] to 4 [severe]). The questions look at fatigability, malaise/weakness, physical disturbance on standing, coldness of limbs, dizziness/lightheadedness, dizziness on standing, general bad feeling, and sleep disorders and asks how each of these items affected the patients daily activities on that day.
The outcome looks at the difference between the average baseline score (visits 2-7) and the average on-treatment scores (visits 14-19). The baseline value will be the arithmetic average of the values collected at each of the six baseline visits (visits 2-7). The on treatment value will be defined as the average of the values collected at each of the last six treatment visits (visits 14-19)."|6 weeks|Patients must have completed visits in the visit 14-19 timeframe. Three placebo patients and one droxidopa 600mg patient did not complete their Daily Symptoms Assessments during these visits.||units on a scale||Standard Deviation|Mean
763603|NCT00657046|Secondary|Change in the Hypotension-induced Symptom Severity Score|"The hypotension-induced symptom severity score is the sum of a 6 question scale (each rated 0 [asymptomatic] to 4 [severe]). The questions look at cramps, dizziness, headache, nausea, itchiness, and restless legs syndrome experienced during dialysis.
The outcome looks at the difference between the average baseline score (visits 2-7) and the average on-treatment scores (visits 14-19). The baseline value will be the arithmetic average of the values collected at each of the six baseline visits (visits 2-7). The on treatment value will be defined as the average of the values collected at each of the last six treatment visits (visits 14-19)."|6 weeks|Patients must have completed visits in the visit 14-19 time frame.||units on a scale||Standard Deviation|Mean
763604|NCT00657046|Secondary|Change in the Number of Hypotension-induced Interventions During Hemodialysis (HD) Sessions;|Evaluate the efficacy of droxidopa as measured by change in the number of hypotension-induced interventions during hemodialysis (HD) sessions between baseline (visits 2-7) and treatment (visits 14-19). The baseline value will be the arithmetic average of the values collected at each of the six baseline visits (visits 2-7). The on treatment value will be defined as the average of the values collected at each of the last six treatment visits (visits 14-19).|6 weeks|Patients must have completed visits in the visit 14-19 timeframe.||average interventions per session||Standard Deviation|Mean
763605|NCT00657046|Secondary|Change in Average Mean Nadir Systolic Blood Pressures During Hemodialysis;|Change between baseline (visits 2-7) and treatment (visits 14-19) in average mean nadir systolic blood pressures during hemodialysis. The baseline value will be the arithmetic average of the values collected at each of the six baseline visits (visits 2-7). The on treatment value will be defined as the average of the values collected at each of the last six treatment visits (visits 14-19).|6 weeks|Patients must have blood pressure data from baseline and from visits 14-19. One droxidopa 400mg patient did not have blood pressure data for visit 14-19 and was excluded from the analysis.||mmHg||Standard Deviation|Mean
763606|NCT00657046|Primary|Change in Average Mean Arterial Blood Pressure During Hemodialysis|"Change between average baseline (visits 2-7) mean arterial blood pressure during hemodialysis and average treatment (visits 14-19) mean arterial blood pressure during hemodialysis.
The calculation of MAP was based on the systolic (SBP) and diastolic (DBP) blood pressure measurements taken during each valid HD session, using the traditional formula:
MAP = (SBP+2*DBP)/3 for each time-point. The mean of the intradialytic measurements was calculated for each valid HD session, and these daily mean values were averaged across the visits within each period."|6 weeks|Patients must have blood pressure data from baseline and from visits 14-19. One droxidopa 400mg patient did not have blood pressure data for visit 14-19 and was excluded from the analysis.||mmHg||Standard Deviation|Mean
763607|NCT00657150|Secondary|Laboratory Analyses|Frequency of patients with possible clinically significant abnormalities.|First administration to end of study|Treated patients||participants|||Number
763608|NCT00657150|Secondary|Volume of Blood Loss|Volume of blood loss for treated and operated patients during surgery.|Day 1|Treated and operated patients||mL||Standard Deviation|Mean
763609|NCT00657150|Secondary|Blood Transfusion|Number of treated and operated patients with required blood transfusion on day of surgery.|Day 1|Treated and operated patients||participants|||Number
763610|NCT00657150|Secondary|Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period|"Major bleeding events were defined as
fatal
clinically overt associated with loss of haemoglobin >=20g/L in excess of what was expected
clinically overt leading to the transfusion of >=2 units packed cells or whole blood in excess of what was expected
symptomatic retroperitoneal, intracranial, intraocular or intraspinal
requiring treatment cessation
leading to re-operation
Clinically-relevant was defined as
spontaneous skin hematoma >=25 cm²
wound hematoma >=100 cm²
spontaneous nose bleed >5 min
macroscopic hematuria spontaneous or >24 hours if associated with an intervention
spontaneous rectal bleeding
gingival bleeding >5 min
any other bleeding event considered clinically relevant by the investigator
Any bleeding events were defined as major, clinically-relevant and minor bleeding events. Minor bleeding events were defined as all other bleeding events that did not fulfil the criteria from above."|28-35 days|All patients who had been randomised, had taken at least 1 dose of oral or subcutaneous trial medication.||Participants|||Number
763611|NCT00657150|Secondary|Number of Participants With Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period|Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine venography), symptomatic DVT (confirmed by venous duplex, ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy).|3 months|Patients with any data available during follow-up||Participants|||Number
763612|NCT00657150|Secondary|Number of Participants Who Died During Treatment Period|All cause death, as adjudicated by the VTE events committee|28-35 days|Full Analysis Set - op (all patients who had been randomised, had taken at least 1 dose of oral or subcutaneous trial medication or had undergone surgery (i.e. a date of surgery was reported)||Participants|||Number
763613|NCT00657150|Secondary|Number of Participants With Pulmonary Embolism During Treatment Period|Pulmonary embolism confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy, and as adjudicated by the VTE events committee|28-35 days|Full Analysis Set - op (all patients who had been randomised, had taken at least 1 dose of oral or subcutaneous trial medication or had undergone surgery (i.e. a date of surgery was reported)||Participants|||Number
767780|NCT00691054|Secondary|Number of Participants Experiencing Adverse Events||6 months|||Participants|||Count of Participants
763614|NCT00657150|Secondary|Number of Participants With Symptomatic Deep Vein Thrombosis During Treatment Period|Symptomatic Deep Vein Thrombosis, confirmed by venous duplex, ultrasound, venography or autopsy, and as adjudicated by the VTE events committee|28-35 days|Full Analysis Set - op (all patients who had been randomised, had taken at least 1 dose of oral or subcutaneous trial medication or had undergone surgery (i.e. a date of surgery was reported)||Participants|||Number
763615|NCT00657150|Secondary|Number of Participants With Total Deep Vein Thrombosis During Treatment Period|Total Deep Vein Thrombosis as adjudicated by the VTE events committee|28-35 days|Full Analysis Set-tDVT (randomised, had taken at least 1 dose of oral or subcutaneous trial medication, had undergone surgery, evaluable negative venogram for both distal and proximal DVT in both legs or positive venography in any 1 segment of 1 or both legs, or confirmed symptomatic DVT.)||Participants|||Number
763616|NCT00657150|Secondary|Number of Participants With Proximal Deep Vein Thrombosis During Treatment Period|Proximal Deep Vein Thrombosis as adjudicated by the VTE events committee|28-35 days|Full Analysis Set - pDVT (all patients who had been randomised, had taken at least 1 dose of oral or subcutaneous trial medication, had undergone surgery (i.e. a date of surgery was reported), evaluable negative venogram for proximal DVT in both legs or positive venogram in either leg or confirmed symptomatic proximal DVT)||Participants|||Number
763617|NCT00657150|Secondary|Number of Participants With Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period|Major Venous Thromboembolic Event (VTE) is defined as proximal DVT and PE, as adjudicated by the VTE events committee|28-35 days|Full Analysis Set-major (randomised, had taken at least 1 dose of oral or subcutaneous trial medication, had undergone surgery, had evaluable negative venogram for proximal DVT in both legs or a positive venogram for proximal DVT in either leg or confirmed symptomatic proximal DVT, PE or death related to VTE during the treatment period.)||Participants|||Number
763618|NCT00657150|Primary|Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period|"Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine venography), symptomatic DVT (confirmed by venous duplex, ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy).
All of these components and all deaths were centrally adjudicated by the VTE events committee, which was not aware of the treatment allocation of the patients."|28-35 days|Full Analysis Set (randomised, had taken at least 1 dose of oral or subcutaneous trial medication, had undergone surgery, had evaluable negative venogram for both distal and proximal DVT in both legs or positive venography in any 1 segment of 1 or both legs, or confirmed symptomatic DVT, PE or death during the treatment period.)||Participants|||Number
763619|NCT00669279|Secondary|Peripheral Blood Pressure||Measured at baseline, 2 weeks, and 4 weeks.||||||
763620|NCT00669279|Primary|Central Aortic Blood Pressure||Measured at baseline and 4 weeks.|||mmHg||Standard Error|Mean
763621|NCT00669318|Secondary|Time to Retreatment|Time to subsequent therapy is defined to be the time from the registration to the date subsequent therapy is initiated. The distribution of time to subsequent therapy will be estimated using the method of Kaplan-Meier|Follow-up status and retreatment information will be collected up to 5 years from registration|||months||95% Confidence Interval|Median
763622|NCT00669318|Secondary|Progression-free Survival|The progression-free survival (PFS) time is defined as the time from registration to progression or death due to any cause. The distribution of progression-free survival will be estimated using the method of Kaplan-Meier.|Follow-up status and retreatment information will be collected up to 5 years from registration|||months||95% Confidence Interval|Median
763623|NCT00669318|Secondary|Overall Survival|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.|Follow-up status and retreatment information will be collected up to 5 years from registration|||months||95% Confidence Interval|Median
763624|NCT00669318|Secondary|Overall Response Rate (Complete and Partial Response)|"A Complete Response (CR) requires the disappearance of all nodes, a non-palpable liver and spleen, no constitutional symptoms, absolute neutrophil counts >1500/uL, platelets >100000/uL, Hemoglobin >11.0 g/dL, and lymphocytes <4000/uL. A bone marrow biopsy with evidence of <30% lymphocytes and no nodules.
Patients who fulfill all criteria for a CR but have a persistent anemia, thrombocytopenia, or neutropenia related to drug toxicity will be classified as CR with incomplete marrow recovery (CRi).
A Partial Response (PR) requires a 50% reduction in nodes and liver/spleen measurements and at least two of the following: absolute neutrophil counts >1500/uL, platelets >100000/uL, Hemoglobin >11.0 g/dL, or a >50% reduction in lymphocytes.
Here we report the rate of overall response as the number of patients attaining a CR, PR, or CRi status divided by the total number of evaluable patients. The 95% CI is estimated using the binomial distribution."|Up to 3 cycles of treatment and 2 cycles of observation (up to 5 months total)|||percentage of patients||95% Confidence Interval|Number
763625|NCT00669318|Primary|Complete Response Rate|"A Complete Response (CR) requires the disappearance of all nodes, a non-palpable liver and spleen, no constitutional symptoms, absolute neutrophil counts >1500/uL, platelets >100000/uL, Hemoglobin >11.0 g/dL, and lymphocytes <4000/uL. In addition, a bone marrow biopsy with evidence of <30% lymphocytes and no nodules.
Here we report the rate of complete response as the number of patients attaining a CR status divided by the total number of evaluable patients. The 95% CI is estimated using the binomial distribution."|Up to 3 cycles of treatment and 2 cycles of observation (up to 5 months total)|||percentage of participants||95% Confidence Interval|Number
763626|NCT00669331|Other Pre-specified|Cost Effectiveness of Treating Patients With Bronchiectasis With Inhaled Mannitol|In the presence of a significant primary endpoint, these data were intended to be derived using the trial data and external information (Note as the primary objective of this study did not reach statistical significance, cost effectiveness was not collected).|52 weeks|Not collected. As the primary objective of this study did not reach statistical significance, cost effectiveness data were not collected.|||||
763627|NCT00669331|Other Pre-specified|Health Related Quality of Life (HRQL) and Quality Adjusted Life Years (QALYs) by Treatment Group Using Utility Scores From the Health Utilities Index Questionnaire|In the presence of a significant primary endpoint, these data were intended to be derived using the trial data and external information (Note as the primary objective of this study did not reach statistical significance, HRQL and QALYs were not collected).|52 weeks|No data were collected for this assessment. As the primary objective of this study did not reach statistical significance, HRQL and QALYs were not derived.|||||
763628|NCT00669331|Other Pre-specified|Health Status and Utility Scores|In the presence of a significant primary endpoint, these data were intended to be derived from the trial data and external information (Note as the primary objective of this study did not reach statistical significance, differences in health status and utility scores were not assessed)|52 weeks|No data were collected. As the primary objective of this study did not reach statistical significance, health status and utility scores were not derived.|||||
763629|NCT00669331|Other Pre-specified|Health Related Costs of Treating Patients With Bronchiectasis|In the presence of a significant primary endpoint, these data were intended to be derived using the trial data together with external information (Note as the primary objective of this study did not reach statistical significance, health related costs were not assessed)|52 weeks|No data were collected. Since the primary objective was not significant in this study, further exploration of health economic endpoints was not done.|||||
763630|NCT00669331|Secondary|• (Exploratory) Number of Hospitalizations Due to Pulmonary Exacerbations|Mean rate of hospitalisations (number/year) summarised and analysed to take account of differing follow-up times.|52 weeks|||hospitalisations/year||95% Confidence Interval|Mean
763631|NCT00669331|Secondary|Safety Profile - Hematology|hematology assessed as clinically significant abnormal FBC (Full Blood count) at any point post baseline.|52 weeks|||participants|||Number
763632|NCT00669331|Secondary|Safety Profile - Clinical Chemistry|Clinical chemistry was assessed as clinically significant abnormal liver function test and clinically significant abnormal urea/electrolyte test at any point post baseline.|52 weeks|||participants|||Number
763633|NCT00669331|Secondary|Safety Profile - Sputum Microbiology|sputum microbiology assessed as the presence of abnormal flora in sputum sample taken at any post baseline visit|52 weeks|||participants|||Number
763634|NCT00669331|Secondary|Lung Function - Change in FEF25-75 (Forced Expiratory Flow Rate Averaged Over 25th -75th Percentile of FVC)||52 weeks|Randomised and treated with at least one post-baseline spirometry assessment||mL/s||95% Confidence Interval|Least Squares Mean
763635|NCT00669331|Secondary|Lung Function - Change in FEV1/FVC|FEV1 expressed as a ratio of FVC. Endpoint is expressed as a percentage ie FEV1/FVC*100|52 weeks|Randomised and treated with at least one post-baseline spirometry assessment||ratio (expressed as a %)||95% Confidence Interval|Least Squares Mean
763636|NCT00669331|Secondary|Lung Function - Change in FVC (Forced Vital Capacity)||52 weeks|Randomised and treated with at least one post-baseline spirometry assessment||mL||95% Confidence Interval|Least Squares Mean
763637|NCT00669331|Secondary|Lung Function - Change in FEV1 (Forced Expiratory Volume in One Second)||52 weeks|Randomised and treated with at least one post-baseline spirometry assessment||mL||95% Confidence Interval|Least Squares Mean
763638|NCT00669331|Secondary|Daytime Sleepiness Scores|Epworth Sleepiness Scale (ESS) score was calculated as the sum of scores for each of eight individual questions, such that a total score of zero represents no daytime sleepiness, and a total score of 24 represents the maximum degree of daytime sleepiness. Measured at baseline, 6 weeks, 16 weeks, 28 weeks, 40 weeks, 52 weeks|52 weeks|||units on a scale||Standard Deviation|Mean
763639|NCT00669331|Secondary|Sputum Volume|24 hour sputum weight, measured at baseline, week 6, week 16, week 28, week 40, week 52|52 weeks|||g||Standard Deviation|Mean
763640|NCT00669331|Secondary|Duration of Graded Exacerbations|Duration of graded exacerbations is defined as the number of days with graded PE within one treatment year. Mean days estimated via negative binomial model with treatment, region and baseline pulmonary exacerbation rate as predictors, with log of follow-up time as the offset variable|52 weeks|Randomised and treated||Days with GPE||95% Confidence Interval|Mean
763641|NCT00669331|Secondary|Time to First Graded Exacerbation|Time to first graded exacerbation is defined as the duration (in months) from the randomisation date to the start of the first reported graded PE during the on-treatment period. Patients without reported graded PE event will be censored at the last participation.|52 weeks|Randomised and treated||months||95% Confidence Interval|Median
763642|NCT00669331|Secondary|Antibiotic Use Prescribed for Treated Pulmonary Exacerbations|Rate of antibiotic treated graded pulmonary exacerbations, using the same definition of a graded pulmonary exacerbation as the primary endpoint. A graded pulmonary exacerbation was considered to be anti-biotic treated if use of oral, IV or inhaled antibiotic use was recorded related to the GPE event.|52 weeks|Randomised and treated (referred to as ITT)||events/year|||Number
763643|NCT00669331|Secondary|Quality of Life as Measured by the St. Georges Respiratory Questionnaire (SGRQ) Total Score|The SGRQ was collected at baseline, week 6, week 16, week 28, week 40 and week 52. Change in total score was calculated from baseline. Total scores are a weighted sum across all questions. Scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status. Higher scores indicate lower quality of life. Outcome data table gives the raw mean total score at each visit.|52 weeks|Randomised and treated with one or more post-baseline SGRQ data available||units on a scale||Standard Deviation|Mean
763644|NCT00669331|Primary|Rate of Graded Pulmonary Exacerbations|A graded pulmonary exacerbation was defined as a worsening in signs and symptoms requiring a change in treatment (Center for Drug Evaluation and Research (CDER), 2007). Grade I was required 3 main signs and symptoms, Grade II 2 main signs and symptoms and Grade III 1 main and one or more minor signs and symptoms. Main signs and symptoms were increased cough, sputum volume or sputum purulence. Minor were upper respiratory tract infection, fever, increased wheezing, increased dyspnea, increase in respiratory rate, increase in cardiac frequency of >20%, and increased malaise, fatigue or lethargy. Rate is defined as the number of all GPE events observed in one treatment year|52 weeks|Randomised and Treated (referred to as the ITT population in this trial)||GPE events per year|||Number
763645|NCT00669396|Secondary|IUD Expulsion, Removal, or Perforation|patient reports IUD expulsion, removal, or perforation OR one of these events was documented at the clinic where patient received care.|6 months|||participants|||Number
763646|NCT00669396|Secondary|Infection|diagnosis and treatment for pelvic inflammatory disease|6 months|||participants|||Number
763647|NCT00669396|Secondary|Pregnancy|positive urine pregnancy test at anytime within 6 months of presenting for emergency contraception.|6 months|||participants|||Number
763648|NCT00669396|Primary|Use of an Effective Method of Contraception at 6 Months After Requesting Emergency Contraception|Use of a method of contraception with a typical efficacy rate >= to 92%. This includes combined hormonal contraception (combined oral contraceptive pills, the contraceptive patch and ring), sterilization, IUDs, Depo-provera, and contraceptive implants.|6 months|||participants|||Number
763649|NCT00669461|Secondary|Average Number of Spontaneous Bowel Movements (SBM) Per Week|Average number of spontaneous bowel movements (SBM) per week,measured at baseline, at end of 4 weeks of treatment with Lubiprostone and at 2 weeks after stopping Lubiprostone (( so measure was reported at end of week # 1-Baseline-,end of Week #5 ( after taking the lubiprostone for 4 weeks) and end of week # 7 ( end of 2 weeks after stopping the Lubiprostone)).|up to 6 weeks|Analysis was not performed for this outcome measure secondary to the small sample size ( one patient.|||||
763650|NCT00669461|Primary|Average Bristol Stool Form Scale (BSFS) at Baseline, End of 4 Weeks and End of 6 Weeks|The average BSFS will be determined at baseline (prior to the start lubiprostone) and compared with average rating of BSFS at end of the 4 weeks of treatment with Lubiprostone and at end of 2 weeks after stopping the Lubiprostone. BSFS is scale between 1-7, it measured the shape of the stool. BSFS is a scale between 1-7, where 1 correlates with the firmest stool and 7 correlates with entirely liquid stool. Measure was reported at end of week #1-Baseline-,end of Week #5 ( after taking the lubiprostone for 4 weeks) and end of week # 7 ( end of 2 weeks after stopping the Lubiprostone).|up to 6 weeks|Analysis was not performed for this outcome measure secondary to the small sample size ( one patient)|||||
763651|NCT00669539|Primary|Mean Amblyopic Eye Visual Acuity Improvement With Spectacles|Acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at baseline and at 18wks resulting in a Snellen acuity score that can range from 20/16 to 20/800. The score is converted to logMAR (log of min angle of resolution) for statistical analysis, and a difference between the scores is calculated. A positive difference indicates acuity was better at 18wks than at baseline; a negative difference indicates acuity was worse at 18wks than at baseline.|Enrollment to 18 Weeks|Primary analysis includes only patients who completed the 18 week exam. No imputation was done if missed exam; analysis followed the intent to treat principle.||logMAR units||Standard Deviation|Mean
763652|NCT00669552|Primary|Number of Subjects With Positive T Wave Studies During a Coronary Intervention|Positive T wave alternans is determined by a proprietary program using ECG recordings during a stress test. The result is reported as positive, negative, or indeterminate.|During the coronary intervention, upto 2 hours|Only collected on subjects that had an intervention||participants|||Number
763653|NCT00669578|Primary|Best Overall Response Over the First 6 Cycles of Treatment|"Response evaluation:
Complete Remission (CR):
Neutrophil count between 1 to 10 x 10^9/L without peripheral blasts in blood or bone marrow.
Partial Hematologic Response/Partial Remission (PR):
Increase in neutrophil by 50% + above 10^9/L for neutropenia)
Clinical Improvement (CI):
Increase in Neutrophil count, hemoglobin, platelet count or reduction in blood/marrow blasts."|Every cycle of treatment for 6 cycles. Each cycle is 28 days.|None of the participants from the Phase I cohort were analyzed for this endpoint. All 65 Phase II participants were evaluable for this endpoint and included in the analysis.||participants|||Number
763654|NCT00669578|Secondary|Time to Response|The time to response is defined as the time from study registration to the first date at which the patient’s objective status was classified as a response (CR, PR or CI). In patients who do not achieve a response, time to response will be censored at the patient’s last evaluation date. The distribution for each of these event-time variables (duration of response and time to response) will be estimated by Kaplan-Meier curves.|Time from registration to the first date of response within twelve 28-day cycles of treatment.|None of the Phase I participants were evaluable for this endpoint. Sixty-five (65) patients were recruited for the Phase II portion. Only 9 of the 65 patients achieved a response. Thus, the median of time to response and the upper limit of 95% confidence interval are not attainable.|||||
763655|NCT00669578|Secondary|Duration of Response Time|Duration of response is defined as the date at which the patient’s objective status is first noted to be a CR, PR or CI to the date progression is documented (if one has occurred) or to the date of last follow-up(for those patients who have not progressed).|Time from response to disease progression, intolerance of study drug, or death.|None of the Phase I participants were evaluable for this endpoint. Sixty-five (65) participants were recruited for the Phase II portion. Results presented here are on the 9 Phase II patients who responded to treatment.||Months||95% Confidence Interval|Median
763656|NCT00669578|Secondary|Number of Participants With Treatment Related Adverse Events.|Adverse events (AE) that are classified as either possibly, probably, or definitely related to study treatment according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE version 3.0). The maximum grade for each type of AE will be recorded for each patient. The number of participants with grade 3 or higher adverse events at least possibly related to study treatment are reported here.|During treatment and every 6 months until 3 years from registration or progression.|None of the Phase I participants were used for this primary endpoint. All 65 Phase II participants were evaluable for this endpoint.||participants|||Number
763657|NCT00669578|Primary|Determine the Maximum Tolerated Dose of CC-4047|Starting at a dose level of 2.5 mg/d on days 1-21 in every 28 day cycle, participants were accrued in cohorts of three to assess dose limiting toxicities (DLT) and determine the maximum tolerated dose (MTD). Dose escalation at increments of 0.5 mg/d was done if no subject had a DLT (a grade 4 or higher hematologic toxicity or a grade 3 or higher febrile neutropenia or a grade 3 or higher non-hematologic toxicity) in cycle 1. Subsequent cohorts were treated until the maximum tolerated dose (MTD) was reached (dose level before that which results in a DLT in >1 of 6 subjects). Subsequent participants were treated at the MTD, those without response at the MTD after 3 cycles were lowered to the minimal efficacious dose (MED) of 0.5 mg daily. Here, we are reporting the percentage of participants in Phase I with a DLT at each dose level.|The first 28-day cycle of treatment.|None of the Phase II participants were evaluable for this endpoint. For the Phase I portion of this study, three participants were accrued at a 2.5 mg/day dose level, six at the 3.0 mg/day dose level, and three at the 3.5 mg/day dose level.||percentage of participants with DLT|||Number
763679|NCT00670462|Secondary|Change From Baseline in Energy Intake at 6 Months||Baseline and 6 months|"Waist-to-hip Ratio was assessed for all Males and Females, separately, irrespective of the intervention to which participants were randomized."||kcal/day||Standard Error|Mean
763680|NCT00670462|Secondary|Physical Activity, Energy Expenditure|change from baseline in energy expenditure at 6 months|Baseline and 6 months|"Waist-to-hip Ratio was assessed for all Males and Females, separately, irrespective of the intervention to which participants were randomized."||kcal/wk||Standard Error|Mean
763681|NCT00670462|Primary|Change in Body Weight||Baseline to18 months|"Waist-to-hip Ratio was assessed for all Males and Females, separately, irrespective of the intervention to which participants were randomized."||kg||Standard Deviation|Mean
763658|NCT00670449|Secondary|Change From Core Study Baseline in the Expanded Disability Status Scale (EDSS) Score|Disability progression was measured by the EDSS score. A trained neurologist grades the multiple sclerosis (MS) disability of the patient on a scale of 0-5 (no to severe disability) in 8 Functional Systems (FS): Pyramidal, cerebellar, brainstem, sensory, bowel and bladder, visual, cerebral (or mental), and other. The EDSS score ranges from 0-10 (normal to dead) with higher scores indicating greater disability. A 3-month confirmed disability progression was defined as a 3-month sustained increase from baseline in the EDSS score, that is, every EDSS score obtained (scheduled or unscheduled) within 3-months after the first progression met the following progression criteria: One point (1) increase from baseline in patients with baseline EDSS score from 0 to 5.0; or half a point (0.5) increase in patients with baseline EDSS score of 5.5 or above. A 6-month confirmed disability progression was defined exactly the same except that the sustained progression had to last 6 months.|Baseline to Months 12, 24, 36, 48, and end of study (up to 4 years)|Core full analysis set (FAS): All patients who were randomized in the core study and received at least 1 dose of core study drug. • The study became open-label with all patients receiving FTY720 0.5 mg/day (by 22-Feb- 2010). (approximately 22 months before study completion)||Units on a scale||Standard Deviation|Mean
763659|NCT00670449|Secondary|Percentage of Patients Free From 3-month and 6-month Confirmed Disability Progression at Their Last Expanded Disability Status Scale (EDSS) Assessment|Disability progression was measured by the EDSS score. A trained neurologist grades the multiple sclerosis (MS) disability of the patient on a scale of 0-5 (no to severe disability) in 8 Functional Systems (FS): Pyramidal, cerebellar, brainstem, sensory, bowel and bladder, visual, cerebral (or mental), and other. The EDSS score ranges from 0-10 (normal to dead) with higher scores indicating greater disability. A 3-month confirmed disability progression was defined as a 3-month sustained increase from baseline in the EDSS score, that is, every EDSS score obtained (scheduled or unscheduled) within 3-months after the first progression met the following progression criteria: One point (1) increase from baseline in patients with baseline EDSS score from 0 to 5.0; or half a point (0.5) increase in patients with baseline EDSS score of 5.5 or above. A 6-month confirmed disability progression was defined exactly the same except that the sustained progression had to last 6 months.|Baseline to the end of the study (up to 4 years)|Core full analysis set (FAS): All patients who were randomized in the core study and received at least 1 dose of core study drug. The study became open-label with all patients receiving FTY720 0.5 mg/day (by 22-Feb- 2010). (approximately 22 months before study completion)||Percentage of patients||95% Confidence Interval|Number
763660|NCT00670449|Secondary|Percentage of Patients Relapse-free at the End of the Study|Patients who did not experience any relapses confirmed by a neurologist during the study were regarded as relapse-free patients.|Baseline to the end of the study (up to 4 years)|Core full analysis set (FAS): All patients who were randomized in the core study and received at least 1 dose of core study drug. The study became open-label with all patients receiving FTY720 0.5 mg/day (by 22-Feb- 2010).(approximately 22 months before study completion)||Percentage of patients||95% Confidence Interval|Number
763661|NCT00670449|Secondary|Aggregate Annualized Relapse Rate (ARR) Based on Confirmed Relapses|The ARR was defined as the total number of relapses for all patients in the treatment arm / total number of days in the study for all patients in the treatment arm for the specific period of time × 365.25. General definition of relapse: Appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from the onset of a preceding clinical demyelinating event. The abnormality must be present for at least 24 hours and occur in the absence of fever (< 37.5°C) or infection. A relapse was to be confirmed by a neurologist trained on the Expanded Disability Status Scale (EDSS). A relapse must be accompanied by an increase of at least half a step (0.5) on the EDSS or an increase of 1 point on 2 different Functional Systems (FS) of the EDSS or 2 points on 1 of the FS (excluding Bowel/Bladder or Cerebral FS).|Months 0-6, 6-12, 12-24, 24-36, 36-48, and 48 to the end of the study (up to 4 years)|Core full analysis set (FAS): All patients who were randomized in the core study and received at least 1 dose of core study drug. The study became open-label with all patients receiving FTY720 0.5 mg/day (by 22-Feb- 2010). (approximately 22 months before study completion)||Relapses per year|||Number
763662|NCT00670449|Secondary|Percentage of Patients Free of New or Newly Enlarged T2 Weighted MRI Lesions|To ensure consistency, MRI scans were evaluated centrally at the Institute of Neurotherapeutics in Kyoto, Japan. After checking the scans for completeness and quality, all scans were analyzed by blinded readers (experienced neurologists). The number of new or newly enlarged T2 weighted MRI lesions were counted and recorded. New lesions were identified by comparing each lesion with previous scans. Lesions expanding through several slices were counted as only 1 lesion.|Months 0-3, 3-6, 6-9, 9-12, 12-18, 18-24, 24-36,36-48, and 48 to the end of the study (up to 4 years)|Core full analysis set(FAS): All patients who were randomized in the core study and received at least 1 dose of core study drug. Study became open-label with all patients receiving FTY720 0.5 mg/day. The study became open-label with all patients receiving FTY720 0.5 mg/day (by 22-Feb-2010). (approximately 22 months before study completion)||Percentage of patients|||Number
763663|NCT00670449|Primary|Percentage of Patients Free of Gd-enhanced T1 Weighted Magnetic Resonance Imaging (MRI) Lesions|To ensure consistency, MRI scans were evaluated centrally at the Institute of Neurotherapeutics in Kyoto, Japan. After checking the scans for completeness and quality, all scans were analyzed by blinded readers (experienced neurologists). The number of Gd-enhanced T1 weighted MRI lesions were counted and recorded. Lesions expanding through several slices were counted as only 1 lesion.|Months 6, 9, 12, 18, 24, 36, and 48|Core full analysis set (FAS): All patients who were randomized in the core study and received at least 1 dose of core study drug. The study became open-label with all patients receiving FTY720 0.5 mg/day (by 22-Feb- 2010). (approximately 22 months before study completion)||Percentage of patients|||Number
763664|NCT00670462|Secondary|Waist-to-hip Ratio at 30 Months||30 months|||ratio||Standard Error|Mean
763665|NCT00670462|Secondary|Waist-to-hip Ratio at 18 Months||18 months|||ratio||Standard Error|Mean
763666|NCT00670462|Secondary|Waist-to-hip Ratio at 12 Months||12 months|||ratio||Standard Error|Mean
763667|NCT00670462|Secondary|Waist-to-hip Ratio at 6 Months||6 months|||ratio||Standard Error|Mean
763668|NCT00670462|Secondary|Change From Baseline in Energy Intake at 18 Months||18 months|||kcal/day||Standard Error|Mean
763669|NCT00670462|Secondary|Change From Baseline in Energy Intake at 12months||12 months|||kcal/day||Standard Error|Mean
763689|NCT00670631|Secondary|Overall Survival Will be Compared to a Historical Control (UARK 98-026, TT2)as a Secondary Outcome.||After 204 patients have been enrolled|Data not available. Study conducted at University of Utah. Upon PI leaving Utah and coming to the University of Iowa, record NCT00670631 was transferred to Iowa by ClinicalTrials.gov staff. No research activities under NCT00670631 were conducted at Iowa. PRS staff at Iowa and Utah have corresponded and neither party (including PI) have the data.|||||
763690|NCT00670631|Primary|In Assessing Patient Safety, we Will Examine Treatment Toxicity Related Mortality and SAEs. Historical Study Results Indicate That a Mortality Rate of Greater Than 10% is Not Acceptable in This Population, Nor is an SAE Rate of Greater Than 15%.||Interim analyses for safety will be performed after 20, 100, 200, and 300 patients have been enrolled.|Data not available. Study conducted at University of Utah. Upon PI leaving Utah and coming to the University of Iowa, record NCT00670631 was transferred to Iowa by ClinicalTrials.gov staff. No research activities under NCT00670631 were conducted at Iowa. PRS staff at Iowa and Utah have corresponded and neither party (including PI) have the data.|||||
763691|NCT00670631|Primary|To Determine Whether, in Comparison to TT II, the Median EFS Can be Increased From 4.8 Years to 6.2 Years, Which Represents an Increase in Median EFS of Approximately 30%||After enrollment of 204 subjects is completed|Data not available. Study conducted at University of Utah. Upon PI leaving Utah and coming to the University of Iowa, record NCT00670631 was transferred to Iowa by ClinicalTrials.gov staff. No research activities under NCT00670631 were conducted at Iowa. PRS staff at Iowa and Utah have corresponded and neither party (including PI) have the data.|||||
763692|NCT00670709|Primary|Quantitative Electroencephalography Absolute Alpha Power.|Absolute power in the alpha frequency as measured by quantitative electroencephalography|baseline EEG|||microvolts squared||Standard Deviation|Mean
763693|NCT00670709|Primary|Quantitative Electroencephalography Absolute Delta Power.|Absolute power in the delta frequency as measured by quantitative electroencephalography|baseline- one time point|||microvolts squared||Standard Deviation|Mean
763694|NCT00670748|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|66 months and 10 days|||participants|||Number
763695|NCT00670748|Secondary|Number of Participants With In Vivo Survival of T-Cell Receptor (TCR)-Engineered Cells|Immunological monitoring using both tetramer analysis and staining for the T cell receptor (TCR). This will provide data to estimate the in vivo survival of lymphocytes derived from the infused cells.|1 month post treatment|||participants|||Number
763696|NCT00670748|Primary|Clinical Response Per the Response Evaluation Criteria in Solid Tumors (RECIST)|Response was determined by the RECIST. Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.|Approximately 3 years|||participants|||Number
763697|NCT00670800|Primary|Mu-opioid Binding Potential Measured in Right Amygdala|"Mu-opioid binding potential in right amygdala measured before and after 4 months of Metformin treatment.
Mu-opioid binding potential is measured in vivo with C11-carfentanil positron emission tomography in women with PCOS before and after 4 months of metformin treatment.
Binding Potential is measured by the ratio of Mu-opioid receptor concentration (Bmax)/Receptor radiotracer (C11-carfentanil) affinity (Kd.)
Control group was measured at baseline only."|Baseline and 4 months|||ratio||Standard Deviation|Mean
763698|NCT00670800|Primary|Mu-opioid Binding Potential Measured in Left Amygdala|"Mu-opioid binding potential in left amygdala measured before and after 4 months of Metformin treatment.
Mu-opioid binding potential is measured in vivo with C11-carfentanil positron emission tomography in women with PCOS before and after 4 months of metformin treatment.
Binding Potential is measured by the ratio of Mu-opioid receptor concentration (Bmax)/Receptor radiotracer (C11-carfentanil) affinity (Kd.)"|Baseline and after 4 months|||ratio||Standard Deviation|Mean
763699|NCT00670800|Primary|Mu-opioid Binding Potential Measured in Right Nucleus Accumbens|"Mu-opioid binding potential in right nucleus accumbens measured before and after 4 months of Metformin treatment.
Mu-opioid binding potential is measured in vivo with C11-carfentanil positron emission tomography in women with PCOS before and after 4 months of metformin treatment.
Binding Potential is measured by the ratio of Mu-opioid receptor concentration (Bmax)/Receptor radiotracer (C11-carfentanil) affinity (Kd.)
Control group was measured at baseline only."|Baseline and after 4 months|All 7 PCOS women were included, 2 controls were excluded because repeat baseline HOMA2-IR %S was <80%.||ratio||Standard Deviation|Mean
763700|NCT00670800|Primary|Mu-opioid Binding Potential Measured in Left Nucleus Accumbens|"Mu-opioid binding potential in left nucleus accumbens is measured before and after 4 months of Metformin treatment.
Mu-opioid binding potential is measured in vivo with C11-carfentanil positron emission tomography in women with PCOS before and after 4 months of metformin treatment.
Binding Potential is measured by the ratio of Mu-opioid receptor concentration (Bmax)/Receptor radiotracer (C11-carfentanil) affinity (Kd.)
Control group was measured at baseline only."|Baseline and after 4 months|All 7 PCOS women completed the protocol and were included. 5 of 7 controls were included in this analysis. 2 controls were excluded from analysis because repeat baseline OGTT showed HOMA %S of <80%.||ratio||Standard Deviation|Mean
763701|NCT00670930|Secondary|Number of Participants With Adverse Events, Serious Adverse Events and Death as an Assessment of Safety and Tolerability of 78 Weeks Therapy||78 weeks|The safety population consisted of all patients in the intent to treat (ITT) population that received at least one dose of study drug and had at least one post-baseline safety assessment.||Participants|||Number
763702|NCT00670930|Secondary|Change From Baseline in Thickness of the Lamina Reticularis Following 78 Weeks Treatment, as Assessed Biopsy Samples|The variable of change from baseline in thickness of the lamina reticularis at end of Week 78 was analyzed on sub-population such as responders and non-responders. Responders are defined as all patients having a Global Evaluation of Treatment Effectiveness (GETE) outcome of excellent or good where as non-responders are with GETE outcome of poor, moderate or worsening. GETE categories are excellent, good, moderate, poor, worsening, and missing as determined by the investigator.|Baseline, at end of week 78|Intent-to-treat (ITT) population: The ITT population consisted of all randomized patients. Patients with both baseline and end of treatment (at the end of week 78) data were only included for the analysis under each category.||micrometer(µm)||Standard Deviation|Mean
763703|NCT00670930|Secondary|Change From Baseline in Sub-epithelial CD4+ T-lymphocytes Following 78 Weeks Treatment, as Assessed Biopsy Samples|The variable of change from baseline in Sub-epithelial CD4+ T-lymphocytes at end of Week 78 was analyzed on sub-population such as responders and non-responders. Responders are defined as all patients having a Global Evaluation of Treatment Effectiveness (GETE) outcome of excellent or good where as non-responders are with GETE outcome of poor, moderate or worsening. GETE categories are excellent, good, moderate, poor, worsening, and missing as determined by the investigator.|Baseline, at end of week 78|Intent-to-treat (ITT) population: The ITT population consisted of all randomized patients. Patients with both baseline and end of treatment (at the end of week 78) data were only included for the analysis under each category.||cells/mm^2||Standard Deviation|Mean
763704|NCT00670930|Secondary|Change From Baseline in Sub-epithelial Cell Count of Mast Cells Following 78 Weeks Treatment, as Assessed Biopsy Samples|The variable of change from baseline in Sub-epithelial cell count of mast cells at end of Week 78 was analyzed on sub-population such as responders and non-responders. Responders are defined as all patients having a Global Evaluation of Treatment Effectiveness (GETE) outcome of excellent or good where as non-responders are with GETE outcome of poor, moderate or worsening. GETE categories are excellent, good, moderate, poor, worsening, and missing as determined by the investigator.|Baseline, at end of week 78|Intent-to-treat (ITT) population: The ITT population consisted of all randomized patients. Patients with both baseline and end of treatment (at the end of week 78) data were only included for the analysis under each category.||cells/mm^2||Standard Deviation|Mean
763705|NCT00670930|Primary|Change From Baseline in Total Subepithelial Eosinophils at the End of Week 78 (End of Treatment)|The primary variable of change from baseline in total epithelia eosinophils at end of Week 78 was analyzed on sub-population such as responders and non-responders. Responders are defined as all patients having a Global Evaluation of Treatment Effectiveness (GETE) outcome of excellent or good where as non-responders are with GETE outcome of poor, moderate or worsening. GETE categories are excellent, good, moderate, poor, worsening, and missing as determined by the investigator.|Baseline, at end of week 78|Intent-to-treat (ITT) population: The ITT population consisted of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization. Patients with both baseline and af end of week 78 data in each category have been reported.||cells/mm^2||Standard Deviation|Mean
763706|NCT00670956|Secondary|Survival at One-month Between Study and Control Groups.|Status of neonate survival 30 days after delivery|30 days after delivery (up to approximately 24 weeks post-enrollment)|||participants|||Number
763707|NCT00670956|Secondary|Comparison of CCAM Size in Mid-trimester Fetuses (Study/Administration vs Control/Placebo)||Baseline, Delivery (up to approximately 20 weeks post-enrollment)|Study was terminated without enrollment to control arm; therefore, no comparison was made|||||
763708|NCT00670956|Primary|Incidence of Hydrops Fetalis||Delivery, up to approximately 20 weeks post-enrollment|Only one participant was enrolled to the study before it was terminated; no participants were enrolled to the control arm||participants|||Number
763709|NCT00670982|Secondary|Progression-free Survival|Median progression free survival measured in months|3 years|Median time from registration to progression of disease||months||Full Range|Median
763710|NCT00670982|Secondary|Objective Response Rate|Objective response rate by Response Evaluation Criteria in Solid Tumors (RECIST v1.0) and assessed by computed tomography.Complete response (CR), disappearance of all target and non-target lesions; partial response (PR), >/=30% decrease in the sum of longest dimensions of target lesions; objective response rate = CR + PR.|1 year|Confirmed objective response rate||percentage of participants|||Number
763711|NCT00670982|Primary|Proportion of Patients Alive and Without Progression of Disease at 1 Year From Start of Protocol-based Therapy.|Percentage of patients on study without progression at one year after first treatment on study.The date of progression was defined as the earliest occurence of any of the following events: progressive disease by RECIST v1.0, date of initiation of new anticancer therapy, or death due to any cause. New anticancer therapy was defined as the addition or initiation of any new agent for treatment of cancer not including trastuzumab, vinorelbine or bevacizumab.|1 year|What percentage of patients were still on study and without progression at one year||percentage of participants||95% Confidence Interval|Number
763712|NCT00671060|Primary|Successful Expulsion of Fetus and Placenta Within 48 Hours||48 hours|One woman assigned to the 200μg arm was determined to be ineligible after enrollment due to a gestational age less than 14 weeks. She was not included in the analysis. One woman in the 100mcg arm was withdrawn from the study due to preeclampsia. She was included in the analysis as a failed induction.||participants|||Number
763713|NCT00671177|Secondary|Patient Satisfaction|Patient satisfaction was measured on a scale of 1 (best) to 7 (worst).|At the time of the procedure|||units on a scale||Full Range|Mean
763714|NCT00671177|Secondary|Time to Cecum||At the time of the procedure|||minutes||Standard Deviation|Mean
763715|NCT00671177|Primary|Colonoscopy Success With Minimal Sedation||At the time of the procedure|||Participants|||Count of Participants
763716|NCT00671437|Secondary|Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck||30 days after end of study treatment (approximately 1 year after start of treatment)|||participants|||Number
763717|NCT00671437|Secondary|Determine the Overall Disease Control Rate by RECIST Criteria as Assessed by CT and Clinical Examination and to Determine the TTP and the OS With Cetuximab Therapy||Every 8 weeks until death (approximately 5 years)|This was not analyzed due to the lack of evidence-based medicine showing an overall survival benefit of cetuximab monotherapy in this type of cancer.|||||
763718|NCT00671437|Secondary|Correlate the Overall Tumor Metabolic Response and Overall Anatomic Tumor Response and Clinical Examination Obtained at Baseline and After Eight Weeks of Treatment With Cetuximab to Overall Survival With Cetuximab Therapy||Every 8 weeks until death (approximately 5 years)|The small dataset precluded an adequate analysis of overall survival relationships due to varying co-variates such as post-progression therapies, ECOG PS, co-morbidities.|||||
763719|NCT00671437|Secondary|Correlate the Overall Tumor Metabolic Response and Overall Anatomic Tumor Response and Clinical Examination Obtained at Baseline and After Eight Weeks of Treatment With Cetuximab to Time to Progression (TTP) With Cetuximab Therapy|Cetuximab was continued after cycle 1 in patients with disease control(PR/SD) by CT, even if the FDG-PET/CT showed PMD. Cetuximab was discontinued after cycle 1 in patients with progression by CT.|Every 8 weeks until disease progression (up to 1 year)|||days||95% Confidence Interval|Median
763721|NCT00671437|Secondary|Correlation of Overall Tumor Metabolic Response as Assessed by FDG-PET/CT With the Anatomic Tumor Response Rate by RECIST Criteria as Assessed by CT and Clinical Examination|Agreement in treatment decision using CT and FDG-PET/CT. Agreement in treatment decision occurred when tumor response by CT and FDG-PET/CT resulted in the same decision in treatment (continue cetuximab due to disease control or stop cetuximab due to progression). Disagreement in treatment decision occurred when tumor response assessment by CT and FDG-PET/CT resulted in different treatment decisions.|After 8 weeks of treatment|||participants|||Number
763722|NCT00671437|Secondary|Correlation of Overall Tumor Metabolic Response as Assessed by FDG-PET/CT With the Anatomic Tumor Response Rate by RECIST Criteria as Assessed by CT and Clinical Examination|A generalization of McNemar’s test was used to test for concordance of response(partial, stable or progression) by CT and by FDG-PET/CT.|After 8 weeks of treatment|||participants|||Number
763723|NCT00671437|Secondary|Overall Anatomic Response to Eight Weeks of Scheduled Weekly Doses of Cetuximab as Assessed by CT Scan|Definitions of anatomic response by RECIST for CT scan included: complete response(CR)—disappearance of all target and non-target lesions and no new lesions; partial response(PR)—at least 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter, persistence of one or more non-target lesions, and no new lesions; stable disease (SD)—neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum longest diameter since the treatment started, persistence of one or more non-target lesions, and no new lesions; progressive disease(PD)—at least a 20% increase in the sum of the longest diameter of target lesions recorded since the treatment started, appearance of one or more new lesions/unequivocal progression of existing non-target lesions.|After 8 weeks of treatment|||participants|||Number
763724|NCT00671437|Secondary|Overall Tumor Metabolic Response to Eight Weeks of Scheduled Weekly Doses of Cetuximab as Assessed by FDG-PET/CT|Definitions of metabolic response by FDG-PET/CT included: complete metabolic response(CMR)—complete resolution of all metabolically active target and non-target lesions, and no new lesions; partial metabolic response(PMR)—20% or greater decrease in SUV of target lesions with or without decrease in number/size of non-target lesions, and no new lesions; progressive metabolic disease(PMD)—one or more new lesions, 20% or greater increase in SUV of target lesions and/or unequivocal increase in FDG activity of non-target lesions; and stable metabolic disease(SMD)—not qualifying as CMR, PMR, or PMD.|After 8 weeks of treatment|||participants|||Number
763725|NCT00671437|Primary|SUVmax at up to Three Target Tumor Sites as Assessed by FDG-PET/CT of Eligible Patients at Baseline and Then After Eight Weeks of Treatment With Cetuximab.|"Eight weeks of treatment is equal to one cycle of treatment.
FDG-PET/CT images were evaluated qualitatively as well as quantitatively by one of two experienced nuclear radiologists. For quantitative analysis, SUVmax within each of the metastatic tumor sites was determined within a volume of interest around the tumor using a Siemens eSoft workstation. Up to a maximum of three target lesions(>= 1.5 cm on the baseline CT) were identified as target lesions on the baseline FDG-PET. When multiple lesions were present, those having the greatest FDG uptake on the baseline FDG-PET were selected as target lesions. Lesions containing areas of necrosis were avoided. Other metabolically active lesions and lesions that were <1.5 cm on CT were considered non-target lesions. When more than one target lesion was identified, the average percentage change in SUVmax was used to determine metabolic response."|Baseline and after 8 weeks of treatment|||SUVmax||95% Confidence Interval|Mean
763726|NCT00671437|Primary|Metabolic Response of Target Lesions Assessed as the Change in Standardized Uptake Values (SUV) Max on FDG-PET/CT|FDG-PET/CT images were evaluated qualitatively as well as quantitatively by one of two experienced nuclear radiologists. For quantitative analysis, SUVmax within each of the metastatic tumor sites was determined within a volume of interest around the tumor using a Siemens eSoft workstation. Up to a maximum of three target lesions(>= 1.5 cm on the baseline CT) were identified as target lesions on the baseline FDG-PET. When multiple lesions were present, those having the greatest FDG uptake on the baseline FDG-PET were selected as target lesions. Lesions containing areas of necrosis were avoided. Other metabolically active lesions and lesions that were <1.5 cm on CT were considered non-target lesions. When more than one target lesion was identified, the average percentage change in SUVmax was used to determine metabolic response.|Baseline and after 8 weeks of treatment|||percentage of change||Full Range|Mean
763727|NCT00671502|Secondary|Adverse Event Assessment|the number of adverse events reported during the course of the study as reported by the participants|up to 21 days||||||
763728|NCT00671502|Secondary|Subject Functional Assessment Based on the Roland-Morris Disability Questionnaire (RMDQ)||up to 14 days||||||
763729|NCT00671502|Primary|Subject Rating of Pain on a 100-point Visual Analog Scale (VAS)|the scale used was from 0 to 100 mm. 0 equaled no pain and 100 equaled maximum pain.participants measure their pain before treatment and during treatment at each visit|up to 14 days|efficacy analyses based on ITT population. LOCF used to impute missing data. To detect a 14% difference between the carisoprodol and placebo treated subjects, 196 ITTsubjects per group (alpha level 0.025,power 80%).Assuming 15% dropout rate, 226 subjects per group were needed.A total of678 subjects were required to achieve 584 ITT subjects.||mm||95% Confidence Interval|Least Squares Mean
763730|NCT00671515|Secondary|Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) From Baseline to Study Endpoint|The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance. Insulin resistance is a condition in which cells fail to respond to the normal actions of the hormone insulin. Typically cutoff of HOMA-IR for identifying those with insulin resistance is 2.5.|Week 0-Week 12|||units on a scale||Standard Deviation|Mean
763731|NCT00671515|Primary|Change in Depression Symptom Severity From Baseline to Study Endpoint|Inventory of Depressive Symptoms-Clinician rated, 30 item (IDS-C30) score change from baseline to study endpoint. IDS-C30 total scores can range from 0 to 84, with higher scores indicating a worse outcome|Week 0 - Week 12|||Units on a scale||Standard Deviation|Mean
763732|NCT00671528|Secondary|Number of Days Required to Achieve Total Remission|The speed of action, measured as the number of days required to achieve total remission of all signs and symptoms of the disease.|Up to 28 days|||Days|||Number
763733|NCT00671528|Primary|Percent Improvement of Individually Measured Signs of the Disease|"Percent improvement of individually measured signs of the disease (erythema, vesiculation, scaling, pruritis) in a given target area that was chosen by the investigator was assessed objectively & quantified on a scale of 0-5 (0-absent, 5-very intense). Overall assessment reflected the changes in the disease & was carried out by the investigator.
The following scale was used:
Cure- Complete remission
> 75% reduction: Marked improvement
50-75% reduction: Moderate improvement
25-50% reduction: Slight improvement
<25% reduction: Ineffectiveness
Worsening of signs & symptoms"|Days 1 (prior to start of treatment), 8, 15, 21, and 28.|Due to lack of participant recruitment and therefore study termination, no analyses were performed.|||||
763734|NCT00671554|Secondary|Tumor Response Measured by RECIST Criteria and Progression-free Survival.|CT scans for disease assessment occurred at three month intervals. If partial or complete responses were observed confirmation scans were performed within four weeks. Patients were followed for 18 months post study completion. All three participants recieved at least one vaccine, and all participants had progression of disease prior to the 18 month followup visit.|From first vaccine to 18 months after the last injection|||participants|||Number
763735|NCT00671554|Primary|Safety as Measured by Number of Participants With Unexpected Adverse Events or Unexpected Laboratory Results.|Expected adverse events included injection site reactions, fever, chills, and arthralgias as anticipated with vaccine therapy. No unexpected or uncommon adverse events occurred such as disseminated sepsis. Clinical laboratory results on all participants were within expected ranges, including an increase in the number of IFN gamma expressing T-cells.|From first vaccine to 18 months after the last injection|||participants|||Number
763736|NCT00671606|Primary|Sentinel Node Identification Rate|Feasibility of sentinel node identification rate using intraoperative hysteroscopic injection of patent blue dye and radiocolloid for the detection of sentinel lymph nodes in patients with endometrial cancer. Sentinel node identification before and during surgery using a gamma counter to identify lymph nodes that have absorbed Tc-99m sulfur colloid. Study feasibility assessed with enrollment of 20 participants, approximately 1 year.|15-20 minute procedure prior to/during routine surgery for identifying the sentinel nodes|Analysis was per protocol; no analysis conducted due to low detection rate.|||Participants||
763737|NCT00671671|Secondary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Half-life was evaluated at last dose for Cohort A (Day 10) and Cohort B (Day 3).|Pre-morning dose, pre-evening dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post-evening dose on Day 3 for Cohort B, predose,0.5, 1, 2, 4, 8, 12, 24, 48 hrs postdose on Day 10 for Cohort A|PP analysis set. 'N' (number of participants analyzed) = participants evaluable for this measure. Results are reported for Cohort B at Day 3. Due to limited sampling, time interval over which plasma concentrations were measured after final dose was too short relative to projected t1/2. Therefore, t1/2 estimates were not calculated on Day 10.||hours||Standard Deviation|Mean
763738|NCT00671671|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)|Tmax was evaluated at first dose on Day 1 for Cohort A and B, and at last dose for Cohort A (Day 10) and Cohort B (Day 3).|Predose, 0.5, 1, 2, 6, 8, 12, 14 hrs postdose on Day 1 for Cohort A, B, pre-morning dose, pre-evening dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post-evening dose on Day 3 for Cohort B, predose,0.5, 1, 2, 4, 8, 12, 24, 48 hrs postdose on Day 10 for Cohort A|PP analysis set included all participants who took PF-00866554 and had sufficient plasma concentration data to facilitate calculation of the PK parameters. Here 'n' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.||hours||Full Range|Median
763739|NCT00671671|Secondary|Maximum Observed Plasma Concentration (Cmax)|Cmax was evaluated at first dose on Day 1 for Cohort A and B, and at last dose for Cohort A (Day 10) and Cohort B (Day 3).|Predose, 0.5, 1, 2, 6, 8, 12, 14 hrs postdose on Day 1 for Cohort A, B, pre-morning dose, pre-evening dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post-evening dose on Day 3 for Cohort B, predose,0.5, 1, 2, 4, 8, 12, 24, 48 hrs postdose on Day 10 for Cohort A|PP analysis set included all participants who took PF-00866554 and had sufficient plasma concentration data to facilitate calculation of the PK parameters. Here 'n' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.||ng/mL||Standard Deviation|Geometric Mean
763740|NCT00671671|Secondary|Plasma Concentration at The End of Dosing Interval (Ctau)|Ctau was evaluated at first dose on Day 1 for Cohort A and B, and at last dose for Cohort A (Day 10) and Cohort B (Day 3).|Predose, 0.5, 1, 2, 6, 8, 12 hours (hrs) postdose on Day 1 for Cohort A and B, pre-evening dose, 0.5, 1, 2, 4, 6, 8, 12 hrs post-evening dose on Day 3 for Cohort B, predose, 0.5, 1, 2, 4, 8, 12 hrs postdose on Day 10 for Cohort A|PP analysis set. Here 'n' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively. The Ctau on Day 1 was not necessary for interpretation of the PK data and hence was not analyzed.||ng/mL||Standard Deviation|Geometric Mean
763741|NCT00671671|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). AUC (0 - ∞) was evaluated at last dose for Cohort A (Day 10) and Cohort B (Day 3).|Pre-morning dose, pre-evening dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post-evening dose on Day 3 for Cohort B, predose,0.5, 1, 2, 4, 8, 12, 24, 48 hrs postdose on Day 10 for Cohort A|PP analysis set. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Results are reported for Cohort B at Day 3. Due to differences in sampling schedules between Cohort A and B, AUC (0 - ∞) data was not considered meaningful and hence were not analyzed on Day 10 for Cohort A.||ng*hr/mL||Standard Deviation|Geometric Mean
763742|NCT00671671|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the serum concentration time-curve from zero to the last measured concentration (AUClast). AUClast was evaluated at first dose on Day 1 for Cohort A and B, and at last dose for Cohort A (Day 10) and Cohort B (Day 3).|Predose, 0.5, 1, 2, 6, 8, 12, 14 hrs postdose on Day 1 for Cohort A, B, pre-morning dose, pre-evening dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post-evening dose on Day 3 for Cohort B, predose,0.5, 1, 2, 4, 8, 12, 24, 48 hrs postdose on Day 10 for Cohort A|PP analysis set. 'N' (number of participants analyzed) = participants evaluable for this measure. 'n' = participants evaluable for this measure at specified time points for each arm, respectively. Given the sampling schedule on Day 1 and Day 10 for 450 mg dose in Cohort A, AUClast data was not considered meaningful and hence were not analyzed.||ng*hr/mL||Standard Deviation|Geometric Mean
763743|NCT00671671|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)|Area under the concentration curve from time 0 to end of dosing interval (AUCtau), where dosing interval was 12 hours. AUCtau was evaluated at first dose on Day 1 for Cohort A and B, and at last dose for Cohort A (Day 10) and Cohort B (Day 3).|Predose, 0.5, 1, 2, 6, 8, 12 hours (hrs) postdose on Day 1 for Cohort A and B, pre-evening dose, 0.5, 1, 2, 4, 6, 8, 12 hrs post-evening dose on Day 3 for Cohort B, predose, 0.5, 1, 2, 4, 8, 12 hrs postdose on Day 10 for Cohort A|Per Protocol (PP) analysis set included all participants who took PF-00866554 and had sufficient plasma concentration data to facilitate calculation of the pharmacokinetic (PK) parameters. Here 'n' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.||nanogram*hour/milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
763744|NCT00671671|Primary|Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Nadir: Modified Analysis Set|Plasma HCV RNA levels were quantified using the Abbott RealTime HCV assay (LLOQ = 12 IU/mL). Change from baseline in plasma Log10 HCV RNA at nadir signified the maximum change observed during the study.|Baseline, Nadir (lowest HCV RNA level), assessed up to Day 11 for Cohort A and Day 4 for Cohort B|MAS: a subset of FAS which included all participants who had received complete dosage in the corresponding treatment regimen.||log10 IU/mL||Standard Deviation|Mean
763745|NCT00671671|Primary|Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Nadir: Full Analysis Set|Plasma HCV RNA levels were quantified using the Abbott RealTime HCV assay (LLOQ = 12 IU/mL). Change from baseline in plasma Log10 HCV RNA at nadir signified the maximum change observed during the study.|Baseline, Nadir (lowest HCV RNA level), assessed up to Day 11 for Cohort A and Day 4 for Cohort B|FAS included all randomized participants who took at least 1 dose of study medication and had both baseline and at least 1 valid post-baseline endpoint measurements for HCV viral load.||log10 IU/mL||Standard Deviation|Mean
763746|NCT00671671|Primary|Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Day 4 (Cohort B): Modified Analysis Set|Plasma HCV RNA levels were quantified using the Abbott RealTime HCV assay (LLOQ = 12 IU/mL). Baseline value calculated as the average of screening, Day 0 and Day 1 (0 hour) measurements. Change from baseline in plasma log10 HCV RNA was calculated for all participants after the last day of dosing (Day 4 for Cohort B).|Baseline, Day 4|MAS: a subset of FAS which included all participants who had received complete dosage in the corresponding treatment regimen.||log10 IU/mL||Standard Deviation|Mean
763747|NCT00671671|Primary|Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Day 4 (Cohort B): Full Analysis Set|Plasma HCV RNA levels were quantified using the Abbott RealTime HCV assay (LLOQ = 12 IU/mL). Baseline value calculated as an average of screening, Day 0 and Day 1 (0 hour) measurements. Change from baseline in plasma log10 HCV RNA was calculated for all participants after the last day of dosing (Day 4 for Cohort B).|Baseline, Day 4|FAS included all randomized participants who took at least 1 dose of study medication and had both baseline and at least 1 valid post-baseline endpoint measurements for HCV viral load.||log10 IU/mL||Standard Deviation|Mean
763748|NCT00671671|Primary|Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Day 11 (Cohort A): Modified Analysis Set|Plasma HCV RNA levels were quantified using the Abbott RealTime HCV assay (LLOQ = 12 IU/mL). Baseline value calculated as an average of screening, Day 0 and Day 1 (0 hour) measurements. Change from baseline in plasma log10 HCV RNA was calculated for all participants after the last day of dosing (Day 11 for Cohort A).|Baseline, Day 11|Modified Analysis Set (MAS): a subset of FAS which included all participants who had received complete dosage in the corresponding treatment regimen.||log10 IU/mL||Standard Deviation|Mean
763749|NCT00671671|Primary|Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Day 11 (Cohort A): Full Analysis Set|Plasma HCV RNA levels were quantified using the Abbott RealTime HCV assay (lower limit of quantification [LLOQ] = 12 international unit per milliliter [IU/mL]). Baseline value calculated as an average of screening, Day 0 and Day 1 (0 hour) measurements. Change from baseline in plasma log10 HCV RNA was calculated for all participants after the last day of dosing (Day 11 for Cohort A).|Baseline, Day 11|Full Analysis Set (FAS) included all randomized participants who took at least 1 dose of study medication and had both baseline and at least 1 valid post-baseline endpoint measurements for HCV viral load.||log10 IU/mL||Standard Deviation|Mean
763750|NCT00671723|Secondary|Rate of Extubation|percentage of patient who were extubated at day 7|7 days|||Participants|||Count of Participants
763751|NCT00671723|Primary|Change in the Chest X-ray Atelectasis Score|"Each CXR was assigned an atelectasis score.(*) The absence or presence of contralateral hyperinflation was marked as 0 or 1 point, respectively. The absence or presence of mediastinal shift was scored as 0 or 1, respectively. Atelectasis was scored for each lobe. A partial atelectasis of one lobe was scored as one point, whereas complete atelectasis of a lobe was marked as two points. The distinction between infiltrate and atelectasis as well as the total scoring was done by the interpreting radiologist. These results were summed for each CXR. The score range from 0 to 10 with 0 indicates no atelectasis,higher value indicates progressively more atelectasis.
*Hendriks T, de Hoog M, Lequin MH, Devos AS, and Merkus PJ: DNase and atelectasis in non-cystic fibrosis pediatric patients. Crit Care. 2005;9:R351–R356."|Baseline(Day 0) to Day 7|||units on a scale||Standard Deviation|Mean
763752|NCT00671749|Secondary|Worst Post Baseline Tolerability Assessment - Burning/Stinging|"Please Note: Tolerability Assessments were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF."|12 weeks|Safety Population (n=99)||participants|||Number
763753|NCT00671749|Secondary|Worst Post Baseline Tolerability Assessment - Dryness|"Please Note: Tolerability Assessments were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF."|12 weeks|Safety Population (n=99)||participants|||Number
763754|NCT00671749|Secondary|Worst Post Baseline Tolerability Assessment - Scaling|"Please Note: Tolerability Assessments were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF."|12 weeks|Safety Population (n=99)||participants|||Number
763755|NCT00671749|Secondary|Worst Post Baseline Tolerability Assessment - Erythema|"Please Note: Tolerability Assessments were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF."|12 weeks|Safety Population (n=99)||participants|||Number
763760|NCT00671788|Secondary|Progression-free Survival|"Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions.
CT scan or MRI is used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response."|Every other cycle for the first 6 months; every three months thereafter; and any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.|Eligible and treated participants||months||95% Confidence Interval|Median
763761|NCT00671788|Secondary|Frequency and Severity of Adverse Events as Assessed by CTCAE v3.0||Every cycle during treatment||||||
763762|NCT00671788|Primary|Tumor Response|"Complete and Partial Tumor Response by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Per RECIST v1.0 for target lesions and assessed by MRIor CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD.
CT scan or MRI is used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response."|Every other cycle for the first 6 months; every three months thereafter; and any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.|Eligible and treated participants||percentage of participants||90% Confidence Interval|Number
763763|NCT00671788|Primary|Progression-free Survival at 6 Months|"Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions.
CT scan or MRI is used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response."|Scans to assess progression were done every other cycle for the first 6 months; every three months thereafter; and any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.|||percentage of participants||90% Confidence Interval|Number
763764|NCT00671853|Secondary|Change in Hamilton Rating Scale for Anxiety (HAM-A)|The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety).Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0–56, where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe|Week 0 - Week 8|||units on a scale||Standard Deviation|Mean
763765|NCT00671853|Secondary|Change in the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Score|This assessment degree of enjoyment and satisfaction experienced by subjects in various areas of daily functioning. The minimum raw score on the Q-LES-Q-SF is 14, and the maximum score is 70 with a higher score indicating less enjoyment and satisfaction.|Week 0 - Week 8|||units on a scale||Standard Deviation|Mean
763766|NCT00671853|Secondary|Change in Clinical Global Impressions of Improvement or Severity (CGI-I or S) Score|"The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment.
1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill."|Week 0 - Week 8|||units on a scale||Standard Deviation|Mean
763767|NCT00671853|Secondary|Remission Rate (≤ 7) on Hamilton Rating Scale for Depression (HAM-D-17)|A score of 0-7 is considered to be normal. Hamilton Rating Scale total score ranges from 0-57 where higher scores are indicative of more depression. Remission is defined by the number of participants with Hamilton Rating Scale for Depression score equal to or less than 7.|Week 0 - Week 8|||Participants|||Number
763768|NCT00671853|Secondary|Response Rate (≥ 50% Improvement) on Hamilton Rating Scale for Depression (HAM-D-17)|A score of 0-7 is considered to be normal. Hamilton Rating Scale total score ranges from 0-57 where higher scores are indicative of more depression.|Week 0 - Week 8|||participants|||Number
763769|NCT00671853|Primary|Change in the 17 Item Hamilton Rating Scale for Depression (HAM-D-17) Score|A score of 0-7 is considered to be normal. Hamilton Rating Scale total score ranges from 0-57 where higher scores are indicative of more depression.|Week 0 - Week 8|||units on a scale||Standard Deviation|Mean
763770|NCT00671879|Secondary|Subject Functional Assessment Based on the Roland-Morris Disability Questionnaire (RMDQ)|Subject functional assessment based on the Roland-Morris Disability Questionnaire (RMDQ)at day 14.Subjects were asked to read a list of 24 sentences that people have used to describe themselves when they had back pain, and were asked to mark those statements that described their condition that day. The number of marked statements was added. A decrease in the number of marked statements from baseline represented improvement on the RMDQ.|baseline and day +14|Intent to Treat(ITT) population||marked statements||Standard Error|Least Squares Mean
763771|NCT00671879|Primary|Subject Rated Change Relief From Starting Backache of Pain on a 100-point Visual Analog Scale|on a visual analog scale of 0 to 100 millimeters(mm) with 0 being no pain and 100 being maximum pain By measuring the amount of pain before and during treatment done at each visit and recording the difference in mm.During treatment scores were averaged and this average was compared to the baseline value.|baseline to 14 days|intent to treat(ITT) population least square mean(LSMEAN, LSMEAN) diff vs Placebo||mm||Standard Deviation|Least Squares Mean
763772|NCT00671918|Secondary|Reverse Concordance of Blue Dye and Lymphoseek|The proportion of lymph nodes detected intraoperatively by Lymphoseek that were also detected by blue dye.|Surgery after injections of Lymphoseek and blue dye|All enrolled patients who were injected with both Lymphoseek and blue dye, who underwent surgery and had at least one lymph node detected by Lymphoseek (at ≥ 3σ count) in vivo, and for whom the tissue type (lymphatic/non-lymphatic) and pathology status (presence/absence of tumor cells) was confirmed.||Proportion of Lymph Nodes|Participants|95% Confidence Interval|Number
763773|NCT00671918|Primary|Concordance of Blue Dye and Lymphoseek|The proportion of lymph nodes detected intraoperatively by blue dye that were also detected by Lymphoseek.|Surgery after injections of Lymphoseek and blue dye|All enrolled patients who were injected with both Lymphoseek and blue dye, who underwent surgery and had at least one lymph node stained intraoperatively by blue dye, and for whom the tissue type (lymphatic/nonlymphatic) and pathology status (presence/absence of tumor cells) was confirmed.||Proportion of Lymph Nodes|Participants|95% Confidence Interval|Number
763774|NCT00671931|Primary|Motor Evoked Potential Amplitude|The primary outcome measure of the study was the participants who had Motor Evoked Potentials Amplitude significantly reduced (more than 70%)compared to the baseline.|baseline, 30 minutes|||participants|||Number
763775|NCT00671970|Secondary|Association of Biomarkers and One-year Survival - VEGFR-2|Archival tumor samples from grade IV participants were examined by immunohistochemistry (IHC) for biomarkers. The IHC score is the product of the percentage of cancer cells positive for VEGFR-2 multiplied by the overall intensity of staining, ranging from 0 to 3+. This produces a score ranging from 0 to 300.|1 year|||IHC Expression Score||Full Range|Median
763776|NCT00671970|Secondary|Association of Biomarkers and One-year Survival - Vascular Endothelial Growth Factor (VEGF)|Archival tumor samples from grade IV participants were examined by immunohistochemistry (IHC) for biomarkers. The IHC expression score is the product of the percentage of cancer cells positive for VEGF multiplied by the overall intensity of staining, ranging from 0 to 3+. This produces a score ranging from 0 to 300.|1 year|||IHC Expression Score||Full Range|Median
763777|NCT00671970|Secondary|Association of Biomarkers and One-year Survival - Phosphorylated Mitogen-activated Protein Kinase (pMAPK)|Archival tumor samples from grade IV participants were examined by immunohistochemistry for biomarkers.|1 year|Tumors from 22 GBM participants were available to undergo immunohistochemical staining to identify potential biomarkers of response or survival benefit. Six tumors had an insufficient measurement for analysis.||participants|||Number
763778|NCT00671970|Secondary|Association of Biomarkers and One-year Survival - Phosphorylated Protein Kinase B (pAKT)|Archival tumor samples from grade IV participants were examined by immunohistochemistry for biomarkers.|1 year|Tumors from 22 GBM participants were available to undergo immunohistochemical staining to identify potential biomarkers of response or survival benefit. Four tumors had an insufficient measurement for analysis.||participants|||Number
763779|NCT00671970|Secondary|Association of Biomarkers and One-year Survival - Phosphatase and Tensin Homologue (PTEN)|Archival tumor samples from grade IV participants were examined by immunohistochemistry for biomarkers.|1 year|Tumors from 22 GBM participants were available to undergo immunohistochemical staining to identify potential biomarkers of response or survival benefit. One tumor had an insufficient measurement for analysis.||participants|||Number
763780|NCT00671970|Secondary|Association of Biomarkers and One-year Survival - EGFR vIII|Archival tumor samples from grade IV participants were examined by immunohistochemistry for biomarkers.|1 year|Tumors from 22 GBM participants were available to undergo immunohistochemical staining to identify potential biomarkers of response or survival benefit.||participants|||Number
763781|NCT00671970|Secondary|Association of Biomarkers and One-year Survival - Epidermal Growth Factor (EGFR)|Archival tumor samples from grade IV participants were examined by immunohistochemistry for biomarkers.|1 year|Tumors from 22 GBM participants were available to undergo immunohistochemical staining to identify potential biomarkers of response or survival benefit. One tumor had an insufficient measurement for analysis||participants|||Number
763782|NCT00671970|Secondary|Pharmacokinetics of Erlotinib: AUC|Day 1 and Day 42 of Dosing Erlotinib in Cycle 1: Area under the Curve (ng/mL.h) (AUC) for subjects receiving 500 mg (Enzyme-Inducing Anti-epileptic Drug, EIAED) or 200 mg (non-EIAED) Erlotinib|Day 1 and 42 of Dosing Erlotinib|22 WHO Grade IV participants were available for pharmacokinetics studies of erlotinib||ng/ml.h||Full Range|Median
763783|NCT00671970|Secondary|Pharmacokinetics of Erlotinib: Cmax|Day 1 and Day 42 of Dosing Erlotinib in Cycle 1: Maximum Concentration (ng/mL) (Cmax) for subjects receiving 500 mg (Enzyme-Inducing Anti-epileptic Drug, EIAED) or 200 mg (non-EIAED) Erlotinib|Day 1 and 42 of Dosing Erlotinib|22 WHO Grade IV participants were available for pharmacokinetics studies of erlotinib||ng/ml||Full Range|Median
763784|NCT00671970|Secondary|Radiographic Response|"The number of participants with complete or partial response as determined by the following criteria:
Complete response (CR): Disappearance of all enhancing tumor on contrast enhanced MRI scan. Patient must be off steroids or only on adrenal maintenance doses.
Partial response (PR): Greater than or equal to a 50% reduction in the size (products of the largest perpendicular diameters) for all enhancing lesions. No new lesions may arise. Steroids must be stable or decreasing dose."|Patients were followed for the duration of the study, with a median follow-up of 103 weeks for grade III participants and 141.8 weeks for grade IV participants|||participants|||Number
763785|NCT00671970|Primary|6 Month Progression-free Survival|The proportion of patients alive and progression free at 6 months|6 months|||proportion of participants||95% Confidence Interval|Number
763786|NCT00672100|Secondary|Functional Outcome - Simple Shoulder Test (SST)|At baseline and again at 12 weeks subjects completed the Simple Shoulder Test. This test is a series of 12 (yes/no) questions. Participants get 1 point if they answer yes (they can perform the task) and 0 if they answer no. Total possible range is from 0-12. This has been shown to be a valid, reliable and consistent for subjects up to and including 60 years of age when similar injuries (rotator cuff dysfunction) are assessed.|Baseline, 12 weeks|||units on a scale||95% Confidence Interval|Mean
763787|NCT00672100|Secondary|"Percentage of Participants Who Considered the Analgesic Technique Helpful or Extremely Helpful"|"Participants were asked to rate the helpfulness of their infusion:
extremely harmful
harmful
neutral
not harmful, but not helpful
helpful
extremely helpful"|at 24 and 48 hours after discharge from the hospital|||percentage of participants|||Number
763788|NCT00672100|Primary|Change in Diaphragmatic Displacement From Baseline to Post-surgery|Diaphragm displacement from exhale to inhale. The baseline diaphragm measurement was obtained pre-operatively before the block was administered prior to surgery. This was again measured post-operatively before the patient's discharge from the Post-anesthesia Care Unit.|Baseline, Post anesthesia care unit (PACU) - within 8 hours|||percent change||95% Confidence Interval|Mean
763789|NCT00672100|Primary|Pain Measurements Via Numeric Pain Rating Scales (NRS)|Pain was reported via NRS ranging from 0 (no pain) to 10 (worst pain imaginable)|Discharge, 24 h, 48h, 12 weeks|||units on a scale||95% Confidence Interval|Mean
763790|NCT00672178|Primary|Number of Participants With Overall Complete and Partial Response (CR+PR)||8 weeks||||||
763796|NCT00672243|Secondary|Number of Participants Experiencing a ≥ Grade 3, Treatment-related, Non-hematologic Toxicity.|Number of participants experiencing a ≥ grade 3, treatment-related, non-hematologic toxicity.|2 years|Intent to treat (ITT)||participants|||Number
763797|NCT00672243|Secondary|Best Radiographic Response|Best radiographic response per modified Macdonald criteria. Complete response: disappearance of all enhancing tumor, no new lesions, and no steroids or only maintenance doses. Partial response: ≥ 50% reduction in the products of the perpendicular diameters of all enhancing lesions, no new lesions, & steroids must be at a stable/decreasing dose. Stable disease: does not qualify for complete or partial response or progression & is stable clinically. Progression: ≥ 25% increase in the sum of the products of perpendicular diameters of enhancing lesions, any new lesion or clinical deterioration.|2 years|Intent to treat (ITT)||participants|||Number
763798|NCT00672243|Secondary|Median Overall Survival (OS)|Time in weeks from the start of study treatment to date of death due to any cause. Patients alive at last follow-up are censored as of that follow-up date. Median OS was estimated using a Kaplan-Meier curve.|2 years|Intent to treat (ITT)||weeks||95% Confidence Interval|Median
763799|NCT00672243|Secondary|Median Progression Free Survival (PFS)|Time in weeks from the start of study treatment to the date of first progression according to Macdonald criteria, or to death due to any cause. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve. Progression based on Macdonald criteria is defined as a ≥ 25% increase in the sum of the products of perpendicular diameters of enhancing lesions; any new lesion; or clinical deterioration.|2 years|Intent to treat (ITT)||weeks||95% Confidence Interval|Median
763800|NCT00672243|Primary|6-month Progression-free Survival (PFS)|Percentage of participants surviving six months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to the Macdonald criteria, or death due to any cause. Progression based on Macdonald criteria is defined as a ≥ 25% increase in the sum of the products of perpendicular diameters of enhancing lesions; any new lesion; or clinical deterioration.|6 months|Intent to treat (ITT)||percentage of participants||95% Confidence Interval|Number
763801|NCT00672256|Primary|Signal Change in fMRI BOLD Signal Between Response Inhibition Trials and Control Trials in Presupplementary Motor Area (Pre-SMA) During Task on Satiated Day|"Percent signal change in fMRI BOLD response in pre-SMA to correctly inhibited targets (as compared to control trials) during a response inhibition task following smoking as usual.
Response inhibition trials are trials in the task in which the participant must inhibit a response (not press the button)when presented with a No-Go trial. Control trials are trials in the task in which the participant must press the button when presented with a Go trial."|12.5 minutes of fMRI scanning following smoking as usual|18 participants completed all aspects of the study. Two participants were excluded from analyses because they reported falling asleep in the scanner and one was excluded because of an incidental finding during the scan.||percentage of signal change||Standard Deviation|Mean
763802|NCT00672256|Primary|Signal Change in fMRI BOLD Signal Between Response Inhibition Trials and Control Trials in Presupplementary Motor Area (Pre-SMA) During Task on Abstinent Day|"Percent signal change in fMRI BOLD response in pre-SMA to correctly inhibited targets (as compared to control trials) during a response inhibition task following not smoking for 24 hours.
Response inhibition trials are trials in the task in which the participant must inhibit a response (not press the button)when presented with a No-Go trial. Control trials are trials in the task in which the participant must press the button when presented with a Go trial."|12.5 minutes of fMRI scanning following 24 hrs smoking abstinence|18 participants completed all aspects of the study. Two participants were excluded from analyses because they reported falling asleep in the scanner and one was excluded because of an incidental finding during the scan.||percentage of signal change||Standard Deviation|Mean
763803|NCT00672256|Primary|Signal Change in fMRI BOLD Signal Between Response Inhibition Trials and Control Trials in Right Inferior Frontal Cortex (rIFC) During Task on Abstinent Day|"Percent signal change in fMRI BOLD response in rIFC to correctly inhibited targets (as compared to control trials) during a response inhibition task following not smoking for 24 hours.
Response inhibition trials are trials in the task in which the participant must inhibit a response (not press the button)when presented with a No-Go trial. Control trials are trials in the task in which the participant must press the button when presented with a Go trial."|12.5 minutes of fMRI scanning following 24 hrs smoking abstinence|18 participants completed all aspects of the study. Two participants were excluded from analyses because they reported falling asleep in the scanner and one was excluded because of an incidental finding during the scan.||percentage of signal change||Standard Deviation|Mean
763804|NCT00672256|Primary|Signal Change in Functional Magnetic Resonance Imaging (fMRI) BOLD Signal Between Response Inhibition Trials and Control Trials in Right Inferior Frontal Cortex (rIFC) During Task on Satiated Day|"Percent signal change in fMRI BOLD response in rIFC to correctly inhibited targets (as compared to control trials) during a response inhibition task following smoking as usual.
Response inhibition trials are trials in the task in which the participant must inhibit a response (not press the button)when presented with a No-Go trial. Control trials are trials in the task in which the participant must press the button when presented with a Go trial."|12.5 minutes of fMRI scanning following smoking as usual|18 participants completed all aspects of the study. Two participants were excluded from analyses because they reported falling asleep in the scanner and one was excluded because of an incidental finding during the scan.||percentage of signal change||Standard Deviation|Mean
763805|NCT00672438|Secondary|Sedation by Patient Report|"Sedation was assessed by measuring cognitive speed and by asking participants to indicate on a 100-mm visual analog scale (VAS) how sedated they felt. This means that the scale is 100mm long where one extreme end of the scale represents 0, and 0 represents no sedation was experienced. The other extreme end of the scale represents 100, and 100 represents as much sedation as possible. Participants are asked to indicate what point on that continuum best represents their experience of sedation."|At the end of each infusion stage. 2 times total.|All participants were included for analysis.||numerical score||Inter-Quartile Range|Median
763806|NCT00672438|Secondary|Maximum Drug Disliking|"At the end of an infusion stage participants were asked, What was the maximum that you disliked the drug at any moment (VAS)? (100-mm VAS, 0 _ “not at all,” 100 _ “as much as possible”)? The VAS scale is 100mm long where one extreme end of the scale represents 0, and 0 indicates the participant did not like the drug experience. The other extreme end of the scale represents 100, and 100 indicates that the participant liked the drug experience as much as possible. Participants are asked to indicate what point on that continuum best represents the most they disliked the drug experience."|At the end of each infusion stage. 2 times total.|All participants were included for analysis.||numerical score||Inter-Quartile Range|Median
763807|NCT00672438|Secondary|Maximum Drug Liking|"At the end of an infusion stage participants were asked, What was the maximum that you liked the drug at any moment (VAS)? (100-mm VAS, 0 _ “not at all,” 100 _ “as much as possible”)? The VAS scale is 100mm long where one extreme end of the scale represents 0, and 0 indicates the participant did not like the drug experience. The other extreme end of the scale represents 100, and 100 indicates that the participant liked the drug experience as much as possible. Participants are asked to indicate what point on that continuum best represents the their experience."|At the end of each infusion stage. 2 times total.|All participants were included for analysis.||numerical score||Inter-Quartile Range|Median
763808|NCT00672438|Secondary|Average Drug Liking|"At the end of an infusion stage participants were asked, How much did you like the drug on average (100-mm VAS, 0 _ “not at all,” 100 _ “as much as possible”)? The VAS scale is 100mm long where one extreme end of the scale represents 0, and 0 indicates the participant did not like the drug experience. The other extreme end of the scale represents 100, and 100 indicates that the participant liked the drug experience as much as possible. Participants are asked to indicate what point on that continuum best represents the their experience."|At the end of each infusion stage. 2 times total.|All participants were included for analysis.||numerical score||Inter-Quartile Range|Median
763809|NCT00672438|Secondary|Maximum Pruritis|"At the end of an infusion stage participants were asked to rate the maximum severity of pruritis on a 100-mm visual analog scale (VAS) anchored by the words not at all and as much as possible. This means that the scale is 100mm long where one extreme end of the scale represents 0, and 0 represents no pruritis experienced. The other extreme end of the scale represents 100, and 100 represents as much pruritis as possible. Participants are asked to indicate what point on that continuum best represents their maximun experience of pruritis."|At the end of each infusion stage. 2 times total.|All participants were included for analysis.||numerical score||Inter-Quartile Range|Median
763810|NCT00672438|Secondary|Average Pruritis|"At the end of an infusion stage participants were asked to rate the average severity of pruritis on a 100-mm visual analog scale (VAS) anchored by the words not at all and as much as possible. This means that the scale is 100mm long where one extreme end of the scale represents 0, and 0 represents no pruritis experienced. The other extreme end of the scale represents 100, and 100 represents as much pruritis as possible. Participants are asked to indicate what point on that continuum best represents their average experience of pruritis."|At the end of each infusion stage. 2 times total.|All participants were included for analysis.||numerical score||Inter-Quartile Range|Median
763811|NCT00672438|Secondary|Maximum Nausea|"At the end of an infusion stage participants were asked to rate the maximum severity of nausea on a 100-mm visual analog scale (VAS) anchored by the words not at all and as much as possible. This means that the scale is 100mm long where one extreme end of the scale represents 0, and 0 represents no nausea experienced. The other extreme end of the scale represents 100, and 100 represents as much nausea as possible. Participants are asked to indicate what point on that continuum best represents their maximum experience of nausea."|At the end of each infusion stage. 2 times total.|All participants were included for analysis.||numerical score||Inter-Quartile Range|Median
763812|NCT00672438|Secondary|Average Nausea|"At the end of an infusion stage participants were asked to rate the average severity of nausea on a 100-mm visual analog scale (VAS) anchored by the words “not at all” and “as much as possible.” This means that the scale is 100mm long where one extreme end of the scale represents 0, and 0 represents no nausea experienced. The other extreme end of the scale represents 100, and 100 represents as much nausea as possible. Participants are asked to indicate what point on that continuum best represents their average experience."|At the end of each infusion stage. 2 times total.|All participants were included for analysis.||numerical score||Inter-Quartile Range|Median
763813|NCT00672438|Secondary|Sedation|Sedative opioid effects were assessed with the trail-making test (TMT) (Angst et al., 2004; Oswald and Roth, 1987). The TMT is a paper-and pencil test consisting of 4 different matrices listing numbers 1–90 in a 9 × 10 format. Subsequent numbers are located in neighboring rows or columns. Matrices were allocated randomly. Subjects had to connect numbers 1–90 as quickly as possible and the time to completion was recorded.|The trail making test was performed at training prior to study procedures, at baseline, and during each of the infusions.|All participants were included for analysis.||Time in seconds||Inter-Quartile Range|Median
763814|NCT00672438|Primary|Transcutaneous Partial Pressure of Carbon Dioxide|Partial pressure of transcutaneous carbon dioxide (CO2) was measured with aid of a pO2/pCO2-electrode (Perimed Inc., North Royalton, OH) mounted to the anterior chest wall.|Measured continuously throughout the study session ~ 5 hours|All participants were included for analysis.||mmHg||Inter-Quartile Range|Median
763815|NCT00672438|Primary|Respiratory Rate|Breaths per minute counted by direct observation and additionally recorded / external electronic monitoring.|Measured throughout the study session ~ 5 hours|All participants were included for analysis.||Breaths per minute||Inter-Quartile Range|Median
763831|NCT00672555|Secondary|Reoperations Needed for Treatment of Complication|"All patients were seen at the outpatients clinic at 3 weeks. Follow-up control was initiated at 1 year.
All reoperations that were done were assessed and measured."|1year|||Reoperations|||Number
763816|NCT00672438|Primary|Cold Pain Tolerance|"Time in seconds
Sensitivity to cold-pressor pain was tested by asking subjects to immerse their hand up to the wrist in ice water (1–2 C) continuously re-circulated within a 12-L container with the palm of the hand in full contact with the bottom of the container.They were asked to remove their hand from the water bath when it was no longer tolerable - reported as pain tolerance."|Participants underwent the pain testing measures at training prior to study procedures, at baseline and during each of the infusions.|All participants were included for analysis.||Seconds||Inter-Quartile Range|Median
763817|NCT00672438|Primary|Cold Pain Threshold|"Time in seconds
Sensitivity to cold-pressor pain was tested by asking subjects to immerse their hand up to the wrist in ice water (1–2 C) continuously re-circulated within a 12-L container with the palm of the hand in full contact with the bottom of the container.They were asked to indicate the onset of pain - reported as pain threshold."|Participants underwent the pain testing measures at training prior to study procedures, at baseline and during each of the infusions.|All participants were included for analysis.||Seconds||Inter-Quartile Range|Median
763818|NCT00672438|Primary|Heat Pain Threshold|"Degrees Centigrade
Heat pain was induced with a thermal sensory analyzer (TSA-II, Medoc Advanced Medical Systems, Durham, North Carolina). A thermode was placed in contact with skin at the volar forearm. Starting at a comfortable temperature, the thermode temperature was increased at a measured rate. Study participants pushed a button of a hand-held device at the onset of pain at which point the thermode immediately reduced the temperature."|Participants underwent the pain testing measures at training prior to study procedures, at baseline and during each of the infusions.|All participants were included for analysis.||degrees centigrade||Inter-Quartile Range|Median
763819|NCT00672490|Secondary|Treatment of Aggression Risk (Change From Baseline in the PANSS Supplement Aggression Risk Subscale Score to Day 28)|"The PANSS Supplemental Aggression Risk subscale score is the sum of 3 standard PANSS items – Excitement, Hostility and Depression – and 3 supplemental PANSS items related to anger – Anger, Difficulty in Delaying Gratification and Affective Lability and ranges from 6 to 42, where 6 is the best and 42 the worst score for the combined scale."|Baseline and 4 weeks|||score on a scale||Standard Deviation|Mean
763820|NCT00672490|Secondary|Treatment of Agitation (Change From Baseline in the PANSS Activation Subscale Score to Day 28)|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia and each item is rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS activation subscale score for effect on agitation and aggression is the sum of 6 PANSS individual items (ie, hostility, poor impulse control, excitement, uncooperativeness, poor rapport and tension) and ranges from 6 to 42.|Baseline and 4 weeks|||score on a scale||Standard Deviation|Mean
763821|NCT00672490|Secondary|Remission Rate (Number of Patients With Clinically Significant Remission)|"The number of patients with clinically significant remission (defined as YMRS total score ≤12) at Day 28 was calculated.
The YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania. Total score ≤12 indicates remission."|From Baseline to 4 weeks|||Participants|||Number
763822|NCT00672490|Secondary|Response Rate (Number of Patients With Clinically Response)|The number of patients with clinically response (defined as ≥50% reduction in the YMRS total score from baseline to Day 28) was calculated. The YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania, thus, a negative change (or 50% reduction) from baseline indicates a reduction (or improvement) in manic symptoms.|From Baseline to 4 weeks|||Participants|||Number
763823|NCT00672490|Secondary|Change From Baseline in the Young Mania Rating Scale (YMRS) Item 4 Score to Each Assessment|The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4 (0=normal). This analysis is for Item 4 (sleep) which ranges from 0 to 4 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Baseline and 4 weeks|||score on a scale||Standard Deviation|Mean
763824|NCT00672490|Secondary|Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score to Each Assessment(Day 28)|The MADRS is a 10-item scale that evaluates depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. Higher MADRS scores indicate higher levels of depressive symptoms. The MADRS total score is the sum of all 10 individual-item scores and ranges from 0 to 60.|Baseline and 4 weeks|||score on a scale||Standard Deviation|Mean
763825|NCT00672490|Secondary|Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score to Each Assessment (Day 28)|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia and each item is rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score is the sum of all 30 individual-item scores and ranges from 30 to 210|Baseline and 4 weeks|||units on a scale||Standard Deviation|Mean
763826|NCT00672490|Secondary|Change From Baseline in the Clinical Global Impressions for Bipolar Disorder Severity of Illness (CGI-BP-S) Score to Each Assessment (Day 28)|The CGI-BP-S scale rates the severity of the patient's illness at the time of assessment and is scored from 1 to 7 (1=normal, not ill to 7=very severely ill). Higher CGI-BP-S scores indicate greater illness severity|Baseline and 4 weeks|||score on a scale||Standard Deviation|Mean
763827|NCT00672490|Primary|Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Final Assessment (Day 28)|The YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in manic symptoms. Total score ≤12 indicates remission (13-19=minimal symptoms; 20-25=mild mania, 26-37=moderate mania, 38-60=severe mania).|Baseline and 4 weeks|Per Protocol Population||score on a scale||Standard Deviation|Mean
763828|NCT00672555|Secondary|Cosmetic Score|Patients was sent a postal questionnaire at 1 year, assessing cosmesis with the body image questionnaire adapted from Dunker et al. Cosmetic score resulting form 3 questions: worst 3; best 24.|1 year|||Units on a scale||Standard Deviation|Mean
763829|NCT00672555|Secondary|Body Image Score|Patients was sent a postal questionnaire at 1 year, assessing body image with the body image questionnaire adapted from Dunker et al. Body image score resulting form 5 questions: worst 5; best 20.|1 year|||Units on a scale||Standard Deviation|Mean
763830|NCT00672555|Secondary|Patient Overall Satisfaction With Procedure|Follow-up was initiated at 1 year. A postal questionnaire was sent to the patients with a VAS assessing overall satisfaction. Possible values were: lowest: 0; highest 10.|1 year|||Units on a scale||Standard Deviation|Mean
763832|NCT00672555|Secondary|Minor Complications (Wound Complications)|All wound complications were assessed; part of them being only very minor dehiscences or slight infections. They were assessed in the outpatients clinic at 3 Weeks and in the follow-up control initiated at 1 year. All patients suffering from a wound complication that occurred in the first year were counted.|1 year|||participants|||Number
763833|NCT00672555|Primary|Recurrence of a Pilonidal Sinus After Operation Using a Limberg-flap Procedure|At 1 year all patients were assessed. Patients with a recurrence of a pilonidal sinus were counted. The result is given as number of patients suffering from a recurrence.|1 year|"Per protocol:
All patients treated in the study period, who gave their informed consent and meet the inclusion criteria, as well did not have any reason for exclusion were enrolled prospectively"||participants|||Number
763834|NCT00672594|Primary|Change in Proliferation Indices Before and After Treatment|Pathologic changes will be described using immuno-histochemical techniques (assessment of apoptotic/proliferative indices and microvessel density (MVD)) using paraffin-embedded samples and freshly cut slides from the block which are deparaffinized and rehydrated through graded alcohol, where applicable. Antigen retrieval will be accomplished by microwaving in citrate buffer from 5 to 7 minutes for the Ki-67 and MVD analysis. Mean difference in %proliferation (Ki67 positive nuclei out of total nuclei) between pre and post treatment will be reported.|Baseline and 4 weeks|Two patients did not complete surgery, and five patients did not have adequate tissue samples, leaving 23 patients for analysis||Percentage of Ki67 positive nuclei||Standard Deviation|Mean
763835|NCT00672594|Secondary|Interstitial Fluid Pressure (IFP)|Measure Interstitial fluid pressure (IFP) pre-treatment and during treatment to indirectly measure the effect of Sunitinib malate on transcapillary transport and correlate with other biologic evidence of treatment effect.Eligible patients who sign consent will undergo a baseline transrectal ultrasound (TRUS)-guided measurement of tumor IFP. Participants will then begin treatment with daily oral Sunitinib malate with biweekly monitoring for response and toxicity. After 4 weeks of therapy, patients undergo a repeat TRUS and tumor IFP measurement. Following a 1 to 2 week wash out period, patients undergo prostatectomy with pathologic tissue collection. This will be performed as a means to evaluate whether Sunitinib malate has the ability to decrease tumor IFP, and whether this correlates with other tr|4 years|This was an optional test and no patients chose to participate.|||||
763836|NCT00672594|Secondary|Difference in Gene Expression Patterns Using Microarray Analysis|Microarray data of 21 specimens from men enrolled who have undergone a prostatectomy and study treatment were compared to data from 21 prostatectomy only specimens. We used previously developed genomic signatures to measure the deregulation of oncogenic pathways built using Bayesian Probit models for ‘metagene’ factors from a singular value decomposition of top differentially expressed genes. A Monte Carlo Markov Chain was used to generate the predicted probabilities of pathway activity in normalized samples. We predicted the activity of these pathways, leading to the generation of probability measures that have previously reflected the state of pathway activity. These probability scores are interpreted as gene expression values to describe pathway activity patterns. A probability near 0 indicates a low chance of pathway activity; a probability near 1 indicates a higher likelihood of activity. Differences (treatment – control) in mean probability for each pathway are reported.|4 years|21 patients had adequate samples for analysis.||Probability||Standard Deviation|Mean
763837|NCT00672594|Secondary|Protein Levels and Activation Status of PDGFR in Prostate Cancer Tissue.|We will perform immunohistochemistry staining on snap frozen specimens for endothelial and pericyte cell staining as previously described (42). Frozen prostate tumor biopsies are sectioned at 6μm thickness and fixed with acetone for 10 minutes. Endogenous peroxidase activity is quenched with 3% hydrogen peroxide for 15 min and then blocked with 5% normal serum. The slides are incubated with the primary antibody (1;100) overnight at 4 C°, and washed with PBS. Negative controls will be included by omission of the primary antibody. Biotinylated donkey antimouse antibody (1:1000, v/v) will be applied for 30 min at room temperature, followed by application of ABC kit (Vector Lab, Inc., Burlingame, USA). Slides are again washed in PBS and the color is developed by 5 min incubation with diaminobenzidine (DAB) solution. Slides are then counterstained with hematoxylin. Mean protein levels are presented.|4 years|Due to changes in the field, this test was not performed due to lack of relevance.|||||
763838|NCT00672594|Secondary|Change in Systemic Parameters Before and After Sunitinib Malate Treatment.|We evaluated candidate biomarkers of this pathway to predict for pharmacodynamic response to Sunitinib malate. In addition, a 7 ml plasma sample was collected at baseline and again at 4 weeks on all patients to assess possible biomarkers of response. Reported is the mean percent change in plasma concentration for each marker between 4 weeks and baseline.|Baseline and 4 weeks|17 patients had adequate measurements at both time points, were on an adequate dose, and took treatment at the correct time points.||Percent change||Standard Deviation|Mean
763839|NCT00672594|Secondary|Change in Pathologic (Microvessel Density).|Pathologic changes will be described using immuno-histochemical techniques (assessment of microvessel density (MVD)) using paraffin-embedded samples and freshly cut slides from the block which are deparaffinized and rehydrated through graded alcohol, where applicable. Antigen retrieval will be accomplished by microwaving in citrate buffer from 5 to 7 minutes for the MVD analysis. Results are reported as the difference in pre and post MVD. Units for MVD are number of CD31 cells per high powered field.|Baseline and 4 weeks|Two patients did not complete surgery, and five patients did not have adequate tissue samples, leaving 23 patients for analysis||CD31 cells/High Powered Field||Standard Deviation|Mean
763840|NCT00672594|Secondary|Number of Patients Experiencing Grade ≥4 Hematologic or Grade ≥3 Non-hematologic Toxicity|Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and were converted to version 4.0 for the purposes of ClinicalTrials.gov reporting.|4 years|||participants|||Number
763841|NCT00672594|Primary|Change in Apoptotic Indices Before and After Treatment|Pathologic changes will be described using immuno-histochemical techniques (assessment of apoptotic/proliferative indices and microvessel density (MVD)) using paraffin-embedded samples and freshly cut slides from the block which are deparaffinized and rehydrated through graded alcohol, where applicable. Antigen retrieval will be accomplished by microwaving in citrate buffer from 5 to 7 minutes for the Ki-67 and MVD analysis. Mean difference in %apoptosis (measured as %TUNEL positive cells per high powered field) between pre and post treatment will be reported.|Baseline and 4 weeks|Two patients did not complete surgery, and five patients did not have adequate tissue samples, leaving 23 patients for analysis||Percentage of TUNEL positive cells||Standard Deviation|Mean
763842|NCT00672620|Secondary|Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire|Healthcare resource utilization was assessed by the Health Economic Assessment (HEA) questionnaire, which monitors participants absenteeism from work, as well as resource use such as visits to a general practitioner, outpatient and inpatient services, hospitalization, medications, and other relevant services over the past 8 weeks.|Baseline and Week 8|Full analysis set||participants|||Number
763843|NCT00672620|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Week 8|Full analysis set with available data at Baseline; LOCF was used.||scores on a scale||Standard Error|Least Squares Mean
763844|NCT00672620|Secondary|Change From Baseline in the Clinical Global Impression Scale-Severity of Illness Scale|The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. LS means were from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Weeks 1, 2, 4, 6 and 8.|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
763845|NCT00672620|Secondary|Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56, where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. LS means are from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Weeks 1, 2, 4, 6 and 8.|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
763846|NCT00672620|Secondary|Change From Baseline in Montgomery-Åsberg Depression Rating Scale - Self-assessment (MADRS-S)|The MADRS-S is a patient-reported outcome measure based on MADRS, administered to evaluate treatment effectiveness in depression. This scale consists of 9 items assessing patients' mood, feelings of unease, sleep, appetite, ability to concentrate, initiative, emotional involvement, pessimism and zest for life. Each item is scored between 0 (best) and 3 (worst). The total score is calculated by summing the answers of the nine items, ranging between 0 and 27 (higher scores indicate increased impairment). LS means are from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Weeks 1, 4 and 8|"Full analysis set with available data at Baseline; LOCF was used. n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
763847|NCT00672620|Secondary|Clinical Global Impression Scale-Global Improvement Scale|The Clinical Global Impression - Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from an ANCOVA model with treatment and center as fixed factors and the CGI-S Baseline value as a covariate.|Baseline and Weeks 1, 2, 4, 6 and 8.|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
763848|NCT00672620|Secondary|Change From Baseline in the Montgomery Åsberg Depression Rating Scale (MADRS) Total Score|The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. LS means are from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Weeks 1, 2, 4, 6 and 8|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
763849|NCT00672620|Secondary|Percentage of Participants in MADRS Remission at Week 8|Remission is defined as a participant with a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≤10. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.|Week 8|Full analysis set; LOCF was used.||percentage of participants|||Number
763850|NCT00672620|Secondary|Percentage of Participants With a Sustained Response in HAM-D24|A sustained response is defined as a ≥ 20% decrease from Baseline in HAM-D24 total score obtained at Week 1 and sustained through Week 7 and at least 50% decrease from Baseline at Week 8.|Baseline to Week 8|Full analysis set with available data.||percentage of participants|||Number
763851|NCT00672620|Secondary|Percentage of Responders in HAM-D 24 Total Score by Study Visit|A responder is defined as a participant with a ≥50% decrease from Baseline in HAM-D24 total score. The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74, where a higher score indicates a greater depressive state.|Baseline and Weeks 1, 2, 4, 6 and 8.|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."||percentage of participants|||Number
764153|NCT00661726|Secondary|Change in Percentage of Annexin-positive Cells From Baseline to Nadir (the Follow-up Time Point With the Lowest Value)||up to 12 weeks|One of 6 enrolled patients withdrew from study after week 2 and was not used for analysis.||% of Annexin-Positive Cells||Standard Error|Mean
763852|NCT00672620|Secondary|Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Other Weeks Assessed|The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74 where a higher score indicates a greater depressive state. LS means were from an ANCOVA model with terms for treatment and center as factors and the Baseline rank value as a covariate.|Baseline and Weeks 1, 2, 4, and 6|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
763853|NCT00672620|Primary|Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Week 8|The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74 where a higher score indicates a greater depressive state. Least squares (LS) means were from an Analysis of Covariance (ANCOVA) model with terms for treatment and center as factors and the Baseline rank value as a covariate.|Baseline and Week 8|The full analysis set (FAS) included all randomized patients who received at least 1 dose of study drug and had at least 1 valid postbaseline value for assessment of primary efficacy. Last observation carried forward (LOCF) was used.||scores on a scale||Standard Error|Least Squares Mean
763854|NCT00672633|Secondary|HDL Cholesterol|High Density Lipoprotein Cholesterol|3 months|Intention to Treat||mg/dL||Standard Error|Mean
763855|NCT00672633|Secondary|LDL Cholesterol|Low Density Lipoprotein Cholesterol|3 months|||mg/dL||Standard Error|Mean
763856|NCT00672633|Primary|Fasting Triglycerides|Fasting Triglycerides|3 months|Intention to Treat||mg/dL||Standard Error|Geometric Mean
763857|NCT00672646|Secondary|VAS Pain on Jaw Movement at Rescue Intake|0 = 'No pain' 100 ='Worst pain imaginable'|at the time of first administration of rescue analgesic, up to the maximum time of 8 hours after intake of the investigational product|Only participants that took rescue medication are included in this analysis.||Units on a VAS scale||Full Range|Median
763858|NCT00672646|Secondary|VAS Pain Intensity at Rescue Intake|0 = 'No pain' 100 ='Worst pain imaginable'|at the time of first administration of rescue analgesic, up to the maximum time of 8 hours after intake of the investigational product|Only participants that took rescue medication are included in this analysis.||units on a VAS scale||Full Range|Median
763859|NCT00672646|Secondary|Time to First Meaningful Pain Relief|First meaningful pain relief is the time when the participant’s pain relief feels meaningful. The time to first meaningful pain relief will be reported by the participant using a stopwatch. Each time the watch is stopped, the participants will rate their pain intensity. Note: Participants who do not report first meaningful pain relief, and participants who report first meaningful pain relief after rescue intake, have the corresponding time censored to 8 hours.|from the start of administration of the investigational product up to the time of first administration of rescue analgesic or up to a maximum of 8 hours|||hour||Inter-Quartile Range|Median
763860|NCT00672646|Secondary|Time to First Perceptible Pain Relief|First perceptible pain relief is the time at which the participant begins to feel any pain relief at all. The time to first perceptible pain relief was reported by the participant using a stopwatch. Each time the watch is stopped, the participants will rate their pain intensity. Note: Participants who do not report first perceptible pain relief, and participants who report first perceptible pain relief after rescue intake, have the corresponding time censored to 8 hours.|from the start of administration of the investigational product up to the time of first administration of rescue analgesic or up to a maximum of 8 hours|||hour||Inter-Quartile Range|Median
763861|NCT00672646|Secondary|Pain Intensity (PI) by Using Visual Analogue Scale (VAS) (0-100 mm)|0 = 'No pain' 100 ='Worst pain imaginable' Up to 16 individual assessments were performed and contained in the derived primary outcome measure, thus not reported separately.|Immediately prior to administration of investigational product (IP). After intake of IP assessment will be made every 15 min for the first 2 h, at 2h and 30 min, 3 h and thereafter every hour up to 8 h after intake of IP.|||units on VAS scale||Full Range|Median
763862|NCT00672646|Primary|Sum of Pain Intensity Difference in Percent (SPID%)|Weighted sum of the pain intensity (PI) differences in percent for the given time frame. PI values are weighted according to the time since the previous PI assessment (or the time of administration of the investigational product for the first post-dose assessment). SPID% = elapsed since previous value, where is the PI difference in percent at assessment t. High values=good effect, low values=poor effect Pointwise assessments of pain are measured using a VAS scale (0-100 mm), as described in the secondary outcome measure (PI).|from the start of administration of the investigational product up to the time of first administration of rescue analgesic or up to a maximum of 8 hours|||percentage of pain intensity change * h||Full Range|Median
763863|NCT00672737|Primary|Experimental Heat-induced Pain - SaO2|The effect of arterial oxyhemoglobin desaturation during sleep (chronic intermittent hypoxia expressed by nadir SaO2 during polysomnography), on the change of heat-induced pain thresholds under remifentanil was estimated using a mixed linear regression model. The results were expressed by the estimated betas (95% CI), indicating how much the change in the heat pain threshold (expressed in C') under remifentanil, was altered per unit of change in the SaO2. For example, for every 1-%-absolute decrease in the nadir SaO2, the heat pain threshold will additionally increase by 0.0172 'C for every 1-mcg/mL increase in the plasma level of remifentanil.|2 to 3 weeks|Volunteers with evaluable data were included in the analysis.||['C/(mcg/mL)] /%||95% Confidence Interval|Mean
763864|NCT00672737|Primary|Experimental Cold-induced Pain - SaO2|The effect of arterial oxyhemoglobin desaturation during sleep (chronic intermittent hypoxia expressed by nadir SaO2 during polysomnography) on the change of cold-induced pain thresholds under remifentanil was estimated using a mixed linear regression model. The results were expressed by the estimated betas (95% CI), indicating how much the change in the cold pain threshold (expressed in seconds) under remifentanil, was altered per unit of change in the SaO2. For example, for every 1-%-absolute decrease in the nadir SaO2, the cold pain threshold will additionally increase by 0.9694 seconds for every 1-mcg/mL increase in the plasma level of remifentanil.|2 to 3 weeks|Volunteers with evaluable data were included in the analysis.||[sec/(mcg/mL)] /%||95% Confidence Interval|Mean
764154|NCT00661726|Secondary|Change in Percentage of Red Blood Cell (RBC) Hb Concentration From Baseline to Peak (the Follow-up Time Point With the Highest Value)||up to 12 weeks|One of 6 enrolled patients withdrew from study after week 2 and was not used for analysis.||% of RBC Hb Concentration||Standard Error|Mean
763865|NCT00672737|Primary|Experimental Heat-induced Pain - IGFBP-1|The effect of arterial oxyhemoglobin desaturation during sleep (chronic intermittent hypoxia expressed by insulin growth factor binding protein-1 (IGFBP-1), a serum hypoxia marker, on the change of heat-induced pain thresholds under remifentanil was estimated using a mixed linear regression model. The results were expressed by the estimated betas (95% CI), indicating how much the change in the heat pain threshold (expressed in C') under remifentanil, was altered per unit of change in the IGFBP-1. For example, for every 1-pg/mL increase in serum level of IGFBP-1, the heat pain threshold will additionally decrease by 0.0001 'C for every 1-mcg/mL increase in the plasma level of remifentanil.|2 to 3 weeks|Volunteers with evaluable data were included in the analysis.||['C/(mcg/mL)] /pg/mL||95% Confidence Interval|Mean
763866|NCT00672737|Primary|Experimental Cold-induced Pain - IGFBP-1|The effect of insulin growth factor binding protein-1 (IGFBP-1), a serum hypoxia marker, on the change of cold-induced pain thresholds under remifentanil was estimated using a mixed linear regression model. The results were expressed by the estimated beta (95% CI), indicating how much the change in the cold pain threshold (expressed in seconds) under remifentanil, was altered per unit of change in the IGFBP-1. For example, for every 1-pg/mL increase in the serum level of IGFBP-1, cold pain threshold will additionally increase by 0.0025 seconds for every 1-mcg/mL increase in the plasma level of remifentanil.|2 to 3 weeks|Volunteers with evaluable data were included in the analysis.||[sec/(mcg/mL)] /pg/mL||95% Confidence Interval|Mean
763867|NCT00672841|Primary|Safety and Tolerability of Preemptive Anidulafungin|reported as the Number of Adverse Events Possibly Related to Study Drug|weekly until ICU discharge|Subjects receiving at least 1 dose of anidulafungin were assessed.||events|||Number
763868|NCT00672841|Secondary|Incidence of Proven or Probable Invasive Fungal Infection (IFI)|Institution specific criteria were used to establish a diagnosis of proven or probable invasive candidiasis. Other IFIs were classified according to the European Organization for Research and Treatment of Cancer/Mycosis Study Group (EORTC/MSG) criteria. However, BDG results were not factored into the EORTC/MSG criteria.|Participants were followed until ICU discharge, an average of 17 days|4 subjects in the preemptive therapy were excluded from this analysis. These subjects were treated with empiric antifungal therapy despite repeatedly negative glucan results.||participants|||Number
763869|NCT00672841|Secondary|Validate Gene Expression Signatures Predictive of IC||Study Completion, an average of 17 days|Data was not collected for this outcome measure.|||||
763870|NCT00672841|Primary|Clinical Utility of Biweekly β-D-glucan (BDG) Testing in At-risk Intensive Care Unit (ICU) Patients.|Clinical utility was defined as β-D-glucan test performance. Biweekly βDG testing used a threshold of ≥ 60 pg/ml to indicate a positive test for invasive candidiasis. True and false positives, and true and false negatives were confirmed using a composite clinical definition of invasive candidiasis that combines physical symptom/signs and microbiology. Cases of proven/probable invasive fungal infection (IFI) were adjudicated by a single reviewer blinded to group assignment and BDG results.|Participants were followed until ICU discharge, an average of 17 days|Two study subjects in the preemptive therapy arm were excluded from the analysis of assay sensitivity and specific due to icteric serum specimens.||participants|||Number
763871|NCT00672854|Secondary|Hospital Mortality||2-year||||||
763872|NCT00672854|Secondary|Insulin Sensitivity||2-year||||||
763873|NCT00672854|Secondary|Autonomic Nervous System||2-year||||||
763874|NCT00672854|Secondary|Oxidative Stress||2-year||||||
763875|NCT00672854|Secondary|Inflammatory Markers||2-year||||||
763876|NCT00672854|Secondary|Endothelial Function||2-year||||||
763877|NCT00672854|Primary|Rate of Nosocomial Infection Rate|Culture-proven infection including: wound, drain, respiratory tract, bloodstream infection (BSI), and urinary tract infections while receiving PN and during current hospitalization after study entry|Up to 28 days post-randomization|||participants|||Number
763878|NCT00672932|Primary|Change in CSF Concentrations of Neopterin After 12 Weeks|CSF markers of immuno¬activation and inflammation after 12 weeks compared to baseline.|three months (Rollover subjects were assessed for a second baseline after the initial 12 week period)|One subject in the raltegravir group was censored when a pharmacological study showed no drug in either plasma (n=9) or CSF. Six subjects randomized to no drug later rolled over to receive raltegravir. Primary analysis treated the rollover subjects as independent and compared 14 intensified to 9 nonintensified subject experiences.||nmol/L||Standard Deviation|Mean
763879|NCT00672932|Secondary|Change From Baseline in CD8+ T Cell Co-expression of CD38 and HLA-DR|Blood CD8+ T cell activation as indicated by percentage of cells in fresh specimens coexpressing surface CD38 and human leukocyte antigen (HLA)-DR.|three months (Rollover subjects were assessed for a second baseline after the initial 12 week period)|One subject in the raltegravir group was censored when a pharmacological study showed no drug in either plasma (n=9) or CSF. Six subjects randomized to no drug later rolled over to receive raltegravir. Primary analysis treated the rollover subjects as independent and compared 14 intensified to 9 nonintensified subject experiences.||percentage of cells||Standard Deviation|Mean
763880|NCT00672958|Secondary|Health Care Resource Utilization as Assessed by the Health Economic Assessment Questionnaire|Healthcare resource utilization was assessed by the Health Economic Assessment (HEA) questionnaire, which monitors the participants absenteeism from work, as well as resource use such as visits to a general practitioner, outpatient and inpatient services, hospitalization, medications, and other relevant services over the past 8 weeks.|Baseline and Week 6|Full analysis set.||participants|||Number
763881|NCT00672958|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 6|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Week 6|Full analysis set where data were available; LOCF was used.||scores on a scale||Standard Error|Least Squares Mean
763964|NCT00660660|Secondary|Monetary Value of Work Hours Saved|The monetary value of the work hours saved was derived from questions 2,4, and 5 of the WPAI and a standard hourly compensation rate reported by the US Bureau of Labor Statistics (US$28.48 as of June 2008).|Week 4|Results based on MITT population with available data for this outcome measure.||Monetary value (US dollars)||Standard Deviation|Least Squares Mean
763882|NCT00672958|Secondary|Change From Baseline in 36-item Short-form Health Survey (SF-36) at Week 6|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The 8 health concepts are: 1. Limitation in physical activities because of health problems. 2. Limitations in usual role activities because of physical health problems. 3. Bodily pain. 4. Limitations in social activities because of physical or emotional problems. 5. General mental health (psychological distress and well-being). 6. Limitations in usual role activities because of emotional problems. 7. Vitality (energy and fatigue). 8. General health perception. Each scale ranges from 0 (best) - 100 (worst). LS means are from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Week 6|Full analysis set where Baseline SF-36 data were available; LOCF was used.||scores on a scale||Standard Error|Least Squares Mean
763883|NCT00672958|Secondary|Change From Baseline in Montgomery-Åsberg Depression Rating Scale - Self-assessment (MADRS-S)|The MADRS-S is a patient-reported outcome measure based on MADRS, administered to evaluate treatment effectiveness in depression. This scale consists of 9 items assessing patients' mood, feelings of unease, sleep, appetite, ability to concentrate, initiative, emotional involvement, pessimism and zest for life. Each item is scored between 0 (best) and 3 (worst). The total score is calculated by summing the answers of the nine items, ranging between 0 and 27 (higher scores indicate increased impairment). LS means are from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Weeks 1, 4 and 6.|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
763884|NCT00672958|Secondary|Clinical Global Impression Scale-Global Improvement Scale|The Clinical Global Impression - Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from an ANCOVA model with treatment and center as fixed factors and the CGI-S Baseline value as a covariate.|Baseline and Weeks 1, 2, 3, 4, 5 and 6.|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
763885|NCT00672958|Secondary|Change From Baseline in Clinical Global Impression Scale-Severity of Illness|The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. LS means were from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Weeks 1, 2, 3, 4, 5 and 6.|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
763886|NCT00672958|Secondary|Change From Baseline in Hamilton Anxiety Scale (HAM-A)|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56, where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Least squares means are from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Weeks 1, 2, 4 and 6.|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
763887|NCT00672958|Secondary|Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score|The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. Least square means are from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Weeks 1, 2, 3, 4, 5 and 6.|"Full analysis set. LOCF was used. n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
763888|NCT00672958|Secondary|Percentage of Participants With a Sustained Response in HAM-D24|A sustained response is defined as a ≥20% decrease from Baseline in HAM-D24 total score obtained at Week 1 and sustained through Week 5 and at least 50% decrease from Baseline at Week 6.|Baseline to Week 6|Full analysis set. Participants with missing values were classified as nonsustained responders/remitters.||percentage of participants|||Number
763889|NCT00672958|Secondary|Percentage of Participants in MADRS Remission at Week 6|Remission is defined as a participant with a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≤10. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.|Week 6|Full analysis set; LOCF was used.||percentage of participants|||Number
763890|NCT00672958|Secondary|Percentage of Responders in HAM-D24 Total Score by Study Visit|A responder is defined as a participant with a ≥50% decrease from Baseline in HAM-D24 total score. The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74, where a higher score indicates a greater depressive state.|Baseline and Weeks 1, 2, 3, 4, 5 and 6.|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."||percentage of participants|||Number
763963|NCT00660595|Primary|Change From Baseline in Positive and Negative Symptoms Scale, Excitatory Subscale (PANSS-EC) Score (Time Frame: 3 Weeks)|PANSS-EC score change was to be measured by calculating the difference between baseline score and 3 week's score. The PANSS-EC consists of 5 items (Poor IMpulse Control, Tension, Hostility, Uncooperativeness, and Excitement), each with associated descriptors. Each descriptor is rated on a 7 point scale from 1 = (absence of any symptom) to 7 = (extremely severe symptoms).|baseline and 3 weeks|||units on a scale|||Number
763891|NCT00672958|Primary|Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Other Weeks Assessed|The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74 where a higher score indicates a greater depressive state. LS means were from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Weeks 1, 2, 3, 4 and 5|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
763892|NCT00672958|Primary|Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Week 6|The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score range is from 0 to 74 where a higher score indicates a greater depressive state. Least squares (LS) means were from an Analysis of Covariance (ANCOVA) model with treatment and center as fixed factors and the baseline value as a covariate.|Baseline and Week 6|The full analysis set, which includes all randomized participants who received at least 1 dose of study drug and had at least 1 postbaseline value for assessment of primary efficacy. Last observation carried forward (LOCF) was used.||scores on a scale||Standard Error|Least Squares Mean
763893|NCT00660075|Primary|Measurement of the Area Under the Curve of Plasma Triglycerides (TG) Levels During Postprandial Period (Time 0,2,4,6,8 Hours)||At the end of the two 6-week interventions|We analyzed all the subjects involved in the study. The analysis was per protocol. We compared data from the placebo phase with the sitagliptin phase.||mmol*h/L||Standard Deviation|Mean
763894|NCT00660179|Other Pre-specified|Summary of the First Causes of Morbidity or Mortality|"Morbidity or mortality events were defined as: a) Death; b) Atrial septostomy; c) Lung transplantation; d) Initiation of intravenous (i.v.) or subcutaneous prostanoids, or; e) Other worsening of pulmonary arterial hypertension (PAH).
Other worsening of PAH was defined by the combined occurrence of all the following 3 events:
At least 15% decrease in the 6 minute walk distance from baseline, confirmed by 2 tests performed on separate days, within 2 weeks.
AND worsening of PAH symptoms including at least one of the following:
a) Increase in WHO Functional Class (WHO FC), or no change in patients in WHO FC IV at baseline; b) Appearance or worsening of signs of right heart failure that did not respond to optimized oral diuretic therapy
AND need for new treatment(s) for PAH that included the following: a) Oral or inhaled prostanoids; b) Oral phosphodiesterase inhibitors; c) Endothelin receptor antagonists (only after discontinuation of study treatment; d) i.v. diuretics"|Up to end of treatment (Up to 36 months)|All randomized patients||participants|||Number
763895|NCT00660179|Secondary|Cardiac Index at Baseline and Month 6|In a sub-study, hemodynamic variables were assessed at baseline and Month 6. If the patient had undergone a right heart catheterization during the 3 months prior to randomization, these results were to be used as baseline values, if the background therapy had not changed during the intervening period.|Baseline to month 6|All randomized patients participating in the pharmacokinetic/pharmacodynamic sub-study||L/min/m^2||Full Range|Mean
763896|NCT00660179|Secondary|Pulmonary Vascular Resistance at Baseline and Month 6|In a sub-study, hemodynamic variables were assessed at baseline and Month 6. If the patient had undergone a right heart catheterization during the 3 months prior to randomization, these results were to be used as baseline values, if the background therapy had not changed during the intervening period.|Baseline to month 6|All randomized patients participating in the pharmacokinetic/pharmacodynamic sub-study||(dyn*sec/cm^5)||Full Range|Mean
763897|NCT00660179|Secondary|Number of Patients With Improvements in World Health Organization Functional Class From Baseline to Month 6|"Class I: no limitation of usual physical activity (PA) which does not increase dyspnea, fatigue, chest pain, or presyncope.
Class II: mild limitation of PA. No discomfort at rest. Normal PA increases dyspnea, fatigue, chest pain, or presyncope.
Class III: marked limitation of PA. No discomfort at rest. Less than ordinary activity increases dyspnea, fatigue, chest pain, or presyncope.
Class IV: unable to perform any PA and who may have signs of right ventricular failure. Dyspnea and/or fatigue may be present at rest and symptoms are increased by almost any PA."|Baseline to month 6|All randomized patients excluding 1 patient in the placebo group who did not start study treatment and 2 patients in the ACT-064992 3 mg group who did not follow appropriate consent procedures and were not included in the analysis||participants|||Number
763898|NCT00660179|Secondary|Change From Baseline to Month 6 in 6-minute Walk Distance|The 6-minute walk test (6MWT) is a non-encouraged test, performed in a 30 m long flat corridor, where the patient is instructed to walk as far as possible, back and forth around two cones, with the permission to slow down, rest, or stop if needed. These guidelines were provided to all sites. For patients who had never performed a 6MWT previously, a training test was required before the qualifying tests for inclusion were performed.|Baseline to month 6|All randomized patients excluding 1 patient in the placebo group who did not start study treatment and 2 patients in the ACT-064992 3 mg group who did not follow appropriate consent procedures and were not included in the analysis||metres||Standard Deviation|Mean
763899|NCT00660179|Secondary|Time to Death Due to Any Cause up to the End of Study (Kaplan-Meier Estimate of Patients Without an Event)|Events of death due to any cause up to the end of study (EOS). The initiation of EOS procedure occurred when the target of 285 events was expected to have been achieved (30 January 2012).|Up to end of study (data presented up to month 36)|All randomized patients||percentage of participants-Kaplan Meier|||Number
763900|NCT00660179|Secondary|Time to Death Due to Any Cause up to the End of Treatment (Kaplan-Meier Estimate of Patients Without an Event)|Events of death due to any cause up to the end of treatment (plus 7 days)|Up to end of treatment (data presented up to month 36)|All randomized patients||percentage of participants-Kaplan Meier|||Number
763901|NCT00660179|Secondary|Time to Death Due to PAH or Hospitalisation for PAH up to the End of Treatment (Kaplan-Meier Estimate of Patients Without an Event)|Events of PAH or hospitalization for PAH up to the end of treatment included: death due to PAH, or onset of a treatment-emergent adverse event with a fatal outcome due to PAH occurring up to 4 weeks after the end of treatment, or hospitalisation for PAH up to the end of treatment.|Up to end of treatment (data presented up to month 36)|All randomized patients||percentage of participants-Kaplan Meier|||Number
767372|NCT00694122|Secondary|Cortisol|Mean cortisol nmol/l during NPH or glargine (Lantus) overnight visit. Hourly cortisol was determined from 22:00 to 8:00.|Overnight|Participants completing both overnight visits were included in the analysis.||nmol/l||Standard Deviation|Mean
763902|NCT00660179|Primary|Time to First Confirmed Morbidity or Mortality Event up to the End of Treatment (Kaplan-Meier Estimate of Patients Without a Morbidity or Mortality Event)|"Morbidity or mortality events were defined as: a) Death; b) Atrial septostomy; c) Lung transplantation; d) Initiation of intravenous (i.v.) or subcutaneous prostanoids, or; e) Other worsening of pulmonary arterial hypertension (PAH).
Other worsening of PAH was defined by the combined occurrence of all the following 3 events:
At least 15% decrease in the 6 minute walk distance from baseline, confirmed by 2 tests performed on separate days, within 2 weeks.
AND worsening of PAH symptoms including at least one of the following:
a) Increase in WHO Functional Class (WHO FC), or no change in patients in WHO FC IV at baseline; b) Appearance or worsening of signs of right heart failure that did not respond to optimized oral diuretic therapy
AND need for new treatment(s) for PAH that included the following: a) Oral or inhaled prostanoids; b) Oral phosphodiesterase inhibitors; c) Endothelin receptor antagonists (only after discontinuation of study treatment; d) i.v. diuretics"|Up to end of treatment (data presented up to month 36)|All randomized patients||percentage of participants-Kaplan Meier|||Number
763903|NCT00660192|Secondary|Number of Participants Satisfied With Treatment|"Number of Patients whose Patient global impression of change (PGIC) moderately or much improved- The PGIC is a 7 point scale that requires the clinician to assess how much the patient's pain has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as:
No change (or condition has gotten worse) (1) Almost the same, hardly any change at all (2) A little better, but no noticeable change (3) Somewhat better, but the change has not made any real difference (4) Moderately better, and a slight but noticeable change (5) Better and a definite improvement that has made a real and worthwhile difference (6) A great deal better and a considerable improvement that has made all the difference (7)improved
This outcome is number of patients who chose a 6 or above on the PGIC 6 weeks after treatment."|4 weeks|||participants|||Number
763904|NCT00660192|Primary|Mean Number of Days of Decrease in Pain Level Using VAS|Number of days of decreased pain (2 grades or more) on Visual Analog scale. VAS ranges from 0-10, with 0 being no pain, and 10 being worst pain.|4 weeks|||days||Standard Deviation|Mean
763905|NCT00660309|Secondary|Change From Baseline in Retinal Blood Flow After Aliskiren or Irbesartan|"Retinal blood flow was assessed using the laser Doppler technique. The blood flow in the superior temporal retinal artery in one of the eyes of each study participant was determined.
The Single dose effect of aliskiren or irbesartan was measured as the change/difference between Day 2 and baseline measurements.
The Multiple dose effect of aliskiren or irbesartan wsas measured as the change/difference between Day 15 and Day 2 measurements"|Baseline (Day 1), Day 2 and Day 15.|PD analysis set. This assessment was only conducted at sites with available Canon Laser Blood Flowmeter. The number of patients with data available included in each analysis is indicated by 'N' [Aliskiren, Irbesartan].||µL/min||Standard Deviation|Mean
763906|NCT00660309|Secondary|Change in Serum Aldosterone After Captopril, Aliskiren or Irbesartan|"The following serum aldosterone effects were assessed:
The single dose effect (SDE) for captopril, expressed as the ratio to pre-dose measurement on Day 1, = Day 1, 5 hour / Day 1 Baseline.
SDE for aliskiren and irbesartan = Day 2, 5 hour / Day 2 Baseline.
Steady state trough effect (multiple dose effect at steady state; MDE_SS) = Day 15 Baseline / Day 2 Baseline.
Steady State peak effect (maximum multiple dose effect; MDE_Max) = Day 15, 5 hour / Day 2 Baseline.
Accumulation of peak effect from single dose to multiple dose (MDE_Acc) = Day 15, 5 hour / Day 2, 5 hour."|Predose (Baseline) and 5 hours post dose on Days 1, 2 and 15.|PD analysis set. The number of patients with data available included in each analysis is indicated by 'N' [Aliskiren, Irbesartan].||ratio||95% Confidence Interval|Geometric Mean
763907|NCT00660309|Secondary|Change in Plasma Angiotensin II After Captopril, Aliskiren or Irbesartan|"The following angiotensin II effects were assessed:
The single dose effect (SDE) for captopril, expressed as the ratio to pre-dose measurement on Day 1, = Day 1, 5 hour / Day 1 Baseline.
SDE for aliskiren and irbesartan = Day 2, 5 hour / Day 2 Baseline.
Steady state trough effect (multiple dose effect at steady state; MDE_SS) = Day 15 Baseline / Day 2 Baseline.
Steady State peak effect (maximum multiple dose effect; MDE_Max) = Day 15, 5 hour / Day 2 Baseline.
Accumulation of peak effect from single dose to multiple dose (MDE_Acc) = Day 15, 5 hour / Day 2, 5 hour."|Predose (Baseline) and 5 hours post dose on Days 1, 2 and 15.|PD analysis set. The number of patients with data available included in each analysis is indicated by 'N' [Aliskiren, Irbesartan].||ratio||95% Confidence Interval|Geometric Mean
763908|NCT00660309|Secondary|Change in Plasma Angiotensin I After Captopril, Aliskiren or Irbesartan|"The following angiotensin I effects were assessed:
The single dose effect (SDE) for captopril, expressed as the ratio to pre-dose measurement on Day 1, = Day 1, 5 hour / Day 1 Baseline.
SDE for aliskiren and irbesartan = Day 2, 5 hour / Day 2 Baseline.
Steady state trough effect (multiple dose effect at steady state; MDE_SS) = Day 15 Baseline / Day 2 Baseline.
Steady State peak effect (maximum multiple dose effect; MDE_Max) = Day 15, 5 hour / Day 2 Baseline.
Accumulation of peak effect from single dose to multiple dose (MDE_Acc) = Day 15, 5 hour / Day 2, 5 hour."|Predose (Baseline) and 5 hours post dose on Days 1, 2 and 15.|PD analysis set. The number of patients with data available included in each analysis is indicated by 'N' [Aliskiren, Irbesartan].||ratio||95% Confidence Interval|Geometric Mean
763909|NCT00660309|Secondary|Change in Plasma Renin Activity (PRA) After Captopril, Aliskiren or Irbesartan|"PRA was measured by the trapping method and the following effects assessed:
The single dose effect (SDE) for captopril, expressed as the ratio to pre-dose measurement on Day 1, = Day 1, 5 hour / Day 1 baseline.
SDE for aliskiren and irbesartan = Day 2, 5 hour / Day 2 baseline.
Steady state trough effect (multiple dose effect at steady state; MDE_SS) = Day 15 baseline / Day 2 baseline.
Steady State peak effect (maximum multiple dose effect; MDE_Max) = Day 15, 5 hour / Day 2 baseline.
Accumulation of peak effect from single dose to multiple dose (MDE_Acc) = Day 15, 5 hour / Day 2, 5 hour."|Predose and 5 hours post dose on Days 1, 2 and 15.|PD analysis set. The number of patients with data available included in each analysis is indicated by 'N' [Aliskiren, Irbesartan].||ratio||95% Confidence Interval|Geometric Mean
763919|NCT00660309|Primary|Change From Baseline in Renal Plasma Flow (RPF) After a Single Dose of Aliskiren or Irbesartan|"Renal plasma flow (RPF) was measured by the clearance of para-aminohippurate (PAH) by autoanalyzer methods.
The measure of the single dose effect (SDE) for aliskiren and irbesartan was calculated as Day 2 peak - Day 2 baseline RPF. Baseline RPF was determined as the median of the -10 minute, -5 minute predose and predose (0 hour) values. Peak RPF was obtained using a moving average concept."|Day 2: Baseline (10 minutes and 5 minutes pre-treatment and 0 hours) and 1, 2, 3, 4 and 5 hours post-dose.|Pharmacodynamics (PD) analysis set consisted of all patients with available PD data and no major protocol deviations with impact on PD data.||mL/min/1.73m^2||Standard Deviation|Mean
763910|NCT00660309|Secondary|Change in Plasma Pro-renin Concentration After Captopril, Aliskiren or Irbesartan|"The following plasma pro-renin concentration effects were assessed:
The single dose effect (SDE) for captopril, expressed as the ratio to pre-dose measurement on Day 1, = Day 1, 5 hour / Day 1 Baseline.
SDE for aliskiren and irbesartan = Day 2, 5 hour / Day 2 Baseline.
Steady state trough effect (multiple dose effect at steady state; MDE_SS) = Day 15 Baseline / Day 2 Baseline.
Steady State peak effect (maximum multiple dose effect; MDE_Max) = Day 15, 5 hour / Day 2 Baseline.
Accumulation of peak effect from single dose to multiple dose (MDE_Acc) = Day 15, 5 hour / Day 2, 5 hour."|Predose (Baseline) and 5 hours post dose on Days 1, 2 and 15.|PD analysis set. The number of patients with data available included in each analysis is indicated by 'N' [Aliskiren, Irbesartan].||ratio||95% Confidence Interval|Geometric Mean
763911|NCT00660309|Secondary|Change in Plasma Renin Concentration (PRC) After Captopril, Aliskiren or Irbesartan|"The following plasma renin concentration effects were assessed:
The single dose effect (SDE) for captopril, expressed as the ratio to pre-dose measurement on Day 1, = Day 1, 5 hour / Day 1 Baseline.
SDE for aliskiren and irbesartan = Day 2, 5 hour / Day 2 Baseline.
Steady state trough effect (multiple dose effect at steady state; MDE_SS) = Day 15 Baseline / Day 2 Baseline.
Steady State peak effect (maximum multiple dose effect; MDE_Max) = Day 15, 5 hour / Day 2 Baseline.
Accumulation of peak effect from single dose to multiple dose (MDE_Acc) = Day 15, 5 hour / Day 2, 5 hour."|Predose (Baseline) and 5 hours post dose on Days 1, 2 and 15.|PD analysis set. The number of patients with data available included in each analysis is indicated by 'N' [Aliskiren, Irbesartan].||ratio||95% Confidence Interval|Geometric Mean
763912|NCT00660309|Secondary|Change From Single Dose Peak to Steady State Peak in Glomerular Filtration Rate (GFR) After Aliskiren or Irbesartan|"Glomerular filtration rate (GFR) was measured by the clearance of inulin by autoanalyzer methods.
Accumulation of peak effect from single dose to multiple dose (MDE_Acc) was calculated as Day 15 peak - Day 2 peak GFR. Peak GFR was obtained using a moving average concept."|Day 2 and Day 15: 1, 2, 3, 4 and 5 hours post-dose.|Pharmacodynamics (PD) analysis set consisted of all patients with available PD data and no major protocol deviations with impact on PD data. Analysis includes patients for whom data were available.||mL/min/1.73m^2||Standard Deviation|Mean
763913|NCT00660309|Secondary|Change From Baseline to Steady State Peak in Glomerular Filtration Rate (GFR) After Aliskiren or Irbesartan|"Glomerular filtration rate (GFR) was measured by the clearance of inulin by autoanalyzer methods.
This maximum multiple dose effect (MDE_Max) was calculated as Day 15 peak - Day 2 baseline GFR. Baseline GFR was determined as the median of the -10 minute, -5 minute predose and predose (0 hour) values. Peak GFR was obtained using a moving average concept."|Day 2: Baseline (10 minutes and 5 minutes pre-treatment and 0 hours) and Day 15: 1, 2, 3, 4 and 5 hours post-dose.|Pharmacodynamics (PD) analysis set consisted of all patients with available PD data and no major protocol deviations with impact on PD data. Analysis includes patients for whom data were available.||mL/min/1.73m^2||Standard Deviation|Mean
763914|NCT00660309|Secondary|Change From Baseline to Steady State Trough in Glomerular Filtration Rate (GFR) After Aliskiren or Irbesartan|"Glomerular filtration rate (GFR) was measured by the clearance of inulin by autoanalyzer methods.
This multiple dose effect at steady state (MDE_SS) was calculated as Day 15 baseline - Day 2 baseline GFR. Baseline GFR was determined as the median of the -10 minute, -5 minute predose and predose (0 hour) values."|Day 2 and Day 15 at Baseline (10 minutes and 5 minutes pre-treatment and 0 hours) .|Pharmacodynamics (PD) analysis set consisted of all patients with available PD data and no major protocol deviations with impact on PD data. Analysis includes patients for whom data were available.||mL/min/1.73m^2||Standard Deviation|Mean
763915|NCT00660309|Secondary|Change From Baseline in Glomerular Filtration Rate (GFR) After a Single Dose of Aliskiren or Irbesartan|"Glomerular filtration rate (GFR) was measured by the clearance of inulin by autoanalyzer methods.
The measure of the single dose effect (SDE) for aliskiren and irbesartan was calculated as Day 2 peak - Day 2 baseline GFR. Baseline GFR was determined as the median of the -10 minute, -5 minute predose and predose (0 hour) values. Peak GFR was obtained using a moving average concept."|Day 2: Baseline (10 minutes and 5 minutes pre-treatment and 0 hours) and 1, 2, 3, 4 and 5 hours post-dose.|Pharmacodynamics (PD) analysis set consisted of all patients with available PD data and no major protocol deviations with impact on PD data. Analysis includes patients for whom data were available.||mL/min/1.73m^2||Standard Deviation|Mean
763916|NCT00660309|Primary|Change From Single Dose Peak to Steady State Peak in Renal Plasma Flow (RPF) After Aliskiren or Irbesartan|"Renal plasma flow (RPF) was measured by the clearance of para-aminohippurate (PAH) by autoanalyzer methods.
Accumulation of peak effect from single dose to multiple dose (MDE_Acc) was calculated as Day 15 peak – Day 2 peak. Peak RPF was obtained using a moving average concept."|Day 2 and Day 15: 1, 2, 3, 4 and 5 hours post-dose.|Pharmacodynamics (PD) analysis set consisted of all patients with available PD data and no major protocol deviations with impact on PD data. Analysis includes patients for whom data were available.||mL/min/1.73m^2||Standard Deviation|Mean
763917|NCT00660309|Primary|Change From Baseline to Steady State Peak in Renal Plasma Flow (RPF) After Aliskiren or Irbesartan|"Renal plasma flow (RPF) was measured by the clearance of para-aminohippurate (PAH) by autoanalyzer methods.
This maximum multiple dose effect (MDE_Max) was calculated as Day 15 peak – Day 2 baseline. Baseline RPF was determined as the median of the -10 minute, -5 minute predose and predose (0 hour) values. Peak RPF was obtained using a moving average concept."|Day 2: Baseline (10 minutes and 5 minutes pre-treatment and 0 hours) and Day 15: 1, 2, 3, 4 and 5 hours post-dose.|Pharmacodynamics (PD) analysis set consisted of all patients with available PD data and no major protocol deviations with impact on PD data. Analysis includes patients for whom data were available.||mL/min/1.73m^2||Standard Deviation|Mean
763918|NCT00660309|Primary|Change From Baseline to Steady State Trough in Renal Plasma Flow (RPF) After Aliskiren or Irbesartan|"Renal plasma flow (RPF) was measured by the clearance of para-aminohippurate (PAH) by autoanalyzer methods.
This multiple dose effect at steady state (MDE_SS) was calculated as Day 15 baseline – Day 2 baseline. Baseline RPF was determined as the median of the -10 minute, -5 minute predose and predose (0 hour) values."|Day 2 and Day 15 at Baseline (10 minutes and 5 minutes pre-treatment and 0 hours) .|Pharmacodynamics (PD) analysis set consisted of all patients with available PD data and no major protocol deviations with impact on PD data. Analysis includes patients for whom data were available.||mL/min/1.73m^2||Standard Deviation|Mean
764619|NCT00665925|Secondary|Aspartate Aminotransferase (AST) >2-3x Upper Limit of Normal (ULN)|The number of participants with AST (a test of liver function) values greater than 2 to 3 times the ULN|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.||Participants|||Number
763920|NCT00660309|Secondary|Change From Baseline in Glomerular Filtration Rate (GFR) After a Single Dose of Captopril|"Glomerular filtration rate (GFR) was measured by the clearance of inulin by autoanalyzer methods.
The measure of the single dose effect (SDE) for captopril was calculated as Day 1 peak - Day 1 baseline GFR. Baseline GFR was determined as the median of the -10 minute, -5 minute predose and predose (0 hour) values. Peak GFR was obtained using a moving average concept."|Day 1: Baseline (10 minutes and 5 minutes pre-treatment and 0 hours) and 1, 2, 3, 4 and 5 hours post-dose.|Pharmacodynamics (PD) analysis set consisted of all patients with available PD data and no major protocol deviations with impact on PD data. Analysis includes patients for whom data were available.||mL/min/1.73m^2||Standard Deviation|Mean
763921|NCT00660309|Secondary|Change From Baseline in Renal Plasma Flow (RPF) After a Single Dose of Captopril|"Renal plasma flow (RPF) was measured by the clearance of para-aminohippurate (PAH) by autoanalyzer methods.
The measure of the single dose effect (SDE) for captopril was calculated as Day 1 peak – Day 1 baseline RPF. Baseline RPF was determined as the median of the -10 minute, -5 minute predose and predose (0 hour) values. Peak RPF was obtained using a moving average concept."|Day 1: Baseline (10 minutes and 5 minutes pre-treatment and 0 hours) and 1, 2, 3, 4 and 5 hours post-dose.|Pharmacodynamics (PD) analysis set consisted of all patients with available PD data and no major protocol deviations with impact on PD data.||mL/min/1.73m^2||Standard Deviation|Mean
763922|NCT00660348|Primary|Number of Subjects Per Arm With Decrease in Pain Scores|The primary objective of this study is to compare the effectiveness of pain control between intrathecal opioid delivery and standard analgesia delivery method in patients with locally advanced unresectable or metastatic pancreatic cancer. The primary end point is the number of subjects on each arm showing a decrease in the change in VAS self-assessment pain intensity rating (VAS pain rating) at one month from initial treatment with respect to the baseline pain score. The change is defined as (the Pain Score at one month of the treatment - the Pain Score at baseline). Serial pain scores will be collected at all assessment time points. Min: zero cm. Max 10cm. A higher value means worse pain. Subjects on each arm will report pain on a 10 cm Visual Analogue Scale (VAS) pain rating scale, by making a mark on the 10cm horizontal line with a pen and study team will measure distance from the mark to the start of the scale, which will indicate pain score (eg 1 cm, 3 cm 6 cm, etc.).|1 month|One subject was enrolled, and baseline pain score was obtained on questionnaire, but the subject came off-study before follow-up pain score could be collected. Study terminated shortly thereafter. No outcome data were collected.|||||
763923|NCT00660387|Secondary|Employment Impairment (EMP) II Status at Week 12|The EMP instruments are designed to collect information regarding employment and ability to run a household. EMP I questions include: Are you currently in paid employment? (If yes, at which percentage have you been working during the last 4 weeks?); Have you got someone to run your household for you? (If yes, how much time per week does he/she spend in your household?); Are you retired? (If yes, for which reason?) The retirement question (from EMP I) is excluded from the EMP II instrument.|Week 12 (or early termination)|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment. Missing data was not imputed.||participants|||Number
763924|NCT00660387|Secondary|Employment Impairment (EMP) I Status at Baseline|The EMP instruments are designed to collect information regarding employment and ability to run a household. EMP I questions include: Are you currently in paid employment? (If yes, at which percentage have you been working during the last 4 weeks?); Have you got someone to run your household for you? (If yes, how much time per week does he/she spend in your household?); Are you retired? (If yes, for which reason?).|Baseline|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment. Missing data was not imputed.||participants|||Number
763925|NCT00660387|Secondary|Change From Baseline in EuroQol Quality of Life Scale (EQ-5D) Visual Analogue Scale (VAS) at Week 12|The EQ VAS records the participant's self-rated health on a scale from 0-100 where 100 is the 'best imaginable health state' and 0 is the 'worst imaginable health state.'|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
763926|NCT00660387|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Week 12|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The total score is the sum of the responses to the 31 questions (44 answers) that comprise Parts I-III of the scale. The total score will range from 0-176, with 176 representing the worst (total) disability, and 0 no disability.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
763927|NCT00660387|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Questions 32, 33, and 34 at Week 12|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. Questions 32, 33, and 34 on UPDRS Part IV was totaled to evaluate dyskinesias. Each of these questions is measured on a 5-point scale (0-4). The Part IV dyskinesia score will range from 0-12 and higher scores are associated with more disability.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment. No missing data was imputed.||units on a scale||Standard Error|Least Squares Mean
763928|NCT00660387|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score at Week 12|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part IV Score is the sum of the answers to the 11 questions that comprise Part IV, each of which are measured on a 5-point scale (0-4) or a 2-point scale (0 or 1). The Part IV score ranges from 0-23 and higher scores are associated with more disability.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
763929|NCT00660387|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score at Week 12|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part I Score is the sum of the answers to the 4 questions that comprise Part I, each of which are measured on a 5-point scale (0-4). The Part I score ranges from 0-16 and higher scores are associated with more disability.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment. No missing data was imputed.||units on a scale||Standard Error|Least Squares Mean
763930|NCT00660387|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Bodily Discomfort Domain Score at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Bodily Discomfort includes 3 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
763931|NCT00660387|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Communication Domain Score at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Communication includes 3 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
763932|NCT00660387|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Cognition Domain Score at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Cognition includes 4 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
763933|NCT00660387|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Social Support Domain Score at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Social Support includes 3 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
763934|NCT00660387|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Stigma Domain Score at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Stigma (e.g., social embarrassment) consists of 4 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
763935|NCT00660387|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Emotional Well-Being Domain Score at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Emotional Well-being (e.g., feelings of isolation) includes 6 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
763936|NCT00660387|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Activities of Daily Living Domain Score at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Activities of Daily Living (e.g., difficulty cutting food) includes 6 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
763962|NCT00660595|Secondary|Change From Baseline in Clinical Global Impression, Severity Scale (CGI-S) and in Absolute Clinical Global Impression, Improvement Scale (CGI-I) (Performed 4 Times/ 3 Weeks)|The CGI change was to be measured by calculating the difference between baseline score and 3 week's score. CGI-S Score of 1 = no illness to score of 7 = extremely ill. CGI-I Score of 1 =very much improved since the initiation of treatment to 7=very much worse since the initiation of treatment|baseline and 3 weeks|||units on a scale|||Number
763937|NCT00660387|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Mobility Domain Score at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Mobility (e.g., fear of falling when walking) includes 10 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
763938|NCT00660387|Secondary|"Change From Baseline in Average Daily Normalized On Time With Troublesome Dyskinesia at Week 12"|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis."|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
763939|NCT00660387|Secondary|Change From Baseline in Zarit Burden Interview (ZBI) Total Score at Week 12|The ZBI is a 22-item questionnaire regarding the caregiver/subject relationship and evaluates the caregiver's health condition, psychological well-being, finances and social life. Each question is answered on a 5-point scale (0=Never, 1=Rarely, 2=Sometimes, 3=Quite frequently, and 4= Nearly always). The caregiver burden is evaluated by the total score (Range 0 to 88) obtained from the sum of the answers to the 22 questions. Higher scores are associated with a higher level of burden for the caregiver.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
763940|NCT00660387|Secondary|Change From Baseline in EuroQual Quality of Life - 5 Dimensions (EQ-5D) Summary Index at Week 12|The EQ-5D is a participant answered questionnaire scoring 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that essentially attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 to 1.00 with positive change indicating improvement.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
763941|NCT00660387|Secondary|Change From Baseline in UPDRS Part III Score at Week 12|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part III score is the sum of the 27 answers provided to the 14 Part III questions, each of which are measured on a 5-point scale (0-4). The Part III score ranges from 0-108 and higher scores are associated with more disability.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
763942|NCT00660387|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at Week 12|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part II score is the sum of the answers to the 13 questions that comprise Part II, each of which are measured on a 5-point scale (0-4). The Part II score ranges from 0-52 and higher scores are associated with more disability.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
763943|NCT00660387|Secondary|Clinical Global Impression - Status (CGI-S) Score at Baseline and Clinical Global Impression - Improvement (CGI-I) Score at Week 12|The CGI-S is a global assessment by the Investigator of current symptomatology and impact of illness on functioning. The ratings of the CGI-S are as follows: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, and 7 = among the most extremely ill. The CGI-I is a global assessment by the Investigator of the change in clinical status since the start of treatment. The CGI-I ratings are as follows: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Deviation|Mean
763944|NCT00660387|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The PDQ-39 Summary Index is the sum of all answers divided by the highest score possible (i.e. number of answers multiplied by 4) which is multiplied by 100 to put the score on a 0-100 scale. Higher scores are associated with more severe symptoms.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
763945|NCT00660387|Secondary|"Change From Baseline in Average Daily Normalized On Time Without Troublesome Dyskinesia at Week 12"|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. On time without troublesome dyskinesia (involuntary muscle movement) is defined as On time without dyskinesia and On time with non-troublesome dyskinesia. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Positive change from Baseline for on time without troublesome dyskinesia indicates improvement."|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||hours||Standard Error|Least Squares Mean
763946|NCT00660387|Primary|"Change From Baseline to Week 12 in Average Daily Normalized Off Time"|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Negative change from baseline for off time indicates improvement."|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||hours||Standard Error|Least Squares Mean
763947|NCT00660400|Secondary|Percentage of Participants With Overall Survival (OS)|Overall survival for all participants at one year after first dose of 5-azacitidine (Vidaza). Overall survival was calculated by the method of Kaplan-Meier with standard errors computed using Greenwood's formula.|One year|Participants who proceeded to allogeneic HCT||percentage of participants||95% Confidence Interval|Number
763948|NCT00660400|Secondary|Percentage of Participants Who Proceed to Hematopoietic Cell Transplantation (HCT)|Proportion of patients enrolled who subsequently proceeded to allogeneic HCT.|Up to 3 years|All participants||percentage of participants|||Number
763949|NCT00660400|Secondary|Overall Response Rate (ORR)|Pre-allogeneic HCT responses to 5-azacitidine (Vidaza), based on the International Working Group criteria: Complete Remission (CR); Partial Response (PR); Stable Disease (SD). Point estimates and 95% confidence intervals were calculated for the response rate to 5-azacitidine, evaluated at marrow evaluation after 4 cycles of 5-azacitidine or prior to HCT whichever came first. CR: Bone marrow with 5% myeloblasts and normal maturation of all cell lines. PR: All CR criteria if abnormal before treatment except bone marrow blasts decreased by 50% over pretreatment but still > 5%. SD: Failure to attain CR, PR, relapsed (or progressive) disease.|At the end of up to six (28 day) cycles of 5-azacitidine|Participants who proceeded to allogeneic HCT||percentage of participants|||Number
763950|NCT00660400|Primary|Percentage of Participants With Relapse-free Survival (RFS)|Relapse-free survival one year after allogeneic HCT in MDS patients receiving at least one complete cycle of 5-azacitidine (Vidaza) in the pre-transplantation setting. Relapsed disease: if with complete remission (CR) - greater than 5% blasts in bone marrow; if with partial response (PR) - greater than 30% increase in blasts in the marrow; if with stable disease (SD) - return to pretreatment peripheral blood levels and transfusion requirements due to disease.|One year post allogeneic HCT|Participants who proceeded to allogeneic HCT||percentage of participants||95% Confidence Interval|Number
763951|NCT00660504|Secondary|Objective Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|participants were followed for the duration of the study, an average of 12 weeks|||percentage of participants|||Number
763952|NCT00660504|Secondary|Progression-Free Survival||1.5 years after last subject enrolled|||month||95% Confidence Interval|Median
763953|NCT00660504|Other Pre-specified|Overall Survival at 6 and 12 Months||6 and 12 months.|||percentage of patients||95% Confidence Interval|Number
763954|NCT00660504|Primary|Overall Survival||1.5 years after last subject enrolled|||month||95% Confidence Interval|Median
763955|NCT00660517|Secondary|Change From Baseline in Adult ( Greater Than 18 Years of Age) Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)at the End of 14 Days|Change from Baseline in adult ( greater than 18 years of age) Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)at the end of 14 days The measurement scale is 0 to 24. A reduction in symptom severity score is indicated by a negative value.|day 1 to day 14|Intent to Treat(ITT) population (18 years of age or older) who have had at least one post baseline efficacy evaluation||units on a scale||Standard Deviation|Least Squares Mean
763956|NCT00660517|Secondary|Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (iTNSS)|"change from baseline in the 12 hour instantaneous total nasal symptoms score(iTNSS) consisting of nasal congestion,runny nose,itchy nose and sneezing scored twice daily( AM and PM) in diary cards for the entire 14 day study period.
The measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value."|day 1 to day 14|Intent to Treat (ITT) population includes all subjects who were randomized and had at least one post baseline efficacy evaluation||units on a scale||Standard Deviation|Least Squares Mean
763957|NCT00660517|Primary|Change From Baseline in 12 Hour Reflective Total Nasal Symptom Score (rTNSS)|change from baseline in the 12 hour reflective total nasal symptoms score(rTNSS) consisting of nasal congestion,runny nose,itchy nose and sneezing scored twice daily( AM and PM) in diary cards for the entire 14 day study period The measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value.|day 1 to day14|Intent to Treat (ITT) population includes all subjects who were randomized and had at least one post baseline efficacy observation||units on a scale||Standard Deviation|Least Squares Mean
763958|NCT00660543|Primary|Tumor Progression on Conventional MR|Tumor progression was assessed by RANO criteria (Wen, 2010).|Anytime between baseline and 12 weeks post treatment initiation: average 6 weeks post treatment initiation.|||participants|||Number
763959|NCT00660543|Primary|Mean Cerebral Blood Volume (CBV)|Radiographical progression is determined based on RANO criteria.|At radiographical progression (between 6 and 12 weeks post first dose of chemoradiation)|All patients with treated GMB showed apparent tumor progression on conventional MR images.||mL/g||Standard Deviation|Mean
763960|NCT00660595|Secondary|Change From Baseline in Total Positive and Negative Symptoms Scale (PANSS Score) (Performed 5 Times/ 3 Weeks)|PANSS score change was to be measured by calculating the difference between baseline score and 3 week's score. The PANSS consists of 7 positive and 11 negative items each with associated descriptors. Each descriptor is rated on a 7 point scale from 1=(absence of any symptom) to 7=(extremely severe symptoms).|baseline and 3 weeks|||units on a scale|||Number
763961|NCT00660595|Secondary|Change From Baseline in Overt Aggression Scale (OAS) (Performed 6 Times/ 3 Weeks)|The Overt Agression Scale (OAS) change was to be measured by calculating the difference between baseline score and 3 week's score. Score between 1 and 16 verbal aggression (OAS 1, score 1-4), physical aggression against objects (OAS 2, score 5-8), physical aggression against self (OAS 3, score 9-11) and physical aggression against other people (OAS 4, score 12-16).|baseline and 3 weeks|||units on a scale|||Number
763965|NCT00660660|Secondary|Change From Baseline in Percent Activity Impairment Due to Sleep Disturbances (Average)|To assess the impact of treatment as measured by: Change in global Pittsburgh Sleep Quality Index (PSQI) scores from baseline to week 4. Scale details -'Scoring ranged from 0, “no difficulty” to 3, “severe difficulty.” Items were grouped into 7 component scores. The 7 components were then summed to yield a global PSQI score. Global scores >5 were considered to meet the criteria of sleep disturbance.|Baseline and 4 weeks|||Percentage||Standard Deviation|Mean
763966|NCT00660660|Secondary|Change From Baseline in Percent Overall Work Impairment Due to Sleep Disturbance (Average)|Equivalent number of work hours missed was derived from questions 2, 4 and 5 of the Work Productivity and Activity Impairment Questionnaire: Sleep Disturbance-GERD (Gastroesophageal Reflux Disease) and summed up with the percent work impairment during the remaining hours that were actually worked.|Baseline and 4 weeks|Results based on MITT population with available data for this outcome measure.||Percentage||Standard Deviation|Mean
763967|NCT00660660|Secondary|Change From Baseline in Percent of Work Impairment Because of Sleep Disturbances Due to Gastroesophageal Reflux Disease (GERD) Symptoms (Average)|Degree of sleep disturbance affecting work productivity. 100% is considered to be the worst outcome where there is no ability to work. 0% is considered to be the best outcome, no impairment.|Baseline and 4 weeks|Results based on MITT population with available data for this outcome measure.||Percentage||Standard Deviation|Mean
763968|NCT00660660|Secondary|Equivalent Number of Hours Lost Because of Sleep Disturbances Due to Gastroesophageal Reflux Disease (GERD) Symptoms (Average)||4 weeks|Results based on MITT population with available data for this outcome measure.||Work hours||Standard Deviation|Mean
763969|NCT00660660|Secondary|Percentage of Patients With 24-hour Heartburn Symptom Improvement From Baseline During the Last 7 Days in the Study.|Number of patients with 24-hour heartburn symptom improvement based on weekly symptom scores at Baseline compared to the last week of study drug treatment. Symptom improvement was defined as any decrease in weekly symptom score from Baseline until the last 7 days in the study.|Days 21- 28 (for early dropouts the last 7 days staying in the study)|Results based on MITT population with available data for this outcome measure.||Percentage of participants|||Number
763970|NCT00660660|Secondary|Percentage of Participants With Daytime Heartburn Symptom Improvement From Baseline During the Last 7 Days in the Study|Number of patients with daytime heartburn symptom improvement based on weekly symptom scores at Baseline compared to the last week of study drug treatment. Symptom improvement was defined as any decrease in weekly symptom score from Baseline until the last 7 days in the study.|Days 21-28 (for early dropouts the last 7 days staying in the study)|Results based on MITT population with available data for this outcome measure.||Percentage of participants|||Number
763971|NCT00660660|Secondary|Percentage of Patients With Nighttime Heartburn Symptom Improvement From Baseline During the Last 7 Days in the Study|Number and percentage of patients with nighttime heartburn symptom improvement based on weekly symptom scores at Baseline compared to the last week of study drug treatment. Symptom improvement was defined as any decrease in weekly symptom score from Baseline until the last 7 days in the study.|Days 21- 28 (for early dropouts the last 7 days staying in the study)|Results based on MITT population with available data for this outcome measure.||Percentage of participants|||Number
763972|NCT00660660|Secondary|Percentage of Patients With Relief of 24-hour Heartburn on the Patient's Last 7 Days in the Study|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of 24-hour heartburn on the patient's last 7 days in the study. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “none” on at least 6 of 7 days, allowing for 1 “mild” response.|Days 21- 28 (for early dropouts the last 7 days staying in the study)|Results based on MITT population with available data for this outcome measure.||Percentage of participants|||Number
763973|NCT00660660|Secondary|Percentage of Patients With Relief of 24-hour Heartburn After 4 Weeks of Treatment|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of 24-hour heartburn after 4 weeks of treatment. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “none” on at least 6 of 7 days, allowing for 1 “mild” response.|4 weeks|Results based on MITT population with available data for this outcome measure.||Percentage of participants|||Number
763974|NCT00660660|Secondary|Percentage of Patients With Relief of 24-hour Heartburn After 2 Weeks of Treatment|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of 24-hour heartburn after 2 weeks of treatment. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “none” on at least 6 of 7 days, allowing for 1 “mild” response.|2 weeks|Results based on MITT population with available data for this outcome measure.||Percentage of participants|||Number
763975|NCT00660660|Secondary|Percentage of Patients With Relief of 24-hour Heartburn After 1 Week of Treatment|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of 24-hour heartburn after 1 week of treatment. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “none” on at least 6 of 7 days, allowing for 1 “mild” response.|1 week|Results based on MITT population with available data for this outcome measure.||Percentage of participants|||Number
763976|NCT00660660|Secondary|Percentage of Patients With Relief of Nighttime Heartburn on the Patient's Last 7 Days in the Study|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of nighttime heartburn on the patient's last 7 days in the study. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “none” on at least 6 of 7 days, allowing for 1 “mild” response.|Days 21- 28 (for early dropouts the last 7 days staying in the study)|Results based on MITT population with available data for this outcome measure.||Percentage of participants|||Number
763977|NCT00660660|Secondary|Percentage of Patients With Relief of Nighttime Heartburn After 4 Weeks of Treatment|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of nighttime heartburn after 4 weeks of treatment. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “none” on at least 6 of 7 days, allowing for 1 “mild” response.|4 weeks|Results based on MITT population with available data for this outcome measure.||Percentage of participants|||Number
764620|NCT00665925|Secondary|Aspartate Aminotransferase (AST) >1.5-2x Upper Limit of Normal (ULN)|The number of participants with AST (a test of liver function) values greater than 1.5-2 times the ULN|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.||Participants|||Number
763978|NCT00660660|Secondary|Percentage of Patients With Relief of Nighttime Heartburn After 2 Weeks of Treatment|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of nighttime heartburn after 2 weeks of treatment. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “none” on at least 6 of 7 days, allowing for 1 “mild” response.|2 weeks|Results based on MITT population with available data for this outcome measure.||Percentage of participants|||Number
763979|NCT00660660|Secondary|Percentage of Patients With Relief of Nighttime Heartburn After 1 Week of Treatment.|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of nighttime heartburn after 1 week of treatment. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “none” on at least 6 of 7 days, allowing for 1 “mild” response.|1 week|Results based on MITT population with available data for this outcome measure.||Percentage of participants|||Number
763980|NCT00660660|Secondary|Percentage of Patients With Relief of Daytime Heartburn on the Patient's Last 7 Days in the Study|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of daytime heartburn on the patient's last 7 days in the study. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “none” on at least 6 of 7 days, allowing for 1 “mild” response.'|Days 21- 28 (for early dropouts the last 7 days staying in the study)|Results based on MITT population with available data for this outcome measure.||Percentage of participants|||Number
763981|NCT00660660|Secondary|Percentage of Patients With Relief of Daytime Heartburn After 4 Weeks of Treatment|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of daytime heartburn after 4 weeks of treatment. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “none” on at least 6 of 7 days, allowing for 1 “mild” response.'|4 weeks|Results based on MITT population with available data for this outcome measure.||Percentage of participants|||Number
763982|NCT00660660|Secondary|Percentage of Patients With Relief of Daytime Heartburn After 2 Weeks of Treatment|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of daytime heartburn after 2 weeks of treatment. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “none” on at least 6 of 7 days, allowing for 1 “mild” response.'|2 weeks|Results based on MITT population with available data for this outcome measure.||Percentage of participants|||Number
763983|NCT00660660|Secondary|Percentage of Patients With Relief of Daytime Heartburn After 1 Week of Treatment|"To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of daytime heartburn after 2 weeks of treatment. Results based on MITT population with available data for this outcome measure. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of none on at least 6 of 7 days, allowing for 1 mild response.'"|1 week|Results based on MITT population with available data for this outcome measure.||Percentage of participants|||Number
763984|NCT00660660|Secondary|Percentage of Patients With Complete Resolution of 24-hour Heartburn on the Patient's Last 7 Days in the Study|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of 24-hour heartburn on the patient's last 7 days in the study. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “None” on 7 consecutive days.|Days 21- 28 (for early dropouts the last 7 days staying in the study)|Results based on MITT population with available data for this outcome measure.||Percentage of participants|||Number
763985|NCT00660660|Secondary|Percentage of Patients With Complete Resolution of 24-hour Heartburn After 4 Weeks of Treatment|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of 24-hour heartburn after 4 weeks of treatment. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “None” on 7 consecutive days.|4 weeks|Results based on MITT population with available data for this outcome measure.||Percentage of participants|||Number
763986|NCT00660660|Secondary|Percentage of Patients With Complete Resolution of 24-hour Heartburn After 2 Weeks of Treatment|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of 24-hour heartburn after 2 weeks of treatment. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “None” on 7 consecutive days.|2 weeks|Results based on MITT population with available data for this outcome measure.||Percentage of participants|||Number
763987|NCT00660660|Secondary|Percentage of Patients With Complete Resolution of 24-hour Heartburn After 1 Week of Treatment|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of 24-hour heartburn after 1 week of treatment. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “None” on 7 consecutive days.|1 week|Results based on MITT population with available data for this outcome measure.||Percentage of participants|||Number
763988|NCT00660660|Secondary|Percentage of Patients With Complete Resolution of Nighttime Heartburn on the Patient's Last 7 Days in the Study.|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of nighttime heartburn on the patient's last 7 days in the study. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “None” on 7 consecutive days.|Days 21- 28 (for early dropouts the last 7 days staying in the study)|Results based on MITT population with available data for this outcome measure.||Percentage of participants|||Number
763989|NCT00660660|Secondary|Percentage of Patients With Complete Resolution of Nighttime Heartburn After 4 Weeks of Treatment|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of nighttime heartburn after 4 weeks of treatment. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “None” on 7 consecutive days.|4 weeks|Results based on MITT population with available data for this outcome measure.||Percentage of participants|||Number
763990|NCT00660660|Secondary|Percentage of Patients With Complete Resolution of Nighttime Heartburn After 2 Weeks of Treatment|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of nighttime heartburn after 2 weeks of treatment. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “None” on 7 consecutive days.|2 weeks|Results based on MITT population with available data for this outcome measure.||Percentage of participants|||Number
763991|NCT00660660|Secondary|Percentage of Patients With Complete Resolution of Nighttime Heartburn After 1 Week of Treatment.|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of nighttime heartburn after 1 week of treatment. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “None” on 7 consecutive days.|1 week|Results based on MITT population with available data for this outcome measure.||Percentage of participants|||Number
763992|NCT00660660|Secondary|Percentage of Patients With Complete Resolution of Daytime Heartburn on the Patient's Last 7 Days in the Study|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of daytime heartburn on the patient's last 7 days in the study. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “None” on 7 consecutive days.|Days 21- 28 (for early dropouts the last 7 days staying in the study)|Results based on MITT population with available data for this outcome measure.||Percentage of participants|||Number
763993|NCT00660660|Secondary|Percentage of Patients With Complete Resolution of Daytime Heartburn After 4 Weeks of Treatment|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of daytime heartburn after 4 weeks of treatment. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “None” on 7 consecutive days.|4 weeks|Results based on MITT population with available data for this outcome measure.||Percentage of participants|||Number
763994|NCT00660660|Secondary|Percentage of Patients With Complete Resolution of Daytime Heartburn After 2 Weeks of Treatment|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of daytime heartburn after 2 weeks of treatment. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “None” on 7 consecutive days.|2 weeks|Results based on MITT population with available data for this outcome measure.||Percentage of participants|||Number
763995|NCT00660660|Secondary|Percentage of Patients With Complete Resolution of Daytime Heartburn After 1 Week of Treatment|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of daytime heartburn after 1 week of treatment. Results based on MITT population with available data for this outcome measure. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “None” on 7 consecutive days.|1 week|||Percentage of participants|||Number
763996|NCT00660660|Secondary|Number of Days to First Complete Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) During the 4 Week Treatment Period|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on sleep disturbances associated with Gastroesophageal Reflux Disease (GERD), as measured by: Days to complete resolution of sleep disturbance. Days to complete resolution of sleep disturbances associated with GERD was defined as the number of days until the first day of the first 7‑consecutive-day period during which the patient’s daily diary response was “No” (did not have trouble sleeping due to GERD symptoms).'|4 weeks|Results based on MITT population with available data for this outcome measure.||Days||Full Range|Median
763997|NCT00660660|Secondary|Number of Days to Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) During the 4 Week Treatment Period|The assessment was based on patients registrations of the answers “Yes” or “No” to the question: “Did you have trouble sleeping last night due to your heartburn or other symptoms of Gastroesophageal Reflux Disease (GERD)?”. Relief of sleep disturbances associated with GERD was defined as a daily diary response of “Yes” on not more than 2 of 7 consecutive days.|4 weeks|||Days||Full Range|Median
763998|NCT00660660|Secondary|Number of Days to First Relief of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) During the 4 Week Treatment Period|The assessment was based on patients registrations of the answers “Yes” or “No” to the question: “Did you have trouble sleeping last night due to your heartburn or other symptoms of Gastroesophageal Reflux Disease (GERD)?”. Relief of sleep disturbances associated with GERD was defined as a daily diary response of “Yes” on not more than 2 of 7 consecutive days, and ‘days to first relief’ was defined as the first day of the 7 days that reached relief of sleep disturbance.|4 weeks|Results based on MITT population with available data for this outcome measure.||Days||Full Range|Median
763999|NCT00660660|Secondary|Percentage of Days Without Gastroesophageal Reflux Disease (GERD)-Related Sleep Disturbances During the 4 Week Period|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on sleep disturbances associated with Gastroesophageal Reflux Disease (GERD)as measured by: Percent of days without sleep disturbances after 4 weeks of treatment. Each morning of the study, patients registered their answer “Yes” or “No” to the question, “Did you have trouble sleeping last night due to your heartburn or other symptoms of GERD?” in the diary card.'|4 weeks|Results based on MITT population with available data for this outcome measure.||Percentage of days||Standard Deviation|Mean
764000|NCT00660660|Secondary|Percentage of Patients With Relief of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) on the Patient's Last 7 Days in the Study.|The assessment was based on patients registrations of the answers “Yes” or “No” to the question: “Did you have trouble sleeping last night due to your heartburn or other symptoms of Gastroesophageal Reflux Disease (GERD)?”. Relief of sleep disturbances associated with GERD was defined as a daily diary response of “Yes” on not more than 2 of 7 consecutive days.|Days 21- 28 (for early dropouts the last 7 days staying in the study)|Results based on MITT population with available data for this outcome measure.||Percentage of Participants|||Number
764001|NCT00660660|Secondary|Number of Patients With Relief of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 4 Weeks of Treatment|The assessment was based on patients registrations of the answers “Yes” or “No” to the question: “Did you have trouble sleeping last night due to your heartburn or other symptoms of Gastroesophageal Reflux Disease (GERD)?”. Relief of sleep disturbances associated with GERD was defined as a daily diary response of “Yes” on not more than 2 of 7 consecutive days.|4 weeks|Results based on MITT population with available data for this outcome measure.||Participants|||Number
764019|NCT00660699|Secondary|Toxicities Associated With Treatment (Grade 3-4)|Toxicity was graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 2.0. The most common grade 3-4 non-hematologic and hematologic toxicities were collected for this outcome.|30 days after completion of treatment (treatment lasts approximately 19 weeks)|||percentage of participants|||Number
764002|NCT00660660|Secondary|Number of Patients With Relief of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 2 Weeks of Treatment|The assessment was based on patients registrations of the answers “Yes” or “No” to the question: “Did you have trouble sleeping last night due to your heartburn or other symptoms of Gastroesophageal Reflux Disease (GERD)?”. Relief of sleep disturbances associated with GERD was defined as a daily diary response of “Yes” on not more than 2 of 7 consecutive days.|2 weeks|Results based on MITT population with available data for this outcome measure.||Participants|||Number
764003|NCT00660660|Secondary|Number of Patients With Relief of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 1 Week of Treatment|The assessment was based on patients registrations of the answers “Yes” or “No” to the question: “Did you have trouble sleeping last night due to your heartburn or other symptoms of Gastroesophageal Reflux Disease (GERD)?”. Relief of sleep disturbances associated with GERD was defined as a daily diary response of “Yes” on not more than 2 of 7 consecutive days.|1 week|Results based on MITT population with available data for this outcome measure.||Participants|||Number
764004|NCT00660660|Secondary|Number of Patients With Complete Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) on the Patient's Last 7 Days in the Study.|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on sleep disturbances associated with Gastroesophageal Reflux Disease (GERD), as measured by: Complete resolution of sleep disturbances on the patient's last 7 days in the study.|Days 21- 28 (for early dropouts the last 7 days staying in the study)|Results based on MITT population with available data for this outcome measure.||Participants|||Number
764005|NCT00660660|Secondary|Number of Patients With Complete Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 4 Weeks of Treatment.|The assessment was based on patients registrations of the answers “Yes” or “No” to the question: “Did you have trouble sleeping last night due to your heartburn or other symptoms of GERD?”. Complete resolution of Gastroesophageal Reflux Disease (GERD)-related sleep disturbances was defined as a daily diary response of “No” on 7 consecutive days during 4 weeks of treatment.|4 weeks|||Participants|||Number
764006|NCT00660660|Secondary|Number of Patients With Complete Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 2 Weeks of Treatment.|The assessment was based on patients registrations of the answers “Yes” or “No” to the question: “Did you have trouble sleeping last night due to your heartburn or other symptoms of Gastroesophageal Reflux Disease (GERD)?”. Complete resolution of GERD-related sleep disturbances was defined as a daily diary response of “No” on 14 consecutive days.|2 weeks|||Participants|||Number
764007|NCT00660660|Secondary|Number of Patients With Complete Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 1 Week of Treatment.|The assessment was based on patients registrations of the answers “Yes” or “No” to the question: “Did you have trouble sleeping last night due to your heartburn or other symptoms of Gastroesophageal Reflux Disease (GERD)?”. Complete resolution of GERD-related sleep disturbances was defined as a daily diary response of “No” on 7 consecutive days.|1 week|||Participants|||Number
764008|NCT00660660|Secondary|Achievement of Developer-defined Good Sleep|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on sleep disturbances associated with ‎Gastroesophageal reflux disease (GERD), as measured by achievement of (yes/no) developer-defined good sleep (global Pittsburgh Sleep Quality Index - PSQI score ≤5) at Week 4.|4 weeks|Results based on MITT population with available data for this outcome measure.||Participants|||Number
764009|NCT00660660|Secondary|Change in Mean (Average) Pittsburgh Sleep Quality Index (PSQI) Scores From Baseline|To assess the impact of treatment as measured by: Change in global Pittsburgh Sleep Quality Index (PSQI) scores from baseline to week 4. Scale details -'Scoring ranged from 0, “no difficulty” to 3, “severe difficulty.” Items were grouped into 7 component scores. The 7 components were then summed to yield a global PSQI score. Global scores >5 were considered to meet the criteria of sleep disturbance.|Baseline and 4 weeks|Results based on MITT population with available data for this outcome measure.||Scores on a scale||Standard Deviation|Least Squares Mean
764010|NCT00660660|Primary|Percentage of Patients With Relief of Nighttime Heartburn During the Last 7 Days of the Study.|Relief of nighttime heartburn on patient’s last 7 days in the study. Relief was defined as a daily diary card response of “none” or 0, on at least 6 of 7 days, allowing for one “mild” or 1 response. Diary card scale (none, mild, moderate, severe).|Days 21- 28 (for early dropouts the last 7 days staying in the study)|Results based on MITT population with available data for this outcome measure.||Percentage of participants|||Number
764011|NCT00660699|Secondary|Overall Survival (OS)|OS was defined as the time from the initiation of treatment to death from any cause or last follow-up|1 year|30 out of 48 participants completed all components of study treatment.||percentage of participants||95% Confidence Interval|Number
764012|NCT00660699|Secondary|Overall Survival (OS) - Median|OS was defined as the time from the initiation of treatment to death from any cause or last follow-up.|Median follow-up was 24 months (range 3.2-97 months)|30 out of 48 participants completed all components of study treatment.||months||95% Confidence Interval|Median
764013|NCT00660699|Secondary|Overall Survival (OS)|OS was defined as the time from the initiation of treatment to death from any cause or last follow-up|2 years|||percentage of participants||95% Confidence Interval|Number
764014|NCT00660699|Post-Hoc|Incidence of Disease Recurrence||Median follow-up was 24 months (range 3.2-97 months)|||percentage of participants|||Number
764015|NCT00660699|Secondary|Overall Survival (OS)|OS was defined as the time from the initiation of treatment to death from any cause or last follow-up|1 year|||percentage of participants||95% Confidence Interval|Number
764016|NCT00660699|Secondary|Overall Survival (OS) - Median|OS was defined as the time from the initiation of treatment to death from any cause or last follow-up.|Median follow-up was 24 months (range 3.2-97 months)|||months||95% Confidence Interval|Median
764017|NCT00660699|Secondary|Disease Free Survival (DFS) - Median|DFS was defined as the time from the initiation of treatment to relapse or death, whichever occurred first.|Median follow-up was 24 months (range 3.2-97 months)|30 out of 48 participants completed all components of the study therapy.||months||95% Confidence Interval|Median
764018|NCT00660699|Secondary|Disease Free Survival (DFS) - Median|DFS was defined as the time from the initiation of treatment to relapse or death, whichever occurred first.|Median follow-up was 24 months (range 3.2-97 months)|||months||95% Confidence Interval|Median
764020|NCT00660699|Secondary|Toxicities Associated With Treatment (Grade 1-2)|Toxicity was graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 2.0. The most common grade 1-2 non-hematologic and hematologic toxicities were collected for this outcome.|30 days after completion of treatment (treatment lasts approximately 19 weeks)|||percentage of participants|||Number
764021|NCT00660699|Primary|Incidence of Severe Toxicities|Toxicity was graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 2.0|1 month after completion of treatment (treatment lasts approximately 19 weeks)|||percentage of participants|||Number
764022|NCT00661193|Secondary|Response Rate (Confirmed and Unconfirmed, Complete and Partial Response) in a Subset of Patients With Measurable Disease|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI:
Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|From date of registration to 3 years or death, whichever comes first|Although 33 patients were eligible for Erlotinib Hydrochloride, only 32 were evaluable for response due to one patient not having measurable disease at baseline.||participants|||Number
764023|NCT00661193|Primary|Selection of One of Two Treatment Regimens (Erlotinib Hydrochloride With or Without Carboplatin and Paclitaxel) for Further Study in a Phase III Trial, Based on Median Progression-free Survival for ≥ 3 Months||From date of registration to 3 years or death, whichever comes first|||months||95% Confidence Interval|Median
764024|NCT00661258|Primary|Mean Adherence, as Measured by Electronic Drug Monitors (EDM)|We used the electronic drug monitors (EDM) adherence metric that was found to be most strongly associated with viral suppression (HIV RNA <400 copies/ml) in analysis of the pre-intervention data, EDM ‘proportion taken within dose time’ (see Gill et al, 2009). This measure estimated monthly adherence as the proportion of prescribed doses taken on time, e.g., within 1 hour of scheduled dose time ([number of doses taken ±1 hour of dose time] / [total number of prescribed doses]).|Month 12 (last month of 6-month intervention period) and 6-month post-intervention period|Of 68 subjects randomized at 6 months, 64 completed the full 12 months of data collection, 31 in Intervention Arm and 33 in Comparison Arm.||percentage of doses taken on time||Standard Deviation|Mean
764025|NCT00661258|Secondary|Change in CD4 Count|Mean change in CD4 count (cells/µL) between Month 6 and Month 12 (pre-intervention vs. last month of intervention)|Month 6, Month 12|||cells/µL||Standard Deviation|Mean
764026|NCT00661362|Secondary|Proportion of Patients Achieving a Therapeutic Glycemic Response|Proportion of participants achieving a therapeutic glycemic response, defined as having HbA1c < 7.0% for saxagliptin + metformin versus placebo + metformin at week 24|Baseline , Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Wk 24(LOCF) for efficacy, subjects must have had a baseline and at least 1 post baseline efficacy measurement.||Percentage of participants|||Number
764027|NCT00661362|Secondary|Change From Baseline in the Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During a Mixed Meal Tolerance Test (MMTT) in a Subgroup|Adjusted* mean change from baseline in PPG AUC achieved with saxagliptin 5 mg + metformin versus placebo+metformin at week 24 (LOCF, Full Analysis set). Trapezoidal method was used to compute AUC under the 3 hour PPG curve. The change from baseline for each subject is calculated as the week 24 value minus the baseline value. *Adjusted for baseline PPG AUC.|Baseline , Week 24|MMTT was measured on a subset of patients in China cohort only at baseline and Wk 24. Randomized participants who took at least 1 dose of double-blind treatment to be included in analysis: change from baseline to Wk 24 (LOCF), must have had a baseline and a post baseline data.||mg*min/dL||Standard Error|Mean
764028|NCT00661362|Secondary|Change From Baseline in the Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During a Mixed Meal Tolerance Test (MMTT) in a Subgroup|Adjusted* mean change from baseline in PPG AUC achieved with saxagliptin 5 mg + metformin versus placebo + metformin at week 24 (LOCF, Full Analysis set). Trapezoidal method was used to compute AUC under the 3 hour PPG curve. The change from baseline for each subject is calculated as the week 24 value minus the baseline value. *Adjusted for baseline PPG AUC.|Baseline , Week 24|MMTT was measured on a subset of patients in China cohort only at baseline and Wk 24. Randomized participants who took at least 1 dose of double-blind treatment to be included in analysis: change from baseline to Wk 24 (LOCF), must have had a baseline and a post baseline data.||mmol*min/L||Standard Error|Mean
764029|NCT00661362|Secondary|Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) mg/dL|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg + metformin versus placebo + metformin at week 24 (LOCF, Full Analysis set). FPG is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. *Adjusted for baseline FPG.|Baseline , Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Wk 24 LOCF for efficacy, subjects must have had a baseline and at least 1 post baseline efficacy measurement||mg/dL||Standard Error|Mean
764030|NCT00661362|Secondary|Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) mmol/L|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg + metformin versus placebo + metformin at week 24 (Last Observation Carried Out (LOCF), Full Analysis set). FPG is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. *Adjusted for baseline FPG.|Baseline , Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Wk 24 LOCF for efficacy, subjects must have had a baseline and at least 1 post baseline efficacy measurement||mmol/L||Standard Error|Mean
764031|NCT00661362|Primary|Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c)|Adjusted* mean change from baseline in HbA1c achieved with saxagliptin 5 mg + metformin versus placebo + metformin at week 24 (LOCF, Full Analysis set). HbA1c is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. *Adjusted for baseline HbA1c.|Baseline , Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Wk 24 LOCF for efficacy, subjects must have had a baseline and at least 1 post baseline efficacy measurement.||percent||Standard Error|Mean
764621|NCT00665925|Secondary|Aspartate Aminotransferase (AST) >1.5x Upper Limit of Normal (ULN)|The number of participants with AST (a test of liver function) values greater than 1.5 times the ULN|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.||Participants|||Number
764032|NCT00661388|Secondary|Mean Change From Baseline in Transferrin Saturation Over Time|Mean change from Baseline in transferrin saturation (TSAT) was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.|Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants analyzed at a particular visit is determined by 'n'.||Percentage of Transferrin Saturation||Standard Deviation|Mean
764033|NCT00661388|Secondary|Mean Change From Baseline in Ferritin Concentration Over Time|Mean change from Baseline in ferritin concentration was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.|Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants analyzed at a particular visit is determined by 'n'.||mcg/L||Standard Deviation|Mean
764034|NCT00661388|Secondary|Mean Change From Baseline in Creatinine Concentration Over Time|Mean change from Baseline in creatinine concentration was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.|Baseline (Week 0), Weeks 8, 16, 32, 40|Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants analyzed at a particular visit is determined by 'n'.||Micromole/L||Full Range|Median
764035|NCT00661388|Secondary|Mean Change From Baseline in Total Iron Binding Capacity and Iron Concentrations Over Time|Mean change from Baseline in total iron binding capacity (TIBC) and iron concentrations was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.|Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants analyzed at a particular visit is determined by 'n'.||Micromole /L||Standard Deviation|Mean
764036|NCT00661388|Secondary|Mean Change From Baseline in Phosphate and Potassium Concentrations Over Time|Mean change from Baseline in phosphate and potassium concentrations was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.|Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants analyzed at a particular visit is determined by 'n'.||Millimoles /L||Standard Deviation|Mean
764037|NCT00661388|Secondary|Mean Change From Baseline in C-Reactive Protein Concentration Over Time|Mean change from Baseline in C-Reactive Protein concentration was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.|Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants analyzed at a particular visit is determined by 'n'.||Milligrams /L||Standard Deviation|Mean
764038|NCT00661388|Secondary|Mean Change From Baseline in Albumin Concentration Over Time|Mean change from Baseline in albumin concentration was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.|Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants analyzed at a particular visit is determined by 'n'.||g/L||Standard Deviation|Mean
764039|NCT00661388|Secondary|Mean Change From Baseline in White Blood Cells and Platelets Concentrations Over Time|Mean change from Baseline in white blood cells (WBCs) and platelets concentrations was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.|Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants analyzed at a particular visit is determined by 'n'.||10^9 cells/Liter (L)||Standard Deviation|Mean
764040|NCT00661388|Secondary|Mean Change From Baseline in Erythrocyte Mean Corpuscular Volume Over Time|Mean change from Baseline in erythrocyte mean corpuscular volume was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.|Baseline (Week 0), Weeks 8, 16, 24, 32, and 48|Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants analyzed at a particular visit is determined by 'n'.||Femtoliters||Standard Deviation|Mean
764041|NCT00661388|Secondary|Mean Change From Baseline in Hematocrit Level Over Time|Mean change from Baseline in hematocrit level was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.|Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants analyzed at a particular visit is determined by 'n'.||Fraction||Standard Deviation|Mean
764042|NCT00661388|Secondary|Mean Change From Baseline in Hb Concentration Over Time|Mean change from Baseline in Hb concentration was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.|Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants analyzed at a particular visit is determined by 'n'.||g/dL||Standard Deviation|Mean
764043|NCT00661388|Secondary|Number of Participants Who Experienced Any Adverse Events or Serious Adverse Events|An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.|Up to Week 52|Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not.||Participants|||Number
764044|NCT00661388|Secondary|Number of Participants Who Received Red Blood Cell Transfusions During the Study Period|Red blood cell transfusions were given during the treatment period in case of medical need. Blood transfusions occurred during the DTP (Week 0 to Week 28), EEP (Week 29 to Week 36), and during the long term safety period (LSTP [Week 37 to Week 52]) are presented.|Up to Week 52|Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants who entered a particular phase is determined by ‘n’.||Number of participants|||Number
764045|NCT00661388|Secondary|Percentage of Participants Requiring Dose Adjustments During Dose Titration Period and EEP|Percentage of participants requiring dose adjustments during dose titration period (DTP [Week 0 to Week 28]) and EEP (Week 29 to Week 36) is presented. The dose adjustments (increase or decrease) were required: if a single Hb concentration was either ≥ 13 g/dL or < 9 g/dL; if the difference of 2 consecutive Hb concentrations was ≥2 g/dL; if the values of scheduled Hb assessments on the day of administration of C.E.R.A. and on the previous study visit were both out of range of 10 to 12 g/dL; if the values of the scheduled Hb assessments on the day of administration of C.E.R.A. and on the previous study visit were both out of the range 10.5 to 11.5 g/dL. Dose adjustment could be made at any time at the discretion of the clinician if clinically warranted.|Weeks 0 to Week 36|PP population included all participants who received at least one dose of C.E.R.A. and had at least one follow-up. Participants with less than three recorded Hb values during EEP; missing administration of C.E.R.A. during weeks 28-36; having inadequate iron status, were excluded.||Percentage of participants|||Number
764046|NCT00661388|Secondary|Mean Time Spent by Participants in the Target Range of 10.0- 12.0 g/dL During the EEP|Mean time spent by participants in the target range of 10.0- 12.0 g/dL during the EEP (Week 29 to Week 36) is presented.|From Week 29 to Week 36|PP population included all participants who received at least one dose of C.E.R.A. and had at least one follow-up. Participants with less than three recorded Hb values during EEP; missing administration of C.E.R.A. during weeks 28-36; having inadequate iron status, were excluded.||Days||Standard Deviation|Mean
764047|NCT00661388|Secondary|The Percentage of Participants Whose Hb Concentrations Remained Within the Target Range of 10.0- 12.0 g/dLThroughout the EEP|The percentage of participants whose Hb Concentrations remained within the target range of 10.0- 12.0 g/dL throughout the EEP (Week 29 to Week 36) is presented.|From Week 29 to Week 36|PP population included all participants who received at least one dose of C.E.R.A. and had at least one follow-up variable were included. Participants with less than three recorded Hb values during EEP; participants missing administration of C.E.R.A. during weeks 28-36; participants with inadequate iron status, were excluded.||Percentage of participants||95% Confidence Interval|Number
764048|NCT00661388|Secondary|Mean Time to Achievement of Response During the EEP|Participants with Hb concentrations within target range of 10-12 g/dl were considered to be responders. Mean time to achievement of response during the EEP (Week 29 to Week 36) is presented.|From Week 29 to Week 36|PP population included all participants who received at least one dose of C.E.R.A. and had at least one follow-up. Participants with less than three recorded Hb values during EEP; missing administration of C.E.R.A. during weeks 28-36; having inadequate iron status, were excluded.||Days||Standard Deviation|Mean
764049|NCT00661388|Primary|Mean Change in Hb Concentration Between Baseline and the Efficacy Evaluation Period|Mean change in Hb concentration was calculated as the difference between the time adjusted average of Hb during the efficacy evaluation period (EEP [Week 29 to Week 36]), and the Hb at Baseline (Week 0). A positive change from baseline indicates improvement.|From Baseline (Week 0) to EEP (Week 29 to Week 36)|Per protocol (PP) population included all participants who received at least one dose of C.E.R.A. and had at least one follow-up. Participants with less than three recorded Hb values during EEP; missing administration of C.E.R.A. during weeks 28-36; having inadequate iron status, were excluded.||g/dL||Standard Deviation|Mean
764052|NCT00661453|Secondary|Whole Body DEXA Scanning for Lean Body Mass and Total Bone Mineral Density/ Content||-2 weeks or time 0, 3 months, 6 months||||||
764053|NCT00661453|Secondary|Maximum Ulnar CMAP Amplitude/Area and MUNE||-2 weeks, time 0, 3 months, 6 months||||||
764054|NCT00661453|Secondary|Quantitative SMN mRNA and Protein Measures||-2 weeks, time 0 , 3 months, or 6 months||||||
764055|NCT00661453|Secondary|Functional Motor Assessments: TIMPSI Scores||-2 weeks, time 0, 3 months, 6 months||||||
764056|NCT00661453|Secondary|Primary Caregiver Functional Rating Scale for SMA Type I Subjects (PCFRS)||time 0, and monthly for 12 months||||||
764057|NCT00661453|Secondary|Time to Death or Ventilator Dependence (Defined as >16 Hours/Day)||monthly||||||
764058|NCT00661453|Primary|Anthropometric Measures of Nutritional Status (Body Mass Index [BMI] Z-scores, Weight for Length Ratios, Lean/Fat Mass Via DEXA, Growth Parameters, and Triceps Skinfold Measures)||-2 weeks, time 0, 3 months, 6 months|20 participants have baseline values, only 12 have 3 and 6 month values||g||Standard Deviation|Mean
764059|NCT00661453|Primary|Laboratory Safety Data||-2 weeks, + 2 weeks, 3 months, 6 months||||||
767373|NCT00694122|Secondary|Insulin Dose|NPH or glargine (Lantus) was given at 22:00 to provide blood glucose coverage during the overnight hours.|Overnight|||units||Standard Deviation|Mean
764060|NCT00661479|Secondary|Change From Baseline in Contrast Sensitivity in the Study Eye|Change from baseline in contrast sensitivity in the study eye is measured using a Pelli-Robson contrast sensitivity chart at 1 meter. The contrast sensitivity chart contains letters that are darkest at the top and then get progressively lighter. Scores range from 0 to 48 and are based on the number of letters read correctly. A negative change from baseline indicates a worsening in contrast sensitivity and a positive change from baseline indicates an improvement.|Baseline, Month 6|Safety Population: all patients treated on Day 1||Number of Letters Read Correctly||Standard Deviation|Mean
764061|NCT00661479|Primary|Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening.|Baseline, Month 6|Safety Population: all patients treated on Day 1||Number of Letters Read Correctly||Standard Deviation|Mean
764062|NCT00661492|Secondary|Median Overall Survival (OS)|OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.|30 months|ITT population||months||Full Range|Median
764063|NCT00661492|Secondary|Median Progression-free Survival (PFS)|PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date.|24 months|ITT population||months||Full Range|Median
764064|NCT00661492|Secondary|Prostate-specific Antigen (PSA) Doubling Time|PSA doubling time = [log (2)× t] ÷ [log (final PSA) - log (initial PSA)]|24 months|Evaluable Population with Prostate-specific antigen (PSA) Information||months||Full Range|Median
764065|NCT00661492|Secondary|Prostate-specific Antigen (PSA) Response Rate|Defined as the fraction of patients with a ≥50% reduction in serum PSA confirmed by a second serum PSA at least 3 weeks later|24 months|Evaluable Population with Prostate-specific antigen (PSA) Information||percentage of participants||95% Confidence Interval|Number
764066|NCT00661492|Secondary|Median Time to Prostate-specific Antigen (PSA) Progression|Defined as the time from initiation of therapy until the first 25% increase from baseline in non-responders or 50% increase from nadir in responders as defined above. A minimum increase in the PSA of 5 ng/mL will be required for progression.|24 months|Patients with Prostate-specific antigen (PSA) Information||Months||Full Range|Median
764067|NCT00661492|Secondary|Objective Response Rate (ORR)|ORR = CR + PR Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.|24 months|Patients with solid tumors||percentage of participants||95% Confidence Interval|Number
764068|NCT00661492|Secondary|2-year Radiographically Evident Progression-free Survival (REPFS).|"Radiographic progression:
1) For bone scan, 2 unequivocal new lesions confirmed by a subsequent bone scan with at least 1 more new lesion; 2) Skeletal related event (eg, fracture, need for radiation to bone for pain, spinal cord compression, need for surgery to bone to prevent or treat a pathologic fracture)."|24 months.|Patients who received bone scans or had bone progression only (bone pain/pathologic fracture/palliative radiation).||Probability of REPFS at 2-year||95% Confidence Interval|Number
764069|NCT00661492|Primary|Median Time to Progression (TTP)|TTP will be measured from the start of treatment date to the date the patient is first recorded as having disease progression (even in patients who discontinue study treatment early due to toxicity or death due to disease progression.|24 months|ITT population||Months||Full Range|Median
764070|NCT00661505|Secondary|Number of Participants Who Received Red Blood Cell Transfusions During the Dose Titration Period and Efficacy Evaluation Period|Red blood cell transfusions were permitted during the DTP and EEP (Week 1 to Week 24) in case of medical need. All participants requiring a blood transfusion were withdrawn from the study. The number of participants who were administered RBC transfusions during the DTP and EEP is presented.|Week 1 to Week 24|The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not.||Number of participants|||Number
764071|NCT00661505|Secondary|Number of Participants With Reports of Anti-erythropoietin Antibodies|The number of participants with Anti-epoetin antibodies is presented.|Up to Week 24|The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not.||Number of participants|||Number
764072|NCT00661505|Secondary|Number of Participants With Any Adverse Events and Serious Adverse Events|An adverse event (AE) is any untoward medical occurrence in a participant who is administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.|Up to Week 28|The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not.||Number of participants|||Number
764073|NCT00661505|Secondary|Number of Participants Taking Concomitant Medications|The number of participants taking different classes of concomitant medications at any time following enrollment into the study is presented.|Up to Week 28|The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not.||Number of participants|||Number
764084|NCT00661505|Secondary|Mean Change From Baseline in Hematocrit at Week 16 and Week 24|The hematocrit, also called packed cell volume or erythrocyte volume fraction, is the volume percentage of red blood cells in the blood. Mean change from Baseline (BL) in hematocrit was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.|BL (Week -4 to Week 0), Week 16, and Week 24|The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.||percentage of red blood cells||Standard Deviation|Mean
764074|NCT00661505|Secondary|Mean Change in From Baseline in Blood Pressure at Week 16 and Week 24|Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured before blood sampling and C.E.R.A. administration. Blood pressure was assessed both before and after the dialysis session for participants undergoing hemodialysis. Change from BL in blood pressure was calculated as the value at a specific week (W) during the study minus the BL value. The baseline was defined as Week -4 to Week 0.|Baseline (Week -4 to Week 0), Week 16, and Week 24|The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.||Millimeters of Mercury||Standard Deviation|Mean
764075|NCT00661505|Secondary|Mean Change From Baseline in Weight at Week 16 and Week 24|Mean change from BL in weight was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.|BL (Week -4 to Week 0), Week 16, and Week 24|The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.||kilogram||Standard Deviation|Mean
764076|NCT00661505|Secondary|Mean Change From Baseline in Phosphate and Potassium at Week 16 and Week 24|Mean change from BL in each parameter (phosphate and potassium) was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.|BL (Week -4 to Week 0), Week 16, and Week 24|The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.||millimole/liter||Standard Deviation|Mean
764077|NCT00661505|Secondary|Mean Change From Baseline in C-Reactive Protein at Week 16 and Week 24|Mean change from BL in C-reactive protein was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.|BL (Week -4 to Week 0), Week 16, and Week 24|The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.||milligram/liter||Standard Deviation|Mean
764078|NCT00661505|Secondary|Mean Change From Baseline in Transferrin Saturation at Week 16 and Week 24|Mean change from BL in transferrin saturation (TSAT) was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.|BL (Week -4 to Week 0), Week 16, and Week 24|The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.||Percentage of TSAT||Standard Deviation|Mean
764079|NCT00661505|Secondary|Mean Change From Baseline in Transferrin and Albumin at Week 16 and Week 24|Mean change from BL in each parameter (transferrin and albumin) was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.|BL (Week -4 to Week 0), Week 16, and Week 24|The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.||gram/liter||Standard Deviation|Mean
764080|NCT00661505|Secondary|Mean Change From Baseline in Iron, Total Iron Binding Capacity, and Creatinine at Week 16 and Week 24|Mean change from BL in each parameter [iron, total iron binding capacity (TIBC), and creatinine] was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.|BL (Week -4 to Week 0), Week 16, and Week 24|The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.||micromole/Liter||Standard Deviation|Mean
764081|NCT00661505|Secondary|Mean Change From Baseline in Ferritin at Week 16 and Week 24|Mean change from BL in ferritin was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.|BL (Week -4 to Week 0), Week 16, and Week 24|The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.||microgram/liter||Standard Deviation|Mean
764082|NCT00661505|Secondary|Mean Change From Baseline in Leucocytes and Platelet at Week 16 and Week 24|Mean change from BL in for each parameter (leucocytes and platelet) was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.|BL (Week -4 to Week 0), Week 16, and Week 24|The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.||Number of cells x 10^9/L||Standard Deviation|Mean
764083|NCT00661505|Secondary|Mean Change From Baseline in Hemoglobin at Week 16 and Week 24|Mean change from BL in hemoglobin was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.|BL (Week -4 to Week 0), Week 16, and Week 24|The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.||g/dL||Standard Deviation|Mean
764096|NCT00661570|Secondary|Reason for Replacement||At removal of prosthesis|1 patient had his Vega inappropriately removed and received a Provox2.||patients|||Number
764622|NCT00665925|Secondary|Alanine Aminotransferase (ALT) >10x Upper Limit of Normal (ULN)|The number of participants with ALT (a test of liver function) values greater than 10 times the ULN|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.||Participants|||Number
764085|NCT00661505|Secondary|Mean Change From Baseline in Erythrocyte Mean Corpuscular Volume at Week 16 and Week 24|Mean change from Baseline in erythrocyte mean corpuscular volume (MCV) was calculated as the value at a specific week during the study minus the BL value. The Baseline was defined as Week -4 to Week 0.|BL (Week -4 to Week 0), Week 16, and Week 24|The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.||Femtoliter||Standard Deviation|Mean
764086|NCT00661505|Secondary|Mean Monthly Dose of C.E.R.A. During the Dose Titration Period and Efficacy Evaluation Period|The mean monthly dose of C.E.R.A. administered during the DTP and EEP was calculated per participant and then summarized.|DTP (Week 1 to Week 16), EEP (Week 16 to Week 24)|The ITT population included participants who received at least 1 dose of C.E.R.A. at Week 0 and for whom data for at least one follow-up variable was available. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.||mcg||Standard Deviation|Mean
764087|NCT00661505|Secondary|Percentage of Participants Requiring Any Dose Adjustments in C.E.R.A. During the Dose Titration Period and Efficacy Evaluation Period|Dose adjustments were necessary when Hb increased or decreased by a clinically significant amount. The dose of C.E.R.A. was adjusted to maintain the individual participant's Hb within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.0 and 12.0 g/dL throughout the dose titration period (DTP) and the EEP (Week 1 to Week 24). The reference Hb value was taken as the time adjusted average of all Hb assessments during the SVP (Week -4 to Week 0).|DTP (Week 1 to Week 16), EEP (Week 16 to Week 24)|The ITT population included participants who received at least one dose of C.E.R.A. at Week 0 and for whom data for at least one follow-up variable was available. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.||Percentage of participants|||Number
764088|NCT00661505|Secondary|Mean C.E.R.A. Dose Required to Maintain Hemoglobin Level Within the Range 10.0-12.0 Gram/Deciliter Throughout the Efficacy Evaluation Period|The mean dose of C.E.R.A. required to maintain Hb level between 10.0-12.0 g/dL during the EEP was calculated per participant and then summarized. The EEP was defined as Week 16 to Week 24. However, C.E.R.A. was not administered at the Week 24 visit. Therefore, the time period for calculation of mean C.E.R.A. dose during EEP is from Week 16 to Week 20.|EEP (Week 16 to Week 20)|The ITT population included participants who received at least one dose of C.E.R.A. at Week 0 and for whom data for at least one follow-up variable was available. Participants with available data at the time of assessment were included in the analysis.||mcg||Standard Deviation|Mean
764089|NCT00661505|Secondary|Median Time Spent in the Hemoglobin Range 10.0-12.0 Gram/Deciliter During the Efficacy Evaluation Period|The Hb concentration was recorded for all the participants during the EEP. The median time spent (in days) by participants in the target range (10.0-12.0 g/dL) during the EEP is presented. The EEP was defined as Week 16 to Week 24.|EEP (Week 16 to Week 24)|The ITT population included participants who received at least one dose of C.E.R.A. at Week 0 and for whom data for at least one follow-up variable was available. Participants with available data at the time of assessment were included in the analysis.||days||Inter-Quartile Range|Median
764090|NCT00661505|Secondary|Percentage of Participants Maintaining Hemoglobin Concentration Within the Range of 10.0-12.0 Gram/Deciliter Throughout the Efficacy Evaluation Period|The time adjusted average Hb concentration of all the values recorded during the EEP was calculated for each participant. The percentage of participants maintaining their average Hb concentration during the EEP within the Hb concentration range of 10.0-12.0 g/dL is presented. The EEP was defined as Week 16 to Week 24.|EEP (Week 16 to Week 24)|The ITT population included participants who received at least one dose of C.E.R.A. at Week 0 and for whom data for at least one follow-up variable was available.||Percentage of participants||95% Confidence Interval|Number
764091|NCT00661505|Secondary|Mean Change in Hemoglobin Concentration Between the Stability Verification Period and the Efficacy Evaluation Period|The mean change in the time-adjusted average Hb concentration between the two study periods The Stability Verification Period (SVP) and EEP is presented. The SVP was defined as Week -4 to Week 0. The EEP was defined as Week 16 to Week 24.|SVP (Week -4 to Week 0) and EEP (Week 16 to Week 24)|The Intention to treat (ITT) population included participants who received at least one dose of C.E.R.A. at Week 0 and for whom data for at least one follow-up variable (adverse event) was available.||g/dL||Standard Deviation|Mean
764092|NCT00661505|Primary|Percentage of Participants Who Maintained Their Mean Hemoglobin Concentration Within +/- 1.0 Gram/Deciliter of Their Reference Hemoglobin Concentration and Between 10.0 and 12.0 Gram/Deciliter During the Efficacy Evaluation Period|The reference hemoglobin (Hb) value was taken as the time adjusted average of all Hb assessments during the SVP (Week -4 to Week 0). The time adjusted average Hb concentration of all the values recorded during the efficacy evaluation period (EEP) was calculated for each participant and their reference Hb concentration was subtracted from this value. The percentage of participants maintaining their average Hb concentration during the EEP within +/- 1 gram/deciliter (g/dL) of their reference Hb concentration and between the Hb range 10.0 -12.0 g/dL is presented. The EEP was defined as Week 16 to Week 24. Data missing at the end of the EEP was handled using the last value carried forward method, including any data missing due to withdrawal of participants following red blood cells (RBC) transfusion.|EEP (Week 16 to Week 24)|The per protocol (PP) population included all participants who received at least one dose C.E.R.A. and underwent a safety follow-up except who had < 3 recorded Hb values and had inadequate iron status during EEP, missed C.E.R.A administration during Weeks 16-24, and/or who withdrawn before the end of EEP.||Percentage of participants||95% Confidence Interval|Number
764093|NCT00661531|Secondary|Response Rate|Response rate was defined per RECIST version 1.0. In this study, response rate was defined as including patients with either a complete response (complete disappearance of all target lesions with changes confirmed by repeat assessments performed no less than 4 weeks after the criteria for response was first met) or a partial response (at least 30% decrease in the sum of the longest diameter of the target lesions)|6 months|||Participants|||Count of Participants
764094|NCT00661531|Primary|Progression Free Survival|Progression free survival is defined as the time from assignment of treatment to the time of disease progression or death from any cause|6 months|||Participants|||Count of Participants
764095|NCT00661544|Primary|Response Rate|Bone marrow aspirate and biopsy performed to assess complete response and overall response rate.|3, 6 and 12 months|||Participants|||Number
764097|NCT00661570|Secondary|Ease of Insertion|The Vega voice prosthesis used in this study is inserted with a new insertion tool, the SmartInserter. Physicians were asked to rate the insertion on a 4 point scale. what they thought of the new insertion tool, also in comparison to the regular tool used in the clinic, the Provox2 inserter. As the Provox voice prosthesis is a tool physicians already used, no insertions were performed with the Provox2 inserter during the study.|assessed immediately after insertion procedure|All patients included for insertion evaluation||insertions|||Number
764098|NCT00661570|Secondary|Voice Quality|Subjective patient opinion about 5 voice related items (intelligibility face to face and on the phone, loudness, pitch and fluency). The best value is 5 and the worst value is 20.|at 3 months or device change (whichever was first)|23 patients completed the structured questionnaires about the voice prosthesis. One patient received the wrong voice prosthesis after inclusion. Two patients had unsolvable leakage around the Provox Vega 20, which is 2.5 French smaller in outer diameter than their previous Provox2 voice prosthesis.||Units on a scale||Standard Deviation|Mean
764099|NCT00661570|Primary|Device Life Time|Device life was measured from the time of insertion until the time of replacement. Reason for replacement was recorded. Only replacements for leakage through the device are considered for calculation of device life time.|at replacement of voice prosthesis (maximum 1 year)|In 16 out of the 26 patients, the device was replaced for leakage through the device. These 16 devices were considered for calculation of device life time.||days of use||Full Range|Median
764100|NCT00661583|Secondary|Mean Change in Visual Acuity|Mean change in visual acuity in logMAR.|6 months|||logMAR||Full Range|Mean
764101|NCT00661583|Secondary|Mean Change in in Intraocular Pressure.|Mean change in in intraocular pressure at 3 months and at 6 months|6 months|||mmHg||Full Range|Mean
764102|NCT00661583|Secondary|Percent of Subjects With a Qualified Success and Viable Bleb at 6 Months.|To determine percent of subjects with a qualified success and viable bleb at 6 months (IOP between 6mm Hg and 22 mm Hg with pressure controlled with and without adjunctive medications)|6 months|||percentage of subjects|||Number
764103|NCT00661583|Primary|Assessment of Ocular Adverse Events|To assess ocular adverse events of combination ranibizumab and MMC therapy at 6 months|6 months|||Number of Reported Adverse Events|||Number
764104|NCT00661609|Secondary|Overall Survival (OS)|Time in weeks from the first administration of study drug to death.|Time from the first administration of study drug to disease progression or death (maximum treatment period of 309 days (44 weeks)|Of the 41 participants who received at least one dose of study medication, only 39 were evaluable for response by RECIST (excludes 2 patients who had baseline scans performed more than 28 days before dosing).||Weeks||Full Range|Median
764105|NCT00661609|Secondary|Progression Free Survival (PFS)|Time in weeks from date of first study drug administration to the date of progressive disease according to the RECIST guidelines (Response evaluation in solid tumors, version 1.0), or death due to any cause.|Time from the first administration of study drug to disease progression or death (maximum treatment period of 309 days (44 weeks)|Of the 41 participants who received at least one dose of study medication, only 39 were evaluable for response by RECIST (excludes 2 patients who had baseline scans performed more than 28 days before dosing).||Weeks||Full Range|Median
764106|NCT00661609|Secondary|Duration of Objective Tumor Response (OTR)|Time in weeks from the date of Complete Response (CR) or Partial Response (PR), whichever occurs earlier, to the date of discontinuation of study. RECIST guidelines:(Response evaluation criteria in solid tumors, version 1.0)|Time from first documentation of Complete or Partial Response, whichever occurs earlier, to discontinuation of the study drug (maximum treatment period of 309 days (44 weeks)||||||
764107|NCT00661609|Secondary|Disease Control Rate (DCR)|Percentage of participants with Complete Response (CR), Partial Response (PR), or stable disease (SD) lasting at least 8 weeks from the first administration of study drug. RECIST guidelines:(Response evaluation criteria in solid tumors, version 1.0).|8 weeks after study drug begins & every 8 weeks thereafter until discontinuation of the study ( maximum treatment period of 309 days (44 weeks)|Of the 41 participants who received at least one dose of study medication, only 39 were evaluable for response by RECIST (excludes 2 patients who had baseline scans performed more than 28 days before dosing).||Percentage of participants|||Number
764108|NCT00661609|Primary|Objective Response Rate (ORR) as Evaluated by Response Evaluation Criteria In Solid Tumors (RECIST)|Percentage of participants with complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST), version 1.0 (Therasse et al. Natl Cancer Inst 92 (2000) pp205-216).|8 weeks after study drug begins & and every 8 wks thereafter until discontinuation of study drug ( maximum treatment period of 309 days (44 weeks)|Of the 41 participants who received at least one dose of study medication, only 39 were evaluable for response by RECIST (excludes 2 patients who had baseline scans performed more than 28 days before dosing).||Percengate of participants|||Number
764109|NCT00661622|Secondary|Systemic Progression Free Survival|"Measured from the start of the treatment to confirmation of progression of disease by either imaging tests or physical examination.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of one or more new liver lesions >= 10mm in the treated lobe(s)."|Baseline to time of progression|||months||95% Confidence Interval|Median
764110|NCT00661622|Secondary|Median Progression Free Survival|"Measured from the start of the treatment to confirmation of progression of disease by either imaging tests or physical examination.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of one or more new liver lesions >= 10mm in the treated lobe(s)."|Baseline to time of progression|||months||95% Confidence Interval|Median
764111|NCT00661622|Secondary|Overall Survival|Measured from the start of the treatment to death of patients|Baseline to death|||months||95% Confidence Interval|Median
764112|NCT00661622|Primary|Overall Response Rate|Clinical response in the liver metastases will be evaluated after every two embolizations using CT scans or MRI of the abdomen. The sum of the longest diameter (LD) of up to 6 target lesions will be used to determine response. Target indicator lesions will be identified and measured as baseline prior to the first embolization. The same target lesions will then be measured 3 to 4 weeks after every two treatments. The sum of the baseline LDs will be compared to the sum of the LDs after every two treatments.|Baseline then 3 to 4 weeks after every 2 treatments|||percentage of participants||90% Confidence Interval|Number
764113|NCT00661622|Primary|Response of Liver Metastases|"Complete response: Disappearance of all target and non-target liver lesions
Partial response: >= 30% decrease in the sum of the longest diameters (LD) relative to baseline sum LD with at least stable non-target liver lesions
Stable disease: Absence of change which would qualify as response or progression
Progression: >= 20% increase in the sum LD in target liver lesions or unequivocal progression of non-target liver lesions in the treated lobe(s) or appearance of one or more new liver lesions >= 10mm in the treated lobe(s)"|Every 8 weeks|||participants|||Number
764114|NCT00661661|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to the last participants visit in the study. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for safety evaluation.|Baseline up to Week 288|Safety analysis set: all participants who received at least 1 dose of study medication in current study.||Particiants|||Number
764115|NCT00661661|Secondary|Change From Month 24 in Study A3921044 in Modified Total Sharp Score (mTSS)|mTSS = sum of erosion and Joint Space Narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score). Change: scores at observation minus score at baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented potential improvement. Month 24 (the final visit) in Study A3921044 was taken as the first visit in current study.|First visit in the study (Month 24 in Study A3921044), Weeks 24, 48, and 96|Participants who had completed Study A3921044 among all participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).||Units on a scale||Standard Error|Mean
764116|NCT00661661|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Mental|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).||Units on a scale||Standard Error|Mean
764117|NCT00661661|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Physical|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).||Units on a scale||Standard Error|Mean
764118|NCT00661661|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Mental Health|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).||Units on a scale||Standard Error|Mean
764119|NCT00661661|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Emotional|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).||Units on a scale||Standard Error|Mean
764127|NCT00661661|Secondary|Change From Baseline in Tender/Painful Joint Counts|This was carried out on 68 joints. Each joint’s response to pressure/motion was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial joints). The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).||Tender/painful joints||Standard Error|Mean
767799|NCT00691132|Secondary|Combined Effects of GSTM1 and GSTT1 Genotype on Phenethyl Isothiocyanate (PEITC)-NNK Association and on the Metabolism and Excretion of PEITC||After 5 days of treatment|||nmol/mg creatinine||95% Confidence Interval|Geometric Mean
764120|NCT00661661|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Social Functioning|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).||Units on a scale||Standard Error|Mean
764121|NCT00661661|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Vitality|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).||Units on a scale||Standard Error|Mean
764122|NCT00661661|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_General Health|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).||Units on a scale||Standard Error|Mean
764123|NCT00661661|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Bodily Pain|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).||Units on a scale||Standard Error|Mean
764124|NCT00661661|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Physical|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).||Units on a scale||Standard Error|Mean
764125|NCT00661661|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Physical Functioning|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).||Units on a scale||Standard Error|Mean
764126|NCT00661661|Secondary|Change From Baseline in Swollen Joint Counts|Sixty-six (66) joints, the same as those assessed for tenderness/pain except for the right and left hip joints, were assessed for swelling by palpation using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial joints). The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).||Swollen joints||Standard Error|Mean
764151|NCT00661713|Primary|Percentages ‘of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.|Immunogenicity was evaluated by measuring the percentage of subjects with hSBA titter >1:4 against 44/76-SL, 5/99, NZ98/254 strains at months 1, 2, 3.|Month-1, 2, 3|Analysis was performed as per the protocol dataset||percentage of Subjects||95% Confidence Interval|Number
764128|NCT00661661|Secondary|Change From Baseline in Patient Assessment of Arthritis Pain|Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) visual analogue scale (VAS), where 0 mm = no pain and 100 mm = most severe pain. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).||Units on a scale||Standard Error|Mean
764129|NCT00661661|Secondary|Change From Baseline in Physician Global Assessment of Arthritis|Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).||Units on a scale||Standard Error|Mean
764130|NCT00661661|Secondary|Change From Baseline in Patient Global Assessment of Arthritis|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS where 0 = very well and 100 = very poorly. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS)."|Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).||Units on a scale||Standard Error|Mean
764131|NCT00661661|Secondary|Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])|DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).||Units on a scale||Standard Error|Mean
764132|NCT00661661|Secondary|Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])|DAS28-4 (ESR) calculated from swollen joint count (SJC) and tender/painful joint count (TJC) using 28 joint count, erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).||Units on a scale||Standard Error|Mean
764133|NCT00661661|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, reach, grip, hygiene and common activities over past week. Each item scored on 4-point scale, 0 to 3: 0=no difficulty; 1=some difficulty;2=much difficulty; 3=unable to do. Overall score was computed as sum of domain sc ores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).||Units on a scale||Standard Error|Mean
764134|NCT00661661|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response|ACR70 response: greater than or equal to (>=) 70 percent (%) improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP). The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).||Percentage of participants|||Number
764135|NCT00661661|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response|ACR50 response: greater than or equal to (>=) 50 percent (%) improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP). The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).||Percentage of participants|||Number
764152|NCT00661726|Primary|Change in Total Hemoglobin (Hb) From Baseline to Peak (the Follow-up Time Point With the Highest Value)||up to 12 weeks|One of 6 enrolled patients withdrew from study after week 2 and was not used for analysis.||g/dL||Standard Error|Mean
768199|NCT00695318|Primary|Change From Baseline in Size of Geographic Atrophy||24 months|Patients received either a 0.2µg/Day or 0.5 µg/Day treatment in the study eye and a sham treatment in the fellow eye.||mm3/year||Standard Deviation|Mean
764136|NCT00661661|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response|ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP). The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).||Percentage of participants|||Number
764137|NCT00661674|Secondary|SOWS Score|"The SOWS score is composed of 16 subjective symptoms rated on a scale of 0 to 4 (0=not at all, 4=extremely) based on what subjects were experiencing at the time of testing. 15 minutes post naloxone administration coordinates with T = 180 (min) for the entire study session.
The highest score possible (64) would indicate that the individual was experiencing every symptom of opioid withdrawal to the fullest extent possible while the lowest score (0) would indicate that the individual was not experiencing any symptoms of opioid withdrawal.
Mean post-naloxone SOWS scores (+/- SEM) were computed for pretreatment groups: Placebo, palonosetron, and palonosetron with hydroxyzine"|Change from baseline in SOWS score at 180 minutes (15 minutes post naloxone administration)|||units on a scale (SOWS Scale)||Standard Error|Mean
764138|NCT00661674|Primary|OOWS Score|"The OOWS is a 13-item instrument documenting physically observable signs of withdrawal, which are rated as present (1) or absent (0) during the observation period. Maximum score possible = 13, minimum score possible = 0. T=15 minutes post naloxone administration coordinates with T = 180 (min) for the entire study session.
OOWS scores at T=180 is the primary outcome measure of the study compared with baseline OOWS scores at T=-30 (30 minutes prior to study medication administration). Reported time frames are in relation to time past since administration of study medications.
Mean post-Naloxone OOWS scores (+/- SEM) were determined for pretreatment groups"|Change from baseline in OOWS score at 180 minutes (15 minutes post naloxone administration)|||units on a scale (OOWS Scale)||Standard Error|Mean
764139|NCT00661687|Secondary|Lens Characteristics|Investigators evaluated study lenses, while on eye, for the number of eyes showing 100% wettability, no discoloration, none-light deposits, fully centered centration, and adequate movement.|Over all scheduled visits day 1 - 1 month|Over All Scheduled Visits, All Eligible, Dispensed Eyes||Eyes|Participants||Number
764140|NCT00661687|Secondary|LogMAR Visual Acuity|The mean distance high contrast LogMAR visual acuity (VA) score for test eyes over all visits, determined by the total number of letters correctly identified on the logMAR chart.|Mean over all visits - 1 day, 1 week, 1 month|All Eligible, Dispensed Eyes||LogMAR|Participants|Standard Deviation|Mean
764141|NCT00661687|Primary|Subjective Responses to Symptoms/Complaints|Subjective responses to symptoms/complaints on a scale 0-100, where 100 is the most favorable score. Subjects rated various aspects of lens comfort, vision, and handling. The average of each symptom/complaint over all follow-up visits was assessed as the primary endpoint.|Measured at screening/dispensing visit, 1 day, 1 week and 1 month follow-up visits|All eligible participants||Visual Analogue Scale|Participants|Standard Deviation|Mean
764142|NCT00661713|Secondary|Number of Subjects Reporting Unsolicited AEs Throughout the Study.|Safety was assessed as the number of subjects who reported unsolicited AEs throughout the study.|Throughout the study|Analysis was performed as per the safety dataset.||participants|||Number
764143|NCT00661713|Secondary|GMRs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination|Immunogenicity was evaluated by measuring the Geometric mean Ratios (GMRs) after primary and booster vaccination against 287-953Antigen|month-1, month-2, month-3, month-6 and month-7|Analysis was performed as per the protocol dataset.||Ratio||95% Confidence Interval|Geometric Mean
764144|NCT00661713|Secondary|GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination.|Immunogenicity was evaluated by measuring the Geometric mean Concentration (GMCs) after primary and booster vaccination against Antigen 287-953 Antigen.|month-1, month-2, month-3, month-6 and month-7|Analysis was performed as per the protocol dataset.||IU/ml||95% Confidence Interval|Geometric Mean
764145|NCT00661713|Secondary|Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.|Immunogenicity was evaluated by measuring the Geometric mean ratios (GMRs) after primary and booster vaccination against 44/76-SL, 5/99, NZ98/254.|month-1, month-2, month-3, month-6 and month-7|Analysis was performed as per the protocol dataset.||Ratio||95% Confidence Interval|Geometric Mean
764146|NCT00661713|Secondary|Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.|Immunogenicity was evaluated by measuring the Geometric mean titers (GMTs) after primary and booster vaccination against 44/76-SL, 5/99, NZ98/254.|month-1, month-2, month-3, month-6 and month-7|Analysis was performed as per the protocol dataset.||Titers||95% Confidence Interval|Geometric Mean
764147|NCT00661713|Secondary|Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.|Immunogenicity was evaluated by measuring the percentage of subjects with at least a fourfold rise in hSBA titer over the prevaccination and after booster vaccination against 44/76-SL, 5/99, NZ98/254 strains at month-1, month-2, month-3 and month-7.|Month-1, month-2, month-3 and month-7|Analysis was performed as per the protocol dataset.||percentage of Subjects||95% Confidence Interval|Number
764148|NCT00661713|Secondary|Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.|Immunogenicity was evaluated by measuring the percentage of subjects with hSBA titer ≥1:8 against 44/76-SL, 5/99, NZ98/254 strains.|at baseline, month-1, month-2, month-3, month-6 and month-7.|Analysis was performed as per the protocol dataset.||percentage of Subjects||95% Confidence Interval|Number
764149|NCT00661713|Secondary|Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6.|Immunogenicity was evaluated by measuring the percentage of subjects with hSBA titter >1:4 agains 44/76-SL, 5/99, NZ98/254 strains at months 6 & 7.|Month-6 & 7|Analysis was performed as per the protocol dataset.||percentage of Subjects||95% Confidence Interval|Number
764150|NCT00661713|Primary|Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination|Safety was assessed as the number of subjects who reported local and systemic reactions during day 1 to day 7 after any vaccination with rMenB+OMV|1 to 7 days after each vaccination|Analysis was performed as per the safety dataset.||participants|||Number
764155|NCT00661726|Secondary|Change in Red Blood Cell (RBC) Deformability From Baseline to Peak (the Follow-up Time Point With the Highest Value)|Deformability was assessed by ektacytometry. Normal RBC have maximal deformability, measurable by osmotic ektacytometry, at isotonicity (290 mosmol). A decrease on the Deformability Index (measured in arbitrary units) corresponds to an impairment in the cell membrane’s ability to alter its shape under stress.|up to 12 weeks|One of 6 enrolled patients withdrew from study after week 2 and was not used for analysis.||Arbitrary Units||Standard Error|Mean
764156|NCT00661726|Secondary|Change in Neutrophil Counts From Baseline to Nadir (the Follow-up Time Point With the Lowest Value)||up to 12 weeks|One of 6 enrolled patients withdrew from study after week 2 and was not used for analysis.||X (10^9)/L||Standard Error|Mean
764157|NCT00661726|Secondary|Change in Platelet Count From Baseline to Peak (the Follow-up Time Point With the Highest Value)||up to 12 weeks|One of 6 enrolled patients withdrew from study after week 2 and was not used for analysis.||X (10^9)/L||Standard Error|Mean
764158|NCT00661726|Secondary|Change in Erythropoietin Levels From Baseline to Nadir (the Follow-up Time Point With the Lowest Value)||up to 12 weeks|One of 6 enrolled patients withdrew from study after week 2 and was not used for analysis.||mIU/mL||Standard Error|Mean
764159|NCT00661726|Secondary|Change in Absolute Reticulocyte Count From Baseline to Nadir (the Follow-up Time Point With the Lowest Value)||up to 12 weeks|One of 6 enrolled patients withdrew from study after week 2 and was not used for analysis.||X (10^9)/L||Standard Error|Mean
764160|NCT00661726|Secondary|Change in Serum Lactate Dehydrogenase (LDH) From Baseline to Nadir (the Follow-up Time Point With the Lowest Value)||up to 12 weeks|One of 6 enrolled patients withdrew from study after week 2 and was not used for analysis.||U/L||Standard Error|Mean
764161|NCT00661726|Secondary|Change in Indirect Bilirubin From Baseline to Nadir (the Follow-up Time Point With the Lowest Value)||up to 12 weeks|One of 6 enrolled patients withdrew from study after week 2 and was not used for analysis.||µmol/L||Standard Error|Mean
764162|NCT00661726|Primary|Number of Evaluable Patients With an Increase From Baseline in Hemoglobin (Hb) of ≥1.5 g/dL||up to 12 weeks|One of 6 enrolled patients withdrew from study after week 2 and was not used for analysis.||participants|||Number
764163|NCT00661726|Secondary|Change in Absolute Fetal Hemoglobin (HbF) From Baseline to Peak (the Follow-up Time Point With the Highest Value)||up to 12 weeks|One of 6 enrolled patients withdrew from study after week 2 and was not used for analysis.||g/dL||Standard Error|Mean
764164|NCT00661778|Secondary|1-year Survival|The probability of surviving 1 year was estimated using the Kaplan-Meier method.|Baseline to 1 year|Per protocol population: All participants who received at least 1 dose of study medication and had no major protocol deviations.||Percentage of participants||95% Confidence Interval|Number
764165|NCT00661778|Secondary|Overall Survival|Overall survival is defined as the time from the first dose of study medication until death.|Baseline to the end of the study (up to 4 years)|Per protocol population: All participants who received at least 1 dose of study medication and had no major protocol deviations.||Months||95% Confidence Interval|Median
764166|NCT00661778|Secondary|Duration of the Objective Response|Duration of the objective response is defined as the time from a complete or partial response to disease progression or death due to disease.|Baseline to the end of the study (up to 4 years)||||||
764167|NCT00661778|Secondary|Percentage of Participants With an Objective Response|An objective response was defined as a complete or partial response determined on 2 consecutive occasions ≥ 4 weeks apart using Response Evaluation Criteria in Solid Tumors (RECIST). Complete response was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must be < 10 mm on the short axis. Partial response was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum.|Baseline to the end of the study (up to 4 years)|Evaluable population: All participants who received at least 2 treatment cycles, have had all baseline lesions assessed on at least 1 occasion after receiving the 2nd treatment cycle, and have not had any major protocol violations.||Percentage of participants|||Number
764168|NCT00661778|Primary|Progression-free Survival|Progression-free survival was defined as the time from enrollment in the study to the first documented disease progression using Response Evaluation Criteria In Solid Tumors (RECIST) or death from any cause, whichever occurred first.|Baseline to the end of the study (up to 4 years)|Per protocol population: All participants who received at least 1 dose of study medication and had no major protocol deviations.||Months||95% Confidence Interval|Median
764169|NCT00661830|Secondary|Time to Objective Response|Time to Objective Response (OR) is defined as the time from start of treatment to objective tumor response (CR or PR) is first documented according to the RECIST tumor response criteria during treatment or until 30 days after termination of active therapy. Response must subsequently be confirmed. For subjects failing to achieve an objective response and who did not progress during the trial, time to objective response will be censored at their last date of tumor evaluation.|one year|All subjects who receive at least one dose of trial treatment and had no progression during the trial are included in the analysis||days||95% Confidence Interval|Median
764170|NCT00661830|Secondary|Best Overall Response|"Best Overall Response (BOR) is defined as the best tumor response (confirmed partial or complete response, stable disease) that is achieved during treatment or within 30 days after termination of active therapy that is confirmed according to the RECIST tumor response criteria. Best response is determined from the sequence of responses assessed. For complete response (CR) or partial response (PR), best response must be confirmed by a second assessment within 4 -6 weeks.
Two objective status determinations of CR before progression are required for a best response of CR.
Two determinations of PR or better before progression, but not qualifying for a CR, are required for a best response of PR.
Best response of Stable Disease (SD) is defined as disease that does not meet the criteria of CR, PR or Progressive Disease (PD) and has been evaluated at least one time, at least 6 weeks after baseline assessment."|one year|All subjects who receive at least one dose of trial treatment are included in the analysis.||participants|||Number
764171|NCT00661830|Secondary|Overall Survival|Overall Survival (OS) is measured from start of treatment to death due to any cause until end of follow-up period. Time to last observation will be used if a patient has not died and OS for the patient will be considered censored at the date of the last observation.|one year|All subjects who receive at least one dose of trial treatment are included in the analysis||days||95% Confidence Interval|Median
772076|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 2|Subject Satisfaction - soft enough to conceal when deflated|6 months post-surgery|||% satisfactory or somewhat satisfactory|||Number
764172|NCT00661830|Primary|Progression-free Survival (PFS)|The primary endpoint is the progression-free survival (PFS) defined as the time from start of treatment to first documentation of objective tumor progression or to death due to any cause, whichever occurs first during treatment or follow-up period. For patients not known to have died as of the data cut-off date and who do not have objective progressive disease, PFS will be censored at the date of the last objective progression-free disease assessment. For patients who receive subsequent anticancer therapy (after discontinuation from the study drug) prior to objectively determined disease progression or death, PFS will be censored at the date of the last objective progression-free disease assessment prior to post-discontinuation anti-cancer therapy. Acceptable documentation of objective disease progression status consists of objective assessments using CT scan assessment method.|one year|All subjects who receive at least one dose of trial treatment are included in the analysis.||days||95% Confidence Interval|Median
764173|NCT00661895|Secondary|New Onset Diabetes Mellitus||3 month intervals||||||
764174|NCT00661895|Primary|Percentage of Subjects Achieving Blood Pressure Goals|Percentage of subjects who achieved JNC-VII defined blood pressure goals.|3 month intervals|||percentage of participants|||Number
764175|NCT00661960|Primary|the Percentage of CD3+/CD4+ Cells Per Cubic Millimeter at the Effector Sites in the Duodenal Tissues Obtained From Volunteers to the Antiretroviral Therapy Regimen Over Time.|Duodenal tissue immune cell subsets were measured by flow cytometry.|nine months|all subjects who completed all study visits||% CD3/CD4 T-cells in GALT tissue||Inter-Quartile Range|Median
764176|NCT00661999|Secondary|Transferrin Saturation at Baseline, Week 7 and Week 16||Baseline, 7 weeks and 16 weeks|||Percentage Saturation||Standard Deviation|Mean
764177|NCT00661999|Secondary|Mean Corpuscular Volume (MCV) Level at Baseline, Week 7 and Week 16|MCV is a measure of the average red blood cell volume.|Baseline, 7 weeks and 16 weeks|||fL||Standard Deviation|Mean
764178|NCT00661999|Secondary|Ferritin Level at Baseline, Week 7 and Week 16||Baseline, 7 weeks and 16 weeks|||µg/L||Standard Deviation|Mean
764179|NCT00661999|Secondary|Soluble Transferrin Receptor (sTfR)Level at Week 1, Week 7 and Week 16||1 week, 7 weeks and 16 weeks|||mg/L||Standard Deviation|Mean
764180|NCT00661999|Secondary|C-reactive Protein (CRP) Level at Week 1, Week 7 and Week 16||1 Week, 7 Weeks and 16 Weeks|||mg/L||Standard Deviation|Mean
764181|NCT00661999|Secondary|Change From Baseline in Quality of Life (QOL) Score as Measured by The Functional Assessment of Cancer Therapy-Anemia (FACT-An) at End of Study|FACT-AN Scale range: 0 (Worst) to 100 (Best), ordinal. Change: score at 16 weeks minus score at baseline. A clinically significant result will be defined as a shift of 10 points on a 0-100 point transformed scale between the average QOL scores of the 3 variants of iron therapy.|Baseline and 16 weeks|||Scores on a scale||Standard Deviation|Mean
764182|NCT00661999|Secondary|Change From Baseline in Quality of Life (QOL) Score as Measured by Brief Fatigue Inventory(BFI) Fatigue Now Scale at End of Study|Fatigue Now Scale range: 0 (No Fatigue) to 10 (Worst), ordinal. Change: score at 16 weeks minus score at baseline.|Baseline and 16 weeks|||Scores on a scale||Standard Deviation|Mean
764183|NCT00661999|Secondary|Change From Baseline in Quality of Life (QOL) Score as Measured by Symptom Distress Scale (SDS) at End of Study|SDS Scale range: 0 (Worst), 100 (Best), ordinal. Change: score at 16 weeks minus score at baseline. A clinically significant result will be defined as a shift of 10 points on a 0-100 point transformed scale between the average QOL scores of the 3 variants of iron therapy.|Baseline and 16 weeks|||Scores on a scale||Standard Deviation|Mean
764184|NCT00661999|Secondary|Change From Baseline in Overall Quality of Life (QOL) Score as Measured by the Linear Analogue Self Assessment (LASA)|Overall QOL item score range: 0 (Worst) to 10 (Best), ordinal. Change: score at 16 weeks minus score at baseline.|Baseline and 16 weeks|||Scores on a scale||Standard Deviation|Mean
764185|NCT00661999|Secondary|Time to First Red Blood Cell (RBC) Transfusions||16 weeks|Only 63 participants (20 DA + IV Iron, 21 DA + Oral Iron and 22 DA + Placebo) needed RBC transfusion during 16 weeks of treatment period. Thus, median of time to first RBC transfusion and 95 % confidence interval are not attainable.||Days||95% Confidence Interval|Median
764186|NCT00661999|Secondary|Time to Hematopoietic Response|Hematopoietic response was defined as Hb increment of 2.0 g/dL from baseline or achievement of Hb >= 11 g/dL (whichever occurs first) in the absence of red blood cell transfusions during the preceding 28 days during the treatment period.|16 weeks|||Days||95% Confidence Interval|Median
764187|NCT00661999|Secondary|Mean Increment in Hemoglobin Level at Week 16|Value at 16 weeks minus value at baseline.|Baseline and 16 weeks|||g/dL||Standard Deviation|Mean
764188|NCT00661999|Secondary|Mean Increment in Hemoglobin Level at Week 7|Value at 7 weeks minus value at baseline.|Baseline and 7 weeks|||g/dL||Standard Deviation|Mean
764189|NCT00661999|Secondary|Incidence of Patients Receiving at Least One Red Blood Cell (RBC) Transfusions||Week 1 to Week 16|||Participants|||Number
764190|NCT00661999|Secondary|Percentage of Patients Maintaining an Average Hemoglobin Level Within the National Comprehensive Cancer Network (NCCN) Range (11-13 g/dL) Through Week 16, Once Achieving a Hemoglobin of ≥ 11 g/dL||16 Weeks|||Percentage of Participants|||Number
764191|NCT00661999|Primary|Hematopoietic Response Rate Defined as the Number of Participants Who Exhibit a Hematopoietic Response|Hematopoietic response was defined as Hemoglobin (Hb) increment of 2.0 g/dL from baseline or achievement of Hb >= 11 g/dL (whichever occurs first) in the absence of red blood cell transfusions during the preceding 28 days during the treatment period.|16 Weeks|||Participants|||Number
764192|NCT00662012|Secondary|Improvement of Lesions, Resolution of Fever and Lab Abnormalities for Visceral Leishmaniasis and Regression of Mucosal Lesions .|Improvement of lesions for cutaneous leishmanias, resolution of fever and lab abnormalities for visceral leishmaniasis and regression of mucosal lesions for mucocutaneous disease.|5 years|Analysis per protocol||participants|||Number
764193|NCT00662012|Primary|The Primary Safety Endpoint - Frequency of Complications of Therapy|The primary safety endpoint is the frequency of complications of therapy|5 years|Analysis was per protocol||participants|||Number
764194|NCT00662025|Secondary|t1/2 for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU)|t1/2 means a terminal phase half-life. 5'-DFCR = 5'-deoxy-5-fluorocytidine, 5'-DFUR = 5'-deoxy-5-fluorouridine, 5-FU = 5-fluorouracil|Day 14 of Cycle 1|"Pharmacokinetic parameters are estimated for the initial 6 participants (Cohort 1).
n=Number of participants with analyzable data."||hours||Standard Deviation|Mean
772077|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 2|Subject Satisfaction - soft enough to conceal when deflated|3 months post-surgery|||% satisfactory or somewhat satisfactory|||Number
764195|NCT00662025|Secondary|AUC(0-inf) for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU)|"AUC(0-inf) means an area under the plasma concentration time curve from time zero to Infinity.
5'-DFCR = 5'-deoxy-5-fluorocytidine, 5'-DFUR = 5'-deoxy-5-fluorouridine, 5-FU = 5-fluorouracil"|Day 14 of Cycle 1|"Pharmacokinetic parameters are estimated for the initial 6 participants(Cohort 1).
n=Number of participants with analyzable data."||nanogram∙hour/milliliter||Standard Deviation|Mean
764196|NCT00662025|Secondary|Cmax for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU)|Cmax means a maximum observed plasma concentration. 5'-DFCR = 5'-deoxy-5-fluorocytidine, 5'-DFUR = 5'-deoxy-5-fluorouridine, 5-FU = 5-fluorouracil|Day 14 of Cycle 1|Pharmacokinetic parameters are estimated for the initial 6 subjects (Cohort 1). n=Number of subjects with analyzable data.||nanogram/milliliter||Standard Deviation|Mean
764197|NCT00662025|Secondary|Tmax for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU)|"Tmax means a time to first occurrence of maximum observed plasma concentration (Cmax).
5'-DFCR = 5'-deoxy-5-fluorocytidine, 5'-DFUR = 5'-deoxy-5-fluorouridine, 5-FU = 5-fluorouracil"|Day 14 of Cycle 1|"Pharmacokinetic parameters are estimated for the initial 6 participants (Cohort 1).
n=Number of participants with analyzable data."||hours||Full Range|Median
764198|NCT00662025|Secondary|AUC(0-24) for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662)|"SU012662 is a metabolite of sunitinib. AUC(0-24) means an area under the plasma concentration time curve from time zero to 24 hours post-dose.
The AUC(0-24) for total drug (sunitinib+SU012662) was calculated as the mean of the AUC(0-24) of total drug from individual participant."|Days 14 and 15 of Cycle 1|Pharmacokinetic parameters are estimated for the initial 6 participants (Cohort 1).||nanogram∙hour/milliliter||Standard Deviation|Mean
764199|NCT00662025|Secondary|Cmax for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662)|"SU012662 is a metabolite of sunitinib. Cmax means a maximum observed plasma concentration.
The Cmax for total drug (sunitinib+SU012662) was calculated as the mean of the Cmax of total drug from individual participant."|Days 14 and 15 of Cycle 1|Pharmacokinetic parameters are estimated for the initial 6 participants (Cohort 1).||nanogram/milliliter||Standard Deviation|Mean
764200|NCT00662025|Secondary|Tmax for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662)|"SU012662 is a metabolite of sunitinib. Tmax means a time to first occurrence of maximum observed plasma concentration (Cmax).
The Tmax for total drug (sunitinib+SU012662) was calculated as the median of the Tmax of total drug from individual participant."|Days 14 and 15 of Cycle 1|Pharmacokinetic parameters are estimated for the initial 6 participants (Cohort 1).||hours||Full Range|Median
764201|NCT00662025|Secondary|Trough Plasma Concentration (Ctrough) for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662)|"SU012662 is a metabolite of sunitinib. Trough plasma concentration (Ctrough) means the concentration prior to study drug administration.
The Ctrough for total drug (sunitinib+SU012662) was calculated as the mean of the Ctrough of total drug from individual participant."|Days 14 and 15 of Cycle 1|Pharmacokinetic parameters are estimated for the initial 6 participants (Cohort 1).||nanogram/milliliter||Standard Deviation|Mean
764202|NCT00662025|Secondary|Overall Survival (OS)|OS is defined as the time from the start of study treatment to death due to any cause. OS data is censored on the last day they were known to be alive in the absence of confirmation of death.|A survival survey was conducted at least every 6 months after the completion of study treatment or withdrawal from the study.|FAS is defined as the population of all participants who are diagnosed as having advanced/metastatic breast cancer and received at least one dose of study medication.||months||Full Range|Median
764203|NCT00662025|Secondary|Time to Objective Tumor Response (TTR)|Based on Data Review Committee's Assessment. TTR is defined as the time from the start of study treatment to first documentation of objective tumor response (confirmed CR or PR). CR is defined as disappearance of all target and non-target lesions. PR is defined as ≥30% decrease in sum of the LDs of the target lesions taking as reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat evaluation ≥4 weeks after initial documentation of response.|Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8. Up to 28 days after the last administration of the study drug.|"FAS is defined as the population of all participants who are diagnosed as having advanced/metastatic breast cancer and received at least one dose of study medication.
Twenty three participants with objective tumor response were analyzed for TTR."||months||95% Confidence Interval|Median
764204|NCT00662025|Secondary|Duration of Objective Tumor Response (DR)|Based on Data Review Committee's Assessment. DR is defined as the time from the first documentation of objective tumor response (confirmed CR or PR) to the first documentation of disease progression or to death due to cancer, whichever occurred first. CR is defined as disappearance of all target and non-target lesions. PR is defined as ≥30% decrease in sum of the LDs of the target lesions taking as reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat evaluation ≥4 weeks after initial documentation of response.|Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8. Up to 28 days after the last administration of the study drug.|"FAS is defined as the population of all participants who are diagnosed as having advanced/metastatic breast cancer and received at least one dose of study medication.
Nineteen participants with objective tumor response were analyzed for DR."||months||95% Confidence Interval|Median
764205|NCT00662025|Secondary|Time to Tumor Progression (TTP)|Based on Data Review Committee's Assessment. TTP is defined as the time from the start of study treatment to first documentation of objective tumor progression.|Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8. Up to 28 days after the last administration of the study drug.|FAS is defined as the population of all enrolled patients who are diagnosed as having advanced/metastatic breast cancer and received at least one dose of study medication.||months||95% Confidence Interval|Median
764206|NCT00662025|Secondary|Progression-Free Survival (PFS)|Based on Data Review Committee's Assessment. PFS is defined as the time from the start of study treatment to first documentation of objective tumor progression, or to death on study due to any cause, whichever occurred first.|Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8. Up to 28 days after the last administration of the study drug.|FAS is defined as the population of all participants who are diagnosed as having advanced/metastatic breast cancer and received at least one dose of study medication.||months||95% Confidence Interval|Median
764623|NCT00665925|Secondary|Alanine Aminotransferase (ALT) >5-10x Upper Limit of Normal (ULN)|The number of participants with ALT (a test of liver function) values greater than 5 to 10 times the ULN|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.||Participants|||Number
764207|NCT00662025|Secondary|Number of Subjects With CBR Based on Investigator's Assessment|Number of participants with confirmed CR, PR or SD for at least 24 weeks on study according to RECIST. CR is defined as disappearance of all target and non-target lesions. PR is defined as ≥30% decrease in sum of the LDs of the target lesions taking as a reference the baseline sum LD according to RECIST. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference smallest sum of LDs since treatment started.|Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of study.|FAS is defined as the population of all participants who are diagnosed as having advanced/metastatic breast cancer and received at least one dose of study medication.||participants|||Number
764208|NCT00662025|Secondary|Number of Participants With Clinical Benefit Response (CBR) Based on Data Review Committee's Assessment|Number of participants with confirmed CR, PR or stable disease (SD) for at least 24 weeks on study according to RECIST. CR is defined as disappearance of all target and non-target lesions. PR is defined as ≥30% decrease in sum of the LDs of the target lesions taking as a reference the baseline sum LD according to RECIST. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference smallest sum of LDs since treatment started.|Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8.|FAS is defined as the population of all participants who are diagnosed as having advanced/metastatic breast cancer and received at least one dose of study medication.||participants|||Number
764209|NCT00662025|Secondary|Number of Participants With Objective Response Based on Investigator's Assessment|Number of participants with objective response based on assessment of confirmed CR or confirmed PR according to RECIST. CR is defined as disappearance of all target and non-target lesions. PR is defined as ≥30% decrease in sum of the LDs of the target lesions taking as reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat evaluation ≥4 weeks after initial documentation of response.|Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of study.|FAS is defined as the population of all participants who are diagnosed as having advanced/metastatic breast cancer and received at least one dose of study medication.||participants|||Number
764210|NCT00662025|Primary|Number of Participants With Objective Response Based on Data Review Committee's Assessment|Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST). CR is defined as disappearance of all target and non-target lesions. PR is defined as ≥30% decrease in sum of the longest dimensions (LDs) of the target lesions taking as reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat evaluation ≥4 weeks after initial documentation of response.|Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8.|Full Analysis Set (FAS) is defined as the population of all participants who are diagnosed as having advanced/metastatic breast cancer and received at least one dose of study medication.||participants|||Number
764211|NCT00662038|Primary|Percentage of Participants With Adverse Events|An adverse event defined as any unfavorable, harmful, or pathologic change in a research participant administered a pharmaceutical study treatment as indicated by physical signs, symptoms, and/or clinically significant laboratory abnormalities that occurred during the treatment and the post-treatment period, regardless of suspected cause.|7.5 years|All participants who received any pirfenidone.||percentage of participants|||Number
764212|NCT00662129|Secondary|Quality of Life, as Measure by the Mean Change in FACT-B TOI Score at Cycle 8|"Quality of life (QOL) as measured by the mean change (from baseline) in FACT-B (TOI) Trial Outcome Index at Cycle 8 (24 weeks). FACT-B was scored according to the published scoring (*) criteria with higher scores representing better QOL. The FACT-B TOI was the sum of the following FACT-B subscale/scale scores: physical (score range 0-28), functional (score range 0-28), and Breast Cancer Subscale (score range 0-40); range of the FACT-B TOI is 0-96 (the change scores have a possible range of -96 to 96). The mean change and 95% confidence interval are reported below. A one-sample t-test is used to compare the change from baseline to a value of 0.
(*)= Brady MJ, Cella DF, Mo F, Bonomi AE, Tulsky DS, Lloyd SR, Deasy S, Cobleigh M, Shiomoto G. Reliability and validity of the Functional Assessment of Cancer Therapy-Breast (FACT-B) quality of life instrument. J Clin Oncol 1997;15:974-986."|From baseline to end of Cycle 8; Up to 24 weeks|Of the participants evaluable for primary analysis, the Overall Number of Participants Analyzed reflects the number of subjects evaluable for this secondary outcome (with a FACT-B Trial Outcome Index score at baseline and at Cycle 8).||units on a scale||95% Confidence Interval|Mean
764213|NCT00662129|Secondary|Time to Treatment Failure|Time to treatment failure is defined to be the time from the date of registration to the date at which the patient is removed from treatment due to progression, adverse events, or refusal. If the patient is considered to be a major treatment violation or is taken off study as a non-protocol failure, the patient will be censored on the date they were removed from treatment. The distribution of time to treatment failure will be estimated using the method of Kaplan-Meier (1958). Progression is defined using the RECIST Criteria, as at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, appearance of one or more new lesions, or unequivocal progression of existing non-target lesions.|Up to 5 years|The ineligible patient was included in the final analysis with participants who completed the study as specified in the Participant Flow.||months||95% Confidence Interval|Median
764214|NCT00662129|Secondary|Duration of Response|Duration of response is defined for all evaluable patients who have achieved a confirmed response as the date at which the patient’s earliest best objective status is first noted to be either a CR or PR to the earliest date progression is documented. If a patient dies subsequent to the confirmed response without a documentation of disease progression, the patient will be considered to have had disease progression at the time of their death. In the case of a patient failing to return for evaluations before a documentation of disease progression, the patient will be censored for progression on the date of last evaluation. The distribution of duration of response will be estimated using the method of Kaplan-Meier (1958).|Up to 5 years|||months||95% Confidence Interval|Median
764381|NCT00663169|Secondary|Change in Serum Amyloid A Protein (SAA) From Baseline at Month 4|Blood was collected at Baseline and Month 4 for SAA to identify the presence of inflammation, to determine its severity, and to monitor response to treatment. A negative change from baseline indicates improvement.|Baseline, Month 4|Pharmacodynamic set included all randomized patients with evaluable (or complete) pharmacodynamic parameter data.||mg/L||Standard Deviation|Mean
764215|NCT00662129|Secondary|Confirmed Response (Complete or Partial Response) Rate|A confirmed response is defined to be either a complete response (CR) or partial response (PR) noted as the objective status on 2 consecutive evaluations at least 8 weeks apart. The confirmed response rate (percentage) will be estimated by the number of confirmed responses in evaluable patients divided by the total number of evaluable patients multiplied by 100. The appropriate confidence interval will be calculated based on the binomial distribution.|Up to 5 years|The ineligible patient was included in the final analysis with participants who completed the study as specified in the Participant Flow.||percentage of patients with CR or PR||95% Confidence Interval|Number
764216|NCT00662129|Secondary|PFS Time|Progression-free survival time is defined as the time from registration to the earliest date of documentation of disease progression. If a patient dies without a documentation of disease progression the patient will be considered to have had disease progression at the time of their death. The distribution of time to progression will be estimated using the method of Kaplan-Meier (1958). Progression is defined using the RECIST Criteria, as at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, appearance of one or more new lesions, or unequivocal progression of existing non-target lesions.|Up to 5 years|The ineligible patient was included in the final analysis with participants who completed the study as specified in the Participant Flow.||months||95% Confidence Interval|Median
764217|NCT00662129|Secondary|Overall Survival Time|Overall Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier (1958).|Up to 5 years|The ineligible patient was included in the final analysis with participants who completed the study as specified in the Participant Flow.||months||95% Confidence Interval|Median
764218|NCT00662129|Primary|6-month Progression-free Survival (PFS) Rate|The primary endpoint of this trial is the 6-month progression-free survival rate. A patient is considered to be a 6-month progression-free survivor if the patient is 6 months from registration without a documentation of disease progression (note, the patient need not be on study treatment at 6 months to be considered a success). The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated using the properties of the binomial distribution. Progression is defined using the RECIST Criteria, as at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, appearance of one or more new lesions, or unequivocal progression of existing non-target lesions.|at 6 months|The ineligible patient was included in the final analysis with participants who completed the study as specified in the Participant Flow.||proportion of patients progression-free||95% Confidence Interval|Number
764219|NCT00662155|Primary|Overall Average Sleep Efficiency (%)|The standard measure for clinical trials research in insomnia is the sleep diary. This prospective self-report measurement tool provides an assessment of sleep efficiency (total sleep time/time in bed x 100) as a function of treatment.|12-week average during Phase 3|These were participants that meant compliance criteria and were included in all analyses.||percent sleep efficiency||Standard Error|Mean
764220|NCT00662155|Primary|Overall Average Sleep Continuity Profile|The standard measure for clinical trials research in insomnia is the sleep diary. This prospective self-report measurement tool provides an assessment of sleep continuity as a function of treatment.|12-week average during Phase 3|These were participants that meant compliance criteria and were included in all analyses.||minutes||Standard Error|Mean
764221|NCT00662207|Primary|Number of Participants With a Urethral Sphincter Contractions||3 hour recording session|||participants|||Number
764222|NCT00662207|Primary|Number of Participants With a Change in Anal Sphincter Pressure|Measured via balloon catheter|3 hour recording session|||participants|||Number
764223|NCT00662207|Primary|Number of Participants With a Change in External Urethral Pressure|Measured via balloon catheter|3 hour recording session|||participants|||Number
764224|NCT00662207|Primary|Number of Participants With a Change in Bladder Pressure|Measured via pressure catheter in bladder with a pressure transducer|3 hour recording session|||participants|||Number
764225|NCT00662311|Secondary|Safety and Toxicity of Vorinostat at the MTD as Assessed by NCI CTCAE Version 3.0|Count of participants with a grade 3 or higher toxicity. Toxicities were assessed using the NCI CTCAE (v3.0). Grade 3 or higher toxicities were considered worse.|Weekly during treatment, 30 days post-treatment, and 12 weeks post-treatment|||Participants|||Count of Participants
764226|NCT00662311|Secondary|Overall Survival|Kaplan-Meier estimate|1 year|||survival probability||95% Confidence Interval|Number
764227|NCT00662311|Secondary|Progression-free Survival|Kaplan-Meier estimate. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0).|1 year|||progression free survival probability||95% Confidence Interval|Number
764228|NCT00662311|Secondary|Duration of Response||Up to 3 years|||months||Full Range|Median
764229|NCT00662311|Secondary|Radiological Response Rate as Assessed by CT|Count of participants with stable disease or partial response. Patients were evaluated for treatment response per RECIST criteria (version 1.0).|12 weeks post-treatment, then every 3 months for 2 years, and then every 6 months for a year thereafter|||Participants|||Count of Participants
764230|NCT00662311|Primary|MTD of Vorinostat When Administered in Combination With Paclitaxel and Radiotherapy Therapy as Assessed by NCI Common Toxicity Criteria for Adverse Events (CTCAE) Version 3.0 (Phase I)|Defined as the highest dose level at which no more than 1 of 6 patients experiences dose-limiting toxicity (DLT). Toxicity was graded according to the National Institutes of Health Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. A DLT was defined as any Grade 3 or higher non-hematologic adverse event with the exception of alopecia, fatigue, or anorexia. Nausea and/or vomiting that persisted > 48 hours despite optimal medical management at grade 3 or higher was considered a DLT. Hematologic dose-limiting toxicity was defined as either: Grade 4 neutropenia lasting for ≥ 7 days in duration, Grade > 3 febrile neutropenia with/without infection, Grade 4 thrombocytopenia or Grade 5 hematologic toxicity.|8 weeks|||mg|||Number
764231|NCT00662363|Primary|Change in Patient Assessment of Constipation - Quality of Life|The second component of the PAC is the quality of life (QOL) component.The quality of life (QOL) component consists of five items that are rated on a 0-4 scale with higher scores indicating better QOL. Scores within the domains are averaged.|Baseline and day 7|intention to treat||units on a scale||Standard Deviation|Mean
764232|NCT00662363|Primary|Change in Patient Assessment of Constipation (PAC) - Symptoms (Sym)|Patient Assessment of Constipation (PAC) – Change in this measure was assessed. The PAC has previously been found to be a valid and reliable way to measure constipation symptoms and clinical course. The PAC has two components. The symptom (SYM) component is composed of 12 items with score range 0-4 with lower scores indicating improvement. Scores within the two domains were separately averaged. The PAC-SYM questionnaire has shown good concurrent and clinical validity for opioid-induced constipation in a number of pain populations and has demonstrative responsiveness to treatment. There are three symptom domains within the PAC-SYM: Abdominal symptoms (4 items), rectal symptoms (3 items) and stool symptoms (5 items).|Baseline and Day 7, after treatment completed (6 days of treatment)|All subjects randomized and who had baseline and endpoint data were included in the intention to treat analysis.||units on a scale||Standard Deviation|Mean
764233|NCT00662389|Primary|Serious Adverse Events|Number of Serious Adverse Events|Immediate|||Number of Serious Adverse Events|||Number
764234|NCT00662532|Secondary|BOP Percent Reduction From Baseline|Bleeding on Probing (BOP) percentage is calculated as the number of implant sites with bleeding divided by the number of implant sites per subject times 100% at each visit; reduction of BOP percentage is the BOP percentage at baseline minus the BOP percentage post-baseline|at Day 90 and Day 180|ITT||Percentage of Participants||Standard Deviation|Least Squares Mean
764235|NCT00662532|Secondary|Initial PD Reduction|Mean reduction of probing depth (PD) of qualified implant sites is derived by calculating the change of PD per qualified implant site (PD at baseline minus PD at post-baseline), and then averaging the site-specific PD changes per subject|Baseline to Day 90|||mm||Standard Deviation|Mean
764236|NCT00662532|Primary|Overall PD Reduction|Mean reduction of probing depth (PD) of qualified implant sites is derived by calculating the change of PD per qualified implant site (PD at baseline minus PD at post-baseline), and then averaging the site-specific PD changes per subject|Baseline to Day 180|||mm||Standard Deviation|Mean
764237|NCT00662545|Secondary|HIV RNA < 75 Copies/ml||entry, week 12, and week 24|||participants|||Number
764238|NCT00662545|Secondary|Incidence of ALT Flares|ALT flare: sudden increase in blood level of alanine transaminase (ALT)|every 4 weeks for 24 weeks|||participants|||Number
764239|NCT00662545|Secondary|Incidence of New Hepatic Decompensation( Ascites, Variceal Hemorrhage, Encephalopathy)||every 4 weeks for 24 weeks|||participants|||Number
764240|NCT00662545|Secondary|Incidence of Permanent Discontinuation Due to Toxicity||24 weeks|||participants|||Number
764241|NCT00662545|Primary|Hepatitis B Virus (HBV) DNA|HBV DNA carries the genetic blueprint of the virus. How many HBV DNA “particles” or “copies” are found in the blood indicates how rapidly the virus is reproducing in the liver.|week 24|||log 10 IU/ml||Full Range|Median
764242|NCT00662558|Secondary|Chronic Low Back Pain Responders Based on VAS, Patient's Global, and RMDQ|Subjects were successful responders if they had: > = 30% improvement from baseline to final visit in VAS assessment (as identified by 100 millimeter scale); > = 30% improvement from baseline to final visit in Patient's Global assessment (classified as improved if assessment reduced at least 2 grades from baseline or if assessment changed to Grade 1, worsened if assessment increased at least 2 grades from baseline or if assessment changed to Grade 5, or no change; and < 20% worsening from baseline to final visit in RMDQ assessment (lower scores indicated greater disability).|Week 6/ET|ITT||participants|||Number
764243|NCT00662558|Secondary|Patient's Satisfaction Questionnaire (With Walking and Bending Ability Scale)|Number of subjects at varying levels of pain relief (1 = very dissatisfied to 10 = very satisfied).|Week 6/ET|ITT. Number of subjects with Patient's Satisfaction Questionnaire (with walking and bending ability scale) scores at Week 6/ET: celecoxib n=373, tramadol HCl n=364.||participants|||Number
764244|NCT00662558|Secondary|Patient's Satisfaction Questionnaire (With Pain Relief Scale)|Number of subjects at varying levels of pain relief (1 = very dissatisfied to 10 = very satisfied).|Week 6/ET|ITT. Number of subjects with Patient's Satisfaction Questionnaire (with pain relief scale) scores at Week 6/ET: celecoxib n=373, tramadol HCl n=364.||participants|||Number
764245|NCT00662558|Secondary|Patient's Global Evaluation of Study Medication|Number of subjects with an overall response to study medication of poor, fair, good, very good, and excellent.|Weeks 1, 3, and 6/ET|ITT.||participants|||Number
764246|NCT00662558|Secondary|Change From Baseline in Work Limitations Questionnaire (WLQ)|The WLQ included the following: Time Scale, Physical Scale, Output Scale, Mental-Interpersonal Scale, and Index Scale. The scales ranged from 0 (Limited none of the time) to 100 (Limited all of the time). A negative change indicated subject improvement.|Baseline, Week 6/ET|ITT. Number of subjects with WLQ scores at Baseline and Week 6/ET: n=celecoxib, tramadol HCl.||scores on a scale||Standard Error|Mean
764247|NCT00662558|Secondary|Number of Subjects With Change From Baseline in MOS Optimal Sleep Scale Scores|The Optimal Scale is scaled from 0 or 1 with 1 indicating 7 or 8 hours of sleep per night and 0 otherwise. Number of subjects with change of improvement (0 to 1), no change (1 to 1 or 0 to 0), or worsening (1 to 0) from baseline as indicated by the MOS Optimal sleep scale.|Baseline, Week 6/ET|ITT. Number of subjects with MOS Optimal sleep scale scores at Week 6/ET: celecoxib n=373, tramadol HCl n=365.||participants|||Number
764248|NCT00662558|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale|MOS sleep scale included the following attributes: sleep disturbance, snoring, awaken shortness of breath or headache, quantity of sleep, sleep adequacy, somnolence, Sleep Problem Index I, and Sleep Problem Index II. Score ranged from 0-100, with a higher score indicating more of the scale attribute (e.g., more sleep disturbance, etc.). A negative change indicated subject improvement. MOS sleep scale: Change = mean score at Week 6/ET minus mean score at Baseline.|Baseline, Week 6/ET|ITT. Number of subjects with MOS scores at Baseline and Week 6/ET: n=celecoxib, tramadol HCl.||scores on a scale||Standard Error|Mean
764249|NCT00662558|Secondary|Change From Baseline in Modified Brief Pain Inventory (m-BPI-sf)|m-BPI-sf scale assessed pain severity (0 = no pain to 10 = worst possible pain), and pain interference of functional activities (0 = does not interfere to 10 = completely interferes) during the 24 hour follow-up period. Subjects indicated: how much pain now; worst pain; average level of pain; how much pain interfered with general activity, mood, walking ability, relations with other people, sleep, normal work (including housework), and enjoyment of life. m-BPI-sf: Change = mean score at Week 6/ET minus mean score at Baseline.|Baseline, Week 6/ET|ITT. Missing values were imputed by LOCF. Number of subjects with m-BPI-sf scores at Baseline and Week 6/ET: celecoxib n=373, tramadol HCl n=367.||scores on a scale||Standard Error|Mean
764250|NCT00662558|Secondary|Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score|Each subject assessed his/her own disability due to low back pain using the RMDQ worksheet, which consisted of 24 statements of disability. The RMDQ total score was calculated as the total number of statements that were checked; the RMDQ total scores could have ranged from 0 to 24, with higher scores indicating greater disability. RMDQ: Change = mean score at Week 6/ET minus mean score at Baseline.|Baseline, Week 6/ET|ITT. Missing values were imputed by LOCF. Number of subjects with Roland-Morris Disability total scores at Baseline and Week 6/ET= celecoxib n=391, tramadol n=389.||scores on a scale||Standard Error|Mean
764251|NCT00662558|Secondary|Physician's Global Assessment of Disease Activity|"Number of subjects with a physician's grading of disease activity using the Physician’s Global Assessment of Disease Activity 5-point scale ((1=very good, 2=good, 3=fair, 4=poor, and 5=very poor). Subjects were classified as Improved if their assessment reduced at least 2 grades from baseline or if their assessment changed to Grade 1 (Very Good). Subjects were classified as Worsened if their assessment increased at least 2 grades from baseline or if their assessment changed to Grade 5 (Very Poor). Subjects were classified as No Change otherwise."|Week 6/ET|ITT. Number of subjects with Physician's Global Assessment of Disease Activity scores at Week 6/ET: celecoxib n=368, tramadol HCl n=361.||participants|||Number
764252|NCT00662558|Secondary|Patient's Global Assessment of Disease Activity|"Number of subjects with a graded level of disease activity using the Patient’s Global Assessment of Disease Activity 5-point scale (1=very good, 2=good, 3=fair, 4=poor, and 5=very poor). Subjects were classified as Improved if their assessment reduced at least 2 grades from baseline or if their assessment changed to Grade 1 (Very Good). Subjects were classified as Worsened if their assessment increased at least 2 grades from baseline or if their assessment changed to Grade 5 (Very Poor). Subjects were classified as No Change otherwise."|Week 6/ET|ITT. Number of subjects with Patient's Global Assessment of Disease Activity scores at Week 6/ET: celecoxib n=375, tramadol HCl n=367.||participants|||Number
764253|NCT00662558|Secondary|Change From Baseline in Severity of Low Back Pain as Measured by Visual Analogue Scale (VAS)|VAS was a 100 millimeter (mm) scale that subjects used to assess the severity of their lower back pain. Based on the following question, “During the past day, how much back pain did you have?”, the subject was instructed to place a vertical line on the VAS to indicate the magnitude of his/her lower back pain. 0 mm = no pain and 100 mm = worst possible pain. VAS: Change = mean score at Week 6/ET minus mean score at Baseline.|Baseline, Week 6/ET|ITT. Missing values were imputed by LOCF. Number of subjects with VAS scores at Baseline and Week 6/ET: celecoxib n=386, tramadol HCl n=385.||mm||Standard Error|Mean
764254|NCT00662558|Secondary|Change From Baseline in Severity of Chronic Low Back Pain as Measured by NRS-Pain|NRS-Pain scale assessed the severity of a subject's lower back pain on a scale of 0 (No pain) and 10 (Worst possible pain). NRS-Pain scale: Change = mean score at Week 6/ET minus mean score at Baseline.|Baseline, Week 6/ET|ITT. Missing values were imputed by LOCF. Number of subjects with NRS-Pain scale scores at Baseline and Week 6/ET: celecoxib n=386, tramadol HCl n=385.||scores on a scale||Standard Error|Mean
764255|NCT00662558|Primary|Treatment Responders Based on the Numerical Rating Scale-Pain (NRS-Pain)|A subject who met the following criteria was considered as a successful responder at Week 6: completed 6 weeks of treatment with study medication and had a 30% improvement from Baseline to Week 6/ET on the NRS-Pain. NRS-Pain scale assessed the severity of a subject's lower back pain on a scale of 0 (No pain) and 10 (Worst possible pain).|Week 6 or Early Termination (ET)|Intent-to-treat = all subjects who were randomized and received at least one dose of study medication. Missing values were imputed using last observation carried forward (LOCF).||participants|||Number
764256|NCT00662649|Secondary|Time to First 3-month Confirmed Disability Progression up to End of Study Based on Expanded Disability Status Scale (EDSS): Kaplan-Meier Estimate of Percentage of Patients Free of Disability Progression|Kurtzke’s Expanded Disability Status Scale (EDSS) is a scale for assessing neurologic impairment in multiple sclerosis (MS) includes a series of scores in each of eight functional systems such as Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel & Bladder, Cerebral, and Other. The EDSS steps range from 0 (normal) to 10 (death due to MS). The Kaplan-Meier estimates of the percentage of participants free of disability progression at end of study and their 95% CIs were provided for each treatment group.|Core baseline to end of study (maximum up to 60 months)|Core intent-to-treat (ITT) population: All patients who were randomized in the Core study and received at least 1 dose of Core study drug.||Percentage of patients||95% Confidence Interval|Number
764257|NCT00662649|Secondary|Percent Change in Brain Volume From Month 0 End of Study (Core and Extension Study)|Calculations of brain volume change were performed using the structural image evaluation of normalized atrophy (SIENA), software included in the Functional Magnetic Resonance Imaging of the Brain (FMRIB) software library. SIENA is a fully automated method for estimating temporal brain volume change.|Months 0 to end of study (maximum up to 60 months)|Core intent-to-treat (ITT) population: All patients who were randomized in the Core study and received at least 1 dose of Core study drug. This analysis included only patients with value at both core baseline and end of study.||Percent change||Standard Deviation|Mean
764258|NCT00662649|Primary|Change (Expressed as Ratio) in the Annualized Aggregate Relapse Rate (ARR) From Months 0-24 (Core Study) to Months 24-48 (Extension Study)|ARR is defined as the number of confirmed relapses in a year. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. The annualized ARR for each treatment group was the mean of the annualized ARRs for all patients in the group, calculated as the total number of confirmed relapses divided by the total number of days on study multiplied by 365.25.|Months 0-24 (core study) and Months 24-48 (extension study)|Extension intent-to-treat (ITT) population: All extension randomized patients that received at least 1 dose of extension study drug.||Ratio of relapses per year||95% Confidence Interval|Number
764269|NCT00662818|Secondary|Percentage of Participants With Absence of Nausea at 2 Hours Post-dose (Period 1, Migraine Attack 1)|The participant recorded whether nausea was present or absent at each of the predefined time points.|2 hours post-dose (Up to 6 weeks)|The FAS population included participants treated that migraine attack, and had both a baseline value and at least 1 post-dose efficacy measurement for nausea prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline nausea score or post-dose data through 2 hours.||Percentage of Participants||95% Confidence Interval|Number
764259|NCT00662649|Primary|Annualized Aggregate Relapse Rate (ARR) During Months 0-24 (Core Study) and Months 24-48 (Extension Study)|ARR is defined as the number of confirmed relapses in a year. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. The annualized ARR for each treatment group was the mean of the annualized ARRs for all patients in the group, calculated as the total number of confirmed relapses divided by the total number of days on study multiplied by 365.25.|Months 0-24 (core study) and Months 24-48 (extension study)|Extension intent-to-treat (ITT) population: All extension randomized patients that received at least 1 dose of extension study drug.||Relapses per year||95% Confidence Interval|Number
764260|NCT00662649|Secondary|Percent Change in Brain Volume From Month 0 to Month 24 (Core Study) and From Month 24 to Month 48 (Extension Study)|Calculations of brain volume change were performed using the structural image evaluation of normalized atrophy (SIENA), software included in the Functional Magnetic Resonance Imaging of the Brain (FMRIB) software library. SIENA is a fully automated method for estimating temporal brain volume change.|Months 0-24 (core study) and Months 24-48 (extension study)|Extension intent-to-treat (ITT) population: All extension randomized patients that received at least 1 dose of extension study drug.||Percent change||Standard Deviation|Mean
764261|NCT00662649|Secondary|Percentage of Patients Free of New or Newly Enlarged T2 Magnetic Resonance Imaging (MRI) Lesions During Months 0-24 (Core Study) and Months 24-48 (Extension Study)|The number of new or newly enlarged T2 lesions was assessed with T2-weighted MRI scans. A T2-weighted MRI scan utilizes particular values of the echo time (TE) and the repetition time (TR) parameters of image acquisition. Inflammation and tissue damage are seen as bright areas in T2 images and are often referred to as T2 lesions. T2 weighted MRI scans are a sensitive way to evaluate the brain for demyelinating diseases, such as multiple sclerosis.|Months 0-24 (core study) and Months 24-48 (extension study)|Extension intent-to-treat (ITT) population: All extension randomized patients that received at least 1 dose of extension study drug. The analysis included number of patients with evaluable T2 MRI scans.||Percentage of patients|||Number
764262|NCT00662649|Primary|Time to First Confirmed Relapse up to End of Study: Kaplan-Meier Estimate of Percentage of Patients Relapse-free|A relapse was confirmed when it was accompanied by an increase of at least half a step (0.5) on the Expanded Disability Status Scale (EDSS) or an increase of 1 point on two different Functional Systems (FS) of the EDSS or 2 points on one of the FS (excluding Bowel/Bladder or Cerebral FS). Kaplan-Meier estimates of the percentage of relapse-free patients at end of study and and 95% confidence intervals (CIs) were presented for the treatment groups.|Core baseline to end of study (maximum up to 60 months)|Core Intent to treat (ITT) population: All patients who were randomized in the Core study and received at least 1 dose of Core study drug.||Percentage of patients||95% Confidence Interval|Number
764263|NCT00662649|Secondary|Change in Mean Number of New or Newly Enlarged T2 Magnetic Resonance Imaging (MRI) Lesions During Months 0-24 (Core Study) and Months 24-48 (Extension Study)|The number of new or newly enlarged T2 lesions was assessed with T2-weighted MRI scans. A T2-weighted MRI scan utilizes particular values of the echo time (TE) and the repetition time (TR) parameters of image acquisition. Inflammation and tissue damage are seen as bright areas in T2 images and are often referred to as T2 lesions. T2 weighted MRI scans are a sensitive way to evaluate the brain for demyelinating diseases, such as multiple sclerosis.|Months 0-24 (core study) and Months 24-48 (extension study)|Extension intent-to-treat (ITT) population: All extension randomized patients that received at least 1 dose of extension study drug. The analysis included number of patients with evaluable T2 MRI scans.||Lesions||Standard Deviation|Mean
764264|NCT00662649|Primary|Annualized Aggregate Relapse Rate (ARR) During Months 0 to End of Study(Core [CFTY720D2301/NCT00289978] and Extension Study)|ARR is defined as the number of confirmed relapses in a year. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. The annualized ARR for each treatment group was the mean of the annualized ARRs for all patients in the group, calculated as the total number of confirmed relapses divided by the total number of days on study multiplied by 365.25.|Months 0 to end of study (maximum up to 60 months)|Core Intent to treat (ITT) population: All patients who were randomized in the Core study and received at least 1 dose of Core study drug.||Relapses per year||95% Confidence Interval|Number
764265|NCT00662675|Secondary|Percent of Patients Reporting Clinical Signs and Symptoms of Exocrine Pancreatic Insufficiency (EPI) During the Double-Blind Phase|Percent of patients reporting nausea, vomiting, bloating, diarrhea, oily/greasy stools, and abdominal pain signs and symptoms reported as Adverse events during the double-blind phase.|Entire 7 days double-blind phase|ITT||Percent of participants|||Number
764266|NCT00662675|Secondary|Change in Percent COA-Protein (Nitrogen)|The change in percent COA-protein from the stool collection period in double-blind phase to open-label phase|72-hours stool collection in the open-label phase to the end of 72-hours stool collection in the double-blind withdrawal phase.|ITT||percentage COA-protein||Standard Deviation|Mean
764267|NCT00662675|Primary|Change in the Coefficient of Fat Absorption (COA-fat Percent)|Change in the coefficient of fat absorption (percent COA-fat) from the 72-hour inpatient period in the open-label phase to the 72-hour period inpatient period in the double-blind (withdrawal) phase.|72-hours stool collection in the open-label phase to the end of 72-hours stool collection in the double-blind withdrawal phase.|Intent-to-Treat (ITT)||percentage COA-fat||Standard Deviation|Mean
764268|NCT00662818|Secondary|Percentage of Participants With Sustained Pain Freedom (SPF) at 2 to 24 Hours Post-dose|SPF from 2 to 24 hours post-dose is defined as PF at 2 hours, with no administration of either rescue medication or the optional second dose and with no occurrence thereafter of a mild/moderate/severe headache during the 2 to 24 hours after dosing with the study medication.|Up to 24 hours post-dose (Up to 14 weeks)|The FAS population was participants treated that migraine attack, and had both a baseline value and at least 1 post-dose efficacy measurement for pain severity prior to, or including, the 2-hr. time point. Participants were excluded from this analysis for not having a baseline pain score, post-dose data through 24 hrs, or a recurrence question.||Percentage of Participants||95% Confidence Interval|Number
768174|NCT00694473|Secondary|Accuracy of Navigator CGM as Compared to Reference Blood Glucose Values|Mean Absolute Relative Difference (MARD) of Navigator CGM compared with reference blood glucose values|72 hours|||percent absolute relative difference||Full Range|Mean
764270|NCT00662818|Secondary|Percentage of Participants With Absence of Photophobia at 2 Hours Post-dose (Period 1, Migraine Attack 1)|The participant recorded whether photophobia (sensitivity to light) was present or absent at each of the predefined time points.|2 Hours post-dose (Up to 6 weeks)|The FAS population included participants treated that migraine attack, and had both a baseline value and at least 1 post-dose efficacy measurement for photophobia prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline photophobia score or post-dose data through 2 hours.||Percentage of Participants||95% Confidence Interval|Number
764271|NCT00662818|Secondary|Percentage of Participants With Absence of Phonophobia at 2 Hours Post-dose (Period 1, Migraine Attack 1)|The participant recorded whether phonophobia (sensitivity to sound) was present or absent at each of the predefined time points.|2 hours post-dose (Up to 6 weeks)|The FAS population included participants treated that migraine attack, and had both a baseline value and at least 1 post-dose efficacy measurement for phonophobia prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline phonophobia score or post-dose data through 2 hours.||Percentage of participants||95% Confidence Interval|Number
764272|NCT00662818|Secondary|Number of Participants With a Confirmed Vascular Event Within 48 Hours Post-dose|Confirmed Vascular Event included cardiac events, cerebrovascular events, and peripheral vascular events.|Up to 48 hours after the dose of any study medication (Up to 14 weeks)|The APaT Population consisted of all participants who received at least 1 dose of study medication were included in the treatment group according to the medication actually received.||Participants|||Number
764273|NCT00662818|Primary|Number of Participants Discontinuing Study Drug Due to an AE Within 48 Hours Post-dose|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to 48 hours post-dose (Up to 14 weeks)|The APaT Population consisted of all participants who received at least 1 dose of study medication were included in the treatment group according to the medication actually received.||Participants|||Number
764274|NCT00662818|Primary|Number of Participants Who Experienced an Adverse Event (AE) Within 14 Days Post-dose|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Within 14 days of any dose of study medication (Up to 16 weeks)|All-Patients-as-Treated (APaT) population consisted of all participants who received at least 1 dose of study medication were included in the treatment group according to the medication actually received.||Participants|||Number
764275|NCT00662818|Secondary|Percentage of Participants With Pain Relief at 2 Hours Post-dose (Period 1, Migraine Attack 1)|Pain Relief (PR) at 2 hours post-dose (first migraine attack), with pain relief defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 1/0 at 2 hours post-dose. Headache severity was subjectively rated by the participant at predefined time points on a scale of Grade 0 to Grade 3: Grade 0 - No pain; Grade 1 - Mild pain; Grade 2 - Moderate Pain; and Grade 3 - Severe Pain.|2 hours post-dose (Up to 6 weeks)|The FAS Population included participants treated that migraine attack, and had both a baseline value and at least 1 post-dose efficacy measurement for pain severity prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline pain score or post-dose data through 2 hours.||Percentage of Participants||95% Confidence Interval|Number
764276|NCT00662818|Primary|Percentage of Participants With Pain Freedom at 2 Hours Post-dose (Period 1, Migraine Attack 1)|Pain Freedom (PF) at 2 hours post-dose (Period 1, Attack 1) defined as a decrease from a moderate or severe migraine headache (Grade 2 or 3) at baseline to no pain (Grade 0). Headache severity was subjectively rated by the participant at predefined time points on a scale of Grade 0 to Grade 3: Grade 0 - No pain; Grade 1 - Mild pain; Grade 2 - Moderate Pain; and Grade 3 - Severe Pain.|2 hours post-dose (Up to 6 weeks)|The full-analysis set (FAS) included participants treated for a migraine attack. Participants had both a baseline value and at least 1 post-dose efficacy measurement for pain severity prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline pain score or post-dose data through 2 hours.||Percentage of participants||95% Confidence Interval|Number
764277|NCT00662831|Other Pre-specified|Number of Clinically Relevant Minor Hemorrhages and Trivial Hemorrhages|Clinically relevant minor (non-major) bleeding was defined as any bleeding compromising hemodynamics, leading to hospitalization, subcutaneous haematoma more than 25 cm^2, intramuscular haematoma, epistaxis lasting for more than 5 minutes, spontaneous gingival bleeding, macroscopic hematuria and gastrointestinal hemorrhage (including at least 1 episode of melaena or hematemesis), rectal blood loss, hemoptysis, and any other bleeding with clinical consequences. Trivial bleeding was defined as all minor bleeding that did not meet the definition of clinically relevant minor bleeding.|Week 24 (EOT) or early termination|Safety analysis population included all participants who were known to have taken at least one dose of the study medication.||hemorrhages|||Number
764278|NCT00662831|Other Pre-specified|Number of Major and Minor Hemorrhages|Major hemorrhages: defined as fatal bleeding, clinically overt bleeding causing a fall in hemoglobin more than or equal to 20 gram (g)/litre (L) (2 g/ decilitre [dL]), clinically overt bleeding leading to transfusion of more than or equal to 2 units of whole blood or red cells, or symptomatic bleeding in areas of special concern (intracranial, retroperitoneal, intraocular, intraspinal, pericardial, intramuscular with compartmental syndrome, or intraarticular). Minor hemorrhages: defined as bleeding that did not meet the definition of major bleeding.|Week 24 (EOT) or early termination|Safety analysis population included all participants who were known to have taken at least one dose of the study medication.||hemorrhages|||Number
764279|NCT00662831|Other Pre-specified|Number of All Hemorrhages|Major hemorrhages: defined as fatal bleeding, clinically overt bleeding causing a fall in hemoglobin more than or equal to 20 gram (g)/litre (L) (2 g/ decilitre [dL]), clinically overt bleeding leading to transfusion of more than or equal to 2 units of whole blood or red cells, or symptomatic bleeding in areas of special concern (intracranial, retroperitoneal, intraocular, intraspinal, pericardial, intramuscular with compartmental syndrome, or intraarticular). Minor hemorrhages: defined as bleeding that did not meet the definition of major bleeding.|Week 24 (EOT) or early termination|Safety analysis population included all participants who were known to have taken at least one dose of the study medication.||hemorrhages|||Number
764280|NCT00662831|Secondary|Transcutaneous Local Tissue Oxygenation (pO2)|Transcutaneous pO2 was assessed at the dorsum of the foot in the first intermetatarsal space using an appropriately calibrated instrument. The skin oxygen partial pressure was determined by measuring the oxygen reduction current by means of a measuring cell.|Baseline and Week 24 (EOT or early termination)|ITT population included all participants who were randomized. Participants were analyzed at selected sites only, based on availability. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.||Units on a scale||Standard Deviation|Mean
764281|NCT00662831|Secondary|11-point Likert Pain Scale|The 11 point Likert pain scale which used a 0 (no pain) to 10 (worst possible pain) point rating system was used to assess participant’s pain score. No distinction was made between neuropathy and inflammatory (nociceptive) pain.|Baseline and Week 24 (EOT or early termination)|ITT population included all participants who were randomized. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.||Units on a scale||Standard Deviation|Mean
764282|NCT00662831|Secondary|36-Item Short-Form Health Survey (SF-36) Score|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline and Week 24 (EOT or early termination)|ITT population included all participants who were randomized. This was calculated only when more than half of the questions within dimension were answered. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.||Units on a scale||Standard Deviation|Mean
764283|NCT00662831|Secondary|Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS)|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline and Week 24 (EOT or early termination)|ITT population included all participants who were randomized. Participants were only considered when all items contributing to the score had been answered. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.||mm||Standard Deviation|Mean
764284|NCT00662831|Secondary|Euro Quality of Life-5 Dimensions (EQ-5D)- Utility Score|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. It assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Baseline and Week 24 (EOT or early termination)|ITT population included all participants who were randomized. Participants were only considered when all items contributing to the score had been answered. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.||Units on a scale||Standard Deviation|Mean
764285|NCT00662831|Secondary|Median Time to First Amputation||Week 24 (EOT) or early termination|The data was not analyzed as planned because the study enrollment was terminated before the planned number of randomized participants was obtained.||months||95% Confidence Interval|Median
764286|NCT00662831|Secondary|Time to Intact Skin Healing|Median time taken to achieve intact skin healing which was defined as 100 percent reduction in ulcer surface area with full epithelialisation.|Week 24 (EOT) or early termination|The data was not analyzed as planned because the study enrollment was terminated before the planned number of randomized participants was obtained.||months||95% Confidence Interval|Median
764287|NCT00662831|Secondary|Number of Participants With Major Cardiovascular Disease Events (MCVE)|Major cardiovascular events were defined as death due to vascular cause; non-fatal myocardial infarction (MI) excluding procedure related to MI; coronary revascularization procedures not related to MIs; hospitalization for unstable angina or non-fatal stroke.|Week 24 (EOT) or early termination|The data was not analyzed as planned because the study enrollment was terminated before the planned number of randomized participants was obtained.||participants|||Number
764288|NCT00662831|Secondary|Number of Participants Who Died||Week 24 (EOT) or early termination|ITT population included all participants who were randomized.||participants|||Number
764289|NCT00662831|Secondary|Number of Participants With Greater Than or Equal to 50 Percent Reduction in Ulcer Surface Area Excluding Intact Skin Healing|University of Texas (UT) system assesses ulcer depth, wound infection and clinical signs of lower-extremity ischemia. UT Wound Classification (1C/2C) was based on grade (0= healed site to 3= penetrating wound to bone or joint) and stage (A= clean wounds to D= ischaemic infected wounds) of wounds. Participants were evaluated at 4 stratums: Stratum 1: Toe pressure>30 mm of mercury (mmHg) and UT grade and stage 1C. Stratum 2: Toe pressure<=30 mmHg and UT grade and stage 1C. Stratum 3: Toe pressure>30 mmHg and UT grade and stage 2C. Stratum 4: Toe pressure<=30 mmHg and UT grade and stage 2C.|Week 24 (EOT) or early termination|ITT population included all participants who were randomized. LOCF method was used. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.||participants|||Number
764290|NCT00662831|Secondary|Number of Participants Who Underwent Major and Minor Amputation|A major amputation was defined as above the ankle and was reported as below-the-knee and above-the-knee amputations. A minor amputation was defined as below the ankle amputation.|Week 24 (EOT) or early termination|ITT population included all participants who were randomized.||participants|||Number
764291|NCT00662831|Secondary|Number of Participants Who Underwent Any Amputation|Any amputation included both major and minor amputations. A major amputation was defined as above the ankle and was reported as below-the-knee and above-the-knee amputations. A minor amputation was defined as below the ankle amputation.|Week 24 (EOT) or early termination|ITT population included all participants who were randomized.||participants|||Number
764624|NCT00665925|Secondary|Alanine Aminotransferase (ALT) >3-5x Upper Limit of Normal (ULN)|The number of participants with ALT (a test of liver function) values greater than 3 to 5 times the ULN|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.||Participants|||Number
764292|NCT00662831|Secondary|Number of Participants With Intact Skin Healing|Intact skin healing was defined as 100 percent reduction in ulcer surface area with full epithelialisation. UT system assesses ulcer depth, wound infection and clinical signs of lower-extremity ischemia. Participants were evaluated at 4 stratums: Stratum 1: Toe pressure>30 mm of mercury (mmHg) and UT grade and stage 1C. Stratum 2: Toe pressure<=30 mmHg and UT grade and stage 1C. Stratum 3: Toe pressure>30 mmHg and UT grade and stage 2C. Stratum 4: Toe pressure<=30 mmHg and UT grade and stage 2C.|Week 24 (EOT) or early termination|ITT population included all participants who were randomized. LOCF method was used. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.||participants|||Number
764293|NCT00662831|Primary|Number of Participants With Greater Than or Equal to 50 Percent Reduction in Ulcer Surface Area Including Intact Skin Healing|University of Texas (UT) system assesses ulcer depth, wound infection and clinical signs of lower-extremity ischemia. UT Wound Classification (1C/2C) was based on grade (0= healed site to 3= penetrating wound to bone or joint) and stage (A= clean wounds to D= ischaemic infected wounds) of wounds. Participants were evaluated at 4 stratums: Stratum 1: Toe pressure>30 mm of mercury (mmHg) and UT grade and stage 1C. Stratum 2: Toe pressure<=30 mmHg and UT grade and stage 1C. Stratum 3: Toe pressure>30 mmHg and UT grade and stage 2C. Stratum 4: Toe pressure<=30 mmHg and UT grade and stage 2C.|Week 24 [end of treatment (EOT)] or early termination|Intention to treat (ITT) population included all participants who were randomized. Last observation carried forward (LOCF) method was used. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.||participants|||Number
764294|NCT00662857|Primary|Relative Bioavailability of 30 U of TI (TI Inhalation Powder B) Versus 10 U of sc Insulin Lispro|Dose-normalized baseline-corrected area under the serum insulin vs. time curve (time 0 to 360 minutes post-dose)|0 to 360 minutes post-dose|"Rapid-acting insulin Analogue (RAA) Population
All subjects who had serum insulin concentration data for both TI Inhalation Powder B and insulin lispro and were deemed to be protocol compliant (no major protocol violations during the clinical trial)."||(micro U)*min/mL||Standard Error|Least Squares Mean
764295|NCT00662857|Primary|Bioequivalence of Two 15 U Cartridges (TI Inhalation Powder A) and One 30 U Cartridge (TI Inhalation Powder B) Based on Baseline Corrected Insulin Tmax||0 to 360 minutes post-dose|Per Protocol Population - All subjects who completed the crossover portion of the trial (through Visit 3), had serum insulin concentration data for both TI Inhalation Powder A and TI Inhalation Powder B and were deemed to be protocol compliant (no major protocol violations during the clinical trial).||min||Full Range|Median
764296|NCT00662857|Primary|Bioequivalence of Two 15 U Cartridges (TI Inhalation Powder A) and One 30 U Cartridge (TI Inhalation Powder B) Based on Baseline Corrected Insulin Cmax.|Maximum observed baseline-corrected serum insulin concentration|0 to 360 minutes post-dose|Per Protocol Population - All subjects who completed the crossover portion of the trial (through Visit 3), had serum insulin concentration data for both TI Inhalation Powder A and TI Inhalation Powder B and were deemed to be protocol compliant (no major protocol violations during the clinical trial).||(micro U)/mL||Standard Error|Least Squares Mean
764297|NCT00662857|Primary|Bioequivalence of Two 15 U Cartridges (TI Inhalation Powder A) and One 30 U Cartridge (TI Inhalation Powder B) Based on Baseline Corrected Insulin AUC0-360|Dose-normalized baseline-corrected area under the serum insulin vs. time curve|0 to 360 minutes post-dose|Per Protocol Population - All subjects who completed the crossover portion of the trial (through Visit 3), had serum insulin concentration data for both TI Inhalation Powder A and TI Inhalation Powder B and were deemed to be protocol compliant (no major protocol violations during the clinical trial).||(micro U)*min/mL||Standard Error|Least Squares Mean
764298|NCT00662909|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:
I am not anxious or depressed; I am moderately anxious or depressed; I am extremely anxious or depressed. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit."|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.||participants|||Number
764299|NCT00662909|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:
I have no pain or discomfort; I have moderate pain or discomfort; I have extreme pain or discomfort. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit."|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.||participants|||Number
764300|NCT00662909|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score|The EQ-5D is a standardized, nondisease-specific instrument for describing health status. Participants were asked which statement best describes their health state with regard to usual activities (work, study or leisure): I have no problems performing my usual activities; I have some problems performing my usual activities; I am unable to perform my usual activities. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available at that Visit.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.||participants|||Number
764382|NCT00663169|Secondary|Change in C-reactive Protein (CRP) From Baseline at Month 4|Blood was collected at Baseline and Month 4 for CRP to identify the presence of inflammation, to determine its severity, and to monitor response to treatment. A negative change from baseline indicates improvement.|Baseline, Month 4|Pharmacodynamic set included all randomized patients with evaluable (or complete) pharmacodynamic parameter data.||mg/L||Standard Deviation|Mean
764301|NCT00662909|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:
I have no problems with self-care; I have some problems washing or dressing myself; I am unable to wash or dress myself. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit."|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.||participants|||Number
764302|NCT00662909|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:
I have no problems in walking about; I have some problems in walking about; I am confined to bed.
In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit."|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.||participants|||Number
764303|NCT00662909|Secondary|Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) at Week 12 and Final Visit|The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Improvement was defined as at least a 1 point improvement from Baseline to post-baseline and a major improvement was defined as at least a 2 point improvement from Baseline to post-baseline in PPBC score.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants at each time point (N) only includes those with baseline and post-baseline values. LOCF was used for the Final Visit analysis.||Percentage of participants|||Number
764304|NCT00662909|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Number of Non-study Related Visits to Physician|The number of times the patient visited a physician's office during the 4 weeks prior to each study visit (excluding study visits) because of the patient's bladder condition.|Baseline and Weeks 4, 8 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants at each time point (N) includes only patients with both baseline and post-baseline values. LOCF was used for the Final Visit analysis.||Physician visits||Standard Deviation|Mean
764305|NCT00662909|Secondary|Change From Baseline to Week 12 and Final Visit in Treatment Satisfaction on Visual Analog Scale (TS-VAS)|The TS-VAS is a visual analog scale (VAS) that asks patients to rate their satisfaction with treatment by placing a vertical mark on a 10 cm line where the endpoints are labeled ‘No, not at all’ on the left (=0) to ‘Yes, completely satisfied’ on the right (=10). LS means are from an ANCOVA model with treatment group, gender, and geographical regions as fixed factors and baseline as a covariate. A positive change from baseline indicates improvement.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants included at each time point (N) only includes those with baseline and post-baseline values. LOCF was used for the Final Visit analysis.||Scores on a scale||Standard Error|Least Squares Mean
764306|NCT00662909|Secondary|Change From Baseline to Week 12 and Final Visit in Patient Perception of Bladder Condition (PPBC)|The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems’; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. LS means are from an ANCOVA model with treatment group, gender, and geographical regions as fixed factors and baseline as a covariate. A negative change from Baseline score indicates improvement.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants included at each time point (N) only includes those with baseline and post-baseline values. LOCF was used for the Final Visit analysis.||Scores on a scale||Standard Error|Least Squares Mean
764307|NCT00662909|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)|The EQ-5D is an international, standardized, generic instrument for describing and evaluating health status. Health status is assessed by patients evaluating their health on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (=0) and 'Best imaginable health state' (=100). On the EQ-5D VAS, a positive change from baseline indicates improvement.|Baseline and Weeks 4, 8 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of participants at each time point (N) includes only patients with both baseline and post-baseline values. LOCF was used for the Final Visit analysis.||Scores on a scale||Standard Deviation|Mean
764315|NCT00662909|Secondary|Percentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit|The percentage of participants with no incontinence episodes for the 3 days prior to each clinic visit derived from the micturition diary recorded by the patient.|Weeks 4, 8 and 12|The full analysis set-incontinence included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary & who had at least 1 incontinence episode at baseline. LOCF was used for the Final Visit analysis. N is the number of patients included at each time point.||Percentage of participants|||Number
764308|NCT00662909|Secondary|Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with daily activities over the last 7 days. Percent activity impairment is derived from the patient’s assessment of the degree to which OAB affected their regular daily activities. A higher percentage indicates greater impairment. A negative change from baseline indicates improvement.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants at each time point (N) included patients with both baseline and post-baseline values. LOCF was used for the Final Visit analysis.||percent activity impairment||Standard Deviation|Mean
764309|NCT00662909|Secondary|Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent overall work impairment takes into account both hours missed due to OAB symptoms and the patient’s assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values who were employed. LOCF was used for the Final Visit analysis.||percent overall work impairment||Standard Deviation|Mean
764310|NCT00662909|Secondary|Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent impairment while working was derived from the patient’s assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values who were employed. LOCF was used for the Final Visit analysis.||percent impairment while working||Standard Deviation|Mean
764311|NCT00662909|Secondary|Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent of work time missed is derived from the number of hours of work missed due to OAB symptoms as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed. A negative change from baseline indicates improvement.|Baseline and Week12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values who were employed. LOCF was used for the Final Visit analysis.||percent work time missed||Standard Deviation|Mean
764312|NCT00662909|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score|"Health-related quality of life was assessed by the HRQL subscales (coping, concern, sleep and social interaction) of the overactive bladder questionnaire (OABq). The HRQL total score was calculated by adding the 4 HRQL subscale scores, and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from Baseline in HRQL score indicates improvements.
LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate."|Baseline and Weeks 4, 8 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for the Final Visit analysis. The number of participants included in the calculation for each time point is noted as “N”.||Scores on a scale||Standard Error|Least Squares Mean
764313|NCT00662909|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Symptom Bother Score|"Overactive bladder symptoms were assessed using the symptom bother scale of the overactive bladder questionnaire. The symptom bother scale consists of 8 questions answered by the participant on a scale from 1-6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from Baseline in symptom bother score indicates improvements.
LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate."|Baseline and Weeks 4, 8 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for the Final Visit analysis. The number of participants included in the calculation for each time point is noted as “N”.||Scores on a scale||Standard Error|Least Squares Mean
764314|NCT00662909|Secondary|Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit|The percentage of participants with at least 50% decrease from baseline in mean number of incontinence episodes per 24 hours during the 3 days prior to each clinic visit derived from the patient micturition diary.|Baseline and Weeks 4, 8 and 12|The full analysis set-incontinence included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary & who had at least 1 incontinence episode at baseline. LOCF was used for the Final Visit analysis. N is the number of patients included at each time point.||Percentage of participants|||Number
764332|NCT00663026|Secondary|Serum Decay Half-Life (t1/2)|Serum decay half-life is the time measured for the serum concentration to decrease by one half.|Predose, 4 hrs postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12|t1/2 not calculated due to inadequate characterization of the terminal elimination phase.|||||
764316|NCT00662909|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Pads Used Per 24 Hours|"The average number of times a patient records a new pad used per day during the 3-day micturition diary period.
LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate."|Baseline and Weeks 4, 8 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary and who had at least one use of a pad at baseline. LOCF was used for the Final Visit analysis. N is the number of participants included at each time point.||pads||Standard Error|Least Squares Mean
764317|NCT00662909|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours|"Nocturia is defined as waking at night one or more times to void. The average number of times a patient urinated (excluding incontinence only episodes) during sleeping time per day was derived from the 3-day patient micturition diary.
LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate."|Baseline and Weeks 4, 8 and 12|"The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 post baseline micturition measurement in the visit diary and who had at least one nocturia episode at baseline. LOCF was used for the Final Visit analysis.
N is the number of participants included at each time point."||Nocturia episodes||Standard Error|Least Squares Mean
764318|NCT00662909|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Level of Urgency|Average of patients’ ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in a 3-day micturition diary according to the following 5-point categorical scale (Patient Perception of Intensity of Urgency Scale): 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 4, 8 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 post baseline micturition measurement in the visit diary. LOCF was used for the Final Visit analysis. The number of participants included in the calculation for each time point is noted as “N”.||Scores on a scale||Standard Error|Least Squares Mean
764319|NCT00662909|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Episodes (Grades 3 or 4) Per 24 Hours|The average number of urgency episodes (the sudden, compelling desire to pass urine, which is difficult to defer), derived from urgency episodes classified by the patient in a 3-day micturition diary as grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 4, 8 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 post baseline micturition measurement in the visit diary and at least 1 episode of urgency grade 3 or 4 at baseline. LOCF was used for the Final Visit analysis. N is the number of patients included at each time point.||Urgency episodes||Standard Error|Least Squares Mean
764320|NCT00662909|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours|The involuntary leakage of urine accompanied by or immediately proceeded by urgency, derived from the number of incontinence episodes classified by the patient in a 3-day micturition diary as 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 4, 8 and 12|The full analysis set-incontinence included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 post baseline micturition measurement in the visit diary & at least 1 urgency incontinence episode at baseline. LOCF was used for the Final Visit analysis. N = the number of patients included at each time point.||Urgency incontinence episodes||Standard Error|Least Squares Mean
764321|NCT00662909|Secondary|Change From Baseline to Week 4, Week 8 and Week 12 in Mean Volume Voided Per Micturition|The average volume voided per micturition was calculated from the volume of each micturition measured by the patient and recorded in a micturition diary for 3 days before the Baseline and Week 4, 8 and 12 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 4, 8 and 12|The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. LOCF was not utilized in this analysis. The number of participants included in the calculation for each time point is noted as “N”.||mL||Standard Error|Least Squares Mean
764322|NCT00662909|Secondary|Change From Baseline to Week 8 and Week 12 in Mean Number of Micturitions Per 24 Hours|The average number of micturitions (urinations) per 24 hours was calculated from the number of micturitions recorded by the patient in a micturition diary for 3-days before the Baseline, Week 8 and 12 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 8 and 12|The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. LOCF was not used in this analysis. The number of patients included in the calculation for each time point is noted as “N”.||Micturitions||Standard Error|Least Squares Mean
764333|NCT00663026|Secondary|Average Serum Concentration at Steady State (Cavg,ss)|Average plasma concentration at steady state (Cavg,ss) = AUCtau divided by dosing interval (1 week). AUCtau is the area under the plasma concentration time curve (AUC) at steady state from time zero (pre-dose) to end of dosing interval (tau), here dosing interval is 1 week.|Predose, 4 hrs postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12|PK analysis set included all participants who provided data for the estimation of at least 1 of the relevant PK parameters (Cmax, tmax, AUC, t1/2, CL/F and Vz/F). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||ng/mL||Standard Deviation|Mean
764323|NCT00662909|Secondary|Change From Baseline to Week 8 and Week 12 in Mean Number of Incontinence Episodes Per 24 Hours|The average number of incontinence episodes (any involuntary leakage of urine) per 24 hours was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline, Week 8 and Week 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 8 and 12|The full analysis set-incontinence included all randomized patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 post baseline micturition measurement in the visit diary and at least 1 incontinence episode at baseline. The number of patients included at each time point is noted as “N”. LOCF was not utilized.||Incontinence episodes||Standard Error|Least Squares Mean
764324|NCT00662909|Secondary|Change From Baseline to Week 4 in Mean Number of Micturitions Per 24 Hours|The average number of micturitions (urinations) per 24 hours was calculated from the number of micturitions recorded by the patient in a micturition diary for 3-days before the Baseline and Week 4 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 4|The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. Last observation carried forward was not used in this analysis.||Micturitions||Standard Error|Least Squares Mean
764325|NCT00662909|Secondary|Change From Baseline to Week 4 in Mean Number of Incontinence Episodes Per 24 Hours|The average number of incontinence episodes (any involuntary leakage of urine) per 24 hours was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline and Week 4 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 4|The full analysis set-incontinence included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary and who had at least 1 incontinence episode at baseline. Last observation carried forward was not used in this analysis.||Incontinence episodes||Standard Error|Least Squares Mean
764326|NCT00662909|Secondary|Change From Baseline to Final Visit in Mean Volume Voided Per Micturition|The average volume voided per micturition was calculated from the volume of each micturition measured by the patient and recorded in a micturition diary for 3 days before the Baseline and Week 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 12|The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. Last observation carried forward was used in this analysis.||mL||Standard Error|Least Squares Mean
764327|NCT00662909|Primary|Change From Baseline to End of Treatment (Final Visit) in Mean Number of Micturitions Per 24 Hours|The average number of micturitions (urinations) per 24 hours was derived from the number of times a patient urinates (excluding incontinence only episodes) per day recorded by the patient in a micturition diary for 3-days before the Baseline and Week 12 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 12|The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. Last observation carried forward was used in this analysis.||Micturitions||Standard Error|Least Squares Mean
764328|NCT00662909|Primary|Change From Baseline to End of Treatment (Final Visit) in Mean Number of Incontinence Episodes Per 24 Hours|The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline and Week 12 clinic visits. Least Squares (LS) Means were generated from an analysis of covariance (ANCOVA) model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 12 (Final Visit)|The full analysis set-incontinence included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary and who had at least 1 incontinence episode at baseline. Last observation carried forward (LOCF) was used in this analysis.||Incontinence episodes||Standard Error|Least Squares Mean
764329|NCT00663026|Secondary|Apparent Systemic Clearance (CL/F)|Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after subcutaneous dose (apparent systemic clearance) is influenced by the fraction (F) of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. Steady-state apparent systemic clearance (CL/F) was calculated as dose/AUC tau.|Predose, 4 hrs postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12|PK analysis set included all participants who provided data for the estimation of at least 1 of the relevant PK parameters (Cmax, tmax, AUC, t1/2, CL/F and Vz/F). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||milliliter/hour/kilogram (mL/hr/kg)||Standard Deviation|Mean
764330|NCT00663026|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)|AUCtau is the area under the serum concentration time curve (AUC) at steady state from time zero (pre-dose) to end of dosing interval (tau), here dosing interval is 1 week.|Predose, 4 hrs postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12|PK analysis set included all participants who provided data for the estimation of at least 1 of the relevant PK parameters (Cmax, tmax, AUC, t1/2, CL/F and Vz/F). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||ng*hr/mL||Standard Deviation|Mean
764331|NCT00663026|Secondary|Time to Reach Maximum Observed Serum Concentration (Tmax)||Predose, 4 hrs postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12|PK analysis set included all participants who provided data for the estimation of at least 1 of the relevant PK parameters (Cmax, tmax, AUC, t1/2, CL/F and Vz/F).||hours||Full Range|Median
768200|NCT00695396|Secondary|Transfusion Dependent|Participants who were transfusion-dependent were those who received 4 or more RBC units during a consecutive 8-week period.|Approximately 48 weeks|The intent-to-treat (ITT) population.||participants|||Number
764334|NCT00663026|Secondary|Maximum Observed Serum Concentration (Cmax)||Predose, 4 hours [hrs] postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12|Pharmacokinetic (PK) analysis set included all participants who provided data for the estimation of at least 1 of the relevant PK parameters (Cmax, time to maximum concentration [tmax], area under the curve [AUC], terminal elimination half-life [t1/2], apparent systemic clearance [CL/F], and apparent volume of distribution [Vz/F]).||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
764335|NCT00663026|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after Week 25 dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to 30 days after Week 25 dose|Safety population included all randomized participants who received at least 1 dose of study medication.||participants|||Number
764336|NCT00663052|Other Pre-specified|Mean Number of Doctor Visits|As a part of pharmacoeconomic questionnaire, the mean number of doctor visits were summarized.|Week 12 and Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. OC analyses were performed including only those participants who were evaluated at the specified visits.||Visits||Standard Deviation|Mean
764337|NCT00663052|Other Pre-specified|Percentage of Participants With Doctor Visits|As a part of pharmacoeconomic questionnaire, the percentage of participants who had doctor visits were presented as Yes or No.|Week 12 and Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. OC analyses were performed including only those participants who were evaluated at the specified visits.||Percentage of participants|||Number
764338|NCT00663052|Other Pre-specified|Mean Number of Emergency Room Days|As a part of pharmacoeconomic questionnaire, mean number of emergency room days were summarized.|Week 12 and Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. OC analyses were performed including only those participants who were evaluated at the specified visits.||Days||Standard Deviation|Mean
764339|NCT00663052|Other Pre-specified|Percentage of Participants With Emergency Room Visits|As a part of pharmacoeconomic questionnaire, the visits to emergency room were evaluated and presented as Yes or No.|Week 12 and Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. OC analyses were performed including only those participants who were evaluated at the specified visits.||Percentage of participants|||Number
764340|NCT00663052|Other Pre-specified|Mean Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Questionnaire Total Scores|FACIT Fatigue questionnaire: Participant rated 13 items questionnaire to assess fatigue. For each question, participant rates his / her condition for the past week on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). Higher scores always represent less fatigue. The total FACIT-Fatigue score ranges from 0 to 52 and is the sum of non-missing item scores; divided by the number of non-missing items, then multiplied by 13. If more than 6 items were missing, the total score was missing.|Week 12 and Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.||Units on scale||Standard Deviation|Mean
764341|NCT00663052|Other Pre-specified|Mean Medical Outcomes Study (MOS) Sleep Scale Scores at Week 24|MOS: participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.|Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.||Units on scale||Standard Deviation|Mean
764342|NCT00663052|Other Pre-specified|Mean Medical Outcomes Study (MOS) Sleep Scale Scores at Week 12|MOS scale has 12 questions to assess sleep quality & quantity: 1)time to fall asleep, 2)hours of sleep/night in past 4 weeks,3)sleep not peaceful, 4)got enough sleep to feel rested in morning,5)awaken short of breath/headache 6)feel drowsy in day,7)trouble going to sleep, 8)wake up during sleep; trouble going back to sleep,9)trouble staying awake in day, 10)Snoring,11)take naps in day,12)get amount of sleep needed. Sleep problem index(SPI) I:mean of 4,5,7,8,9,12; SPI II:mean of 1,3,4,5,6,7,8,9,12. All reported responses are on scale:0-100, higher scores indicate greater intensity of attribute.|Week 12|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.||Units on scale||Standard Deviation|Mean
764343|NCT00663052|Other Pre-specified|Work Productivity and Activity Impairment: Psoriasis (WPAI:PSO) at Week 24|WPAI:PSO - participant rated questionnaire to assess effect of psoriasis on ability to work and perform regular activities in 4 areas: percent activity impairment (0 [no effect on daily activities] to 100 [psoriasis completely prevented from doing daily activities]), percent impairment while working (0 [no effect] to 100 [completely prevented from working]); percent work time missed due to psoriasis, and percent overall work impairment (0 [no effect] to 100 [completely prevented from working]).|Week 24|mITT population: all randomized participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had missing values at any time point, LOCF method of imputation used. 'n' signifies participants evaluated for this measure at each timepoint, for each group respectively.||Percentage of indicated parameter||Standard Deviation|Mean
764383|NCT00663169|Secondary|Number of Participants With Discontinuation of Treatment Due to Adverse Events, Deaths or Serious Adverse Events During the Study|Additional safety information can be found in the Adverse Event section.|4 months|||Participants|||Number
764344|NCT00663052|Other Pre-specified|Work Productivity and Activity Impairment: Psoriasis (WPAI:PSO) at Week 12|WPAI:PSO - participant rated questionnaire to assess effect of psoriasis on ability to work and perform regular activities in 4 areas: percent activity impairment (0 [no effect on daily activities] to 100 [psoriasis completely prevented from doing daily activities]), percent impairment while working (0 [no effect] to 100 [completely prevented from working]); percent work time missed due to psoriasis, and percent overall work impairment (0 [no effect] to 100 [completely prevented from working]).|Week 12|mITT population: all randomized participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had missing values at any time point, LOCF method of imputation used. 'n' signifies participants evaluated for this measure at each timepoint, for each group respectively.||Percentage of indicated parameter||Standard Deviation|Mean
764345|NCT00663052|Other Pre-specified|Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) - Depression Score|HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.|Baseline, Week 12 and Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.||Units on scale||Standard Error|Mean
764346|NCT00663052|Other Pre-specified|Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) - Anxiety Score|HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.|Baseline, Week 12 and Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.||Units on scale||Standard Error|Mean
764347|NCT00663052|Other Pre-specified|Change From Baseline in the Euro Quality of Life 5 Dimension (EQ-5D) Utility Index|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (example confined to bed). Scoring formula developed by EuroQol Group assigns utility value for each domain in the profile. Score is transformed and results in total score range -0.594 to 1.000; higher score indicates better health state."|Baseline, Week 12 and Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.||Units on scale||Standard Error|Mean
764348|NCT00663052|Other Pre-specified|Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score to Week 24|DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst).|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.||Units on scale||Standard Error|Mean
764349|NCT00663052|Other Pre-specified|Percentage of Participants Who Were Considered Satisfied With Primary Psoriasis Treatment According to Psoriasis Subject Satisfaction Questionnaire (PSSQ)|PSSQ: participant’s assessment that includes 18 items, 16 items (1-16) scored using Likert score with scores from 0 (very dissatisfied) to 4 (very satisfied) and 5 (never had this problem). Only those participants who do not have score of 5 at baseline included in the item 1-16 analyses. Two items (17, 18) with Yes/No answers are summarized here.|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.||Percentage of participants|||Number
764350|NCT00663052|Other Pre-specified|Percentage of Participants Who Were Considered Satisfied With Health State According to Psoriasis Subject Satisfaction Questionnaire (PSSQ)|PSSQ: participant’s assessment that includes 18 items, 16 items (1-16) scored using Likert score with scores from 0 (very dissatisfied) to 4 (very satisfied) and 5 (never had this problem). Only those participants who do not have score of 5 at baseline included in the item 1-16 analyses. Two items (17, 18) with Yes/No answers are summarized here.|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.||Percentage of participants||95% Confidence Interval|Number
764351|NCT00663052|Secondary|Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 24|PSSQ: participant’s assessment that includes 18 items, 16 items (1-16) scored using Likert score with scores from 0 (very dissatisfied) to 4 (very satisfied) and 5 (never had this problem). Only those participants who do not have score of 5 at baseline included in the item 1-16 analyses. Two items (17, 18) are with Yes/No answers. The scores of items 1-16 for change from baseline are summarized here.|Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.||Units on scale||Standard Deviation|Mean
764379|NCT00663169|Secondary|Change From Baseline in Pain Using a Visual Analog Scale at Month 4|Patients rated their pain on a 100 millimeter (mm) visual analog scale, ranging from no pain (0) to unbearable pain (100). A negative change from baseline indicates improvement.|Baseline, Month 4|Pharmacodynamic set included all randomized subjects with evaluable (or complete) pharmacodynamic parameter data.||Score on a scale||Standard Deviation|Mean
764352|NCT00663052|Secondary|Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 12|PSSQ: participant’s assessment that includes 18 items, 16 items (1-16) scored using Likert score with scores from 0 (very dissatisfied) to 4 (very satisfied) and 5 ( never had this problem). Only those participants who do not have score of 5 at baseline included in the item 1-16 analyses. Two items (17, 18) are with Yes/No answers. The scores of items 1-16 for change from baseline are summarized here.|Week 12|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.||Units on scale||Standard Deviation|Mean
764353|NCT00663052|Other Pre-specified|Percentage of Participants Evaluated by Physicians Using Psoriasis Physician Satisfaction Questionnaire (PPSQ): Consider Primary Psoriasis Therapy Satisfactory From Baseline at Each Visit Through Week 24|Physician Psoriasis Satisfaction Questionnaire (PPSQ) includes two global satisfaction questions to which physicians respond either ‘satisfactory’ or ‘not satisfactory.’ These are: 1) whether the participant’s current condition is satisfactory, considering psoriasis symptoms, skin appearance and all other problems that psoriasis causes; 2) whether the participant’s current primary psoriasis therapy is satisfactory, considering psoriasis symptoms, skin appearance, therapy side effects and therapy ease/difficulty of use. Each of these questions was summarized for change from baseline.|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.||Percentage of participants||95% Confidence Interval|Number
764354|NCT00663052|Other Pre-specified|Percentage of Participants Evaluated Using Psoriasis Physician Satisfaction Questionnaire (PPSQ): Consider Patient's Condition Satisfactory From Baseline at Each Visit Through Week 24|Physician Psoriasis Satisfaction Questionnaire (PPSQ) included two global satisfaction questions to which physicians respond either ‘satisfactory’ or ‘not satisfactory.’ These are: 1) whether the participant’s current condition is satisfactory, considering psoriasis symptoms, skin appearance and all other problems that psoriasis causes; 2) whether the participant’s current primary psoriasis therapy is satisfactory, considering psoriasis symptoms, skin appearance, therapy side effects and therapy ease/difficulty of use. Each of these questions was summarized for change from baseline.|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.||Percentage of participants||95% Confidence Interval|Number
764355|NCT00663052|Other Pre-specified|Change From Baseline in Psoriatic Arthritis Screening and Evaluation (PASE) Total Score at Week 12|PASE a participant-administered questionnaire and a simple scoring system to assist physicians in screening participants with psoriasis for evidence of psoriatic arthritis with two sub-scales: system sub-scale and function sub-scale. Total of 15 questions in both sub-scales (7 questions in system and 8 in function sub-scale) to score from 1 to 5; where 1 = strongly disagree and 5 = strongly agree. The total of system and function scores provides the total PASE score ranging from 15 to 75 where higher scores indicate greater severity.|Baseline, Week 12|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.||Units on scale||Standard Error|Mean
764356|NCT00663052|Secondary|Percentage of Participants Not Using Topical Preparations at Each Visit From Week 12 Through Week 24|Moderate topical steroids to very potent topical steroids, topical vitamin D analogs, topical steroids in combination with vitamin D analogs, and anthralin compounds were prohibited for 14 days before the baseline visit until week 12.|From Week 12 to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.||Percentage of participants|||Number
764357|NCT00663052|Secondary|Change From Baseline in the Photographed Image of Lesions in Selected Participants|Compare the before and after photographs with the clinical assessments (Psoriasis Area and Severity Index, Physician's Global Assessment) taken at the same time for illustration purposes. Measured as yes or no for change.|Baseline to Week 24|The data was not collected as planned.||Units on scale|||Number
764358|NCT00663052|Secondary|Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Each Visit Through Week 24||Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.||Percentage of BSA||Standard Deviation|Mean
764359|NCT00663052|Other Pre-specified|Change From Baseline in Subject Global Assessment (SGA) of Psoriasis at Each Visit Through Week 24|SGA of Psoriasis: score based on participant's assessment of psoriasis disease activity at a scale of 0 to 5; where 0 = good and 5 = severe.|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.||Units on scale||Standard Error|Mean
764360|NCT00663052|Other Pre-specified|Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Each Visit Through Week 24|SGA of Joint Pain: score based on participant's assessment of joint pain at a scale of 0 to 5; where 0 = no pain and 5 = severe pain.|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.||Units on scale||Standard Error|Mean
764361|NCT00663052|Other Pre-specified|Change From Baseline in Subject Global Assessment (SGA) of Itching at Each Visit Through Week 24|SGA of Psoriasis: score based on participant's assessment of itching at a scale of 0 to 5; where 0 = no itching and 5 = severe itching.|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.||Units on scale||Standard Error|Mean
764384|NCT00663169|Secondary|Time to Walk Independently (if Applicable) During Treatment Period||4 months|Since the study recruited only 6 subjects this analysis was not done.|||||
764362|NCT00663052|Secondary|Change From Baseline in Physician Global Assessment (PGA) of Psoriasis at Each Visit Through Week 24|PGA of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease.|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.||Units on scale||Standard Error|Mean
764363|NCT00663052|Secondary|Time to First Physician Global Assessment (PGA) of Psoriasis of Clear/Almost Clear (0, 1), or Clear/Almost Clear/Mild (0, 1, 2) Over 24 Weeks|Time taken to achieve PGA was calculated using Kaplan-Meier estimate and presented as median. Assessment of clear or almost clear or Mild = PGA score of 0 (no evidence) or 1 (minimal/faint) or 2 (mild plaque elevation, mild fine scales predominates or light red coloration).|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. OC analyses were performed including only those participants who were evaluated at the specified visits.||Days||95% Confidence Interval|Median
764364|NCT00663052|Secondary|Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses of Clear/Almost Clear/Mild (0, 1, 2) at Each Visit Through Week 24|PGA of Psoriasis: score based on dermatologist's assessment of head, scalp, and neck psoriasis (averaged over all lesions). The PGA of Psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). PGA score of 0 = Status of Clear; 1 = Almost Clear and 2 = Mild.|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.||Percentage of participants||95% Confidence Interval|Number
764365|NCT00663052|Secondary|Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses Clear/Almost Clear (0, 1) at Each Visit Through Week 24|PGA of Psoriasis: score based on dermatologist's assessment of head, scalp, and neck psoriasis (averaged over all lesions). The PGA of Psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). PGA score of 0 = Status of Clear; 1 = Almost Clear.|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.||Percentage of participants||95% Confidence Interval|Number
764366|NCT00663052|Secondary|Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses of Clear (0) at Each Visit Through Week 24|PGA of Psoriasis: score based on dermatologist's assessment of head, scalp, and neck psoriasis (averaged over all lesions). The PGA of Psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). PGA score of 0 = Status of Clear.|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.||Percentage of participants||95% Confidence Interval|Number
764367|NCT00663052|Secondary|Time to Achieve Psoriasis Area and Severity Index (PASI) 50, PASI 75 and PASI 100 Over 24 Weeks|Time taken to achieve first PASI was calculated using Kaplan-Meier estimate and presented as median. PASI 50=50% improvement from baseline in PASI; PASI 75=75% improvement from baseline in PASI; PASI 90=90% improvement from baseline in PASI; PASI 100=100% improvement from baseline in PASI. PASI score percent improvement =100*(baseline score - visit score)/baseline score.|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. Observed cases (OC) analyses were performed including only those participants who were evaluated at the specified visits.||Days||95% Confidence Interval|Median
764368|NCT00663052|Secondary|Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24|PASI: Combined assessment of lesion severity and area affected into single score; range: 0(no disease) to 72(maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area scored by itself and scores were combined for final PASI. For each section, percent area of skin involved estimated: 0 (0%) to 6 (90 – 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.||Units on scale||Standard Error|Mean
764369|NCT00663052|Secondary|Percentage of Participants Achieving a 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24|PASI: Combined assessment of lesion severity and area affected into single score; range: 0(no disease) to 72(maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area was scored by itself and scores were combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90 – 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.||Percentage of participants||95% Confidence Interval|Number
764380|NCT00663169|Secondary|ACZ885 (Canakinumab) Pharmacokinetics (PK) Serum Concentration During the Treatment Period|Blood was collected for ACZ885 (canakinumab) levels at baseline and Days 0.25, 1, 3, 6, 20, 34, 55 and 119. Serum was analyzed by means of a competitive Enzyme linked immunosorbant assay (ELISA).|Baseline, Days 0.25, 1, 3, 6, 20, 34, 55 and 119|Pharmacodynamic set included all randomized subjects with evaluable (or complete) pharmacodynamic parameter data.||μg/mL||Standard Deviation|Mean
764385|NCT00663169|Secondary|Time to Recurrence of the Symptoms of Acute Gout (if Applicable) During Treatment Period|Time to recurrence is defined as from the point of improvement (good to excellent on Likert scale) to recurrence.|4 months|Since the study recruited only 6 subjects this analysis was not done.|||||
764370|NCT00663052|Secondary|Percentage of Participants Achieving a 90% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24|PASI: Combined assessment of lesion severity and area affected into single score; range: 0(no disease) to 72(maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area was scored by itself and scores were combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90 – 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).|Baseline to week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.||Percentage of participants|||Number
764371|NCT00663052|Secondary|Percentage of Participants Achieving a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24|PASI: Combined assessment of lesion severity and area affected into single score; range: 0(no disease) to 72(maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area was scored by itself and scores were combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90 – 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.||Percentage of participants|||Number
764372|NCT00663052|Secondary|Percentage of Participants Achieving a 50% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24|PASI: Combined assessment of lesion severity and area affected into single score; range: 0(no disease) to 72(maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area was scored by itself and scores were combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90 – 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.||Percentage of participants|||Number
764373|NCT00663052|Primary|Percentage of Participants Achieving a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 24|PASI: Combined assessment of lesion severity and area affected into single score; range: 0(no disease) to 72(maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area was scored by itself and scores were combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90 – 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).|Week 24|Modified intent-to-treat (mITT) population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the last observation carried forward (LOCF) method of imputation was used.||Percentage of participants|||Number
764374|NCT00663117|Secondary|Histology Inflammatory Score by Colon Biopsies|Histology scores to assess microscopic inflammation and structural architecture were determined at baseline and after 12 weeks of either naltrexone therapy or placebo by mucosal biopsy samples obtained during colonoscopies.The pathology specimens were reviewed and scored by a Pathologist blinded to the treatment. The mean scores at baseline were the same between both groups.Differences between naltrexone and placebo treated subjects was assessed.The range in scores could be 0-25, with 0 representing no inflammation and 25 being maximum or severe inflammation..|12 weeks|Tissue was removed by biopsy in those undergoing colonoscopy||units on a scale||Standard Error|Mean
764375|NCT00663117|Secondary|Percentage of Patients With a 5 Point Drop in CDEIS Score by Endoscopy|A secondary outcome was the appearance of the colonic mucosa on endoscopy using the Crohn’s Disease Endoscopic Index of Severity (CDEIS) score described by Mary et al. Gut 1989;30:983–989.This score ranges from 0-44 based upon the extent and severity of inflammation and ulcers seen during endoscopy of the colon. A response is a drop of > 5 points from baseline. Endoscopic remission is a score of < 6 and Complete endoscopic remission is a score of > 3.|12 weeks|Sample size was calculated under the assumption that at least 60% of the naltrexone-treated patients, and no more than 10% of the placebo-treated patients, would respond with at least a 70-point decline in CDAI scores. With a 10% withdrawal rate, 40 subjects yields an 86% power using a two-sided, 0.05-significance level Fisher’s exact test.||percentage of patients|||Number
764376|NCT00663117|Secondary|Percentage Change From Baseline of Quality of Life IBDQ (Inflammatory Bowel Disease Quality of Life Survey)|IBDQ (Inflammatory bowel Disease questionnaire) contains questions about health ranging from a score of poor (i.e., 32) to excellent (i.e., 224) an increase from baseline indicates improvement in quality of life.|Between baseline and 3 months|Same as sample size calculation||percentage of change||Standard Error|Mean
764377|NCT00663117|Primary|Percentage of Subjects Achieving a 70-point Decline in CDAI Scores (Crohn's Disease Activity Index) Scores;|The CDAI score is a number which consists of information collected from a 7-day diary from the patient regarding symptoms. It also includes objective information from the physical exam, weight and hemotocrit. Remission is considered a score of 150 or less. Active disease is considered 220 or greater. A response to therapy is considered a decline in the CDAI score of 70-points from baseline.|3 months|||percentage of pts|||Number
764378|NCT00663169|Secondary|Number of Patients Who Took Rescue Medication|Patients who did not improve by 72 hours post-dose (i.e. patients who show a pain Visual Analog (VAS) decrease of less than 50 % from baseline (Day 1, pre-dose) would have been treated with rescue medication of methylprednisolone 80 mg intravenous or intramuscular once at the discretion of the clinical investigator.|4 months|All participants.||Participants|||Number
764386|NCT00663169|Secondary|Non-inferiority of a Single Dose of Canakinumab Compared to Dexamethasone During Treatment Period||72 hours|Since the study only recruited 6 subjects this analysis was not done.|||||
764387|NCT00663169|Primary|Percentage of Participants With Improvement in Gout at 72 Hours Post-dose Using a Likert Scale|72 hours following treatment, patients were asked the question: “How would you rate the improvement in your gout since receiving the study medication?” Patients rated their improvement on the Likert 5-point scale: 1=Excellent, 2=Good, 3=Acceptable,4=Slight and 5=Poor. Improvement was assessed by determining patients who scored a “good” or “excellent” response.|72 hours|Pharmacodynamic set included all randomized subjects with evaluable (or complete) pharmacodynamic parameter data.||Percentage of participants|||Number
764388|NCT00663208|Secondary|Number of Participants Meeting Pre-Specified Criteria in Electrocardiogram Parameters|Pre-specified criteria were defined as, Heart rate (HR) minimum as <=50 bpm/change from baseline <-20 bpm/maximum HR >100 bpm, QT interval corrected using Fridericia's formula (QTcF) maximum as QTcF<=450 msec/450 msec <maximum QTcF and <=480 msec/480 msec <maximum QTcF <= 500 msec/maximum QTcF>500 msec, QRS interval as <=120 msec/>120 msec, and PR interval maximum as <= 200 msec/>200 msec.|Screening, Day 2, 3, 5, 7, 9, 11, 13, 15, 21 and 28|All participants treated with study drug were summarized.||participants|||Number
764389|NCT00663208|Secondary|Number of Participants With Clinically Relevant Change From Baseline in Vital Signs|Vital signs included: body temperature, respiratory rate, blood pressure (systolic and diastolic) and heart rate. Blood pressure and heart rate were measured after the participant had been supine, semi-supine, or seated quietly for at least 5 minutes. Baseline was defined as the last observation prior to dosing on Day 1.|Screening, Day -1 and prior to morning dose on Day 1, 2, 14, and 28|All participants treated with study drug were summarized.||participants|||Number
764390|NCT00663208|Secondary|Number of Participants With Marked Laboratory Abnormalities in Urinalysis|Marked laboratory abnormalities in urinalysis were defined as, Blood Urine High as >= 2*PreRx if PreRx >= 1/>= 2 if PreRx < 1/>= 2 if PreRx = Missing. Glucose Urine High as >= 1 if PreRx < 1/>= 1 if PreRx = Missing/>= 2*PreRx if PreRx >= 1.|Screening, Day 3, Day 7, Day 11, Day 14, and Day 28|All participants treated with study drug were summarized.||participants|||Number
764391|NCT00663208|Secondary|Number of Participants With Marked Laboratory Abnormalities in Lipase and Glucose|Marked abnormalities were defined as Lipase (U/L) High as >1.5*ULN, Glucose fasting serum (mg/dL) High as > 1.3*ULN if LLN <= PreRx <= ULN/> 1.3*ULN if PreRx = Missing/>2*PreRx; if PreRx > ULN/> ULN if PreRx < LLN.|Screening, Day 3, Day 7, Day 11, Day 14, and Day 28|All participants treated with study drug were summarized.||participants|||Number
764392|NCT00663208|Secondary|Number of Participants With Marked Abnormalities in Liver and Kidney Function Laboratory Tests and Electrolytes|Liver and kidney function marked laboratory abnormalities were defined as Alanine Aminotransferase (ALT) units per liter (U/L) High as > 1.25*PreRx if PreRx > ULN/> 1.25*ULN if PreRx <= ULN/> 1.25*ULN if PreRx = Missing, Aspartate Aminotransferase (AST) U/L High as > 1.25* PreRx if PreRx > ULN/> 1.25*ULN if PreRx <= ULN/> 1.25*ULN if PreRx = Missing, Alkaline Phosphatase(ALP)U/L High as > 1.25*PreRx if PreRx > ULN/> 1.25*ULN if PreRx <= ULN/> 1.25*ULN if PreRx = Missing, G-Glutamyl Transferase (GGT) in U/L High as >1.15*ULN if PreRx<=ULN/>1.15* if PreRx missing/>1.2* PreRx if PreRx>ULN, Phosphorus Inorganic (mg/dL) Low as < 0.85*LLN if LLN <= PreRx <= ULN/< 0.85*LLN if PreRx = Missing/< 0.85*PreRx if PreRx < LLN/< LLN if PreRx > ULN, and Potassium serum milliequivalents per liter (mEq/L) High as > 1.1*PreRx if PreRx > ULN/> 1.1*ULN if LLN <= PreRx <= ULN/> 1.1*ULN if PreRx = Missing/> ULN if PreRx < LLN.|Screening, Day 3, Day 7, Day 11, Day 14, and Day 28|All participants who were treated with study drug were summarized.||participants|||Number
764393|NCT00663208|Secondary|Number of Participants With Marked Laboratory Abnormalities in Hematology|Hematology marked laboratory abnormalities were defined as Hemoglobin (g/dL) Low as < 0.85*Pre-therapy (PreRx), Hematocrit (%) Low as < 0.85*PreRx, Platelet Count *10^9 c/L Low as < 0.85*Lower Limits of Normal (LLN) if PreRx = Missing/< 0.85*LLN if PreRx >= LLN/< 0.85*PreRx if PreRx < LLN, Eosinophils (absolute) *10^3 c/µL High as > 0.75*count, Leukocytes White Blood Cell (WBC) *10^3 c/µL High as > 1.2*ULN if LLN <= PreRx <= Upper Limits of Normal (ULN) > 1.2*ULN if PreRx = Missing/> 1.5*PreRx if PreRx > ULN/> ULN if PreRx < LLN.|Screening, Day 3, Day 7, Day 11, Day 14, and Day 28|All participants treated with study drug were summarized.||participants|||Number
764394|NCT00663208|Secondary|Number of Participants With Serious Adverse Events (SAEs), Discontinuation Due to Adverse Events (AEs), and Who Died|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|Day 1 to Day 182 or Day of Discharge|All participants who received study drug were summarized.||participants|||Number
764395|NCT00663208|Secondary|Correlation Coefficients Between Measures of Decline in log10 Hepatitis C Virus (HCV) RNA and Daclatasvir PK Parameters Cmax, AUC(TAU), and Cmin on Day 14 in Participants Without Baseline Drug Resistance|Correlation between decline of log10 hepatitis C virus (HCV) RNA and exposure to study drug was measured by Pearson Correlation Coefficients. The change from baseline at Day 4 in log10 HCV RNA and the maximum decline in log10 HCV RNA were evaluated against the PK parameters Cmax, Cmin and AUC(TAU).|Day 4, Day 14|All participants who received at least 1 dose of daclatasvir and who had no baseline genotype resistance were analyzed. Placebo participants were excluded from this analysis.||Correlation Coefficient|||Number
764396|NCT00663208|Secondary|Time of Maximum Observed Plasma Concentration (Tmax) of Daclatasvir on Days 1 and 14|Tmax was defined as the time to reach maximum observed plasma concentration of daclatasvir in plasma. Tmax was derived from plasma concentration-time data analyzed by non-compartmental methods. Tmax of daclatasvir in plasma was assayed using a validated liquid chromatography tandem mass spectrometry method.|0 hour (pre-dose) 0.5, 1,1.5, 2, 3, 4, 6, 8 and 12 hours (post morning dose) at Day1 and Day 14, 0 hour (pre-dose) at Days 2, 3, 4, 5, 7, 9, 11, 13, and 24, 48 and 72 hours (post morning dose) at Day 14|All participants who received at least 1 dose of study medication and with available PK data were summarized.||h||Full Range|Median
764408|NCT00663208|Primary|Change From Baseline at Day 7 in log10 Hepatitis C Virus (HCV) RNA of All Participants|The Roche TaqMan HCV quantitative assay was used for analysis with detection limit of 10 IU/mL. Baseline was Day -1.|Baseline, Day 7|All randomized participants who took at least 1 dose of study medication.||log10 IU/mL||90% Confidence Interval|Mean
764625|NCT00665925|Secondary|Alanine Aminotransferase (ALT) >3x Upper Limit of Normal (ULN)|The number of participants with ALT (a test of liver function) values greater than 3 times the ULN|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.||Participants|||Number
764397|NCT00663208|Secondary|Accumulation Index (AI) AUC(TAU), AI Cmax, and Degree of Fluctuation (DF) of Daclatasvir on Day 14|Accumulation index area under the concentration–time curve of daclatasvir to the end of the dosing period [AI AUC(TAU)] was defined as the ratio of AUC(TAU) at steady-state to AUC(TAU) after the first dose.Accumulation index maximum observed concentration of daclatasvir in plasma (AI Cmax) was defined as the ratio of Cmax at steady-state to Cmax after the first dose. Degree of Fluctuation (DF) was defined as the ratio of difference between Cmax and Cmin at steady state by Css-av. The parameters were analyzed using non-compartmental methods, assayed by validated liquid chromatography tandem mass spectrometry (LC-MS/MS).|0 hour (pre-dose) 0.5, 1,1.5, 2, 3, 4, 6, 8 and 12 hours (post morning dose) at Day1 and Day 14, 0 hour (pre-dose) at Days 2, 3, 4, 5, 7, 9, 11, 13, and 24, 48 and 72 hours (post morning dose) at Day 14|All participants who received at least 1 dose of study medication and with available PK data were summarized.||ratio||Geometric Coefficient of Variation|Geometric Mean
764398|NCT00663208|Secondary|Average Observed Plasma Concentration (Css-av) at Steady State of Daclatasvir at Days 1 and 14|The average observed plasma concentration at steady state (Css-av) was calculated as ratio of AUC(TAU) by TAU, where TAU = 24 h for QD dosing and 12 h for BID dosing. Css-av was derived from plasma concentration-time data analyzed by non-compartmental methods. Css-av of daclatasvir in plasma was assayed using a validated liquid chromatography tandem mass spectrometry method.|0 hour (pre-dose) 0.5, 1,1.5, 2, 3, 4, 6, 8 and 12 hours (post morning dose) at Day1 and Day 14, 0 hr (pre-dose) at Days 2, 3, 4, 5, 7, 9, 11,13, and 24, 48 and 72 hours (post morning dose) at Day 14|All participants who received at least 1 dose of study medication and with available PK data were summarized.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
764399|NCT00663208|Secondary|Apparent Total Body Clearance (CLT/F) of Daclatasvir on Day 14|The apparent total body clearance at steady state (CLT/F) was defined as the apparent body clearance of canakinumab from the serum when the systemic availability was unknown. CLT/F was derived from plasma concentration-time data analyzed by non-compartmental methods. CLT/F of daclatasvir in plasma was assayed using a validated liquid chromatography tandem mass spectrometry method.|0 hour (pre-dose) 0.5, 1,1.5, 2, 3, 4, 6, 8 and 12 hours (post morning dose) at Day1 and Day 14, 0 hour (pre-dose) at Days 2, 3, 4, 5, 7, 9, 11, 13, and 24, 48 and 72 hours (post morning dose) at Day 14|All participants who received at least 1 dose of study medication and with available PK data were summarized.||mL/min||Geometric Coefficient of Variation|Geometric Mean
764400|NCT00663208|Secondary|Plasma Half-life (T-half) of Daclatasvir at Day 14|The absolute values of lamda (λ) were used to evaluate apparent terminal half-life (T-half) was defined as T-half= ln 2/λ. T-half was derived from plasma concentration-time data analyzed by non-compartmental methods. T-half of daclatasvir in plasma was assayed using a validated liquid chromatography tandem mass spectrometry method.|0 hour (pre-dose) 0.5, 1,1.5, 2, 3, 4, 6, 8 and 12 hours (post morning dose) at Day1 and Day 14, 0 hr (pre-dose) at Days 2, 3, 4, 5, 7, 9, 11, 13, and 24, 48 and 72 hours (post morning dose) at Day 14|All participants who received at least 1 dose of study medication and with available PK data were summarized.||h||Standard Deviation|Mean
764401|NCT00663208|Secondary|Area Under the Concentration-time Curve (AUC) in 1 Dosing Interval of Daclatasvir at Days 1 and 14|The area under the concentration-time curve in 1 Dosing Interval AUC(TAU) was used to measure the drug exposure over 1 dosing interval., derived from plasma concentration-time data analyzed by non-compartmental methods. AUC(TAU) of daclatasvir in plasma was assayed using a validated liquid chromatography tandem mass spectrometry method.|0 hour (pre-dose) 0.5, 1,1.5, 2, 3, 4, 6, 8 and 12 hours (post morning dose) at Day1 and Day 14, 0 hr (pre-dose) at Days 2, 3, 4, 5, 7, 9, 11, 13, and 24, 48 and 72 hours (post morning dose) at Day 14|All participants who received at least 1 dose of study medication and with available PK data were summarized.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
764402|NCT00663208|Secondary|Maximum Observed Plasma Concentration (Cmax) and Minimum Observed Plasma Concentration (Cmin) of Daclatasvir on Days 1 and 14|The peak concentrations in plasma (Cmax) and minimum observed plasma concentration (Cmin) were defined as the peak maximum and minimum plasma level of daclatasvir, derived from plasma concentration-time data analyzed by non-compartmental methods. Cmax and Cmin of daclatasvir in plasma was assayed using a validated liquid chromatography tandem mass spectrometry method.|0 hour (pre-dose) 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours (post morning dose) at Day1 and Day 14, 0 hour (pre-dose) at Days 2, 3, 4, 5, 7, 9, 11, 13 and 24, 48 and 72 hours (post morning dose) at Day 14|All participants who received at least 1 dose of study medication and with available Pharmacokinetic (PK) data were summarized.||nanograms/milliliters(ng/mL)||Geometric Coefficient of Variation|Geometric Mean
764403|NCT00663208|Secondary|Maximum Decline From Baseline in Log10 Hepatitis C Virus (HCV) RNA in Participants Without Baseline Drug Resistance|The Roche TaqMan HCV quantitative assay was used for analysis with detection limit of 10 IU/mL.|Day 1 up to Day 14|All randomized participants who took at least 1 dose of study medication and did not have baseline genotypic drug resistance mutations.||log10 IU/mL||Standard Deviation|Mean
764404|NCT00663208|Secondary|Time to Maximum Decline From Baseline in Hepatitis C Virus (HCV) RNA in Participants Without Baseline Drug Resistance|Participants without baseline drug resistance were assessed for time to reach maximum decrease in log10 HCV RNA level.|Day 1 up to Day 14|All randomized participants who took at least 1 dose of study medication and did not have baseline genotypic drug resistance mutations.||Days||Standard Deviation|Mean
764405|NCT00663208|Secondary|Change From Baseline to Day 14 in Log10 Hepatitis C Virus (HCV) RNA in Participants Without Baseline Drug Resistance|The Roche TaqMan HCV quantitative assay was used for analysis with detection limit of 10 IU/mL. Baseline was Day -1.|Baseline to Day 14|All randomized participants who took at least 1 dose of study medication and did not have baseline genotypic drug resistance mutations.||log10 IU/mL||90% Confidence Interval|Mean
764406|NCT00663208|Secondary|Change From Baseline to Day 4 in log10 Hepatitis C Virus (HCV) RNA in Participants Without Baseline Drug Resistance|The Roche TaqMan HCV quantitative assay was used for analysis with detection limit of 10 IU/mL. Baseline was Day -1.|Baseline to Day 4|All randomized participants who took at least 1 dose of study medication and did not have baseline genotypic drug resistance mutations.||log10 IU/mL||90% Confidence Interval|Mean
764407|NCT00663208|Secondary|Change From Baseline at 24 h Post Dose on Day 1 in log10 Hepatitis C Virus (HCV) RNA of Participants Without Baseline Drug Resistance|The Roche TaqMan HCV quantitative assay was used for analysis with detection limit of 10 IU/mL. Baseline was Day -1.|Baseline, 2, 4, 6, 8, 12, 16, 20, and 24 hours post dose on Day 1|All randomized participants who took at least 1 dose of study medication and did not have baseline genotypic drug resistance mutations were summarized.||log10 IU/mL||Standard Deviation|Mean
764409|NCT00663208|Secondary|Change From Baseline at Day 7 in log10 Hepatitis C Virus (HCV) RNA Levels of Participants Without Baseline Drug Resistance|The Roche TaqMan HCV quantitative assay was used for analysis with detection limit of 10 international units/ millilitre (IU/mL). Baseline was Day -1|Baseline, Day 7|All randomized participants who took at least 1 dose of study medication.||log10 IU/mL||90% Confidence Interval|Mean
764410|NCT00663234|Primary|Percentage of Participants Experiencing at Least One Adverse Event (AE) by Age Group|AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (see references in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening, Grade 5=Death. The primary outcome measure includes any AE of grade 3 or higher and liver function tests (LFTs) of grade 2 or higher.|Study entry to weeks 12, 24, and 48|All participants who initiated Atorvastatin.||percentage of participants||90% Confidence Interval|Number
764411|NCT00663234|Primary|Percentage of Participants Experiencing at Least One Treatment-related Adverse Event (AE) by Age Group|AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (see references in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening, Grade 5=Death. Relationship to study treatment was determined by the core study team. The primary outcome measure includes any AE of grade 3 or higher and liver function tests (LFTs) of grade 2 or higher.|Study entry to weeks 12, 24, and 48|All participants who initiated Atorvastatin.||percentage of participants||90% Confidence Interval|Number
764412|NCT00663234|Secondary|Percentage of Participants With Undetectable Plasma HIV-1 RNA|Undetectable is defined as plasma HIV-1 RNA below the lower limit of quantification of the assay used.|Study entry and weeks 12, 24, and 48|All study participants who initiated Atorvastatin and had HIV-1 RNA data available at the specified week.||percentage of participants||90% Confidence Interval|Number
764413|NCT00663234|Secondary|Percent Change in Interleukin 6 (IL-6) From Study Entry||Study entry and weeks 12, 24, and 48|All participants who initiated Atorvastatin and had IL-6 data available at study entry and the specified week.||percentage of IL-6 at study entry||90% Confidence Interval|Median
764414|NCT00663234|Secondary|Percent Change in High-sensitivity CRP (Hs-CRP) From Study Entry||Study entry and weeks 12, 24, and 48|All participants who initiated Atorvastatin and had hs-CRP data available at study entry and the specified week.||percentage of hs-CRP at study entry||90% Confidence Interval|Median
764415|NCT00663234|Secondary|Percent Change in Apolipoprotein B (Apo B) From Study Entry||Study entry and weeks 12, 24, and 48|All participants who initiated Atorvastatin and had Apo B data available at study entry and the specified week.||percentage of Apo B at study entry||90% Confidence Interval|Mean
764416|NCT00663234|Secondary|Percent Change in Apolipoprotein A1 (Apo A-1) From Study Entry||Study entry and weeks 12, 24, and 48|All participants who initiated Atorvastatin and had Apo A-1 data available at study entry and the specified week.||percentage of Apo A-1 at study entry||90% Confidence Interval|Mean
764417|NCT00663234|Secondary|Percent Change in HDL-cholesterol (HDL-C) From Study Entry||Study entry and weeks 4, 12, 24, and 48|All participants who initiated Atorvastatin and had HDL-C data available at study entry and the specified week.||percentage of HDL-C at study entry||90% Confidence Interval|Mean
764418|NCT00663234|Secondary|Percent Change in Triglycerides (TG) From Study Entry||Study entry and weeks 4, 12, 24, and 48|All participants who initiated Atorvastatin and had triglycerides data available at study entry and the specified week.||percentage of TG at study entry||90% Confidence Interval|Mean
764419|NCT00663234|Secondary|Percent Change in Fasting Total Cholesterol (TC) From Study Entry||Study entry and weeks 4, 12, 24, and 48|All participants who initiated Atorvastatin and had total cholesterol data available at study entry and the specified week.||percentage of TC at study entry||90% Confidence Interval|Mean
764420|NCT00663234|Primary|Percent Change in LDL Cholesterol (LDL-C) From Study Entry||Study entry and weeks 4, 12, 24, and 48|All participants who initiated Atorvastatin and had LDL-C data available at study entry and the specified week.||percentage of LDL-C at study entry||90% Confidence Interval|Mean
764421|NCT00663234|Primary|Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria by NNRTI Treatment|Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week.|Study entry and weeks 4, 12, 24, and 48|All participants who initiated Atorvastatin. If a participant was missing data at a given week, treatment was assumed to be non-efficacious at that week.||percentage of participants||90% Confidence Interval|Number
764422|NCT00663234|Primary|Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria by Age Group|Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week.|Study entry and weeks 4, 12, 24, and 48|All participants who initiated Atorvastatin. If a participant was missing data at a given week, treatment was assumed to be non-efficacious at that week.||percentage of participants||90% Confidence Interval|Number
764423|NCT00663234|Primary|Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria and Did Not Experience a Primary Safety Endpoint Attributable to Study Drug|Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week.|Study entry and weeks 4, 12, 24, and 48|All participants who initiated Atorvastatin and did not experience a primary safety event attributable to Atorvastatin.||percentage of participants||90% Confidence Interval|Number
764424|NCT00663234|Primary|Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria (Per Protocol)|Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week.|Study entry and weeks 4, 12, 24, and 48|All participants who completed the study per protocol (initiated study drug, had LDL-C data available at all required study visits, attended study visits within the protocol-specified window, were dose-escalated according to protocol, and reported adherence to study drug at all study visits).||percentage of participants||90% Confidence Interval|Number
764425|NCT00663234|Primary|Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria (Data Available)|Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week.|Study entry and weeks 4, 12, 24, and 48|All participants who initiated study treatment and have LDL-C data available at study entry and the specified week.||percentage of participants||90% Confidence Interval|Number
764985|NCT00673153|Secondary|Number of Participants Achieving CR or CRi With Induction Therapy (Poor-risk Group)||after completion of induction therapy, administered every 21-42 days for up to two courses|Poor-risk Group: patients aged ≥70 years and performance status 2-3||Participants|||Count of Participants
764426|NCT00663234|Primary|Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria (Intention to Treat)|Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week.|Study entry and weeks 4, 12, 24, and 48|All participants who initiated Atorvastatin. If a participant was missing data at a given week, treatment was assumed to be non-efficacious at that week.||percentage of participants||90% Confidence Interval|Number
764427|NCT00663234|Primary|Percentage of Participants Experiencing at Least One Adverse Event (AE)|AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (see references in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening, Grade 5=Death. The primary outcome measure includes any AE of grade 3 or higher and liver function tests (LFTs) of grade 2 or higher.|Study entry to weeks 12, 24, and 48|All participants who initiated Atorvastatin.||percentage of participants||90% Confidence Interval|Number
764428|NCT00663234|Primary|Percentage of Participants Experiencing at Least One Treatment-related Adverse Event (AE)|AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (see references in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening, Grade 5=Death. Relationship to study treatment was determined by the core study team. The primary outcome measure includes any AE of grade 3 or higher and liver function tests (LFTs) of grade 2 or higher.|Study entry to weeks 12, 24, and 48|All participants who initiated Atorvastatin.||percentage of participants||90% Confidence Interval|Number
764429|NCT00663260|Secondary|Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 8, 12, 16, 20, and 24 of the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing body weight values at baseline and Week 24 (LOCF)||kg||Standard Error|Mean
764430|NCT00663260|Secondary|Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Fasting plasma glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24 in the double-blind period|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing FPG values at baseline and Week 24 (LOCF)||mg/dL||Standard Error|Mean
764431|NCT00663260|Primary|Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF]|HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24 in the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing HbA1c values at baseline and Week 24 (LOCF)||% of hemoglobin||Standard Error|Mean
764432|NCT00663403|Secondary|Daptomycin Free Fraction|"In the body, daptomcyin may be bound to proteins in the blood or it may not be bound to any proteins (also as the free component.) Free fraction describes the percent of daptomycin that is unbound or free. The unbound portion of daptomycin is able to kill bacteria."|From time of daptomycin administration to 48 hours post dose|||percent protein binding||Standard Deviation|Mean
764433|NCT00663403|Secondary|Daptomycin Half-life|Half-life describes the time it takes for the concentration of the daptomycin in the body to decrease by one half.|From time of daptomycin administration to 48 hours post dose when subjects were also receiving continuous venovenous hemodialysis|||hours||Standard Deviation|Mean
764434|NCT00663403|Secondary|Daptomycin Total Body Clearance|Total body clearance represents the rate at which daptomycin is removed from the body. In patients treated with continuous venovenous hemodialysis, the major pathways of daptomycin removal likely are: removal by continuuous venovenous hemodialysis (transmembrane clearance) and breakdown by the liver.|From time of daptomycin administration to 48 hours post dose when subjects were also receiving continuous venovenous hemodialysis|||mL/min/kg||Standard Deviation|Mean
764435|NCT00663403|Secondary|Daptomycin Volume of Distribution at Steady State|Volume of distribution quantifies the distribution of daptomycin between the blood and the rest of the body. The greater the volume of distribtion, the greater the extent of daptomycin distribution throughout the body.|From time of daptomycin administration to 48 hours post dose|||L/kg||Standard Deviation|Mean
764436|NCT00663403|Secondary|Observed Daptomycin Peak Serum Concentration|The maximum concentration of daptomycin in the body after receiving a dose of the drug. This was determined at the end of the daptomycin intravenous infusion at approximately 30 min.|At the end of the daptomycin intravenous infusion (at approximately 30 minutes)|||ug/mL||Standard Deviation|Mean
764437|NCT00663403|Secondary|Daptomycin Dose Actually Administered||Time of daptomycin administration|||mg/kg||Standard Deviation|Mean
764438|NCT00663403|Primary|Daptomycin Transmembrane Clearance by Continuous Venovenous Hemodialysis|Quantifies the rate of daptomcyin removal by continuous venovenous hemodialysis.|From time of daptomycin administration to 48 hours post dose when subjects were also receiving continuous venovenous hemodialysis|||mL/min||Standard Deviation|Mean
764439|NCT00663702|Primary|Mean Temperature|Temperature was measured after the patient had been seated quietly for at least 5 minutes and recorded during the screening visit, during every office visit prior to administration of subcutaneous injections, and at study discharge or 7 days after the last dose for patients who terminated early.|Before injection on Days 1, 29, 57, 85, 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1177, 1261, 1345, 1457, 1541, 1625, 1709, and 1821|All participants who received at least 1 dose of study medication. n=patients evaluable||Degrees Celsius||Standard Deviation|Mean
764440|NCT00663702|Primary|Mean Heart Rate|Heart rate was measured after the patient had been seated quietly for at least 5 minutes and recorded during the screening visit, during every office visit prior to administration of subcutaneous injections, and at study discharge or 7 days after the last dose for patients who terminated early.|Before injection on Days 1, 29, 57, 85, 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1177, 1261, 1345, 1457, 1541, 1625, 1709, and 1821|All participants who received at least 1 dose of study medication. n=patients evaluable||Beats per minute||Standard Deviation|Mean
764441|NCT00663702|Primary|Mean Sitting Systolic and Diastolic Blood Pressure (BP)|BP was measured after the patient had been seated quietly for at least 5 minutes and recorded during the screening visit, during every office visit prior to administration of subcutaneous injections, and at study discharge or 7 days after the last dose for patients who terminated early.|Before injection on Days 1, 29, 57, 85, 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1177, 1261, 1345, 1457, 1541, 1625, 1709, and 1821|All participants who received at least 1 dose of study medication. n=patients evaluable||mm Hg||Standard Deviation|Mean
764442|NCT00663702|Primary|Number of Participants With Adverse Events of Special Interest|AEs of special interest are AEs that may be associated with the use of immunomodulatory drugs, such as infections, malignancies, autoimmune disorders, and injection reactions (defined as local injection site reactions and systemic injection reactions occurring within 24 hours of subcutaneous injection).|Day 1 (Baseline) to up to 56 days past the last day of subcutaneous injection in the cumulative study period|All participants who received at least 1 dose of study medication.||Participants|||Number
764443|NCT00663702|Primary|Participants With Urinalysis Values Meeting the Criteria for Marked Abnormality|preRX=pretreatment. For all values analyzed (protein, urine; glucose, urine; blood, urine: leukocyte esterase, urine; white blood cells, urine; red blood cells, urine): If missing preRx, use >=2 or, if value >= 4, or if preRx=0 or 0.5, use >=2 or, if preRx= 1, use >=3 or, if preRx=2 or 3, use >=4.|Day 1 (Baseline) through 56 days past last day of subcutaneous injection in the cumulative study period|All participants who received at least 1 dose of study medication. n=patients evaluable||Participants|||Number
764444|NCT00663702|Secondary|Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores Over Time|The HAQ-DI assesses patients' functional ability by rating their abilities over the previous week. At least 2 questions are asked from each of 8 categories: dressing and grooming, hygiene, arising, reach, eating, grip, walking, and common daily activities. Patients rate difficulty performing specific tasks: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The sum of the categories is divided by the number of categories answered, yielding a score from 0-3.|Day 1 (Baseline) to Day 1093|All participants who received at least 1 dose of study medication||Units on a scale||Standard Deviation|Mean
764445|NCT00663702|Secondary|Percentage of Participants With Low Disease Activity Score (LDAS) and Disease Activity Score 28 Based on C-reactive Protein (DAS 28-CRP) Remission Over Time:|LDAS is defined as DAS 28-CRP ≤3.2. DAS 28-CRP remission is defined as DAS 28-CRP <2.6. The DAS 28-CRP is a measure of disease activity in rheumatoid arthritis (RA) and assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), C-reactive protein level (a measure of inflammation in the blood), and the patient’s global assessment of health (ranging from very good to very bad). DAS-CRP scores range from 0 to 10, with higher values indicating greater disease activity. Individual measures are fed into a complex mathematical formula to produce the overall DAS (a score greater than 5.1 implies active disease; less than 3.2, well controlled disease; and less than 2.6, remission.)|Day 1 (Baseline) through Day 1093|All participants who received at least 1 dose of study medication||Percentage of participants||95% Confidence Interval|Number
764446|NCT00663702|Secondary|Mean Disease Activity Score 28 Based on C-reactive Protein (DAS 28-CRP) Scores Over Time|The DAS 28-CRP is a measure of disease activity in rheumatoid arthritis (RA) and assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), C-reactive protein level (a measure of inflammation in the blood), and the patient’s global assessment of health (ranging from very good to very bad). DAS-CRP scores range from 0 to 10, with higher values indicating greater disease activity. Individual measures are fed into a complex mathematical formula to produce the overall DAS (a score greater than 5.1 implies active disease; less than 3.2, well controlled disease; and less than 2.6, remission.)|Day 1 (Baseline) through Day 1093|All participants who received at least 1 dose of study medication||Units on a scale||Standard Deviation|Mean
764447|NCT00663702|Secondary|Percentage of Participants With A Positive Anti-abatacept Response (Based on Electrochemiluminescence [ECL] Immunoassay) at Day 85|"Number of participants was tabulated using ECL assay with at least 1 positive abatacept-induced immunogenic response (CTLA4 and possibly Ig, Ig and/or Junction Region) in the first 85 days. Positive response (titers >10) included:
A missing baseline immunogenicity measurement and a positive immunogenicity response postbaseline
A negative baseline immunogenicity response and a positive immunogenicity response postbaseline
A positive baseline immunogenicity response and a positive immunogenicity response postbaseline that has a titer value strictly greater than the baseline titer value"|Day 1 (Baseline) through Day 85|All participants who received at least 1 subcutaneous abatacept injection and who had at least 1 immunogenicity result reported (on the corresponding assay) on subcutaneous abatacept treatment. n=patients evaluable||Percentage of participants|||Number
764448|NCT00663702|Secondary|Percentage of Participants With A Positive Anti-abatacept Response (Based on Enzyme-linked Immunosorbent Assay [ELISA]) at Day 85|Using the ELISA, any positive (titer of 400 or greater) postbaseline sample was classified as positive immunogenicity. The percentage of participants with at least 1 positive antibody response (anti-abatacept and/or anti-CTLA4-T) during the 85 days was tabulated by antibody specificity and overall.|Day 1 (Baseline) through Day 85|All participants who received at least 1 subcutaneous abatacept injection and who had at least 1 immunogenicity result reported (on the corresponding assay) on subcutaneous abatacept treatment. n=patients evaluable||Percentage of participants|||Number
764449|NCT00663702|Primary|Number of Participants With Chemistry Laboratory Values Meeting the Criteria for Marked Abnormality|LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Criteria for marked abnormality: .|Day 1 (Baseline) to up to 56 days past the last day of subcutaneous injection in the cumulative study period|All participants who received at least 1 dose of study medication. n=patients evaluable||Participants|||Number
764450|NCT00663702|Primary|Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality|LLN=lower limit of normal; ULN=upper limit of normal; preRx=pretreatment. Sodium: <0.95*LLN or >1.05*ULN or if preRx<LLN, <0.95*preRx or >ULN, or if preRx>ULN,>1.05*preRx or <LLN. Potassium,serum: <0.9*LLN or >1.1*ULN or if preRx<LLN, use <0.9*preRx or >ULN or if preRx>ULN, 1.1*preRx or <LLN. Phosphorus: 0.75*LLN or 1.25*ULN or, if preRx<LLN, <0.67*preRx or >ULN or, if preRx>ULN, <LLN.|Day 1 (Baseline) through 56 days past last day of subcutaneous injection in the cumulative study period|All participants who received at least 1 dose of study medication. n=patients evaluable||Participants|||Number
764451|NCT00663702|Primary|Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality|LLN=lower limit of normal; ULN=upper limit of normal; preRx=pretreatment. Marked abnormality criteria: Alkaline phosphatase (U/L) >2*ULN or if preRx>ULN, use 3*preRx. Alanine aminotransferase (U/L)>3*ULN or if preRx>ULN, use >4*preRx. G-glutamyl transferase (U/L)>2*ULN or if preRx>ULN, use >3*preRx. Blood urea nitrogen (mg/dL)>2*preRx. Creatinine (mg/dL)>1.5*preRx.|Day 1 (Baseline) through 56 days past last day of subcutaneous injection in the cumulative study period|All participants who received at least 1 dose of study medication. n=patients evaluable||Participants|||Number
764452|NCT00663702|Primary|Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality|LLN=lower limit of normal; ULN=upper limit of normal; preRx=pretreatment. Marked abnormality criteria: Hemoglobin (g/dL) >3 decrease from preRx. Hematocrit (%)<0.75*preRx. Erythrocytes (*10^6 c/uL) <0.75*preRx. Platelet count (*10^9 c/L) <0.67*LLN or 1.5*ULN or, if preRx<LLN, use <0.5*preRx and <100,000 mm^3. Leukocytes (*10^3 c/uL) <0.75*LLN or >1.25*ULN or, if preRx<LLN, use <0.8*preRx or >ULN or, if preRx>ULN, use >1.2*preRx or <LLN. Eosinophils >0.750*10^3 c/uL. Lymphocytes <0.750*10^3 c/uL or >7.50*10^3 c/uL.|Day 1 (Baseline) through 56 days past last day of subcutaneous injection in the cumulative study period|All participants who received at least 1 dose of study medication. n=patients evaluable||Participants|||Number
764453|NCT00663702|Primary|Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Treatment-related Adverse Events (AEs), and AEs Leading to Discontinuation|An AE is a new or worsening illness, sign, or symptom or a clinically significant abnormal laboratory test result occurring during the study, regardless of causality, and noted by the investigators.|Day 1 (Baseline) through 56 days past last day of subcutaneous injection in the cumulative study period|All participants who received at least 1 dose of study medication||Participants|||Number
764454|NCT00663702|Secondary|Mean Trough Serum Concentration (Cmin) of Abatacept|Cmin of abatacept was determined from serum samples.|Days 29, 85, 57, and 85|All participants who received at least 1 dose of study medication. n=patients who had at least 1 pharmacokinetic sample drawn postbaseline||μg/mL||Geometric Coefficient of Variation|Geometric Mean
764455|NCT00663702|Primary|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Treatment-related Adverse Events (AEs), AEs Leading to Discontinuation, and AEs of Interest (AEIs) at Day 85|An AE is a new or worsening illness, sign, or symptom or a clinically significant abnormal laboratory test result occurring during the study, regardless of causality, and noted by the investigators. Systemic injection reaction occurring ≤ 24 hours after dosing.|Day 1 (Baseline) through Day 85|All participants who received at least 1 dose of study medication||Participants|||Number
764456|NCT00663793|Secondary|Area Under the Curve-E2||14 Days|||nmol*h/L||Standard Deviation|Mean
764457|NCT00663793|Secondary|Area Under the Curve-serum DHT||14-days|||nmol*h/L||Standard Error|Mean
764458|NCT00663793|Primary|Area Under the Curve-Serum T||14 days|||nmol*h/L||Standard Error|Mean
764459|NCT00663819|Secondary|Determine the Efficacy and Further Substantiate Safety of CBSG Used in Conjunction With Circular Staplers When Performing High-risk Colorectal, Coloanal, and Ileoanal Anastomoses.||study completion||||||
764460|NCT00663819|Secondary|Provide a Cost/Benefit Analysis With Regard to the Use of CBSG in Stapled Circular Anastomoses||study completion||||||
764461|NCT00663819|Secondary|Determine the Rate of Significant Staple Line Hemorrhage With and Without the Use of CBSG in Circular Stapled Anastomoses||post operative||||||
764462|NCT00663819|Secondary|Identify and Compare the Rate of Anastomotic Stenosis Associated With Circular Stapled Anastomoses Constructed With and Without CBSG.||post operative||||||
764463|NCT00663819|Primary|Proportion of Subjects Who Experience a Clinical and/or Radiologic Anastomotic Leak|The primary endpoint for the study is the proportion of subjects who experience a clinical and/or radiologic anastomotic leak through 4 - 12 weeks post procedure.|completion of procedure through 4-12 weeks post procedure|||percentage of subjects|||Number
764464|NCT00663858|Primary|International Prostate Symptom Score (IPSS)|IPSS score of BPH symptoms based on a patient questionnaire assessing 7 items (incomplete voiding, frequency, intermittency, urgency, weak stream, hesitancy, nocturia) on a scale from 0 (best) to 5 (worst); total overall score range: 0 points (best) to 35 points (worst)|Baseline and 52 weeks|||Units on a scale||Standard Deviation|Mean
764465|NCT00663923|Secondary|Surgically Induced Astigmatism|"It is the vector of the astigmatic change actually induced by the surgery.Participant population was the same as baseline participants.
It was measured by refraction(using autorefractor) and vector analysis(using special software).Diopter is a unit of measurement of the optical power of any refracting surface ,which is reciprocal of the focal length measured in meters"|six months after surgery|||Diopter||Standard Deviation|Mean
764466|NCT00663923|Secondary|Uncorrected Distance Visual Acuity (UCDVA)|UCDVA is attained without correction of refractive errors .the data are the LogMAR values calculated from the snellen chart using the visual acuity conversion chart( the units would be LogMAR).Any patient with better vision can see the smallest letters at 20 feet(20/20=0.00 LogMAR).Higher LogMAR values represent worse outcome.Log MAR(logarithmic minimum angle of resolution)notation ,has gained widespread use in statistical calculations.|six months|the analysis was per protocol||LogMAR|Participants|Standard Deviation|Mean
772078|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 1|Subject Satisfaction - overall function|12 months post-surgery|||% satisfactory or somewhat satisfactory|||Number
764467|NCT00663923|Secondary|Corrected Distance Visual Acuity(CDVA)|CDVA is attained after correction of refractive errors using lenses of varying powers .the data are the LogMAR values calculated from the snellen chart using the visual acuity conversion chart(the units would be LogMAR).Any patient with better vision can see the smallest letters at 20 feet(20/20=0.00 LogMAR).Higher LogMAR values represent worse outcome.Log MAR(logarithmic minimum angle of resolution)notation ,has gained widespread use in statistical calculations.|six months|the analysis was per protocol||LogMAR|Participants|Standard Deviation|Mean
764468|NCT00663923|Secondary|Higher Order Aberrations|Although lower- order aberrations decrease after laser vision correction,higher -order aberrations may increase after conventional PRK or LASIK(Laser in situ keratomileusis).Higher-order aberration is Composed of delicate irregularities within the cornea not correctable by spectacles.It is measured using aberrometer.In this study OPD scan was used that is one of the methods of wavefront analysis .|six months postoperative|the analysis was per protocol.||micron|Participants|Standard Deviation|Mean
764469|NCT00663923|Primary|Correction of Astigmatism|It shows the result of correction of astigmatism .In compound myopic astigmatism the meridians of maximum and minimum power are both too strong.So both line images fall short of the retina.It is measured by refraction(using autorefractor).Diopter is a unit of measurement of the optical power of any refracting surface ,which is reciprocal of the focal length measured in meters.|six months after surgery|"The sample size was determined by the one proportion formula where power = 0.8, d=0.02 , p= 0.5(primary outcome) and type I error probability associated with this test of null hypothesis is 0.05.
The analysis was per protocol"||diopter|Participants|Standard Deviation|Mean
764470|NCT00663962|Primary|Incidence of Chronic Post-thoracotomy Pain at 2 Months Postoperatively|Incidence of post-thoracotomy pain syndrome (persistent continuous or intermittent chest pain with resting pain score > 4 on a 10 point NRS scale)|2 months postoperatively|pilot study--convenience||participants|||Number
764471|NCT00663962|Primary|The Primary Outcome Measure for the Final Study Will be the Incidence of CPTPS at 2 Months.||2, 4, and 6 months||||||
764472|NCT00664326|Other Pre-specified|Duration of Stable Disease (Update)|Duration of SD was calculated as the time from the first date of receiving study drug until the date of documented PD or the last observation if the subject did not progress. Subjects without disease progression at the time of analysis were censored at the last date of tumor evaluation.|From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeks|Subjects from ITT population who achieved objective response of CR or PR were excluded from this evaluation.||Days||95% Confidence Interval|Median
764473|NCT00664326|Secondary|Duration of Stable Disease (SD)|Duration of SD was calculated as the time from the first date of receiving study drug until the date of documented PD or the last observation if the subject did not progress. Subjects without disease progression at the time of analysis were censored at the last date of tumor evaluation.|From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks|Subjects from ITT population who achieved objective response of CR or PR were excluded from this evaluation.||Days||95% Confidence Interval|Median
764474|NCT00664326|Other Pre-specified|Duration of Response (Update)|Duration of response was defined as the time from the first documented objective response of PR or CR, whichever was earlier, to disease progression or death (if death occurred before progression was documented). Duration of response for subjects who had not progressed or died at the time of analysis were censored at the date of their last tumor assessment.|From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeks|Only subjects from ITT population with a response of CR or PR were included in this evaluation.||Days||95% Confidence Interval|Median
764475|NCT00664326|Secondary|Duration of Response|Duration of response was defined as the time from the first documented objective response of PR or CR, whichever was earlier, to disease progression or death (if death occurred before progression was documented). Duration of response for subjects who had not progressed or died at the time of analysis were censored at the date of their last tumor assessment.|From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks|Only subjects from ITT population with a response of CR or PR were included in this evaluation.||Days||95% Confidence Interval|Median
764476|NCT00664326|Other Pre-specified|Time to Progression (Update)|TTP was calculated as time from first date of receiving study drug until date of first documented disease progression (PD) (radiological or clinical, whichever was earlier). The actual date of tumor assessments (i.e., date on which radiological procedure was performed, rather than the scheduled date) was used for this calculation to determine both the event date and censoring date. Patients without PD at time of analysis were censored at last date of tumor evaluation.|From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeks|intention-to-treat (ITT)||Days||95% Confidence Interval|Median
764477|NCT00664326|Secondary|Time to Progression (TTP)|TTP was calculated as time from first date of receiving study drug until date of first documented disease progression (PD) (radiological or clinical, whichever was earlier). The actual date of tumor assessments (i.e., date on which radiological procedure was performed, rather than the scheduled date) was used for this calculation to determine both the event date and censoring date. Patients without PD at time of analysis were censored at last date of tumor evaluation.|From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks|intention-to-treat (ITT)||Days||95% Confidence Interval|Median
764478|NCT00664326|Other Pre-specified|Progression-free Survival (Update)|PFS was calculated as time from first date of receiving study drug until date of first observed disease progression (PD) (radiological or clinical, whichever was earlier) or death due to any cause, if death occurred before PD was documented. The actual date of tumor assessments (i.e., date on which radiological procedure was performed, rather than scheduled date) was used for this calculation to determine both the event date and censoring date. Patients without PD or death at time of analysis were censored at last date of tumor evaluation.|From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeks|intention-to-treat (ITT)||Days||95% Confidence Interval|Median
764479|NCT00664326|Secondary|Progression-free Survival (PFS)|PFS was calculated as time from first date of receiving study drug until date of first observed disease progression (PD) (radiological or clinical, whichever was earlier) or death due to any cause, if death occurred before PD was documented. The actual date of tumor assessments (i.e., date on which radiological procedure was performed, rather than scheduled date) was used for this calculation to determine both the event date and censoring date. Patients without PD or death at time of analysis were censored at last date of tumor evaluation.|From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks|intention-to-treat (ITT)||Days||95% Confidence Interval|Median
764480|NCT00664326|Other Pre-specified|Overall Survival (Update)|Overall survival (OS) was calculated as the time from the first date of receiving study medication to death, due to any cause. Participants alive at the time of analysis were censored at their last date of follow-up.|From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011).|intention-to-treat (ITT)||Days||95% Confidence Interval|Median
764481|NCT00664326|Secondary|Overall Survival|Overall survival (OS) was calculated as the time from the first date of receiving study medication to death, due to any cause. Participants alive at the time of analysis were censored at their last date of follow-up.|From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009).|intention-to-treat (ITT)||Days||95% Confidence Interval|Median
764482|NCT00664326|Other Pre-specified|Disease Control (Update)|Disease control was defined as the percentage of participants who had a best response rating of CR (tumor disappears), PR (sum of lesion sizes decreased at least 30% from baseline), or SD (steady state of disease) that was maintained for at least 28 days from the first demonstration of that rating.|From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeks|Evaluable for response (Primary analysis population)||Percentage of participants|||Number
764483|NCT00664326|Secondary|Disease Control|Disease control was defined as the percentage of participants who had a best response rating of CR (tumor disappears), PR (sum of lesion sizes decreased at least 30% from baseline), or SD (steady state of disease) that was maintained for at least 28 days from the first demonstration of that rating.|From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks|Evaluable for response (Primary analysis population)||Percentage of participants|||Number
764484|NCT00664326|Other Pre-specified|Tumor Response (Update)|Tumor response of a participant was defined as the best tumor response (confirmed Complete Response [CR, tumor disappears], Partial Response [PR, sum of lesion sizes decreased at least 30% from baseline], Stable Disease [SD, steady state of disease], or Progressive Disease [PD, sum of lesion sizes increased at least 20% from smallest sum on study or new lesions]) observed during trial period assessed according to the RECIST committee.|From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeks|Evaluable for response (Primary analysis population)||Percentage of participants|||Number
764485|NCT00664326|Primary|Tumor Response|Tumor response of a participant was defined as the best tumor response (confirmed Complete Response [CR, tumor disappears], Partial Response [PR, sum of lesion sizes decreased at least 30% from baseline], Stable Disease [SD, steady state of disease], or Progressive Disease [PD, sum of lesion sizes increased at least 20% from smallest sum on study or new lesions]) observed during trial period assessed according to the RECIST committee.|From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks|Evaluable for response (Primary analysis population)||Percentage of participants|||Number
764486|NCT00664326|Other Pre-specified|Objective Tumor Response (Update)|Objective tumor response of a participant was defined as the best tumor response (confirmed Complete Response [CR, tumor disappears] or Partial Response [PR, sum of lesion sizes decreased at least 30% from baseline]) observed during trial period assessed according to the RECIST committee.|From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeks|Evaluable for response (Primary analysis population)||Percentage of participants|||Number
764487|NCT00664326|Primary|Objective Tumor Response|Objective tumor response of a participant was defined as the best tumor response (confirmed Complete Response [CR, tumor disappears] or Partial Response [PR, sum of lesion sizes decreased at least 30% from baseline]) observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) committee.|From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks|Evaluable for response (Primary analysis population)||Percentage of participants|||Number
764488|NCT00664430|Secondary|Number of Participants With Adverse Events|The occurrence of adverse events was considered a secondary endpoint in this study. For details on adverse events that occurred prior to study termination, refer to the safety section below.|Up to 1 year|||Participants|||Number
764489|NCT00664430|Secondary|Changes in Bone Remodeling Markers Over Time|Deoxypyridinoline and bone-specific alkaline phosphatase levels were to be measured every 3 months and changes over time analyzed using descriptive statistics.|Every 3 months|No efficacy analysis was performed in this study. At the time the study was stopped, 3 participants were receiving paricalcitol, but none of them had reached the time point for the secondary analysis.||ng/mL||Standard Deviation|Mean
764490|NCT00664430|Primary|Proportion of Participants With a 50% Reduction in Parathyroid Hormone (PTH) Levels Relative to Visit 4 Values|This outcome was measured at Visit 15, which could occur at different timepoints from study start, depending on the duration of each study period for each participant, relative to values on Visit 4. For participants who did not perform visit 4, the reduction of the PTH levels were to be assessed relative to visit 5 values.|Up to Week 24|No efficacy analysis was performed in this study. At the time the study was stopped, 3 participants were receiving paricalcitol, but none of them had reached the time point for the primary analysis.||Proportion of participants|||Number
764986|NCT00673153|Secondary|Relapse-free Survival (Good- and Poor-risk Group)||At relapse|Poor-risk Group: patients aged ≥70 years and performance status 2-3; Good-risk Group: aged 60-69 years with performance status 0-3, or aged ≥70 years and performance status 0-1||Participants|||Count of Participants
764491|NCT00664521|Secondary|Median Percentage Change From Baseline in Levels of Total, Mature and Memory B Cells|Flow cytometric analysis of lymphocyte populations using four-color fluorescence-activated cell sorting was performed for the analysis of total, mature and memory B cell levels.|Baseline, Week 3, 7, 12, 16, 26 and 32|Safety population included all participants who received at least one dose of atacicept or placebo. Here 'n' signifies those participants who were evaluable for the specified category.||percent change||Inter-Quartile Range|Median
764492|NCT00664521|Secondary|Change From Baseline in Disease Activity Score in 28 Joints (DAS28) Based on CRP (DAS28-CRP) at Week 32|DAS28-CRP incorporates non-graded joint counts for tenderness and swelling based on a total of 28 joints, CRP as a marker of inflammation, and a general health assessment using a 100 mm visual analog scale (the participant's global assessment of disease activity). DAS28 score ranges between 0 and 10 representing current disease activity. A value above 5.1 represents high disease activity, a value below 3.2 represents low disease activity, and a value below 2.6 represents remission.|Baseline, Week 32|ITT population included all randomized participants. Here 'n' signifies those participants who were evaluable for the specified category.||Units on a scale||Standard Deviation|Mean
764493|NCT00664521|Secondary|Percentage of Participants Achieving American College of Rheumatology 20 Response Based on C-reactive Protein (ACR20-CRP), ACR50-CRP and ACR70-CRP at Week 32|ACR20-CRP response: greater than or equal to (>=) 20 percent (%) improvement in both tender joint counts (based on a total of 68 joints) and swollen joint counts (based on a total of 66 joints) together with >=20% improvement in at least 3 of the following: 1) participant's assessment of pain; 2) participant's global assessment of disease activity; 3) physician's global assessment of disease activity; 4) participant's assessment of physical function; and 5) acute-phase marker (CRP). ACR50-CRP and ACR70-CRP response are defined as >=50% and >=70% improvement in both tender joint counts (based on a total of 68 joints) and swollen joint counts (based on a total of 66 joints) respectively together with >=50% and >=70% improvement in at least 3 of the following respectively: 1) participant's assessment of pain; 2) participant's global assessment of disease activity; 3) physician's global assessment of disease activity; 4) participant's assessment of physical function; and 5) CRP.|Week 32|ITT population included all randomized participants.||percentage of participants|||Number
764494|NCT00664521|Primary|Percent Change From Baseline in Anti-pneumococcus Titer at Week 32|Percent change from baseline was calculated as ([Week 32 value minus baseline value] multiplied by 100) divided by baseline value.|Baseline, Week 32|"Safety population included all participants who received at least one dose of atacicept or placebo. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure."||percent change||Inter-Quartile Range|Median
764495|NCT00664521|Primary|Percent Change From Baseline in Anti-tetanus and Anti-diphteria Immunization Titer at Week 32|Percent change from baseline was calculated as ([Week 32 value minus baseline value] multiplied by 100) divided by baseline value.|Baseline, Week 32|"Safety population included all participants who received at least one dose of atacicept or placebo. Here. N (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure."||percent change||Inter-Quartile Range|Median
764496|NCT00664521|Primary|Percent Change From Baseline in Vital Signs and Routine Safety Lab Parameters at Week 32|Vital signs assessed included blood pressure (systolic and diastolic), pulse and body temperature. Routine safety lab parameters evaluated included red blood cell (RBC), hemoglobin, hematocrit, platelets, mean cellular hemoglobin (MCH), MCH concentration, MCH volume, white blood cell (WBC), lymphocytes, monocytes, eosinophils, basophils, neutrophils, gamma glutamyl transferase (GGT), alanine aminotransferase (ALT), albumin, alkaline phosphatase (AP), aspartate aminotransferase (AST), bilirubin, calcium, creatinine, glucose, potassium, total protein, sodium, uric acid, and blood urea nitrogen. Percent change from baseline was calculated as ([Week 32 value minus baseline value] multiplied by 100) divided by baseline value.|Baseline, Week 32|"Safety population included all participants who received at least one dose of atacicept or placebo. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable for the specified category."||Percent change||Standard Deviation|Mean
764497|NCT00664521|Primary|Percentage of Participants With Immunoglobulin G (IgG) Level Less Than 3 Gram Per Liter (g/L)||Week 64|Safety population included all participants who received at least one dose of atacicept or placebo. Here. “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.||percentage of participants|||Number
764498|NCT00664521|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. An SAE was defined as an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.|Baseline up to Week 64|Safety population included all participants who received at least one dose of atacicept or placebo.||Participants|||Number
764499|NCT00664534|Secondary|Number of Participants With Adverse Events|"A summary of serious adverse events (SAEs) and all other non-serious treatment-emergent adverse events (TEAE) is located in the Reported Adverse Event Module.
TEAEs are defined as events that are newly reported after randomization or reported to worsen in severity from baseline."|Baseline to 48 weeks|Safety Set Population: All participants who received at least one dose of study drug during the treatment period.||participants|||Number
764500|NCT00664534|Secondary|Rate Per 30 Days of All Self-reported Hypoglycemic Episodes|The hypoglycemia rate between two visits will be calculated as the total number of episodes between the two visits divided by the number of days between the visits, and then multiplied by 30 days (rate per patient per 30 days).|Baseline to 48 weeks|Safety Set Population: All participants who received at least one dose of study drug during the treatment period and had measurement at baseline and endpoint.||episodes per 30 days||Standard Deviation|Mean
764515|NCT00664560|Secondary|Change in Patient Global Assessment (PGA) Subscore From Baseline|PGA questionnaire. The patient global assessment (PGA) question asks about how the subject is doing considering his/her arthritis and is measured by a visual analog scale (VAS); 0 mm (very poor) 100 mm (excellent). The outcome measures a change from baseline PGA in mm.|Week 6|Intent to treat||mm||Standard Deviation|Mean
764987|NCT00673153|Primary|Number of Participants Alive at Day 30 (Poor-risk Group)||At day 30|Poor-risk Group: patients aged ≥70 years and performance status 2-3||Participants|||Count of Participants
764501|NCT00664534|Secondary|Incidence of All Self-reported Hypoglycemic Episodes|Percentage of participants with self-reported hypoglycemic episodes at any time during the study. A hypoglycemic episode is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia, or has a blood glucose level of ≤70 mg/dL (3.9 mmol/L) (Roche plasma glucose) or ≤75 mg/dL (4.2 mmol/L) (IFCC Plasma Values), even if it was not associated with signs, symptoms, or treatment consistent with current guidelines (ADA 2005).|Baseline to 48 weeks|Safety Set Population: All participants who received at least one dose of study drug during the treatment period and had measurement at baseline and endpoint.||percentage of participants|||Number
764502|NCT00664534|Secondary|Body Weight Change From Baseline to Endpoint||baseline, 48 weeks|Safety Set Population: All participants who received at least one dose of study drug during the treatment period and had measurement at baseline and endpoint.||kilograms (kg)||95% Confidence Interval|Least Squares Mean
764503|NCT00664534|Secondary|Mean Daily Total, Basal and Prandial Insulin Dose||16 weeks, 32 weeks and 48 weeks|Full Analysis Set: All participants who enrolled in this study, completed Screening, were randomized to one of the study treatments, and had at least one post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.||International Units per day (IU/day)||Standard Deviation|Mean
764504|NCT00664534|Secondary|Mean Postprandial Blood Glucose Values|Mean postprandial blood glucose values were assessed using GlycoMark, which is an FDA-approved blood test measuring levels of 1,5 anhydroglucitol (1,5 AG) in serum or plasma. When 1,5 AG values decrease, serum glucose levels increase.|Baseline, 16 weeks, 32 weeks and 48 weeks|Full Analysis Set: All participants who enrolled in this study, completed Screening, were randomized to one of the study treatments, and had at least one post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.||microgram per milliliter (µg/mL)||Standard Deviation|Mean
764505|NCT00664534|Secondary|7-point Self-monitored Blood Glucose Profiles||16 weeks, 32 weeks and 48 weeks|Full Analysis Set: All participants who enrolled in this study, completed Screening, were randomized to one of the study treatments, and had at least one post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.||millimoles per Liter (mmol/L)||Standard Error|Least Squares Mean
764506|NCT00664534|Secondary|Percentage of Patients Achieving HbA1c Less Than or Equal to 6.5% and Less Than or Equal to 7% Over Time||16 weeks, 32 weeks and 48 weeks|Full Analysis Set: All participants who enrolled in this study, completed Screening, were randomized to one of the study treatments, and had at least one post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.||percentage of participants|||Number
764507|NCT00664534|Secondary|HbA1c Over Time|Least Squares Mean (LSMean) values were adjusted based on a mixed effect linear regression model with a participant specific random effect: HbA1c = Treatment + Country + HbA1c baseline value + Ramadan holiday between Visit 10 (Week 36) and Visit 12 (Week 48) (yes/no) + visit + visit*treatment in Full Analysis Set (FAS) Population.|16 weeks, 32 weeks, and 48 weeks|Full Analysis Set: All participants who enrolled in this study, completed Screening, were randomized to one of the study treatments, and had at least one post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.||percent glycosylated hemoglobin||95% Confidence Interval|Least Squares Mean
764508|NCT00664534|Secondary|Percentage of Participants Using Each Possible Final Insulin Regimen|"Insulin Regimens:
Lispro: Mid-Mix (MM) before noon; Low-Mix (LM) before evening (PM); MM before noon+LM before PM; LM before morning (AM)+MM before noon + LM before PM; MM before AM +MM before noon+LM before PM Glargine: Glargine once a day (QD); Glargine QD + 1 Lispro (noon or PM); Glargine QD + 2 Lispro (noon and PM); Glargine QD + 3 Lispro."|48 weeks|Full Analysis Set: All participants who enrolled in this study, completed Screening, were randomized to one of the study treatments, and had a measurement for the dependent variable at the time point, according to intent-to-treat (ITT) principles.||percentage of participants|||Number
764509|NCT00664534|Primary|Baseline Adjusted Glycosylated Hemoglobin (HbA1c) at Endpoint|Least Squares Mean (LSMean) values were adjusted based on a fixed effect linear regression model: HbA1c = Treatment + Country + HbA1c baseline value + Ramadan holiday between Visit 10 (Week 36) and Visit 12 (Week 48) (yes/no) in per-protocol (PP) population.|48 weeks|"PP Population=All participants who were randomized and met following criteria during study:
no violations of Inclusion/Exclusion Criteria
no early study discontinuation
compliant with treatment
received no other antihyperglycemic medication than allowed in Protocol, and have not been on systemic glucocorticoids for >14 consecutive days."||percent glycosylated hemoglobin||95% Confidence Interval|Least Squares Mean
764510|NCT00664560|Secondary|The Number of Subjects Who Discontinued From the Study Due to Any Pre-specified Non-steroidal Antiinflammatory Drug-associated Upper Gastrointestinal Adverse Event|The number of subjects who discontinued from the study due to any pre-specified non-steroidal antiinflammatory drug (NSAID)-associated upper gastrointestinal (UGI) adverse event (as classified by MedDRA). Pre-specified NSAID-associated UGI symptoms include adverse events such as dyspepsia, abdominal pain or discomfort, nausea, vomiting.|daily during 12 weeks|Safety population||participants|||Number
764511|NCT00664560|Secondary|Number of Participants Reporting Pre-specified Non-steroidal Antiinflammatory Drug-associated Upper Gastrointestinal (UGI) Symptoms|Number of participants reporting pre-specified non-steroidal antiinflammatory drug-associated (NSAID) upper gastrointestinal (UGI) symptoms. Pre-specified NSAID-associated UGI symptoms include adverse events such as dyspepsia, abdominal pain or discomfort, nausea, vomiting.|daily during 12 weeks|Safety population||participants|||Number
764512|NCT00664560|Secondary|Percent of Days With no Heartburn (Heartburn Resolution)|During 12 weeks, daily heartburn question with ratings none, mild, moderate, or severe. Percent of days with Heartburn resolution (heartburn is none).|12 weeks|Intent to treat||percent days||Standard Deviation|Mean
764513|NCT00664560|Secondary|Modified Severity of Dyspepsia Assessment (mSODA)|Change from Baseline in the Modified Severity of Dyspepsia Assessment (mSODA) average daily pain intensity converted total score at Week 12. The mSODA instruments consists of 6 questions about abdominal discomfort during the past 24 hours, with a converted score of 2 through 47. Lower score equals less pain.|Baseline to 12 weeks|||Scores on a scale||Standard Deviation|Mean
764514|NCT00664560|Secondary|Antacid Tablet Use|Tablet pill count|12 weeks|||Tablets per subject||Standard Deviation|Mean
765289|NCT00670007|Secondary|Percent Change in Lung Function as Measured by Ratio of FEV1/FVC (Forced Vital Capacity)||From baseline up to 2 years|ITT population. Subjects may not have been included in all efficacy analyses because of missing efficacy assessments.||Percent change from baseline||Standard Deviation|Mean
764516|NCT00664560|Secondary|Change in Western Ontario and McMaster Universities (WOMAC) Function Questionnaire Subscore From Baseline|"WOMAC function questionnaire (VAS). The 17 questions about function all use visual analog scale (VAS) of 100 mm; 0 mm being no pain and 100 mm being extreme pain. The outcome measures a change in WOMAC pain from baseline (in mm).
The Western Ontario and McMaster Universities (WOMAC) is a self-administered, patient-reported health status questionnaire that is designed to capture elements of pain, stiffness and physical disability in patients with OA of the knee and/or hip joints. The index consists of 24 questions (5 questions about pain, 2 on stiffness and 17 about physical function)."|Week 6|Intent to treat||mm||Standard Deviation|Mean
764517|NCT00664560|Secondary|Change in Western Ontario and McMaster Universities (WOMAC) Pain Questionnaire Subscore From Baseline|"Western Ontario and McMaster Universities (WOMAC) pain questionnaire has 5 questions on pain all use visual analog scale (VAS) of 100 mm, with 0 mm being no pain and 100 mm being extreme pain. The outcome measures a change in WOMAC pain at 6 weeks from baseline (in mm). WOMAC is a self-administered, patient-reported health status questionnaire designed to capture elements of pain, stiffness and physical disability in patients with OA of the knee and/or hip joints. It consists of 24 questions (5 questions about pain, 2 on stiffness and 17 about physical function)."|Week 6|Intent to treat||mm||Standard Deviation|Mean
764518|NCT00664560|Secondary|American Pain Society Patient Outcome Questionnaire (APS-POQ)Total Interference Caused by Pain.|Mean change from Baseline scores calculated for each subject through Day 7. Scale 0 through 70, where 0=no pain interference and 70=complete interference.|Baseline and Day 7|Intent to Treat||Units on a scale||Standard Deviation|Mean
764519|NCT00664560|Primary|Change in Patient Global Assessment (PGA) Subscore From Baseline|PGA questionnaire. The patient global assessment (PGA) question asks about how the subject is doing considering his/her arthritis and is measured by a visual analog scale (VAS); 0 mm (very poor) 100 mm (excellent). The outcome measures a change from baseline PGA in mm.|12 weeks|Analysis Population: Baseline + took >= 1 dose + >= 1 post-baseline PGA efficacy evaluation (intent-to-treat population). Used Last Observation Carried Forward||mm||Standard Deviation|Mean
764520|NCT00664560|Primary|Change in Western Ontario and McMaster Universities (WOMAC) Function Questionnaire Subscore From Baseline|"WOMAC function questionnaire (VAS). The 17 questions about function all use visual analog scale (VAS) of 100 mm; 0 mm being no pain and 100 mm being extreme pain. The outcome measures a change in WOMAC pain from baseline (in mm).
The Western Ontario and McMaster Universities (WOMAC) is a self-administered, patient-reported health status questionnaire that is designed to capture elements of pain, stiffness and physical disability in patients with OA of the knee and/or hip joints. The index consists of 24 questions (5 questions about pain, 2 on stiffness and 17 about physical function)."|12 weeks|Analysis Population: Baseline + took >= 1 dose + >= 1 post-baseline WOMAC efficacy evaluation (intent-to-treat population). Used Last Observation Carried Forward||mm||Standard Deviation|Mean
764521|NCT00664560|Primary|Change in Western Ontario and McMaster Universities (WOMAC) Pain Questionnaire Subscore From Baseline|"Western Ontario and McMaster Universities (WOMAC) pain questionnaire has 5 questions on pain all use visual analog scale (VAS) of 100 mm, with 0 mm being no pain and 100 mm being extreme pain. The outcome measures a change in WOMAC pain at 12 weeks from baseline (in mm). WOMAC is a self-administered, patient-reported health status questionnaire designed to capture elements of pain, stiffness and physical disability in patients with OA of the knee and/or hip joints. It consists of 24 questions (5 questions about pain, 2 on stiffness and 17 about physical function)."|Baseline and 12 weeks|Analysis Population: Baseline + took >= 1 dose + >= 1 post-baseline WOMAC efficacy evaluation (intent-to-treat population). Used Last Observation Carried Forward||mm||Standard Deviation|Mean
764522|NCT00664742|Secondary|Percentage of Participants Achieving Total Cholesterol (TC), Low Density Lipoprotein-Cholesterol (LDL-C), High Density Lipoprotein-Cholesterol (HDL-C) and Triglycerides (TG) Predefined Target Lipid Levels|The percentage of participants who achieved the following predefined lipid target levels at Baseline and at 6 months: TC <200 mg/dL, LDL-C <100 mg/dL, HDL-C >=60 mg/dL and TG < 150 mg/dL.|Baseline, 6 weeks|This analysis was done on the safety population which consists of all participants who received at least one dose of study medication.||Percentage of Participants|||Number
764523|NCT00664742|Primary|Change in Total Cholesterol (TC), High Density Lipoprotein-Cholesterol (HDL-C), Low Density Lipoprotein-Cholesterol (LDL-C) and Triglycerides (TG) Levels From Baseline to Week-6|Mean Absolute change in lipid profile parameters (TC, HDL-C, LDL-C and TG) calculated by the mean level for each parameter at week 6 minus the mean level at baseline.|Baseline,6 weeks|The analysis was done on the Per Protocol Population which consists of all participants who did not violate inclusion/ exclusion criteria, completed the treatment study phase or withdrew from the study due to progression, death, or toxicity (AE related to study drug) and had at least one key response evaluation.||mg/dL||95% Confidence Interval|Mean
764524|NCT00665002|Secondary|Participants Whose Samples Demonstrated Immunological Response After Vaccination|"Immune Response: Immune reactivity was measured for all participants. Immune response was measured by T cell proliferative response and DTH against WT-1 peptides. In patients with adequate samples, T cell gamma interferon release as measured by ELISPOT and/or multiparameter intracellular staining by flow cytometry were performed as well.
ELISPOT Assay: CD4+ immune response, CD4+ and CD8+ response. The samples of participants' blood obtained at baseline and week 12 were tested for CD4 T cell proliferation, CD4 and CD8 T cell interferon release.
Tetramer Analysis of WT1-specific Immune responses: subtle WT1 T cell expansion, positive by ELISPOT and T cell expansion.
Delayed-type Hypersensitivity (DTH): measurable DTH response without overlap with ELISPOT or tetramer responders).
Overall: any form of immune response."|12 weeks|All participants||participants|||Number
764525|NCT00665002|Primary|Number of Participants With Adverse Events (AEs)|Toxicities were tabulated according to the NCI Common Toxicity (version 3.0) by grade and category. If more than one patient developed ≥ grade 3 non-hematologic toxicity or grade 4 hematologic toxicity, the study accrual was to be suspended immediately for a careful toxicity data evaluation. Depending upon the findings of such safety/toxicity data assessment and consultation with the supporting pharmaceutical company, the principal investigator of this trial would have the option of terminating this trial permanently, amending the study protocol, or resuming the patient accrual.|12 weeks to 6 months|All participants||participants|||Number
764614|NCT00665925|Secondary|Alkaline Phosphatase >1.5 x Upper Limit of Normal (ULN) and >1.5 Times Baseline|The number of participants with alkaline phosphatase (a test of liver function) values greater than 1.5 times the ULN and greater than 1.5 times baseline|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.||Participants|||Number
764526|NCT00665132|Secondary|Mean Change in Pain Achieved by Participants Who Reported Pain Change From Baseline to Day 5|Using Brief Pain Inventory questions 14 and 15, those 9 subjects who had pain change from Baseline to Day 5 were analyzed to determine change in pain for the overall group. In the BPI, an 11-point NRS is used to rate pain intensity, with a 0 for ‘‘no pain’’ and a 10 for ‘‘pain as bad as you can imagine.’’ At Baseline, patients circled the number that best described how much baseline pain they had 'on average' (BPI #14). During the study, patients circled the one number that best described how much pain they had at the time 'right now' (BPI #15).|Day 5 after final stimulation|Nine subjects who reported change after 5 days of StimRouter System use are analyzed to determine mean change in pain from Baseline to Day 5 of Stimulation for the overall group.||units on a scale||Standard Deviation|Mean
764527|NCT00665132|Secondary|Percent of Participants Reporting Pain Change From Baseline to Day 5|Brief Pain Inventory (BPI) questions 14 and 15 were used to measure pain change after 5 days use of StimRouter System. In the BPI, an 11-point numerical rating scale (NRS) is used to rate pain intensity, where zero (0) indicates ‘‘no pain’’ and 10 indicates ‘‘pain as bad as you can imagine.’’ At enrollment, participants circled the number that best described how much baseline pain they had 'on average' (BPI #14). After enrollment and during the study, patients circled the one number that best described how much pain they had at that time 'right now' (BPI #15). The percent of participants with change from Baseline to Day 5 was calculated.|Day 5|All ten participants were analyzed.||percentage of patients|||Number
764528|NCT00665132|Secondary|Patent Satisfaction|Numerical rating scale (NRS) of 0-10 where 0 = not satisfied and 10 = very satisfied|Day 5 after final stimulation|All ten subjects responses were analyzed.||units on a scale||Standard Deviation|Mean
764529|NCT00665132|Primary|Implant Success|Success of device implantation was defined as uncomplicated minimally-invasive implantation of the StimRouter Lead near the targeted peripheral median nerve, resulting in production of desired paresthesias in the sensory distribution of the median nerve when active peripheral nerve stimulation was applied. This outcome parameter was intended to serve as an indication that the lead and electrode stimulating positions could be correctly placed while still maintaining the minimal invasiveness of the procedure. Fluoroscopic imaging was used to document positioning of the StimRouter Lead and, by applying stimulation from a commercially available Dakmed External Pulse Generator (EPG) to the StimRouter Lead, desired paresthesia response was confirmed.|at device implantation procedure|||participants with successful implant|||Number
764530|NCT00665353|Secondary|Absolute Change From Entry to Week 24 of Step 1 in Fasting Total Cholesterol and Triglycerides.||From Entry to Week 24 of Step 1|Subjects with both Entry and Week 24 fasting lipid results.||mg/dL||Inter-Quartile Range|Median
764531|NCT00665353|Secondary|Absolute Change From Entry to Week 24 of Step 1 in Homeostasis Model of Assessment - Insulin Resistance (HOMA-IR)||From Entry to Week 24 of Step 1|Subjects with both Entry and Week 24 HOMA-IR results.||mg/dL x uIU/mL / 405||Inter-Quartile Range|Median
764532|NCT00665353|Secondary|Absolute Change From Entry to Week 24 of Step 1 in AST and ALT.||From Entry to Week 24 of Step 1|Subjects with both Entry and Week 24 LFT results.||x ULN||Inter-Quartile Range|Median
764533|NCT00665353|Secondary|The Proportion of All Subjects With HCV Viral Load < 60 IU/mL at Week 72of Step 2.||Week 72 of Step 2|All enrolled subjects.||proportion of participants||90% Confidence Interval|Number
764534|NCT00665353|Secondary|Safety and Tolerability|Summary of the number of subjects with at least one grade 3 or higher sign/symptom or laboratory abnormality.|Step 2 (Up to 72 weeks)|All subject enrolled in Step 2.||participants|||Number
764535|NCT00665353|Secondary|Safety and Tolerability|Summary of the number of subjects with at least one grade 3 or higher sign/symptom or laboratory abnormality.|Step 1 (Up to 24 to 28 weeks)|All enrolled subjects.||participants|||Number
764536|NCT00665353|Primary|The Proportion of All Subjects With HCV Viral Load < 60 IU/mL at Week 24 of Step 2.||Week 24 of Step 2|All enrolled subjects.||proportion of participants||90% Confidence Interval|Number
764537|NCT00665366|Secondary|Change From Baseline to Week 12 in Body Mass Index (BMI) (LOCF Data Set)|BMI=Weight in kilograms /(Height in meters^2). LOCF=last observation carried forward.|Baseline to Week 12|All randomized participants who received at least 1 dose of study medication. n=number of evaluable participants.||kg/m^2||Full Range|Median
764538|NCT00665366|Secondary|Percentage of Participants With Relevant Weight Gain or Weight Loss From Baseline at Week 12 (LOCF Data Set)|Relevant weight gain=7% or greater increase in weight; relevant weight loss=7% or greater decrease in weight. LOCF=last observation carried forward.|Baseline to Weeks 3, 6, 9, and12|All randomized participants who received at least 1 dose of study medication. n=number of evaluable participants.||Percentage of participants|||Number
764539|NCT00665366|Secondary|Change From Baseline in Participant Weight (OC Data Set and Week 12 LOCF Data Set)|Adjusted mean change.OC=observed cases; LOCF=last observation carried forward.|Baseline to Weeks 3, 6, 9, and 12|All randomized participants who received at least 1 dose of study medication. n=number of evaluable participants.||Kilograms||Standard Error|Mean
764540|NCT00665366|Secondary|Participant Scores on Patient Global Impression Improvement (PGI-I) Scale (OC Data Set)|Adjusted Mean Scores. The PGI-I is a self-administered 7-point scale, with scores ranging from 1 (very much improved) to 7 (very much worse), that assesses the improvement or worsening of a patient's illness relative to baseline at the beginning of the intervention. Scores: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; or 7=very much worse. OC=observed cases.|Baseline to Weeks 3, 6, 9, and 12|All randomized participants who received at least 1 dose of study medication and who had at least 1 outcomes research evaluation after the start of study drug. n=number of evaluable participants.||Units on a scale||Standard Error|Mean
764541|NCT00665366|Secondary|Change From Baseline in Total Score on the Longitudinal Interval Follow-up Evaluation-Rating Impaired Functioning Tool (LIFE-RIFT)(OC Data Set and Week 12 LOCF Data Set)|Adjusted mean change. The LIFE-RIFT total score ranges from 4 to 20 and is the sum of scores of 4 items: work, interpersonal relations, satisfaction, and recreation. A negative change score signifies improvement. OC=observed cases; LOCF=last observation carried forward.|Baseline to Weeks 6 and 12|All randomized participants who received at least 1 dose of study medication and had at least 1 outcome research evaluation after the start of study drug. n=number of evaluable participants.||Units on a scale||Standard Error|Mean
764615|NCT00665925|Secondary|Aspartate Aminotransferase (AST) >10 x Upper Limit of Normal (ULN)|The number of participants with AST (a test of liver function) values greater than 10 times the ULN|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.||Participants|||Number
764542|NCT00665366|Secondary|Percentage of Participants Showing Remission in the Young Mania Rating Scale (YMRS) Score From Baseline (LOCF Data Set)|Remission is defined as a YMRS total score of 12 or less. The YMRS is clinician-administered and consists of 11 multiple choice items. It is used to assess a patient’s manic symptoms and clinical condition over the previous 48 hours. Total scores range from 0 to 60, with 12 or greater signifying hypomania or mania. Each item is given a severity rating ranging from 0 to 8 or 0 to 4. Items for the scale are based on the core symptoms of mania: elevated mood, increased motor activity, sexual interest, sleep, irritability, speech (rate and amount), language-thought disorder, disruptive-aggressive behavior, appearance, and insight. Scores for each item reflect the severity of that symptom in the patient. The test is administered during a clinical interview typically lasting 15-30 minutes. LOCF=last observation carried forward.|Baseline to Weeks 3,6, 9, and 12|All randomized participants who received at least 1 dose of study medication and who had at least 1 efficacy evaluation after the start of study drug. n=number of evaluable participants.||Percentage of participants|||Number
764543|NCT00665366|Secondary|Percentage of Participants Showing A Response From Baseline on the Young Mania Rating Scale (YMRS)(OC Data Set)|Response on the YMRS is defined as a 50% or greater improvement from baseline in YMRS total score. The YMRS is clinician-administered and consists of 11 multiple choice items. It is used to assess a patient’s manic symptoms and clinical condition over the previous 48 hours. Total scores range from 0 to 60, with 12 or greater signifying hypomania or mania. Each item is given a severity rating ranging from 0 to 8 or 0 to 4. Items for the scale are based on the core symptoms of mania: elevated mood, increased motor activity, sexual interest, sleep, irritability, speech (rate and amount), language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight. Scores for each item reflect the severity of that symptom in the patient. The test is administered during a clinical interview typically lasting 15-30 minutes. OC=observed cases.|Baseline to Weeks 3, 6, 9, and 12|All randomized participants who received at least 1 dose of study medication and who had at least 1 efficacy evaluation after the start of study drug. n=number of evaluable participants.||Percentage of participants|||Number
764544|NCT00665366|Secondary|Change From Baseline in Total and Subscale Scores on the Functional Assessment Short Test (FAST)(LOCF Data Set)|The FAST is an interview-administered instrument used to assess the main functioning problems that patients with bipolar disorder experience. Participants are rated at Baseline, Week 3, Week 6, Week 9, and Week 12/End of Study Visit. The FAST consists of 24 items that assess impairment or disability in 6 specific areas of functioning, categorized as the subscales: autonomy, occupational functioning, cognitive functioning, financial issues, interpersonal (IP) relationships, and leisure time. All items are rated using a 4-point scale, 0=no difficulty, 1=mild difficulty, 2=moderate difficulty, and 3=severe difficulty. The global score is the sum of the scores of all items and ranges from 0 (0*24)to 96 (4*24). The higher the global score, the higher the level of impairment. function=functioning. LOCF=last observation carried forward.|Baseline to Weeks 3, 6, 9, and 12|All randomized participants who received at least 1 dose of study medication and who had at least 1 outcomes research evaluation after the start of study drug. n=number of evaluable participants.||Units on a scale||Standard Error|Mean
764545|NCT00665366|Secondary|Change From Baseline in Score on Clinical Global Impression-Bipolar Version (CGI-BP) Severity of Illness (Overall) Scale at Week 12 (LOCF Data Set)|Adjusted mean change. The CGI-BP is scale used to assess a clinician's impression of a patient's illness. Each patient is rated at baseline and at subsequent visits on items related to severity of depression, mania, and overall bipolar illness. The CGI-BP is a 7-point scale, with scores ranging from 1=normal/not ill to 7=very severely ill. Higher total score indicates greater severity of illness. LOCF=last observation carried forward.|Baseline to Week 12|All randomized participants who received at least 1 dose of study medication and who had at least 1 efficacy evaluation after the start of study drug. n=number of evaluable participants.||Units on a scale||Standard Error|Mean
764546|NCT00665366|Secondary|Change From Baseline in Score on Clinical Global Impression-Bipolar Version (CGI-BP) Severity of Illness (Depression) Scale (LOCF Data Set)|Adjusted mean change. The CGI-BP is a scale used to assess a clinician's impression of a patient's illness. Each patient is rated at baseline and at subsequent visits on items related to severity of depression, mania, and overall bipolar illness. The CGI-BP is a 7-point scale, with scores ranging from 1=normal/not ill to 7=very severely ill. Higher total score indicates greater severity of illness. LOCF=last observation carried forward.|Baseline to Weeks 3, 6, 9, and 12|All randomized participants who received at least 1 dose of study medication and who had at least 1 efficacy evaluation after the start of study drug. n=number of evaluable participants.||Units on a scale||Standard Error|Mean
764547|NCT00665366|Secondary|Change From Baseline in Score on Clinical Global Impression-Bipolar Version (CGI-BP) Severity of Illness (Mania) Scale (LOCF Data Set)|Adjusted mean change. The CGI-BP is a scale used to assess a clinician's impression of a patient's illness. Each patient is rated at baseline and at subsequent visits on items related to severity of depression, mania, and overall bipolar illness. The CGI-BP is a 7-point scale, with scores ranging from 1=normal/not ill to 7=very severely ill. Higher total score indicates greater severity of illness. LOCF=last observation carried forward.|Baseline to Weeks 3, 6, 9, and 12|All randomized participants who received at least 1 dose of study medication and who had at least 1 efficacy evaluation after the start of study drug. n=number of evaluable participants.||Units on a scale||Standard Error|Mean
764548|NCT00665366|Primary|Change From Baseline in Total Score on the Young Mania Rating Scale (YMRS) (LOCF Data Set)|The YMRS is a clinician-administered scale, consisting of 11 multiple choice items, and used to assess a patient’s manic symptoms and clinical condition over the previous 48 hours. Total scores range from 0 to 60, with 12 or greater signifying hypomania or mania. Each item is given a severity rating ranging from 0 to 8 or 0 to 4. Items for the scale are based on the core symptoms of mania: elevated mood, increased motor activity, sexual interest, sleep, irritability, speech (rate and amount), language-though disorder, content, disruptive-aggressive behavior, appearance, and insight. Scores for each item reflect the severity of that symptom in the patient. The test is administered during a clinical interview typically lasting 15-30 minutes. LOCF=last observation carried forward.|Baseline to Week 12|All randomized participants who received at least 1 dose of study medication and who had at least 1 efficacy evaluation after the start of study drug.||Units on a scale||Standard Error|Mean
764616|NCT00665925|Secondary|Aspartate Aminotransferase (AST) >5-10 x Upper Limit of Normal (ULN)|The number of participants with AST (a test of liver function) values greater than 5 to 10 times the ULN|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.||Participants|||Number
764549|NCT00665431|Secondary|The Number of Subjects Who Discontinued From the Study Due to Any Pre-specified Non-steroidal Antiinflammatory Drug-associated Upper Gastrointestinal Adverse Event|The number of subjects who discontinued from the study due to any pre-specified non-steroidal antiinflammatory drug (NSAID)-associated upper gastrointestinal (UGI) adverse event (as classified by MedDRA). Pre-specified NSAID-associated UGI symptoms include adverse events such as dyspepsia, abdominal pain or discomfort, nausea, vomiting.|daily during 12 weeks|Safety population||participants|||Number
764550|NCT00665431|Secondary|Number of Participants Reporting Pre-specified Non-steroidal Antiinflammatory Drug-associated Upper Gastrointestinal (UGI) Symptoms|Number of participants reporting pre-specified non-steroidal antiinflammatory drug-associated (NSAID) upper gastrointestinal (UGI) symptoms. Pre-specified NSAID-associated UGI symptoms include adverse events such as dyspepsia, abdominal pain or discomfort, nausea, vomiting.|daily during 12 weeks|Safety population||participants|||Number
764551|NCT00665431|Secondary|Percent of Days With no Heartburn (Heartburn Resolution)|During 12 weeks, daily heartburn question with ratings none, mild, moderate, or severe. Percent of days with Heartburn resolution (heartburn is none).|12 weeks|Intent to treat||percent days||Standard Deviation|Mean
764552|NCT00665431|Secondary|Modified Severity of Dyspepsia Assessment (mSODA)|Change from Baseline in the Modified Severity of Dyspepsia Assessment (mSODA) average daily pain intensity converted total score at Week 12. The mSODA instruments consists of 6 questions about abdominal discomfort during the past 24 hours, with a converted score of 2 through 47. Lower score equals less pain.|12 weeks|intent to treat with last observation carried forward||Scores on a scale||Standard Deviation|Mean
764553|NCT00665431|Secondary|Antacid Tablet Use|Tablet pill count|12 weeks|Intent to treat||Tablets per subject||Standard Deviation|Mean
764554|NCT00665431|Secondary|Change in Patient Global Assessment (PGA) Subscore From Baseline|PGA questionnaire. The patient global assessment (PGA) question asks about how the subject is doing considering his/her arthritis and is measured by a visual analog scale (VAS); 0 mm (very poor) 100 mm (excellent). The outcome measures a change from baseline PGA in mm.|Week 6|Intent to treat||mm||Standard Deviation|Mean
764555|NCT00665431|Secondary|Change in Western Ontario and McMaster Universities (WOMAC) Function Questionnaire Subscore From Baseline|"WOMAC function questionnaire (VAS). The 17 questions about function all use visual analog scale (VAS) of 100 mm; 0 mm being no pain and 100 mm being extreme pain. The outcome measures a change in WOMAC pain from baseline (in mm).
The Western Ontario and McMaster Universities (WOMAC) is a self-administered, patient-reported health status questionnaire that is designed to capture elements of pain, stiffness and physical disability in patients with OA of the knee and/or hip joints. The index consists of 24 questions (5 questions about pain, 2 on stiffness and 17 about physical function)."|Week 6|Intent to treat||mm||Standard Deviation|Mean
764556|NCT00665431|Secondary|Change in Western Ontario and McMaster Universities (WOMAC) Pain Questionnaire Subscore From Baseline|"Western Ontario and McMaster Universities (WOMAC) pain questionnaire has 5 questions on pain all use visual analog scale (VAS) of 100 mm, with 0 mm being no pain and 100 mm being extreme pain. The outcome measures a change in WOMAC pain at 6 weeks from baseline (in mm). WOMAC is a self-administered, patient-reported health status questionnaire designed to capture elements of pain, stiffness and physical disability in patients with OA of the knee and/or hip joints. It consists of 24 questions (5 questions about pain, 2 on stiffness and 17 about physical function)."|Week 6|Intent to treat||mm||Standard Deviation|Mean
764557|NCT00665431|Secondary|Mean Change From Baseline in American Pain Society Patient Outcome Questionnaire (APS-POQ)Total Interference Caused by Pain.|For APS-POQ score is the change from Baseline scores calculated for each subject through Day 7. Scale 0 through 70, where 0=no pain interference and 70=complete interference.|Baseline and Day 7|Intent to treat||Units on a scale||Standard Deviation|Mean
764558|NCT00665431|Primary|Change in Patient Global Assessment (PGA) Subscore From Baseline|PGA questionnaire. The patient global assessment (PGA) question asks about how the subject is doing considering his/her arthritis and is measured by a visual analog scale (VAS); 0 mm (very poor) 100 mm (excellent). The outcome measures a change from baseline PGA in mm.|12 Weeks|Analysis Population: Baseline + took >= 1 dose + >= 1 post-baseline PGA efficacy evaluation (intent-to-treat population). Used Last Observation Carried Forward||mm||Standard Deviation|Mean
764559|NCT00665431|Primary|Change in Western Ontario and McMaster Universities (WOMAC) Function Questionnaire Subscore From Baseline|"WOMAC function questionnaire (VAS). The 17 questions about function all use visual analog scale (VAS) of 100 mm; 0 mm being no pain and 100 mm being extreme pain. The outcome measures a change in WOMAC pain from baseline (in mm).
The Western Ontario and McMaster Universities (WOMAC) is a self-administered, patient-reported health status questionnaire that is designed to capture elements of pain, stiffness and physical disability in patients with OA of the knee and/or hip joints. The index consists of 24 questions (5 questions about pain, 2 on stiffness and 17 about physical function)."|12 Weeks|Analysis Population: Baseline + took >= 1 dose + >= 1 post-baseline WOMAC efficacy evaluation (intent-to-treat population). Used Last Observation Carried Forward||mm||Standard Deviation|Mean
764560|NCT00665431|Primary|Change in Western Ontario and McMaster Universities (WOMAC) Pain Questionnaire Subscore From Baseline|"Western Ontario and McMaster Universities (WOMAC) pain questionnaire has 5 questions on pain all use visual analog scale (VAS) of 100 mm, with 0 mm being no pain and 100 mm being extreme pain. The outcome measures a change in WOMAC pain at 12 weeks from baseline (in mm). WOMAC is a self-administered, patient-reported health status questionnaire designed to capture elements of pain, stiffness and physical disability in patients with OA of the knee and/or hip joints. It consists of 24 questions (5 questions about pain, 2 on stiffness and 17 about physical function)."|Baseline and 12 Weeks|Analysis Population: Baseline + took >= 1 dose + >= 1 post-baseline WOMAC efficacy evaluation (intent-to-treat population). Used Last Observation Carried Forward||mm||Standard Deviation|Mean
764561|NCT00665444|Secondary|Hamilton Rating Scale for Depression||3 months||||||
764562|NCT00665444|Secondary|Young Mania Rating Scale||3 months||||||
764563|NCT00665444|Secondary|Quality of Life Enjoyment Questionnaire||3 months||||||
764564|NCT00665444|Secondary|Global Assessment of Functioning||3 months||||||
764617|NCT00665925|Secondary|Aspartate Aminotransferase (AST) >3-5x Upper Limit of Normal (ULN)|The number of participants with AST (a test of liver function) values greater than 3 to 5 times the ULN|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.||Participants|||Number
764565|NCT00665444|Primary|Epworth Sleepiness Scale (General Level of Daytime Sleepiness)|0-the study was terminated early by the study sponsor due to low enrollment numbers. Only one participant completed the study in its duration and the study was terminated before any outcome data could be analyzed.|3 month|0-the study was terminated early by the study sponsor due to low enrollment numbers. Only one participant completed the study in its duration and the study was terminated before any outcome data could be analyzed.|||||
764566|NCT00665444|Primary|BodyMedia Armband (Sleep/Wake and Activity/Inactivity Patterns),|0-the study was terminated early by the study sponsor due to low enrollment numbers. Only one participant completed the study in its duration and the study was terminated before any outcome data could be analyzed.|3 months|0-the study was terminated early by the study sponsor due to low enrollment numbers. Only one participant completed the study in its duration and the study was terminated before any outcome data could be analyzed.|||||
764567|NCT00665470|Primary|Toxicity as Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) V3.0|Here is the number of participants with adverse events. For a detailed list of participants with adverse events, see the adverse event module.|16 months|||Participants|||Number
764568|NCT00665470|Primary|Response|Response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is a disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progression (PD) is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.|30 months|||Participants|||Number
764569|NCT00665626|Secondary|Absolute Neutrophil Count (ANC) <1500/mm3|The number of participants with ANC values less than 1500/mm3|Any time between baseline and 3 months|Intent-to-treat population||Participants|||Number
764570|NCT00665626|Secondary|Bilirubin >2x Upper Limit of Normal (ULN)|The number of participants with bilirubin (a test of liver function) values greater than 2 times the ULN|Any time between baseline and 3 months|Intent-to-treat population||Participants|||Number
764571|NCT00665626|Secondary|Bilirubin >1.5x Upper Limit of Normal (ULN)|The number of participants with bilirubin (a test of liver function) values greater than 1.5 times the ULN|Any time between baseline and 3 months|Intent-to-treat population||Participants|||Number
764572|NCT00665626|Secondary|Alkaline Phosphatase >1.5x Upper Limit of Normal (ULN) and >1.5x Baseline|The number of participants with alkaline phosphatase (a test of liver function) values greater than 1.5 times the ULN and greater than 1.5 times baseline|Any time between baseline and 3 months|Intent-to-treat population||Participants|||Number
764573|NCT00665626|Secondary|Aspartate Aminotransferase (AST) >10x Upper Limit of Normal (ULN)|The number of participants with AST (a test of liver function) values greater than 10 times the ULN|Any time between baseline and 3 months|Intent-to-treat population||Participants|||Number
764574|NCT00665626|Secondary|Aspartate Aminotransferase (AST) >5-10x Upper Limit of Normal (ULN)|The number of participants with AST (a test of liver function) values greater than 5 to 10 times the ULN|Any time between baseline and 3 months|Intent-to-treat population||Participants|||Number
764575|NCT00665626|Secondary|Aspartate Aminotransferase (AST) >3-5x Upper Limit of Normal (ULN)|The number of participants with AST (a test of liver function) values greater than 3 to 5 times the ULN|Any time between baseline and 3 months|Intent-to-treat population||Participants|||Number
764576|NCT00665626|Secondary|Aspartate Aminotransferase (AST) >3x Upper Limit of Normal (ULN)|The number of participants with AST (a test of liver function) values greater than 3 times the ULN|Any time between baseline and 3 months|Intent-to-treat population||Participants|||Number
764577|NCT00665626|Secondary|Aspartate Aminotransferase (AST) >2-3x Upper Limit of Normal (ULN)|The number of participants with AST (a test of liver function) values greater than 2 to 3 times the ULN|Any time between baseline and 3 months|Intent-to-treat population||Participants|||Number
764578|NCT00665626|Secondary|Aspartate Aminotransferase (AST) >1.5-2x Upper Limit of Normal (ULN)|The number of participants with AST (a test of liver function) values greater than 1.5 to 2 times the ULN|Any time between baseline and 3 months|Intent-to-treat population||Participants|||Number
764579|NCT00665626|Secondary|Aspartate Aminotransferase (AST) >1.5x Upper Limit of Normal (ULN)|The number of participants with AST (a test of liver function) values greater than 1.5 times the ULN|Any time between baseline and 3 months|Intent-to-treat population||Participants|||Number
764580|NCT00665626|Secondary|Alanine Aminotransferase (ALT) >10x Upper Limit of Normal (ULN)|The number of participants with ALT (a test of liver function) values greater than 10 times the ULN|Any time between baseline and 3 months|Intent-to-treat population||Participants|||Number
764581|NCT00665626|Secondary|Alanine Aminotransferase (ALT) >5-10x Upper Limit of Normal (ULN)|The number of participants with ALT (a test of liver function) values greater than 5 to 10 times the ULN|Any time between baseline and 3 months|Intent-to-treat population||Participants|||Number
764582|NCT00665626|Secondary|Alanine Aminotransferase (ALT) >3-5x Upper Limit of Normal (ULN)|The number of participants with ALT (a test of liver function) values greater than 3 to 5 times the ULN|Any time between baseline and 3 months|Intent-to-treat population||Participants|||Number
764583|NCT00665626|Secondary|Alanine Aminotransferase (ALT) >3x Upper Limit of Normal (ULN)|The number of participants with ALT (a test of liver function) values greater than 3 times the ULN|Any time between baseline and 3 months|Intent-to-treat population||Participants|||Number
764584|NCT00665626|Secondary|Alanine Aminotransferase (ALT) >2-3x Upper Limit of Normal (ULN)|The number of participants with ALT (a test of liver function) values greater than 2 to 3 times the ULN|Any time between baseline and 3 months|Intent-to-treat population||Participants|||Number
764585|NCT00665626|Secondary|Alanine Aminotransferase (ALT) >1.5-2x Upper Limit of Normal (ULN)|The number of participants with ALT (a test of liver function) values greater than 1.5 to 2 times the ULN|Any time between baseline and 3 months|Intent-to-treat population||Participants|||Number
764586|NCT00665626|Secondary|Alanine Aminotransferase (ALT) >1.5x Upper Limit of Normal (ULN)|The number of participants with ALT (a test of liver function) values greater than 1.5 times the ULN|Any time between baseline and 3 months|Intent-to-treat population||Participants|||Number
772079|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 1|Subject Satisfaction - overall function|6 months post-surgery|||% satisfactory or somewhat satisfactory|||Number
764587|NCT00665626|Secondary|Rheumatoid Arthritis Magnetic Resonance Imaging Scoring (RAMRIS) Synovitis Score at 3 Months|Change from baseline in RAMRIS synovitis score (a measure of inflammation in the joints of the hands and wrists), calculated as the score at 3 months minus the score at baseline. The synovitis score runs from 0 to 24 with lower values indicating a better clinical condition. A negative change indicates an improvement in symptoms.|Baseline to 3 months|Intent-to-treat population with available data and received study drug. The discrepancy in the lower number of subjects than those in the ITT population is because 43 subjects either never had a complete set of MRIs (pre and post-study) or had uninterpretable results.||Score||Standard Deviation|Mean
764588|NCT00665626|Secondary|Rheumatoid Arthritis Magnetic Resonance Imaging Scoring (RAMRIS) Osteitis Score at 3 Months|Change from baseline in RAMRIS osteitis score (a measure of bone inflammation in the hands and wrists), calculated as the score at 3 months minus the score at baseline. The osteitis score runs from 0 to 75 with lower values indicating a better clinical condition. A negative change indicates an improvement in symptoms.|Baseline to 3 months|Intent-to-treat population with available data and received study drug. The discrepancy in the lower number of subjects than those in the ITT population is because 43 subjects either never had a complete set of MRIs (pre and post-study) or had uninterpretable results.||Score||Standard Deviation|Mean
764589|NCT00665626|Secondary|Rheumatoid Arthritis Magnetic Resonance Imaging Scoring (RAMRIS) Erosion Score at 3 Months|Change from baseline in RAMRIS erosion score (a measure of bone erosion in the hands and wrists), calculated as the score at 3 months minus the score at baseline. The erosion score runs from 0 to 250 with lower values indicating a better clinical condition. A negative change indicates an improvement in symptoms.|Baseline to 3 months|Intent-to-treat population with available data and received study drug. The discrepancy in the lower number of subjects than those in the ITT population is because 43 subjects either never had a complete set of MRIs (pre and post-study) or had uninterpretable results.||Score||Standard Deviation|Mean
764590|NCT00665626|Secondary|American College of Rheumatology 20 (ACR20) Response at Week 2|The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and CRP or ESR, whichever was elevated at baseline, after 2 weeks|2 weeks|Intent-to-treat population||Participants|||Number
764591|NCT00665626|Secondary|American College of Rheumatology 20 (ACR20) Response at Week 1|The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and CRP or ESR, whichever was elevated at baseline, after 1 week.|1 week|Intent-to-treat population||Participants|||Number
764592|NCT00665626|Secondary|Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 3 Months|Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity.|3 months|Intent-to-Treat Population with ESR as Primary Phase Reactant||Participants|||Number
764593|NCT00665626|Secondary|Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 3 Months|Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms|3 months|Intent-to-Treat Population with ESR as Primary Phase Reactant||Participants|||Number
764594|NCT00665626|Secondary|Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 3 Months|Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity.|3 months|Intent-to-Treat Population with CRP as Primary Phase Reactant||Participants|||Number
764595|NCT00665626|Secondary|Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 3 Months|Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms|3 months|Intent-to-Treat Population with CRP as Primary Phase Reactant||Participants|||Number
764596|NCT00665626|Secondary|American College of Rheumatology Index of Improvement (ACRn) at 3 Months|The index of improvement in RA, where 0 indicates no improvement and 100 indicates a 100% improvement across all signs and symptoms of RA after 3 months of treatment|3 months|Intent-to-treat population||Score||Standard Deviation|Mean
764597|NCT00665626|Secondary|American College of Rheumatology 70 (ACR70) Response at 3 Months|The number of participants with greater than or equal to 70% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and CRP or ESR, whichever was elevated at baseline, after 3 months|3 months|Intent-to-treat population||Participants|||Number
764598|NCT00665626|Secondary|American College of Rheumatology 50 (ACR50) Response at 3 Months|The number of participants with greater than or equal to 50% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and CRP or ESR, whichever was elevated at baseline, after 3 months|3 months|Intent-to-treat population||Participants|||Number
764599|NCT00665626|Primary|American College of Rheumatology 20 (ACR20) Response at 3 Months|The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, Health Assessment Questionnaire-Disability Index (HAQ-DI); and CRP or ESR, after 3 months|3 months|Intent-to-treat population||Participants|||Number
764618|NCT00665925|Secondary|Aspartate Aminotransferase (AST) >3x Upper Limit of Normal (ULN)|The number of participants with AST (a test of liver function) values greater than 3 times the ULN|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.||Participants|||Number
764600|NCT00665704|Secondary|Patient Feedback to Evaluate the Website|Formative evaluation during pre-testing included qualitative feedback on the: 1) ability to accomplish tasks; 2) ability to accomplish goals with skill and speed; 3) ability to operate the system; and 4) satisfaction. For the 9 veteran smokers that actually tried to use the Tobacco Tactics website to quit smoking, we were able to determine: 1) the number of times they signed onto the website; 2) the time spent on the website; and 3) the number of times each module was accessed.|30 days post intervention|||participants|||Number
764601|NCT00665704|Primary|Self Reported 30 Day Smoking Quit Rate|Impact evaluation was the 30-day quit rates of the 9 veteran smokers that agreed to use the website.|30 days post intervention|||participants|||Number
764602|NCT00665847|Secondary|The Emergence of Non-nucleoside Reverse Transcriptase Inhibitor Resistance-associated Mutations (NNRTI RAMs) in Patients Classified as Virologic Failures|Virologic failure (lack of response) was defined as: plasma viral load decline of < 0.5 log10 from Baseline by Week 8 and/or plasma viral load decline of <1.0 log10 from Baseline by Week 12. Virologic failure (loss of response) was defined as 2 consecutive measurements of plasma viral load > 0.5 log10 above the nadir after a minimum of 12 weeks of treatment. The table below provides data for 41 viologic failures of which 30 had mutation data available. In the table below, only the 4 most frequently emerging mutations are presented (emerging in at least 3 patients).|Baseline and Endpoint (up to Week 48)|The patients in the intent-to-treat (ITT) population classified as virologic failures were used for this analysis.||Patients|||Number
764603|NCT00665847|Secondary|The Change From Baseline in CD4 Cell Counts Over Time||Baseline, Week 48|The intent-to-treat (ITT) population, i.e. all patients who had been enrolled and taken Etravirine/TMC125 (ETR) at least once, regardless of their compliance with the protocol was used for this analysis.||10E6 cells/L||Standard Error|Mean
764604|NCT00665847|Secondary|Change From Baseline in Human Immunodeficiency Virus – Type 1 (HIV-1) Ribonucleic Acid (RNA) in Plasma Over Time||Baseline, Week 48|The intent-to-treat (ITT) population, i.e. all patients who had been enrolled and taken Etravirine/TMC125 (ETR) at least once, regardless of their compliance with the protocol was used for this analysis.||log10 copies/mL||Standard Error|Mean
764605|NCT00665847|Secondary|Percentage of Patients With Virologic Response at Week 24|Virologic response was defined as the percentage of patients with plasma viral load < 50 copies/mL at Week 24 calculated according to the non-completer=failure (NC=F) imputation method.|Week 24|The intent-to-treat (ITT) population, i.e. all patients who had been enrolled and taken Etravirine/TMC125 (ETR) at least once, regardless of their compliance with the protocol was used for this analysis.||Percentage of Patients|||Number
764606|NCT00665847|Secondary|Population Pharmacokinetic (PK) Estimates of Etravirine/TMC125 (ETR): Maximum Plasma Concentration (Cmax)|Etravirine/TMC125 (ETR) Cmax was approximated for each individual using the median value of plasma ETR concentrations taken 4 hours postdose (± 1 hour), when available, on the day of the Week 4 visit as shown in the table below.|Week 4|The intent-to-treat (ITT) population, i.e. all patients who had been enrolled and taken Etravirine/TMC125 (ETR) at least once, regardless of their compliance with the protocol was used for this analysis.||ng/mL||Standard Deviation|Mean
764607|NCT00665847|Secondary|Population Pharmacokinetic (PK) Estimates of Etravirine/TMC125 (ETR): Trough Plasma Concentration (C0h)||Week 48|"The intent-to-treat (ITT) population, i.e. all patients who had been enrolled and taken ETR at least once, regardless of their compliance with the protocol was used for this analysis. The table below shows results for Overall (children and adolescents combined)."||ng/mL||Standard Deviation|Mean
764608|NCT00665847|Secondary|Population Pharmacokinetic (PK) Estimates of Etravirine/TMC125 (ETR): Area Under the Plasma Concentration-time Curve Over 12 Hours at Steady-state (AUC12h)|The AUC12h is a Bayesian estimation based on a population pharmacokinetic model and sparse samples collected at each visit over the duration of trial. For each sparse sample taken, the time blood sample was recorded as well as the time of etravirine intake just prior to the time of blood sample.|Weeks 4-48|"The intent-to-treat (ITT) population, i.e. all patients who had been enrolled and taken ETR at least once, regardless of their compliance with the protocol was used for this analysis. The table below shows results for Overall (children and adolescents combined)."||ng.h/mL||Standard Deviation|Mean
764609|NCT00665847|Primary|The Percentage of Patients With Treatment-emergent Adverse Events (TEAEs)|The percentage of patients with a treatment-emergent adverse event (TEAE) (defined as an event that occurred in the 48-week treatment period during which it emerged [i.e. started or worsened in severity, relation, or other attribute], and not in the subsequent study periods, even if the event continued to be present] are provided below. Adverse events were graded from 1 to 4 in severity using the Division of Acquired Immunodeficiency Syndrome severity scale (grade 1 being less severe and grade 4 being more severe). ETR=etravirine/TMC125; OBR=optimized background regimen|48 weeks|The safety analysis was done on the intent-to-treat (ITT) population, which included all patients who received at least one dose of investigational medication.||Percentage of patients|||Number
764610|NCT00665847|Primary|The Number of Patients With Treatment-emergent Adverse Events (TEAEs)|A treatment-emergent adverse event (TEAE) was defined as an event that occurred in the 48-week treatment period during which it emerged (i.e. started or worsened in severity, relation, or other attribute), and not in the subsequent study periods, even if the event continued to be present. Adverse events were graded from 1 to 4 in severity using the Division of Acquired Immunodeficiency Syndrome severity scale (grade 1 being less severe and grade 4 being more severe). ETR=etravirine/TMC125; OBR=optimized background regimen|48 weeks|The safety analysis was done on the intent-to-treat (ITT) population, which included all patients who received at least one dose of investigational medication.||Patients|||Number
764611|NCT00665925|Secondary|Absolute Neutrophil Count (ANC) <1500/mm3|The number of participants with ANC (a test of liver function) values lower than 1500/mm3|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.||Participants|||Number
764612|NCT00665925|Secondary|Bilirubin >2 x Upper Limit of Normal (ULN)|The number of participants with bilirubin (a test of liver function) values greater than 2 times the ULN|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.||Participants|||Number
764613|NCT00665925|Secondary|Bilirubin >1.5 x Upper Limit of Normal (ULN)|The number of participants with bilirubin (a test of liver function) values greater than 1.5 times the ULN|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.||Participants|||Number
772080|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 1|Subject Satisfaction - overall function|3 months post-surgery|||% satisfactory or somewhat satisfactory|||Number
764626|NCT00665925|Secondary|Alanine Aminotransferase (ALT) >2-3x Upper Limit of Normal (ULN)|The number of participants with ALT (a test of liver function) values greater than 2 to 3 times the ULN|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.||Participants|||Number
764627|NCT00665925|Secondary|Alanine Aminotransferase (ALT) >1.5-2x Upper Limit of Normal (ULN)|The number of participants with ALT (a test of liver function) values greater than 1.5 to 2 times the ULN|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.||Participants|||Number
764628|NCT00665925|Secondary|Alanine Aminotransferase (ALT) >1.5x Upper Limit of Normal (ULN)|The number of participants with ALT (a test of liver function) values greater than 1.5 times the ULN|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.||Participants|||Number
764629|NCT00665925|Secondary|Short Form Health Survey (SF-36) Mental Component Summary (MCS) at 6 Months|Change from baseline in the MCS of the SF-36 (which assesses health and wellbeing), calculated as the score at 6 months minus the score at baseline. The MCS ranges from 0 to 100 with 100 indicating the highest level of functioning possible. A positive change indicates an improvement in MCS after treatment|Baseline to 6 months|Intent-to-treat population with available data and received study drug.||Score||Standard Deviation|Mean
764630|NCT00665925|Secondary|Short Form Health Survey (SF-36) Physical Component Summary (PCS) at 6 Months|Change from baseline in the PCS of the SF-36 (which assesses health and wellbeing), calculated as the score at 6 months minus the score at baseline. The PCS ranges from 0 to 100 with 100 indicating the highest level of functioning possible. A positive change indicates an improvement in PCS after treatment|Baseline to 6 months|Intent-to-treat population with available data and received study drug.||Score||Standard Deviation|Mean
764631|NCT00665925|Secondary|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at 6 Months|Change from baseline in FACIT-F, which is a patient-reported 13-item questionnaire that assesses fatigue, calculated as the score at 6 months minus the score at baseline. The FACIT-F runs from 0 to 52 with lower scores indicating higher fatigue. A positive change from baseline indicates an improvement in fatigue after treatment.|Baseline to 6 months|Intent-to-treat population with available data and received study drug.||Score||Standard Deviation|Mean
764632|NCT00665925|Secondary|Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 6 Months|Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity|6 months|Intent-to-Treat Population with ESR as Primary Phase Reactant with available data and received study drug.||Participants|||Number
764633|NCT00665925|Secondary|Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 5 Months|Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity|5 months|Intent-to-Treat Population with ESR as Primary Phase Reactant with available data and received study drug.||Participants|||Number
764634|NCT00665925|Secondary|Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 4 Months|Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity|4 months|Intent-to-Treat Population with ESR as Primary Phase Reactant with available data and received study drug.||Participants|||Number
764635|NCT00665925|Secondary|Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 3 Months|Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity|3 months|Intent-to-Treat Population with ESR as Primary Phase Reactant with available data and received study drug.||Participants|||Number
764636|NCT00665925|Secondary|Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 2 Months|Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity|2 months|Intent-to-Treat Population with ESR as Primary Phase Reactant with available data and received study drug.||Participants|||Number
764637|NCT00665925|Secondary|Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 1 Month|Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity|1 month|Intent-to-Treat Population with ESR as Primary Phase Reactant with available data and received study drug.||Participants|||Number
764638|NCT00665925|Secondary|Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 6 Months|Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms|6 months|Intent-to-Treat Population with ESR as Primary Phase Reactant with available data and received study drug.||Participants|||Number
764639|NCT00665925|Secondary|Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 5 Months|Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms|5 months|Intent-to-Treat Population with ESR as Primary Phase Reactant with available data and received study drug.||Participants|||Number
768424|NCT00703677|Secondary|Geriatric Depression Scale(GDS)-15:Change From Baseline|The GDS-15 is a 15-item instrument used to screen for depression in the elderly. Subjects will be assessed at the Screening Visit and at Week 28.|28 weeks||||||
764640|NCT00665925|Secondary|Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 4 Months|Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms|4 months|Intent-to-Treat Population with ESR as Primary Phase Reactant with available data and received study drug.||Participants|||Number
764641|NCT00665925|Secondary|Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 3 Months|Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms|3 months|Intent-to-Treat Population with ESR as Primary Phase Reactant with available data and received study drug.||Participants|||Number
764642|NCT00665925|Secondary|Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 2 Months|Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms|2 months|Intent-to-Treat Population with ESR as Primary Phase Reactant with available data and received study drug.||Participants|||Number
764643|NCT00665925|Secondary|Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 1 Month|Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms|1 month|Intent-to-Treat Population with ESR as Primary Phase Reactant with available data and received study drug.||Participants|||Number
764644|NCT00665925|Secondary|Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 6 Months|Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity|6 months|Intent-to-Treat Population with CRP as Primary Phase Reactant with available data and received study drug.||Participants|||Number
764645|NCT00665925|Secondary|Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 5 Months|Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity|5 months|Intent-to-Treat Population with CRP as Primary Phase Reactant with available data and received study drug.||Participants|||Number
764646|NCT00665925|Secondary|Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 4 Months|Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity|4 months|Intent-to-Treat Population with CRP as Primary Phase Reactant with available data and received study drug.||Participants|||Number
764647|NCT00665925|Secondary|Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 3 Months|Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity|3 months|Intent-to-Treat Population with CRP as Primary Phase Reactant with available data and received study drug.||Participants|||Number
764648|NCT00665925|Secondary|Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 2 Months|Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity|2 months|Intent-to-Treat Population with CRP as Primary Phase Reactant with available data and received study drug.||Participants|||Number
764649|NCT00665925|Secondary|Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 1 Month|Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity|1 month|Intent-to-Treat Population with CRP as Primary Phase Reactant with available data and received study drug.||Participants|||Number
764650|NCT00665925|Secondary|Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 6 Months|Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms|6 months|Intent-to-Treat Population with CRP as Primary Phase Reactant with available data and received study drug.||Participants|||Number
764651|NCT00665925|Secondary|Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 5 Months|Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms|5 months|Intent-to-Treat Population with CRP as Primary Phase Reactant with available data and received study drug.||Participants|||Number
764652|NCT00665925|Secondary|Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 4 Months|Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms|4 months|Intent-to-Treat Population with CRP as Primary Phase Reactant with available data and received study drug.||Participants|||Number
764653|NCT00665925|Secondary|Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 3 Months|Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms|3 months|Intent-to-Treat Population with CRP as Primary Phase Reactant with available data and received study drug.||Participants|||Number
764654|NCT00665925|Secondary|Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 2 Months|Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms|2 months|Intent-to-Treat Population with CRP as Primary Phase Reactant with available data and received study drug.||Participants|||Number
764655|NCT00665925|Secondary|Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 1 Month|Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms|1 month|Intent-to-Treat Population with CRP as Primary Phase Reactant with available data and received study drug.||Participants|||Number
764656|NCT00665925|Secondary|American College of Rheumatology Index of Improvement (ACRn) at 6 Months|The index of improvement in RA, where 0 indicates no improvement and 100 indicates a 100% improvement across all signs and symptoms of RA after 6 months of treatment|6 months|Intent-to-treat population with available data and received study drug.||Score||Standard Deviation|Mean
764657|NCT00665925|Secondary|American College of Rheumatology Index of Improvement (ACRn) at 5 Months|The index of improvement in RA, where 0 indicates no improvement and 100 indicates a 100% improvement across all signs and symptoms of RA after 5 months of treatment|5 months|Intent-to-treat population with available data and received study drug.||Score||Standard Deviation|Mean
764658|NCT00665925|Secondary|American College of Rheumatology Index of Improvement (ACRn) at 4 Months|The index of improvement in RA, where 0 indicates no improvement and 100 indicates a 100% improvement across all signs and symptoms of RA after 4 months of treatment|4 months|Intent-to-treat population with available data and received study drug.||Score||Standard Deviation|Mean
764659|NCT00665925|Secondary|American College of Rheumatology Index of Improvement (ACRn) at 3 Months|The index of improvement in RA, where 0 indicates no improvement and 100 indicates a 100% improvement across all signs and symptoms of RA after 3 months of treatment|3 months|Intent-to-treat population with available data and received study drug.||Score||Standard Deviation|Mean
764660|NCT00665925|Secondary|American College of Rheumatology Index of Improvement (ACRn) at 2 Months|The index of improvement in RA, where 0 indicates no improvement and 100 indicates a 100% improvement across all signs and symptoms of RA after 2 months of treatment|2 months|Intent-to-treat population with available data and received study drug.||Score||Standard Deviation|Mean
764661|NCT00665925|Secondary|American College of Rheumatology Index of Improvement (ACRn) at 6 Weeks|The index of improvement in RA, where 0 indicates no improvement and 100 indicates a 100% improvement across all signs and symptoms of RA after 6 weeks of treatment|6 weeks|Intent-to-treat population with available data and received study drug.||Score||Standard Deviation|Mean
764662|NCT00665925|Secondary|American College of Rheumatology Index of Improvement (ACRn) at 1 Month|The index of improvement in RA, where 0 indicates no improvement and 100 indicates a 100% improvement across all signs and symptoms of RA after 1 month of treatment|1 month|Intent-to-treat population with available data and received study drug.||Score||Standard Deviation|Mean
764663|NCT00665925|Secondary|American College of Rheumatology Index of Improvement (ACRn) at 2 Weeks|The index of improvement in RA, where 0 indicates no improvement and 100 indicates a 100% improvement across all signs and symptoms of RA after 2 weeks of treatment|2 weeks|Intent-to-treat population with available data and received study drug.||Score||Standard Deviation|Mean
764664|NCT00665925|Secondary|American College of Rheumatology Index of Improvement (ACRn) at 1 Week|The index of improvement in RA, where 0 indicates no improvement and 100 indicates a 100% improvement across all signs and symptoms of RA after 1 week of treatment|1 week|Intent-to-treat population with available data and received study drug.||Score||Standard Deviation|Mean
764665|NCT00665925|Secondary|American College of Rheumatology 70 (ACR70) Response at 6 Months|The number of participants with greater than or equal to 70% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 6 months|6 months|Intent-to-treat population with available data and received study drug.||Participants|||Number
764666|NCT00665925|Secondary|American College of Rheumatology 70 (ACR70) Response at 5 Months|The number of participants with greater than or equal to 70% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 5 months|5 months|Intent-to-treat population with available data and received study drug.||Participants|||Number
764667|NCT00665925|Secondary|American College of Rheumatology 70 (ACR70) Response at 4 Months|The number of participants with greater than or equal to 70% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 4 months|4 months|Intent-to-treat population with available data and received study drug.||Participants|||Number
764668|NCT00665925|Secondary|American College of Rheumatology 70 (ACR70) Response at 3 Months|The number of participants with greater than or equal to 70% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 3 months|3 months|Intent-to-treat population with available data and received study drug.||Participants|||Number
774282|NCT00746590|Secondary|Disease Control Rate Defined as the Proportion of Subjects With Either Complete or Partial Response or Stable Disease||Approximately 12 weeks or more after first treatment with Prolarix||||||
764669|NCT00665925|Secondary|American College of Rheumatology 70 (ACR70) Response at 2 Months|The number of participants with greater than or equal to 70% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 2 months|2 months|Intent-to-treat population with available data and received study drug.||Participants|||Number
764670|NCT00665925|Secondary|American College of Rheumatology 70 (ACR70) Response at 6 Weeks|The number of participants with greater than or equal to 70% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 6 weeks|6 weeks|Intent-to-treat population with available data and received study drug.||Participants|||Number
764671|NCT00665925|Secondary|American College of Rheumatology 70 (ACR70) Response at 1 Month|The number of participants with greater than or equal to 70% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 1 month|1 month|Intent-to-treat population with available data and received study drug.||Participants|||Number
764672|NCT00665925|Secondary|American College of Rheumatology 70 (ACR70) Response at 2 Weeks|The number of participants with greater than or equal to 70% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 2 weeks|2 weeks|Intent-to-treat population with available data and received study drug.||Participants|||Number
764673|NCT00665925|Secondary|American College of Rheumatology 70 (ACR70) Response at 1 Week|The number of participants with greater than or equal to 70% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 1 week|1 week|Intent-to-treat population with available data and received study drug.||Participants|||Number
764674|NCT00665925|Secondary|American College of Rheumatology 50 (ACR50) Response at 6 Months|The number of participants with greater than or equal to 50% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 6 months|6 months|Intent-to-treat population with available data and received study drug.||Participants|||Number
764675|NCT00665925|Secondary|American College of Rheumatology 50 (ACR50) Response at 5 Months|The number of participants with greater than or equal to 50% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 5 months|5 months|Intent-to-treat population with available data and received study drug.||Participants|||Number
764676|NCT00665925|Secondary|American College of Rheumatology 50 (ACR50) Response at 4 Months|The number of participants with greater than or equal to 50% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 4 months|4 months|Intent-to-treat population with available data and received study drug.||Participants|||Number
764677|NCT00665925|Secondary|American College of Rheumatology 50 (ACR50) Response at 3 Months|The number of participants with greater than or equal to 50% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 3 months|3 months|Intent-to-treat population with available data and received study drug.||Participants|||Number
764678|NCT00665925|Secondary|American College of Rheumatology 50 (ACR50) Response at 2 Months|The number of participants with greater than or equal to 50% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 2 months|2 months|Intent-to-treat population with available data and received study drug.||Participants|||Number
764679|NCT00665925|Secondary|American College of Rheumatology 50 (ACR50) Response at 6 Weeks|The number of participants with greater than or equal to 50% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 6 weeks|6 weeks|Intent-to-treat population with available data and received study drug.||Participants|||Number
764680|NCT00665925|Secondary|American College of Rheumatology 50 (ACR50) Response at 1 Month|The number of participants with greater than or equal to 50% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 1 month|1 month|Intent-to-treat population with available data and received study drug.||Participants|||Number
764681|NCT00665925|Secondary|American College of Rheumatology 50 (ACR50) Response at 2 Weeks|The number of participants with greater than or equal to 50% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 2 weeks|2 weeks|Intent-to-treat population with available data and received study drug.||Participants|||Number
764682|NCT00665925|Secondary|American College of Rheumatology 50 (ACR50) Response at 1 Week|The number of participants with greater than or equal to 50% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 1 week|1 week|Intent-to-treat population with available data and received study drug.||Participants|||Number
764683|NCT00665925|Secondary|American College of Rheumatology 20 (ACR20) Response at 5 Months|The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 5 months|5 months|Intent-to-treat population with available data and received study drug.||Participants|||Number
764684|NCT00665925|Secondary|American College of Rheumatology 20 (ACR20) Response at 4 Months|The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 4 months|4 months|Intent-to-treat population with available data and received study drug.||Participants|||Number
764685|NCT00665925|Secondary|American College of Rheumatology 20 (ACR20) Response at 3 Months|The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 3 months|3 months|Intent-to-treat population with available data and received study drug.||Participants|||Number
764686|NCT00665925|Secondary|American College of Rheumatology 20 (ACR20) Response at 2 Months|The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 2 months|2 months|Intent-to-treat population with available data and received study drug.||Participants|||Number
764687|NCT00665925|Secondary|American College of Rheumatology 20 (ACR20) Response at 6 Weeks|The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 6 weeks|6 weeks|Intent-to-treat population with available data and received study drug.||Participants|||Number
764688|NCT00665925|Secondary|American College of Rheumatology 20 (ACR20) Response at 1 Month|The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 1 month|1 month|Intent-to-treat population with available data and received study drug.||Participants|||Number
764689|NCT00665925|Secondary|American College of Rheumatology 20 (ACR20) Response at 2 Weeks|The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 2 weeks|2 weeks|Intent-to-treat population with available data and received study drug.||Participants|||Number
764690|NCT00665925|Secondary|American College of Rheumatology 20 (ACR20) Response at 1 Week|The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 1 week|1 week|Intent-to-treat population with available data and received study drug.||Participants|||Number
764691|NCT00665925|Primary|American College of Rheumatology 20 (ACR20) Response at 6 Months|The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 6 months|6 months|Intent-to-treat population includes all subjects that received study drug||Participants|||Number
764692|NCT00666029|Primary|Insulin Sensitivity Index|Insulin sensitivity index was assessed during the final steady state 30 minutes of a high dose hyperinsulinaemic euglycaemic clamp (insulin infusion rate 1.5 mIU/kg/min). During this part of the clamp, insulin was infused at 1.5mIU/kg/min and the glucose concentration was maintained at 5 mmol/L using a dextrose infusion. The whole body insulin mediated glucose disposal rate (M value - mg/kg/min) was estimated from the total amount of glucose infused during the last 30 minutes of the clamp. The mean of four serum insulin concentrations was taken during this 30 minutes to determine the steady state insulin concentration (I value - milliunits/litre). M value/I value defined the insulin sensitivity index.|6 months|There was missing data in four people in the atorvastatin arm and two people in the placebo arm||mg*kg^-1*min^-1*mIU^-1*L^-1||Standard Deviation|Mean
764693|NCT00666029|Primary|Muscle Microvascular Function|Skeletal muscle microvascular function assessed (Filtrass plethysmographic system) using a passive inductive transducer (Compumedics.dwl, Singen, Germany) and a small pressure step venous congestion protocol. Fluid filtration rate (Jv mL min-1 100 mL-1), measured from the slope of limb volume change in response to each pressure step (10 mmHg steps to 60 mmHg around the thigh) over the last 2 minutes of its application, to allow for completion of vascular filling, and plotted against cuff pressure (Pcuff). The slope of this relationship, at pressures above those giving rise to net filtration, is a measure of Kf, microvascular filtration capacity, a function of exchange surface area and permeability. The CV for Kf measurement was 14.5%.|6 months|There was missing data on two participants in the atorvastatin arm and two participants in the placebo arm.||10^3 mL*min^-1*100ml^-1*mmHg^-1||Standard Deviation|Mean
764701|NCT00666198|Primary|Number of Paritcipants With Treatment-Related Adverse Events by Age|A treatment-related adverse event was any untoward medical occurrence attributed to sildenafil citrate in a participant who received sildenafil citrate. Relatedness to sildenafil citrate was assessed by the physician/investigator. Participants with treatment related adverse events were counted by age to assess whether it was risk factor for the treatment related adverse events.|3 years|The safety analysis set comprised of participants who satisfied the inclusion criteria and had received sildenafil citrate at least once.||Paritcipants|||Number
768425|NCT00703677|Secondary|Frontal Assessment Battery (FAB): Change From Baseline|The FAB is a brief, 6-item instrument designed to assess executive function. Subjects will be assessed at baseline and at Week 28.|28 weeks||||||
764694|NCT00666198|Primary|Clinical Efficacy Rate by WHO Functional Classificaton of Severity|"Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of sildenafil citrate was assessed as “effective,” “ineffective” or unassessable by the physician/investigator. Overall effectiveness of sildenafil citrate was determined by the physician/investigator based on clinical symptoms, laboratory values, and other examinations such as echocardiogram. Participants achieved clinical effectiveness by severity (WHO functional classification of PAH;The grades range from Functional Class (FC) I, where the patient's disease does not affect their day-to-day activities, to FC IV, where patients are severely functionally impaired, even at rest. This functional classification system links) were counted to assess whether it contributes to the clinical effectiveness."|3 years|The effectiveness analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician/investigator based upon change in clinical symptoms and laboratory findings) at least once. Participants with observed effectiveness data were included in table.||Percentage of Participants|||Number
764695|NCT00666198|Primary|Clinical Efficacy Rate by Disease Type|"Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of sildenafil citrate was assessed as “effective,” “ineffective” or unassessable by the physician/investigator. Overall effectiveness of sildenafil citrate was determined by the physician/investigator based on clinical symptoms, laboratory values, and other examinations such as echocardiogram. Participants achieved clinical effectiveness by disease type were counted to assess whether it contributes to the clinical effectiveness.
* indicates Associated Pulmonary Arterial Hypertension (APAH). ** refers to Pulmonary Veno Occlusive Disease/Pulmonary Capillary Hemangiomatosis."|3 years|The effectiveness analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician/investigator based upon change in clinical symptoms and laboratory findings) at least once. Participants with observed effectiveness data were included in table.||Percentage of Participants|||Number
764696|NCT00666198|Primary|Clinical Efficacy Rate by Gender|"Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of sildenafil citrate was assessed as “effective,” “ineffective” or unassessable by the physician/investigator. Overall effectiveness of sildenafil citrate was determined by the physician/investigator based on clinical symptoms, laboratory values, and other examinations such as echocardiogram. Participants achieved clinical effectiveness by gender were counted to assess whether it contributes to the clinical effectiveness."|3 years|The effectiveness analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician/investigator based upon change in clinical symptoms and laboratory findings) at least once. Participants with observed effectiveness data were included in table.||Percentage of Participants|||Number
764697|NCT00666198|Primary|Clinical Efficacy Rate by Age|"Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of sildenafil citrate was assessed as “effective,” “ineffective” or unassessable by the physician/investigator. Overall effectiveness of sildenafil citrate was determined by the physician/investigator based on clinical symptoms, laboratory values, and other examinations such as echocardiogram. Participants achieved clinical effectiveness by age were counted to assess whether it contributes to the clinical effectiveness."|3 years|The effectiveness analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician/investigator based upon change in clinical symptoms and laboratory findings) at least once. Participants with observed effectiveness data were included in table.||Percentage of Participants|||Number
764698|NCT00666198|Primary|Number of Participants With Treatmnt-Related Adverse Events by WHO Functional Classification of Severity|A treatment-related adverse event was any untoward medical occurrence attributed to sildenafil citrate in a participant who received sildenafil citrate. Relatedness to sildenafil citrate was assessed by the physician/investigator. Participants with treatment related adverse events were counted by severity (WHO functional classification for PAH range;This system grades PAH severity according to the functional status of the patient. The grades range from Functional Class (FC) I, where the patient's disease does not affect their day-to-day activities, to FC IV, where patients are severely functionally impaired, even at rest. This functional classification system links symptoms with activity limitations, and allows clinicians to quickly predict disease progression and prognosis, as well as the need for specific treatment regimens, irrespective of the underlying etiology of PAH) to assess whether it was risk factor for the treatment related adverse events.|3 years|The safety analysis set comprised of participants who satisfied the inclusion criteria and had received sildenafil citrate at least once.||Participants|||Number
764699|NCT00666198|Primary|Number of Participants With Treatment-Related Adverse Events by Disease Type|"A treatment-related adverse event was any untoward medical occurrence attributed to sildenafil citrate in a participant who received sildenafil citrate. Relatedness to sildenafil citrate was assessed by the physician/investigator. Participants with treatment related adverse events were counted by disease type to assess whether it was risk factor for the treatment related adverse events.
* indicates Associated Pulmonary Arterial Hypertension (APAH). ** refers to Pulmonary Veno Occlusive Disease/Pulmonary Capillary Hemangiomatosis."|3 years|The safety analysis set comprised of participants who satisfied the inclusion criteria and had received sildenafil citrate at least once.||Participants|||Number
764700|NCT00666198|Primary|Number of Paritcipants With Treatment-Related Adverse Events by Gender|A treatment-related adverse event was any untoward medical occurrence attributed to sildenafil citrate in a participant who received sildenafil citrate. Relatedness to sildenafil citrate was assessed by the physician/investigator. Participants with treatment related adverse events were counted by gender to assess whether it was risk factor for the treatment related adverse events.|3 years|The safety analysis set comprised of participants who satisfied the inclusion criteria and had received sildenafil citrate at least once.||Paritcipants|||Number
765290|NCT00670007|Secondary|Percent Change in Lung Function as Measured by Forced Expiratory Volume in 1 Second (FEV1)||From baseline up to 2 years|ITT population. Subjects may not have been included in all efficacy analyses because of missing efficacy assessments.||Percent change from baseline||Standard Deviation|Mean
764702|NCT00666198|Primary|Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert|A treatment-related adverse event was any untoward medical occurrence attributed to sildenafil citrate in a participant who received sildenafil citrate. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to sildenafil citrate was assessed by the physician/investigator.|3 years|The safety analysis set comprised of participants who satisfied the inclusion criteria and had received sildenafil citrate at least once.||Participants|||Number
764703|NCT00666198|Primary|Number of Participants With Treatment-Related Adverse Events|A treatment-related adverse event was any untoward medical occurrence attributed to sildenafil citrate in a participant who received sildenafil citrate. A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to sildenafil citrate was assessed by the physician/investigator.|3 years|The safety analysis set comprised of participants who satisfied the inclusion criteria and had received sildenafil citrate at least once.||Participants|||Number
764704|NCT00666211|Primary|Pain Duration|Pain duration in hours 0 to 24|at 9 weeks|||hours||Standard Deviation|Mean
764705|NCT00666211|Primary|Pain-related Distress|Patients in each arm will each have 9 measures: daily scores averaged over 1 week with baseline to week 8. Pain-related distress scale is from 0 (no pain) to 10 (worst pain).|Baseline(Week 0) to week 8, Total time frame is 9 weeks.|||units on a scale||Standard Deviation|Mean
764706|NCT00666211|Secondary|Quality of Life|Each patient in each arm is scored on the Functional Assessment of Cancer Therapy-General (FACT-G) at baseline + week 8 with 4 related sub-scales (physical, social/family, emotional, functional well-being. To generate sub-scale scores, physical and emotional items are reverse coded & items are then summed, such that higher values indicate better quality of life. Thus, each sub-scale score ranges from 0 (not at all, worse outcome) to 4 (very much, better outcome) with a minimum total score of 0 (worst quality of life) to a maximum of 16 (good quality of life).|9 weeks|||scores on a scale||Standard Deviation|Mean
764707|NCT00666211|Secondary|Mood Disturbance|Patients in each arm will each have 5 measures on the Profile of Mood States-Short Form (POMS-SF): baseline + weeks 2, 4, 6, 8. The POMS-SF consists of 37 questions, querying 6 mood states (anxiety, depression, anger, confusion, fatigue, and vigor), with responses on a scale from 0 (not at all) to 4 (extremely). To generate a summary score, questions on vigor state are first recoded to reverse the scale, so that higher summary scores consistently indicate greater mood disturbance.|9 weeks|||units on a scale||Standard Deviation|Mean
764708|NCT00666211|Secondary|Interference in Daily Life Due to Pain|Patients in each arm will each have 5 measures on the Brief Pain Inventory (BPI) scale: baseline + weeks 2, 4, 6, 8. The BPI consists of 7 questions about interference of pain in daily life, answered on a scale of 0 (does not interfere) to 10 (completely interferes). The summary score is the average from the 7 questions, with higher score indicating greater interference due to pain.|9 weeks|||units on a scale||Standard Deviation|Mean
764709|NCT00666211|Secondary|Ability to Engage in Activities of Daily Living (ADL)|The Functional Assessment Screening Questionnaire (FASQ) scale is used, scored at baseline and at weeks 2, 4, 6, 8. The FASQ consists of 15 questions about ability to perform ADL with minimum score of 1 (easy to perform) to a maximum score of 5 (N/A, meaning someone else performs this activity for the patient or else the patient chooses not to do it). A summary mean score is generated with a minimum score of 1 and a maximum score of 5.|Baseline(Week 0) to week 8, Total time frame is 9 weeks.|||units on a scale||Standard Deviation|Mean
764710|NCT00666211|Primary|Pain Intensity|"Patients in each arm will each have 9 measures: daily scores averaged over 1 week with baseline to week 8:
Average daily pain intensity 0 (no pain) to 10 (worst) scale
Worst daily pain intensity 0 (no pain) to 10 (worst) scale"|Baseline(Week 0) to week 8, Total time frame is 9 weeks.|||units on a scale||Standard Deviation|Mean
764711|NCT00666224|Secondary|Percentage of Participants Who Converted to Clinically Definite Multiple Sclerosis (CDMS) During the Double-blind Period|Data from interim analysis with database lock on October 14, 2007. Conversion to CDMS as determined by the occurrence of a second clinical attack during the double-blind period. Poser criteria are: Two relapses and clinical evidence of two separate lesions; clinical evidence of one lesion and paraclinical evidence of another separate lesion. The two relapses must involve different parts of Central Nervous System and must be separated by a period of at least one month. Lesions are determined by Magnetic Resonance Imaging (MRI).|up to 3 years|Intent-to-Treat (ITT) analysis set.||percentage of total participants|||Number
764712|NCT00666224|Primary|Twenty-fifth Percentile (25%) Kaplan-Meier Estimates for Time From Randomization to Conversion to Clinically Definite Multiple Sclerosis (CDMS) During the Double-blind Period|Data from interim analysis with database lock on October 14, 2007. Due to the number of participants in the glatiramer acetate group that converted to CDMS (see outcome #6), the 25th percentile was considered when running the Kaplan-Meier estimate for time to conversion to CDMS. Conversion to CDMS is determined by the occurrence of the second clinical attack.|up to 3 years|Intent-to-Treat (ITT) analysis set. The ITT consists of all participants who have been randomized and received at least one dose of glatiramer acetate or placebo.||days||95% Confidence Interval|Number
764713|NCT00666224|Secondary|Percentage Change in Brain Volume From Baseline to the Last Observed Value (LOV) During the Double-blind Period Using the Structural Image Evaluation of Normalized Atrophy (SIENA) Technique|Data from interim analysis with database lock on October 14, 2007. Brain volume was measured annually by magnetic resonance imaging (MRI) during the Double-blind period. Brain atrophy was measured by comparing the change in brain volume from baseline to the Last Observed Value (LOV). LOV is defined as the last post baseline measurement taken on study drug but no more than 30 days after study drug cessation. SIENA is a fully automated method of analyzing longitudinal brain change.|Day 0 (baseline), up to 3 years|Intent to treat population of participants with both baseline and last observed values.||percent change||Standard Deviation|Mean
764714|NCT00666224|Secondary|Change From Baseline to Last Observed Value (LOV) in T2 Brain Lesion Volume in the Double-blind Period|Data from interim analysis with database lock on October 14, 2007. The difference in T2 brain lesion volume as observed in MRIs from baseline to the last observed value. Last Observed Value (LOV) is defined as the last post baseline measurement taken on study drug but no more than 30 days after study drug cessation.|Day 0 (baseline), up to 3 years|Intent to treat population for which data at both timepoints are available||ml||Standard Deviation|Mean
764715|NCT00666224|Secondary|Number of New T2 Brain Lesions Observed at the Last Observed Value (LOV) in the Double-blind Period|Data from interim analysis with database lock on October 14, 2007. T2 lesions are brain lesions that show on magnetic resonance imaging (MRI) and are associated with multiple sclerosis. This outcome measures the number of new lesions at the last observed value. Last Observed Value (LOV) is defined as the last post baseline measurement taken on study drug but no more than 30 days after study drug cessation.|up to 3 years|Intent-to-Treat (ITT) analysis set. The ITT consists of all participants who have been randomized and received at least one dose of glatiramer acetate or placebo.||new T2 lesions||Standard Deviation|Mean
764716|NCT00666224|Primary|Time to Clinically Definite Multiple Sclerosis (CDMS) Conversion|Data from interim analysis with database lock on October 14, 2007. The time from randomization to conversion to CDMS as determined by the occurrence of a second clinical attack during the double-blind period. Poser criteria are: Two relapses and clinical evidence of two separate lesions; clinical evidence of one lesion and paraclinical evidence of another separate lesion. The two relapses must involve different parts of Central Nervous System and must be separated by a period of at least one month. Lesions are determined by Magnetic Resonance Imaging (MRI).|up to 3 years|Intent-to-Treat (ITT) analysis set. The ITT consists of all participants who have been randomized and received at least one dose of glatiramer acetate or placebo.||days||Standard Deviation|Mean
764717|NCT00666263|Primary|The Percentage of Participants Reporting One or More Moderate or Severe AEs That Began During Infusion or Within 72 Hours of Completion of an Infusion||Within 72 hours of completion of an infusion during the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)|Safety Dataset||percentage of participants|||Number
764718|NCT00666263|Secondary|The Proportion of Infusions Associated With One or More AEs Related to the Study Product||Throughout the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)|Safety Dataset||proportion of infusions|Participants||Number
764719|NCT00666263|Secondary|The Proportion of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped for Tolerability Concerns/AEs||Throughout the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)|Safety Dataset||proportion of infusions|Participants||Number
764720|NCT00666263|Secondary|The Proportion of Participants for Whom the Infusion Rate of Any Infusion Was Reduced and/or the Infusion Was Interrupted or Stopped for Tolerability Concerns/AEs||Throughout the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)|Safety Dataset||proportion of participants|||Number
764721|NCT00666263|Secondary|Rate of Related SAEs Per Infusion|The total number of SAEs determined by the investigator to be related to the study product that occur at any time during the study divided by the total number of infusions, and multiplied by 100.|Throughout the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)|Safety Dataset||SAEs per infusion|Participants||Number
764722|NCT00666263|Secondary|Rate of Related AEs Per Infusion|The total number of AEs determined by the investigator to be related to the study product that occur at any time during the study divided by the total number of infusions, and multiplied by 100.|Throughout the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)|Safety Dataset||AEs per infusion|Participants||Number
764723|NCT00666263|Primary|The Percentage of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped for Any Reason||Throughout the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)|Safety Dataset||percentage of infusions|Participants||Number
764724|NCT00666263|Primary|The Percentage of Participants for Whom the Infusion Rate of Any Infusion Was Reduced and/or the Infusion Was Interrupted or Stopped for Any Reason||Throughout the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)|Safety Dataset||percentage of participants|||Number
764725|NCT00666263|Primary|Rate of Temporally Associated Adverse Events (AEs) Per Infusion|The total number of all AEs which begin during or within 72 hours of completion of an infusion, irrespective of being related or not related to the study product (IGIV, 10% or Placebo), divided by the total number of infusions, and multiplied by 100.|Within 72 hours of completion of an infusion during the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)|Safety Dataset||Percentage of AEs per infusion|Participants||Number
764726|NCT00666263|Primary|Co-Primary Endpoint: Proportion of Participants With Deterioration in Guy’s Neurological Disability Score (GNDS)|GNDS (based on Sharrack and Hughes, 1999) for the upper limbs were integers 0 to 5, with 0 indicating no impairment.|Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)|Intent to treat||Proportion of participants|||Number
764727|NCT00666263|Post-Hoc|Proportion of Participants With at Least a 30% Decline in Relative Grip Strength in the Less Affected Hand (Measured Using a DynEx Digital Dynamometer)|"Relative grip strength change is defined as 100 * (End of the Cross-Over Period - baseline of Cross-Over Period) divided by baseline of Cross-Over Period.
The grip strength was measured using a DynEx digital dynamometer. The result of grip strength was recorded to a resolution of 0.1 kg. For statistical analysis, the mean of (usually three) trials for cross-over sessions 1 and 2 was computed and the mean of the sessions was used in the analysis as the result of the grip strength measurement. Only if no grip strength testing could be performed the results were considered as missing."|Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)|Intent to treat||Proportion of participants|||Number
764728|NCT00666263|Primary|Co-Primary Endpoint: Guy's Neurologic Disability Scale (GNDS) for Upper Limbs|GNDS (based on Sharrack and Hughes, 1999) for the upper limbs were integers 0 to 5, with 0 indicating no impairment.|Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit|Intent to treat||Scores on a scale||Inter-Quartile Range|Median
764749|NCT00666276|Primary|Factors Considered to Affect the Safety of Linezolid - Duration of Drug Administration.|Number of participants with Duration of drug administration as over 15 days or less than 15 days with adverse drug reaction to determine whether over 15 days or less than 15 days is significant risk factor.|8 weeks|Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.||participants|||Number
764729|NCT00666263|Secondary|Mean Relative Change in Participants' Assessment of Physical Functioning on a Visual Analog Scale (VAS)|"Relative Change is defined as 100 * (End of the Cross-Over Period - baseline of Cross-Over Period) divided by baseline of Cross-Over Period.
The VAS measured patients’ assessment of physical functioning on a 10 centimeter scale of 0-10, on which 0 represents “no symptoms” and 10 “disabled, unable to use affected limbs”."|Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)|Intent to treat||Percent change in assessment||95% Confidence Interval|Mean
764730|NCT00666263|Secondary|Participants' Assessment of Physical Functioning on a Visual Analog Scale (VAS)|The VAS measured patients’ assessment of physical functioning on a 10 centimeter scale of 0-10, on which 0 represents “no symptoms” and 10 “disabled, unable to use affected limbs”.|Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit|Intent to treat||Scores on a scale||Inter-Quartile Range|Median
764731|NCT00666263|Secondary|Mean Relative Change in Time Required by Participants to Complete the 9 Hole Peg Board Test (9-HPT) With the Non-Dominant Hand|"Relative Change is defined as 100 * (End of the Cross-Over Period - baseline of Cross-Over Period) divided by baseline of Cross-Over Period.
The 9-HPT is a quantitative measure of upper extremity (arm and hand) function. Participants picked up the pegs one at a time (nine in total), and put them into the holes on the board as quickly as possible, in any order until all the holes were filled. Then, without pausing, participants removed the pegs one at a time and returned them to the container as quickly as possible. Each participant did this two times with their non-dominant hand. The 9-HCT objective is to see how fast participants could put all of the pegs in and take them out again."|Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)|Intent to treat||Percent change in time||95% Confidence Interval|Mean
764732|NCT00666263|Secondary|Time Required by Participants to Complete the 9 Hole Peg Board Test (9-HPT) With the Non-Dominant Hand|The 9-HPT is a quantitative measure of upper extremity (arm and hand) function. Participants picked up the pegs one at a time (nine in total), and put them into the holes on the board as quickly as possible, in any order until all the holes were filled. Then, without pausing, participants removed the pegs one at a time and returned them to the container as quickly as possible. Each participant did this two times with their non-dominant hand. The 9-HCT objective is to see how fast participants could put all of the pegs in and take them out again.|Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit|Intent to treat||Seconds||Inter-Quartile Range|Median
764733|NCT00666263|Secondary|Mean Relative Change in Time Required by Participants to Complete the 9 Hole Peg Board Test (9-HPT) With the Dominant Hand|"Relative Change is defined as 100 * (End of the Cross-Over Period - baseline of Cross-Over Period) divided by baseline of Cross-Over Period.
The 9-HPT is a quantitative measure of upper extremity (arm and hand) function. Participants picked up the pegs one at a time (nine in total), and put them into the holes on the board as quickly as possible, in any order until all the holes were filled. Then, without pausing, participants removed the pegs one at a time and returned them to the container as quickly as possible. Each participant did this two times with their dominant hand. The 9-HCT objective is to see how fast participants could put all of the pegs in and take them out again."|Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)|Intent to treat||Percent change in time||95% Confidence Interval|Mean
764734|NCT00666263|Secondary|Time Required by Participants to Complete the 9 Hole Peg Board Test (9-HPT) With the Dominant Hand|The 9-HPT is a quantitative measure of upper extremity (arm and hand) function. Participants picked up the pegs one at a time (nine in total), and put them into the holes on the board as quickly as possible, in any order until all the holes were filled. Then, without pausing, participants removed the pegs one at a time and returned them to the container as quickly as possible. Each participant did this two times with their dominant hand. The 9-HCT objective is to see how fast participants could put all of the pegs in and take them out again.|Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit|Intent to treat||Seconds||Inter-Quartile Range|Median
764735|NCT00666263|Secondary|Mean Relative Change in Overall Disability Sum Score|"Relative Change is defined as 100 * (End of the Cross-Over Period - baseline of Cross-Over Period) divided by baseline of Cross-Over Period.
The overall disability sum scale (based on Merkies et al., 2002) is a patient questionnaire that measures disability (from 0, “no signs of disability” to 12, “most severe disability”). This was standardized to a scale of 0 to 100 (the best score being 100) to allow calculation of relative changes."|Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)|Intent to treat||percent change in score||95% Confidence Interval|Mean
764736|NCT00666263|Secondary|Overall Disability Sum Score - Standardized|"The overall disability sum scale (based on Merkies et al., 2002) is a patient questionnaire that measures disability. Overall disability sum score = arm disability scale (range 0–5) + leg disability scale (range 0–7); Overall Range: 0 (no signs of disability) to 12 (maximum disability).
This was standardized to a scale of 0 to 100 (the best score being 100) to allow calculation of relative changes."|Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit|Intent to treat||Scores on a scale||Inter-Quartile Range|Median
764737|NCT00666263|Secondary|Overall Disability Sum Score|"The overall disability sum scale (based on Merkies et al., 2002) is a patient questionnaire that measures disability.
Overall disability sum score = arm disability scale (range 0–5) + leg disability scale (range 0–7); Overall Range: 0 (no signs of disability) to 12 (maximum disability)."|Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit|Intent to treat||Scores on a scale||Inter-Quartile Range|Median
765302|NCT00670241|Secondary|Subjects With Rebound During the Study||Week 8-16|||participants|||Number
764738|NCT00666263|Secondary|Patient Global Impression of Change|"Patient Global Impression of Change was measured on an ordinal scale of 1-7, higher scores representing greater perceived deterioration since the previous efficacy assessment (ranging from (1) very much improved to very much worse (7)).
Very much improved
Much improved
Minimally improved
No change
Minimally worse
Much worse
Very much worse"|Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit|Intent to treat||Scores on a scale||Inter-Quartile Range|Median
764739|NCT00666263|Secondary|Proportion of Participants That Were Accelerated Forward Into the Next Stabilization Phase (ie Switched to Open-Label IGIV, 10%)|Participants were permitted to switch from blinded treatment with placebo or IGIV, 10% to open label IGIV, 10% if they and investigator agreed that deterioration had occurred to the extent that the participant had unacceptable difficulty carrying out daily activities involving the affected muscles, or decline in grip strength of ≥50% in the more affected hand had occurred.|During the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)|Intent to treat||Proportion of participants|||Number
764740|NCT00666263|Secondary|Mean Relative Change in Grip Strength in the Less Affected Hand|"Relative Change is defined as 100 * (End of the Cross-Over Period - Baseline of Cross-Over Period) divided by baseline of Cross-Over Period.
The grip strength was measured using a DynEx digital dynamometer. The result of grip strength was recorded to a resolution of 0.1 kg. For statistical analysis, the mean of (usually three) trials for cross-over sessions 1 and 2 was computed and the mean of the sessions was used in the analysis as the result of the grip strength measurement. Only if no grip strength testing could be performed the results were considered as missing."|Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)|Intent to treat||Percent change in grip strength||95% Confidence Interval|Mean
764741|NCT00666263|Secondary|Grip Strength in the Less Affected Hand|"The grip strength was measured using a DynEx digital dynamometer. The result of grip strength was recorded to a resolution of 0.1 kg.
Each grip strength test consisted of 3 maximal repeated contractions (trials). Each participant will perform 2 sessions of grip strength testing. After a 10-minute break, the testing session will be repeated for a total of 6 grip repetitions per hand."|Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit|Intent to treat||kilograms||Inter-Quartile Range|Median
764742|NCT00666263|Secondary|Percentage of Participants With at Least a 30% Decline in Relative Grip Strength in the More Affected Hand (Measured Using a DynEx Digital Dynamometer)|"Relative grip strength change is defined as 100 * (End of the Cross-Over Period - baseline of Cross-Over Period) divided by baseline of Cross-Over Period.
The grip strength was measured using a DynEx digital dynamometer. The result of grip strength was recorded to a resolution of 0.1 kg. For statistical analysis, the mean of (usually three) trials for cross-over sessions 1 and 2 was computed and the mean of the sessions was used in the analysis as the result of the grip strength measurement. Only if no grip strength testing could be performed the results were considered as missing."|Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)|Intent to treat||Percentage of participants|||Number
764743|NCT00666263|Primary|Mean Relative Change in Grip Strength in the More Affected Hand|"Relative Change is defined as 100 * (End of the Cross-Over Period - baseline of Cross-Over Period) divided by baseline of Cross-Over Period.
The grip strength was measured using a DynEx digital dynamometer. The result of grip strength was recorded to a resolution of 0.1 kg. For statistical analysis, the mean of (usually three) trials for cross-over sessions 1 and 2 was computed and the mean of the sessions was used in the analysis as the result of the grip strength measurement. Only if no grip strength testing could be performed the results were considered as missing."|Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)|Intent to treat||Percent change in grip strength||95% Confidence Interval|Mean
764744|NCT00666263|Primary|Grip Strength in the More Affected Hand|"The grip strength was measured using a DynEx digital dynamometer. The result of grip strength was recorded to a resolution of 0.1 kg.
Each grip strength test consisted of 3 maximal repeated contractions (trials). Each participant will perform 2 sessions of grip strength testing. After a 10-minute break, the testing session will be repeated for a total of 6 grip repetitions per hand."|Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit|Intent to treat||kilograms||Inter-Quartile Range|Median
764745|NCT00666276|Primary|Factors Considered to Affect the Safety of Linezolid - Non-drug Therapies.|Number of participants with or without Non-drug therapies with adverse drug reaction to determine whether with or without is significant risk factor.|8 weeks|Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.||participants|||Number
764746|NCT00666276|Primary|Factors Considered to Affect the Safety of Linezolid - Concomitant Drugs.|Number of participants with or without Concomitant drugs with adverse drug reaction to determine whether with or without is significant risk factor.|8 weeks|Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.||participants|||Number
764747|NCT00666276|Primary|Factors Considered to Affect the Safety of Linezolid - Weight.|Number of participants Weight as over 40kg or less than 40kg with adverse drug reaction to determine whether over 40kg or less than 40kg Weight is significant risk factor.|8 weeks|Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.||participants|||Number
764748|NCT00666276|Primary|Factors Considered to Affect the Safety of Linezolid - Route of Administration.|Number of participants Route of administration as by oral,injection or oral from injection with adverse drug reaction to determine whether oral, injection or switch is significant risk factor.|8 weeks|Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.||participants|||Number
769118|NCT00709124|Secondary|Lower Extremity Strength, at Hospital Discharge, of 3 Bilateral Muscle Groups (Pretibial, Triceps Surae, and Quadriceps) Measured Via MMT Using a Composite Medical Research Council (MRC) Score||At ICU discharge||||||
764750|NCT00666276|Primary|Factors Considered to Affect the Safety of Linezolid - Renal Dysfunctions.|Number of participants with or without Renal dysfunctions with adverse drug reaction to determine whether with or without is significant risk factor.|8 weeks|Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.||participants|||Number
764751|NCT00666276|Primary|Factors Considered to Affect the Safety of Linezolid - Hepatic Dysfunctions.|Number of participants with or without Hepatic dysfunctions with adverse drug reaction to determine whether with or without is significant risk factor.|8 weeks|Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.||participants|||Number
764752|NCT00666276|Primary|Factors Considered to Affect the Safety of Linezolid - Age|Number of participants with adverse drug reaction to determine whether over 65 or less than 65 is significant risk factor.|8 weeks|Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.||participants|||Number
764753|NCT00666276|Primary|Factors Considered to Affect the Safety of Linezolid - Gender.|Number of participants with adverse drug reaction to determine whether male or female is significant risk factor.|8 weeks|Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.||participants|||Number
764754|NCT00666276|Primary|Number of Participants With Adverse Drug Reactions(ADRs).|All observed or volunteered adverse events and the investigator’s opinion of the causal relationship to the study treatment were reported. Adverse Drug Reactions were evaluated in company with the causal relationship to the investigational product.|8 weeks|Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.||participants|||Number
764755|NCT00666276|Primary|Number of Participants With Adverse Drug Reaction Not Expected From the Japanese Package Insert.|The adverse drug reaction that have not been listed in Japanese package insert.|Baseline to 8 weeks|Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.||participants|||Number
764756|NCT00666328|Secondary|The Percentage of Patients Whose Systolic Blood Pressure is <90 mmHg Within 30 Minutes of the Initiation of Clevidipine Infusion||Within 30 minutes of the initiation of study drug infusion|The Safety population is defined as all enrolled patients who are dosed with clevidipine. This population serves as the primary population for the safety analyses.||percent participants|||Number
764757|NCT00666328|Secondary|Percent Change in Heart Rate During 30 of Initiation of Clevidipine|Multiple timepoints were assessed (minutes 1, 2, 3, 4, 5, 10, 15, 20, 30) for analysis of percent change in heart rate during the initial 30 minutes.|From study drug initiation through each specified timepoint|The Safety population is defined as all enrolled patients who are dosed with clevidipine. This population serves as the primary population for the safety analyses. Data for 33 of the 35 patients in the Safety population had data for the 30 minute time point used for this analysis.||percent change||Standard Deviation|Mean
764758|NCT00666328|Secondary|Proportion of Patients Requiring an Additional or Alternative Antihypertensive Agent(s) With or Without Clevidipine|Additional or alternative antihypertensive agent(s) comprise the use of other antihypertensive agent(s) either with clevidipine (additional) or in place of clevidipine (alternative) for the indication of hypertension from the time of clevidipine initiation to clevidipine termination. For purposes of this analysis, additional or alternative antihypertensive agents did not include oral antihypertensives that were administered in order to transition IV clevidipine-treated patients to oral therapy during the transition period of the study.|Up to 96 hours|The Modified Intent-to-Treat (mITT) population, defined as all enrolled patients who are eligible for the study (i.e., meet all the inclusion criteria and do not meet any of the exclusion criteria) and treated with clevidipine infusion, population will be the primary population for the efficacy analyses.||participants|||Number
764759|NCT00666328|Secondary|Median Dose of Clevidipine During the Treatment Period|Mean total dose of clevidipine from study drug initiation to the end of clevidipine treatment|Up to 96 hours|||milligrams (mg)||Inter-Quartile Range|Median
764760|NCT00666328|Secondary|Mean Dose of Clevidipine During the Treatment Period|Mean total dose of clevidipine from study drug initiation to the end of clevidipine treatment|Up to 96 hours|The Safety population is defined as all enrolled patients who are dosed with clevidipine. This population serves as the primary population for the safety analyses.||milligrams (mg)||Standard Deviation|Mean
764761|NCT00666328|Secondary|Percent Time Blood Pressures Were Maintained Within the Target Range (Systolic Blood Pressure ≤160 mmHg to ≥140 mmHg) Over Each 24 Hour Period During Monotherapy Infusion of Clevidipine|The percent time that SBP was maintained within the SBP target range (≤160 mmHg to ≥140 mmHg) was summarized for each 24-hour period of monotherapy of clevidipine infusion through 96 hours (0 -≤24 h, 24-≤48 h, 48-≤72 h, 72-≤96 h). For purposes of this analysis, SBP data were available from all mITT patients for the overall infusion period and from 0 to ≤24 hours of infusion; however, data was only available for 8 patients from 24 to ≤48 hours, 4 patients from 48 to ≤72 hours and 1 patient from 72 to ≤96 hours due to the variability in infusion durations >24 hours across patients.|From study drug initiation through termination (up to 96 h)|The Modified Intent-to-Treat (mITT) population, defined as all enrolled patients who are eligible for the study (i.e., meet all the inclusion criteria and do not meet any of the exclusion criteria) and treated with clevidipine infusion, population will be the primary population for the efficacy analyses.||percent time||Standard Deviation|Mean
764762|NCT00666328|Secondary|Magnitude, Frequency and Duration of Systolic Blood Pressure Excursions (Calculated as Area Under the Curve [AUC]) Outside the Target Range Normalized Per Hour for the Duration of the Clevidipine Monotherapy Infusion|Total AUC-SBP captures the magnitude and duration of SBP either above the upper limit of the target SBP range at 160 mm Hg or below the lower limit of 140 mm Hg and normalized per hour for the duration of clevidipine infusion. A larger value for AUC-SBP indicates greater SBP variability outside the target range.|Duration of the study drug infusion (up to 96 hours)|||mm Hg × min/hr||Standard Deviation|Mean
764779|NCT00666406|Secondary|Incremental Recovery. FVIII One-Stage Clotting Assay (Bonn Method) Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|Increase in factor VIII concentration from pre- to post-infusion|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||(IU/dL)/(IU/kg)||90% Confidence Interval|Geometric Mean
764763|NCT00666328|Secondary|Percent Change From Baseline in Systolic Blood Pressure During the Initial 30 Minutes of Clevidipine Infusion|Over the initial 30 minutes of the treatment period, the percent change from baseline (defined as immediately prior to study drug initiation) was summarized descriptively at 1, 2, 3, 4, 5, 6, 7, 10, 15, 20, 25, and 30 minutes after clevidipine initiation. Decreases in SBP from baseline were observed over the course of this time period.|Baseline through 30 minutes post initiation of clevidipine infusion|||percent change in SBP||Standard Deviation|Mean
764764|NCT00666328|Secondary|Percentage of Participants Achieving a SBP of ≤160 mmHg Within 30 Minutes of Initiation of Clevidipine|The percentage of patients who reached SBP of ≤160 mmHg within the first 30 minutes of initiation of clevidipine infusion was summarized. If an additional or alternative IV antihypertensive agent and/or oral antihypertensive agent was administered for hypertension prior to a patient achieving SBP≤160 mmHg during the initial 30-minute treatment period, then the patient was considered to have failed to reach this efficacy endpoint.|Within 30 minutes of study drug initiation|Modified Intent To Treat (mITT) population: all participants dosed with clevidipine and in whom all inclusion criteria and none of the exclusion criteria were met.||percent participants||95% Confidence Interval|Number
764765|NCT00666328|Primary|Median Time to Achieve Target SBP Range (≤160 mmHg to ≥140 mmHg) Within 30 Minutes of Initiation of Clevidipine|The median time, in minutes, was estimated with its two-tailed 95% confidence interval from the time of the initiation of clevidipine infusion until the first observed SBP was achieved in the target range of ≤160 mmHg to ≥140 mmHg within the first 30 minutes of clevidipine treatment. If patients did not reach the blood pressure target range within the first 30 minutes, their data was considered censored at 30 minutes. If another IV and/or oral antihypertensive agent indicated for hypertension was administered less than 30 minutes prior to achieving the endpoint, the data was considered censored at the time when the additional or alternative antihypertensive agent was given.|Within 30 minutes of study drug initiation|Modified Intent To Treat (mITT) population: all participants dosed with clevidipine and in whom all inclusion criteria and none of the exclusion criteria were met.||minutes||95% Confidence Interval|Median
764766|NCT00666406|Secondary|Volume of Distribution at Steady State (Vss). FVIII Clotting Assay. Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|Computed as weight-adjusted CL * Mean Residence Time|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||mL/kg||90% Confidence Interval|Geometric Mean
764767|NCT00666406|Secondary|Volume of Distribution at Steady State (Vss). FVIII One-Stage Clotting Assay (Bonn Method) Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|Computed as weight-adjusted CL * Mean Residence Time|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||mL/kg||90% Confidence Interval|Geometric Mean
764768|NCT00666406|Secondary|Volume of Distribution at Steady State (Vss). Chromogenic Assay Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|Computed as weight-adjusted Clearance (CL) * Mean Residence Time|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||mL/kg||90% Confidence Interval|Geometric Mean
764769|NCT00666406|Secondary|Volume of Distribution at Steady State (Vss). One-Stage aPTT-Based Assay Performed at Central Laboratory (Medical University Vienna)|Computed as weight-adjusted Clearance * Mean Residence Time|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||mL/kg||90% Confidence Interval|Geometric Mean
764770|NCT00666406|Secondary|Time to Reach the Maximum Plasma Concentration (Tmax). FVIII Clotting Assay. Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|Tmax in hours was defined as the minimum time to reach Maximum plasma concentration (Cmax).|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||Hours||90% Confidence Interval|Geometric Mean
764771|NCT00666406|Secondary|Time to Reach the Maximum Plasma Concentration (Tmax). FVIII One-Stage Clotting Assay (Bonn Method) Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|Tmax in hours was defined as the minimum time to reach Maximum plasma concentration (Cmax).|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||Hours||90% Confidence Interval|Geometric Mean
764772|NCT00666406|Secondary|Time to Reach the Maximum Plasma Concentration (Tmax). Chromogenic Assay Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|Tmax in hours was defined as the minimum time to reach Maximum plasma concentration (Cmax).|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||Hours||90% Confidence Interval|Geometric Mean
764773|NCT00666406|Secondary|Time to Reach the Maximum Plasma Concentration (Tmax). One-Stage aPTT-Based Assay Performed at Central Laboratory (Medical University Vienna)|Tmax in hours was defined as the minimum time to reach Maximum plasma concentration (Cmax).|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||Hours||90% Confidence Interval|Geometric Mean
764774|NCT00666406|Secondary|Mean Residence Time (MRT). FVIII Clotting Assay. Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|The MRT in hours will be calculated as total area under the moment curve divided by the total area under the curve.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||Hours||90% Confidence Interval|Geometric Mean
764775|NCT00666406|Secondary|Mean Residence Time (MRT). FVIII One-Stage Clotting Assay (Bonn Method) Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|The MRT in hours will be calculated as total area under the moment curve divided by the total area under the curve.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||Hours||90% Confidence Interval|Geometric Mean
764776|NCT00666406|Secondary|Mean Residence Time (MRT). Chromogenic Assay Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|The MRT in hours will be calculated as total area under the moment curve divided by the total area under the curve.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||Hours||90% Confidence Interval|Geometric Mean
764777|NCT00666406|Secondary|Mean Residence Time (MRT). One-Stage aPTT-Based Assay Performed at Central Laboratory (Medical University Vienna)|The MRT in hours will be calculated as total area under the moment curve divided by the total area under the curve.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||Hours||90% Confidence Interval|Geometric Mean
764778|NCT00666406|Secondary|Incremental Recovery. FVIII Clotting Assay. Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|Increase in factor VIII concentration from pre- to post-infusion|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||(IU/dL)/(IU/kg)||90% Confidence Interval|Geometric Mean
764780|NCT00666406|Secondary|Incremental Recovery. Chromogenic Assay Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|Computed from the terminal or disposition rate constant obtained from log_e -linear fitting using the least squares deviation to the last five quantifiable concentrations.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||(IU/dL)/(IU/kg)||90% Confidence Interval|Geometric Mean
764781|NCT00666406|Secondary|Incremental Recovery. One-Stage aPTT-Based Assay Performed at Central Laboratory (Medical University Vienna)|Increase in factor VIII concentration from pre- to post-infusion.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||(IU/dL)/(IU/kg)||90% Confidence Interval|Geometric Mean
764782|NCT00666406|Secondary|Terminal Half-life. FVIII Clotting Assay. Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|Computed from the terminal or disposition rate constant obtained from log-linear fitting using the least squares deviation to the last five quantifiable concentrations.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||hours||90% Confidence Interval|Geometric Mean
764783|NCT00666406|Secondary|Terminal Half-life. FVIII One-Stage Clotting Assay (Bonn Method) Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|Computed from the terminal or disposition rate constant obtained from log-linear fitting using the least squares deviation to the last five quantifiable concentrations.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||hours||90% Confidence Interval|Geometric Mean
764784|NCT00666406|Secondary|Terminal Half-life. Chromogenic Assay Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|Computed from the terminal or disposition rate constant obtained from log-linear fitting using the least squares deviation to the last five quantifiable concentrations.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||hours||90% Confidence Interval|Geometric Mean
764785|NCT00666406|Secondary|Terminal Half-life. One-Stage aPTT-Based Assay Performed at Central Laboratory (Medical University Vienna)|Computed from the terminal or disposition rate constant obtained from log-linear fitting using the least squares deviation to the last five quantifiable concentrations (9 to 48 hours).|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||hours||90% Confidence Interval|Geometric Mean
764786|NCT00666406|Secondary|Maximum Plasma Concentration (C-max). FVIII Clotting Assay. Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|C-max will be calculated as the maximum concentration following infusion of either Advate or Recombinate.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||IU/dL||90% Confidence Interval|Geometric Mean
764787|NCT00666406|Secondary|Maximum Plasma Concentration (C-max). FVIII One-Stage Clotting Assay (Bonn Method) Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|C-max will be calculated as the maximum concentration following infusion of either Advate or Recombinate.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||IU/dL||90% Confidence Interval|Geometric Mean
764788|NCT00666406|Secondary|Maximum Plasma Concentration (C-max). Chromogenic Assay Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|C-max will be calculated as the maximum concentration following infusion of either Advate or Recombinate.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||IU/dL||90% Confidence Interval|Geometric Mean
764789|NCT00666406|Secondary|Maximum Plasma Concentration (C-max). One-Stage aPTT-Based Assay Performed at Central Laboratory (Medical University Vienna)|C-max will be calculated as the maximum concentration following infusion of either Advate or Recombinate.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||IU/dL||90% Confidence Interval|Geometric Mean
764790|NCT00666406|Secondary|Systemic Clearance (Cl). FVIII Clotting Assay. Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|Systemic clearance in mL/kg/h will be calculated as the dose in IU/kg divided by the total area under the curve.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||mL/h/kg||90% Confidence Interval|Geometric Mean
764791|NCT00666406|Secondary|Systemic Clearance (Cl). FVIII One-Stage Clotting Assay (Bonn Method) Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|Systemic clearance in mL/kg/h will be calculated as the dose in IU/kg divided by the total area under the curve.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||mL/h/kg||90% Confidence Interval|Geometric Mean
764792|NCT00666406|Secondary|Systemic Clearance (Cl). Chromogenic Assay Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|Systemic clearance in mL/kg/h will be calculated as the dose in IU/kg divided by the total area under the curve.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||mL/h/kg||90% Confidence Interval|Geometric Mean
764793|NCT00666406|Secondary|Systemic Clearance (Cl). One-Stage aPTT-Based Assay Performed at Central Laboratory (Medical University Vienna)|Systemic clearance in mL/kg/h will be calculated as the dose in IU/kg divided by the total area under the curve.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||mL/h/kg||90% Confidence Interval|Geometric Mean
764794|NCT00666406|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC) From 0 to Infinity. FVIII Clotting Assay. Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|AUC estimated by linear trapezoidal method. The linear trapezoidal method is a numerical method used to approximate the area under a curve.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||IU*h/dL||90% Confidence Interval|Geometric Mean
764795|NCT00666406|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC) From 0 to Infinity. FVIII One-Stage Clotting Assay (Bonn Method) Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|AUC estimated by linear trapezoidal method. The linear trapezoidal method is a numerical method used to approximate the area under a curve.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||IU*h/dL||90% Confidence Interval|Geometric Mean
764796|NCT00666406|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC) From 0 to Infinity. Chromogenic Assay Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|AUC estimated by linear trapezoidal method. The linear trapezoidal method is a numerical method used to approximate the area under a curve.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||IU*h/dL||90% Confidence Interval|Geometric Mean
765303|NCT00670241|Secondary|Subjects With Relapse During the Study|Among subjects with controlled disease at week 8 relapse was defined as PASI exceeding the baseline PASI value minus 50% of the reduction in PASI obtained from the baseline visit to the last on-treatment visit|Week 8-16|||participants|||Number
764797|NCT00666406|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC) From 0 to Infinity. One-Stage aPTT-Based Assay Performed at Central Laboratory (Medical University Vienna)|"AUC estimated by linear trapezoidal method. The linear trapezoidal method is a numerical method used to approximate the area under a curve.
FVIII activity measurement"|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||IU*h/dL||90% Confidence Interval|Geometric Mean
764798|NCT00666406|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) From 0 to 48 Hours. FVIII Clotting Assay. Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|AUC estimated by linear trapezoidal method. The linear trapezoidal method is a numerical method used to approximate the area under a curve.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||IU*h/dL||90% Confidence Interval|Geometric Mean
764799|NCT00666406|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) From 0 to 48 Hours. FVIII One-Stage Clotting Assay (Bonn Method) Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|AUC estimated by linear trapezoidal method. The linear trapezoidal method is a numerical method used to approximate the area under a curve.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||IU*h/dL||90% Confidence Interval|Geometric Mean
764800|NCT00666406|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) From 0 to 48 Hours. Chromogenic Assay Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|AUC estimated by linear trapezoidal method. The linear trapezoidal method is a numerical method used to approximate the area under a curve.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||IU*h/dL||90% Confidence Interval|Geometric Mean
764801|NCT00666406|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) From 0 to 48 Hours. One-Stage Activated Partial Thromboplastin Time (aPTT) -Based Assay Performed at Central Laboratory (Medical University Vienna)|AUC estimated by linear trapezoidal method. The linear trapezoidal method is a numerical method used to approximate the area under a curve.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||IU*h/dL||90% Confidence Interval|Geometric Mean
764802|NCT00666458|Secondary|Fasting Plasma Glucose Change From Baseline to Week 18 (mmol/L)|Adjusted mean change from baseline in Fasting Plasma Glucose achieved with saxagliptin added on to metformin versus sitagliptin added on to metformin at Week 18 (Full Analysis Set). Fasting Plasma Glucose is a continuous measure, the change from baseline for each participant is calculated as the Week 18 (LOCF) value minus the baseline value.|Baseline, Week 18 (Last Observation Carried Forward)|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 18 LOCF, participants must have had a baseline and at least 1 post-baseline measurement.||mmol/L||Standard Error|Mean
764803|NCT00666458|Secondary|Fasting Plasma Glucose Change From Baseline to Week 18 (mg/dL)|Adjusted mean change from baseline in Fasting Plasma Glucose achieved with saxagliptin added on to metformin versus sitagliptin added on to metformin at Week 18 (Full Analysis Set). Fasting Plasma Glucose is a continuous measure, the change from baseline for each participant is calculated as the Week 18 (LOCF) value minus the baseline value.|Baseline, Week 18 (Last Observation Carried Forward)|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 18 LOCF, participants must have had a baseline and at least 1 post-baseline measurement.||mg/dL||Standard Error|Mean
764804|NCT00666458|Secondary|Proportion of Patients Achieving Therapeutic Glycaemic Response Defined as HbA1c <= 6.5% at Week 18|Proportion of Patients Achieving Therapeutic Glycaemic Response Defined as HbA1c <= 6.5% at Week 18 (Full Analysis Set)|Week 18 (Last Observation Carried Forward)|Randomized participants who took at least 1 dose of double-blind treatment. To be included in the Week 18 LOCF analysis, participants must have had a baseline and at least 1 post-baseline measurement.||Percentage of Participants|||Number
764805|NCT00666458|Primary|Hemoglobin A1c (HbA1c) Change From Baseline to Week 18|Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus sitagliptin added on to metformin at Week 18 (Per Protocol Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 18 value minus the baseline value.|Baseline, Week 18|Randomized participants who completed the 18 weeks of treatment had both baseline and week 18 HbA1c measurement and had no significant protocol deviations.||Percent||Standard Error|Mean
764806|NCT00666536|Secondary|Percentage of Patients Achieving BP Goal of MSSBP < 140mmHg at Weeks 2, 4, 8 and 12||Weeks 2, 4, 8 and 12|Intent to treat (ITT), Last observation carried forward (LOCF)||Percentage of Patients|||Number
764807|NCT00666536|Secondary|Change From Baseline to Weeks 2, 8 and 12 in MSDBP||Baseline and Weeks 2, 8 and 12|Intent to treat (ITT), Last observation carried forward (LOCF)||mmHg||Standard Deviation|Mean
764808|NCT00666536|Secondary|Change From Baseline to Weeks 2, 8 and 12 in MSSBP||Baseline and Weeks 2, 8 and 12|Intent to treat (ITT), Last observation carried forward (LOCF)||mmHg||Standard Deviation|Mean
764809|NCT00666536|Secondary|Change From Baseline to Week 4 in Mean Sitting Diastolic Blood Pressure (MSDBP)||Baseline and Week 4|Intent to treat (ITT), Last observation carried forward (LOCF)||mmHg||Standard Deviation|Mean
764810|NCT00666536|Secondary|Percentage of Patients Achieving the Blood Pressure (BP) Goal of < 140/90 mmHg at Weeks 2,4,8 and 12||Weeks 2, 4, 8 and 12|Intent to treat (ITT), Last observation carried forward (LOCF)||Percentage of Patients|||Number
764811|NCT00666536|Primary|Change From Baseline to Week 4 in Mean Sitting Systolic Blood Pressure (MSSBP)||Baseline and Week 4|Intent to treat (ITT), Last observation carried forward (LOCF)||mmHg||Standard Deviation|Mean
764812|NCT00666562|Secondary|Metabolism of EGCG in Serum and Urine in Relation to Pharmacogenetic Polymorphisms in Uridinediphosphate- Glucuronosyltransferase (UGT)||At Baseline|This outcome was assessed in all participants,combined irrespective of their randomization. Analysis was not able to be completed for 4 participants.||ng/mL||Standard Deviation|Mean
764813|NCT00666562|Secondary|Absolute Change for Baseline of EGCG in Urine Samples|The difference between the amount at the end of study (up to 28 days) from baseline.|Baseline and up to 28 days|Analysis was not able to be completed for 3 participants in Arm I and 1 participant in Arm II.||ng/mL||Standard Deviation|Mean
764814|NCT00666562|Secondary|Absolute Change From Baseline of Other Catechins (Epicatechin Gallate, Epicatechin, and Epigallocatechin) Found in Polyphenon E Plasma Samples|The difference between the amount at the end of study (up to 28 days) from baseline.|Baseline and up to 28 days|Analysis was not able to be completed for 2 participants in Arm I and 1 participant in Arm II.||ng/mL||Standard Deviation|Mean
764815|NCT00666562|Secondary|Absolute Change From Baseline of Other Catechins (Epicatechin Gallate, Epicatechin, and Epigallocatechin) Found in Polyphenon E in Urine Samples|The difference between the amount at the end of study (up to 28 days) from baseline.|Baseline and up to 28 days|Analysis was not able to be completed for 3 participants in Arm I and 1 participant in Arm II.||ng/mL||Standard Deviation|Mean
764816|NCT00666562|Secondary|Levels of Other Catechins (Epicatechin Gallate, Epicatechin, and Epigallocatechin) Found in Polyphenon E Normal Tissue Samples||up to 28 days|Analysis was not able to be completed for 2 participants in Arm I and 2 participants in Arm III.||ng/mL||Standard Deviation|Mean
764817|NCT00666562|Secondary|Serum IGFBP-3 Levels Assessed by ELISA||Baseline and up to 28 days|Analysis was not able to be completed for 2 participants in Arm I.||ng/mL||Standard Deviation|Mean
764818|NCT00666562|Secondary|Metabolism of EGCG in Serum and Urine in Relation to Pharmacogenetic Polymorphisms in Catechol-O-Methyltransferase (COMT)||At Baseline|"This outcome was assessed in all participants,combined irrespective of their randomization.
Analysis was not able to be completed on 4 participants."||ng/mL||Standard Deviation|Mean
764819|NCT00666562|Secondary|Absolute Change for Baseline From EGCG in Serum Samples|The difference between the amount at the end of study (up to 28 days) from baseline.|Baseline and up to 28 days|Analysis was not able to be completed for 2 participants in Arm I and 1 participant in Arm II.||ng/mL||Standard Deviation|Mean
764820|NCT00666562|Secondary|Levels of Other Catechins (Epicatechin Gallate, Epicatechin, and Epigallocatechin) Found in Polyphenon E Tumor Tissue Samples||up to 28 days|Analysis was not able to be completed for 1 participant in Arm I, 1 participant in Arm II, and 3 participants in Arm III.||ng/mL||Standard Deviation|Mean
764821|NCT00666562|Secondary|Serum Insulin Growth Factor-1 (IGF-1) Levels Assessed by ELISA||Baseline and up to day 28|Analysis was not able to be completed for 2 participants in Arm I.||ng/mL||Standard Deviation|Mean
764822|NCT00666562|Secondary|Levels of Surrogate Intermediate Endpoint Biomarkers in Malignant and Nonmalignant Bladder Tissue Assessed by Immunohistochemistry||up to 28 days|||optical density||Standard Deviation|Mean
764823|NCT00666562|Secondary|Levels of EGCG in Malignant Bladder Tissue||up to 28 days|Analysis was not able to be completed for 1 participant in Arm I, 1 participant in Arm II, and 3 participants in Arm III.||ng/mL||Standard Deviation|Mean
764824|NCT00666562|Primary|Epigallocatechin Gallate (EGCG) Levels in Nonmalignant Bladder Tissue (e.g., Normal-appearing Urothelium, Inflammatory Lesions in the Bladder, Sessile Noninvasive Bladder Tumors, and Papillary Noninvasive Bladder Tumors)|Comparison of nonmalignant bladder tissue levels of EGCG between the placebo group and the EGCG groups combined using student t-test.|up to 28 days|||ng/mL||Standard Error|Mean
764825|NCT00666588|Secondary|Feasibility of Stem Cell Quantitation|Descriptive statistics to assess mean +/- standard deviation for stem cell percentage before and after bortezomib treatment. If there appears to be a difference in responders vs. nonresponders, stem cell percentage differences between responders and nonresponders will be compared using a paired t-test or equivalent nonparametric test.|At baseline and after completion of course 1||||||
764826|NCT00666588|Secondary|Protein Expression Assessed by Western Blot|Relative expression of apoptotic and cell cycle proteins will be characterized using descriptive statistics. If differences are noted between pre and post-treatment protein expression, pairwise comparisons will be made using paired t-test or an equivalent nonparametric test if the data are non-normally distributed. The normality assumption will be assessed on the log-transformed data prior to paired t-test evaluation.|At baseline, prior to and up to 24 hours after bortezomib treatment||||||
764827|NCT00666588|Secondary|Proteasome Inhibition Activity|Descriptive statistics will be used to determine the mean and standard deviation of proteasome inhibition.|At baseline, 2 hours prior to and 3 hours after first bortezomib dose||||||
764828|NCT00666588|Secondary|NF-kB Activity by Enzyme-linked Immunosorbent Assay (ELISA)|NF-kB activity will be measured as a continuous variable (ng NF-kB/Mg protein). Differences in NF-κB activity between time points will be assessed using summary statistics such as mean, standard deviation, and range. We may perform exploratory analyses to determine if single time point measurements, or the difference between time points, correlate with treatment response.|At baseline, prior to and up to 24 hours after bortezomib treatment||||||
764829|NCT00666588|Primary|Overall Response (Complete Remission [CR] and CR With Partial Recovery [CRp]) During Course 1|Overall response (complete remission [CR] and CR with partial recovery [CRp]) during course 1.|After course 1|||participants|||Number
764830|NCT00666588|Primary|Dose Limiting Toxicity|Number of participants with dose limiting toxicity.|During Course 1|||participants|||Number
764831|NCT00666666|Secondary|Percentage of Patients With Overall PSA < 4.0 ng/mL||3 years|||percentage of participants|||Number
764832|NCT00666666|Secondary|Percentage of Patients With PSA ≥ 0.2 ng/mL But < 4.0 ng/mL||3 years|||percentage of participants|||Number
764833|NCT00666666|Primary|Percentage of Patients With Undetectable Prostate-specific Antigen (PSA) (< 0.2 ng/mL) at End of 7 Cycles||3 years|||percentage of participants|||Number
764834|NCT00666679|Post-Hoc|Change From Baseline in FEV1 (Forced Expiratory Volume; Volume of Air That is Exhaled During the First Second of a Forced Exhalation) in Patients Who Met Lung Function Eligibility Criteria Specifically at the Randomization Visit.|To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on bronchodilation assessed by average change from baseline in FEV1 over the 2 week treatment period in patients who met lung function eligibility criteria at randomization; measurements taken at 1 and 2 weeks contributed to average.|Baseline and 2 Weeks|The analysis was based on a subset of the Full analysis set (FAS) population which included all randomized patients who took at least one dose of blinded post randomization study drug, had a measurement for analysis available in at least one treatment period and met lung function eligibility criteria specifically at the randomization visit.||L (Liter)||95% Confidence Interval|Least Squares Mean
764835|NCT00666679|Other Pre-specified|Change From Baseline in Total Peripheral Blood Eosinophils|To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on change from baseline in total peripheral blood eosinophils during the 2 week treatment period.|Baseline and 2 weeks|The analysis was based on the FAS population which included all randomized patients who took at least one dose of blinded post randomization study drug (inhaled montelukast or matching placebo) and had a measurement for analysis available in at least one treatment period of the cross-over design.||10^3/microliter||95% Confidence Interval|Least Squares Mean
764836|NCT00666679|Other Pre-specified|Percentage of Days With Asthma Exacerbations|To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on worsening of asthma assessed by percentage of days with asthma exacerbations during the 2 week treatment period.|2 Weeks|The analysis was based on the Completers Set population which included all randomized patients who took a dose of blinded post randomization study drug (inhaled montelukast or matching placebo) in both treatment periods and had a measurement for analysis available in both treatment periods of the cross-over design.||Percentage of Days||95% Confidence Interval|Least Squares Mean
764837|NCT00666679|Other Pre-specified|Percentage of Days With Asthma Control|To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on asthma control assessed by average percentage of days with asthma control over the 2 week treatment period; measurements taken at 1 and 2 weeks contributed to the average.|2 weeks|The analysis was based on the FAS population which included all randomized patients who took at least one dose of blinded post randomization study drug (inhaled montelukast or matching placebo) and had a measurement for analysis available in at least one treatment period of the cross-over design.||Percentage of Days||95% Confidence Interval|Least Squares Mean
764838|NCT00666679|Other Pre-specified|Change From Baseline in Total Daily β-agonist Use|To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on as-needed β-agonist use assessed by average change from baseline in total daily β-agonist use over the 2 week treatment period; measurements taken at 1 and 2 weeks contributed to the average.|Baseline and 2 weeks|The analysis was based on the FAS population which included all randomized patients who took at least one dose of blinded post randomization study drug (inhaled montelukast or matching placebo) and had a measurement for analysis available in at least one treatment period of the cross-over design.||Puffs||95% Confidence Interval|Least Squares Mean
764839|NCT00666679|Secondary|Change From Baseline in Nighttime Asthma Symptom Score|To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on asthma symptoms assessed by average change from baseline in nighttime asthma symptom score (which could range from 0 [best] to 3 [worst]) over the 2 week treatment period; measurements taken at 1 and 2 weeks contributed to the average.|Baseline and 2 weeks|The analysis was based on a subset of the FAS population which included all randomized patients with nighttime symptoms at baseline (score>0), who took at least one dose of blinded post randomization study drug (inhaled montelukast or matching placebo) and had a measurement for analysis available in at least one treatment period.||Units on a Scale||95% Confidence Interval|Least Squares Mean
764840|NCT00666679|Secondary|Change From Baseline in Daytime Asthma Symptom Score|To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on asthma symptoms assessed by average change from baseline in daytime asthma symptom score (which could range from 0 [best] to 6 [worst]) over the 2 week treatment period; measurements taken at 1 and 2 weeks contributed to the average.|Baseline and 2 weeks|The analysis was based on the FAS population which included all randomized patients who took at least one dose of blinded post randomization study drug (inhaled montelukast or matching placebo) and had a measurement for analysis available in at least one treatment period of the cross-over design.||Units on a Scale||95% Confidence Interval|Least Squares Mean
764841|NCT00666679|Primary|Change From Baseline in FEV1 (Forced Expiratory Volume; Volume of Air That is Exhaled During the First Second of a Forced Exhalation)|To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on bronchodilation assessed by average change from baseline in FEV1 over the 2 week treatment period; measurements taken at 1 and 2 weeks contributed to the average.|Baseline and 2 weeks|The analysis was based on the Full analysis set (FAS) population which included all randomized patients who took at least one dose of blinded post randomization study drug (inhaled montelukast or matching placebo) and had a measurement for analysis available in at least one treatment period of the cross-over design.||L (Liter)||95% Confidence Interval|Least Squares Mean
764842|NCT00666705|Other Pre-specified|Raltegravir Pharmacokinetics (PK) Parameter: 12-Hour Trough Concentration (C12)|Effect of maraviroc on pharmacokinetics of raltegravir (comparison of C12 of raltegravir co-administered with maraviroc (Test) vs. raltegravir administered alone (Reference)). Pharmacokinetics were assessed on Day 3 (raltegravir) and Day 14 (maraviroc and raltegravir). C12 is the 12-hour trough concentration.|Days 3 and 14|The Pharmacokinetic (PK) parameter analysis population is defined as all subjects enrolled and treated who have at least one of the PK parameters of primary interest in at least one treatment period.||ng/mL||Standard Deviation|Mean
764843|NCT00666705|Primary|Raltegravir Pharmacokinetics (PK) Parameter: Maximum Concentration (Cmax)|Effect of maraviroc on pharmacokinetics of raltegravir (comparison of Cmax of raltegravir co-administered with maraviroc (Test) versus raltegravir administered alone (Reference)). Pharmacokinetics assessed on Day 3 (raltegravir) and Day 14 (maraviroc and raltegravir). Cmax is the maximum plasma concentration.|Days 3 and 14|The Pharmacokinetic (PK) parameter analysis population is defined as all subjects enrolled and treated who have at least one of the PK parameters of primary interest in at least one treatment period.||ng/mL||Standard Deviation|Mean
764844|NCT00666705|Other Pre-specified|Maraviroc Pharmacokinetic (PK) Parameter: 12-Hour Trough Concentration (C12)|Effect of raltegravir on pharmacokinetics of maraviroc (comparison of C12 of raltegravir co-administered with maraviroc (Test) versus maraviroc administered alone (Reference)). Pharmacokinetics were assessed on Day 11 (maraviroc) and Day 14 (maraviroc and raltegravir). C12 is the 12-hour trough concentration.|Days 11 and 14|The Pharmacokinetic (PK) parameter analysis population is defined as all subjects enrolled and treated who have at least one of the PK parameters of primary interest in at least one treatment period.||ng/mL||Standard Deviation|Mean
764845|NCT00666705|Primary|Raltegravir Pharmacokinetics (PK) Parameter: Area Under the Plasma Concentration-time Profile Over the Dosing Interval (AUCτ)|Effect of maraviroc on pharmacokinetics of raltegravir (comparison of AUCτ of raltegravir co-administered with maraviroc (Test) versus raltegravir administered alone (Reference)). Pharmacokinetics were assessed on Day 3 (raltegravir) and Day 14 (maraviroc and raltegravir).|Days 3 and 14|The Pharmacokinetic (PK) parameter analysis population is defined as all subjects enrolled and treated who have at least one of the PK parameters of primary interest in at least one treatment period.||ng.hr/mL||Standard Deviation|Mean
764859|NCT00666757|Secondary|Change From Baseline in Weight at Week-12 Endpoint|Mean change from baseline to endpoint in weight|Baseline, 12 Weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=366, SSRI N=370; and Week 12: Duloxetine N=273, SSRI N=284||kilograms (kg)||Standard Error|Least Squares Mean
764846|NCT00666705|Primary|Maraviroc Pharmacokinetic (PK) Parameter: Maximum Concentration (Cmax)|Effect of raltegravir on pharmacokinetics of maraviroc (comparison of Cmax of raltegravir co-administered with maraviroc (Test) versus maraviroc administered alone (Reference)). Pharmacokinetics were assessed on Day 11 (maraviroc) and Day 14 (maraviroc and raltegravir). Cmax is the maximum plasma concentration.|Days 11 and 14|The Pharmacokinetic (PK) parameter analysis population is defined as all subjects enrolled and treated who have at least one of the PK parameters of primary interest in at least one treatment period.||ng/mL||Standard Deviation|Mean
764847|NCT00666705|Primary|Maraviroc Pharmacokinetic (PK) Parameter: Area Under the Plasma Concentration-time Profile Over the Dosing Interval (AUCτ)|Effect of raltegravir on pharmacokinetics of maraviroc (comparison of AUCτ of raltegravir co-administered with maraviroc (Test) versus maraviroc administered alone (Reference)). Pharmacokinetics were assessed on Day 11 (maraviroc) and Day 14 (maraviroc and raltegravir).|Days 11 and 14|The Pharmacokinetic (PK) parameter analysis population is defined as all subjects enrolled and treated who have at least one of the PK parameters of primary interest in at least one treatment period.||ng.hr/mL||Standard Deviation|Mean
764848|NCT00666718|Secondary|Number of Injections of Insulin at Week 24||Week 24|Full Analysis Set: All participants who enrolled in this study, were randomized to 1 of the study treatments, and had at least 1 post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.||Participants|||Number
764849|NCT00666718|Secondary|Total Daily Insulin Dose at Endpoint|LSMean values presented were controlled for treatment, country, and baseline HbA1C value.|Week 24|Full Analysis Set: All participants who enrolled in this study, were randomized to 1 of the study treatments, and had at least 1 post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.||Units||Standard Error|Least Squares Mean
764850|NCT00666718|Secondary|Change in Body Weight From Baseline to Week 24|LSMean values presented were controlled for treatment, country, and baseline HbA1C value.|Baseline, Week 24|Per-Protocol Population: All enrolled participants who were randomized and met the following criteria: no violations of Inclusion/Exclusion Criteria have not discontinued study prior to Week 24, compliant as assessed by investigator, and have not been on systemic glucocorticoid therapy for more than 14 consecutive days.||Kilograms (kg)||Standard Error|Least Squares Mean
764851|NCT00666718|Secondary|Number of Participants With Adverse Events (AE)|A listing of adverse events is located in the Reported Adverse Event module.|Baseline through Week 24|Safety population - all participants who received at least one dose of study drug.||participants|||Number
764852|NCT00666718|Secondary|Percentage of Participants With Self-Reported Hypoglycemic Episodes|Episode=any time a patient feels that he/she is experiencing a sign or symptom associated with hypoglycemia or has a blood glucose level of ≤70 mg/dL, even if not associated with signs,symptoms, or treatment. Overall=any time post-randomization visits in the study period. Nocturnal=Episode that occurs between bedtime and waking. Non-Nocturnal=Episode occurring between waking and bedtime. Severe=episode with symptoms of neuroglycopenia in which patient requires assistance,and has blood glucose value <50 mg/dL or prompt recovery after oral carbohydrate, glucagon, or intravenous glucose.|Baseline through Week 24|Safety population - all participants who received at least one dose of study drug.||percentage of participants|||Number
764853|NCT00666718|Secondary|Rate Of All Self-reported Hypoglycemic Episodes|Rate of self-reported hypoglycemic episodes, all, non-nocturnal,and nocturnal, severe, documented ≤3.9 mmol/L and ≤3.0 mmol/L. Rate=episodes/30 days/patient/. Episode=any time a patient has a symptom associated with hypoglycemia or blood glucose level of ≤70 mg/dL,even if not associated with symptoms.Overall=any time post-randomization in the study period. Nocturnal=Episode between bedtime and waking. Non-Nocturnal=Episode between waking and bedtime.Severe:episode in which patient requires assistance,and has glucose <50 mg/dL or prompt recovery after oral carbohydrate, glucagon, or IV glucose.|Baseline through Week 24|Safety population - all participants who received at least one dose of study drug.||episode/30 days/participant||Standard Error|Least Squares Mean
764854|NCT00666718|Secondary|Glycemic Variability at Endpoint|LSMeans were controlled for treatment and country grouping (Mediterranean, rest of Europe). Glycemic variability was assessed as the standard deviations of 4 fasting SMBG samples, 4 post-breakfast measurements, 4 post-lunch measurements, 4 post-evening meal measurements.|Week 24|Full Analysis Set: All participants who enrolled in this study, were randomized to 1 of the study treatments, and had at least 1 post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.||mmol/L||Standard Error|Least Squares Mean
764855|NCT00666718|Secondary|7-point Self-monitored Blood Glucose Profiles (SMBG) at Endpoint|LSMean values presented were controlled for treatment, country, and baseline HbA1C value. SMBG at morning pre-meal, morning postprandial, midday pre-meal, midday postprandial, evening pre-meal, evening postprandial, 0300 hours. Postprandial glucose is measured 2 hours after the start of the meal.|24 weeks|Full Analysis Set: All participants who enrolled in this study, were randomized to 1 of the study treatments, and had at least 1 post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
764856|NCT00666718|Secondary|Percentage of Participants With HbA1c Less Than 7.0% and Less Than or Equal to 6.5% at Endpoint||Week 24|Full Analysis Set: All patients who enrolled in this study, were randomized to 1 of the study treatments, and had at least 1 post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.||Percent of Participants|||Number
764857|NCT00666718|Secondary|Change From Baseline in HbA1c at Week 12 and Week 24|LSMean values presented were controlled for treatment, country, baseline HbA1C value and week.|Baseline, Week 12, Week 24|Full Analysis Set: All participants who enrolled in this study, were randomized to 1 of the study treatments, and had at least 1 post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.||Percent of Glycosylated Hemoglobin||95% Confidence Interval|Least Squares Mean
764858|NCT00666718|Primary|Change From Baseline in Hemoglobin A1c (HbA1c) to Week 24|Least Squares Mean (LSMean) values reported in the table were controlled for treatment, country, and baseline HbA1c value.|Baseline, Week 24|Per-Protocol Population: All enrolled participants who were randomized and met the following criteria: no violations of Inclusion/Exclusion Criteria have not discontinued study prior to Week 24, compliant as assessed by investigator, and have not been on systemic glucocorticoid therapy for more than 14 consecutive days.||Percent of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
769119|NCT00709124|Secondary|Hospital Discharge Destination (e.g., Home, Rehab Facility)||Hospital discharge||||||
769120|NCT00709124|Secondary|Total Hospital Charges||Hospital discharge||||||
764860|NCT00666757|Secondary|Change From Baseline in Pulse Rate at Week-12 Endpoint|Mean change from baseline to endpoint in pulse rate|Baseline, 12 Weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=367, SSRI N=371; and Week 12: Duloxetine N=274, SSRI N=285||beats per minute (bpm)||Standard Error|Least Squares Mean
764861|NCT00666757|Other Pre-specified|Change From Baseline in World Health Organization Health and Work Performance Questionnaire, Clinical Trials 7-Day Version (HPQ), Presenteeism Score, at Week-12 Endpoint|"Self-administered assessment used to determine a participant's work performance (employment status, absenteeism if employed, productivity while at work, usual occupation, & annual income). Tool assesses the potential impact of change in depressive symptoms on work productivity & its associated employer costs using a 0–100 scale in which 0 meant doing no work at all on days spent at work and 100 meant performing at the level of a top worker. Absolute presenteeism: difference between score for self and score for average worker in same job. Mean change baseline to endpoint is reported."|Baseline, 12 Weeks|Intent to Treat. Last Observation Carried Forward.||units on a scale||Standard Error|Least Squares Mean
764862|NCT00666757|Other Pre-specified|Change From Baseline in World Health Organization Health and Work Performance Questionnaire, Clinical Trials 7-Day Version (HPQ), Absenteeism at 12-Week Endpoint|Self-administered assessment used to determine a subject's work performance in terms of employment status, absenteeism if employed, productivity while at work, usual occupation, and annual income. Tool assesses the potential impact of change in depressive symptoms on work productivity and its associated employer costs. Defined on a 0–100 scale for the percentage of work days the respondent missed in the past 30 days. Absolute absenteeism: actual hours worked minus expected hours equals number of missed work days. Mean change baseline to endpoint is reported.|Baseline, 12 Weeks|Intent to Treat. Last Observation Carried Forward.||hours lost per week||Standard Error|Least Squares Mean
764863|NCT00666757|Secondary|Change From Baseline in Diastolic Blood Pressure at Week-12 Endpoint|Mean change from baseline to endpoint in diastolic blood pressure|Baseline, 12 Weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=367, SSRI N=371: and Week 12: Duloxetine N=274, SSRI N=285||mmHg||Standard Error|Least Squares Mean
764864|NCT00666757|Secondary|Change From Baseline in Systolic Blood Pressure at Week-12 Endpoint|Mean change from baseline to endpoint in systolic blood pressure|Baseline, 12 Weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=367, SSRI N=371; and Week 12: Duloxetine N=274, SSRI N=285||millimeters of mmercury (mmHg)||Standard Error|Least Squares Mean
764865|NCT00666757|Secondary|Change From Baseline in SDS Social Item Score at 12-Week Endpoint (Functional Outcome Measure)|The SDS is completed by the participant and is used to assess the effect of the participant's symptoms on their work/social/family life. Total scores range from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life.|Baseline, 12 Weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=362, SSRI N=370; and Week 12: Duloxetine N=270, SSRI N=283||units on a scale||Standard Error|Least Squares Mean
764866|NCT00666757|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Family/Home Item Score at Week-12 Endpoint (Functional Outcome Measure)|The SDS is completed by the participant and Item 3 is used to assess the effect of the participant's symptoms on their family life/home responsibilities. Scores range from 0 to 10 with higher values indicating greater disruption in the participant's family life/home responsibilities.|Baseline, 12 Weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=363, SSRI N=370; and Week 12: Duloxetine N=271, SSRI N=283||units on a scale||Standard Error|Least Squares Mean
764867|NCT00666757|Other Pre-specified|Change From Baseline in World Health Organization Health and Work Performance Questionnaire, Clinical Trials 7-Day Version (HPQ), Dollars of Income Lost Due to Work Absenteeism Score at Week-12 Endpoint|Self-administered assessment used to determine a participant's work performance in terms of employment status, absenteeism if employed, productivity while at work, usual occupation, and annual income. Tool assesses the potential impact of change in depressive symptoms on work productivity and its associated employer costs. Scale ranges from 0 to 100% of work days in past 30 days. Absenteeism and presenteeism were combined into a measure of total lost work performance by adding absenteeism to the value ([100–absenteeism] × [100–presenteeism]). Mean change baseline to endpoint.|Baseline, 12 weeks|Intent to Treat. Last Observation Carried Forward.||dollars||Standard Error|Least Squares Mean
764868|NCT00666757|Other Pre-specified|Change From Baseline in World Health Organization Health and Work Performance Questionnaire, Clinical Trials 7-Day Version (HPQ), Dollars of Income Lost Due to Work Presenteeism (WP)Score, at Week-12 Endpoint|WP score was calculated by taking midpoint of annual before-tax income reported on HPQ. A multiplier of 1.25 produced estimated direct & indirect (i.e. benefits) income. Annual hours expected to work were calculated from expected daily work hours, multiplied by 236 days. Hourly, indirect income was total direct + indirect income, divided by # of expected annual work hours. Indirect hours lost annually for WP=hours expected to be worked annually times WP percent, times hourly rate=dollars earned, and then subtracted from total direct + indirect income=dollars lost annually due to WP.|Baseline, 12 Weeks|Intent to Treat. Last Observation Carried Forward.||dollars||Standard Error|Least Squares Mean
764869|NCT00666757|Secondary|Change From Baseline in SDS Work/School Item Score at 12-Week Endpoint (Functional Outcome Measure)|The SDS is completed by the participant and Item 1 is used to assess the effect of the participant's symptoms on their work/school schedule. Scores range from 0 to 10 with higher values indicating greater disruption in the participant's work/school life.|Baseline, 12 Weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=260,SSRI N=267; and Week 12: Duloxetine N=182, SSRI N=192||units on a scale||Standard Error|Least Squares Mean
764870|NCT00666757|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Global Functional Impairment Score at 12-Week Endpoint (Functional Outcome Measure)|The SDS is a participant-rated anchored visual analog scale to assess disability across the three domains of work/school, social life, and family life, with each item scored from 0 (not at all) to 10 (very severely), with a summarization of the 3 items to evaluate global functioning. The Global Functional Impairment Score is a total score score that ranges from 0 (unimpaired) to 30 (highly impaired), and was used to derived the mean change from baseline to endpoint.|Baseline, 12 weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=362, SSRI N=370; and Week 12: Duloxetine N=270, SSRI N=283||units on a scale||Standard Error|Least Squares Mean
769121|NCT00709124|Secondary|ICU and In-hospital Mortality||Hospital discharge||||||
764871|NCT00666757|Secondary|Change From Baseline in BPI Average 24 Hour Pain Score at 12-Week Endpoint (Pain Measure)|The BPI is a self-reported scale measuring pain severity and pain-specific interference on function, with scores ranging from 0 (does not interfere) to 10 (completely interferes). The BPI average 24-hour pain measure was used to derive the overall mean change from baseline to endpoint.|Baseline, 12 weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=346, SSRI N=348; and Week 12: Duloxetine N=249, SSRI N=257||units on a scale||Standard Error|Least Squares Mean
764872|NCT00666757|Secondary|Change From Baseline in Brief Pain Inventory (BPI) Average 24-hour Pain Score, in Particpants With a Baseline BPI Average 24-hour Pain Score of 3 or Greater, at 12-Week Endpoint (Pain Measure)|The BPI is a self-reported scale measuring pain severity and pain-specific interference on function on a scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). The BPI average 24-hour pain measure was used to derive the overall mean change from baseline to endpoint, in those participants who had a BPI average 24-hour pain score of 3 or greater at baseline.|Baseline, 12 Weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=211, SSRI N=233; and Week 12: Duloxetine N=156, N=166||units on a scale||Standard Error|Least Squares Mean
764873|NCT00666757|Secondary|Change From Baseline in HAMD-17 Sleep Subscale Score at 12-Week Endpoint (Mood Measure)|The HAMD-17 Sleep Subscale consists of Items 4, 5, 6 and evaluates initial, middle, and late insomnia. Total subscale scores range from 0 (no difficulty) to 6 (difficulty).|Baseline, 12 Weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=367, SSRI N=371; and Week 12: Duloxetine N=274, SSRI N=285||units on a scale||Standard Error|Least Squares Mean
764874|NCT00666757|Secondary|Change From Baseline in HAMD-17 Retardation Subscale Score at 12-Week Endpoint (Mood Measure)|The HAMD-17 Retardation subscale consists of Items 1, 7, 8, 14 and evaluates dysfunction in mood, work, and sexual activity, as well as overall motor retardation. Total subscale scores range from 0 (normal) to 14 (severe).|Baseline, 12 Weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=366, SSRI N=371; and Week 12: Duloxetine N=273, SSRI N=284||units on a scale||Standard Error|Least Squares Mean
764875|NCT00666757|Secondary|Change From Baseline in HAMD-17 Bech Subscale Score at 12-Week Endpoint (Mood Measure)|HAMD-17 Bech subscale consists of items 1, 2, 7, 8, 10, and 13 used to evaluate core symptoms of Major Depressive Disorder (MDD). Total subscale scores range from 0 (normal) to 22 (severe).|Baseline, 12 Weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=367, SSRI N=371; and Week 12: Duloxetine N=274; SSRI N=284||units on a scale||Standard Error|Least Squares Mean
764876|NCT00666757|Secondary|Change From Baseline in HAMD-17 Maier Subscale Score at 12-Week Endpoint (Mood Measure)|"HAMD-17 Maier Subscale consists of Items 1, 2, 7, 8, 9, 10 and represents the core symptoms of depression. Total subscale scores range from 0 (normal) to 24 (severe)."|Baseline, 12 weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=367, SSRI N=371; and Week 12: Duloxetine N=274, SSRI N=284||units on a scale||Standard Error|Least Squares Mean
764877|NCT00666757|Secondary|Change From Baseline in HAMD-17 Anxiety/Somatization Subscale Score at 12-Week Endpoint (Mood Measure)|HAMD-17 subscale consists of items 10, 11, 12, 13, 15, and 17 evaluates agitation, and severity of psychic and somatic manifestations of anxiety. Total subscale scores range from 0 (normal) to 18 (severe). Mean change from baseline to endpoint.|Baseline, 12 Weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=367, SSRI N=371; and Week 12: Duloxetine N=274, SSRI N=284||units on a scale||Standard Error|Least Squares Mean
764878|NCT00666757|Secondary|Change From Baseline in HAMD-17 Total Score at 12-Week Endpoint (Mood Measure)|The HAMD-17 is a rater-administered assessment of depression severity and improvement, with total score ranges from 0 (not at all depressed) to 52 (most severely depressed).|Baseline, 12 Weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=365, SSRI N=371; and; and Week 12: Duloxetine N=272, SSRI N=283||units on a scale||Standard Error|Least Squares Mean
764879|NCT00666757|Secondary|Probability of Response [HAMD-17 Total Score (Mood Measure) Greater Than Or Equal To 50 Percent Reduction From Baseline To 12 Week Endpoint]|Visitwise percentages of participants meeting response criteria 50% reduction from baseline in HAMD-17 total score at 12-Week endpoint) were estimated using a categorical, pseudolike-lihood-based repeated measures approach, & included fixed, categorical effects of treatment group, visit, treatment group-by-visit interaction, & continuous, fixed covariate of baseline HAMD-17 TS. Primary analysis will be the contrast of response rates at week 12 endpoint between treatment groups, & represents estimated response rates for each treatment group had all participants completed 12 weeks of therapy.|Baseline, 12-Weeks|Intent to treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=365, SSRI N=371; and Week 12: Duloxetine N=272, SSRI N=283||Probability of response||Standard Error|Least Squares Mean
764880|NCT00666757|Secondary|Probability of Response [QIDS-SR Total Score (Mood Measure) Greater Than Or Equal To 50 Percent Reduction From Baseline To 12 Week Endpoint]|Visitwise percentages of participants meeting response criteria (50% reduction from baseline QIDS-SR total score at 12-week endpoint) were estimated using a categorical, pseudolikelihood-based repeated measures approach, & included fixed, categorical effects of treatment group, visit, treatment group-by-visit interaction, & continuous, fixed covariate of baseline QIDS-SR. The primary analysis will be the contrast of response rates at week 12 endpoint between treatment groups, and represents estimated response rates for each treatment group had all participants completed 12 weeks of therapy.|Baseline, 12-Weeks|Intent to treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=366, SSRI N=371; and Week 12: Duloxetine N=273, SSRI N=284||Probability of response||Standard Error|Least Squares Mean
764881|NCT00666757|Secondary|Probability of Remission [17-item Hamilton Depression Rating Scale (HAMD-17) (Mood Measure) Less Than or Equal to 7 at 12-Week Endpoint]|Visitwise percentages of participants meeting remission criteria HAMD-17 total score [TS] </=7 at week 12 endpoint) were estimated using a categorical, pseudolike-lihood-based repeated measures approach, & included fixed, categorical effects of treatment group (duloxetine vs. SSRIs), visit, treatment group-by-visit interaction, & continuous, fixed covariate of baseline HAMD-17 TS. Primary analysis will be contrast of remission rates at week 12 endpoint between treatment groups, & represents estimated remission rates for each treatment group had all participants completed 12 weeks of therapy.|12 weeks|Intent to treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=365, SSRI N=371 and Week 12: Duloxetine N=272, SSRI N=283||Probability of remission||Standard Error|Least Squares Mean
769122|NCT00709124|Secondary|ICU and Hospital Length of Stay||Hospital discharge||||||
764882|NCT00666757|Secondary|Change From Baseline in QIDS-SR Total Score at 12-Week Endpoint (Mood Measure)|The QIDS-SR is a 16-item, participant-rated short form of the Inventory of Depressive Symptomatology that assesses 9 domains: sad mood, concentration, self-outlook, suicidal ideation, involvement, energy/fatigability, sleep disturbance, appetite/weight increase/decrease and psychomotor agitation/retardation. Scores range from 0 (none) to 27 (very severe). The QIDS-SR total score was used to derive the mean change from baseline to endpoint depression.|Baseline, 12 weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=366, SSRI N=371; and Week 12: Duloxetine N=273, SSRI N=284||units on a scale||Standard Error|Least Squares Mean
764883|NCT00666757|Primary|Probability of Remission [16-item Quick Inventory of Depressive Symptomatology (QIDS-SR) Score Less Than or Equal to 5 at 12-Week Endpoint]|Visitwise probability of participants per treatment meeting remission criteria (QIDS-SR total score [TS]</=5 at week 12 endpoint) were estimated using a pseudolikelihood-based mixed-models repeated measures analysis for a categorical outcome, model included fixed, categorical effects of treatment group (duloxetine vs. SSRIs), visit, treatment group-by-visit & continuous, fixed covariate of baseline QIDS-SR TS, and random effect of participant. Primary analysis contrasted remission probability at week 12 endpoint between treatment groups.|12 weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=366, SSRI N=371; and Week 12: Duloxetine N=273, SSRI N=284||Probability of remission||Standard Error|Least Squares Mean
764884|NCT00660816|Secondary|Disease Stabilization Rate (e.g., Complete Response, Partial Response, and Stable Disease)|Estimated based on number of evaluable patients with complete response, partial response or stable disease|36 months after enrollment of last patient|Patients with a complete response, partial response, stable disease, or progressive disease||participants|||Number
764885|NCT00660816|Secondary|Response Rate|Estimated based on the number of responses by excluding the dropouts who are not evaluable for response using a binomial distribution|36 months after enrollment of last evaluable patient|Patients with a complete response, partial response, stable disease, or progressive disease||participants|||Number
764886|NCT00660816|Secondary|Overall Survival|Measured from the date of randomization to the date of death, whichever occurs first and censored at the date of last followed for those survivors|36 months after enrollment of last patient|||Months||95% Confidence Interval|Median
764887|NCT00660816|Primary|Progression-free Survival|From the date of randomization to the date of disease progression or the date of death, whichever occurs first and censored at the date of last followed for those survivors without disease progression.|18 months after enrollment of last patient|||Months||95% Confidence Interval|Median
764888|NCT00660829|Secondary|Change From Baseline on Direct Visual Nasal Exams at 14 Days|Examination of head and neck (scale: None, Mild, Moderate, Severe) for Epistaxis, Mucosal Edema, Nasal Discharge, Mucosal erythema, Mucosal Bleeding, and Crusting of mucosa. Nasal irritation was rated: 0 = None, Grade 1A = focal irritation, Grade 1B = superficial mucosal erosion, Grade 2 = moderate mucosal erosion, Grade 3 = ulceration, Grade 4 = septal perforation|baseline and 14 Days|||Participants|||Number
764889|NCT00660829|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)|"A 28-item RQLQ was completed on Day 1 and Day 14 or Early termination. The RQLQ consists of 7 domains rated on a 7 point scale with 0 being not troubled by the allergy symptoms, and 6 being extremely troubled/all of the time.
Scores for a series of subscales are not combined for a total overall score, rather domain score will be calculated from the mean score of all items in the domain. Overall score will be calculated from the mean score of all items."|baseline and 14 Days|ITT||Units on a scale||Standard Deviation|Least Squares Mean
764890|NCT00660829|Secondary|Change From Baseline in 12-hour Reflective Secondary Symptom Complex Score (SSCS) for the Entire 14-day Study Period Compared to Placebo (AM and PM Combined)|"Reflective secondary complex symptom scores (SSCS) (post-nasal drip, itchy eyes, cough and headache) were assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible SSCS score is 24 per day.
Least Means Square was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and baseline as co-variate"|baseline and 14-days|||Scores on a scale||Standard Deviation|Least Squares Mean
764891|NCT00660829|Secondary|Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (AM and PM Combined) at 14 Days|"instantaneous (subjects rate how they feel right now) total nasal symptom score consisting of runny nose, itchy nose, nasal congestion, and sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible score is 24 per day.
Least Means Square was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and baseline as co-variate"|baseline and 14-days|ITT||Scores on a scale||Standard Deviation|Least Squares Mean
764892|NCT00660829|Secondary|Mean Change From Baseline in Instantaneous Total Nasal Symptom Score (AM) for the Entire 14-day Study Period Compared to Placebo.|"End of 24 hour dosing interval: This endpoint is change from baseline in instantaneous (tNSS) for the 14-day study period compared to placebo to observe if the duration of efficacy lasts 24 hours on a day to day basis. Instantaneous (tNSS) consists of runny nose, itchy nose, nasal congestion, and sneezing. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe.Total possible score is 24 per day.
Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and baseline as a covariate."|baseline and 14 days|||Scores on a scale||Standard Error|Least Squares Mean
764893|NCT00660829|Primary|Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (TNSS) (AM and PM Combined)at 14 Days|"reflective total nasal symptom score consisting of runny nose, itchy nose, nasal congestion, and sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible score is 24 per day.
Least Means Square was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and baseline as co-variate"|baseline and 14 days|ITT||Scores on a scale||Standard Deviation|Least Squares Mean
764894|NCT00660907|Secondary|Proportion of Participants With Body Weight Reduction of at Least 5%|To evaluate the effect of dapagliflozin plus metformin compared to glipizide plus metformin on body weight assessed by a reduction after 52 weeks of at least 5% compared to baseline. Least Squares Mean represents the percent of participants adjusted for baseline value.|Baseline to Week 52|Full Analysis Set, participants with non-missing baseline and Week 52 (LOCF) values||Percentage of participants||95% Confidence Interval|Least Squares Mean
764895|NCT00660907|Secondary|Proportion of Participants With at Least One Episode of Hypoglycemia|To assess the effect of dapagliflozin plus metformin treatment compared to glipizide plus metformin on the occurrence of hypoglycemic events. Least Squares Mean represents the percent of participants adjusted for HbA1c baseline value.|Baseline to Week 52|Full analysis set||Percentage of participants||95% Confidence Interval|Least Squares Mean
764896|NCT00660907|Secondary|Adjusted Mean Change in Body Weight|To assess the effect of dapagliflozin plus metformin compared to glipizide plus metformin on body weight after 52 weeks double-blind treatment.|Baseline to Week 52|Full Analysis Set, participants with non-missing baseline and Week 52 (LOCF) values||kg||95% Confidence Interval|Least Squares Mean
764897|NCT00660907|Primary|Adjusted Mean Change in HbA1c Levels|To assess the effect of dapagliflozin plus metformin compared to glipizide plus metformin on the absolute change from baseline in HbA1c level after 52 weeks double-blind treatment in patients with type 2 diabetes who have inadequate glycaemic control on 1500 mg/day or higher doses of metformin therapy alone.|Baseline to Week 52|Full Analysis Set, participants with non-missing baseline and Week 52 (LOCF) values||percent||95% Confidence Interval|Least Squares Mean
764898|NCT00660985|Primary|Area Under the Plasma Concentration Versus Time Curve for 0 to 24 Hours Post Dose Measured on Day 30 (AUC (0-24))|area under the concentration-time curve calculated mixed linear-logarithmic trapezoidal method from pre-application (T0) through 24hr (corresponding to the dosing interval)|T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr, T32hr, T36hr, T48hr, T72hr (post dose)|||ng*h/mL||Standard Deviation|Mean
764899|NCT00660985|Primary|Area Under the Plasma Concentration Versus Time Curve for 0 to 24 Hours Post Dose Measured on Day 15 (AUC (0-24))|area under the concentration-time curve calculated mixed linear-logarithmic trapezoidal method from pre-application (T0) through 24hr (corresponding to the dosing interval)|T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr (post dose)|||ng*h/mL||Standard Deviation|Mean
764900|NCT00660985|Primary|Area Under the Plasma Concentration Versus Time Curve for 0 to 24 Hours Post Dose Measured on Day 1 (AUC (0-24))|area under the concentration-time curve calculated mixed linear-logarithmic trapezoidal method from pre-application (T0) through 24 hr (corresponding to the dosing interval)|T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr (post dose)|||ng*h/mL||Standard Deviation|Mean
764901|NCT00660985|Primary|Tmax (hr) at Day 30|the time at which Cmax occurs|T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr, T32hr, T36hr, T48hr, T72hr (post dose)|26 subjects in the Differin Gel 0.3% and 25 subjects in the Differin Gel 0.1% were included in the study. 20 subjects in the Differin Gel 0.3% and 4 subjects in the Differin Gel 0.1% were detectable at Day 30.||hours||Standard Deviation|Mean
764902|NCT00660985|Primary|Tmax (hr) at Day 15|the time at which Cmax occurs|T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr (post dose)|26 subjects in the Differin Gel 0.3% and 25 subjects in the Differin Gel 0.1% were included in the study. 23 subjects in the Differin Gel 0.3% and 7 subjects in the Differin Gel 0.1% were detectable at Day 15.||hours||Standard Deviation|Mean
764903|NCT00660985|Primary|Tmax (hr) at Day 1|the time at which Cmax occurs|T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr (post dose)|26 subjects in the Differin Gel 0.3% and 25 subjects in the Differin Gel 0.1% were included in the study. 14 subjects in the Differin Gel 0.3% and 4 subjects in the Differin Gel 0.1% were detectable at Day 1.||hours||Standard Deviation|Mean
764904|NCT00660985|Primary|Cmax (ng/mL) at Day 30|the observed peak drug (adapalene) concentration|T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr, T32hr, T36hr, T48hr, T 72hr (post dose)|||ng/mL||Standard Deviation|Mean
764905|NCT00660985|Primary|Cmax (ng/mL) at Day 15|the observed peak drug (adapalene) concentration|T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr (post dose)|||ng/mL||Standard Deviation|Mean
764906|NCT00660985|Primary|Cmax (ng/mL) at Day 1|the observed peak drug (adapalene) concentration|T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr (post dose)|||ng/mL||Standard Deviation|Mean
764907|NCT00661037|Secondary|Sudden Cardiac Death at Follow up or Resusciation After Ineffective Documented Appropriate ICD Shocks at Follow up||2 years|||Participants|||Count of Participants
764908|NCT00661037|Secondary|Severe Intra-operative Complications|including: cardiopulmonary arrest, transient ischemic attack or stroke, cardiogenic shock, pulmonary edema, embolic event, anoxic coma, pericardial tamponade,death|Acute (ICD implant)|||Participants|||Count of Participants
764909|NCT00661037|Primary|Number of Participants With Severe Intra-operative Complications at ICD Implant and/or Events at Follow up|"Severe implant-related* complications at ICD implants among the following:
Survival from cardiopulmonary arrest due to VF requiring 3 or more consecutive external shocks for termination or due to electro-mechanical dissociation.
Transient ischemic attack or stroke,
Cardiogenic shock,
Pulmonary edema,
Embolic events,
Anoxic coma
Pericardial tamponade
Death.
Events at follow up:
Sudden cardiac death (defined as witnessed unexpected death occurring <1 hour from symptoms onset or unwitnessed during sleep)
Resuscitation after ineffective documented appropriate ICD shocks
Implant related events are considered as those listed above, occurring during the implant procedure in the timeframe betweend device poket insertion and patient exit from the cath-lab, as well as those events occurring after the patient exit from the cath-lab that, after review from the event adjudication committee, have been classified as related to the implant procedure."|2 years|||Participants|||Count of Participants
764910|NCT00661089|Primary|Change in Pain Rating From Baseline to Four Weeks|Change scores from patient ratings VAS on mm scale for worst pain, averaged over a week for ratings performed at baseline and week four. Scale range 0-100 mm. 0= No pain, 100= worst pain|baseline and four weeks|||units on a scale 0-100mm||Inter-Quartile Range|Median
764911|NCT00661089|Secondary|Ability to Perform Hygiene Rating||2,4,12, and 16 weeks||||||
764912|NCT00661089|Secondary|Time to Don a Pull Over Shirt||2,4,12, and 16 weeks||||||
764913|NCT00661089|Secondary|Change in Disability Assessment Scale for Hygiene|Subject rating of scores on the Disability Assessment Scale Range 0-3, 0= no disability, 3= severe disability|baseline and 4 weeks post injection|||units on a scale from 0-3||Inter-Quartile Range|Median
764988|NCT00673153|Primary|Number of Participants Achieving CR or CRi With Induction Therapy (Good-risk Group)||after completion of induction therapy, administered every 21-42 days for up to two courses|Good-risk Group: aged 60-69 years with performance status 0-3, or aged ≥70 years and performance status 0-1||Participants|||Count of Participants
764914|NCT00661141|Secondary|PK of Acetaldehyde: T1/2||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.||hours||Standard Deviation|Mean
764915|NCT00661141|Secondary|PK of Acetaldehyde: AUC%Extrap||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.||percentage||Standard Deviation|Mean
764916|NCT00661141|Secondary|PK of Acetaldehyde: DN AUC(0-∞)||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.||µM*hr/mg||Standard Deviation|Mean
764917|NCT00661141|Secondary|PK of Acetaldehyde: AUC(0-∞)||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.||µM*hr||Standard Deviation|Mean
764918|NCT00661141|Secondary|PK of Acetaldehyde: DN AUC(0-t)||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.||µM*hr/mg||Standard Deviation|Mean
764919|NCT00661141|Secondary|PK of Acetaldehyde: AUC(0-t)||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.||µM*hr||Standard Deviation|Mean
764920|NCT00661141|Secondary|PK of Acetaldehyde: Tmax||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.||hours||Full Range|Median
764921|NCT00661141|Secondary|PK of Acetaldehyde: DN Cmax||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.||µM/mg||Standard Deviation|Mean
764922|NCT00661141|Secondary|PK of Acetaldehyde: Cmax||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.||µM||Standard Deviation|Mean
764923|NCT00661141|Secondary|PK of Ethanol: Vz/F||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure, received study assessments through Study Day 2, and who had available data.||dL||Standard Deviation|Mean
764924|NCT00661141|Secondary|PK of Ethanol: CL/F||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure, received study assessments through Study Day 2, and who had available data.||dL/hr||Standard Deviation|Mean
764925|NCT00661141|Secondary|PK of Ethanol: T1/2||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure, received study assessments through Study Day 2, and who had available data.||hours||Standard Deviation|Mean
764926|NCT00661141|Secondary|PK of Ethanol: AUC%Extrap||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure, received study assessments through Study Day 2, and who had available data.||percentage||Standard Deviation|Mean
764927|NCT00661141|Secondary|PK of Ethanol: DN AUC(0-∞)||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure, received study assessments through Study Day 2, and who had available data.||(mg*hr/dL)/mg||Standard Deviation|Mean
764928|NCT00661141|Secondary|PK of Ethanol: AUC(0-∞)||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.||mg*hr/mL||Standard Deviation|Mean
764989|NCT00673179|Secondary|Quality of Life (Ped QL) Assessment||Peds QL measures at week 0 (during first chemo cycle), week 6, week 20, at end of therapy, and at 3 years.||||||
764929|NCT00661141|Secondary|PK of Ethanol: DN AUC(0-t)||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.||(mg*hr/dL)/mg||Standard Deviation|Mean
764930|NCT00661141|Secondary|PK of Ethanol: AUC(0-t)||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.||mg*hr/dL||Standard Deviation|Mean
764931|NCT00661141|Secondary|PK of Ethanol: Tmax||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.||hours||Full Range|Median
764932|NCT00661141|Secondary|PK of Ethanol: DN Cmax||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.||(mg/dL)/mg||Standard Deviation|Mean
764933|NCT00661141|Secondary|PK of Ethanol: Cmax||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.||mg/dL||Standard Deviation|Mean
764934|NCT00661141|Secondary|PK of 4-MP: Apparent Volume of Distribution During Terminal Phase (Vz/F)||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure, received study assessments through Study Day 2, and who had available data.||Liters||Standard Deviation|Mean
764935|NCT00661141|Secondary|PK of 4-MP: Apparent Clearance (CL/F)||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure, received study assessments through Study Day 2, and who had available data.||L/hr||Standard Deviation|Mean
764936|NCT00661141|Secondary|PK of 4-MP: Half-Life (T1/2)||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure, received study assessments through Study Day 2, and who had available data.||hours||Standard Deviation|Mean
764937|NCT00661141|Secondary|PK of 4-MP: Percentage of AUC0–∞ Obtained by Extrapolation (AUC%Extrap)||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure, received study assessments through Study Day 2, and who had available data.||percentage||Standard Deviation|Mean
764938|NCT00661141|Secondary|PK of 4-MP: DN AUC(0-∞)||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure, received study assessments through Study Day 2, and who had available data.||(ng*hr/mL)/mg||Standard Deviation|Mean
764939|NCT00661141|Secondary|PK of 4-MP: AUC, From Time 0 Extrapolated to Infinite Time (AUC[0-∞])||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure, received study assessments through Study Day 2, and who had available data.||ng*hr/mL||Standard Deviation|Mean
764940|NCT00661141|Secondary|PK of 4-MP: DN AUC(0-t)||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.||(ng*hr/mL)/mg||Standard Deviation|Mean
764941|NCT00661141|Secondary|PK of 4-MP: Area Under the Plasma Concentration-Time Curve (AUC), Calculated to the Last Measured Concentration (AUC[0-t])||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.||ng*hr/mL||Standard Deviation|Mean
764942|NCT00661141|Secondary|PK of 4-MP: Time to Cmax (Tmax)||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.||hours||Full Range|Median
764943|NCT00661141|Secondary|PK of 4-MP: Dose-Normalized (DN) Cmax||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|||(ng/mL)/mg||Standard Deviation|Mean
769123|NCT00709124|Secondary|Duration of Mechanical Ventilation||At hospital discharge||||||
764944|NCT00661141|Secondary|Pharmacokinetics (PK) of 4-MP: Maximum Plasma Concentration (Cmax)||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.||ng/mL||Standard Deviation|Mean
764945|NCT00661141|Primary|Number of Participants With Adverse Events (AEs), Serious AEs, and AEs Leading to Study Discontinuation|AEs were collected to evaluate the safety and tolerability of oral Antizol with concomitant ethanol administration in particitpants with symptoms of acetaldehyde toxicity associated with altered ethanol metabolism. AE: any untoward medical event that occurs following the first administration of study medication until the study participant’s last study visit, whether or not the event is considered drug related. SAE: an event that meets any of the following criteria: results in death; is life threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect in the offspring of an exposed subject; is medically significant or an important medical event as assessed by investigator or sponsor; is, in the opinion of the investigator, an important medical event.|Study Day 0 through Study Visit Day 7|||Participants|||Count of Participants
764946|NCT00672984|Secondary|Area Under the Steady-state Plasma Concentration-time Curve (AUC) for Guanfacine and Moxifloxacin on Day 6||pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose|PK population||ng.h/ml||Standard Deviation|Mean
764947|NCT00672984|Secondary|Area Under the Steady-state Plasma Concentration-time Curve (AUC) for Guanfacine and Moxifloxacin on Day 1||pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose|PK population||ng.h/ml||Standard Deviation|Mean
764948|NCT00672984|Secondary|Time of Maximum Plasma Concentration (Tmax) of Guanfacine and Moxifloxacin on Day 6||pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose|PK population||hours||Standard Deviation|Mean
764949|NCT00672984|Secondary|Time of Maximum Plasma Concentration (Tmax) of Guanfacine and Moxifloxacin on Day 1||pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose|PK population||hours||Standard Deviation|Mean
764950|NCT00672984|Secondary|Maximum Plasma Concentration (Cmax) of Guanfacine and Moxifloxacin on Day 6||pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose|PK population||ng/ml||Standard Deviation|Mean
764951|NCT00672984|Secondary|Maximum Plasma Concentration (Cmax) of Guanfacine and Moxifloxacin on Day 1||pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose|Pharmacokinetic (PK) population consists of all subjects in the safety population (subjects who had taken one dose of study medication and had one follow-up safety assessment completed) who had evaluable concentration-time profiles.||ng/ml||Standard Deviation|Mean
764952|NCT00672984|Primary|Change From Baseline in Electrocardiogram Results (QT) Interval at Tmax on Day 6|QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate (e.g., the faster the heart rate, the shorter the QT interval).|Baseline and Tmax (time of subject-specific maximum plasma concentration)|PD population||msec||Standard Error|Least Squares Mean
764953|NCT00672984|Primary|Change From Baseline in Electrocardiogram Results (QT) Interval at Tmax on Day 1|QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate (e.g., the faster the heart rate, the shorter the QT interval).|Baseline and Tmax (time of subject-specific maximum plasma concentration)|PD population||msec||Standard Error|Least Squares Mean
764954|NCT00672984|Primary|Change From Baseline in Heart Rate (HR) at Tmax on Day 6||Baseline and Tmax (time of subject-specific maximum plasma concentration)|PD population||bpm||Standard Error|Least Squares Mean
764955|NCT00672984|Primary|Change From Baseline in Heart Rate (HR) at Tmax on Day 1||Baseline and Tmax (time of subject-specific maximum plasma concentration)|PD population||bpm||Standard Error|Least Squares Mean
764956|NCT00672984|Primary|Change From Baseline in Electrocardiogram Results (QTcF) at Tmax on Day 6|QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate (e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.|Baseline and Tmax (time of subject-specific maximum plasma concentration)|PD population||msec||Standard Error|Least Squares Mean
764957|NCT00672984|Primary|Change From Baseline in Electrocardiogram Results (QTcF) at Tmax on Day 1|QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate (e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.|Baseline and Tmax (time of subject-specific maximum plasma concentration)|PD population||msec||Standard Error|Least Squares Mean
764958|NCT00672984|Primary|Change From Baseline in Electrocardiogram Results (QTcNi) at Tmax on Day 6|QTcNi is the QT interval using a subject-specific correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate (e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.|Baseline and Tmax (time of subject-specific maximum plasma concentration)|PD population||msec||Standard Error|Least Squares Mean
764959|NCT00672984|Primary|Change From Baseline in Electrocardiogram Results (QTcNi) at Time of Maximum Plasma Concentration (Tmax) on Day 1|QTcNi is the QT interval using a subject-specific correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate (e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.|Baseline, Tmax (time of subject-specific maximum plasma concentration)|"Pharmacodynamic (PD) population consists of all evaluable subjects with no major protocol deviations. Evaluable subjects were defined as subjects who received a Day 6 dose and had Day 6 data for the primary and secondary endpoints for all three periods."||msec||Standard Error|Least Squares Mean
764969|NCT00673049|Primary|Overall Survival|The time from date of randomization to date of death due to any cause. For participants who were alive, overall survival was censored at the last contact.|Baseline, assessed every cycle until disease progression and then every 4 weeks until death, up to 30.65 months|Full (intent-to-treat) analysis set, which included all participants randomized regardless of treatment received.||months||95% Confidence Interval|Median
764960|NCT00673049|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC), Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13) Score at Cycles 2, 3, and Then Every Odd Cycle Starting With Cycle 5, and EOT (21-28 Days After Last Dose)|QLQ-LC13 consists of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The 13 questions comprise 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, other pain, and medicine for pain). Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.|Baseline (Cycle 1 Day 1 predose), Cycles 2, 3 (Day 1), every odd cycle starting with Cycle 5 and EOT (21-28 days after last dose)|This outcome measure was added in Protocol Amendment 3 (28 January 2010). However, data were not collected as the majority of the subjects had already been enrolled prior to this amendment and the study was terminated shortly thereafter (02 March 2010).|||||
764961|NCT00673049|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) at Cycles 2, 3, and Then Every Odd Cycle Starting With Cycle 5 and EOT (21-28 Days After Last Dose)|EORTC QLQ-C30 includes functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions use 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms.|Baseline (Cycle 1 Day 1 predose), Cycles 2, 3 (Day 1), every odd cycle starting with Cycle 5 and EOT (21-28 days after last dose)|This outcome measure was added in Protocol Amendment 3 (28 January 2010). However, data were not collected as the majority of the subjects had already been enrolled prior to this amendment and the study was terminated shortly thereafter (02 March 2010).|||||
764962|NCT00673049|Secondary|Change From Baseline in Euro Quality of Life (EQ-5D)- Health State Profile Utility at Cycles 2, 3, Then Every Other Cycle and EOT (21-28 Days After Last Dose)|EQ-5D is a participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline (Cycle 1 Day 1 predose), Cycles 2, 3 (Day 1), every other cycle and EOT (21-28 days after last dose)|Due to futility, the study was terminated early; therefore EQ-5D data were not analyzed.|||||
764963|NCT00673049|Secondary|Counts of Circulating Tumor Cell (CTC) Expressing Positive Insulin-Like Growth Factor 1 Receptor (IGF-1R)||Baseline, Cycle 2 Day 1 (predose) and EOT (21-28 days after last dose)|Due to futility, the study was terminated early; therefore biomarker results were not analyzed.|||||
764964|NCT00673049|Secondary|Percentage of Participants Reporting Positive for Total Anti-drug Antibodies (ADA)|ADAs are immunogenicity indicators to figitumumab. Participants reporting positive for ADAs are indicated by an endpoint titer of no less than 6.64.|Cycles 1, 2, 4 (predose), End of Treatment ([EOT] 21-28 days after last dose), about 150 days after last figi dose for figi plus erlo group; Cycles 1, 2, 4 (predose), EOT, about 150 days after last figi dose for erlo, then figi group|"Analysis population included all participants treated with figi. Data are combined for figi+erlo and erlo then figi because the objective was to report any participants with positive ADA after exposure to figi regardless of figi administration order, rather comparison of these 2 treatment groups. N=number of participants evaluable."||percentage of participants|||Number
764965|NCT00673049|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) for Figitumumab||Cycle 1 (Day 1 [predose], Day 2 [1 hour after end of infusion] ), Cycles 2, 4, 6 (predose), Cycle 5 (predose, 1 hour after end of infusion) for figi plus erlo group; Cycles 1, 2,4 (predose) for erlo, then figi group|Due to futility, the study was terminated early; therefore pharmacokinetic data were not analyzed.|||||
764966|NCT00673049|Secondary|Maximum Observed Plasma Concentration (Cmax) for Figitumumab||Cycle 1 (Day 1 [predose], Day 2 [1 hour after end of infusion] ), Cycles 2, 4, 6 (predose), Cycle 5 (predose, 1 hour after end of infusion) for figi plus erlo group; Cycles 1, 2,4 (predose) for erlo, then figi group|Due to futility, the study was terminated early; therefore pharmacokinetic data were not analyzed.|||||
764967|NCT00673049|Secondary|Percentage of Participants With Objective Response|Percentage of participants with objective response (OR) based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. CR are defined as complete disappearance of all lesions (target and/or non target). PR are those with at least 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Baseline, 6, 9, 12, 15, 18 weeks after randomization, thereafter assessed every 6 weeks until disease progression during treatment (or every 8 weeks until disease progression during off-treatment), up to 29.7 months|Full (intent-to-treat) analysis set, which included all participants randomized regardless of treatment received.||percentage of participants||95% Confidence Interval|Number
764968|NCT00673049|Secondary|Progression Free Survival (PFS)|Time from randomization to date of first documentation of progression or death due to any cause, whichever came first. Participants last known to be alive and progression-free, who had a baseline and at least 1 on-study disease assessment, were censored at last disease assessment verifying lack of progression. Progression was determined by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, as a 20% increase in the sum of the longest diameter of target lesions, or target lesions over nadir, unequivocal progression of non-target disease, or the appearance of new lesions.|Baseline, 6, 9, 12, 15, 18 weeks after randomization, thereafter assessed every 6 weeks until disease progression during treatment (or every 8 weeks until disease progression during off-treatment), up to 29.7 months|Full (intent-to-treat) analysis set, which included all participants randomized regardless of treatment received.||months||95% Confidence Interval|Median
764970|NCT00673075|Secondary|Left Ventricular Ejection Fraction (LVEF) (%) at Week 18|Left ventricular ejection fraction (LVEF) (%) at Week 18|18 weeks post-treatment|||percentage||Standard Error|Mean
764992|NCT00673231|Secondary|Adjusted Mean Change in Fasting Plasma Glucose (FPG)|To examine whether treatment with dapagliflozin in combination with insulin is superior in reducing Fasting Plasma Glucose (FPG) as compared to placebo added to insulin treatment after 24 weeks of treatment, excluding data after insulin up-titration.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values||mg/dL||95% Confidence Interval|Least Squares Mean
764993|NCT00673231|Secondary|Proportion of Participants With Calculated Mean Daily Insulin Dose Reduction|To examine whether treatment with dapagliflozin in combination with insulin leads to higher percentage of participants with calculated mean daily insulin dose reduction from baseline to week 24 (i.e. reduction >= 10%) as compared to placebo added to insulin treatment.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values||Percentage of participants||95% Confidence Interval|Least Squares Mean
764994|NCT00673231|Secondary|Adjusted Mean Change in Calculated Mean Daily Insulin Dose|To examine whether treatment with dapagliflozin in combination with insulin leads to a lower absolute calculated mean daily insulin dose as compared to placebo added to insulin treatment alone, from baseline to week 24, including data after insulin up-titration.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values||IU/day||95% Confidence Interval|Least Squares Mean
764995|NCT00673231|Secondary|Adjusted Mean Change in Body Weight|To examine whether treatment with dapagliflozin in combination with insulin is superior in reducing body weight or causing less weight gain as compared to placebo added to insulin treatment after 24 weeks of treatment (LOCF), excluding data after insulin up-titration.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values||kg||95% Confidence Interval|Least Squares Mean
764996|NCT00673231|Primary|Adjusted Mean Change in HbA1c Levels|To assess the efficacy of 2.5 mg, 5 mg and 10 mg dapagliflozin compared to placebo as add-on therapy to insulin in improving glycaemic control in participants with type 2 diabetes who have inadequate glycaemic control on ≥ 30 IU injectable insulin daily for at least 8 weeks prior to enrolment, as determined by the change in HbA1c levels from baseline to Week 24, excluding data after insulin up-titration.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values||Percent||95% Confidence Interval|Least Squares Mean
764997|NCT00673257|Primary|Population Estimates for Daunorubicinol Volume of Distribution|Pharmacokinetic parameters of Daunorubicin hydrochloride will be analyzed, samples were drawn according to the following schedule: prior to the drug infusion, at the midpoint of the infusion if infusion is ≥ 30 min in duration, end of infusion and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 (when feasible) hours after the end of the infusion. Samples will also be collected at 24, 48, and 72 (when feasible) hours after the end of the infusion. The concentration time data will be analyzed by model dependent and model-independent means. Pharmacokinetic data will be analyzed using ADAPT II software (Biomedical Simulations Resource, University of Southern California). Mean volume of distribution will be assessed.|prior to drug infusion, midpoint, and end of infusion. Also 0.5,1,1.5,2,3,4,6,8 and 12 hours after end of infusion.|There were 107 patients enrolled, 4 participants withdrew consent and there was 1 participant with insufficient specimen. 4 other participants were not analyzed as all samples time points were required for analysis and were not available.||Liter||Standard Deviation|Mean
764998|NCT00673257|Primary|Population Estimates for Daunorubicinol Clearance|Pharmacokinetic parameters of Daunorubicin hydrochloride will be analyzed, samples were drawn according to the following schedule: prior to the drug infusion, at the midpoint of the infusion if infusion is ≥ 30 min in duration, end of infusion and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 (when feasible) hours after the end of the infusion. Samples will also be collected at 24, 48, and 72 (when feasible) hours after the end of the infusion. The concentration time data will be analyzed by model dependent and model-independent means. Pharmacokinetic data will be analyzed using ADAPT II software (Biomedical Simulations Resource, University of Southern California). Mean Daunorubicin hydrochloride Clearance will be assessed.|prior to drug infusion, midpoint, and end of infusion. Also 0.5,1,1.5,2,3,4,6,8 and 12 hours after end of infusion.|There were 107 patients enrolled, 4 participants withdrew consent and there was 1 patient with insufficient specimen. 4 other participants were not analyzed as all sample time points were required for analysis and were not available.||L/m2/hr||Standard Deviation|Mean
764999|NCT00673257|Secondary|Relationship Between Pharmacokinetics, Renal and Hepatic Function, and Complete Blood Count|Multivariate analysis of the data will also be performed. Assess the significance of the relationship between the following characteristics: BMI, BSA, ALT, bilirubin, age, gender, and ethnicity, and daunomycin PK parameters.|Length of study||||||
765000|NCT00673712|Secondary|Hospital Length of Stay|time (days) from date of admission to discharge|primary admission|all randomized subjects||days||Standard Deviation|Mean
765001|NCT00673712|Secondary|Surgical Site Infection|surgical site infection diagnosed within 30 days post surgery|30 days postoperative|all randomized subjects||participants|||Number
765002|NCT00673712|Primary|Hospital Acquired Pneumonia|Pneumonia diagnosed during hospitalization|30 days postoperative|all randomized subjects||participants|||Number
765003|NCT00673738|Secondary|Overall Response Rate (ORR)|ORR = Complete Response (CR) + Partial Response (CR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Complete Response: Disappearance of all target lesions; Partial Response: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|Up to 36 months|All participants||percentage of participants||95% Confidence Interval|Number
765004|NCT00673738|Secondary|Median Overall Survival (OS)|Overall survival is defined as the time from randomization until death from any cause.|Up to 36 months|All participants||months||95% Confidence Interval|Median
765005|NCT00673738|Primary|Median Progression Free Survival (PFS)|Progression Free Survival is defined as the interval between the date of the first cetuximab administration and the date of objective progression of disease. Progression was evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria. Progressive Disease (PD): Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|Up to 36 months|All participants||months||95% Confidence Interval|Median
765006|NCT00673764|Secondary|Functional Blink Rate Time (Time Between Blinks)|Measures time in seconds between normal blinks. Performed at 15 minutes, 45 minutes, and 90 minutes post-dose. Longer blink rate time correlates with improved visual performance.|15 minutes, 45 minutes, and 90 minutes post-dose|||seconds||Standard Deviation|Mean
765007|NCT00673764|Primary|Time at Best Corrected Visual Acuity|Measuring length of time patient can maintain their best vision while completing a computer task. Performed at 15 minutes, 45 minutes, and 90 minutes post-dose. Corrected visual acuity means the patient can wear glasses or contacts if needed such that the measure is performed with the patient seeing the best that they can.|15 minutes, 45 minutes, and 90 minutes post-dose|||seconds||Standard Error|Median
765008|NCT00673816|Secondary|Change in Retinal Angioma Leakage From Baseline to Week 36|"Leakage of the retinal angioma was calculated after manually outlining the inner and outer borders of the subretinal fluid packet in the optical coherence tomography (OCT) images using the Edit Segmentation function of the Cirrus HD-OCT software. In cases where a pigment epithelial detachment was present, the volume of the pigment epithelial detachment was included in the calculation of leakage volume."|Baseline and 36 Weeks||||||
765009|NCT00673816|Secondary|Change in Retinal Thickness From Baseline to Week 36|Retinal thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|Baseline and 36 Weeks|||µm|||Number
765010|NCT00673816|Primary|Change in Best Corrected Visual Acuity (BCVA) From Baseline to Week 36|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 36 Weeks|||ETDRS Letters|||Number
765011|NCT00673855|Primary|Drop Comfort Upon Instillation|Drop comfort grading scale is a scale from 0 to 9, with 0 meaning most comfortable and 9 meaning most uncomfortable.|Three minutes|||Units on a scale||Standard Deviation|Mean
765012|NCT00673881|Primary|Total Cholesterol|Mean Change in total cholesterol from baseline to End-of-treatment (Day 95)|12 weeks|||mg/dL||Standard Deviation|Mean
765013|NCT00673881|Secondary|Endogenous Bile Acid Excretion|Change in endogenous bile acid excretion from baseline to end-of-treatment|12 weeks||||||
765014|NCT00673881|Secondary|Neutral Sterol Endogenous Excretion|Change in neutral sterol endogenous excretion from baseline to end-of-treatment|12 weeks||||||
765015|NCT00673881|Secondary|Change in Bile Acid Excretion|Change in bile acid excretion from baseline to end-of-treatment|Baseline to 12 weeks||||||
765016|NCT00673881|Secondary|Change in Neutral Sterol Excretion|The excretion rate of fecal neutral and acidic sterols was measured as mg/day, for each individual three times during the 10 day period following the isotope infusions at baseline and end-of-treatment.|baseline to 12 weeks||||||
765017|NCT00673881|Secondary|Percent Change in de Novo Cholesterol Synthesis|Plasma DNC was measured three times from blood draws on the 3 visits in the 10 day period following the isotope infusion at baseline and again at end-of-treatment at 12 weeks, and expressed in percent. Change from baseline to end-of-treatment expressed as percent.|Baseline to 12 weeks||||||
765018|NCT00673881|Secondary|Change in Plasma Cholesterol Ester Fractional Catabolic Rate (FCR)|Change in FCR from baseline to end-of-treatment (12 weeks)|Baseline to 12 weeks||||||
765019|NCT00673881|Secondary|Plasma Cholesterol Efflux|Change in efflux rate from baseline to end-of-treatment. The efflux rate of cholesterol from peripheral tissues into the plasma was measured as mg/kg/hr. An IV infusion of [13C2] cholesterol mixed in 10% Intralipid® or Liposyn® and 10 % ethanol was given piggy-backed into normal saline over 24 hours. This was used to determine rate of appearance (Ra) cholesterol, measured by dilution of infused [13C2] cholesterol during the plateau phase of plasma enrichment (approximately the last 4 hours of the infusion), as well as to provide the plasma cholesterol traced into biliary sterols.|12 weeks||||||
765020|NCT00673881|Primary|Mean Change in High Density Lipoprotein Cholesterol|Mean change in plasma high density plasma lipoprotein cholesterol (HDL-C)baseline (average Day 0, 1 10) to end-of-treatment (12 weeks treatment,Day 95)|Baseline to 12 weeks|||mg/dL||Standard Deviation|Mean
765021|NCT00673881|Primary|Mean Change in Plasma Triglycerides|Change in plasma triglyceride, baseline (average Day 0, 1 10) to end-of-treatment (12 weeks treatment,Day 95)|baseline to 12 weeks|per protocol||mg/dL||Standard Deviation|Mean
765022|NCT00673881|Primary|Mean Change in Calculated Low Density Lipoprotein Cholesterol|Mean change in calculated LDL, baseline (average Day 0, 1 10) to end-of-treatment (12 weeks treatment,average Day 95)|baseline to 12 weeks|||mg/dL||Standard Deviation|Mean
765023|NCT00673933|Secondary|Erythema Score (Mild and Moderate)1 Day After First Treatment|Patients with mild or moderate erythema 1 day after first treatment.|1 day after 1st treatment and baseline|ITT||percentage of participants|||Number
765024|NCT00673933|Secondary|Erythema Score (Mild and Moderate)Immediately After Second Treatment|Patients with mild or moderate erythema after second treatment.|Immediately after second treatment, 2 weeks after baseline|ITT||percentage of participants|||Number
765025|NCT00673933|Secondary|Change in Noninflammatory Lesion Counts From Baseline||4 weeks after last treatment, 6 weeks after baseline|ITT||lesion count||Standard Deviation|Mean
765026|NCT00673933|Secondary|Change in Inflammatory Lesion Counts From Baseline||4 weeks after last treatment, 6 weeks after baseline|ITT||lesion count||Standard Deviation|Mean
765027|NCT00673933|Secondary|Erythema Score (Mild and Moderate)Immediately After First PDT|Patients with mild or moderate erythema after first treatment at baseline.|Immediately after treatment at baseline|ITT||percentage of participants|||Number
765028|NCT00673933|Primary|Proportion of Patients With Moderate to Severe Hypopigmentation and Hyperpigmentation Assessed After Treatment||4 weeks after last treatment, 6 weeks after baseline|||participants|||Number
765029|NCT00673959|Primary|Drop Comfort Upon Instillation|Drop comfort grading scale is a scale from 0 to 9, with 0 meaning most comfortable and 9 meaning most uncomfortable.|upon instillation|||Units on a scale||Standard Deviation|Mean
765030|NCT00674115|Primary|Change From Baseline in Median 24-hour Intragastric pH on the 7th Day of Drug Administration|The change from Baseline in median pH was calculated as: median pH on Day 7 minus median pH at Baseline. PH measures how acidic or basic a substance is. The pH scale ranges from 0 to 14. A pH of 7 is neutral. A pH less than 7 is acidic. A pH greater than 7 is basic.|Baseline and 7 days|25 participants in each arm had good quality tracings and were included in the efficacy analysis.||pH scale||Full Range|Median
765031|NCT00674128|Primary|Reported Here Are the Number of Participants With Devices That Developed Infection||Within 3 months after surgery.|||participants|||Number
765038|NCT00674206|Secondary|Overall Survival From Time of Study Entry|"The number of weeks patient survived from the time of patient entry. The time frame reflects the time the first patient was entered into the study to the time till the last patient survived.
Note: Not all patients started the study at the same time so the time frame is different from the full range.
The full range reflects the least number of weeks a patient survived to the most number of weeks a patient survived."|132 weeks|||Weeks||Full Range|Median
765039|NCT00674206|Primary|Number of Participants With Complete Response, Partial Response, Progressive Disease and Stable Disease.|"A sum of the longest diameter(LD) for all target lesions will be calculated and reported as the baseline sum LD.
Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Progressive Disease (PD):At least a 20% increase in the sum of the LD of target lesions.
Stable Disease (SD):Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started."|8 weeks|||participants|||Number
765040|NCT00674323|Secondary|Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) of the Study Eye at Month 6|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increase in the VA score indicates improvement in visual acuity.|Baseline and Month 6|Full Analysis Set (FAS) included all patients randomized that received at least 1 application of study drug and had at least 1 post-baseline assessment of ICGA. LOCF was utilized.||Letters||Standard Deviation|Mean
765041|NCT00674323|Secondary|Mean Change From Baseline in Central Retinal Thickness Measured by Optic Coherence Tomography (OCT)|High resolution 6 meridian scans were performed to measure central retinal thickness.|Baseline and Month 6|Full Analysis Set (FAS) included all patients randomized that received at least 1 application of study drug and had at least 1 post-baseline assessment of ICGA. LOCF was utilized.||micrometers||Standard Deviation|Mean
765042|NCT00674323|Secondary|Number of Participants With at Least One Complete Polyp Regression During 6 Months Assessed by ICGA|Indocyanine green angiography (ICGA) assessments were performed using the Heidelberg Retinal Angiography 2 (HRA2) machine to measure the Total Lesion Area and the degree of polyp regression. Complete regression was defined as no polyps seen on the imaging.|Baseline through end of study (6 months)|Full Analysis Set (FAS) included all patients randomized that received at least 1 application of study drug and had at least 1 post-baseline assessment of ICGA. Last Observation Carried Forward (LOCF) was utilized.||Participants|||Number
765043|NCT00674323|Primary|Number of Participants With Complete Regression (CR) of Polyps Measured by Indocyanine Green Angiography (ICGA)|Indocyanine green angiography (ICGA) assessments were performed using the Heidelberg Retinal Angiography 2 (HRA2) machine to measure the Total Lesion Area and the degree of polyp regression. Complete regression was defined as no polyps seen on the imaging.|Month 6|Full Analysis Set (FAS) included all patients randomized that received at least 1 application of study drug and had at least 1 post-baseline assessment of ICGA. Last Observation Carried Forward (LOCF) was utilized.||Participants|||Number
765096|NCT00674739|Primary|Proportion of Subjects With Complete Clearance of All Warts (Both Presented at Baseline and Newly Emerged Warts) at End of Study|Proportion of subjects with complete clearance of all warts (both presented at Baseline and newly emerged warts) at End of Study. Primary analysis performed on the Intent to Treat population with imputation (Last Observation Carried Forward)for missing data points.|Up to 16 weeks|Intention to treat||participants||95% Confidence Interval|Number
765097|NCT00674739|Secondary|Safety Variables Include Adverse Reactions (AEs), Local Skin Reactions (LSRs), and Number of Subjects Who Took Rest Periods During the Treatment Period.|"Local skin reactions in the treatment and/or immediate surrounding area were clinically identified as: erythema, edema, weeping/exudate, flaking/scaling/dryness, and erosion/ulceration. LSRs were visually assessed by investigator at each visit.
Rest period was a temporary interruption of dosing dur to intolerable LSRs."|Up to 16 weeks|||participants|||Number
765083|NCT00674609|Secondary|Memory 0-10 Numerical Rating Scale|"The memory NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate how well you are able to remember what you have done in the past 24 hours? where 0 = very well and 10 = not at all. A negative value indicates an improvement in memory score from baseline."|2 weeks: baseline - end of week 2 (last 3 days of treatment)|All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population, used for this analysis.||units on a scale||Standard Deviation|Mean
765074|NCT00674466|Secondary|Reduction in Fasting Body Weight From Baseline|Change from baseline|Screening and Day 85|Modified Intent-to-Treat Population||kg||Standard Deviation|Mean
765075|NCT00674466|Secondary|Reduction in Fasting Plasma Glucose From Baseline|Change from baseline|Screening and Day 85|Modified Intent-to-Treat Population||mg/dL||Standard Deviation|Mean
765076|NCT00674466|Primary|Reduction of HbA1c From Baseline|Change from baseline|Screening and Day 85|Modified Intent-to-Treat Population||Percent (%)||Standard Deviation|Mean
765077|NCT00674492|Primary|Attributes of Treatment Experience|Four basic reasons for persisting in antiviral treatment were identified: cure the disease, concern about diminishing time to act (avoid bad end), demonstation of personal strength, and redemption for past behavior.|Zero to five years since ending treatment.|||participants|||Number
765078|NCT00674609|Primary|The Consumption of Escape Analgesic Medication.|Subjects recorded their use of escape medication each day on their diary card.|2 weeks: baseline - end of week 2 (last 3 days of treatment)|The primary population for this analysis was the intention-to-treat (ITT) population, which included all randomised subjects who received at least 1 dose of study medication and had on-treatment efficacy data. The primary analysis escape medication usage i.e. the number of days escape medication was used did not include any covariates.||tablets per day||Standard Deviation|Mean
765079|NCT00674609|Secondary|Brief Pain Inventory Short Form|The BPI-SF is a 14-item questionnaire that asks patients to rate pain over the prior week and the degree to which it interferes with activities on a 0 to 10 scale, where 0=no pain and 10=pain as bad as you can imagine. Severity is measured as worst pain, least pain, average pain, and pain right now. The severity composite score was calculated as the arithmetic mean of the four severity items(range 0-10). The minimum value is zero and maximum is 10. A higher score represents a poor outcome.|End of 2 weeks|All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population, used for this analysis.||units on a scale||Standard Deviation|Mean
765080|NCT00674609|Secondary|EORTC Quality of Life Questionnaire (EORTC-QLQC30)|Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), a core cancer-specific questionnaire containing 30 items on patients' functioning, global quality of life, disease- and treatment related symptoms. Higher scores indicate a greater degree of symptoms, min.: 0, Max.: 100|2 weeks; baseline and end of treatment (2 weeks)|All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population, used for this analysis.||units on a scale||Standard Deviation|Mean
765081|NCT00674609|Secondary|Concentration 0-10 Numerical Rating Scale|"The concentration NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate how well have you been able to concentrate throughout the day e.g. when reading a newspaper? where 0 = very well and 10 = not at all. A negative value indicates an improvement in concentration score from baseline."|2 weeks: baseline - end of week 2 (last 3 days of treatment)|All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population, used for this analysis.||units on a scale||Standard Deviation|Mean
765082|NCT00674609|Secondary|Appetite 0-10 Numerical Rating Scale|"The appetite NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate how your appetite has been throughout the day? where 0 = very good and 10 = very poor. A negative value indicates an improvement in appetite score from baseline."|2 weeks: baseline - end of week 2 (last 3 days of treatment)|All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population, used for this analysis.||units on a scale||Standard Deviation|Mean
765304|NCT00670241|Secondary|The Percentage Change in PASI From Baseline to Week 8|PASI is Psoriasis Area and Severity Index and is based on the investigator's assessment of extent and severity of the disease. It can range from 0 (best) to 64.8 (worst).|Baseline, Week 4 and 8|||Percent change in PASI score|||Number
765084|NCT00674609|Secondary|Nausea 0-10 Numerical Rating Scale|"The nausea NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate how sick you felt throughout the day? where 0 = not sick at all and 10 = very sick. A negative value indicates an improvement in nausea score from baseline."|2 weeks; baseline - end of week 2 (last 3 days of treatment)|All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population, used for this analysis.||units on a scale||Standard Deviation|Mean
765085|NCT00674609|Secondary|Sleep Disturbance 0-10 Numerical Rating Scale|"The sleep disruption NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate how your pain disrupted your sleep last night? where 0 = did not disrupt sleep and 10 = completely disrupted (unable to sleep at all). A negative value indicates an improvement in sleep disruption score from baseline."|2 weeks: baseline to end of week 2 (last 3 days of treatment)|All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population, used for this analysis.||units on a scale||Standard Deviation|Mean
765086|NCT00674609|Primary|The Change in Mean Pain Numerical Rating Scale (NRS) Score From Baseline to the End of the Treatment.|"The pain NRS was complete at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain due to cancer. A negative value indicates an improvement in pain score from baseline."|2 weeks: baseline - end of week 2 (last 3 days of treatment)|All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population. This population was used for the primary analysis. Presented below is the adjusted mean change from baseline in mean pain NRS.||units on a scale||Standard Deviation|Mean
765087|NCT00674622|Secondary|Pain Threshold on Dolorimetry|Pressure pain threshold (PPT) has been noted to correlate with pain and disability associated with LE. PPT was determined by applying pressure with a digital algometer over the area of maximal tenderness corresponding with the common extensor tendon area. Only 1 determination was obtained as the 1st application of pressure can lower the pain threshold for subsequent testing.|6 and 12 weeks post-intervention|||Pounds||Standard Deviation|Mean
765088|NCT00674622|Secondary|Nirschl Pain Phase Scale|The Nirschl Pain Phase Scale (NPPS), which has been used to describe functional impairment related to tendinopathies such as lateral epicondylitis. This scale provides a global rating of impairment associated with sports and musculoskeletal injuries. A rating from 0-7 describes the phase of overuse injuries, with Phase 0 noting “No stiffness or soreness after activity” and Phase 7 corresponding with “Pain that also disrupts sleep consistently. Pain is aching in nature and intensifies with activity”. It was used as an indication of severity for entry into the study and as the criterion for treatment response.|6 and 12 weeks post-intervention|||units on a scale||Standard Deviation|Mean
765089|NCT00674622|Secondary|Grip Strength|Maximal pain-free grip strength has been used as a physical correlate of disability associated with LE. Grip strength was obtained using a Jamar Dynamometer set in the 2nd position. 3 trials were recorded and the average pain-free grip strength was noted.|6 weeks and 12 weeks post-intervention|||pounds||Standard Deviation|Mean
765090|NCT00674622|Secondary|QuickDASH|The QuickDASH is an abbreviated form of the rating scale DASH or Disabilities of the Arm, Shoulder, & Hand. This is a self-report rating of function for individuals with problems of the upper extremity. The Institute for Work and Health, in collaboration with the American Academy of Orthopaedic Surgeons developed a self-report questionnaire “Disabilities of the Arm, Shoulder, & Hand”. It is seen as a valid and reliable measure of upper extremity functional impairment, is in widespread use in the States and abroad, having been translated into multiple languages and has been used for studies on LE. 11 items are scored on this self-rating instrument on a 1-5 Likert scale with higher score reflecting greater disability. The scores are averaged and then converted to a 100 point scale (0-100), with higher score reflecting greater disability.|6 weeks and 12 weeks post-intervention|||units on a scale||Standard Deviation|Mean
765091|NCT00674622|Primary|McGill Pain Questionnaire|This is a pain severity rating. 15 adjectival descriptors of pain are scored on a 0-3 scale for a total score of 0-45 with a high score reflecting greater pain severity.|6 weeks and 12 weeks post intervention|||units on a scale||Standard Deviation|Mean
765092|NCT00674661|Primary|Mean Change From Baseline in Maximum Keratometry (Kmax)|The primary efficacy parameter was corneal curvature, as measured by maximum keratometry (Kmax) in the study eyes. Study success was defined as a difference of ≥1 D in the mean change in Kmax from baseline to 12 months between the CXL group and control group. Keratometry was measured manually and by pentacam.|baseline,12 months|||diopters||Standard Deviation|Mean
765093|NCT00674700|Secondary|Average Rhinitis Total Symptom Score (ARTSS)|The Rhinitis Total Symptom Score (RTSS) evaluates the presence and severity of the 4 rhinitis symptoms: sneezing, rhinorrhoea, nasal pruritus and nasal congestion (absence of symptom (0), mild symptom (1), moderate symptom (2), severe symptom (3)). It ranges from 0 to 12, the higher the score the more severe the rhinitis.|Last 3 months of Year 1|The Full Analysis Set included all participants who received at least one dose of the investigational product and had at least one Adjusted Symptom Score evaluation in the year.||Units on a scale (range: 0 to 12)||Standard Error|Least Squares Mean
765094|NCT00674700|Primary|Average Adjusted Symptom Score (AAdSS) During the Year 1 Primary Period|"The AAdSS is derived from the daily Rhinoconjunctivitis Total Symptom Scores (RTSS), based on the severity of the 4 rhinitis symptoms: sneezing, rhinorrhoea, nasal pruritus and nasal congestion, each graded on a 4-point scale (0-3; 0: absent, 1: mild, 2: moderate, 3: severe).
It ranges from 0 to 12, the higher the score the more severe the rhinitis."|Last 3 months of Year 1|The Full Analysis Set included all participants who received at least one dose of the investigational product and had at least one Adjusted Symptom Score evaluation in the year.||Units on a scale (range: 0 to 12)||Standard Error|Least Squares Mean
765095|NCT00674739|Secondary|Treatment Related Adverse Events|Numbers of subjects in each treatment group reporting one or more adverse events|Up to 16 weeks|Patients with adverse events considered probably related or related to the administration of the product.||Participants|||Number
765098|NCT00674765|Primary|TimeLine Follow Back (TLFB) to Measure Percent Heavy Drinking Days During the Medication/Placebo Phase|The total number of heavy drinking days per Arm was divided by total number of days, multiplied by 100%, to report the percent days of heavy drinking per Arm.|12 weeks|||percent days of heavy drinking|||Number
765099|NCT00674817|Secondary|Time to Last Quantifiable Plasma Concentration (Tlast) of GSK961081 Over Period Determined Directly From the Concentration-time Data|Tlast is the time to last quantifiable plasma concentration of GSK961081 over period determined directly from the concentration-time data|Up to 82 days|PK population. All participants were present for the analysis; however, there were few participants for whom parameter could not be derived because of non-quantifiable concentration. Data is presented for the participants available at the time of assessment.||hours||Full Range|Median
765100|NCT00674817|Secondary|Time to Maximum Plasma Concentration (Tmax) of GSK961081 Over Period Determined Directly From the Concentration-time Data|Tmax is the time to maximum plasma concentration of GSK961081 over period determined directly from the concentration-time data|Up to 82 days|PK population. All participants were present for the analysis; however, there were few participants for whom parameter could not be derived because of non-quantifiable concentrations. Data is presented for the participants available at the time of assessment.||Hours||Full Range|Median
765101|NCT00674817|Secondary|Maximum Plasma Concentration (Cmax) of GSK961081 Over Period Determined Directly From the Concentration-time Data|Cmax is the Maximum observed concentration of GSK961081 determined directly from the concentration-time data. A large proportion of Cmax values were reported as not countable (NC ) at the GSK961081 400 micrograms (ug) dose level, therefore only limited summaries were calculated. Logarithmic transformed values are presented. Cmax was imputed with 1/2 lowest limit of quantification (LLQ), where LLQ was 25 picograms per milliliter (pg/mL).|Up to 82 days|PK population. All participants were present for analysis, however, there were few participants for whom parameter could not be derived because of non-quantifiable concentrations.||pg/mL||Geometric Coefficient of Variation|Geometric Mean
765102|NCT00674817|Secondary|Area Under Plasma Concentration Time Curve (AUC) of GSK961081 to the Last Quantifiable Concentration|AUC(0-t) is the area under plasma concentration time curve of GSK961081 to the last quantifiable concentration. This parameter was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. A large proportion of AUC(0-t) and Cmax values were reported as not countable (NC) at the GSK961081 400 micrograms (ug) dose level, therefore only limited summaries were calculated. Logarithmic transformed values are presented. AUC(0-t) imputed with 1/2 lowest observed AUC(0-t), where lowest AUC(0-t) was 56.46 hour picograms per milliliter (h*pg/mL).|Up to 82 days|Pharmacokinetic (PK) population included participants in the ‘All Subjects’ population for whom a PK sample was obtained and analyzed following GSK961081 dosing. All participants were available at the time of analysis; however, for few participants, parameter cannot be derived because of non-quantifiable concentrations.||h*pg/mL||Geometric Coefficient of Variation|Geometric Mean
765103|NCT00674817|Secondary|Time to Maximum Change From Baseline (Pre-dose on Day 1) for QTc(B), QTc(F), Heart Rate, Systolic BP, Glucose in Supine Position and Time to Minimum Change From Baseline for Potassium and Diastolic BP in Supine Position|Analysis of QT (B) or QTc (F) interval during ECG (taken in supine position) was performed using Bazett's method and Fridericia's method, respectively. Heart rate, BP, potassium, and glucose were measured in supine body position. Change from baseline is the value at indicated time point minus the value at Baseline. Weighted means are considered as LS mean values while presenting the data.|From dosing until 4 hours (0-4h)|Modified Per Protocol population. n=data is presented for the participants available at the time of assessment.||hours||Full Range|Median
765104|NCT00674817|Secondary|Minimum Change From Baseline (Pre-dose on Day 1) in Potassium Over 4 and 27 Hours and Weighted Mean Change From Baseline in Potassium Over 4 Hours|Maximum change (MC) from Baseline (BL) and weighted mean change (WMC) from baseline in potassium (K) were analyzed. Change from Baseline is the value at indicated time point minus the value at Baseline. Weighted means are considered as LS mean values while presenting the data.|0-4h and 0-27h for maximum change and 0-4 h for weighted mean change|Modified Per Protocol population. Only those participants available at the specified time points were analyzed.||Millimoles per Liter||Standard Error|Least Squares Mean
765105|NCT00674817|Secondary|Maximum Change From Baseline (Pre-dose on Day 1) in Glucose Over 4 and 27 Hours and Weighted Mean Change From Baseline in Glucose Over 4 Hours|Maximum change (MC) from Baseline (BL) and weighted mean change (WMC) from baseline in glucose (GLU) were analyzed. Change from Baseline is the value at indicated time point minus the value at Baseline. Weighted means are considered as LS mean values while presenting the data.|0-4h and 0-27h for maximum change and 0-4 h for weighted mean change|Modified Per Protocol population. Only those participants available at the specified time points were analyzed.||Millimoles per Liter||Standard Error|Least Squares Mean
765106|NCT00674817|Secondary|Minimum Change From Baseline (Pre-dose on Day 1) in Supine Diastolic Blood Pressure (DBP) Over 4 and 27 Hours and Weighted Mean Change From Baseline in Supine DBP Over 4 Hours|Diastolic blood pressure (DBP) values were recorded in supine position. Change from baseline is the value at indicated time point minus the value at Baseline. Adjusted or maximum change/(MC) and weighted mean change (WMC) are considered as LS mean change values while presenting the data .|0-4h and 0-27h for maximum change and 0-4 h for weighted mean change|Modified Per Protocol population. Only those participants available at the specified time points were analyzed.||Millimeters of mercury||Standard Error|Least Squares Mean
765107|NCT00674817|Secondary|Maximum Change From Baseline (Pre-dose on Day 1) in Supine Systolic Blood Pressure (SBP) Over 4 and 27 Hours and Weighted Mean Change From Baseline in Supine SBP Over 4 Hours|Systolic blood pressure (SBP) values were recorded in supine position. Change from baseline is the value at indicated time point minus the value at Baseline. Adjusted or maximum change/ (MC) and weighted mean change (WMC) are considered as LS mean change values while presenting the data.|0-4h and 0-27h for maximum change and 0-4 h for weighted mean change|Modified Per Protocol population. Only those participants available at the specified time points were analyzed.||Millimeters of mercury||Standard Error|Least Squares Mean
765108|NCT00674817|Secondary|Weighted Mean Change From Baseline (Pre-dose on Day 1) in Heart Rate in Supine Position From 0 to 4 Hours|Heart rate was recorded in supine position. Change from baseline is the value at indicated time point minus the value at Baseline. Weighted means are considered as LS mean values while presenting the data.|From dosing until 4 hours (0-4h)|Modified Per Protocol population. Data is presented for the participants available at the time of assessment.||Beats per minute||Standard Error|Least Squares Mean
765149|NCT00675428|Primary|Objective Response Rate (ORR)|Response rates were classified according to the International Uniform Response Criteria for Multiple Myeloma (Durie et al, 2006).|Day 1 up to Month 6|ORR was not calculated because the study was terminated early.|||||
765109|NCT00674817|Secondary|Maximum Change From Baseline (Pre-dose on Day 1) in Supine Heart Rate From 0 to 4 Hours and From 0 to 27 Hours.|Heart rate was measured in supine position. Change from baseline is the value at indicated time point minus the value at Baseline. Adjusted means are considered as LS mean values while presenting the data.|From dosing until 4 hours (0-4h) and until 27 hours (0-27 h)|Modified Per Protocol population.||Beats per minute||Standard Error|Least Squares Mean
765110|NCT00674817|Secondary|Weighted Mean Change From Baseline (Pre-dose on Day 1) in QTc(B) in Supine Position From 0 to 4 Hours|Analysis of QT (B) interval during ECG (taken in supine position) was performed using Bazett's method. Change from baseline is the value at indicated time point minus the value at Baseline. Weighted means are considered as LS mean values while presenting the data.|From dosing until 4 hours (0-4h)|Modified Per Protocol population.||msec||Standard Error|Least Squares Mean
765111|NCT00674817|Secondary|Maximum Change From Baseline (Pre-dose on Day 1) in QTc(B) in Supine Position From 0 to 4 Hours and 0 to 27 Hours|Analysis of QT (B) interval during ECG (taken in supine position) was performed using Bazett's method. Change from baseline is the value at indicated time point minus the value at Baseline. Weighted means are considered as LS mean values while presenting the data .|From dosing until 4 hours (0-4h) and 27 hours (0-27h)|Modified Per Protocol population.||msec||Standard Error|Least Squares Mean
765112|NCT00674817|Secondary|Weighted Mean Change From Baseline (Pre-dose on Day 1) in QTc(F) in Supine Position From 0 to 4 Hours|Analysis of QT(F) interval during ECG (taken in supine position) was performed using Fridericia's method. Change from baseline is the value at indicated time point minus the value at Baseline. Weighted means are considered as LS mean values while presenting the data.|From dosing until 4 hours (0-4h)|Modified per protocol population. Only those participants available at the specified time points were analyzed.||msec||Standard Deviation|Least Squares Mean
765113|NCT00674817|Secondary|Maximum Change From Baseline (Pre-dose on Day 1) in QTc (F) in Supine Position From 0 to 27 Hours After Dosing|Analysis of Q T (F) interval during ECG (taken in supine position) was performed using Fridericia's method. Change from baseline is the value at indicated time point minus the value at Baseline. Adjusted means are considered as LS mean values while presenting the data .|From dosing until 27 hours (0-27h)|Modified per protocol population||msec||Standard Deviation|Mean
765114|NCT00674817|Secondary|Maximum Change From Baseline (Pre-dose on Day 1) in QTc (F) in Supine Position From 0 to 4 Hours After Dosing|Analysis of QT (F) interval during ECG (taken in supine position) was performed using Fridericia's method. Change from baseline is the value at indicated time point minus the value at Baseline. Adjusted means are considered as least square (LS) mean values while presenting the data.|From dosing until 4 hours (0-4h)|Modified per protocol population||msec||Standard Deviation|Mean
765115|NCT00674817|Secondary|Number of Participants With Maximum Change From Baseline 12-LED Electrocardiogram (ECG) Findings|Analysis QTc interval of ECG was performed by Bazett's formula (QTc B) and Fridericia's correction (QTc F). Number of participants with abnormal ECG findings were recorded. Any participant with QTc(B) or QTc(F) >500 milliseconds (msec) or uncorrected QT >600 msec (machine or manual over read) was withdrawn from the study. Participants that had right bundle branch block with QTc(B) or QTc(F) >530 msec were also withdrawn from the study.|From dosing until 24h post-dose.|All subjects population||Participants|||Number
765116|NCT00674817|Secondary|Mean Change From Baseline (Pre-dose on Day 1) in Heart Rate Over 27 Hours|Heart rate was considered as a measure of vital sign. Change from baseline is the difference in the blood pressure at the indicated time point minus the Baseline value.|Up to 27 hours post Day 1 dosing|All subjects population. Only those participants available at the specified time points were analyzed.||Beats per minute||Standard Deviation|Mean
765117|NCT00674817|Secondary|Change From Baseline (Pre-dose on Day 1) in Systolic and Diastolic Blood Pressure up to 27 Hours|Change from Baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) was analyzed. Change from baseline is the difference in the blood pressure at the indicated time point minus the Baseline value.|Up to 27 hours post Day 1 dosing|All subjects population. Only those participants available at the specified time points were analyzed.||Millimeters of mercury (mm of Hg)||Standard Deviation|Mean
765118|NCT00674817|Secondary|Number of Participants With Laboratory Abnormalities of Potential Clinical Concern (PCC)|The normal ranges of laboratory parameters were hemoglobin: 130-167 grams per deciliter (g/dL), platelets: 173–383 Giga per liter (GI/L), lymphocytes: 20.1–44.5 %, glucose: 3.8857–6.106 millimoles per liter (mmol/L), creatinine: 44.2–132.6 micromoles per liter (uM/L) , aspartate transaminases (AST): 12–32 international units per liter (IU/L), total bilirubin (TB): 4.275–25.65 uM/L and potassium: 3.4–4.7 mmol/L, respectively. Laboratory values recorded outside the normal range were considered of potential clinical concern (PCC).|Up to 42 days|All subjects population||Participants|||Number
765119|NCT00674817|Secondary|Number of Participants With Adverse Events and Serious Adverse Events|An adverse event (AE) is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious AE (SAE) is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect.|Upto 82 days|All subjects population||Participants|||Number
765120|NCT00674817|Secondary|Maximal Change in Forced Vital Capacity (FVC) in One Second From Pre-dose in Combination With Short Acting Bronchodialator (Salbutamol or Ipratropium Bromide) at 1h, 12h and 24h.|FVC is defined as the amount of air that can be forcibly exhaled from the lungs after a maximum inspiration as measured by spirometry. Adjusted mean has been presented as least square (LS) mean.|Baseline (Pre-dose on Day 1), 1h, 12h, and 24h on Day 1|Modified per protocol population. Only those participants available at the specified time points were analyzed.||Liters||Standard Error|Least Squares Mean
765121|NCT00674817|Primary|Maximal Change in Forced Expiratory Volume in One Second (FEV1) From Baseline (Pre-dose on Day 1) in Combination With Short Acting Bronchodialator (Salbutamol or Ipratropium Bromide) at 1h,12h and 24h.|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second as measured by spirometry. Adjusted mean has been presented as least square (LS) mean.|Baseline (pre-dose on Day 1), 1h, 12h, and 24h on Day 1|Modified per protocol population included the participants who received at least one dose of the study drug where major deviations from the protocol had not occurred. Only those participants available at the specified time points were analyzed.||Liters||Standard Error|Least Squares Mean
765122|NCT00674973|Secondary|Number of Participants With Adverse Events (AEs)|An adverse event (AE) was defined as any untoward medical occurrence in a participant who was administered a study treatment, regardless of whether or not the event had a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment.|Up to 28 days after discontinuation of study drug (up to 30 months)|Safety population included all participants who received at least 1 dose of study medication and had a safety follow-up, whether withdrawn prematurely or not, were included in the safety population.||participants|||Number
765123|NCT00674973|Secondary|Overall Survival|Overall survival was defined as the time from the date of randomization to the date of death, regardless of the cause of death.|From the time of randomization until or death (up to 30 months)|The FAS was defined as all randomized patients. Participants were presented according to the therapy that they were randomized to receive.||months||95% Confidence Interval|Median
765124|NCT00674973|Secondary|Percentage of Participants With Disease Control Rate (DCR)|Disease control rates (DCR) were measured according to RECIST Version 1.0 criteria. Disease control was defined as being a responder or as having stable disease for at least 6 weeks post-randomization. Stable disease was defined as having neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease.|Randomization to Clinical Cutoff: 20 December 2010 (up to 30 months)|The FAS was defined as all randomized patients. Participants were presented according to the therapy that they were randomized to receive.||percentage of participants||95% Confidence Interval|Number
765125|NCT00674973|Secondary|Percentage of Participants With Best Overall Response Rate|Response rate was defined as Complete Response (CR) or Partial Response (PR), according to response evaluation criteria in solid tumors (RECIST) Version 1.0 criteria, for at least 4 weeks at any time during randomized treatment (confirmed response). CR was defined as the disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters of target lesions.|From the time of randomization until progression of disease or death (up to 30 months)|The FAS was defined as all randomized patients. Participants were presented according to the therapy that they were randomized to receive.||percentage of participants||95% Confidence Interval|Number
765126|NCT00674973|Primary|Progression-Free Survival|Progression-free survival (PFS) was defined as the time from the date of randomization to the date of the first occurrence of PD or death whichever occurred first. Participants without event were censored at the date of last tumor assessment where non-progression was documented. Analysis was performed using Kaplan-Meier method.|From the time of randomization until progression of disease or death (up to 30 months)|The Full-Analysis Set (FAS) was defined as all randomized patients. Participants were presented according to the therapy that they were randomized to receive.||weeks||95% Confidence Interval|Median
765127|NCT00674986|Secondary|Glycemic Variability Pre and Post-Prandial Excursions at Each Meal|"Glycemic Variability was evaluated in the STG group for each 3-day set that corresponded to the days the subjects completed the tool before each post-baseline clinic visit. Some parameters used to estimate glycemic variability over the 3-day profile included mean and maximum post-prandial glucose excursions (differences between pre- and post-meal blood glucose levels), mean blood glucose and mean amplitude of glycemic excursion.
The calculation used a Linear mixed model with visit, Month 1 value, gender, age and race (White and Non-White) as fixed effects; and site and subject as random effects."|Month 1, Month 12|Intent to treat population included all enrolled participants who completed the baseline training visit.||mg/dL||Standard Error|Least Squares Mean
765128|NCT00674986|Secondary|Mean Number of Subject Monitored Blood Glucose (SMBG) Tests Per Day|SMBG data for all participants was collected by the glucose meter and were uploaded directly to a web server. The mean number of SMBG tests/day was calculated for the entire study period.|12 Months|Intent to treat population included all enrolled participants who completed the baseline training visit.||Tests/day||Standard Error|Least Squares Mean
765129|NCT00674986|Secondary|Change From Baseline in Confidence in Diabetes Self-Care (CIDS-2)|Participants rated how confident they felt about managing each of 20 diabetes self-care tasks using the CIDS-2 questionnaire. Responses were given on a 5-point scale ranging from 1=not at all confident to 5=completely confident for a total possible score of 20 (worst) to 100 (best). Results were calculated using a Linear Mixed Model with study group, visit, group-by-visit interaction, baseline CIDS-2, gender, age, and race as fixed effects; and site and subject as random effects. A positive change from Baseline indicated improvement.|Baseline, Month 12|Per protocol population included all enrolled participants who completed the baseline training visit, completed at least 4 of 5 clinical visits, and had evaluable HbA1c data at Month 12. The Structured Testing Group also had to have at least 80% of the blood glucose values.||Score on a scale||Standard Error|Least Squares Mean
765130|NCT00674986|Secondary|Change From Baseline in the World Health Organization (WHO-5) Well-being Index|Participants used the WHO-5 to rate their well-being (feeling good and cheerful) for the past 2 weeks using a 6-point scale: 0=At no time to 5=All of the time for a total possible score of 0 (worst) to 100 (best). Results were calculated using a Linear Mixed Model with study group, visit, group-by-visit interaction, baseline WHO-5, gender, age, and race as fixed effects; and site and subject as random effects. A positive change from Baseline indicated improvement.|Baseline, Month 12|Intent to treat population included all enrolled participants who completed the baseline training visit.||Score on a scale||Standard Error|Least Squares Mean
765131|NCT00674986|Secondary|Change From Baseline in the Diabetes Distress Scale (DDS)|Participants rated their level of diabetes distress by answering 17 questions in in the following areas: Regimen-related Distress, Emotional Burden, Diabetes-related Interpersonal Distress and Physician-related Distress (PD) on a 6-point scale: 1=Not a problem to 6=A very serious problem. The Average Total score ranged from 1 (best) to 6 (worst). Results were calculated using a Linear Mixed Model with study group, visit, group-by-visit interaction, baseline DDS, gender, age, and race as fixed effects; and site and subject as random effects. A negative change from Baseline indicated improvement.|Baseline, Month 12|Intent to treat population included all enrolled participants who completed the baseline training visit.||Score on a scale||Standard Error|Least Squares Mean
765305|NCT00670241|Secondary|"Subjects With Controlled Disease According to the Investigator's Global Assessment of Disease Severity at Week 4"||Week 4|||participants|||Number
765306|NCT00670241|Primary|"Subjects With Controlled Disease (Clear or Almost Clear Disease) According to Investigator's Global Assessment of Disease Severity at Week 8"||Week 8|||Participants|||Number
765132|NCT00674986|Secondary|Change From Baseline in Depression Severity (PHQ-8)|The Patient Health Questionnaire-8 (PHQ-8) is an eight-item patient questionnaire to measure the severity of depression disorders over the previous 2 weeks. Each item is rated on a 4-point scale of: 0=not at all to 3=nearly every day. The total score for all items range from 0 (best) to 24 (worst). Results were calculated using a Linear Mixed Model with study group, visit, group-by-visit interaction, baseline PHQ-8, gender, age, and race as fixed effects; and site and subject as random effects. A negative change from Baseline indicated improvement.|Baseline, Month 12|Intent to treat population included all enrolled participants who completed the baseline training visit.||Score on a scale||Standard Error|Least Squares Mean
765133|NCT00674986|Secondary|Number of Visits With Diabetic Medication and/or Lifestyle Change Recommendations|Treatment intensification was assessed at each clinic visit. The physician evaluated the patient and made recommendations of a change in two areas: changes in diabetic medication and/or changes in lifestyle (such as diet, exercise and education.)|12 Months|Intent to treat population included all enrolled participants who completed the Baseline training visit. Participants who dropped out before Month 1 visit were not included in the analysis.||Visits||Standard Deviation|Mean
765134|NCT00674986|Primary|Change From Baseline in Hemoglobin A1c (HbA1c) at Month 12|Blood was collected at Baseline and Month 12 and analyzed at a central laboratory for HbA1c. Results were calculated using a Linear Mixed Model with study group, visit, group-by-visit interaction, baseline HbA1c, gender, age, and race as fixed effects; and site and subject as random effects. A negative change from Baseline indicated improvement.|Baseline, Month 12|Intent to treat population included all enrolled participants who completed the baseline training visit.||Percent||Standard Error|Least Squares Mean
765135|NCT00675103|Secondary|Mean Plasma Uric Acid|This endpoint assessed the change in mean PUA concentration from baseline after the first dose and after the third dose. Mean PUA was calculated from samples collected at 5 timepoints following each of those doses. For example, Mean PUA at Week 3 included 5 timepoints before dose 2 infusion.|Baseline, Week 3 and Week 7|ITT population||mg/dL||Standard Deviation|Mean
765136|NCT00675103|Primary|Adverse Event Profile|Number of participants reporting events|6 months|||Number of participants|||Number
765137|NCT00675259|Secondary|Overall Expression of LZTS1 Before and After Neoadjuvant Therapy as Assessed by Immunohistochemistry|LZTS1 expression in breast cancer cells collected prior to NCT|prior to surgery|LZTS1 expression in breast cancer cells collected prior to NCT was assessed in 27 patients who had evaluable core biopsies.||patients|||Number
765138|NCT00675259|Secondary|Evaluation of Dynamic Contrast-enhanced Magnetic Resonance Imaging in Assessing pCR at Baseline and After 2 Cycles of Neoadjuvant Therapy|Relative angiogenic volume (AV) was defined as the ratio of AV to the geometric volume of the tumor in the breast.|after 2 cycles of therapy|Data only available for 20 of the 28 evaluable patients||ratio||Standard Deviation|Mean
765139|NCT00675259|Primary|Side Effects of Weekly Nab-paclitaxel, Carboplatin and Bevacizumab|Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0|Up to 4 weeks|all grade 3 adverse events||patients|||Number
765140|NCT00675259|Primary|Number of Patients With Pathologic Complete Response (pCR)|pCR was defined as the absence of viable invasive tumor cells in the surgical breast specimen and axillary lymph nodes.|every 4 weeks|Includes patients with triple negative breast cancer and ER+/PR+ breast cancer.||patients|||Number
765141|NCT00675415|Secondary|Proportion of Patients With Oxygen Requirements, Major Hypoxemia, Apnea and Hypoventilation in the Two Arms.||Pre- and intraprocedural measurments||||||
765142|NCT00675415|Secondary|Risk Factors for Apnea Via Univariate and Multivariate Analysis||Pre- and intraprocedural measurments||||||
765143|NCT00675415|Primary|Proportion of Patients With Hypoxemia in the Two Arms||Hypoxemia during ERCP and EUS|||Participants|||Count of Participants
765144|NCT00675428|Secondary|Natalizumab Binding Saturation Of α4 Integrin Sites On Peripheral Blood Mononuclear Cells (PBMC)||Cycle 1: Day 1 (1 hour before infusion and 1 and 24 hours after infusion), Days 8, 15, 22. Cycles 2-5: 1 hour before and 1 hour after infusion). Cycle 6: Day 1 (1 hour before infusion and 1 hour after infusion), Days 8, 15, 22.|Analysis of binding saturation of α4 integrin sites was not performed because the study was terminated early.|||||
765145|NCT00675428|Secondary|Pharmacokinetic (PK) Profile Of Natalizumab|PK modeling, either compartmental or noncompartmental-based, was used to describe serum concentrations. Standard PK parameters estimated include: area-under-the-concentration-time curve (AUC), maximum-observed concentration (Cmax), time-to-reach maximum concentration (Tmax), total body clearance (Cl), volume of distribution (Vd), and elimination half-life (t1/2).|Cycles 1 and 6: Day 1 (before infusion and 0.25, 2, 6 and 24 hours after infusion), Days 8, 15, 22. Cycles 2-5: Day 1 (before infusion and 0.25 hour after infusion)|PK analysis was not performed because the study was terminated early.|||||
765146|NCT00675428|Secondary|Kaplan-Meier Estimates for Duration Of Response For Participants With A Response|Response rates were classified according to the International Uniform Response Criteria for Multiple Myeloma (Durie et al, 2006). Kaplan-Meier methods were used to estimate the median duration of response and associated 95% confidence intervals.|Day 1 up to Month 6|Duration of response was not calculated because the study was terminated early.|||||
765147|NCT00675428|Secondary|Number Of Participants Who Achieve A Complete Response|Response rates were classified according to the International Uniform Response Criteria for Multiple Myeloma (Durie et al, 2006). Complete Response (CR): negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas , and ≤ 5% plasma cells in the bone marrow. Stringent CR (sCR): CR as defined above, and normal free light chain (FLC) ratio, and absence of clonal cells in the bone marrow by immunohistochemistry or immunofluorescence, based on a κ/λ ratio of > 4:1 or < 1:2 performed on a minimum of 100 plasma cells.|Day 1 up to Month 6|||participants|||Number
765148|NCT00675428|Primary|Number of Participants With Adverse Events (AEs)|An AE was defined as any untoward medical occurrence in a participant administered medicinal (investigational) product and that does not necessarily have a causal relationship with this product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. See the adverse events section of the record for more details.|Day 1 up to Month 6|||participants|||Number
769124|NCT00709124|Secondary|Functional Status as Measured by Modified Functional Independence Measurement (FIM) Score Between Those Receiving NMES vs. Sham Sessions||ICU and hospital discharge||||||
765150|NCT00675428|Primary|Number of Participants With Dose Limiting Toxicities (DLTs)|DLTs = any ≥grade 3 toxicity related to treatment; treatment delays of ≥7 days due to any toxicity related to treatment, with the exception of hepatic transaminases; or alanine and/or aspartate aminotransferase (ALT and/or AST) >3*upper limit of normal (ULN) with either a total bilirubin >2*ULN or an international normalized ratio (INR) >1.5 related to treatment, or with the appearance of worsening fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, or eosinophilia.|Day 1 up to Day 28|||participants|||Number
765151|NCT00675441|Primary|Number of Participants' With Treatment Response of Complete or Partial Response|Treatment responses defined as complete (CR) or partial organ response (PR) of chronic Graft-Versus-Host Disease (GVHD) to lenalidomide. Complete organ response (CR) indicates resolution of all reversible manifestations related to chronic GVHD in a specific organ. Partial organ response (PR) requires at least 50% improvement in scale used to measure disease manifestations related to chronic GVHD. Tools for response evaluation were skin assessment and functional assessment including minute walk and grip strength.|Response assessed after completing 28 day cycle, repeated with each cycle for 6 cycles, approximately 180 days.|Of the five (5) participants enrolled, two participants were taken off study after only a few days of therapy and one participant expired, all three of which were not evaluable for response.||participants|||Number
765152|NCT00675506|Secondary|Mitochondrial Function by 31P-MRS|Analysis ongoing, no data available currently.|Measured at Baseline and Months 6 and 12||||||
765153|NCT00675506|Secondary|Change in Growth Hormone Pulse Characteristics as Assessed by Overnight Frequent Sampling of Growth Hormone|Analysis ongoing, no data available currently.|Measured at baseline and Month 12||||||
765154|NCT00675506|Secondary|Change in Glucose Tolerance as Measured by Oral Glucose Tolerance Test|Glucose tolerance was determined after an overnight fast using standard 75 gram oral glucose tolerance test (OGTT) with glucose measured at timepoints 0, 30, 60, 90 and 120. Change in glucose tolerance (fasting and 2 hour OGTT) between baseline and twelve months is reported.|Measured at baseline and Months 6 and 12|All data were included in the analysis by intention to treat principle. For participants who did not complete a 12-month visit, last observation carried forward was performed for those participants for whom interim data post the baseline visit was available. Data from 6 month is utilized in the linear mixed effects modeling.||mg/dL||Standard Error|Mean
765155|NCT00675506|Secondary|Change in Lipid Profile (Total Cholesterol, High-density Lipoproteins [HDL] Cholesterol, Low-density Lipoproteins [LDL] Cholesterol, Triglycerides)|Lipid Profile (total cholesterol, high-density lipoproteins [HDL] cholesterol, low-density lipoproteins [LDL] cholesterol, triglycerides)was determined after an overnight fast. The change in lipid profile between baseline and 12 months is reported.|Measured at baseline and Months 6 and 12|All data were included in the analysis by intention to treat principle. For participants who did not complete a 12-month visit, last observation carried forward was performed for those participants for whom interim data post the baseline visit was available. Data from 6 month is utilized in the linear mixed effects modeling.||mg/dL||Standard Error|Mean
765156|NCT00675506|Secondary|Change in Carotid Intima-media Thickness|Carotid intima media thickness imaging of the common carotid artery was conducted using a high-resolution 7.5-MHz phased-array transducer (SONOS 2000/2500. The change of the carotid intima media thickness measurement between baseline and 12 months is reported.|Measured at baseline and Months 6 and 12|All data were included in the analysis by intention to treat principle. For participants who did not complete a 12-month visit, last observation carried forward was performed for those participants for whom interim data post the baseline visit was available. Data from 6 month is utilized in the linear mixed effects modeling.||mm||Standard Error|Mean
765157|NCT00675506|Primary|Change in Visceral Adipose Tissue Volume|Abdominal visceral adipose tissue and subcutaneous adipose tissue were assessed using a single crosssectional slice from noncontrast computed tomography at the L4 level. The change in abdominal visceral adiposity between baseline and twelve months is reported.|Measured at baseline and Months 6 and 12|All data were included in the analysis by intention to treat principle. For participants who did not complete a 12-month visit, last observation carried forward was performed for those participants for whom interim data post the baseline visit was available. Data from 6 month is utilized in the linear mixed effects modeling.||cm2||Standard Error|Mean
765158|NCT00675558|Secondary|Maximum Reaction Velocity (Vmax) for Fatty Acid Uptake Relative to Adipocyte Cell Surface Area|Fatty acid uptake was expressed relative to adipocyte cell surface area [Vmax’(pmol/sec/µm^2) = Vmax/(cell surface area) X 10^8].|4 years|||pmol/sec/μm^2||Standard Deviation|Mean
765159|NCT00675558|Primary|Maximum Reaction Velocity (Vmax) for Facilitated LCFA Uptake|The Vmax for facilitated Long Chain Fatty Acids (LCFA) uptake by omental adipocytes was measured.|4 years|||pmol/sec||Standard Deviation|Mean
765160|NCT00675558|Primary|Size of Adipocytes|The mean diameters of omental adipocytes were measured|4 years|||µm||Standard Deviation|Mean
765161|NCT00675584|Secondary|Caregiver Quality of Life||Measured at Month 12||||||
765162|NCT00675584|Secondary|Symptom Severity During Respiratory Tract Illness||Measured at 7 days for each respiratory tract illness||||||
765163|NCT00675584|Secondary|Rate of Rescue Albuterol Use||Measured at Month 12||||||
765164|NCT00675584|Secondary|Absences From Daycare and Preschool for the Child and From Work for the Caregiver||Measured at Month 12||||||
765165|NCT00675584|Secondary|Adverse Events Associated With Corticosteroid Use||Measured at Month 12||||||
765166|NCT00675584|Secondary|Changes in Pulmonary Reactance and Resistance||Measured at Month 12||||||
765167|NCT00675584|Secondary|Changes in Exhaled Nitric Oxide Levels||Measured at Month 12||||||
765168|NCT00675584|Secondary|Time to Treatment Failure||Measured at Month 12||||||
765169|NCT00675584|Secondary|Rate of Urgent Care Visits, Emergency Department Visits, or Hospitalizations for Wheezing or Asthma||Measured at Month 12||||||
765170|NCT00675584|Secondary|Proportion of Episode-free Days||Measured at Month 12||||||
765171|NCT00675584|Primary|Rate of Exacerbations Requiring Systemic Corticosteroids|The rate of exacerbations was calculated as the number of exacerbations requiring prednisone per years of follow-up|Measured at Month 12|Even if a child terminated prior to completion of the 12 months of follow-up, he/she contributed to the numrerator and denominator of the exacerbation rate||events per years of follow-up||Standard Error|Mean
769125|NCT00709124|Secondary|Respiratory Muscle Strength: Maximum Inspiratory Pressure (MIP) Between Those Who Receive NMES vs. Sham Sessions||ICU and hospital discharge||||||
765172|NCT00675597|Primary|To Measure the Number of Cycles|Cycle delivery is a surrogate for drug delivery. Both cycle delivery and drug delivery will be measured in this study. However, cycle delivery (up to 4 cycles) is the common way drug delivery is measured in the literature, and therefore cycle delivery has been chosen as the primary endpoint for this study.Two doses of both docetaxel plus vinorelbine, delivered over 4 weeks, constitutes one cycle. If either drug is discontinued, the subject will remain on study, however that patient will not get credit for completing subsequent cycles of therapy. If the dose of either drug is reduced, the subject will remain on study and get credit for subsequent cycles.|2 years|||participants|||Number
765173|NCT00675766|Primary|Neuropsychological Status (i.e., Cognitive Functioning)|Neurocognitive functions refer to cognitive abilities, namely learning/memory, motor speed, psychomotor speed, language, attention, visuospatial abilities, & executive function. They are measured using standard clinical neuropsychological test battery that included: HVLT, BVMT-R, Trails A & B, WCST-64, WAIS-Symbol Search/Digit Coding/Letter-Number Sequencing/Block Design, FAS, & Animals. Subgroups of these tasks were combined to create composite scores indicating participants' score on each cognitive domains. To make these cognitive domain composite scores, each participant's raw score on each of these tests was converted into a within-sample standardized score (i.e., z-score), which are normally distributed with a mean of 0 & SD of 1. Then, these standardized scores were summed to create composite scores for each cognitive domain and then averaged to create a global neuropsychological function composite score. A positive composite score represents a better outcome for all variables.|Baseline (Year 1) and 1-year follow-up (Year 2)|HIV+ and HIV negative men who were evaluated BOTH at baseline and Year 2. Those participants who were evaluated at Baseline but not at Year 2 were excluded from analyses.||z-score composites of cognitive domains||Standard Error|Mean
765174|NCT00675792|Secondary|Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.7|Neuromuscular function was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds, and assessing T1 and T4 twitch response at the adductor pollicis muscle with a TOF-Watch® SX. Nerve stimulation was continued until the T4/T1 ratio, which indicates the extent of recovery from neuromuscular blockade, achieved a ratio of 0.7, with imputed data included.|Up to 1 hour after treatment|ITT group consisting of all randomized participants who were treated with sugammadex or neostigmine and had at least one efficacy measurement. Three participants treated with neostigmine did not have at least one efficacy measurement, and hence were excluded from the analysis.||Minutes||Standard Deviation|Mean
765175|NCT00675792|Secondary|Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.8|Neuromuscular function was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds, and assessing T1 and T4 twitch response at the adductor pollicis muscle with a TOF-Watch® SX. Nerve stimulation was continued until the T4/T1 ratio, which indicates the extent of recovery from neuromuscular blockade, achieved a ratio of 0.8, with imputed data included.|Up to 1 hour after treatment|ITT group consisting of all randomized participants who were treated with sugammadex or neostigmine and had at least one efficacy measurement. Three participants treated with neostigmine did not have at least one efficacy measurement, and hence were excluded from the analysis.||Minutes||Standard Deviation|Mean
765176|NCT00675792|Secondary|Time From Start of Administration of Investigational Medicinal Product (IMP) to Recovery of the T4/T1 Ratio to 0.9|Neuromuscular function was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds, and assessing T1 and T4 twitch response at the adductor pollicis muscle with a TOF-Watch® SX. Nerve stimulation was continued until the T4/T1 ratio, which indicates the extent of recovery from neuromuscular blockade, achieved a ratio of 0.9, with imputed data included.|Up to 1 hour after treatment|ITT group consisting of all randomized participants who were treated with sugammadex or neostigmine and had at least one efficacy measurement. Three participants treated with neostigmine did not have at least one efficacy measurement, and hence were excluded from the analysis.||Minutes||Standard Deviation|Mean
765177|NCT00675792|Secondary|Number of Participants With Evidence of Possible Interaction of Sugammadex With Endogenous Compounds or Exogenous Compounds Other Than Rocuronium Bromide|Evidence of adverse events due to a possible interaction of sugammadex with exogenous compounds or endogenous compounds other than rocuronium was recorded.|Up to 7 days after surgery|All subjects treated (AST) group consisting of randomized participants who were treated with sugammadex or neostigmine||participants|||Number
765178|NCT00675792|Secondary|Number of Participants With Post-operative Complications|Post-operative complications include any of the following: procedural pain, nausea, vomiting, incision-site pain, constipation, headache, pyrexia, dizziness and pruritus.|Up to 7 days after surgery|All subjects treated (AST) group consisting of randomized participants who were treated with sugammadex or neostigmine||participants|||Number
765179|NCT00675792|Primary|Residual Neuromuscular Blockade Evidenced by T4/T1 Ratio at the Time of Tracheal Extubation|Neuromuscular function was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds, and assessing twitch response at the adductor pollicis muscle with a TOF-Watch® SX. The magnitudes (heights) of the first and fourth twitches (T1 and T4) were used to calculate the T4/T1 ratio, where a higher T4/T1 ratio indicates a greater recovery from neuromuscular blockade, with a value of 1.0 indicating complete recovery. After anesthesia, when neuromuscular function was expected to be fully recovered, tracheal extubation was performed, at which time the T4/T1 ratio was measured, with any missing recovery times imputed.|Up to the first 24 hours after tracheal extubation|Intent to treat (ITT) group consisting of all randomized participants who were treated with sugammadex or neostigmine and had at least one efficacy measurement. Three participants treated with neostigmine did not have at least one efficacy measurement, and hence were excluded from the analysis.||T4/T1 Ratio||Standard Deviation|Mean
765180|NCT00675909|Secondary|Respiratory Rate||Every 5 minutes during ED visit||||||
765181|NCT00675909|Secondary|Heart Rate||Every 5 minutes during ED visit||||||
765182|NCT00675909|Secondary|Oxygen Saturation||During entire ED visit||||||
765183|NCT00675909|Secondary|Anxiety||Every 5 minutes during ED visit||||||
765184|NCT00675909|Primary|Safety||During entire ED visit||||||
765185|NCT00675909|Primary|Caregiver and Parental Satisfaction||At end of procedure for caregiver and follow up phone call for parent||||||
765186|NCT00675909|Primary|Length of Stay||Minutes of ED stay||||||
769126|NCT00709124|Secondary|Overall Body Strength: Hand Grip Between Those Who Receive NMES vs. Sham Sessions||ICU and hospital discharge||||||
765187|NCT00675909|Primary|Change in CHEOPS Score Measured Level of Sedation From Baseline (Presentation in ED, Before Sedation) to Start of Procedure (Laceration Repair).|"Modified CHEOPS (Children's Hospital of Eastern Ontario Pain Scale)assessment used to score sedation.
Scale range is 0-10 with 0 meaning no pain and 4 or greater meaning pain. Scale is determined by assessing Facial Expression (0-2), Cry (0-3), Child Verbal (0-2) and Movements (0-3)."|Baseline (presentation, before sedation) in ED to start of procedure (laceration repair).|Intention to treat||Scores on a scale||95% Confidence Interval|Median
765188|NCT00675922|Secondary|Length of Hospital Stay With Various Antimicrobial Solutions for Burn Patients||Admission to burn unit to discharge||||||
765189|NCT00675922|Primary|Infection Rate|Percent of infections following antimicrobial topical treatment with Sulfamylon vs Silver Nitrate Soaks.|Acute hospitalization following burn injury: admission to discharge (1-20 weeks)|Percent of sites treated with sulfamylon of Silver Nitrate soaks that developed infections||percentage of participants|||Number
765190|NCT00675948|Secondary|Change From Baseline in the Mean EORTC Quality of Life-C30 Questionnaire - Global Health Status Score at the End of Treatment|The EORTC Quality of Life-C30 Health Status visual analogue scale was a self-reported score where subjects rated their health state from: 0 = worst health state imaginable to 100 = best health state imaginable. An increase in score from baseline indicates an improvement in condition. The end of treatment was classed as study completion or withdrawal, if this occurred sooner. Calculation of mean EORTC Quality of Life-C30 Health Status scores was only produced when data was available for 10 or more subjects at the relevant study visits. As such, no mean scores were calculated for subjects taking THC alone.|0 - 657 days|The efficacy analyses were conducted on data from all randomised subjects who received at least one dose of study medication and who yielded on-treatment efficacy data.||units on a scale||Standard Deviation|Mean
765191|NCT00675948|Secondary|Change From Baseline in the Mean Brief Pain Inventory (Short Form) - Pain Severity Score at the End of Treatment|The Brief Pain Inventory (Short Form) is a 14-item questionnaire that asks subjects to rate pain over the prior week and the degree to which it interferes with activities on a 0 to 10 scale, where 0=no pain and 10=pain as bad as you can imagine. Severity is measured as worst pain, least pain, average pain, and pain right now. The severity composite score was calculated as the arithmetic mean of the four severity items (range 0-10). The minimum value is zero and maximum is 10. A negative value indicates an improvement in score from baseline. The end of treatment was classed as study completion or withdrawal, if this occurred sooner. Calculation of the mean Brief Pain Inventory (Short Form) score was only carried out when data was available for 10 or more subjects at the relevant study visits. As such, no mean scores were calculated for subjects taking THC alone.|0 - 657 days|The efficacy analyses were conducted on data from all subjects who entered the study, who were randomised, who received at least one dose of study medication and who yielded on-treatment efficacy data||units on a scale||Standard Deviation|Mean
765192|NCT00675948|Primary|The Incidence of Adverse Events as a Measure of Subject Safety|The number of subjects who experienced an adverse event in this study is presented.|0 - 657 days|All subjects who took at least one dose of study medication and yielded on-treatment efficacy data were classed as the safety population.||participants|||Number
765193|NCT00675987|Primary|Insulin Sensitivity Utilizing Endothelial Function as Assessed by Pulse Volume Amplitude|Endothelial function assessed as the ratio of pulse volume amplitude after compared with before a reactive hyperemia stimulus, measured by peripheral (fingertip) arterial tonometry. Reported values indicate the percentage change from Baseline in the ratio of pulse volume amplitude after compared to before the reactive hyperemia stimulus.|baseline, 8 weeks|analysis was ITT, but limited to those with interpretable data (3 clamp studies were exlcuded)||percentage change||Standard Deviation|Mean
765194|NCT00675987|Secondary|To Assess the Change From Baseline Cytokines, Markers of Inflammation, and Markers of Oxidative Stress After 8 Weeks of Treatment. Also to Assess the Effect on Microalbuminuria After 8 Weeks of Treatment.||baseline, 8 weeks||||||
765195|NCT00675987|Primary|Insulin Sensitivity Utilizing the Euglycemic Hyperinsulinemic Clamp|Insulin clamp derived insulin sensitivity, as insulin stimulated glucose disposal corrected for steady state insulin level.|baseline, 8 weeks|analysis was ITT, but limited to those with interpretable data (3 clamp studies were exlcuded)||mg/kg/min||Standard Deviation|Mean
765196|NCT00676026|Primary|To Determine the Impact of GABA-A Receptor Agonists (Benzodiazepines, Allopregnanolone) and Other GABA-modulating Agents (Fluoxetine) on Cortical GABA Levels by Menstrual Cycle Phase as Measured Using 1H-MRS in Healthy Controls.|This study was conducted at Yale University almost two decades ago. Our group at the University of Pennsylvania only has very basic information about this study. This includes the number of participants, which was 8, and the fact that no adverse events occurred. Staff members at the University of Pennsylvania do not have access to any additional study data. The contact person who initially entered this study protocol information is no longer at the University of Pennsylvania and we are unable to contact for additional information.|Each medication will be administered 2 times during a 1-month menstrual cycle.|UPenn does not have access to the data collected for this study. We are only using the information entered in the protocol section for very basic details in the results section (i.e, number of participants completed). The original contact person for this protocol is not reachable.|||||
765209|NCT00676091|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age)|Pre-specified local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 4 days after dose 3 (6 months of age)|Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting yes for at least 1 day or no for all days.||percentage of participants|||Number
765201|NCT00676065|Primary|Breast Cancer|Breast cancer associated with the use of hormonal contraceptives either containing both drospirenone (DRSP) and ethinylestradiol (EE), levonorgestrel (LNG) or any other hormonal contraceptive without DRSP.|Within 10 years|The number of participants refers to the ITT study population. During the course od the study, women could for example stop use of oral contraception at any point of time. Therefore, the woman-years of exposure for each group are provided in addition.||participants|Participants||Number
765202|NCT00676065|Primary|Venous Thromboembolism|Venous thromboembolism associated with the use of oral contraceptives containing drospirenone or levonorgestrel or other progestogens.|Within 10 years|The number of participants refers to the ITT study population. During the course od the study, women could for example stop use of oral contraception at any point of time. Therefore, the woman-years of exposure for each group are provided in addition.||participants|Participants||Number
765203|NCT00676065|Primary|Arterial Thromboembolism|Arterial thromboembolism associated with the use of oral contraceptives containing drospirenone or levonorgestrel or other progestogens.|Within 10 years|The number of participants refers to the ITT study population. During the course od the study, women could for example stop use of oral contraception at any point of time. Therefore, the woman-years of exposure for each group are provided in addition.||participants|Participants||Number
765204|NCT00676091|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events: Toddler Dose (12 Months of Age)|Pre-specified systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after toddler dose (12 months of age)|Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting yes for at least 1 day or no for all days.||percentage of participants|||Number
765205|NCT00676091|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age)|Pre-specified systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after dose 3 (6 months of age)|Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting yes for at least 1 day or no for all days.||percentage of participants|||Number
765206|NCT00676091|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age)|Pre-specified systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after dose 2 (4 months of age)|Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting yes for at least 1 day or no for all days.||percentage of participants|||Number
765207|NCT00676091|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age)|Pre-specified systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after dose 1 (2 months of age)|Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting yes for at least 1 day or no for all days.||percentage of participants|||Number
765208|NCT00676091|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age)|Pre-specified local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 4 days after toddler dose (12 months of age)|Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting yes for at least 1 day or no for all days.||percentage of participants|||Number
765210|NCT00676091|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age)|Pre-specified local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 4 days after dose 2 (4 months of age)|Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting yes for at least 1 day or no for all days.||percentage of participants|||Number
765211|NCT00676091|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age)|Pre-specified local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 4 days after dose 1 (2 months of age)|Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting yes for at least 1 day or no for all days.||percentage of participants|||Number
765212|NCT00676091|Secondary|Percentage of Participants Achieving Antibody Level ≥5 EU/mL for Pertussis in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose|Percentage of participants achieving predefined antibody threshold ≥5 EU/mL along with the corresponding 95% CI for concomitant antigen pertussis (pertussis toxoid [PT], filamentous hemagglutinin [FHA], and pertactin [PRN]) are presented.|1 month after the toddler dose (13 months of age)|Evaluable immunogenicity population. N=number of participants with a determinate antibody concentration to the given concomitant vaccine component.||percentage of participants||95% Confidence Interval|Number
765213|NCT00676091|Secondary|Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Mcg/mL in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose|Percentage of participants achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|1 month after the toddler dose (13 months of age)|Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype.||percentage of participants||95% Confidence Interval|Number
765214|NCT00676091|Primary|Percentage of Participants Achieving Antibody Level ≥5 Enzyme-linked Immunosorbent Assay (ELISA) Units Per mL (EU/mL) for Pertussis in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series|Percentage of participants achieving predefined antibody threshold ≥5 enzyme-linked immunosorbent assay (ELISA) units per mL (EU/mL) along with the corresponding 95% CI for concomitant antigen pertussis (pertussis toxoid [PT], filamentous hemagglutinin [FHA], and pertactin [PRN]) are presented.|1 month after the infant series (7 months of age)|Evaluable immunogenicity population. N=number of participants with a determinate antibody concentration to the given concomitant vaccine component.||percentage of participants||95% Confidence Interval|Number
765215|NCT00676091|Primary|Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Micrograms Per Milliliter (Mcg/mL) in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series|Percentage of participants achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|1 Month after the infant series (7 Months of age)|Evaluable immunogenicity population: treatments as randomized at all expected doses, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations. N=number of participants with a determinate IgG antibody concentration to the given serotype.||percentage of participants||95% Confidence Interval|Number
765216|NCT00676130|Secondary|Progression to Abscess|Proportion of subjects in each arm with progression from cellulitis to abscess.|12 +/- 2 days, 30 days +/- 2 days|||participants|||Number
765217|NCT00676130|Primary|Relative Efficacy|"Proportion of subjects in each arm with successful treatment.
Treatment success was assessed by physician examination at 12 +/- 2 days. Non-success was defined as subsequent hospitalization, change in antibiotics, surgical or needle drainage of an abscess, or recurrence of infection within 30 days. Cure was defined as resolution of all symptoms other than mild residual erythema or edema. We confirmed the determination of cure by telephone interview and medical record review at 30 +/- 2 days."|12 +/- 2 days; 30 +/- 2 days|Of the 153 randomized subjects, 4 were randomized in error and did not receive study drug, 1 received two doses before it was discovered that he was ineligible, 1 was lost to follow up, and 1 withdrew voluntarily in the first few days after enrollment. This left 146 subjects for intent-to-treat analysis.||participants|||Number
765218|NCT00676143|Secondary|Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SOB) Total Score at Week 78|The CDR-SOB is a global clinical staging instrument that sums 6 clinical ratings: 1) memory, 2) orientation, 3) judgment and problem solving, 4) involvement in community affairs, 5) home and hobbies, and 6) personal care based on the Clinical Dementia Rating Scale (CDR) interview. The CDR includes discussions with the participant and caregiver using a structured format. This scale had to be administered by a trained and certified global rater who did not have access to any information regarding adverse events experienced by the participant. CDR-SOB total score range is 0 (least impairment) to 18 (most impairment); a negative change from baseline indicates an improvement.|Baseline and 78 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.||Units on a scale||Standard Error|Least Squares Mean
765219|NCT00676143|Secondary|Percentage of Responders for DAD Total Score at Week 78 (US Analysis Plan)|Percentage of participants whose decrease (worsening) from baseline to Week 78 in DAD total score was <12.|Baseline and 78 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.||Percentage of participant|||Number
765220|NCT00676143|Secondary|Percentage of Participants With Worsening From Baseline in DAD Total Score at Week 78 (EU Analysis Plan)|Percentage of participants whose decrease (worsening) from baseline to Week 78 in DAD total score of ≤ 0, ≤ 6, and ≤ 12 points. In order to calculate time to first median placebo deterioration in DAD, the median change from baseline to Week 78 among the placebo participants of the mITT analysis population were determined. The median changes were used as the cutpoints for determining “deterioration” for Alzheimer’s disease participants in the study. If the median change from baseline to Week 78 in the DAD total score among the placebo participants of the mITT Analysis Population is 7 points, then the first median placebo deterioration is the first time where there is a worsening on the DAD total score of 7 points or more and the worsening is confirmed by the DAD assessment at the next non-missing visit.|Baseline and 78 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.||Percentage of participants||95% Confidence Interval|Number
765221|NCT00676143|Secondary|Percentage of Responders for ADAS-Cog/11 Total Score at Week 78 (US Analysis Plan)|Percentage of participants whose increase (worsening) from baseline to Week 78 in ADAS-Cog/11 total score was <7.|Baseline and 78 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.||Percentage of participant|||Number
765222|NCT00676143|Secondary|Percentage of Participants With Worsening From Baseline in ADAS-Cog/11 Total Score at Week 78 (EU Analysis Plan)|Percentage of participants with worsening from baseline to Week 78 in ADAS-Cog/11 total score of ≤0, ≤3, and ≤7 points were reported. In order to calculate time to first median placebo deterioration in ADAS-Cog/11, the median change from baseline to Week 78 among the placebo participants of the mITT analysis population were determined. The median changes were used as the cutpoints for determining “deterioration” for Alzheimer’s disease participants in the study. If the median change from baseline to Week 78 in the ADAS-Cog/11 total score among the placebo participants of the mITT Analysis Population is 7 points, then the first median placebo deterioration is the first time where there is a worsening on the ADAS-Cog/11 total score of 7 points or more and the worsening is confirmed by the ADAS-Cog/11 assessment at the next non-missing visit.|Baseline and 78 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.||Percentage of participants||95% Confidence Interval|Number
765223|NCT00676143|Secondary|Change From Baseline in Dependence Scale Total Score at Week 78|The Dependence Scale (DS) is a 13-item, caregiver-rated instrument for determining the amount of support required by a participant with AD. The DS total score ranges from 0 to 15, with higher scores indicating more need for assistance. The DS was administered as an interview to the caregiver at scheduled study visits.|Baseline and 78 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.||Unit on a scale||Standard Error|Least Squares Mean
765224|NCT00676143|Secondary|Time to First Clinically Meaningful Deterioration on DAD Total Score (US Analysis)|The time to first clinically meaningful deterioration was defined as the first time a participant experienced a decrease (worsening) from baseline in DAD total score of >=12.|Baseline and 78 Weeks|||Days||95% Confidence Interval|Median
765225|NCT00676143|Secondary|Time to First Median Placebo Deterioration on DAD Total Score (EU Analysis Plan)|The time to first median placebo deterioration was defined as the first time a participant experienced a decrease (worsening) in DAD total score greater than or equal to the median worsening at Week 78 in the placebo group.|Baseline and 78 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.||Days||95% Confidence Interval|Median
765226|NCT00676143|Secondary|Time to First Clinically Meaningful Deterioration on ADAS-Cog/11 Total Score (United States [US] Analysis Plan)|The time to first clinically meaningful deterioration was defined as the first time a participant experienced an increase (worsening) from baseline in ADAS-Cog/11 total score of >=7.|Baseline and 78 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.||Days||95% Confidence Interval|Median
765227|NCT00676143|Secondary|Time to First Median Placebo Deterioration on ADAS-Cog/11 Total Score (European Union [EU] Analysis Plan)|The time to first median placebo deterioration, defined as the first time a participant experienced an increase (worsening) from baseline in ADAS-Cog/11 total score greater than or equal to the median worsening observed at Week 78 in the placebo group. The Kaplan Meier estimate of median time to first median placebo deterioration was presented.|Baseline and 78 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.||Days||95% Confidence Interval|Median
765228|NCT00676143|Secondary|Divergence of Effect on the DAD Total Scores From Week 39 to Week 78|Treatment differences are estimated using least-squares (LS) means with factor levels weighted according to overall analysis population proportions. DAD total score range is 0 to 100; a positive treatment difference (bapineuzumab minus placebo) favors bapineuzumab. Within the MMRMs for ADAS-Cog/11 described for the primary analyses, linear contrasts were formed to test increasing trend of the differences between bapineuzumab and placebo from Week 39 (the 9-month visit) through Week 78 (the 18 –month visit) for each variable, which is equivalent to testing a positive slope of the differences between each bapineuzumab dose group and placebo from Week 39 through Week 78. Results are from a restricted maximum likelihood (REML)-based mixed model for MMRM.|Week 39 to Week 78|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.||Units/Year||Standard Error|Least Squares Mean
765369|NCT00676806|Secondary|Compare Rates of Complications Between Patients Receiving Ablative vs. Non-myeloablative Conditioning Prior to UCB Transplantation|Composite endpoint of GVH or infection. Too few events to compare between arms.|+180 days|||events|||Number
765229|NCT00676143|Secondary|Divergence of Effect on the ADAS-Cog/11 Total Scores From Week 39 to Week 78|Treatment differences are estimated using least-squares (LS) means with factor levels weighted according to overall analysis population proportions. ADAS-Cog/11 total score range is 0 (least impairment) to 70 (most impairment); a negative treatment difference (bapineuzumab minus placebo) favors bapineuzumab. Within the MMRMs for ADAS-Cog/11 described for the primary analyses, linear contrasts were formed to test increasing trend of the differences between bapineuzumab and placebo from Week 39 (the 9-month visit) through Week 78 (the 18 –month visit) for each variable, which is equivalent to testing a positive slope of the differences between each bapineuzumab dose group and placebo from Week 39 through Week 78. Results are from a restricted maximum likelihood (REML)-based mixed model for MMRM.|Week 39 to Week 78|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.||Units/Year||Standard Error|Least Squares Mean
765230|NCT00676143|Secondary|Change From Baseline in Brain Volume, as Assessed by Magnetic Resonance Imaging Brain Boundary Shift Integral (MRI BBSI), at Week 71|Cerebral atrophy correlates closely with the gradual cognitive decline in AD and can be visualized by MRI. The BBSI technique involves positional matching of serial 3-dimensional MRI brain images, such that brain MRI-image volumes were first registered and then subtracted from each other. Atrophy rates would generally be expected to be lower if the underlying disease was attenuated by effective treatment.|Baseline and 71 Weeks|vMRI population included all randomized participants who enrolled in the vMRI substudies, received at least one infusion or portion of an infusion of study drug, and had a baseline and at least one postbaseline vMRI that passed quality control and was satisfactory for volumetric analysis.||Milliliter (mL)/year||Standard Error|Least Squares Mean
765231|NCT00676143|Secondary|Change From Baseline in Cerebrospinal Fluid (CSF) Phospho-tau Levels at Week 71|Biomarkers CSF phospho-tau is an indicator of neuronal injury and neurodegeneration. An elevation in levels of tau, as well as specific p-tau species, is thought to be a marker for progressive cellular degeneration in AD. Accordingly, a reduction from baseline in levels of CSF tau in participants who received bapineuzumab compared with participants who received placebo may be indicative of a reduction in neuronal loss in participants treated with bapineuzumab.|Baseline and 71 Weeks|CSF population included all randomized participants who enrolled in the CSF substudies, received at least one infusion or portion of an infusion of study drug, and had a baseline and at least one postbaseline CSF measurement (CSF phospho-tau).||pg/mL||Standard Error|Least Squares Mean
765232|NCT00676143|Secondary|Change From Baseline in Brain Amyloid Burden at Week 71|Brain amyloid burden as imaged by 11C-Pittsburgh compound B (PIB) positron emission tomography (PET). The latter is a semi-quantitative measure of the extent of fibrillar amyloid in the brain. PIB PET measurements were made in cortical regions found to have the highest burden of fibrillar amyloid at autopsy in participants diagnosed as having Alzheimer’s pathology, and also regions reported to have the highest average retention of PIB signal in previous PET studies enrolling participants with probable AD. This parameter reflects overall brain amyloid deposition as indexed by imaging. The change from baseline was measured as average standard uptake value ratio (SUVr) in prespecified regions of interest (ROI) assessed by PIB PET imaging in a subset of participants.|Baseline and 71 weeks|PIB PET population included all randomized participants who enrolled in the PET substudies and who met the following criteria: a) received at least one infusion or portion of an infusion of study drug, b) had a baseline and at least one postbaseline PIB PET assessment, and c) had an SUVr for the global cortical average (GCA) ROI ≥1.35 at baseline.||standard uptake value ratio||Standard Error|Least Squares Mean
765233|NCT00676143|Primary|Change From Baseline in Disability Assessment for Dementia (DAD) Total Score at Week 78|"The DAD measures instrumental and basic activities of daily living in participants with Alzheimer's Disease (AD). The DAD is administered to the participants’caregiver in the form of an interview. This scale had to be administered by a trained and certified psychometric rater who did not have access to any information regarding adverse events experienced by the participant.
This scale assesses a participants’ ability to initiate, plan, and perform activities related to hygiene, dressing, continence, eating, meal preparation, telephoning, going on an outing, finance and correspondence, medications, leisure, and housework. Each item can be scored as 1 = yes, 0 = no, non applicable = NA. A total score is obtained by adding the rating for each question and converting this total score out of 100. Higher scores indicate better function; a positive change from baseline indicates an improvement."|Baseline and 78 weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.||Unit on a scale||Standard Deviation|Least Squares Mean
765234|NCT00676143|Primary|Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog)/11 Subscale Total Score at Week 78|"The ADAS-Cog is a multi-item, objective measure of cognitive function. The scale evaluates memory, language, and praxis with items such as orientation, word recall, word recognition, object identification, comprehension, and the completion of simple tasks. Analysis of the ADAS-Cog for this study was based upon an 11 item score from the following items 1) word recall task, 2) naming objects and fingers, 3) following commands, 4) constructional praxis, 5) ideational praxis, 6) orientation, 7) word recognition, 8) remembering test instructions, 9) spoken language ability, 10) word finding difficulty in spontaneous speech, and 11) comprehension.
This scale had to be administered by a trained and certified psychometric rater who did not have access to any information regarding adverse events experienced.
The ADAS-Cog/11 ranged from 0 to 70 points, with higher scores indicating a greater degree of impairment. A negative change from baseline indicates a decrease in cognitive impairment."|Baseline and 78 weeks|The modified intent-to-treat (mITT) included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and Disability Assessment for Dementia (DAD) total score.||Unit on a scale||Standard Error|Least Squares Mean
765235|NCT00664066|Primary|Assess the Incidence and Severity of All Predefined Cardiovascular Events in Subjects Treated With Dynepo|This study was terminated on July 31, 2008 as a result of a decision by Shire Pharmaceutical to permanently cease marketing Dynepo and withdraw the Marketing Authorisation. The decision was for commercial reasons, it was not the result of any safety signal.|up to 3 years|This study was terminated on July 31, 2008 as a result of a decision by Shire Pharmaceutical to permanently cease marketing Dynepo and withdraw the Marketing Authorisation. The decision was for commercial reasons, it was not the result of any safety signal.||Participants|||Number
765236|NCT00664105|Secondary|Number of Participants With Adverse Events by Grade|Number of participants with adverse events, according to grade of event, using the NCI Common Toxicity Criteria (version 2.0) grading system to assign a grade to each event with 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, and 5 = death related to adverse event|30 days after last treatment.|Patients who received treatment and who experienced an adverse event.||participants|||Number
765237|NCT00664105|Secondary|Time to Disease Progression|Time to disease progression in months|on-study date to date of progression|Patients with disease progression.||Months||Full Range|Median
765238|NCT00664105|Secondary|Overall Response Rate|"Patient response to treatment per RECIST:
Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started Complete response (CR): disappearance of all target lesions Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD"|on-study date to date of best response|Patients who were available for measurement of response. Six patients were not available for measurement of response and are not included in the analyzed population||participants|||Number
765239|NCT00664105|Primary|Overall Survival|Months from on-study to expired/last date known alive.|14.95 months (average duration, on study date to off-study date)|Patients who received at least one treatment and who were available for determination of overall survival.||Months||Full Range|Median
765240|NCT00669617|Primary|Forced Expiratory Volume in 1 Second (FEV1) at 5 Minutes Post-dose|FEV1 was measured at 5 minutes after dosing with spirometry conducted according to internationally accepted standards. The time of dosing was defined as the time corresponding to the use of the first inhaler device. The primary variable was analyzed using a mixed model containing the period baseline FEV1 as covariate. The period baseline FEV1 was the average of the FEV1 value measured in the clinic at 50 and 15 min prior to the study drug administration in that period.|Five Minutes Post Dose|Modified Intent-to-Treat (mITT) population: including all randomized patients who received at least one dose of study drug. If any of the values used in the period baseline FEV1 and FEV1 at 5 min post-dose were collected within 6 hours of rescue medication, then the individual FEV1 value was set to missing.||Liters||Standard Error|Least Squares Mean
765241|NCT00669682|Primary|Number of Positive Twave Studies and Concurrent Positive Optivol Measurement|We wanted to examine whether positive Optivol status corresponded to a higher likelihood of a positive T wave study. The T wave alternans result is determined by a proprietary device that measures T wave and reports the result as negative, positive, or indeterminate. The Optivol measurement is obtained through transthoracic impedance values in the implanted device. We investigated the correlation between Optivol status and T wave alternans status.|upto 3 years|||participants|||Number
765242|NCT00669864|Secondary|Hypoglycaemic Episodes, Diurnal/Nocturnal|Total number of hypoglycaemic episodes experienced in the trial from week 0 (baseline) to week 16 (end of treatment) during the day (diurnal) and the night (nocturnal).|weeks 0-16|Safety analysis set consists of all subjects who entered the trial treatment period and exposed to at least one dose of trial product.||episodes|||Number
765243|NCT00669864|Secondary|Hypoglycaemic Episodes|Total number of hypoglycaemic episodes experienced in the trial from week 0 (baseline) to week 16 (end of treatment). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no plasma glucose or blood glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L or 56 mg/dL.|weeks 0-16|Safety analysis set consists of all subjects who entered the trial treatment period and exposed to at least one dose of trial product.||episodes|||Number
765244|NCT00669864|Secondary|Percentage of Subjects Achieving HbA1c Below or Equal to 6.5%|Percentage of subjects achieving the treatment target of a glycosylated haemoglobin A1c (HbA1c) level below or equal to 6.5% after 16 weeks of treatment|week 16|Intention-to-Treat analysis set (ITT) using LOCF (Last Observation Carried Forward) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product.||percentage of participants|||Number
765245|NCT00669864|Secondary|Percentage of Subjects Achieving HbA1c Less Than 7.0%|Percentage of subjects achieving the treatment target of a glycosylated haemoglobin A1c (HbA1c) level below 7.0% after 16 weeks of treatment|week 16|Intention-to-Treat analysis set (ITT) using LOCF (Last Observation Carried Forward) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product.||percentage of participants|||Number
765246|NCT00669864|Secondary|Change in 8-point Plasma Glucose Profile|Summary of change in 8-point plasma glucose profile by week and time. The 8 time points measured were: Before each meal (breakfast, lunch and dinner), at 2 hours after each meal (breakfast, lunch and dinner), at bedtime, and at 3 AM, measured over 16 weeks of treatment|week 0, week 16|Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product.||mg/dL||Standard Error|Mean
765247|NCT00669864|Primary|Change in HbA1c (Glycosylated Haemoglobin A1c)|Change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 16 weeks (end of treatment)|week 0, week 16|Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product.||percentage (%) of total haemoglobin||Standard Error|Mean
765248|NCT00669903|Secondary|CogState Groton Maze Recall Task (GMRT) Standardized Change Score at Day 14|GMRT score defined as the –log10 transform of the sum of the number of errors made during GMRT trials. Mean GMRT score calculated as the average of the 2 hour, 5 hour, and 8 hour scores. The GMRT standardized change score was calculated as change from baseline in mean GMRT score divided by the within subject standard deviation. Least square means were derived using a mixed effects repeated measures model with protocol scheduled assessment day, treatment group, baseline score, assessment day-by-treatment interaction as fixed factors, center as random factor, and baseline score as a covariate|Baseline and Day 14|||unit on a scale||Standard Error|Least Squares Mean
765284|NCT00670007|Secondary|Percentage of Subjects With Treatment Emergent Adverse Events|Percentage of subjects with treatment-emergent adverse events (TEAEs): overall, by severity, by relatedness, by seriousness, and which occurred within 24 hours of Zemaira administration.|From baseline up to 2.5 years|Safety population comprises all subjects who were included in the study and who received at least 1 dose of Zemaira during study CE1226_3001.||percentage of subjects|||Number
765249|NCT00669903|Secondary|CogState Identification Task (IT) Standardized Change Score at Day 14|IT score defined as 1 times the mean of log10 transformed reaction times for all correct responses. Mean IT score calculated as the average of the 2 hour, 5 hour, and 8 hour scores. The IT standardized change score will be calculated as the change from baseline in the mean IT score divided by the within-subject standard dev. Least square means were derived using a mixed effects repeated measures model with protocol scheduled assessment day, treatment group, baseline score, and assessment day-by-treatment interaction as fixed factors, center as a random factor, and baseline score as a covariate|Baseline and Day 14|||unit on a scale||Standard Error|Least Squares Mean
765250|NCT00669903|Secondary|CogState Detection Task (DT) Standardized Change Score at Day 14|DT score is defined as -1 times the mean of log10 transformed reaction times for all correct responses. Mean DT score was calculated as the average of the 2 hour, 5 hour, and 8 hour scores. The DT standardized change score will be calculated as the change from baseline in the mean DT score divided by the within-subject standard deviation. Score range from negative infinity (worst value) to positive infinity (best value).|Baseline and Day 14|||units on a scale||Standard Error|Least Squares Mean
765251|NCT00669903|Secondary|CogState One Card Learning Task (OCLT) Standardized Change Score at Day 14|OCLT score is defined as the arcsine transform of the proportion of correct responses during OCLT trials. Mean OCLT score was calculated as the average of the 2 hour, 5 hour, and 8 hour scores. The OCLT standardized change score was calculated as the change from baseline in the mean OCLT score divided by the within-subject standard deviation. Scale range from negative infinity (worst value) to positive infinity (best value).|Baseline and Day 14|||units on a scale||Standard Error|Least Squares Mean
765252|NCT00669903|Secondary|CogState Groton Maze Learning Task (GMLT) Standardized Change Score at Day 14|GMLT score is defined as the –log10 transform of the sum of the number of errors made during GMLT trials. Mean GMLT score was calculated as the average of the 2 hour, 5 hour, and 8 hour scores. The GMLT standardized change score was calculated as the change from baseline in the mean GMLT score divided by the within subject standard deviation. Scale range from negative infinity (worst value) to positive infinity (best value).|Baseline and Day 14|||units on a scale||Standard Error|Least Squares Mean
765253|NCT00669903|Primary|CogState Groton Maze Learning Task (GMLT) and One Card Learning Task (OCLT) Standardized Composite Score at Day 14|The GMLT and OCLT standardized change composite score will be calculated as the mean of the GMLT and OCLT standardized change from baseline scores. Least square means were derived using a mixed effects repeated measures model with protocol scheduled assessment day, treatment group, baseline score, and assessment day-by-treatment interaction as fixed factors, center as a random factor, and baseline score as a covariate. Scale range from negative infinity (worst value) to positive infinity (best value).|Baseline and Day 14|||units on a scale||Standard Error|Least Squares Mean
765254|NCT00669916|Secondary|Pharmacokinetics of AIN457: Terminal Elimination Half-life (T1/2)|Blood was drawn for PK analyses at baseline (prior to dosing), end of infusion, 1 hr and 2 hr after infusion, and during office visits in Weeks 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 26. The PK samples may have been taken at any time during each office visit, following the day of study drug infusion. This outcome measure shows the mean of all values resulting from each time point outlined above.|Day 182|All AIN457A treatment group participants||day||Standard Deviation|Mean
765255|NCT00669916|Primary|Percentage of Participants With Change From Baseline in Investigators Global Assessment (IGA) Score|The IGA is an instrument which captured and categorized the global assessment of all clinical signs and symptoms of disease. The investigator used all available information for the assessment, including subjective information from the participant and (where available) photographs taken at baseline. The IGA categories were clear, almost clear, mild disease, moderate disease, severe disease and very severe disease. This outcome measure shows the percentage of patients who experienced a category change from baseline. Category changes of 1, 2 or 3 indicate improvement.|Baseline, Week 4|All participants||Percentage of participants|||Number
765256|NCT00669916|Secondary|Pharmacokinetics of AIN457: Systemic Clearance From Serum Following Intravenous Administration (CL)|Blood was drawn for PK analyses at baseline (prior to dosing), end of infusion, 1 hr and 2 hr after infusion, and during office visits in Weeks 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 26. The PK samples may have been taken at any time during each office visit, following the day of study drug infusion. This outcome measure shows the mean of all values resulting from each time point outlined above.|Day 182|The population included all AIN457A treatment group participants except for two participants who had a nontypical PK profile for Tmax, Cmax, CI and Vz.||Liters/day||Standard Deviation|Mean
765257|NCT00669916|Secondary|Pharmacokinetics of AIN457: Volume of Distribution During the Terminal Phase Following Intravenous Elimination (Vz)|Blood was drawn for PK analyses at baseline (prior to dosing), end of infusion, 1 hr and 2 hr after infusion, and during office visits in Weeks 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 26. The PK samples may have been taken at any time during each office visit, following the day of study drug infusion. This outcome measure shows the mean of all values resulting from each time point outlined above.|Day 182|The population included all AIN457A treatment group participants except for two participants who had a nontypical PK profile for Tmax, Cmax, CI and Vz.||Liters||Standard Error|Mean
765258|NCT00669916|Secondary|Pharmacokinetics of AIN457: Area Under the Serum Concentration-time Cure From Time Zero to the Time of Last Quantifiable Concentration (AUClast), Area Under the Serum Concentration-time Curve From Time Zero to (AUCinf)|Blood was drawn for PK analyses at baseline (prior to dosing), end of infusion, 1 hr and 2 hr after infusion, and during office visits in Weeks 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 26. The PK samples may have been taken at any time during each office visit, following the day of study drug infusion. This outcome measure shows the mean of all values resulting from each time point outlined above.|Day 182|All AIN457A treatment group participants||day*ug/mL||Standard Deviation|Mean
765259|NCT00669916|Secondary|Pharmacokinetics of AIN457: Observed Maximum Serum Concentration Following Drug Administration (Cmax)|Blood was drawn for PK analyses at baseline (prior to dosing), end of infusion, 1 hr and 2 hr after infusion, and during office visits in Weeks 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 26. The PK samples may have been taken at any time during each office visit, following the day of study drug infusion. This outcome measure shows the mean of all values resulting from each time point outlined above.|Day 182|The population included all AIN457A treatment group participants except for two participants who had a nontypical PK profile for Tmax, Cmax, CI and Vz.||ug/mL||Standard Deviation|Mean
765285|NCT00670007|Secondary|Time to First Pulmonary Exacerbation||Up to 2 years|ITT population.||years||95% Confidence Interval|Median
765260|NCT00669916|Secondary|Pharmacokinetics of AIN457: Time to Reach the Maximum Concentration After Drug Administration (Tmax)|Blood was drawn for PK analyses at baseline (prior to dosing), end of infusion, 1 hr and 2 hr after infusion, and during office visits in Weeks 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 26. The PK samples may have been taken at any time during each office visit, following the day of study drug infusion. This outcome measure shows the mean of all values resulting from each time point outlined above.|Day 182|The population included all AIN457 treatment group participants except for two participants who had a nontypical PK profile for Tmax, Cmax, CI and Vz.||days||Full Range|Median
765261|NCT00669916|Primary|Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Mean Score|The PASI assessed the extent of psoriasis on four body surface areas (head, trunk and upper limbs) and the degree of plaque erythema, scaling and thickness. The PASI score accounted for the extent of body surface area affected by the erythema, scaling and thickness and the severity of these measures. The score ranged from 0 (no disease) to 72 (maximal disease) where a reduction in PASI score from baseline indicates improvement. The percentage change was calculated by subtracting the week 4 values from the baseline values.The percentage change was calculated for each entire treatment group (not for each participant). A positive percentage change from baseline indicates improvement.|Baseline, Week 4|All participants||Percentage change in PASI mean score|||Number
765262|NCT00669942|Secondary|Disease Activity Score (DAS28) of Parts 2 and 3 Participants|The DAS28 is a composite score based on tender and swollen joint counts, C reactive protein (CRP) concentrations, and the participant's global disease activity based on a visual analogue scale (VAS). The tender joint count (based on 28 joints) was calculated by scoring several different aspects of tenderness as assessed by pressure and joint manipulation on physical examination. The information on various types of tenderness was then collapsed into a single tender versus non-tender dichotomy, and the number of joints that were classified as tender was recorded. The swollen joint count was calculated in the same manner. For CRP concentrations, blood samples were collected and sent to a central laboratory for assessment. For the VAS assessment, the participant used a 100 mm horizontal VAS to assess the severity of his or her arthritis where 0 = none and 100 = most severe. DAS28 scores range from <2.6 (disease remission) to >5.1 (high disease activity).|Day 43|The analysis was performed on the 10 mg and placebo treatment arms of the parts 2 and 3 participants.||scores on a scale||Standard Error|Mean
765263|NCT00669942|Secondary|Percentage of Parts 2 and 3 Participants Who Achieved ACR50 and ACR70|Clinical response to treatment was assessed according to ACR50 and ACR70 criteria. A participant was defined as an ACR50 or ACR70 responder if the following 3 conditions were met: 1) improvement of ≥50% or ≥ 70%, respectively, in the number of tender joints, 2) improvement of ≥50% or ≥ 70%, respectively, in the number of swollen joints and 3) improvement of ≥50% or ≥ 70%, respectively, in three of the following five domains: patient global assessment, physician global assessment, patient pain assessment, health assessment questionnaire (HAQ) and acute phase reactant|Day 43|The analysis was performed on the 10 mg and placebo treatment arms of the parts 2 and 3 participants.||Percentage of participants|||Number
765264|NCT00669942|Primary|Pharmacokinetics PK of AIN457: T1/2 in Parts 2 and 3 Participants|Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 23, 26, 29, 36, 43, 57, 71, 85, 99 and 113. On day 22, samples were collected pre-dose and 0.5, 1, 2, 4, 7 and 24 hours post infusion.|Day 113|Parts 2 and 3 participants who received AIN457A at 1 mg/kg, 3 mg/kg or 10 mg/kg were included in this analysis.||Day||Standard Deviation|Mean
765265|NCT00669942|Primary|Pharmacokinetics PK of AIN457: CL in Parts 2 and 3 Participants|Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 23, 26, 29, 36, 43, 57, 71, 85, 99 and 113. On day 22, samples were collected pre-dose and 0.5, 1, 2, 4, 7 and 24 hours post infusion.|Day 113|Parts 2 and 3 participants who received AIN457A at 1 mg/kg, 3 mg/kg or 10 mg/kg were included in this analysis.||Liters/day||Standard Deviation|Mean
765266|NCT00669942|Primary|Pharmacokinetics PK of AIN457: Vz in Parts 2 and 3 Participants|Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 23, 26, 29, 36, 43, 57, 71, 85, 99 and 113. On day 22, samples were collected pre-dose and 0.5, 1, 2, 4, 7 and 24 hours post infusion.|Day 113|Parts 2 and 3 participants who received AIN457A at 1 mg/kg, 3 mg/kg or 10 mg/kg were included in this analysis.||Liter||Standard Deviation|Mean
765267|NCT00669942|Primary|Pharmacokinetics PK of AIN457: AUClast and AUCinf in Parts 2 and 3 Participants|Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 23, 26, 29, 36, 43, 57, 71, 85, 99 and 113. On day 22, samples were collected pre-dose and 0.5, 1, 2, 4, 7 and 24 hours post infusion.|Day 113|Parts 2 and 3 participants who received AIN457A at 1 mg/kg, 3 mg/kg or 10 mg/kg were included in this analysis.||day*ug/mL||Standard Deviation|Mean
765268|NCT00669942|Primary|Pharmacokinetics PK of AIN457: Cmax in Parts 2 and 3 Participants|Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 23, 26, 29, 36, 43, 57, 71, 85, 99 and 113. On day 22, samples were collected pre-dose and 0.5, 1, 2, 4, 7 and 24 hours post infusion.|Day 113|Parts 2 and 3 participants who received AIN457A at 1 mg/kg, 3 mg/kg or 10 mg/kg were included in this analysis.||ug/mL||Standard Error|Mean
765269|NCT00669942|Primary|Pharmacokinetics PK of AIN457: Tmax in Parts 2 and 3 Participants|Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 23, 26, 29, 36, 43, 57, 71, 85, 99 and 113. On day 22, samples were collected pre-dose and 0.5, 1, 2, 4, 7 and 24 hours post infusion.|Day 113|Parts 2 and 3 participants who received AIN457A at 1 mg/kg, 3 mg/kg or 10 mg/kg were included in this analysis.||day||Full Range|Median
765270|NCT00669942|Primary|PK of AIN457: Terminal Elimination Half-life (T1/2) in Part 1 Participants|Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 23, 26, 29, 36, 43, 57, 71, 85, 99 and 113. On day 22, samples were collected pre-dose and 0.5, 1, 2, 4, 7 and 24 hours post infusion.|Day 113|Part 1 participants who received AIN457A at 0.3 mg/kg, 1 mg/kg, 3 mg/kg or 10 mg/kg were included in this analysis.||day||Standard Deviation|Mean
765286|NCT00670007|Secondary|Annual Rate in Subject Years of Pulmonary Exacerbations|Annual exposure‑adjusted incidence rate of pulmonary exacerbations.|Up to 2 years|ITT population.||Exacerbations/subject year||95% Confidence Interval|Number
765287|NCT00670007|Secondary|Number of Subjects With Pulmonary Exacerbations||Up to 2 years|ITT population.||participants|||Number
765271|NCT00669942|Primary|PK of AIN457: Systemic Clearance From Serum Following Intravenous Administration (CL) in Part 1 Participants|Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 23, 26, 29, 36, 43, 57, 71, 85, 99 and 113. On day 22, samples were collected pre-dose and 0.5, 1, 2, 4, 7 and 24 hours post infusion.|Day 113|Part 1 participants who received AIN457A at 0.3 mg/kg, 1 mg/kg, 3 mg/kg or 10 mg/kg were included in this analysis. One participant in the 0.3 mg/kg arm was not analyzed due to an atypical PK profile.||Liters/day||Standard Deviation|Mean
765272|NCT00669942|Primary|PK of AIN457: Volume of Distribution During the Terminal Phase Following Intravenous Elimination (Vz) in Part 1 Participants|Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 23, 26, 29, 36, 43, 57, 71, 85, 99 and 113. On day 22, samples were collected pre-dose and 0.5, 1, 2, 4, 7 and 24 hours post infusion.|Day 113|Part 1 participants who received AIN457A at 0.3 mg/kg, 1 mg/kg, 3 mg/kg or 10 mg/kg were included in this analysis. One participant in the 0.3 mg/kg arm was not analyzed due to an atypical PK profile.||Liters||Standard Deviation|Mean
765273|NCT00669942|Primary|PK of AIN457: Area Under the Serum Concentration-time Cure From Time Zero to the Time of Last Quantifiable Concentration (AUClast), Area Under the Serum Concentration-time Curve From Time Zero to (AUCinf) in Part 1 Participants|Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 23, 26, 29, 36, 43, 57, 71, 85, 99 and 113. On day 22, samples were collected pre-dose and 0.5, 1, 2, 4, 7 and 24 hours post infusion.|Day 113|Part 1 participants who received AIN457A at 0.3 mg/kg, 1 mg/kg, 3 mg/kg or 10 mg/kg were included in this analysis. One participant in the 0.3 mg/kg arm was not analyzed due to an atypical PK profile.||day*ug/mL||Standard Deviation|Mean
765274|NCT00669942|Primary|PK of AIN457: Observed Maximum Serum Concentration Following Drug Administration (Cmax) in Part 1 Participants|Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 23, 26, 29, 36, 43, 57, 71, 85, 99 and 113. On day 22, samples were collected pre-dose and 0.5, 1, 2, 4, 7 and 24 hours post infusion.|Day 113|Part 1 participants who received AIN457A at 0.3 mg/kg, 1 mg/kg, 3 mg/kg or 10 mg/kg were included in this analysis. One participant in the 0.3 mg/kg arm was not analyzed due to an atypical PK profile.||ug/mL||Standard Deviation|Mean
765275|NCT00669942|Primary|Pharmacokinetics (PK) of AIN457: Time to Reach the Maximum Concentration After Drug Administration (Tmax) in Part 1 Participants|Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 29, 36, 43, 57, 71, 85, 99 and 113.|Day 113|Part 1 participants who received AIN457A at 0.3 mg/kg, 1 mg/kg, 3 mg/kg or 10 mg/kg were included in this analysis. One participant in the 0.3 mg/kg arm was not analyzed due to an atypical PK profile.||day||Full Range|Median
765276|NCT00669942|Primary|Percentage of Parts 2 and 3 Participants Who Achieved American College of Rheumatology Response of 20 (ACR20)|Clinical response to treatment was assessed according to ACR20 criteria. A participant was defined as an ACR20 responder if the following 3 conditions were met: 1) ≥20% improvement in the number of tender joints, 2) ≥20% improvement in the number of swollen joint and 3) ≥20% improvement in three of the following five domains: patient global assessment, physician global assessment, patient pain assessment, health assessment questionnaire (HAQ) and acute phase reactant.|Day 43|The analysis was performed on the 10 mg and placebo treatment arms of the parts 2 and 3 participants.||percentage of participants|||Number
765277|NCT00669955|Secondary|Number of Patients With Bismuth Plasma Concentrations Above the Toxic Level|Tolerability of OBMT with respect to plasma bismuth concentrations: number of patients with bismuth concentrations above the toxic level (50 ug per liter)|Baseline (both arms), end of treatment (Day 11-14) and end of study (Day 70) OBMT arm only|Plasma bismuth concentrations were analysed in the OBMT arm only. The goal was to determine whether bismuth plasma concentrations would be of 50 ug/l or above at end of treatment, or at the end of study. The results report the number of patients having reached 50 ug/l in the OBMT arm at either of these timepoints.||participants|||Number
765278|NCT00669955|Secondary|Overall Compliance to Study Medications|Overall compliance: number of capsules dispensed - number of capsules returned/Number of prescribed capsules X 100. Percentages based on safety population|At the end of the treatment phase (days 8-14)|Safety population.||participants||Standard Deviation|Mean
765279|NCT00669955|Secondary|Metronidazole Resistance|Eradication rates in subset of patients infected with a bacterial strain confirmed as resistant to metronidazole at baseline. Resistance to metronidazole defined as Minimum Inhibitory Concentration (MIC) above 8 ug/ml|Measured at baseline|Per protocol population||participants|||Number
765280|NCT00669955|Secondary|Clarithromycin Resistance|Eradication rates in subset of patients infected with a bacterial strain confirmed as resistant to clarithromycin at baseline. Resistance to clarithromycin defined as Minimum Inhibitory Concentration (MIC) of 1 ug/ml and above|Measured at baseline|Per protocol analysis population||participants|||Number
765281|NCT00669955|Secondary|H. Pylori Eradication and Presence or Past History of Peptic Ulcers|Eradication rates in the subset of patients with peptic ulcer (current or past history) at baseline are reported based on the per protocol population. Eradication must be confirmed at week 6 and week 10 by a negative Urea Breath Test conducted within the allocated windows.|Week 6 and week 10 follow-up visits|Per protocol population.||Participants|||Number
765282|NCT00669955|Secondary|Number of Patients Experiencing Treatment Emergent Adverse Events.|"A treatment-emergent adverse event is defined as an event not present prior to exposure to the study medication or any event already present that worsens in either intensity or frequency following exposure to study medication up to 30 days after study discontinuation.
All safety analysis based on the safety population."|at the end of treatment (day 8-14), week 6 and wek 10 follow-up visits.|Safety population, described as all randomized patients having received at least one dose of study medication||Participants|||Number
765283|NCT00669955|Primary|Helicobacter Pylori Eradication Confirmed by Urea Breath Test|H. pylori Eradication defined as a negative C13-UBT (urea breath test) result at both Week 6 and Week 10 follow-up visits.|Week 6 and week 10 follow-up visits|No imputation method used, as this is the per protocol population, which excludes patients with missing values, or with protocol violations.||Participants|||Number
765288|NCT00670007|Secondary|Percent Change in Lung Function as Measured by Percent Predicted FEV1||From baseline up to 2 years|ITT population. Subjects may not have been included in all efficacy analyses because of missing efficacy assessments.||Percent change from baseline||Standard Deviation|Mean
765291|NCT00670007|Secondary|Change in Subject-reported Symptoms|Patient-reported symptoms were measured using the St George's Respiratory Questionnaire (SGRQ). SGRQ total, symptoms, activity and impact scores range from 0 to 100, with higher scores indicating more limitations, and change from baseline below zero (0) is favorable, indicating improvement.|From baseline to 2 years|ITT population. Subjects may not have been included in all efficacy analyses because of missing efficacy assessments.||units on a scale (change from baseline)||Standard Deviation|Mean
765292|NCT00670007|Secondary|Percent Change in Adjusted Lung Density|Percent change from baseline to 2 years as measured by centralized, standardized CT lung densitometry. CT scans were acquired at 2 inspiration states: TLC (ie, full inspiration) and FRC (ie, full expiration). Results were adjusted for total lung volume and are presented as point estimates for the average percent change in the early start and delayed start subgroups from an analysis of covariance (ANCOVA) model with country, treatment, and baseline lung density as fixed effects and inspiration state as a repeated random effect. The baseline is the last assessment from the preceding study CE1226_4001.|From baseline to 2 years|ITT population. Subjects may not have been included in all efficacy analyses because of missing efficacy assessments.||Percent change from baseline||Standard Deviation|Mean
765293|NCT00670007|Secondary|Absolute Change in Adjusted Lung Density|Absolute change from baseline to 2 years as measured by centralized, standardized CT lung densitometry. CT scans were acquired at 2 inspiration states: TLC (ie, full inspiration) and FRC (ie, full expiration). Results were adjusted for total lung volume and are presented as point estimates for the average absolute change in the early start and delayed start subgroups from an analysis of covariance (ANCOVA) model with country, treatment, and baseline lung density as fixed effects and inspiration state as a repeated random effect. The baseline is the last assessment from the preceding study CE1226_4001.|From baseline to 2 years|ITT population. Subjects may not have been included in all efficacy analyses because of missing efficacy assessments.||g/L||Standard Error|Least Squares Mean
765294|NCT00670007|Primary|Rate of Change of Adjusted Lung Density|As measured by centralized, standardized computer tomographic (CT) lung densitometry. CT scans were acquired at 2 inspiration states: TLC (Total Lung Capacity; ie, full inspiration) and FRC (Functional Residual Capacity; ie, full expiration). Results were adjusted for total lung volume and are presented as point estimates for the average rate of decline in the early start and delayed start subgroups from a linear random regression model with country, inspiration state (only for 'TLC and FRC state'), time (time elapsed since Day 1 [CE1226_4001]), treatment and treatment by time interaction as fixed effects and subject and subject by time interaction as random coefficients.|Up to 2 years|Intention-to-treat (ITT) population. Subjects may not have been included in all efficacy analyses because of missing efficacy assessments.||g/L per year||Standard Error|Least Squares Mean
765295|NCT00670111|Secondary|Peak Volume of Oxygen Uptake (Peak VO2) - Rate Adaptive Pacing (RAP) On at Six Months vs. Rate Adaptive Pacing (RAP) Off at One Month.|"Each patient had RAP therapy On from one through six months. This endpoint evaluated Peak VO2 measured at 6 months (RAP On) vs. Peak VO2 measured at 1 month without RAP therapy (RAP Off).All participants were RAP On for months 1 through 6. All participants were 'Rap On' for months 6 to 12."|6 months post implant|"The following were required for a patient's dataset to be included in the analysis:
2 CPX tests had to be performed (1M with RAP Off, 6M with RAP On [RAP was On from 1M to 6M]),
Each CPX test had to result in RER ≥ 1.05,
Trending data from the disk had to have been obtained during each CPX test."||ml/kg/min||Standard Deviation|Mean
765296|NCT00670111|Primary|Peak Volume of Oxygen Uptake (Peak VO2) - Rate Adaptive Pacing (RAP) On at One Month vs. Rate Adaptive Pacing (RAP) Off at One Month.|Randomized therapy order cross-over comparison at 1 month post-implant. Each patient evaluated for endpoint with and without RAP therapy at this time.|1 month post implant|"The following were required for a patient's dataset to be included in the analysis:
2 CPX tests had to be performed at 1M (RAP On & RAP Off),
Each 1M CPX test had to result in RER ≥ 1.05,
Trending data from the disk had to have been obtained during each 1M CPX test."||ml/kg/min||Standard Deviation|Mean
765297|NCT00670202|Primary|Decrease in Rho/ROCK Expression With Concordant Increase in eNOS Expression/Activity in Carotid Specimens.|We were going to compare Rho/ROCK expression and eNOS expression/activity in carotid specimens obtained from patients treated with fasudil and compare those to specimens obtained from patients treated with placebo. We anticipated that Rho/ROCK expression and activity would be decreased in spcimens obtained from fasudil treated patients compared to specimens obtained from patients treated with placebo. We also anticipated that eNOS expression and activity would be increased in specimens obtained from patients treated with fasudil compared to specimens obtained from patients treated with placebo.|>= 2 weeks||||||
765298|NCT00670228|Secondary|Biomarkers of Inflammation Measurement: CRP (C-Reactive Protein)||At Day 60|Analysis was performed on the Modified Intention To Treat (MITT) population which includes all randomized subjects who took at least one dose of the study medication, undergone PCI procedure at hospital admission, and had a valid post-PCI infarct size.||mg/L||Standard Deviation|Mean
765299|NCT00670228|Secondary|Occurrence of the Major Adverse Cardiovascular Events (MACE)|"MACE:
Cardiac death, New onset or worsening congestive heart failure (>24 h post-admission) event evaluating using New York Heart Association (NYHA) Class II or greater Non-fatal Myocardial Infarction, Severe arrhythmia, Stroke/TIA (Transient Ischemic Attack), Cardiogenic shock, Catheterization/revascularization, Unstable angina leading to hospitalisation"|At Day 60|Analysis was performed on the safety population which includes all subjects who received any study treatment. All subjects in this population were analyzed according to the actual treatment they received.||events|||Number
765300|NCT00670228|Secondary|Left Ventricular (LV) Function Evaluated by Cardiac Magnetic Resonance Imaging (MRI)|Due to study early termination and the limited number of randomized subjects, descriptive statistics for the Day 3 Ejection Fraction were selected for presentation instead of for Day 60 as initially planned.|At Day 3|Analysis was performed on the Modified Intention To Treat (MITT) population which includes all randomized subjects who took at least one dose of the study medication, undergone PCI procedure at hospital admission, and had a valid post-PCI infarct size.||percentage of Ejection Fraction||Standard Deviation|Mean
765301|NCT00670228|Primary|Infarct Size Absolute Change From Baseline at Day 60|Infarct size is measured by cardiac Magnetic Resonance Imaging (MRI) as the percentage of Left Ventricular (LV) mass.|From baseline at Day 60|Analysis was performed on the Modified Intention To Treat (MITT) population which includes all randomized subjects who took at least one dose of the study medication, undergone PCI procedure at hospital admission, and had a valid post-PCI infarct size.||percentage of LV mass change||Standard Deviation|Mean
765307|NCT00670267|Secondary|Change in Asthma Control Questionnaire (ACQ) Score Compared to Baseline|In the E.F. Juniper Asthma Control Questionnaire, a lower number reflects better control of asthma symptoms. A positive change in ACQ score reflects a reduction in control compared to baseline; conversely, a negative change in ACQ score reflects an increase in control compared to baseline. The ACQ has 7 questions (the top scoring 5 symptoms, FEV1% pred. and daily rescue bronchodilator use). Patients are asked to recall how their asthma has been during the previous week and to respond to the symptom and bronchodilator use questions on a 7-point scale (0=no impairment, 6= maximum impairment). Clinic staff score the FEV1% predicted on a 7-point scale. The questions are equally weighted and the ACQ score is the mean of the 7 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled).|Baseline to end of study (105 days)|||units on a scale||Standard Deviation|Mean
765308|NCT00670267|Secondary|Percent Change in FEV1% Predicted From Baseline to End of Study||Baseline to end of study (105 days)|||percent change in FEV1% predicted||Standard Deviation|Mean
765309|NCT00670267|Secondary|Change in Airway Hyper-reactivity Compared to Baseline (Change in PC20 Doubling Dose by Methacholine Challenge)|Bronchoprovocation assessment was done by doubling doses of methacholine in accordance with the methodology recommended by the American Thoracic Society in the official policy statement adopted by the ATS Board of Directors, July 1999 (Guidelines for Methacholine and Exercise Challenge Testing-1999).|Baseline to end of study (105 days)|Analysis excludes one early termination subject||mg/mL||Standard Deviation|Mean
765310|NCT00670267|Primary|Daily Dose at Study Termination Across Participants|The outcome measure describes the final daily dose achieved by the subjects in this study. The subjects described below who finished on less than the highest dose (i.e., 1.25, 5, and 10mgs) had all been down-titrated one dose (i.e., from 2.5, 10, and 20mgs) prior to completing the study on the dose reported.|Baseline to end of study (105 days)|||participants|||Number
765311|NCT00670267|Primary|Mean Daily Dose at Study Termination Across Participants|The outcome measure describes the mean daily dose achieved by the subjects at study termination. This data includes one subject who terminated early, having reached 2.5mgs and subsequently reducing to 1.25mgs prior to dropping out.|Baseline to end of study (105 days)|||mg||Standard Deviation|Mean
765312|NCT00670306|Primary|IPSS Change From Baseline|International Prostate Symptom Score (IPSS) Patient Questionnaire assessing 7 items (incomplete voiding, frequency, intermittency, urgency, weak stream, hesitancy, nocturia) on a scale from 0 (best) to 5 (worst); total range: 0 - 35 points; absolute change from baseline to Week 26|Baseline and Week 26|Intention to treat (ITT) analysis with Last Observation Carried Forward (LOCF) imputation technique||Units on a scale||Standard Deviation|Mean
765313|NCT00676182|Primary|Beck Depression Inventory Score (Total Score)|Range for Total Score: 0-63 Directionality: Higher score means more depression-related symptoms.|Baseline, 6 Months, 12 Months|Only veterans with TBI and comorbid PTSD with data at the specified time point were analyzed.||units on a scale||Standard Deviation|Mean
765314|NCT00676182|Primary|Alcohol Use Disorders Identification Test (AUDIT) (Total Score)|Range for Total Score: 0-40 Directionality: Higher score means more alcohol use.|Baseline, 6 Months, 12 Months|Only veterans with TBI and comorbid PTSD with data at the specified time point were analyzed.||units on a scale||Standard Deviation|Mean
765315|NCT00676182|Primary|Modified PTSD Symptom Scale: Self-Report - Severity|Range for Total Score: 0 - 68 Directionality: Higher score means more PTSD-related symptoms.|Baseline, 6 Months, 12 Months|Only veterans with TBI and comorbid PTSD with data at the specified time point were analyzed.||units on a scale||Standard Deviation|Mean
765316|NCT00676182|Primary|Modified PTSD Symptom Scale: Self-Report - Frequency (Total Score)|Range for Total Score: 0-68 Directionality: Higher score means more PTSD-related symptoms.|Baseline, 6 Months, 12 Months|Veterans with TBI and comorbid PTSD with data at the specified time point were analyzed.||units on a scale||Standard Deviation|Mean
765317|NCT00676182|Primary|PTSD Checklist Military Form (PCL-M) (Total Score)|Range for total score: 17- 85 Directionality for total score: Higher score means experiencing more PTSD-related problems.|Baseline, 6 Months, 12 Months|Veterans with TBI with comorbid PTSD who were analyzed at the specified time point.||units on a scale||Standard Deviation|Mean
765318|NCT00676182|Primary|Patient Competency Rating Scale (PCRS) (Total Score)|Range for total score: 30 - 150 Directionality for total score: higher score means higher competency (can do things with greater ease)|Baseline, 6 Months, 12 Months|Only participants with data at the specified time were analyzed.||units on a scale||Standard Deviation|Mean
765319|NCT00676182|Primary|Craig Handicap Assessment and Reporting Technique (CHART)|"Ranges for Subscales: 0 - 100 Physical Independence: 4 -100 Cognitive Independence: 0 -100 Mobility: 0 -100 Occupation: 0 -100 Social Integration: 0 -100 Economic Self Sufficiency: 0-100
Directionality: for each subscale, higher score means more independence; lower score means needs more assistance."|Baseline, 6 Months, 12 Months|Only participants with data at the specified time points were analyzed.||units on a scale||Standard Deviation|Mean
765320|NCT00676182|Primary|Functional Independence MeasureTM (FIM)/Functional Assessment Measure (FAM) (Total Score)|Range: 30 - 210 FIMFAM Total Score: Higher value indicates higher function.|Baseline, 6 months, 12 months|Only participants with data at the specified time points are included in the analysis.||units on a scale||Standard Deviation|Mean
765321|NCT00676195|Secondary|Glutathione Metabolism Intermediates in Peripheral Blood Measured by High-performance Liquid Chromatography||12 weeks|No analyses were conducted since it is an open-label trial and data was analyzed in the double-blind phase. Additionally, the main reason for the this phase is to allow participants who were on the placebo during the double-blind phase of NCT00627705 to receive the compound.|||||
765322|NCT00676195|Secondary|Irritability Subscale of the Aberrant Behavior Checklist (ABC)||4, 8, and 12 weeks|No analyses were conducted since it is an open-label trial and data was analyzed in the double-blind phase. Additionally, the main reason for the this phase is to allow participants who were on the placebo during the double-blind phase of NCT00627705 to receive the compound.|||||
765323|NCT00676195|Secondary|Sensory Profile Questionnaire (SPQ)||12 weeks|No analyses were conducted since it is an open-label trial and data was analyzed in the double-blind phase. Additionally, the main reason for the this phase is to allow participants who were on the placebo during the double-blind phase of NCT00627705 to receive the compound.|||||
765324|NCT00676195|Secondary|Social Responsiveness Scale (SRS)||12 weeks|No analyses were conducted since it is an open-label trial and data was analyzed in the double-blind phase. Additionally, the main reason for the this phase is to allow participants who were on the placebo during the double-blind phase of NCT00627705 to receive the compound.|||||
765325|NCT00676195|Primary|Number of Participants With Adverse Events Reported on the Dosage Record and Treatment Emergent Symptom Scale (DOTES)|Number of Participants with adverse events reported on the Dosage Record and Treatment Emergent Symptom Scale (DOTES) during the course of the study as measured at time points (4, 8, and 12 weeks).|4, 8, and 12 weeks|||number of participants|||Number
765326|NCT00676208|Secondary|Change in Professionals' Attitudes About Diabetes|The University of Michigan's Research and Training Center's Diabetes Attitude Scale was used. There are 33 items and the response format is a 5 point Likert Scale ranging from 'strongly disagree'(1) to 'strongly agree'(5). A higher score means more positive attitudes toward diabetes and its treatment (e.g., psychosocial impact of diabetes; value of tight glucose control).The total score is computed by summing individual items and ranges from 0 to 165. Post-pre total scores were used with positive and higher values indicating greater favorable change.|Pre-intervention and Post-intervention at 1 month|||units on a scale||Standard Deviation|Mean
765327|NCT00676208|Primary|Change in Confidence in Ability to Perform Teamwork|A three item scale was used to assess confidence in ability to convey logic of recommendations to other providers, explain one's distinctive perspective, and be accountable to patients for a decision made by a colleague from another discipline. The responses for each item ranged from 'not at all confident' (0) to 'very confident' (4), with higher values indicating more confidence. The total scale ranged from 0 to 16 with higher being more confident. Difference scores were analyzed (post-pre) with positive and higher values indicating more favorable change.|Pre-intervention and Post-Intervention at 1 month|||units of a scale||Standard Deviation|Mean
765328|NCT00676338|Secondary|Change in Diastolic Blood Pressure From Baseline to Week 26.|Change in Diastolic Blood Pressure from baseline to Week 26.|Baseline, Week 26|ITT population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. All scheduled post-baseline measurements were included in the analysis, with no imputation of missing data other than that inherent in the MMRM model was used.||mmHg||Standard Error|Least Squares Mean
765329|NCT00676338|Secondary|Change in Systolic Blood Pressure From Baseline to Week 26.|Change in Systolic Blood Pressure from baseline to Week 26.|Baseline, Week 26|ITT population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. All scheduled post-baseline measurements were included in the analysis, with no imputation of missing data other than that inherent in the MMRM model was used.||mmHg||Standard Error|Least Squares Mean
765330|NCT00676338|Secondary|Assessment on Event Rate of Treatment-Emergent Minor Hypoglycemic Events|Minor hypoglycemia is defined as a sign or symptom associated with hypoglycemia that is either self-treated by the patient or resolves on its own AND has a concurrent finger stick blood glucose <3.0 mmol/L (54 mg/dL) and not classified as major hypoglycemia. Mean event rate = total number of events for all subjects in a treatment regimen / the total number of subject years of exposure for all subjects in that treatment. Standard error = square root of (total number of events / (subject years of exposure)**2).|Baseline to Week 26|ITT population.||events per subject-year||Standard Error|Mean
765331|NCT00676338|Secondary|Assessment on Event Rate of Treatment-emergent Major Hypoglycemic Events|Major hypoglycemia is defined as any event that has symptoms consistent with hypoglycemia resulting in loss of consciousness or seizure that shows prompt recovery in response to administration of glucagon or glucose, or documented hypoglycemia (blood glucose <3.0 mmol/L [54 mg/dL]) requiring the assistance of another person because of severe impairment in consciousness or behavior (whether or not symptoms of hypoglycemia are detected by the patient). Mean event rate = total number of events for all subjects in a treatment regimen / the total number of subject years of exposure for all subjects in that treatment. Standard error = square root of (total number of events / (subject years of exposure)**2).|Baseline to Week 26|ITT population.||events per subject-year||Standard Error|Mean
765332|NCT00676338|Secondary|Ratio of Fasting Triglycerides at Week 26 to Baseline|Ratio of Fasting Triglycerides (measured in mmol/L) at Week 26 to baseline. Log(Post-baseline Triglycerides) - log(Baseline Triglycerides); change from baseline to Week 26 is presented as ratio of endpoint to baseline.|Baseline, Week 26|ITT population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. Missing data at endpoint was imputed using LOCF approach.||ratio||Standard Error|Least Squares Mean
765333|NCT00676338|Secondary|Change in Fasting High-Density Lipoprotein (HDL) From Baseline to Week 26|Change in Fasting HDL from baseline to Week 26.|Baseline, Week 26|ITT population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. All scheduled post-baseline measurements were included in the analysis, with no imputation of missing data other than that inherent in the MMRM model was used.||mmol/L||Standard Error|Least Squares Mean
765334|NCT00676338|Secondary|Change in Fasting Total Cholesterol (TC) From Baseline to Week 26|Change in Fasting TC from baseline to Week 26.|Baseline, Week 26|ITT population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. All scheduled post-baseline measurements were included in the analysis, with no imputation of missing data other than that inherent in the MMRM model was used.||mmol/L||Standard Error|Least Squares Mean
765335|NCT00676338|Secondary|Change in Body Weight From Baseline to Week 26|Change in Body Weight from baseline to Week 26.|Baseline, Week 26|ITT population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. All scheduled post-baseline measurements were included in the analysis, with no imputation of missing data other than that inherent in the MMRM model was used.||kg||Standard Error|Least Squares Mean
765336|NCT00676338|Secondary|Change in Fasting Serum Glucose (FSG) From Baseline to Week 26|Change in FSG from baseline to Week 26.|Baseline, Week 26|ITT population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. All scheduled post-baseline measurements were included in the analysis, with no imputation of missing data other than that inherent in the MMRM model was used.||mmol/L||Standard Error|Least Squares Mean
765337|NCT00676338|Primary|Percentage of Patients Achieving HbA1c <=7% at Week 26|Percentage of patients achieving HbA1c <=7% at Week 26 (for patients with baseline HbA1c >7%).|Baseline, Week 26|ITT subjects with baseline HbA1c>7%. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. Missing data at endpoint was imputed using last observation carried forward (LOCF) approach.||percentage of patients|||Number
765338|NCT00676338|Primary|Change in HbA1c From Baseline to Week 26|Change in HbA1c from baseline to Week 26.|Baseline, Week 26|Intent to treat (ITT) population consisted of all randomized patients who had taken at least one dose of study drug. All scheduled post-baseline measurements were included in the analysis. Unscheduled visit observations were carried forward to the next scheduled visits.||percentage of total hemoglobin||Standard Error|Least Squares Mean
765339|NCT00676364|Primary|Pain From Venipuncture|"Pain was measured immediately after venipuncture by the participant using the six-point FACES scale. FACES in not an acronym, but rather a description of a pain scale that uses pictures of faces in various states of pain. The FACES pain scale is a common scale used to measure pain with scores on a scale. The scale we used had six points from zero (0) to five (5) indicating different levels of pain. Lower scores indicate lower levels of pain, and higher scores indicate higher levels of pain."|Pain was measured immediately after venipuncture.|We determined that we will need to enroll 43 children in each group, for a power of .80, alpha=0.05. We used a per protocol analysis.||scores on a scale||Standard Deviation|Mean
765340|NCT00676364|Secondary|Anxiety of Venipuncture|Participant anxiety was measured by the study participant and the objective observer before (anticipatory), during (venipuncture) and after (recovery) venipuncture using a validated visual analog scale (VAS). The VAS is a validated scale that is used to detect small changes in many types of observations. The scale ranges from 0-100 scores on a scale, and here the higher scores indicate higher anxiety levels. Only the participant's mean venipuncture (during venipuncture) anxiety scores are presented in outcome measure results here.|During venipuncture|We determined that we will need to enroll 43 children in each group, for a power of .80, alpha=0.05. We used a per protocol analysis.||scores on a scale||Standard Deviation|Mean
765341|NCT00676403|Secondary|Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores|"Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health), 2 summary scores (physical component and mental component), and a self-evaluated change in health status. Self-evaluated change in health status: 5 Likert-type response categories ranging from much worse now to much better now. Recall period: month prior to the assessment."|Baseline, Week 6|ITT; N = number of subjects in a treatment group.||participants|||Number
765342|NCT00676403|Secondary|Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6|Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health), 2 summary scores (physical component and mental component), and a self-evaluated change in health status. Subscale and summary scores range: 0-100. Higher subscale and summary scores = better health status. Recall period: month prior to the assessment. Change from baseline = score at observation minus score at baseline.|Baseline, Week 6|ITT; N = Subjects who were randomized and received at least one dose of study drug; baseline n = subjects who were randomized and received at least one dose of study drug, had baseline and post-baseline values.||scores on scale||Standard Error|Least Squares Mean
765343|NCT00676403|Secondary|Restless Leg Syndrome - Quality of Life Scale (RLS-QoL): Change From Baseline to Week 6|RLS QoL: subject-rated instrument used to assess the impact of RLS on quality of life and health status function (symptom severity, daily activity, social functioning, sleep, concentrating and decision making, traveling, sexual activity, and work) yielding a summary score ranging from 0-100. Higher scores reflect better quality of life. Recall period is the month prior to the assessment. Change from baseline = score at observation minus score at baseline.|Baseline, Week 6|ITT; N = Subjects who were randomized and received at least one dose of study drug; baseline n = subjects who were randomized and received at least one dose of study drug, and had baseline and post-baseline values.||scores on scales||Standard Error|Least Squares Mean
765344|NCT00676403|Secondary|Medical Outcomes Study - Sleep Scale (MOSS-SS): Optimal Sleep; Observed Cases Summarized by Week|MOS-SS: subject-rated instrument used to assess the key constructs of sleep over the past week; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Optimal Sleep subscale is derived from sleep quantity average hours of sleep each night during the past week. Number of subjects with response: YES (Optimal) if sleep quantity was 7 or 8 hours of sleep per night.|Week 1, Week 2, Week 4, Week 6|ITT||participants|||Number
765345|NCT00676403|Secondary|Medical Outcomes Study - Sleep Scale (MOSS-SS): 9-Item Sleep Problems Index; Observed Change From Baseline|MOS-SS: subject-rated instrument used to assess the key constructs of sleep over the past week; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Composite index scores are sleep problems Index I (6 items) and sleep problems Index II (9 items). 9-Item Sleep Problems Index range: 0-100; lower score indicates fewer sleep problems. Change from baseline = score at observation minus score at baseline.|Baseline, Week 1, Week 2, Week 4, Week 6|ITT; baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit.||scores on scale||Standard Error|Least Squares Mean
765346|NCT00676403|Secondary|Medical Outcomes Study - Sleep Scale (MOSS-SS): 6-Item Sleep Problems Index; Observed Change From Baseline|MOS-SS: subject-rated instrument used to assess the key constructs of sleep over the past week; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Sleep Problems Index I (6 items): composite index score range 0-100; lower score indicates fewer sleep problems. Change from baseline = score at observation minus score at baseline.|Baseline, Week 1, Week 2, Week 4, Week 6|ITT; baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit.||scores on scale||Standard Error|Least Squares Mean
765347|NCT00676403|Secondary|Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Quantity Subscale; Observed Change From Baseline|MOS-SS: subject-rated instrument used to assess the key constructs of sleep over the past week; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Sleep Quantity (1 item) subscale score range: 0-24 hours. Change from Baseline in number of hours slept. Change from baseline = score at observation minus score at baseline.|Baseline,, Week 1, Week 2, Week 4, Week 6|ITT; baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit.||scores on scale||Standard Error|Least Squares Mean
765370|NCT00676806|Secondary|Incidence of Chronic GVHD||After Day +100|No subject receiving reduced intensity conditioning was evaluable for the event of chronic GVHD (0/3 subjects survived to day +100)||participants|||Number
765348|NCT00676403|Secondary|Medical Outcomes Study - Sleep Scale (MOSS-SS): Somnolence Subscale; Observed Change From Baseline|MOS-SS: subject-rated instrument used to assess the key constructs of sleep over the past week; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Sleep Somnolence Subscale score range: 0-100; higher score indicates less somnolence. Change from baseline = score at observation minus score at baseline.|Baseline,, Week 1, Week 2, Week 4, Week 6|ITT; baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit.||scores on scale||Standard Error|Least Squares Mean
765349|NCT00676403|Secondary|Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Adequacy Subscale; Observed Change From Baseline|MOS-SS: subject-rated instrument used to assess the key constructs of sleep; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Sleep Adequacy Subscale score range: 0-100; higher scores indicates greater sleep adequacy. Change from baseline = score at observation minus score at baseline.|Baseline, Week 1, Week 2, Week 4, Week 6|ITT; baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit.||scores on scale||Standard Error|Least Squares Mean
765350|NCT00676403|Secondary|Medical Outcomes Study - Sleep Scale (MOSS-SS): Awaken Short of Breath or With Headache Subscale; Observed Change From Baseline|MOS-SS: subject-rated instrument used to assess the key constructs of sleep over the past week ; comprised of 12 items yielding 7 subscale scores and 2 composite index scores. Awaken Short of Breath or with Headache subscale score range: 0-100; lower score indicates less difficulty. Change from baseline = score at observation minus score at baseline.|Baseline, Week 1, Week 2, Week 4, Week 6|ITT; baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit.||scores on scale||Standard Error|Least Squares Mean
765351|NCT00676403|Secondary|Medical Outcomes Study - Sleep Scale (MOSS-SS): Snoring Subscale; Observed Change From Baseline|MOS-SS: subject-rated instrument used to assess the key constructs of sleep; assesses sleep quantity and quality over the past week. Comprised of 12 items yielding 7 subscale scores and 2 composite index scores. Snoring Subscale score (1 item): range 0-100, lower score indicates less snoring. Change from baseline = score at observation minus score at baseline.|Baseline, Week 1, Week 2, Week 4, Week 6|ITT; baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit.||scores on scale||Standard Error|Least Squares Mean
765352|NCT00676403|Secondary|Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Disturbance Subscale; Observed Change From Baseline|MOS-SS: subject-rated instrument used to assess the key constructs of sleep quantity and quality over the past week; comprised of 12 items yielding 7 subscale scores and 2 composite index scores. Sleep Disturbance Subscale score (4 items): range 0-100; lower score indicates less disturbance. Change from baseline = score at observation minus score at baseline.|Baseline, Week 1, Week 2, Week 4, Week 6|ITT, Baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit.||scores on scale||Standard Error|Least Squares Mean
765353|NCT00676403|Secondary|Subjective Sleep Questionnaire: Quality of Sleep Subscale; Observed Change From Baseline|Subjective Sleep Questionnaire (SSQ): subject-rated instrument used to assess sleep behavior; measures sleep quantity and quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, and quality of sleep. Quality of sleep subscale: visual analog scale ranging from 1 (very poor) to 100 (excellent) completed by the subject 30 minutes after waking; recall period is the night before. Change from baseline = score at observation minus score at baseline.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6|ITT; baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit.||scores on scale||Standard Error|Least Squares Mean
765354|NCT00676403|Secondary|Subjective Sleep Questionnaire: Total Wake Time After Sleep Onset Subscale; Observed Change From Baseline|Subjective Sleep Questionnaire (SSQ): subject-rated instrument used to assess sleep behavior; measures sleep quantity and quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, and quality of sleep. Total wake time after sleep onset subscale (in minutes): numerical rating completed by the subject 30 minutes after waking; recall period is the night before. Reduction = improvement. Change from baseline = score at observation minus score at baseline.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6|ITT; baseline statistics were calculated only for subjects who had a non-missing change from baseline at at least one post-baseline visit.||minutes||Standard Error|Least Squares Mean
765355|NCT00676403|Secondary|Subjective Sleep Questionnaire: Number of Awakenings Subscale; Observed Change From Baseline|Subjective Sleep Questionnaire (SSQ): subject-rated instrument used to assess sleep behavior; measures sleep quantity and quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, and quality of sleep. Number of awakenings subscale: numerical rating completed by the subject 30 minutes after waking; recall period is the night before. Fewer awakenings reflect better quality of sleep. Change from baseline = score at observation minus score at baseline.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6|ITT; baseline statistics were calculated only for subjects who had a non-missing change from baseline in at least one post-baseline visit.||awakenings||Standard Error|Least Squares Mean
765356|NCT00676403|Secondary|Subjective Sleep Questionnaire: Hours of Sleep Subscale; Observed Change From Baseline|Subjective Sleep Questionnaire (SSQ): subject-rated instrument used to assess sleep behavior; measures sleep quantity and quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, and quality of sleep. Hours of sleep subscale reflects change in hours of sleep from baseline. Numerical rating completed by the subject 30 minutes after waking; recall period is the night before.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6|ITT; baseline statistics were calculated only for subjects who had a non-missing change from baseline at at least one post-baseline visit.||hours||Standard Error|Least Squares Mean
765371|NCT00676806|Secondary|Infectious Complications in UCB Recipients.||Day +100|||participants|||Number
765372|NCT00676806|Secondary|Incidence of Acute GVHD||Day +100|||participants|||Number
765373|NCT00676806|Secondary|Proportion of Subjects With Platelet Engraftment|Proportion of patients engrafting by days +45, +90, and +180.|+45, 90, and 180 days|||participants|||Number
765357|NCT00676403|Secondary|Subjective Sleep Questionnaire (SSQ): Latency Subscale; Observed Change From Baseline|Subjective Sleep Questionnaire (SSQ): subject-rated instrument used to assess sleep behavior; measures sleep quantity and quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, and quality of sleep. Latency subscale (time to fall asleep [in minutes]): numerical rating completed by the subject 30 minutes after waking; recall period is the night before. Lower score reflects greater ease (shorter time) in falling asleep. Change from baseline = score at observation minus score at baseline.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6|ITT; baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit.||minutes||Standard Error|Least Squares Mean
765358|NCT00676403|Secondary|Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)|CGI-S Scale: 7-point clinician rated scale to assess severity of subject's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected.|Baseline, Week 1, Week 2, Week 4, Week 6, Last Observation Carried Forward (LOCF)|ITT; N=number of subjects in a treatment group. LOCF: Last Observation Carried Forward.||participants|||Number
765359|NCT00676403|Secondary|Number of Subjects Responding to Treatment as Assessed by the Clinical Global Impression - Improvement Scale (CGI-I)|Clinical Global Impression - Improvement Scale (CGI-I): 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. Number of subjects responding to treatment at Week 6 with respect to dose level. CGI-I Responders = subjects who reported CGI-I scores of very much improved or much improved.|Week 6|ITT; N=number of subjects in a treatment group; n=number of subjects with a clinical Global Impressions Improvement (CGI-I) rating.||participants|||Number
765360|NCT00676403|Primary|Change From Baseline in Restless Leg Syndrome (RLS) International Restless Leg Group Symptom Severity Rating Scale (IRLS) Total Score at Week 6|IRLS: Subject-rated instrument to assess RLS symptom severity and impact on daily living; 10 items yielding 2 subscale scores and 1 global (total) score. Subscale scores: symptom severity (6 items) and impact on daily living (3 items), with item 5 (daytime somnolence due to RLS) loaded equally on both subscales. Global score: calculated from all 10 items. Subscale score ranges: symptom severity 0-24, impact of daily living 0-12; global score range: 0-40. Lower scores reflect lower severity and better quality of life. Change from baseline = score at observation minus score at baseline.|Baseline, Week 6|ITT. Baseline statistics were calculated only for subjects who had a non-missing change from baseline at at least one post-baseline visit. Recall period = week prior to assessment.||scores on scale||Standard Error|Least Squares Mean
765361|NCT00676455|Secondary|Tumor Size Will be Measured by CT (by the MeVis Volumetry Software and Correlated With On-going Treatment Plan.|"Tumor size will be measured by CT (by the MeVis Volumetry Software and correlated with on-going treatment plan.
Correlation of the tumor growth with clinical treatment will be assessed. Tumor size will be expressed in volume. Specifically Three dimensional volume Volume of Interest(VOI)will be calculated and correlated with the treatment protocol. Measure = tumor volume."|As long as treatment is being assessed by CT examinations|Due to low enrollment no analysis was conducted due to the lack of participants.|||||
765362|NCT00676455|Primary|This Study Assessed the Ability of MeVis™ Volumetry Software to Reproducibly Measure the Changes in Metastatic Hepatic and Pulmonary Lesions|"Due to the low enrollment for this project the data collected is not sufficient to provide any significant conclusion to the primary outcome hypothesis.
Due to lack of participants. No significant findings are reported at this time."|As long as treatment is being assessed by CT examinations|Due to low enrollment no analysis was conducted due to the lack of participants.|||||
765363|NCT00676494|Primary|Major Adverse Events (MAEs) Within 30 Days|Major adverse events (MAEs) are any death, target vessel revascularization (TVR), target lesion revascularization (TLR), myocardial infarction (MI), or amputation of the treated limb that occurred within 30 days of the index procedure.|30 days|Number of study participants was statistically determined by protocol-defined endpoints. Analysis endpoints were assessed via summary statistics and 95% confidence intervals. No p-values were generated and no statistical inferences asserted regarding point estimates or confidence limits generated for any additional post-hoc data analysis.||Participants|||Number
765364|NCT00676494|Secondary|Freedom From Target Lesion Revascularization (TLR) at 6 Months|Number of patients that did not require target lesion revascularization 6 months after index procedure.|6 months|Number of study participants was statistically determined by protocol-defined endpoints. Analysis endpoints were assessed via summary statistics and 95% confidence intervals. No p-values were generated and no statistical inferences asserted regarding point estimates or confidence limits generated for any additional post-hoc data analysis.||participants|||Number
765365|NCT00676494|Secondary|Average Ankle Brachial Index (ABI) at 6 Months|Ankle Brachial Index (ABI) is the ratio of the blood pressure in the lower legs to the blood pressure in the arms. Compared to the arm, lower blood pressure in the leg is a symptom of peripheral artery disease (PAD). Range: Normal arteries (1.0 - 1.2) to Severe arterial disease (under 0.5)|6 months|Number of study participants was statistically determined by protocol-defined endpoints. Analysis endpoints were assessed via summary statistics and 95% confidence intervals. No p-values were generated and no statistical inferences asserted regarding point estimates or confidence limits generated for any additional post-hoc data analysis.||units on scale||Standard Deviation|Mean
765366|NCT00676494|Secondary|Average Rutherford Classification Score at 6 Months|Rutherford Classification measures lower limb peripheral arterial disease (PAD) by evaluating and rating symptoms. Score: 0 (no symptoms or discomfort in leg) to 6 (Tissue loss or gangrene in leg)|6 months|Number of study participants was statistically determined by protocol-defined endpoints. Analysis endpoints were assessed via summary statistics and 95% confidence intervals. No p-values were generated and no statistical inferences asserted regarding point estimates or confidence limits generated for any additional post-hoc data analysis.||Score on scale||Standard Deviation|Mean
765367|NCT00676793|Primary|Change in Serum HGF and Breast Cancer|Change in serum HGF from baseline to post Polyphenol E treatment.|Baseline and 4 to 6 weeks|Number of participants for analysis was determined per protocol.||pg/ml||Inter-Quartile Range|Median
765368|NCT00676793|Primary|Change in Serum VEGF in Breast Cancer|Change in serum VEGF from baseline to post treatment with polyphenon E.|Baseline and 4 to 6 weeks|Number of participants for analysis was determined per protocol.||pg/ml||Inter-Quartile Range|Median
765374|NCT00676806|Primary|Number of Participants With Neutrophil Engraftment|Number of participants with neutrophil engraftment receiving umbilical cord blood for hematopoietic rescue following myeloablative or non-myeloablative conditioning|+45 and 90 days|Only 2 subjects were evaluable from each group at the +45 day mark. The same number were evaluable at the +90 day mark.||participants|||Number
765375|NCT00676897|Secondary|Inflammatory Marker Levels|Change in inflammatory marker levels over time from time zero to time 24 hour.|over 24 hours (time zero and time 24 hours)|||pg/mL and ng/mL||Standard Deviation|Mean
765376|NCT00676897|Primary|Time to Shock Reversal||up to 7 days|||hours||Standard Deviation|Mean
765377|NCT00677014|Secondary|Secondary Endpoints Will Include Structural and Functional Measures||Chronic||||||
765378|NCT00677014|Primary|Left Ventricular End-systolic Volume (LVESV)|Change in square root of absolute left ventricular end systolic volume from baseline to 6 month follow up|6 months|Availability of baseline and 6 month echocardiograms with primary endpoint values (LVESV) among randomized patients||ml||Inter-Quartile Range|Median
765379|NCT00677092|Secondary|Change From Baseline in Short Form 36 (SF-36) Score||Baseline and Month 4|PI left institution in 2009; Data collected cannot be associated with specific participants and analyzed for secondary outcome measure.|||||
765380|NCT00677092|Secondary|Change From Baseline in Health Assessment Questionnaire (HAQ) Score||Baseline and Month 4|PI left institution in 2009; Data collected cannot be associated with specific participants and analyzed for secondary outcome measure.|||||
765381|NCT00677092|Secondary|Change From Baseline in Visual Analog Scale (VAS) for Pain||Baseline and Month 4|PI left institution in 2009; Data collected cannot be associated with specific participants and analyzed for secondary outcome measure.|||||
765382|NCT00677092|Secondary|Change From Baseline in Histologic Appearance of Skin Biopsy||Baseline and Month 4|PI left institution in 2009; Data collected cannot be associated with specific participants and analyzed for secondary outcome measure.|||||
765383|NCT00677092|Secondary|Change From Baseline in Maximal Extension of Elbows and Knees||Baseline and Month 4|PI left institution in 2009; Data collected cannot be associated with specific participants and analyzed for secondary outcome measure.|||||
765384|NCT00677092|Primary|Percentage Change From Baseline in the Modified Rodnan Skin Score (mRSS) to Assess Skin Tethering|The modified Rodnan Skin Score is the accepted clinical measure of scleroderma skin activity. The investigator assessed the thickening of the skin using the modified Rodnan Skin Score through simple palpation on 17 different skin sites in the fingers, hands, forearms, arms, feet, legs, and thighs (bilaterally) and face, chest, and abdomen (singly). Skin thickness was assessed on a scale of 0 to 3; 0 representing normal skin and 3 being severe thickening. The sum of the individual scores can range from 0 (normal) to 51 (severe thickening in all 17 areas). Percentage change is calculated as the Month 4 Score - Baseline Score/Baseline Score * 100. A negative percentage change indicates improvement.|Baseline and Month 4|All enrolled participants with Baseline and Month 4 data available for analysis.||percentage change in mRSS score||Standard Deviation|Mean
765385|NCT00677235|Post-Hoc|Treatment Area Primary Patency (TAPP) at 24 Months.|TAPP is defined as patency (open to blood flow) after the study index procedure until reintervention in the treatment area (within 5mm proximal or 5mm distal to the study device or index balloon angioplasty treated area), or thrombotic occlusion that involved the treatment area.|24 months follow-up|||proportion of participants||95% Confidence Interval|Number
765386|NCT00677235|Post-Hoc|Treatment Area Primary Patency (TAPP) at 12 Months.|TAPP is defined as patency (open to blood flow) after the study index procedure until reintervention in the treatment area (within 5mm proximal or 5mm distal to the study device or index balloon angioplasty treated area), or thrombotic occlusion that involved the treatment area.|12 months follow up|||proportion of participants||95% Confidence Interval|Number
765387|NCT00677235|Secondary|Post-intervention Secondary Patency at 6 Months|Postintervention secondary patency [PSP; referred to as Access Circuit Cumulative Patency (ACCP) in the pivotal trial] was the interval following the treatment procedure until the access circuit was surgically declotted, revised, or abandoned because of inability to treat the original stenosis.|6 month follow-up|||proportion of participants||95% Confidence Interval|Number
765388|NCT00677235|Secondary|Post-Intervention Assisted Primary Patency at 6 Months|Postintervention assisted primary patency (PAPP) was defined as the interval after the index/study procedure until access thrombosis or a surgical intervention that excluded the treated lesion from the access circuit.|6 month follow up|||proportion of participants||95% Confidence Interval|Number
765389|NCT00677235|Secondary|Index of Patency Function (IPF) [the Average Number of Months Between Interventions] Rates of FLAIR™ and PTA at at 24 Months.|The IPF is summarized was defined as the time from the index study procedure to complete graft abandonment divided by the number of visits for a reintervention performed on the AV access circuit in order to maintain vascular access for hemodialysis.|24 months|All patients who were enrolled in the study will participate in the analysis in the treatment group to which they were randomized, regardless of the intervention that they actually incurred (an intent-to-treat analysis).Blackwelder t-test testing non-inferiority of the FLAIR® group to that of PTA.||Months/intervention||Standard Deviation|Least Squares Mean
765390|NCT00677235|Secondary|Post-intervention Secondary Patency at 24 Months|Postintervention secondary patency [PSP; referred to as Access Circuit Cumulative Patency (ACCP) in the pivotal trial] was the interval following the treatment procedure until the access circuit was surgically declotted, revised, or abandoned because of inability to treat the original stenosis.|24 months|||proportion of participants||95% Confidence Interval|Number
765391|NCT00677235|Secondary|Post-Intervention Assisted Primary Patency at 24 Months|Postintervention assisted primary patency (PAPP) was defined as the interval after the index/study procedure until access thrombosis or a surgical intervention that excluded the treated lesion from the access circuit.|24 month follow up|||proportion of participants||95% Confidence Interval|Number
765392|NCT00677235|Secondary|To Estimate Safety at 24 Months.|To estimate the percentage of participants without safety issues through 24 months.|24 months|||percentage of participants|||Number
765393|NCT00677235|Secondary|Access Circuit Primary Patency (ACCP) at 24 Months Procedure Until the Next Access Thrombosis or Reintervention.|Access Circuit Primary Patency (ACPP) was defined as the interval following the index procedure until the next access thrombosis or reintervention at 24 months.|24 months|All patients who were enrolled in the study were included in the analysis in the treatment group to which they were randomized, regardless of the intervention that they actually incurred (an intent-to-treat analysis).||proportion of participants||95% Confidence Interval|Number
765395|NCT00677235|Secondary|Analysis of Proportion of Serious Adverse Events Classified as Device and/or Procedure-Related Through 30 Days Post-Procedure|The incidence of device-related and procedure-related serious adverse events (SAEs) from the index procedure through 30 days post procedure is summarized. The purpose of this analysis was to assess the effectiveness of the Bard Peripheral Vascular (BPV) clinician training program.|Patient Follow-Up|||events|||Number
765396|NCT00677235|Secondary|Procedural Success|Procedural success was a secondary endpoint without hypothesis testing and is therefore summarized descriptively. Procedural success is defined as anatomic success and at least one indicator of hemodynamic or clinical success.|Patient Follow-Up|||Percentage of Participants|||Number
765397|NCT00677235|Secondary|Post-intervention Secondary Patency (PSP) at 12 Months|Postintervention secondary patency [PSP; referred to as Access Circuit Cumulative Patency (ACCP) in the pivotal trial] was the interval following the treatment procedure until the access circuit was surgically declotted, revised, or abandoned because of inability to treat the original stenosis.|12 months|||proportion of participants||95% Confidence Interval|Number
765398|NCT00677235|Secondary|Post-Intervention Assisted Primary Patency at 12 Months|Postintervention assisted primary patency (PAPP) was defined as the interval after the index/study procedure until access thrombosis or a surgical intervention that excluded the treated lesion from the access circuit.|12 months|||proportion of participants||95% Confidence Interval|Number
765399|NCT00677235|Secondary|To Assess the Number of Re-interventions to the Access Circuit Until Graft Abandonment or Through 12 Months Post-index Procedure|The estimated number of re-interventions to the access circuit until graft abandonment or through 12 months post-index procedure was a secondary endpoint without hypothesis testing and is therefore summarized descriptively.|Patient Follow-Up|||reinterventions||Standard Deviation|Mean
765400|NCT00677235|Primary|The Number of Participants With Device and/or Procedure Related Adverse Events at 12 Months Post Study Procedure.||12 months|||Number of Participants with Device and/o|||Number
765401|NCT00677235|Primary|The Index of Patency Function (IPF) [the Average Number of Months Between Interventions] of FLAIR™ is Not Inferior to That of PTA at 12 Months Post Study Procedure.|The IPF is summarized was defined as the time from the index study procedure to complete graft abandonment divided by the number of visits for a reintervention performed on the arteriovenous (AV) access circuit in order to maintain vascular access for hemodialysis.|12 months|All patients who were enrolled in the study will participate in the analysis in the treatment group to which they were randomized, regardless of the intervention that they actually incurred (an intent-to-treat analysis).Blackwelder t-test testing non-inferiority of the FLAIR® group to that of PTA.||Months/intervention||Standard Deviation|Least Squares Mean
765402|NCT00677235|Primary|ACPP Was Defined as the Interval Following the Index Procedure Until the Next Access Thrombosis or Reintervention.|To demonstrate that the post intervention Access Circuit Primary Patency (ACPP) of FLAIR™ is superior to that of PTA at 12 months post study procedure.|12 months|All patients who were enrolled in the study were included in the analysis in the treatment group to which they were randomized, regardless of the intervention that they actually incurred (an intent-to-treat analysis).||proportion of participants||95% Confidence Interval|Number
765403|NCT00677352|Secondary|Percentage of Participants With Deterioration in Antidepressant Discontinuation Scale During Tapering Phase|The percentage of participants divided was calcurated as follows: Devide the number of participants who had experienced new symptoms in Week 16, regardless of causal relationship with the study drug, or worsening of the severity in Week 16 compared with Week 12, by total number of participants in each treatment group.|4 weeks|Completer Set : Subset of patients in the EES who had a PAS rating at Week 16.||Percentage of participants|||Number
765404|NCT00677352|Secondary|Summary of Adverse Events in Tapering Phase|Number of subjects with all causality adverse events, serious adverse events, severe adverse events, adverse events resulted in discontinuation, dose reduced or temporary discontinuation. Subjects were counted only once per treatment in each row.|4 weeks|The safety analysis set : Subset of patients who had taken at least one dose of the study drug and who had visited the study center at least once after taking the study drug.||Participants|||Number
765405|NCT00677352|Secondary|Number of Participants With Summary of Adverse Events in Treatment Phase|Number of sparticipants with all causality adverse events, serious adverse events, severe adverse events, adverse events resulted in discontinuation, dose reduced or temporary discontinuation. Participants were counted only once per treatment in each row.|1, 2, 4, 6, 8 10 and 12 weeks (or study discontinuation) after administration of study drug|The safety analysis set : Subset of patients who had taken at least one dose of the study drug and who had visited the study center at least once after taking the study drug.||Participants|||Number
765406|NCT00677352|Secondary|Mean Change From Baseline in Hamilton Anxiety Rating Scale Total Score at the End of Treatment Phase|"The Hamilton Anxiety Rating Scale provided a 5-point intensity rating (0=None to 4=Very severe) of anxiety symptoms in 14 items.
The increasing values are considered worse outcome. The total possible score is ranged from 0 to 52."|Baseline and 12 weeks|"Efficacy Evaluable Set: A subset of patients in the Full Analysis Set who met some inclusion (diagnosis of Panic Disorder, etc.) and exclusion (psychotherapy, etc.) criteria, had to be treated for a minimum of 8 weeks and had a PAS score at least one evaluation during Week 8 to 12.
Last Observation Carried Forward"||Scores on a scale||Standard Deviation|Mean
765407|NCT00677352|Secondary|Mean Change From Baseline in Panic Attack at the End of Treatment Phase|Panic attacks were defined as having four or more of the following Diagnostic and Statistical Manual of Mental Disorders symptoms. Palpitations or increased heart rate, Sweating, Trembling or shaking, Shortness of breath or smothering sensations, Choking, Chest pain or discomfort, Nausea or upset stomach, Dizziness, unsteady feelings or faintness, Feeling unlike yourself, or detached from a situation and/or like things happening around you are strange and unreal, Fear of going crazy or doing something uncontrolled, Fear of dying, Abnormal sense, Hot flashes or chills.|Baseline and 12 weeks|"Efficacy Evaluable Set: A subset of patients in the Full Analysis Set who met some inclusion (diagnosis of Panic Disorder, etc.) and exclusion (psychotherapy, etc.) criteria, had to be treated for a minimum of 8 weeks and had a PAS score at least one evaluation during Week 8 to 12.
Last Observation Carried Forward"||panic attacks per week||Standard Deviation|Mean
765435|NCT00677820|Secondary|Number of Subjects Reporting All Solicited Symptoms Post-treatment Days 0-7||Days 0-7|Safety population Evaluable for Solicited Symptoms were subjects who received any study vaccine and experienced any follow-up for safety were considered evaluable for safety.||participants|||Number
765408|NCT00677352|Secondary|Percentage of Participants of Responder in Clinical Global Impression (CGI) - Improvement|"The ratings were rated to compare with baseline by 7-point  1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse.
Responder was defined as number of participants who were assessed as very much improved or  much improved."|12 weeks|"Efficacy Evaluable Set: A subset of patients in the Full Analysis Set who met some inclusion (diagnosis of Panic Disorder, etc.) and exclusion (psychotherapy, etc.) criteria, had to be treated for a minimum of 8 weeks and had a PAS score at least one evaluation during Week 8 to 12.
Last Observation Carried Forward"||Percentage of participants|||Number
765409|NCT00677352|Primary|Mean Change From Baseline in Panic and Agoraphobia Scale (PAS) Total Score at the End of Treatment Phase|Panic and Agoraphobia Scale has 13 items with a 5-point scale (range: 0 to 4). The total possible score is ranged from 0 to 52. The increasing value are considered worse outcome. The scale is grouped into 5 subscores (not including item U in total score): panic attacks ; agoraphobia/avoidance behavior ; anticipatory anxiety; disability; and health worries. Four point difference in reduction of the PAS total score has been identified as not clinically meaningful in the assessment of Panic Disorder symptomatology.|Baseline and 12 weeks|"Efficacy Evaluable Set: A subset of patients in the Full Analysis Set who met some inclusion (diagnosis of Panic Disorder, etc.) and exclusion (psychotherapy, etc.) criteria, had to be treated for a minimum of 8 weeks and had a PAS score at least one evaluation during Week 8 to 12.
Last Observation Carried Forward"||Scores on scale||95% Confidence Interval|Least Squares Mean
765410|NCT00677365|Secondary|Changes in Susceptability Patterns of Isolated Organisms|All isolates of P. aeruginosa cultures grown from patient sputum samples were evaluated to see whether the minimum concentration of levofloxacin needed to inhibit growth of the bacteria (i.e., minimum inhibitory concentration; MIC) had increased; 2. The MIC50 and MIC90 values were calculated as the 50th percentile value and the 90th percentile value, respectively. Note that percentile values between dilution values were rounded up to the nearest dilution value|from baseline until the end of the 28-day treatment period (28 days)|MITT||ug/mL|Participants||Number
765411|NCT00677365|Secondary|Changes in Respiratory Domain Scores of Cystic Fibrosis Questionnaire - Revised (CFQ-R)|Change in the score from 0 to 100 that a patient reports for their respiratory symptoms in the CFQ-R. An increase in score illustrates an improvement in symptoms. An increase of 4 or more is considered clinically significant|from baseline to the end of the 28-day treatment period (28 days)|MITT||units on a scale||Standard Error|Least Squares Mean
765412|NCT00677365|Secondary|Change in FEV1 Percent Predicted|Change in the predicted percent of air the patient could exhale in one second|from baseline to the end of the treatment 28-day treatment period (28 days)|MITT||Percent||Standard Error|Least Squares Mean
765413|NCT00677365|Secondary|Percent Change in Forced Expiratory Volume in 1 Second (FEV1)|Percent change in the amount of air the patient could exhale in 1 second|from baseline to end of the 28-day treatment period (28 days)|MITT||Percent change||Standard Error|Least Squares Mean
765414|NCT00677365|Secondary|Time to Administration of Other Anti-pseudomonal Antimicrobials|Time to administration of other anti-pseudomonal antimicrobials in patients with at least one of the following: decreased exercise tolerance, increased cough, increased sputum/chest congestion, or decreased appetite; 25th percentile data reported|from baseline until final study visit (up to 56 days)|MITT||days||95% Confidence Interval|Mean
765415|NCT00677365|Primary|Change in P. Aeruginosa Density|Patients were required to cough deeply and then spit sputum into a sterile container. The bacteria contained in the sputum sample was incubated in a laboratory and the number of P. aeruginosa colony forming units per gram of sputum (CFU/g) was determined. The difference in CFUs/g were then compared from baseline to the conclusion of the 28 day treatment period|from baseline to end of treatment (28 days)|Modified Intent-to-Treat (MITT; patients who received at least one dose of study drug)||log10 CFU/g sputum||Standard Error|Least Squares Mean
765416|NCT00677534|Primary|Change in Monocyte VDR Expression With Vitamin D Therapy|Monocytes will be analyzed pre- and post-cholecalciferol by flow cytometry to measure changes in monocyte VDR expression. Unit of measure is represented by mean florescence intensity (MFI), which is a relative measure.|Change from End of Washout to Week 12|Clinical pilot trial - proof of concept||units on a scale||Standard Deviation|Mean
765417|NCT00677690|Secondary|Respiratory Function|forced expiratory volume in 1 second (FEV1)|5 weeks|||percentage of predicted value||Standard Deviation|Mean
765418|NCT00677690|Primary|Quadriceps Strength|Quadriceps strength was assessed by means of Sit to Stand Test (STST). The subjects held their arms stationary by putting their hands on their hips. The subjects were asked to complete the sitting and standing positions without using the arms for support while rising and sitting. Once instructed, subjects stand upright and without delay sit down again, repeating the procedure as many times as possible in a 1 min period. The number of completed repetitions was recorded. The subjects were permitted to use rest periods to complete 1 min.|5 weeks|||repetitions||Standard Deviation|Mean
765419|NCT00677690|Secondary|Quality of Life|St. George's respiratory questionnaire is a standardized self-administered airways disease-specific questionnaire divided into three subscales: symptoms (eight items), activity (16 items), and impacts (26 items). For each subscale and for the overall questionnaire, scores range from zero (no impairment) to 100 (maximum impairment).|5 weeks|||units on a scale||Standard Deviation|Mean
765420|NCT00677690|Primary|Exercise Capacity|6 minute walk test(6MWT)|5 weeks|||meters||Standard Deviation|Mean
765421|NCT00677690|Secondary|Dyspnoea|The modified Medical Research Council (MMRC) scale was used for rating dyspnoea. MMRC is a five-point scale based on degrees of various physical activities that precipitate breathlessness. Scores on the MMRC dyspnoea scale can range from 0 (normal) to 4.|5 weeks|||units on a scale||Standard Deviation|Mean
765431|NCT00677820|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs) and Significant New Medical Conditions (SNMC)|"SAEs were those that resulted in death; were life-threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly/birth defect in the offspring of a study participant; or were an medical event that may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above.
An SNMC was a newly diagnosed medical condition of a chronic, ongoing nature and assessed by the investigator as medically significant."|Days 0-28|Subjects who received any study vaccine and experienced any follow-up for safety were considered evaluable for safety.||participants|||Number
765422|NCT00677807|Secondary|Quality of Life Assessment With St George's Respiratory Questionnaire (SGRQ) Total Score at Weeks 36, 44 and 52|"The least squares mean of the SGRQ total score at weeks 36, 44 and 52. Mixed model used for analysis used baseline SGRQ total score as well as FEV1 reversibility components as covariates.
SGRQ is a health related quality of life questionnaire consisting of 50 items in three domains: symptoms, activity and impacts. The total score is 0 to 100 with a higher score indicating poorer health. A difference from placebo of -4 in the least squares mean SGRQ total score is considered clinically relevant."|Weeks 36, 44 and 52|"Extension Intent-to-treat population consisting of all participants who received at least one dose of study drug. n in each of the categories is the number of participants with data at the given time point. Missing data were imputed using LOCF but not by more than 14 weeks and not by carrying forward scores within 4 weeks of treatment start."||Score on a Scale||Standard Error|Least Squares Mean
765423|NCT00677807|Primary|Blood Glucose (mmol/L) 1 Hour Post Dose at Weeks 12, 26, 36, 44 and 52|The least squares mean of the blood glucose in mmol/L at weeks 12, 26, 36, 44 and 52. Mixed model used baseline blood glucose as a covariate.|Weeks 12, 26, 36, 44 and 52|"Extension safety population consisting of all participants who received at least one dose of study drug in the extension study. n in the categories is the number of participants with data at the given time point for each treatment."||mmol/L||Standard Error|Least Squares Mean
765424|NCT00677807|Primary|Serum Potassium (mmol/L) 1 Hour Post-dose at Weeks 12, 26, 36, 44 and 52|The least squares mean of the serum potassium in mmol/L at weeks 12, 26, 36, 44 and 52. Mixed model used baseline serum potassium as a covariate.|Weeks 12, 26, 36, 44 and 52|"Extension safety population consisting of all participants who received at least one dose of study drug in the extension study. n in the categories is the number of participants with data at the given time point for each treatment."||mmol/L||Standard Error|Least Squares Mean
765425|NCT00677807|Primary|The Number of Participants With a Clinically Notable QTc Interval Value During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo|"The number of participants with newly occurring or worsening clinically notable QTc Interval value at anytime post baseline.
The QTc interval is calculated using Fridericia's formula: QTc= QT/cube root RR. QTc is the interval between the Q and T waves corrected for heart rate and RR is the interval between two R waves in milliseconds (ms).
Notable QTC interval= >450 ms for males and >470 ms for females. The maximum QTC increase from pre to post dose at any time during the study was also tabulated with absolute and relative frequencies for categories 30- 60 ms and >60 ms."|Up to 52 weeks|Extension safety population consisting of all participants who received at least one dose of study drug in the extension study.||participant|||Number
765426|NCT00677807|Primary|The Number of Participants With a Clinically Notable Diastolic Blood Pressure During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo|"The number of participants with newly occurring or worsening clinically notable vital sign: Diastolic Blood Pressure (mmHg) at anytime post baseline (BL) by treatment.
A Low Diastolic Blood Pressure was defined as a diastolic blood pressure measurement: <40 mmHg or <= to 50 mmHg and a decrease from baseline >= to 15 mmHg.
A High Diastolic Blood Pressure was defined as a diastolic blood pressure measurement: >115 mmHg or >= to 105 mmHg and an increase from baseline >= to 15 mmHg."|Up to 52 weeks|Extension safety population consisting of all participants who received at least one dose of study drug in the extension study.||participants|||Number
765427|NCT00677807|Primary|The Number of Participants With a Clinically Notable Systolic Blood Pressure During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo|"The number of participants with newly occurring or worsening clinically notable vital sign: Systolic Blood Pressure (mmHg) at anytime post baseline (BL) by treatment.
A Low Systolic Blood Pressure was defined as a systolic blood pressure measurement: <75 mmHg or <= to 90 mmHg and a decrease from baseline >= to 20 mmHg.
A High Systolic Blood Pressure was defined as a systolic blood pressure measurement: >200 mmHg or >= to 180 mmHg and an increase from baseline >= to 20 mmHg."|Up to 52 weeks|Extension safety population consisting of all participants who received at least one dose of study drug in the extension study.||participants|||Number
765428|NCT00677807|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 52 of Treatment|Spirometry was conducted according to internationally accepted standards. The trough FEV1 was defined as the average of the FEV1 measurements taken at 23 hours 10 minutes and 23 hours 45 minutes post dose at week 52. The mixed model used baseline FEV1 as well as FEV1 reversibility components as covariates.|Week 52|Participants from the Extension Intent-to-treat population (consisting of all participants who received at least one dose of study drug) for whom data was available for this Outcome Measure. Missing data was imputed Last Observation Carried Forward.||Liters||Standard Error|Least Squares Mean
765429|NCT00677807|Primary|The Number of Participants With a Clinically Notable Pulse Rate During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo|"The number of participants with newly occurring or worsening clinically notable vital sign: Pulse Rate in beats per minute (bpm) at anytime post baseline (BL) by treatment.
Low Pulse Rate was defined as a pulse rate: <40 bpm or <= to 50 bpm and a decrease from baseline >= to 15 bpm.
High Pulse Rate was defined as a pulse rate: >130 bpm or >= to 120 bpm and an increase from baseline >= to 15 bpm."|Up to 52 weeks|Extension safety population consisting of all participants who received at least one dose of study drug in the extension study.||Participants|||Number
765430|NCT00677820|Secondary|Number of Subjects Reporting SAEs and SNMCs|"SAEs were those that resulted in death; were life-threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly/birth defect in the offspring of a study participant; or were an medical event that may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above.
An SNMC was a newly diagnosed medical condition of a chronic, ongoing nature and assessed by the investigator as medically significant."|Days 0-180|Subjects who received any study vaccine and experienced any follow-up for safety were considered evaluable for safety.||participants|||Number
765432|NCT00677820|Secondary|Number of Subjects Reporting Any AEs Post Treatment||Days 0-14|Subjects who received any study vaccine and experienced any follow-up for safety were considered evaluable for safety.||participants|||Number
765433|NCT00677820|Secondary|Number of Subjects Reporting All Solicited Symptoms Post-treatment Days 0-14||Days 0-14|Safety population Evaluable for Solicited Symptoms were subjects who received any study vaccine and experienced any follow-up for safety were considered evaluable for safety.||participants|||Number
765436|NCT00677820|Primary|Number of Subjects Reporting Fever|Fever was defined as oral temperature greater than or equal to 101 degrees Fahrenheit.|Days 0-7|Safety population Evaluable for Solicited Symptoms were subjects who received any study vaccine and experienced any follow-up for safety were considered evaluable for safety.||participants|||Number
765437|NCT00677833|Secondary|Percentage of Participants With PfCRT in True Failures|A genetic marker, P.falciparum chloroquine resistance transporter (PfCRT), indicative of P.falciparum chloroquine resistance was to be determined from blood blots obtained on Day 0 and at the time of treatment failure. Treatment failure was defined as any of the following events that a participant experienced from Day 0 through the Day 42 visit: ETF (see measure description in secondary outcome measures 7 and 8), LCF (PCR corrected) (see measure description in secondary outcome measure 9 and 10), or LPF (PCR corrected) (see measure description in secondary outcome measure 11 and 12). Recrudescence of asexual P.falciparum parasites was considered treatment failure.|Baseline to Day 42|Data for this outcome measure was not analyzed as per change in planned analysis.|||||
765438|NCT00677833|Secondary|Number of Participants With Recurrent Parasitemia Versus Baseline Plasmodium Falciparum Chloroquine Resistance Transporter (PfCRT) Status||Baseline to Day 42|Data for this outcome measure was not analyzed as per change in planned analysis.|||||
765439|NCT00677833|Secondary|Time to Recurrence of Parasitemia|Time from the day of clearance to the time of recurrence of asexual P.falciparum parasitemia (PCR-uncorrected).|Baseline (Day 0) to Day 42|mITT population, including participants in the Ivory Coast center.||Days||Full Range|Median
765440|NCT00677833|Secondary|Change From Nadir Hemoglobin Level at Days 14, 28, and 42|Change from nadir = observation minus nadir. Nadir defined as the minimum value for each participant on Days 0-3.|Day 14, 28, 42|"mITT population. N = number of participants with evaluable data, including participants in the Ivory Coast center. n=participants who were evaluable at specified time points for each arm, respectively."||g/dL||Standard Error|Mean
765441|NCT00677833|Secondary|Nadir Hemoglobin Level|Nadir hemoglobin for each participant was defined as the minimum hemoglobin values obtained from Day 0 through Day 3.|Day 0 through Day 3|mITT population, including participants in the Ivory Coast center.||grams per deciliter (g/dL)||Standard Deviation|Mean
765442|NCT00677833|Secondary|Asexual Plasmodium Falciparum Parasite Clearance Time|Defined as time to first of two consecutive zero asexual P. falciparum parasite (PCR-corrected) counts, regardless of recurrence of parasitemia later. PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.|Baseline to Day 42|mITT population, including participants in the Ivory Coast center.||Hours||Full Range|Median
765443|NCT00677833|Secondary|Fever Clearance Time|Calculated as time of first occurrence of two consecutive time points with temperature less than (<) 38.0 degrees C/100.4 degrees Fahrenheit (F) (rectal), 37.2 degrees C/99.0 degrees F (axillary), or <37.5 degrees C/99.5 degrees F (oral).|Baseline to Day 42|mITT population, including participants in the Ivory Coast center.||Hours||Full Range|Median
765444|NCT00677833|Secondary|Percentage of Participants With Gametocytologic Response|Gametocyte response/absence/clearance: Clearance of P.falciparum gametocytemia (PCR-uncorrected) (attainment of 2 consecutive zero gametocyte counts) without subsequent recurrence through the day of consideration. PCR-uncorrected: not adjusted for molecular testing which determined recrudescence or true failures from reinfection.|Days 7, 14, 21, 28, 35, 42|"mITT population. N= participants with evaluable data, including participants in the Ivory Coast center. n=participants who were evaluable at specified time points for each arm, respectively."||Percentage of participants|||Number
765445|NCT00677833|Secondary|Percentage of Participants With Asexual Parasitologic Response (PCR-corrected)|Percentage of participants who were cleared of asexual parasites. Asexual parasite clearance - clearance of asexual P.falciparum parasitemia within 7 days of initiation of treatment without subsequent recurrence (PCR-corrected) through the day of consideration. PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.|Day 7, 14, 21, 28, 35, 42|"mITT population. Number of participants analyzed (N)=participants with evaluable data, including participants in the Ivory Coast center. n=participants who were evaluable at specified time points for each arm, respectively."||Percentage of participants|||Number
765446|NCT00677833|Secondary|Percentage of Participants With LPF in PP Population (PCR-corrected)|LPF: Presence of P.falciparum parasitemia in the PP population on any day from Day 7 onward and the absence of fever without previously meeting any of the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or LCF (see measure description in secondary outcome measure 9 and 10). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.|Days 7, 14, 21, 28, 35, 42|PP population, participants in Ivory Coast center were excluded from the PP population.||Percentage of participants|||Number
765447|NCT00677833|Secondary|Percentage of Participants With Late Parasitologic Failure (LPF) in the mITT Population (PCR-corrected)|LPF: Presence of P. falciparum parasitemia in the mITT population on any day from Day 7 onward and the absence of fever without previously meeting any of the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or LCF (see measure description in secondary outcome measure 9 and 10). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.|Days 7, 14, 21, 28, 35, 42|mITT population, participants in Ivory Coast center were excluded from mITT population.||Percentage of participants|||Number
765448|NCT00677833|Secondary|Percentage of Participants With LCF in PP Population (PCR-corrected)|"LCF included participants who met any of the following criteria:
Development of signs of severe malaria or clinical deterioration requiring rescue medication after Day 3 in the presence of P.falciparum parasitemia, without previously meeting any of the criteria of ETF (see measure description in secondary outcome measures 7 and 8)
Presence of P.falciparum parasitemia and fever on any day from Day 4 onward, without previously meeting any of the criteria of ETF (see measure description in secondary outcome measures 7 and 8). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation."|Days 7, 14, 21, 28, 35, 42|PP population, participants in Ivory Coast center were excluded from the PP population.||Percentage of participants|||Number
765449|NCT00677833|Secondary|Percentage of Participants With Late Clinical Failure (LCF) in the mITT Population (PCR-corrected)|"LCF included participants who met any of the following criteria:
Development of signs of severe malaria or clinical deterioration requiring rescue medication after Day 3 in the presence of P.falciparum parasitemia, without previously meeting any of the criteria of ETF (see measure description in secondary outcome measures 7 and 8)
Presence of P.falciparum parasitemia and fever on any day from Day 4 onward, without previously meeting any of the criteria of ETF (see measure description in secondary outcome measures 7 and 8). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation."|Days 7, 14, 21, 28, 35, 42|mITT population, participants in Ivory Coast center were excluded from mITT population.||Percentage of participants|||Number
765450|NCT00677833|Secondary|Percentage of Participants With ETF in PP Population (PCR-corrected)|"ETF defined as participants who met the following criteria:
Developed signs of severe malaria or clinical deterioration that required rescue medication on Days 0, 1, 2 or 3, in the presence of P.falciparum parasitemia
Last available asexual P.falciparum parasite count on Day 2 greater than the first available parasite count on Day 0 (Baseline), irrespective of axillary, oral or rectal temperature.
Parasitemia (P.falciparum) on Day 3 with fever or
Last available P.falciparum parasite count on Day 3 >=25% of the first available parasite count on Day 0 (Baseline).
PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation."|Day 0 up to Day 3|PP population, participants in Ivory Coast center were excluded from the PP population.||Percentage of participants|||Number
765451|NCT00677833|Secondary|Percentage of Participants With Early Treatment Failure (ETF) in the mITT Population (PCR-corrected)|"ETF defined as participants who met the following criteria:
Developed signs of severe malaria or clinical deterioration that required rescue medication on Days 0, 1, 2 or 3, in the presence of P. falciparum parasitemia
Last available asexual P. falciparum parasite count on Day 2 greater than the first available parasite count on Day 0 (Baseline), irrespective of axillary, oral or rectal temperature.
Parasitemia (P. falciparum) on Day 3 with fever or
Last available P. falciparum parasite count on Day 3 >=25% of the first available parasite count on Day 0 (Baseline).
PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation."|Day 0 up to Day 3|mITT population, participants in Ivory Coast center were excluded from mITT population.||Percentage of participants|||Number
765452|NCT00677833|Secondary|Percentage of Participants With PCR-uncorrected ACPR in PP Population|ACPR (PCR-uncorrected) was defined as asexual P.falciparum parasitologic clearance on Days 7, 14, 21, 28, 35, 42 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or PCR-uncorrected LTF (which includes PCR-uncorrected LCF - see measure description in secondary outcome measure 9 and 10, and PCR-uncorrected LPF – see measure description in secondary outcome measure 11 and 12). PCR-uncorrected: not adjusted for molecular testing which determined recrudescence or true failures from reinfection.|Days 7, 14, 21, 28, 35, 42|PP population. For ACPR efficacy endpoints, participants in Ivory Coast center were excluded from the PP population.||Percentage of participants||95% Confidence Interval|Number
765453|NCT00677833|Secondary|Percentage of Participants With PCR-uncorrected ACPR in the mITT Population|ACPR (PCR-uncorrected) was defined as asexual P.falciparum parasitologic clearance on Days 7, 14, 21, 28, 35, 42 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or PCR-uncorrected LTF (which includes PCR-uncorrected LCF - see measure description in secondary outcome measure 9 and 10, and PCR-uncorrected LPF – see measure description in secondary outcome measure 11 and 12). PCR-uncorrected: not adjusted for molecular testing which determined recrudescence or true failures from reinfection.|Days 7, 14, 21, 28, 35, 42|mITT population. For ACPR efficacy endpoints, participants in Ivory Coast center were excluded from mITT population.||Percentage of participants||95% Confidence Interval|Number
765454|NCT00677833|Secondary|Percentage of Participants With PCR-corrected ACPR in PP Population|ACPR (PCR-corrected) was defined as asexual P.falciparum parasitologic clearance on Days 7, 14, 21, 35, 42 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or PCR-corrected LTF (which includes PCR-corrected LCF - see measure description in secondary outcome measure 9 and 10, and PCR-corrected LPF – see measure description in secondary outcome measure 11 and 12). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.|Days 7, 14, 21, 35, 42|PP population. For ACPR efficacy endpoints, participants in Ivory Coast center were excluded from the PP population.||Percentage of participants||95% Confidence Interval|Number
765455|NCT00677833|Secondary|Percentage of Participants With PCR-corrected ACPR in the mITT Population|ACPR (PCR-corrected) was defined as asexual P.falciparum parasitologic clearance on Days 7, 14, 21, 35, 42 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or PCR-corrected LTF (which includes PCR-Corrected LCF- see measure description in secondary outcome measure 9 and 10, and PCR-corrected LPF – see measure description in secondary outcome measure 11 and 12). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.|Days 7, 14, 21, 35, 42|mITT population. For ACPR efficacy endpoints, participants in Ivory Coast center excluded from mITT population.||Percentage of participants||95% Confidence Interval|Number
765456|NCT00677833|Primary|Percentage of Participants With PCR-corrected ACPR at Day 28 in Per-Protocol (PP) Population|ACPR (PCR-corrected) was defined as asexual P.falciparum parasitologic clearance at Day 28 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or PCR-corrected LTF (which includes PCR-corrected LCF - see measure description in secondary outcome measure 9 and 10, and PCR-corrected LPF – see measure description in secondary outcome measure 11 and 12). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.|Day 28|Per-Protocol (PP) population was a subset of the mITT population, who received all 3 days of study medication to which they were assigned. For ACPR efficacy endpoints, participants in Ivory Coast center excluded from PP population.||Percentage of participants||95% Confidence Interval|Number
765457|NCT00677833|Primary|Percentage of Participants With Polymerase Chain Reaction (PCR)-Corrected Adequate Clinical and Parasitologic Response (ACPR) at Day 28 in the Modified Intent-to-treat (mITT) Population|ACPR (PCR-corrected) was defined as asexual Plasmodium falciparum (P.falciparum) parasitologic clearance at Day 28 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of Early Treatment Failure (ETF) (see measure description in secondary outcome measures 7 and 8) or PCR-corrected Late Treatment Failure (LTF) (which includes PCR-corrected Late Clinical Failures [LCF] - see measure description in secondary outcome measure 9 and 10, and PCR-corrected Late Parasitologic Failures (LPF)– see measure description in secondary outcome measure 11 and 12). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.|Day 28|mITT:treated participants who met disease criteria(blood smears positive for P.falciparum monoinfection;asexual parasitemia=1000-100,000 parasites/microliter [mcL];fever/history of fever >=38 degree Celsius[C] [rectal],37.2 degree C [axillary] or >=37.5 degree C [oral] within last 24 hours).Participants in Ivory Coast center excluded from analysis.||Percentage of participants||95% Confidence Interval|Number
765458|NCT00677898|Primary|Percentage of Days in the Study Period That a Patient's Screening for Metabolic Side Effects of Second-generation Antipsychotic Medications Adheres to Guidelines: Triglycerides|Guidelines recommend that triglycerides be evaluated every 2 years|1 year|||percentage of days in the study period||Standard Deviation|Mean
765459|NCT00677898|Primary|Percentage of Days in the Study Period That a Patient's Screening for Metabolic Side Effects of Second-generation Antipsychotic Medications Adheres to Guidelines: HDL Cholesterol|Guidelines recommend that HDL cholesterol be evaluated every 2 years|1 year|||percentage of days in study period||Standard Deviation|Mean
765460|NCT00677898|Primary|Percentage of Days in the Study Period That a Patient's Screening for Metabolic Side Effects of Second-generation Antipsychotic Medications Adheres to Guidelines: LDL Cholesterol|Guidelines recommend that LDL cholesterol be evaluated every 2 years|1 year|||percentage of days in study period||Standard Deviation|Mean
765461|NCT00677898|Primary|Percentage of Days in the Study Period That a Patient's Screening for Metabolic Side Effects of Second-generation Antipsychotic Medications Adheres to Guidelines: Blood Glucose/HbA1c|Guidelines recommend that blood glucose/HbA1c be evaluated every year|1 year|||percentage of days in the study period||Standard Deviation|Mean
765462|NCT00677898|Primary|Percentage of Days in the Study Period That a Patient's Screening for Metabolic Side Effects of Second-generation Antipsychotic Medications Adheres to Guidelines: Blood Pressure|Guidelines recommend that blood pressure be evaluated every 3 months|1 year|||percentage of days in the study period||Standard Deviation|Mean
765463|NCT00677898|Primary|Percentage of Days in the Study Period That a Patient's Screening for Metabolic Side Effects of Second-generation Antipsychotic Medications Adheres to Guidelines: Body Mass Index|Guidelines recommend that body mass index be evaluated every 3 months|1 year|||percentage of days in the study period||Standard Deviation|Mean
765464|NCT00677924|Secondary|Best Overall Response|Best overall response according to RECIST criteria J Natl Cancer Inst 2000;92:205-16|Overall Study|||Participants|||Number
765465|NCT00677924|Primary|Adverse Events|Number of patients experiencing an adverse event|Overall Study|Number of patients experiencing an adverse event||participants|||Number
765466|NCT00678015|Post-Hoc|Disease Progression at End of Study|End-of-study imaging was assessed for disease progression per Response Evaluation Criteria In Solid Tumors (RECIST) criteria: * Progressive Disease (PD)=At least a 20% increase in the sum of the largest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Baseline, End of treatment (2-19 cycles)|At the time of calculation, 1 patient was still on study after 29 cycles||participants|||Number
765467|NCT00678015|Post-Hoc|Change in Prostate Specific Antigen Doubling Time (PSADT)|PSADT was calculated using the formula natural log 2 divided by the slope of the natural log of the PSA versus time. Pretreatment PSADT was calculated using a minimum of 3 values; end of study PSADT incorporated all measured PSA values on study starting Cycle 2-Day 1 until the patient was removed from the study.|Cycle 2 through end of treatment (up to 29 months)|At the time of PSADT calculations, one participant was still on study at 29 months, and 11 participants' time on study had ranged from 2-19 months||percentage change||Full Range|Median
765468|NCT00678015|Post-Hoc|PSA Decline|Number of participants experiencing PSA decline during the first 3 treatment cycles|Baseline; Monthly, up to 29 months after beginning treatment|||participants|||Number
765469|NCT00678015|Primary|Prostate Specific Antigen (PSA) Response According to Consensus Criteria|Participants who experienced a PSA decline of at least 50%, confirmed by a second PSA value 4 or more weeks later. The reference PSA for decline was a PSA measured within 2 weeks of beginning study treatment. If at most 1 PSA response was observed among the first 12 patients, then accrual would stop and the trial would close for futility.|Monthly, up to 29 months|||participants|||Number
765470|NCT00678041|Secondary|Frequency of Adverse Events Related to Daily Nitrofurantoin Exposure Such as Nausea, Diarrhea, C. Difficile Colitis|0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.|6 weeks after surgery|0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.|||||
765471|NCT00678041|Secondary|Frequency of Adverse Events Related to CISC Such as Urethral Pain, Irritative Voiding Symptoms, Hematuria|0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.|6 weeks after surgery|0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.|||||
765472|NCT00678041|Secondary|Patient Perceptions Regarding CISC|0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.|6 weeks after surgery||||||
765473|NCT00678041|Secondary|Adherence to CISC|0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.|6 weeks after surgery|0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.|||||
765474|NCT00678041|Secondary|Frequency of Urine Cultures Positive for Organism Strains That Are Resistant to Nitrofurantoin and Other Commonly Used Antibiotics.|0 participants analyzed due to study termination.Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.|6 weeks after surgery|0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.|||||
765475|NCT00678041|Secondary|Time (Days After Surgery) to Development of Symptomatic, Culture Documented UTI|0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.|6 weeks after surgery|0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.|||||
765476|NCT00678041|Primary|Frequency of Symptomatic UTI's Confirmed With a Positive Urine Culture Within 6 to 8 Weeks After CISC Teaching and Implementation|Participants are to be assessed for UTI systems and f/u urine culture routine over a period of 6 to 8 weeks after CISC teaching and implementation.|6 to 8 weeks after surgery|0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.|||||
765477|NCT00678210|Secondary|Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%) - 6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).|Baseline, Week 2, 4, 8, 12, 14, 16|FAS included all participants who received at least 1 dose of investigational drug and had at least 1 valid post-baseline efficacy assessment. No imputation was done. n=participants evaluable for this measure at specified time points for each arm group respectively.||units on a scale||Standard Error|Mean
765478|NCT00678210|Secondary|Psoriasis Area and Severity Index (PASI) Component Scores and Total Score|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).|Baseline, Week 2, 4, 8, 12, 14, 16|FAS included all participants who received at least 1 dose of investigational drug and had at least 1 valid post-baseline efficacy assessment. No imputation was done. n=participants evaluable for this measure at specified time points for each arm group respectively.||units on a scale||Standard Error|Mean
765479|NCT00678210|Secondary|Percentage of Participants Achieving a 90% Improvement in Psoriasis Area and Severity Index (PASI 90) Score|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).|Week 12|FAS included all participants who received at least 1 dose of investigational drug and had at least 1 valid post-baseline efficacy assessment. Missing values imputed using LOCF.||percentage of participants|||Number
765480|NCT00678210|Secondary|Percentage of Participants Achieving a 50% Improvement in Psoriasis Area and Severity Index (PASI 50) Score|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%) - 6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).|Week 2, 4, 8, 12, 14, 16|FAS included all participants who received at least 1 dose of investigational drug and had at least 1 valid post-baseline efficacy assessment. Missing values imputed using LOCF for week 2, 4, 8, 12 and no imputation done for week 14, 16. n=participants evaluable for this measure at specified time points for each arm group respectively.||percentage of participants|||Number
765481|NCT00678210|Secondary|Percentage of Participants Achieving a 75% Improvement in Psoriasis Area and Severity Index (PASI 75) Score|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%) - 6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).|Week 2, 4, 8, 14, 16|FAS included all participants who received at least 1 dose of investigational drug and had at least 1 valid post-baseline efficacy assessment. Missing values imputed using LOCF for week 2, 4, 8 and no imputation done for week 14, 16. n=participants evaluable for this measure at specified time points for each arm group respectively.||percentage of participants|||Number
765494|NCT00678288|Secondary|Duration of Response|Duration of Response was the time from date of first response (Complete Response [CR] or Partial Response [PR]) to the date when Progressive Disease (PD) is first documented or to the date of death, whichever occurs first. Subjects still having CR or PR at the time of analysis were censored at their last date of last contact.|From start of treatment of the first subject until 14 months later, assessed every 8 Weeks|Efficacy analysis was not performed due to low accrual. For details, please see Limitation and Caveats.|||||
769127|NCT00709124|Secondary|Overall Body Strength: 6 Bilateral Muscle Groups in Arms and Legs (MRC Composite Score) Between Those Who Receive NMES vs. Sham Sessions||ICU and hospital discharge||||||
765482|NCT00678210|Secondary|Percentage of Participants Achieving Physician’s Global Assessment (PGA) Score of “Clear” or “Almost Clear”|Physician global assessment of psoriasis is global consideration of the erythema, induration and scaling across all psoriatic lesions, rated separately over the whole body according to a 5-point severity scale ranged from 0 to 4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. The severity scores are summed and averaged after which the total average is rounded to the nearest whole number score to determine the treatment area overall severity of psoriasis score and category. The score of 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe.|Week 2, 4, 8, 12, 14, 16|FAS included all participants who received at least 1 dose of investigational drug and had at least 1 valid post-baseline efficacy assessment. Missing values imputed using LOCF for week 2, 4, 8, 12 and no imputation done for week 14, 16. n=participants evaluable for this measure at specified time points for each arm group respectively.||percentage of participants|||Number
765483|NCT00678210|Primary|Percentage of Participants Achieving a 75% Improvement in Psoriasis Area and Severity Index (PASI 75) Score at Week 12|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%) - 6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).|Week 12|Full analysis set (FAS) included all randomized participants who received at least 1 dose of investigational drug and had at least 1 valid post-baseline efficacy assessment. Missing values were imputed using last observation carried forward (LOCF).||percentage of participants|||Number
765484|NCT00678249|Secondary|Percent of Participants With Binary Restenosis|Binary restenosis defined as lesions with greater than or equal to 50% diameter stenosis of the treatment area (calculated by a core lab).|6 month Follow-Up|If a participant was lost to follow-up prior to the follow-up interval window (or the core lab could not assess the angiogram), then the participant's status was considered missing for that time point and was not included in the ITT analysis.||Percentage of Participants|||Number
765485|NCT00678249|Secondary|Percent of Participants With Access Circuit Cumulative Patency (ACCP or Secondary Patency)|ACCP defined as patency (open to blood flow) following the index study procedure until the access is surgically revised or abandoned because of the inability to treat the original lesion. Multiple treatments for occlusions to restore patency are compatible with ACCP.|6 month Follow-Up|If a participant was lost to follow-up prior to the follow-up interval window, then the participant's status was considered missing for that time point and was not included in the ITT analysis.||Percentage of Participants|||Number
765486|NCT00678249|Secondary|Percent of Participants With Access Circuit Assisted Primary Patency (ACAPP)|ACAPP defined as patency (open to blood flow)following the index study procedure until access thrombosis or a surgical intervention that excludes the treated lesion from the access circuit.|6 month Follow-Up|If a participant was lost to follow-up prior to the follow-up interval window, then the participant's status was considered missing for that time point and was not included in the ITT analysis.||Percentage of Participants|||Number
765487|NCT00678249|Secondary|Percent of Participants With Access Circuit Primary Patency (ACPP)|ACCP defined as patency (open to blood flow) following the index study procedure until access thrombosis or an intervention of a lesion anywhere within the access circuit.|6 month Follow-Up|If a participant was lost to follow-up prior to the follow-up interval window, then the participant's status was considered missing for that time point and was not included in the ITT analysis.||Percentage of Participants|||Number
765488|NCT00678249|Secondary|Percent of Participants With TAPP|TAPP was defined as patency (open to blood flow) after the study index procedure until reintervention in the treatment area (within 5 mm proximal or 5 mm distal to the study device or index balloon angioplasty treatment area), or thrombotic occlusion that involved the treatment area.|2 month Follow-Up|If a participant was lost to follow-up prior to the follow-up interval window, then the participant's status was considered missing for that time point and was not included in the ITT analysis.||Percentage of Participants|||Number
765489|NCT00678249|Secondary|Percent of Participants With Procedural Success|Procedural Success was defined as anatomic success (<30% residual stenosis) and at least one indicator of hemodynamic or clinical success|Index Procedure|||Percentage of Participants|||Number
765490|NCT00678249|Secondary|Percent of Participants With Successful Delivery of the Device|The ability to successfully deliver the FLAIR™ Endovascular Stent Graft. Successful delivery is the ability to deliver and seat the implant in the intended location of a stenosed segment of the venous anastomosis region of a synthetic access graft. This attribute is only applicable to the FLAIR and FLAIR Roll-in arms.|Index Procedure|The PTA Only group was not analyzed for this outcome measure because it is for successful delivery of the FLAIR study device (PTA Only is the control arm).||Percentage of Participants|||Number
765491|NCT00678249|Secondary|Total Number of Adverse Events|The safety endpoint was evaluated based on the incidence of adverse events observed within the same time interval. An adverse event was defined as any undesirable clinical occurrence in a patient that (a) is considered possibly or definietly device related by the investigator, (b) involves the access circuit (AV graft arterial anastomosis to the superior vena cava-right atrial junction) or the arm where the access circuit is located or (c) the investigator considers relevant to the objectives of this study. An adverse event could be mild, moderate or severe.|6 month Follow-Up|||total events|||Number
765492|NCT00678249|Primary|Percent of Participants With Treatment Area Primary Patency (TAPP)|TAPP was defined as patency (open to blood flow) after the study index procedure until reintervention in the treatment area (within 5 mm proximal or 5 mm distal to the study device or index balloon angioplasty treatment area), or thrombotic occlusion that involved the treatment area.|6 month follow-up|If a participant was lost to follow-up prior to the follow-up interval window, then the participant's status was considered missing for that time point and was not included in the ITT analysis.||Percentage of Participants|||Number
765493|NCT00678288|Secondary|Overall Survival|Overall Survival was the time from treatment start date to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.|From start of treatment of the first subject until 14 months later, assessed every 8 Weeks|Efficacy analysis was not performed due to low accrual. For details, please see Limitation and Caveats.|||||
765495|NCT00678288|Secondary|Time to Progression|Time to progression was the time from treatment start date to disease progression. Subjects without progression at the time of analysis were censored at their last date of tumor evaluation.|From start of treatment of the first subject until 14 months later, assessed every 8 Weeks|Efficacy analysis was not performed due to low accrual. For details, please see Limitation and Caveats.|||||
765496|NCT00678288|Secondary|Response Rate|Response Rate was the best tumor response (confirmed Complete Response [CR], Partial Response [PR] or Stable Disease [SD]) observed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.|From start of treatment of the first subject until 14 months later, assessed every 8 Weeks|Efficacy analysis was not performed due to low accrual. For details, please see Limitation and Caveats.|||||
765497|NCT00678288|Primary|Progression-Free Survival|Progression-free Survival (PFS) was the time from the first dose of combination therapy to disease progression (radiological or clinical, whichever is earlier, according to Response Evaluation Criteria in Solid Tumors [RECIST]) or death (if death occurs before progression is documented). PFS for subjects without tumor progression or death at the time of analysis were censored at the date of last tumor evaluation.|From start of treatment of the first subject until 14 months later, assessed every 8 weeks|Efficacy analysis was not performed due to low accrual. For details, please see Limitation and Caveats.|||||
765498|NCT00678379|Secondary|Number and Percent of Participants Able to Tolerate a Regular Diet|The number and percent of patients whose post-operative diet has to a regular diet on post-operative days 1, 3, 5 & 7|post-operative days 1,3,5 & 7.|||Participants|||Count of Participants
765499|NCT00678379|Secondary|Number and Percent of Participants Able to Tolerate Only a Soft Diet|The number and percent of patients whose post-operative diet has only advanced to a soft diet on post-operative days 1, 3, 5 & 7|post-operative days 1,3,5 & 7.|per group diet||Participants|||Count of Participants
765500|NCT00678379|Secondary|Number and Percent of Participants Able to Tolerate Only Liquids|The number and percent of patients whose post-operative diet has advanced to liquids only on post-op days 1, 3, 5 & 7|post-operative days 1,3,5 & 7.|per group data||Participants|||Count of Participants
765501|NCT00678379|Secondary|Mean Visual Analog Scale Pain Number.|Visual analog pain scale range is 0-10 with 0=no pain and 10 = worst pain ever|in recovery room; post-operative days 1,3,5 & 7|||pain score||Full Range|Mean
765502|NCT00678379|Secondary|Total Time Until Discharge From Hospital.||Day of Surgery|||minutes||Full Range|Median
765503|NCT00678379|Secondary|Median Number of Pain Medication Doses|The median number of intravenous fentanyl doses administered in the PACU due to pain|in recovery room|per group doses||number of doses||Full Range|Median
765504|NCT00678379|Primary|Total Number of Post-operative Doses of Analgesics.|The total number of intravenous fentanyl doses given PACU which will be compared between the three randomized groups (arms)|Post-operative thru day 7|Number of patients randomized to each group||number of doses||Full Range|Median
765505|NCT00678392|Secondary|Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Visual Analog Scale (VAS)|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. VAS component: participants rated their current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health.|Baseline (Predose on Cycle 1 Day 1) , Day 1 of each cycle until Cycle 21, End of treatment (Day 670) and Follow-up visit (Day 698)|"FAS included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized. Here, n signifies those participants who were evaluable for the specified time points."||Units on a scale||Standard Deviation|Mean
765506|NCT00678392|Secondary|Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Health State Profile Utility Score|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility or index score. Health state profile component assesses level of health for 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each domain was rated on a 3-point response scale (1= no problems, 2= some/moderate problems and 3= extreme problems). Scoring formula developed by EuroQol Group assigned a utility value for each domain in the profile. Score were transformed and resulted in a total score range of 0 to 1, with higher scores indicating better health.|Baseline (Predose on Cycle 1 Day 1) , Day 1 of each cycle until Cycle 21, End of treatment (Day 670) and Follow-up visit (Day 698)|"FAS included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized. Here, n signifies those participants who were evaluable for the specified time points."||Units on a scale||Standard Deviation|Mean
765507|NCT00678392|Secondary|Functional Assessment of Cancer Therapy Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Score|FKSI-DRS was used to assess quality of life for those diagnosed with renal cell cancer and consisted of 9 items (lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, and hematuria). Each of the 9 items was answered on a 5-point Likert-type scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI-DRS score = sum of the 9 item scores; total range: 0 - 36; 0 (no symptoms) to 36 (very much); higher scores indicate greater presence of symptoms.|Baseline (Predose on Cycle 1 Day 1) , Day 1 of each cycle until Cycle 21, End of treatment (Day 670) and Follow-up visit (Day 698)|"FAS included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized. Here, n signifies those participants who were evaluable for the specified time points."||Units on a scale||Standard Deviation|Mean
765524|NCT00678470|Primary|Number of Patients Who Were Both Intralesional and Intramuscular Responders.|"Patients were first injected with alefacept into a single target plaque. Those who had improvement in the plaque from baseline were deemed intralesional responders. All the patients then were injected with alefacept intramuscularly. The patients who had a 70% or greater improvement in their psoriasis severity score (includes assessment of entire body) were systemic responders to alefacept. The number of patients who were both intralesional and systemic responders was measured."|12 weeks after intramuscular injection of alefacept.|14 of 18 patients completed the study.||Participants|||Number
769128|NCT00709124|Secondary|Individual Muscle Strength: Pretibial, Triceps Surae, and Quadriceps (MRC Score) Between Those Who Receive NMES vs. Sham Sessions||ICU and hospital discharge||||||
765508|NCT00678392|Secondary|Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15) Score|FKSI was used to assess quality of life (QoL) for those diagnosed with renal cell cancer and consisted of 15 items (lack of energy, side effects, pain, losing weight, bone pain, fatigue, enjoying life, short of breath, worsened condition, appetite, coughing, bothered by fevers, ability to work, hematuria and sleep). Each of the 15 items was answered on a 5-point Likert-type scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI score = sum of the 15 item scores; total range: 0 - 60; 0 (no symptoms) to 60 (very much); higher scores indicate greater presence of symptoms.|Baseline (Predose on Cycle 1 Day 1) , Day 1 of each cycle until Cycle 21, End of treatment (Day 670) and Follow-up visit (Day 698)|"FAS included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized. Here, n signifies those participants who were evaluable for the specified time points."||Units on a scale||Standard Deviation|Mean
765509|NCT00678392|Secondary|Number of Participants With Clinically Significant Laboratory Abnormalities: Urinalysis|Urinalysis included urine blood/ hemoglobin, glucose and protein. Abnormalities were assessed by CTCAE Grade Version 2 for severity: Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling.|From initiation of treatment up to follow-up period (up to 3 years)|"Safety population included all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received. Here, n signifies number of participants available for specified categories for each arm respectively."||Participants|||Number
765510|NCT00678392|Secondary|Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry|Biochemistry laboratory test included parameters: alanine aminotransferase, alkaline phosphatase, amylase, aspartate aminotransferase, bicarbonate, bilirubin, creatinine, hypercalcemia, hyperglycemia, hyperkalemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hyponatremia, hypophosphatemia and lipase. Abnormalities were assessed by CTCAE Grade Version 2 for severity: Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling.|From initiation of treatment up to follow-up period (up to 3 years)|"Safety population included all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received. Here, n signifies number of participants available for specified categories for each arm respectively."||Participants|||Number
765511|NCT00678392|Secondary|Number of Participants With Clinically Significant Laboratory Abnormalities: Hematology|Hematology laboratory test included hemoglobin, platelet count, white blood cells count, neutrophils and lymphocytes. Abnormalities were assessed by CTCAE Grade Version 2 for severity: Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling.|From initiation of treatment up to follow-up period (up to 3 years)|"Safety population included all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received. Here, n signifies number of participants available for specified categories for each arm respectively."||Participants|||Number
765512|NCT00678392|Secondary|Percentage of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life ­threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both serious and non ­serious AEs.|From initiation of treatment up to follow-up period (up to 3 years)|Safety population included all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.||Percentage of participants|||Number
765513|NCT00678392|Secondary|Percentage of Participants With Adverse Events (AEs) by Severity|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severity of the AEs was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Grade 1= mild; Grade 2= moderate; Grade 3= severe; Grade 4= life-threatening or disabling; Grade 5= death related to AE.|From initiation of treatment up to follow-up period (up to 3 years)|Safety population included all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.||Percentage of participants|||Number
765514|NCT00678392|Secondary|Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life­ threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non­serious AEs.|From initiation of treatment up to follow-up period (up to 3 years)|Safety population included all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.||Percentage of participants|||Number
765525|NCT00678470|Primary|To Evaluate the Effectiveness of Intralesional Alefacept Administration as Defined by the Psoriasis Severity Assessment Score Followed by the Evaluation of the Effectiveness of Intramuscular Alefacept Administration.||6 months||||||
765526|NCT00678535|Secondary|Safety - Number of Participants With Adverse Events (AEs)|An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.|Time from first dose up to Day 30 after last dose of study treatment, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date (31 Mar 2012)|The safety population included all participants who received at least one dose of any trial treatment that is, cetuximab, cisplatin, or capecitabine.||participants|||Number
769492|NCT00714233|Secondary|Weight Loss in Lifestyle Intervention Group|In the adolescent women assigned to the lifestyle program, did the intervention program obtain weight reduction as measured by change in BMI|baseline and 24 weeks|Analysis per protocol||kg/m^2||Standard Deviation|Mean
765515|NCT00678392|Secondary|Duration of Response (DR)|DR: time from first documentation of objective tumor response (CR or PR), that was subsequently confirmed, to the first documentation of PD or to death due to any cause, whichever occurred first as per RECIST version 1.0, a) CR: disappearance of all target, non target lesions and no appearance of new lesions, documented on 2 occasions separated by at least 4 weeks, b) PR: at least 30 % decrease in sum of LD of target lesions taking as reference baseline sum of LD, without progression of non target lesions, no appearance of new lesions, c) PD: >=20% increase in sum of LD of the target lesions taking as a reference smallest sum of LD recorded since the start of treatment or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. Occurrence of pleural effusion or ascites if demonstrated by cytological investigation, not previously documented. New bone lesions not previously documented if confirmed by computed tomography/magnetic resonance imaging or X-ray.|From initiation of treatment up to follow-up period (up to 3 years)|FAS included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.||Months||95% Confidence Interval|Median
765516|NCT00678392|Secondary|Objective Response Rate (ORR)|ORR = percentage of participants with confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.0 recorded from first dose of study treatment until PD or death due to any cause. CR: disappearance of all target, non target lesions and no appearance of new lesions, documented on 2 occasions separated by at least 4 weeks. PR: at least 30 % decrease in sum of LD of target lesions taking as reference baseline sum of LD, without progression of non target lesions, no appearance of new lesions. PD: >=20% increase in sum of LD of the target lesions taking as a reference smallest sum of LD recorded since the start of treatment or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. Occurrence of pleural effusion or ascites if demonstrated by cytological investigation, not previously documented. New bone lesions not previously documented if confirmed by computed tomography/magnetic resonance imaging or X-ray.|From initiation of treatment up to follow-up period (up to 3 years)|FAS included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.||Percentage of participants||95% Confidence Interval|Number
765517|NCT00678392|Secondary|Overall Survival (OS)|OS was defined as the duration from start of study treatment to date of death due to any cause. OS was calculated as (months) = (date of death minus the date of first dose of study medication plus 1) divided by 30.4. For participants who were alive, overall survival was censored on last date the participants were known to be alive.|From initiation of treatment up to follow-up period (up to 3 years)|FAS included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.||Months||95% Confidence Interval|Median
765518|NCT00678392|Primary|Progression-Free Survival (PFS)|PFS was defined as the time in months from start of study treatment to the first documentation of objective tumor progression of disease (PD) or to death due to any cause, whichever occurs first. PD was assessed by response evaluation criteria in solid tumors (RECIST) version 1.0. PD: >=20 percent (%) increase in the sum of the longest dimensions (LD) of the target lesions taking as a reference the smallest sum of the LD recorded since the start of treatment or unequivocal progression in non-target lesions or the appearance of 1 or more new lesions. Occurrence of a pleural effusion or ascites was also considered PD if demonstrated by cytological investigation and it was not previously documented. New bone lesions not previously documented were considered PD if confirmed by computed tomography/magnetic resonance imaging or X-ray.|From initiation of treatment up to follow-up period (up to 3 years)|FAS included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.||Months||95% Confidence Interval|Median
765519|NCT00678418|Secondary|Change in Percentage of Self-reported Opioid-free Days From Baseline to Week 24|Opioid use was measured using subjects' entries on a validated Timeline FollowBack (TLFB) calendar in which they recorded their use/non-use of opioids each day.|24 Weeks|Analyses include all randomized subjects who received at least 1 dose of study drug (ITT population). Change from baseline was calculated per subject as the percent of subjects' self-reported opioid-free days in Part A minus the percent of opioid-free days prior to the subjects' hospitalization for pre-study detoxification.||Percentage of opioid-free days||Inter-Quartile Range|Median
765520|NCT00678418|Secondary|Incidence of Subjects Who Relapsed to Physiologic Opioid Dependence During the 24-week Treatment Period (Part A)|Assessment of relapse to physiologic opioid dependence was based on individual subjects' results on the naloxone challenge test. A positive naloxone challenge test result was considered as a relapse to physiologic opioid dependence.|24 Weeks|Analyses include all randomized subjects who received at least 1 dose of study drug (ITT population).||Percentage of participants who relapsed|||Number
765521|NCT00678418|Secondary|Craving Score: Change From Baseline|"Measured using subjects' response on a validated Visual Analog Scale at prespecified weekly visits throughout Part A, with comparison of baseline to end of Part A. The scale ranged from 0 (No craving) to 100 (highest possible craving)."|Baseline to 6 months (24 weeks)|Analyses include all randomized subjects who received at least 1 dose of study drug (ITT population).||Units on a scale||95% Confidence Interval|Least Squares Mean
765522|NCT00678418|Secondary|Days to Discontinuation During Part A|Defined as the duration of study participation and calculated as the number of days from Dose 1 to the day of study discontinuation.|168 days (24 weeks)|Analyses include all randomized subjects who received at least 1 dose of study drug (ITT population).||Days to study discontinuation||95% Confidence Interval|Median
765523|NCT00678418|Primary|Percentage (%) of Opioid-free Weeks Per Subject in Double-blind Period (Part A)|Included are data from the last 20 weeks of the 24-week double-blind treatment period (Part A). Response profiles for each Arm are based on subjects' individual rates of weekly opioid-free data, including negative urine test results, attendance at study visits, and self-reports of opioid use/non-use.|20 weeks|Analyses include all randomized subjects who received at least 1 dose of study drug (Intent-to-treat [ITT] population).||Percentage of opioid-free weeks||Inter-Quartile Range|Median
769716|NCT00706485|Secondary|Marginal Failure.|Marginal failure is defined as appearance of tumor growth at the margin of dural plaque.|up to 10 years|Study was closed without analysis of anatomic sites of failure. No data were collected for this outcome.|||||
765527|NCT00678535|Secondary|Quality of Life (QoL) Assessed by EuroQol 5Dimensions (EQ-5D) Questionnaire|EQ-5D questionnaire is a measure of health status that provides a simple descriptive profile and a single index value. The EQ-5D defines health in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 5 single items are combined to obtain a single index score that is health utility index (HUI) score reflecting subject's preferences for different health states. The lowest possible score is -0.59 and the highest is 1.00, higher scores on the EQ-5D represent a better QoL.|Baseline, Week 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date (31 Mar 2012)|Analysis population included participants who had at least one evaluable EuroQoL EQ-5D questionnaire and were also included in the ITT population. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
765528|NCT00678535|Secondary|Quality of Life (QoL) Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)|Mean global health status and social functioning scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a better QoL.|Baseline, Week 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date (31 Mar 2012)|Analysis population included participants who had at least one evaluable EORTC QLQ-C30 questionnaire and were also included in the ITT population. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
765529|NCT00678535|Secondary|Best Overall Response (BOR) Rate: Independent Review Committee (IRC) Assessments|The BOR rate is defined as the percentage of participants having achieved complete response (CR) or partial response (PR) as the best overall response, based on radiological assessments (based on response evaluation criteria in solid tumors [RECIST] Version 1.0) from the IRC.|Every 6 weeks until progression, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date, (31 Mar 2012)|ITT population included all participants who were randomized to trial treatment.||percentage of participants||95% Confidence Interval|Number
765530|NCT00678535|Secondary|Overall Survival (OS)|The OS time is defined as the time from randomization to death or last day known to be alive. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.|Time from randomization to death or last day known to be alive, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date, (31 Mar 2012)|ITT population included all participants who were randomized to trial treatment.||months||95% Confidence Interval|Median
765531|NCT00678535|Primary|Progression-free Survival (PFS) Time: Independent Review Committee (IRC) Assessments|The PFS time is defined as the duration from randomization to either first observation of progressive disease (PD) or occurrence of death due to any cause within 60 days of the last tumor assessment or randomization. Participants without event are censored on the date of last tumor assessment.|Time from randomization to disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date (31 Mar 2012)|Intent-to-treat (ITT) population included all participants who were randomized to trial treatment.||months||95% Confidence Interval|Median
765532|NCT00678574|Primary|Change in Cortical Gama-aminobutyric Acid Levels (GABA Levels) Pre and Post SSRI Treatment|GABA levels would be assessed during the follicular and mid-luteal phases of the menstrual cycle pre and post treatment with the SSRI.|2-3 months post-treatment w/ fluoxetine.|This study was conducted at Yale several years ago. Our group at UPenn only has basic information about this study. This includes the number of participants, which was 18, and that no adverse events occurred. The contact person who initially entered this study protocol information is no longer at the University of Pennsylvania.|||||
765533|NCT00678587|Secondary|Mean Number of Unscheduled Office Visits, Unscheduled Laboratory Tests, and Unscheduled Procedures|The number of unscheduled events was analyzed as an indication of medical resource utilization throughout the study.|Prior to, during, and up to 4 weeks (30 days) following elective invasive procedures (Days 16-19); therefore, this covers a time period from Baseline to Day 26|ITT Population. Data are missing for some participants.||unscheduled events||Standard Deviation|Mean
765534|NCT00678587|Secondary|Mean Number of Days Spent in the Hospital|The number of days spent in the hospital was analyzed as an indication of medical resource utilization throughout the study.|Prior to, during, and up to 4 weeks (30 days) following elective invasive procedures (Days 16-19); therefore, this covers a time period from Baseline to Day 26|ITT Population. Data are missing for some participants.||days||Standard Deviation|Mean
765535|NCT00678587|Secondary|Pharmacokinetics (PK) of Eltrombopag, CL/F|CL/F is the apparent plasma clearance, where CL is an estimate of the total body clearance, and F is the fraction of dose absorbed. Total clearance is the volume of blood cleared of the drug by the various elimination processes (metabolism and excretion) per unit time.|Day 14|PK Subpopulation||Liters/hour||95% Confidence Interval|Geometric Mean
765536|NCT00678587|Secondary|Pharmacokinetics (PK) of Eltrombopag, t1/2|t1/2 is the half life of a drug based on its terminal phase. Half life is defined as the time necessary to halve the plasma concentration.|Day 14|PK Subpopulation||hours||95% Confidence Interval|Geometric Mean
765537|NCT00678587|Secondary|Pharmacokinetics (PK) of Eltrombopag, Cmax|Cmax is the steady state peak plasma concentration of a drug observed after its administration.|Day 14|PK Subpopulation||ug/mL||95% Confidence Interval|Geometric Mean
765538|NCT00678587|Secondary|Pharmacokinetics (PK) of Eltrombopag, Steady State AUC(0-tau)|AUC(0-tau) is the area under a concentration versus time curve between dose interval following repeat dosing. It is a measure of systemic drug exposure.|Day 14|PK Subpopulation: all participants who were treated with eltrombopag and provided evaluable PK samples||hour*micrograms (ug)/milliliter (mL)||95% Confidence Interval|Geometric Mean
765539|NCT00678587|Secondary|Number of Participants With a Clinically Significant Change in Electrocardiogram (ECG) Results|A 12-lead ECG was obtained in duplicate at screening, baseline, Day 15, and withdrawal from the study. Participants rested supine for 5 minutes before the 12-lead ECG was recorded. A 30 second rhythm strip was obtained, and the ECG was calibrated, labelled, and initialled by the person performing the recording. A written, interpretive assessment detailing clinical significance was produced, dated, and signed off by the physician at the site.|Screening, Baseline, Day 15, and Withdrawal|Safety Population. Data were missing for some participants.||participants|||Number
765540|NCT00678587|Secondary|Number of Participants With Renal Function Abnormality|Renal function abnormality was defined by threshold values for: serum creatinine: change from baseline of >=0.3 and <0.5 milligrams (mg)/deciliter (dL) (>=26.6 and <44.3 micromoles [umol]/L) or change from baseline of >=0.5 mg/dL (>=44.3 umol/L); microscopic urine analysis: cellular casts pathologic (as defined by local standards of microscopic urine analysis); urine protein/creatinine ratio (UP/CR): >0.5 mg/mg; Glomerular Filtration Rate (GFR) as determined by the Cockcroft-Gault formula and urine dipstick test.|Screening to Procedure +30 day follow-up or early withdrawal|Safety Population||participants|||Number
765541|NCT00678587|Secondary|Number of Participants With the Indicated Event Relating to Vision|The progression of pre-existing cataracts was measured by the use of slit lamp examination. Decrease in visual acuity is defined as the loss of 3 or more lines of visual acuity in either eye (0.3 log minimal angle of resolution [logMAR], 15 letters on the standard Early Treatment Diabetic Retinopathy Study chart).|Screening or Baseline and at End of Study (Procedure +30 day follow-up or withdrawal visit)|Safety Population: all randomized participants who received at least one dose of study medication. Data are missing for some participants.||participants|||Number
765542|NCT00678587|Secondary|Number of Participants With a Serious Adverse Event That Occurred in Greater Than One Participant||Screening to Procedure +30 day follow-up or early withdrawal|Safety Population||participants|||Number
765543|NCT00678587|Secondary|Number of Participants Experiencing an Adverse Event (AEs) and Serious Adverse Event (SAEs) Within the Indicated Category|An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect or an ocular event of clinical concern. Medical or scientific judgement is exercised in deciding whether reporting is appropriate in other situations.|Screening to Procedure +30 day follow-up or early withdrawal|Safety population: all randomized participants who received at least one dose of study medication||participants|||Number
765544|NCT00678587|Secondary|Number of Participants With the Indicated Platelet Count at Screening; Days 8 and 15; Procedure + 7, 14, 21, 30 Day Follow-up (FU); and Maximum Post-baseline|Procedure +7 = Days 23-26; +14 = Days 30-33; +21 = Days 37-40; +30 = Days 46-49. Early withdrawal can occur at any time. Maximum post-baseline refers to any time point listed above for which the maximum value was reached (therefore this time point is variable).|Screening; Days 8 and 15; Procedure + 7, 14, 21, 30 day follow-up; and maximum post-baseline|ITT Population. The number of participants analyzed decreases over time due to missing measurements and to participants dropping out of the study.||participants|||Number
765545|NCT00678587|Secondary|Median Platelet Count at Screening; Days 1, 8, 15, 16-19; Procedure + 7, 14, 21, 30 Day Follow-up; Early Withdrawal; and Maximum Post-baseline|Procedure +7 = Days 23-26; +14 = Days 30-33; +21 = Days 37-40; +30 = Days 46-49. Early withdrawal can occur at any time. Maximum post-baseline refers to any time point listed above for which the maximum value was reached (therefore this time point is variable).|Screening; Days 1, 8, 15, 16-19; Procedure + 7, 14, 21, 30 day follow-up; early withdrawal; and maximum post-baseline|ITT Population. The number of participants analyzed decreases over time due to missing measurements and to participants dropping out of the study.||Gi/L||Full Range|Median
765546|NCT00678587|Secondary|Number of Participants With the Indicated Number of Platelet Transfusions Administered|Platelet transfusion use was documented at every visit throughout the study from screening until the 4-week (30-day) post-procedure follow-up visit or at the time of participant withdrawal from the study.|Prior to, during, and up to 4 weeks (30 days) following elective invasive procedures (Days 16-19); therefore, this covers a time period from Baseline to Day 26|ITT Population||participants|||Number
765547|NCT00678587|Secondary|Number of Participants With a World Health Organization (WHO) Bleeding Score >=2 During and up to 7 Days Following Elective Invasive Procedures|The WHO Bleeding Scale was used to assess bleeding during the study. The range of possible scores is 0 to 4. Grade 0 is no bleeding; Grade 1 is petechiae (small [1-2 millimeter] red or purple spot on the body, caused by a minor hemorrhage); Grade 2 is mild blood loss; Grade 3 is gross blood loss (requiring a transfusion; and Grade 4 is debilitating blood loss (retinal or cerebral associated with fatality).|Prior to, during, and up to 7 days following elective invasive procedures (Study Days 16-19); therefore, this covers a time period from Baseline to Day 26|ITT Population||participants|||Number
765548|NCT00678587|Primary|Number of Participants With Chronic Liver Disease and Thrombocytopenia (Platelets <50 Gi/L) Who do Not Require a Platelet Transfusion Prior to, During, and up to 7 Days Following Elective Invasive Procedures|A platelet transfusion was given if the platelet count was <50 giga (10^9) per liter (Gi/L) before the procedure. A platelet transfusion was not given if the platelet count was >80 Gi/L (based on a primary endpoint of success). For participants with platelet counts between 50 Gi/L and 80 Gi/L, platelet transfusions were administered at the discretion of the investigator and the physician performing the elective invasive procedure.|Prior to, during, and up to seven days following elective invasive procedures (Study Days 16-19); therefore, this covers a time period from Baseline to Day 26|Intent-to-Treat (ITT) Population: all participants who were randomized to treatment||participants|||Number
765549|NCT00678639|Secondary|Adverse Events During Magnetic Resonance Imaging (MRI) Scanning|Any event leading to early termination of the MRI acquisition, or requiring intervention by a physician, will be considered an adverse event related to MRI, excluding physician termination of image acquisition due to concerns of cardiac ischemia.|Occuring in the MRI scanning suite or within 30 minutes of the last image acquisition.|Only participants undergoing Cardiac MRI scanning are eligible for this endpoint. Only 49 of the 53 participants randomized to observation unit arm underwent CMR testing. Nine participants in the usual care arm underwent CMR testing.||Participants|||Number
765550|NCT00678639|Secondary|Number of Participants Who Utilized the Indicated Health Care Procedures|Measured as self report, assessed during telephone follow-up.|30d, 3mo, 6mo, and 1 year|Data reported through 30 days. Follow-up with participants is ongoing. Results will be updated once follow-up is complete.||Participants|||Number
765551|NCT00678639|Secondary|The Number of Participants Randomized to the OU and Were Able to Complete CMR Imaging|The number of participants able to complete the planned imaging sequences will be measured.|Emergency Department (ED) arrival through hospital discharge|All participants randomized to the Observation Unit - Cardiac Magnetic Resonance Imaging (OU-CMR) arm were analyzed based on intention to treat.||Participants|||Number
765552|NCT00678639|Secondary|Correct Admission Decision, Based Upon the Reference Standard of Acute Coronary Syndrome (ACS) at 30 Days|Participants with ACS and admitted or not experiencing ACS and discharged will be considered a correct admission decision. Remaining participants will be considered to have incorrect admission decisions.|30 Days|4 participants (3 in the usual care group and 1 in the ED obs unit group) left Against Medical Advice (AMA) prior to completion of their evaluation and were excluded from this analysis. Analysis was per intention to treat.||Participants|||Number
765553|NCT00678639|Primary|Cost of Index Hospitalization|Index hospitalization refers to the hospital visit during which the participant was enrolled in the trial. The primary outcome is examining the cost for this visit.|Emergency Department (ED) arrival through hospital discharge, median length of stay was 28.1 hours|All participants were analyzed based on intention to treat.||US Dollars||Inter-Quartile Range|Median
765554|NCT00678691|Primary|Brief Fatigue Inventory|This scale measures overall fatigue due to medical illness. range is 0-80 with 80 being severe fatigue|8 weeks|last observation carried forward after power analysis calculated||units on a scale||Standard Deviation|Mean
765555|NCT00678795|Secondary|Change From Baseline in the Mean Number of Daily Voids at the End of Treatment|Baseline was the average of all available data recorded during the 14 days immediately prior to the randomisation visit. End of Treatment was the last average available from Week 3, Week 5, and Weeks 7-8. A negative value indicates an improvement in score from baseline.|0 - 10 weeks|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.||number of daily episodes||Standard Deviation|Mean
765556|NCT00678795|Secondary|Patient’s Global Impression of Change|Subjects were asked at completion or withdrawal to give their impression of the overall change in their condition since entry into the study using the following seven-point scale: 1 = ‘Very Much Improved’, 2 = ‘Much Improved’, 3 = ‘Minimally Improved’, 4 = ‘No Change’, 5 = ‘Minimally Worse’, 6 = ‘Much Worse’, 7 = ‘Very Much Worse’. The numbers who scored 1, 2, or 3 are presented.|0 - 10 weeks|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.||participants|||Number
765557|NCT00678795|Secondary|Change From Baseline in Mean Overall Bladder Condition 0-10 Numerical Rating Scale Score at the End of Treatment|Subjects subjectively assessed the severity of their urinary incontinence and general bladder symptoms by responding to the following question on a Numerical Rating Scale: My bladder condition, taking everything into account, causes me: 0 = “no problems” and 10 = “intolerable problems”. Baseline was the average of all available data recorded during the 14 days immediately prior to the randomisation visit. End of Treatment was the last average available from Week 3, Week 5, and Weeks 7-8. A negative value indicates an improvement in score from baseline.|0 - 10 weeks|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.||units on a scale||Standard Deviation|Mean
765558|NCT00678795|Secondary|Change From Baseline in Mean Total Incontinence Quality of Life (I-QOL) Questionnaire Score at the End of Treatment (Completion or Withdrawal)|The I-QOL consists of 22 items from three subscales; avoidance/limiting behaviour (eight items), psychosocial impact (nine items) and social embarrassment (five items). The responses to each of the 22 items were summed and averaged for a total score and then transformed to a 0-100 scale for ease of interpretation. The transformation formula used for the I-QOL total scores is: Transformed score = 100 x (the sum of the items - lowest possible score) / Possible raw score range. An increase in score indicates an improvement in QOL.|0 - 10 weeks|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.||units on a scale||Standard Deviation|Mean
765559|NCT00678795|Secondary|Change From Baseline in the Mean Daily Number of Incontinence Pads Used at the End of Treatment|Subjects documented in the daily subject diary, the total number of incontinence pads they had used each day. Baseline was the average of all available data recorded during the 14 days immediately prior to the randomisation visit. End of Treatment was the last average available from Week 3, Week 5, and Weeks 7-8. A negative value indicates an improvement in score from baseline.|0 - 10 weeks|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.||pads used daily||Standard Deviation|Mean
765560|NCT00678795|Secondary|Change From Baseline in the Mean Daily Episodes of Nocturia at the End of Treatment|Subjects documented in the daily subject diary each instance of nocturia, and the time that each took place (as for the recording of incontinence episode frequency). Baseline was the average of all available data recorded during the 14 days immediately prior to the randomisation visit. End of Treatment was the last average available from Week 3, Week 5, and Weeks 7-8. A negative value indicates an improvement in score from baseline.|0 - 10 weeks|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.||number of daily episodes||Standard Deviation|Mean
765561|NCT00678795|Secondary|Change From Baseline in the Mean Daily Episodes of Urgency at the End of Treatment|Subjects documented in the daily subject diary each instance of urgency, and the time that each took place, as for the recording of incontinence episode frequency. Baseline was the average of all available data recorded during the 14 days immediately prior to the randomisation visit. End of Treatment was the last average available from Week 3, Week 5, and Weeks 7-8. A negative value indicates an improvement in score from baseline.|Daily diary entries throughout 10 week study period|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.||number of daily episodes||Standard Deviation|Mean
765562|NCT00678795|Primary|Change From Baseline in the Mean Daily Number of Incontinence Episodes at the End of Treatment|To assess the effect of Sativex in neurogenic overactive bladder, the incontinence episode frequency was selected as the primary endpoint. Baseline was the average of all available data recorded during the 14 days immediately prior to the randomisation visit. End of Treatment was the last average available from Week 3, Week 5, and Weeks 7-8. A negative value indicates an improvement in score from baseline.|0 - 10 weeks|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.||number of daily episodes||Standard Deviation|Mean
765822|NCT00681863|Secondary|Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale|Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe).|baseline and Week 20|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.||Score on a scale||Standard Deviation|Mean
765563|NCT00678834|Primary|"The Levels of TCT in the Tissues of Non-healthy Subjects and in the Tissue of Healthy Subjects Following Oral Supplementation (200 mg x 2 Per Day for 4-24 Weeks)"||After at least 1 month of supplementation|Box plots were used to determine outliers defined as values . the 75th percentile plus 1.5 times the IQR or values , the 25th percentile minus 1.5 times the IQR (20). Outliers were identified and it was determined that laboratory procedural errors were the cause and thus removed from the analysis.||nmol/g||Standard Deviation|Mean
765564|NCT00678886|Secondary|Percent Change From Baseline in CD3/TCR Modulation on CD4+ T Cells and CD8+ T Cells at Day 1, Day 4, Day 8|The extent of modulation of CD3/TCR receptors on CD4+ and CD8+ lymphocytes was determined by flow cytometry. The extent of TCRαβ expression was determined using an antibody that bound to TCRαβ but did not compete with otelixizumab for binding sites at the expected range of concentrations. The MESF of the anti-TCRαβ antibody was used to quantify the number of CD3/TCR complexes present on T cells. The MESF of bound biotinylated otelixizumab was directly proportional to the availability of free otelixizumab binding sites.CD3/TCR complexes on CD4+ and CD8+ T cells were detected with a non-competing antibody. Changes in the MESF of TCR expression was a direct measurement of TCR modulation. Baseline assessments were carried out on the morning of Day 1, before the start of the first infusion of study drug. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at Day 1, Day 4 and Day 8.|Baseline (Pre-dose Day 1), Day 4, Day 8|ITT population. Only those participants available at the specified time points were analyzed.||Percent change||Standard Error|Mean
765565|NCT00678886|Secondary|Percent Change From Baseline in CD3/TCR Saturation on CD4+ T Cells and CD8+ T Cells at Day 1, Day 4, Day 8|The extent of saturation of CD3/TCR receptors on CD4+ and CD8+ lymphocytes was determined by flow cytometry. The extent of TCRαβ expression was determined using an antibody that bound to TCRαβ but did not compete with otelixizumab for binding sites at the expected range of concentrations. The MESF of the anti-TCRαβ antibody was used to quantify the number of CD3/TCR complexes present on T cells. The MESF of bound biotinylated otelixizumab was directly proportional to the availability of free otelixizumab binding sites. MESF of free CD3 sites on CD4+ T cells and CD8+ T cells was direct measurement of saturation of the CD3/TCR complex on CD4+ T cells and CD8+ T cells. Baseline assessments were carried out on the morning of Day 1, before the start of the first infusion of study drug. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at Day 1, Day 4 and Day 8.|Baseline (Pre-dose Day 1), Day 4, Day 8|ITT population. Only those participants available at the specified time points were analyzed.||Percent change||Standard Error|Mean
765566|NCT00678886|Secondary|Percent Change From Baseline in Cell-bound Otelixizumab on CD4+ T Cells at Day 1, Day 4, Day 8|The amount of cell-bound otelixizumab was determined by flow cytometry. The extent of T cell receptor alpha beta (TCRαβ) expression was determined using an antibody that bound to TCRαβ but did not compete with otelixizumab for binding sites at the expected range of concentrations. The MESF of the anti-TCRαβ antibody was used to quantify the number of CD3/TCR complexes present on T cells. Free otelixizumab binding sites (sites not occupied by otelixizumab) were detected by staining with biotinylated otelixizumab. The MESF of bound biotinylated otelixizumab was directly proportional to the availability of free otelixizumab binding sites. MESF of bound antibody on CD4+ T cells was a direct measurement of cell-bound otelixizumab on CD4+ T cells. Baseline assessments were carried out on the morning of Day 1, before the start of the first infusion of study drug. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at Day 1, Day 4 and Day 8.|Baseline (pre-dose on Day 1), Day 4 and Day 8|ITT population. Only those participants available at the specified time points were analyzed.||Percent change||Standard Error|Mean
765567|NCT00678886|Secondary|Percent Change From Baseline in Circulating Peripheral Lymphocytes CD4+CD25+FoxP3+ T Cells and CD4+CD25hiFoxP3+ T Cells in Type 1 Diabetes Mellitus (TIDM) up to Month 12|Blood samples were drawn for lymphocyte subset evaluations at Baseline and at 2hours after EOI on Day 4, pre-dose and after E0I on Day 8, Day 14, Day 21, Day 28, Week 6, Week 8, Week 10, Week 12, Month 6 and Month 12. Percentages of relevant lymphocyte subsets were determined by flow cytometry. The lymphocyte subsets assessed included CD8+CD25+ T lymphocytes, as well as the subsets of lymphocytes of these type that were positive for FoxP3, a protein that was expressed at high levels in the cytoplasm of regulatory T cells. CD4+CD25hiFoxP3+ T lymphocytes, a cell type was of interest because it played a regulatory role in T1DM. Baseline assessments were carried out on the morning of Day 1, before the start of the first infusion of study drug. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at the time of assessment.|Baseline (pre-dose on Day 1) and up to 12 Months|ITT population. Only those participants available at the specified time points were analyzed.||Percent change||Full Range|Median
765568|NCT00678886|Secondary|Change From Baseline in Level of Cytokines Interleukin (IL-6), IL-10 and Tumor Necrosis Factor-alpha (TNF-a) at Day 1, Day 4, Day 8|Levels of cytokine (TNFα, IL-6, IL-10) were measured at Baseline and at 2 hours after end of infusion (EOI) on Day 1, Day 4, Day 8 . Baseline assessments were carried out on the morning of Day 1, before the start of the first infusion of study drug. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at Day 1, Day 4 and Day 8.|Day 1, Day 4, Day 8|ITT population. Only those participants available at the specified time points were analyzed.||picograms per milliliter||Standard Error|Mean
765569|NCT00678886|Secondary|Composite Rank Summary for C-Peptide AUC, HbA1c and Exogenous Insulin Use at Month 6 and Month 12|O’Brien analyses will be performed on a three-part composite of HbA1c level, C-peptide AUC, and mean daily Insulin use in the otelixizumab group compared with the placebo group at Months 6 and12. For the O’Brien mean rank analysis at a particular time point, HbA1c and insulin use will be ranked from smallest to largest, and C-peptide AUC will be ranked from largest to smallest. For each participant, the C-Peptide AUC, ranks for HbA1c and insulin use were added together, producing a composite rank. A treatment comparison test was then performed on the composite ranks.|Month 6 and 12|ITT population. Only those participants available at the specified time points were analyzed.||Composite rank score||Standard Deviation|Mean
765585|NCT00678899|Secondary|Consonant Nucleus Consonant (CNC) Monosyllabic Words - Treated Ear|"Secondary efficacy endpoints using binomial comparisons (based on the postoperative Hybrid condition) are as follows:
The CNC Words test consists of 10 recorded lists of 50 monosyllabic words in CD format. For this study, two lists will be administered in quiet at a level equal to 60 dBA in the sound field. The percentage of subjects that scored equal to or better than they did in the pre-operative unilateral acoustic-only condition will be reported."|6 Months Postactivation|||percentage of subjects|||Number
765570|NCT00678886|Secondary|Composite Rank Summary for HbA1c and Exogenous Insulin Use at Month 6 and Month 12|O’Brien mean rank analyses was performed on a two-part composite of the baseline-adjusted HbA1c level and the baseline-adjusted mean total daily insulin use per kg body weight in the otelixizumab group compared with the placebo group at Months 6, 12. For the O’Brien mean rank analysis at a particular time point, adjusted HbA1c values (for both treatment groups together) was ranked from smallest to largest, and adjusted mean daily insulin use values were ranked from smallest to largest. For each participant, the HbA1c and insulin use ranks were added together, producing a composite rank. A treatment comparison test was then performed on the composite ranks.|Month 6 and 12|ITT population. Only those participants available at the specified time points were analyzed.||Composite rank score||Standard Deviation|Mean
765571|NCT00678886|Secondary|Change From Baseline in Average Daily Risk Range (ADRR) at Week 12 and Months 6 and 12.|Average daily risk range is a measure for evaluation of blood glucose variability that was designed to be equally sensitive to hypoglycemia and hyperglycemia. The ADRR was assessed over 30-day periods prior to Baseline and at key visits Week 12 and Months 6 and 12. Baseline assessments were carried out on the morning of Day 1, before the start of the first infusion of study drug. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at Week 12 and Months 6 and 12.|Baseline (Day 1) and Week 12, Months 6 and 12.|ITT population.||Ratio||Standard Error|Least Squares Mean
765572|NCT00678886|Secondary|Number of Participants With Hyperglycemic Excursions With Most Complete Glucose at Week 12 and Months 6 and 12|Percentage of hyperglycemic excursions was calculated as the total number of observations that exceed the hyperglycemic excursion boundary (i.e. > HGTLV) divided by the total number of glucose measurements recorded in a time interval for the intervals: Baseline to Week 12, post-Week 12 to Month 6, post-Month 6 to Month 12. Most complete glucose interval was the 7 day period with the maximum number of days with at least 4 recordings per day. If these results were in more than one 7 day period, then the 7 day period with the largest average number of daily recordings (out of those with the maximum number of days with at least 4 recordings per day) was selected. If there were 2 or more 7 day periods that have the same number of days with at least 4 recordings and the same maximum average number of glucose recordings, the period that ended closest to the day of the study was selected. Data for number of participants with their percentages are presented.|Week 12 and Months 6 and 12|ITT population. Only those participants available at the specified time points were analyzed.||Participants|||Count of Participants
765573|NCT00678886|Secondary|Magnitude of Greatest Hyperglycemic Excursions With Most Complete Glucose at Week 12 and Months 6 and 12.|The greatest hyperglycemic excursions during an interval was calculated as the largest recorded glucose level in the interval minus the hyperglycemic tolerance limit value (HGTLV). If a participant had data recorded during the interval but did not have a value above the HGTLV, the participants greatest hyperglycemic excursion for that interval was 0 mg/dL. Most complete glucose interval was the 7 day period with the maximum number of days with at least 4 recordings per day. If these results were in more than one 7 day period, then the 7 day period with the largest average number of daily recordings (out of those with the maximum number of days with at least 4 recordings per day) was selected. If there were 2 or more 7 day periods that have the same number of days with at least 4 recordings and the same maximum average number of glucose recordings, the period that ended closest to the day of the study was selected.|Week 12 and Months 6 and 12.|ITT population. Only those participants available at the specified time points were analyzed.||milligrams per deciliter||Standard Error|Mean
765574|NCT00678886|Secondary|Number of Hyperglycemic Excursions With Most Complete Glucose at Week 12 and Months 6 and 12.|The event frequency of glucose measurements that were hyperglycemic excursions were calculated on a per participant basis using the number of occurrences where blood glucose was greater than the hyperglycemic tolerance limit. There were 3 hyperglycemic tolerance limits considered: 200 mg/dL, 130 mg/dL and 100 mg/dL. Most complete glucose interval was the 7 day period with the maximum number of days with at least 4 recordings per day. If these results were in more than one 7 day period, then the 7 day period with the largest average number of daily recordings (out of those with the maximum number of days with at least 4 recordings per day) was selected. If there were 2 or more 7 day periods that have the same number of days with at least 4 recordings and the same maximum average number of glucose recordings, the period that ended closest to the day of the study was selected.|Week 12 and Months 6 and 12|ITT population. Only those participants available at the specified time points were analyzed.||Hyperglycemic excursions||Standard Error|Mean
765575|NCT00678886|Secondary|Number of Participants With Hypoglycemic Excursions With Most Complete Glucose at Week 12 and Months 6 and 12|Percentage of hypoglycemic excursions was calculated as the total number of observations that exceed the hypoglycemic excursion boundary (i.e.<= 70 mg/dL) divided by the total number of glucose measurements recorded in a time interval for the intervals: Baseline to Week 12, post-Week 12 to Month 6, post-Month 6 to Month 12. Most complete glucose interval was the 7 day period with the maximum number of days with at least 4 recordings per day. If these results were in more than one 7 day period, then the 7 day period with the largest average number of daily recordings (out of those with the maximum number of days with at least 4 recordings per day) was selected. If there were 2 or more 7 day periods that have the same number of days with at least 4 recordings and the same maximum average number of glucose recordings, the period that ended closest to the day of the study was selected. Data has been presented for number of participants with their percentages having hypoglycemic excursion.|Week 12 and Months 6 and 12|ITT population. Only those participants available at the specified time points were analyzed.||Participants|||Count of Participants
765576|NCT00678886|Secondary|Magnitude of Greatest Hypoglycemic Excursions With Most Complete Glucose at Week 12 and Months 6 and 12.|"The greatest hypoglycemic excursions during an interval was calculated as 70 mg/dL minus the lowest recorded glucose level in the interval. If a participant had data recorded during the interval but did not have a value below 70 mg/dL, the participants greatest hypoglycemic excursion for that interval was 0 mg/dL.
Most complete glucose interval was the 7 day period with the maximum number of days with at least 4 recordings per day. If these results were in more than one 7 day period, then the 7 day period with the largest average number of daily recordings (out of those with the maximum number of days with at least 4 recordings per day) was selected. If there were 2 or more 7 day periods that have the same number of days with at least 4 recordings and the same maximum average number of glucose recordings, the period that ended closest to the day of the study was selected."|Week 12 and Months 6 and 12.|ITT population. Only those participants available at the specified time points were analyzed.||milligrams per deciliter||Standard Error|Mean
765577|NCT00678886|Secondary|Number of Hypoglycemic Excursions (<=70 mg/dL) With Most Complete Glucose at Week 12 and Months 6 and 12.|The event frequency of glucose measurements that were hypoglycemic excursions were calculated per participant basis, using the number of occurrences where blood glucose was less than or equal to 70 mg/dL. Most complete glucose interval was the 7 day period with the maximum number of days with at least 4 recordings per day. If these results were in more than one 7 day period, then the 7 day period with the largest average number of daily recordings (out of those with the maximum number of days with at least 4 recordings per day) was selected. If there were 2 or more 7 day periods that have the same number of days with at least 4 recordings and the same maximum average number of glucose recordings, the period that ended closest to the day of the study was selected.|Week 12 and Months 6 and 12.|ITT population. Only those participants available at the specified time points were analyzed.||Hypoglycemic excursions||Standard Error|Mean
765578|NCT00678886|Secondary|Number of Participants With Hypoglycemic Events Defined by Hypoglycemic Event Categories From Baseline Upto Month 12|Hypoglycemic events reported by participants were classified as defined by the ADA Workgroup on Hypoglycemia as Severe hypoglycemia: an event requiring assistance of another person to actively administer carbohydrate, glucagon/other resuscitative actions, documented symptomatic hypoglycemia: an event during which typical symptoms of hypoglycemia are accompanied by a measured plasma glucose concentration (PGC)<=70 mg/dL, asymptomatic hypoglycemia: an event not accompanied by typical symptoms of hypoglycemia but with a measured PGC<=70 mg/dL,probable symptomatic hypoglycemia: an event during which symptoms of hypoglycemia are not accompanied by a plasma glucose determination, but were presumably caused by a PGC<=70 mg/dL and relative hypoglycemia: an event during which the person with diabetes reports any of the typical symptoms of hypoglycemia, and interprets the symptoms as indicative of hypoglycemia, but with a measured PGC>70 mg/dL. Only categories with values are presented.|Upto Month 12|ITT population. Data has been presented for number of participants with their percentages with hypoglycemic events defined by hypoglycemic event categories from Baseline upto month 12.||Participants|||Count of Participants
765579|NCT00678886|Secondary|Number of Hypoglycemic Events Defined by Hypoglycemic Event Categories From Baseline Upto Month 12|Hypoglycemic events reported by participants were classified as defined by the American Diabetes Association (ADA) Workgroup on Hypoglycemia as follows: Severe hypoglycemia: an event requiring assistance of another person to actively administer carbohydrate, glucagon/other resuscitative actions, documented symptomatic hypoglycemia: an event during which typical symptoms of hypoglycemia are accompanied by a measured plasma glucose concentration(PGC)<=70 mg/dL, asymptomatic hypoglycemia: an event not accompanied by typical symptoms of hypoglycemia but with a measured PGC<=70 mg/dL,probable symptomatic hypoglycemia: an event during which symptoms of hypoglycemia are not accompanied by a plasma glucose determination, but were presumably caused by a PGC<=70 mg/dL and relative hypoglycemia: an event during which the person with diabetes reports any of the typical symptoms of hypoglycemia, and interprets the symptoms as indicative of hypoglycemia, but with a measured PGC>70 mg/dL.|Upto Month 12|ITT population.||Hypoglycemic events|||Number
765580|NCT00678886|Secondary|HbA1c Level at Week 12 and Months 6 and 12|HbA1c levels were recorded at Screening, Baseline (Day 1), Day 28, Week 8, Week 12, Months 4 to 12 and Month 24. Data has been presented for HbA1c levels at Week 12 and Months 6 and 12.|Week 12 and Months 6 and 12|ITT population.||Percentage||Standard Error|Least Squares Mean
765581|NCT00678886|Secondary|Mean Daily Insulin Use at Week 12 and Months 6 and 12.|Participants recorded their daily insulin use in their electronic diaries. In particular, insulin was recorded thoroughly and accurately for at least 7 consecutive days during the 2 weeks before the visits at Baseline, Week 12, and Months 6 and 12. During each of these visits, the investigator/designee accessed the invivodata DiaryPRO web site to review insulin-use data for the previous 2-week period to ensure completeness. If errors/gaps were identified (e.g., if the participant did not take insulin and not entered 0 units), the investigator/designee recorded the missing data from participant recall using a data clarification form (DCF). Paper diary to collect insulin use, were reviewed for completeness. Any missing data that could be recalled by the participant was entered. If the participant did not record any insulin use during the 2-week period before the visit, the site obtained an insulin use history for the previous 7 days and calculated the average daily insulin dose.|Week 12 and Months 6 and 12.|ITT population.||IU/kg||Standard Error|Least Squares Mean
765582|NCT00678886|Secondary|Number of Participants Who Were Responders for (Glycosylated Hemoglobin) HbA1c/Insulin Use Response at Week 12 and Months 6 and 12|A participant was considered a responder if, at the given time point, the participant had HbA1c<= 6.5%, and mean daily insulin use over 7 consecutive days < 0.5 international units per kilogram per day (IU/kg/day) during the 2 weeks preceding the visit. Data has been presented from number of participants with their percentages who were responders at Week 12 and Months 6 and 12.|Week 12 and Months 6 and 12|ITT population. Only those participants available at the specified time points were analyzed.||Participants|||Count of Participants
765583|NCT00678886|Primary|Change From Baseline in 2-hour Mixed Meal Stimulated C-peptide Area Under Curve [AUC] (Normalized for 120-minute Time Interval) at Month 12|Mixed meal-stimulated C-peptide AUC was the area under the C-peptide/time curve from Time 0 to 120 minutes, calculated using the trapezoidal rule. This reported AUC was normalized for time interval by dividing it by 120 minutes. This normalized AUC was calculated for each participant at Baseline, Week 12, and at Months 6, 12, 18, and 24. Data has been presented for meal stimulated C-peptide Area under assessment performed at Month 12. Baseline assessments were carried out on the morning of Day 1, before the start of the first infusion of study drug. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at Month 12.|Baseline (0-120 minutes on Day 1) and Month 12 (0-120 minutes)|Intent-to-treat (ITT) population, comprised of all participants who were randomized and received any part of at least 1 infusion of study drug.||nanomoles per liter||Standard Error|Least Squares Mean
765584|NCT00678899|Secondary|AzBio Sentence Score-Treated Ear|"Secondary efficacy endpoints using binomial comparisons (based on the postoperative Hybrid condition) are as follows:
The AzBio Sentence Test consists of 15 lists of 20 sentences each. AzBio sentences are spoken by different talkers in a conversational style with limited contextual cues that the listener can use to predict or 'fill in'unintelligible words. Each list includes 5 sentences from 4 different male and female speakers. Each word in the sentence counts toward the overall score. The percentage of subjects that scored equal to or better than they did in the pre-operative acoustic only condition will be reported."|6 Months Postactivation|||percentage of subjects|||Number
765586|NCT00678899|Primary|AzBio Sentence Score in Noise - Treated Ear (Co-Primary)|"The co-primary study endpoints will be statistically significant differences between the mean, preoperative AzBio Sentences score in noise (unilateral acoustic, ear to be implanted) and postoperative AzBio Sentences score in noise (Hybrid mode) for the activated, Hybrid L24 cochlear implant subjects.
The AzBio Sentence Test consists of 15 lists of 20 sentences each. AzBio sentences are spoken by different talkers in a conversational style with limited contextual cues that the listener can use to predict or 'fill in' unintelligible words. Each list includes 5 sentences from 4 different male and female speakers. Each word in the sentence counts towards the overall score."|6 Months Postactivation|||percentage of words correct||Standard Deviation|Mean
765587|NCT00678899|Primary|Consonant Nucleus Consonant (CNC) Monosyllabic Word Score-Treated Ear (CO-PRIMARY)|"The co-primary study endpoints will be statistically significant differences between the mean, preoperative monosyllabic CNC word score (unilateral acoustic, ear to be implanted) and the postoperative monosyllabic CNC word scores (Hybrid mode) for the activated, Hybrid L24 cochlear implant subjects.
The CNC Words test consists of 10 recorded lists of 50 monosyllabic words in CD format. For this study, two lists will be administered in quiet at a level equal to 60 dBA in the sound field and scored as a total number of words correct, which will be expressed as a percentage correct for this study."|6 Months Postactivation|||percentage of words correct||Standard Deviation|Mean
765588|NCT00679055|Secondary|Number of Participants Who Were Discontinued From the Study Due to an Adverse Event (AE)|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the study drug. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an AE. The percentage of participants who were discontinued from the study due to an AE was summarized.|up to 14 weeks|All enrolled participants who received at least one dose of study drug.||Particpants|||Number
765589|NCT00679055|Secondary|Change From Baseline in Messenger Ribonucleic Acid (mRNA)|mRNA is a biomarker associated with the inflammatory response. Blood samples were taken to determine the level of mRNA present at baseline (predose Day 1) and again after 12 weeks of study drug administration in participants with peripheral arterial disease of the lower extremity who are scheduled for excision of an atherosclerotic plaque.|Baseline and Week 12|Study terminated early. Planned analyses was not performed.|||||
765590|NCT00679055|Primary|Change From Baseline in Cluster of Differentiation 68 (CD68)|CD68 is a heavily glycosylated transmembrane protein resident to macrophage lysosomes, and is the standard immunohistochemical (IHC) marker for macrophages in human tissues. CD68 protein content as a measure of macrophage number is the most often reported marker in clinical studies of plaque instability. Blood samples were taken to determine the level of CD69 present at baseline (predose Day 1) and again after 12 weeks of study drug administration in participants with peripheral arterial disease of the lower extremity who are scheduled for excision of an atherosclerotic plaque.|Baseline and Week 12|Study terminated early. Planned analyses was not performed.|||||
765591|NCT00679081|Secondary|Subject Preference Measures||6-months||||||
765592|NCT00679081|Secondary|Post-Surgical Subject Comfort Measures||4-weeks||||||
765593|NCT00679081|Secondary|Aesthetic Measures||6-months||||||
765594|NCT00679081|Secondary|Periodontal Health Measures||6-months||||||
765595|NCT00679081|Primary|Overall Rate of Adverse Events (AEs)|"Adverse events were collected at every visit throughout the 6 month duration.
An AE is defined as any adverse change in the subject's medical status when compared with the subject's baseline condition, whether or not the event is related to the study device or a study procedure; or an exacerbation (either in frequency or severity) in a subject's pre-existing condition."|6-month|||participants|||Number
765596|NCT00679172|Secondary|Number and Proportion of Subjects Developing an Immune Response at the Target Dose of 7.5 x 10^9 CFU (Cohort 2) as Determined by the Fold Change in IgG.|Number and proportion of subjects with 4-fold increase for serum IgG on Day 28 compared to baseline (assay using endpoint titre ELISA).|From baseline (pre-dose) to Day 28.|ITT Population (Cohort 2): all subjects who received study medication and had any postbaseline immunogenicity data available up to and including Day 28.||Participants|||Count of Participants
765597|NCT00679172|Secondary|Number and Proportion of Subjects Developing an Immune Response at the Target Dose of 7.5 x 10^9 CFU (Cohort 2) as Determined by the Number of ASCs Secreting IgA.|Number and proportion of subjects with ≥ 4 ASCs per 10^6 PBMCs at Day 7 secreting IgA specific for S. typhi LPS (detected by ELISPOT).|Day 7.|ITT Population (Cohort 2): all subjects who received study medication and had any postbaseline immunogenicity data available up to and including Day 28.||Participants|||Count of Participants
765598|NCT00679172|Secondary|Number and Proportion of Subjects Developing an Immune Response at the Target Dose of 7.5 x 10^9 CFU (Cohort 2) as Determined by the Number of Antibody Secreting Cells (ASCs) Secreting IgA and/or Fold Change in IgG.|Number and proportion of subjects with ≥ 4 ASCs per 10^6 peripheral blood mononuclear cells (PBMCs) at Day 7 secreting IgA specific for S. typhi LPS (detected by enzyme-linked immunospot assay [ELISPOT]) AND/OR 4-fold increase for serum IgG on Day 28 compared to baseline (assay using endpoint titre ELISA).|At Day 7 (IgA); and from baseline (pre-dose) to Day 28 (IgG).|ITT Population (Cohort 2): all subjects who received study medication and had any postbaseline immunogenicity data available up to and including Day 28.||Participants|||Count of Participants
765599|NCT00679172|Secondary|Number and Proportion of Subjects Developing an Immune Response as Determined by the Level of IgG Antibodies for S. Typhi LPS.|Number and proportion of subjects with an increase of 70% (fold change of 1.7) in S. typhi LPS-specific serum IgG at Days 7, 14 or 28. Serum IgG was assayed using ELISA.|From baseline (pre-dose) to Days 7, 14, or 28.|ITT Population: all subjects who received study medication and had any postbaseline immunogenicity data available up to and including Day 14.||Participants|||Count of Participants
765600|NCT00679172|Secondary|Number and Proportion of Subjects Developing an Immune Response as Determined by the Level of IgG Antibodies for S. Typhi LPS.|Number and proportion of subjects with increase of 70% (fold change of 1.7) in S. typhi LPS-specific serum IgG at Days 14 or 28. Serum IgG was assayed using ELISA.|From baseline (pre-dose) to Days 14 or 28.|ITT Population: all subjects who received study medication and had any postbaseline immunogenicity data available up to and including Day 28.||Participants|||Count of Participants
770369|NCT00711009|Secondary|Mean Change From Baseline in Adiponectin (Micrograms/Milliliter)|Included in measures of metabolic toxicity|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||micrograms/milliliter||Standard Deviation|Mean
765601|NCT00679172|Secondary|Number and Proportion of Subjects Developing an Immune Response as Determined by the Level of IgA Antibodies for S. Typhi LPS.|Number and proportion of subjects with increase of 50% (fold change of 1.5) in S. typhi LPS-specific serum IgA at Days 7 or 14. Serum IgA was assayed using ELISA.|From baseline (pre-dose) to Days 7 or 14.|ITT Population: all subjects who received study medication and had any postbaseline immunogenicity data available up to and including Day 28.||Participants|||Count of Participants
765602|NCT00679172|Primary|Number and Proportion of Subjects Developing an Immune Response as Determined by the Level of IgG and/or IgA Antibodies for S. Typhi Lipopolysaccharide (LPS).|Number and proportion of subjects with increase of 70% (fold change of 1.7) in S. typhi LPS-specific serum IgG at Days 14 or 28 AND/OR increase of 50% (fold change of 1.5) in S. typhi LPS-specific serum IgA at Days 7 or 14. Serum IgG and IgA were assayed using enzyme-linked immunosorbent assay (ELISA).|From baseline (pre-dose) to Days 14 or 28 (IgG) or to Days 7 or 14 (IgA).|ITT Population: all subjects who received study medication and had any postbaseline immunogenicity data available up to and including Day 28.||Participants|||Count of Participants
765603|NCT00679172|Primary|Number of Subjects Having Shedding in Stool of Salmonella Typhi (S. Typhi) (Ty2 aroC‾ssaV‾) ZH9.|Number of subjects having shedding in stool of S. typhi (Ty2 aroC‾ssaV‾) ZH9. Subjects were evaluated beyond Day 14 only in Cohort 4.|Beyond 7 days post-dosing through 14 days post-dosing (Cohorts 1-3) or through 21 days post-dosing (Cohort 4).|Safety Population: All subjects who received a dose of study medication.||participants|||Number
765604|NCT00679172|Primary|Number and Proportion of Subjects Experiencing Bacteraemia.|Number and proportion of subjects experiencing a proven bacteraemia attributed to the vaccine strain S. typhi (Ty2 aroC‾ssaV‾) ZH9.|From start of dosing to 28 days post-dosing.|Safety Population: All subjects who received a dose of study medication.||Participants|||Count of Participants
765605|NCT00679172|Primary|Number of Subjects Reporting Treatment-related TEAEs.|"Number of subjects having TEAEs considered by the principal investigator to be possibly or probably related to treatment."|From start of dosing to 28 days post-dosing.|Safety Population: All subjects who received a dose of study medication.||participants|||Number
765606|NCT00679172|Primary|Number of Subjects Having Clinically Significant Changes in Laboratory Test Parameters.|Number of subjects having clinically significant changes in clinical laboratory test parameters.|From start of dosing to 28 days post-dosing.|Safety Population: All subjects who received a dose of study medication.||participants|||Number
765607|NCT00679172|Primary|Number and Proportion of Subjects Experiencing Symptomatic Fever.|Number and proportion of subjects experiencing symptomatic (e.g., chills, rigors, sweating, headache, myalgia etc.) elevated body temperature of 38.0°C or more in the 14 days following dosing.|From start of dosing to 14 days post-dosing.|Safety Population: All subjects who received a dose of study medication.||Participants|||Count of Participants
765608|NCT00679172|Primary|Number and Proportion of Subjects Reporting Suspected Unexpected Serious Adverse Reactions.|Number and proportion of subjects reporting suspected unexpected serious adverse reactions (SUSARs).|From start of dosing to 28 days post-dosing.|Safety Population: All subjects who received a dose of study medication.||Participants|||Count of Participants
765609|NCT00679211|Secondary|Percentage of Participants With Clinical Benefit Based on Investigator Assessment|Clinical benefit was defined as participants with an objective response (confirmed complete or partial response) or stable disease at 6 months. Patients with stable disease at 6 months were defined as patients who achieved at least stable disease based on tumor assessments and remained alive and progression free at 6 months. Response was based on the Investigator's assessment.|From randomization until 1 January 2010, approximately 9 months after the last participant was enrolled.|Treated population. Patients without a post-baseline tumor assessment were considered to have experienced no clinical benefit.||percentage of participants||95% Confidence Interval|Number
765610|NCT00679211|Secondary|Duration of Objective Response Based on Investigator Assessment|"For participants who achieved an objective response, duration of objective response was defined as the time from the first tumor assessment that supported a participant's objective response to the time of disease progression or death on study (i.e., death from any cause within 30 days of the last dose of study drug), whichever occurred first. Response was determined by the Investigator's assessment.
Disease progression was at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions or the appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions.
For participants who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate the duration of objective response."|From randomization until 1 January 2010, approximately 9 months after the last participant was enrolled.|Participants with an objective response.||months||95% Confidence Interval|Median
765611|NCT00679211|Secondary|Progression-free Survival Based on Investigator Assessment|"Progression-Free Survival (PFS) was defined as the time from the first day of study treatment to documented disease progression or death on study (i.e., death from any cause within 30 days of the last dose of study drug), whichever occurred first.
Disease progression was at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions or the appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions.
For patients who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate PFS."|From randomization until 1 January 2010, approximately 9 months after the last participant was enrolled.|Treated population||months||95% Confidence Interval|Median
765622|NCT00673387|Secondary|Mean Change From Screening to Week 28 in Electrocardiogram Parameters - Intent to Treat Population|A 12-Lead electrocardiogram (ECG) was obtained at Screening, Day 1, Weeks 1, 12, 28 (study termination). The PR interval, which is time from beginning of the P wave to the beginning of the QRS complex (Note: QRS complex is a name for the combination of 3 of the graphical deflections seen in an ECG); QRS interval (time from the beginning to the end of the QRS complex); QT interval (measure between Q wave and T wave in the heart's electrical cycle); and QT interval corrected for heart rate using Fridericia's formula (QTcF) were measured in milliseconds (msec).|Screening to Week 28 (or study termination)|Intent to treat population included all randomized participants who received at least one injection of study medication.||msec||Standard Deviation|Mean
765612|NCT00679211|Secondary|Objective Response Based on Investigator Assessment|"Objective response was defined as a complete response (CR) or partial response (PR) determined on two consecutive occasions ≥ 4 weeks apart, assessed using Response Evaluation Criteria in Solid Tumors (RECIST). Response was assessed by the study Investigator.
CR: the disappearance of all target lesions and all nontarget lesions and normalization of tumor marker level and no new lesions.
PR: disappearance of all target lesions and persistence of ≥ 1 nontarget lesion(s) and/or the maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of the longest diameter of target lesions, and no new lesions or unequivocal progression of existing nontarget lesions."|From randomization until 1 January 2010, approximately 9 months after the last participant was enrolled.|Treated population. Participants without a post-baseline tumor assessment were considered to be non-responders.||percentage of participants||95% Confidence Interval|Number
765613|NCT00679211|Secondary|Percentage of Participants With Clinical Benefit Based on Independent Radiologic Review|"Clinical benefit was defined as participants who achieved an objective response (confirmed complete or partial response) between randomization and 1 January 2010, or with stable disease at 6 months. Stable disease at 6 months was defined as participants who achieved at least stable disease based on tumor assessments by the independent review facility, and remained alive and progression-free at 6 months.
Stable disease was defined as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started, and no new lesions and/or unequivocal progression of existing nontarget lesions. Response was assessed by the independent review facility."|From randomization until 1 January 2010, approximately 9 months after the last participant was enrolled.|Treated population. Participants without a post-baseline tumor assessment were considered to have experienced no clinical benefit.||percentage of participants||95% Confidence Interval|Number
765614|NCT00679211|Secondary|Progression-free Survival as Assessed Through Independent Radiologic Review|"Progression-Free Survival (PFS) was defined as the time from the first day of study treatment to documented disease progression or death on study (i.e., death from any cause within 30 days of the last dose of study drug), whichever occurred first.
Disease progression was at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions or the appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions. Disease progression was assessed by the independent review facility.
For patients who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate PFS."|From randomization until 1 January 2010, approximately 9 months after the last participant was enrolled.|Treated population.||months||95% Confidence Interval|Median
765615|NCT00679211|Secondary|Duration of Objective Response as Assessed Through Independent Radiologic Review|"For participants who achieved an objective response, duration of objective response was defined as the time from the first tumor assessment that supported a participant’s objective response to the time of disease progression or death on study (i.e., death from any cause within 30 days of the last dose of study drug), whichever occurred first. Response was assessed by the independent review facility.
Disease progression was at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions or the appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions.
For participants who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate the duration of objective response."|From randomization until 1 January 2010, approximately 9 months after the last participant was enrolled.|Participants with an objective response.||months||95% Confidence Interval|Median
765616|NCT00679211|Primary|Percentage of Participants With an Objective Response as Assessed Through Independent Radiologic Review|"Objective response was defined as a complete response (CR) or partial response (PR) determined on two consecutive occasions ≥ 4 weeks apart, assessed using Response Evaluation Criteria in Solid Tumors (RECIST).
CR: the disappearance of all target lesions and all nontarget lesions and normalization of tumor marker level and no new lesions.
PR: disappearance of all target lesions and persistence of ≥ 1 nontarget lesion(s) and/or the maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of the longest diameter of target lesions, and no new lesions or unequivocal progression of existing nontarget lesions.
The primary data cut-off date was 17 September 2009 (approximately 6 months after the last patient was enrolled). The final efficacy analysis was performed using a data cut-off date of 1 January 2010 (approximately 9 months after the last patient was enrolled)."|From randomization until the primary analysis data cut-off date of September 2009 (6 months after last patient enrolled) and until the final efficacy analysis cut-off date of 1 January 2010 (approximately 9 months after the last patient enrolled).|Treated population (patients who received at least one dose of T-DM1). Participants without a post-baseline tumor assessment were considered to be non-responders.||percentage of participants||95% Confidence Interval|Number
765617|NCT00679263|Secondary|FEV1 Percent Predicted Changes From Base Line|The primary efficacy variable will be the change from baseline in FEV1, expressed as percent of predicted at hour 1 after the start of the infusion. Analysis of all other variables at all other time points will be considered secondary.|Day 1 to Day 2|||FEV1 percent predicted||Standard Deviation|Mean
765618|NCT00679263|Primary|Number of Patients Reported to Have Adverse Events||Day 1 to Day 2|||participants|||Number
765619|NCT00673361|Secondary|Response Rate as Determined by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria||post-cycle 1 of low-dose temozolomide plus sorafenib, then every 3 months for up to 2 years||||||
765620|NCT00673361|Primary|Progression Free Survival (PFS)|Terminated study before accrual goal, no data analysis|3 weeks, 6 weeks, 16 weeks, & 24 weeks||||||
765621|NCT00673387|Secondary|Mean Change From Screening to Week 28 in the Electrocardiogram Parameter of Heart Rate - Intent to Treat Population|A 12-Lead electrocardiogram (ECG) was obtained at Screening (visit 2), Day 1, Weeks 1, 12, 28 (study termination). Heart Rate was measured in beats per min (bpm).|Screening to Week 28 (or early termination)|Intent to treat population included all randomized participants who received at least one injection of study medication.||bpm||Standard Deviation|Mean
770370|NCT00711009|Secondary|Mean Change From Baseline in Magnesium (Millimoles/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||millimoles/liter||Standard Deviation|Mean
765623|NCT00673387|Secondary|Number of Participants With Treatment-emergent Positive Anti-leptin Antibody Titers at Week 28 - Intent to Treat Population|Baseline refers to Day 1. If Day 1 value was missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 was used. Serum titer determinations for antibodies to metreleptin were made using a validated electrochemical luminescence (ECLA) bridging assay. Antibody titers were assessed according to the following dilutions: 0, 5, 25, 125, 625, 3125, 15625, and 78125. Participants were considered to have a positive titer to treatment-emergent antibodies to metreleptin at a given visit if they had a titer >=5 following a negative or missing titer at baseline or if they had a titer that had increased by at least 2 dilutions from a detectable level at baseline.|Baseline to Week 28|Intent to treat population included all randomized participants who received at least one injection of study medication.||participants|||Number
765624|NCT00673387|Secondary|Mean Change in Heart Rate From Baseline to Week 28 - Intent to Treat Population|Baseline refers to Day 1. If Day 1 value was missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 was used. Heart rate was measured while the participant was sitting and was measured in beats per minute (bpm). Values obtained at Screening, Day -7, Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28.|Baseline to Week 28|Intent to treat population included all randomized participants who received at least one injection of study medication.||bpm||Standard Deviation|Mean
765625|NCT00673387|Secondary|Mean Change in Systolic and Diastolic Blood Pressure From Baseline to Week 28 - Intent to Treat Population|Baseline refers to Day 1. If Day 1 value was missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 was used. Blood pressure was taken while the participant was sitting and was measured in millimeters of mercury (mm Hg). Values obtained at Screening, Day -7, Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28|Baseline to Week 28|Intent to treat population included all randomized participants who received at least one injection of study medication.||mm Hg||Standard Deviation|Mean
765626|NCT00673387|Secondary|Number of Chemistry Laboratory Values of Potential Clinical Importance Observed From Screening to Week 28 - Intent to Treat Population|Obtained at: Screening, Days -7, 1, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28. Numbers of laboratory values are cumulative across the study. Criteria for values of potential clinical importance for obese and overweight (BMI>=25 kg/m^2) participants: Total bilirubin High (H) > 2 mg/dL; Plasma/serum glucose fasting or non-fasting H > 200 mg/dL, low (L) < 60 mg/dL; Albumin L <2.5 g/dL; Creatine kinase H > 3*Upper limit of Normal (ULN); Sodium L <130 milliequivalents per liter (mEq/L), H > 150 mEq/L; potassium L<3.0 mEq/L, H> 5.5 mEq/L;bicarbonate L<18 mEq/L, H>35 mEq/L;calcium L <8mg/dL, H> 11 mg/dL; triglycerides H> 500 mg/dL; Cholesterol L < 100 mg/dL, H > 350 mg/dL; Alkaline phosphatase H > 3*ULN; Gamma-glutamyltransferase H>3*ULN; creatinine males > 1.6 mg/dL, females > 1.4 mg/dL; alanine aminotransferase H > 3*ULN; aspartate aminotransferase H > 3*ULN; urea nitrogen H > 45 mg/dL; uric acid males > 10.0 mg/dL, females > 8.0 mg/dL; Phosphorus L < 1.0 mg/dL H > 6.0 mg/dL.|Screening to Week 28|Intent to treat population included all randomized participants who received at least one injection of study medication.||Number of Laboratory Values|||Number
765627|NCT00673387|Secondary|Number of Hematology and Urinalysis Laboratory Values of Potential Clinical Importance Observed From Screening to Week 28 - Intent to Treat Population|Criteria for laboratory values of potential clinical importance for obese and overweight (BMI >= 25 kg/m^2) participants: Platelets high (H) >500,000/µL; low (L) <75,000/µL. Hematocrit males <36%, females <30%. Hemoglobin males <12 g/dL, females <10 g/dL. White blood cell count (WBC) H >18,000/µL; L <1,500/µL. Urine protein H >= 3+ or >= 500 mg/dL. Urine glucose H >= 3+ or >= 500 mg/dL. Urine ketones >= 3+ or Large. Values obtained at Screening, Day -7, Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28. Numbers of values are cumulative across the study.|Screening to Week 28|Intent to treat population included all randomized participants who received at least one injection of study medication.||Number of Laboratory Values|||Number
765628|NCT00673387|Secondary|Mean Absolute Change From Screening to Week 24 in the Epworth Sleepiness Scale (ESS) Total Score - Evaluable Population|The Epworth Sleepiness Scale (ESS) is an eight-item questionnaire that assesses sleep propensity in daily situations of increasing sleepiness on a four-point scale with 0=would never doze and 3=high chance of dozing. Lower scores indicate improvement. Values were obtained for this questionnaire on Visit 3 in the screening period|Screening to Week 24|Evaluable population includes participants received at least one dose of randomized treatment, had adequate exposure to treatment, and complied with the protocol as assessed prior to database lock and unblinding. Missing item responses may be imputed for each subject as appropriate before summarization.||units on a scale||Standard Error|Mean
765629|NCT00673387|Secondary|Mean Absolute Change From Screening to Week 24 in Minutes to Fall Asleep, Hours of Sleep and The Pittsburgh Sleep Quality Index (PSQI) Global Score - Evaluable Population|The Pittsburgh Sleep Quality Index (PSQI) is a questionnaire which assesses sleep quality and sleep disturbances over a period of 1 month. The PSQI provides ratings on seven domains of sleep (subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction). The sum of the individual domains yields a global sleep quality score with a range of 0-21. A PSQI score >5 is indicative of poor sleep, which is characterized by severe difficulties in at least two domains, or moderate difficulties in three or more domains. Values were obtained for this questionnaire on Visit 3 in the screening period.|Screening to Week 24|Evaluable population includes participants received at least one dose of randomized treatment, had adequate exposure to treatment, and complied with the protocol as assessed prior to database lock and unblinding. Missing item responses may be imputed for each subject as appropriate before summarization.||units on a scale||Standard Deviation|Mean
765637|NCT00673387|Secondary|LS Mean Absolute Change From Baseline to Week 28 in Fat-free Mass (kg) - Evaluable Population|Parameters of body composition were measured with a Dual Energy X-ray Absorptiometry (DEXA) scan. Data from the first valid DEXA scan obtained no later than 7 days after the first randomized dose was considered as valid baseline values; data from the last valid DEXA scan obtained no later than 10 days after last clinical visit or no later than 14 days after last dose of randomized study medication was considered as valid study termination values. Fat-free mass were measured in kilogram (k).|Baseline to Week 28|Evaluable population includes participants received at least one dose of randomized treatment, had adequate exposure to treatment, and complied with the protocol as assessed prior to database lock and unblinding. Number analyzed (n) were of evaluable participants with valid DEXA scan at Week 28.||kg||Standard Error|Least Squares Mean
765630|NCT00673387|Secondary|Mean Absolute Change From Screening to Week 24 in Summary Scores for Profile of Mood States - Brief (POMS-B) - Evaluable Population|The POMS is a mood scale consisting of 65 mood adjectives that assess participants’ mood over the past seven days. The POMS-B is an authorized, 30-item brief version of the POMS consisting of five items for each of the six POMS factors. The mood adjectives load onto 6 mood factors, which are as follows: Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment. Scores range from 0= Not at All to 4=Extremely. The factor scores are added to obtain the total mood disturbance score. A lower total mood disturbance score indicates improvement. Values were obtained for this questionnaire on Visit 3 in the screening period.|Screening to Week 24|Evaluable population includes participants received at least one dose of randomized treatment, had adequate exposure to treatment, and complied with the protocol as assessed prior to database lock and unblinding. Missing item responses may be imputed for each subject as appropriate before summarization.||units on a scale||Standard Error|Mean
765631|NCT00673387|Secondary|Mean Absolute Change From Screening to Week 24 in Hospital Anxiety and Depression Scale (HADS) Total Scores - Evaluable Population|The HADS is a questionnaire that uses 14 items to assess both anxiety and depression over the past week. The odd numbered items constitute the anxiety subscale, and the even numbered items constitute the depression subscale. The individual response scores for each subscale component are added together to obtain the individual subscale scores. The minimum and maximum score for each subscale is 0 and 21, respectively. The higher the score, the worse the outcome. Values were obtained for this questionnaire on Visit 3 in the screening period|Screening to Week 24|Evaluable population includes participants received at least one dose of randomized treatment, had adequate exposure to treatment, and complied with the protocol as assessed prior to database lock and unblinding. Missing item responses may be imputed for each subject as appropriate before summarization.||units on a scale||Standard Error|Mean
765632|NCT00673387|Secondary|Mean Absolute Change From Screening to Week 24 in Susceptibility to Eating Questionnaire (SEQ) Item Scores - Evaluable Population|The eating questionnaire is an exploratory measure of appetite, satiety, and perceived control over portion size using 10 VAS items with each response measured on a 100 mm visual analogue scale (ranges vary from Never to Very Often; Not at All Difficult to Extremely Difficult; Not at all Strong to Very Strong). Lower scores indicate improvement. The Eating Questionnaire instructed participants to rate their responses to these items over the past 7 days. Values were obtained for this questionnaire on Visit 3 in the screening period.|Screening to Week 24|Evaluable population includes participants received at least one dose of randomized treatment, had adequate exposure to treatment, and complied with the protocol as assessed prior to database lock and unblinding. Missing item responses may be imputed for each subject as appropriate before summarization.||units on a scale||Standard Deviation|Mean
765633|NCT00673387|Secondary|Mean Absolute Change From Screening to Week 24 in Binge Eating Scale (BES) Total Score - Evaluable Population|The Binge Eating Scale (BES) is a 16-item questionnaire that assesses the behavioral and cognitive correlates of binge eating, including participants’ perceived self-control over eating behavior using a range of 1 to 4 with 1=positive perceptions and 4= negative perceptions. The minimum and maximum score for the BES instrument is 0 and 55, respectively. The higher the score the worse the outcome. Values were obtained for this questionnaire on Visit 3 in the screening period.|Screening to Week 24|Evaluable population includes participants received at least one dose of randomized treatment, had adequate exposure to treatment, and complied with the protocol as assessed prior to database lock and unblinding. Missing item responses may be imputed for each subject as appropriate before summarization.||units on a scale||Standard Deviation|Mean
765634|NCT00673387|Secondary|Mean Absolute Change From Screening to Week 24 in Impact of Weight on Quality of Life Questionnaire-lite Version (IWQOL-Lite) Total Score - Evaluable Population|Subjective effects of weight loss were measured using the IWQOL-Lite questionnaire, a 31-item patient reported outcome (PRO) instrument used to assess the effect of weight on physical function, self-esteem, sexual life, public distress, and work. Individual items have a range of 1 to 5 with 5=always true and 1= never true. The total score for the IWQOL-Lite instrument is measured on a scale from 0 (worst) to 100 (best). Higher scores indicate improvement. Values were obtained for this questionnaire on Visit 3 in the screening period.|Screening to Week 24|Evaluable population includes participants received at least one dose of randomized treatment, had adequate exposure to treatment, and complied with the protocol as assessed prior to database lock and unblinding. Missing item responses may be imputed for each subject as appropriate before summarization.||units on a scale||Standard Deviation|Mean
765635|NCT00673387|Secondary|Mean Absolute Change From Baseline to Week 28 for Insulin - Evaluable Population|Baseline refers to Visit 5 (Day 1). If Day 1 value is missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 is used. Fasting samples were obtained at baseline, Weeks 4, 12, and 28. Parameter was measured micro international units per milliliter. (µIU/mL).|Baseline to Week 28|Evaluable population includes participants received at least one dose of randomized treatment, had adequate exposure to treatment, and complied with the protocol as assessed prior to database lock and unblinding.||µIU/mL||Standard Error|Least Squares Mean
765636|NCT00673387|Secondary|LS Mean Absolute Change From Baseline to Week 28 in Fasting Plasma Glucose, Total Cholesterol (TC), Triglycerides, Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL) Cholesterol - Evaluable Population|Baseline refers to Visit 5 (Day 1). If Day 1 value is missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 is used. Fasting samples were obtained at baseline, Weeks 4, 12, and 28. All parameters were measured in milligrams per deciliter (mg/dL).|Baseline to Week 28|Evaluable population: received at least one dose of randomized treatment, had adequate exposure to treatment, complied with the protocol as assessed prior to database lock and unblinding. Number analyzed (n) presented above for TC, LDL and HDL cholesterol. Glucose n= 43, 50, 41, 46, 45, 43,44,36; Triglycerides n= 44,50,41,46,45,44,44.38.||mg/dL||Standard Error|Least Squares Mean
765646|NCT00673387|Secondary|Number of Participants Achieving at Least 5% and at Least 10% Body Weight Loss From Baseline to Week 28 - Evaluable Population|Baseline refers to Day 1. If Day 1 value is missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 is used.|Baseline to Week 28|Evaluable population includes all intent to treat participants (received at least one dose of randomized treatment) who had adequate exposure to treatment and complied with the protocol as assessed prior to database lock and unblinding.||participants|||Number
765638|NCT00673387|Secondary|LS Mean Absolute Change From Baseline to Week 28 in Total Body Fat Mass (k) - Evaluable Population|Parameters of body composition were measured with a Dual Energy X-ray absorptiometry (DEXA) scan. Data from the first valid DEXA scan obtained no later than 7 days after the first randomized dose was considered as valid baseline values; data from the last valid DEXA scan obtained no later than 10 days after last clinical visit or no later than 14 days after last dose of randomized study medication was considered as valid study termination values. Body fat mass was measured in kilogram (k).|Baseline to Week 28|Evaluable population includes participants received at least one dose of randomized treatment, had adequate exposure to treatment, and complied with the protocol as assessed prior to database lock and unblinding. Number analyzed (n) were of evaluable participants with valid DEXA scan at Week 28.||kg||Standard Error|Least Squares Mean
765639|NCT00673387|Secondary|Least Squares (LS) Mean Absolute Change From Baseline to Week 28 in Percent of Body Fat - Evaluable Population|Parameters of body composition were measured with a Dual Energy X-ray absorptiometry (DEXA) scan and reported as a percent (%). Data from the first valid DEXA scan obtained no later than 7 days after the first randomized dose was considered as valid baseline values; data from the last valid DEXA scan obtained no later than 10 days after last clinical visit or no later than 14 days after last dose of randomized study medication was considered as valid study termination values. Absolute change from baseline was defined as percent body fat at Week 28 - percent body fat at baseline.|Baseline to Week 28|Evaluable population includes participants received at least one dose of randomized treatment, had adequate exposure to treatment, and complied with the protocol as assessed prior to database lock and unblinding. Number analyzed (n) were of evaluable participants with valid DEXA scan at Week 28.||percentage of body fat||Standard Error|Least Squares Mean
765640|NCT00673387|Secondary|Geometric Mean of the Maximum Observed Plasma Concentration (Cmax) for Pramlintide at Weeks 4 and 24 - Evaluable Population Receiving Pramlintide|Assessment of Cmax was over a period of 2 hours following pramlintide administration at Weeks 4 and 24. Cmax was measured as picograms/milliliter (pg/mL).|Week 4 and Week 24|Evaluable population: participants received at least one dose of randomized treatment, had adequate exposure to treatment and complied with the protocol as assessed prior to database lock and unblinding. Number (n) analyzed at Week 4 n=46,40,41,40,40,33 in each arm, respectively; Week 24 n=48,38, 44,40,35,36 in each arm, respectively.||pg/mL||Standard Error|Geometric Mean
765641|NCT00673387|Secondary|Geometric Mean of AUC From Time 0 to Infinity for Pramlintide at Weeks 4 and 24 - Evaluable Population Treated With Pramlintide|Assessment of AUC was over a period of 2 hours following pramlintide administration. Area under the concentration curve (AUC) time 0 to infinity (-inf). For AUC calculations, concentration at -5 min will be considered as 0 h concentration if quantifiable. AUC measured in picograms*hour/milliliter (pg*h/mL).|Weeks 4 and 24|Evaluable population: participants received at least one dose of randomized treatment, had adequate exposure to treatment and complied with the protocol as assessed prior to database lock and unblinding. Number (n) analyzed at Week 4: n=39,36,37,36,35,31 in each arm, respectively; Week 24 n=46, 35, 42, 39, 33, 35 in each arm, respectively.||pg*h/mL||Standard Error|Geometric Mean
765642|NCT00673387|Secondary|Geometric Mean of the Total Area Under the Concentration Time Curve (AUC) From Time 0 to Last Quantifiable Concentration (Tlast) for Pramlintide at Weeks 4 and 24 - Evaluable Population Receiving Pramlintide|Assessment of AUC was over a period of 2 hours following pramlintide administration. AUC (0 to time of last quantifiable concentration (-tlast). For AUC calculation, concentration at -5 min will be considered as 0 h concentration if quantifiable, otherwise, t=0 h. AUC measured as picograms*hour/milliliter (pg*h/mL). Pramlintide concentrations measured using a colorimetric immunoenzymetric assay employing monoclonal antibodies against pramlintide for both capture and detection.|Week 4 and Week 24|Evaluable population: participants received at least one dose of randomized treatment, had adequate exposure to treatment and complied with the protocol as assessed prior to database lock and unblinding. Number (n) analyzed at Week 4:n=46, 40,41, 40,40,33 in each arm respectively;Week 24:n=48, 38, 44, 40, 35, 36.||pg*h/mL||Standard Error|Geometric Mean
765643|NCT00673387|Secondary|LS Mean Change in Waist Circumference From Baseline to Week 12 and Week 28 - Evaluable Population|Waist circumference was measured at baseline (Day 1), Weeks 12, 28 (or at early termination) in centimeters (cm).|Baseline to Weeks 12 and Week 28|Participants who received at least 1 dose of randomized treatment and who had adequate exposure to treatment and complied with the protocol as assessed prior to database lock/unblinding. Numbers (n) analyzed Week 12 n=45,51,41,47,45,45,45,38 in each treatment group respectively; Week 28 n= 44, 51, 41, 46, 45, 44, 43, 38 in each group, respectively.||cm||Standard Error|Least Squares Mean
765644|NCT00673387|Secondary|LS Mean Absolute Change in Body Weight From Baseline to Weeks 4, 12, and 28 - Evaluable Population|Least Squares (LS) mean absolute change in Body weight was measured in kilograms (kg). Baseline is defined as Day 1. If Day 1 was missing or after the first dose date of randomized treatment, the last available value prior to Day 1 was used.|Baseline to Week 28|Evaluable population includes all intent to treat participants (received at least one dose of randomized treatment) who had adequate exposure to treatment and complied with the protocol as assessed prior to database lock and unblinding.||kg||95% Confidence Interval|Least Squares Mean
765645|NCT00673387|Secondary|Mean Absolute Change From Baseline to Weeks 4, 12, 28 in Mean Trough Concentration of Total Leptin - Evaluable Population|Mean fasting plasma total leptin concentration (nanograms per milliliter; ng/mL) change from baseline over time by pooled metreleptin dose (sex, baseline BMI category, and baseline value). Baseline defined as Day 1. If Day 1 value is missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 is used. Evaluable population: all participants who received at least one dose of randomized treatment, had adequate exposure to treatment and complied with the protocol as assessed prior to database lock and unblinding. Leptin concentrations measured using a validated immunoenzymetric assay utilizing polyclonal capture antibody, monoclonal detection antibody, and colorimetric readout by Amylin Pharmaceuticals, Inc.|Baseline to Week 28|Number analyzed (n) at baseline above. Week 4: n=41 45,46, 45, 45, 38; Week 8: n=41,45,46,44,45,37; Week 12: n=41, 46, 46, 45,45,38; Week 16: n=41,47,46,45,45,38; Week 20: n=41, 45,45,45,45,38; Week 24: n=40, 43, 46, 42, 44,38; Week 28: n=41, 45, 45, 44, 43, 36. Leptin concentration for placebo and pramlintide plus placebo groups not presented.||ng/mL||Standard Deviation|Mean
765707|NCT00679354|Secondary|Time to Death (TTD)|The distribution of TTD will be analyzed separately using PL estimate.|Time from study enrollment to death from any cause, assessed up to 5 years||||||
765647|NCT00673387|Primary|Least Squares (LS) Mean Percent Change in Body Weight From Baseline to Week 28 - Evaluable Population|Body weight was measured in kilogram (kg). Baseline is defined as Day 1. If Day 1 was missing or after the first dose date of randomized treatment, the last available value prior to Day 1 was used. Drug Randomization stratified by sex and 3 categories baseline BMI (12 arms); 3 treatment arms combined for summaries as single placebo treatment group; 3 combined for summaries as single pramlintide monotherapy treatment group (total: 8 treatment groups).|Baseline to Week 28|Evaluable population includes all intent to treat participants (received at least one dose of randomized treatment) who had adequate exposure to treatment and complied with the protocol as assessed prior to database lock and unblinding.||Percentage change in kg||95% Confidence Interval|Least Squares Mean
765648|NCT00673400|Other Pre-specified|SF36 Component Summary Scores|"Quality of life short form 36 version 2(SF36v2) standard form
PCS: physical component summary score (range 1 to 81, with 81 being the best) MCS: mental component summary score (range -9 to 82, with 82 being the best)
A score of 50 correlates with the result of a healthy standard US population (score transformation to a mean of 50 and a standard deviation of 10)
Ware JE, Kosinski M, Dewey JE. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: QualityMetric Incorporated, 2000."|Before surgery - 6 months|||units on a scale||Inter-Quartile Range|Median
765649|NCT00673400|Other Pre-specified|Obstructive Defecation Syndrome Score|"Score based on severity or frequency of 9 symptoms of obstructive defecation (physician administered)
(0 - 40, no symptoms = 0)
Dis Colon Rectum 51:348(DOI: 10.1007/s10350-007-9115-1)"|before surgery - 6 weeks -3 months - 6 months|||units on a scale||Inter-Quartile Range|Median
765650|NCT00673400|Other Pre-specified|Severity of Symptoms Score|"Score based on the severity of 9 symptoms of bowel movement (physician administered)
(0 - 36, no symptoms = 0)
Dis Colon Rectum 39:681 (DOI: 10.1007/BF02056950)"|before surgery - 6 weeks - 3 months - 6 months|||units on a scale||Inter-Quartile Range|Median
765651|NCT00673400|Secondary|Hospitalization|Length of hospital stay (Date of release - Date of admission + 1)|1 day to 1 year (until release from hospital)|||days||Full Range|Median
765652|NCT00673400|Secondary|Morbidity|Surgical complications after treatment according to Dindo (Ann Surg (2004) 240:205)|1 year|||participants|||Number
765653|NCT00673400|Primary|Quality of Life|"Quality of life is measured by Fecal incontinence quality of life (FIQL)
Possible range of score 0 - 4 (Depression/Self perception 4.4)
0 = worst condition
Fecal Incontinence Quality of Life (FIQL) (Rockwood, Dis Colon Rectum (2000) 43:9)"|6 months after intervention|Participating in the FIQL survey was voluntarily. Some patients did not participate at all, some did not answer all questions. Patients answering >=50% of questions of a domain were counted as participants||units on a scale||Inter-Quartile Range|Median
765654|NCT00673439|Secondary|the Incidence of Venous or Thrombotic Events After Starting Treatment With Fondaparinux||4 weeks after INR reaches 2 or more||||||
765655|NCT00673439|Primary|the Incidence of Clinically Significant Bleeding, Defined as Hemodynamically Significant Bleeding or Requiring Blood Transfusions While Being Treated With Fondaparinux|Study terminated, results data not available|at fondaparinux discontinuation||||||
765656|NCT00673452|Secondary|Change From Baseline in Weight at 12 Week Endpoint||Baseline, 12 weeks|Number of patients with a baseline and at least one post-baseline result.||kilograms (kg)||Standard Error|Least Squares Mean
765657|NCT00673452|Secondary|Number of Patients With Columbia Suicide Severity Rating Scale (CSSR-S) Events (Behaviors, Ideations, Acts)|"C-SSRS: scale capturing occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of patients with suicidal behaviors, ideations, and acts are provided. Suicidal behavior: a “yes” answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a “yes” answer to any one of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation. Suicidal act: a yes answer to actual attempt or completed suicide."|Baseline through 12 Weeks|Number of randomized patients.||participants|||Number
765658|NCT00673452|Secondary|Change From Baseline in Heart Rate at 12 Week Endpoint||Baseline, 12 weeks|Number of patients with a baseline and at least one post-baseline result.||beats per minute (bpm)||Standard Error|Least Squares Mean
765659|NCT00673452|Secondary|Change From Baseline in Blood Pressure at 12 Week Endpoint||Baseline, 12 weeks|Number of patients with a baseline and at least one post-baseline result.||mm Hg||Standard Error|Least Squares Mean
765660|NCT00673452|Secondary|Number of Responders: 50% Improvement in Brief Pain Inventory Average Pain Score at 12 Week Endpoint|Response was defined as at least 50% reduction from baseline to endpoint (last observation carried forward) for BPI average pain score. BPI average pain score assesses the severity of the average pain in the past 24 hours. The average severity score ranges from 0 (no pain) to 10 (pain as bad as you can imagine).|12 weeks|Number of randomized patients with baseline and at least one post-baseline data.||participants|||Number
765661|NCT00673452|Secondary|Number of Responders: 30% Improvement in Brief Pain Inventory Average Pain at 12 Week Endpoint|Response was defined as at least 30% reduction from baseline to endpoint (last observation carried forward) for BPI average pain score. BPI average pain score assesses the severity of the average pain in the past 24 hours. The average severity score ranges from 0 (no pain) to 10 (pain as bad as you can imagine).|12 Weeks|Number of randomized patients with baseline and at least one post-baseline data.||participants|||Number
765662|NCT00673452|Secondary|Change From Baseline in the Mood, Anxiety, Pain, Sleep, and Stiffness Likert Scale at 12 Week Endpoint|Likert scales are patient-rated assessments. Mood: feeling low, sad or depressed; rated 0 = not feeling low, sad or depressed to 10 = feeling extremely low, sad or depressed. Anxious: anxious feelings; rated 0 = not feeling anxious to 10 = extremely anxious. Sleep: how much patient bothered by sleep difficulties; rated 0 = not bothered to 10 = extremely bothered. Pain: how much patient bothered by painful physical discomforts; rated 0 = not bothered to 10 = extremely bothered. Stiffness: how stiff patient felt in past 24 hours; rated 0 = not felt any stiffness to 10 = felt extremely stiff.|Baseline, 12 weeks|Number of patients with a non-missing baseline and at least one post-baseline record.||units on a scale||Standard Error|Least Squares Mean
765708|NCT00679354|Secondary|Time to Treatment Failure (TTF)|The distributions of TTF will be analyzed separately using PL estimate.|Time from study enrollment to tumor progression, tumor recurrence, death from any cause, or occurrence of a second malignant neoplasm, assessed up to 5 years||||||
775174|NCT00754624|Primary|Annual Rate of Change in FEV1 From Baseline to End of Study||Baseline to 48 months|Safety Population defined as all subjects who received at least one dose of study drug||Liters per year||Standard Error|Mean
765663|NCT00673452|Secondary|Change From Baseline in Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH-CPFQ) Total Score at 12 Week Endpoint|"The MGH-CPFQ is a self-report instrument consisting of seven questions pertaining to an individual's cognitive and physical well-being. Each question is rated 1 = greater than normal to 6 = totally absent. Total score ranges from 7 to 42."|Baseline, 12 weeks|Number of patients with a non-missing baseline and at least one post-baseline record.||units on a scale||Standard Error|Least Squares Mean
765664|NCT00673452|Secondary|Change From Baseline in 36-Item Short-form Health Survey (SF-36) at 12 Weeks|The patient-rated SF-36 consists of 36 questions covering eight health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function, and vitality. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. Two summary scores: the Physical Component Summary and the Mental Component Summary are constructed based on the eight SF-36 domains.|Baseline, 12 weeks|Number of patients with a non-missing baseline and at least one post-baseline record.||units on a scale||Standard Error|Least Squares Mean
765665|NCT00673452|Secondary|Change From Baseline in Beck Anxiety Inventory (BAI) at 12 Week Endpoint|BAI is a 21-item patient-completed questionnaire designed to assess characteristics of anxiety. Each item is rated on a 4-point scale (0 = not present; 3 = present in the extreme). This questionnaire will be used to rate the severity of anxiety symptoms and any improvement during the course of the trial. The total score ranges from 0 to 63; the higher the score, the more severe the anxiety symptoms.|Baseline, 12 weeks|Number of patients with a non-missing baseline and at least one post-baseline record.||units on a scale||Standard Error|Least Squares Mean
765666|NCT00673452|Secondary|Change From Baseline in Clinical Global Impressions of Severity (CGI-S) at 12 Week Endpoint|The Clinical Global Impressions of Severity (CGI-Severity) scale evaluates the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Baseline, 12 Weeks|Number of patients with a non-missing baseline and at least one post-baseline record.||units on a scale||Standard Error|Least Squares Mean
765667|NCT00673452|Secondary|Change From Baseline in Beck Depression Inventory-II (BDI-II) at 12 Week Endpoint|BDI-II is a 21-item patient-completed questionnaire designed to assess characteristics of depression. Each item is rated on a 4-point scale (0 = not present; 3 = present in the extreme). This questionnaire will be used to rate the severity of depressive symptoms and any improvement during the course of the trial. The total score ranges from 0 to 63; the higher the score, the more severe the depressive symptoms.|Baseline, 12 weeks|Number of patients with a non-missing baseline and at least one post-baseline record.||units on a scale||Standard Error|Least Squares Mean
765668|NCT00673452|Secondary|Change From Baseline in Multidimensional Fatigue Inventory (MFI) at 12 Week Endpoint|MFI is a 20-item, self-reporting instrument designed to collect data on the following 5 dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. Each dimension score is derived by summing the scores of the 4 individual items that pertain to each dimension. Item scores range from 1 to 5; thus, dimensional scores range from 4 to 20 with a higher score reflecting greater levels of fatigue.|Baseline, 12 weeks|Number of patients with a non-missing baseline and at least one post-baseline record.||units on a scale||Standard Error|Least Squares Mean
765669|NCT00673452|Secondary|Change From Baseline in Brief Pain Inventory (BPI) (Modified Short Form) at 12 Week Endpoint|BPI is a self-reported form that assesses severity of pain and the interference of pain on function. There are 4 questions assessing the severity for worst pain, least pain, and average pain in the past 24 hours, and the pain right now. Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine). There are 7 questions assessing the interference of pain in the past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline, 12 weeks|Number of patients with a non-missing baseline and at least one post-baseline record. Last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
765670|NCT00673452|Primary|Patient's Global Impressions of Improvement (PGI-I) at Week 12|The PGI-Improvement scale is a patient-rated instrument that measures perceived improvement in symptoms. It is a 7-point scale where a score of 1 indicates that the patient is “very much improved,” a score of 4 indicates that the patient has experienced “no change,” and a score of 7 indicates that the patient is “very much worse.”|12 weeks|Number of randomized patients with baseline PGI-S and at least one post-baseline PGI-I data.||units on a scale||Standard Error|Least Squares Mean
765671|NCT00673465|Secondary|Pharmacokinetic: Mean Plasma Tmax (Part 2 - India)|Blood samples for SCH 497079 pharmacokinetics will be collected at pre-dose/0-hour on Day 1 (Period 1 only) and pre-dose Day 14 and pre-dose/0-hour and at 0.5, 1, 2, 6, 12, and 24 hours post study drug administration (not breakfast) on Day 28 of the placebo and SCH 497079 periods only. In addition to these time points, a sample for metformin level will also be collected pre-dose on Day 1, Day 14, and Day 28 of the metformin administration period only.|Pre-dose (0 hour), 0.5, 1, 2, 6, 12, and 24 hours after administration of study drug|No participants were randomized to treatment during Part 2 of the study.|||||
765672|NCT00673465|Secondary|Pharmacokinetic: Mean Time to Maximum Observed Plasma Concentration (Tmax) (Part 1 - United States)|Blood samples for SCH 497079 pharmacokinetics will be collected at pre-dose/0-hour on Day 1 (Period 1 only) and pre-dose Day 14 and pre-dose/0-hour and at 0.5, 1, 2, 6, 12, and 24 hours post study drug administration (not breakfast) on Day 28 of the placebo and SCH 497079 periods only. In addition to these time points, a sample for metformin level will also be collected pre-dose on Day 1, Day 14, and Day 28 of the metformin administration period only.|Pre-dose (0 hour), 0.5, 1, 2, 6, 12, and 24 hours after administration of study drug|No efficacy summary or analysis was completed for this outcome measure since the Part 1 objective was not met (i.e., to determine the 24-hour glycemic profile of T2DM participants after four weeks of treatment with SCH 497079 vs. placebo).|||||
765673|NCT00673465|Secondary|Pharmacokinetic: Mean Plasma Cmax (Part 2 - India)|Blood samples for SCH 497079 pharmacokinetics will be collected at pre-dose/0-hour on Day 1 (Period 1 only) and pre-dose Day 14 and pre-dose/0-hour and at 0.5, 1, 2, 6, 12, and 24 hours post study drug administration (not breakfast) on Day 28 of the placebo and SCH 497079 periods only. In addition to these time points, a sample for metformin level will also be collected pre-dose on Day 1, Day 14, and Day 28 of the metformin administration period only.|Pre-dose (0 hour), 0.5, 1, 2, 6, 12, and 24 hours after administration of study drug|No participants were randomized to treatment during Part 2 of the study.|||||
765674|NCT00673465|Secondary|Pharmacokinetic: Mean Maximum Observed Plasma Concentration (Cmax) (Part 1 - United States)|Blood samples for SCH 497079 pharmacokinetics will be collected at pre-dose/0-hour on Day 1 (Period 1 only) and pre-dose Day 14 and pre-dose/0-hour and at 0.5, 1, 2, 6, 12, and 24 hours post study drug administration (not breakfast) on Day 28 of the placebo and SCH 497079 periods only. In addition to these time points, a sample for metformin level will also be collected pre-dose on Day 1, Day 14, and Day 28 of the metformin administration period only.|Pre-dose (0 hour), 0.5, 1, 2, 6, 12, and 24 hours after administration of study drug|No efficacy summary or analysis was completed for this outcome measure since the Part 1 objective was not met (i.e., to determine the 24-hour glycemic profile of T2DM participants after four weeks of treatment with SCH 497079 vs. placebo).|||||
765675|NCT00673465|Secondary|Pharmacokinetic: Mean Plasma Glucose (Over 24 Hours) at Week 4 (Part 2 - India)|Blood samples for SCH 497079 pharmacokinetics will be collected at pre-dose/0-hour on Day 1 (Period 1 only) and pre-dose Day 14 and pre-dose/0-hour and at 0.5, 1, 2, 6, 12, and 24 hours post study drug administration (not breakfast) on Day 28 of the placebo and SCH 497079 periods only. In addition to these time points, a sample for metformin level will also be collected pre-dose on Day 1, Day 14, and Day 28 of the metformin administration period only.|Pre-dose (0 hour), 0.5, 1, 2, 6, 12, and 24 hours after administration of study drug|No participants were randomized to treatment during Part 2 of the study.|||||
765676|NCT00673465|Secondary|Pharmacokinetic: Mean Plasma Glucose (Over 24 Hours) at Week 4 (Part 1 - United States)|Blood samples for SCH 497079 pharmacokinetics will be collected at pre-dose/0-hour on Day 1 (Period 1 only) and pre-dose Day 14 and pre-dose/0-hour and at 0.5, 1, 2, 6, 12, and 24 hours post study drug administration (not breakfast) on Day 28 of the placebo and SCH 497079 periods only. In addition to these time points, a sample for metformin level will also be collected pre-dose on Day 1, Day 14, and Day 28 of the metformin administration period only.|Pre-dose (0 hour), 0.5, 1, 2, 6, 12, and 24 hours after administration of study drug|No efficacy summary or analysis was completed for this outcome measure since the Part 1 objective was not met (i.e., to determine the 24-hour glycemic profile of type 2 diabetes mellitus [T2DM] participants after four weeks of treatment with SCH 497079 vs. placebo).|||||
765677|NCT00673465|Secondary|Pharmacodynamic: Change From Baseline in Plasma Glucose During the 12-hour Post Absorptive State (AUC/Duration) at Week 4 (Part 2 - India)|The post absorptive state is defined as the remaining part of day and night that is not the postprandial period. The postprandial period is defined as the sum of 4 hours after breakfast, 4 hours after lunch and 4 hours after dinner for a total of 12 hours. AUC/duration is presented as mg/dL and was calculated by dividing AUC (mg/dL*hr) by the duration in hours. Model-based least squares mean: ANOVA extracting the effects due to treatment, sequence, period and participant.|Baseline and Week 4|No participants were randomized to treatment during Part 2 of the study.|||||
765678|NCT00673465|Secondary|Pharmacodynamic: Change From Baseline in Plasma Glucose During the 12-hour Post Absorptive State (AUC/Duration) at Week 4 (Part 1 - United States)|The post absorptive state is defined as the remaining part of day and night that is not the postprandial period. The postprandial period is defined as the sum of 4 hours after breakfast, 4 hours after lunch and 4 hours after dinner for a total of 12 hours. AUC/duration is presented as mg/dL and was calculated by dividing AUC (mg/dL*hr) by the duration in hours. Model-based least squares mean: ANOVA extracting the effects due to treatment, sequence, period and participant.|Baseline and Week 4|All participants who completed study treatment with at least SCH 497079 and placebo.||mg/dL||Standard Error|Least Squares Mean
765679|NCT00673465|Secondary|Pharmacodynamic: Change From Baseline in 12-hour Postprandial Plasma Glucose (AUC/Duration) at Week 4 (Part 2 - India)|The postprandial period is defined as the sum of 4 hours after breakfast, 4 hours after lunch and 4 hours after dinner for a total of 12 hours. AUC/duration is presented as mg/dL and was calculated by dividing AUC (mg/dL*hr) by the duration in hours. Model-based least squares mean: ANOVA extracting the effects due to treatment, sequence, period and participant.|Pre-dose (-30 minutes), pre-standard breakfast (0 hour), 0.5, .75, 1, 2, 3, 4, 4.5, 4.75, 5, 6, 7, 8, 9, 9.5, 9.75, 10, 11, 12, 13, 14, 15, 16, and 24 hours after the beginning of the standardized breakfast on Day -1 and Day 28|No participants were randomized to treatment during Part 2 of the study.|||||
765680|NCT00673465|Secondary|Pharmacodynamic: Change From Baseline in 12-hour Postprandial Plasma Glucose (AUC/Duration) at Week 4 (Part 1 - United States)|The postprandial period is defined as the sum of 4 hours after breakfast, 4 hours after lunch and 4 hours after dinner for a total of 12 hours. AUC/duration is presented as mg/dL and was calculated by dividing AUC (mg/dL*hr) by the duration in hours. Model-based least squares mean: ANOVA extracting the effects due to treatment, sequence, period and participant.|Pre-dose (-30 minutes), pre-standard breakfast (0 hour), 0.5, .75, 1, 2, 3, 4, 4.5, 4.75, 5, 6, 7, 8, 9, 9.5, 9.75, 10, 11, 12, 13, 14, 15, 16, and 24 hours after the beginning of the standardized breakfast on Day -1 and Day 28|All participants who completed study treatment with at least SCH 497079 and placebo.||mg/dL||Standard Error|Least Squares Mean
765681|NCT00673465|Secondary|Number of Participants Who Experienced at Least One Adverse Event (Part 2 - India)|An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment. AEs may include the onset of new illness and the exacerbation of pre-existing conditions.|Up to 14 days after last dose of study drug (up to 98 days)|No participants were randomized to treatment during Part 2 of the study.|||||
765682|NCT00673465|Secondary|Number of Participants Who Experienced at Least One Adverse Event (Part 1 - United States)|An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment. AEs may include the onset of new illness and the exacerbation of pre-existing conditions.|Up to 14 days after last dose of study drug (up to 98 days)|All randomized participants.||Participants|||Number
765709|NCT00679354|Secondary|Time to Tumor Progression (TTP)|The distributions of TTP will be analyzed separately using product limit (PL) estimate.|Time from study enrollment to radiographically determined tumor progression or recurrence, assessed up to 5 years||||||
765710|NCT00679354|Primary|Objective Response to Cilengitide|Objective response is defined as a complete response or partial response at 4 weeks that is sustained for at least another 4 weeks, or a stable disease at 4 weeks that is sustained for at least 12 weeks while on stable or decreasing dose of corticosteroids, except when corticosteroids are being used to control hydrocephaly unrelated to tumor progression.|Up to 16 weeks|Six patients are considered inevaluable for objective response (including one ineligible patient) and excluded from analysis.||participants|||Number
765683|NCT00673465|Primary|Pharmacodynamic: Change From Baseline in 24-hour Plasma Glucose (AUC/Duration) at Week 4 (Part 2 - India)|Change from baseline in 24-hour plasma glucose on the last day of treatment. On the day of the glucose collections (and the day prior to), standardized meals (breakfast, lunch, dinner, and snack) were provided and consumed over 15 minutes. AUC/duration is presented as mg/dL and was calculated by dividing AUC (mg/dL*hr) by the duration in hours. Model-based least squares mean: ANOVA extracting the effects due to treatment, sequence, period and participant.|Pre-dose (-30 mnutes), pre-standard breakfast (0 hour), 0.5, .75, 1, 2, 3, 4, 4.5, 4.75, 5, 6, 7, 8, 9, 9.5, 9.75, 10, 11, 12, 13, 14, 15, 16, and 24 hours after the beginning of the standardized breakfast on Day -1 and Day 28|No participants were randomized to treatment during Part 2 of the study.|||||
765684|NCT00673465|Primary|Pharmacodynamic: Change From Baseline in Mean 24-hour Plasma Glucose (AUC/Duration) at Week 4 (Part 1 - United States)|Change from baseline in 24-hour plasma glucose on the last day of treatment. On the day of the glucose collections (and the day prior to), standardized meals breakfast, lunch, dinner, and snack) were provided and consumed over 15 minutes. AUC/duration is presented as mg/dL and was calculated by dividing AUC (mg/dL*hr) by the duration in hours. Model-based least squares mean: ANOVA extracting the effects due to treatment, sequence, period and participant.|Pre-dose (-30 minutes), pre-standard breakfast (0 hour), 0.5, .75, 1, 2, 3, 4, 4.5, 4.75, 5, 6, 7, 8, 9, 9.5, 9.75, 10, 11, 12, 13, 14, 15, 16, and 24 hours after the beginning of the standardized breakfast on Day -1 and Day 28|All participants who completed study treatment with at least SCH 497079 and placebo.||mg/dL||Standard Error|Least Squares Mean
765685|NCT00673595|Secondary|24-hour Ambulatory Blood Pressure|Ambulatory blood pressure will be measured using the Spacelabs 90202 recorder. Systolic and diastolic blood pressure during the 24-hour period will be analyzed.|2 weeks after participants quit smoking (study visit 3, day 15)|This study was terminated early due to difficulty with recruiting subjects and with subjects complying with the protocol; analysis was not performed.||mm Hg||Standard Deviation|Mean
765686|NCT00673595|Primary|Arterial Endothelial Function as Measured by Flow-mediated Dilation|Flow-mediated dilation of the brachial artery will be measured using high-resolution ultrasound. Arterial diameter will be measured above the small cavity in the elbow joint from ultrasound images at rest in response to an increase in blood flow to the area. This blood flow will be induced by inflation of a blood pressure cuff placed around the forearm to a pressure of at least 50 mm Hg above systolic pressure for 5 min, followed by release. The ultrasound image of the artery will be recorded continuously from 30 sec before until 2 min after cuff release.|2 weeks after participants quit smoking (study visit 3, day 15)|This study was terminated early due to difficulty with recruiting subjects and with subjects complying with the protocol; analysis was not performed.||mm||Standard Deviation|Mean
765687|NCT00673660|Secondary|Number of Participants With Reasons of Non-compliance to Statin Treatment|Participants were called for a final visit and reasons for non-compliance were recorded.|Month 12|Primary analysis population, subset of evaluable participants||participants|||Number
765688|NCT00673660|Secondary|Number of Participants With Reasons of Compliance to Statin Treatment|Compliance with medication use defined as not skipping or forgeting dosing or not delaying the dosing time at least 80 percent (%) of the days in which the medication was used. Participants were called for a final visit . Compliance with drug dosage was recorded.|Month 12|Primary analysis population. The number of participants with reasons of compliance to statin treatment were not collected or analyzed.||participants|||Number
765689|NCT00673660|Secondary|Available Lipid Profiles of Compliant and Non-compliant Participants|Available laboratory measurements of participants were recorded in CRFs.|Month 12|Primary analysis population, subset of evaluable participants.||milligrams per deciliter||Standard Deviation|Mean
765690|NCT00673660|Primary|Percentage of Participants Who Were Compliant With Statin Treatment|The physician asked participants about their compliance with medication use, which was defined as not skipping or forgetting dosing or not delaying the dosing time at least 80 percent (%) of the days in which the medication was used.|Month 12|Primary analysis population: participants diagnosed with dyslipidemia who were taking or planning to take statin treatment. Subset of evaluable participants were analyzed.||Percentage of participants|||Number
765691|NCT00673673|Secondary|Overall Survival||Upon completion of study, up to 3 years|||months||95% Confidence Interval|Median
765692|NCT00673673|Secondary|Overall Tumor Response Rate by RECIST Criteria|"Per response evaulation criteria in solid tumors criteria (RECIST) for target lesions assessed by FDG-PET Scans: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR., or similar definition that is accurate and appropriate."|Upon completion of study|||percentage of participants|||Number
765693|NCT00673673|Primary|Progression Free Survival||Upon completion of study, up to 3 years|||months||95% Confidence Interval|Median
765694|NCT00679302|Secondary|New Lesion Development and Spread of Skin Abscesses|The secondary outcomes of interest included the development of new lesions at a different site (>5cm away from original skin abscess) on day 10 clinical follow-up or self-report and 3 month telephone follow-up.|10-14 days and 3 month|||participants|||Number
765695|NCT00679302|Primary|Skin Abscess Resolution||10-14 days|||participants||95% Confidence Interval|Number
765696|NCT00679341|Secondary|Plasma Concentration of Free Emtansine|Plasma samples were collected from all 67 patients in the trastuzumab emtansine group 30 minutes post-infusion of trastuzumab emtansine at Cycles 1 and 5. The plasma samples were assayed for free emtansine in a mass-spectrometric assay.|Baseline through Cycle 5 (up to 4 months)|Pharmacokinetic evaluable population: Patients who had adequate concentration-time data to estimate at least 1 pharmacokinetic parameter.||ng/mL||Standard Deviation|Mean
765697|NCT00679341|Secondary|Serum Concentrations (Area Under the Concentration-time Curve [AUC]) of Trastuzumab Emtansine and Total Trastuzumab|Serum samples were collected from all 67 patients enrolled in the trastuzumab emtansine arm using sparse pharmacokinetic sampling. Blood samples were collected prior to dosing and 30 minutes post-infusion of trastuzumab emtansine at Cycles 1 and 5. Serum samples were assayed for trastuzumab emtansine and total trastuzumab (sum of unconjugated trastuzumab and emtansine conjugated to trastuzumab) in indirect sandwich ELISAs. The area under the concentration-time curve (AUC) was estimated based on non-compartmental analysis using WinNonlin (Version 5.2.1) software.|Baseline through Cycle 5 (up to 4 months)|Pharmacokinetic evaluable population: Patients who had adequate concentration-time data to estimate at least 1 pharmacokinetic parameter.||day•μg/mL||Standard Deviation|Mean
765698|NCT00679341|Secondary|Time to Symptom Progression|Time to symptom progression was defined as the time from randomization to the first documentation of a ≥ 5-point decrease from baseline in the Trial Outcome Index-Physical/Functional/Breast (TOI-PFB) subscale score of the Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire. The FACT-B questionnaire is a valid and reliable measure of symptoms associated with breast cancer. The TOI-PFB is a 24-item subscale generated using 3 subsections (Physical Well-Being [7 items], Functional Well-Being [7 items], and Additional Concerns [10 items]) from the FACT-B questionnaire. Patients responded to each item on a scale of 0-4 (Not at all-Very much). The total score ranged from 0 to 96. A higher score indicates fewer symptoms. A positive change score indicates improvement.|Baseline through the data cut-off date of 15 Nov 2010 (up to 2 years, 2 months)|All randomized patients with a Baseline and at least 1 post-Baseline valid score.||Months||95% Confidence Interval|Median
765699|NCT00679341|Secondary|Clinical Benefit (CB) Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)|CB was defined as an objective response (complete response [CR], partial response [PR]) or stable disease (SD) for 6 months after randomization. For target lesions (TL), CR=the disappearance of all TL; PR=at least a 30% decrease in the sum of the longest diameter (LD) of TL, taking as reference the baseline sum LD; SD=neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started; PD=at least a 20% increase in the sum of the LD of TL, taking as reference the smallest sum of the LD recorded since the treatment started or the appearance of 1 or more new lesions. For non-TL, CR=the disappearance of all non-TL; PR=the persistence of 1 or more non-TL; SD=the persistence of 1 or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits; PD=the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TL.|Baseline through the data cut-off date of 15 Nov 2010 (up to 2 years, 2 months)|All randomized patients with measurable disease at Baseline.||Percentage of patients||90% Confidence Interval|Number
765700|NCT00679341|Secondary|Duration of Objective Response Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)|Duration of objective response was defined as the time from initial response to investigator-assessed radiographic or clinical disease progression or death on study from any cause. For target lesions, disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, disease progression was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Target lesions should be selected on the basis of their size (those with the longest diameter) and their suitability for accurate repeated measurements by imaging techniques or clinically. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions.|Baseline through the data cut-off date of 15 Nov 2010 (up to 2 years, 2 months)|All randomized patients with measureable disease at Baseline. Only patients with an objective response were included in the analysis.||Months||95% Confidence Interval|Median
765701|NCT00679341|Secondary|Objective Response Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)|A patient had an objective response if they had a complete response or a partial response on 2 consecutive occasions ≥ 4 weeks apart. For target lesions, a complete response was defined as the disappearance of all target lesions; a partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. For non-target lesions, a complete response was defined as the disappearance of all non-target lesions; a partial response was defined as the persistence of 1 or more non-target lesions.|Baseline through the data cut-off date of 15 Nov 2010 (up to 2 years, 2 months)|All randomized patients with measureable disease at Baseline.||Percentage of patients||90% Confidence Interval|Number
765702|NCT00679341|Secondary|Overall Survival|Overall survival was defined as the time from randomization to the date of death from any cause. Patients who were alive at the time of analysis were censored at the date on which they were last known to be alive. Patients with no post-baseline were censored at the date of randomization plus 1 day.|Baseline through the data cut-off date of 31 Aug 2011 (up to 2 years, 11 months)|Intent-to-treat population: All randomized patients.||Months||95% Confidence Interval|Median
765703|NCT00679341|Primary|Progression-free Survival (PFS) by the Investigator Using Modified Response Evaluation Criteria In Solid Tumors (RECIST)|PFS was defined as the time from randomization (R) to first documented investigator-assessed radiographic or clinical disease progression (PD) or death due to any cause, whichever occurred first. For target lesions (TL), PD was defined as at least a 20% increase in the sum of the longest diameter (SLD) of TLs, taking as reference the SLD recorded since treatment started or the appearance of 1 or more new lesions. For non-TLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. Data for patients without PD or death were censored at the last date of tumor assessment prior to crossover (or, if no tumor assessment was performed after Baseline, at the R date +1 day). Data for patients who were lost to follow-up were censored at the last date of tumor assessment prior to crossover at which the patient was known to be progression free. Data for patients with no post-baseline tumor assessment were censored at the R date +1 day.|Baseline through the data cut-off date of 15 Nov 2010 (up to 2 years, 2 months)|Intent-to-treat population: All randomized patients.||Months||95% Confidence Interval|Median
765704|NCT00679354|Other Pre-specified|Pharmacogenetic Polymorphisms in Drug Transporters and Relate to Cilengitide Disposition|Cilengitide systemic exposure as measured by AUC and systemic clearance as the pharmacologic variable in this genotype-phenotype analysis will be used.|At baseline||||||
765705|NCT00679354|Secondary|Pharmacokinetics of Cilengitide in Plasma, Including of the Central Compartment (Vc), Elimination Rate Constant (Ke), and Half-life (t1/2), and Systemic Clearance (Cl)|Cilengitide plasma concentration-time data will be fit to a compartmental pharmacokinetic model using MAP-Bayesian estimation as implemented in ADAPT II. Cl will be calculated using standard equations and area under the curve (AUC)0-o∞ will be calculated using the log-linear trapezoidal method.|At baseline and 1, 3, and 6 hours after the first dose of cilengitide||||||
765706|NCT00679354|Secondary|Rate of Toxicity, Especially That of Symptomatic Intratumoral Hemorrhage (ITH) Assessed by Common Terminology Criteria for Adverse Events Version 4.0|Rates of individual toxicities including that of symptomatic ITH will be summarized in each course of treatment using standard descriptive statistical methods.|Up to 5 years||||||
765712|NCT00679367|Secondary|Number of Organs Improved or Stable Based on Description Below:|"Renal response - > 50% decrease in daily 24 hour proteinuria, without worsening renal insufficiency.
Hepatic response - decrease of 2 centimeters or more of the liver span and/or decrease of the alkaline phosphatase by 50% if elevated at baseline.
Cardiac response - decrease of 2 millimeters or more in mean left ventricular wall thickness in patients with baseline wall thickness > 11 mm or a decrease in New York Heart Association heart failure class.
Autonomic nervous system response - resolution of orthostatic vital signs and symptoms, and resolution of symptoms of gastric atony or of functional ileus.
Gastrointestinal response - a greater than one grade improvement in diarrhea due to biopsy proven amyloid.
Peripheral nervous system response – resolution of clinical signs of peripheral neuropathy."|one year|||number of organs stable or improved|involved organs||Number
765713|NCT00679367|Primary|Number of Participants With Hematologic Response|"Complete hematologic response: Absence of detectable monoclonal protein in serum or urine by immunofixation electrophoresis, bone marrow biopsy with less than 5% plasma cells without clonal dominance of kappa or lambda isotype, and normal serum free light chain assay.
Partial hematologic response: Amyloid patients have highly individualized measures of disease burden. For patients with detectable and quantifiable monoclonal marrow plasmacytosis, a reduction of 50% or more in plasma cells as a percentage of nucleated bone marrow cells. For patients with a detectable monoclonal peak on serum or urine protein electrophoresis, a reduction in the peak height of 50% or more. For patients with quantifiable urinary kappa or lambda chain concentration, a 50% reduction in daily light chain excretion (concentration x 24 hour urine volume). For patients with an elevated serum free light chain assay, reduction of 50% or more."|one year|Participants who completed at least 3 cycles of treatment||participants|||Number
765714|NCT00679380|Secondary|Endoscopic Improvement.|"Greater or equal to a 1 point improvement in the mucosal appearance subscore of the UCDAI, from baseline to week 8.
As per the hierarchical testing procedure for secondary endpoints, because clinical improvement was not statistically significant in the ITT population, formal statistical comparisons for endoscopic improvement between the 2 budesonide MMX groups and placebo were not conducted."|8 weeks|Efficacy endpoints were analyzed with the ITT population, defined as randomized patients who received study drug, had no entry criteria/GCP violation, and had abnormal mucosal histology at baseline. ITT population=410 patients: 511 - 101 patients who were not randomized, had entry criteria/GCP violation, or had normal histology at baseline.||percentage of patients||95% Confidence Interval|Number
765715|NCT00679380|Secondary|Clinical Improvement.|Clinical improvement, defined as a ≥ 3-point improvement in UCDAI from baseline to the end of Week 8.|8 weeks|Efficacy endpoints were analyzed with the ITT population, defined as randomized patients who received study drug, had no entry criteria/GCP violation, and had abnormal mucosal histology at baseline. ITT population=410 patients: 511 - 101 patients who were not randomized, had entry criteria/GCP violation, or had normal histology at baseline.||percentage of patients||95% Confidence Interval|Number
765716|NCT00679380|Primary|Clinical and Endoscopic Remission.|Clinical and endoscopic remission defined as an Ulcerative Colitis Disease Activity Index (UCDAI) score ≤ 1, with subscores of 0 for rectal bleeding, stool frequency, and mucosal appearance and with a ≥ 1 point reduction in the endoscopic index score.|8 weeks|Efficacy endpoints were analyzed with the ITT population, defined as randomized patients who received study drug, had no entry criteria/GCP violation, and had abnormal mucosal histology at baseline. ITT population=410 patients: 511 - 101 patients who were not randomized, had entry criteria/GCP violation, or had normal histology at baseline.||percentage of patients||95% Confidence Interval|Number
765717|NCT00679432|Secondary|Endoscopic Improvement|"Greater or equal to a 1 point improvement in the mucosal appearance subscore of the UCDAI, from baseline to week 8.
As per the hierarchical testing procedure for secondary endpoints, because clinical improvement was not statistically significant in the ITT population, formal statistical comparisons for endoscopic improvement between the 2 budesonide MMX groups and placebo were not conducted."|8 weeks|Intent-to-Treat (ITT) population= primary population for efficacy/baseline characteristics analyses. ITT population= randomized patients who received study drug, and did not include patients with major entry criteria/GCP violations or normal histology at baseline (N= 509 randomized - 3[infectious colitis] - 17[normal histology at baseline] = 489).||percentage of patients||95% Confidence Interval|Number
765718|NCT00679432|Secondary|Clinical Improvement.|Clinical improvement, defined as a ≥ 3-point improvement in UCDAI from baseline to the end of Week 8.|8 weeks|Intent-to-Treat (ITT) population= primary population for efficacy/baseline characteristics analyses. ITT population= randomized patients who received study drug, and did not include patients with major entry criteria/GCP violations or normal histology at baseline (N= 509 randomized - 3[infectious colitis] - 17[normal histology at baseline] = 489).||percentage of patients||95% Confidence Interval|Number
765719|NCT00679432|Primary|Clinical and Endoscopic Remission.|Clinical and endoscopic remission defined as a Ulcerative Colitis Disease Activity Index (UCDAI) score ≤ 1, with subscores of 0 for rectal bleeding, stool frequency, and mucosal appearance and with a ≥ 1 point reduction in the endoscopic index score.|8 weeks|Intent-to-Treat (ITT) population= primary population for efficacy/baseline characteristics analyses. ITT population= randomized patients who received study drug, and did not include patients with major entry criteria/GCP violations or normal histology at baseline (N= 509 randomized - 3[infectious colitis] - 17[normal histology at baseline] = 489).||percentage of patients||95% Confidence Interval|Number
765720|NCT00679627|Secondary|Change From Baseline in the Disability Assessment in Dementia (DAD) Subscales (Initiation, Planning and Organization, Effective Performance, Basic, Instrumental, and Leisure)|The DAD assesses physical activities of daily living and instrumental-activities of daily livings of participants with Alzheimer disease. This measure is a validated, disability assessment scale that collects information regarding the ability of a participant to initiate, plan, organize, and perform activities of daily living, as based on a structured interview with the caregiver. The maximum scores were 13 for initiation, 10 for planning and organizing, and 17 for effective performance in order to yield a total maximum score of 40. These scores were normalized to a scale of 100 for analysis.A higher score, or percentage of items that can be performed represents fewer disabilities in carrying out activities of daily living while a lower percentage indicates an increase in disabilities.|Baseline, Month 24|This analysis was performed in the intent-to-treat population which included all randomized participants who had at least 1 postbaseline DAD measure.||Scores on scale||Standard Deviation|Mean
765721|NCT00679627|Secondary|Change From Baseline in the Mini–Mental State Examination (MMSE) Subscales (Orientation, Registration, Attention and Calculation, Recall, and Language)|The MMSE, is a validated, brief examination that rates subjects on orientation (total score, 10), registration (total score, 3), attention (total score, 5), calculation (total score, 5), recall (total score, 3), and language (total score, 9). The maximum score is 30 (only the higher of the two scores for attention and calculation [each with a maximum score of 5] was used). A higher score compared with baseline indicates less impairment.|Baseline, Month 24|The ITT analysis set included all randomized participants who received at least 1 dose of treatment and had at least 1 postbaseline MMSE measure.||Scores on scale||Standard Deviation|Mean
765722|NCT00679627|Secondary|Change From Baseline in Institutional Status|This table describes the number of participants who were reported as institutionalized at baseline and Month 24.|Baseline, Month 24|The ITT analysis set included all randomized participants who received at least 1 dose of treatment and had at least 1 postbaseline measure.||Number of Participants|||Number
765723|NCT00679627|Secondary|Change From Baseline in Caregiver Time Spent With the Patient Measured Using the Assessment of Subject Accommodation Status and Caregiver Burden (APAS-CarB)|The table below presents the number of days that caregiving activities were provided during the past week.|Baseline, Months 12 and 24|The ITT analysis set included all randomized participants who received at least 1 dose of treatment and had at least 1 postbaseline measure.||Days||Standard Deviation|Mean
765724|NCT00679627|Secondary|Change From Baseline in Patient Accommodation Measured Using the Assessment of Subject Accommodation Status and Caregiver Burden (APAS-CarB)|The APAS-CarB is a measure used to evaluate participant status and caregiver burden. The table below presents Patient Accommodation assessed as the percentage of participants “home with friend or relative” using the APAS-CarB.|Baseline, Months 12 and 24|An intent-to-treat (ITT) with last observation carried forward (LOCF) approach was used for the analysis. The ITT analysis set included all randomized participants who received at least 1 dose of treatment and had at least 1 postbaseline APAS-CarB measure.||Percentage of participants|||Number
765725|NCT00679627|Secondary|Change From Baseline in Disability Assessment in Dementia (DAD) Scores|The DAD assesses physical activities of daily living and instrumental-activities of daily livings of participants with Alzheimer disease. This measure is a validated, disability assessment scale that collects information regarding the ability of a participant to initiate, plan, organize, and perform activities of daily living, as based on a structured interview with the caregiver. The maximum scores were 13 for initiation, 10 for planning and organizing, and 17 for effective performance in order to yield a total maximum score of 40. These scores were normalized to a scale of 100 for analysis.A higher score, or percentage of items that can be performed represents fewer disabilities in carrying out activities of daily living while a lower percentage indicates an increase in disabilities.|Baseline, Month 24|An intent-to-treat (ITT) with last observation carried forward (LOCF) approach was used for the analysis. The ITT analysis set included all randomized participants who received at least 1 dose of treatment and had at least 1 postbaseline DAD measure.||Scores on scale||Standard Deviation|Mean
765726|NCT00679627|Secondary|Change From Baseline in the Mini–Mental State Examination (MMSE) Score|The MMSE is a brief 30-point questionnaire test that is used or the assessment of dementia patients’ cognitive impairment. Evaluation of points are as follows: 24 to 30 = no cognitive impairment, 18 to 23 = mild cognitive impairment, 0 to 17 = severe cognitive impairment. Lower scores indicate worsening.|Baseline, Month 6|An intent-to-treat (ITT) with last observation carried forward (LOCF) approach was used for the primary analysis. The ITT analysis set included all randomized participants who received at least 1 dose of treatment and had at least 1 postbaseline MMSE measure.||Scores on scale||Standard Deviation|Mean
765727|NCT00679627|Primary|The Number of Deaths Reported in Participants|An external Data Safety Monitoring Board (DSMB) was assigned for this study to monitor the progress of the study and to ensure that the safety of participants was not compromised.|Up to 2 years|The safety analysis was performed on the safety population, ie, all randomized participants who received at least one dose of the study drug.||Number of Participants|||Number
765728|NCT00679627|Primary|Change From Baseline in the Mini–Mental State Examination (MMSE) Score|The MMSE is a brief 30-point questionnaire test that is used or the assessment of dementia patients’ cognitive impairment. Evaluation of points are as follows: 24 to 30 = no cognitive impairment, 18 to 23 = mild cognitive impairment, 0 to 17 = severe cognitive impairment. Lower scores indicate worsening.|Baseline, Month 24|An intent-to-treat (ITT) with last observation carried forward (LOCF) approach was used for the primary analysis. The ITT analysis set included all randomized participants who received at least 1 dose of treatment and had at least 1 postbaseline MMSE measure.||Scores on scale||Standard Deviation|Mean
765729|NCT00681265|Secondary|Fluorescein Tear Film Break-up Time|Standard clinical assessment methodology for assessing tear stability.|120 minutes after eye drops instillation|Study N determined empirically by PI.||seconds||Standard Deviation|Mean
765730|NCT00681265|Primary|Noninvasive Tear Film Break-up Time|State-of-the-art methodology to assess tear stability.|15 minutes after eye drop instillation|Study N determined empirically by PI.||seconds||Standard Deviation|Mean
765731|NCT00681291|Primary|Change From Baseline in Activities Assessment Scale at 24 Months|The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from “No difficulty” to “Not able to do it.” The AAS has three subscales: sedentary activities (items 1–4); ambulatory activities (items 6–8); work/exercise activities (items 11–13). The AAS total and subscale scores are transformed to produce a range of 0–100, with higher values indicating greater functional activity. Subjects completed the assessment at baseline, 3 months, 6 months, 12 months and 24 months. It is the change from baseline to 3, 6, 12 and 24 months which is the primary outcome measure (Baseline calculated value minus time point calculated value). Therefore, a negative number indicates an increase in activity from baseline.|Baseline to 24 Months|Of the 88 participants in Arm 1 who started the study, 75 completed the Activities Assessment Scale at 24 months. Of the 84 participants in Arm 2 who started the study, 57 completed the Activities Assessment Scale at 24 months.||units on a scale||Standard Deviation|Mean
765882|NCT00682786|Post-Hoc|Associations Between MTHFR Genotypes and Grade 3-4 Diarrhea and/or Mucositis (Good Risk Group)|Genomic DNA was isolated from whole blood using the Puregene DNA isolation kit.|First day of treatment through 30 days after completion of surgery|2 of the patients in the Good Risk arm withdrew consent and are not included.||participants|||Number
765732|NCT00681291|Primary|Change From Baseline in Activities Assessment Scale at 12 Months|The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from “No difficulty” to “Not able to do it.” The AAS has three subscales: sedentary activities (items 1–4); ambulatory activities (items 6–8); work/exercise activities (items 11–13). The AAS total and subscale scores are transformed to produce a range of 0–100, with higher values indicating greater functional activity. Subjects completed the assessment at baseline, 3 months, 6 months, 12 months and 24 months. It is the change from baseline to 3, 6, 12 and 24 months which is the primary outcome measure (Baseline calculated value minus time point calculated value). Therefore, a negative number indicates an increase in activity from baseline.|Baseline to 12 Months|Of the 88 participants in Arm 1 who started the study, 83 completed the Activities Assessment Scale at 12 months. Of the 84 participants in Arm 2 who started the study, 70 completed the Activities Assessment Scale at 12 months.||units on a scale||Standard Deviation|Mean
765733|NCT00681291|Primary|Change From Baseline in Activities Assessment Scale at 6 Months|The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from “No difficulty” to “Not able to do it.” The AAS has three subscales: sedentary activities (items 1–4); ambulatory activities (items 6–8); work/exercise activities (items 11–13). The AAS total and subscale scores are transformed to produce a range of 0–100, with higher values indicating greater functional activity. Subjects completed the assessment at baseline, 3 months, 6 months, 12 months and 24 months. It is the change from baseline to 3, 6, 12 and 24 months which is the primary outcome measure (Baseline calculated value minus time point calculated value). Therefore, a negative number indicates an increase in activity from baseline.|Baseline to 6 Months|Of the 88 participants in Arm 1 who started the study, 83 completed the Activities Assessment Scale at 6 months. Of the 84 participants in Arm 2 who started the study, 70 completed the Activities Assessment Scale at 6 months.||units on a scale||Standard Deviation|Mean
765734|NCT00681291|Primary|Change From Baseline in Activities Assessment Scale at 3 Months|The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from “No difficulty = 1” to “Not able to do it = 5.” The AAS has three subscales: sedentary activities (items 1–4); ambulatory activities (items 6–8); work/exercise activities (items 11–13). The AAS total and subscale scores are transformed to produce a range of 0–100, with higher values indicating greater functional activity. Subjects completed the assessment at baseline, 3 months, 6 months, 12 months and 24 months. It is the change from baseline to 3, 6, 12 and 24 months which is the primary outcome measure (Baseline calculated value minus time point calculated value). Therefore, a negative number indicates an increase in activity from baseline.|Baseline to 3 Months|Of the 88 participants in Arm 1 who started the study, 81 completed the Activities Assessment Scale at 3 months. Of the 84 participants in Arm 2 who started the study, 77 completed the Activities Assessment Scale at 3 months.||units on a scale||Standard Deviation|Mean
765735|NCT00681473|Secondary|Percentage of Participants With Overall Survival|Percentages were estimated by Kaplan Meier|At 1, 3, and 5 years|||% of participants|||Number
765736|NCT00681473|Secondary|Percentage of Participants With Progression Free Survival|Clinical and/or radiographic assessments Percentages were estimated by Kaplan Meier|At 1, 3, and 5 years|||% of participants|||Number
765737|NCT00681473|Primary|Number of Participants With Late Effects > 3 Months Post RT||5 years|||Participants|||Count of Participants
765738|NCT00681538|Secondary|Mood Assessment: Change in Beck Depression Inventory - II (BDI-II)From Baseline to End of Treatment (Phase B)|This was a 21-question multiple choice self-report inventory. Subjects’ responses to the 21 questions were assigned a score ranging from zero to three, indicating the severity of the symptom. The sum of all BDI-II question scores indicated the severity of depression; score range 0-63. An decrease in score indicates an improvement in condition.|Baseline (End of week 4) - end of treatment (end of week 17)|||Score on scale||Standard Deviation|Mean
765739|NCT00681538|Secondary|Change EuroQoL Quality of Life Questionnaire (EQ-5D)From Baseline to End of Treatment (Phase B)|"The EQ-5D questionnaire provided two outcomes:
A weighted health state index visual analogue scale (VAS)
A self-rated health status VAS EQ-5D Health Status VAS Scale: 0 = worst health state imaginable to 100 = best health state imaginable. An increase in score indicates an improvement in condition.
The weighted health state index used the same VAS as above but was calculated for each assessment without imputation to account for missing values i.e., if one or more individual items was missing then the whole index was missing."|[Baseline (End of Week 4) - End of treatment (End of Week 17)|EQ-5D Health State Index Sativex n=117 and placebo n=111. EQ-5D Health Status VAS Sativex n=121 and placebo n=117.||score on scale||Standard Deviation|Mean
765740|NCT00681538|Secondary|Physician Global Impressions of Change at End of Treatment (Phase B).||End of treatment (week 17)|||participants|||Number
765741|NCT00681538|Secondary|Carer Ease of Transfer Global Impressions of Change at End of Treatment (Phase B).||End of treatment (week 17)|Sample sizes were reduced as not all subjects had a Carer to make this assessment.||participants|||Number
765742|NCT00681538|Secondary|Carer Global Impressions of Change at of Treatment (Phase B).||End of treatment (Week 17)|Sample sizes were reduced as not all subjects had a Carer to make this assessment.||participants|||Number
765743|NCT00681538|Secondary|Subject Global Impressions of Change at End of Treatment (Phase B).||End of Treatment (WeeK 17)|||participants|||Number
765744|NCT00681538|Secondary|Change in Timed 10-metre Walk From Baseline to End of Treatment (Phase B).|Only those subjects for whom it was appropriate (i.e. ambulatory subjects) were timed how long it took to walk 10 metres. Walk time was only assessed for subjects who successfully completed the Timed 10 Metre Walk. A negative difference from baseline indicates an improvement walk time.|Baseline (End of Week 4) - End of treatment (End of Week 17)|Only those subjects for whom it was appropriate (i.e. ambulatory subjects) were timed how long it took to walk 10 metres. Walk time was only assessed for subjects who successfully completed the Timed 10 Metre Walk.||Seconds||Standard Deviation|Mean
765745|NCT00681538|Secondary|Change in Motricity Index Score From Baseline to End of Treatment (Phase B)for Affected Limbs.|Arm - 3 movements were pinch grip, elbow flexion and shoulder abduction. Leg - 3 movements were ankle dorsiflexion, knee extension and hip flexion. The total arm and leg score was the addition of the score for the 3 arm movements and 3 leg movements, respectively. One point was then added to each limb score to give a maximum score of 100; minimum was 1 point. Where both arms (or both legs) were assessed, the average of the two limbs scores was used as the assessment score; otherwise the affected limb total score was used. An increase in score indicates an improvement in condition.|Baseline (End of Week 4) - End of treatment (End of Week 17)|For Arm subject numbers were 23 for Sativex and 22 for placebo. For Leg subject numbers were 91 for Sativex and 92 for placebo.||Score on scale||Standard Deviation|Mean
765746|NCT00681538|Secondary|Change in Spasticity as Measured Using the Modified Ashworth Scale From Baseline to End of Treatment (Phase B).|All 20 muscle groups were assessed for spasticity (using a 1-5 scale): 1= no increase in muscle tone to 5= passive movement is difficult and affected part is rigid in flexion or extension. The score for all 20 muscle groups were added to give a total score out of 100; minimum score was 20. A decrease in score indicates an improvement in condition.|Baseline (End of Week 4) - End of treatment (End of Week 17)|||Score on scale||Standard Deviation|Mean
765747|NCT00681538|Secondary|Change in Sleep Disruption (Daily 11-point NRS) From Baseline to End of Treatment (Phase B).|The sleep disruption NRS score was recorded by subjects via a daily call to the interactive voice response system at bedtime. Subjects were asked “On a scale of ‘0 to 10’ please indicate how you your spasticity disrupted your sleep last night” with the anchors: 0 = ‘did not disrupt sleep’ and 10 = ‘completely disrupted (unable to sleep at all)'.|Baseline (last 7 days of Week 4) - End of treatment (last 7 days of Week 17)|||Points on scale||Standard Deviation|Mean
765748|NCT00681538|Secondary|Change in Spasm Frequency (Number of Spasms Per Day) From Baseline to End of Treatment (Phase B).|The subjects’ baseline spasm frequency was the mean of the last seven days scores (Week 4) of Phase A treatment. The variable for analysis was the change in mean spasm frequency from baseline to the end of treatment (last 7 days of Week 17 Phase B).|Baseline (last 7 days of Week 4) - End of treatment (last 7 days of Week 17)|||Spasms per day||Standard Deviation|Mean
765749|NCT00681538|Secondary|Number of Subjects Showing an Improvement of at Least 30% or 50% in Their Mean NRS Spasticity Score (Phase B) From Baseline.|A subject was classified as a responder in the evaluable period provided they did not withdraw due to lack of efficacy and achieved at least a 30% or 50% reduction (i.e. improvement) in the mean NRS spasticity score from baseline (Day 1) to the end of treatment(last 7 days of Week 17 Phase B). All other subjects and subjects without evaluable data were considered non-responders.|Baseline (Day 1) - End of treatment (last 7 days of Week 17)|||participants|||Number
765750|NCT00681538|Primary|The Change in Mean Spasticity Numerical Rating Scale (NRS) Score From Baseline to End of Treatment (Phase B).|Subjects were asked “On a scale of ‘0 to 10’ please indicate the average level of your spasticity over the last 24 hours” with the anchors: 0 = ‘no spasticity’ and 10 = ‘worst possible spasticity’. They were asked to relate ‘no spasticity’ to the time prior to the onset of their spasticity.|Baseline (last 7 days of Week 4) - End of treatment (last 7 days of Week 17)|||Points on scale||Standard Deviation|Mean
765751|NCT00681564|Secondary|Tissue Plasminogen Activator Inhibitor-1 (tPAI-1)||12 weeks post periodontal therapy|Explanation of missing data in the intervention group: Blood samples obtained from two patients randomized to the periodontal intervention group were not suitable for the Luminex analysis.||ng/ml||Standard Deviation|Mean
765752|NCT00681564|Secondary|Matrix Metalloproteinase-9 (MMP-9)||12 weeks post periodontal therapy|Explanation of missing data in the intervention group: Blood samples obtained from two patients randomized to the periodontal intervention group were not suitable for the Luminex analysis.||ng/ml||Standard Deviation|Mean
765753|NCT00681564|Secondary|Myeloperoxidase (MPO)||12 weeks post periodontal therapy|Explanation of missing data in the intervention group: Blood samples obtained from two patients randomized to the periodontal intervention group were not suitable for the Luminex analysis.||ng/ml||Standard Deviation|Mean
765754|NCT00681564|Secondary|Vascular Cell Adhesion Molecule 1 (VCAM-1)||12 weeks post periodontal therapy|Explanation of missing data in the intervention group: Blood samples obtained from two patients randomized to the periodontal intervention group were not suitable for the Luminex analysis.||ng/ml||Standard Deviation|Mean
765755|NCT00681564|Secondary|Intercellular Adhesion Molecule 1 (ICAM-1)||12 weeks post periodontal therapy|Explanation of missing data in the intervention group: Blood samples obtained from two patients randomized to the periodontal intervention group were not suitable for the Luminex analysis.||ng/ml||Standard Deviation|Mean
765756|NCT00681564|Secondary|Endothelial Leukocyte Adhesion Molecule-1 (E-Selectin)|"Multiplexed immuno-cytometric assay for the simultaneous measurement of MMP-9, MPO, tPAI-1, E-Selectin, ICAM-1, and VCAM-1 in serum samples (Milliplex® MAP kit, Human Cardiovascular Disease Panel 1, Millipore®).
Luminex® 200™ IS Total System and xPONENT software were used for data acquisition and analysis."|12 weeks post periodontal therapy|Explanation of missing data in the intervention group: Blood samples obtained from two patients randomized to the periodontal intervention group were not suitable for the Luminex analysis.||ng/ml||Standard Deviation|Mean
765757|NCT00681564|Secondary|LDL Cholesterol||Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy|||mg/dL||Standard Deviation|Mean
765758|NCT00681564|Secondary|Subgingival Microbiota|Polymerase chain reaction (PCR) was used for detection of the three red-complex periodontal pathogens in periodontal pockets: Porphyromonas gingivalis (Pg), Treponema denticola (Td) and Tannerella forsythia (Tf).|12 weeks post-periodontal therapy|||participants|||Number
765759|NCT00681564|Secondary|White Blood Cell Count||Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy|||cells/mm^3||Standard Deviation|Mean
765760|NCT00681564|Secondary|Total Cholesterol||Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy|||mg/dL||Standard Deviation|Mean
765761|NCT00681564|Secondary|High-sensitivity C-Reactive Protein|The fasting plasma hs-CRP concentrations was evaluated using a quantitative solid-phase, chemiluminescent immunometric assay (Immulite 1000, Siemens).|Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy|||mg/L||Standard Deviation|Mean
766191|NCT00685659|Primary|Percent Days Cocaine Use|Percent of days during the follow up that there was any cocaine use|6 months (approproximately study days 91 - 180)|N's represent the participants at three months for whom complete Time Line Follow Back data was available.||percentage of days||Standard Error|Mean
765762|NCT00681564|Primary|Brachial Artery Flow-mediated Dilation|All the assessments of vascular function were performed in the morning, in a temperature controlled room, with participants required to fast for at least 8 hours. Flow-mediated, endothelium dependent vasodilatation of the brachial artery (FMD) was measured using the technique described by Celermajer et al. using the guidelines reported by Coretti et al. FMD was calculated as the percentage of change in the diameter of brachial artery measured 45-60 s after cuff release in relation to the baseline measure (FMD%).|Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy|The primary outcome (difference on endothelium-dependent brachial artery FMD at baseline and three months after randomization) and the secondary outcome (hs-CRP, glucose, blood lipid profile and cardiovascular biomarkers) were analyzed using kruskal-wallis and unpaired t test depending on the distribution of the variables.||Percentage of dilatation of brachial art||Standard Deviation|Mean
765763|NCT00681590|Secondary|Change From Baseline in Serum 25-hydroxyvitamin D Levels||baseline and 6 months|||ng/ml||Standard Deviation|Mean
765764|NCT00681590|Primary|Number of Participants Who Develop Hypercalcemia|calcium serum levels measured at baseline and at the end of the intervention (6-months)|6 months|||participants|||Number
765765|NCT00681629|Secondary|Evaluate Safety and Tolerability by Evaluation of the Incidence of Adverse Events|Listing of all adverse event or SAE´s to show the safety and tolerability.|4 month|No data were reported as no participants completed the study||number of events|||Number
765766|NCT00681629|Secondary|Evaluate Safety and Tolerability by Evaluation of Concomitant Medication|Listing of all concomitant medication to show the efficacy and safety.|4 month|No data were reported as no participants completed the study||Name of concomitant medication|||Number
765767|NCT00681629|Secondary|Evaluate Safety and Tolerability by Evaluation of Laboratory Tests|Measuring of: B-Haemoglobin (g/dl), B-Haematocrit(%), B-Erythrocyte count(pl), B-Leucocytes count (nl), B-Platelet count(nl), Complete blood count (nl), B-Leucocytes differential count (%), B-HbA1c(%), S-ALAT (U/l), S-ASAT (U/l), S-GGT (U/l), P-Glucose (fasting)(mh/dl), S-prolactin level (ng/ml), S-Pregnancy test (IU/l), Qualitative analysis of urine with Stix®,Urine pregnancy. Comparing results with standard values.|4 month|No data were reported as no participants completed the study||depending on the Lab test (see above)||Full Range|Mean
765768|NCT00681629|Secondary|Evaluate Safety and Tolerability by Evaluation of Weight/Waist Circumference|Measuring of weight and waist circumference in centimeter.|4 month|No data were reported as no participants completed the study||centimeters||Standard Deviation|Mean
765769|NCT00681629|Secondary|Assess Health Economy Improvements in Terms of a Reduction in Treatment Costs and Loss of Productivity by Determination of the Need for Any Additional Antipsychotic Medication|Concomitant psychotropic drugs will be coded (ATC = Drug code) to allow a comparison of the number of drugs used per ATC class and per treatment visit. The drugs used will be listed by keeping their brand name for allowing to translate them into costs.|4 month|No data were reported as no participants completed the study||Drugs||Standard Deviation|Mean
765770|NCT00681629|Secondary|Assess Health Economy Improvements in Terms of a Reduction in Treatment Costs and Loss of Productivity by Determination of the Total Number of Days the Patient Was Not Able to Work or go to School or Complete Routine Daily Activities|The number of lost work days, lost school days or days without completing routine daily activities will be evaluated. With any number of lost workdays or lost school days or without completing routine daily activities, the costs will increase and the productivity will decrease.|4 month|No data were reported as no participants completed the study||days||Standard Deviation|Mean
765771|NCT00681629|Secondary|Assess Health Economy Improvements in Terms of a Reduction in Treatment Costs and Loss of Productivity by Determination of the Total Cost by Number of Days With Hospitalization|Any hospitalisation days in inpatients units and emergency ward stays will be recorded. At each hospitalisation, the number of days will be computed and at each visit, the cumulative total number of days will be used to calculate total costs. As higher the number of hospitalisation days as higher the costs per patient.|4 month|No data were reported as no participants completed the study||days||Standard Deviation|Mean
765772|NCT00681629|Secondary|Evaluate the Level of the Patients' (Subjective) Satisfaction Using the CSQ-8 Scale (Client Satisfaction Questionnaire)|"The 'CSQ-8 is a brief, self-administered method to monitor the consumer's satisfaction with services in outpatient psychotherapy, showing high internal consistency. It is identified as a core subset of the general CSQ covering 8 Likert-type items with four response choices where '1' indicates the lowest and '4' the highest degree of satisfaction."|4 month|No data were reported as no participants completed the study||Scores on a scale||Standard Deviation|Mean
765773|NCT00681629|Secondary|Assess Compliance/Medication Adherence Using the MARS Scale (Medication Adherence Rating Scale)|The 'Medication Adherence Rating Scale' (MARS) is a reliable and valid self-reporting tool for investigation of the compliance in psychiatric patients also recognizing the complexity of compliance behaviour. 10 questions on medication attitude have to be answered by 'yes' or 'no' (8 times 1= no and Yes = 0 and twice 1= no, Yes =1). Results will be descriptively summarized. Summarized results minimum 0: low medication adherence, maximum 10: high medication adherence.|4 month|No data were reported as no participants completed the study||Participants|||Number
765774|NCT00681629|Secondary|Assess Patient Engagement to Therapy Using the SES Scale (Service Engagement Scale)|"The 'SES is a 14-item measure consisting of statements that assess the client specific engagement with services. It will be rated on a four-point Likert scale (not at all / rarely / sometimes / most of the time) by the investigator. The total score ranges from min. 0 to a max. of 42. Higher scores indicate lower engagement."|4 month|No data were reported as no participants completed the study||Scores on a scale||Standard Deviation|Mean
765775|NCT00681629|Secondary|Assess Quality of Life Levels Using the RSM Scale (Riedel-Spellmann-Musil) Scale|"The '(RSM is a new 36-item measure validated to assess the QoL in different dimensions of schizophrenic patient treated with antipsychotics. It will be rated on a four-point Likert scale (not / rather not / rather yes / yes) by the patient and the investigator. The total score ranges from min. 0 to max. of 108. Higher scores indicate higher QoL."|4 month|No data were reported as no participants completed the study||Scores on a scale||Standard Deviation|Mean
765802|NCT00681863|Secondary|Patient Global Impression - Improvement|Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).|week 16|This outcome measure was not analyzed due to the premature ending of the trial.|||||
765776|NCT00681629|Secondary|Assess Quality of Life Levels Using the Q-LES-Q-18 (Quality of Life Enjoyment and Satisfaction) Questionnaire|Q-LES-Q-18 will allow to generate a general QoL-index which will be used for the analysis and is defined as the average of the single scores for all 18 items. Scoring will be carried out from 1-5 per item (never / rarely / sometimes / frequently / all the time). Results will be descriptively summarized.|4 month|No data were reported as no participants completed the study||Scores on a scale||Standard Deviation|Mean
765777|NCT00681629|Secondary|"Vocational Occupational Index VOC Score"|The “VOC” index will assess the following 7 items: 1 fulltime gainful employment, 2 homemaker or student, 3 part-time gainful employment (20 hours per week or less), 4 retired, 5 full or part-time volunteer, 6 on medical or psychiatric leave of absence, 7 unemployed, whether or not expected to work. Results will be descriptively summarized. The VOC index will be completed at each visit. Difference from baseline of the index will be derived at each assessment|Up to 18 months (V1 Day 1, V2 Month 1, V3 Month 3, V4 Month 6, V5 Month 12, V6 Month 18)|No data were reported as no participants completed the study||Scores on a scale||Standard Deviation|Mean
765778|NCT00681629|Secondary|EQ-5D (European Quality of Life Questionnaire) Score|"The EQ-5D questionnaire is a generic measure of health status. It defines health in terms of five dimensions:1 (Mobility); 2 (Self-care); 3 (Usual activity); 4 (Pain/Discomfort); 5 (Anxiety/Depression).
The minimum possible value is 5 (one point for each dimension) and the maximum possible values is 15 (3 points for each dimension). Each dimension has 3 levels of severity- no problems, some problems and extreme problems. Higher scores indicate more problems."|4 month|No data were reported as no participants completed the study||Scores on a scale||Standard Deviation|Mean
765779|NCT00681629|Secondary|PSP (Personal and Social Performance) Scale Score|"The '(PSP rating scale (100 until 0) used by clinicians for assessment of 4 main domains of functioning in adult patients acc. (a) socially useful activities including work and study, (b) personal and social relationships, (c) self-care, and (d) disturbing and aggressive behavior. Higher scores indicate better patient condition and performance."|4 month|No data were reported as no participants completed the study||Scores on a scale||Standard Deviation|Mean
765780|NCT00681629|Secondary|GAF (Global Assessment of Functioning) Scale Score|"The GAF is a numeric rating scale used by clinicians for assessment of the social, occupational, psychological functioning of adult patients. The scale represents a hypothetical continuum of mental health illness providing a descending scoring code from 100 until 0. Higher scores indicate better patient condition and performance."|4 month|No data were reported as no participants completed the study||Scores on a scale||Standard Deviation|Mean
765781|NCT00681629|Secondary|Symptomatic Outcome Using the PANSS-8 Scales(Positive and Negative Symptoms) Scale Score|The schizophrenic symptomatology will be measured by the Positive and Negative Syndrome Scale (PANSS) providing 8 items of which each is rated on a severity scale ranging from 1-7, (1= absent - 7 = extreme severe. higher scores implying higher severity.|4 month|No data were reported as no participants completed the study||Scores on a scale||Standard Deviation|Mean
765782|NCT00681629|Secondary|Symptomatic Outcome Using CGI-S (Clinical Global Impression-Schizophrenia) Scale|With the CGI-S the rate of the severity of a patient’s symptoms (positive, negative, cognitive, depressive and overall) using a scale ranging from 1 (normal, not ill) to 7 (among the most severely ill) is measured - higher scores implying higher severity.|4 month|No data were reported as no participants completed the study||Scores on a scale||Standard Deviation|Mean
765783|NCT00681629|Secondary|Subjective Well-being Using the SWN-K (Subjective Well-being Under Neuroleptics Scale) Total Score|The SWN-K is comprised of 20 questions, each of which is rated using a 6 point scale ranging from 1 (not at all) to 6 (very much). Possible scores range from 20-120, with higher scores implying higher subjective well-being.|4 month|No data were reported as no participants completed the study||Scores on a scale||Standard Deviation|Mean
765784|NCT00681629|Primary|Subjective Well-being in Patients Treated for Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder, Delusional Disorder or Psychotic Disorder Not Otherwise Specified Using the SWN-K (Subjective Well-being Under Neuroleptics) Scale|The SWN-K is comprised of 20 questions, each of which is rated using a 6 point scale ranging from 1 (not at all) to 6 (very much). Possible scores range from 20-120, with higher scores implying higher subjective well-being.|4 months|No data were reported as no participants completed the study||Scores on a scale||Standard Deviation|Mean
765785|NCT00681668|Secondary|Electrocardiogram (ECG), Vital Signs, Laboratory|"Safety parameter:s electrocardiogram (ECG), vital signs, laboratory
no participants analysed - terminated study"|Baseline Day 1 to final visit 28 weeks|Data not analyzed, study terminated||participants|||Number
765786|NCT00681668|Secondary|Change in Functional Outcome: Global Assessment of Functioning (GAF), Parental Bonding Questionnaire (PBQ)|Change in functional outcome: Global Assessment of Functioning (GAF),scale of 1-100 (1 = severe symptoms - 100 = no symptoms) Parental bonding Questionnaire (PBQ) no participants analysed - terminated study|Baseline Day 1 to final visit 28 weeks|Data not analyzed, study terminated||scores on a scale||Full Range|Median
765787|NCT00681668|Secondary|Change in Efficacy Scales: Clinical Global Impression (CGI), Montgomery Asberg Depression Rating Scale (MADRS), Brief Psychiatric Rating Scale (BPRS)|"Change in efficacy scales: Clinical Global Impression (CGI),Scale of 1-7 (1 = normal or no change - 7 = extremely ill or extreme changes).
Montgomery Asberg Depression Rating scale (MADRS) 10 questions with a scale of 1-4 (1 = no symptoms - 4 = severe symptoms), higher score = worst values.
Brief Psychiatric rating scale (BPRS)- 24 symptom constructs, each to be rated in a 7-point scale of severity ranging from 'not present' to 'extremely severe' no participants analysed - terminated study"|Baseline Day 1 to final visit 28 weeks|Data not analyzed, study terminated||Units on a scale||Full Range|Mean
765788|NCT00681668|Primary|The Change in the Hamilton Rating Scale for Depression (HAM-D)|HAM-D is a 17-21 item observer-rated scale to assess presence and severity of depressive states. 9 items are scored 0-4, whereas the further 8 are scored 0-2, as these represent variables which do not lend themselves to quantitative rating (0=absent; 1=doubtful or slislight; 2=clearly present). Higher scores indicate higer depressive state|Baseline Day 1 to final visit 28 weeks|||scores on a HAM-D scale||Full Range|Mean
765789|NCT00681811|Primary|Days of Exposure to HGT-1111|End of study was defined as until HGT-1111 was commercially available, the participant’s participation was discontinued, or the study was terminated by the Sponsor.|Baseline until end of study (Week 139)|Safety population was defined as all enrolled participants who received at least one study infusion (or any portion of a dose) of HGT-1111.||Days||Standard Deviation|Mean
765790|NCT00681811|Secondary|Score of Gross Motor Function Measurement (GMFM)|Gross motor function was measured using GMFM-88 at 6-month intervals. The GMFM-88 item scores were summed to calculate a total GMFM-88 score. For each GMFM-88 item, the score was between 0 (minimal) to 3 (maximum). The total GMFM-88 score was between 0 (minimal) to 264 (maximum). Decrease in GMFM score indicates disease progression.|Baseline until end of study (Week 139)|"Safety population. Number of participants analysed signifies participants who were evaluable for the respective arms under this outcome measure."||scores on a scale||Standard Deviation|Mean
765791|NCT00681811|Secondary|Level of White Matter Metabolites|Level of white matter metabolites [N-acetyl Aspartate (NAA)] measured at 6-month intervals in HGT-MLD-049 (NCT00681811).|Baseline until end of study (Week 139)|"Safety population. Number of participants analysed signifies participants who were evaluable for the respective arms under this outcome measure. No participants were analysed after Month 18, hence, data were not available after Month 18."||nmol/L||Standard Deviation|Mean
765792|NCT00681811|Secondary|Level of Cerebrospinal Fluid (CSF) Sulfatide|Level of CSF sulfatide measured at 6-month intervals in HGT-MLD-049 (NCT00681811).|Baseline until end of study (Week 139)|"Safety population. Number of participants analysed signifies participants who were evaluable for the respective arms under this outcome measure."||nanomole per liter (nmol/L)||Standard Deviation|Mean
765793|NCT00681824|Secondary|Number of Participants With Surgical Site Infections (SSI) According to National Nosocomial Infection Surveillance (NNIS) Criteria||within 1 month following surgery|"Primary Safety Data Set
One participant (FS VH S/D 500 s-apr arm) removed from analysis due to subsequent surgery unrelated to CSF leakage/surgical site infection that involved re-durotomy"||participants|||Number
765794|NCT00681824|Secondary|Incidence of Surgical Site Infections (SSI) According to National Nosocomial Infection Surveillance (NNIS) Criteria||within 1 month following surgery|"Primary Safety Data Set
One participant (FS VH S/D 500 s-apr arm) removed from analysis due to subsequent surgery unrelated to CSF leakage/surgical site infection that involved re-durotomy"||percentage of participants||95% Confidence Interval|Number
765795|NCT00681824|Primary|Number of Participants With Cerebrospinal Fluid (CSF) Leakage Observed After Surgery|"Study-relevant CSF leakage is defined as one or more of following:
Discrete subcutaneous or subgaleal CSF collection (pseudomeningocele) in surgical area confirmed by positive test for β2–transferrin, or by computed tomography (CT) or magnetic resonance imaging (MRI)
Epidural CSF collection in surgical area depicted by CT or MRI
Leakage of CSF through surgical wound observed during physical examination, confirmed by a positive test for β2–transferrin
Progressive pneumatocephalus (air in subarachnoidal space) depicted by repeat CT in absence of CSF drainage."|33 +/- 3 days after surgery|"Intent to treat
One participant (SoC arm) received products other than FS VH S/D 500 s-apr for sealing of dura sutures and was removed from analysis
Two participants (FS VH S/D 500 s-apr arm) removed from analysis due to (1) subsequent surgery unrelated to CSF leakage/surgical site infection that involved re-durotomy (2) withdrew from study"||participants|||Number
765796|NCT00681824|Secondary|Number of Participants With Procedures Resulting From the Treatment of CSF Leaks|The number of participants with surgical revisions, number and duration of compression bandage applications and of liquor drainage procedures.|until resolution or 30 days after final follow-up visit (Day 33+/-3), whichever is first|"Intent to treat
One participant (SoC arm) received products other than FS VH S/D 500 s-apr for sealing of dura sutures and was removed from analysis
One participant (FS VH S/D 500 s-apr arm) removed from analysis due to subsequent surgery unrelated to CSF leakage/surgical site infection that involved re-durotomy"||participants|||Number
765797|NCT00681824|Secondary|Incidence of Procedures Resulting From the Treatment of CSF Leaks|The incidence of surgical revisions, number and duration of compression bandage applications and of liquor drainage procedures|until resolution or 30 days after final follow-up visit (Day 33+/-3), whichever is first|"Intent to treat
One participant (SoC arm) received products other than FS VH S/D 500 s-apr for sealing of dura sutures and was removed from analysis
One participant (FS VH S/D 500 s-apr arm) removed from analysis due to subsequent surgery unrelated to CSF leakage/surgical site infection that involved re-durotomy"||percentage of participants||95% Confidence Interval|Number
765798|NCT00681824|Primary|Incidence of Cerebrospinal Fluid (CSF) Leakage Observed After Surgery|"Study-relevant CSF leakage is defined as one or more of following:
Discrete subcutaneous or subgaleal CSF collection (pseudomeningocele) in surgical area confirmed by positive test for β2-transferrin, or by computed tomography (CT) or magnetic resonance imaging (MRI)
Epidural CSF collection in surgical area depicted by CT or MRI
Leakage of CSF through surgical wound observed during physical examination, confirmed by a positive test for β2-transferrin
Progressive pneumatocephalus (air in subarachnoidal space) depicted by repeat CT in absence of CSF drainage."|33 +/- 3 days after surgery|"Intent to treat
One participant (SoC arm) received products other than FS VH S/D 500 s-apr for sealing of dura sutures and was removed from analysis
Two participants (FS VH S/D 500 s-apr arm) removed from analysis due to (1) subsequent surgery unrelated to CSF leakage/surgical site infection that involved re-durotomy (2) withdrew from study"||percentage of participants||95% Confidence Interval|Number
765799|NCT00681863|Secondary|Frequency of Patients With Possible Clinically Significant Abnormalities for Laboratory Parameters|Frequency of patients with possible clinically significant abnormalities for laboratory parameters (blood hematology and electrolyte assessments, serum chemistry, including follicle-stimulating hormone (FSH), luteinizing hormone (LH) and estradiol for pubertal female patients, prolactin in all patients, testosterone in pubertal male patients, urine analysis)|Baseline and 24 weeks|Observed Cases Treated set (OC TS). All participants in Treated Set having observed data at the particular timepoint.||participants|||Number
765800|NCT00681863|Secondary|Patient Global Impression - Improvement|Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).|week 24|The Full Analysis Set (FAS) with last observation carried forward (LOCF).||participants|||Number
765801|NCT00681863|Secondary|Patient Global Impression - Improvement|Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).|week 20|This outcome measure was not analyzed due to the premature ending of the trial.|||||
770371|NCT00711009|Secondary|Mean Change From Baseline in Lipase (Units/Liter)|Included in measures of metabolic toxicity|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||units/liter||Standard Deviation|Mean
765803|NCT00681863|Secondary|Patient Global Impression - Improvement|Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).|week 12|This outcome measure was not analyzed due to the premature ending of the trial.|||||
765804|NCT00681863|Secondary|Patient Global Impression - Improvement|Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).|week 8|This outcome measure was not analyzed due to the premature ending of the trial.|||||
765805|NCT00681863|Secondary|Patient Global Impression - Improvement|Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).|week 4|This outcome measure was not analyzed due to the premature ending of the trial.|||||
765806|NCT00681863|Secondary|Patient Global Impression - Improvement|Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).|week 3|This outcome measure was not analyzed due to the premature ending of the trial.|||||
765807|NCT00681863|Secondary|Patient Global Impression - Improvement|Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).|week 2|This outcome measure was not analyzed due to the premature ending of the trial.|||||
765808|NCT00681863|Secondary|Patient Global Impression - Improvement|Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).|week 1|This outcome measure was not analyzed due to the premature ending of the trial.|||||
765809|NCT00681863|Secondary|Clinical Global Impressions - Improvement|Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).|week 24|The Full Analysis Set (FAS) with last observation carried forward (LOCF).||participants|||Number
765810|NCT00681863|Secondary|Clinical Global Impressions - Improvement|Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).|week 20|This outcome measure was not analyzed due to the premature ending of the trial.|||||
765811|NCT00681863|Secondary|Clinical Global Impressions - Improvement|Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).|week 16|This outcome measure was not analyzed due to the premature ending of the trial.|||||
765812|NCT00681863|Secondary|Clinical Global Impressions - Improvement|Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).|week 12|This outcome measure was not analyzed due to the premature ending of the trial.|||||
765813|NCT00681863|Secondary|Clinical Global Impressions - Improvement|Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).|week 8|This outcome measure was not analyzed due to the premature ending of the trial.|||||
765814|NCT00681863|Secondary|Clinical Global Impressions - Improvement|Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).|week 4|This outcome measure was not analyzed due to the premature ending of the trial.|||||
765815|NCT00681863|Secondary|Clinical Global Impressions - Improvement|Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).|week 3|This outcome measure was not analyzed due to the premature ending of the trial.|||||
765816|NCT00681863|Primary|Patients With Adverse Events Leading to Discontinuation of Trial Drug|Number of patients with Adverse Events leading to discontinuation of trial drug|24 Weeks|Treated set||participants|||Number
765817|NCT00681863|Secondary|Clinical Global Impressions - Improvement|Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).|week 2|This outcome measure was not analyzed due to the premature ending of the trial.|||||
765818|NCT00681863|Secondary|Clinical Global Impressions - Improvement|Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).|week 1|This outcome measure was not analyzed due to the premature ending of the trial.|||||
765819|NCT00681863|Secondary|Clinical Global Impressions - Severity of Illness, Categorized|"Assessment of the overall severity of illness on a scale ranging from 1 (not at all ill) to 7 (among the most extremely ill patients).
Overall improvement during the last week compared to baseline ranging from 1 (very much improved), 2 (much improved), to 7 (very much worse). Responder has 'very much' or 'much' improvement. Non responder has less improvement than 'much' improvement."|week 24|The Full Analysis Set (FAS) with last observation carried forward (LOCF).||participants|||Number
765820|NCT00681863|Secondary|Clinical Global Impressions - Severity of Illness|Overall improvement during the last week compared to baseline ranging from 1 (very much improved), 2 (much improved), to 7 (very much worse). Responder has 'very much' or 'much' improvement. Non responder has less improvement than 'much' improvement.|week 24|The Full Analysis Set (FAS) with last observation carried forward (LOCF).||score on a scale||Standard Deviation|Mean
765821|NCT00681863|Secondary|Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale|Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe).|baseline and Week 24|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.||Score on a scale||Standard Deviation|Mean
765823|NCT00681863|Secondary|Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale|Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe).|baseline and Week 16|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.||Score on a scale||Standard Deviation|Mean
765824|NCT00681863|Secondary|Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale|Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe).|baseline and Week 12|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.||Score on a scale||Standard Deviation|Mean
765825|NCT00681863|Secondary|Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale|Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe).|baseline and Week 8|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.||Score on a scale||Standard Deviation|Mean
765826|NCT00681863|Secondary|Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale|Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe).|baseline and Week 4|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.||Score on a scale||Standard Deviation|Mean
765827|NCT00681863|Secondary|Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale|Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe).|baseline and Week 3|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.||Score on a scale||Standard Deviation|Mean
765828|NCT00681863|Secondary|Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale|Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe).|baseline and Week 2|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.||Score on a scale||Standard Deviation|Mean
765829|NCT00681863|Secondary|Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale|Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe).|baseline and Week 1|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.||Score on a scale||Standard Deviation|Mean
765830|NCT00681863|Secondary|Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale|Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50.|baseline and Week 24|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.||Score on a scale||Standard Deviation|Mean
765831|NCT00681863|Secondary|Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale|Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50.|baseline and Week 20|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.||Score on a scale||Standard Deviation|Mean
765832|NCT00681863|Secondary|Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale|Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50.|baseline and Week 16|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.||Score on a scale||Standard Deviation|Mean
765833|NCT00681863|Secondary|Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale|Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50.|baseline and Week 12|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.||Score on a scale||Standard Deviation|Mean
765834|NCT00681863|Secondary|Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale|Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50.|baseline and Week 8|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.||Score on a scale||Standard Deviation|Mean
765835|NCT00681863|Secondary|Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale|Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50.|baseline and week 4|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.||Score on a scale||Standard Deviation|Mean
765836|NCT00681863|Secondary|Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale|Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50.|baseline and Week 3|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.||Score on a scale||Standard Deviation|Mean
765837|NCT00681863|Secondary|Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale|Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50.|baseline and Week 2|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.||Score on a scale||Standard Deviation|Mean
765838|NCT00681863|Secondary|Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale|Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50.|baseline and Week 1|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.||Score on a scale||Standard Deviation|Mean
765839|NCT00681863|Secondary|Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale|Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe).|baseline and Week 24 (end of treatment visit)|The Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).||Score on a scale||Standard Deviation|Mean
765840|NCT00681863|Secondary|Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale|Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50.|baseline and week 24|The Full Analysis Set (FAS) with last observation carried forward (LOCF).||Score on a scale||Standard Deviation|Mean
765841|NCT00681889|Secondary|Efficacy by Measuring Mean Change of BCVA||Prospective||||||
765842|NCT00681889|Secondary|Efficacy by Comparison Size and Extent of Blood Vessels in Baseline and Follow-up Corneal Photographs||Prospective||||||
765843|NCT00681889|Primary|Incidence and Severity of Other Adverse Events, as Identified by Physical Examination, Subject Reporting, and Changes in Vital Signs||16 Weeks||||||
765844|NCT00681889|Primary|Incidence and Severity of Ocular Adverse Event|Incidence and severity of ocular adverse events, as identified by eye examination and visual acuity testing|16 Weeks|All participants enrolled into the study were analyzed.||participants|||Number
765845|NCT00682357|Secondary|Change in Serum Cortisol|Cortisol levels were measured over 28 days. Outcome represents mean change in cortisol level between baseline visit and day 28.|Change from Baseline Visit to Day 28|||mcg/dL||Standard Deviation|Mean
765846|NCT00682357|Secondary|Change in Testosterone|Outcome represents the mean change in testosterone level from baseline visit to day 28.|Change from Baseline Visit to Day 28|Only males randomized to Group 1 - Standard Dose were included in this analysis.||ng/dL||Standard Deviation|Mean
765847|NCT00682357|Primary|Change in Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b)|Outcome represents the mean change in serum biomarkers of bone breakdown (TRACP-5b) from baseline visit to day 28.|Change from Baseline Visit to Day 28|||U/L||Standard Deviation|Mean
765848|NCT00682357|Primary|Change in Serum Osteocalcin|Change in serum markers of bone formation (osteocalcin) from Day 0 to Day 28.|Change from Baseline Visit to Day 28|||ng/mL||Standard Deviation|Mean
765849|NCT00682461|Primary|Percentage of Participants With Oral Soft Tissue Related Adverse Events at Week 14|Oral Soft Tissue related adverse events= Any abnormality occuring in any of these: labial mucosa (including lips), gingival mucosa, buccal mucosa, mucogingival folds, hard and soft palates, tonsilar and pharyngeal areas, tongue, sublingual and submandibular areas, and salivary glands|From baseline to Week 14|Analysis was based on safety population, which consisted of all randomized participants who took at least one dose of the study medication.||Percentage|||Number
765850|NCT00682461|Primary|Percentage of Participants With Oral Soft Tissue Related Adverse Events at Week 12|Oral Soft Tissue related adverse events= Any abnormality occuring in any of these: labial mucosa (including lips), gingival mucosa, buccal mucosa, mucogingival folds, hard and soft palates, tonsilar and pharyngeal areas, tongue, sublingual and submandibular areas, and salivary glands|From baseline to Week 12|Analysis was based on safety population, which consisted of all randomized participants who took at least one dose of the study medication.||Percentage|||Number
765851|NCT00682461|Primary|Percentage of Participants With Oral Soft Tissue Related Adverse Events at Week 6|Oral Soft Tissue related adverse events= Any abnormality occuring in any of these: labial mucosa (including lips), gingival mucosa, buccal mucosa, mucogingival folds, hard and soft palates, tonsilar and pharyngeal areas, tongue, sublingual and submandibular areas, and salivary glands|From baseline to Week 6|Analysis was based on safety population, which consisted of all randomized participants who took at least one dose of the study medication.||Percentage|||Number
765852|NCT00682461|Secondary|Percentage of Participants With Adverse Events|"Adverse Event=any untoward medical occurrence in a subject following administration of an investigational product, which did not necessarily have a causal relationship with this treatment.
Serious Adverse Event=any untoward medical occurrence that at any dose; results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect"|From baseline to Week 14|Analysis was based on safety population, which consisted of all randomized participants who took at least one dose of the study medication.||Percentage|||Number
765853|NCT00682461|Primary|Percentage of Participants With Oral Soft Tissue Related Adverse Events at Week 1|Oral Soft Tissue related adverse events= Any abnormality occuring in any of these: labial mucosa (including lips), gingival mucosa, buccal mucosa, mucogingival folds, hard and soft palates, tonsilar and pharyngeal areas, tongue, sublingual and submandibular areas, and salivary glands|From baseline to Week 1|Analysis was based on safety population, which consisted of all randomized participants who took at least one dose of the study medication.||Percentage|||Number
765854|NCT00682539|Secondary|To Explore the Structural Mechanisms of the Effect on Diabetic Macular Edema as Assessed by Fluorescein Angiography and Ultra High-resolution Optical Coherence Tomography. To Observe the Changes in Retinal Function a Microperimetry is Assessed.|Area of leakage and non perfusion is measured in FA, morphologic details like presence of cysts or sub retinal fluid is evaluated in OCT. Data is still under evaluation.|12 month||06/2016||||
765855|NCT00682539|Primary|Efficacy of the Treatment Assessed by Standard Optical Coherence Tomography (OCT)|Efficacy of the treatment with intravitreal administered injections of anti VEGF (Bevacizumab (Avastin®) or Ranibizumab (Lucentis®) ) compared with triamcinolone (Volon A®) in patients with diabetic macular edema is measured with standard Optical Coherence Tomography - (OCT): units: µm; scale range: 200-800; higher values are considered worse outcome|12 months|||µm||Standard Deviation|Mean
765856|NCT00682539|Primary|Efficacy of the Treatment Assessed With Visual Acuity Measured by ETDRS Charts.|Efficacy of the treatment with intravitreal administered injections of anti VEGF (Bevacizumab (Avastin®) or Ranibizumab (Lucentis®) ) compared with triamcinolone (Volon A®) in patients with diabetic macular edema is examined using Visual acuity measurements with ETDRS charts: units: logMAR; scale range: -0.1 to 1.0; higher values are considered worse outcome|12 month|||logMAR||Standard Deviation|Mean
765857|NCT00682565|Secondary|Participants With 1 mm ST Segment Depression During ETT-3|ST Segment Depression measured by Electrocardiography while performing ETT-3.|1 day|The Safety ETT Population consists of all patients in the Randomized Population who received any study drug and who performed ETT-3. However, majority of patients did not have ECGs assessable (per protocol) for 1 mm ST depression.||Participants|||Number
765883|NCT00682786|Post-Hoc|Associations Between MTHFR Genotypes and Grade 3-4 Diarrhea and/or Mucositis (Poor Risk Group)|Genomic DNA was isolated from whole blood using the Puregene DNA isolation kit.|First day of treatment through 30 days after completion of surgery|2 of the patients in the Poor Risk arm withdrew consent and are not included.||participants|||Number
765858|NCT00682565|Secondary|Participants Stopping ETT-3 for Angina at Any Stage|"This Outcome Measure includes all participants who stopped ETT-3 for angina at any stage, not only those who stopped at a stage earlier than ETT-B.
Note: All 9 subjects who stopped ETT-3 for angina also stopped ETT-B for angina."|1 day|The Safety ETT Population consists of all patients in the Randomized Population who received any study drug and who performed ETT-3.||Participants|||Number
765859|NCT00682565|Secondary|Change in Exercise Duration During ETT-3 vs. ETT-B||1 day|The Safety ETT Population consists of all patients in the Randomized Population who received any study drug and who performed ETT-3.||seconds||Standard Deviation|Mean
765860|NCT00682565|Secondary|Participants Stopping ETT-3 for Any Reason at Stage Earlier Than ETT-B|The Modified Naughton Exercise Treadmill Test was employed in this study. Exercise Treadmill Test 3 (ETT-3) was performed during the last 2 hours of the 20-hour infusion of study drug or placebo. Baseline Exercise Treadmill Test (ETT-B) was performed prior to dosing.|1 day|The Safety ETT Population consists of all patients in the Randomized Population who received any study drug and who performed ETT-3.||Participants|||Number
765861|NCT00682565|Primary|Participants Stopping Exercise Treadmill Test 3 (ETT-3) for Angina at Stage Earlier Than Baseline Exercise Treadmill Test (ETT-B)|The Modified Naughton Exercise Treadmill Test was employed in this study. Exercise Treadmill Test 3 (ETT-3) was performed during the last 2 hours of the 20-hour infusion of study drug or placebo. Baseline Exercise Treadmill Test (ETT-B) was performed prior to dosing.|1 day|The Safety ETT Population consists of all patients in the Randomized Population who received any study drug and who performed ETT-3.||Participants|||Number
765862|NCT00682643|Secondary|Change From Baseline in the Daily Reflective Total Nasal Symptom Score (rTNSS) for the Indicated Study Periods|rTNSS was evaluated on a 4-point categorical scale (sum of the scores for rhinorrhea, nasal congestion, nasal itching, and sneezing; range=0-12). The data collected were used as a measure for treatment compliance. The scores on the scale were based on the severity of each nasal symptom: 0=none (symptom is not present); 1=mild (sign/symptom is clearly present but minimal awareness; easily tolerated); 2=moderate (definite awareness of sign/symptom that is bothersome but tolerable); 3=severe (sign/symptom is hard to tolerate; causes interference with activities of daily living and/or sleeping).|Baseline, Weeks 1 to 26, Weeks 27 to 52, Weeks 53 to 78, and Weeks 79 to 104|ITT Population||scores on a scale||Standard Error|Least Squares Mean
765863|NCT00682643|Secondary|Percent Change From Baseline in the Funduscopic Horizontal Cup-to-disc Ratio at Week 104|"The funduscopic horizontal cup-to-risk ratio assesses the progression of glaucoma. Percent change from baseline in funduscopic horizontal cup-to-disc ratio at Week 104 was calculated by substracting the baseline value from the Week 104 value (both expressed as a percent). The cup-to-disc ratio compares the diameter of the cup portion of the optic disc with the total diameter of the optic disc. A large cup-to-disc ratio may imply glaucoma or other pathology."|Baseline and Week 104|ITT Population. The number analyzed reflects those participants remaining in the study and contributing data at the indicated time points.||percent change||Standard Deviation|Mean
765864|NCT00682643|Secondary|Change From Baseline in Logarithm of the Minimum Angle of Resolution (LogMAR) Visual Acuity (VA) Using Early Treatment Diabetic Retinopathy Study (ETDRS) Charts at Week 52 and Week 104|ETDRS charts are used to measure VA (the ability to resolve fine image details). Participants must have had a best-corrected distance VA of =< 0.18 on the LogMAR scale using ETDRS charts in both eyes measured separately. The LogMAR scale (expressed as the [decadic] logarithm of the minimum angle of resolution [range from +1.00 to -0.30]) converts the geometric sequence of a traditional chart to a linear scale. It measures VA loss; positive values indicate vision loss, whereas negative values denote normal or better VA. A lower LogMAR value indicates better VA.|Baseline, Week 52, and Week 104|ITT Population. The number analyzed reflects those participants remaining in the study and contributing data at the indicated time points.||scores on a scale||Standard Deviation|Mean
765865|NCT00682643|Secondary|Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 104|An event for IOP is defined as an increase of 7 mm Hg or greater from baseline in IOP, in either eye, using Goldmann Applanation Tonometry. Participants without post-baseline ophthalmic exam data were censored at the randomization date. Change from baseline in IOP was calculated by subtracting the baseline value from the Week 104 value.|Baseline and Week 104|ITT Population. The number analyzed reflects those participants remaining in the study and contributing data at the indicated time points.||participants|||Number
765866|NCT00682643|Secondary|Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 52|An event for IOP is defined as an increase of 7 mm Hg or greater from baseline in IOP, in either eye, using Goldmann Applanation Tonometry. Participants without post-baseline ophthalmic exam data were censored at the randomization date. Change from baseline was calculated by subtracting the baseline value from the Week 52 value.|Baseline and Week 52|ITT Population. The number analyzed reflects those participants remaining in the study and contributing data at the indicated time points.||participants|||Number
765867|NCT00682643|Secondary|Change From Baseline in Intraocular Pressure (IOP) at Weeks 52 and 104|An event for IOP is defined as an increase of 7 mm Hg or greater from baseline in IOP, in either eye, using Goldmann Applanation Tonometry. Participants without post-baseline ophthalmic exam data were censored at the randomization date. Change from baseline was calculated by subtracting the baseline value from the Week 52 or Week 104 value.|Baseline, Week 52, and Week 104|ITT Population. The number analyzed reflects those participants remaining in the study and contributing data at the indicated time points.||mm Hg||Standard Deviation|Mean
765868|NCT00682643|Secondary|Change From Baseline in Nuclear Color (NC) at Week 52 and Week 104|Nuclear color is associated with the force required to compress a lens to 75% of its original depth. The range for NC is 0.1 (no opacity) to 6.9 (maximum opacity). Change from baseline in NC was calculated by subtracting the baseline value from the Week 52 or Week 104 value.|Baseline, Week 52, and Week 104|ITT Population. The number analyzed reflects those participants remaining in the study and contributing data at the indicated time points.||scores on a scale||Standard Deviation|Mean
765869|NCT00682643|Secondary|Change From Baseline in LOCS III Nuclear Opacity (NO) at Week 52 and Week 104|Nuclear opacity refers to the opacity in the central nucleus of the eye.The range for NO is 0.1 (no opacity) to 6.9 (maximum opacity). Change from baseline in NO was calculated by subtracting the baseline value from the Week 52 or Week 104 value.|Baseline, Week 52, and Week 104|ITT Population. The number analyzed reflects those participants remaining in the study and contributing data at the indicated time points.||scores on a scale||Standard Deviation|Mean
765870|NCT00682643|Secondary|Number of Participants With the Indicated Change From Baseline in Cortical Opacity by Increment Categories of >=0.3, >=0.5, and >=1.0 at Weeks 52 and 104|An event for C (an opacity starting at the outer edge of the lens and progressing toward the center) is defined as an increase of >=0.3 from baseline in LOCS III (system used for the grading and comparison of cataract severity and type based on standard color photographic transparencies) grade for C (range=0.1 [lens clear] to 5.9 [lens unclear]), in either eye. Change from baseline was calculated by subtracting the baseline value from the Week 52 and Week 104 value.|Baseline, Week 52, and Week 104|ITT Population. The number analyzed reflects those participants remaining in the study and contributing data at the indicated time points.||participants|||Number
765871|NCT00682643|Secondary|Change From Baseline in LOCS III Cortical Opacity (C) at Week 52 and Week 104|An event for C (an opacity starting at the outer edge of the lens and progressing toward the center) is defined as an increase of >=0.3 from baseline in LOCS III (system used for the grading and comparison of cataract severity and type based on standard color photographic transparencies) grade for C (range=0.1 [lens clear] to 5.9 [lens unclear]), in either eye. Change from baseline was calculated by subtracting the baseline value from the Week 52 and Week 104 value.|Baseline, Week 52, and Week 104|ITT Population. The number analyzed reflects those participants remaining in the study and contributing data at the indicated time points.||scores on a scale||Standard Deviation|Mean
765872|NCT00682643|Secondary|Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104|An event for P is defined as an increase of >=0.3 from baseline in LOCS III (classification system based on standard color photographic transparencies) grade for P (range=0.1 [lens clear] to 5.9 [lens unclear]), in either eye. Change from baseline was calculated by subtracting the baseline value from the Week 52 and Week 104 value.|Baseline, Week 52, and Week 104|ITT Population. The number analyzed reflects those participants remaining in the study and contributing data at the indicated time points.||participants|||Number
765873|NCT00682643|Secondary|Change From Baseline in LOCS III Posterior Subcapsular Opacity at Week 52 and Week 104|An event for P (opacity in the lens positioned just anterior to the posterior lens capsule and characterized by the posterior migration of lens epithelial cells from the lens bow) is defined as an increase of >=0.3 from baseline in LOCS III (system used for the grading and comparison of cataract severity and type based on standard color photographic transparencies) grade for P (range=0.1 [lens clear] to 5.9 [lens unclear]), in either eye. Change from baseline was calculated by subtracting the baseline value from the Week 52 and Week 104 value.|Baseline, Week 52, and Week 104|ITT Population. The number analyzed reflects those participants remaining in the study and contributing data at the indicated time points.||scores on a scale||Standard Deviation|Mean
765874|NCT00682643|Primary|Cumulative Proportion of Participants, as Measured as a Percentage, With an Intraocular Pressure (IOP) Event|An event for IOP is defined as an increase of 7 millimeters of mercury (mm Hg) or greater from baseline in IOP, in either eye, using Goldmann Applanation Tonometry (GAT). GAT is a commonly used method of determining approximate intraocular pressure. The data below represent the Kaplan-Meier estimate for the cumulative proportion of participants with an IOP event based on a lifetest table.|Baseline; Weeks 12, 24, 36, 52, 64, 76, 88, and 104|ITT Population. All participants with post-baseline ophthalmic examination data were included in the analysis for this endpoint.||percentage of participants|||Number
765875|NCT00682643|Primary|Cumulative Proportion (CU) of Participants (Par.) With an Event, as Measured as a Percentage, for Posterior Subcapsular Opacity (P)|An event for P (opacity in the lens positioned just anterior to the posterior lens capsule and characterized by the posterior migration of lens epithelial cells from the lens bow) is defined as an increase of >=0.3 from baseline in Lens Opacities Classification System, Version III (LOCS III; system used for the grading and comparison of cataract severity and type based on standard color photographic transparencies) grade for P (range=0.1 [lens clear] to 5.9 [lens unclear]), in either eye. Data represent the Kaplan-Meier estimate for the CU of par. with an event of P based on a lifetest table.|Baseline; Weeks 12, 24, 36, 52, 64, 76, 88, and 104|ITT Population. All participants (par.) with post-baseline ophthalmic examination data were included in the analysis for this endpoint. Par. without post-baseline ophthalmic exam data were censored at the randomization data. Par. who completed the study without an event for P or were discontinued for reasons other than an event for P were censored.||Percentage of participants|||Number
765876|NCT00682734|Primary|Pain Intensity Score|Change in 11 point pain intensity score between baseline and one hour. At both baseline and one hour, all patients were asked to describe their pain on a scale from 0 to 10, with 0 signifying no pain and 10 signifying the worst pain imaginable. Therefore, the CHANGE in pain score could range from -10 through 10.|Baseline, 60 minutes|per protocol||scores on a scale||Standard Deviation|Mean
765877|NCT00682786|Post-Hoc|Associations Between MTHFR Diplotypes and Grade 3-4 Diarrhea and/or Mucositis (Poor Risk Group)|Genomic DNA was isolated from whole blood using the Puregene DNA isolation kit.|First day of treatment through 30 days after completion of surgery|2 of the patients in the Poor Risk arm withdrew consent and are not included.||participants|||Number
765878|NCT00682786|Post-Hoc|Associations Between MTHFR Diplotypes and Grade 3-4 Diarrhea and/or Mucositis (Good Risk Group)|Genomic DNA was isolated from whole blood using the Puregene DNA isolation kit.|First day of treatment through 30 days after completion of surgery|2 of the patients in the Good Risk arm withdrew consent and are not included.||participants|||Number
765879|NCT00682786|Post-Hoc|Associations Between MTHFR Haplotypes and Grade 3-4 Diarrhea and/or Mucositis (Poor Risk Group)|Genomic DNA was isolated from whole blood using the Puregene DNA isolation kit.|First day of treatment through 30 days after completion of surgery|2 of the patients in the Poor Risk arm withdrew consent and are not included.||participants|||Number
765880|NCT00682786|Post-Hoc|Associations Between MTHFR Haplotypes and Grade 3-4 Diarrhea and/or Mucositis (Good Risk Group)|Genomic DNA was isolated from whole blood using the Puregene DNA isolation kit.|First day of treatment through 30 days after completion of surgery|2 of the patients in the Good Risk arm withdrew consent and are not included.||participants|||Number
765881|NCT00682786|Post-Hoc|Associations Between MTHFR Genotypes and Grade 3-4 Diarrhea and/or Mucositis (Poor Risk Group)|Genomic DNA was isolated from whole blood using the Puregene DNA isolation kit.|First day of treatment through 30 days after completion of surgery|2 of the patients in the Poor Risk arm withdrew consent and are not included.||participants|||Number
775449|NCT00756977|Secondary|Serum Chemistry Results (g/dL)|Change from Baseline|2 days|Intent-to-treat population: all patients that took any portion of the study preparation.||g/dL||Standard Deviation|Mean
765884|NCT00682786|Post-Hoc|Associations Between MTHFR Genotypes and Grade 3-4 Diarrhea and/or Mucositis (Good Risk Group)|"Genomic DNA was isolated from whole blood using the Puregene DNA isolation kit.
MTHFR gene = methylenetetrahydrofolate reductase (NAD(P)H)"|First day of treatment through 30 days after completion of surgery|2 of the patients in the Good Risk arm withdrew consent and are not included.||participants|||Number
765885|NCT00682786|Post-Hoc|Relapse-free Survival|Analyzed using Kaplan-Meier Models.|1 year, 2 years, and 3 years|"14 patients in the Good Risk arm had metastatic rectal cancer at time of enrollment are not included in this analyses.
3 patients in the Poor Risk arm had metastatic rectal disease before surgery and are included in this analyses.
2 of the patients in the Good Risk arm and Poork Risk arm withdrew consent and are not included."||percentage of participants|||Number
765886|NCT00682786|Post-Hoc|Overall Survival|Analyzed using Kaplan-Meier Models.|1 year, 2 years, and 3 years|Two of the patients in the Good Risk arm withdrew consent and are not included. Two of the patients in the Poor Risk arm withdrew consent and are not included.||percentage of participants|||Number
765887|NCT00682786|Post-Hoc|Toxicities by Genotype Group (Good Risk Versus Poor Risk)|Grade 3 to 4 toxicities related to treatment and surgery using CTC Version 2.0.|First day of treatment through 30 days after completion of surgery|Two of the patients in the Good Risk arm withdrew consent and are not included. Two of the patients in the Poor Risk arm withdrew consent and are not included.||participants|||Number
765888|NCT00682786|Secondary|Determine Patient Fears and Expectations of Pharmacogenetics.|The questionnaire is encouraged but not required.|Prior to start of study treatment and 3-6 weeks post completion of radiation therapy|The data was not collected for this outcome measure as the questionnaire was encouraged but not required.|||||
765889|NCT00682786|Secondary|Define Patient Quality of Life Prior to and Following Neoadjuvant Chemoradiation.|The questionnaire is encouraged but not required.|Prior to start of study treatment and 3-6 weeks post completion of radiation therapy|The data was not collected for this outcome measure as the questionnaire was encouraged but not required.|||||
765890|NCT00682786|Secondary|Complete Response Rates|"Complete tumor response is defined as the absence of any viable tumor in the rectum (ypT0).
Pathologic complete response (pCR) is defined as the absence of any viable tumor in the rectum or in the perirectal lymph nodes (ypT0N0).
pCR rate of historical controls is 8%-14%."|1 year after enrollment|"8 not evaluable in Good Risk arm-(1)death before surgery (1)clinical CR w/o surgery (1)refused surgery (2)not resectable (2)withdrew consent (1)delayed surgery and given FOLFOX
6 not evaluable in Poor Risk arm-(1) death prior to surgery (1)clinical CR no surgery (1)refused surgery (2)withdrew consent (1)not given irinotecan by treating physician"||percentage of participants|||Number
765891|NCT00682786|Primary|Rate of Tumor Downstaging Compared With Historical Controls.|"Tumor downstaging (DS) is defined as a decrease in the T stage of the primary tumor by at least 1.
Historical studies demonstrate a DS rate of 45%."|1 year after enrollment|"8 not evaluable in Good Risk arm-(1)death before surgery (1)clinical CR w/o surgery (1)refused surgery (2)not resectable (2)withdrew consent (1)delayed surgery and given FOLFOX
6 not evaluable in Poor Risk arm-(1) death prior to surgery (1)clinical CR no surgery (1)refused surgery (2)withdrew consent (1)not given irinotecan by treating physician"||percentage of participants||95% Confidence Interval|Number
765892|NCT00682838|Primary|Nightly CPAP Adherence|Nightly CPAP adherence hours per night measured over the three-months period|3 mos|||hours per night||Standard Deviation|Mean
765893|NCT00682851|Secondary|Specificity of the BVBlue Test and Amsel Criteria in Diagnosing BV in Symptomatic and Asymptomatic Women.|Specificity of the BVBlue Test and Amsel criteria in diagnosing BV using Gram Stain (Nugent scoring) as the gold standard in symptomatic and asymptomatic women. The specificity of a test is the percentage of people who do not have the infection (as diagnosed by the gold standard method) among those who have a negative test.|Visit 1|||Percentage of Participants||95% Confidence Interval|Number
765894|NCT00682851|Secondary|Sensitivity of the BVBlue Test and Amsel Criteria in Diagnosing Bacterial Vaginosis in Symptomatic and Asymptomatic Women.|Sensitivity of the BVBlue Test and Amsel criteria in diagnosing bacterial vaginosis using Gram Stain (Nugent scoring) as the gold standard in symptomatic and asymptomatic women. The sensitivity of a test is the percentage of people who have the infection (as diagnosed by the gold standard method) among those who have a positive test.|Visit 1|||Percentage of Participants||95% Confidence Interval|Number
765895|NCT00682851|Secondary|Specificity of the OSOM Rapid Test and PCR Wet Mount Microscopy in Diagnosing Trichomonas Vaginalis in Symptomatic and Asymptomatic Women|Specificity of the OSOM Rapid test and PCR wet mount microscopy in diagnosing Trichomonas vaginalis using Trichomonas culture as the gold standard in symptomatic and asymptomatic women. The specificity of a test is the percentage of people who do not have the infection (as diagnosed using the gold standard method) among those who have a negative test.|Visit 1|||Percentage of Participants||95% Confidence Interval|Number
765896|NCT00682851|Primary|Sensitivity of the OSOM Rapid Test and PCR Wet Mount Microscopy in Diagnosing Trichomonas Vaginalis in Symptomatic and Asymptomatic Women|Sensitivity of the OSOM Rapid test and PCR wet mount microscopy in diagnosing Trichomonas vaginalis using Trichomonas culture as the gold standard in symptomatic and asymptomatic women. The sensitivity of a test is the percentage of people who have the infection (as diagnosed by the gold standard method) among those who have a positive test.|Visit 1|||Percentage of Participants||95% Confidence Interval|Number
765897|NCT00682890|Primary|Change in Insulin Sensitivity Measures: Insulin Sensitivity (SI)|Insulin sensitivity as measured by a combination of insulin sensitivity index (ISI) which should go up after 3 month treatment period to show improvement, and insulin sensitivity (SI) which should go down after 3 month treatment period to show improvement. Note that the ISI as developed by Matsuda and DeFronzo from a calculation based on results from a standard oral glucose tolerance test (OGTT) (doi: 10.2337/diacare.22.9.1462 Diabetes Care September 1999 vol. 22 no. 9 1462-1470) is recorded as units on an arbitrary scale. SI data is based on a calculation derived from analysis of results of frequently sampled intravenous glucose tolerance test (FSIVGTT) by Bergman et al (doi:10.1172/JCI112886/J Clin Invest. 1987;79(3):790–800) and is reported with units min-1/(µlU/L).|baseline and 3 months|||min-1/(µlU/L)||Standard Deviation|Mean
765911|NCT00683046|Secondary|Median Overall Survival|"All patients were administered the following drugs;
Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3
Melphalan 140mg/m2 IV on day -2
Stem cell infusion on day 0
Campath 20mg IV on day -7,-6,-5,-4, and -3"|Patients evaluated continuously with disease specific re-evaluation at day 30, 3 months, 6 months, 1 year, and as indicated thereafter up to 10 years|||Days||95% Confidence Interval|Median
765898|NCT00682890|Primary|Change in Insulin Sensitivity Measures: Insulin Sensitivity Index (ISI)|Insulin sensitivity as measured by a combination of insulin sensitivity index (ISI) which should go up after 3 month treatment period to show improvement, and insulin sensitivity (SI) which should go down after 3 month treatment period to show improvement. Note that the ISI as developed by Matsuda and DeFronzo from a calculation based on results from a standard oral glucose tolerance test (OGTT) (doi: 10.2337/diacare.22.9.1462 Diabetes Care September 1999 vol. 22 no. 9 1462-1470) is recorded as units on an arbitrary scale. SI data is based on a calculation derived from analysis of results of frequently sampled intravenous glucose tolerance test (FSIVGTT) by Bergman et al (doi:10.1172/JCI112886/J Clin Invest. 1987;79(3):790–800) and is reported with units min-1/(µlU/L).|baseline and 3 months|||units on a scale||Standard Deviation|Mean
765899|NCT00683020|Secondary|Changes in Diastolic Blood Pressure (DBP)|Diastolic blood pressure is the pressure exerted on the walls of the arteries and vessels in between heart beats, when the heart is relaxed and dilated, filling with blood. Change is calculated as 6-month pressure minus baseline pressure.|Baseline and 6 months|The Participant Flow Module numbers are the numbers of participants in the particular categories of the module. However, the number of participants analyzed counts only those participants who have both baseline and 6-month follow-up outcome data.||mm Hg||Standard Error|Least Squares Mean
765900|NCT00683020|Secondary|Changes in Systolic Blood Pressure (SBP)|Systolic blood pressure is the pressure exerted on arteries and vessels by the heart when it contracts and pushes blood through the arteries to the rest of the body. Change is calculated as 6-month pressure minus baseline pressure.|Baseline and 6 months|The Participant Flow Module numbers are the numbers of participants in the particular categories of the module. However, the number of participants analyzed counts only those participants who have both baseline and 6-month follow-up outcome data.||mm Hg||Standard Error|Least Squares Mean
765901|NCT00683020|Secondary|Changes in Hemoglobin A1c Levels|Hemoglobin A1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. As the average amount of plasma glucose increases, the fraction of hemoglobin A1c increases in a predictable way. This serves as a marker for average blood glucose levels over the previous months prior to the measurement. Higher amounts of hemoglobin A1c indicate poorer control of blood glucose levels and have been associated with cardiovascular disease. Change is calculated as 6-month level minus baseline level.|Baseline and 6 months|The Participant Flow Module numbers are the numbers of participants in the particular categories of the module. However, the number of participants analyzed counts only those participants who have both baseline and 6-month follow-up outcome data.||percentage||Standard Error|Least Squares Mean
765902|NCT00683020|Secondary|Changes in Patient-centeredness of Care as Measured by Interpersonal Processes of Care (IPC) Scale|The Interpersonal Processes of Care (IPC) is an 18-item patient report instrument that measures patients’ perspectives on the structure of their care and collects patient reports on providers’ communication over the prior 6 months. The scale is intended to measure patients’ assessment of providers’ communication within 3 broad domains: communication (e.g., lack of clarity), decision making (e.g., patient-centered decision making), and interpersonal style (e.g., friendliness). Each instrument item is scored on a 5-point scale ranging from 1 to 5. Scores are transformed to a 100-point scale and averaged across all items to create a total scale score. Higher total scores indicate better communication. Change is calculated as 6-month score minus baseline score.|Baseline and 6 months|The Participant Flow Module numbers are the numbers of participants in the particular categories of the module. However, the number of participants analyzed counts only those participants who have both baseline and 6-month follow-up outcome data.||units on a scale||Standard Error|Least Squares Mean
765903|NCT00683020|Secondary|Changes in Patient-centeredness of Care as Measured by Patient Assessment of Chronic Illness Care (PACIC) Scale|The Patient Assessment of Chronic Illness Care (PACIC) is a 20-item patient report instrument that measures patients’ perspectives on the structure of their care and collects patient reports on the extent to which they have received specific clinical services and actions during the past 6 months that are aligned with the Chronic Care Model. The scale is intended to assess the receipt of care that is patient-centered, proactive, planned and includes collaborative goal setting, problem-solving and follow-up support. Each instrument item is scored on a 5-point scale ranging from 1 to 5 with higher score indicating better care. Scores are transformed to a 100-point scale (0-100) and averaged across all items to create a total scale score. Higher transformed and total scale scores indicate better care. Change is calculated as 6-month score minus baseline score.|Baseline and 6 months|The Participant Flow Module numbers are the numbers of participants in the particular categories of the module. However, the number of participants analyzed counts only those participants who have both baseline and 6-month follow-up outcome data.||units on a scale||Standard Error|Least Squares Mean
765904|NCT00683020|Secondary|Changes in Diabetes Self-efficacy as Measured by Diabetes Quality Improvement Project's Patient Self-Management Scale|The Patient Self-Management Scale was derived from a questionnaire used in the Diabetes Quality Improvement Project. The scale is designed to reflect patients’ assessment of their ability to manage aspects of diabetes self-care in 5 separate areas (medication, diet, exercise, blood glucose monitoring, and foot care). Respondents are asked how difficult over the past 6 months has it been to follow exactly as their doctor who takes care of their diabetes suggested. Possible scores for each scale item range from 0 to 100 with higher score indicating more self-efficacy. Total scale score is calculated as the average across all items. Change is calculated as 6-month score minus baseline score.|Baseline and 6 months|The Participant Flow Module numbers are the numbers of participants in the particular categories of the module. However, the number of participants analyzed counts only those participants who have both baseline and 6-month follow-up outcome data.||units on a scale||Standard Error|Least Squares Mean
765912|NCT00683046|Primary|Median Disease-free Survival|"All patients were administered the following drugs;
Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3
Melphalan 140mg/m2 IV on day -2
Stem cell infusion on day 0
Campath 20mg IV on day -7,-6,-5,-4, and -3"|Patients evaluated continuously with disease specific re-evaluation at day 30, 3 months, 6 months, 1 year, and as indicated thereafter up to 10 years|||Days||95% Confidence Interval|Median
765913|NCT00683085|Secondary|Number of Participants With Tumor Regression|Sum of diameters of primary pancreatic tumor or metastatic tumors (target lesions) before and after vaccination were measured by computed tomography. Sum of tumors' size diameters decrease more than 30% after vaccination was diagnosed as response according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 guidelines.|2 months|intension to treat (ITT)||participants|||Number
765905|NCT00683020|Secondary|Changes in Self-reported Medication Adherence as Measured by Summary of Diabetes Self-Care Activities (SDSCA) Scale|The Summary of Diabetes Self-Care Activities (SDSCA) Measure is a brief self-report questionnaire on diabetes self-management behaviors. The questionnaire assesses the frequency with which a patient followed a diabetes routine over the prior 7 days in five domains: diet, exercise, blood-glucose testing, foot care, and medication adherence. Based on SDSCA measure’s author’s recommendations, two separate scores are derived: a Diabetes Self-management Behaviors score and a Self-reported Medication Adherence score. For the Diabetes Self-management Behaviors score, all items pertaining to diet, exercise, blood glucose testing, and foot care are averaged. For the Self-reported Medication Adherence score, all items pertaining to medication use are averaged. For both scores, the result is an average score between 0 and 7 with higher score indicating better diabetes self-management behavior or better medication adherence. Change is calculated as 6-month score minus baseline score.|Baseline and 6 months|The Participant Flow Module numbers are the numbers of participants in the particular categories of the module. However, the number of participants analyzed counts only those participants who have both baseline and 6-month follow-up outcome data.||units on a scale||Standard Error|Least Squares Mean
765906|NCT00683020|Secondary|Changes in Diabetes Self-management Behaviors as Measured by Summary of Diabetes Self-Care Activities (SDSCA) Scale|The Summary of Diabetes Self-Care Activities (SDSCA) Measure is a brief self-report questionnaire on diabetes self-management behaviors. The questionnaire assesses the frequency with which a patient followed a diabetes routine over the prior 7 days in five domains: diet, exercise, blood-glucose testing, foot care, and medication adherence. Based on SDSCA measure’s author’s recommendations, two separate scores are derived: a Diabetes Self-management Behaviors score and a Self-reported Medication Adherence score. For the Diabetes Self-management Behaviors score, all items pertaining to diet, exercise, blood glucose testing, and foot care are averaged. For the Self-reported Medication Adherence score, all items pertaining to medication use are averaged. For both scores, the result is an average score between 0 and 7 with higher score indicating better diabetes self-management behavior or better medication adherence. Change is calculated as 6-month score minus baseline score.|Baseline and 6 months|The Participant Flow Module numbers are the numbers of participants in the particular categories of the module. However, the number of participants analyzed counts only those participants who have both baseline and 6-month follow-up outcome data.||units on a scale||Standard Error|Least Squares Mean
765907|NCT00683020|Secondary|Proportion of Patients Reporting Diabetes Interference of Normal Daily Activities|A measure of diabetes interference on patients is ascertained by asking patients the following question: “In the last 6 months, how often has your diabetes kept you from doing your normal daily activities, such as going to work, grocery shopping, and taking care of yourself and others?” Responses consist of 6 possible options: “Always”, “Almost Always”, “Often”, “Sometimes”, “Almost Never”, and “Never”. These responses are grouped into 2 categories, with one category consisting of “Always”, “Almost Always”, and “Often” responses while the other category consists of the remaining responses. The proportion of patients reporting diabetes interference is the number of patients in the first category divided by the number of patients in the 2 categories combined.|6 months|The Participant Flow Module numbers are the numbers of participants in the particular categories of the module. However, the number of participants analyzed counts only those participants who have both baseline and 6-month follow-up outcome data.||proportion of patients|||Number
765908|NCT00683020|Secondary|Number of Days Spent in Bed Due to Illness|A measure of patients’ functional status is ascertained by asking patients the following question: “In the last 30 days, how many days did health problems keep you in bed for all or most of the day?” Number of days may range from 0 to 30, with lower number of days indicating better functional status. Because a negative binomial model was used to analyze the data for number of days spent in bed due to illness, log means are reported. A log mean is the natural (base e) logarithm of the mean (in this context specifically, the mean number of days spent in bed due to illness). To calculate the mean, one raises e by the number given as the log mean. Lower log means indicate better functional status.|6 months|The Participant Flow Module numbers are the numbers of participants in the particular categories of the module. However, the number of participants analyzed counts only those participants who have both baseline and 6-month follow-up outcome data.||log days||95% Confidence Interval|Mean
765909|NCT00683020|Primary|Changes in the Mental Component Summary of the SF-12 Health Survey|The SF-12 Health Survey (SF-12) is a 12-item short-form survey used to measure health status and monitor health outcomes. The survey asks about various health aspects, including physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health (psychological distress and psychological well-being). Two summary measures are derived: the Physical and the Mental Health Component Summary. For each component summary, survey items were weighted and summed to create a summary score between 0 and 100 with higher score indicating better functioning and outcome. Change is calculated as 6-month score minus baseline score.|Baseline and 6 months|The Participant Flow Module numbers are the numbers of participants in the particular categories of the module. However, the number of participants analyzed counts only those participants who have both baseline and 6-month follow-up outcome data.||units on a scale||Standard Error|Least Squares Mean
765910|NCT00683020|Primary|Changes in the Physical Component Summary of the SF-12 Health Survey|The SF-12 Health Survey (SF-12) is a 12-item short-form survey used to measure health status and monitor health outcomes. The survey asks about various health aspects, including physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health (psychological distress and psychological well-being). Two summary measures are derived: the Physical and the Mental Health Component Summary. For each component summary, survey items were weighted and summed to create a summary score between 0 and 100 with higher score indicating better functioning and outcome. Change is calculated as 6-month score minus baseline score.|Baseline and 6 months|The Participant Flow Module numbers are the numbers of participants in the particular categories of the module. However, the number of participants analyzed counts only those participants who have both baseline and 6-month follow-up outcome data.||units on a scale||Standard Error|Least Squares Mean
766192|NCT00685659|Primary|Percent Days Cocaine Use|Percent of days during the follow up that there was any cocaine use|3 months (approximately study days 1 - 90)|N's represent the participants at three months for whom complete Time Line Follow Back data was available.||percentage of days||Standard Error|Mean
765914|NCT00683085|Primary|Number of Participants Without Grade 4 Hematological or Grade 3 to 4 Non-hematological Adverse Events|Number of participants without grade 4 hematological or grade 3 other adverse events were caslculated based on the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (NCI CTCAE v.3)|2 months|Intention to treat (ITT)||participants|||Number
765915|NCT00683163|Secondary|Change From Baseline in Trabecular Spine vBMD|Areal bone mineral density (aBMD) at the lumbar spine, hip, and distal one-third radius was assessed by dual-energy X-ray absorption at baseline and 6, 12, 18, and 24 months. The precision for aBMD is 1.0%. Volumetric BMD and bone geometry in trabecular and cortical compartments were assessed by quantitative computed tomography (QCT) at the spine and hip. The left hip was used for analysis. The precision for trabecular spine vBMD measurement is 1.0%. Trabecular spine vBMD was our primary BMD outcome, thus the one presented here.|Baseline, 24 months.|||Percent change from baseline||Standard Deviation|Mean
765916|NCT00683163|Primary|P1NP (ng/ml) Change From Baseline.|After an overnight fast, serum was drawn at baseline and 1, 3, 6, 12, 15, 18 and 24 months. Samples were stored at -70C until batch assayed in a central laboratory. Serum N-propeptide of type I collagen (P1NP) and C-terminal telopeptide of type I collagen (CTX) were measured by electrochemiluminescent immunoassay. Bone-specified alkaline phosphate (BAP) was measured by paramagnetic particle immunoassay. P1NP was the bone turnover marker upon which we based sample size calculations.|Baseline, 3 months|Analyses were performed according to intention-to-treat principle. A sample size of 20 participants per group was estimated to provide 80% power to detect a change of 25ng/mL in PINP, assuming the SD of 40ng/mL observed previously with concurrent PTH(1-84) and daily alendronate.||Percent change from baseline||95% Confidence Interval|Geometric Mean
765917|NCT00683293|Secondary|Complications||up to 2 weeks|||participants|||Number
765918|NCT00683293|Primary|Duration of Surgery|•Mean Time to complete surgery from cut to suture|after surgey|||minutes||Standard Deviation|Mean
765919|NCT00683332|Primary|Number of Participants With Spontaneous Adverse Events|"Adverse events were based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participant. In addition to the information obtained from these sources, the participant was asked the following nonspecific question: How have you been feeling since your last visit?"|30 days post injection up to 3 years|Safety Population: All participants who received at least 1 dose of tygacil||Participants|||Number
765920|NCT00683384|Primary|Number of Participants With Spontaneous Adverse Events Reported Until 30 Days After Each Injection||30 days post injection up to 3 years|Full analysis set||Participants|||Number
765921|NCT00683410|Primary|Number of Participants With Spontaneous Adverse Events||30 days post injection up to 3 years|Safety Analysis set - all participants who received at least one dose of Prevenar||Participants|||Number
765922|NCT00683449|Secondary|Hospital Admission Rate During Visit 1|After a patient in the emergency department (ED) presents with an acute exacerbation of asthma, the hospital proceeds with SOC procedures for this condition. Despite treatment in the ED, it is sometimes necessary to admit the patient into the hospital. In the study described here, the rate of hospital admissions was recorded.|Hour -1.5 through Hour 5|||participants|||Number
765923|NCT00683449|Secondary|FEV1 (L) The Forced Expiratory Volume in One Second as Measured in Liters Per Second.|FEV1 (L) was determined over time using a spirometer. Measure the mean change in FEV1 (L) from Baseline.|Baseline to Hour 2|29 subjects experiencing an acute exacerbation of asthma were at approximately 8 ED sites. The sample size was based on feasibility and precedent for this type of study, rather than statistical considerations.||liters per second||Full Range|Mean
765924|NCT00683449|Primary|Change of FEV1 (Forced Expiratory Volume in 1 Second) Expressed as Percent of Predicted After Two Doses of Albuterol (5 mg Each) and Ipratropium (0.5 mg Each) When Compared to FEV1 at Hour 2 After the Start of the Infusion of MN-221 or Placebo.|The primary efficacy summary was change from Baseline in FEV1 (percent predicted), at Hour 2. Baseline was defined as FEV1 (percent predicted) after two doses of albuterol (5 mg each) and ipratropium (0.5 mg each) and FEV1 (percent predicted) FEV1 at Hour 2 was defined as the FEV1 (percent predicted) at 2 hours after the start of the infusion of MN-221 or placebo. Change from Baseline in FEV1 (percent predicted), was summarized by treatment group at Hour 2.|Baseline and Hour 2|The analysis was performed on the Intention-to-Treat (ITT) population. Twenty-nine subjects met the study entry criteria, provided written informed consent, and were enrolled in the study.||FEV1 (percent of predicted)||Full Range|Mean
765925|NCT00683475|Secondary|Minimum Concentration (Cmin) at Study Day 30|"Minimum concentration (Cmin) of Ramucirumab.
All samples were assayed 36 months post sample collection, which exceeds the established long-term serum stability period for ramucirumab. Therefore, concentration data were invalid and pharmacokinetic (PK) analyses could not be conducted."|Day 30|Zero participants were analyzed.|||||
765926|NCT00683475|Secondary|Minimum Concentration (Cmin) at Study Day 16|"Minimum concentration (Cmin) of Ramucirumab.
All samples were assayed 36 months post sample collection, which exceeds the established long-term serum stability period for ramucirumab. Therefore, concentration data were invalid and pharmacokinetic (PK) analyses could not be conducted."|Day 16|Zero participants were analyzed.|||||
765927|NCT00683475|Secondary|Minimum Concentration (Cmin) at Study Day 15|"Minimum concentration (Cmin) of Ramucirumab.
All samples were assayed 36 months post sample collection, which exceeds the established long-term serum stability period for ramucirumab. Therefore, concentration data were invalid and pharmacokinetic (PK) analyses could not be conducted."|Day 15|Zero participants were analyzed.|||||
765928|NCT00683475|Secondary|Minimum Concentration (Cmin) at Study Day 1|"Minimum concentration (Cmin) of Ramucirumab.
All samples were assayed 36 months post sample collection, which exceeds the established long-term serum stability period for ramucirumab. Therefore, concentration data were invalid and pharmacokinetic (PK) analyses could not be conducted."|Day 1|Zero participants were analyzed.|||||
765929|NCT00683475|Secondary|Maximum Concentration (Cmax) at Study Day 30|"Maximum concentration (Cmax) of Ramucirumab.
All samples were assayed 36 months post sample collection, which exceeds the established long-term serum stability period for ramucirumab. Therefore, concentration data were invalid and pharmacokinetic (PK) analyses could not be conducted."|Day 30|Zero participants were analyzed.|||||
765930|NCT00683475|Secondary|Maximum Concentration (Cmax) at Study Day 16|"Maximum concentration (Cmax) of Ramucirumab.
All samples were assayed 36 months post sample collection, which exceeds the established long-term serum stability period for ramucirumab. Therefore, concentration data were invalid and pharmacokinetic (PK) analyses could not be conducted."|Day 16|Zero participants were analyzed.|||||
765931|NCT00683475|Secondary|Maximum Concentration (Cmax) at Study Day 15|"Maximum concentration (Cmax) of Ramucirumab.
All samples were assayed 36 months post sample collection, which exceeds the established long-term serum stability period for ramucirumab. Therefore, concentration data were invalid and pharmacokinetic (PK) analyses could not be conducted."|Day 15|Zero participants were analyzed.|||||
765932|NCT00683475|Secondary|Maximum Concentration (Cmax) at Study Day 1|"Maximum Concentration (Cmax) of Ramucirumab.
All samples were assayed 36 months post sample collection, which exceeds the established long-term serum stability period for ramucirumab. Therefore, concentration data were invalid and pharmacokinetic (PK) analyses could not be conducted."|Day 1|Zero participants were analyzed.|||||
765933|NCT00683475|Secondary|Objective Response Rate (ORR)|"Objective response is Complete Response (CR) + Partial Response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is a disappearance of all target and non-target lesions; PR is at least a 30% decrease in the sum of the longest diameter of target lesions without new lesions and progression of non-target lesions.
Objective response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with measurable disease, multiplied by 100."|Baseline to date of progressive disease or death up to 36.3 months|Participants with measurable disease at baseline, who received any quantity of study drug.||percentage of participants||95% Confidence Interval|Number
765934|NCT00683475|Secondary|Overall Survival (OS)|Overall survival is defined as the time from randomization to the date of death due to any cause. Participants who were alive at the time of study completion were censored at the time the participant was last known to be alive.|First dose to death due to any cause up to 36.3 months|"Modified intent to treat population (mITT): All participants who received any quantity of study drug.
Nine participants were censored in the IMC-A12 + Mitoxantrone + Prednisone arm. Twelve participants were censored in the IMC-1121B + Mitoxantrone + Prednisone arm"||months||95% Confidence Interval|Median
765935|NCT00683475|Secondary|Composite Progression-free Survival (cPFS) at 12-months|"Data presented are the percentage of participants without disease progression at 12 months.
Participants who were ongoing with no progression or who discontinued treatment for reasons other than progression were censored at date of last assessment. Participants who started new anticancer treatment before progression were censored at date of last assessment before start of new anti-cancer therapy."|12 months|Modified intent to treat population (mITT): All participants who received any quantity of study drug.||percentage of participants||95% Confidence Interval|Number
765936|NCT00683475|Secondary|Composite Progression-free Survival (cPFS) at 9-months|"Data presented are the percentage of participants without disease progression at 9 months.
Participants who were ongoing with no progression or who discontinued treatment for reasons other than progression were censored at date of last assessment. Participants who started new anticancer treatment before progression were censored at date of last assessment before start of new anti-cancer therapy."|9 months|Modified intent to treat population (mITT): All participants who received any quantity of study drug.||percentage of participants||95% Confidence Interval|Number
765937|NCT00683475|Secondary|Composite Progression-free Survival (cPFS) at 6-months|"Data presented are the percentage of participants without disease progression at 6 months.
Participants who were ongoing with no progression or who discontinued treatment for reasons other than progression were censored at date of last assessment. Participants who started new anticancer treatment before progression were censored at date of last assessment before start of new anti-cancer therapy."|6 months|Modified intent to treat population (mITT): All participants who received any quantity of study drug.||percentage of participants||95% Confidence Interval|Number
765938|NCT00683475|Secondary|Prostate Specific Antigen (PSA) Response Rate|PSA response rate is defined as the percentage of participants with a decrease in PSA >= 50 percent from baseline.|Baseline up to data cut-off date (up to 36.3 months)|Participants who received any quantity of study drug, had baseline PSA value >= 2 ng/ml and at least one non-missing post-baseline PSA.||percentage of participants||95% Confidence Interval|Number
765939|NCT00683475|Secondary|Time to Radiographic Evidence of Disease Progression|"Time between date of randomization and earliest date of radiographic progression defined as either:
Tumor progression by RECIST;
Evidence of progression by bone scan;
New skeletal events (New pathologic bone fracture in the region of metastatic disease; New bone lesion requiring radiation or surgery; Spinal cord or nerve root compression).
Participants who were ongoing with no radiographic evidence of disease progression, who discontinued treatment for reasons other than progression,or died before progression were censored at date of last tumor or bone radiographic assessment. Participants who started a new anticancer treatment before progression were censored at date of last tumor or bone radiographic assessment before start of new anti-cancer therapy."|Randomization to date of radiographic progression, up to 36.3 months|"Modified intent to treat population (mITT): All participants who received any quantity of study drug.
34 participants were censored in IMC-A12 arm and 34 participants were censored in IMC-1121B (ramucirumab) arm."||months||95% Confidence Interval|Median
765940|NCT00683475|Secondary|Summary Listing of Participants Reporting Treatment-Emergent Adverse Events|Data presented are the number of participants who experienced A12 or 1121B (ramucirumab) related treatment-emergent adverse events (TEAE), treatment related serious adverse events (SAE), or any Grade 3 or higher TEAE; any TEAE leading to discontinuation of A12 or 1121B (ramucirumab) treatment, and any TEAE leading to dose modification of A12 or 1121B (ramucirumab). A summary of SAEs and other nonserious AEs, regardless of causality, is located in the Reported Adverse Event section.|Randomization to 36.3 months|Modified intent to treat population (mITT): All participants who received any quantity of study drug.||participants|||Number
765949|NCT00683618|Secondary|6 weeksPercentage of Patients Achieved ATP III Guideline (2001) Non High Density Lipoprotein-Cholesterol (nonHDL-C) Goal at Week 6|"The percentage of patients achieved LDL-C goal is done in ITT population.
National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) guideline (2001) LDL-C goal:
Moderately high risk: 2+ risk factors (10-year risk 10%-20%): LDL-C goal < 3.36mmol/L(130mg/dL); non-HDL-C goal < 4.14mmol/L (160mg/dL) ; High risk: Coronary Heart Disease (CHD) or CHD risk equivalents (10-year risk >20%): LDL-C goal< 2.60mmol/L (100mg/dL),non-HDL-C goal < 3.36mmol/L (130mg/dL)"|week 6|Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.||percentage of patients|||Number
766271|NCT00686231|Secondary|To Determine if Topical Nitroglycerin Dilates the Radial Artery in the Presence of Local Anesthetic Agents Used in Cardiac Catheterization.|Radial artery diameter|November 2009||11/2009||||
765941|NCT00683475|Primary|Composite Progression-free Survival (cPFS)|"Defined as the median time from randomization to the earliest of:
Tumor progression by Response Evaluation Criteria in Solid Tumors (RECIST);
Evidence of progression by bone scan, performed after completion of the first 3 cycles, demonstrating the appearance of >=2 new lesions;
New skeletal events (New pathologic bone fracture in the region of metastatic disease; New bone lesion requiring radiation or surgery; Spinal cord or nerve root compression)
Symptomatic progression (for participants without measurable disease);
Other clinical events attributable to prostate cancer that require major interventions; or
Death from any cause
Participants who were ongoing with no progression or who discontinued treatment for reasons other than progression were censored at date of last assessment. Participants who started new anticancer treatment before progression were censored at date of last assessment before start of new anti-cancer therapy."|Randomization to composite progressive disease, up to 23.4 months|"Modified intent to treat population (mITT): All participants who received any quantity of study drug.
11 participants were censored in the IMC-A12 + Mitoxantrone + Prednisone arm. 15 participants were censored in the IMC-1121B (ramucirumab) + Mitoxantrone + Prednisone arm."||months||95% Confidence Interval|Median
765942|NCT00683592|Secondary|MADRS (Montgomery-Asberg Depression Rating Scale) Remission Rate at Week 8|MADRS remission was defined as a MADRS total score < 10 at Week 8. The remission rate is the percentage of subjects in each treatment group who met the criteria for remission. The method of last observation carried forward was utilized for subjects who discontinued prematurely.|Baseline, Week 1, Week 2, Week 4, Week 6, Week 8|Intent-to-Treat (ITT): the ITT population consisted of patients who were randomized, took at least 1 dose of study drug, and had at least 1 post-baseline efficacy endpoint measurement.||Participants|||Number
765943|NCT00683592|Secondary|MADRS (Montgomery-Asberg Depression Rating Scale) Response Rate at Week 8|MADRS response was defined as ≥ 50% decrease from baseline in MADRS total score at Week 8. The response rate is the percentage of subjects in each treatment group meeting the criteria for response. The method of last observation carrier forward was utilized for subjects who discontinued prematurely.|Baseline, Week 1, Week 2, Week 4, Week 6, Week 8|Intent-to-Treat (ITT): the ITT population consisted of patients who were randomized, took at least 1 dose of study drug, and had at least 1 post-baseline efficacy endpoint measurement.||Participants|||Number
765944|NCT00683592|Secondary|Change From Baseline to Week 8 in the HAM-A ( Hamilton Anxiety Rating Scale) Total Score|The HAM-A is a rating scale developed to quantify the severity of anxiety. It consists of 14 items, each defined by a series of symptoms. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe). Change from baseline in the HAM-A total score may range from -52 to 52 with negative value indicating improvement in anxiety symptom severity. The method of last observation carried forward was utilized for subjects who discontinued prematurely.|Baseline, Week 1, Week 2, Week 4, Week 6, Week 8|Intent-to-Treat (ITT): the ITT population consisted of patients who were randomized, took at least 1 dose of study drug, and had at least 1 post-baseline efficacy endpoint measurement.||Units on a scale||95% Confidence Interval|Least Squares Mean
765945|NCT00683592|Secondary|The CGI-I (Clinician's Global Impression of Improvement) Score at Week 8|The CGI-I scale measures change from the baseline state at every visit after the baseline visit. It permits a global evaluation of the patient’s improvement over time. At the scheduled clinic visits, the clinician assessed the patient’s improvement relative to the symptoms at baseline on a CGI-I item using a 7-point scale, where 1 = very much improved and 7 = very much worse. The method of last observation carried forward was utilized for subjects who discontinued prematurely.|Week 1, Week 2, Week 4, Week 6, Week 8|Intent-to-Treat (ITT): the ITT population consisted of patients who were randomized, took at least 1 dose of study drug, and had at least 1 post-baseline efficacy endpoint measurement.||Units on a scale||95% Confidence Interval|Least Squares Mean
765946|NCT00683592|Secondary|Change From Baseline to Week 8 in the HAM-D 17 (17-Item Hamilton Rating Scale for Depression) Total Score|The HAM-D 17 is a 17-item subscale of the HAM-D 21, which is designed to be completed by a trained rater. It is designed for rating depressive symptom severity in patients with a confirmed diagnosis of depressive disorder. The change in HAM-D 17 has a possible range of -52 to 52 with negative values indicating improvment in depression symptom severity. The method of last observation carried forward was utilized for subjects who discontinued prematurely.|Baseline, week 1, week 2, week 4, week 6, week 8|Intent-to-Treat (ITT): the ITT population consisted of patients who were randomized, took at least 1 dose of study drug, and had at least 1 post-baseline efficacy endpoint measurement.||Units on a scale||95% Confidence Interval|Least Squares Mean
765947|NCT00683592|Primary|Change From Baseline to Week 8 in the MADRS (Montgomery-Asberg Depression Rating Scale) Total Score.|The MADRS is an observer rating scale that has proven to be an efficient and practical measure of depression. The scale was constructed to be sensitive to treatment effects. The change from baseline in MADRS total score has a possible range of -60 to 60 where negative values reflect improvement in depression symptom severity. The method of last observation carried forward was utilized for subjects who discontinued prematurely.|Baseline, Week 1, Week 2, Week 4, Week 6, Week 8|Intent-to-Treat (ITT): the ITT population consisted of patients who were randomized, took at least 1 dose of study drug, and had at least 1 post-baseline efficacy endpoint measurement.||Units on a scale||95% Confidence Interval|Least Squares Mean
765948|NCT00683618|Secondary|Percentage of Patients Achieved National Cholesterol Education Program Adult Treatment Panel (NCEP ATP) III Guideline (2001) Low Density Lipoprotein-Cholesterol (LDL-C) Goal After Titration|"The percentage of patients achieved LDL-C goal is done in ITT population.
National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) guideline (2001) LDL-C goal:
Moderately high risk: 2+ risk factors (10-year risk 10%-20%): LDL-C goal < 3.36mmol/L(130mg/dL), non-HDL-C goal < 4.14mmol/L (160mg/dL) ; High risk: Coronary Heart Disease (CHD) or CHD risk equivalents (10-year risk >20%): LDL-C goal< 2.60mmol/L (100mg/dL), non-HDL-C goal < 3.36mmol/L (130mg/dL)"|from week 6 to week 12|Patients did not achieve NCEP ATP III LDL-C goal at the end of 6 weeks randomised treatment period, they entered into extension treatment period upon investigator’s discretion.||percentage of patients|||Number
765962|NCT00683618|Primary|Percentage Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) Concentration After 6 Weeks of Treatment Comparing Rosuvastatin 5mg With Atorvastatin 10mg|Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a two-sided significance level of 0.025 on ITT population.|baseline, 6 weeks|||percent change||Standard Error|Least Squares Mean
765950|NCT00683618|Secondary|Percentage of Patients Achieved ATP III Guideline (2001) Low Density Lipoprotein Cholesterol (LDL-C) Goal at Week 6|"The percentage of patients achieved LDL-C goal is done in ITT population.
National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) guideline (2001) LDL-C goal:
Moderately high risk: 2+ risk factors (10-year risk 10%-20%): LDL-C goal < 3.36mmol/L(130mg/dL), non-HDL-C goal < 4.14mmol/L (160mg/dL) ; High risk: Coronary Heart Disease (CHD) or CHD risk equivalents (10-year risk >20%): LDL-C goal< 2.60mmol/L (100mg/dL), non-HDL-C goal < 3.36mmol/L (130mg/dL)"|week 6|Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.||percentage of patients|||Number
765951|NCT00683618|Secondary|Percentage Change From Baseline in Apolipoprotein B/Apolipoprotein A I (ApoB/ApoA-I) at Week 6|Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.|baseline, 6 weeks|Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.||percent change||Standard Error|Least Squares Mean
765952|NCT00683618|Secondary|Percentage Change From Baseline in Non High Density Lipoprotein Cholesterol/High Density Lipoprotein Cholesterol (nonHDL-C/HDL-C) at Week 6|Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.|baseline, 6 weeks|Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.||percent change||Standard Error|Least Squares Mean
765953|NCT00683618|Secondary|Percentage Change From Baseline in Low Density Lipoprotein Cholesterol/High Density Lipoprotein Cholesterol (LDL-C/HDL-C) at Week 6|Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.|baseline, 6 weeks|Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.||percent change||Standard Error|Least Squares Mean
765954|NCT00683618|Secondary|Percentage Change From Baseline in Total Cholesterol/High Density Lipoprotein-Cholesterol (TC/HDL-C) at Week 6|Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.|baseline, 6 weeks|Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.||percent change||Standard Error|Least Squares Mean
765955|NCT00683618|Secondary|Percentage Change From Baseline in Apolipoprotein A-I (ApoA-I) at Week 6|Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.|baseline, 6 weeks|Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.||percent change||Standard Error|Least Squares Mean
765956|NCT00683618|Secondary|Percentage Change From Baseline in Apolipoprotein B (ApoB) at Week 6|Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.|baseline, 6 weeks|Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.||percent change||Standard Error|Least Squares Mean
765957|NCT00683618|Secondary|Percentage Change From Baseline in Non High Density Lipoprotein-Cholesterol (nonHDL-C) at Week 6|Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.|baseline, 6 weeks|Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.||percent change||Standard Error|Least Squares Mean
765958|NCT00683618|Secondary|Percentage Change From Baseline in Triglycerides (TG) at Week 6|Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.|baseline, 6 weeks|Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.||Percent change||Standard Error|Least Squares Mean
765959|NCT00683618|Secondary|Percentage Change From Baseline in Total Cholesterol (TC ) at Week 6|Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.|baseline, 6 weeks|Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.||percent change||Standard Error|Least Squares Mean
765960|NCT00683618|Secondary|Percentage Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 6|Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.|baseline, 6 weeks|Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.||percent change||Standard Error|Least Squares Mean
765961|NCT00683618|Primary|Percentage Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) Concentration After 6 Weeks of Treatment Comparing Rosuvastatin 10mg With Atorvastatin 10mg|Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.025 on ITT population.|baseline, 6 weeks|||Percent change||Standard Error|Least Squares Mean
765963|NCT00683657|Secondary|Change From Baseline in 2-Day Average Fasting Plasma Glucose (FPG) at Week 4|Adjusted mean change from baseline in 2-day average of FPG at baseline and Week 4. Baseline value=the average of the values at Day -2 and Day 1. Week 4 measurement=average of Day 26 and Day 28 value during the double blind period. At pre-randomization and Day 28 the FPG value was the plasma glucose value collected 30 minutes prior to the morning meal during domicile visits. Mean change from baseline was adjusted for baseline value.|Baseline, Week 4|Randomized participants who took at least 1 dose of double-blind treatment. To be included in an analysis of change from baseline to Week 4 the subject must have had a baseline and a Week 4 measurement.||mg/dL||Standard Error|Mean
765964|NCT00683657|Secondary|Change From Baseline in Mean Daily Glucose at Week 4|Adjusted mean change from baseline in daily glucose at Week 4. Mean daily glucose was calculated based on finger stick glucose measurements collected by the subjects at home in a 3-day period, prior to collection of the 24-hour blood samples at baseline and Week 4. Mean change from baseline was adjusted for baseline value.|Baseline, Week 4|Randomized participants who took at least 1 dose of double-blind treatment. To be included in an analysis of change from baseline to Week 4 the subject must have had a baseline and a Week 4 measurement.||mg/dL||Standard Error|Mean
765965|NCT00683657|Secondary|Change From Baseline in 2-Hour Postprandial Plasma Glucose After the Evening Meal at Week 4|Adjusted mean change from baseline in 2-hour postprandial plasma glucose after the evening meal during 24-hour domicile visits, evaluated both at pre-randomization (baseline) and at Week 4. Mean change from baseline was adjusted for baseline value.|Baseline, Week 4|Randomized participants who took at least 1 dose of double-blind treatment. To be included in an analysis of change from baseline to Week 4 the subject must have had a baseline and a Week 4 measurement.||mg/dL||Standard Error|Mean
765966|NCT00683657|Secondary|Change From Baseline in 4-Hour Mean Weighted Postprandial Plasma Glucose at Week 4|Adjusted mean change from baseline in 4-hour mean weighted postprandial (after mealtime) plasma glucose after the evening meal during 24-hour domicile visits evaluated both at pre-randomization (baseline) and at Week 4. Mean change from baseline was adjusted for baseline value.|Baseline, Week 4|Randomized participants who took at least 1 dose of double-blind treatment. To be included in an analysis of change from baseline to Week 4 the subject must have had a baseline and a Week 4 measurement.||mg/dL||Standard Error|Mean
765967|NCT00683657|Primary|Change From Baseline in 24-Hour Mean Weighted Glucose (MWG) at Week 4|Adjusted mean change from baseline in MWG achieved with saxagliptin 5 mg plus metformin XR versus placebo plus metformin XR at Week 24. MWG was calculated as the area under the curve (AUC) for the full 24 hours expressed as average mg/dL. Glucose measurements were collected 30 minutes before and just prior to each meal (0 minutes) and 30, 60, 120, and 180 minutes after each meal (with 1 additional measurement at 240 minutes after the evening meal), midnight, 3 AM, and at end-of-domicile visit 24 hours after the first measurement. Mean change from baseline was adjusted for baseline value.|Baseline, Week 4|Randomized participants who took at least 1 dose of double-blind treatment. To be included in an analysis of change from baseline to Week 4 the subject must have had a baseline and a Week 4 measurement.||mg/dL||Standard Error|Mean
765968|NCT00683696|Secondary|Number of Subjects With All-cause Mortality|Evaluate the all-cause mortality rate between the CRT=ON compared to CRT=OFF group.|Study duration from randomization to study exit||||||
765969|NCT00683696|Secondary|Composite Score of Death, Hospitalization for Worsening Heart Failure and Change in Quality of Life|Evaluate the effects of CRT=ON compared to CRT=OFF in relation to a composite endpoint of all-cause mortality, hospitalization for worsening heart failure and change in the MLHF Quality of Life Questionnaire.|Study duration from randomization to study exit for death, 24 months for hospitalization, 6 months for QOL evaluation||||||
765970|NCT00683696|Secondary|Change in Quality of Life Scores From Baseline to 6-Month Follow-up|Evaluate the effects of CRT=ON compared to CRT=OFF in relation to the change in the Minnesota Living with Heart Failure (MLHF) Quality of Life (QOL) Questionnaire.|6 months||||||
765971|NCT00683696|Secondary|NYHA Classification Change|Evaluate the effects of CRT=ON compared to CRT=OFF in relation to the change in NYHA classification.|6 months||||||
765972|NCT00683696|Secondary|Rate of Worsening Heart Failure Hospitalization (Hospitalizations Per Subject-year)|Evaluate the effects of CRT=ON compared to CRT=OFF on the rate of hospitalization for worsening heart failure (WHF).|Study duration from randomization to study exit||||||
765973|NCT00683696|Primary|Number of Subjects That Underwent Implant Attempt Without System- or Implant-Related Complications (Complication-Free)|The primary safety endpoint will evaluate the complication-free rate of the Lumax HF-T CRT-D devices in the narrow QRS subject population.|6 months|The primary safety endpoint included all subjects undergoing an implant procedure.||participants|||Number
765974|NCT00683696|Primary|Composite Primary Endpoint: Number of Subjects With First Hospitalization for Worsening Heart Failure or Death|The primary efficacy endpoint will evaluate the effect of CRT=ON versus CRT=OFF in time to event of a combined endpoint of all-cause mortality or first hospitalization for worsening heart failure.|From date of randomization until date of death from any cause or date of first hospitalization for worsening heart failure, whichever came first, assessed up to date of study exit, with a mean treatment duration of 1.6 years|This analysis was carried out according to the intention-to-treat principle. Follow-up was censored at study closure, date of death, LVAD, heart transplant, withdrawal from the study, or loss to follow-up, whichever came first. 4 deaths in CRT OFF group and 1 death in CRT ON group were after LVAD/transplant and are not included in this analysis.||participants|||Number
765975|NCT00683774|Primary|Level of Circulating D-chiro Inositol (DCI)|Measured circulating concentration of plasma DCI following inhibition of insulin release using diazoxide|12 days|||nmol/mL||Full Range|Mean
765976|NCT00683774|Primary|Renal Clearance of D-chiroinositol (DCI) at 12 Days|Following inhibition of insulin release using diazoxide, measured renal clearance of D-chiro inositol (DCI) via urinary Chiro-inositol dci assay|12 days|||ml/min||Full Range|Mean
765977|NCT00683787|Secondary|Toxicity||1 year|Due to the study's early termination and inadequate number of patients no statistical inference of the primary and secondary aims were carried forth.|||||
765978|NCT00683787|Secondary|Overall Survival||3 years|Due to the study's early termination and inadequate number of patients no statistical inference of the primary and secondary aims were carried forth.|||||
765979|NCT00683787|Secondary|Progression-free Survival||3 years|Due to the study's early termination and inadequate number of patients no statistical inference of the primary and secondary aims were carried forth.|||||
765981|NCT00676520|Secondary|SAQ (Seattle Angina Questionaire)|"SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease:
Anginal Stability: whether a patient's symptoms are changing over time. Anginal Frequency: how often a patient is having symptoms now Physical Limitation: how much a patient's condition is hampering his ability to do what he wants to do.
Treatment Satisfaction: how well a patient understands her care and what she thinks of it.
Disease Perception: the overall impact of a patient's condition on a patient's interpersonal relationships and state of mind.
Each dimension is assigns each response an ordinal value, beginning with 1 for the response at the lowest level of functioning, and summing across items within each of the 5 scales. Scale scores then transformed to 0-100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100."|1 year|"First enrollment phase of ~5,000 patients only. Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure.
The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."||units on the SAQ scale||Standard Deviation|Mean
765982|NCT00676520|Secondary|SAQ (Seattle Angina Questionaire)|"SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease:
Anginal Stability: whether a patient's symptoms are changing over time. Anginal Frequency: how often a patient is having symptoms now Physical Limitation: how much a patient's condition is hampering his ability to do what he wants to do.
Treatment Satisfaction: how well a patient understands her care and what she thinks of it.
Disease Perception: the overall impact of a patient's condition on a patient's interpersonal relationships and state of mind.
Each dimension is assigns each response an ordinal value, beginning with 1 for the response at the lowest level of functioning, and summing across items within each of the 5 scales. Scale scores then transformed to 0-100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100."|180 days|"First enrollment phase of ~5,000 patients only. Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure.
The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."||units on the SAQ scale||Standard Deviation|Mean
765983|NCT00676520|Secondary|SAQ (Seattle Angina Questionaire)|"SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease:
Anginal Stability: whether a patient’s symptoms are changing over time. Anginal Frequency: how often a patient is having symptoms now Physical Limitation: how much a patient’s condition is hampering his ability to do what he wants to do.
Treatment Satisfaction: how well a patient understands her care and what she thinks of it.
Disease Perception: the overall impact of a patient’s condition on a patient’s interpersonal relationships and state of mind.
Each dimension is assigns each response an ordinal value, beginning with 1 for the response at the lowest level of functioning, and summing across items within each of the 5 scales. Scale scores then transformed to 0-100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100."|at baseline|"First enrollment phase of ~5,000 patients only. Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure.
The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."||units on the SAQ scale||Standard Deviation|Mean
765984|NCT00676520|Secondary|Patient Health Status, Physical Limitations Assessed Using the SAQ (Seattle Angina Questionaire)|"SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease:
Anginal Stability: whether a patient’s symptoms are changing over time. Anginal Frequency: how often a patient is having symptoms now Physical Limitation: how much a patient’s condition is hampering his ability to do what he wants to do.
Treatment Satisfaction: how well a patient understands her care and what she thinks of it.
Disease Perception: the overall impact of a patient’s condition on a patient’s interpersonal relationships and state of mind.
Each dimension is assigns each response an ordinal value, beginning with 1 for the response at the lowest level of functioning, and summing across items within each of the 5 scales. Scale scores then transformed to 0-100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100."|at 1 year|"First enrollment phase of ~5,000 patients only. Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure.
The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."||units on the SAQ scale||Standard Deviation|Mean
765985|NCT00676520|Secondary|Patient Health Status, Physical Limitations Assessed Using the SAQ (Seattle Angina Questionaire)|"SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease:
Anginal Stability: whether a patient’s symptoms are changing over time. Anginal Frequency: how often a patient is having symptoms now Physical Limitation: how much a patient’s condition is hampering his ability to do what he wants to do.
Treatment Satisfaction: how well a patient understands her care and what she thinks of it.
Disease Perception: the overall impact of a patient’s condition on a patient’s interpersonal relationships and state of mind.
Each dimension is assigns each response an ordinal value, beginning with 1 for the response at the lowest level of functioning, and summing across items within each of the 5 scales. Scale scores then transformed to 0-100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100."|at 180 days|"First enrollment phase of ~5,000 patients only. Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure.
The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."||units on the SAQ scale||Standard Deviation|Mean
765995|NCT00676520|Secondary|Major Bleeding Complications|by TIMI flow|at 1 year|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.
The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."||percentage of participants||95% Confidence Interval|Number
765996|NCT00676520|Secondary|Major Bleeding Complications|by TIMI flow|at 180 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.
The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."||percentage of participants||95% Confidence Interval|Number
766272|NCT00686231|Primary|To Determine if Topical Nitroglycerin Acts to Vasodilate the Radial Artery.|Diameter of radial artery|November 2009|||mm||Standard Deviation|Mean
765986|NCT00676520|Secondary|Patient Health Status, Physical Limitations Assessed Using the SAQ (Seattle Angina Questionaire)|"SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease:
Anginal Stability: whether a patient’s symptoms are changing over time. Anginal Frequency: how often a patient is having symptoms now Physical Limitation: how much a patient’s condition is hampering his ability to do what he wants to do.
Treatment Satisfaction: how well a patient understands her care and what she thinks of it.
Disease Perception: the overall impact of a patient’s condition on a patient’s interpersonal relationships and state of mind.
Each dimension is assigns each response an ordinal value, beginning with 1 for the response at the lowest level of functioning, and summing across items within each of the 5 scales. Scale scores then transformed to 0-100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100."|at baseline|"First enrollment phase of ~5,000 patients only. Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure.
The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."||units on the SAQ scale||Standard Deviation|Mean
765987|NCT00676520|Secondary|Composite Rate of Cardiac Death and MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Clinically-indicated Target Lesion Revascularization (CI-TLR) (PCI and CABG) (This Composite Endpoint is Also Denoted as TLF)|MI= Academic Research Consortium (ARC) defined|at 1 year|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.
The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."||percentage of participants||95% Confidence Interval|Number
765988|NCT00676520|Secondary|Composite Rate of Cardiac Death and MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Clinically-indicated Target Lesion Revascularization (CI-TLR) (PCI and CABG) (This Composite Endpoint is Also Denoted as TLF)|MI= Academic Research Consortium (ARC) defined|at 180 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.
The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."||percentage of participants||95% Confidence Interval|Number
765989|NCT00676520|Secondary|Composite Rate of Cardiac Death and MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Clinically-indicated Target Lesion Revascularization (CI-TLR) (PCI and CABG) (This Composite Endpoint is Also Denoted as TLF)|MI= Academic Research Consortium (ARC) defined|at 30 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.
The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."||percentage of participants||95% Confidence Interval|Number
765990|NCT00676520|Secondary|Dual Antiplatelet Therapy Non-compliance Through 1 Year|Defined as patients who had at least 1 day without using either aspirin or thienopyridine from 1 to 407 days post index procedure.|1 year|Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.||percentage of participants|||Number
765991|NCT00676520|Secondary|Dual Antiplatelet Medication Usage|"Patient is included if medications (both aspirin and thienopyridine) were taken for at least 1 day during the visit window. The visit window for 14-day visit is 7-21 days, 30-day visit is 23-37 days, 180-day visit is 166-194 days, 1-year visit is 323-407 days, and 2-year visit is 688-772 days.
Adjunctive antiplatelet therapy includes: Aspirin & Thienopyridines (Clopidogrel/Ticlopidine/Prasugrel).
Compliance refers to subjects following prescribed instructions for taking these medications. Therapy interruptions refer to any intervals during which the subject stops taking one or all of the prescribed medications."|at 1 year|Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.||percentage of participants|||Number
765992|NCT00676520|Secondary|Dual Antiplatelet Medication Usage|"Patient is included if medications (both aspirin and thienopyridine) were taken for at least 1 day during the visit window. The visit window for 14-day visit is 7-21 days, 30-day visit is 23-37 days, 180-day visit is 166-194 days, 1-year visit is 323-407 days, and 2-year visit is 688-772 days.
Adjunctive antiplatelet therapy includes: Aspirin & Thienopyridines (Clopidogrel/Ticlopidine/Prasugrel).
Compliance refers to subjects following prescribed instructions for taking these medications. Therapy interruptions refer to any intervals during which the subject stops taking one or all of the prescribed medications."|at 180 days|Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.||percentage of participants|||Number
765993|NCT00676520|Secondary|Dual Antiplatelet Medication Usage|"Patient is included if medications (both aspirin and thienopyridine) were taken for at least 1 day during the visit window. The visit window for 14-day visit is 7-21 days, 30-day visit is 23-37 days, 180-day visit is 166-194 days, 1-year visit is 323-407 days, and 2-year visit is 688-772 days.
Adjunctive antiplatelet therapy includes: Aspirin & Thienopyridines (Clopidogrel/Ticlopidine/Prasugrel).
Compliance refers to subjects following prescribed instructions for taking these medications. Therapy interruptions refer to any intervals during which the subject stops taking one or all of the prescribed medications."|at 30 days|Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.||percentage of participants|||Number
765994|NCT00676520|Secondary|Dual Antiplatelet Medication Usage|"Patient is included if medications (both aspirin and thienopyridine) were taken for at least 1 day during the visit window. The visit window for 14-day visit is 7-21 days, 30-day visit is 23-37 days, 180-day visit is 166-194 days, 1-year visit is 323-407 days, and 2-year visit is 688-772 days.
Adjunctive antiplatelet therapy includes: Aspirin & Thienopyridines (Clopidogrel/Ticlopidine/Prasugrel).
Compliance refers to subjects following prescribed instructions for taking these medications. Therapy interruptions refer to any intervals during which the subject stops taking one or all of the prescribed medications."|at 14 days|Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.||percentage of participants|||Number
766024|NCT00676585|Secondary|Mortality||Length of hospital stay, an average of 9 days with a maximum of 36 days|||Participants|||Count of Participants
765997|NCT00676520|Secondary|Major Bleeding Complications|by TIMI flow|at 30 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.
The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."||percentage of participants||95% Confidence Interval|Number
765998|NCT00676520|Secondary|Major Bleeding Complications|by TIMI flow|at 14 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.
The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."||percentage of participants||95% Confidence Interval|Number
765999|NCT00676520|Secondary|Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG)||at 1 year|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.
The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."||percentage of participants||95% Confidence Interval|Number
766000|NCT00676520|Secondary|Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG)||at 180 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.
The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."||percentage of participants||95% Confidence Interval|Number
766001|NCT00676520|Secondary|Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG)||at 30 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.
The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."||percentage of participants||95% Confidence Interval|Number
766002|NCT00676520|Secondary|Any MI (Q-wave and Non Q-wave)|MI= Academic Research Consortium (ARC) defined|at 1 year|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.
The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."||percentage of participants||95% Confidence Interval|Number
766003|NCT00676520|Secondary|Any MI (Q-wave and Non Q-wave)|MI= Academic Research Consortium (ARC) defined|at 180 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.
The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."||percentage of participants||95% Confidence Interval|Number
766004|NCT00676520|Secondary|Any MI (Q-wave and Non Q-wave)|MI= Academic Research Consortium (ARC) defined|at 30 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.
The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."||percentage of participants||95% Confidence Interval|Number
766005|NCT00676520|Secondary|Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death)||at 1 year|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.
The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."||percentage of participants||95% Confidence Interval|Number
766006|NCT00676520|Secondary|Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death)||at 180 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.
The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."||percentage of participants||95% Confidence Interval|Number
766007|NCT00676520|Secondary|Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death)||at 30 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.
The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."||percentage of participants||95% Confidence Interval|Number
766008|NCT00676520|Secondary|Composite Rate of Cardiac Death, Any MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Target Lesion Revascularization (TLR) (PCI and CABG)|MI= Academic Research Consortium (ARC) defined|at 1 year|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.
The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."||percentage of participants||95% Confidence Interval|Number
766009|NCT00676520|Secondary|Composite Rate of Cardiac Death, Any MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Target Lesion Revascularization (TLR) (PCI and CABG)|MI= Academic Research Consortium (ARC) defined|at 180 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.
The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."||percentage of participants||95% Confidence Interval|Number
766010|NCT00676520|Secondary|Composite Rate of Cardiac Death, Any MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Target Lesion Revascularization (TLR) (PCI and CABG)|MI= Academic Research Consortium (ARC) defined|at 30 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.
The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."||percentage of participants||95% Confidence Interval|Number
766025|NCT00676585|Primary|Time to Shock Reversal|The primary outcome was time to shock reversal defined as at least 24 hours off all vasopressor medications.|7 Days|||hours||Inter-Quartile Range|Median
766273|NCT00686257|Secondary|In-hospital Mortality Rate||during hospitalization (after recruitment)||||||
766011|NCT00676520|Secondary|Composite Rate of All Death, Any MI (Q-wave and Non Q-wave) and Any Repeat Revascularization (Percutaneous Coronary Intervention [PCI] and Coronary Artery Bypass Graft [CABG])|MI= Academic Research Consortium (ARC) defined|at 1 year|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.
The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."||percentage of participants||95% Confidence Interval|Number
766012|NCT00676520|Secondary|Composite Rate of All Death, Any MI (Q-wave and Non Q-wave) and Any Repeat Revascularization (Percutaneous Coronary Intervention [PCI] and Coronary Artery Bypass Graft [CABG])|MI= Academic Research Consortium (ARC) defined|at 180 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.
The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."||percentage of participants||95% Confidence Interval|Number
766013|NCT00676520|Secondary|Composite Rate of All Death, Any MI (Q-wave and Non Q-wave) and Any Repeat Revascularization (Percutaneous Coronary Intervention [PCI] and Coronary Artery Bypass Graft [CABG])|MI= Academic Research Consortium (ARC) defined|at 30 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.
The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."||percentage of participants||95% Confidence Interval|Number
766014|NCT00676520|Secondary|Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)|MI= Academic Research Consortium (ARC) defined|at 1 year|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.
The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."||percentage of participants||95% Confidence Interval|Number
766015|NCT00676520|Secondary|Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)|MI= Academic Research Consortium (ARC) defined|at 180 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.
The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."||percentage of participants||95% Confidence Interval|Number
766016|NCT00676520|Secondary|Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)|MI= Academic Research Consortium (ARC) defined|at 30 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.
The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."||percentage of participants||95% Confidence Interval|Number
766017|NCT00676520|Secondary|Composite Rate of Cardiac Death and Any MI (Q-wave and Non Q-wave)|MI= Academic Research Consortium (ARC) defined|at 180 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.
The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."||percentage of participants||95% Confidence Interval|Number
766018|NCT00676520|Secondary|Composite Rate of Cardiac Death and Any MI (Q-wave and Non Q-wave)|MI= Academic Research Consortium (ARC) defined|at 30 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.
The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."||percentage of participants||95% Confidence Interval|Number
766019|NCT00676520|Secondary|Procedural Success||acute: post index procedure until hospital discharge|Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.||percentage of participants||95% Confidence Interval|Number
766020|NCT00676520|Secondary|Clinical Device Success||acute: post index procedure until hospital discharge|Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.||percentage of lesions|Participants|95% Confidence Interval|Number
766021|NCT00676520|Primary|Composite Rate of Cardiac Death and Any Myocardial Infarction (MI)|MI= ARC (Academic Research Constortium) defined|1 year|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.
The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."||percentage of participants||95% Confidence Interval|Number
766022|NCT00676520|Primary|Stent Thrombosis (Definite and Probable) Rate as Defined by ARC (Academic Research Constortium).|"ARC Defines Stent Thrombosis in the following way:
Definite Stent Thrombosis: Angiographic or pathologic confirmation of partial or total thrombotic occlusion within the peri-stent region AND at least ONE of the following, additional criteria:
Acute ischemic symptoms Ischemic ECG changes Elevated cardiac biomarkers
Probable Stent Thrombosis: Any unexplained death within 30 days of stent implantation or any myocardial infarction, which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause
Possible Stent Thrombosis Any unexplained death beyond 30 days
For further information on ARC definitions, please refer to the following website: http://circ.ahajournals.org/content/115/17/2344.full#sec-1"|up to 1 year|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.
The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."||percentage of participants||95% Confidence Interval|Number
766023|NCT00676585|Secondary|Sub-group Analysis of Patients With Adrenal Insufficiency|Sub-analysis of patients with adrenal insufficiency: absolute insufficiency as defined by a baseline cortisol level < 15 ug/dL|At time of enrollment|There were 9 patients identified with baseline absolute cortisol deficiency (3 in the control arm and 6 in the intervention arm). This sub population of study participants were analyzed for shock reversal, good neurological outcomes, and survival as shown in each row of the table below.||Participants|||Count of Participants
766026|NCT00676650|Secondary|Change From Baseline in Euro Quality of Life (EQ-5D)- Health State Profile Utility Score|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Overall scores range from 0 to 1, with lower scores representing a higher level of dysfunction."|Baseline, every 4 weeks up to 123 weeks|Data not summarized, study terminated early|||||
766027|NCT00676650|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P)|FACT-P is a validated, self-administered instrument used to assess health-related quality of life and prostate cancer-specific symptoms. Scores ranged from 0 (not at all) to 4 (very much). It is 27-item FACT-General and 12 items for the prostate cancer specific concerns. The 27 items in FACT-G are grouped into 4 domains: physical well-being, social/family well-being, emotional well-being and functional well-being. The 12 prostate cancer symptoms items focus on pain (3 items), urination problems (3 items), sexual functions (2 items), weight loss, appetite, overall comfort, and bowel movement.|Baseline, every 4 weeks up to 123 weeks|Data not summarized, study terminated early|||||
766028|NCT00676650|Secondary|Change From Baseline in Pain Severity|Pain severity recorded on a numerical scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). Higher scores indicated greater level of pain. The pain score for each cycle averaged for the 7 days.|Day 1 through Day 7 every 28 days (every cycle) up to 29 months|Data not summarized, study terminated early|||||
766029|NCT00676650|Secondary|Duration of Response (DR)|Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cause - the date of the first CR or PR that was subsequently confirmed plus 1 divided by 7.02. DR calculated for the subgroup of participants with a confirmed objective tumor response|Baseline, every 8 weeks up to 123 weeks|Data not summarized, study terminated early|||||
766030|NCT00676650|Secondary|Percent of Participants With Objective Response (OR)|OR defined as the percent (%) of participants with confirmed Complete Response (CR) (disappearance of all target lesions) or Partial Response (PR) (>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions) according to Response Evaluation Criteria in Solid Tumors (RECIST), relative to the full analysis population. Confirmed responses were those that persist on repeat imagining study >= 4 weeks after initial documentation of response.|Baseline, every 8 weeks up to 123 weeks|FA Population||percentage of participants||95% Confidence Interval|Number
766031|NCT00676650|Secondary|Progression-Free Survival (PFS)|PFS is the period from randomization until disease progression or death on study. PFS is censored on the date of last tumor assessment documenting absence of progressive disease. PFS (weeks) calculated as (first event date - randomization date + 1)/7.02|Baseline, every 8 weeks up to 123 weeks|FA Population||weeks||95% Confidence Interval|Median
766032|NCT00676650|Primary|Overall Survival (OS)|OS is the duration from randomization to death. For participants who were alive, overall survival was censored at the last contact. OS (in months) calculated as (date of death minus [-] date of randomization plus [+] 1) divided (/) 30.4.|Baseline up to 32 months|Full analysis (FA) population: all participants who were randomized, with study drug assignment designated according to initial randomization, regaradless of whether participant received study drug according to the randomization schedule.||months||95% Confidence Interval|Median
766033|NCT00676676|Primary|Montgomery-Asberg Depression Rating Scale (MADRS) Scale|the MADRS is a diagnostic questionnaire that is used to measure the severity of depressive episodes in patients with mood disorders. The minimum and maximum values are 0 and 60 respectively (higher scores are more severe).|Baseline, 2-week, 8-week|This was a pilot protocol||units on a scale||Standard Deviation|Mean
766034|NCT00676689|Secondary|Functional Improvement|"Functional improvement at 6 months as defined by:
a) Improved valve hemodynamics as demonstrated via Transthoracic Echo: i) Decrease in pulmonary regurgitation to mild or less for regurgitant lesions ii) Decrease in mean pulmonary gradient to less than 30 mmHg for stenotic lesions iii) Improvement in both i) and ii) above for mixed lesions b) Improvement of ≥ 1 NYHA functional class from baseline for patients with NYHA functional class ≥ 2 at baseline c) Freedom from recurrent pulmonary stenosis."|6 months|Valve implant population. There were 2 screen failure patients and 10 patients where procedure was started but the study valve not implanted, leaving 69 patients in the Valve Implant Population. There were 11 additional patients for which data was not available for analysis, leaving 58 patients in this analysis.||participants|||Number
766035|NCT00676689|Secondary|Freedom From MACCE|Clinical Events Committee (CEC) adjudicated.|6 Months|Valve implant population. There were 2 screen failure patients and 10 patients where the procedure was started but the study valve not implanted, leaving 69 patients in the Valve Implant Population.||percentage of participants||95% Confidence Interval|Number
766036|NCT00676689|Primary|Freedom From Device or Procedure Related Death or Reintervention||1 year|Valve implant population. There were 2 screen failure patients and 10 patients where the procedure was started but the study valve not implanted, leaving 69 patients in the Valve Implant Population.||percentage of participants||95% Confidence Interval|Number
766274|NCT00686257|Secondary|Length of Hospital Stay||during hospitalization (after recruitment)||||||
766043|NCT00676780|Primary|Change in Serum Hepatocyte Growth Factor (HGF) and Prostate Cancer.|Change in serum hepatocyte growth factor (HGF) from baseline to post Polyphenol E treatment.|Baseline and 6 weeks|Number of participants for analysis was determined per protocol.||pg/mL||Inter-Quartile Range|Median
766044|NCT00676780|Primary|Change in Serum Vascular Endothelial Growth Factor (VEGF) and Prostate Cancer.|Change in serum vascular endothelial growth factor (VEGF) from baseline to post Polyphenol E treatment.|Baseline and 6 weeks.|The number of participants for analysis was determined per protocol.||pg/mL||Inter-Quartile Range|Median
766045|NCT00676780|Primary|Change in Serum Prostate Specific Antigen (PSA) of Prostate Cancer|Change in serum prostate specific antigen (PSA) from baseline to post Polyphenol E treatment.|Baseline and 6 weeks|The number of participants for analysis was determined per protocol.||ng/mL||Inter-Quartile Range|Median
766046|NCT00683800|Other Pre-specified|Number of Participants With Hepatic Events|Hepatic events were defined as incidence of increased Liver Function Test (AST [aspartate aminotransferase] or ALT [alanine aminotransferase]) levels greater than 5 times the ULN (upper limit of normal).|Baseline up to Month 12|Safety population included all randomized participants who received at least 1 dose of study medication.||Participants|||Number
766047|NCT00683800|Other Pre-specified|Number of Participants With Ischemic Heart Disease|"Potential ischaemic cardiac events were identified using the Standardized MedDRA Query (SMQ) Ischemic Heart Disease."|Baseline up to Month 12|Safety population included all randomized participants who received at least 1 dose of study medication.||Participants|||Number
766048|NCT00683800|Other Pre-specified|Number of Participants With Adjudicated Cerebrovascular Events - Probable TIA|Adjudicated cerebrovascular events were identified using Standardized MedDRA Query (SMQ), for “central nervous system haemorrhages and cerebrovascular conditions”. Primary assessments included: 1) definite stroke, 2) probable stroke, 3) probable transient ischemic attack (TIA), and 4) no stroke or TIA.|Baseline up to Month 12|Safety population included all randomized participants who received at least 1 dose of study medication.||Participants|||Number
766049|NCT00683800|Other Pre-specified|Number of Participants With Adjudicated Cerebrovascular Events - Any Stroke|Adjudicated cerebrovascular events were identified using Standardized MedDRA Query (SMQ), for “central nervous system haemorrhages and cerebrovascular conditions”. Primary assessments included: 1) definite stroke, 2) probable stroke, 3) probable transient ischemic attack (TIA), and 4) no stroke or TIA.|Baseline up to Month 12|Safety population included all randomized participants who received at least 1 dose of study medication.||Participants|||Number
766050|NCT00683800|Secondary|Percentage of Participants With Categorical Scores Based on Patient Global Impression Change (PGI-C) for MITT Population of Efficacy Substudy at Month 12|PGI-C score was intended to assess the study participant’s perception of changes in hot flushes. It was 7-point scale which ranged from 1 (Very Much Improved) to 7 (Very Much Worse).|Month 12|MITT population: All participants randomized into efficacy substudy; at least 1 dose of study drug, vasomotor symptoms recorded on at least 1 day of baseline period and 1 day of on-therapy period during initial 12 weeks of therapy. LOCF method was used. Participants analyzed included those who were evaluated for this particular scale.||Percentage of Participants|||Number
766051|NCT00683800|Secondary|Percentage of Participants With Categorical Scores on Patient Global Impression Change (PGI-C) for MITT Population of Efficacy Substudy at Month 6|PGI-C score was intended to assess the study participant’s perception of changes in hot flushes. It was 7-point scale which ranged from 1 (Very Much Improved) to 7 (Very Much Worse).|Month 6|MITT population: All participants randomized into efficacy substudy; at least 1 dose of study drug, vasomotor symptoms recorded on at least 1 day of baseline period and 1 day of on-therapy period during initial 12 weeks of therapy. LOCF method was used. Participants analyzed included those who were evaluated for this particular scale.||Percentage of Participants|||Number
766052|NCT00683800|Secondary|Percentage of Participants With Categorical Scores on Patient Global Impression Change (PGI-C) for MITT Population of Efficacy Substudy at Week 12|PGI-C score was intended to assess the study participant’s perception of changes in hot flushes. It was 7-point scale which ranged from 1 (Very Much Improved) to 7 (Very Much Worse).|Week 12|MITT population: All participants randomized into efficacy substudy; at least 1 dose of study drug, vasomotor symptoms recorded on at least 1 day of baseline period and 1 day of on-therapy period during initial 12 weeks of therapy. LOCF method was used. Participants analyzed included those who were evaluated for this particular scale.||Percentage of Participants|||Number
766053|NCT00683800|Secondary|Percentage of Participants With Categorical Scores Based on Patient Global Impression Change (PGI-C) for Main Study Efficacy Population at Month 12|PGI-C score was intended to assess the study participant’s perception of changes in hot flushes. It was 7-point scale which ranged from 1 (Very Much Improved) to 7 (Very Much Worse).|Month 12|Main study efficacy population included all participants who were randomized; had at least 1 dose of study medication; and had a baseline and at least 1 on therapy GCS assessment or at least 1 on therapy PGI assessment. Assessment was done using LOCF method.||Percentage of Participants|||Number
766054|NCT00683800|Secondary|Percentage of Participants With Categorical Scores on Patient Global Impression Change (PGI-C) for Main Study Efficacy Population at Month 6|PGI-C score was intended to assess the study participant’s perception of changes in hot flushes. It was 7-point scale which ranged from 1 (Very Much Improved) to 7 (Very Much Worse).|Month 6|Main study efficacy population included all participants who were randomized; had at least 1 dose of study medication; and had a baseline and at least 1 on therapy GCS assessment or at least 1 on therapy PGI assessment. Assessment was done using LOCF method.||Percentage of Participants|||Number
766055|NCT00683800|Secondary|Percentage of Participants With Categorical Scores on Patient Global Impression Change (PGI-C) for Main Study Efficacy Population at Week 12|PGI-C score was intended to assess the study participant’s perception of changes in hot flushes. It was 7-point scale which ranged from 1 (Very Much Improved) to 7 (Very Much Worse).|Week 12|Main study efficacy population included all participants who were randomized; had at least 1 dose of study medication; and had a baseline and at least 1 on therapy GCS assessment or at least 1 on therapy PGI assessment. Assessment was done using LOCF method.||Percentage of Participants|||Number
766056|NCT00683800|Secondary|Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for MITT Population of Efficacy Substudy at Month 12|PGI-R scale was intended to assess the study participant's perception of symptoms. Participants were requested to identify the severity of their hot flush symptoms. It was a 5-scale which ranged from 1 (None) to 5 (Severe).|Month 12|MITT population: All participants randomized into efficacy substudy; at least 1 dose of study drug, vasomotor symptoms recorded on at least 1 day of baseline period and 1 day of on-therapy period during initial 12 weeks of therapy. LOCF method was used. Participants analyzed included those who were evaluated for this particular scale.||Percentage of Participants|||Number
766057|NCT00683800|Secondary|Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for MITT Population of Efficacy Substudy at Month 6|PGI-R scale was intended to assess the study participant's perception of symptoms. Participants were requested to identify the severity of their hot flush symptoms. It was a 5-scale which ranged from 1 (None) to 5 (Severe).|Month 6|MITT population: All participants randomized into efficacy substudy; at least 1 dose of study drug, vasomotor symptoms recorded on at least 1 day of baseline period and 1 day of on-therapy period during initial 12 weeks of therapy. LOCF method was used. Participants analyzed included those who were evaluated for this particular scale.||Percentage of Participants|||Number
766058|NCT00683800|Secondary|Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for MITT Population of Efficacy Substudy at Week 12|PGI-R scale was intended to assess the study participant's perception of symptoms. Participants were requested to identify the severity of their hot flush symptoms. It was a 5-scale which ranged from 1 (None) to 5 (Severe).|Week 12|MITT population: All participants randomized into efficacy substudy; at least 1 dose of study drug, vasomotor symptoms recorded on at least 1 day of baseline period and 1 day of on-therapy period during initial 12 weeks of therapy. LOCF method was used. Participants analyzed included those who were evaluated for this particular scale.||Percentage of Participants|||Number
766059|NCT00683800|Secondary|Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for Main Study Efficacy Population at Month 12|PGI-R scale was intended to assess the study participant's perception of symptoms. Participants were requested to identify the severity of their hot flush symptoms. It was a 5-scale which ranged from 1 (None) to 5 (Severe).|Month 12|Main study efficacy population included all participants who were randomized; had at least 1 dose of study medication; and had a baseline and at least 1 on therapy GCS assessment or at least 1 on therapy PGI assessment. Assessment was done using LOCF method.||Percentage of Participants|||Number
766060|NCT00683800|Secondary|Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for Main Study Efficacy Population at Month 6|PGI-R scale was intended to assess the study participant's perception of symptoms. Participants were requested to identify the severity of their hot flush symptoms. It was a 5-scale which ranged from 1 (None) to 5 (Severe).|Month 6|Main study efficacy population included all participants who were randomized; had at least 1 dose of study medication; and had a baseline and at least 1 on therapy GCS assessment or at least 1 on therapy PGI assessment. Assessment was done using LOCF method.||Percentage of Participants|||Number
766061|NCT00683800|Secondary|Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for Main Study Efficacy Population at Week 12|PGI-R scale was intended to assess the study participant's perception of symptoms. Participants were requested to identify the severity of their hot flush symptoms. It was a 5-scale which ranged from 1 (None) to 5 (Severe).|Week 12|Main study efficacy population included all participants who were randomized; had at least 1 dose of study medication; and had a baseline and at least 1 on therapy GCS assessment or at least 1 on therapy PGI assessment. Assessment was done using LOCF method.||Percentage of Participants|||Number
766062|NCT00683800|Secondary|Change From Baseline in the Total Greene Climacteric Scale (GCS) Score and GCS Subscores at Month 12|GCS: a 21 item evaluation of symptoms which asked participants how bothered they were with particular symptom at the moment. Each item was scored as 0 = Not at all, 1 = A little, 2 = Quite a bit, and 3 = Extremely. A total score was derived from the sum of the 21 items (range 0-63). GCS was also used to generate 6 individual scores (psychological symptoms [range 0-33], anxiety [range 0-18], depression [range 0-15], somatic symptoms [range 0-21], vasomotor symptoms [range 0-6], and sexual dysfunction [range 0-3]). A decrease in the total climacteric score indicated an improvement in symptoms.|Baseline and Month 12|Main study efficacy population included all participants who were randomized; had at least 1 dose of study medication; and had a baseline and at least 1 on therapy GCS assessment or at least 1 on therapy PGI assessment.||Units on a Scale||Standard Error|Mean
766063|NCT00683800|Secondary|Change From Baseline in the Total Greene Climacteric Scale (GCS) Score and GCS Subscores at Month 6|GCS: a 21 item evaluation of symptoms which asked participants how bothered they were with particular symptom at the moment. Each item was scored as 0 = Not at all, 1 = A little, 2 = Quite a bit, and 3 = Extremely. A total score was derived from the sum of the 21 items (range 0-63). GCS was also used to generate 6 individual scores (psychological symptoms [range 0-33], anxiety [range 0-18], depression [range 0-15], somatic symptoms [range 0-21], vasomotor symptoms [range 0-6], and sexual dysfunction [range 0-3]). A decrease in the total climacteric score indicated an improvement in symptoms.|Baseline and Month 6|Main study efficacy population included all participants who were randomized; had at least 1 dose of study medication; and had a baseline and at least 1 on therapy GCS assessment or at least 1 on therapy PGI assessment.||Units on a Scale||Standard Error|Mean
766064|NCT00683800|Secondary|Change From Baseline in the Total Greene Climacteric Scale (GCS) Score and GCS Subscores at Week 12|GCS: a 21 item evaluation of symptoms which asked participants how bothered they were with particular symptom at the moment. Each item was scored as 0 = Not at all, 1 = A little, 2 = Quite a bit, and 3 = Extremely. A total score was derived from the sum of the 21 items (range 0-63). GCS was also used to generate 6 individual scores (psychological symptoms [range 0-33], anxiety [range 0-18], depression [range 0-15], somatic symptoms [range 0-21], vasomotor symptoms [range 0-6], and sexual dysfunction [range 0-3]). A decrease in the total climacteric score indicated an improvement in symptoms.|Baseline and Week 12|Main study efficacy population included all participants who were randomized; had at least 1 dose of study medication; and had a baseline and at least 1 on therapy Greene Climacteric Scale (GCS) assessment or at least 1 on therapy Patient Global Impression (PGI) assessment.||Units on a Scale||Standard Error|Mean
766275|NCT00686257|Secondary|Dyspnea||During the first 3 hours of recruitment||||||
766065|NCT00683800|Secondary|Change From Baseline in Adjusted Means in the Hot Flush Severity Score at Month 6 and Month 12|Severity: mild (heat sensation without sweating); moderate (heat sensation with sweating; able to continue activity); severe (heat sensation with sweating; causing cessation of activity). Average daily severity of hot flushes= (1*Number of mild+2*Number of moderate+3*Number of severe)/(Total number of hot flushes). Days with no hot flushes: severity score=0. As it was derived from count data, there was no maximum; minimum score=0; higher values= worse outcomes. Adjusted mean: calculated using change from baseline=response variable, treatment=factor and baseline=covariate using observed cases.|Baseline, Month 6 and Month 12|MITT participants of the efficacy sub-study population who had non-missing average daily number of moderate and severe hot flushes. The assessment was done using observed values. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively.||Units on a Scale||Standard Error|Mean
766066|NCT00683800|Secondary|Change From Baseline in Adjusted Means in the Number of Moderate and Severe Hot Flushes at Month 6 and Month 12|The average daily number of moderate and severe hot flushes was calculated as the sum of the number of moderate and severe hot flushes on each day divided by the number of days with data. Moderate hot flushes: sensation of heat with sweating; able to continue activity; and severe hot flushes: sensation of heat with sweating; causing cessation of activity. Adjusted mean was calculated by using change from baseline as response variable, treatment as factor, and baseline as covariate using the observed cases.|Baseline, Month 6 and Month 12|MITT participants of the efficacy sub-study population who had non-missing average daily number of moderate and severe hot flushes. The assessment was done using observed values. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively.||Hot Flushes||Standard Error|Mean
766067|NCT00683800|Secondary|Median Time to the First Day of 3 Consecutive Days of at Least 50% Reduction in Hot Flushes|Time to response was defined as the time-to-first 50% reduction in the average daily number of moderate to severe hot flushes over 3 consecutive days.|Week 12|MITT population included all participants who were randomized into efficacy substudy, had at least 1 dose of study drug, had vasomotor symptoms recorded on at least 1 day of baseline period and at least 1 day of on-therapy period during initial 12 weeks of therapy.||Days||95% Confidence Interval|Median
766068|NCT00683800|Secondary|Percentage of Participants With at Least 75% Reduction From Baseline in the Number of Moderate and Severe Hot Flushes|The average daily number of moderate and severe hot flushes was calculated as the sum of the number of moderate and severe hot flushes on each day divided by the number of days with data. Moderate hot flushes: sensation of heat with sweating; able to continue activity; and severe hot flushes: sensation of heat with sweating; causing cessation of activity.|Baseline, Week 4 and Week 12|MITT population included all participants who were randomized into efficacy substudy, had at least 1 dose of study drug, had vasomotor symptoms recorded on at least 1 day of baseline period and at least 1 day of on-therapy period during initial 12 weeks of therapy. Assessment was done using last observation carried forward (LOCF) method.||Percentage of participants|||Number
766069|NCT00683800|Secondary|Percentage of Participants With at Least 50% Reduction From Baseline in the Number of Moderate and Severe Hot Flushes|The average daily number of moderate and severe hot flushes was calculated as the sum of the number of moderate and severe hot flushes on each day divided by the number of days with data. Moderate hot flushes: sensation of heat with sweating; able to continue activity; and severe hot flushes: sensation of heat with sweating; causing cessation of activity.|Baseline, Week 4 and Week 12|MITT population included all participants who were randomized into efficacy substudy, had at least 1 dose of study drug, had vasomotor symptoms recorded on at least 1 day of baseline period and at least 1 day of on-therapy period during initial 12 weeks of therapy. Assessment was done using last observation carried forward (LOCF) method.||Percentage of participants|||Number
766070|NCT00683800|Secondary|Number of Participants With a Minimal Clinically Meaningful Decrease in the Average Daily Number of Hot Flushes|A mean decrease from baseline of at least 5.35 moderate to severe hot flushes at week 12 in the participants was considered clinically meaningful.|Baseline and Week 12|MITT population included all participants who were randomized into efficacy substudy, had at least 1 dose of study drug, had vasomotor symptoms recorded on at least 1 day of baseline period and at least 1 day of on-therapy period during initial 12 weeks of therapy. Assessment was done using last observation carried forward (LOCF) method.||Participants|||Number
766071|NCT00683800|Primary|Number of Participants With All Adjudicated Ischemic Cardiovascular (CV) Events|Adjudicated ischemic cardiovascular events were a composite of: a) Coronary Heart Disease (CHD)-related death; b) New Myocardial Infarction (MI) (non-procedure-related MI); c) Documented new onset of unstable angina requiring hospitalization; d) Unscheduled coronary revascularization procedures (percutaneous coronary intervention) or bypass grafting.|Baseline up to Month 12|Safety population included all randomized participants who received at least 1 dose of study medication.||Participants|||Number
766072|NCT00683800|Primary|Change From Baseline in the Average Daily Severity of Hot Flushes at Week 12|Severity ranged from mild (sensation of heat without sweating); moderate (sensation of heat with sweating; able to continue activity) to severe (sensation of heat with sweating; causing cessation of activity). The average daily severity of hot flushes for each time period was calculated as (1*Number of mild+2*Number of moderate+3*Number of severe)/(Total number of hot flushes). For the days with no hot flushes, the severity score was set as 0. As this was derived from the count data, there was no maximum; the minimum score was 0; the higher values showed worse outcomes.|Baseline and Week 12|MITT population included all participants who were randomized into efficacy substudy, had at least 1 dose of study drug, had vasomotor symptoms recorded on at least 1 day of baseline period and at least 1 day of on-therapy period during initial 12 weeks of therapy. Assessment was done using last observation carried forward (LOCF) method.||Units on a Scale||Standard Error|Mean
766085|NCT00683852|Secondary|MADRS (Montgomery-Asberg Depression Rating Scale) Readmission Rate|MADRS readmission rate is defined as MADRS score<11. The 10-item Montgomery-Asberg Depression Rating Scale (MADRS), which measures depression severity over the past week, was completed by clinicians using an MGH structured interview. Each item is measured on a scale from 0 to 6, and the items are summed to find the total score. The total minimum score is 0 units on a scale and the total maximum score is 60 units on a scale, where higher scores indicate more severe depression.|12 weeks|||Participants|||Count of Participants
766276|NCT00686257|Secondary|Total Length of Time Requiring NPPV||during hospitalization (after recruitment)||||||
766277|NCT00686257|Secondary|Changes in Gas Exchange||during the first 24 hours of the study||||||
766073|NCT00683800|Primary|Change From Baseline in the Average Daily Severity of Hot Flushes at Week 4|Severity ranged from mild (sensation of heat without sweating); moderate (sensation of heat with sweating; able to continue activity) to severe (sensation of heat with sweating; causing cessation of activity). The average daily severity of hot flushes for each time period was calculated as (1*Number of mild+2*Number of moderate+3*Number of severe)/(Total number of hot flushes). For the days with no hot flushes, the severity score was set as 0. As this was derived from the count data, there was no maximum; the minimum score was 0; the higher values showed worse outcomes.|Baseline and Week 4|MITT population: All participants randomized into efficacy substudy, had at least 1 dose of study drug, had vasomotor symptoms recorded on at least 1 day of baseline period and at least 1 day of on-therapy period during initial 12 weeks of therapy. Assessment was done using LOCF method. 1 participant in each group did not have data till Week 4.||Units on a Scale||Standard Error|Mean
766074|NCT00683800|Primary|Change From Baseline in the Average Daily Number of Moderate to Severe Hot Flushes at Week 12|The average daily number of moderate and severe hot flushes was calculated as the sum of the number of moderate and severe hot flushes on each day divided by the number of days with data. Moderate hot flushes: sensation of heat with sweating; able to continue activity; and severe hot flushes: sensation of heat with sweating; causing cessation of activity.|Baseline and Week 12|MITT population included all participants who were randomized into efficacy substudy, had at least 1 dose of study drug, had vasomotor symptoms recorded on at least 1 day of baseline period and at least 1 day of on-therapy period during initial 12 weeks of therapy. Assessment was done using last observation carried forward (LOCF) method.||Hot Flushes||Standard Error|Mean
766075|NCT00683800|Primary|Change From Baseline in the Average Daily Number of Moderate to Severe Hot Flushes at Week 4|The average daily number of moderate and severe hot flushes was calculated as the sum of the number of moderate and severe hot flushes on each day divided by the number of days with data. Moderate hot flushes: sensation of heat with sweating; able to continue activity; and severe hot flushes: sensation of heat with sweating; causing cessation of activity.|Baseline and Week 4|Modified Intent-to-Treat(MITT) population: Participants randomized into efficacy substudy; at least 1 dose of study drug, vasomotor symptoms on at least 1 day of baseline period and 1 day of on-therapy period during initial 12 weeks. Last observation carried forward (LOCF) method was used. 1 participant in each group did not have data till Week 4.||Hot Flushes||Standard Error|Mean
766076|NCT00683826|Primary|Weight||at the end of each study treatment arm (six weeks)||||||
766077|NCT00683826|Secondary|Energy Expenditure||will be measure at the end of each treatment period (6 weeks)||||||
766078|NCT00683826|Primary|Effects on Weight||4 weeks|||kilograms||Standard Deviation|Mean
766079|NCT00683852|Other Pre-specified|Number of Patients With Treatment Emergent AEs in Two Treatment Groups - People Exclusively on Drug or Placebo Throughout the Study|Differences in the incidence of treatment emergent AEs between the treatment groups were examined and evaluated using descriptive statistics. This analysis compared AEs between the arms that received exclusively drug throughout the study or placebo throughout the study.|12 Weeks|||Patients|||Number
766080|NCT00683852|Other Pre-specified|Number of Patients With Treatment Emergent AEs in Two Treatment Groups - Placebo Non-Responders|Differences in the incidence of treatment emergent AEs between the treatment groups were examined and evaluated using descriptive statistics. This analysis focused on placebo non-responders in phase 1 and presented them by their treatment assignment in phase 2.|12 Weeks|Of the 138 phase 1 placebo non-responders, 14 dropped out in phase 2: 9 in the drug arm and 5 in the placebo arm. Therefore, 124 total placebo non-responders from phase 1 were included in the analysis.||Patients|||Number
766081|NCT00683852|Other Pre-specified|Treatment Emergent AEs in Two Treatment Groups - Safety Sample|Differences in the incidence of treatment emergent AEs between the treatment groups were examined and evaluated using descriptive statistics. In this analysis, AEs were summarized according to person-phase of occurrence. Each AE was attributed to the person and then to phase 1 or phase 2, depending on the initial date of onset.|12 Weeks|AEs were summarized according to person-phase of occurrence. Each AE will be attributed to the person and then to phase 1 or phase 2, depending on the initial date of onset. If the severity or other characteristic of the AE changes between phases, it can be counted in both phases. Also see Table 5 in Reference.||adverse events|participant-phases||Number
766082|NCT00683852|Secondary|Mean Change in Symptom Questionnaire (SQ)|The SQ, a 92-item (yes/no) self-rating questionnaire, includes 4 distress and 4 well-being subscales. There are 68 items for the distress subscales and 24 items for the well-being subscales. Each item has either a Yes/No or True/False answer. For the distress symptom score, add together the following items and score 1 when the answer is Yes/True: 1, 2, 3, 5, 6, 8, 11, 12, 15, 18, 20, 22, 24, 25, 26, 27, 28, 29, 30, 32, 33, 34, 36, 37, 39, 41, 42, 44, 45, 47, 48, 49, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 72, 73, 74, 75, 76, 77, 79, 80, 81, 82, 84, 85, 86, 87, 88, 90, 91, 92. Minimum score is 0 and maximum score is 68. A higher score indicates more distress symptoms. For the well-being subscale score, add together the following items and score 1 when the answer is No/False: 4, 7, 9, 10, 13, 14, 16, 17, 19, 21, 23, 29, 31, 35, 38, 40, 43, 46, 50, 51, 71, 78, 83, 89. Minimum score is 0 and maximum score is 24. A higher score indicates more well-being.|Baseline and 12 weeks|This analysis used observed cases rather than LOCF (last observation carried forward), so some participants were missing follow-up data.||units on a scale||Standard Deviation|Mean
766083|NCT00683852|Secondary|Mean Change in Clinical Global Impression of Severity (CGI-S)|The CGI-S scale was administered by clinicians based on assessment of the patient’s clinical status. They measured, based on history and scores on other instruments, depressive severity. It consists of one question scored on a seven-point scale (1 = normal to 7 = among the most severe), so a higher total score indicates greater depressive severity. The minimum score is 1, and the maximum score is 7.|Baseline and 12 weeks|This analysis used observed cases rather than LOCF (last observation carried forward), so some participants were missing follow-up data.||units on a scale||Standard Deviation|Mean
766084|NCT00683852|Secondary|Mean Change in MADRS (Montgomery-Asberg Depression Rating Scale) Score From Baseline to the End of Follow-up|The 10-item Montgomery-Asberg Depression Rating Scale (MADRS), which measures depression severity over the past week, was completed by clinicians using an MGH structured interview. Each item is measured on a scale from 0 to 6, and the items are summed to find the total score. The total minimum score is 0 units on a scale and the total maximum score is 60 units on a scale, where higher scores indicate more severe depression.|Baseline and 12 Weeks|||units on a scale||Standard Deviation|Mean
766086|NCT00683852|Primary|MADRS (Montgomery-Asberg Depression Rating Scale) Response Rate|The primary outcome was the difference in response rate (decrease in MADRS total score of at least 50%) using the SPCD (sequential parallel comparison design). The 10-item Montgomery-Asberg Depression Rating Scale (MADRS), which measures depression severity over the past week, was completed by clinicians using an MGH structured interview. Each item is measured on a scale from 0 to 6, and the items are summed to find the total score. The total minimum score is 0 units on a scale and the total maximum score is 60 units on a scale, where higher scores indicate more severe depression.|12 weeks|||Participants|||Count of Participants
766087|NCT00683878|Secondary|Adjusted Mean Change From Baseline in Total Body Weight (kg) Among Subjects With Baseline Body Mass Index (BMI) ≥ 27 kg/m^2 at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight among subjects with baseline body mass index (BMI) ≥ 27 kg/m^2 at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 8, 12, 16, 20, and 24 of the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing body weight values at baseline and Week 24 (LOCF) among subjects with baseline body mass index (BMI) ≥ 27 kg/m^2||kg||Standard Error|Mean
766088|NCT00683878|Secondary|Adjusted Mean Change From Baseline in Waist Circumference (cm) at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in waist circumference at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Waist circumference measurements were obtained during the qualification and lead-in periods and on Day 1 and Week 24 of the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing waist circumference values at baseline and Week 24 (LOCF)||cm||Standard Error|Mean
766089|NCT00683878|Secondary|Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Percent adjusted for baseline HbA1c. Therapeutic glycemic response is defined as HbA1c <7.0%. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin. Mean and standard error for percentage of participants were estimated by modified logistic regression model.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing values at baseline and Week 24 (LOCF)||Percentage of participants||Standard Error|Mean
766090|NCT00683878|Secondary|Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Fasting plasma glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 8, 12, 16, 20, and 24 in the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing FPG values at baseline and Week 24 (LOCF)||mg/dL||Standard Error|Mean
766091|NCT00683878|Secondary|Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 8, 12, 16, 20, and 24 of the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing body weight values at baseline and Week 24 (LOCF)||kg||Standard Error|Mean
766092|NCT00683878|Secondary|Adjusted Mean Change From Baseline in 120-minute Post-challenge Plasma Glucose (PPG) (mg/dL) at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. In post oral glucose tolerance test (OGTT), glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. PPG measurements were obtained on Day 1 and week 24 in the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing HbA1c values at baseline and Week 24 (LOCF)||mg/dL||Standard Error|Mean
766107|NCT00683904|Primary|Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose of Carboplatin in Combination With Ixabepilone, 32 mg/m^2|The MTD was defined as the highest dose evaluated for which less than one sixth of patients experience a DLT in Cycle 1. The recommended phase 2 dose is the MTD defined in Cycle 1, with consideration given to chronic cumulative toxicity occurring at later cycles.|Days 1 through 21 (Cycle 1)|All participants who received at least 1 dose of either ixabepilone or carboplatin||mg/min/mL|||Number
766093|NCT00683878|Primary|Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF])|HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 8, 12, 16, 20, and 24 in the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing HbA1c values at baseline and Week 24 (LOCF)||% of hemoglobin||Standard Error|Mean
766094|NCT00683904|Secondary|Total Body Clearance of Ixabepilone||Days 1 to 8 of Cycle 1 (21 days)|All participants who received ixabepilone and carboplatin and had adequate pharmacokinetic concentration profiles||Liters/hour||Standard Deviation|Mean
766095|NCT00683904|Secondary|Volume of Distribution at Steady State of Ixabepilone||Days 1 to 8 of Cycle 1 (21 days)|All participants who received ixabepilone and carboplatin and had adequate pharmacokinetic concentration profiles||Liters||Standard Deviation|Mean
766096|NCT00683904|Secondary|Area Under the Plasma Concentration-time Curve (AUC) From Time Zero Extrapolated to Infinite Time of Ixabepilone||Days 1 to 8 of Cycle 1 (21 days)|All participants who received ixabepilone and carboplatin and had adequate pharmacokinetic concentration profiles||ng*h/mL||Standard Deviation|Geometric Mean
766097|NCT00683904|Secondary|Time of Maximum Observed Plasma Concentration of Ixabepilone||Days 1 to 8 of Cycle 1 (21 days)|All participants who received ixabepilone and carboplatin and had adequate pharmacokinetic concentration profiles||Hours||Standard Deviation|Mean
766098|NCT00683904|Secondary|Maximum Observed Plasma Concentration of Ixabepilone||Days 1 to 8 of Cycle 1 (21 days)|All participants who received ixabepilone and carboplatin and had adequate pharmacokinetic concentration profiles||ng/mL||Standard Deviation|Geometric Mean
766099|NCT00683904|Secondary|Number of Participants at Each Response Evaluation Criteria in Solid Tumors (RECIST) Assessment|Tumor response was assessed using the RECIST assessment: Complete response (CR)=Disappearance of all clinical and radiologic evidence of target lesions; Partial response (PR)=At least 30% reduction in the sum of the longest diameters of all target lesions; Progressive disease (PD)=At least 20% increase in the sum of the longest diameters of all target lesions; Stable disease (SD)=Neither PR nor PD criteria were met.|Days 1 through 21 (Cycle 1)|All treated participants with measurable disease at baseline, as determined by investigator||Participants|||Number
766100|NCT00683904|Secondary|Number of Participants With Abnormalities in Weight and Eastern Cooperative Oncology Group (ECOG) Performance Status|Participants weighed same day as serum chemistry tests. Body surface area recalculated only if body weight changes >10%. ECOG criteria used to assess disease progression and affects on daily living abilities and to determine appropriate treatment and prognosis. Grade 1=Restricted physical activity but ambulatory and capable of light work; Grade 2=Ambulatory, capable of self care, but unable to carry out any work activities; Grade 3=Capable of limited self care, confined to bed or chair 50% or more of waking hours; Grade 4=Completely disabled, totally confined to bed or chair.|At screening of Cycle 1 (21 days) and Day 1 of Cycle 2 (Study day 22)|||Participants|||Number
766101|NCT00683904|Secondary|Number of Participants With Abnormalities in Blood Pressure and Heart Rate|Blood pressure and heart rate obtained before ixabepilone infusion, every 1 hour during and at the end of ixabepilone infusion, and at the end of carboplatin infusion in Cycle 1. For subsequent cycles, vital signs obtained before ixabepilone infusion, at the end of ixabepilone infusion, and at the end of carboplatin infusion. Any new or worsening clinically significant changes since last entry were recorded as appropriate AE or SAE.|At screening and Day 1 of Cycle 1 (21 days) and Day 1 of Cycle 2 (Study day 22)|||Participants|||Number
766102|NCT00683904|Secondary|Number of Participants With Abnormalities in Urine Testing Results by Worst CTC Grade|Toxicities graded according to CTC, Version 3. Protein Gr 1: <1.0 g/24 hrs (1+); Gr 2: 1.0 to 3.4 g/24 hrs (2+ to 3+ ); Gr 3: >=3.5 g/24 hrs (4+); Gr 4: Nephrotic syndrome. Note: + = qualitative measure of urine chemistry.|At screening and Days 8 and 15 of Cycle 1 (21 days)|||Participants|||Number
766103|NCT00683904|Secondary|Number of Participants With Abnormalities in Serum Chemistry Laboratory Values by Worst CTC Grade|ULN=upper limit of normal; LLN=lower limit of normal. Alkaline phosphatase=ALP(LLN=115; ULN=359) (U/L); alanine aminotransferase=ALT (LLN=8; ULN=42)(U/L); aspartate aminotransferase=AST (LLN=13; ULN=33) (U/L); albumin (LLN=3.7; ULN=5.2)(g/dL); bilirubin (LLN=0.3; ULN=1.2)(mg/dL); calcium (LLN=8.7; ULN=10.3)(mg/dL); creatinine (LLN=0.6; ULN=1.1)(mg/dL); potassium (LLN=3.6; ULN=4.9) (mEq/L); sodium (LLN=138; ULN=146) (mEq/L)|At screening and Days 8 and 15 of Cycle 1 (21 days)|All participants who received at least 1 dose of either ixabepilone or carboplatin||Participants|||Number
766104|NCT00683904|Secondary|Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade|"LLN=lower level of normal; ULN=upper level of normal. Hemoglobin (g/dL; LLN=11.3; ULN=14.9); leukocytes (*10^3 c/uL; LLN=4.1; ULN=6.1); lymphocytes (*10^3 c/uL); neutrophils (absolute), neutrophils + bands (*10^3 c/uL); platelet count (*10^9 c/L; LLN=131; ULN=365)
Appendix 7.1.2"|At screening and Days 8 and 15 of Cycle 1 (21 days)|All participants who received at least 1 dose of either ixabepilone or carboplatin||Participants|||Number
766105|NCT00683904|Secondary|Number of Participants With Grade 3 or Greater Treatment-related AEs|An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with treatment. AEs graded according to CTC, Version 3.0. Gr 1=Mild; Gr 2=Moderate; Gr 3=Severe; Gr 4=Life-threatening. Treatment-related comprises certainly, probably, and possibly related and of unknown relationship to study drug.|Days 1 through 21 (Cycle 1)|All subjects who received at least 1 dose of either ixabepilone or carboplatin||Participants|||Number
766106|NCT00683904|Secondary|Number of Participants With Death as Outcome, Treatment-related Serious Adverse Events (SAEs), SAEs, Adverse Events (AEs), and Treatment-related AEs Leading to Discontinuation|An SAE is any untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires inpatient hospitalization or prolongs existing hospitalization. An AE is any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. Treatment-related comprises certainly, probably, and possibly related and of unknown relationship to study drug.|Days 1 through 21 (Cycle 1)|All participants who received at least 1 dose of either ixabepilone or carboplatin||Participants|||Number
766108|NCT00683904|Primary|Number of Participants With Dose-limiting Toxicity (DLT)|DLT is defined as any of the following: Common Terminology Criteria (CTC), Version 3, Grade(Gr) 4 neutropenia (absolute neutrophil count <500 cells/mm^3) for at least 5 days or febrile neutropenia; Gr 4 thrombocytopenia (<25,000 cells/mm^3 or bleeding needing platelet transfusion); Gr 3 or 4 nausea, vomiting, or diarrhea, despite medical intervention; any other drug-related Gr 3 or 4 nonhematologic toxicity, except Gr 3 injection site reaction, fatigue/asthenia, transient arthralgia/myalgia, or transient electrolytes abnormal. Gr 1=Mild; Gr 2=Moderate; Gr 3=Severe; Gr 4=Life-threatening.|Days 1 through 21 (Cycle 1)|All participants who received at least 1 dose of either ixabepilone or carboplatin||Participants|||Number
766109|NCT00683917|Primary|The Primary Outcome Measure is the PK Characteristics of 25 mg and 50 mg Proellex.||4 months|Study prematurely terminated|||||
766110|NCT00683930|Secondary|Duration of Prednisone Maintenance Dosing|The duration of prednisone maintenance dosing was defined as the number of days that subjects maintained a prednisone dose of not more than 10 mg/day in the absence of new persistent lesions.|52 weeks|Intent-to-treat population. Analysis population (AP): Placebo = 36; MMF 2 g/day = 21; MMF 3 g/day = 37; MMF Groups Combined (2 g/day or 3 g/day) = 58.||Days||Inter-Quartile Range|Median
766111|NCT00683930|Secondary|Time to Sustained Response|Time to sustained response is defined as the week the subject first demonstrates both of the conditions of responder status provided the conditions are maintained through to study termination at Week 52. If a subject does not have a sustained response, time to sustained response is censored on the last day of the study.|up to 52 weeks|Intent-to-treat population. Analysis population (AP): Placebo = 36, subjects censored = 20; MMF 2 g/day or 3 g/day = 58, subjects censored = 23.||Weeks||Full Range|Median
766112|NCT00683930|Secondary|Time to Initial Response|Time to initial response defined as the time that the subject first demonstrated responder status (defined as no new persistent lesions and prednisone dose of not more than 10 mg/day from Week 48 until study termination at Week 52)|up to 52 weeks|Intent-to-treat population. Analysis population (AP): Placebo = 36, subjects censored = 7; MMF 2 g/day or 3 g/day = 58, subjects censored = 10.||Weeks||Inter-Quartile Range|Median
766113|NCT00683930|Primary|Percentage of Patients Achieving Responder Status at Week 52|The proportion of subjects achieving responder status (defined as no new persistent lesions and prednisone dose of not more than 10 mg/day from Week 48 until study termination at Week 52) in the two active treatment groups combined (2 g/day and 3 g/day mycophenolate mofetil) compared with the placebo group|52 weeks|Intent-to-treat population. Analysis population (AP): Placebo = 36; MMF 2 g/day or 3 g/day = 58.||Percentage of Participants|||Number
766114|NCT00684021|Primary|Regional Left Ventricular Function (Border Zone Wall Motion)|Two of two calculated values of regional left ventricular function assessed via cardiac MRI. The border zone is defined as those regions adjacent to the infarct zone in which the cMRI signal intensity enhancement were in the 10%-75% range. Values reported represent the change in wall motion over time in the border zone of the infarct from baseline to six months.|Measured at Baseline and Month 6|Values reported represent the change in wall motion over time in the border zone of the infarct from baseline to six months.||mm||Standard Deviation|Mean
766115|NCT00684021|Primary|Regional Left Ventricular Function (Infarct Zone Wall Motion)|One of two calculated values of regional left ventricular function as assessed via cardiac MRI. The infarct zone is defined as the cMRI segments with the largest 2 signal intensity enhancement measures with gadolinium (using a 17-segment model).Values reported represent the change in wall motion over time in the infarct zone from baseline to six months.|Measured at Baseline and Month 6|Only participants with both baseline and 6 month MRI images available are included. Values reported represent the change in wall motion over time in the infarct zone from baseline to six months.||mm||Standard Deviation|Mean
766116|NCT00684021|Secondary|Infarct Volume|Infarct volume(mL). Values reported represent the change in infarct volume from baseline to six months.|Measured at Baseline and Month 6|"Only participants with both baseline and 6 month MRI images available are included.
Values reported represent the change in infarct volume from baseline to six months."||mL||Standard Deviation|Mean
766117|NCT00684021|Secondary|End Systolic Volume Index|Left ventricular end systolic volume index. Values reported represent the change in LV end systolic volume index from baseline to six months.|Measured at Baseline and Month 6|"Only participants with both baseline and 6 month MRI images available are included.
Values reported represent the change in LV end systolic volume index from baseline to six months."||mL/m2||Standard Deviation|Mean
766118|NCT00684021|Secondary|End Diastolic Volume Index|Left ventricular end diastolic volume index. Values reported represent the change in LV end diastolic index from baseline to six months.|Measured at Baseline and Month 6|"Only participants with both baseline and 6 month MRI images available are included.
Values reported represent the change in LV end diastolic index from baseline to six months."||mL/m2||Standard Deviation|Mean
766119|NCT00684021|Secondary|Left Ventricular Mass|Left ventricular mass (LV mass. Values reported represent the change in LV mass from baseline to six months.|Measured at Baseline and Month 6|"Only participants with both baseline and 6 month MRI images available are included.
Values reported represent the change in LV mass from baseline to six months."||g||Standard Deviation|Mean
766120|NCT00684021|Secondary|Clincal and Safety Outcomes|Number of events -death, reinfarction, repeat revascularizations (target and nontarget vessels) hospitalizations for heart failure, ICD placements|Measured from baseline to six months.|All randomized patients were followed for clinical outcomes.||events|||Number
766121|NCT00684021|Primary|Global Left Ventricular Function|Left ventricular ejection fraction (global) as assessed via cardiac MRI. Values reported represent the change in Global EF from baseline to six months.|Measured at Baseline and Month 6|"Only participants with both baseline and 6 month MRI images available are included.
Values reported represent the change in Global EF from baseline to six months."||percentage of ejection fraction||Standard Deviation|Mean
766122|NCT00684047|Secondary|Prevalence of Treatment Failures|The cumulative proportions of subjects who did not achieve hemostasis during the 10- minute observation period in Primary Part (II)|10 minutes from the start of treatment application at the target bleeding site|intent to treat population||percentage of participants|||Number
766123|NCT00684047|Secondary|Proportions of Subjects Achieving Hemostasis|The cumulative proportions of subjects who achieved hemostasis during the 10- minute observation period in Primary Part (II)|10 minutes from the start of treatment application at the target bleeding site|intent to treat population||percentage of participants|||Number
766124|NCT00684047|Primary|The Primary Efficacy Endpoint is Time to Hemostasis.|The primary efficacy endpoint of the study is time to hemostasis (TTH), measured in minutes from the start of treatment application (TStart) at the TBS to the achievement of hemostasis at that site or to the end of the 10-minute observational period if hemostasis has not yet been achieved.|The start of treatment application at the target bleeding site (TBS) to the achievement of hemostasis at that site or to the end of the 10-minute observational period when the hemostasis has not yet been achieved.|||percentage of subjects|||Number
766125|NCT00684060|Primary|Regional Left Ventricular Function (Border Zone Wall Motion)|Two of two calculated values of regional left ventricular function assessed via cardiac MRI. The border zone is defined as those regions adjacent to the infarct zone in which the cMRI signal intensity enhancement were in the 10%-75% range. Values reported represent the change in wall motion over time in the border zone of the infarct from baseline to six months.|Measured at Baseline and Month 6|"Five patients were excluded from analysis due to incomplete signal intensity enhancement data (1) or lack of a signal intensity enhancement signal in the border zone (4).
Values reported represent the change in wall motion over time in the border zone of the infarct from baseline to six months."||mm||Standard Deviation|Mean
766126|NCT00684060|Primary|Regional Left Ventricular Function (Infarct Zone Wall Motion)|One of two calculated values of regional left ventricular function as assessed via cardiac MRI. The infarct zone is defined as the cMRI segments with the largest 2 signal intensity enhancement measures with gadolinium (using a 17-segment model).Values reported represent the change in wall motion over time in the infarct zone from baseline to six months.|Measured at Baseline and Month 6|"Only participants with both baseline and 6 month MRI images available are included. One patient was excluded from the analysis due to incomplete signal intensity enhancement data.
Values reported represent the change in wall motion over time in the infarct zone from baseline to six months."||mm||Standard Deviation|Mean
766127|NCT00684060|Secondary|Infarct Volume|Infarct volume(mL). Values reported represent the change in infarct volume from baseline to six months.|Measured at Baseline and Month 6|"Only participants with both baseline and 6 month MRI images available are included.
Values reported represent the change in infarct volume from baseline to six months."||mL||Standard Deviation|Mean
766128|NCT00684060|Secondary|End Systolic Volume Index|Left ventricular end systolic volume index. Values reported represent the change in LV end systolic volume index from baseline to six months.|Measured at Baseline and Month 6|"Only participants with both baseline and 6 month MRI images available are included.
Values reported represent the change in LV end systolic volume index from baseline to six months."||mL/m2||Standard Deviation|Mean
766129|NCT00684060|Secondary|End Diastolic Volume Index|Left ventricular end diastolic volume index. Values reported represent the change in LV end diastolic index from baseline to six months.|Measured at Baseline and Month 6|"Only participants with both baseline and 6 month MRI images available are included.
Values reported represent the change in LV end diastolic index from baseline to six months."||mL/m2||Standard Deviation|Mean
766130|NCT00684060|Secondary|Left Ventricular Mass|Left ventricular mass (LV mass. Values reported represent the change in LV mass from baseline to six months.)|Measured at Baseline and Month 6|"Only participants with both baseline and 6 month MRI images available are included.
Values reported represent the change in LV mass from baseline to six months."||g||Standard Deviation|Mean
766131|NCT00684060|Secondary|Combined Endpoint|Combined endpoint: first of death, reinfarction, repeat revascularization, and hospitalization for heart failure. This is measured as the number of events by treatment group over the 6 month follow up period.|Measured at Baseline and Month 6|All randomized patients were followed for clinical outcomes. However the paucity of events precluded a reliable time to event analysis.||events|||Number
766132|NCT00684060|Primary|Global Left Ventricular Function|Left ventricular ejection fraction (global) as assessed via cardiac MRI. Values reported represent the change in Global EF from baseline to six months.|Measured at Baseline and Month 6|"Only participants with both baseline and 6 month MRI images available are included.
Values reported represent the change in Global EF from baseline to six months."||percentage of ejection fraction||Standard Deviation|Mean
766133|NCT00684073|Primary|Subject's Self Assessment Using 10 cm Visual Analogue Scale (VAS) of Overall Preference for One of the Two Buprenorphine-based Maintenance Therapies (Suboxone® or Subutex®).|"Score of 0 = Not satisfied at all; Score of 10 = Totally satisfied"|Each treatment Day (post-dose on days 1-5)|Intent to Treat (ITT) - each day's results were based on number of subjects who had a Day 1 visit.||centimeters||Standard Deviation|Mean
766134|NCT00684983|Secondary|Adverse Event Profile of Capecitabine and Lapatinib With and Without IMC-A12 (Using NCI CTCAE v3.0)|"All eligible patients that have initiated treatment will be considered evaluable for assessing adverse event rate(s) according to CTCAE v3.0 within each treatment arm. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration.
4/19 (21.05%) 14/45 (31.11%)"|Baseline to 30 days past end of treatment|||percentage of patients with AEs|||Number
766135|NCT00684983|Secondary|Duration of Response|Distribution estimated by the Kaplan-Meier (1958) method for each treatment arm.|Up to 5 years|Evaluable patients that had a response to treatment drug||Months||Full Range|Median
766136|NCT00684983|Secondary|Confirmed Tumor Response, Defined as Either a Complete Response (CR) or Partial Response (PR) Noted as the Objective Status on 2 Consecutive Evaluations at Least 6 Weeks Apart, Assessed by Response Evaluation Criteria for Solid Tumors (RECIST)||Up to 5 years|Includes patients with at least one disease assessment at least 6 weeks after registration.||% of evaluable participants||95% Confidence Interval|Number
766137|NCT00684983|Secondary|Time to Treatment Failure|Distribution estimated by the Kaplan-Meier (1958) method for each treatment arm.|From the date of randomization to the date at which the patient is removed from treatment due to progression, adverse events, or refusal, up to 5 years|||Months||Full Range|Median
766138|NCT00684983|Secondary|Overall Survival|Median Survival time (months)|From randomization to death due to any cause, up to 5 years|All evaluable patients||Months||Full Range|Median
766139|NCT00684983|Primary|Progression-free Survival (PFS)|Analysis of the primary endpoint, PFS, will be performed using Cox regression with treatment group as a single covariate.|From randomization to the earliest date of documentation of disease progression, up to 5 years|First 8 patients in Arm B are from safety cohort, they are not eligible for primary end point||Median survival and CI in months||95% Confidence Interval|Median
766140|NCT00684996|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|Patients were assessed for the first 8 weeks for dose-limiting toxicities, then assessed for adverse events after every cycle (1 cycle = 28 days) of protocol treatment, up to 3 years|Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.||Participants|||Number
766141|NCT00684996|Primary|Response Rate According to Response Evaluation Criteria in Solid Tumors (RECIST), Including Confirmed and Unconfirmed Complete and Partial Responses (Phase II)|Complete Response (CR) is a complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Partial Response (PR) applies only to patients with at least one measurable lesion. Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of nonmeasurable disease. No new lesions.|Up to 3 years|The study was permanently closed to accrual on April 1, 2009, due to drug supply issues.|||||
766142|NCT00684996|Primary|Overall Survival (Phase II)|Measure from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|From date of registration to date of death due to any cause, assessed up to 3 years|The study was permanently closed to accrual on April 1, 2009, due to drug supply issues.|||||
766143|NCT00684996|Primary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug, Graded According to NCI CTCAE Version 3.0 (Phase II)|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|Up to 3 years|The study was permanently closed to accrual on April 1, 2009, due to drug supply issues.|||||
766144|NCT00684996|Primary|Progression-free Survival (Phase II)|Measured from date of registration to date of first observation of progressive disease, symptomatic deterioration or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.|From date of registration to date of first observation of progressive disease, systemic deterioration, or death due to any cause, assessed up to 3 years|The study was permanently closed to accrual on April 1, 2009, due to drug supply issues.|||||
766145|NCT00684996|Primary|Maximum Tolerated Dose of Bevacizumab , Based on Incidence of Dose-limiting Toxicity (DLT) Graded According to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (Phase I)||Up to 8 weeks|The study was permanently closed to accrual on April 1, 2009, due to drug supply issues.|||||
766146|NCT00685035|Secondary|Patients' Perceived Comfort Using the Different Settings for the Vest Device|"Following each HFCWC session on day 1 and day 4, subjects completed a questionnaire that rated the comfort and efficacy of each HFCWC session using a 5-point scale. The questionnaire was entitled Post-Therapy Questionnaire. Scale range for comfort ranged from 1 (very uncomfortable) to 3 (neutral) to 5 (very comfortable). Scale range for how effective the HFCWC session was ranged from 1 (minimally effective) to 3 (neutral) to 5 (very effective)."|Immediately following each airway clearance therapy on day 1 and day 4|power calculation not performed for secondary outcomes||units on a scale||Full Range|Median
766147|NCT00685035|Secondary|Rheology and in Vitro Cough Transportability of Sputum Produced Immediately Following Airway Clearance Therapy Session|"Sputum was collected during the 15 minutes immediately following HFCWC sessions on day 1 and day 4. Half the subjects performed higher-pressure/mixed frequency HFCWC on Day 1 followed by lower pressure/mid-frequency HFCWC on Day 4. The other half of subjects performed lower pressure/mid-frequency on Day 1 followed by higer pressure/mixed-frequency on Day 4. Samples were studied with a rheometer (AR1000, TA Instruments, New Castle, Delaware) to assess the dynamic frequency range of stress-strain of a 20 microliter sputum sample over driving frequencies of 1–100 rad/s. Shear storage modulus (G') and shear loss modulus (G) were determined from these curves after nondestructive creep transformation. G' (or dynamic elasticity) measures stored energy and is a property of ideal solids. G is directly proportional to viscosity (viscosity x frequency) and is a property of ideal liquids."|Sputum produced during the 15 minutes immediately following airway clearance therapy sessions on day 1 and day 4|power calculation not performed for secondary outcomes||dynes/cm^2||Full Range|Median
766148|NCT00685035|Secondary|Pre vs. Post Therapy Spirometry|Spirometry was performed prior to, and immediately following, all HCWC sessions on Day 1. Spirometry was performed immediately prior to, and immediately following, all HFCWC sessions on Day 4. Spirometry was performed according to American Thoracic Society/European Respiratory Society standards.|Prior to and following each airway clearance therapy session on days 1 and 4|Power calculation not performed for secondary outcomes.||ml||Standard Deviation|Mean
766149|NCT00685035|Primary|Sputum Wet and Dry Weight|"All sputum expectorated during all HFCWC sessions was collected in a pre-weighed specimen container and immediately sealed. Half the subjects used higher pressure/mixed frequency on day 1 followed by lower pressure/mid-frequency on day 4. Half the patients performed lower pressure/mid-frequency on day 1 followed by higher pressure/mixed frequency on day 4. All specimens were immediately centrifuged at 21,150 g for 15 min at 4°C, and the supernatant was completely removed to eliminate saliva. The sputum wet weight was calculated after re-weighing the container with the sputum pellet. The container was then left open in an oven with the temperature set at 65°C for a minimum of 3 days to allow for complete desiccation. The sputum “dry weight” was calculated after re-weighing the container."|Produced during each airway clearance therapy session on days 1 and 4|In a previous study with similar design,21 the standard deviation for the difference in the mean sputum wet weight between treatment arms was 4.6 g. Assuming the same standard deviation for the current study, enrollment of 16 subjects provided an 80% chance of detecting a 3.5-g difference in the sputum wet weights at a significance level of .05.||grams||Full Range|Median
766150|NCT00685139|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 16, 24, 36, 48, 60 and 72 hours after drug administration.|||ng-hr/mL||Standard Deviation|Mean
766151|NCT00685139|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that the drug reaches in the plasma.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 16, 24, 36, 48, 60 and 72 hours after drug administration.|Pharmacokinetic analyses are based on 33 out of 34 subjects who completed this study. One subject elected to withdraw prior to the study hour 2 blood sample collection during period II.||ng/mL||Standard Deviation|Mean
766152|NCT00685165|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 18, 24, 36, 48, 60 and 72 hours after drug administration.|Plasma concentration data for 21 of 22 participants were used in the statistical analysis. One subject dropped from the study before Period II dosing due to an adverse event.||ng-hr/mL||Standard Deviation|Mean
766153|NCT00685165|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 18, 24, 36, 48, 60 and 72 hours after drug administration.|Plasma concentration data for 21 of 22 participants were used in the statistical analysis. One subject dropped from the study before Period II dosing due to an adverse event.||ng-hr/mL||Standard Deviation|Mean
766154|NCT00685165|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that the drug reaches in the plasma.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 18, 24, 36, 48, 60 and 72 hours after drug administration.|Plasma concentration data for 21 of 22 participants were used in the statistical analysis. One subject dropped from the study before Period II dosing due to an adverse event.||ng/mL||Standard Deviation|Mean
766155|NCT00685178|Secondary|Voucher Earnings|"Voucher earnings used as a measurement of contigency management (CM) or operate conditioning. Volunteers were rewarded vouchers of escalating monetary value for cocaine abstinence, as indicated by a cocaine negative urine sample. The first cocaine negative urine earned a $2.50 voucher, and the value increased by $1.50 for each subsequent cocaine negative sample. Volunteers were awarded a bonus of $10.00 for every three consecutive cocaine negative urine samples. Urine samples were collected 3 times per week, and vouchers were attainable between Weeks 8 and 20.
Contingency management as a measurement of operant conditioning in which positive reinforcement is applied (in this case vouchers of monetary value) and cocaine abstinence"|12 weeks (Weeks 8-20)|||Dollars||Standard Error|Mean
766156|NCT00685178|Primary|Proportion of Cocaine Positive Urine Samples Per Treatment Condition|Percentage of cocaine positive urine samples as measured by Preston new use rule (50% reduction in cocaine metabolites from previous urine)|Urine samples collected 3 times weekly from week 1 through 26|This study utilized an Intent-to-Treat (ITT) analysis. The ITT analysis includes all volunteers who signed informed consent, were randomized into the study's treatment conditions, and took at least 1 dose of study medication.||percentage of positive urine samples|||Number
766157|NCT00685295|Secondary|Occurrence of Untoward Opioid Side Effects|Subjects were monitored for any signs of untoward opioid side effects.|120 minutes|||Participants|||Count of Participants
766158|NCT00685295|Primary|Pain Reduction|Number of subjects who reached pain reduction. A subject was deemed to have reached pain reduction if there was a two-point drop in pain scale (0-10).|60 minutes|||Participants|||Count of Participants
766159|NCT00685295|Primary|Time to Analgesia|Time it took for subjects to achieve a pain score reduction of 2 units (on a 0 to 10 scale)|60 minutes|||minutes||Inter-Quartile Range|Median
766160|NCT00685334|Secondary|Treatment Compliance|Total number of randomized patients that completed the full 12 weeks of treatment.|Measured at Week 12||||||
766161|NCT00685334|Secondary|Medication Side Effects|Common side effects include sedation, dizziness, and headache for patients on olanzapine and akathisia, anxiety, dizziness and blurred vision for patients receiving aripriprazole.|Measured at Week 12||||||
766162|NCT00685334|Primary|Tolerability|This study addressed the benefits, tolerability, acceptability, safety, and appropriate dosage of olanzapine and aripiprazole, as determined by clinical evaluation and self report. The outcome measure reported here is the number of patients who did not experience untoward side effects while taking the medication.|Measured at Week 12|Data was not available for all 22 participants.||Participants|||Number
766163|NCT00685334|Primary|Change From Baseline in Weight (Lbs.) at 12 Weeks|This study looked at change in weight before and after medication use.|baseline and 12 weeks|||lbs||Standard Deviation|Mean
766164|NCT00685373|Secondary|Pharmacokinetics|Mean Clearance from serum in Liter per Day (CLD) in adult participants >=18, pediatric participants <18 with body weight >40 kg and pediatric participants <18 with body weight <=40 kg.|Every 8 weeks during the course of the trial for at least 6 months with a maximum duration of 2 years|Safety population defined as all participants who received at least 1 dose of study drug. 3 participants were excluded because dosing information was not available at the time of analysis.||L/day||Standard Deviation|Mean
766165|NCT00685373|Secondary|Immunogenicity of Canakinumab (ACZ885)|The number of participants who tested positive for anti-ACZ885 antibodies using the Biacore Assay at the end of the study.|Every 8 weeks during the course of the trial for at least 6 months with a maximum duration of 2 years|Safety Population defined as all participants who received at least one dose of study drug and were tested for anti-ACZ885 antibodies at the end of the study.||participants|||Number
766186|NCT00685659|Primary|Percent Days Abstinent|Percent of days during the follow up that participant was abstinent from Alcohol and Cocaine|3 months (approximately study days 1 - 90)|N's represent the participants at three months for whom complete Time Line Follow Back data was available.||percentage of days||Standard Error|Mean
766187|NCT00685659|Primary|Percent Days Cocaine Use|Percent of days during the follow up that there was any cocaine use|24 months (approximately study days 547 - 730)|N's represent the participants at three months for whom complete Time Line Follow Back data was available.||percentage of days||Standard Error|Mean
766166|NCT00685373|Secondary|The Percentage of Participants Without Disease Relapse as Determined by the Physician's Global Assessment of Autoinflammatory Disease Activity, Assessment of Skin Disease and Inflammation Markers.|"Disease relapse following complete response is defined as inflammation markers: C-Reactive Protein (CRP) and/or Serum Amyloid A (SAA) result > 30 mg/L AND Physician's Global Assessment of Autoinflammatory Disease Activity > minimal or Physician's Global Assessment >= minimal AND Skin Disease Assessment > minimal.
Physician's Global Assessment of Autoinflammatory Disease Activity and Skin Disease Assessment (urticarial skin rash) are completed by the investigator using a 5 point rating scale: absent, minimal, mild, moderate and severe."|Every 8 weeks during the course of the trial for at least 6 months with a maximum duration of 2 years|Safety Population defined as all participants who had at least one dose of study drug and were included in the Relapse Assessment.||Percentage of participants|||Number
766167|NCT00685373|Primary|The Number of Participants With Adverse Events (AEs), Death, Serious Adverse Events (SAEs), Discontinuation of Study Drug Due to an AE, Infections and Infestations and Injection Site Reactions|The number of participants with Adverse Events and Infections & Infestations are regardless of study drug relationship by primary system organ class preferred term equal and/or greater than 2% in any group. The number of participants with mild injection site reactions= mild reactions observed on at least one occasion but no moderate or severe reactions. The number of participants with moderate injection site reactions= moderate reactions observed on at least one occasion but no severe reactions.|2 years depending on when the participant enters the study|Safety Population defined as all participants who received at least one dose of study drug.||participants|||Number
766168|NCT00685399|Secondary|Number of Participants Who Were Able to Re-induce a Remission if a Flare-up Occurs|A flare was defined as an increase of inflammation in either eye so that the anterior chamber cell score or the vitreous haze score become 1+ or greater. Vitreous haze was evaluated with an indirect ophthalmoscope and a hand-held 20-diopter lens. Haze is defined as a reduction in the clarity of fundus details seen through the vitreous, the degree of haze was quantified using standard National Eye Institute (NEI) photographs. The standard photographs provide a grading scale with photographs of fundi with vitreous haze grades “0” (zero), “trace” (which counts as 0.5+), 1+, 2+, 3+, and 4+. If the amount of vitreous haze appears to fall between two integer grades, the value would be recorded as halfway between the grades. The analysis was not conducted due to small sample size, insufficient number of participants and low initial doses; limited conclusions were drawn about dose response relationship leading to non summarization of results.|Day 1 to Day 57|PPAS consisted of all participants who received study drug, completed the treatment phase of the trial without clinically significant protocol deviations and have at least one post-baseline assessment for one of the outcomes that define participants who respond.|||||
766169|NCT00685399|Secondary|Number of Participants With Remission in Uveitis|Participants with uveitis who were able to stop all topical and systemic topical corticosteroids in both eyes after the first course of one or two doses by Day 57 visit . The analysis was not conducted due to small sample size, insufficient number of participants and low initial doses; limited conclusions were drawn about dose response relationship leading to non summarization of results.|Baseline (Day 1) up to Month 8|PPAS consisted of all participants who received study drug, completed the treatment phase of the trial without clinically significant protocol deviations and have at least one post-baseline assessment for one of the outcomes that define participants who respond.|||||
766170|NCT00685399|Secondary|Number of Participants Who Were Able to Induce a Remission in Uveitis|Participants with uveitis who were able to stop all topical and systemic topical corticosteroids in both eyes by Day 57 visit after the first course of one or two doses of AIN457 were to be categorized as nonresponders and were to be discontinued from the study at the Day 85 visit. The analysis was not conducted due to small sample size, insufficient number of participants and low initial doses; limited conclusions were drawn about dose response relationship leading to non summarization of results.|Day 1 to Day 85|PPAS consisted of all participants who received study drug, completed the treatment phase of the trial without clinically significant protocol deviations and have at least one post-baseline assessment for one of the outcomes that define participants who respond.|||||
766171|NCT00685399|Secondary|Number of Participants With Reduction in Oral Prednisone or Topical Corticosteroid and Other Immunosuppressant Drugs|Participants intake of oral prednisone or topical corticosteroid and other immunosuppressant drugs was reduced if participant was on up to 1.5 mg/kg/day dose of prednisone during the week prior to Day 1 or whom the resumption of prednisone was not considered the appropriate systemic therapy by investigator or who have never been on systemic immunosuppressive therapy and whose uveitis was so severe that, in the clinician’s judgment, prednisone at a dose of 1.0-1.5 mg/kg/day alone will be insufficient to control the uveitis or participant with HLA-B27-associated anterior uveitis who would ordinarily be started on systemic prednisone. The analysis was not conducted due to small sample size, insufficient number of participants and low initial doses; limited conclusions were drawn about dose response relationship leading to non summarization of results.|Baseline (Day 1) up to Month 8|PPAS consisted of all participants who received study drug, completed the treatment phase of the trial without clinically significant protocol deviations and have at least one post-baseline assessment for one of the outcomes that define participants who respond.|||||
766172|NCT00685399|Secondary|Number of Complete Responders in Cohort 2, 3 and 6 at Day 57|A “complete responder” was defined as a participant who was able to stop all topical and systemic corticosteroids in both eyes and maintain remission of uveitis (=remains a responder as defined above) lasting at least 1 week (since stopping corticosteroids, if corticosteroids were given).|Day 1 (Baseline), Day 57|PPAS consisted of all participants who received study drug, completed the treatment phase of the trial without clinically significant protocol deviations and have at least one post-baseline assessment for one of the outcomes that define participants who respond.||Participants|||Number
766188|NCT00685659|Primary|Percent Days Cocaine Use|Percent of days during the follow up that there was any cocaine use|18 months (approximately study days 366 - 546)|N's represent the participants at three months for whom complete Time Line Follow Back data was available.||percentage of days||Standard Error|Mean
766189|NCT00685659|Primary|Percent Days Cocaine Use|Percent of days during the follow up that there was any cocaine use|12 months (approximately study days 271 - 365)|N's represent the participants at three months for whom complete Time Line Follow Back data was available.||percentage of days||Standard Error|Mean
766278|NCT00686257|Secondary|Changes in Vital Signs|At initiation;30 minutes, 1 hour, 3 hours and 24 hours after NPPV initiation|during the first 24 hours of the study||||||
766173|NCT00685399|Secondary|Number of Responders in Cohort 1, 2, 3 and 6 at Day 57|A “responder” was defined as a participant who fulfilled at least one of the 3 criteria compared to baseline: 1. Increase in visual acuity by at least 15 letters using Early Treatment Diabetic Retinopathy Study method, no increase in daily prednisone dose compared to week 1 and without worsening of uveitis. 2. Decrease in vitreous haze by 2 steps or more or for participants with anterior uveitis, resolution of the anterior chamber inflammation (i.e., no cells or only a rare cell in the anterior chamber (score 0 or trace (0.5+)), use measurement before dilation), no increase in daily prednisone dose compared to week 1 and without any worsening of uveitis.3 For those participant on a. >20 mg/day of prednisone during week 1: Reduction in daily prednisone dose to 10 mg/day or less. b. ≤20 mg/day of prednisone during week 1: Reduction in daily prednisone dose to 0 mg/day. c. topical corticosteroids during week 1: Reduction in daily topical corticosteroid dose to 0 during the last 2 weeks.|Day 1 (Baseline), Day 57|The Per Protocol Analysis Set (PPAS) consisted of all participants who received study drug, completed the treatment phase of the trial without clinically significant protocol deviations and have at least one post-baseline assessment for one of the outcomes that define participants who respond.||Participants|||Number
766174|NCT00685399|Primary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Who Died|AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.|Day 1 to Day 603|Safety Analysis Set (SAS) consisted of all participants who received at least one dose of study drug and had at least one post–baseline safety assessment. All safety evaluations were carried out on the safety analysis set.||participants|||Number
766175|NCT00685477|Secondary|Gallbladder Ejection Fraction (GBEF) as a Percent for Each Infusion Method||15, 30, 45 and 60 minutes post-infusion|Some participants were excluded from analyses due to location testing procedures||percentage||Standard Deviation|Mean
766176|NCT00685477|Primary|Coefficient of Variation (CV) for Gallbladder Ejection Fraction (GBEF) for Each Infusion Method|The primary statistical endpoint was the CV as a measure of variability for the GBEF for each infusion method at the different intervals to determine which sincalide infusion method had the lowest variation. The CV is the SD divided by the mean and is expressed as a percentage and reflects the variability among the values. The infusion method having the lowest CV is considered best as it reflects the lowest variability of the values.|15, 30, 45, and 60 minutes post drug infusion|Some participants were excluded from analyses due to location testing procedures||percentage||95% Confidence Interval|Number
766181|NCT00685659|Primary|Percent Days Abstinent|Percent of days during the follow up that participant was abstinent from Alcohol and Cocaine|24 months (approximately study days 547 - 730)|N's represent the participants at three months for whom complete Time Line Follow Back data was available.||percentage of days||Standard Error|Mean
766182|NCT00685659|Primary|Percent Days Abstinent|Percent of days during the follow up that participant was abstinent from Alcohol and Cocaine|18 months (approximately days 366 - 546)|N's represent the participants at three months for whom complete Time Line Follow Back data was available.||percentage of days||Standard Error|Mean
766183|NCT00685659|Primary|Percent Days Abstinent|Percent of days during the follow up that participant was abstinent from Alcohol and Cocaine|12 months (approximately study days 271 - 365)|N's represent the participants at three months for whom complete Time Line Follow Back data was available.||percentage of days||Standard Error|Mean
766184|NCT00685659|Primary|Percent Days Abstinent|Percent of days during the follow up that participant was abstinent from Alcohol and Cocaine|9 months (approximately study days 181 - 270)|N's represent the participants at three months for whom complete Time Line Follow Back data was available.||percentage of days||Standard Error|Mean
766185|NCT00685659|Primary|Percent Days Abstinent|Percent of days during the follow up that participant was abstinent from Alcohol and Cocaine|6 months (approximately study days 91 - 180)|N's represent the participants at three months for whom complete Time Line Follow Back data was available.||percentage of days||Standard Error|Mean
766190|NCT00685659|Primary|Percent Days Cocaine Use|Percent of days during the follow up that there was any cocaine use|9 months (approximately study days 181 - 270)|N's represent the participants at three months for whom complete Time Line Follow Back data was available.||percentage of days||Standard Error|Mean
766193|NCT00685659|Secondary|HIV Sex Risk Score|Risk score from RAB: Risk Assessment Battery. The RAB is a 41 - item self report developed to study the transmission of HIV. The Risk Assessment Battery generates a drug-risk score and a sex-risk score. For this study, the sex-risk score was used as the outcome measure of sexual behavior that is associated with HIV transmission. The sex-risk score ranges from 0 to 18, with 0 denoting no sex-risk and 18 denoting highest sex-risk. Previous research among drug using populations have found a sex-risk score mean of 6.2.|24 months|N's represent the participants at 24 months for whom we have a completed RAB (Risk Assessment Battery).||units on a scale||Standard Deviation|Mean
766194|NCT00685659|Secondary|HIV Sex Risk Score|Risk score from RAB: Risk Assessment Battery. The RAB is a 41 - item self report developed to study the transmission of HIV. The Risk Assessment Battery generates a drug-risk score and a sex-risk score. For this study, the sex-risk score was used as the outcome measure of sexual behavior that is associated with HIV transmission. The sex-risk score ranges from 0 to 18, with 0 denoting no sex-risk and 18 denoting highest sex-risk. Previous research among drug using populations have found a sex-risk score mean of 6.2.|12 months|N's represent the participants at 12 months for whom we have a completed RAB (Risk Assessment Battery).||units on a scale||Standard Deviation|Mean
766195|NCT00685659|Secondary|Participation in Protocol|Percent available sessions completed|24 months|Participants in TAU did not receive telephone counseling so were not included in these analyses. N's for TMAC and TMAC Plus represent participants who completed orientation.||percentage of sessions||Standard Deviation|Mean
766196|NCT00685659|Primary|Net Comparisons of Savings and Spendings Across Groups From Societal Perspective|Savings minus intervention costs. Presented in 2008 dollars.|24 months|||US Dollars||Standard Deviation|Mean
766197|NCT00685659|Primary|Net Saving/Spending Comparisons Across Groups From Provider Perspective|Savings minus intervention costs. Presented in 2008 dollars.|24 months|||US Dollars||Standard Deviation|Mean
766198|NCT00685659|Primary|Comparison Across Groups in Societal Costs|Total savings/spending calculated as the monetary value of days of illegal activity, days experiencing medical problems, days experiencing psychiatric problems, and days in jail captured with the ASI. Presented in 2008 dollars.|24 months|||US Dollars||Standard Deviation|Mean
766199|NCT00685659|Primary|Cocaine Urine Toxicology|Positive cocaine test of urine|24 month follow up|The N analyzed represents the number of participants for whom we had UDS results in month 24.||proportion of participants positive|||Number
766200|NCT00685659|Primary|Cocaine Urine Toxicology|Positive cocaine test of urine|18 month follow up|The N analyzed represents the number of participants for whom we had UDS results in month 18.||proportion of participants positive|||Number
766201|NCT00685659|Primary|Cocaine Urine Toxicology|Positive cocaine test of urine|12 month follow up|The N analyzed represents the number of participants for whom we had UDS results in month 12.||proportion of participants positive|||Number
766202|NCT00685659|Primary|Cocaine Urine Toxicology|Positive cocaine test of urine|9 month follow up|The N analyzed represents the number of participants for whom we had UDS results in month 9.||proportion of participants positive|||Number
766203|NCT00685659|Primary|Cocaine Urine Toxicology|Positive cocaine test of urine|6 month follow up|The N analyzed represents the number of participants for whom we had UDS results in month 6.||proportion of participants positive|||Number
766204|NCT00685659|Primary|Cocaine Urine Toxicology|Positive cocaine test of urine|3 month follow up|The N analyzed represents the number of participants for whom we had UDS results in month 3.||proportion of participants positive|||Number
766205|NCT00685659|Primary|Abstinence|Abstinence as reported on Addiction Severity Index, Timeline Follow up, and as tested on the urine drug screen. Measure was created as such: if on ASI the participant reported no use, and on the TLFB the participant reported no use, and on the urine drug screen there was no substances detected, then the participant is considered abstinent. If there is use indicated on any one or all of those items (ASI, TLFB, UDS) then the participant is not abstinent.|24 month follow up|The N analyzed represents the number of participants we were able to reach for 24 month follow up.||participants|||Number
766206|NCT00685659|Primary|Abstinence|Abstinence as reported on Addiction Severity Index, Timeline Follow up, and as tested on the urine drug screen. Measure was created as such: if on ASI the participant reported no use, and on the TLFB the participant reported no use, and on the urine drug screen there was no substances detected, then the participant is considered abstinent. If there is use indicated on any one or all of those items (ASI, TLFB, UDS) then the participant is not abstinent.|18 month follow up|The N analyzed represents the number of participants we were able to reach for the 18 month follow up.||participants|||Number
766207|NCT00685659|Primary|Abstinence|Abstinence as reported on Addiction Severity Index, Timeline Follow up, and as tested on the urine drug screen. Measure was created as such: if on ASI the participant reported no use, and on the TLFB the participant reported no use, and on the urine drug screen there was no substances detected, then the participant is considered abstinent. If there is use indicated on any one or all of those items (ASI, TLFB, UDS) then the participant is not abstinent.|12 month follow up|The N analyzed represents the number of participants we were able to reach at the 12 month follow up for evaluation.||participants|||Number
766208|NCT00685659|Primary|Abstinence|Abstinence as reported on Addiction Severity Index, Timeline Follow up, and as tested on the urine drug screen. Measure was created as such: if on ASI the participant reported no use, and on the TLFB the participant reported no use, and on the urine drug screen there was no substances detected, then the participant is considered abstinent. If there is use indicated on any one or all of those items (ASI, TLFB, UDS) then the participant is not abstinent.|9 month follow up|The N analyzed represents the number of participants we were able to reach for the 9 month follow up evaluation.||participants|||Number
766209|NCT00685659|Primary|Abstinence|Abstinence as reported on Addiction Severity Index, Timeline Follow up, and as tested on the urine drug screen. Measure was created as such: if on ASI the participant reported no use, and on the TLFB the participant reported no use, and on the urine drug screen there was no substances detected, then the participant is considered abstinent. If there is use indicated on any one or all of those items (ASI, TLFB, UDS) then the participant is not abstinent.|6 month follow up|The N analyzed represents that number of participants we reached for 6 month follow up evaluation.||participants|||Number
766279|NCT00686257|Secondary|Early NPPV Discontinuation Rate|defined as the inability of the patient to be maintained on NPPV using the assigned mask while there was still an indication for ventilatory support|During hospitalization period (after recruitment into the study)||||||
766210|NCT00685659|Primary|Abstinence|Abstinence as reported on Addiction Severity Index, Timeline Follow up, and as tested on the urine drug screen. Measure was created as such: if on ASI the participant reported no use, and on the TLFB the participant reported no use, and on the urine drug screen there was no substances detected, then the participant is considered abstinent. If there is use indicated on any one or all of those items (ASI, TLFB, UDS) then the participant is not abstinent.|3 month follow up|The N analyzed represents that number of people we reached for three month follow up evaluation.||participants|||Number
766211|NCT00685685|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.5, 5, 5.5, 6, 7, 8, 10, 14, 18, 24, 36, and 48 hours after drug administration.|54 subjects were enrolled and 51 subjects completed the study. Lovastatin plasma concentration data for 48 subjects were used in the statistical analysis as the AUC(0-∞) was not calculated for 3 subjects. Mevacor® plasma concentration data for 50 subjects were used in the statistical analysis as the AUC(0-∞) was not calculated for 1 subject.||ng-hr/mL||Standard Deviation|Mean
766212|NCT00685685|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.5, 5, 5.5, 6, 7, 8, 10, 14, 18, 24, 36, and 48 hours after drug administration.|Plasma concentration data for 51 of the 54 enrolled subjects were used in the statistical analysis. Two subjects were withdrawn from the study for adverse reactions and one subject withdrew his consent for personal reasons.||ng-hr/mL||Standard Deviation|Mean
766213|NCT00685685|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that the drug reaches in the plasma.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.5, 5, 5.5, 6, 7, 8, 10, 14, 18, 24, 36, and 48 hours after drug administration.|Plasma concentration data for 51 of the 54 enrolled subjects were used in the statistical analysis. Two subjects were withdrawn from the study for adverse reactions and one subject withdrew his consent for personal reasons.||ng/mL||Standard Deviation|Mean
766214|NCT00685698|Secondary|Need for Surgery, Hospitalisation and Non-Study Antibiotic Therapy for Diabetic Foot Infection During Study (in PP Population)|Results in relation to the need for surgery, hospitalization, new and/or additional non-study antibiotic therapy for failure of initial oral therapy at Test of Cure.|Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination|||participants|||Number
766215|NCT00685698|Secondary|Need for Surgery, Hospitalisation and Non-Study Antibiotic Therapy for Diabetic Foot Infection During Study (in PP Population)|Results in relation to the need for surgery, hospitalization, new and/or additional non-study antibiotic therapy for failure of initial oral therapy at End of Treatment/Early Termination.|End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1)|||participants|||Number
766216|NCT00685698|Secondary|Need for Surgery, Hospitalisation and Non-Study Antibiotic Therapy for Diabetic Foot Infection During Study (in ITT Population)|Results in relation to the need for surgery, hospitalization, new and/or additional non-study antibiotic therapy for failure of initial oral therapy at Test of Cure.|Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination|Number at Test of Cure Visit, ITT population||participants|||Number
766217|NCT00685698|Secondary|Need for Surgery, Hospitalisation and Non-Study Antibiotic Therapy for Diabetic Foot Infection During Study (in ITT Population)|Results in relation to the need for surgery, hospitalization, new and/or additional non-study antibiotic therapy for failure of initial oral therapy at End of Treatment/Early Termination.|End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1)|Number at the End of Treatment/Early Termination Visit, ITT population||participants|||Number
766218|NCT00685698|Secondary|Diabetic Foot Assessment (PEDIS) Shifts From Baseline at Test of Cure in PP Population|The number of patients within each of the PEDIS grading categories (uninfected, mild, moderate and severe) at baseline and Test of Cure.|Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination|||participants|||Number
766219|NCT00685698|Secondary|Diabetic Foot Assessment (PEDIS) Shifts From Baseline at End of Treatment/Early Termination in PP Population|The number of patients within each of the PEDIS grading categories (uninfected, mild, moderate and severe) at baseline and End of Treatment/Early Termination.|End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1)|||participants|||Number
766220|NCT00685698|Secondary|Diabetic Foot Assessment (PEDIS) Shifts From Baseline at Test of Cure in ITT Population|The number of patients within each of the PEDIS grading categories (uninfected, mild, moderate and severe) at baseline and Test of Cure.|Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination|||participants|||Number
766221|NCT00685698|Secondary|Diabetic Foot Assessment (PEDIS) Shifts From Baseline at End of Treatment/Early Termination in ITT Population|The number of patients within each of the PEDIS grading categories (uninfected, mild, moderate and severe) at baseline and End of Treatment/Early Termination.|End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1)|||participants|||Number
766222|NCT00685698|Secondary|Total Wound Score (at End of Treatment/ Early Termination in PP Population)|The Diabetic Foot Infection (DFI) Wound Scores will be used to evaluate the wound assessment at baseline and Test of Cure visits. The wound composite score was based on combining the general wound parameters (signs and symptoms of infection), and wound measurements (length, width, depth). Each wound parameter was assigned a score based on severity, with higher scores defining greater severity. For wound measurements and undermining, larger measurements received higher scores. The minimum and maximum score are 3 and 49, respectively.|Visit 1 (Baseline); End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1)|||scores on a scale||Standard Deviation|Mean
766280|NCT00686257|Primary|Time Required for Mask Placement||at the initiation of NPPV||||||
766281|NCT00686257|Primary|Mask Comfort (as Determined by the Visual Analog Scores 1 Being Least, 10 Being Most)||During the first 3 hours of recruitment|By power analysis||units on a scale||Standard Error|Mean
766223|NCT00685698|Secondary|Total Wound Score (at End of Treatment/ Early Termination in ITT Population)|The Diabetic Foot Infection (DFI) Wound Scores will be used to evaluate the wound assessment at baseline and End of Treatment/ Early Termination visits. The wound composite score was based on combining the general wound parameters (signs and symptoms of infection), and wound measurements (length, width, depth). Each wound parameter was assigned a score based on severity, with higher scores defining greater severity. For wound measurements and undermining, larger measurements received higher scores. The minimum and maximum score are 3 and 49, respectively.|Visit 1 (Baseline); End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1)|||scores on a scale||Standard Deviation|Mean
766224|NCT00685698|Secondary|Total Wound Score (at Test of Cure in PP Population)|The Diabetic Foot Infection (DFI) Wound Scores will be used to evaluate the wound assessment at baseline and Test of Cure visits. The wound composite score was based on combining the general wound parameters (signs and symptoms of infection), and wound measurements (length, width, depth). Each wound parameter was assigned a score based on severity, with higher scores defining greater severity. For wound measurements and undermining, larger measurements received higher scores. The minimum and maximum score are 3 and 49, respectively.|Visit 1 (Baseline); Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination|||scores on a scale||Standard Deviation|Mean
766225|NCT00685698|Secondary|Total Wound Score (at Test of Cure in ITT Population)|The Diabetic Foot Infection (DFI) Wound Scores will be used to evaluate the wound assessment at baseline and Test of Cure visits. The wound composite score was based on combining the general wound parameters (signs and symptoms of infection), and wound measurements (length, width, depth). Each wound parameter was assigned a score based on severity, with higher scores defining greater severity. For wound measurements and undermining, larger measurements received higher scores. The minimum and maximum score are 3 and 49, respectively.|Visit 1 (Baseline); Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination|||scores on a scale||Standard Deviation|Mean
766226|NCT00685698|Secondary|Per-Pathogen Microbiological Responses|Microbiological responses were assessed on a per-pathogen basis for the most frequently isolated pathogens at baseline (i.e., present in four or more patients), including MRSA. Microbiological Responses were assessed at Test of Cure visit within each of the ITT and PP populations. Insufficient numbers prevented reporting Microbiological Success rates for Streptococcus pyogenes in the PP population.|Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination|||percentage of participants||95% Confidence Interval|Number
766227|NCT00685698|Secondary|Per-Pathogen Clinical Response (at End of Treatment/Early Termination)|Clinical responses were assessed on a per-pathogen basis for the most frequently isolated pathogens at baseline (i.e., present in four or more patients), including MRSA. Clinical Responses were assessed at at End of Treatment/Early Termination within each of the ITT and PP populations. Insufficient numbers prevented reporting Clinical Success rates for Streptococcus pyogenes in the PP population.|End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1)|||percentage of participants||95% Confidence Interval|Number
766228|NCT00685698|Secondary|Per-Pathogen Clinical Responses (at Test of Cure)|Clinical responses were assessed on a per-pathogen basis for the most frequently isolated pathogens at baseline (i.e., present in four or more patients), including MRSA. Clinical Responses were assessed at Test of Cure visit within each of the ITT and PP populations. Insufficient numbers prevented reporting Clinical Success rates for Streptococcus pyogenes in the PP population.|Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination|||percentage of participants||95% Confidence Interval|Number
766229|NCT00685698|Secondary|Clinical Success (at End of Treatment/Early Termination)|"Clinical Success
Resolution is defined as total resolution of all pretreatment clinically significant signs and symptoms of infection and no development of any systemic evidence of infection.
Improvement is defined as resolution of more than two, but not all, pretreatment clinical signs and symptoms, or partial resolution of all clinical signs and symptoms relative to the baseline assessment, with no further need for antibiotic therapy, and no need for infection-related surgical interventions."|End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1)|||percentage of participants||95% Confidence Interval|Number
766230|NCT00685698|Secondary|Clinical Success (in PP Population)|"Clinical Success
Resolution is defined as total resolution of all pretreatment clinically significant signs and symptoms of infection and no development of any systemic evidence of infection.
Improvement is defined as resolution of more than two, but not all, pretreatment clinical signs and symptoms, or partial resolution of all clinical signs and symptoms relative to the baseline assessment, with no further need for antibiotic therapy, and no need for infection-related surgical interventions."|Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination|All eligible patients who took at least one whole dose of study drug and had at least 1 gram-positive pathogen identified at the Baseline Visit (Visit 1), and adhered to the protocol without major protocol violations.||percentage of participants||95% Confidence Interval|Number
766231|NCT00685698|Secondary|Microbiological Success Rate|"Microbiological Success
Eradicated, defined as absence of the original pathogen(s) from a repeat culture of the original infection site performed at the TOC visit.
Presumed Eradicated, defined as meeting the definition for Clinical Success at the TOC visit, but tissue sample could be obtained for culture from the original infection site.
TOC=Test of Cure"|Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination|||percentage of participants||95% Confidence Interval|Number
766232|NCT00685698|Primary|Clinical Success (in ITT Population)|"Clinical Success
Resolution is defined as total resolution of all pretreatment clinically significant signs and symptoms of infection and no development of any systemic evidence of infection.
Improvement is defined as resolution of more than two, but not all, pretreatment clinical signs and symptoms, or partial resolution of all clinical signs and symptoms relative to the baseline assessment, with no further need for antibiotic therapy, and no need for infection-related surgical interventions."|Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination|All eligible patients who took at least one whole dose of study drug and had at least 1 gram-positive pathogen identified at the Baseline Visit (Visit 1).||percentage of participants||95% Confidence Interval|Number
766233|NCT00685763|Secondary|Collect and Analyze Tumor Control Measures||1 year following the completion of radiation therapy||||||
766234|NCT00685763|Primary|Cumulative Incidence of grade3+ Bowel Perforation, Grade 3+ Bleeding (Ocurring Withing 1 Years) and grade4+ Nonhematologic Acute Adverse Events (Limited to Within 90 Days of Treatment Start)||1 year following the completion of radiation therapy|||participants|||Number
766235|NCT00685802|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12, 16, 24, 36 and 48 hours after drug administration.|Pharmacokinetic analyses of cilostazol and Pletal® are based on 28 and 27 subjects, respectively. Reliable estimates could not be obtained for one subject administered Cilostazol and two subjects administered Pletal® because there was not a smooth decline in concentrations in the terminal phase of elimination.||ng-hr/mL||Standard Deviation|Mean
766236|NCT00685802|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12, 16, 24, 36 and 48 hours after drug administration.|||ng-hr/mL||Standard Deviation|Mean
766237|NCT00685802|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that cilostazol (test and reference product) reaches in the plasma.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12, 16, 24, 36 and 48 hours after drug administration.|||ng/mL||Standard Deviation|Mean
766238|NCT00685880|Primary|Number of Participants With a Decreased Pain Score >20%|Pain was measured on a 10 point visual analogue scale (VAS), with 0 meaning no pain, and 10 meaning extreme pain.|baseline, 6 month follow-up||||||
766239|NCT00685945|Other Pre-specified|Net Glucose Uptake|Individual net reuptake rates at each time point were calculated by the following formula: net uptake = (Cv-CA) x {FBF x [101-hematocrit/100]}, where Cv and CA represent the concentration of glucose in the brachial vein and artery, respectively.|At baseline and after maximum dose of bradykinin|||microgram/min/100ml||Standard Error|Mean
766240|NCT00685945|Secondary|Forearm Blood Flow (FBF)|Forearm blood flow was measured by strain gauge plethysmography|During and after each study drug administration|||ml/min/100ml||Standard Error|Mean
766241|NCT00685945|Primary|Net Tissue-type Plasminogen Activator (t-PA) Release|Individual net t-PA release at each time point were calculated by the following formula: net release = (Cv-CA) x {FBF x [101-hematocrit/100]}, where Cv and CA represent the concentration of t-PA in the brachial vein and artery, respectively.|During and after each study drug administration|Twenty four subjects were studied. One subject was excluded because of erroneous drug administration. Analysis was per protocol. Twenty-three subjects receive bradykinin then L-NMMA plus bradykinin infusions. Subjects were then randomized to either isosorbide or sildenafil. Twelve subjects received sildenafil and 11 subjects received isosorbide.||ng/min/100ml||Standard Error|Mean
766242|NCT00686036|Secondary|Serum Testosterone Levels||Change from baseline at each visit post-randomization until until week 78|Due to slow recruitment, the study was terminated early. Efficacy analysis was not performed. Therefore, zero participants were analyzed.|||||
766243|NCT00686036|Secondary|Time to PSA Progression (PSA ≥ 5ng/mL and PSA ≥ 10ng/mL)||From the time o PSA rise from the date of randomization to both PSA ≥ 5ng/mL and PSA ≥ 10ng/mL|Due to slow recruitment, the study was terminated early. Efficacy analysis was not performed. Therefore, zero participants were analyzed.|||||
766244|NCT00686036|Secondary|Percentage of Participants Not Reaching PSA ≥ 5ng/mL and/or PSA 10ng/mL (Biochemical Failure) by 78 Weeks During the Off-treatment Phase of Androgen Deprivation Therapy (ADT)||78 weeks during off-treatment phase of ADT|Due to slow recruitment, the study was terminated early. Efficacy analysis was not performed. Therefore, zero participants were analyzed.|||||
766245|NCT00686036|Primary|Number of Participants Not Reaching a PSA ≥ 5ng/mL by 52 Weeks During the Off-treatment Phase of Androgen Deprivation Therapy (ADT)||52 weeks|Due to slow recruitment, the study was terminated early. Efficacy analysis was not performed. Therefore, zero participants were analyzed.|||||
766246|NCT00686075|Secondary|Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) Through 365 Days After Randomization|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-Emergent Serious Adverse Events (TESAEs) are serious events after administration of drug which were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TESAEs (spontaneously reported events) within 365 days after randomization were reported.|Day 0 to Day 365|Safety population included all randomized participants who received study vaccine and had any safety follow-up data.||participants|||Number
766247|NCT00686075|Secondary|Number of Participants With Significant New Medical Conditions (SNMCs) Through 365 Days After Randomization|An SNMC was a newly diagnosed medical condition that was of a chronic, ongoing nature and was assessed by the investigator as medically significant. Examples of SNMCs include diabetes, asthma, autoimmune disease (for example, lupus, rheumatoid arthritis), and neurological disease (for example, epilepsy, autism).|Day 0 to Day 365|Safety population included all randomized participants who received study vaccine and had any safety follow-up data.||participants|||Number
766248|NCT00686075|Secondary|Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) Through 365 Days After Randomization|An MA-LRI was a healthcare provider-confirmed diagnosis of one or more of the following events: wheezing, pneumonia, croup (laryngotracheobronchitis), rhonchi (not cleared with cough or suctioning), rales (not cleared with cough or suctioning), bronchitis, bronchiolitis, and apnea. MA-LRIs occurring within 28 days post any dose and after 28 days post any dose were summarized separately.|Day 0 to Day 365|Safety population included all randomized participants who received study vaccine and had any safety follow-up data.||participants|||Number
766282|NCT00686335|Primary|Total Number of Nocturnal Awakenings During the Last 2 Weeks of Treatment|Variation in the total number of nocturnal awakenings during the last 2 weeks of run-in treatment with Cortancyl and the last 2 weeks of treatment with Lodotra.|4 weeks and 8 weeks|The efficacy analysis population included all 7 patients who completed both study periods without major protocol deviations.||number of nocturnal awakenings||Standard Deviation|Mean
766249|NCT00686075|Secondary|Genotypic Stability of Recovered Vaccine-Type Virus|Nasal wash samples with vaccine-type virus were evaluated for genotypic stability, defined as the presence of the entire RSV-Fusion (RSV F) insert based on the RSV F sequence results. If the insert was absent or truncated, the recovered virus was counted as genotypically unstable. Nasal wash samples were categorized as genotypically stable, genotypically unstable or undetermined genotypic stability.|Within 28 days after any dose|Shedding population included all randomized participants who received study vaccine and had valid shedding data. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||nasal wash samples|Participants||Number
766250|NCT00686075|Secondary|Percentage of Participants With a Seroresponse to Respiratory Syncytial Virus (RSV) and Human Parainfluenza Virus Type 3 (hPIV3) After Dose 3|Seroresponse was defined as a >=4-fold rise from Baseline in neutralizing antibody titer, regardless of Baseline serostatus. Respiratory Syncytial Virus (RSV) and hPIV3 antibody titers were determined by using microneutralization assay and hemagglutination inhibition assay, respectively. Clopper-pearson exact confidence interval was reported.|Day 28 after Dose 3|Immunogenicity population included all randomized participants who received study vaccine for the specified dose and had valid immunogenicity data. 'N' (number of participants analyzed) = participants evaluable for this measure; and ‘n’ = participants evaluable for specified virus type, for each group, respectively.||percentage of participants||95% Confidence Interval|Number
766251|NCT00686075|Secondary|Number of Participants Who Shed Vaccine-Type Virus|Nasal wash specimens were collected to assess vaccine virus recovery in the upper respiratory tract on 7, 12 and 28 days after each dosing.|7, 12 and 28 days after Dose 1, 2 and 3|Shedding population included all randomized participants who received study vaccine and had valid shedding data after the specified dose. ‘N’ (number of participants analyzed) = participants who were evaluable for this measure; and 'n' = participants who were evaluable for this measure at given time points for each group, respectively.||participants|||Number
766252|NCT00686075|Primary|Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 3|An MA-LRI was a healthcare provider-confirmed diagnosis of one or more of the following events: wheezing, pneumonia, croup (laryngotracheobronchitis), rhonchi (not cleared with cough or suctioning), rales (not cleared with cough or suctioning), bronchitis, bronchiolitis, and apnea.|Within 28 days after Dose 3|Dose 3 safety population included all randomized participants who received study vaccine Dose 3 same as previous doses and had safety follow-up data.||participants|||Number
766253|NCT00686075|Primary|Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 2|An MA-LRI was a healthcare provider-confirmed diagnosis of one or more of the following events: wheezing, pneumonia, croup (laryngotracheobronchitis), rhonchi (not cleared with cough or suctioning), rales (not cleared with cough or suctioning), bronchitis, bronchiolitis, and apnea.|Within 28 days after Dose 2|Dose 2 safety population included all randomized participants who received study vaccine Dose 2 same as Dose 1 and had safety follow-up data.||participants|||Number
766254|NCT00686075|Primary|Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 1|An MA-LRI was a healthcare provider-confirmed diagnosis of one or more of the following events: wheezing, pneumonia, croup (laryngotracheobronchitis), rhonchi (not cleared with cough or suctioning), rales (not cleared with cough or suctioning), bronchitis, bronchiolitis, and apnea.|Within 28 days after Dose 1|Dose 1 safety population included all randomized participants who received study vaccine Dose 1 and had safety follow-up data.||participants|||Number
766255|NCT00686075|Primary|Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 3|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-Emergent Serious Adverse Events (TESAEs) are serious events between administration of Dose 3 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TESAEs (spontaneously reported events) after Dose 3 were reported.|Within 28 days after Dose 3|Dose 3 safety population included all randomized participants who received study vaccine Dose 3 same as previous doses and had safety follow-up data.||participants|||Number
766256|NCT00686075|Primary|Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 2|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-Emergent Serious Adverse Events (TESAEs) are serious events between administration of Dose 2 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TESAEs (spontaneously reported events) after Dose 2 were reported.|Within 28 days after Dose 2|Dose 2 safety population included all randomized participants who received study vaccine Dose 2 same as Dose 1 and had safety follow-up data.||participants|||Number
766257|NCT00686075|Primary|Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 1|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-Emergent Serious Adverse Events (TESAEs) are serious events between administration of Dose 1 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TESAEs (spontaneously reported events) after Dose 1 were reported.|Within 28 days after Dose 1|Dose 1 safety population included all randomized participants who received study vaccine Dose 1 and had safety follow-up data.||participants|||Number
766283|NCT00686517|Secondary|Number of Peripheral Blood Mononuclear Cells (PBMCs)|Cellular Differentiation Cluster Antigen 8-Positive (CD8+) PBMCs were measured at randomization, Treatment Weeks 2, 4, 8, and 12.|Treatment Weeks 2, 4, 8, and 12|The association between HCV specific immune and SR to be assessed applying descriptive methods could not be evaluated as PBMC measurements were not carried out.|||||
766258|NCT00686075|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 3|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-Emergent Adverse Events (TEAEs) for Dose 3 are events between administration of Dose 3 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TEAEs (spontaneously reported events) after Dose 3 were reported.|Within 28 days after Dose 3|Dose 3 safety population included all randomized participants who received study vaccine Dose 3 same as previous doses and had safety follow-up data.||participants|||Number
766259|NCT00686075|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 2|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-Emergent Adverse Events (TEAEs) for Dose 2 are events between administration of Dose 2 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TEAEs (spontaneously reported events) after Dose 2 were reported.|Within 28 days after Dose 2|Dose 2 safety population included all randomized participants who received study vaccine Dose 2 same as Dose 1 and had safety follow-up data.||participants|||Number
766260|NCT00686075|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 1|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent adverse events (TEAEs) for Dose 1 are events between administration of Dose 1 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TEAEs (spontaneously reported events) after Dose 1 were reported.|Within 28 days after Dose 1|Dose 1 safety population included all randomized participants who received study vaccine Dose 1 and had safety follow-up data.||participants|||Number
766261|NCT00686075|Primary|Number of Participants With Solicited Symptoms After Dose 3|Solicited symptoms were predefined symptoms or events to be specifically inquired about and assessed daily during the 28-day period after vaccine administration. The solicited symptoms included fever >=100.4 degrees F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, oropharyngeal inflammation (laryngitis), and epistaxis.|Within 28 days after Dose 3|Dose 3 safety population included all randomized participants who received study vaccine Dose 3 same as previous doses and had safety follow-up data.||participants|||Number
766262|NCT00686075|Primary|Number of Participants With Solicited Symptoms After Dose 2|Solicited symptoms were predefined symptoms or events to be specifically inquired about and assessed daily during the 28-day period after vaccine administration. The solicited symptoms included fever >=100.4 degrees F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, oropharyngeal inflammation (laryngitis), and epistaxis.|Within 28 days after Dose 2|Dose 2 safety population included all randomized participants who received study vaccine Dose 2 same as Dose 1 and had safety follow-up data.||participants|||Number
766263|NCT00686075|Primary|Number of Participants With Solicited Symptoms After Dose 1|Solicited symptoms were predefined symptoms or events to be specifically inquired about and assessed daily during the 28-day period after vaccine administration. The solicited symptoms included fever greater than or equal to (>=) 100.4 degrees Fahrenheit (F), runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, oropharyngeal inflammation (laryngitis), and epistaxis.|Within 28 days after Dose 1|Dose 1 safety population included all randomized participants who received study vaccine Dose 1 and had safety follow-up data.||participants|||Number
766264|NCT00686127|Secondary|Pain Interference With Function||12 weeks||||||
766265|NCT00686127|Primary|Change in Pain Intensity on an 11-point Scale From Baseline to 12 Weeks|Patients scored their pain intensity in the breast and/or ipsilateral arm using a 0 to 10 numeric rating scale, ranging from no pain (0) to worst pain imaginable (10). The change in pain intensity was calculated from two time points as the later time point (12 weeks) minus the earlier time point (Baseline).|Baseline, 12 weeks|This study attempted to evaluate changes in average pain intensity following breast cancer surgery. However, since none of the patients in the lidocaine group completed the 12 week trial, the outcomes of this study cannot be evaluated.||units on a scale|||Number
766266|NCT00686166|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.|Only adverse events that are possibly, probably or definitely related to study regimen are reported.|Up to 4 years|Eligible patients who received any treatment and were assessed for adverse events are included in this summary.||Participants|||Number
766267|NCT00686166|Secondary|3-year Disease-free Survival|From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact.|3 years|Eligible and analyzable patients||percentage of participants||95% Confidence Interval|Number
766268|NCT00686166|Primary|Pathologic Complete Response Rate|Pathologic response is evaluated after the patient has had surgery, and is based on local pathology review of the resected surgical specimen, according to the following: a) Pathologic complete response (pCR): on review of the resected rectal specimen and accompanying lymph nodes, no cancer is recognized by the pathologist; b) Microscopic cancer: gross tumor is not seen by the pathologist but tumor remains in the microscopic analysis of any part of the entire specimen; c) no response: gross cancer is found on pathologic examination of the resected rectal cancer and draining lymph nodes.|15-20 weeks from registration|Eligible and analyzable patients with available data. It was assumed that a pathologic complete response was not achieved for patients who do not receive surgery or for whom a surgical specimen is lacking. These patients were included in the denominator.||percentage of participants||95% Confidence Interval|Number
766269|NCT00686205|Primary|PRISM HIV O Plus Test Data for Sensitivity|Final HIV status was determined according to a supplemental testing algorithm for specimens positive by the investigational assay. Supplemental testing involved HIV-1 Western blot, HIV-2 EIA, HIV-2 Western blot and HIV-1 ribonucleic acid (RNA).|12 months|1,388 specimens from individuals positive for HIV antibodies and 136 specimens positive by supplemental testing from US individuals at increased risk of HIV infection or from an HIV-2 endemic area. These 1,524 specimens were used for the sensitivity calculation.||participants|||Number
766270|NCT00686205|Primary|PRISM HIV O Plus Test Data for Specificity|Negative HIV status was determined by the results of the HIV-1/HIV-2 comparator assay and HIV-1 qualitatitve RNA.|12 months|The analysis was per the protocol.||participants|||Number
766284|NCT00686517|Secondary|Number of Participants With Rapid Virologic Response (RVR)|"Participants were considered to have RVR if serum HCV RNA level at 2 or 4
weeks of treatment was below the cut off value of the referring local
laboratory of each participating site."|Evaluated at 2 and 4 weeks of treatment|Intent-to-treat population (ITT): including all randomized participants who received at least one dose of study medication. Participants without measurements at the end of treatment or who discontinued the study for any reason before the end of the treatment were considered as non-responders.||participants|||Number
766285|NCT00686517|Secondary|Number of Participants Presenting With Alanine Transferase (ALT) Level Normalization|ALT normalization was used as a measure of biochemical response to treatment. ALT levels were assessed at each study visit by the local laboratory, and efficacy measurements at the end of treatment, at 6 and 12 months post treatment follow-up were reported.|Evaluated at end of treatment (either 12 weeks or 24 weeks, depending on randomization), at 6-month follow-up visit, or at 12-month follow-up visit.|Intent-to-treat population (ITT): including all randomized participants who received at least one dose of study medication. Participants without measurements at the end of treatment or who discontinued the study for any reason before the end of the treatment were considered as non-responders.||participants|||Number
766286|NCT00686517|Secondary|Virologic Response at 12 Months Post-treatment Follow-up (Long-term Response, [LTR]).|LTR was obtained if serum HCV RNA level at the end of 12-month follow-up was <15 IU/mL.|At 12 months post-treatment (treatment period either 12 weeks or 24 weeks depending on randomization).|Intent-to-treat population (ITT): including all randomized participants who received at least one dose of study medication. Participants without measurements at the end of treatment or who discontinued the study for any reason before the end of the treatment were considered as non-responders.||participants|||Number
766287|NCT00686517|Secondary|Virologic Response at the End of Treatment Follow-up (ETR)|"ETR was achieved if serum HCV RNA level at the end of 12 or 24 weeks
treatment (depending on treatment arm) was <15 IU/mL."|At the end of treatment (either 12 weeks or 24 weeks depending on randomization).|Intent-to-treat population (ITT): including all randomized participants who received at least one dose of study medication. Participants without measurements at the end of treatment or who discontinued the study for any reason before the end of the treatment were considered as non-responders.||participants|||Number
766288|NCT00686517|Primary|Number of Participants With Sustained Response (SR) at the End of the 6-month Follow-up Period|SR was defined as serum Hepatitis C Virus (HCV RNA) level at the end of 6-month follow-up below 15 IU/mL.|Evaluated at the end of 6 months|Intent-to-treat population (ITT): including all randomized participants who received at least one dose of study medication. Participants without measurements at the end of treatment or who discontinued the study for any reason before the end of the treatment were considered as non-responders.||participants|||Number
766289|NCT00686543|Primary|Participants With a Mean POS Plasma Concentration ≥/<350 ng/mL on Day 8 and ≥/<700 ng/mL on Day 15|Individual mean concentrations were calculated as the average of observed concentrations at 0 hour (before the morning dose) and 5 hours after the morning dose.|Predose (0 hour) and 5 hours postdose on Days 8 and 15|Analysis of the primary outcome was done on the Balanced Data Set, defined as all participants with no missing pharmacokinetic data for Days 3, 8, and 15 (n=49). From Days 1 to 8, these 49 participants received 200 mg TID. From Days 9 to 15, these 49 participants were randomized to either 200 mg TID (n=19), 400 mg BID (n=14), or 400 mg TID (n=16).||Participants|||Number
766290|NCT00686543|Primary|Participants With a Mean POS Plasma Concentration ≥/<250 ng/mL on Day 8 and ≥/<500 ng/mL on Day 15|Individual mean concentrations calculated as the average of observed concentrations at 0 hour (before the morning dose) and 5 hours after the morning dose.|Predose (0 hour) and 5 hours postdose on Days 8 and 15|Analysis of the primary outcome was done on the Balanced Data Set, defined as all participants with no missing pharmacokinetic data for Days 3, 8, and 15 (n=49). From Days 1 to 8, these 49 participants received 200 mg TID. From Days 9 to 15, these 49 participants were randomized to either 200 mg TID (n=19), 400 mg BID (n=14), or 400 mg TID (n=16).||Participants|||Number
766291|NCT00686543|Primary|Participants With a Mean POS Plasma Concentration ≥/<350 ng/mL on Day 3 and ≥/<700 ng/mL on Day 8|Individual mean concentrations were calculated as the average of observed concentrations at 0 hour (before the morning dose) and 5 hours after the morning dose.|Predose (0 hour) and 5 hours postdose on Days 3 and 8|Analysis of the primary outcome was done on the Balanced Data Set, defined as all participants with no missing pharmacokinetic data for Days 3, 8, and 15 (n=49). From Days 1 to 8, these 49 participants received 200 mg TID. From Days 9 to 15, these 49 participants were randomized to either 200 mg TID (n=19), 400 mg BID (n=14), or 400 mg TID (n=16).||Participants|||Number
766292|NCT00686543|Primary|Participants With a Mean POS Plasma Concentration ≥/<250 ng/mL on Day 3 and ≥/<500 ng/mL on Day 8|Individual mean concentrations were calculated as the average of observed concentrations at 0 hour (before the morning dose) and 5 hours after the morning dose.|Predose (0 hour) and 5 hours postdose on Days 3 and 8|Analysis of the primary outcome was done on the Balanced Data Set, defined as all participants with no missing pharmacokinetic data for Days 3, 8, and 15 (n=49). From Days 1 to 8, these 49 participants received 200 mg TID. From Days 9 to 15, these 49 participants were randomized to either 200 mg TID (n=19), 400 mg BID (n=14), or 400 mg TID (n=16).||Participants|||Number
766293|NCT00686543|Primary|Mean POS Plasma Concentrations on Days 8 and 15 Stratified by Randomized Dosing Regimen|Individual mean concentrations were calculated as the average of observed concentrations at 0 hour (before the morning dose) and 5 hours after the morning dose.|Predose (0 hour) and 5 hours postdose on Days 8 and 15|Analysis of the primary outcome was done on the Balanced Data Set, defined as all participants with no missing pharmacokinetic data for Days 3, 8, and 15 (n=49). From Days 1 to 8, these 49 participants received 200 mg TID. From Days 9 to 15, these 49 participants were randomized to either 200 mg TID (n=19), 400 mg BID (n=14), or 400 mg TID (n=16).||ng/mL||90% Confidence Interval|Mean
766294|NCT00686543|Primary|Mean POS Plasma Concentrations on Days 2, 3, and 8.|Individual mean concentrations were calculated as the average of observed concentrations at 0 hour (before the morning dose) and 5 hours after the morning dose.|Predose (0 hour) and 5 hours postdose on Days 2, 3, and 8|Analysis of the primary outcome was done on the Balanced Data Set, defined as all participants with no missing pharmacokinetic data for Days 3, 8, and 15 (n=49). From Days 1 to 8, these 49 participants received 200 mg TID. From Days 9 to 15, these 49 participants were randomized to either 200 mg TID (n=19), 400 mg BID (n=14), or 400 mg TID (n=16).||ng/mL||90% Confidence Interval|Mean
766295|NCT00686595|Secondary|Percent Reduction in SKINDEX-29 Scores at Week 24|The SKINDEX-29 measures the quality of life in dermatological participants, who complete a questionnaire assessing 3 scales - burden of symptoms, social functioning and emotional state. Participants answered 29 questions referring to the previous 4-week period, on a 5-point scale from “never” (=0) to “all the time” (=4). The score for each scale ranges from 0 to 100 and higher scores reflect a worse quality of life. The percent reduction in SKINDEX-29 scores at Week 24 compared to baseline is reported.|Baseline and Week 24|Participants from the ITT population for whom the SKINDEX-29 assessments were available.||Percent reduction||Standard Deviation|Mean
766296|NCT00686595|Secondary|Percent Reduction in Skin Index Questionnaire (SKINDEX-29) Score at Week 18|The SKINDEX-29 measures the quality of life in dermatological participants, who complete a questionnaire assessing 3 scales - burden of symptoms, social functioning and emotional state. Participants answered 29 questions referring to the previous 4-week period, on a 5-point scale from “never” (=0) to “all the time” (=4). The score for each scale ranges from 0 to 100 and higher scores reflect a worse quality of life. The percent reduction in SKINDEX-29 scores at Week 18 compared to baseline is reported.|Baseline and Week 18|Participants from the ITT population for whom the SKINDEX-29 assessments were available.||Percent reduction||Standard Deviation|Mean
766297|NCT00686595|Secondary|Percent Reduction in DLQI Total Score at Week 24|DLQI total score comprises 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. DLQI total scores range from 0 to 30, with 0 corresponding to the best quality of life and 30 to the worst. The percent reduction in DLQI score at Week 24 compared to baseline is reported.|Baseline and Week 24|Participants from the ITT population for whom the DLQI assessment was available.||Percent reduction||Standard Deviation|Mean
766298|NCT00686595|Secondary|Percent Reduction in Dermatology Life Quality Index (DLQI) Total Score at Week 18|DLQI total score comprises 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. DLQI total scores range from 0 to 30, with 0 corresponding to the best quality of life and 30 to the worst. The percent reduction in DLQI score at Week 18 compared to baseline is reported.|Baseline and Week 18|Participants from the ITT population for whom the DLQI assessment was available.||Percent reduction||Standard Deviation|Mean
766299|NCT00686595|Secondary|Percent Reduction in VAS Referred Itch at Week 24|VAS was used to measure itch. Participants reported itch using VAS - a line ranging from 0 cm to 10 cm, measured by the investigator. 0 cm referred to absence of itch and 10 cm referred to severe itching. The percent reduction in VAS at Week 24 compared to baseline is reported.|Baseline and Week 24|Participants from the ITT population for whom the VAS assessment was available.||Percent reduction||Standard Deviation|Mean
766300|NCT00686595|Secondary|Percent Reduction in Visual Analogue Scale (VAS) Referred Itch at Week 18|VAS was used to measure itch. Participants reported itch using VAS - a line ranging from 0 cm to 10 cm, measured by the investigator. 0 cm referred to absence of itch and 10 cm referred to severe itching. The percent reduction in VAS at Week 18 compared to baseline is reported.|Baseline and Week 18|Participants from the ITT population for whom the VAS assessment was available.||Percent reduction||Standard Deviation|Mean
766301|NCT00686595|Secondary|Percent Reduction in Affected BSA at Week 24|The BSA is the physician's evaluation for the extent of disease. The entire body area is divided into 4 districts: head, upper limbs, trunk and lower limbs to which corresponds the 10%, 20%, 30% and 40% of the entire body surface respectively. The investigator assesses the percentage of the participant’s body surface area affected by psoriasis in each district. The final affected BSA value is the sum of the percentage of each district. The percent reduction in affected BSA at Week 24 compared to baseline is reported.|Baseline and Week 24|Participants from the ITT population for whom the BSA assessment was available.||Percent reduction||Standard Deviation|Mean
766302|NCT00686595|Secondary|Percent Reduction in Affected Body Surface Area (BSA) at Week 18|The BSA is the physician's evaluation for the extent of disease. The entire body area is divided into 4 districts: head, upper limbs, trunk and lower limbs to which corresponds the 10%, 20%, 30% and 40% of the entire body surface respectively. The investigator assesses the percentage of the participant’s body surface area affected by psoriasis in each district. The final affected BSA value is the sum of the percentage of each district. The percent reduction in affected BSA at Week 18 compared to baseline is reported.|Baseline and Week 18|Participants from the ITT population for whom the BSA assessment was available.||Percent reduction||Standard Deviation|Mean
766303|NCT00686595|Secondary|Percent Reduction in SAPASI at Week 24|SAPASI is the participant's measurement of severity of psoriasis. The participant estimates the area of psoriatic involvement for each body district (head, upper limbs, trunk and lower limbs) and scores it from 0 (no involvement)-6 (90-100% involvement); and the extent of psoriasis from 0 (no involvement) to 4 (very marked) for each - erythema, desquamation and induration of the plaques. The final score computed by the investigator ranged from 0-72. The percent reduction in SAPASI at Week 24 compared to baseline is reported.|Baseline and Week 24|Participants from the ITT population for whom the SAPASI assessment was available.||Percent reduction||Standard Deviation|Mean
766304|NCT00686595|Secondary|Percent Reduction in Self-Administered Psoriasis Area Severity Index (SAPASI) at Week 18|SAPASI is the participant's measurement of severity of psoriasis. The participant estimates the area of psoriatic involvement for each body district (head, upper limbs, trunk and lower limbs) and scores it from 0 (no involvement)-6 (90-100% involvement); and the extent of psoriasis from 0 (no involvement) to 4 (very marked) for each - erythema, desquamation and induration of the plaques. The final score computed by the investigator ranged from 0-72. The percent reduction in SAPASI at Week 18 compared to baseline is reported.|Baseline and Week 18|Participants from the ITT population for whom the SAPASI assessment was available.||Percent reduction||Standard Deviation|Mean
766305|NCT00686595|Secondary|PASI 100 Response Rate at Week 24|PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 100 response rate at Week 24 is measured as the percentage of participants who achieved 100% improvement from baseline PASI at Week 24.|24 weeks|Participants from the ITT population for whom the PASI assessment was available.||Percentage of participants|||Number
766306|NCT00686595|Secondary|PASI 100 Response Rate at Week 18|PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 100 response rate at Week 18 is measured as the percentage of participants who achieved 100% improvement from baseline PASI at Week 18.|Baseline and 18 weeks|Participants from the ITT population for whom the PASI assessment was available.||Percentage of participants|||Number
766307|NCT00686595|Secondary|PASI 100 Response Rate at Week 10|PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 100 response rate at Week 10 is measured as the percentage of participants who achieved 100% improvement from baseline PASI at Week 10.|Baseline and 10 weeks|Participants from the ITT population for whom the PASI assessment was available.||Percentage of participants|||Number
766308|NCT00686595|Secondary|PASI 90 Response Rate at Week 24|PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 90 response rate at Week 24 is measured as the percentage of participants who achieved at least 90% improvement from baseline PASI at Week 24.in PASI at Week 24|Baseline and 24 weeks|Participants from the ITT population for whom the PASI assessment was available.||Percentage of participants|||Number
766309|NCT00686595|Secondary|PASI 90 Response Rate at Week 18|PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 90 response rate at Week 18 is measured as the percentage of participants who achieved at least 90% improvement from baseline PASI at Week 18.|Baseline and 18 weeks|Participants from the ITT population for whom the PASI assessment was available.||Percentage of participants|||Number
766310|NCT00686595|Secondary|PASI 90 Response Rate at Week 10|PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 90 response rate at Week 10 is measured as the percentage of participants who achieved at least 90% improvement from baseline PASI at Week 10.|Baseline and 10 weeks|Participants from the ITT population for whom the PASI assessment was available.||Percentage of participants|||Number
766311|NCT00686595|Secondary|PASI 50 Response Rate at Week 24|PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 50 response rate at Week 24 is measured as the percentage of participants who achieved at least 50% improvement from baseline PASI at Week 24.|Baseline and 24 weeks|Participants from the ITT population for whom the PASI assessment was available.||Percentage of participants|||Number
766312|NCT00686595|Secondary|PASI 50 Response Rate at Week 18|PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 50 response rate at Week 18 is measured as the percentage of participants who achieved at least 50% improvement from baseline PASI at Week 18.|Baseline and 18 weeks|Participants from the ITT population for whom the PASI assessment was available.||Percentage of participants|||Number
766313|NCT00686595|Secondary|PASI 50 Response Rate at Week 10|PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 50 response rate at Week 10 is measured as the percentage of participants who achieved at least 50% improvement from baseline PASI at Week 10.|Baseline and 10 weeks|Participants from the ITT population for whom the PASI assessment was available.||Percentage of participants|||Number
766314|NCT00686595|Secondary|PASI 75 Response Rate at Week 24|PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 75 response rate at Week 24 is measured as the percentage of participants who achieved at least 75% improvement from baseline PASI at Week 24.|Baseline and 24 weeks|Participants from the ITT population for whom the PASI assessment was available.||Percentage of participants|||Number
766315|NCT00686595|Secondary|PASI 75 Response Rate at Week 18|PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 75 response rate at Week 18 is measured as the percentage of participants who achieved at least 75% improvement from baseline PASI at Week 18.|Baseline and 18 weeks|Participants from the ITT population for whom the PASI assessment was available.||Percent of participants|||Number
766355|NCT00686777|Primary|Number of Participants Discontinuing Treatment|Prespecified adverse event discontinuance criteria included neutrophil count <500 /mm3, platelet count <50,000/mm3, and hemoglobin <8.5 g/dL.|From time of first treatment to Week 48|||participants|||Number
766316|NCT00686595|Primary|Psoriasis Area and Severity Index (PASI) 75 Response Rate at Week 10|PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 75 response rate at Week 10 is measured as the percentage of participants who achieved at least 75% improvement from baseline PASI at Week 10.|Baseline and 10 weeks|Participants from the intent-to-treat (ITT) population for whom the PASI assessment was available.||Percentage of participants|||Number
766317|NCT00686634|Secondary|Number of Adverse Events||1 year|||Adverse event|||Number
766318|NCT00686634|Secondary|Number of Subjects Maintaining Hemoglobin A1c 7.5% or Less by 1 Year||1 year|||participants|||Number
766319|NCT00686634|Secondary|Number of Subjects With Hemoglobin A1c 7.5% or Less at 4 Months||4 months|||participants|||Number
766320|NCT00686634|Primary|Hemoglobin A1c (HbA1c) Change From Baseline||Baseline, 4 months|Last Observation Carried Forward for subjects with paradoxical worsening of control (switched to alternate treatment before 4 months)||percentage||Standard Deviation|Mean
766321|NCT00686647|Secondary|Major Adverse Cardiac Events|cardiac death, myocardial infarction, or target lesion revascularization|9 months|||percentage of participants|||Number
766322|NCT00686647|Secondary|Major Adverse Cardiovascular Events|cardiac death, myocardial infarction, or target lesion revascularization|30 days|intention to treat||percentage of particpants|||Number
766323|NCT00686647|Primary|Procedural Success|Defined as less than or equal to 30% diameter stenosis in the main branch and less than or equal to 70% diameter stenosis in the side branch at the conclusion of the procedure (including adjunctive stenting) in the absence of in-hospital major adverse cardiac events (MACE) [cardiac death, myocardial infarction (MI), or target lesion revascularization (TLR]|1 day|intention to treat||percentage of participants|||Number
766324|NCT00686686|Secondary|Dermatology Life Quality Index (DLQI)|"The DLQI is a dermatology-specific quality of life (QOL) instrument designed to assess the impact of the disease on a subject's QOL. It is a 10-item questionnaire that can be used to assess 6 different aspects that may affect QOL: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. The DLQI was completed by the subject prior to the PPPASI and PGA evaluations.
The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired."|Baseline and Week 12|One of the 17 participants in the Per Protocol population did not perform the week 12 visit, therefore n=16.||scores on a scale||Standard Deviation|Mean
766325|NCT00686686|Secondary|Number of Participants Who Respond to the Fourth Infusion.|>=25% reduction in PPPASI score would be considered a response.|Week 12 and Week 18|Only three participants received a fourth infusion but according to the protocol they were not suppose to receive it at that time because their improvement in PPPASI score on Week 8 was less than 75%. Therefore, because no participants qualified to be analyzed for this endpoint, no data are given.|||||
766326|NCT00686686|Secondary|Number of Participants Achieving Clear to Minimal PGA Score at Weeks 12 and 18.|"The Physician Static Global Assessment (PGA) documents the physician's assessment of the subject's psoriasis status according to the following categories: induration, scaling, and erythema. Each category is rated from 0 to 5, where 0 represents no evidence of induration/scaling/erythema (clear), 1 represents minimal induration/scaling/erythema, and 5 represents the most severe induration/scaling/erythema."|Weeks 12 and 18|One of the 17 participants in the Per Protocol population did not perform the week 12 visit, therefore n=16 for the Week 12 observations (but n=17 for the Week 18 observations).||participants|||Number
766327|NCT00686686|Secondary|Number of Participants Who Achieve a Moderate Response.|Moderate response is defined as a 50% to 75% reduction in PPPASI score from baseline.|Baseline and Week 8|It was decided that this analysis will not be done.|||||
766328|NCT00686686|Primary|Number of Participants Who Achieve at Least 75% Improvement in Palmoplantar Psoriasis Activity Severity Index (PPPASI) After 3 Infusions.|"The PPPASI score is an overall score of disease signs: extent, scales, erythema, erosions (fissures), induration and pustules. Extent is rated on a scale range from 0-6; all other signs are rated on a scale range from 0 to 4 in a target palm and/or sole. Total score range:0-26. A reduction in score is considered an improvement."|Baseline and Week 8|Per Protocol population included the 17 subjects who completed the trial.||participants|||Number
766329|NCT00686699|Secondary|Mean ESRS Part IV Subscores: Dyskinesia Within the 6-hour Evaluation on Day 14 of Each Treatment Period|The ESRS consists of 4 subscales: 1) a questionnaire of EPS and DIMD over the previous 7 days (7 items scored as 0=Absent to 3=Severe; score range: 0-21), 2) an examination of Parkinsonism and akathisia (17 items scored as 0=None to 6=Severe; score range: 0-102), 3) an examination of dystonia (10 items scored as 0=Absent to 6=Most Severe; score range 0-60) and 4) an examination of dyskinesia (7 items scored as 0=None to 6=Severe; score range: 0-42). A lower subscale score reflects a better outcome. The mean subscores at Hours 1, 2, 3, 4, 5 and 6 on Day 14 were analyzed.|1, 2, 3, 4, 5, and 6 hours post-dose on Day 14|Consisted of all participants who had a Baseline value and at least one post-Baseline value at each time point for Day 14 ESRS scores from both treatment periods. Therefore Baseline includes only participants who had corresponding data on Day 14.||Score on a scale||Standard Deviation|Mean
766330|NCT00686699|Secondary|Lowest ESRS Part IV Subscore: Dyskinesia Within the 6-hour Evaluation on Day 14 of Each Treatment Period|The ESRS consists of 4 subscales: 1) a questionnaire of EPS and DIMD over the previous 7 days (7 items scored as 0=Absent to 3=Severe; score range: 0-21), 2) an examination of Parkinsonism and akathisia (17 items scored as 0=None to 6=Severe; score range: 0-102), 3) an examination of dystonia (10 items scored as 0=Absent to 6=Most Severe; score range 0-60) and 4) an examination of dyskinesia (7 items scored as 0=None to 6=Severe; score range: 0-42). A lower subscale score reflects a better outcome. The lowest subscale score on Day 14 was analyzed.|Up to 6 hours post-dose on Day 14|Consisted of all participants who received both treatments & had Day 14 ESRS scores from both treatment periods.||Score on a scale||Standard Deviation|Mean
766356|NCT00686777|Secondary|Percentage of Participants With HCV-RNA Negativity at 24 Weeks of Treatment and at EOT|HCV-RNA negativity was assessed by an RT-PCR method, where a negative response was defined by a negative qualitative HCV-RNA result.|Measured at 24 weeks of treatment and at EOT (Treatment week 48)|All treated Participants||percentage of participants|||Number
766331|NCT00686699|Secondary|Mean ESRS Part III Subscores: Dystonia Within the 6-hour Evaluation on Day 14 of Each Treatment Period|The ESRS consists of 4 subscales: 1) a questionnaire of EPS and DIMD over the previous 7 days (7 items scored as 0=Absent to 3=Severe; score range: 0-21), 2) an examination of Parkinsonism and akathisia (17 items scored as 0=None to 6=Severe; score range: 0-102), 3) an examination of dystonia (10 items scored as 0=Absent to 6=Most Severe; score range 0-60) and 4) an examination of dyskinesia (7 items scored as 0=None to 6=Severe; score range: 0-42). A lower subscale score reflects a better outcome. The mean subscores at Hours 1, 2, 3, 4, 5 and 6 on Day 14 were analyzed.|1, 2, 3, 4, 5, and 6 hours post-dose on Day 14|Consisted of all participants who had a Baseline value and at least one post-Baseline value at each time point for Day 14 ESRS scores from both treatment periods. Therefore Baseline includes only participants who had corresponding data on Day 14.||Score on a scale||Standard Deviation|Mean
766332|NCT00686699|Secondary|Lowest ESRS Part III Subscore: Dystonia Within the 6-hour Evaluation on Day 14 of Each Treatment Period|The ESRS consists of 4 subscales: 1) a questionnaire of EPS and DIMD over the previous 7 days (7 items scored as 0=Absent to 3=Severe; score range: 0-21), 2) an examination of Parkinsonism and akathisia (17 items scored as 0=None to 6=Severe; score range: 0-102), 3) an examination of dystonia (10 items scored as 0=Absent to 6=Most Severe; score range 0-60) and 4) an examination of dyskinesia (7 items scored as 0=None to 6=Severe; score range: 0-42). A lower subscale score reflects a better outcome. The lowest subscale score on Day 14 was analyzed.|Up to 6 hours post-dose on Day 14|Consisted of all participants who received both treatments & had Day 14 ESRS scores from both treatment periods.||Score on a scale||Standard Deviation|Mean
766333|NCT00686699|Secondary|Mean ESRS Part II Subscores: Parkinsonism and Akathisia Within the 6-hour Evaluation on Day 14 of Each Treatment Period|The ESRS consists of 4 subscales: 1) a questionnaire of EPS and DIMD over the previous 7 days (7 items scored as 0=Absent to 3=Severe; score range: 0-21), 2) an examination of Parkinsonism and akathisia (17 items scored as 0=None to 6=Severe; score range: 0-102), 3) an examination of dystonia (10 items scored as 0=Absent to 6=Most Severe; score range 0-60) and 4) an examination of dyskinesia (7 items scored as 0=None to 6=Severe; score range: 0-42). A lower subscale score reflects a better outcome. The mean subscores at Hours 1, 2, 3, 4, 5 and 6 on Day 14 were analyzed.|1, 2, 3, 4, 5, and 6 hours post-dose on Day 14|Consisted of all participants who had a Baseline value and at least one post-Baseline value at each time point for Day 14 ESRS scores from both treatment periods. Therefore Baseline includes only participants who had corresponding data on Day 14.||Score on a scale||Standard Deviation|Mean
766334|NCT00686699|Secondary|Lowest ESRS Part II Subscore: Parkinsonism and Akathisia Within the 6-hour Evaluation on Day 14 of Each Treatment Period|The ESRS consists of 4 subscales: 1) a questionnaire of EPS and DIMD over the previous 7 days (7 items scored as 0=Absent to 3=Severe; score range: 0-21), 2) an examination of Parkinsonism and akathisia (17 items scored as 0=None to 6=Severe; score range: 0-102), 3) an examination of dystonia (10 items scored as 0=Absent to 6=Most Severe; score range 0-60) and 4) an examination of dyskinesia (7 items scored as 0=None to 6=Severe; score range: 0-42). A lower subscale score reflects a better outcome. The lowest subscale score on Day 14 was analyzed.|Up to 6 hours post-dose on Day 14|Consisted of all participants who received both treatments & had Day 14 ESRS scores from both treatment periods.||Score on a scale||Standard Deviation|Mean
766335|NCT00686699|Secondary|Mean ESRS Part I Subscore: EPS and DIMD Within the 6-hour Evaluation on Day 14 of Each Treatment Period|The ESRS consists of 4 subscales: 1) a questionnaire of EPS and DIMD over the previous 7 days (7 items scored as 0=Absent to 3=Severe; score range: 0-21), 2) an examination of Parkinsonism and akathisia (17 items scored as 0=None to 6=Severe; score range: 0-102), 3) an examination of dystonia (10 items scored as 0=Absent to 6=Most Severe; score range 0-60) and 4) an examination of dyskinesia (7 items scored as 0=None to 6=Severe; score range: 0-42). A lower subscale score reflects a better outcome. The mean subscores at Hours 1, 2, 3, 4, 5 and 6 on Day 14 were analyzed.|1, 2, 3, 4, 5, and 6 hours post-dose on Day 14|Consisted of all participants who had a Baseline value and at least one post-Baseline value at each time point for Day 14 ESRS scores from both treatment periods. Therefore Baseline includes only participants who had corresponding data on Day 14.||Score on a scale||Standard Deviation|Mean
766336|NCT00686699|Secondary|Lowest ESRS Part I Subscore: EPS and DIMD Within the 6-hour Evaluation on Day 14 of Each Treatment Period|The ESRS consists of 4 subscales: 1) a questionnaire of EPS and DIMD over the previous 7 days (7 items scored as 0=Absent to 3=Severe; score range: 0-21), 2) an examination of Parkinsonism and akathisia (17 items scored as 0=None to 6=Severe; score range: 0-102), 3) an examination of dystonia (10 items scored as 0=Absent to 6=Most Severe; score range 0-60) and 4) an examination of dyskinesia (7 items scored as 0=None to 6=Severe; score range: 0-42). A lower subscale score reflects a better outcome. The lowest subscale score on Day 14 was analyzed.|Up to 6 hours post-dose on Day 14|Consisted of all participants who received both treatments & had Day 14 ESRS scores from both treatment periods.||Score on a scale||Standard Deviation|Mean
766337|NCT00686699|Secondary|Mean ESRS Total Scores Within the 6-hour Evaluation on Day 14 of Each Treatment Period|The ESRS total score consists of 4 subscales: 1) a questionnaire of EPS and DIMD over the previous 7 days (7 items scored as 0=Absent to 3=Severe; score range: 0-21), 2) an examination of Parkinsonism and akathisia (17 items scored as 0=None to 6=Severe; score range: 0-102), 3) an examination of dystonia (10 items scored as 0=Absent to 6=Most Severe; score range 0-60) and 4) an examination of dyskinesia (7 items scored as 0=None to 6=Severe; score range: 0-42). The ESRS total score could range from 0 to 225, with a lower score reflecting a better outcome. The mean ESRS total scores at Hours 1, 2, 3, 4, 5, and 6 on Day 14 were analyzed.|1, 2, 3, 4, 5, and 6 hours post-dose on Day 14|Consisted of all participants who had a Baseline value and at least one post-Baseline value at each time point for Day 14 ESRS scores from both treatment periods. Therefore Baseline includes only participants who had corresponding data on Day 14.||Score on a scale||Standard Deviation|Mean
766357|NCT00686777|Primary|Percentage of Participants With Sustained Virologic Response (SVR) at 24 Weeks After the End of Treatment (EOT) or Discontinuation|"SVR was defined as a viral response which was sustained at 24 weeks after the end of treatment as measured by Hepatitis C Virus Ribonucleic Acid (HCV-RNA) negativity.
HCV-RNA negativity was assessed by an reverse transcriptase polymerase chain reaction (RT-PCR) method, where a negative response was defined by a negative qualitative HCV-RNA result."|Measured at 24 weeks after the end of treatment (at the end of follow-up)|All treated Participants||percentage of participants|||Number
770372|NCT00711009|Secondary|Mean Change From Baseline in Lactate Dehydrogenase (Units/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||units/liter||Standard Deviation|Mean
766338|NCT00686699|Primary|Lowest Extrapyramidal Symptom Rating Score (ESRS) Total Score Within the 6-hour Evaluation on Day 14 of Each Treatment Period|The ESRS total score consists of 4 subscales: 1) a questionnaire of extrapyramidal symptoms (EPS) and drug-induced movement disorders (DIMD) over the previous 7 days (7 items scored as 0=Absent to 3=Severe; score range: 0-21), 2) an examination of Parkinsonism and akathisia (17 items scored as 0=None to 6=Severe; score range: 0-102), 3) an examination of dystonia (10 items scored as 0=Absent to 6=Most Severe; score range 0-60) and 4) an examination of dyskinesia (7 items scored as 0=None to 6=Severe; score range: 0-42). The ESRS total score could range from 0 to 225, with a lower score reflecting a better outcome. The lowest ESRS total score for each participant within the 6-hour range on Day 14 was analyzed.|Up to 6 hours post-dose on Day 14|Consisted of all participants who received both treatments & had Day 14 ESRS scores from both treatment periods.||Score on a scale||Standard Deviation|Mean
766339|NCT00686712|Secondary|Any Adverse Event Other Than Hypoglycemia|Any reported adverse event that is not hypoglycemia|6 months|Enrolled subjects||Events|||Number
766340|NCT00686712|Secondary|Total Daily Insulin Dose|Total daily number of units of insulin used|6 months|Enrolled subjects||Units of insulin per day||Standard Deviation|Mean
766341|NCT00686712|Secondary|Body Mass Index Change From Baseline|Change in body mass index from baseline BMI measurement|6 months|Enrolled subjects||kg per square meter||Standard Deviation|Mean
766342|NCT00686712|Secondary|Frequency of Severe Hypoglycemic Reactions|Frequency of severe hypoglycemic reactions, defined as those requiring the assistance of another person|6 months|Enrolled subjects||Severe hypoglycemic events|||Number
766343|NCT00686712|Secondary|Frequency of Total Hypoglycemic Reactions|Frequency of hypoglycemic reactions without regard to time of occurrence|6 months|Enrolled subjects||Hypoglycemic events per patient||Standard Deviation|Mean
766344|NCT00686712|Secondary|Frequency of Glucose Readings < 130 mg/dL|Frequency of glucose readings below the recommended pre-meal glucose target of 130 mg/dL|6 months|Enrolled subjects||percentage of readings||Standard Deviation|Mean
766345|NCT00686712|Primary|Hemoglobin A1c Change From Baseline||Baseline to 6 months|ITT (LOCF)||Percent||Standard Deviation|Mean
766358|NCT00686790|Secondary|Number of Participants With a Liver Histology Response|"The liver histology response was defined as at least a 2 point decrease in the necrosis inflammation score (a sum of periportal necrosis [0-10], lobular inflammation [0-4], portal inflammation [0-4], with the total score of 18 representing the worst outcome) and no increase or regression of fibrosis (scored [0-4]) in the pre- and post-treatment liver biopsies.
The efficacy of treatment based on histological response was assessed by the investigator as complete response, partial response, minimal response, progressive disease, and not assessable at EOT."|Baseline and 52 week (EOT)|The population analyzed excludes participants that were not administered any study medication and had protocol violations. 2 participants with adverse events (AE) that had protocol violations have been included in the analysis.||Participants|||Number
766359|NCT00686790|Primary|Number of Participants With a Combined Response|"The combined response was defined as an ALT level below the upper
reference range and a negative HDV-RNA test. The normal reference range for ALT is 5-55 U/L."|52 weeks (EOT), 104 weeks (EOF)|"The population analyzed excluded participants that were not administered study medication, had protocol violations and those for whom ALT values were not available.
2 participants with adverse events (AE) that had protocol violations have been included in the analysis."||Participants|||Number
766360|NCT00686790|Primary|Number of Participants With a Biochemical Response|A participant was defined as a responder if his alanine aminotransferase (ALT) level after 52 weeks, i.e. at EOT, was below the upper reference range as specified by Bioclinica. The normal reference range for ALT is 5-55 U/L.|52 weeks (EOT), 104 weeks (EOF)|"The population analyzed excluded participants that were not administered study medication, had protocol violations and those for whom ALT values were not available.
2 participants with adverse events (AE) that had protocol violations have been included in the analysis."||Participants|||Number
766361|NCT00686790|Secondary|Number of Participants With Hepatitis B Virus (HBV) Replication Response (HBV Response)|Serum samples collected from the participants were tested by PCR to detect HBV-DNA. HBV response was defined as the absence of HBV-deoxyribonucleic acid (HBV-DNA) in serum.|52 week (EOT)|The population analyzed excludes participants that were not administered any study medication and had protocol violations. 2 participants with adverse events (AE) that had protocol violations have been included in the analysis.||Participants|||Number
766362|NCT00686790|Primary|Number of Participants With a Virological Response|For virological response, a participant was defined as a responder if his/her serum sample tested negative for Hepatitis D Virus - ribonucleic acid (HDV-RNA) by polymerase chain reaction (PCR) at end of treatment (EOT).|52 weeks (end of treatment [EOT]), 104 weeks (end of follow-up [EOF]) following treatment initiation|The population analyzed excludes participants that were not administered any study medication and had protocol violations. 2 participants with adverse events (AE) that had protocol violations have been included in the analysis.||Participants|||Number
766363|NCT00686803|Primary|Pharmacodynamics as Measured by cGMP Levels.|"Pharmacodynamic parameters were calculated from the baseline-adjusted plasma cGMP level-time data using WinNonlin® 5.0.1. Actual sample times were used in the calculations. Baseline was the pre-dose levels of plasma cGMP at Visit 2 (Day 1): Emax
The patient numbers below represent the evaluable subjects only. The Evaluable Subjects population consisted of subjects who received study drug and who had no major protocol deviations that would have excluded the subject from analysis, and for whom calculations of PD parameters were possible."|24 hours|||ng/mL||Full Range|Median
766364|NCT00686803|Primary|Pharmacokinetics of Subcutaneous (SC) PL-3994 Relative to Placebo in Subjects With Controlled Hypertension.|"The pharmacokinetic profile parameters for PL-3994 were calculated using a non compartmental approach.
•Maximum concentration (Cmax)
The subject numbers below are the evaluable subjects only. The Evaluable Subjects population consisted of subjects who received study drug and who had no major protocol deviations that would have excluded the subject from analysis, and for whom calculations of PK parameters were possible."|24 hours|||ng/mL||Standard Deviation|Mean
766365|NCT00686842|Secondary|Effects of Study Drug on Viral Gene Expression and Cellular Gene Transcription, as Measured by Real-time Quantitative PCR-based Profiling, in Tumor Biopsy Samples||Screening and day 28||||||
766366|NCT00686842|Secondary|Effects of Study Drug on VEGF, VEGFR-2 and -3, Phospho-Akt, p53, and HIF-1α Expression and Tumor Cell Proliferation, as Measured by Ki-67 Staining, in Tumor Biopsy Samples||Screening and day 28||||||
766367|NCT00686842|Secondary|Effects of Study Drug on T-lymphocyte Subsets (i.e., CD4 and CD8)||Screening, day 29, every 3 cycles thereafter, and at treatment discontinuation||||||
766368|NCT00686842|Secondary|Effects of Study Drug on HIV and KSHV Viral Loads||Screening, end of cycle 1, end of every third cycle thereafter, and treatment discontinuation||||||
766369|NCT00686842|Secondary|Effects of Study Drug on Serum and Plasma VEGF, VEGFR, and Cytokine Profiles||On the first day of every 28-day cycle of treatment, Day 15, and treatment discontinuation||||||
766370|NCT00686842|Secondary|Pharmacokinetics||Days 1, 15, 28, 57||||||
766371|NCT00686842|Primary|Response to Treatment||After each 28-day cycle of treatment and at discontinuation of therapy||||||
766372|NCT00686842|Primary|Maximum Tolerated Dose||After each group of 3 subjects completes cycle 1 of treatment||||||
766373|NCT00686842|Primary|Safety and Toxicity of Anti-VEGF Small Molecule PTC299|Patients who experienced an adverse event of grade 3 or greater|All study visits|||participants|||Number
766374|NCT00686855|Primary|The Clinical Efficacy of Topical Steroid and Topical Tacrolimus Therapies for the Treatment of Oral cGHVD.|Participants were given a survey at the time of screening and 4 weeks after start of therapy. The participants self-reported three symptoms of oral cGVHD: oral sensitivity, mouth pain, and mouth dryness. Each symptom was given a score ranging from 0-10, with 0 as none and 10 as the worst. Improvement in subjective scores was defined as 3 points or further reduction from pre-treatment to post-treatment assessment.|Participants were assessed at Baseline and 4 weeks after start of therapy|Of the 46 participants enrolled on the trial, 36 were deemed evaluable for response.||participants|||Number
766375|NCT00686881|Secondary|Number of Participants With Change in Metavir Inflammation Score|Metavir inflammation score is a 4-point scale based on the severity of inflammation in the liver, ranging from A0 (best, no activity) to A3 (worst, severe activity).|Baseline and Week 48|All treated participants excluding 3 participants on the PegIFN-2b arm and 1 participant on the SNMC arm for whom baseline data were non-evaluable or for whom no post-baseline data were available.||Participants|||Number
766376|NCT00686881|Secondary|Number of Participants With Alanine Aminotransferase (ALT) Normalization of >16 Weeks Duration|The ALT was judged to have been normalized when the ALT level was 35 IU/L or below.|Week 24|All treated participants except 1 SNMC participant who had no available data after initial treatment.||Participants|||Number
766377|NCT00686881|Primary|Number of Participants With Change in Metavir Fibrosis Score|Metavir fibrosis score is a 5-point scale based on the amount of fibrosis in the liver, ranging from F0 (best, no fibrosis) to F4 (worst, cirrhosis).|Baseline and discontinuation of treatment (up to 156 weeks)|All treated participants excluding 2 participants on the PegIFN-2B arm and 1 participant on the SNMC arm for whom baseline data were non-evaluable or for whom no post-baseline data were available.||Participants|||Number
766378|NCT00686894|Primary|The Number of Enthesitis Between Week 4 and Week 12 Evaluated Using Power Doppler Ultrasonography (PDUS) and Proprietary Software.|Two measures were to be used for each enthesis evaluation. 1.) Vascularization: yes/no. 2.) Area of hyper-vascularization: mm^2 (continuous) using proprietary software. This study was terminated early due to slow recruitment. As a result, efficacy analyses were not performed.|8 weeks|||Number of Enthesitis|||Number
766379|NCT00686959|Secondary|Percentage of Participants With a Post Baseline Swallowing Diary Score >=4|Participants were provided with a swallowing diary to record issues with swallowing using a 5-point categorical scale: (1) no problems; (2) mild soreness; (3) swallowing solids with some difficulty; (4) inability to swallow solids; and (5) inability to swallow liquids. Participants rated swallowing over the previous 24 hours. The percentage of participants was calculated by dividing the number of with a post baseline swallowing diary score >=4 by total number of participants analyzed, multiplied by 100. No adjustments were made for the number of available assessments nor were any interpolation of missing assessments made.|Baseline through 30 Days Post Study|All randomized participants with at least one post baseline swallowing diary score.||percentage of participants||95% Confidence Interval|Number
766380|NCT00686959|Secondary|First Site of Disease Failure in Terms of Relapse|The percentage of participants with first sites of disease failure in terms of relapse within the radiation treatment field, inside the thorax, (outside of the radiation field), or distant disease are presented. Results were summarized using Kaplan-Meier estimates. Some participants relapsed in more than 1 location/site and appear in more than a single category.|Baseline to Relapse (Up to 66.6 Months)|All randomized participants with objective PD.||percentage of participants||95% Confidence Interval|Number
766381|NCT00686959|Secondary|Survival Rates at 1, 2, and 3 Years|The probability that survival time is at least 1, 2, or 3 years was summarized using Kaplan-Meier estimates.|Baseline to Date of Death from Any Cause (Up to 71.4 Months)|All randomized participants. Arm A had 124 participants censored and Arm B had 117 participants censored.||probability of survival||95% Confidence Interval|Number
766382|NCT00686959|Other Pre-specified|Adverse Events: The Number of Deaths Per Treatment Group|The number of deaths that occurred while on study drug, the number of deaths due to adverse events (AEs) while on study drug, and the number of deaths due to the study disease (that is, disease progression) while on study drug are presented. In addition, the number of deaths within 30 days of treatment discontinuation, the number of deaths due to AEs within 30 days of treatment discontinuation, and the number of deaths due to study disease within 30 days of treatment discontinuation are presented. For both the deaths due to AEs that occurred on study and for deaths due to AEs that occurred within 30 days of treatment discontinuation, the causality (events assess as possibly related [poss related] to study drug per investigator judgement) is also presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 30 Days Post Study|All randomized participants who received at least one dose of study drug.||participants|||Number
766383|NCT00686959|Secondary|Objective Response Rate (Complete Response [CR] + Partial Response [PR])|Overall response rate (ORR) is the best response of CR or PR as classified by the investigators according to the Response Evaluation Criteria in Solid Tumors (RECIST, v1.1) guidelines. CR is defined as the disappearance of all target and non-target lesions, normalization of tumor marker level of non-target lesions, and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm). PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with at least 1 measurable lesion, multiplied by 100.|Baseline to Measured Progressive Disease (Up to 7 Months)|All randomized participants.||percentage of participants||95% Confidence Interval|Number
766384|NCT00686959|Secondary|Progression-free Survival (PFS)|Progression-free survival (PFS) time is from baseline to the first date of documented objective progressive disease (PD) or death from any cause. For participants who were not known to have died or to have had objective PD as of the data inclusion cut-off date for a particular analysis, PFS was censored at the date of the last objective progression-free disease assessments. For participants who took any subsequent systemic anticancer therapy prior to progression or death, PFS was censored at the date of the last objective progression-free disease assessment prior to the start date of any subsequent systemic anticancer therapy. PFS time was summarized using Kaplan-Meier estimates.|Baseline to Measured Progressive Disease or Death from Any Cause (Up to 66.6 Months)|All randomized participants. Arm A had 99 participants censored and Arm B had 87 participants censored.||months||95% Confidence Interval|Median
766385|NCT00686959|Primary|Overall Survival|Overall survival (OS) time is from baseline to the date of death from any cause. For participants not known to have died as of the data cut-off date, OS time was censored at the last contact date the participant was known to be alive prior to the data cut-off date. OS was summarized using Kaplan-Meier estimates.|Baseline to Date of Death from Any Cause (Up to 71.4 Months)|All randomized participants. Arm A had 124 participants censored and Arm B had 117 participants censored.||months||95% Confidence Interval|Median
766386|NCT00686972|Primary|Insulin Secretion||2 years|The PI left the institution and this study was terminated due to noncompliance with our Institutional Review Board. Outcome measure data, if collected, is unknown since no data are available.|||||
766387|NCT00686998|Primary|Positive and Negative Syndrome Scale (PANSS) Total Score Change From Baseline|PANSS total score, sum of 30 item scores (each on a 0 to 7 scale), assesses positive and negative symptoms of psychopathology on a continuous scale from 0 (the best) to 210 (the worst). Day 28 value was calculated using last observation carried forward (LOCF). Change from baseline was calculated as Day 28 value minus baseline value.|Baseline, Day 28|||Points on a scale||Standard Error|Mean
766389|NCT00687076|Secondary|Change in Total Cholesterol (mg/dl) From Baseline to Month 12|Lipids: Total cholesterol (mg/dl); Lipid Data at 12-Months (change from baseline) [mg/dl].|Measured at baseline and 12 months|All values are medians and interquartile range (IQR). P-values were calculated with the KruskaleWallis rank test.||mg/dl||Inter-Quartile Range|Median
766390|NCT00687076|Primary|Effect of Intensive Lipid Modification Medication Therapy on Progression of Atherosclerosis and Restenosis of Femoral Arteries Measured Using High Resolution Magnetic Resonance Imaging (MRI) to Examine the Femoral Artery for Progression of Atherosclerosis|"The primary outcome variable was the change in superficial femoral artery (SFA) wall volume over 24-months, as determined by MRI. The 24-month changes in SFA lumen and SFA total vessel volumes were also analyzed.
Analysis details: A total of 102 patients were randomized. 87 patients completed baseline MRI. Between randomization and the baseline visit, 1 patient withdrew from the study, 8 patients opted out from baseline imaging, and 6 additional patients declined blood collection at baseline. The multilevel models (primary endpoint) used all available imaging data (n=91), including patients who only completed baseline imaging (n=20) or completed at least 2 imaging visits other than baseline (n=4)."|Measured at baseline and Months 6, 12, and 24|Multilevel models were used to describe changes over time in the MRI outcome variables and to compare the drug therapy groups. The advantage of multilevel models is the capability to use data with missing or irregularly timed observations, due to death or loss to follow-up, on the outcome variable.||mm^3, at 24-months||Standard Error|Mean
766391|NCT00687167|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 1, 2, 3, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 9, 10, 11, 12, 14, 16, 24, 36, 48, 60 and 72 hours after drug administration.|||ng-hr/mL||Standard Deviation|Mean
766392|NCT00687167|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that the drug reaches in the plasma.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 1, 2, 3, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 9, 10, 11, 12, 14, 16, 24, 36, 48, 60 and 72 hours after drug administration.|||ng/mL||Standard Deviation|Mean
766393|NCT00687193|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) - Mental Component Summary (MCS)|"SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Change = score at Week 12 minus score at baseline."|Baseline, Week 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.||Units on a scale||Standard Error|Least Squares Mean
766394|NCT00687193|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) - Physical Component Summary (PCS)|"SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Change = score at Week 12 minus score at baseline."|Baseline, Week 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.||Units on a scale||Standard Error|Least Squares Mean
766395|NCT00687193|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Mental Health Domain|"SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Change = score at Week 12 minus score at baseline."|Baseline, Week 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.||Units on a scale||Standard Error|Least Squares Mean
766396|NCT00687193|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Role-Emotional Domain|"SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Change = score at Week 12 minus score at baseline."|Baseline, Week 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.||Units on a scale||Standard Error|Least Squares Mean
766397|NCT00687193|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Social Functioning Domain|"SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Change = score at Week 12 minus score at baseline."|Baseline, Week 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.||Units on a scale||Standard Error|Least Squares Mean
766398|NCT00687193|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Vitality Domain|"SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Change =score at Week 12 minus score at baseline"|Baseline, Week 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.||Units on a scale||Standard Error|Least Squares Mean
766467|NCT00679939|Post-Hoc|Adjusted Change From Baseline in Femoral Neck (FN) Supero-anterior Cortical Thickness Via QCT at Week 76 + 30 Days|Cortical thickness was measured by QCT. Change from baseline was calculated as thickness at Week 76 + 30 days minus thickness at Baseline.|Baseline and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||millimeters||Standard Error|Mean
766399|NCT00687193|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -General Health Domain|"SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Change = score at Week 12 minus score at baseline."|Baseline, Week 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.||Units on a scale||Standard Error|Least Squares Mean
766400|NCT00687193|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Bodily Pain Domain|"SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Change = score at Week 12 minus score at baseline."|Baseline, Week 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.||Units on a scale||Standard Error|Least Squares Mean
766401|NCT00687193|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Role-Physical Domain|"SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Change = score at Week 12 minus score at baseline."|Baseline, Week 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.||Units on a scale||Standard Error|Least Squares Mean
766402|NCT00687193|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Physical Functioning Domain|"SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Change = score at Week 12 minus score at baseline."|Baseline, Week 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.||Units on a scale||Standard Error|Least Squares Mean
766403|NCT00687193|Secondary|Change From Baseline in Euro Quality of Life (EQ-5D)|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. Change = score at Week 12 minus score at baseline."|Baseline, Week 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.||Units on a scale||Standard Error|Least Squares Mean
766404|NCT00687193|Secondary|Area Under Curve (AUC) for Change From Baseline in American College of Rheumatology-N (ACR-N)|ACR-N = calculated for each participant by taking lowest percentage improvement in (1) swollen joint count or (2) tender joint count or (3) the median of remaining 5 components of ACR response (participant's assessment of disease activity; participant's global assessment of pain; physician's assessment of disease activity; participant's assessment of physical function; an acute phase reactant value - CRP). Negative numbers indicate worsening. The AUC for ACR-N is measure of the area under the curve of the mean change from baseline in ACR-N. The trapezoidal rule was used to compute AUC.|Baseline, Week 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were handled using the Last Observation Carried Forward (LOCF) method.||units on a scale||Standard Error|Least Squares Mean
766405|NCT00687193|Secondary|Change From Baseline in C- Reactive Protein (CRP) (mg/L)|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Change = value at observation minus value at baseline.|Baseline, Week 2, 4, 8 and 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.||mg/L||Standard Error|Least Squares Mean
766406|NCT00687193|Secondary|Change From Baseline in Physician’s Global Assessment of Arthritis|Physician Global Assessment of Disease Activity was measured on a 0 to 100 mm Visual Analog Scale (VAS), with 0 mm = no disease activity; very good and 100 mm = worst disease activity; very poor. Change = score at observation minus score at baseline.|Baseline, Week 2, 4, 8 and 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.||Units on a scale||Standard Error|Least Squares Mean
766407|NCT00687193|Secondary|Change From Baseline in Patient’s Global Assessment of Arthritis|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm Visual Analog Scale where 0 = very well and 100 = very poorly. Change = score at observation minus score at baseline."|Baseline, Week 2, 4, 8 and 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.||Units on a scale||Standard Error|Least Squares Mean
766408|NCT00687193|Secondary|Change From Baseline in Patient’s Assessment of Pain|"Change from Baseline in Patient’s Assessment of Arthritis Pain -VAS (0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain) was computed as Week 2, 4, 8 or 12 values minus baseline value. A negative value in change from baseline indicates an improvement.
Change = value at observation minus value at baseline."|Baseline, Week 2, 4, 8 and 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.||Units on a scale||Standard Error|Least Squares Mean
771005|NCT00721188|Primary|Area Under the Serum Concentration-time Curve Extrapolated to Infinity (AUC 0-∞)||Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.|||ug/dL||Standard Deviation|Mean
766409|NCT00687193|Secondary|Change From Baseline in Swollen Joint Count (SJC)|Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1. A negative value in change from baseline indicates an improvement. Change = value at observation minus value at baseline.|Baseline, Week 2, 4, 8 and 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.||units on a scale||Standard Error|Least Squares Mean
766410|NCT00687193|Secondary|Change From Baseline in Painful and Tender Joint Counts|Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1. A negative value in change from baseline indicates an improvement. Change = value at observation minus value at baseline.|Baseline, Weeks 2, 4, 8 and 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.||units on a scale||Standard Error|Least Squares Mean
766411|NCT00687193|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)|"HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
Change = score at observation minus score at baseline."|Baseline, Week 2, 4, 8 and 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.||Units on a scale||Standard Error|Least Squares Mean
766412|NCT00687193|Secondary|Change From Baseline in Disease Activity Score Based on 28-Joints Count Using Erythrocyte Sedimentation Rate [DAS28-4(ESR)]|"The DAS28-4 (ESR) score is a measure of the participant’s disease activity. It is based on the painful and tender joint count (28 joints), swollen joint count (28 joints), participant’s global assessment of disease activity (mm), and ESR. DAS28-4(ESR) scores range from 0 - 10; higher scores indicated greater affectation due to disease activity.
Change = score at observation minus score at baseline."|Baseline, Week 2, 4, 8 and 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.||Units on a scale||Standard Error|Least Squares Mean
766413|NCT00687193|Secondary|Change From Baseline in Disease Activity Score Based on 28-Joints Count Using C-reactive Protein [DAS28-3(CRP)]|"The DAS28-3 (CRP) score is a measure of the perticipant’s disease activity. It is based on the painful and tender joint count (28 joints), swollen joint count (28 joints) and CRP. DAS28-3 (CRP) scores range from 0 - 10; higher scores indicated greater affectation due to disease activity.
Change = value at observation minus value at baseline"|Baseline, Week 2, 4, 8 and 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.||Units on a scale||Standard Error|Least Squares Mean
766414|NCT00687193|Secondary|Number of Participants Achieving American College of Rheumatology 90% (ACR90) Response|ACR90 response: greater than or equal to (>=) 90 percent (%) improvement in painful and tender joint count; >= 90% improvement in swollen joint count; and >= 90% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP) at each visit.|Week 2, 4, 8 and 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were handled using the Last Observation Carried Forward (LOCF) method.||participants|||Number
766415|NCT00687193|Secondary|Number of Participants Achieving American College of Rheumatology 70% (ACR70) Response|ACR70 response: greater than or equal to (>=) 70 percent (%) improvement in painful and tender joint count; >= 70% improvement in swollen joint count; and >= 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP) at each visit.|Week 2, 4, 8 and 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were handled using the Last Observation Carried Forward (LOCF) method.||participants|||Number
766416|NCT00687193|Secondary|Number of Participants Achieving American College of Rheumatology 50% (ACR50) Response|ACR50 response: greater than or equal to (>=) 50 percent (%) improvement in painful and tender joint count; >= 50% improvement in swollen joint count; and >= 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP) at each visit.|Week 2, 4, 8 and 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were handled using the Last Observation Carried Forward (LOCF) method.||participants|||Number
766417|NCT00687193|Secondary|Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Weeks 2, 4 and 8|ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in painful and tender joint count; >= 20% improvement in swollen joint count; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP)at each visit.|Week 2, 4, and 8|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were handled using the Last Observation Carried Forward (LOCF) method.||participants|||Number
766600|NCT00680914|Secondary|Anti-PD Antibody Concentration|Concentration of anti-PD antibody given as GMC expressed in EL.U/mL.|One month after administration of 3rd vaccine dose of the pneumococcal conjugate vaccine|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.||EL.U/mL||95% Confidence Interval|Geometric Mean
766418|NCT00687193|Primary|Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12|ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in painful and tender joint count; >= 20% improvement in swollen joint count; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Week 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were handled using the Last Observation Carried Forward (LOCF) method.||participants|||Number
766419|NCT00687219|Secondary|Number of Participants With Undetectable HCV-RNA at End of Treatment|Serum HCV-RNA was qualitatively measured by reverse transcriptase polymerase chain reaction (RT-PCR)|Up to 48 weeks|||Participants|||Number
766420|NCT00687219|Secondary|Number of Participants With Undetectable HCV-RNA at Week 24|Serum HCV-RNA was qualitatively measured by reverse transcriptase polymerase chain reaction (RT-PCR)|Week 24|Peginterferon alfa-2b administered at 1.0 μg/kg/week SC for 48 weeks plus ribavirin administered based on body weight and hemoglobin value at screening: 600-1000 mg/day for subjects with hemoglobin value at screening >=14g/dL, and 400-800 mg/day for subjects with hemoglobin value at screening >=12g/dL and <14g/dL for 48 weeks||Participants|||Number
766421|NCT00687219|Primary|Number of Participants With Undetectable HCV-RNA at Week 72 (Sustained Virologic Response)|Serum HCV-RNA was qualitatively measured by reverse transcriptase polymerase chain reaction (RT-PCR)|Measured at 24 weeks after 48 weeks treatment (72 weeks)|||Participants|||Number
766422|NCT00687297|Secondary|Progression-free Survival|Time from randomization to first evidence of disease progression or death. Patients alive without progression are censored at the date of last disease evaluation.|every 2 cycles (every 6 weeks during induction, every 8 weeks during maintenance)|All randomized patients were included.||months||95% Confidence Interval|Median
766423|NCT00687297|Secondary|Objective Response Rate|Best overall response (complete or partial response), assessed using RECIST criteria (version 1.0)|Assessed every 2 cycles (1 cycle = 3 weeks during induction and 4 weeks during maintenance))|All randomized patients were included.||percentage of participants||95% Confidence Interval|Number
766424|NCT00687297|Primary|Progression-free Survival|Time from randomization (prior to induction) to first evidence of disease progression or death without progression. Participants alive without progression were censored at the date of last disease evaluation.|Assessed every 2 cycles (1 cycle = 3 weeks during induction and 4 weeks during maintenance))|All randomized patients were included.||Months||95% Confidence Interval|Median
766425|NCT00687323|Secondary|Quality of Life (QoL) in Participants Receiving Long Term Temozolomide Therapy Assessed by Functional Assessment of Cancer Therapy (FACT)-G|The FACT-G was a 27-item questionnaire developed to assess the QoL in patients with chronic illnesses. Scores ranged from 0 to 28. For physical well being, lower scores indicated a better outcome. For functional well being, higher scores indicated a better outcome. For social & emotional well being, whether a high score or a lower one indicated a better outcome depended on the question.|Baseline and post-study visit (63 weeks)|Analysis could not be performed due to incomplete data.|||||
766426|NCT00687323|Secondary|Quality of Life (QoL) in Participants Receiving Long Term Temozolomide Therapy Assessed by EORTC QLQ-LC13|The EORTC QLQ-LC13 was a 13-item questionnaire developed to supplement the EORTC QLQ-C30 in lung cancer patients. It had a score range 0-100 with higher scores representing an increase in symptoms.|Baseline and post-study visit (63 weeks)|Analysis could not be performed due to incomplete data.|||||
766427|NCT00687323|Secondary|Quality of Life (QoL) in Participants Receiving Long Term Temozolomide Therapy Assessed by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-30|The EORTC QLQ-C30 was a 30-item questionnaire developed to assess the QoL of cancer patients. Scores ranged from 0 -100. For functional and global QoL scales, higher scores meant a better level of function. For symptom-oriented scales, a higher score meant more severe symptoms and a decrease in QoL.|Baseline and post-study visit (63 weeks)|Analysis could not be performed due to incomplete data.|||||
766428|NCT00687323|Secondary|Progression-free Survival for Participants Achieving PR, MLSF, or MR|Progression-free survival was defined as time to disease progression. Morphologic leukemia-free state (MLFS): complete clearance of blasts from marrow and blood, but criteria for CR or CRp not met. Partial response (PR): decrease ≥ 50% BM blasts. Minimal Response (MR): decrease ≥ 25% but <50% BM blasts.|Start of treatment until disease progression [up to 1 year after treatment ends (up to 115 weeks)]|Efficacy evaluable population (all eligible participants who completed at least one additional disease evaluation after baseline) who achieved PR, MLSF, or MR||months||95% Confidence Interval|Median
766429|NCT00687323|Secondary|Number of Participants With CR, PR, or MLFS Who Received Modified Low Dose Maintenance Therapy (100 mg/m^2/Day x21 Days of Each 28 Day Cycle) and Experienced Toxicity|Toxicity was defined as any adverse event experienced by a participant regardless of causal relationship with study treatment. An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which did not necessarily have a causal relationship with the treatment. Adverse events may have included the onset of new illness and/or the exacerbation of preexisting conditions.|From first dose to 30 days after last dose of study drug (up to 67 weeks)|Number of participants who achieved CR, PR, or MLFS and received modified low dose maintenance therapy||participants|||Number
766430|NCT00687323|Secondary|MGMT Expression in Leukemic Blasts at the Time of Relapse|"Low MGMT expression was defined as MGMT/β-actin ratio of <0.2.
MGMT & β-actin are cancer biomarkers."|Up to 1 year after treatment ends (up to 115 weeks)|Analysis could not be performed due to lack of specimens.|||||
766431|NCT00687323|Secondary|Number of Previously Untreated Participants With Low O6-Methylguanine Methyltransferase (MGMT) Expression|Low MGMT expression was defined as MGMT/β-actin ratio < 0.2. MGMT & β-actin are cancer biomarkers.|Baseline|All screened participants||participants|||Number
766444|NCT00679783|Primary|Objective Response Rate (ORR) Evaluated According to Response Evaluation Criteria In Solid Tumors (RECIST) Guidelines|Percentage of participants with confirmed best RECIST response of complete response (CR) or partial response (PR). Patients with a best RECIST response of CR or PR had to have a confirmed response at least 28 days later.|Each patient with measurable disease at baseline was assessed for Objective Response from the sequence of RECIST scan data up to data cut-off, 26 March 2010. RECIST scans were performed every 8 weeks (+/- 2 weeks) from randomization.|||Percentage of participants||95% Confidence Interval|Number
766432|NCT00687323|Secondary|Overall Survival (OS) in Participants Achieving CR or CRp and Proceeding to Reduced Dose-intensity Maintenance Therapy With Temozolomide|"OS was defined as the time from start of treatment until death or end of study.
Complete Response (CR): < 5% blasts in normocellular bone marrow (BM); Absolute Neutrophil Count (ANC) > 1.0 x 10^9/L, platelets > 100 x 10^9/L, and no extramedullary disease. CR with incomplete platelet recovery (CRp): All the criteria of CR but with platelets < 100 x 10^9/L but ≥ 50 x 10^9/L and platelet transfusion independent."|Start of treatment until death or end of study [up to 1 year after treatment ends (up to 115 weeks)]|Efficacy evaluable population (all eligible participants who completed at least one additional disease evaluation after baseline)||months||95% Confidence Interval|Median
766433|NCT00687323|Secondary|Relapse-free Survival in Participants Achieving CR or CRp and Proceeding to Reduced Dose-intensity Maintenance Therapy With Temozolomide|Relapse-free survival was defined as time to disease progression. Complete Response (CR): < 5% blasts in normocellular bone marrow (BM); Absolute Neutrophil Count (ANC) > 1.0 x 10^9/L, platelets > 100 x 10^9/L, and no extramedullary disease. CR with incomplete platelet recovery (CRp): All the criteria of CR but with platelets < 100 x 10^9/L but ≥ 50 x 10^9/L and platelet transfusion independent.|Start of treatment until disease progression [up to 1 year after treatment ends (up to 115 weeks)]|Efficacy evaluable population (all eligible participants who completed at least one additional disease evaluation after baseline)||months||95% Confidence Interval|Median
766434|NCT00687323|Secondary|Duration of Response in Participants Achieving Complete Response (CR) and Proceeding to Reduced Dose-intensity Maintenance Therapy With Temozolomide|Complete Response (CR): < 5% blasts in normocellular bone marrow (BM); Absolute Neutrophil Count (ANC) > 1.0 x 10^9/L, platelets > 100 x 10^9/L, and no extramedullary disease.|Up to 1 year after treatment ends (up to 115 weeks)|Efficacy evaluable population (all eligible participants who completed at least one additional disease evaluation after baseline)||Days||Full Range|Median
766435|NCT00687323|Primary|Clinical Response at the End of Temozolomide Induction|"Complete Response (CR): < 5% blasts in normocellular bone marrow (BM); Absolute Neutrophil Count (ANC) > 1.0 x 10^9/L, platelets > 100 x 10^9/L, and no extramedullary disease.
CR with incomplete platelet recovery (CRp): All the criteria of CR but with platelets < 100 x 10^9/L but ≥ 50 x 10^9/L and platelet transfusion independent.
Morphologic leukemia-free state (MLFS): complete clearance of blasts from marrow and blood, but criteria for CR or CRp not met.
Partial response (PR): decrease ≥ 50% BM blasts. Minimal Response (MR): decrease ≥ 25% but <50% BM blasts."|at the end of each cycle (approximately 4 weeks post start of cycle), up to a maximum 63 weeks|Efficacy evaluable population (all eligible participants who completed at least one additional disease evaluation after baseline)||participants|||Number
766436|NCT00687362|Primary|Psoriasis Area and Severity Index 75 (PASI75) Response at Week 10|"PASI 75 response is defined as participants who achieved at least a 75% improvement in PASI score from Baseline to Week 10.
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 to 72 (the higher the number, the worse the disease)."|10 weeks|||participants|||Number
766437|NCT00687401|Primary|Number of Participants Who Achieve a Greater Than or Equal to 75% Improvement in Psoriasis Area and Severity Index (PASI) Score|"PASI 75 response is defined as participants who achieved at least a
75% improvement in PASI score from Baseline to Week 10. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their responses to therapy. The PASI produces a numeric score that can range from 0 to 72 (the higher the number, the worse the disease)."|10 weeks|"Intent to Treat Population (ITT): 159 participants out of the 215 enrolled patients who received at least one dose of the study drug.
Per Protocol Population (PP): 138 participants not withdrawn from the study due to major protocol violation and who have received the three infusions of the study drug planned by the protocol."||Participants|||Number
766438|NCT00687440|Primary|Number of Participants Who Had a Tumor Response, According to Standard RECIST (Response Evaluation Criteria in Solid Tumors) Criteria|Those who achieved either complete (disappearance of all target lesions) or partial (at least 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD) response.|Week 09, Week 18, at the end of each patient's treatment, and at 3, 6, 9, and 12 months after end of treatment.|Intent-to-treat population||Participants|||Number
766439|NCT00679783|Secondary|Progression Free Survival (PFS)|PFS is defined as the time from first dose to the earlier date of radiologic progression (as per Response Evaluation Criteria In Solid Tumours (RECIST) criteria or death by any cause in the absence of objective progression.|RECIST tumour assessments carried out every 8 weeks from randomization (+/- 2 weeks) until data cut-off on 26 March 2010.|||Days||Full Range|Median
766440|NCT00679783|Secondary|CA-125 Levels (Ovarian Cancer Patients Only)|A response according to CA-125 has occurred if there is at least a 50% reduction in CA-125 levels from a pre-treatment sample.|24 weeks|||Percentage of participants||95% Confidence Interval|Number
766441|NCT00679783|Secondary|Best Percentage Change From Baseline in Tumour Size|The best percentage change (reduction) from baseline in tumour size (defined as the sum of the longest diameters as measured among all target lesions).|Each patient with measurable disease at baseline was assessed for best percentage change in tumour size from the sequence of RECIST scan data up to data cut-off, 26 March 2010. RECIST scans were performed every 8 weeks (+/- 2 weeks) from randomization.|||Percentage||Full Range|Median
766442|NCT00679783|Secondary|Duration of Response|Duration of response is measured from the time the measurement criteria for CR or PR are met (whichever is first recorded) until the patient progresses (per RECIST criteria). If patient did not progress, they are censored at their last objective tumour assessment date.|RECIST tumour assessments carried out every 8 weeks from randomization (+/- 2 weeks) until data cut-off on 26 March 2010.|||Days||Full Range|Median
766443|NCT00679783|Secondary|Disease Control Rate (DCR)|Percentage of participants with confirmed best Response Evaluation Criteria In Solid Tumours (RECIST) response of complete response (CR), partial response (PR) orStable Disease (SD)|16 Weeks|||Percentage of participants||95% Confidence Interval|Number
766445|NCT00679913|Secondary|Morbidity|Number of participants with morbidity, such as bleeding, sepsis, pancreatic fistula, intra-abdominal abscess, wound infection, delayed gastric emptying, and diarrhea after standard and extended pancreaticoduodenectomy|within 2 years after surgery|||participants|||Number
766446|NCT00679913|Primary|Survival|comparison of 2-year overall survival rate between standard and extended pancreaticoduodenectomy; number of surviving participants 2 years after surgery|2 year after surgery|||participants|||Number
766447|NCT00679939|Post-Hoc|Adjusted Change in Albumin-adjusted Serum Calcium (AASC) From Week 52 to Week 76|AASC levels were measured from blood samples. AASC is the amount of free calcium circulating in the blood and calcium is required for good bone health. Change from Week 52 was calculated as the Week 76 value minus the Week 52 value and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region.|Week 52 and Week 76|Safety Population. Only evaluable participants with a value at Week 52 and at Week 76 for the parameter of interest were analyzed.||millimoles per Liter (mmol/L)||Standard Error|Mean
766448|NCT00679939|Post-Hoc|Adjusted Change From Baseline in Albumin-adjusted Serum Calcium (AASC) at Week 52 and Week 76|AASC levels were measured from blood samples. AASC is the amount of free calcium circulating in the blood and calcium is required for good bone health. Change from baseline was calculated as the Week 52or Week 76 value minus the baseline value and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region.|Baseline, Week 52, and Week 76|Safety Population. Only evaluable participants with a value at Baseline and at Week 52 or Week 76 for the parameter of interest were analyzed.||millimoles per Liter (mmol/L)||Standard Error|Mean
766449|NCT00679939|Post-Hoc|Adjusted Change in Femoral Neck (FN) Infero-anterior Cortical Thickness Via QCT From Week 52 + 30 Days to Week 76 + 30 Days|Cortical thickness was measured by QCT. Change was calculated as thickness at Week 76 + 30 days minus thickness at Week 52 + 30 days.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||millimeters||Standard Error|Mean
766450|NCT00679939|Post-Hoc|Adjusted Percent Change in Femoral Neck (FN) Infero-anterior Cortical Thickness Via QCT From Week 52 + 30 Days to Week 76 + 30 Days|Cortical thickness (measured in millimeters) was measured by QCT. Percent change was calculated as (thickness at Week 76 + 30 days minus thickness at Week 52 + 30 days)/thickness at Week 52 + 30 days x 100%.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||percent change||Standard Error|Mean
766451|NCT00679939|Post-Hoc|Adjusted Change From Baseline in Femoral Neck (FN) Infero-anterior Cortical Thickness Via QCT at Week 76 + 30 Days|Cortical thickness was measured by QCT. Change was calculated as thickness at Week 76 + 30 days minus thickness at Baseline.|Baseline and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||millimeters||Standard Error|Mean
766452|NCT00679939|Post-Hoc|Adjusted Percent Change From Baseline in Femoral Neck (FN) Infero-anterior Cortical Thickness Via QCT at Week 52 + 30 Days and Week 76 + 30 Days|Cortical thickness (measured in millimeters) was measured by QCT. Percent change was calculated as (thickness at Week 52 + 30 days (orWeek 76 + 30 days) minus thickness at Baseline)/thickness at Baseline x 100%.|Baseline, Week 52 + 30 days, and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||percent change||Standard Error|Mean
766453|NCT00679939|Post-Hoc|Adjusted Change in Femoral Neck (FN) Infero-anterior Cortical vBMD Via QCT From Week 52 + 30 Days to Week 76 + 30 Days|vBMD was measured by QCT. Change from Week 52 + 30 days to Week 76 + 30 days was calculated as vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Infero-anterior is the lower and front section of the FN.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||mg/cm^3||Standard Error|Mean
766454|NCT00679939|Post-Hoc|Adjusted Percent Change in Femoral Neck (FN) Infero-anterior Integral, Trabecular, and Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days|vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Week 52 + 30 days to Week 76 + 30 days was calculated as (vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days)/vBMD at Week 52 + 30 days x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Infero-anterior is the lower and front section of the FN.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||percent change||Standard Error|Mean
766455|NCT00679939|Post-Hoc|Adjusted Change From Baseline in Femoral Neck (FN) Infero-anterior Cortical vBMD Via QCT at Week 76 + 30 Days|vBMD was measured by QCT. Change from Baseline at Week 76 + 30 days was calculated as vBMD at Week 76 + 30 days minus vBMD at baseline and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Infero-anterior is the lower and front section of the FN.|Baseline and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||mg/cm^3||Standard Error|Mean
766456|NCT00679939|Post-Hoc|Adjusted Percent Change From Baseline in Femoral Neck (FN) Infero-anterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days|vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Baseline at Week 52 + 30 days or Week 76 + 30 days was calculated as (vBMD at Week 52 + 30 days (orWeek 76 + 30 days) minus vBMD at baseline)/vBMD at Baseline x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Infero-anterior is the lower and front section of the FN.|Baseline, Week 52 + 30 days, and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||percent change||Standard Error|Mean
766641|NCT00687531|Secondary|Number of Participants With Use of Rescue Medication in Each Episode||Day 1 and Week 12|This analysis was not performed due to missing data at the sites.|||episodes||
775450|NCT00756977|Secondary|Serum Chemistry Results (mEq/L)|Change from Baseline|2 days|Intent-to-treat population: all patients that took any portion of the study preparation.||mEq/L||Standard Deviation|Mean
766457|NCT00679939|Post-Hoc|Adjusted Change in Femoral Neck (FN) Infero-posterior Cortical Thickness Via QCT From Week 52 + 30 Days to Week 76 + 30 Days|Cortical thickness was measured by QCT. Change was calculated as thickness at Week 76 + 30 days minus thickness at Week 52 + 30 days.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||millimeters||Standard Error|Mean
766458|NCT00679939|Post-Hoc|Adjusted Percent Change in Femoral Neck (FN) Infero-posterior Cortical Thickness Via QCT From Week 52 + 30 Days to Week 76 + 30 Days|Cortical thickness (measured in millimeters) was measured by QCT. Percent change was calculated as (thickness at Week 76 + 30 days minus thickness at Week 52 + 30 days)/thickness at Week 52 + 30 days x 100%.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||percent change||Standard Error|Mean
766459|NCT00679939|Post-Hoc|Adjusted Change From Baseline in Femoral Neck (FN) Infero-posterior Cortical Thickness Via QCT at Week 76 + 30 Days|Cortical thickness was measured by QCT. Change from Baseline was calculated as thickness at Week 76 + 30 days minus thickness at Baseline.|Baseline and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||millimeters||Standard Error|Mean
766460|NCT00679939|Post-Hoc|Adjusted Percent Change From Baseline in Femoral Neck (FN) Infero-posterior Cortical Thickness Via QCT at Week 52 + 30 Days and Week 76 + 30 Days|Cortical thickness (measured in millimeters) was measured by QCT. Percent change was calculated as (thickness at Week 52 + 30 days (or Week 76 + 30 days) minus thickness at Baseline)/thickness at Baseline x 100%.|Baseline, Week 52 + 30 days, and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||percent change||Standard Error|Mean
766461|NCT00679939|Post-Hoc|Adjusted Change in Femoral Neck (FN) Infero-posterior Cortical vBMD Via QCT From Week 52 + 30 Days to Week 76 + 30 Days|vBMD was measured by QCT. Change from Week 52 + 30 days to Week 76 + 30 days was calculated as vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Infero-posterior is the lower and back section of the FN.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||mg/cm^3||Standard Error|Mean
766462|NCT00679939|Post-Hoc|Adjusted Percent Change in Femoral Neck (FN) Infero-posterior Integral, Trabecular, and Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days|vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Week 52 + 30 days to Week 76 + 30 days was calculated as (vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days)/vBMD at Week 52 + 30 days x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Infero-posterior is the lower and back section of the FN.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||percent change||Standard Error|Mean
766463|NCT00679939|Post-Hoc|Adjusted Change From Baseline in Femoral Neck (FN) Infero-posterior Cortical vBMD Via QCT at Week 76 + 30 Days|vBMD was measured by QCT. Change from Baseline at Week 76 + 30 days was calculated as vBMD at Week 76 + 30 days minus vBMD at baseline and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Infero-posterior is the lower and back section of the FN.|Baseline and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||mg/cm^3||Standard Error|Mean
766464|NCT00679939|Post-Hoc|Adjusted Percent Change From Baseline in Femoral Neck (FN) Infero-posterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days|vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Baseline at Week 52 + 30 days or Week 76 + 30 days was calculated as (vBMD at Week 52 + 30 days (or Week 76 + 30 days) minus vBMD at baseline)/vBMD at Baseline x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Infero-posterior is the lower and back section of the FN.|Baseline, Week 52 + 30 days, and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||percent change||Standard Error|Mean
766465|NCT00679939|Post-Hoc|Adjusted Change in Femoral Neck (FN) Supero-anterior Cortical Thickness Via QCT From Week 52+30 Days to Week 76 + 30 Days|Cortical thickness was measured by QCT. Change was calculated as thickness at Week 76 + 30 days minus thickness at Week 52 + 30 days.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||millimeters||Standard Error|Mean
766466|NCT00679939|Post-Hoc|Adjusted Percent Change in Femoral Neck (FN) Supero-anterior Cortical Thickness Via QCT From Week 52 + 30 Days to Week 76 + 30 Days|Cortical thickness (measured in millimeters) was measured by QCT. Percent change was calculated as (thickness at Week 76 + 30 days minus thickness at Week 52 + 30 days)/thickness at Week 52 + 30 days x 100%.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||percent change||Standard Error|Mean
766642|NCT00687531|Secondary|Number of Participants Who Adhered to Treatment|The compliance was measured via medication consumption. In the end of the last week of study (Week 12), a review of the remaining study drug in the initial prescribed Twisthaler device was done. A Twisthaler reading of 0 indicates no study drug left and full compliance.|Day 1 to Week 12|study completers (per protocol population)||participants|||Number
766468|NCT00679939|Post-Hoc|Adjusted Percent Change From Baseline in Femoral Neck (FN) Supero-anterior Cortical Thickness Via QCT at Week 52 + 30 Days and Week 76 + 30 Days|Cortical thickness (measured in millimeters) was measured by QCT. Percent change was calculated as (thickness at Week 52 + 30 days(or Week 76 + 30 days) minus thickness at Baseline)/thickness at Baseline x 100%.|Baseline, Week 52 + 30 days, and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||percent change||Standard Error|Mean
766469|NCT00679939|Post-Hoc|Adjusted Change in Femoral Neck (FN) Supero-anterior Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days|vBMD was measured by QCT. Change from Week 52 + 30 days to Week 76 + 30 days was calculated as vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Supero-anterior is the upper and front section of the FN.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||mg/cm^3||Standard Error|Mean
766470|NCT00679939|Post-Hoc|Adjusted Percent Change in Femoral Neck (FN) Supero-anterior Integral, Trabecular, and Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days|vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Week 52 + 30 days to Week 76 + 30 days was calculated as (vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days)/vBMD at Week 52 + 30 days x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Supero-anterior is the upper and front section of the FN.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||percent change||Standard Error|Mean
766471|NCT00679939|Post-Hoc|Adjusted Change From Baseline in Femoral Neck (FN) Supero-anterior Cortical vBMD Via QCT at Week 76 + 30 Days|vBMD was measured by QCT. Change from Baseline at Week 76 + 30 days was calculated as vBMD at Week 76 + 30 days minus vBMD at baseline and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Supero-anterior is the upper and front section of the FN.|Baseline and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||mg/cm^3||Standard Error|Mean
766472|NCT00679939|Post-Hoc|Adjusted Percent Change From Baseline in Femoral Neck (FN) Supero-anterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days|vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Baseline at Week 52 + 30 daysor Week 76 + 30 days was calculated as (vBMD at Week 52 + 30 days(or Week 76 + 30 days) minus vBMD at baseline)/vBMD at Baseline x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Supero-anterior is the upper and front section of the FN.|Baseline, Week 52 plus 30 days, and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||percent change||Standard Error|Mean
766473|NCT00679939|Post-Hoc|Adjusted Change in Femoral Neck (FN) Supero-posterior Cortical Thickness Via QCT From Week 52 + 30 Days to Week 76 + 30 Days|Cortical thickness was measured by QCT. Change was calculated as thickness at Week 76 + 30 days minus thickness at Week 52 + 30 days.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||millimeters||Standard Error|Mean
766474|NCT00679939|Post-Hoc|Adjusted Percent Change in Femoral Neck (FN) Supero-posterior Cortical Thickness Via QCT From Week 52+30 Days to Week 76 + 30 Days|Cortical thickness (measured in millimeters) was measured by QCT. Percent change was calculated as (thickness at Week 76 + 30 days minus thickness at Week 52 + 30 days)/thickness at Week 52 + 30 days x 100%.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||percent change||Standard Error|Mean
766475|NCT00679939|Post-Hoc|Adjusted Change From Baseline in Femoral Neck (FN) Supero-posterior Cortical Thickness Via QCT at Week 76 + 30 Days|Cortical thickness was measured by QCT. Change from baseline was calculated as thickness at Week 76 + 30 days minus thickness at Baseline.|Baseline and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||millimeters||Standard Error|Mean
766476|NCT00679939|Post-Hoc|Adjusted Percent Change From Baseline in Femoral Neck (FN) Supero-posterior Cortical Thickness Via QCT at Week 52 + 30 Days and Week 76 + 30 Days|Cortical thickness (measured in millimeters) was measured by QCT. Percent change was calculated as (thickness at Week 52 + 30 days (or Week 76 + 30 days) minus thickness at Baseline)/thickness at Baseline x 100%|Baseline, Week 52 + 30 days, and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||percent change||Standard Error|Mean
766477|NCT00679939|Post-Hoc|Adjusted Change in Femoral Neck (FN) Supero-posterior Cortical vBMD Via QCT From Week 52 + 30 Days to Week 76 + 30 Days|vBMD was measured by QCT. Change from Week 52 + 30 days to Week 76 + 30 days was calculated as vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therpay, and region. Supero-posterior is the upper and back section of the FN.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||mg/cm^3||Standard Error|Mean
772187|NCT00732940|Primary|Absolute Change From Baseline in CD20+ (Total) B Cells at Week 24||Baseline, 24 weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.||cells/mm^3||Standard Error|Mean
766478|NCT00679939|Post-Hoc|Adjusted Percent Change in Femoral Neck (FN) Supero-posterior Integral, Trabecular, and Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days|vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Week 52 + 30 days to Week 76 + 30 days was calculated as (vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days)/vBMD at Week 52 + 30 days x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therpay, and region. Supero-posterior is the upper and back section of the FN.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||percent change||Standard Error|Mean
766479|NCT00679939|Post-Hoc|Adjusted Change From Baseline in Femoral Neck (FN) Supero-posterior and Cortical vBMD Via QCT at Week 76 + 30 Days|vBMD was measured by QCT. Change from Baseline at Week 76 + 30 days was calculated as vBMD at Week 76 + 30 days minus vBMD at baseline and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Supero-posterior is the upper and back section of the FN.|Baseline and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||mg/cm^3||Standard Error|Mean
766480|NCT00679939|Post-Hoc|Adjusted Percent Change From Baseline in Femoral Neck (FN) Supero-posterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days|vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Baseline at Week 52 + 30 days orWeek 76 + 30 days was calculated as (vBMD at Week 52 + 30 days (or Week 76 + 30 days) minus vBMD at baseline)/vBMD at Baseline x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therpay, and region. Supero-posterior is the upper and back section of the FN.|Baseline, Week 52 + 30 days, and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||percent change||Standard Error|Mean
766481|NCT00679939|Post-Hoc|Adjusted Percent Change in Vertebral Trabecular vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days|BMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Week 52 + 30 days to Week 76 + 30 days was calculated as (vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days)/vBMD at Week 52 + 30 days x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||percent change||Standard Error|Mean
766482|NCT00679939|Post-Hoc|Adjusted Percent Change From Baseline in Vertebral Trabecular vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days|BMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Baseline at Week 52 + 30 days or Week 76 + 30 days was calculated as (vBMD at Week 52 + 30 days (orWeek 76 + 30 days) minus vBMD at baseline)/vBMD at Baseline x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.|Baseline, Week 52 + 30 days, and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||percent change||Standard Error|Mean
766483|NCT00679939|Post-Hoc|Adjusted Percent Change in Intertrochanter Integral, Intertrochanter Trabecular, and Intertrochanter Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days|vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Week 52 + 30 days to Week 76 + 30 days was calculated as (vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days)/vBMD at Week 52 + 30 days x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||percent change||Standard Error|Mean
766484|NCT00679939|Post-Hoc|Adjusted Percent Change From Baseline in Intertrochanter Integral, Intertrochanter Trabecular, and Intertrochanter Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days|vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Baseline at Week 52 + 30 days or Week 76 + 30 days was calculated as (vBMD at Week 52 + 30 days (or Week 76 + 30 days) minus vBMD at baseline)/vBMD at Baseline x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.|Baseline, Week 52 + 30 days, and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||percent change||Standard Error|Mean
766485|NCT00679939|Post-Hoc|Adjusted Percent Change in Trochanter Integral, Trochanter Trabecular, and Trochanter Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days|vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Week 52 + 30 days to Week 76 + 30 days was calculated as (vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days)/vBMD at Week 52 + 30 days x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||percent change||Standard Error|Mean
766505|NCT00679939|Secondary|Adjusted Percent Change in Intact Parathyroid Hormone (PTH) From Week 52 to Week 76|Intact PTH levels were measured in nanograms per Liter (ng/L) from blood samples. Intact PTH is the amount of PTH circulating in the blood and influences bone health. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region.|Week 52 and Week 76|Safety Population. Only evaluable participants with a value at Week 52 and at Week 76 for the parameter of interest were analyzed.||percent change|||Number
766486|NCT00679939|Post-Hoc|Adjusted Percent Change From Baseline in Trochanter Integral, Trochanter Trabecular, and Trochanter Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days|vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Baseline at Week 52 + 30 days or Week 76 + 30 days was calculated as (vBMD at Week 52 + 30 days (or Week 76 + 30 days) minus vBMD at baseline)/vBMD at Baseline x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.|Baseline, Week 52 + 30 days, and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||percent change||Standard Error|Mean
766487|NCT00679939|Post-Hoc|Adjusted Percent Change in Femoral Neck (FN) Integral, FN Trabecular, and FN Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days|vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Week 52 + 30 days to Week 76 + 30 days was calculated as (vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days)/vBMD at Week 52 + 30 days x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||percent change||Standard Error|Mean
766488|NCT00679939|Post-Hoc|Adjusted Percent Change From Baseline in Femoral Neck (FN) Integral, FN Trabecular, and FN Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days|vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Baseline at Week 52 + 30 days or Week 76 + 30 days was calculated as (vBMD at Week 52 + 30 days (orWeek 76 + 30 days) minus vBMD at baseline)/vBMD at Baseline x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.|Baseline, Week 52 + 30 days, and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||percent change||Standard Error|Mean
766489|NCT00679939|Post-Hoc|Adjusted Percent Change in Total Hip (TH) Integral, TH Trabecular, and TH Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days|Volumetric (v)BMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. vBMD is the 3-dimensional density of a region of bone. Cortical bone is dense bone. Trabecular bone is spongy bone. Integral bone is the sum of cortical and trabecular bone measurements. Cortical thickness is the width of the cortical shell. Percent change from Week 52 + 30 days was calculated as (vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days)/ vBMD at Week 52 + 30 days x 100% and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||percent change||Standard Error|Mean
766490|NCT00679939|Post-Hoc|Adjusted Percent Change From Baseline in Total Hip (TH) Integral, TH Trabecular, and TH Cortical vBMD Via QCT at Week 52 + 30 Days and at Week 76 + 30 Days|Volumetric (v)BMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. vBMD is the 3-dimensional density of a region of bone. Cortical bone is dense bone. Trabecular bone is spongy bone. Integral bone is the sum of cortical and trabecular bone measurements. Cortical thickness is the width of the cortical shell. Percent change from Baseline was calculated as (vBMD at Week 52+30 days (or Week 76+30 days) minus vBMD at baseline)/vBMD at Baseline x 100% and was assessed by ANCOVA with terms for treatment, baseline value, prior therapy, and region.|Baseline, Week 52 + 30 days, and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||percent change||Standard Error|Mean
766491|NCT00679939|Post-Hoc|Adjusted Percent Change in Femoral Neck, Total Hip, Trochanter, and Intertrochanter Areal BMD Via Quantitative Computed Tomography (QCT) From Week 52+30 Days to Week 76 + 30 Days|BMD (measured in grams per centimeters squared [g/cm^2]) was measured by QCT. BMD by QCT is the 2-dimensional volume that mimics the DXA measurement for the same region. Percent change from Week 52 + 30 days to Week 76 + 30 days was calculated as (BMD at Week 76 + 30 days minus BMD at Week 52 + 30 days)/BMD at Week 52 + 30 days x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||percent change||Standard Error|Mean
766492|NCT00679939|Post-Hoc|Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Intertrochanter Areal BMD Via Quantitative Computed Tomography (QCT) at Week 52 + 30 Days and Week 76 + 30 Days|BMD (measured in grams per centimeters squared [g/cm^2]) was measured by QCT. BMD by QCT is the 2-dimensional volume that mimics the DXA measurement for the same region. Percent change from Baseline at Week 52 + 30 days orWeek 76 + 30 days was calculated as (BMD at Week 52 + 30 days (orWeek 76 + 30 days) minus BMD at baseline)/BMD at Baseline x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.|Baseline, Week 52 + 30 days, and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||percent change||Standard Error|Mean
766506|NCT00679939|Secondary|Adjusted Percent Change From Baseline in Intact Parathyroid Hormone (PTH) at Week 52 and Week 76|Intact PTH levels were measured in nanograms per Liter (ng/L) from blood samples. Intact PTH is the amount of PTH circulating in the blood and influences bone health. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region.|Baseline, Week 52, and Week 76|Safety Population. Only evaluable participants with a value at Baseline and at Week 52 or Week 76 for the parameter of interest were analyzed.||percent change|||Number
772188|NCT00732940|Secondary|Median Percent Change From Baseline in IgM at Week 24||Baseline, 24 weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.||Percentage||Full Range|Median
766493|NCT00679939|Post-Hoc|Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA at Week 52 + 30 Days and Week 76 + 30 Days|BMD (measured in grams per centimeters squared [g/cm^2]) was measured by DXA. Percent change from Baseline at Week 52 + 30 days or Week 76 + 30 days was calculated as (BMD at Week 52 + 30 days (or Week 76 + 30 days) minus BMD at Baseline)/BMD at Baseline x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.|Baseline, Week 52 + 30 days, and Week 76 + 30 days|Safety Population. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed. Not all participants had the correct positioning for all of the DXA measurements.||percent change||Standard Error|Mean
766494|NCT00679939|Post-Hoc|Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA at Week 52 + 10 Days and Week 76 + 10 Days|BMD (measured in grams per centimeters squared [g/cm^2]) was measured by DXA. Percent change from Baseline at Week 52 + 10 days or Week 76 + 10 days was calculated as (BMD at Week 52 + 10 days (or Week 76 + 10 days ) minus BMD at Baseline)/BMD at Baseline x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.|Baseline, Week 52 + 10 days, and Week 76 + 10 days|Safety Population. Only evaluable participants with a value at Baseline and at Week 52 performed up to 10 days after initiating OL MET or at Week 76 performed up to 10 days after stopping OL MET for the parameter of interest were analyzed. Not all participants had the correct positioning for the DXA lumbar spine measurement.||percent change||Standard Error|Mean
766495|NCT00679939|Other Pre-specified|Percent Change in Free Estradiol From Week 52 to Week 76|Free estradiol levels were measured in picomoles per Liter (pmol/L) from blood samples. Free estrodial is the amount of estrogen available to the body for use. Change was based on log-transformed data.|Week 52 and Week 76|Safety Population. Only evaluable participants with a value at Week 52 and Week 76 for the parameter of interest were analyzed.||percent change|||Number
766496|NCT00679939|Other Pre-specified|Percent Change in Percentage of Free Estradiol From Week 52 to Week 76|Free estradiol levels were measured as a percentage of serum estrogen from blood samples. Free estradiol is the amount of estrogen available to the body for use. Percent change was based on log-transformed data.|Week 52 and Week 76|Safety Population. Only evaluable participants with a value at Week 52 and Week 76 for the parameter of interest were analyzed.||percent change|||Number
766497|NCT00679939|Secondary|Percent Change in Sex Hormone Binding Globulin (SHBG) From Week 52 to Week 76|SHBG levels were measured in nanomoles per liter (nmol/L) from blood samples. SHBG binds to estradiol and testosterone and influences the amount of estradiol or testosterone available to the body for use. Percent change from baseline was based on log-transformed data.|Week 52 and Week 76|Safety Population. Only evaluable participants with a value at Week 52 and at Week 76 for the parameter of interest were analyzed.||percent change|||Number
766498|NCT00679939|Secondary|Percent Change From Baseline in Sex Hormone Binding Globulin (SHBG) at Week 52 and Week 76|SHBG levels were measured in nanomoles per liter (nmol/L) from blood samples. SHBG binds to estradiol and testosterone and influences the amount of estradiol or testosterone available to the body for use. Percent change from baseline was based on log-transformed data.|Baseline, Week 52, and Week 76|Safety Population. Only evaluable participants with a value at Baseline and at Week 52 or Week 76 for the parameter of interest were analyzed.||percent change|||Number
766499|NCT00679939|Secondary|Percent Change in Free Testosterone From Week 52 to Week 76|Free testosterone levels were measured as a percentage of total testosterone from blood samples. Free testosterone is the amount of testosterone available to the body for use. Percent change from baseline was based on log-transformed data.|Week 52 and Week 76|Safety Population. Only evaluable participants with a value at Week 52 and at Week 76 for the parameter of interest were analyzed.||percent change|||Number
766500|NCT00679939|Secondary|Percent Change From Baseline in Free Testosterone at Week 52 and Week 76|Free testosterone levels were measured as a percentage of total testosterone from blood samples. Free testosterone is the amount of testosterone available to the body for use. Percent change from baseline was based on log-transformed data.|Baseline, Week 52, and Week 76|Safety Population. Only evaluable participants with a value at Baseline and at Week 52 or Week 76 for the parameter of interest were analyzed.||percent change|||Number
766501|NCT00679939|Secondary|Percent Change in Total Testosterone From Week 52 to Week 76|Total testosterone levels were measured in nanomoles per Liter (nmol/L) from blood samples. Testosterone is a male sex hormone and influences bone health; total testosterone is the entire amount circulating in blood. Percent change from baseline was based on log-transformed data.|Week 52 and Week 76|Safety Population. Only evaluable participants with a value at Week 52 and at Week 76 for the parameter of interest were analyzed.||percent change|||Number
766502|NCT00679939|Secondary|Percent Change From Baseline in Total Testosterone at Week 52 and Week 76|Total testosterone levels were measured in nanomoles per Liter (nmol/L) from blood samples. Testosterone is a male sex hormone and influences bone health; total testosterone is the entire amount circulating in blood. Percent change from baseline was based on log-transformed data.|Baseline, Week 52, and Week 76|Safety Population. Only evaluable participants with a value at Baseline and at Week 52 or Week 76 for the parameter of interest were analyzed.||percent change|||Number
766503|NCT00679939|Secondary|Percent Change in Serum Estradiol From Week 52 to Week 76|Serum estradiol levels were measured in picomoles per Liter (pmol/L) from blood samples. Estradiol is one form of the female sex hormone estrogen and influences bone health. Percent change from baseline was based on log-transformed data.|Week 52 and Week 76|Safety Population. Only evaluable participants with a value at Week 52 and at Week 76 for the parameter of interest were analyzed.||percent change|||Number
766504|NCT00679939|Secondary|Percent Change From Baseline in Serum Estradiol at Week 52 and Week 76|Serum estradiol levels were measured in picomoles per Liter (pmol/L) from blood samples. Estradiol is one form of the female sex hormone estrogen and influences bone health. Percent change from baseline was based on log-transformed data.|Baseline, Week 52, and Week 76|Safety Population. Only evaluable participants with a value at Baseline and at Week 52 or Week 76 for the parameter of interest were analyzed.||percent change|||Number
766984|NCT00690482|Secondary|Slow Vital Capacity|Mean change in SVC from baseline to Week 4 (last measurement post dose used, if data missing)|Baseline and Week 4|The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.||L||Full Range|Mean
766507|NCT00679939|Secondary|Adjusted Percent Change in 25-Hydroxyvitamin D (Vitamin D) From Week 52 to Week 76|Vitamin D levels were measured in nanomoles per Liter (nmol/L) from blood samples. Vitamin D is required for good bone health. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region.|Week 52 and Week 76|Safety Population. Only evaluable participants with a value at Week 52 and at Week 76 for the parameter of interest were analyzed.||percent change|||Number
766508|NCT00679939|Secondary|Adjusted Percent Change From Baseline in 25-Hydroxyvitamin D (Vitamin D) at Week 52 and Week 76|Vitamin D levels were measured in nanomoles per Liter (nmol/L) from blood samples. Vitamin D is required for good bone health. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region.|Baseline, Week 52, and Week 76|Safety Population. Only evaluable participants with a value at Baseline and at Week 52 or Week 76 for the parameter of interest were analyzed.||percent change|||Number
766509|NCT00679939|Secondary|Adjusted Percent Change in Carboxyterminal Cross-linked Telopeptide of Type 1 Collagen (CTX) From Week 52 to Week 76|CTX levels were measured in picograms per milliliter (pg/ml) from blood samples. CTX is an indicator of bone break down or resorption. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region.|Week 52 and Week 76|Safety Population. Only evaluable participants with a value at Week 52 and at Week 76 for the parameter of interest were analyzed.||percent change|||Number
766510|NCT00679939|Secondary|Adjusted Percent Change From Baseline in Carboxyterminal Cross-linked Telopeptide of Type 1 Collagen (CTX) at Week 52 and Week 76|CTX levels were measured in picograms per milliliter (pg/ml) from blood samples. CTX is an indicator of bone break down or resorption. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region.|Baseline, Week 52, and Week 76|Safety Population. Only evaluable participants with a value at Baseline and at Week 52 or Week 76 for the parameter of interest were analyzed.||percent change|||Number
766511|NCT00679939|Secondary|Adjusted Percent Change in Bone Specific Alkaline Phosphatase (BSAP) and Procollagen Type 1 N-propeptide (P1NP) From Week 52 to Week 76|BSAP and P1NP levels were measured in micrograms per liter (mcg/L) from blood samples. BSAP and P1NP are indicators of bone buildup or formation. GM, geometric mean; SE, standard error. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region.|Week 52 and Week 76|Safety Population. Only evaluable participants with a value at Week 52 and at Week 76 for the parameter of interest were analyzed. One participant did not have P1NP measured.||percent change|||Number
766512|NCT00679939|Secondary|Adjusted Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) and Procollagen Type 1 N-propeptide (P1NP) at Week 52 and Week 76|BSAP and P1NP levels were measured in micrograms per liter (mcg/L) from blood samples. BSAP and P1NP are indicators of bone buildup or formation. GM, geometric mean; SE, standard error. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region.|Baseline, Week 52, and Week 76|Safety Population. Only evaluable participants with a value at Baseline and at Week 52 or Week 76 for the parameter of interest were analyzed.||percent change|||Number
766513|NCT00679939|Secondary|Adjusted Percent Change in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA From Week 52+30 Days to Week 76 + 30 Days|BMD (measured in grams per centimeters squared [g/cm^2]) was measured by DXA. Percent change from Week 52 + 30 days to Week 76 + 30 days was calculated as (BMD at Week 76 + 30 days minus BMD at Week 52 + 30 days)/BMD at Week 52 + 30 days x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.|Week 52 + 30 days and Week 76 + 30 days|Safety Population. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET and Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed. Not all participants had correct positioning for all of the DXA measurements.||percent change||Standard Error|Mean
766514|NCT00679939|Secondary|Adjusted Percent Change in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA From Week 52+10 Days to Week 76 + 10 Days|BMD (measured in grams per centimeters squared [g/cm^2]) was measured by DXA. Percent change from Week 52 + 10 days toat Week 76 + 10 days was calculated as (BMD at Week 76 + 10 days minus BMD at Week 52 + 10 days)/BMD at Week 52 + 10 days x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.|Week 52 + 10 days and Week 76 + 10 days|Safety Population. Only evaluable participants with a value at Week 52 performed up to 10 days after initiating OL MET and at Week 76 performed up to 10 days after stopping OL MET for the parameter of interest were analyzed. Not all participants had correct positioning for the DXA lumbar spine measurement.||percent change||Standard Error|Mean
766515|NCT00679939|Secondary|Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA at Week 52|BMD (measured in grams per centimeters squared [g/cm^2]) was measured by DXA. Percent change from Baseline at Week 52 was calculated as (BMD at Week 52 minus BMD at Baseline)/BMD at Baseline x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.|Baseline and Week 52|Safety Population. Only evaluable participants with a value at baseline and at Week 52 for the parameter of interest were analyzed. Only participants with Baseline DXA and Week 52 DXA measurements performed on or prior to initiating open-label MET were analyzed. Not all participants had correct positioning for the DXA lumbar spine measurement.||percent change||Standard Error|Mean
766516|NCT00679939|Primary|Adjusted Percent Change in Femoral Neck (FN) Bone Mineral Density (BMD) Via Dual-energy X-ray Absorptiometry (DXA) From Week 52 +10 Days to Week 76+10 Days|FN BMD (measured in grams per centimeters squared [g/cm^2]) was measured by DXA. Bone mineral density is calculated as the mineral content of a bone divided by the area of the bone. DXA is the principal technique used for measuring BMD. Percent change from Week 52+10 days to Week 76+10 days was calculated as (BMD at Week 76+10 days minus BMD at Week 52+10 days)/BMD at Week 52+10 days x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.|Week 52+10 days and Week 76+10 days|Safety Population. Only evaluable participants with a value at Week 52 performed up to 10 days after initiating OL MET and at Week 76 performed up to 10 days after stopping OL MET for the parameter of interest were analyzed.||percent change||Standard Error|Mean
766517|NCT00679939|Primary|Adjusted Percent Change From Baseline in Femoral Neck (FN) Bone Mineral Density (BMD) Via Dual-energy X-ray Absorptiometry (DXA) at Week 76+10 Days|FN BMD (measured in grams per centimeters squared [g/cm^2]) was measured by DXA. Bone mineral density is calculated as the mineral content of a bone divided by the area of the bone. DXA is the principal technique used for measuring BMD. Percent change from Baseline at Week 76+10 days was calculated as (BMD at Week 76+10 days minus BMD at Baseline)/BMD at Baseline x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.|Baseline and Week 76+10 days|Safety Population. Only evaluable participants with a value at baseline and at Week 76 performed up to 10 days after stopping OL MET for the parameter of interest were analyzed.||percent change||Standard Error|Mean
766518|NCT00679939|Primary|Adjusted Percent Change From Baseline in Femoral Neck (FN) Bone Mineral Density (BMD) Via Dual-energy X-ray Absorptiometry (DXA) at Week 52|FN BMD (measured in grams per centimeters squared [g/cm^2]) was measured by DXA. Bone mineral density is calculated as the mineral content of a bone divided by the area of the bone. DXA is the principal technique used for measuring BMD. Percent change from Baseline at Week 52 was calculated as (BMD at Week 52 minus BMD at Baseline)/BMD at Baseline x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Change in FN BMD at Week 52 was only analyzed within the Rosiglitazone arm.|Baseline and Week 52|Safety Population. Only evaluable participants with a value at baseline and at Week 52 for the parameter of interest were analyzed. Only participants with Baseline DXA and Week 52 DXA measurements performed on or prior to initiating open-label MET are included in this primary analysis.||percent change||Standard Error|Mean
766519|NCT00679952|Secondary|Severity of Pancreatic Fistulas||2 years||||||
766520|NCT00679952|Primary|Number of Patients With Pancreatic Fistula|"pancreatic fistula rate is stratified according to ISGPF criteria.
Grade A; No major impact Grade B; Clinically relevant fistula, specific treatment may be required Grade C; Most severe form of fistula, with a high mortality rate"|postoperative 1 week|||participants|||Number
766521|NCT00680017|Secondary|Mean Percent Change in High-Density Lipoprotein Cholesterol From Baseline to Week 8.|High-density lipoprotein cholesterol (HDL-C) was measured in milligrams/deciliter (mg/dL).|Baseline to 8 weeks|Full Analysis Set was used and was defined as all randomized participants who had both a baseline value and at least 1 postbaseline value for HDL-C. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.||percent change||Standard Error|Least Squares Mean
766522|NCT00680017|Primary|Median Percent Change in Triglycerides From Baseline to Week 8.|Triglycerides were measured in milligrams/deciliter.|Baseline to 8 weeks|Full Analysis Set was used and was defined as all randomized participants who had both a baseline value and at least 1 postbaseline value for triglycerides. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.||percent change||Inter-Quartile Range|Median
766523|NCT00680043|Secondary|Proportion of Participants Achieving Hemoglobin Response During the Correction and Evaluation Periods|A hemoglobin response is defined as a hemoglobin increase of ≥ 1.0 g/dL above baseline and a hemoglobin ≥ 11.0 g/dL without RBC or whole blood transfusion during the previous 8 weeks.|Weeks 1 to 28|Full Analysis Population||percentage of participants|||Number
766524|NCT00680043|Secondary|Proportion of Participants Who Receive Red Blood Cell (RBC) or Whole Blood Transfusions During the Correction and Evaluation Periods||Weeks 1 to 28|Full Analysis Population||percentage of participants|||Number
766525|NCT00680043|Primary|Mean Change in Hemoglobin Between Baseline and the Evaluation Period|The baseline hemoglobin value is defined as the mean of the two most recent hemoglobin values taken prior to the day of randomization plus the value obtained on the day of randomization prior to Dose 1. The mean hemoglobin during the Evaluation period for each participant is calculated as the mean of the available hemoglobin values during Study Weeks 21 through 28.|Baseline and Weeks 21-28|Full Analysis Population||g/dL||Standard Deviation|Mean
766526|NCT00680056|Secondary|Mean Score on the Transitional Dyspnea Index (TDI)|TDI is a multidimensional clinical instrument developed to provide a comprehensive assessment of change in dyspnea after an intervention, considering three components (functional impairment, magnitude of task, and magnitude of effort). It ranges from -9 (major deterioration) to +9 (major improvement).|After 2 week of each treatment|||score on scale||Standard Deviation|Mean
766527|NCT00680056|Primary|Percentage Change in Exercise Tolerance From Baseline at 2 Weeks|Percentage change from baseline in time to the limit of tolerance on a high intensity constant-speed treadmill exercise test (with a speed corresponding to 80% of that obtained during incremental test)|Baseline and after 2 weeks with each treatment|The specific period where the patient received a given treatment were analysed together.||Percentage change||Standard Error|Mean
766528|NCT00680121|Secondary|Symptom Checklist-90 (SCL-90): Global Severity Index|The SCL-90 is a brief multidimensional self-report inventory that screens for nine symptoms of psychopathology and provides three global distress indicators. It provides an overview of symptom severity and intensity. The outcome measures psychiatric symptoms using a 30-item scale reported as t-scores relative to a normative population.|6 Months|||t-score||Standard Deviation|Mean
766529|NCT00680121|Secondary|Barrett Impulsivity Scale: Total Impulsiveness|Scale measures impulsiveness. It includes 30 items that are scored to yield six first-order factors (attention, motor, self-control, cognitive complexity, perseverance, and cognitive instability impulsiveness) and three second-order factors (attentional, motor, and non-planning impulsiveness). Items are scored on a 4 point scale with 1 point equaling rarely/never up to 4 points equaling almost always/always. Total impulsivity score ranges from 30 (least impulsive) to 120 (most impulsive). The higher the score the higher the level of impulsiveness.|6 Months|||scores on a scale||Standard Deviation|Mean
766530|NCT00680121|Secondary|Alcoholism Severity Scale|The alcoholism severity scale measures the severity of a person's dependence to alcohol. The scale ranges from a score of 0 (least severe) to 33 (most severe). The higher the score the worse the dependence.|6 Months|||scores on a scale||Standard Deviation|Mean
766531|NCT00680121|Primary|Change in Average Daily Alcohol Consumption|measured as standard drinks of alcohol per day (SD/day)|Change from Baseline to 6 Months|||alcoholic drinks per day||Standard Deviation|Mean
766532|NCT00680186|Secondary|Laboratory Analyses|Frequency of patients with possible clinically significant abnormalities.|From first intake of study drug to last intake of study drug + 6 days washout|TS||participants|||Number
766533|NCT00680186|Secondary|Number of Participants With Acute Coronary Syndrome (ACS)|Any ACS occurring during the conduct of the study (centrally adjudicated as definite). Patients having a centrally adjudicated definite ACS during intake of study drug and after stopping study drug, according to treatment group. ACS assessments pre-specified in the protocol without adjudication. Prior to database lock, the steering committee asked to have ACS events adjudicated by an independent committee. After database lock, the committee was provided with source documentation that was blinded to the patient's treatment assignment. ACS results presented are based on adjudication findings.|From first intake of study drug to last contact date|TS||participants|||Number
766534|NCT00680186|Secondary|Number of Participants With MBE, MBE and/or CRBE, and Any Bleeding Events|"Major bleeding events (MBE) are defined as
Fatal bleeding
Symptomatic bleeding in a critical area or organ
Bleeding causing a fall in haemoglobin level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of 2 or more units of whole blood or red cells
Clinically-relevant bleeding events (CRBE) are defined as
spontaneous skin hematoma >=25 cm²
wound hematoma >=100 cm²
spontaneous nose bleed >5 min
macroscopic hematuria spontaneous or >24 hours if associated with an intervention
spontaneous rectal bleeding
gingival bleeding >5 min
leading to hospitalisation and / or requiring surgical treatment
leading to a transfusion of <2 units of whole blood or red cells
any other bleeding event considered clinically relevant by the investigator
Any bleeding events were defined as major, clinically-relevant and nuisance bleeding events. Nuisance bleeding events were defined as all other bleeding events that did not fulfil the criteria from above."|From first intake of study drug to last intake of study drug + 6 days washout|Treated set (TS): consisted of all randomised patients who were documented to have taken at least one dose of study drug. Patients were assigned to the treatment groups as treated.||participants|||Number
766535|NCT00680186|Secondary|Number of Participants With Recurrent Symptomatic Fatal and Non-fatal PE|Symptomatic fatal and non-fatal PE which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.|For statistical analysis 1: from randomisation to 6 months (up to day 180). For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.|FAS||participants|||Number
766536|NCT00680186|Secondary|Number of Participants Who Died (Any Cause)|Any deaths which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.|For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.|FAS||participants|||Number
766537|NCT00680186|Secondary|Number of Participants Who Died Due to VTE|VTE - related deaths which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee. Hazard ratios and 95% CI were not calculated because of insufficient number of events.|From randomisation to 6 months (up to day 180) and to end of ptp (planned to be up to day 224)|FAS||participants|||Number
766538|NCT00680186|Secondary|Number of Participants With Recurrent Symptomatic Non-fatal PE|Symptomatic non-fatal PE which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.|For statistical analysis 1: from randomisation to 6 months (up to day 180). For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.|FAS||participants|||Number
766539|NCT00680186|Secondary|Number of Participants With Recurrent Symptomatic DVT|Symptomatic DVT which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.|For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.|FAS||participants|||Number
766540|NCT00680186|Secondary|Number of Participants With Recurrent Symptomatic VTE and All Deaths|VTE or any death which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.|For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.|FAS||participants|||Number
766541|NCT00680186|Primary|Number of Participants With Recurrent Symptomatic Venous Thromboembolism (VTE) and Deaths Related to VTE|All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.|For statistical analysis 1: from randomisation to end of post treatment period (ptp), planned to be up to day 224. For statistical analysis 2: from randomisation to 6 months (up to day 180)|Full analysis set (FAS): consisted of all randomised patients who were documented to have taken at least one dose of study drug. Patients were assigned to the treatment groups as randomised, i.e. regardless of the actual medication taken.||participants|||Number
766542|NCT00680225|Secondary|Visual Acuity Changes||12 mo|PI has left the institution and summary data are not available.|||||
766543|NCT00680225|Primary|Mean Tumor Thickness||12 mo|||mm||Full Range|Mean
766544|NCT00680316|Secondary|Change in Respiratory Symptom Domain Score From the Cystic Fibrosis Questionnaire Revised (CFQ-R) for Parents of Preschoolers and for Preschoolers|"The CFQ-R for Preschoolers and the CFQ-R for Parents of Preschoolers was designed specifically to measure the impact of CF for patients with a diagnosis of CF. Each question is answered using a 4-point Likert scale.
In order to calculate the domain/symptom scale scores, the following algorithm is followed
Re-number items which have been reverse coded
Calculate the mean of the items to be included. If more than half of the items are missing, then the score is considered missing
Re-scale to result in a scaled score which ranges from 0 to 100, with higher scores indicating better health"|from Visit 2 to Visit 3 (16 +/- 2 days)|Children were unable to perform forced oscillometry (FOT) or did not remain stable during the study. No efficacy analyses were performed because no patients had complete (pre- or post-treatment) data for pulmonary function tests, including FOT.|||||
766545|NCT00680316|Secondary|Change in Resistance at 4, 6, 8, and 10 Hz (Rrs4, Rrs6, Rrs8, and Rrs10)|The fundamental principle of forced oscillometry is that lung function can be assessed by measuring changes in pressure and flow in response to external pressure applied at the airway opening. Resistance is complex measure that incorporates the lack of changes in pressure and volume and the rate of these changes in response to pressure oscillations at a specific frequency. (10Hz was used for the secondary endpoint).|from Visit 2 to Visit 3 (16 +/- 2 days)|Children were unable to perform forced oscillometry (FOT) or did not remain stable during the study. No efficacy analyses were performed because no patients had complete (pre- or post-treatment) data for pulmonary function tests, including FOT.|||||
766546|NCT00680316|Secondary|Change in Reactance at 4, 6, and 10 Hz (Xrs4, Xrs6, and Xrs10)|The fundamental principle of forced oscillometry is that lung function can be assessed by measuring changes in pressure and flow in response to external pressure applied at the airway opening. Reactance is complex measure that incorporates the changes in pressure and volume and the rate of these changes in response to pressure oscillations at a specific frequency. (8Hz was used for the primary endpoint). Reactance is thought to reflect the elastic properties of the lung.|from Visit 2 to Visit 3 (16 +/- 2 days)|Children were unable to perform forced oscillometry (FOT) or did not remain stable during the study. No efficacy analyses were performed because no patients had complete (pre- or post-treatment) data for pulmonary function tests, including FOT.|||||
766547|NCT00680316|Primary|Change in Reactance at 8 Hz (Xrs8) From Visit 2 to Visit 3 (Change From Baseline at Visit 2 to Visit 3, After Study Drug Treatment).|The fundamental principle of forced oscillometry is that lung function can be assessed by measuring changes in pressure and flow in response to external pressure applied at the airway opening. Reactance is complex measure that incorporates the changes in pressure and volume and the rate of these changes in response to pressure oscillations at a specific frequency. (8Hz was used for the primary endpoint). Reactance is thought to reflect the elastic properties of the lung.|from Visit 2 to Visit 3 (16 +/- 2 days)|Children were unable to perform forced oscillometry (FOT) or did not remain stable during the study. No efficacy analyses were performed because no patients had complete (pre- or post-treatment) data for pulmonary function tests, including FOT.|||||
766548|NCT00680368|Secondary|Intraclass Correlation Coefficient for Test-retest Reliability for Attending Physicians|Assesses the test-retest reliability among repeated responses to surveys administered to attending physicians only.|24 hours|||Intraclass Correlation Coefficient||95% Confidence Interval|Number
766549|NCT00680368|Secondary|Intraclass Correlation Coefficient Assessing Test-retest Reliability for Resident Physicians|Assesses the test-retest reliability of repeated responses for resident physicians only to report the total time spent during resident supervision.|24 hours|||Intraclass Correlation Coefficient||95% Confidence Interval|Number
766550|NCT00680368|Primary|Intraclass Correlation Coefficient Between Physician Resident and Attending Physician.|Describes agreement between physician resident and attending physician assessment of total resident supervision time for a given patient and patient care clinical encounter.|24-hours|||Intraclass Correlation Coefficient||95% Confidence Interval|Number
766551|NCT00680407|Post-Hoc|Efficacy - Improvement by at Least 2 Points in Histology (NAS) - With NAS Without Cirrhosis|This outcome measure excludes the substantial percentage (62.8%) of patients with baseline biopsies that were deemed ineligible (per inclusion criteria) by the central pathologist due to NAS <4 or absence of NASH (nonalcoholic steatohepatitis) (n=34), NASH with presence of cirrhosis (n=1), or slides unavailable/not evaluable for reading (n=14).|48-50 week treatment period|Subgroup of ITT (Intent to Treat) Patients with NASH and without cirrhosis population||participants|||Number
766552|NCT00680407|Secondary|Safety - Occurrence of a Dose-limiting Toxicity||48-50 week treatment period|||participants|||Number
766553|NCT00680407|Primary|Efficacy - Improvement by at Least 2 Points in Histology (NAS)||48-50 week treatment period|||participants|||Number
766554|NCT00680459|Secondary|Recurrence of Central Venous Line Infection Within 35 Days of Enrollment||35 days|||# of pts with recurrent infection|||Number
766555|NCT00680459|Secondary|Preservation of Central Venous Line (Line Not Requiring Removal) by Day 35 of Study||35 days|||number of lines preserved|||Number
766556|NCT00680459|Primary|Clearance of Central Venous Line Infection by Day 6 of Study||6 days|||number of CVL cleared|||Number
766557|NCT00680524|Primary|Acceptability to Providers and Patients|Patients and providers rated the components of the intervention on a 5 point scale where 1 = poor and 5 = excellent and average ratings for each group is reported below|Six months|||units on a scale||Standard Deviation|Mean
766558|NCT00680628|Primary|Number With Recurrent Venous Thromboembolism and/or Severe Post-phlebitic Syndrome||90 days|||participants|||Number
766559|NCT00680628|Primary|Number With Functional Cardiopulmonary Limitations Assessed With a Composite Measurement (Six Minute Walk Distance, Right Ventricular Function and Quality of Life Score on the SF-36)||90 days|||participants|||Number
766560|NCT00680628|Primary|Number of Patients With Cardiogenic Shock or Respiratory Failure From Pulmonary Embolism and Number of Patietnts With Major Hemorrhage||1,2,3,4, and 5 days|||participants|||Number
766561|NCT00680706|Primary|Effect of Thiamine Supplementation on Dyspnea|Sitting Upright on Oxygen. Measured using a 10-centimeter visual analog scale (VAS). Measures are in units of millimeters (mm). A smaller number should be interpreted as a less dyspnea. A larger number should be interpreted as a more dyspnea. Less dyspnea is a better clinical outcome than more dyspnea.|8-Hour|||mm||95% Confidence Interval|Mean
766562|NCT00680706|Primary|Effect of Thiamine Supplementation on Dyspnea|Sitting Upright on Oxygen. Measured using a 10-centimeter visual analog scale (VAS). Measures are in units of millimeters (mm). A smaller number should be interpreted as a less dyspnea. A larger number should be interpreted as a more dyspnea. Less dyspnea is a better clinical outcome than more dyspnea.|Baseline|||mm||95% Confidence Interval|Mean
766563|NCT00680745|Secondary|Adjusted Mean Change in Fasting Plasma Glucose (FPG)|To show that dapagliflozin plus glimepiride leads to greater reductions in FPG after 24 weeks of treatment compared to placebo plus glimepiride.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values||mg/dL||95% Confidence Interval|Least Squares Mean
766643|NCT00687531|Secondary|Number of Participants With One or More Mild, Moderate or Severe Asthma Exacerbations|Exacerbation severity will be characterized based on exacerbation classification from the Global Initiative for Asthma (GINA) workshop 2005 and the National Heart Lung and Blood Institute (NHLBI) asthma guidelines.|Day 1 and Week 12|This analysis was not performed due to missing data at the sites.|||||
766564|NCT00680745|Secondary|Adjusted Mean Change in Body Weight for Participants With Baseline Body Mass Index (BMI)≥27 kg/m2|To show that dapagliflozin plus glimepiride results in greater reductions in body weight or less weight gain in participants with baseline BMI ≥27 kg/m2 after 24 weeks of treatment when compared to placebo plus glimepiride.|Baseline to Week 24|Full Analysis Set, participants with baseline BMI of 27 kg/m2 or more and Week 24 (LOCF) body weight value||kg||95% Confidence Interval|Least Squares Mean
766565|NCT00680745|Secondary|Proportion of Participants Achieving Glycemic Response Defined as HbA1c <7%|To show that dapagliflozin plus glimepiride results in a larger proportion of participants achieving a therapeutic glycemic response, defined as HbA1c < 7% after 24 weeks of treatment, compared to placebo plus glimepiride.|At Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values||Percentage of participants||95% Confidence Interval|Least Squares Mean
766566|NCT00680745|Secondary|Adjusted Mean Change in 2-h Post-challenge Plasma Glucose Rise|To show that dapagliflozin plus glimepiride results in greater reductions in the 2-h post-challenge plasma glucose rise as a response to an oral glucose tolerance test (OGTT) from baseline to Week 24.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values||mg/dL||95% Confidence Interval|Least Squares Mean
766567|NCT00680745|Secondary|Adjusted Mean Change in Body Weight|To show that dapagliflozin plus glimepiride results in greater reduction in body weight or less weight gain after 24 weeks of treatment when compared to placebo plus glimepiride.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values||kg||95% Confidence Interval|Least Squares Mean
766568|NCT00680745|Primary|Adjusted Mean Change in HbA1c Levels|To assess the efficacy of dapagliflozin compared to placebo as add-on therapy to glimepiride in improving glycemic control in participants with type 2 diabetes, as determined by the change in HbA1C levels from baseline to the end of the 24-week double-blind treatment period.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values||Percent||95% Confidence Interval|Least Squares Mean
766569|NCT00680771|Primary|Positive Antibody Response|Sero-Response to the Hepatitis B vaccine, defined as reaching or exceeding a Hepatitis B surface antigen level of greater than or equal to 10mIU/mL.|3 Months after initial vaccination|From subjects with complete data only.||participants|||Number
766570|NCT00680797|Primary|Insulin Sensitivity|As measured by change in insulin levels pre- and post-hormone changes|6 weeks|Two participants had missing values post-intervention therefore number of participants analyzed total 31.||micro International Units/mL||Standard Deviation|Mean
766571|NCT00680836|Secondary|Change in Bloating|Bloating is measured on a scale from 0 to 4; 0 = no bloating to 4 = severe bloating. Change in bloating is calculated from baseline to post treatment.|2 weeks|||units on a scale||95% Confidence Interval|Mean
766572|NCT00680836|Secondary|Change in Abdominal Pain With Bowel Movement|Severity of abdominal pain on a scale of 0 to 4 was measured; 0 meaning no pain to 4 meaning severe pain. Change in abdominal pain from baseline to post treatment was calculated.|2 weeks|||units on a scale||95% Confidence Interval|Mean
766573|NCT00680836|Secondary|Change in Bowel Urgency|Urgency in a bowel movements compared from baseline to post treatment was measured. Participants were asked to note if they had urgency at bowel movements (meaning if they had to rush to the restroom). They marked either 'yes' or 'no'. The percentage of the time they said yes was calculated for 7 days. The difference between baseline and post treatment urgency was calculated.|2 weeks|||difference in percentage of 'Yes'||95% Confidence Interval|Mean
766574|NCT00680836|Secondary|Change in Stool Consistency|Change in Stool consistency from baseline to post treatment is measured. Bristol stool scale is used for this purpose. The scale ranges from a value of 1- 7; 1 being very hard stool to 7 being liquid stools. The change is measured for 1 week post-treatment and the average consistency is used for the purpose of measuring change from baseline.|2 weeks|||units on a scale (BSS)||95% Confidence Interval|Mean
766575|NCT00680836|Secondary|Change in Stool Frequency (Number of Bowel Movements Per Day)|Change in stool frequency (number of bowel movements per day) compared from baseline to post treatment is measured. Number of bowel movements per day before treatment is subtracted from the number of bowel movements per day after treatment. The change in frequency has been reported in the outcomes table.|2 weeks|||Bowel movements/ day||95% Confidence Interval|Mean
766576|NCT00680836|Primary|Global Improvement Scale|Improvement in Irritable Bowel Syndrome symptoms post treatment is measured. This scale is not measured at baseline. Participants are asked if their symptoms improved or got worse and to rate it on a scale of 1- 7 for seven days. Average score for 7 days is calculated. The Global improvement scale ranges from 1- 7. Score of 1-3 means the IBS symptoms got worse, 4 means no change and 5-7 means improvement in the IBS symptoms.|Measured for seven days at the end of 2 weeks treatment and average score is calculated|||units on a scale||Standard Deviation|Mean
766577|NCT00680862|Primary|Number of Participants Who Completed the Survey|survey responses from participants on thoughts pertaining to implementation of HIV rapid testing|6 months|||participants|||Number
766578|NCT00680901|Secondary|Number of Participants With a Worst-case on Therapy Grade 3 or Grade 4 for the Indicated Hematology Parameters|Data are summarized by NCI CTCAE, version 3.0 toxicity grades. Data are reported as the number of participants who had a Grade 3 (G3) or Grade 4 (G4) toxicity for indicated hematology parameters: G3 indicates a severe toxicity, and G4 indicates a life-threatening toxicity. Hematology parameter included: Hemoglobin (Hemo), Total Neutrophils (TN) Absolute, Platelet Count (PC), and White Blood Cell (WBC) Count.|From Baseline (Day 1) until 28 days after the last dose (average of 239 days)|"Safety Population. Different participants may have been assessed for different parameters; thus the number of participants analyzed reflects everyone in the Safety Population. The number of participants assessed for each parameter is indicated by n=X, X."||Participants|||Number
766598|NCT00680914|Secondary|Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes|The results were presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. In this assay the cut-off value for opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A was defined as >= 8.|One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.||subjects|||Number
772189|NCT00732940|Secondary|Absolute Change From Baseline in IgM at Week 24||Baseline, 24 Weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.||g/L||Standard Error|Mean
766579|NCT00680901|Secondary|Number of Participants With a Worst-case on Therapy Grade 3 or Grade 4 for the Indicated Clinical Chemistry Parameters|Data are summarized by NCI CTCAE, version 3.0 toxicity grades. Data are reported as the number of participants who had a Grade 3 (G3) or Grade 4 (G4) toxicity for the indicated clinical chemistry parameters: G3 indicates a severe toxicity, and G4 indicates a life-threatening toxicity. Clinical chemistry parameters included: Albumin, Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transeferase (AST), Total Bilirubin (TB), Calcium (Hypercalcemia and Hypocalcemia), Creatine Kinase (CK), Creatinine, Glucose (Hyperglycemia [high] and Hypoglycemia [low]), Potassium (Hyperkalemia [high] and Hypokalemia [low]), Magnesium (Hypermagnesemia [high] and Hypomagnesemia [low]), and Sodium (Hypernatremia [high] and Hyponatremia [low]).|From Baseline (Day 1) until 28 days after the last dose (average of 239 days)|"Safety Population. Different participants may have been assessed for different parameters; thus the number of participants analyzed reflects everyone in the Safety Population. The number of participants assessed for each parameter is indicated by n=X, X."||Participants|||Number
766580|NCT00680901|Secondary|Mean Change in Scores on the Questionnaire EuroQoL-5 Dimensions (EQ-5D) From Baseline to Week 36|The EQ-5D is a generic preference-based HROOL self administered tool comprising of a 5-dimensional health status measure (5D utility measure) and a visual analog rating scale feeling thermometer (T.). 5D utility measures mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. T. assesses participant’s current health state. Each 5D utility question was responded to on a 3-point scale, indicating the level of impairment (1=no problem; 2=some or moderate problem(s); 3=unable, or extreme problems). The index utility values corresponding to the 243 health states were defined by the EuroQol classification and calculated based on country-specific regression coefficients. In the UK-based value set, the possible EQ-5D index utility values range from –0.594 to 1. The T. value ranges from 0 to 100. EQ-5D utility index score 0=death, 1=perfect health, -0.594 = worse than death. The T. score: 100=best imaginable health state, 0=worse imaginable health state.|From Baseline (Day1) to Week 36|Primary Efficacy Population. Only those participants contributing data at the indicated time point were analyzed.||Scores on a scale||Standard Deviation|Mean
766581|NCT00680901|Secondary|Mean Change in Scores on the EORTC Quality of Life (QOL) Questionnaire of Stomach 22 (QLQ-STO22) From Baseline to Week 36|The EORTC QLQ-STO22, the Gastric module of QLQ-C30, is a self administered tool use to assess HROOL of patients with gastric cancer. It consists of 22 items consisting of nine symptom scales or single items (dysphagia, pain, reflux, eating restrictions, anxiety, dry mouth, taste, body image, hair loss) that were developed for participants with gastric cancer. For the symptom scales or single items, participants assessed using a 4-point scale (1=not at all; 2=a little; 3=quite a bit; 4=very much). All scales and single-item scores ranged from 0 to 100. For the symptom scales or single items, a higher score indicated a high level of symptoms and problems, i.e. 0=no symptoms, 100=most severe symptoms.|From Baseline (Day1) to Week 36|Primary Efficacy Population. Only those participants contributing data at the indicated time point were analyzed.||Scores on a scale||Standard Deviation|Mean
766582|NCT00680901|Secondary|Mean Change in Scores on the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QOL) Questionnaire Core 30 (QLQ-C30) From Baseline to Week 36|The QLQ-C30, a self administered tool used to assess HROL, consists of 30 items that assesses 15 domains consisting of 5 functional scales (s.) (physical, role, emotional, cognitive, social) and nine symptom s. or single items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties) and a global health status or QOL s.. For the functional s. and symptom s. or single items, participants assessed using a 4-point s. (1=not at all; 2=a little; 3=quite a bit; 4=very much), whereas global health status or QOL was assessed using a 7-item Likert s., ranging from “poor” to “excellent.” All s. and single-item scores ranged from 0 to 100. For the functional scores, a higher score indicated a better HRQOL, i.e. 0=worst HRQOL, 100=best HRQOL; for the symptom s. or single items , a higher score indicated a high level of symptoms and problems, i.e. 0=no symptoms, 100=most severe symptoms.|From Baseline (Day1) to Week 36|Primary Efficacy Population. Only those participants contributing data at the indicated time point were analyzed.||Scores on a scale||Standard Deviation|Mean
766583|NCT00680901|Secondary|Number of Participants With Adverse Events of the Indicated Severity, Per the National Cancer Institute (NCI) Common Terminology Criteria in Adverse Events (CTCAE)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. AE/SAE severity was graded according to NCI CTCAE, version 3.0: Grade (G) 1, mild; G2, moderate; G3, severe; G4, life threatening; G5, death related to toxicity.|From the first dose of study medication until 30 days after the last dose (average of 229 days)|Safety Population||Participants|||Number
766584|NCT00680901|Secondary|Number of Participants With Any Non-serious Adverse Event (AE: Occurring in >=5% Participants in Any Treatment Arm) or Any Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.|From the first dose of study medication until 30 days after the last dose (average of 229 days)|Safety Population: all randomized participants who received at least one dose of study medication||Participants|||Number
766599|NCT00680914|Secondary|Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes|Concentration of cross-reactive pneumococcal serotypes 6A and 19A in ug/mL.|One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.||ug/mL||95% Confidence Interval|Geometric Mean
766585|NCT00680901|Secondary|Duration of Response (DOR)|DOR is defined as the time from the first documented evidence of a CR (the disappearance of all target and non-target lesions) or PR (at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD) until the first documented sign of PD or death due to any cause. Per RECIST, PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started or the appearance of >=1 new lesion. Participants who had neither progressed nor died were censored at the follow-up visit as either follow-up ended or follow-up ongoing. Participants who received non-study anti-cancer therapies before disease progression were treated as censored.|From the time of the first documented evidence of a confirmed CR or PR until the earliest date of disease progression or death due to any cause (average of 36 weeks)|Primary Efficacy Population. Only those participants who had a confirmed CR or PR were analyzed for duration of response.||Months||95% Confidence Interval|Median
766586|NCT00680901|Secondary|Time to Response (TTR)|TTR is defined as the time from randomization until the date of the first documented evidence of CR (the disappearance if all target and non-target lesions) or PR (at least a 30% decrease in the sum of the LD of target lesions, taking a reference the Baseline sum LD) as assessed by the investigator.|From Baseline (Day 1) until the first documented evidence of confirmed CR or PR (average of 9 weeks)|Primary Efficacy Population. Only those participants who had a confirmed CR or PR were analyzed for duration of response.||Months||95% Confidence Interval|Median
766587|NCT00680901|Secondary|Number of Participants With Clinical Benefit (CB)|CB is defined as evidence of a CR (disappearance of all target and non-target lesions) or PR (at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD) at any time or stable disease (SD, neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started) as assessed by the investigator.|From randomization until disease progression (PD) or death due to any cause (average of 30 weeks)|Primary Efficacy Population||Participants|||Number
766588|NCT00680901|Secondary|Number of Participants With a Response of Confirmed Complete Response (CR) or Confirmed Partial Response (PR)|A participant was defined as a responder if he/she achieved either a CR (the disappearance of all target and non-target lesions) or a PR (at least a 30% decrease in the sum of the longest diameters [LD] of target lesions, taking as a reference the Baseline sum LD) as assessed by the investigator (confirmed by radiographic imaging within 4 weeks from initial observations).|From randomization until the date of the first documented response of CR or PR (average of 9 weeks)|Primary Efficacy Population||Participants|||Number
766589|NCT00680901|Secondary|Progression Free Survival (PFS)|PFS is defined as the interval between the date of randomization and the earliest date of disease progression (PD) or death due to any cause. Per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started or the appearance of >= 1 new lesion. Participants who did not have a radiological assessed PD but had symptomatic PD were also counted. Participants who had neither progressed nor died were censored at the follow-up visit as either follow-up ended or follow-up ongoing. Participants who received non-study anti-cancer therapies before disease progression were treated as censored.|From randomization until the earliest date of disease progression or death due to any cause (average of 30 weeks)|Primary Efficacy Population||months||95% Confidence Interval|Median
766590|NCT00680901|Primary|Overall Survival in All Randomized Participants|Overall Survival is defined as the time from randomization until death due to any cause. Participants who had not died were censored at the follow-up visit as either follow-up ended or follow-up ongoing.|From randomization until death due to any cause (average of 51 weeks)|Intent-to-Treat (ITT) Population: all participants randomized to study treatment, regardless of whether they actually received study medication.||months||95% Confidence Interval|Median
766591|NCT00680901|Primary|Overall Survival|Overall Survival is defined as the time from randomization until death due to any cause. Participants who had not died were censored at the follow-up visit as either follow-up ended or follow-up ongoing.|From randomization until death due to any cause (average of 51 weeks)|Primary Efficacy Population: all randomized participants with Human Epidermal Growth Factor Receptor 2 (ErbB2)-positive tumors (based on Fluorescence In Situ Hybridization [FISH]-positive designated central laboratory assessment).||months||95% Confidence Interval|Median
766592|NCT00680914|Secondary|Number of Subjects With Serious Adverse Events (SAE)|"An SAE is any untoward medical occurrence that:
results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above."|Following the administration of the first dose of the study vaccines throughout the entire study period up to study month 5|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.||subjects|||Number
766593|NCT00680914|Secondary|Number of Subjects Reporting Unsolicited Adverse Events||Within 31 days after each vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.||subjects|||Number
766594|NCT00680914|Secondary|Number of Subjects With Solicited General Symptoms|"Solicited general symptoms assessed include drowsiness, fever, irritability and loss of appetite.
Fever was defined as axillary temperature >= 37.5 degrees Celsius."|Within 4 days after each vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.||subjects|||Number
766595|NCT00680914|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling.|Within 4 days after each vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.||subjects|||Number
766596|NCT00680914|Secondary|Number of Subjects With Seroprotection Status Against PRP|Seroprotection status is defined as anti-PRP antibody concentrations above 0.15 ug/mL and above 1.0 ug/mL|One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.||subjects|||Number
766597|NCT00680914|Secondary|Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations|Concentration of anti-PRP antibody given as GMC in ug/mL.|One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.||ug/mL||95% Confidence Interval|Geometric Mean
766601|NCT00680914|Secondary|Antibody Concentrations Against Pneumococal Serotypes Contained in the Vaccine|Concentrations are reported as Geometric Mean Concentrations in ug/mL. Pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.|One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.||ug/mL||95% Confidence Interval|Geometric Mean
766602|NCT00680914|Secondary|Number of Subjects With Cross-reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value|"Anti-pneumococcal antibody cut-off value assessed was 0.20 microgram per milliliter (ug/mL).
Pneumococcal cross-reactive serotypes were 6A and 19A."|One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.||subjects|||Number
766603|NCT00680914|Secondary|Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes Contained in the Vaccine Above the Cut-off Value|"The results were presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. In this assay the cut-off value for opsonophagocytic activity against pneumococcal antibody assessed was >= 8.
The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F."|One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.||subjects|||Number
766604|NCT00680914|Secondary|Number of Subjects With a Seropositivity Status Against Protein D and Defined Pneumococcal Serotypes|"Seropositivity status for protein D is defined as anti protein D (anti-PD) antibody concentrations >= 100 Enzyme-Linked Immuno Sorbent Assay (EL) units EL.U/mL.
Seropositivity status for pneumococcal serotypes is defined as anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations >= 0.05 ug/mL."|One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.||subjects|||Number
766605|NCT00680914|Primary|Number of Subjects With Vaccine Pneumococcal Serotypes Antibody Concentrations Above the Cut-Off Value|"Anti-pneumococcal antibody cut-off value assessed was 0.20 microgram per milliliter (ug/mL).
The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F."|One month after administration of 3rd dose of the pneumococcal conjugate vaccine|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.||subjects|||Number
766606|NCT00680953|Secondary|Percentage of Participants With Hip Fractures in Osteoporotic Participants Treated With Denosumab Compared to Treatment With Placebo.|The results are expressed as a percentage by Kaplan-Meier estimate.|Baseline to 24 Months|||percentage of participants|||Number
766607|NCT00680953|Secondary|The Percentage of Non-vertebral Fractures|The results are expressed as percentage by Kaplan-Meier estimate the percentage of participants with non-vertebral fractures|Baseline to 24 Months|||percentage of participants||95% Confidence Interval|Number
766608|NCT00680953|Primary|Incidence of New or Worsening Vertebral Fractures in Osteoporotic Subjects Treated With Denosumab Compared to Placebo||Baseline to 24 months|||Vertebral fractures||95% Confidence Interval|Mean
766609|NCT00681031|Primary|Geometric Mean Titre (GMT) of Varicella Antibodies|Blood samples to determine the GMT of varicella antibodies taken pre-vaccination and again 28 to 35 days post vaccination. Titres determined by glycoprotein enzyme-linked immunosorbent assay (gpELISA).|Predose (Day 0) and Day 28-35 Post Dose|All vaccinated participants excluding those with any protocol deviation which may have interfered with the immunogenicity evaluation and excluding participants with herpes zoster onset before the post-vaccination blood sample||gpELISA units/mL||95% Confidence Interval|Geometric Mean
766610|NCT00681044|Secondary|Tolerability||100 days|No data were collected or analyzed due to study termination|||||
766611|NCT00681044|Secondary|Overall Survival||life|No data were collected or analyzed due to study termination|||||
766612|NCT00681044|Secondary|Organ or Clinical Response||One year|No data were collected or analyzed due to study termination|||||
766613|NCT00681044|Secondary|Predictability of Early Free Light-chain Response for Heme Response||One month|No data were collected or analyzed due to study termination|||||
766614|NCT00681044|Primary|Hematologic Response Rate||one year|No data were collected or analyzed due to study termination|||||
766644|NCT00687531|Secondary|Patient’s Assessment of Response to Therapy Based on a 5-point Scale|A scale of 1 to 5 will be used with 1 being much improved (AM and PM symptom severety/frequency improve >75% from baseline) and 5 being much worse (AM and PM symptom severity/frequency got more than 75% worse from baseline).|Baseline, Week 12|This analysis was not performed due to missing data at the sites.|||||
766624|NCT00681187|Secondary|Healthcare Professionals With Positive Response to Specified Questions on Self or Partner Administration Method|"Assessed by the number of HCP with a positive response 'yes' to two questions:
Based on your experience during this trial, did you feel confident in the safety of your patients?
Based on your experience during this trial, would you recommend suitable patients to try self or partner administration?"|Between week 30 to 34|One HCP from each site who enrolled participants replied to the question||participants|||Number
766625|NCT00681187|Secondary|5-hydroxyindoleacetic Acid (5-HIAA) Levels|"Biochemical control was assessed by analysing 5-HIAA levels at each site visit, which was judged as necessary by the investigator at each site.
'Before self or partner administration' was assessed at baseline for group 1 and at week 12 for group 2.
'After self or partner administration' was assessed at week 16 to 20 for group 1 and at week 12 for group 2.
'Before HCP administration' was assessed at week 16 to 20 for group 1 and at baseline for group 2.
'After HCP administration' was assessed at week 30 to 34 for group 1 and week 12 for group 2."|Group 1 - Baseline, week 16 to 20 and 30 to 34. Group 2 - Baseline, week 12 and 30 to 34.|5-HIAA were assessed as judged necessary by the investigator at each site.||nmol/l||Standard Deviation|Mean
766626|NCT00681187|Secondary|Chromogranin A Levels|"Biochemical control was assessed by analysing chromogranin A levels at each site visit, which was mandatory for all subjects.
'Before self or partner administration' was assessed at baseline for group 1 and at week 12 for group 2.
'After self or partner administration' was assessed at week 16 to 20 for group 1 and at week 12 for group 2.
'Before HCP administration' was assessed at week 16 to 20 for group 1 and at baseline for group 2.
'After HCP administration' was assessed at week 30 to 34 for group 1 and week 12 for group 2."|Group 1 - Baseline, week 16 to 20 and 30 to 34. Group 2 - Baseline, week 12 and 30 to 34.|ITT population that had hormone levels assessed at each administration block.||nmol/l||Standard Deviation|Mean
766627|NCT00681187|Secondary|Perceived Symptom Control Evaluation in Respect to Episodes of Diarrhoea|Participants were asked how they perceived the symptoms in respect to episodes of diarrhoea since the last injection. Participants included in the study were previously treated with lanreotide autogel and therefore the assessment at baseline was made in comparison to previous injection outside of the study protocol.|Group 1 - baseline, week 16 to 20 (self or partner administration) and week 30 to 34 (HCP administration). Group 2 - baseline, week 12 to 16 (HCP administration) and week 30 to 34 (self or partner administration).|Analysis was performed on Intention to Treat population defined as all randomised subjects with ≥ 1 dose of study medication and with a preference assessment recorded.||participants|||Number
766628|NCT00681187|Secondary|Perceived Symptom Control Evaluation in Respect to Episodes of Flushing|Participants were asked how they perceived the symptoms in respect to episodes of flushing since the last injection. Participants included in the study were previously treated with lanreotide Autogel and therefore the assessment at baseline was made in comparison to their previous injection outside of the study protocol.|Group 1 - baseline, week 16 to 20 (self or partner administration) and week 30 to 34 (HCP administration). Group 2 - baseline, week 12 (HCP administration) and week 30 (self or partner administration).|Analysis was performed on Intention to Treat population defined as all randomised subjects with ≥ 1 dose of study medication and with a preference assessment recorded.||participants|||Number
766629|NCT00681187|Secondary|Total Number of Visits to HCP Due to Carcinoid Symptoms|Health care and patient costs associated with the treatment of carcinoid symptoms in subjects treated with lanreotide Autogel were assessed by recording the total number of visits made by participants (n=12) to HCP due to carcinoid symptoms.|Group 1 - between week 8 to 20 (self or partner administration), between week 20 to 32 (HCP administration). Group 2 - between week 20 to 32 (self or partner administration), between week 0 to week 12 (HCP administration)|Safety population: all randomised subjects with at least one dose of study medication||visits|||Number
766630|NCT00681187|Secondary|Days Sick Leave|Health care and patient costs associated with the treatment of carcinoid symptoms in subjects treated with lanreotide Autogel were assessed through recording loss of production for subject through total number of days sick leave of the employed patients (n=6).|Group 1 - between week 8 to 20 (self or partner administration), between week 20 to 32 (HCP administration). Group 2 - between week 20 to 32 (self or partner administration), between week 0 to week 12 (HCP administration)|Safety population: all randomised subjects with at least one dose of study medication. Two of the six subjects reported sick leave during the study. One subject was absent for one day due to unknown reason, the other was absent for 22 days due to surgery of metastasis.||days|||Number
766631|NCT00681187|Secondary|Number of Patients Stating at Least One Injection Negatively Interfered With Psychological Wellbeing|The subject was asked: 'Does the treatment administration used today negatively interfere with your psychological wellbeing?'|Between baseline to week 32, after each injection (8-9 injections)|Analysis was performed on Intention to Treat population defined as all randomised subjects with ≥ 1 dose of study medication and with a preference assessment recorded||participants|||Number
766632|NCT00681187|Secondary|Number of Patients Stating at Least One Injection Interfered With Daily Activities|The subject was asked: 'Does the treatment administration used today interfere with your daily activities?'|Between baseline to week 32, after each injection (8-9 injections)|Analysis was performed on Intention to Treat population defined as all randomised subjects with ≥ 1 dose of study medication and with a preference assessment recorded||Participants|||Number
766633|NCT00681187|Primary|Subject Preference for Self or Partner Administration|A global question was asked: 'If you could choose, which administration method would you like to use on a regular basis?' A) Healthcare professional provided injection B) Self/ partner administered injection|Between week 30 to 34|Analysis was performed on Intention to Treat population defined as all randomised subjects with ≥ 1 dose of study medication and with a preference assessment recorded||participants|||Number
766634|NCT00687453|Secondary|Any Adverse Event Other Than Hypoglycemia||6 months||||||
766635|NCT00687453|Secondary|Total Daily Insulin Dose||6 months||||||
766636|NCT00687453|Secondary|Body Mass Index Change From Baseline||6 months||||||
766637|NCT00687453|Secondary|Frequency of Severe Hypoglycemic Reactions||6 months||||||
766638|NCT00687453|Secondary|Frequency of Total Hypoglycemic Reactions||6 months||||||
766639|NCT00687453|Secondary|Frequency of Pre-supper Glucose Readings 120 mg/dL or Less||6 months||||||
766640|NCT00687453|Primary|Hemoglobin A1c Change From Baseline||Baseline to 6 months|ITT (LOCF)||Percent||Standard Deviation|Mean
766671|NCT00687674|Secondary|Plasma Cell Gene Expression Profiles and Correlation With > Clinical Outcomes||Post treatment||||||
766645|NCT00687531|Secondary|Investigator’s Assessment of Response to Therapy Based on a 5-point Scale|The investigator will assess the subject's response to therapy by interviewing the subject and comparing the current level of symptoms from baseline. A scale of 1 to 5 will be used with 1 being much improved (AM and PM symptom severety/frequency improve >75% from baseline) and 5 being much worse (AM and PM symptom severity/frequency got more than 75% worse from baseline).|Baseline, Week 12|This analysis was not performed due to missing data at the sites.|||||
766646|NCT00687531|Secondary|Number of Puffs of Salbutamol Used Daily||Day 1 and Week 12|This analysis was not performed due to missing data at the sites.|||||
766647|NCT00687531|Secondary|Number of Nocturnal Awakenings||Day 1 and Week 12|This analysis was not performed due to missing data at the sites.|||||
766648|NCT00687531|Secondary|Morning and Evening Asthma Symptoms Based on a 3 Point Scale (4 Individual Symptoms) and 24 Points (Summed).|The symptoms of cough, chest tightness, wheezing, and shortness of breath were each to be graded on a scale of 0 to 3 with 0 being no symptoms present and 3 being very marked symptoms which was disturbing most of the time. Scores were to have been recorded at 12AM and 12PM for a total of 24 points summed.|Day 1 and Week 12|This analysis was not performed due to missing data at the sites.|||||
766649|NCT00687531|Secondary|Number of Items in the Asthma Quality of Life (QOL) Questionnaire and the General QOL Questionnaire That Had a Significant (Positive) Change From Baseline to Endpoint|"Questionnaires consisted of items such as General Health Condition (excellent/very good/good/regular/bad), Difficulty to Breathe (always/almost always/considerable part of time/partially/few amount of time/almost never/never), General Asthma Limitations (completely/a lot/enough to be considered/regular/a few/almost nothing/nothing), etc...
The questionnaires together consisted of 44 questions, each question with categorical variables as response. A Friedman test was performed to determine the significance of change in samples from baseline to endpoint, for each question."|Day 1 and Week 12|study completers (per protocol population)||questions|questions||Number
766650|NCT00687531|Secondary|Morning (AM) and Evening (PM) Peak Expiratory Flow Rate (PEFR)|Participants were to record their daily AM and PM PEFR values in a diary. PEFR can be measured using a peak flow meter that was given to the participant. Normal readings are based on a person's gender, age, and height. A reading of 80 to 100% of the usual or normal peak flow readings indicate that the asthma is under good control. Increased PEFR indicates improvement in asthma control.|Day 1 and Week 12|study completers (per protocol population)||Liters/minute||Standard Deviation|Mean
766651|NCT00687531|Primary|Forced Expiratory Volume in 1 Second (FEV1)|Spirometry was performed to measure FEV1, which is the amount of air the participant is able to exhale in 1 second. Normal values for FEV1 in healthy people depend on age and gender, but values between 80% and 120% of the normal value is considered good. Increased FEV1 indicates improvement in asthma control.|Day 1 and Week 12|study completers (per protocol population)||Liters||Standard Deviation|Mean
766652|NCT00687544|Secondary|Number of Participants Experiencing Adverse Events|An adverse event was defined as any untoward medical occurrence in a subject administered a pharmaceutical product, biologic (at any dose), or medical device, which did not necessarily have a causal relationship with the treatment.|Throughout the study (up to 72 weeks)|||participants|||Number
766653|NCT00687544|Secondary|Number of Participants Who Died||Throughout the study (up to 72 weeks)|||participants|||Number
766654|NCT00687544|Primary|Number of Participants Who Achieved Sustained Biochemical Response (SBR)|"Treatment duration for genotype 1 participants was 48 weeks. Treatment duration for genotypes 2 & 3 participants who had baseline hepatitis c virus ribonucleic acid [HCV-RNA] <800,000 IU/mL was 24 weeks.
SBR was defined as the presence of normal alanine aminotransferase (ALT) values at the end of 24 weeks follow-up (week 48 or 72).
The study was terminated due to low enrollment. This analysis was not performed."|Week 48 or Week 72 (depending on duration of treatment, which was either 24 or 48 weeks)||||||
766655|NCT00687544|Secondary|Number of Participants Experiencing Opportunistic Infection|The study was terminated due to low enrollment. This analysis was not performed.|Throughout the study (up to 72 weeks)||||||
766656|NCT00687544|Primary|Number of Participants Who Achieved Virologic Response (VR)|"Treatment duration for genotype 1 participants was 48 weeks. Treatment duration for genotypes 2 & 3 participants who had baseline hepatitis c virus ribonucleic acid [HCV-RNA] <800,000 IU/mL was 24 weeks.
The study was terminated due to low enrollment. This analysis was not performed."|24 Weeks or 48 Weeks (depending on duration of treatment, which was either 24 or 48 weeks)||||||
766657|NCT00687544|Primary|Number of Participants Who Achieved Sustained Virologic Response (SVR)|"Treatment duration for genotype 1 participants was 48 weeks. Treatment duration for genotypes 2 & 3 participants who had baseline hepatitis c virus ribonucleic acid [HCV-RNA] <800,000 IU/mL was 24 weeks.
SVR was defined as plasma HCV RNA level below lower level of quanitation at the end of 24 weeks follow-up (week 48 or 72).
The study was terminated due to low enrollment. This analysis was not performed."|Week 48 or Week 72 (depending on duration of treatment)||||||
766658|NCT00687609|Secondary|C-SSRS Intensity of Ideation (Most Common Ideation Type and Most Severe Ideation Type) By Visit at Week 4|Participants rate most common and most severe ideation type by frequency (1=<once per week/5=many times/day), duration (1=fleeting/5=>8 times per hour persistent, continuous), controllability (1=easily able to control thoughts/8=no attempt), deterrents to active attempts (1=deterrent definitely stopped you/8=N/A, wish to die only), and reason for ideation (1=completely for attention/revenge/reaction/5=completely to stop the pain). Only items with yes responses at a given week are listed. A participant could have a yes response in more than one item.|Week 4|It was planned to use the full analysis set (FAS) for the efficacy and safety analyses, which included data from all participants who received at least one dose of atomoxetine and had at least one post-baseline assessment.||Participants|||Number
766659|NCT00687609|Secondary|C-SSRS Suicidal Ideation By Visit at Week 4: Non-Specific Active Suicidal Thoughts|Solicits suicide-related information with structured questioning. Scale consists of 28 items in 4 sections: suicide behavior, actual attempts, suicidal ideation, intensity of ideation. Suicidal ideation consists of 5 yes/no items: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intention to act, active suicidal ideation with some intent to act without specific plan, active suicidal ideation with specific plan and intent. Only items with yes responses at a given week are listed.|Week 4|It was planned to use the full analysis set (FAS) for the efficacy and safety analyses, which included data from all participants who received at least one dose of atomoxetine and had at least one post-baseline assessment.||Participants|||Number
766660|NCT00687609|Secondary|Change From Baseline in Neurocognitive Functioning as Measured at 12 Weeks by a Test Battery: Time Reproduction Task|For the Time Reproduction Task participants need to reproduce the duration of a visual stimulus (lightbulb) by pressing a button. The intervals vary between 2 – 20 seconds. The performance of this task takes about 15 minutes.|Baseline, 12 weeks|It was planned to use the full analysis set (FAS) for the efficacy and safety analyses, which included data from all participants who received at least one dose of atomoxetine and had at least one post-baseline assessment.||Milliseconds||Standard Deviation|Mean
766661|NCT00687609|Secondary|Change From Baseline in Neurocognitive Functioning as Measured at 12 Weeks by a Test Battery: Contingency Task|For the Contingency Task participants estimate the duration of a time interval of 1 second by pushing a button. Responses that are within a dynamic time interval are being classified as correct. This way, 50 % of the responses are correct, 50% incorrect. Three contingency conditions: neutral, reward and response cost. The performance of this task takes about 15 minutes.|Baseline, 12 weeks|It was planned to use the full analysis set (FAS) for the efficacy and safety analyses, which included data from all participants who received at least one dose of atomoxetine and had at least one post-baseline assessment.||Milliseconds||Standard Deviation|Mean
766662|NCT00687609|Secondary|Change From Baseline in Neurocognitive Functioning as Measured at 12 Weeks by a Test Battery: Stop-Signal Task|Consists of 2 types of trials: go trials and stop trials. Go trials require participants to locate the position of an aircraft displayed to the left or right of a fixation point on a computer screen by pressing a left or right button. In 25% of the go stimili an additional stop stimulus (auditory signal) is presented shortly after the go stimulus. Participant then needs to inhibit their response. By varying the time period between go and stop stimulus, 50% of the trials are inhibited successfully, 50% not. The latency of inhibition is estimated. This task takes about 25 minutes.|Baseline, 12 weeks|It was planned to use the full analysis set (FAS) for the efficacy and safety analyses, which included data from all participants who received at least one dose of atomoxetine and had at least one post-baseline assessment.||Milliseconds||Standard Deviation|Mean
766663|NCT00687609|Secondary|Change From Baseline to 12 Weeks in the Marijuana Craving Questionnaire (MCQ)|The MCQ is a 12-item self-rated questionnaire to assess cannabis craving with 4 factors: compulsivity (an inability to control marijuana use), emotionality (use of marijuana in anticipation of relief from withdrawal/negative mood), expectancy (anticipation of positive outcomes from smoking marijuana) and purposefulness (intention and planning to use marijuana for positive outcomes). Scores are calculated on a 7-point scale (1=strongly disagree; 7=strongly agree). A separate score is calculated for each factor; scores range from 3-21 each with higher scores indicating greater craving.|Baseline, 12 weeks|It was planned to use the full analysis set (FAS) for the efficacy and safety analyses, which included data from all participants who received at least one dose of atomoxetine and had at least one post-baseline assessment.||Units on a scale||Standard Deviation|Mean
766664|NCT00687609|Secondary|Change From Baseline to 12 Weeks in the Pediatric Anxiety Rating Scale (PARS)|The Pediatric Anxiety Rating Scale (PARS) is used to rate the severity of anxiety in children and adolescents, ages 6 to 17 years. The total score for the PARS is derived by summing 5 of the 7 severity/impairment/interference items (2,3,5,6,7). The total score ranges from 0 (none) to 25 (extreme severity). Items 1 (overall number of anxiety symptoms) and 4 (overall severity of physical symptoms) are not included in the total score calculation.|Baseline, 12 weeks|It was planned to use the full analysis set (FAS) for the efficacy and safety analyses, which included data from all participants who received at least one dose of atomoxetine and had at least one post-baseline assessment.||Units on a scale||Standard Deviation|Mean
766665|NCT00687609|Secondary|Change From Baseline to 12 Weeks in the Children's Depression Rating Scale-Revised (CDRS-R)|Measures presence and severity of depression. Consists of 17 items scored on a 1-5 or 1-7 scale (1 = no symptom difficulties; 5 or 7 = severe clinically significant difficulties) A rating of 1 indicates normal, thus the minimum score is 17. The maximum score is 113. In general, scores below 20 indicate an absence of depression; scores of 20 or 30 indicate borderline depression; scores of 40 to 60 indicate moderate depression.|Baseline, 12 weeks|It was planned to use the full analysis set (FAS) for the efficacy and safety analyses, which included data from all participants who received at least one dose of atomoxetine and had at least one post-baseline assessment.||Units on a scale||Standard Deviation|Mean
766666|NCT00687609|Secondary|Change From Baseline to 12 Weeks in Global Impression of Perceived Difficulties (GIPD) - Participant Rated Version|The Global Impression of Perceived Difficulties (GIPD) scale is a five-item rating of ADHD-related difficulties. For each item, difficulties during the past week are rated on a 7 point scale (1=normal, not difficult at all; 7= extremely difficult). The GIPD total score is the sum of all subscores (items) and ranges from 5 to 35. Higher scores indicate greater impairment. The scale is completed by the participant.|Baseline, 12 weeks|It was planned to use the full analysis set (FAS) for the efficacy and safety analyses, which included data from all participants who received at least one dose of atomoxetine and had at least one post-baseline assessment.||Units on a scale||Standard Deviation|Mean
766667|NCT00687609|Secondary|Clinical Global Impression-ADHD-Improvement (CGI-ADHD-I) at 12 Weeks|Measures total improvement (or worsening) of a patient's ADHD symptoms from the beginning of treatment. (1=very much improved, 7=very much worsened)|12 weeks|It was planned to use the full analysis set (FAS) for the efficacy and safety analyses, which included data from all participants who received at least one dose of atomoxetine and had at least one post-baseline assessment.||Units on a scale||Standard Deviation|Mean
766668|NCT00687609|Primary|Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale-IV-Parent Version: Investigator Scored Total Score at 12 Weeks|Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. Higher scores indicate greater impairment. The scale is scored by an investigator while interviewing the parent.|12 weeks|It was planned to use the full analysis set (FAS) for the efficacy and safety analyses, which included data from all participants who received at least one dose of atomoxetine and had at least one post-baseline assessment.||Units on a scale||Standard Deviation|Mean
766669|NCT00687674|Secondary|Change in VEGF Expression Levels and Correlation With Clinical Outcomes (Phase II)||Post treatment||||||
766670|NCT00687674|Secondary|Percentage of Stained Circulating Endothelial Cells and Endothelial Progenitor Cells and Correlation With Clinical Outcomes (Phase II||Post treatment||||||
766674|NCT00687674|Secondary|Time to Disease Progression (Phase II)|"Time to disease progression (TTP) was defined as the time from registration to progression. The median TTP with 95%CI was estimated using the Kaplan Meier method.
Progression was defined as any one or more of the following:
An increase of 25% from lowest confirmed response in:
Serum M-component (absolute increase >= 0.5g/dl)
Urine M-component (absolute increase >= 200mg/24hour
Difference between involved and uninvolved Free Light Chain levels (absolute increase >= 10mg/dl
Bone marrow plasma cell percentage (absolute increase of >=10%)"|From registration to progression (up to 3 years)|No participants proceeded to Phase II for evaluation.||months||95% Confidence Interval|Median
766675|NCT00687674|Secondary|Overall Survival (Phase II)|Overall Survival (OS) was defined as the time from registration to death of any cause. Participants were followed for a maximum of 2 years from registration. The median OS with 95%CI was estimated using the Kaplan Meier method|From registration to death (up to 3 years)|No participants proceeded to Phase II for evaluation.||months||95% Confidence Interval|Median
766676|NCT00687674|Primary|Number of Participants Who Achieve a Confirmed Response (Partial Response [PR], Very Good PR [VGPR], Complete Response [CR], or Stringent CR [sCR]) (Phase II)|"Response that was confirmed on 2 consecutive evaluations during treatment
CR: Complete disappearance of M-protein from serum & urine on immunofixation, <5% plasma cells in bone marrow (BM)
sCR: CR plus normal FLC ratio & absence of clonal cells in BM
VGPR: >=90% reduction in serum M-component; Urine M-Component <100 mg per 24 hours; <=5% plasma cells in BM
PR: >= 50% reduction in serum M-Component and/or Urine M-Component >= 90% reduction or <200 mg per 24 hours; or >= 50% decrease in difference between involved and uninvolved FLC levels"|Duration on Treatment (up to 3 years)|No participants proceeded to Phase II for evaluation.||Participants|||Number
766677|NCT00687674|Primary|Number of Participants With a Grade 3 and 4 Adverse Event (Phase I)|"Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.
Description of Grades:
Grade 1: Mild Grade 2: Moderate Grade 3: Severe Grade 4: Life-threatening Grade 5: Death"|up to 3 years|One participant refused further treatment prior to being assessed for adverse events.||participants|||Number
766678|NCT00687713|Secondary|Treatment Success Among Subjects With 18 or Less Days of Methamphetamine Use|The study population for this outcome measure is defined as those participants with methamphetamine dependence who report using methamphetamine 18 or less days during the 30 days prior to signing consent.|30 days|||Participants|||Count of Participants
766679|NCT00687713|Primary|Number of Subjects Showing Abstinence|The primary efficacy outcome measure was a measurement of treatment success or failure, where a subject who successfully achieved two weeks of abstinence during the last two weeks of investigational product dosing (Weeks 11 and 12) was scored as a success.|Weeks 11 and 12|||Participants|||Count of Participants
766680|NCT00687804|Secondary|Extension Study: Mean Change From Core Study Baseline in Best Corrected Visual Acuity (BCVA) at Month 36|Visual acuity (VA) was assessed on both eyes during every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. An increase in the number of letters read correctly indicates improvement.|Core baseline (Day 1 of the core study), Month 36 (end of extension study)|Safety Population included all participants who entered the extension and who had at least one safety assessment in the extension study. Participants were grouped according to the treatment assigned in the Core study.||Letters||Standard Deviation|Mean
766681|NCT00687804|Secondary|Extension Study: Mean Change From Extension Study Baseline in Best Corrected Visual Acuity (BCVA) at Month 36|Visual acuity (VA) was assessed on both eyes during every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. An increase in the number of letters read correctly indicates improvement.|Extension baseline (Month12 -end of core study), Month 36 (end of extension study)|Participants from the Safety Population that included all participants who entered the extension and who had at least one safety assessment in the extension study with data available for analyses. Participants were grouped according to the treatment assigned in the Core study.||Letters||Standard Deviation|Mean
766682|NCT00687804|Primary|Extension Study: Percentage of Participants With Non-Ocular Adverse Events (AEs) in the 24 Month Extension Study|"Participants with non-ocular (not occurring in the eye) serious adverse events (SAEs) and non-serious AEs. AEs are the appearance or worsening of of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. A serious adverse event is defined as an event that is fatal or life-threatening, results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, requires inpatient hospitalization or prolongation of existing hospitalization or is medically significant.
Additional information about adverse events can be found in the Adverse Event section."|Extension baseline (Month 12 -end of core study) to Month 36 (end of extension study) [24 Months]|Safety Population included all participants who entered the extension and who had at least one safety assessment in the extension study. Participants were grouped according to the treatment assigned in the Core study.||Percentage of participants|||Number
766683|NCT00687804|Secondary|Extension Study: Percentage of Participants With Non-Ocular Adverse Events (AEs) in the 36 Months of the Core and Extension Studies|"Participants with non-ocular (not occurring in the eye) serious adverse events (SAEs) and non-serious AEs. AEs are the appearance or worsening of of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. A serious adverse event is defined as an event that is fatal or life-threatening, results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, requires inpatient hospitalization or prolongation of existing hospitalization or is medically significant.
Additional information about Adverse Events can be found in the Adverse Event section."|Core baseline (Day 1 of the core study) to Month 36 (end of extension study) [36 Months]|Safety Population included all participants who entered the extension and who had at least one safety assessment in the extension study. Participants were grouped according to the treatment assigned in the Core study.||Percentage of participants|||Number
770373|NCT00711009|Secondary|Mean Change From Baseline in Fasting Glucose (Millimoles/Liter)|Included in measures of metabolic toxicity|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||millimoles/liter||Standard Deviation|Mean
766684|NCT00687804|Secondary|Extension Study: Percentage of Participants With Ocular Adverse Events (AEs) in the Study Eye in the 36 Months of the Core and Extension Studies|"Participants with ocular (occurring in the eye) serious adverse events (SAEs) and non-serious AEs in the study eye. The study eye is the eye that received the treatment. AEs are the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. A serious adverse event is defined as an event that is fatal or life-threatening, results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, requires inpatient hospitalization or prolongation of existing hospitalization or is medically significant.
Additional information about adverse events can be found in the Adverse Event section."|Core baseline (Day 1 of the core study) to Month 36 (end of extension study) [36 months]|Safety Population included all participants who entered the extension and who had at least one safety assessment in the extension study. Participants were grouped according to the treatment assigned in the Core study.||Percentage of participants|||Number
766685|NCT00687804|Primary|Extension Study: Percentage of Participants With Ocular Adverse Events (AEs) in the Study Eye in the 24 Month Extension Study|"Participants with ocular (occurring in the eye) serious adverse events (SAEs) and non-serious AEs in the study eye. The study eye is the eye that received the treatment. AEs are the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. A serious adverse event is defined as an event that is fatal or life-threatening, results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, requires inpatient hospitalization or prolongation of existing hospitalization or is medically significant.
Additional information about adverse events can be found in the Adverse Event section."|Extension baseline (Month 12 -end of core study) to Month 36 (end of extension study) [24 Months]|Safety Population included all participants who entered the extension and who had at least one safety assessment in the extension study. Participants were grouped according to the treatment assigned in the Core study.||Percentage of participants|||Number
766686|NCT00687804|Secondary|Core Study: Mean Change From Baseline in Patient-reported Visual Functioning|The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) was used to measure a patient’s subjective assessment of vision-related quality of life. The 12 subscales in the VFQ-25 are general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. The scores on the subscales were added together for a total score, which ranged from 0 to 100. A higher score indicated improvement in quality of life due to vision function.|Baseline to Month 12|The number analyzed is the Full Analysis Set, including the number of patients with a value at both baseline and the Month 12 visit. Last Observation Carried Forward imputation was utilized.||Units on a scale||Standard Deviation|Mean
766687|NCT00687804|Secondary|Core Study: Mean Change From Baseline at Month 12 in Central Retinal Thickness of the Study Eye|Retinal thickness was measured using Optical Coherence Tomography (OCT). The images were reviewed by a central reading center to ensure a standardized evaluation.|Baseline to Month 12|The number analyzed is the Full Analysis Set, including patients with a value at both baseline and the Month 12 visit. Last Observation Carried Forward imputation was utilized.||Micrometers||Standard Deviation|Mean
766688|NCT00687804|Secondary|Core Study: Mean Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time|Visual acuity (VA) was assessed on both eyes during every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters.|Baseline to Month 12|Full analysis set, utilizing last observation carried forward.||Letters||Standard Error|Mean
766689|NCT00687804|Secondary|Core Study: Categorized Change in Visual Acuity (Letters) of the Study Eye From Baseline at Month 12|Visual acuity (VA) was assessed on both eyes during every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters.|Baseline to Month 12|Full analysis set consists of all patients who received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent to treat principle, patients were analyzed according to the treatment assigned. Last Observation Carried Forward (LOCF) imputation was utilized.||Participants|||Number
766690|NCT00687804|Primary|Core Study: Difference Between the Baseline Level of Visual Acuity (Letters) of the Study Eye and the Mean Visual Acuity Averaged Over All Monthly Post-baseline Assessments From Month 1 to Month 12|Visual acuity (VA) was assessed on both eyes during every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters.|Baseline through the end of study (Month 12)|Full analysis set consists of all patients who received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent to treat principle, patients were analyzed according to the treatment assigned. Last Observation Carried Forward (LOCF) imputation was utilized.||Letters||Standard Deviation|Mean
766691|NCT00688467|Secondary|Number of Participants Discontinued From the Study Because of an Adverse Event|An AE is any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to study drug. Discontinuations due to an AE are reported based on the study drug taken at the time of the event.|Up to 48 days|The population analyzed included all participants who received study drug||Participants|||Number
766692|NCT00688467|Secondary|Number of Participants With an Adverse Event (AE)|An AE is any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to study drug. AEs were reported based on the study drug taken at the time of the event.|Up to 48 days|The population analyzed included all participants who received study drug||Participants|||Number
767445|NCT00696020|Secondary|Tmax,ss Tiotropium [h]|Time from last dosing to maximum concentration of Tiotropium in plasma at steady state (tmax,ss) after 4 weeks of treatment.|Pre-dose, 5 min, 10 min, 20 min, 40 min, 1 h, 3 h, and 6 h after the last dose.|Evaluable patients.||hours||Full Range|Median
766693|NCT00688467|Secondary|Change From Baseline in Sputum Eosinophil Cationic Protein (ECP) Level After Allergen Challenge Following 9 Days Pretreatment With Navarixin|Induced sputum samples were to be collected via the nebulized method. ECP level was measured in the sputum supernatant.|Baseline and 7 and 24 hours after allergen challenge|ECP level was not analyzed because too few evaluable samples were collected|||||
766694|NCT00688467|Secondary|Change From Baseline in Sputum Myeloperoxidase (MPO) Level After Allergen Challenge Following 9 Days Pretreatment With Navarixin|Induced sputum samples were to be collected via the nebulized method. MPO level was measured in the sputum supernatant.|Baseline and 7 and 24 hours after allergen challenge|MPO level was not analyzed because too few evaluable samples were collected|||||
766695|NCT00688467|Secondary|Change From Baseline in Sputum Neutrophil Elastase After Allergen Challenge Following 9 Days Pretreatment With Navarixin|Induced sputum samples were to be collected via the nebulized method. Neutrophil elastase activity was measured in the sputum supernatant as milli units/mL (mU/mL). Baseline values were determined at 24 hours before allergen challenge in each treatment period. The reported SDs are pooled across all treatment groups. The rationale for the use of an analysis of variance using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline and 7 and 24 hours after allergen challenge|The population analyzed included all participants who completed both treatment periods and were able to produce evaluable sputum samples||mU/mL||Standard Deviation|Least Squares Mean
766696|NCT00688467|Secondary|Change From Baseline in Sputum Interleukin 8 (IL-8) After Allergen Challenge Following 9 Days Pretreatment With Navarixin|Induced sputum samples were to be collected via the nebulized method. IL-8 level was measured in the sputum supernatant. Baseline values were determined at 24 hours before allergen challenge in each treatment period. The reported SDs are pooled across all treatment groups. The rationale for the use of an analysis of variance using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline and 7 and 24 hours after allergen challenge|The population analyzed included all participants who completed both treatment periods and were able to produce evaluable sputum samples||pg/mL||Standard Deviation|Least Squares Mean
766697|NCT00688467|Secondary|Change From Baseline in Peripheral Blood Eosinophil Count After Allergen Challenge Following 9 Days Pretreatment With Navarixin|Baseline values were determined at 24 hours before allergen challenge in each treatment period. The reported SDs are pooled across all treatment groups. The rationale for the use of an analysis of variance using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline and 7 and 24 hours after allergen challenge|The population analyzed included all participants who completed both treatment periods and had evaluable blood samples available||Percent change from baseline||Standard Deviation|Least Squares Mean
766698|NCT00688467|Secondary|Change From Baseline in Sputum Neutrophils After Allergen Challenge Following 9 Days Pretreatment With Navarixin|Induced sputum samples were collected via the nebulized method. Baseline values were determined at 24 hours before allergen challenge in each treatment period. Sputum neutrophils were measured as percent of total white blood cells. The reported SDs are pooled across all treatment groups. The rationale for the use of an analysis of variance using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline and 7 and 24 hours after allergen challenge|The population analyzed included all participants who completed both treatment periods and were able to produce evaluable sputum samples||Percent change from baseline||Standard Deviation|Least Squares Mean
766699|NCT00688467|Secondary|Maximum Percent Change From Baseline in FEV1 During the Early Asthmatic Response Following 9 Days of Pretreatment With Navarixin|Allergen challenge was administered 1 hour after the ninth daily dose of study drug in each treatment period. The EAR was 0 to 2 hours after allergen challenge. The reported SDs are pooled across all treatment groups. The rationale for the use of an analysis of variance using pooled SD values is the assumption that the SDs are similar across treatment groups. The pooled SD values were used in the calculation of test statistics to assess treatment differences (p-value generation).|Baseline and between 0 to 2 hours after allergen challenge|The population analyzed included all participants who completed both treatment periods||Percent change from baseline||Standard Deviation|Least Squares Mean
766700|NCT00688467|Secondary|Percent Change From Baseline in FEV1 Area Under the Curve From 0 to 2 Hours (AUC0-2hr) After Allergen Challenge Following 9 Days Pretreatment With Navarixin|This is a measure of Early Asthmatic Response (EAR) between 0 to 2 hours after allergen challenge. Allergen challenge was administered 1 hour after the ninth daily dose of study drug in each treatment period. A percent change >0 indicates a reduction in FEV1 from before to after allergen challenge. The reported SDs are pooled across all treatment groups. The rationale for the use of an analysis of variance using pooled SD values is the assumption that the SDs are similar across treatment groups. The pooled SD values were used in the calculation of test statistics to assess treatment differences (p-value generation).|Baseline and between 0 to 2 hours after allergen challenge|The population analyzed included all participants who completed both treatment periods||Percent change from baseline||Standard Deviation|Least Squares Mean
766701|NCT00688467|Secondary|Change in Concentration of Methacholine That Initiated a 20% Reduction in FEV1 From 24 Hours Before (Baseline) to 24 Hours After Allergen Challenge|This is a measure of allergen-induced changes in airway responsiveness to methacholine. The reported SDs are pooled across all treatment groups. The rationale for the use of an analysis of variance using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline and 24 hours after allergen challenge|The population analyzed included all participants who completed both treatment periods||Log methacholine (mg/mL)||Standard Deviation|Least Squares Mean
766702|NCT00688467|Secondary|Maximum Change From Baseline in FEV1 During the LAR Following 9 Days of Pretreatment With Navarixin|Allergen challenge was administered 1 hour after the ninth daily dose of study drug in each treatment period. Baseline FEV1 was defined as the prechallenge FEV1 in the treatment period. The LAR was 3 to 7 hours after allergen challenge. The reported SDs are pooled across all treatment groups. The rationale for the use of an analysis of variance using pooled SD values is the assumption that the SDs are similar across treatment groups. The pooled SD values were used in the calculation of test statistics to assess treatment differences (p-value generation).|Baseline and between 3 and 7 hours after allergen challenge|The population analyzed included all participants who completed both treatment periods||Liters||Standard Deviation|Least Squares Mean
770374|NCT00711009|Secondary|Mean Change From Baseline in Calculated Creatinine Clearance (Milliliters/Second)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||milliliters/second||Standard Deviation|Mean
766703|NCT00688467|Primary|Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve From 3 to 7 Hours (AUC3-7hr) After Allergen Challenge Following 9 Days Pretreatment With Navarixin|This is a measure of the Late Asthmatic Response (LAR) between 3 and 7 hours after allergen challenge. Allergen challenge was administered 1 hour after the ninth daily dose of study drug in each treatment period. Baseline FEV1 was defined as the prechallenge FEV1 in the treatment period. A percent change >0 indicates a fall in FEV1 after allergen challenge. The reported standard deviations (SDs) are pooled across all treatment groups. The rationale for the use of an analysis of variance using pooled SD values is the assumption that the SDs are similar across treatment groups. The pooled SD values were used in the calculation of test statistics to assess treatment differences (p-value generation).|Baseline and between 3 and 7 hours after allergen challenge|The population analyzed included all participants who completed both treatment periods||Percent change from baseline||Standard Deviation|Least Squares Mean
766704|NCT00688519|Secondary|Number of Subjects Who Have Treatment Success at Week 8 Analyzed by Baseline ISGA (Mild or Moderate)|Assessment (on a scale of 0 to 4) was made as a visual average of all lesions, except those on the face/scalp. 0=clear; minor residual discoloration; no erythema/scaling/plaque thickness (PT). 1=almost clear; occasional fine scale/faint erythema/barely perceptible PT. 2=mild; fine scales predominate; light red coloration/mild PT. 3=moderate; coarse scales predominate; moderate red coloration/moderate PT. 4=severe; thick tenacious scale predominates; deep red coloration/severe PT. Treatment success=ISGA score 0 or 1, and a minimum improvement in the ISGA score of 2 grades from BL to week 8.|8 weeks|ITT||participants|||Number
766705|NCT00688519|Secondary|Number of Subjects Who Have an ISGA Score of 0 or 1 at Week 8|Assessment (on a scale of 0 to 4) was made as a visual average of all lesions, except those on the face/scalp. 0=clear; minor residual discoloration; no erythema/scaling/plaque thickness (PT). 1=almost clear; occasional fine scale/faint erythema/barely perceptible PT. 2=mild; fine scales predominate; light red coloration/mild PT. 3=moderate; coarse scales predominate; moderate red coloration/moderate PT. 4=severe; thick tenacious scale predominates; deep red coloration/severe PT.|8 weeks|ITT||participants|||Number
766706|NCT00688519|Secondary|Number of Subjects With a Target Lesion Score of 0 for Plaque Thickness at Week 8|Plaque thickness was assessed on a 6-point scale. 0=no evidence of plaque thickness. 1=barely perceptible plaque thickness, approximately 0.5 millimeters (mm). 2=mild plaque thickness, approximately 1 mm. 3=moderate plaque thickness, approximately 1.5 mm. 4=marked plaque thickness, approximately 2 mm. 5=severe plaque thickness, approximately 2.5 mm or more.|8 weeks|ITT||participants|||Number
766707|NCT00688519|Secondary|Number of Subjects With a Target Lesion Score of 0 or 1 for Scaling and at Least a 2 Grade Improvement From Baseline at Week 8|Scaling was assessed on a 6-point scale. 0=no evidence of scaling. 1=minimal; occasional fine scale over less than 5% of the lesion. 2=mild, fine scales predominate. 3=moderate; course scales predominate. 4=marked; thick non-tenacious scale predominates. 5=severe; very thick tenacious scale predominates.|8 weeks|ITT||participants|||Number
766708|NCT00688519|Secondary|Number of Subjects With a Target Lesion Score of 0 or 1 for Erythema and at Least a 2-grade Improvement From Baseline at Week 8|Erythema was assessed on a 6-point scale. 0=no evidence of erythema; hyperpigmentation may be present. 1=faint erythema. 2=light red coloration. 3=moderate red coloration. 4=bright red coloration. 5=dusky to deep red coloration.|8 weeks|ITT||participants|||Number
766709|NCT00688519|Primary|Number of Subjects With Treatment Success, Assessed Per the Investigator's Static Global Assessment (ISGA)|Assessment (on a scale of 0 to 4) was made as a visual average of all lesions, except those on the face/scalp. 0=clear; minor residual discoloration; no erythema/scaling/plaque thickness (PT). 1=almost clear; occasional fine scale/faint erythema/barely perceptible PT. 2=mild; fine scales predominate; light red coloration/mild PT. 3=moderate; coarse scales predominate; moderate red coloration/moderate PT. 4=severe; thick tenacious scale predominates; deep red coloration/severe PT. Treatment success=ISGA score 0 or 1, and a minimum improvement in the ISGA score of 2 grades from BL to week 8.|8 weeks|Intent-to-Treat (ITT) Population||particpants|||Number
766710|NCT00688545|Primary|JIA Concomitant Medications|JIA medications by class: GI protective agents (eg, proton-pump inhibitors, antacids, surcalfate), other GI, DMARDs, biologics, antihypertensives, NSAIDs (Celecoxib, Diclofenac, Ibuprofen, Meloxicam, Naproxen, other NSAIDs), corticosteroids (oral, IV, intra-articular, other forms), analgesics Acetaminophen, Opioids, other). Participants could receive more than 1 medication.|Year 2 or early termination|Safety Analysis Set subset of participants who received JIA concomitant medications||Participants|||Number
766711|NCT00688545|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Participants with multiple occurrences of an AE within a category were counted once within the category. AEs attributed to the NSAID (celecoxib or nsNSAID) utilized at time of event, regardless of the initial NSAID treatment at Registry entry.|Baseline up to 2 years|Safety Analysis Set: participants who were prescribed at least one dose of any NSAID. Participants who switched treatment were counted for the NSAID utilized at the time of the event, regardless of the initial NSAID treatment at enrollment.||Participants|||Number
766712|NCT00688636|Secondary|Mean Erythrocyte Sedimentation Rate|erythrocyte sedimentation rate value - blood test|one year|||mm/h||Full Range|Median
766713|NCT00688636|Secondary|C-reactive Protein Concentration as a Surrogate Marker of Inflammation|The CRP was obtained at each study visit as a surrogate marker of inflammation. The CRP was recorded as milligram per deciliter (mg/dl). A normal CRP was 0-0.8 mg/dl; levels exceeding 0.8 mg/dl indicated inflammation.|one year|||mg/dL||Full Range|Median
766714|NCT00688636|Secondary|Histological Recurrence of Crohn's Disease as Determined From Biopsies of Neo-terminal Ileum Above the Ileocolonic Anastomosis|Histologic recurrence based on a histologic activity score and the presence of polymononuclear cells. The maximum score is 14 per biopsy site.|One year|Histologic activity score||participants|||Number
766737|NCT00688688|Secondary|Percentage of Participants With Zero Incontinence Episodes at Months 1, 3, 6, 9 and 12 and the Final Visit|The percentage of participants with no incontinence episodes for the 3 days prior to each clinic visit derived from the micturition diary recorded by the patient.|Months 1, 3, 6, 9 and 12|The full analysis set-Incontinence included all patients who took at least 1 dose of double-blind study drug with a baseline & at least 1 postbaseline micturition measurement in the visit diary & who had at least 1 incontinence episode at baseline. N is the number of patients included at each time point. LOCF was used for the Final Visit analysis.||percentage of participants|||Number
766715|NCT00688636|Secondary|Clinical Recurrence at One Year: Defined by Crohn's Disease Activity Index (CDAI) > 200|The Crohn's Disease Activity Index (CDAI) is calculated by a measurement of symptoms, signs, and lab tests over a time period of the previous 7 days. The CDAI includes: Number of very soft stools; sum of abdominal pain ratings: (0=none, 1= mild, 2=moderate, 3=severe); general well being (0=well, 1=slightly below par, 2=poor, 3=very poor, 4=terrible); Symptoms or findings presumed related to Crohn's disease (present): arthritis or arthralgia, iritis or uveitis, erythema nodosum, pyoderma gangrenosum, aphthous stomatitis, anal fissure, fistula or perirectal abscess, other bowel related fistula, febrile episode over 100 degrees during past week, taking lomotil or opiates for diarrhea, abnormal mass (0=none; 0.4=questionable; 1=present) hematocrit [(typical-current) X 6] Normal average male = 47, female =42, body weight|One year|CDAI score > 200||participants|||Number
766716|NCT00688636|Primary|Endoscopic Recurrence: the Proportion of Patients in Endoscopic Recurrence at One Year|Endoscopic recurrence was defined as i2,i3,i4. We used the Rutgeerts’ Endoscopic Scoring System. Scores as follows i0, no lesions; i1, 5 or fewer aphthous lesions; i2, more than 5 aphthous lesions with normal mucosa between the lesions or skip areas of larger lesions or lesions confined to the ileocolonic anastomosis; i3, diffuse, aphthous ileitis with diffusely inflamed mucosa; and i4, diffuse inflammation with large ulcers, nodules, and/or narrowing. Endoscopic recurrence was defined as i2,i3,i4 and endoscopic remission was defined as i0 or i1.|one year|The proportion of patients with endoscopic recurrence (> or = i2) at 1 year after surgery||participants|||Number
766717|NCT00688662|Secondary|Percentage of Patients With a Successful Primary Outcome, Out of Those With Abnormal Sphincter Manometry.|Successful outcome was defined using the primary outcome definition of success at 12 months post randomization. Abnormal sphincter manometry was determined as a basal pressure of more than 40mm Hg in both leads.|1 year|Participants with abnormal sphincter manometry||percentage of participants with success|||Number
766718|NCT00688662|Primary|Percentage of Participants With Success|The primary outcome was a dichotomous (success/failure) variable. Success was defined as patients having a RAPID score of <6 days at months 9 and 12 post-procedure, without re-intervention and without use of prescription analgesics during months 10, 11 and 12 unless used for non-abdominal pain for no more than 14 days. The subject was considered a failure if the 12-month RAPID score was missing or collected outside the acceptable window. If the 9-month RAPID was missing, or outside of the window, then the 6-month value was used when available.|1 year|The primary analysis was conducted with the intention-to-treat population defined as all randomized patients.||percentage of paricipants with success||95% Confidence Interval|Number
766719|NCT00688688|Secondary|Safety as Assessed by Adverse Events (AEs), Vital Signs, Laboratory Tests, Physical Examination and Electrocardiogram|"An abnormality identified during a medical test was defined as an AE if the abnormality induced clinical signs or symptoms, required active intervention, interruption or discontinuation of study drug or was clinically significant. The Investigator assessed each AE for causal relationship (not related, possible or probable) to study drug. A serious AE (SAE) was any untoward medical occurrence that: resulted in death, was life-threatening, resulted in significant disability/incapacity or congenital anomaly/birth defect, required or prolonged hospitalization or was a medically important event.
The data reported represent the number of participants with adverse events in each category."|From the first dose of double-blind study drug up until 30 days after the last dose of study drug, up to 13 months.|The number of participants analyzed represents the Safety Analysis Set (SAF), including all randomized patients who took at least one dose of double-blind study drug.||participants|||Number
766720|NCT00688688|Secondary|Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC)|The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Improvement was defined as at least a one point improvement from Baseline to post-baseline and a major improvement was defined as at least a two point improvement from Baseline to post-baseline in PPBC score.|Baseline and Month 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values. LOCF was used for the Final Visit analysis.||percentage of participants|||Number
766721|NCT00688688|Secondary|Change From Baseline to Months 3, 6, 12 and Final Visit in Number of Non-study Related Visits to Physician|The number of times the patient visited a physician’s office during the 4 weeks prior to each study visit (excluding study visits) because of the patient’s bladder condition.|Baseline and Months 3, 6 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values. LOCF was used for the Final Visit analysis.||Physician visits||Standard Deviation|Mean
766722|NCT00688688|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)|The EQ-5D is an international, standardized, generic instrument for describing and evaluating health status. Health status is assessed by patients evaluating their health on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (=0) and 'Best imaginable health state' (=100). On the EQ-5D VAS, a positive change from Baseline indicates improvement.|Baseline and Months 1, 3, 6, 9 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values. LOCF was used for the Final Visit analysis.||scores on a scale||Standard Deviation|Mean
766754|NCT00688701|Secondary|Change From Baseline in Body Weight at Week 12|Change was calculated by subtracting baseline value from Week 12 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 12|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.||kilogram||Standard Error|Least Squares Mean
766723|NCT00688688|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:
I am not anxious or depressed; I am moderately anxious or depressed; I am extremely anxious or depressed. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit."|Baseline and Month 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.||participants|||Number
766724|NCT00688688|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and evaluating health status. Participants were asked to indicate which of the following statements best describes their health state:
I have no pain or discomfort; I have moderate pain or discomfort; I have extreme pain or discomfort. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit."|Baseline and Month 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.||participants|||Number
766725|NCT00688688|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score|The EQ-5D is a standardized, nondisease-specific instrument for describing health status. Participants were asked which statement best describes their health state with regard to usual activities (work, study or leisure): I have no problems performing my usual activities; I have some problems performing my usual activities; I am unable to perform my usual activities. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available at that Visit.|Baseline and Month 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.||participants|||Number
766726|NCT00688688|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-Care Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and evaluating health status. Participants were asked to indicate which of the following statements best describes their health state:
I have no problems with self-care; I have some problems washing or dressing myself; I am unable to wash or dress myself. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit."|Baseline and Month 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.||participants|||Number
766727|NCT00688688|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and evaluating health status. Participants were asked to indicate which of the following statements best describes their health state:
I have no problems in walking about; I have some problems in walking about; I am confined to bed.
In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit."|Baseline and Month 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.||participants|||Number
766728|NCT00688688|Secondary|Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with daily activities over the last 7 days. Percent activity impairment is derived from the patient’s assessment of the degree to which OAB affected their regular daily activities. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement.|Baseline and Months 3, 6 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline value. LOCF was used for the Final Visit analysis.||Percent activity impairment||Standard Deviation|Mean
766729|NCT00688688|Secondary|Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent overall work impairment takes into account both hours missed due to OAB symptoms and the patient’s assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement.|Baseline and Months 3, 6 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values who were employed. LOCF was used for the Final Visit analysis.||Percent overall work impairment||Standard Deviation|Mean
766774|NCT00688870|Other Pre-specified|Percentage of Participants With Pre-specified Systemic Events: Toddler Dose (15 Months of Age).|Systemic events (any fever >=38 degrees C, decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after the toddler dose (15 months of age)|Safety population: all participants who received the toddler dose (15 months of age). n= number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.||percentage of participants|||Number
766730|NCT00688688|Secondary|Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent impairment while working was derived from the patient’s assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement.|Baseline and Months 3, 6 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values who were employed. LOCF was used for the Final Visit analysis.||Percent impairment while working||Standard Deviation|Mean
766731|NCT00688688|Secondary|Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent of work time missed is derived from the number of hours of work missed due to OAB symptoms as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed. A negative change from baseline indicates improvement.|Baseline and Months 3, 6 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values who were employed. LOCF was used for the Final Visit analysis.||Percent work time missed||Standard Deviation|Mean
766732|NCT00688688|Secondary|Change From Baseline to Month 12 and Final Visit in Treatment Satisfaction-visual Analog Scale (TS-VAS)|The TS-VAS is a visual analog scale (VAS) that asks patients to rate their satisfaction with treatment by placing a vertical mark on a 10 cm line where the endpoints are labeled ‘No, not at all’ on the left (=0) to ‘Yes, completely satisfied’ on the right (=10). A positive change from baseline indicates improvement. LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate.|Baseline and Month 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug with a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of participants included at each time point (N) only includes those with baseline and post-baseline values. LOCF is used for the Final Visit.||scores on a scale||Standard Error|Least Squares Mean
766733|NCT00688688|Secondary|Change From Baseline to Month 12 and Final Visit in Patient Perception of Bladder Condition (PPBC)|"The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. A negative change from Baseline score indicates improvement.
LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate."|Baseline and Month 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug with a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of participants included at each time point (N) only includes those with baseline and post-baseline values. LOCF is used for the Final Visit.||scores on a scale||Standard Error|Least Squares Mean
766734|NCT00688688|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score|"Health-related quality of life was assessed by the HRQL subscales (coping, concern, sleep and social interaction) of the overactive bladder questionnaire (OABq). The HRQL total score was calculated by adding the 4 HRQL subscale scores, and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from Baseline in HRQL score indicates improvements.
LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate."|Baseline and Months 1, 3, 6, 9 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug with a baseline & at least 1 postbaseline micturition measurement in the visit diary. N is the number of patients included at each time point. LOCF is used for the Final Visit.||scores on a scale||Standard Error|Least Squares Mean
766735|NCT00688688|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Symptom Bother Score|"Overactive bladder symptoms were assessed using the symptom bother scale of the overactive bladder questionnaire. The symptom bother scale consists of 8 questions answered by the patient on a scale from 1-6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from Baseline in symptom bother score indicates improvements.
LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate."|Baseline and Months 1, 3, 6, 9 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug with a baseline & at least 1 postbaseline micturition measurement in the visit diary. N is the number of patients included at each time point. LOCF is used for the Final Visit.||scores on a scale||Standard Error|Least Squares Mean
766736|NCT00688688|Secondary|Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Months 1, 3, 6, 9 and 12 and the Final Visit|The percentage of participants with at least a 50% decrease from baseline in mean number of incontinence episodes per 24 hours during the 3 days prior to each clinic visit derived from the patient micturition diary.|Baseline and Months 1, 3, 6, 9 and 12|The full analysis set-Incontinence included all patients who took at least 1 dose of double-blind study drug with a baseline & at least 1 postbaseline micturition measurement in the visit diary & who had at least 1 incontinence episode at baseline. N is the number of patients included at each time point. LOCF was used for the Final Visit analysis.||percentage of participants|||Number
766985|NCT00690482|Secondary|Forced Vital Capacity|Mean change in FVC from baseline to Week 4 (last measurement post dose used, if data missing)|Baseline and Week 4|The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.||L||Full Range|Mean
766738|NCT00688688|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours|"Nocturia is defined as waking at night one or more times to void. The average number of times a patient urinated (excluding incontinence only episodes) during sleeping time per day was derived from the 3-day patient micturition diary.
LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate."|Baseline and Months 1, 3, 6, 9 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug with a baseline & at least 1 postbaseline micturition measurement in the visit diary. This analysis includes patients with at least 1 nocturia episode at Baseline. N is the number of patients included at each time point. LOCF is used for the Final Visit.||nocturia episodes||Standard Error|Least Squares Mean
766739|NCT00688688|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in the Mean Number of Pads Used Per 24 Hours|"The average number of times a patient records a new pad used per day during the 3-day micturition diary period.
LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate."|Baseline and Months 1, 3, 6, 9 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug with a baseline & at least 1 postbaseline micturition measurement in the visit diary. This analysis includes patients who had at least 1 use of a pad at Baseline. N is the number of patients included at each time point. LOCF is used for the Final Visit||pads||Standard Error|Least Squares Mean
766740|NCT00688688|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Level of Urgency|Average of patients’ ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in a 3-day micturition diary according to the Patient Perception of Intensity of Urgency Scale: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could delay voiding a short while; 3 = Severe urgency, could not delay voiding; 4 = Urge incontinence, leaked before arriving to the toilet. LS means are generated from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate.|Baseline and Months 1, 3, 6, 9 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug with a baseline and at least 1 postbaseline micturition measurement in the visit diary. N is the number of patients included at each time point. LOCF is used for the Final Visit analysis.||scores on a scale||Standard Error|Least Squares Mean
766741|NCT00688688|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours|The average number of urgency episodes (the sudden, compelling desire to pass urine that is difficult to defer) derived from episodes classified by the patient in a 3-day micturition diary as 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0=No urgency; 1=Mild urgency; 2=Moderate urgency, could delay voiding a short time; 3=Severe urgency, could not delay voiding; 4=Urge incontinence, leaked before arriving to the toilet. LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate.|Baseline and Months 1, 3, 6, 9 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug with a baseline & at least 1 postbaseline micturition measurement in the visit diary. This analysis includes patients with at least 1 urgency episode at Baseline. N is the number of patients included at each time point. LOCF is used for the Final Visit.||urgency episodes||Standard Error|Least Squares Mean
766742|NCT00688688|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours|The involuntary leakage of urine accompanied or immediately proceeded by urgency, derived from the number of incontinence episodes classified by the patient in a 3-day micturition diary as 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0=No urgency; 1=Mild urgency; 2=Moderate urgency, could postpone voiding a short time; 3=Severe urgency, could not postpone voiding; 4=Urge incontinence, leaked before arriving to toilet. LS means are from the ANCOVA model with treatment group, previous study history, gender and geographical regions as fixed factors and baseline as a covariate.|Baseline and Months 1, 3, 6, 9 and 12|The full analysis set-Incontinence included all patients who took at least 1 dose of double-blind study drug with a baseline & at least 1 postbaseline micturition measurement in the visit diary & who had at least 1 urgency incontinence episode at baseline. N is the number of patients included at each time point. LOCF is used for the Final Visit.||urgency incontinence episodes||Standard Error|Least Squares Mean
766743|NCT00688688|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Volume Voided Per Micturition|The average volume voided per micturition was calculated from the volume of each micturition measured by the patient and recorded in a micturition diary for 3 days prior to clinic visits at Baseline and months 1, 3, 6, 9 and 12/end of treatment. LS means were generated from the ANCOVA model with treatment group, previous study history, gender and geographical regions as fixed factors and baseline as a covariate.|Baseline and Months 1, 3, 6, 9 and 12|The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug with a baseline and at least 1 post baseline micturition measurement in the visit diary. N is the number of patients included in the analysis at each time point. Last observation carried forward (LOCF) was used for the Final Visit analysis.||mL||Standard Error|Least Squares Mean
766744|NCT00688688|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Incontinence Episodes Per 24 Hours|The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days prior to clinic visits at Baseline and months 1, 3, 6, 9 and 12/end of treatment. Least squares (LS) means were generated from the analysis of covariance (ANCOVA) model with treatment group, previous study history, gender and geographical regions as fixed factors and baseline as a covariate.|Baseline and Months 1, 3, 6, 9 and 12|The full analysis set-Incontinence included all patients who took at least 1 dose of double-blind study drug with a baseline & at least 1 postbaseline micturition measurement in the visit diary & who had at least 1 incontinence episode at baseline. N is the number of patients included at each time point. LOCF was used for the Final Visit analysis.||incontinence episodes||Standard Error|Least Squares Mean
766986|NCT00690482|Primary|Clinical COPD Questionnaire|Mean change in Total CCQ from baseline to Week 4 (last measurement post dose used, if data missing). Scores for total CCQ range from 0 (low symptoms) to 6 (high symptoms).|Baseline and Week 4|The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.||Scores on a scale||Full Range|Mean
766745|NCT00688688|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Micturitions Per 24 Hours|The average number of micturitions (urinations) per 24 hours was derived from the number of times a patient urinates (excluding incontinence only episodes) per day recorded by the patient in a micturition diary for 3-days prior to clinic visits at Baseline and months 1, 3, 6, 9 and 12/end of treatment. Least squares (LS) means were generated from the analysis of covariance (ANCOVA) model with treatment group, previous study history, gender and geographical regions as fixed factors and baseline as a covariate.|Baseline and Months 1, 3, 6, 9 and 12|The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug with a baseline and at least 1 post baseline micturition measurement in the visit diary. N is the number of patients included in the analysis at each time point. Last observation carried forward (LOCF) was used for the Final Visit analysis.||micturitions||Standard Error|Least Squares Mean
766746|NCT00688688|Primary|Number of Participants With and Severity of Treatment-emergent Adverse Events (TEAEs)|"An adverse event (AE) was defined as any untoward medical occurrence in a patient administered a study drug and which did not necessarily have a causal relationship with the treatment. The investigator assessed the severity of each AE, including abnormal laboratory values, as follows:
Mild: No disruption of normal daily activities; Moderate: Affected normal daily activities; Severe: Inability to perform daily activities."|From the first dose of double-blind study drug up until 30 days after the last dose of study drug, up to 13 months.|The number of participants analyzed represents the Safety Analysis Set (SAF), including all randomized patients who took at least one dose of double-blind study drug.||participants|||Number
766747|NCT00688701|Other Pre-specified|Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia|Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the patient required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.|First dose of study drug up to 3 days after the last dose administration|Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.||participants|||Number
766748|NCT00688701|Other Pre-specified|Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 12|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 12|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.||percentage of participants|||Number
766749|NCT00688701|Other Pre-specified|Change From Baseline in Glucose Excursion at Week 12|Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the standardized meal test (performed in selected sites), before study drug administration. Change was calculated by subtracting baseline value from Week 12 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 12|Subgroup for standardized meal test. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline glucose excursion assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
766750|NCT00688701|Secondary|Percentage of Patients Requiring Rescue Therapy During the Double-Blind Treatment Period|Routine fasting self monitored plasma glucose (SMPG) and central laboratory FPG values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG was performed. Threshold values for fasting SMPG/FPG: from baseline to Week 8: >270 milligram/deciliter (mg/dL) (15 mmol/L) and from Week 8 to Week 12: >240 mg/dL (13.3 mmol/L). For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline up to Week 12|mITT population.||percentage of participants|||Number
766751|NCT00688701|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 12|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 12|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.||percentage of participants|||Number
766752|NCT00688701|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 12|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 12|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.||percentage of participants|||Number
766753|NCT00688701|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12|Change was calculated by subtracting baseline value from Week 12 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 1 day after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 12|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline FPG assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
766755|NCT00688701|Secondary|Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Week 12|The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal (performed in selected sites). Change was calculated by subtracting baseline value from Week 12 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 12|Subgroup for standardized meal test. Missing data was imputed using last observation carried forward (LOCF). Here, number of patients analyzed = patients with baseline and at least 1 post-baseline 2-hour PPG assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
766756|NCT00688701|Primary|Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12|Absolute change = HbA1c value at Week 12 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 12|mITT population:all randomized patients who received at least 1 dose;had baseline,at least 1 post-baseline efficacy assessment, irrespective of compliance with study protocol/procedures. Last observation carried forward used. Number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.||percentage of hemoglobin||Standard Error|Least Squares Mean
766757|NCT00688740|Secondary|Number of Participants With Second Primary Malignancies (Toxicity)|Toxicity (second primary malignancies)- defined as histopathologically proven cancer, excluding nonmelanomatous skin cancer, in situ carcinoma of the cervix, and in situ carcinoma of the breast.|up to 10 year follow-up|||Participants|||Number
766758|NCT00688740|Secondary|Number of Participants With Overall Survival Events|Overall Survival - time from the date of randomization up to the date of death of any cause.|up to 10 year follow-up|||Participants|||Number
766759|NCT00688740|Primary|Number of Participants With Disease-Free Survival Events|Disease-Free Survival (DFS)- are defined as local, regional or metastatic relapse or the date of second primary cancer or death from any cause whichever occurs first.|up to 10 year follow-up|The study was originally designed to have 90% power to detect a 26% risk reduction of relapsing for TAC compared to FAC (hazard ratio=0.74)||Participants|||Number
766760|NCT00688753|Secondary|Incidence of Adverse Events, Serious Adverse Events, and Death.||End of trial|Safety Set||% participants|||Number
766761|NCT00688753|Secondary|Median Progression Free Survival|PFS was defined as the time from first study drug administration to objective tumor progression or death from any cause.|End of trial|||days||95% Confidence Interval|Median
766762|NCT00688753|Secondary|Duration of Response|The DOR analysis applied only to patients whose overall response was CR or PR and was defined as the time from onset of response (CR/PR) to progression or death from any cause.|End of trial|In the final analysis, for central review, the DOR could not be calculated as only 1 patient in the PP and ITT sets met the criteria||days||95% Confidence Interval|Median
766763|NCT00688753|Secondary|Objective Response Rate|ORR is defined as the proportion of patients with tumor size reduction of a predefined amount and for a minimum time period. Response duration usually is measured from the time of initial response until documented tumor progression|End of trial|||% participants||90% Confidence Interval|Number
766764|NCT00688753|Secondary|Disease Control Rate (SD + PR + CR)|DCR was defined as the proportion of patients with a best overall response of CR, PR or SD and ORR as the percentage of patients with CR or PR|6 mos|PP,ITT||% Participants||90% Confidence Interval|Number
766765|NCT00688753|Primary|To Evaluate Efficacy of RAD001 as Monotherapy for the Treatment of Papillary Renal Cancer. Efficacy is Defined as the Percentage of Patients Progression-free at 6 Months.|PFSR at 6 months based on central review|6 mos|PP, PPFF, ITT||% participants||80% Confidence Interval|Number
766766|NCT00688844|Other Pre-specified|Change From Baseline in Serotonin at 12 Months|Objective: 1 year prospective cohort of PKU patients introduced to sapropterin (Kuvan)to evaluate peripheral neurotransmitter changes across time.|Baseline and 12 months||||||
766767|NCT00688844|Primary|Change From Baseline in Phenylalanine Intake at 12 Months|Total dietary phenylalanine assessed through 3-day food records - calculated as average phenylalanine intake (grams/day) in the 3 days recorded|Baseline and 12 months|Dietary intake not submitted by 11 participants at 12 months.||grams per day||Standard Deviation|Mean
766768|NCT00688844|Primary|Change From Baseline in Total Dietary Protein Intake at 12 Months|Total dietary protein intake assessed through 3-day food records - calculated as average protein intake (grams/day) in the 3 days recorded|Baseline and 12 months|Dietary intake not submitted by 11 participants at 12 months.||grams per day||Standard Deviation|Mean
766769|NCT00688844|Primary|Change From Baseline in Plasma Phenylalanine at 12 Months|Full amino acid panel, including phenylalanine, analyzed in fasting plasma samples.|Baseline and 12 months|||Micromoles per liter||Standard Deviation|Mean
766770|NCT00688844|Primary|Change From Baseline in Percent (%) Fat Mass at 12 Months|Percent fat mass measured via dual energy x-ray absorptiometry (DXA)|Baseline and 12 months|Data missing for 3 participants||Percent Fat Mass||Standard Deviation|Mean
766771|NCT00688844|Primary|Change From Baseline in Percent (%) Lean Mass at 12 Months|% lean mass was measured via dual energy x-ray absorptiometry (DXA)|Baseline and 12 months|Data missing for 3 participants||Percent Lean Mass||Standard Deviation|Mean
766772|NCT00688844|Primary|Change From Baseline in Bone Mineral Density (BMD) at 12 Months|Change in bone mineral density (BMD) from baseline of Kuvan study to 12 months post-baseline|Baseline and 12 months|Data missing for 3 participants||grams/centimeter^2||Standard Deviation|Mean
766773|NCT00688844|Primary|Change From Baseline in BMI at 12 Months|Change in Body mass index (BMI) from baseline of Kuvan study to 12 months post-baseline|Baseline and 12 months|Data missing for 2 participants||kg/m^2||Standard Deviation|Mean
766987|NCT00690482|Primary|FEV1|Mean change in FEV1 from baseline to Week 4 (last measurement post dose used, if data missing)|Baseline and Week 4|The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.||L||Full Range|Mean
766988|NCT00690495|Secondary|Further Assessment of Injection Pain||during induction of anaesthesia and about 3 to 6 hours after end of anaesthesia||||||
766775|NCT00688870|Other Pre-specified|Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age)|Systemic events (any fever >=38 degrees C, decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after dose 3 of the infant series (6 months of age)|Safety population: all participants who received all 3 doses of the infant series vaccination (6 months of age). n=number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.||percentage of participants|||Number
766776|NCT00688870|Other Pre-specified|Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age)|Systemic events (any fever >=38 degrees C, decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after Dose 2 of the infant series (4 months of age)|Safety population: all participants who received the first 2 doses of the infant series vaccination (4 months of age). n= number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.||percentage of participants|||Number
766777|NCT00688870|Other Pre-specified|Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age)|Systemic events (any fever >=38 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after Dose 1 of the infant series (2 months of age)|Safety population: all participants who received dose 1 of the infant series vaccination (2 months of age). (n)= number of participants reporting yes for at least 1 day or no for all days.||percentage of participants|||Number
766778|NCT00688870|Other Pre-specified|Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (15 Months of Age).|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling and redness present); Mild (0.5 to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 4 days after the toddler dose (15 months of age)|Safety population: all participants who received the toddler dose (15 months of age). n= number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.||percentage of participants|||Number
766779|NCT00688870|Other Pre-specified|Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling and redness present); Mild (0.5 to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 4 days after Dose 3 of the infant series (6 months of age)|Safety population: all participants who received all 3 doses of the infant series vaccination (6 months of age). n=number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.||percentage of participants|||Number
766780|NCT00688870|Other Pre-specified|Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling and redness present); Mild (0.5 to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 4 Days after Dose 2 of the infant series (4 months of age)|Safety population: all participants who received the first 2 doses of the infant series vaccination (4 months of age). n= number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.||percentage of participants|||Number
766781|NCT00688870|Other Pre-specified|Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age).|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling and redness present); Mild (0.5 to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 4 days after Dose 1 of the infant series (2 Months of Age)|Safety population: all participants who received dose 1 of the infant series vaccination (2 months of age). (n)= number of participants reporting yes for at least 1 day or no for all days.||percentage of participants|||Number
766782|NCT00688870|Other Pre-specified|GMC for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Toddler Dose|Antibody GMC as measured in mcg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|1 month after the toddler dose (16 months of age)|Evaluable immunogenicity population: had treatments as randomized at all 3 doses, blood drawn within specified timeframes, had at least 1 valid and determinate assay result for the proposed analysis, and no major protocol violations.||GMC mcg/mL||95% Confidence Interval|Geometric Mean
766783|NCT00688870|Other Pre-specified|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Infant Series|Antibody GMC as measured in mcg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|1 month after the 3-dose infant series (7 months of age)|Evaluable immunogenicity population: had treatments as randomized at all 3 doses, blood drawn within specified timeframes, had at least 1 valid and determinate assay result for the proposed analysis, and no major protocol violations.||GMC mcg/mL||95% Confidence Interval|Geometric Mean
766784|NCT00688870|Secondary|Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Mcg/mL, 1 Month After the Toddler Dose|Percentage of participants achieving a predefined antibody level of greater than or equal to 0.35 mcg/mL along with the corresponding exact 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|1 month after toddler dose (16 months of age)|Evaluable immunogenicity population: had treatments as randomized at all 4 doses, blood drawn within specified timeframes, had at least 1 valid and determinate assay result for the proposed analysis, and no major protocol violations.||percentage of participants||95% Confidence Interval|Number
766785|NCT00688870|Primary|Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (Mcg)/mL, 1 Month After the Infant Series.|Percentage of participants achieving a predefined antibody level of greater than or equal to 0.35 mcg/mL along with the corresponding exact 95% confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|1 month after the infant series (7 months of age)|Evaluable immunogenicity population: had treatments as randomized at all 3 doses, blood drawn within specified timeframes, had at least 1 valid and determinate assay result for the proposed analysis, and no major protocol violations.||percentage of participants||95% Confidence Interval|Number
766786|NCT00689026|Primary|The Percentage of Patients That Received a Quality of Colonoscopy Preparation Rating of <=2 on a 5 Point Likert Scale.|The quality of colonoscopy preparations as rated by blinded colonoscopists on a 5-point Likert Scale where 1=excellent, 2=good, 3=fair, 4=poor, 5=inadequate. It was expected that at least 100 patients would complete the trial.|The outcome was measured at the completion of the colonscopy procedure. Average time to completion two hours|13 patients were excluded from the Experimental Arm (12 cancelled their appointment and 1 did not complete the prep) and 6 were excluded from the Control Arm (5 cancelled their procedure and 1 withdrew from the trial) therefore results were analyzed and compared using the chi-square statistics-Validated Aronchik colonoscopy cleansing grading scale.||percentage of patients|||Number
766787|NCT00689052|Secondary|Change From Baseline in Mean Tender Point Threshold|The Tender Point Pain Threshold will be assessed for all 18 tender points by a study clinician. A dolorimeter will be used to exert the pressure at each point and to measure the threshold reading; when the patient first indicates pain, the threshold will be recorded in kg/sq.cm ;If the patient reports pain before 1.0 kg/sq.cm is reached (>0 kg/sq.cm), 1.0 kg/sq.cm will be entered. If the patient does not report pain when the maximum pressure is applied (10.0 kg/sq.cm),0 (no pain) will be entered.|Baseline and Week 29|FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))|||||
766788|NCT00689052|Secondary|Frequency of Rescue Medication for Pain|Acetaminophen/paracetamol (maximum of 4 g/day) to be allowed as rescue medication for pain.|Week 29|FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))|||||
766789|NCT00689052|Secondary|Clinical Global Impression of Severity (CGI-S Scores)|Clinical Global Impression of Severity (CGI-S) Scale is a clinician’s assessment of patient’s severity of illness. The score ranges from 1 = normal, not at all ill to 7 = among the most extremely ill patients|Baseline and Week 29|FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))|||||
766790|NCT00689052|Secondary|Medical Outcomes Study (MOS) Sleep Scale (Change From Baseline)|The Medical Outcomes Study (MOS) sleep scale is a 12-item (MOS1 to MOS12) self reporting sleep measure.|Baseline and Week 29|FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))|||||
766791|NCT00689052|Secondary|Multidimensional Assessment of Fatigue (MAF) Index (Change From Baseline)|The Multidimensional Assessment of Fatigue (MAF) Index is a 16-item, self-reporting instrument designed to collect data on four dimensions of fatigue- severity, distress, degree of interference in activities of daily living, and timing .|Baseline and Week 29|FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))|||||
766792|NCT00689052|Secondary|Euroqol- 5 Dimensions (EQ-5D) Survey (Change From Baseline)|The Euroqol- 5 Dimension (EQ-5D) Health Survey is a generic, multidimensional, health related, quality-of-life instrument that contains two parts-a health status profile and a visual analog scale (VAS) to rate global health-related quality of life. The profile contains five items corresponding to five health domains- mobility, self-care, usual activities, pain/discomfort, and mood. A single score is generated for each health state. Data from the EQ-5D can be converted into 243 unique health states. For each health state, there exists a corresponding valuation that allows the patient’s health to be represented as an index, which is a value between -0.594 and 1; the higher the score, the better the quality of life.|Baseline and Week 29|FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))|||||
766793|NCT00689052|Secondary|The Short Form 36 (SF-36) Health Survey (Change From Baseline) (Excluding the Physical Functioning Subscale(PF)).|"The SF-36 Health Survey is a self-administered 36-item instrument completed by the patient .
SF 36 has subscales as follows: i) physical functioning (PF), ii) role limitations due to physical problems (RP), iii) bodily pain (BP), iv) general health perceptions (GH), v) vitality (VT), vi) social function (SF), vii) role limitations due to emotional problems (RE), viii) mental health (MH),ix)physical component summary (PCS)and x)mental component summary(MCS).
Among the subscales, Physical functioning was key secondary endpoint while other were additional secondary endpoints.
Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. The number of items per domain varies from 2 to 1"|Baseline and Week 29|FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))|||||
766794|NCT00689052|Secondary|Hospital Anxiety and Depression Scale (HADS) (Change From Baseline).|The Hospital Anxiety and Depression Scale (HADS) measures the severity of anxiety and depression. The severity score ranges from: 0 = least severe to 3 = most severe. The total score ranges from 0 to 21; the higher the score, the more severe the anxious/depressive symptoms|Baseline and Week 29|FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))|||||
766840|NCT00689104|Secondary|Change From Baseline to Week 8 and Week 12 in Mean Number of Micturitions Per 24 Hours|The average number of micturitions (urinations) per 24 hours was calculated from the number of micturitions recorded by the patient in a micturition diary for 3-days before the Baseline, Week 8 and 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 8 and 12|The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. The number of patients included in the calculation for each time point is noted as “N”. LOCF was not used in this analysis.||micturitions||Standard Error|Least Squares Mean
766795|NCT00689052|Secondary|Fibromyalgia Impact Questionnaire (FIQ) Total Score (Change From Baseline)|"FIQ is a self-reported scale completed by the patient that measures patient status, progress, and outcomes over the past week.
The FIQ is composed of a total of 20 items; the first 11 items measure physical functioning, and each item is rated on a four-point Likert scale. Items 12 and 13 measure the number of days the patient felt well and the number of days the patient felt unable to work due to their fibromyalgia symptoms. Items 14 through 20 are numerical, 11-point Likert scales (marked in 10-point increments) on which the patient rates work difficulty, pain, fatigue, morning tiredness, stiffness, anxiety, and depression. The total score ranges from 0 to 80. A higher score indicates a more negative impact"|Baseline and Week 29|FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))|||||
766796|NCT00689052|Secondary|The Proportion of Patients With at Least a 30% or at Least a 50% Improvement Relative to Baseline in Pain (Assessed on the 11-point Likert Pain Scale|11-Point Likert Pain Scale is a numerical rating scale completed by the patient that measures the intensity of pain. The intensity scores range from: 0 = no pain to 10 = worst possible pain .|Baseline and Week 29|FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))|||||
766797|NCT00689052|Secondary|The Short Form 36 (SF-36) Health Survey, Physical Functioning Subscale (Change From Baseline).|"The SF-36 Health Survey is a self-administered 36-item instrument completed by the patient .
SF 36 has subscales as follows: i) physical functioning (PF), ii) role limitations due to physical problems (RP), iii) bodily pain (BP), iv) general health perceptions (GH), v) vitality (VT), vi) social function (SF), vii) role limitations due to emotional problems (RE), viii) mental health (MH),ix)physical component summary (PCS)and x)mental component summary(MCS).
Among the subscales, Physical functioning was key secondary endpoint while other were additional secondary endpoints.
Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. The number of items per domain varies from 2 to 1"|Baseline and Week 29|FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))|||||
766798|NCT00689052|Secondary|The Proportion of Patients “Very Much Improved” or “Much Improved” on the Patient’s Global Impression of Improvement (PGI-I) 7-point Scale|"PGI-I is a self-reported scale completed by the patient that measures the degree of improvement at the time of assessment.
The score ranges from 1 = very much improved to 7 = very much worse"|Week 29 (at the end of the maintenance phase)|FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))|||||
766799|NCT00689052|Primary|The Change in the Weekly Mean of the 24-hour Average Pain Score From a Daily Diary as Measured by the 11-point Likert Pain Scale|The 11-point Likert Pain Scale is a numerical rating scale completed by the patient that measures the intensity of pain. The intensity scores range from 0 (no pain) to 10 (worst possible pain)|Baseline and Week 29|FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))|||||
766800|NCT00689091|Secondary|Comparison of the Prospective and Retrospective Approaches to the Study Awareness Incidence.||Outcome of awareness will be assessed||||||
766801|NCT00689091|Secondary|Comparison of Retrospective vs. Prospective Approaches to Assessing the Incidence of Awareness||Outcome of awareness will be assessed||||||
766802|NCT00689091|Secondary|Anesthetic Induction Doses, Hypotension, and BIS Values.||Outcome of hypotension in relationship to induction doses and BIS values will be assessed||||||
766803|NCT00689091|Secondary|Incidence of Post-operative Nausea and Vomiting in Relationship to BIS Values.||outcome of post-operative nausea and vomiting will be assessed||||||
766804|NCT00689091|Secondary|PACU Pain Scores, Neurologic Exam, and Discharge Time in Relationship to BIS Values.||Outcome of pain scores, neurologic exam and discharge time will be assessed||||||
766805|NCT00689091|Secondary|Overall Use of Anesthetics Comparing the BIS to MAC Alerts.||Anesthetic dosing will be assessed||||||
766806|NCT00689091|Secondary|BIS Values and Anesthetic Dosing of Chronic Pain Patients.||Outcome of chronic pain patients will be assessed||||||
766807|NCT00689091|Secondary|Effect of Electronic Alerts on the Clinical Behavior of the Anesthesia Provider.||Outcome of the number of electronic alerts generated is assessed||||||
766808|NCT00689091|Secondary|Analysis of Interrupted Monitoring During the Use of the BIS.||Outcome of BIS monitoring is assessed||||||
766809|NCT00689091|Secondary|Relationship Between BIS Values and Hemodynamic Parameters.||Outcome of hemodynamic stability is assessed||||||
766810|NCT00689091|Secondary|The Relationship Between Cumulative Deep Hypnotic Time, Anesthetic Doses, and Mortality.||Outcome of mortality is assessed||||||
766811|NCT00689091|Secondary|Incidence and Type of Dreams During Anesthesia in Conjunction With MAC or BIS Values.||Outcomes of dreams is assessed||||||
766812|NCT00689091|Secondary|Predictors of Post-traumatic Stress Disorder Based on the Type of Awareness Event.||Outcome of post-traumatic stress disorder is assessed with the covariate of awareness||||||
766813|NCT00689091|Secondary|Incidence of Post-traumatic Stress Disorder.||Outcome of post-traumatic stress disorder as it relates to awareness is assessed||||||
766814|NCT00689091|Secondary|Meta-Analysis of Awareness Events in Conjunction With the BAG-RECALL Study Based at Washington University.||Outcome of awareness is assessed||||||
766815|NCT00689091|Primary|The Percentage of Incidences With Explicit Recall in the BIS Versus MAC Alert Groups.|By modified intention-to-treat analysis|Outcome of awareness is assessed 30-days after the operation|||Percentage of participants/30days||95% Confidence Interval|Number
766823|NCT00689104|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score|The EQ-5D is a standardized, nondisease-specific instrument for describing health status. Participants were asked which statement best describes their health state with regard to usual activities (work, study or leisure): I have no problems performing my usual activities; I have some problems performing my usual activities; I am unable to perform my usual activities. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available at that Visit.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.||participants|||Number
766816|NCT00689104|Secondary|Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) at Week 12 and Final Visit|The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Improvement was defined as at least a 1 point improvement from Baseline to post-baseline and a major improvement was defined as at least a 2 point improvement from Baseline to post-baseline in PPBC score.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants at each time point (N) only includes those with baseline and post-baseline values. LOCF was used for the Final Visit analysis.||percentage of participants|||Number
766817|NCT00689104|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Number of Non-study Related Visits to Physician|The number of times the patient visited a physician's office during the 4 weeks prior to each study visit (excluding study visits) because of the patient's bladder condition.|Baseline and Weeks 4, 8 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants at each time point (N) includes only patients with both baseline and post-baseline values. LOCF was used for the Final Visit analysis.||Physician visits||Standard Deviation|Mean
766818|NCT00689104|Secondary|Change From Baseline to Week 12 and Final Visit in Treatment Satisfaction on Visual Analog Scale (TS-VAS)|The TS-VAS is a visual analog scale (VAS) that asks patients to rate their satisfaction with treatment by placing a vertical mark on a 10 cm line where the endpoints are labeled 'No, not at all' on the left (=0) to 'Yes, completely satisfied' on the right (=10). LS means are from an ANCOVA model with treatment group, gender, and geographical regions as fixed factors and baseline as a covariate. A positive change from baseline indicates improvement.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants included at each time point (N) only includes those with baseline and post-baseline values. LOCF was used for the Final Visit analysis.||Scores on a scale||Standard Error|Least Squares Mean
766819|NCT00689104|Secondary|Change From Baseline to Week 12 and Final Visit in Patient Perception of Bladder Condition (PPBC)|The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems’; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. LS means are from an ANCOVA model with treatment group, gender, and geographical regions as fixed factors and baseline as a covariate. A negative change from Baseline score indicates improvement.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants included at each time point (N) only includes those with baseline and post-baseline values. LOCF was used for the Final Visit analysis.||Scores on a scale||Standard Error|Least Squares Mean
766820|NCT00689104|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)|The EQ-5D is an international, standardized, generic instrument for describing and evaluating health status. Health status is assessed by patients evaluating their health on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (=0) and 'Best imaginable health state' (=100). On the EQ-5D VAS, a positive change from baseline indicates improvement.|Baseline and Weeks 4, 8 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of participants at each time point (N) includes only patients with both baseline and post-baseline values. LOCF was used for the Final Visit analysis.||Scores on a scale||Standard Deviation|Mean
766821|NCT00689104|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:
I am not anxious or depressed; I am moderately anxious or depressed; I am extremely anxious or depressed. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit."|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.||participants|||Number
766822|NCT00689104|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:
I have no pain or discomfort; I have moderate pain or discomfort; I have extreme pain or discomfort. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit."|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.||participants|||Number
766839|NCT00689104|Secondary|Change From Baseline to Week 4, Week 8 and Week 12 in Mean Volume Voided Per Micturition|The average volume voided per micturition was calculated from the volume of each micturition measured by the patient and recorded in a micturition diary for 3 days before the Baseline and Week 4, 8 and 12 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 4, 8 and 12|The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. LOCF was not utilized in this analysis. The number of participants included in the calculation for each time point is noted as “N”.||mL||Standard Error|Least Squares Mean
766824|NCT00689104|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:
I have no problems with self-care; I have some problems washing or dressing myself; I am unable to wash or dress myself. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit."|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.||participants|||Number
766825|NCT00689104|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:
I have no problems in walking about; I have some problems in walking about; I am confined to bed.
In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit."|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.||participants|||Number
766826|NCT00689104|Secondary|Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with daily activities over the last 7 days. Percent activity impairment is derived from the patient’s assessment of the degree to which OAB affected their regular daily activities. A higher percentage indicates greater impairment. A negative change from baseline indicates improvement.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants at each time point (N) included patients with both baseline and post-baseline values. LOCF was used for the Final Visit analysis.||percent activity impairment||Standard Deviation|Mean
766827|NCT00689104|Secondary|Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent overall work impairment takes into account both hours missed due to OAB symptoms and the patient’s assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values who were employed. LOCF was used for the Final Visit analysis.||percent overall work impairment||Standard Deviation|Mean
766828|NCT00689104|Secondary|Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent impairment while working was derived from the patient’s assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values who were employed. LOCF was used for the Final Visit analysis.||percent impairment while working||Standard Deviation|Mean
766829|NCT00689104|Secondary|Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent of work time missed is derived from the number of hours of work missed due to OAB symptoms as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed. A negative change from baseline indicates improvement.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values who were employed. LOCF was used for the Final Visit analysis.||percent work time missed||Standard Deviation|Mean
766830|NCT00689104|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score|"Health-related quality of life was assessed by the HRQL subscales (coping, concern, sleep and social interaction) of the overactive bladder questionnaire (OABq). The HRQL total score was calculated by adding the 4 HRQL subscale scores, and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from Baseline in HRQL score indicates improvements.
LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate."|Baseline and Weeks 4, 8 and 12|"The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was utilized for the Final Visit analysis. The number of participants included in the calculation for each time point is noted as N."||Scores on a scale||Standard Error|Least Squares Mean
766870|NCT00689338|Secondary|Day 90 Survival|Percentage of participants known or assumed to be alive on Day 90.|Day 90|MITT||percentage of participants||95% Confidence Interval|Number
766989|NCT00690495|Primary|Incidence of Expression of Pain During Injection||during first propofol bolus|per protocol||participants|||Number
766831|NCT00689104|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Symptom Bother Score|"Overactive bladder symptoms were assessed using the symptom bother scale of the overactive bladder questionnaire. The symptom bother scale consists of 8 questions answered by the participant on a scale from 1-6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from Baseline in symptom bother score indicates improvements.
LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate."|Baseline and Weeks 4, 8 and 12|"The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for the Final Visit analysis. The number of participants included in the calculation for each time point is noted as N."||Scores on a scale||Standard Error|Least Squares Mean
766832|NCT00689104|Secondary|Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit|The percentage of participants with at least 50% decrease from baseline in mean number of incontinence episodes per 24 hours during the 3 days prior to each clinic visit derived from the patient micturition diary.|Baseline and Weeks 4, 8 and 12|The full analysis set-incontinence included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary & who had at least 1 incontinence episode at baseline. LOCF was used for the Final Visit analysis. N is the number of patients included at each time point.||percentage of participants|||Number
766833|NCT00689104|Secondary|Percentage of Participants With Zero Incontinence Episodes at Week 4, Week 8, Week 12 and the Final Visit|The percentage of participants with no incontinence episodes for the 3 days prior to each clinic visit derived from the micturition diary recorded by the patient.|Weeks 4, 8 and 12|The full analysis set-incontinence included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary & who had at least 1 incontinence episode at baseline. LOCF was used for the Final Visit analysis. N is the number of patients included at each time point.||percentage of participants|||Number
766834|NCT00689104|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Pads Used Per 24 Hours|"The average number of times a patient records a new pad used per day during the 3-day micturition diary period.
LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate."|Baseline and Weeks 4, 8 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary and who had at least one use of a pad at baseline. LOCF was used for the Final Visit analysis. N is the number of participants included at each time point.||pads||Standard Error|Least Squares Mean
766835|NCT00689104|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours|"Nocturia is defined as waking at night one or more times to void. The average number of times a patient urinated (excluding incontinence only episodes) during sleeping time per day was derived from the 3-day patient micturition diary.
LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate."|Baseline and Weeks 4, 8 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 post baseline micturition measurement in the visit diary and who had at least one nocturia episode at baseline. LOCF was used for the Final Visit analysis. N is the number of participants included at each time point.||nocturia episodes||Standard Error|Least Squares Mean
766836|NCT00689104|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Level of Urgency|Average of patients’ ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in a 3-day micturition diary according to the following 5-point categorical scale (Patient Perception of Intensity of Urgency Scale): 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 4, 8 and 12|"The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 post baseline micturition measurement in the visit diary. LOCF was used for the Final Visit analysis. The number of participants included in the calculation for each time point is noted as N."||Scores on a scale||Standard Error|Least Squares Mean
766837|NCT00689104|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Episodes (Grades 3 or 4) Per 24 Hours|The average number of urgency episodes (the sudden, compelling desire to pass urine, which is difficult to defer), derived from urgency episodes classified by the patient in a 3-day micturition diary as grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 4, 8 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 post baseline micturition measurement in the visit diary and at least 1 episode of urgency grade 3 or 4 at baseline. LOCF was used for the Final Visit analysis. N is the number of patients included at each time point.||Urgency episodes||Standard Error|Least Squares Mean
766838|NCT00689104|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours|The involuntary leakage of urine accompanied by or immediately proceeded by urgency, derived from the number of incontinence episodes classified by the patient in a 3-day micturition diary as 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 4, 8 and 12|The full analysis set-incontinence included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 post baseline micturition measurement in the visit diary & at least 1 urgency incontinence episode at baseline. LOCF was used for the Final Visit analysis. N = the number of patients included at each time point.||Urgency incontinence episodes||Standard Error|Least Squares Mean
766841|NCT00689104|Secondary|Change From Baseline to Week 8 and Week 12 in Mean Number of Incontinence Episodes Per 24 Hours|The average number of incontinence episodes (any involuntary leakage of urine) per 24 hours was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline, Week 8 and Week 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 8 and 12|The full analysis set-incontinence included all randomized patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 post baseline micturition measurement in the visit diary and at least 1 incontinence episode at baseline. The number of patients included at each time point is noted as “N”. LOCF was not utilized.||Incontinence episodes||Standard Error|Least Squares Mean
766842|NCT00689104|Secondary|Change From Baseline to Week 4 in Mean Number of Micturitions Per 24 Hours|The average number of micturitions (urinations) per 24 hours was calculated from the number of micturitions recorded by the patient in a micturition diary for 3-days before the Baseline and Week 4 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 4|The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. Last observation carried forward was not utilized in this analysis.||micturitions||Standard Error|Least Squares Mean
766843|NCT00689104|Secondary|Change From Baseline to Week 4 in Mean Number of Incontinence Episodes Per 24 Hours|The average number of incontinence episodes (any involuntary leakage of urine) per 24 hours was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline and Week 4 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 4|The full analysis set-Incontinence included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary and who had at least 1 incontinence episode at baseline. Last observation carried forward was not utilized in this analysis.||Incontinence episodes||Standard Error|Least Squares Mean
766844|NCT00689104|Secondary|Change From Baseline to Final Visit in Mean Volume Voided Per Micturition|The average volume voided per micturition was calculated from the volume of each micturition measured by the patient and recorded in a micturition diary for 3 days before the Baseline and Week 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 12|The Full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. Last observation carried forward was utilized.||mL||Standard Error|Least Squares Mean
766845|NCT00689104|Primary|Change From Baseline to End of Treatment (Final Visit) in Mean Number of Micturitions Per 24 Hours|The average number of micturitions (urinations) per 24 hours was derived from the number of times a patient urinates (excluding incontinence only episodes) per day recorded by the patient in a micturition diary for 3-days before the Baseline and Week 12 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 12|The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. Last observation carried forward was utilized.||micturitions||Standard Error|Least Squares Mean
766846|NCT00689104|Primary|Change From Baseline to End of Treatment (Final Visit) in Mean Number of Incontinence Episodes Per 24 Hours|The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline and Week 12 clinic visits. Least Squares (LS) Means were generated from an analysis of covariance (ANCOVA) model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 12 (final visit)|The full analysis set-Incontinence included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary and who had at least 1 incontinence episode at baseline. Last observation carried forward (LOCF) was utilized.||Incontinence episodes||Standard Error|Least Squares Mean
766847|NCT00689117|Secondary|The Percentage of Participants Who Had ISGA Scores of 0 or 1 at Week 12|The ISGA is a static (“snap-shot”) evaluation of acne severity performed by an investigator/assessor at every visit. The ISGA score is measured on a 6-point ordinal scale, where 0=Clear and 5=Very Severe. A score of 1=Skin Almost Clear: rare non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving and may be hyper-pigmented, though not pink-red) requiring no futher treatment in the Investigator's opinion.|Week 12|ITT Population||percentage of participants|||Number
766848|NCT00689117|Secondary|The Percentage of Participants With a Subjects Global Assessment Score of 0 or 1 at Week 12|The SGA score is a global evaluation of acne severity performed by participants at all visits and measured on a 5-point ordinal scale, where 0=My face is basically free of acne and 5=My face has blackheads and/or whiteheads. A score of 1=My face has several blackheads and/or whiteheads and small pimples, but there are no tender deep-seated bumps or cysts.|Week 12|ITT Population||participants|||Number
766849|NCT00689117|Secondary|Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12|Acne lesion counts (inflammatory [papules, pustules, nodules], non-inflammatory [open and closed comedones], and total) were performed on the face of participants. Change from baseline is defined as Week 12 values minus Baseline values. The total lesion count is the sum of the inflammatory and non-inflammatory lesion counts.|Baseline, Week 12|ITT Population||percent change||Standard Deviation|Mean
766850|NCT00689117|Primary|The Percentage of Participants Who Had a Minimum 2-grade Improvement in the Investigator’s Static Global Assessment (ISGA) Score From Baseline to Week 12|The ISGA is a static (“snap-shot”) evaluation of acne severity performed by an investigator/assessor at every visit. The ISGA score is measured on a 6-point ordinal scale, where 0=Clear and 5=Very Severe. Change is calculated as the Week 12 value minus the Baseline value.|Baseline, Week 12|ITT Population||percentage of participants|||Number
772190|NCT00732940|Secondary|Median Percent Change From Baseline in IgG at Week 24||Baseline, 24 Weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.||Percentage||Full Range|Median
766851|NCT00689117|Primary|Absolute Change From Baseline in Lesion Counts (Total, Inflammatory, and Non-inflammatory) at Week 12 (End of Study)|Acne lesion counts (inflammatory [papules, pustules, nodules], non-inflammatory [open and closed comedones], and total) were performed on the face of participants. Change from baseline is defined as Week 12 values minus Baseline values. The total lesion count is the sum of the inflammatory and non-inflammatory lesion counts.|Baseline, Week 12|Intent-to-Treat (ITT) Population: all participants who were randomized to and received at least one application of study product.||lesions||Standard Deviation|Mean
766852|NCT00689221|Secondary|Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) and Lab Parameters||Up to 50 months|Any clinically significant abnormal ECG and lab finding was planned to be reported as AE only so they have been captured in the below mentioned adverse event section.|||||
766853|NCT00689221|Secondary|Number of Participants With AEs Belonging to Standardized Medical Dictionary for Regulatory Activities (MedDRA) Queries (SMQs) Thromboembolic Events and Hemorrhage With NCI−CTC Toxicity Grade 3 or 4|Thromboembolic events (standardized MedDRA query [SMQ]) Grade 3 or 4 AEs encompassed hemiparesis and cerebrovascular accident, pulmonary embolism, and deep vein thrombosis. Thromboembolic events (SMQ) of any grade and of Grade 3 or 4 were generally more frequent in the Cilengitide + Temozolomide/Radiotherapy group than in the Temozolomide/Radiotherapy group but were still in the expected range of this patient population The severity of AEs was assessed according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTCAE) (version 3.0): Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening or disabling. Note: Death (Grade 5) was regarded as an outcome.|Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Sep 2008 until cut-off date (19 Nov 2012)|Safety population included all the participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. According to trial design safety data in trial arms (Cilengitide vs Control) were collected based on different visit frequency and different safety surveillance period.||Participants|||Number
766854|NCT00689221|Secondary|Number of Participants With Adverse Events (AEs), Serious AEs, Treatment-Related AEs, Treatment-Related Serious AEs, AEs Leading to Death, Treatment Related AEs Leading to Death, AEs of Grade 3 or 4 and Treatment Related AEs of Grade 3 or 4|An AE is defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. Treatment-emergent AEs are the events between first dose of study drug and up to 28 days after last dose of study treatment. A Serious AE is an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. Treatment-related AEs are the AEs which are suspected to be reasonably related to the study treatment (cilengitide, or radiotherapy, or temozolomide) as per investigator assessment. The severity of AEs was assessed according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTCAE) (version 3.0): Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening or disabling. Note: Death (Grade 5) was regarded as an outcome.|Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Sep 2008 until cut-off date (19 Nov 2012)|Safety population included all the participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. According to trial design safety data in trial arms (Cilengitide vs Control) were collected based on different visit frequency and different safety surveillance period.||Participants|||Number
766855|NCT00689221|Secondary|Number of Participants With Change From Baseline in Work Status at End of Study|Number of participants with change from baseline in work status (working full time [FT], part-time [PT], unemployed/retired [U/R]) at end of study (EOS) (up to cut-off date, [19 Nov 2012]) was reported. For the category ‘part-time’, the following sub-categories were defined: part-time due to basic disease (PT1); part-time not due to basic disease (PT2); part-time reason not known (PT3).|Baseline, End of study (up to cut-off date, [19 Nov 2012])|Safety population included all the participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. According to trial design safety data in trial arms (Cilengitide vs Control) were collected based on different visit frequency and different safety surveillance period.||participants|||Number
766856|NCT00689221|Secondary|EuroQol 5-Dimensions (EQ-5D) Questionnaire Index|The EuroQuol-5D (EQ-5D) questionnaire is a measure of health status that provides a simple descriptive profile and a single index value. The optional part of the questionnaire was not applied. The EQ-5D defines health in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 5 items are combined to generate health profiles. These profiles were converted to a continuous single index score using a one to one matching. The lowest possible score is -0.594 (death) and the highest is 1.00 (full health).|Up to 50 months|ITT population included all the participants who were randomized to study treatment. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||units on a scale||Standard Deviation|Mean
766857|NCT00689221|Secondary|European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Brain Module (EORTC QLQ-BN20) Sub-scale Scores|The QLQ-BN20 is a questionnaire specifically designed as the QLQ-C30 supplement for the evaluation of quality of life in brain tumor participants. It includes 4 multi-item sub-scales: future uncertainty, visual disorder, motor dysfunction, communication deficits, and 7 single-item scales: headaches, seizures, drowsiness, itchy skin, hair loss, weakness of legs, and bladder control. All items are rated on a 4-point Likert-type scale (‘1=not at all’, ‘2=a little’, ‘3=quite a bit’ and ‘4=very much’), and are linearly transformed to a 0-100 scale, with higher scores indicating more severe symptoms.|Up to 50 months|ITT population included all the participants who were randomized to study treatment. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable for the specified category.||units on a scale||Standard Deviation|Mean
766871|NCT00689338|Secondary|Time to First Negative Blood Culture|Negative blood culture defined as first negative culture that was not followed by a positive culture within the next 3 days (or 4 days if negative culture was observed on or after Day 10) from start of study medication until end of intravenous treatment (EOIVT). Time to first negative culture includes the first day of study medication.|Day 1 up to Day 42|MITT. N = participants who received a minimum of 3 days of dosing with anidulafungin, excluding participants who experienced invasive candidiasis either at baseline or while on anidulafungin and participants who did not have a first negative blood culture by EOIVT.||days||95% Confidence Interval|Mean
766858|NCT00689221|Secondary|European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Sub-scale Scores|The EORTC QLQ-C30 is a questionnaire including following sub-scales: global health status, functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social activity), symptom scales (fatigue, nausea and vomiting, and pain) and single items (dyspnoea, insomnia, appetite loss, constipation, diarrhoea and financial difficulties). Scores are averaged for each scale and transformed to 0-100 scale; higher score indicates better quality of life on global health status and functional scales and worse quality of life on symptom scales and financial difficulty scale.|Up to 50 months|ITT population included all the participants who were randomized to study treatment. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable for the specified category.||units on a scale||Standard Deviation|Mean
766859|NCT00689221|Secondary|Area Under the Plasma Concentration Curve From Time 0 to 6 Hours (AUC [0-6]) After Dose|The AUC (0-6) for cilengitide was calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2.1.|Day 1 of Week -1|"Analysis population included all participants of Cilengitide + Temozolomide + Radiotherapy group who received at least 1 cilengitide dose with plasma concentration data available on Day 1 of Week -1. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure."||hour*ng/mL||Standard Deviation|Mean
766860|NCT00689221|Secondary|Time to Maximum Plasma Concentration (Tmax)|The Tmax for cilengitide was calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2.1.|Day 1 of Week -1|"Analysis population included all participants of Cilengitide + Temozolomide + Radiotherapy group who received at least 1 cilengitide dose with plasma concentration data available on Day 1 of Week -1."||hours||Standard Deviation|Mean
766861|NCT00689221|Secondary|Maximum Observed Plasma Concentration (Cmax)|The Cmax for cilengitide was calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2.1.|Day 1 of Week -1|"Analysis population included all participants of Cilengitide + Temozolomide + Radiotherapy group who received at least 1 cilengitide dose with plasma concentration data available on Day 1 of Week -1."||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
766862|NCT00689221|Secondary|Progression Free Survival (PFS) Time - Investigator and Independent Read|"The PFS time is defined as the duration from randomization to either first observation of progressive disease (PD) or occurrence of death due to any cause. Investigator read is the assessment of all imaging by the treating physician at the local trial site and Independent Read is the assessment of all imaging centrally by an Independent Review Committee (IRC). Investigator’s assessed progression according to MacDonald criteria and IRC by Response Assessment in Neuro-Oncology Working Group (RANO) criteria using Gadolinium-enhanced magnetic resonance imaging.
Investigator and IRC read: Progression is defined as greater than 25 percent increase in the sum of the product of the largest perpendicular diameters of enhancing tumor compared to the smallest prior sum, or Worsening of an evaluable lesion(s),or Marked increase in T2/FLAIR non-enhancing lesions (IRC only) or Any new lesion"|Time from randomization to disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, Sep 2008 until cut-off date, (19 Nov 2012)|ITT population included all the participants who were randomized to study treatment.||Months||95% Confidence Interval|Median
766863|NCT00689221|Primary|Overall Survival (OS) Time|The OS time is defined as the time (in months) from randomization to death or last day known to be alive. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.|Time from randomization to death or last day known to be alive, reported between day of first participant randomized, that is, Sep 2008 until cut-off date, (19 Nov 2012)|ITT population included all the participants who were randomized to study treatment.||Months||95% Confidence Interval|Median
766864|NCT00689260|Secondary|Subject Perceptions of Easypod: Preference to Use Easypod Over Two Other rhGH Pen Injection Devices.||90 Days|The modified full analysis set includes all randomized subjects who received at least one injection using the easypod device and had valid device data. In addition, this total of 35 subjects was divided into 2 groups, Humatrope and Genotropin, based on their previous rhGH use.||Participants|||Number
766865|NCT00689260|Secondary|Subject Perceptions of Easypod: Storage Convenience Compared to Two Other rhGH Pen Injection Devices.||90 Days|The modified full analysis set includes all randomized subjects who received at least one injection using the easypod device and had valid device data. In addition, this total of 35 subjects was divided into 2 groups, Humatrope and Genotropin, based on their previous rhGH use.||Participants|||Number
766866|NCT00689260|Secondary|Subjects Perception of Easypod Ease of Use Compared to Two Other rhGH Pen Injection Devices||90 Days|The modified full analysis set includes all randomized subjects who received at least one injection using the Easypod device and had valid device data. In addition, this total of 35 subjects was divided into 2 groups, Humatrope and Genotropin, based on their previous rhGH use.||Participants|||Number
766867|NCT00689260|Primary|Percent rhGH Injections Missed During the Treatment Period (Based on the Easypod™ Injection Log)||90 Days|The modified full analysis set includes all randomized subjects who received at least one injection using the easypod device and had valid device data. Seven subjects who had damaged devices or incorrect device setting were excluded from this analysis set.||Percent of injections missed||Full Range|Median
766868|NCT00689299|Primary|Scores on a Scale (Average of Total Symptom Scores)|"Sum of individual symptoms scores, 7 items, 21 points maximum
Total Symptom Scores during environmental chamber exposures at week 20. The Total Symptom Score was defined as the sum of the scores from the following seven symptoms rated 0-3 (0=absent, 1=mild, 2= moderate, 3=severe): runny nose, sneezing, itching nose, nasal congestion, watery eyes, itchy eyes, and itchy ears/palate/throat.
Total Symptom score could range from 0-21; the lower the score, the more favorable the outcome. Each symptom parameter was graded by the study subject every 10 minutes for up to 60 minutes during the baseline (Day 0) and during the Week 20 environmental chamber exposures."|20 weeks|Modified Intent to Treat. All subjects with at least 1 symptom assessment during post treatment chamber exposure||Scores on a scale||Standard Deviation|Mean
766869|NCT00689338|Secondary|Time to Successful Intensive Care Unit (ICU) Discharge|Time from start of study medication to successful ICU discharge (by end of treatment [EOT]), defined as being alive on the day after the EOT visit, not being in the ICU on the day after the EOT visit, and being classed as a global treatment success at EOT.|Day 1 up to Day 56|MITT. N = participants who had a successful ICU discharge.||days||95% Confidence Interval|Mean
766872|NCT00689338|Secondary|Percentage of Participants With Global Response Success 6 Weeks After End of Treatment|Global response based on combination of clinical and microbiological outcomes; success defined as clinical response of cure (resolution of signs and symptoms of Candida infection) or improvement (significant, but incomplete resolution of signs and symptoms of Candida infection) in conjunction with microbiological eradication (follow-up culture negative for Candida species) or presumed eradication (follow-up culture not available and clinical response of success).|6 weeks after End of Treatment (Day 14 + 42 up to Day 56 + 42)|MITT; N excludes participants with missing or unknown global responses.||percentage of participants||95% Confidence Interval|Number
766873|NCT00689338|Secondary|Percentage of Participants With Global Response Success at 2 Weeks After End of Treatment|Global response based on combination of clinical and microbiological outcomes; success defined as clinical response of cure (resolution of signs and symptoms of Candida infection) or improvement (significant, but incomplete resolution of signs and symptoms of Candida infection) in conjunction with microbiological eradication (follow-up culture negative for Candida species) or presumed eradication (follow-up culture not available and clinical response of success).|2 weeks after End of Treatment (Day 14 + 14 up to Day 56 + 14)|MITT; N excludes participants with missing or unknown global responses.||percentage of participants||95% Confidence Interval|Number
766874|NCT00689338|Secondary|Percentage of Participants With Global Response Success at End of Intravenous Treatment (EOIVT)|Global response based on combination of clinical and microbiological outcomes; success defined as clinical response of cure (resolution of signs and symptoms of Candida infection) or improvement (significant, but incomplete resolution of signs and symptoms of Candida infection) in conjunction with microbiological eradication (follow-up culture negative for Candida species) or presumed eradication (follow-up culture not available and clinical response of success).|EOIVT (Day 10 up to Day 42)|MITT; N excludes participants with missing or unknown global responses.||percentage of participants||95% Confidence Interval|Number
766875|NCT00689338|Primary|Percentage of Participants With Global Treatment Response Success at End of Treatment|Global response based on combination of clinical and microbiological outcomes; success defined as clinical response of cure (resolution of signs and symptoms of Candida infection) or improvement (significant, but incomplete resolution of signs and symptoms of Candida infection) in conjunction with microbiological eradication (follow-up culture negative for Candida species) or presumed eradication (follow-up culture not available and clinical response of success).|End of Treatment (Day 14 to Day 56)|Modified Intent-To-Treat (MITT) analysis set: all participants in the ITT population with confirmed diagnosis of candidemia or invasive candidiasis, documented within 96 hours prior to initiation of study treatment or 48 hours after commencing treatment. N excludes participants with missing or unknown global responses.||percentage of participants||95% Confidence Interval|Number
766876|NCT00689351|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events: Toddler Dose (12 Months of Age)|Pre-specified systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after toddler dose (12 months of age)|Safety; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the event.||percentage of participants|||Number
766877|NCT00689351|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age)|Pre-specified systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after dose 3 (6 months of age)|Safety; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the event.||percentage of participants|||Number
766878|NCT00689351|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age)|Pre-specified systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after dose 2 (4 months of age)|Safety; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the event.||percentage of participants|||Number
766879|NCT00689351|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age)|Pre-specified systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after dose 1 (2 months of age)|Safety; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the event.||percentage of participants|||Number
766880|NCT00689351|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age)|Pre-specified local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.|Within 4 days after toddler dose (12 months of age)|Safety; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the specific characteristic.||percentage of participants|||Number
766881|NCT00689351|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age)|Pre-specified local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.|Within 4 days after dose 3 (6 months of age)|Safety; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the specific characteristic.||percentage of participants|||Number
766899|NCT00689611|Secondary|Composite Major Adverse Cardiovascular Events (MACE)|"All clinical end points were adjudicated by members of the Endpoints Evaluation Committee who were blinded to treatment assignment.
Composite MACE (death, myocardial infarction, unstable angina)"|12 months|||percentage of participants|||Number
766882|NCT00689351|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age)|Pre-specified local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.|Within 4 days after dose 2 (4 months of age)|Safety; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the specific characteristic.||percentage of participants|||Number
766883|NCT00689351|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age)|Pre-specified local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (greater than [>] 7.0 cm). Participants may be represented in more than 1 category.|Within 4 days after dose 1 (2 months of age)|Safety population: All participants who received at least 1 dose of the study vaccine; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the specific characteristic.||percentage of participants|||Number
766884|NCT00689351|Other Pre-specified|Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Toddler Dose|Antibody GMC along with corresponding 2-sided 95% CI for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Geometric mean concentrations (GMCs) were calculated using all participants with available data for the specified blood draw.|1 month after the Toddler Dose (13 months of age)|Evaluable Toddler Immunogenicity Population||Mcg/mL||95% Confidence Interval|Geometric Mean
766885|NCT00689351|Other Pre-specified|Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Infant Series|Antibody GMC along with corresponding 2-sided 95% CI for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Geometric mean concentrations (GMCs) were calculated using all participants with available data for the specified blood draw.|1 month after the infant series (7 months of age)|Evaluable Infant Immunogenicity Population||Mcg/mL||95% Confidence Interval|Geometric Mean
766886|NCT00689351|Secondary|Percentage of Participants Achieving a Serotype-specific IgG Antibody Level ≥0.35 Mcg/mL Measured 1 Month After the Toddler Dose|Percentage of participants achieving predefined antibody threshold ≥0.35Mcg/mL along with the corresponding 95% CI was calculated for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A). Exact 2-sided CI was based on the observed percentage of participants.|1 month after the toddler dose (13 months of age)|Evaluable Toddler Immunogenicity population:41-99 days old inclusive on day of first vaccination, 365-395 days old inclusive at toddler dose, had all treatments as randomized, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations||percentage of participants||95% Confidence Interval|Number
766887|NCT00689351|Primary|Percentage of Participants Achieving a Serotype-specific Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After the Infant Series|Percentage of participants achieving predefined antibody threshold ≥0.35 Mcg/mL along with the corresponding 95 percent (%) confidence interval (CI) was calculated for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A).|1 month after the infant series (7 months of age)|Evaluable Infant Immunogenicity population: participants who were 41 to 99 days of age (inclusive) on the day of the first vaccination, who had treatments as randomized (all expected doses) and at least 1 valid and determinate assay result for proposed analysis.||percentage of participants||95% Confidence Interval|Number
766888|NCT00689390|Primary|Number of Participants That Discontinued the LTFU Due to SAEs|An SAE was any adverse drug or biologic or device experience occurring at any dose that resulted in any of the following outcomes: death, life-threatening AE, persistent or significant disability/incapacity, required in-patient hospitalization or prolongs hospitalization, congenital anomaly or birth defect. Important medical events that did not result in any of these outcomes could still be considered SAEs if they jeopardized the participant and/or required medical/surgical intervention, based on appropriate medical judgment. Grade 4 laboratory abnormalities and out of normal range liver function tests that were not accompanied by clinical manifestations were NOT considered SAEs.|From enrollment in the LTFU study to the last available date in the LTFU study (up to 3 years)|All enrolled participants were included in safety analyses.||participants|||Number
766889|NCT00689390|Primary|Number of Participants With Serious Adverse Events (SAEs) Reported During the LTFU|Long-term safety was assessed based on the SAEs reported during the LTFU period. An SAE was any adverse drug or biologic or device experience occurring at any dose that resulted in any of the following outcomes: death, life-threatening AE, persistent or significant disability/incapacity, required in-patient hospitalization or prolongs hospitalization, congenital anomaly or birth defect. Important medical events that did not result in any of these outcomes could still be considered SAEs if they jeopardized the participant and/or required medical/surgical intervention, based on appropriate medical judgment. Grade 4 laboratory abnormalities and out of normal range liver function tests that were not accompanied by clinical manifestations were NOT considered SAEs.|From enrollment in the LTFU study to the last available date in the LTFU study (up to 3 years)|All enrolled participants were included in safety analyses.||participants|||Number
766900|NCT00689611|Primary|Smoking Abstinence|"The primary end point was 7-day point prevalence smoking abstinence at 12 months. Smoking cessation was defined as self-reported abstinence in the week before the 12-month clinic visit and a measurement of exhaled carbon monoxide less than 11 ppm.
The primary end point was analyzed on an intention-to-treat (ITT) basis. Our ITT analysis assumed that those who withdrew consent or were lost to follow-up had returned to smoking at their baseline rates. This assumption is common in smoking cessation trials."|12 months|||percentage of participants|||Number
766901|NCT00689793|Secondary|Adherence to Treatment.|Adherence to treatment was calculated as the number of days with at least one opening of the electronic device divided by the total number of monitored days. The device was a MEMS (Medication Event Monitoring System,AARDEX, Europe, Switzerland)|4 weeks|||percentage of day||Standard Deviation|Mean
766890|NCT00689390|Primary|Number of Participants With HCV Treatment-Emergent Resistance Associated Variants (TE-RAVs) of NS3/4A Protease Loci|Plasma samples of all participants receiving at least one dose of study medication in a previous treatment protocol were evaluated by population sequencing and analyzed to detect amino acid variants in the NS3/4A protease known to be associated with reduced susceptibility to boceprevir and narlaprevir. RAVs in the NS3/4A protease gene were evaluated at 12 loci (V36, Q41, F43, T54, V55, V107, R155, A156, V158, D168, I/V170 and M175) on the basis of in vitro studies. A TE-RAV was defined as a RAV not present at baseline and that had not returned to wild type (WT) while the participant was still on treatment. The number of participants with TE-RAVS detected at the EOT in the previous treatment study are reported below, followed by those participants with TE-RAVS that returned to WT during the LTFU (among those with detected TE-RAVS).|From EOT in the previous treatment study to the last available date in the LTFU (up to 3.5 years)|All participants with TE-RAVs who received at least one dose of study medication in a previous Phase 1, 2, or 3 boceprevir or narlaprevir clinical study. Participants could have had more than one TE-RAV. All TE-RAVs were observed in participants in the boceprevir studies (i.e. none of the participants in the narlaprevir study had a TE-RAV).||participants|||Number
766891|NCT00689390|Primary|Kaplan-Meier Exposure-adjusted Relapse Rate|The distribution of time to relapse was summarized using Kaplan-Meier estimates for all participants who were sustained responders at 24 weeks post-treatment in the previous study. Exposure Adjusted Relapse Rate = 1000 × (number of relapses) / (Total exposure time in years). Total exposure time in years = [(total number of days from last day of treatment to the last follow-up day for all subjects who did not relapse) + (total number of days from last day of treatment to the day of relapse for those who relapsed)] / 365.25 days [for 1 year].|From EOT date in the previous treatment study to the first date of a positive HCV RNA result for relapsers or the last contact date for non-relapsers in the LTFU (up to 3.5 years)|All participants who were sustained responders at 24 weeks post-treatment in the previous study and who had available data were included in the analysis.||relapses per 1,000 person-years|||Number
766892|NCT00689390|Primary|Number of Participants With Relapse During the LTFU Among Sustained Responders From Previous Treatment Studies With Boceprevir or Narlaprevir (Durability of Virologic Response)|Durability of response was assessed by the number of participants who relapsed during the LTFU among those that had achieved sustained virologic response (SVR) by 24 weeks after treatment with boceprevir or narlaprevir in a previous Phase 1, 2, or 3 treatment study. In the current LTFU, participants were classified based on the last Hepatitis C Virus ribonucleic acid (HCV-RNA) result available at the time of the data cut-off date as follows: A participant was classified as a sustained virologic responder at a given time point if serum HCV-RNA was undetectable at that time point and there had not been a positive HCV-RNA since the participant was determined to have achieved SVR in the previous study. A participant was classified as a relapser if they were a sustained virologic responder in the previous treatment study and became serum HCV-RNA positive with no subsequent negative results during LTFU.|From End Of Treatment (EOT) date in the previous treatment study to the first date of a positive HCV RNA result for relapsers or the last contact date for non-relapsers in the LTFU (up to 3.5 years)|All participants who were sustained responders at 24 weeks post-treatment in the previous study and who had available data were included in the analysis.||participants|||Number
766893|NCT00689481|Secondary|Number of Subjects Who Have Treatment Success at Week 8 Analyzed by Baseline ISGA (Mild or Moderate)|Assessment (on a scale of 0 to 4) was made as a visual average of all lesions, except those on the face/scalp. 0=clear; minor residual discoloration; no erythema/scaling/plaque thickness (PT). 1=almost clear; occasional fine scale/faint erythema/barely perceptible PT. 2=mild; fine scales predominate; light red coloration/mild PT. 3=moderate; coarse scales predominate; moderate red coloration/moderate PT. 4=severe; thick tenacious scale predominates; deep red coloration/severe PT. Treatment success=ISGA score 0 or 1, and a minimum improvement in the ISGA score of 2 grades from BL to week 8.|8 Weeks|ITT||participants|||Number
766894|NCT00689481|Secondary|Number of Subjects Who Have an ISGA Score of 0 or 1 at Week 8|Assessment (on a scale of 0 to 4) was made as a visual average of all lesions, except those on the face/scalp. 0=clear; minor residual discoloration; no erythema/scaling/plaque thickness (PT). 1=almost clear; occasional fine scale/faint erythema/barely perceptible PT. 2=mild; fine scales predominate; light red coloration/mild PT. 3=moderate; coarse scales predominate; moderate red coloration/moderate PT. 4=severe; thick tenacious scale predominates; deep red coloration/severe PT.|8 Weeks|ITT||participants|||Number
766895|NCT00689481|Secondary|Number of Subjects With a Target Lesion Score of 0 for Plaque Thickness at Week 8|Plaque thickness was assessed on a 6-point scale. 0=no evidence of plaque thickness. 1=barely perceptible plaque thickness, approximately 0.5 millimeters (mm). 2=mild plaque thickness, approximately 1 mm. 3=moderate plaque thickness, approximately 1.5 mm. 4=marked plaque thickness, approximately 2 mm. 5=severe plaque thickness, approximately 2.5 mm or more.|8 Weeks|ITT||participants|||Number
766896|NCT00689481|Secondary|Number of Subjects With a Target Lesion Score of 0 or 1 for Scaling and at Least a 2-grade Improvement From Baseline at Week 8|Scaling was assessed on a 6-point scale. 0=no evidence of scaling. 1=minimal; occasional fine scale over less than 5% of the lesion. 2=mild, fine scales predominate. 3=moderate; course scales predominate. 4=marked; thick non-tenacious scale predominates. 5=severe; very thick tenacious scale predominates.|8 Weeks|ITT||participants|||Number
766897|NCT00689481|Secondary|Number of Subjects With a Target Lesion Score of 0 or 1 for Erythema and at Least a 2-grade Improvement From Baseline at Week 8|Erythema was assessed on a 6-point scale. 0=no evidence of erythema; hyperpigmentation may be present. 1=faint erythema. 2=light red coloration. 3=moderate red coloration. 4=bright red coloration. 5=dusky to deep red coloration.|8 Weeks|ITT||participants|||Number
766898|NCT00689481|Primary|Number of Subjects With Treatment Success, Assessed Per the Investigator's Static Global Assessment|Assessment (on a scale of 0 to 4) was made as a visual average of all lesions, except those on the face/scalp. 0=clear; minor residual discoloration; no erythema/scaling/plaque thickness (PT). 1=almost clear; occasional fine scale/faint erythema/barely perceptible PT. 2=mild; fine scales predominate; light red coloration/mild PT. 3=moderate; coarse scales predominate; moderate red coloration/moderate PT. 4=severe; thick tenacious scale predominates; deep red coloration/severe PT. Treatment success=ISGA score 0 or 1, and a minimum improvement in the ISGA score of 2 grades from BL to week 8.|8 weeks|Intent-to-Treat (ITT) Population||participants|||Number
770375|NCT00711009|Secondary|Mean Change From Baseline in Triglycerides (Micromoles/Liter)|Included in measures of metabolic toxicity|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||micromoles/liter||Standard Deviation|Mean
766902|NCT00689793|Secondary|Response of Iron Supplementation on Mental Disorder|Depression was assessed using the Prime-MD Patient Health Questionnaire (PHQ-9), self-administered by the subject.Diagnosis of depression syndrom was made scoring results of the nine item (range : 0-3). A score >15 (range of total overall scale:0-27) was considered as a depression syndrome. The outcome measure is the number the donors with a depression syndrome at baseline who had a positive response (total score= or <15) after placebo or treatment.|baseline and 4 weeks|Number of participant was set according the primary outcome.||participants|||Number
766903|NCT00689793|Secondary|Aerobic Capacity Using an Indirect Measurement of VO2Max : Chester Step Test|Subjects were asked to step on to and off a 20cm step at a rate set by a metronome. Step rate increased gradually until subject reached her submaximal predicted heart rate.|baseline and 4 weeks|||mLO2/kg/min||Standard Deviation|Mean
766904|NCT00689793|Secondary|Ferritin Change Before and After 4 Weeks of Treatment/Placebo|Level of ferritin measured 4 weeks after randomization|baseline and 4 weeks|||ng/mL||Standard Deviation|Mean
766905|NCT00689793|Secondary|Hemoglobin Variation Before and After Treatment vs Placebo|The level of hemoglobin measured 4 weeks after randomization|baseline and 4 weeks|The number of participants was calculated according to the primary outcome.||g/L||Standard Deviation|Mean
766906|NCT00689793|Primary|Level of Fatigue Before and After Iron Treatment/Placebo, Using a 10 Point Visual Analogue Scale.|"The level of fatigue perceived at baseline and after 4 weeks was scored on a 10-point visual analogue scale ranging from no fatigue=0 to very severe fatigue=10."|baseline and 4 weeks|The sample size for randomized volunteers was calculated using a two-sample comparison of means to detect a one point difference in the visual analogical scale (first outcome).||centimeter||Standard Deviation|Mean
766907|NCT00689819|Secondary|Change in Prevalence of PCCD|To measure the change from baseline to 1 year prevalence of pre-clinical cardiac dysfunction in randomized study patients.|Baseline and 1 year|||percentage of participants|||Number
766908|NCT00689819|Primary|Clinically Significant Difference in Blood Pressure Lowering, Health Status and Quality of Life|To evaluate the ability of this program to produce (as a surrogate for heart failure prevention) a clinically significant difference in blood pressure lowering, health status and quality of life between the 2 treatment groups.|Baseline and 1 year|||mm Hg||95% Confidence Interval|Mean
766909|NCT00689871|Secondary|Satisfaction With Breast Implants as Determined by Patients and Physicians on a 5-point Scale|Satisfaction score on a 5-point scale, where 1 is definitely dissatisfied and 5 is definitely satisfied|10 years|All patients who had a breast implant satisfaction rating||units on a scale||Standard Deviation|Mean
766910|NCT00689871|Primary|Local Complications|By patient risk of complications occuring in at least 5% of patients in 1 or more cohorts|10 years|all enrolled patients||percentage by patient||95% Confidence Interval|Number
766911|NCT00689884|Secondary|Assess the Per-patient Costs Related to Pegfilgrastim Use in the Mobilization of Autologous PBSCs in 16 Study Participants.|Costs will be divided into three categories: 1. Pre-pheresis preparation (cost of Pegfilgrastim, laboratory testing, drug administration, providers, line placement); 2. Pheresis procedure (costs related to # collections and total hours on apheresis machine, microbiological testing, provider, CD34 analysis and related labs, cryopreservation/storage and complications); 3. Post-pheresis processing (cost of stem cell thawing, microbiological testing, CD34 analysis and related labs, providers, administration).|At each stage of pheresis for each enrolled subject for a maximum of 2 years.|Outcome was not reported. The study was terminated for lack of enrollment. Data collection was terminated. No data analysis was performed.|||||
766912|NCT00689884|Primary|Efficacy of Pegfilgrastim in the Mobilization of Autologous Peripheral Blood Stem Cells (PBSCs), Defined as Cell Yield ≥ 3 x 10e6 CD34+/kg|Outcome was not reported. The study was terminated for lack of enrollment. Data collection was terminated. No data analysis was performed.|2 years|Outcome was not reported. The study was terminated for lack of enrollment. Data collection was terminated. No data analysis was performed.|||||
767265|NCT00693303|Primary|Evaluation Tool of Children's Handwriting|This criterion-referenced tool measures a child's legibility and speed in grades one through six. The child writes letters and words, numerals, performs near point and far point copying, writes to dictation, and composes a sentence.|August 2008|||percent of legible letters||Standard Deviation|Mean
766968|NCT00690430|Secondary|Pasireotide LAR vs. Octreotide LAR on Time to Symptom Response.||Month 6|This Outcome Measure was planned in the protocol but not included in the analysis due to early termination of study due to lack of efficacy in symptom control.|||||
767266|NCT00693303|Primary|Legibility Scores on the Evaluation Tool of Children's Handwriting||June 2008 and August 2008||||||
767306|NCT00693992|Other Pre-specified|VEGF Levels and Correlation With Clinical Outcomes, Including RR, PFS, and OS||Up to 6 weeks||||||
766969|NCT00690430|Secondary|Improvement in Daily Mean Number of Flushing Episodes by Randomization Stratum and Treatment.|Percent change from Baseline in total number of flushing episodes comprising Month 6 were compared between the two treatment groups using ANCOVA model with treatment as the main effect and symptom levels at Baseline (e.g. total number of flushing episodes at Baseline) and randomization stratum (D+F or F) as covariates.|6 months|The Efficacy analyzable set consists of the subset of FAS patients who were randomized at least six months prior to the futility DMC data cut-off. Patients were analyzed according the treatment they were assigned to at randomization. (ITT) principle.||Percentage of Episodes||Standard Deviation|Mean
766990|NCT00690573|Secondary|Number of Subjects Positive for Anti-adalimumab Antibodies (AAA)|Serum samples with adalimumab concentration below 2 mcg/mL were selected for AAA analyses. Samples were considered AAA positive if the measured AAA concentration was above 20 ng/mL. A subject was considered to be AAA positive if the subject had at least one AAA positive sample observed within 30 days following the subject's last adalimumab dose.|Week 24 and Week 60|||Participants|||Number
766958|NCT00690040|Secondary|To Compare Mode of Delivery, Catheter's Side Effects and Woman's Satisfaction Between the Groups||At the end of the study||||||
766959|NCT00690040|Primary|Average Time in Hours From Insertion of the Catheter Until Delivery||At the end of the study|||HOURS||Standard Deviation|Mean
766960|NCT00690339|Secondary|Satisfaction With Breast Implants as Determined by Patients and Physicians on a 5-point Scale.|Satisfaction score on a 5-point scale, where 1 is definitely dissatisfied and 5 is definitely satisfied|10 years|All patients who had a breast implant satisfaction rating||units on a scale||Standard Deviation|Mean
766961|NCT00690339|Primary|Local Complications|By patient risk of complications occurring in at least 5% of patients in 1 or more cohorts|10 years|||Percentage of Patients||95% Confidence Interval|Number
766962|NCT00690430|Secondary|Assess the Proportion of Patients Who Achieved at Least a 30% Reduction in Frequency of Bowel Movements||Month 6|This Outcome Measure was planned in the protocol but not included in the analysis due to early termination of study due to lack of efficacy in symptom control.|||||
766963|NCT00690430|Secondary|Pasireotide LAR vs. Octreotide LAR on Duration of Symptom Response||Month 6|This Outcome Measure was planned in the protocol but not included in the analysis due to early termination of study due to lack of efficacy in symptom control.|||||
766964|NCT00690430|Secondary|Pasireotide LAR vs. Octreotide LAR on Time to Symptom Progression||Month 6|This Outcome Measure was planned in the protocol but not included in the analysis due to early termination of study due to lack of efficacy in symptom control.|||||
766965|NCT00690430|Secondary|Pasireotide LAR vs. Octreotide LAR on Quality of Life Assessed by FACIT-D Questionnaire||Month 6|This Outcome Measure was planned in the protocol but not included in the analysis due to early termination of study due to lack of efficacy in symptom control.|||||
766966|NCT00690430|Secondary|Pasireotide LAR vs. Octreotide LAR on Disease Control Rate Based on RECIST Criteria|Disease control rate (DCR) is the proportion of patients with a best overall response of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD). Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters. Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter of all measured target lesions, taking as reference the smallest sum of longest diameter of all target lesions recorded at or after baseline, or a new lesion; or progression of non-target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD. Unknown (UNK) Progression has not been documented and one or more target lesions have not been assessed or have been assessed using a different method than baseline.|Month 6|Full Analysis Set (FAS) consists of all patients randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization. Patients with analyzable data at month 6 were included in this analysis.||Percentage of participants||95% Confidence Interval|Number
766967|NCT00690430|Secondary|Objective Tumor Response Rate Assessed by Investigator|Baseline evaluations were to include Triphasic CT scan or MRI of the abdomen. Triphasic CT or MRIs were to be read by same radiologist at each assessment, measuring the same target and non-target lesions and accounting for all lesions that were present at Baseline. All known disease was accounted for when assessing objective tumor status. Current objective tumor status was to be captured on Tumor Assessment CRF. Objective response rate was defined by RECIST criteria: Partial response (PR) must have ≥ 30% decrease in the sum of longest diameter of all target lesions, from the baseline sum. Complete response (CR) must have disappearance of all target and non-target lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments within 4 weeks. Progression = 20% increase in the sum of longest diameter of all target lesions, from smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions.|Month 6|Full Analysis Set (FAS) consists of all patients randomized into the study. Patients were analyzed according to the treatment they were assigned to at randomization. Patients randomized 6 months before the final clinical cutoff date were included in this analysis.||Percentage of Participants||95% Confidence Interval|Number
766970|NCT00690430|Secondary|Improvement in Daily Mean Number of Diarrhea Bowel Movement Episodes by Randomization Stratum and Treatment.|Percent change from Baseline in mean daily bowel movements at Month 6 were compared between the two treatment groups using ANCOVA model with treatment as the main effect and symptom levels at Baseline (e.g. mean daily bowel movement at Baseline) and randomization stratum (D+F or D) as covariates. Percentage change = (Month 6 - baseline)/baseline.|6 months|The Efficacy analyzable set consists of the subset of FAS patients who were randomized at least six months prior to the futility DMC data cut-off. Patients who had symptoms at baseline and at 6 months were included in this analysis.||Percentage of Episodes||Standard Deviation|Mean
766971|NCT00690430|Primary|Percentage of Patients Who Achieved Clinical Symptom Improvement by Randomization Stratum and Treatment.|Percentage of patients who received clinical benefit in symptom (diarrhea and/or flushing) improvement as: Diarrhea (D)+Flushing (F): Patients with a daily mean number (#) of at least four bowel movements and a total of five or more flushing episodes. Clinical Benefit Response Criteria (CBRC): <4 daily mean bowel movements AND at least 20% reduction from Baseline in the daily mean # of bowel movements AND any reduction in the total # of flushing episodes compared with Baseline. (D) Patients with a daily mean # of at least four bowel movements and a total # of <5 flushing episodes. (CBRC) <4 daily mean bowel movements AND at least a 20% reduction from Baseline in the daily mean # of bowel movements. (F) Patients with a total # of at least 14 flushing episodes and a daily mean # of <4 bowel movements (CBRC) At least a 30% reduction from Baseline in the total # of flushing episodes.|Month 6|The Efficacy analyzable set consists of subset of FAS patients who were randomized at least six months prior to futility interim analysis data cut-off. It is for the primary efficacy analysis and secondary efficacy analysis except for tumor response assessment. Data reported was based on randomized patients at the time of the interim analysis.||Percentage of Participants||95% Confidence Interval|Number
766972|NCT00690443|Secondary|Percent Changes in LDL-C at Week 4 + Baseline Serum Lipoproteins (TC, Non-HDL, VLDL, TGs, HDL-C, Apolopoproteins A1 and B), High Sensitivity C-reactive Protein and Change in Body Weight.||Baseline and 4 weeks|||Percent||Standard Deviation|Mean
766973|NCT00690443|Primary|Percent Change in LDL-C After 8 Weeks of Therapy||Baseline and 8 weeks of treatment|||Percent Change||Standard Deviation|Mean
766974|NCT00690482|Secondary|Adverse Event|The number of participants that experienced at least one adverse event.|Up to 4 Weeks|The safety analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo.||Participants|||Number
766975|NCT00690482|Secondary|Total Use of Reliever|Mean change in Total use of reliever from baseline to treatment period average (calculated using all available data after randomisation for each patient).|Baseline and 4-week treatment period average|The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.||Number of inhalations per day||Full Range|Mean
766976|NCT00690482|Secondary|PEF (Peak Expiratory Flow) Evening|Mean change in PEF evening from baseline to treatment period average (calculated using all available data after randomisation for each patient).|Baseline and 4-week treatment period average|The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.||L/min||Full Range|Mean
766977|NCT00690482|Secondary|PEF (Peak Expiratory Flow) Morning|Mean change in PEF morning from baseline to treatment period average (calculated using all available data after randomisation for each patient).|Baseline and 4-week treatment period average|The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.||L/min||Full Range|Mean
766978|NCT00690482|Secondary|COPD Symptom Sputum Score|Mean change in COPD symptom sputum score from baseline to treatment period average (calculated using all available data after randomisation for each patient). Scores for COPD symptom sputum score range from 0 (none) to 4 (severe).|Baseline and 4-week treatment period average|The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.||Scores on a scale||Full Range|Mean
766979|NCT00690482|Secondary|COPD Symptom Cough Score|Mean change in COPD symptom cough score from baseline to treatment period average (calculated using all available data after randomisation for each patient). Scores for COPD symptom cough score range from 0 (none) to 4 (almost constant).|Baseline and 4-week treatment period average|The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.||Scores on a scale||Full Range|Mean
766980|NCT00690482|Secondary|COPD Symptom Breathing Score|Mean change in COPD symptom breathing score from baseline to treatment period average (calculated using all available data after randomisation for each patient). Scores for COPD symptom breathing score range from 0 (none) to 4 (severe).|Baseline and 4-week treatment period average|The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.||Scores on a scale||Full Range|Mean
766981|NCT00690482|Secondary|COPD Symptom Sleep Score|Mean change in COPD symptom sleep score from baseline to treatment period average (calculated using all available data after randomisation for each patient). Scores for COPD symptom sleep score range from 0 (no symptoms) to 4 (no sleep).|Baseline and 4-week treatment period average|The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.||Scores on a scale||Full Range|Mean
766982|NCT00690482|Secondary|FEF25%-75%|Mean change in FEF25%-75% (forced expiratory flow between 25% and 75% of the FVC) from baseline to Week 4 (last measurement post dose used, if data missing)|Baseline and Week 4|The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.||L/s||Full Range|Mean
766983|NCT00690482|Secondary|Inspiratory Capacity|Mean change in IC from baseline to Week 4 (last measurement post dose used, if data missing)|Baseline and Week 4|The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.||L||Full Range|Mean
767446|NCT00696020|Secondary|Cmax,ss Tiotropium [pg/mL]|Maximum measured concentration of Tiotropium in plasma at steady state (Cmax,ss) after 4 weeks treatment.|Pre-dose, 5 min, 10 min, 20 min, 40 min, 1 h, 3 h, and 6 h after the last dose.|Evaluable patients.||pg/mL||Geometric Coefficient of Variation|Geometric Mean
766991|NCT00690573|Secondary|Mean Serum Adalimumab Concentration|Blood samples were drawn prior to drug administration. Adalimumab concentrations in serum were determined using a validated enzyme-linked immunosorbent assay (ELISA) method based on a double-antigen technique. Concentrations are reported as micrograms per milliliter (mcg/mL).|Week 2, 4, 8, 16, and 24, and every 12 weeks up to Week 60|For the 20 mg dose, N = 8 at each timepoint. For the 40 mg dose, N = 17 at Weeks 2 and 4; N = 16 at Weeks 8, 16, and 24; N = 14 at Week 36; N = 15 at Week 48; and N = 14 at Week 60.||mcg/mL||Standard Deviation|Mean
766992|NCT00690573|Secondary|Number of Subjects Achieving PedACR 30/50/70 Responses||Week 2, 4, 8, and 24, every 12 weeks from Week 24 to Week 60, and every 24 weeks from Week 72 to the final visit|The analysis was conducted using the full analysis set (FAS) population (all subjects who received at least 1 dose of study drug) as observed. N=25 at Weeks 2, 4, and the Final Visit; N=24 at Weeks 8, 24, and 36; N=23 at Week 48; N=22 at Week 60; N=19 at Weeks 72 and 96; N=11 at Week 120; and N=5 at Week 144.||Participants|||Number
766993|NCT00690573|Secondary|Number of Subjects Achieving PedACR50 and PedACR70 Responses at Week 16|Response defined as at least 50/70% improvement in 3 or more of 6 juvenile rheumatoid arthritis (JRA) core set criteria, and at least 50/70% worsening in not more than 1 JRA criterion compared with baseline. JRA core set criteria include physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; number of active joints (joints with swelling or with limitation of motion [LOM] and with pain, tenderness or both); number of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein.|Week 16|The analysis was conducted using the full analysis set (FAS) population, which was defined as all subjects who received at least one dose of study drug. Missing values were treated as non-responders.||Participants|||Number
766994|NCT00690573|Primary|Number of Subjects Achieving Pediatric American College of Rheumatology 30% (PedACR30) Response at Week 16|Response defined as at least 30% improvement in 3 or more of 6 juvenile rheumatoid arthritis (JRA) core set criteria, and at least 30% worsening in not more than 1 JRA criterion, compared with baseline. JRA core set criteria include physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; number of active joints (joints with swelling or with limitation of motion [LOM] and with pain, tenderness or both); number of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein.|Week 16|The analysis was conducted using the full analysis set (FAS) population, which was defined as all subjects who received at least one dose of study drug.||Participants|||Number
766995|NCT00690612|Primary|Mean Change From Baseline to Final Visit in Diastolic Blood Pressure (DBP).|Blood pressure response was defined as Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) less than the 95th percentile based on population height-adjusted charts for age and gender. Response rates were based on the proportion of patients meeting the criteria at each evaluation time point or the last available measure.|every 3 months - baseline to final visit|||mm Hg||Standard Deviation|Mean
766996|NCT00690612|Primary|Mean Change From Baseline to Final Visit in Systolic Blood Pressure (SBP).|Blood pressure response was defined as Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) less than the 95th percentile based on population height-adjusted charts for age and gender. Response rates were based on the proportion of patients meeting the criteria at each evaluation time point or the last available measure.|Every 3 months- baseline to final visit|||Millimeters of Mercury (mm Hg)||Standard Deviation|Mean
766997|NCT00684138|Secondary|Binocular Distance Corrected Intermediate Visual Acuity (Tested at 70 cm)|Binocular Distance Corrected Intermediate Visual Acuity (tested at 70 cm) measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA).|3 months post-operative|Only patients bilaterally implanted with the test article were considered for the outcome measures. One study lens was removed following implantation, but prior to surgery completion, resulting in 279 subjects who were implanted and available for postoperative follow-up (evaluable for All Implanted Analysis).||logMAR||95% Confidence Interval|Mean
766998|NCT00684138|Secondary|Binocular Distance Corrected Intermediate Visual Acuity (Tested at 60 cm)|Binocular Distance Corrected Intermediate Visual Acuity (tested at 60 cm)measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA).|3 months post-operative|Only patients bilaterally implanted with the test article were considered for the outcome measures. One study lens was removed following implantation, but prior to surgery completion, resulting in 279 subjects who were implanted and available for postoperative follow-up (evaluable for All Implanted Analysis).||logMAR||95% Confidence Interval|Mean
766999|NCT00684138|Secondary|Binocular Distance Corrected Intermediate Visual Acuity (Tested at 50 cm)|Binocular Distance Corrected Intermediate Visual Acuity (tested at 50 cm) measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA).|3 months post-operative|Only patients bilaterally implanted with the test article were considered for the outcome measures. One study lens was removed following implantation, but prior to surgery completion, resulting in 279 subjects who were implanted and available for postoperative follow-up (evaluable for All Implanted Analysis).||logMAR||95% Confidence Interval|Mean
767000|NCT00684138|Secondary|Binocular Distance Corrected Distance Visual Acuity|Binocular Distance Corrected Distance Visual Acuity measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA).|3 months post-operative|Only patients bilaterally implanted with the test article were considered for the outcome measures. One study lens was removed following implantation, but prior to surgery completion, resulting in 279 subjects who were implanted and available for postoperative follow-up (evaluable for All Implanted Analysis).||logMAR||95% Confidence Interval|Mean
767001|NCT00684138|Primary|Binocular Distance Corrected Near Visual Acuity at Best Distance (That Which Provides the Subject With the Best Vision)|Binocular Distance Corrected Near Visual Acuity at Best Distance (that which provides the subject with the best vision)measured in mean logMAR. logMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA). Mean logMAR is the average value of visual acuity.|3 months|Only patients bilaterally implanted with the test article were considered for the outcome measures. One study lens was removed following implantation, but prior to surgery completion, resulting in 279 subjects who were implanted and available for postoperative follow-up (evaluable for All Implanted Analysis).||logMAR||95% Confidence Interval|Mean
772191|NCT00732940|Secondary|Absolute Change From Baseline in IgG at Week 24||Baseline, 24 Weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.||g/L||Standard Error|Mean
767002|NCT00684177|Secondary|Number of Participants With Therapeutic Success and Failure at Follow-up (7-9 Days Post Therapy)|"Therapeutic Success (Succ) was referred to as both Clinical Succ and Microbiological (Micro) Succ at Follow-up. Clinical Succ was the Resolution of baseline signs/symptoms of infection with a pus score of 0. A participant was Micro Succ if the micro outcome for all baseline pathogens (bps) belonged to Eradication (elimination of bps), Presumed Eradication (clinical outcome is success; no culturable material), or Colonization (new pathogen is identified at end of therapy in participants who are resolved/improved). All other combinations were deemed Therapeutic Failures."|Follow-up (Days 12-14)|ITTB subset of Primary Efficacy Population||participants|||Number
767003|NCT00684177|Secondary|Number of Baseline Pathogens With the Indicated Microbiological Outcome at End of Therapy (2-4 Days Post Therapy)|"The by pathogen microbiological outcome was determined by comparing the baseline culture results to those at follow-up. The results presented below pooled all baseline pathogens (bps). Eradication: elimination of bps. Presumed Eradication: clinical outcome was success; no culture was obtained due to lack of culturable material. Presumed Improvement: clinical outcome was improvement such that no culture was obtained due to lack of culturable material. Persistence: bps still present. Presumed persistence: clinical failure and no culture was obtained."|Days 7-9|ITTB subset of Primary Efficacy Population||baseline pathogens|||Number
767004|NCT00684177|Secondary|Number of Participants With the Indicated Clinical Outcome at End of Therapy (2-4 Days Post Therapy)|Clinical outcome is determined by the investigator based on signs and symptoms (S/S) at the end of therapy evaluation. The 4 clincal outcome categories are: clinical success, resolution of clinically meaningful S/S of infection recorded at baseline (BL), including a pus/exudates score of 0; clinical improvement, improvement of S/S of infection recorded at BL to such an extent that no further antimicrobial therapy is necessary; clinical failure, insufficient improvement of deterioration of S/S of infection recorded at BL such that additional antibiotic therapy is required; unable to determine.|Days 7-9|Primary Efficacy Population||participants|||Number
767005|NCT00684177|Secondary|Number of Participants With Microbiological Success and Failure at Follow-up (7-9 Days Post Therapy)|"The by pathogen microbiological outcome was determined by comparing the baseline culture results to those at follow-up. The by subject microbiological response was Microbiological Success if the microbiological outcomes for all baseline pathogens (bps) belong to Eradication (elimination of bps), Presumed Eradication (clinical outcome was success; no culture was obtained due to lack of culturable material), or Colonization (previously unidentified pathogen is identified at end of therapy in participant who is resolved/improved); otherwise, response was Microbiological Failure."|Days 12-14|ITTB subset of Primary Efficacy Population||participants|||Number
767006|NCT00684177|Secondary|Number of Participants With Clinical Success and Failure at Follow-up (7-9 Days Post Therapy) for the Intent-to-Treat Bacteriology (ITTB) Subset of the Primary Efficacy Population|"“Clinical Success at follow-up was defined as Resolution of clinically meaningful signs and symptoms of infection recorded at baseline including a pus/exudate Skin Infection Rating Scale (SIRS) score of 0. Clinical response at follow-up was classified as Clinical Failure for all other cases. The SIRS consists of seven items (pus/exudates, crusting, erythema/inflammation, tissue warmth, tissue edema, itching and pain). Each item has a score ranging from 0 to 6 (0=absent, 6=severe). The SIRS total score was calculated as the sum of the scores of all 7 SIRS items."|Days 12-14|ITTB subset of Primary Efficacy Population: participants in the Primary Efficacy Population (see analysis population description in the Primary Outcome section) who had at least one pathogen isolated at the baseline visit.||participants|||Number
767007|NCT00684177|Primary|Number of Participants With Clinical Success and Failure at Follow-up (7-9 Days Post Therapy) for the Primary Efficacy Population|"“Clinical Success at follow-up was defined as Resolution of clinically meaningful signs and symptoms of infection recorded at baseline including a pus/exudate Skin Infection Rating Scale (SIRS) score of 0. Clinical response at follow-up was classified as Clinical Failure for all other cases. The SIRS consists of seven items (pus/exudates, crusting, erythema/inflammation, tissue warmth, tissue edema, itching and pain). Each item has a score ranging from 0 to 6 (0=absent, 6=severe). The SIRS total score was calculated as the sum of the scores of all 7 SIRS items."|Days 12-14|Primary Efficacy Population: ITTC participants (par.) with baseline pus/exudate >=3 who were enrolled under the original protocol with data captured under eCRF V1 and who were enrolled under protocol amendments with data captured under eCRF V2; ITTC (Intent-to-treat Clinical): all randomized par. who received at least one dose of study medication.||participants|||Number
767008|NCT00684203|Secondary|Number of Participants Who Did Not Undergo PCI That Had Clinically Important Bleeding Events|Clinically important bleeding events were defined as intracranial hemorrhage, bleeding requiring blood transfusion, bleeding requiring hospitalization, and TIMI major bleeding. Analysis of data was by loading dose group.|Baseline Up To Day 60|The population consisted of all enrolled participants who received at least 1 dose of study drug, did not undergo PCI, and had bleeding event data available.||Participants|||Number
767009|NCT00684203|Secondary|Mean CD40 Ligand Levels Among Participants Who Did Not Undergo PCI|Participant blood samples were collected at baseline and at the time of hospital discharge to determine the mean serum level of CD40 ligand. Analysis of data was by loading dose group.|Baseline Up To Day 60|The population consisted of all enrolled participants who received at least 1 dose of study drug, did not undergo PCI, and had CD40 ligand data available.||ng/mL||Standard Error|Mean
767010|NCT00684203|Secondary|Median Hs-CRP Levels Among Participants Who Did Not Undergo PCI|Participant blood samples were collected at baseline and at the time of hospital discharge to determine the median serum level of hs-CRP. Analysis of data was by loading dose group.|Baseline Up To Day 60|The population consisted of all enrolled participants who received at least 1 dose of study drug, did not undergo PCI, and had hs-CRP data available.||mg/L||Standard Deviation|Median
767011|NCT00684203|Secondary|Number of Participants Who Did Not Undergo PCI But Had Bleeding Events That Required Subsequent Hospitalization|Bleeding events were evaluated among participants that did not undergo PCI to determine the number of participants who required a subsequent hospitalization. Analysis of data was by loading dose group.|Up to Day 30|The population consisted of all enrolled participants who received at least 1 dose of study drug, did not undergo PCI, and had hospitalization data available.||Participants|||Number
767719|NCT00697593|Primary|Adverse Events, Serious Adverse Events, and Laboratory Data (Haematology and Biochemistry) and Urinalysis|Information on adverse events are displayed in the adverse events section. Information laboratory data and urinalysis findings are displayed individually above|Week 12 / Early Termination||||||
767012|NCT00684203|Secondary|Number of Participants Who Did Not Undergo PCI But Had Bleeding Events That Required Transfusion|Bleeding events were evaluated among participants that did not undergo PCI to determine the number of participants that required blood transfusion. Analysis of data was by loading dose group.|Up to Day 60|The population consisted of all enrolled participants who received at least 1 dose of study drug, did not undergo PCI, and had transfusion data available.||Participants|||Number
767013|NCT00684203|Secondary|Number of Participants Who Did Not Undergo PCI But Had Coronary Artery Bypass Graft (CABG) Who Experienced Bleeding Events|Bleeding events were evaluated up to 10 hours post-CABG among participants who did not undergo PCI.|Up to 10 Hours Post-CABG|Evaluation of the bleeding events associated with CABG occurring after Vorapaxar treatment was not analyzed since only three participants in the non-PCI cohort underwent CABG in this study.|||||
767014|NCT00684203|Secondary|Number of Participants Experiencing Non-MACE AEs Among Participants Who Did Not Undergo PCI|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. MACE events were defined as nonfatal MI, nonfatal stroke, hospitalization due to recurrent ischemia, or urgent coronary revascularization performed ≥ 30 days after administration of the loading dose (Day 1). All MACE events were excluded from this analysis. Analysis of data was by loading dose group.|Up to Day 121|The population consisted of all enrolled participants who received at least 1 dose of study drug, did not undergo PCI, and had non-MACE AE data available.||Participants|||Number
767015|NCT00684203|Secondary|Number of Participants With Major, Minor, and Non-TIMI Bleeding Events Among Participants Who Did Not Undergo PCI|Major TIMI bleeding was defined as any intracranial bleeding (excluding microhemorrhages <10 mm evident only on gradient-echo MRI), clinically overt signs of hemorrhage associated with a drop in hemoglobin of ≥5 g/dL, or fatal bleeding (bleeding that directly results in death within 7 days). Minor TIMI bleeding was defined as any clinically overt bleeding resulting in hemoglobin drop of 3 to <5 g/dL. Non-TIMI bleeding included all bleeding events not covered under Major TIMI bleeding or Minor TIMI bleeding. Analysis of data was by loading dose group.|Up to Day 60|The population consisted of all enrolled participants who received at least 1 dose of study drug, did not undergo PCI, and had TIMI bleeding data available.||Participants|||Number
767016|NCT00684203|Secondary|Number of Participants Who Underwent PCI With Clinically Important Bleeding Events During Treatment and After Hospital Discharge|Clinically important bleeding events were defined as intracranial hemorrhage, bleeding requiring hospitalization, or TIMI major bleeding. Analysis of data was by loading/maintenance dose group.|Up to Day 121|The population included all participants who received at least 1 dose of study drug, underwent PCI, and had bleeding event data.||Participants|||Number
767017|NCT00684203|Secondary|Mean Membrane-Bound P-Selectin Levels Among Participants Who Underwent PCI|Participant blood samples were collected at Baseline and Days 30 and 60 to evaluate the mean level of membrane-bound P-selectin. Membrane-bound P-selectin was measured using flow cytometry and a monoclonal antibody to P-selectin. Intensity levels are reported in arbitrary units 0 (dark) to 1023 (bright). Higher values correspond to greater membrane-bound P-Selectin levels. Analysis of data was by maintenance dose group.|Baseline, Day 30, Day 60|The population included all enrolled participants that received at least 1 dose of study drug and underwent PCI with membrane-bound P-selectin data available.||Arbitrary Units||Standard Error|Mean
767018|NCT00684203|Secondary|Mean CD40 Ligand Levels Among Participants Who Underwent PCI|Participant blood samples were collected at Baseline and Days 30 and 60 to evaluate the mean level of CD40 ligand present. CD40 ligand is a protein primarily found on activated T-cells, with higher levels indicating better immunological health. Analysis of data was by maintenance dose group.|Baseline, Day 30, Day 60|The population included all enrolled participants who received at least 1 dose of study drug and underwent PCI with CD40 ligand data available.||ng/mL||Standard Error|Mean
767019|NCT00684203|Secondary|Median High-Sensitivity C-Reactive Protein (Hs-CRP) Levels Among Participants Who Underwent PCI By Study Visit|Participant blood samples were collected at Baseline and on Days 30 and 60 to evaluate the median level of hs-CRP. hs-CRP is a protein marker in the blood associated with inflammation with higher values indicating a greater degree of inflammation. Analysis of data was by maintenance dose group.|Baseline, Day 30, Day 60|The population included all enrolled participants who received at least 1 dose of study drug and underwent PCI with hs-CRP data available.||mg/L||Inter-Quartile Range|Median
767020|NCT00684203|Secondary|Number of Participants Who Underwent PCI With Inhibition of Platelet Aggregation By Study Visit|Blood samples were collected from participants at Baseline and Days 30, 60, 74, 90, and 121 to determine the extent of inhibition of platelet aggregation induced by thrombin-receptor agonist peptide (TRAP). Analysis of data was by maintenance dose group.|Baseline, Day 30, Day 60, Day 74, Day 90, Day 121|The population consisted of all enrolled participants who received at least 1 dose of study drug and underwent PCI with inhibition of platelet aggregation data available.||Participants|||Number
767021|NCT00684203|Secondary|Number of Participants With Major, Minor, and Non-Thrombolysis in Myocardial Infarction Cooperative Group (TIMI) Bleeding Events Among Participants Who Underwent PCI|Major TIMI bleeding was defined as any intracranial bleeding (excluding microhemorrhages <10 mm evident only on gradient-echo magnetic resonance imaging [MRI]), clinically overt signs of hemorrhage associated with a drop in hemoglobin of ≥5 g/dL, or fatal bleeding (bleeding that directly results in death within 7 days). Minor TIMI bleeding was defined as any clinically overt bleeding resulting in hemoglobin drop of 3 to <5 g/dL. Non-TIMI bleeding included all bleeding events not covered under Major TIMI bleeding or Minor TIMI bleeding. Analysis of data was by maintenance dose group.|Up to Day 60|The population included all enrolled participants who received at least 1 dose of study drug and underwent PCI with TIMI bleeding data available.||Participants|||Number
767022|NCT00684203|Secondary|Number of Participants Experiencing Non-Major Adverse Cardiac Events (MACE) Who Underwent PCI|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. MACE events were defined as nonfatal myocardial infarction (MI), nonfatal stroke, hospitalization due to recurrent ischemia, or urgent coronary revascularization performed ≥ 30 days after administration of the loading dose (Day 1). All MACE events were excluded from this analysis. Analysis of data was by loading/maintenance dose group.|Up to Day 121|The population included all enrolled participants who received at least 1 dose of study drug and underwent PCI with Non-Major MACE data available.||Participants|||Number
767023|NCT00684203|Primary|Number of Participants Experiencing Adverse Events (AEs) Who Underwent Percutaneous Coronary Interventions (PCI)|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug.|Up to Day 60|The population included all enrolled participants who received at least 1 dose of study drug and underwent PCI.||Participants|||Number
767024|NCT00684242|Primary|Change in Cancer Pain Intensity Determined by Edmonton Symptom Assessment Scale (ESAS)|"Changes in cancer pain from baseline to day 15 using ESAS to measure participant responses to 10 common symptoms (pain, fatigue, nausea, depression, anxiety, drowsiness, shortness of breath, appetite, sleep problems, and feeling of well-being). Intensity of symptoms rated on a 0 to 10 scale from 0 no symptom to 10 worst possible symptom."|From baseline to Day 15|One participant was not evaluable for Day 15.||units on a scale|||Number
767025|NCT00684255|Secondary|Progression Free and Overall Survival.|Probability of progression free and overall survival will be measured.|1 year||||||
767026|NCT00684255|Secondary|Immune Reconstitution.|Peripheral blood for immune reconstitution for T-cell, B-cell and NK cells to be obtained for measurement of cell.|1 year||||||
767027|NCT00684255|Secondary|Chimerism|Percentage(%) of mixed and/or complete donor chimerism has been measured at different time points.|1 year||||||
767028|NCT00684255|Primary|Toxicity|Toxicity associated with reduced intensity regimen of fludarabine/busulfan and Campath followed by allogeneic stem cell transplant in patients with medically refractory Systemic Lupus Erythematosus (SLE) or SSc is measured.|1 year||||||
767029|NCT00684307|Secondary|Oral Clearance (CL/F) of AR-H067637XX (Active Metabolite) for C3435T Genotype CC|Oral clearance of AR-H067637XX in subgroup of patients with genotype CC for gene polymorphism ABCB1 C3435T|36 weeks according to protocol|||L/h||Full Range|Median
767030|NCT00684307|Secondary|Oral Clearance (CL/F) of AR-H067637XX (Active Metabolite) for C3435T Genotype TC|Oral clearance of AR-H067637XX in subgroup of patients with genotype TC for gene polymorphism ABCB1 C3435T|36 weeks according to protocol|||L/h||Full Range|Median
767031|NCT00684307|Secondary|Oral Clearance (CL/F) of AR-H067637XX (Active Metabolite) for C3435T Genotype TT|Oral clearance of AR-H067637XX in subgroup of patients with genotype TT for gene polymorphism ABCB1 C3435T|36 weeks according to protocol|||L/h||Full Range|Median
767032|NCT00684307|Secondary|Plasma Concentration of AR-H067637XX (Active Metabolite)|Assessment made on the week 12 visit|12 weeks after baseline according to protocol|||nmol/L||Full Range|Median
767033|NCT00684307|Secondary|Plasma Concentration of AZD0837 (Prodrug)|Assessment made on the week 12 visit|12 weeks after baseline according to protocol|||nmol/L||Full Range|Median
767034|NCT00684307|Secondary|Ecarin Clotting Time (ECT)|Change in Ecarin clotting time (ECT) from baseline to week 12 visit for patients while on study drug (week 12 visit-baseline)|12 weeks according to protocol.(baseline to week 12 visit)|||sec||Full Range|Median
767035|NCT00684307|Secondary|Activated Partial Thromboplastin Time (APTT)|Change in Activated partial thromboplastin time (APTT) from baseline to week 12 visit for VKA naïve patients while on study drug (week 12 visit-baseline)|12 weeks according to protocol.(baseline to week 12 visit)|||sec||Full Range|Median
767036|NCT00684307|Secondary|D-Dimer|Change in D-Dimer values from enrolment to week 12 visit for VKA naïve patients while on study drug (week 12 visit-enrolment)|14 weeks according to protocol.(enrolment to week 12 visit)|||ng/mL||Full Range|Median
767037|NCT00684307|Primary|Bilirubin|Number of patients while on study drug with Bilirubin>=2 times upper limit of normal|36 weeks according to protocol. For patients who discontinued treatment the time frame was <36 weeks. Mean number of weeks was 21 weeks (baseline to end of treatment visit)|||Participants|||Number
767038|NCT00684307|Primary|Alanine Aminotransferase (ALAT)|Number of patients while on study drug with ALAT>=3 times upper limit of normal.l|36 weeks according to protocol. For patients who discontinued treatment the time frame was <36 weeks. Mean number of weeks was 21 weeks (baseline to end of treatment visit)|||Participants|||Number
767039|NCT00684307|Primary|Creatinine|Change in Creatinine values from baseline to week 12 visit for patients while on study drug (week 12 visit-baseline)|12 weeks according to protocol.(baseline to week 12 visit)|||umol/L||Standard Deviation|Mean
767040|NCT00684307|Primary|Bleeding Events|Number of patients with a bleeding event while on study drug. Patients with multiple events are counted once|36 weeks according to protocol. For patients who discontinued treatment the time frame was <36 weeks. Mean number of weeks was 21 weeks (baseline to end of treatment visit)|||Participants|||Number
767041|NCT00684320|Secondary|Social Phobia and Anxiety Inventory|Our primary self-report outcome measure was the Social Phobia and Anxiety Inventory (SPAI; Turner, Beidel, Dancu, & Stanley, 1989), which consists of 45 items assessing the cognitive, behavioral, and somatic dimensions of SP. SPAI scores range from 45 to 315, with higher scores indicating more severe symptoms. This measure has strong psychometric properties (Turner et al., 1989) and has been widely used in previous treatment outcome research in SP (e.g., Clark et al., 2006).|Pre-Treatment, Post-Treatment (after 4 weeks of treatment)|||units on a scale||Standard Deviation|Mean
767042|NCT00684320|Primary|Liebowitz Social Anxiety Scale (LSAS)|Our primary outcome measure was the clinician-administered LSAS (Liebowitz, 1987), a 24-item scale that provides separate scores for fear and avoidance of social interaction and performance situations. LSAS scores range from 0 to 144. The LSAS has strong psychometric properties (Heimberg et al., 1999) and is arguably the gold-standard outcome measure in treatment research in SAD (e.g., Clark et al., 2006; Heimberg et al., 1998). Higher scores indicate more severe symptoms|Pre-Treatment, Post-Treatment (6 weeks)|||units on a scale||Standard Deviation|Mean
767043|NCT00684411|Secondary|Overall Survival|Overall survival is defined as the time from study entry to death or date last known alive.|Participants were followed long-term for survival for the earlier of 6 weeks from the end of treatment or death. Maximum follow-up was 288 days in this study cohort.|The analysis dataset is comprised of disease evaluable participants. One patient was ineligible based on diagnosis of diffuse large B-cell lymphoma.||days||90% Confidence Interval|Median
767104|NCT00684723|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that the drug reaches in the plasma.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.5, 5, 5.5, 6, 7, 8, 10, 14, 18, 24, 36, and 48 hours after drug administration.|||ng/mL||Standard Deviation|Mean
767105|NCT00684749|Secondary|Surgeon Satisfaction With Outcome|Patient completedsurvey regarding outcome|1 Year||||||
767044|NCT00684411|Secondary|Progression-Free Survival|"Progression-free survival based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study or death. Disease progression was assessed per International Workshop Criteria (IWC) [Cheson, et al. JCO 2007].
Per International Working Group response criteria in lymphoma progressive disease (PD) was defined as the appearance of new lesions; the sum of the product of the diameter (SPD) increasing ≥50% from nadir (smallest value seen during trial) in nodal target lesions overall; or, in any single nodal target lesion, a node with a short axis > 10 mm must increase > 50% in greatest transverse diameter or a node with short axis <10mm must increase by at least 50% to at least 15 mm x 15 mm or have a greatest transverse diameter greater than 15 mm."|Disease was evaluated radiologically at baseline, on treatment at weeks 8, 16, 24 and every 12 weeks thereafter, off treatment for 6 weeks or until death, whichever occurs first. Treatment duration was a median of 56 days (range 5-253 days).|The analysis dataset is comprised of disease evaluable participants. One patient was ineligible based on diagnosis of diffuse large B-cell lymphoma.||days||90% Confidence Interval|Median
767045|NCT00684411|Primary|Overall Response Rate|"Overall response rate is defined as the proportion of patients who achieve complete remission (CR), complete remission/unconfirmed (CRu) or partial remission (PR) based on International Workshop Criteria (IWC) [Cheson, et al. JCO 2007].
Per the International Working Group response criteria in lymphoma (Cheson 2007) for target lesions assessed by CT: Complete response (CR): nodes that were greater than 15 mm in greatest transverse diameter at baseline shrank to less than 15 mm in greatest transverse diameter and those that were 11-15 mm in greatest transverse diameter but had a short axis diameter greater than 10 mm had a short axis diameter less than 10mm and a transverse diameter that remained less than 15 mm; partial response (PR) was defined as a decrease in the sum of the product of the diameter of target lesions by more than 50% but not fulfilling criteria for CR. Overall response was defined as CR+PR."|Disease was evaluated radiologically at baseline, weeks 8, 16, 24 and every 12 weeks thereafter on treatment. Treatment duration was a median of 56 days (range 5-253 days).|The analysis dataset is comprised of disease evaluable participants. One patient was ineligible based on diagnosis of diffuse large B-cell lymphoma.||proportion of participants||90% Confidence Interval|Number
767046|NCT00684424|Secondary|Number of Subjects With Change in Response Categories in Medical Outcomes Sleep Scale (MOS-S): Optimal Sleep Subscale|MOS: subject rated questionnaire to assess sleep quality and quantity. Optimal sleep subscale is derived from Sleep Quantity average hours of sleep each night during the past week. Number of subjects with response: YES (Optimal) if sleep quantity was 7 or 8 hours per night, or response = NO (Non-Optimal) if sleep quantity was less than (<) 7 hours per night. Number of participants with shift in response categories from Baseline to Final Visit.|Baseline, Week 16 (Final Visit)|FAS. Abbreviations: BL = Baseline; FV = Final Visit.||participants|||Number
767047|NCT00684424|Secondary|Medical Outcomes Sleep Scale (MOS-S)|MOS-S: subject reported measure with 12 items that assess key constructs of sleep over the past week. Scoring based on 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes:1, no:0). Six(6) and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute.|Baseline, Week 16 (Final Visit )|FAS. A subscale was classified as missing if any of the questions used in the calculation were missing. Abbreviations: BL = Baseline, SOB = short of breath.||scores on scales||Standard Deviation|Mean
767048|NCT00684424|Secondary|Number of Subjects With Categorical Scores on Clinical Global Impression of Change(CGI-C)|CGI-C scale: physician’s global impression of a subject’s clinical condition in terms of change from baseline. Improvement = CGI response of very much improved, much improved, or minimally improved. No Change = CGI response of no change. Worsening = CGI response of very much worse, much worse or minimally worse.|Week 16 (Final Visit)|FAS||participants|||Number
767049|NCT00684424|Secondary|Number of Subjects With Categorical Scores on Clinical Global Impression of Severity (CGI-S)|CGI-S scale: physician’s global impression of a subject’s clinical condition, at baseline in terms of severity. Numerical scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill subjects). Numbers of subjects in each category are presented.|Baseline|FAS||participants|||Number
767050|NCT00684424|Secondary|Change From Baseline to Final Visit in Visual Analog Scale of Anxiety (VAS-A)|Visual Analog Scale of anxiety self assessment: metric measurement (in 2 mm interval) from the visual analog scale; 0 mm = no anxiety, 100 mm = extreme anxiety. Change from Baseline to Final Visit: score at final visit minus score at baseline.|Baseline, Week 16 (Final Visit), Last Observation Carried Forward|FAS; Last observation carried forward (LOCF) method: subject’s last available post-baseline observation was used if data were missing. In this case, data from Visit 2 were carried forward if final visit data were missing.||mm||Standard Deviation|Mean
767051|NCT00684424|Secondary|Visual Analog Scale of Anxiety (VAS-A)|Visual Analog Scale of anxiety self assessment: metric measurement (in 2 mm interval) from the visual analog scale; 0 mm = no anxiety, 100 mm = extreme anxiety at each visit.|Baseline, Week 4, Week 16 (Final Visit), Last Observation Carried Forward|FAS; Last observation carried forward (LOCF) method: subject’s last available post-baseline observation was used if data were missing. In this case, data from Visit 2 were carried forward if final visit data were missing.||mm||Standard Deviation|Mean
767052|NCT00684424|Secondary|Average Dosage of Pregabalin Taken at Baseline and Final Visit|Average doses of pregabalin in milligrams per day (mg/day) taken at baseline and final visit shown by number of participants at each dose.|Baseline, Week 16 (Final Visit )|Safety analysis set.||participants|||Number
767053|NCT00684424|Secondary|Concomitant Drug Treatments|Concomitant drugs treatments (drugs other than, and in addition to study medication): number of subjects who took each concomitant drug during the study (baseline through end of study). World Health Organization (WHO) Drug (v02Q2) coding dictionary applied.|Baseline through Week 16 (Final Visit)|Safety analysis set.||participants|||Number
767106|NCT00684749|Secondary|Patient Satisfaction With Outcome|Patient completed a survey regarding outcome|1 Year||||||
767107|NCT00684749|Primary|Reoperation Rates|Surgeon completed survey|2 years|All patients who were treated in the time period||participants|||Number
767720|NCT00697593|Primary|Urinalysis - Leukocytes Esterase|Urine samples were taken for clinical laboratory testing of the number of participants with or without leukocytes esterase in urine|Week 12 / Early Termination|Safety Population - 3 participants with missing values||participants|||Number
767054|NCT00684424|Secondary|Seizure Freedom: Number of Seizure-free Subjects During the Last 4 Weeks of the Study|Seizure Freedom (responders): subjects with no seizures (partial or other) during the last 4 weeks of the study. Non-responders: subjects with seizures (partial or other)during the last 4 weeks of the study. Subjects, who discontinued less than 4 weeks into the observation period were excluded from analysis. The 4 week period excludes the titration phase of the study. Missing category includes subjects with missing attack date or insufficient length of treatment period.|Week 8 up to Week 16 (Last 4 weeks of the treatment period)|FAS||participants|||Number
767055|NCT00684424|Secondary|Change in 28 Day Partial Seizure Frequency|Change in 28-day partial seizure frequency between the baseline period and treatment period. Baseline period = the 4 weeks (28 days) prior to Baseline visit. Treatment period = last 12 weeks (84 days) of the study (maintenance treatment phase excluding 4-week titration phase). Seizure frequency in baseline period = total number of partial seizures in baseline phase * 28 divided by total number of days in the baseline phase. Seizure frequency in treatment period = total number of partial seizures in maintenance treatment phase * 28 divided by total number of days in maintenance treatment phase.|Baseline through Week 16 (Final Visit )|FAS. Subjects who discontinued less than 4 weeks into the treatment period or with missing date of the attack were excluded from analyses.||number of seizures per 28 days||Standard Deviation|Mean
767056|NCT00684424|Secondary|Antiepileptic Drugs Used in the Past|Antiepileptic drug history: number of subjects who took each class of antiepileptic drug prior to entering the study. Subjects who took more than one antiepileptic drug were counted for each of the drug classes.|Baseline|Safety analysis set: all subjects who received at least 1 dose of study medication.||participants|||Number
767057|NCT00684424|Primary|Responders: Number of Subjects With a 50% or Greater Reduction in Seizure Frequency|Responders: number of subjects with a 50 percent (%) or greater reduction in partial seizure frequency from Baseline to Final visit. Seizure frequency in treatment period = total number of partial seizures in maintenance treatment phase * 28 divided by total number of days in the maintenance treatment phase. Missing category includes subjects with missing attack date, insufficient length of treatment period or no seizures in both baseline and treatment periods. Subjects with zero seizures in the baseline period and some seizures in the treatment period were treated as non-responders.|Baseline through Week 16|Full Analysis Set: all subjects who received at least 1 dose of study drug and had at least 1 efficacy measurement.||participants|||Number
767058|NCT00684515|Secondary|Mean Membrane-Bound P-Selectin Levels By Study Visit|Participant blood samples were collected at Baseline, Day 30, and Day 60 to determine the mean level of membrane-bound p-selectin in the serum. Membrane-bound P-selectin levels reflect the underlying level of inflammation. Intensity levels are reported in arbitrary units 0 (dark) to 1023 (bright). Higher values correspond to greater membrane-bound P-Selectin levels.|Up to Day 60|The population consisted of all enrolled participants that received at least one dose of study drug and had membrane-bound p-selectin data available.||Arbitrary Units||Standard Error|Mean
767059|NCT00684515|Secondary|Mean CD40 Ligand Levels By Study Visit|Participant blood samples were collected to determine the mean serum level of CD40 ligand. CD40 ligand values represent the level of disease activation with a higher level of CD40 ligand indicating a greater underlying risk.|Up to Day 60|The population consisted of all enrolled participants that received at least one dose of study drug and had CD40 ligand data available.||mg/L||Standard Error|Mean
767060|NCT00684515|Secondary|Median High-Sensitivity C-Reactive Protein (Hs-CRP) Levels By Study Visit|Participant blood samples were collected to determine the median serum level of hs-CRP. hs-cRP levels reflect the underlying level of inflammation. The higher the level, the greater the disease burden.|Up to Day 60|The population consisted of all enrolled participants who received at least one dose of study drug and had hs-CRP data available.||mg/L||Standard Deviation|Median
767061|NCT00684515|Secondary|Number of Participants With MACE or Death|The number of participants experiencing major cardiac events or death was evaluated up to Day 121. Major cardiac events were defined as nonfatal stroke, hospitalization due to recurrent ischemia, or urgent coronary revascularization.|Up to Day 121|The population consisted of all enrolled participants that received at least one dose of study drug.||Participants|||Number
767062|NCT00684515|Secondary|Number of Paticipants Experiencing Thrombolysis in Myocardial Infarction (TIMI) Major, Minor, and Non-TIMI Bleeding Events|Major TIMI bleeding was defined as any intracranial bleeding (excluding micohemorrhages <10 mm evident on magnetic resonance imaging [MRI]), clinical over signs of hemorrhge associated with a drop in hemoglobin >=5 g/dL, or fatal bleeding (bleeding that directly results in death within 7 days). Minor TIMI bleeding was defined as any clinically overt bleeding resulting in a hemoglobin drop of 3 to <5 g/dL. Non-TIMI bleeding included all bleeding events not covered under Major TIMI or Minor TIMI bleeding.|Up to Day 60|The population consisted of all enrolled participants that received at least one dose of study drug and had TIMI bleeding data available.||Participants|||Number
767063|NCT00684515|Primary|Number of Participants Experiencing Non-Major Adverse Cardiac Events (Non-MACE)|An adverse event (AE) is any unfavorable and unintended change in the structure, function, or chemistry of the body temporarily associated with study drug administration, whether or not considered related to study drug. MACE events were defined as nonfatal myocardial infarction (MI), nonfatal stroke, hospitalization due to recurrent ischemia, or urgent coronary revascularization. All MACE events were excluded from this analysis.|Up to Day 121|The population consisted of all enrolled participants that received at least one dose of study drug.||Participants|||Number
767064|NCT00684541|Secondary|Social Phobia and Agoraphobia Inventory|Our secondary outcome assessment of social anxiety symptoms was the Social Phobia and Anxiety Inventory (SPAI; Turner, Beidel, Dancu, & Stanley, 1989), a 45-item self-rated measure that assesses the cognitive, behavioral, and somatic dimensions of SAD. SPAI scores range from 45 to 315, with higher scores indicating more severe symptoms. Previous research suggests that the SPAI has sound psychometric properties (e.g., Turner et al., 1989). Internal consistencies for these measures in the current sample were satisfactory.|Pre, Post (6 weeks), Followup (3 months after post-assessment)|||units on a scale||Standard Deviation|Mean
767119|NCT00690820|Secondary|Percentage of Days With no Flatulence.|The percentage of days with no flatulence is calculated from the diary during the treatment period: 100*(number of days with no flatulence/number of days recorded in diary). Higher values indicate a better response.|5 days|The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.||Percentage of days||Standard Deviation|Mean
767065|NCT00684541|Primary|Liebowitz Social Anxiety Scale (LSAS)|Our primary outcome measure was the clinician-administered LSAS (Liebowitz, 1987), a 24-item scale that provides separate scores for fear and avoidance of social interaction and performance situations. LSAS scores range from 0 to 144. The LSAS has strong psychometric properties (Heimberg et al., 1999) and is arguably the gold-standard outcome measure in treatment research in SAD (e.g., Clark et al., 2006; Heimberg et al., 1998). Higher scores indicate more severe symptoms.|Pre, Post (6 weeks), Followup (3 months after post-assessment)|||units on a scale||Standard Deviation|Mean
767066|NCT00684554|Secondary|Prolonged Withdrawal|participants experiencing prolonged withdrawal beyond two days after buprenorphine induction|a) 2 days|participants who initiated induction||participants|||Number
767067|NCT00684554|Primary|The Primary Outcome Will Include a Comparison of the Proportion of Patients Successfully Inducted One Week After the Initial Primary Care Visit.|The primary outcome will include a comparison of the proportion of patients successfully inducted one week after the initial primary care visit. Defined as in treatment, on Buprenorphine and withdrawal free.|one week after initial primary care visit|patients who in initiated induction||participants|||Number
767068|NCT00684567|Secondary|Number of Participants With a Response (Complete Response [CR] + Partial Response [PR]) in Terms of Overall Tumor Response|"CR = measurable lesion disappeared.
PR = total sum of lesions measurable in bidimension decreased by 50% or more on whole and no secondary progression attributable to tumor was noted. No onset of new lesion."|1 year after the start of administration in the concomitant radiotherapy phase|Response rate in terms of tumor response (ratio of CR + PR) in 19 participants was assessed by Efficacy and Safety Evaluation Committee. 19 participants were found to have measurable lesions. Nineteen participants (as opposed to 30 participants) were analyzed because that is how many participants were still alive 1 year after start of therapy.||Participants|||Number
767069|NCT00684567|Secondary|Number of Participants With Progression Free Survival (PFS) for 1 Year|Administration of SCH 52365 was continued until progression was observed (progression was judged by the investigator based on MRI and clinical symptoms).|1 year after the start of admininstration in the concomitant radiotherapy phase|||Participants|||Number
767070|NCT00684567|Primary|Abnormal Changes in Laboratory Test Values With an Incidence of Greater Than or Equal to 20%|Safety was assessed from the start of administration during the concomitant radiotherapy phase until 30 days after the completion of administration of monotherapy.|until 30 days after the completion of administration of monotherapy|||Participants|||Number
767071|NCT00684567|Primary|Adverse Drug Reactions With an Incidence of Greater Than or Equal to 20%|Safety was assessed from the start of administration during the concomitant radiotherapy phase until 30 days after the completion of administration of monotherapy.|until 30 days after the completion of administration of monotherapy|||Participants|||Number
767072|NCT00684567|Primary|Adverse Events With an Incidence of Greater Than or Equal to 20%|Safety was assessed from the start of administration during the concomitant radiotherapy phase until 30 days after the completion of administration of monotherapy. Adverse events were classified under the system organ class using MedDRA-J Version 11.0.|until 30 days after the completion of administration of monotherapy|||Participants|||Number
767073|NCT00684593|Secondary|Median Time to Maximum Plasma Concentration (Tmax) of Navarixin at Day 28|Participant blood samples were collected at 0, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours following oral administration of Navarixin to determine the Mean Tmax at Day 28. Blood samples were not collected from the placebo group to evaluate this endpoint.|Day 28|The population consisted of all participants for which serum samples were available for the determination of Tmax at Day 28.||Hours||Full Range|Median
767074|NCT00684593|Secondary|Mean Terminal Phase Half-life (T1/2) of Navarixin at Day 28|Participant blood samples were collected at 0, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours to determine the mean T1/2 of Navarixin following oral administration at Day 28. Blood samples were not collected from the placebo group to evaluate this endpoint.|Day 28|The population consisted of all enrolled participants for which serum samples were evaluable for T1/2. One participant was excluded due to erroneous blood sample collection relative to Navarixin dosing. An additional 2 participants were excluded from the population because their T1/2 was incalculable.||Hours||Standard Deviation|Mean
767075|NCT00684593|Secondary|Mean Area Under the Plasma Concentration-Time Curve From Time 0-24 Hours (AUC [0-24]) of Navarixin at Day 28|Participant blood samples were collected at 0, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours following oral administration of Navarixin to determine the mean AUC(0-24) at Day 28. Blood samples were not collected from the placebo group to evaluate this endpoint.|Day 28|The population consisted of all enrolled participants for which serum samples were evaluable at Day 28 for AUC (0-24). One participant was excluded due to erroneous blood sample collection relative to Navarixin dosing.||hr*ng/mL||Standard Deviation|Mean
767076|NCT00684593|Secondary|Mean Maximum Plasma Concentration (Cmax) of Navarixin at Day 28|Participant blood samples were collected at 0, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours following oral administration of Navarixin to determine the mean Cmax at Day 28. Blood samples were not collected from the placebo group to evaluate this endpoint.|Day 28|The population consisted of all participants for which serum samples were available for the determination of Cmax at Day 28. One participant was excluded due to erroneous blood sample collection relative to Navarixin dosing.||ng/mL||Standard Deviation|Mean
767077|NCT00684593|Secondary|Number of Participants by Physician's Assessment of Global Improvement (PGA) Score At Day 29|The PGA is a questionnaire that asks the treating physician to rate the participant's signs and symptoms on a scale where 0=worse, 1=unchanged, 2= slight improvement, 3= fair improvement, 4= good improvement, 5= excellent improvement, and 6=cleared, with higher scores indicating better outcomes.|Day 29|The population consisted of all treated participants with follow-up.||Participants|||Number
767078|NCT00684593|Primary|Mean Percent Change From Baseline in the Psoriasis and Activity Severity Index (PASI) Score at Day 29|PASI score is a means to qualify the extent and severity of psoriatic lesions. The total score is calculated as the sum of the extent and severity of lesions on the head, arms, trunk, and legs and the score can range from 0 (no symptoms) to 72 (maximum symptoms).|Baseline and Day 29|The population consisted of all treated participants with follow-up.||Score on a Scale||Standard Deviation|Mean
767120|NCT00690820|Secondary|Stool Frequency|Stool frequency is the average of the daily number of stools recorded during the treatment period. Lower values indicate a better response.|5 days|The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.||Number per day||Standard Deviation|Mean
767079|NCT00684645|Other Pre-specified|Percentage of Participants Responding to Treatment|Response categories for target lesions: Complete response (CR): Disappearance of all target lesions; Partial response (PR): At least a 30% decrease in the sum of the longest dimensions, reference=baseline sum of longest dimensions; Progressive disease (PD): At least a 20% increase in the sum of the longest dimensions, or the appearance of 1 or more new lesions; Stable disease (SD): Not sufficient shrinkage to qualify for PR, not sufficient increase to qualify for PD; Reference for PD and SD: smallest sum of longest dimensions since treatment started.|12 months|All participants||percentage of participants|||Number
767080|NCT00684645|Other Pre-specified|Percentage of Participants With Treatment-emergent Hypertension, by Common Terminology Criteria for Adverse Events (CTCAE) Grade|Sunitinib-induced hypertension: not present at baseline but developed through the study, or if present at baseline increased by more than (>) 20% during the study. Grade 1: Asymptomatic, transient (less than [<]24 hours) increase by >20 millimeters of Mercury (mm Hg) (diastolic) or to >150/100 mm Hg if previously within normal limits (WNL); Grade 2: Recurrent or persistent (>=24 hours) or symptomatic increase by >20 mm Hg (diastolic) or to >150/100 mm Hg if previously WNL; Grade 3: Requiring >1 drug or more intensive therapy than previously; Grade 4: Life-threatening; Grade 5: Death.|Baseline up to 12 months|All participants||percentage of participants|||Number
767081|NCT00684645|Other Pre-specified|Summary of Adverse Events for Participants Who Required Dose Modification|Adverse events (AEs) or treatment-emergent adverse events (TEAEs) were defined as newly occurring or worsening after first dose. Study drug modifications included reduced dose or temporary discontinuation of treatment.|Baseline up to 12 months|Number of participants analyzed = All participants who required dose modification because of an adverse event. The total number of participants may exceed the number of participants analyzed because one participant may have reported more than one adverse event.||participants|||Number
767082|NCT00684645|Primary|Percentage of Participants With Hypertension|Hypertension was defined as follows. Grade 1: Asymptomatic, transient (less than [<]24 hours) increase by >20mm Hg (diastolic) or to >150/100 mm Hg if previously within normal limits (WNL). Grade 2: Recurrent or persistent (24 hours or more) or symptomatic increase by >20 mm Hg (diastolic) or to >150/100 mm Hg if previously WNL. Grade 3: Requiring >1 drug or more intensive therapy than previously. Grade 4: Life-threatening. Grade 5: Death.|Baseline, Week 6, Months 3, 6, 9, 12|FAS. n = number of participants with evaluable data at that time point.||percentage of participants|||Number
767083|NCT00684645|Primary|Percentage of Participants With Hypothyroidism|TSH and FT4 levels were measured and hypothyroidism was defined as a TSH level >5.0 mIU/L at that time point.|Baseline, Months 3, 6, 9, 12|FAS. n = number of participants with evaluable data at that time point.||percentage of participants|||Number
767084|NCT00684645|Primary|Correlation Between Sunitinib-induced Hypertension and Tumor Response to Treatment (OS)|Sunitinib-induced hypertension was determined using blood pressure recorded at each postbaseline visit. Once participants were identified as having sunitinib-induced hypertension, they retained that status at subsequent visits. OS is the time from start of study treatment to death. Hazard ratio represents the relationship between sunitinib-induced hypertension and OS.|Baseline to date of death (up to 12 months)|FAS||participants|||Number
767085|NCT00684645|Primary|Correlation Between Sunitinib-induced Hypertension and Tumor Response to Treatment (PFS)|Sunitinib-induced hypertension was determined using blood pressure recorded at each postbaseline visit. Once participants were identified as having sunitinib-induced hypertension, they retained that status at subsequent visits. PFS is the time from start of study treatment to first documentation of tumor response to treatment. Hazard ratio represents the relationship between sunitinib-induced hypertension and PFS (presence/absence of hypertension).|Baseline to date of first documentation of response to treatment (up to 12 months)|FAS||participants|||Number
767086|NCT00684645|Primary|Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 12|"Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair >50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead. Participants in Not reported category were on study, had no data for this time point."|Month 12|FAS. Percentages based on entire FAS population.||percentage of participants|||Number
767087|NCT00684645|Primary|Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 9|"Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair >50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead. Participants in Not reported category were on study, had no data for this time point."|Month 9|FAS. Percentages based on entire FAS population.||percentage of participants|||Number
767088|NCT00684645|Primary|Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 6|"Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair >50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead. Participants in Not reported category were on study, had no data for this time point."|Month 6|FAS. Percentages based on entire FAS population.||percentage of participants|||Number
767089|NCT00684645|Primary|Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 3|"Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair >50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead. Participants in Not reported category were on study, had no data for this time point."|Month 3|FAS. Percentages based on entire FAS population.||percentage of participants|||Number
767090|NCT00684645|Primary|Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Week 6|"Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair >50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead. Participants in Not reported category were on study, had no data for this time point."|Week 6|FAS. Percentages based on entire FAS population.||percentage of participants|||Number
767091|NCT00684645|Primary|Overall Survival (OS)|OS is the duration from enrollment to death.|Baseline to date of death (up to 12 months)|FAS||months||95% Confidence Interval|Median
767092|NCT00684645|Primary|Progression-free Survival (PFS)|The period from study entry until disease progression, death, or date of last contact.|Baseline to measured progressive disease (up to 12 months)|FAS||months||95% Confidence Interval|Median
767093|NCT00684645|Primary|Percentage of Participants With Objective Response|Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR). CR is defined as the disappearance of all target lesions. PR is defined as at least 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|12 months|Full analysis set (FAS): all participants who received at least one dose of the study medication.||percentage of participants||95% Confidence Interval|Number
767094|NCT00684671|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|A serious adverse event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or is a sign of suspected or confirmed hepatitis A or hepatitis B.|During one month following the administration of the challenge dose|||Subjects|||Number
767095|NCT00684671|Secondary|Number of Subjects With Serious Adverse Events (SAEs) Since the Last Study Visit of the HAB-160 (NCT00603252) Long-term Follow-up Study Considered by the Investigator to Have a Causal Relationship to Primary Vaccination|A serious adverse event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or is a sign of suspected or confirmed hepatitis A or hepatitis B.|Since the last study visit of the primary study long-term follow-up study up to challenge dose administration (1 year)|||Subjects|||Number
767096|NCT00684671|Secondary|Number of Subjects Reporting Unsolicited Symptoms|Unsolicited symptoms = any adverse event (AE) reported in addition to those solicited during the clinical study. Also any “solicited” symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.|During the 31-day follow-up period after the challenge dose.|||Subjects|||Number
767097|NCT00684671|Secondary|Number of Subjects Reporting Solicited Symptoms|Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include fatigue, gastrointestinal symptoms, headache and temperature (above 37 degree Celsius).|During the 4-day follow-up period after the challenge dose.|||Subjects|||Number
767098|NCT00684671|Secondary|Anti-hepatitis A (Anti-HAV) and Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations|Concentrations are given as geometric mean concentration (GMCs) expressed as mIU/mL.|Two weeks and one month after the challenge dose|Analysis was performed on the Log-Term According-to-Protocol (LT ATP) cohort for analysis of immunogenicity.||mIU/mL||95% Confidence Interval|Geometric Mean
767099|NCT00684671|Secondary|Anti-hepatitis A (Anti-HAV) and Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations|Concentrations are given as geometric mean concentration (GMCs) expressed as mIU/mL.|Prior to administration of challenge dose|Analysis was performed on the Long-Term According-to-Protocol (LT ATP) cohort for analysis of immunogenicity.||mIU/mL||95% Confidence Interval|Geometric Mean
767100|NCT00684671|Primary|Number of Subjects With Anamnestic Response to the Challenge Dose for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies|"Anamnestic response was defined as :
for initially seronegative subjects, antibody concentration ≥ 10 Milli-International Units per Milliliter (mIU/mL),
for initially seropositive subjects: antibody concentration at ≥ 4 fold the pre-vaccination antibody concentration."|One month after the challenge dose.|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.||Subjects|||Number
767101|NCT00684671|Primary|Number of Subjects With Anamnestic Response to the Challenge Dose for Anti-hepatitis A (Anti-HAV) Antibodies|"Anamnestic response was defined as:
for initially seronegative subjects, antibody concentration greater than or equal the cut-off [≥ 15 Milli-International Units per Milliliter (mIU/mL)],
for initially seropositive subjects with pre-vaccination antibody, concentration < 100 mIU/mL: antibody concentration at least four times the pre-vaccination antibody concentration,
for initially seropositive subjects with pre-vaccination antibody concentration ≥ 100 mIU/mL: antibody concentration at least two times the pre-vaccination antibody concentration."|One month after the challenge dose.|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.||Subjects|||Number
767102|NCT00684723|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.5, 5, 5.5, 6, 7, 8, 10, 14, 18, 24, 36, and 48 hours after drug administration.|||ng-hr/mL||Standard Deviation|Mean
767103|NCT00684723|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.5, 5, 5.5, 6, 7, 8, 10, 14, 18, 24, 36, and 48 hours after drug administration.|||ng-hr/mL||Standard Deviation|Mean
767721|NCT00697593|Primary|Urinalysis - Nitrite|Urine samples were taken for clinical laboratory testing of the number of participants with or without nitrite in urine|Week 12 / Early Termination|Safety Population - 3 participants with missing values||participants|||Number
767108|NCT00684762|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable cilostazol (reference and test) plasma concentration to the elimination rate constant.|serial pharmacokinetic concentrations were drawn pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12, 16, 24, 36 and 48 hours post-dose.|Plasma concentration data for 26 of the 32 enrolled participants were used in the statistical analysis. Four subjects did not complete the study and none of their collected data was used. Additionally, two subjects had data values that were not used in this analysis.||ng-hr/mL||Standard Deviation|Mean
767109|NCT00684762|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable cilostazol (test and reference) concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic concentrations were drawn pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12, 16, 24, 36 and 48 hours post-dose.|Plasma concentration data for 28 of the 32 enrolled participants were used in the statistical analysis. Four subjects did not complete the study and none of their collected data was used.||ng-hr/mL||Standard Deviation|Mean
767110|NCT00684762|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that cilostazol (test and reference product) reaches in the plasma.|serial pharmacokinetic concentrations were drawn pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12, 16, 24, 36 and 48 hours post-dose.|Plasma concentration data for 28 of the 32 enrolled participants were used in the statistical analysis. Four subjects did not complete the study and none of their collected data was used.||ng/mL||Standard Deviation|Mean
767111|NCT00684814|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]for Zolpidem Tartrate|The area under the zolpidem tartrate plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|serial pharmacokinetic blood samples drawn prior to dosing (hour 0), then 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 4, 5, 6, 8, 10, and 12 hours after dose administration|Plasma concentration data for 31 of 38 participants were used in the statistical analysis. Six subjects dropped from study period I and one subject dropped from study period II.||ng-hr/mL||Standard Deviation|Mean
767112|NCT00684814|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] for Zolpidem Tartrate|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable zolpidem tartrate concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic blood samples drawn prior to dosing (hour 0), and then at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 4, 5, 6, 8, 10, and 12 hours after dose administration|Plasma concentration data for 31 of 38 participants were used in the statistical analysis. Six subjects dropped from study period I and one subject dropped from study period II.||ng-hr/mL||Standard Deviation|Mean
767113|NCT00684814|Primary|Maximum Plasma Concentration (Cmax) for Zolpidem Tartrate|The maximum or peak concentration that zolpidem tartrate reaches in the plasma.|serial pharmacokinetic blood samples drawn prior to dosing (hour 0), and then at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 4, 5, 6, 8, 10, and 12 hours after dose administration|Plasma concentration data for 31 of 38 participants were used in the statistical analysis. Six subjects dropped from study period I and one subject dropped from study period II.||ng/mL||Standard Deviation|Mean
767114|NCT00690755|Primary|Alterations in PKC-zeta mRNA in Vastus Lateralis Skeletal Muscles|All muscle samples obtained by 9/30/07, final date for examination of samples 9/30/08 Muscle dependent ability to diminish blood glucose levels during insulin treatment.|PKC-zeta mRNA levels and aPKC activity in muscle evaluated 40 minutes post-insulin treatment|PKC-zeta mRNA and aPKC activity in vastus lateralis skeletal muscle was measured by analysis of gene expression levels of PKC and measuring them in relative amounts in comparison to control subjects.||arbitrary units/ng rRNA||Standard Error|Mean
767115|NCT00690794|Secondary|Percentage of Patients With Corneal Fluorescein Staining Score = 0|The corneal surface was assessed by the investigator and graded on a scale of 0-3, where 0 = Absent (no staining present) and 3 = Severe (>50% coverage). Percentage of patients with score = 0 at 90 days was calculated by dividing the number of patients with score = 0 by the total number of patients analyzed.|Day 90|Intent-to-treat. All patients who received test article and had at least one on-therapy study visit were evaluable for the intent-to-treat analysis. An Observed Case analysis (OC) was performed for the ITT population.||percentage of patients|||Number
767116|NCT00690794|Primary|Mean Change at Day 90 From Baseline (Day 0) in Ocular Surface Disease Index (OSDI) Score|The OSDI is a 12-question validated questionnaire (resultant overall 0-100 point score) used to measure ocular symptoms, visual function and environmental factors that may affect a patient's vision, where 0 = normal and 100 = severe. The OSDI questionnaire was administered at both visits and completed by the patient with no assistance from the office staff, physician, or anyone else. The baseline OSDI score was subtracted from the 90-day OSDI score and reported as change. A negative number represents a perceived improvement in ocular health.|Baseline, Day 90|Intent-to-treat. All patients who received test article and had at least one on-therapy study visit were evaluable for the intent-to-treat analysis. An Observed Case analysis (OC) was performed for the ITT population.||Units on a scale||Standard Error|Mean
767117|NCT00690820|Secondary|Percentage of Days With no Abdominal Pain.|The percentage of days with no abdominal pain is calculated from the diary during the treatment period: 100*(number of days with no abdominal pain / number of days recorded in diary). Higher values indicate a better response.|5 days|The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.||Percentage of days||Standard Deviation|Mean
767118|NCT00690820|Secondary|Percentage of Days With Formed/Normal Stools.|The percentage of days with formed/normal stools is calculated from the diary during the treatment period: 100*(number of days with formed/normal stools/number of days with any stool). Higher values indicate a better response.|5 days|The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.||Percentage of days||Standard Deviation|Mean
767190|NCT00691938|Secondary|Time to Response|Time to response is defined as the date of the first dose of study drug to the date that all criteria for CR or CRi are fulfilled.|Up to 12 months|Number of participants analyzed are participants that met the criteria for CR or CRi.||days||Full Range|Median
767121|NCT00690820|Secondary|Total Stool Weight (Grams)|Total weight of the stools collected during the stool collection period. Stools were collected on 3 days during the 5 days treatment period. Lower values indicate a better response.|5 days|The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.||Grams||Standard Deviation|Mean
767122|NCT00690820|Secondary|Total Fat Excretion (Grams)|Total amount of fat excreted during the stool collection period. Stools were collected on 3 days during the 5 days treatment period. Lower values indicate a better response.|5 days|The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.||Grams||Standard Deviation|Mean
767123|NCT00690820|Secondary|Coefficient of Nitrogen Absorption (%)|This coefficient is calculated from nitrogen intake and nitrogen excretion : 100*[nitrogen intake-nitrogen excretion]/nitrogen intake. Stools were collected on 3 days during the 5 days treatment period. Higher values indicate a better response.|5 days|The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.||Percentage||Standard Deviation|Mean
767124|NCT00690820|Primary|Coefficient of Fat Absorption (%)|This coefficient is calculated from fat intake and fat excretion : 100*[fat intake-fat excretion]/fat intake. Stools were collected on 3 days during the 5 days treatment period. Higher values indicate a better response.|5 days|The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.||Percentage||Standard Deviation|Mean
767125|NCT00690833|Primary|Investigator Global Assessment at Week 4|The Investigator global assessment at Week 4 is based on an overall scale of 0-4 with 0 being clear and 4 being very severe|Week 4|||units on a scale||Standard Deviation|Mean
767126|NCT00690898|Secondary|Changes in the Global Acromegaly Quality of Life Assessment (AcroQoL) From Baseline|Acromegaly Quality of Life Assessment (AcroQoL) questionnaire response scores range from 0 to 100. Higher scores indicate best possible Quality of Life.|Week 12, 24 and 48|Analysis based on the number (n) of subjects in the ITT population with a valid value.||units on a scale||95% Confidence Interval|Mean
767127|NCT00690898|Secondary|Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Soft Tissue Swelling) From Baseline|The status of clinical signs of acromegaly assessed by an acromegaly symptoms questionnaire (paper form) completed by the patient at each study visit. The scoring for each clinical sign of acromegaly on the questionnaire is from 0 (no symptom) to 8 (severe, incapacitating symptom). The variation (or no variation) in scores indicate whether the clinical sign of acromegaly had improved, worsened or was unchanged.|Week 12, 24 and 48|Analysis based on the number (n) of subjects in the ITT population with a valid value.||percentage of subjects|||Number
767128|NCT00690898|Secondary|Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Headache) From Baseline|The status of clinical signs of acromegaly assessed by an acromegaly symptoms questionnaire (paper form) completed by the patient at each study visit. The scoring for each clinical sign of acromegaly on the questionnaire is from 0 (no symptom) to 8 (severe, incapacitating symptom). The variation (or no variation) in scores indicate whether the clinical sign of acromegaly had improved, worsened or was unchanged.|Week 12, 24 and 48|Analysis based on the number (n) of subjects in the ITT population with a valid value.||percentage of subjects|||Number
767129|NCT00690898|Secondary|Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Fatigue) From Baseline|The status of clinical signs of acromegaly assessed by an acromegaly symptoms questionnaire (paper form) completed by the patient at each study visit. The scoring for each clinical sign of acromegaly on the questionnaire is from 0 (no symptom) to 8 (severe, incapacitating symptom). The variation (or no variation) in scores indicate whether the clinical sign of acromegaly had improved, worsened or was unchanged.|Week 12, 24 and 48|Analysis based on the number (n) of subjects in the ITT population with a valid value.||percentage of subjects|||Number
767130|NCT00690898|Secondary|Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Excessive Perspiration) From Baseline|The status of clinical signs of acromegaly assessed by an acromegaly symptoms questionnaire (paper form) completed by the patient at each study visit. The scoring for each clinical sign of acromegaly on the questionnaire is from 0 (no symptom) to 8 (severe, incapacitating symptom). The variation (or no variation) in scores indicate whether the clinical sign of acromegaly had improved, worsened or was unchanged.|Week 12, 24 and 48|Analysis based on the number (n) of subjects in the ITT population with a valid value.||percentage of subjects|||Number
767131|NCT00690898|Secondary|Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Arthralgia) From Baseline|The status of clinical signs of acromegaly assessed by an acromegaly symptoms questionnaire (paper form) completed by the patient at each study visit. The scoring for each clinical sign of acromegaly on the questionnaire is from 0 (no symptom) to 8 (severe, incapacitating symptom). The variation (or no variation) in scores indicate whether the clinical sign of acromegaly had improved, worsened or was unchanged.|Week 12, 24 and 48|Analysis based on the number (n) of subjects in the ITT population with a valid value.||percentage of subjects|||Number
767132|NCT00690898|Secondary|Change From Baseline to Visit 3, 4 and 5 (Week 12, 24, and 48) of Prolactin Levels||Week 12, 24 and 48|Analysis based on the number (n) of subjects with baseline level between 20 ng/ml and 100 ng/ml in the ITT population with a valid value.||mcg/L||Standard Deviation|Mean
767133|NCT00690898|Secondary|Percent Variation From Baseline to Visit 3, 4 and 5 (Week 12, 24, and 48) of Serum GH Levels.||Week 12, 24, and 48|Analysis based on number (n) of subjects in the Intent to Treat population (ITT) with a valid value.||percentage change||95% Confidence Interval|Mean
767134|NCT00690898|Secondary|Percent Variation From Baseline to Visit 3, 4 and 5 (Week 12, 24, and 48) of IGF-1 Levels||Week 12, 24, and 48|Analysis based on number (n) of patients with a valid value in the intent-to-treat (ITT) population.||percentage change||95% Confidence Interval|Mean
767135|NCT00690898|Secondary|Number of Patients With at Least a 20% Reduction in Tumour Volume From Baseline Volume (Visit 1) to Week 12 (Visit 3) and Week 24 (Visit 4).||Baseline (week 1) to week 12 and week 24|Analysis based on number (n) of subjects in the Intent to Treat population (ITT) with a valid value.||participants|||Number
767307|NCT00693992|Secondary|Grade and Type of Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0|Grade 3 or 4 adverse events which affected more than 5% of participants are summarized by arm.|Duration of study (up to 5 years)|189 participants were evaluable for adverse events.||percentage of participants|||Number
767136|NCT00690898|Primary|Percentage of Patients With Relevant Reduction in Pituitary Tumour Volume (as Measured by MRI) From Baseline Volume (Visit 1) to Week 48 (After 12 Injections at Visit 5)|A blinded, centrally assessed evaluation of all MRIs was performed. A 20% reduction from the volume at Visit 1 was considered to be clinically relevant.|Week 1 and Week 48|Analysis based on intent-to-treat (ITT) population comprised of 89 patients.||percentage of subjects||95% Confidence Interval|Number
767137|NCT00691015|Secondary|Karnofsky Performance Status Performance Status|"100 – Normal; no complaints; no evidence of disease. 90 – Able to carry on normal activity; minor signs or symptoms of disease. 80 – Normal activity with effort; some signs or symptoms of disease. 70 – Cares for self; unable to carry on normal activity or to do active work. 60 – Requires occasional assistance, but is able to care for most of their personal needs.
50 – Requires considerable assistance and frequent medical care. 40 – Disabled; requires special care and assistance. 30 – Severely disabled; hospital admission is indicated although death not imminent.
20 – Very sick; hospital admission necessary; active supportive treatment necessary.
10 – Moribund; fatal processes progressing rapidly. 0 – Dead"|At 90 days after PBSCT|All participants||units on a scale||Full Range|Median
767138|NCT00691015|Secondary|Incidence of Infections, Including Bacterial, Fungal, and Viral Infections (i.e., CMV and EBV Reactivation, Including Post-transplant Lymphoproliferative Disorders)||Within 6 months after PBSCT|All participants||percentage of participants||95% Confidence Interval|Number
767139|NCT00691015|Secondary|Overall Survival.||At 2 years after PBSCT|||percentage of participants||95% Confidence Interval|Number
767140|NCT00691015|Secondary|Time to Engraftment (i.e., Absolute Neutrophil Recovery [ANC > 500/mm³] )||post transplant, up to 4 weeks|All participants||Days||Full Range|Median
767141|NCT00691015|Secondary|Incidence of Chronic GVHD.||Within 2 years after PBSCT|All participants||percentage of participants||95% Confidence Interval|Number
767142|NCT00691015|Primary|Safety, as Defined by Serious Adverse Events and Adverse Events Related to Study Treatment.||Within 6 months after PBSCT|All participants||% of participants with a reported SAE||95% Confidence Interval|Number
767143|NCT00691015|Primary|Severity of Acute Graft-versus-host Disease (GVHD)||Within 100 days after donor peripheral blood stem cell transplantation (PBSCT) as assessed by Glucksberg criteria|The patients that contracted sever acute graph versus host disease (aGVHD) from those who developed aGVHD||% of participants with severe aGVHD||90% Confidence Interval|Number
767144|NCT00691015|Primary|Incidence of Acute Graft-versus-host Disease (GVHD)||Within 100 days after donor peripheral blood stem cell transplantation (PBSCT) as assessed by Glucksberg criteria|||percentage of participants||90% Confidence Interval|Number
767145|NCT00691028|Secondary|Pharmacokinetics Positive- ATI|ATI (antibody to Infliximab) was measured by a modification of an enzyme immunoassay.|54 weeks|||participants|||Number
767146|NCT00691028|Secondary|Pharmacokinetics- Serum Concentration of Infliximab|Serum level of infliximab was measured by enzyme-linked immunosorbent assay (ELISA), using a monoclonal antibody against infliximab. The lowest level of infliximab that could be reliably detected was 0.1 ug/ml.|54 weeks||||||
767147|NCT00691028|Secondary|Change in Modified Total Sharp Score (mTSS) at week54 From Baseline|The mTSS is a measure of change in joint health. Digitized images of radiographs of hands and feet obtained at screening and Week 54 were scored in a blinded manner. Joints were scored for erosions on a scale of 0 (no damage) to 5 and joint space narrowing on a scale of 0 (no damage) to 4. Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 390 [maximal disease]). An increase in mTSS from baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.|baseline and week 54|||score||Inter-Quartile Range|Median
767148|NCT00691028|Secondary|Change From Baseline to Week 54 in HAQ|HAQ: patient’s assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|54 weeks|||units on a scale||Standard Deviation|Mean
767149|NCT00691028|Secondary|Change From Baseline in DAS28|DAS28 is calculated using TJC, SJC erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x log (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity. A negative change score indicates improvement. Total score range:0 to 9.4, higher score indicated more disease activity. DAS28 =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 to 9.4 implied high disease activity and <2.6 implied remission.|baseline and week 54|||units on a scale||Standard Deviation|Mean
767150|NCT00691028|Secondary|CRP Level|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. Normal range of CRP is 0 mg/dL to 0.3 mg/dL. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|54 weeks|||mg/dl||Inter-Quartile Range|Median
767151|NCT00691028|Secondary|Swollen Joint Count (SJC)|The SJC was determined by examination of 66 joints and identifying when swelling was present. The SJC was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1.|54 weeks|||count||Standard Deviation|Mean
767152|NCT00691028|Secondary|Tender Joint Counts (TJC)|The TJC was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The TJC was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.|54 weeks|||count||Standard Deviation|Mean
767153|NCT00691028|Secondary|Percentage of Participants Achieving American College of Rheumatology 20, 50 and 70% Response (ACR20, 50, 70)|ACR 20 (50 or 70) response is a decrease of at least 20% (50% or 70%) in both TJC and SJC and in 3 to 5 assessments (patient's assessment of pain [VAS] with 0, no pain to 100, worst pain; patient's and physician's global assessment of disease activity VAS scales: overall disease activity [0, very well to 100, very poor and 0, no arthritis activity to 100, extremely active, respectively]; [HAQ]: 20-questions on life activities [0, no difficulty to 3, inability to perform a task]; [CRP])|54 weeks|||percentage of participants|||Number
767722|NCT00697593|Primary|Urinalysis - Blood|Urine samples were taken for clinical laboratory testing of the number of participants with or without blood in urine|Week 12 / Early Termination|Safety Population - 3 participants with missing values||participants|||Number
767154|NCT00691028|Primary|Numeric Index of American College of Rheumatology Response (ACR-N, N Shows the Percent Improvement)|The ACR-N index of improvement is the minimum of the following: (1) the percent decrease from baseline in tender joint counts(TJC) or (2) the percent decrease from baseline in swollen joint counts(SJC) or (3) the median percent decrease from baseline for the following: a. Patient’s assessment of pain (visual analog scale (VAS) 0-100, 100 worst pain); b. Patient’s global assessment of disease activity (VAS 0-100); c. Physician’s global assessment of disease activity (VAS 0-100); d. Physical function as measured by the Health Assessment Questionnaire(HAQ)(0-3); e. C-Reactive Protein(CRP) measurement. Higher numbers (maximum:100) indicate more improvement.|baseline and week 54|||percent change||Standard Deviation|Mean
767155|NCT00691652|Secondary|Identity of the Gene Activated by Clofarabine Therapy by Using Genomic DNA and RNA Array Technology||Twice monthly at standard of care visits for 3 months post last cycle of chemotherapy.||||||
767156|NCT00691652|Secondary|Whether Response to Clofarabine Alone or in Combination With Rituximab Correlates With Changes in Global Serum DNA Methylation Index||Duration of the study, up to 1 year.||||||
767157|NCT00691652|Secondary|Whether Clofarabine Acts as an Inhibitor of DNA Methylation Similar to Cladribine by Performing Scientific Correlates||Duration of the study, up to 1 year.||||||
767158|NCT00691652|Secondary|Determine the Safety and Efficacy of Clofarabine in Combination With Rituximab||Duration of the study, up to 1 year.||||||
767159|NCT00691652|Secondary|Determine One-year Progression Free Survival Using the MTD of Clofarabine With Rituximab in Relapsed CD20+NHL||One year after study drug(s) have been given. Duration of study up to 1 year.||||||
767160|NCT00691652|Primary|Estimate Objective Response Rates of Oral Clofarabine in Combination With Rituximab in Relapsed CD20+NHL||Oral Clofarabine x 14 days for up to 8 cycles (1 cycle equals 14 days on drug, 14 days off drug) for a total of up to 224 days AND Rituximab weekly for 4 weeks than monthly for up to 8 cycles on day 1 of cycle||||||
767161|NCT00691652|Primary|The Maximum Tolerated Dose (MTD) of Oral Clofarabine in Adult Patients With Relapsed CD20+ Non-Hodgkin Lymphoma(NHL)|"Initially, 3 patients will be enrolled into a dose level during the dose-escalation portion:
If no patient experiences dose-limiting toxicities during the first 4 weeks, then 3 patients will be enrolled into the next dose level.
If one of the three patients develops dose-limiting toxicities, then 3 additional patients will be enrolled in that cohort. If none of the additional 3 patients experiences dose-limiting toxicities, then further dose-escalation occurs.
If one additional patient experiences dose-limiting toxicities, then the maximum tolerated dose is exceeded."|14 days for up to 8 cycles (1 cycle equals 14 days on drug, 14 days off drug) for a total of up to 224 days|||Number of participants|||Number
767162|NCT00691665|Primary|Mean Percent Change in Instantaneous Total Ocular Symptom Scores (iTOSS) From Baseline|Responses to patient-completed diaries for instantaneous Total Ocular Symptom Scores (iTOSS). TOSS is composed of 3 individual assessments of ocular symptoms (itching/burning, tearing/watering, redness) each of the 3 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 3 assessments are then added together for a composite score (TOSS score), the maximum of which could be 9. Instantaneous scores were assessed at the time of daily dosing.|14 Days minus baseline|||Percent change||Standard Deviation|Mean
767163|NCT00691665|Primary|Mean Percent Change in Reflective Total Ocular Symptom Scores (rTOSS) From Baseline|Responses to patient-completed diaries for reflective Total Ocular Symptom Scores (rTOSS). TOSS is composed of 3 individual assessments of ocular symptoms (itching/burning, tearing/watering, redness) each of the 3 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 3 assessments are then added together for a composite score (TOSS score), the maximum of which could be 9. Reflective scores were assessed from the hour since the last dose of study medication.|14 Days minus baseline|||Percent change||Standard Deviation|Mean
767164|NCT00691665|Primary|Mean Percent Change in Instantaneous Total Nasal Symptom Score (iTNSS) From Baseline|Responses to patient-completed diaries for instantaneous Total Nasal Symptom Scores (iTNSS). TNSS is composed of 4 individual assessments, which included runny nose, itchy nose, stuffy nose, and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are then added together for a composite score (TNSS score), the maximum of which could be 12. Instantaneous scores were assessed at the time of daily dosing.|14 days minus baseline|||Percent change||Standard Deviation|Mean
767165|NCT00691665|Primary|Mean Percent Change in Reflective Total Nasal Symptom Score (rTNSS) From Baseline|Responses to patient-completed diaries for reflective Total Nasal Symptom Scores (rTNSS). TNSS is composed of 4 individual assessments, which included runny nose, itchy nose, stuffy nose, and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are then added together for a composite score (TNSS score), the maximum of which could be 12. Reflective scores were assessed from the hour since the last dose of study medication.|14 Days minus baseline|||Percent change||Standard Deviation|Mean
767166|NCT00691704|Secondary|Duration of Response|The duration of response, defined only among the responders, is measured from start of achieving Partial Response (PR) [first observation of PR before confirmation] to the time of disease progression, with deaths owing to causes other than progression not counted as events, but censored (Durie et al., 2006). Duration of response will be estimated and plotted with the Kaplan-Meier method. The median will be calculated with 95% confidence intervals.|6 years|||months||Full Range|Mean
767167|NCT00691704|Secondary|Time to Progression|Time to progression (TTP) is defined for all patients as the time from initiation of treatment to disease progression with deaths owing to causes other than progression not counted as events, but censored (Durie et al., 2006).|6 years|Subjects who experienced disease progression.||months||Full Range|Mean
767168|NCT00691704|Secondary|Overall Survival|Overall survival is defined as the time from the date of initiation of treatment to the date of death due to any cause. Overall response rate will be estimated with its 80% confidence interval, and the numbers of subjects achieving a sustained complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), or stable disease (SD) will be tabulated. Overall survival will be estimated and plotted with the Kaplan-Meier method. The median will be calculated with 95% confidence intervals.|6 years|Subjects who initiated drug therapy. Eleven patients are still alive as of 2/28/14.||months||Full Range|Mean
772192|NCT00732940|Secondary|Median Percent Change From Baseline in IgA at Week 24||Baseline, 24 weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.||Percentage||Full Range|Median
767169|NCT00691704|Secondary|Time to Response|Time to response will be measured in the population of subjects with a confirmed response as the time from the date of initiation of treatment to the date of the first documentation of a confirmed response. Full restaging was performed at 6, 12, 18, 24, 36, 48, 60, 72 months). Time to response will be estimated and plotted with the Kaplan-Meier method. The median will be calculated with 95% confidence intervals.|6 months|Subjects who responded to drug induction therapy.||months||Full Range|Mean
767170|NCT00691704|Primary|Progression Free Survival|Progression free survival (PFS) is defined for all subjects as the time from the date of initiation of treatment to the date of first documentation of relapse, progression, or death due to any cause. Full restaging was performed at 6, 12, 18, 24, 36, 48, 60, 72 months). PFS survival will be estimated and plotted with the Kaplan-Meier method. The median will be calculated with 95% confidence intervals.|2 years|Subjects enrolled and able to initiate induction therapy.||participants|||Number
767171|NCT00691808|Primary|Treatment Compliance|Subjects were considered compliant if they had taken >70% of possible doses of the study drug.|End of study|||Percentage of Participants||Standard Deviation|Mean
767172|NCT00691808|Primary|Number of Subjects Reporting Adverse Events Leading to Withdrawal||28 days|||Participants|||Number
767173|NCT00691808|Primary|Number of Subjects Reporting at Least One Adverse Event (AE)|An adverse event includes any noxious, pathological, or unintended change in anatomical, physiological, or metabolic functions as indicated by physical signs or symptoms occurring in any phase of the clinical study whether or not associated with the study medication and whether or not considered related to study medication.|28 days|||Participants|||Number
767174|NCT00691808|Secondary|Change From Baseline in Epworth Sleepiness Scale at Day 28|The Epworth Sleepiness Scale is a self-administered questionnaire used to help quantify a subject's level of daytime sleepiness. Subjects recorded their chances of dozing on a scale of 0 to 3, with 0 being no chance and 3 being a high chance. Baseline (Day -1) scores were subtracted from Day 28 scores to obtain score change from baseline.|Day 28|||Units on a scale||Standard Deviation|Mean
767175|NCT00691808|Secondary|Change From Baseline in Pittsburgh Sleep Quality Index at Day 28|The Pittsburgh Sleep Quality Index is a self-rated questionnaire that assesses sleep quality and disturbances. Responses were scored on a scale of 0 to 3 where 3 is the negative extreme. Baseline (Day -1) scores were subtracted from Day 28 scores to obtain score change from baseline.|Day 28|||Units on a scale||Standard Deviation|Mean
767176|NCT00691808|Secondary|Change From Baseline in Memory Assessment Clinics Self-Rating Scale Total Score at Day 28|The subjects were asked to describe their memory ability in a variety of situations of everyday life (a list of 25 questions) using a 5-point scale, with a lower score being a negative assessment. Baseline (Day -1) scores were subtracted from Day 28 scores to obtain score change from baseline.|Day 28|||Units on a scale||Standard Deviation|Mean
767177|NCT00691808|Secondary|Change From Baseline in 15-Word Test: Short-Term Delayed Recall Score at Day 28|Subjects are asked to recall words from the preceding week's 15-Words Test. Baseline (Day -1) scores (scale 0-15, 0 being the worst) were subtracted from Day 28 scores to obtain the score change from baseline.|Day 28|||Number of words||Standard Deviation|Mean
767178|NCT00691808|Primary|Number of Participants Who Were Exposed to LX6171||14 to18 days|||Participants|||Number
767179|NCT00691808|Primary|Number of Participants Who Were Exposed to LX6171||25 to 27 days|||Participants|||Number
767180|NCT00691808|Secondary|Change From Baseline (Day -1) in 15-Words Test: Acquisition Score at Day 28|The 15-Words Test is used to measure verbal learning and memory. Subjects are scored on the number of recognized words on a scale of 0-15, with 0 being the worst and 15 being the best. The baseline (Day -1) score was subtracted from the Day 28 score to obtain the Score Change from Baseline.|Day 28|||Number of words||Standard Deviation|Mean
767181|NCT00691808|Primary|Number of Participants Who Were Exposed to LX6171||≥28 days|||Participants|||Number
767182|NCT00691808|Secondary|Plasma Concentration||Day 28|||ng/mL||Standard Deviation|Mean
767183|NCT00691938|Secondary|Rate of Hematologic Improvement.|"-Hematologic improvement (HI). Includes the following categories:
Erythroid response: Hemoglobin increase by ≥ 1.5 g/dL over baseline in which the pretreatment hemoglobin is < 11 g/dL or reduction of RBC transfusions of at least 4 RBC transfusions / 8 wk compared with the pretreatment transfusion number in the previous 8 weeks.
Platelet response. Absolute increase of > 30 x 10^9/L for patients starting with 20 x 10^9/L or increase from < 20 x 10^9/L to > 20 x 109/L and by at least 100%
Neutrophil response. At least 100% increase and an absolute increase > 0.5 x 109/L for patients with pretreatment neutrophils < 1.0 x 109/L)"|Up to 12 months|||percentage of participants|||Number
767184|NCT00691938|Secondary|Rates of Morphologic Complete Remission With Incomplete Count Recovery (CRi)|Morphologic complete remission with incomplete blood count recovery (CRi): Achievement of all of the criteria for CR except for residual neutropenia (< 1,000/μL) or thrombocytopenia (< 100,000/μL).|Up to 12 months|||percentage of participants|||Number
767185|NCT00691938|Secondary|Overall Survival|Overall survival is defined as the date of first dose of study drug to the date of death from any cause.|Completion of follow-up (median follow-up was 58 months)|||months||Full Range|Median
767186|NCT00691938|Secondary|Event-free Survival|Event-free survival is defined as the interval from the date of first dose of study drug to date of treatment failure, relapse from CR, or death due to any cause.|Completion of follow-up (median follow-up was 58 months)|||days||95% Confidence Interval|Median
767187|NCT00691938|Secondary|Progression-free Survival||Completion of follow-up (median follow-up was 58 months)|Data was not collected for this outcome measure. Progression is very hard to define for MDS and AML and including it as a pre-specified secondary outcome measure in the protocol was an oversight.|||||
767188|NCT00691938|Secondary|Remission Duration|Defined as the first date that all criteria for CR, CRi or HI are fulfilled to the date of treatment failure, relapse from CR, or death due to any cause.|Completion of follow-up (median follow-up was 58 months)|Number of participants analyzed include those participants who met the criteria for CR, CRi, or HI.||days||Full Range|Median
767189|NCT00691938|Secondary|Safety and Tolerability of Regimen as Measured by the Rate of the Most Common Adverse Events Experienced|Adverse events will be assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 3.0.|Up to 13 months after start of treatment|||percentage of participants|||Number
772193|NCT00732940|Secondary|Absolute Change From Baseline in IgA at Week 24||Baseline, 24 Weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.||g/L||Standard Error|Mean
767191|NCT00691938|Secondary|Changes in Quality of Life Scores as Measured by the Function Assessment of Cancer Therapy-Leukemia (FACT-Leu) Version 4|-The FACT-Leu consists of a 27-item compilation of general questions divided into four primary quality of life domains: physical well-being, social/family well being, emotional well-being, and functional well-being along with a 17 item subscale developed specifically for patients with leukemia.|Up to approximately 12 months after start of treatment|Data was not collected for this outcome measure.|||||
767192|NCT00691938|Secondary|Rate of Cytogenetic Complete Remission (CRc)|Cytogenetic complete remission (CRc). A CRc will be defined by the achievement of a CR with reversion to a normal karyotype in a minimum of 20 metaphases analyzed by cytogenetics.|Up to 12 months|||percentage of participants|||Number
767193|NCT00691938|Primary|Phase II: Overall Rate of Morphologic Complete Remission (CR) + Cytogenetic Complete Remission (CRc) + Morphologic Complete Remission With Incomplete Blood Count Recovery (CRi)|"Morphologic complete remission (CR). A CR designation requires that the patient achieve the morphologic leukemia-free state with less than 5% blasts in an aspirate sample with marrow spicules and with a count of at least 200 nucleated cells. There should be no blasts with Auer rods or persistence of extramedullary disease. Patients must also have an absolute neutrophil count of more than 1,000/μLand platelets of 100,000/μL.
Cytogenetic complete remission (CRc). A CRc will be defined by the achievement of a CR with reversion to a normal karyotype in a minimum of 20 metaphases analyzed by cytogenetics.
Morphologic complete remission with incomplete blood count recovery (CRi): Achievement of all of the criteria for CR except for residual neutropenia (< 1,000/μL) or thrombocytopenia (< 100,000/μL)."|Up to 12 months|||percentage of participants|||Number
767194|NCT00691938|Primary|Phase I: Maximum Tolerated Dose (MTD) of LBH589 When Given in Combination With Decitabine||Completion of Phase I enrollment for MTD (approximately 26 months)|After enrolling all Phase I patients in Dose Levels 1-5b, the maximum tolerated dose was not determined. The Phase II portion of the study used the 5b dose level.||mg (level 5b dosing schedule)|||Number
767195|NCT00692003|Primary|Number of Participants Considered Responders as Assessed During the Maintenance Period|The number of participants who were considered responders during the 12 week Maintenance Period (Week 4 to Week 16). A responder was defined as a participant with a decrease from baseline in Primary Generalised Tonic-Clonic Seizures (PGTCS) frequency of >= 50% (i.e. 28-day PGTC seizure frequency in the period from Week 4 to the Week 16 visit compared to Week -8/-4 to randomization at Week 0). Each participant's response to treatment was assessed on the basis of their seizure diaries. The diary was dispensed at the Screening Visit and maintained by the participant (parent/caregiver) through out the titration and maintenance treatment periods until the Early termination Visit at Week 16. Due to early termination of the study by the Sponsor, no formal analyses were conducted.|Baseline (Week -8/-4 to Week 0) and Maintenance Phase (Week 4 to Week 16)|Due to early termination of the study by the Sponsor, no formal analyses were conducted.|||||
767196|NCT00692003|Secondary|Absolute Change From Baseline in 28-day PGTC Seizure Frequency|Absolute Change from Baseline in 28-day PGTC Seizure Frequency was assessed both for the Maintenance Period alone (Week 4 to Week 16) and for the entire double-blind treatment period (Week 0 to Week 16). Due to early termination of the study by the Sponsor, no formal analyses were conducted.|Baseline and up to 16 weeks|Due to early termination of the study by the Sponsor, no formal analyses were conducted.|||||
767197|NCT00692185|Secondary|Anxiety||Measured at Week 8||||||
767198|NCT00692185|Primary|Weight Gain||Measured at Week 8|||lbs||Standard Deviation|Mean
767199|NCT00692198|Secondary|Dyspnea|Change in dyspnea is measured by change in the St George's Respiratory Questionnaire (SGRQ) total score, follow-up value minus baseline value. The SGRQ total score ranges from 0 to 100, with higher values indicating worse dyspnea. The change in score, follow-up value minus baseline value, ranges from -100 to +100, with higher values indicating increase in dyspnea.|Baseline to 1 year|Patients with both the baseline and 1 year SGRQ total score are included||units on a scale||Standard Deviation|Mean
767200|NCT00692198|Secondary|6-minute Walk Distance|Change in distance walked during 6-minute walk test, follow-up value minus baseline value (feet)|Baseline to 1 year|Change in 6 minute walk distance from baseline to 1 year is analyzed for patients with both baseline and 1 year values||feet||Standard Deviation|Mean
767201|NCT00692198|Secondary|Development of Severe Resting Desaturation|Severe resting desaturation is defined as resting room air SpO2 <=88%|Baseline to 1 year|Participants completing the 1 year saturation assessment are analyzed||Participants|||Count of Participants
767202|NCT00692198|Secondary|Depression|Depression is measured by the change in the Hospital Anxiety and Depression Scale (HADS) depression score, follow-up value minus baseline value. The HADS depression score ranges from 0 to 21 with higher values indicating greater depression. The change in score, follow-up minus baseline value, ranges from -21 to +21 with higher values indicating increase in depression|Baseline to 1 year|Patients with both baseline and 1 year values are included||units on a scale||Standard Deviation|Mean
767203|NCT00692198|Secondary|Anxiety|Anxiety is measured by the change in the Hospital Anxiety and Depression Scale (HADS) anxiety score, follow-up value minus baseline value. The HADS anxiety score ranges from 0 to 21 with higher values indicating greater anxiety. The change in score, follow-up minus baseline value, ranges from -21 to +21 with higher values indicating increase in anxiety|Baseline to 1 year|Patients with both the baseline and 1 year values are included; a subset of clinics administered the HADS questionnaire.||units on a scale||Standard Deviation|Mean
767204|NCT00692198|Secondary|Sleep Quality|Sleep quality is measured by the change in the Pittsburgh Sleep Quality Index total score, follow-up value minus baseline value. The Pittsburgh Sleep Quality Index total score ranges from 0 to 21 with higher values indicating worse sleep quality. The change in score, follow-up minus baseline value, ranges from -21 to +21 with higher values indicating worsening in sleep quality.|Baseline to 1 year|Participants with both the baseline and 1 year values are included||units on a scale||Standard Deviation|Mean
767205|NCT00692198|Secondary|General Quality of Life|General quality of life is measured by the change in the physical component summary subscale of the SF-36 quality of life questionnaire, follow-up value minus baseline value. The physical component summary subscale score ranges from 0 to 100 with higher values indicating better physical functioning. The change in score, follow-up minus baseline value, ranges from -100 to +100 with higher values indicating improvement in physical functioning.|Baseline to 1 year|Participants with both the baseline and 1 year values are included; the SF-36 was administered at a subset of clinics||units on a scale||Standard Deviation|Mean
767206|NCT00692198|Secondary|Disease-specific Quality of Life|Disease-specific quality of life is measured by the change in the St George's Respiratory Questionnaire total score, follow-up value minus baseline value. The total score ranges from 0 to 100 with lower score indicating fewer respiratory symptoms. Change in score, follow-up minus baseline may range from -100 to +100, with lower values indicating improvement in disease-specific quality of life.|Baseline to 1 year|Participants with both the baseline and 1 year values are included||units on a scale||Standard Deviation|Mean
767207|NCT00692198|Secondary|Preference-weighted Health-related Quality of Life|Preference-weighted health-related quality of life is measured by change in the Quality of Well-being Scale total daily score, follow-up value minus baseline value. The total daily score ranges from 0 to 1 with higher score indicating more better quality of life. Death is scored 0. Greater change, follow-up minus baseline, indicates improvement in quality of life compared to baseline. Change scores may range from -1 to +1.|Baseline to 1 year|Participants with both the baseline and 1 year values were included||units on a scale||Standard Deviation|Mean
767208|NCT00692198|Secondary|COPD Exacerbation|Rate of all COPD exacerbations|Through study completion. Median follow-up was 11.4 months|||COPD exacerbations per 100 person-years|||Number
767209|NCT00692198|Secondary|Adherence|Adherence is measured by self-reported hours of home oxygen per day|Through study completion. Median follow-up was 18.4 months.|Patients providing at least 1 self-report are included.||hours per day of supplemental oxygen||Standard Deviation|Mean
767210|NCT00692198|Secondary|Health Care Utilization|Health care utilization is measured by the rate of all hospitalizations.|Through study completion. Median follow-up was 18.4 months.|||Hospitalizations per 100 person-years|||Number
767211|NCT00692198|Secondary|Death|The difference between treatment groups in mortality is assessed with a time-to-event analysis by calculation of the between group hazard ratio for death; the statistical significance of the hazard ratio was determined from the log rank test. The uncertainty in the hazard ratio is expressed in the 95% confidence interval on the hazard ratio.|Through study completion. Median follow-up was 41.5 months.|||Deaths/100 person-years|||Number
767212|NCT00692198|Primary|Death or Hospitalization, Whichever Occurs First|The primary outcome event is death or hospitalization, whichever occurs first. The difference between treatment groups on the primary outcome was assessed with a time-to-event analysis by calculation of the between group hazard ratio for the primary composite outcome; the statistical significance of the hazard ratio was determined from the log rank test. The uncertainty in the hazard ratio is expressed in the 95% confidence interval on the hazard ratio.|Through study completion. Median follow-up was 18.4 months.|||Composite events/100 person-years|||Number
767213|NCT00692211|Primary|Colorectal Cancer Screening|Completing fecal blood test within 90 days of enrolling|3 months|||participants|||Number
767214|NCT00692237|Secondary|Ejection Fraction (EF) Defined as the Volume of Blood Ejected With Each Beat Was Measured on Cine-Cardiac Magnetic Resonance (CMR) Images Before and After Three Months Treatment With Sildenafil and Placebo (100 mg/Day).|The volume of blood within a ventricle immediately before a contraction is known as the end-diastolic volume; the volume of blood left in a ventricle at the end of contraction is end-systolic volume. The difference between end-diastolic volume and end-systolic volumes is the volume of blood ejected with each beat. Ejection fraction (Ef) is the fraction of the end-diastolic volume that is ejected with each beat; expressed as percentage of EDV. This is a measure of cardiac performance that can be deteriorated in diabetic cardiomyopathy.|0 and + 3 months|"We included in this analysis all the patients that concluded the study (Sildenafil group = 29; Placebo group = 25).
The 4 randomized patients who discontinued, did not perform the second after-treatment CMR evaluation.
Analysis was per protocol."||Percentage % of volume (delta)||Standard Deviation|Mean
767215|NCT00692237|Primary|Left Ventricular Torsion Defined as Change in Ventricular Mid-wall Rotation (°) Measured by Cine-Cardiac Magnetic Resonance (CMR) Imaging With Tagging, Before and After Three Months of Treatment With Sildenafil and Placebo (100 mg/Day).|Diabetic cardiomyopathy and hypertrophy are characterized by an increase in cardiac torsion Normal value of rotation are < 12°; in hypertrophic heart such values can raise up to 20-25°. A reduction in left ventricular wall rotation is a sign of improvement after removal of known causes of hypertrophy (for example after surgical repair of aortic stenosis). Based on previous studies a reduction of 3 degrees (°) is considered clinically significant.|0 and + 3 months|An overall sample size of 32 subjects (16 for each group) would thus have given a 90% power to detect the specified minimum detectable difference (3°) at a 2-sided significance level of 0.01; 59 patients were enrolled: 29 randomized to Sildenafil and 25 randomized to Placebo completed the trial. Analysis was per primary efficacy outcome (LV-q).||Degree angle (delta)||Standard Deviation|Mean
767216|NCT00692341|Secondary|Unbound Maximum Observed Plasma Concentration (Cmaxu)|Cmaxu is the highest measured unbound plasma concentration during the dosing interval.|0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose|PK concentration population included all participants who were treated and had at least 1 concentration measurement. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
767217|NCT00692341|Secondary|Unbound Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClastu)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClastu) for unbound drug.|0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose|PK parameter analysis population included all participants who were treated and had at least 1 of the PK parameters of interest. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
767218|NCT00692341|Secondary|Unbound Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)u]|AUC (0 - ∞)u = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞) for unbound drug. It is obtained from AUCu (0 - t) plus AUCu (t - ∞).|0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose|PK parameter analysis population included all participants who were treated and had at least 1 of the PK parameters of interest. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
772194|NCT00732940|Secondary|Mean Serum Belimumab Concentration Levels (Pharmacokinetic [PK]) Over 24 Weeks.||Baseline, 24 weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.||µg/mL||Standard Deviation|Mean
767219|NCT00692341|Secondary|Unbound Apparent Volume of Distribution (Vzu/F)|Volume of distribution of unbound drug is defined as the theoretical volume in which the total amount of unbound drug would need to be uniformly distributed to produce the desired plasma concentration of unbound drug. Unbound apparent volume of distribution after oral dose (Vzu/F) is influenced by the oral bioavailability.|0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose|PK parameter analysis population included all participants who were treated and had at least 1 of the PK parameters of interest. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.||L||Geometric Coefficient of Variation|Geometric Mean
767220|NCT00692341|Secondary|Unbound Apparent Oral Clearance (CLu/F)|Clearance of an unbound drug is a measure of the rate at which an unbound drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the oral bioavailability. Unbound drug clearance is a quantitative measure of the rate at which an unbound drug substance is removed from the blood.|0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose|PK parameter analysis population included all participants who were treated and had at least 1 of the PK parameters of interest. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.||mL/min||Geometric Coefficient of Variation|Geometric Mean
767221|NCT00692341|Secondary|Fraction of Unbound Drug (fu)|Fraction of unbound drug (fu) is defined as the ratio of unbound drug concentration to the total drug concentration.|0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose|PK parameter analysis population included all participants who were treated and had at least 1 of the PK parameters of interest. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.||Ratio||Geometric Coefficient of Variation|Geometric Mean
767222|NCT00692341|Secondary|Apparent Volume of Distribution (Vz/F)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the oral bioavailability.|0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose|PK parameter analysis population included all participants who were treated and had at least 1 of the PK parameters of interest.||Liter (L)||Geometric Coefficient of Variation|Geometric Mean
767223|NCT00692341|Secondary|Apparent Oral Clearance (CL/F)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the oral bioavailability. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose|PK parameter analysis population included all participants who were treated and had at least 1 of the PK parameters of interest.||mL/min||Geometric Coefficient of Variation|Geometric Mean
767224|NCT00692341|Secondary|Plasma Elimination Half-life (t1/2)|Plasma elimination half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose|PK parameter analysis population included all participants who were treated and had at least 1 of the PK parameters of interest.||hr||Standard Deviation|Mean
767225|NCT00692341|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose|PK parameter analysis population included all participants who were treated and had at least 1 of the PK parameters of interest.||hr||Full Range|Median
767226|NCT00692341|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).|0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose|PK parameter analysis population included all participants who were treated and had at least 1 of the PK parameters of interest.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
767227|NCT00692341|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose|PK parameter analysis population included all participants who were treated and had at least 1 of the PK parameters of interest.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
767228|NCT00692341|Primary|Maximum Observed Plasma Concentration (Cmax)||0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hours (hrs) post-dose|Pharmacokinetic (PK) concentration population included all participants who were treated and had at least 1 concentration measurement.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
767229|NCT00692406|Primary|Percent Signal Change in fMRI BOLD Signal Between RVIP Task and Control Task in Cuneus (Cun) During Sustained Attention Task on Abstinent Day|Percent signal change in BOLD (Blood Oxygenation Levels Dependent) signal using functional Magnetic Resonance Imaging Signal between RVIP task and control task in Cun following not smoking for 24 hours. Differences in brain activations were considered significant at p<.001.|12.5 minutes of fMRI scanning following 24 hrs smoking abstinence|the reason the number of baseline participants does not match those analyzed is because of drop outs, screen fails, and excessive head motion during scanning.||percentage of signal change||Standard Deviation|Median
767230|NCT00692406|Primary|Percent Signal Change in fMRI BOLD Signal Between RVIP Task and Control Task in Cuneus (Cun) During Sustained Attention Task on Satiated Day|Percent signal change in BOLD (Blood Oxygenation Levels Dependent) signal between RVIP task and control task using functional Magnetic Resonance Imaging Signal in Cun following smoking as usual. Differences in brain activations were considered significant at p<.001.|12.5 minutes of fMRI scanning following smoking as usual|the reason the number of baseline participants does not match those analyzed is because of drop outs, screen fails, and excessive head motion during scanning.||percentage of signal change||Standard Deviation|Mean
767504|NCT00696410|Secondary|Change From Baseline in Serum Isoprostane in Patients With Systolic Heart Failure|Change from baseline in serum isoprostane 10 months after Zn Acetate in patients with systolic heart failure and compared with a single measure in healthy subjects|Baseline (time 0) and 10 months|power calculation using prior studies of the above laboratories.||pg/ml||Inter-Quartile Range|Median
767231|NCT00692406|Primary|Percent Signal Change in fMRI BOLD Signal Between RVIP Task and Control Task in Angular Gyrus (AnG) During Sustained Attention Task on Abstinent Day|Percent signal change in BOLD (Blood Oxygenation Levels Dependent) signal between RVIP task and control task using functional Magnetic Resonance Imaging Signal in AnG following not smoking for 24 hours. Differences in brain activations were considered significant at p<.001.|12.5 minutes of fMRI scanning following 24 hrs smoking abstinence|the reason the number of baseline participants does not match those analyzed is because of drop outs, screen fails, and excessive head motion during scanning.||percentage of signal change||Standard Deviation|Mean
767232|NCT00692406|Primary|Percent Signal Change in fMRI BOLD Signal Between RVIP Task and Control Task in Angular Gyrus (AnG) During Sustained Attention Task on Satiated Day|Percent signal change in BOLD (Blood Oxygenation Levels Dependent) signal using functional Magnetic Resonance Imaging Signal between RVIP task and control task in AnG following smoking as usual. Differences in brain activations were considered significant at p<.001.|12.5 minutes of fMRI scanning following smoking as usual|the reason the number of baseline participants does not match those analyzed is because of drop outs, screen fails, and excessive head motion during scanning.||percentage of signal change||Standard Deviation|Mean
767233|NCT00692406|Primary|Percent Signal Change in fMRI BOLD Signal Between RVIP Task and Control Task in Middle Frontal Gyri (MFG) During Sustained Attention Task on Abstinent Day|Percent signal change in BOLD (Blood Oxygenation Levels Dependent) signal between RVIP task and control task using functional Magnetic Resonance Imaging Signal in MFG following not smoking for 24 hours. Differences in brain activations were considered significant at p<.001.|12.5 minutes of fMRI scanning following 24 hrs smoking abstinence|the reason the number of baseline participants does not match those analyzed is because of drop outs, screen fails, and excessive head motion during scanning.||percentage of signal change||Standard Deviation|Mean
767234|NCT00692406|Primary|Percent Signal Change in fMRI BOLD Signal Between RVIP Task and Control Task in Middle Frontal Gyri (MFG) During Sustained Attention Task on Satiated Day|Percent signal change in BOLD (Blood Oxygenation Levels Dependent) signal between RVIP task and control task using functional Magnetic Resonance Imaging Signal in MFG following smoking as usual. Differences in brain activations were considered significant at p<.001.|12.5 minutes of fMRI scanning following smoking as usual|the reason the number of baseline participants does not match those analyzed is because of drop outs, screen fails, and excessive head motion during scanning.||percentage of signal change||Standard Deviation|Mean
767235|NCT00692406|Primary|Percent Signal Change in fMRI BOLD Signal Between RVIP Task and Control Task in Inferior Frontal Gyri (IFG) During Sustained Attention Task on Abstinent Day|Percent signal change in BOLD (Blood Oxygenation Levels Dependent) signal between RVIP task and control task using functional Magnetic Resonance Imaging Signal in IFG following not smoking for 24 hours. Differences in brain activations were considered significant at p<.001.|12.5 minutes of fMRI scanning following 24 hrs smoking abstinence|the reason the number of baseline participants does not match those analyzed is because of drop outs, screen fails, and excessive head motion during scanning.||percentage of signal change||Standard Deviation|Mean
767236|NCT00692406|Primary|Percent Signal Change in fMRI BOLD Signal Between RVIP Task and Control Task in Inferior Frontal Gyri (IFG) During Sustained Attention Task on Satiated Day|Percent signal change in BOLD (Blood Oxygenation Levels Dependent) signal between RVIP task and control task using functional Magnetic Resonance Imaging Signal in IFG following smoking as usual. Differences in brain activations were considered significant at p<.001.|12.5 minutes of fMRI scanning following smoking as usual|the reason the number of baseline participants does not match those analyzed is because of drop outs, screen fails, and excessive head motion during scanning.||percentage of signal change||Standard Deviation|Mean
767237|NCT00692419|Primary|Change in Pain, Sexual Dysfunction, and Depression Symptoms|The primary outcome of this study is the change in symptom scores during the intervention phase of the study|12 months|change in pain score during intervention period. In adjusted models, we used mixed effects linear regression to compare changes in symptom scores between the two study arms over the duration of the intervention, and to compare symptom scores among individual patients across the observation and intervention phases.||units on a scale||Standard Error|Mean
767238|NCT00692692|Primary|Post-surgical Infeciton|Occurence of infection after surgery|four weekis|36 consented and agreed to participate in study; all 36 were used for analysis for incidence of infeciton||participants|||Number
767239|NCT00692692|Primary|Patient Satisfaction With the Procedure||one year from time of operation||||||
772195|NCT00732940|Primary|Evaluation of the Number of Participants Who Experienced Adverse Events (AEs) During the 24 Week Period.|SEE ALSO ADVERSE EVENTS RESULTS SECTION|Up to 24 weeks|Please see Adverse Events Section||Percentage of participants|||Number
767248|NCT00692913|Secondary|Percent Change From Baseline at Week 52 in Bone-Specific Alkaline Phosphatase|BSAP is a serum biochemical marker of bone formation and measured in micrograms/Liter (mcg/L). The percent change was calculated as: [100 * ((Week 52/Baseline)-1)]. The greater the percent decrease from baseline, the greater the response to therapy.|Baseline and Week 52|Per-Protocol Population: excluded patients due to important deviations from the protocol that may substantially affect the results of the primary efficacy analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
767249|NCT00692913|Secondary|Percent Change From Baseline at Week 52 in N-Telopeptides of Type 1 Collagen to Urine Creatinine Ratio|NTx is a urine biochemical marker of bone resorption and measured in nanomoles (nmol) Bone Collagen Equivalents (BCE)/millimoles (mmol) creatinine. The percent change was calculated as: [100 * ((Week 52/Baseline)-1)]. The greater the percent decrease from baseline, the greater the response to therapy.|Baseline and Week 52|Per-Protocol Population: excluded patients due to important deviations from the protocol that may substantially affect the results of the primary efficacy analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
767250|NCT00692913|Secondary|Falls Per Participant|"Number of falls per participant was measured.
The fall event rate during the study period was defined as the number of adjudicated falls during the study period divided by the total patient-years in the study. Each participant was to be in the study for approximately one year.
In order to guide and standardize all procedures during the fall adjudication process, a Standard Operating Procedure for Fall Adjudication was created by the
SPONSOR and served as a guideline to standardize operational procedures for fall adjudication."|Up to Week 52|Intent-to-Treat (ITT) population included all randomized participants within the treatment group to which they were randomized regardless of whether or not a participant may have dropped out in the base or continued into the extension study.||Number of Falls||Standard Deviation|Mean
767262|NCT00693225|Primary|Percent of Subjects Overall Who Healed, Improved, or Stayed the Same or Worsened After 8 Weeks of Treatment|"After 8 weeks of treatment a follow-up esophagogastroduodenoscopy (EGD) was performed by an endoscopist blinded to the study and subject allocation. The evaluation results were grouped as follows:
LA C esophagitis at baseline: healed = no erosions in the esophagus; improved= LA grades A or B; Same or worse = C or D at follow-up LA D esophagitis at baseline: healed = no erosions in the esophagus; improved=LA grades A, B, or C; Same=LA grade D at follow-up."|8 weeks|||percentage of patients|||Number
767263|NCT00693238|Secondary|Disease Control||20 years after end of radiation||||||
767251|NCT00692913|Secondary|Percent Change From Baseline in Lumbar Spine and Total Hip Bone Mineral Density|Bone Mineral Density (BMD) as measured by Dual Energy X-Ray Absorptiometry (DEXA) and measured in g/cm^2 was obtained at baseline (visit 1) and Week 52 (visit 13) or at early study discontinuation visit. The percent change was calculated as: [100 * ((Week 52/Baseline)-1)]. The greater the percent change from baseline, the greater the response to therapy.|Baseline and Week 52|The FAS population included participants who took at least one dose of study therapy during the entire treatment period of FOSAVANCE 5600 or who were assigned to receive regular care and had data reported at least once post-randomization during the entire study period, and had efficacy measurements during the entire study period.||Percent Change||95% Confidence Interval|Least Squares Mean
767252|NCT00692913|Secondary|Percentage of Participants With Serum Levels of 25-hydroxyvitamin D Below 20 ng/mL at Week 52|"Percentage of participants with serum levels of 25-hydroxyvitamin D below
20 ng/mL after 52 weeks of treatment (6 month extension study) with FOSAVANCE 5600 once weekly versus Referred-Care in postmenopausal women with osteoporosis and at increased risk of falls."|Week 52|The FAS population included participants who took at least one dose of study therapy during the entire treatment period of FOSAVANCE 5600 or who were assigned to receive regular care and had data reported at least once post-randomization during the entire study period, and had efficacy measurements during the entire study period.||Percentage of Participants|||Number
767253|NCT00692913|Secondary|Percent Change From Baseline at Week 26 in Bone-Specific Alkaline Phosphatase|Bone-Specific Alkaline Phosphatase (BSAP) is a serum biochemical marker of bone formation and measured in micrograms/Liter (mcg/L). The percent change was calculated as: [100 * ((Week 26/Baseline)-1)]. The greater the percent decrease from baseline, the greater the response to therapy.|Baseline and Week 26|Per-Protocol Population: excluded participants due to important deviations from the protocol that may substantially affect the results of the primary efficacy analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
767254|NCT00692913|Secondary|Percent Change From Baseline at Week 26 in N-Telopeptides of Type 1 Collagen to Urine Creatinine Ratio|N-Telopeptides of Type 1 Collagen to Urine Creatinine Ratio (NTx) is a urine biochemical marker of bone resorption and measured in nanomoles (nmol) Bone Collagen Equivalents (BCE)/millimoles (mmol) creatinine. The percent change was calculated as: [100 * ((Week 26/Baseline)-1)]. The greater the percent decrease from baseline, the greater the response to therapy.|Baseline and Week 26|Per-Protocol Population: excluded participants due to important deviations from the protocol that may substantially affect the results of the primary efficacy analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
767255|NCT00692913|Primary|Percentage of Participants With Serum Levels of 25-hydroxyvitamin D Below 20 ng/mL at Week 26|"Percentage of participants with serum levels of 25-hydroxyvitamin D below
20 nanograms/milliliter (ng/mL) after 26 weeks of treatment with FOSAVANCE 5600 once weekly versus Referred-Care in postmenopausal women with osteoporosis and at increased risk of falls."|Week 26|"Full Analysis Set Population (FAS) included participants who took at least one dose of study therapy during the entire treatment period of FOSAVANCE 5600 or who were
assigned to receive regular care and had data reported at least once post-randomization during the entire study period, and had efficacy measurements during the entire study period."||Percentage of Participants|||Number
767256|NCT00693017|Secondary|Percentage Change From Baseline in the Monthly Number of Days With Myoclonic Seizures|Percentage Change from Baseline in the monthly number of days with myoclonic seizures was assessed both for the Maintenance Period alone (Week 4 to Week 16) and for the entire double-blind treatment period (Week 0 to Week 16). Due to early termination of the study by the Sponsor, no formal analyses were conducted.|Baseline and up to 16 weeks||||||
767257|NCT00693017|Primary|Number of Participants Considered Responders as Assessed During the Maintenance Period|The number of participants who were considered responders during the 12 week Maintenance Period (Week 4 to Week 16). A responder was defined as a participant with a decrease >= 50% from baseline in the number of days with myoclonic seizures per 28 days (i.e. 28-day myoclonic seizure frequency in Period from Week 4 to the Week 16 visit compared to Week -8 to randomization at Week 0 [Screening/ Baseline Period]). Occurrence of seizures was documented in a seizure diary. The diary was dispensed at the Screening Visit and maintained by the participant (parent/caregiver) and reviewed at each following visit. The diary was completed daily. All seizures except myoclonic seizures were counted individually in the the diary. Due to early termination of the study by the Sponsor, no formal analyses were conducted.|Baseline (Week -8 to Week 0) and Maintenance Period (Week 4 to Week 16)||||||
767258|NCT00693160|Secondary|Cerebrospinal Fluid (CSF) Prostaglandin E2 (PGE2) Concentration|Concentration of prostaglandin E2 (PGE2) in Cerebrospinal fluid (CSF) 2.5 hours post injection of intrathecal ketorolac|2.5 hours|11 Subjects in the Intrathecal Ketorolac group received post study treatment analysis of CSF for PGE2. We were not able to obtain CSF samples in 3 of the subjects post study drug injection.||picograms per milliliter||Standard Deviation|Mean
767259|NCT00693160|Primary|Hyperalgesia|Total Area of hypersensitivity (measured in centimeters) were assessed approximately 24 hours post intrathecal ketorolac injection by the method of using a von Frey filament|24 hours|||centimeters^2||Standard Deviation|Mean
767260|NCT00693225|Secondary|Percent of Subjects With Severe Esophagitis (LA Grade D) Who Healed, Improved, or Stayed the Same After 8 Weeks of Treatment|"After 8 weeks of treatment a follow-up esophagogastroduodenoscopy (EGD) was performed by an endoscopist blinded to the study and subject allocation. The evaluation results were grouped as follows:
LA C esophagitis at baseline: healed = no erosions in the esophagus; improved= LA grades A or B; Same or worse = C or D at follow-up LA D esophagitis at baseline: healed = no erosions in the esophagus; improved=LA grades A, B, or C; Same=LA grade D at follow-up."|8 weeks|16 of the 41 participants in the Omeprazole/sodium bicarbonate AM dose arm were LA Grade D. 14 of the 43 participants in the Omeprazole/sodium bicarbonate PM dose arm were LA Grade D.||percentage of participants|||Number
767261|NCT00693225|Secondary|Percent of Subjects With Moderate Esophagitis (LA Grade C) Who Healed, Improved, or Stayed the Same or Worsened After 8 Weeks of Treatment|"After 8 weeks of treatment a follow-up esophagogastroduodenoscopy (EGD) was performed by an endoscopist blinded to the study and subject allocation. The evaluation results were grouped as follows:
LA C esophagitis at baseline: healed = no erosions in the esophagus; improved= LA grades A or B; Same or worse = C or D at follow-up LA D esophagitis at baseline: healed = no erosions in the esophagus; improved=LA grades A, B, or C; Same=LA grade D at follow-up."|8 weeks|25 of the 41 participants in the Omeprazole/sodium bicarbonate AM dose arm were LA Grade C. 29 of the 43 participants in the Omeprazole/sodium bicarbonate AM dose arm were LA Grade C.||percentage of participants|||Number
767267|NCT00693420|Other Pre-specified|Patient Reported Outcome: Overall Satisfaction With Eyelashes (Single Item) in Terms of Change From Baseline to Week 20 (Post-treatment)|"Overall, how satisfied are you with your eyelashes? Possible Answers on a 5 point scale as follows: (1 - Very Satisfied; 2 - Satisfied; 3 - Neutral; 4 - Unsatisfied; 5 - Very Unsatisfied)"|Baseline to Week 20|Intent to Treat Population||score on a scale||Standard Deviation|Mean
767268|NCT00693420|Secondary|Upper Eyelash Darkness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment)|Darkness was technologically measured in intensity units ranging from 0 (black) - 255 (white)|Baseline to Week 20|Intent to Treat Population||intensity unit||Standard Deviation|Mean
767269|NCT00693420|Secondary|Upper Eyelash Darkness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16|Darkness was technologically measured in intensity units ranging from 0 (black) - 255 (white)|Baseline to Week 16|Intent to Treat Population||intensity unit||Standard Deviation|Mean
767270|NCT00693420|Secondary|Upper Eyelash Thickness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment)|Progressive thickness technologically measured within preset areas of lashes, expressed in pixels as percentage of the area of interest (AOI). 1 pixel is approximately equal to 0.0273 to 0.0274 mm.|Baseline to Week 20|Intent to Treat Population||percentage of AOI (in pixels)||Standard Deviation|Mean
767271|NCT00693420|Primary|Percentage of Participants Experiencing at Least a 1-grade Increase on the Global Eyelash Assessment (GEA) Scale From Baseline to Week 20 (Post-treatment)|The GEA scale is an investigator-graded 4-point ordinal scale of overall eyelash prominence (1 [minimal], 2 [moderate], 3 [marked], 4 [very marked])|Baseline to Week 20|Intent to Treat Population||Percentage of participants|||Number
767272|NCT00693420|Other Pre-specified|Patient Reported Outcome: Overall Satisfaction With Eyelashes (Single Item) in Terms of Change From Baseline to Week 16|"Overall, how satisfied are you with your eyelashes?
Possible Answers on a 5 point scale as follows:
- Very Satisfied
- Satisfied
- Neutral
- Unsatisfied
- Very Unsatisfied"|Baseline to Week 16|Intent to Treat Population||score on a scale||Standard Deviation|Mean
767273|NCT00693420|Secondary|Upper Eyelash Thickness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16|Progressive thickness technologically measured within preset areas of lashes, expressed in pixels as percentage of the area of interest (AOI). 1 pixel is approximately equal to 0.0273 to 0.0274 mm.|Baseline to Week 16|Intent to Treat Population||percentage of AOI (in pixels)||Standard Deviation|Mean
767274|NCT00693420|Secondary|Upper Eyelash Length as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment)|Upper eyelash length technologically measured in millimeters|Baseline to Week 20|Intent to Treat Population||millimeters||Standard Deviation|Mean
767275|NCT00693420|Secondary|Upper Eyelash Length as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16|Upper eyelash length technologically measured in millimeters|Baseline to Week 16|Intent to Treat Population||millimeters||Standard Deviation|Mean
767276|NCT00693420|Primary|Percentage of Participants Experiencing at Least a 1-grade Increase on the Global Eyelash Assessment (GEA) Scale From Baseline to Week 16|The GEA scale is an investigator-graded 4-point ordinal scale of overall eyelash prominence (1 [minimal], 2 [moderate], 3 [marked], 4 [very marked])|Baseline to Week 16|Intent to Treat Population||Percentage of participants|||Number
767277|NCT00693472|Secondary|Part 2: PANSS Total Score at Day 14|The PANSS is a 30-item clinician-rated instrument for assessing the symptoms of schizophrenia. It consists of 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items). Positive symptoms refer to an excess or distortion of normal mental status (e.g., delusions). Negative symptoms represent a diminution or loss of normal functions (e.g., emotional withdrawal). For each item, symptom severity was rated on a 7-point scale, from 0=absent to 6=extreme. The PANSS total score for each participant was calculated as the sum of the rating assigned to each of the 30 PANSS items, and ranged from 0 to 180 with a higher score indicating greater severity of symptoms. Although the PANSS is traditionally scored with a range of 30-210, with a score of absent = 1 (for each item), for this analysis the range was set from 0-180, with a score of absent = 0 (for each item).|Day 14 of Part 2|Efficacy analysis population was defined as participants who received at least one dose of study drug. The study was terminated early by the sponsor due to lack of enrollment. No formal statistical analysis was done due to the very small sample size in this study.||Score on a scale||Standard Deviation|Mean
767278|NCT00693472|Secondary|Part 2: Mean GCI at Day 14|The GCI was administered to assess whether any deterioration is due to akathisia or uncontrolled psychoses. Score on a scale +2 to -2 (+2 represents much improvement, +1 some improvement, 0 no change, -1 some worsening, and -2 much worsening).|Day 14 of Part 2|Efficacy analysis population was defined as participants who received at least one dose of study drug. The study was terminated early by the sponsor due to lack of enrollment. No formal statistical analysis was done due to the very small sample size in this study.||Score on a scale||Standard Deviation|Mean
767279|NCT00693472|Secondary|Part 1: Mean Positive and Negative Symptom Scale for Schizophrenia (PANSS) Total Score at Day 14|"The PANSS is a 30-item clinician-rated instrument for assessing the symptoms of schizophrenia. It consists of 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items). Positive symptoms refer to an excess or distortion of normal mental status (e.g., delusions). Negative symptoms represent a diminution or loss of normal functions (e.g., emotional withdrawal).
For each item, symptom severity was rated on a 7-point scale, from 0=absent to 6=extreme. The PANSS total score for each participant was calculated as the sum of the rating assigned to each of the 30 PANSS items, and ranged from 0 to 180 with a higher score indicating greater severity of symptoms. Although the PANSS is traditionally scored with a range of 30-210, with a score of absent = 1 (for each item), for this analysis the range was set from 0-180, with a score of absent = 0 (for each item)."|Day 14 of Part 1|Efficacy analysis population was defined as participants who received at least one dose of study drug. The study was terminated early by the sponsor due to lack of enrollment. No formal statistical analysis was done due to the very small sample size in this study.||Score on a scale||Standard Deviation|Mean
767308|NCT00693992|Secondary|Percentage of Deterioration in Symptom Progression at 3 Months Using the EORTC LC13 Dyspnea Subscale|The percentage of patients with at least a 10% drop in the EORTC LC13 Dyspnea Subscale score from baseline to 3-months. The difference between groups will be tested using Fisher's exact test.|At 3 months|Patients who completed the EORTC LC13 Dyspnea Subscale at baseline and 3 months were included in this analysis.||percentage of patients|||Number
767280|NCT00693472|Secondary|Part 1: Mean Global Clinical Impression at Day 14|Global clinical impression (GCI) was administered to assess whether any deterioration is due to akathisia or uncontrolled psychoses. Score on a scale +2 to -2 (+2 represents much improvement, +1 some improvement, 0 no change, -1 some worsening, and -2 much worsening).|Day 14 of Part 1|Efficacy analysis population was defined as participants who received at least one dose of study drug. The study was terminated early by the sponsor due to lack of enrollment. No formal statistical analysis was done due to the very small sample size in this study.||Score on a scale||Standard Deviation|Mean
767281|NCT00693472|Primary|Part 2: Number of Participants Who Were Treatment Failures|Incidence of treatment failure is reported as the number of participants who were treatment failures. A treatment failure is defined as the failure to achieve at least a 1 point reduction from baseline in BAS score at 24 to 26 hours following study treatment. The BAS is scored as follows: objective akathisia, subjective awareness of restlessness and subjective distress related to restlessness are rated on a 4-point scale from 0 – 3 and are summed yielding a total score ranging from 0 (no akathisia) to 9 (severe akathisia).|Up to 14 days|Efficacy analysis population was defined as participants who received at least one dose of study drug.||Participants|||Number
767282|NCT00693472|Primary|Part 1: Number of Participants With Akathisia|Incidence of akathisia is reported as the number of participants who experienced akathisia. Akathisia is defined as a score of 3 on the Barnes akathisia scale (BAS) for 3 consecutive intervals or an akathisia score (BAS) of ≥4 for any single day, or the use of a rescue medication within 13 days of initiating treatment with haloperidol and preladenant. The BAS is scored as follows: objective akathisia, subjective awareness of restlessness and subjective distress related to restlessness are rated on a 4-point scale from 0 – 3 and are summed yielding a total score ranging from 0 (no akathisia) to 9 (severe akathisia).|Up to 13 days|Efficacy analysis population was defined as participants who received at least one dose of study drug.||Participants|||Number
767283|NCT00693485|Secondary|Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening.|Baseline, Month 6|Safety Population: all patients who received 1 dose of study medication or sham treatment||Number of Letters Read Correctly||Standard Deviation|Mean
767284|NCT00693485|Primary|Percentage of Patients With a Visual Field Improvement in the Study Eye|Visual field improvement in the study eye is determined using the Humphrey Field Analyzer (HFA 24-2) full threshold test and clinical expertise. The Humphrey Field Analyzer is a machine that helps to map the field (peripheral) of vision. An improvement is an increase in the field of vision. The percentage of patients with a visual field improvement in the study eye is reported.|Baseline, Month 6|Safety Population: all patients who received 1 dose of study medication or sham treatment||Percentage of Patients|||Number
767285|NCT00693498|Secondary|wrCRP Levels||days||||||
767286|NCT00693498|Primary|12 Hour Plasma Interleukin (IL)-6 to IL-10 Ratio|plasma was obtained pre-op, immediately once off cardiopulmonary bypass (CPB), six hours following CPB and 12 hours following CPB. The plasma was centrifuged and the supernatant collected and stored at -70 degrees. The samples then underwent Luminex testing for IL-6 and IL-10 levels, and the IL-6:IL-10 ratio was calculated (IL-6 being the numerator and IL-12 being the denominator). The 12 hour ratio was the primary outcome measure.|12 hours post-cardiopulmonary bypass|Only data from those subjects receiving transfusions was analyzed as the study intervention was the type of red blood cell and platelet transfusion (washed v. unwashed).||ratio||Standard Error|Median
767287|NCT00693628|Primary|Reduction in Time to Healing|time to healing in each group|1 year|study was closed due to low enrollment. Data were not collected.|||||
767288|NCT00693654|Secondary|VAS of Pruritus|Subject's self assessment of itching based on a 100 mm visual analog scale with 0 being no itching and 10 being most severe itching|Assessed at baseline and 4 weeks, week 4 reported|||units on a scale||Standard Deviation|Mean
767289|NCT00693654|Primary|Investigator Global Assessment|"Investigator’s Global Assessment Disease Severity is based on the following scale:
0 = completely clear: except for possible residual hyper pigmentation
= almost clear: very significant clearance (about 90%)
= Marked improvement: significant improvement (about 75%)
= Moderate improvement: intermediate between slight and marked; representing about 50% improvements
= Slight improvement: some improvement (about 25%); however, significant disease remaining
= No change (moderate to severe disease)
= Worse"|Disease severity assessed at baseline and 4 weeks, week 4 reported|||units on a scale||Standard Deviation|Mean
767290|NCT00693693|Primary|Adherence to Locoid|Adherence measured by MEMS cap as the % of days that the two total prescribed doses were applied|2 weeks|||percentage of days||Standard Deviation|Mean
767291|NCT00693706|Primary|Geometric Mean Fold-rise (GMFR) in 3 Strains of Influenza Disease.|GMFR was defined as the geometric mean of the ratio of the post-vaccination inverse HI titer to the Day 0 inverse HI titer. The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.)|At Day 0 and Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||fold rise||95% Confidence Interval|Geometric Mean
767292|NCT00693706|Primary|Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.)|At Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||subjects|||Number
767328|NCT00687973|Secondary|Change From Baseline of Aix Corrected to Heart Rate at Week 24|The heart rate correction was computed by a multivariate model analysis|Baseline and Week 24|Intent to treat (ITT) population; Last Observation Carried Forward (LOCF)||Ratio||Standard Error|Least Squares Mean
767293|NCT00693706|Primary|Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.|A seroprotected subject was defined as a vaccinated subject with a serum HI antibody titer ≥ 1:40, a level of HI antibody that has been viewed as correlating with protection against influenza. The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.)|At Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||subjects|||Number
767294|NCT00693706|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies for 3 Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.)|At Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||titers||95% Confidence Interval|Geometric Mean
767295|NCT00693706|Primary|Number of Subjects With Serious Adverse Events (SAEs).|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE = any SAE regardless of intensity or relationship to vaccination.|During the entire study period (Days 0-182)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||subjects|||Number
767296|NCT00693706|Primary|Number of Subjects With Unsolicited Adverse Events (AEs).|Unsolicited AEs cover any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any unsolicited AE = any unsolicited AE regardless of intensity or relationship to vaccination.|During the 90-day (Days 0-89) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||subjects|||Number
767297|NCT00693706|Primary|Number of Subjects With New Onset of Chronic Diseases (NOCDs).|NOCDs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.|During the entire study period (Days 0-182)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||subjects|||Number
767298|NCT00693706|Primary|Number of Subjects With Medically Attended Adverse Events (MAEs).|Medically-attended events (MAEs) refer to non-serious and serious events leading to an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits and hospitalization. Related MAE = MAE assessed by the investigator as related to the vaccination.|During the entire study period (Days 0-182)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||subjects|||Number
767299|NCT00693706|Primary|Number of Subjects With Solicited General Symptoms.|Solicited general symptoms were arthralgia, fatigue, headache, muscle aches, shivering and temperature, assessed as oral temperature above or equal (≥) 38.0 degrees Celsius (°C). Any = occurrence of a symptom regardless of intensity or relationship to vaccination.|During the 7-day (Days 0-6) post vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the documented dose. The analysis of solicited symptoms based on the Total Vaccinated cohort included only vaccinated subjects and doses with documented safety data (i.e., symptom screen /sheet completed).||subjects|||Number
767300|NCT00693706|Primary|Number of Subjects With Solicited Local Symptoms.|Solicited local symptoms were pain, redness and swelling at the injection site. Any = occurrence of a symptom regardless of intensity.|During the 7-day (Days 0-6) post vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the documented dose. The analysis of solicited symptoms based on the Total Vaccinated cohort included only vaccinated subjects and doses with documented safety data (i.e., symptom screen /sheet completed).||subjects|||Number
767301|NCT00693719|Secondary|Overall Survival|Still alive for a certain period of time after they were diagnosed with or started treatment|Measured from the start of protocol therapy until the date of death from any cause or will be censored at the date the patient was last known to be alive, assesed up to 13 months|||Days||95% Confidence Interval|Median
767302|NCT00693719|Primary|Median Time to Progression|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Measured time from the start of treatment to the time the patient is first recorded as having disease progression or dies. If no progression or death while being followed via tumor assessment, censored at last date known alive, assesed up to 13 months|||Days||Standard Error|Median
767303|NCT00693784|Secondary|Roland-Morris Disability Questionnaire|24-item questionnaire with score determined by the number of items checked by the subject. Items assess the effect of back pain on limitations of normal daily activities. Best value = 0 (least disability). Worst value = 24 (most disability). Higher number indicate greater disability.|Baseline, 26-weeks (primary endpoint), 52-weeks, 104-weeks|n=15 (all participants at baseline and 26-week primary endpoint) n=13 at 52 weeks n=11 at 104 weeks||Units on a scale||Standard Deviation|Mean
767304|NCT00693784|Secondary|Visual Analog Scale for Low-back Pain|"100 mm line anchored on the left with the descriptor No pain (best value = 0 mm) and anchored on the right with the descriptor Worst possible pain (worst value = 100 mm). Lower scores indicate less pain."|Baseline, 26-weeks (primary endpoint), 52-weeks, 104-weeks|n=15 (all participants at baseline and 26-week primary endpoint) n=13 at 52 weeks n=11 at 104 weeks||mm||Standard Deviation|Mean
767305|NCT00693784|Primary|Numbers and Types of Adverse Events (Only Number of Events is Reported in This Section - See Adverse Events Section for Further Detail)|The primary outcome for this safety study includes the number and types of adverse events reported in the study. The data fields in this section do not allow for reporting all aspects of this outcome (i.e., the number of adverse events, as well as the types of event). These numbers were entered and are reported in the adverse event section of the Results.|104 weeks|All 15 participants available through 26-week primary endpoint. One voluntary withdrawal and 1 lost-to-follow-up between 26-week follow-up and 52-week extended follow-up. One additional voluntary withdrawal and 1 additional lost-to-follow-up between 52-week extended follow-up and 104-week extended follow-up.||Events|||Number
767309|NCT00693992|Secondary|Percentage of Deterioration in QOL at 3 Months Using the EORTC QLQ-C30 Global Health Subscale|The percentage of patients with at least a 10% drop in the EORTC-QLQ-C30 Global Health Subscale score from baseline to 3-months. The difference between groups will be tested using Fisher's exact test.|At 3 months|Patients who completed the EORTC-QLQ-C30 Global Health Subscale at baseline and 3 months were included in this analysis.||percentage of patients|||Number
767310|NCT00693992|Secondary|Response Rate (RR)|"The percentage of patients who respond (completely or partially) to each combination regimen will be estimated. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria:
Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions."|Duration of treatment (up to 5 years)|||percentage of participants|||Number
767311|NCT00693992|Secondary|Overall Survival (OS)|Overall survival (OS) is defined as the time from patient randomization to death from any cause. The median OS with 95% CI was estimated using the Kaplan-Meier method.|Time from randomization to death (up to 5 years)|||months||95% Confidence Interval|Median
767312|NCT00693992|Primary|Progression Free Survival (PFS)|Progression Free Survival (PFS) was defined as the time from randomization until disease progression or death, whichever occurs first. The median PFS with 95% CI was estimated using the Kaplan-Meier method. Progression is defined as in the primary outcome measure.|Time from randomization to disease progression and death of any cause, whichever comes first (up to 5 years)|||months||95% Confidence Interval|Median
767313|NCT00694018|Primary|The Roland Morris Disability Questionnaire (RDQ) Score|The Roland Morris Disability Questionnaire score ranges from 0 to 24, with higher scores indicating greater disability|12 months|The number of participants analyzed is slightly lower than the number who completed the study at 12 months due to item non-response on the final study survey||units on a scale||Standard Deviation|Mean
767314|NCT00687830|Secondary|Patient Satisfaction in the Two Groups, All Morning Prep vs. All Evening Bowel Prep.|Variable used to assess patient satisfaction: Loss of sleep. The numbers below depict the number of participants who experienced loss of sleep.|An hour before the colonoscopy procedure|||participants|||Number
767315|NCT00687830|Primary|Comparing All Morning Bowel Prep to Evening Bowel Prep for Patients Undergoing Afternoon Colonoscopies. (Using Ottawa Scale Scores, Range 0-14) Lower Score Indicates a Better Outcome.||Within 1 hr after the colonoscopy procedure|||units on a scale||Standard Deviation|Mean
767316|NCT00687856|Secondary|Refine and Test Feedback Control Algorithm That Allows Precise Prescription of Cardiac Loading Through Synchronized and Asynchronized LVAD Operation With Native Left Ventricular Contraction||Measured at Year 3||||||
767317|NCT00687856|Primary|Number of Subjects With Left Ventricular Recovery and LVAD Explant|Noninvasive determination of left ventricular function using novel echocardiographic imaging methods and routine clinical assessments to optimize markers of left ventricular recovery. These markers would determine LVAD patients with cardiac recovery who no longer needed LVAD support.|Number of participants who had LV recovery and LVAD explant over 3 years.|The outcome measured were the number of patients who had cardiac recovery and who no longer required LVAD support and had successful LVAD explant. Of 211 LVAD recipients, there were 8 who had successful LVAD explant||Participants|||Count of Participants
767318|NCT00687908|Secondary|Percent of Subjects With Adverse Events|All participants with events were measured for that particular Outcome Measure and not only the events with a frequency threshold above 2 percent|Up to 24 weeks|||percent of subjects|||Number
767319|NCT00687908|Secondary|Investigator Global Assessment (IGA) Maintenance Success at Week 24|"IGA maintenance success is defined as the percentage of subjects with IGA grade inferior or equal to Baseline IGA grade.
IGA grade:
0 Clear:Residual hyperpigmentation & erythema may be present
Almost Clear:A few scattered comedones & a few small papules.
Mild:Some comedones & some papules and pustules. No nodules present
Moderate:Many comedones, papules & pustules. One nodule may be present
Severe:Covered with comedones, numerous papules & pustules & few nodules & cysts may be present
Very severe:Highly inflammatory acne covering the face; with nodules & cysts present"|Baseline, Week 24|ITT - Worst-case (Any missing data at each visit is considered as a failure, except where maintenance rate of both previous and following visits are success)||percent of subjects|||Number
767320|NCT00687908|Secondary|Maintenance Success for Non-inflammatory Lesions at Week 24|Maintenance success for non-inflamatory lesions at Week 24 is defined as the percentage of subjects maintaining at least 50 percent of the improvement obtained with prior combination therapy, in terms of non-inflamatory lesion counts.|Week 24|ITT - Worst-case (Any missing data at each visit is considered as a failure, except where maintenance rate of both previous and following visits are success)||percent of subjects|||Number
767321|NCT00687908|Secondary|Maintenance Success for Inflamatory Lesions at Week 24|Maintenance success for inflamatory lesions at Week 24 is defined as the percentage of subjects maintaining at least 50 percent of the improvement obtained with prior combination therapy, in terms of inflamatory lesion counts.|Week 24|ITT - Worst-case (Any missing data at each visit is considered as a failure, except where maintenance rate of both previous and following visits are success)||percent of subjects|||Number
767322|NCT00687908|Primary|Maintenance Success for Total Lesions at Week 24|Maintenance success for total lesions at Week 24 is defined as the percentage of subjects maintaining at least 50 percent of the improvement obtained with prior combination therapy, in terms of total lesion counts.|Week 24|ITT - Worst-case (Any missing data at Week 24 is considered as a failure)||percent of subjects|||Number
767323|NCT00687973|Secondary|Change From Baseline of Pulse Pressure at Week 24 (Office BP)||Baseline and Week 24|ITT Population||mmHg||Standard Deviation|Least Squares Mean
767324|NCT00687973|Secondary|Change From Baseline of SBP/DBP at Week 24 (Office BP)||Baseline and Week 24|ITT Population||mmHg||Standard Error|Least Squares Mean
767325|NCT00687973|Secondary|Change From Baseline of Brachial Pulse Pressure at Week 24 (Tonometry Center)||Baseline and Week 24|ITT Population||mmHg||Standard Error|Least Squares Mean
767326|NCT00687973|Secondary|Change From Baseline of Brachial SBP/DBP at Week 24 (Tonometry Center)|Applanation tonometry is a measurement of aortic pressure and vascular stiffness. To assess the central aortic blood pressure, it is necessary to calibrate the applanation tonometry device using the brachial blood pressure.|Baseline and Week 24|ITT population||mmHg||Standard Error|Least Squares Mean
767327|NCT00687973|Secondary|Change From Baseline of Pulse Wave Velocity at Week 24 (Radial Measurement)||Baseline and Week 24|Intent to treat (ITT) population; Last Observation Carried Forward (LOCF)||m/s||Standard Error|Least Squares Mean
767330|NCT00687973|Secondary|Change From Baseline of Augmentation Index (Aix) at Week 8|To calculate the blood pressure augmentation index, the inflection point of the pressure curve corresponding to the return of the reflection wave was determined. The ratio between the pressure located above and below the inflection point was calculated.|Baseline and Week 8|Intent to treat (ITT) population; Last Observation Carried Forward (LOCF)||Ratio||Standard Error|Least Squares Mean
767331|NCT00687973|Secondary|Change From Baseline of Central Pulse Pressure at Week 24 (Radial Measurement)||Baseline and Week 24|Intent to treat (ITT) population; Last Observation Carried Forward (LOCF)||mmHg||Standard Error|Least Squares Mean
767332|NCT00687973|Secondary|Change From Baseline of Central Systolic Blood Pressure (SBP) at Week 8 (Radial Measurement)||Baseline and Week 8|Intent to treat (ITT) population; Last Observation Carried Forward (LOCF)||mmHg||Standard Error|Least Squares Mean
767333|NCT00687973|Primary|Change From Baseline of Central Systolic Blood Pressure (SBP) at Week 24 (Radial Measurement)||Baseline and Week 24|Intent to treat (ITT) population; Last Observation Carried Forward (LOCF)||mmHg||Standard Error|Least Squares Mean
767334|NCT00688064|Secondary|Percent of Subjects With Adverse Events|Percent of subjects with Adverse Events all along the study (up to 12 weeks follow-up period)|Up to 12 weeks|ITT||% of subjects|||Number
767335|NCT00688064|Secondary|Success Rate on the Investigator's Global Assessment|"Percentage of subjects graded Clear or Almost Clear on 6-point IGA scale(0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe and 5=very severe)at week 12"|Week 12|ITT, LOCF||% of subjects|||Number
767336|NCT00688064|Secondary|Percent Change From Baseline in Non-inflammatory Lesion Counts at Week 12||Week 12|ITT, LOCF||% of change||Full Range|Median
767337|NCT00688064|Secondary|Percent Change From Baseline in Inflammatory Lesion Counts at Week 12.||Week 12|ITT, LOCF||% of change||Full Range|Median
767338|NCT00688064|Primary|Percent Change From Baseline in Total Lesion Counts at Week 12.||Week 12|ITT, LOCF||% of change||Full Range|Median
767339|NCT00688103|Primary|Radiographic Progression Defined by Change in Van Der Heijde-modified Total Sharp Score|"The van der Heijde-modifiedtotal Sharp score is the sum of scores for erosions and joint space narrowing. The minimum and maximum total scores are 0 and 448, respectively. The maximum number of erosions is 160 in the hands and 120 in the feet; and the maximum scores for joint space narrowing are 120 and 48, respectively.
Erosions are scored 1 for a discrete interruption of the cortical surface, and scored 2-5 for a larger defect according to the surface area of the joint involved. Notably, the maximum erosion score in each joint in hands is 5, while it is 10 in the feet.
For joint space narrowing, 0=normal; 1=focal or doubtful; 2=general, <50% of the original joint space; 3=general, >50% of the original joint space or subluxation; 4=ankylosis."|at 52 weeks|||units on a scale||Standard Deviation|Mean
767340|NCT00688103|Primary|ACR50 Response Rate|ACR (American College of Rheumatology) 50 response is defined by the following definition of improvement: at least 50% improvement in tender and swollen joint counts and at least 50% improvement in 3 of the 5 remaining ACR-core set measures; patient and physician global assessments, pain, disability, and an acute phase reactant (erythrocyte sedimentation rate or C-reactive protein).|at 24 weeks|||percentage of responders|||Number
767341|NCT00688103|Primary|EULAR Good Response|EULAR good response was defined as reaching, at least, low decease activity by the disease activity score of 28 joints (DAS28) and its improvement by > 1.2. DAS28 is a quantitative composite measure of disease activity for rheumatoid arthritis, and DAS28 < 3.2 is regarded as low disease activity.|at 24 weeks|||percentage of responders|||Number
767342|NCT00694070|Primary|Number of Participants That Could Answer at Least 85% of the Comprehension Questions Correctly (Comprehension of the Program Reports)|Subjects were asked thirty questions throughout the evaluation to test whether they understood the data displays, graphs and features of the software. Outcome measure was the number of participants that could answer at least 85% of the comprehension questions correctly.|1-2 hours|||participants|||Number
767343|NCT00694070|Primary|Number of Participants Rated as <= 3 (Success in Using the Program)|"Subjects were rated by study staff as to their success at performing basic tasks. The rating scale was:
successful
successful after being referred to user instructions
success with assistance (similar to a customer call)
unsuccessful 5 = software problem Outcome measure was the number of participants rated as <= 3."|1-2 hours|||Participants|||Number
767344|NCT00694070|Primary|Number of Participants That Rated 80% of Tasks as Very Simple, Simple, or Neither Simple Nor Difficult (Ease of Use of the Software Program)|"After completing each task, subjects rated the ease of performing each task on a scale of 1 to 5.
Very Simple
Simple
Neither simple nor difficult
Difficult
Very Difficult Outcome measure was the number of participants that rated 80% of tasks as 1,2, or 3."|1-2 hours|per protocol||Participants|||Number
767345|NCT00694096|Secondary|Overall Survival|The length of time from the start of treatment for a disease that patients are still alive; no time limit was imposed on data collection|2399 days|All patients that received study treatment and PET scans at baseline and follow-up||days||Full Range|Median
767346|NCT00694096|Primary|Proliferative Response|Number of patients achieving proliferative response (at least Partial Response) assessed with follow-up FLT-PET scans compared to baseline using the European Organization for Research and Treatment of Cancer (EORTC) response criteria based on the change in the follow-up average SUVmax relative to baseline as follows: Partial Response (PR) ≥ 25% decrease in SUVmax; Progressive Disease (PD) ≥ 25% increase in SUVmax; Stable Disease (SD) < 25% change in SUVmax.|4 weeks|Nineteen patients were included in the analysis. One patient was found to have pathologically proven sarcoidosis at the location of the PET imaging and was therefore removed from analysis.||participants|||Number
767347|NCT00694096|Primary|Metabolic Response|Number of patients achieving metabolic response (at least Partial Response) assessed with follow-up FDG-PET scans compared to baseline using the European Organization for Research and Treatment of Cancer (EORTC) response criteria based on the change in the follow-up average maximum standardized uptake value (SUVmax) relative to baseline as follows: Partial Response (PR) ≥ 25% decrease in SUVmax; Progressive Disease (PD) ≥ 25% increase in SUVmax; Stable Disease (SD) < 25% change in SUVmax.|4 weeks|Nineteen patients were included in the analysis. One patient was found to have pathologically proven sarcoidosis at the location of the PET imaging and was therefore removed from analysis.||participants|||Number
767723|NCT00697593|Primary|Urinalysis - Glucose|Urine samples were taken for clinical laboratory testing of the number of participants with or without glucose in urine|Week 12 / Early Termination|Safety Population - 3 participants with missing values||participants|||Number
767348|NCT00694109|Secondary|Percent Change From Baseline in Apolipoprotein A-1|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time.||percent change||95% Confidence Interval|Mean
767349|NCT00694109|Secondary|Change From Baseline in C-Reactive Protein|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time.||percent change||95% Confidence Interval|Mean
767350|NCT00694109|Secondary|Percent Change From Baseline in Total VLDL Particles' Size and Chylomicron Particles' Size|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for Total VLDL Particles' Size and Chylomicron Particles' Size.||percent change||95% Confidence Interval|Mean
767351|NCT00694109|Secondary|Percent Change From Baseline in VLDL Particles' Size (Small)|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for VLDL Particles' Size (Small).||percent change||95% Confidence Interval|Mean
767352|NCT00694109|Secondary|Percent Change From Baseline in VLDL Particles' Size (Medium)|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for VLDL Particles' Size (Medium).||percent change||95% Confidence Interval|Mean
767353|NCT00694109|Secondary|Percent Change From Baseline in Very Low Density Lipoprotein (VLDL) Particles' Size (Large) and Chylomicron Particles' Size|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for Very Low Density Lipoprotein (VLDL) Particles' Size (Large) and Chylomicron Particles' Size.||percent change||95% Confidence Interval|Mean
767354|NCT00694109|Secondary|Percent Change From Baseline in Intermediate Density Lipoprotein Particles' Size|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for Intermediate Density Lipoprotein Particles' Size.||percent change||95% Confidence Interval|Mean
767724|NCT00697593|Primary|Urinalysis - Ketones|Urine samples were taken for clinical laboratory testing of the number of participants with or without ketones in urine|Week 12 / Early Termination|||participants|||Number
767355|NCT00694109|Secondary|Percent Change From Baseline in HDL Particles' Size (Small)|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for HDL Particles' Size (Small).||percent change||95% Confidence Interval|Mean
767356|NCT00694109|Secondary|Percent Change From Baseline in HDL Particles' Size (Medium)|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for HDL Particles' Size (Medium).||percent change||95% Confidence Interval|Mean
767357|NCT00694109|Secondary|Percent Change From Baseline in HDL Particles' Size (Large)|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for LDL Particles' Size (Large).||percent change||95% Confidence Interval|Mean
767358|NCT00694109|Secondary|Percent Change From Baseline in LDL Particles' Size (Very Small)|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for LDL Particles' Size (Very Small).||percent change||95% Confidence Interval|Mean
767359|NCT00694109|Secondary|Percent Change From Baseline in LDL Particles' Size (Small)|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for LDL Particles' Size (Small).||percent change||95% Confidence Interval|Mean
767360|NCT00694109|Secondary|Percent Change From Baseline in LDL Particles' Size (Medium)|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for LDL Particles' Size (Medium).||percent change||95% Confidence Interval|Mean
767361|NCT00694109|Secondary|Percent Change From Baseline in LDL Particles' Size (Large)|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for LDL Particles' Size (Large).||percent change||95% Confidence Interval|Mean
767725|NCT00697593|Primary|Urinalysis - Protein|Urine samples were taken for clinical laboratory testing of the number of participants with or without protein in urine|Week 12 / Early Termination|||participants|||Number
767362|NCT00694109|Secondary|Percent Change From Baseline in LDL Particles' Size (Total)|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for LDL Particles' Size (Total).||percent change||95% Confidence Interval|Mean
767363|NCT00694109|Secondary|Percent Change From Baseline in Lipoprotein (a)|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time.||percent change||95% Confidence Interval|Mean
767364|NCT00694109|Secondary|Percent Change From Baseline in Triglycerides|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time.||percent change||95% Confidence Interval|Mean
767365|NCT00694109|Primary|Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non-HDL-C)|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time.||percent change||95% Confidence Interval|Mean
767366|NCT00694109|Primary|Percent Change From Baseline in Total Cholesterol|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time.||percent change||95% Confidence Interval|Mean
767367|NCT00694109|Primary|Percent Change From Baseline in Apolipoprotein B (Apo B)|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time.||percent change||95% Confidence Interval|Mean
767368|NCT00694109|Primary|Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C)|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time.||percent change||95% Confidence Interval|Mean
767369|NCT00694122|Primary|Blood Glucose|Average value of repeatedly measured absolute values beginning at 22:00, then hourly till 08:00. Participants were monitored during two overnight sampling periods. One overnight was while the participant was on NPH insulin as the long acting insulin; the other overnight was glargine(Lantus) insulin as the the long acting insulin.|Overnight|All participants received either NPH or glargine (Lantus) on separate overnight sampling periods.||mmol/l||Standard Deviation|Mean
767370|NCT00694122|Secondary|Growth Hormone|Mean growth hormone ug/l during NPH or glargine (Lantus) overnight visit. Hourly growth hormone was determined from 22:00 to 8:00.|Overnight|Participants completing both overnight visits were included in the analysis.||ug/l||Standard Deviation|Mean
767374|NCT00694122|Primary|Blood Glucose Area Under the Curve (AUC)|Cumulative sum of repeatedly measured blood glucose values (mg/dl) beginning at 22:00, then hourly till 08:00. Participants were monitored during two overnight sampling periods. One overnight was while the participant was on neutral protamine Hagedorn (NPH) insulin as the long acting insulin; the other overnight was glargine (Lantus) insulin as the the long acting insulin.|Overnight|All participants received either NPH or glargine (Lantus) on separate overnight sampling periods.||mg*10hr/dL||Standard Deviation|Mean
767375|NCT00694161|Other Pre-specified|Change From Baseline in 6-Minute Walk Test (6MWT) at Month 3, 6 and 12|6MWT was used to assess the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. Continuous pulse oximetry was conducted during the test for safety.. The distance walked in 6 minutes was categorized as: Level 1: <300 meter, Level 2: 300-374.9 meter, Level 3: 375-449.9 meter, Level 4: >=450 meter.|Baseline, Month 3, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here 'n' signifies those participants who were evaluable for specific timepoints.||meters||Standard Deviation|Mean
767376|NCT00694161|Other Pre-specified|Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide(NT-proBNP) Levels at Week 2, 6, Month 3, 6 and 12|NT-proBNP was a cardiac marker which had the prognostic value for participants with heart failure or left ventricular dysfunction. Higher level of the marker was indicative of heart damage.|Baseline, Week 2, Week 6, Month 3, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'n' signifies those participants who were evaluable for specific timepoints.||picogram/mL (pg/mL)||Standard Deviation|Mean
767377|NCT00694161|Other Pre-specified|Change From Baseline in Troponin I and Troponin T at Week 2, 6, Month 3, 6 and 12|Troponin I and troponin T were the cardiac markers. Troponin I and troponin T were part of the troponin complex, where troponin I was bound to actin in thin myofilaments and troponin T was bound to tropomyosin. Higher level of these markers was indicative of heart damage.|Baseline, Week 2, Week 6, Month 3, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'n' signifies those participants who were evaluable for specific timepoints.||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
767378|NCT00694161|Other Pre-specified|Change From Baseline in the Short Form 36 (SF-36) at Month 3, 6 and 12|SF-36 was standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. Scores for the 8 domains range from 0-100, where higher scores were better (100=highest level of functioning) and reported as 2 summary scores; Mental Component Score (MCS) and Physical Component Score (PCS). The score for a section was an average of the individual question scores, which were scaled 0-100, where higher scores were better.|Baseline, Month 3, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'n' signifies those participants who were evaluable for specific timepoints. Data was collected at Month 3 but not statistically summarized as planned.||Units on a scale||Standard Deviation|Mean
767379|NCT00694161|Other Pre-specified|Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Score at Month 3, 6 and 12|KCCQ was a 23-item heart failure specific questionnaire quantified in to following 10 summary scores: physical limitation, symptom frequency, symptom severity, and symptom stability, total symptoms, quality of life, social interference, self-efficacy, overall summary and clinical summary. Total score ranged from 0 to 100, where higher scores indicated better functioning, fewer symptoms, and better disease specific quality of life. Summary scores were scaled to range from 0 to 100, with higher scores representing greater disability.|Baseline, Month 3, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'n' signifies those participants who were evaluable for specific timepoints.||Units on a scale||Standard Deviation|Mean
767380|NCT00694161|Other Pre-specified|Number of Participants With Change in Patient Global Assessment (PtGA) at Month 3, 6 and 12|"Participant’s overall quality of life was measured by the PtGA. At baseline participants answered to question: in general, how do you feel today? - on a 5-point scale from '1' (excellent) to '5' (poor). At each follow-up visit, participant’s answered to question: “How do you feel today as compared to when we talked with you at your last clinic visit for this study?” on a 7-point scale- '1' markedly improved, '2' moderately improved, '3' mildly improved, '4' unchanged, '5' mildly worsened, '6' moderately worsened, '7' markedly worsened."|Baseline, Month 3, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here 'n' signifies those participants who were evaluable for specific timepoints.||Participants|||Number
767381|NCT00694161|Other Pre-specified|Number of Participants With Increased Interstitial Markings and Pleural Effusions|Chest x-ray was done to record the presence of increased interstitial markings (a large number of interstitial markings was indicative of abnormality in the lung) and pleural effusion, which was defined as accumulation of fluid between the layers of tissue that line the lungs and chest cavity.|Baseline, Month 6, Month 12|Intent to Treat (ITT) population included all participants who received at least one dose of study medication.||Participants|||Number
767382|NCT00694161|Other Pre-specified|Cardiothoracic (CT) Ratio|Cardiothoracic ratio was defined as the transverse diameter of the heart, compared with that of the thoracic cage, used to help determine enlargement of the heart.|Baseline, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication.||Ratio||Standard Deviation|Mean
767383|NCT00694161|Other Pre-specified|Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Week 6, Month 3, 6 and 12|NYHA: classified as ‘class I’ (participants with cardiac disease but without resulting limitations of physical activity), ‘class II’ (participants with cardiac disease resulting in slight limitation of physical activity), ‘class III’ (participants with cardiac disease resulting in marked limitation of physical activity), ‘class IV’ (participants with cardiac disease resulting in inability to carry on any physical activity without discomfort). Participants with change from baseline were classified as ‘improved' (positive change), ‘no change’ or ‘worsened' (negative change).|Baseline, Week 6, Month 3, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Data at Week 6 was collected but was not summarized due to a change in the planned analysis. Here 'n' signifies those participants who were evaluable for specific timepoints.||Participants|||Number
767384|NCT00694161|Other Pre-specified|Heart Rate Variability- Percentage of Successive R-R Intervals With Greater Than 50 Msec Difference Between Normal Beats (pNN50)|Holter monitor was a machine that recorded the heart rhythms. The term ‘NN’ was used in place of ‘R-R’ when the processed beats are normal beats. The percentage of successive R-R intervals with greater than 50 msec difference between normal beats was derived by dividing NN50 by the total number of NN intervals (pNN50), where NN50 was the number of interval differences of successive NN intervals greater than 50 msec.|Baseline, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here 'n' signifies those participants who were evaluable for specific timepoints.||Percentage of intervals||Standard Deviation|Mean
767385|NCT00694161|Other Pre-specified|Heart Rate Variability (HRV)- Standard Deviation (SD) Parameters|Holter monitor was a machine that recorded the heart rhythms. HRV time-domain indices were summarized for root-mean-square of successive differences [RMS SD] of the R-R intervals (R-R is the interval between successive Rs in the ECG wave) between normal beats (NN), magid standard deviation (Magid SD) of normal to normal R-R intervals and Kleiger standard deviation of normal to normal R-R intervals (Kleiger SD). The term ‘NN’ is used in place of ‘R-R’ when the processed beats are normal beats.|Baseline, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here 'n' signifies those participants who were evaluable for specific timepoints.||msec||Standard Deviation|Mean
767386|NCT00694161|Other Pre-specified|Number of Participants With Complete Heart Block|Complete heart block is the third-degree atrioventricular block in which the impulse generated in the sinoatrial node in the atrium does not propagate to the ventricles.|Baseline, Month 6, Month 12|No summary was prepared for this data as there were no reports of complete heart block.|||||
767387|NCT00694161|Other Pre-specified|24-Hour Average Heart Rate and Maximium/Minimum Heart Rate|Holter monitor was a machine that recorded the heart rhythms. 24-hour average heart rate and maximium/minimum heart rate was recorded using Holter monitoring.|Baseline, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here 'n' signifies those participants who were evaluable for specific timepoints.||beats per minute (bpm)||Standard Deviation|Mean
767388|NCT00694161|Other Pre-specified|Number of Participants With Atrial Fibrillation/Flutter, Atrial Tachycardia, Non-Sustained Ventricular Tachycardia (NSVT) Beats), Sustained Ventricular Tachycardia (SVT), Sinus Pause at Month 6 and 12|Holter monitor was a machine that recorded the heart rhythms. Holter monitoring abnormalities of atrial fibrillation/flutter (rapid, irregular heart rhythm), atrial tachycardia (rapid cardiac rate), non-sustained ventricular tachycardia (NSVT)<30 beats, sustained ventricular tachycardia (SVT) >=30 beats and sinus pause (transient interruption in the sinus rhythm) were recorded.|Baseline, Month 6, Month 12|ITT population. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. The ‘n’ for any post-dose incidence included participants with baseline values that were not abnormal(that is treatment-emergent abnormalities).||Participants|||Number
767389|NCT00694161|Other Pre-specified|Change From Baseline in 4 Chamber Left Atrial Dimension and 4 Chamber Right Atrial Dimension at Month 6 and 12|Cardiac MRI was done to measure the left and right atrial dimensions which have diagnostic and prognostic significance in cardiology, in the 4 chamber view.|Baseline, Month 6, Month 12|Data for this measure was not collected due to a change in the planned analysis.|||||
767390|NCT00694161|Other Pre-specified|Change From Baseline in 4 Chamber Interatrial Septal Thickness at Month 6 and 12|Cardiac MRI was done to measure interatrial septal thickness in the 4 chamber view.|Baseline, Month 6, Month 12|Data for this measure was not collected due to a change in the planned analysis.|||||
767391|NCT00694161|Other Pre-specified|Change From Baseline in Percentage of Left Ventricular Myocardial Mass With Amyloidosis and Left Ventricular Myocardial Mass With Fibrosis/Scar at Month 6 and 12|Cardiac MRI was done to measure percentage of LV myocardial mass with amyloidosis and LV myocardial mass with fibrosis/scar. LV myocardial mass with amyloidosis or fibrosis/scar was calculated from the product of the myocardial volume and specific gravity of heart muscle, in participants with amyloidosis or fibrosis/scar, respectively.|Baseline, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here 'n' signifies those participants who were evaluable for specific timepoints.||Percentage of LVM||Standard Deviation|Mean
767392|NCT00694161|Other Pre-specified|Change From Baseline in Left Ventricular Cardiac Output and Right Ventricular Cardiac Output at Month 6 and 12|Cardiac MRI was done to measure cardiac output, which was the volume of blood being pumped by the heart, in particular by the left or right ventricle in the time interval of one minute.|Baseline, Month 6, Month 12|MRI data was collected and reported for cardiac output through the measure of stroke volume as given in outcome measure 17.|||||
767393|NCT00694161|Other Pre-specified|Change From Baseline in Left Ventricular Ejection Fraction and Right Ventricular Ejection Fraction at Month 6 and 12|Cardiac MRI was done to measure: left ventricular ejection fraction (LVEF) was the fraction of the EDV that is ejected out of left ventricle with each contraction and right ventricular ejection fraction (RVEF) was the fraction of the EDV that is ejected out of right ventricle with each contraction. EDV is the volume of blood within a ventricle immediately before a contraction.|Baseline, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here 'n' signifies those participants who were evaluable for specific timepoints.||Percentage of EDV||Standard Deviation|Mean
767404|NCT00694161|Other Pre-specified|Change From Baseline in Echocardiographic (ECHO) Parameters at Month 6 and 12|Echocardiography was used to measure interventricular septal thickness (IVST), posterior left ventricular wall thickness (PLVWT), right ventricular wall thickness (RVWT), left atrial diameter (LAD): anterior-posterior (ant-post), medio-lateral, superior-inferior (sup-inf) and left ventricular end diastolic diameter (LVEDD).|Baseline, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here 'n' signifies those participants who were evaluable for specific timepoints.||millimeter (mm)||Standard Deviation|Mean
767394|NCT00694161|Other Pre-specified|Change From Baseline in Left Ventricle End Diastolic Volume, Left Ventricle End Systolic Volume, Left Ventricle Stroke Volume, Right Ventricle End Diastolic Volume, Right Ventricle End Systolic Volume, Right Ventricle Stroke Volume at Month 6 and 12.|Cardiac MRI was done to measure left ventricle end diastolic volume (LVEDV), left ventricle end systolic volume (LVESV), left ventricle stroke volume (LVSV), right ventricle end diastolic volume (RVEDV), right ventricle end systolic volume (RVESV) and right ventricle stroke volume (RVSV).|Baseline, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here 'n' signifies those participants who were evaluable for specific timepoints.||mL||Standard Deviation|Mean
767395|NCT00694161|Other Pre-specified|Change From Baseline in Left Ventricular Mass, Mass of Left Ventricular Myocardium With Amyloidosis, Mass of Left Ventricular Myocardium With Fibrosis/Scar and Right Ventricular End Diastolic Mass at Month 6 and 12|Cardiac MRI was done to measure LVM, mass of left ventricular (LV) myocardium with amyloidosis, mass of LV myocardium with fibrosis/scar and right ventricular end diastolic mass (RVEDM).|Baseline, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here 'n' signifies those participants who were evaluable for specific timepoints.||Gram||Standard Deviation|Mean
767396|NCT00694161|Other Pre-specified|Change From Baseline in Left Ventricular Anteroseptal, Left Ventricular Inferolateral Wall Thickness and Right Ventricular End Diastolic Free Wall Thickness at Month 6 and 12|Cardiac Magnetic Resonance Imaging (MRI) was done to measure the thickness of left ventricular anteroseptal (LVAS) wall, left ventricular inferolateral (LVIL) wall and right ventricular end diastolic free (RVEDF) wall.|Baseline, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here 'n' signifies those participants who were evaluable for specific timepoints.||mm||Standard Deviation|Mean
767397|NCT00694161|Other Pre-specified|Number of Participants With Change From Baseline in Valvular Abnormalities at Month 6 and 12|Valvular abnormalities were those abnormalities (thickening or regurgitation) that involved one or more valves of the heart, determined by echocardiography.|Baseline, Month 6, Month 12|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis.|||||
767398|NCT00694161|Other Pre-specified|Change From Baseline in Pericardial Effusion at Month 6 and 12|Pericardial effusion was the presence of an abnormal amount of fluid in the pericardial cavity, as determined by echocardiography.|Baseline, Month 6, Month 12|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis.|||||
767399|NCT00694161|Other Pre-specified|Change From Baseline in Tissue Doppler- Septal and Lateral Velocity at Month 6 and 12|Tissue Doppler used doppler principles to measure the annular velocities at the lateral and septal areas of the mitral annulus. s’: systolic velocity during ejection, e’: early diastolic mitral annular velocity, a’: late diastolic mitral annular velocity.|Baseline, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here 'n' signifies those participants who were evaluable for specific categories.||centimeter/second (cm/sec)||Standard Deviation|Mean
767400|NCT00694161|Other Pre-specified|Change From Baseline in Doppler Data: Mitral Deceleration Time at Month 6 and 12|Doppler echocardiography was a procedure which used ultrasound technology to examine the heart. The mitral deceleration time was the time taken from the maximum E wave to baseline. E wave arises due to early diastolic filling.|Baseline, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here 'n' signifies those participants who were evaluable for specific timepoints.||msec||Standard Deviation|Mean
767401|NCT00694161|Other Pre-specified|Change From Baseline in Doppler Data: E/A and E/e' Ratio at Month 6 and 12|Doppler echocardiography was a procedure which used ultrasound technology to examine the heart. Ratio of early (E) diastolic transmitral flow velocity and atrial (A) contraction velocity (E/A) and ratio of the early (E) diastolic transmitral flow velocity to the mitral annular velocity (e’) (E/e') were estimated.|Baseline, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here 'n' signifies those participants who were evaluable for specific timepoints.||Ratio||Standard Deviation|Mean
767402|NCT00694161|Other Pre-specified|Change From Baseline in Left Ventricular Ejection Fraction at Month 6 and 12|Left ventricular ejection fraction (LVEF) was the fraction of the end-diastolic volume (EDV) that is ejected out of left ventricle with each contraction, estimated by echocardiography. EDV is the volume of blood within a ventricle immediately before a contraction.|Baseline, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here 'n' signifies those participants who were evaluable for specific timepoints.||Percentage of EDV||Standard Deviation|Mean
767403|NCT00694161|Other Pre-specified|Change From Baseline in Left Ventricular Mass (LVM) at Month 6 and 12|LVM was defined as increase in the mass of left ventricle, estimated by echocardiography. Increased LVM was associated with cardiovascular morbidity and mortality.|Baseline, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here 'n' signifies those participants who were evaluable for specific timepoints.||Gram||Standard Deviation|Mean
767405|NCT00694161|Other Pre-specified|Number of Participants Discontinuing From The Study Due to Clinically Significant Clinical or Laboratory Adverse Events (AEs)||Baseline up to Month 12|ITT population included all participants who received at least one dose of study medication.||Participants|||Number
767448|NCT00696020|Secondary|Tmax,ss Olodaterol [h]|"Time from last dosing to maximum concentration of Olodaterol in plasma at steady state (tmax,ss) after 4 weeks treatment.
No results displayed for Tiotropium+Olodaterol 5/2 μg because there were zero total participants analyzed for this outcome measure."|Pre-dose, 5 min, 10 min, 20 min, 40 min, 1 h, 3 h, and 6 h after the last dose.|Evaluable patients.||hours||Full Range|Median
767406|NCT00694161|Other Pre-specified|Number of Participants With Clinically Significant Treatment-Emergent Echocardiography (ECHO) Findings|ECHO:investigator assessed test to assess cardiac function.ECHO abnormality criteria:any/valvular abnormality,pericardial effusion,abnormal regional wall motion,inferior vena cava respiratory variation,posterior left ventricular wall/septal thickness>=13 millimeter(mm),right ventricular thickness>=7mm,ejection fraction <50%, ratio of early (E) diastolic transmitral flow and atrial(A) contraction velocity (E/A)>=2, ratio of ‘E’to lateral/septal mitral annular velocity (e’) (E/e’prime lateral>15, E/e’prime septal>15), E deceleration time<=150 millisecond(msec),Isovolumic relaxation time<=70msec.|Baseline up to Month 12|ITT population. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. The ‘n’ for any post-dose incidence included participants with baseline values that were not abnormal(that is treatment-emergent abnormalities).||Participants|||Number
767407|NCT00694161|Other Pre-specified|Number of Participants With Greater Than or Equal to (>=) Grade 3 Treatment-Emergent AEs|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. On the basis of intensity, grade 3 was referred as severe, grade 4 as life-threatening and grade 5 as death.|Baseline up to 30 days after the last dose|ITT population included all participants who received at least one dose of study medication.||Participants|||Number
767408|NCT00694161|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to 30 days after the last dose|ITT population included all participants who received at least one dose of study medication.||Participants|||Number
767409|NCT00694161|Secondary|Percentage of Participants With Stabilized Transthyretin (TTR Tetramer) at Month 6 and 12|TTR tetramer was assessed using a validated immunoturbidimetric assay. The Fraction of Initial (FOI) is the ratio of the measured TTR tetramer concentration after denaturation to the measured TTR tetramer concentration before denaturation. TTR tetramer stabilization is based on the difference between the on-treatment FOI and the baseline FOI expressed as a percentage of the baseline FOI.|Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||Percentage of participants||95% Confidence Interval|Number
767410|NCT00694161|Primary|Percentage of Participants With Stabilized Transthyretin (TTR Tetramer) at Week 6|TTR tetramer was assessed using a validated immunoturbidimetric assay. The Fraction of Initial (FOI) is the ratio of the measured TTR tetramer concentration after denaturation to the measured TTR tetramer concentration before denaturation. TTR tetramer stabilization is based on the difference between the on-treatment FOI and the baseline FOI expressed as a percentage of the baseline FOI.|Week 6|Intent-to-Treat (ITT) population included all participants who received at least one dose of study medication.||Percentage of participants||95% Confidence Interval|Number
767411|NCT00694304|Secondary|Change From Baseline in SDS Total Score After 52 Weeks of Treatment|The Sheehan Disability Scale (SDS) comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). The higher the score, the more severe.|Baseline and Week 52|FAS; OC||units on a scale||Standard Deviation|Mean
767412|NCT00694304|Secondary|Proportion of Patients With a MADRS Total Score >=22 After 52 Weeks of Treatment||Baseline and Week 52|FAS; OC||percentage of patients|||Number
767413|NCT00694304|Secondary|Proportion of Remitters at Week 52 (Remission Defined as a MADRS Total Score <=10)||Week 52|FAS; OC; Baseline from lead-in study NCT00635219 / 11984A||percentage of patients||Standard Deviation|Mean
767414|NCT00694304|Secondary|Proportion of Responders at Week 52 (Response Defined as a >=50% Decrease in MADRS Total Score)||Week 52|FAS; OC; Baseline from lead-in study NCT00635219 / 11984A||percentage of patients||Standard Deviation|Mean
767415|NCT00694304|Secondary|Change From Baseline in CGI-S Score After 52 Weeks of Treatment|The Clinical Global Impression - Severity of Illness (CGI-S) is a 7-point scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The investigator should use his/her total clinical experience with this patient population to judge how mentally ill the patient is at the time of rating.|Baseline and Week 52|FAS; OC||units on a scale||Standard Deviation|Mean
767416|NCT00694304|Secondary|Change From Baseline in HAM-A Total Score After 52 Weeks of Treatment|The Hamilton Anxiety Rating Scale (HAM-A) consists of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behaviour at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic, and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total score from 0 to 56. The higher the score, the more severe.|Baseline and Week 52|FAS; OC||units on a scale||Standard Deviation|Mean
767417|NCT00694304|Secondary|Change From Baseline in HAM-D-24 Total Score After 52 Weeks of Treatment|The Hamilton Depression Scale - 24 Items (HAM-D-24) measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 76. The higher the score, the more severe.|Baseline and Week 52|FAS; OC||units on a scale||Standard Deviation|Mean
767418|NCT00694304|Secondary|Change From Baseline in MADRS Total Score After 52 Weeks of Treatment|The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe.|Baseline and Week 52|FAS; observed cases (OC)||units on a scale||Standard Deviation|Mean
767419|NCT00694304|Primary|Percentage of Patients Who Withdrew Due to Intolerance to Treatment||Baseline to Week 52|APTS||percentage of patients|||Number
767421|NCT00694356|Secondary|Number of Participants Who Developed a Human Anti-Humanized Antibody (HAHA) Response to Dalotuzumab|Formation of HAHAs may block efficacy by substantially increasing the clearance of dalotuzumab and limit the possibility of future dalotuzumab therapy. The occurrence of HAHAs in the sera of dalotuzumab treated participants at any of the serum collection times was assessed.|Cycle 1: predose on Days 1, 8, 15, and 22; Cycles 2 and 3: predose on Day 1; 4 weeks after last dose of study drug|The population consisted of all participants who received at least one dose of study treatment.||Participants|||Number
767422|NCT00694356|Secondary|Steady State Volume of Distribution (Vss) of Dalotuzumab|Vss was assessed on Week 2 (Day 8) for the Dalotuzumab 5 mg/kg and Dalotuzumab 10 mg/kg treatment groups and on Week 3 (Day 15) for the Dalotuzumab 15 mg/kg/7.5 mg/kg treatment group.|Pre-dose, 0.5 h after start of infusion, end of infusion, 5, 10, 24, 30, 48 and 96 and 168 h post-dose|The population consisted of all participants who had PK measurements at Baseline and at least once during treatment.||L/kg||Geometric Coefficient of Variation|Geometric Mean
767423|NCT00694356|Secondary|Clearance (CL) of Dalotuzumab|CL of dalotuzumab was assessed on Week 2 (Day 8) for the Dalotuzumab 5 mg/kg and Dalotuzumab 10 mg/kg treatment groups and on Week 3 (Day 15) for the Dalotuzumab 15 mg/kg/7.5 mg/kg treatment group.|Pre-dose, 0.5 h after start of infusion, end of infusion, 5, 10, 24, 30, 48 and 96 and 168 h post-dose|The population consisted of all participants who had PK measurements at Baseline and at least once during treatment.||mL/min/kg||Geometric Coefficient of Variation|Geometric Mean
767424|NCT00694356|Secondary|Apparent Terminal Half-life (t1/2) of Dalotuzumab|t1/2 was assessed on Week 2 (Day 8) for the Dalotuzumab 5 mg/kg and Dalotuzumab 10 mg/kg treatment groups and on Week 3 (Day 15) for the Dalotuzumab 15 mg/kg/7.5 mg/kg treatment group.|Pre-dose, 0.5 h after start of infusion, end of infusion, 5, 10, 24, 30, 48 and 96 and 168 h post-dose|The population consisted of all participants who had PK measurements at Baseline and at least once during treatment.||h||Geometric Coefficient of Variation|Geometric Mean
767425|NCT00694356|Secondary|Time to Cmax (Tmax) of Dalotuzumab|Tmax was assessed on Week 2 (Day 8) for the Dalotuzumab 5 mg/kg and Dalotuzumab 10 mg/kg treatment groups and on Week 3 (Day 15) for the Dalotuzumab 15 mg/kg/7.5 mg/kg treatment group.|Pre-dose, 0.5 h after start of infusion, end of infusion, 5, 10, 24, 30, 48 and 96 and 168 h post-dose|The population consisted of all participants who had PK measurements at Baseline and at least once during treatment.||h||Full Range|Median
767426|NCT00694356|Secondary|Area Under the Concentration-Time Curve From Zero to Infinity (AUC0-∞) of Dalotuzumab|AUC0-∞ was assessed on Week 2 (Day 8) for the Dalotuzumab 5 mg/kg and Dalotuzumab 10 mg/kg treatment groups and on Week 3 (Day 15) for the Dalotuzumab 15 mg/kg/7.5 mg/kg treatment group.|Pre-dose, 0.5 h after start of infusion, end of infusion, 5, 10, 24, 30, 48 and 96 and 168 h post-dose|The population consisted of all participants who had PK measurements at Baseline and at least once during treatment.||mg*h/mL||Geometric Coefficient of Variation|Geometric Mean
767427|NCT00694356|Secondary|Maximum Plasma Concentration (Cmax) of Dalotuzumab|Cmax was assessed on Week 2 (Day 8) for the Dalotuzumab 5 mg/kg and Dalotuzumab 10 mg/kg treatment groups and on Week 3 (Day 15) for the Dalotuzumab 15 mg/kg/7.5 mg/kg treatment group.|Pre-dose, 0.5 h after start of infusion, end of infusion, 5, 10, 24, 30, 48 and 96 and 168 h post-dose|The population consisted of all participants who had pharmacokinetic (PK) measurements at Baseline and at least once during treatment.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
767428|NCT00694356|Primary|Number of Participants Who Discontinued Study Treatment Due to an AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of study treatment. Any worsening (i.e. any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which was temporally associated with the use of study treatment, was also an AE. The number of participants who discontinued study treatment due to an AE is presented.|Up to 71 days|The population consisted of all participants who received at least one dose of study treatment.||Participants|||Number
767429|NCT00694356|Primary|Number of Participants Who Experienced an Adverse Event (AE)|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of study treatment. Any worsening (i.e. any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which was temporally associated with the use of study treatment, was also an AE. The number of participants who experienced at least one AE is presented.|Up to 30 days after last dose of study treatment (Up to 101 days)|The population consisted of all participants who received at least one dose of study treatment.||Participants|||Number
767430|NCT00694356|Primary|Number of Participants Who Experienced a Dose-limiting Toxicity (DLT)|Toxicity was graded and recorded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. DLTs were defined as the occurrence of any of the following events when judged to be related to the study medication: Grade 4 neutropenia; Grade 3 neutropenia with fever >38.5°C; Grade 4 thrombocytopenia; Grade 3 or Grade 4 non-hematologic toxicity, except alopecia and inadequately treated diarrhea, nausea and vomiting. The number of participants who experienced a DLT is presented.|Cycle 1 (Up to 4 weeks)|The population consisted of all participants who received at least one dose of study treatment.||Participants|||Number
767431|NCT00694369|Secondary|Patient’s Global Assessment of Study Medication at 24 Hours Post the Initial Day 1 Dose of the Study Medication|Patient’s Global Assessment of Study Medication was on 0- to 4- point scale, with 0=Poor, and 4=Excellent for patient’s rating of the study medication for pain.|At 24 hours post the initial Day 1 dose of the study medication|Full Analysis Set population (all randomized patients who received at least 1 dose of study treatment and had at least 1 post-baseline assessment at 24 hours). Observed data was used. Forty patients were excluded from the analysis due to no measurement at 24 hours after the initial Day 1 dose.||Participants|||Number
767447|NCT00696020|Secondary|AUC(0-1h,ss) Olodaterol [pg*h/mL]|"Area under the concentration-time curve of Olodaterol in plasma at steady state (AUC(0-1h,ss)) from 0 to 1 hour post dosing after 4 weeks of treatment.
No results displayed for Tiotropium+Olodaterol 5/2 μg because there were zero total participants analyzed for this outcome measure."|Pre-dose, 5 min, 10 min, 20 min, 40 min, 1 h, 3 h, and 6 h after the last dose.|Evaluable patients.||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
767726|NCT00697593|Primary|Urinalysis - pH|Urine samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 3 participants missing values||pH units||Standard Deviation|Mean
767432|NCT00694369|Primary|Total Pain Relief Score Over the First 6 Hours Post the Initial Day 1 Dose of the Study Medication (TOPAR6)|TOPAR6 was calculated by multiplying the pain relief (PR) score (0- to 4-point Likert scale, with 0=None, and 4=Complete for pain relief) at each time point by the duration (in hours) since the preceding time point, and summing these weighted values up to 6 hours post the initial Day 1 dose. The range of TOPAR6 score is 0 to 24.|Over the first 6 hours post the initial Day 1 dose of the study medication|Full Analysis Set population (all randomized patients who received at least 1 dose of study treatment and had at least 1 post-baseline PR data over the first 6 hours). Observed PR was used up to rescue. Missing data was imputed by linear interpolation at time points before rescue, by last-observation-carried-forward at time points after rescue.||Units on a Scale||Standard Error|Least Squares Mean
767433|NCT00695864|Primary|Change in Withdrawal Symptoms With Placebo and With Ondansetron|Subjective Opioid Withdrawal Scale: Participants were asked to rate, from 0 to 4, their experience of 15 withdrawal symptoms. Scores for each participant were derived from the sum of their withdrawal symptoms score (minimum:0, maximum: 60). A higher score indicates more symptoms experienced and/or at a greater degree of severity.|Baseline, 1 hour post dose Placebo, 1 hour post dose Ondansetron|9 participants and 13 independent trials (3 patients had more than 1 distinct withdrawal episode) were analyzed. Of the 14 participants assigned to intervention, 5 were withdrawn from the study and/or analysis.||Percent change||Standard Error|Mean
767434|NCT00695903|Secondary|Number of Participants With Treatment Cure at Test of Cure (TOC)/Safety Visit|Investigator's assessment of clinical response. Treatment Cure includes successful outcomes of both clinical and microbiological assessments. Clinical cure is defined by clinical improvement of symptoms and signs associated with the underlying infection such that no further anti-infective therapy is required. Microbiological Success is defined by the eradication or presumed eradication of baseline infecting methicillin-resistant S. aureus pathogen and no superinfecting pathogen(s) (Gram-positive) or metastatic methicillin-resistant S. aureus pathogens were isolated post therapy.|Test of Cure (TOC) Visit (35 to 49 days post-therapy, approximately week 8)|Subset of modified intent-to-treat population who completed TOC/Safety visit||participants|||Number
767435|NCT00695903|Primary|Number of Participants With Elevated Serum Creatinine|Number of participants with treatment-emergent serum creatinine increases ≥0.5 mg/dL (for patients with a baseline value ≤3.0 mg/dL) or ≥1.0 mg/dL (for patients with a baseline value >3.0 mg/dL) by the EOT visit.|On therapy and up to 3 days post-therapy (treatment duration ranged from 2 to 43 days)|All subjects who received at least one dose of study medication (Safety Population). Two patients in the high-dose vancomycin arm were randomized but not treated and therefore not included in the safety population.||participants|||Number
767436|NCT00695903|Secondary|Number of Participants With Treatment Cure at End of Therapy (EOT) Visit|Investigator's assessment of treatment cure. Treatment Cure includes successful outcomes of both clinical and microbiological assessments. Clinical cure is defined by clinical improvement of symptoms and signs associated with the underlying infection such that no further anti-infective therapy is required. Microbiological Success is defined by the eradication or presumed eradication of baseline infecting methicillin-resistant S. aureus pathogen and no superinfecting pathogen(s) (Gram-positive) or metastatic methicillin-resistant S. aureus pathogens were isolated post therapy.|End of Therapy (median day 12 and 6.5 in daptomycin and vancomycin modified intent-to treat population, respectively)|Patients who met the continuation criteria (modified intent-to-treat) and had a EOT assessment of clinical outcome.||participants|||Number
767437|NCT00695903|Primary|Number of Participants With Treatment-emergent Creatine Phosphokinase (CPK) Elevations|Number of participants with treatment-emergent CPK elevations ≥5 x upper limit of normal (≥1,000 U/L) by the EOT visit.|On therapy and up to 3 days post-therapy (treatment duration ranged from 2 to 43 days)|All subjects who received at least one dose of study medication (Safety Population). Two patients in the high-dose vancomycin arm were randomized but not treated and therefore not included in the safety population.||Participants|||Number
767438|NCT00695955|Secondary|Change From Baseline in Sitting Clinic Diastolic Blood Pressure - Cohort 2.|The change between sitting clinic diastolic blood pressure measured at each week assessed relative to the baseline measurement. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.|52 weeks.|Full Analysis Set.||mmHg||Standard Deviation|Mean
767439|NCT00695955|Secondary|Change From Baseline in Sitting Clinic Diastolic Blood Pressure - Cohort 1.|The change between sitting clinic diastolic blood pressure measured at each week assessed relative to the baseline measurement. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.|52 weeks.|Full Analysis Set.||mmHg||Standard Deviation|Mean
767440|NCT00695955|Secondary|Change From Baseline in Sitting Clinic Systolic Blood Pressure - Cohort 2|The change between sitting clinic systolic blood pressure measured at each week assessed relative to the baseline measurement. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.|52 weeks|Full Analysis Set.||mmHg||Standard Deviation|Mean
767441|NCT00695955|Secondary|Change From Baseline in Sitting Clinic Systolic Blood Pressure - Cohort 1.|The change between sitting clinic systolic blood pressure measured at each week assessed relative to the baseline measurement. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.|52 weeks|Full Analysis Set.||mmHg||Standard Deviation|Mean
767442|NCT00695955|Primary|Number of Participants Reporting One or More Treatment-emergent Adverse Events From Day 1 Through End of the Study - Cohort 2.|Treatment-emergent adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after the last dose of study drug, or if a serious adverse event, within 30 days after the last dose of study drug.|56 weeks.|Full Analysis Set.||participants|||Number
767443|NCT00695955|Primary|Number of Participants Reporting One or More Treatment-emergent Adverse Events From Day 1 Through End of the Study - Cohort 1.|Treatment-emergent adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after the last dose of study drug, or if a serious adverse event, within 30 days after the last dose of study drug.|56 weeks.|Full Analysis Set.||participants|||Number
767444|NCT00696020|Secondary|AUC(0-3h,ss) Tiotropium [pg*h/mL]|Area under the concentration-time curve of Tiotropium at steady state (AUC(0-3h,ss)) from 0 to 3 hours post dosing after 4 weeks of treatment.|Pre-dose, 5 min, 10 min, 20 min, 40 min, 1 h, 3 h, and 6 h after the last dose.|Evaluable patients.||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
767449|NCT00696020|Secondary|Cmax,ss Olodaterol [pg/mL]|"Maximum measured concentration of Olodaterol in plasma at steady state (Cmax,ss) after 4 weeks of treatment.
No results displayed for Tiotropium+Olodaterol 5/2 μg because there were zero total participants analyzed for this outcome measure."|Pre-dose, 5 min, 10 min, 20 min, 40 min, 1 h, 3 h, and 6 h after the last dose.|Evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of PK or had insufficient data.||pg/mL||Geometric Coefficient of Variation|Geometric Mean
767450|NCT00696020|Secondary|Clinically Significant Anormalities (Laboratory Data); Marked Changes From Baseline for Vital Signs, Notable Change in ECG and New Onset of ECG Abnormalities|"Possible clinically significant anormalities (laboratory data); marked changes from baseline for vital signs, notable change in ECG and new onset of ECG abnormalities. New abnormal findings or worsening of baseline conditions were reported as Adverse Events (AEs).
All AEs with an onset after the first dose of study medication up to 21 days after the last dose of study medication were to have been assigned to the Treatment Period."|From first dose up to 21 days after last dose of study medication.|Treated Set.||participants|||Number
767451|NCT00696020|Secondary|Patient’s Global Rating|"Patient’s Global Rating at the end of the 4 week treatment period.
Patients rated their health (respiratory condition) at Day 29 (compared to the day before they commenced treatment with study medication) on a 7-point scale as “very much better (1), much better (2), a little better (3), no change (4), a little worse (5), much worse (6), or very much worse (7)”. The assessment was made prior to pulmonary function testing and all other study procedures. The Patient’s Global Rating was also completed before the Physician’s Global Evaluation.
The means are adjusted, based on an ANCOVA with terms for treatment, centre (centre random, treatment effect fixed)."|4 weeks|Full Analysis Set.||units on a patient's global rating score||Standard Error|Least Squares Mean
767452|NCT00696020|Secondary|Physician’s Global Evaluation|"Measured a 8-point scale, from 1 (poor) to 8 (excellent), as judged by the physician, over 4 weeks of treatment.
The physician made a global evaluation at the end of the Baseline Period (Test Day 1) and at each visit thereafter. These assessments were made prior to pulmonary function testing and reflected the physician’s opinion of the patient's overall clinical condition. This evaluation was based on the need for concomitant medication, number and severity of COPD exacerbations since the last visit, severity of cough, ability to exercise, amount of wheezing, and other relevant clinical observations.
The means are adjusted, based on an ANCOVA with terms for baseline, treatment, centre (centre random, all other effects fixed)."|1 week, 2 weeks and 4 weeks|Full Analysis Set.||units on a scale||Standard Error|Least Squares Mean
767453|NCT00696020|Secondary|Weekly Mean Number of Occasions of Rescue Therapy Used Per Day|The means are adjusted, Based on an ANCOVA with terms for baseline, treatment, centre (centre random, all other effects fixed).|Throughout the 4 weeks treatment period|Full Analysis Set.||occasion(s)||Standard Error|Least Squares Mean
767454|NCT00696020|Secondary|Weekly Mean Evening PEF [L/Min]|"The patient will record twice daily peak flow measurements using an AM2+ device. The evening measurement will be performed at bedtime.
The means are adjusted, based on an ANCOVA with terms for baseline, treatment, centre (centre random, all other effects fixed)."|Throughout the 4 weeks treatment period|Full Analysis Set.||L/min||Standard Error|Mean
767455|NCT00696020|Secondary|Weekly Mean Pre-dose Morning PEF [L/Min]|"The patient will record twice daily peak flow measurements using an Asthma Monitor®Am2+ (AM2+) device. Morning measurements will be performed immediately upon arising after the patient has cleared out mucus, prior to administration of trial and/or rescue medication.
The means are adjusted, based on an ANCOVA with terms for baseline, treatment, centre (centre random, all other effects fixed)."|Throughout the 4 week treatment period|Full Analysis Set.||L/min||Standard Error|Least Squares Mean
767456|NCT00696020|Secondary|PEF (Unsupervised) AUC(6-12h) Response [L/Min] After First Administration and 1,2 and 4 Weeks of Treatment|"PEF (peak expiratory flow rate L/min) AUC(6-12h) response is defined as change from the baseline value. AUC(6-12h) will be calculated as the area under the curve from 6 to 12 hours on the various test days using the trapezoidal rule, divided by the full duration (6 hours) to report in litres/min. Baseline was defined as the mean of the 2 pre-treatment values measured at Visit 2 (-1 h and -10 min) prior to administration of the first dose of study medication.
The means are adjusted, based on ANCOVA with terms for baseline, treatment, and centre (centre random, all other effects fixed).
Comparisons between groups are presented for Day 29."|6 h, 9 h and 12 h after inhalation at baseline and after 1 week, 2 weeks and 4 weeks|Full Analysis Set.||L/min||Standard Error|Least Squares Mean
767457|NCT00696020|Secondary|FEV1 (Unsupervised) AUC(6-12h) Response [L] After First Administration and 1,2 and 4 Weeks of Treatment|"FEV1 (forced expiratory volume in 1 second) AUC(6-12h) response is defined as change from the baseline value. AUC(6-12h) will be calculated as the area under the curve from 6 to 12 hours on the various test days using the trapezoidal rule, divided by the full duration (6 hours) to report in litres. Baseline was defined as the mean of the 2 pre-treatment values measured at Visit 2 (-1 h and -10 min) prior to administration of the first dose of study medication.
The means are adjusted, based on ANCOVA with terms for baseline, treatment, and centre (centre random, all other effects fixed).
Comparisons between groups are presented for Day 29."|6 h, 9 h and 12 h after inhalation at baseline and after 1 week, 2 weeks and 4 weeks|Full Analysis Set.||L||Standard Error|Least Squares Mean
767458|NCT00696020|Secondary|FEV1 and PEF (Unsupervised) AUC(0-6h) Response [L] After First Administration and After 1, 2 and 4 Weeks of Treatment|AUC(0-6h) for FEV1, and PEF (unsupervised) were not studied because the pertinent information from the unsupervised pulmonary function tests was for the time interval from 9 to 12 hours post-dosing.|After first administration, 1 week, 2 weeks and 4 weeks|Full Analysis Set.|||||
767459|NCT00696020|Secondary|PEF Peak(0-3h) Response [L] After First Administration and After 1, 2 and 4 Weeks of Treatment|"PEF (peak expiratory flow rate L/min) peak(0-3h) is the maximum post-dose value during the first 3 hours after first administration and after 1, 2 and 4 weeks of treatment. Response is defined as change from the baseline value. Baseline was defined as the mean of the 2 pre-treatment values measured at Visit 2 (-1 h and -10 min) prior to administration of the first dose of study medication.
The means are adjusted, based on an ANCOVA with terms for baseline, treatment, centre (centre random, all other effects fixed).
Comparisons between groups are presented for Day 29."|5 min (only for week 1 and 2), 30 min, 1 h, 2 h and 3 h after inhalation at baseline and after 1 week, 2 weeks and 4 weeks|Full Analysis Set.||L||Standard Error|Least Squares Mean
772210|NCT00733096|Secondary|Global Perceived Effect|Satisfaction. Number of participants with positive perceived global satisfaction.|1 month|Subjects who underwent epidural steroid injections||participants|||Number
767460|NCT00696020|Secondary|FVC Peak(0-3h) Response [L] After First Administration and After 1, 2 and 4 Weeks of Treatment|"FVC (forced vital capacity) peak(0-3h) is the maximum post-dose value during the first 3 hours after first administration and after 1, 2 and 4 weeks of treatment. Response is defined as change from the baseline value. Baseline was defined as the mean of the 2 pre-treatment values measured at Visit 2 (-1 h and -10 min) prior to administration of the first dose of study medication.
The means are adjusted, based on an ANCOVA with terms for baseline, treatment, centre (centre random, all other effects fixed).
Comparisons between groups are presented for Day 29."|5 min (only for week 1 and 2), 30 min, 1 h, 2 h and 3 h after inhalation at baseline and after 1 week, 2 weeks and 4 weeks|Full Analysis Set.||L||Standard Error|Least Squares Mean
767461|NCT00696020|Secondary|FEV1 Peak(0-3h) Response [L] After First Administration and After 1, 2 and 4 Weeks of Treatment|"FEV1 (forced expiratory volume in 1 second) peak(0-3h) is the maximum post-dose value during the first 3 hours after first administration and after 1, 2 and 4 weeks of treatment. Response is defined as change from the baseline value. Baseline was defined as the mean of the 2 pre-treatment values measured at Visit 2 (-1 h and -10 min) prior to administration of the first dose of study medication.
The means are adjusted, based on an ANCOVA with terms for baseline, treatment, centre (centre random, all other effects fixed).
Comparisons between groups are presented for Day 29."|5 min (only for week 1 and 2), 30 min, 1 h, 2 h and 3 h after inhalation at baseline and after 1 week, 2 weeks and 4 weeks|Full Analysis Set.||L||Standard Error|Least Squares Mean
767462|NCT00696020|Secondary|PEF AUC(0-6h) Response [L] After 4 Weeks of Treatment|"PEF (peak expiratory flow rate L/min) AUC(0-6h) response is defined as change from the baseline value. AUC(0-6h) will be calculated as the area under the curve from 0 to 6 hours on test day 29 using the trapezoidal rule, divided by the full duration (6 hours) to report in litres. Baseline was defined as the mean of the 2 pre-treatment values measured at Visit 2 (-1 h and -10 min) prior to administration of the first dose of study medication.
The means are adjusted, based on an ANCOVA with terms for baseline, treatment, centre (centre random, all other effects fixed)."|1 h and 10 min prior to inhalation at baseline and after 4 weeks and 30 min, 1 h, 2 h, 3 h, 4 h, 5 h and 6h after inhalation at baseline and after 4 weeks (Day 29)|Full Analysis Set.||L||Standard Error|Least Squares Mean
767463|NCT00696020|Secondary|FVC AUC(0-6h) Response [L] After 4 Weeks of Treatment|"FVC (forced vital capacity) AUC(0-6h) response is defined as change from the baseline value. AUC(0-6h) will be calculated as the area under the curve from 0 to 6 hours on test day 29 using the trapezoidal rule, divided by the full duration (6 hours) to report in litres. Baseline was defined as the mean of the 2 pre-treatment values measured at Visit 2 (-1 h and -10 min) prior to administration of the first dose of study medication.
The means are adjusted, based on an ANCOVA with terms for baseline, treatment, centre (centre random, all other effects fixed)."|1 h and 10 min prior to inhalation at baseline and after 4 weeks and 30 min, 1 h, 2 h, 3 h, 4 h, 5 h and 6h after inhalation at baseline and after 4 weeks (Day 29)|Full Analysis Set.||L||Standard Error|Least Squares Mean
767464|NCT00696020|Secondary|FEV1 AUC(0-6h) Response [L] After 4 Weeks of Treatment|"FEV1 (forced expiratory volume in 1 second) AUC(0-6h) response is defined as change from the baseline value. AUC(0-6h) will be calculated as the area under the curve from 0 to 6 hours on test day 29 using the trapezoidal rule, divided by the full duration (6 hours) to report in litres. Baseline was defined as the mean of the 2 pre-treatment values measured at Visit 2 (-1 h and -10 min) prior to administration of the first dose of study medication.
The means are adjusted, based on ANCOVA with terms for baseline, treatment, and centre (centre random, all other effects fixed)."|1 h and 10 min prior to inhalation at baseline and after 4 weeks and 30 min, 1 h, 2 h, 3 h, 4 h, 5 h and 6h after inhalation at baseline and after 4 weeks (Day 29)|Full Analysis Set.||L||Standard Error|Least Squares Mean
767465|NCT00696020|Secondary|PEF AUC(0-3h) Response [L/Min] After First Administration and After 1, 2 and 4 Weeks of Treatment.|"PEF (peak expiratory flow rate L/min) AUC(0-3h) response is defined as change from the baseline value. AUC(0-3h) will be calculated as the area under the curve from 0 to 3 hours on the various test days using the trapezoidal rule, divided by the full duration (3 hours) to report in litres/min. Baseline was defined as the mean of the 2 pre-treatment values measured at Visit 2 (-1 h and -10 min) prior to administration of the first dose of study medication.
The means are adjusted, based on an ANCOVA with terms for baseline, treatment, centre (centre random, all other effects fixed).
Comparisons between groups are presented for Day 29."|1 h and 10 min prior to inhalation and 5 min (only for week 1 and 2), 30 min, 1 h, 2 h and 3 h after inhalation at baseline and after 1, 2 and 4 weeks|Full Analysis Set.||L/min||Standard Error|Least Squares Mean
767466|NCT00696020|Secondary|FVC AUC(0-3h) Response [L] After First Administration and After 1, 2 and 4 Weeks of Treatment.|"FVC (forced vital capacity) AUC(0-3h) response is defined as change from the baseline value. AUC(0-3h) was calculated as the area under the curve from 0 to 3 hours on the various test days using the trapezoidal rule, divided by the full duration (3 hours) to report in litres. Baseline FVC was defined as the mean of the 2 pre-treatment FVC values measured at Visit 2 (-1 h and -10 min) prior to administration of the first dose of study medication.
The means are adjusted, based on an ANCOVA with terms for baseline, treatment, centre (centre random, all other effects fixed).
Comparisons between groups are presented for Day 29."|1 h and 10 min prior to inhalation and 5 min (only for week 1 and 2), 30 min, 1 h, 2 h and 3 h after inhalation at baseline and after 1, 2 and 4 weeks|Full Analysis Set.||L||Standard Error|Least Squares Mean
767467|NCT00696020|Secondary|FEV1 AUC(0-3h) Response [L] After First Administration and After 1, 2 and 4 Weeks of Treatment|"Response is defined as change from the baseline value. AUC(0-3h) (area under the curve) was calculated as the area under the curve from 0 to 3 hours on the various test days using the trapezoidal rule, divided by the full duration (3 hours) to report in litres. Baseline FEV1 was defined as the mean of the 2 pre-treatment FEV1 values measured at Visit 2 (-1 h and -10 min) prior to administration of the first dose of study medication
The means are adjusted, based on an ANCOVA with terms for baseline, treatment, centre (centre random, all other effects fixed).
Comparisons between groups are presented for Day 29."|1 h and 10 min prior to inhalation and 5 min (only for week 1 and 2), 30 min, 1 h, 2 h and 3 h after inhalation at baseline and after 1, 2 and 4 weeks|Full Analysis Set.||L||Standard Error|Least Squares Mean
767502|NCT00696410|Other Pre-specified|Change From Baseline in Serum Superoxide Dismutase|Change from baseline in serum superoxide dismutase after 10 months of zinc acetate in patients with systolic heart failure and compared with a single measure in healthy controls|Baseline (time 0) and 10 months|Specimens from healthy controls were only analyzed at one time frame.||units per microL||Inter-Quartile Range|Median
767468|NCT00696020|Secondary|Trough FVC Response [L] After 1, 2 and 4 Weeks of Treatment|"Trough FVC (forced vital capacity) was defined as the mean of the 2 FVC values (performed at 1 h and 10 min prior to study medication inhalation) at the end of the dosing interval, 24 hours post-drug administration. Trough FVC response was defined as the change from baseline in trough FVC. Baseline FVC was defined as the mean of the 2 pre-treatment FVC values measured at Visit 2 (-1 h and -10 min) prior to administration of the first dose of study medication.
The means are adjusted, based on an ANCOVA with terms for baseline, treatment, centre (centre random, all other effects fixed).
Comparisons between groups are presented for Day 29."|Baseline, 1 week, 2 weeks and 4 weeks|Full Analysis Set.||L||Standard Error|Least Squares Mean
767469|NCT00696020|Secondary|Trough FEV1 Response [L] After 1 and 2 Weeks of Treatment.|"Trough FEV1 (forced expiratory volume in 1 second) was defined as the mean of the 2 FEV1 values (performed at 1 h and 10 min prior to study medication inhalation) at the end of the dosing interval, 24 hours post-drug administration. Trough FEV1 response was defined as the change from baseline in trough FEV1. Baseline FEV1 was defined as the mean of the 2 pre-treatment FEV1 values measured at Visit 2 (-1 h and -10 min) prior to administration of the first dose of study medication.
The means are adjusted, based on ANCOVA with terms for baseline, treatment, centre (centre random, all other effects fixed).
Comparisons between groups are presented for Day 15."|Baseline, 1 week and 2 weeks|Full Analysis Set.||L||Standard Error|Least Squares Mean
767470|NCT00696020|Primary|Trough FEV1 Response [L] After 4 Weeks of Treatment|"Trough FEV1 (Forced expiratory volume in 1 second) was defined as the mean of the two FEV1 values (performed at 1 h and 10 min prior to study medication inhalation) at the end of the dosing interval, 24 hours post-drug administration. Trough FEV1 response was defined as the change from baseline in trough FEV1. Baseline FEV1 was defined as the mean of the 2 pre-treatment FEV1 values measured at Visit 2 (-1 h and -10 min) prior to administration of the first dose of study medication.
The means are adjusted, based on ANCOVA with terms for baseline, treatment, and centre (centre random, all other effects fixed)."|Baseline and 4 weeks|Full Analysis Set (FAS). The FAS consisted of all patients who received at least 1 dose of study medication and had baseline data (pre-treatment at the end of the 2-week baseline) for at least 1 efficacy endpoint. For this trial all randomized and treated patients were included in the FAS.||L||Standard Error|Least Squares Mean
767471|NCT00696072|Secondary|Number of Participants With Adverse Events (AEs) Leading to Discontinuation, Serious Adverse Events (SAEs), and Deaths|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|First dose of study drug to last dose plus 30 days, up to study completion (approximately 6 years)|All participants who received at least one dose of study drug were summarized. The participants were analyzed as per the treatment arm to which they were originally randomized.||participants|||Number
767472|NCT00696072|Secondary|Median Time to Treatment Failure (TTF) - ITT Population|Time to TTF was measured in months. The number of participants with events (PD or off treatment due to any reason) was evaluated. The first PD was defined as the event for cross over participants in the single- agent letrozole treatment arm to add dasatinib to their regimen.|First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years)|ITT population: All participants enrolled in the study.||Months||95% Confidence Interval|Median
767473|NCT00696072|Secondary|Percentage of Participants With PFS At 6 Months and At 12 Months - ITT Population|Progression=At least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. ITT population: from time of first enrollment to first PD for all ITT participants.|At 6 months and at 12 months|ITT population=Includes all participants registered on the study. n= number at risk||percentage of participants||95% Confidence Interval|Number
767474|NCT00696072|Secondary|Percentage of Participants Best Overall Response After Change From Letrozole to Letrozole Plus Dasatinib|Participants in single-agent letrozole treatment arm who developed progressive disease, could continue letrozole, and add dasatinib to their treatment regimen. CBR=participants with CR + participants with partial response (PR) + participants with SD for a length of time ≥6 months divided by the total number of participants (%). CR= Disappearance of all target lesions. No new lesions. PR= At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. SD= Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference the smallest sum LD since the treatment started. PD=At least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years)|Participants who changed their treatment regimen from single-agent letrozole to letrozole + dasatinib during the study.||percentage of participants||95% Confidence Interval|Number
767475|NCT00696072|Secondary|Median Progression Free Survival (PFS) - Intent to Treat (ITT) Population|PFS was measured in months. Progression=At least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Study initiated 2008 and completed 2014.|Day 1 to Study Completion (approximately 6 years)|ITT population includes all participants enrolled in the study. The participants were analyzed as per the treatment arm to which they were originally randomized.||months||95% Confidence Interval|Median
767476|NCT00696072|Secondary|Number of Participants With Complete Response, Partial Response, Stable Disease, and Disease Progression|CR= Disappearance of all target lesions. No new lesions. PR= At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. SD= Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference the smallest sum LD since the treatment started. Progression (PD): At least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years)|All treated participants who met the protocol-specified efficacy analyses requirements and who received at least 1 dose of study drug were analyzed. The participants are analyzed as per the treatment arm to which they were originally randomized.||participants|||Number
767477|NCT00696072|Primary|Number of Participants With Clinical Benefit (CBR) and Number of Participants With CBR Having a Disease Free Interval (DFI) Greater Than 2 Years - Evaluable Population|CBR=participants with complete response (CR) + participants with partial response (PR) + participants with stable disease (SD) for a length of time greater than, equal to 6 months. CR= Disappearance of all target lesions. No new lesions. PR= At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. SD= Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference the smallest sum LD since the treatment started. Physical examination,radiological assessment, and bone scans (if applicable) were used to assess outcome.|First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years)|Evaluable Population was defined as all treated participants who met the protocol-specified efficacy analyses requirements and who received at least 1 dose of randomized study drug. Participants presented in the treatment arm to which they were originally randomized.||participants|||Number
767478|NCT00696241|Secondary|Percentage of Participants Who Achieve Both a Clinic Diastolic and Systolic Blood Pressure Response|Percentage of participants who achieve both a clinic diastolic and systolic blood pressure response measured at week 6, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg AND less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Diastolic and systolic blood pressure is based on the arithmetic mean of the 3 sitting blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.||percentage of participants|||Number
767479|NCT00696241|Secondary|Percentage of Participants Who Achieve a Clinic Diastolic Blood Pressure Response, Defined as < 90 mm Hg and/or Reduction From Baseline ≥ 10 mm Hg|Percentage of participants who achieve a clinic diastolic blood pressure response measured at week 6, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg. Diastolic blood pressure is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.||percentage of participants|||Number
767480|NCT00696241|Secondary|Percentage of Participants Who Achieve a Clinic Systolic Blood Pressure Response, Defined as < 140 mm Hg and/or Reduction From Baseline ≥ 20 mm Hg|Percentage of participants who achieve a clinic systolic blood pressure response measured at week 6, defined as less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.||percentage of participants|||Number
767481|NCT00696241|Secondary|Change From Baseline in the Trough (22-24-hr) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 6.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
767482|NCT00696241|Secondary|Change From Baseline in the Trough (22-24-hr) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 6.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
767483|NCT00696241|Secondary|Change From Baseline in the 12-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring|The change in the 12-hour mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 6.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
767484|NCT00696241|Secondary|Change From Baseline in the 12-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring|The change in the 12-hour mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 6.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
767485|NCT00696241|Secondary|Change From Baseline in the Nighttime (12 am to 6 am) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 6.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
767486|NCT00696241|Secondary|Change From Baseline in the Nighttime (12 am to 6 am) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 6.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
767487|NCT00696241|Secondary|Change From Baseline in Daytime (6am to 10 pm) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 6.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
767503|NCT00696410|Other Pre-specified|Change in PIIINP From Baseline After 10 Months of Zinc Acetate in Systolic Heart Failure and Compared With a Single Measure in Healthy Controls|Change in PIIINP from baseline after 10 months of Zinc Acetate in patients with systolic heart failure and compared with a single measure in healthy controls|Baseline (time 0) and 10 months|Specimens from healthy controls were only analyzed at one time frame.||ng/ml||Inter-Quartile Range|Median
767488|NCT00696241|Secondary|Change From Baseline in Daytime (6am to 10 pm) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 6.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
767489|NCT00696241|Secondary|Change From Baseline in Mean Trough Clinic Sitting Diastolic Blood Pressure|The change in mean trough clinic sitting diastolic blood pressure measured at final visit or week 6 relative to baseline.|Baseline and Week 6.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
767490|NCT00696241|Secondary|Change From Baseline in the 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 6.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
767491|NCT00696241|Secondary|Change From Baseline in Mean Trough Clinic Sitting Systolic Blood Pressure|The change in mean trough clinic sitting systolic blood pressure measured at final visit or week 6 relative to baseline.|Baseline and Week 6.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
767492|NCT00696241|Primary|Change From Baseline in the 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 6.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
767493|NCT00696293|Primary|Change in McGill Pain Questionaire, Short Form, Score From Baseline and 12 Weeks|"The McGill Pain Questionaire, short form consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. The McGill Pain Questionaire score ranged from 0 (none) to 45 (severe).
A larger reduction of the score from baseline to 12 weeks would represent a better outcome"|Baseline and 12 weeks|||units on a scale||Standard Deviation|Mean
767494|NCT00696293|Primary|Change in Montgomery Asberg Depression Rating Scale(MADRS) Score From Baseline and 12 Weeks|"The MADRS is a rating of depression severity with theoretical scale range 0-60, with lower values representing better outcome
Larger reduction between MADRS from baseline to 12 weeks would represent better outcome"|baseline and 12 weeks|description of median change||units on a scale||Standard Deviation|Mean
767495|NCT00696384|Secondary|Number of Participants With Adverse Events in the Double-Blind Baseline Phase|Treatment-emergent adverse events defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after last dose of study drug, or within 30 days after the last dose of study drug for SAE. A SAE is defined as any untoward medical occurrence that either results in death; is life-threatening; requires hospitalization; results in persistent or significant disability/incapacity; leads to a congenital anomaly/birth defect; or is an important medical event.|Double-blind Baseline/Week 26 to Week 32|||participants|||Number
767496|NCT00696384|Secondary|Number of Participants With Adverse Events During the Open-Label Phase|Treatment-emergent adverse events defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after last dose of study drug, or within 30 days after the last dose of study drug for serious adverse event (SAE). A SAE is defined as any untoward medical occurrence that either results in death; is life-threatening; requires hospitalization; results in persistent or significant disability/incapacity; leads to a congenital anomaly/birth defect; or is an important medical event.|Baseline to Week 26|||participants|||Number
767497|NCT00696384|Secondary|Change From Open Label Baseline (Week 0) in Sitting Clinic Systolic Blood Pressure to Week 26|The change from baseline in sitting clinic systolic blood pressure measured at final visit or week 26.|Baseline and Week 26.|Safety analysis set with last observation carried forward.||mmHg||Standard Deviation|Mean
767498|NCT00696384|Secondary|Change From Open Label Baseline (Week 0) in Sitting Clinic Diastolic Blood Pressure to Week 26|The change from baseline in sitting clinic diastolic blood pressure measured at final visit or week 26.|Baseline and Week 26.|Safety analysis set with last observation carried forward.||mmHg||Standard Deviation|Mean
767499|NCT00696384|Secondary|Change From Double-blind Baseline (Week 26) in Sitting Clinic Systolic Blood Pressure to Week 32|The change in sitting clinic systolic blood pressure measured at final visit or week 32 from Double-blind Baseline/Week 26.. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements. Each participant's blood pressure at the Final Visit/Week 26 of the open-label phase represented their Baseline blood pressure for the double-blind reversal phase.|Double-blind Baseline (Week 26) and Week 32.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
767500|NCT00696384|Primary|Change From Double-blind Baseline (Week 26) in Sitting Clinic Diastolic Blood Pressure to Week 32|The change in sitting clinic diastolic blood pressure measured at final visit or week 32 from Double-blind Baseline/Week 26. Diastolic blood pressure is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements. Each participant's blood pressure at the Final Visit/Week 26 of the open-label phase represented their Baseline blood pressure for the double-blind reversal phase.|Double-blind Baseline (Week 26) and Week 32.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
767501|NCT00696410|Other Pre-specified|Change From Baseline in Serum Measures of of Myeloperoxidase (MPO) After 10 Months of Zinc Acetate Treatment|Change from baseline in serum myeloperoxidase (MPO) after 10 months of zinc acetate treatment in patients with systolic heart failure and compared with a single measure from healthy controls|Baseline (time 0) and 10 months|Healthy controls only analyzed at one time point||units per L||Inter-Quartile Range|Median
767727|NCT00697593|Primary|Biochemistry - C-Reactive Protein (CRP)|Blood samples were taken for clinical laboratory testing of the numbers of participants with CRP values <3 mg/L, 3-6 mg/L, and >6 mg/L|Week 12 / Early Termination|Safety Population - 1 participant with missing values||participants|||Number
767505|NCT00696410|Primary|Change From Baseline in Markers of Cardiac Collagen Turnover (PINP) in Patients With Systolic Heart Failure and Compared With Healthy Controls.|The intervention group (patients with systolic heart failure) was given Zinc Acetate 50 mg po three times daily for 10 months. The change from baseline in markers of cardiac collagen turnover (PINP) in patients with systolic heart failure after 10 months of zinc acetate was measured and compared with a single measure from healthy controls.|Baseline (time 0) and after 10 months of Zinc Acetate.|Power was determined using prior studies examining the change in PINP and (separately) PIIINP in heart failure following administration of aldactone. Results below are PINP.||ng/ml||Inter-Quartile Range|Median
767506|NCT00696423|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in isability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|During the 31-day follow-up period after booster vaccination|||subjects|||Number
767507|NCT00696423|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|During the 31-day follow-up period after booster vaccination|||subjects|||Number
767508|NCT00696423|Secondary|Number of Subjects Reporting Solicited Local and General Symptoms|Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include drowsiness, fever, irritability, and loss of appetite.|During the 4-day follow-up period after booster vaccination|Analysis was performed on subjects from the Total Vaccinated Cohort with a documented dose.||subjects|||Number
767509|NCT00696423|Secondary|The Number of Subjects Seroprotected for Anti-PRP, Anti-diphtheria and Anti-tetanus Antibodies and Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies|Assay cut-offs indicating seroprotection or seropositivity for the different antigens were the following: anti-PRP antibody concentrations ≥ 0.15 µg/mL, anti-diphtheria and anti-tetanus antibody concentrations ≥ 0.1 IU/mL, anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 20 EL.U/mL.|Before booster vaccination|Analysis was performed on the ATP cohort for immunogenicity.||subjects|||Number
767510|NCT00696423|Secondary|Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations|Geometric mean concentrations are given in EL.U/mL.|Before booster vaccination|Analysis was performed on the ATP cohort for immunogenicity.||EL.U/mL||95% Confidence Interval|Geometric Mean
767511|NCT00696423|Secondary|Anti-tetanus Toxoid Antibody Concentrations|Geometric mean concentrations are given in IU/mL.|Before booster vaccination|Analysis was performed on the ATP cohort for immunogenicity.||IU/mL||95% Confidence Interval|Geometric Mean
767512|NCT00696423|Secondary|Anti-diphtheria Toxoid Antibody Concentrations|Geometric mean concentrations are given in IU/mL.|Before booster vaccination|Analysis was performed on the ATP cohort for immunogenicity.||IU/mL||95% Confidence Interval|Geometric Mean
767513|NCT00696423|Secondary|Anti-PRP Antibody Concentrations|Geometric mean concentrations are given in μg/mL.|Before booster vaccination|Analysis was performed on the ATP cohort for immunogenicity.||μg/mL||95% Confidence Interval|Geometric Mean
767514|NCT00696423|Primary|The Number of Subjects Seroprotected for Anti-PRP, Anti-diphtheria and Anti-tetanus Antibodies and Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies|Assay cut-offs indicating seroprotection or seropositivity for the different antigens were the following: anti-PRP antibody concentrations ≥ 0.15 µg/mL, anti-diphtheria and anti-tetanus antibody concentrations ≥ 0.1 IU/mL, anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 20 EL.U/mL.|One month after booster vaccination|Analysis was performed on the ATP cohort for immunogenicity.||subjects|||Number
767515|NCT00696423|Primary|Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations|Geometric mean concentrations are given in Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per milliliter (EL.U/mL).|One month after booster vaccination|Analysis was performed on the ATP cohort for immunogenicity.||EL.U/mL||95% Confidence Interval|Geometric Mean
767516|NCT00696423|Primary|Anti-tetanus Toxoid Antibody Concentrations|Geometric mean concentrations are given in IU/mL.|One month after booster vaccination|Analysis was performed on the ATP cohort for immunogenicity.||IU/mL||95% Confidence Interval|Geometric Mean
767517|NCT00696423|Primary|Anti-diphtheria Toxoid Antibody Concentrations|Geometric mean concentrations are given in international Unit per milliliter (IU/mL).|One month after booster vaccination|Analysis was performed on the ATP cohort for immunogenicity.||IU/mL||95% Confidence Interval|Geometric Mean
767518|NCT00696423|Primary|Anti-polyribosyl-ribitol-phosphate (PRP) Antibody Concentrations|Geometric mean concentrations are given in microgram per milliliter (μg/mL).|One month after booster vaccination|Analysis was performed on the According To Protocol (ATP) cohort for immunogenicity.||μg/mL||95% Confidence Interval|Geometric Mean
767519|NCT00696436|Secondary|Percentage of Participants Who Achieve Both a Clinic Diastolic and Systolic Blood Pressure Response|Percentage of participants who achieve both a clinic diastolic and systolic blood pressure response measured at week 6, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg AND less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Diastolic and systolic blood pressure is based on the arithmetic mean of the 3 sitting blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.||percentage of participants|||Number
767520|NCT00696436|Secondary|Percentage of Participants Who Achieve a Clinic Diastolic Blood Pressure Response, Defined as < 90 mm Hg and/or Reduction From Baseline ≥ 10 mm Hg|Percentage of participants who achieve a clinic diastolic blood pressure response measured at week 6, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg. Diastolic blood pressure is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.||percentage of participants|||Number
767521|NCT00696436|Secondary|Percentage of Participants Who Achieve a Clinic Systolic Blood Pressure Response, Defined as < 140 mm Hg and/or Reduction From Baseline ≥ 20 mm Hg|Percentage of participants who achieve a clinic systolic blood pressure response measured at week 6, defined as less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.||percentage of participants|||Number
767522|NCT00696436|Secondary|Change From Baseline in the Trough (22-24-hr) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
767523|NCT00696436|Secondary|Change From Baseline in the Trough (22-24-hr) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
767524|NCT00696436|Secondary|Change From Baseline in the 12-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 12-hour mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
767525|NCT00696436|Secondary|Change From Baseline in the 12-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 12-hour mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
767526|NCT00696436|Secondary|Change From Baseline in the Nighttime (12 am to 6 am) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
767527|NCT00696436|Secondary|Change From Baseline in the Nighttime (12 am to 6 am) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
767528|NCT00696436|Secondary|Change From Baseline in Daytime (6am to 10 pm) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
767529|NCT00696436|Secondary|Change From Baseline in Daytime (6am to 10 pm) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
767530|NCT00696436|Secondary|Change From Baseline in Mean Trough Clinic Sitting Diastolic Blood Pressure|The change in mean trough clinic sitting systolic blood pressure measured at final visit or week 6 relative to baseline.|Baseline and Week 6.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
767531|NCT00696436|Secondary|Change From Baseline in the 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
767532|NCT00696436|Secondary|Change From Baseline in Mean Trough Clinic Sitting Systolic Blood Pressure.|The change in mean trough clinic sitting systolic blood pressure measured at final visit or week 6 relative to baseline.|Baseline and Week 6.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
767533|NCT00696436|Primary|Change From Baseline in the 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
767534|NCT00696449|Primary|Adherence to Treatment|Percentage of prescribed doses taken over the 12-week study period, as measured by a Medication Event Monitoring System (MEMS) cap|12 weeks|||Percent of prescribed doses||Full Range|Median
767535|NCT00696488|Primary|Adherence to Carac® in Subjects With Moderate to Severe Actinic Keratosis.|Measure of adherence by MEMS caps and the % of total prescribed doses that were actually used|12 weeks|||percentage of prescribed doses||Full Range|Mean
767536|NCT00696618|Secondary|D(Average) at Two Hours|Mean proximal residence distance of radio-signal from anus as measured on SPECT/CT|two hours following dosing of intervention|All participants who received one dose of each intervention and completed all study visits were included in the analysis.||centimeters||Inter-Quartile Range|Median
767537|NCT00696618|Secondary|Radiolabel Area Under the Curve (AUC 0-24 hr)|Percent of radiolabel dose administered was determined by plasma sampling at standardized intervals over 24 hours. AUC was then calculated using the trapezoidal rule and reported as x10 log 7 microcurie-hours/mL|24 hours following each intervention|All participants who received one dose of each intervention and completed all study visits were included in the analysis.||10 log 7 microcurie-hours/mL||Inter-Quartile Range|Median
767538|NCT00696618|Primary|Mucosal Toxicity Using Histopathology|"Endoscopy will be performed to obtain biopsy specimens at baseline and following each inpatient enema exposure. Samples will be obtained at each flexible sigmoidoscopy and set aside for batch sectioning and H&E staining. Slides will be reviewed and scored by a qualified pathologist blinded to treatment assignment using a qualitative scoring system. This scoring system uses semi-quantitative scoring that focuses on acute toxicity to epithelial cell layer similar to that seen in animal studies. This is a categorical grading scale, where 0 = Epithelial surface intact;1 = <1/3 of surface denuded; 2 = 1/3 - 2/3rds of surface denuded;3 = More than 2/3rds of surface denuded.
Six separate biopsies for each subject and each treatment intervention were analyzed in a multi-level analysis. In comparison with the baseline condition (no intervention), the odds and 95% confidence interval (CI) of having a higher epithelial denudation score were calculated for each intervention."|One hour following enema exposure|All participants who received one dose of each intervention and completed all study visits were included in the analysis.||units on a scale|colon biopsies|95% Confidence Interval|Geometric Mean
767539|NCT00696696|Secondary|Median Overall Survival (mOS)|Median overall survival is defined as the time when 50% of the patients are alive from the start of the treatment.|up to 2 years|Based on the number of patients treated.||days||95% Confidence Interval|Median
767540|NCT00696696|Secondary|Objective Response Rate|The response rate is the percentage of the patients who have a complete response or partial response based on RECIST from the start of the treatment. The response is evaluated every 2 cycles by radiologic methods (e.g., computer tomography (CT)).|up to 1 year|Based on the number of patients evaluable for response. The evaluable patients were those patients who received any treatment and had first response assessment followed by at least one confirmatory scan.||percentage of patients|||Number
767541|NCT00696696|Primary|4-month Progression Free Survival (PFS) Rate|The PFS rate at 4 months is defined as the percentage of patients whose disease is progression free at 4 months from the start of treatment. Disease progression is evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) (Therasse et al, 2000). Radiological measurements to determine progression is performed every 2 cycles.|4 months|Based on the number of patients treated.||percentage of patients|||Number
767542|NCT00696761|Primary|Treatment Efficacy Was Analyzed by Validated Symptom Scores.|Alfuzosin was administered daily (10 mg). After 12 months of treatment, efficacy and safety were analyzed. Efficacy was measured by validated symptom scores (using IPSS ). IPSS score change was measured pre- and post- treatment.|12 month|The population analyzed included participants receiving drug for 12 months||score||Standard Deviation|Mean
767543|NCT00696761|Secondary|Changes of International Continence Society (ICS)-Male Questionnaire, Uroflowmetry, Residual Urine Volume, and Patient's Global Impression of Improvement||3month, 6month, 12month||||||
767544|NCT00696761|Primary|Primary Outcome; International Prostate Symptom Score Changes Between 4 Groups Compared to Baseline After 12 mo Treatment|"international prostate symptom score was measured at baseline and 12 months. total scores on a scale range (from 0 to 35) higher values represent a worse outcome
Baseline score minus 12-month score"|12months|||score||Standard Deviation|Mean
767545|NCT00696774|Secondary|Change From Baseline in the Sheehan Disability Scale (SDS) at 4 and 8 Weeks|The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Total scores range from 0 to 30 with higher values indicating greater disruption in the patient's work/social/family life. Factors used for adjustment for least squares means are listed in 'Other relevant information' section.|Baseline, 4 weeks, 8 weeks|"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group Unclassified was excluded from statistical testing."||Units on a scale||95% Confidence Interval|Least Squares Mean
767546|NCT00696774|Secondary|Change From Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM) at 4 and 8 Weeks|The TSQM is a participant-reported measure that best describes how the study medication makes them feel since the last study visit, assessing perceived effectiveness, severity of side effects, and convenience. Convenience, Effectiveness, Side-Effects, and Global Satisfaction scale scores range from 0 (extremely dissatisfied) to 100 (extremely satisfied). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.|Baseline, 4 weeks, 8 weeks|"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group Unclassified was excluded from statistical testing."||Units on a scale||95% Confidence Interval|Least Squares Mean
767547|NCT00696774|Secondary|Change From Baseline in the Sexual Functioning Questionnaire Clinical Version (CSFQ) at 4 and 8 Weeks|A 14-item patient-rated scale assesses medication-related changes in sexual activity/functioning. Items rated from 1 (never, low enjoyment/pleasure) to 5 (every day, great enjoyment/pleasure). CSFQ measures 5 dimensions of sexual behavior: pleasure; desire/frequency; desire/interest; arousal; orgasm. Lower total scores are associated with diminished sexual functioning. Total scores <=47 (men) and <=41 (women) indicate global sexual dysfunction, with all phases of sexual response cycle affected. Factors used for adjustment for least squares means are in 'Other relevant information' section.|Baseline, 4 Weeks, 8 weeks|"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group Unclassified was excluded from statistical testing."||Units on a scale||95% Confidence Interval|Least Squares Mean
767548|NCT00696774|Secondary|Change From Baseline in Patient Global Impression - Improvement (PGI–I) Scale Score at 8 Weeks|A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.|8 weeks|"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group Unclassified was excluded from statistical testing."||Units on a scale||95% Confidence Interval|Least Squares Mean
767549|NCT00696774|Secondary|Change From Baseline in the Brief Pain Inventory - Modified Short Form (BPI-SF) Average Pain Score at 8 Weeks|A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.|Baseline, 8 weeks|"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group Unclassified was excluded from statistical testing."||Units on a scale||95% Confidence Interval|Least Squares Mean
767550|NCT00696774|Secondary|Change From Baseline in the Clinical Global Impression – Severity (CGI-Severity) Scale at 8 Weeks|Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.|Baseline, 8 weeks|"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group Unclassified was excluded from statistical testing."||Units on a scale||95% Confidence Interval|Least Squares Mean
767551|NCT00696774|Secondary|Change From Baseline in the Hamilton Anxiety Rating Scale (HAMA) at 8 Weeks|The HAMA scale measures anxiety symptoms accompanying major depressive disorder (MDD). Each item of the 14-item HAMA was scored from 0 (not present) to 4 (very severe), with a resulting maximum total score of 56. Factors used for adjustment for least squares means are listed in 'Other relevant information' section.|Baseline, 8 weeks|"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group Unclassified was excluded from statistical testing."||Units on a scale||95% Confidence Interval|Least Squares Mean
767552|NCT00696774|Secondary|Change From Baseline HAMD-17 Sleep Subscale at 8 Weeks|The Sleep Subscale (Items 4,5,6) evaluates initial, middle, and late insomnia. Total subscale scores range from 0 (no difficulty) to 6 (difficulty). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.|Baseline, 8 weeks|"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group Unclassified was excluded from statistical testing."||Units on a scale||95% Confidence Interval|Least Squares Mean
767553|NCT00696774|Secondary|Change From Baseline HAMD-17 Retardation/Somatization Subscale at 8 Weeks|The Retardation Subscale (Items 1,7,8,14) evaluates dysfunction in mood, work, and sexual activity, as well as overall motor retardation. Total subscale scores range from 0 (normal) to 14 (severe). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.|Baseline, 8 weeks|"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group Unclassified was excluded from statistical testing."||Units on a scale||95% Confidence Interval|Least Squares Mean
767554|NCT00696774|Secondary|Change From Baseline HAMD-17 Anxiety/Somatization Subscale at 8 Weeks|The Anxiety/Somatization Subscale (Items 10-13, 15, 17) evaluates severity of psychic and somatic manifistations of anxiety as well as agitation. Total subscale scores range from 0 (normal) to 18 (severe). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.|Baseline, 8 weeks|"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group Unclassified was excluded from statistical testing."||Units on a scale||95% Confidence Interval|Least Squares Mean
767555|NCT00696774|Secondary|Change From Baseline HAMD-17 Maier Subscale at 8 Weeks|"The Maier subscale (Items 1,2,7,8,9,10) represents the core symptoms of depression. Total subscale scores range from 0 (normal) to 24 (severe). Factors used for adjustment for least squares means are listed in 'Other relevant information' section."|Baseline, 8 weeks|"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group Unclassified was excluded from statistical testing."||Units on a scale||95% Confidence Interval|Least Squares Mean
767556|NCT00696774|Secondary|Change From Baseline HAMD-17 Core Subscale at 8 Weeks|"The Core subscale (Items 1,2,3,7,8) evaluates core symptoms of depression. Total subscale scores range from 0 (normal) to 20 (severe). Factors used for adjustment for least squares means are listed in 'Other relevant information' section."|Baseline, 8 weeks|"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group Unclassified was excluded from statistical testing."||Units on a scale||95% Confidence Interval|Least Squares Mean
767557|NCT00696774|Secondary|Change From Baseline HAMD-17 Total Score at 8 Weeks|The HAMD-17 total score measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.|Baseline, 8 weeks|"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group Unclassified was excluded from statistical testing."||Units on a scale||95% Confidence Interval|Least Squares Mean
767558|NCT00696774|Secondary|Percentage of Participants Meeting Criteria for Response on the 17-Item Hamilton Depression Rating Scale (HAMD-17) Maier Subscale at 4 and 8 Weeks|"The Maier subscale (Items 1,2,7,8,9,10) represents the core symptoms of depression. Total subscale scores range from 0 (normal) to 24 (severe). Response is defined as a >=50% reduction in the Maier subscale score from baseline."|Baseline, 4 weeks, 8 weeks|"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group Unclassified was excluded from statistical testing."||Percentage of participants||95% Confidence Interval|Number
767559|NCT00696774|Primary|Change From Baseline in Brief Pain Inventory-Modified Short Form (BPI-SF) Interference Score Between Responder and Non-Responder Participants at 4 Weeks|"BPI-SF interference score asks about the degree to which pain interferes with mood, walking and other physical activity, work, social activity, relations with others, and sleep. BPI-SF interference score ranges from 0 (no interference) to 10 (interferes completely). Response is defined as a >=50% reduction in the Maier subscale score from baseline. The Maier subscale (Items 1,2,7,8,9,10) represents core symptoms of depression. Total subscale scores range from 0 (normal) to 24 (severe). Factors used for adjustment for least squares means are listed in 'Other relevant information' section."|Baseline, 4 weeks|"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group Unclassified was excluded from statistical testing."||Units on a scale||95% Confidence Interval|Least Squares Mean
767570|NCT00696800|Secondary|Number of Oocytes Assessed Prior to Intracytoplasmic Sperm Injection (ICSI)|The number of oocytes used for ICSI was assessed, and categorized based on their quality|Up to 36 hours after administration of hCG (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa (Cori Alfa) or recFSH, and grouped according to the treatment they were randomized to. For participants who had ICSI; but also includes 3 participants whose oocytes were assessed, but ICSI was not performed.||Number of oocytes||Standard Deviation|Mean
767560|NCT00696787|Secondary|Change From Baseline on the Numeric Rating Scale (NRS) in the Treatment of Pain Associated With Fibromyalgia in Adult Female Outpatients|The efficacy variable was the change from baseline on the numeric rating scale (NRS). The time point was the average pain score during the last data-analysis-interval of week 8, data analysis interval. The baseline score was the average of the NRS scores across the last 7 days of the screening period (just prior to the start of the placebo run-in). The efficacy variable was the pain severity score measured on an 11 point NRS on which 0=no pain and 10=worst possible pain.|Baseline and 8 weeks|All randomized subjects who had taken at least one dose of double-blind test article, had a baseline primary efficacy evaluation, and had at least one primary efficacy evaluation on double-blind therapy. Subjects who did not complete the study due to its discontinuation were excluded.||units on scale||Standard Error|Mean
767561|NCT00696787|Primary|Change From Baseline on the Numeric Rating Scale (NRS)|The primary efficacy variable was the change from baseline on the NRS. The primary time point was the average pain score during the last data-analysis-interval of week 8. The baseline score was the average of the NRS scores across the last 7 days of the screening period (just prior to the start of the placebo run-in). The primary efficacy variable was the pain severity score measured on an 11 point NRS on which 0=no pain and 10=worst possible pain.|Baseline and 8 weeks|The Modified Intent to Treat (MITT) population included all randomized subjects who had taken at least one dose of double-blind test article, who had a baseline primary efficacy evaluation, and who had at least one primary efficacy evaluation on double-blind therapy.||units on scale||Standard Error|Mean
767562|NCT00696800|Secondary|Percentage of Participants With a Biochemical Pregnancy (Pregnancy Rate) Per Embryo Transfer|Biochemical pregnancy was assessed for participants who had embryo transfer by measuring serum or urinary hCG. The pregnancy rate is 100 times the number of participants with pregnancies detected, divided by the number of participants assessed.|Two weeks after embryo transfer (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants with embryo transfer.||Percentage of participants|||Number
767563|NCT00696800|Secondary|Percentage of Participants With a Biochemical Pregnancy (Pregnancy Rate) Per Attempt|Biochemical pregnancy was assessed by measuring serum or urinary hCG. Per attempt means that if a participant did not reach the stage of pregnancy assessment zero values were imputed. The pregnancy rate is 100 times the number of participants with pregnancies detected, divided by the number of participants assessed.|Two weeks after embryo transfer (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to.||Percentage of participants|||Number
767564|NCT00696800|Secondary|Percentage of Participants With a Miscarriage (Miscarriage Rate) Per Vital Pregnancy|The miscarriage rate is 100 times the number of miscarriages, divided by the number of vital pregnancies assessed by USS. A vital pregnancy is the presence of at least one fetus with heart activity.|Up to day of miscarriage (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants with a vital pregnancy.||Percentage of participants|||Number
767565|NCT00696800|Secondary|Percentage of Participants With a Miscarriage (Miscarriage Rate) Per Clinical Pregnancy|The miscarriage rate is 100 times the number of miscarriages, divided by the number of clinical pregnancies assessed by USS. A clinical pregnancy is the presence of at least one gestational sac or confirmed by live birth.|Up to day of miscarriage (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants with a clinical pregnancy.||Percentage of participants|||Number
767566|NCT00696800|Secondary|Percentage of Gestational Sacs (Implantation Rate)|The implantation rate is 100 times the number of gestational sacs assessed by USS after embryo transfer, divided by the number of embryos transferred.|Up to 6 weeks after embryo transfer (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants with embryo transfer.||Percentage of gestational sacs||Standard Deviation|Mean
767567|NCT00696800|Secondary|Number of Embryos Transferred on Day 3|After fertilization, the mean number of embryos transferred on Day 3 were assessed. Total and good quality embryos are presented, with good quality embryos, Grades 1 and 2, defined as the following: Grade 1: excellent: No fragmentation, 6-10 cells, and equal blastomere size taking the impact of cell division into account. Grade 2: good: < 20% fragmentation, 6-10 cells, and equal blastomere size taking the impact of cell division into account.|Post fertilization Day 3 (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants with embryo transfer.||Number of embryos||Standard Deviation|Mean
767568|NCT00696800|Secondary|Number of Embryos Obtained on Day 3 Categorized by Quality|Embryos obtained on Day 3 were categorized by their qualiity as follows: Grade 1: excellent: No fragmentation, 6-10 cells, and equal blastomere size taking the impact of cell division into account. Grade 2: good: < 20% fragmentation, 6-10 cells, and equal blastomere size taking the impact of cell division into account. Grade 3: fair: 20-50% fragmentation and/or less than 6 cells and/or multinucleation (if observed). Other Grade: Embryos that do not qualify as Grades 1, 2 or 3. Grades 1 and 2 are considered good quality.|Post fertilization Day 3 (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants with IVF and/or ICSI, and excludes those who had embryos transferred or cryopreserved before Day 3.||Number of embryos||Standard Deviation|Mean
767569|NCT00696800|Secondary|Percentage of Fertilized Oocytes (Fertilization Rate)|The fertilization rate is 100 times the number of fertilized 2 pro-nuclei (2PN) oocytes obtained, divided by the number of oocytes fertilized by IVF or ICSI|Up to 18 hours after start of fertilization (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to.Restricted to participants with IVF and/or ICSI.||Percentage of fertilized oocytes||Standard Deviation|Mean
767728|NCT00697593|Primary|Biochemistry - Urea|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 1 participant missing values||mmol/L||Standard Deviation|Mean
767571|NCT00696800|Secondary|Number of Cumulus-oocyte-complexes|Prior to IVF the mean number of cumulus-oocyte-complexes used for IVF was assessed|Up to 36 hours after administration of hCG (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants who underwent IVF.||Number of cumulus-oocyte complexes||Standard Deviation|Mean
767572|NCT00696800|Secondary|Number of Follicles Categorized by Size on the Day of hCG|Ovaries were assessed during stimulation by USS, and the mean number of follicles are categorized by their size.|Day of HCG treatment (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants with hCG injection and with USS data available.||Number of follicles||Standard Deviation|Mean
767573|NCT00696800|Secondary|Number of Follicles Categorized by Size on Stimulation Day 8|Ovaries were assessed during stimulation by USS, and the mean number of follicles are categorized by their size.|On Day 8 of treatment (up to 1 year)|ITT population (consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to) with USS data available on Stimulation Day 8.||Number of follicles||Standard Deviation|Mean
767574|NCT00696800|Secondary|Number of Follicles Categorized by Size on Stimulation Day 5|Ovaries were assessed during stimulation by USS, and the mean number of follicles are categorized by their size.|On Day 5 of treatment (up to 1 year)|ITT population (consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to) with USS data available on Stimulation Day 5.||Number of follicles||Standard Deviation|Mean
767575|NCT00696800|Secondary|Number of Follicles Categorized by Size on Stimulation Day 1|Ovaries were assessed during stimulation by ultrasonographic investigation (USS), and the mean number of follicles are categorized by their size.|On Day 1 of treatment (up to 1 year)|ITT population (consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to) with USS data available on Stimulation Day 1.||Number of follicles||Standard Deviation|Mean
767576|NCT00696800|Secondary|Serum Inhibin-B Levels During Stimulation|Mean serum Inhibin-B levels are presented over one COS cycle: from Day 1 (Pre-dose) up to day of hCG treatment|Up to day of hCG treatment (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa (Cori Alfa) or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants who had Inhibin-B data available.||pg/mL||Standard Deviation|Mean
767577|NCT00696800|Secondary|Serum Progesterone (P) Levels During Stimulation|Mean serum P levels are presented over one COS cycle: from Day 1 (Pre-dose) up to day of hCG treatment|Up to day of hCG treatment (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa (Cori Alfa) or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants who had P data available.||nmol/mL||Standard Deviation|Mean
767578|NCT00696800|Secondary|Serum Estradiol (E2) Levels During Stimulation|Mean serum E2 levels are presented over one COS cycle: from Day 1 (Pre-dose) up to the day of hCG treatment.|Up to day of hCG treatment (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa (Cori Alfa) or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants who had E2 data available.||pmol/L||Standard Deviation|Mean
767579|NCT00696800|Secondary|Serum Luteinizing Hormone (LH) Levels During Stimulation|Mean serum LH levels are presented over one COS cycle: from Day 1 (Pre-dose) up to the day of hCG treatment.|Up to day of hCG treatment (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa (Cori Alfa) or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants who had LH data available.||IU/L||Standard Deviation|Mean
767580|NCT00696800|Secondary|Serum FSH Levels During Stimulation|Mean serum FSH are presented over one Controlled Ovarian Stimulation (COS) cycle: from Day 1 (Pre-dose) up to the day of hCG treatment.|Up to day of hCG treatment (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa (Cori Alfa) or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants who had FSH data available.||IU/L||Standard Deviation|Mean
767581|NCT00696800|Secondary|Median Amount of Recombinant FSH Needed to Induce Multifollicular Development Starting at Day 8|The amount of recFSH administered for a participant to reach 3 follicles >= 17 mm, starting from treatment Day 8 onwards.|From Day 8 to Day of hCG treatment (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants with hCG injection.||IU||Full Range|Median
767582|NCT00696800|Secondary|Median Amount of Recombinant FSH Needed to Induce Multifollicular Development Starting at Day 1|The amount of recFSH administered for a participant to reach 3 follicles >= 17 mm, starting from treatment Day 1 onwards.|From Day 1 to day of hCG treatment (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants with hCG injection.||IU||Full Range|Median
767583|NCT00696800|Primary|Mean Number of Oocytes Retrieved|Up to 36 hours after receiving hCG, cumulus-oocyte-complexes were retrieved. Mean numbers retrieved were calculated per attempt, meaning that if a participant did not reach this stage in In Vitro Fertilization (IVF) treatment, zero values were imputed.|Up to 36 hours after administration of hCG (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to.||Number of oocytes||Standard Deviation|Mean
767584|NCT00696800|Primary|Percentage of Participants With an Ongoing Pregnancy (Ongoing Pregnancy Rate)|An ongoing pregnancy is a fetus with heart activity at least 10 weeks after embryo transfer as assessed by Ultrasound Scan (USS) or Doppler or is confirmed by live birth. The ongoing pregnancy rate is 100 times the number of participants with an ongoing pregnancy after embryo transfer, divided by the total number of participants who started treatment. Calculations were made per attempt, meaning that participants who did not have embryo transfers were considered not pregnant.|Assessed at least 10 weeks after embryo transfer (up to 1 year)|Intent to Treat (ITT) population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to.||Percentage of participants|||Number
767585|NCT00696878|Secondary|Serum Inhibin-B Levels in Treatment Cycle 3|Blood samples for assessment of serum inhibin-B were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.|Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 3|Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 3||pg/mL||Standard Deviation|Mean
767586|NCT00696878|Secondary|Serum Inhibin-B Levels in Treatment Cycle 2|Blood samples for assessment of serum inhibin-B were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.|Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 2|Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 2||pg/mL||Standard Deviation|Mean
767587|NCT00696878|Secondary|Serum Inhibin-B Levels in Treatment Cycle 1|Blood samples for assessment of serum inhibin-B were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.|Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 1|Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 1||pg/mL||Standard Deviation|Mean
767588|NCT00696878|Secondary|Serum Progesterone Levels in Treatment Cycle 3|Blood samples for assessment of serum progesterone were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.|Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 3|Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 3||nmol/L||Standard Deviation|Mean
767589|NCT00696878|Secondary|Serum Progesterone Levels in Treatment Cycle 2|Blood samples for assessment of serum progesterone were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.|Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 2|Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 2||nmol/L||Standard Deviation|Mean
767590|NCT00696878|Secondary|Serum Progesterone Levels in Treatment Cycle 1|Blood samples for assessment of serum progesterone were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.|Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 1|Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 1||nmol/L||Standard Deviation|Mean
767591|NCT00696878|Secondary|Serum Estradiol Levels in Treatment Cycle 3|Blood samples for assessment of serum estradiol were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.|Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 3|Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 3||pmol/L||Standard Deviation|Mean
767592|NCT00696878|Secondary|Serum Estradiol Levels in Treatment Cycle 2|Blood samples for assessment of serum estradiol were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.|Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 2|Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 2||pmol/L||Standard Deviation|Mean
767593|NCT00696878|Secondary|Serum Estradiol Levels in Treatment Cycle 1|Blood samples for assessment of serum estradiol were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.|Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 1|Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 1||pmol/L||Standard Deviation|Mean
767594|NCT00696878|Secondary|Serum LH Levels in Treatment Cycle 3|Blood samples for assessment of serum LH were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.|Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 3|Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 3||IU/L||Standard Deviation|Mean
767595|NCT00696878|Secondary|Serum LH Levels in Treatment Cycle 2|Blood samples for assessment of serum LH were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.|Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 2|Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 2||IU/L||Standard Deviation|Mean
767596|NCT00696878|Secondary|Serum Luteinizing Hormone (LH) Levels in Treatment Cycle 1|Blood samples for assessment of serum LH were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.|Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 1|Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 1||IU/L||Standard Deviation|Mean
767597|NCT00696878|Secondary|Serum FSH Levels in Treatment Cycle 3|Blood samples for assessment of serum FSH were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.|Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 3|Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 3||IU/L||Standard Deviation|Mean
767598|NCT00696878|Secondary|Serum FSH Levels in Treatment Cycle 2|Blood samples for assessment of serum FSH were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.|Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 2|Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 2||IU/L||Standard Deviation|Mean
767687|NCT00697190|Primary|Assessment of Limbal Hyperemia in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)|Limbal hyperemia measures the redness around the edge of the cornea. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.|after 6 hours of wear|There were 13 subjects that were oblique astigmats within the total completed population of 38.||Units on a scale||Standard Error|Least Squares Mean
767599|NCT00696878|Secondary|Serum Follicle Stimulating Hormone (FSH) Levels in Treatment Cycle 1|Blood samples for assessment of serum FSH were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.|Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 1|Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 1||International Units (IU)/L||Standard Deviation|Mean
767600|NCT00696878|Secondary|Cumulative Ongoing Pregnancy Rate: Percentage of Participants With Ongoing Pregnancy in Treatment Cycles 1, 2 or 3, or in Any FTET Cycle, or Who Had Ongoing Pregnancy That Was a Spontaneous Pregnancy|The ongoing pregnancy rate, cumulative over the entire study (in percent), is defined as 100 times the number of participants who had an ongoing pregnancy in Treatment Cycles 1, 2 or 3, or in any FTET cycle, or who had a spontaneous ongoing pregnancy, divided by the total number of participants who were administered corifollitropin alfa in the study. A participant could only be represented once in the count of ongoing pregnancies for determination of cumulative ongoing pregnancy rate. After the first and after the second treatment cycle (i.e., a cycle in which corifollitropin alfa was administered for ovarian stimulation), participants could continue with a maximum of three FTET cycles before starting the following treatment cycle. A spontaneous pregnancy is a pregnancy that was not considered to have resulted from ET in a treatment cycle or FTET cycle.|Up to approximately 26 months after first dose of corifollitropin alfa|Participants who received corifollitropin alfa||percentage of participants|||Number
767601|NCT00696878|Secondary|Number of Participants With Ongoing Pregnancy in Any FTET Cycle|After the first and after the second treatment cycle (i.e., a cycle in which corifollitropin alfa was administered for ovarian stimulation), participants could continue with a maximum of three FTET cycles before starting the following treatment cycle. This measure summarizes the number of participants with ongoing pregnancy following ET within an FTET cycle. Ongoing pregnancy: Presence of at least one fetus with heart activity as assessed by ultrasound scan at least 10 weeks after ET, or confirmed by live birth.|10 weeks up to 9 months after ET within an FTET cycle|Participants who received corifollitropin alfa and had ET in any FTET cycle||participants|||Number
767602|NCT00696878|Secondary|Number of Participants With Ectopic Pregnancy Among Participants With Biochemical Pregnancy in Any of Treatment Cycles 1, 2 or 3|Ectopic pregnancy: A pregnancy in which the embryo attaches itself in a place other than inside the uterus. The most common site for an ectopic pregnancy is within one of the two fallopian tubes. Biochemical pregnancy: Pregnancy proven by a biochemical pregnancy test using urine samples or serum samples collected at least 14 days after ET. Participants not having a positive biochemical pregnancy test result, but with an ultrasound scan showing at least one gestational sac were counted as having a biochemical pregnancy.|From 2 weeks up to approximately 5-6 weeks after ET, within a treatment cycle|Participants who received corifollitropin alfa and had biochemical pregnancy in any of Treatment Cycles 1, 2 or 3||participants|||Number
767603|NCT00696878|Secondary|Number of Participants With Miscarriage Among Participants With Vital Pregnancy in Any of Treatment Cycles 1, 2 or 3|Miscarriage: Loss of the fetus without induction or instrumentation, also known as “spontaneous abortion.” Vital pregnancy: Presence of at least one fetus with heart activity as assessed by ultrasound scan.|5-6 weeks up to 9 months after ET, within a treatment cycle|Participants who received corifollitropin alfa and had vital pregnancy in any of Treatment Cycles 1, 2 or 3||participants|||Number
767604|NCT00696878|Secondary|Number of Participants With Miscarriage Among Participants With Clinical Pregnancy in Any of Treatment Cycles 1, 2 or 3|Miscarriage: Loss of the fetus without induction or instrumentation, also known as “spontaneous abortion.” Clinical pregnancy: Presence of at least one gestational sac as assessed by ultrasound scan.|5-6 weeks up to 9 months after ET, within a treatment cycle|Participants who received corifollitropin alfa and had clinical pregnancy in any of Treatment Cycles 1, 2 or 3||participants|||Number
767605|NCT00696878|Secondary|Number of Participants With Singleton and Multiple Ongoing Pregnancy in Any of Treatment Cycles 1, 2 or 3|Singleton pregnancy is a pregnancy in which one fetus develops in the uterus. Multiple pregnancy is a pregnancy in which more than one fetus develops simultaneously in the uterus. Ongoing pregnancy: Presence of at least one fetus with heart activity as assessed by ultrasound scan at least 10 weeks after ET, or confirmed by live birth.|10 weeks up to 9 months after ET, within a treatment cycle|Participants who received corifollitropin alfa and had ongoing pregnancy in any of Treatment Cycles 1, 2 or 3||participants|||Number
767606|NCT00696878|Secondary|Number of Participants With Biochemical Pregnancy, Clinical Pregnancy, Vital Pregnancy and Ongoing Pregnancy in Any of Treatment Cycles 1, 2 or 3|Biochemical pregnancy: Pregnancy proven by a biochemical pregnancy test using urine samples or serum samples collected at least 14 days after ET. Participants not having a positive biochemical pregnancy test result, but with an ultrasound scan showing at least one gestational sac were counted as having a biochemical pregnancy. Clinical pregnancy: Presence of at least one gestational sac as assessed by ultrasound scan. Vital pregnancy: Presence of at least one fetus with heart activity as assessed by ultrasound scan. Ongoing pregnancy: Presence of at least one fetus with heart activity as assessed by ultrasound scan at least 10 weeks after ET, or confirmed by live birth.|≥14 days (for biochemical pregnancy), 5-6 weeks (for clinical pregnancy), 5-6 weeks to 10 weeks (for vital pregnancy) and 10 weeks up to 9 months (for ongoing pregnancy) after ET, within a treatment cycle|Participants who received corifollitropin alfa||participants|||Number
767607|NCT00696878|Secondary|Implantation Rate for Participants With ET|The implantation rate (in percent) is defined as 100 times the maximum number of gestational sacs as assessed by any ultrasound scan after ET divided by the number of embryos transferred per participant.|Approximately 5-6 weeks after ET, within a treatment cycle|Participants who received corifollitropin alfa and had ET||percentage of embryos||Standard Deviation|Mean
767608|NCT00696878|Secondary|Number and Quality of Embryos Obtained That Were Frozen in Treatment Cycle 3|The number of embryos that were cryopreserved (frozen) for possible later use, for each participant, overall and by embryo quality categories, is summarized. Quality was rated as Grade 1, 2 or 3, or “other grade”, with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of “good quality.”|Day 3 or Day 5 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 3|Participants who received corifollitropin alfa in Treatment Cycle 3||number of embryos||Standard Deviation|Mean
767701|NCT00697515|Secondary|Change From Baseline in Diastolic Blood Pressure at Up to 28 Days in the Dose Optimization Phase||Baseline and 7, 14, 21 and 28 days|SP||mmHg||Standard Deviation|Mean
767609|NCT00696878|Secondary|Number and Quality of Embryos Obtained That Were Frozen in Treatment Cycle 2|The number of embryos that were cryopreserved (frozen) for possible later use, for each participant, overall and by embryo quality categories, is summarized. Quality was rated as Grade 1, 2 or 3, or “other grade”, with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of “good quality.”|Day 3 or Day 5 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 2|Participants who received corifollitropin alfa in Treatment Cycle 2||number of embryos||Standard Deviation|Mean
767610|NCT00696878|Secondary|Number and Quality of Embryos Obtained That Were Frozen in Treatment Cycle 1|The number of embryos that were cryopreserved (frozen) for possible later use, for each participant, overall and by embryo quality categories, is summarized. Quality was rated as Grade 1, 2 or 3, or “other grade”, with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of “good quality.”|Day 3 or Day 5 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 1|Participants who received corifollitropin alfa in Treatment Cycle 1||number of embryos||Standard Deviation|Mean
767611|NCT00696878|Secondary|Number of Participants by Category of Number of Good Quality Embryos Transferred in Treatment Cycle 3|The number of embryos transferred, for each participant, by category of number of “good quality” embryos transferred, is summarized. Quality was rated as Grade 1, 2 or 3, or “other grade”, with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of “good quality.”|At ET, Day 3 or Day 5 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 3|Participants who received corifollitropin alfa and had ET in Treatment Cycle 3||participants|||Number
767612|NCT00696878|Secondary|Number of Participants by Category of Number of Good Quality Embryos Transferred in Treatment Cycle 2|The number of embryos transferred, for each participant, by category of number of “good quality” embryos transferred, is summarized. Quality was rated as Grade 1, 2 or 3, or “other grade”, with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of “good quality.”|At ET, Day 3 or Day 5 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 2|Participants who received corifollitropin alfa and had ET in Treatment Cycle 2||participants|||Number
767613|NCT00696878|Secondary|Number of Participants by Category of Number of Good Quality Embryos Transferred in Treatment Cycle 1|The number of embryos transferred, for each participant, by category of number of “good quality” embryos transferred, is summarized. Quality was rated as Grade 1, 2 or 3, or “other grade”, with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of “good quality.”|At ET, Day 3 or Day 5 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 1|Participants who received corifollitropin alfa and had ET in Treatment Cycle 1||participants|||Number
767614|NCT00696878|Secondary|Number of Embryos Transferred|ET is the procedure in which one or more embryos are placed in the uterus. The number of embryos transferred, per participant, is summarized.|At ET, Day 3 or Day 5 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), within a treatment cycle|Participants who received corifollitropin alfa and had ET||number of embryos||Standard Deviation|Mean
767615|NCT00696878|Secondary|Number and Quality of Embryos Obtained at Day 3 After Oocyte Pick-up in Treatment Cycle 3|At Day 3 after oocyte pick-up, embryos obtained from IVF or ISCI process for each participant were counted and quality was assessed. Quality was rated as Grade 1, 2 or 3, or “other grade”, with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of “good quality.”|Day 3 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 3|Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 3 and had embryo assessment at Day 3 after oocyte pick-up; excludes participants with embryo transfer or embryos cryopreserved before Day 3||number of embryos||Standard Deviation|Mean
767616|NCT00696878|Secondary|Number and Quality of Embryos Obtained at Day 3 After Oocyte Pick-up in Treatment Cycle 2|At Day 3 after oocyte pick-up, embryos obtained from IVF or ISCI process for each participant were counted and quality was assessed. Quality was rated as Grade 1, 2 or 3, or “other grade”, with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of “good quality.”|Day 3 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 2|Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 2 and had embryo assessment at Day 3 after oocyte pick-up; excludes participants with embryo transfer or embryos cryopreserved before Day 3||number of embryos||Standard Deviation|Mean
767617|NCT00696878|Secondary|Number and Quality of Embryos Obtained at Day 3 After Oocyte Pick-up in Treatment Cycle 1|At Day 3 after oocyte pick-up, embryos obtained from IVF or ISCI process for each participant were counted and quality was assessed. Quality was rated as Grade 1, 2 or 3, or “other grade”, with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of “good quality.”|Day 3 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 1|Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 1 and had embryo assessment at Day 3 after oocyte pick-up; excludes participants with embryo transfer or embryos cryopreserved before Day 3||number of embryos||Standard Deviation|Mean
767618|NCT00696878|Secondary|Fertilization Rate|The fertilization rate (in percent) is defined as 100 times the ratio of the number of fertilized 2 PN oocytes obtained and the number of oocytes that was used for fertilization, per participant.|16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), within a treatment cycle|Participants who received corifollitropin alfa and had IVF and/or ICSI||percentage of oocytes||Standard Deviation|Mean
767686|NCT00697190|Primary|Assessment of Corneal Staining in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)|Corneal staining measures changes to the surface of the cornea, as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.|after 6 hours of wear|There were 11 subjects that were high myopes within the total completed population of 38.||Units on a scale||Standard Error|Least Squares Mean
767619|NCT00696878|Secondary|Number of Fertilized Oocytes Obtained That Were Used for Embryo Development in Treatment Cycle 3|This measure presents the number of fertilized oocytes obtained per participant from the IVF or ISCI procedure that were used for embryo development, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).|16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 3|Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 3||number of fertilized oocytes||Standard Deviation|Mean
767620|NCT00696878|Secondary|Number of Fertilized Oocytes Obtained That Were Used for Embryo Development in Treatment Cycle 2|This measure presents the number of fertilized oocytes obtained per participant from the IVF or ISCI procedure that were used for embryo development, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).|16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 2|Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 2||number of fertilized oocytes||Standard Deviation|Mean
767621|NCT00696878|Secondary|Number of Fertilized Oocytes Obtained That Were Used for Embryo Development in Treatment Cycle 1|This measure presents the number of fertilized oocytes obtained per participant from the IVF or ISCI procedure that were used for embryo development, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).|16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 1|Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 1||number of fertilized oocytes||Standard Deviation|Mean
767622|NCT00696878|Secondary|Number of Fertilized Oocytes Obtained That Were Frozen in Treatment Cycle 3|This measure presents the number of fertilized oocytes obtained per participant from the IVF or ICSI procedure that were cryopreserved (frozen) for possible later use, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).|16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 3|Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 3, and were enrolled at a site using cyropreservation at the fertilized oocyte level||number of fertilized oocytes||Standard Deviation|Mean
767623|NCT00696878|Secondary|Number of Fertilized Oocytes Obtained That Were Frozen in Treatment Cycle 2|This measure presents the number of fertilized oocytes obtained per participant from the IVF or ICSI procedure that were cryopreserved (frozen) for possible later use, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).|16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 2|Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 2, and were enrolled at a site using cyropreservation at the fertilized oocyte level||number of fertilized oocytes||Standard Deviation|Mean
767624|NCT00696878|Secondary|Number of Fertilized Oocytes Obtained That Were Frozen in Treatment Cycle 1|This measure presents the number of fertilized oocytes obtained per participant from the IVF or ICSI procedure that were cryopreserved (frozen) for possible later use, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).|16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 1|Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 1, and were enrolled at a site using cyropreservation at the fertilized oocyte level||number of fertilized oocytes||Standard Deviation|Mean
767625|NCT00696878|Secondary|Number of Fertilized Oocytes Obtained in Treatment Cycle 3|This measure presents the number of fertilized oocytes obtained per participant from the IVF or ISCI procedure, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).|16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 3|Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 3||number of fertilized oocytes||Standard Deviation|Mean
767626|NCT00696878|Secondary|Number of Fertilized Oocytes Obtained in Treatment Cycle 2|This measure presents the number of fertilized oocytes obtained per participant from the IVF or ISCI procedure, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).|16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 2|Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 2||number of fertilized oocytes||Standard Deviation|Mean
767627|NCT00696878|Secondary|Number of Fertilized Oocytes Obtained in Treatment Cycle 1|This measure presents the number of fertilized oocytes obtained per participant from the IVF or ISCI procedure, by category of number of pronuclei (PN) present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).|16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 1|Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 1||number of fertilized oocytes||Standard Deviation|Mean
767636|NCT00696878|Secondary|Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 8 During Treatment Cycle 2|For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.|Stimulation Day 8 in Treatment Cycle 2|Participants who received corifollitropin alfa and had data for assessment of follicles ≥11 mm on Stimulation Day 8 in Treatment Cycle 2||follicles||Standard Deviation|Mean
767628|NCT00696878|Secondary|Quality of Oocytes Assessed Prior to Planned ICSI in Treatment Cycle 3|This measure summarizes results of assessment of the quality of oocytes performed following oocyte retrieval, among participants scheduled for ICSI in Treatment Cycle 3. For oocytes obtained from each participant, the number in each of 3 stages of oocyte development were determined. The earliest phase is the germinal vesicles stage, during which the immature oocyte appears as a large vesicular nucleus. Metaphase I is an intermediate stage during which the vesicles have broken down and the polar body has not yet formed; the oocyte is still immature. Metaphase II is the mature oocyte and is indicated by the presence of the polar body. Rating of quality for usefulness in ICSI follows the order metaphase II (best quality), metaphase I (lesser quality) and germinal vesicles stage (poorest quality). Only metaphase II oocytes can be fertilized. Metaphase I oocytes can develop in vitro to metaphase II oocytes. Germinal vesicles stage oocytes are the least useful for ICSI procedures.|Day of oocyte pick-up, 34-36 hours after (rec)hCG administration (approximately Stimulation Day 10), in Treatment Cycle 3|Participants who received corifollitropin alfa and were to have ICSI in Treatment Cycle 3||number of oocytes||Standard Deviation|Mean
767629|NCT00696878|Secondary|Quality of Oocytes Assessed Prior to Planned ICSI in Treatment Cycle 2|This measure summarizes results of assessment of the quality of oocytes performed following oocyte retrieval, among participants scheduled for ICSI in Treatment Cycle 2. For oocytes obtained from each participant, the number in each of 3 stages of oocyte development were determined. The earliest phase is the germinal vesicles stage, during which the immature oocyte appears as a large vesicular nucleus. Metaphase I is an intermediate stage during which the vesicles have broken down and the polar body has not yet formed; the oocyte is still immature. Metaphase II is the mature oocyte and is indicated by the presence of the polar body. Rating of quality for usefulness in ICSI follows the order metaphase II (best quality), metaphase I (lesser quality) and germinal vesicles stage (poorest quality). Only metaphase II oocytes can be fertilized. Metaphase I oocytes can develop in vitro to metaphase II oocytes. Germinal vesicles stage oocytes are the least useful for ICSI procedures.|Day of oocyte pick-up, 34-36 hours after (rec)hCG administration (approximately Stimulation Day 10), in Treatment Cycle 2|Participants who received corifollitropin alfa and were to have ICSI in Treatment Cycle 2||number of oocytes||Standard Deviation|Mean
767630|NCT00696878|Secondary|Quality of Oocytes Assessed Prior to Planned ICSI in Treatment Cycle 1|This measure summarizes results of assessment of the quality of oocytes performed following oocyte retrieval, among participants scheduled for ICSI in Treatment Cycle 1. For oocytes obtained from each participant, the number in each of 3 stages of oocyte development were determined. The earliest phase is the germinal vesicles stage, during which the immature oocyte appears as a large vesicular nucleus. Metaphase I is an intermediate stage during which the vesicles have broken down and the polar body has not yet formed; the oocyte is still immature. Metaphase II is the mature oocyte and is indicated by the presence of the polar body. Rating of quality for usefulness in ICSI follows the order metaphase II (best quality), metaphase I (lesser quality) and germinal vesicles stage (poorest quality). Only metaphase II oocytes can be fertilized. Metaphase I oocytes can develop in vitro to metaphase II oocytes. Germinal vesicles stage oocytes are the least useful for ICSI procedures.|Day of oocyte pick-up, 34-36 hours after (rec)hCG administration (approximately Stimulation Day 10), in Treatment Cycle 1|Participants who received corifollitropin alfa and were to have ICSI in Treatment Cycle 1||number of oocytes||Standard Deviation|Mean
767631|NCT00696878|Secondary|Number of Oocytes Retrieved in a Participant Among Entire Study Population|Oocyte retrieval, also known as oocyte pick-up, is a technique used in in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI) in order to remove oocytes from the ovary of the female, enabling fertilization outside the body. The number of oocytes retrieved, per participant, is summarized.|Day of oocyte pick-up, 34-36 hours after (rec)hCG administration (approximately Stimulation Day 10), within a treatment cycle|Participants who received corifollitropin alfa||number of oocytes||Standard Deviation|Mean
767632|NCT00696878|Secondary|Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Day of (Rec)hCG Administration During Treatment Cycle 3|For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on the day of (rec)hCG administration during the treatment cycle was recorded.|Day of (rec)hCG administration (approximately Stimulation Day 10) in Treatment Cycle 3|Participants who received corifollitropin alfa and (rec)hCG, and had data for assessment of follicles ≥11 mm on day of (rec)hCG administration in Treatment Cycle 3||follicles||Standard Deviation|Mean
767633|NCT00696878|Secondary|Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Day of (Rec)hCG Administration During Treatment Cycle 2|For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on the day of (rec)hCG administration during the treatment cycle was recorded.|Day of (rec)hCG administration (approximately Stimulation Day 10) in Treatment Cycle 2|Participants who received corifollitropin alfa and (rec)hCG, and had data for assessment of follicles ≥11 mm on day of (rec)hCG administration in Treatment Cycle 2||follicles||Standard Deviation|Mean
767634|NCT00696878|Secondary|Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Day of (Rec)hCG Administration During Treatment Cycle 1|For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on the day of (rec)hCG administration during the treatment cycle was recorded.|Day of (rec)hCG administration (approximately Stimulation Day 10) in Treatment Cycle 1|Participants who received corifollitropin alfa and (rec)hCG, and had data for assessment of follicles ≥11 mm on day of (rec)hCG administration in Treatment Cycle 1||follicles||Standard Deviation|Mean
767635|NCT00696878|Secondary|Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 8 During Treatment Cycle 3|For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.|Stimulation Day 8 in Treatment Cycle 3|Participants who received corifollitropin alfa and had data for assessment of follicles ≥11 mm on Stimulation Day 8 in Treatment Cycle 3||follicles||Standard Deviation|Mean
767660|NCT00697112|Secondary|Percentage of Participants With Adverse Events|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug.|Baseline up to Month 12|Safety population included all participants who had received at least 1 dose of Rapamune and were subsequently interrogated.||percentage of participants|||Number
767637|NCT00696878|Secondary|Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 8 During Treatment Cycle 1|For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.|Stimulation Day 8 in Treatment Cycle 1|Participants who received corifollitropin alfa and had data for assessment of follicles ≥11 mm on Stimulation Day 8 in Treatment Cycle 1||follicles||Standard Deviation|Mean
767638|NCT00696878|Secondary|Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 5 or 6 During Treatment Cycle 3|For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.|Stimulation Day 5 or 6 in Treatment Cycle 3|Participants who received corifollitropin alfa and had data for assessment of follicles ≥11 mm on Stimulation Day 5 or 6 in Treatment Cycle 3||follicles||Standard Deviation|Mean
767639|NCT00696878|Secondary|Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 5 or 6 During Treatment Cycle 2|For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.|Stimulation Day 5 or 6 in Treatment Cycle 2|Participants who received corifollitropin alfa and had data for assessment of follicles ≥11 mm on Stimulation Day 5 or 6 in Treatment Cycle 2||follicles||Standard Deviation|Mean
767640|NCT00696878|Secondary|Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 5 or 6 During Treatment Cycle 1|For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.|Stimulation Day 5 or 6 in Treatment Cycle 1|Participants who received corifollitropin alfa and had data for assessment of follicles ≥11 mm on Stimulation Day 5 or 6 in Treatment Cycle 1||follicles||Standard Deviation|Mean
767641|NCT00696878|Secondary|Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 1 During Treatment Cycle 3|For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.|Stimulation Day 1 in Treatment Cycle 3|Participants who received corifollitropin alfa and had data for assessment of follicles ≥11 mm on Stimulation Day 1 in Treatment Cycle 3||follicles||Standard Deviation|Mean
767642|NCT00696878|Secondary|Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 1 During Treatment Cycle 2|For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.|Stimulation Day 1 in Treatment Cycle 2|Participants who received corifollitropin alfa and had data for assessment of follicles ≥11 mm on Stimulation Day 1 in Treatment Cycle 2||follicles||Standard Deviation|Mean
767643|NCT00696878|Secondary|Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 1 During Treatment Cycle 1|For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.|Stimulation Day 1 in Treatment Cycle 1|Participants who received corifollitropin alfa and had data for assessment of follicles ≥11 mm on Stimulation Day 1 in Treatment Cycle 1||follicles||Standard Deviation|Mean
767644|NCT00696878|Secondary|Amount of (Rec)FSH Needed From Stimulation Day 8 Onwards to Reach the Criterion for Administration of (Rec)hCG|Beginning on Stimulation Day 8 of each treatment cycle, (rec)FSH was administered daily until the criteria for administration of (rec)hCG (presence of 3 follicles ≥17 mm documented by ultrasonography) was reached. The total amount of (rec)FSH administered in each participant to reach the criteria for (rec)hCG administration was calculated.|Stimulation Day 8 to day of (rec)hCG administration (approximately Stimulation Day 10), within a treatment cycle|Participants who received corifollitropin alfa and (rec)hCG||International Unit (IU)||Full Range|Median
767645|NCT00696878|Primary|Number of Participants With Moderate to Severe Ovarian Hyperstimulation Syndrome (OHSS)|OHSS was classified on study based on a slightly modified WHO Scientific Group (1973) classification: Grade I (mild) = characterized by excessive steroid secretion and ovarian enlargement (5-7 cm). Abdominal discomfort, including abdominal pain, is present. Grade II (moderate) = characterized by distinct ovarian cysts (ovary size 8-10 cm), accompanied by abdominal pain and tension, nausea, vomiting, diarrhea. Grade III (severe) = characterized by enlarged cystic ovaries (ovary size >10 cm), accompanied by ascites and occasionally hydrothorax. Abdominal tension and pain may be severe. Pronounced hydrothorax together with an abdominal cavity filled with cysts and fluid elevating the diaphragm may cause severe breathing difficulties. Large quantities of fluid inside the cysts and in the peritoneal and pleural cavities cause haemoconcentration and increased blood viscosity. In rare cases, the syndrome may further be complicated by the occurrence of thromboembolic phenomena.|Up to approximately 1 month after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), within a treatment cycle|Participants who received corifollitropin alfa||participants|||Number
767646|NCT00696878|Primary|Number of Participants With Serious AEs (SAEs)|An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect. SAEs that occurred in fetuses or infants during the study period are included in this summary of SAEs, and are allocated to the associated study participant who was administered corifollitropin alfa.|Up to approximately 26 months after first dose of corifollitropin alfa|Participants who received corifollitropin alfa||participants|||Number
767647|NCT00696878|Primary|Number of Participants With AEs|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|Up to approximately 26 months after first dose of corifollitropin alfa|Participants who received corifollitropin alfa||participants|||Number
767702|NCT00697515|Secondary|Change From Baseline in Systolic Blood Pressure at Up to 28 Days in the Dose Optimization Phase||Baseline and 7, 14, 21 and 28 days|Safety Population (SP) defined as all subjects who received at least one dose of study medication.||mmHg||Standard Deviation|Mean
767648|NCT00696878|Primary|Local Tolerance at Injection Site Overall Summary: Number of Participants With no Local Tolerance Event (Itching, Pain, Redness or Swelling) and With a Mild, Moderate and Severe Local Tolerance Event in Any of 3 Treatment Cycles|At 30 minutes after dosing in each treatment cycle, the corifollitropin alfa injection site was assessed for the presence of itching, pain, redness and swelling, each of which was scored as none (no event), mild, moderate or severe. This measure reports results considering the occurrence of any of the defined local tolerance events. A participant with an event was counted once in this analysis.|30 minutes post dose in each treatment cycle|Participants who received corifollitropin alfa||participants|||Number
767649|NCT00696878|Primary|Local Tolerance at Injection Site: Number of Participants With no Event of Swelling and With Mild, Moderate and Severe Swelling in Any of 3 Treatment Cycles|At 30 minutes after dosing in each treatment cycle, the corifollitropin alfa injection site was assessed for the presence of itching, pain, redness and swelling, each of which was scored as none (no event), mild, moderate or severe. This measure reports results for the assessment of swelling. A participant with an event was counted once in this analysis.|30 minutes post dose in each treatment cycle|Participants who received corifollitropin alfa||participants|||Number
767650|NCT00696878|Primary|Local Tolerance at Injection Site: Number of Participants With no Event of Redness and With Mild, Moderate and Severe Redness in Any of 3 Treatment Cycles|At 30 minutes after dosing in each treatment cycle, the corifollitropin alfa injection site was assessed for the presence of itching, pain, redness and swelling, each of which was scored as none (no event), mild, moderate or severe. This measure reports results for the assessment of redness. A participant with an event was counted once in this analysis.|30 minutes post dose in each treatment cycle|Participants who received corifollitropin alfa||participants|||Number
767651|NCT00696878|Primary|Local Tolerance at Injection Site: Number of Participants With no Event of Pain and With Mild, Moderate and Severe Pain in Any of 3 Treatment Cycles|At 30 minutes after dosing in each treatment cycle, the corifollitropin alfa injection site was assessed for the presence of itching, pain, redness and swelling, each of which was scored as none (no event), mild, moderate or severe. This measure reports results for the assessment of pain. A participant with an event was counted once in this analysis.|30 minutes post dose in each treatment cycle|Participants who received corifollitropin alfa||participants|||Number
767652|NCT00696878|Primary|Local Tolerance at Injection Site: Number of Participants With no Event of Itching and With Mild, Moderate and Severe Itching in Any of 3 Treatment Cycles|At 30 minutes after dosing in each treatment cycle, the corifollitropin alfa injection site was assessed for the presence of itching, pain, redness and swelling, each of which was scored as none (no event), mild, moderate or severe. This measure reports results for the assessment of itching. A participant with an event was counted once in this analysis.|30 minutes post dose in each treatment cycle|Participants who received corifollitropin alfa||participants|||Number
767653|NCT00696878|Primary|Percentage of Participants With Clinically Relevant Immunogenicity|Serum samples obtained pre-dose and at 2 weeks after embryo transfer (ET), or at cycle discontinuation and 2-3 weeks after cycle discontinuation if cycle was stopped before ET was performed, were analyzed for presence of anti-corifollitropin alfa antibodies using screening and confirmatory tests. If a participant was confirmed to have anti-corifollitropin alfa antibody present in a post dose sample according to these tests, review of adverse events (AEs) in the participant was performed. The sample was also tested to evaluate whether the antibody appeared to have neutralizing activity that would interfere with the study drug biological effect. A participant was determined to have clinically relevant immunogenicity if the participant had a confirmed post dose anti-corifollitropin alfa antibody test result accompanied by clinical signs of immunogenicity (e.g., hypersensitivity reaction), considering also the results of the test for neutralizing activity of any antibody present.|Pre-dose (Stimulation Day 1) and up to approximately 40 days post dose in each treatment cycle|Participants who received corifollitropin alfa and had a post dose sample for anti-corifollitropin alfa antibody testing||percentage of participants|||Number
767654|NCT00697073|Secondary|Nature and Frequency of Adverse Events||12 Months||||||
767655|NCT00697073|Secondary|FARS (Friedreich’s Ataxia Rating Scale)||baseline and 12 Months||||||
767656|NCT00697073|Primary|Change in ICARS|"International Cooperative Ataxia Rating Scale (ICARS):
ICARS consists of a one-hundred-point semi-quantitative scale based upon 19 simple testing manoeuvres compartmentalized into postural and stance disorders, limb ataxia, dysarthria and oculomotor disorders and has been previously used in this patient population with good inter-rater reliability.
Scores for each subscale quantify the extent of ataxia in each clinically important area. Subscale scores are summed to give a total score ranging from 0 (best) to 100 (worst)."|baseline and 12 months|||ICARS points||Standard Deviation|Mean
767657|NCT00697112|Secondary|Percentage of Participants With Clinically-Significant Radiological Abnormalities|Radiological examination was performed to evaluate presence or signs of infections or pneumonitis.|Baseline up to Month 12|Safety population included all participants who had received at least 1 dose of Rapamune and were subsequently interrogated.||percentage of participants|||Number
767658|NCT00697112|Secondary|Percentage of Participants With Clinically-Significant Electrocardiogram Abnormalities|Standard 12-lead ECG was performed. ECG intervals included PR interval (time between the onset of atrial depolarization and the onset of ventricular depolarization), QRS interval (represented ventricular depolarization), QT interval (time corresponding to the beginning of depolarization to repolarization of the ventricles) corrected using Fridericia's formula (QTcF = QT divided by cube root of RR interval) and heart rate (time interval between consecutive heart beats [RR interval]).|Baseline up to Month 12|Safety population included all participants who had received at least 1 dose of Rapamune and were subsequently interrogated.||percentage of participants|||Number
767659|NCT00697112|Secondary|Percentage of Participants With Serious Adverse Events|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to Month 12|Safety population included all participants who had received at least 1 dose of Rapamune and were subsequently interrogated.||percentage of participants|||Number
767729|NCT00697593|Primary|Biochemistry - Glutamyl Transferase|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 1 participant missing values||IU/L||Standard Deviation|Mean
767661|NCT00697112|Secondary|Percentage of Participants With Physical Abnormalities|Physical abnormalities included all the abnormalities related to general disorders and administration site conditions, gastrointestinal disorders, skin and subcutaneous tissue disorders, vascular disorders, investigations, infections and infestations, eye disorders, respiratory, thoracic and mediastinal disorders, nervous system disorders, musculoskeletal and connective tissue disorders, injury, poisoning and procedural complications, surgical and medical procedures, psychiatric disorders, neoplasms benign, malignant and unspecified (incl cysts and polyps), ear and labyrinth disorders, and congenital, familial and genetic disorders.|Baseline up to Month 12|Safety population included all participants who had received at least 1 dose of Rapamune and were subsequently interrogated.||percentage of participants|||Number
767662|NCT00697112|Secondary|Body Weight||Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53|Safety population included all participants who had received at least 1 dose of Rapamune and were subsequently interrogated. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points.||kilogram||Standard Deviation|Mean
767663|NCT00697112|Secondary|Pulse Rate||Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53|Safety population included all participants who had received at least 1 dose of Rapamune and were subsequently interrogated. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points.||beats per minute||Standard Deviation|Mean
767664|NCT00697112|Secondary|Blood Pressure|Systolic and diastolic blood pressure (BP) was measured after the participant had rested in the supine position for at least 5 minutes with the participant’s arm supported at the level of the heart, and recorded to the nearest millimeters of mercury (mmHg).|Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53|Safety population included all participants who had received at least 1 dose of Rapamune and were subsequently interrogated. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points.||mmHg||Standard Deviation|Mean
767665|NCT00697112|Secondary|Number of Participants With Body Temperature|Body temperature was measured in degree Celsius. Each participants were classified into three different categories based on their body temperature: body temperature less than 35 degree Celsius = hypothermia, body temperature between 35 to 37.5 degree Celsius = feverless, and body temperature greater than 37.5 degree Celsius = fever.|Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53|Safety population. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points. Results for hypothermia not reported as none of the participants was found hypothermic.||participants|||Number
767666|NCT00697112|Secondary|Body Mass Index|BMI was calculated as weight divided by height squared and measured as kilogram per square meter (kg/m^2).|Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53|Safety population included all participants who had received at least 1 dose of Rapamune and were subsequently interrogated. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points.||kg/m^2||Standard Deviation|Mean
767667|NCT00697112|Secondary|Percentage of Participants Who Prematurely Discontinued the Sirolimus (Rapamune) Therapy Due to Adverse Events|An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Participants who discontinued sirolimus (Rapamune) therapy prematurely due to AE were obliged to discontinue sirolimus (Rapamune) therapy permanently, are reported.|Baseline up to Month 12|ITT population included all participants who were treated with Rapamune for at least 4 or 5 weeks.||percentage of participants|||Number
767668|NCT00697112|Secondary|Percentage of Participants Who Prematurely Discontinued the Sirolimus (Rapamune) Therapy Due to Inefficacy||Baseline up to Month 12|ITT population included all participants who were treated with Rapamune for at least 4 or 5 weeks.||percentage of participants|||Number
767669|NCT00697112|Secondary|Percentage of Participants Who Prematurely Discontinued the Sirolimus (Rapamune) Therapy||Baseline up to Month 12|ITT population included all participants who were treated with Rapamune for at least 4 or 5 weeks.||percentage of participants|||Number
767670|NCT00697112|Secondary|Average Proteinuria|Proteinuria defined as the presence of an excess of serum proteins in the urine. Normal value of proteinuria is below 0.15 grams per 24 hours (g/24 hr).|Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53|ITT population included all participants who were treated with Rapamune for at least 4 or 5 weeks. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points.||g/24 hr||Standard Deviation|Mean
767671|NCT00697112|Secondary|Average Creatinine Clearance|Creatinine clearance (CCr) is a measure of glomerular filtration rate (GMFR), an index of kidney function. CCr is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 milliliter per minute (mL/min) and for females, 90-125 mL/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.|Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53|ITT population included all participants who were treated with Rapamune for at least 4 or 5 weeks. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points.||milliliter per minute (mL/min)||Standard Deviation|Mean
767672|NCT00697112|Secondary|Average Blood Level of Immunosuppressive Drugs Administered|Immunosuppressive drugs administered included cyclosporin A (CsA) administration based on monitoring of plasma trough levels (C0), CsA administration based on monitoring of plasma levels 2-hours after CsA dose (C2), tacrolimus, and sirolimus (Rapamune).|Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53|ITT population. N(number of participants analyzed)=participants evaluable for this measure. n=participants evaluable at given time point for specified immunosuppressive. Results not reported for CsA C0 at Week 1/2, 12/13, 24/25; CsA C2 at Week 1/2, 4/5, 12/13, 24/25, 52/53; sirolimus at baseline as no participants evaluable at those time points.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
767673|NCT00697112|Secondary|Average Dose of Immunosuppressive Drugs Administered|Immunosuppressive drugs administered included cyclosporin A (CsA) administration based on monitoring of plasma trough levels (C0), CsA administration based on monitoring of plasma levels 2-hours after CsA dose (C2), tacrolimus, and sirolimus (Rapamune).|Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53|ITT population. N(number of participants analyzed)=participants evaluable for this measure. n=participants evaluable at given time point for specified immunosuppressive. Results not reported for CsA C0 at Week 1/2, 12/13, 24/25; CsA C2 at Week 1/2, 4/5, 12/13, 24/25, 52/53; sirolimus at baseline as no participants evaluable at those time points.||milligram per day||Standard Deviation|Mean
767674|NCT00697112|Secondary|Probability of Participant Survival|Participant's survival defined as participant living with or without a functioning graft. Probability of participant survival throughout the sirolimus (Rapamune) therapy was estimated using Kaplan-Meier method.|Month 12|ITT population included all participants who were treated with Rapamune for at least 4 or 5 weeks.||probability of participant survival||95% Confidence Interval|Number
767675|NCT00697112|Secondary|Probability of no Acute Rejection|Diagnosis of acute rejection was made via kidney biopsy. Categorization of biopsies with suspected acute rejection was based on histological findings using updated 1997 Banff criteria: Grade 1A: significant interstitial infiltration (greater than [>] 25 percent [%] of parenchyma affected) and foci of moderate tubulitis (5-10 cells/tubular cross section), Grade 1B: significant interstitial infiltration (>25% of parenchyma affected) and severe tubulitis (>10 mononuclear cells/tubular cross section), Grade 2A: mild-moderate intimal arteritis, Grade 2B: severe intimal arteritis comprising >25% of the luminal area and Grade 3: transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells. Probability of no acute rejection throughout the sirolimus (Rapamune) therapy was estimated using Kaplan-Meier method.|Month 12|ITT population included all participants who were treated with Rapamune for at least 4 or 5 weeks.||probability of no acute rejection||95% Confidence Interval|Number
767676|NCT00697112|Secondary|Probability of Graft Survival|Graft survival was considered in participants who did not experience graft failure. Graft failure was determined by return to dialysis for a period of at least 12 weeks with no return of function, or graft loss whichever occurred sooner.|Month 12|ITT population included all participants who were treated with Rapamune for at least 4 or 5 weeks.||probability of graft survival||95% Confidence Interval|Number
767677|NCT00697112|Primary|Percentage of Participants With Main Reason for the Use of Sirolimus (Rapamune) Therapy|The study employ a questionnaire which included different clinical criteria to determine the main medical reason for the introduction of sirolimus (Rapamune) therapy after renal transplant. The physician responsible selected the one that was considered the main reason for introduction of sirolimus (Rapamune) as base immunosuppressive therapy.|Baseline|Intention-to-Treat (ITT) population included all participants who were treated with Rapamune for at least 4 or 5 weeks.||percentage of participants||95% Confidence Interval|Number
767678|NCT00697190|Primary|Assessment of Papillary Conjunctivitis in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)|Papillary conjunctivitis measures the changes to the conjunctival surface on the underside of the upper eyelid. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.|after 6 hours of wear|There were 13 subjects that were oblique astigmats within the total completed population of 38.||Units on a scale||Standard Error|Least Squares Mean
767679|NCT00697190|Primary|Assessment of Papillary Conjunctivitis in Subjects That Are Hyperopes (Farsighted)|Papillary conjunctivitis measures the changes to the conjunctival surface on the underside of the upper eyelid. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.|after 6 hours of wear|There were 14 subjects that were hyperopes within the total completed population of 38.||Units on a scale||Standard Error|Least Squares Mean
767680|NCT00697190|Primary|Assessment of Papillary Conjunctivitis in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)|Papillary conjunctivitis measures the changes to the conjunctival surface on the underside of the upper eyelid. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.|after 6 hours of wear|There were 11 subjects that were high myopes within the total completed population of 38.||Units on a scale||Standard Error|Least Squares Mean
767681|NCT00697190|Primary|Assessment of Conjunctival Staining in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)|Conjunctival staining measures the changes to the conjunctival surface as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.|after 6 hours of wear|There were 13 subjects that were oblique astigmats within the total completed population of 38.||Units on a scale||Standard Error|Least Squares Mean
767682|NCT00697190|Primary|Assessment of Conjunctival Staining in Subjects That Are Hyperopes (Farsighted)|Conjunctival staining measures the changes to the conjunctival surface as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.|after 6 hours of wear|There were 14 subjects that were hyperopes within the total completed population of 38.||Units on a scale||Standard Error|Least Squares Mean
767683|NCT00697190|Primary|Assessment of Conjunctival Staining in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)|Conjunctival staining measures the changes to the conjunctival surface as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.|after 6 hours of wear|There were 11 subjects that were high myopes within the total completed population of 38.||Units on a scale||Standard Error|Least Squares Mean
767684|NCT00697190|Primary|Assessment of Corneal Staining in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)|Corneal staining measures changes to the surface of the cornea, as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.|after 6 hours of wear|There were 13 subjects that were oblique astigmats within the total completed population of 38.||Units on a scale||Standard Error|Least Squares Mean
767685|NCT00697190|Primary|Assessment of Corneal Staining in Subjects That Are Hyperopes (Farsighted)|Corneal staining measures changes to the surface of the cornea, as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.|after 6 hours of wear|There were 14 subjects that were hyperopes within the total completed population of 38.||Units on a scale||Standard Error|Least Squares Mean
767730|NCT00697593|Primary|Biochemistry - Alkaline Phosphatase|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 1 participant missing values||IU/L||Standard Deviation|Mean
767688|NCT00697190|Primary|Assessment of Limbal Hyperemia in Subjects That Are Hyperopes (Farsighted)|Limbal hyperemia measures the redness around the edge of the cornea. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.|after 6 hours of wear|There were 14 subjects that were hyperopes within the total completed population of 38.||Units on a scale||Standard Error|Least Squares Mean
767689|NCT00697190|Primary|Assessment of Limbal Hyperemia in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)|Limbal hyperemia measures the redness around the edge of the cornea. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.|after 6 hours of wear|There were 11 subjects that were high myopes within the total completed population of 38.||Units on a scale||Standard Error|Least Squares Mean
767690|NCT00697190|Primary|Assessment of Conjunctival Hyperemia in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)|Conjunctival hyperemia measures the redness across the white of the eye. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.|after 6 hours of wear|There were 13 subjects that were oblique astigmats within the total completed population of 38.||Units on a scale||Standard Error|Least Squares Mean
767691|NCT00697190|Primary|Assessment of Conjunctival Hyperemia in Subjects That Are Hyperopes (Farsighted)|Conjunctival hyperemia measures the redness across the white of the eye. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.|after 6 hours of wear|There were 14 subjects that were hyperopes within the total completed population of 38.||Units on a scale||Standard Error|Least Squares Mean
767692|NCT00697190|Primary|Assessment of Conjunctival Hyperemia in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)|Conjunctival hyperemia measures the redness across the white of the eye. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.|after 6 hours of wear|There were 11 subjects that were high myopes within the total completed population of 38.||Units on a scale||Standard Error|Least Squares Mean
767693|NCT00697255|Secondary|Number of Participants With AEs of Ovarian Hyperstimulation Syndrome (OHSS)|OHSS was classified on study based on a slightly modified WHO Scientific Group (1973) classification: Grade I (mild) = characterized by excessive steroid secretion and ovarian enlargement (5-7 cm). Abdominal discomfort, including abdominal pain, is present. Grade II (moderate) = characterized by distinct ovarian cysts (ovary size 8-10 cm), accompanied by abdominal pain and tension, nausea, vomiting, diarrhea. Grade III (severe) = characterized by enlarged cystic ovaries (ovary size >10 cm), accompanied by ascites and occasionally hydrothorax. Abdominal tension and pain may be severe. Pronounced hydrothorax together with an abdominal cavity filled with cysts and fluid elevating the diaphragm may cause severe breathing difficulties. Large quantities of fluid inside the cysts and in the peritoneal and pleural cavities cause haemoconcentration and increased blood viscosity. In rare cases, the syndrome may further be complicated by the occurrence of thromboembolic phenomena.|During In-Treatment Period (up to 14 weeks after first corifollitropin injection)|The All-Participants-Treated (APT) group consisted of all participants who received corifollitropin alfa. Participants were grouped according to the stage of the trial and the active treatment group (recFSH Stage Ia, hCG Stage Ib) they actually received.||participants|||Number
767694|NCT00697255|Secondary|Number of Participants With Pregnancy|A pregnancy test (serum or urinary hCG) was performed two to three weeks after bolus injection of hCG. In case of a positive pregnancy test vaginal and/or abdominal ultrasound scan was performed to confirm the pregnancy at 5 to 6 weeks after bolus injection of hCG and ≥10 weeks after bolus injection of hCG to confirm ongoing pregnancy.|At least 10 weeks after bolus injection of hCG (up to 13 weeks)|Intent-to-Treat group (ITT) consisted of all treated participants (5 participants in Stage Ia and 3 participants in Stage Ib).||participants|||Number
767695|NCT00697255|Secondary|Percentage of Participants Who Cancelled Treatment (Cancellation Rate)|Treatment was considered cancelled if no bolus injection of hCG was administrated. Reasons of treatment failure included Adverse Event (AE)/ Serious Adverse Event (SAE), insufficient ovarian response on stimulation day 13 (no follicle ≥12 mm), insufficient ovarian response after 7 days of hCG/recFSH treatment (no follicle ≥18 mm), and multifollicular growth (≥3 follicles ≥15 mm).|Up to 3 weeks after bolus injection of hCG (up to 41 days)|Intent-to-Treat group (ITT) consisted of all treated participants (5 participants in Stage Ia and 3 participants in Stage Ib).||percentage of participants|||Number
767696|NCT00697255|Secondary|Percentage of Participants With Monofollicular Ovulation (Monofollicular Ovulation Rate)|Monofollicular ovulation rate was defined as the number of participants with monofollicular response (one follicle ≥18 mm and no other follicle ≥15 mm on the day of the bolus injection of hCG) and confirmed ovulation (≥15 nmol/l serum progesterone eight days after the bolus injection of hCG) divided by the number of treated participants. Ovulation was also considered confirmed for participants who became pregnant, had an ectopic pregnancy or had a miscarriage.|8 days after bolus injection of hCG (up to 28 days)|Intent-to-Treat group (ITT) consisted of all treated participants (5 participants in Stage Ia and 3 participants in Stage Ib).||percentage of participants|||Number
767697|NCT00697255|Secondary|Percentage of Participants With Ovulation (Ovulation Rate)|Ovulation rate was defined as the number of participants with confirmed ovulation (≥15 nmol/l serum progesterone eight days after the bolus injection of hCG) divided by the number of treated participants. Ovulation was also considered confirmed for participants who became pregnant, had an ectopic pregnancy or had a miscarriage.|8 days after bolus injection of hCG (up to 28 days)|Intent-to-Treat group (ITT) consisted of all treated participants (5 participants in Stage Ia and 3 participants in Stage Ib).||percentage of participants|||Number
767698|NCT00697255|Primary|Percentage of Participants With Monofollicular Response (Monofollicular Rate)|The monofollicular rate was defined as the number of participants with monofollicular response (one follicle ≥18 mm and no other follicle ≥15 mm on the day of the bolus injection of hCG) divided by the number of the treated participants.|At day of bolus injection of hCG (up to 20 days)|Intent-to-Treat group (ITT) consisted of all treated participants (5 participants in Stage Ia and 3 participants in Stage Ib).||percentage of participants|||Number
767699|NCT00697515|Secondary|Change From Baseline in Electrocardiogram Results (QTcF Interval) at 7 Days in the Crossover Phase|QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate(e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.|Baseline and 7 days|SP||msec||Standard Deviation|Mean
767700|NCT00697515|Secondary|Change From Baseline in Pulse Rate at Up to 28 Days in the Dose Optimization Phase||Baseline and 7, 14, 21 and 28 days|SP||bpm||Standard Deviation|Mean
767703|NCT00697515|Secondary|Change From Baseline in AIM-A Question 4 Score at 26 Days in the Dose Optimization Phase|AIM-A is a quality of life instrument. Question 4 is 'How much do you agree with this statement: Over the past few weeks, I've had more good days than bad days?' This is rated on a scale of 1 (strongly agree) to 5 (strongly disagree).|Baseline and 26 days|||Units on a scale||Standard Deviation|Mean
767704|NCT00697515|Secondary|Change From Baseline in Adult ADHD Impact Module (AIM-A) Question 1 Score at 26 Days in the Dose Optimization Phase|AIM-A is a quality of life instrument. Question 1 is 'On a scale of 1 to 10, how would you rate the overall quality of life right now?' It is rated on a scale of 1 (worst) to 10 (best).|Baseline and 26 days|EEP||Units on a scale||Standard Deviation|Mean
767705|NCT00697515|Secondary|Level of Satisfaction With Study Treatment on Medication Satisfaction Questionnaire (MSQ) in the Dose Optimization Phase|MSQ is a survey rating the subject's level of satisfaction with the study treatment medication.|26 days|EEP||Participants|||Number
767706|NCT00697515|Secondary|Change From Baseline in the Brown Attention Deficit Disorder Scale (BADDS) Total Scores at 26 Days in the Dose Optimization Phase|The BADDS assessment consists of 40 items rated on a scale from 0 (never) to 3 (almost daily). The total score ranges from 0 to 120 with increasing scores indicating more severe impairment.|Baseline and 26 days|EEP||Units on a scale||Standard Deviation|Mean
767707|NCT00697515|Secondary|Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) in the Crossover Phase|CGI-I consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|7 days|ITT||Participants|||Number
767708|NCT00697515|Secondary|Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) in the Dose Optimization Phase|CGI-I consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|7, 14, 21 and 28 days|EEP||Participants|||Number
767709|NCT00697515|Secondary|Assessment of Clinical Global Impression-Severity of Illness (CGI-S) in the Dose Optimization Phase|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|Baseline|EEP||Participants|||Number
767710|NCT00697515|Secondary|ADHD-RS With Prompts Total Score in the Crossover Phase|The Attention Deficit Hyperactivity Disorder Rating Scale with Prompts (ADHD-RS) consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|7 days|ITT||Units on a scale||Standard Error|Least Squares Mean
767711|NCT00697515|Secondary|Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale With Prompts (ADHD-RS) Total Score at up to 28 Days in the Dose Optimization Phase|The Attention Deficit Hyperactivity Disorder Rating Scale with Prompts (ADHD-RS) consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|Baseline and 7, 14, 21 and 28 days|Enrolled Efficacy Population (EEP) defined as all subjects who have taken one dose of study medication in the Dose Optimization Phase and had one post-Baseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
767712|NCT00697515|Secondary|PERMP Score for the Number of Math Problems Answered Correctly by Timepoint in the Crossover Phase|The Permanent Product Measure of Performance (PERMP) is a skill adjusted math test. The PERMP score is the sum of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session. The scores range from 0-800 with higher scores indicating better performance.|2, 4, 8, 10, 12 and 14 hours post-dose on Day 7|ITT||Units on a scale||Standard Error|Least Squares Mean
767713|NCT00697515|Secondary|PERMP Score for the Number of Math Problems Attempted by Timepoint in the Crossover Phase|The Permanent Product Measure of Performance (PERMP) is a skill adjusted math test. The PERMP score is the sum of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session. The scores range from 0-800 with higher scores indicating better performance.|2, 4, 8, 10, 12 and 14 hours post-dose on Day 7|ITT||Units on a scale||Standard Error|Least Squares Mean
767714|NCT00697515|Secondary|PERMP Total Score by Timepoint in the Crossover Phase|The Permanent Product Measure of Performance (PERMP) is a skill adjusted math test. The PERMP score is the sum of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session. The scores range from 0-800 with higher scores indicating better performance.|2, 4, 8, 10, 12 and 14 hours post-dose on Day 7|ITT||Units on a scale||Standard Error|Least Squares Mean
767715|NCT00697515|Primary|Permanent Product Measure of Performance (PERMP) Total Score Over the Treatment Day in the Crossover Phase|The Permanent Product Measure of Performance (PERMP) is a skill adjusted math test. The PERMP score is the sum of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session. The scores range from 0-800 with higher scores indicating better performance.|2, 4, 8, 10, 12 and 14 hours post-dose on Day 7|Intent to Treat (ITT) population defined as all subjects who are randomized and have at least one post-dose primary efficacy assessment.||Units on a scale||Standard Error|Least Squares Mean
767716|NCT00697541|Primary|Tmax - Time to Maximum Plasma Concentration|time to maximum plasma concentration|0 Hour (prior to dose) and at 1, 2, 3, 4, 5, 6, 7, and 8 hours post-morning dose|||Hours||Full Range|Mean
767717|NCT00697541|Primary|AUC - Area Under the Curve of Brimonidine|"Area under the plasma concentration-time curve from 0 hour to the last measurable plasma concentration, calculated by the linear trapezoidal method
After two topical applications of 0.18% COL-118 facial gel, plasma levels of brimonidine for all subjects were below the LoQ (25 pg/mL), with the exception of one single outlier value.
Thus, no PK analysis could be performed for 0.18% COL-118 facial gel.
After ocular administration of 0.2% brimonidine tartrate ophthalmic solution, quantifiable plasma concentrations of brimonidine were observed in 11 of the 18 subjects who received the brimonidine tartrate ophthalmic solution. Brimonidine rapidly appeared in plasma The mean Cmax was not calculated because values were not quantifiable for 7 of 18 subjects The mean AUC0-t also was not calculated."|0 Hour (prior to dose) and at 1, 2, 3, 4, 5, 6, 7, and 8 hours post-morning dose|||pg*hr/mL||Full Range|Mean
767718|NCT00697541|Primary|Cmax - Maximum Systemic Concentration of Brimonidine|Maximum observed plasma concentration|0 Hour (prior to dose) and at 1, 2, 3, 4, 5, 6, 7, and 8 hours post-morning dose|||pg/mL||Full Range|Mean
767731|NCT00697593|Primary|Biochemistry - Alanine Transaminase (ALT)|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 1 participant missing values||IU/L||Standard Deviation|Mean
767746|NCT00697593|Secondary|Static Physician’s Global Assessment (sPGA)|Number of subjects who achieve an Static Physician’s Global Assessment (sPGA) rating of clear; minimal; mild; moderate; severe; or very severe at Week 12 (Day 85).|12 Weeks/Early Termination|Safety Population||participants|||Number
767747|NCT00697593|Primary|Hematology - Hematocrit|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 4 participants missing values||packed cell volume||Standard Deviation|Mean
767748|NCT00697619|Primary|Comparing the Level of Urinary N-telopeptide (uNTx) in the Two Arms .||Baseline, the first, second and third month|||nM /mM||Standard Error|Median
767749|NCT00697697|Primary|Number of Patients Reporting at Least One Treatment Emergent Adverse Event Leading to Study Termination|A treatment emergent adverse event is one with a start date on or after the date of first administration of the study drug during the study.|40 weeks|All patients who received any study drug and who had at least one post safety evaluation were included in the adverse event analysis.||participants|||Number
767750|NCT00697697|Primary|Number of Patients With Treatment Emergent Adverse Events Related to Study Drug|A treatment emergent adverse event is one with a start date on or after the date of first administration of the study drug during the study.|40 weeks|All patients who received any study drug and who had at least one post safety evaluation were included in the adverse event analysis.||participants|||Number
767751|NCT00697788|Secondary|Heart Rate|Heart Rate recorded off EKG in beats per minute|10, 25, 40, 55, 70, 85, 100, 115 minutes after dexmedetomidine bolus administration|||heart beats per minute||Standard Deviation|Mean
767752|NCT00697788|Secondary|Oxygen Saturation|Pulse oximetry was used to measure oxygen saturation.|10, 25, 40, 55, 70, 85, 100, 115 minutes after dexmedetomidine bolus administration|||Percent of Hemoglobin Saturated||Standard Deviation|Mean
767753|NCT00697788|Secondary|Presence of Arrhythmias.|Presence of arrhythmias was studied using a 3 lead realtime EKG throughout study.|10, 25, 40, 55, 70, 85, 100, 115 minutes after dexmedetomidine bolus administration|EKG was analyzed on each participant looking for presence of arrhythmias. None were detected.||Participants|||Count of Participants
767754|NCT00697788|Primary|Percent Change in Mean Arterial Pressure (MAP)|Looking at hemodynamic response to dexmedetomidine. Mean arterial pressure primary outcome measure.|10, 25, 40, 55, 70, 85, 100, 115 minutes after dexmedetomidine bolus administration|Acutely burned pediatric patients intubated with burns >=20% between 2 and 19 years of age requiring escalating doses of morphine and midazolam||% change||Standard Deviation|Mean
767755|NCT00697801|Secondary|Change From Baseline in FEV1% Predicted|The forced expiratory volume in 1 second (FEV1) is the amount forced of air exhaled in 1 second. The percent predicted is calculated for age, gender, and height. Subjects had to perform at least 3 acceptable maneuvers into a spirometer. An increase indicates an improvement (a greater volume of air expired).|baseline, week 6|Patients with available data at specified time points are included in the analysis population.||percentage of predicted FEV1||Standard Deviation|Mean
767756|NCT00697801|Primary|Change From Baseline in Nighttime Composite Symptom Score|"The individual symptoms at each time point to be monitored are: cough, wheeze, and shortness of breath.
The individual symptoms were scored using a four point scale:
0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms
Nightly composite symptom score is based on the average of the individual symptom scores for the night. Nightime composite symptom score is defined as average of the last 5 days' nightly composite symptom scores within the last 5 nights immediately preceding the end day of that week. The range for the nighttime composite symptom score is 0 (no symptoms) to 3 (severe symptoms). A negative change indicates an improvement of symptoms and a positive change indicates a worsening of symptoms."|baseline, week 6|Patients with available data at specified time points are included in the analysis population.||units on a scale||Standard Deviation|Mean
767757|NCT00697801|Primary|Change From Baseline in Daytime Composite Symptom Score|"The individual symptoms at each time point to be monitored are: cough, wheeze, and shortness of breath.
The individual symptoms were scored using a four point scale:
0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms
Daily composite symptom score is based on the average of the individual symptom scores for a day. Daytime composite symptom score is defined as average of the last 5 days' daily composite symptom scores within the last 5 days immediately preceding the end day of that week. The range for the daytime composite symptom score is 0 (no symptoms) to 3 (severe symptoms). A negative change indicates an improvement of symptoms and a positive change indicates a worsening of symptoms."|baseline, week 6|Patients with available data at specified time points are included in the analysis population.||units on a scale||Standard Deviation|Mean
767758|NCT00697827|Secondary|Oswestry Disability Index (ODI)|The Oswestry Disability Index (ODI) is one of the principal condition-specific outcome measures used in the management of spinal disorders. There are 10 questions. The questions are designed in a way to show how the back or leg pain is affecting the patient's ability to manage in everyday life. Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. The obtained score can be multiplied by 2 to produce a percentage score. For this study,any improvement at 24 months compared to pre-operative baseline was determined as a success.|24 months|||participants|||Number
767759|NCT00697827|Primary|Zurich Claudication Questionnaire(ZCQ)|The questionnaire quantifies severity of symptoms, physical function characteristics, and patient's satisfaction. The scale relates to symptoms over the past month. The result is expressed as a percentage of the maximum possible score. The score increases with worsening disability. An individual patient treatment will be considered a success if they meet at least two of three components defined as an improvement of ≥ 0.5 as compared to preoperative score for the symptom severity and physical function and an of < 2.5 points for patient satisfaction at 24 months.|24 months|||participants|||Number
767760|NCT00698009|Primary|Number of Participants Infused Haploidentical Donor-derived Natural Killer (NK) Cells and Low-dose Interleukin-2 (IL-2)|Feasibility of an infused allogeneic donor NK cell product and IL-2 following a cyclophosphamide and fludarabine preparative regimen to treat relapsed neuroblastoma after autologous peripheral blood stem cell (PBSC) transplant where feasibility is defined as being able to infuse NK cells on day 0.|21 days, up to 1 year||||||
767781|NCT00691054|Secondary|Progression-free Survival|Median number of months participants experienced progression-free survival, according to Response Evaluation Criteria In Solid Tumors(RECIST) v1.0 criteria for target lesions and assessed by CT/MRI. Per RECIST, progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|6 months|||months||95% Confidence Interval|Median
767761|NCT00698009|Primary|Participant Disease Response|Neuroblastoma International Response Criteria: Complete Response (CR): No evidence of disease (primary and metastasis) clinically & radiographic studies, (homovanillic acid (HVA)/vanillylmandelic acid (VMA) normal). Very Good Partial Response (VGPR): >90% reduction in primary tumor, resolution all metastatic tumor except bone. No new bone lesions and improvement on scan of all pre-existing lesions; HVA/VMA decreased >90%. Partial Response (PR): 50-90% reduction primary and all measurable metastatic lesions, 0-1 bone marrow samples with tumor; scans of bone lesions same as VGPR. HVA/VMA decreased 50-90%. Mixed Response (MR): > 50% reduction any measurable disease (primary or metastases); no new lesions; <25% increase in any existing lesion (exclude bone marrow evaluation). No Response (NR): No new lesions; < 25% increase in existing lesion. Progressive Disease (PD): Any new lesions. Increase <25% in measurable lesion, previous negative bone marrow positive for tumor.|1 Year for overall patient response, or until disease progression||||||
767762|NCT00698022|Secondary|The Safety Objective is to Evaluate the Safety and Tolerability of Mifepristone in Combination With Risperidone in Healthy Male Volunteers.||28 days||||||
767763|NCT00698022|Secondary|The Secondary Study Objectives Are to Determine the Mean Percent Change in Baseline Body Weight; and the Proportion of Subjects That Gain Less Than 5% and Less Than 7% of Their Baseline Body Weight in the Treatment Groups.||28 days||||||
767764|NCT00698022|Primary|Change in Weight (kg) From Baseline to Day 28.|Change in weight (kg) was compared at Baseline and Day 28 for all subjects in all treatment arms.|baseline and 28 days|||kilograms||Standard Error|Mean
767765|NCT00698035|Secondary|Change in Vaginal Epithelium Scores|During a gynecologic exam, the vaginal epithelium was assessed by an examiner using the Vaginal Atrophy Scoring Scale to evaluate Rugae (lack of), Pallor (pinkness), Petechiae, Mucosal thinning, Dryness. Scores range from 0 (none) to 3 (severe); higher scores indicate less favorable outcomes.|Baseline, 12 weeks|Patients with both baseline and week 12 gynecologic exams for evaluation of vaginal atrophy||units on a scale||Standard Deviation|Mean
767766|NCT00698035|Secondary|Sexual Satisfaction|"Participants were asked to respond to a Sexual Satisfaction One Item Measure which asked Overall, how satisfactory to you is your sexual relationship with your partner? Response options range from 1 (Extremely unsatisfactory) to 6 (Extremely satisfactory)."|Baseline, Week 4, Week 12|Participants who provided responses to SD, SI and SS at all 3 time points: Baseline (BL), Week 4 (W4), and Week 12 (W12)||units on a scale||Standard Deviation|Mean
767767|NCT00698035|Secondary|Sexual Quality of Life|Cancer Rehabilitation Evaluation System (CARES) Sexual Dysfunction (SD) and Sexual Interest (SI) Subscales range from 0 to 4 and measure the severity of problems, with higher scores indicating more difficulty.|Baseline, Week 4, Week 12|Participants who provided responses to SD, SI and SS at 3 time points: Baseline (BL), Week 4 (W4), and Week 12 (W12)||units on a scale||Standard Deviation|Mean
767768|NCT00698035|Secondary|Total Testosterone Levels|By serum ultrasensitive total testosterone test (Quest Diagnostics)|12 weeks|Per protocol, participants assigned to the Testosterone arm who completed 12 weeks of assigned treatment and had testosterone measurement at baseline, 4 weeks and 12 weeks.||ng/dl||Standard Deviation|Mean
767769|NCT00698035|Primary|Persistently Elevated Serum Estradiol Level Outside the Post-menopausal Range|Liquid chromatography tandem mass spectrometry (Quest Diagnostics). Persistently elevated serum estradiol level outside the post-menopausal range was defined as: Serum estradiol >10 pg/dl on two consecutive collections at least 4 weeks apart. 2. If baseline estradiol was >10 pg/dl, subsequent levels >10 pg/ml higher than baseline were considered a significant elevation outside the post-menopausal range.|12 Weeks|Per protocol, to be considered evaluable for the Primary Outcome, patients must complete both baseline evaluation and week 4 safety blood draw. 1 participant in the Testosterone arm was not evaluable.||participants|||Number
767770|NCT00698035|Secondary|Matched E2 by Commercial and Research (RIA) Analyses|Serum estradiol assays sent to the UCSF clinical laboratory are sent out to Quest Diagnostics, which uses LC/MS for their ultra-sensitive estradiol assay. Samples were also sent to a specialized research lab in England which has developed an ultrasensitive assay using radioimmunoassay (RIA) after ether extraction (sensitivity limit of 3pmol/l) to quantify low levels of estradiol found in post-menopausal women|baseline, 4 weeks|Patients from both study arms arms with matched pairs of baseline and week 4 E2 performed by both commercial and research labs||pg/ml||Standard Deviation|Mean
767771|NCT00698035|Secondary|Serum Estradiol (E2)|serial measurements of serum estradiol (E2) by liquid chromatography tandem mass spectrometry (Quest Diagnostics)|12 weeks|Per protocol, participants who completed 12 weeks of assigned treatment||pg/ml||Standard Deviation|Mean
767772|NCT00698139|Secondary|Changes in Renin||baseline and 6 hours||||||
767773|NCT00698139|Secondary|Changes in Norepinephrine||baseline and 6 hours||||||
767774|NCT00698139|Secondary|Changes in B-type Natriuretic Peptide (BNP)|B-type natriuretic peptide (BNP) was measured for all subjects to determint the difference between pre- and post-procedure.|baseline and 6 hours|||ng/L||Standard Deviation|Mean
767775|NCT00698139|Secondary|Changes in Thoracic Impedence|Impedence will be measured using the pacemaker programmer to determine the difference in thoracic impedence pre- and post-procedure.|baseline and 6 hours|||ohm||Standard Deviation|Mean
767776|NCT00698139|Primary|Change in Cardiac Output (CO)|The difference between post and pre CO|baseline and 6 hours|||L/min||Standard Deviation|Mean
767777|NCT00698204|Secondary|Evaluation of Pain Severity at 5000 cGy Radiation|Mean worst pain at 5000 cGy on 0-10 scale, 0 = no pain, 10 = worst pain imaginable|5 weeks from start of radiation therapy (cumulative dose of 5000 cGy)|Only subjects who were still taking the study drug (celecoxib or placebo) when cumulative radiation dose of 5000 cGy was reached are included in this analysis (19 of 20 in each group were analyzed).||units on a scale||Standard Deviation|Mean
767778|NCT00698204|Primary|Clinical Oral Mucosal Injury Score at Cumulative Radiation Dose of 5000 cGy|"Oral Mucositis Assessment Scale (OMAS) was used to assess oral mucosal injury during the period of radiation therapy. This validated scale scores ulceration and erythema independently at nine specified sites in the oral cavity. Ulceration is scored from 0-3 based on size of lesion and erythema is scored from 0-2 based on severity of erythema. The sum of scores is then divided by 9.
The mean OMAS score at a cumulative radiation dose of 5000 cGy (approximately 5 weeks of treatment) was compared between groups."|5 weeks from start of radiation therapy (5000 cGy)|Subjects participating in the study as they reached a cumulative dose of 5000 cGy were included. One subject in the celecoxib group withdrew prior to reaching 5000 cGy.||units on a scale||Standard Deviation|Mean
767783|NCT00691054|Secondary|Number of Participants Showing Complete or Partial Response|Number of participants showing complete or partial response to protocol therapy according to Response Evaluation Criteria In Solid Tumors(RECIST) v1.0 criteria for target lesions and assessed by CT/MRI. Per RECIST, Complete Response (CR) = Disappearance of all target lesions; Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|6 months|||participants|||Number
767784|NCT00691054|Primary|Overall Survival Rate at 6 Months|Overall survival was measured from the start of treatment (date of first dose of Abraxane® therapy) to date of death due to any cause. For patients who are alive, follow-up time will be censored at date of last contact.|6 months|||percentage of participants||95% Confidence Interval|Number
767785|NCT00691093|Secondary|Reasons for Study Treatment Dose Changes|Possible change in the dose and the reasons for the change were collected and documented.|Month 3 or ET|SAS||participants|||Number
767786|NCT00691093|Secondary|Study Doses|Number of subjects that changed doses throughout the study period.|Month 3 or ET|SAS||participants|||Number
767787|NCT00691093|Secondary|Time To Onset Of Treatment Response|Participant's perception of treatment response assessment since the previous visit was noted at each visit. Time to onset of response was calculated in weeks from start of treatment.|Month 1, Month 2, Month 3 or ET|FAS||weeks||Full Range|Median
767788|NCT00691093|Secondary|Change From Baseline in Total Scores of OAB-q at Visit 4|Symptom severity/bother score: sub-section of the OAB-q consists of 8 questions. Each item assessed on ordinal scale (0=Not at all to 5=a very great deal). Score=sum of scores for items 1 to 8 and a further 2 points were added if subject was male. Lowest possible score=0 and highest=42. Data were transformed onto a 0 to 100 scale and analyzed based on the transformed score: Transformed Symptom Bother Score=[(Actual Total Raw Score minus Lowest possible value of raw score) divided by Range] multiplied by 100. Higher scores=greater symptom severity or bother and lower=minimal symptom severity.|Baseline, Month 3 or ET|FAS||scores on a scale||Standard Deviation|Mean
767789|NCT00691093|Primary|Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Visit 2, Visit 3, and Visit 4|The mean number of UUI episodes: total number of UUI episodes, divided by the total diary days collected at that visit.|Baseline, Month 1, Month 2, Month 3 or ET|FAS||episodes||Standard Deviation|Mean
767790|NCT00691093|Primary|Change From Baseline in Urgency Episode Frequency (UEF) Per 24 Hours at Visit 2, Visit 3, and Visit 4|UEF: mean number of micturition related urgency episodes per 24 hours and calculated as the total number of ‘urgency’ urinations (i.e., sudden urges to urinate and problems to delay micturition) divided by 3 (or if data for 3 days were not available, over the total number of diary days collected at that visit).|Baseline, Month 1, Month 2, Month 3 or ET|FAS||episodes||Standard Deviation|Mean
767791|NCT00691093|Primary|Change From Baseline in Nocturnal Micturition Frequency Per 24 Hours at Visit 2, Visit 3, and Visit 4|Nocturnal frequency: mean number of ‘night time’ (the time the participant was asleep and the urge to urinate woke him/her up) micturitions and calculated as the total number of ‘night time’ urinations, divided by the total diary days collected at that visit.|Baseline, Month 1, Month 2, Month 3 or ET|FAS||episodes||Standard Deviation|Mean
767792|NCT00691093|Secondary|Overactive Bladder Questionnaire (OAB-q): Symptom Severity/Bother Scale|Symptom severity/bother score: sub-section of the OAB-q consists of 8 questions. Each item assessed on ordinal scale (0=Not at all to 5=a very great deal). Score=sum of scores for items 1 to 8 and a further 2 points were added if subject was male. Lowest possible score=0 and highest=42. Data were transformed onto a 0 to 100 scale and analyzed based on the transformed score: Transformed Symptom Bother Score=[(Actual Total Raw Score minus Lowest possible value of raw score) divided by Range] multiplied by 100. Higher scores=greater symptom severity or bother and lower=minimal symptom severity.|Baseline, Month 3 or ET|FAS||scores on a scale||Standard Deviation|Mean
767793|NCT00691093|Secondary|Efficacy and Tolerability Compared to Previous Medication (Overall Treatment Effect Scale) at Visit 4|Overall Treatment Effect Scale: 3 questions from which a numeric score was derived. If a subject answered ‘(2) About the same’ to question 1 then a score of 0 was given. If a subject answered ‘(1) Worse’ to question 1, then a score between -7=a very great deal worse to -1=Almost the same, hardly worse at all was given depending on severity of their symptoms (determined from answer to question 2). If a subject answered ‘(3) Better’ to question 1, then a score ranging from 1=Almost the same, hardly better at all to 7=A very great deal better, depending on their answer to question 3, was given.|Month 3 or ET|FAS||scores on a scale||Standard Deviation|Mean
767794|NCT00691093|Secondary|Clinical Global Evaluation of Fesoterodine|Clinical global evaluation of study medication was assessed via the question ‘how would you rate the study medication the patient received for overactive bladder?,’ and was assessed on the four point categorical scale, ranging from ‘Poor’ to ‘Excellent.’|12 weeks|SAS||participants|||Number
767795|NCT00691093|Secondary|Patient's Global Evaluation of Fesoterodine|The patients global evaluation of study medication was assessed via the question 'how would you rate your overall response to the study medication?’ and was assessed on the four point categorical scale, ranging from ‘Poor’ to ‘Excellent'.|Baseline, Month 3 or ET|The safety analysis set (SAS) included all subjects who enrolled in the study, signed informed consent and received at least one dose of study medication.||participants|||Number
767796|NCT00691093|Secondary|Change From Baseline in Post Void Residual (PVR) Urine Volume at Visit 2, Visit 3, and Visit 4|The PVR urine volume: measured by an ultrasound scan.|Baseline, Month 1, Month 2, Month 3 or ET|FAS||ml||Standard Deviation|Mean
767797|NCT00691093|Primary|Change From Baseline in Micturition Frequency Per 24 Hours at Each Visit|Micturition frequency: mean number of ‘day time’ (i.e., the time the participant was awake) micturitions per 24 hours and calculated as the total number of ‘day time’ urinations, divided by the total diary days collected at that visit.|Baseline, Month 1, Month 2, Month 3 or Early Termination (ET)|The full analysis set (FAS) included all patients who received at least one dose of the study medication and who had at least one post baseline efficacy measurement.||episodes||Standard Deviation|Mean
767798|NCT00691132|Secondary|Urinary Levels of [Pyridine-D4]Hydroxy Acid:Total [Pyridine-D4]NNAL Ratio by GSTM1 and GSTT1 Genotype.|% Difference in ratio of urinary [pyridine-D4]hydroxy acid : total [pyridine-D4]NNAL while on PEITC compared to while on Placebo ((PEITC - Placebo) / PEITC) x 100%|After 5 days of treatment|||percentage of change in ratio||95% Confidence Interval|Geometric Mean
772211|NCT00733096|Secondary|Oswestry Disability Score|0-100%. 0= no disability, 100% is complete disability|1 month|Patients who received epidural steroid injections||percentage of disability out of 100%||95% Confidence Interval|Mean
767800|NCT00691132|Secondary|Effects of GSTT1 Genotype on Phenethyl Isothiocyanate (PEITC)-NNK Association and on the Metabolism and Excretion of PEITC|Measured by high-performance liquid chromatography (HPLC). The aim is to determine the possible differential effects of GSTT1 genotype on PEITC excretion, using the method of Chung et al. The method will result in quantitative recovery of the PEITC-NAC.|After 5 days of treatment|||nmol/mg creatinine||95% Confidence Interval|Geometric Mean
767801|NCT00691132|Secondary|Effects of GSTM1 Genotype on Phenethyl Isothiocyanate (PEITC)-NNK Association and on the Metabolism and Excretion of PEITC|Measured by high-performance liquid chromatography (HPLC). The aim is to determine the possible differential effects of GSTM1 genotype on PEITC excretion, using the method of Chung et al. The method will result in quantitative recovery of the PEITC-NAC.|After 5 days of PEITC treatment|||nmol/mg creatinine||95% Confidence Interval|Geometric Mean
767802|NCT00691132|Primary|Urinary Levels of Biomarkers of NNK Metabolism|The ratio of urinary [pyridine-D4]hydroxy acid : total [pyridine-D4]NNAL will be measured. This ratio is not expected to be influenced by the number of cigarettes smoked per day, or smoking topography.|After 5 days of treatment|||pmol/mg creatinine||95% Confidence Interval|Geometric Mean
767803|NCT00691132|Primary|Urinary Levels of Biomarkers of NNK Metabolism|Urinary levels of Total ITC and PEITC-NAC by treatment sequence groups and treatment period.|2 periods, 5 days each on PEITC or Placebo, with washout week between|||pmol/mg creatinine||95% Confidence Interval|Geometric Mean
767804|NCT00691197|Post-Hoc|Patient Preference|Percentage of patients who used pre-study rewetting drops and answered “Agree” or “Strongly Agree” when asked if they preferred the study drops (SD) over their pre-study drops(PSD).|Day 30|Responders Completed Population||Percentage of participants|||Number
767805|NCT00691197|Secondary|Corneal Staining|Corneal staining of greater or equal to grade 2 at day 90. Grading scale: 0 = None Present; 1 = Trace Finding; 2 = Mild Finding; 3 = Moderate Finding; 4 = Severe Finding|Day 90|Completed Population||Participants|||Number
767806|NCT00691197|Post-Hoc|Patient Acceptability|"A questionnaire was administered to all patients to evaluate the acceptability of the Rewetting Drops (RD) with use with Contact Lenses (CL). Table below shows the percentage of participants responding either Agree or Strongly Agree at day 90. Number of participants answering question is indicated as (number of Test subjects/number of Control subjects)"|Day 90|Intent to Treat Population||Percentage of Participants|||Number
767807|NCT00691197|Primary|Best Corrected Visual Acuity|Percentage of Subjects Tabulated by Changes in Line Number at Day 90 from Baseline; Visual Acuity measured by LogMar reported as Snellen equivalents. Better: an increase of 2 lines or more in at least one eye; No Change: a change less than +/- 2 lines in both eyes; Worse: a decrease of 2 lines or more in at least one eye.|Change from Baseline at Day 90|Completed Population||Percentage of Participants|||Number
767808|NCT00691210|Primary|The Maximum Tolerated Dose of Niacinamide in the Combination of Vorinostat and Niacinamide||3 years|||mg/kg|||Number
767809|NCT00691210|Secondary|Pharmacodynamic Markers of Target Effect in Paired Tissue Biopsies||continuous||||||
767810|NCT00691210|Secondary|The Prevalence of Anti-tumor Activity||continuous||||||
767811|NCT00691210|Secondary|The Number of Dose Delays and Reductions at the MTD||continuous||||||
767812|NCT00691210|Secondary|The Greatest Number of Cycles Received in Each Treatment Group|The highest number of cycles received by an individual participant in the treatment groups. Each cycle was 21 days long.|up to 45 weeks|||cycles|||Number
767813|NCT00691327|Secondary|Satisfaction With Breast Implants as Determined by Patients and Physicians on a 5-point Scale|Satisfaction score on a 5-point scale, where 1 is definitely dissatisfied and 5 is definitely satisfied|5 years|All patients who had a breast implant satisfaction rating||Units on a scale||Standard Deviation|Mean
767814|NCT00691327|Primary|Local Complications|By patient risk of complications occurring in at least 5% of patients in 1 or more cohorts|5 years|All enrolled patients||Percentage by Patient||95% Confidence Interval|Number
767815|NCT00691483|Other Pre-specified|Change From Baseline in Fagerström Test for Nicotine Dependence (FTND) to Day of First Quit Attempt (FQA) Through Week 5 by Smoking Status at Weeks 9-12|Change in nicotine dependence from baseline to the date of the FQA within the first 5 weeks. FTND was designed to provide an ordinal measure of nicotine dependence related to cigarette smoking. It contains items that evaluate the quantity of cigarette consumption, the compulsion to use, and dependence. The FTND contains 4 yes-no and 2 multiple choice questions and can be used in a self-report format. The items on FTND are scored 0 to 3 for multiple choice items, the items are summed to yield a total score of 0-10 (0=minimum nicotine dependence; 10=maximum nicotine dependence).|Baseline through Week 5|Number of participants analyzed = participants with FQA through Week 5, excluding 157 participants for whom FTND was not done at the time of FQA (1 participant also had inconsistent FQA date with first dosing date). Analysis done by smoking status at Week 12 (Responder for the primary endpoint of CA Weeks 9-12).||Units on a scale||Standard Deviation|Mean
767816|NCT00691483|Secondary|Percentage of Participants With 4-week Point Prevalence of Nonsmoking|Percentage of participants with complete abstinence from cigarette smoking or use of tobacco products for the 4 weeks prior to Week 24 who did not have CO >10 ppm at any visits.|Week 24|"FAS. Missing inventory interview questions of whether the subject had smoked or used any other tobacco products in the last 4 weeks were not imputed. Missing CO was imputed as =<10 ppm."||Percentage of participants|||Number
767817|NCT00691483|Secondary|Percentage of Participants With 7-day Point Prevalence of Nonsmoking (Smoking Cessation)|Percentage of participants with complete abstinence from cigarette smoking or other nicotine-containing (treatment phase) or tobacco (non-treatment phase) products use for the 7 days prior to Week 12 and Week 24, respectively, who did not have CO >10 ppm at any visits. CO-confirmed in-clinic visit.|Week 12 and Week 24|"FAS. Missing weekly interview questions of whether the subject had smoked in the last 7 days were not imputed; missing CO was imputed as =<10 ppm."||Percentage of participants|||Number
767818|NCT00691483|Secondary|Percentage of Participants With Long Term Quit Through Week 24|Responder for the primary endpoint of CA from Week 9 through Week 12 and who had no more than 6 days of smoking during the non-treatment phase of the study. For Weeks 13, 16, 20, and 24, long term quit was determined by CO-confirmed in-clinic visit.|Week 9 through Week 24|FAS. If the number of days smoked was missing for a subject visit, the CA responder status of the subject at that visit determined the imputation.||Percentage of participants|||Number
772212|NCT00733096|Primary|Numerical Rating Leg Pain Score|0-10 pain score. 0= no pain, 10= worst imaginable pain.|1 month|Patients who received epidural steroid injections||units on a scale||95% Confidence Interval|Mean
767819|NCT00691483|Secondary|Percentage of Participants With Continuous Abstinence (CA) From Smoking Weeks 9-24|Percentage of participants with CA from cigarette smoking and other nicotine-containing (treatment phase) or tobacco (non-treatment phase) products use, who did not have CO >10 ppm at any visits Week 9 through Week 24. A participant was considered a responder if they met the following criterion: said they had not smoked or used nicotine products ‘since the last visit’ and did not have CO >10 ppm.|Week 9 through Week 24|FAS. Missing CO measurements imputed as =<10 ppm. Missing visit(s) imputed based on next available visit. Subjects who discontinued study and were lost to follow up were assumed smokers. Missing data not imputed from other weekly interview questions.||Percentage of participants|||Number
767820|NCT00691483|Primary|Percentage of Participants With 4-week Continuous Abstinence (CA)|The percentage of participants who reported complete abstinence from cigarette smoking and other nicotine use (on the Nicotine Use Inventory) and who did not have carbon monoxide (CO) >10 parts per million (ppm) at any visits Week 9 through Week 12. A participant was considered a responder if they met the following criterion: said they had not smoked or used nicotine products ‘since the last visit’ and did not have CO >10 ppm.|Week 9 through Week 12|Full analysis set (FAS): took at least 1 dose, including partial doses, of randomized study drug. Missing CO measurements imputed as =<10 ppm. Missing visit(s) imputed based on next available visit. Subjects who discontinued study and were lost to follow up were assumed smokers. Missing data not imputed from other weekly interview questions.||Percentage of participants|||Number
767821|NCT00698451|Secondary|The Secondary Efficacy Endpoints is Duration of Objective Response.|Objective Response Rate to Treatment Defined as the Proportion of Patients With a Complete Response (CR) or Partial Response (PR) Where a Complete response (CR) is the disappearance of all target lesions and a Partial Response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Duration of response: Duration of response was defined only for subjects with CR or PR as the best overall response. It was calculated from the date of first documentation of response to the date of disease progression or death due to progressive disease.|Duration of response was defined only for subjects with CR or PR as the best overall response. It was calculated from the date of first documentation of response to the date of disease progression or death due to progressive disease.|ITT||Days||Full Range|Median
767822|NCT00698451|Primary|The Primary Efficacy End Point is the Number of Patients With an Objective Response.|Objective Response Rate to Treatment is defined as the Proportion of Patients With a Complete Response (CR) or Partial Response (PR). A Complete Response (CR) is the disappearance of all target lesions and a Partial Response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD|Approximately 280 days (from start of treatment to the end of 10 cycles of treatment where each cycle is 28 days)|ITT||Participants|||Number
767823|NCT00698516|Secondary|Overall Survival|Overall survival is defined as the time from initiation of investigational product to death due to any cause. For participants who did not die, the time of last contact was used.|Baseline to disease progression or death (up to 82.4 weeks)|ITT Population||weeks||95% Confidence Interval|Median
767824|NCT00698516|Secondary|Time to Tumor Response (CR and PR)|Tumor response was determined using the RECIST guidelines. CR: disappearance of all target lesions. PR: >=30% decrease in sum of LD of target lesions, taking as reference the baseline sum LD. Time to response is defined as the time from initiation of investigational product to the time of first documented response (CR or PR).|Baseline to disease progression or death (up to 82.4 weeks)|Participants from the ITT Population who had CR and PR||weeks||95% Confidence Interval|Median
767825|NCT00698516|Secondary|Duration of Tumor Response (CR and PR)|Tumor response was determined using the RECIST guidelines. CR: disappearance of all target lesions. PR: >=30% decrease in sum of LD of target lesions, taking as reference the baseline sum LD. Duration of response is defined as the time from start of response (CR or PR) until progression or death due to any cause. For participants who did not progress or die, the time of initiation of post-treatment anti-cancer therapy or the time of last contact was used.|Baseline to disease progression or death (up to 82.4 weeks)|Participants from the ITT Population who had CR and PR||weeks||95% Confidence Interval|Median
767826|NCT00698516|Secondary|Number of Participants With a Tumor Response (CR and PR)|Tumor response was determined using the RECIST guidelines. CR: disappearance of all target lesions. PR: >=30% decrease in sum of LD of target lesions, taking as reference the baseline sum LD.|Baseline to disease progression or death (up to 82.4 weeks)|ITT Population||participants|||Number
767827|NCT00698516|Secondary|Number of Participants With Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)|Tumor response was determined using the RECIST guidelines.CR, disappearance of all target lesions; PR, >=30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; SD, neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since treatment started; PD, >=20% increase in sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Baseline to disease progression or death (up to 82.4 weeks)|ITT Population||participants|||Number
767828|NCT00698516|Secondary|PFS - Overall|Progression-free survival at any site was defined as the time from initiation of investigational product to the time of first documented disease progression or death due to any cause. Progression was assessed using the RECIST guidelines: >= 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since treatment started, or appearance of new lesion (s). For participants who did not progress or die, the time of initiation of post-treatment anti-cancer therapy or the time of last contact was used.|Baseline to disease progression or death (up to 82.4 weeks)|ITT Population||weeks||95% Confidence Interval|Median
767829|NCT00698516|Primary|Percentage of Participants With Progression-free Survival (PFS) at 3 Months|PFS = time from initiation of drug to time of first disease progression/death due to any cause. Progression assessed using Response Evaluation Criteria (RECIST): >=20% increase in sum of longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since treatment started, or appearance of new lesion(s). If participant did not progress or die, the time of initiation of post-treatment anti-cancer therapy or time of last contact used. PFS at 3 months calculated by taking the Kaplan-Meier (KM) estimate at 90 days from the initiation of treatment. SE = standard error.|3 months|Intent-to-Treat (ITT) Population: all participants who received at least one dose of study medication||percentageof participants|||Number
767830|NCT00698581|Secondary|The Number of Patients Reporting at Least One Serious Adverse Event (SAE) During the Course of the Study||Baseline through Re-conversion (approximately 31 weeks)|The Intention-to-Treat (ITT) Set consists of all randomized subjects with at least one intake of study medication.||Participants|||Number
767831|NCT00698581|Secondary|The Number of Patient Withdrawal Due to Adverse Events (AEs) During the Course of the Study||Baseline through Re-conversion (approximately 31 weeks)|The Intention-to-Treat (ITT) Set consists of all randomized subjects with at least one intake of study medication.||Participants|||Number
767832|NCT00698581|Secondary|The Number of Patients Reporting at Least One Treatment-Emergent Adverse Event (TEAE) During the Course of the Study||Baseline through Re-conversion (approximately 31 weeks)|The Intention-to-Treat (ITT) Set consists of all randomized subjects with at least one intake of study medication.||Participants|||Number
767833|NCT00698581|Primary|The Cumulative Exit Rate at 112 Days After the Beginning of the Baseline Antiepileptic Drug (AED) Tapering Phase|The cumulative exit rate was estimated using Kaplan-Meier methods and was based on the duration between start of the Evaluation Period (EP) and the earliest date the first exit criterion was met for each subject. Subjects completing the EP without meeting an exit criterion were censored on Day 112. The primary comparison was BRV 50 mg/day vs a historical control. The upper limit of the 2-sided 95 % Confidence Interval for the estimate was compared to the historical lower bound estimate of 0.722.|From Week 1 up to Week 17|The Efficacy Analysis Set (EFF) consists of all randomized subjects with at least one intake of study medication who also entered into the Baseline antiepileptic drug (AED) Tapering Period and started the withdrawal of Baseline AEDs.||proportion of subjects||95% Confidence Interval|Number
767840|NCT00699842|Secondary|Safety With Dose Escalation|Safety (type, frequency, severity, and relationship of adverse events to study treatment) with dose escalation.|2 years||||||
767841|NCT00699842|Primary|Determine CR, PR, and Rate of Stable Disease in MDS Patients|Determine CR, PR, and rate of stable disease in MDS patients, IPSS Score LOW or INT-1 who do not have the 5q- cytogenetic abnormality according to the IWG criteria for response in >10mg doses of lenalidomide|2 years||||||
767842|NCT00699972|Secondary|Percent Change in the 28-day Complex Partial Plus Secondarily Generalized Seizure Frequency From Baseline to the End of the Double-blind Phase (Titration and Maintenance Phases)|Percent Change in the Seizure frequency per 28 days was derived from the information recorded in the subject diaries.|Baseline (Pre-randomization) through Week 19|Full ITT Analysis Set. One subject in Arm 3 was treated for 1 day prior to being excluded.||Percent Change||Full Range|Median
767843|NCT00699972|Secondary|Responder Rate|The responder rate for the Full ITT Analysis Set from the maintenance LOCF (Last Observation Carried Forward). A responder was a subject who had a 50 percent or greater reduction in seizure frequency per 28 days from the Pre‑randomization phase.|Baseline (Pre-randomization) through Week 19|Full ITT Analysis Set. One subject in Arm 3 was treated for 1 day prior to being excluded.||Percentage of Participants|||Number
767844|NCT00699972|Primary|Percent Change in the 28-day Seizure Frequency From Baseline to the End of the Double-blind Phase (Titration and Maintenance Phases)|Seizure frequency per 28 days was derived from the information recorded in the subject diaries.|Baseline (Pre-randomization) through Week 19|Full Intent-to-Treat (ITT) Analysis Set - group of subjects who were randomized to study drug, received study drug, and had any seizure frequency data during the Double-blind Phase. One subject in Arm 3 was treated for 1 day prior to being excluded.||Percent Change||Full Range|Median
767845|NCT00699998|Secondary|Summary of All Deaths|All deaths, regardless of possible relatedness, with the exception of 1 event, were adjudicated by the Clinical Endpoint Committee (CEC) and are reported in this table. The 1 event which was not adjudicated was a result of the revocation of consent by the participant prior to their death. Deaths possibly related to study drug in the opinion of the investigator are also contained in the Serious Adverse Event (SAE) module.|Randomization through end of study (30-month visit)|All randomized participants||participants|||Number
767867|NCT00700063|Primary|Incidence Rate and Severity of LSRs Following Study Medication Application|"The treatment area was assessed at baseline, Day 1 (pre-dose), and at each subsequent study visit for the presence and grade (0 to 4) of the following LSRs: erythema; flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration. A composite LSR score (0 to 24), reflecting the sum of each individual LSR grade, was calculated for each patient at each visit.
The actual value and change from baseline in the composite LSR score were also summarized."|Baseline|One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.||scores on a scale||Standard Deviation|Mean
775451|NCT00756977|Secondary|Serum Chemistry Results (U/L)|Change from Baseline|2 days|Intent-to-treat population: all patients that took any portion of the study preparation.||U/L||Standard Deviation|Mean
767846|NCT00699998|Secondary|Economic and Quality of Life Outcomes|Seattle Angina Questionnaire (SAQ) is a validated, disease-specific questionnaire containing 11 questions (Q) yielding 5 summary scales related to angina: physical limitations, angina stability, angina frequency, treatment satisfaction and disease perception. In this study only angina frequency and the physical limitations scales were assessed. Anginal Frequency was assessed using Q3 and Q4 which consists of a Likert scale ranging from 1 to 6 (higher values equals better quality of life) to assess how often a patient is having symptoms now. Physical limitations was assessed using Q1 which contains 9 items each assessed via Likert scale ranging from 1 to 6 (higher values equals better quality of life) to assess how much a participant's condition is hampering their ability to do what they want to do. Scale scores are transformed to a 0-100 by subtracting the lowest possible score, dividing by the range of the scale, and multiplying by 100. Higher values equal better quality of life.|Baseline and follow-up (24 months)|All randomized participants (combined <75 years and 75 years and older) with SAQ data.||units on a scale||Standard Deviation|Mean
767847|NCT00699998|Secondary|Genotyping Related to Drug Metabolism|Variation in the genes encoding the cytochrome P450 (CYP) enzymes (CYP2C19) can reduce the ability to metabolize clopidogrel and a reduced platelet response and have been associated with increased rates of CV events including CV death. Participants were classified as extensive metabolizers (EM); reduced metabolizers (RM); or unknown (UNK) metabolizers based on their CYP2C19 genotype. Possible extensive metabolizer (EM) phenotypes include EM=extensive metabolizer, UM=ultra-rapid metabolizer, and EM (non-UM) that are not UM. Possible reduced metabolizer (RM) phenotypes include IM=intermediate metabolizer and PM=poor metabolizer. Genotypes associated with each predicted phenotype are presented; predicted phenotype is presented first followed by the genotype. Percentage=(number of participants with the predicted phenotype and genotype divided by the total number of participants per arm) multiplied by 100.|Baseline|All randomized participants who provided a DNA sample.||percentage participants with geneotype|||Number
767848|NCT00699998|Secondary|Biomarker Measurements of Inflammation/Hemodynamic Stress: C-Reactive Protein (CRP)|C-Reactive Protein (CRP) is a biomarker associated with inflammation and increased CV risk. Results are presented as geometric least squares means (Geometric LS means). Geometric LS means were adjusted for treatment + baseline value + clopidogrel status at randomization.|Day 30 and Month 6|All randomized participants who received at least 1 dose of study therapy and had baseline and post-baseline CRP measurement at Day 30 or 6 Months.||milligrams per liter (mg/L)||Standard Error|Geometric Mean
767849|NCT00699998|Secondary|Biomarker Measurements of Inflammation/Hemodynamic Stress: Brain Natriuretic Peptide (BNP)|Brain natriuretic peptide (BNP) is secreted by the ventricles of the heart in response to hemodynamic stress and is a biomarker associated with increased CV risk. Results are presented as geometric least squares means (Geometric LS means). Geometric LS means were adjusted for treatment + baseline value + clopidogrel status at randomization.|Day 30 and 6 Months|All randomized participants who received at least 1 dose of study therapy and had baseline and post-baseline BNP measurement at Day 30 or 6 Months.||picograms per milliliter (pg/mL)||Standard Error|Geometric Mean
767850|NCT00699998|Secondary|Platelet Aggregation Measures|Platelet aggregation was measured by as measured by Accumetrics Verify Now™ P2Y12. Results were reported in P2Y12 Reaction Units (PRU). PRU represents the rate and extent of adenosine (ADP)-stimulated platelet aggregation. Lower values indicate greater P2Y12 platelet inhibition and lower platelet activity and aggregation. ANCOVA Model was used and values were corrected for treatment + baseline value + clopidogrel status at randomization.|Day 30 and 12 Months|All participants who received at least 1 dose of study drug, and had a baseline and post-baseline PRU measurement at Day 30 or Month 12.||P2Y12 Reaction Units (PRU)||Standard Error|Least Squares Mean
767851|NCT00699998|Secondary|Percentage of Participants With a Composite Endpoint of All-cause Death, MI, or Stroke|The percentage of participants is the total number of participants experiencing an all-cause death, nonfatal MI, or nonfatal stroke divided by number of participants in the treatment arm. Endpoint events were adjudicated by the Clinical Endpoint Committee.|Randomization through end of study (30-month visit)|All randomized participants||percentage of participants with an event|||Number
767852|NCT00699998|Secondary|Percentage of Participants With a Composite Endpoint of CV Death, MI, Stroke, or Re-hospitalization for Recurrent Unstable Angina (UA)|The percentage of participants is the total number of participants experiencing a CV death, nonfatal MI, nonfatal stroke or re-hospitalization for a recurrent UA divided by number of participants in the treatment arm. Endpoints events were adjudicated by the Clinical Endpoint Committee.|Randomization through end of study (30-month visit)|All randomized participants||percentage of participants with an event|||Number
767853|NCT00699998|Secondary|Percentage of Participants With a Composite Endpoint of CV Death and MI|The percentage of participants is the total number of participants experiencing a CV death or nonfatal MI divided by number of participants in the treatment arm. Endpoint events were adjudicated by the Clinical Endpoint Committee.|Randomization through end of study (30-month visit)|All randomized participants||percentage of participants with an event|||Number
767854|NCT00699998|Primary|Percentage of Participants With a Composite Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Stroke|The percentage of participants is the total number of participants experiencing a CV death, nonfatal MI, or nonfatal stroke divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.|Randomization through end of study (30-month visit)|All randomized participants||percentage of participants with an event|||Number
767855|NCT00700011|Primary|To Determine the Non-hematologic Toxicity Profile of This Dose Schedule (Grade 2 and Above)|Assess for adverse events in all the patients receiving the Clofarabine at the dose schedules described in the protocol (CTCAE 3.0 used).|biweekly for duration of treatment , an average of 3 months|All participants considered.||participants|||Number
767868|NCT00700063|Primary|Incidence of SAE Recorded Throughout the Study|Incidence of SAE recorded throughout the study|57 days|One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.||participants|||Number
767869|NCT00700063|Secondary|Efficacy (Clearance of AK Lesions) Partial Clearance Rate|Partial clearence rate, defined as the number of patients at the Day 57 visit with a 75% or greater reduction in the number of AK lesions identified at baseline, in the Face and Scalp|57 days|||participants|||Number
767870|NCT00700063|Primary|Incidence of AEs Recorded Throughout the Study|Incidence of AEs recorded throughout the study|57 days|One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.||participants|||Number
767856|NCT00700011|Primary|Determine Frequency and Duration of Bone Marrow Responses to IV Clofarabine|The International Working Group response criteria was used. Complete remission is defined as <5 % marrow blasts without evidence of dysplasia and normalization of the peripheral blood counts, including hemoglobin >11 g/dL, neutrophil count of >1 x 10^9/L. and platelet count of >100 x 10^9/L. Patients must also be transfusion-independent and not require any recombinant erythropoietin. Partial remission (PR) is defined as: satisfying complete remission criteria if abnormal before treatment, except that blasts are reduced by 50% or more compared to pretreatment levels, but still >5 %. Stable disease is defined as: failure to achieve at least a PR but without evidence of disease progression for at least 8 weeks.Progression of disease is defined as: disease progression with worsening cytopenias. Best response of these patients is used in the determination for this outcome below.|2-3 months|All patients considered except one on the 5 mg/m2 arm who we didn't have enough time to assess response as he died within 2 weeks after receiving cycle 1.||participants|||Number
767857|NCT00700011|Secondary|Number of Participants With DNA Hypomethylation During the Study|Since we previously observed decreases in DNA methylation in tumor cells after in vitro treatment with Clofarabine, we compared the long interspersednuclear element-1 methylation of genomic DNA obtained from CD3-depletedperipheral blood mononuclear cells between day 1 and day 5 of each cycle of Clofarabine.|assessed twice per cycle|All participants were considered except one patient on 5 mg/m2 arm who died within 2 weeks after cycle 1, so this was unassessable.||participants|||Number
767858|NCT00700011|Primary|Improvement in Peripheral Blood Count and Reduction in Number of Transfusions|Hematologic improvement will be an increased Hemoglobin of 1.5 g/dL or a reduction in the need for PRBC transfusions by at least 4 units over an 8 week period, at least 100% increase and an ANC of >0.5 x 10^9/L and an absolut platelet count increase of >30 x 10^9/L for patients who start at > 20 x 10^9/L, or increase from <20 x 10^9/L to >20 x 10^9/L and by at least 100%.|2-3 months|All patients considered for analysis except for one on the 5 mg/m2 arm who died within 2 weeks after cycle one making this unassessable for that patient.||participants|||Number
767859|NCT00700063|Primary|Complete Clearance Rate of AK Lesions;|Defined as the number of patients at the day 57 post-treatment visit with no clinically visible AK lesions in the selected treatment area|Day 57|||participants|||Number
767860|NCT00700063|Primary|Incidence of Scarring Following Study Medication Application|The selected treatment area was assessed for scarring at baseline (Day 1 pre-dose), Day 57, and at each poststudy followup visit as warranted. If any scarring was present, the significance and extent of scarring was recorded. At all timepoints, pigmentation evaluations were performed by a board certified Dermatologist (or equivalent).|Day 57|One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.||participants|||Number
767861|NCT00700063|Primary|Incidence of Scarring Following Study Medication Application|The selected treatment area was assessed for scarring at baseline (Day 1 pre-dose), Day 57, and at each poststudy followup visit as warranted. If any scarring was present, the significance and extent of scarring was recorded. At all timepoints, pigmentation evaluations were performed by a board certified Dermatologist (or equivalent)|Baseline|One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.||participants|||Number
767862|NCT00700063|Primary|Incidence of Hypopigmentation Following Study Medication Application|The selected treatment area was assessed for hypopigmentation at baseline (Day 1 pre-dose), Day 57, and at each poststudy followup visit as warranted. If any pigmentation was present, the significance and extent of pigmentation and scarring was recorded. At all timepoints, pigmentation evaluations were performed by a board certified Dermatologist (or equivalent)|Day 57|One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.||participants|||Number
767863|NCT00700063|Primary|Incidence of Hypopigmentation Following Study Medication Application|The selected treatment area was assessed for hypopigmentation at baseline (Day 1 pre-dose), Day 57, and at each poststudy followup visit as warranted. If any pigmentation was present, the significance and extent of pigmentation and scarring was recorded. At all timepoints, pigmentation evaluations were performed by a board certified Dermatologist (or equivalent)|Baseline|One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.||participants|||Number
767864|NCT00700063|Primary|Incidence of Hyperpigmentation Following Study Medication Application|The selected treatment area was assessed for hyperpigmentation at baseline (Day 1 pre-dose), Day 57, and at each poststudy followup visit as warranted. If any pigmentation was present, the significance and extent of pigmentation and scarring was recorded. At all timepoints, pigmentation evaluations were performed by a board certified Dermatologist (or equivalent)|Day 57|One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.||participants|||Number
767865|NCT00700063|Primary|Incidence of Hyperpigmentation Following Study Medication Application|The selected treatment area was assessed for hyperpigmentation at baseline (Day 1 pre-dose), Day 57, and at each poststudy followup visit as warranted.|Baseline|One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.||participants|||Number
767866|NCT00700063|Primary|Incidence Rate and Severity of LSRs Following Study Medication Application|"The treatment area was assessed at baseline, Day 1 (pre-dose), and at each subsequent study visit for the presence and grade (0 to 4) of the following LSRs: erythema; flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration. A composite LSR score (0 to 24), reflecting the sum of each individual LSR grade, was calculated for each patient at each visit.
The actual value and change from baseline in the composite LSR score were also summarized."|Day 57|One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.||units on a scale||Standard Deviation|Mean
767871|NCT00700102|Secondary|Response Rate: Participants With Response Status Based on RECIST Criteria|"Response Evaluation Criteria In Solid Tumors (RECIST) is a set of published rules that define when tumors in cancer patients improve (respond), stay the same (stabilize), or worsen (progress) during treatment."|within 6.5 years|Participants with measurable disease||percentage of participants||95% Confidence Interval|Number
773375|NCT00738023|Secondary|Changes in Systolic Blood Pressure During Saline Infusions|Systolic blood pressure change from baseline during an 48-hour normal saline infusion in obese diabetic subjects|48 hours|||mmHg||Standard Error|Mean
767872|NCT00700102|Secondary|Response Rate: Percentage of Participants With Best Overall Response, Defined as Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST Criteria||within 6.5 years|Participants with measurable disease||percentage of participants||95% Confidence Interval|Number
767873|NCT00700102|Secondary|Progression Free Survival: Time to Event||within 6.5 years|Unstratified intention to treat population||Months||Full Range|Median
767874|NCT00700102|Secondary|Participants With Progression Free Survival Event||within 6.5 years|Unstratified intention to treat population||participants|||Number
767875|NCT00700102|Secondary|Overall Survival: Months From Time of First Line Therapy||within approximately 9.6 years|||months||95% Confidence Interval|Median
767876|NCT00700102|Primary|Overall Survival: Time From Randomization to Death From Any Cause||within 6.5 years|Intention to treat||months||95% Confidence Interval|Median
767877|NCT00700115|Primary|Plasma Viral Loads (HIV-1 RNA PCR)|Percentage subjects with undetectable Plasma viral loads|baseline to week 48|||percentage of subjects||95% Confidence Interval|Number
767878|NCT00700115|Secondary|To Compare Plasma Triglyceride Levels at 48 Weeks Between LPV/r + RAL and Standard HAART Treated Subjects||48 weeks|intention to treat||mg/dL||Standard Error|Mean
767879|NCT00700141|Secondary|Pharmacoeconomic Benefits as Assessed by the Surgeon|Question: What benefits resulted from the application of TachoSil® during this operation? (different categories to be answered with yes/no)|peri- and post-surgery until hospital discharge|"All 482 patients included and treated with TachoSil®, missing values not imputed.
Multiple answers possible."||participants|||Number
767880|NCT00700141|Primary|Assessment of TachoSil® by the Surgeon With Respect to Handling, Utility and Satisfaction in the Operation, Documented Using 10 Point Numerical Rating Scales|Handling (1= very good to 10= very poor) Satisfaction (1= very satisfied to 10= totally unsatisfied) Utility (1= very useful to 10= completely useless)|after surgery|"All 482 patients included and treated with TachoSil® [= Intention to Treat population (ITT)], missing values not imputed.
For one patient missing information in all three scales (Handling, Utility and Satisfaction in the Operation)"||Units on a scale||Standard Deviation|Mean
767881|NCT00700180|Secondary|Overall Survival - Time to Event|Overall survival was defined as the time between randomization and death due to any cause. Participants without an event were censored at the last time they were known to be alive. Overall Survival was estimated using the Kaplan-Meier method.|Baseline, weekly to death due to any cause, or to end of study|ITT Population.||months||95% Confidence Interval|Median
767882|NCT00700180|Secondary|Overall Survival - Percentage of Participants With an Event|Overall survival was defined as the time between randomization and death due to any cause. Participants without an event were censored at the last time they were known to be alive. Overall Survival was estimated using the Kaplan-Meier method.|Baseline, weekly to 28 days after last dose of study treatment, every 8 weeks thereafter to death due to any cause|ITT population.||percentage of participants|||Number
767883|NCT00700180|Secondary|Duration of Response - Time to Event|The median time, in months, from the first documentation of objective tumor response (CR or PR) to objective tumor progression or death due to any cause. Participants without an event (documented progression or death) were censored at the date of last follow-up for progression. Duration of response was only calculated for participants who had a confirmed objective tumor response (CR or PR). Median Duration of Response was estimated using the Kaplan-Meier method.|Baseline, Day 21 of Cycles 2, 4, and 6 (Bv + chemo), Day 21 of Cycles 7, 8, 9, and 10 (Bv), Day 21 of every other cycle (Bv), and at disease progression.|ITT population: only participants with an objective tumor response (CR or PR) were included in the analysis.||months||95% Confidence Interval|Median
767884|NCT00700180|Secondary|Duration of Response - Percentage of Participants With an Event|Duration of response is defined as time in months from the first documentation of objective tumor response (CR or PR) to objective tumor progression or death due to any cause. Participants without an event (documented progression or death) were censored at the date of last follow-up for progression. Duration of response was only calculated for participants who had a confirmed objective tumor response (CR or PR).|Baseline, Day 21 of Cycles 2, 4, and 6, Day 21 of Cycles 7, 8, 9, and 10, Day 21 of every other cycle, and at disease progression|ITT population; only participants with an objective tumor response (CR or PR) were included in the analysis.||percentage of participants|||Number
767885|NCT00700180|Secondary|Percentage of Participants With Measurable Disease at Baseline Who Achieved CR, PR, or Stable Disease (SD) for at Least 6 Weeks|Percentage of participants with measurable disease at baseline who on assessment achieved CR, PR, or SD according to RECIST. Per RECIST v1.0: CR defined as disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR was defined as ≥30% decrease under baseline of the sum of the LD of all target lesions. No unequivocal progression of non-target disease. No new lesions. SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD since start of treatment. Complete and partial responses must have been confirmed no less than 4 weeks after the criteria for response were first met. For participants with SD, follow-up assessments must have met the SD criteria at least once after study entry at a minimum interval of 6 weeks.|Baseline, Day 21 of Cycles 2, 4, and 6, Day 21 of Cycles 7, 8, 9, and 10, Day 21 of every other cycle, and at disease progression|ITT Population||percentage of participants||95% Confidence Interval|Number
767886|NCT00700180|Secondary|Percentage of Participants With Objective Response|Percentage of participants with CR or PR according to RECIST criteria. Per RECIST v1.0: CR defined as disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR was defined as ≥30% decrease under baseline of the sum of the LD of all target lesions. No unequivocal progression of non-target disease. No new lesions. Complete and partial responses were confirmed no less than 4 weeks after the criteria for response were first met.|Baseline, Day 21 of Cycles 2, 4, and 6, Day 21 of Cycles 7, 8, 9, and 10, Day 21 of every other cycle, and at disease progression|ITT Population. Data for 12 participants (3 at 7.5 mg and 9 at 15 mg) were excluded for reasons including but not limited to: no study treatment (ST), no postbaseline tumor assessment (TA), non-protocol defined antineoplastic therapy before first TA, first TA >70 days after last dose of last ST, last TA less than (<) 42 days from start of therapy.||percentage of participants||95% Confidence Interval|Number
767904|NCT00700375|Primary|Occurrence of Contrast-induced Nephropathy|The primary endpoint was the occurrence of contrast-induced nephropathy, defined as an increase >0.5 mg/dl or >25% in serum Cr concentration within 2 days of the procedure compared to the baseline level.|after procedure and 1,2-3day after procedure|||participants|||Number
767887|NCT00700180|Secondary|Progression-Free Survival - Time to Event|PFS was defined as the time between randomization and disease progression or death due to any cause. Participants without an event were censored at the date of last follow up for progression. Participants with no post baseline follow-up for progression were censored at the day of randomization. Disease progression was evaluated according to the RECIST using CT scans, MRI scans, X-ray, bone scans, or clinical examination. Median PFS was estimated using the Kaplan-Meier method.|Baseline, Day 1, weekly to disease progression|ITT Population.||months||95% Confidence Interval|Median
767888|NCT00700180|Secondary|Progression-Free Survival - Percentage of Participants With an Event|PFS was defined as the time between randomization and progressive disease (PD) according to RECIST criteria, or death due to any cause. PD was defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started. Disease progression was evaluated according to the RECIST using computed tomography (CT) scans, magnetic resonance imaging (MRI) scans, X-ray, bone scans, or clinical examination. Participants without an event were censored at the date of last follow up for progression. Participants with no post baseline follow-up for progression were censored at the day of randomization.|Baseline, Day 1, weekly to disease progression|ITT population.||percentage of participants|||Number
767889|NCT00700180|Primary|Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) by Dichotomized Baseline Plasma Marker Level|Overall response was analyzed and correlated within dichotomized (low- and high-level) baseline plasma biomarker (basic fibroblast growth factor [bFGF], E-selection, intracellular adhesion molecule [ICAM], placental growth factor [PlGF], vascular endothelial growth factor A [VEGF A], vascular endothelial growth factor receptor [VEGFR]-1, and VEGFR-2) subgroups: low-level equals (=) less than or equal to (≤) median baseline level, high-level=greater than (>) median baseline level. Per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.0 CR defined as disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR defined as greater than or equal to (≥)30 percent (%) decrease under baseline of the sum of the longest diameter (LD) of all target lesions. No unequivocal progression of non-target disease; no new lesions. Complete and partial responses must have been confirmed no less than 4 weeks after criteria for response were first met|Baseline, Day 21 of Cycles 2, 4, and 6 (Bv + chemo), Day 21 of Cycles 7, 8, 9, and 10 (Bv), Day 21 of every other cycle (Bv), and at disease progression.|Biomarker Evaluable Protein Plasma (BEP) Population: Participants in the ITT population who started at least 1 dose of bevacizumab and had a non-missing baseline biomarker level determined for at least 1 biomarker. n (number) equals (=) number of participants assessed for the specified biomarker.||percentage of participants|||Number
767890|NCT00700271|Secondary|Percentage of Participants With Controlled Office Mean Seated Systolic Blood Pressure (msSBP)/Mean Seated Diastolic Blood Pressure (msDBP) at Endpoint|At each of the office visits, blood pressure was recorded in the morning between 08.00 and 11.00, before any antihypertensive treatment was taken. The patient remained in a sitting position for 5 minutes; the investigator then took 3 blood pressure and 1 pulse rate reading. The measurements were recorded at 1-2 minute intervals. BP Control is defined as msSBP/msDBP <149/90 mmHg and/or <130/80 mmHg if diabetes or renal insufficiency (RI).|Visit 4 (week 8)|The Intent-to-treat (ITT) population included all patients randomized and treated in the study and for whom two Ambulatory Blood Pressure Monitoring (ABPM) evaluations are available.||Percentage of participants|||Number
767891|NCT00700271|Secondary|Percentage of Participants With Nocturnal Mean Systolic Blood Pressure (SBP)/Diastolic Blood Pressure (DBP) < 120/70 mmHg at Endpoint With Ambulatory Blood Pressure Monitoring|Ambulatory Blood Pressure Monitoring (ABPM) over a 30-hour period was carried out in all patients at two visits during the study, 72 hours before visit 2 (baseline) and visit 4 (week 8). ABPM for visit four began after 12 weeks of treatment and before the last office blood pressure was taken.|Visit 4 (week 8)|The Intent-to-treat (ITT) population included all patients randomized and treated in the study and for whom two Ambulatory Blood Pressure Monitoring (ABPM) evaluations are available.||Percentage of participants|||Number
767892|NCT00700271|Secondary|Percentage of Participants With Diurnal Mean Systolic Blood Pressure (SBP)/Diastolic Blood Pressure (DBP) < 135/85 mmHg at Endpoint With Ambulatory Blood Pressure Monitoring|Ambulatory Blood Pressure Monitoring (ABPM) over a 30-hour period was carried out in all patients at two visits during the study, 72 hours before visit 2 (baseline) and visit 4 (week 8). ABPM for visit four began after 12 weeks of treatment and before the last office blood pressure was taken.|Visit 4 (week 8)|The Intent-to-treat (ITT) population included all patients randomized and treated in the study and for whom two Ambulatory Blood Pressure Monitoring (ABPM) evaluations are available.||Percentage of Participants|||Number
767893|NCT00700271|Secondary|Percentage of Participants With 24-hour Mean Systolic Blood Pressure (SBP)/Diastolic Blood Pressure (DBP) < 125/80 mmHg at Endpoint With Ambulatory Blood Pressure Monitoring|Ambulatory Blood Pressure Monitoring (ABPM) over a 30-hour period was carried out in all patients at two visits during the study, 72 hours before visit 2 (baseline) and visit 4 (week 8). ABPM for visit four began after 12 weeks of treatment and before the last office blood pressure was taken.|Visit 4 (week 8)|The Intent-to-treat (ITT) population included all patients randomized and treated in the study and for whom two Ambulatory Blood Pressure Monitoring (ABPM) evaluations are available.||Percentage of Participants|||Number
767894|NCT00700271|Secondary|Mean Seated Systolic Blood Pressure (msSBP)/Mean Seated Diastolic Blood Pressure (msDBP) Variation Between Week -4 to Week 8 in Office Blood Pressure|At each of the office visits, blood pressure was recorded in the morning between 08.00 and 11.00, before any antihypertensive treatment was taken. The patient remained in a sitting position for five minutes; the investigator then took three blood pressure and one pulse rate reading. The measurements were recorded at 1-2 minute intervals. Covariates included baseline level, country, up-titration + treatment*country and treatment*up-titration interactions in case statistically significant at a 0.10 level.|Screening visit (Week -4, prior to 4-week open-label screening phase) and Week 8 (after 8 weeks of combination therapy)|The Intent-to-treat (ITT) population included all patients randomized and treated in the study and for whom two Ambulatory Blood Pressure Monitoring (ABPM) evaluations are available.||mmHg||Standard Error|Mean
767895|NCT00700271|Secondary|Mean Seated Systolic Blood Pressure (msSBP)/Mean Seated Diastolic Blood Pressure (msDBP) Variation Between Week 0 and Week 8 in Office Blood Pressure|At each of the office visits, blood pressure was recorded in the morning between 08.00 and 11.00, before any antihypertensive treatment was taken. The patient remained in a sitting position for five minutes; the investigator then took three blood pressure and one pulse rate reading. The measurements were recorded at 1-2 minute intervals. Covariates included baseline level, country, up-titration + treatment*country and treatment*up-titration interactions in case statistically significant at a 0.10 level.|Baseline (Week 0, after completion of screening period) and Week 8 (after 8 weeks of combination therapy)|The Intent-to-treat (ITT) population included all patients randomized and treated in the study and for whom two Ambulatory Blood Pressure Monitoring (ABPM) evaluations are available.||mmHg||Standard Error|Least Squares Mean
767896|NCT00700271|Secondary|Absolute Reduction From Baseline in 6-hour Mean Systolic Blood Pressure (SBP)/Diastolic Blood Pressure (DBP) on Ambulatory Blood Pressure Monitoring|Ambulatory Blood Pressure Monitoring (ABPM) over a 30-hour period was carried out in all patients at two visits during the study, 72 hours before visit 2 (baseline) and visit 4 (week 8). ABPM for visit 2 was carried out prior to randomization and the first dose of the amlodipine/valsartan combination study therapy. ABPM for visit four began after 12 weeks of treatment and before the last office blood pressure was taken. Covariates included baseline level, country, up-titration + treatment*country and treatment*up-titration interactions in case statistically significant at a 0.10 level.|Baseline (Week 0, after completion of screening period) and Week 8 (after 8 weeks of combination therapy)|The Intent-to-treat (ITT) population included all patients randomized and treated in the study and for whom two Ambulatory Blood Pressure Monitoring (ABPM) evaluations are available.||mmHg||Standard Error|Least Squares Mean
767897|NCT00700271|Secondary|Absolute Reduction From Baseline in 24-hour Mean Diastolic Blood Pressure (DBP) on Ambulatory Blood Pressure Monitoring|Ambulatory Blood Pressure Monitoring (ABPM) over a 30-hour period was carried out in all patients at two visits during the study, 72 hours before visit 2 (baseline) and visit 4 (week 8). ABPM for visit 2 was carried out prior to randomization and the first dose of the amlodipine/valsartan combination study therapy. ABPM for visit four began after 12 weeks of treatment and before the last office blood pressure was taken. Covariates included baseline level, country, up-titration + treatment*country and treatment*up-titration interactions in case statistically significant at a 0.10 level.|Baseline (Week 0, after completion of screening period) and Week 8 (after 8 weeks of combination therapy)|The Intent-to-treat (ITT) population included all patients randomized and treated in the study and for whom two Ambulatory Blood Pressure Monitoring (ABPM) evaluations are available.||mmHg||Standard Error|Least Squares Mean
767898|NCT00700271|Secondary|Absolute Reduction From Baseline in Nocturnal Mean Systolic Blood Pressure (SBP)/Diastolic Blood Pressure (DBP) on Ambulatory Blood Pressure Monitoring|Ambulatory Blood Pressure Monitoring (ABPM) over a 30-hour period was carried out in all patients at two visits during the study, 72 hours before visit 2 (baseline) and visit 4 (week 8). ABPM for visit 2 was carried out prior to randomization and the first dose of the amlodipine/valsartan combination study therapy. ABPM for visit four began after 12 weeks of treatment and before the last office blood pressure was taken. Covariates included baseline level, country, up-titration + treatment*country and treatment*up-titration interactions in case statistically significant at a 0.10 level.|Baseline (Week 0, after completion of screening period) and Week 8 (after 8 weeks of combination therapy)|The Intent-to-treat (ITT) population included all patients randomized and treated in the study and for whom two Ambulatory Blood Pressure Monitoring (ABPM) evaluations are available.||mmHg||Standard Error|Least Squares Mean
767899|NCT00700271|Secondary|Absolute Reduction From Baseline in Diurnal Mean Systolic Blood Pressure (SBP)/Diastolic Blood Pressure (DBP) on Ambulatory Blood Pressure Monitoring|Ambulatory Blood Pressure Monitoring (ABPM) over a 30-hour period was carried out in all patients at two visits during the study, 72 hours before visit 2 (baseline) and visit 4 (week 8). ABPM for visit 2 was carried out prior to randomization and the first dose of the amlodipine/valsartan combination study therapy. ABPM for visit four began after 12 weeks of treatment and before the last office blood pressure was taken. Covariates included baseline level, country, up-titration + treatment*country and treatment*up-titration interactions in case statistically significant at a 0.10 level.|Baseline (Week 0, after completion of screening period) and Week 8 (after 8 weeks of combination therapy)|The Intent-to-treat (ITT) population included all patients randomized and treated in the study and for whom two Ambulatory Blood Pressure Monitoring (ABPM) evaluations are available.||mmHg||Standard Error|Least Squares Mean
767900|NCT00700271|Primary|Absolute Reduction From Baseline in 24-hour Mean Systolic Blood Pressure (SBP) on Ambulatory Blood Pressure Monitoring|Ambulatory Blood Pressure Monitoring (ABPM) over a 30-hour period was carried out in all patients at two visits during the study, 72 hours before visit 2 (baseline) and visit 4 (week 8). ABPM for visit 2 was carried out prior to randomization and the first dose of the amlodipine/valsartan combination study therapy. ABPM for visit four began after 12 weeks of treatment and before the last office blood pressure was taken. Covariates included baseline level, country, up-titration + treatment*country and treatment*up-titration interactions in case statistically significant at a 0.10 level.|Baseline (Week 0, after completion of screening period) and Week 8 (after 8 weeks of combination therapy)|The Intent-to-treat (ITT) population included all patients randomized and treated in the study and for whom two Ambulatory Blood Pressure Monitoring (ABPM) evaluations are available.||mmHg||Standard Error|Least Squares Mean
767901|NCT00700310|Secondary|Percent Change in the 28-day Complex Partial Plus Secondarily Generalized Seizure Frequency From Baseline to the End of the Double-blind Phase (Titration and Maintenance Phases)|Percent Change in the Seizure frequency per 28 days was derived from the information recorded in the subject diaries.|Baseline (Pre-randomization) through Week 19|Full ITT Analysis Set||Percent Change||Full Range|Median
767902|NCT00700310|Secondary|Responder Rate|The responder rate for the Full ITT Analysis Set from the maintenance LOCF (Last Observation Carried Forward). A responder was a subject who had a 50 percent or greater reduction in seizure frequency per 28 days from the Pre‑randomization phase.|Baseline (Pre-randomization) through Week 19|Full ITT Analysis Set.||Percentage of Participants|||Number
767903|NCT00700310|Primary|Percent Change in the 28-day Seizure Frequency From Baseline to the End of the Double-blind Phase (Titration and Maintenance Phases)|Seizure frequency per 28 days was derived from the information recorded in the subject diaries.|Baseline (Pre-randomization) through Week 19|Full Intent-to-Treat (ITT) Analysis Set - group of subjects who were randomized to study drug, received study drug, and had any seizure frequency data during the Double-blind Phase.||Percent Change||Full Range|Median
767905|NCT00700401|Secondary|Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48|Biochemistry parameters included alanine transaminase (ALT), aspartate transaminase (AST), gamma-glutamyl transpeptidase (Gamma-GT),fasting cholesterol, blood glucose, insulin, total bilirubin, creatinine, triglycerides, homeostatic model assessment score, prothrombin time (PT) and international normalized ratio (INR). The homeostatic model assessment (HOMA) score is a method used to quantify insulin resistance. HOMA score = (fasting glucose in mg/dL × fasting insulin in μIU/mL) / 405. A normal participant can have a HOMA score up to 3. A patient with a score of >3 is definitely insulin resistance. Low HOMA score indicate high insulin resistance, whereas high HOMA score indicate low insulin resistance.|Baseline, Week 4, Week 12, Week 24 and Week 48|Intention-to-treat (ITT) population included all participants who received at least one dose of study drug. Data of participants available at the assessment time point were included in the analysis. 'n' is number of participants analyzed at the specified weeks.||Percent change||Standard Error|Mean
767906|NCT00700401|Secondary|Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48|Hematology parameters included hemoglobin, hematocrit, leukocytes, neutrophils and platelets.|At Baseline (Day 0), Week 2, Week 4, Week 12, Week 24 and Week 48|Intention-to-treat (ITT) population included all participants who received at least one dose of study drug. Data of participants available at the assessment time point were included in the analysis. 'n' is number of participants analyzed at the specified weeks.||Percent change||Standard Error|Mean
767907|NCT00700401|Secondary|Number of Participants With Any Adverse Events and Any Serious Adverse Events|An any adverse events (AEs) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An serious adverse events (SAEs) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.|Up to 48 weeks|Intention-to-treat (ITT) population included all participants who received at least one dose of study drug.||participants|||Number
767908|NCT00700401|Secondary|Percentage of Participants With Positive Predictive Value|Positive predictive value is defined as participants with RVR who did not achieve SVR.|At Week 48|Intention-to-treat (ITT) population included all participants who received at least one dose of study drug. Data of participants available at the assessment time point were included in the analysis.||percentage of participants||95% Confidence Interval|Number
767909|NCT00700401|Secondary|Percentage of Participants With Virological Relapse|Virological relapse is defined as participants with virological response (undetectable HCV RNA) but did not achieve SVR.|At week 48|Intention-to-treat (ITT) population included all participants who received at least one dose of study drug.||Percentage of participants||95% Confidence Interval|Number
767910|NCT00700401|Secondary|Percentage of Participants With Virological Response at Week 24|Virological response is defined as participants with undetectable HCV RNA after the last dose of study drug (Week 24).|At Week 24|Intention-to-treat (ITT) population included all participants who received at least one dose of study drug.||Percentage of participants||95% Confidence Interval|Number
767911|NCT00700401|Secondary|Percentage of Participants With Rapid Virological Response at Week 4|Rapid Virological Response (RVR) is defined as participants with) undetectable HCV RNA at 4 weeks after initiation of the treatment period. The detection limit of HCV RNA was 15 IU/mL by qualitative PCR.|At Week 4|Intention-to-treat (ITT) population included all participants who received at least one dose of study drug.||Percentage of participants||95% Confidence Interval|Number
767912|NCT00700401|Primary|Percentage of Participants With Sustained Virological Response at Week 48|Sustained Virological Response (SVR) is defined as participants with undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) at 24 weeks after the last dose of study drug. The detection limit of HCV RNA was 15 international units (IU) per milliliter (mL) by qualitative polymerase chain reaction (PCR).|At Week 48|Intention-to-treat (ITT) population included all participants who received at least one dose of study drug.||Percentage of participants||95% Confidence Interval|Number
767913|NCT00700427|Secondary|Change From Baseline in European Quality of Life (EuroQoL) Questionnaire-5 Dimensions (EQ-5D) Index Score From Week 24 to Week 49|The EQ-5D is a Self-reported, 5-item scale to assess health utility (mobility, self-care, usual activities, pain and discomfort, and depression/anxiety). Scoring is on a 3-point scale (1=no health problems, 2=some or moderate problems, 3=major health problems). A preference value Index score is calculated using societal preference developed from a general population-based valuation studies. Index score ranges: United Kingdom (UK): -0.59 to 1.0, United States (US): -0.11 to 1.0, where 1 represents best possible health and 0 represents dead, with <0 interpreted as a health state “worse than dead.” A Quality of Life Health State Score visual analog scale (VAS) was assessed, scores range from 0 to 100. Higher scores indicate better health state. Least Square (LS) Mean values were adjusted for treatment, pooled Investigator, baseline.|Baseline (Week 24), Week 49|Participants with a non-missing baseline and at least 1 post-baseline EQ-5D Index Score or VAS score within each group, Last Observation Carried Forward (LOCF) were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
767914|NCT00700427|Secondary|Change From Baseline in the Behavior Rating Inventory of Executive Function-Adult Version:Informant Report (BRIEF-A:Informant) Global Executive Composite (GEC) Index Score From Week 24 to Week 49|BRIEF-A:Informant is a 75-item third-party observer’s view of the participants’ executive functions/self-regulation in their everyday environment. Items include: Inhibit, Shift, Emotional Control, Self Monitor, Initiate, Working Memory, Plan/Organize, Task Monitor, and Organization of Materials. Behavior is rated on a 3-point scale: 1 (behavior is never observed) to 3 (behavior is often observed). GEC Index Score is a subscore of the 75-item BRIEF-A score, reflects overall functioning and was calculated based on 70 items. Total scores range: 70-210. Lower scores = less perceived impairment. Least Squares (LS) Mean values were adjusted for treatment, pooled Investigator, and baseline.|Baseline (Week 24), Week 49|Participants with a non-missing baseline and at least 1 post-baseline BRIEF-A:Informant result within each group, Last Observation Carried Forward (LOCF) were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
767972|NCT00700817|Secondary|Mean Change in Systolic Blood Pressure (SBP) From Week 52 to Week 78|Mean change in systolic blood pressure (SBP) from Week 52 to Week 78.|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)||mmHg||Standard Deviation|Mean
767915|NCT00700427|Secondary|Change From Baseline in the Behavior Rating Inventory of Executive Function-Adult Version: Self Report (BRIEF-A:Self Report) Global Executive Composite (GEC) Index Score From Week 24 to Week 49|The BRIEF-A:Self Report is a 75-item self-reported measure captures adults' views of their own executive functions/self-regulation in their everyday environment. Items include: Inhibit, Shift, Emotional Control, Self Monitor, Initiate, Working Memory, Plan/Organize, Task Monitor, and Organization of Materials. Behavior is rated on a 3-point scale: 1 (behavior is never observed) to 3 (behavior is often observed). GEC Index Score is a subscore of the 75-item BRIEF-A score, reflects overall functioning and was calculated based on 70 items. Total scores range: 70-210. Lower scores = less perceived impairment. Least Squares (LS) Mean values were adjusted for treatment, pooled Investigator, and baseline.|Baseline (Week 24), Week 49|Participants with a non-missing baseline and at least 1 post-baseline BRIEF-A:Self Report result within each group, Last Observation Carried Forward (LOCF) were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
767916|NCT00700427|Secondary|Change From Baseline in Conner's Adult ADHD Rating Scale-Self Rated (CARRS-S:SV) Total ADHD Symptom Score From Week 24 to Week 49|CAARS-S:SV is a 30-item participant completed scale containing 3 subscales: inattention (9 items), hyperactivity/impulsivity (9 items), ADHD Index (12 items). 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Inattention and hyperactivity subscales range from 0-27; ADHD index subscale range is 0-36 with higher scores indicating more impaired participants. Total ADHD symptoms score=sum of the inattention and hyperactivity/impulsivity subscales; range: 0-54 with higher scores indicating more impaired participants. Least Squares (LS) Mean values adjusted for treatment, pooled Investigator, and baseline.|Baseline (Week 24), Week 49|Participants with a non-missing baseline and at least 1 post-baseline CAARS-S:SV result within each treatment group, Last Observation Carried Forward (LOCF).||units on a scale||Standard Error|Least Squares Mean
767917|NCT00700427|Secondary|Change From Baseline in Conner's Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (Observer Rated [CAARS-O:SV]) Total ADHD Symptom Score From Week 24 to Week 49|The CAARS-O:SV is a 30-item observer (typically a significant other or close friend) completed scale containing 3 subscales: inattention (9 items), hyperactivity/impulsivity (9 items), and ADHD Index (12 items). Each item is scored 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Inattention and hyperactivity subscales range from 0-27; ADHD index subscale range is 0-36 with higher scores indicating more impaired participants. Total ADHD symptoms score=sum of the inattention and hyperactivity/impulsivity subscales, ranging from 0-54, with higher scores indicating more impaired participants. Least Squares (LS) Mean values adjusted for treatment, pooled Investigator, and baseline.|Baseline (Week 24), Week 49|Participants with a non-missing baseline and at least 1 post-baseline CAARS-O:SV result within each group, Last Observation Carried Forward (LOCF) were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
767918|NCT00700427|Secondary|Change From Baseline in the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life (AAQoL) Scale From Week 24 to Week 49|The AAQoL is a self-reported, 29-item scale assessing functional impairments in adults with ADHD. Each item is rated on a 5-point Likert scale; range: 1 (Not at all/ Never) to 5 (Extremely/Very Often). 5-domains of scale include: work functioning, family relationships, social functioning, activities of daily living (driving, managing finances), and psychological adaptation (life satisfaction, self-esteem). These scores are transformed to a 0-100 point scale (1=0; 2=25; 3=50; 4=75; 5=100), and then the item scores are summed and divided by item count to generate overall scores. The overall scores have the same total range of scores of 0-100, with higher scores indicating better quality of life. Least Squares (LS) Mean values were adjusted for baseline AAQoL score and Investigator/site.|Baseline (Week 24), Week 49|All randomized participants with a baseline and at least 1 post-baseline AAQoL score were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
767919|NCT00700427|Secondary|Number of Days Until Relapse|"Relapse was defined as 2 consecutive visits with a CGI-ADHD-S score ≥4 points and a return to ≥80% of participant's baseline (Visit 2) CAARS-Inv:SV Total ADHD Symptom Score (SS). If the participant showed evidence of a return of symptoms at a single visit that met severity criteria described above, and because of worsening symptoms, was unwilling to remain in the study or did not return for a second visit, the participant was also considered to have relapsed.
CAARS-Inv:SV is a 30-item scale (3 subscales): Inattention, Hyperactivity/Impulsivity (9 items each), ADHD Index (12 items). Each item is scored 0 (0=not at all/never) to 3 (very much/very frequently). Total ADHD SS=inattention+hyperactivity/impulsivity (range: 0-54). Higher score=more impairment. CGI-ADHD-S measures participant's overall severity of ADHD symptoms and scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants)."|Baseline (Week 24) up to Week 49|Analyses were conducted using all randomized participants in the Double-Blind Period (Study Period 3B).||days||Standard Deviation|Mean
767920|NCT00700427|Primary|Percentage of Participants Who Maintain a Satisfactory Response During the Double-Blind Maintenance/Randomized Withdrawal Period|Conners' Adult ADHD Rating Scale-Investigator Rated:Screening Version (CAARS-Inv:SV); 30-item scale (3 subscales): inattention, hyperactivity/impulsivity (9 items each), ADHD Index (12 items). Each item is scored 0 (not at all/never) to 3 (very much/very frequently). Total ADHD symptoms score (SS)=inattention+hyperactivity/impulsivity (range:0-54). Higher score=more impairment. Clinical Global Impressions-ADHD-Severity (CGI-ADHD-S) measures participant's overall severity of ADHD symptoms and scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Maintenance of response during the randomized withdrawal phase was a reduction of ≥30% in the baseline CAARS-Inv:SV Total ADHD SS and a CGI-ADHD-S score ≤3. Participants had to continuously meet the response criteria, except for 1 excursion after assessment at Week 24 through Week 37 and 1 other excursion after assessment at Week 37 through Week 49. Excursions were not permitted at 2 consecutive visits.|Baseline (Week 24) up to Week 49|Primary outcome measure analysis was conducted using all randomized participants in the Double-Blind Maintenance/Randomized Withdrawal Period (Study Period 3B).||percentage of responders|||Number
767921|NCT00700440|Secondary|1,3,5 Year Loco-regional Control Rate, 1 Year Progression-free Survival and Metastasis-free Survival, 3 and 5 Year Overall Survival||5 year||||||
767973|NCT00700817|Secondary|Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 52|Calculated as an estimate of the mean change from baseline in systolic blood pressure (SBP) at Week 52.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||mmHg||Standard Error|Least Squares Mean
767922|NCT00700440|Primary|3 Month Loco-regional Control After Cetuximab With Concurrent Chemoradiotherapy|"The response status (Complete Response + Partial Response) was evaluated according to RECIST (Response Evaluation Criteria in Solid Tumors) criteria. Complete response was defined as disappearance of all target lesions, and Partial response was defined as at least a 30% reduction in the sum of the longest diameter of target lesions, taking as reference the baseline study.
Adverse events of this combined modality treatment were graded according to CTCAE (Common Terminology Criteria for Adverse Events) v3.0 criteria."|3 months|||participants with loco-regional control|||Number
767923|NCT00700570|Secondary|Percentage of Participants by Best Overall Tumor Response According to RECIST Version 1.1|Objective tumor response was assessed using RECIST version 1.1. CR was defined as the disappearance of all target lesions, and PR was defined as a ≥30% decrease in the sum of longest diameters compared to Baseline. Response was to be confirmed at a minimum of 4 weeks after the first documented response. Stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, as well as no new target lesions. Disease progression or PD was defined as a ≥20% increase in the sum of longest diameters of target lesions, taking as reference the smallest sum obtained at previous tumor assessment, or the appearance of any new lesions. Non-evaluability for tumor assessment was also documented when applicable. The percentage of participants with each level of response was calculated as [number of participants meeting the respective criteria divided by the number analyzed] multiplied by 100.|Up to approximately 3 years (at Baseline, end of Cycle 5, time of surgery, within 4 weeks of EOT, and at least 4 weeks after initial response)|ITT Population.||percentage of participants|||Number
767924|NCT00700570|Secondary|Percentage of Participants With a Best Overall Tumor Response of Complete Response (CR) or PR According to RECIST Version 1.1|Objective tumor response was assessed using RECIST version 1.1. CR was defined as the disappearance of all target lesions, and PR was defined as a ≥30% decrease in the sum of longest diameters compared to Baseline. Response was confirmed at a minimum of 4 weeks after the first documented response. The percentage of participants with confirmed CR or PR was calculated as [number of participants meeting the respective criteria divided by the number analyzed] multiplied by 100.|Up to approximately 3 years (at Baseline, end of Cycle 5, time of surgery, within 4 weeks of EOT, and at least 4 weeks after initial response)|ITT Population.||percentage of participants|||Number
767925|NCT00700570|Secondary|Time to Disease Progression|Objective tumor response was assessed using RECIST version 1.1. Disease progression was defined as a ≥20% increase in the sum of longest diameters of target lesions, taking as reference the smallest sum obtained at previous tumor assessment, or the appearance of any new lesions. Time to disease progression was defined as the time from first dose to time of disease progression. Participants without progression were censored at the time of last tumor assessment. Time to disease progression was estimated using Kaplan-Meier analysis and expressed in months.|Up to approximately 3 years (at Baseline, end of Cycle 5, time of surgery, and within 4 weeks of EOT)|ITT Population.||months||95% Confidence Interval|Median
767926|NCT00700570|Secondary|Percentage of Participants With Disease Progression|Objective tumor response was assessed using RECIST version 1.1. Disease progression was defined as a ≥20 percent (%) increase in the sum of longest diameters of target lesions, taking as reference the smallest sum obtained at previous tumor assessment, or the appearance of any new lesions. The percentage of participants with disease progression was calculated as [number of participants meeting the above criteria divided by the number analyzed] multiplied by 100.|Up to approximately 3 years (at Baseline, end of Cycle 5, time of surgery, and within 4 weeks of end of treatment [EOT])|ITT Population.||percentage of participants|||Number
767927|NCT00700570|Primary|Percentage of Participants With Conversion From Unresectable to Resectable Liver Metastases|Participants were assessed via microscopic and macroscopic examination for tumor resectability after completion of 5 cycles of neoadjuvant treatment. Unresectable participants exhibited any of the following criteria: greater than or equal to (≥) 4 liver metastases; location and/or distribution of metastatic disease within the liver considered unsuitable for resection with clear margins; liver involvement precluding resection, in the setting of adequate parenchymal volume for otherwise viable liver function in the immediate postoperative period; and inability to maintain adequate circulation for viable liver function. Participants who had not met any of the above criteria at the end of 5 cycles underwent surgical resection. The percentage of participants with conversion from initially unresectable to resectable liver metastases was calculated as [number of participants eligible for surgical resection divided by the number analyzed] multiplied by 100.|After 5 cycles of neoadjuvant treatment (10 weeks)|ITT Population.||percentage of participants|||Number
767928|NCT00700622|Primary|Change From Baseline in HbA1c to Week 16|Change from Baseline in glycosylated hemoglobin at Week 16|Baseline to Week 16|Intent to Treat with Available Data at Week 16||percentage of total hemoglobin||Standard Error|Least Squares Mean
775452|NCT00756977|Secondary|Hematology Results (%)|Change from Baseline|2 days|Intent to treat population||standard %||Standard Deviation|Mean
767934|NCT00700713|Other Pre-specified|Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra®|Solicited injection-site: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Vomiting, Drowsiness, Anorexia, Irritability, Arthralgia, and Diarrhea. Grade 3 Solicited Injection-site: Pain - Incapacitating, unable to perform usual activities; Erythema and Swelling - ≥2.0 in. Grade 3 Solicited systemic: Fever (Temperature) ->39.0˚C (>102.2˚F); Headache - Prevents daily activities; Vomiting - ≥3 episodes per 24 hours; Drowsiness - Disabling, dozing off or falling asleep while engaged in usual activities; Anorexia - Skips ≥3 meals; Irritability - >3 hours duration; Arthralgia - Unwilling to move due to pain; and Diarrhea - ≥ 5 episodes per 24 hours.|Day 0 up to Day 7 post-vaccination|Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set.||Percentage of participants|||Number
767935|NCT00700713|Other Pre-specified|Geometric Mean Antibody Titers to Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®.|Antibody titers to meningococcal serogroups A, C, Y, and W-135 were measured by serum bactericidal assay using human complement (SBA-HC).|Day 0 (pre-vaccination) and Day 30 post-vaccination|Meningococcal Serogroups A, C, Y, and W-135 Geometric Mean Titers were assessed in the Per-Protocol Analysis Set.||Titers (1/dilutions)||95% Confidence Interval|Geometric Mean
767936|NCT00700713|Primary|Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra®|Antibody titers to meningococcal serogroups A, C, Y, and W-135 were measured by serum bactericidal assay using human complement (SBA-HC). Bactericidal antibody persistence to meningococcal serogroups was defined as as pre-vaccination titers of ≥1:4 and ≥1:8. Booster response to a single Menactra vaccine dose was defined as antibody titers of ≥1:4 and ≥1:8 30 days post-booster vaccination.|Day 0 (pre-vaccination) and Day 30 post-vaccination|Meningococcal serogroups A, C, Y, and W-135 antibody persistence and booster response were assessed in the Per-Protocol Analysis Set.||Percentage of participants|||Number
767937|NCT00700739|Secondary|Device Related Adverse Events|The proportion of subjects with device related adverse events as reported throughout the duration of the study.|Intra-operatively to 24 months post-operative|||Percentage of subjects|||Number
767938|NCT00700739|Secondary|Cervical Range of Motion Measured Radiographically at 6 Months|Cervical range of motion measures the angle, in degrees, between the inferior endplate of C2 to the inferior endplate of C7 on flexion-extension radiographs.|6 months|Only 2 subjects in the cTDR and 2 subjects in the ACDF treatment groups were available for this outcome measure.||degrees||Standard Deviation|Mean
767939|NCT00700739|Secondary|Foraminal Height Measured Radiographically at 24 Months|Foraminal height is the maximum vertical distance, measured in millimeters (mm), between the inferior surface of the superior pedicle and superior surface of the inferior pedicle. These measurements are obtained via magnetic resonance imaging (MRI).|24 months|The study was terminated prior to 24 months therefore there are no results for this endpoint.|||||
767940|NCT00700739|Secondary|Maintenance of Disc Height Measured Radiographically at 6 Months|Maintenance of disc height is measured at the index and adjacent levels to determine the effect of the treatment on restoration or maintenance of the disc height. Initial post-operative disc height is compared with subsequent post-operative visits (i.e. 6 months) to evaluate the maintenance of disc height. The height is measured in millimeters (mm).|6 months|Only 2 subjects in the cTDR and 1 subject in the ACDF treatment groups were available for this outcome measure. There were 2 ACDF subjects at this endpoint, however one subject was missing the flexion extension rotation radiographic view therefore could not be included in the analysis.||mm||Standard Deviation|Mean
767941|NCT00700739|Secondary|Adjacent Level Degeneration Measured Radiographically at 24 Months|Adjacent Level Degeneration is evaluated using a point system that assigns numerical scores to severity of Height Loss, Anterior Osteophytes, and Endplate Sclerosis; and then grades into one of the following five categories: None, Mild, Moderate, Severe, or NA.|24 months|Study was terminated prior to 24 months therefore there are no results for this endpoint.|||||
767942|NCT00700739|Secondary|Sagittal Angulation, Also Known as Global Lordosis, Measured Radiographically at 6 Months|Sagittal Angulation is a measure of the angle formed between the inferior endplate of the C2 vertebrae and the corresponding inferior endplate of vertebrae C7 of the spine, measured in degrees, from a side (sagittal) view.|6 months|Only 2 subjects in the Cervical Total Disc Replacement (cTDR) and 1 subject in the ACDF treatment groups were available for this outcome measure. There were 2 ACDF subjects at this endpoint, however one subject was missing the flexion extension rotation radiographic view therefore could not be included in the analysis.||degrees||Standard Deviation|Mean
767943|NCT00700739|Secondary|Work Status Assessed at 12 Months|The proportion of subjects with unrestricted work status (compared to subjects not working or with restricted work status) is reported at the 12 month follow-up interval.|12 months|Due to withdrawals and incomplete or unavailable assessments, 18 subjects in the CTDR and 12 subjects in the ACDF treatment groups were available for this outcome.||Percentage of Subjects|||Number
767944|NCT00700739|Secondary|Change in Function Assessed by Neck Disability Index Improvement From Pre-treatment to 12 Months|The neck disability index (NDI) is a validated, disease specific, self-administrated questionnaire for assessing pain intensity and function in patients with neck pain on a scale from 0 to 100. A lower score is a better result (i.e. less severe pain and/or better function). The proportion of patients with an improved score (lower) of 15 points or more was the analysis variable.|12 months|Due to withdrawals and incomplete or unavailable assessments, 18 subjects in the CTDR and 11 subjects in the ACDF treatment groups were available for this outcome.||Percentage of Subjects|||Number
767945|NCT00700739|Secondary|Change in Physical Component Summary Quality of Life Measure Assessed by Short Form SF-36 From Pre-treatment to 12 Months|The 36-item Short Form Health Survey (SF-36) is a patient reported outcome survey that evaluates functional health and well-being. The survey is converted into 2 summary measures that are scored from 0 to 100 (where 100 indicates the highest level of health) - the Physical Component Score (PCS-36) and Mental Component Score (MCS-36)|12 months|Due to withdrawals and incomplete or unavailable assessments, 16 subjects in the CTDR and 10 subjects in the ACDF treatment groups were available for this outcome.||units on a scale||Standard Deviation|Mean
767974|NCT00700817|Secondary|Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 26|Calculated as an estimate of the mean change from baseline in Systolic Blood Pressure (SBP) at Week 26|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||mmHg||Standard Error|Least Squares Mean
767946|NCT00700739|Secondary|Change in Mental Component Summary Quality of Life Measure Assessed by Short Form SF-36 From Pre-treatment to 12 Months|The 36-item Short Form Health Survey (SF-36) is a patient reported outcome survey that evaluates functional health and well-being. The survey is converted into 2 summary measures that are scored from 0 to 100 (where 100 indicates the highest level of health) - the Physical Component Score (PCS-36) and Mental Component Score (MCS-36)|12 months|Due to withdrawals and incomplete or unavailable assessments, 16 subjects in the CTDR and 10 subjects in the ACDF treatment groups were available for this outcome.||units on a scale||Standard Deviation|Mean
767947|NCT00700739|Secondary|Change in Visual Analogue Scale (VAS) Left Shoulder Pain From Pre-treatment to 12 Months.|The visual analogue scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line (that is approximately 10 cm long) with 'No Pain' (score of 0 = 0 cm) listed on the left and 'Very severe pain' (score of 10 = 10 cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their left shoulder.|12 Months|Due to withdrawals and incomplete or unavailable assessments, 17 subjects in the CTDR and 11 subjects in the ACDF treatment groups were available for this outcome.||units on a scale||Standard Deviation|Mean
767948|NCT00700739|Secondary|Change in Visual Analogue Scale (VAS) Right Shoulder Pain From Pre-treatment to 12 Months.|The visual analogue scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line (that is approximately 10 cm long) with 'No Pain' (score of 0 = 0 cm) listed on the left and 'Very severe pain' (score of 100 = 10 cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their right shoulder.|12 Months|Due to withdrawals and incomplete or unavailable assessments, 18 subjects in the CTDR and 11 subjects in the ACDF treatment groups were available for this outcome.||units on a scale||Standard Deviation|Mean
767949|NCT00700739|Secondary|Change in Visual Analogue Scale (VAS) Right Arm Pain From Pre-treatment to 12 Months.|The visual analogue scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line (that is approximately 10 cm long) with 'No Pain' (score of 0= 0 cm) listed on the left and 'Very severe pain' (score of 100= 10 cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their right arm.|12 Months|Due to withdrawals and incomplete or unavailable assessments, 18 subjects in the CTDR and 11 subjects in the ACDF treatment groups were available for this outcome.||units on a scale||Standard Deviation|Mean
767950|NCT00700739|Secondary|Change in Visual Analogue Scale (VAS) Left Arm Pain From Pre-treatment to 12 Months.|The visual analogue scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line (that is approximately 10 cm long) with 'No Pain' (score of 0 = 0 cm) listed on the left and 'Very severe pain' (score of 100 = 10 cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their left arm.|12 Months|Due to withdrawals and incomplete or unavailable assessments, 18 subjects in the CTDR and 11 subjects in the ACDF treatment groups were available for this outcome.||units on a scale||Standard Deviation|Mean
767951|NCT00700739|Secondary|Change in Visual Analogue Scale (VAS) Neck Pain From Pre-treatment to 12 Months|The visual analogue scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line (that is approximately 10 cm long) with 'No Pain' (score of 0 = 0 cm) listed on the left and 'Very severe pain' (score of 100 = 10 cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their neck.|12 months|Due to withdrawals and incomplete or unavailable assessments, 18 subjects in the CTDR and 11 subjects in the ACDF treatment groups were available for this outcome.||units on a scale||Standard Deviation|Mean
767952|NCT00700739|Primary|Overall Patient Success|Overall success was a composite endpoint determined by the following clinical outcome measures: 1. Neck Disability Index ≥ 15-point improvement from baseline to 12 months post-operative, 2. No new clinically significant permanent abnormalities in neurological function (i.e. motor strength, nerve root tension signs, sensory and reflex signs) from baseline to 12 months post-operative, 3. No subsequent secondary surgical interventions (SSI) at the index level, and 4. No device-related serious events (dSAE) from intra-operative through 12-months post-operative. Please note that these time periods were intended to be from baseline to 24 months post-operative, but since the study was terminated early the 12 month time periods were utilized.|12 months|Overall Patient Success is composed of several outcome measures, some of which require a valid pre-operative and 12-month post-operative score. Due to withdrawals and incomplete or unavailable assessments, 18 subjects in the CTDR and 11 subjects in the ACDF treatment groups were available for the Overall Patient Success calculation.||Percentage of subjects|||Number
767953|NCT00700752|Primary|Patient-reported Comfort at at the Manufacturer's Recommended Lens Replacement Timeframe of 2-weeks (Senofilcon A) or 4-weeks (Balafilcon A).|Subjective rating of overall comfort using a 0 through 5 scale. 0=n/a, 1=poor, 2=fair, 3=good, 4=very good, 5=excellent. Scores from 2-week and 4-week visits were combined for final values.|after 4 weeks of lens wear|||Units on a scale||Standard Error|Least Squares Mean
767954|NCT00700804|Primary|Calcium Absorption|Retention of Calcium-47 was monitored for 28 days by whole body scintillation counting. The percentage of Calcium-47 absorbed was estimated from the y-intercept of the linear portion of a semilogarithmic retention plot of percent Calcium-47 retained vs time|17 weeks|Only participants which completed both protein diet periods were included in the statistical analysis||percentage of Calcium absorbed||Standard Deviation|Mean
767955|NCT00700804|Secondary|Serum Insulin-like Growth Factor 1 (IGF-1)||7 weeks|||nanomoles per liter (nmols/L)||Standard Error|Geometric Mean
767956|NCT00700817|Secondary|Hypoglycaamic Episodes, Weeks 52-78|Number of hypoglycaemic episodes from Week 52 to Week 78, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|Week 52-78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)||episodes|||Number
767957|NCT00700817|Secondary|Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-78|Number of hypoglycaemic episodes from Week 0 to Week 78, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|Weeks 0-78|The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products. An outlier subject from the lira 1.8 mg+met group, who experienced 23 minor hypoglycaemic episodes was excluded from this analysis.||episodes|||Number
767958|NCT00700817|Secondary|Hypoglyceamic Episodes, Weeks 0-78|Number of hypoglycaemic episodes from Week 0 to Week 78, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|Weeks 0-78|The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.||episodes|||Number
767959|NCT00700817|Secondary|Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-52|Number of hypoglycaemic episodes from Week 0 to Week 52, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|Weeks 0-52|The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products. An outlier subject from the lira 1.8 mg+met group, who experienced 23 minor hypoglycaemic episodes was excluded from this analysis.||episodes|||Number
767960|NCT00700817|Secondary|Hypoglyceamic Episodes, Weeks 0-52|Number of hypoglycaemic episodes from Week 0 to Week 52, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|Weeks 0-52|The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.||episodes|||Number
767961|NCT00700817|Secondary|Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26|Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|Weeks 0-26|The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products. An outlier subject from the lira 1.8 mg+met group, who experienced 21 minor hypoglycaemic episodes was excluded from this analysis.||episodes|||Number
767962|NCT00700817|Secondary|Hypoglyceamic Episodes, Weeks 0-26|Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|Weeks 0-26|The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.||episodes|||Number
767963|NCT00700817|Secondary|Mean Change in Overall Treatment Satisfaction (OTS) From Week 52 to Week 78|The Overall Treatment Satisfaction is a sum of 6 items from the Diabetes Treatment Satisfaction Questionnaire, which is a self-assessment of treatment satisfaction. The scale of each sub-item goes from 0 (lowest satisfaction) to 6 (highest satisfaction) and the overall scale of OTS therefore goes from 0 to 36.|Week 52, Week 78|Extension 2 Patient Reported Outcome Analysis Set consisted of all subjects in the Extension 2 FAS, except subjects from countries Serbia, Slovakia and Slovenia||scores on a scale||Standard Deviation|Mean
767964|NCT00700817|Secondary|Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 52|The Overall Treatment Satisfaction is a sum of 6 items from the Diabetes Treatment Satisfaction Questionnaire, which is a self-assessment of treatment satisfaction. The scale of each sub-item goes from 0 (lowest satisfaction) to 6 (highest satisfaction) and the overall scale of OTS therefore goes from 0 to 36.|Week 0, Week 52|Patient Reported Outcome Analysis Set consisted of all subjects in the FAS, except subjects from countries Serbia, Slovakia and Slovenia||scores on a scale||Standard Error|Least Squares Mean
767965|NCT00700817|Secondary|Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 26|The Overall Treatment Satisfaction is a sum of 6 items from the Diabetes Treatment Satisfaction Questionnaire, which is a self-assessment of treatment satisfaction. The scale of each sub-item goes from 0 (lowest satisfaction) to 6 (highest satisfaction) and the overall scale of OTS therefore goes from 0 to 36.|Week 0, Week 26|Patient Reported Outcome Analysis Set consisted of all subjects in the FAS, except subjects from countries Serbia, Slovakia and Slovenia||scores on a scale||Standard Error|Least Squares Mean
767966|NCT00700817|Secondary|Mean Change in Pulse From Week 52 to Week 78|Mean change in pulse from Week 52 to Week 78.|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)||beats/minute||Standard Deviation|Mean
767967|NCT00700817|Secondary|Mean Change From Baseline in Pulse at Week 52|Calculated as an estimate of the mean change from baseline in pulse at Week 52.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||mmHg||Standard Error|Least Squares Mean
767968|NCT00700817|Secondary|Mean Change From Baseline in Pulse at Week 26|Calculated as an estimate of the mean change from baseline in pulse at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||beats/minute||Standard Error|Least Squares Mean
767969|NCT00700817|Secondary|Mean Change in Diastolic Blood Pressure (DBP) From Week 52 to Week 78|Mean change in diastolic blood pressure (DBP) from Week 52 to Week 78.|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)||mmHg||Standard Deviation|Mean
767970|NCT00700817|Secondary|Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 52|Calculated as an estimate of the mean change from baseline in diastolic blood pressure (DBP) at Week 52.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||mmHg||Standard Error|Least Squares Mean
767971|NCT00700817|Secondary|Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 26|Calculated as an estimate of the mean change from baseline in diastolic blood pressure (DBP) at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||mmHg||Standard Error|Least Squares Mean
768175|NCT00694473|Secondary|Sensitivity and Specificity of Navigator Threshold Alarms for Hyperglycemia (>240 mg/dl).||72 hours|This measure was not calculated as we did not have sufficient data to calculate sensitivity and inappropriate BG check times to calculate specificity and few trends towards hyperglycemia|||||
767975|NCT00700817|Secondary|Mean Change in Waist Circumference From Week 52 to Week 78|Mean change in Waist Circumference from Week 52 to Week 78.|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)||kg||Standard Deviation|Mean
767976|NCT00700817|Secondary|Mean Change From Baseline in Waist Circumference at Week 52|Calculated as an estimate of the mean change from baseline in Waist Circumference at Week 52.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||participants||Standard Error|Least Squares Mean
767977|NCT00700817|Secondary|Mean Change From Baseline in Waist Circumference at Week 26.|Calculated as an estimate of the mean change from baseline in Waist Circumference at Week 26|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||cm||Standard Error|Least Squares Mean
767978|NCT00700817|Secondary|Mean Change in Waist to Hip Ratio From Week 52 to Week 78|Mean change in Waist to Hip Ratio from Week 52 to Week 78. The measure is assessed as the circumference of the waist divided by the circumference of the hip.|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)||cm/cm||Standard Deviation|Mean
767979|NCT00700817|Secondary|Mean Change From Baseline in Waist to Hip Ratio at Week 52|Calculated as an estimate of the mean change from baseline in Waist to Hip Ratio at Week 52. The measure is assessed as the circumference of the waist divided by the circumference of the hip.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||cm/cm||Standard Error|Least Squares Mean
767980|NCT00700817|Secondary|Mean Change From Baseline in Waist to Hip Ratio at Week 26.|Calculated as an estimate of the mean change from baseline in Waist to Hip Ratio at Week 26. The measure is assessed as the circumference of the waist divided by the circumference of the hip.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||cm/cm||Standard Error|Least Squares Mean
767981|NCT00700817|Secondary|Mean Change From Baseline in Von Willebrand Factor (vWf) at Week 26.|Calculated as an estimate of the mean change from baseline in von Willebrand Factor (vWf) at Week 26. vWf is a blood glycoprotein involved in haemostasis.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||percentage point||Standard Error|Least Squares Mean
767982|NCT00700817|Secondary|Mean Change From Baseline in Tumour Necrosis Factor Alpha (TNF-alpha) at Week 26.|Calculated as an estimate of the mean change from baseline in Tumour Necrosis Factor Alpha (TNF-alpha) at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||pg/mL||Standard Error|Least Squares Mean
767983|NCT00700817|Secondary|Mean Change From Baseline in Adiponectin at Week 26.|Calculated as an estimate of the mean change from baseline in Adiponectin at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||mcg/mL||Standard Error|Least Squares Mean
767984|NCT00700817|Secondary|Mean Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 26.|Calculated as an estimate of the mean change from baseline in N-terminal pro B-type Natriuretic Peptide (NT-proBNP) at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||pmol/L||Standard Error|Least Squares Mean
767985|NCT00700817|Secondary|Mean Change From Baseline in Interleukin-6 (IL-6) at Week 26.|Calculated as an estimate of the mean change from baseline in interleukin-6 (IL-6) at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||pg/mL||Standard Error|Least Squares Mean
767986|NCT00700817|Secondary|Mean Change From Baseline in Plasminogen Activator Inhibitor-1 (PAI-1) at Week 26.|Calculated as an estimate of the mean change from baseline in plasminogen activator inhibitor-1 (PAI-1) at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||U/L||Standard Error|Least Squares Mean
767987|NCT00700817|Secondary|Mean Change From Baseline in Highly Sensitive C-reactive Protein (hsCRP) at Week 26|Calculated as an estimate of the mean change from baseline in highly sensitive C-reactive protein (hsCRP) at week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||mg/L||Standard Error|Least Squares Mean
767988|NCT00700817|Secondary|Mean Change in Apolipoprotein B From Week 52 to Week 78|Mean change in apolipoprotein B (ApoB) from Week 52 to Week 78.|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)||mmol/L||Standard Deviation|Mean
767989|NCT00700817|Secondary|Mean Change From Baseline in Apolipoprotein B at Week 52|Calculated as an estimate of the change from baseline in apolipoprotein B (ApoB) at Week 52.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||g/L||Standard Error|Least Squares Mean
767990|NCT00700817|Secondary|Mean Change From Baseline in Apolipoprotein B at Week 26|Calculated as an estimate of the change from baseline in apolipoprotein B (ApoB) at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||g/L||Standard Error|Least Squares Mean
767991|NCT00700817|Secondary|Mean Change in Free Fatty Acids (FFA) From Week 52 to Week 78|Mean change in free fatty acids (FFA) from Week 52 to Week 78.|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)||mmol/L||Standard Deviation|Mean
771831|NCT00729924|Secondary|Penetration of Raltegravir (RGV) Into Cerebrospinal Fluid (CSF) Based on Single Plasma Timepoint.|This outcome was the ratio of the 4-hour CSF concentration value (ng/mL) to the 4-hour plasma concentration value (ng/mL).|Day 7|||ratio||Inter-Quartile Range|Median
767992|NCT00700817|Secondary|Mean Change From Baseline in Free Fatty Acids (FFA) at Week 52|Calculated as an estimate of the change from baseline in free fatty acids (FFA) at Week 52.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||mmol/L||Standard Error|Least Squares Mean
767993|NCT00700817|Secondary|Mean Change From Baseline in Free Fatty Acids (FFA) at Week 26|Calculated as an estimate of the change from baseline in free fatty acids (FFA) at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||mmol/L||Standard Error|Least Squares Mean
767994|NCT00700817|Secondary|Mean Change in Triglycerides (TG) From Week 52 to Week 78|Mean change in triglycerides (TG) from Week 52 to Week 78.|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)||mmol/L||Standard Deviation|Mean
767995|NCT00700817|Secondary|Mean Change From Baseline in Triglycerides (TG) at Week 52|Calculated as an estimate of the change from baseline in triglycerides (TG) at Week 52.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||mmol/L||Standard Error|Least Squares Mean
767996|NCT00700817|Secondary|Mean Change From Baseline in Triglycerides (TG) at Week 26|Calculated as an estimate of the change from baseline in triglycerides (TG) at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||mmol/L||Standard Error|Least Squares Mean
767997|NCT00700817|Secondary|Mean Change in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52 to Week 78|Mean change in very low-density lipoprotein-cholesterol (VLDL-C) from Week 52 to Week 78.|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)||mmol/L||Standard Deviation|Mean
767998|NCT00700817|Secondary|Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52|Calculated as an estimate of the change from baseline in very low-density lipoprotein-cholesterol (VLDL-C) at Week 52.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||mmol/L||Standard Error|Least Squares Mean
767999|NCT00700817|Secondary|Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 26|Calculated as an estimate of the change from baseline in very low-density lipoprotein-cholesterol (VLDL-C) at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||mmol/L||Standard Error|Least Squares Mean
768000|NCT00700817|Secondary|Mean Change in High-density Lipoprotein-cholesterol (HDL-C) From Week 52 to Week 78|Mean change in high-density lipoprotein-cholesterol (HDL-C) from Week 52 to Week 78.|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)||mmol/L||Standard Deviation|Mean
768001|NCT00700817|Secondary|Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 52|Calculated as an estimate of the mean change from baseline in high-density lipoprotein-cholesterol (HDL-C) at Week 52.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||mmol/L||Standard Error|Least Squares Mean
768002|NCT00700817|Secondary|Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 26|Calculated as an estimate of the mean change from baseline in high-density lipoprotein-cholesterol (HDL-C) at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||mmol/L||Standard Error|Least Squares Mean
768003|NCT00700817|Secondary|Mean Change in Low-density Lipoprotein-cholesterol (LDL-C) From Week 52 to Week 78|Mean change in low-density lipoprotein-cholesterol (LDL-C) from week 52 to Week 78.|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)||mmol/L||Standard Deviation|Mean
768004|NCT00700817|Secondary|Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 52|Calculated as an estimate of the mean change in low-density lipoprotein-cholesterol (LDL-C) at Week 52.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||mmol/L||Standard Error|Least Squares Mean
768005|NCT00700817|Secondary|Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 26|Calculated as an estimate of the mean change in low-density lipoprotein-cholesterol (LDL-C) at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||mmol/L||Standard Error|Least Squares Mean
768006|NCT00700817|Secondary|Mean Change in Total Cholesterol From Week 52 to Week 78|Mean change in total cholesterol from Week 52 to Week 78|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)||mmol/L||Standard Deviation|Mean
768007|NCT00700817|Secondary|Mean Change From Baseline in Total Cholesterol at Week 52|Calculated as an estimate of the mean change from baseline in total cholesterol at Week 52.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||mmol/L||Standard Error|Least Squares Mean
768008|NCT00700817|Secondary|Mean Change From Baseline in Total Cholesterol at Week 26|Calculated as an estimate of the mean change from baseline in total cholesterol at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||mmol/L||Standard Error|Least Squares Mean
768025|NCT00700817|Secondary|Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 52|Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 52|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||percentage of subjects|||Number
768009|NCT00700817|Secondary|Mean Change in Beta-cell Function From Week 52 to Week 78|Mean change in beta-cell function from Week 52 to Week 78. Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B).|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)||percentage point||Standard Deviation|Mean
768010|NCT00700817|Secondary|Mean Change From Baseline in Beta-cell Function at Week 52|"Calculated as an estimate of the mean change from baseline in beta-cell function at Week 52.
Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B)."|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||percentage point||Standard Error|Least Squares Mean
768011|NCT00700817|Secondary|Mean Change From Baseline in Beta-cell Function at Week 26|"Calculated as an estimate of the mean change from baseline in beta-cell function at Week 26.
Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B)."|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||percentage point||Standard Error|Least Squares Mean
768012|NCT00700817|Secondary|Mean Change in Fasting Plasma Glucose (FPG) From Week 52 to Week 78|Mean change in fasting plasma glucose (FPG) Week 52 to Week 78.|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)||mmol/L||Standard Deviation|Mean
768013|NCT00700817|Secondary|Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 78|Calculated as an estimate of the mean change in fasting plasma glucose (FPG) from baseline to Week 78.|Week 0, Week 78|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||mmol/L||Standard Error|Least Squares Mean
768014|NCT00700817|Secondary|Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52|Calculated as an estimate of the mean change from baseline in fasting plasma glucose (FPG) at Week 52.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||mmol/L||Standard Error|Least Squares Mean
768015|NCT00700817|Secondary|Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26|Calculated as an estimate of the mean change from baseline in fasting plasma glucose (FPG) at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||mmol/L||Standard Error|Least Squares Mean
768016|NCT00700817|Secondary|Mean Change in Body Weight From Week 52 to Week 78|Mean change in body weight from Week 52 to Week 78.|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)||kg||Standard Deviation|Mean
768017|NCT00700817|Secondary|Mean Change From Baseline in Body Weight at Week 52|Calculated as an estimate of the mean change from baseline in body weight at Week 52.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||kg||Standard Error|Least Squares Mean
768018|NCT00700817|Secondary|Mean Change From Baseline in Body Weight at Week 26|Calculated as an estimate of the mean change from baseline in body weight at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||kg||Standard Error|Least Squares Mean
768019|NCT00700817|Secondary|Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78|Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 78. Based on the extension 2 FAS.|Week 0, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)||percentage of subjects|||Number
768020|NCT00700817|Secondary|Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78|Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 78. Based on the FAS.|Week 0, Week 78|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||percentage of subjects|||Number
768021|NCT00700817|Secondary|Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 52|Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 52|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||percentage of subjects|||Number
768022|NCT00700817|Secondary|Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 26|Calculated as the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 26|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||percentage of subjects|||Number
768023|NCT00700817|Secondary|Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78|Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 78. Based on the extension 2 FAS.|Week 0, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)||percentage of subjects|||Number
768024|NCT00700817|Secondary|Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78|Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 78. Based on the FAS.|Week 0, Week 78|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||percentage of subjects|||Number
771915|NCT00731094|Secondary|Physical Function: 6MWD|Physical Function: 6MWD measured at Month 6|Month 6|||meters||Standard Deviation|Mean
768026|NCT00700817|Secondary|Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 26|Calculated as the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 26|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||percentage of subjects|||Number
768027|NCT00700817|Primary|Mean Change in Glycosylated Haemoglobin A1c (HbA1c) From Week 52 to Week 78|Mean Change in Glycosylated Haemoglobin A1c (HbA1c) from Week 52 to Week 78|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)||Percentage point of total HbA1c||Standard Deviation|Mean
768028|NCT00700817|Primary|Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 78|Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 78.|Week 0, Week 78|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||Percentage point of total HbA1c||Standard Error|Least Squares Mean
768029|NCT00700817|Primary|Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 52|Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 52.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||Percentage point of total HbA1c||Standard Error|Least Squares Mean
768030|NCT00700817|Primary|Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 26|Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||Percentage point of total HbA1c||Standard Error|Least Squares Mean
768031|NCT00700973|Primary|Addiction Severity Index Legal Composite|Scores range from 0 to 1, with higher scores indicating more severe legal problems.|One year post-intervention|||units on a scale||Standard Deviation|Mean
768032|NCT00700999|Primary|Percent Change in Brain Response Measured by Functional Magnetic Resonance Imaging (fMRI)|Mean percent change in brain response in the prefrontal cortex during an emotion reappraisal task in the treatment (paroxetine) group and in the Combat Exposed Control group. Target areas are analyzed from fMRI scans which were completed before participants receive treatment and again after participants received 12 weeks of treatment with paroxetine (20-40mg QD). Combat Exposed Control participants received an fMRI scan after signing initial consent and again 12 weeks later.|Baseline and 12 weeks|The number of participants analyzed is only 17 in each arm. The total number of participants in the Intervention group who completed fMRI scans pre-treatment and post treatment is only 19, in the Combat Exposed Control Group it is 18. Three of the participants scans were removed from data analysis due to the level of movement during the scan.||percent change in BOLD signal||Standard Deviation|Mean
768033|NCT00701038|Primary|Left Ventricular Ejection Fraction Improvement|Left ventricular function was assessed using doppler ultrasound. Positive increase in left ventricular function from baseline to 3 nights post treatment indicates potential beneficial impact of treatment on heart function.|baseline and again after three nights in hospital|ITT||percent change||Standard Error|Mean
768034|NCT00701051|Secondary|Body Composition (%Fat)||baseline, 24 weeks|Glucose tolerance data were analyzed as a continuous variable (combining Arms) as opposed to categorical (i.e., within each Arm) due to the sample size of this pilot study; thus, data are reported for the entire group of participants.||percentage of fat||Standard Error|Mean
768035|NCT00701051|Secondary|Cardiorespiratory Fitness|Maximal oxygen consumption|baseline, 24 weeks, 26 weeks|Glucose tolerance data were analyzed as a continuous variable (combining Arms) as opposed to categorical (i.e., within each Arm) due to the sample size of this pilot study; thus, data are reported for the entire group of participants.||L/Min||Standard Error|Mean
768036|NCT00701051|Primary|Skeletal Muscle Capillarization (Pre/Post Intervention)||baseline, 24 weeks, 26 weeks|Glucose tolerance data were analyzed as a continuous variable (combining Arms) as opposed to categorical (i.e., within each Arm) due to the sample size of this pilot study; thus, data are reported for the entire group of participants.||capillaries/mm2||Standard Error|Mean
768037|NCT00701051|Primary|Baseline Skeletal Muscle Capillarization||baseline|||capillaries/mm2||Standard Error|Mean
768038|NCT00701051|Secondary|Baseline Cardiorespiratory Fitness|maximal oxygen consumption|baseline|||L/min||Standard Error|Mean
768039|NCT00701051|Secondary|2-hr Post-prandial Plasma Glucose Level||baseline, 24 weeks, 26 weeks|Glucose tolerance data were analyzed as a continuous variable (combining Arms) as opposed to categorical (i.e., within each Arm) due to the sample size of this pilot study; thus, data are reported for the entire group of participants.||mg/dL||Standard Error|Mean
768040|NCT00701051|Primary|Glucose Utilization (Pre/Post Intervention)|Insulin-stimulated glucose uptake|baseline, 24 weeks, 26 weeks|Glucose tolerance data were analyzed as a continuous variable (combining Arms) as opposed to categorical (i.e., within each Arm) due to the sample size of this pilot study; thus, data are reported for the entire group of participants.||µmol/kgFFM/pmol insulin/min||Standard Error|Mean
768041|NCT00701051|Secondary|Baseline 2-hour Postprandial Glucose||baseline|||mg/dl||Standard Error|Mean
768042|NCT00701051|Primary|Baseline Glucose Utilization|Insulin-stimulated glucose uptake|baseline|||µmol/kgFFM/pmol insulin/min||Standard Error|Mean
768043|NCT00701064|Primary|Clinical Assessed PTSD Scale (CAPS-2) and Clinical Global Impression (CGI)|The CAPS-2 is administered by a trained clinician. It is designed to assess changes in PTSD severity over time, the scale ranges from 0-136. Higher levels indicate greater severity of PTSD.|Mean change from baseline to post-treatment (5-6 weeks later)|Separate analysis will be conducted to include drop-outs and exclusions. reported are end of study data||change in units on scale||Standard Deviation|Mean
768044|NCT00701090|Secondary|Percent of Patients With A1C <6.5% at Week 30||Week 30|The per protocol population included all patients with a baseline value, a measurement at Week 30, and no major protocol violations (i.e., drug compliance <85%, use of prohibited medications, change of Metformin dose, incorrect double-blind study medication).||Percentage of Participants|||Number
768045|NCT00701090|Secondary|Percent of Patients With A1C <7.0% at Week 30||Week 30|The per protocol population included all patients with a baseline value, a measurement at Week 30, and no major protocol violations (i.e., drug compliance <85%, use of prohibited medications, change of Metformin dose, incorrect double-blind study medication).||Percentage of Participants|||Number
768046|NCT00701090|Secondary|Change From Baseline in Body Weight at Week 30|Change from baseline at Week 30 was defined as Week 30 minus Week 0.|Week 0 to Week 30|All patients who took at least one dose of study therapy and had body weight measurements at both baseline and Week 30.||Kilograms||95% Confidence Interval|Least Squares Mean
768047|NCT00701090|Secondary|Percent of Patients With at Least One Hypoglycemia Episode of Any Type at Week 30||Week 0 to Week 30|All patients who took at least one dose of study therapy.||Percentage of Participants|||Number
768048|NCT00701090|Secondary|Change From Baseline in FPG (Fasting Plasma Glucose) at Week 30|Change from baseline at Week 30 was defined as Week 30 minus Week 0.|Week 0 to Week 30|The per protocol population included all patients with a baseline value, a measurement at Week 30, and no major protocol violations (i.e., drug compliance <85%, use of prohibited medications, change of Metformin dose, incorrect double-blind study medication).||mg/dL||95% Confidence Interval|Least Squares Mean
768049|NCT00701090|Primary|Change From Baseline in HbA1c at Week 30|Patient-level HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 30 HbA1c percent minus the Week 0 HbA1c percent.|Week 0 to Week 30|The per protocol population included all patients with a baseline value, a measurement at Week 30, and no major protocol violations (i.e., drug compliance <85%, use of prohibited medications, change of Metformin dose, incorrect double-blind study medication).||Percent||95% Confidence Interval|Least Squares Mean
768050|NCT00701103|Secondary|Percentage of Participants Who Experienced a Complete Response (CR) or Partial Response (PR)|Tumor responses were measured by using Response Evaluation Criteria in Solid Tumors (RECIST) criteria in participants with solid tumors and using European Group for Blood and Marrow Transplantation (EBMT) criteria in participants with multiple myeloma. RECIST criteria for CR: Disappearance of all target lesions. RECIST criteria for PR: ≥30% decrease in the sum of diameters of target lesions. EBMT criteria for CR: Disappearance of the original mAb protein from the blood and urine AND <5% plasma cells in the bone marrow AND no increase in the size or number of lytic bone lesions AND disappearance of soft tissue plasmacytomas AND normal serum calcium levels. EMBT criteria for PR: ≥50% reduction in the serum mAb protein level AND if a urine M-component is present, a reduction in 24-hour urinary light chain excretion by either ≥90% or to <200 mg AND ≥50% reduction in the size of soft tissue plasmacytomas AND no increase in size or number of lytic bone lesions.|Up to 2 years|The population consisted of all evaluable participants who received >90% of intended drug volume and had efficacy measurements at Baseline and at least once during treatment.||Percentage of Participants|||Number
768051|NCT00701103|Secondary|Percentage of Participants Who Developed a Serum Human-anti-humanized-antibody (HAHA) Response to Dalotuzumab|It is thought that the formation of HAHAs may block efficacy by prematurely clearing dalotuzumab and limit the possibility of future dalotuzumab therapy. Blood samples for the measurement of serum levels of HAHAs were obtained prior to treatment with dalotuzumab, and pre-dose Week 2 (Q1W), pre-dose Week 3 (Q2W), pre-dose Week 4 (QW3), pre-dose Week 5 (Q1W/Q2W), pre-dose Week 7 (Q2W/Q3W), pre-dose Week 9 (Q2W), pre-dose Week 10 (QW3) and pre-dose every 4 subsequent weeks and end of treatment (post-study: 4 weeks after last dose of study drug).|Up to 2 years|The population consisted of all participants who received >90% of intended drug volume and had measurements at Baseline and at least once during treatment.||Percentage of Participants|||Number
768052|NCT00701103|Secondary|Change From Baseline in IGF-1R Protein Expression Level H-score in Tumor Samples|IGF-1R expression was measured in pre- and post-dose tumor biopsy samples using an IHC assay as a function of time and dose. Results were expressed as an IGF-1R membrane H-score which could range from 0 to 300; with a score of 0 representing the absence of IGF-1R expression and an H-score of 300 representing maximum IGF-1R expression. Changes in IGF-1R expression levels from Baseline are summarized for all participants for whom these paired data were available. A post-dose decrease in IGF-1R membrane H-score was an indication of target engagement by dalotuzumab. A larger decrease in H-score correlated with a greater target engagement.|Predose in Cycle 1 (Baseline) and predose in Cycle 3 (Week 4)|The population consisted of all evaluable participants who received >90% of intended drug volume and had IGF-1R tumor pharmacodynamics measurements at Baseline and at least once during treatment. No data were available for the Dalotuzumab 2.5 mg/kg Q1W and Dalotuzumab 30 mg/kg Q3W treatment groups.||H-score||Standard Deviation|Mean
768053|NCT00701103|Secondary|Change From Baseline in Insulin-like Growth Factor Receptor Type 1 (IGF-1R) Protein Expression Level H-score in Skin Samples|IGF-1R expression was measured in pre- and post-dose skin biopsy samples using an immunohistochemistry (IHC) assay as a function of time and dose. Results were expressed as an IGF-1R membrane H-score which could range from 0 to 300; with a score of 0 representing the absence of IGF-1R expression and an H-score of 300 representing maximum IGF-1R expression. Changes in IGF-1R expression levels from Baseline are summarized for all participants for whom these paired data were available. A post-dose decrease in IGF-1R membrane H-score was an indication of target engagement by dalotuzumab. A larger decrease in H-score correlated with a greater target engagement.|Predose in Cycle 1 (Baseline) and predose in Cycle 3 (Week 4)|The population consisted of all evaluable participants who received >90% of intended drug volume and had skin IGF-1R pharmacodynamics measurements at Baseline and at least once during treatment. No data were available for the Dalotuzumab 30 mg/kg Q3W treatment group.||H-score||Standard Deviation|Mean
768054|NCT00701103|Primary|Mean Trough Serum Concentration (Ctrough) of Dalotuzumab|The lowest (trough) concentration of dalotuzumab prior to the next dose of dalotuzumab was measured.|Pre-dose immediately prior to second infusion: 168 hours for Q1W, 336 hours for Q2W and 504 hours for Q3W dosing|The population consisted of all evaluable participants who received >90% of intended drug volume and had mean trough serum concentration pharmacokinetic measurements at Baseline and at least once during treatment.||ug/mL||Standard Deviation|Mean
768055|NCT00701103|Primary|Mean Serum Clearance of Dalotuzumab|Clearance is defined as the volume of serum from which study drug was completely removed per unit of time. Blood samples for measurement of serum levels of dalotuzumab were obtained at: pre-dose; pre-end infusion; 0.5, 5, 10, 24, 30 (Q1W only), 48, 96, 168 (Q2W/Q3W only), 336 (Q3W only) hours post infusion. For infusions >1 hour in duration, an additional sample was obtained at the mid-point of the infusion.|Predose; pre-end infusion; 0.5, 5, 10, 24, 30 (Q1W only), 48, 96, 168 (Q2W/Q3W only), 336 (Q3W only) hours post-infusion|The population consisted of all evaluable participants who received >90% of intended drug volume and had mean serum clearance pharmacokinetic measurements at Baseline and at least once during treatment.||mL/min/kg||Standard Deviation|Mean
771916|NCT00731094|Secondary|Physical Function: 6-Minute Walking Distance (6MWD)|Physical Function: 6MWD in meters measured at Month 0|Month 0|||meters||Standard Deviation|Mean
768056|NCT00701103|Primary|Area Under the Time-concentration Curve From 0 to Infinity Hours (AUC0-∞) of Dalotuzumab|AUC0-∞ represents the total drug exposure over time. Blood samples for measurement of serum levels of dalotuzumab were obtained at: Predose; pre-end infusion; 0.5, 5, 10, 24, 30 (Q1W only), 48, 96, 168 (Q2W/Q3W only), 336 (Q3W only) hours post-infusion. For infusions >1 hour in duration, an additional sample was obtained at the mid-point of the infusion.|Predose; pre-end infusion; 0.5, 5, 10, 24, 30 (Q1W only), 48, 96, 168 (Q2W/Q3W only), 336 (Q3W only) hours post-infusion|The population consisted of all evaluable participants who received >90% of intended drug volume and had AUC0-last pharmacokinetic measurements at Baseline and at least once during treatment.||mg*hr/mL||Standard Deviation|Mean
768057|NCT00701103|Primary|Mean Terminal Half-life (t1/2) of Dalotuzumab|Terminal half-life is defined as the time it takes for the blood plasma concentration of a substance to halve (plasma half-life). Blood samples for measurement of serum levels of dalotuzumab were obtained at: pre-dose; pre-end infusion; 0.5, 5, 10, 24, 30 (Q1W only), 48, 96, 168 (Q2W/Q3W only), 336 (Q3W only) hours post infusion. For infusions >1 hour in duration, an additional sample was obtained at the mid-point of the infusion. Data presented are for the harmonic mean t1/2 for dalotuzumab.|Predose; pre-end infusion; 0.5, 5, 10, 24, 30 (Q1W only), 48, 96, 168 (Q2W/Q3W only), 336 (Q3W only) hours post-infusion|The population consisted of all evaluable participants who received >90% of intended drug volume and had t1/2 pharmacokinetic measurements at Baseline and at least once during treatment.||Hours||Full Range|Mean
768058|NCT00701103|Primary|Percentage of Participants Who Experienced One or More Dose-limiting Toxicities (DLTs)|Toxicity was graded and recorded according to National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events version 3.0 (CTCAE 3.0). A DLT was defined as any Grade 3 or 4 toxicity. A Grade 3 toxicity was defined as severe or medically significant but not immediately life-threatening OR hospitalization or prolongation of hospitalization indicated OR disabling OR limiting self care activities of daily living. A Grade 4 toxicity was defined as: life-threatening consequences OR urgent intervention indicated. Participants were monitored for the occurrence of DLTs during the first 3 weeks of dosing with dalotuzumab.|Up to 3 weeks|The population consisted of all participants who received at least one dose of study drug.||Percentage of Participants|||Number
768059|NCT00701129|Primary|Disability Index Assessed by the Pompe Pediatric Evaluation of Disability Inventory (Pompe PEDI) at End of Study|The Pompe PEDI is a disease specific version of the PEDI that was developed to assess functional capabilities and performance in children with Pompe disease from 2 months through adolescence. It consists of all items of the original PEDI (197 functional skill items in 3 domains: self-care; mobility; and social function) and additional items in the functional skills, mobility, and self-care domains to reflect clinically relevant functional skills for children with Pompe disease. Each domain consisted of 2 subdomains: functional skill performance and caregiver assistance scale. Norm-based scoring was developed for these additional items, and scoring algorithms for the PEDI have been adjusted to reflect additional normative data collected for the Pompe PEDI. Total score range for each domain (mean of subdomains) and subdomain ranges from 0 to 100, where higher score indicates high capability. End of study refers to the last post baseline observation during study period (up to Week 79).|End of study (up to Week 79 or early termination)|FAS population included all enrolled patients who signed informed consent and received at least 1 dose of alglucosidase alfa. Here, number of patient analyzed = number of patients with end of study Pompe PEDI assessment and n = number of patients with end of study assessment of specified category.||units on a scale||Full Range|Median
768060|NCT00701129|Primary|Motor Development Status Assessed by Alberta Infantile Motor Scale (AIMS) at End of Study|"AIMS is a 58-item reliable and valid measure of motor development for infants at risk for motor delay. It assesses infant movement in 4 positions (subscales): prone (reciprocal crawling); supine (moving hands to feet); sitting (sitting with arm support); and standing (pulls to stand). For each subscale, items were scored as observed or not observed. Item in the observed range create a motor window. When scoring, subscale scores are calculated by giving the child credit (1 point) for observed items within the motor window in addition to being given credit (1 point) for all of the less mature items before motor window. AIMS total score was calculated by summing the scores for 58 items and ranged from 0 to 58, with higher score indicating more mature motor development. Score was then compared with age-equivalent peers from normative sample and equivalence level age (in months) is reported. End of study refers to the last post baseline observation during study period (up to Week 79)."|End of study (up to Week 79 or early termination)|FAS population included all enrolled patients who signed informed consent and received at least 1 dose of alglucosidase alfa. Here, numbers of patients analyzed = patients with end of study AIMS assessment.||months||Full Range|Median
768061|NCT00701129|Primary|Gross Motor Disability Assessed by Gross Motor Function Measure-88 (GMFM-88) at End of Study|GMFM-88 is an 88-item measure to detect gross motor function. It consists of 5 categories: lying and rolling; sitting; crawling and kneeling; standing; walking, running and jumping. Each item is scored on a 4-point Likert scale (0 = cannot do; 1 = initiates [<10% of the task]; 2 = partially completes [10% to <100% of the task]; 3 = task completion). The score for each dimension is expressed as a percentage of the maximum score for that dimension. Total score is obtained by adding the percentage scores for each dimension and dividing the sum by the total number of dimensions. Total score ranges from 0% to 100%, where higher scores indicate better motor functions. A total score of <7.5% demonstrates gross motor disability. End of study refers to the last post baseline observation during study period (up to Week 79).|End of study (up to Week 79 or early termination)|FAS population included all enrolled patients who signed informed consent and received at least 1 dose of alglucosidase alfa. Here, numbers of patients analyzed = patients with end of study GMFM-88 assessment.||percentage of maximum total score||Full Range|Median
768062|NCT00701129|Primary|Number of Patients With Ventilator Use at End of Study|Number of patients who had ventilator support at end of study was reported. End of study refers to the last post baseline observation during study period (up to Week 79).|End of study (up to Week 79 or early termination)|FAS population included all enrolled patients who signed informed consent and received at least 1 dose of alglucosidase alfa.||participants|||Number
768099|NCT00701662|Secondary|Rate of AEs by Severity and Relatedness|"The rate was the number of AEs over the number of infusions administered. Included all AEs that occurred during the entire study period.
Mild AE: Did not interfere with routine activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities."|For the duration of the study, up to Week 25|The SDS comprised all treated patients.||AEs per infusion|Participants||Number
768063|NCT00701129|Primary|Number of Patients With Normal/Abnormal Left Ventricular Mass (LVM) Z-Score and LVM Index at End of Study|LVM Z-score and LVM index were assessed by ECHO. LVM Z-Score provides an indicator of degree of standard deviations from the mean in a normal distribution. Negative values indicate a smaller LVM than mean and values higher than 0 indicate a larger LVM than the mean. The normal range for LVM Z-Score is -2 to 2. Values <-2 or >2 indicate abnormal LVM Z-Score. LVM index is an index value derived by normalizing LVM by body surface area. LVM index provides evidence of cardiomyopathy. LVM index values <65 gram per meter^2 (g/m^2) were considered as normal and LVM index values >=65 g/m^2 were considered as abnormal. End of study refers to the last post baseline observation during study period (up to Week 79).|End of study (up to Week 79 or early termination)|FAS population included all enrolled patients who signed informed consent and received at least 1 dose of alglucosidase alfa.||participants|||Number
768064|NCT00701129|Primary|Number of Patients Who Survived at End of Study||Baseline up to End of study (Week 79)|FAS population included all enrolled patients who signed informed consent and received at least 1 dose of alglucosidase alfa.||participants|||Number
768065|NCT00701129|Primary|Number of Patients With Recombinant Human Acid Alfa-glucosidase (rhGAA) Inhibitory Antibody at End of Study|Patients with positive anti-rhGAA IgG antibody were assessed for the presence of inhibitory antibodies (inhibition of enzyme activity and inhibition of enzyme uptake). Enzyme-linked immunosorbent assay (ELISA) was used to measure inhibition of rhGAA enzymatic activity in vitro and a cell-based assay was used to measure the inhibition of the uptake of rhGAA in normal fibroblast cells by flow cytometry.|End of study (up to Week 79)|FAS population included all enrolled patients who signed informed consent and received at least 1 dose of alglucosidase alfa. Here, number of patients analyzed = patients with positive anti-rhGAA IgG antibody.||participants|||Number
768066|NCT00701129|Primary|Change From Baseline in Number of Patients With Anti-Recombinant Human Acid Alfa-glucosidase (Anti-rhGAA) Immunoglobulin G (IgG) Antibody at End of Study|Serum samples from patients were analyzed for the presence of anti-rhGAA IgG antibodies. End of study (EOS) refers to the last post baseline observation during study period (up to Week 79).|Baseline, End of Study (up to Week 79 or early termination)|FAS population included all enrolled patients who signed informed consent and received at least 1 dose of alglucosidase alfa.||participants|||Number
768067|NCT00701311|Primary|Global Response Assessment|"The primary efficacy measure was a Global Response Assessment (GRA), a subject completed questionnaire that measures improvement in overall symptoms on a 7-point scale: Markedly Improved - 7, Moderately Improved - 6, Mildly Improved - 5, Same - 4, Mildly Worse - 3, Moderately Worse - 2, Markedly Worse - 1.
The primary outcome showing response to treatment was the number of subjects that were moderately or markedly improved on the GRA scale."|12 weeks|||participants|||Number
768068|NCT00701363|Secondary|Subject Treatment Schedule Preference|"At week 24, the preference assessed between Octreotide Long Acting Repeatable intramuscular injection (Oct-LAR IM) every 4 weeks and Lanreotide Autogel 120 mg subcutaneous injection (SC) every 6 weeks.
At week 48, the preference is assessed between Oct-LAR IM every 4 weeks and Lanreotide Autogel 120 mg SC either injected every 4, 6 or 8 weeks (as injected during Phase II of the study)."|At weeks 24 and 48|"ITT population. n = Number of subjects at the visit.
Lan: Lanreotide
W: Week
Inj: Injection
Wks: Weeks
Phs: Phase
Grp: Group
evy: every"||Percentage of subjects|||Number
768069|NCT00701363|Secondary|Percentage of Subjects With GH Level Less Than or Equal to 2.5 ng/mL||At weeks 24 and 48|n = Number of subjects at the visit.||Percentage of subjects||95% Confidence Interval|Number
768070|NCT00701363|Secondary|Serum Growth Hormone (GH) Levels||At Baseline, week 24 and week 48|"ITT population. n = Number of subjects at the visit.
Phase 1 only: These 15 subjects participated only in phase 1 and did not move on to phase 2."||ng/mL||Standard Deviation|Mean
768071|NCT00701363|Secondary|Correlation Between the Changes From Baseline in Quality of Life (AcroQoL) With the Corresponding Changes in IGF-1 Level (Expressed as % of ULN) at Each Visit|"AcroQoL change from Baseline to Week 24 (48) = AcroQoL at Week 24 (48) - AcroQoL at Baseline.
IGF-1 change from Baseline to Week 24 (48) = IGF-1 at Week 24 (48) - IGF-1 at Baseline.
Correlation presented is a Spearman correlation (non parametric)."|At weeks 24 and 48|"ITT population. n = Number of subjects at the visit.
Only subjects from countries having a validated translation of the AcroQoL questionnaire (The Netherlands, Denmark, Sweden, France, Greece, Poland, South Korea, Brazil, Russia, Norway and Romania) were included."||Correlation coefficient||95% Confidence Interval|Number
768072|NCT00701363|Secondary|Percentage of Subjects With Normalized IGF-1 Levels (Age and Sex Adjusted), Without Any Worsening of the AcroQoL Change Score Between Inclusion and Week 48|The criterion for a subject is satisfied if he had a IGF-1 level (age and sex adjusted) without any worsening of the AcroQoL change score between Inclusion and Week 48.|At week 48 (End of Study)|"MITT population. n = Number of subjects at the visit.
Only subjects from countries having a validated translation of the AcroQoL questionnaire (The Netherlands, Denmark, Sweden, France, Greece, Poland, South Korea, Brazil, Russia, Norway and Romania) were included."||Percentage of subjects||95% Confidence Interval|Number
768073|NCT00701363|Secondary|Mean Changes From Baseline in Quality of Life Scores (SF-36)|Short Form-36 questionnaire (SF-36) score comprises eight components: Physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health on a scale of 100, where a score of 100 corresponds to the best possible QoL and 0 to the worst.|At weeks 24 and 48|ITT population. n = Number of subjects at the visit. Phase 1 only: These 15 subjects participated only in phase 1 and did not move on to phase 2.||Units on a scale||Standard Deviation|Mean
768074|NCT00701363|Secondary|Mean Changes From Baseline in Quality of Life Scores (AcroQoL)|AcroQoL score groups 22 components: Eight physical, Seven psychological appearance and Seven psychological personal relations, adjusted to a scale of 100, where a score of 100 corresponds to the best possible QoL and 0 to the worst.|At weeks 24 and 48|"ITT population n = Number of subjects at the visit. Phase 1 only: These subjects participated only in phase 1 & did not move onto phase 2.
Only subjects from countries having a validated translation of the AcroQoL questionnaire (The Netherlands, Denmark, Sweden, France, Greece, Poland, South Korea, Brazil, Russia, Norway and Romania) were included"||Units on a scale||Standard Deviation|Mean
768100|NCT00701662|Secondary|Number of Patients With Adverse Events (AEs) by Severity and Relatedness|"Included all AEs that occurred during the entire study period.
Mild AE: Did not interfere with routine activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities."|For the duration of the study, up to Week 25|The safety data set (SDS) comprised all treated patients.||participants|||Number
768075|NCT00701363|Secondary|Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia)|Acromegaly symptoms were assessed by the patients using the Patient Assessed Acromegaly Symptom Questionnaire (PASQ) scale ranging from 0 (No symptoms) to 8 (Severe, incapacitating symptoms).|At baseline, week 24 and week 48|"ITT population.
Number of Participants Analyzed:
Phase 1 in week 24: 3
Phase 2 (Group A) in week 24: 13
Phase 2 (Group B) in week 24: 69
Phase 2 (Group C) in week 24: 25
Phase 2 (Group A) in week 48: 13
Phase 2 (Group B) in week 48: 68
Phase 2 (Group C) in week 48: 26
NA = Not Applicable"||Units on a scale||Standard Deviation|Mean
768076|NCT00701363|Secondary|Mean Baseline IGF-1 Levels (Expressed as % of ULN) in All Groups (A, B and C) Versus Mean Baseline IGF-1 Levels (Expressed as % of ULN) in Subjects With Uncontrolled IGF-1 Levels at Week 24||Baseline (visit 1)|"ITT population. n = Number of subjects at the visit.
These subjects entered in phase 2
One subject was not included in this analysis because IGF-1 was lower than 130% at week 24 but not in the second phase and one subject in group A had missing IGF-1 value at baseline."||Percentage of ULN||95% Confidence Interval|Mean
768077|NCT00701363|Secondary|Treatment Group (A, B or C) Mean Baseline IGF-1 Levels (Expressed as % of ULN) in Subjects Who Maintained Normalised IGF-1 Values at Week 48. Comparisons Will be Made as Follows: A Versus B, A Versus C, A Versus (B+C) and B Versus C||Baseline (visit 1)|"MITT population.
One subject in Group A had missing IGF-1 value at baseline. One subject in Group B had missing IGF-1 value at week 48 and two subjects did not attend week 48 (early withdrawal). One subject in Group C had missing IGF-1 value at week 48."||Percentage of ULN||95% Confidence Interval|Mean
768078|NCT00701363|Secondary|Mean Change From Baseline in IGF-1 Values [Expressed as % of Upper Limit of Normal (ULN)], Overall and by Injection Interval|IGF-1 change from Baseline to Week 48 = Mean IGF-1 level at Week 48 - Mean IGF-1 level at Baseline|Baseline (visit 1) and week 48|MITT population. One subject (Group B) had missing IGF-1 value at Week 48. One subject (Group A) had missing IGF-1 value at Baseline.||Percentage of ULN||Standard Deviation|Mean
768079|NCT00701363|Secondary|Percentage of Subjects Who Extend Their Injection Interval to Eight Weeks During Phase 2 of the Study, Whilst Maintaining Normalised IGF-1 Levels|The criterion for a subject is satisfied if he extended his injection interval to eight weeks during Phase 2 of the study, whilst maintaining normalised IGF-1 levels at Week 48.|At week 48|ITT population. n = Number of subjects at the visit.||Percentage of subjects||95% Confidence Interval|Number
768080|NCT00701363|Secondary|Percentage of Subjects Having Maintained an Injection Interval of Six Weeks or Increasing Their Injection Interval to Eight Weeks|The criterion for a subject is satisfied if he maintained an injection interval of six weeks or increasing his injection interval to eight weeks during Phase 2 of the study.|During phase 2 of the study (up to week 48)|ITT population. n = Number of subjects at the visit.||Percentage of subjects||95% Confidence Interval|Number
768081|NCT00701363|Secondary|Percentage of Subjects With Normalised IGF-1 Levels (Age and Sex Adjusted)|The criterion for a subject is satisfied if he has a normalised IGF-1 level (age and sex adjusted) at week 24.|At week 24|ITT population. n = Number of subjects at the visit.||Percentage of subjects||95% Confidence Interval|Number
768082|NCT00701363|Primary|Percentage of Subjects Having Maintained Their Injection Interval Schedule of Six Weeks or Increased Their Injection Interval to Eight Weeks Whilst Keeping Their Normalised Insulin Growth Factor (IGF-1) Levels (Age and Sex Adjusted)|A subject was responder if he maintained his injection interval schedule of 6 weeks or increased his injection interval to eight weeks whilst keeping his normalised IGF-1 level (age and sex adjusted) at the end of the study (Week 48)|At week 48 (End of Study)|"Intention to Treat (ITT) population: All patients having received ≥1 study drug dose. Modified ITT (MITT) population: All subjects in the ITT population for whom group allocation was performed (included in Phase 2).
n = Number of subjects at the visit"||Percentage of subjects||95% Confidence Interval|Number
768083|NCT00701389|Secondary|Number of Participants Who Were Discontinued From Any Study Period Due to an Adverse Event|Participants were assessed throughout the study for adverse events. An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an adverse event. The number of participants who were discontinued from the study due to adverse event was summarized.|up to 10 weeks|All Patients as Treated defined as all participants who received at least one dose of the investigational drug. Adverse events were reported by study drug taken at the time of the event and not by randomly assigned sequence.||Participants|||Number
768084|NCT00701389|Secondary|Number of Participants Who Experienced an Adverse Event During the Study|Participants were assessed throughout the study for adverse events. An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an adverse event.|up to 14 days after last dose of study drug (up to 10 weeks)|All Patients as Treated defined as all participants who received at least one dose of the investigational drug. Adverse events were reported by study drug taken at the time of the event and not by randomly assigned sequence.||Participants|||Number
768085|NCT00701389|Secondary|Time-weighted Mean Arterial Pressure (Telcagepant Versus Placebo)|In each treatment period (1 through 4), duplicate readings of semi-recumbent blood pressure (BP) were completed using an automated blood pressure machine at predose, 30, 60, 90, 120, 150, 180, and 360 minutes postdose. Mean arterial pressure (MAP) was calculated as follows: MAP = Diastolic Blood Pressure (DBP) + (0.33 * Pulse Pressure [PP]) where PP = Systolic Blood Pressure [SBP] minus DBP. Only mean arterial pressure measurements up to and including 150 minutes postdose (including the predose measurement) were used to calculate the time-weighted averages. Time-weighted averages for each participant were obtained by calculating the area under the measurement-time curve of mean arterial pressure divided by the time period over which measurements were made (i.e. 150 minutes).|Predose up to 150 minutes postdose of each treatment period (up to 10 weeks)|Participants who were administered telcagepant or placebo in either Periods 1, 2, 3, or 4 regardless of sequence.||mmHg||95% Confidence Interval|Least Squares Mean
771936|NCT00731094|Secondary|Systolic BP|Systolic BP measured at Month 6|Month 6|||mmHg||Standard Deviation|Mean
768086|NCT00701389|Primary|Time-weighted Mean Arterial Pressure (Sumatriptan With Telcagepant Versus Sumatriptan Alone)|In each treatment period (1 through 4), duplicate readings of semi-recumbent blood pressure (BP) were completed using an automated blood pressure machine at predose, 30, 60, 90, 120, 150, 180, and 360 minutes postdose. Mean arterial pressure (MAP) was calculated as follows: MAP = Diastolic Blood Pressure (DBP) + (0.33 * Pulse Pressure [PP]) where PP = Systolic Blood Pressure [SBP] minus DBP. Only mean arterial pressure measurements up to and including 150 minutes postdose (including the predose measurement) were used to calculate the time-weighted averages. Time-weighted averages for each participant were obtained by calculating the area under the measurement-time curve of mean arterial pressure divided by the time period over which measurements were made (i.e. 150 minutes).|Predose up to 150 minutes postdose of each treatment period (up to 10 weeks)|Participants who were administered sumatriptan with telcagepant or sumatriptan alone in either Periods 1, 2, 3, or 4 regardless of sequence and had evaluable blood pressure data obtained.||mmHg||95% Confidence Interval|Least Squares Mean
768087|NCT00701415|Secondary|Percent Change From Baseline in GL-3 Clearance From Urine|Plasma samples were assayed for total urine GL-3 clearance using a validated tandem mass spectrometry with an upper limit of normal of <0.030 mg/mmoL of creatinine. Number of participants analyzed=participants with both baseline and post-baseline GL-3 urine clearance assessment. Here 'n' signifies number of participants with available data for specified category.|Baseline, Week 12, 28, 40, 52, 80, 104, 132, 156, 184, 208, 236 and 260|Analysis was performed on FAS.||Percent change||Standard Deviation|Mean
768088|NCT00701415|Secondary|Percent Change From Baseline in GL-3 Clearance From Plasma|Plasma samples were assayed for GL-3 clearance using a validated tandem mass spectrometry with an upper limit of normal plasma GL-3 level of 7.0 μg/mL. Number of participants analyzed=participants with both baseline and post-baseline GL-3 plasma clearance assessment. Here 'n' signifies number of participants with available data for specified category.|Baseline, Week 12, 28, 40, 52, 80, 104, 132, 156, 184, 208, 236 and 260|Analysis was performed on FAS.||Percent change||Standard Deviation|Mean
768089|NCT00701415|Primary|Skin Globotriaosylceramide (GL-3) Clearance From Superficial Skin Capillary Endothelium|Skin biopsies were taken at Baseline, Week 52, Week 156 and Week 260 or early withdrawal and analyzed for cellular GL-3 accumulation (inclusions) by light microscopy. Each biopsy was scored for GL-3 accumulation on a severity score-scale of none, mild, moderate, severe (0-1-2-3). Scores are categorized as normal (score = 0) or abnormal (score = 1, 2 or 3). Data was summarized in terms of number of participants with none/trace, mild, moderate and severe biopsy scores.|Baseline, Week 52, Week 156 and Week 260|Analysis was performed on Full analysis set (FAS), which included all randomized participants who received at least 1 infusion of study treatment.||Percentage of participants|||Number
768090|NCT00701441|Other Pre-specified|Peroxynitrite Deposition in the Vascular Walls|A forearm biopsy will be collected to isolate human microcirculatory endothelial cells. The stain density of peroxynitrite, an indicator of oxidative stress, in the vascular walls is compared between pre-treatment and post treatment patient tissue. Also another comparison is made between pre-treatment and control tissue. The stain density is a software-generated measurement of pixel intensity and is considered to be an arbitrary unit. Higher numbers indicate greater density|baseline and 12 weeks|Comparative values analyzed for those with endothelial nitric oxide synthase and flow mediated dilation only.||stain density units||Standard Error|Mean
768091|NCT00701441|Primary|Flow Mediated Dilation|A non-invasive test using an ultrasound to measure baseline resting vessel diameter and vessel wall dilation in upper arm post application of an inflated blood pressure cuff for five minutes. The percentage change in vessel wall dilation due to stimulation from the resting vessel diameter will be calculated for each group of participants. The results will be compared relative to each group of participants.|Baseline and 12 weeks|Comparative values analyzed for those with endothelial nitric oxide synthase and nitrotyrosine stain density values only.||percentage change of vessel diamter||Standard Error|Mean
768092|NCT00701558|Secondary|Overall Survival|Overall survival was defined as the interval between the day of randomization and the date of death from any cause.|From the time of randomization until death (up to 193 weeks)|ITT population included all participants who were randomized to treatment group.||weeks||95% Confidence Interval|Median
768093|NCT00701558|Primary|Overall Response Rate (ORR)|Overall response rate was defined as the percentage of participants who had any evidence of confirmed objective complete response (CR) or partial response (PR), per the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) and assessed by computed tomography imaging (CT): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|From the time of randomization until disease progression or death (up to 193 weeks)|ITT population included all participants who were randomized to treatment group.||percentage of participants|||Number
768094|NCT00701558|Primary|Time to Disease Progression|Time to disease progression or progression free survival (PFS) was defined as the interval between the day of randomization and the date of the first documentation of disease progression or date of death (from any cause), whichever occurs first.|From the time of randomization until disease progression or death (up to 193 weeks)]|Intention to treat (ITT) population included all participants who were randomized to treatment group.||weeks||95% Confidence Interval|Median
768095|NCT00701636|Primary|Mean Daptomycin Concentrations at 12, 18, 24, and 48 h|Mean daptomycin concentrations (mcg/ml) at 12, 18, 24, and 48 h|Hospital discharge or 7 days, whichever comes first|Based on sample sizes from previously published studies on antibiotic pk for CABG surgery.||mcg/ml||Standard Deviation|Mean
768096|NCT00701662|Secondary|Number of Patients With Clinically Relevant Changes in Vital Signs|Vital signs included heart rate, systolic blood pressure, diastolic blood pressure, and body temperature.|Baseline to Week 25|The SDS comprised all treated patients.||participants|||Number
768097|NCT00701662|Secondary|Number of Patients With Clinically Relevant Changes in Laboratory Parameters|Laboratory parameters included hematology, serum chemistry, and urinalysis parameters.|Baseline to Week 25|The SDS comprised all treated patients.||participants|||Number
768098|NCT00701662|Secondary|Number of Patients With Local/Injection Site Reactions|All AEs arising from local/injection site reactions.|For the duration of the study, up to Week 25|The SDS comprised all treated patients.||participants|||Number
768176|NCT00694473|Primary|Sensitivity and Specificity of Navigator Threshold Alarms for Hypoglycemia (<60 mg/dl).||72 hours|This measure was not calculated as we did not have sufficient data to calculate sensitivity (not enough hypoglycemia) and discordant BG check times to calculate specificity.|||||
768101|NCT00701662|Secondary|Overall Health Status at Baseline and Week 25|Overall Health Status was assessed using a Visual Analogue Scale (VAS). Patients were asked to rate their overall health status by placing a mark on a 100 mm VAS, with 0 being the worst imaginable state and 100 being the best imaginable state.|Baseline and week 25|The analysis population comprised the subjects in the ITT data set (ie, all patients treated with the study drug) who had at least one post-baseline value (and if necessary a baseline value).||units on a scale||Full Range|Mean
768102|NCT00701662|Secondary|Treatment Satisfaction at Baseline and Week 25|Treatment satisfaction was assessed using the Life Quality Index, which comprises 15 items rated on a 7-point scale (1 = worst rating, 7 = best rating) with a possible maximum score of 105. The highest score indicates the highest satisfaction with the impact of treatment on social factors. The 15 items were summarized to 4 scales: treatment interference, therapy-related problems, therapy setting, and treatment costs. The raw scores for these scales were transformed to a score ranging from 0 to 100, with 100 being the best score achievable.|At baseline and week 25|The analysis population comprised the subjects in the ITT data set (ie, all patients treated with the study drug) who had at least one post-baseline value (and if necessary a baseline value).||units on a scale||Full Range|Mean
768103|NCT00701662|Secondary|Health-Related Quality of Life at Baseline and Week 25|"Assessed using a questionnaire on patients' satisfaction with current immunoglobulin G (IgG) treatment, treatment at home, and treatment at the hospital/doctor's office. The questions were answered by choosing a number between 1 (extremely good) and 7 (extremely bad).
Note: No patients received IgG treatment at the hospital/doctor's office at Week 25."|At baseline and week 25|The analysis population comprised the subjects in the ITT data set (ie, all patients treated with the study drug) who had at least one post-baseline value (and if necessary a baseline value).||units on a scale||Full Range|Mean
768104|NCT00701662|Secondary|Mean Motor Function Score at Screening and Week 25|For each patient, four specific tasks were defined according to his/her weakened muscle group. The patient had to grade each of the tasks on a 5-point scale ranging from 0 (normal function) to 4 (not possible). The overall motor function score was calculated as the sum of the 4 grades, resulting in a score ranging from 0 (optimal) to 16 (worst).|Screening and week 25|The analysis population comprised the subjects in the ITT data set (ie, all patients treated with the study drug) who had at least one post-baseline value (and if necessary a baseline value).||score on a scale||Full Range|Mean
768105|NCT00701662|Primary|Mean Overall MRC Score at Baseline and Week 24|The 200-point MRC sum score is the sum of scores for 20 bilateral (left and right side) muscle groups, each rated between 0 (no movement) to 5 (normal movement/power). A higher MRC sum score indicates greater muscle contraction/limb movement.|Baseline and week 24|The ITT data set comprised all patients treated with the study drug who had at least one post-baseline measurement for muscle strength.||score on a scale||Full Range|Mean
768106|NCT00701662|Secondary|Change From Baseline to the Completion Visit in Motor Function|"The change in motor function was determined at the completion visit compared to baseline using descriptive statistics and nonparametric two-sided 95% confidence intervals based on the Hodges-Lehmann method.
For each patient, four specific tasks were defined according to his/her weakened muscle group. The patient had to grade each of the tasks on a 5-point scale ranging from 0 (normal function) to 4 (not possible). The overall motor function score was calculated as the sum of the 4 grades, resulting in a score ranging from 0 (optimal) to 16 (worst). The baseline motor function score was calculated as the mean of the patient's assessments at Screening and Week 1. Negative values for change in motor function score indicate improvement, with a more negative value indicating greater improvement compared with the value at baseline."|Baseline to the completion visit (up to week 25)|The analysis population comprised the subjects in the ITT data set (ie, all patients treated with the study drug) who had at least one post-baseline value (and if necessary a baseline value).||score on a scale||95% Confidence Interval|Mean
768107|NCT00701662|Secondary|Mean Disability Score at Baseline and Week 24|Disability was measured using a modified Guy’s Neurological Disability Scale, which comprises subscales for upper and lower limb disability. Both subscales comprise 6 grades, numbered from 0 (no upper limb problem/walking is not affected) to 5 (unable to use either arm for any purposeful movements/usually uses a wheelchair indoors). The disability score is calculated as the sum of both subscales, resulting in a score ranging from 0 to 10. A higher disability score indicates greater disability.|Baseline and Week 24|The analysis population comprised the subjects in the ITT data set (ie, all patients treated with the study drug) who had at least one post-baseline value (and if necessary a baseline value).||score on a scale||Full Range|Mean
768108|NCT00701662|Secondary|Change From Baseline to Week 24 in Disability|"The change in disability score was determined at week 24 compared to baseline using descriptive statistics and nonparametric two-sided 95% confidence intervals based on the Hodges-Lehmann method. Data for one of the eight subjects was from week 13 as week 24 data were not available.
Disability was measured using a modified Guy’s Neurological Disability Scale, which comprises subscales for upper and lower limb disability. Both subscales comprise 6 grades, numbered from 0 (no upper limb problem/walking is not affected) to 5 (unable to use either arm for any purposeful movements/usually uses a wheelchair indoors). The disability score is calculated as the sum of both subscales, resulting in a score ranging from 0 to 10. A higher disability score indicates greater disability. Negative values for change in disability score indicate improvement, with a more negative value indicating greater improvement compared with the value at baseline."|Baseline to week 24|The analysis population comprised the subjects in the ITT data set (ie, all patients treated with the study drug) who had at least one post-baseline value (and if necessary a baseline value).||score on a scale||95% Confidence Interval|Mean
768109|NCT00701662|Primary|Change From Baseline to Week 24 in Muscle Strength|"The change in Medical Research Council (MRC) score was determined at week 24 compared to baseline using descriptive statistics and nonparametric, two-sided 95% confidence intervals based on the Hodges-Lehmann method. Data for one of the eight subjects was from week 13 as week 24 data were not available.
The 200-point MRC sum score is the sum of scores for 20 bilateral (left and right side) muscle groups, each rated between 0 (no movement) to 5 (normal movement/power). A higher MRC sum score indicates greater muscle contraction/limb movement. Positive values for change in MRC sum score indicate improvement, with a more positive value indicating greater muscle contraction/ limb movement compared with the value at baseline."|Baseline to week 24|The Intention-to-Treat (ITT) data set comprised all patients treated with the study drug who had at least one post-baseline measurement for muscle strength.||score on a scale||95% Confidence Interval|Mean
768110|NCT00701675|Primary|Comparisons of End of Study HAM-A Score Means for Sertraline 50 mg vs Placebo, Sertraline 100 mg vs Placebo, and Sertraline 50 mg vs. Sertraline 100 mg|Least squares (LS) means estimate and p-value from mixed effects model with baseline and site as covariates and Tukey-Kramer adjustment for multiple comparisons Hamilton Rating Scale for Anxiety (HAM-A) is a widely used rating scale for anxiety describes the presence/absence of the severity of anxiety symptoms. It's clinician-rated scale of 14 items rated from 0-4. Generally, total score of <17 is mild anxiety; 18-24 is mild to moderate, and 25 and up is moderate to severe.|11 weeks from baseline|sertraline 50mg group and placebo group each had 2 subjects with missing data.||units on a scale||95% Confidence Interval|Least Squares Mean
768111|NCT00701727|Secondary|High-density Lipoprotein (HDL)|Change from baseline in plasma HDL, measured in fasting blood samples|7 weeks|per protocol, all subjects||mg/dL HDL||Standard Deviation|Mean
768112|NCT00701727|Secondary|Low-density Lipoprotein (LDL);|Change from baseline in plasma low-density lipoprotein(LDL), measured in fasting blood samples|7 weeks|per protocol, all subjects||mg/dL LDL||Standard Deviation|Mean
768113|NCT00701727|Secondary|Triglycerides (TG)|Change from baseline in plasma triglycerides, measured in fasting blood samples|7 weeks|per protocol, all subjects||mg/dL TG||Standard Deviation|Mean
768114|NCT00701727|Secondary|Cholesterol Efflux Rate (Ra Cholesterol)|The efflux, or mobilization, rate of cholesterol from peripheral tissues into the plasma will be measured as mg/kg/hr. An IV infusion of [13C2] cholesterol mixed in 10% Intralipid® and 10 % ethanol is given piggy-backed into normal saline over 20 hours (4pm – 12 noon). This is used to determine rate of appearance (Ra) cholesterol, which will be measured by dilution of infused [13C2] cholesterol during the plateau phase of plasma enrichment (approximately the last 4 hours of the infusion), as well as to provide the plasma cholesterol that will be traced into biliary sterols.|7 weeks|per protocol, all subjects||mg/kg/hr cholesterol||Standard Deviation|Mean
768115|NCT00701727|Secondary|de Novo Cholesterol Synthesis (DNC)|Plasma DNC will be measured following the isotope infusion of deuterated water, expressed as %.|7 weeks|per protocol, all subjects||%/day plasma DNC||Standard Deviation|Mean
768116|NCT00701727|Secondary|Change From Baseline in Total Cholesterol, From Fasting Plasma Samples|plasma levels of total cholesterol|7 weeks|per protocol, all subjects||mg/dL total cholesterol||Standard Deviation|Mean
768117|NCT00701727|Primary|Fecal Excretion of Plasma-derived Cholesterol|"(Fecal excretion of plasma-derived cholesterol):The following measurements will be made following isotope infusion:
The composition of fecal neutral and acidic sterols will be measured as % of total.
The excretion rate of fecal neutral and acidic sterols will be measured as mg/day.
The isotopic enrichment of both fecal neutral and acidic sterols will be measured as atomic percent excess (% APE).
Fecal isotope excretion, or recovery, of plasma-derived cholesterol will be calculated as %/day."|7 weeks|Per Protocol,all subjects||mg/day cholesterol excreted||Standard Deviation|Mean
768118|NCT00701779|Primary|Prostate Specific Antigen|Prostate Specific Antigen (PSA) taken at final study visit (12 month) to assess efficacy of starting with combination treatment with Dutasteride for one year and Tamsulosin for 3 months with subsequent as needed use of Tamsulosin in providing superior symptomatic improvement to BPH patients.|12 months|||ng/mL||Standard Deviation|Mean
768119|NCT00701779|Primary|Post-void Residual Volume|Post-void residual volume taken at final study visit (12 month) to assess efficacy of starting with combination treatment with Dutasteride for one year and Tamsulosin for 3 months with subsequent as needed use of Tamsulosin in providing superior symptomatic improvement to BPH patients.|12 months|||mL||Standard Deviation|Mean
768120|NCT00701779|Primary|Benign Prostate Hyperplasia Impact Index|"Benign prostate hyperplasia Impact Index obtained at final study visit (12 month) to assess efficacy of starting with combination treatment with Dutasteride for one year and Tamsulosin for 3 months with subsequent as needed use of Tamsulosin in providing superior symptomatic improvement to BPH patients.
Benign Prostatic Hyperplasia Impact Index asked the following:
Over the past month, how much physical discomfort did any urinary problems cause you? (0-3)
Over the past month, how much did you worry about yoru health because of any urinary problems? (0-3)
Overall, how bothersome has any trouble with urination been during the past month? (0-3)
Over the past month, how much of the time has any urinary problem kept you from doing the kinds of things you usually do? (0-4) 0 indicates no symptoms, high values indicate high frequency of symptoms. Total symptom score range 0-13."|12 months|||units on a scale||Standard Deviation|Mean
768121|NCT00701779|Primary|Peak Flow Rate (QMax)|Peak flow rate recorded at final study visit (12 month) to assess efficacy of starting with combination treatment with Dutasteride for one year and Tamsulosin for 3 months with subsequent as needed use of Tamsulosin in providing superior symptomatic improvement to BPH patients.|12 months|||ml/sec||Standard Deviation|Mean
768122|NCT00701779|Primary|International Prostate Symptom Score|"Reported mean total IPSS values from end of study (12 month visit) to assess efficacy of starting with combination treatment with Dutasteride for one year and Tamsulosin for 3 months with subsequent as needed use of Tamsulosin in providing superior symptomatic improvement to BPH patients.
Questionnaire consisting of seven symptom scores: incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Symptoms are scored on a 5 point scale with 0 representing absence of symptoms and 5 representing the most severe presentation of a symptom.
Total range is from 0-35. The scores are evaluated as such:
0-7: Mild 8-19: Moderate 20-35: Severe"|12 months|||units on a scale||Standard Deviation|Mean
768123|NCT00701779|Secondary|Reduction of AUR and BPH-related Surgery|To assess efficacy of starting with combination treatment with Dutasteride for one year and Tamsulosin for 3 months with subsequent as needed use of Tamsulosin in providing superior improvement in the clinical outcomes of AUR or BPH-related prostatic surgery to BPH patients.|13 months||||||
768124|NCT00701779|Secondary|Economic Impact|To assess the pharmacoeconomic impact on starting with combination therapy with Dutasteride and Tamsulosin with subsequent withdrawal of Tamsulosin.|13 months||||||
768125|NCT00701779|Secondary|Safety and Tolerability|To assess safety and tolerability of starting with combination therapy with Dutasteride and Tamsulosin and subsequent elimination of Tamsulosin. Evaluating number of reported adverse events designated as possibly or probably study-drug related.|13 months|||adverse events|||Number
768126|NCT00701779|Secondary|Health Outcome Measures|To assess the effects of starting with combination therapy with Dutasteride and Tamsulosin and subsequent withdrawal of Tamsulosin on health outcome measures.|13 months||||||
771937|NCT00731094|Secondary|Systolic Blood Pressure (BP)|Systolic BP in millimeters of mercury (mmHg) measured at Month 0|Month 0|||mmHg||Standard Deviation|Mean
768127|NCT00701805|Secondary|The Percentage of Participants Whose Abnormal Baseline Bone Specific Alkaline Phosphatase (BSAP) Was Normalized at Final Visit||From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53)|All subjects who received at least 1 dose of paricalcitol in this study and who had abnormal BSAP at Baseline.||Percentage of participants|||Number
768128|NCT00701805|Secondary|The Percentage of Participants Whose Abnormal Baseline Alkaline Phosphatase Was Normalized at Final Visit||From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53)|All subjects who received at least 1 dose of paricalcitol in this study and who had abnormal alkaline phosphatase at Baseline.||Percentage of participants|||Number
768129|NCT00701805|Other Pre-specified|The Percentage of Participants With Hypercalcemia|The percentage of participants with an event of hypercalcemia, defined as at least 1 adjusted calcium > 11.5 mg/dL or at least 2 consecutive adjusted calcium >= 11.0 mg/dL during Study M10-312 (Weeks 13 through 53)|Anytime from Week 13 through Week 53|||Percentage of participants|||Number
768130|NCT00701805|Secondary|Duration of 2 Consecutive iPTH Values <= 180 pg/mL||From Baseline to the participant's Final Visit (which could occur anytime between study initiation to Week 53)|All subjects who received at least 1 dose of paricalcitol in this study and who were included in the Full Analysis Set.||days||Standard Deviation|Mean
768131|NCT00701805|Secondary|Duration of 2 Consecutive Decreases in iPTH >= 50%||From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53)|All subjects who received at least 1 dose of paricalcitol in this study and who were included in the Full Analysis Set.||days||Standard Deviation|Mean
768132|NCT00701805|Secondary|Change in Mean iPTH||Every week from Baseline through Week 13 and every other week thereafter until Week 53|All subjects who received at least 1 dose of paricalcitol in this study and who were included in the Full Analysis Set.||pg/mL||Standard Deviation|Mean
768133|NCT00701805|Secondary|The Percentage of Participants With 2 or More Decreases From Baseline in iPTH of >= 50%||Anytime during the study from Baseline to the participant's final visit (which could occur anytime from study initiation to Week 53)|All subjects who received at least 1 dose of paricalcitol in this study and who were included in the Full Analysis Set.||Percentage of Participants|||Number
768134|NCT00701805|Secondary|The Percentage of Participants With iPTH <= 180 pg/mL or >= 50% Decrease of iPTH at the Participant's Final Visit||From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53)|All subjects who received at least 1 dose of paricalcitol in this study and who were included in the Full Analysis Set.||Percentage of participants|||Number
768135|NCT00701805|Secondary|The Mean Change in Intact Parathyroid Hormone (iPTH)||From Baseline to Final Visit (which could occur anytime between study initiation and Week 53)|All subjects who received at least 1 dose of paricalcitol in this study and who were included in the Full Analysis Set.||picograms/milliliter (pg/mL)||95% Confidence Interval|Mean
768136|NCT00701805|Primary|The Percentage of Participants With Hyperphosphatemia|The percentage of participants with an event of hyperphosphatemia, defined as at least 2 consecutive phosphorus >= 7.0 mg/dL during the 52 weeks of the study.|Anytime during the study through Week 53|All subjects who received at least 1 dose of paricalcitol in this study.||Percentage of participants|||Number
768137|NCT00701805|Primary|The Percentage of Participants With of Hypercalcemia|The percentage of participants with an event of hypercalcemia, defined as at least 1 adjusted calcium > 11.5 mg/dL or at least 2 consecutive adjusted calcium >= 11.0 mg/dL during the 52 weeks of the study.|Anytime during the study through Week 53|All subjects who received at least 1 dose of paricalcitol in this study.||Percentage of participants|||Number
768138|NCT00701935|Secondary|Assessment of Event Rate of Treatment- Emergent Hypoglycemic Event|All hypoglycemia episodes defined as major (results in loss of consciousness, seizure or coma resolving after administration of glucagon or glucose OR needing third-party assistance to resolve due to severe impairment in consciousness and associated with glucose concentration < 2.8 mol/L.) or minor (non-major event with symptoms consistent with hypoglycemia and glucose value < 2.8 mmol/L prior to treating) or symptoms of hypoglycemia (does not meet the criteria for a major or minor event).|baseline, 6 months|Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug.||hypoglycemia rate/year||Standard Error|Mean
768139|NCT00701935|Secondary|Change in High-Density Lipoprotein (HDL) Cholesterol From Baseline to 6 Months|Change in HDL cholesterol|baseline, 6 months|Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received||mmol/L||Standard Error|Least Squares Mean
768140|NCT00701935|Secondary|Change in Triglycerides From Baseline to 6 Months|Change in triglycerides|baseline, 6 months|Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received||mmol/L||Standard Error|Least Squares Mean
768141|NCT00701935|Secondary|Change in Total Cholesterol From Baseline to 6 Months|Change in total cholesterol|baseline, 6 months|Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received||mmol/L||Standard Error|Least Squares Mean
768142|NCT00701935|Secondary|Change in Diastolic Blood Pressure From Baseline to 6 Months|Change in Diastolic blood pressure|baseline, 6 months|Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug.||mmHg||Standard Deviation|Mean
768143|NCT00701935|Secondary|Change in Systolic Blood Pressure From Baseline to 6 Months|Change in Systolic blood pressure|baseline, 6 months|Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug.||mmHg||Standard Deviation|Mean
768144|NCT00701935|Secondary|Change in Weight From Baseline to 6 Months|Change in weight|baseline, 6 months|Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received. Last observation (month 6 or early discontinuation) was analyzed.||kg||Standard Error|Least Squares Mean
768173|NCT00694473|Secondary|Sensitivity and Specificity of Navigator Projected Low Blood Sugar Alarm Criteria Calculated for Events Defined by a Low Reference BG Value (< 60 mg/dL)||72 hours|This measure was not calculated as we did not have sufficient data to calculate sensitivity (not enough hypoglycemia) and discordant BG check times to calculate specificity.|||||
768145|NCT00701935|Secondary|Change in Fasting Plasma Glucose From Baseline to 6 Months|Change in Fasting plasma glucose|baseline, 6 months|Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received. Analysis done only for patients with measurement at Month 6.||mmol/L||Standard Error|Least Squares Mean
768146|NCT00701935|Secondary|Percentage of Patients With HbA1c <=7.0% at 6 Months|Percentage of patients with HbA1c values <= 7.0% measured at 6 months. HbA1c is a measurement of the amount of hemogobin that is glycosylated.|6 months|Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received.Analysis done only for patients with measurement at Month 6.||Percentage of patients|||Number
768147|NCT00701935|Secondary|Change in HbA1c From Baseline to 6 Months|Change in HbA1c from baseline to 6 months. HbA1c is a measurement of the amount of hemogobin that is glycosylated.|baseline, 6 months|Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received. Last observation (month 6 or early discontinuation) was analysed.||% change||Standard Error|Least Squares Mean
768148|NCT00701935|Secondary|Percentage Change in Subcutaneous Abdominal Fat From Baseline to 6 Months|Percentage change in subcutaneous abdominal fat|baseline, 6 months|Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received||% change||Standard Error|Least Squares Mean
768149|NCT00701935|Secondary|Percentage Change in Total Abdominal Fat From Baseline to 6 Months|Percentage change in total abdominal fat|baseline, 6 months|Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received||% change||Standard Error|Least Squares Mean
768150|NCT00701935|Primary|Percentage Change in Abdominal Visceral Fat From Baseline to 6 Months|Percentage change in abdominal visceral fat|baseline, 6 months|Primary analysis done on the Intent To Treat (ITT) Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received||% change||Standard Error|Least Squares Mean
768151|NCT00702143|Primary|Mean Cortical to Cerebellum SUVR|Standardized Uptake Value ratio (SUVR) is the ratio of tracer uptake in predefined cortical regions, relative to uptake in the whole cerebellum.|50-60 min after injection|One healthy subject received florbetapir F 18 but due to technical difficulties with the scanner was not imaged and is therefore not included in the efficacy population.||SUVR||Standard Deviation|Mean
768152|NCT00702143|Secondary|Proportion of Positive Florbetapir-PET Scans|Three readers blinded to all clinical information classified florbetapir-PET images as either positive for amyloid or negative for amyloid. The majority read was used to determine the proportion of positive scans across the three groups.|50-60 min after injection|One healthy subject received florbetapir F 18 but due to technical difficulties with the scanner was not imaged and is therefore not included in the efficacy population.||percentage of amyoid positive scans|||Number
768153|NCT00702143|Primary|Qualitative Amyloid Image Assessment|Three readers blinded to all clinical information classified florbetapir-Positron Emission Tomography (PET) images as either positive for amyloid or negative for amyloid. The majority read was the primary efficacy endpoint for the qualitative evaluation.|50-60 min after injection|One healthy subject received florbetapir F 18 but due to technical difficulties with the scanner was not imaged and is therefore not included in the efficacy population.||participants|||Number
768154|NCT00702208|Primary|Kappa Coefficient|Kappa comparing clinician-collected cytology result to self-lavage cytology result|1-3 months between 2 specimen collections|||kappa coefficient for paired specimens||95% Confidence Interval|Number
768155|NCT00702208|Secondary|Outcome: Acceptability of Device|On a visual analog scale from 0-10 cm, preference for clinician-collected specimen (0) vs. self-lavage specimen (10) for future cervical cancer screening|cross-sectional - asked at time of Screener use|For acceptability, 197 women used the device; 30 of these women did not have valid gold standard results but did respond to acceptability, thus for acceptability endpoint the sample size is 197 (while the sample size is 167 for sensitivity, specificity and kappa analyses due to insufficient sepcimens /loss to follow-up for colposcopy).||units on a scale||Inter-Quartile Range|Median
768156|NCT00702208|Primary|Sensitivity and Specificity|"We calculated sensitivity of self-collected lavage with cytology to detect histologically confirmed high grade lesions (cervical intraepithelial neoplasia, CIN, 2+); specificity for histology-negative (CIN 1 or lower), paired cytology negative, or a third cytology negative; and kappa for paired results.
The cytology specimens were collected 1-3 months apart and women with abnormal results for cytology were followed through January 2010 for final histology endpoints."|1-3 months between 2 specimen collections|||% of participants correctly diagnosed||95% Confidence Interval|Number
768157|NCT00702221|Primary|Change From Baseline to Week 8 in Mean Daytime Diastolic Blood Pressure (DBP) Measured by Ambulatory Blood Pressure Monitoring (ABPM)||baseline to 8 weeks|study prematurely terminated||mmHg||Standard Error|Mean
768158|NCT00702234|Primary|Number of Live Born Infants Experiencing SAEs|An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.|Up to 12 weeks after birth|Follow-up safety analysis was performed on live born infants delivered by expectant mothers who received corifollitropin alfa in base study P05714 (NCT00696878) and who enrolled in the follow-up study.||participants|||Number
768159|NCT00702234|Primary|Number of Live Born Infants Experiencing AEs|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|Up to 12 weeks after birth|Follow-up safety analysis was performed on live born infants delivered by expectant mothers who received corifollitropin alfa in base study P05714 (NCT00696878) and who enrolled in the follow-up study.||participants|||Number
768160|NCT00702234|Primary|Number of Expectant Mothers Experiencing Serious AEs (SAEs)|An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.|From approximately 10 weeks after fresh ET in base study P05714 up to birth of infant (up to approximately 6 months)|Follow-up safety analysis was performed on expectant mothers who received corifollitropin alfa in base study P05714 (NCT00696878) and who enrolled in the follow-up study.||participants|||Number
768161|NCT00702234|Primary|Number of Expectant Mothers Experiencing Adverse Events (AEs)|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|From approximately 10 weeks after fresh ET in base study P05714 up to birth of infant (up to approximately 6 months)|Follow-up safety analysis was performed on expectant mothers who received corifollitropin alfa in base study P05714 (NCT00696878) and who enrolled in the follow-up study.||participants|||Number
768162|NCT00702234|Primary|Percentage of Women With Ongoing Pregnancy After a Corifollitropin Alfa COS Cycle in Base Study and ≥1 Live Born Infant During Follow-up (Live Birth Rate)|The live birth rate was defined as the number of participants who had an ongoing pregnancy after a corifollitropin alfa COS cycle in base study P05714 (NCT00696878) and who had at least one live born infant during follow-up, divided by the number of participants treated in the base study. For this analysis, it was assumed that any participants with ongoing pregnancy after a COS cycle in base study who did not enroll in follow-up study P05715 had no live born infants.|Up to approximately 32 months after first dose of corifollitropin alfa in base study P05714 (NCT00696878)|Participants administered corifollitropin alfa in base study P05714 (NCT00696878)||percentage of participants|||Number
768163|NCT00702273|Secondary|Percentage of Participants in Follow up Trial With an Ongoing Pregnancy|An ongoing pregnancy is the presence of at least one fetus with heart activity at least 10 weeks after embryo transfer or confirmed at live birth. Ongoing pregnancies were calculated per attempt, meaning if any stage of IVF treatment was not achieved, zero values were imputed.|After one or more FTET, assessed at least 10 weeks after embryo transfer or at live birth (up to 1 year)|Participants enrolled in P05716 Follow Up study, that had an embryo transfer in the respective cycle.||Percentage of participants|||Number
768164|NCT00702273|Secondary|Percentage of Participants in Follow up Trial With a Vital Pregnancy|A vital pregnancy is the presence of at least one fetus with heart activity. Vital pregnancies were calculated per attempt, meaning if any stage of IVF treatment was not achieved, zero values were imputed.|After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)|Participants enrolled in P05716 Follow Up study, that had an embryo transfer in the respective cycle.||Percentage of participants|||Number
768165|NCT00702273|Secondary|Percentage of Participants in Follow up Trial With a Clinical Pregnancy|A clinical pregnancy is the presence of at least gestational sac or confirmed by live birth. Clinical pregnancies were calculated per attempt, meaning if any stage of in vitro fertilization (IVF) treatment was not achieved, zero values were imputed.|After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)|Participants enrolled in P05716 Follow Up study, that had an embryo transfer in the respective cycle.||Percentage of participants|||Number
768166|NCT00702273|Secondary|Percentage of Participants in Follow up Trial With an Ectopic Pregnancy|An ectopic pregnancy is where the embryo implants outside the uterus. Ectopic pregnancies were calculated per total number of participants started in FTET.|After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)|Participants enrolled in P05716 Follow Up study.||Percentage of participants|||Number
768167|NCT00702273|Secondary|Percentage of Participants in Follow up Trial With a Miscarriage Per Vital Pregnancy|Miscarriages were calculated per vital pregnancy, meaning the presence of at least one fetus with heart activity.|After one or more FTET cycles, up to day of miscarriage (up to 1 year)|Participants enrolled in P05716 Follow Up study that had a vital pregnancy.||Percentage of participants|||Number
768168|NCT00702273|Secondary|Percentage of Participants in Follow up Trial With a Miscarriage Per Clinical Pregnancy|Miscarriages were calculated per clinical pregnancy, meaning the presence of at least one gestational sac or confirmed by live birth.|After one or more FTET cycles, up to day of miscarriage (up to 1 year)|Participants enrolled in P05716 Follow Up study that had a clinical pregnancy.||Percentage of participants|||Number
768169|NCT00702273|Primary|Percentage of Participants With an Ongoing Pregnancy (Cumulative Ongoing Pregnancy Rate)|An ongoing pregnancy is the presence of at least one fetus with heart activity at least 10 weeks after embryo transfer or confirmed by live birth.The cumulative ongoing pregnancy rate is 100 times the number of participants with an ongoing pregnancy either immediately after embryo transfer in base Trial P05787 (NCT00696800), or after one or more FTET cycles in follow-up Trial P05716 following cryopreservation, divided by the total number of participants that started treatment in base Trial P05787 (NCT00696800). Participants who did not have cryopreserved embryos, or embryo transfers in the FTET cycle(s), were considered 'not pregnant'.|Up to 1 year after embryo transfer in base trial P05787 (NCT00696800), and FTET cycles in follow up trial|ITT group from base trial P05787, consisting of randomized participants who were treated with Corifollitropin Alfa or recFSH.||Percentage of participants|||Number
768170|NCT00694473|Secondary|Navigator CGM Accuracy by Category|Mean Absolute Relative Difference (MARD) between the Navigator CGM and reference blood glucose values by category (1, Neurosurgery; 2, Cardiac Surgery; 3, Hypotensive/Vasopressor; 4, Edema; 5, None of the Above)|72 hours|MARD by category (1, Neurosurgery; 2, Cardiac Surgery; 3, Hypotensive/Vasopressor; 4, Edema; 5, None of the Above)||percent absolute relative difference||Standard Deviation|Mean
768171|NCT00694473|Secondary|Percentage of Readings in Different Blood Sugar Ranges as Shown by Point of Care Testing:|"Percentage of readings in different blood sugar ranges as shown by point of care testing:
< 60 mg/dl 61-120 mg/dl 121-180 mg/dl 181-240 lmg/dl >240 mg/dl"|72 hours|||percentage of readings|||Number
768172|NCT00694473|Secondary|Sensitivity and Specificity of Navigator Projected High Blood Sugar Alarm Criteria Calculated for Events Defined by a High Reference BG Value (> 250 mg/dl)||72 hours|This measure was not calculated as we did not have sufficient data to calculate sensitivity and inappropriate BG check times to calculate specificity and few trends towards hyperglycemia|||||
768180|NCT00694564|Secondary|Safety||0, 2 weeks, 1 month, 2 month||||||
768181|NCT00694564|Primary|Wong-Baker FACES Pain Rating Scale|We scored the Wong-Baker Pain Rating Scale numerically on a scale of 0 (no pain) to 4 (worst pain).|0, 2 weeks, 1 month, 2 months|||units on a scale||Standard Deviation|Mean
768182|NCT00694603|Secondary|Progression-free Survival||From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months|||months||95% Confidence Interval|Median
768183|NCT00694603|Primary|Response Rate by CT Scan Using RECIST Criteria||8 weeks|The trial used a Simon two-stage design, which enrolled 18 pts in the first stage and was to proceed to enroll an additional 28 evaluable patients if 1 or more response was observed in the first group. This design provided a 57% chance of early termination if the true response rate was <3%. PFSand OS were calculated using the Kaplan-Meier method.||participants|||Number
768184|NCT00695019|Post-Hoc|Normalization of Platelets|Percentage of participants with a low platelet count at baseline who had a normal platelet count at the end of the study|48 weeks|Participants with a baseline platelet count below 150 who were evaluable for response at week 48 were included in the analysis||percentage of participants|||Number
768185|NCT00695019|Secondary|Change in Fibrotest Score|Change in fibrotest score from baseline to week 48|48 weeks|||units on a scale||Standard Deviation|Mean
768186|NCT00695019|Secondary|Change in Social Functioning|"Change in the Social Functioning domain of the SF-36 quality-of-life questionnaire from baseline to week 48
Social Functioning (SF) scores range from 0-100, with lower scores indicating that health/emotional problems have had a greater negative impact on social activities, compared to higher scores. SF scores are calculated using a proprietary algorithm based on responses to questions #6 and #10 on the SF-36, which are 5-point likert scales about the extent to which, and the amount of time with which physical or emotional problems have interfered with social activities."|48 weeks|Intent-to-treat||change in score||Standard Deviation|Mean
768187|NCT00695019|Primary|Relapse Rate|"Percentage of participants with a positive seum HCV RNA level at any post-baseline evaluation
Serum HCV RNA was tested using a commercially available real-time polymerase-chain-reaction (PCR) assay kit (Roche Cobas TaqMan HCV assay kit) with a limit of detection of 15 IU/ml."|48 weeks|Intent-to-treat||percentage of participants|||Number
768188|NCT00695019|Secondary|Change in Serum ALT|Change in Serum ALT concentration from baseline to week 48|48 weeks|Intent-to-treat||U/L||Standard Deviation|Mean
768189|NCT00695019|Secondary|Change in Serum HCV RNA Concentration|Change in serum HCV RNA concentration (log10 IU) from baseline to week 48|48 weeks|Intent-to-treat population||log10 IU||Standard Deviation|Log Mean
768190|NCT00695019|Secondary|Normalization of ALT|Percentage of participants with a normal serum ALT level at the end of the study|48 weeks|Intent-to-treat||percentage of participants|||Number
768191|NCT00695019|Secondary|Sustained Virologic Response Rate|Percentage of participants who remained HCV RNA negative throughout the study|48 weeks|Intent-to-treat||percentage of participants|||Number
768192|NCT00695097|Primary|Change in Biopsy Cell Densities From Baseline to Follow-up|Follow-up biopsy was done 3-6 months after study treatment. Study follow-up monthly for 1 year.|1 year|5 Rituximab participants and 4 Control participants provided both baseline and follow-up biopsies for analysis. 6 participants withdrew their consent.||cells/mm^3||Standard Deviation|Mean
768193|NCT00695136|Primary|Change in Percentage of Time That Subjects With Autism Spend in REM Sleep.||1 month (from baseline to 1.25 mg dose)|||percentage of REM sleep||Standard Error|Mean
768194|NCT00695188|Secondary|HAQ (Health Assessment Questionnaire)||16 weeks||||||
768195|NCT00695188|Primary|DAS-28 (Disease Activity Score in 28 Joints)|"DAS stands for Disease Activity Score and is a measure of the activity of rheumatoid arthritis. In Europe the DAS is the recognized standard in research and clinical practice.
The following parameters are included in the calculation:
Number of joints tender to the touch (TEN)
Number of swollen joints (SW)
Erythrocyte sedimentation rate (ESR)
Patient assessment of disease activity (VAS; mm)
The DAS-28 is evaluated using a scale:
0 - 3.2: low disease activity 3.2 - 5.1: moderate disease activity > 5.1: severe disease activity"|16 weeks|||Units on a Scale||Standard Deviation|Mean
768196|NCT00695292|Secondary|Efficacy and Safety Analysis Will be Conducted in Patients With Progressive Disease or Irreversible Toxicity on Chemotherapy Alone Who Elect to Receive Sunitinib Alone Until Progressive Disease or Irreversible Toxicity.||18 months||||||
768197|NCT00695292|Secondary|Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment|Objective benefit is defined as substantial (30% or greater) shrinkage in tumor volume per RECIST 1.0.|18 months|The original study design administered sunitinib concurrently with irinotecan/carboplatin. After the first three patients enrolled experienced severe myelosuppression, the treatment plan was modified to delay sunitinib until after completion of combination therapy. Only patients treated under the revised plan are included in the results analysis.||percentage of participants||95% Confidence Interval|Number
768198|NCT00695292|Primary|One-year Survival, The Percentage of Patients Who Are Alive One Year After Completing Protocol Treatment||18 months|The original study design administered sunitinib concurrently with irinotecan/carboplatin. After the first three patients enrolled experienced severe myelosuppression, the treatment plan was modified to delay sunitinib until after completion of combination therapy. Only patients treated under the revised plan are included in the results analysis.||percentage of participants|||Number
771938|NCT00731094|Secondary|Weight|Weight in kilograms measured at Month 12|Month 12|||kg||Standard Deviation|Mean
768201|NCT00695396|Secondary|RBC Transfusion From Day 29 Through the End of Study|incidence of participants who received at least 1 RBC transfusion from Day 29 through the end of study (approximately 48 weeks).|Day 29 through the end of study (approximately 48 weeks)|The intent-to-treat (ITT) population was defined as all participants randomly assigned to a treatment group, regardless of whether they received any treatment.||participants|||Number
768202|NCT00695396|Primary|Red Blood Cell (RBC) Transfusion|Incidence of participants who received at least 1 Red Blood Cell (RBC) transfusion during the study (from randomization through the end of study)|Approximately 48 weeks|The intent-to-treat (ITT) population was defined as all participants randomly assigned to a treatment group, regardless of whether they received any treatment.||participants|||Number
768203|NCT00695435|Secondary|Tobramycin Tear Concentration Area Under the Curve (AUC)|Trapezoidal AUC was calculated from 2 to 18 minutes.|2 to 18 minutes post administration|||min*ug/mL||Standard Deviation|Mean
768204|NCT00695435|Primary|Tobramycin Tear Concentration Cmax (Maximum Concentration)|Tear samples were collected to measure tobramycin concentrations at 2, 4, 6, 12, and 18 minutes post-drop instillation in each subject’s right eye for each treatment period.|2, 4, 6, 12, and 18 minutes|||µg/mL||Standard Deviation|Mean
768205|NCT00695500|Other Pre-specified|BOLD Response to Alcohol Cue|Percent BOLD signal change during Alcohol Food Incentive Delay Task (Alcohol - Neutral)|fMRI session following 2 weeks of treatment|sample that completed the assessment||Percent Signal Change||Standard Error|Mean
768206|NCT00695500|Secondary|Alcohol Urges|"Peak Alcohol Urge Questionnaire Score during IV alcohol self-administration. Scale: Alcohol Urge Questionnaire. Contains 8 items, each item scored on a likert scale from 1 to 7.
Range: Total scores range between 8 and 64. Higher scores indicate higher urges for alcohol."|2.5 hr session following 3 weeks of treatment|sample that completed the assessment||Units on a scale||Standard Error|Mean
768207|NCT00695500|Primary|Alcohol Consumption|Peak Breath Alcohol Concentration during IV alcohol self-administration|2.5 hr session following 3 weeks of treatment|sample that completed the assessment||mg/%||Standard Error|Mean
768208|NCT00695565|Secondary|Change in Blood Pressure From Baseline to Week 12|Systolic and Diastolic Blood Pressure were measured at clinic visits. This outcome assesses the change in blood pressure from Baseline to Week 12 of treatment.|Baseline and Week 12|ITT (Intent-to-Treat)||mmHg||Standard Deviation|Mean
768209|NCT00695565|Secondary|Clinician Global Impression of Change (CGIC) at Week 12|At Week 12, the Investigator was asked to independently rate the subject's total improvement relative to Baseline, whether or not, in their judgement, it was due entirely to study drug treatment or not. Answer choices were: (+3) very much improved, (+2) much improved, (+1) minimally improved, (0) no change, (-1) minimally worse, (-2) much worse, (-3) very much worse.|Week 12|All subjects with a CGIC score were analyzed.||percentage of subjects|||Number
768210|NCT00695565|Secondary|Patient Global Impression of Change (PGIC) at Week 12|At Week 12 the subject was asked to rate their total improvement relative to Baseline, whether or not, in their judgement, it was due entirely to study drug treatment or not. Answer choices were: (+3) very much improved, (+2) much improved, (+1) minimally improved, (0) no change, (-1) minimally worse, (-2) much worse, (-3) very much worse.|Week 12|All subjects with a PGIC score were analyzed.||percentage of subjects|||Number
768211|NCT00695565|Secondary|Change From Baseline to Week 12 in the McGill Pain Questionnaire (Short Form) Total Score|The McGill Pain Questionnaire asks subjects to rate 15 different kinds of pain, each on a scale of 0 to 3 (0=None, 1=Mild, 2=Moderate, 3=Severe). The total score is a sum of the individual ratings and has a range from 0 to 45, where higher numbers indicate more pain. The 15 types of pain assessed are throbbing, shooting, stabbing, sharp, cramping, gnawing, hot-burning, aching, heavy, tender, splitting, tiring-exhausting, sickening, fearful, and punishing-cruel. This scale was completed at the Baseline and Week 12 clinic visits. The change from Baseline is calculated as the Week 12 total score minus the Baseline total score, so greater negative numbers indicate more improvement (pain relief).|Baseline and Week 12|One subject in the active Clonidine Gel group was lost to follow-up before Baseline pain scores were confirmed and before any post-baseline efficacy evaluations were performed. This subject was excluded from the efficacy analyses.||units on a scale||Standard Deviation|Mean
768212|NCT00695565|Secondary|Change From Baseline to Week 12 in the Anxiety Score of the Hospital Anxiety and Depression Scale (HADS)|The HADS was completed at the Baseline and Week 12 clinic visits. The Anxiety Score component of the HADS includes 7 questions, each with 4 possible answer choices (rated 0 to 3). The composite score is created by adding the scores of the 7 individual questions. A score of 0 to 7 is Normal, 8-10 indicates Mild Anxiety, 11-14 indicates Moderate Anxiety, and 15-21 indicates Severe Anxiety. The change from Baseline is calculated as the Week 12 composite score minus the Baseline composite score.|Baseline and Week 12|One subject in the active Clonidine Gel group was lost to follow-up before Baseline pain scores were confirmed and before any post-baseline efficacy evaluations were performed. This subject was excluded from the efficacy analyses.||units on a scale||Standard Deviation|Mean
768213|NCT00695565|Secondary|Change From Baseline to Week 12 in the Depression Score of the Hospital Anxiety and Depression Scale (HADS)|The HADS was completed at the Baseline and Week 12 clinic visits. The Depression Score component of the HADS includes 7 questions, each with 4 possible answer choices (rated 0 to 3). The composite score is created by adding the scores of the 7 individual questions. A score of 0 to 7 is Normal, 8-10 indicates Mild Depression, 11-14 indicates Moderate Depression, and 15-21 indicates Severe Depression. The change from Baseline is calculated as the Week 12 composite score minus the Baseline composite score.|Baseline and Week 12|One subject in the active Clonidine Gel group was lost to follow-up before Baseline pain scores were confirmed and before any post-baseline efficacy evaluations were performed. This subject was excluded from the efficacy analyses.||units on a scale||Standard Deviation|Mean
768214|NCT00695565|Secondary|Change From Baseline to Week 12 in Overall Quality of Sleep (Chronic Pain Sleep Inventory)|Subjects rated overall quality of sleep over the past week using a 100 mm Visual Analog Scale (VAS) where 100=Excellent and 0=Very Poor. This scale was completed during clinic visits. Change from Baseline is a positive value where quality of sleep improved.|Baseline and Week 12|One subject in the active Clonidine Gel group was lost to follow-up before Baseline pain scores were confirmed and before any post-baseline efficacy evaluations were performed. This subject was excluded from the efficacy analyses.||units on a scale||Standard Deviation|Mean
771939|NCT00731094|Secondary|Weight|Weight in kilograms at measured at Month 6|Month 6|||kg||Standard Deviation|Mean
771940|NCT00731094|Secondary|Weight|Weight in kilograms (kg) measured at Month 0|Month 0|||kg||Standard Deviation|Mean
768215|NCT00695565|Secondary|Change From Baseline in the Brief Pain Inventory Functional Interference Scale at Week 12; mLOCF Imputation|"The Brief Pain Inventory was completed by the subject at clinic visits. The Functional Interference Scale (of 0 to 70) is a composite score that measures the degree to which pain interferes with mood, walking, work, relationships, sleep, general activity, and enjoyment of life. The composite score is a sum of the seven individual question scores. Each individual question is rated in reference to pain over the past 24 hours on a scale of 0 to 10, where 0 indicates that pain does not interfere and 10 indicates that pain completely interferes with that function, so lower scores represent better outcomes on this scale.
The change in functional interference is represented as Week 12 minus Baseline, so greater negative numbers represent more improvement."|Baseline and Week 12|One subject in the active Clonidine Gel group was lost to follow-up before Baseline pain scores were confirmed and before any post-baseline efficacy evaluations were performed. This subject was excluded from the efficacy analyses.||units on a scale||Standard Deviation|Mean
768216|NCT00695565|Secondary|Change From Baseline in the Brief Pain Inventory (BPI) Severity Scale at Week 12; mLOCF Imputation|"The Brief Pain Inventory was completed by the subject at clinic visits. The Severity Scale (of 0 to 40) is a composite score, which is the sum of the individual ratings for worst pain, least pain, average pain, and current pain. Each individual question is rated on a scale of 0 to 10, where 0 indicates No Pain and 10 indicates Pain as bad as you can imagine. The change in pain severity is represented as Week 12 minus Baseline, so greater negative numbers represent greater improvement (pain relief)."|Baseline and Week 12|One subject in the active Clonidine Gel group was lost to follow-up before Baseline pain scores were confirmed and before any post-baseline efficacy evaluations were performed. This subject was excluded from the efficacy analyses.||units on a scale||Standard Deviation|Mean
768217|NCT00695565|Secondary|Percentage of Subjects Who Experience at Least 50% Reduction in Average Daily Pain From Baseline; mLOCF Imputation|"Pain in the feet was scored daily at bedtime by the subject on a 0-10 numeric pain rating scale (NPRS). Subjects were asked to record average pain in the feet over the past 24 hours. A score of 0 indicated no pain and a score of 10 was worst possible pain."|Baseline (average of Days -7 to -1) and Week 12 (average of Days 78 to 84)|One treated subject had no recorded scores and could not be included. Imputation was a modified LOCF (LOCF for subjects who discontinued early, except if withdrawal was associated with an adverse event (AE) potentially related to study medication, in which case BOCF was used). Additional BOCF analyses have been published (Pain 2012, see citation).||percentage of subjects|||Number
768218|NCT00695565|Secondary|Percentage of Subjects Who Experience at Least 30% Reduction in Average Daily Pain From Baseline; mLOCF Imputation|"Pain in the feet was scored daily at bedtime by the subject on a 0-10 numeric pain rating scale (NPRS). Subjects were asked to record average pain in the feet over the past 24 hours. A score of 0 indicated no pain and a score of 10 was worst possible pain."|Baseline (average of Days -7 to -1) and Week 12 (average of Days 78 to 84)|One treated subject had no recorded scores and could not be included. Imputation was a modified LOCF (LOCF for subjects who discontinued early, except if withdrawal was associated with an adverse event (AE) potentially related to study medication, in which case BOCF was used). Additional BOCF analyses have been published (Pain 2012, see citation).||percentage of subjects|||Number
768219|NCT00695565|Secondary|Change From Baseline to Week 12 in the Worst Daily Pain NPRS Score; mLOCF Imputation|"Pain in the feet was scored daily at bedtime by the subject on a 0-10 numeric pain rating scale. Subjects were asked to record the worst pain in their feet over the past 24 hours. A score of 0 indicated no pain and a score of 10 was worst possible pain. The change in pain is represented as Week 12 minus Baseline, so greater negative numbers represent greater improvement (greater pain relief)."|Baseline (average of Days -7 to -1) and Week 12 (average of Days 78 to 84)|One treated subject had no recorded scores and could not be included. Imputation was a modified LOCF (LOCF for subjects who discontinued early, except if withdrawal was associated with an adverse event (AE) potentially related to study medication, in which case BOCF was used). Additional BOCF analyses have been published (Pain 2012, see citation).||units on a scale||Standard Deviation|Mean
768220|NCT00695565|Secondary|Change From Baseline in Average Daily Pain NPRS Score for Each Week of Treatment; mLOCF Imputation|"Pain in the feet was scored daily at bedtime by the subject on a 0-10 numeric pain rating scale (NPRS). Subjects were asked to record average pain in the feet over the past 24 hours. A score of 0 indicated no pain and a score of 10 was worst possible pain. A weekly average was calculated from the daily scores for each week. The change in pain is represented as the average weekly score minus Baseline, so greater negative numbers represent more improvement (more pain relief)."|Baseline (average of Days -7 to -1) and Weeks 1 through 12 (weekly averages)|One treated subject had no recorded scores and could not be included. Imputation was a modified LOCF (LOCF for subjects who discontinued early, except if withdrawal was associated with an adverse event (AE) potentially related to study medication, in which case BOCF was used). Additional BOCF analyses have been published (Pain 2012, see citation)||units on a scale||Standard Deviation|Mean
768221|NCT00695565|Primary|Change From Baseline to Week 12 in the Average Daily Pain NPRS (Numeric Pain Rating Scale) Score; mLOCF Imputation|"Pain in the feet was scored daily at bedtime by the subject on a 0-10 numeric pain rating scale (NPRS) through Day 84. Subjects were asked to record average pain in the feet over the past 24 hours. A score of 0 indicated no pain and a score of 10 was worst possible pain.
The change in pain is represented as Week 12 minus Baseline, so greater negative numbers represent more improvement (more pain relief)."|Baseline (average of Days -7 to -1) and Week 12 (Average of Days 78 to 84)|One treated subject had no recorded scores and could not be included. Imputation was mLOCF (modified Last Observation Carried Forward): LOCF for subjects who discontinued early, except if withdrawal was associated with an adverse event (AE) potentially related to study medication (in which case Baseline Observation Carried Forward (BOCF) was used).||units on a scale||Standard Deviation|Mean
768222|NCT00695669|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs)|A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or resulted in a congenital anomaly/birth defect in the offspring of a study subject.|From Day 0 to 182|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine and for whom any post-vaccination data were available.||Subjects|||Number
773376|NCT00738023|Primary|Changes in Systolic Blood Pressure During Initial Intralipid Infusion|Systolic blood pressure change from baseline during an 48-hour intralipid infusion|Baseline, 48 hours|||mmHg||Standard Error|Mean
768223|NCT00695669|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within the 51-day follow-up period (Days 0-50) after first vaccination.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine and for whom any post-vaccination data were available.||Subjects|||Number
768224|NCT00695669|Secondary|Number of Subjects With Medically Attended Adverse Events (MAEs).|A MAE was defined as any unsolicited symptom that received medical attention such as hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason.|From Day 0 to 182|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine and for whom any post-vaccination data were available.||Subjects|||Number
768225|NCT00695669|Secondary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms were fatigue, headache, joint pain at other location (joint pain), muscle aches, shivering, sweating and fever. Fever was defined as oral temperature ≥ 38 degrees Celsius (°C). Any = occurrence of any solicited general symptoms regardless of intensity grade or relationship to vaccination.|Within the 7-day follow-up period (Days 0-6) after any vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine and for whom any post-vaccination data were available and had the symptom sheet completed.||Subjects|||Number
768226|NCT00695669|Secondary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any solicited local symptoms regardless of their intensity grade.|Within the 7-day follow-up period (Days 0-6) after any vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine and for whom any post-vaccination data were available and had the symptom sheet completed.||Subjects|||Number
768227|NCT00695669|Secondary|Number of Subjects With a Vaccine Response of MN Assessed Antibodies for the Flu A/Turkey/Turkey/1/2005 (TURK) Strain of Influenza Disease.|Subjects with vaccine response were defined as vaccinated subjects who had either a pre-vaccination titer < 1:28 and a post vaccination titer ≥ 1:56 or a pre-vaccination titer ≥ 1:28 and at least a four-fold increase in post-vaccination titer.|At Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.||Subjects|||Number
768228|NCT00695669|Secondary|Number of Subjects With a Vaccine Response of MN Assessed Antibodies for Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.|Subjects with a vaccine response were defined as vaccinated subjects who had either a pre-vaccination titer < 1:28 and a post vaccination titer ≥ 1:56 or a pre-vaccination titer ≥ 1:28 and at least a four-fold increase in post-vaccination titer.|At Day 42|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.||Subjects|||Number
768229|NCT00695669|Secondary|Number of Subjects With a Vaccine Response of MN Assessed Antibodies for Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.|Subjects with a vaccine response were defined as vaccinated subjects who had either a pre-vaccination titer < 1:28 and a post vaccination titer ≥ 1:56 or a pre-vaccination titer ≥ 1:28 and at least a four-fold increase in post-vaccination titer.|At 7, 14 and 21 days after the second dose|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.||Subjects|||Number
768230|NCT00695669|Secondary|Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 4 Group.|At Days 0, 7, 14, 21, 42 and 182.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.||titers||95% Confidence Interval|Geometric Mean
768231|NCT00695669|Secondary|Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 3 Group.|At Days 0, 7, 14, 21, 28, 42 and 182.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.||titers||95% Confidence Interval|Geometric Mean
768232|NCT00695669|Secondary|Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 2 Group.|At Days 0, 14, 21, 28, 35, 42 and 182.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.||titers||95% Confidence Interval|Geometric Mean
768290|NCT00702377|Primary|Tear Break-up Time|Tear breakup time is the time interval between a blink and the development of a dry spot in the tear film. Less than 10 seconds is abnormal. Dry spot is visible after fluorescein staining when viewed under a slit-lamp.|Day 0, Day 7, Day 14, Day 28, and Day 42|||seconds||Standard Deviation|Mean
773377|NCT00738049|Secondary|Change During Darusentan Treatment in the Coronary Flow Reserve (CFR)|CFR is calculated as the unitless ratio between hyperemic to resting flow|0, 2, 4, and 6 weeks|||no units||Standard Deviation|Mean
768233|NCT00695669|Secondary|Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 1 Group.|At Days 0, 21, 28, 35, 42 and 182.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.||titers||95% Confidence Interval|Geometric Mean
768234|NCT00695669|Secondary|Geometric Mean Fold-rise (GMFR) for the A/Indonesia/5/2005 (H5N1), Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.|The GMFR is presented as the GMT ratio between GMTs at Day 42/182 and at Day 0.|At Days 0, 42 and 182.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.||Fold increase||95% Confidence Interval|Geometric Mean
768235|NCT00695669|Secondary|Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) reciprocal hemagglutination inhibition (HI) titer < 1:10 and a post-vaccination (at Day 14 post Dose 2) reciprocal titer ≥ 1:40 or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a four-fold increase in post-vaccination (at Day 14 post Dose 2) titer.|At Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.||Subjects|||Number
768236|NCT00695669|Secondary|Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1), Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) reciprocal HI titer < 1:10 and a post-vaccination (at Day 14 post Dose 2) reciprocal titer ≥ 1:40 or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a four-fold increase in post-vaccination (at Day 14 post Dose 2) titer.|At Day 42|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.||Subjects|||Number
768237|NCT00695669|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 4 Group.|At Days 0, 7, 14, 21, 42 and 182.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.||titers||95% Confidence Interval|Geometric Mean
768238|NCT00695669|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 3 Group.|At Days 0, 7, 14, 21, 28, 42 and 182.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.||titers||95% Confidence Interval|Geometric Mean
768239|NCT00695669|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 2 Group.|At Days 0, 14, 21, 28, 35, 42 and 182.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.||titers||95% Confidence Interval|Geometric Mean
768240|NCT00695669|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 1 Group.|At Days 0, 21, 28, 35, 42 and 182.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.||titers||95% Confidence Interval|Geometric Mean
768241|NCT00695669|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 4 Group.|At Days 0, 7, 14, 21, 42 and 182.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.||titers||95% Confidence Interval|Geometric Mean
768242|NCT00695669|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 3 Group.|At Days 0, 7, 14, 21, 28, 42 and 182.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.||titers||95% Confidence Interval|Geometric Mean
768426|NCT00703677|Secondary|PSP-Quality of Life Scale (QoL):Change From Baseline|The PSP-QoL Scale is an instrument designed to assess mental and physical aspects of quality of life specifically in patients with PSP. Subjects will be assessed at baseline and Weeks 12, 20, and 28.|28 weeks||||||
768243|NCT00695669|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 2 Group.|At Days 0, 14, 21, 28, 35, 42 and 182.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.||titers||95% Confidence Interval|Geometric Mean
768244|NCT00695669|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 1 Group.|At Days 0, 21, 28, 35, 42 and 182.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.||titers||95% Confidence Interval|Geometric Mean
768245|NCT00695669|Primary|Number of Seroprotected Subjects Against 3 Strains the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.|A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40.|At Day 0 and at Day 14 post Dose 2|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.||Subjects|||Number
768246|NCT00695669|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The Confidence Interval for this outcome was 98.75%.|At Day 0 and at Day 14 post Dose 2|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.||titers||95% Confidence Interval|Geometric Mean
768247|NCT00695669|Primary|Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) reciprocal hemagglutination inhibition (HI) titer less than (<) 1:10 and a post-vaccination (at Day 14 post Dose 2) reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a four-fold increase in post-vaccination (at Day 14 post Dose 2) titer.|At Day 14 post Dose 2|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.||Subjects|||Number
768248|NCT00702299|Secondary|Pharmacokinetics (Mean Cmax, ug/mL)for Different Dosages of Pemetrexed|Cmax levels were found through plasma collected between 0.5 to 4 hours and at 24 hours after initiation of intraperitoneal administration|18 months|||ug/mL||Standard Deviation|Mean
768249|NCT00702299|Secondary|Overall Survival||Average Length of follow-up 788 days|||Days||Full Range|Median
768250|NCT00702299|Secondary|Progression-free Survival at 18 Months as Assessed by Cancer Antigen 125|Progression was evaluated with posttreatment CT scans and measured changes in cancer antigen 125 levels 6 months after the initiation of the treatment regimen, or within one month after discontinuation of treatment if stopped early. Cancer antigen 125 response in evaluable patients (N=13) was analyzed using the modified Gynecologic Cancer Intergroup (GCIG) criteria. There was one evaluable patient by Response Evaluation Criteria in Solid Tumors(RECIST) criteria|18 months|||% of participants|||Number
768251|NCT00702299|Primary|Patients Experienced Grade >=3 Toxicity at Dose Level 5 (1,000 mg/m2 IP Pemetrexed)|Toxicity was assessed by NCI Common Toxicity Criteria for Adverse Effects v3.0|18 months|||participants|||Number
768252|NCT00702299|Primary|Patients That Completed at Least 6 Courses of Therapy of Pemetrexed Along With Day 2 i.p. Cisplatin (75 mg/m2) and Day 8 i.p. Paclitaxel (60 mg/m2)at the Determined Maximum Tolerated Dose|If none of the initial 3 patients on a dose level experienced a dose-limiting toxicity (DLT) after the first cycle of therapy, then the dose was escalated to the next level. If 2 or more patients on any dose level experienced a DLT, then the Maximum Tolerance Dose (MTD) would be determined to be the next lower dose level.|18 months|||% of participants|||Number
768253|NCT00702299|Primary|Maximum-tolerated Dose of Pemetrexed With a Day 2 i.p. Cisplatin (75 mg/m2) and Day 8 i.p. Paclitaxel (60 mg/m2)|If none of the initial 3 patients on a dose level experienced a dose-limiting toxicity (DLT) after the first cycle of therapy, then the dose was escalated to the next level. If 2 or more patients on any dose level experienced a DLT, then the maximum tolerated dose would be determined to be the next lower dose level.|18 months|||mg/m2|||Number
768254|NCT00702325|Secondary|Perception of Onset of Medication Effect at First Week of Treatment Assessed by Number of Participants Who Agreed With Item 5 on the Onset of Effect Questionnaire (OEQ)|Diary assessment of participants age 12 years and older and 18 years and older who agreed with OEQ Item 5 at first week of treatment - During the past week, you were satisfied with how quickly you felt your study medication began to work.|1 week|||Participants|||Number
768255|NCT00702325|Secondary|Perception of Onset of Medication Effect at First Week of Treatment Assessed by Number of Participants Who Agreed With Item 2 on the Onset of Effect Questionnaire (OEQ)|Diary assessment of participants age 12 years and older and 18 years and older who agreed with OEQ Item 2 at first week of treatment - During the past week, you could feel your medication begin to work right away|1 week|||Participants|||Number
768256|NCT00702325|Secondary|Perception of Onset of Medication Effect at Last Week of Treatment Assessed by Number of Participants Who Agreed With Item 5 on the Onset of Effect Questionnaire (OEQ)|Diary assessment of participants age 12 years and older and 18 years and older who agreed with OEQ Item 5 at last week of treatment - During the past week, you were satisfied with how quickly you felt your study medication began to work.|12 week|||Participants|||Number
768291|NCT00702403|Secondary|Relapse|The proportion of patients with hematologic, cytogenetic or molecular relapse of BCR/ABL-positive leukemia|1 and 3 years|Proportion of patients with hematologic, cytogenetic or molecular relapse of BCR/ABL-positive leukemia among those who did not die from non-relapse causes during the first year, and first 3-years after transplant.||Participants|||Count of Participants
768257|NCT00702325|Secondary|Change From Baseline to Last Week of Treatment in Scores on the Asthma Impact Survey (AIS)|There are 6 questions in the survey, and each question has 5 responses (total score for each question can range from 6 to 13). Responses to the 6 questions were added to yield a total score that ranged from 36 to 78. Scoring is based on a norm-based method. Higher AIS scores indicated more asthma impact and poorer quality of life; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period.|Baseline to 12 weeks|||Scores on a scale||Standard Deviation|Mean
768258|NCT00702325|Secondary|Proportion of Participants Who Reported on the Asthma Control Test (ACT) That Their Asthma Was Controlled at the Last Week of Treatment|There are 5 questions in the survey, and each question has 5 responses (total score for each question can range from 1 to 5). To score the survey, responses to the 5 questions are added to yield a total score that ranges from 5 (poor control of asthma control) to 25 (complete control of asthma). Score of 20 or higher was indicative of well-controlled asthma.|12 weeks|||Proportion of Participants|||Number
768259|NCT00702325|Secondary|Change From Baseline to End of Treatment in Overall Score on the Asthma Quality of Life Questionnaire-Standardized (AQLQ[S])|Mean change in overall score at end of treatment for participants age 17 years and older (scores ranged from 1 to 7, with higher scores indicating better quality of life); mean change from baseline (Visit 3) value to average value recorded at visits during treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Scores on a scale||Standard Deviation|Mean
768260|NCT00702325|Secondary|Perception of Onset of Medication Effect at Last Week of Treatment Assessed by Number of Participants Who Agreed With Item 2 on the Onset of Effect Questionnaire (OEQ)|Diary assessment of participants age 12 years and older and 18 years and older who agreed with OEQ Item 2 at last week of treatment - During the past week, you could feel your medication begin to work right away|12 week|||Participants|||Number
768261|NCT00702325|Secondary|Change From Baseline to the Average for Asthma-control Days Averaged Over the Treatment Period|Diary assessment of number (percent) of asthma-control days (defined as days that were free of symptoms and nighttime and daytime rescue medication use); mean change from baseline (Visit 3) value to average value recorded at visits during treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||percentage of days||Standard Deviation|Mean
768262|NCT00702325|Secondary|Change From Baseline in Asthma Symptom-free Days Averaged Over the Treatment Period|Diary assessment of number (percent) of days free from asthma symptoms by ICS dose at entry; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||percentage of days||Standard Deviation|Mean
768263|NCT00702325|Secondary|Change From Baseline to the Average in Rescue Medication-free Days Averaged Over the Treatment Period|Diary assessment of total (percent) days free from rescue medication use for asthma symptoms relief; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||percentage of days||Standard Deviation|Mean
768264|NCT00702325|Secondary|Change From Baseline to the Average in Daytime Medication Use Averaged Over the Treatment Period|Diary assessment of total daytime puffs of rescue medication used for asthma symptoms relief; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Puffs/day||Standard Deviation|Mean
768265|NCT00702325|Secondary|Change From Baseline to the Average in Nighttime Rescue Medication Use Averaged Over the Treatment Period|Diary assessment of total nighttime puffs of rescue medication used for asthma symptoms relief; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Puffs/day||Standard Deviation|Mean
768266|NCT00702325|Secondary|Change From Baseline to the Average in Total Rescue Medication Use Averaged Over the Treatment Period|Diary assessment of total daily puffs of rescue medication used for asthma symptoms relief; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Puffs/day||Standard Deviation|Mean
768267|NCT00702325|Secondary|Change From Baseline in Awakening-free Nights Averaged Over the Treatment Period|Diary assessment of number of nights free from awakenings due to asthma; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Number of nights||Standard Deviation|Mean
768268|NCT00702325|Secondary|Change From Baseline in Daytime Asthma Symptom Score Averaged Over the Treatment Period|Diary assessment of daytime asthma symptoms score (treatment average) by ICS dose at entry. Asthma symptoms are cough, wheeze and shortness of breath. Each symptom is usually rated from 0-3: 0-no symptoms, 1-mild, 2-moderate and 3-severe. Change from baseline (Visit 3) mean value to average value recorded at visits during treatment period; full analysis set (FAS)|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Scores on a scale||Standard Deviation|Mean
768427|NCT00703677|Secondary|Unified Parkinson Disease Rating Scale (UPDRS) Motor Subscale Score: Change From Baseline|The UPDRS is a commonly used clinical rating scale to assess motor function in patients with parkinsonism. Subjects will be assessed at baseline and Weeks 5, 12, 20, and 28.|28 weeks||||||
768269|NCT00702325|Secondary|Change From Baseline in Nighttime Asthma Symptom Score Averaged Over the Treatment Period|Diary assessment of nighttime asthma symptoms score (treatment average) by ICS dose at entry. Asthma symptoms are cough, wheeze and shortness of breath. Each symptom is usually rated from 0-3: 0-no symptoms, 1-mild, 2-moderate and 3-severe. Change from baseline (Visit 3) mean value to average value recorded at visits during treatment period; full analysis set (FAS)|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Scores on a scale||Standard Deviation|Mean
768270|NCT00702325|Secondary|Change From Baseline in Total Average Daily Asthma Symptom Score Averaged Over the Treatment Period|Diary assessment of total asthma symptoms score (treatment average) by Inhaled Corticosteroid (ICS) dose at entry. Asthma symptoms are cough, wheeze and shortness of breath. Each symptom is usually rated from 0-3: 0-no symptoms, 1-mild, 2-moderate and 3-severe. Change from baseline (Visit 3) mean value to average value recorded at visits during treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Scores on a scale||Standard Deviation|Mean
768271|NCT00702325|Secondary|Number of Withdrawals Due to a Predefined Asthma Event|Total number of participants who withdrew due to a predefined asthma event (decrease in FEV1 ≥ 20%,or to <40% of predicted normal value,12 puffs of albuterol pMDI per day on 3 or more days, decrease in morning PEF ≥ 20% on 3 or more days, use of rescue medication for 2 or more nights, emergency treatment, hospitalization, use of other asthma meds)|12 weeks|||Participants|||Number
768272|NCT00702325|Secondary|Number of First Predefined Asthma Events by Inhaled Corticosteroid (ICS) Dose at Entry|Total number of participants with any first predefined asthma event (decrease in FEV1 ≥ 20%,or to <40% of predicted normal value,12 puffs of albuterol pMDI per day on 3 or more days, decrease in morning PEF ≥ 20% on 3 or more days, use of rescue medication for 2 or more nights, emergency treatment, hospitalization, use of other asthma medication)|12 weeks|||Participants|||Number
768273|NCT00702325|Secondary|Change From Baseline in Pre-dose Forced Expiratory Flow (FEF 25-75%) Averaged Over the Treatment Period|Mean change of the FEF (25-75%) value at the baseline (Visit 3) compared to average value of the FEF (25-75%) recorded at visits during treatment period (to week 12). The mean change was calculated.|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Liters/second||Standard Deviation|Mean
768274|NCT00702325|Secondary|Change From Baseline in Pre-dose Forced Vital Capacity (FVC) Averaged Over the Treatment Period|Mean change from baseline (Visit 3) value to average value recorded at visits during treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Liters||Standard Deviation|Mean
768275|NCT00702325|Secondary|Change From Baseline in Evening Peak Expiratory Flow (PM PEF) Averaged Over the Treatment Period|Mean change from baseline (Visit 3) value to average value recorded at visits during treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Liters/minute||Standard Deviation|Mean
768276|NCT00702325|Secondary|Change From Baseline in Morning Peak Expiratory Flow (AM PEF) Averaged Over the Treatment Period|Mean change from baseline (Visit 3) value to average value recorded at visits during treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Liters/minute||Standard Deviation|Mean
768277|NCT00702325|Primary|Change From Baseline in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) Averaged Over Treatment Period|Mean change from baseline (Visit 3) value to average value recorded at visits during treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Liters||Standard Deviation|Mean
768278|NCT00702338|Primary|Number of Infants With SAEs During Follow-up|An SAE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.|From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to 12 weeks after birth on current follow-up study|Follow-up safety analysis was performed on the fetuses/infants delivered by the one expectant mother who received corifollitropin alfa + hCG on the base study P05693 (NCT00697255) and who enrolled on the follow-up study. There were no other eligible infants to be evaluated for safety.||participants|||Number
768279|NCT00702338|Primary|Number of Infants With AEs During Follow-up|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to 12 weeks after birth on current follow-up study|Follow-up safety analysis was performed on the fetuses/infants delivered by the one expectant mother who received corifollitropin alfa + hCG on the base study P05693 (NCT00697255) and who enrolled on the follow-up study. There were no other eligible infants to be evaluated for safety.||participant|||Number
768292|NCT00702403|Secondary|Patients Alive With Out Relapse|The proportion of study participants alive and without hematologic, cytogenetic or molecular evidence of BCR/ABL-positive leukemia at 1 year|Up to 1 year|Proportion alive without relapse among the total number of patients with minimal residual disease follow-up data||Participants|||Count of Participants
768293|NCT00702403|Secondary|Survival|The proportion of study participants alive at 1, 2 and 3 years|Up to 3 years|Overall Survival (complete follow-up is available out to three years for all patients)||Participants|||Count of Participants
773378|NCT00738049|Secondary|Change During Darusentan Treatment in Absolute Flow at Rest and Hyperemia||0, 2, 4, and 6 weeks|||cc/min/gm||Standard Deviation|Mean
768280|NCT00702338|Primary|Number of Mothers With Serious AEs (SAEs) During Follow-up|An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.|From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to 1 day after birth on current follow-up study (up to 1 year)|Follow-up safety analysis was performed on the one expectant mother who received corifollitropin alfa + hCG on the base study P05693 (NCT00697255) and who enrolled on the follow-up study. No mothers receiving corifollitropin alfa + recFSH in the base study were enrolled in this follow-up study or included in safety analyses.||participants|||Number
768281|NCT00702338|Primary|Number of Mothers With Adverse Events (AEs) During Follow-up|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to 1 day after birth on current follow-up study (up to 1 year)|Follow-up safety analysis was performed on the one expectant mother who received corifollitropin alfa + hCG on the base study P05693 (NCT00697255) and who enrolled on the follow-up study. No mothers receiving corifollitropin alfa + recFSH in the base study were enrolled in this follow-up study or included in safety analyses.||participants|||Number
768282|NCT00702338|Primary|Percentage of Mothers With ≥1 Live Born Infant During Follow-up (Take-Home Baby Rate): Alternate Analysis|Take-Home Baby Rate was alternately defined ad hoc as the number of participants with an ongoing pregnancy in base study P05693 (NCT00697255) with at least one live born infant in the current follow-up study divided by the total number of participants who received bolus injection of hCG in the base study.|From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to time of birth on current follow-up study (up to 1 year)|Participants in the Intent-to-Treat group (ITT) in base study P05693 (NCT00697255) that received bolus injection of hCG.||percentage of participants|||Number
768283|NCT00702338|Primary|Percentage of Mothers With ≥1 Live Born Infant During Follow-up (Take-Home Baby Rate): Protocol Defined|The Take-Home Baby Rate was defined as the number of participants with an ongoing pregnancy in base study P05693 (NCT00697255) with at least one live born infant in the current follow-up study divided by the total number of participants treated in base study P05693.|From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to time of birth on current follow-up study (up to 1 year)|Intent-to-Treat group (ITT) consisted of all treated participants in base study P05693 (NCT00697255): 5 participants in Stage Ia and 3 participants in Stage Ib.||percentage of participants|||Number
768284|NCT00702364|Secondary|Neurobehavioral Functioning Inventory Depression Subscale|"Neurobehavioral Functioning Inventory (NFI) was developed as a clinical and research tool to quantify a variety of post-injury behaviours and symptoms characteristic of neurologic disability and encountered in daily life. The inventory is comprised of 76 items organized into six analytically derived factor scales: Depression, Somatic, Memory/Attention, Communication, Aggression, and Motor. Respondents are asked to rate items as occurring never, rarely, sometimes, often, or always. Using the standardized scoring procedures outlined in the NFI Manual, T-scores were calculated for the Depression sub-scale. Lower T-score indicates less depressive symptomotology."|Post treatment|||T-score||95% Confidence Interval|Mean
768285|NCT00702364|Primary|Adult Attention Deficit Hyperactivity Disorder (ADHD) Self-Report Scale Summary Score|The Adult ADHD Self-Report Scale (ASRS-v1.1) is a self-report questionnaire that consists of questions involving the 18-items of the The Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV- Text Revision (TR) criteria for ADHD that rate symptoms on a Likert scale ranging from 0-4 based on the frequency of symptoms (“never”, “rarely”, “sometimes”, “often”, and “very often”). A previous study of the ASRS found the self-report to be both valid (Cronbach’s alpha =.88) and reliable (ICC=.84). Scores on the 18 items were summed for a total ASRS score.|Post treatment|||units on a scale||95% Confidence Interval|Mean
768286|NCT00702364|Primary|Stroop Test Interference T-score|The Stroop Color and Word Test is frequently used to study deficits of attention and executive function in individuals with TBI, and has adequate test-retest reliability. At each administration, the following scores were obtained, Word Reading, Colour Naming and Interference. Raw scores were converted to demographically-adjusted T-scores using Golden and Freshwater norm.|Post treatment|||T-score||95% Confidence Interval|Mean
768287|NCT00702364|Primary|CDR Power of Attention|"Cognitive Drug Research (CDR) Computerized Cognitive Assessment System [19] is comprised of a battery of computer-controlled tasks administered on a laptop computer with parallel forms of the tests being presented on each testing session. The Power of Attention factor of the CDR was selected as the primary outcome measure because of its strong psychometric properties in other drug studies with cognitively compromised populations.
Instead of utilizing a t-test to compare treatment and control groups, treatment and control groups for both primary and secondary outcomes were compared utilizing an analysis of covariance (ANCOVA) model in which repeat baseline measures taken on each respective outcome served as a covariate. This method controls for any differences that may exist between the groups at baseline. Model assumptions for conducting an ANCOVA were investigated for all primary and secondary analyses, where no violations of model assumptions were detected. Additionally,"|Post treatment|||msec||95% Confidence Interval|Mean
768288|NCT00702377|Primary|Corneal Staining|Corneal staining refers to the appearance of corneal abrasions when dyed with fluorescein drops during an eye examination. Fluorescein temporarily stains the surface of the cornea of the eye. An eye doctor looking at the eye’s surface through a slit lamp observes the abrasions as brightly-colored spots on an otherwise smooth cornea. Corneal staining grading scale is a 15 point scale, with 0 equals no staining (best case) and 15 equals maximum (worst) staining.|Day 0, Day 7, Day 14, Day 28, Day 42|||Units on a scale||Standard Deviation|Mean
768289|NCT00702377|Primary|Conjunctival Staining|Conjunctival staining refers to the appearance of spots on the conjunctiva when dyed with lissamine green stain during an eye examination. Lissamine green temporarily stains the surface of the conjunctiva of the eye. An eye doctor looking at the eye’s surface through a slit lamp observes the spots as green spots. Conjunctival staining grading scale is a 6 point scale, with 0 equals no staining (best case) and 6 equals maximum (worst) staining.|Day 0, Day 7, Day 14, Day 28, Day 42|||Units on a scale||Standard Deviation|Mean
768294|NCT00702403|Secondary|The Proportion of Patients at 1 Year With Treatment Efficacy Success|To be considered a treatment efficacy success at 1 year posttransplant, the patient's bone marrow must demonstrate complete hematological remission, absence of Philadelphia chromosomes, and not satisfy any of the criteria for treatment failure (>/= 1% aberrantly expressing marrow blasts by multiparameter flow cytometry, >5% BCR/ABL in marrow by fluorescent in situ hybridization, or >1 log rise in peripheral blood BCR/ABL by quantitative polymerase chain reaction (PCR) since day 80).|Up to 1 year|"The analysis population was considered in two ways: first the number of treatment success in the entire cohort (by intention to treat), and second the number of treatment successes among only those patients who did not die before 1 year from non-relapse mortality."||Participants|||Count of Participants
768295|NCT00702403|Primary|Number of Participants With Treatment Safety Failure|Safety and tolerability of nilotinib therapy in patients with imatinib-sensitive leukemia graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 4.0. Treatment safety failure is defined for a patient with imatinib sensitive Ph+ leukemia as the inability to be able to deliver at least 400 milligrams per day of nilotinib in adults, and 230 milligrams/m2 per day in children, for at least 85% of the time interval between 81 and 365 days after transplant. The overall study will be considered successful if nilotinib is deliverable to more than 75% of the study participants at this minimum specified dose intensity.|Up to 365 days post-transplant|"Critical to note are two intention-to-treat populations: the 1st (N=57) at time of consent, evolved into the second ITT population (N=40), because 17 subjects lost eligibility to begin relapse prophylaxis at engraftment. A 2nd wave of discontinuations occurred at or after Day 81 when all patients were to be switched from imatinib to nilotinib."||Participants|||Count of Participants
768296|NCT00702468|Secondary|Carer Global Impressions of Change for Ease of Transfer|"The main carer will be asked to assess the change in the subject’s condition at the end of the study (completion or withdrawal). It consists of 2 question which is rated on a seven-point scale: Very much worse, Much worse, Minimally worse, No change, Minimally better, Much better, Very much better. The carer will be asked since visit 2 (baseline):
How has the subject’s general functional abilities changed?”
How has the subject’s ease of transfer?” Not all subjects had carers; a total of 18 subjects from each treatment, of which 10 from Sativex and 14 from placebo completed it."|Day 35|||paticipants|||Number
768297|NCT00702468|Secondary|Carer Global Impressions of Change for Functional Ability|"The main carer will be asked to assess the change in the subject’s condition at the end of the study (completion or withdrawal). It consists of 2 question which is rated on a seven-point scale: Very much worse, Much worse, Minimally worse, No change, Minimally better, Much better, Very much better. The carer will be asked since visit 2 (baseline):
How has the subject’s general functional abilities changed?”
How has the subject’s ease of transfer?” Not all subjects had carers; a total of 18 subjects from each treatment, of which 10 from Sativex and 14 from placebo completed it."|Day 35|||paticipants|||Number
768298|NCT00702468|Secondary|Subject Global Impressions of Change.|"At baseline subjects will write a brief description of their spasticity caused by MS and how it affects them emotionally, physically and their ability to function with day to day activities. This will be used to aid their memory before they answer the following question which is rated on a seven-point scale.
“Please assess the change in your spasticity due to MS since immediately before receiving the first course of study treatment (Baseline) using the scale below” The markers are: Very much worse, Much worse, Minimally worse, No change, Minimally better, Much better, Very much better."|Day 35|||participants|||Number
768299|NCT00702468|Secondary|Daily Sleep Disruption NRS|Subjects will be asked: ”On a scale of 0-10 please indicate how your spasticity disrupted your sleep last night” with the anchors 0 = ‘did not disrupt sleep’, 10 = ‘completely disrupted (unable to sleep at all)’.|Week 1- Week 5|It is important to note that 16 of the placebo subjects withdrew from the study early. All subjects were accounted for in this analysis by use of a last-observation-carried-forward approach.||points on scale||Standard Deviation|Mean
768300|NCT00702468|Secondary|Timed 10-metre Walk.|The time taken to travel 10 metres.|Week 2 and Week 5|ITT. Only 4 placebo subjects were included in the analysis and 11 of the Sativex subjects. The reason for not including some of the data in this analysis is that a number of the subjects who withdrew early from the study restarted their own Sativex before the assessment was done.||Seconds||Standard Deviation|Mean
768301|NCT00702468|Secondary|Change in Motricity Index|The Motricity Index involves assessing three movements in both the arms and the legs. In the arm the three movements are; pinch grip, elbow flexion and shoulder abduction and the three leg movements are, ankle dorsiflexion, knee extension and hip flexion. The total arm/leg score is then the addition of the score for the three arm/leg movements. One point is then added to each limb score so that the maximum score is 100 points. The higher the score the better the limb movement.|Week 2 and Week 5|ITT. The reason for not including some of the data in this analysis is that a number of the subjects who withdrew early from the study restarted their own Sativex before the assessment was done.||points on scale||Standard Deviation|Mean
768302|NCT00702468|Secondary|Change in Modified Ashworth Scale.|"The Modified Ashworth Scale was completed at baseline and at the end of treatment at approximately the same time of day. All 20 muscle groups were assessed for spasticity (using a 0=no increase in muscle tone to 4 scale=affected part rigid in flexion or extensions), to result in a total score out of 80. The higher the score the worse the spasticity is.
The change from baseline to end of study was assessed. The higher the score the better"|Day 7 to Day 28|ITT. The reason for not including some of the data in this analysis is that a number of the subjects who withdrew early from the study restarted their own Sativex before the assessment was done.||score on scale||Standard Deviation|Mean
768303|NCT00702468|Secondary|Change in Mean Daily Spasticity Severity as Measured on a Spasticity Severity 0-10 Numerical Rating Scale (NRS).|"Spasticity NRS was completed daily by answering the following question:
“On a scale of ‘0 to 10’ please indicate the average level of your spasticity over the last 24 hours” with the anchors: 0 = ‘no spasticity’ and 10 = ‘worst possible spasticity’. The change in mean spasticity severity NRS from baseline to end of study (last seven days)was calculated. A negative change from baseline indicates an improvement in spasticity."|Baseline (Week 1) to Week 5|It is important to note that 17 of the placebo subjects withdrew from the study early. All subjects were accounted for in this analysis by use of a last-observation-carried-forward approach.||points on scale||Standard Deviation|Mean
768500|NCT00704028|Primary|The Number of Subjects Who Reported Treatment-emergent Adverse Events (AE's)||Day 0 through end of study (Day 42), or 28 days after the last dose of study drug whichever was longer|||participants|||Number
768304|NCT00702468|Primary|Number of Subjects Who Experience Treatment Failure.|The time to treatment failure was calculated as the number of days from the first day of treatment up to the day of treatment failure. The day of treatment failure was the earliest of:the day of premature cessation of study medication;the first day of the longest period, ending on the last day of treatment, where the mean spasticity NRS had increased by at least 20% and at least 1 unit from the treatment baseline; the day of a clinically relevant increase in anti-spasticity or disease modifying medication. The number of subjects who failed treatment were calculated.|Week 1- Week 5|||Participants|||Number
768305|NCT00702507|Secondary|Number of Participants With Mycological Cure of First to Third Recurrent Episodes|"Participants were evaluated for mycological cure, which was defined as mycological eradication with negative KOH and culture results. Participants who had mycological cure were categorized as Successes; those without mycological cure were categorized as Failures. Any discontinued or lost to follow-up participant was also considered a failure."|Test-of-cure visit (Day 14) of first to third recurrent episodes (up to approximately 1 year and 7 months)|MITT Population: only those participants with confirmed recurrence were analyzed||participants|||Number
768306|NCT00702507|Secondary|Number of Participants With Clinical Cure of First to Third Recurrent Episodes|"Participants were evaluated for clinical cure, which was defined as therapeutic cure with total resolution of signs and symptoms (i.e., no clinical signs of infection). Participants who had clinical cure were categorized as Successes; those without clinical cure were categorized as Failures. Any discontinued or lost to follow-up participant was also considered a failure."|Test-of-cure visit (Day 14) of first to third recurrent episodes (up to approximately 1 year and 7 months)|MITT Population: only those participants with confirmed recurrence were analyzed||participants|||Number
768307|NCT00702507|Secondary|Number of Participants With Overall Cure (OC) of First to Third Recurrent Episodes (RE)|"OC was defined as both clinical (therapeutic) cure with total resolution of signs/symptoms (no clinical signs of infection) and microbiological cure with mycological eradication (both negative potassium hydroxide and culture results) at TOC visit for initial episode (ep.) to third ep. Participants (par) who had OC were categorized as Successes; those without OC were categorized as Failures (discontinued/lost to follow-up par were also failures). A RE is not temporally associated with a prior episode (PE) irrespective of whether the PE involves continuing treatment with study medication."|Test-of-cure (TOC) visit (Day 14) of first to third recurrent episodes (up to approximately 1 year and 7 months)|MITT Population: only those participants with confirmed recurrence were analyzed||participants|||Number
768308|NCT00702507|Secondary|Clinical Evaluations Using Change From Baseline in the Dermatitis Severity Index Score at Day 14 of the Initial Treatment Episode|The diaper dermatitis severity index score was calculated as the sum of severity grades for each parameter evaluated (erythema, papules or pustules, and erosions). Change from baseline=baseline value minus Day 14 value. The maximum score possible for the diaper dermatitis severity index is 8. Rating scale for Erythema: 0 (none to trace), 1 (mild [pink]), 2 (moderate [red]), 3 (severe [beefy red]). Rating scale for Papules or Pustules: 0 (none to trace [0]), 1 (few [1-10]), 2 (multiple [11-20]), 3 (many [21-40]), 4 (abundant [more than 40]. Rating scale for Erosions: 0 (absent), 1 (present).|Test-of-cure visit (Day 14) of initial treatment episode|MITT Population. Participants with missing data were not included in this analysis.||scores on a scale||Full Range|Median
768309|NCT00702507|Secondary|Clinical Evaluations Using the Diaper Dermatitis Severity Index Score for Initial Treatment Episode|The diaper dermatitis severity index score was calculated as the sum of severity grades for each parameter evaluated (erythema, papules or pustules, and erosions) for the initial treatment episode. The maximum score possible for the diaper dermatitis severity index is 8. Rating scale for Erythema: 0 (none to trace), 1 (mild [pink]), 2 (moderate [red]), 3 (severe [beefy red]). Rating scale for Papules or Pustules: 0 (none to trace [0]), 1 (few [1-10]), 2 (multiple [11-20]), 3 (many [21-40]), 4 (abundant [more than 40]. Rating scale for Erosions: 0 (absent), 1 (present).|Test-of-cure visit (Day 14) of initial treatment episode|MITT Population. Participants with missing data were not included in this analysis.||scores on a scale||Full Range|Median
768310|NCT00702507|Secondary|Number of Participants With Mycological Cure|"Participants were evaluated for mycological cure, which was defined as mycological eradication with negative KOH and culture results. Participants who had mycological cure were categorized as Successes; those without mycological cure were categorized as Failures. Any discontinued or lost to follow-up participant was also considered a failure."|Test-of-cure visit (Day 14) of initial treatment episode|MITT Population||participants|||Number
768311|NCT00702507|Secondary|Number of Participants With Clinical Cure|"Participants were evaluated for clinical cure, which was defined as therapeutic cure with total resolution of signs and symptoms (i.e., no clinical signs of infection). Participants who had clinical cure were categorized as Successes; those without clianical cure were categorized as Failures. Any discontinued or lost to follow-up participant was also considered a failure."|Test-of-cure visit (Day 14) of initial treatment episode|MITT Population||participants|||Number
768312|NCT00702507|Primary|Number of Participants With Overall Cure (OC)|"OC was defined as both clinical (therapeutic) cure with total resolution of signs/symptoms (no clinical signs of infection) and microbiological cure with mycological eradication (both negative potassium hydroxide [KOH] and culture results). Participants who had OC were categorized as Successes; those without OC were categorized as Failures. Any discontinued or lost to follow-up participant was also considered a failure."|Test-of-cure visit (Day 14) of initial treatment episode|Modified Intent-to-Treat (MITT) Population: all participants who were dispensed study drug and had demonstrated clinical symptoms of diaper dermatitis (DD) (DD severity index score of 4-8; clinical erythema grade of >=2 [see outcome measure #4 for a description]) and confirmed Candida species (positive baseline KOH and culture for Candida species)||participants|||Number
768313|NCT00702520|Primary|Take-Home Baby Rate|The take-home baby rate was calculated as the number of participants with a least one live born infant in the follow-up study (P05783, 38834, NCT00702520) relative to the number of participants treated with Corifollitropin alpha in the base study (P05788, 38833, NCT00702351).|Birth of a one or more live babies (Up to 1 year)|Participants treated with Corifollitropin alpha in the base study (P05788, 38833).||Percentage of participants|||Number
768365|NCT00703053|Secondary|Number of Serious Adverse Events|Serious adverse events were collected at each study visit from the time of first vaccination through the final study visit at 180 days after the last vaccination.|Duration of study|All subjects receiving at least one study vaccination are included in the safety population and analyses of safety are intention to treat (ITT). Three subjects were randomized but not vaccinated.||Events|||Number
768314|NCT00702520|Primary|Number of Infants Experiencing SAEs|"An AE or suspected adverse reaction is considered serious if, in the view of either the investigator or sponsor, it results in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition."|Up to 1 Year|Follow-up safety analysis was performed on live born infants delivered by expectant mothers who received corifollitropin alfa in the base study P05690 (NCT00702845) and who enrolled in the follow-up study (P05783, 38834, NCT00702520).||Participants|||Number
768315|NCT00702520|Primary|Number of Infants Experiencing AEs|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the study drug.|Up to 1 Year|Follow-up safety analysis was performed on live born infants delivered by expectant mothers who received corifollitropin alfa in the base study P05690 (NCT00702845) and who enrolled in the follow-up study (P05783, 38834, NCT00702520).||Participants|||Number
768316|NCT00702520|Primary|Number of Expectant Mothers Experiencing Serious AEs (SAEs)|"An AE or suspected adverse reaction is considered serious if, in the view of either the investigator or sponsor, it results in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition."|Up to 1 Year|Follow-up safety analysis was performed on expectant mothers who received corifollitropin alfa in the base study P05690 (NCT00702845) and who enrolled in the follow-up study (P05783, 38834, NCT00702520).||Participants|||Number
768317|NCT00702520|Primary|Number of Expectant Mothers Experiencing Adverse Events (AEs)|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the study drug.|Up to 1 Year|Follow-up safety analysis was performed on expectant mothers who received corifollitropin alfa in the base study P05690 (NCT00702845) and who enrolled in the follow-up study (P05783, 38834, NCT00702520).||Participants|||Number
768318|NCT00702546|Secondary|Percentage of Participants With an Ongoing Pregnancy|An ongoing pregnancy is the presence of at least one fetus with heart activity at least 10 weeks after embryo transfer or confirmed at live birth. Ongoing pregnancies were calculated per attempt, meaning if any stage of IVF treatment was not achieved, zero values were imputed.|After one or more FTET, assessed at least 10 weeks after embryo transfer or at live birth (up to 1 year)|Participants enrolled in follow up study P05711||Percentage of participants|||Number
768319|NCT00702546|Secondary|Percentage of Participants in Follow up Study With a Vital Pregnancy|A vital pregnancy is the presence of at least one fetus with heart activity. Vital pregnancies were calculated per attempt, meaning if any stage of IVF treatment was not achieved, zero values were imputed.|After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)|Participants enrolled in follow up study P05711||Percentage of participants|||Number
768320|NCT00702546|Secondary|Percentage of Participants in Follow up Study With a Clinical Pregnancy|A clinical pregnancy is the presence of at least gestational sac or confirmed by live birth. Clinical pregnancies were calculated per attempt, meaning if any stage of in vitro fertilization (IVF) treatment was not achieved, zero values were imputed.|After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)|Participants enrolled in follow up study P05711||Percentage of participants|||Number
768321|NCT00702546|Secondary|Percentage of Participants in Follow up Study With an Ecotopic Pregnancy|An ectopic pregnancy is where the embryo implants outside the uterus. Ectopic pregnancies were calculated per total number of participants started in FTET.|After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)|Participants enrolled in follow up study P05711||Percentage of participants|||Number
768322|NCT00702546|Secondary|Percentage of Participants in Follow up Study With a Miscarriage Per Vital Pregnancy|Miscarriages were calculated per vital pregnancy, defined as the presence of at least one fetus with heart activity as assessed by USS or Doppler, or confirmed by live birth.|After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)|Participants enrolled in follow up study P05711 with vital pregnancy||Percentage of participants|||Number
768323|NCT00702546|Secondary|Percentage of Participants in Follow up Study With a Miscarriage Per Clinical Pregnancy|Miscarriages were calculated per clinical pregnancy, defined as the presence of at least one gestational sac as assessed by USS or Doppler, or confirmed by live birth.|After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)|Participants in follow up study P05711 with a clinical pregnancy||Percentage of participants|||Number
768324|NCT00702546|Primary|Percentage of Participants With an Ongoing Pregnancy (Cumulative Ongoing Pregnancy Rate)|Cumulative ongoing pregnancy rate was defined as 100 times the number of participants with an ongoing pregnancy either immediately after embryo transfer in base study P05690 (NCT00702845) or after one or more FTET cycles in follow up study P05711 following cryopreservation, divided by the total number of subjects that started treatment in base study P05690.|Up to 1 year after embryo transfer in base trial P05690 (NCT00702845), and FTET cycles in follow up study P05711|Intent-to-Treat (ITT) group from base study P05690 (NCT00702845), which consisted of randomized participants who were treated with corifollitropin alfa or recFSH.||Percentage of participants|||Number
768325|NCT00702624|Primary|Number of Infants Experiencing SAEs|An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.|Up to 12 weeks after birth|Follow-up safety analysis was performed on live born infants delivered by expectant mothers who received corifollitropin alfa or recFSH on base study P05690 (NCT00702845) and who enrolled on the follow-up study.||Live born infants|||Number
768326|NCT00702624|Primary|Number of Infants Experiencing AEs|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|Up to 12 weeks after birth|Follow-up safety analysis was performed on live born infants delivered by expectant mothers who received corifollitropin alfa or recFSH on base study P05690 (NCT00702845) and who enrolled on the follow-up study.||Live born infants|||Number
768327|NCT00702624|Primary|Number of Expectant Mothers Experiencing Serious AEs (SAEs)|An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.|From approximately 10 weeks after ET in base study P05690 up to birth of infant (up to approximately 6 months)|Follow-up safety analysis was performed on expectant mothers who received corifollitropin alfa or recFSH on base study P05690 (NCT00702845) and who enrolled on the follow-up study.||Participants|||Number
768328|NCT00702624|Primary|Number of Expectant Mothers Experiencing Adverse Events (AEs)|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|From approximately 10 weeks after ET in base study P05690 up to birth of infant (up to approximately 6 months)|Follow-up safety analysis was performed on expectant mothers who received corifollitropin alfa or recFSH on base study P05690 (NCT00702845) and who enrolled on the follow-up study.||Participants|||Number
768329|NCT00702624|Primary|Percentage of Women With ≥1 Live Born Infant During Follow-up (Take-Home Baby Rate)|The Take-Home Baby Rate was defined as the number of participants with an ongoing pregnancy in base study P05690 with at least one live born infant during follow up relative to the number of participants treated in base study.|From approximately 10 weeks after ET in base study P05690 up to birth of infant (up to approximately 6 months)|Intent-to-Treat (ITT) group from base study P05690 (NCT00702845), which consisted of randomized participants who were treated with corifollitropin alfa or recFSH.||Percentage of participants|||Number
768330|NCT00702923|Secondary|Number of Participants With PSA Recurrence.|PSA recurrence is defined as a minimum PSA value of greater or equal to 1.0ng/ml occurring within one year after the last treatment with CP-675,206, with a confirmatory PSA blood teat performed at least 2 weeks later.|one year|||participants|||Number
768331|NCT00702923|Secondary|The Number of Participants With an Increase in PSA Doubling Time||Up to 18 months after last dose of study agent|||participants|||Number
768332|NCT00702923|Primary|The Number of Participants Who Developed Cancer Antigen-specific Immune Responses||Up to 12 months after treatment with study agent|||participants|||Number
768333|NCT00702949|Secondary|Mood and Hot Flash-related Daily Interference on Activities After 6 Weeks of Treatment|Endpoints for this analysis will be median change from baseline to after week 6 of treatment. Hot Flash Related Daily Interference Scale is used to evaluate the specific impact of the study treatment on the effect hot flashes have on various life activities such as work, social, leisure and relationships. Responses to the questionnaire are recorded on a 0 to 10 scale. Lower scores are better.|Baseline, after week 6 of treatment.|||units on a scale||Full Range|Median
768334|NCT00702949|Primary|Percent Change From Baseline in Hot Flash Score at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases).|Hot flash activity will be analyzed in a number of ways. For the primary analysis, the percent change-from-baseline to hot flash score after week 6 of treatment will be compared between the highest dose treatment arm and the placebo arm. A hot flash score is computed for each patient by assigning points (1=mild, 2=moderate, 3=severe, 4=very severe) to each hot flash based on patient-reported severity, adding the points for each day, and averaging across each week of the study. Abbreviations for the analysis population description: Eligible patients (EPs). Evaluable for primary (EFP). Off-study for adverse event (AE). Do not have 6 weeks of data (NODATA).|Baseline, after week 6 of treatment|Arm II: 66 EPs, 56 are EFP and 10 are not (2 off-study by refusal, 6 AE, 1 unknown reason and 1 NODATA). Arm III: 62 EPs, 51 are EFP and 11 are not (2 off-study by refusal, 3 AE, 3 NODATA and 3 due to other reasons).||percent change||95% Confidence Interval|Median
768335|NCT00702949|Secondary|Toxicity Data for the Individual Study Arms From the Symptom Experience Diary .|A descriptive report of the toxicities experienced by participants will be measured with a Symptom Experience Diary. Participants will complete this questionnaire weekly. This patient diary contains several questions related to potential side effects and side benefits of pregabalin measured on a numeric analogue scale (based on 0-10 scale with 10 being worst toxicity, providing numbers representing the worst median changes from baseline minus Maximum (Week 1-6) Symptom Experience Diary Distributions).|Baseline, 6 weeks during treatment.|||units on a scale||Full Range|Median
768336|NCT00702949|Secondary|Comparison of 75 mg of Pregabalin vs Placebo. Percent Change From Baseline in Hot Flash Score at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases).|Hot flash activity will be analyzed in a number of ways. For the this analysis, the percent change-from-baseline to hot flash score after week 6 of treatment will be compared between the lower dose treatment arm and the placebo arm. A hot flash score is computed for each patient by assigning points (1=mild, 2=moderate, 3=severe, 4=very severe) to each hot flash based on patient-reported severity, adding the points for each day, and averaging across each week of the study. Abbreviations for the analysis population description: Eligible patients (EPs). Evaluable for primary (EFP). Off-study for adverse event (AE). Do not have 6 weeks of data (NODATA).|Baseline, after week 6 of treatment|Arm I: 63 EPs, 56 are EFP and 7 are not (3 off-study by refusal, 1 AE, 2 NODATA and 1 due to other medical reasons). Arm III: 62 EPs, 51 are EFP and 11 are not (2 off-study by refusal, 3 AE, 3 NODATA and 3 due to other reasons).||percent change||95% Confidence Interval|Median
768421|NCT00703508|Primary|Ovulation Rate Over Study Duration for STK11 Genotypes CC, CG and GG|Ovulations were determined by measurement of daily urine pregnanediol-3-glucuronide or weekly progesterone levels over 6-9 months of study duration for each participant. The ovulation rate was calculated as the number of confirmed ovulation events per months of study participation.|9 months|||ovulations/month||Standard Deviation|Mean
768337|NCT00702949|Secondary|Comparison of 75 mg of Pregabalin vs Placebo, Numerical Change From Baseline in Hot Flash Score at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases).|Hot flash activity will be analyzed in a number of ways. For the this analysis, the numerical change-from-baseline to hot flash score after week 6 of treatment will be compared between the lower dose treatment arm and the placebo arm. A hot flash score is computed for each patient by assigning points (1=mild, 2=moderate, 3=severe, 4=very severe) to each hot flash based on patient-reported severity, adding the points for each day, and averaging across each week of the study. Abbreviations for the analysis population description: Eligible patients (EPs). Evaluable for primary (EFP). Off-study for adverse event (AE). Do not have 6 weeks of data (NODATA).|Baseline, after week 6 of treatment|Arm I: 63 EPs, 56 are EFP and 7 are not (3 off-study by refusal, 1 AE, 2 NODATA and 1 due to other medical reasons). Arm III: 62 EPs, 51 are EFP and 11 are not (2 off-study by refusal, 3 AE, 3 NODATA and 3 due to other reasons).||units on a scale||95% Confidence Interval|Median
768338|NCT00702949|Secondary|Percent Change From Baseline in Hot Flash Frequency at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases).|The analysis of daily average hot flash frequency will follow as specified for the primary analysis. Abbreviations for the analysis population description: Eligible patients (EPs). Evaluable for primary (EFP). Off-study for adverse event (AE). Do not have 6 weeks of data (NODATA).|Baseline, after week 6 of treatment|||percent change||95% Confidence Interval|Median
768339|NCT00702949|Secondary|Numerical Change From Baseline in Hot Flash Frequency at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases).|The analysis of daily average hot flash frequency will follow as specified for the primary analysis. Abbreviations for the analysis population description: Eligible patients (EPs). Evaluable for primary (EFP). Off-study for adverse event (AE). Do not have 6 weeks of data (NODATA).|Baseline, after week 6 of treatment|||Hot flashes per day||95% Confidence Interval|Median
768340|NCT00702949|Primary|Numerical Change From Baseline in Hot Flash Score at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases).|Hot flash activity will be analyzed in a number of ways. For the primary analysis, the numerical change-from-baseline to hot flash score after week 6 of treatment will be compared between the highest dose treatment arm and the placebo arm. A hot flash score is computed for each patient by assigning points (1=mild, 2=moderate, 3=severe, 4=very severe) to each hot flash based on patient-reported severity, adding the points for each day, and averaging across each week of the study. Abbreviations for the analysis population description: Eligible patients (EPs). Evaluable for primary (EFP). Off-study for adverse event (AE). Do not have 6 weeks of data (NODATA).|Baseline, after week 6 of treatment|Arm II: 66 EPs, 56 are EFP and 10 are not (2 off-study by refusal, 6 AE, 1 unknown reason and 1 NODATA). Arm III: 62 EPs, 51 are EFP and 11 are not (2 off-study by refusal, 3 AE, 3 NODATA and 3 due to other reasons).||units on a scale||95% Confidence Interval|Median
768341|NCT00703014|Primary|Percentage of Mothers From the Base Trial P05787 With at Least One Live Born Infant (Take-home Baby Rate) Relative to the Number of Participants From the Base Trial With Embryo Transfer.|The take-home baby rate is 100 X the number of participants with an ongoing pregnancy in Base Trial P05787 (NCT00696800), from the ITT group, with at least one live born infant relative to the number of participants from the Base Trial with embryo transfer.|At least 10 weeks after embryo transfer in Base Trial P05787 up to birth in current Follow Up Trial (up to 1 year)|Mothers from the ITT group of the Base Trial P05787 (NCT00696800) who had ET. Infants from Follow Up Trial P05712 were not analyzed in this outcome measure.||Percentage of Participants|||Number
768342|NCT00703014|Primary|Percentage of Mothers From the Base Trial P05787 With at Least One Live Born Infant (Take-home Baby Rate) Relative to the Number of Participants in the Base Trial.|The take-home baby rate is 100 X the number of participants with an ongoing pregnancy in Base Trial P05787 (NCT00696800), from the Intent-to-Treat (ITT) group, with at least one live born infant relative to the number of participants in the Base Trial.|At least 10 weeks after embryo transfer in Base Trial P05787 up to birth in current follow up Trial (up to 1 year)|Mothers from the ITT group of the Base Trial P05787 (NCT00696800). Infants from Follow Up Trial P05712 were not analyzed in this outcome measure.||Percentage of Participants|||Number
768343|NCT00703014|Primary|Number of Infants in Current Follow Up Trial Experiencing SAEs|A SAE is any untoward medical occurrence that at any dose resulted in the following: death, was life threatening, required in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.|Up to 12 weeks following delivery (up to 1 year)|Infants born in Follow Up Trial P05712. Mothers were not analyzed in this outcome measure.||Participants|||Number
768344|NCT00703014|Primary|Number of Infants Born in Current Follow Up Trial Experiencing AEs|An AE is any untoward medical occurrence in a trial participant administered a pharmaceutical product, and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including laboratory finding), symptom, or disease temporally associated with the use of investigational medicinal product.|Up to 12 weeks following delivery (up to 1 year)|Infants born in Follow Up Trial P05712. Mothers were not analyzed in this outcome measure.||Participants|||Number
768345|NCT00703014|Primary|Number of Mothers in Current Follow Up Trial Experiencing Serious AEs (SAEs)|A SAE is any untoward medical occurrence that at any dose resulted in the following: death, was life threatening, required in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.|Up to one day following delivery (up to 1 year)|Eligible Mothers from the Base Trial P05787 (NCT00696800) who enrolled in the Follow Up Trial P05712. Infants from Follow Up Trial P05712 were not analyzed in this outcome measure.||Participants|||Number
768346|NCT00703014|Primary|Number of Mothers in Current Follow Up Trial Experiencing Adverse Events (AEs)|An AE is any untoward medical occurrence in a trial participant administered a pharmaceutical product, and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including laboratory finding), symptom, or disease temporally associated with the use of investigational medicinal product.|Up to one day following delivery (up to 1 year)|Eligible Mothers from the Base Trial P05787 (NCT00696800) who enrolled in the Follow Up Trial P05712. Infants from Follow Up Trial P05712 were not analyzed in this outcome measure.||Participants|||Number
768347|NCT00703053|Secondary|Hemagglutination Inhibition (HAI) Geometric Mean Titer (GMT) Against A/Vietnam/04 Antigen at 1, 2, 3 and 4 Weeks After 2 Doses|The kinetics of the antibody response to vaccination with A/Vietnam/04 is evaluated by the HAI GMT against the A/Vietnam/04 antigen at weekly intervals after receipt of 2 doses 7, 14 and 28 days apart|Weeks 1, 2, 3 and 4 after the second dose|Analyses are based on a modified intent to treat population. 5 subjects in the VN/VN, Day 0, 28 group not receiving vaccination 2 are excluded, as were 2, also in this group, due to receipt of prohibited vaccines.||Titer||95% Confidence Interval|Geometric Mean
768348|NCT00703053|Secondary|Neutralizing Geometric Mean Titer (GMT) Against A/Indonesia/05 Antigen at 6 Months Post Last Vaccination|The GMTs are as assessed by the microneutralization assay against the A/Indonesia/05 antigen at 6 months following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations.|Six months post last vaccination|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.||Titer||95% Confidence Interval|Geometric Mean
768349|NCT00703053|Secondary|Neutralizing Geometric Mean Titer (GMT) Against A/Vietnam/04 Antigen at 6 Months Post Last Vaccination|The GMTs are as assessed by the microneutralization assay against the A/Vietnam/04 antigen at 6 months following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations.|Six months post last vaccination|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.||Titer||95% Confidence Interval|Geometric Mean
768350|NCT00703053|Secondary|Hemagglutination Inhibition (HAI) Geometric Mean Titer (GMT) Against A/Indonesia/05 Antigen at 6 Months Post Last Vaccination|The GMTs are as assessed by the HAI assay against the A/Indonesia/05 antigen at 6 months following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations. The CI shown as 5.0 to 5.0 reflect that all subjects had a titer of 5.0 for the VN,VN, Day 0,14 and VN, Day 0 groups.|Six months after last vaccination|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.||Titer||95% Confidence Interval|Geometric Mean
768351|NCT00703053|Secondary|Hemagglutination Inhibition (HAI) Geometric Mean Titer (GMT) Against A/Vietnam/04 Antigen at 6 Months Post Last Vaccination|The GMTs are as assessed by the HAI assay against the A/Vietnam/04 antigen at 6 months following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations.|Six months post last vaccination|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.||Titer||95% Confidence Interval|Geometric Mean
768352|NCT00703053|Secondary|Number of Subjects Achieving Neutralizing Antibody Titer of 1:40 or Greater Against A/Indonesia/05 Antigen|The number of subjects who achieve a titer of 1:40 or greater as assessed by the microneutralization assay against the A/Indonesia/05 antigen at 28 days following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations.|28 days post last vaccination.|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.||Participants|||Number
768353|NCT00703053|Secondary|Number of Subjects Achieving Neutralizing Antibody Titer of 1:40 or Greater Against A/Vietnam/04 Antigen|The number of subjects who achieve a titer of 1:40 or greater as assessed by the microneutralization assay against the A/Vietnam/04 antigen at 28 days following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations.|28 days post last vaccination.|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.||Participants|||Number
768354|NCT00703053|Secondary|Number of Subjects Achieving a 4-fold or Greater Neutralizing Antibody Titer Increase Against A/Indonesia/05 Antigen|The number of subjects who achieve a 4-fold or greater rise in titer, relative to the baseline (Day 0) titer, assessed by the microneutralization assay against the A/Indonesia/05 antigen at 28 days following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations. Subjects whose baseline titer is <10 must have a post vaccination titer of at least 1:40 to be considered a 4-fold rise.|28 days post last vaccination.|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.||Participants|||Number
768355|NCT00703053|Primary|Number of Subjects Achieving a HAI Antibody Titer of 1:40 or Greater Against A/Indonesia/05 Antigen|The number of subjects who achieve a HAI antibody titer of 1:40 or greater as assessed by the HAI assay against the A/Indonesia/05 antigen at 28 days following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations.|28 days post last vaccination.|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.||Participants|||Number
768422|NCT00703508|Primary|Number of Responders/Non-responders for Each STK11 rs8111699 Genotype (C/G, C/C, G/G)|Responders were defined as those that had a doubling of baseline ovulation rate estimated by self-report of menstrual history.|9 months|||participants|||Number
768709|NCT00699400|Secondary|Oocyte Level Live Birth Rate|Oocyte Level Live Birth Rate was calculated from the total number of live births divided by the total number of oocytes thawed less the total number of embryos cryopreserved from thawed oocytes|Birth of one or more live babies|||% of all oocytes thawed|Participants||Number
768356|NCT00703053|Primary|Number of Subjects Achieving a HAI Antibody Titer of 1:40 or Greater Against A/Vietnam/04 Antigen|The number of subjects who achieve a HAI antibody titer of 1:40 or greater as assessed by the HAI assay against the A/Vietnam/04 antigen at 28 days following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations.|28 days post last vaccination.|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.||Participants|||Number
768357|NCT00703053|Primary|Number of Subjects Achieving a 4-fold or Greater HAI Antibody Titer Increase Against A/Indonesia/05 Antigen|The number of subjects who achieve a 4-fold or greater rise in titer, relative to the baseline (Day 0) titer, assessed by the HAI assay against the A/Indonesia/05 antigen at 28 days following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations. Subjects whose baseline titer is <10 must have a post vaccination titer of at least 1:40 to be considered a 4-fold rise.|28 days post last vaccination.|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.||Participants|||Number
768358|NCT00703053|Primary|Number of Subjects Achieving a 4-fold or Greater HAI Antibody Titer Increase Against A/Vietnam/04 Antigen|The number of subjects who achieve a 4-fold or greater rise in titer, relative to the baseline (Day 0) titer, assessed by the HAI assay against the A/Vietnam/04 antigen at 28 days following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations. Subjects whose baseline titer is <10 must have a post vaccination titer of at least 1:40 to be considered a 4-fold rise.|28 days post last vaccination.|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.||Participants|||Number
768359|NCT00703053|Primary|Hemagglutination Inhibition (HAI) Geometric Mean Titer (GMT) Against A/Indonesia/05 Antigen|The GMTs are as assessed by the HAI assay against the A/Indonesia/05 antigen at 28 days following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations.|28 days post last vaccination.|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.||Titer||95% Confidence Interval|Geometric Mean
768360|NCT00703053|Secondary|Number of Subjects Achieving a 4-fold or Greater Neutralizing Antibody Titer Increase Against A/Vietnam/04 Antigen|The number of subjects who achieve a 4-fold or greater rise in titer, relative to the baseline (Day 0) titer, assessed by the microneutralization assay against the A/Vietnam/04 antigen at 28 days following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations. Subjects whose baseline titer is <10 must have a post vaccination titer of at least 1:40 to be considered a 4-fold rise.|28 days post last vaccination.|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.||Participants|||Number
768361|NCT00703053|Secondary|Neutralizing Geometric Mean Titer (GMT) Against A/Indonesia/05 Antigen|The GMTs are as assessed by the microneutralization assay against the A/Indonesia/05 antigen at 1 month following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations.|28 days post last vaccination.|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.||Titer||95% Confidence Interval|Geometric Mean
768362|NCT00703053|Secondary|Neutralizing Geometric Mean Titer (GMT) Against A/Vietnam/04 Antigen|The GMTs are as assessed by the microneutralization assay against the A/Vietnam/04 antigen at 1 month following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations.|28 days post last vaccination.|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.||Titer||95% Confidence Interval|Geometric Mean
768363|NCT00703053|Secondary|Number of Subjects Reporting Solicited Symptoms Within 7 Days of Second Vaccination|Subjects record the occurrence of solicited symptoms on a Memory Aid for 7 days after the second vaccination and review the Memory Aid with clinic staff at a follow up visit on Day 8. Subjects are counted if they indicated experiencing the symptom at any severity during the reporting period. The symptoms of redness and swelling were solicited as both functional grading as impact on daily activies as well as collected as a measured value in mm. The number reported for all symptoms is the number reporting greater than none.|7 days after second vaccination|All subjects receiving the second vaccination are included in this outcome measure. The VN, Day 0 Group received only one dose.||Participants|||Number
768364|NCT00703053|Secondary|Number of Subjects Reporting Solicited Symptoms Within 7 Days of First Vaccination|Subjects record the occurrence of solicited symptoms on a Memory Aid for 7 days after first vaccination and review the Memory Aid with clinic staff at follow a up visit on Day 8. Subjects are counted if they indicated experiencing the symptom at any severity during the reporting period. The symptoms of redness and swelling were solicited as both functional grading as impact on daily activies as well as collected as a measured value in mm. The number reported for all symptoms is the number reporting greater than none.|7 days after first vaccination|All subjects receiving the first vaccination are included in the safety population and analyses of safety are ITT. Three subjects were randomized but not vaccinated.||Participants|||Number
768899|NCT00708110|Secondary|Median Change From Baseline in Plasma HIV-1 RNA Levels During the Follow-up Period (Days 11 to 21)|Change from Baseline in Plasma HIV-1 RNA levels was calculated as the value during the Follow-up period minus the Basline value.|Baseline and Follow-up period (Days 11 to 21)|ITT(E) Population||Log10 copies/mL||Full Range|Median
768366|NCT00703053|Primary|Hemagglutination Inhibition (HAI) Geometric Mean Titer (GMT) Against A/Vietnam/04 Antigen|The GMTs are as assessed by the HAI assay against the A/Vietnam/04 antigen at 28 days following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations.|28 days post last vaccination.|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.||Titer||95% Confidence Interval|Geometric Mean
768369|NCT00703118|Secondary|Number of Participants Acheiving Extended Rapid Virologic Response at Week 4 and Week 12|Extended rapid virologic response was defined as undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) levels.|Week 4 and Week 12|All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study medication.||Participants|||Number
768370|NCT00703118|Secondary|Change From Baseline in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4||Baseline (Day 1) to Week 4|All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study medication.||log10 IU/mL||Standard Deviation|Mean
768371|NCT00703118|Secondary|Number of Participants Who Have Viral Relapse During Entire Follow-up Period (up to Week 72)|Viral relapse was defined as having confirmed detectable Hepatitis C virus (HCV) ribonucleic acid (RNA) levels during entire follow-up period (up to Week 72).|Up to Week 72|All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study medication.||Participants|||Number
768372|NCT00703118|Secondary|Number of Participants Who Meet the Telaprevir Stopping Rule at Week 4, Week 6, or Week 8|Telaprevir stopping rule is defined as having Hepatitis C virus (HCV) ribonucleic acid (RNA) levels >100 IU/mL at Week 4, Week 6, or Week 8 after start of telaprevir.|Week 4, Week 6, or Week 8|All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study medication.||Participants|||Number
768373|NCT00703118|Secondary|Number of Participants With Sustained Virologic Response (SVR) 12 Weeks After the Last Planned Dose of Study Medication - SVR12 Planned|SVR12 planned was defined as having undetectable plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) levels 12 weeks after the last planned dose of study medication (SVR12 planned).|Week 60|All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study medication.||Participants|||Number
768374|NCT00703118|Secondary|Number of Participants Acheiving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Week 48 (End of Treatment)||Week 48|All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study medication.||Participants|||Number
768375|NCT00703118|Secondary|Number of Participants Acheiving Rapid Virologic Response (RVR) at Week 4|RVR was defined as having undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 4.|Week 4|All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study medication.||Participants|||Number
768376|NCT00703118|Primary|Number of Participants With Sustained Virologic Response (SVR) 24 Weeks After the Last Planned Dose of Study Medication - SVR24 Planned|SVR24 planned is defined as having undetectable plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) levels 24 weeks after the last planned dose of study medication.|Week 72|Full Analysis Set: All randomized participants who received at least one dose of study medication.||Participants|||Number
768377|NCT00703157|Secondary|Left Atrial Dimension and Contractility||Through 24 months post-ablation|Data were not collected|||||
768378|NCT00703157|Secondary|Reduced Anti-arrhythmic Drug Requirement||Through 24 months post-ablation|Data were not collected|||||
768379|NCT00703157|Secondary|Assessment of AF Burden||Through 24 months post-ablation|Data were not collected|||||
768380|NCT00703157|Secondary|Occurences of Treatment of Arrhythmic Episodes||Through 24 months post-ablation|Data were not collected|||||
768381|NCT00703157|Secondary|Symptoms Associated With Atrial Arrhythmias||Through 24 months post-ablation|Data were not collected|||||
768382|NCT00703157|Secondary|Reduced Number, Duration and Severity of AF Symptoms||Through 24 months post-ablation|Data were not collected|||||
768383|NCT00703157|Secondary|Duration, Burden and Costs of Treatment Procedures||Through 24 months post- ablation|Data were not collected|||||
768384|NCT00703157|Secondary|Mortality and Hospitalization||Time from procedure until 24 months post-ablation|||participants|||Number
768385|NCT00703157|Secondary|Number of Subjects With Adverse Events, Associated With the Ablation Procedure||Time from procedure|||Participants|||Count of Participants
768386|NCT00703157|Secondary|Treatment Failures Requiring Redo or Alternative Therapy||Time from procedure until 6 months post-ablation|||Participants|||Count of Participants
768387|NCT00703157|Primary|Change in AF Burden After Ablation Therapy Measured With REVEAL-XT Implantable Device.|AF Burden is defined as the percentage of time during the follow-up period that a subject is in AF, as measured by the REVEAL-XT implantable device.|Baseline through 3-6 months post-ablation|||percentage of time in AF||Standard Deviation|Mean
768388|NCT00703261|Secondary|Percent Reduction From Baseline in TBRmeanmax of the Qualifying Segment in Statin-naive Participants|Vascular plaque inflammation was measured by 18FDG-PET imaging. Uptake of FDG by the carotid and thoracic aorta is expressed as the target, vessel wall to background, lumen ratio (TBR). TBRmax of an axial cross section of a vessel (a slice) is defined as the maximum TBR within a slice and TBRmeanmax is the mean of TBRmax for all slices in the qualifying segment. The qualifying segment is the left or right carotid or thoracic aorta with the greatest FDG uptake value at Baseline.|Baseline and Week 12|The analysis population includes all statin-naive participants who completed the study and had complete image sets.||Percent reduction||90% Confidence Interval|Geometric Mean
768389|NCT00703261|Primary|Percent Reduction From Baseline in TBRmeanmax of the Qualifying Segment|Vascular plaque inflammation was measured by 18FDG-PET imaging. Uptake of FDG by the carotid and thoracic aorta is expressed as the target, vessel wall to background, lumen ratio (TBR). TBRmax of an axial cross section of a vessel (a slice) is defined as the maximum TBR within a slice and TBRmeanmax is the mean of TBRmax for all slices in the qualifying segment. The qualifying segment is the left or right carotid or thoracic aorta with the greatest FDG uptake value at Baseline.|Baseline and Week 12|The analysis population includes all participants who completed the study and had complete image sets with usable data.||Percent reduction||90% Confidence Interval|Geometric Mean
768390|NCT00703326|Secondary|Number of Participants With Adverse Events|Clinically significant events were defined as serious adverse events (SAE) and other treatment-emergent non-serious adverse events (NSAE). A summary of SAEs and other NSAEs is located in the Reported Adverse Event module.|First dose to study completion (up to 49 months) plus 30-day safety follow-up|All randomized participants who received at least 1 dose of study drug.||participants|||Number
768391|NCT00703326|Other Pre-specified|Serum Anti-Ramucirumab Antibody Assessment (Immunogenicity)|The overall percentage of participants with treatment-emergent positive for anti-ramucirumab (IMC-1121B) antibodies during the study. Participants were considered positive for anti-ramucirumab (IMC-1121B) antibodies if they exhibited a post-treatment antibody level that exceeded the positive upper cut point determined from the anti-ramucirumab (IMC-1121B) level seen in healthy untreated individuals.|Baseline, prior to cycle 3 infusion, prior to cycle 5 infusion, onset of infusion reaction, resolution of reaction and 30 days following the event until data cutoff of 31-Mar-2013 (up to 31 months)|All randomized participants who received at least 1 dose of study drug with anti-IMC-1121B antibodies samples collected during the study.||percentage of participants|||Number
768392|NCT00703326|Secondary|Total Functional Assessment of Cancer Therapy-Breast (FACT-B): Change From Baseline to End of Therapy|FACT-B measures the following domains of health-related quality of life (HR-QL): physical well-being (PWB), social/family well-being (SFWB), emotional well-being (EWB), functional well-being (FWB), and additional concerns of breast cancer subscale (BCS) each with 6 or more items developed to measure problems specific to breast cancer symptoms plus additional items related to global QoL. Participants respond to each of the 36 questions on a 5-point scale from 0 (not at all) to 4 (very much) with a total scores range of 0-144. Higher scores indicate fewer symptoms and better HR-QoL.|Baseline, End of Therapy or until data cutoff of 31-Mar-2013 (up to 42 months)|A subset of Intent-to-Treat (ITT) Population: all randomized participants with a valid baseline and end of therapy assessments.||units on a scale||Standard Deviation|Mean
768393|NCT00703326|Secondary|Duration of Response|Duration of complete response (CR) or partial response (PR) measured from time criteria were first met for CR or PR until first date of progressive disease (PD) or death from any cause defined using Response Evaluation Criteria in Solid Tumor (RECIST 1.0); by Investigator assessment. CR defined as disappearance of all target and non-target lesions. PR defined as ≥30% decrease in sum of longest diameter (LD) of target lesions and no progression in non-target lesions. PD defined as ≥20% increase in LD sum of target lesions taking as reference the smallest sum LD since baseline, progression in non-target lesions or the appearance of ≥1 new lesion(s). Participants who did not relapse or die censored at day of last radiographic tumor assessment. If death or PD was after ≥2 missing radiographic visits, censoring was at date of last radiographic visit prior to missed visits. Symptomatic/clinical disease progression without documented radiologic progression did not constitute progression.|Date of first CR or PR to PD or death or until data cutoff date of 31-Mar-2013 (up to 35 months)|A subset of the Intent-to-Treat (ITT) Population: all randomized participants with CR or PR. Censored participants: ramucirumab + docetaxel=80, placebo + docetaxel=28.||months||95% Confidence Interval|Median
768394|NCT00703326|Secondary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate)|Objective response rate (ORR) was defined as the percentage of randomized participants achieving a best confirmed overall response of CR or PR using Response Evaluation Criteria in Solid Tumors (RECIST v1.0), based on the achievement of both measurement and confirmation criteria; by Investigator assessment. CR was defined as the disappearance of all target and non-target lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions, taking as reference the baseline sum LD and no progression in non-target lesions.|Randomization to disease progression or until data cutoff of 31-Mar-2013 (up to 48 months)|Intent-to-Treat (ITT) Population: All randomized participants.||percentage of participants||95% Confidence Interval|Number
768395|NCT00703326|Secondary|Time to Progression (TTP)|TTP was defined as the time from the date of randomization to the first documented date of disease progression using Response Evaluation Criteria in Solid Tumors (RECIST v1.0) criteria; by Investigator assessment. Progressive disease (PD) was defined as at least a 20% increase in sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD since baseline, progression in non-target lesions or the appearance of 1 or more new lesion(s). Participants who did not progress were censored at the last radiographic tumor assessment. If no post-baseline assessment was available censoring occurred at the date of randomization. If PD occurred after 2 or more missing radiographic visits, censoring occurred at the date of the last radiographic visit prior to the missed visits. The symptomatic/clinical disease progression (deterioration) without documented radiologic progression did not constitute progression.|Randomization to disease progression or until data cutoff of 31-Mar-2013 (up to 48 months)|Intent-to-Treat (ITT) Population: All randomized participants. Censored participants: ramucirumab + docetaxel=263, placebo + docetaxel=104.||months||95% Confidence Interval|Median
768396|NCT00703326|Secondary|Overall Survival (OS)|OS was defined as the duration from randomization to death from any cause. Participants who were alive at data cut-off for the OS analysis or lost to follow-up were censored on the last date the participant was known to be alive.|Randomization to death or until data cutoff of 31-Mar-2013 (up to 49 months)|Intent-to-Treat (ITT) Population: All randomized participants. Censored participants: ramucirumab + docetaxel=448, placebo + docetaxel=225.||months||95% Confidence Interval|Median
768423|NCT00703534|Primary|Symptom Intensity Rated by Participants Twice Daily Using an Electronic Reflux Symptom Questionnaire Diary|Symptom intensity rated on a six-graded Likert scale (Did not have; Very mild; Mild; Moderate; Moderately severe; Severe)|Run-in period of 8-12 days and treatment period of 26-30 days|None of the analyses addressing the objectives related to validation of the patient reported outcome measures were made per treatment arm and can therefore not be reported in this format.||participants|||Number
768397|NCT00703326|Primary|Progression-Free Survival (PFS)|PFS was defined as time from randomization until the first evidence of progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.0) or death from any cause; by Investigator assessment. Progressive disease (PD) was defined as at least a 20% increase in sum of longest diameter of target lesions taking as reference the smallest sum longest diameter since baseline, progression in non-target lesions or the appearance of 1 or more new lesion(s). Participants who neither progressed nor died were censored the day of their last radiographic tumor assessment if available or date of randomization if no post initiation radiographic assessment was available. If death or PD occurred after ≥2 missing radiographic visits, censoring occurred at date of the last radiographic visit prior to the missed visits. The symptomatic/clinical disease progression (deterioration) without documented radiologic progression did not constitute progression.|Randomization to disease progression or death or until data cutoff of 31 Mar 2013 (up to 48 months)|Intent-to-Treat (ITT) Population: All randomized participants. Censored participants: ramucirumab + docetaxel=231, placebo + docetaxel=94.||months||95% Confidence Interval|Median
768398|NCT00703339|Secondary|Pharmacokinetic (PK) Parameters After a Single Dose of Inhaled Treprostinil and Acute Hemodynamic Effects.|PK samples will be collected at frequent intervals up to 4 hours following single dosing . Hemodynamic parameters at 4 hours post dosing include heart rate, pulmonary arterial pressure, systemic arterial pressure, right atrial pressure, pulmonary capillary wedge pressure, mixed venous oxygen saturation and cardiac output.|acute||||||
768399|NCT00703339|Primary|Safety and Tolerability of Inhaled Treprostinil Sodium in Patients With Pulmonary Hypertension Associated With Idiopathic Pulmonary Fibrosis,Reported as Number of Participants With Adverse Events|Safety and Tolerability evaluation include any observed or reported changes in vital signs, ECGs, clinical chemistry ,hematological or urinalysis, and any reported symptoms following a single dose administration on the day of dosing and up to the final visit 3-5 days later. Adverse events will be tabulated by total incidence and by individual patient, and the severity, causality and outcomes will also be documented. Each cohort of 4 patients will be fully evaluated as described before proceeding to the escalation to the next dose.|3-5 days|Insufficient enrollment, therefore no Participants were analyzed.||participants|||Number
768400|NCT00703391|Primary|Renal Clearance of Drug From Plasma (CLR)|CLR following 14 days' dosing|Pre-dose on day -1 to day 15 (end of dosing)|||L/h||Full Range|Geometric Mean
768401|NCT00703391|Primary|Terminal Half-life of Drug in Plasma (t1/2)|t1/2 following 14 days' dosing|Pre-dose on day -1 to day 15 (end of dosing)|||hours||Full Range|Median
768402|NCT00703391|Primary|Time to Reach Observed Peak or Maximum Concentration Following Oral Drug Administration (Tmax)|tmax following 14 days' dosing|Pre-dose on day -1 to day 15 (end of dosing)|||hours||Full Range|Median
768403|NCT00703391|Primary|Observed Peak or Maximum Plasma Concentration Following Drug Administration (Cmax)|Cmax following 14 days' dosing|Pre-dose on day -1 to day 15 (end of dosing)|||nM||Full Range|Geometric Mean
768404|NCT00703391|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours Post-dose (AUC(0-12))|AUC(0-12) following 14 days' dosing|Pre-dose on day -1 to day 15 (end of dosing)|||nM.h||Full Range|Geometric Mean
768405|NCT00703391|Primary|FEV1 (Forced Expiratory Volume in the First Second)|Change from baseline to Day 14|Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)|||L||Standard Deviation|Mean
768406|NCT00703391|Secondary|Quantitative Sputum Bacteriology|Number of patients with an increase in bacteriological count from Day -1 to Day 15|Pre-dose day -1 to post-dose on day 15|||Participants|||Number
768407|NCT00703391|Secondary|AZD9668 Sputum Concentrations||Pre-dose day -1 to post-dose on day 14|||nM||Full Range|Geometric Mean
768408|NCT00703391|Secondary|Sputum Differential Neutrophil Count|Change from baseline to Day 14 in percentage neutrophil count|Pre-dose day -1 to post-dose on day 14|||Percentage||Full Range|Median
768409|NCT00703391|Secondary|Sputum Absolute Neutrophil Count|Change from baseline to Day 14 in absolute neutrophil count|Pre-dose day -1 to post-dose on day 14|||10**9/L||Full Range|Median
768410|NCT00703391|Primary|QTcF|QTcF change from baseline greater than 60 ms|Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)|||Participants|||Number
768411|NCT00703391|Primary|QTcF (QT Interval Corrected for Heart Rate by Fridericia’s Method)|QTcF interval greater than 450 ms|Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)|||Participants|||Number
768412|NCT00703391|Primary|Leucocytes|Change from baseline to Day 14|Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)|||10**9/L||Standard Deviation|Mean
768413|NCT00703391|Primary|Reticulocytes|Change from baseline to Day 14|Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)|||relative particle count (%)||Standard Deviation|Mean
768414|NCT00703391|Primary|Haemoglobin (Hb)|Change from baseline to Day 14|Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)|||g/L||Standard Deviation|Mean
768415|NCT00703391|Primary|Creatinine|Creatinine level greater than the upper limit of normal|Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)|||Participants|||Number
768416|NCT00703391|Primary|Total Bilirubin|Change from baseline to Day 14|Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)|||micromol/L||Standard Deviation|Mean
768417|NCT00703391|Primary|Creatine Kinase (CK)|Change from baseline to Day 14|Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)|||IU/L||Standard Deviation|Mean
768418|NCT00703391|Primary|Aspartate Aminotransferase (AST)|AST level greater than 3 times the upper limit of normal|Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)|||Participants|||Number
768419|NCT00703391|Primary|Alanine Aminotransferase (ALT)|ALT level greater than 3 times the upper limit of normal|Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)|||Participants|||Number
768420|NCT00703508|Secondary|Determine in Which Genotype(s) Frequency of Ovulation Correlates With Improvement in Reduction in Total Testosterone and Insulin Sensitivity as Measured by the Matsuda Index.|Bivariate fit (RSquare with P values) of ovulation rate post treatment by change in total testosterone and Matsuda Index for each of the 3 genotypes (G/G, C/G, C/C)|9 months|Individuals that were lost to follow up had missing data on testosterone and OGTT (oral glucose tolerance testing) for Matsuda index.||Correlation coefficient (r^2)|||Number
768428|NCT00703677|Secondary|PSP Rating Scale Score: Change From Baseline|The PSP Rating Scale is a 28-item scale designed to assess the disability associated with PSP. The six functional categories assessed are: daily activities, behavior, bulbar function, oculomotor function, limb motor function, and gait/midline function. Subjects will be assessed at baseline and Weeks 12, 20, and 28.|28 weeks||||||
768429|NCT00703677|Secondary|Change in Glycogen Synthase Kinase (GSK)-3 Beta Activity|Levels of beta-catenin and the ratio of phosphorylated GSK-3 beta to total GSK-3 beta will be measured at baseline and at Week 28|28 weeks|Due to the very small number of samples collected, samples were not analyzed.|||||
768430|NCT00703677|Secondary|Change in Brain-Derived Neurotrophic Factor (BDNF) in CSF|With inhibition of Glycogen Synthase Kinase (GSK)-3 beta, levels of BDNF may increase. BDNF levels will be measured at baseline and at Week 28.|28 weeks|Due to the very small number of samples collected, samples were not analyzed|||||
768431|NCT00703677|Secondary|Changes in Amount of Tau and Phosphorylated Tau in Cerebral Spinal Fluid (CSF)|Progressive supranuclear palsy (PSP) and corticobasal degeneration (CBD) are characterized by hyperphosphorylation of tau. Lithium inhibits one of the kinases (GSK-3 beta) that phosphorylates tau; levels of tau phosphorylation will be measured at baseline and at Week 28.|28 weeks|Due to the very small number of samples collected, samples were not analyzed|||||
768432|NCT00703677|Secondary|Study Drug Compliance|Subjects receiving 80% or more of the prescribed doses between study visits were considered compliant.|28 weeks|All subjects were evaluated for compliance.||Subjects|||Number
768433|NCT00703677|Primary|Ability to Tolerate Lithium Carbonate|The ability to complete the study period on lithium at a serum concentration of at least 0.4 mEq/L.|28 weeks|One subject completed the full 28 week course of study drug; 13 subjects stopped drug early due to intolerability.||Subject|||Number
768434|NCT00703729|Secondary|Use of Pain Medication on Day 7|Pain medication was quantified using a morphine equivalent dosage (MED) with the following scale: 1 mg of oral morphine = 1 morphine equivalent. 3 mg morphine = 3 mg hydrocodone = 2 mg oxycodone|1 day|||Morphine Equivalent Dosage||Standard Deviation|Mean
768435|NCT00703729|Secondary|Use of Pain Medication on Day 6|Pain medication was quantified using a morphine equivalent dosage (MED) with the following scale: 1 mg of oral morphine = 1 morphine equivalent. 3 mg morphine = 3 mg hydrocodone = 2 mg oxycodone|1 day|||Morphine Equivalent Dosage||Standard Deviation|Mean
768436|NCT00703729|Secondary|Use of Pain Medication on Day 5|Pain medication was quantified using a morphine equivalent dosage (MED) with the following scale: 1 mg of oral morphine = 1 morphine equivalent. 3 mg morphine = 3 mg hydrocodone = 2 mg oxycodone|1 day|||Morphine Equivalent Dosage||Standard Deviation|Mean
768437|NCT00703729|Secondary|Use of Pain Medication on Day 4|Pain medication was quantified using a morphine equivalent dosage (MED) with the following scale: 1 mg of oral morphine = 1 morphine equivalent. 3 mg morphine = 3 mg hydrocodone = 2 mg oxycodone|1 day|||Morphine Equivalent Dosage||Standard Deviation|Mean
768438|NCT00703729|Secondary|Use of Pain Medication on Day 3|Pain medication was quantified using a morphine equivalent dosage (MED) with the following scale: 1 mg of oral morphine = 1 morphine equivalent. 3 mg morphine = 3 mg hydrocodone = 2 mg oxycodone|1 day|||Morphine Equivalent Dosage||Standard Deviation|Mean
768439|NCT00703729|Secondary|Use of Pain Medication on Day 2|Pain medication was quantified using a morphine equivalent dosage (MED) with the following scale: 1 mg of oral morphine = 1 morphine equivalent. 3 mg morphine = 3 mg hydrocodone = 2 mg oxycodone|1 day|||Morphine Equivalent Dosage||Standard Deviation|Mean
768440|NCT00703729|Primary|Patient Reported Pain on Day 7|"Pain was measured using a visual analog scale (VAS) 10 cm in length, with no pain at the left side of the scale and extreme pain at the right side. Scores were measured to the closest millimeter for a 0-100 scale."|1 day|||Visual Analog Score (0-100)||Standard Deviation|Mean
768441|NCT00703729|Primary|Patient Reported Pain on Day 6|"Pain was measured using a visual analog scale (VAS) 10 cm in length, with no pain at the left side of the scale and extreme pain at the right side. Scores were measured to the closest millimeter for a 0-100 scale."|1 day|||Visual Analog Score (0-100)||Standard Deviation|Mean
768442|NCT00703729|Primary|Patient Reported Pain on Day 5|"Pain was measured using a visual analog scale (VAS) 10 cm in length, with no pain at the left side of the scale and extreme pain at the right side. Scores were measured to the closest millimeter for a 0-100 scale."|1 day|||Visual Analog Score (0-100)||Standard Deviation|Mean
768443|NCT00703729|Primary|Patient Reported Pain on Day 4|"Pain was measured using a visual analog scale (VAS) 10 cm in length, with no pain at the left side of the scale and extreme pain at the right side. Scores were measured to the closest millimeter for a 0-100 scale."|1 day|||Visual Analog Score (0-100)||Standard Deviation|Mean
768444|NCT00703729|Primary|Patient Reported Pain on Day 3|"Pain was measured using a visual analog scale (VAS) 10 cm in length, with no pain at the left side of the scale and extreme pain at the right side. Scores were measured to the closest millimeter for a 0-100 scale."|1 day|||Visual Analog Score (0-100)||Standard Deviation|Mean
768445|NCT00703729|Primary|Patient Reported Pain on Day 2|"Pain was measured using a visual analog scale (VAS) 10 cm in length, with no pain at the left side of the scale and extreme pain at the right side. Scores were measured to the closest millimeter for a 0-100 scale."|1 day|||Visual Analog Score (0-100)||Standard Deviation|Mean
768446|NCT00703729|Primary|Patient Reported Pain on Day 1|"Pain was measured using a visual analog scale (VAS) 10 cm in length, with no pain at the left side of the scale and extreme pain at the right side. Scores were measured to the closest millimeter for a 0-100 scale."|1 day|||Visual Analog Score (0-100)||Standard Deviation|Mean
768447|NCT00703729|Secondary|Use of Pain Medication on Day 1|Pain medication was quantified using a morphine equivalent dosage (MED) with the following scale: 1 mg of oral morphine = 1 morphine equivalent. 3 mg morphine = 3 mg hydrocodone = 2 mg oxycodone|1 day|||Morphine Equivalent Dosage||Standard Deviation|Mean
768448|NCT00703729|Primary|Patient Reported Pain on Day 0|"Pain was measured using a visual analog scale (VAS) 10 cm in length, with no pain at the left side of the scale and extreme pain at the right side. Scores were measured to the closest millimeter for a 0-100 scale."|1 day|||Visual Analog Score (0-100)||Standard Deviation|Mean
768449|NCT00703781|Secondary|Number of Participants That Are Pain Free|Participant description of being pain free taken from patient questionnaire with multiple possible responses (None, Mild, Moderate, Severe) within one hour of instilling eye drop|Day 1|LOCF Analysis, ITT Population||Participants|||Number
768450|NCT00703781|Primary|Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero|Participants with SOIS of 0. Scale: 0=0 cells (complete absence); 0.5=1-5 cells (trace); 1=6-15 cells (very slight); 2=16-25 cells (moderate); 3=26-50 cells (marked); 4=>50 cells (intense)|Day 15|Last Observation Carried Forward Analysis (LOCF). Intent to treat population (ITT)||Participants|||Number
768451|NCT00703846|Secondary|Mean Change From Baseline for the Functional Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 52 (or Early Termination)|Skindex-29 is a 3-component (symptomatic, emotional, and functional) self-administered questionnaire (comprised of 30 questions) used to comprehensively measure the complex effects of skin diseases on a participant's quality of life. For the functional component, participants were asked to answer 15 questions based on a 5-point scale concerning their feelings over the past 4 weeks about the skin condition that has bothered them the most: 1, never; 2, rarely; 3, sometimes; 4, often; 5, all the time. The Functional Score is the sum of the 12 question scores; total score ranges from 15 to 75.|Baseline and Week 52 (or Early Termination)|Safety Analysis Set. Participants who submitted incomplete questionnaires (missing values) were excluded from the analysis.||units on a scale||Standard Deviation|Mean
768452|NCT00703846|Secondary|Mean Change From Baseline for the Emotional Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 52 (or Early Termination)|Skindex-29 is a 3-component (symptomatic, emotional, and functional) self-administered questionnaire (comprised of 30 questions) used to comprehensively measure the complex effects of skin diseases on a participant's quality of life. For the emotional component, participants were asked to answer 10 questions based on a 5-point scale concerning their feelings over the past 4 weeks about the skin condition that has bothered them the most: 1, never; 2, rarely; 3, sometimes; 4, often; 5, all the time. The Emotional Score is the sum of the 10 question scores; total score ranges from 10 to 50.|Baseline and Week 52 (or Early Termination)|Safety Analysis Set. Participants who submitted incomplete questionnaires (missing values) were excluded from the analysis.||units on a scale||Standard Deviation|Mean
768453|NCT00703846|Secondary|Mean Change From Baseline for the Symptomatic Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 52 (or Early Termination)|Skindex-29 is a 3-component (symptomatic, emotional, and functional) self-administered questionnaire (comprised of 30 questions) used to comprehensively measure the complex effects of skin diseases on a participant's quality of life. For the symptomatic component, participants were asked to answer 7 questions based on a 5-point scale concerning their feelings over the past 4 weeks about the skin condition that has bothered them the most: 1, never; 2, rarely; 3, sometimes; 4, often; 5, all the time. The Symptomatic Score is the sum of the 7 question scores; total score ranges from 7 to 35.|Baseline and Week 52 (or Early Termination)|Safety Analysis Set. Participants who submitted incomplete questionnaires (missing values) were excluded from the analysis.||units on a scale||Standard Deviation|Mean
768454|NCT00703846|Secondary|Mean Change From Baseline for the Global Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 52 (or Early Termination)|Skindex-29 is a 3-component (symptomatic, emotional, and functional) self-administered questionnaire (comprised of 30 questions) used to comprehensively measure the complex effects of skin diseases on a participant's quality of life. Participants were asked to answer questions based on a 5-point scale concerning their feelings over the past 4 weeks about the skin condition that has bothered them the most: 1, never; 2, rarely; 3, sometimes; 4, often; 5, all the time. The Global Score is the sum of the 30 question scores; total score ranges from 30 to 150.|Baseline and Week 52 (or Early Termination)|Safety Analysis Set. Participants who submitted incomplete questionnaires (missing values) were excluded from the analysis.||units on a scale||Standard Deviation|Mean
768455|NCT00703846|Secondary|Median Number of Flare Days|The median number of flare days for all participants was calculated based on data self-reported in diaries that participants kept during the study. The median number of flares for all participants was calculated based on data self-reported in diaries that participants kept during the study. A flare day is defined as a day on which flare signs and symptoms for seborrheic dermatitis (erythema, scaling, and pruritus of the target area) occurred.|From baseline through 52 weeks|Safety Analysis Set||flare days||Full Range|Median
768456|NCT00703846|Secondary|Median Number of Flares|The median number of flares for all participants was calculated based on data self-reported in diaries that participants kept during the study. A flare is defined as a clinical diagnosis and presentation of seborrheic dermatitis that shows as an erythematous, thin, scaly patch with a greasy sandpaper texture that varies depending on disease severity. Flares are commonly seen on the scalp, nasal folds, eyebrows, glabella, upper eyelids, retroauricular/external ear canal, and midchest areas.|From baseline through 52 weeks|Safety Analysis Set||flares||Full Range|Median
768457|NCT00703846|Secondary|Mean Change From Baseline in Investigator’s Static Global Assessment (ISGA) at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination)|"This seborrhoeic dermatitis-specific ISGA scale (range=0-4) is used to assess skin condition severity without considering changes over time (static). 0=clear, except for minor residual discoloration; 1-4=majority of lesions have average scaling/erythema scores of 1-4, respectively. 1=almost clear, occasional fine scale, faint erythema/barely perceptible plaque thickness; 2= mild, fine scale with light coloration/mild plaque elevation; 3=moderate, coarse scale with moderate red coloration/moderate plaque thickness; 4=severe, thick tenacious scale with deep coloration/severe plaque thickness."|Baseline and Weeks 4, 8, 16, 26, 39, and 52 (or early termination)|Safety Analysis Set. Participants withdrew from the study as the study progressed, and data were missing for some participants. There were no imputation methods used for missing data for any analysis.||units on a scale||Standard Deviation|Mean
768458|NCT00703846|Secondary|Mean Change From Baseline in Skin Assessments for Pruritus at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination)|Mean change from baseline was calculated as the Week 4, 8, 16, 26, 39, and 52 (or Early Termination) value minus the baseline value. The grading scale for pruritis ranges from 0 to 4; 0=No itching; 1=Minimal: rarely aware of itching; 2=Mild: only aware of itching at times; only present when relaxing; not present when focused on other activities; 3=Moderate: often aware of itching; annoying; sometimes disturbs sleep and daytime activities; 4=Severe: constant itching; distressing; frequent sleep disturbance; interferes with activities. Pruritus is defined as an itching/scratching sensation.|Baseline and Weeks 4, 8, 16, 26, 39, and 52 (or early termination)|Safety Analysis Set. Participants withdrew from the study as the study progressed, and data were missing for some participants. There were no imputation methods used for missing data for any analysis.||units on a scale||Standard Deviation|Mean
768459|NCT00703846|Secondary|Mean Change From Baseline in Skin Assessments for Scaling at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination)|Mean change from baseline in skin assessments for scaling was calculated as the Week 4, 8, 16, 26, 39, and 52 (or Early Termination) value minus the baseline value. The grading scale for scaling ranges from 0 to 4; 0=Normal skin with rare fine scale; 1=Minimal: occasional fine scales over less than 10% of the lesions; 2=Mild: fine scales predominate; 3=Moderate: coarse scales predominate; 4=Severe: thick tenacious scales predominate. Scaling of skin is the loss of the outer layer of the epidermis in large, scale-like flakes.|Baseline and Weeks 4, 8, 16, 26, 39, and 52 (or early termination)|Safety Analysis Set. Participants withdrew from the study as the study progressed, and data were missing for some participants. There were no imputation methods used for missing data for any analysis.||units on a scale||Standard Deviation|Mean
768460|NCT00703846|Secondary|Mean Change From Baseline in Skin Assessments for Erythema at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination)|Mean change from baseline was calculated as the Week 4, 8, 16, 26, 39, and 52 (or early termination) value minus the baseline value. The grading scale for erythema ranges from 0 to 4; 0=Normal skin without erythema; may have residual hyper/hypopigmentation; 1=Faint erythema; may have residual hyper/hypopigmentation; 2=Light red erythema; may have residual hyper/hypopigmentation; 3=Moderate red coloration; 4=Dusky to deep red coloration. Erythema was defined as redness of the skin caused by increased blood circulation in the capillaries found in the deeper layers of the skin.|Baseline and Weeks 4, 8, 16, 26, 39, and 52 (or early termination)|Safety Analysis Set. Participants withdrew from the study as the study progressed, and data were missing for some participants. There were no imputation methods used for missing data for any analysis.||units on a scale||Standard Deviation|Mean
768461|NCT00703846|Primary|Number of Participants With Any Adverse Event (AE)|"An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, which does not necessarily have a causal relationship with the treatment. For a list of all adverse events occurring at or above a frequency threshold of 5% during the course of the study, see the table entitled Other (Non-Serious) Adverse Events."|From baseline through 52 weeks|Safety Analysis Set: all participants who had used the study product at least once||participants|||Number
768462|NCT00703885|Primary|Voxelwise Brain Imaging Data|Analysis of data not completed.|Post-Rx Administration||||||
768463|NCT00703885|Primary|Effect of Alprazolam Versus Placebo on BOLD fMRI During Emotion Processing|Analysis not completed.|Same Day||||||
768464|NCT00703911|Other Pre-specified|Percentage of Bleed Treatments Resulting in Effective Pain Relief by Initial Dose (Spontaneous Bleed Episodes)|"Percentage of bleeds with effective pain relief within 9 hours of first injection of activated recombinant human factor VII. Patient reported assessments were sorted into 3 sub-categories: Better = pain resolved or decreased substantially; Same = no change; Worsened = pain worsening."|within 9 hours after first injection|Analysis set is spontaneous bleed episodes treated with any initial dose||percentage of bleed episodes|||Number
768465|NCT00703911|Other Pre-specified|Percentage of Bleed Treatments Resulting in Effective Pain Relief by Initial Dose (All Bleed Episodes)|"Percentage of bleeds with effective pain relief within 9 hours of first injection of activated recombinant human factor VII. Patient reported assessments were sorted into 3 sub-categories: Better = pain resolved or decreased substantially; Same = no change; Worsened = pain worsening."|within 9 hours after first injection|Analysis set is all bleed episodes, regardless of bleed type or initial dose level||percentage of bleed episodes|||Number
768466|NCT00703911|Other Pre-specified|Percentage of Bleed Treatments Resulting in Effective Haemostasis (Cessation of Bleed) by Dose Level (Spontaneous Bleed Episodes)|"Percentage of bleeds with effective haemostasis within 9 hours of first injection of activated recombinant human factor VII. Patient reported assessments were sorted into 3 sub-categories: effective = bleed resolved or substantially improved; partially effective = bleed with some improvement; ineffective = bleed with no change or with worsening."|within 9 hours after first injection|Analysis set is spontaneous bleed episodes treated with any initial dose||percentage of bleed episodes|||Number
768467|NCT00703911|Other Pre-specified|Percentage of Bleed Treatments Resulting in Effective Haemostasis (Cessation of Bleed) by Dose Level (All Bleed Episodes)|"Percentage of bleeds with effective haemostasis within 9 hours of first injection of activated recombinant human factor VII. Patient reported assessments were sorted into 3 sub-categories: effective = bleed resolved or substantially improved; partially effective = bleed with some improvement; ineffective = bleed with no change or with worsening."|within 9 hours after first injection|Analysis set is all bleed episodes, regardless of bleed type or initial dose level||percentage of bleed episodes|||Number
768468|NCT00703911|Secondary|Adults' Health Related Quality of Life (Haemo-QoL-A): Overall Score|The adult Haemo-QoL-A is a specific multidimensional validated and reliable questionnaire used to assess quality of life in patients with haemophilia. Scores are reported on a 0 to 100 scale—higher scores indicate more impairment.|Baseline (week 0) and and registry discontinuation (up to 28 months)|A subset of adult subjects above 16 years included in the study that completed the questionnaire at baseline and/or at discontinuation||scores on a scale||Standard Deviation|Mean
768469|NCT00703911|Secondary|Childrens' Health Related Quality of Life (Haemo-QoL): Overall Score|The Haemo-QoL is a specific multidimensional validated and reliable questionnaire used to assess quality of life in patients with haemophilia. Scores are reported on a 0 to 100 scale—higher scores indicate more impairment.|Baseline (week 0) and and registry discontinuation (up to 28 months)|A subset of paediatric subjects age 4 to 16 (inclusive) included in the study that completed the questionnaire at baseline and/or at discontinuation||scores on a scale||Standard Deviation|Mean
768470|NCT00703911|Secondary|Overall Time to Cessation/Achievement of Haemostasis (Spontaneous Bleed Episodes)|Median time to achievement of haemostasis/bleed cessation calculated using Kaplan Meier life table methods. If approximately 50% or less of bleeds achieved the endpoint in a given initial dose subgroup, the median cannot be calculated and it is reported as not applicable.|duration of bleed episode|Analysis set is spontaneous bleed episodes treated with any initial dose, excluding bleed episodes treated with more than one dose for which > 24 hours between the 1st and 2nd dose was reported (bleed episodes with > 24 hours between 1st and 2nd rFVIIa dose likely reflects treatment of re-bleeding or prophylactic/maintenance dosing)||minutes||95% Confidence Interval|Median
768967|NCT00708214|Secondary|Progression-free Survival (PFS)|PFS was defined as the time from the first treatment to the occurrence of tumour progression or death, whichever came first. Progression was assessed according to RECIST criteria.|Baseline till progression, death or data cut-off (04 Jan 2010)|TS||days||95% Confidence Interval|Median
768471|NCT00703911|Secondary|Overall Time to Cessation of Bleed/Achievement of Haemostasis (Spontaneous Bleed Episodes)|Median time to achievement of haemostasis/bleed cessation calculated using Kaplan Meier life table methods. If approximately 50% or less of bleeds achieved the endpoint in a given initial dose subgroup, the median cannot be calculated and it is reported as not applicable|duration of bleed episode|Analysis set is spontaneous bleed episodes treated with any initial dose||minutes||95% Confidence Interval|Median
768472|NCT00703911|Secondary|Overall Time to Cessation of Bleed/Achievement of Haemostasis (All Bleed Episodes)|Median time to achievement of haemostasis/bleed cessation calculated using Kaplan Meier life table methods. If approximately 50% or less of bleeds achieved the endpoint in a given initial dose subgroup, the median cannot be calculated and it is reported as not applicable|duration of bleed episode|Analysis set is all bleed episodes, regardless of bleed type or initial dose level||minutes||95% Confidence Interval|Median
768473|NCT00703911|Secondary|Percentage of Bleed Treatments Resulting in Patient Satisfaction With Ease of Use (Spontaneous Bleed Episodes)|"Rate of ease of use related to activated recombinant human factor VII on a 7-point Likert scale. Completion of questionnaire was voluntary. A Likert scale is an ordered, multiple choice questionnaire from which respondents choose one option that best aligns with their view of the particular outcome being measured. Scale answers ranged from extremely difficult to extremely easy. The percentage of bleed episodes for which patients reported extremely easy, very easy or easy is presented."|duration of bleed episode|Analysis set is spontaneous bleed episodes treated with any initial dose||percentage of bleed episodes|||Number
768474|NCT00703911|Secondary|Percentage of Bleed Treatments Resulting in Patient Satisfaction With Ease of Use (All Bleed Episodes)|"Rate of ease of use related to activated recombinant human factor VII on a 7-point Likert scale. Completion of questionnaire was voluntary. A Likert scale is an ordered, multiple choice questionnaire from which respondents choose one option that best aligns with their view of the particular outcome being measured. Scale answers ranged from extremely difficult to extremely easy. The percentage of bleed episodes for which patients reported extremely easy, very easy or easy is presented."|duration of bleed episode|Analysis set is all bleed episodes, regardless of bleed type or initial dose level||percentage of bleed episodes|||Number
768475|NCT00703911|Secondary|Percentage of Bleed Treatments Resulting in Patient Satisfaction With Symptom Relief (Spontaneous Bleed Episodes)|"Patient rate of satisfaction with symptom relief for the bleed episode overall on a 7-point Likert scale. Completion of questionnaire was voluntary. A Likert scale is an ordered, multiple choice questionnaire from which respondents choose one option that best aligns with their view of the particular outcome being measured. Scale answers ranged from extremely satisfied to extremely dissatisfied. The percentage of bleed episodes for which patients reported extremely satisfied, very satisfied or satisfied is presented."|duration of bleed episode|Analysis set is spontaneous bleed episodes treated with any initial dose||percentage of bleed episodes|||Number
768476|NCT00703911|Secondary|Percentage of Patients Reporting Satisfaction With Symptom Relief (All Bleed Episodes)|"Patient rate of satisfaction with symptom relief for the bleed episode overall on a 7-point Likert scale. Completion of questionnaire was voluntary. A Likert scale is an ordered, multiple choice questionnaire from which respondents choose one option that best aligns with their view of the particular outcome being measured. Scale answers ranged from extremely satisfied to extremely dissatisfied. The percentage of bleed episodes for which patients reported extremely satisfied, very satisfied or satisfied is presented."|duration of bleed episode|Analysis set is all bleed episodes, regardless of bleed type or initial dose level||percentage of bleed episodes|||Number
768477|NCT00703911|Secondary|Total Exposure (Cumulative Dose) to Activated Recombinant Human Factor VII (Spontaneous Bleed Episodes)|The median total cumulative dose required to treat individual bleed episodes.|individual bleed episode|Analysis set is spontaneous bleed episodes. Excludes bleeds episodes with > 24 hours between 1st and 2nd rFVII dose where total cumulative dose recorded likely reflects treatment of re-bleeding or prophylactic/maintenance dosing, and 2 bleed episodes categorised as CNS that would not meet criteria of mild to moderate spontaneous bleed episodes||mcg/kg||Full Range|Median
768478|NCT00703911|Secondary|Total Exposure (Cumulative Dose) to Activated Recombinant Human Factor VII (All Bleed Episodes)|The median total cumulative dose required to treat individual bleed episodes.|individual bleed episode|Analysis set is all bleed episodes, regardless of bleed type or initial dose level. Excludes bleeds episodes with greater than 24 hours between 1st and 2nd rFVII dose where total cumulative dose recorded likely reflects treatment of re-bleeding or prophylactic/maintenance dosing||mcg/kg||Full Range|Median
768479|NCT00703911|Secondary|Total Number of Injections (Spontaneous Bleed Episodes)|The median number of injections required to treat individual bleed episodes.|individual bleed episode|Analysis set is spontaneous bleed episodes treated with any initial dose||injections||Inter-Quartile Range|Median
768480|NCT00703911|Secondary|Total Number of Injections (All Bleed Episodes)|The median number of injections required to treat individual bleed episodes.|individual bleed episode|Analysis set is all bleed episodes, regardless of bleed type or initial dose level||injections||Inter-Quartile Range|Median
768481|NCT00703911|Secondary|Percentage of Bleed Treatments Resulting in Effective Pain Relief by Time Point (Spontaneous Bleed Episodes)|Effective pain relief at 3 different time points for spontaneous bleeds. Patient reported outcomes are reported over 1 hour, 3 hours and 6 hours.|1 hour, 3 hours and 6 hours, respectively, after first injection|Analysis set is spontaneous bleed episodes treated with any initial dose||percentage of bleed episodes|||Number
768482|NCT00703911|Secondary|Percentage of Bleed Treatments Resulting in Effective Pain Relief by Time Point (All Bleed Episodes)|Effective pain relief at 3 different time points for all bleeds. Patient reported outcomes are reported over 1 hour, 3 hours and 6 hours.|1 hour, 3 hours and 6 hours, respectively, after first injection|Analysis set is all bleed episodes, regardless of bleed type or initial dose level||percentage of bleed episodes|||Number
768483|NCT00703911|Secondary|Percentage of Bleed Treatments Resulting in Effective Haemostasis (Cessation of Bleeds) by Time Point (Spontaneous Bleed Episodes)|Effective haemostasis at 3 different time points for all bleeds. Patient reported outcomes are reported over 1 hour, 3 hours and 6 hours.|1 hour, 3 hours and 6 hours, respectively, after first injection|Analysis set is spontaneous bleed episodes treated with any initial dose||percentage of bleed episodes|||Number
769527|NCT00714493|Secondary|Percent of Patients Who Acheived EULAR Response at Week 10 and Maintained Through Week 26 Without Infliximab Dose Increase|Percent of patients who achieved EULAR response at Week 10 and maintained through Week 26 without infliximab dose increase|Week 26|||percentage|||Number
768484|NCT00703911|Secondary|Percentage of Bleed Treatments Resulting in Effective Haemostasis (Cessation of Bleeds) by Time Point (All Bleed Episodes)|Effective haemostasis at 3 different time points for all bleeds. Patient reported outcomes are reported over 1 hour, 3 hours and 6 hours.|1 hour, 3 hours and 6 hours, respectively, after first injection|Analysis set is all bleed episodes, regardless of bleed type or initial dose level||percentage of bleed episodes|||Number
768485|NCT00703911|Primary|Percentage of Bleed Treatments Resulting in Effective Pain Relief (Spontaneous Bleed Episodes)|The percentage of participants with effective pain relief. Pain relief was a subjective assessment made by the patient during treatment of a bleed episode.|within 9 hours of first injection|Analysis set is spontaneous bleed episodes treated with any initial dose||percentage of bleed episodes|||Number
768486|NCT00703911|Primary|Percentage of Bleed Treatments Resulting in Effective Pain Relief (All Bleed Episodes)|The percentage of participants with effective pain relief. Pain relief was a subjective assessment made by the patient during treatment of a bleed episode.|within 9 hours of first injection|Analysis set is all bleed episodes, regardless of bleed type or initial dose level||percentage of bleed episodes|||Number
768487|NCT00703911|Primary|Percentage of Bleed Treatments Resulting in Effective Bleed Resolution (Spontaneous Bleed Episodes)|"The percentage of bleed treatments successfully resulting in bleed resolution. Analysis only considers the patient's opinion of effectiveness at 9 hours, with a rating of Effective considered as successful treatment."|within 9 hours of first injection|Analysis set is spontaneous bleed episodes treated with any initial dose||percentage of bleed episodes|||Number
768488|NCT00703911|Primary|Percentage of Bleed Treatments Resulting in Effective Bleed Resolution (All Bleed Episodes)|"The percentage of bleed treatments successfully resulting in bleed resolution. Analysis only considers the patient's opinion of effectiveness at 9 hours, with a rating of Effective considered as successful treatment."|within 9 hours of first injection|Analysis set is all bleed episodes, regardless of bleed type or initial dose level||percentage of bleed episodes|||Number
768489|NCT00703924|Secondary|Rate of Relapse|"Relapse is defined as enlargement of the index lesion compared to previous measurement at any time after day 50 (+ 7 days) or not demonstrating CCR by study day 180. CCR was compared using uncorrected Fisher’s exact test.
Confidence intervals (95%) were constructed on the difference between the two group proportions. The log-rank test was used to compare the time to complete re-epithelialization of the index lesion without relapse. Cure of all subjects lesions was also compared using the Fisher’s exact test. To adjust for baseline differences in the treatment groups, a linear model for the proportion of subjects achieving CCR was fit for each baseline variable of interest with covariates for treatment group and the baseline variable."|180 days|||Participants|||Count of Participants
768490|NCT00703924|Secondary|Final Cure Rate by Subject of All Lesions|Final cure rate by subject was determined using the Fisher's exact test. To adjust for baseline differences in the treatment groups, a linear model for the proportion of subjects achieving CCR was fit for each baseline variable of interest with covariates for treatment group and the baseline variable.|180 days|||Participants|||Count of Participants
768491|NCT00703924|Secondary|Time to Complete Re-epithelialization of the Index Lesion Ulcer Without Relapse|100% re-epithelialization of the index lesion without having had a relapse. The log-rank test was used to compare the time to complete re-epithelialization.|180 days|Days to 100% re-epithelialization of index lesion. Volunteer Identification Number (VIN). VINs 17, 72, and 109 failed to meet 100% re-epithelialization||Participants|||Count of Participants
768492|NCT00703924|Primary|Safety of WR 279,396 (AEs and SAEs)|Safety was evaluated on each day during daily administration of the topical products. Subjects were observed and questioned for the occurrence of solicited local side effects (eg, pain, erythema, edema) and solicited systemic side effects (eg, vertigo, tinnitus, diminished hearing). Non-solicited AE evaluations included spontaneous reports from subjects and clinical observations.|180 days|All solicited local and systemic AEs and SAEs including immediate and delayed reactions that occurred during this study are summarized.||Adverse Events|||Number
768493|NCT00703924|Primary|Complete Clinical Response (CCR) of Lesion at Days 50, 100 and 180 (+7 Days)|CCR is defined as at least 50% reduction, from baseline, in index lesion area of ulceration at study days 50, 100 and 180 (+ 7 days). Randomized subjects were compared using the uncorrected Fisher's exact test. Confidence intervals (95%) were constructed on the difference between the two group proportions. The log-rank test was used to compare the time to complete re-epithelialization of the index lesion without relapse. Cure of all subjects lesions was also compared using the Fisher’s exact test. To adjust for baseline differences in the treatment groups, a linear model for the proportion of subjects achieving CCR was fit for each baseline variable of interest with covariates for treatment group and the baseline variable. The Breslow-Day test was used to examine whether the effect of WR 279,396 varied between subgroups|180 days|||Participants|||Count of Participants
768494|NCT00703937|Primary|Safety, as Defined by the Occurence of Serious Adverse Events (SAE's), of FCM Compared to SMC|Safety, as defined by the occurence of serious adverse events (SAE's), of FCM compared to SMC in the treatment of IDA in subjects who were not dialysis dependent|First administration of FCM, or Day 0 for SMC subjects, through end of study (Day 42) or 28 days after the last dose of study drug (FCM or SMC) whichever was longer|||participants|||Number
768495|NCT00703963|Secondary|Mean Number of INR Tests Performed||baseline to 3 months|||INR tests||Standard Deviation|Mean
768496|NCT00703963|Secondary|Mean Percentage of INR Tests Within the Therapeutic Range||baseline to 3 months|||percentage of tests||Standard Deviation|Mean
768497|NCT00703963|Primary|Mean Percentage of Time in Therapeutic Range||baseline to 3 months|||percentage of time||Standard Deviation|Mean
768498|NCT00703976|Secondary|2-year Overall Survival (OS)|Two-year OS is an estimated percentage of participants still living at two years after the start of study treatment.|2 years of follow-up after closing accrual|||percentage of participants||95% Confidence Interval|Number
768499|NCT00703976|Primary|2-year Progression-free Survival (PFS)|Two-year PFS is an estimated percentage of participants without disease progression (locoregional or distant) at two years after the start of study treatment. Progression was defined using Response Evaluation Criteria In Solid Tumors (RECIST v1.0), as: at least a 20% (and at least 5 millimeters) increase in the sum of the diameters of target lesions, or the appearance of one or more new lesions.|18 months to patient accrual and 2 years of follow-up after closing accrual.|||percentage of participants||90% Confidence Interval|Number
768501|NCT00704132|Primary|Change From Baseline in Glucose 5-Hour Incremental AUC at Week 6|Participants underwent the 5-hour meal test prior to randomization (baseline) and was repeated at the conclusion of the 6-week double-blind study period. The change from baseline in Glucose 5-Hour Incremental AUC at Week 6 is computed as the difference between the Week 6 measurement and the baseline measurement.|Baseline and Week 6|Full-Analysis-Set (FAS) population, which includes all randomized participants who had a baseline value, received at least one dose of randomized treatment, and had a measurement at Week 6.||mg*hr/dL||95% Confidence Interval|Least Squares Mean
768502|NCT00704171|Primary|Percentage of Subjects Remaining Air Leak Free From Skin Closure to Discharge|Sub-analysis by pre-randomization grade of air leak. Grade 1= countable air bubbles, Grade 2= stream of bubbles, Grade 3= coalesced bubbles|30 days|Analysis by grade of air leak.Grade 1= countable air bubbles, Grade 2= Stream of bubbles, Grade 3 = Coalesced bubbles.||Percentage of participants|||Number
768503|NCT00704171|Secondary|Duration of Hospitalization||30 days|||hours||Standard Deviation|Median
768504|NCT00704171|Secondary|Duration of Chest Drainage||30 days|||hours||Standard Deviation|Median
768505|NCT00704171|Secondary|Time From Skin Closure to Last Observable Air Leak.||30 days|||hours||95% Confidence Interval|Median
768506|NCT00704171|Secondary|Percentage of Subjects for Whom Intra-operative Air Leak Sealing Success is Achieved.|Success is defined as no presence of air leak intra-operatively.|Intra-operatively, time of study procedure|||Percentage of participants|||Number
768507|NCT00704171|Primary|Percentage of Subjects Remaining Air Leak Free From Time of Skin Closure to Hospital Discharge.||30 days|||Percentage of participants|||Number
768508|NCT00704184|Secondary|Mean Log Change From Baseline in HCV RNA|The mean changes from baseline in log10 HCV RNA in each vaniprevir group was compared against control treatment at Week 4.|Baseline and Week 4|The Per Protocol population included all participants who did not have clinically important deviations from protocol-specified criteria. Only participants with an HCV RNA result at the Week 4 time point were included in the analysis.||Log10 IU/mL||Standard Deviation|Mean
768509|NCT00704184|Secondary|Number of Participants With ≥3-log10 Decrease in HCV RNA|The number of participants with at least a 3-log10 decrease from baseline in HCV RNA following 4 weeks of treatment with Placebo or Vaniprevir.|Baseline and Week 4|The Per Protocol population included all participants who did not have clinically important deviations from protocol-specified criteria. Only participants with an HCV RNA result at the Week 4 time point were included in the analysis.||Number of Participants|||Number
768510|NCT00704184|Secondary|Number of Participants With ≥2-log10 Decrease in HCV RNA|The number of participants with at least a 2-log10 decrease from baseline in HCV RNA following 4 weeks of treatment with Placebo or Vaniprevir.|Baseline and Week 4|The Per Protocol population included all participants who did not have clinically important deviations from protocol-specified criteria. Only participants with an HCV RNA result at the Week 4 time point were included in the analysis.||Number of Participants|||Number
768511|NCT00704184|Primary|Number of Participants Discontinuing From Study Therapy Due to AEs|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study therapy, whether or not considered related to the use of the product.|Day 1 to Day 28|The Safety Population consists of all randomized participants who received at least 1 dose of study therapy||Participants|||Number
768512|NCT00704184|Primary|Number of Participants Experiencing an Adverse Event (AE)|The number of participants experiencing AEs in each treatment group was monitored during the Vaniprevir/Placebo treatment (Day 1 to Day 28) and safety follow-up (Day 29 to Day 42) periods.|Up to Day 42|The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.||Participants|||Number
768513|NCT00704184|Primary|Percentage of Participants Achieving RVR|Rapid Viral Response (RVR) was declared if Hepatitis C Virus (HCV) ribonucleic acid (RNA) was undetectable at Week 4.|Week 4|The Per Protocol population included all participants who did not have clinically important deviations from protocol-specified criteria. Only participants with an HCV RNA result at the Week 4 time point were included in the analysis.||Percentage of Participants|||Number
768514|NCT00704340|Secondary|Percentage of Subjects With a Cerebrospinal Fluid (CSF) Leak|"As determined from clinical diagnosis by one of the following methods:
CSF leak or pseudomeningocele related surgical intervention (i.e., breaking skin) within 30 days post-operation
CSF leak confirmation by diagnostic testing within 30 days post-operation
CSF leak confirmation by clinical evaluation including physical examination of the surgical site within 30 days post-operation"|30 days|||percent of subjects||95% Confidence Interval|Number
768515|NCT00704340|Secondary|Percentage of Subjects With Post-operative Surgical Site Infections||30 days|||percent of subjects||95% Confidence Interval|Number
768516|NCT00704340|Primary|Percentage of Subjects With Surgical Wound Complications, Central Nervous System Events, and Neurosurgical Complications Related to Unplanned Intervention or Return to the Operating Room.|"Surgical Wound Complications;
Superficial incisional surgical site infection (SSI)
Deep incisional SSI
Organ/Space SSI
Late incisional infection: superficial incisional infection that occurs more than 31 but less than 38 days after surgery
Poor wound healing
Central Nervous System Events;
Cerebrospinal Fluid (CSF) leak
Hydrocephalus
Bacterial meningitis
Aseptic meningitis
In addition, any complication related to the neurosurgical procedure that required unplanned intervention (i.e., minimally invasive procedures) or return to the operating room was counted."|30 days|||percent of subjects||95% Confidence Interval|Number
768517|NCT00704353|Primary|Number of Participants With Treatment-emergent Serious Adverse Events (SAE's)||through 30 days after the last dose of study drug (FCM or SMC for the treatment of IDA)|||participants|||Number
768527|NCT00704405|Primary|Number of Participants Discontinuing From Study Treatment Due to AEs|The number of non-cirrhotic participants withdrawing from study treatment due to AEs during the active Vaniprevir/PBO treatment and 14-day follow-up periods was monitored for each treatment regimen.|Up to 48 weeks|The All-Patients-as-Treated (APaT) population was employed for safety analyses. The APaT population consists of all randomized non-cirrhotic patients who received at least one dose of study treatment.||Number of participants|||Number
768710|NCT00699400|Primary|Thawing Cycle Level Live Birth Rate|Live birth rate per thawing cycle was calculated from the number of live births divided by the number of oocytes thawed less the number of embryos cryopreserved from thawed oocytes, averaged over all thawing cycles.|Birth of one or more live babies|Live birth rate per thaw cycle(%)||% of oocytes thawed per cycle|Participants|95% Confidence Interval|Mean
768711|NCT00699413|Secondary|Hunger||Measured at baseline and 12 weeks||||||
768518|NCT00704379|Secondary|Neuroimaging Variables (i.e., Fractional Anisotropy [FA] of Frontal White Matter Such as the Cingulate Gyrus)|"FA is a measured obtained from Diffusion Tensor Imaging, an image modality of Magnetic Resonance Imaging (MRI). FA is a unitless index. Range: 0 to 1. FA describes the degree of anisotropy of a diffusion process. A value of zero means that diffusion is unrestricted or equally restricted in all directions. A value of one means that diffusion occurs only along one axis and is fully restricted along all other directions. In the context of this study, FA measures the integrity of the cingulate gyrus white matter. Higher FA values reflect higher integrity of the cingulate gyrus white matter tract. Average FA values for the right and left cingulate gyri were summed.
One aim of this project was to identify predictors of the occurrence of mood disturbances during the first 6 months following TBI. The hypothesis for this aim was that patients who develop a mood or anxiety disorder six months after TBI present at baseline with lower FA of the cingulate gyrus than those who do not."|Baseline|Of the 94 participants randomized, only 61 participants had an MRI and were included in the analysis of this study aim.||unitless index||Standard Deviation|Mean
768519|NCT00704379|Secondary|Social Functioning Examination Total Score|The Social Functioning Examination (SFE) is a semi-structured interview that measures social functioning in areas such as interpersonal relationships, work adjustment, use of community resources and satisfaction with living environment. Range: 0 to 1. Higher scores denote lower levels of social functioning.|6 months after TBI|Out of the 80 participants who completed the trial, only 63 completed SFE at this evaluation time.||units on a scale||Standard Deviation|Mean
768520|NCT00704379|Secondary|Memory Function Composite|This outcome measures memory function and is a composite of five standardized scores: Brief Visuospatial Memory Test - Revised, Delayed Recall and California Verbal Learning Test, Short Delay Free Recall Number Correct and Discriminability, and Long Delay Free Recall Number Correct and Discriminability. Standardized scores (i.e., z-scores) for each test of this composite were obtained by subtracting the mean raw score of all participants to the raw score of each participant and dividing the result by the standard deviation of the raw scores of all participants. The composite score was obtained by averaging the z-scores of the four memory tests mentioned previously. Range: -3 to 3. Higher scores represent better memory function.|6 months following traumatic brain injury|Out of the 80 participants who completed the trial, only 61 completed all the tests necessary to calculate the composite score at this evaluation time.||z-scores||Standard Deviation|Mean
768521|NCT00704379|Secondary|Iowa Gambling Task Score|The Iowa Gambling Task (IGT) evaluates decision making ability. During IGT subjects have to choose between decks of cards which yield high immediate gain but larger future loss (i.e., long term loss), and decks which yield lower immediate gain but a smaller future loss (i.e., a long term gain). The task consists of four decks of cards: A, B, C, and D. The goal in the task is to maximize profit. Subjects are required to make a series of card selections. The decks A and B are long term loss decks and the decks C and D are long term gain decks. The IGT Score reported is the combination of the raw score for each deck combined in the following way: (C+D) - (A+B). The range for this score is: -100 to 100. Higher values of this score indicate better decision making ability.|6 months after TBI|Out of the 80 participants who completed the trial, only 64 completed IGT at this evaluation time.||units on a scale||Standard Deviation|Mean
768522|NCT00704379|Secondary|Total Community Integration Questionnaire Scores|The Community Integration Questionnaire (CIQ) is intended as a brief, reliable measure of an individual’s level of integration into the home and community following traumatic brain injury. Total CIQ scores were used as the outcome measure. Range: 0 to 25. Higher scores indicate higher levels of integration into the home and community following TBI.|6 months after TBI|Out of the 80 participants who completed the trial, only 68 completed CIQ at this evaluation time.||units on a scale||Standard Deviation|Mean
768523|NCT00704379|Primary|Time to Onset of Diagnostic and Statistical Manual (DSM) IV Defined Mood and Anxiety Disorders Associated With Traumatic Brain Injury (TBI)|"Following the DSM-IV (now updated by the DSM-5), depressive disorders associated with TBI are categorized as Mood Disorder Due to Another Medical Condition with subtypes: 1) With major depressive-like episode (if the full criteria for a major depressive episode [MDE] are met) or 2) With depressive features (prominent depressed mood but full criteria for a MDE are not met); and 3) with mixed features (e.g. significant irritability, pressured speech and formal thought disorder).
On the other hand, bipolar and related disorders due to TBI are subdivided in: 1) with manic or hypomanic like episode; 2) with manic features; and 3) with mixed features.
A similar conceptual framework has been used to define Anxiety Disorder due to another Medical Condition, in this case, TBI. According to DSM-IV/DSM-5, such diagnosis can be made when, besides an evident pathophysiological relationship with TBI, panic attacks or generalized anxiety are the prominent features of the clinical presentation."|6 months after TBI|||weeks||Standard Error|Mean
768524|NCT00704405|Secondary|Percentage of Participants Achieving SVR24 After 24 Weeks of Vaniprevir 600 mg b.i.d.|The percentage of participants achieving SVR24 after the 24-week Vaniprevir 600 mg b.i.d. regimen at Week 48 was compared to the control regimen.|Week 48|The Full Analysis Set (FAS) population consists of all non-cirrhotic participants who received at least 1 dose of study treatment, have post-dose endpoint data, and have baseline data for measures that require baseline data.||Percentage of participants|||Number
768525|NCT00704405|Secondary|Percentage of Participants Achieving cEVR|The percentage of non-cirrhotic participants with complete early viral response (cEVR; undetectable HCV RNA at Week 12) was determined for each Vaniprevir dose. Since each of the Vaniprevir 600 mg arms had the same treatment history at this point in the study, the data were pooled for analysis.|Up to Week 60|The Full Analysis Set (FAS) population consists of all non-cirrhotic participants who received at least 1 dose of study treatment, have post-dose endpoint data, and have baseline data for measures that require baseline data. The 3 Vaniprevir 600 mg b.i.d. arms were combined in this analysis.||Percentage of participants|||Number
768526|NCT00704405|Secondary|Percentage of Participants Achieving SVR24 Following Treatment With Vaniprevir 300 mg b.i.d.|The percentage of non-cirrhotic participants treated with Vaniprevir 300 mg b.i.d. with undetectable HCV RNA 24 weeks after completing treatment was determined.|72 weeks|The Full Analysis Set (FAS) population consists of all non-cirrhotic participants who received at least 1 dose of study treatment, have post-dose endpoint data, and have baseline data for measures that require baseline data.||Percentage of participants|||Number
768712|NCT00699413|Secondary|Percent Body Fat||Measured at baseline and 12 weeks||||||
768713|NCT00699413|Secondary|Insulin Activity||Measured at baseline and 12 weeks||||||
768714|NCT00699413|Primary|Body Mass Index / Weight||measured at baseline and 12 weeks|||kg/m^2||Standard Deviation|Mean
768528|NCT00704405|Primary|Number of Participants Experiencing an Adverse Event (AE)|The number of non-cirrhotic participants experiencing AEs during the active Vaniprevir/PBO treatment and 14-day follow-up periods was monitored for each treatment regimen. An AE was defined as any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a Sponsor product, whether or not considered related to the use of the product.|Up to 73 weeks|The All-Patients-as-Treated (APaT) population was employed for safety analyses. The APaT population consists of all non-cirrhotic randomized patients who received at least one dose of study treatment.||Number of participants|||Number
768529|NCT00704405|Primary|Percentage of Participants Achieving SVR24 Following Treatment With Vaniprevir 600 mg b.i.d.|The percentage of non-cirrhotic participants with undetectable Hepatits C virus (HCV) ribonucleic acid (RNA) 24 weeks after completing treatment was determined for each Vaniprevir 600 mg b.i.d. and control regimen. Results for Vaniprevir 300 mg are presented as a Secondary Outcome Measure.|Up to 72 weeks|The Full Analysis Set (FAS) population consists of all non-cirrhotic participants who received at least 1 dose of study treatment, have post-dose endpoint data, and have baseline data for measures that require baseline data.||Percentage of participants|||Number
768530|NCT00704418|Secondary|Number of Participants That Are Pain Free|Participant description of being pain free (Score of none)taken from patient questionnaire, Ocular Comfort Grading Assessment with multiple possible responses|Day 1|LOCF Analysis, ITT Population||participants|||Number
768531|NCT00704418|Primary|Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero|Participants with SOIS of 0. Scale: 0=0 cells (complete absence); 0.5=1-5 cells; 1=6-15 cells (very slight); 2=16-25 cells (moderate); 3=26-50 cells (marked); 4=>50 cells (intense)|Day 15|Last Observation Carried Forward Analysis(LOCF), ITT Population||participants|||Number
768532|NCT00704522|Primary|Average Length of Treatment With PegIntron/Rebetol||After start of treatment|Number of participants who received study drug||Weeks||Standard Deviation|Mean
768533|NCT00704522|Primary|Number of Participants Who Complete Treatment With PegIntron Pen/Rebetol Therapy for Hepatitis C When Administered With a Patient Assistance Program||24 or 48 weeks (depending on genotype) and 24 weeks of follow up|All participants||Participants|||Number
768534|NCT00704535|Primary|Tolerability as Measured by Subject Self-assessment|Evaluation of the overall tolerability of ezetimibe as measured by subject self-assessment|28 days after Visit 1|||subjects|||Number
768535|NCT00704535|Primary|Safety as Measured by Outcome of Adverse Events|To evaluate overall safety of ezetimibe as measured by outcome of adverse events|28 days after Visit 1|||adverse events|||Number
768536|NCT00704535|Primary|Safety as Measured by Dose Adjustment Upon Incidence of an Adverse Event|To evaluate the overall safety of ezetimibe as measured by action taken by the investigator upon incidence of an adverse event|28 days after Visit 1|||adverse event|||Number
768537|NCT00704535|Primary|Safety as Measured by Adverse Event Relatedness to Study Drug as Reported by the Investigator.|To evaluate the overall safety of ezetimibe as measured by adverse event relatedness to study drug as reported by the investigator.|28 days after Visit 1|||adverse events|||Number
768538|NCT00704535|Primary|Safety as Measured by Severity of Adverse Events as Determined by the Investigator|To evaulate the safety of ezetimibe as measured by severity of adverse events, as determined by the investigator|28 days after Visit 1|||adverse events|||Number
768539|NCT00704535|Primary|Safety as Measured by Number and Type of Adverse Events.|Evaluation of the overall safety of ezetimibe as measured by the number and type of adverse events.|28 days after Visit 1|||adverse events|||Number
768540|NCT00704535|Secondary|To Evaluate the Efficacy of Ezetimibe in Lowering Serum Cholesterol Levels 28 Days After Visit 1 (Baseline)|Change in mean total cholesterol values|28 days after Visit 1|All enrolled subjects who had both baseline and post-treatment samples collected for cholesterol measurements||mg/dL||Standard Deviation|Mean
768541|NCT00704535|Primary|Safety as Measured by Number of Subjects With at Least One Adverse Event|Evaluation of the overall safety of ezetimibe as measured by number of subjects who experienced at least one adverse event|28 days after Visit 1|||subjects|||Number
768542|NCT00704717|Primary|Satisfaction of Patients Receiving PegIntron Pen Plus Rebetol Therapy, Assessed by a Survey.|The scale used in the patient questionnaire ranged from 0 (dissatisfied) to 8 (very satisfied). Patients evaluated the training received from the medical staff, ease of the preparation and administration of the medication, and the personal experience when using the PegIntron pen.|The survey was administered during a follow-up visit in the clinic, at any point during the 48-week treatment.|||Units on a scale||Standard Deviation|Mean
768543|NCT00704730|Secondary|Biochemical Response Carcinoembryonic Antigen (CEA) %|For each on-treatment tumor marker assessment from each subject, the biochemical response of CEA was determined based on percent increase or decrease from baseline. Best biochemical response over the course of treatment was determined from evaluation of each subject’s time point response data. Biochemical response: Complete Response (CR)- Decrease in tumor marker into normal range from baseline value; Partial Response (PR)- Decrease of >50% from baseline value when baseline value is above normal range; Stable Disease (SD)- No more than a 50% increase and no more than a 50% decrease from baseline value above normal range; Progressive Disease (PD)- Increase of >50% from baseline value when baseline value is above normal range / or increase from low or normal range at baseline to above normal range; Not Evaluable (NE)- Missing baseline value / or baseline value is not elevated and response is not Progressive Disease (PD) / or response can not be determined due to change in assay format.|Serum tumor markers CEA evaluated from blood samples collected at screening and every 12 weeks (± 5 days from randomization) until date of first documented progression or date of death from any cause, whichever came first, assessed for up to 34 months.|For the CEA measure the analysis population differs from the Intent To Treat (ITT) population of 219 XL184 and 111 Placebo. One subject did not provide samples for CEA. The biomarker analysis was based on available samples, not on ITT.||% of participants|||Number
768577|NCT00705081|Primary|Number of Participants Reporting Adverse Events|Safety and tolerability of LDL lowering with co-administration therapy as measured by the number of participants reporting adverse events (AE). (AE defined as any untoward medical occurrence or unfavorable and unintended sign in a subject administered the pharmaceutical product whether or not considered related to the use of that product.)|4-6 weeks after the first visit|All participants enrolled||Participants|||Number
768578|NCT00705107|Secondary|Average Length of Treatment.||Assessed at the end of treatment. The prescribed treatment duration was 48 weeks.|||weeks||Standard Deviation|Mean
768544|NCT00704730|Secondary|Biochemical Response Calcitonin (CTN) %|For each on-treatment tumor marker assessment from each subject, the biochemical response of CTN was determined based on percent increase or decrease from baseline. Best biochemical response over course of treatment was determined from evaluation of subject’s time point response data. Biochemical response criteria: Complete Response (CR) - decrease in tumor marker into normal range from baseline value; Partial Response (PR) - decrease of >50% from baseline value when baseline value is above normal range; Stable Disease (SD) - no more than a 50% increase and no more than a 50% decrease from baseline value above normal range; Progressive Disease (PD) - increase of >50% from baseline value when baseline value is above normal range / or increase from low or normal range at baseline to above normal range; Not Evaluable (NE) - missing baseline value / or baseline value is not elevated and response is not PD / or response can not be determined due to change in assay format.|Serum tumor markers CTN evaluated from blood samples collected at screening and every 12 weeks (±5 days from randomization) until date of first documented progression or date of death from any cause, whichever came first, assessed for up to 34 months.|Population was intent to treat (ITT), randomized to either XL184 or placebo. For the CTN measure the analysis population differs from the ITT population of 219 XL184 and 111 Placebo. Three subjects did not provide samples for CTN. The biomarker analysis was based on available samples, not on ITT.||% participants|||Number
768545|NCT00704730|Secondary|Duration of Objective Response (OR): Independent Radiology Committee (IRC) Determined|For those subjects with Independent Radiology Committee (IRC) determined Objective Response Rate (ORR), the amount of time from documentation of Objective Response (OR) until Progressive Disease (PD) by mRECIST or death due to any cause.|From time of first documentation of Objective Response (OR), confirmed at a later visit ≥28 days later as Progressive Disease (PD) as defined by mRECIST or death due to any cause, assessed up to 34 months.|The primary analysis of Objective Response Rate (ORR) was performed among the subset of Intent To Treat (ITT) subjects with measurable disease at baseline and was based upon response as determined by the Independent Review Committee (IRC.) Subjects who did not have post-baseline adequate tumor assessments were counted as nonresponders.||months||95% Confidence Interval|Median
768546|NCT00704730|Secondary|Objective Response Rate (ORR)|The proportion of subjects with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) as determined by the Independent Review Committee (IRC.) Per Response Evaluation Criteria in Solid Tumor Criteria (mRECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR) disappearance of all target lesions; Partial Response (PR) ≥ 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) ≥ 20% increase in the sum of the longest diameter of target lesions. Overall Response Rate: ORR=CR +PR|Assessed at the same time as primary analysis of Progression Free Survival (PFS) data. Assessed at baseline and every 12 weeks until Progressive Disease (PD) up to 34 months.|The primary analysis Objective Response Rate (ORR) was performed among subset of Intent To Treat (ITT) subjects with measurable disease at baseline (N = 208 cabozantinib, N = 104 placebo) based upon response determined by Independent Radiology Committee (IRC.) Subjects without post-baseline adequate tumor assessments - counted as nonresponders.||% of participants|||Number
768547|NCT00704730|Secondary|Overall Survival (OS) With XL184 Compared With Placebo|Duration of Overall Survival (OS) from the time of randomization to death due to any cause. A Kaplan-Meier analysis was performed to estimate the median.|The pre-specified interim analysis of Overall Survival (OS) was assessed at 44% of required events. Includes data up to 15June2011. As of this date, the number of deaths required to conduct the primary analysis had not been reached.|Intent to treat (ITT) randomized to either XL184 or placebo||months||95% Confidence Interval|Median
768548|NCT00704730|Primary|Progression-Free Survival (PFS)|The duration of Progression-Free Survival (PFS) using progression events as determined by Independent Review Committee (IRC) per mRECIST, or death due to any cause. The analysis was conducted after at least 315 subjects were randomized and at least 138 events were observed.|Treatment period consisted of 4-week cycles with radiologic tumor assessment every 12 weeks from date of randomization until date of first documented PD or date of death from any cause, whichever came first, assessed up to 34 months.|Intent to Treat (ITT) 330 subjects were randomized and were included in the analysis. A Kaplan-Meyer analysis was performed to estimate the median.||months||95% Confidence Interval|Median
768549|NCT00704769|Primary|General Clinical Response of Desloratadine Syrup Based on the Physician's Judgments|Physicians judged the subjects as good, excellent, fair, or poor.|Minimum of 7 days after initiation of desloratadine|||Participants|||Number
768550|NCT00704769|Primary|Adverse Events|An adverse event was defined in the protocol to include any untoward medical occurrence or unfavorable and unintended sign in a subject administered a pharmaceutical product (at any dose). Additionally, any event that is associated with or observed in conjunction with a product overdose (whether accidental or intentional) or a product abuse and/or withdrawal were also considered an adverse event. The investigator assessed the relationship of any adverse event as either unlikely, possibly, or probably related to the use of study drug based on available information and protocol guidelines.|Minimum of 7 days after initiation of desloratadine|||Participants|||Number
768551|NCT00704808|Primary|Median Progression Free Survival After Primary Surgical Treatment, Concomitant and Adjuvant Chemotherapy With Temozolomide, for Patients With Newly Diagnosed Glioblastoma Multiforme||After primary surgical treatment and concomitant and adjuvant chemotherapy with temozolomide|Intent-to-Treat population||Months||Standard Error|Median
768552|NCT00704847|Primary|Pain Subscore Change From Baseline Over 24 Months as Assessed by Western Ontario and McMaster Universities Arthritis (WOMAC) Index|WOMAC is a self-administered set of standardized questionnaires to evaluate the condition of patients with osteoarthritis of the knee. The subject marks on a scale (1-100) the pain associated with performing each daily activity listed in the questionnaire. 0 is no pain (best), 100 is extreme pain (Worst). The total pain sub score for the questions are then calculated. Total possible minimum sub score is 0, maximum is 500. The final outcome is the absolute change from baseline to 24 months. If the outcome is less that 0 there is improvement (less pain).|Change from baseline to 24 months|The number of participants analysed for this outcome is the intent-to-treat (ITT) population. ITT is the number of randomized subjects who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the ITT analysis.||Units on a scale||Standard Deviation|Mean
768553|NCT00704847|Secondary|• Bone & Cartilage Metabolism Biochemical Marker Change. • Questionnaires to Assess Function, Stiffness, Pain, Physical Activity, and Quality of Life • Knee Disease Progression Assessed by MRI||From baseline to 24 months||||||
768554|NCT00704847|Primary|Joint Space Width (JSW) in the Medial Tibia-femoral Knee Joint in the Signal Knee Measured by X-ray Change From Baseline Over 24 Months|The signal knee was chosen prior to randomization based on which knee met the inclusion and exclusion criteria. The JSW is the space measured in mm between the 2 bones in the knee joint and this is assessed by x-ray. The JSW decreases with disease progression. The lower limit for participation in the trial were 2 mm JSW. There were no upper limit as long as inclusion and exclusion criteria were met. The outcome was measured as a change in JSW from baseline to month 24.|Change from baseline to 24 months|The number of participants analysed for this outcome is the intent-to-treat (ITT) population. ITT is the number of randomized subjects who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the ITT analysis.||mm||Standard Deviation|Mean
768555|NCT00704912|Secondary|Prevalence of Metabolic Syndrome||Baseline, 4 months|||participants|||Number
768556|NCT00704912|Secondary|Change in Weight|Change from baseline to end of the 4-month intervention.|Baseline, 4 months|||kg||95% Confidence Interval|Least Squares Mean
768557|NCT00704912|Secondary|Ovulation Rate||Up to 4 months|||total number of ovulations|Clomiphene Treatment Cycles||Number
768558|NCT00704912|Primary|Live Birth Rate||Participants were followed for 4 months of attempted conception and those who conceived were then followed for the duration of their pregnancy, approximately 9 months.|||participants|||Number
768559|NCT00704938|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse events module.|5 months|||Participants|||Number
768560|NCT00704938|Primary|Clinical Response (Complete Response + Partial Response)|Clinical response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is disappearance of all lesions. Partial response is a 30% decrease in the sum of the longest diameter (LD) of target lesions.|5 months|||Participants|||Number
768561|NCT00704964|Primary|Number of Participants With Adherence to Therapy According to Physician Approximation|Adherence was based on physiciant's clinical judgment.|Up to 48 weeks for HCV genotype 1 or 4 participants and up to 24 weeks for HCV genotype 2 or 3|||Participants|||Number
768562|NCT00704964|Primary|Number of Participants With Biometrical Adherence to Therapy|Adherence was defined as participants receiving at least 80% of the planned PegIntron doses, or at least 80% of the planned Rebetol doses, or participants concluding at least 80% of the planned duration of their treatment, or all three conditions.|Up to 48 weeks for Hepatitis C Virus (HCV) genotype 1 or 4 participants and up to 24 weeks for HCV genotype 2 or 3|||Participants|||Number
768563|NCT00705003|Secondary|The Change From Baseline on the HAM-A at Week 6|"The 14-item HAM-A scale rates the patient’s level of anxiety based on feelings of anxiousness, tension, and depression; any phobias, sleep disturbance, or difficulty in concentrating; the presence of genitourinary, cardiovascular, respiratory, autonomic or somatic symptoms; and the interviewer’s assessment of the patient’s appearance and behavior during the interview. Each item is to be scored on a 5 point scale with 0 reflecting no symptoms and 4 reflecting symptoms of maximum symptom severity (Hamilton 1960).
The items are summed to find the total score. The total minimum score is 0 units on a scale and the total maximum score is 56 units on a scale, where higher scores indicate more severe anxiety. Change from baseline is calculated as baseline score minus Week 6 score. A positive change indicates improvement."|Week 0 and Week 6|Efficacy analysis were completed for the MITT Population: Subjects included in the MITT analysis received at least 1 dose of study drug and provided at least 1 post-baseline CGI-I assessment. Subjects included in the analysis of safety received at least 1 dose of study drug.||units on a scale||Standard Error|Mean
768564|NCT00705003|Secondary|The Change From Baseline in the Quick Inventory of Depressive Symptomatology – 16 Item Self-Report (QIDS-SR16) at Week 6|"The QIDS-SR16 is a 16 question, patient rated scale that assesses the 9 Diagnostic & Statistical Manual of Mental Disorders-IV-Text Revision criterion diagnostic symptom domains including sad mood, concentration, self criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance, decrease or increase in appetite or weight, & psychomotor agitation or retardation. Each item is measured on a scale of 0 to 3. To find total score, you enter:
highest score from items 1-4 (Sleep Items)
item 5 score
highest score from items 6-9 (appetite/weight)
item 10 score
item 11 score
item 12 score
item 13 score
item 14 score
highest score from items 15-16 (psychomotor) These 9 scores are summed to find total score. Total minimum score is 0 units on a scale & total maximum score is 27 units, where higher scores indicate more severe depression. Change from baseline is calculated as baseline score minus Week 6 score. A positive change indicates improvement"|Baseline and Week 6|Efficacy analysis were completed for the MITT Population: Subjects included in the MITT analysis received at least 1 dose of study drug and provided at least 1 post-baseline CGI-I assessment. Subjects included in the analysis of safety received at least 1 dose of study drug.||units on a scale||Standard Error|Mean
768565|NCT00705003|Secondary|The Change From Baseline in the IDS-C30 at Week 6|The Inventory of Depressive Symptomatology is a 30-item scale that assesses criteria including mood, concentration, self criticism, suicidal ideation, interest, energy/fatigue, sleep, decrease/increase in appetite or weight, psychomotor agitation or retardation, diurnal mood variation, capacity for pleasure, sexual interest, bodily aches and pains, panic or phobic symptoms, digestive problems, interpersonal rejection sensitivity, and leaden paralysis. Items are scored on a 4 point scale with 0 reflecting no symptoms and 3 reflecting symptoms of maximum severity. The total score is calculated by summing the scores from 28 of the 30 items. Only one of items 11 or 12, and only one of items 13 or 14 are scored. The minimum score is 0 and the maximum score is 84. A score of 84 indicates maximum severity of depressive symptoms. Change from baseline is calculated as the baseline score minus the post-baseline score. A positive change indicates improvement.|Week 0 and Week 6|Efficacy analysis were completed for the MITT Population: Subjects included in the MITT analysis received at least 1 dose of study drug and provided at least 1 post-baseline CGI-I assessment. Subjects included in the analysis of safety received at least 1 dose of study drug.||units on a scale||Standard Error|Mean
768579|NCT00705107|Primary|Number of Subjects Who Completed Treatment.||Assessed at the end of the 48-week treatment.|All participants||Participants|||Number
768580|NCT00705146|Secondary|Pain|AUSCAN 3.1 pain subscale. Possible score range is 0 to 50. Lower scores indicate less pain. Change scores are reported (baseline to 4 weeks splint wear) for each of the two splints.|4 weeks|Pooled all participants for the phase they wore the hybrid, then comfort cool splints, respectively. Mean change scores are reported||units on a scale||95% Confidence Interval|Mean
768566|NCT00705003|Secondary|The Change From Baseline in the CGI-S at Week 6|"Clinical Global Impression (CGI) is a standardized, clinician-rated assessment designed to allow the clinician to rate severity of illness, change over time, and pharmacologic treatment effects with consideration of the patient’s clinical condition and the severity of side effects experienced (Guy 1976). The CGI-S is a sub-scale of the Clinical Global Impression. The Investigator was asked: “Considering your total clinical experience with patients with this particular population, please assign a rating to how mentally ill the subject is at this time.”
Possible responses include the following:
0: Not Assessed
Normal, not ill at all
Borderline mentally ill
Mildly ill
Moderately ill
Markedly ill
Severely ill
Among the most extremely ill patients. The change from baseline CGI-S score was calculated as the baseline CGI-S score minus the post-baseline CGI-S score, such that a positive change indicated an improvement from baseline."|Baseline and Week 6|Efficacy analysis were completed for the MITT Population: Subjects included in the MITT analysis received at least 1 dose of study drug and provided at least 1 post-baseline CGI-I assessment. Subjects included in the analysis of safety received at least 1 dose of study drug.||units on a scale||Standard Deviation|Mean
768567|NCT00705003|Primary|The Score on the Clinical Global Impression-Improvement (CGI-I) at Week 6|"Clinical Global Impression (CGI) is a standardized, clinician-rated assessment designed to allow the clinician to rate severity of illness, change over time, and pharmacologic treatment effects with consideration of the patient’s clinical condition and the severity of side effects experienced (Guy 1976). Specifically, it consists of two global subscales: Global Improvement (CGI-I) Severity of Illness (CGI-S)
The CGI-I was administered at Weeks 2, 4 and 6. The CGI-I evaluation was performed with instruction to “Rate the patient’s total improvement whether or not, in your judgment, it is due entirely to drug treatment.” The Investigator was asked “Compared to the patient’s condition at the Baseline visit, please assign a rating to how much the patient changed.” Responses for the CGI-I evaluation included the following categories:
0: Not Assessed
Very much improved
Much improved
Minimally improved
No change
Minimally worse
Much worse
Very much worse"|Week 6|142 subjects were enrolled and randomized in the study. 8 of these subjects were randomized but never received study drug. Subjects included in the MITT analysis received at least 1 dose of study drug and provided at least 1 post-baseline CGI-I assessment. Subjects included in the analysis of safety received at least 1 dose of study drug.||units on a scale||Standard Error|Mean
768568|NCT00705016|Secondary|Safety - Number of Participants Experiencing Any Adverse Event|Please refer to Adverse Events section for details of individual serious adverse events and other adverse events|Time from first assessment of CR or PR until PD, death or last tumor assessment, reported between day of first participant randomized, 03 July 2009, until cut-off date (03 September 2011)|Safety population included all participants who were administered any dose of the trial medication, that is, cilengitide, cisplatin, 5-FU, or cetuximab.||participants|||Number
768569|NCT00705016|Secondary|Duration of Response|Duration of response is defined as the time from the first assessment of CR or PR until the date of the first occurrence of progressive disease (PD), or until the date of death.|Time from first assessment of CR or PR until PD, death or last tumor assessment, reported between day of first participant randomized, 03 July 2009, until cut-off date (03 September 2011)|ITT population included all participants who were randomized to trial treatment.||months||95% Confidence Interval|Median
768570|NCT00705016|Secondary|Time to Treatment Failure (TTF)|TTF is defined as the time from randomization to date of the first occurrence of; progression, discontinuation of treatment due to progression or adverse event, start of new anticancer therapy, withdrawal of consent, or death (within 84 days of last tumor assessment). Participants without event are censored on the date of last tumor assessment.|Time from randomization to disease progression, death or last tumor assessment, reported between day of first participant randomized, 03 July 2009, until cut-off date (03 September 2011)|ITT population included all participants who were randomized to trial treatment.||months||95% Confidence Interval|Median
768571|NCT00705016|Secondary|Disease Control Rate|The disease control rate is defined as the percentage of participants having achieved confirmed CR, PR or stable disease (SD) as best overall response according to radiological assessments (based on RECIST Version 1.0).|Evaluations will be performed every 6 weeks until progression reported between day of first participant randomized, 03 July 2009, until cut-off date (03 September 2011)|ITT population included all participants who were randomized to trial treatment.||percentage of participants||95% Confidence Interval|Number
768572|NCT00705016|Secondary|Best Overall Response (BOR) Rate|The BOR rate is defined as the percentage of the participants having achieved confirmed complete response (CR) or partial response (PR) as the best overall response according to radiological assessments (based on RECIST Version 1.0).|Evaluations will be performed every 6 weeks until progression reported between day of first participant randomized, 03 July 2009, until cut-off date (03 September 2011)|ITT population included all participants who were randomized to trial treatment.||percentage of participants||95% Confidence Interval|Number
768573|NCT00705016|Secondary|Overall Survival (OS) Time|The OS time is defined as the time from randomization to death. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whichever is earlier.|Time from randomization to death, reported between day of first participant randomized, 03 July 2009, until cut-off date (03 September 2011)|ITT population included all participants who were randomized to trial treatment.||months||95% Confidence Interval|Median
768574|NCT00705016|Primary|Progression-free Survival (PFS) Time: Investigator Read|The PFS is defined as the duration from randomization until radiological progression (based on response evaluation criteria in solid tumors [RECIST] Version 1.0) or death due to any cause. Only deaths within 84 days of last tumor assessment are considered. Participants without event are censored on the date of last tumor assessment. Investigator read is the assessment of all imaging by the treating physician at the local trial site.|Time from randomization to disease progression, death or last tumor assessment, reported between day of first participant randomized, 03 July 2009, until cut-off date (03 September 2011)|Intention-to-treat (ITT) population included all participants who were randomized to trial treatment.||months||95% Confidence Interval|Median
768575|NCT00705081|Primary|Participants Achieving Low-density Lipoprotein-cholesterol (LDL-C) Target Levels With Co-administration Therapy|Achievement of LDL-C target levels as determined by physician|4-6 weeks after the first visit|All patients enrolled||Participants|||Number
768576|NCT00705081|Primary|Intensity of Adverse Events Reported|Intensity of adverse events reported after co-administration therapy|4-6 weeks after the first visit|All participants enrolled||Participants|||Number
768581|NCT00705146|Primary|Hand Function|Hand Function was measured with the Australian Canadian Osteoarthritis Hand Index 3.1 (AUSCAN). The AUSCAN is a self-report tool with 15 questions in 3 subscales: pain, function, joint stiffness, and uses an 11-point (0-10) numerical rating scale. The AUSCAN function subscale has 9 items regarding level of difficulty in performing daily tasks such as opening a jar, turning a doorknob, wringing out a washcloth. Possible scores range from 0 to 90. Mean change scores are reported (baseline compared to 4 weeks splint use). Higher scores indicate worse function.|4 weeks|Pooled participants from both arms from the phase they wore the hybrid splint, then from the phase they wore the comfort cool splint. Mean change scores are reported.||units on a scale||95% Confidence Interval|Mean
768582|NCT00705159|Secondary|Change From Baseline in Total Blepharoconjunctivitis Graded at Visit 3|Change from baseline in total blepharoconjunctivitis grade to visit 3(day 7) measured on a scale of 0-4. 0 (none), 1 (minimal/trace), 2 (mild), 3 (moderate), and 4 (severe). Grade range from 0-32.|Baseline to Day 7|Study eye ITT population, subjects with non-missing data||Score on a scale||Standard Deviation|Mean
768583|NCT00705159|Secondary|Change From Baseline in Total Blepharoconjunctivitis Graded at Visit 2|Change from baseline in total blepharoconjunctivitis grade to visit 2(day 3) measured on a scale of 0-4. 0 (none), 1 (minimal/trace), 2 (mild), 3 (moderate), and 4 (severe). Grade range from 0-32.|Baseline to Day 3|Study eye, ITT population, non-missing data||Score on a scale||Standard Deviation|Mean
768584|NCT00705159|Primary|Change From Baseline in the Total Blepharoconjunctivitis Grade.|Change from baseline to visit 4 in the total blepharoconjunctivitis grade. Graded on a scale of 0-4, 0 (none), 1 (minimal/trace), 2 (mild), 3 (moderate), and 4 (severe). Grade range from 0-32.|Baseline to 15 days|Study eye, ITT Population, Non-missing data||Score on a scale||Standard Deviation|Mean
768585|NCT00705224|Secondary|Percentage of Participants Who Achieved Early Virological Response as Assessed at Visit 2 by HCV Genotype and Presence of Insulin-Resistance at Baseline|Early Virological response (EVR) was assessed at 12 weeks after treatment start (Visit 2) by HCV genotype (I, II, III, or other) and presence of insulin-resistance at baseline (defined as HOMA-IR >3) to investigate the percentage of participants who achieved EVR. EVR was defined as a substantial (greater than 2 log10) decrease in viral load (measured as International Units/milliliter) and/or negative Polymerase chain reaction (PCR)-based viral load qualitative result as assessed at visit 2 of the study.|Week 12 after treatment start|Completer set for the primary analysis (N=223) included all participants who were administered at least one dose of the study treatment and provided the SVR data at end of study. Of the 223 participants in this population, 210 participants demonstrated early virological response (N=158 and N=50). 2 participants of the 210 had missing values.||Percentage of Participants|||Number
768586|NCT00705224|Secondary|Percentage of Participants Who Demonstrated Virological Relapse as Assessed at End of Study by HCV Genotype and Presence of Insulin-Resistance at Baseline|Virological relapse (VR) was assessed at the end of the study (Visit 4) by HCV genotype (I, II, III, or other) and presence of insulin-resistance at baseline (defined as HOMA-IR >3) to investigate the percentage of participants who demonstrated VR. VR was defined as undetectable plasma HCV-RNA (RFT +) at end of treatment (Visit 3- considered Week 24 or Week 48 after treatment start depending on treatment duration), but lost RFT (considered sustained non-Responders) at end of study (Visit 4- considered Week 48 or Week 72 depending on a treatment duration of 24 or 48 weeks respectively).|24 weeks following completion of 24 or 48 weeks of therapy|Completer set for the primary analysis (N=223) included all participants who were administered at least one dose of the study treatment and provided the SVR data at end of study. Of the 223 participants in this population, 29 participants demonstrated virological relapse (N=18 and N=11) and were therefore included in this analysis.||Percentage of Participants|||Number
768587|NCT00705224|Secondary|Percentage of Participants Who Achieved Response Following Treatment as Assessed at End of Treatment by HCV Genotype and Presence of Insulin-Resistance at Baseline|Response following treatment (RFT) was assessed at the end of treatment (Visit 3) by HCV genotype (I, II, III, or other) and presence of insulin-resistance at baseline (defined as HOMA-IR >3) to investigate the presence or absence of RFT. RFT was defined as undetectable plasma HCV-RNA at end of treatment. Visit 3 was considered Week 24 or Week 48 after treatment start depending on treatment duration.|Week 24 or 48 after treatment start|Completer set for the primary analysis (N=223) included all participants who were administered at least one dose of the study treatment and provided the SVR data at end of study. Of the 223 participants in this population, 208 achieved RFT (N=156 and N=51) and were therefore included in this analysis. 1 participant of the 208 had missing values.||Percentage of Participants|||Number
768588|NCT00705224|Secondary|Percentage of Participants Who Achieved Sustained Virological Response as Assessed at End of Study by HCV Genotype and Presence of Insulin-Resistance at Baseline|SVR was assessed at the end of the study (Visit 4) by HCV genotype (I, II, III, or other) and presence of insulin-resistance at baseline (defined as Homeostasis model assessment - of insulin-resistance [HOMA-IR] >3) to investigate the presence or absence of SVR. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of treatment. Visit 4 was considered Week 48 or Week 72 depending on a treatment duration of 24 or 48 weeks respectively.|24 weeks following completion of 24 or 48 weeks of therapy|Completer set for the primary analysis (N=223) included all participants who were administered at least one dose of the study treatment and provided the SVR data at end of study. Of the 223 participants in this population, 181 achieved SVR (N=140 and N=40) and were therefore included in this analysis. 1 participant of the 181 had missing values.||Percentage of Participants|||Number
768589|NCT00705224|Primary|Percentage of Participants Who Achieved Sustained Virological Response as Assessed at End of Study|Sustained Virological response (SVR) was assessed at the end of the study (Visit 4) to investigate the presence or absence of SVR. SVR was defined as undetectable plasma hepatitis C virus RNA (HCV-RNA) at 24 weeks after termination of treatment. Visit 4 was considered Week 48 or Week 72 depending on a treatment duration of 24 or 48 weeks respectively.|24 weeks following completion of 24 or 48 weeks of therapy|Completer set for the primary analysis included all participants who were administered at least one dose of the study treatment and provided the SVR data at end of study.||Percentage of Participants||95% Confidence Interval|Number
768626|NCT00698646|Secondary|Change From Baseline to Week 4, 8, 12 and 16 in Office Cuff Mean Sitting Diastolic Blood Pressure (MSDBP)||Baseline and Weeks 4, 8, 12 and 16|Intent to treat (ITT), Last observation carried forward||mm Hg||Standard Deviation|Mean
768627|NCT00698646|Primary|Change From Baseline to Week 4 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)||Baseline and Week 4|Intent to treat (ITT), Last observation carried forward||mm Hg||Standard Deviation|Mean
768590|NCT00705250|Primary|Determine the Overall Response Rate (RR) to Bendamustine HCL in Patients With Relapsed and Primary Refractory HL.|The percentage of evaluable participants who achieved either a complete response (CR) or partial response (PR). CR Disappearance of all evidence of disease. (a) FDGavid or PET positive prior to therapy; mass of any size permitted if PET negative (b) Variably FDG-avid or PET negative; regression to normal size on CT. PR Regression of measurable disease and no new sites. > or = to 50% decrease in SPD of up to 6 largest dominant masses; no increase in size of other nodes (a) FDG-avid or PET positive prior to therapy; one or more PET positive at previously involved site (b) Variably FDG-avid or PET negative; regression on CT.|up to 3 years|||percentage of evaluable participants|||Number
768591|NCT00705263|Primary|Number of Participants Satisfied With the PegIntron Pen, Including the Assessment of the Device Accuracy and Ease of Use.|Participants were asked to evaluate the training they received in the proper use of the pen, the preparation and injection of the medicine, and to provide their subjective impressions about the use of the PegIntron pen. Satisfaction was defined as score 5 or above on a 7-point grading scale.|After 4 weeks of treatment.|Patients with chronic hepatitis C treated with PegIntron pen plus Rebetol||Satisfied Participants|||Number
768592|NCT00705289|Primary|Baseline Raw DAS28 by Previous Anti-Tumor Necrosis Factor (Anti-TNF) Therapy|Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between DAS28 and baseline characteristic is reported in the statistical analysis.|At Baseline|All efficacy evaluable subjects (n=662) included subjects with early RA not yet treated with anti-TNF (n=76), subjects with established RA not yet treated with anti-TNF (n=447), and subjects with RA who failed or did not tolerate another anti-TNF (n=123). Some subjects could not be classified into any subgroup due to missing diagnosis dates.||Score on a scale||Standard Deviation|Mean
768593|NCT00705289|Primary|Baseline Raw DAS28 by Country of Residence|Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between Baseline Raw DAS28 and Baseline Characteristic is reported in the statistical analysis.|At Baseline|||Score on a scale||Standard Deviation|Mean
768594|NCT00705289|Primary|Baseline Raw DAS28 by Gender|Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between Baseline Raw DAS28 and Baseline gender (see Baseline Characteristics) is reported in the statistical analysis.|At Baseline|Efficacy evaluable population included all subjects who were enrolled and received at least one dose of study medication and with non-missing efficacy data at Baseline and at least one follow-up visit.||Score on a scale||Standard Deviation|Mean
768595|NCT00705289|Primary|Baseline Raw DAS28 by Time Since Diagnosis|Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between Baseline Raw DAS28 and time since diagnosis is reported in the statistical analysis.|At Baseline|||Score on a scale||Standard Deviation|Mean
768596|NCT00705289|Primary|Baseline Raw Disease Activity Score for 28 Joint Swollen and Tender Joint Count (DAS28) by Age|Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between Baseline Raw DAS28 and Baseline age (see Baseline Characteristics) is reported in the statistical analysis.|At Baseline|Efficacy evaluable population included all subjects who were enrolled and received at least one dose of study medication and with non-missing efficacy data at Baseline and at least one follow-up visit.||Score on a scale||Standard Deviation|Mean
768597|NCT00705341|Secondary|Predictive Value of Methacholine Challenge Test for Phase 1|Predictive value of methacholine challenge test in phase 1 for asthmatics and nonasthmatic controls|one time|||% predictive value||95% Confidence Interval|Number
768598|NCT00705341|Primary|Methacholine Challenge Test Result for Phase 2|Presence and degree of airway hyperresponsiveness assessed by methacholine challenge test post-diluent baseline (PC20) after medication holds; PC20 is the methacholine dose at which the amount of air expired in the first second during a forced expiratory maneuver is reduced by 20%; value represents change in baseline to 4 weeks|weeks 0, 4|There was a significant period effect in the percentage change in post diluent baseline (PC20) for high- and low-dose depending upon the order in which the doses were administered. In order to remove the effect of the order, we compared the high- and low-dose MCT results exclusively during the first cross over.||mg/ml||Full Range|Geometric Mean
768599|NCT00705367|Secondary|Long-term Period: Number of Participants With Abatacept-specific Antibodies|Antiabatacept antibodies in human serum were assayed using a validated electrochemiluminescent immunoassay during the period of known analyte stability.|Day15 to 56 days post last dose of the long-term period|All participants who received at least 1 dose of abatacept and had an immunogenicity test result.||Participants|||Number
768600|NCT00705367|Secondary|Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests (Continued)|ULN=upper limit of normal; preRX=pretreatment: ALP (U/L): >2*ULN, or if preRX>ULN, use >3*preRX; AST (U/L): >3*ULN, or if preRX>ULN, use >4*preRX; ALT (U/L): >3X*ULN, or if preRX>ULN, use >4*preRX; GGT (/L): >*ULN, or if preRX>ULN, use >3*preRX; bilirubin (mg/dL): >2*ULN, or if preRX>ULN, use >4*preRX; BUN (mg/dL):>2*preRX; sodium: <.95*LLN, >1.05*ULN, <.95* preRX if <LLN preRX, >1.05*preRX if >ULN preRX; >ULN if <LLN preRX, <LLN if >ULN preRX; potassium: chloride: calcium: phosphorous:|Days 15 to 56 days post last dose of the long-term period|All participants who received at least 1 dose of study medication.||Participants|||Number
768601|NCT00705367|Secondary|Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests (Continued)|preRX=pretreatment; LLN=lower limit of normal; ULN=upper limit of normal. Glucose (mg/dL): <65 or >220. Glucose, fasting(mg/dL): <0.8*LLN or >1.5* ULN; if preRX<LLN, use <0.8*preRX or >ULN; if preRX>ULN, use >2.0*preRX or <LLN. Protein, total (g/dL): <0.9*LLN or >1.1*ULN; if preRX<LLN, use 0.9*preRX or >ULN if preRX >ULN, use 1.1*preRX or <LLN. Albumin (g/dL): <0.9*LLN, or if preRX<LLN use <0.75*preRX. Uric acid (mg/dL): >1.5*ULN; if preRX>ULN use >2*preRX. Protein, urine: if missing preRX, use>=2; if >=4; if preRX=0 or 0.5, use >=2; if preRX=1, use >=3, or if preRX=2 or 3, use >= 4. Glucose, urine: if preRX missing, use >=2; if >=4, or if preRX=0 or 0.5 use >=2,or if preRX=1, use >=3, or if preRX=2 or 3 use >=4. Blood, urine: if preRX missing, use>= 2, or if >=4, or if preRX=0 or 0.5, use >=2, or if preRX=1, use >=3; if preRX=2 or 3 use >=4. WBC, urine (hpf): if missing preRX, use>= 2, or if >= 4, or if preRX =0 or 0.5 use >=2, or if preRX=1 use >=3, or if preRX=2 or 3 use >=4.|Days 15 to 56 days post last dose of the long-term period|All participants who received at least 1 dose of study medication.||Participants|||Number
768602|NCT00705367|Secondary|Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests|preRX=pretreatment; LLN=lower limit of normal; ULN=upper limit of normal. hemoglobin (g/dL): >3g/dL drop from preRX; hematocrit (%): <0.75*preRX; erythrocytes (*10^6 c/uL): <0.75*preRX; platelet count (*10^9 c/L): <0.67*LLN or >1.5*ULN, or <100,000/mm^3 or if preRX<LLN, use <0.5*preRX and <100,000/mm^3; leukocytes (*10^3 c/uL): <0.75*LLN, >1.25*ULN, <0.8*preRX if preRX <LLN or >1.2*preRX if preRX >ULN; >ULN if preRX <LLN, <LLN if >ULN preRX; neutrophils+bands (*10^3 c/uL): if value <1.00*10^3 c/uL; lymphocytes (*10^3 c/uL): if value <0.750*10^3 c/uL or if value >7.50*10^3 c/uL; monocytes (*10^3 c/uL): if value >2000/mm^3; basophils (*10^3 c/uL): if value >400/mm^3; eosinophils (*10^3 c/uL): if value> 0.750*10^3 c/uL|Days 15 to 56 days post last dose of the long-term period|All participants who received at least 1 dose of study medication.||Participants|||Number
768603|NCT00705367|Primary|Short-term Period: Number of Participants With Clinical Laboratory and Electrocardiogram (ECG) Abnormalities|Laboratory tests consisted of complete blood count, chemistry, and urinalysis.|Screening and Days 1 and 2|All participants who received at least 1 dose of study drug||Participants|||Number
768604|NCT00705367|Primary|Short-term Period: Mean Temperature|Vital sign measurements are summarized without regard to position (sitting, standing, supine).|Day 1 predose and postdose and Day 2|All participants who received at least 1 dose of study medication.||Degrees Celsius||Standard Deviation|Mean
768605|NCT00705367|Secondary|Maximum (Cmax) Plasma Concentration of Abatacept|Cmax is a drug's maximum, or peak, concentration observed after its administration.|Postdosing Day 1|All participants who received at least 1 dose of study drug and had a serum concentration measurement relative to dosing time. n=number of evaluable participants.||ug/mL||Geometric Coefficient of Variation|Geometric Mean
768606|NCT00705367|Primary|Short-term Period: Mean Respirations Rate|Vital sign measurements are summarized without regard to position (sitting, standing, supine).|Day 1 predose and postdose and Day 2|All participants who received at least 1 dose of study medication.||Respirations per minute||Standard Deviation|Mean
768607|NCT00705367|Primary|Short-term Period: Mean Heart Rate|Vital signs measurements are summarized without regard to position (sitting, standing, supine).|Day 1 predose and postdose and Day 2|All participants who received at least 1 dose of study medication.||beats per minute||Standard Deviation|Mean
768608|NCT00705367|Primary|Short-term Period: MeanSystolic and Diastolic Blood Pressure|Vital sign measurements are summarized without regard to position (sitting, standing, supine).|Day 1 predose and postdose and Day 2|All participants who received at least 1 dose of study medication.||mm Hg||Standard Deviation|Mean
768609|NCT00705367|Primary|Short-term Period: Number of Adverse Events (AEs) Related to Study Drug|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. Intensity = mild (grade 1), moderate (grade 2), severe (grade 3), life-threatening/disabling (grade 4).|From Day 1 of double-blind period to 1st dose of long-term period|All participants who received at least 1 dose of study medication.||Events|||Number
768610|NCT00705367|Secondary|Minimum (Cmin) Plasma Concentration of Abatacept|Cmin is the minimum, or trough, concentration of a drug observed after its administration and just prior to the administration of a subsequent dose.|Days 15, 29, 85, 169, 253 and 337|All participants who received at least 1 dose of study drug and had a serum concentration measurement relative to dosing time. n=number of evaluable participants.||ug/mL||Standard Deviation|Mean
768611|NCT00705367|Secondary|Long-term Period: Number of Participants With Death as Outcome, Serious AEs (SAEs), Discontinuations Due to AEs, and Treatment-related AEs|AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|Days 15 to 56 days post last dose of the long-term period|All participants who received at least 1 infusion of abatacept during the open-label long-term extension period of the study.||Participants|||Number
768612|NCT00705367|Primary|Short-term Period: Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, Discontinuations and Infusional AEs|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|From Day 1 of double-blind period to 1st dose of long-term period|All participants who received at least 1 dose of study medication.||Participants|||Number
768613|NCT00705406|Other Pre-specified|Change in Influenza Virus B Susceptibility to Neuraminidase Inhibitors (Mean Baseline IC50 and Fold Change From Baseline in IC50)|Change from Baseline to last positive value of influenza virus susceptibility to neuraminidase inhibitors was assessed using virology laboratory tests. Virology laboratory tests included phenotypic characterizations of influenza virus recovered (hemagglutinin and neuraminidase) and viral susceptibility to zanamivir, oseltamivir, and peramivir, as well as genotyping of virus isolates. These analyses were presented separately by treatment group and viral subtype. Baseline was defined as the last non-missing value occuring prior to the initiation of study drug.|Baseline and up to 14 days|A subgroup of the Intent-to-Treat Infected (ITTI) population that included all subjects who were randomized, received study drug, and had confirmed influenza B infection by culture or PCR. The n reported is the number for fold change (participants who had baseline and last positive susceptibility values to zanamivir, oseltamivir, and peramivir).||Fold Change from Baseline||Standard Error|Mean
768628|NCT00698685|Primary|Non-relapse Mortality at or Before Day 100|The primary safety outcome is indicated by the number of participants who died at or before Day 100 after transplant for any reason other than relapse of disease (Leukemia, Lymphoma, Hodgkin’s disease, Hematologic Neoplasms, Multiple Myeloma, Renal Cell Carcinoma).|Day 100 after transplant|All participants who received at least 1 day of treatment.||Participants|||Number
768614|NCT00705406|Other Pre-specified|Baseline Influenza Virus B Susceptibility to Neuraminidase Inhibitors (Mean Baseline IC50)|Baseline value of influenza virus susceptibility to neuraminidase inhibitors was assessed using virology laboratory tests. Virology laboratory tests included phenotypic characterizations of influenza virus recovered (hemagglutinin and neuraminidase) and viral susceptibility to zanamivir, oseltamivir, and peramivir, as well as genotyping of virus isolates. Baseline was defined as the last non-missing value occuring prior to the initiation of study drug.|Baseline and up to 14 days|A subgroup of the Intent-to-Treat Infected (ITTI) population that included all subjects who were randomized, received study drug, and had confirmed influenza B infection by culture or PCR. The n reported is the number of participants who had baseline susceptibility values to zanamivir, oseltamivir, and peramivir.||nM||Standard Error|Mean
768615|NCT00705406|Other Pre-specified|Change in Influenza Virus A (H1N1) Susceptibility to Neuraminidase Inhibitors (Fold Change From Baseline in IC50)|Change from Baseline to last positive value of influenza virus susceptibility to neuraminidase inhibitors was assessed using virology laboratory tests. Virology laboratory tests included phenotypic characterizations of influenza virus recovered (hemagglutinin and neuraminidase) and viral susceptibility to zanamivir, oseltamivir, and peramivir, as well as genotyping of virus isolates. These analyses were presented separately by treatment group and viral subtype.|Baseline and up to 14 days|A subgroup of the Intent-to-Treat Infected Influenza A (ITTI-A) population that included all subjects who were randomized, received study drug, and had confirmed influenza A (H1N1) infection by culture or PCR. N is for fold change (participants who had baseline and last positive susceptibility values to zanamivir, oseltamivir, and peramivir).||Fold Change from Baseline||Standard Error|Mean
768616|NCT00705406|Other Pre-specified|Baseline Influenza Virus A (H1N1) Susceptibility to Neuraminidase Inhibitors (Mean IC50)|Baseline value of influenza virus susceptibility to neuraminidase inhibitors was assessed using virology laboratory tests. Virology laboratory tests included phenotypic characterizations of influenza virus recovered (hemagglutinin and neuraminidase) and viral susceptibility to zanamivir, oseltamivir, and peramivir, as well as genotyping of virus isolates.|Baseline|A subgroup of the Intent-to-Treat Infected Influenza A (ITTI-A) population that included all subjects who were randomized, received study drug, and had confirmed influenza A (H1N1) infection by culture or PCR. N was 113 for zanamivir susceptibility in the Placebo group.||nM||Standard Error|Mean
768617|NCT00705406|Other Pre-specified|Incidence of Influenza-related Complications|Study personnel were provided with an IRC checklist in the CRF to evaluate the subject for the presence of clinical signs and/or symptoms of the following IRCs: sinusitis, otitis, bronchitis, and pneumonia. Subjects with clinical signs and/or symptoms consistent with these conditions at Screening were not eligible for enrollment in this study.|14 days|The Intent-to-Treat Infected Influenza A (ITTI-A) population included all subjects who were randomized, received study drug, and had confirmed influenza A infection by culture or PCR.||participants|||Number
768618|NCT00705406|Other Pre-specified|Time to Resolution of Fever|Time to resolution of fever was defined as the number of hours from initiation of study drug until temperature was less than 37.2 °C (99.0 °F) and no antipyretic medication had been taken for at least 12 hours.|Information collected twice daily beginning predose on Day 1 and through Day 9, then once daily through Day 14|The Intent-to-Treat Infected Influenza A (ITTI-A) population included all subjects who were randomized, received study drug, and had confirmed influenza A infection by culture or PCR.||hours||95% Confidence Interval|Median
768619|NCT00705406|Other Pre-specified|Subject’s Severity of Illness (Score*Hours)|"A subject’s severity of illness (area under the symptom score curve, as measured in score-hours) was assessed using available symptom score data until the time of alleviation of symptoms.The score-hours were calculated as the product of the daily symptom score times the hours to alleviation. All available data until time of alleviation were utilized.
The daily symptom score was defined as the sum of the 7 symptoms of influenza recorded by the subject in the diary each day (cough; sore throat; nasal congestion; myalgia [aches and pains]; headache; feverishness; and fatigue), each graded on a 4-point severity scale [0, absent; 1, mild; 2, moderate; 3, severe]); for the composite score, individual scores were summed, with a range from 0 to 21."|Information collected predose on Day 1 and then once daily through Day 14|The Intent-to-Treat Infected Influenza A (ITTI-A) population included all subjects who were randomized, received study drug, and had confirmed influenza A infection by culture or PCR.||score*hours||Full Range|Median
768620|NCT00705406|Secondary|Change in Influenza Virus Shedding|Changes from Baseline in log10 TCID50/mL through Days 3, 4, and 9 were presented by treatment group for subjects with positive viral titers at Baseline (log10 TCID50/mL >0.5).|Baseline and Days 3, 4, 9|The Intent-to-Treat Infected Influenza A (ITTI-A) population included all subjects who were randomized, received study drug, and had confirmed influenza A infection by culture or PCR.||log10(TCID50/mL)||95% Confidence Interval|Median
768621|NCT00705406|Primary|Time to Alleviation of Symptoms (Kaplan-Meier Estimate)|The primary efficacy endpoint was the time to alleviation of symptoms calculated as the number of hours from initiation of study drug until the start of the time period in which all 7 symptoms of influenza were either absent or present at a level no greater than mild for at least 21.5 (24 hours - 10%) hours. Subjects with missing diary data were excluded and those who did not experience alleviation of symptoms were censored at the last observed symptom assessment.|Information collected twice daily beginning predose on Day 1 and through Day 9, then once daily through Day 14|The Intent-to-Treat Infected with Influenza A (ITTI-A) population included all subjects who were randomized, received study drug, and had confirmed influenza A by culture or PCR.||hours||95% Confidence Interval|Median
768622|NCT00698646|Secondary|Time in Weeks to Achieving the First Treatment Success (Defined as the Time of the First Achievement of the Target Blood Pressure Goal [MSSBP/MSDBP <140/90 mmHg])||During 16 weeks|Intent to treat (ITT)||Weeks||95% Confidence Interval|Median
768623|NCT00698646|Secondary|Cumulative Percentage of Patients Achieving Blood Pressure Goal (MSSBP < 140 mmHg)|Cumulative refers to achieving blood pressure goal before or at the corresponding visit.|Weeks 4, 8, 12 and 16|Intent to treat (ITT)||Percentage of Participants|||Number
768624|NCT00698646|Secondary|Cumulative Percentage of Patients Achieving the Blood Pressure Control of < 140/90 mmHg|Cumulative refers to achieving of blood pressure control before or at the corresponding visit.|Weeks 4, 8, 12 and 16|Intent to treat (ITT)||Percentage of Participants|||Number
768625|NCT00698646|Secondary|Change From Baseline to Weeks 8, 12 and 16 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)||Baseline and Weeks 8, 12, and 16|Intent to treat (ITT), Last observation carried forward||mm Hg||Standard Deviation|Mean
768629|NCT00698685|Primary|Actuarial Probability of Donor Hematopoietic Engraftment (Defined as at Least 50% Donor DNA in Bone Marrow at Day 100).|The number of participants with donor hematopoietic engraftment at day 100 is reported in the data table, and the actuarial probability is calculated using the Kaplan-Meier product-limit estimate statistic, as reported in the statistical analysis section below.|Day 100 after transplant.|All participants who completed treatment and underwent allogeneic transplant.||participants|||Number
768630|NCT00698815|Secondary|Overall Survival (OS)|OS is defined as the time from patient randomization to death from any cause. The median OS with 95% CI was estimated using the Kaplan-Meier method.|Time from randomization to death (up to 3 years)|||months||95% Confidence Interval|Median
768631|NCT00698815|Secondary|Overall Response Rate|"The proportion of patients who respond (completely or partially) to each combination regimen will be estimated. An exact binomial confidence interval will be computed for these estimates.
Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions."|Duration of treatment (up to 3 years)|||percentage of participants||95% Confidence Interval|Number
768632|NCT00698815|Secondary|PFS|PFS was defined as the time from randomization until disease progression or death, whichever occurs first. The median PFS with 95% CI was estimated using the Kaplan-Meier method. Progression is defined as in the primary outcome measure.|Time from randomization to disease progression and death of any cause, whichever comes first (up to 3 years)|||months||95% Confidence Interval|Median
768633|NCT00698815|Primary|18 Week Progression-free Survival (PFS) Rate|The 18 week progression-free survival rate was defined as the proportion of patients that were alive and progression-free 18 weeks after registration into the study. Disease progression was assessed per modified RECIST criteria, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, in either primary or nodal lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of new lesions. Kaplan-Meier estimate of 18-week progression-free survival was calculated.|At 18 weeks|||percentage of participants||95% Confidence Interval|Number
768634|NCT00698841|Secondary|Number of Participants With Hematology Abnormalities by Worst CTC Grade at Baseline and On-study|BL=baseline; OS=on-study; LLN=lower level of normal. Laboratory values assessed using CTC for AEs, Version 3.0. Hemoglobin (g/dL) Grade 1:<LLN to 10.0, Grade 2:<10.0 to 8.0, Grade 3:<8.0 to 6.5, Grade 4:<6.5. Platelets Grade 1:LLN to 75.0*10^9/L, Grade 2:<75.0 to 50.0*10^9/L, Grade 3:<50.0 to 25.0*10^9/L, Grade 4:<25.0 to 10^9/L. White blood cells Grade 1:<LLN to 3.0*10^9/L, Grade 2:<3.0 to 2.0*10^9/L, Grade 3:<2.0 to 1.0*10^9/L, Grade 4:<1.0*10^9/L. Neutrophils Grade 1:<LLN to 1.5*10^9/L, Grade 2:<1.5 to 1.0*10^9/L, Grade 3:<1.0 to 0.5*10^9/L, Grade 4:<0.5*10^9/L.|At screening, weekly prior to start of cetuximab infusion, at end of Cycle 1 (28 days), and at 30-day follow-up|All participants who received at least 1 dose of cetuximab.||Participants|||Number
768635|NCT00698841|Primary|Mean Change in QTc From Time-matched Baseline Assessed Using Fridericia’s Correction Formula (QTcF) by Study Day and Time Point|The QT interval is the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. The QTc is the QT interval corrected for heart rate. The QTcF=QT/RR^1/3, where RR=RR interval in seconds. Baseline=predose. Mean change in QTc interval from baseline to time t=QTc interval at time t minus QTc interval at baseline.|Predose Day 1 (Baseline) to end of Cycle 1 (28 days)|Those who met all study criteria and did not require interrupted cetuximab infusion on Day (D)1 or 22; miss an ECG timepoint at baseline, D1, or D22; stop/modify dose of a scheduled drug that prolongs QT/QTc interval, receive other cancer therapy, begin a prohibited drug, or require cetuximab dose reduction before D29; withdraw consent before D23.||msec||Standard Error|Mean
768636|NCT00698841|Secondary|Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study (Continued)|BL=baseline; OS=on-study; LLN=lower level of normal; ULN=upper level of normal. Sodium, low(mmol/L) Grades 1&2:<LLN–130, Grade 3:<130–120, Grade 4:<120. Sodium, high (mmol/L) Grade 1:>ULN-150, Grade 2:>150-155, Grade 3:>155-160, Grade 4:>160. Potassium, high (mmol/L) Grade 1:>ULN-5.5, Grade 2:>5.5-6.0, Grade 3:>6.0-7.0, Grade 4:>7.0. Glucose, low(mg/dL) Grade 1:<LLN-55, Grade 2:<55-40, Grade 3:<40-30, Grade 4:<30. Glucose, high (mg/dL) Grade 1:>ULN-160, Grade 2:>160-250, Grade 3:>250-500, Grade 4:>500. Calcium, high(mg/dL) Grade 1:>ULN-11.5, Grade 2:>11.5-12.5, Grade 3:>12.5-13.5, Grade 4:>13.|At screening, at the end of Cycle 1 (28 days)|All participants who received at least 1 dose of cetuximab||Participants|||Number
768637|NCT00698841|Secondary|Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study|BL=baseline; OS=on-study; ULN=upper level of normal. Albumin,low (g/dL) Grade 1:<LLN-30, Grade 2:<30-20, Grades 3&4:<20. Aspartate aminotransferase (AST)(U/L) Grade 1:>ULN-2.5*ULN, Grade 2:>2.5-5.0*ULN, Grade 3:>5.0-20.0*ULN, Grade 4:>20.0*ULN. Total bilirubin, high Grade 1:ULN-1.5*ULN, Grade 2:>1.5-3.0*ULN, Grade 3:>3.0-10.0*ULN, Grade 4:>10.0*ULN. Alkaline phosphatase (ALP) (U/L) Grade 1:>ULN-2.5*ULN, Grade 2:>2.5-5.0*ULN, Grade 3:>5.0-20.0*ULN, Grade 4:>20.0*ULN. Creatinine (mg/dL) Grade 1:>ULN-1.5*ULN, Grade 2:>1.5-3.0*ULN, Grade 3:>3.0-6.0*ULN, Grade 4:>6.0*ULN.|At screening, at the end of Cycle 1 (28 days)|All participants who received at least 1 dose of cetuximab||Participants|||Number
768638|NCT00698841|Secondary|Number of Participants With AEs of Special Interest by Worst Common Terminology Criteria (CTC) Grade|AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with treatment. AEs of special interest have been sponsor-selected based on the known clinical effects of cetuximab. Treatment related=possibly, probably, or certainly related to or of unknown relationship to study treatment. CTC Grade 1: Mild. Grade 2: Moderate. Grade 3: Severe or medically significant but not immediately life-threatening. Grade 4: Life-threatening.|Baseline through Cycle 1 (28 days), continuously|||Participants|||Number
768639|NCT00698841|Secondary|Number of Participants With Death, Treatment-related Death, Serious Adverse Events (SAEs), Treatment-related SAEs, Adverse Events (AEs) Leading to Discontinuation, and Treatment-related AEs Leading to Discontinuation|AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with treatment. SAE=any untoward medical occurrence that at any dose results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, or is an important medical event. Treatment related=possibly, probably, or certainly related to or of unknown relationship to study treatment.|Baseline through Cycle 1 (28 days), continuously|All participants who received at least 1 dose of cetuximab.||Participants|||Number
768640|NCT00698841|Secondary|Number of Participants With Clinically Significant Changes in PR Interval, QRS Interval, and Heart Rate|12-Lead continuous digital ECG data were collected at preselected time points at baseline visit and on Days 1, 8, 15, 22, and 29. The PR interval is the time from the onset of the P wave to the beginning of the QRS complex. The QRS interval=deflections in the ECG, comprising Q, R, and S waves, that represent depolarization of the ventricles. Clinically significant was determined at the investigator's discretion.|Baseline, Day 1, and then weekly to end of Cycle 1 (28 days)|Those who met all study criteria and did not require interrupted cetuximab infusion on Day (D)1 or 22; miss an ECG timepoint at baseline, D1, or D22; stop/modify dose of a scheduled drug that prolongs QT/QTc interval, receive other cancer therapy, begin a prohibited drug, or require cetuximab dose reduction before D29; withdraw consent before D23.||Participants|||Number
768641|NCT00698841|Primary|Number of Participants With Clinically Meaningful Prolongation of the QT Interval Corrected for Heart Rate (QTc) From Time-matched Baseline|12-Lead continuous digital electrocardiogram (ECG) data were collected at preselected time points at baseline visit and on Days 1, 8, 15, 22, and 29. The QT interval is the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. The corrected QTc is the QT interval corrected for heart rate. Prolongation of the QTc was identified as clinically meaningful at the investigator's discretion.|Baseline, Day 1, and then weekly to end of Cycle 1 (28 days)|Those who met all study criteria and did not require interrupted cetuximab infusion on Day (D)1 or 22; miss an ECG timepoint at baseline, D1, or D22; stop/modify dose of a scheduled drug that prolongs QT/QTc interval, receive other cancer therapy, begin a prohibited drug, or require cetuximab dose reduction before D29; withdraw consent before D23.||Participants|||Number
768642|NCT00698867|Secondary|Incidence of Surviving Elbows|Proportion of elbows that did not require revision or removal|Up to 5 Years|Subjects with complete 5 year data.||Proportion of Elbows|Elbows|95% Confidence Interval|Number
768643|NCT00698867|Primary|Surgeon Derived American Shoulder and Elbow Society Score (ASES) Strength|Measure of elbow strength as defined by the investigator. Maximum score is 20 and the minimum is 0. The maximum score indicates maximum strength.|5 Years|||Scores on a scale|Elbows|Standard Deviation|Mean
768644|NCT00698867|Primary|Surgeon Derived American Shoulder and Elbow Society Score (ASES) Stability|Surgeon assessment of patient elbow stability. Maximum instability score is 9 and the minimum is 0. The maximum score indicates the least stability.|5 Years|||Scores on a scale|Elbows|Standard Deviation|Mean
768645|NCT00698867|Primary|Surgeon Derived American Shoulder and Elbow Society Score (ASES) Signs|This is a measure of the elbow signs as reported by the investigator. Signs include various assessments of joint tenderness, impingement, and pain in range of motion. The maximum score is 39 and the minimum is 0. The maximum score indicates the most abnormal signs.|5 Years|||Scores on a scale|Elbows|Standard Deviation|Mean
768646|NCT00698867|Primary|Patient Derived American Shoulder and Elbow Society Score (ASES) Satisfaction|This is a measure of patient satisfaction as answered by the patient. The maximum score is 10 and the minimum is 0. The maximum score indicates maximum satisfaction.|5 Years|||Scores on a scale|Elbows|Standard Deviation|Mean
768647|NCT00698867|Primary|Patient Derived American Shoulder and Elbow Society Score (ASES) Function|This is a measure of patient function as answered by the patient. The maximum score is 36 and the minimum is 0. The maximum score represents maximum function.|5 Years|Discovery elbows||Scores on a scale|Elbows|Standard Deviation|Mean
768648|NCT00698867|Primary|American Shoulder and Elbow Society Score (ASES) Pain Assessment|This is a patient reported outcome measure that indicates the patient's pain as measured on the ASES form. The maximum pain score is 50 and the minimum score is 0. A higher pain score indicates the subject is in more pain. A lower pain score indicates less pain.|5 years|Discovery Elbow||Scores on a scale|Elbows|Standard Deviation|Mean
768649|NCT00698932|Secondary|Proportion of Patients Achieving a Therapeutic Glycemic Response Defined as HbA1c <7.0% at Week 24|Proportion of participants (expressed in percentage of total participants) achieving HbA1c < 7.0% for saxagliptin versus placebo at week 24. HbA1c Data were excluded on and after rescue medication|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Wk 24 LOCF for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. If participant received rescue medication, that measurement must have been taken before rescue.||Percentage of Participants|||Number
768650|NCT00698932|Secondary|Absolute Change (mg*Min/dL) From Baseline to Week 24 in Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During Mixed Meal (Instant Noodles) Tolerance Tests (MMTT) in All MMTT Participants|Adjusted* mean change from baseline in PPG AUC achieved with saxagliptin 5 mg versus placebo at week 24 (LOCF, Full Analysis set). Trapezoidal method was used to compute AUC under the 3 hour PPG curve. Change from baseline for each subject is computed as the week 24 value minus the baseline value.PPG data were excluded on and after rescue medication|Baseline , Week 24|MMTT was measured on a subset of patients in China cohort only at baseline and Wk 24. Randomized subjects, who took at least 1 dose of double-blind treatment to be included in analysis: change from baseline to Wk 24 (LOCF), must have had baseline and post-baseline data. Measurements observed on and after rescue medication were excluded.||mg*min/dL||Standard Error|Mean
768651|NCT00698932|Secondary|Absolute Change (mmol*Min/L) From Baseline to Week 24 in Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During Mixed Meal (Instant Noodles) Tolerance Tests (MMTT) in All MMTT Participants|Adjusted* mean change from baseline in PPG AUC achieved with saxagliptin 5 mg versus placebo at week 24 (LOCF, Full Analysis set). Trapezoidal method was used to compute AUC under the 3 hour PPG curve. Change from baseline for each subject is computed as the week 24 value minus the baseline value.PPG data were excluded on and after rescue medication|Baseline , Week 24|MMTT was measured on a subset of patients in China cohort only at baseline and Wk 24. Randomized subjects, who took at least 1 dose of double-blind treatment to be included in analysis: change from baseline to Wk 24 (LOCF), must have had baseline and post-baseline data. Measurements observed on and after rescue medication were excluded.||mmol*min/L||Standard Error|Mean
768663|NCT00699140|Primary|Responder Patients|The primary efficacy endpoint was the proportion of patients who reached a platelet count ≥ 50x10^9/L.|At any time during the study period (The platelet count was measured at Days 1-6, 10, 14. 21, 30, 60, 90).|All 18 subjects received at least one infusion (at any dose) of IGIV3I Grifols and were included in the intent-to-treat (ITT) population for efficacy and safety analysis.||percentage of subjects||95% Confidence Interval|Number
768652|NCT00698932|Secondary|Absolute Change (mg/dL) From Baseline to Week 24 in Fasting Plasma Glucose (FPG)|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg versus placebo at week 24 (LOCF, Full Analysis set). FPG is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. FPG data were excluded on and after rescue medication.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Wk 24 LOCF for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. If participant received rescue medication, that measurement must have been taken before rescue.||mg/dL||Standard Error|Mean
768653|NCT00698932|Secondary|Absolute Change (mmol/L) From Baseline to Week 24 in Fasting Plasma Glucose (FPG)|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg versus placebo at week 24 (Last Observation Carried Forward (LOCF), Full Analysis set). FPG is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. FPG data were excluded on and after rescue medication.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Wk 24 LOCF for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. If participant received rescue medication, that measurement must have been taken before rescue.||mmol/L||Standard Error|Mean
768654|NCT00698932|Primary|Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c)|Adjusted* mean change from baseline in HbA1c achieved with saxagliptin 5 mg versus placebo at week 24 (LOCF, Full Analysis set). HbA1c is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. HbA1c data were excluded on and after rescue medication.|Baseline , Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Wk 24 LOCF for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. If participant received rescue medication, that measurement must have been taken before rescue.||percent||Standard Error|Mean
768655|NCT00699140|Secondary|Viral Safety Through the Investigation of Patients Virology Status (Hepatitis A Virus [HA|The results of HIV-1 and -2 antibodies, HCV antibody, HBsAg, HBV antibodies, HAV antibodies, HIV nucleic acid amplification test [NAT], and HCV NAT on Day 1, Day 14, and at Month 1, Month 2 and Month 3 were recorded for several of these markers (as appropriate). A comparison of negative viral markers on Day 1 and Month 3 was performed|At any time during the study period (from patient's signature of the informed consent form until 3 months of follow-up)|Intent-to-treat population||seroconversions|||Number
768656|NCT00699140|Secondary|Changes in Vital Signs and Clinically Relevant Changes in Laboratory Parameters After the Infusions, Including Renal Function (Creatinine Levels)|Laboratory parameters at each treatment day and visit are summarized by patient. Results were marked as normal/abnormal (whether the result is below, within or above the respective reference range) and relevant/irrelevant (as determined by the investigator). The number of abnormal values considered clinically relevant changes (based on the investigator’s judgment) was listed.|At any time during the study period (from patient's signature of the informed consent form until 3 months of follow-up)|Intent-to-treat population||participants|||Number
768657|NCT00699140|Secondary|Frequency of Adverse Reactions During and After Infusions by Percentage of Infusions|All adverse events (AEs) are tabulated and summarized. The incidence, severity, and causal relationship of the AEs to IGIV3I Grifols are presented by system organ class after medical coding according to the version 15.0 of Medical Dictionary for Regulatory Activities (MedDRA). The frequency of infusions associated with at least one AE and adverse drug reactions are estimated.|At any time during the study period (from patient's signature of the informed consent form until 3 months of follow-up)|ITT population: patient who received at least one infusion with the study drug.||percentage of infusions|||Number
768658|NCT00699140|Secondary|Frequency of Adverse Reactions During and After Infusions by Percentage of Patients|All adverse events (AEs) are tabulated and summarized. The incidence, severity, and causal relationship of the AEs to IGIV3I Grifols are presented by system organ class after medical coding according to the version 15.0 of Medical Dictionary for Regulatory Activities (MedDRA). The frequency of patients with at least one AE and adverse drug reactions are estimated.|At any time during the study period (from patient's signature of the informed consent form until 3 months of follow-up)|ITT population: patient who received one infusion with the study drug.||percentage of patients|||Number
768659|NCT00699140|Secondary|Regression of Hemorrhages.|"Percentage of subjects with regression of hemorrhages of Types 1 to 3:
Type 0: Patients without symptoms of bleeding at the first infusion continue without presenting spontaneous bleeding
Type 1: Patients with bleeding symptoms at the first infusion had a reduction of the size of large ecchymoses, and no spontaneous appearance of new ecchymoses
Type 2: Patients with bleeding symptoms at the first infusion had a decrease in the number of cutaneous petechiae, or the extent of the affected area of the body decreased
Type 3: Patients had active mucosal bleedings at the first infusion, these episodes stopped without re-bleeding, and there was no occurrence of new spontaneous mucosal hemorrhages (e.g., gingival bleeding, epistaxis)"|First 10 to14 days since the first infusion day (Day 1)|ITT population: patients who received at least one infusion of the study drug||percentage of subjects||95% Confidence Interval|Number
768660|NCT00699140|Secondary|Length of Time Platelet Count Remains ≥ 50x10^9/L (≥ Days)|Length of time platelet count remained ≥ 50x10^9/L from first dose (Day 1)|At any time during the study period (up to 3 months [90 days])|From all 18 subjects who received at least one infusion and were included in the intent-to-treat (ITT) population only 13 responded to the treatment||days||Full Range|Median
768661|NCT00699140|Secondary|Time to Reach Platelet Count ≥ 50x10^9/L (≤ Days)|The time taken for the platelet count to reach ≥ 50x10^9/L from first dose|At any time during the study period (time points: Days 1-6, 10, 14, 21, 30, 60, 90 post-first infusion day [Day 1])|From all 18 subjects who received at least one infusion and were included in the intent-to-treat (ITT) population but only 13 responded to the treatment||days||Full Range|Median
768662|NCT00699140|Secondary|Maximum Platelet Level Reached During the Follow-up Period|Platelet count was measured at various time points in the follow-up period after infusion.|During the follow-up period (time points: Days 6, 10, 14, 21, 30, 60, 90 post-first infusion day [Day 1])|The maximum platelet counts were taken from the population who responded to treatment (platelet count ≥ 50x10^9/L). If any patient received banned medication due to ITP progression during the study, the values obtained after patients received treatment were excluded.||platelets x 10^-9/L||Full Range|Median
768664|NCT00699153|Secondary|Mean Change From Baseline to Each Follow-up Visit in Anterior Chamber Cells and Flare|A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= >30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe.|Postoperative Day 3-18 (Each follow-up Visit 4-7)|Intent to treat population.||Composite scores||Standard Deviation|Mean
768665|NCT00699153|Secondary|Participants With Complete Resolution of Anterior Chamber Cells and Flare, at Each Visit.|A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= >30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe.|At each visit: Visit 4-7, postoperative days 3-18|Intent to treat population||participants|||Number
768666|NCT00699153|Primary|Participants With Grade 0 (no) Pain|Pain: A positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching. Grade 0 = None; 1=Minimal; 2=Mild; 3=Moderate; 4=Moderately Severe; 5=Severe|Postoperative day 8 (Visit 5)|Intent to treat population||participants|||Number
768667|NCT00699153|Primary|Participants With Complete Resolution of Anterior Chamber Cells and Flare. Grade=0|A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= >30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe.|Postoperative day 8 (Visit 5)|Intent to treat population, subjects who had missing data or took rescue medication prior to visit 5 were imputed as no.||participants|||Number
768668|NCT00699192|Secondary|Percentage of Patients Achieving Overall Blood Pressure Control at the End of the Study (Week 8)|Overall blood pressure control was defined as a msSBP < 140 mmHg and msDBP < 90 mmHg at the end of the study (Week 8). At study entry, blood pressure (BP) was measured in both arms with an automatic BP monitor. The arm with the higher systolic BP reading was used for all measurements throughout the study. At each study visit, 3 separate sitting BPs were obtained 23-26 hours post-dose with at least 2 minutes between measurements and with the cuff fully deflated. Mean BP was automatically calculated from the 3 readings.|End of study (Week 8)|The Full Analysis Set (FAS) population: All randomized patients who had a baseline and at least one post-baseline assessment an efficacy variable. For the subjects who did not complete the week 8 assessments, an LOCF (last observation carried forward) approach was used.||Percentage of patients|||Number
768669|NCT00699192|Secondary|Percentage of Patients Achieving Systolic Blood Pressure Control at the End of the Study (Week 8)|Systolic blood pressure control was defined as a msSBP < 140 mmHg at the end of the study (Week 8). At study entry, blood pressure (BP) was measured in both arms with an automatic BP monitor. The arm with the higher systolic BP reading was used for all measurements throughout the study. At each study visit, 3 separate sitting BPs were obtained 23-26 hours post-dose with at least 2 minutes between measurements and with the cuff fully deflated. Mean BP was automatically calculated from the 3 readings.|End of study (Week 8)|The Full Analysis Set (FAS) population: All randomized patients who had a baseline and at least one post-baseline assessment an efficacy variable. For the subjects who did not complete the week 8 assessments, an LOCF (last observation carried forward) approach was used.||Percentage of patients|||Number
768670|NCT00699192|Secondary|Percentage of Patients Achieving a Systolic Blood Pressure Response at Week 8|A systolic blood pressure response was defined as a msSBP < 140 mmHg or ≥ 15 mmHg reduction from baseline at the end of the study (Week 8). At study entry, blood pressure (BP) was measured in both arms with an automatic BP monitor. The arm with the higher systolic BP reading was used for all measurements throughout the study. At each study visit, 3 separate sitting BPs were obtained 23-26 hours post-dose with at least 2 minutes between measurements and with the cuff fully deflated. Mean BP was automatically calculated from the 3 readings.|Baseline to end of study (Week 8)|The Full Analysis Set (FAS) population: All randomized patients who had a baseline and at least one post-baseline assessment an efficacy variable. For the subjects who did not complete the week 8 assessments, an LOCF (last observation carried forward) approach was used.||Percentage of patients|||Number
768671|NCT00699192|Secondary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8)|At study entry, blood pressure (BP) was measured in both arms with an automatic BP monitor. The arm with the higher systolic BP reading was used for all measurements throughout the study. At each study visit, 3 separate sitting BPs were obtained 23-26 hours post-dose with at least 2 minutes between measurements and with the cuff fully deflated. Mean BP was automatically calculated from the 3 readings. A negative change from baseline indicates lowered BP.|Baseline to end of study (Week 8)|The Full Analysis Set (FAS) population: All randomized patients who had a baseline and at least one post-baseline assessment an efficacy variable. For the subjects who did not complete the week 8 assessments, an LOCF (last observation carried forward) approach was used.||mmHg||Standard Deviation|Mean
768672|NCT00699192|Primary|Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8)|At study entry, blood pressure (BP) was measured in both arms with an automatic BP monitor. The arm with the higher systolic BP reading was used for all measurements throughout the study. At each study visit, 3 separate sitting BPs were obtained 23-26 hours post-dose with at least 2 minutes between measurements and with the cuff fully deflated. Mean BP was automatically calculated from the 3 readings. A negative change from baseline indicates lowered BP.|Baseline to end of study (Week 8)|The Full Analysis Set (FAS) population: All randomized patients who had a baseline and at least one post-baseline assessment an efficacy variable. For the subjects who did not complete the Week 8 assessments, an LOCF (last observation carried forward) approach was used.||mmHg||Standard Deviation|Mean
768688|NCT00699335|Primary|EQ-5D (Optional): Domain Mobility|"This outcome measure to assess patients quality of life is based on an optional standardised patient questionnaire (EQ-5D).
Questions on a scale from 1-3 at initial and final visit:
I have no problems in walking around
I have some problems in walking around
I am confined to bed"|Before and after therapy with Matrifen® (4 weeks)|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat||Units on a scale||Standard Deviation|Mean
769571|NCT00705939|Primary|Spleen Volume|Spleen volume measured by MRI|Spleen Volume at Baseline and Months 12, 24, and 36|Intent to treat. In the Switchover group, two patients did not have MRI and one patient was splenectomized.||mL||Standard Deviation|Mean
768673|NCT00699283|Primary|The Cumulative Exit Rate at 112 Days After the Beginning of the Baseline Antiepileptic Drug (AED) Tapering Phase|The cumulative exit rate was estimated using Kaplan-Meier methods and was based on the duration between start of the Evaluation Period (EP) and the earliest date the first exit criterion was met for each subject. Subjects completing the EP without meeting an exit criterion were censored on Day 112. The primary comparison was BRV 50 mg/day vs a historical control. The upper limit of the 2-sided 95 % Confidence Interval for the estimate was compared to the historical lower bound estimate of 0.722.|From Visit 4 (week 1) to the end of the Evaluation Period (week 17) (approximately 16 weeks)|"The Efficacy Analysis Set (EFF) consisted of all randomized subjects with at least 1 intake of study medication who also entered into the Baseline antiepileptic drug (AED) Tapering Phase (during the Evaluation Period) and started with the withdrawal of Baseline AEDs.
The Outcome Measure was only pre-specified for the Brivaracetam (BRV) 50 mg Arm"||percentage of subjects||95% Confidence Interval|Number
768674|NCT00699335|Secondary|Physician's Final Assessment of the Tolerability of Matrifen®|Assessment on a scale: Excellent, good, satisfactory, dissatisfactory|After 4 week therapy with Matrifen®|All patients included and treated, intention to treat, missing values not imputed||Participants|||Number
768675|NCT00699335|Secondary|Physician's Assessment of the Adhesion Properties of the Fentanyl-patches|Assessment on a scale: Excellent, good, satisfactory, dissatisfactory|After 4 week therapy with Matrifen®|All patients included and treated, intention to treat, missing values not imputed||Participants|||Number
768676|NCT00699335|Primary|EQ-5D (Optional): Visual Analogue Scale|Visual Analogue Scale (VAS) from 0 =worst imaginable health status, 100 =best imaginable health status|Before and after therapy with Matrifen® (4 weeks)|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat||Units on a scale||Standard Deviation|Mean
768677|NCT00699335|Primary|EQ-5D (Optional): European Index Score|Index derived from the five EQ-5D-items (= mobility, self care, usual activities, pain/discomfort, anxiety/depression) resulting in a value from -1= very ill to 1=full health|Before and after therapy with Matrifen® (4 weeks)|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat||Units on a scale||Standard Deviation|Mean
768678|NCT00699335|Primary|EQ-5D (Optional): Domain Anxiety / Depression|"This outcome measure to assess patients quality of life is based on an optional standardised patient questionnaire (EQ-5D).
Questions on a scale from 1-3 at initial and final visit:
I am not anxious or depressed
I am moderately anxious or depressed
I am extremely anxious or depressed"|Before and after therapy with Matrifen® (4 weeks)|||Units on a scale||Standard Deviation|Mean
768679|NCT00699335|Primary|EQ-5D (Optional): Domain Anxiety / Depression|"This outcome measure to assess patients quality of life is based on an optional standardised patient questionnaire (EQ-5D).
Questions on a scale from 1-3 at initial and final visit:
I am not anxious or depressed
I am moderately anxious or depressed
I am extremely anxious or depressed"|Before and after therapy with Matrifen® (4 weeks)|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat||Participants|||Number
768680|NCT00699335|Secondary|Patient's Assessment of the Acceptance of the Fentanyl-patches|Assessment on a scale: Excellent, good, satisfactory, dissatisfactory|After 4 week therapy with Matrifen®|All patients included and treated, intention to treat, missing values not imputed||Participants|||Number
768681|NCT00699335|Secondary|Physician's Assessment of the Skin Tolerability of the Fentanyl-patches|Assessment on a scale: Excellent, good, satisfactory, dissatisfactory|After 4 week therapy with Matrifen®|All patients included and treated, intention to treat, missing values not imputed||Participants|||Number
768682|NCT00699335|Primary|EQ-5D (Optional): Pain / Discomfort|"This outcome measure to assess patients quality of life is based on an optional standardised patient questionnaire (EQ-5D).
Questions on a scale from 1-3 at initial and final visit:
I have no pain or discomfort
I have moderate pain or discomfort
I have extreme pain or discomfort"|Before and after therapy with Matrifen® (4 weeks)|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat||Units on a scale||Standard Deviation|Mean
768683|NCT00699335|Primary|EQ-5D (Optional): Pain / Discomfort|"This outcome measure to assess patients quality of life is based on an optional standardised patient questionnaire (EQ-5D).
Questions on a scale from 1-3 at initial and final visit:
I have no pain or discomfort
I have moderate pain or discomfort
I have extreme pain or discomfort"|Before and after therapy with Matrifen® (4 weeks)|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat||Participants|||Number
768684|NCT00699335|Primary|EQ-5D (Optional): Domain Usual Activities|"This outcome measure to assess patients quality of life is based on an optional standardised patient questionnaire (EQ-5D).
Questions on a scale from 1-3 at initial and final visit:
I have no problems with performing my usual activities
I have some problems with performing my usual activities
I am unable to perform my usual activities"|Before and after therapy with Matrifen® (4 weeks)|||Units on a scale||Standard Deviation|Mean
768685|NCT00699335|Primary|EQ-5D (Optional): Domain Usual Activities|"This outcome measure to assess patients quality of life is based on an optional standardised patient questionnaire (EQ-5D).
Questions on a scale from 1-3 at initial and final visit:
I have no problems with performing my usual activities
I have some problems with performing my usual activities
I am unable to perform my usual activities"|Before and after therapy with Matrifen® (4 weeks)|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat||Participants|||Number
768686|NCT00699335|Primary|EQ-5D (Optional): Domain Self Care|"This outcome measure to assess patients quality of life is based on an optional standardised patient questionnaire (EQ-5D).
Questions on a scale from 1-3 at initial and final visit:
I have no problems with self-care
I have some problems washing or dressing myself
I am unable to wash or dress myself"|Before and after therapy with Matrifen® (4 weeks)|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat||Units on a scale||Standard Deviation|Mean
768687|NCT00699335|Primary|EQ-5D (Optional): Domain Self Care|"This outcome measure to assess patients quality of life is based on an optional standardised patient questionnaire (EQ-5D).
Questions on a scale from 1-3 at initial and final visit:
I have no problems with self-care
I have some problems washing or dressing myself
I am unable to wash or dress myself"|Before and after therapy with Matrifen® (4 weeks)|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat||Participants|||Number
768689|NCT00699335|Primary|EQ-5D (Optional): Domain Mobility|"This outcome measure to assess patients quality of life is based on an optional standardised patient questionnaire (EQ-5D).
Questions on a scale from 1-3 at initial and final visit:
I have no problems in walking around
I have some problems in walking around
I am confined to bed"|Before and after therapy with Matrifen® (4 weeks)|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat||Participants|||Number
768690|NCT00699335|Primary|Physician's Final Assessment of the Efficacy of Therapy With Matrifen®|Assessment on a scale: Excellent, good, satisfactory, dissatisfactory|After 4 week therapy with Matrifen®|All patients included and treated, intention to treat, missing values not imputed||Participants|||Number
768691|NCT00699335|Primary|Patient's Assessment of Pain Severity Score|Assessment on a Visual Analogue Scale from 0=No pain to 10=Most severe pain|Before and after therapy with Matrifen® (4 weeks)|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat||Units on a scale||Standard Deviation|Mean
768692|NCT00699348|Secondary|Number of Participants With Red Blood Cell Transfusion During the Study|Number of participant who underwent red blood cell transfusion during the study was reported.|Week -4 up to Week 52|Safety population.||participants|||Number
768693|NCT00699348|Secondary|Percentage of Participants Requiring Any Dose Adjustment|Percentage of participants requiring any adjustment in the dose of study drug during the dose titration period (DTP: Week 1 to Week 16) and EEP (Week 17 to Week 24) was reported.|Week 1 up to Week 16 and Week 17 up to Week 24|PP population.||percentage of participants|||Number
768694|NCT00699348|Secondary|Median Time Spent by Participants With Hemoglobin Concentration in the Target Range During the EEP|Median time spent by participants with hemoglobin concentration within the target range of 10.0 to 12.0 g/dL during the EEP (Week 17 to Week 24) was assessed.|Week 17 up to Week 24|PP population.||days||Full Range|Median
768695|NCT00699348|Secondary|Percentage of Participants Maintaining Hemoglobin Concentration Within the Target Range|Percentage of participants maintaining hemoglobin concentration within the target range of 10.0 to 12.0 g/dL during EEP (Week 17 to Week 24) was assessed.|Week 17 up to Week 24|PP population.||percentage of participants||95% Confidence Interval|Number
768696|NCT00699348|Secondary|Change in Hemoglobin Concentration Between Reference SVP and EEP|The mean change of the time adjusted average of hemoglobin from reference value obtained during the SVP (Week -4 up to Week 0) and the value during EEP (Week 17 up to Week 24) was assessed.|Week -4 up to Week 0 and Week 17 up to Week 24|PP Population.||g/dL||Standard Deviation|Mean
768697|NCT00699348|Primary|Percentage of Participants Maintaining Mean Hemoglobin Concentration Within Plus or Minus (+/-) 1 Gram Per Deciliter (g/dL) of Reference and Within the Target Range|Percentage of participants maintaining the mean hemoglobin concentration within +/- 1.0 g/dL of their reference hemoglobin value and within the target range of 10.0 to 12.0 g/dL during the efficacy evaluation period (EEP) was assessed. The reference hemoglobin value was defined on the basis of the 5 assessments recorded during the stability verification period (SVP) at Weeks -4, -3, -2, -1 and 0. The mean hemoglobin concentration for each individual participant during the EEP (Week 17 to Week 24) was estimated as a time adjusted average.|Week 17 up to Week 24|Per protocol (PP) population included all participants who received at least 1 dose of C.E.R.A. and for whom data for at least 1 follow-up variable was available with the exception of participants who did not fulfill the protocol specified inclusion criteria for this analysis set.||percentage of participants||95% Confidence Interval|Number
768698|NCT00699374|Secondary|European Quality of Life (EQ-5D)- Health State Profile Utility Score|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, confined to bed). Scoring formula assigns a utility value for each domain in the profile. Score is transformed and results in a score range -0.594 to 1.000; higher score indicates better health state."|Day 1 of each cycle|Data were not collected per Amendment 2 to the protocol removing collection for this endpoint.|||||
768699|NCT00699374|Secondary|Time to Tumor Progression (TTP)|Time in weeks from randomization to first documentation of objective tumor progression or death due to cancer, whichever comes first. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD])|Baseline, every 4 weeks during treatment, every 8 weeks posttreatment up to Week 150|Full Analysis Population||Weeks|Participants|95% Confidence Interval|Median
768700|NCT00699374|Secondary|Progression-Free Survival (PFS)|The period from randomization until disease progression or death.|Baseline, every 4 weeks during treatment, every 8 weeks posttreatment up to Week 150|Full Analysis Population||Weeks|Participants|95% Confidence Interval|Median
768701|NCT00699374|Primary|Overall Survival (OS)|Overall survival is the duration from randomization to death. For participants who are alive, overall survival was censored at the last contact.|Baseline, every 4 weeks during treatment, every 8 weeks posttreatment up to Week 150|Full Analysis Population, all randomized participants where participants were classifed according to the randomized treatment arm regardless of what treatment, if any, was received.||Weeks|Participants|95% Confidence Interval|Median
768702|NCT00699400|Secondary|Number of Miscarriages|Number of pregnancy outcomes reported as spontaneous abortions|Anytime after embryo transfer|Participants could have multiple thawing cycles that could lead to multiple embryo transfers. Only successful thaws lead to embryo transfers and only successful embryo transfers lead to clinical pregnancies.||Number of Miscarriages|Participants||Number
768703|NCT00699400|Secondary|Number of Clinical Pregnancies|Number of clinical pregnancies defined as the presence of one or more fetal sacs with a heartbeat.|At time of ultrasound after embryo transfer|Participants could have multiple thawing cycles that could lead to multiple embryo transfers. Only successful thaws lead to embryo transfers and only successful embryo transfers lead to clinical pregnancies.||Number of Clinical Pregnancies|Participants||Number
768704|NCT00699400|Secondary|Implantation Rate|Implantation rate was calculated as the number of fetal sacs per transferred embryo averaged over all thawing cycles|At time of ultrasound after embryo transfer|||Implantation Rate (%)|Participants|Standard Deviation|Mean
768705|NCT00699400|Secondary|Oocyte Survival Rate|Number of oocytes fertilized divided by number of oocytes thawed per thawing cycle|At time of fertilization|||Oocyte survival rate (%)|Participants|Standard Deviation|Mean
768706|NCT00699400|Secondary|Number of Oocytes Thawed||At start of thawing cycle|||Number of oocytes thawed|Participants||Number
768715|NCT00699491|Secondary|Survival Time (Phase II)|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.|Time from registration to death due to any cause|One patient registered to the Phase II portion of the study was not eligible for this endpoint due to eligibility criteria not being met.||months||95% Confidence Interval|Median
768716|NCT00699491|Secondary|Progression Free Survival Rate|Progression free survival (PFS) is defined as the time from registration to documentation of disease progression. A point and interval estimate of the 6 month PFS rate will be obtained using the Kaplan-Meier method.|At 6 months|One patient registered to the Phase II portion of the study was not eligible for this endpoint due to eligibility criteria not being met.||percentage of patients||95% Confidence Interval|Number
768717|NCT00699491|Secondary|Progression Free Survival (PFS) (Phase II)|Progression free survival is defined as the time from registration to documentation of disease progression. If a patient dies without a documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death. If the patient is declared to be a major treatment violation, the patient will be censored on the date the treatment violation was declared to have occurred. In the case of a patient starting treatment and then never returning for any evaluations, the patient will be censored for progression on the last day of therapy was administered. The distribution of progression-free survival times will be estimated using the Kaplan-Meier method.The distribution of PFS times will be estimated using the Kaplan-Meier method.|Time from registration to documentation of disease progression, up to 5 years|One patient registered to the Phase II portion of the study was not eligible for this endpoint due to eligibility criteria not being met.||months||95% Confidence Interval|Median
768718|NCT00699491|Secondary|Duration of Response (Phase II)|Duration of response is defined for all evaluable patients with changes in disease burden that met the RECIST criteria for CR or PR on 2 consecutive evaluations at least 6-8 weeks apart as the date at which the CR or PR to the date progression is documented. The distribution of response durations will be estimated using the Kaplan-Meier method.|Up to 5 years|No patients were eligible for this endpoint.|||||
768719|NCT00699491|Secondary|Adverse Events Graded Using the NCI CTCAE Version. 3 (Phase II)|Adverse events will be graded using the NCI-CTCAE v3.0 coding scheme. The maximum grade for each adverse event considered to be ‘at least possibly related to treatment’ will be recorded. Frequency tables will be constructed and the number of patients reporting an adverse event of grade 3 or higher at least possibly related to treatment will be reported.|Up to 5 years|All patients that received protocol treatment were evaluable for this endpoint.||participants|||Number
768720|NCT00699491|Primary|Tumor Response Rate (TRR) (Complete Response [CR] or Partial Response [PR]) by the Response Evaluation Criteria in Solid Tumors (RECIST) (Phase II)|"A response is defined as a disease burden that meets the RECIST criteria for Complete Response (CR) or Partial Response (PR) on 2 consecutive evaluations at least 6-8 weeks apart.
Complete Response (CR): All of the following must be true:
Disappearance of all target and non-target lesions.
Each target lymph node must have reduction in short axis to <1.0 cm.
Partial Response (PR): At least a 30% decrease in PBSD (sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes at current evaluation) taking as reference the baseline measures.
The rate is calculated by dividing the number of patients with a CR or PR by the number of evaluable patients. A ninety percent confidence interval for the true tumor response rate will be calculated using the Duffy-Santer approach."|Up to 5 years|One patient registered to the Phase II portion of the study was not eligible for this endpoint due to eligibility criteria not being met.||percentage of patients with response||90% Confidence Interval|Number
768721|NCT00699491|Primary|Recommended Dose Level for Phase II Testing (RPTD) (Phase I)|"The RPTD is defined as the highest dose level at which at most one of 6 patients develops a dose limiting toxicity (DLT) during the first course of treatment and the next highest dose level has 2 or more DLTs. The number of patients in each cohort reporting a DLT is reported.
Dose-limiting toxicities (DLTs) are defined as any of the following adverse events (AEs) that are related to study agent with an attribution of possible, probably, or definite and fulfilling one of the following criteria:
Any grade 4 hematologic toxicity
Hyperglycemia that cannot be stably controlled with diabetic medication
Any grade 3 or 4 non-hematologic toxicity (except asymptomatic medically manageable laboratory abnormalities such as hyperlipidemia, hypophosphatemia, and hypokalemia)"|During first course|Patients registered to the Phase I portion of the protocol were analyzed for this endpoint. One patient in Dose Level -1, one patient in Dose Level -2, and two patients in Dose Level -2B discontinued study treatment during Cycle 1 for reasons unrelated to toxicity and were excluded from this endpoint.||DLTs|||Number
768722|NCT00699582|Secondary|Percent Change in the 28-day Complex Partial Plus Secondarily Generalized Seizure Frequency From Baseline to the End of the Double-blind Phase (Titration and Maintenance Phases)|Percent Change in the Seizure frequency per 28 days was derived from the information recorded in the subject diaries.|Baseline (Pre-randomization) through Week 19|Full ITT Analysis Set with Complex Partial plus Secondarily Generalized Seizures at Pre-randomization. For Placebo arm, 2 subjects were randomized but not treated. For Perampanel 8mg arm, 1 subject was randomized but not treated.||Percent Change||Full Range|Median
768723|NCT00699582|Secondary|Responder Rate|The responder rate for the Full ITT Analysis Set from the maintenance LOCF (Last Observation Carried Forward). A responder was a subject who had a 50 percent or greater reduction in seizure frequency per 28 days from the Pre‑randomization phase.|Baseline (Pre-randomization) through Week 19|Full ITT Analysis Set. For Placebo arm, 2 subjects were randomized but not treated. For Perampanel 8mg arm, 1 subject was randomized but not treated.||Percentage of Participants|||Number
768724|NCT00699582|Primary|Percent Change in the 28-day Seizure Frequency From Baseline to the End of the Double-blind Phase (Titration and Maintenance Phases)|Seizure frequency per 28 days was derived from the information recorded in the subject diaries.|Baseline (Pre-randomization) through Week 19|Full Intent-to-Treat (ITT) Analysis Set - group of subjects who were randomized to study drug, received study drug, and had any seizure frequency data during the Doubleblind Phase. For Placebo arm, 2 subjects were randomized but not treated. For Perampanel 8mg arm, 1 subject was randomized but not treated.||Percent Change||Full Range|Median
768744|NCT00699660|Primary|Completeness and Quality of PTSD Interview|total completeness of diagnostic assessment score, range from 0 to 100% and completeness of functional assessment|Post-exam, same day|||percentage of criteria PTSD assessment||Standard Deviation|Mean
768725|NCT00699608|Secondary|Coordination Score, as Assessed by the Linear Analogue Rating Scales|Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind). The Dizziness and Clumsiness scores are averaged to derive an overall “Coordination” score (as described in Outcome Measure 14). Each item was assessed on a 1-100 point scale, where 100 indicates most impaired.|7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)|Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed.||points on a scale||Standard Error|Least Squares Mean
768726|NCT00699608|Secondary|Mood Score, as Assessed by the Linear Analogue Rating Scales|Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind). The Anxiety, Depression, Relaxed, and Sadness scores are averaged to derive an overall “Mood” score (as described in Outcome Measure 14). Each item was assessed on a 1-100 point scale, where 100 indicates most impaired.|7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)|Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed.||points on a scale||Standard Error|Least Squares Mean
768727|NCT00699608|Secondary|Sedation Score, as Assessed by the Linear Analogue Rating Scales|The Linear Analogue Rating Scale (LARS) is used as a measure of the subjective effects of psychoactive drugs. Participants mark a series of 10 cm (100 unit line) analogue scales (1-100, 100 = most impaired) relating to dizzy, clumsy, anxious, relaxed, tired, drowsy, alert, energetic, sad, and depressed, indicating their present feeling with regard to a mid-point, representing their “usual” state of mind before treatment began. The higher the score, the more impaired the participant feels. The Tiredness, Alertness, Energy, and Drowsiness scores are averaged to derive an overall Sedation score.|7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)|Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed.||points on a scale||Standard Error|Least Squares Mean
768728|NCT00699608|Secondary|3-Back Reaction Time|Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind). Reaction time is the time taken to respond to a stimulus.|7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)|Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed.||milliseconds||Standard Error|Least Squares Mean
768729|NCT00699608|Secondary|1-Back Reaction Time|Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind). Reaction time is the time taken to respond to a stimulus.|7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)|Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed.||milliseconds||Standard Error|Least Squares Mean
768730|NCT00699608|Secondary|3-Back Percentage of Correct Responses|Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind). In “3-back” tasks, a comparison is made between the current stimulus and the two before the immediately preceding stimulus. In the versions of the tests used in this study, the stimuli are presented on screen for 500 ms, and the interval between stimuli is 2500 ms, with a ratio of 1:2 of “match” trials to non-match trials. The duration of the test is 2 min. The percentage of correct responses is the percentage of correct responses given in 2 min.|7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)|Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed.||percentage of responses||Standard Error|Least Squares Mean
768731|NCT00699608|Secondary|1-Back Percentage of Correct Responses|The N-Back task requires the participant to indicate, using the mouse, whether the current stimulus presented on the screen and the one immediately before it visually match (i.e., “one-back”). In the versions of the tests used in this study, the stimuli are presented on screen for 500 ms, and the interval between stimuli is 2500 ms, with a ratio of 1:2 of “match” trials to non-match trials. The duration of the test is 2 minutes. The percentage of correct responses is the percentage of correct responses given in 2 minutes.|7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)|Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed.||percentage of responses||Standard Error|Least Squares Mean
768732|NCT00699608|Secondary|Total Number of Correct Symbol Substitutions, as Assessed by the Digital Symbol Substitution Test|Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind). The Digit Symbol Substitution Test (DSST) is a pen and paper test that consists of rows of blank squares paired with randomly assigned digits (between 0 and 9). Participants are required to substitute each digit with a different nonsense symbol, according to a key printed at the top of the sheet that indicates the nonsense symbol that corresponds to each digit. Participants are given 120 seconds in which to complete the test.|7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)|Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed.||number of substitutions||Standard Error|Least Squares Mean
768745|NCT00699699|Secondary|Patients' Satisfaction After 6 Weeks of Treatment|"Patients' satisfaction with the Spiriva® Respimat® device after 6 weeks of treatment (very satisfied, satisfied, rather satisfied, neither satisfied nor unsatisfied, rather unsatisfied, unsatisfied, and very unsatisfied)"|6 weeks|There were 1260 patients who had evaluable PGE after 6 weeks||Participants|||Number
769572|NCT00706004|Secondary|Serum Albumin||baseline and 4 weeks|Participants who completed the study||g/dL||Standard Deviation|Mean
768733|NCT00699608|Secondary|Total Number of Attempted Symbol Substitutions, as Assessed by the Digit Symbol Substitution Test|Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind). The Digit Symbol Substitution Test (DSST) is a pen and paper test that consists of rows of blank squares paired with randomly assigned digits (between 0 and 9). Participants are required to substitute each digit with a different nonsense symbol, according to a key printed at the top of the sheet that indicates the nonsense symbol that corresponds to each digit. Participants are given 120 seconds in which to complete the test.|7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)|Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed.||number of substitutions||Standard Error|Least Squares Mean
768734|NCT00699608|Secondary|Critical Flicker Fusion Test–Overall Threshold|Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind) The mean of the four ascending and four descending presentations of the CFF give the overall threshold frequency in hertz.|7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)|Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed.||hertz||Standard Error|Least Squares Mean
768735|NCT00699608|Secondary|Critical Flicker Fusion Test –Descending Threshold|Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind) The mean of the four descending presentations from the CFF give the descending threshold frequency in hertz.|7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)|Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication.Only participants who had assessment of the measure the day after double-blind treatment were analyzed.||hertz||Standard Error|Least Squares Mean
768736|NCT00699608|Secondary|Critical Flicker Fusion Test–Ascending Threshold|Critical Flicker Fusion (CFF) is a validated cognitive assessment task that provides an index of central nervous system (CNS) activity and attention modulated motion detection. Participants are required to discriminate flicker from fusion, and vice versa, in a set of four light-emitting diodes arranged in a one-centimetre square. These diodes are held in foveal fixation when viewed at a distance of one metre. Individual thresholds are determined on four ascending and four descending scales. The mean of the four ascending presentations give the ascending threshold frequency in hertz.|7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)|Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed.||hertz||Standard Error|Least Squares Mean
768737|NCT00699608|Secondary|CTT Mean Reaction Time|Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind) A further outcome derived from the CTT is a peripheral awareness task where the participant responds to a stimulus presented in the periphery of vision, while simultaneously attending to the tracking test. The mean reaction time, in milliseconds, to these stimuli over the trial period is taken as the response measure for this component of the divided attention task. A lower mean reaction time is indicative of better peripheral awareness.|7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)|Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication.Only participants who had assessment of the measure the day after double-blind treatment were analyzed.||milliseconds||Standard Error|Least Squares Mean
768738|NCT00699608|Secondary|Mean Tracking Error (MTE) Assessed During the CTT|Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind) . The CTT is a task (8 minute duration) of psychomotor function that entails using a slider to keep a cursor in alignment with a moving target on a visual display unit screen. The movement of the target is the function of an irregular sine wave, and cursor accuracy is measured by the MTE, the difference between the centers of target and cursor in pixels, sampled 5 times per second, over the test. Lower scores are indicative of more accurate tracking.|7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)|Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed.||pixels||Standard Error|Least Squares Mean
768739|NCT00699608|Primary|Mean Tracking Error Assessed During the Continuous Tracking Test (CTT)|Analysis was performed on the mean of the five assessments conducted 7.5, 8, 8.5, 9, and 9.5 hours post-dose (double-blind) The CTT is a task (duration of 8 minutes) of psychomotor function that entails using a slider to keep a cursor in alignment with a moving target on a visual display unit screen. The movement of the target is the function of an irregular sine wave, and cursor accuracy is measured by the mean tracking error - the difference between the centers of target and cursor in pixels, sampled 5 times per second, over the test. Lower scores are indicative of more accurate tracking.|7.5, 8, 8.5, 9, and 9.5 hours post-dose (double-blind)|Intent-to-Treat (ITT) Population: all subjects who gave informed consent, were randomised, and received at least one dose of double-blind medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed.||pixels||Standard Error|Least Squares Mean
768740|NCT00699660|Secondary|Resource Utilization|time spent administering the exam|same day|||minutes||Standard Deviation|Mean
768741|NCT00699660|Secondary|Patient Satisfaction|Mean score on satisfaction survey rating scale from 1 to 5 (higher)|post-exam, same day|||units on a scale||Standard Deviation|Mean
768742|NCT00699660|Secondary|PTSD Diagnosis|Number of participants who were unable to receive a conclusive clinician PTSD diagnosis for positive or negative PTSD symptoms (unable to determine clinician diagnosis).|Post-exam, same day|||participants|||Number
768743|NCT00699660|Secondary|PTSD Diagnosis|Number of participants who were unable to receive a conclusive clinician PTSD diagnosis for positive or negative PTSD symptoms(unable to determine accuracy of clinician diagnosis).|post-exam, same day||||||
769573|NCT00706004|Secondary|Serum Prealbumin||baseline and 4 weeks|Participants who completed the study||mg/dL||Standard Deviation|Mean
768746|NCT00699699|Secondary|Change From Baseline After 6 Weeks in Physician's Global Evaluation (PGE) Form Safety|"Changes in Physician's Global Evaluation in physical functioning from baseline after 6 weeks of treatment (measured as 8 point scale with classifications poor (1, 2), satisfactory (3, 4), good (5, 6), and excellent (7, 8))"|Baseline and after 6 weeks of treatment|There were 1260 patients who had evaluable PGE at both baseline and after 6 weeks||PGE scale points||Standard Deviation|Mean
768747|NCT00699699|Secondary|Change From Baseline in the PF-10 Score After 6 Weeks|Numerical changes in physical functioning (PF-10) after 6 weeks of treatment. PF-10 (subdomain of SF-36) score (range from 0 to 100, 0 reflects worst and 100 best condition)|Baseline and after 6 weeks of treatment|There were 1230 patients who had evaluable PF-10 measurement at both baseline and after 6 weeks||PF-10 score points||Standard Deviation|Mean
768748|NCT00699699|Primary|Therapeutic Success as Change From Baseline in Physical Functioning After 6 Weeks|Main efficacy measure was therapeutic success rate defined as an improvement from baseline after 6 weeks by at least 10 score points in the PF-10 (subdomain of SF-36) score (range from 0 to 100, 0 reflects worst and 100 best condition)|Baseline and after 6 weeks of treatment|There were 1230 patients who had evaluable PF-10 measurement at both baseline and after 6 weeks||Percentage of participants|||Number
768749|NCT00699751|Other Pre-specified|Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Follow-up Visit 8 (Week 139)|The EQ-5D questionnaire was given to the subject at each visit. The EQ-5D questionnaire consisted of 5 ordinal categorical responses (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Number of participants with EQ-5D at follow-up visit 8, as measured by this questionnaire, was counted. The scores for the EQ-5D dimensions are assigned according to the level of problems reported (1 ‘no problems’; 2 ‘some problems’; 3 ‘extreme problems’).|Follow-up Visit 8 (Week 139)|The ITT population was all randomized subjects with with EQ-5D analyzed.||Participants|||Number
768750|NCT00699751|Other Pre-specified|Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 24|The EQ-5D questionnaire was given to the subject at each visit. The EQ-5D questionnaire consisted of 5 ordinal categorical responses (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Number of participants with EQ-5D at Week 24, as measured by this questionnaire, was counted. The scores for the EQ-5D dimensions are assigned according to the level of problems reported (1 ‘no problems’; 2 ‘some problems’; 3 ‘extreme problems’).|Week 24|The ITT population was all randomized subjects with with EQ-5D analyzed.||Participants|||Number
768751|NCT00699751|Other Pre-specified|Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 16|The EQ-5D questionnaire was given to the subject at each visit. The EQ-5D questionnaire consisted of 5 ordinal categorical responses (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Number of participants with EQ-5D at Week 16, as measured by this questionnaire, was counted. The scores for the EQ-5D dimensions are assigned according to the level of problems reported (1 ‘no problems’; 2 ‘some problems’; 3 ‘extreme problems’).|Week 16|The ITT population was all randomized subjects with with EQ-5D analyzed.||Participants|||Number
768752|NCT00699751|Other Pre-specified|Change From Baseline for FACT-G Total Score at Week 16, Week 24, and Follow-up Visit 2 (Week 42)|The FACT-G instrument consisted of 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being. Total possible score was 108; a higher score indicates a better quality of life. The changes from baseline in the FACT-G total score (physical, social/family, emotional, and functional well-being) were calculated at Week 16, Week 24, and Follow-up Visit 2. Possible range was -108 to 108.|Baseline, Week 16, Week 24, and Follow-up Visit 2 (Week 42)|The ITT population was all randomized subjects||Scores on a scale||Full Range|Median
768753|NCT00699751|Other Pre-specified|Absolute Scores for Functional Assessment of Cancer Therapy – General (FACT-G) Total Score at Week 16, Week 24, and Follow-up Visit 2 (Week 42)|The FACT-G instrument consisted of 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being. The FACT-G absolute total score (physical, social/family, emotional, and functional well-being) was calculated at Week 16, Week 24, and Follow-up Visit 2. FACT-G Total Score: Physical Well-being (PWB) + Social/Family Well-being (SWB) + Emotional Well-being (EWB) + Functional Well-being (FWB). Score ranges from 0 (worst) to 108 (best).|At Week 16, Week 24, and Follow-up Visit 2 (Week 42)|The ITT population was all randomized subjects||Scores on a scale||Full Range|Median
768754|NCT00699751|Other Pre-specified|Change From Baseline for FACT-P Total Score at Week 16, Week 24, and Follow-up Visit 2 (Week 42)|The FACT-P was 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being. It was supplemented by 12 questions relating to prostate cancer. Total possible score was 156; a higher score indicates a better quality of life. The changes from baseline in the FACT-P total score (physical, social/family, emotional, and functional well-being and prostate specific score) were calculated at Week 16, Week 24, and Follow-up Visit 2. Possible range was -156 to 156.|Baseline, Week 16, Week 24, and Follow-up Visit 2 (week 42)|The ITT population was all randomized subjects||Scores on a scale||Full Range|Median
768755|NCT00699751|Other Pre-specified|Absolute Scores for FACT-P Total Score at Week 16, Week 24, and Follow-up Visit 2 (Week 42)|The FACT-P was 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being. It was supplemented by 12 questions relating to prostate cancer. The absolute score of the FACT-P total score (physical, social/family, emotional, and functional well-being and prostate specific score) was calculated at Week 16, Week 24, and Follow-up Visit 2.FACT-P Total Score: Physical Well-being (PWB) + Social/Family Well-being (SWB) + Emotional Well-being (EWB) + Functional Well-being (FWB) + Prostate Cancer (PCS). Score ranges from 0 (worst) to 156 (best).|At Week 16, Week 24, and Follow-up Visit 2 (Week 42)|The ITT population was all randomized subjects||Scores on a scale||Full Range|Median
768777|NCT00699751|Secondary|Percentage of Participants With PSA Response at EOT (Week 24 or at the Time the Patient Dies or Discontinues Treatment Phase)|PSA levels were measured in participants' blood at EOT (Week 24) and compared to baseline values. A confirmed PSA response (>/=50% reduction from baseline) was confirmed by a second PSA value approximately 4 weeks later.|At Baseline and End of Treatment (Week 24 or at the time the patient dies or discontinues treatment phase)|Participants in The ITT population and had no missing values for this outcome measure||Percentage of participants|||Number
769574|NCT00706004|Secondary|Serum Vitamin E||baseline and 4 weeks|Participants who completed the study||mg/L||Standard Deviation|Mean
768756|NCT00699751|Other Pre-specified|Absolute Scores for Physical Well Being, Social/Family Well Being, Emotional Well Being, Functional Well Being, and the Prostate Cancer Subscale at Follow-up Visit 2 (Week 42)|The FACT-P was 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being and was supplemented by 12 questions relating to prostate cancer. Possible scores for each subscale were 0 to 28; 0 to 28; 0 to 24; 0 to 28; and 0 to 48, respectively. All FACT-P items are scored on a scale of 0-4 representing the extent to which the item reflects the experience of the individual completing the instrument (0 – Not at all; 4 – Very much). Higher scores indicate better quality of life. The absolute score of the FACT-P total score was calculated at Follow-up Visit 2.|At Follow-up Visit 2 (Week 42)|The ITT population was all randomized subjects||Scores on a scale||Full Range|Median
768757|NCT00699751|Other Pre-specified|Absolute Scores for Physical Well Being, Social/Family Well Being, Emotional Well Being, Functional Well Being, and the Prostate Cancer Subscale at Week 24|The FACT-P was 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being and was supplemented by 12 questions relating to prostate cancer. Possible scores for each subscale were 0 to 28; 0 to 28; 0 to 24; 0 to 28; and 0 to 48, respectively. All FACT-P items are scored on a scale of 0-4 representing the extent to which the item reflects the experience of the individual completing the instrument (0 – Not at all; 4 – Very much). Higher scores indicate better quality of life. The absolute score of the FACT-P total score was calculated at Week 24.|At Week 24|The ITT population was all randomized subjects||Scores on a scale||Full Range|Median
768758|NCT00699751|Other Pre-specified|Absolute Scores for Physical Well Being, Social/Family Well Being, Emotional Well Being, Functional Well Being, and the Prostate Cancer Subscale at Week 16|The FACT-P was 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being and was supplemented by 12 questions relating to prostate cancer. Possible scores for each subscale were 0 to 28; 0 to 28; 0 to 24; 0 to 28; and 0 to 48, respectively. All FACT-P items are scored on a scale of 0-4 representing the extent to which the item reflects the experience of the individual completing the instrument (0 – Not at all; 4 – Very much). Higher scores indicate better quality of life. The absolute score of the FACT-P total score was calculated at Week 16.|At Week 16|The ITT population was all randomized subjects||Scores on a scale||Full Range|Median
768759|NCT00699751|Other Pre-specified|Changes From Baseline for FACT-P Trial Outcome Index (TOI) at Week 16, Week 24, and Follow-up Visit 2 (Week 42)|The FACT-P was 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being. It was supplemented by 12 questions relating to prostate cancer. The absolute score for the FACT-P TOI domain (physical and social well-being and prostate specific score) was calculated for each visit. Possible scores were 0 to 104; the higher the score, the better the quality of life. The changes from baseline (range -104 to 104) in the domain FACT-P TOI were summarized using descriptive statistics at Week 16, Week 24, and Follow-up Visit 2.|Baseline, Week 16, Week 24, and Follow-up Visit 2 (Week 42)|The ITT population was all randomized subjects||Scores on a scale||Full Range|Median
768760|NCT00699751|Other Pre-specified|Absolute Scores for Functional Assessment of Cancer Therapy – Prostate (FACT-P) Trial Outcome Index (TOI)|The FACT-P was 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being. It was supplemented by 12 questions relating to prostate cancer. The absolute score for the FACT-P TOI domain (physical and social well-being and prostate specific score) was calculated for each visit. Prostate Cancer Trial Outcome Index (TOI): Physical Well-being (PWB) + Functional Well-being (FWB) + Prostate Cancer (PCS). Score ranges from 0 (worst) to 104 (best).|Baseline, Week 16, Week 24, and Follow-up Visit 2 (Week 42)|The ITT population was all randomized subjects||Scores on a scale||Full Range|Median
768761|NCT00699751|Other Pre-specified|Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 24.|ECOG PS was defined as: 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (eg, light house work, office work); 2 = Ambulatory and capable of all self-care but unable to carry out work activities. Up and about > 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair > 50% of waking hours; 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; or 5 = Dead.|Week 24|Participants in The ITT population and with ECOG analyzed||Participants|||Number
768762|NCT00699751|Other Pre-specified|Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 16.|ECOG PS was defined as: 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (eg, light house work, office work); 2 = Ambulatory and capable of all self-care but unable to carry out work activities. Up and about > 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair > 50% of waking hours; 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; or 5 = Dead.|Week 16|Participants in The ITT population and with ECOG analyzed||Participants|||Number
768763|NCT00699751|Other Pre-specified|Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 8.|ECOG PS was defined as: 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (eg, light house work, office work); 2 = Ambulatory and capable of all self-care but unable to carry out work activities. Up and about > 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair > 50% of waking hours; 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; or 5 = Dead.|Week 8|Participants in The ITT population and with ECOG analyzed||Participants|||Number
768764|NCT00699751|Other Pre-specified|Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 0.|ECOG PS was defined as: 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (eg, light house work, office work); 2 = Ambulatory and capable of all self-care but unable to carry out work activities. Up and about > 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair > 50% of waking hours; 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; or 5 = Dead.|Week 0|Participants in The ITT population and with ECOG analyzed||Participants|||Number
769575|NCT00706004|Secondary|Serum Vitamin A||baseline and 4 weeks|Participants who completed the study||ug/dL||Standard Deviation|Mean
768765|NCT00699751|Secondary|Time to Occurrence of First Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) by at Least 2 Points From Baseline|ECOG scores were: 0 = fully active; 1 = restricted in physically strenuous activity; 2 = ambulatory and capable of all self-care but unable to work; 3 = capable of only limited self-care; 4 = completely disabled; 5 = death. The visit at which a 2-point or more deterioration in PS was observed was the time of the event. ECOG was assessed at every visit. If a marked deterioration in PS has not occurred at the time of the analysis or the participant was lost to follow-up, the time-to-event variables were censored at the last assessment date.|From randomization to first deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) until approximately 3 years after start of enrollment|The ITT population was all randomized subjects||Months||95% Confidence Interval|Median
768766|NCT00699751|Secondary|Time to Occurrence of First Start of Any Other Anti-cancer Treatment|The start date of the treatment was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.|From randomization to first start of any other anti-cancer treatment until approximately 3 years after start of enrollment|The ITT population was all randomized subjects||Months||95% Confidence Interval|Median
768767|NCT00699751|Secondary|Time to Occurrence of First Spinal Cord Compression|The start date of the compression was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.|From randomization to first spinal cord compression until approximately 3 years after start of enrollment|The ITT population was all randomized subjects||Months||95% Confidence Interval|Median
768768|NCT00699751|Secondary|Time to Occurrence of First Tumor Related Orthopedic Surgical Intervention|The start date of the intervention was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.|From randomization to occurrence of first tumor related orthopedic surgical intervention until approximately 3 years after start of enrollment|The ITT population was all randomized subjects||Months||95% Confidence Interval|Median
768769|NCT00699751|Secondary|Time to Occurrence of First New Symptomatic Pathological Bone Fractures, Vertebral and Non-vertebral|The start date of the event was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.|From randomization to occurrence of first new symptomatic pathological bone fractures until approximately 3 years after start of enrollment|The ITT population was all randomized subjects||Months||95% Confidence Interval|Median
768770|NCT00699751|Secondary|Time to Occurrence of First Use of Radioisotopes to Relieve Skeletal Symptoms|The start date of the radioisotopes was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.|From randomization to first use of radioisotopes until approximately 3 years after start of enrollment|The ITT population was all randomized subjects||Months||95% Confidence Interval|Median
768771|NCT00699751|Secondary|Time to Occurrence of First Use of External Beam Radiation Therapy (EBRT) to Relieve Skeletal Symptoms|The start date of therapy was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.|From randomization to first EBRT until approximately 3 years after start of enrollment|The ITT population was all randomized subjects||Months||95% Confidence Interval|Median
768772|NCT00699751|Secondary|Time to First Skeletal Related Event (SRE)|A skeletal related event is the use of external beam radiotherapy to relieve skeletal symptoms or the occurrence of new symptomatic pathological bone fractures (vertebral or non-vertebral) or the occurrence of spinal cord compression or a tumour related orthopaedic surgical intervention. For all other events, the start date of the event/medication/therapy was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.|From randomization to first first SRE until approximately 3 years after start of enrollment|The ITT population was all randomized subjects||Months||95% Confidence Interval|Median
768773|NCT00699751|Secondary|Maximum Percentage Decrease From Baseline in PSA Response During the 24 Week Treatment Period|PSA level was measured in participant's blood during the 24 week treatment (up to EOT) and the maximum percent decrease from baseline during the 24 Week treatment value was calculated as the minimum value of [(PSA level up to week 24 minus PSA level at baseline)/(PSA level at baseline)*100] by participant, and set to zero if no decrease from baseline.|From baseline to End of Treatment (Week 24; 4 weeks post last injection)|Participants in The ITT population and had no missing values for this outcome measure||Percentage change||Standard Error|Least Squares Mean
768774|NCT00699751|Secondary|Percentage Change From Baseline in PSA at EOT (Week 24 or at the Time the Patient Dies or Discontinues Treatment Phase)|PSA level was measured in subject’s blood at EOT (Week 24) and the percent change from the baseline value was calculated (PSA level at EOT minus PSA level at baseline)/(PSA level at baseline)*100|At Baseline and End of Treatment (Week 24 or at the time the patient dies or discontinues treatment phase)|Participants in The ITT population and had no missing values for this outcome measure||Percentage change||Standard Error|Least Squares Mean
768775|NCT00699751|Secondary|Maximum Percentage Decrease From Baseline in PSA up to Week 12|PSA level was measured in participant's blood up to Week 12 and the maximum percent decrease from the baseline up to week 12 value was calculated as the minimum value of [(PSA level up to week 12 minus PSA level at baseline)/(PSA level at baseline)*100] by participant, and set to zero if no decrease from baseline.|From baseline up to Week 12|Participants in The ITT population and had no missing values for this outcome measure||Percentage change||Standard Error|Least Squares Mean
768776|NCT00699751|Secondary|Percentage Change From Baseline in PSA at Week 12|PSA level was measured in subject's blood at Week 12 and the percent change from the baseline value was calculated (PSA level at week 12 minus PSA level at baseline)/(PSA level at baseline)*100|At Baseline and Week 12|Participants in The ITT population and had no missing values for this outcome measure||Percent change||Standard Error|Least Squares Mean
769576|NCT00706004|Secondary|Serum Vitamin D||baseline and 4 weeks|Participants who completed the study||ng/mL||Standard Deviation|Mean
768778|NCT00699751|Secondary|Percentage of Participants With PSA Response at Week 12|PSA levels were measured in participants' blood at Week 12 and compared to baseline values. A confirmed PSA response (>/=50% reduction from baseline) was confirmed by a second PSA value approximately 4 weeks later.|At Baseline and Week 12|Participants in The ITT population and had no missing values for this outcome measure||Percentage of participants|||Number
768779|NCT00699751|Secondary|Time to Prostate Specific Antigen (PSA) Progression|The time from the first study drug administration to when PSA progression was observed, defined as: 1) In subjects with no PSA decline from baseline; a greater than or equal to 25% increase from baseline value and an increase in absolute value of greater than or equal to 2 ng/mL, at least 12 weeks from baseline; 2) In subjects with initial PSA decline from baseline; the time from start of treatment to first PSA increase that is greater than or equal to 25% increase and at least 2 ng/mL above the nadir value, which was confirmed by a second value obtained 3 or more weeks later|From randomization to first PSA progression until approximately 3 years after start of enrollment|The ITT population was all randomized subjects||Months||95% Confidence Interval|Median
768780|NCT00699751|Secondary|Maximum Percentage Decrease From Baseline in Total ALP During the 24 Week Treatment|ALP level was measured in participant's blood during the 24 week treatment (up to EOT) and the maximum percent decrease from baseline during the 24 week treatment value was calculated as the minimum value of [(ALP level up to week 24 minus ALP level at baseline)/(ALP level at baseline)*100] by participant, and set to zero if no decrease from baseline.|From baseline During the 24 Week Treatment|Participants in The ITT population and had no missing values for this outcome measure||Percentage change||Standard Error|Least Squares Mean
768781|NCT00699751|Secondary|Percentage Change From Baseline in Total ALP at EOT (Week 24 or at the Time the Patient Dies or Discontinues Treatment Phase)|ALP level was measured in subject's blood at EOT (Week 24) and the percent change from the baseline value was calculated (ALP level at EOT minus ALP level at baseline)/(ALP level at baseline)*100|At Baseline and End of Treatment (Week 24 or at the time the patient dies or discontinues treatment phase)|Participants in The ITT population and had no missing values for this outcome measure||Percent change||Standard Error|Least Squares Mean
768782|NCT00699751|Secondary|Maximum Percentage Decrease From Baseline in Total ALP up to Week 12|ALP level was measured in participant's blood up to week 12 and the maximum percent decrease from the baseline up to Week 12 value was calculated as the minimum value of [(ALP level up to week 12 minus ALP level at baseline)/(ALP level at baseline)*100] by participant, and set to zero if no decrease from baseline.|From baseline to Week 12|Participants in The ITT population and had no missing values for this outcome measure||Percentage change||Standard Error|Least Squares Mean
768783|NCT00699751|Secondary|Percentage Change From Baseline in Total ALP at Week 12|ALP level was measured in subject's blood at Week 12 and the percent change from the baseline value was calculated (ALP level at week 12 minus ALP level at baseline)/(ALP level at baseline)*100|At Baseline and Week 12|Participants in The ITT population and had no missing values for this outcome measure||Percentage change||Standard Error|Least Squares Mean
768784|NCT00699751|Secondary|Percentage of Participants With Total ALP Normalization at Week 12|The return of total ALP value to within normal range at 12 weeks in 2 consecutive measurements (at least 2 weeks apart) after start of treatment in subjects who had ALP above the upper limit of normal (ULN) at baseline.|At Baseline and Week 12|Participants in The ITT population and had no missing values for this outcome measure||Percentage of participants|||Number
768785|NCT00699751|Secondary|Percentage of Participants With Total ALP Response at End of Treatment (EOT; Week 24 or at the Time the Patient Dies or Discontinues Treatment Phase)|ALP levels were measured in participants' blood at EOT (Week 24) and compared to baseline values. A confirmed total ALP response (>/=50% reduction from baseline) was confirmed by a second total ALP value approximately 4 weeks later.|At Baseline and End of Treatment (Week 24 or at the time the patient dies or discontinues treatment phase)|Participants in The ITT population and had no missing values for this outcome measure||Percentage of participants|||Number
768786|NCT00699751|Secondary|Percentage of Participants With Total ALP Response at Week 12|ALP levels were measured in participants' blood at Week 12 and compared to baseline values. A confirmed total ALP response (either >/= 30% or 50% reduction from baseline) was confirmed by a second total ALP value approximately 4 weeks later.|At Baseline and Week 12|Participants in The ITT population and had no missing values for this outcome measure||Percentage of participants|||Number
768787|NCT00699751|Secondary|Time to Total Alkaline Phosphatase (ALP) Progression|The time from the first study drug administration to when ALP progression was observed, defined as: 1) In subjects with no ALP decline from baseline; a greater than or equal to 25% increase from baseline value and an increase in absolute value of greater than or equal to 2 ng/mL, at least 12 weeks from baseline; 2) In subjects with initial ALP decline from baseline; the time from start of treatment to first ALP increase that is greater than or equal to 25% increase and at least 2 ng/mL above the nadir value, which was confirmed by a second value obtained 3 or more weeks later|From randomization to first ALP progression until approximately 3 years after start of enrollment|The ITT population was all randomized subjects.||Months||95% Confidence Interval|Median
768788|NCT00699751|Primary|Overall Survival|Overall survival was defined as the time from date of randomization to the date of death.|From randomization to death due to any cause until approximately 3 years after start of enrollment, the data was collected up to the second data analysis date (15 JUL 2011)|The intent-to-treat (ITT) population was defined as all randomized subjects.||Months||95% Confidence Interval|Median
768789|NCT00705432|Secondary|Number of Participants With Early Virologic Response (Undetectable HCV-RNA at Treatment Week 4, 8, 12, 16, or 20) Who Achieved SVR|"Participants with early virologic response were those who had undetectable HCV-RNA by treatment week 4, 8, 12, 16, or 20. Participants who had undetectable plasma HCV-RNA at FW 24 had SVR. The number of participants with early virologic response that also achieved SVR is reported.
HCV-RNA in participant's plasma samples was detected by a nucleic acid amplification assay with a limit of detection of 9.3 IU/mL."|At Treatment Week 4, 8, 12, 16, 20|Participants that had undetectable HCV RNA for the treatment weeks 4, 8, 12, 16, and 20.||Participants|||Number
768825|NCT00705614|Primary|Number of Participant Fatalities|The number of participant fatalities was evaluated throughout the study.|Up to 5 Years|The population consisted of all enrolled participants. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.||Participants|||Number
769577|NCT00706004|Secondary|Serum Glucose||baseline and 4 weeks|Participants who completed the study||mg/dL||Standard Deviation|Mean
768790|NCT00705432|Secondary|Number of Participants With Early Virologic Response (Undetectable HCV-RNA at Treatment Week 2, 4, 8, 12, 16, or 20)|"Early virologic response was defined as undetectable HCV-RNA at in participants by treatment week 2, 4, 8, 12, 16, or 20.
HCV-RNA in participant's plasma samples was detected by a nucleic acid amplification assay with a limit of detection of 9.3 IU/mL."|At Treatment Week 2, 4, 8, 12, 16, or 20|Full analysis set (FAS). All randomized participants who received at least one dose of any study medication (PEG, RBV or boceprevir).||Participants|||Number
768791|NCT00705432|Secondary|Number of Participants With Undetectable HCV-RNA at Follow-up Week 12 and at 72 Weeks After Randomization.|"Previously untreated adults with CHC genotype 1 were treated with the assigned study medication. The number of participants who had undetectable plasma HCV-RNA at FW 12, and 72 weeks after randomization are reported.
HCV-RNA was detected by a nucleic acid amplification test and the limit of detection for this assay is 9.3 IU/mL."|At FW 12 and at 72 weeks after randomization|Full analysis set (FAS). All randomized participants who received at least one dose of any study medication (PEG, RBV or boceprevir).||Participants|||Number
768792|NCT00705432|Secondary|Sustained Virologic Response (SVR) Rate in Participants Treated With Study Drug (Boceprevir or Placebo)|"Previously untreated adults with CHC genotype 1 were treated with the assigned study medication. Participants who had undetectable plasma HCV-RNA at FW 24 had achieved SVR. SVR rate was the percentage of participants treated with at least one dose of boceprevir or placebo who had achieved SVR.
HCV-RNA in participant's plasma samples was detected by a nucleic acid amplification assay with a limit of detection of 9.3 IU/mL.
If a participant was missing data at FW 24 after having had undetectable HCV-RNA at FW 12, the participant was to be considered to have a SVR."|At FW 24|Modified intent-to-treat set (mITT). All randomized participants who received at least one dose of boceprevir or placebo.||Percentage of participants|||Number
768793|NCT00705432|Primary|Sustained Virologic Response (SVR) Rate|"Previously untreated adults with CHC genotype 1 were treated with the assigned study medication. Participants who had undetectable plasma HCV-RNA at FW 24 had achieved SVR. SVR rate is the percent of participants achieving SVR.
HCV-RNA was detected by a nucleic acid amplification test and the limit of detection for this assay is 9.3 IU/mL.
If a participant was missing data at FW 24 after having had undetectable HCV-RNA at FW 12, the participant was to be considered to have SVR."|At Follow-up Week (FW) 24|Full analysis set (FAS). All randomized participants who received at least one dose of any study medication (PEG, RBV or boceprevir).||Percentage of participants|||Number
768794|NCT00705523|Secondary|Addiction Severity Index (ASI) Alcohol Composite Score at End of Study.|The Addiction Severity Index (ASI) is a semistructured interview that measures the severity of addiction in 25 questions concerning seven problem areas: medical problems, employment problems, drug use, alcohol use, family and social problems, criminality, and psychiatric problems. Each problem area is measured as its own Compsite Score. Each Composite Score total ranges between 0 (no endorsement of any problems) and 1 (maximal endorsement of all problems). Higher scores (i.e., those closer to 1) on each Composite Score indicate more difficulty/lower functioning in that area, while lower scores (i.e., those closer to 0) indicate higher functioning/less difficulty in that area. As such, the Addiction Severity Index (ASI) Alcohol Composite Total Score must fall between 0 and 1, and scores closer to 1 suggest continued problem drinking.|12 weeks of treatment, with a follow-up one month after treatment|||alcohol composite score||Standard Deviation|Mean
768795|NCT00705523|Primary|Rate of Heavy Drinking Days Per Week.|Rate of heavy drinking days per week (defined as five drinks per day for men, four drinks per day for women) as determined by self-report on the time-line follow-back (TLFB).|12 weeks of treatment and one month follow-up|||rate of heavy drinking days per week||Standard Deviation|Median
768796|NCT00705536|Secondary|Area Under the Glucose Infusion Rate Curve From 0 to 360 Minutes After Injection (AUC[GIR{0-360}])|The area under glucose infusion rate curve from minutes (min) 0 to 360 after injection (AUC[GIR{0-360}]) for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase (rHuPH20) was measured from blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 min prior to treatment, every 3 min from min 0 through 60, every 15 min from min 60 through 180, and every 60 min from min 180 to 360 during the clamp. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period.|Predose and up to 360 minutes postdose during Stage 1 or Stage 2|Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable AUC(GIR[360]) data.||Grams per kilogram||Standard Deviation|Mean
768797|NCT00705536|Secondary|Area Under the Glucose Infusion Rate Curve From 0 to 240 Minutes After Injection (AUC[GIR{0-240}])|The area the glucose infusion rate curve from minutes (min) 0 to 240 after injection (AUC[GIR{0-240}]) for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase (rHuPH20) was measured from blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 min prior to treatment, every 3 min from min 0 through 60, every 15 min from min 60 through 180, and every 60 min from min 180 to 240 during the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period.|Predose up to 240 minutes postdose during Stage 1 or Stage 2|Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable AUC(GIR[240]) data.||Grams per kilogram||Standard Deviation|Mean
768798|NCT00705536|Secondary|Area Under the Glucose Infusion Rate Curve From 0 to 180 Minutes After Injection (AUC[GIR{0-180}])|The area under the curve for the glucose infusion rate from minutes (min) 0 to 180 after injection (AUC[GIR{0-180}]) for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase (rHuPH20) was measured from blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 min prior to treatment, every 3 min from min 0 through 60, and every 15 min from min 60 through 180 during the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period.|Predose and up to 180 minutes postdose during Stage 1 or Stage 2|Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable AUC(GIR[180]) data.||Grams per kilogram||Standard Deviation|Mean
768860|NCT00708071|Secondary|Differences From Day 0 in Two-Point Discrimination Tests Days 3, 7, 10, 14|Two-point discrimination test performed by investigators to assess nerve regeneration. Testing performed on each side of the face (SoC and FS VH S/D 4). Differences are calculated as: Postoperative Day - Day 0, reported as minimal distance at which participants were able to discern feeling at two distinct points|Postoperative Days 3, 7, 10, and 14|Per protocol||mm||Full Range|Median
768799|NCT00705536|Secondary|Area Under the Glucose Infusion Rate Curve From 0 to 120 Minutes After Injection (AUC[GIR{0-120}])|The area under the glucose infusion rate curve from minutes 0 to 120 after injection (AUC[GIR{0-120}]) for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase (rHuPH20) was measured from blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 minute (min) prior to treatment, every 3 min from min 0 through 60, and every 15 min from min 60 through 120 during the clamp. Means were calculated using analysis of variance with fixed effects of participant, sequence within participant, treatment, and period.|Predose and up to 120 minutes postdose during Stage 1 or Stage 2|Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable AUC(GIR[0-120]) data.||Grams per kilogram||Standard Deviation|Mean
768800|NCT00705536|Secondary|Area Under the Glucose Infusion Rate Curve From 0 to 60 Minutes After Injection (AUC[GIR{0-60}])|The area under the curve for the glucose infusion rate from minutes (min) 0 to 60 after injection (AUC[GIR{0-60}]) for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase (rHuPH20) was measured from blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 min prior to treatment and every 3 min from min 0 through 60 during the clamp procedure. Means were calculated using analysis of variance with fixed of participant, sequence within participant, treatment, and period.|Predose and up to 60 minutes postdose during Stage 1 or Stage 2|Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable AUC(GIR[0-60]) data.||Grams per kilogram||Standard Deviation|Mean
768801|NCT00705536|Secondary|Maximum Glucose Infusion Rate (GIR[Max])|Maximum glucose infusion rate (GIR[max]) for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase PH20 (rHuPH20) were measured from blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 minute (min) prior to treatment, every 3 min from min 0 through 60, every 15 min from min 60 through 180, and every 60 min from min 180 through 360 throughout the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period.|Predose and up to 360 minutes postdose during Stage 1 or Stage 2|Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable GIR(max) data.||Milligrams per kilogram per minute||Standard Deviation|Mean
768802|NCT00705536|Primary|Relative Bioavailability (Area Under the Curve [AUC] for Insulin + Recombinant Human Hyaluronidase [rHuPH20] / AUC for Insulin Alone)|"Relative bioavailability was determined by dividing the baseline-corrected geometric mean of the area under the curve (AUC) for insulin (ins) (Humalog or Humulin-R) with recombinant human hyaluronidase PH20 (rHuPH20) by the baseline-corrected geometric mean of the AUC for insulin alone (AUC[insulin+rHuPH20]/AUC[insulin]).
Bioavailability values for participants who received Humalog or Humulin-R and rHuPH20 were measured from blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 minute (min) prior to treatment, every 3 min from min 0 through 60, every 15 min from min 60 through 180, and every 60 min from min 180 through 360 throughout the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period."|Predose and up to 360 minutes postdose during Stage 1 or Stage 2|Participants who received at least 1 dose of Humalog + rHuPH20 or Humulin-R + rHuPH20 with evaluable relative bioavailability (AUC[insulin+rHuPH20]/AUC[insulin alone]) data.||Ratio of AUC(ins+rHuPH20)/AUC(ins alone)||Standard Deviation|Mean
768803|NCT00705536|Primary|Area Under the Concentration-Time Curve From Time 0 to Time to Reach Maximum Concentration (Tmax) for Serum Insulin With Recombinant Human Hyaluronidase PH20 (rHuPH20) (AUC[0-tmaxPH20])|Area under the concentration-time curve from time 0 to time to reach maximum concentration (tmax) for serum insulin (Humalog or Humulin-R) with recombinant human hyaluronidase (rHuPH20) (AUC[0-tmaxPH20]) for participants who received Humalog or Humulin-R and with rHuPH20 were measured from blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 minute (min) prior to treatment and every 3 min from min 0 through 48 for Stage 1 and, and every 3 min from min 0 through 68 for Stage 2 during the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period.|Predose and up to 48 minutes postdose during Stage 1, or up to 68 minutes postdose during Stage 2|Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable AUC(0-tmaxPH20) data.||Picomoles per liter times minutes||Standard Deviation|Mean
768804|NCT00705536|Primary|Area Under the Serum Concentration-Time Curve From Time Zero to the Time Required to Reach Endogenous Plasma Glucose Levels (AUC[0-t'])|Area under the serum concentration-time curve from time zero to the time required to reach endogenous plasma glucose levels (AUC[0-t']) for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase PH20 (rHuPH20) were measured from 3 milliliter (mL) blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 minute (min) prior to treatment, every 3 min from min 0 through 60, every 15 min from min 60 through 180, and every 60 min from min 180 through 360 throughout the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period.|Predose and up to 360 minutes postdose during Stage 1 or Stage 2|Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable AUC(0-t') data.||Picomoles per liter times minutes||Standard Deviation|Mean
768805|NCT00705536|Secondary|Time to Late Half-Maximal Effect for Glucose Infusion Rate (tGIR[late50%])|"Time to late half-maximal effect for glucose infusion rate (tGIR[late50%]) for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase (rHuPH20) were measured from blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 minute (min) prior to treatment, every 3 min from min 0 through 60, every 15 min from min 60 through 180, and every 60 min from min 180 through 360 throughout the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period.
Because the study was only 360 minutes in duration, there was not sufficient time for regular human insulin to show an effect and therefore tGIR(late50%) could not be calculated for participants receiving Humulin-R alone."|Predose and up to 360 minutes postdose during Stage 1 or Stage 2|Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, or Humulin-R + rHuPH20 with evaluable tGIR(late50%) data.||Minutes||Standard Deviation|Mean
768861|NCT00708071|Secondary|Participants With Hematoma/Seroma During the Study|Investigators assessed each side of the face for the presence of hematoma/seroma|Through Postoperative Day 14 (± 1)|Per protocol||participants|||Number
768806|NCT00705536|Secondary|Time to Early Half-Maximal Effect for Glucose Infusion Rate (tGIR[early50%])|Time to early half-maximal effect for glucose infusion rate (tGIR[early50%]) for participants who were randomized to Humalog or Humulin-R with or without recombinant human hyaluronidase PH20 (rHuPH20) were measured from blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 minute (min) prior to treatment, every 3 min from min 0 through 60, every 15 min from min 60 through 180, and every 60 min from min 180 through 360 throughout the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period.|Predose and up to 360 minutes postdose during Stage 1 or Stage 2|Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable tGIR(early50%) data.||Minutes||Standard Deviation|Mean
768807|NCT00705536|Secondary|Time to Maximum Glucose Infusion Rate (tGIR[Max])|Time to maximal effect for glucose infusion rate (tGIR[max]) for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase PH20 (rHuPH20) were measured from blood samples obtained every 3 minutes during a euglycemic clamp procedure. Samples were taken 10 and 1 minute (min) prior to treatment, every 3 min from min 0 through 60, every 15 min from min 60 through 180, and every 60 min from min 180 through 360 throughout the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period.|Predose and up to 360 minutes postdose during Stage 1 or Stage 2|Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable tGIR(max) data.||Minutes||Standard Deviation|Mean
768808|NCT00705536|Primary|Maximum Serum Insulin Concentration (Cmax)|Maximum serum insulin concentration (Cmax) values for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase PH20 (rHuPH20) were measured from 3 milliliter (mL) blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 minute (min) prior to treatment, every 3 min from min 0 through 60, every 15 min from min 60 through 180, and every 60 min from min 180 through 360 throughout the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period.|Predose and up to 360 minutes postdose during Stage 1 or Stage 2|Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable Cmax data.||Picomoles per liter||Standard Deviation|Mean
768809|NCT00705536|Primary|Time to Maximum Serum Insulin Concentration (Tmax)|Time to maximum serum insulin concentration (tmax) values for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase PH20 (rHuPH20) were measured from 3 milliliter (mL) blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 minute (min) prior to treatment, every 3 min from min 0 through 60, every 15 min from min 60 through 180, and every 60 min from min 180 through 360 throughout the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period.|Predose and up to 360 minutes postdose during Stage 1 or Stage 2|Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable tmax data.||Minutes||Standard Deviation|Mean
768810|NCT00705575|Secondary|Percentage of Patients Achieving the Target Blood Pressure (msSBP < 140 mm Hg and msDBP < 90 mm Hg, and msSBP < 130 mm Hg and msDBP < 80 mm Hg for Diabetics) at Week 8 and Week 12|At the first visit, blood pressure (BP) was measured in both arms and the arm having the higher BP reading was the arm used for all subsequent readings throughout the study. Patients were required to sit for five minutes with feet flat on the floor, with arm resting so that the bottom of the cuff was at the same level as the heart. BP was measured three times at 1 to 2-minute intervals at each visit using the correct cuff size. The mean BP was calculated from the 3 readings.|Baseline to Week 12|Full analysis set (FAS): All randomized patients. For each patient, the last post-baseline measurement during the double-blind period was carried forward. n = number of patients with non-missing Week 8 or Week 12 measurement or last observation carried forward (LOCF) value.||Percentage|||Number
768811|NCT00705575|Secondary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to Week 8 and to Week 12|At the first visit, blood pressure (BP) was measured in both arms and the arm having the higher BP reading was the arm used for all subsequent readings throughout the study. Patients were required to sit for five minutes with feet flat on the floor, with arm resting so that the bottom of the cuff was at the same level as the heart. BP was measured three times at 1 to 2-minute intervals at each visit using the correct cuff size. The mean BP was calculated from the 3 readings.|Baseline to Week 12|Full analysis set (FAS): All randomized patients. For each patient, the last post-baseline measurement during the double-blind period was carried forward. n = number of patients with non-missing Week 8 or Week 12 measurement or last observation carried forward (LOCF) value.||mm Hg||Standard Error|Least Squares Mean
768812|NCT00705575|Secondary|Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to Week 8|At the first visit, blood pressure (BP) was measured in both arms and the arm having the higher BP reading was the arm used for all subsequent readings throughout the study. Patients were required to sit for five minutes with feet flat on the floor, with arm resting so that the bottom of the cuff was at the same level as the heart. BP was measured three times at 1 to 2-minute intervals at each visit using the correct cuff size. The mean BP was calculated from the 3 readings.|Baseline to Week 8|Full analysis set (FAS): All randomized patients. For each patient, the last post-baseline measurement during the double-blind period was carried forward. n = number of patients with non-missing Week 8 measurement or last observation carried forward (LOCF) value.||mm Hg||Standard Error|Least Squares Mean
768813|NCT00705575|Primary|Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 12)|At the first visit, blood pressure (BP) was measured in both arms and the arm having the higher BP reading was the arm used for all subsequent readings throughout the study. Patients were required to sit for five minutes with feet flat on the floor, with arm resting so that the bottom of the cuff was at the same level as the heart. BP was measured three times at 1 to 2-minute intervals at each visit using the correct cuff size. The mean BP was calculated from the 3 readings.|Baseline to end of study (Week 12)|Full analysis set (FAS): All randomized patients. For each patient, the last post-baseline measurement during the double-blind period was carried forward. n = number of patients with non-missing Week 12 measurement or last observation carried forward (LOCF) value.||mm Hg||Standard Error|Least Squares Mean
768862|NCT00708071|Secondary|Participants With Hematoma/Seroma|Investigators assessed each side of the face for the presence of hematoma/seroma|Days 0, 1, 3, 5, 7,10, and 14|Per Protocol||Participants|||Number
768814|NCT00705614|Secondary|Number of Participant Surgical Procedures for Crohn's Disease in the Prior 6 Months|The number of participants undergoing surgical procedures for Crohn's Disease in the prior 6 months was evaluated at each study visit.|Up to 5 Years|The population consisted of all enrolled participants with surgical procedure data. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.||Surgical Procedures|||Number
768815|NCT00705614|Secondary|Duration of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months|The duration of hospital stays for Crohn's Disease in the prior 6 months was evaluated at each study visit.|Up to 5 Years|The population consisted of all enrolled participants with hospital stay duration data. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.||Days||Standard Deviation|Mean
768816|NCT00705614|Secondary|Number of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months|The number of participant hospital stays for Crohn's Disease in the prior 6 months was evaluated at each study visit.|Up to 5 Years|The population consisted of all enrolled participants with hospital stay data. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.||Hospital Stays||Standard Deviation|Mean
768817|NCT00705614|Secondary|Number of Participants With a Draining Fistula By Study Visit|The number of participants with a draining fistula was evaluated at each study visit.|Up to 5 Years|The population consisted of all enrolled participants with fistula status data. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.||Participants|||Number
768818|NCT00705614|Secondary|Work/Daily Activity Status Score By Study Visit|The participant work/daily activity status score was evaluated at each study visit. The work/daily activity questionnaire asked participants to rate their level of daily functioning on a scale of 1 to 10 with a lower score indicating less of an impact of Crohn's disease on work or daily life functioning.|Up to 5 Years|The population consisted of all participants with a work/daily activity status score at baseline and each study visit. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.||Score on a Scale||Standard Deviation|Mean
768819|NCT00705614|Secondary|The Harvey-Bradshaw Index of Crohn's Disease Activity By Study Visit|The Harvey-Bradshaw Index of Crohn's Disease Acitivity was evaluated at each study visit. The Harvey-Bradshaw Index evaluates participants' general health in the day prior in the domains of well being, abdominal pain, number of liquid stools per day, and abdominal mass and complications and was evaluated on the day of the study visit. The score is derived from a 0-4 score for general well being, 0-3 for abdmonial pain, raw score for number of liquid stools per day, 0-3 for abdominal mass, and raw score for complications. The total score is from 0 to infinity, with lower scores indicating better outcomes.|Up to 5 Years|The population consisted of all enrolled participants with a Harvey-Bradshaw Index of Crohn's Disease score at baseline and each time point. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.||Score on a Scale||Standard Deviation|Mean
768820|NCT00705614|Secondary|Participant Assessment of Overall Health Status By Study Visit|The participant assessment of overall health status was evaluated at baseline and each study visit. The overall health status questionnaire asked participants to rate their current health status over the prior 24 hours as 1=best possible, 2=much better than average, 3=better than average, 4=average, 5=worse than average, 6=much worse than average, or 7=worst possible. Scores ranged from 1 to 7 with lower scores indicating better health status.|Up to 5 Years|The population consisted of all enrolled participants with a Participant Assessment of Overall Health Index score at baseline and each time point. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.||Score on a Scale||Standard Deviation|Mean
768821|NCT00705614|Primary|Number of Participants With Lymphoproliferative Disorders/Malignancies|The number of participants wtih lymphoproliferative disorders and/or malignancies was evaluated. A lymphoproliferative disorder and /or malignancy included, but was not limited to, lymphoma, gastrointestinal cancer, skin cancer (including basocellular and squamous carcinoma, melanoma) and in situ cervical carcinoma.|Up to 5 Years|The population consisted of all enrolled participants. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.||Participants|||Number
768822|NCT00705614|Primary|Number of Participants With Hematologic Conditions|The number of participants wtih hematologic conditions was evaluated. A hematologic condition was defined as thrombocytopenia, neutropenia, pancytopenia, granulocytopenia, leukopenia, or aplastic anemia.|Up to 5 Years|The population consisted of all enrolled participants. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.||Participants|||Number
768823|NCT00705614|Primary|Number of Participants With Demyelinating Neurological Disorders|The number of participants with demyelinating neurological disorders was evaluated. Demyelinating neurological disorders were defined as multiple sclerosis, optic neuritis, peripheral syndromes such as peripheral neuropathy, mononeuropathy multipex, cranial neuropathies, Guillain-Barré syndrome, chronic inflammatory demyelinating polyradiculoneuropathy, and transverse myelitis.|Up to 5 Years|The population consisted of all enrolled participants. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.||Participants|||Number
768824|NCT00705614|Primary|Number of Participants With New or Worsening Congestive Heart Failure|The number of participants with new or worsening congestive heart failure was evaluated throughout the study.|Up to 5 Years|The population consisted of all enrolled participants. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.||Participants|||Number
768863|NCT00708071|Secondary|Total Volume of Drainage on Each Side of the Face||24 hours postoperative|Per Protocol||mL||Full Range|Median
769578|NCT00706004|Secondary|Serum Phosphate||baseline and 4 weeks|Participants who completed the study||mg/dL||Standard Deviation|Mean
768826|NCT00705614|Primary|Number of Participants With Infusion-Related Reactions/Hypersensitivity|The number of participants with infusion-related reactions and/or hypersensitivity was evaluated. An infuson-related reaction/hypersensitivity was defined as as an acute reaction, including anaphylactic shock that occurs after the onset of the infusion or within the 1- to 2-hour observation period following the end of the infusion. Delayed hypersensitivity reactions (myalgia and/or arthralgia with fever and rash within 14 days of the infusion) were included.|Up to 5 Years|The population consisted of all enrolled participants. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.||Participants|||Number
768827|NCT00705614|Primary|Number of Participants With Serious Infections|The number of participants experiencing serious infections was evaluated. Serious infections included, but were not limited to, tuberculosis, opportunistic infections (such as Pneumocystis carinii [PCP] pneumonia, listeriosis, atypical mycobacteria, and histoplasmosis), salmonellosis,and serious viral infections.|Up to 5 Years|The population consisted of all enrolled participants. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.||Participants|||Number
768828|NCT00705653|Primary|Maximum Tolerated Dose (MTD)|"The MTD was defined as the dose below one-third of at least 6 subjects (e.g., 2/6, 3/9, 4/12) experienced a Dose-limiting toxicity (DLT).
Dose-limiting toxicities (DLTs) used to determine the MTD had to occur during cycle 1 of treatment and had to be considered related to PG-11047."|The MTD had to occur during cycle 1 of treatment|||mg|||Number
768829|NCT00705653|Secondary|Preliminary Efficacy|As per RECIST Criteria (V 1.0) by radiologic evaluations: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR) >= 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD), >= 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|For the purposes of this study, patients were reevaluated radiologically every 8 weeks. In addition to a baseline scan, confirmatory scans were obtained 6-8 weeks following initial documentation of an objective response, when appropriate.|Patients with non-missing overall response||percentage (of participants)|||Number
768830|NCT00705666|Primary|The Number of Participants Receiving the Recommended Treatment Duration (24 Weeks for Genotypes 2 and 3 and 48 Weeks for Genotype 1 According to the French 2002 Consensus Meeting).||Physicians will complete a questionnaire at these visits: treatment initiation; 12 and 24 weeks after treatment initiation and 24 weeks after the end of treatment; and 36 and 48 weeks after treatment initiation for participants treated for 48 weeks.|For the 48 week treatment period, the analysis did not separate Genotype 1 (G1) from Genotype 4 (G4) or others. Of the 789 participants, 8 were excluded from analysis (3 for lack of data; 5 because they were untreated).||Participants|||Number
768831|NCT00705679|Primary|Extended Safety of Daily Tenofovir 1% Gel, Oral TDF, and Oral FTC/TDF in Women at Risk for Sexually Transmitted HIV Infection Based on Occurrence of Grade 2, 3, and 4 Adverse Events|This measure describes the number of participants with elevated serum creatinine levels, the only safety outcome of concern where a significant difference was detected between an active arm and the corresponding placebo arm.|Throughout study, up to 2.5 years|All participants randomized (intention-to-treat).||participants|||Number
768832|NCT00705679|Primary|Incidence Rate of HIV-1 Infections of Oral TDF-FTC and Oral Placebo Arms|This is the number of HIV-1 infections divided by the amount of person-years of follow-up time to HIV-1 infection status, multiplied by 100 (per 100 person-years).|For up to 30 months of follow-up|All participants randomized except for those with no follow-up HIV testing or those determined to be HIV-positive at the time of randomization by PCR testing of plasma samples stored at the enrollment visit.||cases per 100 person-years||95% Confidence Interval|Number
768833|NCT00705679|Primary|Number of HIV-1 Infections of Oral TDF-FTC and Oral Placebo Arms|Participants were followed for up to 30 months. Participants were tested monthly for HIV-1 and positive rapid test results were confirmed by means of an enzyme-linked immunosorbent assay (EIA) and subsequent Western blotting (WB).|For up to 30 months of follow-up|All participants randomized except for those with no follow-up HIV testing or those determined to be HIV-positive at the time of randomization by PCR testing of plasma samples stored at the enrollment visit.||participants|||Number
768834|NCT00705679|Primary|Person-years of Follow-up of Oral TDF-FTC and Oral Placebo Arms|Participants were followed for up to 30 months. Person-years measures the amount of time for each participant, in years, from the date of enrollment to the date of the first HIV-positive test result if HIV-infected during follow-up or to the date of the last HIV-negative test result on follow-up if not HIV-infected during follow-up.|For up to 30 months of follow-up|All participants randomized except for those with no follow-up HIV testing or those determined to be HIV-positive at the time of randomization by PCR testing of plasma samples stored at the enrollment visit.||person-years|||Number
768835|NCT00705679|Primary|Incidence Rate of HIV-1 Infections of Oral TDF and Oral Placebo Arms|This is the number of HIV-1 infections divided by the amount of person-years of follow-up time to HIV-1 infection status, multiplied by 100 (per 100 person-years).|For up to 30 months of follow-up|All participants randomized except for those with no follow-up HIV testing or those determined to be HIV-positive at the time of randomization by PCR testing of plasma samples stored at the enrollment visit.||cases per 100 person-years||95% Confidence Interval|Number
768836|NCT00705679|Primary|Number of HIV-1 Infections of Oral TDF and Oral Placebo Arms|Participants were followed for up to 30 months. Participants were tested monthly for HIV-1 and positive rapid test results were confirmed by means of an enzyme-linked immunosorbent assay (EIA) and subsequent Western blotting (WB).|For up to 30 months of follow-up|All participants randomized except for those with no follow-up HIV testing or those determined to be HIV-positive at the time of randomization by PCR testing of plasma samples stored at the enrollment visit.||participants|||Number
768864|NCT00708071|Secondary|Resolution of Edema as Assessed by Investigators.|Resolution of edema (grade 1 on the Marchac Scale for Edema (Grade 1 = Nil)|Postoperative Days 1, 3, 5, 7, 10, and 14|Per Protocol||participants|||Number
768865|NCT00708071|Secondary|Resolution of Ecchymosis as Assessed by Investigators|Resolution of ecchymosis (grade 0 on the Modified Marchac Scale for ecchymosis (Grade 0 = No bruising at all))|Postoperative Days 1, 3, 5, 7, 10, and 14|Per Protocol||participants|||Number
768837|NCT00705679|Primary|Person-years of Follow-up of Oral TDF and Oral Placebo Arms|Participants were followed for up to 30 months. Person-years measures the amount of time for each participant, in years, from the date of enrollment to the date of the first HIV-positive test result if HIV-infected during follow-up or to the date of the last HIV-negative test result on follow-up if not HIV-infected during follow-up. Note that the data for both of these arms were censored on the date when sites were asked to discontinue treatment in the oral TDF group.|For up to 30 months of follow-up|All participants randomized except for those with no follow-up HIV testing or those determined to be HIV-positive at the time of randomization by PCR testing of plasma samples stored at the enrollment visit.||person-years|||Number
768838|NCT00705679|Primary|Incidence Rate of HIV-1 Infections of Tenofovir 1% Gel and Vaginal Placebo Gel Arms|This is the number of HIV-1 infections divided by the amount of person-years of follow-up time to HIV-1 infection status, multiplied by 100 (per 100 person-years).|For up to 30 months of follow-up|All participants randomized except for those with no follow-up HIV testing or those determined to be HIV-positive at the time of randomization by PCR testing of plasma samples stored at the enrollment visit.||cases per 100 person-years||95% Confidence Interval|Number
768839|NCT00705679|Secondary|Frequency of HIV-1 Drug Resistance in Women Who Acquire HIV-1 Infection While Using Study Product|The primary resistance mutations for the study were pre-defined as K65R and K70E (which confer resistance to TDF), and M184I and M184V (which confer resistance to FTC), for their potential to cause a decrease in susceptibility to the study drug. K65R, K70E, and M184I were not detected in HIV-1 from any HIV-1 seroconverters while on study product. The number of HIV-1 seroconverters while on study with the M184V resistance mutation are reported for this outcome measure.|Throughout study, up to 2.5 years|Resistance testing was successfully completed on plasma from 301/312 HIV-1 seroconverters while on study product. 11 participants did not have a resistance result due to no stored plasma, insufficient copies of HIV-1 RNA for extraction, or PCR amplification failure.||participants|||Number
768840|NCT00705679|Primary|Number of HIV-1 Infections of Tenofovir 1% Gel and Vaginal Placebo Gel Arms|Participants were followed for up to 30 months. Participants were tested monthly for HIV-1 and positive rapid test results were confirmed by means of an enzyme-linked immunosorbent assay (EIA) and subsequent Western blotting (WB).|For up to 30 months of follow-up|All participants randomized except for those with no follow-up HIV testing or those determined to be HIV-positive at the time of randomization by PCR testing of plasma samples stored at the enrollment visit.||participants|||Number
768841|NCT00705679|Primary|Person-years of Follow-up of Tenofovir 1% Gel and Vaginal Placebo Gel Arms|Participants were followed for up to 30 months. Person-years measures the amount of time for each participant, in years, from the date of enrollment to the date of the first HIV-positive test result if HIV-infected during follow-up or to the date of the last HIV-negative test result on follow-up if not HIV-infected during follow-up.|For up to 30 months of follow-up|All participants randomized except for those with no follow-up HIV testing or those determined to be HIV-positive at the time of randomization by PCR testing of plasma samples stored at the enrollment visit.||person-years|||Number
768842|NCT00705718|Secondary|Secondary Endpoint - Effectiveness Evaluation|"The following secondary endpoints were included in the pivotal trial to evaluate the effectiveness profile of the Endurant Stent Graft System.
Stent Graft migration through 12 months
Stent Graft Patency through 12 months
All stent Graft Endoleaks at 1-month, 6-months, and 12-month
Secondary Procedures to correct Type I and type III Endoleaks through 12 months
Secondary Endovascular Procedures through 12 months
Technical Observations through 12 months"|12 months|Number of subjects enrolled in the study arm||percentage of evaluable subjects|||Number
768843|NCT00705718|Primary|Primary Effectiveness Endpoint (Treatment Success)|"Treatment success is defined as Technical success and the following:
Freedom from AAA diameter increased, defined as >5 mm increase in maximum diameter as measured on CT scan (or MRA/MRI) at 12 months as compared to 1 month
Freedom from Types I and III endoleaks at 12 months including those requiring intervention through 12 months
Freedom from aneurysm rupture through 12 months
Freedom from conversion to surgery through 12 months
Freedom from stent graft migrations resulting in a serious adverse event or requiring secondary intervention through 12 months
Freedom from stent graft occlusion at 12 months"|12 months|The number of evaluable subjects for ths endpoint.||participants|||Number
768844|NCT00705718|Primary|Primary Effectiveness Endpoint (Technical Success)|Technical success defined as successful delivery and deployment of the stent graft in the planned location and with no unintentional coverage of both the internal iliac arteries or any visceral aortic branches and with removal of the system. Technical success was assessed intra-operatively.|Intra-operatively|The Technical Success of the Endurant Bifurcated arm was based on obtaining information for the first 121 evaluable subjects available in the clinical study.||participants|||Number
768845|NCT00705718|Secondary|Secondary Endpoints - Safety Evaluation|"The following secondary endpoints were included in the Pivotal trial to evaluate the safety profile of the Endurant Stent Graft System.
Aneurysm-Related Mortality through 12 months
All-Cause Mortality with 30 days
All-Cause Mortality within 12 months
Major Adverse Events through 12 months
Adverse Events through 12 months
Unanticipated Adverse Device Events
Serious Adverse Events (SAEs) As reported at the time of the data cut off.
Device Related Adverse Events
Procedure Related Adverse Events
Adverse Events (excluding SAEs)"|12 months|Number of subjects enrolled in the study arm||percentage of evaluable participants|||Number
768846|NCT00705718|Primary|Major Adverse Events Within 30 Days of Index Procedure|"The primary safety endpoint is composite defined as the proportion of subjects free from major adverse events (MAE) within 1 month (day 0 - Day 30)of implant is non-inferior to the proportion of subjects free from MAEs in the Talent Control Group. The endpoint is defined as the proportion of subjects free from occurence of a MAE within 1 month of the implantation of the Endurant Stent Graft. The major adverse events composite endpoint which will be evaluated at 1 month post implant includes the occurrence of any of the following events.
All-Cause Mortality
Bowel Ischemia
Myocardial Infarction
Paraplegia
Procedural Blood Loss > or equal to 1000 cc
Renal Failure
Respiratory Failure
Stroke"|30 days|||percentage of participants|||Number
768885|NCT00708071|Secondary|Visual Comparison of Ecchymosis at Day 14|Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs.|Through Postoperative Day 14|Per Protocol. If there is no majority (i.e., 3 or more in agreement) in the outcomes of the visual comparison of both sides of the face from the 5 blinded reviewers then the assessment will not contribute to the analysis.||participants|||Number
768847|NCT00705718|Primary|Primary Safety Endpoint (Freedom From MAEs Within 30 Days of Index Procedure)|"The primary safety endpoint is composite defined as the proportion of subjects free from major adverse events (MAE) within 1 month (day 0 - Day 30)of implant is non-inferior to the proportion of subjects free from MAEs in the Talent Control Group. The endpoint is defined as the proportion of subjects free from occurence of a MAE within 1 month of the implantation of the Endurant Stent Graft. The major adverse events composite endpoint which will be evaluated at 1 month post implant includes the occurrence of any of the following events.
All-Cause Mortality
Bowel Ischemia
Myocardial Infarction
Paraplegia
Procedural Blood Loss > or equal to 1000 cc
Renal Failure
Respiratory Failure
Stroke"|30 days (Safety)|Freedom from Major Adverse Events within 30 Days of Implant||percentage of participants|||Number
768848|NCT00705757|Primary|The Extent of Latanoprost, Bimatoprost and Travoprost Induced Periocular Skin Hyperpigmentation Over a One Year Time Course in Newly Diagnosed Primary Open Angle and Ocular Hypertension Patients.|"Periocular skin color was measured with the Minolta Chroma Meter CR-400 and the L*a*b* system, also known as Commission Internationale de l'Eclairage. This is a well-accepted unit of measurement in which L* corresponds to brightness and a* and b* correspond to chromaticity.
Measurements were taken at baseline and 1 year. Data from each time point and each location (upper and lower eyelids or cheeks/face) were averaged, and subtracted from the baseline value for that location. Six predetermined areas on and around the upper and lower eyelid and 2 areas of the face/cheek were measured.Upper and lower eyelid values were averaged and reported as single value for each location ie;-upper eyelids, lower eyelid and cheek/face. A decrease in luminance indicates increased pigmentation at the site of measurement."|one year|Newly diagnosed glaucoma and ocular hypertension, males and females, age 30 and up, Caucasians and African Americans.||L*a*b*||Standard Error|Mean
768849|NCT00708019|Secondary|Worst Pain Intensity Score|"Worst pain was measured using a 0 (no pain) to 10 (worst pain imaginable) numeric rating scale on a daily basis.
Change in worst pain intensity between the two intervention groups was evaluated from enrollment to the end of the study (i.e., 10 weeks)."|10 weeks|||units on a scale||95% Confidence Interval|Mean
768850|NCT00708019|Primary|Average Pain Intensity Score|"Average pain was measured using a 0 (no pain) to 10 (worst pain imaginable) numeric rating scale on a daily basis.
Change in average pain intensity between the two intervention groups was evaluated from enrollment to the end of the study (i.e., 10 weeks)."|10 weeks|||units on a scale||95% Confidence Interval|Mean
768851|NCT00708032|Primary|Papillary Conjunctivitis|Papillary conjunctivitis which is collected as part of the biomicroscopy data and is identified from a slit lamp examination. Grade 0 to Grade 4 with grade 0 implying no health concerns.|12 months|Subjects analyzed were those who were enrolled, randomized to a study arm, and completed the study.||units on a scale||Standard Deviation|Mean
768852|NCT00708032|Secondary|Subjective Overall Vision After 12 Months of Daily Wear|subject response using a scale of 0 to 100, where 0 = poor vision, 100 = excellent vision|at 12 months|Subjects analyzed were those who were enrolled, randomized to a study arm, and completed the study.||units on a scale||Standard Deviation|Mean
768853|NCT00708032|Secondary|Subjective Overall Comfort After 12 Months of Daily Wear|subject response using a scale of 0 to 100, where 0 = poor comfort, 100 = excellent comfort|at 12 months|Subjects analyzed were those who were enrolled, randomized to a study arm, and completed the study.||units on a scale||Standard Deviation|Mean
768854|NCT00708032|Secondary|Visual Acuity After 12 Months of Wear|Visual acuity is measured at high and low contrasts, via the Snellen scale which is then mathematically converted to logMar units. High contrast refers to a darker print on the Snellen chart and is an easier testing environment compared to the low contrast which has a grayer print.|at 12 months|Subjects analyzed were those who were enrolled, randomized to a study arm, and completed the study.||logMar||Standard Deviation|Mean
768855|NCT00708032|Secondary|Biomicroscopy Findings After 12 Months of Daily Wear From Slit Lamp Analysis.|Comprised of 8 categories (conjunctival hyperemia, limbal hyperemia, corneal vascularization, microcysts, Oedema, corneal staining, conjunctival staining and papillary conjunctivitis) each scored on a scale of 0 to 4 where 0=none, and 4=maximum score for each category.|at 12 months|Subjects analyzed were those who were enrolled, randomized to a study arm, and completed the study.||units on a scale||Standard Deviation|Mean
768856|NCT00708071|Primary|Incidence of Adverse Events (AEs) Related to Study Product (FS VH S/D 4) Throughout the Study Period||Through Postoperative Day 14 (± 1)|Safety Data Set||Adverse Events|||Number
768857|NCT00708071|Secondary|Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4)|Participants compared the levels of bruising on each side of their face and determine if they had a preference for the look of 1 side over another.|Postoperative Days 1, 3, 5, 7, 10, and 14|Per Protocol||participants|||Number
768858|NCT00708071|Secondary|Differences in Subjects' Assessments of Numbness for Each Side of Face (SoC and FS VH S/D 4)|"Differences are calculated as (Grade for SoC) - (Grade for FS VH S/D 4). Participants used a 10-point visual analogue scale to complete a numbness assessment for each side of their face during each postoperative study visit (Days 1, 3, 5, 7, 10, and 14). The higher the number, the greater the numbness experienced, i.e. 10 = worst, 1 = least.
The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Days 1, 3, 5, 7,10, and 14|Per Protocol||Scores on a scale||Full Range|Median
768859|NCT00708071|Secondary|Differences in Subjects' Assessments of Pain for Each Side of Face (SoC and FS VH S/D 4)|"Differences are calculated as (Grade for SoC) - (Grade for FS VH S/D 4). Participants used a 10-point visual analogue scale to complete a pain assessment for each side of their face during each postoperative study visit (Days 1, 3, 5, 7, 10, and 14). The higher the number, the greater the pain experienced, i.e. 10 = worst, 1 = least.
The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Days 1, 3, 5, 7,10, and 14|Per Protocol||Scores on a scale||Full Range|Median
768968|NCT00708214|Secondary|Duration of Confirmed OR|Duration of confirmed OR is measured from the time of first OR to the time of progression or death (or date of censoring for progression free survival).|First occurence or OR till progression or death|TS. Median duration of RECIST tumour response was not calculable as there was no OR observed.||days||95% Confidence Interval|Median
768866|NCT00708071|Secondary|Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 14|"Investigators used MMS during examinations- postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color & affects limited area); Grade 2= Present, minimal (yellow color & covers ≤25% of operated area); Grade 3= Moderate (yellow color & covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color & covers more than just very small area, dark purple color)
The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 14|Per Protocol||Scores on a scale||90% Confidence Interval|Median
768867|NCT00708071|Secondary|Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 10|"Investigators used MMS during examinations- postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color & affects limited area); Grade 2= Present, minimal (yellow color & covers ≤25% of operated area); Grade 3= Moderate (yellow color & covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color & covers more than just very small area, dark purple color)
The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 10|Per Protocol||Scores on a scale||90% Confidence Interval|Median
768868|NCT00708071|Secondary|Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 7|"Investigators used MMS during examinations- postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color & affects limited area); Grade 2= Present, minimal (yellow color & covers ≤25% of operated area); Grade 3= Moderate (yellow color & covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color & covers more than just very small area, dark purple color)
The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 7|Per Protocol||Scores on a scale||90% Confidence Interval|Median
768869|NCT00708071|Secondary|Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 5|"Investigators used MMS during examinations- postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color & affects limited area); Grade 2= Present, minimal (yellow color & covers ≤25% of operated area); Grade 3= Moderate (yellow color & covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color & covers more than just very small area, dark purple color)
The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 5|Per Protocol||Scores on a scale||90% Confidence Interval|Median
768870|NCT00708071|Secondary|Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 3|"Investigators used MMS during examinations- postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color & affects limited area); Grade 2= Present, minimal (yellow color & covers ≤25% of operated area); Grade 3= Moderate (yellow color & covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color & covers more than just very small area, dark purple color)
The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 3|Per Protocol||Scores on a scale||90% Confidence Interval|Median
768871|NCT00708071|Secondary|Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 1|"Investigators used MMS during examinations- postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color & affects limited area); Grade 2= Present, minimal (yellow color & covers ≤25% of operated area); Grade 3= Moderate (yellow color & covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color & covers more than just very small area, dark purple color)
The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 1|Per Protocol||Scores on a scale||90% Confidence Interval|Median
768939|NCT00708162|Secondary|Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 400 Copies/mL at Week 48|The percentage of participants achieving and maintaining confirmed HIV-1 RNA < 400 copies/mL at Week 48 was analyzed using the FDA-defined TLOVR algorithm, which takes into account a patient's longitudinal viral load up to the predefined time point by considering patterns of suppression and rebounding.|Week 48|ITT Analysis Set||percentage of participants|||Number
768872|NCT00708071|Secondary|Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 14|"Investigators used the modified Marchac grading to evaluate edema during participant examinations on postoperative Day 1, 3, 5, 7, 10, and 14. The evaluations were performed on both sides of the face. Differences are calculated as Grade for Standard of Care - Grade for FS VH S/D 4. Marchac Scale for Post Rhytidectomy (Facelift) Edema: Grade 1= Nil; Grade 2= Minor; Grade 3= Moderate; Grade 4= Marked/unusual amount.
The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 14|Per Protocol||Scores on a scale||90% Confidence Interval|Median
768873|NCT00708071|Secondary|Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 10|"Investigators used the modified Marchac grading to evaluate edema during participant examinations on postoperative Day 1, 3, 5, 7, 10, and 14. The evaluations were performed on both sides of the face. Differences are calculated as Grade for Standard of Care - Grade for FS VH S/D 4. Marchac Scale for Post Rhytidectomy (Facelift) Edema: Grade 1= Nil; Grade 2= Minor; Grade 3= Moderate; Grade 4= Marked/unusual amount.
The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 10|Per Protocol||Scores on a scale||90% Confidence Interval|Median
768874|NCT00708071|Secondary|Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 7|"Investigators used the modified Marchac grading to evaluate edema during participant examinations on postoperative Day 1, 3, 5, 7, 10, and 14. The evaluations were performed on both sides of the face. Differences are calculated as Grade for Standard of Care - Grade for FS VH S/D 4. Marchac Scale for Post Rhytidectomy (Facelift) Edema: Grade 1= Nil; Grade 2= Minor; Grade 3= Moderate; Grade 4= Marked/unusual amount.
The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 7|Per Protocol||Scores on a scale||90% Confidence Interval|Median
768875|NCT00708071|Secondary|Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 5|"Investigators used the modified Marchac grading to evaluate edema during participant examinations on postoperative Day 1, 3, 5, 7, 10, and 14. The evaluations were performed on both sides of the face. Differences are calculated as Grade for Standard of Care - Grade for FS VH S/D 4. Marchac Scale for Post Rhytidectomy (Facelift) Edema: Grade 1= Nil; Grade 2= Minor; Grade 3= Moderate; Grade 4= Marked/unusual amount.
The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 5|Per Protocol||Scores on a scale||90% Confidence Interval|Median
768876|NCT00708071|Secondary|Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 3|"Investigators used the modified Marchac grading to evaluate edema during participant examinations on postoperative Day 1, 3, 5, 7, 10, and 14. The evaluations were performed on both sides of the face. Differences are calculated as Grade for Standard of Care - Grade for FS VH S/D 4. Marchac Scale for Post Rhytidectomy (Facelift) Edema: Grade 1= Nil; Grade 2= Minor; Grade 3= Moderate; Grade 4= Marked/unusual amount.
The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 3|Per Protocol||Scores on a scale||90% Confidence Interval|Median
768877|NCT00708071|Secondary|Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 1|"Investigators used the modified Marchac grading to evaluate edema during participant examinations on postoperative Day 1, 3, 5, 7, 10, and 14. The evaluations were performed on both sides of the face. Differences are calculated as Grade for Standard of Care - Grade for FS VH S/D 4.
Marchac Scale for Post Rhytidectomy (Facelift) Edema: Grade 1= Nil, Grade 2= Minor, Grade 3= Moderate, Grade 4= Marked/unusual amount.
The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 1|Per Protocol||Scores on a scale||90% Confidence Interval|Median
768878|NCT00708071|Secondary|Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by a Blinded On-site Evaluator-Day 3|"Difference between each side of the face are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color)
The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Postoperative Day 3|Per Protocol||Scores on a scale||Full Range|Median
768886|NCT00708071|Secondary|Visual Comparison of Ecchymosis at Day 10|Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs.|Through Postoperative Day 10|Per Protocol. If there is no majority (i.e., 3 or more in agreement) in the outcomes of the visual comparison of both sides of the face from the 5 blinded reviewers then the assessment will not contribute to the analysis.||participants|||Number
769579|NCT00706004|Secondary|Serum Magnesium||baseline and 4 weeks|Participants who completed the study||mg/dL||Standard Deviation|Mean
768879|NCT00708071|Secondary|Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 14|"Reviewers used photographs from postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color)
The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 14|Per Protocol||Scores on a scale||90% Confidence Interval|Median
768880|NCT00708071|Secondary|Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 10|"Reviewers used photographs from postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color)
The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 10|Per Protocol||Scores on a scale||90% Confidence Interval|Median
768881|NCT00708071|Secondary|Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 7|"Reviewers used photographs from postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color)
The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 7|Per Protocol||Scores on a scale||90% Confidence Interval|Median
768882|NCT00708071|Secondary|Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 5|"Reviewers used photographs from postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color)
The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 5|Per Protocol||Scores on a scale||90% Confidence Interval|Median
768883|NCT00708071|Secondary|Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 3|"Reviewers used photographs from postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color)
The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 3|Per Protocol||Scores on a scale||90% Confidence Interval|Median
768884|NCT00708071|Secondary|Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 1|"Reviewers used photographs from postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color)
The planned and approved Statistical Analysis Plan (SAP) specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 1|Per Protocol||Scores on a scale||90% Confidence Interval|Median
768898|NCT00708110|Secondary|Mean Change From Baseline in Plasma HIV-1 RNA Levels During the Follow-up Period (Days 11 to 21)|Change from Baseline in Plasma HIV-1 RNA levels was calculated as the value during the Follow-up period minus the Basline value.|Baseline and Follow-up period (Days 11 to 21)|ITT(E) Population||Log10 copies/mL||Standard Deviation|Mean
768887|NCT00708071|Secondary|Visual Comparison of Ecchymosis at Day 7|Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs.|Through Postoperative Day 7|Per Protocol. If there is no majority (i.e., 3 or more in agreement) in the outcomes of the visual comparison of both sides of the face from the 5 blinded reviewers then the assessment will not contribute to the analysis.||participants|||Number
768888|NCT00708071|Secondary|Visual Comparison of Ecchymosis at Day 5|Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs.|Through Postoperative Day 5|Per Protocol. If there is no majority (i.e., 3 or more in agreement) in the outcomes of the visual comparison of both sides of the face from the 5 blinded reviewers then the assessment will not contribute to the analysis.||participants|||Number
768889|NCT00708071|Secondary|Visual Comparison of Ecchymosis at Day 1|Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs.|Through Postoperative Day 1|Per Protocol. If there is no majority (i.e., 3 or more in agreement) in the outcomes of the visual comparison of both sides of the face from the 5 blinded reviewers then the assessment will not contribute to the analysis.||participants|||Number
768890|NCT00708071|Primary|Visual Comparison of Ecchymosis at Postoperative Day 3|Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs.|Through Postoperative Day 3|Per Protocol. If there is no majority (i.e., 3 or more in agreement) in the outcomes of the visual comparison of both sides of the face from the 5 blinded reviewers then the assessment will not contribute to the analysis.||participants|||Number
768896|NCT00708110|Secondary|Number of Participants With the Emergence of Drug Resistance Mutations|The number of participants with the emergence (from Baseline) of drug resistance mutations at Day 11 was measured.|Baseline and Day 11|ITT(E) Population||participants|||Number
768897|NCT00708110|Secondary|Median Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Count at Day 11|Median change from Baseline in CD4+ cell count was calculated as the Day 11 value minus the Baseline value.|Baseline and Day 11|Per-Protocol Population: all participants included in the ITT(E) Population, excluding those who had at least one major protocol deviation||Cells per cubic millimeter (cells/mm^3)||Full Range|Median
768900|NCT00708110|Primary|Number of Participants With the Indicated Grade 3 and Grade 4 Laboratory Abnormalities|Clinical laboratory toxicities were graded according to the National Institutes of Allergy and Infectious Diseases (NIAID), Division of Acquired Immunodeficiency Syndrome (DAIDS). Grade 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented only for Grade 3 and Grade 4 laboratory abnormalities. Clinical laboratory abnormalities included: increased glucose, lipase, decreased platelets, and triglycerides.|Screening; Days 1, 3, 7, and 10; and Follow-up (up to Study Day 21)|Safety Population||participants|||Number
768901|NCT00708110|Primary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings|A 12-lead electrocardiogram (ECG) was performed by qualified personnel at the site after the participant had rested for at least 5 minutes in a semi-recumbent or supine position. If a QTc measurement of >=500 milliseconds (msec) was noted on a scheduled or unscheduled ECG, two additional ECGs were to be obtained within 5 minutes to confirm the abnormality. The number of participants with abnormal clinically significant (CS) and not clinically significant (NCS) ECG findings are presented here. The site determined if an ECG finding is significant or not. ECGs were obtained at Screening, Day 1 (pre-dose [twice] and then 1.0, 1.5, and 2.0 hours [hrs] post dose), Day 4 (pre-dose), Day 7 (pre-dose), Day 10 (pre-dose and then 1.0, 1.5, and 2.0 hrs post dose), Day 11 (prior to the 24 hr PK sample [pre lab]), and Follow-up.|Screening; Days 1, 7, 10, 11; and Follow-up (up to Study Day 21)|Safety Population. Only those participants who were available at the indicated time points were analyzed.||participants|||Number
768902|NCT00708110|Primary|Change From Baseline in Mean Heart Rate at Days 1, 4, 7, and 10|Heart rate is the measure of heart beats per minute (bpm). Change in the mean heart rate from Baseline was calculated as the post-Baseline value minus the Baseline value. Data are presented for change from Baseline at Day 1 (2 hours post dose [hrs]), Day 4 (1 hr pre-dose), Day 7 (1 hr pre-dose), and Day 10 (1 hr pre-dose and 2 hrs post dose).|Baseline and Days 1, 4, 7, and 10|Safety Population||beats per minute||Standard Deviation|Mean
768903|NCT00708110|Primary|Change From Baseline in Mean Blood Pressure at Days 1, 4, 7, and 10|Blood pressure measurement included systolic blood pressure (SBP) and diastolic BP (DBP). Change in the mean blood pressure from Baseline was calculated as the post-Baseline value minus the Baseline value. Data are presented for change from Baseline at Day 1 (2 hours post dose [hrs]), Day 4 (1 hr pre-dose), Day 7 (1 hr pre-dose), and Day 10 (1 hr pre-dose and 2 hrs post dose).|Baseline and Days 1, 4, 7, and 10|Safety Population||millimeters of mercury (mmHg)||Standard Deviation|Mean
768904|NCT00708110|Primary|Number of Participants Who Received the Indicated Concomitant Medications During the Study Period|Concomitant medications received during the study period are presented by generic term. Only those concomitant medications that were received by at least two participants are presented. “Multiple ingredient” is the term used in the statistical package for items that contain more than one active ingredient.|From Baseline (Day 1) until Follow-up (average of 3 study weeks)|Safety Population. Only those participants who received a concomitant medication were analyzed.||participants|||Number
768905|NCT00708110|Primary|Number of Participants With Any Non-serious Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.|From Baseline (Day 1) until Follow-up (average of 3 study weeks)|Safety Population: all participants who were randomized into the study with documented evidence of having received at least one dose of randomized treatment||participants|||Number
768906|NCT00708110|Primary|Apparent Clearance (CL/F) of GSK1349572 Following Dose Administration on Day 10|The CL/F is defined as the apparent total clearance of the drug from plasma after oral administration. Blood samples for PK analysis of GSK1349572 were obtained on Day 10 at pre-dose (within 15 minutes prior to dose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post GSK1349572 dose administration.|Day 10|PKS Population. No participants were analyzed for the placebo group.||L/hr||Geometric Coefficient of Variation|Geometric Mean
768907|NCT00708110|Primary|Terminal Half-life (t1/2) of GSK1349572 Following the Last Repeat Administration on Day 10|The terminal half-life (t1/2) of GSK1349572 is defined as the time required for the plasma concentration of GSK1349572 to reach half of its original concentration. Blood samples for PK analysis of GSK1349572 were obtained on Day 10 at pre-dose (within 15 minutes prior to dose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post GSK1349572 dose administration.|Day 10|PKS Population. No participants were analysed for the placebo group.||Hours||Geometric Coefficient of Variation|Geometric Mean
768908|NCT00708110|Primary|Time to the Maximum Observed Concentration (Tmax) of GSK1349572 Following the Last Repeat Administration on Day 10|tmax is defined as the time to the maximum obsevered plasma concentration. Blood samples for PK analysis of GSK1349572 were obtained on Day 10 at pre-dose (within 15 minutes prior to dose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post GSK1349572 dose administration. From the plasma concentration-time curve, tmax was determined by standard non-compartmental analysis using WinNonlin Pro 4.1 or higher.|Day 10|PKS Population. No participants were analyzed for the placebo group.||Hours||Full Range|Median
768909|NCT00708110|Primary|Pre-dose Concentration (C0), Concentration at the End of the Dosing Interval (Ctau), Minimum Observed Concentration During One Dosing Interval (Cmin), and Maximum Obsevered Plasma Concentration (Cmax) of GSK1349572 Following the Last Repeat Administration|C0 is defined as the pre-dose concentration. Ctau is defined as the concentration at the end of the dosing interval. Cmin is defined as the minimum observed concentration during one dosing interval. Cmax is defined as the maximum obsevered plasma concentration. Blood samples for PK analysis of GSK1349572 were obtained on Day 10 at pre-dose (within 15 minutes prior to dose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post GSK1349572 dose administration.|Day 10|PKS Population. No participants were analyzed for the placebo group.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
768940|NCT00708162|Secondary|Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 50 Copies/mL at Week 96|The percentage of participants achieving and maintaining confirmed HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the FDA-defined TLOVR algorithm, which takes into account a patient's longitudinal viral load up to the predefined time point by considering patterns of suppression and rebounding.|Week 96|ITT Analysis Set||percentage of participants|||Number
768910|NCT00708110|Primary|Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) of GSK1349572 Following the Last Repeat Administration on Day 10|AUC is defined as the area under the GSK1349572 concentration-time curve as a measure of drug exposure. AUC(0-tau) is defined as the area under the concentration-time curve over the dosing interval. Blood samples for PK analysis of GSK1349572 were obtained on Day 10at pre-dose (within 15 minutes prior to dose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post GSK1349572 dose administration.|Day 10|PKS Population. No participants were analyzed for the placebo group.||µg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
768911|NCT00708110|Primary|Apparent Clearance (CL/F) of GSK1349572 Following Dose Administration on Day 1|The CL/F is defined as the apparent total clearance of the drug from plasma after oral administration. Blood samples for PK analysis of GSK1349572 were obtained on Day 1at pre-dose (within 15 minutes prior to dose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post GSK1349572 dose administration.|Day 1|PKS Population. No participants were analyzed for the placebo group.||Liters per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
768912|NCT00708110|Primary|Terminal Half-life (t1/2) of GSK1349572 Following Dose Administration on Day 1|The terminal half-life (t1/2) of GSK1349572 is defined as the time required for the plasma concentration of GSK1349572 to reach half of its original concentration. Blood samples for PK analysis of GSK1349572 were obtained on Day 1at pre-dose (within 15 minutes prior to dose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post GSK1349572 dose administration.|Day 1|PKS Population. No participants were analyzed for the placebo group.||Hours||Geometric Coefficient of Variation|Geometric Mean
768913|NCT00708110|Primary|Time to Maximum Observed Concentration (Tmax) and Absorption Lag Time (Tlag) of GSK1349572 Following Dose Administration on Day 1|tmax is defined as the time to the maximum obsevered plasma concentration. Absorption lag time is defined as the time taken for a drug to appear in the systemic circulation following administration. tlag was estimated based on PK sampling times of 0 (pre-dose), 0.5, 1, 1.5, 2 3, 4, 6, 8, 12, and 24 hours post-dose. Blood samples for PK analysis of GSK1349572 were obtained on Day 1at pre-dose (within 15 minutes prior to dose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post GSK1349572 dose administration. From the plasma concentration-time curve, tmax was determined by standard non-compartmental analysis using WinNonlin Pro 4.1 or higher.|Day 1|PKS Population. No participants were analyzed for the placebo group.||Hours||Full Range|Median
768914|NCT00708110|Primary|Maximum Observed Plasma Concentration (Cmax) and Concentration at 24 Hours Post Dose (C24) of GSK1349572 Following Dose Administration on Day 1|Cmax is defined as the maximum observed plasma concentration, and C24 is defined as the concentration at 24 hours post dose. Blood samples for PK analysis of GSK1349572 were obtained on Day 1at pre-dose (within 15 minutes prior to dose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post GSK1349572 dose administration. From the plasma concentration-time curve, Cmax was determined by standard non-compartmental analysis using WinNonlin Pro 4.1 or higher.|Day 1|PKS Population. No participants were analyzed in the placebo group.||Micrograms per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
768915|NCT00708110|Primary|Area Under the Plasma Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-inf]) and Over 24 Hours (AUC[0-24]) of GSK1349572 Following Dose Administration on Day 1|AUC is defined as the area under the GSK1349572 concentration-time curve as a measure of drug exposure. AUC(0-inf) is defined as the area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time. AUC(0-24) is defined as the area under the concentration-time curve from time zero (pre-dose) to24 hours. Blood samples for pharmacokinetic (PK) analysis of GSK1349572 were obtained on Day 1at pre-dose (within 15 minutes prior to dose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post GSK1349572 dose administration.|Day 1|Pharmacokinetic Summary (PKS) Population: participants (par.) with an evaluable profile of GSK1349572 on Day 10. Par. were excluded if they vomited within 2 hours of dosing on Day 10, missed more than one dose 2 days prior to Day 10, and took prohibited concomitant medication during the treatment period. No par. were analyzed in the placebo group.||Micrograms*hour per milliliter (µg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
768916|NCT00708110|Secondary|Number of Participants With HIV-1 RNA <400 Copies/mL and <50 Copies/mL|The number of participants who achieved plasma HIV-1 RNA levels <400 copies/mL and <50 copies/mL through Day 11 was measured.|Day 11|ITT(E) Population||participants|||Number
768917|NCT00708110|Secondary|Plasma HIV-1 RNA Rate of Decline Over 10 Days|The rate of decline of plasma HIV-1 RNA levels from Day 1 to Day 11 was measured.|Day 1 to Day 11|ITT(E) Population||Log10 copies/mL/day||90% Confidence Interval|Mean
768918|NCT00708110|Secondary|Median Change From Baseline in Plasma HIV-1 RNA to Nadir (Maximum Change) at Day 11|Plasma HIV-1 RNA change from Baseline to the on-treatment nadir (maximum change) was calculated as the post-Baseline value minus the Baseline value.|Baseline and Day 11|ITT(E) Population||Log10 copies/mL||Full Range|Median
768919|NCT00708110|Secondary|Mean Change From Baseline in Plasma HIV-1 RNA to Nadir (Maximum Change) at Day 11|Plasma HIV-1 RNA change from Baseline to the on-treatment nadir (maximum change) was calculated as the post-Baseline value minus the Baseline value.|Baseline and Day 11|ITT(E) Population||Log10 copies/mL||Standard Deviation|Mean
768920|NCT00708110|Primary|Change From Baseline in Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) at Day 11|Change from Baseline in Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) was calculated as the Day 11 value minus the Baseline value. Blood samples for the measurement of HIV-1 RNA levels were obtained throughout the treatment period (Day 1 to Day 11).|Baseline (Day 1) and Day 11|Intent to Treat Exposed (ITT[E]) Population: all participants who met study criteria and were randomized into the study with documented evidence of having received at least one dose of randomized treatment and at least one post-baseline HIV-1 RNA measurement||Log10 copies/milliliter (log10 copies/mL||Standard Deviation|Mean
769580|NCT00706004|Secondary|Serum Calcium||baseline and 4 weeks|Participants who completed the study||mg/dL||Standard Deviation|Mean
769581|NCT00706004|Secondary|ALT||baseline and 4 weeks|Participants who completed the study||U/L||Standard Deviation|Mean
768924|NCT00708162|Secondary|Change From Baseline in CD4 Cell Count at Week 96|The change from baseline in CD4 cell count (cells/mm^3) at Week 96 was analyzed.|Baseline to Week 96|Participants in the ITT Analysis Set with evaluable change data at Week 96 were analyzed.||cells/mm^3||Standard Deviation|Mean
768925|NCT00708162|Secondary|Change From Baseline in CD4 Cell Count at Week 48|The change from baseline in CD4 cell count (cells/mm^3) at Week 48 was analyzed.|Baseline to Week 48|Participants in the ITT Analysis Set with evaluable change data at Week 48 were analyzed.||cells/mm^3||Standard Deviation|Mean
768926|NCT00708162|Secondary|Change From Baseline in HIV-1 RNA at Week 96|The change from baseline in log10 HIV-1 RNA (copies/mL) at Week 96 was analyzed.|Baseline to Week 96|Participants in the ITT Analysis Set with evaluable change data at Week 96 were analyzed.||log10 copies/mL||Standard Deviation|Mean
768927|NCT00708162|Secondary|Change From Baseline in HIV-1 RNA at Week 48|The change from baseline in log10 HIV-1 RNA (copies/mL) at Week 48 was analyzed.|Baseline to Week 48|Participants in the ITT Analysis Set with evaluable change data at Week 48 were analyzed.||log10 copies/mL||Standard Deviation|Mean
768928|NCT00708162|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96|The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 96 was analyzed using the missing = failure method.|Week 96|ITT Analysis Set||percentage of participants|||Number
768929|NCT00708162|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48|The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 48 was analyzed using the missing = failure method.|Week 48|ITT Analysis Set||percentage of participants|||Number
768930|NCT00708162|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the missing = failure method.|Week 96|ITT Analysis Set||percentage of participants|||Number
768931|NCT00708162|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the missing = failure method, where participants with missing data were considered as having failed to meet the criteria for evaluation.|Week 48|ITT Analysis Set||percentage of participants|||Number
768932|NCT00708162|Secondary|Percentage of Participants With Pure Virologic Failure (HIV-1 RNA Cutoff at 400 Copies/mL) up to Week 96|The percentage of participants with pure virologic failure (HIV-1 RNA cutoff at 400 copies/mL) up to Week 96 was estimated using the Kaplan-Meier method in the time to event analysis.|Baseline to Week 96|ITT Analysis Set||percentage of participants||95% Confidence Interval|Number
768933|NCT00708162|Secondary|Percentage of Participants With Pure Virologic Failure (HIV-1 RNA Cutoff at 400 Copies/mL) up to Week 48|The percentage of participants with pure virologic failure (HIV-1 RNA cutoff at 400 copies/mL) up to Week 48 was estimated using the Kaplan-Meier method in the time to event analysis.|Baseline to Week 48|ITT Analysis Set||percentage of participants||95% Confidence Interval|Number
768934|NCT00708162|Secondary|Percentage of Participants With Pure Virologic Failure (HIV-1 RNA Cutoff at 50 Copies/mL) up to Week 96|The percentage of participants with pure virologic failure (HIV-1 RNA cutoff at 50 copies/mL) up to Week 96 was estimated using the Kaplan-Meier method in the time to event analysis.|Baseline to Week 96|ITT Analysis Set||percentage of participants||95% Confidence Interval|Number
768935|NCT00708162|Secondary|Percentage of Participants With Pure Virologic Failure (HIV-1 RNA Cutoff at 50 Copies/mL) up to Week 48|The percentage of participants with pure virologic failure (HIV-1 RNA cutoff at 50 copies/mL) up to Week 48 was estimated using the Kaplan-Meier method in the time to event analysis.|Baseline to Week 48|ITT Analysis Set||percentage of participants||95% Confidence Interval|Number
768936|NCT00708162|Secondary|Virologic Response at Week 96 (HIV-1 RNA < 50 Copies/mL)|Virologic response at Week 96 (percentage of participants with HIV-1 RNA < 50 copies/mL) was analyzed using the FDA-defined Snapshot algorithm, which defines a patient's virologic response status using the viral load along with study drug discontinuation status at the predefined time point within an allowed window of time.|Week 96|ITT Analysis Set||percentage of participants|||Number
768937|NCT00708162|Secondary|Virologic Response at Week 48 (HIV-1 RNA < 50 Copies/mL)|Virologic response at Week 48 (percentage of participants with HIV-1 RNA < 50 copies/mL) was analyzed using the FDA-defined Snapshot algorithm, which defines a patient's virologic response status using the viral load along with study drug discontinuation status at the predefined time point within an allowed window of time.|Week 48|ITT Analysis Set||percentage of participants|||Number
768938|NCT00708162|Secondary|Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 400 Copies/mL at Week 96|The percentage of participants achieving and maintaining confirmed HIV-1 RNA < 400 copies/mL at Week 96 was analyzed using the FDA-defined TLOVR algorithm, which takes into account a patient's longitudinal viral load up to the predefined time point by considering patterns of suppression and rebounding.|Week 96|ITT Analysis Set||percentage of participants|||Number
768941|NCT00708162|Primary|Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 50 Copies/mL at Week 48|The percentage of participants achieving and maintaining confirmed HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the FDA-defined Time to Loss of Virologic Response (TLOVR) algorithm, which takes into account a patient's longitudinal viral load up to the predefined time point by considering patterns of suppression and rebounding.|Week 48|ITT Analysis Set||percentage of participants|||Number
768942|NCT00708175|Other Pre-specified|Number of Participants With Fracture|Number of participants with confirmed (through an adjudication process) fractures during the study. Circumstances surrounding the fracture, available X-ray and other diagnostic results and healing status were collected for the adjudication process.|Up to 18 months.|All randomized participants who received at least 1 dose of study medication (Full Analysis Set).||participants|||Number
768943|NCT00708175|Other Pre-specified|Number of Participants Who Converted to Type 2 Diabetes Mellitus (T2DM)|Participants were considered to have converted to T2DM if there were ≥2 consecutive post-Baseline FPG measurements ≥126 mg/dL. Participants meeting criteria were tabulated and summarized by Study Period (Treatment and Follow-up). Conversion to T2DM during Treatment Period occurred if either both of the consecutive post-Baseline high FPG values, or the first of the 2 consecutive high values occurred on or before the first day off study drug. Conversion to T2DM occurred during the Follow-up Period if both consecutive high values occurred after at least 1 day after the Treatment Period.|Up to 18 months.|All randomized participants who received at least 1 dose of study medication (Full Analysis Set).||participants|||Number
768944|NCT00708175|Other Pre-specified|Change in Fasting Plasma Glucose (FPG)|The change between the fasting plasma glucose value collected at each time frame indicated.|Baseline and Month 12; Month 12 and Month 18.|All randomized participants who received at least 1 dose of study medication (Full Analysis Set).||mg/dL||Standard Error|Least Squares Mean
768945|NCT00708175|Secondary|Percent Change From Month 12 to Month 18 in Bone Mineral Density in the Total Proximal Femur by DXA|The change in bone mineral density in the total proximal femur at month 18 relative to month 12. DXA is a means of measuring BMD through x-ray.|Month 12 and Month 18.|All randomized participants who received at least 1 dose of study medication (Full Analysis Set). This was an observed case analysis with no imputation for missing data.||percent||Standard Error|Least Squares Mean
768946|NCT00708175|Primary|Percent Change From Baseline to Month 12 in Bone Mineral Density in the Total Proximal Femur by Dual-Energy-Ray Absorptiometry (DXA)|The change in bone mineral density in the total proximal femur at month 12 relative to baseline. DXA is a means of measuring BMD through x-ray.|Baseline and Month 12.|All randomized participants who received at least 1 dose of study medication (Full Analysis Set). This was an observed case analysis with no imputation for missing data. If a valid pre-treatment scan was not available, the earliest (within 30 days) post-dosing scan was used as Baseline. There was one such participant for this endpoint.||percent||Standard Error|Least Squares Mean
768947|NCT00708201|Secondary|Percentage of Participants With Blinded Adjudicated Cardiovascular (CV) Events|CV events of interest included congestive heart failure, CV death, cerebrovascular accident, myocardial infarction, serious arrhythmia, and unstable angina. CV events were adjudicated by a blinded external committee.|Baseline to 30 days post discharge|All participants who received at least 1 dose of study medication.||percentage of participants|||Number
768948|NCT00708201|Secondary|Percentage of Participants Considered DOW Responders at 5 Cutoff Time Points|DOW responders were defined as those participants who met all the following criteria: achieved DOW by the cutoff point, did not have hospital stay prolonged because of POI, and did not have readmission for POI within 7 days of actual hospital discharge. PSD were measured in 24 hour increments after surgery.|Day of surgery (Day 0) through PSD 3, PSD 4, PSD 5, PSD 6, and PSD 7|All participants who received at least 1 dose of study medication, who had at least 1 postdose GI assessment, who had the protocol-specified surgery, and had evaluable time to achieve G12 data.||percentage of participants|||Number
768949|NCT00708201|Secondary|Percentage of Participants Considered G12 Responders at 5 Cutoff Time Points|Time to achieve recovery of GI function was measured by a composite endpoint of time to first BM and time to tolerate first solid food (solids). This endpoint was referred to as GI2, and GI2 was calculated as follows: GI2 = max (solids, BM). GI2 responders were defined as those participants who met all the following criteria: achieved GI2 by the cutoff point, did not have hospital stay prolonged because of POI, and did not have readmission for POI within 7 days of actual hospital discharge. Postsurgery Days (PSD) were measured in 24 hour increments after surgery.|Day of surgery (Day 0) through PSD 3, PSD 4, PSD 5, PSD 6, and PSD 7|All participants who received at least 1 dose of study medication, who had at least 1 postdose GI assessment, who had the protocol-specified surgery, and had evaluable time to achieve G12 data.||percentage of participants|||Number
768950|NCT00708201|Secondary|Percentage of Participants With Postoperative Morbidity (POM)|POM was defined as the need for postoperative nasogastric (NG) tube insertion, hospital stay prolonged because of postoperative ileus (POI) (as determined by the investigator), or readmission (readmiss) to the hospital (hosp) for POI within 7 days (d) after discharge.|During hospitalization or within 7 days after discharge|All participants who received at least 1 dose of study medication, who had at least 1 postdose GI assessment, who had the protocol-specified surgery, and had evaluable POM data.||percentage of participants|||Number
768951|NCT00708201|Secondary|Percentage of Participants Considered Postoperative LOS Responders|A participant was considered a postoperative LOS responder if the postoperative LOS was less than or equal to 7 days. The postoperative LOS for a participant was calculated as follows: (date of DOW) - (date of surgery). Participants with missing data were considered nonresponders.|Day of surgery (Day 0) up to 7 days after surgery|All participants who received at least 1 dose of study medication, who had at least 1 postdose GI assessment, who had the protocol-specified surgery, and had evaluable postoperative LOS data.||percentage of participants|||Number
768952|NCT00708201|Secondary|Postoperative Length of Stay (LOS)|The postoperative LOS was determined by the difference between the date of hospital DOW and the date of surgery; that is, the postoperative LOS for a participant was calculated as follows: (date of DOW) - (date of surgery).|Day of surgery (Day 0) to the day of hospital DOW|All participants who received at least 1 dose of study medication, who had at least 1 postdose GI assessment, who had the protocol-specified surgery, and had evaluable postoperative LOS data.||Days||Standard Deviation|Mean
769582|NCT00706004|Secondary|AST||baseline and 4 weeks|Participants who completed the study||U/L||Standard Deviation|Mean
769583|NCT00706004|Secondary|Serum Creatinine||baseline and 4 weeks|Participants who completed the study||mg/dL||Standard Deviation|Mean
768953|NCT00708201|Secondary|Mean Time to Discharge Order Written (DOW) Using KM Estimates|"The KM estimate reported below is biased because of the censoring of the last observation.
Censoring Rules for Study Participants who:
Completed: the censored time for the event was determined as: censored time = minimum [maximum (time of/to last GI assessment, time of/to hospital discharge order written), study duration].
Discontinued: censored time = maximum (time of/to last GI assessment, time of/to discontinuation)"|Day of surgery (Day 0) up to 10 days in hospital|All participants who received at least 1 dose of study medication, who had at least 1 postdose GI assessment, who had the protocol-specified surgery, and had evaluable time to DOW data. 36 participants in the Placebo group and 15 participants in the Alvimopan group were censored.||Hours||Standard Error|Mean
768954|NCT00708201|Secondary|Mean Time to Ready for Discharge From Hospital Analyzed by KM Estimates and Cox PH Model|"The endpoint of “time to ready for discharge” was based solely on the recovery of GI function as determined by the surgeon. The KM estimate reported below is biased because of the censoring of the last observation.
Censoring Rules for Study Participants who:
Completed: the censored time for the event was determined as: censored time = minimum [maximum (time of/to last GI assessment, time of/to hospital discharge order written), study duration].
Discontinued: censored time = maximum (time of/to last GI assessment, time of/to discontinuation)"|Day of surgery (Day 0) up to 10 days in hospital|All participants who received at least 1 dose of study medication, who had at least 1 postdose GI assessment, who had the protocol-specified surgery, and had evaluable ready to discharge data. 21 participants in the Placebo group and 12 participants in the Alvimopan group were censored.||Hours||Standard Error|Mean
768955|NCT00708201|Primary|Mean Time to Achieve GI2 Analyzed by Kaplan-Meier (KM) Estimates and Cox Proportional Hazards (PH) Model|"Time to achieve recovery of gastrointestinal (GI) function as measured by a composite endpoint of both upper GI recovery (toleration of solid food) and lower GI recovery (first bowel movement [BM]) using KM Estimates and Cox PH Model. This endpoint was referred to as GI2. GI2 was calculated as GI2 = maximum (max) (solids, BM). The KM estimate reported below is biased because of the censoring of the last observation.
Censoring Rules for Study Participants who:
Completed: the censored time for the event was determined as: censored time = minimum [maximum (time of/to last GI assessment, time of/to hospital discharge order written), study duration].
Discontinued: censored time = maximum (time of/to last GI assessment, time of/to discontinuation)"|From day of surgery (Day 0) up to 10 days in hospital|All participants who received at least 1 dose of study medication, who had at least 1 postdose GI assessment, who had the protocol-specified surgery, and had evaluable time to achieve G12 data. 39 participants in the Placebo group and 17 participants in the Alvimopan group were censored.||Hours||Standard Error|Mean
768956|NCT00708214|Secondary|Best Change From Baseline in ECOG Performance Status|Best change from baseline in ECOG (Eastern Cooperative Oncology Group) performance status. ECOG is measured as score between 0 (fully active) and 5 (dead). Improvement is a decrease in ECOG score from baseline of at least 1. Deterioration is an increase in ECOG score from baseline of at least 1|baseline till end of treatment|||participants|||Number
768957|NCT00708214|Secondary|Change From Baseline in Ca15.3|Change from baseline in Ca15.3 tumor marker levels|baseline and day 29|Analysis of all treatment arms combined for tumor marker analysis.||percentage of baseline level||Full Range|Median
768958|NCT00708214|Secondary|Time From Dosing to the Maximum Concentration of Letrozole in Plasma at Steady State (Tmax,ss)|tmax,ss represents the time from dosing to the maximum concentration of letrozole in plasma at steady state.|0.05 hours (h) before dosing and 2h, 4h, 6h, 8h and 24h after dosing|Analysis of all treatment arms combined, as Letrozole dose was the same in all arms.||hours||Full Range|Median
768959|NCT00708214|Secondary|Maximum Concentration of Letrozole in Plasma at Steady State (Cmax,ss)|Cmax,ss represents the maximum measured concentration of letrozole in plasma at steady state.|0.05 hours (h) before dosing and 2h, 4h, 6h, 8h and 24h after dosing|Analysis of all treatment arms combined, as Letrozole dose was the same in all arms.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
768960|NCT00708214|Secondary|Area Under Curve of Letrozole Over a Uniform Dosing Interval Tau at Steady State (AUCtau,ss)|AUC0-tau,ss represents the area under the concentration curve of letrozole in plasma over a uniform dosing interval tau at steady state.|0.05 hours (h) before dosing and 2h, 4h, 6h, 8h and 24h after dosing|Analysis of all treatment arms combined, as Letrozole dose was the same in all arms.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
768961|NCT00708214|Secondary|Time From Dosing to the Maximum Concentration of Afatinib in Plasma at Steady State (Tmax,ss)|tmax,ss represents the time from dosing to the maximum concentration of afatinib in plasma at steady state|0.05 hours (h) before dosing and 2h, 4h, 6h, 8h and 24h after dosing|Data were particularly sparse for the 50 mg starting dose group and were not summarised.||hours||Full Range|Median
768962|NCT00708214|Secondary|Pre-dose Concentration of Afatinib in Plasma at Steady Stateon Day 85 (Cpre,ss,85)|Cpre,ss,85 represents the pre-dose concentration of afatinib in plasma at steady state on day 85.|Day 85|Data were particularly sparse for the 50 mg starting dose group and were not summarised.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
768963|NCT00708214|Secondary|Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 57 (Cpre,ss,57)|Cpre,ss,57 represents the pre-dose concentration of afatinib in plasma at steady state on day 57.|Day 57|Data were particularly sparse for the 50 mg starting dose group and were not summarised.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
768964|NCT00708214|Secondary|Maximum Concentration of Afatinib in Plasma at Steady State (Cmax,ss)|Cmax,ss represents the maximum measured concentration of afatinib in plasma at steady state.|0.05 hours (h) before dosing and 2h, 4h, 6h, 8h and 24h after dosing|Data were particularly sparse for the 50 mg starting dose group and were not summarised.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
768965|NCT00708214|Secondary|Area Under Curve of Afatinib Over a Uniform Dosing Interval Tau at Steady State (AUCtau,ss)|AUCtau,ss represents the area under the concentration curve of afatinib in plasma over a uniform dosing interval tau at steady state.|0.05 hours (h) before dosing and 2h, 4h, 6h, 8h and 24h after dosing|Data were particularly sparse for the 50 mg starting dose group and were not summarised.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
768966|NCT00708214|Secondary|Overall Survival (OS)|OS was defined as the time from first treatment to death.|Baseline till progression, death or data cut-off|TS. Estimation of median time to death was not feasible, due to the small number of patients who died during the trial.||days||95% Confidence Interval|Median
769584|NCT00706004|Secondary|Serum BUN||baseline and 4 weeks|Participants who completed the study||mg/dL||Standard Deviation|Mean
768969|NCT00708214|Secondary|Time to RECIST Tumour Reponse|The time to OR was the duration from the first treatment to the time when the measurement criteria for CR and/or PR were met according to RECIST criteria.|Baseline till progression|TS. Median time to RECIST tumour response was not calculable as there was no OR observed.||days||95% Confidence Interval|Median
768970|NCT00708214|Secondary|Number of Participants With Clinical Benefit (CB)|CB was defined as CR, PR or stable disease (SD) and was assessed according to RECIST criteria regardless of treatment status.|16 weeks and 24 weeks|TS||Participants|||Number
768971|NCT00708214|Secondary|Number of Participants With Confirmed Objective Response (OR)|OR was defined as complete response (CR) or partial response (PR) and was assessed according to RECIST criteria regardless of treatment status.|Baseline till progression|TS||Participants|||Number
768972|NCT00708214|Primary|Percentage of Progression Free Participants After 16 Weeks of Treatment|Progression was defined according to 1 of the following criteria: New bone lesion(s) on bone scan or on magnetic resonance imaging; Progression or occurrence of new lesion(s) according to the Response Evaluation Criteria In Solid Tumours version 1.0 (RECIST); an increase in tumour marker CA 15.3 of more than 20 percent,compared with baseline, at 2 consecutive examinations; occurrence of disease-related skeletal events. If a patient did not fulfil any criteria and was withdrawn because of clinical deterioration amounting to PD according to the Investigator, they were considered as having PD.|16 weeks|Treated set (TS). TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.||Percentage of participants||95% Confidence Interval|Number
769438|NCT00713479|Primary|Diastolic Blood Pressure|Diastolic blood pressure is evaluated at 15 min intervals under placebo or varenicline in the presence of methamphetamine over 140 minutes post infusion. Data is pooled and the mean and standard deviation are presented.|15 minute intervals|||mm Hg|Participants|Standard Deviation|Mean
768980|NCT00708422|Secondary|Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Ocular Surface Disease Index (OSDI) Score|The OSDI is a 12-question validated questionnaire (resultant overall 0-100 score) used to measure ocular symptoms, visual function, and environmental factors that may affect a patient's vision, where 0 = normal and 100 = severe. The OSDI questionnaire was administered at both visits and completed by the patient with no assistance from the office staff, physician, or anyone else. The baseline OSDI score was subtracted from the 12-week OSDI score and reported as change. A negative number represents a perceived improvement in ocular health.|12 weeks (Day 84)|Intent-to-treat: All patients who received test article and completed the trial.||Units on a scale||Standard Deviation|Mean
768981|NCT00708422|Primary|Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Tear Film Break Up Time (TBUT)|Tear film break-up time was assessed by the same examiner both visits using the same slitlamp/settings. Examiner instilled fluorescein onto the patient's eye, after which the patient blinked several times, then kept the eye open. Immediately thereafter, the examiner used a stopwatch to time the occurrence of the first break in the fluorescein film. Three consecutive measurements were taken and averaged for actual TBUT. TBUT at Baseline (Day 0) was subtracted from TBUT at 12 weeks (Day 84) and reported as change. A higher number represents a lengthening in the tear film break up time.|12 weeks (Day 84)|Intent-to-treat: All patients who received test article and completed the trial.||seconds||Standard Deviation|Mean
768982|NCT00708435|Secondary|Overall Treatment-emergent Adverse Events (TEAEs)|Number of participants with TEAEs. Treatment-related AEs were defined as events whose relationship to study treatment was definitely related, probably related, or possibly related in the opinion of the investigator. AEs with missing relationship were considered related to treatment. Serious TEAEs were treatment-emergent SAEs. Deaths reported up to and including Day 45; one additional Beriplex death occurred after Day 45.|From the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs and from the start of infusion up to the allowed time window of the Day 45 visit for SAEs.|The ITT-S population included all participants who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'.||participants|||Number
768983|NCT00708435|Secondary|45-Day All-cause Mortality||Until Day 45|The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.||participants|||Number
768984|NCT00708435|Secondary|Use of Other Blood Products and Hemostatic Agents|Other blood products and hemostatic agents containing coagulation factors (such as whole blood, plasma, albumin, platelets) not including PRBCs.|From the start of infusion until 24 h after the start of infusion|The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.||Units of blood products||Standard Deviation|Mean
768985|NCT00708435|Secondary|Transfusion of Red Blood Cells|Red blood cells were packed red blood cells (PRBCs).|From the start of infusion until 24 h after the start of infusion|The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.||Units of PRBCs||Standard Deviation|Mean
768986|NCT00708435|Secondary|Percentage of Participants With INR Correction at Various Times After Randomization|The time taken from randomization to INR correction (defined as an INR ≤ 1.3) was recorded. The percentage of participants with INR correction was calculated at 2.5, 3, 5, 8, 14, and 26 h after randomization.|From randomization until INR correction; calculated at 2.5, 3, 5, 8, 14, and 26 h after randomization.|The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.||percentage of participants|||Number
768987|NCT00708435|Secondary|Percentage of Participants With INR Correction at Various Times After the Start of Infusion|The time taken from the start of infusion to INR correction (defined as an INR ≤ 1.3) was recorded. The percentage of participants with INR correction was calculated at 0.5, 1, 3, 6, 12, and 24 h after the start of infusion.|From the start of infusion until INR correction; calculated at 0.5, 1, 3, 6, 12, and 24 h after the start of infusion.|The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.||percentage of participants|||Number
768988|NCT00708435|Secondary|Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein S|Plasma levels are presented as the percentage of normal at pre-infusion and 30 min and 24 h after the start of infusion. The plasma level assay results are reported as a potency relative to a standard, where 100% is considered to be normal.|From preinfusion until 24 h after the start of infusion|The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.||percentage of normal||Standard Deviation|Mean
768989|NCT00708435|Secondary|Incremental in Vivo Recovery (IVR) (Response) of Factors II, VII, IX, and X, Protein C, and Protein S for Beriplex|The incremental IVR [(IU/dL)/(IU/kg)] was calculated as follows: (IU/dL activity rise in plasma)/(IU/kg body weight infused) = [maximum increase in component plasma level within 3 hours compared to pre-infusion (IU/dL)]/{[exact dose of component in drug administered (IU)]/[body weight (kg)]}.|Before infusion and up to 3 h after the start of infusion|The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.||(IU/dL)/(IU/kg body weight)||Standard Deviation|Mean
769004|NCT00708643|Primary|Lens Comfort|"Rating of lens comfort by rating agreement to the following statement:
The lenses I am wearing are comfortable.
Rating using the following scale:
1=strongly agree, 2=agree, 3=neutral, 4=disagree, 5=strongly disagree. The rating is averaged over all time frames."|At 3,7,10,13,17,21,24, and 27 days|The analysis includes all subjects that completed the study.||units on a scale||Standard Error|Least Squares Mean
769005|NCT00708643|Primary|Limbal Hyperemia|Measures the redness of the limbal region of the eye on a scale of 0 to 100 grade with 0=none and 100=severe. The analysis is the average grade over all time frames.|At 2 weeks and 4 weeks|The analysis includes all subjects that completed the study.||units on a scale||Standard Error|Least Squares Mean
768990|NCT00708435|Secondary|Percentage of Participants Who Had Hemostatic Efficacy for Visible or Non-visible Musculoskeletal Bleeding|Hemostatic efficacy was determined by a blinded independent board as excellent, good, or poor/none, based on prespecified definitions. Assessments of visible or non-visible musculoskeletal bleeding were made at 3 and 6 hours after the start of infusion. Hemostatic efficacy was the binary endpoint of effective or non-effective hemostasis, where ‘effective’ was a hemostatic efficacy rating of “excellent” or “good,” and ‘non-effective’ was a hemostatic efficacy rating of “poor/none”.|At 3 and 6 hours after the start of infusion|The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.||percentage of participants||95% Confidence Interval|Number
768991|NCT00708435|Primary|Percentage of Participants Who Had a Rapid Decrease of the International Normalized Ratio (INR)|A rapid decrease of the international normalized ratio (INR) was defined as an INR ≤ 1.3 at 30 minutes after the end of the infusion. The INR is a standard way to describe the time it takes for blood to clot; an INR range of 0.8 to 1.2 is considered normal for a healthy person who is not using oral anticoagulant therapy.|30 minutes after end of infusion|The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.||percentage of participants||95% Confidence Interval|Number
768992|NCT00708435|Primary|Percentage of Participants Achieving Hemostatic Efficacy of Stopping an Ongoing Major Bleed|Hemostatic efficacy was determined by a blinded independent board as excellent, good, or poor/none, based on prespecified definitions. Assessments of visible or non-visible musculoskeletal bleeding were made at 1 and 4 hours after the end of infusion. Hemostatic efficacy was the binary endpoint of effective or non-effective hemostasis, where ‘effective’ was a hemostatic efficacy rating of “excellent” or “good,” and ‘non-effective’ was a hemostatic efficacy rating of “poor/none”.|At 1 and 4 hours after the end of infusion|The Intention-to-Treat Efficacy (ITT-E) population included all randomized participants who had received any study product, presented with acute major bleeding, and had an international normalized ratio (INR) > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.||percentage of participants||95% Confidence Interval|Number
768993|NCT00708461|Primary|Change in Body Mass Index (BMI)|Assessed in kilograms per meter squared.|Baseline to 24 months|Participants with complete data at baseline and two years, and those who were not pregnant at either time, were retained for analysis.||kilograms per meter squared||Standard Error|Least Squares Mean
768994|NCT00708500|Secondary|Number of Participants With Undetectable HCV-RNA at Follow-up Week 12 and at 72 Weeks After Randomization.||At Follow-up Week 12 and at 72 weeks after randomization|FAS = all randomized subjects who received at least one dose of any study medication (Peg, RBV, or boceprevir/placebo).||participants|||Number
768995|NCT00708500|Secondary|Number of Participants With Early Virologic Response.|Having undetectable HCV-RNA at Week 2, 4, 8, or 12 was considered Early Virologic Response.|At Week 2, 4, 8, or 12|FAS = all randomized subjects who received at least one dose of any study medication (Peg, RBV, or boceprevir/placebo).||participants|||Number
768996|NCT00708500|Secondary|Sustained Virologic Response (SVR) Rate in the Modified Intent to Treat (mITT) Population.|"SVR is defined as undetectable plasma HCV-RNA at Follow-up Week 24. This outcome measure evaluates SVR after treatment with boceprevir and PEG2b plus RBV versus PEG2b plus RBV alone in participants with CHC genotype 1 who failed prior treatment.
This key secondary efficacy endpoint was added as per the second protocol amendment on 02 DEC 2009."|At Follow-up Week 24|mITT = all randomized subjects who received at least one dose of boceprevir (experimental arms) or boceprevir placebo (control arm).||Percentage of Participants|||Number
768997|NCT00708500|Primary|Sustained Virologic Response (SVR) Rate in the Full Analysis Set (FAS) Population.|SVR is defined as undetectable plasma hepatitis C virus RNA (HCV-RNA) at Follow-up Week 24. This outcome measure evaluates SVR after treatment with boceprevir and PEG2b plus RBV versus PEG2b plus RBV alone in participants with chronic hepatitis C (CHC) genotype 1 who failed prior treatment.|At Follow-up Week 24|FAS = all randomized subjects who received at least one dose of any study medication (Peg, RBV, or boceprevir/placebo).||Percentage of Participants|||Number
768998|NCT00708526|Secondary|Return of Cognitive Function|average time in minutes from the time the surgeon finished closing the surgical incision at the end of surgery until the patients could correctly state their full name, the current year and their day, month and year of birth|up to 30 minutes|number of participants determined by protocol||minutes||Standard Deviation|Mean
768999|NCT00708526|Primary|Recovery From Anesthesia|average time in minutes from the time the surgeon finished closing the surgical incision until the time the investigator in the postoperative care unit determined that the patients meet the discharge criteria from the postoperative anesthesia care unit (their vital signs had been stable for at least 30 min, their pain scores were less than the tolerable pain scores, they could sit up without dizziness or nausea, and their Aldrete score was ≥8).|up to 2 hours|||minutes||Standard Deviation|Mean
769000|NCT00708643|Secondary|Corneal Staining|A measure of corneal abrasion using a 0 to 100 scale with 0=none, 25=micropunctate, 50=macropunctate, 75=coalescence, 100=patch. The analysis is the average grade over all time frames.|At 2 weeks and 4 weeks.|||units on a scale||Standard Error|Least Squares Mean
769001|NCT00708643|Secondary|Tarsal Hyperemia|Measures the amount of redness to the tissue of the inside upper and lower eyelid using a 0 to 100 scale with 0=none and 100=severe.|At 2 weeks and 4 weeks.|The analysis includes all subjects that completed the study.||units on a scale||Standard Error|Least Squares Mean
769002|NCT00708643|Secondary|Tarsal Roughness|Measures the amount of roughness to the tissue of the inside upper and lower eyelid on a scale of 0 to 100 with 0=none and 100=severe. The analysis is the average grade over all time frames.|At 2 weeks and 4 weeks|The analysis includes all subjects that completed the study.||units on a scale||Standard Error|Least Squares Mean
769003|NCT00708643|Primary|Upper Lid Margin Staining|Measures the trauma to tissue that lines the margin of the inside of the upper eyelid on a 0 to 3 scale, with 0=none to 3=severe. The analysis is the average grade over all time frames.|At 2 weeks and 4 weeks.|The analysis includes all subjects that completed the study.||units on a scale.||Standard Error|Least Squares Mean
769585|NCT00706004|Secondary|Serum Bicarb||baseline and 4 weeks|Participants who completed the study||nmol/L||Standard Deviation|Mean
769586|NCT00706004|Secondary|Serum Potassium||baseline and 4 weeks|Participants who completed the study||nmol/L||Standard Deviation|Mean
769006|NCT00708682|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 Months of Age)|Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after toddler dose (12 months of age)|Safety population; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any systemic event.||Percentage of participants|||Number
769007|NCT00708682|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (6 Months of Age)|Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after dose 3 of Infant Series (6 months of age)|Safety population; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any systemic event.||Percentage of participants|||Number
769008|NCT00708682|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 Months of Age)|Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after dose 2 of Infant Series (4 months of age)|Safety population; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any systemic event.||Percentage of participants|||Number
769009|NCT00708682|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (2 Months of Age)|Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after dose 1 of Infant Series (2 months of age)|Safety population; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any systemic event.||Percentage of participants|||Number
769010|NCT00708682|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 to 2.0cm); Moderate (2.5 to 7.0cm); Severe (>7.0cm). Participants may be represented in more than 1 category.|Within 4 days after toddler dose (12 months of age)|Safety population; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any local reaction.||Percentage of participants|||Number
769011|NCT00708682|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 to 2.0cm); Moderate (2.5 to 7.0cm); Severe (>7.0cm). Participants may be represented in more than 1 category.|Within 4 days after dose 3 (6 months of age)|Safety population; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any local reaction.||Percentage of participants|||Number
769012|NCT00708682|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 to 2.0cm); Moderate (2.5 to 7.0cm); Severe (>7.0cm). Participants may be represented in more than 1 category.|Within 4 days after dose 2 of Infant Series (4 months of age)|Safety population; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any local reaction.||Percentage of participants|||Number
769013|NCT00708682|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0cm); Moderate (2.5 to 7.0cm); Severe (greater than [>] 7.0cm). Participants may be represented in more than 1 category.|Within 4 days after dose 1 of Infant Series (2 months of age)|Safety population: All participants who received at least 1 dose of the study vaccine; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any local reaction.||Percentage of participants|||Number
769014|NCT00708682|Other Pre-specified|GMC for Serotype-specific Pneumococcal IgG Antibody After the Toddler Dose|Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 7vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data after the toddler dose and after the third dose of the infant series.|Toddler Dose (12 months of age)|Evaluable Toddler Immunogenicity population subset where the number of participants analyzed (N) equals (=) those who had a valid and determinate assay result for antibody GMC at both the infant dose 3 and toddler dose.||mcg/mL||95% Confidence Interval|Geometric Mean
769015|NCT00708682|Other Pre-specified|GMC for Serotype-specific Pneumococcal IgG Antibody After Dose 3 of the Infant Series|Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 7vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data for the specified blood draw.|Dose 3 of infant series (6 months of age)|Evaluable 3-Dose Infant Immunogenicity population||mcg/mL||95% Confidence Interval|Geometric Mean
769016|NCT00708682|Other Pre-specified|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody After Dose 2 of the Infant Series|Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data for the specified blood draw.|Dose 2 of infant series (4 months of age)|Evaluable 2-Dose Infant Immunogenicity population||mcg/mL||95% Confidence Interval|Geometric Mean
769587|NCT00706004|Secondary|Serum Chloride||baseline and 4 weeks|Participants who completed the study||nmol/L||Standard Deviation|Mean
769017|NCT00708682|Secondary|Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Concentration ≥0.35mcg/mL, 1 Month After the Toddler Dose|Percentage of participants achieving predefined antibody threshold ≥0.35mcg/mL, along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.|1 month after the toddler dose (13 months of age)|Evaluable Toddler Immunogenicity population: eligible participants who received treatments as assigned at all 3 doses of the infant series and at the toddler dose, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations.||Percentage of participants||95% Confidence Interval|Number
769018|NCT00708682|Secondary|Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35mcg/mL, 1 Month After Dose 2 of the Infant Series|Percentage of participants achieving predefined antibody threshold ≥0.35mcg/mL, along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.|1 month after dose 2 of the infant series (5 months of age)|Evaluable 2-Dose Infant Immunogenicity population: eligible participants who received treatments as assigned at dose 1 and dose 2, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations.||Percentage of participants||95% Confidence Interval|Number
769019|NCT00708682|Primary|Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL), 1 Month After the Infant Series|Percentage of participants achieving predefined antibody threshold ≥0.35mcg/mL, along with the corresponding 95 percent confidence interval (95% CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.|1 month after the infant series (7 months of age)|Evaluable 3-Dose Infant Immunogenicity population: eligible participants who received treatments as assigned at all 3 doses, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations.||Percentage of participants||95% Confidence Interval|Number
769020|NCT00708708|Secondary|Number of Participants With Serious Adverse Events (SAEs) or Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants with AEs included participants affected with both SAEs and non-SAEs.|Cycle 1 Week 0 up to 30 days after end of study (where end of study was Cycle 6 Week 24)|Safety analysis set included all participants with available post-baseline safety data.||participants|||Number
769021|NCT00708708|Secondary|Criteria for Treatment Resumption|Criteria for resumption of therapy for another cycle by the physician were specified after the 5 drug-free intervals as 1) new disease activity (NDA), 2) prevention of deterioration (POD), 3) other reasons (included reasons like end of adverse event, frequent occurrence of adverse event or pre-specified therapy scheme), 4) new disease activity and prevention of deterioration, 5) new disease activity and other reason, 6) prevention of deterioration and other reason, and 7) new disease activity, prevention of deterioration, and other reasons.|Before Cycle 2, 3, 4, 5, 6|Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n’ signifies those participants who were evaluable for this measure at the specified time points.||participants|||Number
769022|NCT00708708|Secondary|Participant Perception of Drug-Free Interval: Recommendation of Therapy|A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before and after the drug-free interval participants were asked, “Would you recommend therapy with Enbrel to other patients with plaque-psoriasis?” Participants responded as yes or no to the question. Results are reported for participant’s likeliness to recommend therapy.|Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5|Efficacy analysis set. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n’ signifies those participants who were evaluable for this measure at the specified time points. Results are not reported for before Cycle 4, 5, 6, and after Cycle 5 as no participant was evaluable at these time points.||participants|||Number
769023|NCT00708708|Secondary|Participant Perception of Drug-Free Interval: Preference to Continuous Therapy|A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before and after the drug-free interval participants were asked, “If possible, would you prefer a continuous therapy without drug-free interval?” Participants responded as yes or no to the question. Results are reported for participant’s preference towards continuous therapy.|Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5|Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n’ signifies those participants who were evaluable for this measure at the specified time points.||participants|||Number
769024|NCT00708708|Secondary|Participant Perception of Drug-Free Interval: Comfort in Everyday Life|A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before and after the drug-free interval participants were asked to respond on a scale of 1 (no agreement) to 5 (complete agreement) to the statement, “A drug-free interval means more comfort in my everyday life.” Results are reported for participant’s perception of comfort of life during the drug-free interval.|Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5|Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n’ signifies those participants who were evaluable for this measure at the specified time points.||units on a scale||Standard Deviation|Mean
769588|NCT00706004|Secondary|Serum Sodium||baseline, 4 weeks|Participants who completed the study||nmol/L||Standard Deviation|Mean
769025|NCT00708708|Secondary|Participant Perception of Drug-Free Interval: Reminder of Disease|A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before and after the drug-free interval participants were asked to respond on a scale of 1 (no agreement) to 5 (complete agreement) to the statement, “During drug-free interval I will not be reminded permanently of my disease.” Results are reported for participant’s perception of reminder of disease during the drug-free interval.|Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5|Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n’ signifies those participants who were evaluable for this measure at the specified time points.||units on a scale||Standard Deviation|Mean
769026|NCT00708708|Secondary|Participant Perception of Drug-Free Interval: Risk for Adverse Drug Reactions|A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before and after the drug-free interval participants were asked to respond on a scale of 1 (no agreement) to 5 (complete agreement) to the statement, “A drug-free interval reduces the risk for adverse drug reactions.” Results are reported for participant’s perception of risk of adverse drug reactions.|Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5|Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n’ signifies those participants who were evaluable for this measure at the specified time points.||units on a scale||Standard Deviation|Mean
769027|NCT00708708|Secondary|Participant Perception of Drug-Free Interval: Satisfaction With Skin Condition|A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). After the drug-free interval participants were asked, “How much were you satisfied with the condition of your skin during the first half of the drug-free interval?” and “How much were you satisfied with the condition of your skin during the second half of the drug-free interval?” Participants responded on a scale of 1 (very dissatisfied) to 5 (very satisfied). Results are reported for participant’s satisfaction with their skin condition during the first half and second half of drug-free interval.|Before Cycle 2, 3, 4, 5, 6|Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n’ signifies those participants who were evaluable for this measure at the specified time points.||units on a scale||Standard Deviation|Mean
769028|NCT00708708|Secondary|Participant Perception of Drug-Free Interval: Disease Activity|A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). After the drug-free interval participants were asked, “How would you assess the activity of your disease during the first half of the drug-free interval?” and “How would you assess the activity of your disease during the second half of the drug-free interval?” Participants responded on a scale of 1 (no activity) to 5 (strongest possible activity). Results are reported for participant’s perception of disease activity during the first half and second half of drug-free interval.|Before Cycle 2, 3, 4, 5, 6|Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n’ signifies those participants who were evaluable for this measure at the specified time points.||units on a scale||Standard Deviation|Mean
769029|NCT00708708|Secondary|Participant Perception of Drug-Free Interval: Effective Therapy After Drug-Free Interval|A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before the drug-free interval participants were asked, “To what extend are you relieved by the fact that there is an effective therapy after the drug-free interval?” After the drug-free interval participants were asked, “To what extend were you relieved by the fact that there is an effective therapy after the drug-free interval?” Participants responded on a scale of 1 (not much relieved) to 5 (very much relieved). Results are reported for participant’s perception of effective therapy after drug-free interval.|Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5|Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n’ signifies those participants who were evaluable for this measure at the specified time points.||units on a scale||Standard Deviation|Mean
769030|NCT00708708|Secondary|Participant Perception of Drug-Free Interval: Relapse of Symptoms|A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before the drug-free interval participants were asked, “How much are you concerned about a relapse of symptoms?” After the drug-free interval participants were asked, “Were you concerned about a relapse of symptoms during the drug-free interval?” Participants responded on a scale of 1 (not concerned) to 5 (very much concerned). Results are reported for participant’s perception of relapse of symptoms.|Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5|Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n’ signifies those participants who were evaluable for this measure at the specified time points.||units on a scale||Standard Deviation|Mean
769031|NCT00708708|Secondary|Participant Perception of Drug-Free Interval: Duration|A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). After the drug-free interval participants were asked, “How would you assess the length of the current drug-free interval?” Participants responded on a scale of 1 (too long) to 5 (too short). Results are reported for participant’s perception of the duration of drug-free interval.|Before Cycle 2, 3, 4, 5, 6|Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n’ signifies those participants who were evaluable for this measure at the specified time points.||units on a scale||Standard Deviation|Mean
769115|NCT00709124|Secondary|Subgroup Analysis|For patients with >= 7 days of mechanical ventilation, we will compare the 2 groups for the following outcomes: Lower extremity muscle strength, mean change in MRC score from baseline to ICU discharge, mean change in MRC score from baseline to hospital discharge, and composite whole body MRC score at ICU dischare and at hospital discharge.|See description||||||
769032|NCT00708708|Secondary|Participant Perception of Drug-Free Interval: Liking of Drug-Free Interval|A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before the drug-free interval participants were asked, “Do you basically like the idea of a drug-free interval?” After the drug-free interval participants were asked, “How did you like the current drug-free interval?” Participants responded on a scale of 1 (not at all) to 5 (very good). Results are reported for participant’s liking of the drug-free interval.|Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5|Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n’ signifies those participants who were evaluable for this measure at the specified time points.||units on a scale||Standard Deviation|Mean
769033|NCT00708708|Secondary|Participant Perception of Drug-Free Interval: Reason for Returning to Practice|A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). After the drug-free interval participants were asked, “Why did you return to the practice today?” Responses included unscheduled visit due to new occurrence of disease, scheduled visit or other reasons (included reasons like treatment of adverse event, get a prescription or examination after external treatment). Results are reported for reasons for returning to the practice.|Before Cycle 2, 3, 4, 5, 6|Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n’ signifies those participants who were evaluable for this measure at the specified time points.||participants|||Number
769034|NCT00708708|Secondary|Participant Perception of Drug-Free Interval: Length of Drug-Free Interval|A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before the drug-free interval participants were asked, “How long do you expect the drug-free interval to last for?” After the drug-free interval participants were asked, “How long did the drug-free interval last?” Results are reported for participant’s perception of the length of drug-free interval.|Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5|Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n’ signifies those participants who were evaluable for this measure at the specified time points.||months||Standard Deviation|Mean
769035|NCT00708708|Secondary|Effect of Drug-Free Interval on Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade-Off (TTO)|"Effect of drug free interval on EQ-5D was determined by comparing the scores of the sub group Participants Without Drug-Free Interval to that of the sub group Participants With Drug-Free Interval. EQ-5D: participant rated questionnaire to assess health-related quality of life. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (extreme problems). Score of each domain is transformed into a single TTO value using formula developed by Greiner et al and results in a total score range -0.205 to 0.999; higher score indicates a better health state."|Week 0, 12, 24 of Cycle 1 to 6|Efficacy analysis set: all participants >= 18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here n’=number of participants evaluable at the specified time points for the given cycles.||units on a scale||Standard Deviation|Mean
769036|NCT00708708|Secondary|Effect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) Score|"Effect of drug free interval on DLQI was determined by comparing the scores of the sub group Participants Without Drug-Free Interval to that of the sub group Participants With Drug-Free Interval. DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst)."|Week 0, 12, 24 of Cycle 1 to 6|Efficacy analysis set: all participants >= 18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here ’n’=number of participants evaluable at the specified time points for the given cycles.||units on a scale||Standard Deviation|Mean
769037|NCT00708708|Secondary|Effect of Drug-Free Interval on Patient’s Global Assessment of Disease Activity (PatGA)|"Effect of drug-free interval on PatGA was determined by comparing the PatGA scores of the sub group Participants Without Drug-Free Interval to that of the sub group Participants With Drug-Free Interval. PatGA: participants were asked to rate the severity of their disease activity on a 6-point scale, where 0 = no activity and 5 = severe or maximum activity."|Week 0, 12, 24 of Cycle 1 to 6|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here, ’n’=number of participants evaluable for this measure at the specified time points for each arm, respectively.||units on a scale||Standard Deviation|Mean
769038|NCT00708708|Secondary|Amount of Annual Cost for Participants Arising From Out-of-Pocket Payment and Concomitant Medications|Annual costs for participants for treatment with etanercept due to out of pocket payments (included payments which were not reimbursed by the health insurance funds) and concomitant medications was reported per month for costs prior to study and per year for each year in the study up to 5 years. 'By year' analysis was not possible for those participants for whom the data of 1 or more visits was missing.|Prior to study, Year 1, 2, 3, 4, 5|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here ‘n’= participants evaluable at the specified time points for this outcome measure.||Euros||Standard Deviation|Mean
769048|NCT00708708|Secondary|Cumulative Dose of Etanercept Per Year|Cumulative dose of etanercept per year was calculated up to 5 years. 'By year' analysis was not possible for those participants for whom the data of one or more visits was missing.|Year 1, 2, 3, 4, 5|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. 'n' = participants evaluable at the specified time points for this outcome measure.||mg||Standard Deviation|Mean
769039|NCT00708708|Secondary|Average Cost of Treatment by Disease Severity|Average costs for treatment with etanercept up to 5 years was calculated in Euros. Disease severity was categorized as mild (0 to 10 PASI score), moderate (10.1 to 20 PASI score) and severe (20.1 to 72 PASI score) at each year. PASI: Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0= 0% to 6= 90–100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease. 'By year' analysis was not possible for those participants for whom the data of one or more visits was missing.|Year 1, 2, 3, 4, 5|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here ‘n’= participants evaluable at the specified time points for the given disease severities.||Euros||Standard Deviation|Mean
769040|NCT00708708|Secondary|Annual Costs for Treatment With Etanercept|Costs for treatment with etanercept per year up to 5 years was calculated in Euros. 'By year' analysis was not possible for those participants for whom the data of 1 or more visits was missing.|Year 1, 2, 3, 4, 5|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here ‘n’= participants evaluable at the specified time points for this outcome measure.||Euros||Standard Deviation|Mean
769041|NCT00708708|Secondary|Number of Participants With at Least 1 Concomitant Medication|Number of participants taking any non-study medications which were administered during the period of etanercept treatment for the management of an adverse event or for the treatment of any other disease and not plaque psoriasis were reported.|Cycle 1 Week 0 up to Cycle 6 Week 24|Safety analysis set included all participants with available post-baseline safety data.||participants|||Number
769042|NCT00708708|Secondary|Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS)|EQ-5D: participant rated questionnaire to assess health-related quality of life. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Score of each domain is transformed into a single VAS score using formula developed by Greiner et al and results in a total score range of 0 to 100, where higher score indicates a better health state.|Week 0, 12, 24 of Cycle 1 to 6|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here, ’n’=number of participants evaluable for this measure at the specified time points.||units on a scale||Standard Deviation|Mean
769043|NCT00708708|Secondary|Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO)|EQ-5D: participant rated questionnaire to assess health-related quality of life. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (extreme problems). Score of each domain is transformed into a single TTO value using formula developed by Greiner et al and results in a total score range -0.205 to 0.999; higher score indicates a better health state.|Week 0, 12, 24 of Cycle 1 to 6|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here, ’n’=number of participants evaluable for this measure at the specified time points.||units on a scale||Standard Deviation|Mean
769044|NCT00708708|Secondary|Dermatology Life Quality Index (DLQI) Score|DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst).|Week 0, 12, 24 of Cycle 1 to 6|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here, ’n’=number of participants evaluable for this measure at the specified time points.||units on a scale||Standard Deviation|Mean
769045|NCT00708708|Secondary|Patient’s Global Assessment of Disease Activity (PatGA)|Participants were asked to rate the severity of their disease activity on a 6-point scale, where 0 = no activity and 5 = severe or maximum activity.|Week 0, 12, 24 of Cycle 1 to 6|Efficacy analysis set included all participants >=18 years of age, confirmed diagnosis of plaque psoriasis, had not received treatment with etanercept previously and had post baseline documentations. Here, ’n’=number of participants evaluable for this measure at the specified time points.||units on a scale||Standard Deviation|Mean
769046|NCT00708708|Secondary|Percentage of Time on Treatment Over Entire Period|Percentage of time on etanercept treatment over entire treatment period was calculated. It was calculated as 100% * ([Date of last application - Date of first application + 1] - Sum of duration of drug-free intervals [days])/(Date of last application - Date of first application + 1).|Cycle 1 up to Cycle 6|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||percentage of entire treatment period||Standard Deviation|Mean
769047|NCT00708708|Secondary|Percentage of Time on Treatment in First Year|Percentage of time on etanercept treatment for first year was calculated. It was calculated as 100% * (365- sum of durations of drug-free intervals in the first year)/365. Analysis was not possible for participants with missing data of visit 1 (Week 0) of Cycle 1.|Year 1|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||percentage of first year||Standard Deviation|Mean
769071|NCT00708942|Secondary|Incidence of Patients With Adverse Events||3 months|All patients treated||percentage of no of patients analyzed|||Number
769072|NCT00708942|Secondary|Eradication of HPV|High risk HPV|6 months|Patients who were positive for high risk HPV at baseline||percentage of no. of patients analyzed|||Number
769049|NCT00708708|Secondary|Number of Injections Per Year|Number of etanercept injections per year were calculated up to 5 years. 'By year' analysis was not possible for those participants for whom the data of one or more visits was missing.|Year 1, 2, 3, 4, 5|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. 'n'= participants evaluable at the specified time points for this outcome measure.||injections||Standard Deviation|Mean
769050|NCT00708708|Secondary|Patient Global Assessment of Efficacy|Participant assessed the effectiveness of etanercept treatment at the end (Week 24) of each cycle as very good, good, moderate, and insufficient.|Week 24 of Cycle 1 to 6|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here 'n'= number of participants evaluable at the end of the given cycles for this outcome measure.||participants|||Number
769051|NCT00708708|Secondary|Physician Global Assessment of Efficacy|Physician assessed the effectiveness of etanercept treatment at the end (Week 24) of each cycle as very good, good, moderate, and insufficient.|Week 24 of Cycle 1 to 6|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here 'n'= number of participants evaluable at the end of the given cycles for this outcome measure.||participants|||Number
769052|NCT00708708|Secondary|Static Physician Global Assessment (sPGA) of Disease Activity|Static physician global assessment (sPGA) of disease activity was assessed as 0 (no psoriasis) to 5 (severe disease) based on severity of induration, scaling, and erythema across all psoriatic lesions.|Week 0, 12, 24 of Cycle 1 to 6|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. 'n'= participants evaluable for this measure at the specified time points.||units on a scale||Standard Deviation|Mean
769053|NCT00708708|Secondary|Percentage of Body Surface Area (BSA) Affected by Psoriasis|Percentage of body surface area affected by psoriasis was estimated using the palm method: one of the participant’s palm to proximal interphalangeal and thumb = 1% of total BSA. Regions of the body were assigned specific number of palms with percentage [Head and neck = 10% (10 palms), upper extremities = 20% (20 palms), Trunk (axillae and groin) = 30% (30 palms), lower extremities (buttocks) = 40% (40 palms)]. The total BSA affected was the summation of individual regions affected. The results of this outcome measure was summarized separately for participants without drug-free interval, participants with drug-free interval and remaining participants, as per planned analysis.|Week 0, 12, 24 of Cycle 1 to 6|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here 'n' = participants evaluable for this measure at the specified time points for each arm, respectively.||percentage of BSA||Standard Deviation|Mean
769054|NCT00708708|Secondary|Psoriasis Area and Severity Index (PASI) Score|Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent (%) area of skin involved was estimated: 0= 0% to 6= 90–100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease. PASI score at Week 0 of each cycle signifies the disease activity at the time of resumption of etanercept therapy.|Week 0, 12, 24 of Cycle 1 to 6|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here 'n' = participants evaluable for this measure at the specified time points.||units on a scale||Standard Deviation|Mean
769055|NCT00708708|Primary|Duration of Drug-Free Interval Prior to Treatment Cycle 6|Average duration of participant's drug-free interval between the end of treatment Cycle 5 and Cycle 6 was reported in weeks. Duration of drug-free interval was computed as: (date of start of new treatment cycle minus date of last application of etanercept prior to drug free interval plus 1) divided by 7 and it was determined for only those participants who had information available regarding drug-free interval.|Cycle 5 Week 24 up to Cycle 6 Week 0|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here ‘N’ (number of participants analyzed) = participants evaluable for this outcome measure.||weeks||95% Confidence Interval|Mean
769056|NCT00708708|Primary|Duration of Drug-Free Interval Prior to Treatment Cycle 5|Average duration of participant's drug-free interval between the end of treatment Cycle 4 and Cycle 5 was reported in weeks. Duration of drug-free interval was computed as: (date of start of new treatment cycle minus date of last application of etanercept prior to drug free interval plus 1) divided by 7 and it was determined for only those participants who had information available regarding drug-free interval.|Cycle 4 Week 24 up to Cycle 5 Week 0|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here ‘N’ (number of participants analyzed) = participants evaluable for this outcome measure.||weeks||95% Confidence Interval|Mean
769057|NCT00708708|Primary|Duration of Drug-Free Interval Prior to Treatment Cycle 4|Average duration of participant's drug-free interval between the end of treatment Cycle 3 and Cycle 4 was reported in weeks. Duration of drug-free interval was computed as: (date of start of new treatment cycle minus date of last application of etanercept prior to drug free interval plus 1) divided by 7 and it was determined for only those participants who had information available regarding drug-free interval.|Cycle 3 Week 24 up to Cycle 4 Week 0|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here ‘N’ (number of participants analyzed) = participants evaluable for this outcome measure.||weeks||95% Confidence Interval|Mean
769073|NCT00708942|Primary|Complete Response Rate|"Based on histology, cytology and HPV status. Complete response is defined as normal pathology, normal cytology and negative HPV."|6 month|Per protocol population. Patients with major protocol violations excluded.||percentage of no. of patients analyzed|||Number
769058|NCT00708708|Primary|Duration of Drug-Free Interval Prior to Treatment Cycle 3|Average duration of participant's drug-free interval between the end of treatment Cycle 2 and Cycle 3 was reported in weeks. Duration of drug-free interval was computed as: (date of start of new treatment cycle minus date of last application of etanercept prior to drug free interval plus 1) divided by 7 and it was determined for only those participants who had information available regarding drug-free interval.|Cycle 2 Week 24 up to Cycle 3 Week 0|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post-baseline documentations. Here ‘N’ (number of participants analyzed)= participants evaluable for this outcome measure.||weeks||95% Confidence Interval|Mean
769059|NCT00708708|Primary|Duration of Drug-Free Interval Prior to Treatment Cycle 2|Average duration of participant's drug-free interval between the end of treatment Cycle 1 and Cycle 2 was reported in weeks. Duration of drug-free interval was computed as: (date of start of new treatment cycle minus date of last application of etanercept prior to drug free interval plus 1) divided by 7 and it was determined for only those participants who had information available regarding drug-free interval.|Cycle 1 Week 24 up to Cycle 2 Week 0|Efficacy analysis set: all participants greater than or equal to (>=) 18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here ‘N’ (number of participants analyzed)= participants evaluable for this outcome measure.||weeks||95% Confidence Interval|Mean
769060|NCT00708721|Secondary|Number of Participants With Adverse Events|NCI CTCAE version 3.0 will be used to assess adverse events. The number of participants experiencing adverse events and the number of adverse events per patient will be documented through the course of study.|To 30 days after end of treatment or until full resolution.|All participants experienced at least 1 adverse event (100% of the patient population; 11/11 participants)||participants experiencing adverse events|||Number
769061|NCT00708721|Secondary|The Effect of Low Dose Daily Oral Clofarabine on miRNA and mRNA Expression Patterns in Patients With MDS|Assessment of potential change in miRNA and mRNA genetic expression patterns in patients following administration of low dose daily clofarabine.|through end of treatment|Data were not collected and the outcome measure was not analyzed|||||
769062|NCT00708721|Secondary|The Effect of Low Dose Daily Oral Clofarabine on Global Methylation in Patients With MDS.|Potential genomic changes following low dose daily oral clofarabine administration will be assessed.|through end of treatment|Data were not collected and the outcome measure was not analyzed|||||
769063|NCT00708721|Secondary|Response of MDS Patients Treated With Low Dose Daily Oral Clofarabine.|Stable disease is defined as failure to achieve at least PR, but no evidence of progression for > 8 weeks.|approximately 4 years|Of 11 patients, 9 were evaluable for response. Two patients had stable disease responses.||Participants|||Count of Participants
769064|NCT00708721|Secondary|Time to Progression to Acute Myeloid Leukemia (AML)|Longest documented duration of time until progression to AML.|approximately 4 years|Cycles are 28 days long. Analysis assessed the longest number of cycles completed on study until progression to AML.||cycles|||Number
769065|NCT00708721|Primary|The Overall Response Rate in Response to Low Dose Daily Oral Clofarabine in Patients With High Risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia (Dysplastic Type).|Response rate was measured as complete, partial and hematologic improvement by modified IWG criteria. For complete remission the following must be present for four weeks in a bone marrow aspirate and biopsy: <5% myeloblasts, normal maturation of all cell lines, persisted dysplasia. Peripheral blood counts need to be hemoglobin >11 g/dL, neutrophils >1000/mm3, platelets>100000/mm3, blasts 0%. Partial remission requires all criteria for complete remission except blasts decreased by >50% over pretreatment. Stable disease is defined as failure to achieve at least partial remission, but no evidence of progression for > 8 weeks. Failure is defined as death during tre3atment or disease progression characterized by worsening of cytopenias, increase in percentage of bone marrow blasts, or progression to a more advanced MDS FAB subtype than pretreatment.|4 weeks|Two patients were not eligible for analysis.||participants who experienced a response|||Number
769066|NCT00708721|Primary|Number of Participants Who Experienced a Dose-Limiting Toxicity|Dose-limiting toxicity was defined as any nonhematologic toxicity grade 3 or greater except for alopecia or nausea (which may be of grade 4 severity), or any grade 4 hematologic toxicity lasting more than 28 days after the last day of therapy.|28 days after the first admistration of oral clofarabine|9 out of 11 participants were evaluable for this outcome.||participants who experienced a DLT|||Number
769067|NCT00708734|Primary|Gait and Balance Measures|Assessment of balance using the (sensory organization test, limits of stability, berg balance) and gait using 3D motion capture.|5 months|The purpose of this pilot study was to evaluate the feasibilty of a structured, group exercise program in this population. Only 3 of 10 participants completed the study, due to high attrition, the project was considered unfeasible and data was not analysis.|||||
769068|NCT00708851|Secondary|The Difference in Number and Severity of Treatment-related Adverse Reactions Between Conditions.|Number of subjects who experienced and adverse reaction due to UVB + LCD, versus number of subjects who experienced an adverse reaction due to UVB therapy alone.|12 weeks of treatment|Data were analyzed using an intent-to-treat (ITT) population. All enrolled patients were included in the analysis. Missing scores were filled in by last observation carried forward method. All statistical tests were two-sided and used a level of significance of alpha = 0.05.||participants|||Number
769069|NCT00708851|Primary|The Difference in Bilateral Static Physician's Global Assessment (sPGA) Scores, and Erythema, Scaling, and Induration (ESI) Scores of Bilateral Target Lesion Scores Across Visits for Each Condition and Between Conditions.|Twelve (12) participants were followed over a 12-week treatment period. Treatment was administered bilaterally as they applied LCD solution to one half of their body while receiving full-body NB-UVB light therapy. The difference in their sPGA, and ESI scores of bilateral target lesions were measured across all visits. PGA scores are calculated using a 6-point scale from 0 (clear) to 5 (very severe). Erythema, induration and scaling scores use a 5-point scale from 0 (none) to 4 (very severe).|12 weeks of treatment|Data were analyzed using an intent-to-treat (ITT) population. All enrolled patients were included in the analysis. Missing scores we filled in by last observation carried forward method. All statistical tests were two-sided and used a level of significance of alpha = 0.05.||percent improvement from baseline||Full Range|Mean
769070|NCT00708877|Primary|Transplant-related Mortality|Determined mortality-related transplant outcomes.|2 years|Entire cohort was used for analysis.||participants|||Number
769074|NCT00709059|Primary|Number of Study Participants Who Had a Virological Response (VR) at Week-72|"VR was defined as the absence of Hepatitis C virus Ribonucleic Acid (HCV RNA) in a qualitative Polymerase Chain Reaction (PCR) test.
Participants who dropped out or were withdrawn from treatment were considered not to respond."|Treatment Week 72|Full Analysis Set (FAS)was analyzed. FAS consisted of all participants in the intent-to-treat population wih non-missing viral response at Week 72.||Participants|||Number
769075|NCT00709098|Other Pre-specified|Average Inhalation Time|Average inhalation time of iloprost during the double-blind period (i.e., the sum of the duration of each inhalation divided by the number of inhalations during the double-blind period)|12 weeks|All treated population||minutes||Standard Deviation|Mean
769076|NCT00709098|Primary|Patients With Adverse Events Leading to Premature Discontinuation of Study Drug|Number of patients with adverse events leading to discontinuation of study treatment|Double-blind period: from the first inhalation of study drug to discontinuation. Open-label period: from the start of open-label medication to discontinuation, mean duration of exposure was 284.5 days.|||participants|||Number
769077|NCT00709098|Primary|Adverse Events Leading to Premature Discontinuation of Study Drug|Number of adverse events leading to discontinuation of study treatment|Double-blind period: from the first inhalation of study drug to discontinuation. Open-label period: from the start of open-label medication to discontinuation, mean duration of exposure was 284.5 days.|Safety population||adverse events|||Number
769078|NCT00709098|Primary|Treatment-emergent Serious Adverse Events|Number of serious adverse events|Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication, mean duration of exposure was 284.5 days.|Safety population||serious adverse events|||Number
769079|NCT00709098|Primary|Treatment-emergent Adverse Events|Number of adverse events|Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication, mean duration of exposure was 284.5 days.|Safety population||adverse events|||Number
769080|NCT00709111|Secondary|Drug Adherence Assessed as Number of Missed Doses Over a 4-day Recall|Self-reported MVC adherence data were based on a four-day (8 expected doses) recall. Based on the wording of the Self Report case report form (CRF), participants reporting that they were currently taking MVC that then failed to complete the record of the number of missed doses were assumed to have no missed doses to report. Missing adherence assessments at a time point of interest were ignored and only those participants completing an adherence assessment at least one time point of interest were included.|At weeks 4, 12, and 24|As-treated: Participants who initiated treatment were included. Follow-up while receiving MVC without change in background regimen were included.||doses missed||Full Range|Median
769081|NCT00709111|Secondary|Proportion of Participants With Detectable HIV-1 Viremia as Measured by Single Copy Assay (SCA)|A subject was considered detectable at a specific week if HIV-1 RNA by SCA >=1 copy/ml.|At weeks -1 (pre-entry), 0 (entry), 12, 22, 24, and 36|As-treated: Participants who initiated treatment were included. Through week 24, follow-up while receiving MVC without change in background regimen were included. For week 36, only results obtained while receiving background regimen were included. One subject who had a large rise (blip) in viral load at week 24 was excluded.||proportion of participants|||Number
769082|NCT00709111|Secondary|Change in D-dimer|Change was calculated as week 48 result (average of week 46 and week 48) minus the week 24 result (average of the week 22 and week 24 values).|From week 24 to week 48|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with either a week 46 result or a week 48 result obtained while receiving background regimen were included.||mcg/ml||90% Confidence Interval|Median
769083|NCT00709111|Secondary|Change in ICAM-1, Plasma P-selectin, sTNFRII, and MMP-9|Change was calculated as week 48 result (average of week 46 and week 48) minus the week 24 result (average of the week 22 and week 24 values).|From week 24 to week 48|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with either a week 46 result or a week 48 result obtained while receiving background regimen were included.||ng/ml||90% Confidence Interval|Median
769084|NCT00709111|Secondary|Change in IL-6, MCP-1, MCP-2, and Plasma CD40L|Change was calculated as week 48 result (average of week 46 and week 48) minus the week 24 result (average of the week 22 and week 24 values).|From week 24 to week 48|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with either a week 46 result or a week 48 result obtained while receiving background regimen were included.||pg/ml||90% Confidence Interval|Median
769085|NCT00709111|Secondary|Change in Hs-CRP|Change was calculated as week 48 result (average of week 46 and week 48) minus the week 24 result (average of the week 22 and week 24 values).|From week 24 to week 48|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with either a week 46 result or a week 48 result obtained while receiving background regimen were included.||mg/dl||90% Confidence Interval|Median
769086|NCT00709111|Secondary|Change in D-dimer|Change was calculated as week 36 result minus the week 24 result (average of the week 22 and week 24 values).|From week 24 to week 36|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with a week 36 result obtained while receiving background regimen were included.||mcg/ml||90% Confidence Interval|Median
769087|NCT00709111|Secondary|Change in ICAM-1, Plasma P-selectin, sTNFRII, and MMP-9|Change was calculated as week 36 result minus the week 24 result (average of the week 22 and week 24 values).|From week 24 to week 36|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with a week 36 result obtained while receiving background regimen were included.||ng/ml||90% Confidence Interval|Median
769088|NCT00709111|Secondary|Change in IL-6, MCP-1, MCP-2, and Plasma CD40L|Change was calculated as week 36 result minus the week 24 result (average of the week 22 and week 24 values).|From week 24 to week 36|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with a week 36 result obtained while receiving background regimen were included.||pg/ml||90% Confidence Interval|Median
769089|NCT00709111|Secondary|Change in Hs-CRP|Change was calculated as week 36 result minus the week 24 result (average of the week 22 and week 24 values).|From week 24 to week 36|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with a week 36 result obtained while receiving background regimen were included.||mg/dl||90% Confidence Interval|Median
769090|NCT00709111|Secondary|Change in D-dimer|Change was calculated as the week 24 result (average of the week 22 and week 24 values) minus the baseline result (average of pre-entry and entry values).|From baseline to week 24|As-treated: Only participants with either a week 22 result or a week 24 result obtained while receiving MVC without change in background regimen were included.||mcg/ml||90% Confidence Interval|Median
769091|NCT00709111|Secondary|Change in Intercellular Cell Adhesion Molecule (ICAM)-1, Plasma P-selectin, Soluble TNFRII (sTNFRII), and Matrix Metalloproteinase (MMP)-9|Change was calculated as the week 24 result (average of the week 22 and week 24 values) minus the baseline result (average of pre-entry and entry values).|From baseline to week 24|As-treated: Only participants with either a week 22 result or a week 24 result obtained while receiving MVC without change in background regimen were included.||ng/ml||90% Confidence Interval|Median
769092|NCT00709111|Secondary|Change in Interleukin (IL)-6, Monocyte Chemoattractant Protein (MCP)-1, MCP-2, and Plasma CD40 Ligand (CD40L)|Change was calculated as the week 24 result (average of the week 22 and week 24 values) minus the baseline result (average of pre-entry and entry values).|From baseline to week 24|As-treated: Only participants with either a week 22 result or a week 24 result obtained while receiving MVC without change in background regimen were included.||pg/ml||90% Confidence Interval|Median
769093|NCT00709111|Secondary|Change in High Sensitivity C-reactive Protein (Hs-CRP)|Change was calculated as the week 24 result (average of the week 22 and week 24 values) minus the baseline result (average of pre-entry and entry values).|From baseline to week 24|As-treated: Only participants with either a week 22 result or a week 24 result obtained while receiving MVC without change in background regimen were included.||mg/dl||90% Confidence Interval|Median
769094|NCT00709111|Secondary|Change in Soluble CD14|Change was calculated as week 48 result (average of week 46 and week 48) minus the week 24 result (average of the week 22 and week 24 values). Soluble CD14 is a marker of gut microbial translocation.|From week 24 to week 48|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with either a week 46 result or a week 48 result obtained while receiving background regimen were included.||mcg/ml||90% Confidence Interval|Median
769095|NCT00709111|Secondary|Change in Soluble CD14|Change was calculated as week 36 result minus the week 24 result (average of the week 22 and week 24 values). Soluble CD14 is a marker of gut microbial translocation.|From week 24 to week 36|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with a week 36 result obtained while receiving background regimen were included.||mcg/ml||90% Confidence Interval|Median
769096|NCT00709111|Secondary|Change in Soluble CD14|Change was calculated as the week 24 result (average of the week 22 and week 24 values) minus the baseline result (average of pre-entry and entry values). Soluble CD14 is a marker of gut microbial translocation.|From baseline to week 24|As-treated: Only participants with either a week 22 result or a week 24 result obtained while receiving MVC without change in background regimen were included.||mcg/ml||90% Confidence Interval|Median
769097|NCT00709111|Secondary|Change in Percentage of CD8+ T-cells That Are: naïve (%CD45RA+CCR7+), Central Memory (%CD45RA-CCR7+), Effector Memory (%CD45RA-CCR7-), Effector (%CD45RA+CCR7-), %HLA-DR+CD38+, %CD38+, %Ki67+, %caspase3+, %Bcl-2-, and %CD57+|Change was calculated as week 48 result (average of week 46 and week 48) minus the week 24 result (average of the week 22 and week 24 values).|From week 24 to week 48|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with either a week 46 result or a week 48 result obtained while receiving background regimen were included.||% of CD8+ T-cells||90% Confidence Interval|Median
769098|NCT00709111|Secondary|Change in Percentage of CD4+ T-cells That Are: naïve (%CD45RA+CCR7+), Central Memory (%CD45RA-CCR7+), Effector Memory (%CD45RA-CCR7-), Effector (%CD45RA+CCR7-), %HLA-DR+CD38+, %CD38+, %Ki67+, %caspase3+, %Bcl-2-, and %CD57+|Change was calculated as week 48 result (average of week 46 and week 48) minus the week 24 result (average of the week 22 and week 24 values).|From week 24 to week 48|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with either a week 46 result or a week 48 result obtained while receiving background regimen were included.||% of CD4+ T-cells||90% Confidence Interval|Median
769099|NCT00709111|Secondary|Change in Percentage of CD8+ T-cells That Are: naïve (%CD45RA+CCR7+), Central Memory (%CD45RA-CCR7+), Effector Memory (%CD45RA-CCR7-), Effector (%CD45RA+CCR7-), %HLA-DR+CD38+, %CD38+, %Ki67+, %caspase3+, %Bcl-2-, and %CD57+|Change was calculated as week 36 result minus the week 24 result (average of the week 22 and week 24 values).|From week 24 to week 36|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with a week 36 result obtained while receiving background regimen were included.||% of CD8+ T-cells||90% Confidence Interval|Median
769100|NCT00709111|Secondary|Change in Percentage of CD4+ T-cells That Are: naïve (%CD45RA+CCR7+), Central Memory (%CD45RA-CCR7+), Effector Memory (%CD45RA-CCR7-), Effector (%CD45RA+CCR7-), %HLA-DR+CD38+, %CD38+, %Ki67+, %caspase3+, %Bcl-2-, and %CD57+|Change was calculated as week 36 result minus the week 24 result (average of the week 22 and week 24 values).|From week 24 to week 36|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with a week 36 result obtained while receiving background regimen were included.||% of CD4+ T-cells||90% Confidence Interval|Median
769101|NCT00709111|Secondary|Change in Percentage of CD8+ T-cells That Are: naïve (%CD45RA+CCR7+), Central Memory (%CD45RA-CCR7+), Effector Memory (%CD45RA-CCR7-), Effector (%CD45RA+CCR7-), %HLA-DR+CD38+, %CD38+, %Ki67+, %caspase3+, %Bcl-2-, and %CD57+|Change was calculated as the week 24 result (average of the week 22 and week 24 values) minus the baseline result (average of pre-entry and entry values).|From baseline to week 24|As-treated: Only participants with either a week 22 result or a week 24 result obtained while receiving MVC without change in background regimen were included.||% of CD8+ T-cells||90% Confidence Interval|Median
769102|NCT00709111|Secondary|Change in Percentage of CD4+ T-cells That Are: naïve (%CD45RA+CCR7+), Central Memory (%CD45RA-CCR7+), Effector Memory (%CD45RA-CCR7-), Effector (%CD45RA+CCR7-), %HLA-DR+CD38+, %CD38+, %Ki67+, %caspase3+, %Bcl-2-, and %CD57+|Change was calculated as the week 24 result (average of the week 22 and week 24 values) minus the baseline result (average of pre-entry and entry values).|From baseline to week 24|As-treated: Only participants with either a week 22 result or a week 24 result obtained while receiving MVC without change in background regimen were included.||% of CD4+ T-cells||90% Confidence Interval|Median
769116|NCT00709124|Secondary|ICU Delirium||Number of days with delirium in the ICU||||||
769103|NCT00709111|Secondary|Number of Subjects Who Experience a Grade 2, 3 or 4 Signs and Symptoms, Grade 3 or 4 Laboratory Abnormalities, or Death.|Events with date of onset or specimen date prior to first dose of MVC or after the last dose of MVC were excluded. Signs and symptoms with a date of onset the same as the first dose of MVC were excluded if confirmed by the site to be before the first dose. Lab abnormalities with the date of specimen the same as the date of the first dose of MVC were excluded on the assumption that the specimen was drawn before the first dose. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables, where Grade 1=Mild, 2=Moderate, 3=Severe, 4=Potentially life-threatening.|From baseline through week 24|As-treated: Participants who initiated treatment were included. Follow-up while receiving MVC without change in background regimen were included.||participants|||Number
769104|NCT00709111|Secondary|Change in CD4 Percentage|Change was calculated as week 48 CD4 percentage (average of week 46 and week 48) minus the week 24 CD4 percentage (average of the week 22 and week 24 values).|From week 24 to week 48|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with either a week 46 CD4 percentage or a week 48 CD4 percentage obtained while receiving background regimen were included.||% of total lymphocytes||90% Confidence Interval|Median
769105|NCT00709111|Secondary|Change in CD4 Percentage|Change was calculated as week 36 CD4 percentage minus the week 24 CD4 percentage (average of the week 22 and week 24 values).|From week 24 to week 36|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with a week 36 CD4 percentage obtained while receiving background regimen were included.||% of total lymphocytes||90% Confidence Interval|Median
769106|NCT00709111|Secondary|Change From Within-subject Pre-treatment CD4 Percentage Slopes to Corresponding Within-subject CD4 Percentage Slopes From Baseline Through Week 24|The estimated mean change in slopes was summarized across the population by using generalized estimating equations. Pre-treatment CD4 percentage (from at least 48 weeks prior to study entry) were recorded at screening from patient source documentation. Baseline was defined as the average of pre-entry and entry values. Week 24 was defined as the average of the week 22 and week 24 values.|From pre-treatment through week 24|As-treated: Participants with CD4 percentage available at least through visit week 22 while receiving MVC without change in background regimen were included. Four of these subjects did not have pre-treatment (from at least 48 weeks prior to study entry) CD4 percentage results available.||% of total lymphocytes/year||90% Confidence Interval|Mean
769107|NCT00709111|Secondary|Within-subject CD4 Percentage Slopes|The estimated mean slope was summarized across the population by using generalized estimating equations. Baseline was defined as the average of pre-entry and entry values. Week 24 was defined as the average of the week 22 and week 24 values.|From baseline through week 24|As-treated: Participants with CD4 percentage available at least through visit week 22 while receiving MVC without change in background regimen were included. Four of these subjects did not have pre-treatment (from at least 48 weeks prior to study entry) CD4 percentage results available.||% of total lymphocytes/year||90% Confidence Interval|Mean
769108|NCT00709111|Secondary|Change in CD4 Percentage|Change was calculated as the week 24 CD4 percentage (average of the week 22 and week 24 values) minus the baseline CD4 percentage (average of pre-entry and entry values).|From baseline to week 24|As-treated: Only participants with either a week 22 CD4 percentage or a week 24 CD4 percentage obtained while receiving MVC without change in background regimen were included.||% of total lymphocytes||90% Confidence Interval|Median
769109|NCT00709111|Secondary|Change in CD4+ T-cell Count|Change was calculated as week 48 CD4+ T-cell count (average of week 46 and week 48) minus the week 24 CD4+ T-cell count (average of the week 22 and week 24 values).|From week 24 to week 48|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with either a week 46 CD4+ T-cell count or a week 48 CD4+ T-cell count obtained while receiving background regimen were included.||cells/mm^3||90% Confidence Interval|Median
769110|NCT00709111|Secondary|Change in CD4+ T-cell Count|Change was calculated as week 36 CD4+ T-cell count minus the week 24 CD4+ T-cell count (average of the week 22 and week 24 values).|From week 24 to week 36|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with a week 36 CD4+ T-cell count obtained while receiving background regimen were included.||cells/mm^3||90% Confidence Interval|Median
769111|NCT00709111|Secondary|Change From Within-subject Pre-treatment CD4+ T-cell Count Slopes to Corresponding Within-subject CD4+ T-cell Count Slopes From Baseline Through Week 24|The estimated mean change in slopes was summarized across the population by using generalized estimating equations. Pre-treatment CD4+ T-cell counts (from at least 48 weeks prior to study entry) were recorded at screening from patient source documentation. Baseline was defined as the average of pre-entry and entry values. Week 24 was defined as the average of the week 22 and week 24 values.|From pre-treatment through week 24|As-treated: Participants with CD4+ T-cell counts available at least through visit week 22 while receiving MVC without change in background regimen were included.||cells/mm^3/year||90% Confidence Interval|Mean
769112|NCT00709111|Secondary|Within-subject CD4+ T-cell Count Slopes|The estimated mean slope was summarized across the population by using generalized estimating equations. Baseline was defined as the average of pre-entry and entry values. Week 24 was defined as the average of the week 22 and week 24 values.|From baseline through week 24|As-treated: Participants with CD4+ T-cell counts available at least through visit week 22 while receiving MVC without change in background regimen were included.||cells/mm^3/year||90% Confidence Interval|Mean
769113|NCT00709111|Secondary|Proportion of Participants Achieving a 50-cell Increase in CD4+ T-cell Count|Baseline was defined as the average of pre-entry and entry values. Week 24 was defined as the average of the week 22 and week 24 values.|From baseline to week 24|As-treated: Only participants with either a week 22 CD4+ T-cell count or a week 24 CD4+ T-cell count obtained while receiving MVC without change in background regimen were included.||proportion of participants||90% Confidence Interval|Number
769114|NCT00709111|Primary|Change in CD4+ T-cell Count|Change was calculated as the week 24 CD4+ T-cell count (average of the week 22 and week 24 values) minus the baseline CD4+ T-cell count (average of pre-entry and entry values).|From baseline to week 24|As-treated: Only participants with either a week 22 CD4+ T-cell count or a week 24 CD4+ T-cell count obtained while receiving MVC without change in background regimen were included.||cells/mm^3||90% Confidence Interval|Median
769117|NCT00709124|Secondary|Mean Change in Subject’s Lower Extremity MRC Composite Score From Baseline||At ICU and Hospital discharge||||||
769129|NCT00709124|Primary|Lower Extremity Strength, at Hospital Discharge, of 3 Bilateral Muscle Groups (Pretibial, Triceps Surae, and Quadriceps) Measured Via MMT Using a Composite Medical Research Council (MRC) Score|Range 0 to 30 with higher score better. The composite score is a simple sum of the individual scores from the 3 bilateral muscle groups|At hospital discharge|||units (range 0-30; higher is better)||Standard Deviation|Mean
769130|NCT00709228|Primary|Number of HCV LVL G1 Participants Who Relapsed|Relapse was defined as undetectable Hepatitis C virus-ribonucleic acid (HCV-RNA) at End of Treatment, but detectable HCV-RNA at Follow-up Week 24.|Week 24 of follow-up|The 165 participants analyzed is from the efficacy evaluable population (170) minus 5 subjects who did not have follow-up data.||Participants|||Number
769131|NCT00709319|Primary|Change in Optical Coherence Tomography Central Subfield Thickness From Baseline to 6 Months|Change in thickness is followup thickness minus baseline thickness.|Baseline to 6 months|||participants|||Number
769132|NCT00709319|Primary|Percent of Participants With Change in Visual Acuity From Baseline to Six Months||Baseline to 6 months|||Percentage of Participants||95% Confidence Interval|Number
769133|NCT00709319|Secondary|Surgical Complications From Baseline to Six Months|Including intraoperative and perioperative medical complications. Same subject could have more than one complication|Baseline to 6 months|||Participants|||Number
769134|NCT00709319|Primary|Change in Optical Coherence Tomography Measured Central Subfield Thickness From Baseline|Change in central subfield thickness is followup central subfield retinal thickness minus baseline thickness.|Baseline to 6 Months|||microns||Inter-Quartile Range|Median
769135|NCT00709319|Primary|Visual Acuity|Change in best correct visual acuity letter score from baseline to six months as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale 97, worst 0.|Baseline to 6 months|||Units on a scale||Inter-Quartile Range|Median
769136|NCT00709592|Secondary|Chronic Graft-Versus-Host Disease (GVHD)||2 year GVHD rate|||percentage of participants|||Number
769137|NCT00709592|Secondary|Acute Graft-Versus-Host Disease (GVHD)||2 year rate (%)|||percentage of participant|||Number
769138|NCT00709592|Secondary|Donor Lymphocyte Infusion||2 year rate of DLI|||percentage of participants|||Number
769139|NCT00709592|Secondary|Relapse|Patients with different disease relapses was determined according to current clinical standards based on the disease. For example, AML or MDS relapse is determined by a bone marrow biopsy. Multiple myeloma relapse requires a number of labs and/or biopsy to diagnose such as SPEP, UPEP, immunofixation, serum and urine light chains. In lymphoma disease is followed using CT and/or PET scans.|2 year relapse rate (%)|||Percent patients relapsing|||Number
769140|NCT00709592|Secondary|Event-free Survival||2 years|||percentage of participants|||Number
769141|NCT00709592|Secondary|Treatment Related Mortality||Day 100|||percentage of patients|||Number
769142|NCT00709592|Secondary|Survival||2-year survival rate (%)|||percentage of patient surviving|||Number
769143|NCT00709592|Secondary|Engraftment of Donor Hematopoietic Stem Cells, as Measured by Neutrophil and Platelet Counts||12 day median||||||
769144|NCT00709592|Primary|The Comparison of Functional Immune Reconstitution at 6-9 Months Following Transplant as Measured by Antibody Response to Vaccination With Inactivated Hepatitis A or B Vaccine.|A positive test result will indicate immune reconstitution, while a negative test results will indicate lack of immune reconstitution. Participants not done (ND) will be counted with the negative (Neg).|Up to 9 months following transplant|||participants|||Number
769145|NCT00709618|Secondary|Overall Survival|OS is defined as the time from the start of study treatment to the date of death. In the absence of confirmation of death, survival time was to be censored at the last date the participant was known to be alive. Overall survival was not assessed because the study was terminated due to low screening and a low enrollment rate after 3 years. There were no-survival follow-up visits required.|From the start of study treatment to the date of death, assessed for up to 3 years||||||
769146|NCT00709618|Secondary|Number of Participants With the Indicated Adverse Events Occurring in at Least 5 Participants and Related to the Combination of Lapatinib and Vinorelbine|Qualitative and quantitative toxicities associated with the combination of lapatinib and vinorelbine during the study are those adverse events (AEs) that are judged to be related to the study treatment by the investigator. Those AEs occuring in more than 5 participants in the ITT Population are listed here.|From the start of study medication until disease progression, assessed every 4 weeks for up to 2 years|ITT Population||participants|||Number
769147|NCT00709618|Secondary|Time to Progression (TTP), as Assessed by the Investigator|TTP is defined as the time from the start of treatment until the earliest date of disease progression (a >=20% increase in the sum of the LD of TLs, taking as a reference the smallest LD recorded since treatment started or the appearance of >=1 new lesions) or death due to breast cancer, if sooner.|From the start of study medication until disease progression, assessed every 8 weeks for up to 2 years|ITT Population. Participants who had neither progressed nor died were censored at the date of the last adequate tumor assessment at the time of the cut-off. Censoring is defined as being alive without the event of interest (progression or death).||weeks||95% Confidence Interval|Median
769148|NCT00709618|Secondary|Time to Response, as Assessed by the Investigator|Time to response, for the subset of participants who had a confirmed CR (the disappearance of all TLs) or PR (a >=30% decrease in the sum of the LD of the TLs, taking as a reference the baseline sum LD), is defined as the time from the start of treatment until the first documented evidence of CR or PR (whichever status was recorded first). When tumor response was confirmed at a repeat assessment, the time to response was taken to be the first time that the response was observed.|From the start of study medication until disease progression, assessed every 8 weeks for up to 2 years|ITT Population. Only participants with a confirmed CR/PR were assessed for duration of response. To be assigned a status of PR/CR, a confirmatory disease assessment (including bone scan/positron emission tomography scan documenting that progression/ new lesions hasn't occurred) had to be performed >=4 weeks after response criteria were first met.||weeks||95% Confidence Interval|Median
769159|NCT00709761|Secondary|Time to Response (TTR)|TTR was defined for the subset of participants who showed a confirmed CR or PR, as the time from the start of treatment until the first documented evidence of CR or PR (whichever status was recorded first).|Start of treatment to first documented response (CR or PR) (up to Week 131)|ITT Population. Only those participants experiencing a CR or a PR were analyzed.||weeks||95% Confidence Interval|Median
769149|NCT00709618|Secondary|Duration of Response, as Assessed by the Investigator|Duration of response, for the subset of participants who had a confirmed CR (the disappearance of all TLs) or PR (a >=30% decrease in the sum of the LD of the TLs, taking as a reference the baseline sum LD), is defined as the time from the first documented evidence of CR or PR until the first documented sign of disease progression (a >=20% increase in the sum of the LD of TLs, taking as a reference the smallest LD recorded since treatment started or the appearance of >=1 new lesions) or death due to any cause, if sooner.|From the start of study medication until disease progression, assessed every 8 weeks for up to 2 years|ITT Population. Only participants with a confirmed CR/PR were assessed for duration of response. To be assigned a status of PR/CR, a confirmatory disease assessment (including bone scan/positron emission tomography scan documenting that progression/ new lesions hasn't occurred) had to be performed >=4 weeks after response criteria were first met.||weeks||95% Confidence Interval|Median
769150|NCT00709618|Secondary|Progression-Free Survival (PFS), as Assessed by the Investigator|PFS is defined as the time from the start of treatment until the earliest date of disease progression (PD) or death due to any cause, if sooner. PD is defined as at least a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.|From the start of study medication until disease progression, assessed every 8 weeks for up to 2 years|ITT Population. Participants who had neither progressed nor died were censored at the date of the last adequate tumor assessment at the time of the cut-off. Censoring is defined as being alive without the event of interest (progression or death).||weeks||95% Confidence Interval|Median
769151|NCT00709618|Primary|Number of Participants With Overall Response (OR), as Assessed by the Investigator|OR is defined as the number of participants achieving either a confirmed complete response (CR: the disappearance of all target lesions [TLs]) or partial response (PR: a >=30% decrease in the sum of the longest diameter [LD] of the TLs, taking as a reference the baseline sum LD) as assessed by the investigator as the best OR. The best OR is the best response recorded from the start of treatment until disease progression (PD: a >=20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since treatment started or the appearance of >=1 new lesions)/recurrence.|From the start of study medication until disease progression, assessed every 8 weeks for up to 2 years|Intent-to-Treat (ITT) Population: participants who received >=1 dose of investigational product. To be assigned a status of PR/CR, a confirmatory disease assessment (including bone scan/positron emission tomography scan documenting that progression/ new lesions hasn't occurred) had to be performed >=4 weeks after response criteria were first met.||participants|||Number
769152|NCT00709722|Secondary|Treatment Days With Corticosteroids of <= 7.5 mg/Day|"Entry to the study was permitted for patients with doses of oral corticosteroids (OCS) of <= 1.0 mg/kg/day (maximum dose 80 mg/day).
OCS dosage was maintained, decreased or increased according to the response to DSG.
The number of days on which the OCS dose was <= 7.5 mg/day was counted in each cycle."|1st and 9th Cycle|ITT population||Days||Full Range|Mean
769153|NCT00709722|Secondary|SELENA-SLEDAI Score|The “Safety of Estrogen in Lupus Erythematosus National Assessment – systemic lupus erythematosus disease activity index' (SELENA-SLEDAI) document the current activity of SLE/LN. It contains 24 items (descriptors), which are differently weighed. The score has a total range of 0 - 105. As a maximum 105 score points can be reached meaning the worst disease activity.|Screening, the last day of Cycles 4, 6 and 9, up to 27 weeks|ITT population||Score on a scale||Full Range|Mean
769154|NCT00709722|Primary|Complete and Partial Response Rate|A four-point scale was defined: complete response (CR), partial response (PR), stable disease (SD) or treatment failure (TF). The response criteria were defined prior to the start of the study: for a CR, PR or SD prednisone had to be decreased to <= 7.5 mg/day, a higher dosage was automatically classified as TF. The presence of urinary erythrocyte or granular casts excluded CR. As the baseline activity of every patient is different, it was necessary to define baseline proteinuria (g/24 h) or kidney function (estimated glomerular filtration rate) as the reference value for the definition of response for every patient individually. The baseline was defined as the renal function and proteinuria level before the onset of the recent LN flare which qualified the patient for the study. Response was determined as the ratio of the proteinuria or kidney function at cycle 4, 6 or 9 to the baseline values of the individual patient.|Screening, Day 14 of Cycles 4, 6 and 9, up to 27 weeks|ITT population||Percentage of participants|||Number
769155|NCT00709735|Secondary|Change From Baseline in the Impact of Event Scale-Revised (IES-R) Total Score|IES-R is a 22-item patient reported measure of PTSD symptoms. Each question is answered using a 5-point scale where 0=not at all to 4=extremely for a total possible score of 0 to 88. Lower scores represent less severe symptoms and higher scores representing more severe symptoms. IES-R change scores were calculated by subtracting the Day 2 IES-R total score from the Day 8 IES-R total score. A negative change from Baseline indicates improvement of symptoms and a positive change from Baseline indicates a worsening of symptoms.|Day 2 (Baseline ) and Day 8|All randomized participants who completed the study.||score on a scale||Standard Deviation|Mean
769156|NCT00709735|Primary|Physiological Posterior Probability of Posttraumatic Stress Disorder (PTSD) as Determined From Psychophysiologic Responses During Script-Driven Traumatic Memory Recollection|The posterior probability of developing PTSD was determined for each participant from a composite of psychophysiological responses during script-driven imagery of traumatic combat events that included assessments of heart rate response in beats per minute, skin conductance response in microSiemens, and corrugator and left lateral frontalis facial muscle electromyogram (EMG) responses in microVolts. Responses for the two traumatic scripts were averaged and square-root transformed for analysis. Responses during personal traumatic imagery of previously studied individuals with and without current PTSD was used to calculate each participant’s posterior probability of being classified as PTSD.|Day 8|All randomized participants who completed the study.||percent probability||Standard Deviation|Mean
769157|NCT00709761|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time from the start of treatment until the earliest date of disease progression or death due to any cause, if sooner.|Start of treatment to disease progression or death (up to Week 131)|ITT Population||weeks||95% Confidence Interval|Median
769158|NCT00709761|Secondary|Time to Progression (TTP)|TTP was defined as the interval between the start of treatment until the earliest date of disease progression or death due to breast cancer.|Start of treatment to disease progression or death (up to Week 131)|ITT Population||weeks||95% Confidence Interval|Median
769160|NCT00709761|Secondary|Duration of Response (DOR)|DOR was defined for the subset of participants who showed a confirmed CR or PR, as the time from first documented evidence of CR or PR until the first documented sign of disease progression or death.|First documented response (CR or PR) to disease progression or death (up to Week 131)|ITT Population. Only those participants experiencing a CR or a PR were analyzed.||weeks||95% Confidence Interval|Median
769161|NCT00709761|Secondary|Overall Survival (OS)|OS was defined as the time from the start of treatment until death due to any cause. For participants who did not die, time to death was censored at the time of last contact. OS could not be analyzed because only 13 participants had died as of data cut off, and data were not mature (greater than 75% of the participants were censored for the endpoint).|Start of treatment to death (up to Week 131)|ITT Population|||||
769162|NCT00709761|Primary|Overall Tumor Response (OR)|OR was defined as the percentage of participants experiencing either a confirmed complete response (CR) or a confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.0. CR is defined as the disappearance of all lesions (target and/or non-target). PR is defined as at least a 30% decrease in the sum of the longest dimensions (LD) of target lesions taking as a reference the baseline sum LD, with non-target lesions not increased or absent.|Start of treatment to disease progression or death or discontinuation from study or at least 28 days after last dose (up to Week 131)|Intent-to-Treat (ITT) Population: all participants who received at least one dose of investigational product||percentage of participants|||Number
769163|NCT00709826|Primary|Progression Free Survival|Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline.|Randomization then every other cycle|A 1-sided log rank test was used to achieve 80% power at an α=0.20 significance level to detect a difference of 0.16 between the proportions of patients who were progression free in AP/EG (0.35) and P/EG (0.19) after 9 months; an overall sample size of approximately 110 patients (73 in AP/EG and 37 in P/EG) was randomized in a 2:1 ratio.||Months||95% Confidence Interval|Median
769164|NCT00709826|Secondary|Overall Survival||Randomization then every other cycle|||Months||95% Confidence Interval|Median
769165|NCT00709852|Secondary|Percentage of Lesion Enhancement From Unenhanced to Combined Unenhanced/Enhanced for Gadobutrol and Gadoteridol by Blinded Readers|From the quantitative signal intensity values assessed by the BR, the percentage of lesion enhancement from unenhanced to combined unenhanced/enhanced was calculated.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.||percentage of lesion enhancement||Standard Deviation|Mean
769166|NCT00709852|Secondary|Assessment of the Number of Contrast-enhanced Lesions for Gadobutrol and Gadoteridol by Blinded Readers|Two BRs independently provided the number of contrast-enhanced lesions for gadobutrol and gadoteridol. In cases of disagreement between the readers, an independent adjudicator provided the number of contrast-enhanced lesions. The adjudicator results were used in the analysis in the cases of disagreement between the original readers|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.||lesions||Standard Deviation|Mean
769167|NCT00709852|Secondary|Percentage of Participants for Which Blinded Readers Said Image Quality Was Higher|Percentage of participants for which blinded readers said image quality was higher|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
769168|NCT00709852|Secondary|Comparison of Image Quality Between Gadobutrol and Gadoteridol by Blinded Readers|The BRs evaluated the relative image quality of the gadobutrol-enhanced T1w MR images and the gadoteridol-enhanced T1w MR images in a paired fashion on a 5-point scale where 1 = image on right was worse, 2 = image on right was slightly worse, 3 = both images were the same, 4 = image on right was slightly better, and 5 = image on right was better.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
769169|NCT00709852|Secondary|Diagnostic Confidence for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator|The investigator recorded his/her confidence in diagnosis for the combined unenhanced/gadobutrol-enhanced MR image sets and the combined unenhanced/gadoteridol MR image sets. The degree of confidence was rated on a 4-point scale where 1 = not confident and 4 = very confident.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
769170|NCT00709852|Secondary|Diagnostic Confidence for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The investigator recorded his/her confidence in diagnosis for the unenhanced MR image set and the combined unenhanced/gadoteridol-enhanced MR image sets. The degree of confidence was rated on a 4-point scale where 1 = not confident and 4 = very confident.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
769171|NCT00709852|Secondary|Diagnostic Confidence for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The investigator recorded his/her confidence in diagnosis for the unenhanced MR image set and the combined unenhanced/gadobutrol-enhanced MR image sets. The degree of confidence was rated on a 4-point scale where 1 = not confident and 4 = very confident.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
769172|NCT00709852|Secondary|Diagnostic Confidence for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Average Reader|The BRs recorded his/her confidence in diagnosis for the combined unenhanced/enhanced MR image sets. The degree of confidence was rated on a 4-point scale where 1 = not confident and 4 = very confident. The AR score was the mean of the means of the 3 BRs.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
769173|NCT00709852|Secondary|Diagnostic Confidence for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Average Reader|The BRs recorded his/her confidence in diagnosis for the unenhanced MR image set and the combined unenhanced/enhanced MR image sets. The degree of confidence was rated on a 4-point scale where 1 = not confident and 4 = very confident. The AR score was the mean of the means of the 3 BRs.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
769174|NCT00709852|Secondary|Diagnostic Confidence for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Average Reader|The BRs recorded his/her confidence in diagnosis for the unenhanced MR image set and the combined unenhanced/enhanced MR image sets. The degree of confidence was rated on a 4-point scale where 1 = not confident and 4 = very confident. The AR score was the mean of the means of the 3 BRs.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
769175|NCT00709852|Secondary|Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator|The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (Gadobutrol-enhanced or Gadoteridol-enhanced) correctly excludes malignant lesions as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
769176|NCT00709852|Secondary|Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator|The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (Gadobutrol-enhanced or Gadoteridol-enhanced) correctly detects malignant lesions as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
769177|NCT00709852|Secondary|Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator|The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (Gadobutrol-enhanced or Gadoteridol-enhanced) matches the standard of truth for the presence or absence of malignant lesions.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
769178|NCT00709852|Secondary|Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Majority Reader|The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (Gadobutrol-enhanced or Gadoteridol-enhanced) correctly excludes malignant lesions as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
769179|NCT00709852|Secondary|Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Majority Reader|The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (Gadobutrol-enhanced or Gadoteridol-enhanced) correctly detects malignant lesions as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
769180|NCT00709852|Secondary|Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Majority Reader|The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (Gadobutrol-enhanced or Gadoteridol-enhanced) matches the standard of truth for the presence or absence of malignant lesions.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
769181|NCT00709852|Secondary|Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (unenhanced or Gadoteridol-enhanced) correctly excludes malignant lesions as defined by the independent truth committee.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
769340|NCT00702845|Secondary|Total Dose of recFSH Administered From Day 8 Onwards|Total dose of recFSH (IU) needed from Stimulation Day 8 onwards to reach the criterion for administration of hCG (at least 3 follicles >=17mm).|Stimulation Day 8 of COS cycle up to day of hCG administration (up to a maximum total duration of 19 stimulation days)|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG.||International Unit (IU)||Full Range|Median
769182|NCT00709852|Secondary|Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (unenhanced or Gadoteridol-enhanced) correctly detects malignant lesions as defined by the independent truth committee.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
769183|NCT00709852|Secondary|Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (unenhanced or Gadoteridol-enhanced) matches the standard of truth for the presence or absence of malignant lesions.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
769184|NCT00709852|Secondary|Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Majority Reader|The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (unenhanced or Gadoteridol-enhanced) correctly excludes malignant lesions as defined by the independent truth committee.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
769185|NCT00709852|Secondary|Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Majority Reader|The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (unenhanced or Gadoteridol-enhanced) correctly detects malignant lesions as defined by the independent truth committee|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
769186|NCT00709852|Secondary|Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Majority Reader|The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (unenhanced or Gadoteridol-enhanced) matches the standard of truth for the presence or absence of malignant lesions.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
769187|NCT00709852|Secondary|Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly excludes malignant lesions as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
769188|NCT00709852|Secondary|Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly detects malignant lesions as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
769189|NCT00709852|Secondary|Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) matches the standard of truth for the presence or absence of malignant lesions.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
769341|NCT00702845|Secondary|Total Dose of recFSH Administered|Total dose of recFSH (IU) administered was defined as the total amount of recFSH needed by participants to reach the criterion for administration of hCG (at least 3 follicles >=17mm).|One COS cycle (up to a maximum total duration of 19 stimulation days)|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG.||International Unit (IU)||Full Range|Median
769190|NCT00709852|Secondary|Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader|The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly excludes malignant lesions as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
769191|NCT00709852|Secondary|Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader|The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly detects malignant lesions as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
769192|NCT00709852|Secondary|Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader|The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) matches the standard of truth for the presence or absence of malignant lesions.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
769193|NCT00709852|Secondary|Specificity of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Majority Reader Using T1-weighted (T1w) Images|The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (Gadobutrol-enhanced or Gadoteridol-enhanced) correctly excludes abnormal brain tissue as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
769194|NCT00709852|Secondary|Sensitivity of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Majority Reader Using T1-weighted (T1w) Images|The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (Gadobutrol-enhanced or Gadoteridol-enhanced) correctly detects abnormal brain tissue as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
769195|NCT00709852|Secondary|Accuracy of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Majority Reader Using T1-weighted (T1w) Images|The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (Gadobutrol-enhanced or Gadoteridol-enhanced) matches the standard of truth for the presence or absence of abnormal brain tissue.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
769196|NCT00709852|Secondary|Specificity of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images|The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (unenhanced or Gadoteridol-enhanced) correctly excludes abnormal brain tissue as defined by the independent truth committee.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
769197|NCT00709852|Secondary|Sensitivity of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images|The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (unenhanced or Gadoteridol-enhanced) correctly detects abnormal brain tissue as defined by the independent truth committee.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
769365|NCT00710593|Secondary|Acquisition of HPV-18 DNA by Study Group and Study Visit (Week 48).|Type-specific HPV DNA among subjects who were both HPV DNA negative and HPV sero-negative by study group and study visit at Week 48.|Week 48|||percentage of participants|||Number
775453|NCT00756977|Secondary|Serum Chemistry Results (mg/dL)|Change from Baseline|2 days|Intent-to-treat population: all patients that took any portion of the study preparation.||mg/dL||Standard Deviation|Mean
769198|NCT00709852|Secondary|Accuracy of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images|The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (unenhanced or Gadoteridol-enhanced) matches the standard of truth for the presence or absence of abnormal brain tissue.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
769199|NCT00709852|Secondary|Specificity of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images|The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly excludes abnormal brain tissue as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
769200|NCT00709852|Secondary|Sensitivity of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images|The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly detects abnormal brain tissue as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
769201|NCT00709852|Secondary|Accuracy of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images|The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) matches the standard of truth for the presence or absence of abnormal brain tissue.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
769202|NCT00709852|Secondary|Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator|The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. The accuracy of the clinical investigator diagnoses for the combined unenhanced/gadobutrol-enhanced and the combined unenhanced/gadoteridol-enhanced MR images were evaluated for consistency with the final clinical diagnosis.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.||per. of the exact diagnostic matches|||Number
769203|NCT00709852|Secondary|Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Majority Reader|The majority reader diagnosis was the diagnosis provided by at least 2 of the BRs. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. The accuracy of the majority reader diagnoses for the combined unenhanced/gadobutrol-enhanced and the combined unenhanced/gadoteridol-enhanced MR images were evaluated for consistency with the final clinical diagnosis.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.||per. of the exact diagnostic matches|||Number
769204|NCT00709852|Secondary|Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. The accuracy of the investigator diagnoses for the combined unenhanced/gadoteridol-enhanced and the unenhanced MR images were evaluated for consistency with the final clinical diagnosis.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.||per. of the exact diagnostic matches|||Number
769205|NCT00709852|Secondary|Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Majority Reader|The majority reader diagnosis was the diagnosis provided by at least 2 of the BRs. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. The accuracy of the majority reader diagnoses for the combined unenhanced/gadoteridol-enhanced and the unenhanced MR images were evaluated for consistency with the final clinical diagnosis.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.||per. of the exact diagnostic matches|||Number
769206|NCT00709852|Secondary|Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. The accuracy of the investigator diagnoses for the combined unenhanced/gadobutrol-enhanced and the unenhanced MR images were evaluated for consistency with the final clinical diagnosis.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||per. of the exact diagnostic matches|||Number
769207|NCT00709852|Secondary|Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader|The majority reader diagnosis was the diagnosis provided by at least 2 of the BRs. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. The accuracy of the majority reader diagnoses for the combined unenhanced/gadobutrol-enhanced and the unenhanced MR images were evaluated for consistency with the final clinical diagnosis.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||per. of the exact diagnostic matches|||Number
769208|NCT00709852|Secondary|Scores for Contrast Enhancement, Border Delineation and Internal Morphology for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the combined unenhanced and gadobutrol-enhanced MRIs and the images from the combined unenhanced and gadoteridol-enhanced MRIs. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
769209|NCT00709852|Secondary|Scores for Contrast Enhancement, Border Delineation and Internal Morphology for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the combined unenhanced and gadobutrol-enhanced MRIs and the images from the combined unenhanced and gadoteridol-enhanced MRIs. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
769210|NCT00709852|Secondary|Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the combined unenhanced and gadobutrol-enhanced MRIs and the combined unenhanced and gadoteridol-enhanced MRIs in another to determine the total number of lesions.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.||lesions||Standard Deviation|Mean
769211|NCT00709852|Secondary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the combined unenhanced and gadobutrol-enhanced MRIs and the images from the combined unenhanced and gadoteridol-enhanced MRIs. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
769212|NCT00709852|Secondary|Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the unenhanced MRI and the images from the combined unenhanced and gadoteridol-enhanced MRIs. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
769213|NCT00709852|Secondary|Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the unenhanced MRI and the images from the combined unenhanced and gadoteridol-enhanced MRIs. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
769214|NCT00709852|Secondary|Number of Lesions for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the unenhanced MRI and the images from the combined unenhanced and gadoteridol-enhanced MRIs in another to determine the total number of lesions.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.||lesions||Standard Deviation|Mean
769215|NCT00709852|Secondary|Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the unenhanced MRI and the images from the combined unenhanced and gadoteridol-enhanced MRIs. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
769216|NCT00709852|Secondary|Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the unenhanced MRI and the images from the combined unenhanced and gadobutrol-enhanced MRIs. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
769217|NCT00709852|Secondary|Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the unenhanced MRI and the images from the combined unenhanced and gadobutrol-enhanced MRIs. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
769218|NCT00709852|Secondary|Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the unenhanced MRI and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another to determine the total number of lesions.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||lesions||Standard Deviation|Mean
769219|NCT00709852|Secondary|Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the unenhanced MRI and the images from the combined unenhanced and gadobutrol-enhanced MRIs. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
769220|NCT00709852|Secondary|Percentage of Participants With More Lesions Detected for Combined Unenhanced/Gadobutrol-enhanced MRI or for Combined Unenhanced/Gadoteridol-enhanced MRI by Average Reader|The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the combined unenhanced and gadobutrol-enhanced MRIs in one session and the images from the combined unenhanced and gadoteridol-enhanced MRIs in another and determined the number of lesion from each.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
769221|NCT00709852|Secondary|Percentage of Participants With More Lesions Detected for Combined Unenhanced/Gadoteridol-enhanced MRI or for Unenhanced MRI by Average Reader|The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadoteridol-enhanced MRIs in another and determined the number of lesion from each.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
769222|NCT00709852|Secondary|Percentage of Participants With More Lesions Detected for Combined Unenhanced/Gadobutrol-enhanced MRI or for Unenhanced MRI by Blinded Readers|The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another and determined the number of lesion from each.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
769223|NCT00709852|Secondary|Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Average Reader|The AR analysis used the mean of the values for the 3 blinded readers|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.||lesions||Standard Deviation|Mean
769224|NCT00709852|Secondary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Average Reader|The AR analysis used the mean of the values for the 3 blinded readers.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
769225|NCT00709852|Secondary|Number of Lesions for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Average Reader|The AR analysis used the mean of the values for the 3 blinded readers|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.||lesions||Standard Deviation|Mean
769226|NCT00709852|Secondary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Average Reader|The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
769227|NCT00709852|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Average Reader (AR)|The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
769257|NCT00710021|Secondary|Change in Status for Anti-double-stranded DNA Autoantibody From Baseline to Week 12|Patients with systemic lupus erythematosus (SLE) may have autoantibodies (e.g., self against self) to double-stranded DNA. Double-stranded DNA is one of multiple diagnostic tests for SLE and levels may be associated with disease activity. A positive test for autoantibodies to double-stranded DNA is based on the normal range from the local laboratory. Change in status (+ or -) from baseline is evaluated.|0, Week 12|Modified Intent-to-Treat with available data||Percent of participants|||Number
769228|NCT00709852|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 3 (BR3)|BR3 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
769229|NCT00709852|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 2 (BR2)|BR2 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
769230|NCT00709852|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 1 (BR1)|BR1 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
769231|NCT00709852|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Average Reader (AR)|The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
769232|NCT00709852|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 3 (BR3)|BR3 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
769233|NCT00709852|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 2 (BR2)|BR2 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
769234|NCT00709852|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 1 (BR1)|BR1 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
769235|NCT00709852|Primary|Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Readers|The blinded readers evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another to determine the total number of lesions.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||lesions||Standard Deviation|Mean
769236|NCT00709852|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Average Reader (AR)|The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
769237|NCT00709852|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Blinded Reader 3 (BR3)|BR3 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
769238|NCT00709852|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Blinded Reader 2 (BR2)|BR2 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
769239|NCT00709852|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Blinded Reader 1 (BR1)|BR1 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|The full analysis set (FAS); which used data from all participants for whom data and images were available for the unenhanced MRI, combined unenhanced and gadobutrol-enhanced MRI, and combined unenhanced and gadoteridol-enhanced MRI, excluding the sample participants (the first participant from each study site).||scores on a scale||Standard Deviation|Mean
769240|NCT00709878|Primary|Differences in Histologic Alterations in Rash Caused by Lapatinib, a Dual HER1/2 Inhibitor (HER1/2i), and the Single HER1 Inhibitors (HER1i) Cetuximab, Erlotinib,and Panitumumab.||6 months|||Total number of cases|||Number
769241|NCT00709891|Secondary|Percentage of Participants With a Diagnosis of ≥ CIN3|A diagnosis of ≥ CIN3 (cervical intraepithelial neoplasia) included histology results of CIN3, adenocarcinoma in situ, squamous cell carcinoma, or adenocarcinoma. The diagnosis was based on central pathology review.|Baseline to the end of the study (up to 5 years, 1 month)|Evaluable ASC-US participant population: All enrolled participants with a diagnosis of atypical squamous cells of undetermined significance (ASC-US).||Percentage of participants|||Number
769242|NCT00709891|Primary|Percentage of Participants With a Diagnosis of ≥ CIN2|A diagnosis of ≥ CIN2 (cervical intraepithelial neoplasia) included histology results of CIN2, CIN3, adenocarcinoma in situ, squamous cell carcinoma, or adenocarcinoma. The diagnosis was based on central pathology review.|Baseline to the end of the Baseline period (up to 12 weeks)|Evaluable ASC-US participant population: All enrolled participants with a diagnosis of atypical squamous cells of undetermined significance (ASC-US).||Percentage of participants|||Number
769243|NCT00709956|Secondary|Borg Dyspnea Score|"The Borg scale is a category-ratio scale, commonly used to evaluate the effects of exercise on dyspnea. The original and modified scales have ratio properties ranging from 0 = nothing at all to 10 = very, very severe, with descriptors from 0 to 10. Descriptors have been modified by others so that 10 has been labeled extremely severe, or the worst possible dyspnea imaginable. Reliability and validity have been reported in a general population and in patients with PAH as well as other respiratory conditions."|Study day 2 or study day 3|The analysis was per protocol, 64 patients started double blind phase of study, 63 completed.||scores on a scale||Standard Deviation|Mean
769244|NCT00709956|Primary|6-minute-walk Distance (6MWD)|"The 6-minute walk test was performed 20-40 minutes after treatment. This was a non-encouraged test (the person conducting the test did not encourage the patient to walk farther or faster) that measured the distance covered over a 6-minute walk.
It was conducted by a trained member of the site staff who was listed on the site’s delegation of authority sheet. For patients who had never performed a 6-minute walk test previously, a training test was requested before the qualifying tests for randomization."|Study day 2 or study day 3|The analysis was per protocol, 64 patients started double blind phase of study, 63 completed.||meters||95% Confidence Interval|Least Squares Mean
769245|NCT00710021|Secondary|Percent of Participants With Adverse Events of Grade 3 or Above|Grades are based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0 over the duration of the study. Participants who experienced at least one grade 3 or higher adverse event (AE) are counted only once. The adverse events are treatment-emergent, which means that the AE occurred after taking the first dose of study drug.|From start of study treatment through Week 12|Safety||Percent of participants|||Number
769246|NCT00710021|Secondary|Renal BILAG Status at Week 12|The British Isles Lupus Assessment Group (BILAG) assessment gives a grade for each of 9 body systems (e.g., domains). Grades reflect systemic lupus erythematosus disease activity as follows: A (severe), B (moderate), C (mild), D (inactive at present but previously affected), E (inactive and system never involved). To be randomized, subjects had to have mild or inactive disease (C,D,E) in all but the mucocutaneous system in which B(moderate) disease was also allowed. The percent of subjects experiencing A or B level activity at Week 12 is assessed for the “Renal-specific” body system.|Week 12|Modified Intent-to-Treat with available data||Percent with grade A or B|||Number
769258|NCT00710021|Secondary|Change in Serum C4 Level From Baseline to Week 6|Outcome measure description: C4 is a blood test that measures the activity of the complement component 4 (C4) protein. The normal range for males is 12 to 72 mg/dL and the normal range for females is 13 to 75 mg/dL. Patients with active systemic lupus erythematosus may have a lower-than-normal level of C4. A decrease in C4 level over time may indicate disease activity. An increase in C4 from baseline to Week 6 is represented as a positive value (and vice versa).|0, Week 6|Modified Intent-to-Treat with available data||mg/dL||Standard Deviation|Mean
769247|NCT00710021|Secondary|Ophthalmic BILAG Status at Week 12|The British Isles Lupus Assessment Group (BILAG) assessment gives a grade for each of 9 body systems (e.g., domains). Grades reflect systemic lupus erythematosus disease activity as follows: A (severe), B (moderate), C (mild), D (inactive at present but previously affected), E (inactive and system never involved). To be randomized, subjects had to have mild or inactive disease (C,D,E) in all but the mucocutaneous system in which B(moderate) disease was also allowed. The percent of subjects experiencing A or B level activity at Week 12 is assessed for the “Ophthalmic-specific” body system.|Week 12|Modified Intent-to-Treat with available data||Percent with grade A or B|||Number
769248|NCT00710021|Secondary|Neuropsychiatric BILAG Status at Week 12|The British Isles Lupus Assessment Group (BILAG) assessment gives a grade for each of 9 body systems (e.g., domains). Grades reflect systemic lupus erythematosus disease activity as follows: A (severe), B (moderate), C (mild), D (inactive at present but previously affected), E (inactive and system never involved). To be randomized, subjects had to have mild or inactive disease (C,D,E) in all but the mucocutaneous system in which B(moderate) disease was also allowed. The percent of subjects experiencing A or B level activity at Week 12 is assessed for the “Neuropsychiatric-specific” body system.|Week 12|Modified Intent-to-Treat with available data||Percent with grade A or B|||Number
769249|NCT00710021|Secondary|Musculoskeletal BILAG Status at Week 12|Outcome measure description: The British Isles Lupus Assessment Group (BILAG) assessment gives a grade for each of 9 body systems (e.g., domains). Grades reflect systemic lupus erythematosus disease activity as follows: A (severe), B (moderate), C (mild), D (inactive at present but previously affected), E (inactive and system never involved). To be randomized, subjects had to have mild or inactive disease (C,D,E) in all but the mucocutaneous system in which B(moderate) disease was also allowed. The percent of subjects experiencing A or B level activity at Week 12 is assessed for the “Musculoskeletal-specific” body system.|Week 12|Modified Intent-to-Treat with available data||Percent with grade A or B|||Number
769250|NCT00710021|Secondary|Mucocutaneous BILAG Status at Week 12|The British Isles Lupus Assessment Group (BILAG) assessment gives a grade for each of 9 body systems (e.g., domains). Grades reflect systemic lupus erythematosus disease activity as follows: A (severe), B (moderate), C (mild), D (inactive at present but previously affected), E (inactive and system never involved). To be randomized, subjects had to have mild or inactive disease (C,D,E) in all but the mucocutaneous system in which B(moderate) disease was also allowed. The percent of subjects experiencing A or B level activity at Week 12 is assessed for the “Mucocutaneous-specific” body system.|Week 12|Modified Intent-to-Treat with available data||Percent with grade A or B|||Number
769251|NCT00710021|Secondary|Hematological BILAG Status at Week 12|The British Isles Lupus Assessment Group (BILAG) assessment gives a grade for each of 9 body systems (e.g., domains). Grades reflect systemic lupus erythematosus disease activity as follows: A (severe), B (moderate), C (mild), D (inactive at present but previously affected), E (inactive and system never involved). To be randomized, subjects had to have mild or inactive disease (C,D,E) in all but the mucocutaneous system in which B(moderate) disease was also allowed. The percent of subjects experiencing A or B level activity at Week 12 is assessed for the “Hematological-specific” body system.|Week 12|Modified Intent-to-Treat with available data||Percent with grade A or B|||Number
769252|NCT00710021|Secondary|Gastrointestinal BILAG Status at Week 12|The British Isles Lupus Assessment Group (BILAG) assessment gives a grade for each of 9 body systems (e.g., domains). Grades reflect systemic lupus erythematosus disease activity as follows: A (severe), B (moderate), C (mild), D (inactive at present but previously affected), E (inactive and system never involved). To be randomized, subjects had to have mild or inactive disease (C,D,E) in all but the mucocutaneous system in which B(moderate) disease was also allowed. The percent of subjects experiencing A or B level activity at Week 12 is assessed for the “Gastrointestinal-specific” body system.|Week 12|Modified Intent-to-Treat with available data||Percent with grade A or B|||Number
769253|NCT00710021|Secondary|Constitutional BILAG Status at Week 12|The British Isles Lupus Assessment Group (BILAG) assessment gives a grade for each of 9 body systems (e.g., domains). Grades reflect systemic lupus erythematosus disease activity as follows: A (severe), B (moderate), C (mild), D (inactive at present but previously affected), E (inactive and system never involved). To be randomized, subjects had to have mild or inactive disease (C,D,E) in all but the mucocutaneous system in which B(moderate) disease was also allowed. The percent of subjects experiencing A or B level activity at Week 12 is assessed for the “Constitutional-specific” body system.|Week 12|Modified Intent-to-Treat with available data||Percent with grade A or B|||Number
769254|NCT00710021|Secondary|Cardiorespiratory BILAG Status at Week 12|The British Isles Lupus Assessment Group (BILAG) assessment gives a grade for each of 9 body systems (e.g., domains). Grades reflect systemic lupus erythematosus disease activity as follows: A (severe), B (moderate), C (mild), D (inactive at present but previously affected), E (inactive and system never involved). To be randomized, subjects had to have mild or inactive disease (C,D,E) in all but the mucocutaneous system in which B(moderate) disease was also allowed. The percent of subjects experiencing A or B level activity at Week 12 is assessed for the “Cardiorespiratory-specific” body system.|Week 12|Modified Intent-to-Treat with available data||Percent with grade A or B|||Number
769255|NCT00710021|Secondary|Change in SELENA-SLEDAI Total Score From Baseline to Week 12|The modified Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus (SLE) Disease Activity Index (SELENA-SLEDAI) score is a weighted scale score ranging from 0 to 105 based on the presence or absence of 24 manifestations of SLE. The SELENA-SLEDAI assesses disease activity for 10 days prior to and including the day of assessment. For this study, the SELENA-SLEDAI score was modified to include proteinuria defined by dipstick rather than 24 hour urine. Positive change in the SELENA-SLEDAI score indicate increased disease activity.|0, Week 12|Modified Intent-to-Treat with available data||Change in Scores on a Scale||Standard Deviation|Mean
769256|NCT00710021|Secondary|Change in Status for Anti-double-stranded DNA Autoantibody From Baseline to Week 6|Patients with systemic lupus erythematosus (SLE) may have autoantibodies (e.g., self against self) to double-stranded DNA. Double-stranded DNA is one of multiple diagnostic tests for SLE and levels may be associated with disease activity. A positive test for autoantibodies to double-stranded DNA is based on the normal range from the local laboratory. Change in status (+ or -) from baseline is evaluated.|0, Week 6|Modified Intent-to-Treat with available data||Percent of participants|||Number
769366|NCT00710593|Secondary|Acquisition of HPV-16 DNA by Study Group and Study Visit (Week 48).|Type-specific HPV DNA among subjects who were both HPV DNA negative and HPV sero-negative by study group and study visit at Week 48.|Week 48|||percentage of participants|||Number
769259|NCT00710021|Secondary|Change in Serum C4 Level From Baseline to Week 12|C4 is a blood test that measures the activity of the complement component 4 (C4) protein. The normal range for males is 12 to 72 mg/dL and the normal range for females is 13 to 75 mg/dL. Patients with active systemic lupus erythematosus may have a lower-than-normal level of C4. A decrease in C4 level over time may indicate disease activity. An increase in C4 from baseline to Week 12 is represented as a positive value (and vice versa).|0, Week 12|Modified Intent-to-Treat with available data||mg/dL||Standard Deviation|Mean
769260|NCT00710021|Secondary|Change in Serum C3 Level From Baseline to Week 6|C3 is a blood test that measures the activity of the complement component 3 (C3) protein. The normal C3 range is 75 to 135 mg/dL. Patients with active systemic lupus erythematosus may have a lower-than-normal level of C3. A decrease in C3 level over time may indicate disease activity. An increase in C3 from baseline to Week 6 is represented as a positive value (and vice versa).|0, Week 6|Modified Intent-to-Treat with available data||mg/dL||Standard Deviation|Mean
769261|NCT00710021|Secondary|Change in Serum C3 Level From Baseline to Week 12|C3 is a blood test that measures the activity of the complement component 3 (C3) protein. The normal C3 range is 75 to 135 mg/dL. Patients with active systemic lupus erythematosus may have a lower-than-normal level of C3. A decrease in C3 level over time may indicate disease activity. An increase in C3 from baseline to Week 12 is represented as a positive value (and vice versa).|0, Week 12|Modified Intent-to-Treat with available data||mg/dL||Standard Deviation|Mean
769262|NCT00710021|Secondary|qRT-PCR Fold Change in Mx1 Gene Expression From Baseline to Week 6|The Mx1 gene is one of three genes included in the definition of the alpha-interferon signature used for this study. It encodes for the homolog of mouse myxovirus (influenza virus) resistance 1 protein. Quantitative real-time polymerase chain reaction (qRT-PCR) was used to measure gene expression in peripheral blood mononuclear cells obtained by blood draw. Gene expression is quantified as “fold change” relative to normal controls and is computed using a comparative CT (threshold cycle) method. A study hypothesis was that expression of alpha-interferon signature genes would decrease with increasing vitamin D levels. A decrease in gene expression from baseline to Week 6 is represented as a negative value (and vice versa).|0, Week 6|Modified Intent-to-Treat with available data||qRT-PCR fold change||Standard Deviation|Mean
769263|NCT00710021|Secondary|qRT-PCR Fold Change in Mx1 Gene Expression From Baseline to Week 12|The Mx1 gene is one of three genes included in the definition of the alpha-interferon signature used for this study. It encodes for the homolog of mouse myxovirus (influenza virus) resistance 1 protein. Quantitative real-time polymerase chain reaction (qRT-PCR) was used to measure gene expression in peripheral blood mononuclear cells obtained by blood draw. Gene expression is quantified as “fold change” relative to normal controls and is computed using a comparative CT (threshold cycle) method. A study hypothesis was that expression of alpha-interferon signature genes would decrease with increasing vitamin D levels. A decrease in gene expression from baseline to Week 12 is represented as a negative value (and vice versa).|0, Week 12|Modified Intent-to-Treat with available data||qRT-PCR fold change||Standard Deviation|Mean
769264|NCT00710021|Secondary|qRT-PCR Fold Change in Ifi44 Gene Expression From Baseline to Week 6|The Ifi44 gene is one of three genes included in the definition of the alpha-interferon signature used for this study. It encodes interferon-induced protein 44. Quantitative real-time polymerase chain reaction (qRT-PCR) was used to measure gene expression in peripheral blood mononuclear cells obtained by blood draw. Gene expression is quantified as “fold change” relative to normal controls and is computed using a comparative CT (threshold cycle) method. A study hypothesis was that expression of alpha-interferon signature genes would decrease with increasing vitamin D levels. A decrease in gene expression from baseline to Week 6 is represented as a negative value (and vice versa).|0, Week 6|Modified Intent-to-Treat with available data||qRT-PCR fold change||Standard Deviation|Mean
769265|NCT00710021|Secondary|qRT-PCR Fold Change in Ifi44 Gene Expression From Baseline to Week 12|The Ifi44 gene is one of three genes included in the definition of the alpha-interferon signature used for this study. It encodes interferon-induced protein 44. Quantitative real-time polymerase chain reaction (qRT-PCR) was used to measure gene expression in peripheral blood mononuclear cells obtained by blood draw. Gene expression is quantified as “fold change” relative to normal controls and is computed using a comparative CT (threshold cycle) method. A study hypothesis was that expression of alpha-interferon signature genes would decrease with increasing vitamin D levels. A decrease in gene expression from baseline to Week 12 is represented as a negative value (and vice versa).|0, Week 12|Modified Intent-to-Treat with available data||qRT-PCR fold change||Standard Deviation|Mean
769266|NCT00710021|Secondary|qRT-PCR Fold Change in Ifit1 Gene Expression From Baseline to Week 6|The Ifit1 gene is one of three genes included in the definition of the alpha-interferon signature used for this study. It encodes an interferon-induced protein with tetratricopeptide repeats. Quantitative real-time polymerase chain reaction (qRT-PCR) was used to measure gene expression in peripheral blood mononuclear cells obtained by blood draw. Gene expression is quantified as “fold change” relative to normal controls and is computed using a comparative CT (threshold cycle) method. A study hypothesis was that expression of alpha-interferon signature genes would decrease with increasing vitamin D levels. A decrease in gene expression from baseline to Week 6 is represented as a negative value (and vice versa).|0, Week 6|Modified Intent-to-Treat with available data||qRT-PCR fold change||Standard Deviation|Mean
769267|NCT00710021|Secondary|qRT-PCR Fold Change in Ifit1 Gene Expression From Baseline to Week 12|The Ifit1 gene is one of three genes included in the definition of the alpha-interferon signature used for this study. This gene encodes an interferon-induced protein with tetratricopeptide repeats. Quantitative real-time polymerase chain reaction (qRT-PCR) was used to measure gene expression in peripheral blood mononuclear cells obtained by blood draw. Gene expression is quantified as “fold change” relative to normal controls and is computed using a comparative CT (threshold cycle) method. A study hypothesis was that expression of alpha-interferon signature genes would decrease with increasing vitamin D levels. A decrease in gene expression from baseline to Week 12 is represented as a negative value (and vice versa).|0, Week 12|Modified Intent-to-Treat with available data||qRT-PCR fold change||Standard Deviation|Mean
769282|NCT00710424|Secondary|Change From Baseline in the Use of Rescue Analgesia at the End of Treatment|The mean daily number of paracetamol tablets used were calculated for the periods over which the primary endpoint was calculated.|Day 0 - Day 98|The primary population for analysis was the full analysis set, which included all randomised subjects who received at least one dose of study medication and yielded on-treatment efficacy data.||Tablets||Standard Deviation|Mean
769268|NCT00710021|Secondary|Percent of Participants With IFN Alpha Signature at Week 6|An Interferon (IFN) Alpha signature is defined as: expression of Mx1, Ifit1, or Ifi44 at a level greater than or equal to 4 standard deviations above the mean of a set of normal controls, or expression of 2 of the 3 genes at a level greater than or equal to 2 standard deviations above the mean of a set of normal controls. Gene expression was measured on peripheral blood samples using qRT-PCR. Missing data were assumed as signatures during calculation.|Week 6|Modified Intent-to-Treat. Although presence of a positive IFN Alpha Signature at the Screening visit was an entry criterion for the study, 8 subjects (4 Placebo, 2 Vitamin D3 2000 IU, 2 Vitamin D3 4000 IU) who did not have a signature were included in the study.||Percent of participants|||Number
769269|NCT00710021|Secondary|Percent of Participants With IFN Alpha Signature at Week 12|An Interferon (IFN) Alpha signature is defined as: expression of Mx1, Ifit1, or Ifi44 at a level greater than or equal to 4 standard deviations above the mean of a set of normal controls, or expression of 2 of the 3 genes at a level greater than or equal to 2 standard deviations above the mean of a set of normal controls. Gene expression was measured on peripheral blood samples using qRT-PCR. Missing data were assumed as signatures during calculation.|0, Week 12|Modified Intent-to-Treat. Although presence of a positive IFN Alpha Signature at the Screening visit was an entry criterion for the study, 8 subjects (4 Placebo, 2 Vitamin D3 2000 IU, 2 Vitamin D3 4000 IU) who did not have a signature were included in the study.||Percent of participants|||Number
769270|NCT00710021|Secondary|Percent of Participants With an IFN Alpha Signature Response at Week 6|Presence of an Interferon (IFN) Alpha signature response is defined as: a reduction in expression from baseline (Screening) of at least 50% for 1 of 3 IFN Alpha responsive genes (Ifit1, Ifi44, Mx1) with concurrent expression in the remaining 2 genes at a level not more than 25% above baseline, or a reduction in expression from baseline of at least 25% for 2 of the 3 IFN Alpha responsive genes with concurrent expression in the third gene at a level of no more than 25% above baseline. Gene expression was measured on peripheral blood samples using qRT-PCR. Missing data were considered as response failures during calculation.|0, Week 6|Modified Intent-to-Treat. Although presence of a positive IFN Alpha Signature at the Screening visit was an entry criterion for the study, 8 subjects (4 Placebo, 2 Vitamin D3 2000 IU, 2 Vitamin D3 4000 IU ) who did not have a signature were included in the study.||Percent of participants|||Number
769271|NCT00710021|Primary|Percent of Participants With an IFN Alpha Signature Response at Week 12|Presence of an Interferon (IFN) Alpha signature response is defined as: a reduction in expression from baseline (Screening) of at least 50% for 1 of 3 IFN Alpha responsive genes (Ifit1, Ifi44, Mx1) with concurrent expression in the remaining 2 genes at a level not more than 25% above baseline, or a reduction in expression from baseline of at least 25% for 2 of the 3 IFN Alpha responsive genes with concurrent expression in the third gene at a level of no more than 25% above baseline. Gene expression was measured on peripheral blood samples using qRT-PCR. Missing data were considered as response failures during calculation.|0, Week 12|Modified Intent-to-Treat. Although presence of a positive IFN Alpha Signature at the Screening visit was an entry criterion for the study, 8 subjects (4 Placebo, 2 Vitamin D3 2000 IU, 2 Vitamin D3 4000 IU ) who did not have a signature were included in the study.||Percent of participants|||Number
769272|NCT00710203|Other Pre-specified|Evidence of Texture Irregularities|The physician assessed evidence of texture irregularities.|6 to 12 weeks|||lesions|||Number
769273|NCT00710203|Other Pre-specified|Evidence of Scar|The physician assessed evidence of scar.|6 to 12 weeks|||lesions|||Number
769274|NCT00710203|Other Pre-specified|Evidence of Hyperpigmentation|The physician assessed evidence of hyperpigmentation.|6 to 12 weeks|||lesions|||Number
769275|NCT00710203|Other Pre-specified|Evidence of Hypopigmentation|The physician assessed evidence of hypopigmentation.|6 to 12 weeks|||lesions|||Number
769276|NCT00710203|Primary|Percent Clearance of All Lesions|The physician assessed percent clearance of all treated lesions and the control lesion.|6 to 12 weeks|||percentage of lesion clearance|Participants|Standard Deviation|Mean
769277|NCT00710385|Secondary|"Drug Liking"|"Participant's subjective ratings of how much they Like the dose they just received on a scale of 0 -100."|Peak (highest) rating obtained following drug administration throughout the entire 3 hr session|||units on a scale||Standard Error|Mean
769278|NCT00710385|Primary|Drug's Breakpoint|"Measure of a drug's reinforcing effects. The Breakpoint is the point at which the participant stop performing an operant task (clicks on a mouse) in order to received the drug. Therefore, the reported breakpoint is the total amount of work the participant was willing to perform to receive the dose being tested"|Single measurement taken following each of the 7 IV experimental doses|Heroin users, not seeking treatment||number of clicks on a mouse||Standard Deviation|Mean
769279|NCT00710424|Primary|Number of Responders at the 30% Improvement Level at the End of Treatment|"A positive 30% pain response is defined as a reduction of at least 30% in the mean NRS average pain score from baseline to week 14 (last 7 days). The patient was asked on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain. The average pain NRS was completed at the same time each day, i.e. bedtime in the evening. Estimates were produced for a one-week period, with the evaluable period finishing at the end of the appropriate seven-day period."|Day 0 - Day 98|All subjects who were randomised and received at least one actuation of study medication were included in the analysis. Subjects with no data during the primary period (i.e. unknown response) were included in the analysis, and were classed as non-responders.||participants|||Number
769280|NCT00710424|Secondary|Change From Baseline in Mean Intoxication 0-10 Numerical Rating Scale Score at the End of Treatment|Subjects rated their intoxication levels on a scale of 0-10, where 0 equals “no intoxication” and 10 equals “extreme intoxication”. A negaitve value from baseline indicates and improvement. End of treatment was classed as the last on-treatment visit where data was recorded.|Day 0 - Day 98|The primary population for analysis was the full analysis set, which included all randomised subjects who received at least one dose of study medication and yielded on-treatment efficacy data.||units on a scale||Standard Deviation|Mean
769281|NCT00710424|Secondary|Incidence of Adverse Events as a Measure of Subject Safety|The number of subjects who experienced an adverse event during the course of the study (including the follow-up period i.e 28 days after the end of treatment) is presented.|Day 0 - Day 133|The primary population for analysis was the full analysis set, which included all randomised subjects who received at least one dose of study medication and yielded on-treatment efficacy data.||participants|||Number
769283|NCT00710424|Secondary|Change From Baseline in Mean Quality of Life EuroQol 5-D Weighted Health State Index Score at the End of Treatment Measured by Visual Analogue Scale|The EuroQol-5D Health Status Visual Analogue Scale rated the health state on a scale of 0-100 with 0 = worst health state imaginable to 100 = best health state imaginable. An increase in score indicates an improvement in condition.|Day 0 and Day 98|The primary population for analysis was the full analysis set, which included all randomised subjects who received at least one dose of study medication and yielded on-treatment efficacy data.||units on a scale||Standard Deviation|Mean
769284|NCT00710424|Secondary|Change From Baseline in Mean Brief Pain Inventory (Short Form)'Pain Severity Composite Score' at the End of Treatment|The brief pain inventory (short form) is a 14-item questionnaire that asks patients to rate pain over the prior week and the degree to which it interferes with activities on a 0 to 10 scale, where 0=no pain and 10=pain as bad as you can imagine. Severity is measured as worst pain, least pain, average pain, and pain right now. The pain severity composite score was calculated as the arithmetic mean of the four severity items (range 0-10). The minimum value is zero and maximum is 10. A higher score represents a poor outcome.|Day 0 and Day 98|The primary population for analysis was the full analysis set, which included all randomised subjects who received at least one dose of study medication and yielded on-treatment efficacy data.||units on a scale||Standard Deviation|Mean
769285|NCT00710424|Secondary|Subject Global Impression of Change at the End of Treatment|The subject was to assess the change in their nerve pain due to diabetic neuropathy at the end of the study compared to baseline on a 7-point scale from very much worse to very much improved. The number of participants reporting each score is presented.|Day 0 and Day 98|The primary population for analysis was the full analysis set, which included all randomised subjects who received at least one dose of study medication and yielded on-treatment efficacy data.||participants|||Number
769286|NCT00710424|Secondary|Change From Baseline in Mean Sleep Quality 0-10 Numerical Rating Scale Score at the End of Treatment|"The sleep quality Numerical Rating Scale was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate the number that best describes your sleep quality in the last 24 hours where 0 = slept extremely well and 10 = unable to sleep at all. A negative value indicates an improvement in pain score from baseline. The analyses were based on the change from baseline for the last assessment falling within the evaluable period (considered the end of treatment)."|Day 0 - Day 98|The primary population for analysis was the full analysis set, which included all randomised subjects who received at least one dose of study medication and yielded on-treatment efficacy data.||units on a scale||Standard Deviation|Mean
769287|NCT00710424|Secondary|Change From Baseline in Mean Neuropathic Pain Scale Score at the End of Treatment|The Neuropathic Pain Scale score is the 0-100 sum of 10 individual pain scores (0-10 Numerical Rating Scale, 0= no pain to 10 = most pain imaginable). A negative change from baseline indicates an improvement in pain. The baseline mean Neuropathic Pain Scale score was to be the mean of the two assessments during the baseline period, with the end of study value as the mean of the last two assessments made during the evaluable period.|Day 0 to Day 98|The primary population for analysis was the full analysis set, which included all randomised subjects who received at least one dose of study medication and yielded on-treatment efficacy data.||units on a scale||Standard Deviation|Mean
769288|NCT00710424|Primary|The Change From Baseline in Mean Diabetic Neuropathy Pain 0-10 Numerical Rating Scale Score at the End of Treatment (Average of Last 7 Days Treatment)|"The diabetic neuropathy pain Numerical Rating Scale was complete at the end of every day. The patient was asked on a scale of '0 to 10', please indicate the number that best describes your nerve pain due to diabetes in the last 24 hours where 0 = no pain and 10 = worst possible pain. No pain relates to the time prior to the onset of pain due to diabetic neuropathy. For those whose evaluable period ended before Day 7, the mean of the available post-randomisation data was used. Those with no post-baseline diary pain 0-10 Numerical Rating Scale scores were excluded from the analysis."|Day 0 to Day 98|The primary population for analysis was the full analysis set, which included all randomised subjects who received at least one dose of study medication and yielded on-treatment efficacy data.||units on a scale||Standard Deviation|Mean
769289|NCT00702650|Secondary|Change From Baseline to Endpoint in Draize Score|Draize score is a measurement of skin irritability of the application site based on erythema/eschar and oedema. Erythema/eschar scoring ranges from 0 (no erythema) to 4 (severe erythema [beet redness] to slight eschar formation [injuries in depth]). Oedema scoring ranges from 0 (no oedema) to 4 (severe oedema [raised more than 1 millimeter and extending beyond area of exposure]. The total Draize score ranges from 0 to 8.|Baseline, Day 120|Participants enrolled in the study who had a baseline and a measurement at endpoint: Day 120.||units on a scale||Standard Deviation|Mean
769290|NCT00702650|Secondary|Change From Baseline to Endpoint in Haematocrit|Haematocrit: percentage of total blood volume made up of blood cells|Baseline, up to Day 120|Participants enrolled in the study who had a baseline and a measurement at endpoint: Day 120, follow-up, or early withdrawal.||percentage of red blood cells||Standard Deviation|Mean
769291|NCT00702650|Secondary|Change From Baseline to Endpoint in Haemoglobin||Baseline, up to Day 120|Participants enrolled in the study who had a baseline and a measurement at endpoint: Day 120, follow-up, or early withdrawal.||g/dL||Standard Deviation|Mean
769292|NCT00702650|Secondary|Change From Baseline to Endpoint in Estradiol||Baseline, up to Day 120|Participants enrolled in the study who had a baseline and a measurement at endpoint: Day 120, follow-up, or early withdrawal.||pg/mL||Standard Deviation|Mean
769293|NCT00702650|Secondary|Change From Baseline to Endpoint in Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH)||Baseline, up to Day 120|Participants enrolled in the study who had a baseline and a measurement at endpoint: Day 120, follow-up, or early withdrawal.||mIU/mL||Standard Deviation|Mean
769294|NCT00702650|Secondary|Change From Baseline to Endpoint in Prostate Specific Antigen (PSA)||Baseline, Day 120|Participants enrolled in the study who had a baseline and a measurement at endpoint: Day 120.||ng/mL||Standard Deviation|Mean
769295|NCT00702650|Secondary|Change From Baseline to Endpoint in Fasting Glucose||Baseline, up to Day 120|Participants enrolled in the study who had a baseline and a measurement at endpoint: Day 120, follow-up, or early withdrawal.||mg/dL||Standard Deviation|Mean
769296|NCT00702650|Secondary|Change From Baseline to Endpoint in Fasting Insulin||Baseline, up to Day 120|Participants enrolled in the study who had a baseline and a measurement at endpoint: Day 120, follow-up, or early withdrawal.||uIU/mL||Standard Deviation|Mean
769297|NCT00702650|Secondary|Change From Baseline to Endpoint in the 36-Item Short-Form Health Survey (SF-36)|The SF-36 Health Status Survey is a generic, health-related scale assessing subjects’ quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). MCS and PCS scores=0-100 (higher scores indicate better health status).|Baseline, Day 120|All participants who received at least one dose of study drug, had baseline and on-treatment data for at least one efficacy variable, and completed the Day 120 visit.||units on a scale||Standard Deviation|Mean
769298|NCT00702650|Secondary|Change From Baseline to Endpoint in Psychosexual Daily Questionnaire|Questions included: Sexual Desire (0=none to 7=very high), Overall Sexual Activity Score (calculated as average of weekly values on scale from 0=none to 7=Frequent), Erection Maintained for Satisfactory Duration (0=not satisfactory to 7=very satisfactory), and Positive and Negative Mood (individual mood variables on scale from 0=Not at all true to 7=very true). Positive mood: sum of 4 positive mood variables-alert, full of pep/energetic, friendly, and well/good (range from 0-28). Negative mood: sum of 5 negative mood variables-angry, irritable, sad/blue, tired, and nervous (range from 0-35).|Baseline, Day 120|All participants who received at least one dose of study drug, had baseline and on-treatment data for at least one efficacy variable, and completed the Day 120 visit.||units on a scale||Standard Deviation|Mean
769299|NCT00702650|Secondary|Percentage of Participants With Minimum Concentration (Cmin) <300 ng/dL|Cmin is the minimum observed serum concentration (<300 ng/dL) during the 24 hour period on Day 120.|Day 120|All participants who received at least one dose of study drug, had on-treatment data for at least one efficacy variable, and completed the Day 120 visit.||percentage of participants|||Number
769300|NCT00702650|Secondary|Percentage of Participants With Cmax >2500 ng/dL|Cmax is the maximum observed serum concentration (>2500 ng/dL) during the 24 hour period on Day 120.|Day 120|All participants who received at least one dose of study drug, had on-treatment data for at least one efficacy variable, and completed the Day 120 visit.||percentage of participants|||Number
769301|NCT00702650|Secondary|Percentage of Participants With Cmax Between 1800 and 2500 ng/dL|Cmax is the maximum observed serum concentration (between 1800 and 2500 ng/dL) during the 24 hour period on Day 120.|Day 120|All participants who received at least one dose of study drug, had on-treatment data for at least one efficacy variable, and completed the Day 120 visit.||percentage of participants|||Number
769302|NCT00702650|Secondary|Percentage of Participants With Maximum Serum Concentration (Cmax) >1500 ng/dL|Cmax is the maximum observed serum concentration (>1500 ng/dL) during the 24 hour period on Day 120.|Day 120|All participants who received at least one dose of study drug, had on-treatment data for at least one efficacy variable, and completed the Day 120 visit.||percentage of participants|||Number
769303|NCT00702650|Primary|Percentage of Participants With 24-Hour Average Concentration [Cavg(0-24h)] Total Testosterone Within Normal Range at Day 120|Cavg(0-24) is the average serum concentration calculated over the 24 hour period on Day 120. Calculated as the AUC(0-24) divided by 24 hours. Normal range for Total Testosterone was defined as 300 - 1050 nanograms per deciliter (ng/dL).|Day 120|All participants who received at least one dose of study drug, had on-treatment data for at least one efficacy variable, and completed the Day 120 visit. Participants were also included if they withdrew prior to Day 120 because of adverse event or lack of efficacy (considered as treatment failures).||percentage of participants||95% Confidence Interval|Number
769304|NCT00702689|Secondary|Change in Immunosuppression|Change in immunosuppression was defined by an increase or decrease in steroid use form baseline.|6 months|Pred:prednisone; tacro:tacrolimus; MPred:methylprednisolone; siro:sirolimus; and MMF:mycophenolate mofetil||participants|||Number
769305|NCT00702689|Secondary|Lung Function Score at Baseline and 6 Months|Lung function was graded by the National Institutes of Health Chronic Graft Versus Host Disease organ response criteria. The Lung function score = forced expiratory volume 1 (FEV1) score + carbon monoxide diffusing capacity (DLCO) score, with a possible range of 2 (better outcome)-12 (worst outcome). The percent predicted FEV1 and DLCO (adjusted for hematocrit but not alveolar volume) should be converted to a numeric score as follows: >80% =1; 70-79% = 2; 60-69% = 3; 50-59% = 4; 40-49% = 5; <40% = 6.|Baseline and 6 Months|||units on a scale|||Number
769306|NCT00702689|Secondary|Total Chronic Graft Versus Host Disease (cGVHD) Provider Global Rating Score at Baseline and 6 Months|The provider global rating is a physician impression of severity of cGVHD symptoms from a scale of zero (no symptoms) to 10 (most severe GVHD symptoms possible).|Baseline and 6 months|||Provider Global Rating Score|||Number
769307|NCT00702689|Secondary|Total Skin Score at Baseline and 6 Months|Total skin score was graded by the National Institutes of Health Consensus Criteria. Skin score was calculated by dividing the total score by seven domains (skin, eye, oral, joint, gastrointestinal, hepatic, pulmonary) in men and 8 domains in women (previous domains noted plus gynecologic). Total skin score is a percentage of body surface area (BSA) involvement (range 0-100%). It was calculated from the sum of moveable body surface BSA and non-moveable BSA. Higher numbers = greater body surface area affected.|Baseline and 6 Months|||units on a scale|||Number
769308|NCT00702689|Secondary|Average Percentage Change in Range of Motion (ROM) Deficit|One or more joints were assessed for ROM deficit by a physiatrist with expertise in graft versus host disease and joint ROM.|6 months|This outcome is the average percentage change in ROM deficit among 13 evaluable patients based on each patients baseline range of motion deficit compared to his/her ROM deficit at 6 months.||Percent change||Inter-Quartile Range|Mean
769309|NCT00702689|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|41 months, 27 days|||Participants|||Number
769310|NCT00702689|Primary|Primary Range of Motion (ROM) Response|Progressive disease is defined as joint ROM: decrease of >25% in composite ROM score on 2 consecutive evaluations at least 2 weeks apart, but not greater than 4 weeks apart or steroid pulse: >1 steroid pulse per 3 month period if administered for sclerotic-type chronic graft versus host disease (ScGVHD). Response is joint ROM: increase of >25% in composite ROM score. Maximal response is a response with no further improvement over 2 sequential 3-month evaluations. Stable disease does not meet the criteria for progression, response, or maximal response.|6 months|||participants|||Number
769367|NCT00710593|Secondary|Acquisition of HPV-11 DNA by Study Group and Study Visit (Week 48).|Type-specific HPV DNA among subjects who were both HPV DNA negative and HPV sero-negative by study group and study visit at Week 48.|Week 48|||percentage of participants|||Number
769311|NCT00702689|Primary|Percent Change in Absolute Range of Motion (ROM) From Baseline to 6 Months|A change in ROM is 25% or greater from baseline. A partial response required improvement in 25% or more in ROM. Progression required 25% or greater loss of ROM.Patients with negative values in the Table are those who lost ROM. Percent improvement in ROM for 1-3 target joints. For patients with >1 target joint, the average ROM improvement was calculated. The average percentage change in ROM deficit from baseline to 6 months was obtained based on the number of degrees of ROM change (6 months)/total ROM deficit (baseline) at each joint.|6 months|||Percent change from baseline|||Number
769312|NCT00702702|Primary|Change in Hemoglobin vs Placebo|Comparison between 50 mg Proellex and placebo of change in hemoglobin at month 3|3 months|Study prematurely terminated for safety reasons|||||
769313|NCT00702715|Secondary|Time to Recovery of T4/T1 Ratio to 0.7|Neuromuscular functioning was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.9. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade, with a value of 1.0 representing full recovery.|start of administration of sugammadex to recovery from neuromuscular blockade|Analysis performed using the Intent-to-Treat (ITT) Population, which consisted of all treated subjects who had at least one efficacy measurement.||seconds||95% Confidence Interval|Geometric Mean
769314|NCT00702715|Secondary|Time to Recovery of the T4/T1 Ratio to 0.8|Neuromuscular functioning was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.9. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade, with a value of 1.0 representing full recovery.|start of administration of sugammadex to recovery from neuromuscular blockade|Analysis performed using the Intent-to-Treat (ITT) Population, which consisted of all treated subjects who had at least one efficacy measurement.||seconds||95% Confidence Interval|Geometric Mean
769315|NCT00702715|Primary|Time to Recovery of the T4/T1 Ratio to 0.9.|Neuromuscular functioning was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.9. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade, with a value of 1.0 representing full recovery.|start of administration of sugammadex to recovery from neuromuscular blockade|Analysis performed using the Intent-to-Treat (ITT) Population, which consisted of all treated subjects who had at least one efficacy measurement.||seconds||95% Confidence Interval|Geometric Mean
769316|NCT00702754|Secondary|Treatment Assessment Scale (TAS), Approx Wk 84 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms|7 point scale (-3=significantly worse, 0=no change, +3=significantly better). Comparison Wk 84 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms|Session 8 (84 Wks) - 4 weeks post-injection compared to baseline|Safety Population/Intent to Treat||points on a scale||Standard Deviation|Mean
769317|NCT00702754|Secondary|Treatment Assessment Scale (TAS), Approx Wk 72 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms|7 point scale (-3=significantly worse, 0=no change, +3=significantly better). Comparison Wk 72 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms|Session 7 (72 Wks) - 4 weeks post-injection compared to baseline|Safety Population/Intent to Treat||points on a scale||Standard Deviation|Mean
769318|NCT00702754|Secondary|Treatment Assessment Scale (TAS), Approx Wk 60 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms|7 point scale (-3=significantly worse, 0=no change, +3=significantly better). comparison Wk 60 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms|Session 6 (60 Wks) - 4 weeks post-injection compared to baseline|Safety Population/Intent to Treat||points on a scale||Standard Deviation|Mean
769319|NCT00702754|Secondary|Treatment Assessment Scale (TAS), Approx Wk 48 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms|7 point scale (-3=significantly worse, 0=no change, +3=significantly better). Comparison of Wk 48 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms|Session 5 (48 Wks) - 4 weeks post-injection compared to baseline|Safety Population/Intent to Treat||points on a scale||Standard Deviation|Mean
769320|NCT00702754|Secondary|Treatment Assessment Scale (TAS), Approx Wk 36 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms|7 point scale (-3=significantly worse, 0=no change, +3=significantly better). Comparison of Wk 36 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms|Session 4 (36 Wks) - 4 weeks post-injection compared to baseline|safety population/Intent to Treat||points on a scale||Standard Deviation|Mean
769321|NCT00702754|Secondary|Treatment Assessment Scale (TAS), Approx Wk 24 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms|7 point scale (-3=significantly worse, 0=no change, +3=significantly better). Comparison of Wk 24 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms|Session 3 (24 Wks) - 4 weeks post-injection compared to baseline|safety population/Intent to Treat||points on a scale||Standard Deviation|Mean
769322|NCT00702754|Secondary|Treatment Assessment Scale (TAS), Approx Wk 12 + 4 Wks Post-Injection Compared to Baseline. Rating of Cervical Dystonia Symptoms|7 point rating scale (-3=significantly worse, 0=no change, +3=significantly better), comparison of Wk 12 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms|Session 2 (12 wks) - 4 weeks post-injection compared to baseline|safety population/Intent to Treat||points on a scale||Standard Deviation|Mean
769323|NCT00702754|Primary|Treatment Assessment Scale (TAS), 4 Wks Post-injection Compared to Baseline (Time 0), Rating of Cervical Dystonia Symptoms|7 point rating scale (-3 = significantly worse, 0 = no change, +3 = significantly better. Comparison at Wk 4 to baseline. Rating of Cervical Dystonia Symptoms|Session 1 - Time 0, 4 weeks post-injection compared to baseline|Safety Population/Intent to Treat||points on a scale||Standard Error|Mean
769324|NCT00702780|Primary|% Change of Whole Brain Volume||52 weeks|The analysis was performed for per-protocol (PP) population, which included participants who had both baseline and follow-up MRI scan suitable for analysis.||percentage of change||Standard Deviation|Mean
769325|NCT00702780|Primary|% Change of Hippocampus Volume||52 weeks|The analysis was performed for per-protocol (PP) population, which included participants who had both baseline and follow-up MRI scan suitable for analysis.||percentage of change||Standard Deviation|Mean
769326|NCT00702845|Secondary|Number of Participants With Pregnancies|A Biochemical Pregnancy was defined as a pregnancy proven by a biochemical pregnancy test. (Participants not having a positive biochemical pregnancy test result, but with an ultrasound showing at least one gestational sac were counted as having a biochemical pregnancy.) A Clinical Pregnancy was defined as the presence of at least one gestational sac as assessed by an USS scan. A Vital Pregnancy was considered the presence of at least one fetus with heart activity as assessed by USS. An Ongoing Pregnancy was defined as the presence of at least one fetus with heart activity at least 10 weeks after ET as assessed by USS or Doppler, or confirmed by live birth.|Up to 10 weeks after ET (up to a maximum of 14 weeks)|ITT Group, which consisted of all randomized participants who received corifollitropin alfa or recFSH.||Participants|||Number
769327|NCT00702845|Secondary|Number of Participants With Miscarriages|"A miscarriage, also known as a spontaneous abortion, was defined as the loss of a fetus without induction or instrumentation."|Up to 10 weeks after ET (up to a maximum of 14 weeks)|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who had a biological pregnancy.||Participants|||Number
769328|NCT00702845|Secondary|Implantation Rate for Participants With ET|The implantation rate was defined as 100 times the maximum number of gestational sacs as assessed by any ultrasound scan (USS) after ET divided by the number of embryos transferred (per participant), maximized to 100%.|Up to 6 weeks after ET within a treatment cycle (up to a maximum 10 weeks)|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who underwent ET.||Percentage||Standard Deviation|Mean
769329|NCT00702845|Secondary|Number and Quality of Embryos Obtained at Day 3 (Restricted to Participants With IVF and/or ICSI)|"Embryo quality was rated Grade 1, 2, 3, or other. Grade 1 represented excellent quality; Grade 2 good quality; Grade 3 fair quality. Other grade embryos were those that did not qualify as Grade 1, 2, or 3."|Post fertilization Day 3 (up to a maximum of 2 days after hCG administration)|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who underwent IVF and/or ICSI.||Number of embryos||Standard Deviation|Mean
769330|NCT00702845|Secondary|Fertilization Rate|Fertilization rate, defined as 100 times the ratio of the number of fertilized 2 pronuclei (PN) oocytes obtained and the number of oocytes incubated, was tabulated for each treatment group.|Up to 10 weeks after ET|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received fertilized oocytes.||Percentage||Standard Deviation|Mean
769331|NCT00702845|Secondary|Number and Quality of Oocytes Assessed Prior to ICSI (Restricted to Participants With ICSI Only)|The number of oocytes used for ICSI was assessed and categorized based on their quality (i.e., metaphase I oocytes, metaphase II oocytes, and germinal vesicles stage oocytes).|Up to 36 hours after administration of hCG|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who underwent ICSI.||Number of oocytes||Standard Deviation|Mean
769332|NCT00702845|Secondary|Number and Size Distribution of Follicles During Stimulation and on the Day of hCG Administration|For each participant, the number of follicles ≥11 mm, ≥15 mm, and ≥17 mm, documented by ultrasonography on defined days during the treatment cycle, was calculated.|Predose up to day of hCG administration (up to a maximum total duration of 19 stimulation days, including day of hCG administration)|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG.||Follicles||Standard Deviation|Mean
769333|NCT00702845|Secondary|Serum Inhibin-B Levels (Restricted to Participants With hCG Injection)|Blood samples for assessment of serum inhibin-B were taken prior to injection on Stimulation Day 1, Day 3, Day 5, Day 8, Day of hCG, Day of ET, at the visit two weeks after ET.|Predose up to 2 weeks after ET (up to maximum of 6 weeks)|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG.||pg/mL||Full Range|Median
769334|NCT00702845|Secondary|Serum Progesterone (P) Levels (Restricted to Participants With hCG Injection)|Blood samples for assessment of serum P were taken prior to injection on Stimulation Day 1, Day 3, Day 5, Day 8, Day of hCG, Day of ET, at the visit two weeks after ET.|Predose up to 2 weeks after ET (up to maximum of 6 weeks)|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG.||nmol/L||Full Range|Median
769335|NCT00702845|Secondary|Serum Estradiol (E2) Levels (Restricted to Participants With hCG Injection)|Blood samples for assessment of serum E2 were taken prior to injection on Stimulation Day 1, Day 3, Day 5, Day 8, Day of hCG, Day of ET, at the visit two weeks after ET.|Predose up to 2 weeks after ET (up to maximum of 6 weeks)|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG.||pmol/L||Full Range|Median
769336|NCT00702845|Secondary|Serum Lutenizing Hormone (LH) Levels (Restricted to Participants With hCG Injection)|Blood samples for assessment of serum LH were taken prior to injection on Stimulation Day 1, Day 3, Day 5, Day 8, Day of hCG, Day of ET, at the visit two weeks after ET.|Predose up to 2 weeks after ET (up to maximum of 6 weeks)|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG.||IU/L||Full Range|Median
769337|NCT00702845|Secondary|Serum Follicle Stimulating Hormone (FSH) Levels (Restricted to Participants With hCG Injection)|Blood samples for assessment of serum FSH were taken prior to injection on Stimulation Day 1, Day 3, Day 5, Day 8, Day of hCG, Day of ET, at the visit two weeks after ET.|Predose up to 2 weeks after ET (up to maximum of 6 weeks)|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG.||IU/L||Full Range|Median
769338|NCT00702845|Secondary|Total Duration of Stimulation (Days)|Total duration of stimulation was defined as the number of days from first drug administration up to and including the Day of hCG administration.|One COS cycle (up to a maximum total duration of 19 stimulation days)|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG.||Days||Full Range|Median
769339|NCT00702845|Secondary|Number of Days Treated With recFSH|Numbers of days treated with recFSH was defined as the total number of days participants received recFSH (excluding coasting days) until they reached the criterion for administration of hCG (at least 3 follicles >=17mm).|One COS cycle (up to a maximum total duration of 19 stimulation days)|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG.||Days||Full Range|Median
769342|NCT00702845|Primary|Number of Cumulus-oocyte-complexes Retrieved, Per Attempt|The primary efficacy parameter was defined as the number of cumulus-oocyte-complexes retrieved from participants in a controlled ovarian stimulation (COS) cycle for in vitro fertilization (IVF) and/or intracytoplasmic sperm injection (ICSI). For participants who did not have cumulus-oocyte-complex retrieval, the number retrieved was set to zero.|One COS cycle with cumulus-oocyte-complex retrieval (up to a maximum total duration of 21 days)|Intent-to-Treat (ITT) Group, which consisted of all randomized participants who received corifollitropin alfa or recFSH.||Number of cumulus-oocyte-complexes||Standard Deviation|Mean
769343|NCT00702884|Secondary|Quantitative Assessment of Proliferating Tumor Cells and Apoptosis|Biopsy sample taken from patients before and after treatment Apoptosis measures using the terminal deoxynucleotidyl transferase-mediated dUTP nick end labeling (TUNEL) assay, which measures 3’ nicked DNA. DNA is degraded in the early steps of apoptosis into low molecular weight (LMW) fragments and the production of single strand breaks in the high molecular weight DNA.Both of these features of apoptosis can be detected by labeling free 3’-OH termini with modified nucleotides, in our case this will be biotin-labeled dUTP. Terminal deoxynucleotidyl transferase (TdT) is an enzyme that labels blunt-ends of DNA breaks and can catalyze polymerization of nucleotides to free 3’-OH DNA ends in a template-independent manner. The newly incorporated nucleotides are detected by a secondary antibody, avidin-peroxidase. After substrate reaction, the stained cells can be detected and counted under a light microscope. Apoptotic cells will be fixed with formaldehyde which links LMW DNA|up to 4 years|Analysis for tumor cells not performed due to insufficient samples available|||||
769344|NCT00702884|Secondary|Change in Mean Vessel Density|Quantitative assessment of proliferating tumor cells, and apoptosis, of the laboratory and radiographic correlates, the analyses will be purely explorative.|up to 4 years|Insufficient tissue was available and the analysis for mean vessel density not performed|||||
769345|NCT00702884|Secondary|Frequency and Severity of Adverse Events|The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting.|up to 4 years|||percentage of patients|||Number
769346|NCT00702884|Secondary|Median Progression-free Survival Time|Progression free survival was measured as the time from start of treatment to the first measurement of tumor growth.|up to 4 years|||weeks||95% Confidence Interval|Median
769347|NCT00702884|Secondary|Median Overall Survival Time|The median overall survival time will be reported using the 95% confidence intervals for the parameters.|up to 4 years|||weeks||95% Confidence Interval|Median
769348|NCT00702884|Secondary|Overall Response Rate|The Overall Response Rate (ORR) was assessed using Partial Response + Complete Response for patients. Response and progression was evaluated in this study using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0.|up to 4 years|Durable Complete Response= PR + SD > 10 weeks||patients|||Number
769349|NCT00702884|Primary|Progression-free Survival Rate|Complete response, partial response, and stable disease) as assessed by RECIST criteria at 24 weeks|up to 24 weeks|||weeks||95% Confidence Interval|Median
769350|NCT00710554|Secondary|Incidence of Adverse Events as a Measure of Subject's Safety.|The number of subjects that reported an adverse event in this study is presented.|19 weeks|All subjects were included in this analysis.||participants|||Number
769351|NCT00710554|Secondary|Change From Baseline in the Use of Rescue Analgesia at the End Treatment (15 Weeks)|Use of break through medication was recorded daily during the study as the number of paracetamol tablets taken. The change in mean daily quantities of tablets used was calculated from baseline to the last seven days of treatment.|Days 0-7 and Days 92-98|The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data.||number of tablets||Standard Deviation|Mean
769352|NCT00710554|Secondary|Change From Baseline in Quality of Life EuroQol 5-D (Health Status Visual Analogue Scale) Score at the End of Treatment (15 Weeks)|The EQ-5D questionnaire provided two outcomes:(1)A weighted health state index visual analogue scale (VAS); (2) A self-rated health status VAS. EQ-5D Health Status VAS Scale: 0 = worst health state imaginable to 100 = best health state imaginable. An increase in score indicates an improvement in condition.|Day 7 and Day 98|The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data.||units on a scale||Standard Deviation|Mean
769353|NCT00710554|Secondary|Change From Baseline in Quality of Life EuroQol 5-D (Health Status Index) Score at the End of Treatment (15 Weeks)|The EQ-5D questionnaire provided two outcomes:(1)A weighted health state index visual analogue scale (VAS); (2) A self-rated health status VAS. EQ-5D Health Status VAS Scale: 0 = worst health state imaginable to 100 = best health state imaginable. An increase in score indicates an improvement in condition.The weighted health state index used the same VAS as above but was calculated for each assessment without imputation to account for missing values i.e., if one or more individual items was missing then the whole index was missing.|Day 7 and Day 98|The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data.||units on a scale||Standard Deviation|Mean
769354|NCT00710554|Secondary|Change From Baseline in Brief Pain Inventory (Short Form) Scores at the End of Treatment|The BPI-SF is a 14-item questionnaire that asks patients to rate pain over the prior week and the degree to which it interferes with activities on a 0 to 10 scale, where 0=no pain and 10=pain as bad as you can imagine. Severity is measured as worst pain, least pain, average pain, and pain right now. The severity composite score was calculated as the arithmetic mean of the four severity items(range 0-10). The minimum value is zero and maximum is 10. A higher score represents a poor outcome.|Day 7 and Day 98|The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data.||units on a scale||Standard Deviation|Mean
769368|NCT00710593|Secondary|Acquisition of HPV-6 DNA by Study Group and Study Visit (Week 48).|Type-specific HPV DNA among subjects who were both HPV DNA negative and HPV sero-negative by study group and study visit at Week 48.|Week 48|||percentage of participants|||Number
769439|NCT00713479|Primary|Systolic Blood Pressure|Systolic blood pressure is evaluated at 15 min intervals under placebo or varenicline in the presence of methamphetamine over 140 minutes post infusion. Data is pooled and the mean and standard deviation are presented.|15 minute intervals|Per protocol||mm Hg|Participants|Standard Deviation|Mean
769355|NCT00710554|Secondary|Subject Global Impression of Change|A 7-point Likert-type scale was used, with the question: ‘Please assess the status of your pain due to peripheral neuropathy since entry into the study using the scale below’ with the markers “very much improved, much improved, slightly improved, no change, slightly worse, much worse or very much worse”. At Visit 2 (Baseline) patients wrote a brief description of their pain caused by peripheral neuropathy which was used at end of treatment to aid their memory regarding their symptoms at study start. For each of above markers the number of participants were reported.|Day 98|The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data.||participants|||Number
769356|NCT00710554|Secondary|Change in Baseline Mean Punctate Allodynia Test Scores at the End of Treatment (15 Weeks)|Punctate allodynia was measured using an in-house built pressure algometer comprising a strain gauge connected to a metal filament with a diameter of 1 mm and blunt tip at baseline and end of study. The filament was manually directed against the skin at an angle of 90 degrees and a steadily increasing pressure applied until the patient verbally indicated that they perceived pain (punctate pressure pain threshold). Patients were asked to verbally rate the intensity of the pain elicited, choosing a number between 0 (no pain)and 10 (most intense pain imaginable).|Day 7 and Day 98|The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data.||units on a scale||Standard Deviation|Mean
769357|NCT00710554|Secondary|Change in Baseline Mean Dynamic Allodynia Test Score at the End of Treatment (15 Weeks)|Dynamic allodynia was assessed by stroking the skin over the affected area five times with a standardised brush, designed specifically for sensory testing at 5 s intervals, and recording the pain severity on a 0–10 point scale (0= no pain to 10 = most pain imaginable). All strokes were of the same length, minimum 2 cm. Each dynamic allodynia score was calculated as the average of the five strokes.A negative change from baseline indicates an improvement in score.|Day 7 and Day 98|The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data.||units on a scale||Standard Deviation|Mean
769358|NCT00710554|Secondary|Change From Baseline in Sleep Quality 0-10 Numerical Rating Scale Scores at the End of Treatment (15 Weeks)|"The sleep disruption NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate how your pain disrupted your sleep last night? where 0 = did not disrupt sleep and 10 = completely disrupted (unable to sleep at all). A negative value indicates an improvement in sleep disruption score from baseline."|Day 7 to Day 98|The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data.||units on a scale||Standard Deviation|Mean
769359|NCT00710554|Secondary|Change From Baseline in Neuropathic Pain Scale Score at the End of Treatment (15 Weeks)|The NPS score is 0-100 sum of 10 individual pain scores (0-10 NRS, 0= no pain to 10 = most pain imaginable). A negative change from baseline indicates an improvement in pain.|Day 7 to Day 98|The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data.||units on a scale||Standard Deviation|Mean
769360|NCT00710554|Primary|Change From Baseline in Mean Peripheral Neuropathic Pain on a 0-10 Numerical Rating Scale (NRS) Score at the End of Treatment (15 Weeks)|"The peripheral neuropathic pain NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain. A negative value indicates an improvement in pain score from baseline."|Day 7 to Day 98|The efficacy analyses were conducted on data from all subjects who were randomised, received at least one dose of study medication and yielded on-treatment efficacy data.||units on a scale||Standard Deviation|Mean
769361|NCT00710593|Secondary|Adverse Events (AE) Reported Among Participants Who Were Randomized to the Telephone Response System (TRS) or Vaccine Report Card (VRC).|Rate of AEs is the total number of AEs divided by the total number of participants. The rate is not a percentage bur rather it could be above 1 or less than 1. This outcome measure looked at number of AEs reported, by grade; number of AEs > Grade 3 identified; and number of AEs > Grade 3 evaluated within 24 or 48 hours.|Day 1 through Week 24|||AEs/Total Number of Participants|||Number
769362|NCT00710593|Secondary|Visit Compliance Via the Telephone Response System (TRS) Versus the Vaccine Report Card.|Visit compliance is the total number of days participants actually called the TRS or completed the VRC divided by the total number of days expected to call the TRS or complete the VRC, multiplied by 100%.|Day 1 through Week 24|||percentage of days||Standard Deviation|Mean
769363|NCT00710593|Secondary|"Need for Safer Sexual Behaviors (NSSB) (Evaluated by Using the 12-item Knowledge About HPV and HPV Vaccine Measure)"|"To characterize young women's risk perceptions, sexual behaviors, and sexually transmitted infections (STI) diagnoses over the 48 weeks after initial vaccination, the relationship of baseline 12-item Knowledge About HPV and HPV Vaccine measure was used to evaluate the need for safer sexual behaviors."|Week 48|Total population analyzed was 99 participants. Percentage of participants reflects percentage of participants in both lower NSSB and higher NSSB.||percentage of participants|||Number
769364|NCT00710593|Secondary|Percentage of Participants Who Reported a Lower Need to Practice Safe Sex Following HPV Vaccination and the Percentage of Participants That Reported a Higher Need to Practice Safe Sex Following HPV Vaccination|"Participants’ perceptions for the need to practice safe sex following HPV vaccination was measured using a safer sexual behaviors subscale, which was comprised of the following five questions:
After getting vaccinated against HPV …
You feel that condom use during sex is less necessary.
You feel it is still just as important to have as few sexual partners as possible.
You feel that it is less important to talk to your sex partners about safe sex.
You think it is still just as important to use a condom every time you have sex.
You will be less worried about having unprotected sex. Those who were categorized in the “lower need for safer sexual behaviors (NSSB)” group had a summary score that was less than the median and those in the “higher NSSB” group had a summary score that was equal to or higher than the median."|Week 48|||percentage of participants|||Number
769369|NCT00710593|Secondary|Acquisition of HPV-18 DNA by Study Group and Study Visit (Week 24).|Type-specific HPV DNA among subjects who were both HPV DNA negative and HPV-18 sero-negative by study group and study visit at Week 24.|Week 24|Subjects who were both Human Papilloma Virus (HPV) Deoxyribonucleic Acid (DNA) negative and HPV-18 sero-negative at Week 24. (The number of participants analyzed for this outcome differs from the number of participants in the Participant Flow Module.)||percentage of participants|||Number
769370|NCT00710593|Secondary|Acquisition of HPV-16 DNA by Study Group and Study Visit (Week 24).|Type-specific HPV DNA among subjects who were both HPV DNA negative and HPV-16 sero-negative by study group and study visit at Week 24.|Week 24|Subjects who were both Human Papilloma Virus (HPV) Deoxyribonucleic Acid (DNA) negative and HPV-16 sero-negative for at Week 24. (The number of participants analyzed for this outcome differs from the number of participants in the Participant Flow Module.)||percentage of participants|||Number
769371|NCT00710593|Secondary|Acquisition of HPV-11 DNA by Study Group and Study Visit (Week 24).|Type-specific HPV DNA among subjects who were both HPV DNA negative and HPV-11 sero-negative by study group and study visit at Week 24.|Week 24|Subjects who were both Human Papilloma Virus (HPV) Deoxyribonucleic Acid (DNA) negative and HPV-11 sero-negative at Week 24. (The number of participants analyzed for this outcome differs from the number of participants in the Participant Flow Module.)||percentage of participants|||Number
769372|NCT00710593|Secondary|Acquisition of HPV-6 DNA by Study Group and Study Visit (Week 24).|Type-specific HPV DNA among subjects who were both HPV DNA negative and HPV-6 sero-negative by study group and study visit at Week 24.|Week 24|Subjects who were both Human Papilloma Virus (HPV) Deoxyribonucleic Acid (DNA) negative and HPV-6 sero-negative at Week 24. (The number of participants analyzed for this outcome differs from the number of participants in the Participant Flow Module.)||percentage of participants|||Number
769373|NCT00710593|Primary|HPV-18 Antibody Level (Geometric Mean Titer of HPV-18)|The outcome measure for the primary objective is immunogenicity as measured by the GMTs of HPV-6, -11, -16, -18 vaccine four weeks after the administration of vaccine dose #3, measured as a continuous variable. Vaccine dose #3 was administered at Week 24.|Week 28|Subjects received the 3rd dose of vaccine and were both Human Papilloma Virus (HPV) Deoxyribonucleic Acid (DNA) negative and HPV-18 sero-negative at baseline (BL).||mMU/mL||Standard Deviation|Geometric Mean
769374|NCT00710593|Primary|HPV-16 Antibody Level (Geometric Mean Titer of HPV-16)|The outcome measure for the primary objective is immunogenicity as measured by the GMTs of HPV-6, -11, -16, -18 vaccine four weeks after the administration of vaccine dose #3, measured as a continuous variable. Vaccine dose # 3 was administered at Week 24.|Week 28|Subjects received the 3rd dose of vaccine and were both Human Papilloma Virus (HPV) Deoxyribonucleic Acid (DNA) negative and HPV-16 sero-negative at baseline (BL).||mMU/mL||Standard Deviation|Geometric Mean
769375|NCT00710593|Primary|HPV-11 Antibody Level (Geometric Mean Titer of HPV-11)|The outcome measure for the primary objective is immunogenicity as measured by the GMTs of HPV-6, -11, -16, -18 vaccine four weeks after the administration of vaccine dose #3, measured as a continuous variable. Vaccine Dose #3 was administered at Week 24.|Week 28|Subjects received the 3rd dose of vaccine and were both Human Papilloma Virus (HPV) Deoxyribonucleic Acid (DNA) negative and HPV-11 sero-negative at baseline (BL).||mMU/mL||Standard Deviation|Geometric Mean
769376|NCT00710593|Secondary|Persistence of Immunogenicity of the HPV-6, -11, -16, and -18 Vaccine 24 Weeks Post Vaccine Dose #3 as Measured by the Geometric Mean Titers (GMT) of HPV-18.|Persistence of immunogenicity as measured by geometric mean titers (GMT) to HPV-6, -11, -16, -18 vaccine 24 weeks after the administration of vaccine dose #3, measured as a continuous variable. Vaccine dose # 3 was administered at Week 24|Week 48|Subjects had received a third dose of vaccination who were both HPV DNA negative and HPV sero-negative at baseline.||mMU/mL||Standard Deviation|Geometric Mean
769377|NCT00710593|Secondary|Persistence of Immunogenicity of the HPV-6, -11, -16, and -18 Vaccine 24 Weeks Post Vaccine Dose #3 as Measured by the Geometric Mean Titers (GMT) of HPV-16.|Persistence of immunogenicity as measured by geometric mean titers (GMT) to HPV-6, -11, -16, -18 vaccine 24 weeks after the administration of vaccine dose #3, measured as a continuous variable. Vaccine dose # 3 was administered at Week 24|Week 48|Subjects had received a third dose of vaccination who were both HPV DNA negative and HPV sero-negative at baseline.||mMU/mL||Standard Deviation|Geometric Mean
769378|NCT00710593|Secondary|Persistence of Immunogenicity of the HPV-6, -11, -16, and -18 Vaccine 24 Weeks Post Vaccine Dose #3 as Measured by the Geometric Mean Titers (GMT) of HPV-11.|Persistence of immunogenicity as measured by geometric mean titers (GMT) to HPV-6, -11, -16, -18 vaccine 24 weeks after the administration of vaccine dose #3, measured as a continuous variable. Vaccine dose # 3 was administered at Week 24|Week 48|Subjects had received a third dose of vaccination who were both HPV DNA negative and HPV sero-negative at baseline.||Milli-Merck units/milliliter (mMU/mL)||Standard Deviation|Geometric Mean
769379|NCT00710593|Secondary|Persistence of Immunogenicity of the HPV-6, -11, -16, and -18 Vaccine 24 Weeks Post Vaccine Dose #3 as Measured by the Geometric Mean Titers (GMT) of HPV-6.|Persistence of immunogenicity as measured by geometric mean titers (GMT) to HPV-6, -11, -16, -18 vaccine 24 weeks after the administration of vaccine dose #3, measured as a continuous variable. Vaccine dose #3 was administered at Week 24.|Week 48|Subjects had received third dose of vaccination who were both HPV DNA negative and HPV sero-negative at baseline.||Milli-Merck units/milliliter (mMU/mL)||Standard Deviation|Geometric Mean
769380|NCT00710593|Secondary|Number of Participants With At Least One Adverse Event Possibly, Probably, or Definitely Related to Vaccine|When a subject had at least one adverse event or sign/symptom during the study after doses 1, 2 or 3, and the event was possibly, probably, or definitely related to vaccine, this subject was considered to have had a vaccine-associated adverse event, sign and/or symptom.|Entry, Week 8, and Week 24|Subjects who had at least one event that was possibly, probably, or definitely related to vaccine.||participants|||Number
769381|NCT00710593|Secondary|Immunogenicity of the HPV-6, -11, -16, -18 Vaccine Four Weeks After Vaccine Dose #3 as Measured as a Binary Variable (Responder vs. Non-responder) for HPV-18|Subjects who had a >= 24 mMU/mL were classified as responders; subjects who had a less than < 24 mMU/mL response were classified as non-responders.|Week 28|Subjects had received third dose of vaccination who were both HPV DNA negative and HPV Sero-Negative at baseline.||participants|||Number
769611|NCT00706134|Primary|Change in Mean Sitting Systolic Blood Pressure (msSBP)From Baseline to End of Study (Week 8)||Baseline to end of study (Week 8)|Full analysis set (FAS) - All randomized patients. Two randomized patients who did not meet study criteria were excluded from the FAS.||mmHg||Standard Error|Least Squares Mean
769382|NCT00710593|Secondary|Immunogenicity of the HPV-6, -11, -16, -18 Vaccine Four Weeks After Vaccine Dose #3 as Measured as a Binary Variable (Responder vs. Non-responder) for HPV-16|Subjects who had a >= 20 mMU/mL were classified as responders; subjects who had a less than < 20 mMU/mL response were classified as non-responders.|Week 28|Subjects had received third dose of vaccination who were both HPV DNA negative and HPV Sero-Negative at baseline.||participants|||Number
769383|NCT00710593|Secondary|Immunogenicity of the HPV-6, -11, -16, -18 Vaccine Four Weeks After Vaccine Dose #3 as Measured as a Binary Variable (Responder vs. Non-responder) for HPV-11|Subjects who had a >= 16 mMU/mL were classified as responders; subjects who had a less than < 16 mMU/mL response were classified as non-responders.|Week 28|Subjects had received third dose of vaccination who were both HPV DNA negative and HPV Sero-Negative at baseline.||participants|||Number
769384|NCT00710593|Secondary|Immunogenicity of the HPV-6, -11, -16, -18 Vaccine Four Weeks After Vaccine Dose #3 as Measured as a Binary Variable (Responder vs. Non-responder) for HPV-6|Subjects who had a greater than or equal to (>=) 20 Milli-Merck units (mMU)/milliliter (mL) response were classified as responders; subjects who had a less than (<) 20 mMU/mL response were classified as non-responders.|Week 28|Subjects had received third dose of vaccination who were both Human Papilloma Virus (HPV) Deoxyribonucleic Acid (DNA) negative and HPV Sero-Negative at baseline.||participants|||Number
769385|NCT00710593|Primary|HPV-6 Antibody Level (Geometric Mean Titer of HPV-6)|The outcome measure for the primary objective is immunogenicity as measured by the GMT of HPV-6, -11, -16, -18 vaccine four weeks after the administration of vaccine dose #3, measured as a continuous variable. Vaccine dose # 3 was administered at Week 24.|Week 28|Subjects received the 3rd dose of vaccine and were both Human Papilloma Virus (HPV) Deoxyribonucleic Acid (DNA) negative and HPV-6 sero-negative at baseline (BL).||Milli-Merck units/milliliter (mMU/mL)||Standard Deviation|Geometric Mean
769386|NCT00710606|Secondary|Mean Endometrial Proliferation|The mean endometrial proliferation from week 1, week 2 and week3|Transvaginal ultrasound measurements of endometrial proliferation will be completed over continuous ring use, an average of 3 weeks|17 participants in each group was planned a priori to have 80% power to identify a one standard deviation difference in the mean serum levels of the contraceptive hormones. We enrolled 40 women, 2 withdrew prior to the study cycle. We excluded one woman due to removal of the CVR during the study cycle leaving 18 normal weight and 19 obese women.||millimeters||Standard Deviation|Mean
769387|NCT00710606|Secondary|Number of Participants Achieving a Maximum Follicle Diameter > 13mm During the 3 Weeks of Follow-up|Follicular development was minimal in both groups, with only five women achieving a maximum follicle diameter > 13mm at any time during the 3 weeks of follow-up (3 normal weight and 2 obese women).|continuous ring use, an average of 3 weeks|17 participants in each group was planned a priori to have 80% power to identify a one standard deviation difference in the mean serum levels of the contraceptive hormones. We enrolled 40 women, 2 withdrew prior to the study cycle. We excluded one woman due to removal of the CVR during the study cycle leaving 18 normal weight and 19 obese women.||Participant w/follicular diameter >=13mm|||Number
769388|NCT00710606|Primary|Mean Serum Concentrations of Etonogestrel and Ethinyl Estradiol|Serum concentrations were obtained from thirty-seven women completed follow-up.|Measurements at Week 3 and Week 6 continuous ring use|17 participants in each group was planned a priori to have 80% power to identify a one standard deviation difference in the mean serum levels of the contraceptive hormones. We enrolled 40 women, 2 withdrew prior to the study cycle. We excluded one woman due to removal of the CVR during the study cycle leaving 18 normal weight and 19 obese women.||ng/L||95% Confidence Interval|Geometric Mean
769389|NCT00710749|Primary|Mean Urine Flow Rate|Measurements with a disposable device and the current clinic gold standard measurement were compared to test the hypothesis that three repeated measurements with the disposable device was as accurate as one clinic flow measurement. A digital device was used as a reference of the most exact way to evaluate each patient's individual flow.|At every voiding event during approximately one week.|Intention to treat analysis. Number of participants analyzed differs between groups since data was missing mainly due to technical problems.||ml/s||Standard Deviation|Mean
769390|NCT00710762|Secondary|Clinical Relevant Abnormalities for Laboratory Parameters|Clinical Relevant Abnormalities for laboratory parameters. Any new or clinically relevant worsening of baseline conditions was reported as Adverse Events.|First drug administration until 28 days after last drug administration, up until 309 days|Treated set||Percentage of participants|||Number
769391|NCT00710762|Secondary|Incidence and Intensity of Adverse Events With Grading According CTCAE|Incidence and intensity of Adverse Events with grading according to the Common Terminology Criteria for Adverse Events (CTCAE version 3.0).|First drug administration until 28 days after last drug administration,up until 309 days|Treated set||percentage of participants|||Number
769392|NCT00710762|Secondary|Time to Death|This end point was not determined as no patients died during the trial.|9 months|This endpoint could not be calculated as no patients died.|||||
769393|NCT00710762|Secondary|Time to Tumour Progression|"Time to Tumour Progression according to RECIST version 1.0 , CA-125 (ovarian tumour marker) levels and RECIST + CA-125 levels.
For CA-125, progressive disease was defined on the basis of progressive serial elevations of CA-125 according to the following criteria:
Patients with elevated CA-125 pre-treatment and normalisation of CA-125 had to show evidence of CA-125 levels ≥2 x ULN on 2 occasions at least 1 week apart. or Patients with elevated CA-125 pre-treatment that never normalised had to show evidence of CA-125 levels ≥2 x the nadir value on 2 occasions at least 1 week apart. or Patients with CA-125 in the normal range pre-treatment had to show evidence of CA-125 levels ≥2 x ULN on 2 occasions at least 1 week apart.
Composite (RECIST+CA-125) endpoint is the RECIST progressive disease (PD) if it occurred or the CA-125 PD if it occurred in the absence of RECIST PD."|9 months|Treated set||days||95% Confidence Interval|Median
769394|NCT00710762|Secondary|PFS Rate at 12 Weeks (After 3 Months) and 24 Weeks ( After 6 Months)|The rate (probability) of being progression free at Week 12 and Week 24. Progression Free Survival (PFS) was defined according to RECIST version 1.0 from the time of first study drug administration to the first time of either objective tumour progression, the appearance of ≥1 new tumour lesion(s), occurrence or significant progression of malignant ascites, tumour related death, or the time when patients were censored at last known follow up. The rate is the Kaplan-Meier estimated percent probability.|12 weeks (after 3 months) and 24 weeks ( after 6 months)|Treated set||percent probability of PFS||95% Confidence Interval|Number
769612|NCT00706329|Secondary|At Follow up if the Hernia Has Not Closed, Another Surgery May be Required to Close the Umbilical Hernia.||Seven or more months after initial surgery.||||||
769395|NCT00710762|Primary|PFS Rate at 36 Weeks (After 9 Months)|The rate (probability) of being progression free at Week 36. Progression Free Survival (PFS) was defined according to RECIST version 1.0 from the time of first study drug administration to the first time of either objective tumour progression, the appearance of ≥1 new tumour lesion(s), occurrence or significant progression of malignant ascites, tumour related death, or the time when patients were censored at last known follow up. The rate is the Kaplan-Meier estimated percent probability.|36 weeks (after 9 months)|Treated set.||percent probability of PFS||95% Confidence Interval|Number
769396|NCT00710814|Primary|Weight Change (in kg.) After Each Intervention|"For the Leptin Intervention, 16 week values were compared to baseline for those who received Leptin in the first period, and 32 week values were compared to 16 week values in those who received Leptin in the second period.
For the Placebo Intervention, 16 week values were compared to baseline for those who received Placebo in the first period, and 32 week values were compared to 16 week values in those who received Placebo in the second period."|0 weeks, 16 weeks and 32 weeks|||kg weight change||95% Confidence Interval|Mean
769397|NCT00710840|Secondary|Functional Performance: Stair Climb Test|This outcome measures the time (seconds) it takes to climb up and back down 12 steps.|Measured pre-operatively; post-surgery at 4 weeks and 12 weeks|||Seconds||Standard Deviation|Mean
769398|NCT00710840|Primary|Knee Range of Motion|Knee Flexion Active Range of Motion (AROM)|Measured pre-operatively; post-surgery at 4 weeks and 12 weeks|||degrees||Standard Deviation|Mean
769399|NCT00710840|Secondary|Functional Performance: 6 Minute Walk (6MW) Distance||Measured pre-operatively; post-surgery at 4 weeks and 12 weeks|||Meters||Standard Deviation|Mean
769400|NCT00710840|Primary|Quadriceps Muscle Force||Measured pre-operatively; post-surgery at 4 weeks and 12 weeks|||Nm/kg||Standard Deviation|Mean
769401|NCT00712725|Secondary|Sustained Pain Freedom (SPF)|Pain freedom (Grade 0) at 2 hours postdose, with no administration of any rescue medication and no occurrence thereafter of a mild/moderate/severe headache during the 2 to 24 hours after dosing with study medication.|2-24 hours postdose|Full Analysis Set (FAS), which included all randomized participants who met the FAS criteria for PF at 2 hours postdose, and who, between 2-24 hours posedose, either 1) did not have PF at any time, 2) used rescue, or 3) answered the 24 hour recurrence question.||Participants|||Number
769402|NCT00712725|Secondary|Absence of Nausea|Absence of nausea at 2 hours postdose as recorded by patient on paper diary.|2 hours postdose|Full Analysis Set (FAS), which included all randomized participants who administered study treatment, had both a baseline severity measurement and at least one postdose efficacy measurement prior to or including the 2-hour time point.||Participants|||Number
769403|NCT00712725|Secondary|Absence of Phonophobia|Absence of phonophobia at 2 hours postdose as recorded by patient on paper diary.|2 hours postdose|Full Analysis Set (FAS), which included all randomized participants who administered study treatment, had both a baseline severity measurement and at least one postdose efficacy measurement prior to or including the 2-hour time point.||Participants|||Number
769404|NCT00712725|Secondary|Absence of Photophobia|Absence of photophobia at 2 hours postdose as recorded by patient on paper diary.|2 hours postdose|Full Analysis Set (FAS), which included all randomized participants who administered study treatment, had both a baseline severity measurement and at least one postdose efficacy measurement prior to or including the 2-hour time point.||Participants|||Number
769405|NCT00712725|Secondary|Pain Relief (PR)|"Reduction of a Grade 2 or 3 severity migraine at baseline to mild or no pain (Grade 1 or 0) at 2 hours postdose.
Rating of Headache Severity (Scale from Grade 0 to 3):
Grade 0: No pain
Grade 1: Mild pain
Grade 2: Moderate pain
Grade 3: Severe pain"|2 hours postdose|Full Analysis Set (FAS), which included all randomized participants who administered study treatment, had both a baseline severity measurement and at least one postdose efficacy measurement prior to or including the 2-hour time point.||Participants|||Number
769406|NCT00712725|Primary|Pain Freedom (PF)|"Reduction of a Grade 2 or 3 severity migraine at baseline to Grade 0 at 2 hours postdose.
Rating of Headache Severity (Scale from Grade 0 to 3):
Grade 0: No pain
Grade 1: Mild pain
Grade 2: Moderate pain
Grade 3: Severe pain"|2 hours postdose|Full Analysis Set (FAS), which included all randomized participants who administered study treatment, had both a baseline severity measurement and at least one postdose efficacy measurement prior to or including the 2-hour time point.||Participants|||Number
769407|NCT00712920|Secondary|Change From Baseline on Direct Visual Nasal Exams and 28 Days|Examination of head and neck (scale: None, Mild, Moderate, Severe) for Epistaxis, Mucosal Edema, Nasal Discharge, Mucosal erythema, Mucosal Bleeding, and Crusting of mucosa. Nasal irratation was rated: 0 = None, Grade 1A = focal irritation, Grade 1B = superficial mucosal erosion, Grade 2 = moderate mucosal erosion, Grade 3 = ulceration, Grade 4 = septal perforation|baseline and 28 days|ITT||Participants|||Number
769408|NCT00712920|Secondary|Change From Baseline in Rinoconjunctivitis Quality of Life Questionnaire and 28 Days|A 28-item RQLQ was completed on Day 1 and Day 28 or Early temination. The RQLQ consists of 7 domains rated on a 7 point scale with 0 being not troubled by the allergy symptoms, and 6 being extremely troubled/all of the time. Domain score will be calculated from the mean score of all items in the domain. Overall score will be calculated from the mean score of all items.|baseline and 28 Days|ITT||Units on a Scale||Standard Deviation|Least Squares Mean
769409|NCT00712920|Secondary|Change From Baseline in 12-hour Reflective Secondary Symptom Complex Score Compared to Placebo (AM and PM Combined)and 28 Days|Reflective secondary symptom complex scores (SSCS) (post-nasal drip, itchy eyes, cough and headacdhe) were assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible SSCS score is 24 per day.|baseline and 28 days|ITT||Scores on a Scale||Standard Deviation|Least Squares Mean
769410|NCT00712920|Secondary|Change From Baseline in Instantaneous Total Nasal Symprom scoreS Compared to Placebo (AM and PM Combined)and 28 Days|"instantaneous (subjects rate how they feel right now) total nasal symptom score consisting of runny nose, itchy nose, nasal congestion, and sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible score is 24 per day."|baseline and 28 days|ITT||Scores on a Scale||Standard Deviation|Least Squares Mean
769436|NCT00713479|Secondary|Depression|Using the Beck Depression Index (BDI-II), depression was assessed on a daily basis. The daily mean score during the medication intervention period is presented, with a lower score indicating lower reported depression. The scores range from 0–13: minimal depression; 14–19: mild depression; 20–28: moderate depression; and 29–63: severe depression.|Daily|||units on a scale|Participants|Standard Deviation|Mean
769411|NCT00712920|Primary|Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (AM and PM Combined) at 28 Days.|"Reflective total nasal symptom score consisting of Runny nose, itchy nose, nasal Congestion, and Sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible score is 24 per day
Least square means (LS Mean) was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate."|baseline and 28 days|ITT||Scores on a Scale|||Number
769412|NCT00712959|Other Pre-specified|Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL® 10 Years After a Previous Dose|"Solicited Injection Site Reactions: Pain, Erythema, and swelling. Solicited Systemic Reactions: Fever (temperature), Headache, Malaise, and Myalgia.
Grade 3 - Pain: Incapacitating, : Incapacitating, unable to perform usual activities, may have/or required medical care or absenteeism; Erythema and Swelling: ≥5 cm; Fever: > 39.0°C, Headache, Malaise, and Myalgia Prevents daily activities."|Day 0 up to Day 7 post-vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.||Participants|||Number
769413|NCT00712959|Other Pre-specified|Geometric Mean Concentrations Against Tetanus and Diphtheria Antigens Before and Post-vaccination With ADACEL® 10 Years After a Previous Dose|Post-vaccination geometric mean concentrations (GMCs) for Diphtheria was determined by neutralization assay; GMCs for tetanus was determined by enzyme-linked immunosorbent assay (ELISA).|Day 0 (pre-vaccination) and Day 30 post-vaccination|Geometric mean concentrations were assessed in the per-protocol population.||IU/mL||95% Confidence Interval|Geometric Mean
769414|NCT00712959|Other Pre-specified|Geometric Mean Concentrations Against Pertussis Antigens Before and Post-vaccination With ADACEL® 10 Years After a Previous Dose|Post-vaccination geometric mean concentrations (GMCs) against pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN), and fimbriae types 2 and 3 (FIM), were determined by enzyme-linked immunosorbent assay (ELISA).|Day 0 (pre-vaccination) and Day 30 post-vaccination|Geometric mean concentrations were assessed in the per-protocol population.||EU/mL||95% Confidence Interval|Geometric Mean
769415|NCT00712959|Other Pre-specified|Percentage of Participants Achieving Booster Response for Each Anti-Pertussis Antibody Following Revaccination With ADACEL® 10 Years After a Previous Dose|"Booster response for each anti-pertussis antibody was defined as a post-vaccination antibody concentration:
≥ 4 x the Lower limit of quantitation (LLOQ), if the pre-vaccination concentration was < LLOQ; or
≥ 4 x the pre-vaccination antibody concentration, if the pre-vaccination concentration was ≥ LLOQ but < 4 x LLOQ; or
≥ 2 x the pre-vaccination antibody concentration, if the pre-vaccination concentration was ≥ 4 x LLOQ."|Day 30 post-vaccination|Booster response for each anti-Pertussis antibody was assessed in the per-protocol population.||Percentage of Particpants|||Number
769416|NCT00712959|Other Pre-specified|Percentage of Participants Achieving Booster Response of Anti-Tetanus and Anti-Diptheria Following Revaccination With ADACEL® 10 Years After a Previous Dose|"Anti-diphtheria or anti-tetanus booster responses were defined as:
Pre-vaccination antibody concentrations of < 0.1 IU/mL and a post-vaccination levels ≥ 0.4 IU/mL; or a pre-vaccination antibody concentrations of ≥ 0.1 IU/mL to < 2 IU/mL and a 4-fold rise; or pre-vaccination antibody concentrations of ≥ 2.0 IU/mL and a 2-fold response."|Day 30 post-vaccination|Booster Response to Tetanus and Diptheria antigens were assessed in the per-protocol population.||Percentage of Participants|||Number
769417|NCT00712959|Primary|Anti-Pertussis Geometric Mean Concentrations Post-vaccination With ADACEL® 10 Years After a Previous Dose|Post-vaccination geometric mean concentrations (GMCs) for pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN), and fimbriae types 2 and 3 (FIM), were determined by enzyme-linked immunosorbent assay (ELISA).|Day 30 post-vaccination|Geometric mean concentrations were assessed in the per-protocol population.||EU/mL||95% Confidence Interval|Geometric Mean
769418|NCT00712959|Primary|Percentage of Participants With Seroprotection Against Tetanus and Diphtheria Before and After Revaccination With ADACEL® 10 Years After a Previous Dose|"Diphtheria concentrations were determined by neutralization assay; tetanus concentrations were determined by enzyme-linked immunosorbent assay (ELISA).
Seroprotection was defined as anti-tetanus or anti-diphtheria concentrations ≥ 0.1 IU/mL."|Day 0 (pre-vaccination) and 30 post-vaccination|Anti-tetanus and anti-diphtheria concentrations were assessed in the per-protocol population.||Percentage of Participants|||Number
769419|NCT00712985|Primary|Number of Participants With Urine and Serum NTx and Serum CTx Within Normal Range at 12 Months|17 women with early breast cancer receiving adjuvant Aromatase Inhibitor (AI) therapy were treated with a single 5 mg IV dose of zoledronic acid. Urine and serum NTx and serum CTx were measured at baseline and month 12.|One year|||participants|||Number
769420|NCT00713206|Secondary|Crestal Bone Regression||four years||12/2017||||
769421|NCT00713206|Primary|Integration Success of Implant|Number of enrolled and treated patients with integrated implants (no mobility detected) at time of analysis|3 year|Number of participants used in analysis selected as per protocol||participants|Number of implants analyzed||Number
769422|NCT00713219|Primary|Overall Progression-Free Survival (PFS).|Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measureable increase in a non-target lesion, or the appearance of new lesions.|conclusion of the study|||Days||Full Range|Mean
769423|NCT00713258|Secondary|Change in Physical Disability and Patient Reported Outcomes During 24 Weeks of Treatment|"Three times during the trial the patients will be asked how their pain affects their ability to manage everyday life. This information will be collected by use of the Oswestry Disability Index (ODI) questionnaire. The questions relate to daily life activities and indicate to what extent a person’s functional level is restricted by pain.
ODI scores from 0 = no disability to 100 = maximum disability.
Patient reported outcomes will be assessed by using two questionnaires related to health status and quality of life status."|Baseline and 24 weeks treatment|"The number of participants analyzed is 0, because the reduction of the sample size from 300 to 75 subjects due to early trial termination resulted in a small number of subjects with data available. This is far below the number needed to demonstrate a significant difference between the comparison groups and the data have no statistical validity."||scores on a scale||Standard Deviation|Mean
769437|NCT00713479|Primary|Heart Rate|Heart rate is evaluated at 15 min intervals under placebo or varenicline in the presence of methamphetamine over 140 minutes post infusion. Data is pooled and the mean and standard deviation are presented.|15 minute intervals|||bpm|Participants|Standard Deviation|Mean
769424|NCT00713258|Primary|Change in Back Pain Intensity During 24 Weeks of Treatment Using a Numerical Rating Scale.|The daily patient assessment of intensity of back pain is based on the Numerical Rating Scale (NRS) which is an 11-point numerical rating scale (from 0-10 with 0 = “no pain” and 10 = “unendurable pain”).|Baseline and 24 weeks treatment|"The number of participants analyzed is 0, because the reduction of the sample size from 300 to 75 subjects due to early trial termination resulted in a small number of subjects with data available. This is far below the number needed to demonstrate a significant difference between the comparison groups and the data have no statistical validity."||points on a scale||Standard Deviation|Mean
769425|NCT00713310|Secondary|Treatment Success PUCAI Amended Endpoint (5 Point Scale Abdominal Pain), mITT|PUCAI 0-85, abdominal pain amended (no pain/0, very mild/2.5, mild/5, moderate/7.5, severe/10), rectal bleeding (none/0, small <50% stool/10, small with most stools/20, large >50% stool/30), stool consistency (formed/0, partially/5, unformed/10), # per 24 hrs (0-2/0, 3-5/5, 6-8/10, >8/15), nocturnal bowel movements (no/0, yes/10), activity level (no limitation/0, occasional limitation/5, severely restricted/10) Remission <10, Mild 10-34, Moderate 35-64, Severe 65-85, Success score<10 at Wk 6 (complete) or reduction of >=20 points baseline to Wk 6 with Wk 6 score>=10 (partial)|Baseline and Week 6|mITT subjects who were randomized & took at least one dose of study medication||% participants with treatment success|||Number
769426|NCT00713310|Primary|Treatment Success PUCAI (Pediatric Ulcerative Colitis Activity Index), mITT/Modified Intent to Treat Population|PUCAI 0-85, abdominal pain (no pain/0, pain ignored/5, pain not ignored/10), rectal bleeding (none/0, small <50% stool/10, small with most stools/20, large >50% stool/30), stool consistency (formed/0, partially/5, unformed/10), # per 24 hrs (0-2/0, 3-5/5, 6-8/10, >8/15), nocturnal bowel movements (no/0, yes/10), activity level (no limitation/0, occasional limitation/5, severely restricted/10) Remission <10, Mild 10-34, Moderate 35-64, Severe 65-85, Success score<10 at Wk 6 (complete) or reduction of >=20 points baseline to Wk 6 with Wk 6 score>=10 (partial)|Baseline and 6 weeks|miTT includes subjects who were randomized and took at least one dose of study medication||% participants with treatment success|||Number
769427|NCT00713323|Secondary|Change From Parent Study Baseline in Mean Intoxication 0-10 Numerical Rating Scale Score at the End of Open-label Treatment (38 Weeks)|"The patient was asked on a scale of ‘0 to 10’ please indicate the average level of your intoxication due to medications over the last 24 hours (0=no intoxication and 10=extreme toxication). A negative value indicates an improvement in pain score from baseline."|38 weeks|All subjects who received at least one dose of open-label Sativex were included in the analysis.||units on a scale||Standard Deviation|Mean
769428|NCT00713323|Secondary|Incidence of Adverse Events as a Measure of Subject Safety|The number of subjects who reported an adverse event during Part A of the study is presented (including the follow-up period of 28 days following cessation of opel-label treatment).|42 weeks|All subjects who received at least one dose of open-label Sativex were included in the analysis.||participants|||Number
769429|NCT00713323|Secondary|Change From Parent Study Baseline in Mean EuroQol-5D Self-rated Health Status Visual Analogue Scale Score at the End of Open-label Treatment|The EQ-5D questionnaire provided two outcomes:(1)A weighted health state index visual analogue scale (VAS); (2) A self-rated health status VAS. EQ-5D Health Status VAS Scale: 0 = worst health state imaginable to 100 = best health state imaginable. An increase in score indicates an improvement in condition.|38 weeks|All subjects who received at least one dose of open-label Sativex were included in the analysis.||units on a scale||Standard Deviation|Mean
769430|NCT00713323|Secondary|Change From Parent Study Baseline in Mean EuroQol-5D Weighted Health State Index Score at the End of Open-label Treatment|The EQ-5D questionnaire provided two outcomes:(1)A weighted health state index visual analogue scale (VAS); (2) A self-rated health status VAS. EQ-5D Health Status VAS Scale: 0 = worst health state imaginable to 100 = best health state imaginable. An increase in score indicates an improvement in condition.The weighted health state index used the same VAS as above but was calculated for each assessment without imputation to account for missing values i.e., if one or more individual items was missing then the whole index was missing.|38 weeks|All subjects who received at least one dose of open-label Sativex were included in the analysis.||units on a scale||Standard Deviation|Mean
769431|NCT00713323|Secondary|Subject Global Impression of Change|A 7-point Likert-type scale was used, with the question: ‘Please assess the status of your pain since entry into the study using the scale below’ with the markers “very much improved, much improved, slightly improved, no change, slightly worse, much worse or very much worse”. At Visit 2 (Baseline) patients wrote a brief description of their pain which was used at Week 5 to aid their memory regarding their symptoms at study start. For each of above markers the number of participants were reported.|week 38|All subjects who received at least one dose of open-label Sativex were included in the analysis.||participants|||Number
769432|NCT00713323|Secondary|Change From Parent Study Baseline in Mean Sleep Quality 0-10 NRS Score at the End of Open-label Treatment (Week 38)|"The sleep disruption NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate how your pain disrupted your sleep last night? where 0 = did not disrupt sleep and 10 = completely disrupted (unable to sleep at all). A negative value indicates an improvement in sleep disruption score from baseline."|38 weeks|All subjects who received at least one dose of open-label Sativex were included in the analysis.||units on a scale||Standard Deviation|Mean
769433|NCT00713323|Secondary|Change From Parent Study Baseline in Mean Neuropathic Pain Scale (NPS) Score at End of Open-label Treatment (Week 38)|The NPS score is 0-100 sum of 10 individual pain scores (0-10 NRS, 0= no pain to 10 = most pain imaginable). A negative change from baseline indicates an improvement in pain.|38 weeks|All subjects who received at least one dose of open-label Sativex were included in the analysis.||units on a scale||Standard Deviation|Mean
769434|NCT00713323|Primary|Change From Parent Study Baseline in Mean Pain 0-10 Numerical Rating Scale (NRS) Score During the Last 4 Weeks of Open-label Treatment|"The average pain NRS was complete at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain. A negative value indicates an improvement in pain score from baseline."|38 weeks|All subjects who received at least one dose of open-label Sativex were included in the analysis.||units on a scale||Standard Deviation|Mean
769435|NCT00713349|Primary|Complete Wound Closure|Each subject acting as their own control|21 Days|||days||Standard Deviation|Mean
769440|NCT00713544|Secondary|Health Assessment Questionnaire - Disability Index (HAQ-DI)|Change from baseline in HAQ-DI (a measure of patients assessment of physical function scored between zero and 3) after 6 months’ treatment, calculated as score at 12 Weeks minus score at baseline. A change of zero indicates no effect of treatment and a negative change of 0.22 or greater indicates an improvement in symptoms. The HAQ-DI scale runs from 0 to 3, with higher scores indicating greater disability.|Baseline to 12 Weeks|||Units on a scale||Standard Deviation|Mean
769441|NCT00713544|Secondary|Disease Activity Score (Based on 28 Joint Count) (DAS28)|Change from baseline in the DAS28 composite score (a measure of RA symptoms including: joint swelling and tenderness; patient’s assessment of disease activity; and ESR) after 12 Weeks’ treatment. A change of zero indicates no effect of treatment and a negative change of 1.2 indicates a clinically important improvement in symptoms. The DAS scale runs from 0 to 10, with the higher scores indicating worse RA symptoms.|Baseline to 12 Weeks|||Units on a scale||Standard Deviation|Mean
769442|NCT00713544|Secondary|American College of Rheumatology 70 Response (ACR70)|The number of participants with greater to or equal to 70% improvement in the ACR composite score (a measure of RA symptoms including: joint swelling and tenderness; patient’s assessment of pain, disease activity and physical function; physician’s assessment of disease activity; and CRP) after 12 Weeks’ treatment.|12 weeks|||Participants|||Number
769443|NCT00713544|Secondary|American College of Rheumatology 50 Response (ACR50)|The number of participants with greater to or equal to 50% improvement in the ACR composite score (a measure of RA symptoms including: joint swelling and tenderness; patient’s assessment of pain, disease activity and physical function; physician’s assessment of disease activity; and CRP) after 12 Weeks’ treatment.|12 weeks|||Participants|||Number
769444|NCT00713544|Primary|American College of Rheumatology 20 Response (ACR20)|The number of participants with greater to or equal to 20% improvement in the ACR composite score (a measure of RA symptoms including: joint swelling and tenderness; patient’s assessment of pain, disease activity and physical function; physician’s assessment of disease activity; and CRP) after 12 Weeks’ treatment.|12 weeks|||Participants|||Number
769445|NCT00713596|Primary|Patient Assessments of Disease-specific Quality of Life, Nasal Symptoms, and Nasal Form at 6 Months as Measured by Rhinoplasty Outcomes Evaluation (ROE), Nasal Obstructive Symptoms Evaluate Scale (NOSE), and Global Measure of Nose Deformity|"ROE: 6 items for subject's opinion re: nasal appearance, each item on 0-4 scale. Total score sum of 6 items, dividing total by 24 X 100, core ranges from 0 (least satisfied) to 100 (most satisfied).
NOSE: Assess five conditions over the past month, each item on 0-4 scale X 5, then summed. Total score ranges from 0 (no problem) to 100 (severe problem).
Global measure of nose deformity: Pictures of 4 indices of nasal anatomy: length, width, tip, and hump. Each index cored from 1-7, with 1=ideal nose, and 7=deformed nose. Total score = sum of 4 indices, range 4-28, lower score=more ideal nose"|6 months post operative||||||
769446|NCT00713596|Secondary|Assessment of the Results of Surgery 6 Months Post Operative by Review of Post Operative Photographs by the Operating Surgeon and 3 Blinded Reviewers Using a Mayo Clinic Surgeon Septorhinoplasty Questionnaire|At the end of the study standard post operative rhinoplasty photos will be obtained, and the photos will be reviewed by three blinded observers, who are experienced rhinoplasty surgeons. The photos will be presented to the evaluators in a completely random fashion at a single session. These photos will be graded at that time using the same questionnaire used by the operating surgeon. The questionnaire covers bruising, swelling, tenderness, and length, width, hump and tip of nose, with a range 4-40, 4=ideal nose to 40=many postoperative problems and disfigured nose.|6 months postoperative||||||
769447|NCT00713609|Secondary|Proportion of Participants With an ISGA Score of 0 or 1 at Week 12|An ISGA was obtained at Baseline and at Weeks 2, 4, 8, and 12. The scores range from 0-5 (0=clear skin with no inflammatory or non-inflammatory lesions; 5=very severe with many non-inflammatory and inflammatory lesions and more than a few nodular lesions (may have cystic lesions). The higher score indicates more severe. The area considered for the ISGA was confined to the face. When possible, the same efficacy assessor performed all ISGA assessments on the same participant at all visits. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified time points were analyzed.|Week 12|ITT Analysis Set||Percentage of participants|||Number
769448|NCT00713609|Secondary|Percent Change From Baseline to Week 12 in Each of 3 Lesion Counts (Total, Inflammatory, and Non-inflammatory)|The investigator or designee took count of inflammatory lesions (papules, pustules, nodules and cysts) (ILC), noninflammatory lesions (open and closed comedones) (NILC) and total lesions (TLC) at Baseline, Weeks 2, 4, 8, and 12. Lesion counts were confined to the face. Each of 3 lesion counts (total, inflammatory and non-inflammatory) was analyzed using an analysis of covariance (ANCOVA) model with terms for treatment, center, Baseline value and treatment-by-center interaction. If the interaction was not significant at 0.1 level, this interaction was excluded in ANCOVA model. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified timepoints were analyzed (represented by n=X in the category titles).|Baseline and up to Week 12|ITT Analysis Set||Percent change||Standard Deviation|Mean
769449|NCT00713609|Primary|Proportion of Participants With a Minimum 2-grade Improvement in the Investigator’s Static Global Assessment (ISGA) Score From Baseline to Week 12|An ISGA was obtained at Baseline and at Weeks 2, 4, 8, and 12. The scores range from 0-5 (0=clear skin with no inflammatory or non-inflammatory lesions; 5=very severe with many non-inflammatory and inflammatory lesions and more than a few nodular lesions (may have cystic lesions). The higher score indicates more severe. The area considered for the ISGA was confined to the face. When possible, the same efficacy assessor performed all ISGA assessments on the same participant at all visits. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified time points were analyzed.|Baseline and up to Week 12|ITT Analysis Set||Percentage of participants|||Number
769458|NCT00713700|Primary|The Primary Safety Endpoint is the Rate of Device and Procedure Related Serious Adverse Events (SAE) 180 Days Post Procedure.|"The primary safety endpoint is the rate of device and/or procedure related SAEs reported in subjects whom device placement is attempted from the procedure through 180 days post procedure
SAEs are defined as: Adverse events resulting in the following; death, life-threatening adverse event, inpatient hospitalization or prolongation of existing hospital stay, persistent or significant disability/incapacity or medically significant event."|180 days|Of the 192 enrolled subjects, 188 completed follow-up through 180 days post procedure;3 subjects were lost to follow-up (LTFU) before the 180-day interval and 1 subject was discontinued at the end of the 6-month visit without follow-up.||percentage of participants||95% Confidence Interval|Number
769450|NCT00713609|Primary|Absolute Change in Lesion Counts (Total, Inflammatory, and Non-inflammatory) From Baseline to Week 12|The investigator or designee took count of inflammatory lesions (papules, pustules, nodules and cysts [only post-Baseline]) (ILC), noninflammatory lesions (open and closed comedones) (NILC) and total lesions (TLC) at Baseline, Weeks 2, 4, 8, and 12. Lesion counts were confined to the face. Each of 3 lesion counts (total, inflammatory and non-inflammatory) was analyzed using an analysis of covariance (ANCOVA) model with terms for treatment, center, Baseline value and treatment-by-center interaction. If the interaction was not significant at 0.1 level, this interaction was excluded in ANCOVA model. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified timepoints were analyzed (represented by n=X in the category titles).|Baseline and up to Week 12|Intent-to-treat (ITT) Analysis Set: all randomized participants who received study product and reached Week 12.||Lesion count||Standard Deviation|Mean
769451|NCT00713648|Secondary|Number of Subjects With rFXIII Antibody Development|Subjects receiving rFXIII were monitored for the development of binding antibodies. Blood sampling was done before administration of trial product at all visits (Visits 1-16 and unscheduled visit)|For a period of 322 days (approximately one year) comprised of a screening visit (Visit 1), treatment period (Visits 2-15), unscheduled visit and end-of-trial visit (Visit 16).|Full analysis set - Subjects who received at least one dose of trial product.||participants|||Number
769452|NCT00713648|Secondary|Level of FXIII Activity One Hour After rFXIII Administration and 28 Days After rFXIII Administration for All Dosing Visits|Subjects entered a 52-week treatment period of monthly (28±2 days) doses of 35 IU/kg rFXIII. Blood samples for analysis of FXIII activity were drawn at each visit; at dosing visits blood was drawn 1 hour after administration and before administration(corresponding to 28 days after the previous dose). All Dosing Visits are visits where a dose is given (i.e. Visit 2-15 except Visit 3).|For a period of 322 days (approximately one year) comprised of a screening visit (Visit 1), treatment period (Visits 2-15), unscheduled visit and end-of-trial visit (Visit 16).|Full analysis set - consisting of a total of 41 subjects who received at least one dose of trial product. For All Dosing Visits, the participants analyzed (N) are the 'All Visit Subjects Count' i.e. the sum of subject counts across all dosing visits combined.||U/kg||Standard Deviation|Mean
769453|NCT00713648|Secondary|Percentage of Subjects Having a Normal Clot Solubility One Hour After rFXIII Administration and 28 Days After rFXIII Administration for All Dosing Visits|Blood samples for clot solubility drawn at each visit (1 hour before and after dose administration). A clot solubility assay was used to screen for FXIII deficiency. The assay is based on the ability of urea to dissolve fibrin clots that have not undergone FXIII-induced stabilization. Normal blood clots generally remain stable for 24 hours or more, while clots in which fibrin molecules have not been cross-linked are soluble within minutes. The outcome of the test is normal (FXIII present; a clot is observed in the test tube) or abnormal (FXIII absent or very low level; no clot in test tube).|For a period of 322 days (approximately one year) comprised of a screening visit (Visit 1), treatment period (Visits 2-15), unscheduled visit and end-of-trial visit (Visit 16).|Full analysis set - consisting of a total of 41 subjects who received at least one dose of trial product. For All Dosing Visits, the participants analyzed (N) are the 'All Visit Subjects Count' i.e. the sum of subject counts across all dosing visits combined.||percentage (%) of subjects|||Number
769454|NCT00713648|Primary|Rate (Number Per Subject Year) of Bleeding Episodes Requiring Treatment With a FXIII Containing Product During the Treatment Period|It represents the incidence of bleeding episodes requiring treatment with a FXIII-containing product.|For a period of 322 days (approximately one year) comprised of a screening visit (Visit 1), treatment period (Visits 2-15), unscheduled visit and end-of-trial visit (Visit 16).|Full analysis set - consisting of a total of 41 subjects who received at least one dose of trial product.||bleeding episodes per subject per year||Full Range|Mean
769455|NCT00713661|Secondary|The Secondary Endpoint is the Feasibility of the TachoSil® Application, Assessed by the Investigator.|Evaluation of feasibility was assessed by investigator after application of the TachoSil® sponge on the anastomosis. A feasible application implied that the entire TachoSil® adhered and covered at least 1cm beyond the margins of the anastomotic line and that if more than one sponge was used, they overlapped by at least 1 cm. The score was assisted by video recording.|Day of surgery|Data are presented for the 25 subjects treated with TachoSil®. They constitute the intention-to-treat (ITT) and the safety analysis set.||participants|||Number
769456|NCT00713661|Primary|The Primary Endpoint is the Feasibility of the TachoSil® Application, Reported by the Combined Assessment of the Investigator and External Assessor|Evaluation of feasibility was assessed by investigator after application of the TachoSil® sponge on the anastomosis. A feasible application implied that the entire TachoSil® adhered and covered at least 1cm beyond the margins of the anastomotic line and that if more than one sponge was used, they overlapped by at least 1 cm. The score was assisted by video recording. To ensure an independent assessment, the recording was assessed by an external, blinded assessor. In case of discrepancies between the assessment of the investigator and the assessor, the application was regarded as not feasible.|Day of surgery|"ITT + Safety Analysis Set.
All applications recorded as “not feasible” by external assessor was because he was not able to see it all the way around the anastomosis. The implication is that the primary endpoint was not really reporting the true feasibility, as it was hindered due to technical/practical problems recording the whole anastomosis."||participants|||Number
769457|NCT00713700|Primary|The Primary Effectiveness Endpoint is the Rate of Complete Closure of the Ductus Arteriosus at the Six-month Follow-up.|The primary efficacy endpoint is the rate of complete closure of the ductus arteriosus as assessed by the absence of residual flow and continuous murmur at the six-month follow-up by transthoracic echocardiography and physical exam respectively.|180 days|Of the 192 enrolled, 178 subjects experienced successful device placement.Of the 178 subjects with the device implanted,166 had a 6-month TTE and physical examination before 200 days post procedure or had an explant before the 6-month follow-up interval ended.||percentage of participants||95% Confidence Interval|Number
769459|NCT00713817|Secondary|Incidence of Adverse Events as a Measure of Subject Safety|The number of subjects who experienced an adverse event during the course of the study is presented.|Day 0 -35|The safety analysis set comprised all subjects who received at least one dose of study medication.||participants|||Number
769491|NCT00714233|Secondary|Change in Free Androgen Index (FAI)|Secondary measures of reduction in androgen measures of the different treatment arms. This is a ratio of total testosterone to sex hormone binding globulin (SHBG). The lower values correlate with lower amount of free testosterone. FAI <4 is consistent with a normal range.|baseline and 24 weeks|analysis per protocol||total T/SHBG||Standard Deviation|Mean
769460|NCT00713817|Secondary|Subject Global Impression of Change at the End of Treatment|A 7-point Likert-type scale was used, with the question: ‘Please assess the status of your nerve pain since entry into the study using the scale below’ with the markers “very much improved, much improved, slightly improved, no change, slightly worse, much worse or very much worse”. The number of subjects wo reported an improvement is presented.|Day 7 to 35|The efficacy analyses were conducted on data from all subjects who were randomised, received at least one dose of study medication and yielded on-treatment efficacy data.||participants|||Number
769461|NCT00713817|Secondary|Change From Baseline in Sleep Disruption 0-10 Numerical Rating Scale Score at the End of Treatment (Average of Last 7 Days Treatment)|"The sleep disruption Numerical Rating Scale was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate how your pain disrupted your sleep last night? where 0 = did not disrupt sleep and 10 = completely disrupted (unable to sleep at all). A negative value indicates an improvement in sleep disruption score from baseline."|Day 0-35|The efficacy analyses were conducted on data from all subjects who were randomised, received at least one dose of study medication and yielded on-treatment efficacy data.||units on a scale||Standard Deviation|Mean
769462|NCT00713817|Secondary|Number of Subjects With More Than a 20% Loss of Response at the End of Treatment|The percentage change from baseline in mean 0-10 Numerical Rating Scale pain score was calculated. The percentage changes from baseline were classified and the number of subjects with 20% or greater loss of response to treatment (i.e. percent increase from baseline ≥ 20%) is presented.|Day 0-35|The efficacy analyses were conducted on data from all subjects who were randomised, received at least one dose of study medication and yielded on-treatment efficacy data.||participants|||Number
769463|NCT00713817|Secondary|Number of Subjects Who Failed Treatment at the End of the Treatment Period|"Treatment failure was defined as follows:
A. Premature termination of Part B (Randomised-Withdrawal) study medication. All subjects who did not complete at least 28 days on Part B (Randomised-Withdrawal) study medicationOr:
B. An increase in pain, i.e. the mean pain 0-10 Numerical Rating Scale over seven consecutive days after Part B (Randomised-Withdrawal) randomisation had increased by at least 20% from the Part B (Randomised-Withdrawal) randomised treatment baseline."|Day 7 to time of last dose|The efficacy analyses were conducted on data from all subjects who were randomised, received at least one dose of study medication and yielded on-treatment efficacy data.||participants|||Number
769464|NCT00713817|Secondary|Change From Baseline Neuropathic Pain Score at the End of Treatment|The Neuropathic Pain Scale score is the 0-100 sum of 10 individual pain scores (0-10 Numerical Rating Scale, 0= no pain to 10 = most pain imaginable). A negative change from baseline indicates an improvement in pain.|Day 7 to 35|The efficacy analyses were conducted on data from all subjects who were randomised, received at least one dose of study medication and yielded on-treatment efficacy data.||units on a scale||Standard Deviation|Mean
769465|NCT00713817|Primary|Change From Baseline in Mean Daily Pain Severity on a 0-10 Numerical Rating Scale Score at the End of Treatment (Average of Last 7 Days Treatment)|"The pain severity Numerical Rating Scale was complete at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate the number that best describes your pain severity in the last 24 hours where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of neuropathic pain. A negative value indicates an improvement in pain score from baseline."|Day 0-35|The efficacy analyses were conducted on data from all subjects who were randomised, received at least one dose of study medication and yielded on-treatment efficacy data.||units on a scale||Standard Deviation|Mean
769466|NCT00713830|Other Pre-specified|Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia|Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the patient required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.|First dose of study drug up to 3 days after the last dose administration, for up to 120 weeks|Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.The one patient in the placebo group who received Lixisenatide was analyzed in the Lixisenatide group||participants|||Number
769467|NCT00713830|Secondary|Percentage of Patients Requiring Rescue Therapy During Main 24-Week Period|Routine fasting self-monitored plasma glucose (SMPG) and central laboratory FPG (and HbA1c after week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after week 12) were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG >270 milligram/deciliter (mg/dL) (15.0 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 24: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >8.5%. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline up to Week 24|mITT population.||percentage of participants|||Number
769468|NCT00713830|Other Pre-specified|Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.||percentage of participants|||Number
769487|NCT00714168|Primary|Weight Loss|Change in Weight from Baseline|Measured at Month 18|We used an intention-to-treat analysis with all randomized subjects included in the analysis.||kg||95% Confidence Interval|Least Squares Mean
769488|NCT00714233|Secondary|Change in Fasting Glucose|Change in fasting glucose concentration by treatment group pre to post intervention|baseline and 24 weeks|||mg/dL||Standard Deviation|Mean
769469|NCT00713830|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.||percentage of participants|||Number
769470|NCT00713830|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.||percentage of participants|||Number
769471|NCT00713830|Secondary|Change From Baseline in Fasting C-peptide and 2-hour Postprandial C-peptide at Week 24|The fasting C-peptide and the 2-hour postprandial C-peptide blood samples were drawn during a standardized meal challenge test (performed in selected sites). Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy.For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|Subgroup for standardized meal test in mITT population. Missing data was imputed using LOCF. here. number of patients analyzed = patients with baseline and at least 1 post-baseline C-peptide assessment during on-treatment period and 'n' = patients with baseline and at least 1 post-baseline assessment for the specified category.||nmol/L||Standard Error|Least Squares Mean
769472|NCT00713830|Other Pre-specified|Change From Baseline in Fasting Proinsulin-to-insulin Ratio and 2-hour Postprandial Proinsulin-to-insulin Ratio at Week 24|The fasting proinsulin-to-insulin ratio and 2-hour postprandial proinsulin-to-insulin ratio were measured during a standardized meal challenge test (performed in selected sites). Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|Subgroup for standardized meal test in mITT population. Missing data imputed using LOCF. Number of patients analyzed=patients with baseline and at least 1 post-baseline proinsulin-to-insulin ratio assessment during on-treatment period and 'n'= patients with baseline and at least 1 post-baseline assessment for the specific category.||ratio||Standard Error|Least Squares Mean
769473|NCT00713830|Secondary|Change From Baseline in Fasting Proinsulin and 2-hour Postprandial Proinsulin at Week 24|The fasting Proinsulin and the 2-hour postprandial Proinsulin blood samples were drawn during a standardized meal challenge test (performed in selected sites). Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|Subgroup for standardized meal test in mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline proinsulin assessment during on-treatment period and 'n' = patients with baseline and at least 1 post-baseline assessment for the specified category.||pmol/L||Standard Error|Least Squares Mean
769474|NCT00713830|Secondary|Change From Baseline in Fasting Plasma Insulin (FPI) and 2-hour Postprandial Plasma Insulin at Week 24|The fasting plasma insulin and the 2-hour postprandial plasma insulin blood samples were drawn during a standardized meal challenge test (performed in selected sites). Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|Subgroup for standardized meal test in mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline plasma insulin assessment during on-treatment period and 'n' = patients with baseline and at least 1 post-baseline assessment for the specified category.||pmol/L||Standard Error|Least Squares Mean
769475|NCT00713830|Secondary|Change From Baseline in Fasting Glucagon and 2-hour Postprandial Glucagon at Week 24|The fasting glucagon and the 2-hour postprandial glucagon blood samples were drawn during a standardized meal challenge test (performed in selected sites). Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|Subgroup for standardized meal test in mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline glucagon assessment during on-treatment period and 'n' = patients with baseline and at least 1 post-baseline assessment for the specified category.||ng/L||Standard Error|Least Squares Mean
769489|NCT00714233|Secondary|Triglyceride Concentration by Treatment Group|Change in triglyceride measures pre and post intervention as representative of lipid changes by treatment group; metformin, lifestyle intervention, oral contraceptive or placebo|baseline and 24 weeks|||mg/dL||Standard Deviation|Mean
769490|NCT00714233|Secondary|Change in SHBG|Measurement of SHBG by treatment group pre and post intervention|baseline and 24 weeks|||ratio||Standard Deviation|Mean
769476|NCT00713830|Other Pre-specified|Change From Baseline in Glucose Excursion at Week 24|Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the standardized meal test (performed in selected sites), before study drug administration. Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|Subgroup for standardized meal test in mITT population. Missing data was imputed using last observation carried forward (LOCF). Here, number of patients analyzed = patients with baseline and at least 1 post-baseline glucose excursion assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
769477|NCT00713830|Secondary|Change From Baseline in Beta-cell Function Assessed by HOMA-beta at Week 24|Beta cell function was assessed by HOMA-beta. HOMA-beta blood samples were drawn during a standardized meal challenge test (performed in selected sites). HOMA-beta (% of normal beta cells function) = (20 multiplied by fasting plasma insulin [micro unit per milliliter]) divided by (FPG [mmol/L] minus 3.5). Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|Subgroup for standardized meal test in mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HOMA-beta assessment during on-treatment period.||% of normal beta cells function||Standard Error|Least Squares Mean
769478|NCT00713830|Secondary|Change From Baseline in Body Weight at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.||kilogram||Standard Error|Least Squares Mean
769479|NCT00713830|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline FPG assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
769480|NCT00713830|Secondary|Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Week 24|The 2-hour PPG blood sample was drawn 2 hours after start of a standardized meal (standardized meal challenge test performed in selected sites). Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|Subgroup for standardized meal test in mITT population. Missing data was imputed using last observation carried forward (LOCF). Here, number of patients analyzed = patients with baseline and at least 1 post-baseline 2-hour PPG assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
769481|NCT00713830|Primary|Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|Absolute change = HbA1c value at Week 24 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in Modified Intent-to-Treat (mITT) population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population:all randomized patients who received at least 1 dose;had baseline,at least 1 post-baseline efficacy assessment, irrespective of compliance with study protocol/procedures. Last observation carried forward used. Number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.||percentage of hemoglobin||Standard Error|Least Squares Mean
769482|NCT00714051|Primary|Number of Participants Who Fell on a Tripping Test|Participants completed a tripping test upon completion of the 4 weeks training period. Participants walked along a platform while harnessed to an overhead rail. Participants walked at a self-selected pace knowing that they will be tripped but do not know how or when the trip will be induced. The trip is induced by an obstruction that deploys from the floor. A decoy rope was laid across the pathway about 3 meters before the trip to intentionally mislead the participant to expect the trip at that point. This expectation affects gait and response to a trip. The participant was tripped on the 3rd set of 10 walking trials.|4 weeks|||participants|||Number
769483|NCT00714168|Secondary|Body Composition|Change in Percent Body Fat from Baseline|Measured at Month 18|Intention-to-treat with all randomized subjects included in the analysis||percent body fat||95% Confidence Interval|Least Squares Mean
769484|NCT00714168|Secondary|Cardiovascular Fitness|Change in Minutes to achieve 85% of age-predicted maximal heart rate from Baseline|Measured at Month 18|Intention-to-treat with all randomized subjects included in the analysis.||minutes||95% Confidence Interval|Least Squares Mean
769485|NCT00714168|Secondary|Energy Intake|Change in Energy Intake from Baseline|Measured at Month 18|Intention-to-treat with all randomized subjects analyzed.||kcal/day||95% Confidence Interval|Least Squares Mean
769486|NCT00714168|Secondary|Physical Activity|Change in Physical Activity from Baseline|Measured at Month 18|Intention-to-treat with all randomized subjects included in the analysis.||kcal/week||95% Confidence Interval|Least Squares Mean
769493|NCT00714233|Primary|Measure Number of Adolescent Girls With PCOS Who Can be Successfully Recruited Into a Randomized Clinical Trial That Includes Lifestyle Modification|The measure is to determine a number of successfully recruited overweight or obese adolescents to a randomized trial of lifestyle therapy in the community of Rochester, NY|24 week|Analysis was a description of number of recruited subjects.||participants|||Number
769494|NCT00714259|Primary|Progression Free Survival Post Transplant|Subjects surviving without disease progression 2 years after transplant as evidenced by no new disease showing on radiologic scans and / or bone marrow pathology.|2 years post transplant|||participants|||Number
769495|NCT00714259|Primary|Progressive Free Survival Post Transplant|Subjects surviving without disease progression 365 days after transplant as evidenced by decreased disease and no new disease showing on radiologic scans and / or bone marrow pathology.|365 days post transplant|||participants|||Number
769496|NCT00714259|Primary|Progressive Free Survival Post Transplant|Subjects surviving without disease progression 180 days after transplant as evidenced by decreased disease and no new disease showing on radiologic scans and / or bone marrow pathology.|180 days post transplant|||participants|||Number
769497|NCT00714259|Secondary|Composite Incidence of Acute and Chronic Graft Versus Host Disease||Up to 100 days post transplant.|||participants|||Number
769498|NCT00714259|Secondary|Number of Participants With Detectable Donor Chimerism at up to 100 Days Post Transplant|Measured by number of participants that have chimerism study results that show the number of donor cells and the number of recipient cells present in the blood after post-transplant lymphocyte infusions continue to be predominately either donor or recipient.|Post transplant up to 100 days post transplant|||participant|||Number
769499|NCT00714259|Secondary|Non-relapse Treatment Related Mortality|Death related to treatment without relapse within 100 days after transplant|Within 100 days post transplant|||participants|||Number
769500|NCT00714259|Primary|Progressive Free Survival Post Transplant|subjects surviving without disease progression at 100 days after transplant as evidenced by decreased disease and no new disease showing on radiologic scans and / or bone marrow pathology.|100 days post transplant|||participants|||Number
769501|NCT00714285|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|During the entire study period (Days 0-180)|Analysis was performed on the Total Vaccinated cohort which included all subjects with a documented vaccine administration.||Subjects|||Number
769502|NCT00714285|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AE(s).|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination|During a 21 day (Days 0-20) follow-up period after vaccination-|Analysis was performed on the Total Vaccinated cohort which included all subjects with a documented vaccine administration.||Subjects|||Number
769503|NCT00714285|Secondary|Number of Subjects Reporting Any Medically Significant Conditions (MSCs) and Auto-immune Diseases (AIDs).|MSCs were defined as those adverse events (AEs) prompting emergency room visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. AIDs include a large group of diseases characterized by abnormal functioning of the immune system that causes immune system to produce antibodies against own tissues.|During the entire study period (Days 0-180)|Analysis was performed on the Total Vaccinated cohort which included all subjects with a documented vaccine administration.||Subjects|||Number
769504|NCT00714285|Secondary|Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading.|Solicited general symptoms assessed by the former GSK rules of grading were arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any = occurrence of any specified solicited general symptoms reported irrespective of intensity grade or relationship to vaccination. Any fever = oral temperature ≥ 37.5 °C. Grade 3 symptoms = symptoms that prevented normal activities. Grade 3 fever = oral temperature above 39.0°C. . Related = symptoms considered by the investigator to have a causal relationship to vaccination.|During a 7-day follow-up period (Days 0-6) after vaccination|Analysis was performed on theTotal Vaccinated cohort which included all subjects with a documented vaccine administration and symptom sheet completed||Subjects|||Number
769505|NCT00714285|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed were arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any =occurrence of any specified solicited general symptoms reported irrespective of intensity grade or relationship to vaccination. Any fever = oral temperature ≥ 38.0 degrees Celsius (°C).. Grade 3 symptoms = symptoms that prevented normal activities. Grade 3 fever = oral temperature ≥39.0°C. Related = symptoms considered by the investigator to have a causal relationship to vaccination|During a 7-day follow-up period (Days 0-6) after vaccination|Analysis was performed on theTotal Vaccinated cohort which included all subjects with a documented vaccine administration and symptom sheet completed||Subjects|||Number
769506|NCT00714285|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms Reported by the Former GSK Rules of Grading.|Solicited local symptoms assessed by the former GSK rules of grading were pain, redness and swelling. Any was defined as occurrence of any specified solicited local symptoms reported irrespective of intensity grade. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeters (mm).|During a 7-day follow-up period (Days 0-6) after vaccination|Analysis was performed on the Total Vaccinated cohort which included all subjects with a documented vaccine administration and symptom sheet completed.||Subjects|||Number
769589|NCT00706004|Secondary|Self Reported Adverse Effects at Each Study Visit|Adverse effects are problems reported by each study subject that they experienced during this clinical trial. Examples are headache and nausea. Study subjects were asked at each visit while on study drug to report any adverse affects that had occurred since the last visit.|During entire study period|Participants who completed the study||participants|||Number
769507|NCT00714285|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any specified solicited local symptoms reported irrespective of intensity grade. Grade 3 pain was defined as considerable pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 100 millimeters (mm).|During a 7 day (Days 0-6) follow-up period after vaccination|Analysis was performed on theTotal Vaccinated cohort which included all subjects with a documented vaccine administration and symptom sheet completed.||Subjects|||Number
769508|NCT00714285|Secondary|Number of Subjects Seroprotected for HI Antibodies Against the Vaccine Influenza Strains.|A seroprotected subject was defined as a subject with a serum HI titer ≥1:40 that usually is accepted as indicating protection. The Influenza vaccine strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and B/Jiangsu antigens.|At Days 0 and 21|Analysis was performed on According To Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
769509|NCT00714285|Secondary|HI Antibody Seroconversion Factors Against the Vaccine Influenza Strains|Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The Influenza vaccine strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and B/Jiangsu antigens.|Day 21|Analysis was performed on According To Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Fold increase||95% Confidence Interval|Geometric Mean
769510|NCT00714285|Secondary|Number of Subjects Seroconverted for HI Antibodies Against the Vaccine Influenza Strains.|A seroconverted subject was defined as a subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer. The vaccine influenza strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and B/Jiangsu antigens.|At Day 21|Analysis was performed on According To Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
769511|NCT00714285|Primary|Serum Haemagglutination-inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains.|Antibody titers were expressed as Geometric mean titers (GMTs).The vaccine influenza strains included A/Solomon Islands,A/Wisconsin,B/Malaysia and B/Jiangsu antigens.|At Day 0 and Day 21|Analysis was performed on According To Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Titer||95% Confidence Interval|Geometric Mean
769512|NCT00714311|Secondary|Borderline Symptomatology (DSM-IV Criteria)||1 month||||||
769513|NCT00714311|Secondary|Attachment Style and Reflective Function (Adult Attachment Interview, AAI)||1 year||||||
769514|NCT00714311|Secondary|Self-assessment of Psychopathology (BDI, STAI, BSI)||1 year||||||
769515|NCT00714311|Secondary|Number of Self-harming Acts||1 year||||||
769516|NCT00714311|Secondary|Level of Personality Organization (Structured Interview for Personality Organization, STIPO)||1 year||||||
769517|NCT00714311|Secondary|Psychosocial Functioning (Global Assessment of Functioning, GAF-Score)||1 year||||||
769518|NCT00714311|Primary|Suicidality (Suicide Attempts)||1 year||||||
769519|NCT00714311|Primary|Drop-out|Did not finish one year of treatment.|1 year|||participants|||Number
769520|NCT00714389|Primary|Maximal Flow Rate|Maximal uroflow of spontaneous subject voids|March 2008|||mL/sec||Standard Deviation|Mean
769521|NCT00714389|Primary|Voided Volume|Volume of spontaneous void|March 2008|||mL||Standard Deviation|Mean
769522|NCT00714493|Secondary|Percent of Patients Who Achieved ACR20 at Weeks 26.|Percent of patients who achieved ACR20 at Weeks 26. A patient is considered achieving ACR20 if the following two conditions are met: 1) An improvement of ≥ 20% from baseline in both the swollen joint count (66 joints) and tender joint count (68 joints; 2) An improvement of ≥ 20% from baseline in at least 3 of the following 5 assessments:Patient’s assessment of pain visual analog scale (VAS), Patient’s global assessment of disease activity (VAS), Evaluator’s global assessment of disease activity (VAS), Patient’s assessment of physical function as measured by the HAQ disability index, and CRP.|Week 26|||percentage|||Number
769523|NCT00714493|Secondary|Percent of Patients Who Achieved ACR20 at Week 10|Percent of patients who achieved ACR20 at Week 10. A patient is considered achieving ACR20 if the following two conditions are met: 1) An improvement of ≥ 20% from baseline in both the swollen joint count (66 joints) and tender joint count (68 joints; 2) An improvement of ≥ 20% from baseline in at least 3 of the following 5 assessments:Patient’s assessment of pain visual analog scale (VAS), Patient’s global assessment of disease activity (VAS), Evaluator’s global assessment of disease activity (VAS), Patient’s assessment of physical function as measured by the HAQ disability index, and CRP.|Week 10|||percentage|||Number
769524|NCT00714493|Secondary|Change From Baseline in Physical Function (HAQ)|Change from baseline in physical function (HAQ) at Week 26. HAQ assesses the degree of difficulty a person has in accomplishing tasks. A lower HAQ score indicates less difficulty. Change from baseline is computed as Week 26 value minus baseline value. A negative value in change from baseline indicates an improvement.|Week 26|||scale -3 to 3||Standard Deviation|Mean
769525|NCT00714493|Secondary|Change From Baseline in Physical Function (HAQ)|Change from baseline in physical function (HAQ) at Week 10. HAQ assesses the degree of difficulty a person has in accomplishing tasks. A lower HAQ score indicates less difficulty. Change from baseline is computed as Week 10 value minus baseline value. A negative value in change from baseline indicates an improvement.|Week 10|||scale -3 to 3||Standard Deviation|Mean
769526|NCT00714493|Secondary|Percent of Patients Who Achieved EULAR Response at Week 26, Regardless of EULAR Response Status at Weeks 10, 14, and 22, With or Without Dose Increase Prior to Week 26|Percent of patients who achieved EULAR response at Week 26, regardless of EULAR response status at Weeks 10, 14, and 22, with or without dose increase prior to Week 26|Week 26|||percentage|||Number
769528|NCT00714493|Primary|Percent of Patients Who Achieved a EULAR (The European League Against Rheumatism) Response at Week 10|Percent of patients who achieved EULAR response at Week 10. EULAR response is defined based on the DAS28 score and the EULAR response criteria (Van Gestel et al, 1996 and 1999). At a given visit, patients with a DAS28 score of ≤ 5.1 are considered EULAR responders if the improvement from baseline in their DAS28 score is greater than 0.6; Or patients with a DAS28 score > 5.1 are considered EULAR responders if the improvement from baseline in their DAS28 score is > 1.2.|Week 10|The evaluable population was the subset of the mITT population (included the enrolled patients who received at least 1 dose of study medication) after excluding all 6 patients from Site 8631 where significant trial misconducts were identified.||Percentage|||Number
769529|NCT00714571|Primary|Memory Test Accuracy on Trained Stimuli|Accuracy (Percent correct) for trained stimuli. Stage 1: Object location association test Stage 2: Face name association test|Pre-training, post-training, 1 month|MST older adults Stage 1: 1 participant excluded due to undisclosed ongoing chemotherapy treatment XP older adults Stage 1: 1 participant decided not to participate after randomization MST MCI Stage 1: 1 participant diagnosed with Alzheimer's dementia within 1 month of completing study||Percent correct||Standard Deviation|Mean
769530|NCT00714688|Secondary|Change in Conners Adult ADHD Rating Scale Self Report Short Version (CAARS-S:S) Total Score|The CAARS-S:S is a 26-item self-report scale that measures symptoms based on the DSM-IV criteria for ADHD. Respondents were asked to rate items pertaining to their behavior/problems using the following 4-point scale (from 0 = Not at all, never; to 3 = Very much, very frequently). The CAARS-S:S total score range is from 0 (best) to 78 (worse). The change in CAARS-S:S was assessed from baseline to end of treatment (week 13 or or last post-baseline assessment)|from baseline to 13 weeks|The ITT analysis set (includes all randomized subjects) was considered the primary efficacy analysis set. It excludes patients for which a baseline value was missing.||units on a scale||Standard Deviation|Mean
769531|NCT00714688|Secondary|Clinical Global Impression-Change (CGI-C)|The CGI-C rating scale is used to rate the change in severity of the subject's illness compared to baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).|13 weeks|The ITT analysis set (includes all randomized subjects) was considered the primary efficacy analysis set.It excludes patients for which either a baseline or end of treatment value was missing.||units on a scale||Full Range|Median
769532|NCT00714688|Secondary|Change in Clinical Global Impression-Severity (CGI-S) From Baseline to End of Treatment|The CGI-S rating scale is used to rate the severity of a subject's illness on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe illness). The change in CGI-S was assessed from baseline to end of treatment (week 13 or or last post-baseline assessment)|from baseline to13 weeks|The ITT analysis set (includes all randomized subjects) was considered the primary efficacy analysis set.||units on a scale||Full Range|Median
769533|NCT00714688|Primary|Attention Deficit/Hyperactivity Disorder (ADHD) Symptoms Total Score of the Conners Adult ADHD Rating Scale (CAARS)|The primary endpoint was the change in the ADHD symptoms total score of the investigator-rated CAARS from baseline to the last assessment in the double-blind treatment period. CAARS assesses ADHD symptoms and behaviors in adults using a scale ranging from 0 (best) to 54 (worst). For subjects without a post-baseline efficacy measurement, a change of 0 units was imputed.|from baseline to 13 weeks|The ITT analysis set (includes all randomized subjects) was considered the primary efficacy analysis set.||units on a scale||Standard Deviation|Mean
769534|NCT00714714|Primary|Assessment of Facial Irritation and Cutaneous Effects|Cumulative daily weekday scores for two weeks on Expert Grader Assessments: Dryness (0-8, none-deep)and Erythema (0-8, none-severe) and Self-Assessments: Burning/Stinging (0-3, none-severe) and Itching (0-3, none-severe)|cumulative daily weekday scores for two weeks|One panelist terminated treatment on Day 2. Her scores were carried over and the analysis was based on Intention to Treat (ITT).||Ordinal data treated as interval||Standard Deviation|Mean
769535|NCT00714792|Primary|Number of Subjects With Evidence of Bacteria in Urine Sample by Microbiologic Evaluation|Sterile specimens were obtained from subjects. The urethra was prepared with Betadine and an 8Fr urethral catheter passed into the bladder and urine obtained in a sterile container. Bladder washings were obtained after urine was completely emptied from the bladder via the catheter. Saline (60ccs) was used to vigorously irrigate the bladder 2-3 times through the 8 Fr catheter. The bladder washings were then collected and placed in a sterile container. The experimental cultures included 100ml inoculated on Blood Agar, MacConkey Agar and Brucella Blood Agar, incubated for 72 hours at 35-37 C in ambient atmosphere supplemented with 5-8% carbon dioxide. Colonies were counted to quantify the cfu/ml and all growth of any organism was reported. Organisms were then identified using standard microbiologic techniques.|within one week of enrollment|One overactive bladder subject had greater than 100,000 cfu in routine culture and their specimens were excluded from the analysis.||participants|||Number
769536|NCT00714870|Primary|Change in Child Self-report Health Related Quality of Life Scores After Intervention: Total, Physical and Psychosocial (Presented in This Order)|"Using a validated quality of life questionnaire we analyzed change in child self-report scores comparing baseline questionnaire scores to end of study questionnaire scores for these categories: total (includes physical and psychosocial), physical, and psychosocial(includes emotional, social, and school).
Scale information: The range is 0-100 in terms of points they could get for each category. They had the options of 0-4, 0 being the best. 0 would then be transformed to a score of 100, 1 to 75, 2 to 50, 3 to 25 and 4 to 0.
Results are clinically significant if the difference in scores are higher than the Minimal Clinical Important Difference (MCID). MCID are as follows: Total Score: 4.36, Physical Health: 6.66, Psychosocial Health: 5.30."|one year comparing change in questionnaire scores at baseline to results from questionnaire completed a year later|To detect an effect with greater than or equal to 80% power at a 0.05 two sided significant level, we concluded we needed 22 participants completing each group, intervention and control||units on a scale||Standard Deviation|Mean
769537|NCT00714948|Primary|To Determine the Progression Free Survival Rate at One Year Untreated Patients With Advanced/Metastatic Urothelial Carcinoma Treated With the Combination of Sorafenib, Gemcitabine, and Cisplatin.||conclusion of the study||||||
769538|NCT00715026|Secondary|Continued Assessment of Implant Survivorship and Incidences of Adverse Events.|A total of 37 Adverse Events were reported. There have been no UADEs reported in this study population. At the time of site closure all AEs were resolved or tolerated. Implant survivorship not reportable due to early study termination.|At all follow-up visits through 5 Years and postcard follow-up 6 - 10 Years|||adverse events|||Number
769539|NCT00715026|Primary|Harris Hip Score|The Harris Hip Score was developed to assess hip disabilities and methods of treatment and has been in use for decades. It evaluates patients on the basis of pain, function, absence of deformity and range of motion. The Harris Hip Score could range from 0 to 100. Scores less then 70 are poor, scores 70 to 79 are fair, scores 80 to 89 are good, and scores 90 to 100 are excellent.|Pre-op, 3 Month Post-Op and Annual Post-Op visits through 5 Years|Data was received on 24 subjects/25 hips at preop, on 17 subjects/18 hips at 3 months, and on 4 subjects at 1 year prior to the early termination of the study. Each hip, whether unilateral or bilateral, was counted separately. Early study termination was done due to voluntary removal of the device from the US market.||units on a scale||Standard Deviation|Mean
769540|NCT00715078|Primary|Cumulative CD54 Upregulation Ratio Between Each of the Cohorts.|An analysis of variance model for the log transformed cumulative CD54 upregulation ratio (CD54 upregulation is the fold increase in the final product (FP) from buoyant density separations (BDS) step 65. BDS65 step refers to sample taken after both BDS77 and BDS65 but before ex vivo culture in the presence of antigen PA2024. FP refers to sample taken after ex vivo culture) that includes the antigen concentration cohort as the independent variable was performed. Subjects who received all 3 infusions were included.|Baseline, Months 2, 4 and 6.|Cumulative CD54 upregulation ratio will be the primary end point and calculated as the sum of Infusion 1 through Infusion 3 final product values for each infused subject.||Ratio ofCD54 molecules on BDS65:FP cells||Standard Error|Mean
769541|NCT00715104|Secondary|Comparison of Booster Effect in Antigen PAP-Specific T Cell Immunity Over Time Between the Two Randomized Groups|The number of Antigen PAP-specific T cells was enumerated by interferon gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) assays (memory T cells). The two groups were compared in the statistical model are: Randomized to Booster and Randomized to No Booster. PAP = Prostatic Acid Phosphatase.|12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RP|Subjects received at least 1 infusion of sipuleucel-T, were randomized to receive either a booster infusion or no further treatment following RP, and had blood samples suitable for ELISPOT analysis.||numbers of spots||Standard Error|Mean
769542|NCT00715104|Secondary|Comparison of Booster Effect in Antigen PA2024-Specific T Cell Immunity Over Time Between the Two Randomized Groups|The number of Antigen PA2024-specific T cells was enumerated by interferon gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) assays (memory T cells). The two groups were compared in the statistical model are: Randomized to Booster and Randomized to No Booster.|12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RP|Subjects received at least 1 infusion of sipuleucel-T, were randomized to receive either a booster infusion or no further treatment following RP, and had blood samples suitable for ELISPOT analysis.||number of spots||Standard Error|Mean
769543|NCT00715104|Secondary|Effect of a Post-RP Booster Infusion of Sipuleucel-T Over Time of Antigen PAP-Specific T Cell Immunity in the Peripheral Blood.|The number of PAP-specific T cells was enumerated by interferon gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) assays (memory T cells). PAP = Prostatic Acid Phosphatase.|12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RP|Subjects received at least 1 infusion of sipuleucel-T, were randomized to receive a booster, and had blood samples suitable for ELISPOT analysis.||number of spots||Standard Error|Mean
769544|NCT00715104|Secondary|Effect of a Post-RP Booster Infusion of Sipuleucel-T Over Time of Antigen PA2024-Specific T Cell Immunity in the Peripheral Blood.|The number of PA2024-specific T cells was enumerated by interferon gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) assays (memory T cells).|12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RP|Subjects received at least 1 infusion of sipuleucel-T, were randomized to receive a booster, and had blood samples suitable for ELISPOT analysis.||numbers of spots||Standard Error|Mean
769545|NCT00715104|Secondary|Change in Antigen PAP-specific T Cell Immunity in Peripheral Blood|Antigen PAP-specific T cell immune response is measured using interferon gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) assays. PAP = Prostatic Acid Phosphatase.|Baseline (screening visit) and up to 12-weeks post-RP visit (24 months post sipuleucel-T)|"All subjects who received at least 1 infusion of sipuleucel-T and underwent subsequent RP.
Results are not presented by arm because all assessments were performed prior to randomization to booster."||numbers of spots||Standard Error|Mean
769546|NCT00715104|Secondary|Change in Antigen PA2024-specific T Cell Immunity in Peripheral Blood|"Antigen PA2024-specific T cell immune response is measured using interferon gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) assays.
This analysis was performed as previously described in Fong L et al. (J Immunol. 2001;167(12):7150–7156.). The unit of analysis is the number of IFN-γ ELISPOT counts per 300,000 peripheral blood mononuclear cells."|Baseline (screening visit) and up to 12-weeks post-RP visit (24 weeks following sipuleucel-T)|"All subjects who received at least 1 infusion of sipuleucel-T and underwent subsequent RP.
Results are not presented by arm because all assessments were performed prior to randomization to booster."||numbers of spots||Standard Error|Mean
769547|NCT00715104|Secondary|Change in the Number of Infiltrating CD8+ T Cells Within the Prostate Tissue Between the Biopsy and the Post-RP Tissue Specimens in Each Subject|CD8+ T cell infiltration within prostate tissue was quantified using immunohistochemistry (IHC) staining techniques. Cells were enumerated per unit area (cells/μm2). For post-RP tissue specimens, three areas of interest were identified: Benign tissue, tumor tissue, and tumor interface tissue.|Pre-treatment biopsy (baseline) and post-RP (12 weeks following sipuleucel-T)|"All subjects who received at least 1 infusion of sipuleucel-T and underwent subsequent RP.
Results are not presented by arm because all assessments were performed prior to randomization to booster"||cells/μm2||Standard Error|Mean
769548|NCT00715104|Secondary|Change in the Number of Infiltrating CD4+ T Cells Within the Prostate Tissue Between the Biopsy and the Post-RP Tissue Specimens in Each Subject|CD4+ T cell infiltration within prostate tissue was quantified using immunohistochemistry (IHC) staining techniques. Cells were enumerated per unit area (cells/μm2). For post-RP tissue specimens, three areas of interest were identified: Benign tissue, tumor tissue, and tumor interface tissue.|Pre-treatment biopsy (baseline) and post-RP (12 weeks post-treatment)|"All subjects who received at least 1 infusion of sipuleucel-T and underwent subsequent RP.
Results are not presented by arm because all assessments were performed prior to randomization to booster"||cells/μm2||Standard Error|Mean
769590|NCT00706004|Secondary|Body Mass Index||baseline, 2 weeks of treatment, 4 weeks of treatment|Participants who completed the study||kg/m^2||Standard Deviation|Mean
769613|NCT00706329|Primary|Close Belly Button or Umbilical Hernia|The study was terminated prematurely by the IRB. Results are not shared due to data integrity concerns. These concerns are outlined in an FDA warning letter.|After surgery, subjects will be followed at intervals of one month and six months from date of surgery.||||||
769549|NCT00715104|Primary|Change in the Number of Infiltrating CD3+ T Cells Within the Prostate Tissue Between the Biopsy and the Post-RP Tissue Specimens in Each Subject|CD3+ T cell infiltration within prostate tissue was quantified using immunohistochemistry (IHC) staining techniques. Cells were enumerated per unit area (cells/μm2). For post-RP tissue specimens, three areas of interest were identified: Benign tissue, tumor tissue, and tumor interface tissue.|Pre-treatment biopsy (baseline) and post-RP (12 weeks post-treatment)|"All subjects who received at least 1 infusion of sipuleucel-T and underwent subsequent RP.
Results are not presented by arm because all assessments were performed prior to randomization to booster."||cells/μm2||Standard Error|Mean
769550|NCT00715117|Primary|Number of Patients Reporting Side Effects|Using adverse events and laboratory values Safety & toxicity were evaluated between those on placebo for 8 weeks and those on naltrexone for either 8 or 16 weeks.|8 weeks or 16 weeks|The Fisher Exact Test was used to evaluate the number of side effects reported between placebo and naltrexone groups. The Student T-test was used to evaluate the differences between the mena values of laboratory tests.||participants|||Number
769551|NCT00715117|Secondary|Change in Quality of Life Scores From Baseline to After 8 Weeks of Naltrexone Therapy|IMPACT III was a pediatric Crohn's specific quality of life survey used in this study. It examines five major categories influencing the quality of life in children with Crohn’s disease including bowel symptoms, systemic symptoms, emotional well-being, social well-being, and body image perception. The IMPACT-III uses 5-point Likert scale ranging from 1 to 5 for all answers. The outcome score ranges from 35 to 175, with higher scores suggesting better quality of life. So an increase in score denotes improved Quality of life.|16 weeks|||units on a scale||Standard Error|Mean
769552|NCT00715117|Secondary|Pediatric Crohn's Disease Activity Index Score (PCDAI)|"Secondary outcome was efficacy on clinical activity. Mean pretreatment PCDAI scores in patients had moderate to severe disease activity at baseline were compared between those who received placebo for 8 weeks and those who received active experimental drug, naltrexone.
The PCDAI score is a number unit that is calculated from symptoms scores by the subject over a 7-day period prior to the visit, laboratory values, height & weight, and physical exam findings. A score of 10 and under denotes remission. Mild disease (score of 11-30); moderate disease (score of 31-45), a severe disease (scores greater than 45. A decline of 10 points or more is considered response to therapy. The score can range from 0 to >60 Patient must have a PCDAI score of equal or greater than 30 to qualify for this study (i.e., moderate to severe disease)."|Pretreatment and 8 weeks|The power calculations were performed using STPLAN version 4.1. The current investigation was designed as a pseudo-cross over study to increase the number of participants. In the proposed study, it was assumed that 80% would respond to naltrexone and that no more than 25% of the placebo.||units on a scale||Standard Error|Mean
769591|NCT00706004|Secondary|Bristol Stool Scale Score|The Bristol Stool Scale is a scale used to rate the consistency of stool. Stool types are accompanied by a written description. There are seven types of stool that are scored from 1 to 7. A score of 1 or 2 indicates constipation; a score of 6 or 7, diarrhea.|2-week run-in period, 2 weeks of treatment, 4 weeks of treatment|Participants who completed the study||scores on a scale||Standard Deviation|Mean
769609|NCT00706134|Secondary|Percentage of Patients Achieving Systolic Blood Pressure Response|Patients achieving a systolic blood pressure response had to have a msSBP < 140 mmHg at the end of the study and/or a ≥ 20 mmHg reduction in msSBP from baseline to the end of the study.|Baseline to end of study (Week 8)|Full analysis set (FAS) - All randomized patients. Two randomized patients who did not meet study criteria were excluded from the FAS.||Percentage of participants|||Number
769563|NCT00705874|Secondary|Pharmacokinetics||End of Study||||||
769564|NCT00705874|Secondary|Drug Safety||Ongoing||||||
769565|NCT00705874|Primary|Maximum Tolerated Dose (MTD)|"The MTD was defined as the dose below which one-third of at least 6 patients (2/6) experienced a dose limiting toxicity (DLT).
DLTs had to occur during cycle 1 of treatment and had to be considered related to PG-11047:
Any nonhematologic toxicity > Grade 3 lasting > 3 days
Grade 4 thrombocytopenia
Grade 4 Anemia on the next scheduled dosing day
Grade 4 Neutropenia (lasting > than 5 days
Any febrile neutropenia (Grade 3 or 4))
Inability to receive all scheduled doses of PG-11047 during the first dosing cycle due to drug related toxicity"|End of Study|Cohorts comprised 3 patients. When a patient experienced a treatment related toxicity qualifying as a DLT, up to 3 additional patients were to be enrolled at that dose. Patients who completed cycle 1 per protocol were evaluable.||mg|||Number
769566|NCT00705939|Secondary|Platelet Count||Platelet count at Baseline and Months 12, 24 and 36|||Platelets per cubic millimeter||Standard Deviation|Mean
769567|NCT00705939|Secondary|Hemoglobin||Hemoglobin at Baseline and Months 12, 24 and 36|||mg/dL||Standard Deviation|Mean
769568|NCT00705939|Other Pre-specified|Liver Volume Multiples of Normal (MN)|Liver volume measured by MRI. Normal liver volume is 25 mL/kg × body weight (kg).|Baseline and Months 12, 24 and 36|Intent to treat. In the Switchover group, two patients did not have MRI.||Multiples of Normal Liver Volume||Standard Deviation|Mean
769569|NCT00705939|Other Pre-specified|Spleen Volume Multiples of Normal (MN)|Spleen volume measured by MRI. Normal spleen volume is 2 mL/kg × body weight (kg)|Baseline and Months 12, 24, and 36|Intent to treat. In the Switchover group, two patients did not have MRI and one patient was splenectomized.||Multiples of Normal Spleen Volume||Standard Deviation|Mean
769570|NCT00705939|Secondary|Liver Volume|Liver volume measured by MRI|Liver volume at Baseline and Months 12, 24 and 36|Intent to treat. In the Switchover group, two patients did not have MRI .||mL||Standard Deviation|Mean
769592|NCT00706004|Secondary|Patient Assessment of Constipation Symptoms|The Patient Assessment of Constipation – Symptom (PAC-SYM) survey is a 1-page 12-item tool that measures a patient’s assessment of constipation symptoms. The items are in Likert scale format and address the severity of stool, rectal and abdominal symptoms over the past 2 weeks. Items are scored on a scale of 0 to 4, with 4 indicating the most severe. To compute the overall score, the scores of the non-missing items are summed and this is divided by the total number of non-missing items (overall score range, 0 to 4).|2-week run-in period, 2 weeks of treatment, 4 weeks of treatment|Participants who completed the study||scores on a scale||Standard Deviation|Mean
769593|NCT00706004|Primary|Number of Spontaneous Bowel Movements Per Week||2-week run-in period, 2-weeks of treatment, 4-weeks of treatment|Participants who completed the study||bowel movements||Standard Deviation|Mean
769594|NCT00706095|Primary|Best Overall Response Per Response Evaluation Criteria in Solid Tumors (RECIST)|Defined as the best response from the start of treatment until disease progression or recurrence. Lesions measured by computed tomography (CT) scan and magnetic resonance imaging (MRI). Objective response rate: complete response (CR-disappearance of all lesions)+ partial response (PR-30% decrease in lesion diameter), Progressive Disease (PD-20% increase in lesion diameter), stable disease (SD-neither shrinkage nor increase of lesions).|throughout the study and up to 30 days after the last dose of study drug|ITT Population||Number of Participants|||Number
769595|NCT00706095|Primary|Mean (SD) Pharmacokinetic (PK) Parameter Maximum Observed Plasma Concentration (Cmax)||Pre-dose (-0.5h); post-dose at 15 min, 30 min, 60 min, 2 hrs, 4 hrs, 6 hrs, 10 hrs, 24 hrs, 48 hrs, 72hrs, 96 hrs, 120 hrs and 144 hours.|Pharmacokinetic Population||ng/mL||Standard Deviation|Mean
769596|NCT00706095|Primary|Mean (SD) Pharmacokinetic (PK) Parameter Area Under Concentration Time Curve From Zero to Infinity (AUC0-oo)||Pre-dose (-0.5h); post-dose at 15 min, 30 min, 60 min, 2 hrs, 4 hrs, 6 hrs, 10 hrs, 24 hrs, 48 hrs, 72hrs, 96 hrs, 120 hrs and 144 hours.|Pharmacokinetic Population||ng*hr/mL||Standard Deviation|Mean
769597|NCT00706121|Other Pre-specified|Effect Modification of Vitamin E by Aspirin on CRA Occurrence, Analyzed by Active Vitamin e vs. Vitamin e Placebo||From 1 year post randomization through study completion|Marginal analyses were performed, with arms pooled based on active vs. placebo Vitamin E.||ercentage of participants in subgroup|||Number
769598|NCT00706121|Other Pre-specified|Effect Modification of Vitamin E by Body Mass Index on CRA Occurence, Analyzed by Active Vitamin e vs. Vitamin e Placebo||From 1 year post randomization through study completion|Marginal analyses were performed, with arms pooled based on active vs. placebo Vitamin E.||ercentage of participants in subgroup|||Number
769599|NCT00706121|Other Pre-specified|Effect Modification of Selenium by Aspirin on CRA Occurrence, Analyzed by Active Selenium vs. Selenium Placebo||From 1 year post randomization through study completion|Marginal analyses were performed, with arms pooled based on active vs. placebo selenium.||ercentage of participants in subgroup|||Number
769600|NCT00706121|Other Pre-specified|Effect Modification of Selenium by Body Mass Index on CRA Occurrence, Analyzed by Active Selenium vs. Selenium Placebo||From 1 year post randomization through study completion|Marginal analyses were performed, with arms pooled based on active vs. placebo selenium.||percentage of participants|||Number
769601|NCT00706121|Secondary|Effect of Vitamin E on CRA Occurrence, Analyzed by Active Vitamin E vs. Vitamin E Placebo||From 1 year post randomization through study completion|Marginal analyses were performed, with arms pooled based on active vs. placebo Vitamin E.||Participants|||Count of Participants
769602|NCT00706121|Primary|Effect of Selenium on Occurrences of Multiple (>2) Adenomas||From 1 year post randomization through study completion|Marginal analyses were performed, with arms pooled based on active vs. placebo selenium.||Participants|||Count of Participants
769603|NCT00706121|Primary|Effect of Selenium and/or Vitamin E on Colorectal Cancer (CRC) Incidence||From 1 year post randomization through study completion|||Participants|||Count of Participants
769604|NCT00706121|Primary|Effect of Selenium on Advanced Neoplasia, Analyzed by Active Selenium vs. Selenium Placebo|Adenomas with diameter >=1cm or any adenoma with villous features or high-grade dysplasia|From 1 year post randomization through study completion|Marginal analyses were performed, with arms pooled based on active vs. placebo selenium.||Participants|||Count of Participants
769605|NCT00706121|Primary|Effect of Selenium on Colorectal Adenoma (CRA) Occurrence, Analyzed by Active Selenium vs. Selenium Placebo||From 1 year post randomization through study completion|Marginal analyses were performed, with arms pooled based on active vs. placebo selenium.||Participants|||Count of Participants
769606|NCT00706134|Secondary|Change in Morning Surge of Ambulatory Systolic Blood Pressure From Baseline to End of Study (Week 8)|The morning surge was defined as the average of the hourly means in the last three hours (hours 22, 23, 24) of the 24 hour ambulatory blood pressure monitoring assessment period.|Baseline to end of study (week 8)|Ambulatory blood pressure monitoring completers population: All patients that completed both ambulatory blood pressure monitoring assessments successfully.||mmHg||Standard Error|Least Squares Mean
769607|NCT00706134|Secondary|Change in the Smoothness Index (SI) of the Ambulatory Systolic Blood Pressure From Baseline to End of Study (Week 8)|Smoothness index (SI) is a measure of consistency of the BP reduction over 24 hours. The SI was obtained by first calculating the mean blood pressure value at each hour of the 24-hour ambulatory blood pressure monitoring period, both before and during treatment. Similarly, the change from baseline in blood pressure was calculated at each hour. The average hourly change from baseline (δh) and standard deviation (std δh) of the hourly changes were computed, and the SI was derived: SI = δh/std δh. A negative change score indicates improvement.|Baseline to end of study (Week 8)|Ambulatory blood pressure monitoring completers population: All patients that completed both ambulatory blood pressure monitoring assessments successfully.||Ratio||Standard Error|Least Squares Mean
769608|NCT00706134|Secondary|Change in Mean 24 Hour Ambulatory Systolic and Diastolic Blood Pressure From Baseline to End of Study|Two 24-hour ambulatory blood pressure monitoring (ABPM) evaluations were performed, one at baseline and one at the end of the study. For each evaluation, the ABPM device was attached to the non-dominant arm of the patient.|Baseline to end of study (Week 8)|Ambulatory blood pressure monitoring completers population: All patients that completed both ambulatory blood pressure monitoring assessments successfully.||mmHg||Standard Error|Mean
769610|NCT00706134|Secondary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8)||Baseline to end of study (Week 8)|Full analysis set (FAS) - All randomized patients. Two randomized patients who did not meet study criteria were excluded from the FAS.||mmHg||Standard Error|Least Squares Mean
769614|NCT00706342|Primary|Summary of Patients Whose Platelet Count Increased by at Least 20,000/mm3 From Baseline to a Total of 30,000/mm3 or More - Month 24||24 Months|Number of participants analyzed refers to the number of patients available at this timepoint for analysis.||Participants|||Number
769615|NCT00706342|Primary|Summary of Patients Whose Platelet Count Increased by at Least 20,000/mm3 From Baseline to a Total of 30,000/mm3 or More - Month 12||12 Months|Number of participants analyzed refers to the number of patients available at this timepoint for analysis.||Participants|||Number
769616|NCT00706342|Primary|Summary of Patients Whose Platelet Count Increased by at Least 20,000/mm3 From Baseline to a Total of 30,000/mm3 or More - Week 24||24 Weeks|Number of participants analyzed refers to the number of patients available at this timepoint for analysis.||Participants|||Number
769617|NCT00706342|Primary|Summary of Patients Whose Platelet Count Increased by at Least 20,000/mm3 From Baseline to a Total of 30,000/mm3 or More - Week 12||12 Weeks|Number of participants analyzed refers to the number of patients available at this timepoint for analysis.||Participants|||Number
769618|NCT00706342|Primary|Summary of Patients Whose Platelet Count Increased by at Least 20,000/mm3 From Baseline to a Total of 30,000/mm3 or More - Week 6||6 Weeks|Number of participants analyzed refers to the number of patients available at this timepoint for analysis.||Participants|||Number
769619|NCT00706342|Primary|Summary of Patients Whose Platelet Count Increased by at Least 20,000/mm3 From Baseline to a Total of 30,000/mm3 or More - Week 2||2 weeks|Number of participants analyzed refers to the number of patients available at this timepoint for analysis.||Participants|||Number
769620|NCT00706355|Secondary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.|Baseline until disease progression up to C2 D1|Efficacy analysis set included all enrolled participants who received the study treatment and had measurable disease at baseline.||Percentage of participants||95% Confidence Interval|Number
769621|NCT00706355|Secondary|Change From Baseline in Tumor Proliferation Using F-Fluoro-3'-Deoxy-3’-L-Fluorothymidine Positron Emission Tomography (FLT-PET) Imaging at Day 1 of Cycle 2|F-fluoro-3'-deoxy-3’-L-fluorothymidine positron emission tomography (FLT-PET) imaging was used to assess the tumor proliferation in RP2D cohorts. Results of the FLT-PET were scored according to the methods developed by the American College of Radiology Imaging Network (ACRIN).|Cycle 2 Day 1|Data was not analyzed due to insufficient number of participants enrolled.||Standardized Uptake Value (SUV)||Standard Deviation|Mean
769622|NCT00706355|Secondary|Apparent Oral Clearance (CL/F) for PF-04217903|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. Participants did not receive 200 mg twice a day dose of study treatment for this specific measure.|0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C2 D1|The PK parameter analysis population included all enrolled participants who received the study medication and had at least 1 of the PK parameters of interest. 'N' (number of participants analyzed) signifies those participants evaluable for this measure.||Liter/hr (L/hr)||Standard Deviation|Geometric Mean
769623|NCT00706355|Secondary|Metabolite to Parent Ratio Area Under the Curve From Time Zero to End of Dosing Interval (MRAUCtau)|Molar ratio of metabolite to parent area under the plasma concentration time-curve from zero (pre-dose) to end of dosing interval (MRAUCtau).|0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C1 D1 and C2 D1|The PK parameter analysis population included all enrolled participants who received the study medication and had at least 1 of the PK parameters of interest. ‘n’ signifies those participants evaluated for this measure at specific time point for each arm group respectively.||Ratio||Standard Deviation|Mean
769624|NCT00706355|Secondary|Accumulation Ratio (Rac) for PF-04217903 and PF-04217903 Metabolite (PF-04328029)|Rac is obtained from AUCtau (Cycle 2 Day 1) divided by AUCtau (Cycle 1 Day 1). Participants did not receive 200 mg twice a day dose of study treatment for this specific measure.|0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C2 D1|The PK parameter analysis population included all enrolled participants who received the study medication and had at least 1 of the PK parameters of interest. ‘n’ signifies those participants evaluated for this measure at specific time point for each arm group respectively.||Ratio||Standard Deviation|Mean
769625|NCT00706355|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval [AUC(0-tau)] for PF-04217903 and PF-04217903 Metabolite (PF-04328029)|Area under the concentration-time profile from time zero to time tau (dosing interval), where tau is equal to 12 hours.|0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C1 D1 and C2 D1|The PK parameter analysis population included all enrolled participants who received the study medication and had at least 1 of the PK parameters of interest. ‘n’ signifies those participants evaluated for this measure at specific time point for each arm group respectively.||ng*hr/mL||Standard Deviation|Geometric Mean
769626|NCT00706355|Secondary|Area Under the Plasma Concentration Time-curve From Zero to the Last Measured Concentration [AUC(0-last)] for PF-04217903 and PF-04217903 Metabolite (PF-04328029)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).|0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C1 D1 and C2 D1|The PK parameter analysis population included all enrolled participants who received the study medication and had at least 1 of the PK parameters of interest. ‘n’ signifies those participants evaluated for this measure at specific time point for each arm group respectively.||ng*hr/mL||Standard Deviation|Geometric Mean
769627|NCT00706355|Secondary|Pre-dose Plasma Concentration (Ctrough) for PF-04217903 and PF-04217903 Metabolite (PF-04328029)|Participants did not receive 200 mg twice a day dose of study treatment for this specific measure.|0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C1 D1 and C2 D1|The PK parameter analysis population included all enrolled participants who received the study medication and had at least 1 of the PK parameters of interest. ‘n’ signifies those participants evaluable for this measure.||ng/mL||Standard Deviation|Geometric Mean
769628|NCT00706355|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-04217903 and PF-04217903 Metabolite (PF-04328029)||0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C1 D1 and C2 D1|The PK parameter analysis population included all enrolled participants who received the study medication and had at least 1 of the PK parameters of interest. ‘n’ signifies those participants evaluated for this measure at specific time point for each arm group respectively.||hr||Full Range|Median
769629|NCT00706355|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) for PF-04217903 and PF-04217903 Metabolite (PF-04328029)|Participants did not receive 200 mg twice a day dose of study treatment for this specific measure.|0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C2 D1|The PK parameter analysis population included all enrolled participants who received the study medication and had at least 1 of the PK parameters of interest. ‘n’ signifies those participants evaluated for this measure at specific time point for each arm group respectively.||ng/mL||Standard Deviation|Geometric Mean
769630|NCT00706355|Secondary|Maximum Observed Plasma Concentration (Cmax) for PF-04217903 and PF-04217903 Metabolite (PF-04328029)||0 (pre-dose), 1, 2, 4, 6, 8 and 12 hours (hrs) (just prior to evening dosing) post dose on Cycle (C) 1 Day (D) 1 and C2 D1|The pharmacokinetic (PK) parameter analysis population included all enrolled participants who received the study medication and had at least 1 of the PK parameters of interest. 'n’ signifies those participants evaluated for this measure at specific time point for each arm group respectively.||Nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
769631|NCT00706355|Primary|Number of Participants With Dose-Limiting Toxicities (DLTs)|DLT includes Gr 2 elevated creatinine and acute renal failure, Gr 3 thrombocytopenia with bleeding, hypertension (if unmanageable), Gr >= 3 non-hematological non-disease-related (NDR) toxicities (except alopecia, Gr 3/4 hypophosphatemia, hyperuricemia), Gr 3/4 nausea, vomiting, diarrhea, Gr 4 neutropenia, thrombocytopenia lasting for >= 7 days, febrile neutropenia, neutropenic infection, inability to deliver at least 80 percent of planned dose during Cycle 1 due to NDR adverse events.|Baseline up to 21 days after the start of each increased treatment dose|DLT analysis set: participants who received first cycle of study medication and did not temporarily or permanently discontinue from study medication or missed more than 3 consecutive days of PF-04217903 dosing for reasons other than DLTs within first cycle.||Participants|||Number
769632|NCT00706355|Primary|Recommended Phase 2 Dose (RP2D)||Baseline up to 21 days after the start of each increased treatment dose|Data was not analyzed due to insufficient number of participants enrolled.||mg|||Number
769633|NCT00706355|Primary|Maximum Tolerated Dose (MTD)|MTD: dose level at which 1 of 6 participants experienced dose-limiting toxicity (DLT) after 21 days of treatment (Cycle 1). DLT: grade (Gr) 2 elevated creatinine, acute renal failure, Gr 3 thrombocytopenia with bleeding, hypertension (if unmanageable),Gr >=3 non-hematological non-disease-related (NDR) toxicities (except alopecia,Gr 3/4 hypophosphatemia, hyperuricemia), Gr 3/4 nausea, vomiting, diarrhea, Gr 4 neutropenia, thrombocytopenia lasting for >=7 days, febrile neutropenia, neutropenic infection, inability to deliver 80 percent of planned dose during Cycle 1 due to NDR toxicities.|Baseline up to 21 days after the start of each increased treatment dose|Analysis population included all enrolled participants who received at least 1 dose of the study treatment.||mg|||Number
769634|NCT00706433|Secondary|Oozing/Vesiculation/Crusting at Visit 10 (6 Weeks After Final PDT)|﻿OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal – a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild – two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate – more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe – any degree of oozing, vesiculation or crusting greater than (3) above|Visit 10 (6 Weeks after Final PDT)|ITT observed||particpants|||Number
769635|NCT00706433|Secondary|Oozing/Vesiculation/Crusting at Visit 9 (3 Weeks After Final PDT)|﻿OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal – a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild – two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate – more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe – any degree of oozing, vesiculation or crusting greater than (3) above|Visit 9 (3 Weeks after Final PDT)|ITT observed||participants|||Number
769636|NCT00706433|Secondary|Oozing/Vesiculation/Crusting at Visit 7 (Week 9)|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal – a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild – two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate – more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe – any degree of oozing, vesiculation or crusting greater than (3) above|Visit 7 (Week 9)|ITT observed||participants|||Number
769637|NCT00706433|Secondary|Oozing/Vesiculation/Crusting at Visit 5 (Week 6)|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal – a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild – two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate – more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe – any degree of oozing, vesiculation or crusting greater than (3) above|Visit 5 (Week 6)|ITT observed||participant|||Number
769638|NCT00706433|Secondary|Oozing/Vesiculation/Crusting at Visit 3 (Week 3)|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal – a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild – two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate – more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe – any degree of oozing, vesiculation or crusting greater than (3) above|Visit 3 (Week 3)|ITT observed||participants|||Number
769904|NCT00707655|Secondary|Best Overall Tumour Response|Best overall tumor response according to RECIST criteria J Natl Cancer Inst 2000;92:205-16 assessed by CT/MRI. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the longest diameter of target lesions; Overall Response (OR), CR+PR|2 years|||participants|||Number
769639|NCT00706433|Secondary|Oozing/Vesiculation/Crusting 48 Hours After PDT #1|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal – a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild – two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate – more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe – any degree of oozing, vesiculation or crusting greater than (3) above|48 hours after PDT #1|ITT observed||participants|||Number
769640|NCT00706433|Secondary|Scaling and Dryness at Visit 10 (6 Weeks After Final PDT)|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal – barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate – fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe – coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Visit 10 (6 Weeks after Final PDT)|ITT observed||participants|||Number
769641|NCT00706433|Secondary|Scaling and Dryness at Visit 9 (3 Weeks After Final PDT)|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal – barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate – fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe – coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Visit 9 (3 Weeks after Final PDT)|ITT observed||participants|||Number
769642|NCT00706433|Secondary|Scaling and Dryness at Visit 7 (Week 9)|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal – barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate – fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe – coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Visit 7 (Week 9)|ITT observed||participants|||Number
769643|NCT00706433|Secondary|Scaling and Dryness at Visit 5 (Week 6)|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal – barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate – fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe – coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Visit 5 (Week 6)|ITT observed||participants|||Number
769644|NCT00706433|Secondary|Scaling and Dryness at Visit 3 (Week 3)|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal – barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate – fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe – coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Visit 3 (Week 3)|ITT observed||participants|||Number
769645|NCT00706433|Secondary|Scaling and Dryness 48 Hours After PDT #1|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal – barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate – fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe – coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|48 hours after PDT #1|ITT observed||participants|||Number
769646|NCT00706433|Secondary|Stinging/Burning at Visit 10 (6 Weeks After Final PDT)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|Visit 10 (6 Weeks after Final PDT)|ITT observed||participants|||Number
769647|NCT00706433|Secondary|Stinging/Burning at Visit 9 (3 Weeks After Final PDT)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|Visit 9 (3 Weeks after Final PDT)|ITT observed||participants|||Number
769648|NCT00706433|Secondary|Stinging/Burning at Visit 7 (Week 9 - Post Light Treatment)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|Visit 7 (Week 9 - post light treatment)|ITT observed||participants|||Number
769649|NCT00706433|Secondary|Stinging/Burning at Visit 7 (Week 9 - During Light Treatment)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|Visit 7 (Week 9 - during light treatment)|ITT observed||participants|||Number
769650|NCT00706433|Secondary|Stinging/Burning at Visit 7 (Week 9 - Prior to Light Treatment)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|Visit 7 (Week 9 - prior to light treatment)|ITT observed||participants|||Number
769651|NCT00706433|Secondary|Stinging/Burning at Visit 7 (Week 9 - Before Study Drug Application)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|Visit 7 (Week 9 - before study drug application)|ITT observed||participants|||Number
769652|NCT00706433|Secondary|Stinging/Burning at Visit 5 (Week 6 - Post Light Treatment)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|Visit 5 (Week 6 - post light treatment)|ITT observed||participants|||Number
769653|NCT00706433|Secondary|Stinging/Burning at Visit 5 (Week 6 - During Light Treatment)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|Visit 5 (Week 6 - during light treatment)|ITT observed||participants|||Number
769905|NCT00707655|Primary|Adverse Events|Number of participants with at least one adverse event. All adverse events are collected during 12 weeks and all serious adverse events are collected during 2 years.|Overall study|||participants|||Number
769654|NCT00706433|Secondary|Stinging/Burning at Visit 5 (Week 6 - Prior to Light Treatment)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|Visit 5 (Week 6 - prior to light treatment)|ITT observed||participants|||Number
769655|NCT00706433|Secondary|Stinging/Burning at Visit 5 (Week 6 - Before Study Drug Application)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|Visit 5 (Week 6 - before study drug application)|ITT observed||participants|||Number
769656|NCT00706433|Secondary|Stinging/Burning at Visit 3 (Week 3 - Post Light Treatment)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|Visit 3 (Week 3 - post light treatment)|ITT observed||participants|||Number
769657|NCT00706433|Secondary|Stinging/Burning at Visit 3 (Week 3 - During Light Treatment)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|Visit 3 (Week 3 - during light treatment)|ITT observed||participants|||Number
769658|NCT00706433|Secondary|Stinging/Burning at Visit 3 (Week 3 - Before Light Treatment)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|Visit 3 (Week 3 - before light treatment)|ITT observed||participants|||Number
769659|NCT00706433|Secondary|Stinging/Burning at Visit 3 (Week 3 - Before Study Drug Application)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|Visit 3 (Week 3 - before study drug application)|ITT observed||participants|||Number
769660|NCT00706433|Secondary|Stinging/Burning 48 Hours Post PDT #1|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|48 hours post PDT #1|ITT observed||participants|||Number
769661|NCT00706433|Secondary|Stinging/Burning at Baseline - Post Light Treatment|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|Baseline - post light treatment|ITT observed||participants|||Number
769662|NCT00706433|Secondary|Stinging/Burning at Baseline - During Light|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|Baseline - during light|ITT observed||participants|||Number
769663|NCT00706433|Secondary|Stinging/Burning at Baseline - Before Light Treatment|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|Baseline - before light treatment|ITT observed||participants|||Number
769664|NCT00706433|Secondary|Edema 6 Weeks After Final PDT|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal – scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|6 weeks after final PDT|ITT observed||participants|||Number
769665|NCT00706433|Secondary|Edema 3 Weeks After Final PDT|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal – scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|3 weeks after final PDT|ITT observed||participants|||Number
769666|NCT00706433|Secondary|Edema at Visit 7 (Week 9 - Post Light Treatment)|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal – scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Visit 7 (Week 9 - post light treatment)|ITT observed||participants|||Number
769667|NCT00706433|Secondary|Edema at Visit 7 (Week 9 - Prior to Light Treatment)|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal – scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Visit 7 (Week 9 - prior to light treatment)|ITT observed||participants|||Number
769668|NCT00706433|Secondary|Edema at Visit 7 (Week 9 - Before Study Drug Application)|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal – scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Visit 7 (Week 9 - before study drug application)|ITT observed||participants|||Number
769669|NCT00706433|Secondary|Edema at Visit 5 (Week 6 - Post Light Treatment)|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal – scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Visit 5 (Week 6 - post light treatment)|ITT observed||participants|||Number
769709|NCT00706433|Primary|Investigator Global Assessment of Acne Severity Successes|Scale consists of Grade 0 (clear skin) to Grade 4 (severe: up to many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions) This assessment uses a dichotomized success/failure assessment - with success defined as a 2 point or more improvement on the IGA scale since baseline.|Baseline and 3 weeks after final treatment|ITT LOCF||participants|||Number
769670|NCT00706433|Secondary|Edema at Visit 5 (Week 6 - Pre Light Treatment)|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal – scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Visit 5 (Week 6 - pre light treatment)|ITT observed||participants|||Number
769671|NCT00706433|Secondary|Edema at Visit 5 (Week 6 - Before Study Drug Application)|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal – scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Visit 5 (Week 6 - before study drug application)|ITT observed||participants|||Number
769672|NCT00706433|Secondary|Edema at Visit 3 (Week 3 - Post Light Treatment)|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal – scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Visit 3 (Week 3 - post light treatment)|ITT observed||participants|||Number
769673|NCT00706433|Secondary|Edema at Visit 3 (Week 3 - Before Light Treatment)|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal – scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Visit 3 (Week 3 - before light treatment)|ITT observed||participants|||Number
769674|NCT00706433|Secondary|Edema at Visit 3 (Week 3 - Before Study Drug Application)|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal – scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Visit 3 (Week 3 - before study drug application)|ITT observed||participants|||Number
769675|NCT00706433|Secondary|Edema 48 Hours After PDT #1|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal – scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|48 hours after PDT #1|ITT observed||participants|||Number
769676|NCT00706433|Secondary|Edema at Baseline - Post Light Treatment|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal – scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Baseline - Post Light Treatment|ITT observed||participants|||Number
769677|NCT00706433|Secondary|Edema at Baseline - Pre Light Treatment|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal – scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Baseline - pre light treatment|ITT observed||participants|||Number
769678|NCT00706433|Secondary|Erythema 6 Weeks After Final PDT|Grade 0 = None Grade 1 = Minimal – barely perceptible erythema Grade 2 = Mild – predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate – predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe – predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|6 Weeks after Final PDT|ITT observed||participants|||Number
769679|NCT00706433|Secondary|Erythema 3 Weeks After Final PDT|Grade 0 = None Grade 1 = Minimal – barely perceptible erythema Grade 2 = Mild – predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate – predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe – predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|3 Weeks after Final PDT|ITT observed||participants|||Number
769680|NCT00706433|Secondary|Erythema at Visit 7 (Week 9 - Post Light Treatment)|Grade 0 = None Grade 1 = Minimal – barely perceptible erythema Grade 2 = Mild – predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate – predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe – predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Visit 7 (Week 9 - post light treatment)|ITT, observed||participant|||Number
769681|NCT00706433|Secondary|Erythema at Visit 7 (Week 9 - Pre Light Treatment)|Grade 0 = None Grade 1 = Minimal – barely perceptible erythema Grade 2 = Mild – predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate – predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe – predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Visit 7 (Week 9 - pre light treatment)|ITT observed||participants|||Number
769682|NCT00706433|Secondary|Erythema at Visit 7 (Week 9 - Prior to Study Drug Application)|Grade 0 = None Grade 1 = Minimal – barely perceptible erythema Grade 2 = Mild – predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate – predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe – predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Visit 7 (Week 9 - prior to study drug application)|ITT observed||participants|||Number
769683|NCT00706433|Secondary|Erythema at Visit 5 (Week 6 - Post Light Treatment)|Grade 0 = None Grade 1 = Minimal – barely perceptible erythema Grade 2 = Mild – predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate – predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe – predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Visit 5 (Week 6 - post light treatment)|ITT, observed||participants|||Number
769684|NCT00706433|Secondary|Erythema at Visit 5 (Weeks 6 - Pre-light Treatment)|Grade 0 = None Grade 1 = Minimal – barely perceptible erythema Grade 2 = Mild – predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate – predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe – predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Visit 5 (Weeks 6 - pre-light treatment)|ITT, observed||participants|||Number
769685|NCT00706433|Secondary|Erythema at Visit 5 (Week 6 - Prior to Study Drug Application)|Grade 0 = None Grade 1 = Minimal – barely perceptible erythema Grade 2 = Mild – predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate – predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe – predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Visit 5 (Week 6 - prior to study drug application)|ITT, observed||participants|||Number
769686|NCT00706433|Secondary|Erythema at Visit 3 (Week 3 - Post Light Treatment)|Grade 0 = None Grade 1 = Minimal – barely perceptible erythema Grade 2 = Mild – predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate – predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe – predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Visit 3 (Week 3 - post light treatment)|ITT, observed||participants|||Number
769687|NCT00706433|Secondary|Erythema at Visit 3 (Week 3 - Pre-light)|Grade 0 = None Grade 1 = Minimal – barely perceptible erythema Grade 2 = Mild – predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate – predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe – predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Visit 3 (Week 3 - pre-light)|ITT, observed||participants|||Number
769688|NCT00706433|Secondary|Erythema at Visit 3 (Week 3 - Pre Study Drug Application)|Grade 0 = None Grade 1 = Minimal – barely perceptible erythema Grade 2 = Mild – predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate – predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe – predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Visit 3 (Week 3 - pre study drug application)|ITT, observed||participants|||Number
769689|NCT00706433|Secondary|Erythema 48 Hours After PDT #1|Grade 0 = None Grade 1 = Minimal – barely perceptible erythema Grade 2 = Mild – predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate – predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe – predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|48 hours after PDT #1|ITT, observed||participants|||Number
769690|NCT00706433|Secondary|Erythema at Baseline - Post Light Treatment|Grade 0 = None Grade 1 = Minimal – barely perceptible erythema Grade 2 = Mild – predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate – predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe – predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Baseline - post light treatment|ITT observed||participants|||Number
769691|NCT00706433|Secondary|Erythema at Baseline (Pre-light)|"After solution application, prior to light treatment
﻿ Grade 0 = None Grade 1 = Minimal – barely perceptible erythema Grade 2 = Mild – predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate – predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe – predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema"|Baseline (pre-light)|ITT, observed||participants|||Number
769692|NCT00706433|Secondary|Hypopigmentation at Visit 10 (6 Weeks After Final PDT)|﻿ HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|Visit 10 (6 weeks after final PDT)|ITT, observed||participants|||Number
769693|NCT00706433|Secondary|Hypopigmentation at Visit 9 (3 Weeks After Final PDT)|﻿ HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|Visit 9 (3 weeks after final PDT)|ITT, observed||participants|||Number
769710|NCT00706433|Primary|Change in Inflammatory Lesion Counts Relative to Baseline||Baseline and 3 weeks after final treatment|ITT analysis, LOCF||change in lesion count||Standard Deviation|Median
769694|NCT00706433|Secondary|Hypopigmentation at Visit 7 (Week 9)|﻿ HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|Visit 7 (Week 9)|ITT, observed||participants|||Number
769695|NCT00706433|Secondary|Hypopigmentation at Visit 5 (Week 6)|﻿ HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|Visit 5 (Week 6)|ITT, observed||participants|||Number
769696|NCT00706433|Secondary|Hypopigmentation at Visit 3 (Week 3)|﻿ HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|Visit 3 (Week 3)|ITT, observed||participants|||Number
769697|NCT00706433|Secondary|Hypopigmentation 48 Hours Post PDT #1|﻿ HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|48 hours post PDT #1|ITT, observed||participants|||Number
769698|NCT00706433|Secondary|Hyperpigmentation at Visit 10 (6 Weeks After Final PDT)|﻿ HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Visit 10 (6 weeks after final PDT)|ITT, observed||participants|||Number
769699|NCT00706433|Secondary|Hyperpigmentation at Visit 9 (3 Weeks After Final PDT)|﻿ HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Visit 9 (3 weeks after final PDT)|ITT, observed||participants|||Number
769700|NCT00706433|Secondary|Hyperpigmentation at Visit 7 (Week 9)|﻿ HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Visit 7 (Week 9)|ITT, observed||participant|||Number
769701|NCT00706433|Secondary|Hyperpigmentation at Visit 5 (Week 6)|﻿ HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Visit 5 (Week 6)|ITT, observed||participants|||Number
769702|NCT00706433|Secondary|Hyperpigmentation at Visit 3 (Week 3)|﻿ HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Visit 3 (Week 3)|ITT, observed||participants|||Number
769703|NCT00706433|Secondary|Hyperpigmentation 48 Hours After PDT #1|﻿ HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|48 hours after PDT #1|ITT, observed||participants|||Number
769704|NCT00706433|Secondary|Investigator Global Assessment of Acne Severity Successes|"Assessment uses a dichotomized success/failure assessment with success defined as a 2 point or more improvement since baseline.
﻿0 Clear skin with no inflam or non-inflam lesions
Almost clear; rare non-inflam lesions with no more than a few small inflam lesions
Mild; > Grade 1; some non-inflam lesions with some inflam lesions (papules/pustules only; no nodules)
Moderate; > Grade 2; up to many non-inflam lesions and a moderate number of inflam lesions but no more than one small nodule
Severe; > Grade 3; up to many non-inflam and inflam lesions, but no more than a few nodules"|Baesline and 6 weeks after final treatment|ITT LOCF||participants|||Number
769705|NCT00706433|Secondary|Change in Inflammatory Lesion Counts Relative to Baseline|change in lesion counts compared to baseline|Baseline and 6 weeks after final treatment|ITT LOCF||change in lesion count||Standard Deviation|Median
769706|NCT00706433|Secondary|Subject Satisfaction Score|"Subject satisfaction score
= Excellent (very satisfied)
= Good (moderately satisfied)
= Fair (slightly satisfied)
= Poor (not satisfied at all)"|6 weeks after final treatment|ITT, observed||participants|||Number
769707|NCT00706433|Secondary|Percent Change in Inflammatory Lesion Counts Relative to Baseline||Baseline and 6 weeks after final treatment|ITT LOCF||percent change in lesion count||Standard Deviation|Median
769708|NCT00706433|Secondary|Percent Change in Inflammatory Lesion Counts Relative to Baseline||Baseline and 3 weeks after final treatment|ITT LOCF||percent change in lesion count||Standard Deviation|Median
769717|NCT00706485|Secondary|Number of Participants With Local Control|Local failure is defined as: extension of the tumor margin[s] in any direction at least 5 mm beyond that present on the pre-treatment imaging studies or the appearance of -tumor in tissues previously scored as sites of sub-clinical disease. Local control is absence of local failure.|at 6 weeks and at three months after therapy, and every 6 months thereafter for four years, and then annually to year 10|||participants|||Number
769718|NCT00706485|Primary|Number of Participants With Successful Titanium-enclosed and Differentially-loaded Y-90 Dural Brachytherapy Plaque Fabrication and Use||At time of procedure|||participants|||Number
769719|NCT00706550|Primary|Opsonophagocytic Killing Activity (OPA)|This assay helps us to know how the antibody produced by the body are working to kill the bacteria against which the antibody is produced. This point of time (one-month after vaccine), gives the information about how much the killing activity increased 1 month after the vaccine was administered.|One-month post-vaccine|||Titers||Full Range|Geometric Mean
769720|NCT00706550|Primary|Opsonophagocytic Killing Activity (OPA)|This assay helps us to know how the antibody produced by the body are working to kill the bacteria against which the antibody is produced. As explained previously for the immunoglobulins' assays, we measure the baseline point to be able to determine the increase after the vaccine is administered.|Baseline|||Titers||Full Range|Geometric Mean
769721|NCT00706550|Primary|IgM Levels|Immunoglobulins are antibodies or special proteins that the immune system produces to protect the body against infections. IgM is the first antibody produced by the immune system to fight a new infection. This point of time (one-month after vaccine), gives the information about how much antibody was produced by the participant's immune system in response to the vaccine.|One-month post-vaccine|||Micrograms/ml||Full Range|Geometric Mean
769722|NCT00706550|Primary|Immunoglobulin M (IgM) Levels|Immunoglobulins are antibodies or special proteins that the immune system produces to protect the body against infections. IgM is the first antibody produced by the immune system to fight a new infection. We measure baseline levels (before the vaccine is administered) to know how much antibody the subject has at the start point to be able to evaluate how much antibody is produced after the vaccine is administered.|Baseline|||Micrograms/ml||Full Range|Geometric Mean
769723|NCT00706550|Primary|IgG Levels|Immunoglobulins are antibodies or special proteins that the immune system produces to protect the body against infections. IgG is the most common antibody. This point of time (one-month after vaccine), gives the information about how much antibody was produced by the participant's immune system in response to the vaccine.|One-month post-vaccine|||Micrograms/ml||Full Range|Geometric Mean
769724|NCT00706550|Primary|Immunoglobulin G (IgG) Levels|Immunoglobulins are antibodies or special proteins that the immune system produces to protect the body against infections. IgG is the most common antibody. We measure baseline levels (before the vaccine is administered) to know how much antibody the subject has at the start point to be able to evaluate how much antibody is produced after the vaccine is administered.|Baseline|||Micrograms/ml||Full Range|Geometric Mean
769725|NCT00706563|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|During the 21-day (Day 0-20) post-vaccination period|||subjects|||Number
769726|NCT00706563|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|During the 21-day (Day 0-20) post-vaccination period|||subjects|||Number
769727|NCT00706563|Secondary|Number of Subjects Reporting Solicited Symptoms|"Solicited local symptoms assessed include ecchymosis, induration, pain, redness, and swelling.
Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, shivering, sweating, and fever"|During the 4-day (Day 0-3) post-vaccination period|||subjects|||Number
769728|NCT00706563|Primary|Seroprotection Power|Seroprotection power is defined as the number of subject who had a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:40|At Day 21|Analysis was performed on the According-To-Protocol (ATP) cohort for analysis of immunogenicity, on subjects unprotected at pre-vaccination and with available results||subjects|||Number
769729|NCT00706563|Primary|Serconversion Factor|Seroconversion factor, defined as the fold increase in serum HI GMT post-vaccination compared to pre-vaccination (Day 0), is presented for all three vaccine influenza virus strains|At Day 21|||factor|||Number
769730|NCT00706563|Primary|Number of Serconverted Subjects|A seroconverted subject is a subject with a pre-vaccination serum HI titer < 1:10 and a post-vaccination serum HI titer ≥ 1:40, or a pre-vaccination serum HI titer ≥ 1:10 and a fold increase (Day 21/Day 0) ≥ 4|At Day 21|||subjects|||Number
769731|NCT00706563|Primary|Number of Seroprotected Subjects|A seroprotected subject is a subject with a serum HI antibody titer ≥ 1:40|At Day 0 and 21|||subjects|||Number
769732|NCT00706563|Primary|Number of Subjects With HI Antibody Titer Above the Cut-off Value|The cut-off value assessed was ≥ 1:10 and was presented for all three vaccine influenza virus strains|At Day 0 and 21|||subjects|||Number
769733|NCT00706563|Primary|Hemagglutination Inhibition (HI) Antibody Titer|Titers given as geometric mean titer (GMT) were presented for all three vaccine influenza virus strains|At Day 0 and 21|||titer||95% Confidence Interval|Geometric Mean
769734|NCT00706589|Primary|Mean Change of Total Tic Scores in K-YGTSS From Randomization (Baseline, Visit 2) to the Final Visit (Visit 7)|The meaning of the total tic scores is a sum of the total motor tic score and total phonic tic score and the total tic score will be indicated from zero point to 50 points. And also, for the global tic severity scale is sum of the total tic scores and impairment score and it will be indicated from zero point to 100 points. Additionally, for the imparment score is also indicated from zero to 50 points same as total tic scores. And it is divided as 0 point, 10 point, 20 point and etc… Lastly, someone who gets a high score, it will be considered worse result.|10 week|ITT (Intention-To-Treat)analysis||units on a scale||Full Range|Mean
769735|NCT00706589|Secondary|1)Percent Change of Total Tic Scores on the Korean Version of YaleGlobalTicseverity Scale.2)Response Rate Assessed With the Tic Score ClinicalGlobalImpressionImprovementScale.3)Mean Change in Scores on the Tic Score ClinicalGlobal ImpressionSeverityScale.||10 weeks||||||
769928|NCT00707759|Primary|Stimulation of Growth After 12 Months (Delta Z-score)||12 months|||units on a scale||Standard Deviation|Mean
769736|NCT00706628|Secondary|Trough Plasma Concentrations for BIBF 1120 and BIBW 2992 for the Combination Therapy|"Trough plasma concentrations are defined either as pre-dose concentration of BIBF 1120 and BIBW 2992 in plasma at steady state immediately before administration of the next dose for the monotherapy treatment or as post dose concentrations taken after the dosing interval for the combination treatment (C12,14 for BIBF1120 ; C24,7 and C24,14 for BIBW2992)
C12,14: plasma concentration at 12 hours Day 14"|Day7, Day 14|Pharmacokinetics (PK) data set: All patients from whom PK samples were received in the bioanalytical laboratories were included in the PK analysis.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
769737|NCT00706628|Secondary|Trough Plasma Concentrations for BIBF 1120 and BIBW 2992 for the Monotherapy|Trough plasma concentrations are defined either as pre-dose concentration of BIBF 1120 and BIBW 2992 in plasma at steady state immediately before administration of the next dose for the monotherapy treatment or as post dose concentrations taken after the dosing interval for the combination treatment|Day 15, Day 29 and Day 57|Pharmacokinetics (PK) data set: All patients from whom PK samples were received in the bioanalytical laboratories were included in the PK analysis.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
769738|NCT00706628|Secondary|Changes in Safety Laboratory Parameters|Changes in safety laboratory Parameters reported as adverse events|from first intake of treatment until 29 days after last intake of treatment (Up to 52 weeks)|Treated Set||percentage of participants|||Number
769739|NCT00706628|Secondary|Incidence and Worst Intensity of Adverse Events With Grading According CTCAE|Incidence and worst intensity of Adverse Events with grading according to the Common Terminology Criteria for Adverse Events (CTCAE version 3.0).|from first intake of treatment until 29 days after last intake of treatment (Up to 52 weeks)|Treated Set||percentage of participants|||Number
769740|NCT00706628|Secondary|Overall Survival (Time to Death)|Overall survival (time to death) was calculated in days from baseline to the date of reporting of death. Time is expressed in Median number of days.|start of treatment until 28 days after end of treatment (Up to 52 weeks)|FAS||days||95% Confidence Interval|Median
769741|NCT00706628|Secondary|Time to Progression|"Time from first administration of study drug until disease progression according to composite endpoint.
Time is expressed in Median number of days."|start of treatment until end of the treatment (Up to 48 weeks)|FAS||days||95% Confidence Interval|Median
769742|NCT00706628|Secondary|Duration of RECIST Response|"Time from first observation of response (PR, CR, confirmed or unconfirmed) until progression according to RECIST (version 1.0) or death.
Duration is expressed in Median number of days."|Up to 48 weeks|FAS (RECIST evaluable set)||days||Inter-Quartile Range|Median
769743|NCT00706628|Secondary|Overall Objective Response by RECIST Criteria (Version 1.0) (Complete Response [CR] or Partial Response [PR]) for Patients With Measurable Disease at 12, 24, 36 and 48 Weeks|Objective response is defined as a Complete or Partial response Complete response [CR] for Target lesions: Disappearance of all target lesions. Complete response [CR] for Non- target lesions: Disappearance of all non-target lesions and normalization of tumour marker level Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|12, 24, 36 and 48 weeks|FAS (RECIST evaluable set)||percentage of participants|||Number
769744|NCT00706628|Secondary|RECIST Tumour Progression Rate at 12, 24, 36, and 48 Weeks|RECIST (version 1.0) tumour progression rate at 12, 24, 36, and 48 weeks was calculated based on the occurrence of new lesions, or an increase in the sum of the longest lesion diameters of at least 20%.|12, 24, 36, and 48 weeks|FAS (RECIST evaluable set); RECIST evaluable set, which consisted of patients who had RECIST measurable disease at baseline.||percentage of participants|||Number
769745|NCT00706628|Secondary|Time to PSA Progression|"Time to PSA progression through 48 weeks was calculated as the number of days from first administration of study drug to the first time that there was an increase of 50% from the PSA nadir, provided the absolute increase was at least 5 ng/mL.
Time is expressed in median number of days."|Start of treatment until end of treatment (Up to 48 weeks)|FAS||days||95% Confidence Interval|Median
769746|NCT00706628|Secondary|Duration of PSA Response|"Duration of PSA response was calculated from the time of first 50% decline in PSA (compared to baseline) until the time at which there was an increase of 50% from the PSA nadir, provided that the absolute increase was at least 5 ng/mL. The increase had to be confirmed by a second consecutive measurement that was at least 50% above the nadir. If the PSA never showed a 50% increase over the nadir value, then the patient was censored at the last PSA measurement.
Duration of PSA response expressed in median number of days."|End of trial visit, 29 ± 1 days after Day 1 of the last treatment cycle (Up to 48 weeks)|FAS||days||Inter-Quartile Range|Median
769747|NCT00706628|Secondary|Number of Patients Showing Prostate Serum Antigen (PSA) Response|"PSA response was evaluated according to the PSAWG guidelines. All patients achieving a fall in PSA of ≥50% from baseline (confirmed with a second value at least 4 weeks later) fulfilled the criteria for PSA response. The confirmatory value had to be at least 50% lower than the baseline value, but could be higher than the original drop in PSA (first PSA value).
However, the confirmatory value could not be 50% higher than the first PSA value. If it was ≥50% higher than the first PSA, another sample was taken to determine if response had been achieved."|End of trial visit, 29 ± 1 days after Day 1 of the last treatment cycle (Up to 48 weeks)|FAS||percentage of participants|||Number
769748|NCT00706628|Secondary|Progression Free Rate at 24 and 48 Weeks|"PFR is defined as a composite endpoint for disease progression.
If patients met one of the following criteria they were counted as having progressive disease (PD):
Prostate serum antigen (PSA) progression according to Prostate-Specific Antigen Working Group (PSAWG) criteria
Bone metastasis progression- development of new lesions on bone scan or development of disease-related skeletal related events (SREs)
Disease progression according to RECIST version 1.0"|24 weeks and 48 weeks|"Full analysis set (FAS), which consisted of all patients who received at least
1 dose of study medication and for whom progression status could be determined at 12 weeks."||percentage of participants||95% Confidence Interval|Number
769787|NCT00706797|Secondary|Change From Baseline in Erosions at Week 52|Erosion score (a component of the modified TSS) is a measure of change in joint health. Erosion score range is from 0 (no erosion) to 280 (high erosion). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.|Baseline, Week 52|mITT; efficacy data not analyzed due to early termination of the study.||scores on a scale||Standard Deviation|Mean
769749|NCT00706628|Primary|Progression Free Rate (PFR) at 12 Weeks|"PFR is defined as a composite endpoint for disease progression.
If patients met one of the following criteria they were counted as having progressive disease (PD):
Prostate serum antigen (PSA) progression according to Prostate-Specific Antigen Working Group (PSAWG) criteria
Bone metastasis progression- development of new lesions on bone scan or development of disease-related skeletal related events (SREs)
Disease progression according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.0"|12 weeks|Modified full analysis set(mFAS): Patients who received at least 1 dose of study medication and for whom progression status could be determined at 12 weeks,excluding patients who discontinued treatment before 12 weeks for reasons other than PD.||percentage of participants||95% Confidence Interval|Number
769750|NCT00706641|Secondary|Increase in Cas3 Expression|Cas3 levels were analyzed pre and post treatment|Baseline to post dasatinib therapy|Sufficient tumor suitable for Immuno-Histochemistry (IHC) analysis was available from 20 patients||participants|||Number
769751|NCT00706641|Secondary|Reduced Ki-67 Expression|Ki-67 levels were analyzed pre and post treatment|Baseline to post dasatinib therapy|Sufficient tumor suitable for Immuno-Histochemistry (IHC) analysis was available from 20 patients||participants|||Number
769752|NCT00706641|Secondary|Post-Cystectomy Pathologic Stage|Tumor Node Metastasis (TNM) Staging. This system classifies tumors by size and extent of the primary tumor (T), involvement of regional lymph nodes (N), and the presence or absence of distant metastases (M) T0=No evidence of primary tumor, Tis=Carcinoma in situ, and T1, T2, T3, T4=Increasing size and/or local extension of the primary tumor, TX=Not assessed N0=No Regional lymph node metastases, N1, N2, N3=Increasing number or extent of regional lymph node involvement, NX=not assessed M0=No distant metastases, M1=Distant metastases present|Staged Post-Cystectomy and dasatinib treatment|||percentage of particpants||95% Confidence Interval|Number
769753|NCT00706641|Secondary|Pathologic Complete Response (pCR) Rate|Pathologic complete response (pCR) rate is defined as no residual evidence of muscle-invasive disease at cystectomy (< pT0).|24 months|23 participants completed treatment and underwent radical cystectomy.||participants|||Number
769754|NCT00706641|Secondary|Reduced pSFK Expression|pSFK levels were analyzed pre and post treatment|Baseline to post dasatinib therapy|Sufficient tumor suitable for Immuno-Histochemistry (IHC) analysis was available from 20 patients||participants|||Number
769755|NCT00706641|Secondary|Grade 3/4 Toxicities|Report grade 3/4 toxicities during treatment with dasatinib prior to radical cystectomy in patients with muscle invasive transitional cell carcinoma of the bladder.|Time of consent through 30 days after treatment discontinuation|24 patients received treatment, 1 patient ineligible due to small cell histology after starting dasatinib treatment and was not evaluable.||percentage of particpants|||Number
769756|NCT00706641|Primary|Feasibility|Feasibility for this trial is defined as at least 60% (>=14 of 23) of patients completing study therapy in the absence of Dose Limiting Toxicity (DLT)|From enrollment to completion of radical cystectomy|All patients who completed dasatinib||participants|||Number
769757|NCT00706654|Secondary|Percentage of Patients Achieving Remission|A patient was considered to have achieved remission if they had a score of ≤ 3 on each of the following PANSS items, maintained for a period of 6 months: Delusions (P1), unusual thought content (G9), hallucinatory behavior (P3), conceptual disorganization (P2), mannerisms/posturing (G5), blunted affect (N1), social withdrawal (N4), and lack of spontaneity (N6).|Baseline to the end of the study (Week 38)|Intent-to-treat population: All randomized patients.||Percentage of patients|||Number
769758|NCT00706654|Secondary|Percentage of Responders up to Week 38|A patient was considered to be a responder if all of the following criteria were met. 1) Outpatient status, 2) PANSS total score ≤ 80, 3) Lack of specific psychotic symptoms on the PANSS as measured by a score of ≤ 4 on each of the following items (possible scores of 1 to 7 for each item): Conceptual disorganization, suspiciousness, hallucinatory behavior, unusual thought content, and 4) Clinical Global Impression of Severity of Illness (CGI-S) ≤ 4 (moderately ill) and 5) CGI-SS ≤ 2 (mildly suicidal) on Part 1 and ≤ 5 (minimally worsened) on Part 2.|Baseline to the end of the study (Week 38)|Intent-to-treat population: All randomized patients.||Percentage of patients|||Number
769759|NCT00706654|Secondary|Time to Exacerbation of Psychotic Symptoms/Impending Relapse||Baseline to the end of the study (Week 38)|Intent-to-treat population: All randomized patients.||Days||95% Confidence Interval|Median
769760|NCT00706654|Primary|Percentage of Patients Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria by the End of Week 26|A patient had exacerbation of psychotic symptoms/impending relapse if they met any of the following 4 criteria. 1) Clinical Global Impression of Improvement score ≥ 5 and either an increase on any of the following Positive and Negative Syndrome Scale (PANSS) items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content) to a score > 4 with an increase of ≥ 2 on that item since randomization or an increase on any of the same PANSS items to a score > 4 and an increase of ≥ 4 on the same combined PANSS items since randomization, 2) Hospitalization due to worsening of psychotic symptoms, 3) Clinical Global Impression of Severity of Suicide (CGI-SS) score of 4 or 5 on Part 1 and/or 6 or 7 on Part 2, or 4) Violent behavior resulting in clinically significant self-injury, injury to another person, or property damage.|Baseline to Week 26|Intent-to-treat population: All randomized patients.||Percentage of patients|||Number
769761|NCT00706706|Secondary|One Year Survival Probability|One year survival probability was defined as the probability of survival at one year after the first dose of study treatment.|Baseline, Day 28 of Cycles 1, 2, 3, 4 and even cycles thereafter, every 2 months until death (up to 1 year)|Safety population included those participants who had taken at least one dose of the study drug.||Percent chance of survival||95% Confidence Interval|Number
769762|NCT00706706|Secondary|Overall Survival (OS)|Time in weeks from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Baseline, Day 28 of Cycles 1, 2, 3, 4 and even cycles thereafter until disease progression or every 2 months until death (up to 88 weeks)|Safety population included those participants who had taken at least one dose of the study drug.||Weeks||95% Confidence Interval|Median
769929|NCT00707863|Primary|17-item Hamilton Depression Rating Scale (HAM-D)|Standard scale for depression used in clinical trials. Range: 0 - 54. A score of 0-7 is considered to be normal. 8 - 13 mild depression. Scores of 20 or higher indicate moderate -severe depression.|Baseline and 8 weeks|||units on a scale||Standard Deviation|Mean
769763|NCT00706706|Secondary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.|Baseline, Day 28 of Cycles 1, 2, 3, 4 and even cycles thereafter until disease progression or every 2 months until death (up to 88 weeks)|Per protocol (PP) population included those participants who had the disease under study, measurable disease and an adequate baseline disease assessment and had taken at least one dose of the study drug.||Percentage of participants||95% Confidence Interval|Number
769764|NCT00706706|Primary|Progression-free Survival (PFS)|"Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Baseline, Day 28 of Cycles 1, 2, 3, 4 and even cycles thereafter until disease progression or every 2 months until death (up to 88 weeks)|Safety population included those participants who had taken at least one dose of the study drug.||Weeks||95% Confidence Interval|Median
769765|NCT00706719|Secondary|Follicle Stimulating Hormone (FSH) Levels|FSH levels were measured.|Baseline, Month 3, Month 6, Follow-Up (Month 7)|Subjects in Group A and B who completed the study. No analysis was performed for subjects in Group C because only 1 subject completed the study.||mIU/mL||Standard Deviation|Mean
769766|NCT00706719|Secondary|Luteinizing Hormone (LH) Levels|LH levels were measured.|Baseline, Month 3, Month 6, Follow-Up (Month 7)|Subjects in Group A and B who completed the study. No analysis was performed for subjects in Group C because only 1 subject completed the study.||mIU/mL||Standard Deviation|Mean
769767|NCT00706719|Primary|Semen Volume|Semen volume was measured.|Baseline, Month 3, Month 6, Follow-Up (Month 7)|Subjects in Group A and B who completed the study. No analysis was performed for subjects in Group C because only 1 subject completed the study.||mL||Standard Deviation|Mean
769768|NCT00706719|Primary|Motile Total Sperm Count|Motile total sperm count was measured.|Baseline, Month 3, Month 6, Follow-Up (Month 7)|Subjects in Group A and B who completed the study. No analysis was performed for subjects in Group C because only 1 subject completed the study.||millions sperm||Standard Deviation|Mean
769769|NCT00706719|Primary|Sperm Concentration|Total sperm concentration was measured.|Baseline, Month 3, Month 6, Follow-Up (Month 7)|Subjects in Group A and B who completed the study. No analysis was performed for subjects in Group C because only 1 subject completed the study.||millions sperm/mL||Standard Deviation|Mean
769770|NCT00706784|Primary|Serum Leuprolide Levels After EVA Ring Transvaginal Drug Delivery System Insertion||8 hours|||pg/ml||Standard Deviation|Mean
769771|NCT00706797|Secondary|Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS)|EQ-5D: subject rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.|Baseline, Week 12, Week 24, and Week 52|mITT; efficacy data not analyzed due to early termination of the study.||scores on scale||Standard Deviation|Mean
769772|NCT00706797|Secondary|Health Related Quality of Life: EuroQol-5D Health Index|EQ-5D is a self-administered questionnaire to assess health-related quality of life in 5 domains (mobility, self care, usual activities, pain or discomfort, and anxiety or depression). Scores from the 5 domains are used to calculate the Health State Profile Score as a single index value; range: 0.0 (death) to 1.0 (perfect health); higher scores indicate a better health state.|Baseline, Week 12, Week 24, and Week 52|mITT; efficacy data not analyzed due to early termination of the study.||scores on scale||Standard Deviation|Mean
769773|NCT00706797|Secondary|Percentage of Participants Achieving a Patient Acceptable Symptom State (PASS)|Percentage of participants reporting acceptable symptom state: acceptance to remain for the rest of their lives with the level of pain they had during the last 48 hours; and unacceptable symptom state: not able to remain for the rest of their lives with the level of pain they had during the last 48 hours.|Week 4, Week 12, Week 24, Week 40, Week 52|mITT; efficacy data not analyzed due to early termination of the study.||percentage of participants|||Number
769774|NCT00706797|Secondary|Percentage of Participants Achieving a Minimal Clinically Important Improvement (MCII)|Participants were asked how their pain had been during the last 48 hours compared to baseline. Participants that reported improvement assessed how important this improvement was to them; range: very important, moderately important, slightly important, or not at all important. Binary response options: 1=improved very important, or improved moderately important; 2=slightly important, not at all important, no change, or worse-more pain.|Week 12, Week 52|mITT; efficacy data not analyzed due to early termination of the study.||percentage of participants|||Number
769775|NCT00706797|Secondary|Change From Baseline in Mean Daily Dose of Corticosteroids to Manage Flare-ups Across the 52-week Treatment Period|Mean daily dose of corticosteroids to manage flare-ups (temporary increases in corticosteroid dose or use of intra-articular steroids) during treatment period. Daily dose of equivalent prednisone derived in mg/day: oral corticosteroids: 5 mg of prednisone = 5 mg of prednisolone = 25 mg of cortisone = 20 mg of hydrocortisone = 4 mg of methylprednisolone = 4 mg of triamcinolone = 2mg of paramethasone = 0.75 mg of betamethasone = 0.75 of dexamethasone = 0.3 of cortivazol.|Week 4, Week 12, Week 24, Week 40, Week 52|mITT; efficacy data not analyzed due to early termination of the study.||mg||Standard Deviation|Mean
769776|NCT00706797|Secondary|Percentage of Participants With American College of Rheumatology 90% (ACR90) Response|American College of Rheumatology 90% (ACR 90) response: responder = ≥ 90% improvement in tender joint count; ≥ 90% improvement in swollen joint count; and ≥ 90% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and erythrocyte sedimentation rate (ESR). Subjects withdrawing early were non-responders.|Week 12, Week 24, Week 52|mITT; efficacy data not analyzed due to early termination of the study.||percentage of participants|||Number
769777|NCT00706797|Secondary|Percentage of Participants With American College of Rheumatology 70% (ACR70) Response|American College of Rheumatology 70% (ACR70) response: responder = ≥ 70% improvement in tender joint count; ≥ 70% improvement in swollen joint count; and ≥ 70% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and erythrocyte sedimentation rate (ESR) . Subjects withdrawing early were non-responders.|Week 12, Week 24, Week 52|mITT; efficacy data not analyzed due to early termination of the study.||percentage of participants|||Number
769778|NCT00706797|Secondary|Percentage of Participants With American College of Rheumatology 50% (ACR50) Response|American College of Rheumatology 50% (ACR50) response: responder = ≥ 50% improvement in tender joint count; ≥ 50% improvement in swollen joint count; and ≥ 50% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and erythrocyte sedimentation rate (ESR). Subjects withdrawing early were non-responders.|Week 12, Week 24, Week 52|mITT; efficacy data not analyzed due to early termination of the study.||percentage of participants|||Number
769779|NCT00706797|Secondary|Percentage of Participants With American College of Rheumatology 20% (ACR20) Response|American College of Rheumatology 20% (ACR20) response: responder = ≥ 20% improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and erythrocyte sedimentation rate (ESR). Subjects withdrawing early were non-responders.|Week 12, Week 24, Week 52|mITT; efficacy data not analyzed due to early termination of the study.||percentage of participants|||Number
769780|NCT00706797|Secondary|Percentage of Participants Achieving Moderate or Good Response on European League Against Rheumatism (EULAR) Response Criteria|Response to treatment assessed by EULAR response criteria. Participants were characterized as good, moderate, or non-responders based on both Disease Activity Score (DAS) level attained and change in DAS. Good response defined as >1.2 improvement in DAS from Baseline and DAS attained during follow-up of ≤2.4. Non-responders = participants with improvement of ≤0.6 or participants with improvement of >0.6 but ≤1.2 and DAS attained during follow-up of >5.1. Remaining participants were classified as moderate. Scores of good and moderate were considered to have therapeutic response.|Week 12, Week 24, Week 52|mITT; efficacy data not analyzed due to early termination of the study.||percentage of participants|||Number
769781|NCT00706797|Secondary|Percentage of Participants Achieving a >0.6 Disease Activity Score (DAS)28 Response|Disease activity score based on 28 painful joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR) mm/hr, and participant’s assessment of general health (GH) using a visual analog scale (VAS); VAS range: 0 (very well) to 100 (extremely bad). DAS28 score calculated as 0.56 √ (28 painful joint count) + 0.28 √ (28 swollen joint count) + 0.70 (ln ESR mm/hr) + 0.014 GH; range 0 to 10. DAS28 score >5.10=higher disease activity; <3.20=low disease activity; <2.60=clinical remission. DAS28 response of >0.6 defined as decrease in DAS28 >0.6 (change in DAS28 < -0.6).|Week 12, Week 24, and Week 52|mITT; efficacy data not analyzed due to early termination of the study.||percentage of participants|||Number
769782|NCT00706797|Secondary|Percentage of Participants Achieving Low Disease Activity (DAS28 ≤3.20)|Disease activity score based on 28 painful joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR) mm/hr, and general health (GH) using a visual analog scale (VAS); VAS range: 0 (very well) to 100 (extremely bad). DAS28 score calculated as 0.56 √ (28 painful joint count) + 0.28 √ (28 swollen joint count) + 0.70 (ln ESR mm/hr) + 0.014 GH; range 0 to 10. DAS28 score >5.10=higher disease activity; <3.20=low disease activity; <2.60=clinical remission.|Week 12, Week 24, and Week 52|mITT; efficacy data not analyzed due to early termination of the study.||percentage of participants|||Number
769783|NCT00706797|Secondary|Percentage of Participants Achieving Remission (DAS28 <2.60)|Disease activity score based on 28 painful joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR) mm/hr, and general health (GH) using a visual analog scale (VAS); VAS range: 0 (very well) to 100 (extremely bad). DAS28 score calculated as 0.56 √ (28 painful joint count) + 0.28 √ (28 swollen joint count) + 0.70 (ln ESR mm/hr) + 0.014 GH; range 0 to 10. DAS28 score >5.10=higher disease activity; <3.20=low disease activity; <2.60=clinical remission.|Week 12, Week 24, and Week 52|mITT; efficacy data not analyzed due to early termination of the study.||percentage of participants|||Number
769784|NCT00706797|Secondary|Percentage of Participants Achieving >1.2 Improvement in Disease Activity Score Based on a 28-joint Count (DAS28)|Disease activity score based on 28 painful joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR) in millimeters per hour (mm/hr), and general health (GH) using Visual Analog Scale (VAS); range 0 (very well) to 100 (extremely bad). DAS28 score calculated as 0.56 square root (√) (28 painful joint count) + 0.28 √ (28 swollen joint count) + 0.70 (ln ESR mm/hr) + 0.014 GH; range 0 to 10. DAS28 score >5.1=higher disease activity; <3.2=low disease activity; <2.6=clinical remission. Achievement of >1.2 improvement defined as decrease in DAS28 >1.2 (change in DAS28 < -1.2).|Baseline, Week 12, Week 24, and Week 52|mITT; efficacy data not analyzed due to early termination of the study.||percentage of participants|||Number
769785|NCT00706797|Secondary|Percentage of Participants Showing no Radiographic Progression (TSS Change <0.5) at Week 52|Radiographic non-progression determined based on TSS change <0.5 using the dichotomous response Yes / No. The modified TSS range is from 0 (no damage) to 448 (bad joint status). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.|Baseline, Week 52, Last observation carried forward (LOCF)|mITT; efficacy data not analyzed due to early termination of the study.||percentage of participants||95% Confidence Interval|Number
769786|NCT00706797|Secondary|Change From Baseline in Joint Space Narrowing at Week 52|Joint space narrowing score (a component of the modified TSS) is a measure of change in joint health. Joint space narrowing score range is 0 (no narrowing) to 168 (high narrowing). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.|Baseline, Week 52|mITT; efficacy data not analyzed due to early termination of the study.||scores on a scale||Standard Deviation|Mean
769788|NCT00706797|Primary|Change From Baseline in Modified Total Sharp Score (TSS) at Week 52|Modified TSS is a measure of change in joint health. TSS is defined as joint space narrowing score (range 0 [no narrowing] to 168 [high narrowing]) plus (+) erosion score (range is from 0 [no erosion] to 280 [high erosion]). The modified TSS range is from 0 (no damage) to 448 (bad joint status). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.|Baseline, Week 52|Modified intent-to-treat (mITT) population including all participants with an erosion at randomization confirmed by the blinded expert assessor, received at least 1 dose of subject treatment, and had data for randomization and 1 post randomization X-ray. Efficacy data not analyzed due to early termination of the study.||scores on a scale||Standard Deviation|Mean
769789|NCT00706810|Secondary|Median Progression-free Survival Rates of the Treatment Population.|Response and progression will be evaluated in this study using measurements from the MRI/CT scans. Measurements will be made of the image slice with the largest cross sectional area. Two orthogonal measures will be made to determine maximal AP and lateral dimensions. Progression of disease will be defined as a greater than 25% increase of largest cross sectional area by two orthogonal measurements, taking as reference the smallest sum recorded since the treatment started or the appearance of one or more new lesions.|31 months|||months||Full Range|Median
769790|NCT00706810|Primary|Number of Participants Experiencing Serious Adverse Events Including But Not Limited to Hospitalizations, Deaths Related to Treatment, or Other Incapacitating Conditions.|Adverse Events assessed in accordance with CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0.|two years|||participants|||Number
769791|NCT00706823|Secondary|Number of Attempts|The number of attempts taken to place the device|Before intubation|||participants|||Number
769792|NCT00706823|Secondary|Number of Participants With Successful Gastric Drainage Tube Placement as Assessed by Fiberoptic Scope Visualization|When the fiberoptic scope was placed in the gastirc drain tube of the i-gel, if the esophageal mucosa was visible and the stomach was readily accessible, then placement was considered succussful.|after intubation|Only the -gel has a gastric drainage tube--the uLMA does not. Thus, only those receiving the i-gel were assessed for this measure.||participants|||Number
769793|NCT00706823|Primary|Leak Pressure|After successful placement, airway leak pressure was assessed by closing the circuit to atmosphere and allowing fresh gas flow to build airway pressure. The pressure at which an audible leak was heard was recorded; airway pressure was not permitted to exceed 40 cm H2O.|duration of intubation|||cm of H2O||Standard Deviation|Mean
769794|NCT00706823|Secondary|Number of Participants With Oropharyngeal Discomfort|Oropharyngeal discomfort was assessed. including sore throat, hoarseness, and dysphagia.|post operative, immediately and 24 hrs after intubation|||participants|||Number
769795|NCT00706823|Secondary|Level of Difficulty for Intubation|Ease of SGA insertion and intubation was subjectively assessed by the operator on a scale from 1 to 5 (1 = very easy, 2 = easy, 3 = neutral, 4 = difficult, 5 = very difficult).|duration of intubation|||participants|||Number
769796|NCT00706823|Primary|Time Required for Intubation|The total time to intubation was measured from the beginning of supraglottic airway device (SGA) insertion to successful endotracheal tube intubation, verified by detection of CO2 on the capnogram (anesthesia machine).|duration of intubation|||seconds||Standard Deviation|Mean
769797|NCT00706836|Secondary|To Evaluate the Effects of an Anxiolytic Drug Versus Placebo on Eye Blink Startle Response at Rest and During Emotional Stimuli (Anxiety Potentiated Startle, APS) as Well as on Clinical Scales.||Week 1, 2, 3||||||
769798|NCT00706836|Primary|Effect of Pregabalin (Two Doses) Versus Placebo|Region of Interest (ROI) analysis of contrast of doses (high and low) of pregabalin vs placebo on brain activity at rest and during emotional stimuli using fMRI and clinical scales.|Week 1, 2, 3 (Cross-over Design)|Cross-over design, complete data available for all participants. Total number of participants in study is 16; all subjects received all 3 arms of treatment in randomized order.||% signal change L amygdala + anticipn||Standard Error|Mean
769799|NCT00706849|Other Pre-specified|High-Density Lipoprotein Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set||mg/dL||Inter-Quartile Range|Median
769800|NCT00706849|Other Pre-specified|Percent Change From Baseline in High-Density Lipoprotein Cholesterol at the Primary Efficacy Time Point|High-density lipoprotein cholesterol (HDL-C) was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set||percentage of baseline||Inter-Quartile Range|Median
769801|NCT00706849|Other Pre-specified|Apolipoprotein A1 at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set||mg/dL||Standard Deviation|Mean
769802|NCT00706849|Other Pre-specified|Percent Change From Baseline in Apolipoprotein A1 at the Primary Efficacy Time Point|Apolipoprotein A1 was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set||percentage of baseline||Standard Deviation|Mean
769803|NCT00706849|Other Pre-specified|Ratio of LDL Cholesterol to HDL Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set||ratio||Inter-Quartile Range|Median
775454|NCT00756977|Primary|Efficacy - Preparation Quality Using a 4 Point Scale|"Percentage of patients with a successful preparation (cleaning rated as Good or Excellent"|2-day|||percentage of participants||95% Confidence Interval|Number
769804|NCT00706849|Other Pre-specified|Percent Change From Baseline in the Ratio of LDL Cholesterol to HDL Cholesterol at the Primary Efficacy Time Point|The ratio of low-density lipoprotein (LDL) cholesterol to high-density lipoprotein (HDL) cholesterol was measured at Baseline and the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set||percentage of baseline||Inter-Quartile Range|Median
769805|NCT00706849|Other Pre-specified|Very Low Density Lipoprotein at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set||mg/dL||Inter-Quartile Range|Median
769806|NCT00706849|Other Pre-specified|Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol at the Primary Efficacy Time Point|Very low density lipoprotein (VLDL) cholesterol was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set||percentage of baseline||Inter-Quartile Range|Median
769807|NCT00706849|Other Pre-specified|Lipoprotein (a) at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set||mg/dL||Inter-Quartile Range|Median
769808|NCT00706849|Other Pre-specified|Percent Change From Baseline in Lipoprotein (a) at the Primary Efficacy Time Point|Lipoprotein (a) was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set||percentage of baseline||Inter-Quartile Range|Median
769809|NCT00706849|Other Pre-specified|Triglycerides at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set||mg/dL||Inter-Quartile Range|Median
769810|NCT00706849|Other Pre-specified|Percent Change From Baseline in Triglycerides at the Primary Efficacy Time Point|Triglycerides were measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set||percentage of baseline||Inter-Quartile Range|Median
769811|NCT00706849|Secondary|Non-High-Density Lipoprotein Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set||mg/dL||Standard Deviation|Mean
769812|NCT00706849|Secondary|Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol at the Primary Efficacy Time Point|Non-high-density lipoprotein cholesterol was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set||percentage of baseline||Standard Deviation|Mean
769813|NCT00706849|Secondary|Total Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set||mg/dL||Standard Deviation|Mean
769814|NCT00706849|Secondary|Percent Change From Baseline in Total Cholesterol at the Primary Efficacy Time Point|Total cholesterol was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set||percentage of baseline||Standard Deviation|Mean
769815|NCT00706849|Secondary|Apolipoprotein B at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set||mg/dL||Standard Deviation|Mean
769816|NCT00706849|Secondary|Percent Change From Baseline in Apolipoprotein B at the Primary Efficacy Time Point|Apolipoprotein B was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set||percentage of baseline||Standard Deviation|Mean
769817|NCT00706849|Primary|LDL Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set||mg/dL||Standard Deviation|Mean
769818|NCT00706849|Primary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at the Primary Efficacy Time Point|LDL cholesterol was measured in mg/dL. Samples were taken following an overnight fast. For patients with triglycerides <400 mg/dL, LDL-C was obtained using Friedewald’s calculation; and for patients with triglycerides ≥400 mg/dL, LDL-C was directly measured by the central laboratory using ultracentrifugation. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|The Full Analysis Set, which consisted of all randomized patients who received at least 1 injection of study drug (mipomersen or placebo) and with a valid baseline and at least 1 post-baseline LDL-C measurement.||percentage of Baseline||Standard Deviation|Mean
769819|NCT00706901|Secondary|Number of Illicit Drug Use Days in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days|Number of illicit drug use days is the number of days that that participant self-reported having used illicit drug (e.g., cocaine, crack, marijuana, opiates, sedatives, hallucinogens) during the specified follow up period on the Time Line Follow Back (Sobell & Sobell, 1992).|One and three-months post intervention in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days|Intent to treat population (at least one GMI session attended)||Days of drug use||Standard Deviation|Mean
769820|NCT00706901|Primary|Treatment Attendance at 12-step or Mutual Self-help Sessions in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days|Number of self-reported 12-step (number of self-help alcoholics anonymous or narcotics anonymous [AA/NA]) sessions, including days of consulting with a 12-step sponsor for help with a substance use problem based on the Time Line Follow-Back (Sobell & Sobell, 1992).|One and three-months post intervention in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days|Intent to treat population (at least one GMI session attended)||Number of 12-step sessions attended||Standard Deviation|Mean
769821|NCT00706901|Primary|Treatment Utilization in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days|Treatment utilization is the number of treatment attendance sessions based on objective CPRS medical records, including number of all VA substance abuse outpatient, other mental health (e.g., PTSD, depression), and other substance abuse treatment sessions.|One and three-months post intervention in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days|Intent to treat population (at least one GMI session attended)||Number of treatment sessions||Standard Deviation|Mean
769822|NCT00706901|Primary|Standard Number of Alcohol Drinks in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days|Standard drinks, or SECs, is the number of drinks that the participant self-reported consuming (as measured by 0.5 oz ethanol alcohol per beverage) during the specified follow up period on the Time Line Follow Back (Sobell & Sobell, 1992).|One and three-months post intervention in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days|Intent to treat population (at least one GMI session attended)||Standard alcohol drinks||Standard Deviation|Mean
769823|NCT00706901|Primary|Number of Alcohol Binge Drinking Days in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days|Number of alcohol binge drinking days is the number of days that that participant self-reported having at least 4 standard alcohol beverages on one occasion (for women) and at least 5 standard alcohol beverages on one occasion (for men) during the specified follow up period on the Time Line Follow Back (Sobell & Sobell, 1992).|One and three-months post intervention in the previous 30 (one month follow up) and 60 (three month follow up) days|Intent to treat population (at least one GMI session attended)||Days of binge drinking||Standard Deviation|Mean
769824|NCT00706901|Primary|Number of Alcohol Drinking Days in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days|Number of alcohol drinking days is the number of days that that participant self-reported having at least 1 standard alcohol beverage during the specified follow up period on the Time Line Follow Back (Sobell & Sobell, 1992).|One month follow-up and three month follow up in the previous 30 (one month follow up) and 60 (three month follow up) days|Intent to treat population (at least one GMI session attended)||Days Using Alcohol||Standard Deviation|Mean
769825|NCT00706914|Other Pre-specified|Change From Baseline in Normalized Area Under the Curve (0-3 hr) of Forced Expiratory Volume in One Second (FEV1)|FEV1 values obtained at 30, 60, 120, and 180 minutes after the morning study drug dose|Week 4 of treatment|Includes the number of patients in the randomized population with available analysis value at both baseline and a specific time point. Randomized population defined as all patients in the screened population who were randomized to a treatment group in the study.||Liters||95% Confidence Interval|Mean
769826|NCT00706914|Other Pre-specified|Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1)||Week 4 of treatment|Includes the number of patients in the randomized population with available analysis value at both baseline and a specific time point. Randomized population defined as all patients in the screened population who were randomized to a treatment group in the study.||Liters||95% Confidence Interval|Mean
769827|NCT00706914|Other Pre-specified|Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1)|The trough value for each pulmonary function parameter was defined as the mean of the two greatest readings assessed 23 hours and 24 hours following the administration of the morning dose of the previous day|Week 4 of treatment|Includes the number of patients in the randomized population with available analysis value at both baseline and a specific time point. Randomized population defined as all patients in the screened population who were randomized to a treatment group in the study.||Liters||95% Confidence Interval|Mean
769828|NCT00706914|Primary|Change From Baseline in Weekly Average Daily (24 Hour) Sputum Volume Scores|Sputum Volume Score Scale: 0 = None; 1 = The amount of one teaspoon; 2 = The amount of one tablespoon; 3 = More than one tablespoon|Week 4 of treatment|Includes the number of patients in the randomized population with available analysis value at both baseline and a specific time point. Randomized population defined as all patients in the screened population who were randomized to a treatment group in the study.||Units on a scale||95% Confidence Interval|Mean
769862|NCT00707057|Secondary|"Percentage of Subjects Achieving Meaningful Relief as Indicated by the Time Recorded on the Second Stopwatch Following First Perceptible Relief"|"Percentage(%) of subjects with confirmed first perceptible relief and meaningful relief after dose 1. Subjects that achieved both first perceptible relief and meaningful relief within the time allotted. The assigned censored time for No Pain Relief is 240 minutes. Meaningful relief is a subjective definition, based on each subject's determination of pain"|Within 4 hours post Dose 1|Intention to treat (ITT)||Percent of participants||95% Confidence Interval|Number
769829|NCT00706914|Primary|Change From Baseline in Weekly Average Nocturnal Symptom Scores|Nocturnal Symptom Score Scale: 0 = None; 1 = Symptoms causing early awakening or awakening once during the night; 2 = Symptoms causing early awakening or awakening two or more times during the night; 3 = Symptoms causing awakening for most time during the night, 4 = Symptoms which were so severe that I could not sleep at all|Week 4 of treatment|Includes the number of patients in the randomized population with available analysis value at both baseline and a specific time point. Randomized population defined as all patients in the screened population who were randomized to a treatment group in the study.||Units on a scale||95% Confidence Interval|Mean
769830|NCT00706966|Secondary|Testosterone Over Time||Baseline, 1, 3, and 6 months|Because one participant withdrew from the study prior to 6-months, n=9 at 6 months.||ng/dL||Standard Deviation|Mean
769831|NCT00706966|Secondary|Dihydrotestosterone (DHT) Over Time||Baseline, 1, 3, and 6 months|Because one participant withdrew from the study prior to 6-months, n=9 at 6 months.||ng/dL||Standard Deviation|Mean
769832|NCT00706966|Secondary|Total PSA Over Time||Baseline, 1, 3, and 6 months|Because one participant withdrew from the study prior to 6-months, n=9 for the 6-month Mean(SD) levels.||ng/mL||Standard Deviation|Mean
769833|NCT00706966|Secondary|Health-Related Quality of Life (HRQL) Indices Over Time - SQLI|The Spitzer Quality of Life Index (SQLI) is a validated five-item questionnaire evaluating global HRQL. Activity, daily living, health, support of family and friends, and outlook are each rated on a 3-point scale (0 to 2), with total score ranging from 0-10, with lower score indicating poorer HRQL.|Baseline, 1, 3, and 6 months|One participant withdrew from the study prior to 6 months; thus, n=9 at 6 months.||units on a scale||Standard Deviation|Mean
769834|NCT00706966|Secondary|Health-Related Quality of Life (HRQL) Indices Over Time - FACE|Functional Alterations due to Changes in Elimination (FACE) is a 14-item questionnaire designed to evaluate the effects of changes in urinary and bowel elimination on daily functioning. It is scored out of 56, with higher scores reflecting poorer HRQL.|Baseline, 1, 3, and 6 months|One participant withdrew from the study prior to the 6 month timepoint; thus n=9 at 6 months.||units on a scale||Standard Deviation|Mean
769835|NCT00706966|Secondary|Symptom Indices Over Time - IIEF-5|The International Index of Erectile Function (IIEF-5) is an abridged five-item version of the original IIEF 15-item questionnaire designed to evaluate erectile function, based on a definition arrived at by the National Institutes of Health Consensus Panel. Each of 5 questions about erectile function over the past 6 months is scored by the patient from 1 (severe dysfunction) to 5 (little or no dysfunction). The IIEF-5 is scored from 5 to 25, with lower scores indicating erectile dysfunction: 22-25 = No erectile dysfunction; 17-21 = Mild erectile dysfunction; 12-16 = Mild to moderate erectile dysfunction; 8-11 = Moderate erectile dysfunction; 5-7 = Severe erectile dysfunction|Baseline, 1, 3, and 6 months|One participant withdrew from the study prior to the 6 month timepoint; thus n=9 at 6 months.||units on a scale||Standard Deviation|Mean
769836|NCT00706966|Secondary|Symptom Indices Over Time - IPSS|IPSS (The International Prostate Symptom Score) is a symptom index based on seven questions concerning urinary symptoms (1 Incomplete emptying, 2 Frequency, 3 Intermittency, 4 Urgency, 5 Weak Stream, 6 Straining, 7 Nocturia) for which the patient chooses one out of six answers indicating increasing severity of the particular symptom, ranging from 0 (Not at all) to 5(Almost always). The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). Mild (symptom score less than of equal to 7); Moderate (symptom score range 8-19); Severe (symptom score range 20-35).|Baseline, 1, 3, and 6 months|Because one participant withdrew from the study prior to 6-months, n=9 at 6 months.||units on a scale||Standard Deviation|Mean
769837|NCT00706966|Secondary|Adverse Events Indicative of Safety of Dutasteride|Toxicities from Dutasteride were recorded at each study visit and assessed by NCI-CTCAE v3.0.|Baseline, 1, 3, and 6 months|||adverse events|||Number
769838|NCT00706966|Primary|Change in Extent of Cancer|Proportion of voxels consistent with prostate cancer as measured by magnetic resonance spectroscopy imaging (MRSI). MRSI spectra were examined and scored as healthy or cancerous. The change in cancerous volumes over time was evaluated. Because a significant decrease in citrate and polyamines on MRSI spectra was noted at 1 month compared with baseline, healthy tissue appeared to be more like cancer and thus created a false impression that the cancer had grown after 1 month. To reduce this bias, primary comparisons were made between the 1-month and 6-month scans.|1 month, 6 months|One participant withdrew from the study||participants|||Number
769839|NCT00706979|Secondary|Abstinence From Cigarette Smoking, Where Abstinence is Defined as Self-report of Not Smoking at All for 7 Consecutive Days||At 6-month follow-up|All analyses were based on intent-to-treat approach; participants with missing data were assumed to have not made any quit attempts or quit.||participants|||Number
769840|NCT00706979|Primary|A 24 Hour Serious Quit Attempt in Which the Participant Intends to Permanently Stop Smoking|Serious quit attempt of >=24hrs, which fits the CDC’s definition of a quit attempt.|From study enrollment through six month follow-up|All analyses were based on intent-to-treat approach; participants with missing data were assumed to have not made any quit attempts or quit.||participants|||Number
769841|NCT00706979|Secondary|Abstinence From Cigarette Smoking, Where Abstinence is Defined as Self-report of Not Smoking at All for 7 Consecutive Days||At any point during the study|All analyses were based on intent-to-treat approach; participants with missing data were assumed to have not made any quit attempts or quit.||participants|||Number
769842|NCT00706979|Primary|A Serious Quit Attempt in Which the Participant Intends to Permanently Stop Smoking|The primary outcome was an attempt to quit smoking for good. To distinguish from a PQA, we specifically asked participants if they tried to quit smoking with the intent of quitting for good. Quit attempts were defined as any self-defined attempt to quit for good.|From study enrollment through six month follow-up|All analyses were based on intent-to-treat approach; participants with missing data were assumed to have not made any quit attempts or quit.||participants|||Number
769843|NCT00706992|Primary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|4 years|||Participants|||Number
769863|NCT00707057|Secondary|Percentage (%) of Subjects With Confirmed First Perceptible Relief Within 1 Hour of Dose 1|"Percentage (percentage of total) of subjects with first perceptible relief within 1 hour of Dose 1. The assigned censored time for No Pain Relief was 240 minutes."|Within 1 hour of Dose 1|Intention to treat (ITT)||Percent of participants||95% Confidence Interval|Number
769844|NCT00706992|Primary|Percentage of Participants With Immunologic Response|Percentage of participants with an immunologic response of >20 spots/100,000 cells measured by IFN gamma secretion using enzyme linked immunosorbent spot (ELISPOT) assay. This was done using ELISPOT assay which measures immune response at the single cell level.|9/24/08-10/9/12|Arms 1-6 were evaluated in patients who received F5 cells. Arm 7 was not included in the evaluation because the participants did not receive F5 cells.The immunological response was measured for the total percentage of pts whom specimen was available for analysis. This was not captured per Arm. No statistically significant responses were observed.||Percentage of participants|||Number
769845|NCT00707031|Other Pre-specified|Quality of Life: Change From Baseline in Patient's Satisfaction to Treatment (PAGI-QOL) at Week 24|PAGI-QOL: a 30–item self-administered questionnaire to measure health related QOL of patients with upper gastrointestinal disorders during past 2 weeks. Consists of 5 sub-scales. Each item rated on a 0-5 point Likert scale (0 [none of the time] to 5 [all the time]). Sub-scale score calculated by dividing sum of all items of subscale by number of items in the sub-scale. Total score calculated by taking mean of sub-scale scores. Sub-scale score and total score ranges from 0=none of the time (lowest score) to 5=all of the time (highest score) with lower scores indicating better QOL. The on-treatment period for this variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 11 (Week 24) or Day 169 if Visit 11 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline PAGI-QOL assessment during on-treatment period.||units on a scale||Standard Error|Least Squares Mean
769846|NCT00707031|Other Pre-specified|Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia|Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from hypoglycemia in which the patient required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.|First dose of study drug up to 3 days after the last dose administration, for up to 116 weeks|Safety population included all randomized patients who received at least 1 dose of study drug, regardless of the amount of treatment administered.||participants|||Number
769847|NCT00707031|Other Pre-specified|Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 11 (Week 24) or Day 169 if Visit 11 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.||percentage of participants|||Number
769848|NCT00707031|Secondary|Percentage of Patients Requiring Rescue Therapy During Main 24-Week Period|Routine fasting self-monitored plasma glucose (SMPG) and central laboratory FPG (and HbA1c after week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after week 12) were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG >270 milligram/deciliter (mg/dL) (15.0 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 24: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c > 8.5%. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline up to Week 24|mITT population.||percentage of participants|||Number
769849|NCT00707031|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 11 (Week 24) or Day 169 if Visit 11 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.||percentage of participants|||Number
769850|NCT00707031|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 11 (Week 24) or Day 169 if Visit 11 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.||percentage of participants|||Number
769851|NCT00707031|Secondary|Change From Baseline in Body Weight at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 11 (Week 24) or Day 169 if Visit 11 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.||kilogram||Standard Error|Least Squares Mean
769899|NCT00707447|Primary|Weight Change|Mean weight change (in kg) after 12 months|12 month|Intention to treat analysis (LOCF) and per protocol analysis for primary outcome and per protocol analysis for secondary outcome measures||kg||Standard Deviation|Mean
769900|NCT00707486|Secondary|Incidence of Post Surgical Sequelae||1 week post surgery|||Percent of Participants|||Number
769852|NCT00707031|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after the last dose of study drug, on or before Visit 11 (Week 24) or Day 169 if Visit 11 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using last observation carried forward (LOCF). Here, number of patients analyzed = patients with baseline and at least 1 post-baseline FPG assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
769853|NCT00707031|Primary|Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|Absolute Change = HbA1c value at Week 24 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 11 (Week 24) or Day 169 if Visit 11 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population:all randomized patients who received at least 1 dose;had baseline,at least 1 post-baseline efficacy assessment, irrespective of compliance with study protocol/procedures. Last observation carried forward used. Number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.||percentage of hemoglobin||Standard Error|Least Squares Mean
769854|NCT00707057|Secondary|Global Evaluation, Maximum Relief, and Overall Relief for Dose 4|"Global evaluation, maximum relief, and overall relief scores for dose 4 were summarized with descriptive statistics. The subject was to provide a description for the Global Evaluation, maximum relief and overall relief of Dose 4 of study medication on an 11 point PI-NRS: Global Evaluation: rate the study medication as a pain-reliever; Maximum Pain Relief: maximum pain relief received from the last dose; Overall Pain Relief: overall quantity of pain relief received from the last dose. The range went from 0 (Very poor or No relief) to 10 (Excellent or Complete relief)."|At 48 hours or at time of rescue between 36 and 48 hours.|Intention to treat (ITT)||Units on a scale||Standard Deviation|Mean
769855|NCT00707057|Secondary|Global Evaluation, Maximum Relief, and Overall Relief for Dose 3|"Global evaluation, maximum relief, and overall relief scores for dose 3 were summarized with descriptive statistics. The subject was to provide a description for the Global Evaluation, maximum relief and overall relief of Dose 3 of study medication on an 11 point PI-NRS: Global Evaluation: rate the study medication as a pain-reliever; Maximum Pain Relief: maximum pain relief received from the last dose; Overall Pain Relief: overall quantity of pain relief received from the last dose. The range went from 0 (Very poor or No relief) to 10 (Excellent or Complete relief)."|At 36 hours or at time rescue between 24 and 36 hours|Intention to Treat (ITT)||Units on a scale||Standard Deviation|Mean
769856|NCT00707057|Secondary|Global Evaluation, Maximum Relief, and Overall Relief for Dose 2|"Global evaluation, maximum relief, and overall relief scores for dose 2 were summarized with descriptive statistics. The subject was to provide a description for the Global Evaluation, maximum relief and overall relief of Dose 2 of study medication on an 11 point PI-NRS: Global Evaluation: rate the study medication as a pain-reliever; Maximum Pain Relief: maximum pain relief received from the last dose; Overall Pain Relief: overall quantity of pain relief received from the last dose. The range went from 0 (Very poor or No relief) to 10 (Excellent or Complete relief)."|At 24 hours or at time of rescue between 12 and 24 hours|Intention to treat (ITT)||Units on a scale||Standard Deviation|Mean
769857|NCT00707057|Secondary|Global Evaluation for Dose 1|"Global evaluation for dose 1, either at the time of rescue or at dose 2 (hour 12), whichever came first were summarized. At the 12-hour time point but before Dose 2, or within 1 minute of rescue medication use (if it occurred before hour 12), the subject was to provide a Global Evaluation of Dose 1 of study medication on an 11 point PI-NRS in response to the following command:
“Select the number that best describes how you would rate this medication as a pain-reliever (select one number only).” The range went from 0 (Very poor) to 10 (Excellent)."|At 12 hours after Dose 1 or at time of rescue|Intention to treat (ITT)||Units on a scale||Standard Deviation|Mean
769858|NCT00707057|Secondary|Pain Relief and PID Scores at Individual Time Points for Dose 1|Pain relief and pain intensity difference (PID) scores at individual time points were summarized by descriptive statistics. The PID at each time point prior to dose 2 was derived by subtracting the pain intensity from the baseline pain intensity, so that a higher value was indicative of a greater improvement. Range of possible scores could be from 0 (no improvement) to 5 (greatest possible improvement)|24, 36, 48 hours after taking Dose 1|Intention to treat (ITT)||Units on a scale||Standard Deviation|Mean
769859|NCT00707057|Secondary|Percentage of Participants Who Require Rescue Medication at or Prior to Hour 8, Hour 10, and Hour 12 After Taking Dose 1|Percentage of participants who require rescue medication (Lortab) at or prior to hour 8, hour 10 and hour 12 were reported and 95% confidence intervals for the corresponding parameters were calculated.|0-12 hours after taking Dose 1|Intention to treat (ITT)||Percentage of participants||95% Confidence Interval|Least Squares Mean
769860|NCT00707057|Secondary|Duration of Relief After Dose 1|Duration of relief was defined as the time to treatment failure (i.e.,taking rescue medication, or withdrawing due to lack of efficacy) up to the 12-hour time point. For those withdrawing from the study due to lack of efficacy prior to taking dose 2 or rescue medication, time to treatment failure was the time from dose 1 to the last assesment time. For those discontinuing from the study for any other reason, the time to treatment failure was censored at the last assessment time.|Time to rescue or time of Dose 2 (up to 12 hours following dose 1)|Intention to treat (ITT)||Minutes||Full Range|Median
769861|NCT00707057|Secondary|Analgesic Efficacy for the 0-12, 0-4, 4-8, and 4-12 Hour Dosing Intervals After Dose 1 Using Total Pain Relief (TOTPAR) and Sum of Pain Intensity Difference(SPID)|The Pain Intensity Difference (PID) at each time point was derived by subtracting the pain intensity from baseline pain intensity, so that a higher value was indicative of a greater improvement. Time weighted SPID for each specified interval (scale ranges from 0 to 10; 0=no pain relief and 10= complete pain relief) was derived by first multiplying each PID score by the time from the previous time point, and adding them together for each scheduled time point within the time interval (e.g., 4-12 hours in case of SPID 4-12). Time weighted TOTPAR for each specified interval was similarly derived.|0-12 hours after Dose 1|Intention to treat (ITT)||Time weighted units on a scale||Standard Deviation|Mean
769864|NCT00707057|Secondary|"Time to Confirmed Meaningful Relief"|"When the subject was administered study medication at Time 0, the Study Coordinator started 2 stopwatches. To determine the exact moment that the subject began to notice pain relief, the subject was instructed to stop the stopwatch when initial relief was observed and again when meaningful relief was achieved. Time to confirmed meaningful relief was achieved if both stopwatches were stopped within the 4 hour observation period, when both initial and meaningful relief were observed. Meaningful relief is a subjective definition, based on each subjects determination of pain."|Within 4 hours post Dose 1|Intention to treat (ITT)||Minutes||Full Range|Median
769865|NCT00707057|Secondary|"Time to Confirmed First Perceptible Relief"|"When the subject was administered study medication at Time 0, the Study Coordinator started 2 stopwatches. In an effort to determine the exact moment that the subject began to obtain noticeable pain relief, the subject was instructed to stop the stopwatch when initial relief was observed and again when meaningful relief was achieved. Time to confirmed first perceptible relief was defined as the time to first perceptible relief, provided that the subject also later stopped the second stopwatch indicating meaningful relief. The assigned censored time for No Pain Relief is 240 minutes."|Within 4 hours post Dose 1|Intention to treat (ITT)||Minutes||Full Range|Median
769866|NCT00707057|Primary|Durability of Effect as Measured by the Number of Subjects Achieving Meaningful Improvement in Pain Intensity Difference (PID) From Baseline at All Three Assessment Periods of 24, 36, and 48 Hours|Response rate measured the durability of effect and was measured by the number of subjects achieving a reduction of at least 2 points (greater than or equal to 20%) from baseline on the 11-point Pain Intensity Numerical Rating Scale (PI-NRS) at all 3 assessment periods of 24, 36 and 48 hours. The scale went from 0 (no pain) to 10 (Worst possible pain). Subjects were asked to select the number that best describes how much pain they had at the time of observation.|24, 36, and 48 hours|Intention to treat (ITT)||participants|||Number
769867|NCT00707057|Primary|Analgesic Efficacy, as Measured by the Sum of Pain Intensity Differences (SPID) Scale|"Analgesic efficacy for the 8-12 hour measurement interval after dose 1 using Sum of Pain Intensity Differences (SPID).
An 11-point Pain Intensity Numerical Rating Scale (PI-NRS) was used to record pain intensity at baseline and 8, 9, 10, 11, 12 hours after dose 1. The scale went from 0 (no pain) to 10 (Worst possible pain). The outcome measure is based a mean of the sum of each of the five time points evaluated. The total time scale ranges from 0 to 50. Subjects were asked to select the number that best describes how much pain they had at the time of observation."|from baseline to 12 hours after dose 1|Intention to treat (ITT)||Units on a scale||Standard Deviation|Mean
769868|NCT00707161|Primary|Response Rate of Melanoma Lesions|Response rate of melanoma lesions was measured after treated with the trial agent.|2005-2010|Study terminated. Analysis not conducted.|||||
769869|NCT00707174|Primary|The Absence of Lentigo Maligna (LM) at the Time of Staged Excisions in Participants|Negative histologic margins for the imiquimod plus tazarotene group compared to the imiquimod only group.|24 months|All evaluable patients from both groups were compared||participants|||Number
769870|NCT00707239|Other Pre-specified|Duration of Intravenous Antibiotic Treatment, Hospital and Intensive Care Unit (ICU) Stay||Baseline up to Day 44 (30 days after LDOT)|mITT population included all randomized participants who received at least 1 dose of study medication. Here, ‘n’ signifies those participants who were evaluable for intravenous antibiotic treatment, hospital or ICU stay for each reporting group respectively.||days||Full Range|Median
769871|NCT00707239|Other Pre-specified|Time to Reach Half of the Maximum Observed Plasma Concentration and Time to Normalization of Concentrations (Tnorm) of Procalcitonin||Baseline up to Day 6|Data was not analyzed because there was no apparent change in procalcitonin concentration over time.||hr||Full Range|Median
769872|NCT00707239|Other Pre-specified|Maximum Observed Plasma Concentration of Procalcitonin (Cmaxpd) and Predicted Procalcitonin Plasma Concentration at 24 Hours (Cpd,24) and 48 Hours (Cpd,48)||Baseline up to Day 6|mITT population included all randomized participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||ng/mL||Standard Deviation|Mean
769873|NCT00707239|Other Pre-specified|Correlation of AUC(0-24) to Minimum Inhibitory Concentration (MIC) Ratio (AUC [0-24]/MIC) of Tigecycline With Microbiological Outcome|Microbiological response:Eradication=baseline isolate not present in repeat culture from original infection site;Presumed Eradication=clinical response of cure precluded availability of specimen for culture;Persistence=baseline isolate present in repeat culture from original infection site;Presumed Persistence=culture data not available for participants with clinical response of failure;Superinfection=culture from primary infection site had new pathogen not identified as baseline isolate, clinical response was failure. MIC=lowest drug concentration with no visible growth of microorganism.|Up to Day 24 to 35 (10 to 21 days after LDOT)|Data was not analyzed because correlation analysis could not be performed due to insufficient number of participants for whom data for both microbiological outcomes and tigecycline concentration was available.||ratio||Standard Deviation|Mean
769874|NCT00707239|Other Pre-specified|Correlation of AUC(0-24) to Minimum Inhibitory Concentration (MIC) Ratio (AUC [0-24]/MIC) of Tigecycline With Clinical Outcome|Clinical response:Cure =Initial SSx improved;CXR improved/stable;no other antibiotic for pneumonia;no worsening/new SSx. Failure=Persistence/worsening SSx;no clinical improvement/initial improvement with worsening; other antibiotic;CXR progression;death >study day 2 due to pneumonia. Indeterminate=unable to determine outcome for non-study drug/infection reason;death in 2 days after dose 1 for any reason or >2 days but before TOC visit for non-pneumonia reason. MIC=lowest drug concentration with no visible growth of microorganism. AUC(0-24)/MIC:reported for cure and failure/indeterminate.|Up to Day 24 to 35 (10 to 21 days after LDOT)|CE population included those participants who met specified evaluability criteria for efficacy. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||ratio||Standard Deviation|Mean
769875|NCT00707239|Other Pre-specified|Correlation of AUC (0-24) of Tigecycline With Nausea and Vomiting|AUC (0-24) = Area under the serum concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-24). Area under the serum concentration-time curve was derived from the population PK analysis by using each participant’s dose and the post-hoc individual estimated systemic CL, AUC (0-12) = Dose divided by CL. Model-predicted AUC (0-24) was calculated by multiplying AUC (0-12) by 2.|Baseline up to Day 29 to 35 (15 to 21 days after LDOT)|CE population included those participants who met specified evaluability criteria for efficacy. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||mg*hr/mL||Standard Deviation|Mean
769876|NCT00707239|Other Pre-specified|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)] of Tigecycline|AUC (0-24) = Area under the serum concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-24). Area under the serum concentration-time curve was derived from the population pharmacokinetic (PK) analysis by using each participant’s dose and the post-hoc individual estimated systemic CL, AUC (0-12) = Dose divided by CL. Model-predicted AUC (0-24) was calculated by multiplying AUC (0-12) by 2.|Day 3, 4 or 5|CE population included those participants who met specified evaluability criteria for efficacy. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||mg*hr/mL||Standard Deviation|Mean
769877|NCT00707239|Other Pre-specified|Clearance (CL) of Tigecycline|Drug clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the blood. It is defined as the volume of serum from which drug can be completely removed per unit of time.|Day 3, 4 or 5|CE population included those participants who met specified evaluability criteria for efficacy. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||Liter/hr||95% Confidence Interval|Mean
769878|NCT00707239|Other Pre-specified|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-12)] of Tigecycline|AUC (0-12) = Area under the serum concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-12). Area under the serum concentration-time curve was derived from the population pharmacokinetic (PK) analysis by using each participant’s dose and the post-hoc individual estimated systemic CL, AUC (0-12) = Dose divided by CL.|Day 3, 4 or 5|CE population included those participants who met specified evaluability criteria for efficacy. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||ng*hr/mL||Standard Deviation|Mean
769879|NCT00707239|Other Pre-specified|Time to Reach Maximum Observed Serum Concentration (Tmax) of Tigecycline||Day 3, 4 or 5|CE population included those participants who met specified evaluability criteria for efficacy. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||hrs||Full Range|Median
769880|NCT00707239|Other Pre-specified|Maximum Observed Serum Concentration (Cmax) of Tigecycline||Day 3, 4 or 5|CE population included those participants who met specified evaluability criteria for efficacy. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
769881|NCT00707239|Other Pre-specified|Number of Participants With Abnormal Electrocardiogram (ECG)|Potentially clinically significant ECG data: Non-first values greater than 240 millisecond (msec) with increase of greater than or equal to 10 percent (%) from baseline for PR interval; Non-first values greater than or equal to 120 msec for QRS interval; Non-first values greater than 460 msec with increase of greater than or equal to 5% from baseline for corrected QT (QTc) interval; Non-first values greater than 460 msec with increase of greater than or equal to 5% from baseline for QTc using Framingham formula (QTc F).|Baseline up to Day 14 or LDOT|mITT population included all randomized participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||participants|||Number
769882|NCT00707239|Other Pre-specified|Number of Participants With Abnormal Laboratory Examinations|Participants were evaluated for following laboratory parameters: albumin, alkaline phosphatase, amylase, urea (blood urea nitrogen [BUN]), total bilirubin, calcium, magnesium, carbon dioxide, international normalized ratio (INR), chloride, creatinine, glucose, lipase, potassium, phosphorus, aspartate aminotransferase (AST), alanine aminotransferase (ALT), sodium, total protein, hemoglobin, hematocrit, white blood cells, eosinophils, neutrophils, lymphocytes, platelets, prothrombin time, prothrombin activity and partial thromboplastin time.|Baseline up to Day 24 to Day 35 (10 to 21 days after LDOT)|mITT population included all randomized participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||participants|||Number
769883|NCT00707239|Other Pre-specified|Number of Participants Who Experienced Nausea or Vomiting||Baseline up to Day 29 to Day 35 (15 to 21 days after LDOT)|Modified intent-to-treat (mITT) population included all randomized participants who received at least 1 dose of study medication.||participants|||Number
769884|NCT00707239|Secondary|Percentage of Participants With Microbiological Response at the Participant Level Population at Test-of-Cure (TOC) Visit|Microbiological response assessed at participant level. Eradication = baseline isolate not present in repeat culture from the original infection site; Presumed Eradication = clinical response of cure precluded the availability of a specimen for culture; Persistence = baseline isolate present in repeat culture from the original infection site; Presumed Persistence = culture data not available for participants with a clinical response of failure; Superinfection = culture from the primary infection site had new pathogen not identified as a baseline isolate and clinical response was failure.|Up to Day 24 to 35 (10 to 21 days after LDOT)|ME population included participants who met specified evaluability criteria for efficacy, had culture taken from the infected site before first dose of study medication and had at least 1 pathogen, and at least 1 baseline pathogen was susceptible to tigecycline and imipenem/cilastatin regimens.||percentage of participants|||Number
769885|NCT00707239|Secondary|Percentage of Participants With Microbiological Response at the Pathogen Level Population at Test-of-Cure (TOC) Visit|Eradication=baseline isolate not present in repeat culture from the original infection site; Presumed Eradication=clinical response of cure precluded the availability of a specimen for culture; Persistence=baseline isolate present in repeat culture from the original infection site; Presumed Persistence=culture data not available for participants with a clinical response of failure; Indeterminate=unable to determine outcome for non-study drug/infection reasons; no baseline isolate; death in 2 days after 1st dose for any reason, or >2 days but before TOC visit for non-pneumonia reason.|Up to Day 24 to 35 (10 to 21 days after LDOT)|Microbiologically Evaluable (ME) population:participants who met evaluability criteria for efficacy, had culture taken from infected site before dose 1 of study drug, had at least (>=)1 pathogen, >=1 pathogen was susceptible to tigecycline, imipenem/cilastatin regimen; ‘n’ = those participants who had specified pathogen for each group respectively.||percentage of participants|||Number
769901|NCT00707486|Primary|Time to Hemostasis|This outcome measures the time it takes in minutes for the subject's extraction site to stop bleeding. It is divided by intervention.|Minutes After Application|Participants served as their own control thus the total amount of participants is reflected in both of the outcome measures.||Minutes|Participants|Standard Error|Mean
769886|NCT00707239|Secondary|Percentage of Participants With Clinical Response in Ventilator Associated Pneumonia (VAP) and Non-VAP Participants at Test-of-Cure (TOC) Visit|Clinical response: Cure=All initial SSx improved; CXR improved/stable; no other antibiotics for pneumonia; no worsening or new SSx. Failure=Persistence or worsening SSx; no clinical improvement or initial improvement with clinically important worsening; other antimicrobials for pneumonia; CXR progression; death > study day 2 due to pneumonia. Indeterminate=unable to determine outcome for non-study drug/infection reasons (e.g., lost to follow-up); death in 2 days after 1st dose for any reason, or >2 days but before TOC visit for non-pneumonia reason.|Up to Day 24 to 35 (10 to 21 days after LDOT)|CE population included those participants who met specified evaluability criteria for efficacy. 'n' is signifying those participants who were evaluable for this measure and included in VAP (suffering from VAP) and non-VAP group (not suffering from VAP) for each group respectively.||percentage of participants|||Number
769887|NCT00707239|Secondary|Percentage of Participants With Clinical Response in Clinical Modified Intent-to-treat (c-mITT) Population at Test-of-Cure (TOC) Visit|Clinical response: Cure=All initial SSx improved; CXR improved/stable; no other antibiotics for pneumonia; no worsening or new SSx. Failure=Persistence or worsening SSx; no clinical improvement or initial improvement with clinically important worsening; other antimicrobials for pneumonia; CXR progression; death > study day 2 due to pneumonia. Indeterminate=unable to determine outcome for non-study drug/infection reasons (e.g., lost to follow-up); death in 2 days after 1st dose for any reason, or >2 days but before TOC visit for non-pneumonia reason.|Up to Day 24 to 35 (10 to 21 days after LDOT)|c-mITT population included all participants who were randomly assigned to receive intravenous study medication and had clinical evidence of hospital-acquired pneumonia (HAP).||percentage of participants|||Number
769888|NCT00707239|Primary|Percentage of Participants With Clinical Response in Clinically Evaluable (CE) Population at Test-of-Cure (TOC) Visit|Clinical response: Cure=All initial signs/symptoms of pneumonia (SSx) improved; chest x-ray (CXR) improved/stable; no other antibiotics for pneumonia; no worsening or new SSx. Failure=Persistence or worsening SSx; no clinical improvement or initial improvement with clinically important worsening; other antimicrobials for pneumonia; CXR progression; death > study day 2 due to pneumonia. Indeterminate=unable to determine outcome for non-study drug/infection reasons (e.g., lost to follow-up); death in 2 days after 1st dose for any reason, or >2 days but before TOC visit for non-pneumonia reason.|Up to Day 24 to 35 (10 to 21 days after last day of therapy [LDOT])|CE population included those participants who met specified evaluability criteria for efficacy.||percentage of participants|||Number
769889|NCT00707343|Primary|Area Under the Receiver Operating Curve (ROC AUC) Values for PET Imaging Techniques|"The ROC AUC represents the probability that tumor recurrence will be differentiated from radiation necrosis.
Positron Emission Tomography (PET) imaging methods using radiopharmaceutical agents F-18 fluorodeoxyglucose (FDG) and F-18 fluorothymidine (FLT) were used for analysis. For F-18 FDG, the maximum standardized uptake value (SUVmax) with correction for body weight was measured at suspicious area of lesion enhancement. The ratio of F-18 FDG SUVmax of the suspicious lesion to that of the SUVmean of a 1 cm diameter region of normal contralateral white matter was also measured (F-18 FDG ratio lesion: contralateral white matter). For F-18 FLT, the maximum standardized uptake value (SUVmax) was measured at suspicious area of lesion enhancement. Patlak graphical analysis was applied using the metabolite-corrected plasma input function to obtain voxel-wise estimates of the FLT metabolic influx parameter (F-18 FLT Kimax)."|30 minutes for FDG imaging, 70 minutes for FLT imaging acquisition; 2-33 months for lesion outcome confirmation|||Probability||95% Confidence Interval|Number
769890|NCT00707447|Secondary|Emotional Well-being/ Depression (CES-D)|"The Center for Epidemiologic Studies Depression Scale (CES-D) consists of 20 items scored from 0 to 3. Scores are summated, with raw score ranging from 0 to 25. Higher Scores idicate a higher depressive state.
Mean change in depression score (CES-D) after 12 months"|12 months|||units on a scale||Standard Deviation|Mean
769891|NCT00707447|Secondary|Psychological Well-being (WHO-5)|"The WHO (Five) Well-being index consists of 5 items on the overall well-being over the last two weeks. Each of the five items is rated from 0 (= not present) to 5 (= constantly present). Scores are summated, with raw score ranging from 0 to 25. Then the scores are transformed to 0-100 by multiplying by 4, with higher scores meaning better well-being.
Mean change in psychological well-being score (WHO-5) after 12 months"|12 months|||units on a scale||Standard Deviation|Mean
769892|NCT00707447|Secondary|Eating Behavior (TFEQ) - Hunger|"The Three-Factor Eating Questionnaire (TFEQ) is a questionnaire used to assess food intake-behavior related research. The three factors of the TFEQ are: dietary restraint, disinhibition and hunger. The TFEQ contains 51 dichotomous Items (apply/ doesn't apply). The subscale hunger consists of 14 Item with a minimum score of 0 and a maximum score of 14. Low scores indicate an eating behavior strongly depending on feelings of hunger.
Mean change in the TFEQ - hunger scale after 12 months"|12 months|||units on a scale||Standard Deviation|Mean
769893|NCT00707447|Secondary|Eating Behavior (TFEQ) - Disinhibition|"The Three-Factor Eating Questionnaire (TFEQ) is a questionnaire used to assess food intake-behavior related research. The three factors of the TFEQ are: dietary restraint, disinhibition and hunger. The TFEQ contains 51 dichotomous Items (apply/ doesn't apply). The subscale disinhibition consists of 16 Item with a minimum score of 0 and a maximum score of 16. High scores indicate an uninhibited eating behavior strongly depending on external cues.
Mean change in the TFEQ - disinhibition scale after 12 months"|12 months|||units on a scale||Standard Deviation|Mean
769894|NCT00707447|Secondary|Eating Behavior (TFEQ) - Cognitive Restraint|"The Three-Factor Eating Questionnaire (TFEQ) is a questionnaire used to assess food intake-behavior related research. The three factors of the TFEQ are: dietary restraint, disinhibition and hunger. The TFEQ contains 51 dichotomous Items (apply/ doesn't apply). The subscale cognitive restraint consists of 21 Item with a minimum score of 0 and a maximum score of 21. Low scores indicate an uninhibited eating behavior.
Mean change in the TFEQ - cognitive restraint scale after 12 months"|12 months|||units on a scale||Standard Deviation|Mean
769895|NCT00707447|Secondary|Physical Exercise|Mean changes in physical exercise (in min/week) after 12 months|12 months|||minutes per week||Standard Deviation|Mean
769896|NCT00707447|Secondary|Glucose Tolerance|Mean change in 2 hour postprandial oral glucose tolerance test (oGTT) (in mg/dl) after 12 months|12 months|||mg/dl||Standard Deviation|Mean
769897|NCT00707447|Secondary|Fasting Glucose|Mean changes in fasting glucose (in mg/dl) after 12 month|12 months|||mg/dl||Standard Deviation|Mean
769898|NCT00707447|Primary|Waist Circumference|Mean change in waist circumference (in cm) after 12 months|12 months|||cm||Standard Deviation|Mean
769906|NCT00707746|Other Pre-specified|High-Density Lipoprotein Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set||mg/dL||Standard Deviation|Mean
769907|NCT00707746|Other Pre-specified|Percent Change From Baseline in High-Density Lipoprotein Cholesterol at the Primary Efficacy Time Point|High-density lipoprotein cholesterol (HDL-C) was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|The Full Analysis Set, which consisted of all randomized patients who received at least 1 injection of study drug (mipomersen or placebo) and with a valid baseline and at least 1 post-baseline LDL-C measurement.||percentage of baseline||Standard Deviation|Mean
769908|NCT00707746|Other Pre-specified|Apolipoprotein A1 at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set||mg/dL||Standard Deviation|Mean
769909|NCT00707746|Other Pre-specified|Percent Change From Baseline in Apolipoprotein A1 at the Primary Efficacy Time Point|Apolipoprotein A1 was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|The Full Analysis Set, which consisted of all randomized patients who received at least 1 injection of study drug (mipomersen or placebo) and with a valid baseline and at least 1 post-baseline LDL-C measurement.||percentage of baseline||Standard Deviation|Mean
769910|NCT00707746|Other Pre-specified|Ratio of Low-Density Lipoprotein Cholesterol to High-Density Lipoprotein Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set||ratio||Standard Deviation|Mean
769911|NCT00707746|Other Pre-specified|Percent Change From Baseline in the Ratio of Low-Density Lipoprotein Cholesterol to High-Density Lipoprotein Cholesterol at the Primary Efficacy Time Point|The ratio of low-density lipoprotein (LDL) cholesterol to high-density lipoprotein (HDL) cholesterol was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|The Full Analysis Set, which consisted of all randomized patients who received at least 1 injection of study drug (mipomersen or placebo) and with a valid baseline and at least 1 post-baseline LDL-C measurement.||percentage of baseline||Standard Deviation|Mean
769912|NCT00707746|Other Pre-specified|Very Low Density Lipoprotein Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set||mg/dL||Standard Deviation|Mean
769913|NCT00707746|Other Pre-specified|Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol at the Primary Efficacy Time Point|Very low density lipoprotein cholesterol was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|The Full Analysis Set, which consisted of all randomized patients who received at least 1 injection of study drug (mipomersen or placebo) and with a valid baseline and at least 1 post-baseline LDL-C measurement.||percentage of baseline||Standard Deviation|Mean
769914|NCT00707746|Other Pre-specified|Lipoprotein (a) at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set||mg/dL||Standard Deviation|Mean
769915|NCT00707746|Other Pre-specified|Percent Change From Baseline in Lipoprotein (a) at the Primary Efficacy Time Point|Lipoprotein (a) was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|The Full Analysis Set, which consisted of all randomized patients who received at least 1 injection of study drug (mipomersen or placebo) and with a valid baseline and at least 1 post-baseline LDL-C measurement.||percentage of baseline||Standard Deviation|Mean
769916|NCT00707746|Other Pre-specified|Triglycerides at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set||mg/dL||Standard Deviation|Mean
769945|NCT00707967|Primary|Number of Subjects With Haematological Levels Above Normal|Among biochemical and haematological parameters assessed were haematocrit [Hct], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were – normal, below and above.|At Day 0, 7, 30, 37 and 60|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subjects|||Number
769917|NCT00707746|Other Pre-specified|Percent Change From Baseline in Triglycerides at the Primary Efficacy Time Point|Triglycerides were measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|The Full Analysis Set, which consisted of all randomized patients who received at least 1 injection of study drug (mipomersen or placebo) and with a valid baseline and at least 1 post-baseline LDL-C measurement.||percentage of baseline||Standard Deviation|Mean
769918|NCT00707746|Secondary|Non-High-Density Lipoprotein Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set||mg/dL||Standard Deviation|Mean
769919|NCT00707746|Secondary|Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol at the Primary Efficacy Time Point|Non-high-density lipoprotein cholesterol was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|The Full Analysis Set, which consisted of all randomized patients who received at least 1 injection of study drug (mipomersen or placebo) and with a valid baseline and at least 1 post-baseline LDL-C measurement.||percentage of baseline||Standard Deviation|Mean
769920|NCT00707746|Secondary|Total Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set||mg/dL||Standard Deviation|Mean
769921|NCT00707746|Secondary|Percent Change From Baseline in Total Cholesterol at the Primary Efficacy Time Point|Total cholesterol was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|The Full Analysis Set, which consisted of all randomized patients who received at least 1 injection of study drug (mipomersen or placebo) and with a valid baseline and at least 1 post-baseline LDL-C measurement.||percentage of baseline||Standard Deviation|Mean
769922|NCT00707746|Secondary|Apolipoprotein B at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set||mg/dL||Inter-Quartile Range|Median
769923|NCT00707746|Secondary|Percent Change From Baseline in Apolipoprotein B at the Primary Efficacy Time Point|Apolipoprotein B was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|The Full Analysis Set, which consisted of all randomized patients who received at least 1 injection of study drug (mipomersen or placebo) and with a valid baseline and at least 1 post-baseline LDL-C measurement.||percentage of baseline||Inter-Quartile Range|Median
769924|NCT00707746|Primary|Summary of Participants With Adverse Events|"The on-treatment time frame spanned the time during which the study drug was administered until the later of the primary efficacy time point and 14 days beyond the last study drug date.
Adverse events (AEs) were considered related if assessed by the Investigator as possibly, probably or definitely related to study drug.
Severity was assessed as:
Mild-symptom barely noticeable to the patient or do not make the patient uncomfortable;
Moderate-symptom makes the patient uncomfortable, affects performance of daily activities;
Severe-symptom causes the patient severe discomfort, may cause cessation of treatment with the study drug.
Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention."|Pre-treatment (prior to first dose), On-treatment (Day 1 to week 28), Post-treatment (Week 28-52)|Safety set of all randomized participants who received at least one injection of study drug.||participants|||Number
769925|NCT00707746|Primary|Low-density Lipoprotein Cholesterol at Baseline and the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set||mg/dL||Standard Deviation|Mean
769926|NCT00707746|Primary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at the Primary Efficacy Time Point|LDL-C was measured in mg/dL. Samples were taken following an overnight fast. For patients with triglycerides <400 mg/dL, LDL-C was obtained using Friedewald's calculation; and for patients with triglycerides ≥400 mg/dL, LDL-C was directly measured by the central laboratory using ultracentrifugation. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|The Full Analysis Set, which consisted of all randomized patients who received at least 1 injection of study drug (mipomersen or placebo) and with a valid baseline and at least 1 post-baseline LDL-C measurement.||percentage of baseline||Standard Deviation|Mean
769927|NCT00707759|Secondary|Growth-factors (IGF-I, IGFBP-3) Bone Metabolism (FA, Ca/Cru, CaxP, 25(OH)VitD, FGF23, Klotho, PTH, DXA, pQCT) Insulin-sensitivity by ISI Method. Molecular Markers - Acute Rejection (FOXP3/IL-17). Acute Rejection Incidence/Protocol Renal Biopsy||12 months||||||
769930|NCT00707915|Secondary|Clinical Global Impression (CGI)|The CGI rating scales are commonly used measures of symptom severity, treatment response and the efficacy of treatments in treatment studies of patients with mental disorders (Guy, W., 1976). The CGI - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. This will be performed at week 8.|Week 8|||units on a scale||Standard Deviation|Mean
769931|NCT00707915|Secondary|Leeds Sleep Evaluation Questionnaire (LSEQ)|The LSEQ comprises 10 self-rating 100-mm-line analogue questions regarding changes in the quality of sleep and early morning behavior, following any given intervention. Scores range between 0 and 100. Scores beneath 50 indicate better sleep. This will be performed at week 8.|Week 8|||units on a scale||Standard Deviation|Mean
769932|NCT00707915|Secondary|Critical Flicker Fusion Test (CFF)|The CFF threshold has been regarded as a functional measure of psychomotor function. Sub-threshold intermittent light is perceived as a flicker. If the frequency is gradually increased, the flicker becomes gradually less distinct until it is finally perceived as a continuous light (fusion threshold). The device (T.K.K.501c) provides luminance with a mean intensity of 500Lux±10% and a range of frequency of 20-60Hz. A change in the critical fusion frequency from baseline to week 8 will be recorded.|Baseline and week 8|||Hz||Standard Deviation|Mean
769933|NCT00707915|Secondary|Clinical Stabilometric Platform (CSP)|CSP (ANIMA® GS-7, Tokyo) measures a total length of the trunk motion by varying the resistance applied to the platform for 30 seconds with eyes closed with feet together. Change in the total length of the trunk motion from baseline to week 8 will be recorded.|Baseline and week 8|||cm||Standard Deviation|Mean
769934|NCT00707915|Secondary|A Change in a Total Scale Score in the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), Japanese Version, From Baseline to Week 8.|This brief test is to assess areas of cognitive functioning and profile impairment across domains with 12 subtests, including: List Learning, Story Memory, Figure Copy, Line Orientation, Digit Span, Coding, Picture Naming, Semantic Fluency, List Recall, List Recognition, Story Recall, and Figure Recall. This assessment is repeatable and not subject to practice effects. A total scale score ranges between 40 and 160; a higher score indicates better cognitive function. A change in the score between the baseline and week 8 is defined as a secondary outcome measure.|Baseline and week 8|||units on a scale||Standard Deviation|Mean
769935|NCT00707915|Primary|Completion Rate|The number of subjects who have successfully completed dose-reduction and all the assessments scheduled until week 8 divided by the total number of enrolled subjects|8 weeks|||percentage of successful completers|||Number
769936|NCT00707954|Secondary|Pharmacodynamics- 1)Urinary Glucose Excretion; 2)Plasma Glucose Concentration; 3)Insulin Concentration in Serum; 4)Insulinogenic Index;and 5)Hemoglobin A1c and Glycoalbumin||18 days||||||
769937|NCT00707954|Secondary|Pharmacokinetics- 1)Plasma Concentration of TA-7284: Tmax,Cmax, AUC, Etc.; and 2)Urinary Excretion of TA-7284: Ae, Ae%, CLr||19 days||||||
769938|NCT00707954|Primary|Safety: Adverse Events, Adverse Drug Reactions|In the safety analysis population, adverse events incidences and adverse drug reactions incidences were calculated by dose.|19 days|||percentage of incidences|||Number
769939|NCT00707967|Secondary|Number of Subjects With Significant Highly Active Anti-Retroviral Therapy (HAART) Changes|Recorded significant HAART change refers to one subject switching the Combivir drug to Truvada as planned by personal physician, with no relationship to vaccination, prior to study enrolment.|From Day 60 to Day 210|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subjects|||Number
769940|NCT00707967|Secondary|Anti-M72 Specific Antibody Concentrations|Concentrations given in Enzyme-Linked Immunosorbent Assay units per milliliter (EL.U/mL) were expressed in Geometric Mean Concentrations (GMCs).|At Day 0, 30, 60 and 210|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
769941|NCT00707967|Secondary|Cell Count of CD4+ T Cells|CD4+ T cell counts are defined by values greater than (>) 200 cells per cubic millimeters (mm3) at screening for enrolment into the study.|At Day 0, 30, 60 and 210|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||T cells/cubic millimeter||Inter-Quartile Range|Median
769942|NCT00707967|Secondary|Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule|"Expressed cytokine combinations for CD4+ T cells were CD40-L and interleukin-2 [IL-2] or interferon-gamma [IFN-γ] or tumour necrosis factor-alpha [TNF-α]; IL-2 and CD40-L, or IFN-γ, or TNF-α; IFN-γ and CD40-L, or IL-2, or TNF-α; TNF-α and CD40-L, or IL-2, or IFN-γ.
For CD8+ T cells no vaccine induced responses were observed, thus results are presented only for the frequency of M72-specific CD8+ T cells expressing at least two cytokines."|At Day 0, 30, 60 and 210|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.||T cells/million cells||Inter-Quartile Range|Median
769943|NCT00707967|Secondary|Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines|Among cytokines expressed were interleukin-2 [IL-2] and/or interferon-gamma [IFN-γ] and/or tumour necrosis factor-alpha [TNF-α] and/or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS).|At Day 0, 30, 60 and 210|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.||T cells/million cells||Inter-Quartile Range|Median
769944|NCT00707967|Primary|Number of Subjects With Haematological Levels Above Normal|Among biochemical and haematological parameters assessed were [PLA], red blood cells [RBC] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were – normal, below and above.|At Day 0, 7, 30, 37 and 60|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subjects|||Number
769983|NCT00707993|Secondary|Incidence of Hyperglycemic Rescue|The number of participants requiring rescue for failing to achieve pre-specified glycemic targets during the 52 week study.|On Occurrence (up to 52 weeks).|All randomized participants who had at least 1 dose of study medication (full analysis set). Participants who discontinued prior to Week 2 were excluded from analysis.||participants|||Number
769946|NCT00707967|Primary|Number of Subjects With Biochemical and Haematological Levels Above Normal|Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CREA], eosinophil [EOS]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were – normal, below and above.|At Day 0, 7, 30, 37 and 60|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subjects|||Number
769947|NCT00707967|Primary|Number of Subjects With Haematological Levels Below Normal|Among biochemical and haematological parameters assessed were [PLA], red blood cells [RBC] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were – normal, below and above.|At Day 0, 7, 30, 37 and 60|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subjects|||Number
769948|NCT00707967|Primary|Number of Subjects With Haematological Levels Below Normal|Among biochemical and haematological parameters assessed were haematocrit [Hct], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were – normal, below and above.|At Day 0, 7, 30, 37 and 60|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subjects|||Number
769949|NCT00707967|Primary|Number of Subjects With Biochemical and Haematological Levels Below Normal|Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CREA], eosinophil [EOS]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were – normal, below and above.|At Day 0, 7, 30, 37 and 60|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subjects|||Number
769950|NCT00707967|Primary|Number of Subjects With Normal Haematological Levels|Among biochemical and haematological parameters assessed were platelets [PLA], red blood cells [RBC] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were – normal, below and above.|At Day 0, 7, 30, 37 and 60|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subjects|||Number
769951|NCT00707967|Primary|Number of Subjects With Normal Haematological Levels|Among biochemical and haematological parameters assessed were haematocrit [Hct], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were – normal, below and above.|At Day 0, 7, 30, 37 and 60|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subjects|||Number
769952|NCT00707967|Primary|Number of Subjects With Normal Biochemical and Haematological Levels|Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CREA], eosinophil [EOS]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were – normal, below and above.|At Day 0, 7, 30, 37 and 60|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subjects|||Number
769953|NCT00707967|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity|During the entire study period, from Day 0 up to Day 210|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subjects|||Number
769954|NCT00707967|Primary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset out-side the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 30-day period (Days 0-29) post vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subjects|||Number
769955|NCT00707967|Primary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms were fatigue, temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastrointestinal symptoms (gastro) [nausea, vomiting, diarrhoea and/or abdominal pain], headache, malaise and myalgia. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day period (Days 0-6) post vaccination following each dose|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subjects|||Number
769956|NCT00707967|Primary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. Relationship analysis was not performed.|During the 7-day period (Days 0-6) post vaccination following each dose|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subjects|||Number
769957|NCT00707980|Secondary|Health Care Resource Utilization Assessed by the Health Economic Assessment Questionnaire|Healthcare resource utilization was assessed by the Health Economic Assessment (HEA) questionnaire, which monitors participants absenteeism from work, as well as resource use such as visits to a general practitioner, outpatient and inpatient services, hospitalization, medications, and other relevant services over the past 8 weeks.|Baseline and Week 52|Safety set with available data||participants|||Number
769958|NCT00707980|Secondary|Change From Baseline to the Final Visit in the Sheehan Disability Scale|The Sheehan Disability Scale (SDS) assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment.|Baseline and Week 52|Participants in the safety analysis set who had at least 1 post-baseline efficacy measurement, and with available Final Visit data.||scores on a scale||Standard Deviation|Mean
769959|NCT00707980|Secondary|Change From Baseline to the Final Visit in 36-item Short-form Health Survey (SF-36)|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The 8 health concepts are: 1. Limitation in physical activities because of health problems. 2. Limitations in usual role activities because of physical health problems. 3. Bodily pain. 4. Limitations in social activities because of physical or emotional problems. 5. General mental health (psychological distress and well-being). 6. Limitations in usual role activities because of emotional problems. 7. Vitality (energy and fatigue). 8. General health perception. Each scale ranges from 0 (best) - 100 (worst).|Baseline and Week 52|Participants in the safety analysis set who had at least 1 post-baseline efficacy measurement, and with available Final Visit data.||scores on a scale||Standard Deviation|Mean
769960|NCT00707980|Secondary|Change From Baseline in the Clinical Global Impression of Severity of Illness Scale|The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. Final Visit includes data from Week 52 or earlier for participants who didn't complete the 52 weeks.|Baseline and Weeks 4, 24 and 52|"Participants in the safety analysis set who had at least 1 post-baseline efficacy measurement, and with available data. n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Deviation|Mean
769961|NCT00707980|Secondary|Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Final Visit includes data from Week 52 or earlier for participants who didn't complete the 52 weeks.|Baseline and Weeks 4, 24 and 52|"Participants in the safety analysis set who had at least 1 post-baseline efficacy measurement, and with available data. n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Deviation|Mean
769962|NCT00707980|Secondary|Change From Baseline in the Montgomery Åsberg Depression Rating Scale (MADRS) Total Score|The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement. Final Visit includes data from Week 52 or earlier for participants who didn't complete the 52 weeks.|Baseline and Weeks 4, 24 and 52|"Participants in the safety analysis set who had at least 1 post-baseline efficacy measurement, and with available data. n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Deviation|Mean
769963|NCT00707980|Secondary|Change From Baseline in Hamilton Depression Scale-24 Item (HAM-D24) Total Score|The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74 where a higher score indicates a greater depressive state. Final Visit includes data from Week 52 or earlier for participants who didn't complete the 52 weeks.|Baseline and Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 36, 44 and 52.|"Participants in the safety analysis set who had at least 1 post-baseline efficacy measurement, and with available data. n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Deviation|Mean
769964|NCT00707980|Primary|Number of Participants With Potentially Clinically Significant Vital Sign Findings|Participants with at least one potentially clinically significant post-baseline vital sign finding. The definition of clinically significant is included in the table below for each parameter. SSBP = supine systolic blood pressure; SDBP = supine diastolic blood pressure.|Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 36, 44 and 52|Safety set||participants|||Number
769965|NCT00707980|Primary|Number of Participants With Adverse Events (AEs)|"The intensity (severity) of each AE was defined as:
Mild: caused minimal discomfort and did not interfere in a significant manner with normal activities.
Moderate: sufficiently uncomfortable to produce some impairment of normal activities.
Severe: incapacitating, preventing the patient from participating in normal activities.
The causal relationship between an AE and study drug was assessed by the investigator as Probable, Possible or Not Related; Related=AEs with causality of Possibly or Probably. A serious AE (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, led to a congenital anomaly/birth defect, or was an important medical event that either jeopardized the patient, required intervention to prevent any of the SAEs defined above, a suicide attempt or an abortion."|From the first dose of open-label study drug until 4 weeks after the last dose (up to 56 weeks)|Safety set||participants|||Number
769966|NCT00707980|Primary|Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings|A standard 12-lead ECG was performed at the designated study visits. The central reader reviewed and recorded the intervals (PR, QRS, RR, QT, and corrected QT interval [QTc]), and interpreted the ECG using 1 of the following categories: within normal limits or abnormal. The number of participants with at least one post-baseline potentially clinically significant ECG finding is reported. bpm = beats per minute; QTcB = QT interval corrected using Bazett's formula; QTcF = QT interval corrected using Fridericia's formula.|Weeks 4, 12, 24, 36 and 52|Safety set||participants|||Number
769967|NCT00707980|Primary|Number of Participants With Potentially Clinically Significant Laboratory Evaluation Findings|Participants with at least one post-baseline potentially clinically significant (as defined in the table below) serum chemistry, hematology or urinalysis result. ULN = upper limit of normal; LLN = Lower limit of normal.|Weeks 4, 8, 12, 20, 28, 36, 44 and 52|Safety set||participants|||Number
770020|NCT00715793|Secondary|1-year Overall Survival (OS) Rate|Percentage of patients alive at one year (number of patients alive / total number of evaluable (analyzed) patients).|12 months|||percentage of participants|||Number
769968|NCT00707980|Primary|Physical Examination Findings|"Physical examination consisted of the following body systems: (1) appearance; (2) extremities; (3) skin; (4) head and neck; (5) eyes, ears, nose, and throat; (6) lungs and chest; (7) heart and cardiovascular system; (8) abdomen; and (9) musculoskeletal system. An assessment of the nervous system was conducted; any findings were captured under the appropriate body area.
Each system was assessed as normal or abnormal."|Baseline and Week 52|The safety set included all participants who enrolled and received at least 1 dose of open-label study medication. Results include data for participants with available data at each time point; 834 participants at Baseline and 524 participants at Week 52.||participants|||Number
769969|NCT00707993|Secondary|Incidence of Glycosylated Hemoglobin Decrease From Baseline.|The percentage of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 0.5, 1.0, 1.5 and 2.0% during the 52 week study.|Baseline and Week 52.|All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.||percentage of participants|||Number
769970|NCT00707993|Secondary|Incidence of Subjects Achieving Glycosylated Hemoglobin <=7%|The percentage of participants with a value for the percentage of glycosylated hemoglobin (HbA1c; the percentage of hemoglobin that is bound to glucose) less than or equal to 6.5 and 7.0% during the 52 week study.|Baseline and Week 52.|All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.||percentage of participants|||Number
769971|NCT00707993|Secondary|Change From Baseline in High Sensitivity C-reactive Protein|The change between the high sensitivity C-reactive protein value collected at each week indicated including final visit from baseline.|Baseline, Week 12, Week 26, Week 42 and Week 52.|All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.||mg/L||Standard Error|Least Squares Mean
769972|NCT00707993|Secondary|Change From Baseline in Serum Lipids (Triglycerides)|The change in triglycerides measured at each week indicated including final visit from baseline.|Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52.|All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.||mg/dL||Standard Error|Least Squares Mean
769973|NCT00707993|Secondary|Change From Baseline in Serum Lipids (Low-Density Lipoprotein Cholesterol)|The change in low-density lipoprotein cholesterol measured at each week indicated including final visit from baseline.|Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52.|All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.||mg/dL||Standard Error|Least Squares Mean
769974|NCT00707993|Secondary|Change From Baseline in Serum Lipids (High-Density Lipoprotein Cholesterol)|The change in high-density lipoprotein cholesterol measured at each week indicated including final visit from baseline.|Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52.|All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.||mg/dL||Standard Error|Least Squares Mean
769975|NCT00707993|Secondary|Change From Baseline in Serum Lipids (Total Cholesterol)|The change in total cholesterol measured at each week indicated including final visit from baseline.|Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52.|All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.||mg/dL||Standard Error|Least Squares Mean
769976|NCT00707993|Secondary|Change From Baseline in Body Weight|The change in body weight measured at each week indicated including final visit from baseline.|Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52.|All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.||kg||Standard Error|Least Squares Mean
769977|NCT00707993|Secondary|Homeostasis Model Assessment of Beta Cell Function|The change between homeostasis model assessment of beta cell function collected at each week indicated including final visit relative to baseline. Homeostasis model assessment of beta cell function measures beta cell function, calculated by a constant (20) times insulin, divided by fasting plasma glucose minus a constant (3.5).|Baseline, Week 12, Week 26, Week 42 and Week 52.|All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.||percent score of beta cell function||Standard Error|Least Squares Mean
769978|NCT00707993|Secondary|Change From Baseline in Proinsulin/Insulin Ratio|The change between the ratio value of proinsulin and insulin collected at each week indicated including final visit relative to baseline.|Baseline, Week 12, Week 26, Week 42 and Week 52.|All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.||ratio||Standard Error|Least Squares Mean
769979|NCT00707993|Secondary|Change From Baseline in Insulin|The change between the value of insulin collected at each week indicated including final visit relative to baseline.|Baseline, Week 12, Week 26, Week 42 and Week 52.|All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.||mcIU/mL||Standard Error|Least Squares Mean
769980|NCT00707993|Secondary|Change From Baseline in Fasting Proinsulin|The change between the value of fasting proinsulin collected at each week indicated including final visit relative to baseline.|Baseline, Week 12, Week 26, Week 42 and Week 52.|All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.||pmol/L||Standard Error|Least Squares Mean
769981|NCT00707993|Secondary|Change From Baseline in 2-hour Postprandial Glucose|The change in postprandial (after eating a meal) glucose levels at week 52 relative to baseline. Standard 2-hour postprandial glucose (PPG) tests performed following an overnight fast and evaluated right before and after a 120-minute (2-hour) timeframe relative to ingestion of a standard oral glucose drink.|Baseline and Week 52.|All randomized participants who had at least 1 dose of study medication (full analysis set).||mg/dL||Standard Error|Least Squares Mean
769982|NCT00707993|Secondary|Change From Baseline in Fasting Plasma Glucose|The change in the value of fasting plasma glucose collected at each week indicated including final visit relative to baseline.|Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 26, Week 34, Week 42 and Week 52.|All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.||mg/dL||Standard Error|Least Squares Mean
770021|NCT00715793|Secondary|Overall Survival (OS)|OS was defined as the time from study entry until the death or date of last contract.|Up to 42 months|||months||95% Confidence Interval|Median
769984|NCT00707993|Secondary|Incidence of Marked Hyperglycemia (Fasting Plasma Glucose ≥200 mg Per dL).|The number of participants with a fasting plasma glucose value ≥ to 200 mg per dL during the 52 week study.|On Occurrence (up to 52 weeks).|All randomized participants who had at least 1 dose of study medication (full analysis set).||participants|||Number
769985|NCT00707993|Secondary|Incidence of Hypoglycemia|Percentage of participants with at least one hypoglycemic episode during 52 week study.|On occurrence (up to 52 weeks).|Percentages based on the number of Safety Set participants in each treatment group.||percentage of participants|||Number
769986|NCT00707993|Secondary|Change From Baseline in Glycosylated Hemoglobin|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at each week indicated including final visit relative to baseline.|Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 26, Week 34 and Week 42.|Randomized participants who received at least 1 dose of study drug, had measurements at Baseline and at the visit, and who met pre-specified criteria (no major protocol violations) for inclusion in the Per Protocol Set. Missing data were imputed using last observation carried forward (LOCF).||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
769987|NCT00707993|Primary|Change From Baseline in Glycosylated Hemoglobin at Week 52.|The change in the percentage of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 52 or final visit and glycosylated hemoglobin collected at baseline.|Baseline and Week 52.|Randomized participants who received at least 1 dose of study drug, had measurements at Baseline and at the visit, and who met pre-specified criteria (no major protocol violations) for inclusion in the Per Protocol Set. Missing data were imputed using last observation carried forward (LOCF).||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
769988|NCT00715208|Secondary|Number of Patients Who Experienced at Least One Serious Adverse Event||From completion of informed consent through 30 days after the last dose of study drug|Safety Population: Treated patients||participants|||Number
769989|NCT00715208|Secondary|Duration of Response|"Time (in months) from the first documentation of a response (CR or partial response [PR]) to the date of first documentation of progressive disease or relapse from complete response.
CR is defined as disappearance of all evidence of disease assessed by CT or PET; PR is defined as regression of measurable disease and no new sites assessed by CT or PET according to the revised International Working Group (IWG) Criteria."|2 years|Responders: CR + PR (Not done for VELCADE R-CAP, only 5 responders)||Months||95% Confidence Interval|Median
769990|NCT00715208|Secondary|Percentage of Participants With Progression-free Survival (PFS) at 1 Year|PFS was defined as the time from the first dose to the date of progressive disease (PD)/relapse or death, whichever comes first. For a participant who had not progressed/relapsed or died, PFS was censored at the last response assessment that was stable disease (failure to attain complete response/partial response or PD or better).|Assessed at at the end of Cycle 2, at end of treatment visit, and every 12± 1 weeks for the first year (4 visits) until PD|Safety population: Treated||percentage of participants|||Number
769991|NCT00715208|Secondary|Number of Participants With Overall Response (OR)|"OR = Complete Response (CR) + Partial Response (PR)according to the revised International Working Group (IWG) Criteria.
CR is the disappearance of all evidence of disease assessed by CT and PET. PR is the regression of measurable disease and no new sites assessed by CT and PET."|30 weeks|Response evaluable: measurable disease at baseline, completed first scheduled response evaluation, or do not complete first scheduled response evaluation due to PD or death.||participants|||Number
769992|NCT00715208|Primary|Number of Patients With Complete Response (CR)|Disappearance of all evidence of disease assessed by computed tomography (CT) and PET (position-emission tomography) according to the revised International Working Group (IWG) Criteria.|30 weeks|Response evaluable: measurable disease at baseline, completed first scheduled response evaluation, or do not complete first scheduled response evaluation due to progressive disease (PD) or death.||participants|||Number
769993|NCT00715299|Primary|The Primary Outcome Measure Was Pre-treatment to Post-treatment Change in Self-selected Walking Speed.|Walking speed is a continuous measure descriptive of overall ambulatory function. This is easily captured with a pressure-sensitive walkway. Three of the 30 participants who completed the study had incomplete data sets, so outcomes are reported on an n=27.|Pre and post Treatment|||meters per second||Standard Deviation|Mean
769994|NCT00715390|Primary|Arrhythmias During General Anesthesia in Children||July 1998 through July 2004|||participants|||Number
769995|NCT00715403|Primary|Difference From Baseline for Electrolytes|Difference from baseline (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.|From signing the informed consent until end of treatment, up to 991 days|Treated set.||mmol/L||Standard Error|Median
769996|NCT00715403|Primary|Difference From Baseline for Coagulation Parameters|Difference from baseline (normalized value) in coagulation parameters Prothrombin time, international normalised ratio (PT-INR) and partial thromboplastin time. Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.|From signing the informed consent until end of treatment, up to 991 days|Treated set.||sec||Standard Error|Median
769997|NCT00715403|Primary|Difference From Baseline for Haematology and Differentials Parameters|Difference from baseline (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.|From signing the informed consent until end of treatment, up to 991 days|Treated set.||10^9 /L||Standard Error|Median
769998|NCT00715403|Primary|Difference From Baseline for Haemoglobin|Difference from baseline for Haemoglobin (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.|From baseline until end of treatment, up to 991 days|Treated set.||g/dL||Standard Error|Median
769999|NCT00715403|Primary|Difference From Baseline for Bilirubin, Creatinine and Glucose|Difference from baseline (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.|From signing the informed consent until end of treatment, up to 991 days|Treated set.||mg/dL||Standard Error|Median
770000|NCT00715403|Primary|Difference From Baseline for Liver Enzymes|Difference from baseline (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.|From signing the informed consent until end of treatment, up to 991 days|Treated set.||U/L||Standard Error|Median
770001|NCT00715403|Primary|Incidence and Intensity of Adverse Events With Highest CTCAE Grade 5|All patients who had grade 5 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).|From signing the informed consent until final follow-up, up to 991 days|Treated set||percentage of participants|||Number
770002|NCT00715403|Primary|Incidence and Intensity of Adverse Events With Highest CTCAE Grade 4|All patients who had grade 4 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).|From signing the informed consent until final follow-up, up to 991 days|Treated set||percentage of participants|||Number
770003|NCT00715403|Primary|Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3|All patients who had grade 3 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).|From signing the informed consent until final follow-up, up to 991 days|Treated set||percentage of participants|||Number
770004|NCT00715403|Primary|Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2|All patients who had grade 2 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).|From signing the informed consent until final follow-up, up to 991 days|Treated set||percentage of participants|||Number
770005|NCT00715403|Secondary|Progression Free Survival|"Percentage of participants that experienced progression free survival (PFS), assessed by RECIST (Response Evaluation Criteria In Solid Tumours) (version 1.0), by day 1230. Progression was defined as progressive disease (PD) or non-evaluable clinically progressive disease.
PFS was defined for patients without PD at screening as the time from first treatment with the trial drug in the previous trial until onset of PD or death, whatever comes earlier.
Patients with PD could enter the trial if they showed signs of clinical benefit. For patients with PD at screening, the RECIST assessment at screening was used as a new baseline value and PFS was the time from first treatment with the trial drug in this trial until the onset of progressive disease in this trial or death, whatever comes first."|First drug administration (in previous trial) until end of treatment, up to 1230 days|Treated set. Data for category||percentage of participants|||Number
770006|NCT00715403|Secondary|Confirmed Objective Response|Confirmed objective response assessed by RECIST (Response Evaluation Criteria In Solid Tumours) criteria (version 1.0)|Baseline until end of treatment, up to 991 days|Treated set.||percentage of participants|||Number
770007|NCT00715403|Secondary|Clinical Benefit|Clinical benefit was defined as the absence of disease progression (no PD or nonevaluable clinically progressive disease) determined by RECIST (version 1.0).|Baseline until end of treatment, up to 991 days|Treated set.||percentage of participants|||Number
770008|NCT00715403|Secondary|Unconfirmed Best Objective Response|Unconfirmed best objective response assessed by RECIST (Response Evaluation Criteria In Solid Tumours) criteria (version 1.0)|Baseline until end of treatment, up to 991 days|Treated set.||percentage of participants|||Number
770009|NCT00715403|Secondary|Unconfirmed Best Overall Response|"Unconfirmed best overall response assessed by RECIST (Response Evaluation Criteria In Solid Tumours) criteria (version 1.0).
PD = Progressive disease."|Baseline until end of treatment, up to 991 days|Treated set.||percentage of participants|||Number
770010|NCT00715403|Secondary|Pre-dose Concentration of Nintedanib in Plasma at Steady-state (Cpre,ss)|Cpre,ss represents the pre-dose concentration of Nintedanib in Plasma at steady-state at day 29|Just before drug administration every 28±7 days after day 29|Treated set. No descriptive statistics could be calculated for the dosing groups 50 mg and 200 mg QD; 100 mg and 300 mg BID due to insufficient patients.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
770011|NCT00715403|Secondary|Clinically Relevant Abnormalities for Vital Signs|Clinically relevant abnormalities for Vital Signs (systolic blood pressure, diastolic blood pressure, and pulse rate). New abnormal findings or worsening of baseline conditions were reported as Adverse Events.|From baseline until final follow-up, up to 991 days|Treated set||percentage of participants|||Number
770012|NCT00715403|Primary|Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1|All patients who had grade 1 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).|From signing the informed consent until final follow-up, up to 991 days|Treated set||percentage of participants|||Number
770013|NCT00715741|Secondary|SpO2 Postoperatively|SpO2 is measured on room air or minimum oxygen required to keep SpO2>90% on the ward 24 hours after tracheal extubation.|24 hours after tracheal extubation|||percent saturation||Standard Deviation|Mean
770014|NCT00715741|Secondary|"Arterial Oxygen Saturation by Pulse Oximetry (SpO2)"|SpO2 measured on room air or minimum supplemental oxygen to keep SpO2>90%|45 min after tracheal extubation|||percent saturation||Standard Deviation|Mean
770015|NCT00715741|Primary|Oxygen Requirement|amount of oxygen (LPM) required to maintain SpO2 >90%|24 hours after tracheal extubation|||liters per min||Inter-Quartile Range|Median
770016|NCT00715741|Primary|Oxygen Requirement to Maintain SpO2>90%|Arterial oxygen saturation by pulse oximetry (SpO2) is measured while subject is lying quietly in the post anesthesia care unit (PACU) and breathing room air (RA). Oxygen is added 0.5 liters per min (LPM) at a time to maintain SpO2 >90%.|45 min after emergence (tracheal extubation)|||liters per minute||Inter-Quartile Range|Median
770017|NCT00715754|Primary|Estimated Fetal Weight Percentile|Estimated fetal weight percentile by 2-D ultrasound at 35 weeks gestation.|35 weeks gestation|||Percentile||Standard Deviation|Mean
770018|NCT00715754|Primary|Fetal Abdominal Circumference|Fetal abdominal circumference by 2-D ultrasound at 35 weeks gestation.|35 weeks gestation|||cm||Standard Deviation|Mean
770019|NCT00715754|Primary|Infant Adiposity at 24-72 Hours Following Birth|Adiposity as measured by air displacement plethysmography|24-72 hours following birth|||Percentage of total body weight||Full Range|Mean
770023|NCT00715793|Secondary|Progression-free Survival (PFS)|PFS was defined as the time from study entry until the documented radiological or symptomatic progression. Per RECIST v1.0 criteria (assessed by MRI or CT): Progressive Disease (PD); PD, 20% increase in the sum if target lesion or the appearance of new lesions.|Up to 42 months|||months||Full Range|Median
770024|NCT00715793|Secondary|Disease Control Rate (DCR)|Using RECIST v1.0 criteria, disease control rate (DCR) was determined by the number of participants with complete response (CR) + the number of participants with partial response (PR) + the number of participants with stable disease (SD) / the number of participants with complete response (CR) + the number of participants with partial response (PR) + the number of participants with stable disease (SD) + the number of participants with progressive disease (PD). Per RECIST v1.0 criteria (assessed by MRI or CT): Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response (PR) nor sufficient increase to to qualify for Progressive Disease (PD); PD, 20% increase in the sum if target lesion or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions.|Up to 30 months|||percentage of participants|||Number
770025|NCT00715793|Primary|Recommended Phase 2 Dose (RP2D) of DAC + TMZ|Toxicity assessments used CTCAE v3.0. Two dose levels were explored in the phase I portion of the study. A modified 3 + 3 ‘up and down’ design was used. Given the knowledge that DAC exhibits its epigenetic effects at 30-fold lower doses than at its maximum-tolerated dose (MTD), escalation of DAC to the MTD was not done.|Up to 26 months|||mg/kg DAC|||Number
770026|NCT00715793|Primary|Overall Response Rate (ORR)|Using RECIST v1.0 criteria, overall response rate (ORR) was determined by the number of participants with complete response (CR) + the number of participants with partial response (PR) / the number of participants with complete response (CR) + the number of participants with partial response (PR) + the number of participants with stable disease (SD) + the number of participants with progressive disease (PD), multiplied by 100. Per RECIST v1.0 criteria (assessed by MRI or CT): Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response (PR) nor sufficient increase to to qualify for Progressive Disease (PD); PD, 20% increase in the sum if target lesion or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions.|Up to 30 months|||percentage of participants|||Number
770027|NCT00715793|Primary|Percentage of Participants That Experienced a Dose Limiting Toxicity (DLT)|Dose-limiting toxicities (DLTs) were defined as grade 4 neutropenia or thrombocytopenia which lasts >7 days; grade 3 or 4 febrile neutropenia; grade 3 or greater non-hematological toxic effects.|Up to 26 months|Patients participating in the Phase 1 portion of the study that were treated on a standard “3+3” phase I dose-escalation design who were observed for unacceptable toxicities.||percentage of participants|||Number
770028|NCT00715884|Secondary|Percentage of Participants Who Experienced Late Stent Thrombosis (Academic Research Consortium (ARC) Definition)|Those ARC stent thromboses occurred between 31 to 360 days post-procedure are late stent thrombosis.|31-360 days post-procedure|Event specific adjusted ITT population: All randomized participants excluding those with follow-up less than 330 days and without documented specific events during the 360 days post procedure||Percentage of participants|||Number
770029|NCT00715884|Secondary|Percentage of Participants Who Experienced Early Stent Thrombosis (Academic Research Consortium (ARC) Definition)|Those ARC stent thromboses occurred between 0 and 30 days post-procedure are early stent thrombosis.|0-30 days post-procedure|Event specific adjusted ITT population: All randomized participants excluding those with follow-up less than 330 days and without documented specific events during the 360 days post procedure.||Percentage of participants|||Number
770030|NCT00715884|Secondary|Percentage of Participants Who Experienced Stent Thrombosis (Academic Research Consortium (ARC) Definition)|"Academic Research Consortium (ARC) defines STENT THROMBOSIS as consisting of the following:
DEFINITE - Angiographic or pathologic confirmation;
PROBABLE - Any unexplained death within the first 30 days or Any MI (related to documented acute ischemia and without another obvious cause) in the territory of the stent;
POSSIBLE - Any unexplained death > 30 days.
ARC Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points."|12 months post procedure|Event specific adjusted ITT population: All randomized participants excluding those with follow-up less than 330 days and without documented specific events during the 360 days post procedure||Percentage of participants|||Number
770031|NCT00715884|Secondary|Percentage of Participants Who Experienced Stent Thrombosis (Protocol Definition)|Protocol defined Stent thrombosis include both Early and Late Thrombosis. Early thrombosis is defined as composite thirty-day ischemic endpoint including death, Q-wave MI, or subabrupt closure requiring revascularization. Late thrombosis is defined as myocardial infarction occurring > 30 days after the index procedure and attributable to the target vessel with angiographic documentation (site-reported or by qualitative coronary angiography) of thrombus or total occlusion at the target site and freedom from an interim revascularization of the target vessel.|12 months post procedure|Event specific adjusted ITT population: All randomized participants excluding those with follow-up less than 330 days and without documented specific events during the 360 days post procedure||Percentage of participants|||Number
770032|NCT00715884|Secondary|Percentage of Participants Who Experienced Stroke|The stroke definition includes both hemorrhagic and non-hemorrhagic strokes.|12 months post procedure|All randomized participants who had 12 months follow-up and documented specific events||Percentage of participants|||Number
770033|NCT00715884|Secondary|Percentage of Participants Who Experienced Any Myocardial Infarction (MI)|Myocardial Infarction includes both Q-wave and WHO Non-Q Wave Myocardial Infarction events.|12 months post procedure|All randomized participants who had 12 months follow-up and documented specific events||Percentage of participants|||Number
770034|NCT00715884|Secondary|Percentage of Participants Who Died|Death incidences include both Cardiac and non-cardiac death.|12 months post procedure|All randomized participants who had 12 months follow-up and documented specific events||Percentage of participants|||Number
770035|NCT00715884|Secondary|Percentage of Participants Who Experienced Bleeding Complications|Bleeding complications include any bleeding events defined by THROMBOLYSIS IN MYOCARDIAL INFARCTION (TIMI), Global Strategies for Opening Occluded Coronary Arteries (GUSTO), and “Protocol” definitions.|12 months post procedure|All randomized participants who had 12 months follow-up and documented specific events||Percentage of participants|||Number
770036|NCT00715884|Secondary|Percentage of Participants Who Had Diabetes and Experienced Target Lesion Failure (TLF)|A Target Lesion Failure is defined as clinically-driven target lesion revascularization, target vessel myocardial infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vessel at 12 months post-procedure.|12 months post procedure|All randomized participants who had diabetes and were followed up for 12 months.||Percentage of participants|||Number
770037|NCT00715884|Secondary|Percentage of Participants Who Had Lesions of More Than 1 Vessel and Experienced Target Lesion Failure (TLF)|A Target Lesion Failure is defined as clinically-driven target lesion revascularization, target vessel myocardial infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vessel at 12 months post-procedure.|12 months post procedure|All randomized participants with lesions of more than 1 vessel and were followed for 12 months||Percentage of participants|||Number
770038|NCT00715884|Secondary|Percentage of Participants Who Experienced Major Adverse Cardiac Events (MACE)|MAJOR ADVERSE CARDIAC EVENTS (MACE) consists of death, myocardial infarction, emergent bypass surgery, and target lesion revascularization.|12 months post procedure|Event specific adjusted ITT population: All randomized participants excluding those with follow-up less than 330 days and without documented events during the 360 days post procedure||Percentage of participants|||Number
770039|NCT00715884|Secondary|Percentage of Participants Who Experienced Target Vessel Failure (TVF)|Target Vessel failure is defined as clinically-driven target lesion revascularization, target vessel myocardial infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vessel at 12 months post-procedure.|12 months post procedure|Event specific adjusted ITT population: All randomized participants excluding those with follow-up less than 330 days and without documented events during the 360 days post procedure||Percentage of participants|||Number
770040|NCT00715884|Secondary|Percentage of Participants Who Experienced Target Vessel Revascularization (TVR)|"TVR is defined as any clinically driven repeat percutaneous intervention of the target vessel or bypass surgery of the target vessel. Clinically-driven revascularizations are those in which the patient has a positive functional study, ischemic ECG changes at rest in a distribution consistent with the target vessel, or ischemic symptoms, and an in-lesion diameter stenosis 50 percent by QCA."|12 months post procedure|Event specific adjusted ITT population: All randomized participants excluding those with follow-up less than 330 days and without documented events during the 360 days post procedure||Percentage of participants|||Number
770041|NCT00715884|Secondary|Percentage of Participants Who Experienced Target Lesion Revascularization (TLR)|TLR is defined as any “clinically-driven” repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel. Clinically-driven revascularizations are those in which the patient has a positive functional study, ischemic electrocardiogram (ECG) changes at rest in a distribution consistent with the target vessel, or ischemic symptoms, and an in-lesion diameter stenosis 50 percent by QCA.|12 months post-procedure|Event specific adjusted ITT population: All randomized participants excluding those with follow-up less than 330 days and without documented events during the 360 days post procedure||Percentage of participants|||Number
770042|NCT00715884|Secondary|Percentage of Participants Who Achieved Procedure Success|Procedure success is defined as achievement of a final diameter stenosis of < 50 percent (by QCA) using any percutaneous method, without the occurrence of death, Myocardial Infarction (MI), or repeat revascularization of the target lesion during the hospital stay.|At procedure during hospital stay|Intent to Treat||Percentage of participants|||Number
770043|NCT00715884|Secondary|Percentage of Device Success - All CYPHER® Stents Included|Device success is defined as achievement of a final residual diameter stenosis of <50 percent (by QCA), using the assigned device only. If QCA was not available, the visual estimate of diameter stenosis was used. Device success was based on the following two measurements. All CYPHER® Stents were included if the final residual stenosis was <50%. Non-study CYPHER® Stents were also included.|At procedure|Intent to Treat population.||Percentage of success|Participants||Number
770044|NCT00715884|Secondary|Percentage of Device Success - Protocol Definition|Device success is defined as achievement of a final residual diameter stenosis of <50 percent (by QCA), using the assigned device only. If QCA was not available, the visual estimate of diameter stenosis was used. Device success was based on the following two measurements. Protocol definition: Only protocol-defined study stents were included.|At procedure|Intent to Treat population.||Percentage of success|Participants||Number
770045|NCT00715884|Secondary|Percentage of Lesion Success|Lesion success is defined as the attainment of < 50 percent residual stenosis (by Quantitative Coronary Angiography (QCA)) using any percutaneous method.|At procedure|ITT: All randomized participants regardless whether they received the intervention||Percentage of success|Participants||Number
770046|NCT00715884|Primary|Percentage of Participants Who Experienced Target Lesion Failure (TLF)|The primary endpoint for this study is the percentage of participants who experienced Target Lesion Failure (TLF) during the 12 months post-procedure. A TLF event is defined as clinically-driven target lesion revascularization, target vessel myocardial infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vessel at 12 months post-procedure.|12-months post-procedure|Event-specific adjusted intent to treat (ITT) population: All randomized participants excluding those with follow-up less than 330 days and without documented events during the 360 days post procedure||Percentage of participants|||Number
770047|NCT00715910|Secondary|Number of Subjects With SAEs|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the 6-month period following the primary (naïve control group) and booster vaccination|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects in the primary study with a booster vaccine administration documented, newly enrolled group administered primary vaccination at Year 5 and also had symptom sheet completed.||Subjects|||Number
770048|NCT00715910|Secondary|Number of Subjects Reporting New Onset Chronic Illness(es) (NOCIs)|Examples of NOCIs include autoimmune disorders, asthma, type 1 diabetes and allergies.|During the 6-month period following the primary (naïve control group) and booster vaccination|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects in the primary study with a booster vaccine administration documented, newly enrolled group administered primary vaccination at Year 5 and also had symptom sheet completed.||Subjects|||Number
770049|NCT00715910|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31-day (Days 0-30) following primary (naïve control group) and booster vaccination|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects in the primary study with a booster vaccine administration documented, newly enrolled group administered primary vaccination at Year 5 and also had symptom sheet completed.||Subjects|||Number
770050|NCT00715910|Secondary|Number of Subjects With Solicited General Symptoms|Solicited general symptoms assessed were fatigue, gastrointestinal symptoms (nausea, vomiting, diarrhea and/or abdominal pain), headache and temperature. Any = occurrence of any general symptoms reported irrespective of intensity grade and relationship to study vaccination. Any temperature = axillary temperature greater than or equal to (≥)37.5 degrees Celsius (°C). Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 temperature = axillary temperature above 39.0°C. Related = symptoms considered by the investigator to have a causal relationship to vaccination.|During the 4-day (Days 0-3) post primary (naïve control group) and booster vaccination|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects in the primary study with a booster vaccine administration documented, newly enrolled group administered primary vaccination at Year 5 and also had symptom sheet completed.||Subjects|||Number
770051|NCT00715910|Secondary|Number of Subjects With Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any solicited local symptom reported irrespective of intensity grade. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeter (mm).|During the 4-day (Days 0-3) post primary (naïve control group) and booster vaccination|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects in the primary study with a booster vaccine administration documented, newly enrolled group administered primary vaccination at Year 5 and also had symptom sheet completed.||Subjects|||Number
770052|NCT00715910|Secondary|Number of Subjects With Vaccine Response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies|"Vaccine response was defined as:
For initially seronegative subjects: antibody titre ≥ 1:8 at one month after vaccination For initially seropositive subjects: antibody titre at one month after vaccination ≥ 4 fold the titres before vaccination."|1 month post primary (naïve control group) and booster vaccination|Analysis was performed on the ATP cohort for immunogenicity at Month 61 which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the primary (naïve control group) or booster vaccination.||Subjects|||Number
770053|NCT00715910|Secondary|hSBA Antibody Titers|Titers are given as GMTs for the serogroups hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY respectively.|1 month post primary (naïve control group) and booster vaccination|Analysis was performed on the ATP cohort for immunogenicity at Month 61 which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the primary (naïve control group) or booster vaccination.||Titers||95% Confidence Interval|Geometric Mean
770054|NCT00715910|Secondary|Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values|The cut-off values were defined as hSBA antibody titers ≥ 1:4 and ≥ 1:8.|1 month post primary (naïve control group) and booster vaccination|Analysis was performed on the ATP cohort for immunogenicity at Month 61 which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the primary (naïve control group) or booster vaccination.||Subjects|||Number
770055|NCT00715910|Secondary|Number of Subjects With SAEs Related to Study Participation or to a Concurrent GSK Medication|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From 6 months up to 5 years following primary vaccination|Analysis was performed on Total cohort at Year 5 which included all subjects vaccinated in the primary study and who came back to the visit at Year 5.||Subjects|||Number
770056|NCT00715910|Secondary|Number of Subjects With SAEs Related to Study Participation or to a Concurrent GSK Medication|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From 6 months up to 3 years following primary vaccination|Analysis was performed on Total cohort at Year 3 which included all subjects vaccinated in the primary study and who came back to the visit at Year 3.||Subjects|||Number
770057|NCT00715910|Secondary|Number of Subjects With Serious Adverse Events (SAEs) Related to a Concurrent GSK Medication|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From 6 months up to 1 year following primary vaccination|Analysis was performed on Total cohort at Year 1 which included all subjects vaccinated in the primary study and who came back to the visit at Year 1.||Subjects|||Number
770058|NCT00715910|Secondary|Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSY, and Anti-PSW-135 Antibody Concentrations|Antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in μg/mL.|At year 1 persistence|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 1, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.||μg/mL||95% Confidence Interval|Geometric Mean
770059|NCT00715910|Secondary|Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSY, and Anti-PSW-135 Concentrations Equal to or Above the Cut-off Values|The cut-off values were defined as a concentration ≥0.3 microgram per milliliter (μg/mL) and ≥2.0 μg/mL.|At year 1 persistence|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 1, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.||Subjects|||Number
777073|NCT00770809|Secondary|Pathologic Stage in the Breast and Axilla|Stage will be determined by the American Joint Committee on Cancer (AJCC) TNM (tumor, lymph nodes, metastasis) staging system.|At time of surgery||||||
770060|NCT00715910|Secondary|hSBA Antibody Titers|Titers are given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY respectively.|At year 5 persistence|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 5, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.||Titers||95% Confidence Interval|Geometric Mean
770061|NCT00715910|Secondary|hSBA Antibody Titers|Titers are given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY respectively.|At year 3 persistence|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 3, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.||Titers||95% Confidence Interval|Geometric Mean
770062|NCT00715910|Secondary|hSBA Antibody Titers|Titers are given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY respectively.|At year 1 persistence|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 1, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.||Titers||95% Confidence Interval|Geometric Mean
770063|NCT00715910|Secondary|Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values|hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:4.|At year 5 persistence|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 5, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.||Subjects|||Number
770064|NCT00715910|Secondary|Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values|hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:4.|At year 3 persistence|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 3, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.||Subjects|||Number
770065|NCT00715910|Secondary|Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values|hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:4.|At year 1 persistence|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 1, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.||Subjects|||Number
770066|NCT00715910|Primary|Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values|hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:8.|At year 5 persistence|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 5, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.||Subjects|||Number
770067|NCT00715910|Primary|Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values|hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:8.|At year 3 persistence|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 3, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.||Subjects|||Number
770068|NCT00715910|Primary|Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers Equal to or Above the Cut-off Values|hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:8.|At year 1 persistence|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 1, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.||Subjects|||Number
770069|NCT00715949|Secondary|To Establish if Neurocognitive Deficits Exist, and to What Extent, in the Cohort of Hospitalized Pediatric Patients With Minor Traumatic Brain Injury.||study completion||||||
770070|NCT00715949|Primary|The Feasibility of Inpatient Bedside Neurocognitive Testing of Pediatric Patients With Minor Traumatic Brain Injury.|In this study, we demonstrated the feasibility of administering a previously validated, computer-based neurocognitive test battery in the inpatient setting. Participation numbers were determined by the ability of the participant to attend to and complete computerized neurocognitive testing while hospitalized with minor traumatic brain injury (MTBI).|Initial testing within 72 hours of injury and subsequent testing at approximately 2-3 weeks after injury. Subjects were offered the opportunity to also undergo testing at 3 months post-injury.|Analysis population includes only subjects who completed computerized neurocognitive tests. 120 subjects began the study, however 4 dropped out because they were unable to complete the first test and were not included in the final number of analyzed participants.||participants|||Number
770071|NCT00715962|Primary|Amount of Time Spent Out of Bed as Measured by Wireless Accelerometers|Throughout the hospital stay, both the WP and UC patient wore a triaxial accelerometer on the ipsilateral thigh and ankle. The patient’s skin was assessed regularly to assure there is no evidence of irritation. The wireless monitors were used to quantify the amount of mobility that occurs daily for each patient with researchers being blinded to the outcome.|During hospital stay|Only data from those recording days during which sensors were worn for at least 12 hours, defined as a valid day recording, were considered for final analysis. The average out of bed activity (standing or walking) duration over valid days of recording for each person was reported.||minutes/day||Standard Deviation|Mean
770366|NCT00711009|Secondary|Mean Change From Baseline in Soluble Tumor Necrosis Factor Receptor-1 (Picograms/Milliliter)|Included in measures of metabolic toxicity|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||picograms/milliliter||Standard Deviation|Mean
770072|NCT00715962|Secondary|Life-Space Assessment Score|"The UAB Study of Aging Life-Space Assessment (LSA) is a validated tool that measures mobility and function based on the distance which a person reports moving during the four weeks preceding the assessment. Life-space levels range from within one’s dwelling to beyond one’s town. A life-space composite score is calculated based on life-space level, degree of independence in achieving each level, and the frequency of attaining each level. Scores range from 0 - 120 with higher scores indicating greater community mobility."|4-6 weeks after baseline|||units on a scale||Standard Deviation|Mean
770073|NCT00715962|Primary|Falls|Patients were asked daily during hospitalization to self-report any falls|18 months|||participants|||Number
770074|NCT00716079|Secondary|Death at 90 Days||90 days|||participants|||Number
770075|NCT00716079|Primary|A Composite of Death or Dependency, With Dependency Being Defined by a Score of 3 to 5 on the Modified Rankin Scale (mRS)||90 days|In the intensive group 12 patients were alive at 90 days but missing data on mRS (required for primary outcome), and 9 patients in the guideline group||participants|||Number
770076|NCT00716092|Other Pre-specified|Exploratory Sensitivity Analysis of Plasma Glucose AUEC (0-3h) Change From Baseline at Day 28|The change from baseline reflects the day 28 FPG value minus the baseline FPG value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline FPG.|Baseline and day 28|This analysis was based upon the PD-set further restricted to patients who had a baseline and at least one on-treatment value for Plasma Glucose AUEC (0-3h).||mg*h/dL||Standard Error|Mean
770077|NCT00716092|Other Pre-specified|Exploratory Sensitivity Analysis of FPG Change From Baseline at Day 28|The change from baseline reflects the day 28 FPG value minus the baseline FPG value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline FPG.|Baseline and day 28|This analysis was based upon the PD-set further restricted to patients who had a baseline and at least one on-treatment value for FPG.||mg/dL||Standard Error|Mean
770078|NCT00716092|Other Pre-specified|Exploratory Sensitivity Analysis of GLP-1 AUEC (0-2h) Change From Baseline at Day 28|The change from baseline reflects the day 28 GLP-1 AUEC (0-2h) value minus the baseline GLP-1 AUEC (0-2h) value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline GLP-1.|Baseline and day 28|This analysis was based upon the PD-set further restricted to patients who had a baseline and at least one on-treatment value for GLP-1.||pmol*h/L||Standard Error|Mean
770079|NCT00716092|Other Pre-specified|Exploratory Sensitivity Analysis of the WMG Change From Baseline at Day 28|The change from baseline reflects the day 28 WMG value minus the baseline WMG value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline WMG.|Baseline and day 28|This analysis was based upon the PD-set further restricted to patients who had a baseline and at least one on-treatment value for WMG.||mg/dL||Standard Error|Mean
770080|NCT00716092|Secondary|Plasma Glucose Area Under Effect Curve (AUEC) (0-3h) Change From Baseline at Day 28|The change from baseline reflects the day 28 Glucose AUEC (0-3h) value minus the baseline Glucose AUEC (0-3h) value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline plasma glucose AUEC (0-3h).|Baseline and day 28|The pharmacodynamic set (PD-set) consisted of all randomised patients who were treated with at least one dose of study drug. This analysis was based upon model with only BI 1356 and Placebo, further restricted to patients who had a baseline and at least one on-treatment value for Glucose AUEC(0-3h). Sitagliptin results from model with all 3 groups.||mg*h/dL||Standard Error|Mean
770081|NCT00716092|Secondary|Fasting Plasma Glucose (FPG) Change From Baseline at Day 28|The change from baseline reflects the day 28 FPG value minus the baseline FPG value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline FPG.|Baseline and day 28|The pharmacodynamic set(PD-set) consisted of all randomised patients who were treated with at least one dose of study drug. This analysis was based upon model with only BI 1356 and Placebo groups, further restricted to patients who had a baseline and at least one on-treatment value for FPG. Sitagliptin results are from model containing all 3 groups||mg/dL||Standard Error|Mean
770082|NCT00716092|Primary|GLP-1 (Glucagon Like Peptide 1) AUEC (0-2h) (Area Under Effect Curve) Change From Baseline at Day 28|The change from baseline reflects the day 28 GLP-1 AUEC (0-2h) value minus the baseline GLP-1 AUEC (0-2h) value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline GLP-1.|Baseline and day 28|The pharmacodynamic set(PD-set) consisted of all randomised patients who were treated with at least one dose of study drug. Analysis was based upon model with only BI 1356 and Placebo groups, further restricted to patients who had a baseline and at least one ontreatment value for GLP-1. Sitagliptin results are from model containing all 3 groups.||pmol*h/L||Standard Error|Mean
770083|NCT00716092|Primary|Weighted Mean Glucose (WMG) Change From Baseline at Day 28|The change from baseline reflects the day 28 WMG value minus the baseline WMG value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication, and baseline WMG.|Baseline and day 28|The pharmacodynamic set(PD-set) consisted of all randomised patients who were treated with at least one dose of study drug. This analysis was based upon model with only BI 1356 and Placebo groups, further restricted to patients who had a baseline and at least one on-treatment value for WMG. Sitagliptin results are from model containing all 3 groups||mg/dL||Standard Error|Mean
770084|NCT00716417|Secondary|Maximum Concentration of Afatinib in Plasma at Steady State (Cmax,ss)|Cmax,ss represents the maximum concentration of afatinib in plasma at steady state|0.05hours (h) before administration and 1h, 2h, 2h 55 minutes (min), 4h, 4h 30min, 5h, 6h, 8h, 10h, 24h, 48h, 216h, 480h after administration|The pharmacokinetic analysis set includes all patients who took at least one dose of trial medication and provided at least one blood sample following drug administration. Values were excluded from descriptive statistics when a comparison with plasma concentrations in the same treatment group was impossible.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
770085|NCT00716417|Secondary|Number of Patients With Objective Response|Objective tumor response based on response evaluation criteria in solid tumors (RECIST) version 1.0. Objective response is defined as complete response (CR) and partial response (PR).|Tumor assessment were performed at screening and every 2nd cycle until end of follow up (=end of treatment + 30 days +/- 7 days)|Treated Set (TS) - TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.||Participants|||Number
770367|NCT00711009|Secondary|Mean Change From Baseline in Lactate (Millimoles/Liter)|Included in measures of metabolic toxicity|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||millimoles/liter||Standard Deviation|Mean
770086|NCT00716417|Primary|Maximum Tolerated Dose (MTD) for Regimen A and Regimen B|The MTD was determined using a standard 3 +3 dose escalation cohort design. The sample size and the number of patients who receive each dose in this design depends on the frequency of DLT at each dose level in cycle 1.|21 days|Treated Set (TS) - TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.||mg/m^2|||Number
770087|NCT00716417|Primary|Number of Participants With Dose Limiting Toxicities (DLT) in the First Cycle for the Determination of the Maximum Tolerated Dose (MTD)|Number of participants with DLT in the first cycle (21 days) for the determination of the MTD.|21 days|Treated Set (TS) - TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.||Participants|||Number
770088|NCT00716443|Secondary|Number of Participants With Tolerability Assessments Resulting in Adverse Events From Baseline to Two Days After Injection of Restylane® Into the Nasolabial Folds|Number of participants w/ tolerability assessments (erythema, edema, blanching) resulting in adverse events from Baseline to two days after injection of Restylane® into the nasolabial folds|Baseline to two days after injection of Restylane® into the nasolabial folds|Safety||participants|||Number
770089|NCT00716443|Secondary|"Number of Participants With Yes/no Answers to Question to Investigator Did the Topical Anesthetics Provide Adequate Anesthesia for the Injections of Restylane® Into the Nasolabial Folds Procedure? Day of Injection of Restylane® Into Nasolabial Folds"|"Number of participants with yes or no answers to question asked to investigator on the day of injection of Restylane® into the nasolabial folds Did the topical anesthetics provided adequate anesthesia for the injections of Restylane® into the nasolabial folds procedure?"|Day of injection of Restylane® into the nasolabial folds|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)||participants|||Number
770090|NCT00716443|Secondary|Number of Participants in Each Category of the Blinded Evaluator's Evaluation of Subject's Pain Scale Three Hours After Injection of Restylane® Into the Nasolabial Folds|Number of participants in each category of the Blinded Evaluator's Evaluation of Subject's Pain scale (0 = No pain; 1 = Slight pain; 2 = Moderate pain; 3 = Severe pain) three hours after injection of Restylane® into the nasolabial folds|three hours after injection of Restylane® into the nasolabial folds|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)||participants|||Number
770091|NCT00716443|Secondary|Number of Participants in Each Category of the Blinded Evaluator's Evaluation of Subject's Pain Scale One Hour After Injection of Restylane® Into the Nasolabial Folds|Number of participants in each category of the Blinded Evaluator's Evaluation of Subject's Pain scale (0 = No pain; 1 = Slight pain; 2 = Moderate pain; 3 = Severe pain) one hour after an injection of Restylane® into the nasolabial folds|one hour after injection of Restylane® into the nasolabial folds|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)||participants|||Number
770092|NCT00716443|Secondary|Number of Participants in Each Category of the Blinded Evaluator's Evaluation of Subject's Pain Scale Immediately After Injection of Restylane® Into the Nasolabial Folds|Number of participants in each category of the Blinded Evaluator's Evaluation of Subject's Pain scale (0 = No pain; 1 = Slight pain; 2 = Moderate pain; 3 = Severe pain) immediately after injection of Restylane® into the nasolabial folds|immediately after injection of Restylane® into the nasolabial folds|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)||participants|||Number
770093|NCT00716443|Secondary|Number of Participants in Each Category of the Blinded Evaluator's Evaluation of Subject's Pain Scale Upon First Needle Stick of Injection of Restylane® Into the Nasolabial Folds|Number of participants in each category of the Blinded Evaluator's Evaluation of Subject's Pain scale (0 = No pain; 1 = Slight pain; 2 = Moderate pain; 3 = Severe pain) upon first needle stick of an injection of Restylane® into the nasolabial folds|upon first needle stick of injection of Restylane® into the nasolabial folds|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)||participants|||Number
770094|NCT00716443|Secondary|Number of Participants in Each Category of the Investigator's Evaluation of Subject's Pain Scale Three Hours After Injection of Restylane® Into the Nasolabial Folds|Number of participants in each category of the Investigator's Evaluation of Subject's Pain scale (0 = No pain; 1 = Slight pain; 2 = Moderate pain; 3 = Severe pain) three hours after injection of Restylane® into the nasolabial folds|three hours after injection of Restylane® into the nasolabial folds|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)||participants|||Number
770095|NCT00716443|Secondary|Number of Participants in Each Category of the Investigator's Evaluation of Subject's Pain Scale One Hour After Injection of Restylane® Into the Nasolabial Folds|Number of participants in each category of the Investigator's Evaluation of Subject's Pain scale (0 = No pain; 1 = Slight pain; 2 = Moderate pain; 3 = Severe pain) one hour after injection of Restylane® into the nasolabial folds|one hour after injection of Restylane® into the nasolabial folds|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)||participants|||Number
770096|NCT00716443|Secondary|Number of Participants in Each Category of the Investigator Evaluation of the Subject's Post Procedure Pain Assessment Scale Immediately After Injection of Restylane® Into the Nasolabial Folds|Number of participants in each category of the Investigator Evaluation of the Subject's Post Procedure Pain Assessment scale (0 = No pain; 1 = Slight pain; 2 = Moderate pain; 3 = Severe pain) immediately after injection of Restylane® into the nasolabial folds immediately after injection of Restylane® into the nasolabial folds|immediately after injection of Restylane® into the nasolabial folds|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)||participants|||Number
770097|NCT00716443|Secondary|Number of Participants in Each Category of the Investigator Evaluation of the Subject's Post Procedure Pain Assessment Scale Upon First Needle Stick of Injection of Restylane® Into the Nasolabial Folds|Number of participants in each category of the Investigator Evaluation of the Subject's Post Procedure Pain Assessment scale (0 = No pain; 1 = Slight pain; 2 = Moderate pain; 3 = Severe pain) upon first needle stick of an injection of Restylane® into the nasolabial folds|Upon first needle stick of injection of Restylane® into the nasolabial folds|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)||participants|||Number
770119|NCT00716625|Primary|Number of Participants With Treatment-Related Adverse Events|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.).|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.||Participants|||Number
770098|NCT00716443|Secondary|"Number of Participants Who Answered the Question Still Speaking to the Topical Anesthetic You Had on the Right/Left Side of Your Face, Would You Recommend it to Your Friend or Family Member? 3 Hours After Injection of Restylane® Into Nasolabial Folds"|"Number of participants who answered No, Yes or No response to the question Still speaking to the topical anesthetic you had on the right/left side of your face, would you recommend it to your friend or family member? three hours after injection of Restylane® into the nasolabial folds"|three hours after injection of Restylane® into the nasolabial folds|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)||participants|||Number
770099|NCT00716443|Secondary|"Number of Participants Who Answered the Question If it Was Different Than What You Expected, Was it? Three Hours After Injection of Restylane® Into the Nasolabial Folds"|"Number of participants who answered the question If it was different than what you expected, was it? (More pain, Less pain or No response) three hours after injection of Restylane® into the nasolabial folds"|three hours after injection of Restylane® into the nasolabial folds|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)||participants|||Number
770100|NCT00716443|Secondary|"Number of Participants Who Answered the Question If You Experienced Pain, Was it What You Expected From the Injection Procedure? Three Hours After Injection of Restylane® Into the Nasolabial Folds"|"Number of participants who answered No, Yes, Had no expectations or No response to the question If you experienced pain, was it what you expected from the injection procedure? three hours after injection of Restylane® into the nasolabial folds"|three hours after injection of Restylane® into the nasolabial folds|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)||participants|||Number
770101|NCT00716443|Secondary|"Number of Participants Who Answered the Question What Level of Pain Did You Experience When You Were Injected? Three Hours After Injection of Restylane® Into the Nasolabial Folds"|"Number of participants who answered according to a scale of None, Minimal, Mild, Moderate, Severe, or No response to the question What level of pain did you experience when you were injected? three hours after injection of Restylane® into the nasolabial folds"|three hours after injection of Restylane® into the nasolabial folds|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)||participants|||Number
770102|NCT00716443|Primary|Subject's Pain Evaluation by Visual Analog Scale (VAS)Upon First Needlestick, Immediately After Injection, One Hour After Injection and Three Hours After Injection of Restylane® Into the Nasolabial Folds|Subject's pain as evaluated using a VAS scale from 0 - 10 cm (centimeters) with 0 cm being no pain and 10 cm being the worst pain imaginable upon first needlestick, immediately after injection, one hour after injection and three hours after injection of Restylane® into the nasolabial folds|upon first needlestick, immediately after injection, one hour after injection and three hours after injection of Restylane® into the nasolabial folds|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)||centimeters||Standard Deviation|Mean
770103|NCT00716456|Primary|The Maximum Tolerated Dose (MTD) of Cetuximab Given Every 2 Weeks|To determine the maximum tolerated dose (MTD) of cetuximab given every 2 weeks in patients with lung adenocarcinoma receiving erlotinib that have developed acquired resistance to erlotinib (phase I portion)|At conclusion of study, up to 24 weeks|||mg/m2 of CETUXIMAB|||Number
770104|NCT00716482|Secondary|Interobserver Agreement of B Mode Ultrasound and SWE Features|614 benign and 144 malignant breast masses.|performed on the same day, after study completion|Per protocol. One lesion was analyzed per participant. Two independent readers did a qualitative assessment of 7 image parameters (per lesion) using Kappa.||kappa statistic||95% Confidence Interval|Number
770105|NCT00716482|Secondary|Intraobserver Reliability of Quantitative SWE Measurements|614 benign and 144 malignant lesions. Each category's measurement (diameter, area, etc..) is performed 3 times. These 3 measurements are then compared with each other in order to calculate the interclass correlation coefficient.|performed on the same day, within 2 years from study start date|Per protocol. 758 masses (614 benign and 144 malignant)are analyzed. One lesion was analyzed per participant. 3 acquisitions per lesion were analyzed with the ICC method for 10 different parameters.||correlation coefficient||95% Confidence Interval|Number
770106|NCT00716482|Secondary|Qualitative Intraobserver Reproducibility of SWE Related to Homogeneity Feature|614 benign and 144 malignant breast lesions were scanned in SWE 3 consecutive times, and the similarity of the 3 images was evaluated by the investigator.|performed on the same day, within 2 years from study start date|Per protocol. One lesion was analyzed per participant.||participants|||Number
770107|NCT00716482|Primary|Estimates of Effect of Selectively Upgrading BIRADS Category 3 and Downgrading BIRADS 4a Masses Based on SWE Features. Overall Specificity and Sensitivity of BI-RADS Score Using Conventional B-mode Ultrasound vs. B-mode + Certain SWE Characteristics|"Positive reference standard = malignant cytologic or histopathologic result. Negative reference standard = BIRADS 2 lesions, BIRADS 3 lesions with benign histopathology, or a 1 year follow-up ultrasound exam showing resolved or decreased lesion size.
Conservative strategy:features of E-homogeneity, E-max and E-color were used to upgrade BIRADS 3 lesions to BIRADS 4a' or downgrade BIRADS 4a lesions to BIRADS 3'. Aggressive strategy used the same features but upgraded and downgraded more lesions.
Based on 939 lesions."|2 years|Per protocol. Analysis includes 289 malignant and 650 benign masses. One lesion was analyzed per participant.||participants|||Number
770108|NCT00716625|Other Pre-specified|Number of Participants With Treatment-Related Adverse Events Grade 3 or Higher in Common Toxicity Criteria for Adverse Events (CTCAE)|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). The severity for each adverse event was assessed according to CTCAE as follows: grade 3, severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, or disabling; grade 4, life-threatening consequences or urgent intervention indicated; grade 5, death related to adverse event.|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.||Participants|||Number
770120|NCT00716742|Primary|Change From Baseline in Bilateral Intraocular Pressure (IOP) at One Year|Change from baseline in bilateral (both eyes) IOP at the 1 year follow-up visit. IOP is a measure of the fluid pressure inside the eye. The bilateral IOP was calculated as an average between both eye's IOP. A negative number change from baseline indicates reduction in IOP (improvement).|Baseline, 1 Year|Intent-to-treat, which includes all patients who started the study and completed the one-year follow-up visit and whose data was available for this outcome measure.||Millimeters of mercury (mmHg)||Standard Deviation|Mean
770109|NCT00716625|Other Pre-specified|Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.).|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.||Participants|||Number
770110|NCT00716625|Other Pre-specified|Number of Participants With Treatment-Related Serious Adverse Events|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. A treatmen-trelated serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.).|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.||Participants|||Number
770111|NCT00716625|Secondary|Numbers of Participants With Treatment-Related Adverse Events Corresponded to Items for Priority Investigation|The following adverse events were defined as items for priority investigation : (1) lung disorder including interstitial pneumonia, (2) bone marrow depression including platelets decreased, white blood cell decreased, and anaemia, (3) haemorrhage including those due to tumor degeneration or shrinkage, (4) cardiac function disturbance including QT interval prolonged and left ventricular ejection fraction decreased, (5) dysfunction adrenal, (6) pancreatic dysfunction including lipase increased, (7) thyroid function decreased, (8) cutaneous symptoms (hand and foot syndrome), (9) serious infections, (10) rhabdomyolysis, myopathy, and (11) reversible posterior leukoencephalopathy syndrome (RPLS). Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.).|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.||Participants|||Number
770112|NCT00716625|Secondary|Number of Participants With Treatment-Related Adverse Events Who Were Under Long-Term Treatment|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). The long-term treatment was defined as the treatment continued more than 24 weeks.|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.||Participants|||Number
770113|NCT00716625|Secondary|Number of Participants With Treatment-Related Adverse Events Who Used Concomitant Cytochrome P450 3A4 (CYP3A4) Inhibitors|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). A total of 38 drugs including tofisopam, bromocriptin mesilate, and fluvoxamine maleate were defined as CYP3A4 inhibitors.|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.||Participants|||Number
770114|NCT00716625|Secondary|Number of Participants With Treatment-Related Adverse Events Who Had Renal Impairment|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Renal impairment referred not to transient laboratory test value abnormalities, but to the events that were clinically noteworthy and required follow-up.|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.||Participants|||Number
770115|NCT00716625|Secondary|Number of Participants With Treatment-Related Adverse Events Who Had Hepatic Impairment|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Hepatic impairment referred not to transient laboratory test value abnormalities, but to the events that were clinically noteworthy and required follow-up.|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.||Participants|||Number
770116|NCT00716625|Secondary|Number of Participants With Treatment-Related Adverse Events in Elderly Population|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Elderly population was defined as the participants who aged 65 or older.|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.||Participants|||Number
770117|NCT00716625|Secondary|Number of Participants With Treatment-Related Adverse Events in Pediatric Population|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Pediatric population was defined as the participants who aged younger than 15, and adult population was defined as those aged 15 or older.|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.||Participants|||Number
770118|NCT00716625|Primary|Objective Response Rate|Percentage of participants with objective response per Response Evaluation Criteria In Solid Tumors Criteria (RECIST V1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR),>=30% decrease in the sum of the longest diameter of target lesion; Overall Response(OR) = CR + PR. The result was presented along with the corresponding exact 2-sided 95% confidence interval (CI).|MAX 2 Years|Efficacy analysis set comprised of participants in safety analysis set who had efficacy evaluation.||Percentage of participants||95% Confidence Interval|Number
770121|NCT00716807|Primary|Pain Intensity as Measured on a Visual Analogue Scale (VAS) Ranging From Zero to 100.||20 minute intervals for three hours.|Co-investigators have spent many hours with computer-support personnel trying to locate data on the deceased investigators' computer, but could find nothing other than the gender and treatment assignment for 46 enrolled participants.|||||
770122|NCT00716820|Other Pre-specified|Number of Participants With Treatment-Related Adverse Events Grade 3 or Higher in Common Toxicity Criteria for Adverse Events (CTCAE)|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). The severity for each adverse event was assessed according to CTCAE as follows: grade 3, severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, or disabling; grade 4, life-threatening consequences or urgent intervention indicated; grade 5, death related to adverse event.|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.||Participants|||Number
770123|NCT00716820|Other Pre-specified|Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.).|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.||Participants|||Number
770124|NCT00716820|Other Pre-specified|Number of Participants With Treatment-Related Serious Adverse Events|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. A treatmen-trelated serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.).|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.||Participants|||Number
770125|NCT00716820|Secondary|Numbers of Participants With Treatment-Related Adverse Events Corresponded to Items for Priority Investigation|The following adverse events were defined as items for priority investigation : (1) lung disorder including interstitial pneumonia, (2) bone marrow depression including platelets decreased, white blood cell decreased, and anaemia, (3) haemorrhage including those due to tumor degeneration or shrinkage, (4) cardiac function disturbance including QT interval prolonged and left ventricular ejection fraction decreased, (5) dysfunction adrenal, (6) pancreatic dysfunction including lipase increased, (7) thyroid function decreased, (8) cutaneous symptoms (hand and foot syndrome), (9) serious infections, (10) rhabdomyolysis, myopathy, and (11) reversible posterior leukoencephalopathy syndrome (RPLS). Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.).|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.||Participants|||Number
770126|NCT00716820|Secondary|Number of Participants With Treatment-Related Adverse Events Who Were Under Long-Term Treatment|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). The long-term treatment was defined as the treatment continued more than 24 weeks.|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.||Participants|||Number
770127|NCT00716820|Secondary|Number of Participants With Treatment-Related Adverse Events Who Used Concomitant Cytochrome P450 3A4 (CYP3A4) Inhibitors|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). A total of 38 drugs including tofisopam, bromocriptin mesilate, and fluvoxamine maleate were defined as CYP3A4 inhibitors.|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.||Participants|||Number
770128|NCT00716820|Secondary|Number of Participants With Treatment-Related Adverse Events Who Had Renal Impairment|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Renal impairment referred not to transient laboratory test value abnormalities, but to the events that were clinically noteworthy and required follow-up.|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.||Participants|||Number
770129|NCT00716820|Secondary|Number of Participants With Treatment-Related Adverse Events Who Had Hepatic Impairment|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Hepatic impairment referred not to transient laboratory test value abnormalities, but to the events that were clinically noteworthy and required follow-up.|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.||Participants|||Number
770130|NCT00716820|Secondary|Number of Participants With Treatment-Related Adverse Events in Elderly Population|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Elderly population was defined as the participants who aged 65 or older.|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.||Participants|||Number
770131|NCT00716820|Secondary|Objective Response Rates by Platelet - Derived Growth Factor Receptor Alpha (PDGFRα) Mutation Status|Percentage of participants with objective response based assessment of CR or confirmed PR according to RECIST. Objective response rates by PDGFRα mutation status were calculated according to RECIST and were presented along with the corresponding exact 2-sided 95% CIs.|MAX 2 Years|Efficacy analysis set comprised of participants in safety analysis set who had efficacy evaluation.||Percentage of participants||95% Confidence Interval|Number
778128|NCT00774163|Secondary|Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Myalgia Reported||Day 0 through 6 weeks after Day 0|||days with symptom reported|days of observation||Number
770132|NCT00716820|Secondary|Objective Response Rates by c-Kit Mutation Status|Percentage of participants with objective response based assessment of CR or confirmed PR according to RECIST. Objective response rates by c-kit mutation status were calculated according to RECIST and were presented along with the corresponding exact 2-sided 95% CIs.|MAX 2 Years|Efficacy analysis set comprised of participants in safety analysis set who had efficacy evaluation.||Percentage of participants||95% Confidence Interval|Number
770133|NCT00716820|Secondary|Objective Response Rates by KIT Expression Status|Percentage of participants with objective response based assessment of CR or confirmed PR according to RECIST. Objective response rates by KIT expression status were calculated according to RECIST and were presented along with the corresponding exact 2-sided 95% CIs.|MAX 2 Years|Efficacy analysis set comprised of participants in safety analysis set who had efficacy evaluation.||Percentage of participants||95% Confidence Interval|Number
770134|NCT00716820|Primary|Objective Response Rate|Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). The result was presented along with the corresponding exact 2-sided 95% confidence interval (CI).|MAX 2 Years|Efficacy analysis set comprised of participants in safety analysis set who had efficacy evaluation.||Percentage of participants||95% Confidence Interval|Number
770135|NCT00716820|Primary|Number of Participants With Treatment-Related Adverse Events|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.).|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.||Participants|||Number
770136|NCT00716859|Secondary|Percentage of Participants Discontinuing Therapy Due to a Drug-related Adverse Experience|An investigator’s causality assessment was the determination of whether there existed a reasonable possibility that the investigational product caused or contributed to an adverse event (AE). If the investigator did not know whether or not investigational product caused the event, then the event was handled as “related to investigational product” for reporting purposes.|Baseline through Week 12|Intent to treat (ITT) population: all participants who were randomized into the study and received at least 1 dose of study medication.||Percentage of particpants|||Number
770137|NCT00716859|Secondary|Percentage of Participants With Greater Than or Equal to (≥) 15% IOP Reduction From Baseline at Both Weeks 4 and 12|Participants with ≥15% IOP reduction from baseline at both Week 4 and Week 12. Calculated as (post baseline IOP minus baseline IOP) divided by IOP, multiplied by 100%. IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.|Baseline, Week 4, and Week 12|Evaluable participants in PP||Percentage of participants||95% Confidence Interval|Number
770138|NCT00716859|Secondary|Mean IOP at Week 12|IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.|Week 12|Evaluable participants in PP||mmHg||Standard Deviation|Mean
770139|NCT00716859|Secondary|Mean IOP at Week 4|IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.|Week 4|Evaluable participants in PP||mmHg||Standard Deviation|Mean
770140|NCT00716859|Secondary|Mean IOP at Week 1|IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.|Week 1|PP||mmHg||Standard Deviation|Mean
770141|NCT00716859|Secondary|Mean IOP at Baseline|IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.|Baseline|PP||mmHg||Standard Deviation|Mean
770142|NCT00716859|Secondary|Reduction From Baseline in Mean IOP at Week 12 (Observed)|Calculated as Baseline IOP minus Week 12 IOP (observed). IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.|Baseline, Week 12|Evaluable participants in PP||mmHg||Standard Error|Least Squares Mean
770143|NCT00716859|Secondary|Reduction From Baseline in Mean IOP at Week 4|Calculated as Baseline IOP minus Week 4 IOP (observed). IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.|Baseline, Week 4|Evaluable participants in PP||mmHg||Standard Error|Least Squares Mean
770144|NCT00716859|Secondary|Reduction From Baseline in Mean IOP at Week 1|Calculated as Baseline IOP minus Week 1 IOP (observed). IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.|Baseline, Week 1|PP||mmHg||Standard Error|Least Squares Mean
770181|NCT00717093|Secondary|Number of Subjects With 7-day Point Prevalence (PP) of Abstinence at the End of Treatment (Week 12) and at the End of Study (Week 26)|Number of subjects at Week 12 and Week 26 reporting no use of nicotine-containing products in the last 7 days and confirmed salivary cotinine <= 15 ng/mL.|Week 12, Week 26|ITT||participants|||Number
778129|NCT00774163|Secondary|Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Diarrhea Reported||Day 0 through 6 weeks after Day 0|||days with symptom reported|days of observation||Number
770145|NCT00716859|Primary|Reduction From Baseline in Mean IOP at Week 12, Last Observation Carried Forward (LOCF)|Calculated as Baseline IOP minus Week 12 IOP, LOCF. IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were less than or equal to (≤) 2 millimeters of mercury (mmHg) of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.|Baseline, Week 12|Per Protocol (PP) Population: participants with no major protocol violations who received at least 1 week of study medication and had at least Week 1 IOP measurements. LOCF.||mmHg||Standard Error|Least Squares Mean
770146|NCT00716963|Secondary|The Magnitude of Allergen-induced Airway Hyperresponsiveness (Methacholine PC20) and Inflammation (Sputum Eosinophils)||24 hours methacholine and sputum||||||
770147|NCT00716963|Secondary|The Magnitude of Allergen-induced Airway Hyperresponsiveness (Methacholine PC20) and Inflammation (Sputum Eosinophils)||sputum @ 7 hours||||||
770148|NCT00716963|Secondary|The Magnitude of Allergen-induced Airway Hyperresponsiveness (Methacholine PC20) and Inflammation (Sputum Eosinophils).||Before inhalation both evaluations (0 hours)||||||
770149|NCT00716963|Primary|The Magnitude of the Late Asthmatic Response, Expressed as a Percentage Fall in FEV1.||7 hours after challenge|Instead of re-listing participant flow, data was taken from each subject arm and re-listed here as the 3 arms each subject underwent.||percentage fall FEV1||Standard Deviation|Mean
770150|NCT00716963|Primary|The Magnitude of the Early Asthmatic Response, Expressed as a Percentage Fall in FEV1.||Before inhalation 3 hours|Instead of re-listing participant flow, data was taken from each subject arm and re-listed here as the 3 arms each subject underwent.||percentage fall FEV1||Standard Deviation|Mean
770160|NCT00717041|Secondary|Depression and Cognitive Impairment at 2 Weeks|For the individuals who are able to be contacted in 2 weeks, how many still test positive for depression and cognitive impairment.|2 weeks|||participants||95% Confidence Interval|Number
770161|NCT00717041|Primary|Participants With Anxiety by Generalized Anxiety Disorder - 7|Participants with anxiety as measured by the Generalized Anxiety Disorder - 7, with a score greater than or equal to 10.|2 hours|||participants|||Number
770162|NCT00717041|Primary|Participants With Cognitive Impairment by Six Item Screener|Number of participants with cogintiive impairment as measured by the Six Item Screener, with greater than 2 questions incorrect|2 hours|||participants|||Number
770163|NCT00717041|Primary|Participants With Depression by Patient Health Questionnaire - 9|Number of participants with depression as measured by the Patient Health Questionnaire - 9, with a score of greater than or equal to 10.|2 hours|||participants|||Number
770164|NCT00717054|Secondary|Need for Antiemetic Medication||24 hours postoperatively|||participants|||Number
770165|NCT00717054|Secondary|Total Vomiting||24 hours postoperatively|||participants|||Number
770166|NCT00717054|Secondary|Number of Participants With Nausea and Vomiting in PACU||Postoperatively, up to 2 hours|||participants|||Number
770167|NCT00717054|Primary|Number of Participants With Nausea and Vomiting||24 hours postoperatively|||participants|||Number
770182|NCT00717093|Secondary|Number of Subjects With Long Term Quit Rate (LTQR) of Smokeless Tobacco|Number of subjects who were responders for the primary endpoint (4-week CQR for Weeks 9 through 12) and who had no more than 6 cumulative days of using nicotine containing products from Week 12 through Week 26.|Week 26|ITT||participants|||Number
770183|NCT00717093|Secondary|Number of Subjects With Continuous Abstinence (CA) of Smokeless Tobacco Use|Number of subjects who remainded abstinent from the period defined as start of the primary endpoint (Week 9) through the end of follow up (Week 26) by reporting no use of nicotine-containing products and confirmed salivary cotinine <= 15 ng/mL.|Week 9 through 12, Week 26|ITT||participants|||Number
770168|NCT00717067|Secondary|Safety and Tolerability of Maraviroc in the Absence and Presence of a Potent CYP3A4 Inhibitor in Subjects With Various Degrees of Renal Impairment or Undergoing Hemodialysis: Number of Subjects With Maximum EGC QTC, QTCB and QTCF Intervals|Single 12-lead ECG: number of subjects with maximum QTC interval, maximum QTCB interval (Bazett's correction), and maximum QTCF interval (Friderica's correction) measured in milliseconds (msec); range: 450 to <480 msec, 480 to <500 msec, and >500 msec. Maximum QTC interval increase from Baseline; citeria: change = ≥ 30 msec to < 60 msec, and change = ≥ 60 msec.|Normal renal function: screening, Day -3 and Day -1; normal renal function, mild and moderate RI: Day 7 to Day 9 and follow-up; severe RI: screening, Day 1, Day 3, Day 4, and follow-up; ESRD: screening, Day 1, Day 3, Day 4, and follow-up|Safety analysis set: all subjects who received study medication.||subjects|||Number
770169|NCT00717067|Secondary|Safety and Tolerability of Maraviroc in the Absence and Presence of a Potent CYP3A4 Inhibitor in Subjects With Various Degrees of Renal Impairment or Undergoing Hemodialysis: Number of Subjects With Pulse Rate < 40 and > 120 Beats Per Minute|Number of subjects with pulse rate < 40 beats per minute (BPM), number of subjects with pulse rate > 120 BPM.|Normal renal function: screening, Day -3 to Day -1; normal, mild and moderate RI: Day 7 to Day 10 and follow-up; severe RI: Day 1 to Day 4 and follow-up; ESRD: Day 1, Day 4, and follow-up|Safety analysis set: all subjects who received study medication.||bpm|||Number
770170|NCT00717067|Secondary|Safety and Tolerability of Maraviroc in the Absence and Presence of a Potent CYP3A4 Inhibitor in Subjects With Various Degrees of Renal Impairment or Undergoing Hemodialysis: Number of Subjects With Maximum Increase and Decrease in Supine Blood Pressure|Number of subjects with absolute values of supine systolic blood pressure (BP) measured in millimeters of mercury (mm/Hg), range: <90 mmHg; and supine diastolic blood pressure, range: <50 mmHg. Number of subjects with a maximum increase and decrease from Baseline in supine systolic BP ≥ 30 mmHg. Number of subjects with a maximum increase and decrease from Baseline in supine diastolic BP ≥ 20 mmHg.|Normal renal function: screening, Day -3 to Day -1; normal, mild and moderate RI: Day 7 to Day 10 and follow-up; severe RI: Day 1 to Day 4 and follow-up; ESRD: Day 1, Day 4, and follow-up|Safety analysis set: all subjects who received study medication. BL: Baseline.||subjects|||Number
770171|NCT00717067|Secondary|Hemodialysis Clearance of Maraviroc (MVC) in Subjects With End Stage Renal Disease (ESRD) Undergoing Hemodialysis: CLdD|CLdD: dialysate clearance before dialysis; measured in milliliters per minute.|Before dialysis|Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest.||mL/min||Standard Deviation|Geometric Mean
770172|NCT00717067|Secondary|Derivation of Renal Clearance in Subjects With Normal, Mild, Moderate and Severe Renal Function: Ae|Ae: amount of drug excreted unchanged in the urine; measured in milligrams (mg).|Hour 0 (prior to MVC dosing [single dose] or prior to last MVC dose [multiple dose]) to 72 hours post-dose ; hours 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72.|Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest.||mg||Standard Deviation|Mean
770173|NCT00717067|Secondary|Renal Clearance (CLR) in Subjects With Normal, Mild, Moderate and Severe Renal Function|Renal clearance (CLR) measured in milliliters per minute (mL/min).|Hour 0 (prior to MVC dosing [single dose] or prior to last MVC dose [multiple dose]) to 72 hours post-dose ; hours 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72.|Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest.||mL/min||Standard Deviation|Geometric Mean
770174|NCT00717067|Secondary|Half-life (t1/2)|Elimination half-life (t1/2) measured in hours: time required for half the quantity of maraviroc to be metabolized or eliminated by normal biological processes.|Pre-dose, post-dose hours 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72.|Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest.||hour||Standard Deviation|Mean
770175|NCT00717067|Secondary|Time of First Occurrence (Tmax)|Time (hours) of first occurrence (Tmax); time after dosing when Cmax (maximum plasma concentration) occured.|Pre-dose, post-dose hours 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72.|Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest.||hours||Full Range|Median
770176|NCT00717067|Secondary|Area Under the Time Curve From 0 to Infinity (AUCinf)|Area under the plasma concentration-time profile from time zero to the time infinate in subjects who received single dose treatment; measured in nanograms * hour divided by millilters (ng*hr/mL).|Pre-dose, post-dose hours 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72|Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest. AUC infinity was not determined for subjects in the multiple dose treatment groups.||ng*hr/mL||Standard Deviation|Geometric Mean
770177|NCT00717067|Secondary|Plasma Protein Binding|Percent protein binding (protein unbound maraviroc (MVC) fraction [percent free]) was determined by rapid equilibrium dialysis. Percent free = 100 - percent bound.|2 hours post-dose; normal Day -3 and Day 7; mild moderate: Day 7; severe and ESRD: Day 1|Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest.||percent free|||Number
770178|NCT00717067|Primary|Maximum Observed Plasma Concentration (Cmax)|Maximum observed plasma concentration (Cmax) within the dosing interval; measured in nanograms per milliliter (ng/mL).|Pre-dose, post-dose hours 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72.|Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest.||ng/mL||Standard Deviation|Geometric Mean
770179|NCT00717067|Primary|AUCtau|AUCtau: area under the plasma concentration-time profile from time zero to the end of the dosing interval (tau); measured in nanograms * hours divided by milliliters (ng.hr/mL).|Pre-dose, post-dose hours 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72.|Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest. AUCtau for end stage renal disease subjects was not determined.||ng*hr/mL||Standard Deviation|Geometric Mean
770180|NCT00717067|Primary|Area Under the Plasma Concentration Time-curve From Zero to the Last Measured Concentration (AUClast)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) measured in nanograms * hour divided by milliliters (ng*hr/mL).|Pre-dose, post-dose hours 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72.|Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest.||ng*hr/mL||Standard Deviation|Geometric Mean
778130|NCT00774163|Secondary|Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Malaise Reported||Day 0 through 6 weeks after Day 0|||days with symptom reported|days of observation||Number
770184|NCT00717093|Primary|Number of Subjects With a 4 Week Continuous Quit Rate (CQR) From Smokeless Tobacco|"Number of subjects who reported no use of nicotine-containing products by answering No to the nicotine use inventory (NUI) question: Has the subject used any nicotine-containing products in the last 7 days (Week 9) or since last study visit (Week 10 through 12) and confirmed salivary cotinine <= 15 ng/mL."|Weeks 9 through 12|Intent to treat (ITT)||participants|||Number
770185|NCT00717197|Primary|Percentage of Participants With Progression-free Survival.|Gadolinium-contrasted MRIs were used to assess radiographic response every 2 cycles (~6 weeks). Tumor progression was defined by increasing tumor size, new areas of tumor, or unequivocal neurologic deterioration.|From date of first dose of study drug until month 6.|Per protocol||percentage of participants with PFS6||95% Confidence Interval|Number
770186|NCT00717236|Secondary|Change From Baseline in Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS) at Week 28|Change from Baseline in PhGADA-VAS (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as the value at Week 28 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).|Baseline, Week 28|Of the 954 subjects in the Open Label Set (OLS) 848 had observed values at Week 28 and Baseline and are included in this analysis||mm||Standard Error|Least Squares Mean
770187|NCT00717236|Secondary|Change From Baseline in Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS) at Week 28|Change from Baseline in PtGADA-VAS (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as the value at Week 28 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).|Baseline, Week 28|Of the 954 subjects in the Open Label Set (OLS) 857 had observed values at Week 28 and Baseline and are included in this analysis||mm||Standard Error|Least Squares Mean
770188|NCT00717236|Secondary|Change From Baseline in Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS) at Week 28|Change from Baseline in PAAP-VAS (0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain) is computed as the value at Week 28 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).|Baseline, Week 28|Of the 954 subjects in the Open Label Set (OLS) 856 had observed values at Week 28 and Baseline and are included in this analysis||mm||Standard Error|Least Squares Mean
770189|NCT00717236|Secondary|Change From Baseline in C-reactive Protein (CRP) at Week 28|Change from Baseline in CRP (mg/L) is computed as the ratio of the value at Week 28 divided by Baseline value. A ratio less then 1 indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).|Baseline, Week 28|Of the 954 subjects in the Open Label Set (OLS) 851 had observed values at Week 28 and Baseline and are included in this analysis||mg/L||95% Confidence Interval|Least Squares Mean
770190|NCT00717236|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 28|HAQ-DI is derived based on the mean of individual scores in 8 categories of daily living actives (using 20 questions). Each question is scored 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do). Change from baseline is computed as the value at Week 28 minus the baseline value. A negative value in change from baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).|Baseline, Week 28|Of the 954 subjects in the Open Label Set (OLS) 854 had observed values at Week 28 and Baseline and are included in this analysis||units on a scale||Standard Error|Least Squares Mean
770191|NCT00717236|Secondary|Change From Baseline in Swollen Joint Count (SJC) at Week 28|SJC is calculated based on swelling response of 28 joints. SJC possible values range from 0 to 28. A lower SJC indicates less joint swelling. Change from baseline is computed as the value at Week 28 minus the baseline value. A negative value in change from baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).|Baseline, Week 28|Of the 954 subjects in the Open Label Set (OLS) 861 had observed values at Week 28 and Baseline and are included in this analysis.||units on a scale||Standard Error|Least Squares Mean
770192|NCT00717236|Secondary|Change From Baseline in Tender Joint Count (TJC) at Week 28|TJC is calculated based on tenderness response of 28 joints. TJC possible values range from 0 to 28. A lower TJC indicates less joint tenderness. Change from Baseline is computed as the value at Week 28 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).|Baseline, Week 28|Of the 954 subjects in the Open Label Set (OLS) 861 had observed values at Week 28 and Baseline and are included in this analysis.||units on a scale||Standard Error|Least Squares Mean
770193|NCT00717236|Secondary|CDAI (Clinical Disease Activity Index) Remission (≤2.8) at Week 28|CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient’s Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity. This analysis was carried out using imputation.|Week 28|Since imputation was used, all 954 subjects from the Open Label (OL) Set are included in this analysis||percentage of subjects|||Number
770194|NCT00717236|Secondary|SDAI (Simplified Disease Activity Index) Remission (≤3.3) at Week 28|SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient’s Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity. This analysis was carried out using imputation.|Week 28|Since imputation was used, all 954 subjects from the Open Label (OL) Set are included in this analysis||percentage of subjects|||Number
770195|NCT00717236|Secondary|DAS28(CRP) [Disease Activity Score-28 (C-reactive Protein)] Remission (<2.6) at Week 28|DAS28(CRP) is calculated using tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/L), and Patient’s Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in mm). A lower score indicates less disease activity. This analysis was carried out using imputation.|Week 28|Since imputation was used, all 954 subjects from the Open Label (OL) Set are included in this analysis||percentage of subjects|||Number
770368|NCT00711009|Secondary|Mean Change From Baseline in Interleukin-6 (Nanograms/Liter)|Included in measures of metabolic toxicity|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||nanograms/liter||Standard Deviation|Mean
770196|NCT00717236|Secondary|Change From Baseline in CDAI (Clinical Disease Activity Index) at Week 28|CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient’s Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity. Change from Baseline is computed as value at Week 28 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).|Baseline, Week 28|Of the 954 subjects in the Open Label Set (OLS) 840 had observed values at Week 28 and Baseline and are included in this analysis.||units on a scale||Standard Error|Least Squares Mean
770197|NCT00717236|Secondary|Change From Baseline in SDAI (Simplified Disease Activity Index) at Week 28|SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient’s Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity. Change from Baseline is computed as the value at Week 28 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).|Baseline, Week 28|Of the 954 subjects in the Open Label Set (OLS) 828 had observed values at Week 28 and Baseline and are included in this analysis.||units on a scale||Standard Error|Least Squares Mean
770198|NCT00717236|Secondary|Change From Baseline in DAS28(CRP) [Disease Activity Score-28 (C-reactive Protein)] at Week 28|DAS28(CRP) is calculated using tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/L), and Patient’s Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in mm). A lower score indicates less disease activity. Change from Baseline is computed as the value at Week 28 minus Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).|Baseline, Week 28|Of the 954 subjects in the Open Label Set (OLS) 840 had observed values at Week 28 and Baseline and are included in this analysis.||units on a scale||Standard Error|Least Squares Mean
770199|NCT00717236|Secondary|American College of Rheumatology 70% (ACR70) Response at Week 28|ACR70 responders are subjects with at least 70% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS). This analysis was carried out using imputation.|Baseline, Week 28|Since imputation was used, all 954 subjects from the Open Label (OL) Set are included in this analysis||percentage of subjects|||Number
770200|NCT00717236|Secondary|American College of Rheumatology 50% (ACR50) Response at Week 28|ACR50 responders are subjects with at least 50% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS). This analysis was carried out using imputation.|Baseline, Week 28|Since imputation was used, all 954 subjects from the Open Label (OL) Set are included in this analysis||percentage of subjects|||Number
770201|NCT00717236|Secondary|American College of Rheumatology 20% (ACR20) Response at Week 28|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS). This analysis was carried out using imputation.|Baseline, Week 28|Since imputation was used, all 954 subjects from the Open Label (OL) Set are included in this analysis||percentage of subjects|||Number
770202|NCT00717236|Secondary|European League Against Rheumatism (EULAR) Response at Week 12|EULAR response (good response, moderate response, or no response) is defined based on the present value and improvement from baseline in DAS28(CRP) [Disease Activity Score-28 (C-reactive protein)].|Baseline, Week 12|All 1063 subjects in the Full Analysis Set (FAS) are included in this analysis.||percentage of subjects|||Number
770203|NCT00717236|Secondary|Time to Sustained American College of Rheumatology 20% (ACR20) Response|The time from randomization to sustained ACR20 response at 2 consecutive visits (at the latest on Week 12).|Baseline up to Week 12|All 1063 subjects in the Full Analysis Set (FAS) are included in this analysis.||percentage of subjects|||Number
770204|NCT00717236|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS) at Week 12|Change from Baseline in PhGADA-VAS (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS) 1029 (827 CZP, 202 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.||mm||Standard Deviation|Mean
770205|NCT00717236|Secondary|Change From Baseline in Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS) at Week 12|Change from Baseline in PtGADA-VAS (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS) 1038 (835 CZP, 203 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.||mm||Standard Deviation|Mean
770206|NCT00717236|Secondary|Change From Baseline in Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS) at Week 12|Change from Baseline in PAAP-VAS (0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain) is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS) 1038 (835 CZP, 203 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.||mm||Standard Deviation|Mean
770207|NCT00717236|Secondary|Change From Baseline in C-reactive Protein (CRP) at Week 12|Change from baseline in CRP (mg/L) is computed as the ratio of Week 12 value divided by baseline value. A ratio less then 1 indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS) 1046 (841 CZP, 205 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.||mg/L||Geometric Coefficient of Variation|Geometric Mean
770208|NCT00717236|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 12|HAQ-DI is derived based on the mean of individual scores in 8 categories of daily living actives (using 20 questions). Each question is scored 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do). Change from baseline is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS) 1029 (826 CZP, 203 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.||units on a scale||Standard Deviation|Mean
770209|NCT00717236|Secondary|Change From Baseline in Swollen Joint Count (SJC) at Week 12|SJC is calculated based on swelling response of 28 joints. SJC possible values range from 0 to 28. A lower SJC indicates less joint swelling. Change from baseline is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS) 1043 (838 CZP, 205 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.||units on a scale||Standard Deviation|Mean
770210|NCT00717236|Secondary|Change From Baseline in Tender Joint Count (TJC) at Week 12|TJC is calculated based on tenderness response of 28 joints. TJC possible values range from 0 to 28. A lower TJC indicates less joint tenderness. Change from baseline is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS) 1043 (838 CZP, 205 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.||units on a scale||Standard Deviation|Mean
770211|NCT00717236|Secondary|CDAI (Clinical Disease Activity Index) Remission (≤2.8) at Week 12|CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient’s Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity.|Week 12|All 1063 subjects in the Full Analysis Set (FAS) are included in this analysis.||percentage of subjects|||Number
770212|NCT00717236|Secondary|SDAI (Simplified Disease Activity Index) Remission (≤3.3) at Week 12|SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient’s Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity.|Week 12|All 1063 subjects in the Full Analysis Set (FAS) are included in this analysis.||percentage of subjects|||Number
770213|NCT00717236|Secondary|DAS28(CRP) [Disease Activity Score-28 (C-reactive Protein)] Remission (<2.6) at Week 12|DAS28(CRP) is calculated using tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/L), and Patient’s Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in mm). A lower score indicates less disease activity.|Week 12|All 1063 subjects in the Full Analysis Set (FAS) are included in this analysis.||percentage of subjects|||Number
770214|NCT00717236|Secondary|Change From Baseline in CDAI (Clinical Disease Activity Index) at Week 12|CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient’s Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity. Change from baseline is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS) 1024 (824 CZP, 200 Placebo) are included in this analysis.||units on a scale||Standard Deviation|Mean
770215|NCT00717236|Secondary|Change From Baseline in SDAI (Simplified Disease Activity Index) at Week 12|SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient’s Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity. Change from baseline is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS) 1024 (824 CZP, 200 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.||units on a scale||Standard Deviation|Mean
770216|NCT00717236|Secondary|Change From Baseline in DAS28(CRP) [Disease Activity Score-28 (C-reactive Protein)] at Week 12|DAS28(CRP) is calculated using tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/L), and Patient’s Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in mm). A lower score indicates less disease activity. Change from baseline is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS) 1037(834 CZP, 203 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.||units on a scale||Standard Deviation|Mean
770217|NCT00717236|Secondary|American College of Rheumatology 70% (ACR70) Response at Week 12.|ACR70 responders are subjects with at least 70% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS)|Baseline, Week 12|All 1063 subjects in the Full Analysis Set (FAS) are included in this analysis.||percentage of subjects|||Number
770218|NCT00717236|Secondary|American College of Rheumatology 50% (ACR50) Response at Week 12|ACR50 responders are subjects with at least 50% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS)|Baseline, Week 12|All 1063 subjects in the Full Analysis Set (FAS) are included in this analysis.||percentage of subjects|||Number
770219|NCT00717236|Secondary|American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects With Disease Duration ≥ 2 Years.|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS)|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS), 807 were in the disease duration greater than or equal to 2 years stratum (645 CZP, 162 Placebo) and are included in this analysis.||percentage of subjects|||Number
770220|NCT00717236|Secondary|American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects With Disease Duration < 2 Years|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS)|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS), 256 were in the disease duration less than 2 years stratum (206 CZP, 50 Placebo) and are included in this analysis.||percentage of subjects|||Number
770221|NCT00717236|Secondary|American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects Without Prior Anti-tumor Necrosis (Anti-TNF) Use|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS)|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS), 663 were in the no prior anti-tumor necrosis (anti-TNF) use stratum (531 CZP, 132 Placebo) and are included in this analysis.||percentage of subjects|||Number
770222|NCT00717236|Secondary|American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects With Prior Anti-tumor Necrosis (Anti-TNF) Use|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS)|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS), 400 were in the prior anti-tumor necrosis (anti-TNF) use stratum (320 CZP, 80 Placebo) and are included in this analysis.||percentage of subjects|||Number
770223|NCT00717236|Secondary|American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects Without Concomitant Methotrexate (MTX) Use.|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS)|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS), 331 were in the no concomitant methotrexate use stratum (262 CZP, 69 Placebo) and are included in this analysis.||percentage of subjects|||Number
770224|NCT00717236|Secondary|American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects With Concomitant Methotrexate (MTX) Use.|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS)|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS), 732 were in the concomitant methotrexate use stratum (589 CZP, 143 Placebo) and are included in this analysis.||percentage of subjects|||Number
770225|NCT00717236|Primary|American College of Rheumatology 20% (ACR20) Response at Week 12|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS)|Baseline, Week 12|All 1063 subjects (851 CZP, 212 Placebo) included in the Full Analysis Set (FAS) are included in this analysis||percentage of subjects|||Number
770226|NCT00717249|Primary|Average Contact Lens Wear Time|The Contact lens wear time for the study contact lenses was collected for each subject. The average wear time for each contact lens was reported.|6 Months|The analysis population consists of subjects that completed all study visits without a major protocol deviation.||time in hours||Full Range|Mean
770227|NCT00717249|Primary|Visual Acuity|Binocular LogMAR Visual Acuity was taken under low luminance and high contrast conditions using ETDRS acuity charts.|6 months|The analysis population consists of subjects that completed all study visits without a major protocol deviation.||LogMAR||Standard Deviation|Mean
770228|NCT00717249|Primary|Subject Reported Symptoms|"Subjects were asked Have you experienced any symptoms or problems since your last visit? at each visit and responded 'yes' or 'no' for each eye; at each visit(baseline, 2-, 4-, 12- and 26- week follow-up evaluations). If a subject responded 'yes' then the symptoms was classified into one of the four categories, Dryness, Other, Cloudy/ Blurry / Hazy, Irritation / Discomfort. The percentage of each response across all visits was reported."|6 months|The analysis population consists of subjects that completed all study visits without a major protocol deviation.||Percentage of Observations|Participants||Number
770229|NCT00717249|Primary|Slit Lamp Findings|Each subjects' eye was examined using a bio-microscope. Slit lamp findings were graded using a 5- point scale. (Grade 0, 1, 2, 3 and 4). The data was dichotomized by creating 2 groups. Eyes with Grade 3 or Grade 4; eyes with Grade 2 or lower. The number of eyes with Grade 3 or Grade 4 was reported.|6 months|The analysis population consists of subjects that completed all study visits without a major protocol deviation.||Number of Subject Eyes|Participants||Number
770230|NCT00717275|Primary|Number of Participants Who Developed Distant Brain Failure at One Year.||1 Year|Data was not analyzed.|||||
770231|NCT00717288|Secondary|Reversion to Intravenous Insulin for Failure of Glycemic Control|Number of participants who went back on intravenous insulin for failure of glycemic control.|72 hours|||participants|||Number
770232|NCT00717288|Secondary|Patients With Hypoglycemia (Defined as Glucose <65 mg/dl)|Number of patients with hypoglycemia (defined as glucose <65 mg/dl)|48 hours|Intention to treat (ITT)||participants|||Number
770233|NCT00717288|Primary|Patients With Morning (AM) Glucose Between 80-130 mg/dl on Day 2 and 3|Number of patients with a morning glucose between 80-130 mg/dl on day 2 and day 3|day 2, day 3|intention to treat (ITT)||participants|||Number
770234|NCT00717314|Secondary|Percentage of Participants Experiencing Acute Rejection, Graft Loss, Death, or a Decrease From BL in Creatinine Clearance of ≥20% at Week 52|The percentage of participants who experienced at least 1 of the following: a ≥20% decrease from BL in creatinine clearance, acute rejection, graft loss, or death 1 year after randomization.|Week 52|PP population||percentage of participants|||Number
770235|NCT00717314|Secondary|Percentage Change in Creatinine Clearance From Baseline|Creatinine clearance was calculated using the Cockcroft and Gault formula.|Weeks 16, 28, 40, and 52|PP population||percentage change from baseline||Standard Deviation|Mean
770236|NCT00717314|Secondary|Change From Baseline in Corrected Creatinine Clearance (mL/Min) at Week 52|Corrected creatinine clearance was calculated using the Cockcroft and Gault formula: For adult males, creatinine clearance in mL/min = [(140 - age in years) * (weight in kg] divided by [72 * serum creatinine in mg/dL]. For adult females, creatinine clearance in mL/min = 0.85 * [(140 - age in years) * (weight in kg)] divided by (72 * serum creatinine in mg/dL).|Week 52|PP population; number (n) = number of participants assessed for the specified parameter at a given visit.||mL/min||95% Confidence Interval|Mean
770237|NCT00717314|Secondary|Changes From Baseline in Creatinine Clearance (Milliliters Per Minute [mL/Min])|Creatinine clearance calculated using the Cockcroft and Gault formula: For adult males, creatinine clearance in mL/min equaled (=) [(140 minus (-) age in years) multiplied by (*) (weight in kilograms (kg)] divided by [72 * serum creatinine in milligrams per deciliter (mg/dL)]. For adult females, creatinine clearance in mL/min = 0.85 * [(140 - age in years) * (weight in kg)] divided by (72 * serum creatinine in mg/dL).|Baseline and Weeks 16, 28, and 40|PP population; number (n) = number of participants assessed for the specified parameter at a given visit.||mL/min||Standard Deviation|Mean
770238|NCT00717314|Secondary|Percentage of Participants With Biopsy-Proven Acute Rejection (BPAR) at Week 52|BPAR was graded according to Banff criteria.|Week 52|PP population||percentage of participants|||Number
770239|NCT00717314|Secondary|Percentage of Participants With Graft Loss or Death at Week 52|Graft loss was defined for this protocol as re-transplantion or death.|Week 52|PP population||percentage of participants|||Number
770240|NCT00717314|Primary|Percentage of Participants With Decrease in Glomerular Filtration Rate (GFR) of Greater Than 20%|The percentage of participants with a greater than 20% decrease of GFR during the 1-year period following regimen adjustment. Cockcroft and Gault formula was used for calculated creatinine clearance.|Week 52|PP population||percentage of participants|||Number
770241|NCT00717366|Secondary|Apparent Terminal Phase Half-Life (t1/2) of MIRCERA|t1/2 was defined as the time (in hours) measured (from all sample collection timepoints [as provided in timeframe]) for the serum concentration to decrease by one half. The t1/2 was calculated as natural logarithm of 2 divided by λz; where λz = terminal elimination rate constant.|Pre-dose (with 1 hour before drug administration) and 2, 48 hours post dose on Week 9, at Weeks 10, 11, and 12, pre-dose (with 1 hour before drug administration) on Week 13|PK evaluable population. Number of participants analyzed = participants evaluable for t1/2 assessments.||hours||Geometric Coefficient of Variation|Geometric Mean
770242|NCT00717366|Secondary|Time to Reach Cmax (Tmax) of MIRCERA|Tmax was defined as the time (in hours) to achieve Cmax (Cmax was defined as the highest serum concentration observed over all sample collection timepoints [as provided in timeframe]). The median time, among all participants, was reported.|Pre-dose (with 1 hour before drug administration) and 2, 48 hours post dose on Week 9, at Weeks 10, 11, and 12, pre-dose (with 1 hour before drug administration) on Week 13|PK evaluable population.||hours||Full Range|Median
770243|NCT00717366|Secondary|Area Under the Serum Concentration-Time Curve From 0 to 672 Hours (AUC0-672h) of MIRCERA|Area under the serum concentration versus time curve over 672 hours. AUC0-672h represents area under the serum concentration versus time curve from time zero to end of dosing interval (AUC0-tau).|Pre-dose (with 1 hour before drug administration) and 2, 48 hours post dose on Week 9, at Weeks 10, 11, and 12, pre-dose (with 1 hour before drug administration) on Week 13|PK evaluable population. Number of participants analyzed = participants with AUC0-672h assessment at specified time-points.||picograms*hour/milliliter (pg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
770244|NCT00717366|Secondary|Maximum Observed Serum Concentration (Cmax) of MIRCERA|Cmax was defined as the highest serum concentration observed from all sample collection timepoints (as provided in timeframe) and was averaged out among participants and reported.|Pre-dose (with 1 hour before drug administration) and 2, 48 hours post dose on Week 9, at Weeks 10, 11, and 12, pre-dose (with 1 hour before drug administration) on Week 13|Pharmacokinetic (PK) evaluable population included all enrolled participants who received at least one dose of study drug and had evaluable PK assessment. Here 'n' signifies number of participants evaluable at specified time-points.||picograms per milliliter (pg/mL)||Geometric Coefficient of Variation|Geometric Mean
770245|NCT00717366|Secondary|Change in Average Reticulocyte Count Between the Baseline and Evaluation Period|A time adjusted average baseline reticulocyte count for each individual was calculated using an AUC approach from all available reticulocyte counts taken during the baseline period (Day -20 to Day 1). The average evaluation period reticulocyte count for each individual was calculated using the same method, from all their available measurements taken during the evaluation period (Weeks 17 to 21). The change in reticulocyte count between the baseline and evaluation periods was calculated by subtracting the baseline reticulocyte count from the evaluation period reticulocyte count. Relative reticulocytes were recorded conversion to absolute values was performed.|Baseline (Day -20 to Day 1), Evaluation Period (Week 17 to Week 21)|ITT population. Reticulocyte values within 21 days after blood transfusion(s) were excluded from analysis. Here, number of participants analyzed = participants evaluable for this outcome measure and 'n' signifies number of participants evaluable at specified time-points.||10^3 cells/microliter||Standard Deviation|Mean
770246|NCT00717366|Secondary|Number of Participants With Blood Transfusions||Baseline to Week 20|ITT population.||participants|||Number
770247|NCT00717366|Secondary|Number of Participants With an Average Hb Concentration During the Evaluation Period Above, Within or Below the Range of 10-12 g/dL|The evaluation period Hb concentration was defined as the average Hb concentration from all available Hb measurements taken during the evaluation period (Week 17 to Week 21).|Evaluation Period (Week 17 to Week 21)|ITT population. Hb values within 21 days after blood transfusion(s) were excluded from analysis. Number of participants analyzed = participants with Hb concentration assessment at specified time-points.||participants|||Number
770248|NCT00717366|Secondary|Number of Participants With an Average Hb Concentration During the Evaluation Period Within ±1 g/dL of Their Baseline Hb|Baseline Hb value was defined as the average Hb concentration from all available Hb measurements taken during the baseline period (Day -20 to Day 1). The evaluation period Hb concentration was defined as the average Hb concentration from all available Hb measurements taken during the evaluation period (Week 17 to Week 21).|Evaluation Period (Week 17 to Week 21)|ITT population. Hb values within 21 days after blood transfusion(s) were excluded from analysis. Number of participants analyzed = participants with Hb concentration assessment at specified time-points.||participants|||Number
770249|NCT00717366|Primary|Change in Average Hb Concentration Between Baseline and Evaluation Period|A time adjusted average baseline Hb concentration for each individual was calculated using an area under the curve (AUC) approach from all available Hb measurements taken during the baseline period (Day -20 to Day 1). The average evaluation period Hb concentration for each individual was calculated using the same method, from all their available measurements taken during the evaluation period (Week 17 to Week 21). The change in Hb concentration between the baseline and evaluation periods was calculated by subtracting the baseline Hb concentration from the evaluation period Hb concentration.|Baseline (Day -20 to Day 1), Evaluation Period (Week 17 to Week 21)|ITT population. Hb values within 21 days after blood transfusion(s) were excluded from analysis.||g/dL||Standard Deviation|Mean
770250|NCT00717405|Secondary|Overall Survival (OS) Duration|OS was defined as the time from the first administration of neoadjuvant treatment to death of any cause. OS was estimated using Kaplan-Meier method.|Up to 5 years|ITT population.||months||95% Confidence Interval|Median
770251|NCT00717405|Secondary|Percentage of Participants Who Were Alive at 3 and 5 Years||3, 5 years|ITT population.||percentage of participants||95% Confidence Interval|Number
770252|NCT00717405|Secondary|Recurrence Free Survival (RFS) Duration|RFS was estimated using Kaplan-Meier method.|Up to 5 Years|ITT population.||months||95% Confidence Interval|Median
770253|NCT00717405|Secondary|Percentage of Participants Who Were Recurrence Free at 3 and 5 Years|A participant was considered recurrence free if the participant did not experience local or regional recurrence (wall or axillaries nodes), or occurrence of distant metastases (including soft tissue and distal lymph nodes).|3, 5 years|ITT population.||percentage of participants||95% Confidence Interval|Number
770254|NCT00717405|Secondary|Disease Free Survival (DFS) Duration|DFS was estimated using Kaplan-Meier method.|Up to 5 Years|ITT population.||months||95% Confidence Interval|Median
770255|NCT00717405|Secondary|Percentage of Participants Who Were Disease Free at 3 and 5 Years|A participant was considered disease free if the participant did not experience any of the following events: local recurrence in the ipsilateral breast following lumpectomy, regional recurrence, distant recurrence, contralateral breast cancer, second primary cancer (other than squamous or basal cell carcinoma of the skin, melanoma in situ, carcinoma in situ of the cervix, colon carcinoma in situ, or lobular carcinoma in situ of the breast), or death from any cause.|3, 5 years|ITT population.||percentage of participants||95% Confidence Interval|Number
770256|NCT00717405|Secondary|Breast Cancer Marker CA15.3 at Baseline, Neoadjuvant Final Visit and Change From Baseline at Neoadjuvant Final Visit||Baseline, Neoadjuvant Final Visit (Week 25)|Safety population: Number of participants included all the participants who received at least one infusion of bevacizumab. n included participants who were evaluable at that time point.||Units per milliliter (U/mL)||Standard Deviation|Mean
770257|NCT00717405|Secondary|Percentage of Participants Who Underwent Lymph Node Resection|Among the participants who were planned to undergo mastectomy, lymph node resection was also performed by the physician depending up on the participant's breast cancer grades.|Anytime between Week 26 and Week 29|ITT population. Included participants who underwent mastectomy.||percentage of participants|||Number
770258|NCT00717405|Secondary|Percentage of Participants With Macroscopically Visible Tumor|Local pathologists assessed the tumor whether it was macroscopically visible or not and percentage of participants for whom the tumor was macroscopically visible was reported.|Anytime between Week 26 and Week 29|ITT population. Included participants who underwent mastectomy.||percentage of participants|||Number
770259|NCT00717405|Secondary|Number of Participants Who Underwent Mastectomy|Surgery included a mastectomy with axillary node dissection and had to be performed at least 4 weeks after the last infusion of neoadjuvant bevacizumab treatment.|Anytime between Week 26 and Week 29|ITT population.||participants|||Number
770284|NCT00717977|Primary|Glucose Variability Measure- Standard Deviation by Age Group|Here, 'Standard Deviation' is a measure of glucose variability. This measure was calculated by taking the SD of all glucose values for each subject. Each subject has a SD value. The median and quartiles of this measure over all subjects were reported.|48-72 hours|||mg/dL||Inter-Quartile Range|Median
778131|NCT00774163|Secondary|Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Headache Reported||Day 0 through 6 weeks after Day 0|||days with symptom reported|days of observation||Number
770260|NCT00717405|Secondary|Percentage of Participants Who Were Responders Based on Overall Clinical Response From Baseline at Cycle 5 and Final Treatment Visit|Breast tumor was physically evaluated during the study which included assessment for inflammatory signs and for overall clinical response. Participant with response from baseline based on overall clinical response at Cycle 5 and final treatment visit were presented.|Baseline, Cycle 5 (Week 15), Neo-adjuvant treatment final visit (Week 25)|ITT population. Number of participants analyzed included participants for whom tumor physical examination was performed. n included number of participants who were evaluable at a particular time point.||percentage of participants|||Number
770261|NCT00717405|Secondary|Percentage of Participants Who Were Responders Based on Inflammatory Signs From Baseline at Cycle 5 and Final Treatment Visit|Breast tumor was physically evaluated during the study which included assessment for inflammatory signs and for overall clinical response. Participant with response from baseline based on inflammatory signs at Cycle 5 and final treatment visit were presented.|Baseline, Cycle 5 (Week 15), Neo-adjuvant treatment final visit (Week 25)|ITT population. Number of participants analyzed included participants for whom tumor physical examination was performed and were evaluated for response from baseline assessment of inflammatory signs. n included number of participants who were evaluable at a particular time point.||percentage of participants|||Number
770262|NCT00717405|Secondary|Percentage of Participants With a PCR According to the Chevallier Classification|PCR was assessed at the time of definitive surgery according to Chevallier classification and centrally reviewed by an independent committee under blinded conditions. The Chevallier classification for grading of therapeutic effect related to the primary tumor site and axillary lymph nodes was defined by microscopic changes as follows - Grade 1: Disappearance of all tumors either in the breast or in the nodes, Grade 2: Persistence of carcinoma in situ in the breast only and no nodal invasion, Grade 3: Presence of invasive carcinoma with stromal alteration, Grade 4: Presence of invasive carcinoma without modification. Grade 1 response was considered as PCR. Participants with missing values were considered as non-responders.|From baseline through Week 25 (Up to 6 months)|ITT population.||percentage of participants||95% Confidence Interval|Number
770263|NCT00717405|Primary|Percentage of Participants With a Pathological Complete Response (PCR) According to the Sataloff Classification|PCR was assessed at the time of definitive surgery according to Sataloff classification and centrally reviewed by an independent committee under blinded conditions. Pathological response was defined based on the therapeutic response at the primary tumor site and axillary lymph nodes. Primary tumor response criteria were as follows: T-A (Total / near total therapeutic effect), T-B (Subjectively greater than [>] 50 percent [%] therapeutic effect but less than [<] T-A), T-C (<50% therapeutic effect, but effect evident), T-D (No therapeutic effect). Axillary lymph node response: N-A (Evidence of therapeutic effect, no metastases), N-B (No therapeutic effect, no nodal metastases), N-C (Nodal metastasis but evident therapeutic effect), N-D (Nodal metastasis with no therapeutic effect). T-A and N-A or T-A and N-B responses were defined as PCR and all other tumor responses as non-responders. Participants with missing values were considered as non-responders.|From baseline through Week 25 (Up to 6 months)|ITT population.||percentage of participants||95% Confidence Interval|Number
770264|NCT00717418|Other Pre-specified|Schirmer's Test With and Without Anesthesia at Baseline|Schirmer’s Test with and without anesthesia at baseline. The Schirmer’s test is performed on each eye with and without anesthesia (numbing eye drop). The amount of wetting produced by the eye was measured in millimeters using a graduated paper scale. The results indicate the presence of dry eye (Normal = greater than or equal to 15 millimeters (mm), Dry eye = less than 15 mm). A larger number correlates to better tear production, a smaller number correlates to reduced tear production.|Baseline|Intent-to-treat, which included all patients who started the study (completed baseline visit).||millimeters (mm)||Standard Deviation|Mean
770265|NCT00717418|Primary|Ocular Surface Disease Index (OSDI) Total Score at Baseline|The OSDI consists of 12 questions to assess visual function, ocular symptoms and environmental triggers related to dry eye. Each of the 12 questions is assessed using a 5-point scale (0=none of the time; 4 = all of the time) which is converted to a total score between 0-100. OSDI total scores of 0-12=normal (best), 13-22= mild ocular surface disease, 23-32 =moderate ocular surface disease, and 33-100=severe ocular surface disease (worst).|Baseline|Intent-to-treat, which included all patients who started the study (completed baseline visit) and were assessed for this outcome measure. 16 subjects did not complete this outcome measure assessment and were not included in the analysis.||Scores on a Scale||Standard Deviation|Mean
770266|NCT00717522|Secondary|Tumor Response as Assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee Guidelines|Changes in only the longest diameter (LD) of tumor lesions are used in RECIST criteria. Evaluation of target lesions: Complete Response (CR)=Disappearance of all target lesions; Partial Response (PR)=≥30% decrease in sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD; Progressed Disease (PD)=≥20% increase in sum of LD of target lesions taking as reference the smallest sum LD recorded since treatment started or the appearance of ≥1 new lesions; Stable Disease (SD)=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum LD since treatment started. For non-target lesions: CR= Disappearance of all non-target lesions and normalization of tumor marker level; Incomplete Response/SD=Persistence of ≥1 non-target lesions and/or maintenance of tumor marker level above normal limits; PD=Appearance of ≥1 new lesions; unequivocal progression of existing non-target lesions.|Assessed every 8 weeks for the first 8 months and then every 12 weeks thereafter, and at treatment discontinuation. Median treatment duration was 49 days (range: 3 to 102 days).|This analysis was not done. Study enrollment was suspended due to a corporate strategic decision unrelated to patient safety, and the protocol was amended to evaluate safety only (efficacy data was stored but not cleaned or analyzed unless related to safety).|||||
770285|NCT00717977|Primary|Percentage of Sensor Glucose Levels >140 mg/dl by Time of Day|"The Percentage of Sensor Glucose Levels >140 mg/dl was calculated for each subject separately for the daytime and nighttime period. The median and quartiles over all subjects were reported.
Here the data is different with data analyzed by age group, which is a subgroup analysis on 'percentage of sensor glucose levels >140 mg/dl' for all 24 hours."|48-72 hours|||Percent||Inter-Quartile Range|Median
770286|NCT00717977|Primary|Percentage of Sensor Glucose Levels >140 mg/dL by Age Group||48-72 hours|||Percent||Inter-Quartile Range|Median
770287|NCT00717977|Primary|Percentage of Sensor Glucose Levels >120 mg/dl by Time of Day||48-72 hours|||Percent||Inter-Quartile Range|Median
770288|NCT00717977|Primary|Percentage of Sensor Glucose Levels >120 mg/dL by Age Group||48-72 hours|||Percent||Inter-Quartile Range|Median
770267|NCT00717522|Primary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, or Discontinuations Due to AEs|An adverse event (AE) is defined as any noxious, unintended, or untoward medical occurrence occurring at any dose that may appear or worsen in a study subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the study subject’s health, including laboratory test values, regardless of etiology. A serious adverse event (SAE) is defined as any AE which: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE), Version 3.0, grades: 1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, 5 = death. For more details, please see the Adverse Events section of this record.|AEs/SAEs were recorded from informed consent to 30 days post treatment discontinuation visit. Median treatment duration was 49 days (range: 3 to 102 days).|All participants||participants|||Number
770268|NCT00717574|Primary|The Effect of Nitrous Oxide on Bispectral Index (BIS) and State Entropy Index (SE)|"We planned this study to compare the effect of adding N2O on BIS and SE during an intravenous or an inhalation anesthetic. We hypothesized that neither BIS nor SE would decrease in response to the addition of N2O to a Propofol anesthetic. We also hypothesized that neither BIS nor SE would decrease in participants under Sevoflurane anesthesia if the inspired concentration of Sevoflurane were carefully and continuously adjusted to maintain a constant end-tidal concentration during the addition and discontinuation of N2O.
BIS (0-100) and SE (0-92) are unitless, ordinal indices of anesthetic depth. Both indices are decreased when the depth of anesthesia is increased."|From baseline to 20 minutes after the addition of 60% nitrous oxide|||units on a scale||Standard Deviation|Mean
770269|NCT00717756|Primary|Response Rate by Recist Criteria|"radiographic response defined as partial response defined by RECIST:At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD
It is noted that while on average the time frame for scans was 4 months, there were two patients who at 32 and 36 months had not progressed."|on average about every 2 months until progression, on average about 4 months.|||participants|||Number
770270|NCT00717860|Secondary|Number of Participants With Favorable Overall Response at the End of Study Therapy|Favorable overall response for each infection category of deep-seated fungal infections was based on the determination of the Independent Efficacy Assessment Committee.|1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis|Per Protocol Set (PPS) population.||Participants|||Number
770271|NCT00717860|Secondary|Number of Participants With a Specific Safety Finding|A specific safety finding was defined as a drug-related adverse experience, a serious drug-related adverse experience, or a drug-related adverse experience leading to study therapy discontinuation.|1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis|APaT population.||Participants|||Number
770272|NCT00717860|Primary|Number of Participants With a Significant Drug-related Adverse Experience|A significant drug-related adverse experience was defined as a serious drug-related adverse experience or a drug-related adverse experience leading to study therapy discontinuation.|1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis|All Participants as Treated (APaT) population.||Participants|||Number
770273|NCT00717873|Primary|Hospital Length of Stay|an average of 10 days|Admission to Discharge|||days||Standard Deviation|Mean
770274|NCT00717886|Primary|Number and Prevalence of Metastases of Blue Nodes in the ALND Specimen (Nodes Draining the Breast).||2 years|||participants|||Number
770275|NCT00717912|Secondary|Insulinemic Index|"The specific measure that will be use to determine the insulinemic responses is the change in blood insuline levels compared with the levels achieved after they have eaten a control food containing the same amount of digestible carbohydrate.
Sugar syrup was used as the reference food, giving it a insulinemic index value of 100 by definition. The AUC of the test food is divided by the AUC of the standard (glucose) and multiplied by 100. Low GI: 55 or less, Medium GI: 56-69, High GI: 70 and above"|Every 48 hours (each new intervention), over a 2 hour blood glucose challenge|||% of the GI of the glucose||Standard Deviation|Mean
770276|NCT00717912|Primary|Glycemic Index|"The specific measure that will be use to determine the glycemic responses is the change in blood sugar levels compared with the levels achieved after they have eaten a control food containing the same amount of digestible carbohydrate.
Sugar syrup was used as the reference food, giving it a glycemic index value of 100 by definition. The AUC of the test food is divided by the AUC of the standard (glucose) and multiplied by 100. Low GI: 55 or less, Medium GI: 56-69, High GI: 70 and above"|Every 48 hours (each new intervention), over a 2 hour blood glucose challenge|||% of GI of the glucose||Standard Deviation|Mean
770277|NCT00717977|Primary|Glucose Variability Measure: Amplitude of Glycemic Excursions by Time of Day|The Mean Amplitude of Glycemic Excursions also known as MAGE depicts the upward and downward acute glucose fluctuations seen in the sensor data.|48-72 hours|||mg/dL||Inter-Quartile Range|Median
770278|NCT00717977|Primary|Glucose Variability Measure: Mean Amplitude of Glycemic Excursions by Age Group|The Mean Amplitude of Glycemic Excursions also known as MAGE depicts the upward and downward acute glucose fluctuations seen in the sensor data.|48-72 hours|||mg/dL||Inter-Quartile Range|Median
770279|NCT00717977|Primary|Glucose Variability Measure- Coefficient of Variation by Time of Day|The Coefficient of Variation is calculated by dividing the standard deviation by the mean glucose. Each subject received a SD value. The median and quartiles of this measure over all subjects were reported.|48-72 hours|||Percent||Inter-Quartile Range|Median
770280|NCT00717977|Primary|Glucose Variability Measure- Coefficient of Variation by Age Group|The Coefficient of Variation is calculated by dividing the standard deviation by the mean glucose. Each subject received a SD value. The median and quartiles of this measure over all subjects were reported.|48-72 hours|||Percent||Inter-Quartile Range|Median
770281|NCT00717977|Primary|Glucose Variability Measure- Absolute Rate of Change by Time of Day||48-72 hours|||mg/dL/min||Inter-Quartile Range|Median
770282|NCT00717977|Primary|Glucose Variability Measure- Absolute Rate of Change by Age Group||48-72 hours|||mg/dL/min||Inter-Quartile Range|Median
770283|NCT00717977|Primary|Glucose Variability Measure- Standard Deviation by Time of Day|Here, 'Standard Deviation' is a measure of glucose variability. This measure was calculated by taking the SD of all glucose values for each subject. Each subject has a SD value. The median and quartiles of this measure over all subjects were reported.|48-72 hours|||mg/dL||Inter-Quartile Range|Median
770289|NCT00717977|Primary|Percentage of Sensor Glucose Levels <=60 mg/dl by Time of Day|"The Percentage of Sensor Glucose Levels <=60 mg/dl was calculated for each subject separately for the daytime and nighttime period. The median and quartiles over all subjects were reported.
Here the data is different with data analyzed by age group, which is a subgroup analysis on 'percentage of sensor glucose levels <=60mg/dL' for all 24 hours."|48-72 hours|||Percent||Inter-Quartile Range|Median
770290|NCT00717977|Primary|Percentage of Sensor Glucose Levels <=60 mg/dL by Age Group||48-72 hours|||Percent||Inter-Quartile Range|Median
770291|NCT00717977|Primary|Percentage of Sensor Glucose Levels <=70 mg/dl by Time of Day||48-72 hours|||Percent||Inter-Quartile Range|Median
770292|NCT00717977|Primary|Distribution of Sensor Glucose Levels <=70 mg/dL by Age Group||48-72 hours|||Percent||Inter-Quartile Range|Median
770293|NCT00717977|Primary|Percentage of Sensor Glucose Levels 71-120 mg/dL by Time of Day||48-72 hours|||Percent||Inter-Quartile Range|Median
770294|NCT00717977|Primary|Percentage of Sensor Glucose Levels Between 71-120 mg/dL by Age Group|The Percentage Sensor Glucose Levels between 71-120 mg/dL was calculated for each subject. The median and quartiles over all subjects were reported here.|48-72 hours|||Percent||Inter-Quartile Range|Median
770295|NCT00717977|Primary|Nighttime Nadir Sensor Glucose Value by Age Group|The calculation of peak and nadir glucose was restricted to days with >=12 hours and nights with >=4 hours of sensor glucose data. The nighttime nadir reflects the lowest point on the sensor glucose curve registered among nighttime values.|48-72 hours|||mg/dL||Inter-Quartile Range|Median
770296|NCT00717977|Primary|Daytime Nadir Sensor Glucose Value by Age Group|The calculation of peak and nadir glucose was restricted to days with >=12 hours and nights with >=4 hours of sensor glucose data. The daytime nadir reflects the lowest point on the sensor glucose curve registered among daytime values.|48-72 hours|||mg/dL||Inter-Quartile Range|Median
770297|NCT00717977|Primary|Peak Nightime Sensor Glucose Value by Age Group|The calculation of peak and nadir glucose was restricted to days with >=12 hours and nights with >=4 hours of sensor glucose data.|48-72 hours|||mg/dL||Inter-Quartile Range|Median
770298|NCT00717977|Primary|Peak Daytime Sensor Glucose Value by Age Group|The calculation of peak and nadir glucose was restricted to days with >=12 hours and nights with >=4 hours of sensor glucose data.|48-72 hours|||mg/dL||Inter-Quartile Range|Median
770299|NCT00717977|Primary|Nighttime (Midnight - 6:00 a.m.) Mean Sensor Glucose by Age Group|Mean glucose value was calculated for every hour of the 24 hours of the day. This measure is the average from midnight to 6 a.m.|48-72 hours|||mg/dL||Standard Deviation|Mean
770300|NCT00717977|Primary|Daytime (6:00 a.m. - Midnight) Mean Sensor Glucose by Age Group|Mean glucose value was calculated for every hour of the 24 hours of the day. This measure is the average from 6 a.m. to midnight.|48-72 hours|||mg/dL||Standard Deviation|Mean
770301|NCT00717977|Primary|Overall Mean Sensor Glucose by Age Group|Mean glucose value was calculated for every hour of the 24 hours of the day. This measure is the average over all 24 hours.|48-72 hours|||mg/dL||Standard Deviation|Mean
770302|NCT00718042|Secondary|ESA Chagas Testing in Chagas Endemic Population|Specimen collected in Chagas endemic areas in South or Central America (524) tested with ESA Chagas and licensed test for T cruzi antibody. Specimens repeatedly reactive with either screening assay and/or ESA Chagas positive were tested with supplemental assay (RIPA). Presentation of ESA Chagas results for 132 specimens from a Chagas endemic population that were RIPA positive.|2 months|Total of 132 out of the 524 specimens from Chagas endemic areas that were tested RIPA positive per protocol.||participants|||Number
770303|NCT00718042|Secondary|ESA Chagas Sensitivity in Serologically Positive Non-US Specimens|ESA Chagas Sensitivity in a non-US population was determined for the 85 out of the total 287 serologically positive specimens (202 US Serology Positive specimens were excluded). These specimens were collected from individuals positive for T cruzi antibodies based on 2 different serologic tests for antibodies to T cruzi in Argentina and were tested with ESA Chagas.|3 months|A total of 85 serum specimens from non-US individuals reactive for T cruzi antibodies per protocol.||participants|||Number
770304|NCT00718042|Primary|ESA Chagas Sensitivity|Specimens from individuals known to be T cruzi parasite positive were tested with ESA Chagas assay.|3 months|Specimens from 110 subjects known to be positive for T cruzi parasite tested with ESA Chagas per protocol.||participants|||Number
770305|NCT00718042|Primary|ESA Chagas Specificity|Preselected US blood donor specimens (330) presumed T cruzi antibody negative negative that were tested only with the investigational ESA Chagas.|3 months|Determine percentage of donor specimens ESA Chagas negative in a presumed negative population per protocol.||participants|||Number
770306|NCT00718042|Secondary|ESA Chagas Testing of US Blood Donor Specimens Repeatedly Reactive by ABBOTT PRISM Chagas.|A total of 41,760 US blood donor specimens were tested by ABBOTT PRISM Chagas. Of these specimens, 58 out of 79 specimens were T cruzi antibody repeatedly reactive by ABBOTT PRISM Chagas (26 from 16,249 donor specimens tested in design validation phase and 32 from 25,511 specimens from the Chagas extended evaluation). Donor specimens that were repeatedly reactive with the licensed T cruzi antibody assay, but PRISM Chagas nonreactive (6) and specimens PRISM Chagas grayzone negative (15) were excluded from this analysis.|15 months|A total of 58 US blood donor specimens were PRISM Chagas repeatedly reactive were included per protocol.||participants|||Number
770307|NCT00718042|Secondary|PRISM Chagas Reactivity in Chagas Endemic Population|Population of specimen collected in Chagas endemic area in South/Central America (524) were tested to demonstrate reactivity with the PRISM Chagas assay in a population with a 5% or greater prevalence of infection with T cruzi antibody. specimens tested with PRISM Chagas assay and licensed test for T cruzi antibody and if repeatedly reactive with either assay the specimens were tested with supplemental assay (RIPA). Data presented with PRISM Chagas and RIPA results.|2 months|Total of 524 specimens from Chagas endemic areas tested with PRISM Chagas per protocol.||participants|||Number
770308|NCT00718042|Primary|PRISM Chagas Sensitivity|Specimens from subjects known to be T cruzi parasite positive were tested with PRISM Chagas assay.|6 months|Specimens from 110 individuals known to be positive for T cruzi parasite were tested with PRISM Chagas assay per protocol.||participants|||Number
770309|NCT00718042|Secondary|PRISM Chagas Reactivity Serology Positive Specimens|Total of 85 specimens from subjects from South America known to be positive for T cruzi antibodies and 202 US blood donor specimens that were repeatedly reactive on a licensed test for antibodies to T cruzi were tested with the PRISM Chagas assay and supplemental testing (RIPA).|4 months|Total of 287 specimens presumed T cruzi antibody positive per protocol.||participants|||Number
770310|NCT00718042|Primary|PRISM Chagas Specificity|Total of 16,249 serum and plasma blood donor specimens tested with PRISM Chagas assay during design validation phase. Repeatedly reactive specimens were tested further with a supplemental assay [radioimmune precipitation assay (RIPA)].|6 months|All fresh blood donor specimens tested with PRISM Chagas assay during design validation phase per protocol.||participants|||Number
770311|NCT00718081|Secondary|Proportion of Patients Who Responded Very Good or Excellent in Patient Global Evaluation of Pain Relief|At the end of the 12-hour study period each patient rated their overall pain relief since starting study drug on a 5-point scale: poor, fair, good, very good or excellent.|Up to 12 hours after surgery|||percentage of patients|||Number
770312|NCT00718081|Primary|SPID-12|The primary outcome measure is the summed pain intensity difference over the 12-hour study period (SPID-12). A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and throughout the 12 hour study period. The SPID-12 is calculated by summing the difference between baseline pain score and pain score at each assessment time point. The scores after summing could range from -122 to +122. A higher SPID-12 score is better.|12 hours after surgery|||units on a scale||Standard Error|Least Squares Mean
770313|NCT00718120|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|During the 21-day (Day 0-20) post-vaccination period|||subjects|||Number
770314|NCT00718120|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|During the 21-day (Day 0-20) post-vaccination period|||subjects|||Number
770315|NCT00718120|Secondary|Number of Subjects Reporting Solicited Symptoms|Solicited local symptoms assessed include pain, redness, and swelling. Solicited general symptoms assessed include bronchospasm, chills, cough, fatigue, headache, joint pain at other location, muscle aches, red eyes, sore throat, swelling of the face, and fever.|During the 4-day (Day 0-3) post-vaccination period|||subjects|||Number
770316|NCT00718120|Primary|Fold Increase From Baseline in Serum HI Antibody Titer|The fold increase in serum HI antibody titer post-vaccination (Day 21) compared to pre-vaccination (Day 0) was calculated by dividing the geometric mean antibody titers of Day 21 by those of Day 0. Data are presented for all three vaccine influenza virus strains.|At Day 21|||fold increase|||Number
770317|NCT00718120|Primary|Number of Seroprotected Subjects|Seroprotection, defined as a serum HI antibody titer ≥ 1:40, is presented for all three vaccine influenza virus strains.|At Day 0 and 21|||subjects|||Number
770318|NCT00718120|Primary|Number of Seroconverted Subjects|Seroconversion, defined as a pre-vaccination serum HI titer < 1:10 and a post-vaccination serum HI titer ≥ 1:40, or a pre-vaccination serum HI titer ≥ 1:10 and at least a 4-fold increase in post-vaccination serum HI titer, is presented for all three vaccine influenza virus strains.|At Day 21|||subjects|||Number
770319|NCT00718120|Primary|Hemagglutination Inhibition (HI) Antibody Titers|Titers, given as geometric mean titers (GMTs), are presented for all three vaccine influenza virus strains.|At Day 0 and 21|||titer||95% Confidence Interval|Geometric Mean
770320|NCT00710866|Primary|Adverse Events: Fever After Either Dose - Toddlers(12-23 Months)-|Fever defined as temperature >= 38 C|3 days after immunization|Per Protocol||participants|||Number
770321|NCT00710866|Primary|Adverse Events: Fever After Either Dose - Infants 6-11 Months|Fever defined as temperature >= 38 C|3 days after immunization|Per Protocol||participants|||Number
770322|NCT00710866|Primary|Seroprotection Rate Toddlers (12-23 Months)-B/Florida/4/06(Yamagata)|Seroprotection rate: HI titers =>40|27-46 days after the second dose|Per Protocol||participants|||Number
770323|NCT00710866|Primary|Seroprotection Rate Infants (6-11 Months)-B/Florida/4/06(Yamagata)||27-46 days after the second dose|Per Protocol||participants|||Number
770324|NCT00710866|Primary|Seroprotection Rate Toddlers(12-23 Months)-A/Brisbane/10/07(H3N2)|Seroprotection rate: HI titers =>40|27-46 days after the second dose|Per Protocol||participants|||Number
770325|NCT00710866|Primary|Seroprotection Rate Infants(6-11 Months)-A/Brisbane/10/07(H3N2)|Seroprotection rate: HI titers =>40|27-46 days after the second dose|Per Protocol||participants|||Number
770326|NCT00710866|Primary|Seroprotection Rate Toddlers(12-23 Months)-A/Brisbane/59/07(H1N1)|Seroprotection rate: HI titers =>40|27-46 days after the second dose|Per Protocol||participants|||Number
770327|NCT00710866|Primary|Seroprotection Rate Infants (6-11 Months)-A/Brisbane/59/07(H1N1)|Seroprotection rate: HI titers =>40|27-46 days after the second dose|Per Protocol||participants|||Number
770328|NCT00710879|Secondary|Solution Utlility|The Utility was determined based on the results of the efficacy and safety evaluations.|3 months, 6 months|All Eligible, Dispensed Eyes||Eyes|Participants||Number
770329|NCT00710879|Secondary|Solution Related AE's and Lens Changes|Very Safe = No solution related AEs and no changes in lens properties related to the solution. Safe = No solution related AEs and slight change in lens properties related to the solution, but lens wear was continued. Skeptical = Solution related AEs were suspected and lens properties changed due to the solution and lens wear was discontinued. Not Safe = Solution related AEs were present and lens properties changed due to the solution and lens wear was discontinued.|3 months, 6 months|All Eligible, Dispensed Eyes||Eyes|Participants||Number
770330|NCT00710879|Primary|Antimicrobial Efficacy|Excellent = No bacterial infection suspected and no ocular pathogens detected and bacteria of normal flora <0-103 CFU/mL. Good = No bacterial infection suspected and no ocular pathogens detected and bacteria of normal flora <103-105 CFU/mL. Skeptical = Bacterial infection suspected and ocular pathogens detected and bacteria of normal flora ≥ 105 CFU/mL. No Efficacy = Bacterial infection definite and ocular pathogens detected and bacteria of normal flora ≥ 105 CFU/mL. Pathogens were H. aegyptius, H. influenzae, Moraxella spp., P. aeruginosa, S. pneumoniae, S. aureus, N. gonorrhoeae|2 weeks, 3 months|All eligible, dispensed eyes with cultures taken within window. Group I subjects were cultured at the 3-Month Visit. Group IV subjects were cultured at the 2-week Follow-up visit.||Eyes|Participants||Number
770365|NCT00711009|Secondary|Mean Change From Baseline in Soluble Tumor Necrosis Factor Receptor-2 (Picograms/Milliliter)|Included in measures of metabolic toxicity|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||picograms/milliliter||Standard Deviation|Mean
770331|NCT00710905|Primary|Binocular Visual Acuity at Near, Intermediate and Distance|Binocular uncorrected and best corrected visual acuity (VA) was tested at 4 meters (m) (distance), 60 centimeters (cm) (intermediate), and near at preferred distance (distance chosen by each subject and recorded in cm; mean and standard deviation calculated) with a standard ETDRS chart for distance and a hand held chart for near. Scores were calculated using logMAR values. LogMAR is the “logarithm of the minimum angle of resolution”. A lower logMAR value indicates better VA.|6 months after surgery|||LogMAR||Standard Deviation|Mean
770332|NCT00710931|Primary|Binocular Visual Acuity at Distance, Near and Intermediate|Uncorrected and best corrected visual acuity (VA) was tested at 4 meters (m), 60 centimeters (cm), and near at preferred distance (distance chosen by each subject and recorded in cm; mean and standard deviation calculated) with a standard ETDRS chart for distance and a hand held chart for near. VA is measured in logMAR. LogMAR is the “logarithm of the minimum angle of resolution”. A lower logMAR value indicates better VA.|6 months after surgery|||LogMAR||Standard Deviation|Mean
770333|NCT00710944|Primary|Implant Survival|An implant that has failed to osseointegrate, lost its osseointegration or fractured was considered a failure effective from the date of removal. The survival rate for individual implants was analyzed at each visit. Cumulative implant survival rate was calculated using Kaplan-Meier life-table estimation and reported as percentage of survived implants.|12 months after implant placement|Per protocol analysis presented, this includes implants immediately loaded (Group A: 55 implants in 55 subjects, Group B: 58 implants in 58 subjects, Group C: 19 implants in 19 subjects), of these 5 implants in total failed within 12 months after implant placement.||percentage of implants|Participants||Number
770334|NCT00710970|Primary|Sustained Stable Disease is Considered to be Clinically Important. Hence, 4-month Freedom From Progression (FFP) (Stable Disease + Partial Response + Complete Response) is Chosen as the Primary End-point Instead of Response Rate.||4 months|||participants|||Number
770335|NCT00710970|Primary|Tamoxifen : Tamoxifen is Administered at 20 mg/Day as a Single Daily Oral Dose. Tamoxifen is Continued Until Progressive Disease or Intolerable Grade 3 or 4 Side Effects Occur Due to Tamoxifen.||To progression||||||
770336|NCT00710996|Primary|Photostress Recovery Time in Seconds.|The time necessary to recover function (e.g., contrast discrimination) following exposure to a bright glare source.|3 months|||seconds||Standard Deviation|Mean
770337|NCT00711009|Secondary|Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Bone Mineral Density (Grams/cm^2)|The dual energy X-ray absorptiometry (DEXA) scan of bone mineral content was used to evaluate potential bone effects of treatment.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.||grams/cm^2||Standard Deviation|Mean
770338|NCT00711009|Secondary|Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Bone Mineral Content (Grams)|The dual energy X-ray absorptiometry (DEXA) scan of bone mineral content was used to evaluate potential bone effects of treatment.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.||grams||Standard Deviation|Mean
770339|NCT00711009|Secondary|Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Mass (Grams)|The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.||grams||Standard Deviation|Mean
770340|NCT00711009|Secondary|Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Lean Mass (Grams)|The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.||grams||Standard Deviation|Mean
770341|NCT00711009|Secondary|Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Fat (Grams)|The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.||grams||Standard Deviation|Mean
770342|NCT00711009|Secondary|Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Mass (Grams)|The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.||grams||Standard Deviation|Mean
770343|NCT00711009|Secondary|Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Lean Mass (Grams)|The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.||grams||Standard Deviation|Mean
770344|NCT00711009|Secondary|Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Fat (Grams)|The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.||grams||Standard Deviation|Mean
770345|NCT00711009|Secondary|Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Lower Extremity Total Mass (Grams)|The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.||grams||Standard Deviation|Mean
770346|NCT00711009|Secondary|Mean Change From Baseline in DEXA Scan of Lower Extremity Lean Mass (Grams)|The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.||grams||Standard Deviation|Mean
770347|NCT00711009|Secondary|Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Lower Extremity Fat (Grams)|The dual energy X-ray absorptiometry (DEXA) is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.||grams||Standard Deviation|Mean
770348|NCT00711009|Secondary|Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Total Mass (Grams)|The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.||grams||Standard Deviation|Mean
770349|NCT00711009|Secondary|Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Lean Mass (Grams)|The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.||grams||Standard Deviation|Mean
770350|NCT00711009|Secondary|Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Fat (Grams)|The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.||grams||Standard Deviation|Mean
770351|NCT00711009|Secondary|Mean Change From Baseline in Mid-Thigh Measurement (cm)|Mid-thigh circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Particpant’s thigh circumference was measured halfway between the inguinal crease and the midpoint of the upper border of the patella using non-stretchable measuring tape with half centimeter marks.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.||cm||Standard Deviation|Mean
770352|NCT00711009|Secondary|Mean Change From Baseline in Hips Measurement (cm)|Hip circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Participant was measured at widest width of the hip using non-stretchable measuring tape with half centimeter marks.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.||cm||Standard Deviation|Mean
770353|NCT00711009|Secondary|Mean Change From Baseline in Mid-Arm Measurement (cm)|Arm circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Particpant’s arm circumference was measured halfway between the acromial process on the shoulder and the tip of the elbow (olecranon process) using non-stretchable measuring tape with half centimeter marks.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.||cm||Standard Deviation|Mean
770354|NCT00711009|Secondary|Mean Change From Baseline in Waist Measurement (cm)|Waist circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Circumference of participant’s waist was measured at the level of the navel using non-stretchable measuring tape with half centimeter marks.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.||cm||Standard Deviation|Mean
770355|NCT00711009|Secondary|Mean Change From Baseline in Chest Measurement (cm)|Chest circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Participant’s chest circumference was measured at 5 cm above the xiphoid process using non-stretchable measuring tape with half centimeter marks.|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||cm||Standard Deviation|Mean
770356|NCT00711009|Secondary|Mean Change From Baseline in Temperature (°F)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||°F||Standard Deviation|Mean
770357|NCT00711009|Secondary|Mean Change From Baseline in Weight (kg)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||kg||Standard Deviation|Mean
770358|NCT00711009|Secondary|Mean Change From Baseline in Sitting Heart Rate (Beats Per Minute)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||beats per minute||Standard Deviation|Mean
770359|NCT00711009|Secondary|Mean Change From Baseline in Sitting Diastolic Blood Pressure (mm Hg)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||mm Hg||Standard Deviation|Mean
770360|NCT00711009|Secondary|Mean Change From Baseline in Sitting Systolic Blood Pressure (mm Hg)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||mm Hg||Standard Deviation|Mean
770361|NCT00711009|Secondary|Mean Change From Baseline in Urine pH||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||pH||Standard Deviation|Mean
770362|NCT00711009|Secondary|Mean Change From Baseline in Urine Specific Gravity|Urine specific gravity is a laboratory test that measures the concentration of all chemical particles in the urine. The measurement produces a ratio of the urine density to water density.|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||ratio of urine density to water density||Standard Deviation|Mean
770363|NCT00711009|Secondary|Mean Change From Baseline in Insulin (Picomoles/Liter)|Included in measures of metabolic toxicity|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||picomoles/liter||Standard Deviation|Mean
770364|NCT00711009|Secondary|Mean Change From Baseline in Leptin (Nanograms/Milliliter)|Included in measures of metabolic toxicity|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||nanograms/milliliter||Standard Deviation|Mean
778132|NCT00774163|Secondary|Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Pruritis Reported||Day 0 through 6 weeks after Day 0|||days with symptom reported|days of observation||Number
770376|NCT00711009|Secondary|Mean Change From Baseline in Low Density Lipoprotein (LDL): High Density Lipoprotein (HDL) Ratio (Ratio)||Baseline to Week 96|Participants who had values for both measures (LDL and HDL) at Baseline and Week 96 are included in the analysis.||ratio||Standard Deviation|Mean
770377|NCT00711009|Secondary|Mean Change From Baseline in Low Density Lipoprotein (LDL) (Micromoles/Liter)|Included in measures of metabolic toxicity|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||micromoles/liter||Standard Deviation|Mean
770378|NCT00711009|Secondary|Mean Change From Baseline in High Density Lipoprotein Cholesterol (HDL) (Micromoles/Liter)|Included in measures of metabolic toxicity|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||micromoles/liter||Standard Deviation|Mean
770379|NCT00711009|Secondary|Mean Change From Baseline in Cholesterol (Micromoles/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||micromoles/liter||Standard Deviation|Mean
770380|NCT00711009|Secondary|Mean Change From Baseline in Total Protein (Grams/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||grams/liter||Standard Deviation|Mean
770381|NCT00711009|Secondary|Mean Change From Baseline in Albumin (Grams/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||grams/liter||Standard Deviation|Mean
770382|NCT00711009|Secondary|Mean Change From Baseline in Bicarbonate (Micromoles/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||micromoles/liter||Standard Deviation|Mean
770383|NCT00711009|Secondary|Mean Change From Baseline in Chloride (Micromoles/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||micromoles/liter||Standard Deviation|Mean
770384|NCT00711009|Secondary|Mean Change From Baseline in Potassium (Micromoles/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||micromoles/liter||Standard Deviation|Mean
770385|NCT00711009|Secondary|Mean Change From Baseline in Sodium (Micromoles/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||micromoles/liter||Standard Deviation|Mean
770386|NCT00711009|Secondary|Mean Change From Baseline in Calcium (Micromoles/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||micromoles/liter||Standard Deviation|Mean
770387|NCT00711009|Secondary|Mean Change From Baseline in Inorganic Phosphate (Micromoles/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||micromoles/liter||Standard Deviation|Mean
770388|NCT00711009|Secondary|Mean Change From Baseline in Uric Acid (Micromoles/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||micromoles/liter||Standard Deviation|Mean
770389|NCT00711009|Secondary|Mean Change From Baseline in Blood Urea Nitrogen (Micromoles/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||micromoles/liter||Standard Deviation|Mean
770390|NCT00711009|Secondary|Mean Change From Baseline in Creatinine (Micromoles/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||micromoles/liter||Standard Deviation|Mean
770391|NCT00711009|Secondary|Mean Change From Baseline in Total Bilirubin (Micromoles/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||micromoles/liter||Standard Deviation|Mean
770392|NCT00711009|Secondary|Mean Change From Baseline in Creatine Phosphokinase (Units/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||units/liter||Standard Deviation|Mean
770393|NCT00711009|Secondary|Mean Change From Baseline in Alkaline Phosphatase (Units/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||units/liter||Standard Deviation|Mean
770394|NCT00711009|Secondary|Mean Change From Baseline in Aspartate Aminotransferase (Units/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||units/liter||Standard Deviation|Mean
770395|NCT00711009|Secondary|Mean Change From Baseline in Alanine Aminotransferase (Units/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||units/liter||Standard Deviation|Mean
770396|NCT00711009|Secondary|Mean Change From Baseline in Basophils (x 10^9/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||number of cells x 10^9/liter||Standard Deviation|Mean
770397|NCT00711009|Secondary|Mean Change From Baseline in Eosinophils (x 10^9/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||number of cells x 10^9/liter||Standard Deviation|Mean
770398|NCT00711009|Secondary|Mean Change From Baseline in Monocytes (x 10^9/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||number of cells x 10^9/liter||Standard Deviation|Mean
770399|NCT00711009|Secondary|Mean Change From Baseline in Lymphocytes (x 10^9/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||number of cells x 10^9/liter||Standard Deviation|Mean
770400|NCT00711009|Secondary|Mean Change From Baseline in Neutrophils (x 10^9/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||number of cells x 10^9/liter||Standard Deviation|Mean
770401|NCT00711009|Secondary|Mean Change From Baseline in White Blood Cell Count (x 10^9/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||number of cells x 10^9/liter||Standard Deviation|Mean
770402|NCT00711009|Secondary|Mean Change From Baseline in Platelet Count (x 10^9/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||number of cells x 10^9/liter||Standard Deviation|Mean
770403|NCT00711009|Secondary|Mean Change From Baseline in Red Blood Cell Count (x 10^12/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||number of cells x 10^12/liter||Standard Deviation|Mean
770876|NCT00720434|Secondary|Alanine Aminotransferase (ALT) Levels||Week 4, 12, 48, 72|FAS included all randomized participants who received at least 1 dose of study drug and had both baseline and at least 1 valid post-baseline endpoint measurements for HCV viral load. Here ‘n’ signifies participants evaluable for this measure at specified time points for each arm, respectively.||IU/L||Standard Deviation|Mean
770404|NCT00711009|Secondary|Mean Change From Baseline in Hematocrit (Fraction)|Hematocrit fraction is the percentage (%) by volume of packed red blood cells (RBCs) in the participant's blood. It was measured using standard clinical laboratory analysis of participants' blood samples.|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||% by volume of packed RBCs in blood||Standard Deviation|Mean
770405|NCT00711009|Secondary|Mean Change From Baseline in Hemoglobin (Grams/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||grams/liter||Standard Deviation|Mean
770406|NCT00711009|Secondary|Score on Global Satisfaction Scale of Treatment Satisfaction Questionnaire for Medication|The Global Satisfaction scale of the TSQM evaluates the participants rating of whether the good things about the medication outweigh the bad things (1=not at all certain to 5=extremely certain) and how satisfied or dissatisfied the participant is with the medication (1=extremely dissatisfied to 7=extremely satisfied). Scores are converted to a range of 0 to 100. Higher scores indicate greater satisfaction.|Week 96|Participants who had values at Week 96 were included in the analysis.||Scores on a scale||Standard Deviation|Mean
770407|NCT00711009|Secondary|Score on Side Effects Scale of Treatment Satisfaction Questionnaire for Medication|The Side Effects scale of the TSQM asks if the participant experiences side effects (yes/no), and if so, how bothersome the side effects are, to what extent they interfere with physical health and ability to function (for example, strength and energy levels), to what extent they interfere with mental function (for example, ability to think clearly, stay awake, etc.), and to what extent the side effects affect the participants overall satisfaction with the medication. Scores are converted to a range of 0 to 100. Higher scores indicate less interference and/or less dissatisfaction.|Week 96|Participants who had values at Week 96 were included in the analysis.||Scores on a scale||Standard Deviation|Mean
770408|NCT00711009|Secondary|Score on Effectiveness Scale of Treatment Satisfaction Questionnaire for Medication (TSQM)|The Effectiveness Scale of the TSQM evaluates the participant’s satisfaction or dissatisfaction (1=extremely dissatisfied to 7=extremely satisfied) with the ability of the medication to prevent or treat the condition, the way the medication relieves symptoms, the amount of time it takes for the medication to start working, and other questions. Scores are converted to a range of 0 to 100. A higher score indicates greater satisfaction.|Week 96|Participants who had values at Week 96 were included in the analysis.||Scores on a scale||Standard Deviation|Mean
770409|NCT00711009|Secondary|Change From Baseline on Mental Component of Medical Outcomes Study HIV Health Survey|The Survey is a brief, comprehensive health status measure used in studies of people with HIV/AIDS. Participants rate their health and mental/emotional condition, how much their health limits physical activities (eating, dressing, bathing, climbing stairs, walking one block, etc.) and social activities (visiting with friends or relatives, etc.), and other questions that measure quality of life. The mental component summarizes answers to questions about emotional and mental wellbeing. Possible scores range from 0 to 100. Higher scores indicates better health, and increases indicate improvement.|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||Scores on a scale||Standard Error|Mean
770410|NCT00711009|Secondary|Change From Baseline on Physical Component Score of the Medical Outcomes Study HIV Health Survey|The Survey is a brief, comprehensive health status measure used in studies of people with HIV/AIDS. Participants rate their health and mental/emotional condition, how much their health limits physical activities (eating, dressing, bathing, climbing stairs, walking one block, etc.) and social activities (for example, visiting with friends or relatives), and other questions that measure quality of life. The physical component summarizes answers to questions about physical status. Possible scores range from 0 to 100. A higher score indicates better health, and increases indicate improvement.|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||Scores on a scale||Standard Error|Mean
770411|NCT00711009|Secondary|Number of Participants Who Developed Resistance, Defined Conservatively, to Lopinavir|Beginning at Week 8, if participant's plasma HIV-1 RNA was greater than/equal to 40 copies/milliliter (mL) and was below 40 copies/mL at the previous visit, additional procedures were undertaken to determine if resistance occurred. Evidence of lopinavir resistance was more conservatively defined as the presence of 1 or more of these mutations: protease I47V or A, G48V, I50V, V82A or F or T or S, I84V, L90M; or presence of at least 3 or more of these mutations: protease L10F or I or R or V, K20M or R, L24I, V32I, L33F, M36I, M46I or L, F53L, any change to I54, A71V or T, and G73S.|Baseline to Week 96|The population for each group was the number of participants who met the criteria for resistance testing, that is, participants whose HIV-RNA increased from <40 copies/mL to >=40 copies/mL at a later visit and who underwent additional genotyping for resistance to one of the study drugs the participant was receiving.||Participants|||Number
770412|NCT00711009|Secondary|Number of Participants Who Developed Resistance to Each Drug in the Study Regimen, as Defined by the International AIDS Society-USA (IAS-USA) Panel.|Resistance to study drugs was defined as described by the International AIDS Society-USA (IAS-USA) Panel. All participants had an HIV-1 drug resistance genotype (lopinavir/ritonavir, tenofovir, or emtricitabine) obtained at the Screening Visit. Beginning at Week 8, if participant's plasma HIV-1 RNA was greater than or equal to 40 copies/milliliter (mL) and was below 40 copies/mL at the previous visit, additional procedures were undertaken to determine if resistance to study drug occurred.|Baseline to Week 96|The population for each group was the number of participants who met the criteria for resistance testing, that is, participants whose HIV-RNA increased from <40 copies/ml to >=40 copies/mL at a later visit and who underwent additional genotyping for resistance to one of the study drugs the participant was receiving.||Participants|||Number
770413|NCT00711009|Secondary|Time to Loss of Virologic Response - Percentage of Participants Still Categorized as Responders at Day 672|Time of loss of virologic response was defined as the first of the following: first of 2 consecutive visits with plasma HIV-1 RNA greater than or equal to 40 copies/milliliter (mL), if the participant previously demonstrated 2 consecutive plasma HIV-1 RNA levels below 40 copies/mL; Study Day 1, if the subject never achieved 2 consecutive plasma HIV-1 RNA levels below 40 copies/mL; the day of the final measurement, if the final measurement was the first one documenting an increase in plasma HIV-1 RNA level to greater than or equal to 40 copies/mL.|Baseline to Week 96|Intent to treat (ITT) population, defined as all randomized participants who received at least 1 dose of study drug.||Percentage of Participants|||Number
778133|NCT00774163|Primary|Serum Creatinine||Day 5|||mg/dl||Standard Deviation|Mean
778134|NCT00774163|Primary|Blood Urea Nitrogen||Day 5|||mg/dl||Standard Deviation|Mean
770414|NCT00711009|Secondary|Mean Change in CD4+ T-Cell Counts From Baseline to Each Visit||Baseline to Week 96|Participants who had values at Baseline and the visit were included in the analysis of data at that visit. Number of participants in each visit analysis ranged from 98 and 96 participants in the LPV/r+FTC/TDF and LPV/r+RAL groups, respectively, at Week 8, to 80 and 76 participants in the LPV/r+FTC/TDF and LPV/r+RAL groups, respectively, at Week 96.||cells/microliter||Standard Error|Mean
770415|NCT00711009|Primary|Primary Outcome: Percentage of Participants With Potentially Clinically Significant Laboratory Values|Potentially clinically significant laboratory values that occurred in at least 2% of participants in either treatment arm are presented.|Baseline to Week 96|All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline laboratory value.||Percentage of participants|||Number
770416|NCT00711009|Secondary|Percentage of Participants Responding (Plasma HIV-1 RNA Levels Below 40 Copies/Milliliter [mL]) at Each Visit Based on the FDA Time to Loss of Virologic Response (TLOVR) Algorithm|A participant was classified as a responder at the first of 2 consecutive visits with plasma HIV-1 RNA levels below 40 copies/mL. The participant continued to be a responder until one of the following: 1) the participant had 2 consecutive values greater than or equal to 40 copies/mL; the final measurement, if the final measurement was the first one documenting an increase in plasma HIV-1 RNA level to greater than or equal to 40 copies/mL; the participant discontinued participation in the study or died.|Baseline to Week 96|Intention to treat analysis of all randomized participants who received at least 1 dose of study drug.||Percentage of Participants|||Number
770417|NCT00711009|Primary|Percentage of Participants With Moderate or Severe Treatment-emergent, Drug-related Adverse Events|Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug. Treatment-emergent, moderate or severe drug-related adverse events that occurred in at least 2% of participants in either treatment arm are presented.|Week 96|Intent to treat (ITT) population, defined as all randomized participants who received at least 1 dose of study drug.||Percentage of participants|||Number
770418|NCT00711009|Primary|Percentage of Participants Responding (Plasma HIV-1 Ribonucleic Acid [RNA] Levels Less Than 40 Copies/Milliliter [mL]) at Week 48 Based on the Food and Drug Administration (FDA) Time to Loss of Virologic Response (TLOVR) Algorithm|A participant was classified as a responder at the first of 2 consecutive visits with plasma HIV-1 RNA levels below 40 copies/mL. The participant continued to be a responder until one of the following: the participant had 2 consecutive values greater than or equal to 40 copies/mL; the final measurement, if the final measurement was the first one documenting an increase in plasma HIV-1 RNA level to greater than or equal to 40 copies/mL; the participant discontinued participation in the study or died.|Baseline to Week 48|Intent to treat (ITT) population, defined as all randomized participants who received at least 1 dose of study drug.||Percentage of Participants|||Number
770419|NCT00711022|Primary|Implant Survival Rate|An implant that has failed to osseointegrate, lost its osseointegration or fractured was considered a failure effective from the date of removal. The survival rate for individual implants was analyzed at each visit. Cumulative implant survival rate was calculated using Kaplan-Meier life-table estimation and reported as percentage of survived implants.|At 5-year follow-up|Per protocol analysis presented, this includes implants loaded within 24 hours from implant placement (306 implants in 51 subjects), of these 20 implants failed during the 5 year follow-up period.||percentage of implants|Participants||Number
770420|NCT00711087|Primary|A Change in DLPP of 20cm H2O at Day 30 and Day 120 in the BTX-A Injected Group (Group 1) Compared to the Sham Saline Injected Group (Group 2).|This outcome measure was not able to be determined due to the subject being lost to follow-up. The subject no longer returns phone calls or visits the clinic.|2.5 years|Early spinal cord injury|||||
770421|NCT00711100|Primary|Abstinence From Cigarettes|Abstinence from cigarettes during Abstinence Phase.|Survival (abstinence) at 3 weeks (2 weeks intervention and 1 week follow-up)|At the end of Sampling Phase, subjects chose a preferred product to use during a two week Abstinence Phase. Abstinence from cigarettes was determined during the 2 week study product phase (e.g., Abstinence Phase) and 1 week after this phase.||Participants|||Count of Participants
770422|NCT00711100|Primary|Product Preference|Number of individuals who selected each of the products (e.g., Camel Snus, Marlboro Snus, General Snus, Ariva, Stonewall).|2 weeks|||participants|||Number
770423|NCT00711113|Primary|Marginal Bone Adaptation|Marginal bone adaptation was expressed as the distance from the implant reference point to the most coronal bone-to-implant contact on the mesial and distal side of the implant. Bone adaptation in millimeters at follow-up visit were compared to values obtained Baseline (loading). Positive value indicates bone gain and negative value bone loss.|At baseline (loading) and at 5 year follow-up|Per protocol analysis presented and this includes implants loaded 0 to 56 days from implant placement (80 implants in 32 patients). At 5-year follow-up, 27 patients were still in the study and thus evaluable for the analysis.||Millimeter|Participants|Standard Deviation|Mean
770424|NCT00711113|Primary|Implant Stability|Implant stability was evaluated using Resonance Frequency Analysis (RFA). The RFA value was automatically translated into an Implant Stability Quotient index (ISQ), which runs from 1 to 100. The ISQ value indicates the level of stability. Low values (<60) indicate low stability, medium values (60-70) indicate medium stability and high values (>70) indicate high stability.|At 1 year follow-up|Per protocol analysis presented, this includes implants loaded 0 to 56 days from implant placement (80 implants in 32 patients). At 1-year follow-up, 32 patients were still in the study and thus evaluable for the analysis.||units on a scale|Participants|Standard Deviation|Mean
770425|NCT00711113|Primary|Implant Survival Rate|An implant that has failed to osseointegrate, lost its osseointegration or fractured was considered a failure effective from the date of removal. The survival rate for individual implants was analyzed at each visit. Cumulative implant survival rate was calculated using Kaplan-Meier life-table estimation and reported as percentage of survived implants.|At 5 year follow-up|Per protocol analysis presented, this includes implants loaded 0 to 56 days from implant placement (80 implants in 32 patients), of these three implants failed during the 5 year follow-up period.||percentage of implants|Participants||Number
770426|NCT00711191|Other Pre-specified|Recommended Phase 2 Dose (RP2D) of CP-870893 in Participants With Advanced Pancreas Cancer|Additional participants enrolled at MTD of CP-870893 to further characterize suitability for phase 2 testing. RP2D confirmed if ≤ 3 our of 12 participants in expansion cohort experience DLT in cycle 1.|Baseline up to time of determination of maximum tolerated dose (MTD)|Safety population||mg/kg|||Number
770427|NCT00711191|Secondary|Carbohydrate Antigen 19-9 (CA 19-9)|CA 19-9 or sialylated Lewis (a) antigen (a tumor marker). Values higher than 37 units per milliliter (U/ml) considered abnormal; higher values usually indicate greater presence of disease.|At the end of every even-numbered cycle (cycle=28 days) and 4 to 6 weeks following initial documentation of response|No analyses of these parameters were performed due to the Sponsor's decision to terminate clinical evaluation of CP-870893.|||||
770428|NCT00711191|Secondary|18-fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) Imaging (MTD Expansion Cohort)|FDG PET assessment to characterize and monitor tumors before and after study treatment; measured as a standardized uptake value (SUV). A reduction in SUV from baseline for at least 1 tumor may indicate a positive metabolic response to treatment.|Baseline, Week 2, Week 8, and Single Time Point (STP) PET for all PET scans after Week 8|No analyses of these parameters were performed due to the Sponsor's decision to terminate clinical evaluation of CP-870893.|||||
770429|NCT00711191|Secondary|Change (Pre-dose to Post-dose) in Bone Marrow Derived Cells (B Cell) Surface Markers: CD54, CD23, CD40, CD86, and Human Leukocyte Antigen (HLA-DR)|Assess the ability of PF-870893 to activate B-cells and HLA-DR which are involved in the production of antibodies. Change calculated as mean of pre-dose and post-dose values. Positive values indicate greater presence of cells associated with antibody production.|Cycle 1 / Day 1 and Cycle 1 / Day 8 prior to gemcitabine infusion and 6 and 24 hours after EOI; Cycle 1 / Day 3 prior to CP-870893 infusion and 6, 24, and 48 hours after EOI|No analyses of these parameters were performed due to the Sponsor's decision to terminate clinical evaluation of CP-870893.|||||
770430|NCT00711191|Secondary|Total and Neutralizing Human Antihuman Antibody (HAHA) Titer|HAHA assessed as an indicator of immunogenicity to CP-870893.|Prior to infusion of CP-870893 on Day 3 of every cycle up to a maximum of 12 cycles|No analyses of these parameters were performed due to the Sponsor's decision to terminate clinical evaluation of CP-870893.|||||
770431|NCT00711191|Secondary|Change (Pre-dose to Post-dose) in Plasma Cytokine Concentrations: Time of Maximum Concentration (TCYTOMAX)|An increase in values indicates greater cytokine release from cells targeted by the antibody and may be associated with an infusion reaction. Change calculated as mean of pre-dose and maximum post-dose values.|Cycle 1 / Day 1 prior to gemcitabine infusion (0 hour), 5 minutes after EOI and 2, 4, 6, and 24 hours after EOI; Cycle 1 / Day 3 prior to CP-970893 infusion (0 hour), 5 minutes after EOI, and 2, 4, 6, and 24 hours after EOI|No analyses of these parameters were performed due to the Sponsor's decision to terminate clinical evaluation of CP-870893.|||||
770432|NCT00711191|Secondary|Change (Pre-dose to Post-dose) in Plasma Cytokine Concentrations: Pre-dose Concentration (CYTO0), Maximum Concentration (CTYOMAX)|An increase in values indicates greater cytokine release from cells targeted by the antibody and may be associated with an infusion reaction. Change calculated as mean of pre-dose and maximum post-dose values.|Cycle 1 / Day 1 prior to gemcitabine infusion (0 hour), 5 minutes after EOI and 2, 4, 6, and 24 hours after EOI; Cycle 1 / Day 3 prior to CP-970893 infusion (0 hour), 5 minutes after EOI, and 2, 4, 6, and 24 hours after EOI|No analyses of these parameters were performed due to the Sponsor's decision to terminate clinical evaluation of CP-870893.|||||
770433|NCT00711191|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the serum concentration time-curve from time zero to the last measured concentration. AUClast analyzed using a noncompartmental approach to estimate individual participant values.|Cycle 1 / Day 3 pre-dose, 5 minutes after EOI, and 2, 6, and 24 hours after EOI and pre-dose on Day 3 of every subsequent cycle up to a maximum of 12 cycles|No analyses of these parameters were performed due to the Sponsor's decision to terminate clinical evaluation of CP-870893.|||||
770434|NCT00711191|Secondary|Maximum Serum Concentration (Cmax)||Cycle 1 / Day 3 pre-dose, 5 minutes after End of Infusion (EOI), and 2, 6, and 24 hours after EOI and pre-dose on Day 3 of every subsequent cycle up to a maximum of 12 cycles|No analyses of these parameters were performed due to the Sponsor's decision to terminate clinical evaluation of CP-870893.|||||
770435|NCT00711191|Secondary|Time to Progression|Disease progression defined as ≥20% increase in sum LD of target lesions from smallest sum LD recorded since treatment start or appearance of ≥1 new lesions. Criteria for progression also included unequivocal progression of existing nontarget lesions.|Monthly until death or 7.5 months after last participant was enrolled (up to January 2011)|No analyses of these parameters were performed due to the Sponsor's decision to terminate clinical evaluation of CP-870893.|||||
770436|NCT00711191|Secondary|Progression Free Survival (PFS)|PFS is time from baseline to first progression (Prog) or death from any cause. Participants last known to be alive, had not started a new (non-protocol) cancer treatment, were Prog-free, and who had a baseline and ≥1 on-study disease assessment were censored at date of last objective disease assessment that verified lack of Prog. Participants who were off treatment prior to Prog and who had no on-study disease assessment were also censored. Prog: ≥20% increase in sum of longest dimension (LD) of target lesions from smallest sum LD recorded since treatment start or appearance of ≥1 new lesions.|Baseline, assessed monthly until death or 7.5 months after last participant was enrolled (up to January 2011)|Safety population; Kaplan-Meier estimate of time to event 95% CI for 50% quartile based on Brookmeyer and Crowley Method. Criteria for progression also included unequivocal progression of existing nontarget lesions.||months||95% Confidence Interval|Median
770437|NCT00711191|Secondary|Overall Survival (OS)|OS is time from baseline to death from any cause. Participants last known to be alive were censored at the date of last contact.|Baseline, assessed monthly until death or 7.5 months after last participant was enrolled (up to January 2011)|Safety population; Kaplan-Meier estimate of time to event 95 percent confidence interval (95% CI) for 50% quartile based on Brookmeyer and Crowley Method.||months||95% Confidence Interval|Median
770438|NCT00711191|Secondary|Percentage of Participants With Objective Tumor Response According to Response Evaluation Criteria in Solid Tumors (RECIST)|Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.|At the end of every even-numbered cycle (cycle=28 days) up to a maximum of 12 cycles and 4 to 6 weeks following initial documentation of response|Safety population; Confidence Interval (CI) calculated using exact method based on binomial distribution.||percentage of participants||95% Confidence Interval|Number
770439|NCT00711191|Primary|Number of Participants With Dose Limiting Toxicities (DLTs)|"Any of the following during first cycle of treatment and attributable to CP-870893:
afebrile Grade (Gr) 4 neutropenia (absolute neutrophil count [ANC] <500 cells/mm^3) ≥7 days or Gr 3 or 4 neutropenia associated with fever (1 oral temperature >38.5 degrees Celsius (C) or 3 oral temperatures >38.0 degrees C in a 24-hour period); Gr 4 thrombocytopenia or Gr 3 thrombocytopenia associated with bleeding; Gr 4 lymphopenia, if coupled with clinical consequence (such as, opportunistic infection) or any other Gr 3 hematological adverse events; ≥Gr 3 non-hematologic toxicities (except alopecia)."|Baseline up to Cycle 1 / Day 28|Safety population: all participants who received any study treatment. Cubic millimeters (mm^3).||participants|||Number
770440|NCT00711347|Secondary|Surgeon Survey|"Survey completed by the surgeon to evaluate use of the product during surgery. Responses are rated on the following scale and the means of the responses are reported:
Overall surgical difficulty: 1 - very easy; 2 - easy; 3 - neither easy nor difficult; 4 - difficult; 5 - very difficult
Satisfaction with performance: 1 - strongly disagree; 2 - disagree; 3 - undecided/neutral; 4 - agree; 5 - strongly agree
Ability to expand pupil: 1 - not effective; 2 - moderately effective; 3 - very effective"|Time of Surgery|||Units on a scale||Standard Deviation|Mean
770441|NCT00711347|Secondary|Aqueous Signs - Edema|"Aqueous signs refers cornea edema evaluated by the surgeon one day after surgery. Corneal edema is evaluated by the following scale:
0 = none
= mild - slight localized or generalized edema
= moderate - significant localized or generalized edema
= severe - advanced localized or generalized edema"|1 Day Postoperative|14 patients/28 eyes in each group.||Units on a scale||Standard Deviation|Mean
770442|NCT00711347|Secondary|Aqueous Signs - Flare|"Aqueous Flare refers to individual inflammatory cells. Aqueous flare is evaluated by the surgeon one day after surgery and rated on the following scale:
0:No-Visible flare when compared with the normal eye.
Mild-Flare visible against dark papillary background but not visible against iris background.
Moderate-flare is visible with the slit-lamp beam aimed onto the iris surface as well as the dark papillary background.
Severe-Very dense flare. May also present as a hazy appearance of anterior segment structures when viewed with low power magnification of the slit-lamp."|1 Day Postoperative|14 patients/28 eyes in each group.||Units on a scale||Standard Deviation|Mean
770443|NCT00711347|Secondary|Aqueous Signs - Cells|Aqueous Cells are the foggy appearance given by protein that has leaked from inflamed blood vessels. This is evaluated by the surgeon one day post surgery and rated on the following scale: None, 0: 1-5 cells, 1: 6-15 cells, 2: 16-30 cells, 3: >30 cells|1 Day Postoperative|14 patients/28 eyes in each group.||Units on a scale||Standard Deviation|Mean
770444|NCT00711347|Secondary|Intraocular Pressure (IOP)|Intraocular Pressure (IOP) is assessed with a slit lamp by means of Applanation (Goldmann) tonometry. This type of tonometry uses a small probe to gently flatten part of your cornea to measure eye pressure. The pressure in your eye is measured by how much force is needed to flatten your cornea, and measured in millimeters of mercury (mmHg). Normally, IOP should be less than 21 mmHg.|1 Day Postoperative|14 patients/28 eyes in each group.||mmHg||Standard Deviation|Mean
770445|NCT00711347|Primary|Corneal Endothelial Cell Loss|Endothelial cell loss/gain is measured by comparing the preoperative assessment of endothelial cell density against postoperative measurements. Measurements are made with a specular microscope, which takes a picture and numbers endothelial cells. This endpoint compares the assessment done at 1 month against the assessment done at baseline. A negative number indicates a loss of endothelial cells, a positive number indicates a gain in endothelial cells.|1 month|14 patients/28 eyes in each group.||Percent change||Standard Deviation|Mean
770446|NCT00711425|Primary|Marginal Bone Adaptation|Marginal bone adaptation will be expressed as the distance from the implant reference point to the most coronal bone-to-implant contact on the mesial and distal side of the implant. Bone adaptation in millimeters at follow-up visit will be compared to values obtained Baseline (loading). Positive value indicates bone gain and negative value bone loss.|At 5 year follow-up|Per protocol analysis presented, this includes implants loaded 0 to 56 days from implant placement (134 implants in 44 patients). At 5-year follow-up, 41 patients were still in the study and thus evaluable for the analysis.||Millimeter|Participants|Standard Deviation|Mean
770447|NCT00711425|Primary|Implant Stability|Implant stability will be evaluated using Resonance Frequency Analysis (RFA). The RFA value is automatically translated into an Implant Stability Quotient index (ISQ), which runs from 1 to 100.|At 1 year follow-up|Per protocol analysis presented, this includes implants loaded 0 to 56 days from implant placement (134 implants in 44 patients).At 1-year follow-up, 43 patients were still in the study and thus evaluable for the analysis.||ISQ|Participants|Standard Deviation|Mean
770448|NCT00711425|Primary|Implant Survival Rate|An implant that has failed to osseointegrate, lost its osseointegration or fractured will be considered a failure effective from the date of removal. The survival rate for individual implants will be analyzed at each visit. Cumulative implant survival rate will be calculated using Kaplan-Meier life-table estimation and reported as percentage of survived implants.|At 5 year follow-up|Per protocol analysis presented, this includes implants loaded 0 to 56 days from implant placement (134 implants in 44 patients).||Percentage of implants|Participants||Number
770449|NCT00711464|Secondary|Heart Rate|beats per minute|3-5 hours|||beats per minute||Standard Deviation|Mean
770450|NCT00711464|Secondary|Systolic Blood Pressure|systolic blood pressure in mm Hg|3-5 hours|||mm Hg||Standard Deviation|Mean
770451|NCT00711464|Primary|Cognitive Performance|Percent Accuracy on high-control (i.e. difficult) condition on test of cognitive control|3-5 hours|||percentage correct of all trials||Standard Deviation|Mean
770452|NCT00711477|Primary|Response to Food Related Cues Using Functional Magnetic Resonance Imaging - Posterior Insula|Assessment of differences in brain activation in response to food cues before and after 4 weeks of treatment in subjects receiving NB or placebo.|Baseline, 4 weeks|ITT (Intent-to-Treat): Included all subjects who were randomized, had a baseline measurement, and had at least one post-baseline fMRI measurement during the defined treatment phase.||percent activation||90% Confidence Interval|Mean
770453|NCT00711477|Primary|Response to Food Related Cues Using Functional Magnetic Resonance Imaging - Superior Parietal|Assessment of differences in brain activation in response to food cues before and after 4 weeks of treatment in subjects receiving NB or placebo.|Baseline, 4 weeks|ITT (Intent-to-Treat): Included all subjects who were randomized, had a baseline measurement, and had at least one post-baseline fMRI measurement during the defined treatment phase.||percent activation||90% Confidence Interval|Mean
778135|NCT00774163|Primary|Serum AST in Males||Day 5|limited to males||units per liter (U/L)||Standard Deviation|Mean
770454|NCT00711477|Primary|Response to Food Related Cues Using Functional Magnetic Resonance Imaging - Hippocampal Region 2|Assessment of differences in brain activation in response to food cues before and after 4 weeks of treatment in subjects receiving NB or placebo.|Baseline, 4 weeks|ITT (Intent-to-Treat): Included all subjects who were randomized, had a baseline measurement, and had at least one post-baseline fMRI measurement during the defined treatment phase.||percent activation||90% Confidence Interval|Mean
770455|NCT00711477|Primary|Response to Food Related Cues Using Functional Magnetic Resonance Imaging - Hippocampal Region 1|Assessment of differences in brain activation in response to food cues before and after 4 weeks of treatment in subjects receiving NB or placebo.|Baseline, 4 weeks|ITT (Intent-to-Treat): Included all subjects who were randomized, had a baseline measurement, and had at least one post-baseline fMRI measurement during the defined treatment phase.||percent activation||90% Confidence Interval|Mean
770456|NCT00711477|Primary|Response to Food Related Cues Using Functional Magnetic Resonance Imaging - Anterior Cingulate|Assessment of differences in brain activation in response to food cues before and after 4 weeks of treatment in subjects receiving NB or placebo.|Baseline, 4 weeks|ITT (Intent-to-Treat): Included all subjects who were randomized, had a baseline measurement, and had at least one post-baseline fMRI measurement during the defined treatment phase.||percent activation||90% Confidence Interval|Mean
770457|NCT00711477|Secondary|Change in Question 19 From 21-Item COE (Control of Eating) Questionnaire|Question 19: Generally, how difficult has it been to control your eating? Scoring: 0=not at all difficult; 100=extremely difficult|Baseline, 4 weeks|ITT (Intent-to-Treat): Included all subjects who were randomized, had a baseline measurement, and had at least one post-baseline fMRI measurement during the defined treatment phase.||units on a scale||Standard Error|Least Squares Mean
770458|NCT00711477|Secondary|Dutch Eating Behavior Questionnaire - Change in External Eating Subscale Score|The Dutch Eating Behavior Questionnaire is a 33-item self-report measure designed to assess the type of eating behavior and is organized into 3 subscales (emotional eating, externally-induced eating, and restrained eating). Subjects rated the frequency of their eating behaviors using a 5-point scale where 1=never, 2=seldom, 3=sometimes, 4=often, and 5=very often. The External Eating subscale consisted of 10 items and the scores ranged from 10 (better outcome) to 50 (worse outcome).|Baseline, 4 weeks|ITT (Intent-to-Treat): Included all subjects who were randomized, had a baseline measurement, and had at least one post-baseline fMRI measurement during the defined treatment phase.||units on a scale||Standard Error|Least Squares Mean
770459|NCT00711477|Secondary|Dutch Eating Behavior Questionnaire - Change in Emotional Eating B Subscale Score|The Dutch Eating Behavior Questionnaire is a 33-item self-report measure designed to assess the type of eating behavior and is organized into 3 subscales (emotional eating, externally-induced eating, and restrained eating). Subjects rated the frequency of their eating behaviors using a 5-point scale, where 1=never, 2=seldom, 3=sometimes, 4=often, and 5=very often. The Emotional Eating B subscale (diffuse emotions) consisted of 4 items and the scores ranged from 4 (better outcome) to 20 (worse outcome).|Baseline, 4 weeks|ITT (Intent-to-Treat): Included all subjects who were randomized, had a baseline measurement, and had at least one post-baseline fMRI measurement during the defined treatment phase.||units on a scale||Standard Error|Least Squares Mean
770460|NCT00711477|Secondary|Dutch Eating Behavior Questionnaire - Change in Emotional Eating A Subscale Score|The Dutch Eating Behavior Questionnaire is a 33-item self-report measure designed to assess the type of eating behavior and is organized into 3 subscales (emotional eating, externally-induced eating, and restrained eating). Subjects rated the frequency of their eating behaviors using a 5-point scale, where 1=never, 2=seldom, 3=sometimes, 4=often, and 5=very often. The Emotional Eating A subscale (clearly labeled emotions) consisted of 9 items and the scores ranged from 9 (better outcome) to 45 (worse outcome).|Baseline, 4 weeks|ITT (Intent-to-Treat): Included all subjects who were randomized, had a baseline measurement, and had at least one post-baseline fMRI measurement during the defined treatment phase.||units on a scale||Standard Error|Least Squares Mean
770461|NCT00711477|Secondary|Dutch Eating Behavior Questionnaire - Change in Restrained Eating Subscale Score|The Dutch Eating Behavior Questionnaire is a 33-item self-report measure designed to assess the type of eating behavior and is organized into 3 subscales (emotional eating, externally-induced eating, and restrained eating). Subjects rated the frequency of their eating behaviors using a 5-point scale, where 1=never, 2=seldom, 3=sometimes, 4=often, and 5=very often. The Restrained Eating subscale consisted of 10 items and the scores ranged from 10 (worse outcome) to 50 (better outcome).|Baseline, 4 weeks|ITT (Intent-to-Treat): Included all subjects who were randomized, had a baseline measurement, and had at least one post-baseline fMRI measurement during the defined treatment phase.||units on a scale||Standard Error|Least Squares Mean
770462|NCT00711477|Secondary|Percent Change in Body Weight||Baseline, 4 weeks|ITT (Intent-to-Treat): Included all subjects who were randomized, had a baseline measurement, and had at least one post-baseline fMRI measurement during the defined treatment phase.||percentage of body weight||Standard Error|Least Squares Mean
770463|NCT00711477|Primary|Response to Food Related Cues Using Functional Magnetic Resonance Imaging - Superior Frontal|Assessment of differences in brain activation in response to food cues before and after 4 weeks of treatment in subjects receiving NB or placebo.|Baseline, 4 weeks|ITT (Intent-to-Treat): Included all subjects who were randomized, had a baseline measurement, and had at least one post-baseline fMRI measurement during the defined treatment phase.||percent activation||90% Confidence Interval|Mean
770464|NCT00711490|Secondary|Change in Fluid Leakage in the Macula of the Study Eye From Baseline to 12 Months, as Measured on Fluorescein Angiography (FA)||12 months||||||
770465|NCT00711490|Secondary|Change in Fluid Leakage in the Macula of the Study Eye From Baseline to 6 Months, as Measured on Fluorescein Angiography (FA)||6 months||||||
770466|NCT00711490|Secondary|Change in Retinal Thickness From Baseline to 12 Months, as Measured by Optical Coherence Tomography (OCT)|Retinal thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|12 months|||μm||Full Range|Median
770467|NCT00711490|Secondary|Change in Retinal Thickness From Baseline to 6 Months, as Measured by Optical Coherence Tomography (OCT)|Retinal thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|6 months|||μm||Full Range|Median
770468|NCT00711490|Secondary|Change in Visual Acuity From Baseline to 12 Months|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. This acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters the Snellen measurement is 20/20.|12 months|||ETDRS letters||Full Range|Median
770469|NCT00711490|Primary|Change in Visual Acuity From Baseline to 6 Months|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. This acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters the Snellen measurement is 20/20.|6 months|||ETDRS letters||Full Range|Median
770470|NCT00711516|Secondary|Change From Baseline to Endpoint (2 Weeks or Last Observation After Baseline) in the Mean Response Latency in the Psychomotor Vigilance-Like Test|During anatomic scanning (and prior to functional runs when anatomic scanning was not performed), a modified continuous 10 minute attention task (“Psychomotor Vigilance Test [PVT]-like task,” nearly identical to the PVT but for absence of performance feedback) was run to obtain a measure of vigilance in the scanner—in this instance, the “+” symbol appeared at random (mean inter trial interval of 5 seconds, range 2 - 10 seconds) but disappeared when subject pressed a button. Subject performance speed was measured. Change in subject performance speed from Baseline to Endpoint is presented.|Baseline and Endpoint (Week 2 or last observation after Baseline)|Full Analysis Set defined as subjects who had at least one observation after Baseline||milliseconds (ms)||Standard Error|Least Squares Mean
770471|NCT00711516|Secondary|Change From Baseline to Endpoint in the Number of Voxels Meeting Predefined Threshold in the Thalamus at Resting State|At resting state, this is an analysis of the change from Baseline to Endpoint in the number of activated voxels meeting predefined threshold (voxels that differ significantly from reference wave form) on functional magnetic resonance imaging (fMRI) in the thalamus.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects with at least one observation after Baseline||Voxels||Full Range|Median
770472|NCT00711516|Secondary|Change From Baseline to Endpoint in the Number of Voxels Meeting Predefined Threshold in Posterior Parietal Cortex (PPC) at Resting State|At resting state, this is an analysis of the change from Baseline to Endpoint in the number of activated voxels meeting predefined threshold (voxels that differ significantly from reference wave form) on functional magnetic resonance imaging (fMRI) in the posterior parietal cortex (PPC).|Baseline and Endpoint (Week 2 or last observation after Baseline)|Full Analysis Set defined as subjects with at least one observation after Baseline||Voxels||Full Range|Median
770473|NCT00711516|Secondary|Change From Baseline to Endpoint in the Number of Voxels Meeting Predefined Threshold in Anterior Cingulate Cortex (ACC) at Resting State|At resting state, this is an analysis of the change from Baseline to Endpoint in the number of contiguous activated voxels meeting pre-defined threshold (voxels that differ significantly from reference wave form) on functional magnetic resonance imaging (fMRI) in the anterior cingulate cortex (ACC).|Baseline and Endpoint (Week 2 or last observation after Baseline)|Full Analysis Set defined as subjects with at least one observation after Baseline||Voxels||Full Range|Median
770474|NCT00711516|Secondary|Change From Baseline to Endpoint in the Number of Voxels Meeting Predefined Threshold in the Dorsolateral Prefrontal Cortex (DLPFC) at Resting State|At resting state, this is an analysis of the change from Baseline to Endpoint in the number of contiguous activated voxels (voxels that differ significantly from reference wave form) on functional magnetic resonance imaging (fMRI) in the dorsolateral prefrontal cortex.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one observation after Baseline||Voxels||Full Range|Median
770475|NCT00711516|Secondary|Change From Baseline to Endpoint in the BOLD Signal Intensity in the Thalamus at Resting State|At resting state, this is an analysis of the change from Baseline to Endpoint in the blood oxygen level dependent (BOLD) signal intensity in the thalamus.|Baseline and Endpoint (Week 2 or last observation after Baseline)|Full Analysis Set defined as subjects who have had at least one observation after Baseline||BOLD signal intensity||Full Range|Median
770476|NCT00711516|Secondary|Change From Baseline in the BOLD Signal Intensity in the Posterior Parietal Cortex (PPC) at Resting State|At resting state, this is an analysis of the change from Baseline to Endpoint in the blood oxygen level dependent (BOLD) signal intensity in the posterior parietal cortex (PPC).|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who have had at least one observation after Baseline||BOLD signal intensity||Full Range|Median
770477|NCT00711516|Secondary|Change From Baseline to Endpoint in the BOLD Signal Intensity in the Anterior Cingulate Cortex (ACC) at Resting State|At resting state, this is an analysis of the change from Baseline to Endpoint in the blood oxygen level dependent signal (BOLD) intensity in the anterior cingulate cortex (ACC).|Baseline and Endpoint (Week 2 or last observation after Baseline)|Full Analysis Set defined as subjects who had at least one observation after baseline||BOLD signal intensity||Full Range|Median
770478|NCT00711516|Secondary|Change From Baseline to Endpoint in the BOLD Signal Intensity in the Dorsolateral Prefrontal Cortex (DLPFC) at Resting State|At resting state, this is an analysis of the change from Baseline to Endpoint in the blood oxygen level dependent (BOLD) signal intensity in the dorsolateral prefrontal cortex (DLPFC).|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one observation after baseline||BOLD signal intensity||Full Range|Median
770479|NCT00711516|Secondary|Number of Contiguous Activated Voxels Meeting Predefined Threshold in the Thalamus on fMRI by 2-Back Working Memory Test-Change From Baseline; Subgroup-Non Responders in 2 Back Memory Test|This is a subgroup analysis of non-responders on the 2-back working memory test for the number of voxels meeting the predefined threshold (voxels that differ significantly from reference wave form) on functional magnetic resonance imaging (fMRI). A non-responder in the 2-back working memory test was defined as a patient showing a response latency of 713 ms or greater at endpoint. The change from Baseline to Endpoint in the number of activated voxels in the thalamus for each treatment group among the non-responders is presented.|Baseline and Endpoint (Week 2 or last observation after baseline)|Sub-group analysis of non-responders on the 2-Back Working Memory Test (response latency of 713 ms or greater) at Endpoint||Voxels||Standard Error|Mean
771006|NCT00721188|Primary|Area Under the Serum Concentration-time Curve From Time of Dosing to the Last Quantifiable Measurable Serum Concentration (AUC 0-last)||Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.|||ug*hr/dL||Standard Deviation|Mean
770480|NCT00711516|Secondary|Number of Contiguous Activated Voxels Meeting Predefined Threshold in the PPC on fMRI by 2-Back Working Memory Test-Change From Baseline; Subgroup-Non Responders in 2 Back Memory Test|This is a subgroup analysis of non-responders on the 2-back working memory test for the number of voxels meeting the predefined threshold (voxels that differ significantly from reference wave form) on functional magnetic resonance imaging (fMRI). A non-responder in the 2-back working memory test was defined as a patient showing a response latency of 713 ms or greater at endpoint. The change from Baseline to Endpoint in the number of activated voxels in the posterior parietal cortex (PPC)for each treatment group among the non-responders is presented.|Baseline and Endpoint (Week 2 or last observation after baseline)|Sub-group analysis of non-responders on the 2-Back Working Memory Test (response latency of 713 ms or greater) at Endpoint||Voxels||Standard Error|Mean
770481|NCT00711516|Secondary|Number of Contiguous Activated Voxels Meeting Predefined Threshold in the ACC on fMRI by 2-Back Working Memory Test-Change From Baseline; Subgroup-Non Responders in 2 Back Memory Test|This is a subgroup analysis of non-responders on the 2-back working memory test for the number of voxels meeting the predefined threshold (voxels that differ significantly from reference wave form) on functional magnetic resonance imaging (fMRI). A non-responder in the 2-back working memory test was defined as a patient showing a response latency of 713 ms or greater at endpoint. The change from Baseline to Endpoint in the number of activated voxels in the anterior cingulate cortex (ACC)for each treatment group among the non-responders is presented.|Baseline and Endpoint (Week 2 or last observation after baseline)|Sub-group analysis of non-responders on the 2-Back Working Memory Test (response latency of 713 ms or greater) at Endpoint||Voxels||Standard Error|Mean
770482|NCT00711516|Secondary|Number of Contiguous Activated Voxels Meeting Predefined Threshold in the DLPFC on fMRI by 2-Back Working Memory Test-Change From Baseline; Subgroup-Non Responders in 2 Back Memory Test|This is a subgroup analysis of non-responders on the 2-back working memory test for the number of voxels meeting the predefined threshold (voxels that differ significantly from reference wave form) on functional magnetic resonance imaging (fMRI). A non-responder in the 2-back working memory test was defined as a patient showing a response latency of 713 ms or greater at endpoint. The change from Baseline to Endpoint in the number of activated voxels in the dorsolateral prefrontal cortex (DLPFC)for each treatment group among the non-responders is presented.|Baseline and Endpoint (Week 2 or last observation after baseline)|Sub-group analysis among non-responders on the 2-Back Working Memory Test (response latency of 713 ms or greater) at Endpoint||Voxels||Standard Error|Mean
770483|NCT00711516|Secondary|Number of Contiguous Activated Voxels Meeting Predefined Threshold in the Thalamus on fMRI by 2-Back Working Memory Test-Change From Baseline; Subgroup-Responders in 2 Back Memory Test|This is a subgroup analysis of responders on the 2-back working memory test for the number of activated voxels (voxels that differ significantly from reference wave form) in the thalamus. A responder in the 2-back working memory test was defined as a patient showing a response latency of less than 713 ms at endpoint. This is based on baseline data from the matched control population in a functional imaging study in patients with obstructive sleep apnea. The change from Baseline to Endpoint in the number of activated voxels for each treatment group among the responders is presented.|Baseline and Endpoint (Week 2 or last observation after baseline)|Sub-group Analysis of subjects who were responders on the 2-Back Working Memory Test (response latency < 713 ms) at Endpoint||Voxels||Standard Error|Mean
770484|NCT00711516|Secondary|Number of Contiguous Activated Voxels Meeting Predefined Threshold in the PPC on fMRI by 2-Back Working Memory Test-Change From Baseline; Subgroup-Responders in 2 Back Memory Test|This is a subgroup analysis of responders on the 2-back working memory test for the number of voxels (voxels that differ significantly from reference wave form) in Posterior Parietal Cortex (PPC). A responder in the 2-back working memory test was defined as a patient showing a response latency of less than 713 ms at endpoint. This is based on baseline data from the matched control population in a functional imaging study in patients with obstructive sleep apnea. The change from Baseline to Endpoint in the number of activated voxels for each treatment group among the responders is presented.|Baseline and Endpoint (Week 2 or last observation after baseline)|Sub-group Analysis of subjects who were responders on the 2-Back Working Memory Test (had a response latency < 713 ms) at Endpoint||Voxels||Standard Error|Mean
770485|NCT00711516|Secondary|Number of Contiguous Activated Voxels Meeting Predefined Threshold in the ACC on fMRI by 2-Back Working Memory Test -Change From Baseline; Subgroup-Responders in 2 Back Memory Test|This is a subgroup analysis of responders on the 2-back working memory test for the number of activated voxels (that differ significantly from reference wave form) in Anterior Cingulate Cortex (ACC). A responder in the 2-back working memory test was defined as a patient showing a response latency of less than 713 ms at endpoint. This is based on baseline data from the matched control population in a functional imaging study in patients with obstructive sleep apnea. The change from Baseline to Endpoint in the number of activated voxels for each treatment group among the responders is presented.|Baseline and Endpoint (Week 2 or last observation after baseline)|Sub-group Analysis of subjects who were responders on the 2-Back Working Memory Test (had response latency < 713 ms) at Endpoint||Voxels||Standard Error|Mean
770486|NCT00711516|Secondary|Number of Contiguous Activated Voxels Meeting Predefined Threshold in the DLPFC on fMRI on the 2 Back Working Memory Test - Change From Baseline-Subgroup-Responders in 2 Back Working Memory Test|This is a subgroup analysis of responders on the 2-back working memory test for the number of voxels meeting the predefined threshold in DLPFC. A responder in the 2-back working memory test was defined as a patient showing a response latency of less than 713 ms at endpoint. This is based on baseline data from the matched control population in a functional imaging study in patients with obstructive sleep apnea. The change from Baseline to Endpoint in the number of activated voxels (that differ significantly from reference wave form) for each treatment group among the responders is presented.|Baseline and Endpoint (Week 2 or last observation after baseline)|Sub-group Analysis of subjects who were responders on the 2-Back Working Memory Test defined as subjects who had a response latency of < 713 ms at Endpoint||Activated voxels||Standard Error|Mean
770487|NCT00711516|Secondary|Activation-Performance Relationship on Functional Magnetic Resonance Imaging (fMRI) in the Thalamus and 2-Back Working Memory Test - Blood Oxygen Level Dependent (BOLD) Signal Intensity at Endpoint|With this outcome measure the correlation between BOLD signal intensity on fMRI in the thalamus versus performance on the 2-back working memory test was evaluated for both Armodafinil and Placebo. Correlation coefficients and P-values are presented for each treatment group.|Week 2 or Last Observation after Baseline|Full Analysis Set defined as subjects with at least one observation after baseline||Correlation Coefficient|||Number
770488|NCT00711516|Secondary|Activation-Performance Relationship on Functional Magnetic Resonance Imaging (fMRI) in Posterior Parietal Cortex (PPC) and 2-Back Working Memory Test - Blood Oxygen Level Dependent (BOLD) Signal Intensity at Endpoint|With this outcome measure the correlation between the BOLD signal intensity on fMRI in PPC versus performance on the 2-back working memory test was evaluated for both Armodafinil and Placebo. Correlation coefficients and P-values are presented for each treatment group.|Week 2 or Last Observation after Baseline|Full Analysis Set defined as subjects with at least one observation after baseline||Correlation Coefficient|||Number
770489|NCT00711516|Secondary|Activation-Performance Relationship Between Functional Magnetic Resonance Imaging (fMRI) in Anterior Cingulate Cortex (ACC) and 2-Back Working Memory Test -Blood Oxygen Level Dependent (BOLD) Signal Intensity at Endpoint|With this outcome measure the correlation between the BOLD signal intensity on fMRI in the ACC versus performance on the 2-back working memory test was evaluated for both Armodafinil and Placebo. Correlation coefficients and P-values are presented for each treatment group.|Week 2 or Last Observation after Baseline|Full Analysis Set defined as subjects with at least one observation after baseline||Correlation Coefficient|||Number
770490|NCT00711516|Secondary|Activation-Performance Relationship Between the Functional Magnetic Resonance Imaging (fMRI) in Dorsolateral Prefrontal Cortex (DLPFC) and 2-Back Working Memory Test - Blood Oxygen Level Dependent (BOLD) Signal Intensity at Endpoint|With this outcome measure the correlation between the BOLD signal intensity on fMRI over DLPFC versus performance on the 2-back working memory test was evaluated for both Armodafinil and Placebo. Correlation coefficients and P-values are presented for each treatment group.|Week 2 or Last Observation after Baseline|Full Analysis Set defined as subjects with at least one observation after baseline||Correlation Coefficient|||Number
770491|NCT00711516|Secondary|Activation-Performance Relationship Between Functional Magnetic Resonance Imaging (fMRI) in the Thalamus and 2-Back Working Memory Test -Number of Voxels Activated at Endpoint|With this outcome measure the correlation between the number of voxels activated on fMRI (voxels that differ significantly from reference wave form) in the thalamus versus performance on the 2-back working memory test was evaluated for both Armodafinil and Placebo. Correlation coefficients and P-values are presented for each treatment group.|Week 2 or Last Observation after Baseline|Full Analysis Set defined as subjects with at least one observation after baseline||Correlation Coefficient|||Number
770492|NCT00711516|Secondary|Activation-Performance Relationship Between Functional Magnetic Resonance Imaging (fMRI) in Posterior Parietal Cortex (PPC) and the 2-Back Working Memory Test -Number of Voxels Activated at Endpoint|With this outcome measure the correlation between the number of voxels activated on fMRI (voxels that differ significantly from reference wave form) in PPC versus performance on the 2-back working memory test was evaluated for both Armodafinil and Placebo. Correlation coefficients and P-values are presented for each treatment group.|Week 2 or Last Observation after Baseline|Full Analysis Set defined as subjects with at least one observation after baseline||Correlation Coefficient|||Number
770493|NCT00711516|Secondary|Activation-Performance Relationship Between the Functional Magnetic Resonance Imaging (fMRI) in Anterior Cingulate Cortex (ACC) and 2-Back Working Memory Test - Number of Voxels Activated at Endpoint|With this outcome measure the correlation between the number of voxels activated on fMRI (voxels that differ significantly from reference wave form) in ACC versus performance on the 2-back working memory test was evaluated for both Armodafinil and Placebo. Correlation coefficients and P-values are presented for each treatment group.|Week 2 or Last Observation after Baseline|Full Analysis Set defined as subjects with at least one efficacy evaluation after baseline||Correlation Coefficient|||Number
770494|NCT00711516|Secondary|Activation-Performance Relationship Between the Functional Magnetic Resonance Imaging (fMRI) in Dorsolateral Prefrontal Cortex (DLPFC) and 2-Back Working Memory Test - Number of Voxels Activated at Endpoint|With this outcome measure the correlation between the number of voxels activated on fMRI (voxels that differ significantly from reference wave form) in DLPFC versus performance on the 2-back working memory test was evaluated for both Armodafinil and Placebo. Correlation coefficients and P-values are presented for each treatment group.|Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects with at least one observation after baseline||Correlation Coefficient|||Number
770495|NCT00711516|Secondary|Blood Oxygenation Level Dependent (BOLD) Signal Intensity - Percent Change From Baseline to Endpoint in the Thalamus|Functional magnetic resonance imaging (fMRI) is a brain imaging technique that identifies neuronal activation in regions related to specific tasks or sensory stimulation such as language, vision, hearing, and short-term memory. When neuronal activity increases, blood flow increases to that part of the brain with an increase in the oxygen content of the blood. Increase in oxygen content causes the fMRI signal in that part of the brain to change, and is the basis of the BOLD effect. The percent change in BOLD signal from Baseline to 2 weeks or last observation after baseline is presented here.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy evaluation after baseline||Percent change in BOLD signal||Full Range|Median
770496|NCT00711516|Secondary|Blood Oxygenation Level Dependent (BOLD) Signal Intensity -Change From Baseline to Endpoint in the Posterior Parietal Cortex (PPC)|Functional magnetic resonance imaging (fMRI) is a brain imaging technique that identifies neuronal activation in regions related to specific tasks or sensory stimulation such as language, vision, hearing, and short-term memory. When neuronal activity increases, blood flow increases to that part of the brain with an increase in the oxygen content of the blood. Increase in oxygen content causes the fMRI signal in that part of the brain to change, and is the basis of the BOLD effect. The percent change in BOLD signal from Baseline to 2 weeks or last observation after baseline is presented here.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy evaluation after baseline||Percent change in Bold signal||Full Range|Median
770521|NCT00711529|Primary|Number of Daily Hot Flashes|"Patients kept daily diaries of their hot flashes. The absolute number of hot flashes in a 24 hour period is number of daily hot flashes. The median number was calculated for each week of data. The median number of daily hot flashes for the first week (7 days) of participation is used as baseline. The median number of daily hot flashes for the fourth week (over 7 day interval) is reported for the week four time point. The median number of daily hot flashes for the eighth week (over 7 day interval) is reported for the week eight time point (study completion). One woman in the hypnotherapy arm and 3 women in the gabapentin arm stopped keeping their diary before the 8 week mark."|Week 8|||daily hot flashes||Full Range|Median
770497|NCT00711516|Secondary|Blood Oxygenation Level Dependent (BOLD) Signal Intensity - Percent Change From Baseline to Endpoint in the Anterior Cingulate Cortex (ACC)|Functional magnetic resonance imaging (fMRI) is a brain imaging technique that identifies neuronal activation in regions related to specific tasks or sensory stimulation such as language, vision, hearing, and short-term memory. When neuronal activity increases, blood flow increases to that part of the brain with an increase in the oxygen content of the blood. Increase in oxygen content causes the fMRI signal in that part of the brain to change, and is the basis of the BOLD effect. The percent change in BOLD signal from Baseline to 2 weeks or last observation after baseline is presented here.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects with at least one efficacy evaluation after baseline||Percent change in BOLD signal||Full Range|Median
770498|NCT00711516|Secondary|Blood Oxygenation Level Dependent (BOLD) Signal Intensity - Percent Change From Baseline to Endpoint in the Dorsolateral Prefrontal Cortex (DLPFC)|Functional magnetic resonance imaging (fMRI) is a brain imaging technique that identifies neuronal activation in regions related to specific tasks or sensory stimulation such as language, vision, hearing, and short-term memory. When neuronal activity increases, blood flow increases to that part of the brain with an increase in the oxygen content of the blood. Increase in oxygen content causes the fMRI signal in that part of the brain to change, and is the basis of the BOLD effect. The percent change in BOLD signal from Baseline to 2 weeks or last observation after baseline is presented here.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy assessment after baseline.||Percentage change in BOLD signal||Full Range|Median
770499|NCT00711516|Secondary|Total Score From the Medical Outcomes Study 6-Item Cognitive Function Scale (MOS-CF6)-Change From Baseline to Endpoint|The MOS-CF6 is an instrument to assess patient self-reported cognitive function. Items were selected to cover 6 relevant aspects of cognitive functioning as follows: confusion, concentration/thinking, attention, memory, reasoning, problem solving, and processing speed. The CF 6 item responses include 6 choices, ranging from “none of the time” to “all of the time.” The CF-6 was scored by summing responses across the 6 items and converting the total to a 0 to 100 point scale, with higher scores indicating better cognitive functioning. Change in MOS-CF6 from baseline to endpoint is reported.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Population defined as subjects who had at least one efficacy evaluation after baseline.||Units on a scale||Standard Error|Least Squares Mean
770500|NCT00711516|Secondary|Clinical Global Impression of Change (CGI-C)- Number of Responders at Endpoint|Severity of sleepiness, was assessed by the Clinical Global Impression of Severity (CGI-S) at Baseline. The clinician assessed the change from baseline in the patient’s condition, as related to excessive sleepiness, in response to treatment using the CGI-C, which consisted of the following 7 categories and scoring assignments: very much improved, much improved, minimally improved, no change, minimally worse, much worse, and very much worse. Responders had to be at least minimally improved from Baseline to qualify as a responder at Endpoint.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy assessment after baseline||Participants|||Number
770501|NCT00711516|Secondary|Epworth Sleepiness Scale Change From Baseline to Endpoint|The patient’s evaluation of excessive daytime sleepiness was measured by the patient reported measure, ESS (Johns1991). The ESS score was based on responses to questions referring to 8 everyday situations (eg, sitting and reading, talking to someone, being stopped in traffic) and reflected a patient’s propensity to fall asleep in those situations. The ESS score was derived from the sum of the values from questions corresponding to the 8 situations. Scores for the ESS ranged from 0 to 24, with a higher score indicating a greater daytime sleepiness. Change from baseline to endpoint is presented.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full analysis set defined as subjects who had at least one efficacy evaluation after baseline||Units on a scale||Standard Error|Least Squares Mean
770502|NCT00711516|Secondary|One Touch Stockings of Cambridge (OTS) Mean Choices to Correct, (Hard) From the CANTAB Battery-Change From Baseline to Endpoint|OTS is a spatial planning test based on the Tower of London and the CANTAB Stockings of Cambridge test, and measures frontal lobe function. Patient shown 2 displays containing 3 colored balls and a row of boxes containing numbers. The patient was shown one demonstration problem and then solves 3 additional problems (easy). Problems increased in complexity, from one to six moves. With additional problems (hard) the patient had to work out how many moves the solutions required in their heads. Mean change from baseline to endpoint in number of choices to correct for hard problems is presented.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy assessment after baseline||Choices to correct||Standard Deviation|Mean
770503|NCT00711516|Secondary|One Touch Stockings of Cambridge (OTS) Mean Choices to Correct, (Easy) From the CANTAB Battery-Change From Baseline to Endpoint|OTS is a spatial planning test based on the Tower of London and the CANTAB Stockings of Cambridge test, and measures frontal lobe function. Patient shown 2 displays containing 3 colored balls and a row of boxes containing numbers. The patient is shown one demonstration problem and then solves 3 additional problems (easy). Problems increased in complexity, from one to six moves. With additional problems (hard) the patient has to work out how many moves the solutions required in their heads. Mean change from Baseline to endpoint in number of choices to correct for easy problems is presented.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy measure after baseline||Choices to correct||Standard Deviation|Mean
770504|NCT00711516|Secondary|One Touch Stockings of Cambridge (OTS) Mean Correct Latency, (Hard) From the CANTAB Battery-Change From Baseline to Endpoint|OTS is a spatial planning test based on Tower of London test and the CANTAB Stockings of Cambridge test, and measures frontal lobe function. Subject is shown 2 displays containing 3 colored balls and a row of boxes containing numbers. The patient was shown one demonstration problem and then had to solve 3 additional problems (easy). The problems increased in complexity, from one to six moves. With additional problems subject had to work out how many moves the solutions required in their heads (hard). Change from baseline to endpoint in Mean correct latency for the hard problems is presented.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy assessment after baseline||Milliseconds (ms)||Standard Deviation|Mean
771007|NCT00721188|Primary|Serum Terminal Phase Elimination Half-life (T1/2)||Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.|||hour||Standard Deviation|Mean
770505|NCT00711516|Secondary|One Touch Stockings of Cambridge (OTS) Mean Correct Latency, (Easy) From the CANTAB Battery-Change From Baseline to Endpoint|OTS is a spatial planning test based on Tower of London test and the CANTAB Stockings of Cambridge test, and measures frontal lobe function. Subject is shown 2 displays containing 3 colored balls and a row of boxes containing numbers. The patient was shown one demonstration problem and then had to solve 3 additional problems (easy). The problems increased in complexity, from one to six moves. With additional problems subject had to work out how many moves the solutions required in their heads (hard). Change from baseline to endpoint in Mean correct latency for the easy problems is presented.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy assessment after baseline.||Milliseconds (ms)||Standard Deviation|Mean
770506|NCT00711516|Secondary|Reaction Time Index (RTI) Median Correct Latency, One Choice Test From the CANTAB Battery-Change From Baseline to Endpoint|The RTI is a measure of simple and choice reaction time, movement time and spatio-temporal vigilance during simple and 5 choice reaction time trials. This task also permits measurement of anticipatory/premature responding and perseverative responding. The patient responded to a yellow spot appearing on the screen by letting go of the press pad and touching the location in which the spot appeared. The yellow spot appeared in a single location during the simple reaction time phase. The change from baseline to endpoint in median correct latency is presented here.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy assessment after baseline||Milliseconds (ms)||Full Range|Median
770507|NCT00711516|Secondary|Reaction Time Index (RTI) Median Correct Latency, Five Choice Test From the CANTAB Battery-Change From Baseline to Endpoint|The RTI is a measure of simple and choice reaction time, movement time and spatio-temporal vigilance during simple and 5 choice reaction time trials. This task also permits measurement of anticipatory/premature responding and perseverative responding. The patient responded to a yellow spot appearing on the screen by letting go of the press pad and touching the location in which the spot appeared. The yellow spot appeared in any 1 of 5 locations in the 5 choice reaction time phase. The change from baseline to endpoint in median correct latency is presented.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy assessment after baseline||Milliseconds (ms)||Full Range|Median
770508|NCT00711516|Secondary|Pattern Recognition Memory (PRM) Percent Correct (Delayed) From the CANTAB Battery-Change From Baseline to Endpoint|"The PRM test from the Cambridge Neuropsychological Test Automated Battery (CANTAB) assesses episodic memory as measured by a patient’s ability to encode and recognize visual information. Patterns appear sequentially on the screen, and patients are instructed to remember them. Twenty minutes following the immediate recognition test, another delayed recognition test is performed, featuring the same stimuli as in the first phase. The change from baseline to endpoint in percent correct responses of this delayed test are presented here. Subjects complete 24 trials per assessment."|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy evaluation after baseline||Percent correct trials|Participants|Standard Deviation|Mean
770509|NCT00711516|Secondary|Pattern Recognition Memory (PRM) Percent Correct (Immediate) From the CANTAB Battery-Change From Baseline to Endpoint|The PRM test from the Cambridge Neuropsychological Test Automated Battery (CANTAB) assesses episodic memory by a patient’s ability to encode and recognize visual information. Patterns appear sequentially on the screen, and patients are instructed to remember them. Immediately afterwards a recognition test is performed, in which each pattern shown earlier is presented with another pattern of similar form and color. Patient has to touch the pattern seen earlier. Change from baseline to endpoint in % correct responses with immediate recall is presented. Subjects complete 24 trials per assessment.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy evaluation after baseline||Percent correct trials|Participants|Standard Deviation|Mean
770510|NCT00711516|Secondary|Change From Baseline to Endpoint in the Number of Contiguous Activated Voxels Meeting the Predefined Threshold in the Thalamus|The outcome was the change from baseline in number of contiguous activated voxels in the thalamus on functional magnetic resonance imaging (fMRI) at Week 2(or last observation after baseline). Each voxel is compared to the reference wave form. If it differs from that value significantly (p<0.05), the voxel is considered active. fMRI is a brain imaging technique that identifies neuronal activation related to specific tasks or sensory stimulation. Increased neuronal activity increases blood flow and oxygen content to the activated part of the brain, altering fMRI signal.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set||Activated voxels||Standard Error|Mean
770511|NCT00711516|Secondary|Change From Baseline to Endpoint in the Number of Contiguous Voxels Meeting the Predefined Threshold in the Posterior Parietal Cortex (PPC)|The outcome was the change from baseline in number of contiguous activated voxels in the posterior parietal cortex (PPC) on functional magnetic resonance imaging (fMRI) at Week 2(or last observation after baseline). Each voxel is compared to the reference wave form. If it differs from that value with p<0.05, the voxel is considered active. fMRI is a brain imaging technique that identifies neuronal activation related to specific tasks or sensory stimulation. Increased neuronal activity increases blood flow and oxygen content to the activated part of the brain, altering fMRI signal.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy assessment after baseline||Activated voxels||Standard Deviation|Mean
770512|NCT00711516|Secondary|Change From Baseline to Endpoint in the Number of Contiguous Activated Voxels Meeting the Predefined Threshold in the Anterior Cingulate Cortex (ACC)|The outcome was the change from baseline in number of contiguous activated voxels in the anterior cingulate cortex (ACC) on functional magnetic resonance imaging (fMRI) at Week 2(or last observation after baseline). Each voxel is compared to the reference wave form. If it differs from that value p<0.05, the voxel is considered active. fMRI is a brain imaging technique that identifies neuronal activation related to specific tasks or sensory stimulation. Increased neuronal activity increases blood flow and oxygen content to the activated part of the brain, altering fMRI signal.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy assessment after baseline||Activated Voxels||Standard Deviation|Mean
771008|NCT00721188|Primary|Time to Maximum Serum Concentration (Tmax)||Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.|||hour||Standard Deviation|Mean
770513|NCT00711516|Secondary|Change From Baseline to Endpoint in Mean Response Latency in the 2-Back Working Memory Test at Endpoint - Mean Performance Speed|The 2-Back is a verbal working memory test in which random letters are presented visually every 4 sec, with each stimulus lasting 500 msec. Subjects are asked to make a yes/no response following each letter indicating whether it was the same or different from the letter presented two earlier. The load on working memory was the ordering, retention, updating, and manipulation of 2 letters and consideration of the relationship to a 3rd newly presented letter, which could have been a target or a nontarget. The change from baseline in response latency at endpoint is presented here.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy assessment after baseline.||Milliseconds (ms)||Standard Deviation|Mean
770514|NCT00711516|Primary|Change From Baseline to Endpoint in Number of Contiguous Activated Voxels Meeting Predefined Threshold in Dorsolateral Prefrontal Cortex (DLPFC) on Functional Magnetic Resonance Imaging (fMRI) as a Measure of Prefrontal Cortical Activation|The primary outcome was the change from baseline in number of contiguous activated voxels in the dorsolateral prefrontal cortex (DLPFC) on functional magnetic resonance imaging (fMRI) at Week 2(or last observation after baseline). Each voxel is compared to the reference wave form. If it differs from that value p<0.05, the voxel is considered active. fMRI is a brain imaging technique that identifies neuronal activation related to specific tasks or sensory stimulation. Increased neuronal activity increases blood flow and oxygen content to the activated part of the brain, altering fMRI signal.|Baseline and Endpoint (Week 2 or last observation after baseline)|Efficacy analyses were performed on the full analysis dataset which includes those patients in the safety analysis set who had at least 1 post baseline primary efficacy assessment.||Activated voxels||Standard Deviation|Mean
770515|NCT00711529|Secondary|Hot Flash Related Daily Interference Score (HFRDIS)|The HFRDIS is a validated survey of 10 questions asking patients to rate ten hot flash-related symptoms on a scale of 0-10. The HFRDIS is a sum of the scores in each category, so that total score can range from 0 (no symptoms) to 100 (10 severe symptoms). These surveys were conducted at the time of enrollment (baseline), after four weeks of treatment, and at the conclusion of the study (8 weeks). All nine women who initiated hypnotherapy treatment completed the survey at the end of 8 weeks. One woman in the gabapentin arm did not submit a survey at 8 weeks.|Week 8|||units on a scale (HFRDIS)||Full Range|Median
770516|NCT00711529|Secondary|Hot Flash Related Daily Interference Score (HFRDIS)|The HFRDIS is a validated survey of 10 questions asking patients to rate ten hot flash-related symptoms on a scale of 0-10. The HFRDIS is a sum of the scores in each category, so that total score can range from 0 (no symptoms) to 100 (10 severe symptoms). These surveys were conducted at the time of enrollment (baseline), after four weeks of treatment, and at the conclusion of the study (8 weeks). Of 11 eligible women in the hypnotherapy arm, 2 never initiated treatment, and 3 did not complete the survey at this time point. Of the 14 eligible women in the gabapentin arm, 3 never initiated treatment, and 3 dropped out of the study before the 4 week time point.|Week 4|||units on a scale (HFRDIS)||Full Range|Median
770517|NCT00711529|Secondary|Hot Flash Related Daily Interference Score (HFRDIS)|The HFRDIS is a validated survey of 10 questions asking patients to rate ten symptoms on a scale of 0-10. The HFRDIS is a sum of the scores in each category, so that total score can range from 0 (no symptoms) to 100 (10 severe symptoms). These surveys were conducted at the time of enrollment (baseline), after four weeks of treatment, and at the conclusion of the study (8 weeks). All women who were randomized were included in the baseline analysis (with the exception of 2 women excluded from the hypnotherapy arm who were deemed ineligible after randomization).|Baseline|||units on a scale (HFRDIS)||Full Range|Median
770518|NCT00711529|Primary|Hot Flash Severity Score|The patients kept daily hot flash diaries, including the total number of hot flashes they characterized as mild, moderate,severe and very severe. Hot flash severity scores were calculated by assigning one point to each mild hot flash, two points for each moderate hot flash, three points for each severe hot flash and four points for each very severe hot flash. The hot flash severity score for a 24 hour period was the sum of these scores. The score was calculated for each day in the diary. For each subject, median scores were calculated for each week (7 day period) of participation. The median hot flash severity score for the first week was considered the baseline. The median hot flash severity score for the fourth week is considered the week 4 time point. The median hot flash severity score for the eighth week is considered the week 8 time point. The median result for the group was then calculated at each of the timepoints.|Week 8|||units on a scale (severity score)||Full Range|Median
770519|NCT00711529|Primary|Hot Flash Severity Score|The patients kept daily hot flash diaries, including the total number of hot flashes they characterized as mild, moderate,severe and very severe. Hot flash severity scores were calculated by assigning one point to each mild hot flash, two points for each moderate hot flash, three points for each severe hot flash and four points for each very severe hot flash. The hot flash severity score for a 24 hour period was the sum of these scores. The score was calculated for each day in the diary. For each subject, median scores were calculated for each week (7 day period) of participation. The median hot flash severity score for the first week was considered the baseline. The median hot flash severity score for the fourth week is considered the week 4 time point. The median hot flash severity score for the eighth week is considered the week 8 time point. The median result for the group was then calculated at each of the timepoints.|Week 4|||units on a scale (severity score)||Full Range|Median
770520|NCT00711529|Primary|Hot Flash Severity Score|The patients kept daily hot flash diaries, including the total number of hot flashes they characterized as mild, moderate,severe and very severe. Hot flash severity scores were calculated by assigning one point to each mild hot flash, two points for each moderate hot flash, three points for each severe hot flash and four points for each very severe hot flash. The hot flash severity score for a 24 hour period was the sum of these scores. The score was calculated for each day in the diary. For each subject, median scores were calculated for each week (7 day period) of participation. The median hot flash severity score for the first week was considered the baseline. The median hot flash severity score for the fourth week is considered the week 4 time point. The median hot flash severity score for the eighth week is considered the week 8 time point. The median result for the group was then calculated at each of the timepoints.|Baseline|||units on a scale (severity score)||Full Range|Median
770579|NCT00711958|Primary|Efficacy of HX575 in the Treatment of Chemotherapy Associated Anemia|Proportion of patients with a change in hemoglobin levels more than 2 g/dL under treatment with HX575, estimated between weeks 5-12.|5-12 weeks|Intention-to-treat population: patients with post baseline Hemoglobin value available||Participants|||Count of Participants
770522|NCT00711529|Primary|Number of Daily Hot Flashes|"Patients kept daily diaries of their hot flashes. The absolute number of hot flashes in a 24 hour period is number of daily hot flashes. The median number was calculated for each week of data. The median number of daily hot flashes for the first week (7 days) of participation is used as baseline. The median number of daily hot flashes for the fourth week (over 7 day interval) is reported for the week four time point. The median number of daily hot flashes for the eighth week (over 7 day interval) is reported for the week eight time point (study completion). A total of 15 diaries were submitted (7 hypnotherapy, 8 gabapentin). One person in each arm stopped recording in her diary before the 4 week mark."|Week 4|||daily hot flashes||Full Range|Median
770523|NCT00711529|Primary|Number of Daily Hot Flashes|"Patients kept daily diaries of their hot flashes. The absolute number of hot flashes in a 24 hour period is number of daily hot flashes. The median number was calculated for each week of data. The median number of daily hot flashes for the first week (7 days) of participation is used as baseline. The median number of daily hot flashes for the fourth week (over 7 day interval) is reported for the week four time point. The median number of daily hot flashes for the eighth week (over 7 day interval) is reported for the week eight time point (study completion). Of the 13 women randomized to the hypnotherapy arm, 2 women were ineligible and therefore not included in analysis. Two women were unable to initiate treatment and did not submit diaries. An additional two women completed treatment but lost their diaries, leaving 7 diaries for analysis at baseline. Of the 14 randomized to receive gabapentin, 6 dropped out of the study and did not submit diaries."|Baseline|||daily hot flashes||Full Range|Median
770524|NCT00711555|Secondary|no Significant Nausea|defined as a maximum nausea severity < 25 mm (100 mm visual analog scale, 0 = no nausea, 100 = worst nausea)|cycle 1, day 1|||%|||Number
770525|NCT00711555|Secondary|no Nausea|defined as maximum nausea severity < 5 mm (100 mm visual analog scale, 0 = no nausea, 100 = worst nausea)|cycle 1, day 1|||%|||Number
770526|NCT00711555|Secondary|no Emesis||cycle 1, day 1|||%|||Number
770527|NCT00711555|Secondary|Complete Protection|defined as no emesis, no use of rescue medications, and a maximum nausea severity < 25 mm (100 mm visual analog scale, 0 = no nausea, 100 = worst nausea)|cycle 1, day 1|||%|||Number
770528|NCT00711555|Primary|Complete Response|defined as a no emetic episodes and no use of rescue therapy|cycle 1, day 1|||%|||Number
770529|NCT00711594|Secondary|Phase I Step: Cmax,Cmax,ss of BIBW 2992 After Multiple Oral Administration||Just before start of the treatment to Course 4 Visit 4R2|"The “treated set” of patients was defined as all patients who received at least 1 dose of BIBW 2992 medication.Some samples were excluded from the evaluation because these were taken outside the allowed time-windows.
Number of analyzed patients of BIBW 50mg cohort for Cmax,ss: 5"||ng/mL||Geometric Coefficient of Variation|Geometric Mean
770530|NCT00711594|Secondary|Phase II Step: Summary of EGFR Mutation Findings||Screening visit|"The treated set of patients was defined as all patients who received at least 1 dose of BIBW 2992 medication."||participants|||Number
770531|NCT00711594|Secondary|Phase II Step: Trough Plasma Concentrations of BIBW2992 After Multiple Oral Administration of BIBW 2992: Treatment course2 Day 15|Outcome data show the gMean of trough plasma concentrations of BIBW 2992 after multiple oral administration of BIBW|Course 2 Day 15|"Plasma concentrations of BIBW2992 were to be presented for all patients and sampling points with concentrations above the lower limit of quantification.
The dose determined from the result of the Phase I step (50 mg) will be used. Reduction of dose in accordance to the criteria specified by adverse events to 40 mg or 30 mg was possible."||ng/ml||Geometric Coefficient of Variation|Geometric Mean
770532|NCT00711594|Secondary|Phase II Step: Trough Plasma Concentrations of BIBW2992 After Multiple Oral Administration of BIBW 2992: Treatment course2 Day 1|Outcome data show the gMean of trough plasma concentrations of BIBW 2992 after multiple oral administration of BIBW|Course 2 Day 1|"Plasma concentrations of BIBW2992 were to be presented for all patients and sampling points with concentrations above the lower limit of quantification.
The dose determined from the result of the Phase I step (50 mg) will be used. Reduction of dose in accordance to the criteria specified by adverse events to 40 mg or 30 mg was possible."||ng/ml||Geometric Coefficient of Variation|Geometric Mean
770533|NCT00711594|Secondary|Phase II Step: Trough Plasma Concentrations of BIBW2992 After Multiple Oral Administration of BIBW 2992: Treatment course1 Day 15|"Outcome data show the geometric mean (gMean) of trough plasma concentrations of BIBW 2992 after multiple oral administration of BIBW.
The dose determined from the result of the Phase I step (50 mg) will be used. Reduction of dose in accordance to the criteria specified by adverse events to 40 mg or 30 mg was possible."|Course 1 Day 15|Plasma concentrations of BIBW2992 were to be presented for all patients and sampling points with concentrations above the lower limit of quantification. No patient was treated with 30 mg during the Course 1.||ng/ml||Geometric Coefficient of Variation|Geometric Mean
770534|NCT00711594|Secondary|Phase II Step: Maximum CTC Grade During the Trial for Laboratory Parameters, Among Patients Who Experienced an Increase in CTC Grade From Baseline|outcome data show the number of patients for the maximum CTC grade during the trial for laboratory parameters, among patients who experienced an increase in CTC Grade|Start of treatment to end of treatment (up to 41.3 months) plus 4 week follow-up|"The treated set of patients was defined as all patients who received at least 1 dose of BIBW 2992 medication.
For activated partial thromboplastin time (APTT), N = 59 For Prothrombin Time and International Normalized Ratio (PT-INR), N = 61"||participants|||Number
770535|NCT00711594|Secondary|Phase II Step: Safety of BIBW 2992 as Indicated by Intensity and Incidence of Adverse Events, Graded According to CTCAE|outcome data show the number of patients with Adverse events (AE) by intensity and incidence of adverse events, graded according to CTCAE.|Start of treatment to end of treatment (up to 41.3 months) plus 4 week follow-up|"The treated set of patients was defined as all patients who received at least 1 dose of BIBW 2992 medication."||participants|||Number
770536|NCT00711594|Secondary|Phase II Step: Overall Survival (OS)|OS was defined as the duration of time from the start of treatment to the time of death.|from start of treatment until end of follow up, up to 53 months|The “full analysis set” of patients was defined as all patients includes in the treated set who have both baseline tumour imaging data and at least one analysable tumour imaging data after BIBW 2992 started.||Months||Inter-Quartile Range|Median
770580|NCT00711971|Other Pre-specified|Cord Arterial pH|Arterial blood gas analysis of umbilical cord blood|Immediately after birth (collected within the first hour after delivery)|Umbilical cord gases (pH) were sent at the discretion of the delivering physician and so were not available for all participants.||pH||Standard Deviation|Mean
770537|NCT00711594|Secondary|Phase II Step: Progression-free Survival (PFS)|PFS was defined as the duration of time from the start of treatment until the day of objective tumour progression confirmed by tumour imaging (PD according to the RECIST) or death.|Tumour Assessment were performed at screening 14 days (prior to enrollment), in week 4, week 8, week 12 and in 8-week intervals thereafter, and at the end of trial visit (patients discontinuation) up to 41.3 months|The “full analysis set” of patients was defined as all patients includes in the treated set who have both baseline tumour imaging data and at least one analysable tumour imaging data after BIBW 2992 started.||Months||Inter-Quartile Range|Median
770538|NCT00711594|Secondary|Phase II Step: Duration of Clinical Benefit|Presented as duration of disease control.|Tumour Assessment were performed at screening 14 days (prior to enrollment), in week 4, week 8, week 12 and in 8-week intervals thereafter, and at the end of trial visit (patients discontinuation) up to 41.3 months|The “full analysis set” of patients was defined as all patients includes in the treated set who have both baseline tumour imaging data and at least one analysable tumour imaging data after BIBW 2992 started.||Weeks||Full Range|Median
770539|NCT00711594|Secondary|Phase I Step: Summary of Epidermal Growth Factor Receptor (EGFR) Mutation Findings||Screening visit|"The treated set of patients was defined as all patients who received at least 1 dose of BIBW 2992 medication."||participants|||Number
770540|NCT00711594|Secondary|Phase II Step: Duration of Objective Response|Duration of objective response was defined as the time at which RECIST was first met for CR or PR (whichever was first recorded) until the first date that recurrent or progressive disease (PD) was objectively documented.|Tumour Assessment were performed at screening 14 days (prior to enrollment), in week 4, week 8, week 12 and in 8-week intervals thereafter, and at the end of trial visit (patients discontinuation) up to 41.3 months|The “full analysis set” of patients was defined as all patients includes in the treated set who have both baseline tumour imaging data and at least one analysable tumour imaging data after BIBW 2992 started.||weeks||Full Range|Median
770541|NCT00711594|Secondary|Phase II Step: Time to Objective Response|Number of participants with first response at week 4, 8 and 12, assessed by investigator and independent review.|Tumour Assessment were performed at screening 14 days (prior to enrollment), in week 4, week 8, week 12 and in 8-week intervals thereafter, and at the end of trial visit (patients discontinuation) up to 41.3 months|"The full analysis set of patients was defined as all patients includes in the treated set who have both baseline tumour imaging data and at least one analysable tumour imaging data after BIBW 2992 started."||Number of patients|||Number
770542|NCT00711594|Secondary|Phase II Step: Clinical Benefit|Clinical benefit was defined as a RECIST assessment of complete response, partial response, or stable disease according to the best response to study treatment as defined in the previous section. Clinical benefit presented as the disease control.|Tumour Assessment were performed at screening 14 days (prior to enrollment), in week 4, week 8, week 12 and in 8-week intervals thereafter, and at the end of trial visit (patients discontinuation) up to 41.3 months|"The full analysis set of patients was defined as all patients includes in the treated set who have both baseline tumour imaging data and at least one analysable tumour imaging data after BIBW 2992 started."||percentage of participants||95% Confidence Interval|Number
770543|NCT00711594|Secondary|Phase I Step: AUC0-24, AUCtau,ss of BIBW 2992 After Multiple Oral Administration|area under the concentration-time curve of BIBW 2992 over the time interval 0-24 hours (AUC0-24), Area under the concentration-time curve of Afatinib in plasma at steady state (AUCtau,ss) after multiple oral administration Pharmacokinetic was abbreviated to PK.|AUC0-24: just before drug administration, 0:30,1:00, 2:00, 3:00, 4:00, 5:00, 7:00, 9:00, 24:00 on Day 1-2 in Course 1; AUCtau,ss: just before drug administration, 0:30,1:00, 2:00, 3:00, 4:00, 5:00, 7:00, 9:00, 24:00, 48:00, 72:00 on Day 28-31 in Course 1|"“Treated set” was defined as all patients who received at least 1 dose of BIBW2992. Some samples were excluded from calculation of descriptive statistics of plasma concentration because these were taken outside the allowed time-windows but used for calculation of PK parameters.
Number of analyzed patients of BIBW 50mg:5(AUCtau,ss), 40mg:2(AUC0-24)"||ng·h/mL||Geometric Coefficient of Variation|Geometric Mean
770544|NCT00711594|Primary|Phase II Step: Objective Tumour Response According to Response Evaluation Criteria in Solid Tumours (RECIST)|The objective response (complete response [CR] and partial response [PR]) was defined as determined by the RECIST according to the best response to study treatment.|Tumour Assessment were performed at screening 14 days (prior to enrollment), in week 4, week 8, week 12 and in 8-week intervals thereafter, and at the end of trial visit (patients discontinuation), up to 41.3 months|"The full analysis set of patients was defined as all patients included in the treated set who have both baseline tumour imaging data and at least one analysable tumour imaging data after BIBW 2992 started."||percentage of participants||95% Confidence Interval|Number
770545|NCT00711594|Primary|Phase I Step: Safety of BIBW 2992 Assessed Based on Incidence of Dose Limiting Toxicity (DLT) and Incidence & Intensity of Adverse Events According to CTCAE||start of treatment to end of treatment|"The treated set of patients was defined as all patients who received at least 1 dose of BIBW 2992 medication."||participants|||Number
770546|NCT00711646|Secondary|Change From Baseline in Mean Motricity Index Score for the Legs|Ankle dorsiflexion, knee extension and hip flexion were assessed and scored to give a maximum of 100%. The Motricity Index score (scale 1-100) was recorded for limbs that had an associated Ashworth Scale score, which was greater than or equal to two at baseline.|Day 7 and Day 52|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.||units on a scale||Standard Deviation|Mean
770547|NCT00711646|Secondary|Incidence of Adverse Events as a Measure of Subject Safety|The number of subjects who reported an adverse event during the course of the study is presented.|Day 0-52|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.||participants|||Number
770548|NCT00711646|Secondary|Patient’s Global Impression of Change in Condition at the End of Treatment|A 7-point Likert-type scale was used, with the question: ‘Please assess the change in your condition since entry into the study using the scale below’ with the markers “very much improved, much improved, slightly improved, no change, slightly worse, much worse or very much worse”. At Visit 2 (Baseline) patients wrote a brief description of their condition which was used at end of treatment to aid their memory regarding their symptoms at study start. For each of above markers the number of participants were reported.|Day 52|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.||participants|||Number
770549|NCT00711646|Secondary|Change From Baseline in Mean Motricity Index Score for the Arms|Arm - 3 movements were pinch grip, elbow flexion and shoulder abduction. The total arm score was the addition of the score for the 3 arm movements. One point was then added to give a maximum score of 100; minimum was 1 point. Where both arms were assessed, the average of the two limbs scores was used as the assessment score; otherwise the affected limb total score was used. An increase in score indicates an improvement in condition..|Day 7 and 52|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.||units on a scale||Standard Deviation|Mean
770550|NCT00711646|Secondary|Change From Baseline in Mean Spasm Frequency Score at the End of Treatment|Each day subjects recorded in their diary the frequency of their spasms using the following scoring system: 0 = no spasms, 1 = one or fewer spasms per day, 2 = between one and five spasms per day, 3 = six to nine spasms per day, 4 = ten or more spasms per day or continuous contraction. For the analysis, end of treatment was defined as the mean of the last seven days in the study or the last three days if the subject withdrew due to worsening spasticity or lack of efficacy.|Days 0 - 52|||units on a scale||Standard Deviation|Mean
770551|NCT00711646|Secondary|Change From Baseline in Mean Ashworth Scale Score at the End of Treatment|The mean Ashworth Scale score across muscle groups was calculated using only those muscle groups with a score of greater than or equal to two at baseline. All 20 muscle groups were assessed for spasticity (using a 1-5 scale): 1= no increase in muscle tone to 5= passive movement is difficult and affected part is rigid in flexion or extension. The score for all 20 muscle groups were added to give a total score out of 100; minimum score was 20. A decrease in score indicates an improvement in condition.|Days 0 - 52|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.||units on a scale||Standard Deviation|Mean
770552|NCT00711646|Primary|Assessment of Change From Baseline in the Mean Spasticity 0-10 Numerical Rating Scale Score.|"The spasticity Numerical Rating Scale was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate the number that best describes your average spasticity in the last 24 hours where 0 = no spasticity and 10 = worst ever spasticity. For the analysis, end of treatment was defined as the mean of the last seven days in the study or the last three days if the subject withdrew due to worsening spasticity or lack of efficacy. A negative value indicates an improvement in spasticity score from baseline."|0-52 days|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.||units on a scale||Standard Deviation|Mean
770553|NCT00711802|Secondary|Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve for Daptomycin From 0 to the Last Sampling Time Point (AUC[0-t])|"Participants who volunteered for PK sampling had a blood sample collected for analysis at the following time points:
Age Group 1; Day 3: Predose, 0.25 hour (hr), 1 hr, 4 hr, and12 hr postdose. Age Group 2; Day 3: Predose, 0.25 hr, 1 hr, 6 hr, and 10 hr postdose. Age Group 3; Day 1, 2, or 3: Predose, 0.25 hr, 1 hr, 6 hr, and 8 hr postdose. Age Group 4; Day 1, 2, or 3: 0, 1, 2, 4, and 6 hr relative to end of infusion."|Predose and 5 timepoints according to age group (up to 12 hours postdose)|Participants who received at least 1 dose of study drug with evaluable daptomycin AUC(0-t) data.||microgram*hour per milliliter (μg*hr/mL)||Standard Deviation|Mean
770554|NCT00711802|Secondary|Percentage of Participants With an Overall Therapeutic Response at Test of Cure Visit|"The assessment of therapeutic response was determined by comparing a participant's signs and symptoms at the test of cure visit (up to 14 days after last dose) to those recorded at baseline. Participants were classified as Success or Failure by combining their clinical and microbiological efficacy responses. Resolution of clinically significant signs and symptoms associated with the skin infection present at study baseline was considered Success by the Investigator. These participants were deemed both clinically cured and microbiologically eradicated. For participants whose clinical course could not be clearly defined as improved, a clinical outcome of “Failure” was rendered. In addition, if it was determined that the primary site of infection required additional antibiotic treatment, the assessment of clinical response was “Failure.” If the Investigator was unable to determine a response because the participant was lost to follow-up, the assessment was Unable to evaluate."|Baseline through 14 days after last dose of study drug|Participants who received at least 1 dose of study drug with evaluable test-of-cure visit data.||percentage of participants|||Number
770555|NCT00711802|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)|"A TEAE was defined as any treatment-emergent adverse event (AE) that occurred from the time of first dose of the study drug through the last study evaluation or pre-existing adverse AEs that were aggravated in severity or frequency during the dosing period. The percentage of participants with at least 1 TEAE, with at least one drug-related AE (drug-related included possibly related or related as deemed by the Investigator; it also included events if causality was missing), and who discontinued from treatment due to a TEAE is presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module."|Baseline through 14 days after last dose of study drug|Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data.||percentage of participants|||Number
770556|NCT00711828|Secondary|Adverse Events|Adverse events were assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 after each cycle of treatment. The maximum grade for each type of adverse event were recorded for each patient, and frequency tables were reviewed to determine patterns. For this endpoint, the number of patients receiving a Grade 3, Grade 4, or Grade 5 as their highest reported grade regardless of attribution are reported. A full list of adverse events are reported in the Adverse Events section of this report.|up to 12 cycles (28 days per cycle) of treatment|||participants|||Number
770557|NCT00711828|Secondary|Time to Treatment Failure|Time to treatment failure is defined to be the time from registration to the date at which the patient is removed from treatment due to progression, adverse events, or refusal. If the patient is considered to be a major treatment violation or is taken off study as a non-protocol failure, the patient will be censored on the date they are removed from treatment. The distribution of time to treatment failure will be estimated using the method of Kaplan-Meier.|Up to 3 years from registration|||months||95% Confidence Interval|Median
770892|NCT00720499|Secondary|12-lead ECG QT Intervals|"12-lead ECG QT intervals baseline and change from baseline at other time points in milliseconds.
Statistics for each planned time from baseline to day 29."|Baseline, then 10min, 1h after drug administration on day 1, 30min before and 10min after drug administration on day 15, in addition 1h after drug administration on day 29|TS||mS||Standard Deviation|Mean
770558|NCT00711828|Secondary|Duration of Response|Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient’s earliest objective status is first noted to be either a CR or PR to the earliest date progression is documented. MR for Waldenstrom lymphoma will not be included as a response. Median duration of response and the confidence interval for the median duration will be computed.|Up to 3 years from registration|Thirteen patients achieved a CR or a PR and are included in this analysis.||months||95% Confidence Interval|Median
770559|NCT00711828|Secondary|Progression-free Survival|Progression-free survival time is defined as the time from registration to the earliest date of documentation of disease progression or death, whichever occurs first. Progression is defines as having any new lesion or increase by 50% of previously involved sites from nadir. The distribution of progression-free survival time will be estimated using the method of Kaplan-Meier.|Up to 3 years from registration|||months||95% Confidence Interval|Median
770560|NCT00711828|Secondary|Overall Survival|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.|Up to 3 years from registration|||months||95% Confidence Interval|Median
770561|NCT00711828|Primary|Proportion of Responses (Complete Response or Partial Response)|A response is defined to be a Complete Response (CR) or Partial Response (PR) noted as the objective status on any evaluation (i.e., best response). The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. A confidence interval for the true success proportion will be calculated according to the properties of the binomial distribution.|up to 12 cycles|||percentage of participants||95% Confidence Interval|Number
770562|NCT00711867|Primary|Sublingual Temperature.||Within 10 minutes of arrival in PACU|Per protocol.||C||Standard Deviation|Mean
770563|NCT00711880|Secondary|Incidence of Adverse Events as a Measure of Subject Safety|The number of subjects who reported an adverse event during the course of the study is presented|Day 0 - Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis||participants|||Number
770564|NCT00711880|Secondary|Subject Global Impression of Change in the Severity of Allodynia in Their Chosen Allodynic Area at the End of Treatment|"Subjects were asked to give their impression of the overall change in their allodynia since entry into the study using the following seven-point scale: 1 = ‘Very Much Improved’, 2 = ‘Much Improved’, 3 = ‘Minimally Improved’, 4 = ‘No Change’, 5 = ‘Minimally Worse’, 6 = ‘Much Worse’, 7 = ‘Very Much Worse’.
A summary of the number and percentage of subjects"|Day 0 - 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis||participants|||Number
770565|NCT00711880|Secondary|Change From Pre-dose in Mean Intoxication 100 mm Visual Analogue Scale Score at the End of Treatment|Intoxication scores were measured using a 100 mm Visual Analogue Scale, where 0 equalled ‘no intoxication’ and 100 equalled ‘extreme intoxication’. A negative value indicates an improvement in intoxication score from baseline.|Day 0 - Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis||units on a scale||Standard Deviation|Mean
770566|NCT00711880|Secondary|Subject Global Impression of Change in the Severity of Peripheral Neuropathic Pain at the End of Treatment|Subjects were asked to give their impression of the overall change in their peripheral neuropathic pain since entry into the study using the following seven-point scale: 1 = ‘Very Much Improved’, 2 = ‘Much Improved’, 3 = ‘Minimally Improved’, 4 = ‘No Change’, 5 = ‘Minimally Worse’, 6 = ‘Much Worse’, 7 = ‘Very Much Worse’. The number of subjects who reported an improvement is presented.|Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis||participants|||Number
770567|NCT00711880|Secondary|Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for 'Word List Generation' at the End of Treatment|Word list generation measures verbal associative fluency. Patients are given 60 seconds to give as many words beginning with a particular letter. The Total is the unweighted sum of all admissible words over three different trials. Higher scores indicate a better cognitive performance (min=0, max= not defined).|Day 7 and Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis||number of words||Standard Deviation|Mean
770568|NCT00711880|Secondary|Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for 'Paced Auditory Serial Addition Task' at the End of Treatment|The Paced Auditory Serial Addition Task assesses sustained attention and concentration. A pre-recorded tape is used to present two series of 60 numbers, one every 3 seconds and one every 2 seconds. Patients are asked to add each number to the one immediately preceding it and give the result. The task summary score is the percentage of correct answers is calculated. The PASAT score range was 0% to 100%. Higher scores indicate a better cognitive|Day 7 and Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis||percentage of correct answers||Standard Deviation|Mean
770569|NCT00711880|Secondary|Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for 'Symbol Digit Modalities' at the End of Treatment|The Symbol Digit Modalities Test measures complex attention and concentration in a task which also requires speed and accuracy in visual search and scanning. Patients are required to associate symbols with numbers and quickly generate the number when shown the symbol. The summary endpoint is the number of correct responses in 90 seconds. The symbol digit modalities test had a min of 0 and max score of 99. A higher score indicates better cognitive performance.|Day 7 and Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis||units on a scale||Standard Deviation|Mean
770581|NCT00711971|Other Pre-specified|Five Minute Apgar Score|Apgar scores are based on a scale of 0 - 10 where 0 is a dead baby and 10 is an optimally vigorous newborn. The Apgar score analyzed here is the five minute Apgar.|5 minutes after birth|One set of twins from EPA group; Soy oil arm has data for only 40 as one baby was born elsewhere so Apgar data is not available.||units on a scale||Standard Deviation|Mean
770582|NCT00711971|Other Pre-specified|One Minute Apgar Score|Apgar scores are based on a scale of 0 - 10 where 0 is a dead baby and 10 is an optimally vigorous newborn. The Apgar score analyzed here is the one minute Apgar.|1 minute after birth|One set of twins from EPA group; Soy oil arm has data for only 40 as one baby was born elsewhere so Apgar data is not available.||units on a scale||Standard Deviation|Mean
770570|NCT00711880|Secondary|Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for ‘10/36 Spatial Recall' at the End of Treatment|The 10/36 Spatial Recall Test assesses visual spatial learning and delayed recall. Patients are asked to view a 6 x 6 checkerboard with ten checkers for 10 seconds. They are then asked to recreate the pattern viewed on a blank checkerboard. The number of correct responses from three immediate trials and one delayed trial (7 minute delay) are recorded. The Total number of correct responses is the unweighted sum from the four trials. The score for the 10/36 spatial recall test was the unweighted average of four individual study results (min=0 and max=40). A higher score indicates better cognitive performance.|Day 7 and Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis||units on a scale||Standard Deviation|Mean
770571|NCT00711880|Secondary|Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for 'Selective Reminding' at the End of Treatment|The Selective Reminding Test measures verbal learning and delayed recall through a multiple-trial list-learning paradigm. Patients are presented aurally with a list of 12 words for trial 1 and are asked to recall as many as possible. For trials 2-6, there is a selective presentation of only those words not recalled on the previous trial. Trial 7 is similar to the other trials but is assessed after an 11-minute delay. The score for the selective reminding test is the unweighted average of seven individual study results (min=0 and max=84) Higher scores indicate a better cognitive performance.|Day 7 and Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis||units on a scale||Standard Deviation|Mean
770572|NCT00711880|Secondary|Change From Baseline in Mean Total General Health Questionnaire Score at the End of Treatment|The General Health Questionnaire-12 is designed to measure non-psychotic mental disorders. It consists of 12 questions, scored on a 0 to 3 Likert scale to measure and compare psychological morbidity levels, where 0 represents better psychological health. The total General Health Questionnaire-12 score is the unweighted sum of the 12 scores. Zero indicates the best possible psychological health, 36 indicates the worst possible psychological health.|Day 7 and Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis||units on a scale||Standard Deviation|Mean
770573|NCT00711880|Secondary|Change From Baseline in Mean Static Allodynia Test Score at the End of Treatment|The static allodynia test involved applying pressure to a non-allodynic area (on the contralateral side to the identified allodynic area), and recording the pressure that caused pain to this area. Seventy five percent of the pressure that caused pain to the non-allodynic area (up to the subject’s pain/pressure threshold) was then applied to the allodynic area, and an 11-point Numerical Rating Scale pain score recorded (between 0 (no pain)and 10 (most intense pain imaginable)). A negative value indicates an improvement in pain score from baseline.|Day 0 - Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis||units on a scale||Standard Deviation|Mean
770574|NCT00711880|Secondary|Change From Baseline in Mean Dynamic Allodynia Test Score at the End of Treatment|Dynamic allodynia was assessed by stroking the skin over the affected area five times with a standardised brush, designed specifically for sensory testing at 5sec intervals, and recording the pain severity on a 0–10 point scale (0= no pain to 10 = most pain imaginable). All strokes were of the same length, minimum 2 cm. Each dynamic allodynia score was calculated as the average of the five strokes. A negative change from baseline indicates an improvement in score.|Day 7 and Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis||units on a scale||Standard Deviation|Mean
770575|NCT00711880|Secondary|Change From Baseline in the Mean Pain Disability Index Score at the End of Treatment|The Pain Disability Index consisted of seven self-administered questions relating to the effect of the subject’s chronic pain on their personal life (family/home responsibilities, social activity, sexual behaviour, life-support activity, recreation, occupation and self-care). Each assessment was scored on an 11-point Numerical Rating Scale ranging from 0 (which equals ‘no disability’) to 10 (which equals ‘total disability’). The total Pain Disability Index is the unweighted sum of the seven Numerical Rating Scale scores. The maximum (worst) total score was 70.|Day 0 - Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis||units on a scale||Standard Deviation|Mean
770576|NCT00711880|Secondary|Change From Baseline in Mean Sleep Quality at the End of Treatment|"The sleep disruption NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate how your pain disrupted your sleep last night? where 0 = did not disrupt sleep and 10 = completely disrupted (unable to sleep at all). A negative value indicates an improvement in sleep disruption score from baseline."|Day 7 - Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis||units on a scale||Standard Deviation|Mean
770577|NCT00711880|Secondary|Change From Baseline in Mean Neuropathic Pain Scale Score at the End of Treatment|The Neuropathic Pain Scale (NPS) score consisted of a series of assessments of different aspects of pain (intensity, sharpness, hot, dull, cold, sensitive, itchy, unpleasantness, and surface compared with deep), each scored using 11-point Numerical Rating Scales. The NPS score is 0-100 sum of 10 individual pain scores (0-10 NRS, 0= no pain to 10 = most pain imaginable). A negative change from baseline indicates an improvement in pain.|Day 0 to Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis||units on a scale||Standard Deviation|Mean
770578|NCT00711880|Primary|Change From Baseline in the Mean Daily Peripheral Neuropathic Pain on a 0-10 Numerical Rating Scale Score During the Last Seven Days of Treatment (End of Treatment)|"The neuropathic pain Numerical Rating Scale was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours where 0 = no pain and 10 = worst possible pain. A negative value indicates an improvement in pain score from baseline."|Day 0 to Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis||units on a scale||Standard Deviation|Mean
770583|NCT00711971|Other Pre-specified|NICU (Neonatal Intensive Care Unit) Admissions|Admission to the NICU|6 weeks post delivery|One set of twins in group A||Participants|||Count of Participants
770584|NCT00711971|Other Pre-specified|Neonatal Birthweight|Mean weight in grams: where <2500 gm is considered small for gestational age and >4500 gm is considered large for gestational age.|immediately after birth|Data is provided for all babies on whom delivery weights were available with a set of twins in EPA rich fish oil arm and a delivery elsewhere for whom no birth weight was available for one baby from a mother in the Soy oil placebo arm. Thus there is 1 more participant than mothers participating in the EPA-rich arm and one less in the soy oil arm.||grams||Standard Deviation|Mean
770585|NCT00711971|Other Pre-specified|Estimated Blood Loss (ml)||Within 24 hours after delivery|||mL||Standard Deviation|Mean
770586|NCT00711971|Other Pre-specified|Gestational Age at Delivery (Weeks)||delivery date was assessed by medical record review between 1 day and 8 weeks after delivery|Gestational age is measured based on the pregnancy not the neonates, therefore although there were 40 babies born to the 39 mothers randomized to the EPA-rich fish oil, it is proper to consider the participants analyzed to be the 39 participating mothers. This is clarified still further by identifying the units appropriately as pregnancies.||weeks|pregnancies|Standard Deviation|Mean
770587|NCT00711971|Other Pre-specified|Maternal Outcomes|While the maternal outcomes assess criteria during pregnancy and relating to delivery they were assessed at visits 26 - 28 weeks gestational age, 34-36 weeks gestational age and at the post partum visit 6- 8 weeks after delivery.|visits at 26 - 28 weeks gestational age, 34-36 weeks gestational age during pregnancy and at the post partum visit 6- 8 weeks after delivery|"Gestational hypertension and diabetes were self-reported for all participants so her data is included for those two rows.
One woman in the soy placebo arm delivered out of the geographic area, so documentation of delivery outcome is unavailable for analysis."||participants|||Number
770588|NCT00711971|Primary|Beck Depression Inventory|The Beck Depression inventory scores depression based on 21 items, with a score of 0 - 3 on each item where 0 is no depression and a score of 31 or more is clinically depressed. The 21 items were summed to obtain the total score (The maximum possible score is 63.)|6 - 8 weeks postpartum|Per protocol analysis is reported here.||units on a scale||Standard Deviation|Mean
770589|NCT00711997|Primary|Maximal Tolerated Dose (MTD) & Dose Limiting Toxicity (DLT) of Intratumoral Injections of BC-819|Number of Participants Reaching Maximal Tolerated Dose (MTD)|Week 4|All participants had to receive all 4 scheduled treatments and completed the Week 4 assessment||participants|||Number
770590|NCT00711997|Secondary|Tumor Resectability|The number of subjects in each cohort whose tumor was resectable at the end of the study was to be presented for the ITT and the per-protocol population.|5 to 6 weeks|||participants|||Number
770591|NCT00711997|Secondary|Tumor Response|Tumor response and progression were defined in accordance with RECIST v. 1.0 and assessed by radiological examination 2 weeks after the end of treatment|4 weeks|||participants|||Number
770592|NCT00712010|Primary|Calculation of the Area Under Curve Over Baseline for Plasma Insulin|The concentrations of insulin were analyzed in the 10 plasma samples collected over 3 h postprandially in all subjects (Baseline, 10, 20, 30, 45, 60, 90, 120, 150, and 180 min after product intake). The Area-Under-the-Curves (AUC) over 180 minutes from baseline were calculated by trapezoidal interpolation by excluding the area under baseline.|180 minutes from baseline|||nmole/L*min||Standard Error|Mean
770593|NCT00712010|Secondary|Post-prandial Plasma Responses of Glucagon, C-peptide, Amino Acids and Lipids||180 minutes||||||
770594|NCT00712010|Primary|Post-prandial Plasma Responses of Glucose Concentrations|The concentrations of glucose were analyzed in the 10 plasma samples collected over 3 h postprandially in all subjects (Baseline, 10, 20, 30, 45, 60, 90, 120, 150, and 180 min after product intake). The Area-Under-the-Curves (AUC) over 180 minutes from baseline were calculated by trapezoidal interpolation by excluding the area under baseline.|180 minutes|23 subjects were investigated for AUC of glucose calculations||mmole/L*min||Standard Error|Mean
770595|NCT00712075|Secondary|Positive and Negative Syndrome Scale (PANSS)|The PANSS is 30 item semi-structured clinical interview designed to assess positive and negative symptoms. The PANSS consists of 7 items on the positive symptom subscale, 7 items on the negative symptom subscale, and 16 items on the general psychopathology subscale. Each item in the subscale is rated from 0 (absence of symptom) to 7 (extreme symptom severity). Scores of each subscale are summed to yield a total score range of 30 (Absence of symptoms) to 210, where higher scores represent more severe symptoms.|Baseline, at mid-treatment (3-mo), at end-of-treatment (6-mos), and at 6-mo follow-up (12 mos post-baseline)|||units on a scale||Standard Deviation|Mean
770596|NCT00712075|Secondary|Comprehensive Module Test (CMT)|The Comprehensive Module Test (CMT) is an assessment of CBSST skills acquisition in three domains: Communication Skills Test, Problem Solving Test, and Thought Challenging Test. The total CMT score ranges from 0-33. Higher total scores represent higher level of CBSST skills acquisition.|Baseline, at mid-treatment (3-mo), at end-of-treatment (6-mos), and at 6-mo follow-up (12 mos post-baseline)|||units on a scale||Standard Deviation|Mean
770597|NCT00712075|Primary|Independent Living Skills Survey (ILSS)|The ILSS is a self-report measure in an interview format to assess everyday functioning in ten domains: Appearance and Clothing, Personal Hygiene, Care of Personal Possessions, Food Preparation/Storage, Health Maintenance, Money Management, Transportation, Leisure, Job Seeking, and Job Maintenance. Scale ranges from 0 to 1. Subscales are averaged to yield composite score. Higher scores represent a higher level of functioning.|Baseline, at mid-treatment (3-mo), at end-of-treatment (6-mos), and at 6-mo follow-up (12 mos post-baseline)|Due to incomplete ILSS data for one participant in the CBSST group, 25 of 26 participants were included in the analyses for this measure.||units on a scale||Standard Deviation|Mean
770598|NCT00712166|Secondary|Relative Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Percent Predicted|Spirometry was performed according to American Thoracic Society (ATS) guidelines at each visit. Treatment effect on the relative change from baseline in FEV1 percent predicted at Day 28 (Visit 4) was tested by the ANCOVA model using the ITT analysis set. Baseline FEV1 percent predicted and age group (<18 vs. >=18 years) were included as covariates in the analysis.|Day 0 to Day 28|Analysis based on ITT population (all participants who received at least part of one dose of AZLI or placebo). Missing baseline data were not imputed. Missing post-baseline data were imputed using worst-case value for participants who withdrew due to an AE or study drug intolerance. For all other missing data, LOCF method was used.||Percent change from baseline||Standard Error|Least Squares Mean
770624|NCT00712335|Secondary|Sputum Eosinophil Percentages|Secondary endpoints of inflammatory markers (sputum eosinophil percentages at 24 weeks) were measured in active treatment groups|24 weeks|We will use ITT and PP protocols for analysis||percentage of eosinophils||Standard Deviation|Mean
770599|NCT00712166|Secondary|Change From Baseline in Log10 Pseudomonas Aeruginosa (PA) Colony Forming Units (CFUs) in Sputum at Day 28|Sputum samples were collected at all study visits for quantitative and qualitative culture for PA. Sputum PA density was quantified by logarithm transformation of the CFU value with base 10. Change from baseline in sputum PA density was calculated as the difference between the log10 CFU values at Day 28 (Visit 4) and the baseline value. Missing data was not imputed. Baseline log10 CFU and age group (<18 vs. >=18 years) were included as covariates in the analysis.|Day 0 to Day 28|Analysis based on ITT population (all participants who received at least part of one dose of AZLI or placebo). No imputation methods were used for the analysis.||Log10 PA CFUs/gram of sputum||Standard Error|Least Squares Mean
770600|NCT00712166|Other Pre-specified|The Minimum Concentrations of Aztreonam That Inhibit 50% and 90% of All PA Isolates (MIC50 and MIC90, Respectively)|Aztreonam susceptibility of PA isolates from expectorated sputum samples (collected at all visits) was assessed. The minimum inhibitory concentration (MIC) is the lowest concentration of antimicrobial agent that inhibits visible growth of a microorganism. The MIC50 and MIC90 for PA is the MIC required to inhibit the growth of 50% or 90% of PA isolates, respectively. Given that there might be multiple PA isolates for each participant, the MIC50 and MIC90 for PA was calculated using the MIC values for all PA isolates. The MIC50 and MIC90 were calculated by treatment group.|Day 0 to Day 28|Analysis based on ITT population (all participants who received at least part of one dose of AZLI or placebo).||µg/mL|||Number
770601|NCT00712166|Other Pre-specified|Number of Participants Testing Positive for Other Respiratory Pathogens|Sputum/throat swab samples were collected at all visits for quantitative and qualitative culture of Burkholderia species, Stenotrophomonas maltophilia, Achromobacter xylosidans, methicillin-resistant Staphylococcus aureus (MRSA), methicillin-sensitive S. aureus (MSSA), and Aspergillus species. One CFU on the culture from either a sputum or throat swab sample was considered presence of the particular organism.|Day 0 to Day 28|Analysis based on ITT population (all participants who received at least part of one dose of AZLI or placebo). No imputation methods were used for the analysis.||Participants|||Number
770602|NCT00712166|Secondary|Number of Participants Hospitalized During Study|Hospitalization was defined as any hospital admission lasting for more than 1 calendar day that had been recorded as a serious adverse event (SAE) on the electronic case report form (eCRF). Binary variables were defined to indicate whether participants experienced any hospitalization. Number of hospitalizations was summarized by treatment group.|Day 0 to Day 42|Analysis based on ITT population (all participants who received at least part of one dose of AZLI or placebo). No imputation methods were used for the analysis.||Study participants|||Number
770603|NCT00712166|Secondary|Number of Participants Using Additional (Nonprotocol-specified) Antipseudomonal Antibiotics During Study|The number of participants requiring additional antipseudomonal antibiotics (oral, intravenous [IV], or by inhalation), the time to use of these antibiotics, and the reasons for use was recorded. A binary variable was defined to indicate whether the participants needed any antipseudomonal antibiotics that were non-study drug via the oral, IV, or inhalation route between Day 0 (Baseline Visit) and Day 42 (Visit 5). Fisher’s Exact Test was implemented on the intent-to-treat (ITT) and per protocol analysis sets to detect treatment effects on need for additional antipseudomonal antibiotics.|Day 0 to Day 42|Analysis based on ITT population (all participants who received at least part of one dose of AZLI or placebo). No imputation methods were used for the analysis.||Participants|||Number
770604|NCT00712166|Secondary|Change From Baseline in CFQ-R Physical Functioning Domain Score|The CFQ-R contains both general and CF-specific scales. The CFQ-R was administered at Days 0 (baseline), 14, 28, and 42 (the last study visit). The endpoint was change from baseline in the physical functioning domain (e.g., ability to walk and engage in physical activities) of the CFQ-R at Day 28 (range of scores: 0-100; higher scores indicating fewer symptoms, higher health-related quality of life, or better functioning). Baseline CFQ-R physical functioning domain score and age group (<18 vs. >=18 years) were included as covariates in the analysis.|Day 0 to Day 28|Analysis based on ITT population (all participants receiving at least part of one dose of AZLI or placebo). Missing baseline data were not imputed. Missing post-baseline data were imputed using worst-case value for participants who withdrew due to an AE or study drug intolerance. For all other missing data, LOCF imputation method was used.||Units on a scale||Standard Error|Least Squares Mean
770605|NCT00712166|Secondary|Change From Baseline in CFQ-R RSS Score at Day 42|The CFQ-R is a validated patient-reported outcome measuring health-related quality of life for children and adults with CF. The CFQ-R contains both general and CF-specific scales. The CFQ-R was administered at Days 0, 14, 28, and 42. The endpoint was change in respiratory symptoms (e.g., coughing, congestion, wheezing) from Day 0 (baseline), assessed with the CFQ-R RSS (score range: 0-100; higher scores indicating fewer symptoms, higher health-related quality of life, or better functioning). Baseline CFQ-R RSS and age group (<18 vs. >=18 years) were included as covariates in the analysis.|Day 0 to Day 42|Analysis based on ITT population (all participants receiving at least part of one dose of AZLI or placebo). Missing baseline data were not imputed. Missing post-baseline data were imputed using worst-case value for participants who withdrew due to an AE or study drug intolerance. For all other missing data, LOCF imputation method was used.||Units on a scale||Standard Error|Least Squares Mean
770606|NCT00712166|Secondary|Change From Baseline in CFQ-R RSS Score at Day 14|The CFQ-R is a validated patient-reported outcome measuring health-related quality of life for children and adults with CF. The CFQ-R contains both general and CF-specific scales. The CFQ-R was administered at Days 0, 14, 28, and 42. The endpoint was change in respiratory symptoms (e.g., coughing, congestion, wheezing) from Day 0 (baseline), assessed with the CFQ-R RSS (score range: 0-100; higher scores indicating fewer symptoms, higher health-related quality of life, or better functioning). Baseline CFQ-R RSS and age group (<18 vs. >=18 years) were included as covariates in the analysis.|Day 0 to Day 14|Analysis based on ITT population (all participants receiving at least part of one dose of AZLI or placebo). Missing baseline data were not imputed. Missing post-baseline data were imputed using worst-case value for participants who withdrew due to an AE or study drug intolerance. For all other missing data, LOCF imputation method was used.||Units on a scale||Standard Error|Least Squares Mean
770625|NCT00712348|Primary|Hemoglobin||Every 3 months from Baseline to Month 9|||g/dL||Standard Deviation|Mean
770626|NCT00712348|Other Pre-specified|Liver Volume|Liver volume measured by MRI|Baseline and 9 months|2 patients were MRI phobic||mL||Standard Deviation|Mean
770627|NCT00712348|Other Pre-specified|Spleen Volume|Spleen volume measured by MRI in mL|Baseline and 9 Months|25 patients had spleen volume measured by MRI, 2 were MRI phobic and 3 were splenectomized||mL||Standard Deviation|Mean
770607|NCT00712166|Primary|Change From Baseline in Cystic Fibrosis Questionnaire – Revised (CFQ-R) Respiratory Symptoms Scale (RSS) Score at Day 28|The CFQ-R is a validated patient-reported outcome measuring health-related quality of life for children and adults with CF. The CFQ-R contains both general and CF-specific scales. The CFQ-R was administered at Days 0, 14, 28, and 42. The endpoint was change in respiratory symptoms (e.g., coughing, congestion, wheezing) from Day 0 (baseline), assessed with the CFQ-R RSS (score range: 0-100; higher scores indicating fewer symptoms, higher health-related quality of life, or better functioning). Baseline CFQ-R RSS and age group (<18 vs. >=18 years) were included as covariates in the analysis.|Day 0 to Day 28|Analysis on intent-to-treat (ITT) population (received at least part of 1 dose of AZLI/placebo). Missing baseline data not imputed. Missing post-baseline data imputed with worst-case value for participants who withdrew due to an adverse event (AE)/study drug intolerance. Imputation for other missing data was last observation carried forward (LOCF).||Units on a scale||Standard Error|Least Squares Mean
770608|NCT00712179|Primary|Diagnostic|"The electromyographic (EMG) gait pattern of stroke survivors was compared with normal pattern using z-scores."|During sessions- 1 day measurement|Individuals with chronic stroke.||Z-score||Standard Error|Mean
770609|NCT00712244|Secondary|Surgeon Surgey - Anterior Dome Maintenance During Intraocular Lens (IOL) Insertion|Surgeon reporting of Anterior Chamber Dome Maintenance of a subject's eye during intraocular lens (IOL) insertion. Evaluated on a subjective scale and reported as percent by response. The following scale is used, from worst to best: Flat, Shallow, Working Space Adequate, Full Chamber Maintenance.|Time of Surgery|This data was collected on all subjects undergoing surgery with the exception of 1 DuoVisc subject.||Percentage of participants|||Number
770610|NCT00712244|Secondary|Surgeon Surgey - Anterior Dome Maintenance During Phacoemulsification|Surgeon reporting of Anterior Chamber Dome Maintenance of a subject's eye during phacoemulsification. Evaluated on a subjective scale and reported as percent by response. The following scale is used, from worst to best: Flat, Shallow, Working Space Adequate, Full Chamber Maintenance.|Time of Surgery|This data was collected on all subjects undergoing surgery with the exception of 1 DuoVisc subject.||Percentage of participants|||Number
770611|NCT00712244|Secondary|Surgeon Survey - Anterior Chamber Dome Maintenance During Anterior Capsulotomy|Surgeon reporting of Anterior Chamber Dome Maintenance of a subject's eye during anterior capsulotomy. Evaluated on a subjective scale and reported as percent by response. The following scale is used, from worst to best: Flat, Shallow, Working Space Adequate, Full Chamber Maintenance.|Time of surgery|This data was collected on all subjects undergoing surgery with the exception of 1 DuoVisc subject.||Percentage of participants|||Number
770612|NCT00712244|Secondary|Intraocular Pressure (IOP)|Measure of intraocular pressure of a patient's eye via tonometry one day after surgery. Measured in mmHg. Normal intraocular pressure is between 10 mmHg and 20 mmHg.|1 day after surgery|This data was collected on all subjects attending the visit one day after surgery with the exception of 3 DisCoVisc subjects, 4 DuoVisc subjects, 2 Healon5 subjects, and 1 AmVisc Plus subject.||mmHg||Standard Deviation|Mean
770613|NCT00712244|Secondary|Aqueous Signs - Aqueous Cells|Measured as the percentage of patient's eyes subjectively evaluated to have Aqueous Cells at each of the following gradings: 0 - None, 1 - 1 to 5 cells, 2 - 6 to 15 cells, 3 - 16 - 30 cells, 4 - >30 cells.|1 day after surgery|This data was collected for all subjects attending the visit one day after surgery.||Percentage of participants|||Number
770614|NCT00712244|Secondary|Aqueous Signs - Aqueous Flare|Measured as the percentage of patient's eyes subjectively evaluated to have Aqueous Flare at each of the following gradings: 0 - None: No visible flare when compared to the normal eye, 1 - Mild: Flare visible against dark papillary background but not visible against iris background, 2 - Moderate: Flare is visible with the slit-lamp beam aimed onto the iris surface as well as teh dark papillary background, 3 - Severe: Very dense flare. May also present as a hazy appearance of anterior segment structures when viewed with low power magnification of the slit-lamp.|1 Day after Surgery|This data was collected for all subjects attending the visit one day after surgery.||Percentage of participants|||Number
770615|NCT00712244|Secondary|Aqueous Signs - Corneal Edema|Measured as the percentage of patient's eyes subjectively evaluated to have corneal edema at each of the following gradings: 0 - none; 1 - Mild, slight localized or generalized edema; 2 - Moderate, significant localized or generalized edema; 3 - Severe, advanced localized or generalized edema.|1 day after surgery|This data was collected for all subjects attending the visit one day after surgery.||Percentage of Participants|||Number
770616|NCT00712244|Secondary|Percent Gain in Corneal Thickness.|Percent Gain in Corneal Thickness between the assessment performed before surgery to that performed after surgery. This was assessed at both the 1 week and 1 month visit. Corneal thickness is measured in micrometers and is evaluated by Pachymetry. A negative number indicates a decrease in corneal thickness.|1 week and month after surgery|Participants analyzed for Baseline to 1 week: 29 DisCovisc, 28 DuoVisc, 26 Healon5, 26 Amvisc Plus.||Percent Gain||Standard Deviation|Mean
770617|NCT00712244|Primary|Corneal Endothelial Cell Loss|Percentage of corneal endothelial cells lost 1 month after surgery as compared to the number of corneal endothelial cells measured before surgery. Corneal endothelial cells are measured by counting the number of cells on an image taken by specular microscope.|1 month after surgery|||Percent Change||Standard Deviation|Mean
770618|NCT00712335|Secondary|Sputum RANTES Levels|Week 24 sputum RANTES levels in active treatment groups were measured.|24 weeks|ITT and PP were used for analysis.||pg/ml||Standard Deviation|Mean
770619|NCT00712335|Secondary|Sputum Eotaxin Levels|Week 24 sputum eotaxin levels in active treatment groups were measured.|24 weeks|ITT and PP were used for analysis.||pg/ml||Standard Deviation|Mean
770620|NCT00712335|Secondary|Sputum IFN-gamma/IL-5 Ratios|Week 24 sputum IFN-gamma/IL-5 ratios were determined in active treatment groups.|24 weeks|ITT and PP were used for analysis.||ratio||Standard Deviation|Mean
770621|NCT00712335|Secondary|Sputum GM-CSF Levels|Week 24 sputum GM-CSF levels in active treatment groups were measured.|24 weeks|We will use ITT and PP for analysis||pg/ml||Standard Deviation|Mean
770622|NCT00712335|Secondary|Sputum IL-8 Levels|Week 24 sputum IL-8 levels in active treatment groups|24 weeks|We will ITT and PP protocols for analysis||pg/ml||Standard Deviation|Mean
770623|NCT00712335|Primary|Sputum Neutrophil Percentages|Week 24 sputum neutrophil percentages were measured in active treatment groups.|24 weeks|We will be using intention-to-treat and per protocol for analysis.||percentage of neutrophils||Standard Deviation|Mean
770628|NCT00712348|Other Pre-specified|Platelet Count||Every 3 months from Baseline to Month 9|||platelets/mm^3||Standard Deviation|Mean
770629|NCT00712530|Other Pre-specified|Change in HIV-specific Memory T Cell Responses at Week 48|"HIV-specific T cell precursors with high proliferative capacity (PHPC) were quantified as described earlier [Calarota et al. J Immunol 2008]. Gag-, Tat- and Rev-specific T cells were measured representing ca. 25% of HIV epitopes included in DermaVir.
Note, group Single low-dose was measured at 24 weeks, for this group the 48 weeks data is not available"|48 weeks|||PHPC count||Standard Deviation|Mean
770630|NCT00712530|Secondary|Change in HIV-specific Memory T Cell Responses at Day 28 Compare to Baseline|HIV-specific T cell precursors with high proliferative capacity (PHPC) were quantified as described earlier [Calarota et al. J Immunol 2008]. Gag-, Tat- and Rev-specific T cells were measured representing ca. 25% of HIV epitopes included in DermaVir.|28 days|||PHPC count||Standard Deviation|Mean
770631|NCT00712530|Secondary|Number of Subjects Having More Than 50 Copies/mL HIV RNA||28 days|||participants|||Number
770632|NCT00712530|Secondary|Number of Subjects With Detectable Anti-ds Antibody and ANA||28 days|||participants|||Number
770633|NCT00712530|Secondary|CD4+ T Cell Counts/mm3||28 days|||CD4+ T cell counts/mm3||Standard Deviation|Mean
770634|NCT00712530|Primary|Grade 3 Adverse Event Related to DermaVir Treatment|Occurrence of at least one grade 3 or higher adverse event including signs/symptoms, laboratory toxicities and clinical events possibly, probably or definitely related to study treatment as judged by the Principal Investigator or the site investigators during the 28 days after DermaVir administration.|28 days|||participants|||Number
770635|NCT00712543|Primary|Patient Preference in Terms of Overall Preference and Preference of Taste, Consistency, and Portability.||14 days|||participants|||Number
770636|NCT00712673|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.||percentage of participants|||Number
770637|NCT00712673|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.||percentage of participants|||Number
770638|NCT00712673|Secondary|Percentage of Patients Requiring Rescue Therapy During the Main 24-Week Period|Routine fasting self-monitored plasma glucose (SMPG) and central laboratory FPG (and HbA1c after week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after week 12) were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG >270 milligram/deciliter (mg/dL) (15.0 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 24: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >8.5%. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline up to Week 24|mITT population.||percentage of participants|||Number
770639|NCT00712673|Other Pre-specified|Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia|Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the patient required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.|First dose of study drug up to 3 days after the last dose administration|Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.||participants|||Number
770640|NCT00712673|Other Pre-specified|Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.||percentage of participants|||Number
770641|NCT00712673|Secondary|Change From Baseline in Beta-cell Function Assessed by Homeostasis Model Assessment for Beta-cell Function (HOMA-beta) at Week 24|Beta cell function was assessed by HOMA-beta. HOMA-beta (% of normal beta cells function) = (20 multiplied by fasting plasma insulin [micro unit per milliliter]) divided by (FPG [mmol/L] minus 3.5). Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HOMA-beta assessment during on-treatment period.||% of normal beta cells function||Standard Error|Least Squares Mean
770783|NCT00719680|Secondary|Number of Subjects With Clinically Significant Changes From Baseline to the Completion Visit in Routine Laboratory Parameters|Routine laboratory parameters included hematology, blood chemistry, and urinalysis parameters.|At Week 1, and study completion (approximately 104 weeks)|The AT safety population comprised all subjects treated with the study medication during any study period.||participants|||Number
770642|NCT00712673|Secondary|Change From Baseline in Adiponectin at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline adiponectin assessment during on-treatment period.||mcg/mL||Standard Error|Least Squares Mean
770643|NCT00712673|Secondary|Change From Baseline in 2-Hour Postprandial Glucagon at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy.|Baseline, Week 24|Subgroup for standardized meal test (patients from morning injection arms only) as pre-specified in the protocol. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline glucagon assessment during on-treatment period.||ng/L||Standard Error|Least Squares Mean
770644|NCT00712673|Secondary|Change From Baseline in Fasting Glucagon at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy.|Baseline, Week 24|Subgroup for standardized meal test (patients from morning injection arms only) as pre-specified in the protocol. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline glucagon assessment during on-treatment period.||ng/L||Standard Error|Least Squares Mean
770645|NCT00712673|Other Pre-specified|Change From Baseline in Glucose Excursion at Week 24|Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the standardized meal test, before study drug administration. Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy.|Baseline, Week 24|Subgroup for standardized meal teat. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline glucose excursion assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
770646|NCT00712673|Secondary|Change From Baseline in 2-Hour Postprandial C-Peptide at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy.|Baseline, Week 24|Subgroup for standardized meal test (patients from morning injection arms only) as pre-specified in the protocol. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline C-peptide assessment during on-treatment period.||nmol/L||Standard Error|Least Squares Mean
770647|NCT00712673|Secondary|Change From Baseline in Fasting C-Peptide at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy.|Baseline, Week 24|Subgroup for standardized meal test (patients from morning injection arms only) as pre-specified in the protocol. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline C-peptide assessment during on-treatment period.||nmol/L||Standard Error|Least Squares Mean
770648|NCT00712673|Secondary|Change From Baseline in 2-Hour Postprandial Proinsulin at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy.|Baseline, Week 24|Subgroup for standardized meal test (patients from morning injection arms only) as pre-specified in the protocol. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline proinsulin assessment during on-treatment period.||pmol/L||Standard Error|Least Squares Mean
770649|NCT00712673|Secondary|Change From Baseline in Fasting Proinsulin at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy.|Baseline, Week 24|Subgroup for standardized meal test (patients from morning injection arms only) as pre-specified in the protocol. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline proinsulin assessment during on-treatment period.||pmol/L||Standard Error|Least Squares Mean
770650|NCT00712673|Secondary|Change From Baseline in 2-Hour Postprandial Plasma Insulin (PPI) at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to the last dosing day of the study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy.|Baseline, Week 24|Subgroup for standardized meal test (patients from morning injection arms only) as pre-specified in the protocol. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline PPI assessment during on-treatment period||pmol/L||Standard Error|Least Squares Mean
770659|NCT00718302|Secondary|SMFA - Bother Index|The Bother Index is part of the SMFA. This section focuses on how much the injury is bothering the subject in terms of daily activities and use of injured area. The index totals are between 0-100. The lower the score, the less bothered the subject is by their injury.|3 months, 6 months, 12 months|Participants analyzed at 3 months - 88 (AP) / 89 (LP) Participants analyzed at 6 months - 68 (AP) / 67 (LP) Participants analyzed at 12 months - 53 (AP) / 51 (LP) Numbers differ due to incomplete data collection or subjects were lost to follow up.||units on a scale||Standard Deviation|Mean
770651|NCT00712673|Secondary|Change From Baseline in Fasting Plasma Insulin (FPI) at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline plasma insulin assessment during on-treatment period.||pmol/L||Standard Error|Least Squares Mean
770652|NCT00712673|Secondary|Change From Baseline in Body Weight at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.||kilogram||Standard Error|Least Squares Mean
770653|NCT00712673|Secondary|Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Week 24|The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to the last dosing day of the study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy.|Baseline, Week 24|Subgroup for standardized meal test (patients from morning injection arms only) as pre-specified in the protocol. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline 2-hour PPG assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
770654|NCT00712673|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using last observation carried forward (LOCF). Here, number of patients analyzed = patients with baseline and at least 1 post-baseline FPG assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
770655|NCT00712673|Primary|Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|Absolute change = HbA1c value at Week 24 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in Modified Intent-to-treat (mITT) population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population:all randomized patients who received at least 1 dose;had baseline,at least 1 post-baseline efficacy assessment, irrespective of compliance with study protocol/procedures. Last observation carried forward used. Number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.||percentage of hemoglobin||Standard Error|Least Squares Mean
770656|NCT00718237|Secondary|Number of Participants With Severe Rotavirus Gastroenteritis Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With Serotype P1A|Severe cases of rotavirus gastroenteritis caused by G1, G2, G3, G4 or G-serotypes associated with serotype P1A occurring at least 14 days postdose 3 in the per-protocol population using per-protocol case definition. Severity score was calculated based on frequency and duration of diarrhea, vomiting, elevated temperature, and behavioral changes. Score of >8 and <=16 was considered moderate, and >16 was considered severe.|At least 14 days following the 3rd vaccination|Per Protocol Population; number randomized is different from number analyzed due to some data excluded from the analysis (e.g., protocol violators, unevaluable due to detection of wild-type rotavirus in stool antigen prior to 14 days Postdose 3, incomplete clinical and/or laboratory results, or stool samples collected out of day range).||Number of participants|||Number
770657|NCT00718237|Primary|Number of Participants With Rotavirus Gastroenteritis of Any Severity Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With Serotype P1A|Any severity cases of rotavirus gastroenteritis caused by G1, G2, G3, G4 or G-serotypes associated with serotype P1A occurring at least 14 days postdose 3 in the per-protocol population using per-protocol case definition|At least 14 days following the 3rd vaccination|Per Protocol Population; number randomized is different from number analyzed due to some data excluded from the analysis (e.g., protocol violators, unevaluable due to detection of wild-type rotavirus in stool prior to 14 days Postdose 3, incomplete clinical and/or laboratory results, or stool samples collected out of day range).||Number of participants|||Number
770658|NCT00718237|Secondary|Number of Participants With Moderate to Severe Rotavirus Gastroenteritis Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With Serotype P1A|Moderate to severe cases of rotavirus gastroenteritis caused by G1, G2, G3, G4 or G-serotypes associated with serotype P1A occurring at least 14 days postdose 3 in the per-protocol population using per-protocol case definition. Severity score was calculated based on frequency and duration of diarrhea, vomiting, elevated temperature, and behavioral changes. Score of >8 and <=16 was considered moderate, and >16 was considered severe.|At least 14 days following the 3rd vaccination|Per Protocol Population; number randomized is different from number analyzed due to some data excluded from the analysis (e.g., protocol violators, unevaluable due to detection of wild-type rotavirus in stool prior to 14 days Postdose 3, incomplete clinical and/or laboratory results, or stool samples collected out of day range).||Number of participants|||Number
770784|NCT00719680|Secondary|Number of Subjects With Clinically Significant Changes From Baseline to the Completion Visit in Vital Signs|Vital signs included blood pressure (systolic and diastolic), heart rate, and body temperature.|At weeks 1, 12, 24, 36, 48, 60, 72, 84, and 96|The AT safety population comprised all subjects treated with the study medication during any study period.||participants|||Number
770660|NCT00718302|Secondary|The Short Musculoskeletal Functional Assessment (SMFA) Score|The Short Musculoskeletal Functional Assessment (SMFA) score. The questionnaire consists of four categories: Daily Activities, Emotional Status, Arm and Hand Function, Mobility. All categories are scored together, totaling between 0-100. The lower the score, the better the subjects function.|3 months, 6 months, 9 months|Participants analyzed at 3 months - 88 (AP) / 89 (LP) Participants analyzed at 6 months - 68 (AP) / 67 (LP) Participants analyzed at 12 months - 53 (AP) / 51 (LP) Numbers differ due to incomplete data collection or subjects were lost to follow up.||units on a scale||Standard Deviation|Mean
770661|NCT00718302|Secondary|American Orthopedic Foot and Ankle Society Score (AOFAS) Scores|American Orthopedic Foot and Ankle Society Score (AOFAS) score. The questionnaire consists of nine items that are distributed over three categories: Pain (40 points), function (50 points) and alignment (10 points). These are all scored together for a total of 100 points. A subject can score anywhere from 0-100, 100 being best.|3 months, 6 months, 12 months|Participants analyzed at 3 months - 88 (AP) / 89 (LP) Participants analyzed at 6 months - 68 (AP) / 67 (LP) Participants analyzed at 12 months - 53 (AP) / 51 (LP) Numbers differ due to incomplete data collection or subjects were lost to follow up.||units on a scale||Standard Deviation|Mean
770662|NCT00718302|Secondary|Percentage Normal Peroneal Tendons|Percentage of Participants with Normal Peroneal Tendons|3 months, 6 months, 12 months|Participants analyzed at 3 months - 88 (AP) / 89 (LP) Participants analyzed at 6 months - 68 (AP) / 67 (LP) Participants analyzed at 12 months - 53 (AP) / 51 (LP) Numbers differ due to incomplete data collection or subjects were lost to follow up.||percentage of participants|||Number
770663|NCT00718302|Primary|Percentage of Nonpalpable Hardware|Percentage of Participants with Nonpalpable Hardware|3 months, 6 months, 12 months|Participants analyzed at 3 months - 88 (AP) / 89 (LP) Participants analyzed at 6 months - 68 (AP) / 67 (LP) Participants analyzed at 12 months - 53 (AP) / 51 (LP)||percentage of participants|||Number
770664|NCT00718315|Secondary|Percentage of Participants With Pain Stratified by Severity Grade|The severity of pain was graded on a 5 point scale where 0 (equals)= absent, 1= mile, 2=moderate, 3= severe, 4= life threatening and 5= Death; Severity graded by oncologist.|30 Days|ITT Population||percentage of participants|||Number
770665|NCT00718315|Secondary|Percentage of Participants With Pruritus Stratified by Severity Grade|The severity of skin rash was graded on a 5 point scale where 0 (equals)= absent, 1= mile, 2=moderate, 3= severe, 4= life threatening and 5= Death; Severity graded by oncologist.|30 Days|ITT Population||percentage of participants|||Number
770666|NCT00718315|Secondary|Percentage of Participants With Erythema Stratified by Severity Grade|The severity of skin rash was graded on a 5 point scale where 0 (equals)= absent, 1= mile, 2=moderate, 3= severe, 4= life threatening and 5= Death; Severity graded by oncologist.|30 Days|ITT Population||percentage of participants|||Number
770667|NCT00718315|Secondary|Percentage of Participants With Pain|Pain is defined as an unpleasant feeling often caused by intense or damaging stimuli|Days 0, 15, and 30|ITT Population||percentage of participants||95% Confidence Interval|Number
770668|NCT00718315|Secondary|Percentage of Participants With Pruritus|Pruritus is defined as intense localized itching|Days 0, 15, and 30|ITT Population||percentage of participants||95% Confidence Interval|Number
770669|NCT00718315|Secondary|Percentage of Participants With Erythema|Erythema is defined as redness of the skin or mucous membranes, caused by hyperemia of superficial capillaries|Days 0, 15, and 30|ITT Population||percentage of participants||95% Confidence Interval|Number
770670|NCT00718315|Secondary|Time to Appearance of Skin Rash|Time to occurence of skin rash was calculated as the number of days from Day 0 until the first appearance of skin rash as defined by NCI-CTCAE|Days 0, 15, and 30|ITT Population||Days||95% Confidence Interval|Median
770671|NCT00718315|Primary|Percentage of Participants With Skin Rash Stratified by Severity Grade|The severity of skin rash was graded on a 5 point scale where 0 (equals)= absent, 1= mile, 2=moderate, 3= severe, 4= life threatening and 5= Death|30 Days|ITT Population||percentage of participants|||Number
770672|NCT00718315|Primary|Percentage of Participants Who Develop Skin Rash|Skin rash was assessed by the investigator and dermatologists (the latter ones only through pictures) and scored according to (National cancer Institute -Common Terminology Criteria for Adverse Events ) NCI-CTCAE ( version 3 (line “Rash/desquamation” – short name “rash”).|30 Days|ITT Population||percentage of participants||95% Confidence Interval|Number
770674|NCT00718770|Primary|Change in Tumor Size|To assess the tumor response of recurrent or metastatic radioiodine resistant thyroid cancer to bexarotene therapy using standard RECIST criteria|1 year|Adults with radioiodine resistant metastatic follicular cell derived thyroid cancer||cm||Standard Deviation|Mean
770675|NCT00718809|Secondary|Expected Toxicities Including Skin Rashes and Diarrhea|Number of patients who had toxicities classified as skin rashes and diarrhea within the adverse events.|Up to 5 years|All patients||participants|||Number
770676|NCT00718809|Secondary|Disease Control Rate|Will be examined in an exploratory fashion using Kaplan-Meier estimates. Disease control rate defined as complete response (CR) + partial response (PR) + stable disease (SD). The length of time until progression or until last evaluation will be calculated. For patients who did not progress, they will be censored in the analysis.|Up to 5 years|All patients who enrolled and received treatment||months||95% Confidence Interval|Median
770677|NCT00718809|Secondary|Overall Survival|Will be examined in an exploratory fashion using Kaplan-Meier estimates. Time until death or last evaluation will be calculated. If a patient did not die, they will be censored in the analysis.|Time from the date of registration to last reported date of survival, assessed up to 5 years|All patients who enrolled and received treatment||months||95% Confidence Interval|Median
770678|NCT00718809|Secondary|Progression-free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. This will be examined in an exploratory fashion using Kaplan-Meier estimates. Time until progression, death or last evaluation will be calculated. If a patient did not progress or die, they will be censored at their last evaluation in the analysis.|Time from the date of registration to the first reported outcome event, assessed up to 5 years|All patients who enrolled and received treatment.||months||95% Confidence Interval|Median
778136|NCT00774163|Primary|Serum Aspartate Aminotransferase (AST) in Females||Day 5|limited to females||units per liter (U/L)||Standard Deviation|Mean
770679|NCT00718809|Primary|Objective Response Rate (Complete and Partial Response)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. The objective response rate will be reported by each disease classification. The percent of patients having an objective response (complete or partial response) will be estimated with a 95% exact binomial confidence interval for the percent of patients receiving drug. Note: there were no objective responses in this trial.|Up to 5 years|All patients with at least one post baseline measurement.||percentage of participants||95% Confidence Interval|Number
770680|NCT00718861|Secondary|Change in Height at Years 7, 8 and 9 Relative to Year 6|Height was measured using a stadiometer in millimeters (mm). A stadiometer is a piece of medical equipment used for measuring height. It is usually constructed out of a ruler and a sliding horizontal headpiece which is adjusted to rest on the top of the head.|Year 6 (extension 2 baseline), Year 7, Year 8, Year 9|The intent-to-treat (ITT) population included all patients who were enrolled in the extension study at Visit 12. This included patients who were randomized to Z9 and Z6P3 groups. n = the number of patients with evaluable measurements at both Year 6 and the post-Year 6 visit, as determined by the analysis window.||millimeters (mm)||Standard Error|Least Squares Mean
770681|NCT00718861|Secondary|Mean of Time to First Clinical Fracture|The mean of time to the first clinical fracture is estimated from the area under the Kaplan-Meier curve.|over 3 years of study duration|The intent-to-treat (ITT) population included all patients who were enrolled in the extension study at Visit 12. This included patients who were randomized to Z9 and Z6P3 groups.||Days||Standard Error|Mean
770682|NCT00718861|Secondary|Number of Participants With New/Worsening Morphometric Vertebral Fractures at Year 9 Compared to Year 6|Morphometric vertebral fracture (VF) was assessed based on morphometry. QM (quantitative morphometry) incident VF(QM positive) was defined by at least a 20% decrease in any vertebral height (at least 4 mm). If a participant had a QM positive at any vertebrae at any visit, x-rays from all visits for participants were evaluated using Genant semi-quantitative (SQ) method for VF assessment. A fracture was defined as an SQ reading that was greater than the baseline SQ reading.|Year 6 (extension 2 baseline), Year 9 (3 years of study duration)|The intent-to-treat (ITT) population included all patients who were enrolled in the extension study at Visit 12. This included patients who were randomized to Z9 and Z6P3 groups. n= the number of patients with the event||participants|||Number
770683|NCT00718861|Secondary|Biomarkers (Bone Markers) Serum Bone-specific Alkaline Phosphatase (BSAP). at Year 6 (Extension 2 Baseline), Year 7, Year 8, Year 9|Bone marker analysis: All patients had blood samples collected for analysis of serum bone-specific alkaline phosphatase (BSAP).Bone-specific alkaline phosphatase (BSAP) is a useful marker of active bone formation.|Year 6 (extension 2 baseline), Year 7, Year 8, Year 9|The intent-to-treat (ITT) population included all patients who were enrolled in the extension study at Visit 12. This included patients who were randomized to Z9 and Z6P3 groups. n = the number of patients with measurements at each visit as determined by the analysis window.||ng/ml||Full Range|Median
770684|NCT00718861|Secondary|Biomarkers (Bone Markers)Serum N-terminal Propeptide of Type I Collagen (P1NP) at Year 6 (Extension 2 Baseline), Year 7, Year 8, Year 9|Bone marker analysis: All patients had blood samples collected for analysis of serum n-terminal propeptide of type I collagen (P1NP) The P1NP concentration is directly proportional to the amount of new collagen laid down during bone formation.|Year 6 (extension 2 baseline), Year 7, Year 8, Year 9|The intent-to-treat (ITT) population included all patients who were enrolled in the extension study at Visit 12. This included patients who were randomized to Z9 and Z6P3 groups. n = the number of patients with measurements at each visit as determined by the analysis window.||ng/ml||Full Range|Median
770685|NCT00718861|Secondary|Biomarkers (Bone Markers) Serum C-terminal Telopeptide of Type I Collagen (CTx) at Year 6 (Extension 2 Baseline), Year 7, Year 8, Year 9|Bone marker analysis: All patients had blood samples collected for analysis of serum c-terminal telopeptide of type I collagen (CTx). Serum CTX assays measure a fragment of the C-terminal telopeptide of type 1 collagen released during resorption of mature bone|Year 6 (extension 2 baseline), Year 7, Year 8, Year 9|The intent-to-treat (ITT) population included all patients who were enrolled in the extension study at Visit 12. This included patients who were randomized to Z9 and Z6P3 groups. n = the number of patients with measurements at each visit as determined by the analysis window.||ng/ml||Full Range|Median
770686|NCT00718861|Secondary|Percentage Change of Femoral Neck Bone Mineral Density (BMD) at Year 7, 8 and 9 Compared to Year 0|Bone Mineral Density (BMD) measured by dual energy x-ray absorptiometry (DXA). DXA consists of two X-ray beams with different energy levels that are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone. Percentage change from Year 0 = 100*(Year 9 – Year 0)/Year 0.|Year 0 (core baseline), Year 7, Year 8, Year 9|The intent-to-treat (ITT) population included all patients who were enrolled in the extension study at Visit 12. This included patients who were randomized to Z9 and Z6P3 groups. n = the number of patients with measurements at Year 0 and follow-up visits as determined by the analysis window.||percentage change of BMD||Standard Error|Least Squares Mean
770687|NCT00718861|Secondary|Percentage Change of Total Hip Bone Mineral Density (BMD) at Year 7, 8 and 9 Compared to Year 0|Bone Mineral Density (BMD) measured by dual energy x-ray absorptiometry (DXA). DXA consists of two X-ray beams with different energy levels that are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone. Percentage change from Year 0 = 100*(Year 9 – Year 0)/Year 0.|Year 0 (core baseline), Year 7, Year 8, Year 9|The intent-to-treat (ITT) population included all patients who were enrolled in the extension study at Visit 12. This included patients who were randomized to Z9 and Z6P3 groups. n = the number of patients with measurements at Year 0 and follow-up visits as determined by the analysis window.||percentage change of BMD||Standard Error|Least Squares Mean
770709|NCT00719043|Secondary|Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain.|HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome measure concerns solely the Naïve Placebo-A/turkey H5N1-Formulation 3 Group.|At Days 0, 182, 192, 224, 549, 559, 591 and 729|The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.||Titers||95% Confidence Interval|Geometric Mean
770688|NCT00718861|Secondary|Percentage Change of Femoral Neck Bone Mineral Density (BMD) at Year 7, 8 and 9 Compared to Year 6|Bone Mineral Density (BMD) measured by dual energy x-ray absorptiometry (DXA). DXA consists of two X-ray beams with different energy levels that are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone. Percentage change from Year 6 = 100*(Year 9 – Year 6)/Year 6.|Year 6 (extension 2 baseline), Year 7, Year 8, Year 9|The intent-to-treat (ITT) population included all patients who were enrolled in the extension study at Visit 12. This included patients who were randomized to Z9 and Z6P3 groups. n = the number of patients with measurements at Year 6 and follow-up visits as determined by the analysis window.||percentage change of BMD||Standard Error|Least Squares Mean
770689|NCT00718861|Secondary|Percentage Change of Total Hip Bone Mineral Density (BMD) at Year 7 and 8 Compared to Year 6|Bone Mineral Density (BMD) measured by dual energy x-ray absorptiometry (DXA). DXA consists of two X-ray beams with different energy levels that are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone. Percentage change from Year 6 = 100*(Year 9 – Year 6)/Year 6.|Year 6 (extension 2 baseline), Year 7, Year 8|The intent-to-treat (ITT) population included all patients who were enrolled in the extension study at Visit 12. This included patients who were randomized to Z9 and Z6P3 groups. n = the number of patients with measurements at Year 6 and follow-up visits as determined by the analysis window.||percentage change of BMD||Standard Error|Least Squares Mean
770690|NCT00718861|Primary|Percentage Change in Total Hip Bone Mineral Density BMD at Year 6 (Baseline) and Year 9|Bone Mineral Density (BMD) measured by dual energy x-ray absorptiometry (DXA). DXA consists of two X-ray beams with different energy levels that are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone. Percentage change from Year 6 = 100*(Year 9 – Year 6)/Year 6.|Year 6 (baseline) and Year 9|The modified intent-to-treat (MITT) population included all patients in the ITT population who had DXA measurements of the total hip at Visit 11 (Year 6) and Visit 15 (Year 9). This was the primary population for the primary efficacy parameter.||Percentage Change of BMD||Standard Error|Least Squares Mean
770691|NCT00718887|Secondary|Percentage of Participants With Grade 3 or 4 Abnormalities in Laboratory Test Results|Hematology testing assessed levels of hemoglobin, white blood cells, platelets, neutrophils, international normalized ration, red blood cells, lymphocytes, and monocytes.|Day 1 through Week 48|"Participants who were randomized and received at least
1 dose of study drug."||Percentage of participants|||Number
770692|NCT00718887|Secondary|Number of Participants With Adverse Events, Treatment-related AEs, Serious Adverse Events (SAEs), Treatment-related SAEs, Death as Outcome, Discontinuations Due to AEs, and Abnormalities in Laboratory Test Results (LTR) Leading to Discontinuation|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=possibly, probably, or certainly related to and of unknown relationship to study drug.|Continually from Day 1 through Week 48, and through 24-week follow-up period|"Participants who were randomized and received at least
1 dose of study drug."||Participants|||Number
770693|NCT00718887|Secondary|Number of Participants With Genotypic Resistance to Entecavir||At Week 48 from Day 1|"Participants who were randomized and received at least
1 dose of study drug. n=number of evaluable participants."||Participants|||Number
770694|NCT00718887|Secondary|Number of Participants With Hepatitis B s Surface Antibody (HBsAG) Loss and HBsAG Seroconversion||At Weeks 12 and 48 from Day 1|"Participants who were randomized and received at least
1 dose of study drug. n=number of evaluable participants."||Participants|||Number
770695|NCT00718887|Secondary|Percentage of Participants With Loss of Hepatitis B e Antigen (HBeAg) and Hepatitis B e (HBe) Seroconversion||At Weeks 12 and 48 from Day 1|Participants who were randomized, who received at least 1 dose of study drug, and who were HBeAg-positive at baseline. n=number of evaluable participants.||Percentage of participants|||Number
770696|NCT00718887|Secondary|Percentage of Participants Who Achieved Normalization of Alanine Aminotransferase (ALT)|ULN=upper limit of normal. ALT normalization= ≤1*ULN, among participants with baseline ALT >1*ULN|At Weeks 12 and 48 from Day 1|Participants who were randomized, who received at least 1 dose of study drug, and whose ALT values were >1*ULN at baseline. n=number of evaluable participants.||Percentage of participants|||Number
770697|NCT00718887|Secondary|Mean log10 Reduction From Baseline in Serum HBV DNA Level by Polymerase Chain Reaction Testing|HBV=hepatitis B virus|At Weeks 12 and 48 from Day 1|"Participants who were randomized and received at least
1 dose of study drug. n=number of evaluable participants."||log10 IU/mL||Standard Deviation|Mean
770698|NCT00718887|Secondary|Percentage of Participants Who Achieved an HBV DNA Level <50 IU/mL at Week 48 by Polymerase Chain Reaction Testing|HBV=hepatitis B virus. HBV DNA Level <50 IU/mL=approximately 300 copies/mL.|At Week 48 from Day 1|"Participants who were randomized and received at least
1 dose of study drug."||Percentage of participants|||Number
770699|NCT00718887|Primary|Percentage of Participants Who Achieved a Hepatitis B Virus (HBV) DNA Level <50 IU/mL at Week 12 by Polymerase Chain Reaction Testing|HBV DNA Level <50 IU/mL=approximately 300 copies/mL.|At Week 12 from Day 1|"Participants who were randomized and received at least
1 dose of study drug."||Percentage of participants|||Number
770700|NCT00719043|Secondary|Number of Seroconverted Subjects for HI Antibodies Against the A/Indo Virus Strain.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. This outcome measure only concerns the Naïve Placebo-A/turkey H5N1-Formulation 3 Group, for whom the pre-vaccination time point corresponds to the Day 192 time point.|At Days 192 and 224|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.||Subjects|||Number
770756|NCT00719329|Primary|Colonization at Day 7 Swab|Were any organisms found on the swab collected on the day 07 visit?|First Week of Life|Intent to Treat||Participants|||Number
770757|NCT00719329|Primary|Colonization at Day 3 Swab|Were any organisms found on the swab collected on at Day 03|First Week of Life|Intent to Treat||Participants|||Number
770701|NCT00719043|Secondary|Number of Seroconverted Subjects for HI Antibodies Against the A/Indo Virus Strain.|"A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. Pre-vaccination for this outcome measure corresponds to Day 0.
This outcome measure only concerns the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo, Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups."|At Days 10 and 42|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.||Subjects|||Number
770702|NCT00719043|Secondary|Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain.|A seroprotected subject was defined as a vaccinated subject with HI antibody reciprocal titers against the A/Indo virus strain greater than or equal to (≥) 1:40. This outcome measure solely concerns the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2, and Naïve Placebo-A/turkey H5N1-Formulation 3 groups.|At Day 0, Day 10, Day 42, Day 182, Day 549, and Day 559|The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.||Subjects|||Number
770703|NCT00719043|Secondary|Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain.|A seroprotected subject was defined as a vaccinated subject with HI antibody reciprocal titers against the A/Indo virus strain greater than or equal to (≥) 1:40. This outcome measure solely concerns the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups.|At Day 0, Day 10, Day 42, Day 182 and Day 549|The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.||Subjects|||Number
770704|NCT00719043|Secondary|Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain.|HI antibody titers against the A/Indo virus strain were expressed as geometric mean titers (GMTs). This outcome measure solely concerns the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2, and Naïve Placebo-A/turkey H5N1-Formulation 3 groups.|At Days 0, 10, 42, 182, 549 and 559|The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.||Titers||95% Confidence Interval|Geometric Mean
770705|NCT00719043|Secondary|Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain.|HI antibody titers against the A/Indo virus strain were expressed as geometric mean titers (GMTs). This outcome measure solely concerns the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups.|At Days 0, 10, 42, 182 and 549|The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.||Titers||95% Confidence Interval|Geometric Mean
770706|NCT00719043|Secondary|Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain|A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome measure concerns solely the Naïve Placebo-A/turkey H5N1-Formulation 3 Group.|At Days 0, 182, 192, 224, 549, 559, 591 and 729|The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.||Subjects|||Number
770707|NCT00719043|Secondary|Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain|A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome measure concerns solely the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4, and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.|At Days 0, 182, 549, 559, 591 and 729|The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.||Subjects|||Number
770708|NCT00719043|Secondary|Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain.|A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome measure concerns solely the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups.|At Days 0, 182,192, 224, 549 and 729|The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.||Subjects|||Number
770758|NCT00719329|Primary|Colonization at Day 1 Swab|Was the swab collected on the day 1 visit (usually within 24 hours of birth) positive for any organism? If so, this is defined as positive.|First week of life|Intention to Treat||Participants|||Number
770710|NCT00719043|Secondary|Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain.|HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome measure concerns solely the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4, and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.|At Days 0, 182, 549, 559, 591 and 729|The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.||Titers||95% Confidence Interval|Geometric Mean
770711|NCT00719043|Secondary|Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain.|HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome measure concerns solely the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups.|At Days 0, 182,192, 224, 549 and 729|The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.||Titers||95% Confidence Interval|Geometric Mean
770712|NCT00719043|Secondary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. Pre-vaccination for this outcome measure corresponds to Day 182. This outcome measure solely concerns subjects in the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo, Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo, and Naïve Placebo-A/turkey H5N1-Formulation 3 groups.|At Day 224|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.||Subjects|||Number
770713|NCT00719043|Secondary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. Pre-vaccination for this outcome measure corresponds to Day 549. This outcome concerns solely subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.|At Day 591|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.||Subjects|||Number
770714|NCT00719043|Primary|Number of Subjects With Serious Adverse Events (SAEs)|A SAE was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as an occurrence of an SAE, regardless its relationship to vaccination.|From Day 0 to Day 909|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.||Subjects|||Number
770715|NCT00719043|Primary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as any occurrence of an unsolicited AE in a subject, regardless of intensity grade or relation to vaccination.|Within the 43-day (Days 0-42) post-vaccination periods|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.||Subjects|||Number
770716|NCT00719043|Primary|Number of Subjects With Medically-attended Adverse Events (MAEs)|MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s).|From Day 0 to Day 909|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.||Subjects|||Number
770717|NCT00719043|Primary|Number of Subjects With Solicited General Symptoms|Solicited general symptoms assessed were fatigue, headache, joint pain at other locations (joint pain), muscle aches, shivering, sweating and fever. Any was defined as an occurrence of the specified solicited general symptom, irrespective of its intensity or relationship to vaccination. Any fever was defined as oral temperature higher than or equal to (≥) 38.0 degrees Celsius (°C).|Within the 7-day (Days 0-6) post vaccination periods|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.||Subjects|||Number
770718|NCT00719043|Primary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any was defined as an occurrence of the specified solicited local symptom regardless of its intensity.|Within the 7-day (Days 0-6) post vaccination periods|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.||Subjects|||Number
770759|NCT00719355|Secondary|Onset of Claudication Pain During Constant Work Rate Treadmill Test|Perceived pain onset was recorded during the constant workrate test using the Borg ratio scale. Patient rated their pain from 0-10. Time elapased on the treadmill (minutes) at the onset of pain was recorded.|At 24 weeks|Data were analyzed on all patients with at least 1 follow up constant workrate treadmill test.||minutes||Standard Deviation|Mean
770719|NCT00719043|Primary|Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.|A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome concerns solely subjects in the Naïve Placebo-A/turkey H5N1-Formulation 3 Group.|At Days 182 and 192|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.||Subjects|||Number
770720|NCT00719043|Primary|Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.|A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome concerns solely subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.|At Days 549 and 559|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.||Subjects|||Number
770721|NCT00719043|Secondary|Geometric Mean Fold Rise (GMFR) as Regards Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain|GMFR was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the baseline reciprocal HI titer. Baseline for this outcome measure corresponds to Day 549. This outcome measure solely concerns subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 and Naïve Placebo-A/turkey H5N1-Formulation 3 groups.|At Day 559|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.||Fold increase||95% Confidence Interval|Geometric Mean
770722|NCT00719043|Secondary|Geometric Mean Fold Rise (GMFR) as Regards Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain|GMFR was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the baseline reciprocal HI titer. Baseline for this outcome measure corresponds to Day 182. This outcome measure solely concerns subjects in the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo, Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo, and Naïve Placebo-A/turkey H5N1-Formulation 3 groups.|At Days 192 and 224|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.||Fold increase||95% Confidence Interval|Geometric Mean
770723|NCT00719043|Secondary|Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.|A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome concerns solely subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.|At Day 224|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.||Subjects|||Number
770724|NCT00719043|Secondary|Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.|A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome concerns solely subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.|At Day 591|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.||Subjects|||Number
770725|NCT00719043|Secondary|Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.|A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome measure solely concerns subjects in the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups.|At Days 182 and 192|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.||Subjects|||Number
770726|NCT00719043|Secondary|Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey Virus Strain.|HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome measure solely concerns subjects in the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups.|At Days 182 and 192|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.||Titers||95% Confidence Interval|Geometric Mean
770727|NCT00719043|Secondary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. Pre-vaccination for this outcome measure corresponds to Day 182. This outcome measure solely concerns subjects in the Naïve Placebo-A/turkey H5N1-Formulation 3 Group.|At Day 192|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.||Subjects|||Number
778137|NCT00774163|Primary|Serum ALT in Males||Day 5|limited to males||units per liter (U/L)||Standard Deviation|Mean
770728|NCT00719043|Primary|Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain.|HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome concerns solely subjects in the Naïve Placebo-A/turkey H5N1-Formulation 3 Group.|At Days 182 and 192|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.||Titers||95% Confidence Interval|Geometric Mean
770729|NCT00719043|Primary|Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain.|HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome concerns solely subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.|At Days 549 and 559|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.||Titers||95% Confidence Interval|Geometric Mean
770730|NCT00719043|Primary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. Pre-vaccination for this outcome measure corresponds to Day 182. This outcome concerns solely subjects in the Naïve Placebo-A/turkey H5N1-Formulation 3 Group|At Day 192|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.||Subjects|||Number
770731|NCT00719043|Primary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. Pre-vaccination for this outcome measure corresponds to Day 549. This outcome concerns solely subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.|At Day 559|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.||Subjects|||Number
770732|NCT00719134|Secondary|Pain Free at 2 Hours After Treatment|A secondary measure of attack outcome was based on categorical classification of the pain freedom (pain score = 0) 2.5 hours after onset of headache.|2 hours after treatment|For the secondary endpoint, the proportion of patients who were free from pain 2 hours after treatment, we used a mixed-effects logistic regression model to analyze the individual dichotomous outcomes.||percent of patients pain free||95% Confidence Interval|Number
770733|NCT00719134|Primary|Change in Headache Intensity|The primary outcome measure was the change in headache between the baseline pain score recorded 30 min after the onset of headache and the pain score recorded 2 hours later as measured on a visual analog scale ranging from 0 (no pain) to 10 (worst pain imaginable).|2 hours after treatment|For the primary endpoint, change in headache intensity from baseline to 2 hours after treatment, we used generalized linear mixed models with a normal random component and a logarithmic link function to analyze the pain scores.||percent change||95% Confidence Interval|Mean
770734|NCT00719160|Secondary|Gastric pH|"The American Heritage Dictionary defines pH as a measure of the acidity or alkalinity of a solution, numerically equal to 7 for neutral solutions, increasing with increasing alkalinity and decreasing with increasing acidity. The pH scale commonly in use ranges from 0 to 14. The normal pH range for stomach acid is between 1.5 and 3.5."|Day 5 of a high protein diet|||units on a scale of pH||Standard Error|Mean
770735|NCT00719160|Primary|Percent Change in Intestinal Calcium Absorption|This is completed by measuring the amount of calcium absorbed by utilizing dual stable calcium isotopes. It was hypothesized that we would see a percent decrease as a result of the proton pump inhibitor. Previous published data indicated a decline in calcium absorption of 6.6 +/- 5.5% when gastric pH is blocked.|Day 5 of a high protein diet|||percentage of calcium absorption||Standard Error|Mean
770741|NCT00719212|Secondary|Progression-free Survival (PFS) Investigator Assessment - Interval From Registration to Disease Progression or Death Due to Any Cause - According to RECIST and CA 125|"A patient may have been declared to have progressive disease on the basis of radiological measuremt of tumor lesions assessmt or CA125 evaluation (tumor measuremts taking precedence).Radiological progression was defined as per the RECIST guidelines (Therasse et al, JNCI2000) as at least 20% increase in the sum of the longest diameters of target lesions(ref the smallest sum of the longest diam recorded since the treatmt started or since the appearance of at least 1 new lesion).Serum CA125 progression was defined, according to the 2005 GCIG def: pts with:
Elevated CA125 pretreatmt and normalization of CA125 has to show evidence of CA125≥ 2 times the upper normal limit on 2 occasions at least 1 wk apart OR
Elevated CA125 pretreatmt which never normalized must show evidence of CA125≥ 2 times the nadir value on 2 occasions at least 1 wk apart OR
CA125 in the normal range pretreatmt had to show evidence of CA125 ≥ 2 times the upper normal limit on 2 occasions at least 1 wk apart"|Every 9 (+/- 1 ) weeks during study treatment until documentation of progression or end of study treatment + confirmation PR or CR no less than 4 weeks after initial documentation of response|Intent To Treat||months||95% Confidence Interval|Median
770742|NCT00719212|Secondary|Time To Marker Progression (TTMP) Investigator Assessment - Interval Form the Date of Registration to the Date of Disease Progression as Per GCIG 2005 Definition of CA 125 Progression.|"The GCIG criteria (November 2005) were used to define progressive disease, based on serum CA 125 levels, as follows:
Patients with elevated CA 125 pretreatment and normalization of CA 125 needed to show evidence of CA 125 greater than, or equal to, two times the ULN on two occasions at least 1 week apart or
Patients with elevated CA 125 pretreatment, which never normalizes needed to show evidence of CA 125 greater than, or equal to, two times the nadir value on two occasions at least 1 week apart or
Patients with CA 125 in the normal range pretreatment needed to show evidence of CA 125 greater than, or equal to, two times the ULN on two occasions at least 1 week apart."|Day 1 of each cycle|Intent To Treat||months||95% Confidence Interval|Median
770743|NCT00719212|Secondary|Overall Survival (OS) Investigator Assessment|Interval between the date of registration and the date of death|Day 1 of each cycle during study treatment + follow-up every 6 months for the first 3 years in the study or until death whichever occurs first|Intent To Treat||months||95% Confidence Interval|Median
770744|NCT00719212|Secondary|Clinical Benefit Rate (CBR) Investigator Assessmt % of Patients in the gp Who Achieve a Complete Response-CR,Partial Response-PR or Stable Disease-SD for 16wks From Registrat° Considering the Global Response Combining RECIST Criteria and CA125 Assessmts|"RECIST(v1.0):
CR:disappearance of all target les°&non-target les°&normalization of tumor marker level
PR:at least 30% decrease in the sum of the LD of target les°-ref the baseline sum LD OR CR for target les°&incomplete resp/SD for non target les°
SD:insufficient shrinkage for PR or increase for PD-ref the smallest sum LD since ttmt started or Persistence of one/more non-target les°or/&maintenance of tumor marker level above the normal
CA125 level:
PR:elev of CA125 at baseline PR if a ≥ 50% decrease compared to baseline value observed on 2 consec assessmts drawn at least 1 wk apart
CR:elev of CA125 at baseline CR 2 CA125 below ULN observed on 2 consec assessmts drawn at least 1 wk apart
SD:neither CR/PR nor PD
Best overall resp of :
CR:if CR per RECIST & per CA125
PR:if CR per RECIST & PR per CA125 OR CR per RECIST and SD per CA125 with elev CA125 at baseline OR PR per RECIST & CR/PR or SD per CA125
SD:other cases not qualifying for progression-at least 24 wks"|At 16 weeks from registration|Intent To Treat||percentage of patients||95% Confidence Interval|Number
770745|NCT00719212|Primary|Objective Response Rate (ORR) Independent Radiology Committee % of Patients in the Group Who Achieve a Complete or Partial Response According to RECIST Criteria and GCIG CA 125 Response Criteria.|"RECIST(v1.0):CR:disappearance of all target lesions or disappearance of all nontarget lesions & normalization of tumor marker level/•PR:at least 30% decrease in the sum of the longest diam(LD) of target les° taking as ref the baseline sum LD OR CR for target les° & incomplete response/SD for nontarget les°.
CR & PR to be confirmed no less than 4 wks after initial doc of response.The def of the resp acc to serum CA125 level was as per GCIGCA125 criteria:
PR:elevated CA125 at baseline PR considered if a ≥ 50% decrease compared to baseline value was observed on 2 consecutive assessmts drawn at least 1 wk apart
CR:elevated CA125 at baseline CR was def with 2 CA125 values below ULN observed on 2 consecutive assessmts drawn at least 1 wk apart A pt was considered to have a best overall resp of:CR:if CR as per RECIST & CA125 /-PR: if CR as per RECIST & PR as per CA125 OR CR as per RECIST and SD as per CA125 with elevated CA125 at baseline OR PR as per RECIST & CR/PR or SD as per CA125"|Radiological Tumor assessment: Every 9 (+/- 1 ) weeks during study treatment until documentation of progression or end of study treatment + confirmation PR or CR no less than 4 weeks after initial documentation of response + CA 125: Day 1 of each cycle|Intent To Treat||percentage of patients||95% Confidence Interval|Number
770746|NCT00719212|Secondary|Time To Progression (TTP) Investigator Assessment|Interval from the date of registration to the date of disease progression Investigator assessment As per RECIST (v1.0), disease progression represented an increase of at least 20% in the sum of the longest diameter (SLD) of target lesions, taking as reference the smallest SLD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|Every 9 (+/- 1 ) weeks during study treatment until documentation of progression or end of study treatment + confirmation PR or CR no less than 4 weeks after initial documentation of response|Intent To Treat||months||95% Confidence Interval|Median
770747|NCT00719212|Primary|Objective Response Rate (ORR) Investigator Assessment: % of Patients in the Group Who Achieve a Complete Response(CR) or Partial Response(PR) According to RECIST Criteria and GCIG CA125 Response Criteria. - Assessments of the Response by the Investigators|"RECIST(v1.0):CR:disappearance of all target lesions or disappearance of all nontarget lesions & normalization of tumor marker level/•PR:at least 30% decrease in the sum of the longest diam(LD) of target les° taking as ref the baseline sum LD OR CR for target les° & incomplete response/SD for nontarget les°.
CR & PR to be confirmed no less than 4 wks after initial doc of response.The def of the resp acc to serum CA125 level was as per GCIGCA125 criteria:
PR:elevated CA125 at baseline PR considered if a ≥ 50% decrease compared to baseline value was observed on 2 consecutive assessmts drawn at least 1 wk apart
CR:elevated CA125 at baseline CR was def with 2 CA125 values below ULN observed on 2 consecutive assessmts drawn at least 1 wk apart A pt was considered to have a best overall resp of:CR:if CR as per RECIST & CA125 /-PR: if CR as per RECIST & PR as per CA125 OR CR as per RECIST and SD as per CA125 with elevated CA125 at baseline OR PR as per RECIST & CR/PR or SD as per CA125"|Radiological Tumor assessment: Every 9 (+/- 1 ) weeks during study treatment until documentation of progression or end of study treatment + confirmation PR or CR no less than 4 weeks after initial documentation of response + CA 125: Day 1 of each cycle|Intent To Treat||percentage of patients||95% Confidence Interval|Number
770748|NCT00719264|Secondary|Duration of Exposure of RAD001 in Participants Randomized to the Treatment Combination of RAD001 and Bevacizumab|This outcome measure was assessed continuously.|From the date of the first participant treated until the last patient discontinued the study treatment + 28 days|Safety Set: The safety set included all participants who received at least one dose of study drug (everolimus, bevacizumab or IFN) and had a valid post-baseline assessment. No AE or occurrence of death, noted at assessment, constitutes a valid post-baseline safety assessment.||weeks||Full Range|Median
770760|NCT00719355|Primary|Length of Exercise Duration on the Treadmill Constant Work Rate Exercise Test|Patients walked on the CWR test at 85% of his/her peak VO2 on the baseline progressive treadmill test. Since the polewalking group was older than the walking group, subject age was entered into the analysis as a co-variate. Intent-to-treat (ITT) analyses were used. The last measurement taken for all subjects with at least one follow-up test was carried forward (n=97).|Baseline and 24 weeks|Data were analyzed on patients with at least 1 follow-up treadmill test from baseline.||minutes||Standard Deviation|Mean
770749|NCT00719264|Secondary|Time to Definitive Deterioration of the Global Health Status and the Physical Functioning (PF) Subscale Scores of the European Organization for the Research and Treatment of Cancer (EORTC)-Core Quality of Life Questionnaire (QLQ-C30) by at Least 10%|The EORTC QLQ-C30 contains 30 items. These include five functional scales (physical, role, emotional, social and cognitive functioning), three symptom scales (fatigue, pain, nausea, and vomiting), a global health status/QoL scale, and six single items (dyspnea, diarrhea, constipation, anorexia, insomnia and financial impact). The PF subscale consists of 5 questions each scored from 1 (not at all) to 4 (very much). The score for the PF subscale and global health status range from 0 to 100, with a higher score representing a high level of functioning/high quality of life. Definitive deterioration by at least 10% is defined as a decrease in score by at least 10% compared to baseline, with no later increase above this threshold observed during the course of the study. A single measure reporting a decrease of at least 10% is considered definitive only if it is the last one available for the participant.|Time from randomization to the date of definitive deterioration (defined as no later increase above the threshold observed during the study), or date of last assessment, reported between date of first participant randomized until 31Dec2011|Full Analysis Set: This set consists of all randomized participants.||Months||95% Confidence Interval|Median
770750|NCT00719264|Secondary|Time to Definitive Deterioration of the Functional Assessment of Cancer Therapy Kidney Symptom Index, Disease Related Symptoms (FKSI-DRS) Risk Score by at Least 2 Score Units|The analysis of this outcome measure was based on the FKSI-DRS scale which is a validated disease-related symptom index containing 9 items that measure symptoms predominantly related to kidney cancer. Each item is scored on a 5-point scale (0 = not at all; 4 = very much). If at least 5 of the 9 questions have been answered, the FKSI-DRS total score is calculated by subtracting nine times the mean of the scores of the answered items from 36. Participants with less than 5 out of the 9 questions answered will have a missing FKSI-DRS total score. The FKSI-DRS total score ranges from 0 (most severe symptoms) to 36 (no symptoms). Definitive deterioration is defined as a decrease by at least 2 units compared to baseline, with no later increase above this threshold observed during the study. A single measure reporting a decrease of at least 2 units was considered definitive only if it is the last one available for the participant.|Time from randomization to the date of definitive deterioration (defined as no later increase above the threshold observed during the study), or date of last assessment, reported between date of first patient randomized until 31Dec2011|Full Analysis Set: This set consists of all randomized participants.||Months||95% Confidence Interval|Median
770751|NCT00719264|Secondary|Number of Participants Who Experienced Adverse Events (AEs), Serious Adverse Events and Deaths|Participants were monitored for adverse events, serious adverse events and deaths throughout the study. Participants were assessed continuously at each 28-day cycle.|From the first participant randomized until the last patient discontinued the study treatment + 28 days|Safety Set: The safety set included all participants who received at least one dose of study drug (everolimus, bevacizumab or IFN) and had a valid post-baseline assessment. No AE or occurrence of death, noted at assessment, constitutes a valid post-baseline safety assessment.||Participants|||Number
770752|NCT00719264|Secondary|Response Duration Differences in Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab|The duration of response, applied only to participants with best overall response at CR or PR, is defined as the number of days between the date of first documented response (CR or PR) and the date of the event: radiological progression as per central review or death due to underlying cancer, whichever occurs first. If no event, participant is censored at the last adequate assessment.|Time from first documented response date of radiological progressive disease as per independent central review, death due to underlying cancer, or last tumor assessment, reported between date of first participant randomized until 31Dec2011, cut-off date.|A subset of participants from the full analysis set were analyzed. The full analysis set consists of all randomized participants. the subset includes participants who were complete responders or partial responders.||Months||95% Confidence Interval|Median
770753|NCT00719264|Secondary|Best Overall Response in Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab|Overall response is defined as the number of participants having achieved confirmed Complete Response (CR) + Partial Response (PR). Confirmed CR = at least two determinations of CR at least 4 weeks apart before progression. Confirmed PR = at least two determinations of PR or better at least 4 weeks apart before progression. CR required a disappearance of all target and non-target lesions. PR required at least a 30% decrease in the sum of the longest diameters of all target lesions, taking as a reference the baseline sum of the longest diameters. Disease progression was defined as: 1) a 20% increase in the sum of the longest diameter of all target lesions, taking as reference the smallest sum of the longest diameters of all target lesions recorded at or after baseline or 2) the appearance of a new lesions or 3) the unequivocal progression of non-target lesions overall.|Time from first participant randomized until 31Dec2011, cutoff date.|Full Analysis Set: This set consists of all randomized participants.||Number of participants|||Number
770754|NCT00719264|Secondary|Overall Survival (OS) Treatment Effect in Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab|Overall survival (OS) was defined as the time of randomization to the date of death due to any cause.|Time from randomization to the date of death from any cause, reported between date of first participant randomized and up to 2 years after the last participant randomized (data cutoff: 30Aug2012)|Full Analysis Set: This set consists of all randomized participants.||Months||95% Confidence Interval|Median
770755|NCT00719264|Primary|Progression-free Survival (PFS) of Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab|Tumor response and disease progression were assessed using response evaluation criteria in solid tumors (RECIST), version 1.0. All target and non-target lesions identified at baseline were assessed using the same method, CT scan with contrast or MRI with contrast, throughout the trial. All scans were reviewed by independent, central radiology. Disease progression was defined as: 1) a 20% increase in the sum of the longest diameter of all target lesions, taking as reference the smallest sum of the longest diameters of all target lesions recorded at or after baseline or 2) the appearance of a new lesions or 3) the unequivocal progression of non-target lesions overall.|Time from randomization to the date of radiological progressive disease as per independent central review, death from any cause, or last tumor assessment, reported between date of first participant randomized until 31Dec2011, cutoff date.|Full Analysis Set: This set consists of all randomized participants.||Months||95% Confidence Interval|Median
770761|NCT00719472|Secondary|Percentage of Patients Who Had Undetectable Levels of CD19+ Lymphocytes at Cycle 2 and Either Cycle 6 or 8 (Last Cycle)|Serum samples for measurement of CD19+ lymphocytes were taken pre-dose (within 15 minutes before rituximab infusion). CD19+ lymphocyte counts were measured by flow cytometry using a fluorescent-activated cell sorter (FACS).|Day 1 of Cycle 2 and either Cycle 6 or 8 (last cycle)|Per-protocol evaluable population: All patients who received rituximab by faster infusion in Cycle 2 and who did not experience a Grade 3 or 4 infusion-related reaction during the rituximab infusion given at the standard rate during Cycle 1. Only patients with pre-dose CD19+ lymphocyte counts at each time point were included in the analyses.||Percentage of participants|||Number
770762|NCT00719472|Secondary|Maximum Serum Concentration (Cmax) of Rituximab Post-dose at the First Alternative Dosing Rate (Cycle 2) and the Last Cycle (Either Cycle 6 or 8)|Serum samples for rituximab pharmacokinetic analysis were taken pre-dose (within 15 minutes before rituximab infusion) and post-dose (within 15 minutes after the end of the rituximab infusion) after the first faster infusion (Cycle 2) and after the last infusion (either Cycle 6 or 8). An enzyme-linked immunosorbent assay (ELISA) was used to measure rituximab levels in the serum samples.|Day 1 of Cycles 2 and either 6 or 8 (last cycle)|Pharmacokinetic evaluable population: All patients who received at least 1 infusion of rituximab and had rituximab concentration data.||µg/mL||Standard Deviation|Mean
770763|NCT00719472|Secondary|Duration of Rituximab Infusion Including Dose Interruption Times|The median duration of the rituximab infusion on Day 1 of each cycle, including the duration of dose interruptions, is reported.|Day 1 of each of Cycles 1 to 6 or 8|Per-protocol evaluable population: All patients who received rituximab by faster infusion in Cycle 2 and who did not experience a Grade 3 or 4 infusion-related reaction during the rituximab infusion given at the standard rate during Cycle 1.||Minutes||Inter-Quartile Range|Median
770764|NCT00719472|Secondary|Percentage of Patients Who Had an Adverse Event of Any Grade or Seriousness During Cycle 2 Through Cycle 6 or 8 (End of Study)||Cycle 2 through Cycle 6 or 8 (end of study)|Per-protocol evaluable population: All patients who received rituximab by faster infusion in Cycle 2 and who did not experience a Grade 3 or 4 infusion-related reaction during the rituximab infusion given at the standard rate during Cycle 1.||Percentage of participants|||Number
770765|NCT00719472|Secondary|Percentage of Patients Who Had an Adverse Event of Any Grade or Seriousness During Cycle 1||Cycle 1|Intent-to-treat (ITT) population: All patients who received at least 1 dose of rituximab regardless of infusion rate.||Percentage of participants|||Number
770766|NCT00719472|Primary|Percentage of Patients Who Developed Grade 3 or 4 Infusion-related Reactions (IRR) Resulting From Faster Infusion of Rituximab During Days 1 and 2 of Cycle 2|The percentage of patients who developed Grade 3 or 4 IRRs resulting from faster infusion of rituximab at Cycle 2 was assessed in patients who had previously received rituximab at the standard infusion rate without experiencing a Grade 3 or 4 IRR at Cycle 1. IRRs were a predefined list of Medical Dictionary for Regulatory Activities (MedDRA) terms for infusion-related adverse events occurring on the day of and/or the day after rituximab infusion. The list of IRR terms was compiled based on IRRs observed in the present and previous studies in which rituximab was infused at the standard rate.|Days 1 and 2 of Cycle 2|Per-protocol evaluable population: All patients who received rituximab by faster infusion in Cycle 2 and who did not experience a Grade 3 or 4 infusion-related reaction during the rituximab infusion given at the standard rate during Cycle 1.||Percentage of participants||95% Confidence Interval|Number
770767|NCT00719537|Primary|Incidence of Preeclampsia|Number of Participants with preeclampsia in second and third trimester of pregnancy.|second and third trimester of pregnancy|1 Participant withdrawn in aspirin and placebo group, one participant lost to followup in aspirin and progesterone group.||Participants|||Count of Participants
770768|NCT00719563|Secondary|Change From Baseline to Week 4 in the General Subscale of the MFSI-SF for Minority Populations|"Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) general subscale is a six-item subscale to measure the subjective experience of fatigue. The items include feeling pooped, worn out, fatigued, sluggish, run down and tired. Answers are on a 5-point scale, ranging from 0 (not at all) to 4 (extremely). The subscale scores were the sum of all six items. The scores were converted to a 100-point scale, with higher numbers indicating less fatigue. Change from baseline to week 4 was calculated by subtracting the baseline scores from the scores at week 4."|Baseline and Week 4|The analysis was not able to be done due to the low numbers of minorities accrued.|||||
770769|NCT00719563|Secondary|Average Change From Baseline to Week 8 in Fatigue for Those Who Perceive a Change of +2 and +3|Changes in fatigue as measured using subscales of MFSI-SF, the interference scale of the BFI and the linear analogue scale fatigue question were compared between arms for those participants who express a perceived change in fatigue via the global impression score of a +2 (moderately better) and +3 (very much better).|Baseline and Week 8|Includes all participants who completed both baseline and week 8 assessments with a perceived change in fatigue via the global impression score of a +2 and +3 at week 8.||units on a scale||Standard Deviation|Mean
770770|NCT00719563|Secondary|Average Change From Baseline to Week 4 in Fatigue for Those Who Perceive a Change of +2 and +3|Changes in fatigue as measured using subscales of MFSI-SF, the interference scale of the BFI and the linear analogue scale (LASA) fatigue question were compared between arms for those participants who express a perceived change in fatigue via the global impression score of a +2 (moderately better) and +3 (very much better).|Baseline and Week 4|Includes all participants who completed both baseline and week 4 assessments with a perceived change in fatigue via the global impression score of a +2 and +3 at week 4.||units on a scale||Standard Deviation|Mean
770771|NCT00719563|Secondary|Change From Baseline to Week 8 for the Impact on Stress as Measured by Perceived Stress Scale (PSS)|PSS consist of 14 items that assess the impact on stress in a 5-points scale (0=never, 1=almost never, 2=sometimes, 3=fairly often and 4=very often). The total scores were the sum of all 14 items. The scores were then transformed into a 100-point scale with higher numbers indication less stress. Change from baseline to week 8 was calculated by subtracting the baseline scores from the scores at week 8.|Baseline and Week 8|Includes all participants who completed both baseline and week 8 assessments.||units on a scale||Standard Deviation|Mean
770782|NCT00719680|Secondary|Number of Subjects With Clinically Significant Changes From Baseline to the Completion Visit in Viral Safety Markers|Viral safety markers included human immunodeficiency virus (HIV)-1, HIV-2, hepatitis A virus (HAV), HBV, HCV, and parvovirus B19.|At Week 1, and study completion (approximately 104 weeks)|The AT safety population comprised all subjects treated with the study medication during any study period.||participants|||Number
770772|NCT00719563|Secondary|Change From Baseline to Week 8 Vigor/Activity and Fatigue-inertia as Measured by POMS|Profile of Mood States (POMS) measures a variety of mood states including tension/anxiety, depression/dejection, anger/hostility, vigor/activity, fatigue/inertia and confusion/bewilderment. Each subscale consist of 5 items with a 5 points-scale (0=not at all, 1=a little, 2=moderately, 3=quite a bit and 4=extremely). The subscale scores were the sum of all five items. The scores were then transformed into a 100-point scale with higher numbers indicating less fatigue. Change from baseline to week 8 was calculated by subtracting the baseline scores from the scores at week 8.|Baseline and week 8|Includes all participants who completed both baseline and week 8 assessments.||units on a scale||Standard Deviation|Mean
770773|NCT00719563|Secondary|Change From Baseline to Week 8 Fatigue as Measured by the BFI and Linear Analogue Scale of Fatigue|Brief Fatigue Inventory (BFI) consist of 3 items that assess the severity of fatigue and 6 items that assess the impact of fatigue on daily functioning in a 10-points scale with 0 as no fatigue or does not interfere with daily functioning and 10 as bad fatigue or completely interferes. The scores for the six items were summed up to form a total interference score. The linear analogue scale of fatigue was a 10-points scale with 0 as no fatigue and 10 as bad fatigue. All scores were then transformed into 0 to 100 scale, with 100 as less fatigue/less interference. Change from baseline to week 8 was calculated by subtracting the baseline scores from the scores at week 8.|Baseline and Week 8|Includes all participants who completed both baseline and week 8 assessments.||units on a scale||Standard Deviation|Mean
770774|NCT00719563|Secondary|Change From Baseline to Week 8 in the Impact on General, Physical, Mental, and Emotional States and Vigor as Measured by Other Subscales of the MFSI-SF|Each MFSI-SF subscale consist of 6 items on a 5-point scale, ranging from 0 (not at all) to 4 (extremely). The subscale scores were the sum of all six items. The scores were then converted to a 100-point scale, with higher numbers indicating less fatigue. Change from baseline to week 8 was calculated by subtracting the baseline scores from the scores at week 8.|Baseline and week 8|Includes all participants who completed both baseline and week 8 assessments.||units on a scale||Standard Deviation|Mean
770775|NCT00719563|Secondary|Change From Baseline to Week 4 for the Impact on Stress as Measured by Perceived Stress Scale (PSS)|PSS consist of 14 items that assess the impact on stress in a 5-points scale (0=never, 1=almost never, 2=sometimes, 3=fairly often and 4=very often). The total scores were the sum of all 14 items. The scores were then transformed into a 100-point scale with higher numbers indication less stress. Change from baseline to week 4 was calculated by subtracting the baseline scores from the scores at week 4.|Baseline and Week 4|Includes all participants who completed both baseline and week 4 assessments.||units on a scale||Standard Deviation|Mean
770776|NCT00719563|Secondary|Change From Baseline to Week 4 Vigor/Activity and Fatigue-inertia as Measured by POMS|Profile of Mood States (POMS) measures a variety of mood states including tension/anxiety, depression/dejection, anger/hostility, vigor/activity, fatigue/inertia and confusion/bewilderment. Each subscale consist of 5 items with a 5 points-scale (0=not at all, 1=a little, 2=moderately, 3=quite a bit and 4=extremely). The subscale scores were the sum of all five items. The scores were then transformed into a 100-point scale with higher numbers indicating less fatigue. Change from baseline to week 4 was calculated by subtracting the baseline scores from the scores at week 4.|Baseline and Week 4|Includes all participants who completed both baseline and week 4 assessments.||units on a scale||Standard Deviation|Mean
770777|NCT00719563|Secondary|Change From Baseline to Week 4 Fatigue as Measured by the BFI and Linear Analogue Scale of Fatigue|Brief Fatigue Inventory (BFI) consist of 3 items that assess the severity of fatigue and 6 items that assess the impact of fatigue on daily functioning in a 10-points scale with 0 as no fatigue or does not interfere with daily functioning and 10 as bad fatigue or completely interferes. The scores for the six items were summed up to form a total interference score. The linear analogue scale of fatigue was a 10-points scale with 0 as no fatigue and 10 as bad fatigue. All scores were then transformed into 0 to 100 scale, with 100 as less fatigue/less interference. Change from baseline to week 4 was calculated by subtracting the baseline scores from the scores at week 4.|Baseline and Week 4|Includes all participants who completed both baseline and week 4 assessments.||units on a scale||Standard Deviation|Mean
770778|NCT00719563|Secondary|Change From Baseline to Week 4 in the Impact on Physical, Mental, and Emotional States and Vigor as Measured by Other Subscales of the MFSI-SF|Each MFSI-SF subscale consist of 6 items on a 5-point scale, ranging from 0 (not at all) to 4 (extremely). The subscale scores were the sum of all six items. The scores were then converted to a 100-point scale, with higher numbers indicating less fatigue. Change from baseline to week 4 was calculated by subtracting the baseline scores from the scores at week 4.|Baseline and Week 4|Includes all participants who completed both baseline and week 4 assessments.||units on a scale||Standard Deviation|Mean
770779|NCT00719563|Secondary|Number of Treatment Related Grade 2 to 3 Adverse Events >=1% Incidence|Adverse events were assessed by Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grading: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death.|Week 1 to Week 8|Includes all participants that reported at least one value after baseline.||participants|||Number
770780|NCT00719563|Primary|Change From Baseline to Week 4 in the General Subscale of the MFSI-SF|"Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) general subscale is a six-item subscale to measure the subjective experience of fatigue. The items include feeling pooped, worn out, fatigued, sluggish, run down and tired. Answers are on a 5-point scale, ranging from 0 (not at all) to 4 (extremely). The subscale scores were the sum of all six items. The scores were converted to a 100-point scale, with higher numbers indicating less fatigue. Change from baseline to week 4 was calculated by subtracting the baseline scores from the scores at week 4."|Baseline and week 4|Includes all participants who completed both baseline and week 4 assessments.||units on a scale||Standard Deviation|Mean
770781|NCT00719615|Primary|Number of Persons That Are Vitamin D Deficient in the Thyroid Nodule, Thyroid Cancer in Remission, and the Active Thyroid Cancer Groups.|We evaluated serum calcium,creatinine,albumin,and 25-hydroxyvitaminD(25-OH-D)in 42 thyroid nodule, 45 thyroid cancer in remission, & 24 active thyroid cancer patients. We also determined the number and percent of participants in each group that had vitamin D deficiency, defined as 25-OH-D < 30 ng/ml.|Within 12 months of enrollment in thyroid cancer collaborative registry (TCCR) database|"This study is a pilot study to provide preliminary data. Per protocol, we accrued 37% of the sample size needed for a fully powered study. Using the outcome the proportion of persons with vitamin D deficiency, a sample size of 160 subjects (64 nodule, 64 remission, and 32 active) would achieve an 80% power to detect an effect size of 0.25."||participants|||Number
770785|NCT00719680|Secondary|Number of Subjects Reporting Mild, Moderate, or Severe Local AEs|"In addition to the standard MedDRA System Organ Class (SOC) AE assignments, the category of 'local reactions' was defined to provide the possibility for a combined analysis of local reactions and included AEs of infusion site oedema, infusion site reaction, injection site pain, injection site rash, and injection site reaction.
Mild AE: Did not interfere with routine activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities."|For the duration of the study, up to approximately 104 weeks|The AT safety population comprised all subjects treated with the study medication during any study period.||participants|||Number
770786|NCT00719680|Secondary|Rate of Temporally Associated AEs Within 24 or 72 Hours of an Infusion|"The rate of AEs was the number of AEs over the number of infusions administered.
AEs were considered temporally associated if they occurred between the start of infusion and within 24 or 72 hours after the end of infusion."|Within 24 or 72 hours after each infusion|The AT safety population comprised all subjects treated with the study medication during any study period.||AEs per infusion|Participants||Number
770787|NCT00719680|Secondary|Number of Subjects With Any Temporally Associated Adverse Event (AE) Within 24 or 72 Hours After an Infusion|AEs were considered temporally associated if they occurred between the start of infusion and within 24 or 72 hours after the end of infusion.|Within 24 or 72 hours after each infusion|The AT safety population comprised all subjects treated with the study medication during any study period.||participants|||Number
770788|NCT00719680|Secondary|Relatedness and Severity of All AEs (Percentage of Total AEs)|"At least possibly related AEs included possibly related AEs, probably related AEs, and related AEs.
Mild AE: Did not interfere with routine activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities."|For the duration of the study, up to approximately 104 weeks|The AT safety population comprised all subjects treated with the study medication during any study period.||percentage of total AEs|Participants||Number
770789|NCT00719680|Secondary|Rate of All AEs by Relatedness and Severity|"The rate of AEs was the number of AEs over the number of infusions administered.
At least possibly related AEs included possibly related AEs, probably related AEs, and related AEs.
Mild AE: Did not interfere with routine activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities."|For the duration of the study, up to approximately 104 weeks|The All-Treated (AT) safety population comprised all subjects treated with the study medication during any study period.||AEs per infusion|Participants||Number
770790|NCT00719680|Secondary|Use of Antibiotics for Infection Prophylaxis and Treatment|Annualized rate of days with antibiotics for infection prophylaxis and treatment.|For the duration of the study, up to approximately 104 weeks|The ITT population comprised all subjects treated with study medication during any study period.||days per subject year|Participants||Number
770791|NCT00719680|Secondary|Annualized Rate of Hospitalization Due to Infection|The annualized rate was based on the total number of days of hospitalization due to infection and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.|For the duration of the study, up to approximately 104 weeks|The ITT population comprised all subjects treated with study medication during any study period.||days per subject year|Participants||Number
770792|NCT00719680|Secondary|Number of Days of Hospitalization Due to Infection||For the duration of the study, up to approximately 104 weeks|The ITT population comprised all subjects treated with study medication during any study period.||days||Standard Deviation|Mean
770793|NCT00719680|Secondary|Annualized Rate of Days Out of Work / School / Kindergarten / Day Care or Inability to Perform Normal Activities Due to Infection|The annualized rate was based on the total number of days out of work / school / kindergarten / day care or inability to perform normal activities due to infection, and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.|For the duration of the study, up to approximately 104 weeks|The ITT population comprised all subjects treated with study medication during any study period.||days per subject year|Participants||Number
770794|NCT00719680|Secondary|Number of Days Out of Work / School / Kindergarten / Day Care or Inability to Perform Normal Activities Due to Infection||For the duration of the study, up to approximately 104 weeks|The ITT population comprised all subjects treated with study medication during any study period.||days||Standard Deviation|Mean
770795|NCT00719680|Secondary|Trough Levels of Total Immunoglobulin G (IgG) Serum Concentrations|Mean of individual median total IgG trough concentration.|Before infusion at Weeks 1, 24, 48, 72, and 96|The ITT population comprised all subjects treated with study medication during any study period.||g/L||Standard Deviation|Mean
770796|NCT00719680|Primary|Annualized Rate of Serious Bacterial Infection (Per-Protocol Efficacy Population)|"The annualized rate was based on the total number of infections and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.
Acute serious bacterial infections included pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess."|For the duration of the study, up to approximately 104 weeks|The Per-Protocol Efficacy population comprised all subjects who completed at least 48 weeks of the efficacy period that started with the first IgPro20 dose in this study.||infections per subject year|Participants||Number
770797|NCT00719680|Secondary|Annualized Rate of Any Infection|The annualized rate was based on the total number of infections and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.|For the duration of the study, up to approximately 104 weeks|The ITT population comprised all subjects treated with study medication during any study period.||infections per subject year|Participants||Number
770798|NCT00719680|Primary|Annualized Rate of Serious Bacterial Infection (Intention-to-Treat Population)|"The annualized rate was based on the total number of infections and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.
Acute serious bacterial infections included pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess."|For the duration of the study, up to approximately 104 weeks|The Intention-to-Treat (ITT) population comprised all subjects treated with study medication during any study period.||infections per subject year|Participants||Number
770911|NCT00720499|Secondary|Individual FVC Measurements|"Individual FVC measurements [L] at each time point
The categories correspond to the planned times for FVC measurements on Day 29.
The presented means are adjusted."|1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h, 4h, 5h, 6h after drug administration on day 29|FAS||Litres||Standard Error|Mean
770799|NCT00719706|Secondary|Phosphorus MRS Scans on 4T Scanner|Whole brain total NTP levels as measured by a phosphorus MRS scan on the 4T scanner. The data could range from 0 - 1, with 0 representing the lowest NTP level and 1 representing the highest NTP level.|Baseline to 12 weeks|At baseline, the number of participants analyzed was the number entered into the imaging portion of the study. At endpoint, the number or participants analyzed is the last observation carried forward of the original 10 participants in each category.||units on a scale||Standard Deviation|Mean
770800|NCT00719706|Primary|Clinical Global Impression-Severity|"Scores could range from 0 - 7 units on a scale, with 0 representing the least severe (Normal, not at all ill) and 7 representing the most severe (Among the most extremely ill patients)."|Baseline to 15 weeks|At baseline, the number of participants analyzed was the number randomized into the study. At endpoint, the number or participants analyzed is the last observation carried forward of the original 20 participants.||units on a scale||Standard Deviation|Mean
770801|NCT00719706|Primary|The Young Mania Rating Scale|The scores could range from 0 - 60 units on a scale with 0 representing the least number of manic symptoms and 60 representing the most number of manic symptoms.|Baseline to 15 weeks|At baseline, the number of participants analyzed was the number randomized into the study. At endpoint, the number or participants analyzed is the last observation carried forward of the original 20 participants.||units on a scale||Standard Deviation|Mean
770802|NCT00719706|Primary|The Montgomery-Asberg Depression Rating Scale|Scores could range from 0 - 60 units on a scale with 0 representing the least number of depressive symptoms and 60 representing the most number of depressive symptoms.|Baseline to 15 weeks|At baseline, the number of participants analyzed was the number randomized into the study. At endpoint, the number or participants analyzed is the last observation carried forward of the original 20 participants.||units on a scale||Standard Deviation|Mean
770803|NCT00719706|Primary|The 25-Item Hamilton Depression Rating Scale.|Scores could range from 0 - 72 units on a scale, with 0 representing the least number of depressive symptoms and 72 representing the most number of depressive symptoms.|Baseline to 15 Weeks|At baseline, the number of participants analyzed was the number randomized into the study. At endpoint, the number or participants analyzed is the last observation carried forward of the original 20 participants.||units on a scale||Standard Deviation|Mean
770804|NCT00719732|Primary|Uncorrected Visual Acuity (UCVA)|Uncorrected Visual Acuity (UCVA) measured by means of logMAR at various distances (40 centimeters (cm), 50 cm, 60 cm, 70 cm, and 4 meters (m)). Visual Acuity (VA) is measured in logMAR. LogMAR is the “logarithm of the minimum angle of resolution”. A lower logMAR value indicates better visual acuity.|6 months|||logMAR||Standard Deviation|Mean
770805|NCT00719810|Secondary|Clinical Response in Patients With Methicillin-resistant Staphylococcus Aureus (MRSA)|A Cure was defined as resolution of baseline signs and symptoms, or improvement to an extent that no additional antibiotic treatment is necessary. Failure was defined as the need for additional antibiotics, either because of lack of efficacy after at least 2 days (i.e., 4 doses) of study treatment or because of treatment-related adverse events (AEs), and/or the need for surgical intervention greater than 48 hours after study entry.|14-21 days after the last dose of study drug|Clinically Evaluable (CE) patients (see previous definition) with MRSA isolated from screening culture of primary infection.||Participants|||Number
770806|NCT00719810|Primary|Clinical Response at Test of Cure (TOC) in the Clinically Evaluable (CE) Population|A Cure was defined as resolution of baseline signs and symptoms, or improvement to an extent that no additional antibiotic treatment is necessary. Failure was defined as the need for additional antibiotics, either because of lack of efficacy after at least 2 days (i.e., 4 doses) of study treatment or because of treatment-related adverse events (AEs), and/or the need for surgical intervention greater than 48 hours after study entry.|14-21 days after the last dose of study drug|The CE population included patients with a diagnosis of cSSSI who received at least 80% of study drug, had a test of cure (TOC) visit 14-21 days after the last dose of study drug, and who did not receive any concomitant, systemic antibacterial therapy with activity against the causative pathogen.||Participants|||Number
770807|NCT00719849|Secondary|Incidence of Relapse at 2 Years|"Number of participants with relapse at 2 years.
Patients with leukemia and lymphoma involving the BM and multiple myeloma will have this done by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients with lymphoma and myeloma will have radiology studies such as plain X-rays or CT scans and/or other studies such as blood tumor markers to document presence or absence of disease as clinically indicated."|2 years post transplant|||Participants|||Count of Participants
770808|NCT00719849|Secondary|Incidence of Relapse at 1 Year|"Number of participants with relapse at 1 year.
Patients with leukemia and lymphoma involving the BM and multiple myeloma will have this done by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients with lymphoma and myeloma will have radiology studies such as plain X-rays or CT scans and/or other studies such as blood tumor markers to document presence or absence of disease as clinically indicated."|1 year post transplant|||Participants|||Count of Participants
770809|NCT00719849|Secondary|Probability of Progression-free Survival at 2 Years|Kaplan-Meier estimate of the probability of progression-free survival at 2 years|2 years post transplant|||progression free survival probability||95% Confidence Interval|Number
770810|NCT00719849|Secondary|Probability of Progression-free Survival at 1 Year|Kaplan-Meier estimate of the probability of progression-free survival at 1 year|1 year post transplant|||progression free survival probability||95% Confidence Interval|Number
770811|NCT00719849|Secondary|Incidence of Clinically Significant Infections at 2 Years|Number of participants with clinically significant infections at 2 years|2 years post transplant|||Participants|||Count of Participants
770812|NCT00719849|Secondary|Incidence of Clinically Significant Infections at 1 Year|Number of participants with clinically significant infections at 1 year|1 year post transplant|||Participants|||Count of Participants
770813|NCT00719849|Secondary|Incidence of Clinically Significant Infections at 6 Months|Number of participants with clinically significant infections at 6 months|6 months post transplant|||Participants|||Count of Participants
770842|NCT00720057|Secondary|Total Pain Relief (TOTPAR)|Pain relief categorical rating scale - no relief (0), a little relief (1), some relief (2), a lot of relief (3), or complete relief (4) was used for all pain relief assessments postdose. Time weighted total pain relief (TOTPAR) was calculated by multiplying the pain relief score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values.|0-24 hours post dose|Efficacy analyses were based on ITT population (n=312).||units on a scale||Standard Deviation|Mean
770814|NCT00719849|Secondary|Incidence of Chronic Graft-versus-host-disease (GVHD) at 1 Year|"Number of participants with chronic graft-versus-host-disease (GVHD) at 1 year.
Clinical Limited cGVHD
Oral abnormalities consistent with cGVHD, a positive skin or lip biopsy, and no other manifestations of cGVHD.
Mild liver test abnormalities (alkaline phosphatase <2 x upper limit of normal, AST or ALT <3 x upper limit of normal and total bilirubin <1.6) with positive skin or lip biopsy, and no other manifestations of cGVHD.
Less than 6 papulosquamous plaques, macular-papular or lichenoid rash involving <20% of body surface area (BSA), dyspigmentation involving <20% BSA, or erythema involving <50% BSA, positive skin biopsy, and no other manifestations of cGVHD.
Ocular sicca (Schirmer’s test <5mm with no more than minimal ocular symptoms), positive skin or lip biopsy, and no other manifestations of cGVHD.
Vaginal or vulvar abnormalities with positive biopsy, and no other manifestations of cGVHD."|1 year post transplant|||Participants|||Count of Participants
770815|NCT00719849|Secondary|Incidence of Grade III-IV Acute Graft-versus-host-disease (GVHD) at Day 100|"Number of participants with Grade III-IV acute graft-versus-host-disease (GVHD) at day 100.
Acute GVHD Staging and Grading:
Overall grade 1: stage 1-2 skin, no liver or gut Overall grade 2: stage 3 skin or stage 1 liver or stage 1 gut Overall grade 3: stage 4 skin or stage 2-4 liver or stage 2-4 gut (without GVHD as a major contributing cause of death) Overall grade 4: stage 4 skin or stage 2-4 liver or stage 2-3 gut (with GVHD as a major contributing cause of death)"|Day 100 post transplant|||Participants|||Count of Participants
770816|NCT00719849|Secondary|Incidence of Grade II-IV Acute Graft-versus-host-disease (GVHD) at Day 100|"Number of participants with Grade II-IV acute graft-versus-host-disease (GVHD) at day 100.
Acute GVHD Staging and Grading:
Overall grade 1: stage 1-2 skin, no liver or gut Overall grade 2: stage 3 skin or stage 1 liver or stage 1 gut Overall grade 3: stage 4 skin or stage 2-4 liver or stage 2-4 gut (without GVHD as a major contributing cause of death) Overall grade 4: stage 4 skin or stage 2-4 liver or stage 2-3 gut (with GVHD as a major contributing cause of death)"|Day 100 post transplant|||Participants|||Count of Participants
770817|NCT00719849|Secondary|Incidence of Platelet Engraftment at 6 Months|Number of participants with platelet engraftment at 6 months|6 months post transplant|||Participants|||Count of Participants
770818|NCT00719849|Secondary|Incidence of Neutrophil Engraftment at Day 42|Number of participants with neutrophil engraftment at day 42|Day 42 post transplant|||Participants|||Count of Participants
770819|NCT00719849|Secondary|Chimerism|Count of participants who experienced dominance of one cord blood unit (defined by >or= 95% contribution of one cord blood unit to BM and all PB fractions -- CD3+, CD33+, CD56+, and CD19+) at 7 days, 14 days, 21 days, 28 days, 56 days, and 80 days, 6 months, 1 and 2 years post transplant.|7 days, 14 days, 21 days, 28 days, 56 days, and 80 days, 6 months, 1 and 2 years post transplant|||Participants|||Count of Participants
770820|NCT00719849|Secondary|Incidence of Non-relapse Mortality at 6 Months|Number of Participants with Non-relapse Mortality at 6 Months|6 months post transplant|||Participants|||Count of Participants
770821|NCT00719849|Secondary|Probability of Survival at 2 Years|Kaplan-Meier estimate of the probability of survival at 2 years|2 years post transplant|||survival probability||95% Confidence Interval|Number
770822|NCT00719849|Primary|Probability of Survival at 1 Year|Kaplan-Meier estimate of the probability of survival at 1 year|1 year post transplant|||survival probability||95% Confidence Interval|Number
770823|NCT00719862|Secondary|Change From Baseline on Direct Visual Nasal Exams at 14 Days|Examination of head and neck (scale: None, Mild, Moderate, Severe) for Epistaxis, Mucosal Edema, Nasal Discharge, Mucosal erythema, Mucosal Bleeding, and Crusting of mucosa. Nasal irratation was rated: 0 = None,Grade 1A = focal irritation, Grade 1B = superficial mucosal erosion, Grade 2 = moderate mucosal erosion, Grade 3 = ulceration, Grade 4 = septal perforation|baseline and 14 days|||Participants|||Number
770824|NCT00719862|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)at 14 Days|"A 28-item RQLQ was completed on Day 1 and Day 14 or Early temination. The RQLQ consists of 7 domains rated on a 7 point scale with 0 being not troubled by the allergy symptoms, and 6 being extremely troubled/all of the time.
Total overall score is not calculated by adding all subscales scores for an overall score. Domain score will be calculated from the mean score of all items in the domain. Overall score will be calculated from the mean score of all items."|baseline and 14 Days|||Units on a scale||Standard Deviation|Least Squares Mean
770825|NCT00719862|Secondary|Change From Baseline in 12-hour Reflective SSCS for the Entire 14-day Study Period Compared to Placebo (Am and PM Combined)|"Reflective secondary symptom scores (SSCS) (post-nasal drip, itchy eyes, cough and headacdhe) were assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible SSCS score is 24 per day.
Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate."|baseline and 14-days|||Refecltive secondary symptom score||Standard Deviation|Least Squares Mean
770826|NCT00719862|Secondary|Change From Baseline in 12 Hour Instantaneous Total Nasal Sytmptom Score (AM and PM Combined)at 14 Days|"instantaneous (subjects rate how they feel right now) total nasal symptom score consisting of runny nose, itchy nose, nasal congestion, and sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible score is 24 per day.
Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate."|baseline and 14-days|||total nasal symptom score||Standard Deviation|Least Squares Mean
770827|NCT00719862|Secondary|Mean Change From Baseline in Instantaneous Total Nasal Symptom Score (tNSS) (AM) for the Entire 14-day Study Period Compared to Placebo|"End of 24 hour dosing interval: This endpoint is change from baseline in instantaneous tNSS for the 14-day study period compared to placebo to observe if the duration of efficacy lasts 24 hours on a day to day basis. Instantaneous tNSS consists of runny nose, itchy nose, nasal congestion, and sneezing. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe.
Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and baseline as a covariate."|baseline and 14 days|||scores on a scale||Standard Deviation|Least Squares Mean
771009|NCT00721188|Primary|Maximum Observed Serum Concentration (Cmax)||Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.|||ug/dL||Standard Deviation|Mean
778138|NCT00774163|Primary|Serum Alanine Aminotransferase (ALT) in Female Participants||Day 5|limited to females||units per liter (U/L)||Standard Deviation|Mean
770828|NCT00719862|Primary|Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (AM and PM Combined)at 14 Days|"reflective total nasal symptom score consisting of runny nose, itchy nose, nasal congestion, and sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible score is 24 per day.
Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate."|baseline and 14 days|||scores on a scale||Standard Deviation|Least Squares Mean
770829|NCT00719901|Secondary|Toxicity as Assessed by the National Cancer Institute (NCI) CTCAE v 3.0 (Phase II)|Toxicity is defined as adverse events that are classified as either possibly, probably, or definitely related to study treatment. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns. In addition, we will review all toxicities data that is graded as 3, 4, or 5 and classified as either “unrelated or unlikely to be related” to study treatment in the event of an actual relationship developing. Adverse events and toxicities will be evaluated using all patients who have received any study treatment.|From baseline to up to 3 years|No participants proceeded to Phase II for evaluation.|||||
770830|NCT00719901|Secondary|Time to Treatment Failure (Phase II)|Time to treatment failure will be evaluated using the method of Kaplan-Meier.|Time from study entry to the date patients end treatment|No participants proceeded to Phase II for evaluation.|||||
770831|NCT00719901|Secondary|Overall Survival (Phase II)|The distribution of overall survival will be estimated using the method of Kaplan-Meier.|Time from registration to death due to any cause|No participants proceeded to Phase II for evaluation.|||||
770832|NCT00719901|Secondary|Time to Progression (Phase II)|The distribution of time to progression will be estimated using the method of Kaplan-Meier.|Time from registration to the time of progression|No participants proceeded to Phase II for evaluation.|||||
770833|NCT00719901|Secondary|Number of Patients Who Have at Least a Partial Response (Phase I)|In order to be classified as a hematologic response, confirmation of serum monoclonal protein, serum immunoglobulin free light chain (when primary determinant of response) and urine monoclonal protein (when primary determinant of response) results must be made by verification on two consecutive determinations.|From baseline to up to 3 years|||participants|||Number
770834|NCT00719901|Primary|Proportion of Patients Who Achieve a Partial Response or Better. (Phase II)|In order to be classified as a hematologic response, confirmation of serum monoclonal protein, serum immunoglobulin free light chain (when primary determinant of response) and urine monoclonal protein (when primary determinant of response) results must be made by verification on two consecutive determinations.|From baseline to up to 3 years|No participants proceeded to Phase II for evaluation.|||||
770835|NCT00719901|Primary|Number of Dose-limiting Toxicity (DLT) Incidents (Phase I)|DLT was defined as any events that is determined to be possibly, probably, or definitely related to the combination of bortezomib and GX15-070 (as determined by the investigator) and occurring during the first cycle of treatment, irrespective of whether the toxicity resolved. Hematologic DLT measures were assessed using the continuous variables as the outcome measures (primarily nadir and percent change from baseline values) as well as categorization via Common Terminology Criteria for Adverse Events (CTCAE) version 3 standard toxicity grading.|Up to 21 days of every first course|||Toxicity Incidents|||Number
770836|NCT00719914|Primary|Improvement in Percent Diameter Stenosis of the Culprit Artery Following the IC Bolus Administration of Eptifibatide vs. IC Placebo (Saline) as Assessed With Quantitative Coronary Angiography (QCA)||30 days|study terminated due to low enrollment|||||
770837|NCT00719953|Primary|Improvement of Cognitive Performance (Change From Baseline in Neuropsychological Computerized Test)|The computerized neuropsychological assessment software consists of seven separate tasks: symbol spotting, pattern identification, pattern recall, digit-symbol substitution, digits span forward, digits span backward and delayed pattern recall. Based on the results obtained in the single tasks, eight cognitive composite scores are calculated including focused attention, sustained attention, memory recognition & recall, visuospatial learning, spatial short term memory, executive functions and mental flexibility.The total score range is from 0 to 100 points(0 is worse, 100 is best).|Base line and 12 weeks|||Points on a scale||Standard Error|Mean
770838|NCT00720057|Secondary|Time to Onset of Effect|"Time to onset of effect is defined as the time to meaningful pain relief, provided that the subjects experienced both perceptible and meaningful pain relief. Perceptible pain relief was defined as when the subject first began to feel any pain-relieving effect from the investigational product. Meaningful pain relief was defined as when the subject felt the degree of pain relief was meaningful to them."|from postdose to onset of first perceptible and meaningful pain relief for up to 6 hours|Efficacy analyses are based on ITT population (n=312).||hours||Full Range|Median
770839|NCT00720057|Secondary|Global Assessment of the Investigational Product as a Pain Reliever|Categorical Scale: Poor (0), Fair (1), Good (2), Very Good (3), Excellent (4).|at 24 hours postdose or immediately before first use of rescue medication|Efficacy analyses are based on ITT population (n=312).||units on a scale||Standard Deviation|Mean
770840|NCT00720057|Secondary|Time to First Use of Rescue Medication|Time to first use of rescue medication was estimated using the Kaplan-Meier method and analyzed by a Log rank test stratified by trial site and baseline pain intensity (PI). The outcome measure is time to first use of rescue medication. The criteria are if adequate pain relief is not achieved, then subjects are permitted to take rescue medication.|postdose to first use of rescue medication|Efficacy analyses are based on ITT population (n=312).||hours||Full Range|Median
770841|NCT00720057|Secondary|Summed Pain Intensity Difference at Specific Time Intervals|Categorical pain intensity scale - no pain (0), mild pain (1), moderate pain (2), or severe pain (3) was used for all pain intensity assessments postdose. Time-weighted Sum Pain Intensity Difference (SPID) was calculated by multiplying the Pain Intensity Difference (PID) score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values for 0-6, 0-12, 0-16 hour intervals, respectively.|0-16 hours post dose|Efficacy analyses were based on ITT population (n=312).||units on a scale||Standard Deviation|Mean
770893|NCT00720499|Secondary|12-lead ECG QTcB Intervals|"12-lead ECG heart rate corrected QT interval, using Bazett method (QTcB), baseline and change from baseline at other time points in milliseconds.
Statistics for each planned time from baseline to day 29."|Baseline, then 10min, 1h after drug administration on day 1, 30min before and 10min after drug administration on day 15, in addition 1h after drug administration on day 29|TS||mS||Standard Deviation|Mean
770843|NCT00720057|Primary|Summed Pain Intensity Difference (SPID)|Categorical pain intensity scale - no pain (0), mild pain (1), moderate pain (2), or severe pain (3) was used for all pain intensity assessments postdose. Time-weighted Sum Pain Intensity Difference (SPID) was calculated by multiplying the Pain Intensity Difference (PID) score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values over 0-24 and 16-24 hours, respectively.|0 to 24 hours post dose|Randomized population is defined as all subjects who signed informed consent form, completed the screening period, and were randomized. The ITT population is defined as all subjects who were randomized and received at least one dose of the study treatment. Efficacy analyses are based on the ITT population (n=312).||units on a scale||Standard Deviation|Mean
770844|NCT00720083|Primary|Disease-free Survival|This study terminated early with 34 subjects accrued out of 170 planned, therefore no analyses were performed.|From randomization to date of failure (local, regional, or distant progression, or death) or last follow-up. Analysis occurs after 78 failures have been reported.||||||
770848|NCT00720109|Secondary|Overall EFS Rate for the Combined Cohort of Standard- and High-Risk Patients (Who Receive the Final Chosen Dose of Dasatinib)|An event is defined as: Induction failure, relapse at any site, secondary malignancy, or death.|From the time entry on study to first event or date of last follow-up, assessed up to 7 years|Included in the analysis are two patients who received the drug therapy but were not risk classified.||percentage of patients||90% Confidence Interval|Number
770849|NCT00720109|Secondary|Percent of Patients MRD Positive (MRD > 0.01%) at End of Consolidation|A 1-sample Z-test of proportions (alpha=5%, 1-sided test) will be used.|At end of consolidation (at 11 weeks)|Patients with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL).||Percentage of participants||90% Confidence Interval|Number
770850|NCT00720109|Secondary|Contribution of Dasatinib on Minimal Residual Disease (MRD) After Induction Therapy|Percent of patients MRD Positive (MRD > 0.01%) at End of Induction.|At the end of induction therapy (at 5 weeks)|Patients with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL).||Percentage of participants||90% Confidence Interval|Number
770851|NCT00720109|Primary|Feasibility and Toxicity of an Intensified Chemotherapeutic Regimen Incorporating Dasatinib for Treatment of Children and Adolescents With Ph+ ALL Assessed by Examining Adverse Events|Number of patients in safety cohort with dose limiting toxicity (DLT)(including treatment delay)|Weeks 3 through 23 of treatment (From week 3 Induction through Intensification Block 1)|Patients with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL)||Pts with DLTs|||Number
770852|NCT00720109|Primary|Event-Free Survival (EFS) of Patients With Standard-risk Disease Treated With Dasatinib in Combination With Intensified Chemotherapy|Event-Free Survival (EFS) curves will be constructed using the Kaplan-Meier life table method with standard errors computed using the method of Peto and Peto. A 1-sided 95% confidence interval for EFS will be constructed.|At 3 years|Patients with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL).||Percent probability||90% Confidence Interval|Number
770853|NCT00720122|Primary|Change in Spine Bone Density (g/cm^2)|Change in spine bone density over 6 months (6month data- baseline data). Bone density at the spine was assessed using dual energy x-ray absorptiometry at baseline and 6 months and the change in bone density over these 6 months was calculated.|Baseline and 6 months|The study participants analyzed were those that completed the first 6 months of the study and had a bone density performed at the baseline visit and then again at the 6 month visit as per protocol.||gm/cm^2||Standard Error|Mean
770854|NCT00720226|Secondary|Change in FEV1 (L)|Change in FEV1 (L) post-bronchodilator from baseline to 12 months. Analysis includes only participants with 5-35% emphysema at baseline.|Measured at Baseline and Month 12|Participants with 5-35% emphysema at baseline who had HRCT scans performed both at baseline and at 12 months.||L (BTPS)||Standard Deviation|Mean
770855|NCT00720226|Primary|Change in Percent Emphysema on CT Scan|Percent emphysema calculated as percent of CT voxels less than -950 HU measured at TLC. Analysis limited to patients with 5-35% emphysema on CT scan at baseline.|Change between baseline and month 12.|Participants with 5-35% emphysema on baseline CT scan||% Emphysema Whole Lung||Standard Deviation|Mean
770856|NCT00720278|Secondary|Change From Baseline on Direct Visual Nasal Exams|"Examination of head and neck (scale: None, Mild, Moderate, Severe) for Epistaxis, Mucosal Edema, Nasal Discharge, Mucosal erythema, Mucosal Bleeding, and Crusting of mucosa.
Nasal irratation was rated: 0 = None, Grade 1A = focal irritation, Grade 1B = superficial mucosal erosion, Grade 2 = moderate mucosal erosion, Grade 3 = ulceration, Grade 4 = septal perforation"|14 days|||Participants|||Number
770857|NCT00720278|Secondary|Change From Baseline to Day 14 in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Compared to Placebo in Patients 18 Years of Age and Older|"A 28-item RQLQ was completed on Day 1 and Day 14 or Early temination. The RQLQ consists of 7 domains rated on a 7 point scale with 0 being not troubled by the allergy symptoms, and 6 being extremely troubled/all of the time.
Domain score will be calculated from the mean score of all items in the domain. Overall score will be calculated from the mean score of all items."|baseline and 14 days|||28 item/7 domain RQLQ on 0-6 scale||Standard Deviation|Least Squares Mean
770875|NCT00720434|Secondary|Population Pharmacokinetics (PK) of PF-00868554|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|1, 2 and 6 hours post-dose on Day 1; 0 hour (pre-dose) on Day 7, 14, 21; 0 hour (pre-dose), 2, 6 hours post-dose on Day 28||||||
770858|NCT00720278|Secondary|Change From Baseline in the 12-hour Reflective Secondary Symptom Complex Score for the Entire 14-day Study Period Compared to Placebo|"Reflective secondary symptom scores (SSCS) (post-nasal drip, itchy eyes, cough and headache) were assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible SSCS score is 24 per day.
Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate."|baseline and 14 days|||Reflective secondary symptom score||Standard Deviation|Least Squares Mean
770859|NCT00720278|Secondary|Change From Baseline in Instantaneous Total Nasal Symptom Score for the Entire 14-day Study Period Compared to Placebo|"instantaneous (subjects rate how they feel right now) total nasal symptom score consisting of runny nose, itchy nose, nasal congestion, and sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible score is 24 per day.
Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate."|baseline and 14 Days|||total nasal symptom score||Standard Deviation|Least Squares Mean
770860|NCT00720278|Primary|Change From Baseline in 12-hour Reflective Total Nasal Symptom Score(rTNSS)for the Entire 14-day Study Period Compared to Placebo|"rTNSS consisting of runny nose, itchy nose, nasal congestion, and sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. (maximum 12 points per assessment.) Total possible score is 24 per day.
Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and baseline as a covariate."|baseline and 14 days|||total nasal symptom score||Standard Deviation|Least Squares Mean
770861|NCT00720330|Secondary|Postoperative Nausea|Number of patients who had postoperative nausea or vomiting were recorded.|After surgery until the second postoperative day.|||Participants|||Count of Participants
770862|NCT00720330|Secondary|Pain Scores on Numerical Rating Scale|Numerical Rating Scales is a measurement of pain ranging from 0 to 10 (11 point scale), where 0 is equal to no pain and 10 is equal to worst possible pain. Pain scores were measured in PACU, first and second postoperative mornings.|After surgery until the second postoperative mornings.|||units on a scale||Standard Deviation|Mean
770863|NCT00720330|Secondary|Time From the End of Surgery to Readiness for Hospital Discharge.||Until hospital discharge, assessed up to 6 months|||hours||Standard Deviation|Mean
770864|NCT00720330|Secondary|Pre- and Intra-operative Opioid Consumption in Fentanyl Equivalents|The cumulative opioid consumption is calculated as fentanyl equivalent|From admission to the end of surgery|||mcg||Standard Deviation|Mean
770865|NCT00720330|Primary|Postoperative Opioid Consumption in Oral Oxycodone Equivalents|The cumulative opioid consumption after surgery until the end of second postoperative day.|2 days after surgery|||mg||Full Range|Mean
770866|NCT00720343|Secondary|Prevalence of Opioid Use||24 hours after surgery||||||
770867|NCT00720343|Secondary|Prevalence of High Blood Choline Concentration||24 hours after surgery||||||
770868|NCT00720343|Secondary|Prevalence of Nausea||24 hours after surgery||||||
770869|NCT00720343|Primary|Prevalence of Pain||24 hours after surgery|The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in March 2011.|||||
770870|NCT00720369|Secondary|We Measured Response to Treatment of Depression (Using the Montgomery Asberg Depression Rating Scale)in Older Adults With Bipolar Disorder After an 8 Week Trial of CoQ10.|"The Montgomery Asberg Depression Rating Scale (MADRS) is a 10 question questionnaire which assesses symptom severity of depression. The score is on a 0-60 scale with higher numbers indicating more severe depressive symptoms. The score is represented as a number of points.
Clinical improvement following treatment with CoQ10 supplement was only tested in the Bipolar subject cohort, not in healthy controls, therefore outcome data only apply to the bipolar group."|8 week trial|Clinical improvement following treatment with CoQ10 supplement was only tested in the Bipolar subject cohort, not in healthy controls, therefore outcome data only apply to the bipolar group.||units on a scale||Standard Deviation|Mean
770871|NCT00720369|Primary|We Measured the Change in Rate Constant of Creatine Kinase in Individuals With Bipolar Depression Treated With CoQ 10 as Compared With Age and Gender Matched Controls. These Rate Constants Were Calculated Using Magnetic Resonance Imaging (MRI).|The rate constant for creatine kinase is a measurement of the reaction rate ADP+PCr <---> ATP + Cr, which is catalyzed by the enzyme creatine kinase. The rate constant shows the direction and magnitude of the reaction at equilibrium. A higher rate constant indicates a higher rate constant of the CK enzyme, meaning, more efficient/rapid conversion of PCr to ATP through the creatine kinase enzymatic reaction in tissues with high and fluctuating energy demands such as brain and muscle tissue. As the value is a reaction rate, there are no associated units.|8 week trial|||per second||Standard Deviation|Mean
770872|NCT00720382|Other Pre-specified|Change From Baseline to 12 Months in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Compared to Placebo in Subjects 18 Years of Age and Older|"A 28-item RQLQ was completed on Day 1, Month 1, Month 3, Month 6, month 9 and month 12 or Early termination. The RQLQ consists of 7 domains rated on a 7 point scale with 0 being not troubled by the allergy symptoms, and 6 being extremely troubled/all of the time.
Domain score will be calculated from the mean score of all items in the domain. Overall score will be calculated from the mean score of all items."|change from baseline to 12 months|||Units on a scale||Standard Deviation|Least Squares Mean
770873|NCT00720382|Primary|Change From Baseline on Direct Visual Nasal Exams to 12 Months|Examination of head and neck (scale: None, Mild, Moderate, Severe) for Epistaxis, Mucosal Edema, Nasal Discharge, Mucosal erythema, Mucosal Bleeding, and Crusting of mucosa. Nasal irritation was rated: 0 = None, Grade 1A = focal irritation, Grade 1B = superficial mucosal erosion, Grade 2 = moderate mucosal erosion, Grade 3 = ulceration, Grade 4 = septal perforation|Change from baseline to 12 months|||Participants|||Number
770874|NCT00720434|Primary|Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4 - Modified Analysis Set|Plasma HCV RNA levels were measured using the Roche COBAS Taqman assay (limit of detection: 25 IU/mL). Baseline value calculated as the average of the screening and Day 1 pre-dose measurements.|Baseline, Week 4|Modified Analysis Set: subset of FAS that included all participants who completed the Week 4 visit.||log10 IU/mL||Standard Deviation|Mean
770877|NCT00720434|Secondary|Proportion of Participants Achieving Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)|Proportion of participants achieving undetectable plasma HCV RNA at Week 4 (rapid virologic response), at Week 12 (early virologic response), at Week 48 (end of treatment response), at Week 60 (sustained virologic response; 12 weeks after cessation of therapy), at Week 72 (sustained virologic response; 24 weeks after cessation of therapy) were summarized. Undetectable viral load was defined as HCV RNA <25 IU/mL.|Week 4, 12, 48, 60, 72|Modified Analysis Set: subset of FAS that included all participants who completed the Week 4 visit.||proportion of participants||95% Confidence Interval|Number
770878|NCT00720434|Primary|Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4 - Full Analysis Set|Plasma HCV RNA levels were measured using the Roche COBAS Taqman assay (limit of detection: 25 international unit per milliliter [IU/mL]). Baseline value calculated as the average of the screening and Day 1 pre-dose measurements.|Baseline, Week 4|Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study drug and had both baseline and at least 1 valid post-baseline endpoint measurements for HCV viral load. Here ‘n’ signifies participants evaluable for this measure at specified time points for each arm, respectively.||log10 IU/mL||Standard Deviation|Mean
770879|NCT00720473|Primary|Means of MADRS Scores at 8 Weeks|The minimum MADRS score is 0 and the maximum is 60, with 60 being the most depressed.|8 Weeks|MADRS scores were available for 16 bipolar subjects who completed the protocol and 8 healthy controls.||units on a scale||Standard Deviation|Mean
770880|NCT00720473|Primary|Mean Montgomery Asberg Depression Rating Scale (MADRS) Score at Baseline|The minimum MADRS score is 0 and the maximum is 60, with 60 being the most depressed.|Baseline|MADRS scores were available for 27 eligible bipolar subjects and 14 eligible controls.||units on a scale||Standard Deviation|Mean
770881|NCT00720473|Primary|Associations of MADRS Changes With NAA to Creatine Ratio Changes From Baseline to Follow-up|Estimated least squares mean metabolite ratio changes with a 10-point decrease in MADRS score. MADRS minimum score is 0 and maximum is 60, with 60 being most depressed. Estimate was from linear regression models controlling for age and sex. The change is across regions, parieto-occipital and anterior cingulate cortex.|8 weeks|Association between depression symptom severity and metabolite ratios were only conducted in the depressed group, because there should be no change in MADRS score for non-depressed control subjects who received no treatment.||NAA:Cr/-10 MADRS||95% Confidence Interval|Least Squares Mean
770882|NCT00720473|Primary|Associations of MADRS Changes With Glutamine to Creatine Ratio Changes From Baseline to Follow-up|Estimated least squares mean metabolite ratio changes with a 10-point decrease in MADRS score. MADRS minimum score is 0 and maximum is 60, with 60 being most depressed. Estimate was from linear regression models controlling for age and sex. The change is across regions, parieto-occipital and anterior cingulate cortex.|8 weeks|Association between depression symptom severity and metabolite ratios were only conducted in the depressed group, because there should be no change in MADRS score for non-depressed control subjects who received no treatment.||Gln:Cr/-10 MADRS Score||95% Confidence Interval|Least Squares Mean
770883|NCT00720473|Primary|Association of MADRS Changes With Glutamate to Creatine Ratio Changes From Baseline to Follow-up|Estimated least squares mean metabolite ratio changes with a 10-point decrease in MADRS score. The MADRS minimum score is 0 and maximum is 60, with 60 being the most depressed score. Estimate was from linear regression models controlling for age and sex. The change is across regions, parieto-occipital and anterior cingulate cortex.|8 Weeks|Association between depression symptom severity and metabolite ratios were only conducted in the depressed group, because there should be no change in MADRS score for non-depressed control subjects who received no treatment.||Glu:Cr/-10 MADRS||95% Confidence Interval|Least Squares Mean
770884|NCT00720473|Primary|Estimated Change in Least Squares Mean in the NAA to Creatine Ratio Between Baseline and Follow-up|Follow-up Least Squares Mean - Baseline Least Squares Mean|8 weeks|||NAA to creatine ratio||95% Confidence Interval|Least Squares Mean
770885|NCT00720473|Primary|Estimated Change in Least Squares Mean in the Glutamine to Creatine Ratio Between Baseline and Follow-up|Follow-up Least Squares Mean - Baseline Least Squares Mean|8 weeks|||serum Glutamine to Creatine ratio||95% Confidence Interval|Least Squares Mean
770886|NCT00720473|Primary|Estimated Change in Least Squares Mean in Glutamate to Creatine Ratio Between Baseline and Follow-up|Follow-up Least Squares Mean - Baseline Least Squares Mean|8 Weeks|||serum Glutamate to Creatine ratio||95% Confidence Interval|Least Squares Mean
770887|NCT00720473|Primary|Associations Between Depression Symptom Severity and Glutamate to Creatine Ratio at Baseline|Estimated changes in least squares mean in the metabolite ratio per 10-point increase in MADRS score. The minimum MADRS score is 0 and the maximum is 60, with 60 being the most depressed. Estimate was from linear regression models controlling for age and sex. The change is across regions, parieto-occipital and anterior cingulate cortex.|Baseline|Association between depression symptom severity and metabolite ratios were only conducted in the depressed group, because there should be no change in MADRS score for non-depressed control subjects who received no treatment.||Glu:Cr/+10 MADRS||95% Confidence Interval|Least Squares Mean
770888|NCT00720473|Primary|Mean N-Acetyl Aspartate (NAA) to Creatine Ratio by Diagnosis at Baseline||Baseline|Baseline scans were available for 37 participants. One participant was missing scan data.||Mean NAA to creatine ratio||Standard Deviation|Mean
770889|NCT00720473|Primary|Mean Glutamate to Creatine Ratio by Diagnosis at Baseline||Baseline|Baseline scans were available for 37 participants. One participant was missing scan data.||mean serum Glutamate to Creatine ratio||Standard Deviation|Mean
770890|NCT00720473|Primary|Mean Glutamine to Creatine Ratio by Diagnosis at Baseline||Baseline|Baseline scans were available for 37 participants. One participant was missing scan data.||mean serum Glutamine to Creatine ratio||Standard Deviation|Mean
770891|NCT00720499|Secondary|AUC (0-6H) FEV1 (Unsupervised), AUC (0-6H) PEFR (Unsupervised), FVC Peak (0-3h), AUC (6-12h) FEV1 (Unsupervised), AUC (6-12h) PEFR (Unsupervised), Individual PEFR Measurements (Supervised and Unsupervised), Individual PEFR Measurements (Unsupervised)|"AUC (0-6h) for FEV1, and PEFR (unsupervised) after first dose and after 2 and 4 weeks of treatment were not analysed in the study report because the pertinent information from the unsupervised Pulmonary Function Tests (PFTs) was for the time interval from 6 to 12 hours post-dosing.
FVC peak 0-3h response after the first dose and at Week 2 (supervised) and AUC (6-12h) for FEV1 and PEFR after the first dose and at Week 2 (unsupervised) were not analysed in the study report.
Individual PEFR (supervised) measurements and individual FEV1 and PEFR (unsupervised) measurements at each time point were not analysed in the study report."|4 weeks|No patients analyzed in the study report.|||||
770894|NCT00720499|Secondary|12-lead ECG QTcF Intervals|"12-lead ECG corrected heart rate (QT) interval, using Fridericia method (QTcF), baseline and change from baseline at other time points in milliseconds.
Statistics for each planned time from baseline to day 29."|Baseline, then 10min, 1h after drug administration on day 1, 30min before and 10min after drug administration on day 15, in addition 1h after drug administration on day 29|TS||mS||Standard Deviation|Mean
770895|NCT00720499|Secondary|12-lead ECG QRS Intervals|"12-lead ECG QRS intervals baseline and change from baseline at other time points in milliseconds
Statistics for each planned time from baseline to day 29."|Baseline, then 10min, 1h after drug administration on day 1, 30min before and 10min after drug administration on day 15, in addition 1h after drug administration on day 29|TS||mS||Standard Deviation|Mean
770896|NCT00720499|Secondary|12-lead ECG PR Intervals|"12-lead ECG PR intervals baseline and change from baseline at other timepoints in milliseconds.
Statistics for each planned time from baseline to day 29."|Baseline, then 10min, 1h after drug administration on day 1, 30min before and 10min after drug administration on day 15, in addition 1h after drug administration on day 29|TS||mS||Standard Deviation|Mean
770897|NCT00720499|Secondary|12-lead ECG Heart Rate|"12-lead Electrocardiogram (ECG) Heart rate baseline and change from baseline values at other time points in Beats Per Minute (BPM)
Statistics for each planned time from baseline to day 29."|Baseline, then 10min, 1h after drug administration on day 1, 30min before and 10min after drug administration on day 15, in addition 1h after drug administration on day 29|TS||BPM||Standard Deviation|Mean
770898|NCT00720499|Secondary|Overall Marked Changes From Baseline in Vital Signs|Overall marked changes from baseline in systolic blood pressure, diastolic blood pressure and pulse rate.|Baseline to week 14|TS||participants|||Number
770899|NCT00720499|Secondary|Clinically Significant Abnormalities for Blood Chemistry, Haematology, Urinalysis and Physical Examination|Clinically significant abnormalities for blood chemistry, haematology, urinalysis and physical examination|14 weeks|Treated Set (TS) including all randomized patients who received at least one dose of study medication.||participants|||Number
770900|NCT00720499|Secondary|Physician’s Global Evaluation|"Physician’s global evaluation score on days 15 and 29
The score was evaluated on a 8-points scale :
Poor : 1,2
Fair : 3,4
Good : 5,6
Excellent : 7,8
The presented means are adjusted"|Days 15 and 29|FAS||units on a scale||Standard Error|Mean
770901|NCT00720499|Secondary|Patient Global Rating|"Patient global rating scores treatment comparison after 4 weeks
The score was evaluated on a 7-point scale :
1 : very much better
2 : much better
3 : a little better
4 : no change
5 : a little worse
6 : much worse
7 : very much worse
The presented means are adjusted."|4 weeks|FAS||units on a scale||Standard Error|Mean
770902|NCT00720499|Secondary|Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (PRN Salbutamol [Albuterol])|"Weekly mean number of occasions of rescue therapy used per day (as occasion require (PRN) salbutamol [albuterol]) on weeks 1,2,3 and 4.
The means presented are the adjusted mean of weekly mean."|Weeks 1,2,3 and 4|FAS||number of occasions / day||Standard Error|Mean
770903|NCT00720499|Secondary|Weekly Mean Evening PEFR|"Weekly mean evening PEFR [L/min] on weeks 1,2,3 and 4.
The presented means are adjusted."|Weeks 1,2,3 and 4|FAS||Litres / minute||Standard Error|Mean
770904|NCT00720499|Secondary|Weekly Mean Morning PEFR|"Weekly mean morning PEFR [L/min] on weeks 1,2,3 and 4.
The presented means are adjusted."|Weeks 1,2,3 and 4|FAS||Litres / minute||Standard Error|Mean
770905|NCT00720499|Secondary|PEFR AUC (6-12h) Response|"PEFR AUC (6-12h) response [L] on day 29.
Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.
The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)."|1 hour (h) and 10 minutes before drug administration on day 1 and 6h, 9h and 12h after drug administration on day 29|FAS||Litres / minute||Standard Error|Mean
770906|NCT00720499|Secondary|PEFR Peak 0-3h Response|"PEFR peak 0-3h response [L/min] on days 1, 15 and 29.
Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.
The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)."|1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on days 1, 15 and 29|FAS||Litres / minute||Standard Error|Mean
770907|NCT00720499|Secondary|PEFR AUC (0-3h) Response|"Peak Expiratory Flow Rate (PEFR) AUC (0-3h) response [L/min] on days 1, 15 and 29.
Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.
The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)."|1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on days 1, 15 and 29|FAS||Litres / minute||Standard Error|Mean
770908|NCT00720499|Secondary|FVC Peak 0-3h Response|"FVC peak 0-3h response [L] on day 29.
Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.
The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)."|1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on day 29|FAS||Litres||Standard Error|Mean
770909|NCT00720499|Secondary|FVC AUC (0-6h) Response|"FVC AUC (0-6h) response [L] on day 29.
Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.
The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)."|1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h, 4h, 5h, 6h after drug administration on day 29|FAS||Litres||Standard Error|Mean
770910|NCT00720499|Secondary|FVC AUC (0-3h) Response|"FVC AUC (0-3h) response [L] on days 1, 15 and 29.
Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.
The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)."|1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on days 1, 15 and 29|FAS||Litres||Standard Error|Mean
778139|NCT00774163|Primary|Leukocyte Count on Day 5||Measured on day 5|||cells per cubic millimeter||Standard Deviation|Mean
770912|NCT00720499|Secondary|Trough FVC Response|"Trough Forced Vital Capacity (FVC) response [L] on days 15 and 29.
Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.
The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)."|1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on day 15, in addition 4h, 5h, 6h after drug administration on day 29|FAS||Litres||Standard Error|Mean
770913|NCT00720499|Secondary|FEV1 (Unsupervised) AUC (6-12h) Response|"FEV1 (unsupervised) AUC (6-12h) response [L] on day 29.
Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.
The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)."|6 hours (h), 9h and 12h after drug administration on day 29|FAS||Litres||Standard Error|Mean
770914|NCT00720499|Secondary|FEV1, AUC (0-6h) Response|"FEV1, AUC (0-6h) response [L] on day 29.
Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.
The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)."|1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h, 4h, 5h, 6h after drug administration on day 29|FAS||Litres||Standard Error|Mean
770915|NCT00720499|Secondary|FEV1 Peak 0-3h Response|"FEV1 peak value over the time from 0 to 3 hours (peak 0-3h) response [L] on days 1, 15 and 29.
Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.
The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)."|1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on days 1, 15 and 29|FAS||Litres||Standard Error|Mean
770916|NCT00720499|Secondary|FEV1 AUC 0-3h, Response|"FEV1 Area Under the Curve (AUC) 0-3h, response [L] on days 1, 15 and 29.
Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.
The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)."|1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on days 1, 15 and 29|FAS||Litres||Standard Error|Mean
770917|NCT00720499|Secondary|Individual FEV1 Measurements|"Individual FEV1 measurements [L] at each time point on Day 29.
The presented means are adjusted."|1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h, 4h, 5h, 6h after drug administration on day 29|FAS||Litres||Standard Error|Mean
770918|NCT00720499|Secondary|Trough FEV1 Response [L] After 2 Weeks of Treatment|"Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.
The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)."|1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on day 15|FAS||Litres||Standard Error|Mean
770919|NCT00720499|Primary|Trough Forced Expiratory Volume in One Second (FEV1) Response [L] After Four Weeks of Treatment.|"Trough FEV1 was defined as the mean of the 2 FEV1 values at the end of the dosing interval, 24 hours post-drug administration.
Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.
The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)."|1 hour (h), 10 minutes (min) before drug administration and 5min, 30min, 1h, 2h, 3h, 4h, 5h, 6h after drug administration on day 29|Full analysis Set (FAS) which included all randomized patients who received at least one dose of study medication and had baseline data and Washout Period for at least 1 efficacy endpoint for each treatment period.||Litres||Standard Error|Mean
770920|NCT00720629|Secondary|Pharmacodynamics of Visilizumab - Test 2|Mean terminal half-life (±SD)|Up to 205 hours|All participants||hours||Standard Deviation|Mean
770921|NCT00720629|Secondary|Pharmacodynamics of Visilizumab - Test 1|Mean Cmax (±SD)|At 1 - 2 hours|All participants||ng/mL||Standard Deviation|Mean
770922|NCT00720629|Secondary|Overall Survival (OS)|Median OS in days. Survival was measured from the time of transplant to the time of death.|At 2 years and 5 years|Participants who had died by Year 2 and additional participants who had died by Year 5.||days||Full Range|Median
770923|NCT00720629|Secondary|Incidence of Rituximab Response to Reactivated EBV Without PTLD|"Participants who developed plasma EBV-DNA of >1000 copies/mL on any tests received rituximab.
Incidence of Rituximab Response: Reactivated EBV participants whose plasma titers cleared after rituximab, without post-transplant lymphoproliferative disorder (PTLD)."|100 days|Reactivated EBV participants||participants|||Number
770924|NCT00720629|Secondary|Incidence of Epstein-Barr Virus (EBV) Reactivation|Number of participants who reactivated EBV. Patients had their plasma tested once weekly using the TaqMan polymerase chain reaction (PCR) for quantitative determination of EBV-DNA for 6 weeks. Plasma levels > 1000 copies per ml plasma were scored as positive.|3 months|All participants||participants|||Number
770925|NCT00720629|Primary|Number of Participants With Grade II-IV Acute Graft-versus-Host Disease (GVHD) Score at 100 Days|"Cumulative Incidence of Grade II-IV Acute GVHD Score at 100 Days. Investigators had planned to assess whether the grade of acute GVHD was decreased by visilizumab in combination with tacrolimus/methotrexate compared to standard treatment with thymoglobulin/tacrolimus/methotrexate after transplantation from unrelated mismatched donors, from day of transplant up to one year. Study was closed during the first treatment stage and did not proceed to the second stage treatment comparison to ATG in combination with tacrolimus/methotrexate as originally planned.
Overall GVHD Grade: From Filipovich AH, Weisdorf D, Pavletic S, etal: National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: I. Diagnosis and Staging Working Group Report. Biology of Blood and Marrow Transplantation 11:945-955 (2005). Grade I: Skin Stage 1-2, Liver Stage 0, Gut State 0; Grade II: Skin Stage 3 or, Liver Stage 1 or, Gut Stage 1; Grade II"|100 days|All participants||participants|||Number
770926|NCT00720759|Primary|Wolf Motor Function Test (Time)|The Wolf Motor Function Test (time) score is the average time in seconds taken to perform each of 15 functional tasks ranging in difficulty from putting one’s forearm on a table to stacking checkers. Participants are given 120 seconds to perform a task and if they fail, they are scored 120 for that task. Score range on the WMFT-T is 0-120, lower scores being better.|3 months after completion of treatment|||units on a scale||Standard Deviation|Mean
770927|NCT00720798|Secondary|Percentage of Participants With a Clinically Relevant Improvement in the Physical and Mental Component Scores of the Short Form 36 (SF-36) Health Survey at Weeks 24, 48, 108, 156, 204, and 264|The SF-36 Health Survey uses participant-reported symptoms on 8 subscales to assess health-related quality of life (HRQoL). The Physical Component Summary (PCS) score summarizes the subscales Physical Functioning, Role-Physical, Bodily Pain, and General Health. The Mental Component Summary (MCS) score summarizes the subscales Vitality, Social Functioning, Role-Emotional, and Mental Health. Each score was scaled from 0 to 100 with a higher score indicating better HRQoL. A clinically relevant improvement in the Physical and Mental Component Scores of the SF-36 was defined as a ≥ 5-point increase from Baseline.|Baseline to Week 264|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.||Percentage of participants|||Number
770928|NCT00720798|Secondary|Percentage of Participants With a Clinically Relevant Improvement in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Weeks 24, 36, 48, 108, 156, 204, and 264|The FACIT-F is a 13-item participant self-report questionnaire that assesses fatigue over the previous 7 days by scoring each item on a 5-point scale (0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit, 4=Very much). An overall FACIT-F score was obtained by summing the scores of all 13 items. The overall score ranged from 0 to 52. A lower score indicates less fatigue. A clinically relevant improvement in the FACIT-F score was defined as a ≥ 5-point increase from Baseline.|Baseline to Week 264|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.||Percentage of participants|||Number
770929|NCT00720798|Secondary|Percentage of Participants Who Maintained a Disease Activity Score 28 (DAS-28) Response for 24, 48, 96, 144, and 192 Weeks at Weeks 48, 96, 144, 192, and 264|A DAS-28 responder was defined as someone who met the European League Against Rheumatism [EULAR] criteria of a good or moderate response. A change of the DAS-28 score from Baseline was used to determine EULAR responses of good, moderate, or no response. For a post-baseline score ≤ 3.2, a change from baseline of < -1.2 was a good response, < -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-baseline score > 3.2 to ≤ 5.1, a change from baseline of < -0.6 was a moderate response and ≥ -0.6 was no response. For a post-baseline score > 5.1, a change from baseline < -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-baseline scores > 3.2.|Baseline to Week 264|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.||Percentage of participants|||Number
770930|NCT00720798|Secondary|Percentage of Participants Who Were Disease Activity Score 28 (DAS-28) Responders at Weeks 24, 48, 108, 156, 204, and 264|A DAS-28 responder was defined as someone who met the European League Against Rheumatism [EULAR] criteria of a good or moderate response. A change of the DAS-28 score from Baseline was used to determine EULAR responses of good, moderate, or no response. For a post-baseline score ≤ 3.2, a change from baseline of < -1.2 was a good response, < -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-baseline score > 3.2 to ≤ 5.1, a change from baseline of < -0.6 was a moderate response and ≥ -0.6 was no response. For a post-baseline score > 5.1, a change from baseline < -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-baseline scores > 3.2.|Baseline to Week 264|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.||Percentage of participants|||Number
770931|NCT00720798|Secondary|Change in the Disease Activity Score 28 (DAS-28) From Baseline to Weeks 24, 48, 96, and 264|The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient’s global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A negative change score indicates improvement.|Baseline to Week 264|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.||Units on a scale||Standard Deviation|Mean
770932|NCT00720798|Secondary|Erythrocyte Sedimentation Rate at Baseline and Weeks 24, 48, 108, 156, 204, and 264|Erythrocyte sedimentation rate (ESR) was determined locally.|Baseline to Week 264|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.||mm/h||Standard Deviation|Mean
770939|NCT00720798|Secondary|Percentage of Participants Who Changed From Monotherapy to Combination Therapy|Participants who entered this study from study WA17824 on tocilizumab monotherapy, who did not achieve a 50% reduction in tender and swollen joint counts from Baseline of study WA17824, could add methotrexate or another allowable disease-modifying anti-rheumatic drug, according to the investigator’s practice and as tolerated by the patient, at any time during this study.|Baseline to Week 296|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants from the core study WA17824 are included in the analysis.||Percentage of participants|||Number
772398|NCT00725296|Primary|Median Dose of All Infusions Per Participant|The median dose of all infusions among all Infliximab-naive participants measured in mg/kg.|Up to 24 Months|152 out of the 159 Infliximab-naive participants were treated in the active phase.||mg/kg||Full Range|Median
770933|NCT00720798|Secondary|Health Assessment Questionnaire-Disability Index Score at Baseline and Weeks 24, 48, 108, 156, 204, and 264|The Health Assessment Questionnaire-Disability Index (HAQ-DI), as a measure of functional ability, consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. There are 4 possible responses to each question (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do). A domain score is the highest score in that domain. To calculate the overall score, the patient must have a domain score in at least 6 of the 8 domains. The HAQ-DI score is the sum of the domain scores divided by the number of domains that have a non-missing score and ranges from 0 (best) to 3 (worst). A higher score indicates less ability.|Baseline to Week 264|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.||Units on a scale||Standard Deviation|Mean
770934|NCT00720798|Secondary|Disease Activity and Pain at Baseline and Weeks 24, 48, 108, 156, 204, and 264|Participant’s made a global assessment of their current disease activity on a 100 mm horizontal visual analogue scale (VAS). The left end of the scale indicated “no disease activity” (symptom-free and no arthritis symptoms, score = 0) and the right end indicated “maximum disease activity” (maximum arthritis disease activity, score = 100). The participant’s treating physician made a global assessment of the participant’s current disease activity on a 100 mm horizontal VAS. The left end of the scale indicated “no disease activity” (symptom-free and no arthritis symptoms, score = 0) and the right end indicated “maximum disease activity” (maximum arthritis disease activity, score = 100). Participant’s made an assessment of their current level of pain on a 100 mm horizontal VAS. The left end of the scale indicated “no pain” (score = 0) and the right end of the scale indicated “unbearable pain” (score = 100).|Baseline to Week 264|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.||mm||Standard Deviation|Mean
770935|NCT00720798|Secondary|Swollen and Tender Joint Count (SJC/TJC) at Baseline and Weeks 24, 48, 108, 156, 204, and 264|The number of swollen (66 assessed joints) and tender (68 assessed joints) joints was assessed. Joints were physically examined and classified as swollen/not swollen and tender/not tender by pressure and joint manipulation.|Baseline to Week 264|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.||Joints||Standard Deviation|Mean
770936|NCT00720798|Secondary|Percentage of Participants Who Maintained an Improvement of at Least 20%, 50%, or 70% in the American College of Rheumatology (ACR) Score (ACR20/50/70) Consecutively for 24, 48, 96, and 264 Weeks at Weeks 48, 96, 144, 192, and 264|Improvement must be seen in tender (68 assessed joints) and swollen joint counts (66 assessed joints) and in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, the left end of the scale “no disease activity” [symptom-free and no arthritis symptoms], right end of the scale “maximum disease activity”); patient assessment of pain in the previous 24 hours on a VAS (left end of the scale “no pain”, right end of the scale “unbearable pain”); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and erythrocyte sedimentation rate.|Baseline to Week 264|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.||Percentage of participants|||Number
770937|NCT00720798|Secondary|Percentage of Participants Who Achieved a Major Clinical Response at Weeks 48, 96, 144, 192, and 264|A major clinical response was defined as maintenance of an improvement of at least 70% in the American College of Rheumatology (ACR) score (ACR70) for at least 24 weeks. Improvement must be seen in tender (68 assessed joints) and swollen joint counts (66 assessed joints) and in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, the left end of the scale “no disease activity” [symptom-free and no arthritis symptoms], right end of the scale “maximum disease activity”); patient assessment of pain in the previous 24 hours on a VAS (left end of the scale “no pain”, right end of the scale “unbearable pain”); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and erythrocyte sedimentation rate.|Baseline to Week 264|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.||Percentage of participants|||Number
770938|NCT00720798|Secondary|Percentage of Participants With an Improvement of at Least 20%, 50%, 70%, or 90% in the American College of Rheumatology (ACR) Score (ACR20/50/70/90) From Baseline at Weeks 24, 48, 108, 156, 204, and 264|Improvement must be seen in tender (68 assessed joints) and swollen joint counts (66 assessed joints) and in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, the left end of the scale “no disease activity” [symptom-free and no arthritis symptoms], right end of the scale “maximum disease activity”); patient assessment of pain in the previous 24 hours on a VAS (left end of the scale “no pain”, right end of the scale “unbearable pain”); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and erythrocyte sedimentation rate.|Baseline to Week 264|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.||Percentage of participants|||Number
770965|NCT00721110|Primary|The Effects of Lidocaine and Ketamine on Functional Recovery Assessed by 6 Minute Walk Test on Postoperative Day Two|The effects of lidocaine and ketamine on functional recovery assessed by 6 minute walk test on postoperative day two after hysterectomy. This outcome measures return to ambulation after surgery.|postoperative day 2|||meters||Standard Deviation|Mean
778140|NCT00774163|Primary|Mean Daily Temperature|Measured daily during 5 days of study product administration|5 days of study product administration|||Degrees Celcius||Standard Deviation|Mean
770940|NCT00720798|Secondary|Percentage of Participants With Concomitant Oral Corticosteroid Therapy|"Concomitant therapy with oral corticosteroids (up 5 to 10 mg daily prednisone or equivalent) was permitted in the study. Reduction of oral corticosteroids was permitted, but not required, if a patient achieved at least a 50% improvement from baseline in both tender joint count and swollen joint count.
The data are reported for each 6-month period of the study where a month = 28 days. The last 6-month period is for months 96 through 101. The actually study duration in 28-day months was 98.85 months."|Baseline to the end of the study (up to 7 years, 7 months)|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.||Percentage of participants|||Number
770941|NCT00720798|Secondary|Percentage of Participants Who Withdrew From Treatment||Baseline to the end of the study (up to 7 years, 7 months)|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.||Percentage of participants|||Number
770942|NCT00720798|Primary|Percentage of Participants With ≥ 1 Adverse Event||Baseline to the end of the study (up to 7 years, 7 months)|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.||Percentage of participants|||Number
770943|NCT00720941|Secondary|MRU: The Mean Number of Laboratory Visits, Radiology Visits, Home Healthcare Visits, and Medical Procedures for Cycles 1-4. MRU Data Collected at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)|The number of non-study laboratory visits (NSLVs), non-study radiology visits (NSRVs), and home healthcare visits (HHVs) were each collected as a single question on the eCRF. The number of non-study medical or surgical procedures (MSPs) was defined as the sum of procedures performed at outpatient or physician clinics, as well as those performed during any inpatient hospitalization.|Weeks 4, 10, 16, and 22|ITT Population. Only those participants who had NSLVs, NSRVs, HHVs, and medical procedures were analyzed.||visits||Standard Deviation|Mean
770944|NCT00720941|Secondary|Medical Resource Utilization (MRU): Assessed as the Mean Number of Non-study Medical Visits, Telephone Consultations, Hospital Days, and Emergency Room (ER) Visits Per 30 Days Through Week 24|Non-study medical visits were defined as the sum of primary care physician visits, nurse practitioner/physician’s assistant/nurse visits, and medical or surgical specialist visits. Days hospitalized were defined as the sum of days in the general ward and days in intensive care. The number of telephone consultations and ER visits was assessed via individual questions on the electronic Case Report Form. The endpoint was totaled through Week 24, divided by the number of days on treatment for each participant, then multiplied by 30 days to get the number of visits per 30 days.|From Day 1 up to Week 24|ITT Population. Only those participants who had non-study medical visits, telephone consulations, days in the hospital, and ER visits were analyzed.||events per 30 days||Standard Deviation|Mean
770945|NCT00720941|Secondary|Summary of Analysis for the Cancer Treatment Satisfaction Questionnaire (CTSQ) Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)|The CTSQ assesses 3 domains related to the participant’s satisfaction with cancer therapy: Expectations of Therapy (ET), Feelings about Side Effects (FSE), and Satisfaction with Therapy (SWT). Participants shared their thoughts on their cancer therapy (9 questions), their satisfaction with their most recently administered cancer therapy (6 questions), and if they would take the same cancer therapy if given the choice to do so again. All questions were assessed on a 5-point scale; 1, never; 5, always. Scores were averaged and transformed to a 0-100 scale; higher scores represent better health.|Weeks 4, 10, 16, and 22|ITT Population. Participants missing scores at early time points were excluded from the analysis at those time points. Mean total score was calculated at each assessment week.||Scores on a scale||Standard Deviation|Mean
770946|NCT00720941|Secondary|Change From Baseline in the Supplementary Quality of Life Questions (SQLQ) Limitations Due to Foot Soreness Scores at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)|"The SQLQ consists of 5 items assessing the worst mouth/throat, hand, and foot soreness, and limitations due to mouth/throat and foot soreness. Par. assessed the limitations caused by their foot soreness by answering the question of In the past 4 weeks, how much did your worst foot soreness limit you in each of the following activities: standing/walking/climbing stairs/sleeping/ability to do usual activities by using the following 4-point scale: 0, not limited; 1, limited a little; 2, limited a lot; 3, unable to do. The overall limitation score (15=best; 0=worst), based on the individual scores for the 5 activities, is derived as follows: the actual scores were rescored by subtracting the actual score from 3 for each of the 5 categories. A high score indicates less limitation. Change from Baseline was calculated as the assessment week value minus the Baseline value. A negative mean change from Baseline represents a worsening of condition."|Baseline; Weeks 4, 10, 16, and 22|ITT Population. Some participants were missing scores at Baseline and were excluded from the analysis. Participants missing scores at other early time points were excluded from the analysis at those time points.||Scores on a scale||Standard Deviation|Mean
770947|NCT00720941|Secondary|Change From Baseline in the Supplementary Quality of Life Questions (SQLQ) Limitations Due to Mouth and Throat Soreness Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)|"The SQLQ consists of 5 items assessing the worst mouth/throat, hand, and foot soreness, and limitations due to mouth/throat and foot soreness. Participants (par.) assessed the limitations caused by their mouth/throat soreness by answering the question of In the past 4 weeks, how much did your worst mouth/throat soreness limit you in the following activities: swallowing/eating/drinking/talking/sleeping by using the following 4-point scale: 0, not limited; 1, limited a little; 2, limited a lot; 3, unable to do. The overall limitation score (15=best; 0=worst), based on the individual scores for the 5 activities, is derived as follows: the actual scores were rescored by subtracting the actual score from 3 for each of the 5 categories. A high score indicates less limitation. Change from Baseline was calculated as the assessment week value minus the Baseline value. A negative mean change from Baseline represents a worsening of condition."|Baseline; Weeks 4, 10, 16, and 22|ITT Population. Some participants were missing scores at Baseline and were excluded from the analysis. Participants missing scores at other early time points were excluded from the analysis at those time points.||Scores on a scale||Standard Deviation|Mean
771033|NCT00715676|Secondary|Percent Change From Baseline in Trochanter Bone Mineral Density (BMD) at Week 52|Percent change in trochanter BMD (relative to baseline) at Week 52|Baseline and Week 52|This analysis was performed on the Full Analysis Set, which included all subjects who received at least one dose of study drug. Multiple imputation was used for missing data.||Percent change||Standard Deviation|Mean
770948|NCT00720941|Secondary|Change From Baseline in the Supplementary Quality of Life Questions (SQLQ) Scale Worst Soreness Scores at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)|"The SQLQ scale consists of 5 items that assess the worst mouth and throat, hand, and foot soreness, as well as limitations due to mouth/throat and foot soreness. Participants were asked to assess their worst mouth/throat, hand, and foot soreness by answering the question of  In the past 4 weeks, what was your worst mouth/throat, hand, and foot soreness? by using the following 4-point scale: 0, I never had any soreness; 1, I had a little bit of soreness; 2, I had quite a lot of soreness; 3, I had severe soreness. A positive mean change from Baseline represents a worsening of condition."|Baseline; Weeks 4, 10, 16, and 22|ITT Population. Some participants were missing scores at Baseline and were excluded from the analysis. Participants missing scores at other early time points were excluded from the analysis at those time points. Change from Baseline was calculated as the assessment week value minus the Baseline value.||Scores on a scale||Standard Deviation|Mean
770949|NCT00720941|Secondary|Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Total Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)|The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains (DRS-P, DRS-E, TSE, and FWB). Participants are asked to respond to a total of 19 questions regarding symptoms, side effects, and well being by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total score of 0 to 76). Higher scores represent better health. A negative change from Baseline represents a worsening of condition.|Baseline; Weeks 4, 10, 16, and 22|ITT Population. Some participants were missing scores at Baseline and were excluded from the analysis. Participants missing scores at other early time points were excluded from the analysis at those time points. Change from Baseline was calculated as the assessment week value minus the Baseline value.||Scores on a scale||Standard Deviation|Mean
770950|NCT00720941|Secondary|Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Functional Well Being (FWB) Domain Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)|"The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The FWB domain assesses well being in the past 7 days. Participants are asked to respond to 3 questions (I am able to work, I am able to enjoy life, and I am content with the quality of my life now) by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 12). Higher scores represent better health. A negative change from Baseline represents a worsening of condition."|Baseline; Weeks 4, 10, 16, and 22|ITT Population. Some participants were missing scores at Baseline and were excluded from the analysis. Participants missing scores at other early time points were excluded from the analysis at those time points. Change from Baseline was calculated as the assessment week value minus the Baseline value.||Scores on a scale||Standard Deviation|Mean
770951|NCT00720941|Secondary|Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Treatment Side Effects (TSE) Domain Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)|"The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The TSE domain assesses side effects experienced in the past 7 days. Participants are asked to respond to 3 questions (I have nausea, I have diarrhea, and I am bothered by side effects of treatment) by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 12).Higher scores represent better health. A negative change from Baseline represents a worsening of condition."|Baseline; Weeks 4, 10, 16, and 22|ITT Population. Some participants were missing scores at Baseline and were excluded from the analysis. Participants missing scores at other early time points were excluded from the analysis at those time points. Change from Baseline was calculated as the assessment week value minus the Baseline value.||Scores on a scale||Standard Deviation|Mean
770952|NCT00720941|Secondary|Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Disease Related Symptoms-emotional (DRS-E) Domain Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)|"The FKSI-19 is a disease-specific instrument measuring disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The DRS-E domain assesses symptoms experienced in the past 7 days. Participants are asked to respond to the question of I worry that my condition will get worse by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 4). A negative change from Baseline (BL) represents a worsening of condition. Change from BL was calculated as the assessment week value minus the BL value."|Baseline; Weeks 4, 10, 16, and 22|ITT Population. Some participants were missing scores at Baseline and were excluded from the analysis. Participants missing scores at other early time points were excluded from the analysis at those time points.||Scores on a scale||Standard Deviation|Mean
770953|NCT00720941|Secondary|Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Disease-related Symptoms-physical (DRS-P) Domain Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)|"The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The DRS-P domain assesses symptoms experienced in the past 7 days. Participants are asked to respond to 12 questions (I have a lack of energy, I feel pain, for example) by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 48). Higher scores represent better health. A negative change from Baseline represents a worsening of condition."|Baseline; Weeks 4, 10, 16, and 22|ITT Population. Some participants were missing scores at Baseline and were excluded from the analysis. Participants missing scores at other early time points were excluded from the analysis at those time points. Change from Baseline was calculated as the assessment week value minus the Baseline value.||Scores on a scale||Standard Deviation|Mean
770986|NCT00721149|Primary|The Percentage of Subjects Who Experienced Incidences of Early Onset (Within 7 Days of Ablation Procedure) Catheter-related Adverse Events.|Catheter-related adverse events include death, myocardial infarction, pulmonary vein stenosis, diaphragmatic paralysis, atrio-esophageal fistula, transient ischemic attack, stroke, cerebrovascular accident, thromboembolism, pericarditis, cardiac tamponade, pericardial effusion, pneumothorax, atrial perforation, vascular access complications, pulmonary edema, hospitalization (initial and prolonged), and heart block.|within 7 days of ablation procedure|The subjects who had a study ablation procedure.||Percentage of participants|||Number
770954|NCT00720941|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-F) Scale Scores at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)|The FACIT-F scale measures the severity and impact of fatigue on functioning and health related quality of life (HRQoL) experienced in the past seven days. The level of fatigue is measured by 13 questions assessed on a four-point scale (0=not at all fatigued; 1=a little bit fatigued; 2=somewhat fatigued; 3=quite a bit fatigued; 4=very much fatigued; possible total score of 0 to 52). A negative change from Baseline represents a worsening condition. Change from Baseline was calculated as the assessment week value minus the Baseline value.|Baseline (predose); Weeks 4, 10, 16, and 22|ITT Population. Some participants were missing scores at Baseline and were excluded from the analysis. Participants missing scores at some of the other early time points were excluded from the analysis at those time points.||Scores on a scale||Standard Deviation|Mean
770955|NCT00720941|Secondary|Number of Participants (Par.) With Serious Adverse Events (SAEs)/Non-serious Adverse Events (Any Untoward Medical Occurrence in a Par. Administered a Pharmaceutical Product and Which Does Not Necessarily Have a Causal Relationship With This Treatment)|See the SAE/AE module for a list of all SAEs/AEs. SAE=any event occurring at any dose that results in any of the following: death, a life-threatening adverse drug experience (ADE; at immediate risk of death from the experience as it occurred), inpatient hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, a congenital anomaly/birth defect, or a Grade 4 laboratory abnormality. Events that may not result in death, be life-threatening, or require hospitalization may be considered to be a serious ADEs when based upon appropriate medical judgment.|From the time of the first dose of study drug to approximately one month after the discontinuation of study drug (up to Study Week 268)|Safety Population: all randomized participants who received at least one dose of study medication, according to the actual treatment received.||Participants|||Number
770956|NCT00720941|Secondary|Duration of Response (DOR)|DOR is defined as the time from the first documented evidence of response (CR or PR) until the first documented sign of disease progression (a >=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of >=1 new lesion) or death, if sooner. CR=the disappearance of all target and non-target lesions. PR=at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD.|From the time of the first documented confirmed complete or partial response until disease progression or death, if sooner (up to Study Week 167)|ITT Population. Only those participants who had either a confirmed CR or PR were analyzed.||Months||95% Confidence Interval|Median
770957|NCT00720941|Secondary|Time to Response|Time to response is defined as the time from the start of treatment until the first documented evidence of CR (the disappearance of all target and non-target lesions) or PR (at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD), whichever comes first. CR and PR were evaluated by an independent review per RECIST, Version 1.|From randomization until the time of the first documented confirmed complete or partial response (up to Study Week 167)|ITT Population. Only those participants who experienced either a confirmed CR or a PR were analyzed.||Weeks||95% Confidence Interval|Median
770958|NCT00720941|Secondary|Number of Participants in the Indicated Categories for Overall Response as Assessed by Independent Review|The number of participants with evidence of CR (the disappearance of all target and non-target lesions), PR (at least a 30% decrease in the sum of the longest diameters [LD] of target lesions, taking as a reference the Baseline sum LD), Stable Disease (small changes that do not meet previously given criteria), or Progressive Disease (a >=20% increase in target lesions within the first 12 weeks of treatment) was evaluated by an independent review per RECIST, Version 1.|From randomization until the time of a confirmed best response of CR or PR (up to Study Week 167)|ITT Population||Participants|||Number
770959|NCT00720941|Secondary|Overall Survival|Overall survival is defined as the time from randomization until death due to any cause.|From randomization until death (up to Study Week 268)|ITT Population. Participants who had not died were censored at the date of the last adequate tumor assessment at the time of the cut-off.||Months||95% Confidence Interval|Median
770960|NCT00720941|Primary|Progression-free Survival (PFS)|PFS is defined as the interval between the date of randomization and the earliest date of progressive disease (PD), as defined by the Independent Review Committee (IRC), or death due to any cause. The IRC defined PD per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1. Per RECIST, PD is defined as a >=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of >=1 new lesion. The Kaplan-Meier method was used for PFS estimates.|From randomization until the earliest date of disease progression or death (up to Study Week 191)|Intent-to-Treat (ITT) Population: all participants randomized to receive treatment. Analysis was based on the assigned randomized treatment, not on the actual treatment received/not received. Participants who had neither progressed nor died were censored at the date of the last adequate tumor assessment at the time of the cut-off.||Months||95% Confidence Interval|Median
770961|NCT00721110|Secondary|Verbal Response Fatigue Score on Postoperative Day 1|Verbal response fatigue score on postoperative day 1. Verbal response fatigue score measured on a scale ranging from 0 to 10, where 0 is no fatigue and 10 is the worst possible fatigue.|postoperative day 1|11 patients had missing POD 1 fatigue scores (e.g., 11 for lidocaine vs. nonlidocaine and 11 for ketamine vs. nonketamine).||units on a scale||Standard Deviation|Mean
770962|NCT00721110|Secondary|Presence of Nausea and Vomiting After Two Hours in the PACU and the First Postoperative Day||2 hours after surgery, on postoperative day 1|||percentage of participants|||Number
770963|NCT00721110|Secondary|Total Opioid Consumption at PACU Admission and Discharge as Well as Mornings of Postoperative Days 1 and 2||intraoperative through postoperative day 2|||milligram morphine sulfate equivalents||Inter-Quartile Range|Median
770964|NCT00721110|Secondary|Verbal Response Pain Scores (VRS) at PACU Admission and Discharge as Well as Mornings and Afternoons of Postoperative Days 1 and 2|Verbal response pain scores (VRS) at PACU admission and discharge as well as mornings and afternoons of postoperative days 1 and 2. VRS scale ranges from 0 to 10, with 0 denoting no pain and 10 denoting worst possible pain.|PACU admission and discharge, postoperative mornings and afternoons on days 1 and 2|||units on a scale||Standard Deviation|Mean
771365|NCT00723554|Primary|Number of Patients Reporting Treatment-emergent Serious AEs|Number of patients reporting at least one treatment-emergent serious AEs|From the first to last dose of investigational product, an average of approximately 268 days, plus 48 hours|Safety population||participants|||Number
770966|NCT00721123|Secondary|Percentage of Participants With at Least a 5-point Improvement From Baseline in Quality of Life Using the 36-Item Short-Form Health Survey (SF-36) Over Time, Through 264 Weeks|The SF-36 Health Survey is a standardized questionnaire consisting of 36 questions that measures patient-reported symptoms on 8 dimensions; it is used to assess health-related quality of life (HRQoL). The Physical Component Summary (PCS) score summarizes the subscales Physical Functioning, Role-Physical, Bodily Pain, and General Health. The Mental Component Summary (MCS) score summarizes the subscales Vitality, Social Functioning, Role-Emotional, and Mental Health. Each score was scaled from 0 to 100. A positive change score indicates better HRQoL. The percentage of participants with at least a 5-point improvement from baseline is presented for each subscale.|through 264 Weeks|All exposure population, which includes all participants who entered the study and received at least one dose of tocilizumab at any time, with a score at the given time point.||Percentage of Participants|||Number
770967|NCT00721123|Secondary|Percentage of Participants With at Least a 5-point Improvement From Baseline in Quality of Life Measure for Fatigue Over Time, Through 264 Weeks|"Quality of life is measured using the sub-scale for Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F). The assessment was originally developed for chronic illnesses and is now widely used for patients with rheumatoid arthritis.
FACIT-F is a 13-item questionnaire. Participants score each item on a 5-point scale: 0 (Not at all) to 4 (Very much), for a highest possible score of 52. The responses are transformed into a FACIT-F score, where a higher score reflects an improvement. The percentage of participants with at least a 5-point improvement from baseline in the Facit-F score is shown at categorical time points."|through 264 Weeks|All exposure population, which includes all participants who entered the study and received at least one dose of tocilizumab at any time, with a score at the given time point.||Percentage of Participants|||Number
770968|NCT00721123|Primary|Overall Death Rate Over Time|"Patient year (PY) refers to duration in study, calculated from first active drug intake to last safety assessment available + 1.
To calculate the death rate, the total cumulative number of years that all participants were exposed to the drug, from first active drug intake to last safety assessment available + 1, was calculated as 2461.94. Since 10 participants died during that time, the death rate per year was not informative (0.00). Therefore, the overall death rate was calculated with the confidence interval based on events per 100 patient years exposure."|through 264 Weeks|All exposure population, which included all participants who entered the study and received at least one dose of tocilizumab at any time.||Deaths per 100 PY||95% Confidence Interval|Number
770969|NCT00721123|Primary|Summary Adverse Event Rates Over Time|"Patient year (PY) refers to duration in study, calculated from first active drug intake to last safety assessment available + 1. Patient year rates with confidence interval were calculated for adverse events of interest in evaluating the long-term safety of the product being studied.
Abbreviations include the following: adverse event (AE), adverse event of special interest (AESI), gastrointestinal (GI), serious adverse event (SAE), and investigational product (IP). Hypersensitivity events were defined as AEs that occurred during or within 24 hours of IP infusion and were not deemed “unrelated” to trial treatment by the investigator. This definition includes all types of AEs, regardless of whether or not they were consistent with hypersensitivity.
Medical confirmation of the AESI GI perforation was based on medical adjudication of events captured by the GI Perforation Standardised MedDRA Queries (SMQs)."|through 264 Weeks|All exposure population, which includes all participants who entered the study and received at least one dose of tocilizumab at any time.||Adverse Events per 100 Patient Years||95% Confidence Interval|Number
770970|NCT00721123|Secondary|Change From Baseline in Scores for Patient's Level of Pain Over Time, Through 264 Weeks|The patient’s assessment of the patient's current level of pain on a 100 mm horizontal VAS was recorded. The extreme left end of the line was described as “no pain” and the extreme right end as “unbearable pain”. Change from baseline was calculated for given periods, and a negative change indicates improvement.|through 264 Weeks|All exposure population, which includes all participants who entered the study and received at least one dose of tocilizumab at any time, with a score at the given time point.||Units on a Scale||Standard Deviation|Mean
770971|NCT00721123|Secondary|Change From Baseline in Scores for Physician's Global Assessment of Disease Activity Over Time, Through 264 Weeks|Physician’s global assessment of disease activity is the treating physician’s assessment of the patient’s current disease activity on a 100 mm horizontal visual analogue scale (VAS). The extreme left end of the line was described as “no disease activity” (symptom-free and no arthritis symptoms) and the extreme right end as “maximum disease activity”. Change from baseline was calculated for given periods, and a negative change indicates improvement.|through 264 Weeks|All exposure population, which includes all participants who entered the study and received at least one dose of tocilizumab at any time, with a score at the given time point.||Units on a Scale||Standard Deviation|Mean
770972|NCT00721123|Secondary|Change From Baseline in Scores for Patient's Global Assessment of Disease Activity Over Time, Through 264 Weeks|Patient’s global assessment of disease activity is the patient’s overall assessment of their disease activity during specified time periods on a 100 mm horizontal visual analogue scale (VAS). The left-hand extreme of the line was described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme as “maximum disease activity” (maximum arthritis disease activity). Change from baseline was calculated for given periods, and a negative change indicates improvement.|through 264 Weeks|All exposure population, which includes all participants who entered the study and received at least one dose of tocilizumab at any time, with a score at the given time point.||Units on a Scale||Standard Deviation|Mean
770987|NCT00721149|Primary|Percentage of Subjects Who Exhibited no Documented Symptomatic Paroxysmal Atrial Fibrillation (PAF) Episodes From Study Day 91 Through Day 361.|A subject who exhibited no documented symptomatic PAF episodes was one who 1) had 2 or fewer repeat ablations within 90 days of the initial ablation with investigational catheter; 2) had an addition of antiarrhythmic medication which was previously ineffective for atrial fibrillation and did not exceed the previous historical maximum dosage (24 hour total dose); 3) was on atrioventricular nodal blocking agents such as beta blockers and/or calcium channel blockers and might be maintained at the current dose (ie, did not exceed previous historical maximum dosage (24 hour total dose).|From study day 91 through day 361|The subjects who had a study ablation procedure.||Percentage of participants|||Number
771571|NCT00727857|Secondary|Change From Baseline in Medium-Small Low Density Lipoprotein Concentration|The change between Medium-Small Low Density Lipoprotein collected at final visit or week 24 and Medium-Small Low Density Lipoprotein collected at baseline|Baseline and Week 24|||nmol/L||Standard Error|Least Squares Mean
770973|NCT00721123|Secondary|Change From Baseline in Scores for Health Assessment Questionnaire − Disability Index Over Time, Through 264 Weeks|"The Stanford Health Assessment Questionnaire - Disability Index (HAQ-DI) is a questionnaire specific for rheumatoid arthritis with 8 component sets (domains): dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Each domain has 2-3 questions (for a total of 20) that participants answer with categorical answers enumerated as a scale of 0-3, where 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do.
To calculate the HAQ-DI the patient must have a domain score for at least 6 of the eight domains. The HAQ-DI is the sum of the domain scores, divided by the number of domains that have a score (in range 6-8). The resulting HAQ-DI scores are on a scale that ranges from 0 to 3, where 0=lowest level of difficulty and 3=highest level of difficulty. A negative change from baseline indicates improvement."|through 264 Weeks|All exposure population, which includes all participants who entered the study and received at least one dose of tocilizumab at any time, with a score at the given time point.||Units on a Scale||Standard Deviation|Mean
770974|NCT00721123|Secondary|Change From Baseline in Scores for Swollen and Tender Joint Counts Over Time, Through 264 Weeks|"Swollen joint count (SJC) includes an assessment of 66 joints, and tender joint count (TJC) include an assessment of 68 joints. Joint prosthesis, arthrodesis or fused joints were not considered. Joints were assessed and classified as swollen/not swollen, and tender/not tender, by pressure and joint manipulation on physical examination. Change from Baseline in the SJC and TJC were calculated at given time points, and a negative change indicates improvement.
A small proportion of participants in the all-exposure population reduced or stopped their oral corticosteroid use due to sustained efficacy (defined as at least a 50% improvement in both swollen joint count (SJC) and tender joint count (TJC)."|through 264 Weeks|All exposure population, which includes all participants who entered the study and received at least one dose of tocilizumab at any time, with a score at the given time point.||Joints||Standard Deviation|Mean
770975|NCT00721123|Secondary|Percentage of Participants Classified as Responders by EULAR Response Over Time, Through 264 Weeks|Participants were classified as responders based on a European League Against Rheumatism (EULAR) response of Good or Moderate. Comparing the DAS28 from one patient on two different time points, it is possible to define improvement or response. The EULAR response criteria take into consideration both the first score and the change in score in order to classify them as good response, moderate response or no response. The percentage of participants who were classified as responders was recorded, as posted below.|through 264 Weeks|All exposure population, which includes all participants who entered the study and received at least one dose of tocilizumab at any time.||Percentage of Participants|||Number
770976|NCT00721123|Secondary|Percentage of Participants Classified as Responders by Disease Activity Scores Over Time, Through 264 Weeks|The disease activity score 28 (DAS28) is a combined index for measuring disease activity in rheumatic arthritis (RA) that includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The DAS28 scale ranges from 0 to 10, where lower scores represent less disease activity. Participants with DAS28 scores less than 2.6 were categorized as responders with remission and those with DAS 28 scores of 3.2 or less were categorized as responders with low disease activity (LDA). The percentage of participants classified as responders in each category was recorded over time.|through 264 Weeks|All exposure population, which includes all participants who entered the study and received at least one dose of tocilizumab at any time.||Percentage of Participants|||Number
770977|NCT00721123|Secondary|Participants Showing Improvement in Rheumatoid Arthritis Symptoms Over Time, Through 264 Weeks|"The American College of Rheumatology (ACR) established certain criteria to measure improvement in rheumatoid arthritis symptoms that include tender or swollen joint counts and five other criteria, including acute phase reactant, patient assessment, physician assessment, pain scale, and disability/functional questionnaire.
Clinical trials use the ACR Score, based on those criteria, as a standard for reporting different degrees of improvement in rheumatoid arthritis symptoms.
Scores on the ACR scale may be up to ACR100 because the number after “ACR” is the percent of improvement in tender or swollen joint counts as well as in three of the other five criteria. Clinical trials determine the percentage of participants who achieve that score – that percentage of improvement."|through 264 Weeks|All exposure population, which includes all participants who entered the study and received at least one dose of tocilizumab, with a score at the given time point.||Percentage of Participants|||Number
770978|NCT00721123|Primary|Adverse Event (AE) Summary Over Time|The number of participants experiencing at least one adverse event (AE) is recorded for each 12-month time period, with multiple occurrences in a single individual counted. Because months were calculated as 28 days, the periods actually equate to 48 weeks.|through 264 Weeks|All exposure population, which includes all participants who entered the study and received at least one dose of tocilizumab at any time.||Participants|||Number
770979|NCT00721136|Primary|Anticoagulant Related Complications|Defined as warfarin induced skin necrosis or heparin-induced thrombocytopenia|30 days|||participants|||Number
770980|NCT00721136|Primary|Thromboembolic Events||30 days|||participants|||Number
770981|NCT00721136|Primary|Bleeding Complication|Significant bleeding was defined as extracardiac bleeding or pocket hematomas that required additional intervention and/or temporary discontinuation of anticoagulation therapy.|30 days|Baseline characteristics of both groups were well matched except that patients randomized to warfarin discontinuation were more obese (P = .024).||participants|||Number
770982|NCT00721149|Secondary|Percentage of Subjects Who Responded to Quality of Life Assessment|SF 36 Symptom Frequency and Severity Checklist|1 year|Data not analyzed due to study termination – insufficient data to identify meaningful differences and draw significant conclusions.|||||
770983|NCT00721149|Secondary|TTM Data||1 year|Data not analyzed due to study termination – insufficient data to identify meaningful differences and draw significant conclusions.|||||
770984|NCT00721149|Secondary|24-hour Holter Data||1 year|Data not analyzed due to study termination – insufficient data to identify meaningful differences and draw significant conclusions.|||||
770985|NCT00721149|Secondary|Percentage of Subjects Who Achieved Acute Success|Acute success is defined as the confirmation of entrance block in all targeted pulmonary veins. Acute failure is defined as subjects who have a non-investigational catheter used for ablation of any atrial fibrillation targets or subjects who undergo more than 2 repeat ablation procedures or an ablation procedure beyond day 90.|Day 91 - 361|The subjects who had a study ablation procedure.||Percentage of participants|||Number
770988|NCT00721162|Secondary|Summary Listing of Participants Reporting Drug-Related Treatment-Emergent Adverse Events|Data presented are the number of participants who experienced treatment-emergent adverse events (TEAE), serious adverse events (SAE), Grade 3 or 4 TEAE, or adverse events (AE) leading to discontinuation of treatment that were considered to be related to ramucirumab. A summary of SAEs and other nonserious AEs, regardless of causality, is located in the Reported Adverse Events section.|First dose to 30 months|All participants who received any amount of study drug.||participants|||Number
770989|NCT00721162|Secondary|Overall Survival (OS)|Overall survival is defined as the time from first dose to the date of death due to any cause. For participants who were alive or were lost to follow-up, overall survival was censored on the last date the participant was known to be alive.|First dose to death due to any cause up to 43.9 months|All participants who received any amount of study drug. The number of participants censored was 12.||months||95% Confidence Interval|Median
770990|NCT00721162|Secondary|Overall Survival at 1 Year (OS-1)|Data presented are the percentage of participants surviving at least 12 months after first dose based on Kaplan Meier Method.|First dose to 12 months|All participants who received any amount of study drug.||percentage of participants||95% Confidence Interval|Number
770991|NCT00721162|Secondary|Progression-Free Survival (PFS)|Defined as the time from date of first dose to the first observation of progression of disease (PD) or death due to any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. PD is ≥20% increase in sum of longest diameter of target lesions and/or unequivocal progression of non-target lesion and/or new lesion. For participants who had no PD or death or had started new therapeutic anticancer treatment, PFS was censored at their last radiographic tumor assessment.|First dose to measured progressive disease or death due to any cause up to 34.6 months|All participants who received any amount of study drug. The number of participants censored was 11.||months||95% Confidence Interval|Median
770992|NCT00721162|Primary|Objective Response Rate (ORR): Percentage of Participants With Complete Response (CR) and Partial Response (PR)|Objective response is confirmed complete response (CR) + partial response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesion. ORR is calculated as a total number of participants with CR or PR from the start of study treatment until disease progression/recurrence or the start of new therapeutic anticancer treatment, whichever occurred first, divided by the total number of participants treated, then multiplied by 100.|First dose to date of objective progressive disease /death or new anti-cancer therapy up to 34.6 months|All participants who received any amount of study drug.||percentage of participants||95% Confidence Interval|Number
770993|NCT00721162|Primary|Percentage of Participants With Progression-Free Survival at 6 Months (PFS-6)|Data presented are the percentage of participants without progressive disease (PD) or death from any cause at 6 month after first dose. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. PD is ≥20% increase in sum of longest diameter of target lesions and/or unequivocal progression of non-target lesion and/or new lesion.|First Dose to 6 Months|All participants who received any amount of study drug.||percentage of participants||95% Confidence Interval|Number
770994|NCT00721175|Primary|Proportion of Patients With Adequate Biliary Drainage in Metallic Stent and Plastic Stent Group.(Per Protocol Analysis)|Successful drainage was defined as a decrease in total bilirubin level to less than 30% or 50% of pretreatment level within two and four weeks respectively.|at 2 weeks and 4 weeks after stent insertion|91 participants who had successful stent insertion were analyzed based on per protocol analysis.||proportion of participants||95% Confidence Interval|Mean
770995|NCT00721175|Secondary|Cost Effective Ratio of Metallic and Plastic Stent|cost per quality adjusted life year (QALY)of metallic stent and plastic stent calculated from Markov model using transitional probabilities, cost and utilities from this study and the available literature|until the patients expire (Markov model)|Simulation cohort of any number of the patients (1, 100 or 1,000 patients) enter the Markov model using transitional probabilities, cost data, utility data from this study and available literature to calculate the cost effectiveness ratio of metallic stent and plastic stent in unresectable complex hilar cholangiocarcinoma||cost (US$) per QALY|||Number
770996|NCT00721175|Secondary|Patients Survival Times|survival times of the patients after the first stent insertion|until patient died or 6 months after the last patient was enrolled|||days||Inter-Quartile Range|Median
770997|NCT00721175|Primary|Proportion of Patients With Adequate Biliary Drainage in Metallic Stent and Plastic Stent Group.(ITT Analysis)|Successful drainage was defined as a decrease in total bilirubin level to less than 30% or 50% of pretreatment level within two and four weeks respectively in each patient.|at 2 weeks and 4 weeks after stent insertion|All 108 participants enrolled into the study were analyzed based on ITT analysis basis.(54 participants in each group)||proportion of participants||95% Confidence Interval|Mean
770998|NCT00721188|Secondary|Number of Participants With Serious Adverse Events (SAE's)||Day of initial treatment with Venofer through 30 days after study treatment|||participants|||Number
770999|NCT00721188|Secondary|Mean Residence Time (MRtime)||Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.|||hour||Standard Deviation|Mean
771000|NCT00721188|Secondary|Volume of Distribution at Steady State (Vdss)||Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.|||dL||Standard Deviation|Mean
771001|NCT00721188|Secondary|Volume of Distribution Based on the Terminal Phase (Vdarea)||Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.|||dL||Standard Deviation|Mean
771002|NCT00721188|Secondary|Initial Volume of Distribution (Vdc)||Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.|||dL||Standard Deviation|Mean
771003|NCT00721188|Secondary|Total Body Clearance (Cl)|Total body clearance: Cl = Dose/Area Under the Serum Concentration-time Curve Extrapolated to Infinity (AUC 0-∞)|Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours.|||dL/hour||Standard Deviation|Mean
771004|NCT00721188|Primary|Terminal Phase Elimination Rate Constant (λz)||Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.|||1/hour||Standard Deviation|Mean
771010|NCT00715559|Secondary|Systematic Assessment for Treatment Emergent Effects (SAFTEE)|"The SAFTEE is used to measure somatic and other symptoms which may arise during the course of a clinical trial. This is a non-quantitative instrument that does not yield a numeric score. Instead, it provides study subjects the opportunity to check off symptoms listed on a checklist and indicate if the severity of the symptoms is mild moderate or severe. The reported values represent symptoms that were indicated at any point during the 8 week trial at a level of moderate or severe that also represented a change from a baseline-line pre-intervention SAFTEE assessment."|weekly, for 8 weeks|Study participants were assessed for side effects or adverse events with the SAFTEE at each study visit over the 8 week trial.||symptoms||Standard Deviation|Mean
771011|NCT00715559|Secondary|Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR16)|This is a self-report which measures the level of depression severity. I ranges from 0 (no illness) to 27 (severe illness).|8 weeks|||scale score||Standard Deviation|Mean
771012|NCT00715559|Secondary|Clinical Global Impression Scales for Severity (CGI-S) and Improvement (CGI-I)|"This set of scales measures global improvement in a patient's level of symptoms, without reference to a particular condition (ie depression). GCI-S is a measure of severity, which ranges from 0 (not ill) to 7 (severely ill). CGI-I is a measure of change, with a score of 4 indicating no change, 1 indicating very much improved and 7 indicating very much worse."|8 weeks|||scale score||Standard Deviation|Mean
771013|NCT00715559|Primary|Montgomery-Åsberg Depression Rating Scale (MADRS)|This scale measures depression severity. It ranges from a score of 0 to 60, with higher score indicating higher level of depression severity.|8 weeks|Mean MADRS score at end of treatment (LOCF) in 3 participants treated with cysteamine bitartrate.||scale score||Standard Deviation|Mean
771014|NCT00715624|Other Pre-specified|Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia|Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the patient required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.|First dose of study drug up to 3 days after the last dose administration for up to 125 weeks|Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.||participants|||Number
771015|NCT00715624|Other Pre-specified|Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.||percentage of participants|||Number
771016|NCT00715624|Other Pre-specified|Change From Baseline in Glucose Excursion at Week 24|Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the standardized meal test, before study drug administration. Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline glucose excursion assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
771017|NCT00715624|Secondary|Percentage of Patients Requiring Rescue Therapy During Main 24-Week Period|Routine fasting SMPG and central laboratory FPG (and HbA1c after week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after week 12) were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG >270 milligram/deciliter (mg/dL) (15.0 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 24: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c > 8.5%. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline up to Week 24|mITT population.||percentage of participants|||Number
771018|NCT00715624|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.||percentage of participants|||Number
771019|NCT00715624|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.||percentage of participants|||Number
771034|NCT00715676|Secondary|Percent Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at Week 52|Percent change in femoral neck BMD (relative to baseline) at Week 52|Baseline and Week 52|This analysis was performed on the Full Analysis Set, which included all subjects who received at least one dose of study drug. Multiple imputation was used for missing data.||Percent change||Standard Deviation|Mean
771020|NCT00715624|Secondary|Change From Baseline in Total Insulin Dose at Week 24|Change was calculated for total insulin dose by subtracting the baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline total insulin dose assessment during on-treatment period.||units per day||Standard Error|Least Squares Mean
771021|NCT00715624|Secondary|Change From Baseline in Body Weight at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.||kilogram||Standard Error|Least Squares Mean
771022|NCT00715624|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline FPG assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
771023|NCT00715624|Secondary|Change From Baseline in Average 7-Point Self Monitored Plasma Glucose (SMPG) Profiles at Week 24|Patients recorded a 7-point plasma glucose profile measured before and 2 hours after each meal and at bedtime once in a week and the average value for the 7-time points was calculated. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline 7-point SMPG assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
771024|NCT00715624|Secondary|Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Week 24|The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using last observation carried forward (LOCF). Here, number of patients analyzed = patients with baseline and at least 1 post-baseline 2-hour PPG assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
771025|NCT00715624|Primary|Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|Absolute change = HbA1c value at Week 24 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population:all randomized patients who received at least 1 dose;had baseline,at least 1 post-baseline efficacy assessment, irrespective of compliance with study protocol/procedures. LOCF was used. Number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.||percentage of hemoglobin||Standard Error|Least Squares Mean
771026|NCT00715650|Primary|Days of Work and Work-related Activity|Number of days in the past 28 spent engaged in any kind of work or related activity. Measured using a timeline follow-back calendar.|Month 6|||days||Standard Deviation|Mean
771027|NCT00715650|Primary|Days of Work and Work-related Activity|Number of days in the past 28 spent engaged in any kind of work or related activity. Measured using a timeline follow-back calendar.|Month 3|||days||Standard Deviation|Mean
771028|NCT00715650|Primary|Days of Work and Work-related Activity|Number of days in the past 28 spent engaged in any kind of work or related activity. Measured using a timeline follow-back calendar.|Month 1|||days||Standard Deviation|Mean
771029|NCT00715650|Primary|Days of Work and Work-related Activity|Number of days in the past 28 spent engaged in any kind of work or related activity. Measured using a timeline follow-back calendar.|Baseline|||days||Standard Deviation|Mean
771030|NCT00715676|Secondary|Number of Subjects With at Least 1 Treatment-emergent Adverse Event|To assess safety and tolerability, the number of subjects in each treatment group who had one or more adverse events recorded after the beginning of study drug administration were determined.|1 year|The participants for this analysis included all randomized subjects who received a dose of study drug.||Participants|||Number
771031|NCT00715676|Secondary|Percent Change From Baseline in Serum Bone Markers at Week 26|Percent change from baseline at Week 26|Baseline and Week 26|Analyses were performed using subjects for whom both Baseline and Week 26 samples were available.||Percent change||Standard Deviation|Mean
771032|NCT00715676|Secondary|Change From Baseline in Serum Calcium Levels at Week 52|Change in serum calcium value (relative to baseline) at Week 52|Baseline and Week 52|This analysis was done for all subjects for whom both baseline and Week 52 data was available.||mg/dL||Standard Deviation|Mean
773263|NCT00730353|Secondary|Progression-Free Survival|To determine the time to progression for the combination of sunitinib malate and paclitaxel in advanced esophageal carcinoma per RECIST criteria.|12 months|Intention-to-treat patients||Days||90% Confidence Interval|Median
771035|NCT00715676|Secondary|Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 52|The percent change in hip BMD (relative to baseline) at Week 52|Baseline and Week 52|This analysis was conducted on the Full Analysis Set, which included all randomized subjects who received at least one dose of study drug. Multiple imputation was used for missing data.||Percent Change||Standard Deviation|Mean
771036|NCT00715676|Primary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 52|Percent change in lumbar spine BMD (relative to baseline) at Week 52|Baseline and Week 52|This analysis was performed on the Full Analysis Set, which included all subjects who received at least one dose of study drug. Multiple imputation was used for missing data.||Percent change||Standard Deviation|Mean
771037|NCT00721214|Secondary|Two-year Event-free Survival From Time of Treatment Initiation With 5-Azacytidine for All Study Cohorts|Percentage of participants with two year event free survival after their first treatment was estimated by the Kaplan-Meier survival curve. The events analyzed are evidence of molecular, cytogenetic or histologic relapse or death from any cause. Patients alive at the time of last observation will be censored.The estimated two- year event-free survival rate is the same as for overall survival, 37% (SE = 14.3%).|2 years|Intent to treat analysis including patients who consented and were eligible. Patients enrolled in the study having received at least one 28 day cycle of 5-Azacytidine. As well as engraftment of white blood cells and platelets, graft failure, relapse and Graft Versus Host Disease (GVHD) will be considered in the intent-to-treat analysis.||percentage of participants||95% Confidence Interval|Number
771038|NCT00721214|Secondary|One-year Event-free Survival From Time of Treatment Initiation With 5-Azacytidine for All Study Cohorts|Percentage of participants with one year event free survival after their first treatment was estimated by the Kaplan-Meier survival curve. The events analyzed are evidence of molecular, cytogenetic or histologic relapse or death from any cause. Patients alive at the time of last observation will be censored.The estimated one-year event-free survival rate is the same as for overall survival, 47% (SE = 13.6%).|1 year|Intent to treat analysis including patients who consented and were eligible. Patients enrolled in the study having received at least one 28 day cycle of 5-Azacytidine. As well as engraftment of white blood cells and platelets, graft failure, relapse and Graft Versus Host Disease (GVHD) will be considered in the intent-to-treat analysis.||percentage of participants||95% Confidence Interval|Number
771039|NCT00721214|Secondary|Two-year Overall Survival From Time of Treatment Initiation With 5-Azacytidine for All Study Cohorts.|Percentage of participants alive two years after their first treatment was estimated by the Kaplan-Meier survival curve. The events analyzed are evidence of molecular, cytogenetic or histologic relapse or death from any cause. Patients alive at the time of last observation will be censored.The estimated two year survival rate is 37% .The estimated two-year overall survival rate is the same as two-year event free survival.|2 years|Intent to treat analysis including patients who consented and were eligible. Patients enrolled in the study having received at least one 28 day cycle of 5-Azacytidine. As well as engraftment of white blood cells and platelets, graft failure, relapse and Graft Versus Host Disease (GVHD) will be considered in the intent-to-treat analysis.||percentage of participants||95% Confidence Interval|Number
771040|NCT00721214|Primary|Two Year Event Free Survival (EFS) for Allogeneic Transplant Recipients After Transplantation|Percentage of participants that received allogeneic transplant and had event free survival. The percentage of patients was estimated by the Kaplan-Meier survival curve. The events analyzed are evidence of molecular, cytogenetic or histologic relapse or death from any cause. The estimated two-year event-free survival rate is the same as overall survival, 50%.|2 years|Patients surviving after stem cell infusion will be considered in the transplantation cohort; those dying or relapsing prior to this event are considered to have progressed. Outcomes of 5-Axacytidine responders and non-responders will be compared. Patients alive at the time of last observation will be censored.||percentage of participants||95% Confidence Interval|Number
771041|NCT00721214|Primary|One Year Event Free Survival (EFS) for Allogeneic Transplant Recipients After Transplantation|Percentage of participants that received allogeneic transplant and had event free survival, as estimated by the Kaplan-Meier survival curve. The events analyzed are evidence of molecular, cytogenetic or histologic relapse or death from any cause. The estimated one-year event-free survival rate is the same as overall survival, 50%.|1 year|Patients surviving after stem cell infusion will be considered in the transplantation cohort; those dying or relapsing prior to this event are considered to have progressed. Outcomes of 5-Axacytidine responders and non-responders will be compared. Patients alive at the time of last observation will be censored.||percentage of participants||95% Confidence Interval|Number
771042|NCT00721214|Primary|Two Year Overall Survival of Allogeneic Transplant Recipients After Transplantation|Percentage of patients alive two years after their transplantation, as estimated by the Kaplan-Meier survival curve. The estimated two year survival rate is 50%, the same as one year survival rate.|2 years|Patients surviving after stem cell infusion will be considered in the transplantation cohort; those dying or relapsing prior to this event are considered to have progressed. Outcomes of 5-Axacytidine responders and non-responders will be compared. Patients alive at the time of last observation will be censored.||percentage of participants||95% Confidence Interval|Number
771043|NCT00721214|Secondary|One-year Overall Survival From Time of Treatment Initiation With 5-Azacytidine for All Study Cohorts|Percentage of participants alive one year after their first treatment was estimated by the Kaplan-Meier survival curve. The events analyzed are evidence of molecular, cytogenetic or histologic relapse or death from any cause. Patients alive at the time of last observation will be censored. The estimated one year overall survival rate from this curve is 47%. The one year overall survival is the same as one year event free survival rate.|1 year|Intent to treat analysis including patients who consented and were eligible. Patients enrolled in the study having received at least one 28 day cycle of 5-Azacytidine. As well as engraftment of white blood cells and platelets, graft failure, relapse and Graft Versus Host Disease (GVHD) will be considered in the intent-to-treat analysis.||percentage of participants||95% Confidence Interval|Number
771044|NCT00721214|Primary|One Year Overall Survival of Allogeneic Transplant Recipients After Transplantation|Percentage of patients alive one year after their transplantation, as estimated by the Kaplan-Meier survival curve. The estimated one year survival rate from this curve is 50%, while the estimated two year survival rate is 50%.|1 year|Patients surviving after stem cell infusion will be considered in the transplantation cohort; those dying or relapsing prior to this event are considered to have progressed. Outcomes of 5-Axacytidine responders and non-responders will be compared. Patients alive at the time of last observation will be censored.||percentage of participants||95% Confidence Interval|Number
771045|NCT00721227|Secondary|Weight Loss Following Reduction Gastroplasty|Percentage of excess weight loss calculated at 12 months post-surgery. Percentage of excess weight loss is calculated is the difference in baseline and post-surgery weight divided by the difference in baseline weight and ideal body weight multiplied by 100.|12 months|Includes only participants who completed month 12 visit.||Percentage of weight loss||Standard Deviation|Mean
771046|NCT00721227|Secondary|Durability of Gastric Plications Following Reduction Gastroplasty|The number of participants who completed month 12 gastroscopies showing intact plications.|12 month|Includes only participants who completed month 12 gastroscopy.||participants|||Number
771047|NCT00721227|Primary|Successful Gastric Plication Using Reduction Gastroplasty|The number of participants who completed the study and had post-opeartive gastrocopies showing intact plications.|Immediately post-operative|||participants|||Number
771048|NCT00721253|Secondary|Defocus Curve|Defocus cureve. A defocus curve is created by multiple measurements of one's visual acuity at different spherical powers. Visual Acuity (VA) is measured in logMAR. LogMAR is the “logarithm of the minimum angle of resolution”. A lower logMAR value indicates better visual acuity.|6 months post-operative|||logMAR||Standard Deviation|Mean
771049|NCT00721253|Secondary|Contrast Sensitivity|Contrast sensitivity is the measurement of one's ability to detect slight changes in luminance before it becomes indistinguishable. It is measured in logarithmic units by means of an illuminated box, the CSV 1000 by Vector Vision. A higher value for the logarithmic units translates to better contrast sensitivity.|6 months|||log units||Standard Deviation|Mean
771050|NCT00721253|Primary|Uncorrected Visual Acuity (UCVA) at Distance, Near and Intermediate|Uncorrected Visual Acuity (UCVA) at distance, near and intermediate, measured in logMAR. LogMAR is the “logarithm of the minimum angle of resolution”. It is a unit of measure for visual acuity (VA). A lower logMAR value indicates better visual acuity.|6 months|||logMAR||Standard Deviation|Mean
771051|NCT00721279|Primary|Correlation of the Change in IRLS at End of Titration and at Final Visit|Correlation of the change in IRLS at end of titration and at final visit|Up to 12 weeks|Full Analysis Set (FAS)||percentage of patients|||Number
771052|NCT00721279|Primary|Frequency of Adverse Events|Frequency of patients with any adverse event, causally related adverse events and serious adverse events|Up to 16 weeks|Safety Analysis Set (SAF)||participants|||Number
771053|NCT00721279|Primary|Change in Global Clinical Impression - Improvement (CGI-I) Scale|The Clinical Global Impression Improvement scale (CGI-I) requires the clinician to rate how much the patient’s illness has improved or worsened relative to a baseline state. A patient’s illness is compared to change over time and rated as: very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse|baseline and final visit (week 12)|Full analysis set||percentage of participants|||Number
771054|NCT00721279|Primary|Change in Total Scores of IRLS (International Restless Legs Rating Scale)|"The International Restless Legs Syndrome Rating Scale (IRLS) is a rating scale used to assess the severity of RLS symptoms. The IRLS consists of 10 items, each of which is rated from 0 to 4 points, higher values denoting an increased severity of symptoms. Maximum total score is 40. Score totals are grouped into four levels of severity: 1-10 points = mild RLS, 11-20 points = moderate RLS, 21-30 points = severe RLS, and 31-40 = very severe RLS.
The change from baseline was calculated as baseline minus the week 12 value."|Baseline and final visit (week12)|Only those patients of the full analysis set with an evaluation of the IRLS at visit 3 were included||scores on a scale||Inter-Quartile Range|Median
771055|NCT00721279|Primary|Frequency Analysis for Baseline Pattern of RLS Symptoms|Severity of RLS was rated using the International RLS Severity Scale. This scale measures the severity of RLS symptoms and comprises of 10 questions with 5 possible answers, each answer scored from 0-4 points and is classified into 5 RLS severity groups: 0 points = no symptoms, 1-10 points = mild, 11-20 points = moderate, 21-30 points = severe, 31-40 points = very severe.|Baseline|Full analysis set (FAS)||percentage of participants|||Number
771056|NCT00721357|Secondary|Magnetic Resonance Spectroscopy of Muscle Metabolic Properties||within one week of enrollment||||||
771057|NCT00721357|Secondary|Muscle Mechanical Energy Expenditure|mechanical work done by lower extremity joints|one time measure||12/2015||||
771058|NCT00721357|Primary|Oxygen Consumption During Walking|Amount of oxygen consumed during walking at self-selected speed normalized to speed|within one week of enrollment|||ml/kg/min||Standard Deviation|Mean
771059|NCT00721396|Secondary|Non-inferiority of Immune Response to Acellular Pertussis Antigens When Routine Vaccines Are Administered Concomitantly With rMen+OMV NZ Vaccine.|"Non-inferiority of immune response to routine vaccine antigens when routine vaccines were administered concomitantly with rMenB+OMV NZ vaccine [group B+R234] to when only routine vaccines were given [Group R234] were assessed in terms of percentage of subjects achieving seroconversion for pertussis antigens - Filamentous Hemagglutinin (FHA), Pertactin and Pertussis Toxoid (PT) at 1 month after 3rd vaccination versus baseline.
Seroconversion was defined as a 4-fold increase for each pertussis antigen or in those initially seropositive, persistence of the pre-vaccination antibody concentration at least at the same antibody concentration as before vaccination, taking into account the decay of maternal antibodies."|1 month after 3rd vaccination|||Percentages of subjects||95% Confidence Interval|Number
771060|NCT00721396|Secondary|Percentage of Subjects With 4-fold Rise in hSBA Titers, When rMenB+OMV NZ Vaccine is Administered Concomitantly With Routine Infant Vaccines.|The percentage of subjects with 4-fold rise in hSBA titers at 1 month after 3rd rMenB+OMV NZ vaccination from baseline, when rMenB+OMV NZ was administered concomitantly with routine infant vaccines to when rMenB+OMV NZ vaccine and routine vaccines were given separately.|One month after third Men B vaccination|PP Population||Percentages of subjects||95% Confidence Interval|Number
771061|NCT00721396|Secondary|Percentage of Subjects With hSBA ≥1:8 After Receiving Three Doses of rMenB+OMV NZ Vaccine.|The percentage of subjects with hSBA titers ≥1:8, following rMenB+OMV NZ vaccination when given concomitantly with routine infant vaccines to when rMenB+OMV NZ and routine vaccines were given separately.|One month after third Men B vaccination|PP Population||Percentages of subjects||95% Confidence Interval|Number
771062|NCT00721396|Secondary|Geometric Mean Ratio of hSBA Titers, When rMenB+OMV NZ Vaccine is Administered Concomitantly With Routine Infant Vaccines.|The geometric mean ratio(GMR) of GMTs at 1 month after 3rd rMenB+OMV NZ vaccination to prevaccination GMTs, when rMenB+OMV NZ was administered concomitantly with routine infant vaccines to when rMenB+OMV NZ vaccine and routine vaccines were given separately.|one month after third Men B vaccination|PP Population||Ratio||95% Confidence Interval|Geometric Mean
771063|NCT00721396|Secondary|Geometric Mean Titers Against Neisseria Meningitidis Serogroup B, When rMenB+OMV NZ Vaccine is Administered Concomitantly With Routine Infant Vaccines.|The hSBA antibody titers when rMenB+OMV NZ vaccine is administered concomitantly with routine infant vaccines to when rMenB+OMV NZ vaccine and routine vaccines were given separately are reported in terms of vaccine-group-specific geometric mean titers.|One month after third Men B vaccination|PP Population||Titers||95% Confidence Interval|Geometric Mean
771064|NCT00721396|Secondary|Non-inferiority of Immune Response to Diphtheria and Tetanus Antigens When Routine Vaccines Are Administered Concomitantly With rMen+OMV NZ Vaccine|Non-inferiority of immune response to routine vaccine antigens when routine vaccines were administered concomitantly with rMenB+OMV NZ vaccine [group B+R234] to when only routine vaccines were given [Group R234] were assessed in terms of percentage of subjects with antibody concentrations ≥0.1 IU/mL against Diphtheria and Tetanus antigens as measured by enzyme-linked immunosorbent assay.|One month after 3rd vaccination|All subjects in the Full Analysis Set/MITT population who received all the relevant doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to analysis: Per Protocol (PP) Population.||Percentages of subjects||95% Confidence Interval|Number
771065|NCT00721396|Secondary|Non-inferiority of Immune Response to rMenB+OMV NZ Vaccination When Administered Concomitantly With Routine Infant Vaccines at 2,4,6 Months of Age|The non-inferiority of immune response to rMenB+OMV NZ vaccination when administered concomitantly with routine infant vaccines at 2,4,6 months of age(B+R246) to when rMenB+OMV NZ and routine vaccines were administered separately (group B246_R357)was assessed in terms of percentage of subjects With hSBA≥ 1:5.|One month after 3rd Men B vaccination|Analysis was done on the per-protocol population i.e all subjects in the MITT population who received all the relevant doses of vaccine correctly, provided evaluable serum samples at the relevant time points and had no major protocol violation as defined prior to analysis.||Percentages of subjects||95% Confidence Interval|Number
771066|NCT00721396|Primary|Safety and Tolerability of 3 Doses of rMenB - Concomitantly With Routine Infant Vaccines at 2, 4 and 6 Months of Age - Concomitantly With Routine Vaccines at 2, 3 and 4 Months of Age - Alone at 2, 4 and 6 Months of Age|Safety and Tolerability of 3 Doses of rMenB was assessed in terms of the number of subjects who reported solicited local and systemic adverse events when administered concomitantly with routine infant vaccines at 2,4,6 months of age (B+R246) to when rMenB+OMV NZ and routine vaccines were administered separately (group B246_R357).|10 months (groups 1 and 2); 8 months (groups 3 and 4)|All subjects receiving at least one injection and providing post-baseline safety data (Safety Set).||Number of subjects|||Number
771067|NCT00721396|Primary|Percentage of Subjects With Serum Bactericidal Activity ≥1:5 After Receiving Three Doses of rMenB+OMV NZ Vaccine|"The percentage of subjects with serum bactericidal activity(hSBA)titer ≥1:5 after receiving three doses of rMenB+OMV NZ vaccine were evaluated to demonstrate sufficient immune response following rMenB+OMV NZ vaccination, when given concomitantly with routine infant vaccines to healthy infants.
The serum bactericidal antibodies directed against serogroup B meningococci, are measured by human complement Serum Bactericidal Assay (hSBA).
The immune response was considered sufficient for groups B+R246 and B+R234 if the lower limit of the 2-sided 95% confidence interval was ≥ 70% for all three strains."|One month after third Men B vaccination|The analysis was done on the Modified Intention to Treat (MIIT) population, ie, enrolled subjects who actually received a study vaccination and provided at least one evaluable serum sample after baseline.||Percentages of subjects||95% Confidence Interval|Number
771112|NCT00721734|Secondary|Plasma Protein Binding (PPB) of Carfilzomib|The plasma protein binding (PPB) of carfilzomib in plasma samples was determined using a rapid equilibrium dialysis (RED) device. Data are averages of the 3 time points (Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 15).|End of injection and 5 minutes post-dose on Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 15|Participants with available data||percentage of carfilzomib bound||Standard Deviation|Mean
771113|NCT00721734|Secondary|Percentage of Carfilzomib Metabolites Excreted Via Renal Elimination on Day 15 of Cycle 1|The percentage of the metabolites of carfilzomib (PR-389/M14 and PR-413/M15) excreted in urine was calculated as the total amount excreted over 24 hours/dose.|Cycle 1, Day 15, 0-5 and 5-24 hours post-dose|Participants in Groups 1-4 with available data||percentage of carfilzomib dose||Standard Deviation|Mean
771099|NCT00721500|Primary|Lens Tightness on Cornea With Manual Digit Push Up|Lens tightness on push-up assessed by digital push-up test (gentle push of the lens upward using the lower lid) with eye in primary gaze position and observing ease of push-up and speed of return to original position. Tightness is measured on a 0%-100% continuous scale where 0%=falls from cornea without lid support, 50%=optimum and 100%=no movement.|Within 20 minutes of lens insertion|Participants who were enrolled and completed the study.||percentage|Participants|Standard Deviation|Mean
771100|NCT00721500|Primary|Lens Fit Decentration|Lens centration was assessed in primary gaze, diffuse white light, low-medium magnification, with graticule. Lens fit decentration with respect to visible cornea was measured to nearest 0.1mm.|Within 20 minutes of lens insertion|Participants who were enrolled and completed the study.||mm|Participants|Standard Deviation|Mean
771101|NCT00721500|Primary|Proportion of Eyes Successfully Fit|Overall lens fit acceptance was assessed by the Investigator based on lens fit alone in a 6-level scale; 0=should not be worn, 1=should not be dispensed although no immediate danger, 2=borderline but unacceptable, 3=minimal acceptable, early review, 4=not perfect but OK to dispense and 5=perfect. Lens fitting responses >2 were considered 'successful fit' while the rest of responses were considered 'unsuccessful fit'.|Within 20 minutes of lens insertion|Participants who were enrolled and completed the study.||proportion of participant eyes|Participants||Number
771102|NCT00721539|Secondary|Average Operative Time|Average operative time in minutes|Up to four hours (240 minutes)|Participants||Minutes||Full Range|Mean
771103|NCT00721539|Secondary|Average Blood Loss|Blood lost during procedure|Duration of procedure up to two hours|Participants||mL||Full Range|Mean
771104|NCT00721539|Secondary|Feasibility Defined as Ability to Perform the Planned Diagnostic or Therapeutic Procedure||Six weeks|Adult patients 18 years of age and over||Participants|||Number
771105|NCT00721539|Primary|Overall Complication Rate (Intraoperative and Postoperative)|Complications encountered intraoperatively or up to six weeks postoperatively. This would include injury to patient, hemorrhage, lacerations, and readmission following surgery.|Six weeks|Subjects enrolled in this pilot study.||Participants|||Number
771106|NCT00721630|Secondary|Number of Participants With Toxicities Associated With Capecitabine and Lapatinib|Toxicities evaluated according to NCI CTC v.3|6 months|||Participants|||Count of Participants
771107|NCT00721630|Primary|Estimate Efficacy of Capecitabine 7/7 in Combination With Lapatinib in Patients With HER2 Overexpressed/Amplified, Trastuzumab-refractory, Metastatic Breast Cancer as Determined by Overall Response Rate (Complete Response (CR) + Partial Response (PR))|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|6 months|||Participants|||Count of Participants
771108|NCT00721734|Secondary|Time to Progression (TTP)|Time to Progression is defined as the time from first dose of carfilzomib to disease progression. Median TTP was estimated using Kaplan-Meier methods.|Participants were followed for disease progression for up to 2 years.|Response Evaluable Population||months||95% Confidence Interval|Median
771109|NCT00721734|Secondary|Duration of Response|"Duration of Response is defined as the time from first evidence of PR or better to confirmation of disease progression or death.
Progressive disease was defined as any of the following:
An increase of more than 25% from nadir in any one of the following:
M-protein in serum (the absolute increase had to be ≥ 0.5 g/dL);
Urine (the absolute increase had to be ≥ 200 mg/24 hours);
The difference between involved and uninvolved sFLC (the absolute increase in the concentration of involved light chain had to be > 10 mg/dL);
≥ 10% bone marrow infiltration by plasma cells;
Increased size of pre-existing bone lesions or plasmacytomas or new bone lesions or plasmacytomas.
Median duration of response was estimated using the Kaplan-Meier method."|Participants were followed for disease progression for up to 2 years.|Response Evaluable Population with a best overall response of sCR, CR, VGPR, or PR.||months||95% Confidence Interval|Median
771110|NCT00721734|Secondary|Clinical Benefit Rate (CBR)|Clinical benefit rate is defined as the percentage of participants whose best response was sCR, CR, VGPR, PR, or minimal response (MR), where MR is defined by the European Group for Blood and Marrow Transplant (EBMT) criteria as a reduction of M-protein in serum of 25% to 49% and in urine of 50% to 89% from baseline, maintained for at least 6 weeks.|From first dose until 30 days after the last dose; median duration of treatment across all groups was 121 days.|The response evaluable population||percentage of participants||95% Confidence Interval|Number
771111|NCT00721734|Secondary|Overall Response Rate (ORR)|"ORR is defined as the percentage of participants with a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) per the International Uniform Response Criteria for Multiple Myeloma.
sCR: CR as defined below plus normal serum free light chain (sFLC) ratio and absence of clonal plasma cells in bone marrow by immunohistochemistry or immunofluorescence; CR: absence of M-protein in serum and urine confirmed by immunofixation and < 5% plasma cells in the bone marrow; VGPR: serum and urine M-proteins detectable by immunofixation, but not by electrophoresis or a ≥ 90% reduction in serum M-protein from baseline, plus a urine M-protein level of < 100 mg/24 hours; PR: reduction of M-protein in serum of ≥ 50% and in urine of ≥ 90% from baseline. If serum and urine M-protein were not measureable at baseline, a ≥ 50% decrease in the difference between involved and uninvolved sFLC levels from baseline."|From first dose until 30 days after the last dose; median duration of treatment across all groups was 121 days.|The response evaluable population included all participants with measurable disease and a baseline and at least 1 post-baseline disease assessment or who discontinued study treatment due to a related adverse event prior to obtaining an on-study disease assessment.||percentage of participants||95% Confidence Interval|Number
778141|NCT00774163|Secondary|Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Vomiting Reported||Day 0 through 6 weeks after Day 0|||days with symptom reported|Days of observation||Number
771114|NCT00721734|Secondary|Percentage of Carfilzomib Metabolites Excreted Via Renal Elimination on Day 1 of Cycle 1|The percentage of the metabolites of carfilzomib (PR-389/M14 and PR-413/M15) excreted in urine was calculated as the total amount excreted over 24 hours/dose.|Cycle 1, Day 1, 0-5 and 5-24 hours post-dose|Participants in Groups 1-4 with available data||percentage of carfilzomib dose||Standard Deviation|Mean
771115|NCT00721734|Secondary|Percentage of Carfilzomib Excreted Via Renal Elimination on Day 15 of Cycle 1|The percentage of carfilzomib excreted in urine was calculated as the total amount excreted over 24 hours/dose.|Cycle 1, Day 15, 0-5 and 5-24 hours post-dose|Participants in Groups 1-4 with available data||percentage of carfilzomib dose||Standard Deviation|Mean
771116|NCT00721734|Secondary|Percentage of Carfilzomib Excreted Via Renal Elimination on Day 1 of Cycle 1|The percentage of carfilzomib excreted in urine was calculated as the total amount excreted over 24 hours/dose.|Cycle 1, Day 1, 0-5 and 5-24 hours post-dose|Participants in Groups 1-4 with available data||percentage of carfilzomib dose||Standard Deviation|Mean
771117|NCT00721734|Secondary|Area Under the Concentration Time Curve to the Last Measurable Concentration (AUClast) for Carfilzomib on Day 15 of Cycle 2||Cycle 2, Day 15 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.|PK evaluable population with available data||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
771118|NCT00721734|Secondary|Area Under the Concentration Time Curve to the Last Measurable Concentration (AUClast) for Carfilzomib on Day 15 of Cycle 1||Cycle 1, Day 15 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.|PK evaluable population with available data||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
771119|NCT00721734|Secondary|Area Under the Concentration Time Curve to the Last Measurable Concentration (AUClast) for Carfilzomib on Day 1 of Cycle 1||Cycle 1, Day 1 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.|PK evaluable population||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
771120|NCT00721734|Secondary|Area Under the Plasma Curve Extrapolated to Infinity (AUCinf) for Carfilzomib on Day 15 of Cycle 2||Cycle 2, Day 15 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.|PK evaluable population with available data||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
771121|NCT00721734|Secondary|Area Under the Plasma Curve Extrapolated to Infinity (AUCinf) for Carfilzomib on Day 15 of Cycle 1||Cycle 1, Day 15 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.|PK evaluable population with available data||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
771122|NCT00721734|Secondary|Area Under the Plasma Curve Extrapolated to Infinity (AUCinf) for Carfilzomib on Day 1 of Cycle 1||Cycle 1, Day 1, before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.|PK evaluable population; AUCinf could not be estimated for 11 participants in the PK population who did not have adequate PK data.||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
771123|NCT00721734|Secondary|Maximum Observed Plasma Concentration of Carfilzomib on Day 15 of Cycle 2||Cycle 2, Day 15 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.|PK population with available data||ng/mL||Geometric Coefficient of Variation|Geometric Mean
771124|NCT00721734|Secondary|Maximum Observed Plasma Concentration of Carfilzomib on Day 15 of Cycle 1||Cycle 1, Day 15 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.|PK population with available data||ng/mL||Geometric Coefficient of Variation|Geometric Mean
771125|NCT00721734|Secondary|Maximum Observed Plasma Concentration of Carfilzomib on Day 1 of Cycle 1||Cycle 1, Day 1, before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.|PK population||ng/mL||Geometric Coefficient of Variation|Geometric Mean
771126|NCT00721734|Secondary|Clearance (CL) of Carfilzomib on Day 15 of Cycle 2||Cycle 2, Day 15, before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.|The pharmacokinetic (PK) evaluable population with available data||liters/hour||Standard Deviation|Mean
771127|NCT00721734|Secondary|Clearance (CL) of Carfilzomib on Day 15 of Cycle 1||Cycle 1, Day 15 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.|The pharmacokinetic (PK) evaluable population with available data||liters/hour||Standard Deviation|Mean
771128|NCT00721734|Primary|Clearance (CL) of Carfilzomib on Day 1 of Cycle 1|Plasma concentrations of carfilzomib was determined by a validated liquid chromatography tandem mass spectrometry (LC MS/MS) method. The lower limit of quantitation (LLOQ) was 0.300 ng/mL. Concentration values that were below the LLOQ (BLQ) were set to zero. Pharmacokinetic (PK) parameters were calculated from the individual plasma concentrations of carfilzomib using a noncompartmental method.|Cycle 1, Day 1 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.|"The pharmacokinetic (PK) evaluable population includes participants with stable baseline renal function (Arms 1–4) who completed all protocol-specified treatment and PK blood sample collection through Cycle 1, Day 16. In Group 5, only samples collected before dialysis were included.
CL could not be estimated for 11 patients in the PK population."||liters/hour||Standard Deviation|Mean
771129|NCT00721799|Primary|Efficacy of Percent Change in the Total Lesion Proliferation in Predicting Overall Survival (OS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed.|36 months|Participants who underwent both the pre-therapy and mid-therapy FLT PET scan||percentage change||Standard Deviation|Mean
771130|NCT00721799|Primary|Efficacy of Percent Change the Patlak Influx Rate Constant for FLT (K-Patlak) in Predicting Overall Survival (OS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed.|36 months|Participants who underwent both the pre-therapy and mid-therapy FLT PET scan||percentage change in K-Patlak||Standard Deviation|Mean
771174|NCT00722124|Primary|7-day Point Prevalence Smoking Abstinence at End of Treatment (Week 8)|7-day point prevalence smoking abstinence biochemically confirmed (expired carbon monoxide <8ppm)|8 weeks|Analysis was performed using intention to treat(ITT). Subjects who discontinued study participation were assumed to be smoking.||participants|||Number
771131|NCT00721799|Primary|Efficacy of Percent Change in FLT Flux (K-FLT) in Predicting Overall Survival (OS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed.|36 months|Participants who underwent both the pre-therapy and mid-therapy FLT PET scan||percentage change in K-FLT||Standard Deviation|Mean
771132|NCT00721799|Primary|Efficacy of Percent Change in Maximum FLT Uptake (SUVmax) in Predicting Overall Survival (OS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed.|36 months|Participants who underwent both the pre-therapy and mid-therapy FLT PET scan||percentage change in SUVmax||Standard Deviation|Mean
771133|NCT00721799|Primary|Efficacy of Percent Change in Mean FLT Uptake (SUVmean) in Predicting Overall Survival (OS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed.|36 months|Participants who underwent both the pre-therapy and mid-therapy FLT PET scan||percentage change in SUVmean||Standard Deviation|Mean
771134|NCT00721799|Primary|Efficacy of Mid-therapy Total Lesion Proliferation in Predicting Overall Survival (OS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed.|36 months|Participants who underwent the mid-therapy FLT PET scan||standardized uptake value (SUV)||Standard Deviation|Mean
771135|NCT00721799|Primary|Efficacy of the Patlak Influx Rate Constant for FLT (K-Patlak) Mid-therapy in Predicting Overall Survival (OS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed. The Patlak influx rate, measured in l /min, is the rate of transport of FLT from blood into the tissue as well as the rate of molecular change of FLT, using a Patlak analysis.|36 months|Participants who underwent the mid-therapy FLT PET scan||l/min||Standard Deviation|Mean
771136|NCT00721799|Primary|Efficacy of FLT Flux (K-FLT) Mid-therapy in Predicting Overall Survival (OS).|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat).Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed. FLT uptake in the tumor is a dynamic process that involves facilitated diffusion in and out of the cell and molecular changes in FLT. The rate K-FLT, measured in mL/g/min, is a composite of the rate of transport of FLT from blood into the tissue and the transfer from tissue back into the blood, as well as the rate of molecular change of FLT.|36 months|Participants who underwent the mid-therapy FLT PET scan||mL/g/min||Standard Deviation|Mean
771137|NCT00721799|Primary|Efficacy of Maximum Mid-therapy FLT Uptake (SUVmax) in Predicting Overall Survival (OS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed.|36 months|Participants who underwent the mid-therapy FLT PET scan||standardized uptake value (SUV)||Standard Deviation|Mean
771138|NCT00721799|Primary|Efficacy of Mean Mid-therapy FLT Uptake (SUVmean) in Predicting Overall Survival (OS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed.|36 months|Participants who underwent the mid-therapy FLT PET scan||standardized uptake value (SUV)||Standard Deviation|Mean
771139|NCT00721799|Primary|Efficacy of Pretherapy Total Lesion Proliferation in Predicting Overall Survival (OS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 27 subjects analyzed.|36 months|Participants who underwent the pre-therapy FLT PET scan||standardized uptake value (SUV)||Standard Deviation|Mean
771140|NCT00721799|Primary|Efficacy of the Patlak Influx Rate Constant for FLT (K-Patlak) Pre-therapy in Predicting Overall Survival (OS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 27 subjects analyzed. The Patlak influx rate, measured in l /min, is the rate of transport of FLT from blood into the tissue as well as the rate of molecular change of FLT, using a Patlak analysis.|36 months|Participants who underwent the pre-therapy FLT PET scan||l/min||Standard Deviation|Mean
771141|NCT00721799|Primary|Efficacy of FLT Flux (K-FLT) Pre-therapy in Predicting Overall Survival (OS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 27 subjects analyzed. FLT uptake in the tumor is a dynamic process that involves facilitated diffusion in and out of the cell and molecular changes in FLT. The rate K-FLT, measured in mL/g/min, is a composite of the rate of transport of FLT from blood into the tissue and the transfer from tissue back into the blood, as well as the rate of molecular change of FLT.|36 months|Participants who underwent the pre-therapy FLT PET scan||mL/g/min||Standard Deviation|Mean
771142|NCT00721799|Primary|Efficacy of Pre-therapy Metabolic Tumor Volume in Predicting Overall Survival (OS)|Metabolic tumor volume using the FLT PET tracer. Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 27 subjects analyzed.|36 months|Participants who underwent the pre-therapy FLT PET scan||mm^3 (cubic milimeters)||Standard Deviation|Mean
778142|NCT00774163|Secondary|Number of Subjects With at Least One PCR Positive Stool Specimen||Average of 36 day follow up period|||participants|||Number
771143|NCT00721799|Primary|Efficacy of Maximum Pre-therapy FLT Uptake (SUVmax) in Predicting Overall Survival (OS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Progression free survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 27 subjects analyzed.|36 months|Participants who underwent the pre-therapy FLT PET scan||standardized uptake value (SUV)||Standard Deviation|Mean
771144|NCT00721799|Primary|Efficacy of Mean Pre-therapy FLT Uptake (SUVmean) in Predicting Overall Survival (OS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 27 subjects analyzed.|36 months|Participants who underwent the pre-therapy FLT PET scan||standardized uptake value (SUV)||Standard Deviation|Mean
771145|NCT00721799|Primary|Efficacy of Percent Change in the Total Lesion Proliferation Between Scans 1 & 2 in Predicting Progression Free Survival (PFS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed.|36 months|Participants who underwent both the pre-therapy and mid-therapy FLT PET scan||percentage change||Standard Deviation|Mean
771146|NCT00721799|Primary|Efficacy of Percent Change the Patlak Influx Rate Constant for FLT (K-Patlak) Between Scans 1 & 2 in Predicting Progression Free Survival (PFS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed.|36 months|Participants who underwent both the pre-therapy and mid-therapy FLT PET scan||percentage change in K-Patlak||Standard Deviation|Mean
771147|NCT00721799|Primary|Efficacy of Percent Change in FLT Flux (K-FLT) Between Scans 1 & 2 in Predicting Progression Free Survival (PFS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed.|36 months|Participants who underwent both the pre-therapy and mid-therapy FLT PET scan||percentage change in K-FLT||Standard Deviation|Mean
771148|NCT00721799|Primary|Efficacy of Percent Change in Maximum FLT Uptake (SUVmax) Between Scans 1 & 2 in Predicting Progression Free Survival (PFS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed.|36 months|Participants who underwent both the pre-therapy and mid-therapy FLT PET scan||percentage change in SUVmax||Standard Deviation|Mean
771149|NCT00721799|Primary|Efficacy of Percent Change in Mean FLT Uptake (SUVmean) Between Scan 1 & 2 in Predicting Progression Free Survival (PFS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed.|36 months|Participants who underwent both the pre-therapy and mid-therapy FLT PET scan||percentage change in SUVmean||Standard Deviation|Mean
771150|NCT00721799|Primary|Efficacy of Mid-therapy Total Lesion Proliferation in Predicting Progression Free Survival (PFS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed.|36 months|Participants who underwent the mid-therapy FLT PET scan||standardized uptake value (SUV)||Standard Deviation|Mean
771151|NCT00721799|Primary|Efficacy of the Patlak Influx Rate Constant for FLT (K-Patlak) Mid-therapy in Predicting Progression Free Survival (PFS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed. The Patlak influx rate, measured in l /min, is the rate of transport of FLT from blood into the tissue as well as the rate of molecular change of FLT, using a Patlak analysis.|36 months|Participants who underwent the mid-therapy FLT PET scan||l/min||Standard Deviation|Mean
771152|NCT00721799|Primary|Efficacy of FLT Flux (K-FLT) Mid-therapy in Predicting Progression Free Survival (PFS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed. FLT uptake in the tumor is a dynamic process that involves facilitated diffusion in and out of the cell and molecular changes in FLT. The rate, measured in mL/g/min, is a composite of the rate of transport of FLT from blood into the tissue and the transfer from tissue back into the blood, as well as the rate of molecular change of FLT.|36 months|Participants who underwent the mid-therapy FLT PET scan||mL/g/min||Standard Deviation|Mean
771153|NCT00721799|Primary|Efficacy of Maximum Mid-therapy FLT Uptake (SUVmax) in Predicting Progression Free Survival (PFS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed.|36 months|Participants who underwent the mid-therapy FLT PET scan||standardized uptake value (SUV)||Standard Deviation|Mean
771154|NCT00721799|Primary|Efficacy of Mean Mid-therapy FLT Uptake (SUVmean) in Predicting Progression Free Survival (PFS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed.|36 months|Participants who underwent the mid-therapy FLT PET scan||standardized uptake value (SUV)||Standard Deviation|Mean
771572|NCT00727857|Secondary|Change From Baseline in Intermediate-Density Low Density Lipoprotein Concentration|The change between Intermediate-Density Low Density Lipoprotein collected at final visit or week 24 and Intermediate-Density Low Density Lipoprotein collected at baseline|Baseline and Week 24|||nmol/L||Standard Error|Least Squares Mean
771155|NCT00721799|Primary|Efficacy of Pretherapy Total Lesion Proliferation in Predicting Progression Free Survival (PFS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 27 subjects analyzed.|36 months|Participants who underwent the pre-therapy FLT PET scan||standardized uptake value (SUV)||Standard Deviation|Mean
771156|NCT00721799|Primary|Efficacy of the Patlak Influx Rate Constant for FLT (K-Patlak) Pre-therapy in Predicting Progression Free Survival (PFS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 27 subjects analyzed. The Patlak influx rate, measured in l /min, is the rate of transport of FLT from blood into the tissue as well as the rate of molecular change of FLT, using a Patlak analysis.|36 months|Participants who underwent the pre-therapy FLT PET scan||l/min||Standard Deviation|Mean
771157|NCT00721799|Primary|Efficacy of FLT Flux (K-FLT) Pre-therapy in Predicting Progression Free Survival (PFS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 27 subjects analyzed. FLT uptake in the tumor is a dynamic process that involves facilitated diffusion in and out of the cell and molecular changes in FLT. The rate, measured in mL/g/min, is a composite of the rate of transport of FLT from blood into the tissue and the transfer from tissue back into the blood, as well as the rate of molecular change of FLT.|36 months|Participants who underwent the pre-therapy FLT PET scan||mL/g/min||Standard Deviation|Mean
771158|NCT00721799|Primary|Efficacy of Pre-therapy Metabolic Tumor Volume in Predicting Progression Free Survival (PFS)|Metabolic tumor volume using the FLT PET tracer. Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 27 subjects analyzed.|36 months|Participants who underwent the pre-therapy FLT PET scan||mm^3 (cubic milimeters)||Standard Deviation|Mean
771159|NCT00721799|Primary|Efficacy of Maximum Pre-therapy FLT Uptake (SUVmax) in Predicting Progression Free Survival (PFS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 27 subjects analyzed.|36 months|Participants who underwent the pre-therapy FLT PET scan||standardized uptake value (SUV)||Standard Deviation|Mean
771160|NCT00721799|Primary|Efficacy of Mean Pre-therapy FLT Uptake (SUVmean) in Predicting Progression Free Survival (PFS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 27 subjects analyzed.|36 months|Participants who underwent the pre-therapy FLT PET scan||standardized uptake value (SUV)||Standard Deviation|Mean
771161|NCT00721955|Secondary|CGI-I Responders|Frequency of response based on the CGI-I (defined as achieving a CGI-I score of 1 or 2 at 2 hours after administration of the inhalation)|Baseline and 2 hours|ITT Population with LOCF||Participants|||Count of Participants
771162|NCT00721955|Secondary|Clinical Global Impression-Improvement (CGI-I) Score Following Dose #1 of Staccato Loxapine, Compared With Placebo|Clinical Global Impression- Improvement (CGI-I) scores ranged from 1 to 7: 0=not assessed (missing), 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse.|Baseline and 2 hours|ITT Population with LOCF||units on a scale||Standard Deviation|Mean
771163|NCT00721955|Primary|Change in PANSS Excited Component (PEC) Score From Baseline Following Dose #1 of Staccato Loxapine, Compared With Placebo|The Positive and Negative Syndrome Scale–Excited Component (PANSS–EC) comprises 5 items associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored 1 (min) to 7 (max). The PANSS-EC, the sum of these 5 subscales, thus ranges from 5 to 35. Individuals were eligible if they had a PANSS-EC of ≥14 (out of 35) and a score ≥4 (out of 7) on at least 1 of the 5 items.|Baseline and 2 hours|ITT Population with LOCF||units on a scale||Standard Deviation|Mean
771164|NCT00721968|Other Pre-specified|Number of Ocular Hypotensive Medications by Visit||12 months|||medications||Standard Deviation|Mean
771165|NCT00721968|Primary|Month 12 Intraocular Pressure ≤ 18 mmHg Without Topical Hypotensive Medications|Percent reaching this endpoint|12 months|Number of subjects at Month 12 with IOP ≤ 18 mmHg without topical hypotensive medications||participants|||Number
771166|NCT00722020|Secondary|Secondary Endpoint Total Hospital Length of Stay|Seconadary endpoint was Total Hospital length of stay|30 Days|||days||Standard Deviation|Mean
771167|NCT00722020|Primary|The Primary Endpoint Will be Time to Readiness for Discharge.|Days in the hospital prior to patient being clinically ready to discharge|30 days|asthmatic children||days||Standard Deviation|Mean
771168|NCT00722072|Secondary|Safety and Tolerability Profile||Continuous throughout study and 28 to 56 days after discontinuation of study therapy||||||
771169|NCT00722072|Secondary|Overall Survival||28 to 56 days after discontinuation of study therapy||||||
771170|NCT00722072|Secondary|Progression-free Survival||Start of treatment to time of progression or death, whichever comes first.||||||
771171|NCT00722072|Secondary|Time to Progression||Start of treatment to time of progression.||||||
771172|NCT00722072|Secondary|Objective Response Rate||Every 8 weeks (two cycles) while receiving study therapy.||||||
771173|NCT00722072|Primary|Number of Participants With Progression-free Survival at 4 Months|Progression-free survival rate is defined as the proportion of subjects who are progression free (CR, PR and SD) at 4 months after initiating treatment with sorafenib plus fulvestrant. Complete Response (CR):Disappearance of all target (both measurable and evaluable)lesions. Partial Response (PR):At least a 30% decrease in the sum of the longest diameter (LD) of both measurable and evaluable target lesions. Stable Disease (SD):Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease(PD).|4 months after initiating treatment with sorafenib plus fulvestrant.|||Participants|||Number
771175|NCT00722137|Secondary|Number of Participants Experiencing an Adverse Event (AE)|An AE was defined as any untoward medical occurrence associated with the use of a drug, whether or not considered drug related. AEs were collected from the first dose of study drug through 30 days after the last dose of study drug. Treatment was administered for up to 8 cycles (24 weeks) and AEs were collected for up to 30 days following the last dose of study drug.|Up to Week 28|The safety population was defined as all randomized participants who received at least 1 dose of study medication.||Participants|||Number
771176|NCT00722137|Secondary|18-Month Survival|18-month survival was defined as the estimated probability of survival at 18 months (Kaplan-Meier estimate).|Up to month 18 from the time of randomization|The population consisted of all radmonized participants.||Percentage of Participants||95% Confidence Interval|Mean
771177|NCT00722137|Secondary|Overall Survival (OS)|OS was measured from the date of randomization to the date of the participant's death. If the participant was alive or the vital status was unknown, OS was censored at the date that the subject was last known to be alive.|Median duration of follow-up of 40 months|The population consisted of all randomized participants.||Days||95% Confidence Interval|Median
771178|NCT00722137|Secondary|Overall Complete Response (CR + CRu)|Overall complete response was defined as the number of participants with complete response (CR) and those with unconfirmed complete response (CRu). ). Response assessment was carried out every 6 weeks for 18 weeks; thereafter, every 8 weeks until PD/initiation of alternate therapy/withdrawal from study/death.|Median duration of follow-up of 40 months|The response-evaluable population was defined as all participants who received >= 1 dose of study drug, had at least 1 measurable tumor mass (>1.5 cm in the longest dimension and >1.0 cm in the short axis) at baseline and had at least 1 post-baseline tumor assessment by Independent Review Committee, before any subsequent anti-lymphoma treatment.||Participants|||Number
771179|NCT00722137|Secondary|Overall Response Rate (ORR)|ORR was defined as complete response (CR) + complete response, unconfirmed (CRu) + partial response (PR) as determined by the Independent Review Committee. Response assessment was carried out every 6 weeks for 18 weeks; thereafter, every 8 weeks until PD/initiation of alternate therapy/withdrawal from study/death.|Median duration of follow-up of 40 months|The response-evaluable population was defined as all participants who received >= 1 dose of study drug, had at least 1 measurable tumor mass (>1.5 cm in the longest dimension and >1.0 cm in the short axis) at baseline and had at least 1 post-baseline tumor assessment by Independent Review Committee, before any subsequent anti-lymphoma treatment.||Participants|||Number
771180|NCT00722137|Secondary|Treatment-free Interval (TFI)|The TFI was defined as the duration from the date of last dose plus 1 day to the start date of the new treatment. Death due to disease progression prior to subsequent therapy was considered as an event. Otherwise, treatment-free interval was censored at the date of death or the last date known to be alive.|Median duration of follow-up of 40 months|All randomized participants who received at least 1 dose of study medication.||Days||95% Confidence Interval|Median
771181|NCT00722137|Secondary|Time to Next Anti-lymphoma Treatment (TTNT)|The time to next anti-lymphomatreatment was measured from the date of initiation of study treatment as per protocol to the start date of new anti-lymphoma treatment. Death due to disease progression prior to subsequent therapy was considered as an event. Otherwise, time to next anti lymphoma treatment was censored at the date of death or the last date known to be alive.|: Median duration of follow-up of 40 months|The population consisted of all randomized participants.||Days||95% Confidence Interval|Median
771182|NCT00722137|Secondary|Duration of Response|The duration of treatment response was defined as the time from the date of the first response to the date of PD or death due to PD for those participants with a best response of CR, CRu, or PR as determined by the Independent Review Committee. The duration of response for complete responders was defined as the time from the date of the first response to the date of PD or death due to PD for those participants with a best response of CR or CRu verified by bone marrow and lactate dehydrogenase (LDH).|Median duration of follow-up of 40 months|The response-evaluable population was defined as all participants who received at least 1 dose of study drug, had >= 1 measurable tumor mass (>1.5 cm in the longest dimension and >1.0 cm in the short axis) at baseline and had at least 1 post-baseline tumor assessment by Independent Review Committee, before any subsequent anti-lymphoma treatment.||Days||95% Confidence Interval|Median
771183|NCT00722137|Secondary|Time to Progression (TTP)|Time to progression was defined as the duration from the date of randomization until the date of first documented evidence of progressive disease (PD) or date of relapse for subjects who experienced complete response (CR) or complete response, unconfirmed (CRu). PD and response were based on the assessment of an Independent Review Committee.|Median duration of follow-up of 40 months|The population consisted of all randomized participants.||Days||95% Confidence Interval|Median
771184|NCT00722137|Primary|Progression Free Survival (PFS)|PFS was defined as the interval between the date of randomization and the date of progressive disease (PD) or death, whichever occurred first. PD was based on the assessment of an Independent Review Committee.|Median duration of follow-up of 40 months|The population consisted of all randomized participants.||Days||95% Confidence Interval|Median
771185|NCT00722371|Secondary|Change From Baseline in 2-Hour PMG at Week 54|PMG was measured using the Meal Tolerance Test (MTT).|Baseline and Week 54|Full Analysis Set with LOCF. Reasons for exclusion included no baseline data and/or no post-baseline data.||mg/dL||95% Confidence Interval|Least Squares Mean
771186|NCT00722371|Secondary|Change From Baseline in FPG at Week 54||Baseline and Week 54|Full Analysis Set with LOCF. Reasons for exclusion included no baseline data and/or no post-baseline data.||mg/dL||95% Confidence Interval|Least Squares Mean
771187|NCT00722371|Primary|Change From Baseline in A1C at Week 54|A1C represents the percentage of glycosylated hemoglobin.|Baseline and Week 54|Full Analysis Set with LOCF. Reasons for exclusion included no baseline data and/or no post-baseline data.||Percent of glycosylated hemoglobin||95% Confidence Interval|Least Squares Mean
771188|NCT00722371|Secondary|Change From Baseline in 2-Hour Post-meal Glucose (PMG) at Week 24|PMG was measured using the Meal Tolerance Test (MTT).|Baseline and Week 24|Full Analysis Set with LOCF. Reasons for exclusion included no baseline data and/or no post-baseline data.||mg/dL||95% Confidence Interval|Least Squares Mean
771189|NCT00722371|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24||Baseline and Week 24|Full Analysis Set with LOCF. Reasons for exclusion included no baseline data and/or no post-baseline data.||mg/dL||95% Confidence Interval|Least Squares Mean
771190|NCT00722371|Primary|Change From Baseline in Hemoglobin A1C (A1C) at Week 24|A1C represents the percentage of glycosylated hemoglobin.|Baseline and Week 24|Full Analysis Set with last observation carried forward (LOCF). Reasons for exclusion included no baseline data and/or no post-baseline data.||Percentage of glycosylated hemoglobin||95% Confidence Interval|Least Squares Mean
771191|NCT00722423|Secondary|Antiviral Treatment Rate|Number of patients started antiviral treatment|12-24 weeks post-treatment|||percentage of participants|||Number
771192|NCT00722423|Primary|Sustained Virologic Response Rates|Virus not detected by PCR assay|12-24 weeks post-treatment|||participants|||Number
771193|NCT00722436|Secondary|Platelets||baseline, after osteotomies, immediately after surgery|||10^9 platelets/L||Standard Deviation|Mean
771194|NCT00722436|Secondary|Effect of Tranexamic Acid on Prothrombin Time (PT), Partial Thromboplastin Time (PTT) at Three Time Points (Baseline, After Osteotomies, and Immediately After Procedure).||(baseline, after osteotomies, and immediately after procedure)|||seconds||Standard Deviation|Mean
771195|NCT00722436|Primary|Number of Patients That Remained Transfusion Free||24 hours|||participants|||Number
771196|NCT00722436|Primary|Total Volume (ml/kg) of Allogeneic Blood Exposure.|This is the blood administered during surgery. The blood comes form the blood bank. It is not cell salvage blood. The volume was normalized by weight.|intraoperative and postoperative (24 hr)|||ml/kg||Standard Deviation|Mean
771197|NCT00722553|Secondary|Overall Survival (OS)|The number of days from study day 1 to death. Patients who had not died (no record of death) or were lost to follow-up were censored at the date of last contact.|Assessed at the end of each even-numbered cycle (every 8 weeks), or per standard of care if treatment has ended (at least every 12 weeks) for up to 2 years after enrollment. After PD or start of subsequent treatment, OS will be assessed every 4 months.|Analysis per protocol. Patients who had not died or were lost to follow-up were censored||Months||95% Confidence Interval|Median
771198|NCT00722553|Secondary|Progression Free Survival (PFS)|Length of time from study day 1 to the date of radiological evidence of PD (date of computed tomography [CT] or magnetic resonance imaging [MRI] scan, whichever indicates PD) or death, regardless of cause.|Assessed at the end of each even-numbered cycle (every 8 weeks), or per standard of care but no more than every 12 weeks (+/- 1 week) if treatment has ended, for up to 2 years after enrollment.|Analysis was per protocol, based on the number of patients (pts) who had an event of progressive disease (PD) or death. Pts who did not have an event at the time of data cut-off were censored.||Months||95% Confidence Interval|Median
771199|NCT00722553|Secondary|Clinical Benefit Rate (CBR)|The number of patients with a best confirmed or unconfirmed response of CR, PR, or stable disease (SD) for at least 24 weeks (approximately 5.5 months)|Assessed at the end of each even-numbered cycle (every 8 weeks) or per standard of care, but no more than every 12 weeks (+/- 1 week) if treatment has ended, for up to 2 years after enrollment.|||participants|||Number
771200|NCT00722553|Secondary|Duration of Response (DOR)|Duration of time from when tumor measurement criteria were met for CR or PR (whichever status was recorded first) until the first date that recurrent disease or progressive disease (PD) or death was objectively documented. Progression is defined, using RECIST, as an increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline. Calculated for those patients with a best overall confirmed or unconfirmed response of CR or PR.|Measured from the first day of documented response for up to 2 years after enrollment.|Analysis was per protocol, based on the number of all responding patients both confirmed and unconfirmed (n=5) in the evaluable population (n=30)||Days||95% Confidence Interval|Median
771201|NCT00722553|Primary|Objective Response Rate (ORR)|The number of patients with a best overall confirmed response of either complete response (CR) or partial response (PR)|Assessed at the end of each even-numbered cycle (every 8 weeks), or per standard of care but no more than every 12 weeks (+/- 1 week) if treatment has ended for up to 2 years after enrollment.|||participants|||Number
771202|NCT00722566|Secondary|Number of Patients With Complete Response|"Disease response was measured according to European Group for Blood and Marrow Transplantation (EBMT) criteria with the addition of the response categories of nCR and VGPR.
Complete response requires disappearance of monoclonal protein from the blood and urine and <5% plasma cells in the bone marrow on at least 2 determinations for a minimum of 6 weeks."|Over 4 cycles (prior to the addition of dexamethasone)|The response-evaluable population was defined as subjects who received at least 1 dose of study drug and had measurable, secretory multiple myeloma, defined as a serum monoclonal IgG or IgM of ≥10 g/L or a serum monoclonal IgA or IgE ≥5 g/L, or a serum monoclonal IgD of ≥0.5g/L, or urine M-protein of ≥200 mg/24 hours, at study entry.||Participants|||Number
771203|NCT00722566|Primary|Number of Patients With Overall Response (Complete Response + Partial Response)|"Disease response was measured according to European Group for Blood and Marrow Transplantation (EBMT) criteria with the addition of the response categories of nCR and VGPR.
Complete response requires disappearance of monoclonal protein from the blood and urine and <5% plasma cells in the bone marrow on at least 2 determinations for a minimum of 6 weeks.
Partial Response requires ≥50% reduction in serum m-protein for at least 2 determinations at least 6 weeks apart and if present, reduction in 24-hour urinary light chain excretion by either ≥90% or to <200 mg"|Over 4 cycles (prior to the addition of dexamethasone)|The response-evaluable population was defined as subjects who received at least 1 dose of study drug and had measurable, secretory multiple myeloma, defined as a serum monoclonal IgG or IgM of ≥10 g/L or a serum monoclonal IgA or IgE ≥5 g/L, or a serum monoclonal IgD of ≥0.5g/L, or urine M-protein of ≥200 mg/24 hours, at study entry.||Participants|||Number
771204|NCT00722722|Primary|Response to Bortezomib Monotherapy|Response to treatment with Bortezomib (BTZ) alone was defined as a reduction in serum Donor Specific Alloantibody (DSA) levels following treatment. DSA levels were measured prior to treatment and after treatment. A good response occurred if all DSA were reduced. A partial response when a reduction was observed in at least one DSA, but not all DSA. No response occurred when no reduction of any DSA was attained.|6 months|In the 32 dose group, one patient received a kidney transplant with a B-cell flow cytometric crossmatch channel shift of less than 300 after dose 20 and was transplanted with a positive crossmatch donor. This patient was then excluded from further DSA analysis.||participants|||Number
771360|NCT00723554|Primary|Change in Systolic Blood Pressure - (Period 1 to Period 3)|Systolic blood pressure was measured on Day 1 prior to treatment with Iloprost PD-15 (Period 1) and at the end of treatment with Iloprost PD-15 (Period 3)|Day 1 and End of study visit, an average of approximately 268 days|Safety population - missing data were not imputed||mmHg||Standard Deviation|Mean
771205|NCT00722761|Secondary|Percentage of Subjects Rated Clear or Almost Clear on the IGA and SGA at Week 24/ Early Termination|Percentage of subjects rated Clear (score 0) or Almost Clear (score 1) on the Investigator's Global Assessment (IGA) of truncal acne at Week 24 as well as Subject's Assessment of Acne at Week 24/Early Termination were taken. It was computed by: number of successes (those scored 0 or 1)divided by the number of participants multiplied by 100.|24 weeks|Intention to treat analysis. Participants with at least one follow up visit were included in the analysis. Last observation carried forward was used to fill up missing values/||percentage of participants|||Number
771206|NCT00722761|Primary|Percent Change in Truncal Lesion Counts|Acne lesion count (noninflammatory, inflammatory and total lesions) difference between week 0 (baseline) and week 24 is divided by the acne lesion count at week 0 and multiplied by 100. A positive change indicates a decrease in truncal acne lesions.|0-24 weeks|Intention to treat analysis. Only participants with at least one follow up were included in the analysis. Last observation carried forward was used to fill up missing data.||percentage change of lesions||Standard Deviation|Mean
771207|NCT00722800|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Month 6.|Dermatology Life Quality Index (DLQI) Score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. The DLQI score ranges from 0 (best) to 30 (worst).|6 months|||points||Standard Deviation|Mean
771208|NCT00722800|Secondary|Change From Baseline in VAS Pain Scale at Month 6.|"For this pain assessment, the participant indicated the level of average pain experienced over the past 24 hours on a horizontal line, 10 cm in length. A score of 0 indicated no pain and a score of 10 indicated worst pain. The value indicates the change from the baseline participant assessment on the 0 to 10 scale. A negative value indicates a reduction in pain intensity."|6 months from Baseline|||units on a scale||Standard Deviation|Mean
771209|NCT00722800|Primary|Mean Improvement in the Sartorius Severity Score at Month 6.|The Sartorius Severity score reflects changes in hidradenitis suppurative symptoms, namely the number of lesions (abscesses, nodules, and fistulas) and the longest distance between lesions. A total score is derived based on assessments at up to 8 distinct anatomical regions and ranges from 5 to indefinite. Smaller numbers are better scores and indicate less lesion involvement, thus decreases (negative changes) from baseline indicate improvement in severity of disease.|6 months|||units on a scale||Standard Deviation|Mean
771215|NCT00723008|Primary|Mean General Sleep Disturbance Scale (GSDS) Score|The GSDS is a questionnaire used to qualitatively evaluate sleep. This 21-question tool evaluates each aspect of sleep and restfulness on a 0-7 score, indicating the number of days per week that each problem may be present. Total scores range from 0-147, with higher scores indicating more profound disturbances in sleep.|Baseline, Week 4, Week 8|All subjects who remained in study at each given period were analyzed. Therefore, the number of subjects examined decreased at each interval.||Score||Standard Deviation|Mean
771216|NCT00723008|Primary|Mean Visual Analogue Scale of Anxiety (VAS-A) Before and After Cranial Electrotherapy Stimulation (CES).|Subjects were asked to evaluate their anxiety level before and after each daily CES treatment. Responses were scored on a scale ranging from 0 (indicating no anxiety) to 10 (worst possible).|Blinded Period, Unblinded Period|All subjects who remained in study at each given period were analyzed. Therefore, the number of subjects examined decreased at each interval||VAS-A Score||Standard Deviation|Mean
771217|NCT00723008|Primary|Mean Visual Analogue Scale of Pain (VAS-P) Before and After Cranial Electrotherapy Stimulation (CES).|Subjects were asked to evaluate their pain intensity before and after each daily CES or sham treatment. Responses were scored on a scale ranging from 0 (indicating no pain) to 10 (worst possible pain).|Blinded Period, Unblinded Period|All subjects who remained in study at each given period were analyzed. Therefore, the number of subjects examined decreased at each interval.||VAS-P Score||Standard Deviation|Mean
771218|NCT00723008|Primary|Mean Brief Profile of Mood States (BPOMS) Score|BPOMS is a tool used to qualitatively measure anxiety. Subjects were asked to evaluate 30 feelings that they may have had over the past week. Stress-associated feelings are scored on a 5-point Likert scale from 0 (not at all)to 4 (extremely). Six of the feelings listed on the questionnaire are not associated with anxiety and therefore are not scored. Total scores range from 0-96, with higher scores indicating greater tension and anxiety.|Baseline, Week 4, Week 8|One A:Active/Unblinded subject was removed from analysis due to a 39-point outlying score. All other subjects who remained in study at each given period were analyzed. Therefore, the number of subjects examined decreased at each interval.||Brief POMS Score||Standard Deviation|Mean
771219|NCT00723008|Primary|Mean Center for Epidemiological Studies-Depression Scale (CES-D) Score|This 20-item questionnaire measures depressive symptoms. Scores can range from 0-60, with scores greater than 16 indicating need for further evaluation due to possible Major Depression.|Baseline, 4 Weeks, 8 Weeks|One A:Active/Unblinded subject was removed from analysis due to a 31-point outlying score. All other subjects who remained in study at each given period were analyzed. Therefore, the number of subjects examined decreased at each interval.||Score||Standard Deviation|Mean
771220|NCT00723008|Primary|Mean Post-Traumatic Stress Questionnaire-Military (PCL-M) Score|Subjects were asked to complete questionnaire three times during the course of study. Questions addressed symptoms associated with Post Traumatic Stress Disorder(PTSD). Scores can range from 17 to 85. A score >31 was used to identify symptomatic subjects and was therefore required at baseline for study enrollment.|Baseline, Week 4, Week 8|All active subjects||Score||Standard Deviation|Mean
771221|NCT00723021|Other Pre-specified|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]|AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).|14 and 24 hours following dosing in each period.|Since the PK sample collection only occurred until 24 hours and the approximate t1/2 at all doses appeared to be >10 hours, t1/2 and area under the plasma concentration versus time curve until infinity (AUCinf) are not reported at any dose level.|||||
771222|NCT00723021|Other Pre-specified|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Pre-dose, 2, 4, 5, 6, 10, 14 and 24 hours following dosing in each period.|Since the PK sample collection only occurred until 24 hours and the approximate t1/2 at all doses appeared to be >10 hours, t1/2 and area under the plasma concentration versus time curve until infinity (AUCinf) are not reported at any dose level.|||||
771223|NCT00723021|Other Pre-specified|Time to Reach Maximum Observed Plasma Concentration (Tmax)||Pre-dose, 2, 4, 5, 6, 10, 14 and 24 hours following dosing in each period.|||hrs||Full Range|Median
771224|NCT00723021|Other Pre-specified|Maximum Observed Plasma Concentration (Cmax)||Pre-dose, 2, 4, 5, 6, 10, 14 and 24 hours following dosing in each period.|All enrolled subjects treated who have at least one of the PK parameters of interest in at least one treatment period.||ng/mL||Standard Deviation|Mean
771225|NCT00723021|Other Pre-specified|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|Pre-dose, 2, 4, 5, 6, 10, 14 and 24 hours following dosing in each period.|All enrolled subjects treated who have at least one of the PK parameters of interest in at least one treatment period.||ng*h/mL||Standard Deviation|Mean
771226|NCT00723021|Secondary|Change From Baseline in Forced Expiratory Flow Between 25 and 75% of Vital Capacity (FEF25-75)|The FEF25-75 is the forced expiratory flow between 25 and 75% of vital capacity|Baseline, 24 hours (hrs) post-dose|All enrolled participants treated who had at least 1 concentration in at least 1 treatment period||L||Standard Deviation|Mean
771227|NCT00723021|Secondary|Change From Baseline in Forced Expiratory Flow Between 25 and 75% of Vital Capacity (FEF25-75)|The FEF25-75 is the forced expiratory flow between 25 and 75% of vital capacity|Baseline, 12 hours (hrs) post-dose|All enrolled participants treated who had at least 1 concentration in at least 1 treatment period||L/Sec||Standard Deviation|Mean
771228|NCT00723021|Secondary|Change From Baseline in Forced Vital Capacity (FVC)|The FVC is the maximal volume of air that can be exhaled from full inhalation by exhaling as forcefully and rapidly as possible|Baseline,24 hours (hrs) post-dose|All enrolled participants treated who had at least 1 concentration in at least 1 treatment period||L||Standard Deviation|Mean
771229|NCT00723021|Secondary|Change From Baseline in Forced Vital Capacity (FVC)|The FVC is the maximal volume of air that can be exhaled from full inhalation by exhaling as forcefully and rapidly as possible|Baseline, 12 hours (hrs) post-dose|All enrolled participants treated who had at least 1 concentration in at least 1 treatment period||L||Standard Deviation|Mean
771230|NCT00723021|Primary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)|The FEV1 is the maximal volume of air that can be forcefully exhaled in one second|Baseline, 24 hours (hrs) post-dose|All enrolled participants treated who had at least 1 concentration in at least 1 treatment period||L||Standard Deviation|Mean
771231|NCT00723021|Primary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)|The FEV1 is the maximal volume of air that can be forcefully exhaled in one second|Baseline, 12 hours (hrs) post-dose|All enrolled participants treated who had at least 1 concentration in at least 1 treatment period||L||Standard Deviation|Mean
771232|NCT00723073|Secondary|Duration of Neutropenia|Median number of days patients were neutropenic during the study period|11/1/2005 - 10/31/2007|||days||Inter-Quartile Range|Median
771233|NCT00723073|Secondary|Duration of Hospitization|Median number of days patients were hospitalized during the study period|11/1/2005 - 10/31/2007|||days||Inter-Quartile Range|Median
771234|NCT00723073|Secondary|Specific Type of Adverse Event That Resulted in Echinocandin (EC) Therapy Discontinuation|The description of the adverse event that resulted in discontinuation of echinocandin (EC) therapy|11/1/2005 - 10/31/2007|||participants|||Number
771235|NCT00723073|Secondary|Liver Function Tests (LFTs) Elevated During or After Echinocandin Therapy|aspartate aminotransferase (AST) or alanine aminotransferase (ALT)> 5x the upper limit of normal (ULN) or total bilirubin > 3x the upper limit of normal (ULN)|11/1/2005 - 10/31/2007|||participants|||Number
771236|NCT00723073|Secondary|Duration of Echinocadin Therapy for Persistent Febrile Neutropenia (FN)|median duration of therapy with an echinocandin (caspofungin or micafungin) for persistent febrile neutropenia (FN)|11/1/2005 - 10/31/2007|||days||Inter-Quartile Range|Median
771237|NCT00723073|Primary|Lack of an Adverse Drug Event (ADE) Attributable to Echinocandin (EC) Therapy That Led to Discontinuation of Therapy|Defined as any advsere event directly attributable to echinocandin treatment that led to discontinuation of therapy or switch to alternative therapy|11/1/2005 - 10/31/2007|||participants|||Number
771238|NCT00723073|Primary|Absence of Any Breakthrough Invasive Fungal Disease (IFD)|a breakthrough invasive fungal disesase was defined as any fungal infection that was diagnosed > 3 days on or during therapy or within 7 days after completion of therapy with an echinocandin|11/1/2005 - 10/31/2007|||participants|||Number
771239|NCT00723073|Primary|Mortality at Hospital Discharge|We assessed all patients in the study cohort who dischaged from the hospital alive|11/1/2005 - 10/31/2007|||participants|||Number
771240|NCT00723073|Primary|Successful Treatment of Any Baseline Invasive Fungal Disease (IFD)|Possible or proven baseline invasive fungal disease were defined as were diagnosed within the 2 days of initiating echinocandin therapy for persistent febrile neutropenia|11/1/2005 - 10/31/2007|||participants|||Number
771361|NCT00723554|Primary|Change in Systolic Blood Pressure - (Period 1 to Period 2)|Systolic blood pressure was measured on Day 1 prior to treatment with Iloprost PD-15 (Period 1) and Day 28 of treatment with Iloprost PD-15 (Period 2)|Day 1 and Day 28|Safety population - missing data were not imputed||mmHg||Standard Deviation|Mean
771241|NCT00723073|Primary|Composite Primary Endpoint: Number of Participants With an Overall Favorable Response to Echinocandin Therapy for Empiric Antifungal Therapy for Persistent Febrile Neutropenia (FN)|Overall favorable response was defined as achievement of successful treatment of baseline fungal infections, survival to hospital discharge, absence of breakthrough Ivasive fungal disese (IFD), and lack of advserse events (AE) attributable to treatment that led to discontinuation of echinocandin therapy.|11/1/2005 - 10/31/2007|||participants|||Number
771242|NCT00723125|Secondary|Measure of Safety and Tolerability According to CTC Version 3.0||2 years||||||
771243|NCT00723125|Primary|Pathological Complete Response Rates at Surgery||at surgery approximately 5 months after initial treatment|Cohort1: 33 pts enrolled to cohort 1,33 underwent surgery even if they did not complete all treatment Cohort 2: 27 enrolled to cohort 2 and 27 underwent surgery, even if they did not complete all treatment||participants|||Number
771244|NCT00723177|Secondary|The Effects of AV411 on the Analgesic Effects of Oxycodone.|The McGill Pain Questionnaire (Melzack, 1987) was used to assess pain experience immediately following the immersion of the hand in 4 degree Celsius water. Scores were added across all 15 items to generate a sum score, which ranged between 15 and 60. Larger scores indicate greater pain levels.|Measured at the end of each AV411 of the three two-week maintenance periods|||units on a scale||Standard Deviation|Mean
771245|NCT00723177|Primary|Subjective Opioid Withdrawal Scale Score (SOWS)|Measures severity of opioid withdrawal in opioid dependent populations (0-64). Larger values indicate more severe withdrawal.|Measured at the end of each two-week maintenance period (i.e., Placebo, Low AV411, High AV411).|Only 30 of the total number of 44 enrolled completed the study .||units on a scale||Standard Error|Mean
771246|NCT00723190|Secondary|Change From Baseline in Clinical Global Impressions-Improvement (CGI-I) at Months 1, 2, 3, 4, 6, 9, and 12|"CGI-I scale:
1 = Very much improved; 2 = Much improved; 3 = Minimally improved; 4 = No change; 5 = Minimally worse; 6 = Much worse; 7 = Very much worse"|At baseline, months 1, 2, 3, 4, 6, 9, and 12|Efficacy summaries and analyses are based on the efficacy evaluable population which included subjects who took one or more doses of study medication and had at least one post-baseline efficacy measurement||Units on a scale||Standard Deviation|Mean
771247|NCT00723190|Secondary|Change From Baseline in Clinical Global Impressions-Severity (CGI-S) at Months 1, 2, 3, 4, 6, 9, and 12|"CGI-S scale:
1 = Normal, not ill at all; 2 = Borderline ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill patients"|At baseline, months 1, 2, 3, 4, 6, 9, and 12|Efficacy summaries and analyses are based on the efficacy evaluable population which included subjects who took one or more doses of study medication and had at least one post-baseline efficacy measurement||Units on a scale||Standard Deviation|Mean
771248|NCT00723190|Primary|Change From Baseline in 12-lead Electrocardiogram in Terms of Heart Rate at Week 4||At baseline and at Week 4|Data analysis involved the safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population||beats per minute||Standard Deviation|Mean
771249|NCT00723190|Primary|Change From Baseline in Heart Rate at Week 4|Heart rate was measured with the subject in a sitting position and resting for at least 2 minutes prior to taking the measurement|At baseline and at Week 4|Data was analyzed based on safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population||beats per minute||Standard Deviation|Mean
771250|NCT00723190|Primary|Change From Baseline in Body Temperature at Week 4|Temperature was measured with the subject in a sitting position and resting for at least 2 minutes prior to taking the measurement|At baseline and at Week 4|Data analysis was performed on safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population||Fahrenheit||Standard Deviation|Mean
771251|NCT00723190|Primary|Change From Baseline in Systolic Blood Pressure at Week 4|Blood pressure was measured with the subject in a sitting position and resting for at least 2 minutes prior to taking the measurement. The dominant arm was used for the measurement|At baseline and at Week 4|Data was analyzed based on safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population||mmHg||Standard Deviation|Mean
771252|NCT00723190|Primary|Change From Baseline in Diastolic Blood Pressure at Week 4|Blood pressure was measured with the subject in a sitting position and resting for at least 2 minutes prior to taking the measurement. The dominant arm was used for the measurement|At baseline and at Week 4|Data was anlyzed based on safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population||mmHg||Standard Deviation|Mean
771253|NCT00723190|Primary|Change From Baseline in Body Weight at Weeks 1, 2, 3, 4, and Months 2, 3, 4, 5, 6, 9, and 12||At baseline and at weeks 1, 2, 3, 4, and months 2, 3, 4, 5, 6, 9, and 12|Data was analyzed based on safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population||Kilograms||Standard Deviation|Mean
771254|NCT00723190|Primary|Change From Baseline in 12-lead Electrocardiogram in Terms of QT, QTc Fridericia (QTcF), and QTc Bazett’s (QTcB) at Week 4||At baseline and at Week 4|Data was analyzed based on safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population||milliseconds||Standard Deviation|Mean
771255|NCT00723190|Primary|Safety Assessment in Terms of Adverse Events (Treatment-emergent [TEAEs] and Serious [SAEs])|Safety assessments were performed at each study visit according to the time and events schedule. All safety analysis were based on safety population|1 year|The analysis of the safety data was performed for the safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population||Events|||Number
771272|NCT00723255|Secondary|Progression-Free Survival|Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.|Scans are done while patient is on study therapy every other cycle for the first 6 months; then every 3 cycles thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.|Eligible and Treated Patients||Months||95% Confidence Interval|Median
771273|NCT00723255|Primary|Progression-free Survival at 6 Months|Percentage of patients who are progression-free 6 months after study entry. Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.|Every other cycle for 6 months|Eligible and Treated Patients||percentage of participants||90% Confidence Interval|Number
771256|NCT00723190|Secondary|Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHDRS-IV Scale) (18 Items Scored, 0 [Never/Rarely] to 3 [Very Often]; Total Possible Score Range, 0-54) at Months 1, 2, 3, 4, 6, 9, and 12|The ADHDRS-IV consists of 18 items designed to reflect symptoms of ADHD. Each item is scored on a scale of 0 (Never or rarely) to 3 (Very Often). The subscales of the ADHDRS-IV included the Inattention and the hyperactivity/Impulsivity subscales (total possible score range, 0-54). The Inattention subscale consists of the sum of 9 items: 1, 3, 5, 7, 9, 11, 13, 15, and 17. The Hyperactivity/Impulsivity subscale consists of the sum of 9 items: 2, 4, 6, 8, 10, 12, 14, 16, and 18|At baseline, months 1, 2, 3, 4, 6, 9, and 12|Efficacy summaries and analyses are based on the efficacy evaluable population which included subjects who took one or more doses of study medication and had at least one post-baseline efficacy measurement||Units on a scale||Standard Deviation|Mean
771257|NCT00723190|Primary|Safety Assessment in Terms of Adverse Events (Treatment-emergent [TEAEs] and Serious [SAEs])|Safety assessments were performed at each study visit according to the time and events schedule. All safety analyses were based on safety population|1 year|The analysis of the safety data was performed for the safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population||Participants|||Number
771258|NCT00723203|Primary|Hematological Response Rate|Morphologic CR: morphologic leukemia-free state with absolute neutrophil count > 1000/uL and platelet count ≥ 100,000/uL and independent of blood transfusions. Cytogenic CR: morphologic CR along with reversion to a normal karyotype by cytogenetic analysis. Molecular CR: morphologic CR with no residual disease by molecular or flow cytometric detection methods. Morphologic CR with incomplete blood recovery (CRi): morphologic CR except for residual neutropenia (<1000/uL) and/or thrombocytopenia (<1000,000/uL). PR: same hematologic values for a CR but with a decrease of at least 50% in percentage of blasts to a post-treatment value of 5% to 25% in bone marrow aspirate. (If the pre-treatment blast percentage was 50-100% this must decrease to a value between 5-25%. If the pre-treatment blast percentage was 20-49% this must decrease by at least half to a value > 5%.) A value ≤ 5% is also considered a PR if Auer rods are present. Hematological response = morphologic CR+PR.|Up to 6 cycles of treatment, up to 24 weeks.|Three patients of the 16 accrued were not included in the analysis for response per protocol due to patient refusal for alternative treatment prior to completing the first cycle of treatment.||percentage of responding participants|||Number
771259|NCT00723229|Secondary|Duration of Genital HSV Shedding Episodes|Median duration of HSV shedding episodes, in hours|9 weeks|Only episodes of known duration were included||Hours|Episodes|Inter-Quartile Range|Median
771260|NCT00723229|Secondary|Number of Genital HSV Shedding Episodes|The number of HSV shedding episodes. A shedding episode is defined as any number of positive swabs preceded and followed by 2 negative swabs|9 weeks|The number of participants analyzed is the same as the overall number. No participants were excluded from this analysis.||Episodes|||Number
771261|NCT00723229|Secondary|Quantity of HSV Detected, Median|Median quantity of HSV detected, among swabs with any HSV detected|9 weeks|The number of swabs with HSV detected was analyzed. This is a subset of overall numbers of swabs collected, since not all swabs had HSV detected.||log 10 copies/ml|Swabs|Inter-Quartile Range|Median
771262|NCT00723229|Primary|Frequency of HSV-2 Total Shedding From the Genital Tract as Measured by PCR, Calculated Using a Per-day Shedding Rate in Participants Treated With Suppressive Acyclovir as Compared to no Medication in HIV Seronegative and HIV Seropositive Individuals.||9 weeks|Participants collected at least one swab on each study arm||percentage of swabs with HSV detected|Swabs||Number
771263|NCT00723255|Primary|Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0|Adverse event data are presented in the Adverse Event section of this report.|Up to 5 years||||||
771264|NCT00723255|Secondary|The Frequency and Severity of Adverse Effects as Assessed by CTCAE v3.0||Up to 5 years||||||
771265|NCT00723255|Secondary|Progression-free Survival at 6 Months by Tumor Grade|Percentage of patients who are progression-free 6 months after study entry. Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.|Every other cycle for 6 months|||percentage of participants||95% Confidence Interval|Number
771266|NCT00723255|Secondary|Complete and Partial Tumor Response by RECIST 1.0 by Tumor Grade|Complete and Partial Tumor Response by RECIST 1.0|Scans are done while patient is on study therapy every other cycle for the first 6 months; then every 3 cycles thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease|||percentage of participants||95% Confidence Interval|Number
771267|NCT00723255|Secondary|Progression-free Survival at 6 Months by Histologic Type|Percentage of patients who are progression-free 6 months after study entry. Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.|Every other cycle for 6 months|||percentage of participants||95% Confidence Interval|Number
771268|NCT00723255|Secondary|Complete and Partial Tumor Response by RECIST 1.0 by Histologic Type|Complete and Partial Tumor Response by RECIST 1.0|Scans are done while patient is on study therapy every other cycle for the first 6 months; then every 3 cycles thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease|||percentage of participants||95% Confidence Interval|Number
771269|NCT00723255|Secondary|Progression-free Survival at 6 Months by Performance Status|Percentage of patients who are progression-free 6 months after study entry. Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.|Every other cycle for 6 months|||percentage of participants||95% Confidence Interval|Number
771270|NCT00723255|Secondary|Complete and Partial Tumor Response by RECIST 1.0 by Performance Status|Complete and Partial Tumor Response by RECIST 1.0|Scans are done while patient is on study therapy every other cycle for the first 6 months; then every 3 cycles thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease|||percentage of participants||95% Confidence Interval|Number
771271|NCT00723255|Secondary|Overall Survival|The observed length of life from entry into the study to death or the date of last contact.|From entry into the study to death or the date of last contact, up to 5 years|Eligible and Treated Patients||Months||95% Confidence Interval|Median
771362|NCT00723554|Primary|Systolic Blood Pressure - Iloprost PD-15 (Period 3)|Systolic blood pressure was measured at the end of study visit|an average of approximately 268 days|Safety population - missing data were not imputed||mmHg||Standard Deviation|Mean
771274|NCT00723255|Primary|Tumor Response|Complete and Partial Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0|Scans are done while patient is on study therapy every other cycle for the first 6 months; then every 3 cycles thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease|Eligible and Treated Patients||percentage of participants||90% Confidence Interval|Number
771275|NCT00723294|Secondary|Pain Assessment||Up to 14 days post surgery||12/2017||||
771276|NCT00723294|Secondary|Adverse Events||Up to 14 days post surgery||12/2017||||
771277|NCT00723294|Secondary|Negative Predictive Value of MRI|Negative predictive value of MRI: The negative predictive rate of MRI will be estimated as the number of patients with no residual disease upon pathologic review of the resected tissue AND with a MRI that indicated no residual disease divided by the number of patients who had an MRI that indicated no residual disease. Both a binomial point estimate and 90% two-sided confidence interval will be computed.|Up to 14 days post cryoablation|One patient had bilateral disease and therefore outcomes are reported for 87 cancers.||percentage of cancers|cancers|90% Confidence Interval|Number
771278|NCT00723294|Primary|Rate of Complete Tumor Ablation|The primary endpoint for this study is the rate of complete ablation. Complete ablation is defined as no remaining invasive or in situ carcinoma present upon pathological examination of the targeted lesion. The rate (percentage) will be computed as the number of patient lesions with complete tumor ablation divided by the total number of eligible patient lesions. This rate will be estimated by the binomial point estimate (number of patients with no pathological evidence of residual disease in the targeted lesion after ablation divided by the number of eligible patients) and a one-sided 90% binomial confidence interval (interval with a lower bound).|Up to 14 days post surgery|One patient had bilateral disease and therefore outcomes are reported for 87 lesions.||percentage of lesions|lesions|90% Confidence Interval|Number
771279|NCT00723450|Secondary|Change From Randomization in the Conners’ Global Index – Parent Version (CGI-P) at Each Visit in the Randomized Phase.|The CGI-P is a 10-item scale used to assess attention deficit hyperactivity disorder (ADHD) symptoms in children and adolescents aged 3-17 years of age. The scale is composed of two factors: restless-impulsive behavior and emotional lability. Each item was scored on a 0-3 scale. The range of scores for the CGI-P is 0 (best possible outcome) to 30 (worst possible outcome). The CGI-P was completed by the participant’s custodial parent or legal guardian. Analysis was performed using mixed model repeated measures.|Randomization and Weeks 8, 16, 24, 32, and 36|Randomized ITT Population||Scores on a scale||Standard Error|Least Squares Mean
771280|NCT00723450|Secondary|Change From Baseline in the Conners’ Global Index – Parent Version (CGI-P) at Each Visit in the Open-Label Phase|The CGI-P is a 10-item scale used to assess attention deficit hyperactivity disorder (ADHD) symptoms in children and adolescents aged 3-17 years of age. The scale is composed of two factors: restless-impulsive behavior and emotional lability. Each item was scored on a 0-3 scale. The range of scores for the CGI-P is 0 (best possible outcome) to 30 (worst possible outcome). The CGI-P was completed by the participant’s custodial parent or legal guardian. Analysis was performed using mixed model repeated measures.|Baseline and Weeks 4, 8, 12, 16, and 18|Open-Label ITT Population||Scores on a scale||Standard Error|Least Squares Mean
771281|NCT00723450|Secondary|Change From Randomization in the Parent Version of the Young Mania Rating Scale (P-YMRS) at Each Visit in the Randomized Phase|The P-YMRS was adapted from the YMRS for completion by parents of the pediatric participants with bipolar disorder in order to assess the severity of the manic symptoms. The P-YMRS consisted of 11 items and had a total score range of 0 (best possible outcome) to 60 (worst possible outcome). The P-YMRS was completed by the participant's custodial parent or legal guardian. Analysis was performed using mixed model repeated measures.|Randomization and Weeks 8, 16, 24, 32, and 36|Randomized ITT Population||Scores on a scale||Standard Error|Least Squares Mean
771282|NCT00723450|Secondary|Change From Baseline in the Parent Version of the Young Mania Rating Scale (P-YMRS) at Each Visit in the Open-Label Phase|The P-YMRS was adapted from the YMRS for completion by parents of the pediatric participants with bipolar disorder in order to assess the severity of the manic symptoms. The P-YMRS consisted of 11 items and had a total score range of 0 (best possible outcome) to 60 (worst possible outcome). The P-YMRS was completed by the participant's custodial parent or legal guardian. Analysis was performed using mixed model repeated measures.|Baseline and Weeks 4, 8, 12, 16, and 18|Open-Label ITT Population||Scores on a scale||Standard Error|Least Squares Mean
771283|NCT00723450|Secondary|Change From Randomization in the Young Mania Rating Scale (YMRS) at Each Visit in the Randomized Phase|The YMRS consists of 11 items and is based on the participant's report of their mania symptoms. It is clinician rated. Four items (irritability, speech, thought content, and disruptive/aggressive behavior) are rated on a scale of 0 to 8, while the other seven items (elevated mood, increased motor activity-energy, sexual interest, sleep, language, appearance, and insight) are rated on a scale of 0 to 4. The range of scores for the YMRS is 0 (best possible outcome) to 60 (worst possible outcome). The YMRS was completed by the investigator or their qualified designee. Analysis was performed using mixed model repeated measures.|Randomization and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, and 36|Randomized ITT Population||Scores on a scale||Standard Error|Least Squares Mean
771284|NCT00723450|Secondary|Change From Baseline in the Young Mania Rating Scale (YMRS) at Each Visit in the Open-Label Phase|The YMRS consists of 11 items and is based on the participant's report of their mania symptoms. It is clinician rated. Four items (irritability, speech, thought content, and disruptive/aggressive behavior) are rated on a scale of 0 to 8, while the other seven items (elevated mood, increased motor activity-energy, sexual interest, sleep, language, appearance, and insight) are rated on a scale of 0 to 4. The range of scores for the YMRS is 0 (best possible outcome) to 60 (worst possible outcome). The YMRS was completed by the investigator or their qualified designee. Analysis was performed using mixed model repeated measures.|Baseline and Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18|Open-Label ITT Population||Scores on a scale||Standard Error|Least Squares Mean
771314|NCT00723528|Secondary|Change From Baseline in the Number of Nails With Psoriasis Involvement at Week 12, 28, 40, 52 and 64|The number of nails with psoriasis involvement was assessed by a dermatologist.|Week 12, 28, 40, 52 and 64|The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here, 'N' signifies the participants evaluated for this measure and 'n' signifies the participants evaluated for this measure at a particular time point.||Nails||Standard Deviation|Mean
771285|NCT00723450|Secondary|Number of Participants Considered Much Improved or Very Much Improved [Defined as a Clinical Global Impression-Bipolar Version, Improvement of Illness (CGI-BP[I]), Score of 1 or 2] at Each Visit Compared to Randomization in the Randomized Phase|The CGI-BP(I) asks the following question: “Compared to the Randomization assessment in this trial, how much has the participant changed?”. Scores on the CGI-I range from 1 (very much improved) to 7 (very much worse). The investigator or their designee rated improvement regardless of whether the improvement to be due to drug treatment. Improvement defined as CGI-BP(I)=1 (improved) or 2 (very much improved). Missing data imputed using last-observation carried forward (LOCF).|Randomization and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, and 36|Randomized ITT Population||Participants|||Number
771286|NCT00723450|Secondary|Number of Participants Considered Much Improved or Very Much Improved [Defined as a Clinical Global Impression-Bipolar Version, Improvement of Illness (CGI-BP[I]), Score of 1 or 2] at Each Visit Compared to Baseline in the Open-Label Phase|The CGI-BP(I) asks the following question: “Compared to the Baseline assessment in this trial, how much has the participant changed?”. Scores on the CGI-I range from 1 (very much improved) to 7 (very much worse). The investigator or their designee rated improvement regardless of whether the improvement to be due to drug treatment. Improvement defined as CGI-BP(I)=1 (improved) or 2 (very much improved). Missing data imputed using last-observation carried forward (LOCF).|Baseline and Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18|Open-Label ITT Population. Only those par. available at the specified time points were analyzed (represented by n=X). Different par. may have been analyzed at different time points, so the overall number of par. analyzed reflects everyone in the Open-Label Population.||Participants|||Number
771287|NCT00723450|Secondary|Summary of Clinical Global Impressions – Bipolar – Improvement of Illness (CGI-BP [I]) Scores During Randomized Phase|Improvement of bipolar illness was based on the CGI-BP(I) score which ranged from 1 (very much improved) to 7 (very much worse). Analysis was performed using mixed model repeated measures.|Randomization weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32 and 36|Randomized ITT Population. Only those par. available at the specified time points were analyzed (represented by n=X). Different par. may have been analyzed at different time points, so the overall number of par. analyzed reflects everyone in the Randomized ITT Population.||Scores on a scale||Standard Deviation|Mean
771288|NCT00723450|Secondary|Summary of Clinical Global Impressions – Bipolar – Improvement of Illness (CGI-BP [I]) Scores During Open-label Phase|Improvement of bipolar illness was based on the CGI-BP (I) score which ranged from 1 (very much improved) to 7 (very much worse). Analysis was performed using mixed model repeated measures.|Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18|Open-Label ITT Population. Only those par. available at the specified time points were analyzed (represented by n=X). Different par. may have been analyzed at different time points, so the overall number of par. analyzed reflects everyone in the Open-Label Population.||Scores on a scale||Standard Deviation|Mean
771289|NCT00723450|Secondary|Change From Randomization in the Clinical Global Impressions – Bipolar, Severity of Illness (CGI-BP[S]) at Each Visit in the Randomized Phase|Severity of the bipolar illness was based on the CGI-BP(S) score which had a range from 1 (normal, not ill) to 7 (very severely ill). Analysis was performed using mixed model repeated measures.|Randomization and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, and 36|Randomized ITT Population||Scores on a scale||Standard Error|Least Squares Mean
771290|NCT00723450|Secondary|Change From Baseline in the Clinical Global Impressions – Bipolar, Severity of Illness (CGI-BP[S]) at Each Visit in the Open-Label Phase|Severity of the bipolar illness was based on the CGI-BP(S) score which had a range from 1 (normal, not ill) to 7 (very severely ill). Analysis was performed using mixed model repeated measures.|Baseline and Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18|Open-Label ITT Population||Scores on a scale||Standard Error|Least Squares Mean
771291|NCT00723450|Secondary|Change From Randomization in the Quick Inventory of Depressive Symptomatology – Self-report Adolescent Version (QIDS-A17-SR) at Each Visit in the Randomized Phase|The QIDS-A17-SR is a 17-item scale used to assess depression severity in adolescents according to the DSM-IV-TR diagnostic criteria for a major depressive episode; it is a modified version of the Quick Inventory of Depressive Symptomatology (QIDS) used for adults. Each item is scored on a 0-3 scale, yielding 9 domain scores. The range of scores is 0 (best possible outcome) to 27 (worst possible outcome). The scale is completed by the participant. Analysis was performed using mixed model repeated measures.|Randomization and Weeks 8, 16, 24, 32, and 36|Randomized ITT Population||Scores on a scale||Standard Error|Least Squares Mean
771292|NCT00723450|Secondary|Change From Baseline in the Quick Inventory of Depressive Symptomatology – Self-report Adolescent Version (QIDS-A17-SR) at Each Visit in the Open-Label Phase|The QIDS-A17-SR is a 17-item scale used to assess depression severity in adolescents according to the DSM-IV-TR diagnostic criteria for a major depressive episode; it is a modified version of the Quick Inventory of Depressive Symptomatology (QIDS) used for adults. Each item is scored on a 0-3 scale, yielding 9 domain scores. The range of scores is 0 (best possible outcome) to 27 (worst possible outcome). The scale is completed by the participant. Analysis was performed using mixed model repeated measures.|Baseline and Weeks 4, 8, 12, 16, and 18|Open-Label ITT Population||Scores on a scale||Standard Error|Least Squares Mean
771293|NCT00723450|Secondary|Change From Randomization in the Quick Inventory of Depressive Symptomatology – Clinician Interview, Semi-structured, Adolescent Version (QIDS- A17-C) at Each Visit in the Randomized Phase|The QIDS-A17-C is a 17-item scale used to assess depression severity in adolescents according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) diagnostic criteria for a major depressive episode; it is a modified version of the Quick Inventory of Depressive Symptomatology (QIDS) used for adults. Each item is scored on a 0-3 scale, yielding 9 domain scores. The range of scores is 0 (best possible outcome) to 27 (worst possible outcome). Analysis was performed using mixed model repeated measures.|Randomization and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, and 36|Randomized ITT Population||Scores on a scale||Standard Error|Least Squares Mean
771339|NCT00723554|Secondary|Average Number of Daily Doses - Iloprost PD-15 (Period 3)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average of approximately 240 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.||doses per day||Standard Deviation|Mean
771294|NCT00723450|Secondary|Change From Baseline in the Quick Inventory of Depressive Symptomatology – Clinician Interview, Semi-structured, Adolescent Version (QIDS- A17-C) at Each Visit in the Open-Label Phase|The QIDS-A17-C is a 17-item scale used to assess depression severity in adolescents according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) diagnostic criteria for a major depressive episode; it is a modified version of the Quick Inventory of Depressive Symptomatology (QIDS) used for adults. Each item is scored on a 0-3 scale, yielding 9 domain scores. The range of scores is 0 (best possible outcome) to 27 (worst possible outcome). Analysis was performed using mixed model repeated measures.|Baseline and Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18|Open-Label ITT population: all participants who entered the Open-Label Phase and received at least one dose of LTG.||Scores on a Scale||Standard Error|Least Squares Mean
771295|NCT00723450|Secondary|Number of Participants Experiencing a Relapse/Recurrence Within the First 30, 90, and 180 Days in the Randomized Phase|The proportion of participants (par.) requiring intervention to treat either the emergence of or a change in bipolar symptoms, that is, experiencing a relapse/recurrence to depression, mania/hypomania, or mixed mood state at any time within the first 30, 90, and 180 days in the Randomized Phase were analyzed.|From randomization up to Week 36|Randomized ITT Population. Only those participants requiring intervention to treat either the emergence of, or a change, in bipolar symptoms were analyzed.||Participants|||Number
771296|NCT00723450|Secondary|Number of Participants Experiencing a Relapse/Recurrence to Depression, Mania/Hypomania, or Mixed Mood State|The number of participants requiring intervention to treat either the emergence of or a change in bipolar symptoms that is, experiencing a relapse/recurrence to depression, mania/hypomania, or mixed mood state were analyzed.|From randomization until a relapse/recurrence to depression, mania/hypomania, or mixed mood state (up to Week 36)|Randomized ITT Population. Only those participants requiring intervention to treat either the emergence of, or a change, in bipolar symptoms were analyzed.||Participants|||Number
771297|NCT00723450|Secondary|Time From Randomization to Intervention for Depression (TIDep), Mania/Hypomania (TIMan), or a Mixed Episode (TIMix)|The time from randomization to intervention for depression (TIDep), mania/hypomania (TIMan), or a mixed episode (TIMix) was analyzed. TIDep, TIMan, and TIMix were calculated using the log rank test with stratification for index mood state (depression, mania/hypomania, mixed mood).|From randomization until intervention administered for depression, mania/hypomania or a mixed episode (up to Week 36)|Randomized ITT Population||Days||Standard Error|Mean
771298|NCT00723450|Secondary|Time From Randomization to Intervention for a Mood Episode (TIME)|The time from randomization to the intervention for a mood episode (depression, mania/hypomania or mixed mood) was analyzed. TIME was calculated using the log rank test with stratification for index mood state (depression, mania/hypomania, mixed mood).|From randomization until intervention administered for a mood episode (up to Week 36)|Randomized ITT Population||Days||Standard Error|Mean
771299|NCT00723450|Secondary|Time From Randomization to Withdrawal From the Study for Any Cause (TTW)|The time from randomization to the withdrawal from study was analyzed. TTW was calculated using the log rank test with stratification for index mood state (depression, mania/hypomania, mixed mood).|From randomization until withdrawal from the study for any cause (up to Week 36)|Randomized ITT Population||Days||Standard Error|Mean
771300|NCT00723450|Primary|Time From Randomization to the Occurrence of a Bipolar Event (TOBE)|TOBE was defined by the first prescription of any additional pharmacotherapy to treat bipolar symptoms, increasing the dose(s) of the participants conventional bipolar medication(s), treatment with electroconvulsive therapy, or moving the participant to a more restricted environment for observation, safety, or treatment; or participant withdrawal from the study due to a bipolar-related adverse event (AE) or serious adverse event (SAE); or participants withdrawal from the study due to lack of efficacy as defined by rating scale threshold scores. TOBE was calculated using a log rank test with stratification for index mood state (depression, mania/hypomania, mixed mood).|From randomization until Week 36|Randomized Intent-to-Treat (ITT) Population: all participants who were randomized to LTG or placebo and received at least one dose of investigational product.||Days||Standard Error|Mean
771301|NCT00723489|Secondary|Comparison in Log10 Transformed Lymphocyte Count on Day 30 Post YF Immunization: IFN-gamma Positive, Tumor Necrosis Factor- Alpha (TNF Alpha) Positive, CD8 Positive T-cells, YFV-17D TC – (AD) Compared to YFV-17D TC – (Non-AD) Participants|Comparison by designated reporting groups: the Log10 transformed count of CD8 Positive T-cells expressing IFN-gamma and TNF-alpha in every 10^6 CD8 Positive T-cells.|Day 30 (Day 28-35)|Participants who did not seroconvert were excluded from this analysis (2 TC-(AD) and 5 TC-(Non-AD)). T-cell data from 4 TC-(AD) and 3 TC-(Non-AD) subjects was excluded due to problems with sample processing||Log10 cell count/10^6 cells||Standard Deviation|Mean
771302|NCT00723489|Secondary|Comparison in Log10 Transformed Lymphocyte Count on Day 30 Post YF Immunization: IFN-gamma Positive, Tumor Necrosis Factor- Alpha (TNF Alpha) Positive, CD8 Positive T-cells, YFV-17D SC –(AD) Compared to YFV-17D SC – (Non-AD) Participants|Comparison by designated reporting groups: the Log10 transformed lymphocyte count of CD8 Positive T-cells expressing IFN-gamma and TNF-alpha in every 10^6 CD8 Positive T-cells.|Day 30 (Day 28-35)|Analysis excludes 1 SC-(AD) participant who did not seroconvert, 1 SC-(AD) participant whose samples were collected out of window, and 3 SC (Non-AD) and 1 SC-(AD) due to problems with sample processing||Log10 cell count/10^6 cells||Standard Deviation|Mean
771303|NCT00723489|Secondary|Comparison in Log10 Transformed Lymphocyte Count on Day 30 Post YF Immunization: IFN-gamma Positive, Tumor Necrosis Factor- Alpha (TNF Alpha) Positive , CD4 Positive T-cells, YFV-17D TC – (AD) Compared to YFV-17D TC – (Non-AD) Participants|Comparison by designated reporting groups: the Log10 transformed count of CD4 Positive T-cells that express IFN-gamma and TNF-alpha in every 10^6 CD4 Positive T- Cells (Day 30). A higher count reflects a better immune response to Yellow Fever virus.|Day 30 (Day 28-35)|Participants who did not seroconvert were excluded from this analysis (2 TC-(AD) and 5 TC-(Non-AD)). T-cell data from 4 TC-(AD) and 3 TC-(Non-AD) subjects was excluded due to problems with sample processing||Log10 cell count/10^6 cells||Standard Deviation|Mean
771340|NCT00723554|Secondary|Average Number of Daily Doses - Iloprost PD-15 (Period 2)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average of approximately 28 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.||doses per day||Standard Deviation|Mean
771304|NCT00723489|Secondary|Comparison in Log10 Transformed Lymphocyte Count on Day 30 Post YF Immunization: IFN-gamma Positive, Tumor Necrosis Factor- Alpha (TNF Alpha) Positive, CD4 Positive T-cells, YFV-17D SC – (AD) Compared to YFV-17D SC – (Non- AD) Participants|Comparison by designated reporting groups: the Log10 transformed lymphocyte count of CD4 Positive T-cells expressing IFN-gamma and TNF-alpha in every 10^6 CD4 Positive T-cells on Day 30 (acceptable blood draw window: Day 28 – 35).|Day 30 (Day 28-35)|Analysis excludes 1 SC-(AD) participant who did not seroconvert, 1 SC-(Non-AD) participant whose samples were collected out of window, and 3 SC (Non-AD) and 1 SC-(AD) due to problems with sample processing||Log10 cell count/10^6 cells||Standard Deviation|Mean
771305|NCT00723489|Secondary|Comparison of Count of Seroconverters: YFV-17D SC – (AD) Participants Compared to YFV-17D SC – (Non-AD) Participants|Seroconversion is defined as a Log10 Neutralization Index (LNI) of 0.7 or higher. A value greater than or equal to 0.7 suggests that a person has active immunity against Yellow Fever virus.|Day 0 to Day 30 (Acceptable Post-Vaccination Blood Draw Range: Day 28 - Day 35)|Includes all participants who completed the study; seroconverters as well as non-seroconverters||participants|||Number
771306|NCT00723489|Secondary|Comparison of Count of Seroconverters: YFV-17D TC– (AD) Participants Compared to YFV-17D TC – (Non-AD) Participants|Seroconversion is defined as a Log10 Neutralization Index (LNI) of 0.7 or higher. A value greater than or equal to 0.7 suggests that a person has active immunity against Yellow Fever virus.|Day 0 to Day 30 (Acceptable Post-Vaccination Blood Draw Range: Day 28 - Day 35)|Includes all participants who completed the study; seroconverters as well as non-seroconverters||participants|||Number
771307|NCT00723489|Primary|Comparison of Anti-YF Antibody Levels by Measurement of Log10 Neutralizing Titer 50 (NT50): YFV-17D SC – (AD) Participants Compared to YFV-17D SC – (Non-AD) Participants|Neutralization titer (NT50) is the dilution of serum (antibody) that results in a 50% reduction in the amount of virus. A higher NT50 number reflects the presence of more protective antibody levels against the Yellow Fever virus. Some studies have used an NT50 titer of 1:10 or 1:20 as the minimum level to suggest that a person has active immunity against the Yellow Fever virus.|30 days after Yellow Fever (YF) immunization (Acceptable Blood Draw Range: Day 28 - Day 35 after YF immunization)|All participants who completed the study; and seroconverted||Log10 (NT50)||Standard Deviation|Mean
771308|NCT00723489|Primary|Comparison of Anti-YF Antibody Levels by Measurement of Log10 Neutralizing Titer 50 (NT50): YFV-17D TC – (AD) Participants Compared to YFV-17D TC – (Non – AD) Participants|Neutralization titer (NT50) is the dilution of serum (antibody) that results in a 50% reduction in the amount of virus. A higher NT50 number reflects the presence of more protective antibody levels against the Yellow Fever virus. Some studies have used an NT50 titer of 1:10 or 1:20 as the minimum level to suggest that a person has active immunity against the Yellow Fever virus.|30 days after Yellow Fever (YF) immunization (Acceptable Blood Draw Range: Day 28 - Day 35 after YF immunization)|All participants who completed the study; and seroconverted||Log10 (NT50)||Standard Deviation|Mean
771309|NCT00723489|Primary|Comparison of Anti-YF Antibody Levels by Measurement of Log10 Neutralization Index (LNI): YFV-17D SC – (AD) Participants Compared to YFV-17D SC– (Non-AD) Participants|Log10 Neutralization Index (LNI) is the Log10 difference in virus titer (measurement of amount of virus) between pre-vaccination and post-vaccination. An LNI greater than or equal to 0.7 suggests that a person has active immunity against Yellow Fever virus.|30 days after YF immunization (Acceptable Blood Draw Range: Day 28 - Day 35 after Yellow Fever immunization)|All participants who completed the study; and seroconverted||Log10 Neutralization Index (LNI)||Standard Deviation|Mean
771310|NCT00723489|Primary|Comparison of Anti-YF Antibody Levels by Measurement of Log10 Neutralization Index (LNI): YFV-17D TC– (AD) Participants Compared to YFV-17D TC– (Non-AD) Participants|Log10 Neutralization Index (LNI) is the Log10 difference in virus titer (measurement of amount of virus) between pre-vaccination and post-vaccination. An LNI greater than or equal to 0.7 suggests that a person has active immunity against Yellow Fever virus.|30 days after Yellow Fever (YF) immunization (Acceptable Blood Draw Range: Day 28 - Day 35 after YF immunization)|All participants who completed the study; and seroconverted||LNI||Standard Deviation|Mean
771311|NCT00723528|Secondary|Percentage of Participants With Cleared (0), Cleared or Minimal (0 or 1) and Mild (Less Than or Equal to 2) Physician's Global Assessment (PGA) Score at Week 64|Percentage of participants with PGA score of cleared (0), cleared or minimal (0 or 1) and mild (less than or equal to 2) was reported. The PGA score is a numeric scale which is completed by the physician and is designed to evaluate the physician's overall assessment of the participant's psoriasis. Overall lesions will be graded for induration (I), erythema (E), and scaling (S) as: 0=cleared, 1=minimal, 2=mild, 3=moderate, 4=marked, and 5=severe. The sum of the 3 scores (I + E + S) will be divided by 3 to obtain a final PGA score ranging from 0 [best] to 5 [worst].|Week 64|The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here, 'N' signifies the participants evaluated for this measure.||Percentage of participants|||Number
771312|NCT00723528|Secondary|Percentage of Participants With Cleared (0), Cleared or Minimal (0 or 1) and Mild (Less Than or Equal to 2) Physician's Global Assessment (PGA) Score at Week 12|Percentage of participants with PGA score of cleared (0), cleared or minimal (0 or 1) and mild (less than or equal to 2) was reported. The PGA score is a numeric scale which is completed by the physician and is designed to evaluate the physician's overall assessment of the participant's psoriasis. Overall lesions will be graded for induration (I), erythema (E), and scaling (S) as: 0=cleared, 1=minimal, 2=mild, 3=moderate, 4=marked, and 5=severe. The sum of the 3 scores (I + E + S) will be divided by 3 to obtain a final PGA score ranging from 0 [best] to 5 [worst].|Week 12|The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication.||Percentage of participants|||Number
771313|NCT00723528|Secondary|Change From Baseline in Joint Symptoms Expressed on a Visual Analogue Scale (VAS) at Week 12, 28, 40, 52 and 64|Each participant will assess his/her pain associated with joint symptoms on each assessment day using a 100 mm VAS ranging from 0 mm (no pain) to 100 mm (the worst pain imaginable).|Week 12, 28, 40, 52 and 64|The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here, 'N' signifies the participants evaluated for this measure and 'n' signifies the participants evaluated for this measure at a particular time point.||Unit on scale||Standard Deviation|Mean
771315|NCT00723528|Secondary|Treatment Response Based on Nail Psoriasis Severity Index (NAPSI) Score|The NAPSI score is used to evaluate the severity of nail bed psoriasis and nail matrix psoriasis. The nail is divided with into quadrants and given a score for nail bed psoriasis (0-4) and nail matrix psoriasis (0-4) depending on the presence of any of the features of nail psoriasis in that quadrant. Each nail is evaluated, and the sum of all the nails is the total NAPSI score. The sum of the scores from all nails ranges from 0 (no psoriasis) to 80 (psoriasis present in all 4 quadrants of all 10 nails).|Week 12, 28, 40,52 and 64|The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here, 'N' signifies the participants evaluated for this measure and 'n' signifies the participants evaluated for this measure at a particular time point.||Unit on scale||Standard Deviation|Mean
771316|NCT00723528|Secondary|Change From Baseline in Psoriasis Disability Index (PDI) Score at Week 12, 28, 40, 52 and 64|The PDI questionnaire consists of 15 questions relating to the impact of psoriasis in terms of daily activities, work or school, personal relationships, leisure, and treatment. Each question is scored on a scale of 0 (no impact) to 3 (greatest impact). The PDI is calculated by summing the scores of the questions resulting in a maximum score of 45 (greatest impact) and a minimum score of 0 (no impact).|Week 12, 28, 40, 52 and 64|The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here, 'N' signifies the participants evaluated for this measure and 'n' signifies the participants evaluated for this measure at a particular time point.||Unit on scale||Standard Deviation|Mean
771317|NCT00723528|Secondary|Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Week 12, 28, 40, 52 and 64|The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: (1) physical component summary (PCS)=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary (MCS)=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both sub scores and summary scores. For sub scores and summary scores: 0=worst score and 100=best score.|Week 12, 28, 40, 52 and 64|The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here, 'N' signifies the participants evaluated for this measure and 'n' signifies the participants evaluated for this measure at a particular time point.||Unit on scale||Standard Deviation|Mean
771318|NCT00723528|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 28, 40, 52 and 64|The DLQI is a self-administered 10-item questionnaire that is used to assess 6 different aspects of quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Scores range from 0 (no impairment in quality of life) to 30 (most impairment in quality of life).|Week 28, 40, 52 and 64|The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here,'N' signifies the participants evaluated for this measure and 'n' signifies the participants evaluated for this measure at a particular time point.||Unit on scale||Standard Deviation|Mean
771319|NCT00723528|Secondary|Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%), 90%, and Equal to 100% of Treatment Response Based on PASI Score|PASI is a widely used tool for the measurement of severity of psoriasis. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) to 72 (worst). Percentage of Treatment Response= (Baseline PASI score-PASI score after treatment)/Baseline PASI score x 100. Baseline visit refers to Week 0.|Week 64|The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here, 'N' signifies the participants evaluated for this measure.||Percentage of participants|||Number
771320|NCT00723528|Secondary|Percentage of Treatment Response Based on Psoriasis Area and Severity Index (PASI) Score|PASI is a widely used tool for the measurement of severity of psoriasis. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) to 72 (worst). Percentage of Treatment Response= (Baseline PASI score-PASI score after treatment)/Baseline PASI score x 100. Baseline visit refers to Week 0.|Week 64|The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here,'N' signifies the participants evaluated for this measure.||Percentage of treatment response||Standard Deviation|Mean
771321|NCT00723528|Secondary|Psoriasis Area and Severity Index (PASI) Score|PASI is a widely used tool for the measurement of severity of psoriasis. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) to 72 (worst).|Week 64|The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here,'N' signifies the participants evaluated for this measure.||Units on a scale||Standard Deviation|Mean
771322|NCT00723528|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 12|The DLQI is a self-administered 10-item questionnaire that is used to assess 6 different aspects of quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Scores range from 0 (no impairment in quality of life) to 30 (most impairment in quality of life).|Week 12|"The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. N (number of participants analyzed) signifies the participants evaluable for this measure."||Units on scale||Standard Deviation|Mean
771323|NCT00723528|Primary|Percentage of Participants With Greater Than or Equal to 75 Percent (%) Improvement in Psoriasis Area and Severity Index (PASI) Score|Percentage of participants with >=75% improvement in PASI score at Week 12 from Baseline was reported. PASI is a widely used tool for the measurement of severity of psoriasis. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) to 72 (worst). Baseline visit refers to Week 0.|Week 12|The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication.||Percentage of participants|||Number
771324|NCT00723554|Secondary|Number of Patients With Improved, no Change, or Worse Patient Global Self Assessment - Change From Previous Visit to Period 3, End of Study Visit|"The Patient Global Self Assessment is a 7-point scale that was presented to patients prior to conducting visit-specific study procedures. Patients were asked to compare their current PAH status to their status in the past by selecting one of the following options: markedly better; moderately better; mildly better; no change; mildly worse; moderately worse; or markedly worse.
On Day 1 prior to their first dose of iloprost with PD-15 (Baseline), patients were asked to compare their PAH status to that during Screening (if the Screening and Baseline visits were conducted on the same day, then patients were asked to compare their PAH status to that in the past 2 weeks). On Day 28 and at the EOS visit, patients were asked to compare their PAH status to that of the previous visit."|average of approximately 268 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.||participants|||Number
771325|NCT00723554|Secondary|Number of Patients With Improved, no Change, or Worse Patient Global Self Assessment - Change From Previous Visit to Period 2, Day 28|"The Patient Global Self Assessment is a 7-point scale that was presented to patients prior to conducting visit-specific study procedures. Patients were asked to compare their current PAH status to their status in the past by selecting one of the following options: markedly better; moderately better; mildly better; no change; mildly worse; moderately worse; or markedly worse.
On Day 1 prior to their first dose of iloprost with PD-15 (Baseline), patients were asked to compare their PAH status to that during Screening (if the Screening and Baseline visits were conducted on the same day, then patients were asked to compare their PAH status to that in the past 2 weeks). On Day 28 and at the EOS visit, patients were asked to compare their PAH status to that of the previous visit."|average of approximately 28 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.||participants|||Number
771326|NCT00723554|Secondary|Patient Global Self Assessment - Iloprost PD-15 (Period 3, End of Study Visit))|"The Patient Global Self Assessment is a 7-point scale that was presented to patients prior to conducting visit-specific study procedures. Patients were asked to compare their current PAH status to their status in the past by selecting one of the following options: markedly better; moderately better; mildly better; no change; mildly worse; moderately worse; or markedly worse.
On Day 1 prior to their first dose of iloprost with PD-15 (Baseline), patients were asked to compare their PAH status to that during Screening (if the Screening and Baseline visits were conducted on the same day, then patients were asked to compare their PAH status to that in the past 2 weeks). On Day 28 and at the EOS visit, patients were asked to compare their PAH status to that of the previous visit."|average of approximately 268 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.||participants|||Number
771327|NCT00723554|Secondary|Patient Global Self Assessment - Iloprost PD-15 (Period 2, Day 28)|"The Patient Global Self Assessment is a 7-point scale that was presented to patients prior to conducting visit-specific study procedures. Patients were asked to compare their current PAH status to their status in the past by selecting one of the following options: markedly better; moderately better; mildly better; no change; mildly worse; moderately worse; or markedly worse.
On Day 1 prior to their first dose of iloprost with PD-15 (Baseline), patients were asked to compare their PAH status to that during Screening (if the Screening and Baseline visits were conducted on the same day, then patients were asked to compare their PAH status to that in the past 2 weeks). On Day 28 and at the EOS visit, patients were asked to compare their PAH status to that of the previous visit."|average of approximately 28 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.||participants|||Number
771328|NCT00723554|Secondary|Patient Global Self Assessment - Iloprost PD-6 (Period 1, Prior to First Dose With Iloprost PD-15)|"The Patient Global Self Assessment is a 7-point scale that was presented to patients prior to conducting visit-specific study procedures. Patients were asked to compare their current PAH status to their status in the past by selecting one of the following options: markedly better; moderately better; mildly better; no change; mildly worse; moderately worse; or markedly worse.
On Day 1 prior to their first dose of iloprost with PD-15 (Baseline), patients were asked to compare their PAH status to that during Screening (if the Screening and Baseline visits were conducted on the same day, then patients were asked to compare their PAH status to that in the past 2 weeks). On Day 28 and at the end of study (EOS) visit, patients were asked to compare their PAH status to that of the previous visit."|average of approximately 28 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.||participants|||Number
771329|NCT00723554|Secondary|Number of Patients With Improved, no Change, or Worsening of NYHA Functional Class - (Period 1, Prior to First Dose With Iloprost PD-15 to Period 3, End of Study Visit)|Disease severity was assessed by NYHA classification of PAH criteria: Class I: no limitation of physical activity (PA). Ordinary PA: no undue dyspnea/fatigue, chest pain, near syncope. Class II: slight limitation of PA. Comfortable at rest. Ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class III: marked limitation of PA. Comfortable at rest. Less than ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class IV: inability to carry out PA without symptoms. Right heart failure. Dyspnea/fatigue may even have been present at rest. Discomfort increased by any PA.|average approximately 268 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.||participants|||Number
771341|NCT00723554|Secondary|Average Number of Daily Doses - Iloprost PD-6 (Period 1)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average of approximately 28 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.||doses per day||Standard Deviation|Mean
771330|NCT00723554|Secondary|Number of Patients With Improved, no Change, or Worsening of NYHA Functional Class - (Period 1, Prior to First Dose With Iloprost PD-15 to Period 2, Day 28)|Disease severity was assessed by NYHA classification of PAH criteria: Class I: no limitation of physical activity (PA). Ordinary PA: no undue dyspnea/fatigue, chest pain, near syncope. Class II: slight limitation of PA. Comfortable at rest. Ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class III: marked limitation of PA. Comfortable at rest. Less than ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class IV: inability to carry out PA without symptoms. Right heart failure. Dyspnea/fatigue may even have been present at rest. Discomfort increased by any PA.|average approximately 28 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.||participants|||Number
771331|NCT00723554|Secondary|NYHA Functional Class - Iloprost PD-15 (Period 3, End of Study Visit))|Disease severity was assessed by NYHA classification of PAH criteria: Class I: no limitation of physical activity (PA). Ordinary PA: no undue dyspnea/fatigue, chest pain, near syncope. Class II: slight limitation of PA. Comfortable at rest. Ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class III: marked limitation of PA. Comfortable at rest. Less than ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class IV: inability to carry out PA without symptoms. Right heart failure. Dyspnea/fatigue may even have been present at rest. Discomfort increased by any PA.|average of approximately 268 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.||participants|||Number
771332|NCT00723554|Secondary|NYHA Functional Class - Iloprost PD-15 (Period 2, Day 28)|Disease severity was assessed by NYHA classification of PAH criteria: Class I: no limitation of physical activity (PA). Ordinary PA: no undue dyspnea/fatigue, chest pain, near syncope. Class II: slight limitation of PA. Comfortable at rest. Ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class III: marked limitation of PA. Comfortable at rest. Less than ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class IV: inability to carry out PA without symptoms. Right heart failure. Dyspnea/fatigue may even have been present at rest. Discomfort increased by any PA.|average of approximately 28 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.||participants|||Number
771333|NCT00723554|Secondary|New York Health Association (NYHA) Functional Class - Iloprost PD-6 (Period 1, Prior to First Dose With Iloprost PD-15)|Disease severity was assessed by NYHA classification of PAH criteria: Class I: no limitation of physical activity (PA). Ordinary PA: no undue dyspnea/fatigue, chest pain, near syncope. Class II: slight limitation of PA. Comfortable at rest. Ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class III: marked limitation of PA. Comfortable at rest. Less than ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class IV: inability to carry out PA without symptoms. Right heart failure. Dyspnea/fatigue may even have been present at rest. Discomfort increased by any PA.|average of approximately 28 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.||participants|||Number
771334|NCT00723554|Secondary|Change in Percentage of Complete Doses Delivered - (Period 1 to Period 2)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average approximately 56 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.||percentage of complete doses||Standard Deviation|Mean
771335|NCT00723554|Secondary|Percentage of Complete Doses Delivered - Iloprost PD-15 (Period 3)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average of approximately 240 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.||percentage of complete doses||Standard Deviation|Mean
771336|NCT00723554|Secondary|Percentage of Complete Doses Delivered - Iloprost PD-15 (Period 2)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average of approximately 28 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.||percentage of complete doses||Standard Deviation|Mean
771337|NCT00723554|Secondary|Percentage of Complete Doses Delivered - Iloprost PD-6 (Period 1)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average of approximately 28 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.||percentage of complete doses||Standard Deviation|Mean
771338|NCT00723554|Secondary|Change in Average Number of Daily Doses - (Period 1 to Period 2)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average approximately 56 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.||doses per day||Standard Deviation|Mean
771359|NCT00723554|Primary|Diastolic Blood Pressure - Iloprost PD-6 (Period 1)|Diastolic blood pressure was measured immediately prior to first dosing with Iloprost PD-15|Day 1|||mmHg||Standard Deviation|Mean
771363|NCT00723554|Primary|Systolic Blood Pressure - Iloprost PD-15 (Period 2)|Systolic blood pressure was measured on Day 28 of treatment with Iloprost PD-15|Day 28|Safety population - missing data were not imputed||mmHg||Standard Deviation|Mean
771342|NCT00723554|Secondary|Change in Average Number of Days of Dosing - (Period 1 to Period 2)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average approximately 56 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.||days||Standard Deviation|Mean
771343|NCT00723554|Secondary|Average Number of Days of Dosing - Iloprost PD-15 (Period 3)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average of approximately 240 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.||days||Standard Deviation|Mean
771344|NCT00723554|Secondary|Average Number of Days of Dosing - Iloprost PD-15 (Period 2)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average of approximately 28 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.||days||Standard Deviation|Mean
771345|NCT00723554|Secondary|Average Number of Days of Dosing - Iloprost PD-6 (Period 1)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average of approximately 28 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.||days||Standard Deviation|Mean
771346|NCT00723554|Secondary|Change in Average Inhalation Time - (Period 1 to Period 2)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average approximately 56 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.||minutes||Standard Deviation|Mean
771347|NCT00723554|Secondary|Average Inhalation Time - Iloprost PD-15 (Period 3)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average of approximately 240 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.||minutes||Standard Deviation|Mean
771348|NCT00723554|Secondary|Average Inhalation Time - Iloprost PD-15 (Period 2)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average of approximately 28 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.||minutes||Standard Deviation|Mean
771349|NCT00723554|Secondary|Average Inhalation Time - Iloprost PD-6 (Period 1)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average of approximately 28 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.||minutes||Standard Deviation|Mean
771350|NCT00723554|Primary|Change in Heart Rate - (Period 1 to Period 3)|Heart rate was measured on Day 1 prior to treatment with Iloprost PD-15 (Period 1) and at the end of treatment with Iloprost PD-15 (Period 3)|Day 1 and End of study visit, an average of approximately 268 days|Safety population - missing data were not imputed||beats per minute||Standard Deviation|Mean
771351|NCT00723554|Primary|Change in Heart Rate - (Period 1 to Period 2)|Heart rate was measured on Day 1 prior to treatment with Iloprost PD-15 (Period 1) and Day 28 of treatment with Iloprost PD-15 (Period 2)|Day 1 and Day 28|Safety population - missing data were not imputed||beats per minute||Standard Deviation|Mean
771352|NCT00723554|Primary|Heart Rate - Iloprost PD-15 (Period 3)|Heart rate was measured at the end of study visit|an average of approximately 268 days|Safety population - missing data were not imputed||beats per minute||Standard Deviation|Mean
771353|NCT00723554|Primary|Heart Rate - Iloprost PD-15 (Period 2)|Heart rate was measured on Day 28 of treatment with Iloprost PD-15|Day 28|Safety population - missing data were not imputed||beats per minute||Standard Deviation|Mean
771354|NCT00723554|Primary|Heart Rate - Iloprost PD-6 (Period 1)|Heart rate was measured immediately prior to first dosing with Iloprost PD-15|Day 1|Safety population||beats per minute||Standard Deviation|Mean
771355|NCT00723554|Primary|Change in Diastolic Blood Pressure - (Period 1 to Period 3)|Diastolic blood pressure was measured on Day 1 prior to treatment with Iloprost PD-15 (Period 1) and at the end of treatment with Iloprost PD-15 (Period 3)|Day 1 and End of study visit, an average of approximately 268 days|Safety population - missing data were not imputed||mmHg||Standard Deviation|Mean
771356|NCT00723554|Primary|Change in Diastolic Blood Pressure - (Period 1 to Period 2)|Diastolic blood pressure was measured on Day 1 prior to treatment with Iloprost PD-15 (Period 1) and Day 28 of treatment with Iloprost PD-15 (Period 2)|Day 1 and Day 28|Safety population - missing data were not imputed||mmHg||Standard Deviation|Mean
771357|NCT00723554|Primary|Diastolic Blood Pressure - Iloprost PD-15 (Period 3)|Diastolic blood pressure was measured at the end of study visit|an average of approximately 268 days|Safety population - missing data were not imputed||mmHg||Standard Deviation|Mean
771358|NCT00723554|Primary|Diastolic Blood Pressure - Iloprost PD-15 (Period 2)|Diastolic blood pressure was measured on Day 28 of treatment with Iloprost PD-15|Day 28|Safety population - missing data were not imputed||mmHg||Standard Deviation|Mean
771366|NCT00723554|Primary|Number of Patients Who Discontinued Iloprost PD-15 Treatment Due to an AE|Number of patients reporting at least one treatment-emergent AE/Serious AE leading to discontinuation of study investigational treatment|From the first dose of investigational product to study discontinuation, an average of approximately 268 days|Safety population||participants|||Number
771367|NCT00723554|Primary|Number of Patients Reporting Treatment-emergent Adverse Events (AEs)|Number of patients reporting at least one treatment-emergent AE/Serious AE|From the first dose to last dose of investigational product, an average of approximately 268 days, plus 48 hours|Safety population||participants|||Number
771368|NCT00723580|Secondary|The Personality Inventory for Children: Family Relations Scale|The factors that underlie this scale are family stability, inter-parent communication, presence of love and happiness in the home and appropriateness of discipline. The Personality Inventory for Children (PIC) is an age and gender referenced objective multidimensional measurement of affect, behavior, ability and family function.|May-7-2008 to July -14-2010||||||
771369|NCT00723580|Secondary|The Personality Inventory for Children: Social Skills Scale|The factors that underlie this scale are social success, social rejection, adults as only social contacts, and the ability to lead and follow. The Personality Inventory for Children (PIC) is an age and gender referenced objective multidimensional measurement of affect, behavior, ability and family function.|May-7-2008 to July -14-2010||||||
771370|NCT00723580|Secondary|The Personality Inventory for Children: Withdrawal Scale|The factors that underlie this scale are physical isolation, Shyness, isolation from peers, emotional distance and isolated intellectual interests. The Personality Inventory for Children (PIC) is an age and gender referenced objective multidimensional measurement of affect, behavior, ability and family function|May-7-2008 to July -14-2010||||||
771371|NCT00723580|Secondary|The Personality Inventory for Children: Delinquency Scale|The factors that underlie this scale are poor frustration tolerance, irritability, sadness, lack of interest, hostility,limited social participation and resistance to authority. The Personality Inventory for Children (PIC) is an age and gender referenced objective multidimensional measurement of affect, behavior, ability and family function.|May 7, 2008-July 14,2010||||||
771372|NCT00723580|Secondary|The Personality Inventory for Children: Somatic-Physiological Scale|The factors that underlie this scale are fatigue, aches and pains, insomnia, somatic response to stress and malingering. The Personality Inventory for Children (PIC) is an age and gender referenced objective multidimensional measurement of affect, behavior, ability and family function.|May-7-2008 to July -14-2010||||||
771373|NCT00723580|Secondary|The Personality Inventory for Children: Achievement Scale|The factors that underlie this scale are academic ability, poor achievement, impulsivity, limited concentration and over or under-assertiveness with peers. The Personality Inventory for Children (PIC) is an age and gender referenced objective multidimensional measurement of affect, behavior, ability and family function.|May-7-2008 to July -14-2010||||||
771374|NCT00723580|Secondary|The Personality Inventory for Children: Adjustment Scale|This scale measures general personality adjustment reflecting a dimension associated with highly adaptive to maladaptive adjustment. The Personality Inventory for Children (PIC) is an age and gender referenced objective multidimensional measurement of affect, behavior, ability and family function. The PIC was administered prior to treatment with risperidone and repeated after 22 months of treatment. The PIC serves as both an actuarial pre-treatment diagnostic tool as well as a post-treatment repeated measurement indicating treatment and developmentally associated change.|May-7-2008 to July -14-2010||||||
771375|NCT00723580|Secondary|Systematic Observation Scale: Percentage of Hyperactivity Observed||May-7-2008 to July -14-2010||||||
771376|NCT00723580|Secondary|Systematic Observation Scale: Percentage of Distractibility Observed||May-7-2008 to July -14-2010||||||
771377|NCT00723580|Secondary|Systematic Observation Scale: Percentage of Irritability Observed||May-7-2008 to July -14-2010||||||
771378|NCT00723580|Secondary|Systematic Observation Scale Item: Percentage of Impulsivity Observed|The Systematic Observation Scale utilizes single-subject repeated measurements. Symptoms and issues of interest are defined and a variety of frequency and sampling methods can be applied. The Systematic Observation Scale was designed so Primary Observers (parents, guardians, self observers or others) can make pre-treatment and subsequent observations to track, document and evaluate symptom variation over the course of an illness. The measurement utilized is the percentage of time the symptom is observed by the primary observer since the previous observation.|May-7-2008 to July -14-2010||||||
771379|NCT00723580|Primary|Actigraphic Measurement of Treatment Conditions|The child’s impulsivity and inability to sleep represented a significant symptom and risk factor. Impulsivity and sleep will be actigraphically assessed by treatment conditions.|May 12- July 14, 2010|Single subject repeated Actigraphic(at thirty second intervals), observational (every two months) and psychometric (baseline and at 23 months) measurements of a child anticipating pharmacological treatment. Actigraphic measurements (three 21 day periods) over five treatment conditions that included a non-medication baseline and spanned 23 months.||activity|Participants|Standard Deviation|Mean
771380|NCT00723606|Secondary|Change From Baseline in Behavioral Activity Rating Scale (BARS) at 72 Hours|BARS measures the degree of agitated behavior using a 7-point scale describing increasing levels of activity (1 =difficult or unable to rouse; 2 = asleep but responds normally to verbal or physical contact; 3 = drowsy, appears sedated; 4 = quiet and awake [normal level of activity]; 5 = signs of overt [physical or verbal] activity, calms down with instructions; 6 = extremely or continuously active, not requiring restraint; 7 = violent, requires restraint.|Baseline, 72 hours|FAS. Missing data were replaced by LOCF.||scores on a scale||Standard Error|Least Squares Mean
771381|NCT00723606|Secondary|Change From Baseline in Clinical Global Impressions Severity (CGI-S) Score at 72 Hours|CGI-S: 7-point clinician rated scale to assess severity of subject's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Change: score at observation minus score at baseline.|Baseline, 72 hours|FAS. Missing data were replaced by LOCF.||scores on a scale||Standard Error|Least Squares Mean
771382|NCT00723606|Secondary|Clinical Global Impression-Improvement (CGI-I) Score at 72 Hours|CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|72 hours|FAS. Missing data were replaced by LOCF.||scores on a scale||Standard Error|Least Squares Mean
771383|NCT00723606|Secondary|Change From Baseline in BPRS Agitation Subscale Score at 72 Hours|The BPRS agitation subscale score was composed of 4 questions (questions 2, 6, 10, 17). The BPRS agitation subscale score was obtained by summing the relevant individual items. Total possible score range=4 to 28. Change: score at final visit minus score at baseline.|Baseline, 72 hours|FAS. Missing data were replaced by LOCF.||scores on a scale||Standard Error|Least Squares Mean
771384|NCT00723606|Secondary|BPRS Agitation Subscale Response at 72 Hours|The BPRS agitation subscale score was composed of 4 questions (questions 2, 6, 10, 17). The BPRS agitation subscale score was obtained by summing the relevant individual items. Total possible score range=4 to 28. A response was defined as a > 30 percent reduction from baseline in BPRS agitation subscale score.|72 hours|FAS. Missing data were replaced by last observation carried forward (LOCF).||participants|||Number
771385|NCT00723606|Primary|Change From Baseline in Brief Psychiatric Rating Scale (BPRS) Total Scores at 72 Hours|BPRS is an 18-item clinician rated scale with 11 general symptom items, 5 positive-symptom items, and 2 negative symptom items scored on a 7-point scale (1=not present and 7=extremely severe), with higher score indicating greater severity of symptom. Total possible score range=18 to 126. Change: score at final visit minus score at baseline.|Baseline, 72 hours|Per protocol (PP) population = Full Analysis Set (FAS) subjects (ie, randomized subjects who took at least one dose of study medication) who provided a baseline and 72 hour BPRS total score and did not deviate from the protocol in a significant manner.||scores on a scale||Standard Error|Least Squares Mean
771386|NCT00723632|Secondary|Average Cost Per Participant With SVR Stratified by Prior Treatment Status|SVR is defined as undetectable HCV ribonucleic acid (RNA) six months after the end of treatment. Cost per participant with SVR was calculated as a ratio of the total costs for all participants and the number of participants with SVR in the given group. All costs were adjusted for inflation to 2010 values.|From enrollment up to 48 weeks for participants with HCV genotype 1, and from enrollment up to 24 weeks for participants with HCV genotypes 2 and 3|Participants were included in the analysis if all of the following conditions were met: initial exam form was completed; at least 1 follow up visit form was completed; the end of treatment (either according to plan or early) was recorded; and SVR status was recorded six months after treatment termination.||Czech Crown||Full Range|Mean
771387|NCT00723632|Secondary|Average Cost Per Participant With SVR Stratified by Ribavirin Dosage|SVR is defined as undetectable HCV ribonucleic acid (RNA) six months after the end of treatment. Cost per participant with SVR was calculated as a ratio of the total costs for all participants and the number of participants with SVR in the given group. All costs were adjusted for inflation to 2010 values.|From enrollment up to 48 weeks for participants with HCV genotype 1, and from enrollment up to 24 weeks for participants with HCV genotypes 2 and 3|Participants were included in the analysis if all of the following conditions were met: initial exam form was completed; at least 1 follow up visit form was completed; the end of treatment (either according to plan or early) was recorded; and SVR status was recorded six months after treatment termination.||Czech Crown||Full Range|Mean
771388|NCT00723632|Primary|Average Cost Per Participant With Sustained Virologic Response (SVR) Stratified by Weight Category|SVR is defined as undetectable HCV ribonucleic acid (RNA) six months after the end of treatment. Cost per participant with SVR was calculated as a ratio of the total costs for all participants and the number of participants with SVR in the given group. All costs were adjusted for inflation to 2010 values.|From enrollment up to 48 weeks for participants with hepatitis C virus (HCV) genotype 1, and from enrollment up to 24 weeks for participants with HCV genotypes 2 and 3|Participants were included in the analysis if all of the following conditions were met: initial exam form was completed; at least 1 follow up visit form was completed; the end of treatment (either according to plan or early) was recorded; and SVR status was recorded six months after treatment termination.||Czech Crown||Full Range|Mean
771389|NCT00723645|Secondary|Percentage of Participants Who Relapsed After EOT at Week 72 (Late Relapser)|"Late relapse was defined as having a Sustained Viral Response (SVR) at 24 weeks of follow-up and subsequently having a positive viral load 48 weeks later at Week 72.
SVR was defined as negative for HCV RNA at Week 24 of follow-up."|From 24 weeks post-treatment to 72 weeks post-treatment|"The evaluable population consisted of all enrolled participants who were virus negative at the end of treatment and also virus-negative at Week 24 (Visit 2).
187 participants completed Visit 2, 14 participants were excluded from analysis, and 173 participants were evaluable for Week 72 (Visit 3)."||Percentage of participants||95% Confidence Interval|Number
771390|NCT00723645|Primary|Percentage of Participants With Relapse At 24 Weeks After the End Of Treatment (EOT)|"Relapse rate is defined as the percentage of participants with negative viral load (HCV RNA-) at EOT who have positive viral load (HCV RNA+) at 6 months after EOT.
RNA= Ribonucleic Acid"|From enrollment (≤4 weeks after end of treatment) to Week 24 post-treatment|The evaluable population consisted of all enrolled participants who were virus negative at the end of treatment. 249 participants were evaluable for Week 24 (Visit 2).||Percentage of participants||95% Confidence Interval|Number
771391|NCT00723697|Primary|Number of Patients With Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents) as Reported by Physician.|Number of patients with misuse behaviours on physician-questionnaire response at first (D1), 6 month (M6), and 12 month (M12) visits.|first visit, 6 months, and 12 months|All eligible patients||participants|||Number
771392|NCT00723697|Secondary|Number of Patients Reporting Clinical Consequences of Engaging in Misuse|Number of patients with clinical consequences (development or progression of: abscess, nutritional deficiency, dental problems, psychiatric problems including depression, sleep problems, schizophrenia, anxiety, phobias, hallucinations, delirium, withdrawal symptoms, inhibition, suicide attempts and other problems) at first, 6 month, and/or 12 month visit.|first visit, 6 months, and 12 months|Number of patients analyzed for the consequence, at each visit.||participants|||Number
771393|NCT00723697|Primary|Number of Patients Reporting Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents)|Number of patients who indicate misuse behaviours on self-questionnaire response at first (D1), 6 month (M6), and 12 month (M12) visits.|first visit, 6 months, and 12 months|Number of patients with self-questionnaire responses.||participants|||Number
771394|NCT00723710|Primary|Number of Participants Who Completed Treatment|Treatment completion was defined as those who completed both the induction and maintenance phases.|Up to 1 year|The number of participants who started the induction phase||Participants|||Number
771395|NCT00723736|Primary|Proportion of Patients With Adverse Events|An adverse event is any untoward medical occurrence or unfavorable and unintended sign in a subject administered a pharmaceutical product, whether or not considered related to the use of that product. This includes the onset of new illness and the exacerbation of pre-existing conditions.|Follow-up visit at 3 - 5 weeks after treatment initiation|||participants|||Number
771396|NCT00723749|Secondary|Drug Craving (Subjective Effects of Therapy)|Circumstances of switching to SUBOXONE®: Analyse change of drug craving for opiates by using a 100mm visual analog scale (minimum: 0 = no craving; maximum: 100 = high craving)|Baseline and Final Assessment (month 12 or time of dropout)|The analysis cohort included all patients prospectively documented, with informed consent, at least 15 years of age at enrollment with written consentment to treatment of drug dependence, for whom SXN-therapy was indicated and planned and with documentation for at least visit 1, visit 2 and visit 12 (end-of-study or discontinuation documentation).||Units on a scale||Standard Deviation|Mean
771397|NCT00723749|Secondary|Take Home Prescriptions of SUBOXONE®|"Circumstances of switching to SUBOXONE®: Analyze if the number of take home prescriptions of SUBOXONE®, reported by the treating physician, increase between day 1 and the final assessment.
Take Home prescription is defined as a prescription of up to 7 daily dosages SUBOXONE® from the treating physician which allows the patients to receive the prescribed amount of daily dosages SUBOXONE® from a pharmacy to take home and dispense the medication on his own on a daily basis.
A patient can receive only one take home prescription for up to 7 days at the time."|Day 1 and Final Assessment (month 12 or time of dropout)|The analysis cohort included all patients prospectively documented, with informed consent, at least 15 years of age at enrollment with written consentment to treatment of drug dependence, for whom SXN-therapy was indicated and planned and with documentation for at least visit 1, visit 2 and visit 12 (end-of-study or discontinuation documentation).||participants with take home prescription|||Number
771398|NCT00723749|Primary|Retention Rate After 12 Months of Treatment With Suboxone|The primary aim of the SUBOXONE® NIS was to document the 12-month retention rate for at least N = 300 subjects with opioid dependence in a real-life scenario in at least N = 70 sites throughout Germany.|12 months|The analysis cohort included all patients prospectively documented, with informed consent, at least 15 years of age at enrollment with written consentment to treatment of drug dependence, for whom SXN-therapy was indicated and planned and with documentation for at least visit 1, visit 2 and visit 12 (end-of-study or discontinuation documentation).||% of participants||95% Confidence Interval|Number
771399|NCT00723749|Secondary|Dosage of SUBOXONE®|Circumstances of switching to SUBOXONE®: Analyse induction and maintenance dose of SUBOXONE®.|Day 1 and Final Assessment (month 12 or time of dropout)|The analysis cohort included all patients prospectively documented, with informed consent, at least 15 years of age at enrollment with written consentment to treatment of drug dependence, for whom SXN-therapy was indicated and planned and with documentation for at least visit 1, visit 2 and visit 12 (end-of-study or discontinuation documentation).||mg daily dosage of Suboxone||Standard Deviation|Mean
771400|NCT00723788|Primary|Diagnostic Sensitivity/Specificity and Accuracy of Appendiceal MRI Comparedsurgical Findings or Clinical Follow-up|Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV)|during diagnostic procedure|All patients received MRI, of those 20 also received US and 9 CT, meaning that 8 patients received all three procedures.||participants|||Number
771401|NCT00723801|Secondary|Diastolic Function - Ejection Fraction|Two-dimensional echocardiography was performed using a 3.0 MHz transducer (General Electric VIVID 7). Left ventricular and left atrial dimensions were determined in parasternal long axis views. Left ventricular ejection fraction was calculated using the modified Simpsons calculation in the apical two and four chamber views.|Baseline and 6 months|||Change in % ejection fraction||Standard Deviation|Mean
771402|NCT00723801|Primary|Aortic Biophysical Properties - Pulse Wave Velocity|Aortic stiffness was assessed using applanation tonometry (SphygmoCor®, AtCor Medical, West Ryde, NSW, Sydney, Australia) to measure carotid to femoral artery pulse wave velocity (PWV). With the patient lying supine in a quiet environment, a handheld micromanometer-tipped probe was applied to the skin surface over the carotid and femoral arteries, compressing the vessel wall so that transmural forces within the vessel wall were perpendicular to the arterial surface. The distance from the sternal notch to the sites of carotid and femoral pulse acquisition were measured and inputted into the device to represent the relative distance from the carotid to femoral artery. The calculation of distance divided by time of pulse upstroke relative to the upstroke of the QRS on a 3 lead surface EKG was used by the device to calculate velocity. All recorded measurements met the manufacturer’s quality control standards integrated into the software package.|Baseline and 6 months|||change in meters/second||Standard Deviation|Mean
771403|NCT00723827|Primary|Efficacy: Number of Participants Experiencing Complete Response (CR), Partial Response (PR), or Stable Disease(SD)|The response ratings were based on the judgment of the investigator.|Complete study duration (up to approximately 6.5 months)|||participants|||Number
771404|NCT00723827|Primary|Number of Temozolomide Drug Interactions|Drug interaction was defined as a chemical or physiological reaction that can occur when two different drugs are taken together.|Complete study duration & 30 days after completion (up to approximately 7.5 months)|||events|||Number
771405|NCT00723827|Primary|Number of Temozolomide Misuse or Abuse Events|"Drug abuse was defined as the use of the study drug for a non-therapeutic effect.
Misuse was defined as use of the study medication in a way that was not prescribed."|Complete study duration & 30 days after completion (up to approximately 7.5 months)|||Events|||Number
771406|NCT00723827|Primary|Number of Participants Experiencing Unexpected Adverse Drug Reactions (ADRs)|An unexpected ADR was defined as an adverse reaction, whose nature, severity, specificity, or outcome is not consistent with the term or description used in the applicable product information.|Complete study duration & 30 days after completion (up to approximately 7.5 months)|||participants|||Number
771407|NCT00723827|Primary|Number of Participants Experiencing Adverse Events (AEs)|An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of vaccine, whether or not considered related to the medicinal product.|Complete study duration & 30 days after completion (up to approximately 7.5 months)|||participants|||Number
771495|NCT00727506|Secondary|Number of Participants With Clinically Relevant Abnormalities for Decreased Cardiac Left Ventricular Function - Phase II|Number of participants with Clinically Relevant Abnormalities for decreased Cardiac left ventricular function.|From first administration of treatment until 28 days after last drug administration, up to 518 days.|Treated set||Participants|||Number
771408|NCT00723840|Primary|EuroQoL (Quality of Life)-5 Dimensions (EQ-5D) Scores in Participants With Crohn's Disease|"EQ-5D was calculated for the pharmacoeconomics analysis to evaluate quality of life (QoL) in participants in the active phase with Crohn's Disease and had a CDAI score >= 150.
EQ-5D is a participant answered questionnaire scoring 5 dimensions - mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ-5D total score ranges from 0 (worst health state) to 1 (perfect health state) and 1 reflects the best outcome."|Baseline, 6, 12, and 18 months|Of the enrolled population, a total of 82 subjects interrupted the study prematurely. For one participant, the age and sex were not available. These participants were not included in the pharmacoeconomic analysis.||Score on a scale|||Number
771409|NCT00723840|Primary|Cost of Illness in Participants With Crohn's Disease|"Direct health care costs, non health care costs and costs for productivity loss were calculated by observation period in Crohn's Disease participants (in active phase) with a CDAI score >= 150.
Direct health care costs refer to the resources used to prevent and treat a disease. Indirect costs include expenses for a participant's (or their caregiver's) transport, home assistance or home nursing assistance. Costs for productivity loss include the participant's (or their caregiver's) productivity loss or time loss."|Baseline, 6, 12, and 18 months|Of the enrolled population, a total of 82 subjects interrupted the study prematurely. For one participant, the age and sex were not available. These participants were not included in the pharmacoeconomic analysis.||Euros|||Number
771410|NCT00723892|Secondary|the Average Length of Treatment for Participants on Treatment for Hepatitis C With PegIntron Pen/Rebetol||12 months after onset of treatment|Participants with no missing results.||Weeks||Standard Deviation|Mean
771411|NCT00723892|Primary|Number of Participants Who Complete Treatment With PegIntron/Rebetol Therapy for Hepatitis C When Administered With a Patient Psychotherapy Support Program as Compared to a Group Without a Psychotherapy Support Program.||12 months after onset of treatment|Participants foreseen to complete treatment, consulted and assigned to treatment were analyzed.||Participants|||Number
771412|NCT00723931|Primary|Number of Participants That Reported a Non Serious Adverse Event Above 5 Percent Threshold|Adverse events (AE's) were events that resulted in unintended signs, symptoms or illnesses. All non-serious adverse events related or unrelated to the study drug and those AE's determined by the investigator, using specific criteria defined in the protocol, were reported.|24 weeks after administration of PegIntron Injection.|||Participants|||Number
771413|NCT00723931|Primary|Number of Participants That Reported a Serious Adverse Event|Serious adverse events (SAE's) were events that resulted in death, were life threatening, required hospitalization, caused disability, and congenital anomaly. All SAE's related or unrelated to the study drug and those SAE's that were determined by the investigator, using specific criteria defined in the protocol, were reported.|24 weeks after administration of PegIntron Injection|||Participants|||Number
771414|NCT00723944|Secondary|Osseous Integration||4 years||||||
771415|NCT00723944|Primary|Crestal Bone Regression (Amount of Bone Measured) Around Each Implant Unit|Millimeters of crestal bone observed and measured in a radiograph of each study implant is measured and averaged to obtain the mean crestal bone loss or gain for each implant unit.|1 year|population represents all patients receiving test and control implants enrolled in the study, but only those implants achieving integration (lack of mobility) were analyzed and reported here up to the 12 months follow-up stage.||millimeters|implants|Standard Error|Mean
771416|NCT00723957|Secondary|Median Length of Survival in the Overall Population and in the Subgroups of Patients With βIII-tubulin Positive (β3T+) and βIII-tubulin Negative (β3T-)Tumors|Overall Survival was computed for all randomized participants and was defined as the time between randomization and death. Participants who did not die at the end of the study were censored at their last known alive date.|Randomization to death or last known alive date, up to 31.34 months|All participants randomized to receive treatment||Months||95% Confidence Interval|Median
771417|NCT00723957|Secondary|Number of Participants With Grade 3 or 4 Abnormalities in Liver Function and Urine Laboratory Test Results|ULN=upper level of normal. Alkaline phosphatase (ALP) Gr 1:>ULN to 2.5*ULN, Gr 2: >2.5 to 5.0*ULN, Gr 3: >5.0 to 20.0*ULN, Gr 4: >20.0*ULN; Aspartate aminotransferase (AST) Gr 1: >ULN to 2.5*ULN, Gr 2: >2.5 to 5.0*ULN, Gr 3: >5.0 to 20.0*ULN, Gr 4: >20.0*ULN|At screening and within 72 hours of start of 21-day cycle (Cycle 2 and beyond)|All participants who received any investigational product.||Participants|||Number
771418|NCT00723957|Secondary|Number of Participants With Hematology Laboratory Results of Grade 3 or 4|LLN=lower level of normal. Leukocytes (leukopenia) Grade 1: <LLN to 3.0*10^9/L, Grade 2:<3.0 to 2.0*10^9/L, Grade 3: <2.0 to 1.0*10^9/L, Grade 4: <1.0*10^9/L; Neutrophils (neutropenia) Grade 1: <LLN to 1.5*10^9/L, Grade 2: <1.5 to 1.0*10^9/L, Grade 3: <1.0 to 0.5*10^9/L, Grade 4: <0.5*10^9/L; Platelet count(thrombocytopenia) Grade 1: LLN to 75.0*10^9/L, Grade 2: <75.0 to 50.0*10^9/L, Grade 3: <50.0 to 25.0*10^9/L, Grade 4:<25.0 to 10^9/L; Hemoglobin (anemia) Grade 1: <LLN to 10.0 g/dL, Grade 2: <10.0 to 8.0 g/dL, Grade 3: <8.0 to 6.5 g/dL, Grade 4: <6.5 g/dL.|At screening and weekly during 21-day cycle|All participants who received any investigational product.||Participants|||Number
771419|NCT00723957|Secondary|Number of Participants With Death as Outcome, Drug-related Adverse Events (AEs), Serious AEs (SAEs), Drug-related SAEs, AEs Leading to Discontinuation, and Drug-related Peripheral Neuropathy|An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related is defined as possibly, probably, or certainly related to and of unknown relationship to study treatment.|Days 1 through 21, continuously|All participants who received any investigational product.||Participants|||Number
771420|NCT00723957|Secondary|Time to Response|Time to Response is defined as the time from randomization date until the date of first response (Partial Response [PR] or Complete Response [CR])|Randomization to date of first response (PR or CR)|All randomized participants||Weeks||Full Range|Median
771496|NCT00727506|Secondary|Causes of Death - Phase II|Causes of death during on treatment.|From first administration of treatment until 28 days after last drug administration, up to 518 days.|Treated set||deaths|||Number
771513|NCT00727506|Secondary|Phase II - Trough Plasma Concentration of Afatinib|Trough plasma concentration of afatinib after multiple administration of 40 mg afatinib administered as monotherapy or in combination with 75 mg/m² temozolomide|Before (-0.05 h) the drug administration of afatinib on Day 15 of Cycle 2 & 3|PKS||ng/mL||Geometric Coefficient of Variation|Geometric Mean
771421|NCT00723957|Secondary|Percentage of Participants With Best Response of Complete Response (CR) or Partial Response (PR)|Response evaluated per Response Evaluaton in Solid Tumor (V1.0) guidelines and assessed using magnetic resonance imaging. Percentage of best response=the total number of participants with the best overall response of CR or PR divided by the total number of randomized participants in that treatment arm. CR=disappearance of all target lesions; PR=at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|At randomization and then every 6 weeks to date of CR, PR, or progression for 6 21-day cycles|||Percentage of participants||95% Confidence Interval|Mean
771422|NCT00723957|Secondary|Progression-free Survival in the Overall Population|Progression-free survival is defined as the period from date of randomization to date of disease progression or death. For participants who do not progress or die at the end of the study, progression-free survival was censored at the last tumor assessment date. For those who have no on study tumor assessment, progression-free survival was censored at the date of randomization.|Randomization to disease progression or death, assessed to 12.29 months|All randomized participants who received study drug||Months||95% Confidence Interval|Median
771423|NCT00723957|Secondary|Progression-free Survival in the Subgroup of Participants With βIII-tubulin Negative Tumors|Progression-free survival is defined as the period from date of randomization to date of disease progression or death. For participants who do not progress or die at the end of the study, progression-free survival was censored at the last tumor assessment date. For those who have no on study tumor assessment, progression-free survival was censored at the date of randomization.|Randomization to disease progression or death (maximum reached: 12.29 months)|All randomized participants who had βIII-tubulin positive tumors and who received study drug||Months||95% Confidence Interval|Median
771424|NCT00723957|Primary|Progression-free Survival in the Subgroup of Participants With βIII-tubulin Positive Tumors|Progression-free survival is defined as the period from date of randomization to date of disease progression or death. For participants who do not progress or die at the end of the study, progression-free survival was censored at the last tumor assessment date. For those who have no on-study tumor assessment, progression-free survival was censored at the date of randomization. A tumor was considered to be beta III (βIII)-tubulin positive if 50% or more of the tumor cells had a βIII-tubulin immunohistochemistry staining intensity equal to or greater than that of the positive control.|Randomization to disease progression or death (maximum reached: 14.39 months )|All randomized participants with βIII-tubulin positive tumors and who received study drug||Months||95% Confidence Interval|Median
771425|NCT00724009|Secondary|Leukemia Free Survival|Time to event analysis used the day of transplant as day 0.|2 years|One patient with refractory AML underwent conditioning but died 1 day before stem cell infusion due to sepsis (grade 5 infection)||days||95% Confidence Interval|Median
771426|NCT00724009|Secondary|Number of Participants Infection Adverse Events|Treatment-related toxicity was calculated according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|Day 12|||participants|||Number
771427|NCT00724009|Secondary|Number of Participants With Skin Adverse Events|Treatment-related toxicity was calculated according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|Day 12|||participants|||Number
771428|NCT00724009|Secondary|Number of Participants With Cardiac Adverse Events|Treatment-related toxicity was calculated according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|Day 12|||participants|||Number
771429|NCT00724009|Secondary|Number of Participants With Hepatic (SGOT) Adverse Events|Treatment-related toxicity was calculated according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|Day 12|||participants|||Number
771430|NCT00724009|Secondary|Number of Participants With Hepatic (Total Bilirubin) Adverse Events|Treatment-related toxicity was calculated according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|Day 12|||participants|||Number
771431|NCT00724009|Secondary|Number of Participants With Renal Adverse Events|Treatment-related toxicity was calculated according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|Day 12|||participants|||Number
771432|NCT00724009|Primary|Cytoreductive Response|Percent of patients achieving cytoreductive response of marrow cellularity <20% and blasts < 10%|Day 12|||percentage of participants|||Number
771433|NCT00724061|Other Pre-specified|Correlation of Response With Infiltration of Skin Lesions With Dendritic Cells, Cytotoxic CD8+ T-cells, and NK-cells||Baseline, 24 hours post-1st dose in the dose escalation phase, and 24 hours post-1st dose in the maintenance therapy phase||||||
771434|NCT00724061|Other Pre-specified|Change in Activation Status of Key Signaling Molecules Between Baseline and After 2 Weeks of Treatment|The activation status of key signaling molecules affecting the PI3K and JAK/STAT pathways was to be analyzed in samples of skin and blood taken at baseline and after 2 weeks of treatment. Participation in this exploratory component of the trial was optional for patients.|At baseline and after 2 weeks of treatment (for those patients who consented to this portion)||||||
771435|NCT00724061|Secondary|To Evaluate the Duration of Response|To evaluate duration of response related to combined pegylated IFN-α-2b plus PUVA or NB-UVB therapy.|At each study visit||||||
771436|NCT00724061|Secondary|Number of Patients Exhibiting a Complete Response|"Response was assessed according to the Composite Assessment of Index Lesion Disease Severity. Clinical signs are graded on scales of 0 to 8 (0 being no evidence of disease and 8 being the near worst severity of sign/symptom). The CA response is calculated as the ratio of the sum of the grades for all clinical signs plus the surface areas for all index lesions at each visit compared to the sum of these grades at baseline. The CA also considers all other cutaneous lesions and any extra-cutaneous manifestations of disease.
CR requires a CA ratio of 0 (zero) with no evidence of new disease (abnormal or pathologically positive lymph nodes, cutaneous or other tumor manifestations, visceral disease) present over 4 weeks. Patients with Sézary Syndrome must have no evidence of circulating Sézary cells (< 5% Sézary cells are considered to be not significant). Skin biopsy is required for documentation of CR."|From the date the first patient begins treatement until the last patient achieves complete response (response was assessed every 4 weeks)||||||
771437|NCT00724061|Primary|Change in Total Health-related Quality of Life Score Using the Functional Assessment of Cancer Therapy – Biologic Response Modifier (FACT-BRM)|The FACT-BRM is a patient self-report tool to assess health-related quality of life measures.|From the date that the first patient was registerd until the last patient came off treatment (score assessed at baseline, every 2 weeks during dose escalation, and then monthly during maintenance therapy for each patient)||||||
771438|NCT00724061|Primary|Number of Dose Limiting Toxicities (DLTs) Observed During Dose Escalation of PEG-IFN-α-2b|"Adverse events are graded according to the National Cancer Institute's Common Toxicity Criteria (CTCAE) version 3.0. In general, grades are assigned as follows:
Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE
A dose limiting toxicity (DLT) will be defined as any grade 3 or higher hematologic toxicity or any grade 4 non-hematologic toxicity."|From the date that the first patient began treatment until the last patient completed the dose escalation phase (up to 12 weeks per patient)|||dose limiting toxicities|||Number
771439|NCT00724126|Secondary|Proportion of Subjects Who Had Adequate Relief of IBS-related Bloating for at Least 2 of the 4 Weeks During the Primary Evaluation Period (ie, Weeks 3 Through 6)|"The secondary outcome measure is assessed during the 4-week period (ie, Weeks 3 through 6) immediately following 2 weeks of treatment with study drug.
Adequate relief of bloating was defined as a response of yes to the following question, which was asked weekly (every 7 days): In regard to your symptom of bloating, as compared to the way you felt before you started study medication, have you, in the past 7 days, had adequate relief of your IBS symptom of bloating? [Yes/No]."|4 weeks|The analysis population was the intent-to-treat population, defined as subjects who received at least 1 dose of study drug. Two randomized subjects (1 in each group) did not receive study drug and were not included in the intent-to-treat population.||percentage of responders|||Number
771440|NCT00724126|Primary|Proportion of Subjects Who Had Adequate Relief of Global IBS Symptoms for at Least 2 of the 4 Weeks During the Primary Evaluation Period (ie, Weeks 3 Through 6).|"The primary outcome measure is assessed during the 4-week period (ie, Weeks 3 through 6) immediately following 2 weeks of treatment with study drug.
Adequate relief of global IBS symptoms was defined as a response of yes to the following question, which was asked weekly (every 7 days): In regard to all your symptoms of IBS, as compared to the way you felt before you started study medication, have you, in the past 7 days, had adequate relief of your IBS symptoms? [Yes/No]"|4 weeks|The analysis population was the intent-to-treat population, defined as subjects who received at least 1 dose of study drug. Two randomized subjects (1 in each group) did not receive study drug and were not included in the intent-to-treat population.||percentage of responders|||Number
771441|NCT00724152|Secondary|Tinnitus Reaction Questionnaire (TRQ)|This is another commonly used measure of tinnitus distress in research. The TRQ is a global measure of tinnitus distress and was developed using correlations with clinician and self-report ratings of symptom categories. Scores on this measure range from 0 to 104 with higher scores indicating more distress. This measure has a high internal consistency reliability (Cronbach’s alpha = .96) and test-retest validity for the total score (r = .88). Scores of 17 points or higher on this measure will indicate tinnitus severity is such that the patient is significantly disturbed by tinnitus. This is based on the use of the TRQ as a pre-test measure in measuring outcome of a controlled trial of CBT for tinnitus in an elderly sample. That study sample had an average TRQ score of 16.9 prior to treatment.|pre-treatment (session 1) to post-treatment (session 6; approximately 6 weeks later)|Period 1 and Period 2||units on a scale ranging 0-104||Standard Deviation|Mean
771442|NCT00724152|Primary|Tinnitus Handicap Inventory (THI)|Most widely used measure of tinnitus distress available during study period. The THI was created using the Tinnitus Handicap Questionnaire and the Tinnitus Questionnaire as well as the Beck Depression Inventory and Modified Somatic Perception Questionnaire. Its construct validity was also assessed using patients’ responses on symptom rating scales and auditory tests of pitch and loudness. The THI score ranges from 0 to 100, with 100 indicating the most severe tinnitus and 0 is the least severe tinnitus. The authors of the THI have designated levels of severity, with scores of 16 and below falling into the “no handicap” range. This measure has strong internal consistency reliability (Cronbach’s alpha = .93) and test-retest validity for the total score (r = .92). Significant improvement in tinnitus handicap can be observed with a 20-point change in total score.|pre-treatment (session 1) to post-treatment (session 6; approximately 6 weeks after session 1)|Period 1 and Period 2||units on a scale of 0-100||Standard Deviation|Mean
771443|NCT00718510|Secondary|Change From Baseline in Mean Calgary Depression Scale for Schizophrenia (CDSS) at 3 Weeks|The Secondary Outcome Measure was the Calgary Depression Scale for Schizophenia (CDSS). The CDSS is a 9-item scale that is used to rate the depressive symptoms in patients with schizophrenia. For each CDSS item, symptom severity was rated on a 3-point scale, from 0=absent to 3=severe. The CDSS total score ranges from 0 to 27 with a higher score indicating a greater severity of symptoms.|Baseline and 3 Weeks|||units on a scale||Standard Deviation|Mean
771444|NCT00718510|Secondary|Change From Baseline in Mean Clinical Global Impression (CGI) Scale at 3 Weeks|The Secondary Outcome Measure was the Clinical Global Impression (CGI) scale. The CGI is a 3-item scale that rates treatment response and monitors the clinical course of all psychiatric illnesses including schizophrenia. Within the CGI, the Severity of Illness was rated on a 7-point scale, 0=not assessed to 7=among the most severely ill patients. For Global Improvement, the total improvement following treatment as compared to at baseline of the trial was rated on a 7-point scale, 0=not assessed to 7=very much worse.|Baseline and 3 Weeks|All participants who received all doses of each intervention and completed all study visits were included in the efficacy analysis||units on a scale||Standard Deviation|Mean
771445|NCT00718510|Primary|Change From Baseline in Mean Positive and Negative Syndrome Scale (PANSS) Total and Positive, Negative and General Psychopathology Subscale Scores at 3 Weeks|The primary outcome measure was the Positive and Negative Syndrome Scale (PANSS) total score and PANSS positive, negative and general psychopathology subscale scores. The PANSS is a 30-item scale used to evaluate the symptoms of schizophrenia. For each PANSS item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score (30 items) ranges from 30 to 210 with a higher score indicating a greater severity of symptoms. The PANSS positive symptom subscale score (7 items) ranges from 7=absent to 49=extreme; the PANSS negative subscale score (7 items) ranges from 7=absent to 49=extreme; and the PANSS general psychopathology subscare score (16 items) ranges from 16=absent to 112=extreme.|Baseline and 3 Weeks|All participants who received all doses of each intervention and completed all study visits were included in the efficacy analysis||units on a scale||Standard Deviation|Mean
771446|NCT00718523|Secondary|Overall Survival (OS)|Interval between the date from randomization to death from any cause whichever came first.|Day 1 of each cycle up to 4 years after randomization|Unstratified Intent To Treat||months||95% Confidence Interval|Median
771548|NCT00727636|Primary|Antibody Titer to HPV 6||Month 7|||milli-Merck units/mL||95% Confidence Interval|Geometric Mean
771447|NCT00718523|Secondary|Time To Progression (TTP): Interval From the Date of Randomization to the Date of Disease Progression|"A patient may have been declared to have progressive disease on the basis of radiological measuremt of tumor lesions assessmt or CA125 evaluation (tumor measuremts taking precedence).Radiological progression was defined as per the RECIST guidelines (Therasse et al, JNCI2000) as at least 20% increase in the sum of the longest diameters of target lesions(ref the smallest sum of the longest diam recorded since the treatmt started or since the appearance of at least 1 new lesion).Serum CA125 progression was defined, according to the 2005 GCIG def: pts with:
Elevated CA125 pretreatmt and normalization of CA125 has to show evidence of CA125≥ 2 times the upper normal limit on 2 occasions at least 1 wk apart OR
Elevated CA125 pretreatmt which never normalized must show evidence of CA125≥ 2 times the nadir value on 2 occasions at least 1 wk apart OR
CA125 in the normal range pretreatmt had to show evidence of CA125 ≥ 2 times the upper normal limit on 2 occasions at least 1 wk apart"|Radiological tumor assessment: every 12 (+/- 1) weeks for 3 years after randomization + CA125: day 1 of each cycle|Unstratified Intent To Treat||months||95% Confidence Interval|Median
771448|NCT00718523|Primary|Progression Free Survival (PFS): Time From Randomization Until Date of Progression or Death.|"A patient may have been declared to have progressive disease on the basis of radiological measuremt of tumor lesions assessmt or CA125 evaluation (tumor measuremts taking precedence).Radiological progression was defined as per the RECIST guidelines (Therasse et al, JNCI2000) as at least 20% increase in the sum of the longest diameters of target lesions(ref the smallest sum of the longest diam recorded since the treatmt started or since the appearance of at least 1 new lesion).Serum CA125 progression was defined, according to the 2005 GCIG def: pts with:
Elevated CA125 pretreatmt and normalization of CA125 has to show evidence of CA125≥ 2 times the upper normal limit on 2 occasions at least 1 wk apart OR
Elevated CA125 pretreatmt which never normalized must show evidence of CA125≥ 2 times the nadir value on 2 occasions at least 1 wk apart OR
CA125 in the normal range pretreatmt had to show evidence of CA125 ≥ 2 times the upper normal limit on 2 occasions at least 1 wk apart"|Radiological tumor assessment: every 12(+/- 1) weeks for 3 years after randomization + CA 125: day 1 of each cycle|Unstratified Intent To Treat||months||95% Confidence Interval|Median
771449|NCT00718640|Secondary|Renal Function|Renal function was analysed by creatinine clearance. Creatinine clearance was calculated by Cockroft-Gault fourmula. Creatinine clearance is equal to 140 minus age multiplied by weight and constant (1 for men and 0.85 for women) divided by creatinine in (micro mole per liter)|Day 1 of Cycle 1, 2, 3, 4, 5, 5, 6, 7, 8 and Final/Early termination visit (30-45 days after last dose)|The study was terminated. Due to insufficient number of participants, the outcome measure data was not analyzed.|||||
771450|NCT00718640|Secondary|Quality of Life Assessed by Euro Quality of Life (EQ-5D)|The EQ-5D is a participant rated questionnaire to assess health-related quality of life in terms of a single utility score. It assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression where 1=better health state (no problems), 3=worst health state. Scoring formula was developed by Euro quality of life group which assigns a utility value for each domain in profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Quality of Life (EQ-5D) Final Visit/Early termination visit (30-45 days after last dose)|The study was terminated. Due to insufficient number of participants, the outcome measure data was not analyzed.|||||
771451|NCT00718640|Secondary|Quality of Life Assessment by QLQ C-30|The quality of life was assessed by the questionnaire QLQ C-30 designed by European Organization for the Research and Treatment of Cancer (EORTC). The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer participants. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the fatigue scale is equal to higher level of symptomatology or problems.|Final Visit/Early termination visit (30-45 days after last dose)|The study was terminated. Due to insufficient number of participants, the outcome measure data was not analyzed.|||||
771452|NCT00718640|Secondary|Karnofsky Performance Status (KPS) Score|The KPS is used to quantify participant’s general well-being and activities of daily life and participants are classified based on their functional impairment. KPS score is 11-level score which ranges between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks.|Day 1 of Cycle 1, 3, 5, 7 and Final visit (30-45 days after last dose) or early termination visit|The study was terminated. Due to insufficient number of participants, the outcome measure data was not analyzed.|||||
771453|NCT00718640|Secondary|Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score|The ECOG PS Score 0 versus 1, wherein 0 signifies fully active, able to carry all pre-disease performance without restriction and 1 signifies restriction in physically strenuous activity but ambulatory (able to walk) and able to carry out work on a light or sedentary nature.|Day 1 of Cycle 1, 3, 5, 7 and Final visit/Early termination visit (30-45 days after last dose)|The study was terminated. Due to insufficient number of participants, the outcome measure data was not analyzed.|||||
771454|NCT00718640|Secondary|Duration of Response|The duration of Response was defined as the time of first recorded achievement of a particular response level, which was defined according to IMWG uniform response criteria, as either complete response, stringent complete response, very good partial response or partial response included only responding participants, until the participants were assessed to have progressive disease.|Day 1 (Start of treatment) until the date of first documented achievement of response|The study was terminated. Due to insufficient number of participants, the outcome measure data was not analyzed.|||||
771455|NCT00718640|Secondary|Time to Progression (TTP) of Disease|The TTP was defined as the time from the date of starting treatment until the date of first documented evidence of progression of disease or death.|Day 1 (Start of treatment) until the date of first documented evidence of progression of disease or death|The study was terminated. Due to insufficient number of participants, the outcome measure data was not analyzed.|||||
771479|NCT00724464|Primary|Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up|Sustained virological response (SVR) was assessed at the 24-week post-treatment follow-up (Visit 2). SVR was defined as undetectable plasma Hepatitis C virus Ribonucleic acid (HCV-RNA) at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration).|24 weeks following completion of 24 or 48 weeks of therapy|Efficacy Analysis Set (EAS) included all participants enrolled into the study who attended the final study visit and had HCV RNA evaluation measurement available at the 24-week post-treatment follow-up.||Participants|||Number
771456|NCT00718640|Secondary|Best Response to Treatment|It was assessed by IMWG criteria. It defines complete response as negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow. Very good partial response as serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or > reduction in serum and urine M-protein level<100 mg per 24 hour. Partial Response as <=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by <=90% or to <200mg per 24 hr.|Day 1 of Cycle 1, 2, 3, 4, 5, 5, 6, 7, 8 and Final/Early termination visit (30-45 days after last dose)|The study was terminated. Due to insufficient number of participants, the outcome measure data was not analyzed.|||||
771457|NCT00718640|Primary|Percentage of Participants With Renal Compromised Multiple Myeloma by International Myeloma Working Group (IMWG) Uniform Response Criteria|The IMWG uniform response criteria define; Complete response(CR) as negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow(BM). Stringent CR as CR+normal free light chain ratio and absence of clonal cells in BM Very good partial response (PR) as serum and urine M-protein (monoclonal paraprotein) detectable by immunofixation but not on electrophoresis or 90% or >reduction in serum and urine M-protein level <100 milligram(mg) per 24 hour(hr).PR as <=50% reduction of serum and <= 90% of urine M-protein or up to <200 mg/24 hr.|Week 24 or Early termination visit (30-45 days after last dose)|The study was terminated. Due to insufficient number of participants, the outcome measure data was not analyzed.|||||
771458|NCT00724243|Primary|Number of Participants Fulfilling Criteria for a Therapeutic Response According to the European League Against Rheumatism (EULAR) Response Criteria|Response to treatment was assessed by EULAR response criteria. According to these criteria, participants were characterized as good, moderate, or non-responders based on both DAS level attained and change in DAS. Good response was defined as >1.2 improvement in DAS from Baseline and DAS attained during follow-up of ≤2.4. Non-responders were participants with improvement of ≤0.6 or participants with improvement of >0.6 but ≤1.2 and DAS attained during follow-up of >3.7. Remaining participants were classified as moderate. Scores of good and moderate were considered to have therapeutic response.|Week 14 and Week 54|||Participants|||Number
771459|NCT00724243|Primary|Average Change in Disease Activity Score 28 (DAS 28) From the Beginning of the Treatment|The DAS 28 is an assessment of disease activity based on swollen joint count, erythrocyte sedimentation rate, and general health. Participants can be scored on a range of 0 to 10, with lower scores indicating less disease activity.|Baseline, Week 14, and Week 54|"Thirty-three participants had a DAS 28 score at the beginning of treatment.
Twenty-eight participants had a DAS 28 score at Week 14.
Twenty-two participants had a DAS 28 score at Week 54."||Units on a Scale||Standard Deviation|Mean
771460|NCT00724282|Primary|Plasma Glucose Level at the 120-minute Time Point of a 75g Oral Glucose Tolerance Test||at the end of each treatment|Investigator left university without analyzing data and no information is available on unblinding.|||||
771461|NCT00724308|Secondary|VA Site-level Performance Rates on the VA Tobacco Performance Measures||Quarterly after study implementation||||||
771462|NCT00724308|Secondary|Rate of Use of Smoking Cessation Medications (i.e., Treatment Rate)||2 and 6 months after enrollment||||||
771463|NCT00724308|Secondary|Quit Attempt Rate||2 and 6 months after enrollment||||||
771464|NCT00724308|Secondary|30-day Point Prevalence Abstinence Rate at 2-months (i.e., End of Treatment)||2 months after enrollment||||||
771465|NCT00724308|Primary|Long-term Smoking Abstinence (30-day Point Prevalence Abstinence)||6 months after enrollment|||participants|||Number
771466|NCT00724347|Primary|.Speech Discrimination Ability|Mean consonant identification threshold improvement measure in z-scores (re normal hearing subjects) on consonant and sentence discrimination tests. Additional computerized tests measured auditory short-term verbal memory, and auditory pattern discrimination. The results were compared with baseline performance in the listener group as well as performance in other older hearing impaired subjects who used hearing aids, but who did not undergo training. In the next month, we will published two manuscripts in PLoS ONE describing (1) the benefits of hearing aids on speech comprehension in the absence of perceptual training; (2) the additional benefits of perceptual training. More metholdological details can be found in those manuscripts.|Subjects will receive two months of PC training and be tested before and after 2-months of training with speech tests in the laboratory..|older hearing impaired listeners with hearing aids.||signal to noise ratio in dB SNR||Standard Deviation|Mean
771467|NCT00724373|Primary|Participants With Treatment Success|Identify subgroups of genotype 1 participants to better understand factors affecting response rates & treatment outcomes & to provide predictive models of refractory or responsive phenotypes to aid in HCV treatment, management, & drug development. Treatment success is defined as those who had achieved sustained virological response (i.e. undetectable viraemia 24 weeks post therapy completion).|Data will be collected from the start of first exposure to pegylated interferon alfa-2b and ribavirin combination therapy. Participants who have successfully completed treatment will have data collected for a follow-up period of at least 24 weeks.|Number of participants who had treatment success.||Participants|||Number
771468|NCT00724451|Secondary|Number of Participants With Treatment Failure by Reason for Failure|Investigators recorded reasons for treatment failure whether or not treatment was completed.|24 to 48 weeks|132 of the 500 treated participants failed treatment per Investigator assessment.||participants|||Number
771469|NCT00724451|Secondary|Number of Participants Discontinued From Treatment by Reason for Discontinuation|Investigators recorded reasons for treatment discontinuation.|24 weeks after the end of treatment (total of 48 to 72 weeks)|Reasons for treatment discontinuations were recorded by Investigators for 174 of the 500 treated participants.||participants|||Number
771470|NCT00724451|Primary|Number of Participants Not Eligible for Antiviral Treatment by Reason for Non-eligibility|Investigators recorded their reasons for not prescribing anti-viral treatment. More than one reason leading to non-eligibility could be presented for the same participant.|Measured at baseline|431 of the 1118 participants were determined to be non-eligible for antiviral therapy by Investigator decision.||participants|||Number
771494|NCT00727402|Primary|Cumulative Incidence of Corneal Inflammatory Events|Unadjusted cumulative incidence of corneal inflammatory events (CIE)using survival analysis methods. CIE are corneal infiltrates found in an otherwise clear cornea.|annual|||annual incidence per 100 subjects|Participants|95% Confidence Interval|Mean
779134|NCT00787267|Secondary|Describe Change in Serum Levels of C-terminal Cross-linked Collagen I Between Pre-treatment and 6 Weeks After Starting Dasatinib.||2 years|Assays were not run because no objective tumor response was observed.|||||
771471|NCT00724464|Secondary|Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on Compliance With the 80/80/80 Rule|SVR was assessed by subgroups based on compliance with the 80/80/80 rule where data was available. 80/80/80 compliant participants were those that received >= 80% of the planned total doses of both pegylated interferon alfa-2b & ribavirin for >=80% of the duration of therapy. 3 rates were to be computed: Compliance with study duration, compliance with pegylated interferon dose, & compliance with ribavirin dose. A participant was defined as compliant, if none of the 3 rates were < than 80%. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment.|24 weeks following completion of 24 or 48 weeks of therapy|No data had been captured in the Case Report Forms, and therefore no relevant analysis had been performed.|||||
771472|NCT00724464|Secondary|Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on Achievement of Rapid Virological Response|SVR was assessed at the 24-week post-treatment follow-up (Visit 2) by subgroups based on achievement of rapid virological response (RVR) where data was available. RVR was defined as negative HCV-RNA after 4 (+/- 1) weeks of treatment. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration).|24 weeks following completion of 24 or 48 weeks of therapy|Efficacy Analysis Set (N=309) included all participants enrolled into the study who attended the final study visit and had HCV RNA evaluation measurement available at the 24-week post-treatment follow-up. Of the 309 participants in this population, 286 achieved SVR and were included in this analysis. There was missing data for 250 participants.||Participants|||Number
771473|NCT00724464|Secondary|Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on Study Treatment Dosage Modification|SVR was assessed at the 24-week post-treatment follow-up (Visit 2) by subgroups based on study treatment dosage modification: no dosage modification or any dosage modification of study treatment. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration).|24 weeks following completion of 24 or 48 weeks of therapy|Efficacy Analysis Set (N=309) included all participants enrolled into the study who attended the final study visit and had HCV RNA evaluation measurement available at the 24-week post-treatment follow-up. Of the 309 participants in this population, 286 achieved SVR and were included in this analysis.||Participants|||Number
771474|NCT00724464|Secondary|Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on Alanine Aminotransferase (ALT) Levels at Baseline|SVR was assessed at the 24-week post-treatment follow-up (Visit 2) by subgroups based on ALT levels at baseline as assessed by investigator. Normal baseline ALT level was defined as <40 IU/mL and elevated baseline ALT level was defined as >= 40 IU/mL. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration).|24 weeks following completion of 24 or 48 weeks of therapy|Efficacy Analysis Set (N=309) included all participants enrolled into the study who attended the final study visit and had HCV RNA evaluation measurement available at the 24-week post-treatment follow-up. Of the 309 participants in this population, 286 achieved SVR and were included in this analysis. There was missing data for 6 participants.||Participants|||Number
771475|NCT00724464|Secondary|Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on HCV-RNA Viral Load at Baseline|SVR was assessed at the 24-week post-treatment follow-up (Visit 2) by subgroups based on HCV-RNA viral load at baseline as assessed by investigator. Low viral load was defined as <400,000 International Units/milliliter (IU/mL) and high viral load was defined as >=400,000 IU/mL. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration).|24 weeks following completion of 24 or 48 weeks of therapy|Efficacy Analysis Set (N=309) included all participants enrolled into the study who attended the final study visit and had HCV RNA evaluation measurement available at the 24-week post-treatment follow-up. Of the 309 participants in this population, 286 achieved SVR and were included in this analysis. There was missing data for 32 participants.||Participants|||Number
771476|NCT00724464|Secondary|Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on Liver Fibrosis Stage at Baseline|SVR was assessed at the 24-week post-treatment follow-up (Visit 2) by subgroups based on liver fibrosis stage, where biopsy was available, at baseline: absence, minimal, moderate, or significant as assessed by investigator. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration).|24 weeks following completion of 24 or 48 weeks of therapy|Efficacy Analysis Set (N=309) included all participants enrolled into the study who attended the final study visit and had HCV RNA evaluation measurement available at the 24-week post-treatment follow-up. Of the 309 participants in this population, 286 achieved SVR and were included in this analysis. There was missing data for 157 participants.||Participants|||Number
771477|NCT00724464|Primary|Number of Participants Who Demonstrated Virological Relapse as Assessed at 24-week Post-treatment Follow-up|Virological relapse was assessed at the 24-week post-treatment follow-up (Visit 2). Virological relapse was defined as undetectable plasma HCV-RNA at end of combination treatment (Visit 1- considered Week 24 or Week 48 after treatment start depending on treatment duration), but with positive HCV-RNA at the 24-week post treatment follow-up.|24 weeks following completion of 24 or 48 weeks of therapy|Efficacy Analysis Set (EAS) included all participants enrolled into the study who attended the final study visit and had HCV RNA evaluation measurement available at the 24-week post-treatment follow-up.||Participants|||Number
771478|NCT00724464|Secondary|Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on HCV Genotype at Baseline|SVR was assessed at the 24-week post-treatment follow-up (Visit 2) by subgroups based on HCV genotype (1, 2, 3, 4, or 2 & 3) at baseline. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration).|24 weeks following completion of 24 or 48 weeks of therapy|Efficacy Analysis Set (N=309) included all participants enrolled into the study who attended the final study visit and had HCV RNA evaluation measurement available at the 24-week post-treatment follow-up. Of the 309 participants in this population, 286 achieved SVR and were included in this analysis. 23 participants were relapsers.||Participants|||Number
771480|NCT00724477|Primary|Number of Participants Reaching the Targeted LDL-C Levels|"A subject was considered to have met targeted LDL-C levels (been controlled) if:
subject had no cardiovascular (CV) risk factors and level of LDL-C after initiating INEGY was lower than 2.2 g/L,
subject had only 1 CV risk factor and level of LDL-C after initiating INEGY was lower than 1.9 g/L,
subject had 2 CV risk factors and level of LDL-C after initiating INEGY was lower than 1.6 g/L,
subject had 3 or more CV risk factors and level of LDL-C after initiating INEGY was lower than 1.3 g/L,
subject had a high CV risk and level of LDL-C after initiating INEGY was lower than 1 g/L."|1 to 3 months after starting treatment|This was the efficacy population per protocol (PP) targeted for study treatment, and consisted of patients having taken INEGY at least once, with a primary efficacy criterion available (presence of risk factors or not plus lipid assessment after introduction of INEGY), and showing no major deviations from the protocol.||Participants|||Number
771481|NCT00727272|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|serial pharmacokinetic blood samples drawn within one hour prior to dosing (hour 0) and at 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hours after dose administration.|Data for 26 of the 27 subjects were used in the statistical analysis for Treatments A and C. The data for one subject, who dropped from the study prior to period III dosing (Treatment B), was included in the comparison of Treatments A versus C. Treatment A, Dose Adjusted to 300 mg was used to evaluate for dose proportionality.||ng-hr/mL||Standard Deviation|Mean
771482|NCT00727272|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic blood samples drawn within one hour prior to dosing (hour 0) and at 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hours after dose administration.|Data for 26 of the 27 subjects were used in the statistical analysis for Treatments A and C. The data for one subject, who dropped from the study prior to period III dosing (Treatment B), was included in the comparison of Treatments A versus C. Treatment A, Dose Adjusted to 300 mg was used to evaluate for dose proportionality.||ng-hr/mL||Standard Deviation|Mean
771483|NCT00727272|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that the drug reaches in the plasma.|serial pharmacokinetic blood samples drawn within one hour prior to dosing (hour 0) and at 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hours after dose administration.|Data for 26 of the 27 subjects were used in the statistical analysis for Treatments A and C. The data for one subject, who dropped from the study prior to period III dosing (Treatment B), was included in the comparison of Treatments A versus C. Treatment A, Dose Adjusted to 300 mg was used to evaluate for dose proportionality.||ng/mL||Standard Deviation|Mean
771484|NCT00727298|Secondary|Clinicians' Impression of Therapeutic Efficacy|Therapeutic efficacy was rated by the treating physician at each time point as moderate-to-clear improvement, no change, not assessable, mild-to-slight improvement, very good-to-full improvement, or worsened. Each time point was compared to the previous visit.|Week 6, Week 14, Week 22, Week 54, Week 102|The efficacy evaluable population consisted of all participants with baseline data available that received at least 3 infusions of study drug within 14+2 weeks.||Percentage of Participants|||Number
771485|NCT00727298|Secondary|Clinicians' Impression of Disease Severity From Baseline to Week 102|Participant severity of disease was assessed at baseline, Week 6, Week 14, Week 22, Week 54, and Week 102 on the basis of the treating clinician's opinion of the participant being normal, not at all ill, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, or extreme severe illness. Each time point was compared to the previous visit.|Baseline, Week 6, Week 14, Week 22, Week 54, Week 102|The efficacy evaluable population consisted of all participants with baseline data available that received at least 3 infusions of study drug within 14+2 weeks.||Percentage of Participants|||Number
771486|NCT00727298|Primary|Number of Participants Experiencing at Least One Adverse Event|An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the treatment, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the treatment, was also an adverse event.|Baseline to Month 24|The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.||Participants|||Number
771487|NCT00727311|Primary|Number of HCV-RNA Negative Participants at Follow-up|HCV-RNA was measured by PCR.|24 weeks post-treatment (Weeks 48 or 72, depending on genotype)|Number of participants with results at the 6 month follow-up examination||Participants|||Number
771488|NCT00727311|Primary|Number of Participants With Sustained Virologic Response (SVR)|SVR was defined as HCV-RNA negativity at EoT and at the follow-up 6 months after the EoT|24 weeks post-treatment (Week 48 or 72, depending on genotype)|Number of evaluable participants with follow-up information||Participants|||Number
771489|NCT00727311|Primary|Number of Participants With Early Virologic Response (EVR)|"EVR was defined as at least a 2 log reduction in HCV-RNA or HCV-RNA
negativity from baseline to Week 12"|Treatment Week 12|Number of evaluable participants at 12 weeks of treatment||Participants|||Number
771490|NCT00727311|Primary|Number of Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Negative Participants at End of Therapy (EoT)|HCV-RNA level was measured by polymerase chain reaction (PCR).|24 weeks in genotypes 2 and 3, and 48 weeks in genotypes 1, 4, 5, and 6|Number of evaluable participants at EoT||Participants|||Number
771491|NCT00727337|Primary|Words-in-Noise Test|Monosyllabic words (NU-6 female version) with a carrier phrase were presented auditory only in a multitalker babble.The participant is asked to repeat the last word of each phrase. The total number of correct words is input into the Spearman-Karber equation to derive a 50% point. This is the signal-to-noise ratio in dB that an individual requires to get 50% of the words correct. This test was completed at baseline and follow up visits.|Baseline and at 6 month follow up|||dB SNR||Standard Deviation|Mean
771492|NCT00727337|Secondary|Hearing Handicap Inventory for the Elderly||This outcome measure will assess changes from aided baseline to aided assessments made immediately and at six-months post treatment.||||||
771493|NCT00727337|Secondary|Abbreviated Profile of Hearing Aid Benefit||This outcome measure will assess changes from aided baseline to aided assessments made immediately and at six-months post treatment.||||||
771497|NCT00727506|Secondary|Number of Participants With Adverse Events, Graded According CTCAE - Phase II|Safety of Afatinib assessed based on the number of participants with adverse events, graded according to United States National Cancer Institute Common terminology Criteria for Adverse Events (US NCI CTCAE) Version 3.0. The CTCAE grades are: 1 (mild AE), 2 (moderate AE), 3 (severe AE), 4 (life-threatening or disabling AE), 5 (death related to AE).|From first administration of treatment until 28 days after last drug administration, up to 518 days.|Treated set||Participants|||Number
771498|NCT00727506|Secondary|Number of Participants With Adverse Events (AEs) Based on Intensity and Incidence of AE's - Phase II|Safety of afatinib as indicated by number of participants with adverse events based on intensity and incidence of AE's, especially skin reactions (rash, acne), gastrointestinal (GI) (Vomiting, nausea, diarrhea) and neurological.|From first administration of treatment until 28 days after last drug administration, up to 518 days.|Treated set||Participants|||Number
771499|NCT00727506|Secondary|Number of Participants With Investigator Defined Drug−Related AEs, AE Leading to Dose Reduction, AEs Leading to Discontinuation of Trial Drug and All SAE- Phase II|Safety was assessed based on number of participants with investigator defined drug−related AEs, AE leading to dose reduction, Adverse events (AEs) leading to discontinuation of trial drug and All Serious Adverse events (SAE).|From first administration of treatment until 28 days after last drug administration, up to 518 days.|Treated set||Participants|||Number
771500|NCT00727506|Secondary|Causes of Death - Phase I|Cause of the death reported during on treatment was due to disease progression.|From first administration of treatment until 28 days after last drug administration, up to 491 days.|Treated set||deaths|||Number
771501|NCT00727506|Secondary|Number of Participants With Adverse Events, Graded According CTCAE - Phase I|Safety of Afatinib assesed based on Number of participants with adverse events, graded according to United States National Cancer Institute Common terminology Criteria for Adverse Events (US NCI CTCAE) Version 3.0. The CTCAE grades are: 1 (mild AE), 2 (moderate AE), 3 (severe AE), 4 (life-threatening or disabling AE), 5 (death related to AE).|From first administration of treatment until 28 days after last drug administration, up to 491 days.|Treated set||Participants|||Number
771502|NCT00727506|Secondary|Number of Participants With Adverse Events (AEs) Based on Intensity and Incidence of AE's - Phase I|Safety of afatinib as indicated by number of participants with adverse events based on intensity and incidence of AE's, especially skin reactions (rash, acne), gastrointestinal (GI) (Vomiting, nausea, diarrhea) and neurological|From first administration of treatment until 28 days after last drug administration, up to 491 days.|Treated set||Participants|||Number
771503|NCT00727506|Secondary|Number of Participants With Investigator Defined Drug−Related AEs, AEs Leading to Discontinuation of Trial Drug, All Serious Adverse Events (AE) and Other Significant AEs - Phase I|Safety was assessed based on number of participants with investigator defined drug−related AEs, AEs leading to discontinuation of trial drug, All Serious Adverse events (AE) and other significant AEs (according to International Conference on Harmonisation (ICH) E3).|From first administration of treatment until 28 days after last drug administration, up to 491 days.|Treated set||Participants|||Number
771504|NCT00727506|Secondary|Number of Participants With Chromosomes (CEP10) Assessed by FISH|Number of participants with Chromosomes (CEP10) assessed by FISH for evaluation of molecular determinants of response to afatinib. Archival tumor samples from enrolled patients were collected and analyzed for Chromosomes (CEP10) by fluorescent in situ hybridization (FISH).|Baseline (during screening)|Randomized set||Participants|||Number
771505|NCT00727506|Secondary|Number of Participants With Chromosomes (CEP7) Assessed by FISH|Number of participants with Chromosomes (CEP7) assessed by FISH for evaluation of molecular determinants of response to afatinib. Archival tumor samples from enrolled patients were collected and analyzed for Chromosomes (CEP7) by fluorescent in situ hybridization (FISH).|Baseline (during screening)|Randomized set||Participants|||Number
771506|NCT00727506|Secondary|Number of Participants With PTEN Assessed by FISH|Number of participants with PTEN assessed by FISH for evaluation of molecular determinants of response to afatinib. Archival tumor samples from enrolled patients were collected and analyzed for PTEN by fluorescent in situ hybridization (FISH).|Baseline (during screening)|Randomized set||Participants|||Number
771507|NCT00727506|Secondary|Number of Participants With EGFR Assessed by FISH|Number of participants with EGFR assessed by FISH for evaluation of molecular determinants of response to afatinib. Archival tumor samples from enrolled patients were collected and analyzed for EGFR by fluorescent in situ hybridization (FISH).|Baseline (during screening)|Randomized set||Participants|||Number
771508|NCT00727506|Secondary|Number of Participants With PAKT Marker Assessed by IHC Test.|Number of participants with PAKT marker assessed by IHC test for evaluation of molecular determinants of response to afatinib. Archival tumor samples from enrolled patients were collected and analyzed for Serinethreonine kinase (PAKT) by immunohistochemistry (IHC) test.|Baseline (during screening)|Randomized set||Participants|||Number
771509|NCT00727506|Secondary|Number of Participants With PTEN Marker Assessed by IHC Test.|Number of participants with PTEN marker assessed by IHC test for evaluation of molecular determinants of response to afatinib. Archival tumor samples from enrolled patients were collected and analyzed for Phosphatase and Tensin Homologue – a tumor suppressor gene/protein (PTEN) by immunohistochemistry (IHC) test.|Baseline (during screening)|Randomized set||Participants|||Number
771510|NCT00727506|Secondary|Number of Participants With EGFR Marker Assessed by IHC Test.|Number of participants with EGFR marker assessed by IHC test for evaluation of molecular determinants of response to afatinib. Archival tumor samples from enrolled patients were collected and analyzed for Epidermal Growth Factor Receptor (EGFR) by immunohistochemistry (IHC) test|Baseline (during screening)|Randomized set||Participants|||Number
771511|NCT00727506|Secondary|Number of Participants With MGMT Marker Assessed by IHC Test.|Number of participants with MGMT marker assessed by IHC test for evaluation of molecular determinants of response to afatinib. Archival tumor samples from enrolled patients were collected and analyzed for O6-methylguanine-DNA methyltransferase (MGMT) by immunohistochemistry (IHC) test.|Baseline (during screening)|Randomized set||Participants|||Number
771512|NCT00727506|Secondary|Number of Participants With EGFRvIII Assessed by IHC Test.|Number of participants with the epidermal growth factor receptor variant III (EGFRvIII) assessed by IHC test for the evaluation of molecular determinants of response to afatinib. Archival tumor samples from enrolled patients were collected and analyzed for EGFRvIII by immunohistochemistry (IHC) test.|Baseline (during screening)|Randomized set||Participants|||Number
771514|NCT00727506|Secondary|t1/2 for Temozolomide|terminal half-life (t1/2) of temozolomide in presence and absence of afatinib|Before (-0.05 h) the first drug administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8 h after drug administration on Day 1 (in absence of afatinib) and Day 15 (in presence of afatinib) of treatment Cycle 1|PKS set||hours||Geometric Coefficient of Variation|Geometric Mean
771515|NCT00727506|Secondary|Tmax for Temozolomide|time from dosing to the maximum plasma concentration following the first dose of uniform intervals τ (tmax) of temozolomide in presence and absence of afatinib.|Before (-0.05 h) the first drug administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8 h after drug administration on Day 1 (in absence of afatinib) and Day 15 (in presence of afatinib) of treatment Cycle 1|PKS set||h||Full Range|Median
771516|NCT00727506|Secondary|Cmax for Temozolomide|maximum measured plasma concentration following the first dose of uniform intervals τ (Cmax) of temozolomide in presence and absence of afatinib.|Before (-0.05 h) the first drug administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8 h after drug administration on Day 1 (in absence of afatinib) and Day 15 (in presence of afatinib) of treatment Cycle 1|PKS set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
771517|NCT00727506|Secondary|AUC (0-8) for Temozolomide|Area under the plasma concentration-time curve over the time interval from zero to 08h (AUC (0-8)) of temozolomide in presence and absence of afatinib.|Before (-0.05 h) the first drug administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8 h after drug administration on Day 1 (in absence of afatinib) and Day 15 (in presence of afatinib) of treatment Cycle 1|PKS set||ng·h/mL||Geometric Coefficient of Variation|Geometric Mean
771518|NCT00727506|Secondary|Tmax,ss for Afatinib|time from dosing to the maximum plasma concentration of afatinib after multiple administration of 50 mg afatinib in presence and absence of 75 mg/m² temozolomide|Before (-0.05 h) the drug administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8 h and 24h after drug administration on Day 15 (in presence of temozolomide) and Day 28 (in absence of temozolomide) of treatment Cycle 1|PKS set||hour||Full Range|Median
771519|NCT00727506|Secondary|Cmax,ss for Afatinib|maximum measured plasma concentration of afatinib after multiple administration of 50 mg afatinib in presence and absence of 75 mg/m² temozolomide.|Before (-0.05 h) the drug administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8 h and 24h after drug administration on Day 15 (in presence of temozolomide) and Day 28 (in absence of temozolomide) of treatment Cycle 1|PKS set||ng/mL||Standard Deviation|Geometric Mean
771520|NCT00727506|Secondary|AUCτ,ss for Afatinib|Area under the plasma concentration-time curve of afatinib after multiple administration (AUCτ,ss) of 50 mg afatinib in presence and absence of 75 mg/m² temozolomide (TMZ).|Before (-0.05 h) the drug administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8 h and 24 h after drug administration on Day 15 (in presence of temozolomide) and Day 28 (in absence of temozolomide) of treatment Cycle 1|PKS Set and the patients who had enough PK samples for calculation of AUC. Pharmacokinetic set (PKS) : All patients who provided at least one blood sample were included in the Pharmacokinetic (PK) analysis.||ng·h/mL||Standard Deviation|Geometric Mean
771521|NCT00727506|Secondary|Progression-free Survival (PFS)- Phase II Part|Progression-free survival was defined as the duration between randomization and the date of the first of the two following events: progression or death.|from date of randomization until the date of first documented progression or death by any cause, whichever came first, assessed up to 9 Months.|Randomized set||Months||Full Range|Median
771522|NCT00727506|Secondary|Objective Tumor Response in Phase II|Objective Tumor Response is defined as complete response (CR) and partial response (PR) according to the MacDonald criteria assessed by central independent review. Only data collected until cut-off date July 15, 2016 were considered.|From randomization to until the date of first documented progression or data cutoff on July 15, 2016, whichever came first, with a mean treatment duration of 110.0 days|RS||participants|||Number
771523|NCT00727506|Secondary|Objective Tumor Response in Phase I|Objective Tumor Response is defined as complete response (CR) and partial response (PR) according to the MacDonald criteria assessed by central independent review.|From treatment start until the date of first documented progression or data cutoff at May 12, 2011, whichever came first, with a mean treatment duration of 69.7 days.|Patients treated in Phase I part||participants|||Number
771524|NCT00727506|Primary|Progression-free Survival (PFS-6) at Six Months - Phase II|"PFS-6 is defined as probability of patients surviving to six months after randomization without progression. Disease progression was evaluated by an independent review committee and by the investigators, independently. The evaluation by the independent review committee was used for the primary outcome measure. The measurement Number the estimated PFS-6 value from the Kaplan-Meier curve of PFS."|At six months after randomization|Randomised Set (RS). The randomised set includes all patients who were randomised to receive treatment in the Phase II part of the trial.||probablity of survival||95% Confidence Interval|Number
771525|NCT00727506|Primary|Number of Participants With DLT- Phase I|Number of Participants With Dose Limiting Toxicities (DLT) - Phase I Part|From randomization till data cut-off (10 Jun 2009), with a mean treatment duration of 51 days|||participants|||Number
771526|NCT00727558|Secondary|Inferior Region Corneal Staining|National Eye Institute (NEI) 0-3 scale: grade 0=normal, grade 1=mild, grade 2=moderate, grade 3=severe.|at 1 week of wear|Analysis includes participants who completed the study per protocol and had no missing data (n=243).||Units on a scale||Standard Error|Least Squares Mean
771527|NCT00727558|Secondary|Initial Comfort|"Rating of comfort immediately when you first put them on using the following scale: 0=N/A, 1= Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent."|at 1 week|Analysis includes participants who completed the study per protocol and had no missing data (n=240).||Units on a scale||Standard Error|Least Squares Mean
771528|NCT00727558|Secondary|End of Day Comfort|Rating of comfort at the end of the day using the following scale: 0=N/A, 1=Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent|at 1 week of wear|Analysis includes participants who completed the study per protocol and had no missing data (n=240).||Units on a scale||Standard Error|Least Squares Mean
771529|NCT00727558|Secondary|How Comfortable Eyes Feel at the End of the Day|"Rating of How comfortable did your eyes feel at the end of the day when wearing the contact lenses provided using the following scale: 1=extremely uncomfortable, 2= very uncomfortable, 3=slightly uncomfortable, 4=comfortable, 5=very comfortable."|at 1 week wear|Analysis includes participants who completed the study per protocol and had no missing data.||Units on a scale||Standard Error|Least Squares Mean
771530|NCT00727558|Secondary|Overall Handling|Rating of overall ease of handling using the following scale: 0=N/A, 1=Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent.|at 1 week of wear|Analysis includes participants who completed the study per protocol and had no missing data (n=240).||Units on a scale||Standard Error|Least Squares Mean
771531|NCT00727558|Primary|Measured Limbal Hyperemia|Measurement of redness of the limbus, graded using half-grade increments using the following scale: 0=none, 1=trace, 2=mild, 3=moderate, 4=severe.|at 1 week of wear.|Analysis includes participants who completed the study per protocol and had no missing data (n=243).||Units on a scale||Standard Error|Least Squares Mean
771532|NCT00727558|Primary|Overall Comfort|Single question: Comfort scale: 0=N/A, 1=Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent|at 1 week of wear.|Analysis includes participants who completed the protocol and had no missing data (n=240)||Units on a scale||Standard Error|Least Squares Mean
771533|NCT00727571|Secondary|Physical Performance: Lower Extremity Strength, Right Leg|Lower extremity strength test measures the maximum amount of weight a participant can lift one time throughout his/her range of motion. While supine, and using adjustable cuff weights, participants were asked to bend at their hip and knee and draw their heel along the bed towards their buttocks.|Weeks 2, 14, 26|"Enrolled patients with CKD and non-missing data at each time point (indicated by N)."||pounds||Standard Deviation|Mean
771534|NCT00727571|Secondary|Physical Performance: Lower Extremity Strength, Left Leg.|Lower extremity strength test measures the maximum amount of weight a participant can lift one time throughout his/her range of motion. While supine, and using adjustable cuff weights, participants were asked to bend at their hip and knee and draw their heel along the bed towards their buttocks.|Weeks 2, 14, 26|"Enrolled patients with CKD and non-missing data at each time point (indicated by N)."||pounds||Standard Deviation|Mean
771535|NCT00727571|Secondary|Physical Performance: Grip Strength|Grip strength was measured using an adjustable, hand-held, hydraulic grip strength dynamometer. While seated, participants were asked to grip the 2 bars of the dynamometer in their hand and slowly squeeze as hard as they can; then relax. The highest of three measurements was recorded.|Weeks 2, 14, 26|"Enrolled patients with CKD and non-missing data at each time point (indicated by N)."||pound-force||Standard Deviation|Mean
771536|NCT00727571|Secondary|Physical Performance: Time to Rise From Sitting to Standing|Participants were asked to stand from a seated position so that knees approximated full extension. Timing began from the point that the participant initiated the standing behavior to the point he/she was on his/her feet with knees at approximately full extension.|Weeks 2, 14, 26|"Enrolled patients with CKD and non-missing data at each time point (indicated by N)."||seconds||Inter-Quartile Range|Median
771537|NCT00727571|Secondary|Physical Performance: Duration Walked or Wheeled at Each Visit|The duration a participant was able to walk or propel themselves in a wheelchair during 10 minutes.|Weeks 2, 14, 26|"Enrolled patients with CKD and non-missing data at each time point (indicated by N)."||minutes||Standard Deviation|Mean
771538|NCT00727571|Secondary|Physical Performance: Speed Walked or Wheeled in a Maximum of 10 Minutes at Each Visit|Physical performance was measured for all patients with CKD (defined as estimated Glomerular Filtration Rate (eGFR) <60 mL/min/1.73m^2). The average speed a participant walked, with or without an assistive device, and stand-by assistance of one person or propelled themselves in their wheelchair with or without the use of their feet, over level ground, up to 10 minutes with up to two 30 second rest periods.|Weeks 2, 14 and 26|"Enrolled patients with CKD and non-missing data at each time point (indicated by N)."||feet per minute||Standard Deviation|Mean
771539|NCT00727571|Secondary|Estimated Glomerular Filtration Rate (GFR) for Participants With CKD|Estimated GFR measures how much blood the kidneys are filtering, and was calculated using 2 methods: 1. Modification of Diet in Renal Disease study (MDRD) formula: estimated GFR = 186 x [Serum creatinine]^-1.154 x [Age]^-0.203 x [0.742 if patient is female] x [1.210 if patient is black]. 2. Cockcroft-Gault formula: GFR = (140-age) * (Weight in kg) * (0.85 if female) / (72 * Serum Creatinine).|Weeks 1, 14 and 26|"Enrolled patients with CKD and non-missing data at each time point (indicated by N)."||mL/min/1.73 m^2||Standard Deviation|Mean
771540|NCT00727571|Secondary|Percentage of Participants With Anemia Related Conditions at Baseline|"The percentages of anemic subjects with iron deficiency, vitamin B12 deficiency, gastrointestinal (GI) bleed, chronic inflammation, and folate deficiency. Anemia of iron deficiency is defined as reduced serum iron, reduced transferrin saturation, ferritin less than 12 ng/mL plus increased Total Iron Binding Capacity (TIBC), per normal laboratory range. Anemia of chronic inflammation defined as reduced serum iron and transferrin saturation, increased or normal ferritin, and reduced or normal TIBC. GI bleed is based on the result of the stool guaiac sample(s) collected: A participant is considered to have GI bleed if one guaiac sample is positive, and not to have GI bleed only if all of his/her three stool guaiac samples were negative.
Vitamin B12 and folate deficiency based on standard laboratory ranges."|Baseline|Enrolled patients with anemia||Percentage of participants|||Number
771541|NCT00727571|Secondary|Number of Participants With Anemia|Anemia is defined using World Health Organization (WHO) criteria as Hemogloblin <12 g/dL in women, < 13 g/dL in men.|Baseline|All enrolled patients with available anemia lab results.||participants|||Number
771542|NCT00727571|Primary|Total Distance Walked or Wheeled in a Maximum of 10 Minutes at Each Visit|The distance a participant walked, with or without an assistive device and stand-by assistance of 1 person, or propelled him/herself in a wheelchair with or without the use of his/her feet, over level ground, during a period of up to 10 minutes including up to two 30-second rest periods (at weeks 2, 14 and 26).|Weeks 2, 14 and 26|"Enrolled patients with CKD and non-missing data at each time point (indicated by N)."||feet||Inter-Quartile Range|Median
771543|NCT00727597|Primary|Number of Subjects Developing Any Treatment-related Grade 3-4 Adverse Events||96 weeks|||participants|||Number
771544|NCT00727597|Primary|Number of Subjects Needing to Switch Comparator Drugs (FPV/r or EFV)|"Subjects were randomized and initiated treatment on one of the antiretroviral arms(FPV/r or EFV) at study Entry visit. Subjects would be switched for the follwing reasons:
To resolve a Grade 3 or 4 Adverse Event
The subject experienced a virologic failure (as defined in section 3.6.2)
The investigator believes the subject is at a significant risk for failing to comply with the protocol AND the investigator believes a regimen substitution is likely to resolve the compliance issue
The investigator believes there is any other significant safety concern for the subject associated with remaining on the current regimen (e.g., hypersensitivity reaction, increased risk of suicide)"|96 weeks|||participants|||Number
771545|NCT00727636|Primary|Antibody Titer to HPV 18|Geometric mean titer (95%CI)|Month 7|||milli-Merck units/mL||95% Confidence Interval|Geometric Mean
771546|NCT00727636|Primary|Antibody Titers to HPV 16|Geometric mean titer (95% CI)|Month 7|||milli-Merck units/mL||95% Confidence Interval|Geometric Mean
771547|NCT00727636|Primary|Antibody Titer to HPV 11||Month 7|Number of participants who completed all vaccine doses||milli-Merck units/mL||95% Confidence Interval|Geometric Mean
771549|NCT00727649|Secondary|Fecal Incontinence Severity Index Score, FISI|The patient-reported symptoms severity score, the Fecal Incontinence Severity Index (FISI), has 4 questions about the frequency of gas, mucus, liquid stool, and solid stool incontinence. Responses are weighted based on the patient rating of severity and a total score is calculated (range 0-61) with higher scores indicating a greater severity of symptoms.|baseline, 4 week and 12 weeks|||units on a scale||Standard Deviation|Mean
771550|NCT00727649|Primary|Percentage of Bowel Movements With Incontinence|After consent, 7-day bowel diary was assessed at baseline (2-week visit), during the last week of the 4-week intervention (6-week visit), during the second week of the 2-week wash-out period at 8-weeks, and during the last week of the second 4-week intervention (12 weeks). We compared the percentage of the total number of fecal incontinence episodes over the total number of bowel movements from a 7-day bowel diary from each time point between the groups.|4 weeks|||percentage of incontinent bowel movement||Standard Deviation|Mean
771551|NCT00727649|Primary|7-day Bowel Diary, Number of Fecal Incontinence Episodes|After consent, 7-day bowel diary was assessed at baseline (2-week visit), during the last week of the 4-week intervention (6-week visit), during the second week of the 2-week wash-out period at 8-weeks, and during the last week of the second 4-week intervention (12 weeks). The mean number of total fecal incontinence episodes from a 7-day bowel diary from each time point was compared between the groups.|6 weeks and 12 weeks|||Fecal incontinence episodes||Standard Deviation|Mean
771552|NCT00727714|Secondary|Changes in Serum/Plasma Inflammatory Markers Between Baseline and 32 h||0-32h|||ng/Litre||Full Range|Median
771553|NCT00727714|Secondary|Changes in FeNO Measurements Between Baseline (0h) and 32 h||0-32h|||ppb||Full Range|Median
771554|NCT00727714|Secondary|Changes in Serum/Plasma Inflammatory Markers During One Shift (6-8h)||Baseline and 6-8h|||ng/Litre||Full Range|Median
771555|NCT00727714|Secondary|Changes in FeNO Measurements During One Shift (6-8h)||baseline and 6-8h|Problems With the FeNO (NIOX) device lead to few (58) included in FeNO measurements||ppb||Full Range|Median
771556|NCT00727714|Primary|Changes in Lung Function Measurements During One Work Shift (6-8h)|Changes in lung function measurements during one work shift (6-8h), spirometry and gass diffusion capacity|baseline and 6-8h|||Litres||Standard Deviation|Mean
771557|NCT00727740|Primary|Reduction in Pancreatitis Rate|Pancreatitis was operationally defined as post-ERCP pancreatitis (PEP). PEP was defined as abdominal pain with elevated serum amylase level (3 times above the upper limit of normal). The change in Pancreatitis rate calculated as the percentage of participants with pancreatitis at baseline minus percentage of participants with pancreatitis at 24 hours.|24 hours|||percentage of participants with PEP|||Number
771558|NCT00727844|Primary|Number of Patients Converted to Sputum Culture Negative in Each Arm, With Data Censored at 4 Months.||Sputum smear conversion or max 4 months after the start of Linezolid therapy.|||participants|||Number
771559|NCT00727857|Secondary|Change From Baseline in Small Very Low Density Lipoprotein (V1+V2) Concentration|The change between Small Very Low Density Lipoprotein collected at final visit or week 24 and Small Very Low Density Lipoprotein collected at baseline|Baseline and Week 24|Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit||nmol/L||Standard Error|Least Squares Mean
771560|NCT00727857|Secondary|Change From Baseline in Medium-Intermediate Very Low Density Lipoprotein (V3+V4) Concentration|The change between Medium-Intermediate Very Low Density Lipoprotein collected at final visit or week 24 and Medium-Intermediate Very Low Density Lipoprotein collected at baseline|Baseline and Week 24|||nmol/L||Standard Error|Least Squares Mean
771561|NCT00727857|Secondary|Change From Baseline in Large-Chylomicrons Very Low Density Lipoprotein Concentration|The change between Large-Chylomicrons Very Low Density Lipoprotein collected at final visit or week 24 and Large-Chylomicrons Very Low Density Lipoprotein collected at baseline|Baseline and Week 24|||nmol/L||Standard Error|Least Squares Mean
771562|NCT00727857|Secondary|Change From Baseline in Mean Very Low Density Lipoprotein Particle Size|The change between Very Low Density Lipoprotein collected at final visit or week 24 and Very Low Density Lipoprotein collected at baseline.|Baseline and Week 24|||nm||Standard Error|Least Squares Mean
771563|NCT00727857|Secondary|Change From Baseline in Mean Very Low Density Lipoprotein Particle Concentration|The change between Very Low Density Lipoprotein collected at final visit or week 24 and Very Low Density Lipoprotein collected at baseline.|Baseline and Week 24|||nmol/L||Standard Error|Least Squares Mean
771564|NCT00727857|Secondary|Change From Baseline in Small High Density Lipoprotein (H1+H2) Concentration|The change between Small High Density Lipoprotein collected at final visit or week 24 and Small High Density Lipoprotein collected at baseline|Baseline and Week 24|||μmol/L||Standard Error|Least Squares Mean
771565|NCT00727857|Secondary|Change From Baseline in Intermediate-Medium High Density Lipoprotein (H3) Concentration|The change between Intermediate-Medium High Density Lipoprotein collected at final visit or week 24 and Intermediate-Medium High Density Lipoprotein collected at baseline|Baseline and Week 24|||μmol/L||Standard Error|Least Squares Mean
771566|NCT00727857|Secondary|Change From Baseline in Large High Density Lipoprotein (H4+H5) Concentration|The change between Large High Density Lipoprotein collected at final visit or week 24 and Large High Density Lipoprotein collected at baseline|Baseline and Week 24|||μmol/L||Standard Error|Least Squares Mean
771567|NCT00727857|Secondary|Change From Baseline in Mean High Density Lipoprotein Particle Size|The change between High Density Lipoprotein collected at final visit or week 24 and High Density Lipoprotein collected at baseline.|Baseline and Week 24|||nm||Standard Error|Least Squares Mean
771568|NCT00727857|Secondary|Change From Baseline in Mean High Density Lipoprotein Particle Concentration|The change between High Density Lipoprotein collected at final visit or week 24 and High Density Lipoprotein collected at baseline.|Baseline and Week 24|||μmol/L||Standard Error|Least Squares Mean
771569|NCT00727857|Secondary|Change From Baseline in Very Small Low Density Lipoprotein Concentration|The change between Very Small Low Density Lipoprotein collected at final visit or week 24 and Very Small Low Density Lipoprotein collected at baseline|Baseline and Week 24|||nmol/L||Standard Error|Least Squares Mean
771570|NCT00727857|Secondary|Change From Baseline in Small Low Density Lipoprotein Concentration|The change between Small Low Density Lipoprotein collected at final visit or week 24 and Small Low Density Lipoprotein collected at baseline|Baseline and Week 24|||nmol/L||Standard Error|Least Squares Mean
771573|NCT00727857|Secondary|Change From Baseline in Large Low Density Lipoprotein (L3) Concentration|The change between Large Low Density Lipoprotein collected at final visit or week 24 and Large Low Density Lipoprotein collected at baseline.|Baseline and Week 24|||nmol/L||Standard Error|Least Squares Mean
771574|NCT00727857|Secondary|Change From Baseline in Mean Low Density Lipoprotein Particle Size|The change between Low Density Lipoprotein collected at final visit or week 24 and Low Density Lipoprotein collected at baseline.|Baseline and Week 24|||nm||Standard Deviation|Least Squares Mean
771575|NCT00727857|Secondary|Change From Baseline in Mean Low Density Lipoprotein Particle Concentration|The change between Low Density Lipoprotein particle concentration collected at final visit or week 24 and Low Density Lipoprotein particle concentration collected at baseline.|Baseline and Week 24|Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit||nmol/L||Standard Error|Least Squares Mean
771576|NCT00727857|Secondary|Change From Baseline in Triglycerides|The change between Triglycerides collected at final visit or week 24 and Triglycerides collected at baseline.|Baseline and Week 24|Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit||mg/dL||Standard Error|Least Squares Mean
771577|NCT00727857|Secondary|Change From Baseline in High-Density Lipoprotein Cholesterol|The change between High-Density Lipoprotein Cholesterol collected at final visit or week 24 and High-Density Lipoprotein Cholesterol collected at baseline.|Baseline and Week 24|Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit||mg/dL||Standard Error|Least Squares Mean
771578|NCT00727857|Secondary|Change From Baseline in Low-Density Lipoprotein Cholesterol|The change between Low-Density Lipoprotein Cholesterol collected at final visit or week 24 and Low-Density Lipoprotein Cholesterol collected at baseline.|Baseline and Week 24|Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit||mg/dL||Standard Error|Least Squares Mean
771579|NCT00727857|Secondary|Change From Baseline in Total Cholesterol|The change between Total Cholesterol collected at final visit or week 24 and Total Cholesterol collected at baseline.|Baseline and Week 24|Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit||mg/dL||Standard Error|Least Squares Mean
771580|NCT00727857|Secondary|Change From Baseline in Adiponectin|The change between Adiponectin collected at final visit or week 24 and Adiponectin collected at baseline.|Baseline and Week 24|Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit||mcg/ml||Standard Error|Least Squares Mean
771581|NCT00727857|Secondary|Median Percent Change From Baseline in High Sensitivity C-reactive Protein|Measurement for High Sensitivity C-reactive Protein was collected at final visit or week 24 and at baseline. Percent change from baseline is calculated as: [(Week 24 - baseline levels)/baseline]*100|Baseline and Week 24|||percent||Full Range|Median
771582|NCT00727857|Secondary|Change From Baseline in Homeostasis Model Assessment - Insulin Resistance|The change between Homeostasis Model Assessment of Insulin Resistance collected at final visit or week 24 and Homeostasis Model Assessment of Insulin Resistance collected at baseline. Homeostasis Model Assessment measures insulin resistance, calculated by insulin times glucose, divided by a constant (22.5).|Baseline and Week 24|Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit||percent of insulin resistance||Standard Error|Least Squares Mean
771583|NCT00727857|Secondary|Change From Baseline in Fasting Insulin|The change between the Fasting Insulin value collected at final visit or week 24 and Fasting Insulin collected at baseline.|Baseline and Week 24|Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit||μIU/mL||Standard Error|Least Squares Mean
771584|NCT00727857|Secondary|Change From Baseline in Fasting Plasma Glucose|The change between the value of Fasting Plasma Glucose collected at final visit or week 24 and Fasting Plasma Glucose collected at baseline.|Baseline and Week 24|Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit||mg/dL||Standard Error|Least Squares Mean
771585|NCT00727857|Primary|Percent Change From Baseline in Glycosylated Hemoglobin|The change between the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at final visit or week 24 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 24|Participant must have baseline and at least one post-baseline value. Last Observation Carried Forward (LOCF) for missing final/week 24 visit||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
771586|NCT00727909|Primary|Percentage of Participants That Selected a Particular Type of Hearing Aid||At the end of the 6 month trial (after having worn each set of hearing aids for 2 months each)|||percentage of participants|||Number
771587|NCT00727961|Primary|Number of Participants With Progression|Progressive disease was defined as 25% or greater increase in the size of measurable lesion. The reappearance of any lesion or clear worsening of assessable disease or the appearance of any new lesion was also considered as progressive disease as measured by chest x-ray, computed tomography scan, and magnetic resonance imaging.|4 weeks after chemotherapy completed|||Participants|||Number
771588|NCT00727961|Primary|Number of Participants With Stabilization|All other subjects (except complete or partial responders and those with progression [see prior definitions]) were classified as stable disease as measured by chest x-ray, computed tomography scan, and magnetic resonance imaging.|4 weeks after chemotherapy completed|||Participants|||Number
771589|NCT00727961|Primary|Number of Participants With Partial Response|Required 50 percent or greater decrease in sum of products of all bidimensionally measurable lesions without progression of assessable disease and no new lesions as measured by chest x-ray, computed tomography scan, and magnetic resonance imaging.|4 weeks after chemotherapy completed|||Participants|||Number
771590|NCT00727961|Secondary|Mean Survival Time During the Study|Mean time to the occurrence of death|from the beginning of study drug administration up to 18 months|||days||95% Confidence Interval|Mean
771591|NCT00727961|Secondary|Median Time to Progression|Median time to the occurence of progression. Progression was defined as 25 percent or greater increase size of measurable lesion. Reappearance of lesion, worsening of assessable disease or appearance new lesions were considered progression as measured by chest x-ray, computed tomography scan, and magnetic resonance imaging.|from the beginning of study drug administration up to 4 weeks after chemotherapy completed|||days||95% Confidence Interval|Median
771592|NCT00727961|Secondary|Mean Time to Positive (Partial) Treatment Response Achievement|"Time to the occurence of partial effect achievement as measured by chest x-ray, computed tomography scan, and magnetic resonance imaging.
Partial response required a 50 percent or greater decrease in the sum of the products of all bidimensionally measurable lesions without progression of any assessable disease and no new lesions."|from the beginning of study drug administration up to 4 weeks after chemotherapy completed|||days||Standard Deviation|Mean
771593|NCT00727961|Primary|Number of Participants With Complete Response|Complete response was defined as complete disappearance of all measurable and assessable disease with no new disease or disease-related symptoms as measured by chest x-ray, computed tomography scan, and magnetic resonance imaging.|4 weeks after chemotherapy completed|||participants|||Number
771594|NCT00728130|Secondary|The Presence or Absence of Carcinoma Within Each of the Assessed Nodes Will be Documented, as Well as Extracapsular Spread.|Pathological detection of carcinoma within each of the dissected nodes reported as node groups.|Post surgical time point|||carcinoma positive nodes||Standard Deviation|Mean
771595|NCT00728130|Primary|the Number of Lymph Nodes: 1. Identified Within Each Lymph Node Group, 2.Located Within the Submandibular Gland, and 3. Within the Fibrofatty Contents Lying Deep to the Submandibular Gland.|The number of head/ neck lymph nodes in pre-defined groups: Preglandular, Prevascular, Retrovascular, and Retroglandular as well as the number of nodes within the submandibular gland and within the fibrofatty contents lying deep to the submandibular gland.|Post Surgical Time point|||nodes||Standard Deviation|Mean
771596|NCT00728182|Other Pre-specified|Modified Rankin Scale (mRS)- Ruptured Aneurysm Subjects|The mRS is a measure of global disability that has been widely applied for evaluating recovery from stroke. Scores range from 0 to 6, with higher scores indicating greater disability. A score of 0 indicates no residual symptoms; 1 = no significant disability/able to carry out all usual activities, despite some symptoms; 2 = slight disability; 3 = moderate disability; 4 = moderately severe disability; 5 = severe disability; 6 = death. The number of participants scoring 0-2 on the mRS at Day 30 with ruptured aneurysms was compared in both treatment groups(pre-specified subgroup analysis).|Enrolment, Day 30|||No. of participants with mRS 0-2|||Number
771597|NCT00728182|Other Pre-specified|National Institutes of Health Stroke Scale (NIHSS) - Ruptured Aneurysm Subjects|The NIHSS is a standardized neurological method to measure disability and recovery after stroke. Scores range from 0 to 42, with higher scores indicating increasing severity. Scores were dichotomized into 0-1 (good outcome) versus 2 or above. The number of participants scoring 0-1 on the NIHSS at Day 30 was compared for participants with ruptured aneurysms in both treatment groups(pre-specified subgroup analysis).|Enrolment, Day 30|All subjects who entered the study with a ruptured aneurysm, who received study drug and outcome assessment at Day 30.||No. of participants with NIHSS 0-1|||Number
771598|NCT00728182|Other Pre-specified|Volume of New DWI Lesions (MRI) - Ruptured Aneurysm Subjects|Volume of new DWI lesions as defined by MRI at 12-95 hours postdose(pre-specified subgroup analysis)|Enrolment, Day 2-4|All subjects who entered the study with a ruptured aneurysm, who received study drug and an analyzable MRI at 12-95 hours postdose.||mm^3||Standard Deviation|Mean
771599|NCT00728182|Other Pre-specified|Number of New FLAIR Lesions (MRI) - Ruptured Aneurysm Subjects|Number of new ischemic lesions as defined by FLAIR MRI at 12-95 hours postdose(pre-specified subgroup analysis)|Enrolment, Day 2-4|All subjects who entered the study with a ruptured aneurysm, who received study drug and an analyzable MRI at 12-95 hours postdose.||Lesions||Standard Deviation|Mean
771600|NCT00728182|Other Pre-specified|Number of New DWI Lesions (MRI) - Ruptured Aneuryms Subjects|Number of new ischemic lesions as defined by DWI MRI at 12-95 hours postdose(pre-specified subgroup analysis)|Enrolment, Day 2-4|All subjects who entered the study with a ruptured aneurysm, who received study drug and an analyzable MRI at 12-95 hours postdose.||Lesions||Standard Deviation|Mean
771601|NCT00728182|Other Pre-specified|Volume of New FLAIR Lesions (MRI) - Ruptured Aneurysm Subjects|Volume of new ischemic lesions as defined by FLAIR MRI at 12-95 hours postdose (pre-specified subgroup analysis)|Enrolment, Days 2-4|All subjects who entered the study with a ruptured aneurysm, who received study drug and an analyzable MRI at 12-95 hours postdose.||mm^3||Standard Deviation|Mean
771602|NCT00728182|Secondary|Modified Rankin Scale (mRS).|The mRS is a measure of global disability that has been widely applied for evaluating recovery from stroke. Scores range from 0 to 6, with higher scores indicating greater disability. A score of 0 indicates no residual symptoms; 1 = no significant disability/able to carry out all usual activities, despite some symptoms; 2 = slight disability; 3 = moderate disability; 4 = moderately severe disability; 5 = severe disability; 6 = death. The number of participants scoring 0-2 on the mRS at Day 30 was compared in both treatment groups.|Enrolment, Day 30|All patients who received study drug and an outcome assessment at Day 30||No. of participants with mRS 0-2|||Number
771603|NCT00728182|Secondary|National Institutes of Health Stroke Scale (NIHSS).|The NIHSS is a standardized neurological method to measure disability and recovery after stroke. Scores range from 0 to 42, with higher scores indicating increasing severity. Scores were dichotomized into 0-1 (good outcome) versus 2 or above. The number of participants scoring 0-1 on the NIHSS at Day 30 was compared for both groups.|Enrolment, Day 30|All patients who received study drug and outcome assessment at Day 30.||No. of participants with NIHSS 0-1|||Number
771604|NCT00728182|Secondary|Volume of New DWI Lesions (MRI)|Volume of new DWI lesions as defined by MRI at 12-95 hours postdose.|Enrolment, Days 2-4|All patients who received study drug and an analyzable MRI at 12-95 hours postdose.||mm^3||Standard Deviation|Mean
771605|NCT00728182|Secondary|Number of New FLAIR Lesions (MRI)|Number of new ischemic lesions as defined by FLAIR MRI at 12-95 hours postdose.|Enrolment, Days 2-4|All patients who received study drug and an analyzable MRI scan at 12-95 hours postdose.||Lesions||Standard Deviation|Mean
771606|NCT00728182|Secondary|Number of New DWI Lesions (MRI)|Number of new ischemic lesions as defined by DWI MRI at 12-95 hours postdose.|Enrolment, Day 2-4|All patients who received study drug and an analyzable MRI at 12-95 hours postdose.||Lesions||Standard Deviation|Mean
771607|NCT00728182|Primary|Volume of New FLAIR Lesions(MRI)|Volume of new ischemic lesions as defined by FLAIR MRI at 12-95 hours postdose|Enrolment, Days 2-4|All study patients who received study drug and an analyzable MRI at 12-95 hours postdose.||mm^3||Standard Deviation|Mean
771678|NCT00728988|Secondary|Percentage of Participants With Elevated Creatine Kinase-MB (CK-MB)|CK-MB above the upper limit of normal range from baseline (biomarker of myocardial injury); normal range: 0-5.0 nanograms per milliliter (ng/mL).|8 hours, 24 hours and 30 days post PCI|FAS. N = number of participants with baseline and at least one post-baseline response.||percentage of participants|||Number
771608|NCT00728260|Primary|Summary of Diagnoses With Elevated Findings for Risk-Window vs. Control-Window Comparisons at the 5% Significance Level.|Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each comparison window. Clinical setting is given in parenthesis as (H) for hospital.|Day 31 up to Day 180 post-vaccination|All persons who received Menactra vaccine during the study period were included in the analysis.||Events per 1,000 person-months|||Number
771609|NCT00728260|Other Pre-specified|Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination From Inpatient Database – All Ages Combined|Only persons who received Menactra vaccine during the study period were surveyed and included in this outcome.|Day 0 up to 6 months post-vaccination|Only persons who received Menactra vaccine during the study period were included in the analysis.||Events per 1,000 doses|||Number
771610|NCT00728260|Primary|Summary of Diagnoses With Elevated Findings for Risk-Window vs. Control-Window Comparisons at the 5% Significance Level.|Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each comparison window. Clinical setting is given in parenthesis as (H) for hospital.|Day 0 up to Day 30 post-vaccination|All persons who received Menactra vaccine during the study period were included in the analysis.||Events per 1,000 person-months|||Number
771611|NCT00728416|Secondary|Change From Baseline in Average AM/PM PRIOR Total Nasal Symptom Score Over 15 Days|Total nasal symptom score (TNSS) is a composite of 4 symptoms, each is scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total can range from 0 to 12. PRIOR (the subject's status over the previous 12 hours [reflective]). Baseline is the average score from the 3 days prior to the first dose of study drug.|15 days of treatment|1 participant without baseline value excluded from the Placebo Nasal Spray population.||Units on a scale||95% Confidence Interval|Least Squares Mean
771612|NCT00728416|Primary|Change From Baseline in Average AM/PM PRIOR Nasal Congestion Score Over 15 Days|Nasal congestion was scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. PRIOR (the subject's status over the previous 12 hours [reflective]). Baseline is the average score from the 3 days prior to the first dose of study drug.|15 days of treatment|1 participant without baseline value excluded from the Placebo Nasal Spray population.||Units on a scale||95% Confidence Interval|Least Squares Mean
771613|NCT00728468|Other Pre-specified|Ratio of Dextromethorphan Area Under the Curve to Dextrorphan Area Under the Curve on Cycle 2 Day 7|Dextrorphan is an active metabolite of dextromethorphan.|Cycle 2 Day 7: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose|Ratio of AUC was a derived parameter. As the primary endpoint for the study was not met, only the primary parameter AUC was analyzed and reported. Other parameters were not derived for this study based on investigator’s decision.|||||
771614|NCT00728468|Other Pre-specified|Ratio of Dextromethorphan Area Under the Curve to Dextrorphan Area Under the Curve 3 Days Prior to PF-00299804 Dosing|Dextrorphan is an active metabolite of dextromethorphan.|Day -3: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose|Ratio of AUC was a derived parameter. As the primary endpoint for the study was not met, only the primary parameter AUC was analyzed and reported. Other parameters were not derived for this study based on investigator’s decision.|||||
771615|NCT00728468|Secondary|Time to Tumor Progression (TTP)|Time in months from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever comes first. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.437. Tumor progression was determined from oncologic assessment data (where data meet the criteria for PD).|Baseline, end of every even-numbered cycle until disease progression up to end of treatment (up to 18 months)|All enrolled participants||months||95% Confidence Interval|Median
771616|NCT00728468|Secondary|Duration of Response (DR)|Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Baseline, end of every even-numbered cycle until disease progression up to end of treatment (up to 18 months)|Participants with a response (CR or PR) in response analysis set.||weeks||95% Confidence Interval|Median
771617|NCT00728468|Secondary|Best Overall Response (BOR)|BOR: investigator assessment by Response Evaluation Criteria in Solid Tumors (RECIST), recorded from treatment start until disease progression/recurrence. Complete Response: disappearance of all lesions. Partial Response (PR): >=30% decrease in sum of longest diameters (SLDs) of target lesions (TLs) taking as reference baseline SLD. Progressive disease (PD): >=20% increase in SLD of TLs taking as reference smallest SLD since treatment start, or appearance of >=1 new lesion. Stable disease: neither shrinkage for PR nor increase for PD taking as reference smallest SLD since treatment start.|Baseline, end of every even-numbered cycle until disease progression up to end of treatment (up to 18 months)|Response anslysis set: all enrolled participants who received at least 1 dose of study medication and had an adequate baseline tumor assessment.||participants|||Number
771618|NCT00728468|Primary|Urinary Metabolic Ratio (UMR) of Dextromethorphan to Dextrorphan on Cycle 2 Day 7|The UMR was calculated as the ratio of the amount of dextrmotherphan excreted in urine from time zero to 8 hours post-dose on Day 7 to the amount of dextrorphan excreted in urine from time zero to 8 hours post-dose on Day 7.|8 hours after dosing on Day 7|PK parameter analysis population||ratio||Standard Deviation|Mean
771619|NCT00728468|Primary|Urinary Metabolic Ratio (UMR) of Dextromethorphan to Dextrorphan 3 Days Prior to PF-00299804 Dosing|The UMR was calculated as the ratio of the amount of dextrmotherphan excreted in urine from time zero to 8 hours post-dose on Day -3 to the amount of dextrorphan excreted in urine from time zero to 8 hours post-dose on Day -3.|8 hours after dosing on Day -3|PK parameter analysis population: all participants enrolled who were extensive metabolizers (EM), & treated who had at least 1 PK parameter of primary interest in at least 1 treatment period. EMs were defined as participants with a baseline UMR ≤0.3 & were either ultrarapid, extensive, or intermediate metabolizers as predicted by CYP2D6 genotyping.||ratio||Standard Deviation|Mean
771646|NCT00728689|Primary|Pharmacokinetic Parameters for a Single Dose of ST-246 Form I vs. Form V: Tmax|Time to maximum plasma concentration(Tmax; hrs) for Forms I and V were calculated from [plasma] vs time profiles.|Post-dose samples at 0.5,1,2,3,4,8,12,24,36,48,72 hrs|Both groups started with 12 particpants. Form V group lost a particpant during wash-out period due to death in the family.||hours||Standard Deviation|Mean
771620|NCT00728468|Primary|Oral Clearance For Dextromethorphan on Cycle 2 Day 7|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Cycle 2 Day 7: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose|Results not reported as data did not support calculation since levels of dextromethorphan were not tracked long enough for reliable estimation.|||||
771621|NCT00728468|Primary|Oral Clearance For Dextromethorphan 3 Days Prior to PF-00299804 Dosing|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Day -3: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose|Results not reported as data did not support calculation since levels of dextromethorphan were not tracked long enough for reliable estimation.|||||
771622|NCT00728468|Primary|Plasma Decay Half-Life (t1/2) For Dextrorphan on Cycle 2 Day 7|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Dextrorphan is an active metabolite of dextromethorphan.|Cycle 2 Day 7: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose|PK analysis population included all participants that were extensive metabolizers and treated, had at least 1 of PK parameters of primary interest in at least 1 treatment period. Here, N (number of participants analyzed) signifies who received PF-00299804 daily without interruptions or dose reductions prior to Day 7 of Cycle 2.||hours||Standard Deviation|Mean
771623|NCT00728468|Primary|Plasma Decay Half-Life (t1/2) For Dextrorphan 3 Days Prior to PF-00299804 Dosing|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Dextrorphan is an active metabolite of dextromethorphan.|Day -3: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose|PK analysis population included all participants that were extensive metabolizers and treated, had at least 1 of PK parameters of primary interest in at least 1 treatment period. Here, N (number of participants analyzed) signifies who received PF-00299804 daily without interruptions or dose reductions prior to Day 7 of Cycle 2.||hours||Standard Deviation|Mean
771624|NCT00728468|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) For Dextromethorphan and Dextrorphan on Cycle 2 Day 7|Dextrorphan is an active metabolite of dextromethorphan.|Cycle 2 Day 7: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose|PK analysis population included all participants that were extensive metabolizers and treated, had at least 1 of PK parameters of primary interest in at least 1 treatment period. Here, N (number of participants analyzed) signifies who received PF-00299804 daily without interruptions or dose reductions prior to Day 7 of Cycle 2.||hours||Full Range|Median
771625|NCT00728468|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) For Dextromethorphan and Dextrorphan 3 Days Prior to PF-00299804 Dosing|Dextrorphan is an active metabolite of dextromethorphan.|Day -3: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose|PK analysis population included all participants that were extensive metabolizers and treated, had at least 1 of PK parameters of primary interest in at least 1 treatment period. Here, N (number of participants analyzed) signifies who received PF-00299804 daily without interruptions or dose reductions prior to Day 7 of Cycle 2.||hours||Full Range|Median
771626|NCT00728468|Primary|Maximum Observed Plasma Concentration (Cmax) For Dextromethorphan and Dextrorphan on Cycle 2 Day 7|Dextrorphan is an active metabolite of dextromethorphan.|Cycle 2 Day 7: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose|PK analysis population included all participants that were extensive metabolizers and treated, had at least 1 of PK parameters of primary interest in at least 1 treatment period. Here, N (number of participants analyzed) signifies who received PF-00299804 daily without interruptions or dose reductions prior to Day 7 of Cycle 2.||ng/mL||Standard Deviation|Mean
771627|NCT00728468|Primary|Maximum Observed Plasma Concentration (Cmax) For Dextromethorphan and Dextrorphan 3 Days Prior to PF-00299804 Dosing|Dextrorphan is an active metabolite of dextromethorphan.|Day -3: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose|PK analysis population included all participants that were extensive metabolizers and treated, had at least 1 of PK parameters of primary interest in at least 1 treatment period. Here, N (number of participants analyzed) signifies who received PF-00299804 daily without interruptions or dose reductions prior to Day 7 of Cycle 2.||ng/mL||Standard Deviation|Mean
771628|NCT00728468|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) For Dextrorphan on Cycle 2 Day 7|AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf). Dextrorphan is an active metabolite of dextromethorphan.|Cycle 2 Day 7: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose|PK analysis population included all participants that were extensive metabolizers and treated, had at least 1 of PK parameters of primary interest in at least 1 treatment period. Here, N (number of participants analyzed) signifies who received PF-00299804 daily without interruptions or dose reductions prior to Day 7 of Cycle 2.||ng*hr/mL||Standard Deviation|Mean
771629|NCT00728468|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) For Dextrorphan 3 Days Prior to PF-00299804 Dosing|AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf). Dextrorphan is an active metabolite of dextromethorphan.|Day -3: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose|PK analysis population included all participants that were extensive metabolizers and treated, had at least 1 of PK parameters of primary interest in at least 1 treatment period. Here, N (number of participants analyzed) signifies who received PF-00299804 daily without interruptions or dose reductions prior to Day 7 of Cycle 2.||ng*hr/mL||Standard Deviation|Mean
771647|NCT00728689|Primary|Pharmacokinetic Parameters for a Single Dose of ST-246 Form I vs. Form V: Cmax|Maximum drug concentration in plasma, determined directly from individual concentration-time data (Cmax)|Post-dose samples at 0.5,1,2,3,4,8,12,24,36,48,72 hrs|Both groups started with 12 particpants as 'per protocol'. Form V group lost a particpant during wash-out period due to death in the family.||ng/mL||Standard Deviation|Mean
771630|NCT00728468|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) For Dextromethorphan and Dextrorphan on Cycle 2 Day 7|Area under the plasma concentration time-curve from time zero (pre-dose) to the last measured concentration (AUClast). Dextrorphan is an active metabolite of dextromethorphan.|Cycle 2 Day 7: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose|PK analysis population included all participants that were extensive metabolizers and treated, had at least 1 of PK parameters of primary interest in at least 1 treatment period. Here, N (number of participants analyzed) signifies who received PF-00299804 daily without interruptions or dose reductions prior to Day 7 of Cycle 2.||ng*hr/mL||Standard Deviation|Mean
771631|NCT00728468|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) For Dextromethorphan and Dextrorphan 3 Days Prior to PF-00299804 Dosing|Area under the plasma concentration time-curve from time zero (pre-dose) to the last measured concentration (AUClast). Dextrorphan is an active metabolite of dextromethorphan.|Day -3: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose|Pharmacokinetic (PK) analysis population included all participants that were extensive metabolizers and treated, had at least 1 of PK parameters of primary interest in at least 1 treatment period. Here, N (number of participants analyzed) signifies who received PF-00299804 daily without interruptions or dose reductions prior to Day 7 of Cycle 2.||nanograms*hour/milliliter (ng*hr/mL)||Standard Deviation|Mean
771632|NCT00728481|Primary|Symptomatic Response to Treatment|"Subjects with Esophageal eosinophilia experiencing a response in their dysphagia symptoms to treatment. Symptomatic improvement in symptoms was defined as a score of at least two levels lower than the baseline dysphagia symptom question on the Mayo Dysphagia Questionnaire-30 days (MDQ-30).
Dysphagia symptoms were determined based on the MDQ-30 question: 'How would you rate the severity of your trouble swallowing in the past 30 days' with a 5 point scale ranging from 'does not bother me at all' to 'very severe, markedly affects my lifestyle'. Patients must have marked a score of 3 or higher corresponding to 'Moderate, cannot be ignored, but does not affect my lifestyle' to be included in the study."|Baseline, 6 months|||Participants|||Number
771633|NCT00728481|Secondary|Participants With Presence of Erosive Esophagitis at Six Month Endoscopy||Baseline, 6 months|||participants|||Number
771634|NCT00728481|Secondary|Participants With Presence of Esophageal Rings/Furrows at Six Month Endoscopy|Multiple concentric rings or furrows of the esophagus is an endoscopic finding traditionally ascribed to eosinophilic esophagitis.|Baseline, 6 months|||participants|||Number
771635|NCT00728481|Secondary|Change in Dysphagia Symptoms in Subjects With Non-significant Histological Response to Treatment|Dysphagia symptoms were determined based on the Mayo Dysphagia Questionnaire-30 days (MDQ-30), using the question: 'How would you rate the severity of your trouble swallowing in the past 30 days' with a 5 point scale ranging from 'does not bother me at all' to 'very severe, markedly affects my lifestyle'. Patients must have marked a score of 3 or higher corresponding to 'Moderate, cannot be ignored, but does not affect my lifestyle' to be included in the study.|Baseline, 6 months|The analysis population for this item only included subjects with a non-significant histologic response. Subjects were considered to have a histological response to treatment if both sets of 6-month biopsies (from distal & mid-esophagus) had, on average, less than 5 eos/hpf.||Participants|||Number
771636|NCT00728481|Secondary|Change in Dysphagia Symptoms in Subjects With Histological Response to Treatment|Dysphagia symptoms were determined based on the Mayo Dysphagia Questionnaire-30 days (MDQ-30), using the question: 'How would you rate the severity of your trouble swallowing in the past 30 days' with a 5 point scale ranging from 'does not bother me at all' to 'very severe, markedly affects my lifestyle'. Symptomatic improvement was defined as only an improvement of 2 levels on this question.|Baseline, 6 months|The analysis population includes only subjects with a histologic response. Subjects were considered to have a histological response to treatment if both sets of biopsies (from distal & mid-esophagus) had, on average, less than 5 eos/hpf.||Participants|||Number
771637|NCT00728481|Primary|Histological Response to Treatment|Subjects with Esophageal eosinophilia experiencing a histological response to treatment. Subjects were considered to have histological response to treatment if both sets of biopsies (from the distal and mid-esophagus) had, on average, less than 5 eosinophils per high power field (eos/hpf) at the 6-month biopsies.|Baseline, 6 months|||Participants|||Number
771638|NCT00728494|Primary|The Number of Participants Who Relapsed at 6 Months Post-treatment|Participants who relapse are defined as having an undetectable HCV-RNA at the end of treatment but detectable HCV-RNA at 6 months post-treatment|Measured at end of treatment and 6 months post-treatment|||Participants|||Number
771639|NCT00728494|Primary|The Number of Participants With a Sustained Virologic Response at 6 Months Post-treatment|Sustained virologic response is defined as having an undetectable hepatitis C virus ribonucleic acid (HCV-RNA) at the end of treatment and 6 months post-treatment|Measured at 6 months post-treatment|||Participants|||Number
771640|NCT00728494|Secondary|Average Dosage of Rebetol|Rebetol dosage was expressed in milligrams per kilogram of body weight per day.|Up to 48-week treatment duration|||mg/kg/day||Standard Deviation|Mean
771641|NCT00728494|Secondary|Average Dosage of PegIntron|Dosage of PegIntron was expressed in terms of micrograms of PegIntron received per kilogram of participant's body weight per week|Up to 48-week treatment duration|||micrograms/kg/week||Standard Deviation|Mean
771642|NCT00728494|Secondary|Average Length of Treatment|Participant adherence to therapy was compared between participants who received vs not received a patient assistance program in addition to their PegIntron/Rebetol treatment.|Maximum 48-week treatment duration|||Participants|||Number
771643|NCT00728494|Primary|The Number of Participants Who Complete Treatment With PegIntron/Rebetol Therapy for Hepatitis C|Participant adherence to therapy was compared between participants treated with PegIntron/Rebetol either with or without a patient assistance program|At the end of the 48-week treatment period|||Participants|||Number
771644|NCT00728507|Primary|To Compare the Safety and Tolerability of the 2 Intensive Phase Regimens.|Study was prematurely terminated and data was not collected for this outcome measure.|Weekly or more frequent||||||
771645|NCT00728507|Primary|To Compare, by Treatment Group, the Percentage of Patients With a Negative Sputum Culture at the End of Intensive Phase Therapy.|LJ culture conversion|Week 8|modified intention to treat population||percentage of participants|||Number
771679|NCT00728988|Secondary|Percentage of Participants With Major Adverse Cardiac Events (MACE) (Incidence of MACE) at 24 Hours Post-PCI|Percentage calculated as: (number of participants who experienced MACE within 24 hours post PCI) divided by (number of participants who experienced PCI) * 100.|24 hours post PCI|FAS.||percentage of participants|||Number
771648|NCT00728689|Primary|Pharmacokinetic Parameters for a Single Dose of ST-246 Form I vs. Form V: AUC0-∞|Area under the drug concentration-time curve from time zero to infinity (AUC0-∞; ng*hr/mL).|Post-dose samples at 0.5,1,2,3,4,8,12,24,36,48,72 hrs|Both groups started with 12 particpants. Outlier values were excluded from analyses for 3 subject PK profiles (one Form I and 2 Form V). Form V group lost a particpant during wash-out period due to death in the family.||ng*hr/mL||Standard Deviation|Mean
771649|NCT00728689|Primary|Pharmacokinetic Parameters for a Single Dose of ST-246 Form I vs. Form V: AUC0-τ|Area under the drug concentration-time curve from time zero to time t, where t is the last timepoint with a drug concentration ≥ lowest obtainable quantification (AUC0-τ; ng*hr/mL).|Post-dose samples at 0.5,1,2,3,4,8,12,24,36,48,72 hrs|Both groups started with 12 particpants. Form V group lost a particpant during wash-out period due to death in the family.||ng*hr/mL||Standard Deviation|Mean
771650|NCT00728689|Primary|Pharmacokinetic Parameters for a Single Dose of ST-246 Form I vs. Form V: t½|Mean terminal half-life (t½; hrs) for Forms I and V were calculated from [plasma] vs time profiles.|Post-dose samples at 0.5,1,2,3,4,8,12,24,36,48,72 hrs|Both groups started with 12 particpants. Outlier values were excluded from the half-life analyses for 3 subject PK profiles (one Form I and 2 Form V). Form V group lost a particpant during wash-out period due to death in the family.||hours||Standard Deviation|Mean
771651|NCT00728689|Secondary|Number of Study Participants Who Tolerated a Single Dose of ST-246 Form I vs. Form V as Determined by No Clinically Significant Changes in Safety Parameters|"Evaluated safety parameters included:
physical examination/vital signs
electrocardiograms (heart rate, PR interval, QRS duration, QT interval, and QTc Bazett)
laboratory safety tests (hematology, chemistry, urinalysis)
adverse events For a), b) and c), summary statistics (mean,SD, median, minm, maxm)for values, and changes from baseline(Day 1 pre-dose) to each timepoint, were measured and compared to laboratory normal reference ranges. Values for a)- d) were assigned grades according to DAIDS AE Grading Table. Any Grade of 3 or higher was considered severe and significant."|4 weeks|Both groups started with 12 particpants. Form V group lost a particpant during wash-out period due to death in the family.||participants|||Number
771652|NCT00728728|Secondary|Clinical Global Impressions (CGI) Scale|The CGI scale provides a brief, stand-alone assessment of the clinician's view of the patient's global functioning prior to and after initiating a study medication. The CGI comprises two companion one-item measures evaluating the severity of psychopathology from 1 to 7 and change from the initiation of treatment on a similar seven-point scale. Thus, scores range from 2 to 14, with lower scores representing better outcomes.|Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10)|Missing data for a total of 5 participants for the CGI.||score||Standard Error|Mean
771653|NCT00728728|Secondary|Positive and Negative Syndrome Scale (PANSS)|The PANSS measures positive and negative symptoms of schizophrenia through administering a structured interview. After the interview, 25 PANSS items are each rated 1 (absent) to 7 (extreme). These items are organized into five scales: Negative, Positive, Dysphoric Mood, Activation, and Autistic Preoccupation. The combination of the 25 items produces a total score range of 25-175, and lower scores represent better outcomes.|Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10)|||total score||Standard Error|Mean
771654|NCT00728728|Secondary|The Calgary Depression Scale for Schizophrenia (CDSS)|The CDSS assesses the level of depression in schizophrenia by measuring nine items on a 0 (absent) to 3 (severe) scale each. Thus, the total score range is 0 to 27. Lower scores represent better outcomes.|Prospective, outcome measures collected over 10 week trial period.|||total score||Standard Error|Mean
771655|NCT00728728|Primary|Scale for the Assessment of Negative Symptoms(SANS)|The Scale for the Assessment of Negative Symptoms (SANS) is an assessment used to obtain clinical ratings of negative symptoms in patients with schizophrenia. The SANS assesses five symptom complexes. They are: affective blunting; alogia (impoverished thinking); avolition/apathy; anhedonia/asociality; and disturbance of attention. 24 assessments are conducted on a six-point scale (0=not at all to 5=severe) each, for a total scoring range of 0-120. Lower scores represent better performance.|Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10)|||total score||Standard Error|Mean
771656|NCT00728728|Primary|Brief Assessment of Cognition in Schizophrenia (BACS)|The Brief Assessment of Cognition in Schizophrenia (BACS) captures those domains of cognition that are the most severely affected in patients with schizophrenia and the most strongly correlated with functional outcome. The domains of cognitive function assessed and the associated tests include: Verbal Memory & Learning (Verbal Memory), Working Memory (Digit Sequencing), Motor Function (Token Motor Task), Verbal Fluency (Semantic and Letter Fluency), Speed of Processing (Symbol Coding), and Executive Function (Tower of London). These domains are then converted to Z scores compared to standardized scoring scales, with higher scores representing better performance.|Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10)|||Z score||Standard Error|Mean
771657|NCT00728728|Primary|University of California Performance-based Skills Assessment (UPSA)|The UCSD Performance-based Skills Assessment (UPSA) is a measure of Functional Capacity and assesses skills involved in community tasks. It is composed of five subdomains (comprehension and planning, finance, communication, mobility and house management) when combined, measures functional capacity. The comprehension and planning subdomain ranges from 0 to 14, the finance subdomain ranges from 0 to 11, the communication subdomain ranges from 0 to 12, the mobility subdomain ranges from 0 to 9, and the house management subdomain ranges from 0 to 4. Then a medication management score of 0 to 37 is added. In total, the Assessment is thus scored on a 0 to 87 scale, with higher scores indicating better performance.|Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10)|||total score||Standard Error|Mean
771658|NCT00728728|Primary|MATRICS Consensus Cognitive Battery (MCCB)|"The MATRICS Consensus Cognitive Battery (MCCB) is a standardized battery for use with adults with schizophrenia and related disorders to measure cognition in these individuals. The MCCB consists of ten individually administered test which measure speed of processing, attention/vigilance, nonverbal working memory, verbal working memory, verbal learning, visual learning, reasoning and problem solving and social cognition.
The primary raw scores are entered into the MCCB Computer Scoring Program which then generates the corresponding T-scores and percentiles, along with a graphic profile of the scores for each of the seven cognitive domains. Higher scores indicate better performance."|Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10)|||T score||Standard Error|Mean
771659|NCT00728754|Secondary|Osseous Integration||four years||||||
771660|NCT00728754|Primary|Crestal Bone Regression (Amount of Bone Measured) Around Each Implant Unit|Millimeters of crestal bone observed and measured in a radiograph of each study implant is measured and averaged to obtain the mean crestal bone loss or gain for each implant unit.|1 year|population analyzed was all patients receiving implants enrolled in the study, those reported here actually represent the number of implants being followed at the 12 month follow-up time point (time of analysis).||millimeters|implants|Standard Error|Mean
771661|NCT00728845|Secondary|Overall Survival (Phase II)||Treatment start date to date of death|Study was terminated early and insufficient data were collected to assess this outcome measure.|||||
771662|NCT00728845|Secondary|Progression-free Survival at 1 Year (Phase II)||Treatment start date to 1 year|Study was terminated early and insufficient data were collected to assess this outcome measure.|||||
771663|NCT00728845|Secondary|Time to Progression (Phase II)||Treatment start date and date of progression|Study was terminated early and insufficient data were collected to assess this outcome measure.|||||
771664|NCT00728845|Primary|Overall Response (Phase II)||Treatment start date to date of best response|Study was terminated early and insufficient data were collected to assess this outcome measure.|||||
771665|NCT00728845|Primary|Recommended Phase II Dose of Hydroxychloroquine and Carboplatin When Administered With Paclitaxel and Bevacizumab (Phase I)||Followed for the duration of the phase 1 treatment, an average of 18 weeks|Study was terminated early and insufficient data were collected to assess this outcome measure.|||||
771666|NCT00728884|Secondary|Crestal Bone Resorption||four years||12/2016||||
771667|NCT00728884|Primary|Osseous Integration||one year|total number of patients enrolled in the study were analyzed at this time (patients with implants not showing mobility).Patients receiving study implant(s) will achieve integration success (implant show no signs of mobility) of the implant at the time of analysis.||participants|||Number
771668|NCT00728910|Primary|Post-prandial Triglyceride Incremental Area Under the Curve (iAUC)|Triglyceride iAUC was measured during an oral fat tolerance test administered after 4 weeks of atorvastatin 10 mg/day , a further 8 weeks of atorvastatin 10mg /day+ABT335 135mg/day and then after a further 10 weeks of atorvastatin 10 mg/day+ABT335 135 mg/day+Niaspan 2000 mg/day. The standardized oral fat load was administered one hour post medication dosing and blood was collected prior to drug dosing, prior to the oral fat load and hourly thereafter for 10 hours (0,1,2,3,4,5,6,7,8,9,10,12 hrs post drug dosing)|4 weeks, 12 weeks, 22 weeks|subjects completing any phase of treatment for whom complete post-prandial data were available||mg/dl*h||95% Confidence Interval|Mean
771669|NCT00728910|Primary|Apo-A1 Production Rate|The apolipoprotein A-I production rate using (5,5,5-2H3-L-leucine) was measured following each of the three study periods i.e following 4 weeks of atorvastatin 10 mg/day, following 8 further weeks of ABT335 135 mg/day added to atorvastatin and following 10 further weeks of ER niacin 2000 mg/day and aspirin 325 mg/day added to atorvastatin+ABT335.|4 weeks, 12 weeks and 22 weeks|Patients who completed any phase of treatment for whom kinetic data were available||mg/kg/day||95% Confidence Interval|Mean
771670|NCT00728910|Primary|The Apolipoprotein A-I Fractional Catabolic Rate (FCR)|After receiving total daily caloric intake over 20 hrs as 20 identical small meals, starting at 0600 hrs, subjects took study medications at 0800 hrs. Five hours after the first meal, i.v. 5,5,5-2H3-L-leucine was administered, followed by a primed-constant infusion at 10 mol/kg body weight per hr for 15 hrs during which 14 blood samples were collected. Isotopic enrichment of leucine in apoA1 band excised from polyacrylamide gel was calculated. Assuming steady state apo A-I metabolism, we used a compartment model to fit data, consisting a precursor compartment (Compartment 1), the plasma leucine pool, an intracellular compartment accounting for apoA1 synthesis and lipoprotein assembly (Compartment 2), and compartments to account for dispositional kinetics of the subfractions including a plasma pool compartment (Compartment 3). The apoA1 FCR corresponds to the rate of irreversible loss of leucine pools from Compartment 3.|4 weeks, 12 weeks and 22 weeks|Patients who completed any of the three phases for whom the kinetic study data was available for any phase of treatment||pools/day||95% Confidence Interval|Mean
771671|NCT00728923|Secondary|Number of Patients That Met Response Criteria for the Hamilton Depression Rating Scale.|Patients given HAM-D (Hamilton Depression Scale), a measure of depressive symptoms. For the HAM-D the minimum units are 0 and Maximum units on the total scale are 50. The higher the number on the HAM-D, the more severe the symptoms. Response was defined as at least a 30% reduction on the HAM-D.|12 weeks|||participants|||Number
771672|NCT00728923|Primary|Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale|Patients given YBOCS (Yale Brown Obsessive-Compulsive Scale), a gold standard measure of obsessions and compulsions. For the YBOCS the minimum units are 0 and Maximum units on the total scale are 40. The higher the number on the YBOCS, the more severe the symptoms. Response was defined as at least a 30% reduction on the YBOCS.|12 weeks|||participants|||Number
771673|NCT00728962|Secondary|Crestal Bone Regression||four years||||||
771674|NCT00728962|Primary|Patients With Implants Achieving Osseous Integration|Patients receiving test implant(s) will achieve integration success (implant show no signs of mobility) of the implant at the time of analysis.|1 year|total number of patients enrolled in the study was used for primary outcome analysis||participants|||Number
771675|NCT00728988|Secondary|Percent Change From Baseline in C-Reactive Protein (CRP)|C-reactive protein percent change from baseline = (post baseline value minus baseline value) divided by baseline value*100. Includes all CRP samples tested for the study, including samples unaffected and those samples affected by defective high-sensitivity (hs) CRP reagents.|Baseline, 8 hours, 24 hours and 30 days|FAS. N = number of subjects with non-missing values at baseline.||percent change in CRP||Standard Error|Least Squares Mean
771676|NCT00728988|Secondary|Percentage of Participants With Elevated Myoglobin|Myoglobin above the upper limit of normal from baseline (biomarker of myocardial injury): normal range: 0-109 nanograms per milliliter (ng/mL).|8 hours, 24 hours and 30 days post PCI|FAS. N = number of participants with baseline and at least one post-baseline response.||percentage of participants|||Number
771677|NCT00728988|Secondary|Percentage of Participants With Elevated Troponin I|Troponin I above the upper limit of normal range from baseline (biomarker of myocardial injury): normal range: 0-0.5 nanograms per milliliter (ng/mL).|8 hours, 24 hours and 30 days post PCI|FAS. N = number of participants with baseline and at least one post-baseline response.||percentage of participants|||Number
771729|NCT00729469|Secondary|Change From Baseline to Week 4 in Percentage of Superficial Cells in the Maturation Index (Dyspareunia Strata)||4 weeks|ITT||percentage of superficial cells||Standard Deviation|Mean
771680|NCT00728988|Secondary|Percentage of Participants With Major Adverse Cardiac Events (MACE) (Incidence of MACE) at 8 Hours Post-PCI|Percentage calculated as: (number of participants who experienced MACE within 8 hours post-PCI) divided by (number of participants who experienced PCI) * 100.|8 hours post PCI|FAS.||percentage of participants|||Number
771681|NCT00728988|Primary|Percentage of Participants With Major Adverse Cardiac Events (MACE) (Incidence of MACE) at 30 Days Post-percutaneous Coronary Intervention (PCI)|Percentage calculated as: (number of participants who experienced MACE [death, myocardial infarction, target vessel revascularization] within 30 days post-PCI) divided by (number of participants who experienced PCI) * 100. Major Adverse Cardiac Events (MACE) that occurred after 33 days post PCI were excluded.|30 days post PCI|Full Analysis Set (FAS): all participants who received at least one dose of study medication and received percutaneous coronary intervention (PCI). Last observation carried forward (LOCF).||percentage of participants|||Number
771682|NCT00729157|Other Pre-specified|To Determine if Changes in Thyroglobulin Concentration After Four Cycles (Approximately 8 Weeks) of IV VEGF-Trap Therapy Correlate With Radiographic Response After Four Cycles (Approximately 8 Weeks)|This part is currently under data analysis, therefore, this outcome measure has not been calculated|8 weeks||||||
771683|NCT00729157|Other Pre-specified|To Determine if Pre-treatment Serum VEGF Concentration Correlates With Clinical Outcomes After IV VEGF Trap Therapy in Patients With Recurrent and/or Metastatic D-TC-FCO.|This part is currently under data analysis, therefore, this outcome measure has not been calculatedThis part is currently under data analysis, therefore, this outcome measure has not been calculated.|Baseline-6 months post treatment||||||
771684|NCT00729157|Secondary|Effect of Thyroglobulin Concentration on Progression-free Survival|The change is serum thyroglobulin was measured by the percent change between the baseline value and the lowest value obtained while on treatment.|6 months|||percent change serum thyroglobulin||Full Range|Median
771685|NCT00729157|Secondary|To Determine the Biologic Effect of IV VEGF Trap on FDG Avidity After Four Cycles (Approximately 8 Weeks) of Therapy Through Pre- and Post-treatment FDG-PET Scans in Patients With Recurrent and/or Metastatic D-TC-FCO.|To determine the biologic effect of IV VEGF Trap on FDG avidity after four cycles (approximately 8 weeks) of therapy through pre- and post-treatment FDG-PET scans in patients with recurrent and/or metastatic D-TC-FCO.|8 weeks|||percent of SUVm change||95% Confidence Interval|Median
771686|NCT00729157|Secondary|The Safety and Toxicity Profile of IV VEGF Trap in Patients With Recurrent and/or Metastatic TC-FCO|The number of participants, with recurrent and/or metastatic TC-FCO, who experienced adverse events. Please see the adverse event table for the specifics for this protocol.|From the beginning of treatment through 30 days until participant comes off study|||participants|||Number
771687|NCT00729157|Primary|Radiographic Response Rate of Aflibercept in Patients With Recurrent and/or Metastatic Thyroid Cancer That Did Not Respond to Radioactive Iodine Therapy|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions & assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + P RMeasurable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques (CT, MRI, x-ray) or as ≥ 10 mm with spiral CT scan. All tumor measurements must be recorded in millimeters (or decimal fractions of centimeters). All other lesions (or sites of disease), including small lesions (longest diameter < 20 mm with conventional techniques or < 10 mm using spiral CT scan), are considered non-measurable disease. Bone lesions, leptomeningeal disease, ascites, pleural/pericardial effusions, lymphangitis cutis/pulmonis, inflammatory breast disease, abdominal masses (not followed by CT or MRI), & cystic|After 8 weeks of study therapy|||participants|||Number
771688|NCT00729157|Primary|Progression-free Survival to Determine the 6-month Progression-free-survival (PFS) Rate|Progression-free survival to determine the 6-month progression-free-survival (PFS) rate|6 months|||months||95% Confidence Interval|Median
771689|NCT00729183|Secondary|Percent Change From Baseline in Serum N-Terminal Propeptides of Type 1 Collagen (s-P1NP) Level|s-P1NP is a biochemical marker index of bone formation. s-P1NP was measured via fasting blood draws at Baseline (Randomization), Month 6, Month 12, Month 18, and Month 24 for the repeated measures longitudinal ANCOVA model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as secondary outcome measures. s-P1NP was analyzed using the log-transformed fraction from baseline using the per-protocol approach. Data were back-transformed for presentation and geometric LS mean percent change from baseline was reported with 95% CI.|Baseline, 12 months, 24 months|PP population: All participants receiving at least one dose of study treatment and with available s-P1NP data, excluding participants with important deviations from the protocol that may have substantially affected the results.||percent change||95% Confidence Interval|Least Squares Mean
771690|NCT00729183|Secondary|Percent Change From Baseline in Serum C-Terminal Telopeptides of Type 1 Collagen (s-CTx) Level|s-CTx is a biochemical marker index of bone resorption. s-CTx was measured via fasting blood draws at Baseline (Randomization), Month 6, Month 12, Month 18, and Month 24 for the repeated measures longitudinal ANCOVA model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as secondary outcome measures. S-CTx was analyzed using the log-transformed fraction from baseline using the per-protocol approach. Data were back-transformed for presentation and geometric LS mean percent change from baseline was reported with 95% CI.|Baseline, 12 months, 24 months|Per-Protocol (PP) population: All participants receiving at least one dose of study treatment and with available s-CTx data, excluding participants with important deviations from the protocol that may have substantially affected the results.||percent change||95% Confidence Interval|Least Squares Mean
771691|NCT00729183|Secondary|Percent Change From Baseline in Trabecular vBMD at Central Section of Spine (L2)|Trabecular vBMD at the lumbar spine (L2) was measured by quantitative computed tomography (QCT). All QCT-derived vBMD measurements were evaluated centrally (and possibly locally) for bone and soft tissue abnormalities. Trabecular vBMD at the lumbar spine (L2) was assessed at the Screening visit (Baseline), Month 6, Month 12, and Month 24 for the repeated measures longitudinal ANCOVA model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as secondary outcome measures.|Baseline, 12 months, 24 months|FAS population: a subset of All Randomized Participants with participants receiving at least one dose of study treatment, having post-randomization QCT spine (L2) endpoint data subsequent to at least one dose of study treatment, and having QCT spine (L2) baseline data.||percent change||95% Confidence Interval|Least Squares Mean
771692|NCT00729183|Secondary|Percent Change From Baseline in Trabecular Volumetric Bone Mineral Density (vBMD) at Central Section of Spine (L1)|Trabecular vBMD at the lumbar spine (L1) was measured by quantitative computed tomography (QCT). All QCT-derived vBMD measurements were evaluated centrally (and possibly locally) for bone and soft tissue abnormalities. Trabecular vBMD at the lumbar spine (L1) was assessed at the Screening visit (Baseline), Month 6, Month 12, and Month 24 for the repeated measures longitudinal ANCOVA model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as secondary outcome measures.|Baseline, 12 months, 24 months|FAS population: a subset of All Randomized Participants with participants receiving at least one dose of study treatment, having post-randomization QCT spine (L1) endpoint data subsequent to at least one dose of study treatment, and having QCT spine (L1) baseline data.||percent change||95% Confidence Interval|Least Squares Mean
771693|NCT00729183|Secondary|Percent Change From Baseline in Distal Radius aBMD|aBMD (g/cm^2) data was measured by DXA at the one-third distal radius (forearm). aBMD data was centrally evaluated and all areal BMD measurements included a longitudinal BMD correction factor as determined by the quality control center. aBMD at the distal radius was assessed at the Screening visit (Baseline), Month 6, Month 12, and Month 24 for the repeated measures longitudinal ANCOVA model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as secondary outcome measures.|Baseline, 12 months, 24 months|FAS population: a subset of All Randomized Participants with participants receiving at least one dose of study treatment, having post-randomization distal radius aBMD endpoint data subsequent to at least one dose of study treatment, and having distal radius aBMD baseline data.||percent change||95% Confidence Interval|Least Squares Mean
771694|NCT00729183|Secondary|Percent Change From Baseline in Ultradistal Radius aBMD|aBMD (g/cm^2) data was measured by DXA at the ultradistal radius (forearm). aBMD data was centrally evaluated and all areal BMD measurements included a longitudinal BMD correction factor as determined by the quality control center. aBMD at the ultradistal radius was assessed at the Screening visit (Baseline), Month 6, Month 12, and Month 24 for the repeated measures longitudinal ANCOVA model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as secondary outcome measures.|Baseline, 12 months, 24 months|FAS population: a subset of All Randomized Participants with participants receiving at least one dose of study treatment, having post-randomization ultradistal radius aBMD endpoint data subsequent to at least one dose of study treatment, and having ultradistal radius aBMD baseline data.||percent change||95% Confidence Interval|Least Squares Mean
771695|NCT00729183|Secondary|Percent Change From Baseline in Total Radius aBMD|aBMD (g/cm^2) data was measured by DXA at the total radius (forearm). aBMD data was centrally evaluated and all areal BMD measurements included a longitudinal BMD correction factor as determined by the quality control center. aBMD at the total radius was assessed at the Screening visit (Baseline), Month 6, Month 12, and Month 24 for the repeated measures longitudinal ANCOVA model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as secondary outcome measures.|Baseline, 12 months, 24 months|FAS population: a subset of All Randomized Participants with participants receiving at least one dose of study treatment, having post-randomization total radius aBMD endpoint data subsequent to at least one dose of study treatment, and having total radius aBMD baseline data.||percent change||95% Confidence Interval|Least Squares Mean
771696|NCT00729183|Secondary|Percent Change From Baseline in Hip Trochanter aBMD|aBMD (g/cm^2) data was measured by DXA at the hip trochanter. All measurements utilized the same hip and at least 2 vertebrae for all time points. The left hip only was scanned. If the left hip was unevaluable, then the right hip was scanned. Once the appropriate leg was identified for scanning, it was used for all subsequent measurements. aBMD data was centrally evaluated and all areal BMD measurements included a longitudinal BMD correction factor as determined by the quality control center. aBMD at the hip trochanter was assessed at the Screening visit (Baseline), Month 6, Month 12, and Month 24 for the repeated measures longitudinal ANCOVA model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as secondary outcome measures.|Baseline, 12 months, 24 months|FAS population: a subset of All Randomized Participants with participants receiving at least one dose of study treatment, having post-randomization hip trochanter aBMD endpoint data subsequent to at least one dose of study treatment, and having hip trochanter aBMD baseline data.||percent change||95% Confidence Interval|Least Squares Mean
771697|NCT00729183|Secondary|Percent Change From Baseline in Femoral Neck aBMD|aBMD (g/cm^2) data was measured by DXA at the femoral neck (hip). All measurements utilized the same hip and at least 2 vertebrae for all time points. The left hip only was scanned. If the left hip was unevaluable, then the right hip was scanned. Once the appropriate leg was identified for scanning, it was used for all subsequent measurements. aBMD data was centrally evaluated and all areal BMD measurements included a longitudinal BMD correction factor as determined by the quality control center. aBMD at the femoral neck was assessed at the Screening visit (Baseline), Month 6, Month 12, and Month 24 for the repeated measures longitudinal ANCOVA model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as secondary outcome measures.|Baseline, 12 months, 24 months|FAS population: a subset of All Randomized Participants with participants receiving at least one dose of study treatment, having post-randomization femoral neck aBMD endpoint data subsequent to at least one dose of study treatment, and having femoral neck aBMD baseline data.||percent change||95% Confidence Interval|Least Squares Mean
771698|NCT00729183|Secondary|Percent Change From Baseline in Total Hip aBMD|aBMD (g/cm^2) data was measured by DXA at the total hip. All measurements utilized the same hip and at least 2 vertebrae for all time points. The left hip only was scanned. If the left hip was unevaluable, then the right hip was scanned. Once the appropriate leg was identified for scanning, it was used for all subsequent measurements. aBMD data was centrally evaluated and all areal BMD measurements included a longitudinal BMD correction factor as determined by the quality control center. aBMD at the total hip was assessed at the Screening visit (Baseline), Month 6, Month 12, and Month 24 for the repeated measures longitudinal ANCOVA model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as secondary outcome measures.|Baseline, 12 months, 24 months|FAS population: a subset of All Randomized Participants with participants receiving at least one dose of study treatment, having post-randomization total hip aBMD endpoint data subsequent to at least one dose of study treatment, and having total hip aBMD baseline data.||percent change||95% Confidence Interval|Least Squares Mean
771730|NCT00729469|Secondary|Change From Baseline to Week 4 in Percentage of Parabasal Cells in the Maturation Index (Dyspareunia Strata)||4 weeks|ITT||percentage of parabasal cells||Standard Deviation|Mean
771699|NCT00729183|Secondary|Percent Change From Baseline to Month 24 in Lumbar Spine aBMD|aBMD (g/cm^2) was measured by DXA at the lumbar spine and mean BMD measurements from at least 3 evaluable vertebrae from L1 through L4 were used. If a vertebra was fractured at baseline or became fractured during the study, its BMD measurement was excluded from the analysis and the lumbar spine BMD was recalculated based on the three remaining vertebrae. aBMD data was centrally evaluated and all areal BMD measurements included a longitudinal BMD correction factor as determined by the quality control center. aBMD at the lumbar spine was assessed at the Screening visit (Baseline), Month 6, Month 12, and Month 24 for the repeated measures longitudinal ANCOVA model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as primary and secondary outcome measures, respectively.|Baseline, 24 months|FAS population: a subset of All Randomized Participants with participants receiving at least one dose of study treatment, having Month 24 post-randomization lumbar spine aBMD endpoint data subsequent to at least one dose of study treatment, and having lumbar spine aBMD baseline data.||percent change||95% Confidence Interval|Least Squares Mean
771700|NCT00729183|Primary|Percentage of Participants That Discontinued Study Treatment Due to an AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR’s products, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR’s product was also an AE. The percentage of participants that discontinued study treatment (different from discontinuation of the study) due to an AE was reported for each treatment arm.|Up to ~14 days post study end (up to ~24 months)|APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.||percentage of participants|||Number
771701|NCT00729183|Primary|Percentage of Participants That Experienced an Adverse Event (AE)|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR’s products, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR’s product was also an AE. The percentage of participants that experienced at least one AE was reported for each treatment arm.|Up to ~14 days post study end (up to ~24 months)|All-Participants-as-Treated (APaT) population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.||percentage of participants|||Number
771702|NCT00729183|Primary|Percent Change From Baseline to Month 12 in Lumbar Spine Areal Bone Mineral Density (aBMD)|aBMD (g/cm^2) was measured by dual-energy X-ray absorptiometry (DXA) at the lumbar spine and mean BMD measurements from at least 3 evaluable lumbar spine vertebrae (L1-L4) were used. If a vertebra was fractured at baseline or became fractured during the study, its BMD measurement was excluded from the analysis and the lumbar spine BMD was recalculated based on the three remaining vertebrae. aBMD data was centrally evaluated and all areal BMD measurements included a longitudinal BMD correction factor as determined by the quality control center. aBMD at the lumbar spine was assessed at the Screening visit (Baseline), Month 6, Month 12, and Month 24 for the repeated measures longitudinal Analysis of Covariates (ANCOVA) model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as primary and secondary outcome measures, respectively.|Baseline, 12 months|Full-Analysis-Set (FAS) population: a subset of All Randomized Participants with participants receiving at least one dose of study treatment, having Month 12 post-randomization lumbar spine aBMD endpoint data subsequent to at least one dose of study treatment, and having lumbar spine aBMD baseline (BL) data.||percent change||95% Confidence Interval|Least Squares Mean
771703|NCT00729248|Primary|CD4+CD25 High FOXP3+ Cell Levels in Mixed Lymphocyte Reactions (MLRs) of Renal Pre-transplant Recipients/Donors|CD4+CD25 high FOXP3+ cell levels in mixed lymphocyte reactions (MLRs) of Renal Pre-transplant Recipients/Donors were measured in the presence of 1) No Drug/Control; 2) 0.05-0.2, 0.3-3 and > 5 ng/ml Tacrolimus (TAC); OR 3) 0.05-0.2, 0.3-3 and > 5 ng/ml Sirolimus (SRL). CD4+CD25 high FOXP3+ cell levels in the MLRs with TAC or SRL are expressed as the percentage of CD4+CD25 high FOXP3+ cell levels in the MLRs with no drug.|3 months|For each arm, blood samples from 5 donor/recipient pairs (i.e., 10 participants) were used.||Percentage of Control Cells||Standard Deviation|Mean
771704|NCT00729326|Secondary|Episodes of Hypoglycemia (Overall)|Number of episodes of hypoglycemia experienced overall during the study|4 weeks and 8 weeks|All patients in FAS||episodes of hypoglycemia|||Number
771705|NCT00729326|Secondary|Percentage of Patients Experiencing Hypoglycemia (Overall)|Percentage of patients experiencing minor hypoglycemia with a confirmed glucose <54mg/dL|4 weeks and 8 weeks|All patients in FAS||Percentage of patients|||Number
771706|NCT00729326|Secondary|Episodes of Hypoglycemia (Week 4 to Week 8)|Number of episodes of hypoglycemia experienced between week 4 and week 8 of the study|8 weeks|All patients in FAS||episodes of hypoglycemia|||Number
771707|NCT00729326|Secondary|Percentage of Patients Experiencing Hypoglycemia (Week 4 to Week 8)|Percentage of patients experiencing minor hypoglycemia with a confirmed glucose <54mg/dL|8 weeks|All patients in FAS||Percentage of patients|||Number
771708|NCT00729326|Secondary|Episodes of Hypoglycemia (Baseline to Week 4)|Number of episodes of hypoglycemia experienced during the first 4 weeks of the study|4 weeks|Full analysis set||episodes of hypoglycemia|||Number
771709|NCT00729326|Secondary|Percentage of Patients Experiencing Hypoglycemia (Baseline to Week 4)|Percentage of patients experiencing minor hypoglycemia with a confirmed glucose <54mg/dL|4 Weeks|All patients in FAS||Percentage of patients|||Number
771710|NCT00729326|Secondary|Change in Postprandial Active GLP-1 AUC Excursion After the Monrning Meal|Change in Postprandial active GLP-1 AUC excursion after the morning meal (t=0 to 4 hours) (i.e., postprandial active GLP-1 AUC excursion after the morning meal at baseline minus postprandial active GLP-1 AUC excursion after the morning meals at endpoint)|baseline and 8 Weeks|All patients in the FAS who have both baseline and endpoint measurements; Last Observation Carried Forward||pmol*hours/L||Standard Error|Least Squares Mean
771711|NCT00729326|Secondary|Change in Postprandial Active GLP-1 AUC After the Morning Meal|Change in Postprandial active GLP-1 AUC after the morning meal (t=0 to 4 hours) (i.e., postprandial active GLP-1 AUC after the morning meal at baseline minus postprandial active GLP-1 AUC after the morning meal at endpoint)|baseline and 8 Weeks|All patients in the FAS who have both baseline and endpoint measurements; Last Observation Carried Forward||pmol*hours/L||Standard Error|Least Squares Mean
771712|NCT00729326|Secondary|Change in Postprandial Insulin AUC Excursion After the Morning Meal|Change in Postprandial insulin AUC excursion after the morning meal (t=0 to 4 hours) (i.e., postprandial insulin AUC excursion after the morning meal at baseline minus postprandial insulin AUC excursion after the morning meal at endpoint)|baseline and 8 Weeks|All patients in the FAS who have both baseline and endpoint measurements; Last Observation Carried Forward||pmol*hours/L||Standard Error|Least Squares Mean
771713|NCT00729326|Secondary|Change in Postprandial Insulin AUC After the Morning Meal|Change in postprandial insulin AUC after the morning meal (t=0 to 4 hours) (i.e., postprandial insulin AUC after the morning meal at baseline minus postprandial insulin AUC after the morning meal at endpoint)|baseline and 8 Weeks|All patients in the FAS who have both baseline and endpoint measurements; Last Observation Carried Forward||pmol*hours/L||Standard Error|Least Squares Mean
771714|NCT00729326|Secondary|Change in Postprandial C-peptide AUC Excursion After the Morning Meal|Change in Postprandial C-peptide AUC excursion after the morning meal (t=0 to 4 hours) (i.e., postprandial C-peptide AUC excursion after the morning meal at baseline minus postprandial C-peptide AUC excursion after the morning meal at endpoint)|baseline and 8 Weeks|All patients in the FAS who have both baseline and endpoint measurements; Last Observation Carried Forward||nmol*hours/L||Standard Error|Least Squares Mean
771715|NCT00729326|Secondary|Change in Postprandial C-peptide AUC After the Morning Meal|Change in postprandial C-peptide AUC after the morning meal (t=0 to 4 hours) (i.e., postprandial C-peptide AUC after the morning meal at baseline minus postprandial C-peptide AUC after the morning meal at endpoint)|baseline and 8 Weeks|All patients in the FAS who have both baseline and endpoint measurements; Last Observation Carried Forward||nmol*hours/L||Standard Error|Least Squares Mean
771716|NCT00729326|Secondary|Change in Postprandial Triglyceride AUC Excursion After the Morning Meal|Change in postprandial triglyceride AUC excursion after the morning meal (t=0 to 4 hours) (i.e., postprandial triglyceride AUC excursion after the morning meal at baseline minus postprandial triglyceride AUC excursion after the morning meal at endpoint)|baseline and 8 Weeks|All patients in the FAS who have both baseline and endpoint measurements; Last Observation Carried Forward||mg*hours/dL||Standard Error|Least Squares Mean
771717|NCT00729326|Secondary|Change in Postprandial Triglyceride AUC After the Morning Meal|Change in postprandial triglyceride AUC after the morning meal (t=0 to 4 hours) (i.e., postprandial triglyceride AUC after the morning meal at baseline minus postprandial triglyceride AUC after the morning meal at endpoint)|baseline and 8 Weeks|All patients in the FAS who have both baseline and endpoint measurements; Last Observation Carried Forward||mg*hours/dL||Standard Error|Least Squares Mean
771718|NCT00729326|Secondary|Change in Postprandial Glucagon AUC Excursion After the Morning Meal|Change in postprandial glucagon AUC excursion after the morning meal (t=0 to 4 hours) (i.e., glucagon AUC excursion for 4 hours following the morning meal at baseline minus glucagon AUC excursion for 4 hours following the morning meal at endpoint)|baseline and 8 Weeks|All patients in the FAS who have both baseline and endpoint measurements; Last Observation Carried Forward||pmol*hours/L||Standard Error|Least Squares Mean
771719|NCT00729326|Secondary|Change in Postprandial Glucagon Area Under the Concentration-time Curve (AUC) After the Morning Meal|Change in Postprandial Glucagon AUC after the morning meal (t=0 to 4 hours) (i.e., Glucagon AUC over the first 4 hours following the morning meal at baseline minus glucagon AUC over the first 4 hours following the morning meal at endpoint)|baseline and 8 Weeks|All patients in the FAS who have both baseline and endpoint measurements; Last Observation Carried Forward||pmol*hours/L||Standard Error|Least Squares Mean
771720|NCT00729326|Secondary|Change in Fasting Blood Glucose After the Morning Meal|Change in fasting blood glucose after the morning meal from baseline to endpoint (i.e., fasting blood glucose after the morning meal at baseline minus fasting blood glucose after the morning meal at endpoint)|baseline and 8 Weeks|All patients in FAS who have both baseline and endpoint measurement; Last Observation Carried Forward||mg/dL||Standard Error|Least Squares Mean
771721|NCT00729326|Secondary|Change in Two-hour Postprandial Glucose After the Morning Meal|Change in 2 hour post-prandial glucose after the morning meal from baseline to endpoint (i.e., glucose level 2 hours after the morning meal at baseline minus glucose level 2 hours after the morning meal at endpoint)|baseline and 8 Weeks|All patients in FAS who have both baseline and endpoint measurement; Last Observation Carried Forward||mg/dL||Standard Error|Least Squares Mean
771722|NCT00729326|Primary|Change in Time-averaged Glucose During a 24 Hour Period|Change in time-averaged glucose during a 24-hour period from baseline to endpoint (i.e., time-averaged glucose over 24 hours at endpoint minus time-averaged glucose over 24 hours at baseline).|baseline and 8 Weeks|The number of patients was determined based on 90% powering of the study. Analyses were based on data from all randomized patients receiving at least one dose of the study drug and completing at least one treatment period. For each patient, the missing data for some time points were imputed by linear interpolation.||mg/dL||Standard Error|Least Squares Mean
771723|NCT00729365|Secondary|We Will Assess Changes in the Relative Stiffness of Your Arteries (Endothelial Dysfunction) in Persons With Type 1 Diabetes Over the 5year Study.||year 1, 3, 5 and after the washout phase (5years and 1month)||||||
771724|NCT00729365|Primary|Development of Microalbuminuria (High Urine Albumin). Hypertension, Urine and Blood Markers Will Also be Evaluated for Assessment of Kidney Disease State.||at 3months and then every 6months during the 5years of the study||||||
771725|NCT00729430|Secondary|Effect of Omega-3 Fatty Acids on Infarct Size|Measured as change in infarct size from baseline to post-treatment (6-months)|Measured in the 3-year follow-up period after participant's last study visit|||Percent Change||Standard Deviation|Mean
771726|NCT00729430|Secondary|Effect of Omega-3 Fatty Acids on Left Ventricular Ejection Fraction|Measured as change in left ventricular ejection fraction from baseline to post-treatment (6-months)|Measured in the 3-year follow-up period after participant's last study visit|||Percent Change||Standard Deviation|Mean
771727|NCT00729430|Secondary|Effect of Omega-3 Fatty Acids on Non-Infarct Myocardial Fibrosis|Measured as change in myocardial extracellular volume fraction of non-infarcted myocardium from baseline to post-treatment (6-months)|Measured in the 3-year follow-up period after participant's last study visit|||Percent Change||Standard Deviation|Mean
771728|NCT00729430|Primary|Effect of Omega-3 Fatty Acids on Adverse Left Ventricular Remodeling|Measured as change in left ventricular end-systolic volume indexed to body surface area from baseline to post-treatment (6-months)|Before and after study treatments|||Percent Change||Standard Deviation|Mean
771731|NCT00729469|Secondary|Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata)||4 weeks|ITT; change from baseline to week 4 in severity of most bothersome symptom of vaginal pain associated with sexual activity (dyspareunia strata) was assessed in 287 subjects in the placebo group and 295 subjects in the ospemifene 60 mg/day group.||participants|||Number
771732|NCT00729469|Secondary|Change From Baseline to Week 4 in Vaginal pH (Dyspareunia Strata)||4 weeks|ITT||pH||Standard Deviation|Mean
771733|NCT00729469|Secondary|Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata)||4 weeks|ITT; change from baseline to week 4 in severity of most bothersome symptom of vaginal dryness associated with sexual activity (dryness strata) was assessed in 152 subjects in the placebo group and 154 subjects in the ospemifene 60 mg/day group.||participants|||Number
771734|NCT00729469|Secondary|Change From Baseline to Week 4 in Vaginal pH (Dryness Strata)||4 weeks|ITT||pH||Standard Deviation|Mean
771735|NCT00729469|Primary|Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata)||12 weeks|ITT; LOCF||participants|||Number
771736|NCT00729469|Primary|Change From Baseline to Week 12 in Vaginal pH (Dyspareunia Strata)||12 weeks|ITT; LOCF||pH||Standard Deviation|Mean
771737|NCT00729469|Primary|Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smears (Dyspareunia Strata)||12 weeks|ITT; LOCF||percentage of superficial cells||Standard Deviation|Mean
771738|NCT00729469|Primary|Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear (Dyspareunia Strata)||12 weeks|ITT; LOCF||percentage of parabasal cells||Standard Deviation|Mean
771739|NCT00729469|Primary|Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata)||12 weeks|ITT; LOCF||participants|||Number
771740|NCT00729469|Secondary|Change From Baseline to Week 4 in Percentage of Superficial Cells in the Maturation Index (Dryness Strata)||4 weeks|ITT||percentage of superficial cells||Standard Deviation|Mean
771741|NCT00729469|Secondary|Change From Baseline to Week 4 in Percentage of Parabasal Cells in the Maturation Index (Dryness Strata)||4 weeks|ITT||percentage of parabasal cells||Standard Deviation|Mean
771742|NCT00729469|Primary|Change From Baseline to Week 12 in Vaginal pH (Dryness Strata)||12 weeks|ITT; LOCF||pH||Standard Deviation|Mean
771743|NCT00729469|Primary|Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smears (Dryness Strata)||12 weeks|ITT; LOCF||percentage of superficial cells||Standard Deviation|Mean
771744|NCT00729469|Primary|Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear (Dryness Strata)||12 weeks|ITT; LOCF||percentage of parabasal cells||Standard Deviation|Mean
771745|NCT00729482|Secondary|Toxicity Profiles (According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0)||up to 24 weeks|||participants|||Number
771746|NCT00729482|Secondary|Overall Survival||1 year|||Months||95% Confidence Interval|Median
771747|NCT00729482|Secondary|Response Rate||2years|51 patients were available for response assessments.||percentage of participants|||Number
771748|NCT00729482|Primary|Progression-free Survival Rate at 4-month (16 Weeks)||4 months (16 weeks)|||percentage of participants|||Number
771749|NCT00729521|Primary|Emergency Department and In-patient Hospitalization for Fall Injury|Rates of fall injury diagnoses per 100 person-years (P-Y) were computed for the communities in each of the study groups for a 2 year baseline period, 2007-2008, and for a 2 year follow-up period corresponding to years 2010-2011. Change in fall injury rates and their 95% confidence intervals (CI) are reported. A mixed-effects Poisson regression model was used to test the presence of an interaction effect on the fall rate between study group and time period (baseline or follow-up). The test is intended to detect a differential time effect by study group. This model, with main effects for study group and time period and an interaction term, will be referred to as the primary model. Model coefficients and incidence rate ratios (IRR) with 95% confidence intervals (CI) are reported.|2007-2008; 2010-2011|Population of residents aged 65 and older for participating communities in each study arm for 2007-2008 baseline period and 2010-2011 follow-up period.||Fall Injury Rate per 100 person years||95% Confidence Interval|Number
771750|NCT00729560|Primary|DCI-IPG Measurements in Blood and Urine|zero participants analyzed, no assays performed|2 years||||||
771751|NCT00729612|Secondary|Incidence and Intensity of Adverse Events Graded According to NCI CTCAE v. 3.0|The incidence and intensity of adverse events graded according to NCI CTCAE v. 3.0 will be evaluated using descriptive statistics|Up to 5 years|Grade 3 and 4||patients|||Number
771752|NCT00729612|Secondary|Overall Survival|Will be analyzed using a Kaplan-Meier methods.|Up to 5 years|||months||95% Confidence Interval|Median
771753|NCT00729612|Secondary|Progression Free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Up to 5 years|||months||95% Confidence Interval|Median
771754|NCT00729612|Primary|Overall Response Rate Defined as Complete or Partial Response as Assessed by RECIST Version 1.0 Criteria.|Response rate is overall response rate (CR+PR) as defined by RECIST criteriaPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 5 years|||percentage of patients||95% Confidence Interval|Number
771755|NCT00729651|Post-Hoc|Mean Serum 25 OHD(Serum 25-hydroxyvitamin D) at 16 Weeks of Treatment||16 weeks|Participants for analysis was modified intention to treat (Number of patients : Fosamax Plus D Group was 136, Fosamax was 132). Missing data were imputed by the last observation carried forward (LOCF) technique.||ng/ml||Standard Deviation|Mean
771756|NCT00729651|Post-Hoc|Patients With Serum 25 OHD (Serum 25-hydroxyvitamin D) Less and Greater Than 20 ng/ml at 16 Weeks of Treatment||16 weeks|Participants for analysis was modified intention to treat (Number of patients : Fosamax Plus D Group was 136, Fosamax was 132). Missing data were imputed by the last observation carried forward (LOCF) technique.||participants|||Number
771757|NCT00729651|Secondary|Serum PTH (Parathyroid Hormone) Percentage Changes From Baseline to 16 Weeks of Treatment||Baseline and 16 weeks|Participants for analysis was modified intention to treat (Number of patients : Fosamax Plus D Group was 136, Fosamax was 132). Missing data were imputed by the last observation carried forward (LOCF) technique.||Percentage Change Serum PTH||95% Confidence Interval|Least Squares Mean
771758|NCT00729651|Primary|Patients With Serum 25 OHD (Serum 25-hydroxyvitamin D) Below the Deficiency Level (Less Than 15 ng/ml) at 16 Weeks of Treatment||16 weeks|Participants for analysis was modified intention to treat (Number of patients : Fosamax Plus D Group was 136, Fosamax was 132). Missing data were imputed by the last observation carried forward (LOCF) technique.||participants|||Number
771759|NCT00729677|Post-Hoc|Number of Participants by Antiemetic Regimen Who Reported Nausea During First Cycle of Chemotherapy|Number of participants on 2-drug (5HT3 inhibitor plus steroid) versus 3 drug (2-drug regimen plus an NK-1 inhibitor) who reported nausea during the first cycle of chemotherapy. 5HT-3 inhibitors included ondansetron, dolasetron, granisetron, and palonosetron. The NK-1 inhibitor was aprepitant. The steroid was dexamethasone.|Week 1|||participants|||Number
771760|NCT00729677|Primary|Number of Participants by History of Nausea Who Reported Nausea During the First Week of Chemotherapy|Number of participants with factors associated with increased frequency of nausea in the first cycle of chemotherapy, including history of motion sickness, history of pregnancy-related morning sickness, history of prior chemotherapy, and history of nausea associated with prior chemotherapy|week 1|||participants|||Number
771761|NCT00729677|Primary|Impact of Nausea and Vomiting on the Patient's Quality of Life as Measured by the Functional Living Index – Emesis Scale at 5-7 Days|Scale describing impact of nausea and vomiting on quality of life on a seven-point Likert Scale with higher score indicating worse quality of life.|Week 1|this data was not collected|||||
771762|NCT00729677|Primary|Percentages of Participants by Gender Who Reported Nausea During the First Week of Chemotherapy||Week 1 of FOLFOX chemotherapy|||percentage of participants|||Number
771763|NCT00729690|Secondary|Passive Knee Flexion|Passive flexion is the moment of the joint with the assistance of a clinician (The clinician or therapist physically hold and moves the knee through it's range of motion).|PostOp day 2|All Completed Patients were used||Degrees||Standard Deviation|Mean
771764|NCT00729690|Primary|NRS Pain Score AUC (NRS*hr) - 1st 12 Hours|Numerical Response scale NRS(0-10) Pain scores were collected every 4 hours after the initial dose and the Area Under the Curve (AUC) calculated. Calculated for the 1st 12 hours after initial dose (0-12hr). AUC measured in NRS pain score points per hour (NRS*hr). Larger AUC values indicate higher levels of reported pain.|12 hours Post dose|All Completed Patients||Area (NRS*hr)||Standard Deviation|Mean
771765|NCT00729690|Secondary|Active Knee Flexion|The degree of active knee flexion (ROM) tolerated by the patient will be assessed at days 1 and 2 post-surgery. Active flexion is the unassisted moment of the joint by the subject. On postoperative (PostOp) day 2|PostOp day 2|All completed patients used.||Degrees||Standard Deviation|Mean
771766|NCT00729690|Primary|NRS Pain Score AUC (NRS*hr) - 1st 24 Hours|Numerical Response scale NRS(0-10) Pain scores were collected every 4 hours after the initial dose and the Area Under the Curve (AUC) calculated. Calculated for the 1st 24 hours after initial dose (0-24hr). AUC measured in NRS pain score points per hour (NRS*hr). Larger AUC values indicate higher levels of reported pain.|24 hours|All Completed Patients were included in the analysis.||Area (NRS*hr)||Standard Deviation|Mean
771767|NCT00721578|Secondary|Medication Administration|Participants who received medication by IV or oral administration, reported by total number of participants receiving IV and total number of participants receiving oral administation (overall), and by total number of participants receiving voriconazole only by IV or oral administration.|Up to 9 months|FAS.||Participants|||Number
771768|NCT00721578|Secondary|Median Duration of Antifungal Therapy||Up to 9 months|FAS.||Days||Full Range|Median
771769|NCT00721578|Secondary|Concomitant Medications||Up to 9 months|FAS.||Participants|||Number
771770|NCT00721578|Primary|Number of Participants With Mycological Outcomes|"Mycological outcome of persistence (continued presence of fungi on microbiology despite therapy), eradication (absence of fungi after therapy
), or unknown (results are not available/not known) as assessed by the Investigator/Physician."|Up to 9 months|FAS.||Participants|||Number
771771|NCT00721578|Primary|Number of Participants With Clinical Outcomes.|"Clinical outcomes, as assessed by the investigator, defined as:
Cured: clinical signs and symptoms of fungal infection absent. Improved: clinical signs and symptoms of fungal infection improved. Stable: no change in overall clinical findings, compared with previous reporting period.
Deteriorated: clinical signs and symptoms of fungal infection worsened (including death).
Indeterminate; clinical signs and symptoms of fungal infection were insufficient to make an evaluation."|Up to 9 months|FAS.||Participants|||Number
771772|NCT00721578|Primary|Total Daily Dose for Selected Antifungal Agent||Up to 9 months|FAS. Data were not analyzed.||mg|||Number
771773|NCT00721578|Primary|Management of SFI: Reason for Selection of Antifungal Agent|Number of participants with reason for investigator's selection of particular antifungal therapy.|Up to 9 months|FAS. Data were not analyzed.||Participants|||Number
771774|NCT00721578|Primary|Management of SFI: Choice of Treatment|Number of participants treated with each antifungal therapy. Each participant may have recieved 1 or more treatments as deemed clinically necessary by the investigator.|Up to 9 months|FAS.||Participants|||Number
771775|NCT00721578|Primary|Diagnosis of Systemic Fungal Infection (SFI)|Evidence of clinical signs and symptoms of systemic fungal infection including: fever, hypotension, or radiological or microbiological evidence, as assessed by the investigator.|Up to 9 months|Full analysis set (FAS) = all enrolled participants who received at least one dose of antifungal therapy. n = number of participants who had microbiological assessments performed. SOT = start of treatment, EOT = end of treatment||Participants|||Number
771785|NCT00721617|Secondary|Plasma Glucose Levels for Dextrose Infusion|Blood samples were collected for measurement of plasma glucose levels at baseline, 4 hours after dextrose infusion, and 8 hours after dextrose infusion. Plasma glucose was measured on CX7 Chemistry Analyzer. Current guidelines identify normal fasting glucose as less than 100 mg/dL. High levels of glucose most frequently indicates diabetes.|Baseline, 4 hours, 8 hours|||mg/dL||Standard Deviation|Mean
771830|NCT00729859|Primary|Endothelial Progenitor Cells|Number of CD33 + CD134+ cells as a percentage of all lymphocytes|Baseline, Day 28|Statistical analyses were limited to changes from baseline within a given group and between-group comparisons were not performed||percentage of all lymphocytes||Standard Deviation|Mean
771776|NCT00721617|Secondary|C-peptides Levels for Intralipid/Dextrose Infusion|"Blood samples were collected for the measurement of C-peptide levels at baseline, 4 hours after intralipid/dextrose infusion, and 8 hours after intralipid/dextrose infusion. C-peptide was measured in plasma using a solid phase, two-site sequential chemiluminescent immunometric assays on the DPC Immulite analyzer. Current guidelines identify normal C-peptide levels as 0.51 to 2.72 ng/mL.
A high level of C-peptide generally indicates a high level of endogenous insulin production. This may be in response to a high blood glucose caused by glucose intake and/or insulin resistance. A high level of C-peptide is also seen with insulinomas and may be seen with low blood potassium, Cushing syndrome, and renal failure. A low level of C-peptide is associated with a low level of insulin production. This can occur when insufficient insulin is being produced by the beta cells, with diabetes for example, or when production is suppressed by treatment with exogenous insulin."|Baseline, 4 hours, 8 hours|||ng/mL||Standard Deviation|Mean
771777|NCT00721617|Secondary|C-peptides Levels for Dextrose Infusion|"Blood samples were collected for the measurement of C-peptide levels at baseline, 4 hours after dextrose infusion, and 8 hours after dextrose infusion. C-peptide was measured in plasma using a solid phase, two-site sequential chemiluminescent immunometric assays on the DPC Immulite analyzer. Current guidelines identify normal C-peptide levels as 0.51 to 2.72 ng/mL.
A high level of C-peptide generally indicates a high level of endogenous insulin production. This may be in response to a high blood glucose caused by glucose intake and/or insulin resistance. A high level of C-peptide is also seen with insulinomas and may be seen with low blood potassium, Cushing syndrome, and renal failure. A low level of C-peptide is associated with a low level of insulin production. This can occur when insufficient insulin is being produced by the beta cells, with diabetes for example, or when production is suppressed by treatment with exogenous insulin."|Baseline, 4 hours, 8 hours|||ng/mL||Standard Deviation|Mean
771778|NCT00721617|Secondary|C-peptides Levels for Intralipid Infusion|"Blood samples were collected for the measurement of C-peptide levels at baseline, 4 hours after Intralipid infusion, and 8 hours after Intralipid infusion. C-peptide was measured in plasma using a solid phase, two-site sequential chemiluminescent immunometric assays on the DPC Immulite analyzer. Current guidelines identify normal C-peptide levels as 0.51 to 2.72 ng/mL.
A high level of C-peptide generally indicates a high level of endogenous insulin production. This may be in response to a high blood glucose caused by glucose intake and/or insulin resistance. A high level of C-peptide is also seen with insulinomas and may be seen with low blood potassium, Cushing syndrome, and renal failure. A low level of C-peptide is associated with a low level of insulin production. This can occur when insufficient insulin is being produced by the beta cells, with diabetes for example, or when production is suppressed by treatment with exogenous insulin."|Baseline, 4 hours, 8 hours|||ng/mL||Standard Deviation|Mean
771779|NCT00721617|Secondary|C-peptides Levels for Saline Infusion|"Blood samples were collected for the measurement of C-peptide levels at baseline, 4 hours after saline infusion, and 8 hours after saline infusion. C-peptide was measured in plasma using a solid phase, two-site sequential chemiluminescent immunometric assays on the DPC Immulite analyzer. Current guidelines identify normal C-peptide levels as 0.51 to 2.72 ng/mL.
A high level of C-peptide generally indicates a high level of endogenous insulin production. This may be in response to a high blood glucose caused by glucose intake and/or insulin resistance. A high level of C-peptide is also seen with insulinomas and may be seen with low blood potassium, Cushing syndrome, and renal failure. A low level of C-peptide is associated with a low level of insulin production. This can occur when insufficient insulin is being produced by the beta cells, with diabetes for example, or when production is suppressed by treatment with exogenous insulin."|Baseline, 4 hours, 8 hours|||ng/mL||Standard Deviation|Mean
771780|NCT00721617|Secondary|Insulin Levels for Intralipid/Dextrose Infusion|Blood samples were collected for the measurement of insulin levels at baseline, 4 hours after intralipid/dextrose infusion, and 8 hours after intralipid/dextrose infusion. Insulin was measured in plasma using a solid phase, two-site sequential chemiluminescent immunometric assays on the DPC Immulite analyzer. Current guidelines identify normal insulin levels as 8.8 μU/mL for men and 8.4 for women. High levels of insulin most frequently indicate insulin resistance or hypoglycemia, if paired with a low glucose level. Low levels of insulin paired with high glucose level can indicate diabetes.|Baseline, 4 hours, 8 hours|||μU/mL||Standard Deviation|Mean
771781|NCT00721617|Secondary|Insulin Levels for Dextrose Infusion|Blood samples were collected for the measurement of insulin levels at baseline, 4 hours after dextrose infusion, and 8 hours after dextrose infusion. Insulin was measured in plasma using a solid phase, two-site sequential chemiluminescent immunometric assays on the DPC Immulite analyzer. Current guidelines identify normal insulin levels as 8.8 μU/mL for men and 8.4 for women. High levels of insulin most frequently indicate insulin resistance or hypoglycemia, if paired with a low glucose level. Low levels of insulin paired with high glucose level can indicate diabetes.|Baseline, 4 hours, 8 hours|||μU/mL||Standard Deviation|Mean
771782|NCT00721617|Secondary|Insulin Levels for Intralipid Infusion|Blood samples were collected for the measurement of insulin levels at baseline, 4 hours after intralipid infusion, and 8 hours after intralipid infusion. Insulin was measured in plasma using a solid phase, two-site sequential chemiluminescent immunometric assays on the DPC Immulite analyzer. Current guidelines identify normal insulin levels as 8.8 μU/mL for men and 8.4 for women. High levels of insulin most frequently indicate insulin resistance or hypoglycemia, if paired with a low glucose level. Low levels of insulin paired with high glucose level can indicate diabetes.|Baseline, 4 hours, 8 hours|||μU/mL||Standard Deviation|Mean
771783|NCT00721617|Secondary|Insulin Levels for Saline Infusion|Blood samples were collected for the measurement of insulin levels at baseline, 4 hours after saline infusion, and 8 hours after saline infusion. Insulin was measured in plasma using a solid phase, two-site sequential chemiluminescent immunometric assays on the DPC Immulite analyzer. Current guidelines identify normal insulin levels as 8.8 μU/mL for men and 8.4 for women. High levels of insulin most frequently indicate insulin resistance or hypoglycemia, if paired with a low glucose level. Low levels of insulin paired with high glucose level can indicate diabetes.|Baseline, 4 hours, 8 hours|||μU/mL||Standard Deviation|Mean
771784|NCT00721617|Secondary|Plasma Glucose Levels for Intralipid/Dextrose Infusion|Blood samples were collected for measurement of plasma glucose levels at baseline, 4 hours after intralipid/dextrose infusion, and 8 hours after intralipid/dextrose infusion. Plasma glucose was measured on CX7 Chemistry Analyzer. Current guidelines identify normal fasting glucose as less than 100 mg/dL. High levels of glucose most frequently indicates diabetes.|Baseline, 4 hours, 8 hours|||mg/dL||Standard Deviation|Mean
771786|NCT00721617|Primary|Change in Diastolic Blood Pressure From Baseline to 8 Hours|Diastolic blood pressure is the amount of pressure in your arteries when your heart is at rest between beats. Current guidelines identify normal diastolic blood pressure as lower than 80 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 8 hour infusion with subjects in supine position. Change is the difference between 8 hour diastolic blood pressure from baseline diastolic blood pressure.|Baseline, 8 hours|||mmHg||Standard Deviation|Mean
771787|NCT00721617|Primary|Change in Diastolic Blood Pressure From Baseline to 4 Hours|Diastolic blood pressure is the amount of pressure in your arteries when your heart is at rest between beats. Current guidelines identify normal diastolic blood pressure as lower than 80 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 8 hour infusion with subjects in supine position. Change is the difference between 4 hour diastolic blood pressure from baseline diastolic blood pressure.|Baseline, 4 hours|||mmHg||Standard Deviation|Mean
771788|NCT00721617|Secondary|Plasma Glucose Levels for Intralipid Infusion|Blood samples were collected for measurement of plasma glucose levels at baseline, 4 hours after intralipid infusion, and 8 hours after intralipid infusion. Plasma glucose was measured on CX7 Chemistry Analyzer. Current guidelines identify normal fasting glucose as less than 100 mg/dL. High levels of glucose most frequently indicates diabetes.|Baseline, 4 hours, 8 hours|||mg/dL||Standard Deviation|Mean
771789|NCT00721617|Secondary|Plasma Glucose Levels for Saline Infusion|Blood samples were collected for measurement of plasma glucose levels at baseline, 4 hours after saline infusion, and 8 hours after saline infusion. Plasma glucose was measured on CX7 Chemistry Analyzer. Current guidelines identify normal fasting glucose as less than 100 mg/dL. High levels of glucose most frequently indicates diabetes.|Baseline, 4 hours, 8 hours|||mg/dL||Standard Deviation|Mean
771790|NCT00721617|Secondary|Change in Triglyceride Levels From Baseline to 8 Hours|Blood samples were collected for measurement of triglycerides at baseline and 4 hours after each infusion. Triglyceride levels were measured on CX7 Chemistry Analyzer. Current guidelines identify normal range of triglyceride level as less than 150 mg/dL. Elevated levels of triglycerides are associated with an increased risk of developing heart disease. Change is the difference between 8 hour triglyceride levels from baseline triglyceride levels.|Baseline, 8 hours|||mg/dL||Standard Deviation|Mean
771791|NCT00721617|Secondary|Change in Triglyceride Levels From Baseline to 4 Hours|Blood samples were collected for measurement of triglycerides at baseline and 4 hours after each infusion. Triglyceride levels were measured on CX7 Chemistry Analyzer. Current guidelines identify normal range of triglyceride level as less than 150 mg/dL. Elevated levels of triglycerides are associated with an increased risk of developing heart disease. Change is the difference between 4 hour triglyceride levels from baseline triglyceride levels.|Baseline, 4 hours|||mg/dL||Standard Error|Mean
771792|NCT00721617|Secondary|Changes in FFA (Free Fatty Acid) Levels From Baseline to 8 Hours|Blood samples were collected for measurement of free fatty acids (FFA) at baseline and 8 hours after each infusion. FFA levels were determined by colorimetric method. Current guidelines identify normal range of FFA level as less than 0.72 mmol/L. Elevated plasma levels of FFA indicate a greater rate of insulin resistance. Change iis the difference between 8 hour FFA levels from baseline FFA levels.|Baseline, 8 hours|||mmol/L||Standard Deviation|Mean
771793|NCT00721617|Secondary|Change in FFA (Free Fatty Acid) Levels From Baseline to 4 Hours|Blood samples were collected for measurement of free fatty acids (FFA) at baseline and 4 hours after each infusion. FFA levels were determined by colorimetric method. Current guidelines identify normal range of FFA level as less than 0.72 mmol/L. Elevated plasma levels of FFA indicate a greater rate of insulin resistance. Change is the difference between 4 hour FFA levels from baseline FFA levels.|Baseline, 4 hours|||mmol/L||Standard Deviation|Mean
771794|NCT00721617|Primary|Change in Systolic Blood Pressure From Baseline to 8 Hours|Systolic blood pressure is the amount of pressure your heart generates when pumping blood through your arteries to the rest of your body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 8 hour infusion with subjects in supine position. Change is the difference between 8 hour systolic blood pressure from baseline systolic blood pressure.|Baseline, 8 hours|||mmHg||Standard Error|Mean
771795|NCT00721617|Primary|Change in Systolic Blood Pressure From Baseline to 4 Hours|Systolic blood pressure is the amount of pressure the heart generates when pumping blood through the arteries to the body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 8 hour infusion with subjects in supine position. Change is the difference between 4 hour systolic blood pressure from baseline systolic blood pressure.|Baseline, 4 hours|||mmHg||Standard Error|Mean
771796|NCT00721617|Primary|Change in Flow-mediated Dilation From Baseline to 4 Hours|Endothelium-dependent brachial artery flow-mediated dilation (FMD) was assessed. Ultrasound images of the brachial artery were obtained and arterial diameters were measured with customized software. FMD is expressed as the change in diameter from baseline to 4 hours.|Baseline, 4 hours|||percent change in diameter||Standard Deviation|Mean
771797|NCT00729781|Primary|Safety|Evaluate complications and adverse events. Events are presented descriptively with no statistical analysis.|During 12-week original study and at long-term follow-up of 11 months or longer|All enrolled subjects' adverse events were collected.||events|||Number
771798|NCT00729781|Primary|Cosmetic Improvement|"An independent clinician will review Vectra 3D photographs of each subject at baseline and at 12 weeks post-procedure to assess physical appearance of the external nasal wall. The clinician will be asked to determine which photographs are pre-treatment and which are post-treatment in the correct order. The clinician will then rate the photograph chosen as post-treatment using the Global Aesthetic Improvement Scale (GAIS; relative scale from Worse to Very much improved). If the post-treatment photograph was not correctly identified, that procedure will receive a “worse” on the rating scale."|12 weeks after implantation|An implanted subject with missing data at 12 weeks of follow-up had the 6-week data carried forward to 12 weeks for analysis. If the 6-week data was unavailable, the subject's treatment was considered a failure.||participants|||Number
771811|NCT00729833|Secondary|Maximum Observed Plasma Concentration (Cmax) of Sunitinib||0.5 hour predose and 2, 4, 6, 8, 12, and 24 hours postdose on Day 15 of Cycle 1|PK Analysis Set: Participants who received all scheduled doses of both drugs and completed all required PK assessments in the dose expansion cohort (figitumumab 10 mg/kg + sunitinib 25 mg CDD).||nanogram/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
771799|NCT00729781|Primary|Functional Improvement|"Functional improvement was defined as a subject who achieves both 1) an improvement in the physical condition of the collapsed nasal valve as evidenced by an increase of >= 10% in the change in volume during inspiration as measured by Vectra 3D photography from baseline to 12 weeks post-procedure; and 2) a reduction of at least 30% in the symptoms of nasal obstruction as measured by the Nasal Obstruction Symptom Evaluation Scale (NOSE) scale (5 questions with 0-4 scale from Not a problem to Severe problem, possible score 0-100 via raw score × 5) from baseline to 12 weeks post-procedure."|12 weeks after implantation|An implanted subject with missing data at 12 weeks of follow-up had the 6-week data carried forward to 12 weeks for analysis. If the 6-week data was unavailable, the subject's treatment was considered a failure.||participants|||Number
771800|NCT00729807|Secondary|Progression Time in Patients|To observe the time to progression in these patients. However, in the six patients treated they either all had progression of disease or stable when they came off study (i.e., the drug did not work, there was no basis to collect the data to time to progression (they went on to different treatments or hospice.) One patient was inevaluable due to going on hospice, four had disease progression disease and one had stable disease and patients must come off per protocol if they do not show a response to the drug.|pre- to post-treatment||04/2017||||
771801|NCT00729807|Secondary|Pre- and Post-treatment Changes in the Concentration of S100B and p21 in Tumor Biopsy Samples|Zero participants analyzed. Data was not analyzed owing to the small number of patients actually treated with pentamidine; most patients screened could not enter owing to inability to define p53 status in a timely fashion and emergence of immunotherapeutics as an active modality in melanoma. Data Safety Monitoring board recommended closure to accrual after documentation of hypotension and hypoglycemia in the small cohort of patients actuallyly treated.|pre- and pos-treatment||04/2017||||
771802|NCT00729807|Secondary|Serial Serum S100B Levels|Zero participants analyzed. Data was not analyzed owing to the small number of patients actually treated with pentamidine; most patients screened could not enter owing to inability to define p53 status in a timely fashion and emergence of immunotherapeutics as an active modality in melanoma. Data Safety Monitoring board recommended closure to accrual after documentation of hypotension and hypoglycemia in the small cohort of patients actually treated.|Days 3, 8, and 12 of Cycles 1 and 2||04/2017||||
771803|NCT00729807|Secondary|Wild-type p53 and S100B Status at Baseline|Zero participants analyzed. Data was not analyzed owing to the small number of patients actually treated with pentamidine; most patients screened could not enter owing to inability to define p53 status in a timely fashion and emergence of immunotherapeutics as an active modality in melanoma. Data Safety Monitoring board recommended closure to accrual after documentation of hypotensions and hypoglycemia in the small cohort of patients actually treated.|Baseline||04/2017||||
771804|NCT00729807|Primary|CR, PR, Stable Disease|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease, neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease, taking as reference the smallest sum of the longest diameter since the treatment started. (Therasse, P., Arbuck, S.G., Eisenhauer, E.A., Wanders, J., Kaplan, R.S., Rubinstein, J., Van Glabbeke, M., van Oosterom, A.T., Christian, M.C., Gwyther, S.G. (2000) J Natl Cancer Inst 92, 205-16)|Every 6-8 weeks|||participants|||Number
771805|NCT00729833|Secondary|Number of Participants With Objective Response (OR)|Objective response (OR) was based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. CR was the complete disappearance of all target and non-target disease, no new lesions, or the normalization of markers (if markers were being followed). PR was greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions, no unequivocal progression of non-target disease, no new lesions, or no reappearance of lesions after a CR. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.|Baseline, Day 15 of every 2 cycles until disease progression up to follow-up (approximately 28 days following the last dose of study drug)|Safety Analysis Set: All enrolled participants who received at least 1 dose of study medication.||participants|||Number
771806|NCT00729833|Secondary|Number of Participants With Anti-Drug Antibodies (ADA)|Assays for ADA assessment specific for figitumumab would have provided information regarding an immune response to the compound.|0.5 hour pre-infusion on Day 1 in Cycles 1 and 2, at end of treatment, and during the last scheduled follow-up visit (5 months from the last dose of study drug)|ADA Analysis Set: Participants who started treatment with study medication and provided at least 1 on-study ADA sample. Due to early termination of the study, ADA samples were not assayed.|||||
771807|NCT00729833|Secondary|Plasma Concentration at 24 Hours Postdose (C24) of Sunitinib||24 hours postdose on Day 15 of Cycle 1|PK Analysis Set: Participants who received all scheduled doses of both drugs and completed all required PK assessments in the dose expansion cohort (figitumumab 10 mg/kg + sunitinib 25 mg CDD).||ng/mL||Geometric Coefficient of Variation|Geometric Mean
771808|NCT00729833|Secondary|Trough Plasma Concentration (Ctrough) of Sunitinib||0.5 hour predose on Day 1 of Cycle 2|PK Analysis Set: Participants who received all scheduled doses of both drugs and completed all required PK assessments in the dose expansion cohort (figitumumab 10 mg/kg + sunitinib 25 mg CDD).||ng/mL||Geometric Coefficient of Variation|Geometric Mean
771809|NCT00729833|Secondary|Area Under the Curve From Time Zero to 24 Hours Postdose (AUC24) of Sunitinib|AUC24 is the area under the plasma concentration versus time curve from time zero (predose) to 24 hours postdose (0 to 24).|0.5 hour predose and 2, 4, 6, 8, 12, and 24 hours postdose on Day 15 of Cycle 1|PK Analysis Set: Participants who received all scheduled doses of both drugs and completed all required PK assessments in the dose expansion cohort (figitumumab 10 mg/kg + sunitinib 25 mg CDD).||nanogram*hour/milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
771810|NCT00729833|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Sunitinib||0.5 hour predose and 2, 4, 6, 8, 12, and 24 hours postdose on Day 15 of Cycle 1|PK Analysis Set: Participants who received all scheduled doses of both drugs and completed all required PK assessments in the dose expansion cohort (figitumumab 10 mg/kg + sunitinib 25 mg CDD).||hours||Full Range|Median
771829|NCT00729859|Secondary|Follicle Stimulating Hormone (FSH)||Baseline, 28 days|Per protocol, the first 8 subjects were assigned to Group 1. Subsequent subjects were randomly assigned to Group 2 or Group 3.||IU/L||Standard Deviation|Mean
771812|NCT00729833|Secondary|Plasma Decay Half-Life (t1/2) of Figitumumab|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0.5 hour predose and 1 hour post-infusion on Days 1, 2, 4, 8, and 15 of Cycles 1 and 4|PK Analysis Set: Participants who received all scheduled doses of both drugs and completed all required PK assessments in the dose expansion cohort (figitumumab 10 mg/kg + sunitinib 25 mg CDD); n=number of participants in the indicated cycle.||hours||Standard Deviation|Mean
771813|NCT00729833|Secondary|Area Under the Curve From Time Zero to Day 22 [AUC504] of Figitumumab|AUC504 is the area under the plasma concentration versus time curve from time zero (predose) to Day 22, where Day 22 is the nominal time (504 hours) of the predose sample for the next cycle.|0.5 hour predose and 504 hours (Day 22) post-infusion of Cycles 1 and 4|PK Analysis Set: Participants who received all scheduled doses of both drugs and completed all required PK assessments in the dose expansion cohort (figitumumab 10 mg/kg + sunitinib 25 mg CDD); n=number of participants in the indicated cycle.||mg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
771814|NCT00729833|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Figitumumab|AUClast is the area under the plasma concentration time-curve from zero to the last measured concentration.|0.5 hour predose and 1 hour post-infusion on Days 1, 2, 4, 8, 15, and 22 of Cycles 1 and 4|PK Analysis Set: Participants who received all scheduled doses of both drugs and completed all required PK assessments in the dose expansion cohort (figitumumab 10 mg/kg + sunitinib 25 mg CDD); n=number of participants in the indicated cycle.||milligram*hour/milliliter (mg*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
771815|NCT00729833|Secondary|Plasma Concentration at the End of Infusion (Cendinf) of Figitumumab||0.5 hour predose and 1 hour post-infusion on Day 1 of Cycles 1 and 4|Pharmacokinetic (PK) Analysis Set: Participants who received all scheduled doses of both drugs and completed all required PK assessments in the dose expansion cohort (figitumumab 10 mg/kg + sunitinib 25 mg CDD); n=number of participants in the indicated cycle.||milligram/liter (mg/L)||Geometric Coefficient of Variation|Geometric Mean
771816|NCT00729833|Secondary|Percentage of Participants With Blood Chemistry Laboratory Test Abnormality|Percentage of participants with blood chemistry laboratory abnormalities of CTC severity grades 1, 2, 3, or 4 (grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=life-threatening or disabling).|Baseline, Day 1 of every cycle, Days 8 and 15 of Cycle 1, up to end of treatment (28 days post last dose)|Safety Analysis Set: All enrolled participants who received at least 1 dose of study medication; n=number of participants evaluable for this outcome measure, respectively.||percentage of participants|||Number
771817|NCT00729833|Secondary|Percentage of Participants With Hematologic Laboratory Test Abnormality|Percentage of participants with hematologic laboratory abnormalities of CTC severity grades 1, 2, 3, or 4 (grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=life-threatening or disabling).|Baseline, Day 1 of every cycle, Days 8 and 15 of Cycle 1, up to end of treatment (28 days post last dose)|Safety Analysis Set: All enrolled participants who received at least 1 dose of study medication.||percentage of participants|||Number
771818|NCT00729833|Secondary|Percentage of Participants With Treatment-Emergent Adverse Events, by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for Adverse Events Grade Version 3.0|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs are events occurred between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. If the same participant in a given treatment had more than one occurrence in the same preferred term event category, only the worst CTCAE grade was reported. Severity grades were 0 (no change from normal or reference range), 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening or disabling), and 5 (death).|Baseline, Day 1 of every cycle, Days 8 and 15 of Cycle 1, up to end of treatment (28 days post last dose)|Safety Analysis Set: All enrolled participants who received at least 1 dose of study medication.||percentage of participants|||Number
771819|NCT00729833|Primary|Number of Participants With Dose-Limiting Toxicities (DLT)|"Number of participants with treatment-related Grade 3/4 toxicities that occurred during the defined time frame or that resulted in greater than or equal to (>=) 7 days delay in administration of Cycle 2.
Toxicities were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0."|Baseline up to the end of Cycle 1 (each cycle=3 weeks)|Per-Protocol Analysis Set: All participants who started treatment and who did not have first cycle major treatment deviations.||participants|||Number
771820|NCT00729846|Primary|Visual Acuity: Percentage of Patients Losing 3 or More Lines(15 Letters) of Visual Acuity From Baseline.||1 Year|||percent of participants|||Number
771821|NCT00729859|Secondary|Fasting Lipid Levels||Baseline, Day 28, Day 56|per protocol||mmol/L||Standard Deviation|Mean
771822|NCT00729859|Secondary|Fasting Serum Insulin||Baseline, Day 28, Day 56|per protocol||picomolar||Standard Deviation|Mean
771823|NCT00729859|Secondary|Homeostasis Model of Insulin Resistance (HOMA-IR)|HOMA IR is a measure of insulin sensitivity calculated using fasting insulin and glucose concentration in a participants blood. Higher HOMA IR numbers are associated with increased insulin resistance and decreased insulin sensitivity.|Baseline, Day 28, Day 56|per protocol||HOMA score||Standard Deviation|Mean
771824|NCT00729859|Secondary|Quantitative Insulin Sensitivity Check Index (QUICKI)|QUICKI is a measure of insulin sensitivity calculated using fasting insulin and glucose concentration in a participants blood. Higher QUICKI are associated with decreased insulin resistance and increased insulin sensitivity.|Baseline, Day 28, Day 56|per protocol||QUICKI index||Standard Deviation|Mean
771825|NCT00729859|Secondary|Sex Hormone Binding Globulin (SHBG)||Baseline, Day 28|Per protocol, the first 8 subjects were assigned to Group I. Subsequent subjects were randomly assigned to Group 2 or Group 3.||nmol/L||Standard Deviation|Mean
771826|NCT00729859|Secondary|Estradiol Concentration||Baseline, Day 28|Per protocol, the first 8 subjects were assigned to Group 1. Subsequent subjects were randomly assigned to Group 2 or Group 3.||pmol/L||Standard Deviation|Mean
771827|NCT00729859|Secondary|Testosterone Concentration||Baseline, Day 28|Per protocol, the first 8 subjects were assigned to group I. Subsequent subjects were randomized to group 2 or group 3.||nmol/L||Standard Deviation|Mean
771828|NCT00729859|Secondary|Luteinizing Hormone Concentration (LH)||Baseline, Day 28|The analysis was per protocol. Following screening, the first 8 subjects were assigned to group I, and subsequent subjects enrolled were randomly assigned to either group 2 or 3.||IU/L||Standard Deviation|Mean
771832|NCT00729924|Primary|Penetration of Raltegravir (RGV) Into Cerebrospinal Fluid (CSF) Based on Plasma Area-under-the-curve.|The primary outcome for this study was the ratio of the 4-hour CSF concentration value (ng/mL) to the partial plasma area-under-the-curve 0-4h value (h*ng/mL).|Day 7|||1/h||Inter-Quartile Range|Median
771833|NCT00729937|Secondary|Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population|As a quality of life measure, participants maintained a memory aid from Day 1 to Day 14 to track measures such as use of other, non-study medications such as analgesics. Each participant is summarized by the last day of reported analgesic usage, from the start of treatment with study intervention. The maximum number of days assessed, 14, was assigned to participants who were still taking analgesic medications by the end of the assessment period.|Day 1 through 14|All subjects who took at least one dose of study medication were included in the intent to treat population.||participants|||Number
771834|NCT00729937|Secondary|Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population|As a quality of life measure, participants maintained a memory aid from Day 1 to Day 14 to track measures such as use of other, non-study medications such as analgesics. Each participant is summarized by the last day of reported analgesic usage, from the start of treatment with study intervention. The maximum number of days assessed, 14, was assigned to participants who were still taking analgesic medications by the end of the assessment period.|Day 1 through 14|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.||participants|||Number
771835|NCT00729937|Secondary|Mean Days Missed From Normal Activities in the Intent to Treat Population|As a quality of life measure, participants maintained a memory aid from Day 1 to Day 14 to track measures such as participation in normal life activities. The maximum number of days assessed, 14, was assigned to participants who had not yet resumed normal activities by the end of the assessment period.|Day 1 through 14|All subjects who took at least one dose of study medication were included in the intent to treat population.||days||Standard Deviation|Mean
771836|NCT00729937|Secondary|Mean Days Missed From Normal Activities in the Per Protocol Population|As a quality of life measure, participants maintained a memory aid from Day 1 to Day 14 to track measures such as participation in normal life activities. The maximum number of days assessed, 14, was assigned to participants who had not yet resumed normal activities by the end of the assessment period.|Day 1 through 14|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.||days||Standard Deviation|Mean
771837|NCT00729937|Secondary|Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class|All adverse events were recorded through the test of cure visit; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit. All AEs were assessed for association with the study product by a clinician and were considered associated with study product if the event was temporally related to the administration of the study product and no other etiology more likely explains the event. Associated adverse events are summarized by MedDRA System Organ Class.|Day 1 through Day 49-63|All subjects who took at least one dose of study medication were included in the intent to treat population.||participants|||Number
771838|NCT00729937|Secondary|Number of Participants With Infections in Household Contacts Through the EFV Visit in the Intent to Treat Population|At each follow-up visit, participants were asked about history of skin infections in household members (e.g., similar skin infection in a family member). This outcome measure relied solely on participant reporting. Participants who reported having a family member with a similar infection though the extended follow-up visit are summarized.|Day 1 through Day 49-63|All subjects who took at least one dose of study medication were included in the intent to treat population.||participants|||Number
771839|NCT00729937|Secondary|Number of Participants With Infections in Household Contacts Through the EFV Visit in the Per Protocol Population|At each follow-up visit, participants were asked about history of skin infections in household members (e.g., similar skin infection in a family member). This outcome measure relied solely on participant reporting. Participants who reported having a family member with a similar infection though the extended follow-up visit are summarized.|Day 1 through Day 49-63|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.||participants|||Number
771840|NCT00729937|Secondary|Number of Participants With Infections in Household Contacts Through the TOC Visit in the Intent to Treat Population|At each follow-up visit, participants were asked about history of skin infections in household members (e.g., similar skin infection in a family member). This outcome measure relied solely on participant reporting. Participants who reported having a family member with a similar infection though the test-of-cure visit are summarized.|Day 1 through Day 14-21|All subjects who took at least one dose of study medication were included in the intent to treat population.||participants|||Number
771841|NCT00729937|Secondary|Number of Participants With Infections in Household Contacts Through the TOC Visit in the Per Protocol Population|At each follow-up visit, participants were asked about history of skin infections in household members (e.g., similar skin infection in a family member). This outcome measure relied solely on participant reporting. Participants who reported having a family member with a similar infection though the test-of-cure visit are summarized.|Day 1 through Day 14-21|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.||participants|||Number
771842|NCT00729937|Secondary|Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the EFV Visit in the Intent to Treat Population|Participants were evaluated for the development of a recurrent, or repeat, infection at the original infection site. Participants who were reported to have developed a recurrent infection though the extended follow-up visit are summarized.|Day 1 through Day 49-63|All subjects who took at least one dose of study medication were included in the intent to treat population.||participants|||Number
771843|NCT00729937|Secondary|Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the EFV Visit in the Per Protocol Population|Participants were evaluated for the development of a recurrent, or repeat, infection at the original infection site. Participants who were reported to have developed a recurrent infection though the extended follow-up visit are summarized.|Day 1 through Day 49-63|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.||participants|||Number
771844|NCT00729937|Secondary|Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the TOC Visit in the Intent to Treat Population|Participants were evaluated for the development of a recurrent, or repeat, infection at the original infection site. Participants who were reported to have developed a recurrent infection though the test-of-cure visit are summarized.|Day 1 through Day 14-21|All subjects who took at least one dose of study medication were included in the intent to treat population.||participants|||Number
771845|NCT00729937|Secondary|Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the TOC Visit in the Per Protocol Population|Participants were evaluated for the development of a recurrent, or repeat, infection at the original infection site. Participants who were reported to have developed a recurrent infection though the test-of-cure visit are summarized.|Day 1 through Day 14-21|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.||participants|||Number
771846|NCT00729937|Secondary|Number of Participants With Development of an Invasive Infection Through the EFV Visit in the Intent to Treat Population|Participants were evaluated for invasive infection, which included, but was not limited to, findings of severe sepsis/septic shock, endocarditis, pneumonia, necrotizing soft tissue, osteomyelitis, and bacteremia. A positive response to at least one finding was considered invasive infection for this outcome measure.|Day 1 through Day 49-63|All subjects who took at least one dose of study medication were included in the intent to treat population.||participants|||Number
771847|NCT00729937|Secondary|Number of Participants With Development of an Invasive Infection Through the EFV Visit in the Per Protocol Population|Participants were evaluated for invasive infection, which included, but was not limited to, findings of severe sepsis/septic shock, endocarditis, pneumonia, necrotizing soft tissue, osteomyelitis, and bacteremia. A positive response to at least one finding was considered invasive infection for this outcome measure.|Day 1 through Day 49-63|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.||participants|||Number
771848|NCT00729937|Secondary|Number of Participants With Development of an Invasive Infection Through the TOC Visit in the Intent to Treat Population|Participants were evaluated for invasive infection, which included, but was not limited to, findings of severe sepsis/septic shock, endocarditis, pneumonia, necrotizing soft tissue, osteomyelitis, and bacteremia. A positive response to at least one finding was considered invasive infection for this outcome measure.|Day 1 through Day 14-21|All subjects who took at least one dose of study medication were included in the intent to treat population.||participants|||Number
771849|NCT00729937|Secondary|Number of Participants With Development of an Invasive Infection Through the TOC Visit in the Per Protocol Population|Participants were evaluated for invasive infection, which included, but was not limited to, findings of severe sepsis/septic shock, endocarditis, pneumonia, necrotizing soft tissue, osteomyelitis, and bacteremia. A positive response to at least one finding was considered invasive infection for this outcome measure.|Day 1 through Day 14-21|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.||participants|||Number
771850|NCT00729937|Secondary|Number of Participants Requiring Surgical Intervention Through the Extended Follow-up Visit (EFV) in the Intent to Treat Population|All surgical procedures such as incision and drainage (I&D) and debridement that were related to the current infection under study or significant to the health of the subject, except for the initial I&D of an abscess for participants in the abscess or infected wound arms, were recorded. Participants who required a surgical intervention between the initial enrollment (excluding the initial I&D as applicable) and the extended follow-up visit are summarized.|Day 1 through Day 49-63|All subjects who took at least one dose of study medication were included in the intent to treat population.||participants|||Number
771851|NCT00729937|Secondary|Number of Participants Requiring Surgical Intervention Through the Extended Follow-up Visit (EFV) in the Per Protocol Population|All surgical procedures such as incision and drainage (I&D) and debridement that were related to the current infection under study or significant to the health of the subject, except for the initial I&D of an abscess for participants in the abscess or infected wound arms, were recorded. Participants who required a surgical intervention between the initial enrollment (excluding the initial I&D as applicable) and the extended follow-up visit are summarized.|Day 1 through Day 49-63|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.||participants|||Number
771852|NCT00729937|Secondary|Number of Participants Requiring Surgical Intervention Through the TOC Visit in the Intent to Treat Population|All surgical procedures such as incision and drainage (I&D) and debridement that were related to the current infection under study or significant to the health of the subject, except for the initial I&D of an abscess for participants in the abscess or infected wound arms, were recorded. Participants who required a surgical intervention between the initial enrollment (excluding the initial I&D as applicable) and the test-of-cure visit are summarized.|Day 1 through Day 14-21|All subjects who took at least one dose of study medication were included in the intent to treat population.||participants|||Number
781594|NCT00795951|Primary|Diagnostic Performance: Caine Mix|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application|||participants|||Number
771853|NCT00729937|Secondary|Number of Participants Requiring Surgical Intervention Through the TOC Visit in the Per Protocol Population|All surgical procedures such as incision and drainage (I&D) and debridement that were related to the current infection under study or significant to the health of the subject, except for the initial I&D of an abscess for participants in the abscess or infected wound arms, were recorded. Participants who required a surgical intervention between the initial enrollment (excluding the initial I&D as applicable) and the test-of-cure visit are summarized.|Day 1 through Day 14-21|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.||participants|||Number
771854|NCT00729937|Secondary|Number of Participants With Each Microbiological Outcome at the TOC Visit in the Per Protocol Population|Participants were categorized for the microbiological outcome with Presumed eradication if they were not deemed a clinical failure through TOC. Those who were deemed a clinical failure through the TOC were classified as one of the following: Persistence=persistent growth of a pre-therapy pathogen; New infection=growth of a new pathogen and eradication of initial pathogen; Super-infection=growth of a new pathogen in addition to persistent growth of pre-therapy pathogen; Unclassified=no specimen for culture or growth of a pathogen in subsequent culture specimen of cellulitis participants, or for whom initial culture specimens were negative or were not obtained for infected wound and abscess participants; or Indeterminate=not meeting any one of the above microbiologic outcome criteria.|Day 14-21|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.||participants|||Number
771855|NCT00729937|Secondary|Number of Participants by Composite Clinical Outcome at the TOC Visit in the Per Protocol Population|Participants were categorized as composite clinical cure if they had resolution of all symptoms/signs of infection, or improvement to such an extent that no additional antibiotic therapy and/or surgical procedures were necessary. Participants were categorized as composite clinical failure if they had lack of resolution of all signs and symptoms of infection to such an extent that further antibiotic therapy and/or surgical procedures were necessary.|Day 14-21|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.||participants|||Number
771856|NCT00729937|Secondary|Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population|The area of erythema was measured in square centimeters at baseline and at the TOC visit. For each subject, the change in area was calculated as the area at TOC subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction.|Day 1 to Day 14-21|All subjects who took at least one dose of study medication were included in the intent to treat population.||participants|||Number
771857|NCT00729937|Secondary|Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population|The area of erythema was measured in square centimeters at baseline and at the TOC visit. For each subject, the change in area was calculated as the area at TOC subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction.|Day 1 to Day 14-21|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.||participants|||Number
771858|NCT00729937|Secondary|Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population|The area of erythema was measured in square centimeters at baseline and at the end-of-therapy visit. For each subject, the change in area was calculated as the area at end-of-therapy subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction.|Day 1 to Day 8-10|All subjects who took at least one dose of study medication were included in the intent to treat population.||participants|||Number
771859|NCT00729937|Secondary|Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population|The area of erythema was measured in square centimeters at baseline and at the end-of-therapy visit. For each subject, the change in area was calculated as the area at end-of-therapy subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction.|Day 1 to Day 8-10|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.||participants|||Number
771860|NCT00729937|Secondary|Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population|The area of erythema was measured in square centimeters at baseline and at the on-therapy visit. For each subject, the change in area was calculated as the area at on-therapy subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction.|Day 1 to Day 3-4|All subjects who took at least one dose of study medication were included in the intent to treat population.||participants|||Number
772399|NCT00725296|Primary|Average Overall Dose of All Infusions Per Participant|The average overall dose of all infusions among all Infliximab-naive participants measured in mg/kg.|Up to 24 Months|152 out of the 159 Infliximab-naive participants were treated in the active phase.||mg/kg||Standard Deviation|Mean
771861|NCT00729937|Secondary|Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population|The area of erythema was measured in square centimeters at baseline and at the on-therapy visit. For each subject, the change in area was calculated as the area at on-therapy subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction.|Day 1 to Day 3-4|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.||participants|||Number
771862|NCT00729937|Primary|Number of Participants With Clinical Cure as of the Test-of-Cure (TOC) Visit in the Per Protocol Population|Clinical cure at TOC was defined as no failure on any previous visit up through the TOC, absence of fever, and resolution or minimal presence of all the following signs and symptoms from baseline based on clinician assessment of erythema, swelling, and tenderness. A participant would have been a clinical failure at the On Therapy (OTV) visit with presence of fever attributable to the infection being studied, increase in erythema by 25% or more, or worsening of both swelling and tenderness based on clinical assessment. A participant would have been a clinical failure at the End of Therapy (EOT) visit with presence of fever attributable to the infection being studied, increase or no improvement in erythema, or no improvement in either swelling or tenderness based on clinical assessment.|Days 14-21|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.||participants|||Number
771863|NCT00729937|Secondary|Number of Participants With Clinical Cure as of the TOC Visit in the Intent to Treat Population|Clinical cure at TOC was defined as no failure on any previous visit up through the TOC, absence of fever, and resolution or minimal presence of all the following signs and symptoms from baseline based on clinician assessment of erythema, swelling, and tenderness. A participant would have been a clinical failure at the On Therapy (OTV) visit with presence of fever attributable to the infection being studied, increase in erythema by 25% or more, or worsening of both swelling and tenderness based on clinical assessment. A participant would have been a clinical failure at the End of Therapy (EOT) visit with presence of fever attributable to the infection being studied, increase or no improvement in erythema, or no improvement in either swelling or tenderness based on clinical assessment.|Days 14-21|All subjects who took at least one dose of study medication were included in the intent to treat population.||participants|||Number
771864|NCT00730015|Secondary|12-week Change in Constipation Severity|"Constipation severity was based on a 5-point ordinal scale where a value of l is none and a value of 5 is very severe."|Change from Baseline to Week 12|643 randomized patients received at least 1 dose of study drug; 642 patients were included in the ITT Population; 10 patients who dropped out prior to finishing 1 week of the trial have missing data. An observed-cases approach to missing postbaseline data was applied.||units on a scale||Standard Error|Least Squares Mean
771865|NCT00730015|Secondary|12-week Change in Bloating|"Bloating was based on a 5-point scale where a value of l is none and a value of 5 is very severe."|Change from Baseline to Week 12|643 randomized patients received at least 1 dose of study drug. 642 patients were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.||units on a scale||Standard Error|Least Squares Mean
771866|NCT00730015|Secondary|12-week Change in Abdominal Discomfort|"Abdominal discomfort is based on a 5-point scale where a value of l is none and a value of 5 is very severe."|Change from Baseline to Week 12|643 randomized patients received at least 1 dose of study drug. 642 patients were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.||units on a scale||Standard Error|Least Squares Mean
771867|NCT00730015|Secondary|12-week Change in Severity of Straining|"Severity of Straining is measured on a 5-point scale, where a value of 1 is not at all and a value of 5 is an extreme amount."|Change from Baseline to Week 12|643 randomized patients received at least 1 dose of study drug; 642 patients were included in the ITT Population; 101 patients with no pretreatment spontaneous bowel movements were excluded from the Straining analysis. An observed-cases approach to missing postbaseline data was applied.||units on a scale||Standard Error|Least Squares Mean
771868|NCT00730015|Secondary|12-week Change in Stool Consistency|"The consistency of each BM was assessed using the 7-point Bristol Stool Form Scale:
= separate hard lumps like nuts [difficult to pass]
= sausage shaped but lumpy
= like a sausage but with cracks on surface
= like a sausage or snake, smooth and soft
= soft blobs with clear-cut edges [passed easily]
= fluffy pieces with ragged edges, a mushy stool
= watery, no solid pieces [entirely liquid]"|Change from Baseline to Week 12|643 randomized patients received at least 1 dose of study drug; 642 patients were included in the ITT Population; 101 patients with no pretreatment spontaneous bowel movements were excluded from the Stool Consistency analysis. An observed-cases approach to missing postbaseline data was applied.||units on a scale||Standard Error|Least Squares Mean
771869|NCT00730015|Secondary|12-Week Spontaneous Bowl Movement (SBM) Frequency|The number of SBMs per week.|Change from Baseline to Week 12|643 randomized patients received at least 1 dose of study drug. 642 patients were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.||SBMs per Week||Standard Error|Least Squares Mean
771870|NCT00730015|Secondary|12-Week Complete Spontaneous Bowel Movement (CSBM) Frequency|The number of CSBMs per week.|Change from Baseline to Week 12|643 randomized patients received at least 1 dose of study drug. 642 patients were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.||CSBMs per Week||Standard Error|Least Squares Mean
771871|NCT00730015|Primary|Complete Spontaneous Bowel Movement (CSBM) Overall Responder|"A 12-week CSBM Overall Responder was defined as a patient who for at least 9 of the 12 weeks of the treatment period had a CSBM weekly frequency rate that was 3 or greater and increased by 1 or more from baseline. A CSBM was defined as a spontaneous bowel movement (SBM) that was associated with a sense of complete evacuation.
An SBM was defined as a bowel movement (BM) that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM."|Change from Baseline to Week 12|643 randomized patients received at least 1 dose of study drug. 642 patients were included in the Intent to Treat (ITT) Population. An observed-cases approach to missing postbaseline data was applied.||participants|||Number
771872|NCT00730028|Secondary|Percentage of Participants Achieving Clinical Cure at the One Month Follow-up (OMFU) Visit for the Intent-to-Treat (ITT) Population.|Measures of clinical cure and clinical failure are the same as those defined for the primary efficacy outcome measure, with one addition. At the OMFU, relapse (the return of the original infection after initial improvement) or recurrence (return of skin infection at original site after cure of original infection) of SSTI was scored as clinical failure.|OMFU visit|All participants enrolled in the trial.||percentage of participants||95% Confidence Interval|Number
771873|NCT00730028|Secondary|Percentage of Participants Achieving Clinical Cure at the One Month Follow-up (OMFU) Visit for the Evaluable Population.|Measures of clinical cure and clinical failure are the same as those defined for the primary efficacy outcome measure, with one addition. At the OMFU, relapse (the return of the original infection after initial improvement) or recurrence (return of skin infection at original site after cure of original infection) of SSTI was scored as clinical failure.|OMFU visit|The efficacy evaluable population was comprised of all participants who had outcomes determined at the OMFU visit.||percentage of participants||95% Confidence Interval|Number
771874|NCT00730028|Secondary|Percentage of Participants Achieving Clinical Cure at the End of Treatment (EOT) Visit for the Intent-to-Treat (ITT) Population.|Measures of clinical cure and clinical failure are the same as those defined for the primary efficacy outcome measure.|EOT visit within 48 hours of completion of therapy|All participants enrolled in the trial.||percentage of participants||95% Confidence Interval|Number
771875|NCT00730028|Secondary|Percentage of Participants Achieving Clinical Cure at the End of Treatment (EOT) Visit for the Evaluable Population.|Measures of clinical cure and clinical failure are the same as those defined for the primary efficacy outcome measure.|EOT visit within 48 hours of completion of therapy|The efficacy evaluable population was comprised of all participants who had outcomes determined at the EOT visit.||percentage of participants||95% Confidence Interval|Number
771876|NCT00730028|Primary|Percentage of Participants Achieving Clinical Cure, Defined as Absence of Clinical Failure, in the Intent-to-Treat (ITT) Population.|"Clinical failure is defined as the occurence of any of the following:
Lack of resolution at the Test of Cure (TOC) visit in any or all of the following: erythema, tenderness, purulent drainage, swelling, and local warmth. Erythema or tenderness that was considered due the surgical therapy itself (incision and drainage), was not considered to be indicative of clinical failure.
Occurrence of a SSTI at another site other than the site(s) under study.
Intolerance of study medication or a treatment-limiting adverse reaction necessitating discontinuation of study drug within the first 48 hours.
Administration of other antimicrobial therapy for treatment of a SSTI at any time through the TOC visit.
Unplanned surgical procedure for the infection under study at any time through the TOC visit.
Hospitalization for treatment of active or invasive infection at any time through the TOC visit."|Test of cure (TOC) (7-10 days after completion of therapy)|The ITT population was comprised of all participants enrolled in the trial.||percentage of participants||95% Confidence Interval|Number
771877|NCT00730028|Secondary|Number of Participants Reporting Adverse Events That Are Treatment Limiting.|Participants were issued a Memory Aid to record symptoms for 10 days post product administration. At study visits, the staff reviewed the memory aid and elicited as much information as possible about any reported symptoms. Occurrence of adverse events was solicited in the memory aid and during study visits. Reported symptoms, both solicited and unsolicited, were recorded as Adverse Events. For these results, adverse events that resulted in discontinuation of study treatment for the participant were considered treatment limiting.|End of Treatment (EOT) (48 hours after completion of therapy); Test of Cure (TOC) (7-10 days after completion of therapy); One Month Follow-up Visit (OMFU)|Participants who received treatment with either clindamycin or TMP/SMX in the cellulitis or larger abscess group and participants who received treatment with either clindamycin, TMP/SMX, or placebo in the limited abscess group.||participants|||Number
771878|NCT00730028|Secondary|Number of Participants Reporting Adverse Events.|Subjects were issued a Memory Aid to record symptoms for 10 days post product administration. At study visits, the staff reviewed the memory aid and elicited as much information as possible about any reported symptoms. Occurrence of adverse events was solicited in the memory aid and during study visits. Reported symptoms, both solicited and unsolicited, were recorded as Adverse Events.|End of Treatment (EOT) (48 hours after completion of therapy); Test of Cure (TOC) (7-10 days after completion of therapy); One Month Follow-up Visit (OMFU)|Participants who received treatment with either clindamycin or TMP/SMX in the cellulitis or larger abscess group and participants who received treatment with either clindamycin, TMP/SMX, or placebo in the limited abscess group.||participants|||Number
771879|NCT00730028|Primary|Percentage of Participants Achieving Clinical Cure, Defined as Absence of Clinical Failure, in the Evaluable Population.|"Clinical failure is defined as the occurence of any of the following:
Lack of resolution at the Test of Cure (TOC) visit in any or all of the following: erythema, tenderness, purulent drainage, swelling, and local warmth. Erythema or tenderness that was considered due the surgical therapy itself (incision and drainage), was not considered to be indicative of clinical failure.
Occurrence of a SSTI at another site other than the site(s) under study.
Intolerance of study medication or a treatment-limiting adverse reaction necessitating discontinuation of study drug within the first 48 hours.
Administration of other antimicrobial therapy for treatment of a SSTI at any time through the TOC visit.
Unplanned surgical procedure for the infection under study at any time through the TOC visit.
Hospitalization for treatment of active or invasive infection at any time through the TOC visit."|Test of cure (TOC) (7-10 days after completion of therapy)|The efficacy evaluable population was comprised of all participants who had outcomes determined at the Test of Cure (TOC) visit.||percentage of participants||95% Confidence Interval|Number
771880|NCT00730041|Secondary|Measurement of Usage (Hours) of the Continuous Positive Airway Pressure Machine as Recorded by SmartCard (Home Compliance Monitor)|The CPAP machine has an internal clock/calendar, and capabilities to record usage onto a removable data card the size of a credit card. Data is recorded from the first time the machine is turned on to the last time the machine is turned on during a given period in which the SmartCard is present in the machine. The SmartCard records all days during the given period and keeps track of days in which the CPAP machine is used and days in which it is not used. The SmartCard data is able to be downloaded to a computer for review and analysis.|Baseline and 4 months post-procedure|Five participants in the sham group did not return their SmartCards at the final study visit.||Average hours per day of days used||Standard Deviation|Mean
771881|NCT00730041|Secondary|Functional Outcomes of Sleep Questionnaire (FOSQ), a Validated Measure the Impact of Excessive Sleepiness on Multiple Activities of Daily Living.|The FOSQ can assess the quality of sleep and this scale is a validated measure the impact of excessive sleepiness on multiple activities of daily living. It has 30 questions in 5 subgroups of general productivity (8 questions), social outcome (2), activity level (9), vigilance (7), and intimate relationships and sexual activity (4). Responses for each question range from 1 (extreme difficulty or low activity level) to 4 (no difficulty or high activity level) for each subgroup. A mean is calculated for each subgroup, and then the mean of the subgroups is calculated and multiplied by 5.|Baseline and 4 months post-procedure|Two subjects became lost to follow-up and did not return for the final study visit.||Scores on a Scale||Standard Deviation|Mean
771882|NCT00730041|Secondary|Epworth Sleepiness Scale (ESS), a Validated Measure of Daytime Sleepiness.|The Epworth Sleepiness Scale (ESS) was included in the subject questionnaire as a tool to further assess the quality of sleep for each subject throughout the follow-up period. This scale is a validated clinical indicator that quantifies the patient’s chance of falling asleep during eight different activities of daily living such as reading, talking, resting and driving. Each of the eight questions has four possible responses: 0 = would never doze, 1 = slight chance of dozing, 2 = moderate chance of dozing to 3 = high chance of dozing, for a possible maximum score of 24.|Baseline and 4 months post-procedure|Two participants became lost to follow-up and did not return for the final study visit.||Scores on a Scale||Standard Deviation|Mean
771883|NCT00730041|Secondary|Visual Analog Scale (VAS) to Measure Continuous Positive Airway Pressure (CPAP) Satisfaction.|The candidate was asked to complete a questionnaire that included a VAS describing CPAP satisfaction. Scores ranged from 0 (very unsatisfied) to 10 (very satisfied).|Baseline and 4 months post-procedure|Two participants in the sham group became lost to follow-up and did not return for the final follow-up.||Scores on a Scale||Standard Deviation|Mean
771884|NCT00730041|Secondary|Measurement of Total Leak as Recorded by SmartCard (Home Compliance Feature of the Continuous Positive Airway Pressure Machine)|Leak is an indicator of mask/headgear fit and can also be used to substantiate or contradict an assigned therapeutic pressure. Total leak is the sum of intentional leak to prevent carbon dioxide rebreathing and unintentional leak. Each mask has a known amount of leak (the intentional leak), and subjects were instructed not to changes masks to minimize this variable. Approximate range is 0-100, and the amount of leak increases as the number increases. Average leak values are in the 20-50 liters per minute range. The CPAP machine records leak data during each night of usage and can average.|Baseline and 4 months post-procedure|Five participants in the sham group did not return their SmartCards at the final study visit.||Units on a scale||Standard Deviation|Mean
771885|NCT00730041|Secondary|Visual Analog Scale (VAS) for Continuous Positive Airway Pressure (CPAP) Comfort Score.|The candidate was asked to complete a questionnaire that included a VAS describing CPAP therapy comfort. Scores ranged from 0 (very uncomfortable) to 10 (very comfortable).|Baseline and 4 months post-procedure|Two participants in the sham group became lost to follow-up and did not return for the final follow-up.||Scores on a Scale||Standard Deviation|Mean
771886|NCT00730041|Primary|Therapeutic Pressure From a Polysomnogram (PSG) With Continuous Positive Airway Pressure (CPAP) Titration|The American Academy of Sleep Medicine’s (AASM) recommended treatment for patients with obstructive sleep apnea (OSA) is Continuous Positive Airway Pressure (CPAP), which is a life-long therapy that requires subjects to wear a nasal or facial mask connected to a portable airflow generator while sleeping. CPAP therapy is intended to prevent collapse of the upper airway. CPAP pressures are measured in centimeters of water, and range in whole numbers from 4cm H2O to 20cm H2O. The therapeutic pressure is usually determined during overnight polysomnography and usually performed by a technician.|Baseline and 3 months post-procedure|50 of 51 total participants returned to the sleep lab for the 90-day PSG. All 50 participants are part of the primary endpoint analysis.||centimeters of water (cm H2O)||Standard Deviation|Mean
771887|NCT00730730|Secondary|Number of Limbs With Improvement Using Ankle-brachial Index and Toe Brachial Index to Determine Hemodynamic Success.|"Improvement in ankle-brachial index (ABI) or toe-brachial index (TBI) > 0.10 over pre-procedure level OR deterioration by ≤ 0.15 from first post-procedure exam OR pulse volume recording (PVR) distal to the target lesion treated maintained at ≥ 5 mm above pre-procedure tracing for those subjects with no pre-procedure ABI/TBI.
An ABI ≥ 0.90 is considered normal."|From baseline up to 30-days|Evaluable Ankle-brachial Index (ABI)/Toe brachial Index (TBI)result: missing data for 1 limb||limbs|Participants||Number
771888|NCT00730730|Secondary|Number of Limbs With Improvement Using Rutherford Scale to Determine Clinical Success.|"Improvement of Rutherford scale by ≥ 1 category between pre-procedure (Baseline) and 30-day follow-up-
Category 0: Asymptomatic, no hemodynamically significant occlusive disease;
Category 1: Mild claudication;
Category 2: Moderate claudication;
Category 3: Severe claudication;
Category 4: Ischemic rest pain;
Category 5: Minor tissue loss; non-healing ulcer; focal gangrene with diffuse pedal ischemia;
Category 6: Major tissue loss extending above transmetatarsal level;functional foot no longer salvageable"|From baseline up to 30-days|Analysis calculated using number of evaluable limbs with Rutherford results; data missing for two limbs||limbs|Participants||Number
771889|NCT00730730|Secondary|Number of Participants With Acute Success|angiographic evidence of < 30 % final residual stenosis of the target lesion after stent placement with no occurrence of a device- related, procedure-related MAE or vascular event (stent thrombosis, major bleeding complications)|from after stent placement to prior to hospital discharge (up to 3 days)|Intent to Treat population(ITT); missing angiographic data for one patient||participants|||Number
771890|NCT00730730|Primary|The Number of Participants With Major Adverse Events (MAE)|Major adverse events (MAE) defined as any death, target limb loss or clinically-driven Target Lesion Revascularization (TLR)/Target Vessel Revascularization (TVR) with percutaneous transluminal angioplasty or aorto-iliac bypass graft) for all subjects enrolled into the registry|30 days|Intent-to-treat population (ITT)||participants|||Number
771891|NCT00730756|Secondary|Mean Change From Baseline in AM and PM Reflective Individual Ocular Symptoms Over the Entire Treatment Period (28 Days)|Mean change for the individual symptoms of eye itching/burning, eye tearing/watering, and eye redeness. Reflective ratings assessed the participant's symptoms over the preceding 12 hours. Reflective assessments were performed twice daily (AM and PM) and were evaluated on a 0 (none) to 3 (severe) scale.|Baseline through Week 4 (28 days)|ITT Population||points on a scale||Standard Error|Least Squares Mean
784162|NCT00822900|Secondary|Disability Rating Scale|A measure of functional impairment, with complete recovery scored a 0 and vegetative state scored a 29.|6 months|||units on a scale||Standard Deviation|Mean
771892|NCT00730756|Secondary|Mean Change From Baseline in AM Pre-dose Instantaneous Individual Ocular Symptoms Over the Entire Treatment Period (28 Days)|The AM pre-dose instantaneous assessment is performed in the morning prior to dosing and evaluates symptoms at that moment. The individual symptoms of eye itching/burning, eye tearing/watering, and eye redness were measured at this time. All three symptoms were evaluated using a 0 (none) to 3 (severe) scale. This assessment provides information on the duration of action of the treatment.|Baseline through Week 4 (28 days)|ITT Population||points on a scale||Standard Error|Least Squares Mean
771893|NCT00730756|Secondary|Mean Change From Baseline in Daily Reflective Individual Ocular Symptoms Over the Entire Treatment Period (28 Days)|Mean change for the individual symptoms of eye itching/burning, eye tearing/watering, and eye redness. Reflective rating represents the participant's symptoms over the preceding 12 hours. Reflective assessments were performed twice daily (AM and PM). The average of the AM and PM reflective individual ocular symptoms is the daily reflective individual ocular symptoms. Reflective individual ocular symptoms were evaluated on a 0 (none) to 3 (severe) scale.|Baseline through Week 4 (28 days)|ITT Population||points on a scale||Standard Error|Least Squares Mean
771894|NCT00730756|Secondary|Mean Change From Baseline in Total Ocular Symptoms Over the Entire Treatment Period (28 Days)|The Total Ocular Symptom Score (TOSS) is a sum (scale 0-9) of the individual ocular scores for eye itching/burning, eye tearing/watering, and eye redness. All 3 symptoms were evaluated using a scale of 0 (None), 1 (Mild), 2 (Moderate), or 2 (Severe). The daily reflective TOSS (daily rTOSS) is the average of the morning (AM) and evening (PM) rTOSS assessments that measure symptoms over the previous 12 hours. The AM pre-dose instantaneous (iTOSS) assessment is performed in the morning prior to dosing and evaluates symptoms at that moment, providing data on the duration of action of treatment.|Baseline through Week 4 (28 days)|ITT Population||points on a scale||Standard Error|Least Squares Mean
771895|NCT00730756|Secondary|Mean Change From Baseline in AM and PM Reflective Individual Nasal Symptoms Over the Entire Treatment Period (28 Days)|Mean change for the individual symptoms of rhinorrhea, nasal congestion, and post-nasal drip as measured in the morning and evening. Reflective rating represents the participant's symptoms over the preceding 12 hours. All symptoms were evaluated on a 0 (none) to 3 (severe) scale.|Baseline through Week 4 (28 days)|ITT Population||points on a scale||Standard Error|Least Squares Mean
771896|NCT00730756|Secondary|Mean Change From Baseline in AM Pre-dose Instantaneous Individual Nasal Symptoms Over the Entire Treatment Period (28 Days)|The AM pre-dose instantaneous assessment is performed in the morning prior to dosing and evaluates symptoms at that moment. The individual symptoms of rhinorrhea, nasal congestion, and post-nasal drip were measured at this time. All three symptoms were evaluated using a 0 (none) to 3 (severe) scale. This assessment provides information on the duration of action of the treatment.|Baseline through Week 4 (28 days)|ITT Population||points on a scale||Standard Error|Least Squares Mean
771897|NCT00730756|Secondary|Mean Change From Baseline in Daily Reflective Individual Nasal Symptoms Score Over the Entire Treatment Period (28 Days)|Mean change for the individual symptoms of rhinorrhea, nasal congestion, and post-nasal drip. Reflective rating represents the participant's symptoms over the preceding 12 hours. Reflective assessments were performed in the morning (AM) and evening (PM). The daily reflective individual nasal symptom score average of the AM and PM reflective individual nasal symptoms is the daily reflective individual nasal symptom score. All symptoms were evaluated on a 0 (none) to 3 (severe) scale.|Baseline through Week 4 (28 days)|ITT Population||points on a scale||Standard Error|Least Squares Mean
771898|NCT00730756|Secondary|Mean Change From Baseline in AM rTNSS, PM rTNSS, and AM Pre-dose iTNSS Over the Entire Treatment Period (28 Days)|The TNSS is the Total Nasal Symptom Score (scale 0-9), a sum of the individual nasal scores for (1) rhinorrhea, (2) nasal congestion, and (3) post-nasal drip. All 3 symptoms were evaluated using a scale of: 0 (None), 1 (Mild), 2 (Moderate), or 3 (Severe). Reflective (r) assessments were performed in the morning (AM) and evening (PM) and assessed the participant's symptoms over the preceding 12 hours (AM rTNSS, PM rTNSS). The AM pre-dose instantaneous assessment (AM pre-dose iTNSS) was performed in the morning just prior to dosing and assessed symptoms at that moment.|Baseline through Week 4 (28 days)|ITT Population||points on a scale||Standard Error|Least Squares Mean
771899|NCT00730756|Primary|Mean Change From Baseline in Daily rTNSS Over the Entire Treatment Period (28 Days)|The Total Nasal Symptom Score (TNSS) is the sum (scale 0-9) of the individual nasal scores for rhinorrhea, nasal congestion, and post-nasal drip. All symptoms were evaluated using a scale of 0 (None), 1 (Mild), 2 (Moderate), or 3 (Severe). Reflective (r) assessments were performed in the morning (AM) and evening (PM) and assessed the participant's symptoms over the preceding 12 hours. The daily reflective Total Nasal Symptoms Score (daily rTNSS) is the average of the AM and PM rTNSS. Mean change from baseline was calculated as the participant's treatment period mean minus the baseline mean.|Baseline through Week 4 (28 days)|Intent-to-Treat (ITT) Population: all participants who received at least one dose of study medication||points on a scale||Standard Error|Least Squares Mean
771900|NCT00730847|Primary|Number of Subjects With Grade 3, Any and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Grade 3 SAE = SAE which prevented normal, everyday activities. Any was defined as occurrence of any symptom regardless of intensity grade and related was an event assessed by the investigator as causally related to the study vaccination.|Throughout the study period (up to Month 7).|The analysis was performed on the Total Vaccinated cohort which included all vacinated subjects for whom data were available.||subjects|||Number
771901|NCT00730847|Primary|Number of Subjects Reporting Any, Grade 3, Related and Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 = event which prevented normal, everyday activities. Related = event assessed by the investigators as causally related to the study vaccination. Grade 3 and Related = grade 3 event assessed by the investigators as causally related to the study vaccination.|During a 30-day (Days 0-29) post-vaccination period|The analysis was performed on the Total Vaccinated cohort which included all vacinated subjects for whom data were available.||subjects|||Number
774919|NCT00752986|Primary|Event Free Survival|Success rate (patients without progression and still on treatment at 24 weeks|Restaging (RECIST) is carried out at screening and every 3 months during the study until 1 year and than every 6 months until objective disease progression.||||||
771902|NCT00730847|Primary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms assessed were arthralgia, fatigue, fever, gastrointestinal, headache, myalgia, rash and urticaria. Any fever = axillary temperature ≥37.5 degrees Celsius (°C). For other symptoms: Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator as causally related to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 urticaria = urticaria distributed on at least 4 body areas. Grade 3 fever = axillary temperature >39.0°C.|During a 7-day follow-up period (Days 0-6) after any vaccination|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available and had the symptom sheet completed.||subjects|||Number
771903|NCT00730847|Primary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity grade. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness and swelling above 50 millimeters (mm).|During a 7-day follow-up period (Days 0-6) after any vaccination|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available and had the symptom sheet completed.||subjects|||Number
771904|NCT00730912|Primary|Mean Area Under the Plasma Concentration Time Curve (AUC) of SCH 29851 (Unchanged Drug), SCH 34117 (Active Metabolite), and SCH 45581 (3OH-SCH 34117)|SCH 29851: Two-compartment model used as basic pharmacokinetic (PK) model. Individual AUC estimated with basic PPK parameters (apparent total body clearance (CL/F), apparent distribution volumes of central compartment (Vc/F) and peripheral compartment (Vp/F), apparent inter-compartmental clearance (Q/F), absorption rate constant (Ka), lag time, inter- and intra-individual variation) by Bayesian method. SCH 34117/SCH 45581: One-compartment model used as basic PK model. Individual AUC was estimated with PPK parameters (above) on final model by Bayesian method.|After 2 and 4 weeks of treatment, and after 1 and 3 weeks of treatment if participant agreed|Number of participants for SCH 29851 were 53, 104, and 104. Number of participants for SCH 34117 were 53, 102, and 104. Number of participants for SCH 44581 were 53, 99, and 104.||ng•hr/mL||Standard Deviation|Mean
771905|NCT00730912|Primary|Mean Maximum Plasma Concentration (Cmax) of SCH 29851 (Unchanged Drug; Loratadine), SCH 34117 (Active Metabolite), and SCH 45581 (3OH-SCH 34117)|SCH 29851: Two-compartment model used as basic pharmacokinetic (PK) model. Individual Cmax estimated with basic PPK parameters (apparent total body clearance (CL/F), apparent distribution volumes of central compartment (Vc/F) and peripheral compartment (Vp/F), apparent inter-compartmental clearance (Q/F), absorption rate constant (Ka), lag time, inter- and intra-individual variation) by Bayesian method. SCH 34117/SCH 45581: One-compartment model used as basic PK model. Individual Cmax was estimated with PPK parameters (above) on final model by Bayesian method.|After 2 and 4 weeks of treatment, and after 1 and 3 weeks of treatment if participant agreed|Number of participants for SCH 29851 were 53, 104, and 104. Number of participants for SCH 34117 were 53, 102, and 104. Number of participants for SCH 44581 were 53, 99, and 104.||ng/mL||Standard Deviation|Mean
771906|NCT00730925|Secondary|Summary of Pre-dose Concentrations of Afatnib in Plasma|Pre-dose Concentrations of Afatinib in Plasma at Steady State on Days 15, 29 and 57 (Cpre,ss,15, Cpre,ss,29 and Cpre,ss,57)|Day 15, 29 and 57|Patients with no data available for the relevant parameter and dose were excluded from analysis.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
771907|NCT00730925|Secondary|Progression Free Survival (PFS) Time|PFS time defined as time from the start of treatment to the earliest of progression (RECIST), clinical progression (investigator), start of new anti-cancer treatment or death.|Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks thereafter.|Treated set (TS). TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.||Weeks||95% Confidence Interval|Median
771908|NCT00730925|Secondary|Percentage of Participants With Disease Control (DC)|Percentage of participants with OR or stable disease (SD) as determined by RECIST version 1.0.|Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks thereafter.|Treated set (TS). TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.||Percentage of participants||95% Confidence Interval|Number
771909|NCT00730925|Primary|Percentage of Participants With Best Objective Response|Percentage of participants with best objective response: confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.0.|Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks thereafter.|Treated set (TS). TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.||Percentage of participants||95% Confidence Interval|Number
771910|NCT00730964|Secondary|The Frequency of Overall Serious Adverse Events (SAE's) Among Subjects Who Receive Optison (Whether Related to the Product or Not) During Contrast Enhanced Echocardiography in Routine Clinical Practice.|The frequency of any serious adverse event (SAE) whether it is related to the Optison product or not, after the administration of the Optison product during contrast enhanced echocardiography.|Within 24 hours post contrast administration|||Serious adverse events|||Number
771911|NCT00730964|Primary|The Frequency of Serious Adverse Reactions (SAR)'s Among Subjects Who Receive Optison (Causally Related to the Product)During Contrast Enhanced Echocardiography in Routine Clinical Practice.|A Serious Adverse Reaction or (SAR) is considered causally related to the Optison product administered by the investigator. This reaction, should it occur, will be counted as a serious adverse reaction.|Within 24 hours post contrast administration|||Serious Adverse Reactions|||Number
771912|NCT00731042|Primary|Change From Baseline in Skin Health, Visual Skin Score (VSS) at 14 Days|Observe VSS score at 14 days, and graded change of skin health from baseline using scale of 0 (normal) - 5 (very scaly).|Baseline and 14 days|Analysis was done per protocol||units on a scale||Standard Deviation|Mean
771913|NCT00731055|Primary|Cigarette Choice|Over each of the four 6-hour experimental sessions, a participant was asked 9 times if they would take money or a cigarette. This outcome measure assesses the number of times a participant chose a cigarette.|During each of the four weekly 6-hour experimental sessions|||number of cigarette choices (0-9)||Standard Deviation|Mean
771914|NCT00731094|Secondary|Physical Function: 6MWD|Physical Function: 6MWD measured at Month 12|Month 12|||meters||Standard Deviation|Mean
784163|NCT00822900|Secondary|Mortality||6 months|||participants|||Number
771917|NCT00731094|Secondary|HRQL: SF-36 MCS|HRQL: SF-36 MCS measured at Month 12. The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The 8 scales are the weighted sums of the 2-10 questions in their section. Norm-based scoring, where each scale and component summary measures were scored to have the same average (50) and the same standard deviation (10 points), was used for reporting results in this study. Scores are interpreted as the lower the score the more disability; conversely, the higher the score the less disability. The MCS aggregates the scales for vitality, mental health, social functioning, and role limitations due to personal or emotional problems.|Month 12|||scores on a scale||Standard Deviation|Mean
771918|NCT00731094|Secondary|HRQL: SF-36 MCS|HRQL: SF-36 MCS measured at Month 6. The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The 8 scales are the weighted sums of the 2-10 questions in their section. Norm-based scoring, where each scale and component summary measures were scored to have the same average (50) and the same standard deviation (10 points), was used for reporting results in this study. Scores are interpreted as the lower the score the more disability; conversely, the higher the score the less disability. The MCS aggregates the scales for vitality, mental health, social functioning, and role limitations due to personal or emotional problems.|Month 6|||scores on a scale||Standard Deviation|Mean
771919|NCT00731094|Secondary|HRQL: SF-36 Mental Component Summary Measure (MSC)|HRQL: SF-36 MCS measured at Month 0. The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The 8 scales are the weighted sums of the 2-10 questions in their section. Norm-based scoring, where each scale and component summary measures were scored to have the same average (50) and the same standard deviation (10 points), was used for reporting results in this study. Scores are interpreted as the lower the score the more disability; conversely, the higher the score the less disability. The MCS aggregates the scales for vitality, mental health, social functioning, and role limitations due to personal or emotional problems.|Month 0|||scores on a scale||Standard Deviation|Mean
771920|NCT00731094|Secondary|HRQL: SF-36 PCS|HRQL: SF-36 PCS measured at Month 12. The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The 8 scales are the weighted sums of the 2-10 questions in their section. Norm-based scoring, where each scale and component summary measures were scored to have the same average (50) and the same standard deviation (10 points), was used for reporting results in this study. Scores are interpreted as the lower the score the more disability; conversely, the higher the score the less disability. The PCS aggregates the scales for bodily pain, general health perceptions, physical functioning, and role limitation due to physical health problems.|Month 12|||scores on a scale||Standard Deviation|Mean
771921|NCT00731094|Secondary|HRQL: SF-36 PCS|HRQL: SF-36 PCS measured at Month 6. The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The 8 scales are the weighted sums of the 2-10 questions in their section. Norm-based scoring, where each scale and component summary measures were scored to have the same average (50) and the same standard deviation (10 points), was used for reporting results in this study. Scores are interpreted as the lower the score the more disability; conversely, the higher the score the less disability. The PCS aggregates the scales for bodily pain, general health perceptions, physical functioning, and role limitation due to physical health problems.|Month 6|||scores on a scale||Standard Deviation|Mean
771922|NCT00731094|Secondary|Health Related Quality of Life (HRQL): Short Form 36 Health Survey Questionnaire (SF-36) Physical Component Summary Measure (PCS)|HRQL: SF-36 PCS measured at Month 0. The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The 8 scales are the weighted sums of the 2-10 questions in their section. Norm-based scoring, where each scale and component summary measures were scored to have the same average (50) and the same standard deviation (10 points), was used for reporting results in this study. Scores are interpreted as the lower the score the more disability; conversely, the higher the score the less disability. The PCS aggregates the scales for bodily pain, general health perceptions, physical functioning, and role limitation due to physical health problems.|Month 0|||scores on a scale||Standard Deviation|Mean
771923|NCT00731094|Secondary|Triglycerides|Triglycerides measured at Month 12|Month 12|||mg/dL||Standard Deviation|Mean
771924|NCT00731094|Secondary|Triglycerides|Triglycerides measured at Month 6|Month 6|||mg/dL||Standard Deviation|Mean
771925|NCT00731094|Secondary|Triglycerides|Triglycerides measured at Month 0|Month 0|||mg/dL||Standard Deviation|Mean
771926|NCT00731094|Secondary|HDL Cholesterol|HDL cholesterol measured at Month 12|Month 12|||mg/dL||Standard Deviation|Mean
771927|NCT00731094|Secondary|HDL Cholesterol|HDL cholesterol measured at Month 6|Month 6|||mg/dL||Standard Deviation|Mean
771928|NCT00731094|Secondary|High-density Lipoprotein (HDL) Cholesterol|HDL cholesterol in milligrams/deciliter (mg/dL) measured at Month 0|Month 0|||mg/dL||Standard Deviation|Mean
771929|NCT00731094|Secondary|LDL Cholesterol|LDL cholesterol measured at Month 12|Month 12|||mg/dL||Standard Deviation|Mean
771930|NCT00731094|Secondary|LDL Cholesterol|LDL cholesterol measured at Month 6|Month 6|||mg/dL||Standard Deviation|Mean
771931|NCT00731094|Secondary|Low-density Lipoprotein (LDL) Cholesterol|LDL cholesterol in milligrams per deciliter (mg/dL) measured at Month 0|Month 0|||mg/dL||Standard Deviation|Mean
771932|NCT00731094|Secondary|Diastolic BP|Diastolic BP measured at Month 12|Month 12|||mmHg||Standard Deviation|Mean
771933|NCT00731094|Secondary|Diastolic BP|Diastolic BP measured at Month 6|Month 6|||mmHg||Standard Deviation|Mean
771934|NCT00731094|Secondary|Diastolic BP|Diastolic BP measured at Month 0|Month 0|||mmHg||Standard Deviation|Mean
771935|NCT00731094|Secondary|Systolic BP|Systolic BP measured at Month 12|Month 12|||mmHg||Standard Deviation|Mean
771941|NCT00731094|Primary|Moderate Intensity Physical Activity: Accelerometer|Participants with an average of at least 30 minutes/day of moderate intensity or greater physical activity in a subset of the study population for whom accelerometer data were obtained: 71 of 98 in Physical Activity Intervention Group and 74 of 105 in Attention Control Group at Month 12|Month 12|||participants|||Number
771942|NCT00731094|Primary|Moderate Intensity Physical Activity: Accelerometer|Participants with an average of at least 30 minutes/day of moderate intensity or greater physical activity in a subset of the study population for whom accelerometer data were obtained: 77 of 101 in Physical Activity Intervention Group and 76 of 107 in Attention Control Group in Month 6|Month 6|||participants|||Number
771943|NCT00731094|Primary|Moderate Intensity Physical Activity: Accelerometer|Participants with an average of at least 30 minutes/day of moderate intensity or greater physical activity in a subset of the study population for whom accelerometer data were obtained: 97 of 116 in Physical Activity Intervention Group and 103 of 116 in Attention Control Group at Month 0|Month 0|||participants|||Number
771944|NCT00731094|Primary|Moderate Intensity Physical Activity: Modified CHAMPS Questionnaire|Participants achieving 150 minutes/week of moderate intensity or greater physical activity at Month 12 as measured with the modified CHAMPS Questionnaire|Month 12|||participants|||Number
771945|NCT00731094|Primary|Moderate Intensity Physical Activity: Modified CHAMPS Questionnaire|Participants achieving 150 minutes/week of moderate intensity or greater physical activity at Month 6 as measured with the modified CHAMPS Questionnaire|Month 6|||participants|||Number
771946|NCT00731094|Primary|Moderate Intensity Physical Activity: Modified Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire|Participants achieving 150 minutes/week of moderate intensity or greater physical activity at Month 0 as measured with the modified CHAMPS Questionnaire|Month 0|||participants|||Number
771947|NCT00731120|Secondary|Health Care Resource Utilization Assessed by the Health Economic Assessment Questionnaire|Healthcare resource utilization was assessed by the Health Economic Assessment (HEA) questionnaire, which monitors participants absenteeism from work, as well as resource use such as visits to a general practitioner, outpatient and inpatient services, hospitalization, medications, and other relevant services over the past 8 weeks.|Baseline and Week 8|Full analysis set||participants|||Number
771948|NCT00731120|Secondary|Change From Baseline in 36-item Short-form Health Survey (SF-36)|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The 8 health concepts are: 1. Limitation in physical activities because of health problems. 2. Limitations in usual role activities because of physical health problems. 3. Bodily pain. 4. Limitations in social activities because of physical or emotional problems. 5. General mental health (psychological distress and well-being). 6. Limitations in usual role activities because of emotional problems. 7. Vitality (energy and fatigue). 8. General health perception. Each scale ranges from 0 (best) - 100 (worst). LS means were from an ANCOVA model with treatment and center as fixed factors and the baseline value as a covariate.|Baseline and Week 8|Full analysis set with a Baseline SF-36 measurement; LOCF was used.||scores on a scale||Standard Error|Least Squares Mean
771949|NCT00731120|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) at Week 8|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Week 8|Full analysis set with available data at Baseline; LOCF was used.||scores on a scale||Standard Error|Least Squares Mean
771950|NCT00731120|Secondary|Change From Baseline in Hospital Anxiety and Depression (HAD) Scales|The HAD scale is completed by the participant and comprises two subscales, one measuring depression (focusing on the state of lost interest and diminished pleasure response) and one measuring anxiety (including anxious mood, restlessness, anxious thoughts, panic attacks). Each subscale is made up of 7 items that are assessed on a scale of 0 = no anxiety/depression to 3 = severe feeling of anxiety/depression. Participants are required to indicate the response which most accurately reflects the way they have felt over the last few days. Scores for the depression and anxiety subscales are summed separately and not combined, with each score ranging from 0 to 21 (maximal severity). LS means were from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Weeks 1, 4 and 8.|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Deviation|Mean
771951|NCT00731120|Secondary|Change From Baseline in Clinical Global Impression Scale-Severity of Illness (CGI-S)|The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the participant's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. LS means were from an ANCOVA model adjusting for Baseline score, center, and treatment.|Baseline and Weeks 1, 2, 4, 6 and 8.|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
771952|NCT00731120|Secondary|Clinical Global Impression Scale-Global Improvement (CGI-I) at Each Week Assessed|The Clinical Global Impression - Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from an ANCOVA model adjusting for Baseline CGI-S score, center, and treatment.|Baseline and Weeks 1, 2, 4, 6 and 8.|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
771953|NCT00731120|Secondary|Percentage of Participants in HAM-A Remission at Week 8|Remission is defined as a Hamilton Anxiety Scale (HAM-A) total score ≤ 7. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity).|Week 8|Full analysis set; LOCF was used.||percentage of participants|||Number
771954|NCT00731120|Secondary|Percentage of Responders in HAM-A Total Score at Week 8|Response was defined as a participant with a ≥50% decrease from Baseline in the HAM-A total score. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity).|Baseline and Week 8|Full analysis set; LOCF was used.||percentage of participants|||Number
771955|NCT00731120|Secondary|Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. LS means were from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Weeks 1, 2, 4 and 6|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
771956|NCT00731120|Primary|Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Least Squares (LS) means were from an analysis of covariance (ANCOVA) model with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Week 8|The full analysis set (FAS) included all randomized patients who received at least 1 dose of study drug, and had at least 1 post-baseline value for assessment of primary efficacy. Last observation carried forward (LOCF) was used.||scores on a scale||Standard Error|Least Squares Mean
771957|NCT00731133|Secondary|Proportion of Amphetamine-positive Urine Samples|the proportion of urine samples positive for amphetamine. Data were entered into a mixed model ANOVA in order to determine whether scores significantly changed over time. A slope and standard deviation describing this change over time were generated and used as our outcome measures.|thrice weekly for 6 weeks|Only data from participants who received more than one dose of disulfiram were analyzed. Of the 15 participants who entered the study, one participant received only one dose so data from 14 participants were analyzed.||proportion of urines positive for amphet||Standard Deviation|Least Squares Mean
771958|NCT00731133|Primary|Side Effects Checklist|It consists of 25 items describing side effects specific to disulfiram alone or combined with alcohol or cocaine that are rated on a scale from 0 (not at all) to 4 (very much). Total scores range from 0 (minimum) to 100 (maximum). Data were entered into a mixed model ANOVA in order to determine whether scores significantly changed over time. A slope and standard deviation describing this change over time were generated and used as our outcome measures.|Weekly for six weeks|Those who received more than one dose of disulfiram and/or completed more than one set of assessments during the protocol. Of the 15 participants who entered the study, one participant only attended clinic one day and so data were analyzed for 14 participants.||units on a scale||Standard Deviation|Least Squares Mean
771959|NCT00731198|Secondary|Side Effects||Intra-procedure and 24 hours after ERCP||||||
771960|NCT00731198|Secondary|Frequency of Post-ERCP Complications||48 hours after ERCP||||||
771961|NCT00731198|Secondary|Percentage of Successful Selective Cannulation||Intra-procedure||||||
771962|NCT00731198|Secondary|Cannulation Time||Intra-procedure||||||
771963|NCT00731198|Primary|The Grades of the Number of Duodenal Contractions|a duodenal motility grade was determined as follows: 0 = no motility; 1 = less than five contractions/minute; 2 = 5 to 10/minute; 3 = 11 to 15/minute; 4 = continuous.|Intra-procedure|||scores on a scale||Standard Deviation|Mean
771964|NCT00731211|Secondary|Progression-free Survival|Progression-free survival is measured from Day 1 of study drug administration to disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death on study. Progression is defined in RECIST v1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|every 8 weeks until progressive disease, expected average of 18 months|||months||95% Confidence Interval|Median
771965|NCT00731211|Primary|Overall Response Rate|Proportion of patients with complete and partial response (CR and PR). CR defined as disappearance of target lesions; PR defined as at least a 30% decrease in the sum of the longest diamater of target lesions.|18 months|||percentage of patients||95% Confidence Interval|Number
771966|NCT00731341|Secondary|Physician's Satisfaction From the Ease and Convenience of the Cryoablation Procedure|Physician's satisfaction from the ease and convenience of the cryoablation procedure using a scale of 1 (very satisfied) to 5 (very dissatisfied).|Post procedure|||Score from 1 to 5||Full Range|Mean
771967|NCT00731341|Secondary|Evaluation of Length of an Average Cryoablation Procedure|Evaluation of length of an average cryoablation procedure for the treatment of uterine fibroids|Post procedure|||Minutes||Full Range|Mean
771968|NCT00731341|Secondary|Number of Participants Discharged on Day of Cryoablation Procedure.|Per the protocol, this outcome intended to report the average duration of post operative hospital stay. However, this measurement was made very generally and was not collected in number of hours, only the dates were collected. The only actual data that can be stated is that all subjects were discharged from the hospital on the same day as the procedure. In order to report the average length of hospital stay, the wording on the outcome measure title has been changed.|Post procedure|||Participants|||Number
771969|NCT00731341|Secondary|Time (in Days) to Return to Normal Activity|The number of days needed to return to normal activity was assessed by the participant and reported to the investigator. The response was documented at follow-up.|4 weeks post procedure|||Days||Full Range|Mean
771970|NCT00731341|Secondary|Hysteroscopic Cryoablation Related Pain Will be Measured by Self Reported Pain Severity Visual Analogue Scale (VAS) Completed by the Patient|Hysteroscopic cryoablation related pain will be measured by self reported pain severity Visual Analogue Scale (VAS) from a scale of 1 (no pain) to 10 (very severe pain) completed by the patient|Prior to hospital discharge (less than 24 hours post-procedure)|||Units on a scale from 1 to 10||Full Range|Mean
771971|NCT00731341|Primary|Number of Adverse Events|Safety of the procedure will be assessed by incidence and severity of intra and post procedure related adverse events (AEs)|up to 4 weeks post procedure.|||Participants|||Number
771972|NCT00731484|Primary|Tear Osmolarity in Human Measured by TearLab System|Tear osmolarity was measured with a laboratory-on-a-chip, which simultaneously collects and analyzes the electrical impedance of a 50 nL tear sample from the inferior lateral meniscus (TearLab Osmolarity System). The results are reported in mOsm/L. The trial was not set up to evaluate diagnostic performance, as no gold-standard method was used to establish dry eye status, but rather, to determine whether the TearLab could measure tear osmolarity in human subjects.|Single visit, at time of tear osmolarity testing.|Healthy normal volunteers as well as subjects diagnosed with moderate or severe chronic dry eye disease and/or Sjögrens Syndrome||mOsms/L||Full Range|Mean
771973|NCT00731549|Secondary|Percentage of Participants Who Discontinued Due to All Causes.|Participants who discontinued due to any cause were noted. Limited concurrent treatment with oral aripiprazole was permitted as rescue therapy.|Baseline to Week 52|All participants who entered Phase 3 and have at least one post-baseline efficacy evaluation in Phase 3 are included.||Percentage of participants|||Number
771974|NCT00731549|Secondary|Mean Clinical Global Impression of Improvement (CGI-I) Score.|To assess CGI-I the rater or physician will rate the participant's total improvement whether or not it is due entirely to drug treatment. All responses will be compared to the participants condition at baseline. Response choices include: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.|Weeks 2, 4, 12, 24, 52 and last visit|All participants who entered Phase 3 and have at least one post-baseline efficacy evaluation in Phase 3 are included. Number of participants analyzed with baseline or at least one postbaseline assessment are included here.||Units on a scale||Standard Deviation|Mean
771975|NCT00731549|Secondary|Mean Change From Baseline to Endpoint in PANSS Positive and Negative Subscales.|PANSS positive subscale score (range 7-49) is the sum of the rating scores for the 7 positive scale items from the PANSS scale. Positive subscale consists of 7 positive symptom constructs: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility). PANSS negative subscale score (range 7-49) is the sum of the rating scores for the 7 negative scale items from the PANSS scale. Negative subscale consists of 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive pathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking). The severity of each scale is rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms.|Baseline, Weeks 12, 24, 52 and last visit|All participants who entered Phase 3 and have at least one post-baseline efficacy evaluation in Phase 3 are included. Number of participants analyzed with baseline or at least one postbaseline assessment are included here.||Units on a scale||Standard Deviation|Mean
771976|NCT00731549|Secondary|Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score.|To assess CGI-S, the rater or physician will answer the following question: “Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?” Response choices include: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.|Baseline, Weeks 12, 24, 52 and last visit|All participants who entered Phase 3 and have at least one post-baseline efficacy evaluation in Phase 3 are included. Number of participants analyzed with baseline or at least one postbaseline assessment are included here.||Units on a scale||Standard Deviation|Mean
771977|NCT00731549|Secondary|Mean Change From Baseline to Endpoint (Last Visit) in Positive and Negative Syndrome Scale (PANSS) Total Score.|PANSS total score (range 30-210) is the sum of the rating scores for 7 positive scale items, 7 negative scale items and 16 general psychopathology scale items from the PANSS scale. PANSS positive subscale score (range 7-49) is the sum of the rating scores for the 7 positive scale items from the PANSS scale. PANSS negative subscale score (range 7-49) is the sum of the rating scores for the 7 negative scale items from the PANSS scale. The severity of each scale is rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms.|Baseline, Weeks 12, 24, 52 and last visit|All participants who entered Phase 3 and have at least one post-baseline efficacy evaluation in Phase 3 are included. Number of participants analyzed with baseline or at least one postbaseline assessment are included here.||Units on a scale||Standard Deviation|Mean
771978|NCT00731549|Secondary|Percentage of Participants With Time to First Exacerbation of Psychotic Symptoms/Impending Relapse.|Participants who first time meet relapse criteria were considered as having an event at date of exacerbation of psychotic symptoms/impending relapse. Time to first event was calculated as the earliest date of meeting one of relapse criteria. Limited concurrent treatment with oral aripiprazole was permitted as rescue therapy.|Baseline to Week 52|All participants who entered Phase 3 and have at least one post-baseline efficacy evaluation in Phase 3 are included. Number of participants analyzed had available assessments for evaluation of exacerbation of psychotic symptoms/impending relapse.||Percentage of participants|||Number
785433|NCT00836641|Secondary|Number of Vaccinees With Adverse Events|we evaluated the safety and tolerability of sequential pneumococcal immunization as to local and systemic adverse events.|12 months|||participants|||Number
771979|NCT00731549|Secondary|Percentage of Participants Stable at Baseline and Remaining Stable at Week 28.|"Stable was defined as meeting all of the following criteria: Outpatient status; PANSS total score ≤ 80; Lack of specific psychotic symptoms on the PANSS as measured by a score of ≤ 4 on each of the following items (possible scores of 1 to 7 for each item): 1) conceptual disorganization 2) suspiciousness 3) hallucinatory behavior 4) unusual thought content; Clinical Global Impression of Severity (CGI-S) ≤ 4 (moderately ill); and Clinical Global Impression for Severity of Suicidality (CGI-SS) ≤ 2 (mildly suicidal) on Part 1 and ≤ 5 (minimally worsened) on Part 2. The percentage of stable participants at baseline who remain stable at Week 28 is described here."|Baseline to Week 28|All participants who entered Phase 3 and have at least one post-baseline efficacy evaluation in Phase 3 are included. N defines number of stable participants at baseline who were evaluated at the specified trial week.||Percentage of participants|||Number
771980|NCT00731549|Secondary|Percentage of Participants Achieving Remission.|Remission is defined as a score of ≤ 3 on each of the following specific PANSS items, maintained for a period of six months: delusions, unusual thought content, hallucinatory behavior, conceptual disorganization, mannerisms/posturing, blunted affect, social withdrawal, and lack of spontaneity.|Overall remission from Weeks 2,4,8,12,16,20,24,28,32,36,40,44,48 and 52|All participants who entered Phase 3 and have at least one post-baseline efficacy evaluation in Phase 3 are included. N defines number of participants evaluated at the specified trial week.||Percentage of participants|||Number
771981|NCT00731549|Secondary|Percentage of Participants Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria.|"Impending relapse criteria was defined as meeting all the following criteria: 1) Clinical Global Impression of Improvement (CGI-I) ≥ 5 (minimally worse), AND an increase to score of >4 and absolute increase of ≥ 2 on the individual PANSS items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content); or an increase to score >4 and absolute increase of ≥ 4 on the combined 4 PANSS items on any of these PANSS items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content) OR 2) Hospitalization due to worsening of psychotic symptoms, but excluding hospitalization for psychosocial reasons, OR 3) CGI-SS score of 4 (severely suicidal) or 5 (attempted suicide) on Part 1 and/or 6 (much worse) or 7 (very much worse) on Part 2, OR 4) Violent behavior resulting in clinically relevant self-injury, injury to another person, or property damage."|Weeks 2,4,8,12,16,20,24,28,32,36,40,44,48,52, and Last visit (upto 4 weeks ± 3 days after completion or withdrawal)|All participants who entered Phase 3 and have at least one post-baseline efficacy evaluation in Phase 3 are included. N defines number of participants evaluated at the specified trial week.||Percentage of participants|||Number
771982|NCT00731549|Primary|Percentage of Stable Participants at Baseline Who Remained Stable at Endpoint (Last Visit).|"Stable was defined as meeting all of the following criteria: Outpatient status; Positive and negative syndrome scale (PANSS) total score ≤ 80; Lack of specific psychotic symptoms on the PANSS as measured by a score of ≤ 4 on each of the following items (possible scores of 1 to 7 for each item): 1) conceptual disorganization 2) suspiciousness 3) hallucinatory behavior 4) unusual thought content; Clinical Global Impression of Severity (CGI-S) ≤ 4 (moderately ill); and Clinical Global Impression for Severity of Suicidality (CGI-SS) ≤ 2 (mildly suicidal) on Part 1 and ≤ 5 (minimally worsened) on Part 2. The percentage of stable participants at baseline who remain stable at endpoint (last visit) is described here."|Baseline to Week 52/Last visit|All participants who entered Phase 3 and have at least one post-baseline efficacy evaluation in Phase 3 are included. N defines number of stable participants at baseline who were evaluated at the specified trial week.||Percentage of participants|||Number
771983|NCT00731614|Secondary|SF-12|the SF-12 is a standardized self-report questionnaire that assesses mental and physical functioning.|Baseline, end of treatment, 12 weeks posttreatment, 24 weeks posttreatment||06/2015||||
771984|NCT00731614|Primary|Phantom Limb Pain Questionnaire|The primary outcome measure is the severity of phantom limb pain on a likert scale from 0 (no pain) to 10 (worst pain imaginable)|Baseline, each weekly treatment session (1-8), 12 weeks post treatment, 24 weeks posttreatment.|Data analyzed for participants with complete data for all assessments using repeated measure ANOVA.||units on a scale||Standard Error|Mean
771985|NCT00731640|Secondary|Spectacle Independence|The percentage of patients reporting spectacle independence (no longer needing to wear glasses).|6 Months|||Percentage of Participants|||Number
771986|NCT00731640|Secondary|Patient Satisfaction|Average rating of patient satisfaction based on a patient survey. The survey had a 10 point scale (10 being most satisfied and 0 being most unsatisfied).|6 Months Postoperative|||Units on a Scale||Standard Deviation|Mean
771987|NCT00731640|Secondary|Contrast Sensitivity|Contrast sensitivity is the measurement of one's ability to detect slight changes in luminance before it becomes indistinguishable. It is measured in logarithmic (log) units by means of an illuminated box, the CSV 1000 by Vector Vision. A higher value for the logarithmic units translates to better contrast sensitivity.|6 Months|||Log Units||Standard Deviation|Mean
771988|NCT00731640|Primary|Visual Acuity|Uncorrected Visual Acuity (VA) is measured in logMAR. LogMAR is the “logarithm of the minimum angle of resolution”. A lower logMAR value indicates better visual acuity.|6 months|||LogMar||Standard Deviation|Mean
771989|NCT00731653|Primary|The Primary Safety and Tolerability Outcome Measure is Reported Adverse Events.||Weeks 0-6 (study treatment) and Weeks 7 and 8 (post-treatment)|All patients who received at least one dose of study treatment during the extension phase were included in the analysis population. Analyses were performed with observed data. Tables and listings of safety and efficacy assessments will include all data observed. There was no imputation or adjustment for missing data values.||participants|||Number
771990|NCT00731666|Secondary|The Rate of Change in Male Stress Urinary Incontinence(SUI).|"Subject responses to 3 questions were evaluated:
On average, how many of these (pads, tissues, disposable undergarments) would you use to protect against wetness during the day?
Overall, how often have you needed to change your daily activities because of urinary incontinence?
Overall, how big of a social problem has urinary incontinence been for you during the past month?"|12 months|||percentage of participants|||Number
771991|NCT00731666|Secondary|Assess Participant Satisfaction With the Penile Length at Baseline, 12 and 24 Months Post Implantation Via Participant Questionaire.||12 and 24 months|Subjects implanted with Titan IPP||percentage of participants|||Number
771992|NCT00731666|Primary|The Study's Primary Objective Will Assess the Change in Penile Length.||12 months|||cm||Standard Deviation|Mean
771993|NCT00731679|Secondary|Proportion of Subjects Who Had Adequate Relief of IBS-related Bloating for at Least 2 of the 4 Weeks During the Primary Evaluation Period (ie, Weeks 3 Through 6).|"The secondary outcome measure is assessed during the 4-week period (ie, Weeks 3 through 6) immediately following 2 weeks of treatment with study drug. Adequate relief of bloating was defined as a response of yes to the following question, which was asked weekly (every 7 days): In regard to your symptom of bloating, as compared to the way you felt before you started study medication, have you, in the past 7 days, had adequate relief of your IBS symptom of bloating? [Yes/No]."|4 weeks|The analysis population was the intent-to-treat population, defined as subjects who received at least 1 dose of study drug.||percentage of responders|||Number
771994|NCT00731679|Primary|Proportion of Subjects Who Had Adequate Relief of Global IBS Symptoms for at Least 2 of the 4 Weeks During the Primary Evaluation Period (ie, Weeks 3 Through 6).|"The primary outcome measure is assessed during the 4-week period (ie, Weeks 3 through 6) immediately following 2 weeks of treatment with study drug. Adequate relief of global IBS symptoms was defined as a response of yes to the following question, which was asked weekly (every 7 days): In regard to all your symptoms of IBS, as compared to the way you felt before you started study medication, have you, in the past 7 days, had adequate relief of your IBS symptoms? [Yes/No]"|4 weeks|The analysis population was the intent-to-treat population, defined as subjects who received at least 1 dose of study drug.||percentage of responders|||Number
771995|NCT00731692|Secondary|Change in MSFC Z-score and Subscale Scores From Baseline to Month 36|The Multiple Sclerosis Functional Composite (MSFC) is a multidimensional clinical outcome measure that includes quantitative tests of leg function/ambulation (Timed 25-Foot Walk), arm function (9-Hole Peg Test), and cognitive function (Paced Auditory Serial Addition Test). The overall MSFC z-score as an average of the three standardized scores derived using baseline data pooled over each treatment arm as reference population. Higher scores reflect better neurological function and a positive change from Baseline indicates improvement.|Baseline to Month 36|Full analysis set (FAS) - The main efficacy analyses were performed using the FAS||Z-scores||Standard Deviation|Mean
771996|NCT00731692|Secondary|Blood Concentrations of Fingolimod and Fingolimod-phosphate|"Concentrations of fingolimod and fingolimod-phosphate in whole blood were determined by validated liquid chromatography methods with tandem mass spectrometry. The lower limits of quantification were 0.08 ng/ml for fingolimod and 0.1 ng/ml for fingolimod-phosphate.
Venous blood samples were collected for the analysis."|Month 3 up to 36 months|Full analysis set (FAS) -The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo. (N). Only participants (n) who provided one or more evaluable blood concentration were included in the pharmacokinetic analysis population. Analysis include 147 patients (cohort 1)||ng/ml||Standard Deviation|Mean
771997|NCT00731692|Secondary|Change From Baseline in Multiple Sclerosis Walking Scale (MSWS-12 Score)|The Multiple Sclerosis Walking Scaleis a patient reported measure of walking quality (Hobart et al 2003), consisting of 12 items asking patients to rate the impact of MS upon their walking ability. Responses were captured on a 3-point scale ranging from 1 (Not at all) to 3 (A lot) for items 1 to 3 and on a 5-point scale ranging from 1 (not limited) to 5 (extremely) for items 4 to 12. All 12 item scores were summed to obtain a total score ranging from 12 (good) to 54 (poor) which is the MSWS-12 scale score. The total score was transformed to a 0 to 100 scale score. The MSWS-12 scale score will be transformed to a 0-100 scale score before any summaries or statistical analyses are performed. The transformed score is obtained by subtracting 12 and divided by 42 and multiplying by 100 (i.e., transformed scale score = (raw scale score- 12)/42*100).|Baseline, 36 months|Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo. Only subjects with a value at both baseline and at month 36 are included.||Score on a scale||Standard Deviation|Mean
771998|NCT00731692|Secondary|Change From Baseline in European Quality of Life – 5 Dimensions (EQ-5D Score)|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, 36 months|Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo. Only subjects with a value at both baseline and at month 36 are included.||Score on a scale||Standard Deviation|Mean
771999|NCT00731692|Secondary|Change From Baseline in Unidimensional Fatigue Impact (U-FIS) Score|Unidimensional Fatigue Impact Scale (U-FIS), contains 22 patient-reported items that assess the impact of fatigue on cognitive, physical, and psychosocial functioning. Responses formed a single unidimensional scale measuring fatigue impact. The U-FIS was calculated and analyzed according to the U-FIS scoring manual. The U-FIS scale contains 22 items with 5 possible outcomes for each item. Two response categories (about half the time and a lot of the time) were combined into 1 category to obtain 4 possible outcomes: 0 (never), 1 (a little of the time), 2 (about half the time/a lot of the time), and 3 (all the time). The 22 condensed item scores were summed to obtain a total score ranging from 0 (no fatigue) to 66 (severe fatigue impact).|Baseline, 36 months|Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo. Only subjects with a value at both baseline and at month 36 are included.||Score on a scale||Standard Deviation|Mean
772000|NCT00731692|Secondary|Change From Baseline in PRIMUS-Activities|The activities subscale of PRIMUS contains 15 items and each item is given a score of 0 (able to do on own without difficulties), 1 (able to do on own with difficulties), or 2 (unable to do on own). All 15 items were summed to obtain a total score ranging from 0 (good) to 30 (poor).|Baseline, 36 months|Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo. Only subjects with a value at both baseline and at month 36 are included.||Score on a scale||Standard Deviation|Mean
772056|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 9|Subject Satisfaction - would you recommend this penile implant device to men with the same erectile difficulty that you had?|3 months post-surgery|||"% responding yes and probably"|||Number
772057|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 8|Subject Satisfaction - length when inflated|12 months post-surgery|||% satisfactory or somewhat satisfactory|||Number
772001|NCT00731692|Secondary|Change From Baseline in the Patient Reported Indices in Multiple Sclerosis (PRIMUS-QoL Score)|The quality of life scale contains 22 items. Each item will be given a score of 1 or 0. A score of 1 (or 0) indicates the presence (or absence) of the symptom or adverse quality of life. All 22 item scores will be summed to obtain a total score ranging from 0 (good) to 22 (poor), which is the PRIMUS QoL scale score|Baseline, 36 months|Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo. Only subjects with a value at both baseline and at month 36 are included.||Score on a scale||Standard Deviation|Mean
772002|NCT00731692|Secondary|Percent Change in Total T2 Lesion Volume From Baseline to Month 36|Inflammatory disease as measured by percent change in total T2 lesion volume (mm3) was assessed by MRI. N= Total number of patients included in the analysis|Baseline to month 36|Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo.||Percent Change||Standard Deviation|Mean
772003|NCT00731692|Secondary|Number of Gd-enhancing Lesions at Month 36|Inflammatory disease, as measured by number of T1 Gd-enhancing lesions, was assessed by MRI scanning of the brain and full spinal cord. N= Total number of patients included in the analysis|Baseline to 36 months|Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo.||Gd-enhanced lesions per patient per scan||95% Confidence Interval|Least Squares Mean
772004|NCT00731692|Secondary|Number of New/Enlarging T2 Lesions Per Year Measured From Baseline to Month 36|Inflammatory disease, as measured by number of new or newly-enlarging T2 lesions, was assessed by Magnetic resonance Imaging (MRI) scanning of the brain and full spinal cord. N= Total number of patients included in the analysis|Baseline to 36 months|Full analysis set (FAS) -The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo.||T2 Lesions per year||95% Confidence Interval|Least Squares Mean
772005|NCT00731692|Secondary|Kaplan Meier Estimate -Percentage of Participants With 3- Month Confirmed Disability Progression Based on 25' TWT.|The 25' TWT is a quantitative measure of lower extremity function designed and validated for evaluation of MS patients. N= Total number of patients included in the analysis|up to 36 months after the last patient was randomized|Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo.||Percentage of Participants|||Number
772006|NCT00731692|Secondary|Kaplan Meier Estimate -Percentage of Participants With 3- Month Confirmed Disability Progression Based on 9-HPT.|The 9-HPT is a quantitative measure of upper extremity (arm and hand) function designed and validated for evaluation of MS patients. N= Total number of patients included in the analysis|up to 36 months after the last patient was randomized|Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo.||Percentge of Participants|||Number
772007|NCT00731692|Secondary|Percent Change From Baseline in Brain Volume at Month 36|The percent change from Baseline in brain volume was analyzed using a random coefficients model. The model included: 1) fixed effects: treatment and region and 2) continuous covariates: time, number of Gd enhancing lesions at Baseline, Baseline T2 volume, and normalized brain volume at Baseline. Time as a continuous covariate allowed for the estimation of different slopes and intercepts among treatment groups.|Baseline to month 36|Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo. N= Total number of patients included in the analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
772008|NCT00731692|Secondary|Kaplan-Meier Estimate of the Risk of 3- Month Confirmed Disability Progression Based on Expanded Disability Status Scale (EDSS)|The Expanded Disability Status Scale (EDSS) is a scale for assessing neurologic impairment in MS (Kurtzke 1983) and includes a series of scores in each of 8 functional systems and the EDSS steps (ranging from 0 (normal) to 10 (death due to MS)). The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions. Fatigue is not included in the Cerebral score of the EDSS. The score ranges from 0 (normal) to 10 (death due to MS)|up to 36 months after the last patient was randomized|Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo.||Percentage of Participants||95% Confidence Interval|Number
772009|NCT00731692|Primary|Kaplan-Meier Estimate of the Risk of 3-month Confirmed Disability Progression Based on Composite Endpoint|3-month sustained increase from Baseline in EDSS (at least 1 point increase from Baseline for patients with a Baseline value of 5 or less or at least 0.5 point increase from Baseline for patients with a Baseline value of 5.5 or more) or 3-month sustained increase of at least 20% from BL in the time taken to complete the timed 25-foot walk test (25’ TWT); or 3-month sustained increase of at least 20% from BL in the time taken to complete the 9-HPT. The 25’ TWT is a quantitative measure of lower extremity function. The EDSS is a scale assessing neurologic impairment, including a series of scores in each of 8 functional systems: Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions. The score ranges from 0 (normal) to 10 (death due to MS)). The 9-hole peg test (9-HPT) is a quantitative measure of upper extremity (arm and hand) function.|up to 36 months after the last patient was randomized|Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo.||Percentage of Participants||95% Confidence Interval|Number
772058|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 8|Subject Satisfaction - length when inflated|6 months post-surgery|||% satisfactory or somewhat satisfactory|||Number
772059|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 8|Subject Satisfaction - length when inflated|3 months post-surgery|||% satisfactory or somewhat satisfactory|||Number
772015|NCT00731783|Secondary|Recurrence of CA-MRSA Skin or Soft Tissue Infection - 12 Month After Enrollment.|Recurrence of CA-MRSA Skin or Soft Tissue Infection|12 month after enrollment|Modified intention to treat analysis||Participants|||Number
772016|NCT00731783|Secondary|Recurrence of CA-MRSA Skin or Soft Tissue Infection - 6 Month After Enrollment.|Recurrence of CA-MRSA Skin or Soft Tissue Infection|6 month after enrollment|Modified intention to treat analysis||Participants|||Number
772017|NCT00731783|Secondary|Recurrence of CA-MRSA Skin or Soft Tissue Infection - 3 Month After Enrollment.|Recurrence of CA-MRSA Skin or Soft Tissue Infection|3 month after enrollment|Modified intention to treat analysis||Participants|||Number
772018|NCT00731783|Secondary|Recurrence of CA-MRSA Skin or Soft Tissue Infection - 1 Month After Enrollment.|Recurrence of CA-MRSA Skin or Soft Tissue Infection|1 month after enrollment|Modified intention to treat analysis||Participants|||Number
772019|NCT00731783|Secondary|Number of Index Patients Eradicated of S. Aureus Carriage - 12 Month After Performing Decolonization Measures|Eradication is defined as the absence of S. aureus carriage at the 3 sampled body sites (anterior nares, axilla, inguinal folds) of the index patient.|12 month after enrollment.|Modified intention to treat analysis||Participants|||Number
772020|NCT00731783|Secondary|Number of Index Patients Eradicated of S. Aureus Carriage - 6 Month After Performing Decolonization Measures|Eradication is defined as the absence of S. aureus carriage at the 3 sampled body sites (anterior nares, axilla, inguinal folds) of the index patient.|6 month after enrollment.|Modified intention to treat analysis||Participants|||Number
772021|NCT00731783|Secondary|Number of Index Patients Eradicated of S. Aureus Carriage - 3 Month After Performing Decolonization Measures|Eradication is defined as the absence of S. aureus carriage at the 3 sampled body sites (anterior nares, axilla, inguinal folds) of the index patient.|3 month after enrollment.|Modified intention to treat analysis||Participants|||Number
772022|NCT00731783|Primary|Number of Index Patients Eradicated of S. Aureus Carriage - 1 Month After Performing Decolonization Measures|Eradication is defined as the absence of S. aureus carriage at the 3 sampled body sites (anterior nares, axilla, inguinal folds) of the index patient.|1 month after enrollment.|Modified intention to treat analysis||Participants|||Number
772023|NCT00731822|Secondary|Mean Change From Baseline (Pre-dose on Day 1) in Weighted Mean FEV1 (0-4 Hours Post-dose) on Days 1 and 28|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Serial FEV1 measurements were taken electronically by spirometry at the Day 1 and Day 28 clinic visits (60 minutes pre-dose; immediately pre-dose; post-dose after 5, 15, and 30 minutes and 1, 2, and 4 hours. Weighted mean was calculated using the 24-hour serial FEV1 measurements that included the 0 to 4 hours post-dose assessment. At each time point, the highest of 3 technically acceptable measurements was recorded. Baseline FEV1 was defined as the mean of the two assessments obtained 30 minutes pre-dose and immediately pre-dose on Day 1. Change from Baseline was calculated as the average Day 28 FEV1 value minus the Baseline value. Analysis was performed using Mixed Model Repeated Measures (MMRM) with covariates of Baseline FEV1, sex, age, smoking status, treatment and day, and day by treatment and day by Baseline interactions.|Baseline (pre-dose on Day 1); Day 1 and Day 28|ITT Population. The number of participants presented (indicated by n=X, X in the category titles) represents the number of participants with data available at that time point. However all participants in the ITT Population without missing covariate information and with at least one post-Baseline measurement are included in the analysis.||Liters||Standard Error|Least Squares Mean
772024|NCT00731822|Secondary|Mean Change From Baseline in Clinic Visit Trough Forced Expiratory Volume in One Second (FEV1) on Days 2, 15, and 29|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Days 2, 15, and 29 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Days 1, 14, and 28. The highest of 3 technically acceptable measurements was recorded. Baseline FEV1 is defined as the mean of the two assessments obtained 30 minutes pre-dose and immediately pre-dose on Day 1. Change from Baseline was calculated as the Day 29 value minus the Baseline value. Analysis was performed using Mixed Model Repeated Measures (MMRM) with covariates of Baseline FEV1, sex, age, smoking status, treatment and day, and day by treatment and day by Baseline interactions.|Baseline; Day 2, Day 15, and Day 29|ITT Population. The number of participants presented (indicated by n=X, X in the category titles) represents the number of participants with data available at that time point. However all participants in the ITT Population without missing covariate information and with at least one post-Baseline measurement are included in the analysis.||Liters||Standard Error|Least Squares Mean
772025|NCT00731822|Primary|Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Study|Co-Primary Endpoint. An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; or is a congenital anomaly/birth defect. See the SAE/AE module of this results summary for a list of specific SAEs/AEs occurring in the study.|From Baseline (Day 1) until Follow-up (up to Study Day 37)|ITT Population||participants|||Number
772060|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 7|Subject Satisfaction - width when inflated|12 months post-surgery|||% satisfactory or somewhat satisfactory|||Number
772026|NCT00731822|Primary|Change From Baseline in Weighted Mean Heart Rate 0-4 Hours Post-dose at the End of the 28-day Treatment Period|Co-Primary Endpoint. Weighted mean was derived by calculating the average area under the curve (AUC), and then dividing by the relevant time interval. Baseline is the most recent result taken on or before pre-dose Day 1. Heart rate was recorded at 60 minutes (min) prior to dosing and at 15 min, 45 min, 90 min, 120 min, and 240 min post-dose on Day 28. Change from Baseline was calculated as the Day 28 value minus the Baseline value. Analysis was performed using a restricted maximum likelihood (REML)-based repeated measures mixed model approach (MMRM) with covariates of Baseline heart rate, sex, age, smoking status, treatment, and day and day by treatment and day by Baseline interactions. par.=participants.|Baseline to Day 28|Intent-to-Treat (ITT) Population: all randomized par. who received at least one dose of study medication. The number of par. presented represent those with data available at the time point being presented; however, all par. in the ITT Population without missing covariate information and with >=1 post-BL measurement are included in the analysis.||Beats per minute (bpm)||Standard Error|Least Squares Mean
772027|NCT00731874|Secondary|Development of New Onset Diabetes Mellitus||36 months||||||
772028|NCT00731874|Secondary|Incidence of Opportunistic Infection||36 months||||||
772029|NCT00731874|Secondary|Severity of Acute Rejection (by Banff Criteria and Need for Anti-lymphocyte Agents to Treat Acute Rejection)||12, 24, 36 months post-transplant||||||
772030|NCT00731874|Secondary|Time to Acute Rejection||12, 24, 36 months post-transplant|||months||Full Range|Median
772031|NCT00731874|Secondary|Perforin and Granzyme B mRNA Levels in Urine||Continuous||||||
772032|NCT00731874|Secondary|Renal Function (Estimated Glomerular Filtration Rate)||12, 18, 24, 36 months post-transplant||||||
772033|NCT00731874|Secondary|Incidence and Severity of Chronic Allograft Nephropathy||12, 24, 36 months post-transplant||||||
772034|NCT00731874|Secondary|Graft Survival||12, 18, 24, 36 months post-transplant||||||
772035|NCT00731874|Secondary|Patient Survival||12, 18, 24, 36 months post-transplant||||||
772036|NCT00731874|Primary|The Primary Endpoint Will be a Composite of the Following: Biopsy-confirmed Acute Rejection and Progression of Histologically Proven Chronic Allograft Nephropathy at 15 Months After Transplantation.||15 months post-transplant|||participants|||Number
772037|NCT00731939|Secondary|Assess Partner Satisfaction (Where Applicable)|The Partner Treatment Satisfaction Scale (TSS) was used. The TSS provides scores ranging from 0 to 100 in 5 domains of Ease of erection, Erectile function, Pleasure from sexual activity, Satisfaction with orgasm and Confidence to complete sexual activity with higher scores indicative of worse symptoms. Available data is summarized for each domain at each visit along with change from baseline.|6 months|||units on a scale||Standard Deviation|Mean
772038|NCT00731939|Secondary|Assess Partner Satisfaction (Where Applicable)|The Partner Treatment Satisfaction Scale (TSS) was used. The TSS provides scores ranging from 0 to 100 in 5 domains of Ease of erection, Erectile function, Pleasure from sexual activity, Satisfaction with orgasm and Confidence to complete sexual activity with higher scores indicative of worse symptoms. Available data is summarized for each domain at each visit along with change from baseline.|Baseline|||units on a scale||Standard Deviation|Mean
772039|NCT00731939|Secondary|Assess the Ease of Training for Titan® OTR - Question 9|How likely the subject will need continued training or retraining?|6 weeks|||percentage of participants|||Number
772040|NCT00731939|Secondary|Assess the Ease of Training for Titan® OTR - Question 8|How easy was it for the subject to learn?|6 weeks|||percentage of participants|||Number
772041|NCT00731939|Secondary|Assess the Ease of Training for Titan® OTR - Question 7|The subject likes the OTR pump?|6 weeks|||percentage of participants|||Number
772042|NCT00731939|Secondary|Assess the Ease of Training for Titan® OTR - Question 6|The OTR pump was easy to use at 1st cycling?|6 weeks|||percentage of participants|||Number
772043|NCT00731939|Secondary|Assess the Ease of Training for Titan® OTR - Question 5|Subject training with OTR pump was easier than with previous pump?|6 weeks|||percentage of participants|||Number
772044|NCT00731939|Secondary|Assess the Ease of Training for Titan® OTR - Question 4|It was easy for the subject to compress the deflation touch pads?|6 weeks|||percentage of participants|||Number
772045|NCT00731939|Secondary|Assess the Ease of Training for Titan® OTR - Question 3|It was easy for the subject to inflate the device?|6 weeks|||percentage of participants|||Number
772046|NCT00731939|Secondary|Assess the Ease of Training for Titan® OTR - Question 2|It was easy for the subject to find the deflation touch pads?|6 weeks|||percentage of participants|||Number
772047|NCT00731939|Secondary|Assess the Ease of Training for Titan® OTR - Question 1|It was easy for the subject to find the inflation bulb?|6 weeks|||percentage of participants|||Number
772048|NCT00731939|Secondary|Assess the Ease of Implant of the Titan® OTR - Question 3|The subject was easily able to accommodate the OTR pump?|At implant|||percentage of responses|||Number
772049|NCT00731939|Secondary|Assess the Ease of Implant of the Titan® OTR - Question 2|Titan OTR pre-implant product preparation was easier than your usual pump of choice?|At implant|||percentage of responses|||Number
772050|NCT00731939|Secondary|Assess the Ease of Implant of the Titan® OTR Question 1|Titan OTR pre-implant product preparation was straightforward/simple?|At implant|||percentage of responses|||Number
772051|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 10|Subject Satisfaction - if you had the decision to make again, would you undergo this penile implant procedure again?|12 months post-surgery|||"% responding yes and probably"|||Number
772052|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 10|Subject Satisfaction - if you had the decision to make again, would you undergo this penile implant procedure again?|6 months post-surgery|||"% responding yes and probably"|||Number
772053|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 10|Subject Satisfaction - if you had the decision to make again, would you undergo this penile implant procedure again?|3 months post-surgery|||"% responding yes and probably"|||Number
772054|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 9|Subject Satisfaction - would you recommend this penile implant device to men with the same erectile difficulty that you had?|12 months post-surgery|||"% responding yes and probably"|||Number
772055|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 9|Subject Satisfaction - would you recommend this penile implant device to men with the same erectile difficulty that you had?|6 months post-surgery|||"% responding yes and probably"|||Number
772081|NCT00731939|Primary|Assess the Ease of Deflation of the Titan® OTR Pump|"The study's primary endpoint was to demonstrate that at least 64% of subjects were mostly or completely satisfied with the ability to deflate the device at the 6-month follow-up. The study's primary objective was to assess the ease of deflation of the Titan® OTR pump via subject questionnaire at 6-month follow-up. Subjects were asked via questionnaire how satisfied they were with ease of deflation of their implant. Success criteria was a response of satisfactory or somewhat satisfactory. Other possible responses were neither satisfactory nor unsatisfactory, somewhat unsatisfactory, and very unsatisfactory."|6 months|||% of participants meeting success criter|||Number
772082|NCT00732030|Secondary|Patient Satisfaction Survey|Satisfaction for daytime distance vision, nighttime distance vision, and indoors distance vision on a scale of 1 to 5, with 1 being very dissatisfied and 5 being very satisfied.|6 months|||Units on a Scale||Standard Deviation|Mean
772083|NCT00732030|Primary|Residual Refractive Cylinder|Residual Refractive Cylinder at month 6 measured in diopters (D).|6 Month|||Diopters||Standard Deviation|Mean
772084|NCT00732030|Primary|Best Corrected Distance Visual Acuity|Best Corrected Distance Visual Acuity at month 6 measured in LogMAR. LogMAR is the “logarithm of the minimum angle of resolution”. It is a unit of measure for visual acuity (VA).|6 Months|Data was collected for 29 eyes in 24 patients.||logMAR||Standard Deviation|Mean
772085|NCT00732030|Primary|Uncorrected Distance Visual Acuity|Uncorrected Distance Visual Acuity at month 6 measured in logMAR. LogMAR is the “logarithm of the minimum angle of resolution”. It is a unit of measure for visual acuity (VA).|6 months|Data was collected for 29 eyes in 24 patients.||logMAR||Standard Deviation|Mean
772086|NCT00732069|Secondary|F2-Isoprostanes|Mean difference in F2-isoprostanes during dialysis between treatment with ramipril or valsartan and placebo|During dialysis after one week of study drug|||pg/mL||Standard Error|Mean
772087|NCT00732069|Primary|Interleukin 1 Beta|Mean difference in interleukin 1 beta concentration during treatment with ramipril versus treatment with placebo|During dialysis after one week of study drug|All participants who completed the three arm treatment.||pg/mL||Standard Error|Mean
772088|NCT00732160|Secondary|Insulin Sensitivity|Insulin sensitivity index (ISI) was calculated by dividing the average glucose infusion rate (mg glucose infusion/kg body weight/min) by the average insulin concentration (uU/mL) from 90 to 120 minutes. This was multiplied by 100 (thus, x100 in units description), per reporting convention in literature.|3 hours|Three subjects were excluded or withdrew after infusion but before hyperglycemic clamp due to low potassium, loss of IV access, burning at IV site. These 3 participants were not included in final analysis.||mg/kg/min per uU/mL*100||Standard Deviation|Mean
772089|NCT00732160|Primary|Insulin Secretion|Acute Insulin response during Hyperglycemic clamp (delta insulin uU/mL, t=0-10)|3 hours|Three subjects were excluded or withdrew after infusion but before hyperglycemic clamp due to low potassium, loss of IV access, burning at IV site. These 3 participants were not included in final analysis.||uU/mL||Standard Deviation|Mean
772090|NCT00732199|Secondary|Brief Hyperoxia Response|Brief hyperoxia response was the nadir minute ventilation achieved immediately upon exposure to brief hyperoxia expressed as a percent of eupneic minuted ventilation.|4-6 wks for each participant|young adults: 3 women/6 men; older adults: 6 women/4 men; participants with data available were included in the analysis||percentage of eupneic minute ventilaion||Standard Error|Mean
772091|NCT00732199|Secondary|Hypoxic Ventilatory Response|Hypoxic ventilatory response was calculated as the change in minuted ventilation for a change in oxygen saturation during each hypoxia trial.|4-6 wks for each participant|older adults: 7 women/6 men; young adults: 6 women/4 men;participants with data available were included in the analysis||Liter/minute/%saturation||Standard Error|Mean
772092|NCT00732199|Primary|Long-term Facilitation (LTF) of Ventilation, Minute Ventilation Was Measured in Older Adults Only|Episodic hypoxia (EH) leads to sustained elevation of the ventilatory motor output, referred to as LTF, an excitatory mechanism characterized by a sustained elevation in ventilatory motor output following EH. Minute ventilation during recovery period after multiple trials of EH. This is reported in older adults on this grant.|4-6 wks for each participant|Older adults 8 women/6 men;participants with data available were included in the analysis||percentage of control minute ventilation||Standard Error|Mean
772093|NCT00732199|Primary|Apneic Threshold (AT) and Carbon-dioxide (CO2) Reserve|The AT was defined as the end-tidal (PETCO2) that demarcated the central apnea closest to the eupneic PETCO2. The CO2 reserve was defined as the difference in PETCO2 between eupnea and AT.|4-6 wks for each participant|Older adults : n=10, 6 females/4 males Young n=15, 8 females/ 7 males; participants with data available were included in the analysis||mm Hg||Standard Error|Mean
772094|NCT00732212|Other Pre-specified|Hospital Days After Randomization|Comparisons of days spent in the ICU and hospital will be quantitated & compared in 2 subgroups- non-variceal or variceal-portal hypertension lesions according to standard visually guided hemostasis vs. Doppler assisted.|30 days|||Days||Standard Deviation|Mean
772095|NCT00732212|Secondary|Units of Red Blood Cells (RBC) Transfused for Rebleeding After Randomization|RBC units of transfusion post-randomization will be quantitated & compared in 2 subgroups- non-variceal or variceal-portal hypertension lesions according to standard visually guided hemostasis vs. Doppler assisted.|30 days|||Units of RBC||Standard Deviation|Mean
772096|NCT00732212|Secondary|Death|Death up to 30 days from a co-morbid condition, bleeding, or another cause in 2 subgroups- non-variceal or variceal-portal hypertension lesions according to standard visually guided hemostasis vs. Doppler assisted.|30 days|||Participants|||Count of Participants
772097|NCT00732212|Secondary|Rate of Complications|Rates for each treatment group will be determined and compared for General medical complications (pneumonia, infection, myocardial infarction, stroke) & GI procedure related (perforation, aspiration) up to 30 days in 2 subgroups- non-variceal or variceal-portal hypertension lesions according to standard visually guided hemostasis vs. Doppler assisted.|30 days|||Participants|||Count of Participants
772098|NCT00732212|Secondary|Rates of Surgery up to 30 Days After Randomization|GI surgery rate for control of active bleeding or rebleeding - up to 30 days after randomization in 2 subgroups- non-variceal or variceal-portal hypertension lesions according to standard visually guided hemostasis vs. Doppler assisted.|30 days|||Participants|||Count of Participants
772099|NCT00732212|Primary|30 Day Rebleeding Rate|The primary outcome is index lesion rebleeding rate up to 30 days in 2 subgroups- non-variceal or variceal-portal hypertension lesions according to standard visually guided hemostasis vs. Doppler assisted.|30 days|||Participants|||Count of Participants
772100|NCT00732225|Secondary|Physician Survey - Anterior Chamber Dome Maintenance During IOL Insertion|Surgeon reporting of Anterior Chamber Dome Maintenance During Intraocular Lens (IOL) insertion into a patient's eye. Evaluated on a subjective scale and reported as percent by response. The scale, from worst to best, is as follows: Flat, Shallow, Working Space Adequate, Full Chamber Maintenance|Time of Surgery|This data was collected on all eyes of patients undergoing surgery with the exception of the following: 17 DisCoVisc eyes, 20 DuoVisc eyes, 6 BioVisc eyes,4 Healon5 eyes, and 14 Amvisc Plus eyes.||Percentage of Eyes|||Number
772101|NCT00732225|Secondary|Physician Survey - Anterior Chamber Dome Maintenance During Phacoemulsification|Surgeon reporting of Anterior Chamber Dome Maintenance of a patient's eye during Phacoemulsification. Evaluated on a subjective scale and reported as percent by response. The following scale is used, from worst to best: Flat, Shallow, Working Space Adequate, Full Chamber Maintenance|Time of Surgery|This data was collected on all eyes of patients undergoing surgery with the exception of the following: 17 DisCoVisc eyes, 19 DuoVisc eyes, 6 BioVisc eyes,3 Healon5 eyes, and 11 Amvisc Plus eyes.||Percentage of Eyes|||Number
772102|NCT00732225|Secondary|Physician Survey - Anterior Chamber Dome Maintenance During Anterior Capsulotomy|Surgeon reporting of Anterior Chamber Dome Maintenance of a patient's eye During Anterior Capsulotomy. Evaluated on a subjective scale and reported as percent by response. The following scale is used, from worst to best: Flat, Shallow, Working Space Adequate, Full Chamber Maintenance.|Time of Surgery|This data was collected on all eyes of patients undergoing surgery with the exception of the following: 2 DisCoVisc eyes and 2 Healon5 eyes||Percentage of Eyes|||Number
772103|NCT00732225|Secondary|Intraocular Pressure (IOP)|Measure of intraocular pressure of a patient's eye via tonometry one day after surgery. Measured in mmHg. Normal intraocular pressure between 10 mmHg and 20 mmHg.|1 day following surgery|This data was collected on all eyes of patients attending the 1 day postoperative visit with the exception of the following: 3 DisCoVisc patients, 4 DuoVisc patients, 1 Healon5 patient, and 4 Amvisc Plus patients.||mmHg||Standard Deviation|Mean
772104|NCT00732225|Secondary|Aqueous Signs - Aqueous Cells|"Measured as the percentage of patient's eyes subjectively evaluated to have Aqueous Cells at each of the following gradings:
0 - None
- 1 to 5 cells
- 6 to 15 cells
- 16 to 30 cells
- >30 cells"|1 day following surgery|This data was collected on all eyes of patients attending the 1 day post-operative visit.||Percentage of Eyes|||Number
772105|NCT00732225|Secondary|Aqueous Signs – Aqueous Flare|"Measured as the percentage of patient's eyes subjectively evaluated to have Aqueous Flare at each of the following gradings:
0-None: No visible flare when compared with the normal eye.
Mild: Flare visible against dark papillary background but not visible against iris background.
Moderate: Flare is visible with the slit-lamp beam aimed onto the iris surface as well as the dark papillary background.
Severe: Very dense flare. May also present as a hazy appearance of anterior segment structures when viewed with low power magnification of the slit-lamp."|1 day following surgery|This data was collected on all eyes of patients attending the 1 day postoperative visit.||Percentage of Eyes|||Number
772106|NCT00732225|Secondary|Aqueous Signs - Corneal Edema|"Measured as the percentage of patient's eyes subjectively evaluated to have corneal edema at each of the following gradings:
0 - None
- Mild, slight localized or generalized edema
- Moderate, significant localized or generalized edema
- Severe, advanced localized or generalized edema"|1 day after surgery|This data was collected on all eyes of patients attending the 1-day visit.||Percentage of Eyes|||Number
772107|NCT00732225|Primary|Percent Loss of Endothelial Cells|Percentage of corneal endothelial cells lost 2 months after surgery as compared to the number of corneal endothelial cells measured before the operation. Corneal Endothelial Cells are measured by counting the number of cells on an image taken by specular microscope.|2 months following surgery|This data was collected on the eyes of patients attending the visit 2 months after surgery.||Percent Loss||Standard Deviation|Mean
772108|NCT00732238|Secondary|The Secondary Efficacy Outcome is Recurrence of UTI up to 180 Days After the End of Therapy|Relapse of UTI is defined as a recurrence of clinical manifestations of infection plus growth of the original infecting pathogen(s) in urine culture in association with significant pyuria (>10 WBC/phf)|Up to 180 days of end of therapy|||participants|||Number
772109|NCT00732238|Primary|The Primary Efficacy Outcome of the Study is Response to Treatment Which Will be Assessed at the End of Therapy. Successful Response to Treatment is Defined as Resolution of Clinical Manifestations of Infection Plus Lack of Growth of the Original Infect||Patients will be evaluated for signs of continued infection at mid therapy and at the end of antibiotic therapy (day 5 for new catheter arm and day 10 for existing catheter arm)|||participants|||Number
772110|NCT00732303|Secondary|Overall Survival|To determine overall survival of pemetrexed and concurrent definitive radiation in patients with poor risk stage III NSCLC.|24 months|No data was collected and analyzed for this outcome measure due to termination of the study.|||||
772111|NCT00732303|Secondary|Assess Safety and Toxicity|- To determine the toxicities of pemetrexed and concurrent definitive radiation in patients with poor risk stage III NSCLC.|24 months|Most frequent toxicities reported.||participants|||Number
772112|NCT00732303|Primary|Progression Free Survival|To determine progression free survival in patients with poor risk stage III NSCLC treated with pemetrexed and concurrent definitive radiation|24 months|No data was collected and analyzed for this outcome measure due to termination of the study|||||
772113|NCT00732381|Secondary|The Change From Baseline in Average AM/PM PRIOR Total Nasal Symptom Score Over 15 Days|Total nasal symptom score (TNSS) is a composite of 4 symptoms, each is scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total can range from 0 to 12. PRIOR (the subject's status over the previous 12 hours [reflective])|15 days of treatment|||Units on a scale||Standard Deviation|Least Squares Mean
772114|NCT00732381|Primary|The Change From Baseline in Average AM/PM PRIOR Nasal Congestion Score Over 15 Days|Nasal congestion was scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe symptoms. PRIOR (the subject's status over the previous 12 hours [reflective])|15 days of treatment|The standard deviation is pooled.||Units on a scale||Standard Deviation|Least Squares Mean
772115|NCT00732472|Secondary|Urine Half Life (t1/2) of UMEC on Day 7|Urine half life (t1/2) of UMEC on Day 7 was estimated. Urine samples were collected from 0-4 hours (hr), 4-8 hr, 8-12 hr, and 12-24 hr on Day 7.|From 0-4 hours (hr), 4-8 hr, 8-12 hr, and 12-24 hr on Day 7|PK Population. Only participants with data available at the indicated time points were summarized.||hours||Geometric Coefficient of Variation|Geometric Mean
772116|NCT00732472|Secondary|Renal Clearance of UMEC on Day 1 and Day 7|Renal clearance was calculated as the urinary recovery of unchanged drug from time zero to time x (Ae[0-x])/area under concentration from time zero to time x (AUC[0-x]) for the longest period of time after dosing when both could be accurately determined (where x is either 8, 12, or 24). Urine samples were collected from 0-8 hours (hr), 8-12 hr, and 12-24 hr on Day 1 and from 0-4 hr, 4-8 hr, 8-12 hr, and 12-24 hr on Day 7.|From 0-8 hours (hr), 8-12 hr, and 12-24 hr on Day 1; from 0-4 hr, 4-8 hr, 8-12 hr, and 12-24 hr on Day 7|PK Population. Only participants with data available at the indicated time points were summarized. Different participants may have been summarized for different parameters/at different time points (reflected by n=X, X, X, X in the category titles), so the overall number of participants summarized reflects everyone in the PK Population.||Liters/hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
772117|NCT00732472|Secondary|Fe(0-4), Fe(0-8), Fe(0-12), and Fe(0-24) of UMEC on Day 1 and Day 7|The fraction of the total dose excreted (Fe) in each interval was estimated as the urinary recovery of unchanged drug (Ae) per dose. Urine samples were collected from 0-8 hours (hr), 8-12 hr, and 12-24 hr on Day 1 and from 0-4 hr, 4-8 hr, 8-12 hr, and 12-24 hr on Day 7.|From 0-8 hours (hr), 8-12 hr, and 12-24 hr on Day 1; from 0-4 hr, 4-8 hr, 8-12 hr, and 12-24 hr on Day 7|PK Population: Only participants with data available at the indicated time points were summarized. Different participants may have been summarized for different parameters/at different time points (reflected by n=X, X, X, X in the category titles), so the overall number of participants summarized reflects everyone in the PK Population.||Percentage of dose administered||Standard Deviation|Mean
772118|NCT00732472|Secondary|Ae(0-4), Ae(0-8), Ae(0-12), and Ae(0-24) of UMEC on Day 1 and Day 7|Urinary recovery of unchanged drug (UMEC) within the first 8, 12, and 24 hours (Ae[0-8], Ae[0-12], and Ae[0-24], respectively) on Day 1 and within the first 4, 8, 12, and 24 hours (Ae[0-4], Ae[0-8], Ae[0-12], and Ae[0-24], respectively) on Day 7 was estimated. Urine samples were collected from 0-8 hours (hr), 8-12 hr, and 12-24 hr on Day 1 and from 0-4 hr, 4-8 hr, 8-12 hr, and 12-24 hr on Day 7.|From 0-8 hours (hr), 8-12 hr, and 12-24 hr on Day 1; from 0-4 hr, 4-8 hr, 8-12 hr, and 12-24 hr on Day 7|PK Population. Only participants with data available at the indicated time points were summarized. Different participants may have been summarized for different parameters/at different time points (reflected by n=X, X, X, X in the category titles), so the overall number of participants summarized reflects everyone in the PK Population.||nanograms (ng)||Geometric Coefficient of Variation|Geometric Mean
772119|NCT00732472|Secondary|Tmax and Tlastof UMEC on Day 1 and Day 7|Tmax is defined as the time to reach the observed maximum concentration, and tlast is defined as the time of the last quantifiable concentration of UMEC; both were measured on Day 1 and Day 7. Blood samples were collected pre-dose, and 5 min, 15 min, 30 min, 1 hr, 2 hr, 4 hr, and 8 hr post-dose on Day 1 and Day 7. Also, a 24 hr blood sample was collected on Day 7.|Day 1 and Day 7: pre-dose, and 5 min, 15 min, 30 min, 1 hr, 2 hr, 4 hr, and 8 hr post-dose; 24 hr post-dose on Day 7|PK Population. Only participants with data available at the indicated time points were summarized. Different participants may have been summarized for different parameters/at different time points (reflected by n=X, X, X, X in the category titles), so the overall number of participants summarized reflects everyone in the PK Population.||hours||Full Range|Median
772120|NCT00732472|Secondary|Cmax of UMEC on Day 1 and Day 7|Cmax is defined as the maximum observed concentration of UMEC and was measured on Day 1 and Day 7. Blood samples were collected pre-dose and 5 min, 15 min, 30 min, 1 hr, 2 hr, 4 hr, and 8 hr post-dose on Day 1 and Day 7. Also, a 24 hr blood sample was collected on Day 7.|Day 1 and Day 7: pre-dose, and 5 min, 15 min, 30 min, 1 hr, 2 hr, 4 hr, and 8 hr post-dose; 24 hr post-dose on Day 7|PK Population. Only participants with data available at the indicated time points were summarized.||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
772121|NCT00732472|Secondary|Mean AUC(0-2), AUC(0-8), and AUC(0-t) of UMEC on Day 1 and Day 7|Area under the concentration-time (AUC) curve from time zero (pre-dose) to 2 hours (AUC[0-2]), from time zero to 8 hours (AUC[0-8]), from time zero to the last time of a quantifiable concentration of UMEC (AUC[0-t]) on Day 1 and Day 7 were measured. AUC is a measure of systemic exposure. Blood samples were collected pre-dose and 5 min, 15 min, 30 min, 1 hr, 2 hr, 4 hr, and 8 hr post-dose on Day 1 and Day 7. Also, a 24 hr blood sample was collected on Day 7.|Day 1 and Day 7: pre-dose, and 5 min, 15 min, 30 min, 1 hr, 2 hr, 4 hr, and 8 hr post-dose; 24 hr post-dose on Day 7|Pharmacokinetic (PK) Population: participants (par.) in the ASP for whom a PK sample was obtained and analyzed. Different par. may have been summarized for different parameters/at different time points (reflected by n=X, X, X, X in the category titles), so the overall number of par. summarized reflects everyone in the PK Population.||hr * nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
772122|NCT00732472|Primary|Mean Corpuscle Volume (MCV) Values on Day 1 and Day 7|Blood samples were collected for the measurement of MCV pre-dose on Day 1 and Day 7.|Day 1 and Day 7|All Subjects Population. Only participants with data available at the indicated time points were summarized. Different participants may have been summarized for different parameters/at different time points (reflected by n=X, X, X, X in the category titles), so the overall number of participants summarized reflects everyone in the ASP.||10^-15 liters (femtoliters)||Standard Deviation|Mean
772123|NCT00732472|Primary|Mean Corpuscle Hemoglobin (MCH) Values on Day 1 and Day 7|Blood samples were collected for the measurement of MCH pre-dose on Day 1 and Day 7.|Day 1 and Day 7|All Subjects Population. Only participants with data available at the indicated time points were summarized. Different participants may have been summarized for different parameters/at different time points (reflected by n=X, X, X, X in the category titles), so the overall number of participants summarized reflects everyone in the ASP.||picograms/cell (pg)||Standard Deviation|Mean
772124|NCT00732472|Primary|Basophil, Eosinophil, Lymphocyte, Monocyte, Total Neutrophil (ANC: Absolute Neutrophil Count), Platelet, and White Blood Cell (WBC) Count Values on Day 1 and Day 7|Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, total neutrophils (ANC), platelets, and white blood cell (WBC) count pre-dose on Day 1 and Day 7.|Day 1 and Day 7|All Subjects Population. Only participants with data available at the indicated time points were summarized. Different participants may have been summarized for different parameters/at different time points (reflected by n=X, X, X, X in the category titles), so the overall number of participants summarized reflects everyone in the ASP.||10^9 cells per liter (GI/L)||Standard Deviation|Mean
772806|NCT00734162|Secondary|Change From Baseline in Z-score for Spine BMD at Week 192|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 192|Participants in the Safety Analysis Set with available data were analyzed.||z-score||Standard Deviation|Mean
772125|NCT00732472|Primary|Calcium, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values on Day 1 and Day 7|Blood samples were collected for the measurement of calcium, glucose, potassium, sodium, and urea/BUN pre-dose on Day 1 and Day 7.|Day 1 and Day 7|All Subjects Population. Only participants with data available at the indicated time points were summarized. Different participants may have been summarized for different parameters/at different time points (reflected by n=X, X, X, X in the category titles), so the overall number of participants summarized reflects everyone in the ASP.||Millimoles per liter (mmol/L)||Standard Deviation|Mean
772126|NCT00732472|Primary|Direct Bilirubin, Total Bilirubin, and Creatinine Values on Day 1 and Day 7|Blood samples were collected for the measurement of direct bilirubin, total bilirubin, and creatinine at pre-dose on Day 1 and Day 7.|Day 1 and Day 7|All Subjects Population. Only participants with data available at the indicated time points were summarized. Different participants may have been summarized for different parameters/at different time points (reflected by n=X, X, X, X in the category titles), so the overall number of participants summarized reflects everyone in the ASP.||Micromoles per liter (µmol/L)||Standard Deviation|Mean
772127|NCT00732472|Primary|Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Values on Day1 and Day 7|Blood samples were collected for the measurement of ALP, ALT, AST, and GGT Pre-dose on Day 1 and Day 7.|Day 1 and Day 7|All Subjects Population. Only participants with data available at the indicated time points were summarized. Different participants may have been summarized for different parameters/at different time points (reflected by n=X, X, X, X in the category titles), so the overall number of participants summarized reflects everyone in the ASP.||International units per liter (IU/L)||Standard Deviation|Mean
772128|NCT00732472|Primary|Albumin, Total Protein, Hemoglobin, and Mean Corpuscle Hemoglobin Concentration (MCHC) Values on Day 1 and Day 7|Blood samples were collected for the measurement of albumin, total protein, hemoglobin, and MCHC values pre-dose on Day 1 and Day 7.|Day 1 and Day 7|All Subjects Population. Only participants with data available at the indicated time points were summarized. Different participants may have been summarized for different parameters/at different time points (reflected by n=X, X, X, X in the category titles), so the overall number of participants summarized reflects everyone in the ASP.||Grams per liter (G/L)||Standard Deviation|Mean
772129|NCT00732472|Primary|Total Number of Salbutamol Doses Taken Over the 7 -Day Study Period|The total number of salbutamol doses taken per day was recorded by the participants in their dairy card over the entire 7-day treatment period. Diaries were reviewed by the Investigator when participants were admitted to the unit on Day 1, Day 7, and Day 8. Salbutamol was given as rescue medication, defined as a quick-relief or fast-acting medication that is given in addition to the investigational drug or placebo that can alleviate symptoms due to disease or lack of efficacy of the study treatment.|Day 1 to Day 7|All Subjects Population. Only those participants who took at least one dose of salbutamol were summarized.||salbutamol doses|||Number
772130|NCT00732472|Primary|Mean Forced Expiratory Volume in One Second (FEV1) at Screening and on Days 1 and 7|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured at Screening, pre-dose, and 4 hours (hr) post-dose on Day 1 and Day 7. FEV1 tests were repeated until three technically acceptable measurements were made.|Screening, Day 1, and Day 7|All Subjects Population. Only participants with data available at the indicated time points were summarized.||Liters||Standard Deviation|Mean
772131|NCT00732472|Primary|Maximum and Mean (0-24 Hour) Heart Rate From Holter Monitoring on Day 7|Maximum heart rate (Max HR) and mean HR from 0-24 hour Holter monitoring on treatment Day 7 were derived. The analysis was adjusted for treatment and Baseline, where Baseline is defined as the corresponding summary measure (i.e., mean heart rate [0-24 hours] or maximum heart rate [0-24 hours]) from screening records.|Day 7|All Subjects Population. The number of participants presented represent those with data available at the time point being presented; however, all participants in the ASP without missing covariate information are included in the analysis.||Beats per minute||Standard Error|Least Squares Mean
772132|NCT00732472|Primary|Number of Participants With Abnormal 24-hour Holter Findings at Screening and Day 7|Twenty-four hour Holter ECG values were obtained at Screening and on Day 7. During the Screening procedure and study, standard Holter monitors were used (in order to exclude participants with underlying cardiac arrhythmogenicity). During the treatment periods, Holter monitors were only switched on immediately prior to dosing (up to 15 minutes pre-dose) so as to capture Holter ECG data from the 24 hour period following dosing. The following summary data were transcribed into the Case Report Form: Maximum and mean (0 to24 hour) heart rate; normal and aberrant beats and arrhythmias. Analysis of the Holter tapes was arranged by GlaxoSmithKline.The number of participants with normal (NL), abnormal not clinically significant (Abn NCS), and abnormal clinically significant (Abn CS) ECG findings, as well as those with unavailable results (NA) at Screening and Day 7, are reported. Clinical significance was based on the medical and scientific judgement of the investigator or qualified designee.|Screening and Day 7|All Subjects Population. Only participants with data available at the indicated time points were summarized.||Participants|||Number
772133|NCT00732472|Primary|Number of Participants With the Indicated 12-lead Electrocardiogram (ECG) Values on Days 1 and 7|The number of participants with normal (NL), abnormal not clinically significant (Abn NCS), and abnormal clinically significant (Abn CS) ECG findings, as well as those with unavailable results (NA) at pre-dose (PD1, PD2, PD3), and 15 min, 45 min, 1.5 hr, 4 hr, and 8 hr post-dose (PD) on Day 1 and at pre-dose (PD1, PD2, PD3), and 15 min, 45 min, 1.5 hr, 4 hr, 8 hr, and 24 hr post-dose on Day 7 are reported. The following are of potential clinical importance: absolute QTc interval >450 milliseconds (msec); increase from Baseline QTc >60 msec; PR interval <110 and >220 msec; QRS interval <75 and >110 msec. Clinical significance was based on the medical and scientific judgement of the investigator or qualified designee.|Day 1 (pre-dose and 15 min, 45 min, 1.5 hr, 4 hr, and 8 hr post-dose) and Day 7 (pre-dose and 15 min, 45 min, 1.5 hr, 4 hr, 8 hr, and 24 hr)|All Subjects Population. Only participants with data available at the indicated time points were summarized.||Participants|||Number
772213|NCT00733135|Secondary|Preservation of Run-off Distal to the Filter|Preservation of run-off distal to SpiderFX™ distal embolic protection device was determined by angiography of run-off vessels at the end of the procedure, as adjudicated by the angiographic core laboratory.|at the end of the procedure|115/133 subjects had the required angiographic images to assess this outcome.||percentage of participants|||Number
786179|NCT00833690|Secondary|Serum Urate|From blood sample drawn after taking study drug that day|End of Study Drug Visit (ESD) (Month 9-24; 263-727 days after Baseline Visit)|||mg/dL||Standard Deviation|Mean
772134|NCT00732472|Primary|Maximum and Weighted Mean (0-4 Hour) Heart Rate at Days 1 and 7|Maximum heart rate (Max HR) and weighted mean (WM) from 0-4 hour on Days 1 and 7 were derived. Max HR (0-4 h) is defined as the maximum heart rate attained within 0-4 h. The weighted mean HR (0-4 h) was derived by calculating the area under the curve, and then dividing the value by the relevant time interval. Each of the maximum and weighted mean (0-4h) endpoints for heart rate, was statistically analyzed using a mixed effects model. The terms treatment, baseline, day and any relevant interactions were considered in the model. Least squares means are adjusted for treatment, Baseline, day, treatment by Baseline and Baseline by day interaction, where Baseline is defined as the mean of the three pre-dose assessments.|Day 1 and Day 7|All Subjects Population (ASP). The number of participants presented represent those with data available at the time point being presented; however, all participants in the ASP without missing covariate information are included in the analysis.||Beats per minute||Standard Error|Least Squares Mean
772135|NCT00732472|Primary|Mean Heart Rate (HR) on Days 1 and 7|HR was measured in a semi-recumbent position at approximately 45 degrees after the participant was kept at rest for at least 5 minutes. HR was obtained at pre-dose and 15 min, 45 min, 1.5 hr, 4 hr, and 8 hr post-dose (PD) on Day 1 and at pre-dose and 15 min, 45 min, 1.5 hr, 4 hr, 8 hr, and 24 hr PD on Day 7.|Day 1 (pre-dose and 15 minutes [min], 45 min, 1.5 hours [hr], 4 hr, and 8 hr post-dose) and Day 7 (pre-dose and 15 min, 45 min, 1.5 hr, 4 hr, 8 hr, and 24 hr post-dose)|All Subjects Population. Only participants with data available at the indicated time points were summarized. Different participants may have been summarized for different parameters/at different time points (reflected by n=X, X, X, X in the category titles), so the overall number of participants summarized reflects everyone in the ASP.||Beats per minute||Standard Deviation|Mean
772136|NCT00732472|Primary|Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) on Days 1 and 7|Blood pressure was measured in a semi-recumbent position at approximately 45 degrees after the participant was kept at rest for at least 5 minutes. SBP and DBP were obtained at pre-dose and 15 min, 45 min, 1.5 hr, 4 hr, and 8 hr post-dose (PD) on Day 1 and at pre-dose and 15 min, 45 min, 1.5 hr, 4 hr, 8 hr, and 24 hr PD on Day 7.|Day 1 (pre-dose and 15 minutes [min], 45 min, 1.5 hours [hr], 4 hr, and 8 hr post-dose) and Day 7 (pre-dose and 15 min, 45 min, 1.5 hr, 4 hr, 8 hr, and 24 hr post-dose)|All Subjects Population (ASP). Only participants with data available at the indicated time points were summarized. Different participants may have been summarized for different parameters/at different time points (reflected by n=X, X, X, X in the category titles), so the overall number of participants summarized reflects everyone in the ASP.||Millimeters of mercury (mmHg)||Standard Deviation|Mean
772137|NCT00732472|Primary|Number of Participants With Any On-treatment Adverse Event (AE) or Any On-treatment Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An on-treatment adverse event is defined as an event that occurred between the start of investigational product and follow-up contact. Refer to the general SAE/non-serious AE module for a complete list of AEs reported in the study. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect.|From start of treatment to study day 12|All Subjects Population: all participants who received at least one dose of study medication||participants|||Number
772138|NCT00732615|Secondary|Percentage of Subjects With Any Clinical Symptoms of Hypocalcemia During Weeks 16-24.|Clinical symptoms were a selected group of adverse events that occurred during study weeks 16 through 24. The group of terms were defined by key opinion leaders and documented in study protocol.|8 Weeks|Intent to Treat (ITT) population.||percentage of participants|||Number
772139|NCT00732615|Secondary|Proportion of Subjects Who Achieved Independence From Active Vitamin D and an Oral Calcium Dose of ≤ 500 mg/Day at Week 24.|Subjects Who Achieved Independence from Active Vitamin D Usage and with Calcium Dose of 500 mg/day or less. This analysis was based on Investigator Prescribed Data.|24 Weeks|Intent to Treat (ITT) population subjects with Baseline and Week 24 data.||percentage of participants|||Number
772140|NCT00732615|Secondary|Percentage Changes From Baseline in Daily Calcium Dose at Week 24.|The analysis of this endpoint was based on investigator prescribed data.|24 Weeks|Intent to Treat (ITT) population subjects with Baseline and Week 24 data||percentage change from baseline||Standard Deviation|Mean
772141|NCT00732615|Primary|The Percentage of Subjects Who Met the Triple Efficacy Endpoint Criteria at Week 24.|The triple efficacy endpoint criteria were defined as at least a 50% reduction from the baseline in oral calcium dose and at least a 50% reduction from the baseline in active vitamin D dose and an albumin-corrected total serum calcium concentration that was maintained or normalized compared to the baseline value (≥ 7.5 mg/dL) and did not exceed the upper limit of the laboratory normal range. The analysis of primary efficacy endpoint was based on investigator prescribed data.|Week 24 of dosing|Intent to Treat (ITT) population, which includes all randomized subjects who received at least 1 dose of study drug and had at least 1 post-baseline efficacy assessment.||percentage of participants||95% Confidence Interval|Number
772142|NCT00732641|Secondary|Quality of Life|Participants were given the Europen Organization for Research in Cancer Therapy Quality of Life Questionnaire (EORTC QLQ), version 2.0, which consisted of 30 questions. The questionnaire evaluated global health/quality of life and incorporated five functional scales (Physical; Role; Emotional; Cognitive; Social). All of the scales ranged in score from 0 (worst) to 100 (best).|Screening and Last Observation (up to 5 years)|"Intent-to-treat population (those who received at least one dose of study drug).
The number of participants analyzed varied depending on the number of observations available for each category."||Score on a scale||Standard Deviation|Mean
772143|NCT00732641|Secondary|Number of Participants With Progressive Disease(PD) or Relapse From CR|"PD (for patients not in CR) required one or more of the following:
25% increase in serum monoclonal paraprotein level, 24-hour urinary light chain excretion, or plasma cells;
Increase in size of existing or development of new bone lesions/soft tissue plasmacytomas;
Development of hypercalcemia.
Relapse from CR required at least one of the following:
Reappearance of serum or urinary paraprotein;
>5% plasma cells;
Development of new lytic bone lesions or soft tissue plasmacytomas or increase in the size of residual bone lesions;
Development of hypercalcemia."|Month 9 & Month 18|Intent-to-treat population (those who received at least one dose of study drug)||Participants|||Number
772214|NCT00733135|Secondary|Presence of Debris in Deployed SpiderFx™ Embolic Protection Device|Presence of debris in deployed SpiderFx™ embolic protection device|at the end of the procedure|||percentage of deployed filters|Participants||Number
772144|NCT00732641|Secondary|Number of Participants With Minimal Response (MR) to Treatment|"MR was defined as:
A 25-49% reduction in the level of the serum monoclonal paraprotein maintained for a minimum of 6 weeks;
Reduction in the 24-hour urinary light chain excretion, which still exceeded 200mg/24 hours, maintained for a minimum of 6 weeks;
For patients with non-secretory myeloma only, 25-49% reduction in plasma cells in a bone marrow aspirate and on a trephine biopsy, if biopsy was performed, maintained for a minimum of 6 weeks;
A 25-49% reduction in the size of soft tissue plasmacytomas;
No increase in the size or number of lityc lesions."|Month 9 & Month 18|Intent-to-treat population (those who received at least one dose of study drug)||Participants|||Number
772145|NCT00732641|Secondary|Number of Participants With Partial Response (PR) to Treatment|"PR was defined as:
At least 50% reduction in the level of the serum monoclonal paraprotein, maintained for a minimum of 6 weeks;
Reduction in 24-hour urinary light chain excretion either by ≥ 90% or to < 200 mg, maintained for a minimum of 6 weeks;
For patients with non-secretory myeloma only, ≥ 50% reduction in plasma cells in a bone marrow aspirate and on a trephine biopsy, if biopsy was performed, maintained for a minimum of 6 weeks;
At least 50% reduction in the size of soft tissue plasmacytomas;
No increase in size or number of lytic bone lesions."|Month 9 & Month 18|Intent-to-treat population (those who received at least one dose of study drug)||Participants|||Number
772146|NCT00732641|Secondary|Number of Participants With Complete Response (CR) to Treatment|"CR was defined as:
Absence of the original monoclonal paraprotein in serum and urine by immunofixation, maintained for a minimum of 6 weeks;
<5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy, if biopsy was performed.
No increase in size or number of lytic bone lesions (development of a compression fracture did not include response);
Disappearance of soft tissue plasmocytomas."|Month 9 & Month 18|Intent-to-treat population (those who received at least one dose of study drug)||Participants|||Number
772147|NCT00732641|Secondary|Number of Days of Overall Survival (OS)|"OS was calculated from the date of randomization to the date of death for any
cause. Participants alive at the end of study were censored at the last date they were known to be alive. Participants who were still living at the end of the study were censored on the last date they were known to be alive."|Baseline and up to 5 years (or to the date of the first documented tumor progression or relapse)|Intent-to-treat population (those who received at least one dose of study drug)||Days||95% Confidence Interval|Median
772148|NCT00732641|Primary|Number of Days With Progression Free Survival (PFS)|"PFS was defined as response duration while on maintenance therapy. It was the length of time during and after treatment in which a participant was living with the cancer that did not get worse.
PFS was calculated from the date of randomization to the date of the first documented tumor progression or relapse."|Baseline and up to 5 years (or to the date of the first documented tumor progression or relapse)|Intent-to-treat population (those who received at least one dose of study drug)||Days||95% Confidence Interval|Median
772149|NCT00732654|Primary|Oral Food Challenge Threshold (OFC) Threshold|mg CM protein|Change from baseline to after therapy (up to 18 months)|||mg||Full Range|Median
772150|NCT00732654|Primary|Change in End Point Skin Test|Allergen provoked skin test (mm)|Change from baseline to after therapy (up to 18 months)|||mm||Full Range|Median
772151|NCT00732654|Primary|Change in CM-specific Immunoglobulin G4 (IgG4)|Cow's milk specific IgG4 was measured at baseline and after therapy (kUa/L)|Change from baseline to after therapy (up to 18 months)|||kUa/L||Full Range|Median
772152|NCT00732654|Primary|Change in CM-specific Immunogloblin E (IgE)|Cow's milk specific IgE was measured at baseline and after therapy (kUa/L)|Change from baseline to after therapy (up to 18 months)|Data was not collected for one participant in the SLIT/OIT A group.||kUa/L||Full Range|Median
772153|NCT00732680|Primary|Mean Score of Sino Nasal Outcome Test 22 (SNOT 22)|The SNOT 22 is a validated measure of health related quality of life in sinonasal disease. It is a 22 item questionnaire with each item assigned a score ranging from 0-5. The total score may range from 0-110 and lower scores represent better health related quality of life.|2 weeks after intervention, 2 months|No study data was collected in the study. The Lead investigator moved to a new medical center; the study was stopped when he left.|||||
772154|NCT00732758|Secondary|Collagen Type 1 Cross-linked C-telopeptide (CTx)|Collagen type 1 cross-linked C-telopeptide (CTx) is a marker of bone resorption.|6 months|Intention to treat with participants analyzed by the group to which they were assigned but only analyzing participants with 6 month CTx data.||ng/mL||Standard Deviation|Mean
772155|NCT00732758|Secondary|Osteocalcin (OC)|Marker of bone formation|6 months|Intention to treat with participants analyzed in the group to which they were assigned but only using participants with 6 month OC data available.||ng/mL||Standard Deviation|Mean
772156|NCT00732758|Secondary|Parathyroid Hormone (PTH) Dietary Data||6 months|Intention to treat with participants analyzed by the group to which they were assigned but only analyzing those participants with follow up data for PTH at 6 months.||pg/mL||Standard Deviation|Mean
772157|NCT00732758|Primary|Serum 25-hydroxyvitamin D|Circulating concentration of 25 hydroxyvitamin D is a biomarker of vitamin D status. Vitamin D deficiency was defined as serum 25-hydroxyvitamin D concentrations <20 ng/mL.|6 months|Intention to treat -- participants analyzed based on the group to which they were randomized but only included in the analysis if they had follow up data at 6 months.||ng/mL||Standard Deviation|Mean
772158|NCT00732875|Primary|Number of Subjects Experiencing Any Infection||throughout entire study (61 +/- 28.9 weeks on average)|All participants were included regardless of how long they stayed in the study||participants|||Number
772159|NCT00732875|Primary|Number of Subjects Experiencing Serious Adverse Event|Serious adverse events are defined as death, life-threatening events, persistent or significant disability/incapacity, hospitalization or prolongation of hospitalization and congenital anomalies.|throughout entire study (61 +/- 28.9 weeks on average)|All participants were included regardless of how long they stayed in the study.||participants|||Number
772160|NCT00732875|Primary|Number of Subjects Experiencing Any Adverse Event||throughout entire study (61 +/- 28.9 weeks on average)|All participants were included regardless of how long they stayed in the study.||participants|||Number
772161|NCT00732901|Secondary|Cocaine Positive Urines|Number of urine drug screens positive for cocaine metabolite benzoylecgonine.|5 weeks of treatment|||Positive urine drug screens|||Number
772162|NCT00732901|Secondary|Attentional Bias as Measured by the Cocaine Stroop Task.|Attentional bias is the difference in reaction time to cocaine related words and neutral words. A slower reaction time indicates greater attentional bias.|5 weeks of treatment|||milliseconds||Standard Deviation|Mean
772163|NCT00732901|Primary|Immediate Memory Task|The IMT was used to measure impulsivity. The IMT is a continuous performance test. Subjects were instructed to respond on the computer’s left mouse button when a five-digit number the target stimulus appeared that was exactly like the preceding stimulus. A catch stimulus was a number that differed only slightly from the preceding number. Only one of the five digits was changed its position and value was determined randomly. Responses errors made to catch stimuli were considered commission errors or ‘false alarms’. Immediate Memory Task Commission Errors to catch stimuli were the primary measure of impulsivity in this study. Scale is percentage of overall responses to a catch stimulus that were commission errors, ranging from 0 to 100. Zero would equate to no impulsivity and 100 would equate to 100% impulsive responses.|after acute dose and after chronic administration|Numerical data values are not accessible because PI transferred institutions. See references.|||||
772164|NCT00732940|Secondary|Absolute Change From Baseline in Triglycerides at Week 24||Baseline, 24 Weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.||mmol/L||Standard Error|Mean
772165|NCT00732940|Secondary|Median Percent Change From Baseline in Triglycerides at Week 24||Baseline, 24 weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.||Percentage||Full Range|Median
772166|NCT00732940|Secondary|Median Percent Change From Baseline in Total Cholesterol at Week 24||Baseline, 24 Weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.||Percentage||Full Range|Median
772167|NCT00732940|Secondary|Absolute Change From Baseline in Total Cholesterol at Week 24||Baseline, 24 Weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.||mmol/L||Standard Error|Mean
772168|NCT00732940|Secondary|Median Percent Change From Baseline in HDL at Week 24||Baseline, 24 week|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.||Percentage||Full Range|Median
772169|NCT00732940|Secondary|Absolute Change From Baseline in High Density Lipoproteins (HDL) at Week 24||Baseline, 24 Weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.||mmol/L||Standard Error|Mean
772170|NCT00732940|Secondary|Median Percent Change From Baseline in Anti-dsDNA at Week 24||Baseline, 24 weeks|Analysis population includes only patients positive for anti-dsDNA (≥30 IU/mL) at baseline and must have had a baseline and Week 24 laboratory sample.||Percentage||Full Range|Median
772171|NCT00732940|Secondary|Absolute Change From Baseline in Anti-Double-Stranded DNA (Anti-dsDNA)at Week 24||Baseline, 24 Weeks|Analysis population includes only patients positive for anti-dsDNA (≥30 IU/mL) at baseline and must have had a baseline and Week 24 laboratory sample.||IU/mL||Standard Error|Mean
772172|NCT00732940|Secondary|Median Percent Change From Baseline in Complement C4 at Week 24||Baseline, 24 Weeks|Analysis population includes only patients with low C4 (<16 mg/dL) at baseline and must have had a baseline and Week 24 laboratory sample.||Percentage||Full Range|Median
772173|NCT00732940|Secondary|Absolute Change From Baseline in Complement C4 at Week 24||Baseline, 24 weeks|Analysis population includes only patients with low C4 (<16 mg/dL) at baseline and must have had a baseline and Week 24 laboratory sample.||mg/dL||Standard Error|Mean
772174|NCT00732940|Secondary|Median Percent Change From Baseline in Compliment C3 at Week 24||Baseline, 24 Weeks|Analysis population includes only patients with low C3 (<900 mg/L) at baseline and must have had a baseline and Week 24 laboratory sample.||Percentage||Full Range|Median
772175|NCT00732940|Secondary|Absolute Change From Baseline in Complement C3 at Week 24||Baseline, 24 Weeks|Analysis population includes only patients with low C3 (<900 mg/L) at baseline and must have had a baseline and Week 24 laboratory sample.||mg/L||Standard Error|Mean
772176|NCT00732940|Secondary|Mean Percent Change From Baseline in the SELENA SLEDAI Score at Week 24||Baseline, 24 weeks|LOCF||Percentage||Standard Error|Mean
772177|NCT00732940|Secondary|Absolute Change From Baseline in the Safety of Estrogen in Lupus Erythematosus National Assessment SLE Disease Activity Index (SELENA SLEDAI) Score at Week 24|SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare.|Baseline, 24 Weeks|LOCF||Points on a scale||Standard Error|Mean
772178|NCT00732940|Secondary|Mean Percent Change From Baseline in PGA Score at Week 24.|The PGA is a visual analog scale scored from 0 to 3. A score of 1 corresponds to mild lupus disease activity. A score of 2 correlates with moderate disease activity and a score of 3 with severe disease activity.|Baseline, 24 weeks|LOCF||Percentage||Standard Error|Mean
772179|NCT00732940|Secondary|Absolute Change From Baseline in Physician's Global Assessment (PGA) Score at Week 24|PGA is a visual analog scale scored from 0 to 3. A score of 1 corresponds to mild lupus disease activity. A score of 2 correlates with moderate disease activity and a score of 3 with severe disease activity.|Baseline, 24 Weeks|Last Observation Carried Forward (LOCF)||Scores on a 3-point scale||Standard Error|Mean
772180|NCT00732940|Primary|Median Percent Change From Baseline in CD20+/CD27+ (Memory) B Cells at Week 24||Baseline, 24 Weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.||Percentage||Full Range|Median
772181|NCT00732940|Primary|Absolute Change From Baseline in CD20+/CD27+ (Memory) B Cells at Week 24||Baseline, 24 Weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.||cells/mm^3||Standard Error|Mean
772182|NCT00732940|Primary|Median Percent Change From Baseline in CD20+/CD69+ (Activated) B Cells at Week 24||Baseline, 24 Weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.||Percentage||Full Range|Median
772183|NCT00732940|Primary|Absolute Change From Baseline in CD20+/CD69+ (Activated) B Cells at Week 24||Baseline, 24 Weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.||cells/mL||Standard Error|Mean
772184|NCT00732940|Primary|Median Percent Change From Baseline in CD20+/CD27-(Naive) B Cells at Week 24||Baseline, 24 weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.||Percentage||Full Range|Median
772185|NCT00732940|Primary|Absolute Change From Baseline in CD20+/CD27- (Naive) B Cells at Week 24||Baseline, 24 weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.||cells/mm^3||Standard Error|Mean
772186|NCT00732940|Primary|Median Percent Change From Baseline in CD20+ (Total) B Cells at Week 24.||Baseline, 24 Weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.||Percentage||Full Range|Median
772196|NCT00732992|Secondary|Summary of Best Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST): Number of Participants|Complete response (CR): disappearance of all target lesions; Partial response (PR): >=30% decrease in the sum of the longest dimensions (SLD) of the target lesions taking as a reference the baseline SLD; Progressive disease (PD): >=20% increase in the SLD of the target lesions taking as a reference the smallest SLD recorded since the treatment started, or the appearance of >=1 new lesions; Stable disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as a reference the smallest SLD since the treatment started.|End of study (Up to individual study discontinuation)|Evaluable subjects = defined as all subjects who met all the following 3 requirements: 1) met the eligibility (inclusion and exclusion) criteria, 2) received at least 1 dose of the study drug, and 3) assessed appropriately at the baseline and had a measurable lesion based on the RECIST.||Participants|||Number
772197|NCT00732992|Secondary|Trough Concentrations of Sunitinib, SU012662, and Total Drug (Sunitinib + SU012662) After Coadministration of Sunitinib 50 mg/Day and Pemetrexed 500 mg/m^2 (Cycle 1 Day 1), Followed by Sunitinib 50 mg/Day on Schedule-2/1 at Cycle 1 Day 14 or 15|Trough concentration was defined as observed concentration at 24 hours post dose. SU012662 is an active metabolite of sunitinib.|Cycle 1 Day 14 (or 15): approximately 24 hours after the previous dose|Participants who provided a plasma concentration data was included in the analysis||nanogram/mL||Standard Deviation|Mean
772198|NCT00732992|Secondary|Terminal Phase Elimination Half-Life (T1/2) of Pemetrexed Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1|"Terminal phase elimination half-life was calculated as natural logarithm of 2 (ln2) divided by the rate constant for terminal phase (kel)."|Cycle 2 Day 1: Pre-dose, 10 minutes after the start of infusion (immediately before the end of infusion), and 1, 2, 4, 6, 8, 10, and 24 hours post-dose|Participants who provided a plasma concentration data was included in the analysis.||hours||Standard Deviation|Mean
772199|NCT00732992|Secondary|AUC0-∞ of Pemetrexed Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1|AUC0-∞ = Area under the plasma concentration versus time curve from zero time to infinity was calculated as the sum of AUClast and (Ct*/kel), where Ct* was the estimated concentration at the time of the last quantifiable concentration, kel was terminal phase rate constant that is estimated as the absolute value of the slope of a linear regression during the terminal phase of the natural-logarithm (ln) transformed concentration-time profile.|Cycle 2 Day 1: Pre-dose, 10 minutes after the start of infusion (immediately before the end of infusion), and 1, 2, 4, 6, 8, 10, and 24 hours post-dose|Participants who provided a plasma concentration data was included in the analysis.||microgram*hour/mL||Standard Deviation|Mean
772200|NCT00732992|Secondary|Maximum Concentration of Pemetrexed Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1||Cycle 2 Day 1: Pre-dose, 10 minutes after the start of infusion (immediately before the end of infusion), and 1, 2, 4, 6, 8, 10, and 24 hours post-dose|Participants who provided a plasma concentration data was included in the analysis.||microgram/mL||Standard Deviation|Mean
772201|NCT00732992|Secondary|Tmax of Sunitinib, SU012662, and Total Drug (Sunitinib + SU012662) Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1|Tmax = Time to maximum plasma concentration. SU012662 is an active metabolite of sunitinib.|Cycle 2 Day 1: Pre-dose and 2, 4, 6, 8, 10, and 24 hours post-dose|Participants who provided a plasma concentration data was included in the analysis.||hours||Full Range|Median
772202|NCT00732992|Secondary|AUC 0-24 of Sunitinib, SU012662, and Total Drug (Sunitinib + SU012662) Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1|AUC0-24 = Area under the plasma concentration versus time curve to 24 hours post dose was calculated using the linear/logarithmic trapezoidal method. SU012662 is an active metabolite of sunitinib.|Cycle 2 Day 1: Pre-dose and 2, 4, 6, 8, 10, and 24 hours post-dose|Participants who provided a plasma concentration data was included in the analysis.||nanogram*hour/mL||Standard Deviation|Mean
772203|NCT00732992|Secondary|Trough and Maximum Concentration of Sunitinib, SU012662, and Total Drug (Sunitinib + SU012662) Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1|Trough concentration was defined as observed concentration at 24 hours post dose. SU012662 is an active metabolite of sunitinib.|Cycle 2 Day 1: Pre-dose and 2, 4, 6, 8, 10, and 24 hours post-dose|Participants who provided a plasma concentration data was included in the analysis.||nanogram/mL||Standard Deviation|Mean
772204|NCT00732992|Secondary|"Sunitinib Relative Dose Intensity in the Sunitinib 50 mg/Day Schedule-2/1 Treatment Arm"|Relative dose intensity was defined as percentage of total dose administered over total planned dose in the given period.|Up to Cycle 6|"Full analysis set = defined as all enrolled patients. n = number of participants assessed for the relative dose intensity in the given period."||percent of total planned dose||Full Range|Median
772205|NCT00732992|Secondary|"Sunitinib Relative Dose Intensity in the Sunitinib 37.5 mg/Day Continuous Daily Dosing Treatment Arm"|Relative dose intensity was defined as percentage of total dose administered over total planned dose in the given period.|Up to Cycle 5 (end of study)|"Full analysis set = defined as all enrolled patients. n = number of participants assessed for the relative dose intensity in the given period."||percent of total planned dose||Full Range|Median
772206|NCT00732992|Primary|Number of Participants With Adverse Events|Number of participants with any adverse events, adverse events graded as Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE) Grade 3 or higher , dose limiting toxicities (DLT), serious adverse events, adverse events resulted in discontinuation.|End of study (up to individual discontinuation)|All subjects who received at least 1 dose of the study drug.||Participants|||Number
772207|NCT00733005|Secondary|The Change From Baseline in Average AM/PM PRIOR Total Nasal Symptom Score Over 15 Days|Total nasal symptom score (TNSS) is a composite of 4 symptoms, each is scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total can range from 0 to 12.|15 days of treatment|Standard deviation is pooled.||Units on a scale||Standard Deviation|Least Squares Mean
772208|NCT00733005|Primary|The Change From Baseline in Average AM/PM PRIOR Nasal Congestion Score Over 15 Days.|Nasal congestion was scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe. PRIOR (the subject's status over the previous 12 hours [reflective])|15 days of treatment|Standard deviation is pooled.||Units on a scale||Standard Deviation|Least Squares Mean
772209|NCT00733096|Secondary|Medication Reduction|Number of people who reduced medications|1 month|Patients who underwent epidural steroid injections||participants|||Number
772215|NCT00733135|Secondary|Residual Diameter Stenosis|This endpoint was met when there was less than 30% residual diameter stenosis following treatment with SilverHawk™ /TurboHawk™ plaque excision systems and any adjunctive therapy (if required), as adjudicated by the angiographic core laboratory.|at the end of the procedure|1 lesion not included because there is no angiographic core laboratory post-treatment data available||percentage of lesions|Participants||Number
772216|NCT00733135|Secondary|Technical Procedural Success|"Technical Procedural Success was defined as meeting all of the following requirements:
Less than or equal to 50% residual diameter stenosis at the target lesion(s), as adjudicated by the angiographic core laboratory
No procedure-related Major Adverse Events (MAE), as adjudicated by the Clinical Events Committee (CEC)
No device malfunction causing the procedure to be aborted
Successful delivery and placement of the SpiderFX™ embolic protection device"|at the end of the procedure|Total patient population minus one patient because there was no angiographic post-treatment core lab data available.||percentage of participants|||Number
772217|NCT00733135|Primary|Major Adverse Event Free Rate 30 Days|MAE was defined as a serious adverse event that results in death, acute myocardial infarction, dissection (grade C or greater), clinical perforation, pseudo-aneurysm, thrombosis, distal embolism (clinically relevant), amputation, or clinically-driven target vessel revascularization (TVR), through 30 days post-procedure, as adjudicated by the Clinical Events Committee (CEC).|30 Days|||percentage of participants||95% Confidence Interval|Number
772218|NCT00733135|Primary|Successful Revascularization|Less than or equal to 50% residual diameter stenosis following plaque excision remaining at the target lesion(s), as adjudicated by the angiographic core laboratory|at the end of the procedure|Number of lesions assessed by the angiographic core lab||percentage of lesions|Participants|95% Confidence Interval|Number
772219|NCT00724815|Secondary|Nausea Free at Two Hours|Number of subjects who were nausea free and who had not received any rescue medication before their two-hour assessment.|2 hours post patch activation|Per protocol, the intent-to-treat population was assessed.||participants|||Number
772220|NCT00724815|Secondary|Phonophobia Free at Two Hours|Subjects who were phonophobia free and who had not received any rescue medication before their two-hour assessment.|2 hours post patch activation|Per protocol, the intent-to-treat population was assessed.||participants|||Number
772221|NCT00724815|Secondary|Photophobia Free at Two Hours|Subjects who were photophobia free and who had not received any rescue medication before their two-hour assessment.|2 hours post patch activation|Per protocol, the intent-to-treat population was assessed.||participants|||Number
772222|NCT00724815|Primary|Pain Free at Two Hours|Subjects whose headache severity score equaled zero (0) two hours post patch activation and who had not received any rescue medication before their two-hour assessment.|2 hours post patch activation|Per protocol, the intent-to-treat population was assessed.||participants|||Number
772223|NCT00724854|Secondary|Assessment of Baseline Characteristics in Participants With SVR|Baseline characteristics assessed were age, gender, and genotype.|24 Weeks post-treatment|Participants with SVR||Participants|||Number
772224|NCT00724854|Secondary|Assessment of Response at Treatment Week 48 for Genotypes 2 and 3, and Treatment Week 72 for Genotypes 1, 4, and 5, in Participants With RVR|Participants who achieved RVR at Treatment Week 4 who were considered to have SVR (non-detectable HCV RNA at Treatment Week 48 for genotypes 2 and 3, and Treatment Week 72 for genotypes 1, 4, and 5). Participants from the Mono-infected with HCV group and the Co-infected with HCV and HIV group, were identified as either Genotype 1, 2, 3, 4, or 5.|Treatment Week 48 and Treatment Week 72|Participants who achieved RVR at Treatment Week 4.||Participants|||Number
772225|NCT00724854|Secondary|Number of Participants With RVR Who Also Achieved SVR|RVR was defined as HCV RNA negative after 4 weeks of treatment. SVR was defined as non-detectable HCV RNA 24 weeks or more post-treatment.|Assessed at Treatment Week 4 (RVR) and 24 weeks post-treatment (SVR)|Participants who achieved RVR at Treatment Week 4.||Participants|||Number
772226|NCT00724854|Secondary|Number of Participants Who Achieved Sustained Virologic Response (SVR)|SVR was defined as non-detectable HCV RNA 24 weeks post-treatment.|Assessed at 24 weeks post-treatment|||Participants|||Number
772227|NCT00724854|Primary|Number of Participants With Rapid Virologic Response After 4 Weeks of Treatment|Rapid virologic response (RVR) was defined as Hepatitis C Virus Ribonucleic acid (HCV RNA) negative after 4 weeks of treatment.|Assessed at Treatment Week 4|||Participants|||Number
772228|NCT00724867|Secondary|Percentage of Participants With Improvement in FACIT-Fatigue Scale Score Exceeding the MCID at Indicated Time Points|The FACIT-F scale measures the severity and impact of fatigue on functioning and health related quality of life experienced in the past 7 days. FACIT-Fatigue scale total score was assessed at BL (Day 0), Week 48 in first year, at Week 48 in subsequent years up to 8 years. The level of fatigue is measured by 13 questions assessed on a four-point scale (0=not at all fatigued; 1=a little bit fatigued; 2=somewhat fatigued; 3=quite a bit fatigued; 4=very much fatigued; possible total score of 0 to 52). Percentage of participants with improvement in FACIT-Fatigue scale score exceeding the minimum clinically important difference (MCID) (>=4 points) are summarized. Only those participants available at the specified time points were analyzed ( n=X).|Up to Week 384|MITT Population||Percentage of Participants|||Number
772229|NCT00724867|Secondary|Change From Baseline in FACIT-Fatigue Scale Total Score at Indicated Time Point|The FACIT-F scale measures the severity and impact of fatigue on functioning and health related quality of life experienced in the past 7 days. FACIT-Fatigue scale total score was assessed at BL (Day 0), Wk 48 in first year, at Wk 48 in subsequent Yrs up to 8 Yrs.The level of fatigue is measured by 13 questions assessed on a four-point scale (0=not at all fatigued; 1=a little bit fatigued; 2=somewhat fatigued; 3=quite a bit fatigued; 4=very much fatigued; possible total score of 0 to 52). Change from BL in FACIT-Fatigue scale total score are summarized. The BL is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from BL was calculated as the individual post-BL value minus the BL value. A negative change from BL represents a worsening condition. Only those participants available at the specified time points were analyzed ( n=X).|Up to Week 384|MITT Population||Score on a scale||Standard Deviation|Mean
772416|NCT00725504|Primary|Present Pain Intensity|Present pain intensity was measured using the visual analog scale (VAS). This is scored between 0 (no pain) to 10 (worst possible pain).|Patients completed the VAS of present pain intensity at each infusion level. Each infusion level took approximately one hour, and the assessment was done at the end of the hour (approximately 3 hours total).|||Score||Standard Error|Mean
772230|NCT00724867|Secondary|Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints|The SF-36v2 is a participant-reported survey to measure functional health and well-being. There are 36 items grouped into eight health domains: Vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. SF-36v2 gives a score (0-100) for each of these domains as well as summary score for the physical component score (PCS) and mental component score (MCS) based on the responses by participants. The lower the score the more disability and the higher the score the less disability. The BL is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from BL was calculated as the individual post-BL value minus the BL value. Only those participants available at the specified time points were analyzed ( n=X).|Up to Week 384|MITT Population||Score on a scale||Standard Deviation|Mean
772231|NCT00724867|Secondary|Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Time Point|The SF-36v2 is a participant-reported short form survey to measure functional health and well-being. There are 36 items grouped into eight health domains: Vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. SF-36v2 gives a score (0-100) for each of these domains as well as summary score for the physical component score (PCS) and mental component score (MCS) based on the responses by participants. The lower the score the more disability and the higher the score the less disability. The BL is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from BL was calculated as the individual post-BL value minus the BL value. Only those participants available at the specified time points were analyzed ( n=X).|Up to Week 384|MITT Population||Score on a scale||Standard Deviation|Mean
772232|NCT00724867|Secondary|Percentage of Participants With Worsening in SLICC/ACR Damage Index at Indicated Time Points|Systemic Lupus International Collaborative Clinics/American College of Rheumatology (SLICC/ACR) Damage Index is a tool used to assess non-reversible organ damage in SLE patients. Damage Index is used to assess 12 systems by 41 items. Score is given as 1 or sometimes 2, if occur more than once, so that that the maximum possible score is 47. Higher damage index scores early in disease are associated with a poor prognosis and with increased mortality. Damage index was assessed at BL (Day 0), Week 48 in first year, at Week 48 in subsequent years up to 8 years. Percentage of participants with worsening in damage index (change >0) are summarized. The BL is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Only those participants available at the specified time points were analyzed ( n=X).|Up to Week 384|MITT Population||Percentage of Participants|||Number
772233|NCT00724867|Secondary|Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.|B-cell levels were assessed at Baseline (BL) (Day 0), Week (Wk) 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks and at exit visit. Median percent change from Baseline in absolute B cell subsets (CD20+), CD19+/27BRIGHT/38BRIGHT SLE subset, CD19+20-27hi+ short-lived plasma cells (SLPC), CD20+/138+ plasmacytoid, CD20+/27+ memory, CD20+/27- naïve, CD20+/69+activated, CD20-/138+ plasma cells, Total CD19+ B-cells (CD19+) levels are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Percent change from Baseline is calculated as: 100 x ([Post-Dose Visit Value – Baseline] / Baseline). Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 432|MITT Population||Percentage change||Full Range|Median
772234|NCT00724867|Secondary|Observed B-cell Levels at Indicated Time Points.|B-cell levels were assessed at Baseline (BL) (Day 0), Week (Wk) 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks and at exit visit. Observed absolute B cell subsets (CD20+), CD19+/27BRIGHT/38BRIGHT SLE subset, CD19+20-27hi+ short-lived plasma cells (SLPC), CD20+/138+ plasmacytoid, CD20+/27+ memory, CD20+/27- naïve, CD20+/69+activated, CD20-/138+ plasma cells, Total CD19+ B-cells (CD19+) levels are summarized. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 432|MITT Population||Cell count||Full Range|Median
772235|NCT00724867|Secondary|Percent of Participants With >= 50% Reduction in Proteinuria at Indicated Time Points.|Proteinuria is defined as the presence of an excess of serum proteins in the urine. Trends for reduction in proteinuria in participants receiving belimumab were assessed up to 432 weeks and at Exit visit. Percentage of participants with >= 50% reduction in proteinuria among participants with Baseline proteinuria >0.5 g/24 hour (hr) are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 432|MITT Population||Percentage of Participants|||Number
772236|NCT00724867|Secondary|Percent of Participants With Daily Prednisone Dose Reduction at Indicated Time Points.|Trends for reduction in prednisone use in participants receiving belimumab were observed up to 432 weeks. Percentage of participants with daily prednisone dose reduced to <=7.5 mg/day from >7.5 mg/kg at the Baseline are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 432|MITT Population||Percentage of Participants|||Number
772253|NCT00724867|Primary|Change From Baseline in Hemoglobin at the Indicated Time Points|Hematology parameters were assessed at Baseline (BL) (Day 0), Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in hemoglobin is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MITT Population||Grams per liter||Standard Deviation|Mean
772237|NCT00724867|Secondary|Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points|Complement C3 and C4 levels were assessed at Baseline (BL) (Day 0), 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks and at exit visit in participants with low complements at Baseline (C3 <90 milligrams per decilitre (mg/dL) and C4 <16 mg/dL). Median percent change from Baseline in complement C3 and C4 levels are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Percent change from Baseline is calculated as: 100 x ([Post-Dose Visit Value – Baseline] / Baseline). Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 432|MITT Population||Percent Change||Full Range|Median
772238|NCT00724867|Secondary|Observed Complement C3 and C4 Levels at Indicated Time Points|Complement C3 and C4 levels were assessed at Baseline (BL) (Day 0), at Week 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at exit visit in participants with low complements at Baseline (C3 <90 milligram per deciliter (mg/dL) and C4 <16 mg/dL). Observed complement C3 and C4 levels are summarized. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MITT Population||Milligrams per deciliter||Full Range|Median
772239|NCT00724867|Secondary|Median Percent Change From Baseline in Anti-double Stranded DNA at Indicated Time Points.|Anti-dsDNA levels were assessed at Baseline (BL) (Day 0), 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks and at exit visit in participants who were positive at baseline (anti-dsDNA ≥30 IU/mL). Median percent change from Baseline in anti-dsDNA levels are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Percent change from Baseline is calculated as: 100 x ([Post-Dose Visit Value – Baseline] / Baseline). Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 432|MITT Population||Percentage change||Full Range|Median
772240|NCT00724867|Secondary|Observed Anti-double Stranded DNA Levels at Indicated Time Points.|Anti-double stranded deoxyribonucleic acid (anti-dsDNA) levels were assessed at Baseline (BL) (Day 0), at Week 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks in participants who were positive at baseline (anti-dsDNA >=30 International Units/milliliter [IU/mL]). Observed anti-dsDNA levels are summarized. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 432|MITT Population||International units per milliliter||Full Range|Median
772241|NCT00724867|Secondary|Percentage of Participants Achieving SRI Response at Indicated Time Points|The percentage of participants achieving a SLE Responder Index (SRI) response at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion) are summarized. The BL is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Response is defined as:>=4 point reduction from the BL in the safety of estrogen in lupus national assessment (SELENA) SLE disease activity index (SLEDAI) score and no worsening (increase of <0.30 points from the BL) in Physicians Global Assessment (PGA), and no new British Isles Lupus Assessment Group (BILAG) A organ domain score or 2 new BILAG B organ domain scores compared with the BL. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MIIT Population||Percentage of Participants|||Number
772242|NCT00724867|Secondary|Number of Participants With Serum Immunoglobulins Below the Lower Limit of Normal at Indicated Time Points.|Serum immunoglobulin G (IgG) was collected at Baseline (BL) (Day 0), at Week 24 and Week 48 in first year, at Week 48 in subsequent years up to 8 years and at follow-up (up to 8 weeks post last infusion). Number of participants with serum immunoglobulins below the lower limit of normal (LLN) (<0.5 nanograms per milliliter [ng/mL]) are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 392|MITT Population||Participants|||Number
772243|NCT00724867|Primary|Percentage of Participants With at Least 25% Reduction From Baseline in Creatinine at Indicated Time Points. Amongst Subjects With Abnormal (>124 Umol/L) Creatinine at Baseline by Year Interval.|Serum creatinine was assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Percentage of participants with at least 25% reduction from baseline in creatinine are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MITT Population. Only those subjects with abnormal (>124 umol/L) creatinine at baseline by year interval.||Percentage of Participants|||Number
772244|NCT00724867|Primary|Percentage of Participants With at Least 25% Increase From Baseline in Creatinine at Indicated Time Points.|Serum creatinine was assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Percentage of participants with at least 25% increase from baseline in creatinine are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MITT Population||Percentage of Participants|||Number
772245|NCT00724867|Primary|Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points.|Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was measured at Baseline (BL) (Day 0), at Week 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks and at exit visit. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 432|MITT Population||Millimeters of mercury||Standard Deviation|Mean
772246|NCT00724867|Primary|Number of Participants With the Indicated Immunogenic Response|Immunogenic response was assessed by binding confirmatory assay at Baseline (BL) (Day 0), at Week 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Number of participants with the indicated immunogenic response are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Results of binding confirmatory assay were categorized as negative, persistent positive (defined as a positive immunogenic response that occurs at least 2 consecutive assessments or a single result at the final assessment) or transient positive (defined as a single positive immunogenic response that does not occur at the final assessment). Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MITT Population||Participants|||Number
772247|NCT00724867|Primary|Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points|Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks and at exit visit. Change from Baseline in alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, gamma glutamyl transferase and lactate dehydrogenase is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 432|MITT Population||Units per liter||Standard Deviation|Mean
772248|NCT00724867|Primary|Change From Baseline in BUN/Creatinine at the Indicated Time Points|Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in BUN/creatinine is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MITT Population||Ratio||Standard Deviation|Mean
772249|NCT00724867|Primary|Change From Baseline in Creatinine Clearance at the Indicated Time Points|Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in creatinine clearance is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MITT Population||Milliliters per second||Standard Deviation|Mean
772250|NCT00724867|Primary|Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points|Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in urate, creatinine and bilirubin is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MITT Population||Micromoles per liter||Standard Deviation|Mean
772251|NCT00724867|Primary|Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points|Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in blood urea nitrogen, glucose, calcium, carbon dioxide, chloride, magnesium, phosphate, potassium and sodium is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MITT Population||Millimoles per liter||Standard Deviation|Mean
772252|NCT00724867|Primary|Change From Baseline in Albumin and Protein at the Indicated Time Points|Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in albumin and protein is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MITT Population||Grams per liter||Standard Deviation|Mean
772299|NCT00724893|Secondary|Number of Participants Achieving SVR by Chronic HCV Genotype (Stage 1)|SVR was defined as HCV-RNA negative at ≥22 weeks following EOT. Participants with no viral response information were considered viral response “no”. For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population)||participants|||Number
772254|NCT00724867|Primary|Change From Baseline in Hematocrit at the Indicated Time Points|Hematology parameters were assessed at Baseline (BL) (Day 0), Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in hematocrit is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MITT Population||Percentage||Standard Deviation|Mean
772255|NCT00724867|Primary|Change From Baseline in Erythrocytes at the Indicated Time Points|Hematology parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in erythrocytes is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MITT Population||Trillions cells per liter||Standard Deviation|Mean
772256|NCT00724867|Primary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points|Hematology parameters were assessed at Baseline (BL) (Day 0), Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in basophils, eosinophils, lymphocytes, monocytes, neutrophils, neutrophils segmented and platelets is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MITT Population||Billion cells per liter||Standard Deviation|Mean
772257|NCT00724867|Primary|Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points|Hematology parameters were assessed at Baseline (BL) (Day 0), Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in APTT and PT is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MITT Population||Seconds||Standard Deviation|Mean
772258|NCT00724867|Primary|SAE Rates by System Organ Class (SOC) During the Study|SAE rates by SOC adjusting for participants-years on study drug anytime post Baseline are summarized, which included the follow up visits. Only treatment-emergent SAEs are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. The event rate of an SAE was calculated as the number of events per 100 participant years: Event Rate = 100* Number of Events / participants Years. participants years were calculated as = sum across all participants ([last visit of interval day - first visit of interval day + 1]/365). participants years excluded between study gaps if participant had not started extension study on date of last visit of parent study.|Up to Week 440|MITT Population||Adverse events/100 participant-years|||Number
772259|NCT00724867|Primary|AE Rates by System Organ Class (SOC) During the Study|AE rates by SOC adjusting for participant-years on study drug anytime post Baseline are summarized, which included the follow up visits. Only treatment-emergent adverse events (AEs) are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. The event rate of an AE was calculated as the number of events per 100 participant years: Event Rate = 100* Number of Events / Participant Years. Participant years were calculated as sum across all participants ([last visit of interval day - first visit of interval day + 1]/365). Participant years excluded between study gaps if participant had not started extension study on date of last visit of parent study.|Up Week 440|MITT Population||Adverse events/100 participant-years|||Number
772260|NCT00724867|Primary|Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs)|An AE is defined as any untoward medical occurrence in a participant (par.) temporally associated with the use of a investigational product (IP), whether or not considered related to the IP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an IP. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or is associated with liver injury and impaired liver function. Only those participants available at the specified time points (represented by n=X, in the category titles) were analyzed.|Up to Week 440|Modified Intent to Treat (MIIT) Population: The MITT Population comprised of all the participants enrolled in the study who received at least one dose of IP.||Participants|||Number
772300|NCT00724893|Secondary|Number of Participants Achieving SVR by Liver Fibrosis Stage (Stage 1)|SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response “no”. Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 = significant liver damage, the liver is fibrotic [scarred] and connects with other scarred areas, and F4 = severe damage [cirrhosis] and liver no longer functions properly).|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population)||participants|||Number
772261|NCT00724893|Secondary|Percentage of Compliance for Participants Achieving SVR Based on Medication Adherence Questionnaire (MAQ) (Stage 2)|Compliance was defined as participants taking ≥80% versus <80% of their doses; compliance ≥80% was derived from participants who answered “always” or “most of the time” to Questions 4 (How often do you stick to your medication schedule for your Ribavirin?) and 5 (How often do you stick to your medication schedule for your Redipen [peginterferon] injections?) of the 6-question compliance questionnaire. Percentages are based on the total number of participants within each compliance category. SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response “no”.|Up to 72 weeks|Participants who completed the MAQ questionnaire during the study and achieved SVR||percentage of participants|||Number
772262|NCT00724893|Secondary|Number of Participants Achieving SVR by HIV Status (Stage 2)|"SVR was defined as HCV-RNA negative at six months following EOT. Participants with no viral response information were considered viral response no."|Up to 72 weeks|This analysis was not done.|||||
772263|NCT00724893|Secondary|Number of Participants Achieving EVR by HIV Status (Stage 2)|EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. Participants with no viral response information were considered viral response “no”.|Week 12|This analysis was not done.|||||
772264|NCT00724893|Secondary|Number of Participants Achieving RVR by HIV Status (Stage 2)|RVR was defined as undetectable HCV-RNA after 4 weeks of treatment (window of 2 to 6 weeks). Participants with no viral response information were considered viral response “no”.|Week 4|This analysis was not done.|||||
772265|NCT00724893|Secondary|Number of Participants Achieving SVR by Gender (Stage 2)|SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response “no”.|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population)||participants|||Number
772266|NCT00724893|Secondary|Number of Participants Achieving EVR by Gender (Stage 2)|EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. Participants with no viral response information were considered viral response “no”.|Week 12|All participants who took at least one dose of study medication (ITT Population)||participants|||Number
772267|NCT00724893|Secondary|Number of Participants Achieving RVR by Gender (Stage 2)|RVR was defined as undetectable HCV-RNA after 4 weeks of treatment. Participants with no viral response information were considered viral response “no”.|Week 4|The RVR analysis population comprised 388 participants who took at least one dose of study medication and were evaluated for RVR||participants|||Number
772268|NCT00724893|Secondary|Number of Participants Achieving SVR by Chronic HCV Genotype 1 Subtype (Stage 2)|SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response “no”. For this analysis participants were grouped by their HCV genotype subcategory (1a or 1b); subcategories are the result of a change in the genetic material in the viruses within the genotype.|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population)||participants|||Number
772269|NCT00724893|Secondary|Number of Participants Achieving EVR by Chronic HCV Genotype 1 Subtype (Stage 2)|EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment.SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response “no”. For this analysis participants were grouped by their HCV genotype subcategory (1a or 1b); subcategories are the result of a change in the genetic material in the viruses within the genotype.|Week 12|All participants who took at least one dose of study medication (ITT Population)||participants|||Number
772270|NCT00724893|Secondary|Number of Participants Achieving RVR by Chronic HCV Genotype 1 Subtype (Stage 2)|RVR was defined as undetectable HCV-RNA after 4 weeks of treatment. SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response “no”. For this analysis participants were grouped by their HCV genotype subcategory (1a or 1b); subcategories are the result of a change in the genetic material in the viruses within the genotype.|Week 4|The RVR analysis population comprised 388 participants who took at least one dose of study medication and were evaluated for RVR||participants|||Number
772271|NCT00724893|Secondary|Number of Participants Achieving SVR by Weight (Stage 2)|SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response “no”.|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population)||participants|||Number
772272|NCT00724893|Secondary|Number of Participants Achieving EVR by Weight (Stage 2)|EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. Participants with no viral response information were considered viral response “no”.|Week 12|All participants who took at least one dose of study medication (ITT Population)||participants|||Number
772273|NCT00724893|Secondary|Number of Participants Achieving RVR by Weight (Stage 2)|RVR was defined as undetectable HCV-RNA after 4 weeks of treatment. Participants with no viral response information were considered viral response “no”.|Week 4|The RVR analysis population comprises 388 participants who took at least one dose of study medication and were evaluated for RVR||participants|||Number
772274|NCT00724893|Secondary|Number of Participants Achieving SVR by Liver Fibrosis Score (Stage 2)|SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response “no”. Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 =significant liver damage, the liver becomes fibrotic [scarred] and connects with other scarred areas , and F4 = severe damage [cirrhosis] and liver no longer functions properly).|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population)||participants|||Number
772435|NCT00725621|Primary|Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy|The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.|Maximum of 16 weeks|Remicade-naive participants who received Remicade induction therapy and subsequent maintenance therapy during the observational study.||Days||Full Range|Median
772275|NCT00724893|Secondary|Number of Participants Achieving EVR by Liver Fibrosis Stage (Stage 2)|EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment.SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response “no”. Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 =significant liver damage, the liver becomes fibrotic [scarred] and connects with other scarred areas , and F4 = severe damage [cirrhosis] and liver no longer functions properly).|Week 12|All participants who took at least one dose of study medication (ITT Population)||participants|||Number
772276|NCT00724893|Secondary|Number of Participants Achieving RVR by Liver Fibrosis Stage (Stage 2)|RVR was defined as undetectable HCV-RNA after four weeks of treatment. SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response “no”. Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 =significant liver damage, the liver becomes fibrotic [scarred] and connects with other scarred areas , and F4 = severe damage [cirrhosis] and liver no longer functions properly).|Week 4|The RVR analysis population comprised 388 participants who took at least one dose of study medication and were evaluated for RVR||participants|||Number
772277|NCT00724893|Secondary|Number of Participants Achieving EVR Who Achieved SVR (Stage 2)|EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response “no”.|Week 12|All participants who took at least one dose of study medication and achieved EVR||participants|||Number
772278|NCT00724893|Secondary|Number of Participants Achieving RVR Who Achieved SVR (Stage 2)|RVR was defined as undetectable HCV-RNA after four weeks of treatment. SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response “no”.|Week 4|Participants who achieved RVR||participants|||Number
772279|NCT00724893|Secondary|Number of Participants Achieving SVR by Race (Stage 2)|SVR was defined as HCV-RNA negative at six months after EOT. Participants with no viral response information were considered viral response “no”.|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population)||participants|||Number
772280|NCT00724893|Secondary|Number of Participants Achieving EVR by Race (Stage 2)|EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. Participants with no viral response information were considered viral response “no”.|Week 12|All participants who took at least one dose of study medication (ITT Population)||participants|||Number
772281|NCT00724893|Secondary|Number of Participants Achieving RVR by Race (Stage 2)|RVR was defined as undetectable HCV-RNA after 4 weeks of treatment (window of 2 to 6 weeks). Participants with no viral response information were considered viral response “no”.|Week 4|The RVR analysis population comprised 388 participants who took at least one dose of study medication and were evaluated for RVR||participants|||Number
772282|NCT00724893|Secondary|Number of Participants Achieving EVR (Stage 2)|EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. Participants with no viral response information were considered viral response “no”.|Week 12|All participants who took at least one dose of study medication (ITT Population)||participants|||Number
772283|NCT00724893|Secondary|Number of Participants Achieving Rapid Virologic Response (RVR) (Stage 2)|RVR was defined as undetectable HCV-RNA after 4 weeks of treatment (window of 2 to 6 weeks). Participants with no viral response information were considered viral response “no”.|Week 4|The RVR analysis population comprised 388 participants who took at least one dose of study medication and were evaluated for RVR||participants|||Number
772284|NCT00724893|Secondary|Number of Participants Discontinued From Study Drug Due to Adverse Events by Chronic HCV Genotype (Stage 1)|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment. For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.|Up to 48 weeks|All participants who took at least one dose of study medication (ITT population); no participants had Genotype 5||Participants|||Number
772285|NCT00724893|Secondary|Relapse Rate by HCV Genotype (Stage 1)|The relapse rate was calculated with these parameters: EOT “yes”, EVR evaluation valid, and ≥22 weeks of follow-up data. There were no imputations for EOT or SVR. Participants with no viral response information were considered viral response “no”. For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.|Up to 48 weeks|"All participants who took at least one dose of study medication (ITT population) and had EOT yes and valid EVR evaluation ; no participants had Genotype 5"||Percentage of Participants|||Number
772286|NCT00724893|Secondary|Number of Participants With EVR by Selected Chronic HCV Genotypes (Stage 1)|EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at TW12. Participants with no viral response information were considered viral response “no”. For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.|Week 12|The EVR analysis population comprised participants with HCV genotypes 1, 4, and 6 only, who took at least one dose of study medication; no participants had Genotype 5||Participants|||Number
774920|NCT00753012|Primary|Blood Pressure at Maximum Exertion|Diastolic blood pressure (DBP) at maximum exertion following 3-6 months of stimulant medication, according to cardiopulmonary exercise testing (CPET)|3-6 months|||mmHg||Standard Deviation|Mean
772287|NCT00724893|Secondary|Number of Participants With EOT Response by Chronic HCV Genotype (Stage 1)|EOT response was defined as HCV-RNA negative after 24 weeks of treatment in participants with HCV-RNA Genotype 2 or 3, and after 48 weeks of treatment in participants with Genotype 1, 4, 5, or 6. If there was no EOT information or if it was marked as “not done” then EOT was set to “no”. For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population); no participants had Genotype 5||particpants|||Number
772288|NCT00724893|Secondary|Number of Participants With End of Treatment (EOT) Response (Stage 1)|EOT response was defined as HCV-RNA negative after 24 weeks of treatment in participants with HCV Genotype 2 or 3, and after 48 weeks of treatment in participants with Genotype 1, 4, 5, or 6. If there was no EOT information or if it was marked as “not done” then EOT was set to “no”.|Up to 48 weeks|All participants who took at least one dose of study medication (ITT Population); no participants had Genotype 5||participants|||Number
772289|NCT00724893|Secondary|Number of Participants Achieving SVR by Human Immunodeficiency Virus (HIV) Status (Stage 1)|SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response “no”.|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population)||participants|||Number
772290|NCT00724893|Secondary|Number of Participants Achieving SVR by Race (Stage 1)|SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response “no”.|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population)||participants|||Number
772291|NCT00724893|Secondary|Number of Participants Achieving SVR by Gender (Stage 1)|SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response “no”.|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population)||participants|||Number
772292|NCT00724893|Secondary|Number of Participants Achieving SVR by EVR Type (Stage 1)|EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative after 12 weeks of treatment. SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response “no”.|Up to 72 weeks|The EVR analysis population comprised participants with HCV Genotypes 1, 4, 5, and 6 who took at least one dose of study medication. No participants had Genotype 5.||participants|||Number
772293|NCT00724893|Secondary|Number of Participants Achieving EVR (Stage 1)|EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative after 12 weeks of treatment. Participants with no viral response information were considered viral response “no”.|From Week 10 to Week 14|The EVR analysis population comprised participants with HCV Genotypes 1, 4, and 6 only, who took at least one dose of study medication.||participants|||Number
772294|NCT00724893|Secondary|Number of Participants Achieving SVR by Weight + Chronic HCV Genotype (Stage 1)|SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response “no”. For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population); no participants had Genotype 5||participants|||Number
772295|NCT00724893|Secondary|Number of Participants Achieving SVR by Chronic HCV Genotype + Viral Load (Stage 1)|SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response “no”. Viral load categories were defined as High (≥100,000 Iu/mL) or Low (<100,000 Iu/mL). For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population); no participants had Genotype 5||participants|||Number
772296|NCT00724893|Secondary|Number of Participants Achieving SVR by Chronic HCV Genotype + Liver Fibrosis Stage (Stage 1)|SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response “no”. Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 =significant liver damage, the liver becomes fibrotic [scarred] and connects with other scarred areas, and F4 = severe damage [cirrhosis] and liver no longer functions properly). For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population); no participants had Genotype 5||participants|||Number
772297|NCT00724893|Secondary|Number of Participants Achieving SVR by Weight (Stage 1)|SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response “no”.|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population)||participants|||Number
772298|NCT00724893|Secondary|Number of Participants Achieving SVR by Viral Load (Stage 1)|SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response “no”. Viral load categories were defined as High (≥100,000 Iu/mL) or Low (<100,000 Iu/mL).|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population)||participants|||Number
772807|NCT00734162|Secondary|Change From Baseline in Z-score for Spine BMD at Week 144|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 144|Participants in the Safety Analysis Set with available data were analyzed.||z-score||Standard Deviation|Mean
772301|NCT00724893|Secondary|The Number of Participants Achieving Viral Response at 12 Weeks After EOT by Liver Fibrosis Stage (Stage 1)|Viral response was defined as negative HCV-RNA; evaluation was done 12 weeks (window 10-14 weeks) after EOT. Participants with no viral response information were considered viral response “no”. Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 =significant liver damage, the liver becomes fibrotic [scarred] and connects with other scarred areas, and F4 = severe damage [cirrhosis] and liver no longer functions properly).|Up to 62 weeks|All participants who took at least one dose of study medication (ITT population)||Participants|||Number
772302|NCT00724893|Secondary|The Number of Participants Achieving Viral Response at 12 Weeks After EOT by Chronic HCV Genotype (Stage 1)|Viral response was defined as negative HCV-RNA; evaluation was done 12 weeks (window 10-14 weeks) after EOT. Participants with no viral response information were considered viral response “no”. For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.|Up to 62 weeks|All participants who took at least one dose of study medication (ITT population).||Participants|||Number
772303|NCT00724893|Secondary|The Number of Participants Achieving SVR Excluding Participants Who Discontinued Prior to EVR Evaluation and Participants With Missing Data (Stage 1)|SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response “no”.|Up to 72 weeks|Participants in the ITT population with EVR evaluation at Treatment Week 12 and no missing data||participants|||Number
772304|NCT00724893|Secondary|The Number of Participants Achieving Viral Response at 12 Weeks After EOT, Excluding Participants Who Discontinued Prior to EVR Evaluation and Participants With Missing Data (Stage 1)|Viral response was defined as negative HCV-RNA; evaluation was done 12 weeks (window 10-14 weeks) after EOT. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response “no”.|Up to 62 weeks|Participants in the ITT population with EVR evaluation at Treatment Week 12 and no missing data||Participants|||Number
772305|NCT00724893|Secondary|Number of Participants Achieving SVR, Excluding Participants Who Discontinued Prior to EVR Evaluation (Stage 1)|SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response “no”.|Up to 72 weeks|Participants in the ITT population with EVR evaluation at Treatment Week 12||Participants|||Number
772306|NCT00724893|Secondary|Number of Participants Achieving Viral Response at 12 Weeks After EOT, Excluding Participants Who Discontinued Prior to EVR Evaluation (Stage 1)|Viral response was defined as negative HCV-RNA. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response “no”.|Up to 62 weeks|Participants in the ITT population with EVR evaluation at Treatment Week 12||Participants|||Number
772307|NCT00724893|Secondary|Number of Participants Achieving Viral Response at Any Evaluation Point, Excluding Participants Who Discontinued Treatment Prior to Early Virologic Response (EVR) Evaluation (Stage 1)|Viral response was defined as negative HCV-RNA. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response “no”.|Up to 72 weeks|Participants in the ITT population with EVR evaluation at Treatment Week 12||Participants|||Number
772308|NCT00724893|Secondary|Number of Participants Discontinued From Study Treatment Due to Adverse Events (Stage 1 and Stage 2)|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment|Up to 48 weeks|All participants who took at least one dose of study medication (ITT Population)||participants|||Number
772309|NCT00724893|Primary|Number of Participants Achieving SVR (Stage 2)|SVR was defined as HCV-RNA negative at six months after EOT. Participants with no viral response information were considered viral response “no”.|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population)||participants|||Number
772310|NCT00724893|Primary|Number of Participants Achieving Sustained Viral Response (SVR) (Stage 1)|This is a measure of the number of participants who achieved SVR, defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response “no”.|Up to 72 weeks|All participants who took at least one dose of study medication (ITT population)||Participants|||Number
772311|NCT00724893|Primary|Number of Participants Achieving Viral Response at 12 Weeks After EOT (Stage 1)|This is a measure of the number of participants achieving a viral response (negative HCV-RNA) at 12 weeks (window 10-14 weeks) after EOT. Participants with no viral response information were considered viral response “no”.|Up to 62 weeks|All participants who took at least one dose of study medication (ITT population)||Participants|||Number
772312|NCT00724893|Primary|Number of Participants Achieving Viral Response at Any Evaluation Point (Stage 1)|This is a measure of the number of participants achieving a viral response (negative hepatitis C virus ribonucleic acid [HCV-RNA]) at either of the follow-up evaluation time points (12 weeks [window 10-14 weeks] or ≥22 weeks after the end of treatment (EOT). Participants with no viral response information were considered viral response “no”.|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population)||participants|||Number
772313|NCT00724932|Secondary|Number of Participants Who Experienced Pre-treatment Non-serious Adverse Events (AEs) and Post-treatment Non-serious AEs|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body, whether or not considered related to the use of the product. Participants were monitored for occurrence AEs for up to 7 days after last dose IMP. Pre-treatment refers to the period from signing of the informed consent up to start of IMP administration. Post-treatment refers to the period from start of IMP administration to 7 days after IMP administration.|From signing of informed consent to end of trial (7 days after surgery)|The AST Population consisted of all randomized participants who received IMP.||participants|||Number
772314|NCT00724932|Secondary|Number of Participants Who Experienced Pre-treatment Serious Adverse Events (SAEs) and Post-treatment SAEs|"An SAE is defined as any untoward medical occurrence that at any dose: results in death; is life-threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or is a congenital anomaly/birth defect.
Participants were monitored for occurrence SAEs for up to 7 days after last dose IMP. Pre-treatment refers to the period from signing of the informed consent up to start of IMP administration. Post-treatment refers to the period from start of IMP administration to 7 days after IMP administration."|From signing of informed consent to end of trial (7 days after surgery)|The All-Subjects-Treated (AST) Population consisted of all randomized participants who received IMP.||participants|||Number
772315|NCT00724932|Other Pre-specified|Time From PACU Admit to Actual PACU Discharge|The time of PACU admit was defined as the actual time the participant was admitted to the PACU. The time of PACU discharge was defined as the actual time the participant was discharged from the PACU.|From PACU admit to actual PACU discharge (up to ~4.3 hours)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.||minutes||Standard Deviation|Mean
772316|NCT00724932|Other Pre-specified|Time From PACU Admit to PACU Discharge Ready|The time of PACU admit was defined as the actual time the participant was admitted to the PACU. The time of PACU discharge ready was defined as the time at which the participant had a Modified Aldrete Score >=9. The Modified Aldrete Score was to be assessed at PACU arrival, at 5, 15, 30, 45, 60 minutes after PACU arrival and every 15 minutes thereafter (if applicable) until the participant was ready to be discharged from the PACU. The Modified Aldrete Postoperative Recovery Score (range = 0-10) is calculated based on scores of 0 to 2 each for Activity, Respiration, Circulation, Consciousness and Oxygen Saturation, with a higher score indicating increased postoperative recovery.|From PACU admit to PACU discharge ready (up to ~25 minutes)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.||minutes||Standard Deviation|Mean
772317|NCT00724932|Other Pre-specified|Time From Actual Operating Room Discharge to Actual PACU Discharge|The time of Operating Room discharge was defined as the actual time the participant was discharged from the Operating Room. The time of PACU discharge was defined as the actual time the participant was discharged from the PACU.|From actual Operating Room discharge to actual PACU discharge (up to ~4.4 hours)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.||minutes||Standard Deviation|Mean
772318|NCT00724932|Other Pre-specified|Time From Actual Operating Room Discharge to PACU Discharge Ready|The time of Operating Room discharge was defined as the actual time the participant was discharged from the Operating Room. The time of PACU discharge ready was defined as the time at which the participant had a Modified Aldrete Score >=9. The Modified Aldrete Score was to be assessed at PACU arrival, at 5, 15, 30, 45, 60 minutes after PACU arrival and every 15 minutes thereafter (if applicable) until the participant was ready to be discharged from the PACU. The Modified Aldrete Postoperative Recovery Score (range = 0-10) is calculated based on scores of 0 to 2 each for Activity, Respiration, Circulation, Consciousness and Oxygen Saturation, with a higher score indicating increased postoperative recovery.|From actual Operating Room discharge to PACU discharge ready (up to ~30 minutes)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.||minutes||Standard Deviation|Mean
772319|NCT00724932|Other Pre-specified|Time From Operating Room Discharge Ready to Actual PACU Discharge|The time of Operating Room discharge ready was defined as time at which the participant had T4/T1 ratio of >=0.9 and the participant's wound dressing was in place. The time of PACU discharge was defined as the actual time the participant was discharged from the PACU.|From Operating Room discharge ready to actual PACU discharge (up to ~4.5 hours)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.||minutes||Standard Deviation|Mean
772320|NCT00724932|Other Pre-specified|Time From Operating Room Discharge Ready to Post Anesthetic Care Unit (PACU) Discharge Ready|The time of Operating Room discharge ready was defined as time at which the participant had T4/T1 ratio of >=0.9 and the participant's wound dressing was in place. The time of PACU discharge ready was defined as the time at which the participant had a Modified Aldrete Score >=9. The Modified Aldrete Score was to be assessed at PACU arrival, at 5, 15, 30, 45, 60 minutes after PACU arrival and every 15 minutes thereafter (if applicable) until the participant was ready to be discharged from the PACU. The Modified Aldrete Postoperative Recovery Score (range = 0-10) is calculated based on scores of 0 to 2 each for Activity, Respiration, Circulation, Consciousness and Oxygen Saturation, with a higher score indicating increased postoperative recovery.|From Operating Room discharge ready to PACU discharge ready (up to ~33 minutes)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.||minutes||Standard Deviation|Mean
772321|NCT00724932|Other Pre-specified|Time From Tracheal Extubation to Actual Operating Room Discharge|The time of tracheal extubation was defined as the actual time at which the participant was extubated. The time of Operating Room discharge was defined as the actual time at which the participant was discharged from the Operating Room.|From tracheal extubation to actual OR discharge (up to ~5 minutes)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.||minutes||Standard Deviation|Mean
772322|NCT00724932|Other Pre-specified|Time From Tracheal Extubation to Operating Room Discharge Ready|The time of tracheal extubation was defined as the actual time at which the participant was extubated. The time of Operating Room discharge ready was defined as time at which the participant had T4/T1 ratio of >=0.9 and the participant's wound dressing was in place.|From tracheal extubation to Operating Room discharge ready (up to ~1 minute)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.||minutes||Standard Deviation|Mean
772323|NCT00724932|Other Pre-specified|Time From Start of IMP Administration to Actual Operating Room Discharge|The time of IMP administration was defined as the actual time at which IMP administration was started. The time of Operating Room discharge was defined as the actual time at which the participant was discharged from the Operating Room.|From start of IMP administration to actual Operating Room discharge (up to ~26 minutes)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.||minutes||Standard Deviation|Mean
781595|NCT00795951|Primary|Diagnostic Performance: Potassium Dichromate|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application|||participants|||Number
772324|NCT00724932|Other Pre-specified|Time From Start of IMP Administration to Operating Room Discharge Ready|The time of IMP administration was defined as the actual time at which IMP administration was started. The time of Operating Room discharge ready was defined as time at which the participant had T4/T1 ratio of >=0.9 and the participant's wound dressing was in place.|From start of IMP administration to Operating Room discharge ready (up to ~21 minutes)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.||minutes||Standard Deviation|Mean
772325|NCT00724932|Other Pre-specified|Time From Start of IMP Administration to Tracheal Extubation|The time of IMP administration was defined as the actual time at which IMP administration was started. The time of tracheal extubation was defined as the actual time at which the participant was extubated.|From start of IMP administration to tracheal extubation (up to ~21 minutes)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.||minutes||Standard Deviation|Mean
772326|NCT00724932|Other Pre-specified|Time From Start of IMP Administration to T4/T1 Ratio of <=0.60, >0.60 - <=0.70, >0.70 - <=0.80, >0.80 - <0.90 and >=0.90|The time of IMP administration was defined as the actual time at which IMP administration was started.|From start of IMP administration to recovery of the T4/T1 ratio to the designated value (ranging from ~1 minute to ~10 minutes)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement. Data not collected. In Protocol Amendment 2, this outcome measure was removed.|||||
772327|NCT00724932|Other Pre-specified|Time From Operating Room Discharge Ready to Actual Operating Room Discharge|The time of Operating Room discharge ready was defined as time at which the participant had T4/T1 ratio of >=0.9 and the participant's wound dressing was in place. The time of Operating Room discharge was defined as the actual time the participant was discharged from the Operating Room.|From Operating Room discharge ready to actual Operating Room discharge (up to ~5 minutes)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.||minutes||Standard Deviation|Mean
772328|NCT00724932|Other Pre-specified|Time From Operating Room Admission to Actual Operating Room Discharge|The time of Operating Room admission was defined as the time at which the participant was physically placed into the Operating Room. The time of Operating Room discharge was defined as the actual time the participant was discharged from the Operating Room.|From Operating Room admission to actual Operating Room discharge (up to ~3 hours)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.||minutes||Standard Deviation|Mean
772329|NCT00724932|Other Pre-specified|Time From Operating Room Admission to Operating Room Discharge Ready|The time of Operating Room admission was defined as the time at which the participant was physically placed into the Operating Room. The time of Operating Room discharge ready was defined as time at which the participant had T4/T1 ratio of ≥0.9 and the participant's wound dressing was in place.|From Operating Room admission to Operating Room discharge ready (up to ~3 hours)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.||minutes||Standard Deviation|Mean
772330|NCT00724932|Other Pre-specified|Number of Female Participants or Partners of Male Participants Who Became Pregnant During Study|Thirty days after administration of IMP, female participants of childbearing potential were asked whether they became pregnant during the trial and male participants were asked whether their partner (if of childbearing potential) became pregnant during the trial.|Up to 30 days after IMP administration|The AST Population consisted of all randomized participants who received IMP.||participants|||Number
772331|NCT00724932|Other Pre-specified|Monitoring of Clinical Signs of Recovery According to Routine Anesthetic Procedures at the Trial Sites|The monitoring of clinical signs of recovery was to be conducted based on the routine anesthetic procedures at each site.|Up to PACU discharge (up to ~4.5 hours)|The AST Population consisted of all randomized participants who received IMP.||participants|||Number
772332|NCT00724932|Other Pre-specified|Number of Participants With Events Due to a Possible Interaction of Sugammadex With Endogenous Compounds or With Exogenous Compounds Other Than Rocuronium|Any evidence of events due to a possible interaction of sugammadex with endogenous compounds or with exogenous compounds other than rocuronium, was to be recorded.|Up to 7 days after IMP administration|The AST Population consisted of all randomized participants who received sugammadex. Participants who received neostigmine were excluded from this analysis.||participants|||Number
772333|NCT00724932|Other Pre-specified|Number of Participants With Clinical Evidence of Reoccurrence of Neuromuscular Blockade or Residual Neuromuscular Blockade (Routine Oxygen Saturation by Pulse Oximetry and Breath Frequency Measurement)|Clinical evidence of reoccurrence of NMB or residual NMB was assessed by oxygen saturation (by pulse oximetry) and breath frequency measurements as per routine practice after anesthesia and neuromuscular monitoring.|Up to 24 hours after IMP administration|The AST Population consisted of all randomized participants who received IMP.||participants|||Number
772334|NCT00724932|Other Pre-specified|Number of Participants With Reoccurrence of Neuromuscular Blockade Based on the Train-of-Four- (TOF-) Watch® SX Recording (i.e. a Decline in T4/T1 Ratio From >=0.9 to <0.8 in at Least Three Consecutive TOF Values)|Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (heights) of the 1st and 4th twitches, respectively, after TOF stimulation. The T4/T1 Ratio is expressed as a decimal of up to 1.0. A higher ratio indicates greater recovery from NMB. A decline in the T4/T1 ratio from >=0.9 (indicating a recovery from NMB) to <0.8 for at least three consecutive TOF values was considered to be a reoccurrence of NMB.|Up to 30 minutes after IMP administration|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.||participants|||Number
772344|NCT00724932|Other Pre-specified|Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.5 and 0.6|Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0). Faster times to recovery of the T4/T1 Ratios to 0.5 and 0.6 indicate faster recoveries from NMB.|From start of IMP administration to recovery of T4/T1 Ratio to 0.5 and 0.6 (ranging from ~1 minute to ~4 minutes)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement. No imputation was done for missing times to recovery of the T4/T1 ratio to 0.5 and 0.6.||minutes||95% Confidence Interval|Geometric Mean
772335|NCT00724932|Other Pre-specified|Number of Participants With Train-of-Four- (TOF-) Watch® SX and Arm Board Related Adverse Events|Events were to be collected for the entire period of neuromuscular transmission monitoring and were defined as an occurrence that resulted or could have resulted in: death; a serious deterioration in the state of health of a user; an occurrence which might, if it recurred, lead to death or serious deterioration in health; inaccuracy as well as any inadequacy in the labeling or instructions which could cause misuse or incorrect maintenance or adjustment which might lead to a death or serious deterioration in health; an examination of the medical device or the information supplied with the medical device indicated some factor with the potential for an incident involving death or serious deterioration in health; malfunction or deterioration in characteristics and/or performance of a medical device, which might lead to death, or serious deterioration in health; technical/medical recalls involving risk of death or serious deterioration in the state of health of the user.|From induction of anesthesia to recovery from NMB (up to ~3 hours)|The AST Population consisted of all randomized participants who received IMP.||participants|||Number
772336|NCT00724932|Other Pre-specified|Number of Participants Who Had Physical Examinations|Physical examinations were to be conducted at screening (within 7 days prior to surgery) and at the post-anesthetic visit (the day after surgery).|At screening (within 7 days prior to surgery) and at the post-anesthetic visit (the day after surgery)|The AST Population consisted of all randomized participants who received IMP. As there was no specific physical examination case report form used in this study, data on whether or not a physical examination was conducted were not recorded.|||||
772337|NCT00724932|Secondary|Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.8|Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0). A faster time to recovery of the T4/T1 Ratio to 0.8 indicates a faster recovery from NMB.|From start of IMP administration to recovery of T4/T1 Ratio to 0.8 (ranging from ~2 minutes to ~6 minutes)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement. Imputed recovery times were used in cases of missing recovery times.||minutes||95% Confidence Interval|Geometric Mean
772338|NCT00724932|Other Pre-specified|Mean Heart Rate|Heart Rate was measured at screening, before start of rocuronium administration, before start of IMP administration, at 2, 5, 10, 30 minutes post-IMP administration, and at the post-anesthetic visit (the day after surgery).|At screening, pre-rocuronium, pre-IMP, at 2, 5, 10, and 30 minutes post-IMP, and at the post-anesthetic visit (the day after surgery)|The AST Population consisted of all randomized participants who received IMP.||beats per minute||Standard Deviation|Mean
772339|NCT00724932|Other Pre-specified|Mean Diastolic Blood Pressure|Diastolic Blood Pressure was measured at screening, before start of rocuronium administration, before start of IMP administration, at 2, 5, 10, 30 minutes post-IMP administration, and at the post-anesthetic visit (the day after surgery).|At screening, pre-rocuronium, pre-IMP, at 2, 5, 10, and 30 minutes post-IMP, and at the post-anesthetic visit (the day after surgery)|The AST Population consisted of all randomized participants who received IMP.||mm Hg||Standard Deviation|Mean
772340|NCT00724932|Other Pre-specified|Mean Systolic Blood Pressure|Systolic Blood Pressure was measured at screening, before start of rocuronium administration, before start of IMP administration, at 2, 5, 10, 30 minutes post-IMP administration, and at the post-anesthetic visit (the day after surgery).|At screening, pre-rocuronium, pre-IMP, at 2, 5, 10, and 30 minutes post-IMP, and at the post-anesthetic visit (the day after surgery)|The AST Population consisted of all randomized participants who received IMP.||mm Hg||Standard Deviation|Mean
772341|NCT00724932|Other Pre-specified|Time From Start of Administration of the Last Dose of Rocuronium to the Time of Reappearance of T2 in the 50 μg.Kg-1 Neostigmine Group|The time of reappearance of T2 refers to when the second twitch reappears after TOF stimulation. Reappearance of T2 was the target depth of NMB at which neostigmine was to be administered.|From last dose of rocuronium to reappearance of T2 (up to ~26 minutes)|The ITT Population consisted of all randomized participants who received neostigmine and had at least one efficacy measurement. The participants who received sugammadex were not included in this analysis.||minutes||95% Confidence Interval|Geometric Mean
772342|NCT00724932|Other Pre-specified|Time From Start of Administration of the Last Dose of Rocuronium to the Time of 1-2 PTC in the 4.0 mg.Kg-1 Sugammadex Group|The time of 1-2 PTC refers to when 1-2 twitches are generated after tetanic stimulation. Time to 1-2 PTC is the time point of the last single twitch >0 or baseline (in case of noise or direct stimulation) within the sequence of a PTC measurement. 1-2 PTC was the target depth of NMB at which sugammadex was to be administered.|From last dose of rocuronium to 1-2 PTC (up to ~9 minutes)|The ITT Population consisted of all randomized participants who received sugammadex and had at least one efficacy measurement. The participants who received neostigmine were not included in this analysis.||minutes||95% Confidence Interval|Geometric Mean
772343|NCT00724932|Other Pre-specified|Time From Start of Administration of the Last Dose of Rocuronium to Recovery of the T4/T1 Ratio to 0.5, 0.6, 0.7, 0.8 and 0.9|Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0). A faster time to recovery of the T4/T1 Ratio indicates a faster recovery from NMB.|From start of last dose of rocuronium to recovery of T4/T1 Ratio to 0.5, 0.6, 0.7, 0.8 and 0.9 (ranging from ~12 minutes to ~36 minutes)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement. No imputation was done for missing times from administration of last dose of rocuronium to recovery of the T4/T1 ratio to 0.5, 0.6, 0.7, 0.8 and 0.9.||minutes||95% Confidence Interval|Geometric Mean
772359|NCT00725010|Primary|Safety: Number of Adverse Events in the Indicated Categories||Weekly during the concomitant treatment phase, and then monthly during the monotherapy phase|||Adverse Events|||Number
772360|NCT00725049|Secondary|Cost Analysis||3 years||12/2017||||
772361|NCT00725049|Primary|Integration Success of Implant|Number of enrolled and treated patients with integrated implants (no mobility detected) at time of analysis.|3 years|Number of participants used in analysis selected as per protocol||participants|Dental implants||Number
772345|NCT00724932|Secondary|Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.7|Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0). A faster time to recovery of the T4/T1 Ratio to 0.7 indicates a faster recovery from NMB.|From start of IMP administration to recovery of T4/T1 Ratio to 0.7 (ranging from ~2 minutes to ~5 minutes)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement. Imputed recovery times were used in cases of missing recovery times.||minutes||95% Confidence Interval|Geometric Mean
772346|NCT00724932|Primary|Time From Start of Administration of Investigational Medicinal Product (IMP, Sugammadex or Neostigmine) to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9|Neuromuscular functioning was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from neuromuscular blockade (NMB). In this study, twitch responses were recorded until the T4/T1 Ratio reached >= 0.9, the minimum acceptable ratio that indicated recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.9 indicates a faster recovery from NMB.|From start of IMP administration to recovery of T4/T1 ratio to 0.9 (ranging from ~2 minutes to ~9 minutes)|The Intent-To-Treat (ITT) Population consisted of all randomized participants who received IMP and had at least one efficacy measurement. Imputed recovery times were used in cases of missing times.||minutes||95% Confidence Interval|Geometric Mean
772347|NCT00724945|Primary|Subject Vision|"Subjects responded to How would you rate the overall quality of vision with these study contact lenses using the following scale: 1=poor, 2=fair, 3=good, 4=very good, 5=excellent."|after 1 week wear|||Scores on a scale||Standard Error|Least Squares Mean
772348|NCT00724945|Primary|Near Visual Acuity|This outcome measures vision while subjects are looking at objects near to them and is measured in logMARs. logMAR is the logarithm of the minimum angle of resolution.The ideal is 0.0 and represents 20/20 Snellen acuity.logMAR values >0.00 indicate vision poorer than ideal and values<0.0 indicate vision greater than ideal.|after 1 week wear|||logMAR units||Standard Error|Least Squares Mean
772349|NCT00724945|Primary|Distance Visual Acuity|This outcome measures vision while subjects are looking at objects in the distance and is measures in logMARs.logMAR is the logarithm of the minimum angle of resolution.The ideal is 0.0 and represents 20/20 Snellen acuity.logMAR values >0.00 indicate vision poorer than ideal and values<0.0 indicate vision greater than ideal|after 1 week of wear|Analysis includes participants who completed the study per protocol.||logMAR units||Standard Error|Least Squares Mean
772350|NCT00724958|Primary|Total Dose of Infliximab Per Participant Within the Observation Period|Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval).|up to 2 years|315 of infliximab-naive participants were treated in the active phase of the study. Of these, 191 participants received induction therapy (Weeks 0, 2, and 6); 27 received only induction therapy, 132 received induction therapy and subsequent maintenance therapy, and 32 received induction therapy and subsequent episodic therapy.||mg/kg||Standard Deviation|Mean
772351|NCT00724958|Primary|Median Dose of Infliximab Per Participant Within the Observation Period|Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval).|up to 2 years|n = number of infliximab-naive participants||mg/kg||Full Range|Median
772352|NCT00724958|Primary|Average Dose of Infliximab Per Participant Within the Observation Period|Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval).|up to 2 years|n = number of infliximab-naive participants||mg/kg||Standard Deviation|Mean
772353|NCT00724958|Secondary|Assessment of the Disease Activity Before Treatment and During Therapy With Remicade Via Harvey Bradshaw Index (HBI) in an Extended Patient Group of 200 Patients.|HBI consists of only clinical parameters (general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications). HBI is a score on a scale; <5 (remission), 5-7 (mild disease), 8-16 (moderate disease), >16 (severe disease).|5 years|207 participants had disease activity analyzed using Harvey-Bradshaw Index (HBI)||Score on a scale||Standard Deviation|Mean
772354|NCT00724958|Primary|Median Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy)|Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval).|up to 2 years|n = number of infliximab-naive participants||Days||Full Range|Median
772355|NCT00724958|Primary|Mean Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy)|Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval).|up to 2 years|n = number of infliximab-naive participants||Days||Standard Deviation|Mean
772356|NCT00724984|Primary|Phase II: Overall Response Rate (CR+PR)||From first response assessment (day 22 to 28 of Cycle 2) to last response assessment on day 22-28 in even-numbered cycles|||Percentage of Participants||95% Confidence Interval|Number
772357|NCT00724984|Primary|Phase I (Dose Escalation Phase): MTD and DLTs of PCI-24781 Administered Twice Daily (BID) Measure: Disease Response|Number of patients experienced DLT in each cohort|From the Date of PCI-24781 first administration to Cycle 2 Day 1|||participants|||Number
772358|NCT00725010|Primary|Number of Participants Who Discontinued Due to Toxicity||Weekly during the concomitant treatment phase, and then monthly during the monotherapy phase|||Participants|||Number
786180|NCT00833690|Secondary|Serum Urate|From blood sample drawn after taking study drug that day|Visit 12 (Month 24; 720 +/- 7 days after Baseline Visit)|||mg/dL||Standard Deviation|Mean
772362|NCT00725075|Secondary|Change From Baseline in Extrapyramidal Symptoms Rating Scale Score at Week 12|The abbreviated Extrapyramidal Symptoms Rating Scale (ESRS-A) was a sum of the severity rating of a 24-item instrument assessing four types of movement disorders: parkinsonism, dystonia, dyskinesia, and akathisia. Each item was rated on a 7-point scale, from 0=absent to 6=severe. Higher scores indicated more impairment. A negative change from baseline indicated an improvement.|Baseline and Week 12|All randomized participants who received ≥1 dose of study therapy.||Score on a Scale||Standard Deviation|Mean
772363|NCT00725075|Secondary|Change From Baseline in Composite Memory Score at Week 12|Composite memory was a composite of verbal memory and visual memory and was measured by computer using the CNS-Vital Signs Neurocognitive Test Battery. The raw score was the sum of correct responses. The standard scores were normalized from raw scores and presented an age-matched score relative to a normative comparison database. Higher scores were better.|Baseline and Week 12|All randomized participants who received ≥1 dose of study therapy and completed at least 8 weeks of treatment.||Score on a Scale||Standard Deviation|Mean
772364|NCT00725075|Secondary|Change From Baseline in Executive Functioning Score at Week 12|Executive functioning was measured by computer using the CNS-Vital Signs Neurocognitive Test Battery-Shifting Attention Test. The participant matched geometric shapes either by shape or color. The raw score was the sum of correct responses minus errors. The standard scores were normalized from raw scores and presented an age-matched score relative to a normative comparison database. Higher scores were better.|Baseline and Week 12|All randomized participants who received ≥1 dose of study therapy and completed at least 8 weeks of treatment.||Score on a Scale||Standard Deviation|Mean
772365|NCT00725075|Secondary|Change From Baseline in Sustained Attention Score at Week 12|Sustained attention was measured by computer using the CNS-Vital Signs Neurocognitive Test Battery-4-Part Continuous Performance Test. The participant was asked to identify a target shape/color when presented with a battery of different geometric shapes/colors. Only Parts 2 to 4 of the 4 Part Continuous Performance Test contributed towards the sustained attention score. The raw score was the sum of correct responses minus errors. The standard scores were normalized from raw scores and presented an age-matched score relative to a normative comparison database. Higher scores were better.|Baseline and Week 12|All randomized participants who received either MK-8435 (Org 25935) or placebo and who completed at least 8 weeks of treatment.||Score on a Scale||Standard Deviation|Mean
772366|NCT00725075|Secondary|Change From Baseline in Working Memory Score at Week 12|Working memory was measured by computer using the CNS-Vital Signs Neurocognitive Test Battery-4-Part Continuous Performance Test. The participant was presented with targets and remembered target presentation sequencing in order to respond to the directions. Only Part 4 of the 4 Part Continuous Performance Test contributed towards the working memory score. The raw score was the sum of correct responses minus errors. The standard scores were normalized from raw scores and presented an age-matched score relative to a normative comparison database. Higher scores were better.|Baseline and Week 12|All randomized participants who received either MK-8435 (Org 25935) or placebo and who completed at least 8 weeks of treatment.||Score on a Scale||Standard Deviation|Mean
772367|NCT00725075|Secondary|Change From Baseline in Speed of Complex Information Processing Score at Week 12|Speed of complex information processing was measured by computer using the CNS-Vital Signs Neurocognitive Test Battery-Symbol-digit Coding Test. The participant linked numbers to digits. The test consisted of serial presentations of screens, each containing a bank of 8 symbols above and 8 empty boxes below. The participant typed the number that corresponded to the symbol highlighted. The raw score was the processing time in milliseconds. The standard scores were normalized from raw scores and presented an age-matched score relative to a normative comparison database. Higher scores were better.|Baseline and Week 12|All randomized participants who received either MK-8435 (Org 25935) or placebo and who completed at least 8 weeks of treatment.||Score on a Scale||Standard Deviation|Mean
772368|NCT00725075|Secondary|Change From Baseline in Visual Memory Score at Week 12|Visual memory was measured by computer using the CNS-Vital Signs Neurocognitive Test Battery. The participant remembered 15 geometric figures within a field of 15 distractors immediately and after a twenty minute delay. The raw score was the sum of correct responses. The standard scores were normalized from raw scores and presented an age-matched score relative to a normative comparison database. Higher scores were better.|Baseline and Week 12|All randomized participants who received either MK-8435 (Org 25935) or placebo and who completed at least 8 weeks of treatment.||Sore on a Scale||Standard Deviation|Mean
772369|NCT00725075|Secondary|Change From Baseline in Verbal Memory Score at Week 12|Verbal memory was measured by computer using the CNS-Vital Signs Neurocognitive Test Battery. The participant remembered 15 words within a field of 15 distractors immediately and after a twenty minute delay. The raw score was the sum of correct responses. The standard scores were normalized from raw scores and presented an age-matched score relative to a normative comparison database. Higher scores were better.|Baseline and Week 12|All randomized participants who received either MK-8435 (Org 25935) or placebo and who completed at least 8 weeks of treatment.||Score on a Scale||Standard Deviation|Mean
772370|NCT00725075|Secondary|Change From Baseline in Non-Verbal Reasoning Score at Week 12|Non-verbal reasoning was measured by computer using the CNS-Vital Signs Neurocognitive Test Battery. The participant solved 15 visual analogies composed of geometric 2x2, 3x3, or 4x4 puzzles by choosing the most appropriate geometric figure that solved the matrix. The raw score was the sum of correct responses minus errors. The standard scores were normalized from raw scores and presented an age-matched score relative to a normative comparison database. Higher scores were better.|Baseline and Week 12|All randomized participants who received either MK-8435 (Org 25935) or placebo and who completed at least 8 weeks of treatment.||Score on a Scale||Standard Deviation|Mean
772371|NCT00725075|Secondary|Change From Baseline in Perception of Emotions Score at Week 12|Perception of emotion was measured by computer using the CNS-Vital Signs Neurocognitive Test Battery. The participant identified different emotional states (happy, sad, angry, and calm [neutral]) presented in pictures of faces by choosing the appropriate word for the emotion. The raw score was the sum of correct responses minus errors. The standard scores were normalized from raw scores and presented an age-matched score relative to a normative comparison database. Higher scores were better.|Baseline and Week 12|All randomized participants who received either MK-8435 (Org 25935) or placebo and who completed at least 8 weeks of treatment.||Score on a Scale||Standard Deviation|Mean
781596|NCT00795951|Primary|Diagnostic Performance: Wool Alcohol|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application|All enrolled subjects||participants|||Number
772372|NCT00725075|Secondary|Change From Baseline in the Calgary Depression Scale for Schizophrenia (CDSS) at Week 12|CDSS was a 9-item clinician-rated instrument used to evaluate depression in participants who have schizophrenia. For each item, symptom severity was rated on a 4-point scale, from 0=absent to 3=severe, with a total scoring range of 0 to 27. Higher scores indicated more impairment. A negative change from baseline indicated an improvement in symptoms.|Baseline and Week 12|All randomized participants who received either MK-8435 (Org 25935) or placebo and who completed at least 8 weeks of treatment.||Score on a Scale||Standard Deviation|Mean
772373|NCT00725075|Secondary|Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) for Schizophrenia at Week 12|PANSS was a 30-item clinician-rated instrument used for assessing the positive, negative, and general psychopathology symptoms of schizophrenia. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme, with a total scoring range of 30 to 210. Higher scores indicated more impairment. A negative change from baseline indicated an improvement in symptoms.|Baseline and Week 12|All randomized participants who received either MK-8435 (Org 25935) or placebo and who completed at least 8 weeks of treatment.||Score on a Scale||Standard Deviation|Mean
772374|NCT00725075|Primary|Change From Baseline in Modified Scale for the Assessment of Negative Symptoms (SANS 1-22 Composite Score) at Week 12|SANS was a 25-item clinician-rated instrument for assessing the negative symptoms of schizophrenia. SANS 1-22 Composite Score consisted of the SANS 25 scale minus the last 3 questions (attention items). The remaining non-attention items (affective flattening, alogia, avolition-apathy, and anhedonia-asociality) comprised the SANS 1-22 Composite Score. For each item, symptom severity was rated on a 6-point scale, from 0=absent to 5=severe. The SANS 1-22 Composite Score had a total scoring range of 0 to 110. Higher scores indicated more impairment. The SANS 1-22 Composite Score was reported using data from the adjusted site rater. A negative change from baseline indicated an improvement in symptoms.|Baseline and Week 12|All randomized participants who received either MK-8435 (Org 25935) or placebo and who completed at least 8 weeks of treatment.||Score on a Scale||Standard Deviation|Mean
772375|NCT00725101|Secondary|Number of Days Fibromyalgia (FM) Affected Participant Productivity (Missed Work)|Participant productivity was described as the number of days a participant missed work due to FM.|Baseline through 12 months|The analysis population included enrolled participants who had at least 1 follow-up visit.||days||Standard Deviation|Mean
772376|NCT00725101|Secondary|Number of Days Fibromyalgia (FM) Affected Participant Productivity (Stayed in Bed, Reduced Activity, and Received Disability Income)|Participant productivity was described as the number of days the participant stayed in bed, had to reduce normal activity by half, and received disability income due to FM.|Baseline through 12 months|The analysis population included enrolled participants who had at least 1 follow-up visit.||days||Standard Deviation|Mean
772377|NCT00725101|Secondary|Number of Days of Caregiver Burden Due to Fibromyalgia (FM; Family Used an Unpaid Caregiver)|Caregiver burden was described as the number of days family members used an unpaid caregiver (family and friends) to care for the participant with FM.|Baseline through 12 months|The analysis population included enrolled participants who had at least 1 follow-up visit.||days||Standard Deviation|Mean
772378|NCT00725101|Secondary|Number of Days of Caregiver Burden Due to Fibromyalgia (FM; Family Missed Paid Work and Used a Paid Caregiver)|Caregiver burden was described as the number of days family members missed paid work and used a paid caregiver (for example, home healthcare nurse) to care for the participant with FM.|Baseline through 12 months|The analysis population included enrolled participants who had at least 1 follow-up visit.||days||Standard Deviation|Mean
772379|NCT00725101|Secondary|Number of Days of Partial Care for Fibromyalgia (FM) Participants|Partial (day or night) care included day care, day nursing home, and partial hospitalization.|Baseline through 12 months|The analysis population included enrolled participants who had at least 1 follow-up visit.||days||Standard Deviation|Mean
772380|NCT00725101|Secondary|Number of Emergency Room (ER) Visits Due to Fibromyalgia (FM)||Baseline through 12 months|The analysis population included enrolled participants who had at least 1 follow-up visit. The number of participants actually used in analyses were less than 1700 because some had missing ER visit values.||ER visits||Standard Deviation|Mean
772381|NCT00725101|Secondary|Number of Outpatient Visits Due to Fibromyalgia (FM)||Baseline through 12 months|The analysis population included enrolled participants who had at least 1 follow-up visit. The number of participants actually used in analyses were less than 1700 because some had missing outpatient visit values.||outpatient visits||Standard Deviation|Mean
772382|NCT00725101|Secondary|Change From Baseline in Sheehan Disability Score (SDS) Total Score at 12 Months|The SDS is completed by the participant and assesses the effect of the participant's symptoms on work/social/family life. Total scores range from 0 to 30; Higher score=greater disruption in the participant's work/social/family life.|Baseline, 12 months|The analysis population included enrolled participants who had non-missing SDS scores at Baseline and 12 months.||units on a scale||Standard Deviation|Mean
772383|NCT00725101|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score at 12 Months|FIQ measures self-reported fibromyalgia (FM) status, progress, and outcomes over past week. FIQ comprises 20 items: Items 1-11 measure physical functioning (each rated on 4-point Likert-type scale); Items 12 + 13 measure number (no.) of days participant felt well and no. of days participant felt unable to work due to FM symptoms. Items 14-20 are numerical, 11-point Likert-type scales (marked in 10-millimeter [mm] increments) rating work difficulty, pain intensity, fatigue, morning tiredness, stiffness, anxiety, and depression. Total scores range from 0-80; Higher score=greater negative impact.|Baseline, 12 months|The analysis population included enrolled participants who had non-missing FIQ scores at Baseline and 12 months.||units on a scale||Standard Deviation|Mean
772384|NCT00725101|Secondary|Change From Baseline in Brief Pain Inventory-Severity (BPI-S) Average Subscale Score at 12 Months|BPI-S measures self-reported severity of pain. Severity scores range from 0 (no pain) to 10 (severe pain) for each question assessing worst pain, least pain, and average pain in past 24 hours, and current pain.|Baseline, 12 months|The analysis population included participants who had non-missing BPI-S scores at Baseline and 12 months.||units on a scale||Standard Deviation|Mean
772397|NCT00725270|Primary|Change in Positive Psychotic Symptoms Over the Course of Treatment|Utilized the Positive Symptoms Subscale of the Brief Psychiatric Rating Scale is assess psychotic symptoms. Range for the subscale is 4-28, with 4 = no positive symptoms|8 days|||units on a scale||Standard Deviation|Mean
786181|NCT00833690|Secondary|Serum Urate|From blood sample drawn after taking study drug that day|Visit 11 (Month 21; 630 +/- 7 days after Baseline Visit)|||mg/dL||Standard Deviation|Mean
772385|NCT00725101|Secondary|Change From Baseline in Brief Pain Inventory-Interference (BPI-I) Average Subscale Score at 12 Months|Average BPI-I measures self-reported degree of pain interference on function. Interference scores range from 0 (does not interfere) to 10 (completely interferes) for each question assessing interference of pain within past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items.|Baseline, 12 months|The analysis population included participants who had non-missing BPI-I scores at Baseline and 12 months.||units on a scale||Standard Deviation|Mean
772386|NCT00725101|Secondary|Hazard Ratios for Factors Associated With Discontinued Opioid Use|Factors significantly associated with discontinuation of opioid use were participant age, Brief Pain Inventory-Interference (BPI-I) score, and Patient Health Questionnaire for somatic symptoms (PHQ-15) score.|Baseline through 12 months|The analysis population included participants who were using opioids at Baseline.||hazard ratio|||Number
772387|NCT00725101|Secondary|Percentage of Participants Who Discontinued Opioids||Baseline through 12 months|The analysis population included participants who were using opioids at Baseline.||percentage of participants|||Number
772388|NCT00725101|Secondary|Reasons for Discontinuing Medications for Fibromyalgia (FM) During the Study|Participants were allowed to select multiple reasons for discontinuing treatment. During the 12-month period post-baseline, a participant could possibly discontinue more than 1 medication, or discontinue the same medication more than once. A reason for discontinuation was given each time a participant stopped taking a medication.|Baseline through 12 months|The analysis population included participants who reported discontinuing medication at least once during the 12-month period post-baseline.||participants|||Number
772389|NCT00725101|Primary|Odds Ratios From Stepwise Logistic Regression Model of Longitudinal Adherence to Duloxetine Treatment for Fibromyalgia (FM) Over 12 Months: Generalized Anxiety Disorder-7 (GAD-7) Score, Pregabalin Use, and Non-Steroidal Anti-Inflammatory Drug (NSAID) Use|Significant variables included in the final model were pregabalin use, NSAID use, and GAD-7 (7-item, self-reported measurement of GAD severity [not at all severe, severe for several days, severe for more than half the days, severe nearly every day]; Total score=sum of all 7 items; ranges from 0 to 21; Higher score=greater level of anxiety). Odds ratios were based on medication possession ratio (MPR) ≥0.8 for pregabalin and NSAID use among duloxetine initiators at Baseline; MPR=total supply days/total number of days in 12-month study period.|Baseline through 12 months|The analysis population included enrolled participants who had non-missing covariates used in logistic regression.||odds ratio||95% Confidence Interval|Number
772390|NCT00725101|Primary|Odds Ratio From Stepwise Logistic Regression Model of Baseline Medication Use for Fibromyalgia (FM): Duloxetine, Pregabalin, or Milnacipran Versus Any Other Medication|Significant variables included in the final model were age over 65, physician gender and specialty, use of opioids (excluding tramadol), use of non-steroidal anti-inflammatory drugs (NSAIDs), and number of medications.|Baseline through 12 months|The analysis population included enrolled participants who had non-missing covariates used in logistic regression.||odds ratio||95% Confidence Interval|Number
772391|NCT00725101|Primary|Cumulative Number of Medications Taken for Fibromyalgia (FM) Over 12 Months||Baseline through 12 months|The analysis population included enrolled participants who took part in all follow-up interviews.||medications||Standard Deviation|Mean
772392|NCT00725153|Primary|Front Surface Lens Deposits|Film and discrete deposits were assessed with a slit-lamp after 10 hours of lens wear. Film deposits were recorded on a 5-point scale, where 0=no deposition, clean surface; 1=slight, deposition occupying 1-5% of lens front surface; 2=mild, deposition occupying 6-15% of lens front surface; 3=moderate, deposition occupying 16-25% of lens front surface; 4=severe, deposition occupying >25% of lens front surface. Discrete deposits were recorded on a 5-point scale, where 0=no deposition, clean surface; 1=microdeposits (less than or equal to 10 dots); 2=microdeposits (greater than 10 dots); 3=macro deposits; 4=one or more jelly bumps. Participants were classified into Front Surface Lens Deposits <2 (less than grade 2 for both film and discrete) and into front surface lens deposits >1 (greater than grade 1 for either film, discrete, or both).|10 hours|All enrolled participants.||Participants|||Number
772393|NCT00725205|Secondary|Number Of Participants Self-Administering Pegylated Interferon Alfa-2b|Number of participants self-administering Pegylated interferon alfa-2b injection pen. If a participant changed the way he or she administered the injection pen during the course of the study (from self-administering to clinic-administering or the other way around), that participant was also considered as self-administering.|Up to 48 Weeks|All Participants enrolled.||Participants|||Number
772394|NCT00725205|Secondary|Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up|Sustained virologic response (SVR) was assessed at post-treatment Follow-up Week 24. Day 1 of the Follow-up period was defined as the first day after the last dose day. A participant was considered a sustained responder if the participant had undetectable Hepatitis C virus Ribonucleic acid (HCV-RNA) level (based on qualitative test result) at Follow-up Week 24. If a participant with missing polymerase chain reaction (PCR) data at Follow-up Week 24 had undetectable HCV-RNA level at Follow-up Week 12, the participant was also considered as a sustained responder.|24 Weeks following completion of 24 or 48 weeks of therapy|Full Analyses Set: All enrolled participants who received any dose of any medication (Peginterferon or Ribavirin) and had a known viral genotype. Of the 294 enrolled participants, 2 were not treated.||Participants|||Number
772395|NCT00725205|Primary|Number of Participants Who Are Triple-80 Compliant|Participants who continued treatment beyond Week 12 (i.e., 24 or 48 weeks depending on the viral genotype) were assessed for triple-80 compliance. Triple-80 compliant, or simply compliant, participants were those that received >= 80% of the planned total doses of both pegylated interferon alfa-2b and ribavirin for >=80% of the duration of the therapy. 3 rates were computed: Compliance with study duration, compliance with pegylated interferon dose, and compliance with ribavirin dose. A participant was defined as triple-80 compliant, if none of the 3 rates as defined above were less than 80.|24 or 48 Weeks|"All enrolled participants who received any dose of any medication, had a known viral genotype, and did not discontinue from the study with the status being “treatment
failure”. Of the 294 enrolled participants, 253 participants started treatment and continued treatment beyond Week 12."||Participants|||Number
772396|NCT00725270|Primary|Change in Mood Symptoms|Utilized the Hamilton Depression Rating Scale, 21-item version to assess depressive symptoms, with a range of 0-63, with higher scores indicating greater levels of depression.|Baseline and Day 9|||units on a scale||Standard Deviation|Mean
772400|NCT00725296|Primary|Median Dose During Induction Therapy and Subsequent Maintenance Therapy|The median dose per infusion measured in mg/kg in participants receiving induction therapy and subsequent maintenance therapy (Infusions 1-3 were induction therapy and infusions 4-9 were maintenance therapy for a total of 9 consecutive infusions).|Up to 24 Months|"N= number of Infliximab-naive participants that received induction & maintenance therapy.
Out of 152 Infliximab-naive participants who were treated, 94 participants received induction therapy (Infliximab at weeks 0, 2, and 6), 83 participants received induction therapy and subsequent maintenance therapy (maximum of 6 maintenance infusions)."||mg/kg||Full Range|Median
772401|NCT00725296|Primary|Average Dose During Induction Therapy and Subsequent Maintenance Therapy|The average dose per infusion measured in milligrams/killogram (mg/kg) in participants receiving induction therapy and subsequent maintenance therapy (Infusions 1-3 were induction therapy and infusions 4-9 were maintenance therapy for a total of 9 consecutive infusions).|Up to 24 Months|"N= number of Infliximab-naive participants that received induction & maintenance therapy.
Out of 152 Infliximab-naive participants who were treated, 94 participants received induction therapy (Infliximab at weeks 0, 2, and 6), 83 participants received induction therapy and subsequent maintenance therapy (maximum of 6 maintenance infusions)."||mg/kg||Standard Deviation|Mean
772402|NCT00725296|Primary|Median Time Interval Between Infusions During Maintenance Therapy|The median time interval measured in days between Infliximab infusions in participants during the maintenance therapy (between infusion 3/4, 4/5, 5/6, 6/7, 7/8, 8/9) following induction therapy.|Up to 24 months|"N= number of Infliximab-naive participants that received induction & maintenance therapy.
Out of 152 Infliximab-naive participants who were treated, 94 participants received induction therapy (Infliximab at weeks 0, 2, and 6), 83 participants received induction therapy and subsequent maintenance therapy (maximum of 6 maintenance infusions)."||days||Full Range|Median
772403|NCT00725296|Primary|Mean Time Interval Between Infusions During Maintenance Therapy|The mean time interval measured in days between Infliximab infusions in participants during the maintenance therapy (between infusion 3/4, 4/5, 5/6, 6/7, 7/8, 8/9) following induction therapy.|Up to 24 months|"N= number of Infliximab-naive participants that received induction & maintenance therapy.
Out of 152 Infliximab-naive participants who were treated, 94 participants received induction therapy (Infliximab at weeks 0, 2, and 6), 83 participants received induction therapy and subsequent maintenance therapy (maximum of 6 maintenance infusions)."||days||Standard Deviation|Mean
772404|NCT00725361|Secondary|Change in the Scleroderma Health Assessment Questionnaire (SHAQ) at Week 24 Compared With Baseline.|Range is 0-3 with 0 meaning the least amount of disability and 3 the greatest of disability.|24 weeks|||units on a scale||Standard Deviation|Mean
772405|NCT00725361|Secondary|Subjects Experiencing Complete Healing of > 50% of the Number of Baseline DU at Week 12.||12 weeks|At 12 weeks only 1 patient had withdrawn from the study and 19 remained in the study.||Participants|||Count of Participants
772406|NCT00725361|Secondary|Subjects Experiencing Complete (Total Reepithelialization) Healing of All Baseline DU at Week 12.||12 weeks|At 12 weeks only 1 patient had withdrawn from the study and 19 remained in the study.||Participants|||Count of Participants
772407|NCT00725361|Secondary|New DU 4 Weeks Prior to Week 12|The number of new DU that have developed in the preceding 4 weeks assessed at week 12 from baseline.|4 weeks prior to week 12|At 12 weeks only 1 patient had withdrawn from the study and 19 remained in the study.||new digital ulcers||Standard Deviation|Mean
772408|NCT00725361|Primary|New Digital Ulcers (DU) 4 Weeks Prior to Week 24|The number of new digital ulcers (DU) that have developed in the preceding 4 weeks assessed at week 24 from baseline.|4 weeks prior to week 24|||new digital ulcers||Standard Deviation|Mean
772409|NCT00725452|Secondary|Mean Percent Change From Baseline in Body Surface Area (BSA) Involved With Psoriasis After Treatment With Infliximab|BSA estimation was determined using the participant's handprint (palmar surface of palms plus five digits). The number of handprints that covered the affected skin area was counted. One handprint was approximately equivalent to 1 percent of the BSA; therefore, BSA was calculated in percentages. The change from Baseline in BSA was calculated by subtracting Baseline from infusion 9.|Baseline and Infusion 9|Infliximab-naive participants who received Infliximab during the study.||Percent of BSA involved with psoriasis||Standard Deviation|Mean
772410|NCT00725452|Secondary|Median Dose of Infliximab||Maximum 2 years|All participants who received at least 1 Infliximab infusion during the observational phase.||mg/kg||Full Range|Median
772411|NCT00725452|Secondary|Mean Dose of Infliximab||Maximum 2 years|All participants who received at least 1 Infliximab infusion during the observational phase.||milligrams/kilograms (mg/kg)||Standard Deviation|Mean
772412|NCT00725452|Secondary|Median Time Interval Between Infliximab Infusions During Maintenance Treatment Following Induction Therapy||Maximum 2 years|Infliximab-naive participants who received induction therapy and subsequent maintenance therapy with Infliximab.||Days||Full Range|Mean
772413|NCT00725452|Secondary|Mean Time Interval Between Infliximab Infusions During Maintenance Treatment Following Induction Therapy||Maximum 2 years|Infliximab-naive participants who received induction therapy and subsequent maintenance therapy with Infliximab.||Days||Standard Deviation|Mean
772414|NCT00725452|Primary|Number of Therapies That Were Applied as Induction, Maintenance, or Episodic Therapies After One Infusion of Infliximab|"The types of therapies were assessed according to the following criteria:
Induction therapy: first infusion given at Week 0 (Baseline). Second infusion given at Week 2 (+/- 7 days). Third infusion given at Week 6 (+/- 7 days).
Maintenance therapy: given in approximately 8-week (56-day) intervals (time window +4 weeks to -2 weeks). One infusion given out of the time window was accepted to be classified as maintenance therapy, if the remaining infusions were given within the time window (8 weeks, +4 to -2 weeks).
Episodic Therapy: given out of time frame (> 12 weeks)."|Maximum 2 years|Infliximab-naive participants who received Infliximab during the study.||Therapies|||Number
772415|NCT00725491|Primary|The Amount of International Units (IU) of Recombinant Follicle Stimulating Hormone (recFSH) Needed in a Controlled Ovarian Stimulation (COS) Cycle up to the First Day the Human Chorionic Gonadotropin (hCG) Criterion is Met.|The hCG criterion is met the first day that 3 follicles >= 17 mm are observed.|At completion of ovarian stimulation; maximally after 18 days of recFSH administration.|The number of participants for this analysis included only those participants in the intent-to-treat (ITT) group who received hCG and for whom data was available.||international units (IU)||Standard Deviation|Mean
786182|NCT00833690|Secondary|Serum Urate|From blood sample drawn after taking study drug that day|Visit 10 (Month 18; 540 +/- 7 days after Baseline Visit)|||mg/dL||Standard Deviation|Mean
772417|NCT00725530|Primary|Front Surface Lens Deposits|Film and discrete deposits were assessed with a slit-lamp after 2-5 hours of open eye lens wear. Film deposits were recorded on a 5-point scale, where 0=no deposition, clean surface; 1=slight, deposition occupying 1-5% of lens front surface; 2=mild, deposition occupying 6-15% of lens front surface; 3=moderate, deposition occupying 16-25% of lens front surface; 4=severe, deposition occupying >25% of lens front surface. Discrete deposits were recorded on a 5-point scale, where 0=no deposition, clean surface; 1=microdeposits (less than or equal to 10 dots); 2=microdeposits (greater than 10 dots); 3=macro deposits; 4=one or more jelly bumps. Participants were classified into Front Surface Lens Deposits <2 (less than grade 2 for both film and discrete) and into front surface lens deposits >1 (greater than grade 1 for either film, discrete, or both).|7 days|All enrolled participants.||Participants|||Number
772418|NCT00725543|Primary|Median Remicade Dose Per Participant||Maximum of 24 months|Remicade-naive participants who were exposed to Remicade during the observational study.||mg/kg||Full Range|Median
772419|NCT00725543|Primary|Mean Remicade Dose Per Participant||Maximum of 24 months|Remicade-naive participants who were exposed to Remicade during the observational study.||mg/kg||Standard Deviation|Mean
772420|NCT00725543|Primary|Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy||Maximum of 24 months.|Remicade-naive participants who received Remicade induction therapy and subsequent maintenance therapy during the observational study.||mg/kg||Full Range|Median
772421|NCT00725543|Primary|Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy||Maximum of 24 months.|Remicade-naive participants who received Remicade induction therapy and subsequent maintenance therapy during the observational study.||milligrams/kilograms (mg/kg)||Standard Deviation|Mean
772422|NCT00725543|Primary|Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy||Maximum of 24 months|Remicade-naive participants who received Remicade induction therapy and subsequent maintenance therapy during the observational study.||Days||Full Range|Median
772423|NCT00725543|Primary|Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy||Maximum of 24 months|Remicade-naive participants who received Remicade induction therapy and subsequent maintenance therapy during the observational study.||Days||Standard Deviation|Mean
772424|NCT00725608|Secondary|Dispensing of Suboxone (Buprenorphine Plus Naloxone)|Another of the secondary objectives was to evaluate the effect of the switch to Suboxone (buprenorphine plus naloxone) on medication dispensing measured by frequency of visits to the treating physician or pharmacy to receive the medication (daily, biweekly, once weekly, monthly, other)|month 6, month 12|All participants with eligible datasets were included in the final analysis||Participants|||Number
772425|NCT00725608|Secondary|Dosing of Suboxone (Buprenorphine Plus Naloxone)|One of the secondary objectives was to evaluate the effect of the switch to buprenorphine/naloxone on medication dispensing measured by dose.|day 1, month 6, month 12|All participants with eligible datasets were included in the final analysis||Dose of Suboxone® in mg||Standard Deviation|Mean
772426|NCT00725608|Primary|Retention Rate|The primary objective of this study was to determine the retention rate of patients after 6 and 12 months of treatment with buprenorphine/naloxone measured by the percentage of patients remaining in the study|month 6, month 12|All eligible datasets were included in analysis population.||percentage of patients||95% Confidence Interval|Number
772427|NCT00725621|Secondary|Impact of Remicade Location (Specialized Hospitals Versus Extramural Infusion Centers) on the MCS|Participant's quality of life was measured by the short-form 36 (SF-36). The SF-36 is a survey with 36 questions. It is composed of the PCS & the MCS. The SF-36 consisted of eight scaled scores, which were the weighted sums of the questions in their section. Each scale was directly transformed into a 0 (lowest level of functioning) - 100 (highest level of functioning) scale on the assumption that each question carried equal weight. The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.|24 months maximum|Remicade-naive participants with available data.||Score on a scale||Standard Deviation|Mean
772428|NCT00725621|Secondary|Impact of Remicade Location (Specialized Hospitals Versus Extramural Infusion Centers) on the Physical Component Summary Score (PCS)|Participant's quality of life was measured by the short-form 36 (SF-36). The SF-36 is a survey with 36 questions. It is composed of the PCS & the Mental Component Summary Score (MCS). The SF-36 consisted of eight scaled scores, which were the weighted sums of the questions in their section. Each scale was directly transformed into a 0 (lowest level of functioning) - 100 (highest level of functioning) scale on the assumption that each question carried equal weight. The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.|24 months maximum|Remicade-naive participants with available data.||Score on a scale||Standard Deviation|Mean
772429|NCT00725621|Primary|Median Remicade Dose Per Participant||Maximum of 102 weeks|Remicade-naive participants who were exposed to Remicade during the observational study.||mg/kg||Full Range|Median
772430|NCT00725621|Primary|Mean Remicade Dose Per Participant||Maximum of 102 weeks|Remicade-naive participants who were exposed to Remicade during the observational study.||mg/kg||Standard Deviation|Mean
772431|NCT00725621|Primary|Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy|The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.|Maximum of 102 weeks|Remicade-naive participants who received Remicade induction therapy and subsequent maintenance therapy during the observational study.||mg/kg||Full Range|Median
772432|NCT00725621|Secondary|Number and Kind of Previous Therapies With Disease-Modifying Anti-Rheumatic Drugs (DMARDs)|Some participants had more than one previous treatment with a DMARD.|24 months maximum|Remicade-naive participants who were exposed to Remicade during the observational study.||Participants|||Number
772433|NCT00725621|Secondary|Disease Progression Specified by the Time Period Between Onset of Rheumatoid Arthritis (RA) and Onset of Remicade Therapy||24 months maximum|Remicade-naive participants who were exposed to Remicade during the observational study.||Years||Standard Deviation|Mean
772434|NCT00725621|Primary|Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy|The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.|Maximum of 102 weeks|Remicade-naive participants who received Remicade induction therapy and subsequent maintenance therapy during the observational study.||milligrams/kilograms (mg/kg)||Standard Deviation|Mean
772436|NCT00725621|Primary|Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy|The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.|Maximum of 16 weeks|Remicade-naive participants who received Remicade induction therapy and subsequent maintenance therapy during the observational study.||Days||Standard Deviation|Mean
772437|NCT00725712|Secondary|Median Duration of Overall Survival (OS)of GSK1363089|Duration of OS is defined as (Date of Death [due to any cause]) minus Date of first dose. For the participants who were alive at the time of data cut-off, duration of overall survival was censored at the date of last contact. The upper value of the full range was censored observation.|At every 8 Weeks upto 31 months|Evaluable population||months||Full Range|Median
772438|NCT00725712|Secondary|Disease Stabilization Rate of GSK 1363089|It is defined as the number of participants achieving best overall response of confirmed CR or PR or stable disease (SD). It was assessed using RECIST criteria 1.0. The CR for target lesions was defined as disappearance of all TLs and the NTLs. PR is at least 30% decrease in sum of the LD of TLs, taking as reference baseline sum LD. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as a reference, the smallest sum LD since the treatment started.|At every 8 Weeks upto 31 months|Safety population||percentage of participants||95% Confidence Interval|Number
772439|NCT00725712|Secondary|Duration of Stable Disease of GSK1363089|Duration of stable disease, was defined as the time between the date of first dose and death or disease progression, in participants whose best overall response was not progressive disease|At every 8 Weeks upto 31 months|Evaluable population. Only those participants available at the specified time-points were analyzed.||months||95% Confidence Interval|Median
772440|NCT00725712|Secondary|Median Progression Free Survival (PFS) of GSK1363089|Duration of PFS in months is defined as (Date of Disease Progression/Death - Date of First Dose + 1)/30.44. For participants who did not reach an event (disease progression or death) at the time of data cut-off, duration of PFS is censored at date of last available tumor assessment that is not 'Unable to Evaluate'. For participants who did not have any post-baseline tumor assessments, PFS was censored at Day 1. For any participants who received subsequent anti-cancer therapy, PFS will be right censored at the date of last adequate tumor assessment on or prior to the date of anti-cancer therapy initiation. For any participants who died or progressed after an extended lost-to-follow-up time (greater than 17 weeks), PFS was censored at the date of last adequate assessment prior to extended lost-to follow-up.|At every 8 Weeks upto 31 months|Safety population||months||95% Confidence Interval|Median
772441|NCT00725712|Primary|Number of Participants Who Required Concomitant Medications|The number of participants who received concomitant medication during the study were reported. The data has been reported for the participants who have received subsequent chemotherapy, subsequent radiation therapy or other therapy.|Baseline (pre-dose) and before 30-day follow- up (up to 2 years)|Safety population.||Participants|||Count of Participants
772442|NCT00725712|Primary|Number of Participants With Shift From Baseline by Grade for Hematology Parameters|The worst overall grading by CTCAE version 3.0, was used to report the shift from baseline for hematology parameters namely hemoglobin, platelets and lymphocytes. The grades were namely G0, G1, G2, G3 and G4. The data for shifts from G2 to G3 and G0 to G4, mainly the shifts to higher grades G3 and G4 have been reported.|Baseline (pre-dose) and before 30-day follow- up (up to 2 years)|Safety population. Only those participants available at the specified time points were analyzed.||Participants|||Count of Participants
772443|NCT00725712|Primary|Number of Participants With Grade Shift for Urinalysis Parameters|The urinalysis parameters by worst case overall CTCAE grade shift post Baseline for each parameter were mentioned as per the CTCAE grading for version 3.0 and done as per intensity namely mild moderate severe life-threatening or Death. Participants were analyzed for abnormal values for bilirubin, ketones, nitrites, occult blood, pH, protein, specific gravity, and urobilinogen.|From Day 1 and before 30-day follow- up (up to 2 years)|Safety population. Only those participants available at the specified timepoints were reported.||participants|||Number
772444|NCT00725712|Primary|Number of Participants With Shift From Baseline by High/Low Flag for Hematology Paramaters|The hematology parameters worst case overall CTCAE grade shift post Baseline for each parameter was mentioned. CTCAE grading for version 3.0 was used and done as per intensity namely mild moderate severe life-threatening or Death. Participants were analyzed for basophils, eosinophils, erythrocytes, hematocrit, and monocytes were analyzed. Only the abnormal values were reported where normal to high and normal to low changes were reported. Worst Overall was defined as highest post baseline CTCAE grade before 30 day follow up.|From Day 1 and before 30-day follow- up (up to 2 years)|Safety population. Only those participants available at the specified time points were analyzed.||participants|||Number
772445|NCT00725712|Primary|Number of Participants With Shift From Baseline in Serum Chemistry- Graded|The worst overall common terminology criteria for adverse events version 3.0 (CTCAE) grade (G) shift post baseline for each parameter was mentioned. Only worst case scenarios are presented. CTCAE grading is done as per intensity namely mild moderate severe life-threatening or Death. Analysis was done for Alanine aminotransferases, aspartate aminotransferases, Albumin, alkaline phosphatase, calcium, sodium, potassium, glucose, amylase, amylase, bilirubin, creatinine, phosphate, gamma glutamyl transferases (GGT), and triglycerol lipase. Worst Overall defined as worst post baseline out of normal range flag in the order of (high, low, normal) before 30 day follow up. Data for G3 and G4 is reported.|From Day 1 to up to 30-day follow-up visit (up to 2 years)|Safety population. Only those participants available at the specified time points were analyzed .||Participants|||Count of Participants
772446|NCT00725712|Primary|Number of Participants With Shift From Baseline in by High/Low Flag for Serum Chemistry- Ungraded|The data for serum chemistry parameters like albumin, alanine aminotransferase (ALT), alkaline phosphatase (ALP), amylase, aspartate amino transferase (AST), calcium, carbon dioxide, creatinine, gamma glutamyl transferase (GGT), glucose, blood urea nitrogen (BUN), chloride, free thyroxine, free triiodothyronine, lipase, phosphorous, potassium, sodium, total bilirubin, lactate dehydrogenase, total protein. The abnormal values have been reported wherein data for normal to low and normal to high has been reported.|From Day 1 and before 30-day follow- up (up to 2 years)|Safety population. Only those participants available at the specified time points we re analyzed.||participants|||Number
772808|NCT00734162|Secondary|Change From Baseline in Z-score for Spine BMD at Week 96|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 96|Participants in the Safety Analysis Set with available data were analyzed.||z-score||Standard Deviation|Mean
772447|NCT00725712|Primary|Change From Baseline in Respiratory Rate (RR)|The RR for the participant’s, were collected after the participant sat quietly for at least five minutes. Baseline evaluations should be performed within 72 hours before the first dose. If performed within 24 hours of the first dose, baseline evaluations may serve as the pre-dose Day 1 visit evaluations. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. Baseline was defined as pre-dose, Day 1 . The RR was measured in breaths per minute. Min and max post-baseline values are reported.|Baseline (pre-dose, Day 1) and before 30-day follow- up (up to 2 years)|Safety population. Only those participants available at the specified time-points were analyzed.||breaths per minute||Standard Deviation|Mean
772448|NCT00725712|Primary|Change From Baseline in Temperature|The body temperature for the participants was assessed. These were collected after the participant sat quietly for at least five minutes. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline is defined as the last non-missing record on or before first dose.|Baseline (pre-dose, Day 1) and before 30-day follow- up (up to 2 years)|Safety population. Only those participants available at the specified time points were analyzed.||degree celsius||Standard Deviation|Mean
772449|NCT00725712|Primary|Change From Baseline in Vital Signs-Pulse Rate|The pulse rate or heart rate (HR) for the participant’s, were collected after the participant sat quietly for at least five minutes. Baseline evaluations were performed within 72 hours before the first dose. If performed within 24 hours of the first dose, baseline evaluations may serve as the pre-dose Day 1 visit evaluations. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline was defined as pre-dose, Day 1. The HR was measured in beats per minute (bpm). The min and max values have been reported.|Baseline (pre-dose, Day 1) and before 30-day follow- up (up to 2 years)|Safety population. Only those participants available at the specified time points were analyzed.||beats per minute||Standard Deviation|Mean
772450|NCT00725712|Primary|Change From Baseline in Vital Signs-Systolic and Diastolic Blood Pressure|Participants systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured in mm of mercury (mmHg). These were collected after the participant sat quietly for at least five minutes. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. The data for minimum (min) and maximum (max) post-baseline has been reported. Baseline is defined as the last non-missing record on or before first dose.|Baseline (pre-dose, Day 1) and before 30-day follow- up (up to 2 years)|Safety population. Only those participants available at the specified time points were analyzed.||mmHg||Standard Deviation|Mean
772451|NCT00725712|Primary|Number of Participants With Adverse Event (AE) and Serious Adverse Event (SAE)|An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product whether or not it is considered drug related. This would include any side effect, injury, toxicity, sensitivity reaction, abnormal or worsening of a laboratory value, concurrent illness or sudden death. Pre-existing conditions that worsen during a study will be reported as AEs. SAE is an AE that results in death, is life-threatening, requires inpatient hospitalization or extends a current hospital stay, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect. Medical events that do not result in death, are not life-threatening, or do not require hospitalization may be considered SAEs if they put the participant in danger or require medical or surgical intervention to prevent one of the results listed above.|Up to 31 months|Safety population included all participants who passed the screening criteria, enrolled in the study, and received at least 1 dose of study drug.||participants|||Number
772452|NCT00725712|Primary|Number of Participants With Objective Response Rate (ORR), of GSK1363089, Per- Response Evaluation Criteria in Solid Tumors (RECIST) Criteria Version 1.0|ORR is defined as the percentage of participants achieving best overall response of confirmed complete response (CR) or partial response (PR). Tumor response for participants with measurable lesions was assessed routinely (after 8 weeks of treatment and approximately every 8 weeks thereafter) using RECIST (version 1.0) criteria. The CR for target lesions was defined as disappearance of all target lesions (TLs) and the non-target lesions (NTLs). PR defined as at least 30% decrease in sum of the longest diameter (LD) of TLs, taking as reference baseline sum LD. The safety population included all participants who passed the screening criteria, enrolled in the study, and received at least 1 dose of study drug. Progressive disease will be used as PD.|At every 8 Weeks upto 31 months|Evaluable population included participants from safety population who had received atleast 75% of protocol mandated doses at treatment period, had BL and post BL tumor assessment, with no extended lost to followup (17 wks or more) or who had received atleast 75% of protocol mandated doses at treatment period and discontinued study drug due to PD.||participants|||Number
772453|NCT00725725|Secondary|Number of Participants Discontinuing Study Therapy Due to AEs|The number of participants withdrawing from study treatment during the treatment period was determined. An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 2 weeks|All treated participants are included in the safety analysis.||Participants|||Number
772454|NCT00725725|Secondary|Number of Participants Experiencing an Adverse Event (AE)|The number of participants experiencing one or more AEs throughout the study period was determined. An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 59 days|All treated participants are included in the safety analysis.||Participants|||Number
772455|NCT00725725|Secondary|Change in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Score|"The mean change in Q-LES-Q score from baseline (Screening) to EOT (Day 36) was calculated for each arm. The Q-LES-Q is a self-report questionnaire rating 16 aspects of quality of life, including physical health and mood. Scores range from 0 (very poor) to 5 (very good), with total score ranging from 0 to 80 (higher O-LES-Q scores indicate greater quality of life)."|Screening and Day 36|The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and had Q-LES-Q scores at Screening and EOT.||Q-LES-Q Score||Standard Deviation|Mean
772467|NCT00725751|Primary|Number of Participants Who Completed Treatment With PegIFN-2b/Ribavirin|For participants with Genotype 1 or 4 completion of treatment was at Week 48; for participants with Genotype 2, 3, or 1 with low viral load or rapid virologic response, completion of therapy was at Week 24.|24 to 48 weeks|Participants who received at least one dose of PegIFN-2b/ribavirin||participants|||Number
772456|NCT00725725|Secondary|Change in Montgomery-Asberg Rating Scale for Depression (MADRS) Score|The mean change in MADRS score from baseline (Screening) to EOT (Day 36) was calculated for each arm. The MADRS is a 10-item clinical-administered scale designed to assess severity of depression. Each item is rated from 0 to 6, with total score ranging from 0 to 60 (higher MADRS scores indicate more severe depression).|Screening and Day 36|The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and had MADRS scores at Screening and EOT.||MADRS score||Standard Deviation|Mean
772457|NCT00725725|Secondary|Change in Anxiety Sensitivity Index (ASI) Score|The mean change in ASI score from baseline (Screening) to EOT (Day 36) was calculated for each arm. The ASI is a 16-item self-report questionnaire that assesses fear of anxiety sensations. Each item is scored on a 5-point Likert scale (0 to 4) with total score ranging from a minimum of 0 to a maximum of 64 (higher scores indicate greater fear of anxiety sensations).|Screening and Day 36|The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and had ASI scores at Screening and EOT.||ASI Score||Standard Deviation|Mean
772458|NCT00725725|Secondary|Change in Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A) Score|The mean change in SIGH-A score from baseline (Screening) to EOT (Day 36) was calculated for each arm. The SIGH-A is a 14-item scale to assess anxiety in a clinical population. Each item is scored on a 5-point Likert scale (0 to 4) with the total score ranging from a minimum of zero to a maximum of 56 (higher scores indicate greater anxiety severity).|Screening and Day 36|The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and had SIGH-A scores at Screening and EOT.||SIGH-A Score||Standard Deviation|Mean
772459|NCT00725725|Secondary|Change in Clinical Global Impression-Severity (CGI-S) Score|The mean change in CGI-S score from baseline (Screening) to EOT (Day 36) was calculated for each arm. The CGI-S is a clinician-rated instrument used to assess global severity of general anxiety symptoms. The instrument consists of a 7-point scale that the clinician uses to rate the severity of the patient's illness, from 1 (normal, not at all ill) to 7 (extremely ill).|Screening and Day 36|The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and had CGI-S scores at Screening and EOT.||CGI-S Score||Standard Deviation|Mean
772460|NCT00725725|Secondary|SCID-I/P With Psy Screen Score at EOT|The SCID-I/P with Psy Screen, Panic Disorder Module, was used to score participants' PD (w or w/o AP) as being current (full criteria for the disorder are met), IFR (there are no longer any symptoms or signs of the disorder, but it is still clinically relevant to note the disorder), or IPR (full criteria for the disorder were previously met, but currently only some of the symptoms or signs of the disorder remain) at EOT (Day 36). The SCID-I/P is a diagnostic exam used to assess for Axis-1 mental disorders.|Day 36|The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and had SCID-I/P with Psy Screen scores at EOT.||Participants|||Number
772461|NCT00725725|Secondary|Structured Clinical Interview for DSM-IV-TR Axis 1 Disorders, Patient Edition With Psychotic Screen (SCID-I/P With Psy Screen) Score at Screening|The SCID-I/P with Psy Screen, Panic Disorder Module was used to score participants' PD (with [w] or without [w/o] AGP) as being current (full criteria for the disorder met), in full remission (IFR) [there are no longer any symptoms or signs of the disorder, but it is still clinically relevant to note the disorder], or in partial remission (IPR) [full criteria for the disorder were previously met, but currently only some of the symptoms or signs of the disorder remain] at baseline (Screening). The SCID-I/P is a diagnostic exam used to assess for Axis-1 mental disorders.|Screening|The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and had SCID-I/P with Psy Screen scores at Screening.||Participants|||Number
772462|NCT00725725|Secondary|Change in PDSS Score From Baseline to Follow-Up|The mean change in PDSS score from baseline (Screening) to Follow-Up (Day 59) was calculated for each arm. The PDSS is a 7-item clinician-rated scale that assesses multiple dimensions of panic disorder severity (e.g., frequency of panic attacks). Each item is scored on a 5-point Likert scale (0 to 4) with the total score ranging from a minimum of 0 to a maximum of 28 (higher scores indicate greater panic disorder severity).|Screening and Follow-Up (Day 59)|The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and had PDSS scores at Screening and Follow-Up.||PDSS Score||Standard Deviation|Mean
772463|NCT00725725|Secondary|Change in PDSS Score From Baseline to Visit 4|The mean change in PDSS score from baseline (Screening) to Visit 4 (Day 22) was calculated for each arm. The PDSS is a 7-item clinician-rated scale that assesses multiple dimensions of panic disorder severity (e.g., frequency of panic attacks). Each item is scored on a 5-point Likert scale (0 to 4) with the total score ranging from a minimum of 0 to a maximum of 28 (higher scores indicate greater panic disorder severity).|Screening and Visit 4 (Day 22)|The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and PDSS scores at Screening and Visit 4.||PDSS Score||Standard Deviation|Mean
772464|NCT00725725|Primary|Change in Panic Disorder Severity Scale (PDSS) Score From Baseline to End-of-Treatment (EOT)|The mean change in PDSS score from baseline (Screening) to EOT (Day 36) was calculated for each arm. The PDSS is a 7-item clinician-rated scale that assesses multiple dimensions of panic disorder severity (e.g., frequency of panic attacks). Each item is scored on a 5-point Likert scale (0 to 4) with the total score ranging from a minimum of 0 to a maximum of 28 (higher scores indicate greater panic disorder severity).|Screening and Day 36|The Intent-to-Treat (ITT) population consisted of all participants who received ≥1 dose of double-blind study medication and had PDSS assessments at Screening and EOT.||PDSS Score||Standard Deviation|Mean
772465|NCT00725751|Secondary|Number of Participants Who Received Antiviral Treatment Who Were Also on Substitution Therapy|This measure was the number of all of the participants who received antiviral treatment who also received substitution therapy.|Day 1|Participants who received at least one dose of antiviral treatment.||participants|||Number
772466|NCT00725751|Secondary|Number of Participants Who Achieved Sustained Virologic Response (SVR)|SVR was defined as a hepatitis C virus (HCV) ribonucleic acid (RNA) value below the limit of detection by polymerase chain reaction (PCR) analysis. For participants with Genotype 1 or 4 completion of treatment was at Week 48; for participants with Genotype 2, 3, or 1 with low viral load or rapid virologic response, completion of therapy was at Week 24.|24 weeks after the end of treatment (i.e. 48 or 72 weeks depending on genotype)|All treated participants.||participants|||Number
786183|NCT00833690|Secondary|Serum Urate|From blood sample drawn after taking study drug that day|Visit 09 (Month 15; 450 +/- 7 days after Baseline Visit)|||mg/dL||Standard Deviation|Mean
772468|NCT00725842|Secondary|Number of Participants With Positive HCV-RNA at 72 Weeks Off-treatment|HCV-RNA virus levels were measured by polymerase chain reaction (PCR) assay 72 weeks post EOT with Peg-IFN alfa-2b + ribavirin. Participants with positive HCV-RNA at Week 72 post EOT were considered late relapsers.|72 weeks post EOT|77 of 90 participants had a negative HCV-RNA at Week 24 post EOT. These 77 were then evaluated for relapse at Week 72 post EOT.||participants|||Number
772469|NCT00725842|Secondary|Assessment of Pre-treatment Risk Factors of Relapse in Participants With Sustained Virologic Response|Baseline risk factors included but were not limited to viral load, genotype 1a versus 1b, histology, treatment compliance, gender, age, and substance abuse. Sustained virologic response was defined as having negative HCV-RNA at 24 weeks post EOT. Relapse was defined as positive HCV-RNA.|Baseline and 24 weeks post EOT|The planned analysis for this outcome measure was not performed due to insufficient enrollment.|||||
772470|NCT00725842|Secondary|Number of Participants With Rapid Virologic Response (RVR), Early Virologic Response (EVR), or Slow Response Who Relapsed After Treatment|Negative HCV-RNA at Week 4 of treatment with Peg-IFN alfa-2b + ribavirin was considered RVR; negative HCV-RNA at Week 12 of treatment with Peg-IFN alfa-2b + ribavirin was considered EVR; negative HCV-RNA between Week 12 and the end of treatment with Peg-IFN alfa-2b + ribavirin was considered a slow response. For participants who achieved RVR, EVR, or slow response, the relapse rate at 24 Weeks post EOT was to be determined on this observational study; relapse was defined as positive HCV-RNA.|24 weeks post EOT|The planned analysis for this outcome measure was not performed due to insufficient enrollment.|||||
772471|NCT00725842|Primary|Number of Participants With Positive Hepatitis C Virus (HCV)-Ribonucleic Acid (RNA) at 24 Weeks Off-treatment|HCV-RNA virus levels were measured by polymerase chain reaction (PCR) assay 24 weeks post end of treatment (EOT) with Peg-IFN alfa-2b + ribavirin. Participants with positive HCV-RNA were considered relapsers.|24 weeks post end of treatment (EOT)|Of the 97 participants who started the study, 7 were excluded from analysis because of protocol violations. 90 participants underwent HCV-RNA testing at Week 24 post EOT.||participants|||Number
772472|NCT00725920|Primary|Clinician Administered Posttraumatic Stress Disorder Scale|"The Clinician-Administered PTSD Scale (CAPS) [33] : is a structured interview developed to diagnose PTSD and rate its severity. It is comprised of 30-items to assess PTSD-related symptom frequency and severity. Total scores (sum of 3 clusters items) range from 0 to 136, with scores classified as follows: subclinical, from 0 to 19; mild, from 20 to 39; moderate, from 40 to 59; severe, from 60 to 79; extreme, 80 and above.
CAPS has 3 subscales characterized by the sum of all symptoms for each cluster: CAPS 1 (Revivesce/intrusive recolllections, 5 symptoms, score range: 0-28); CAPS 2 (avoidance, 7 symptoms, score range: 0-36); and CAPS 3 (hyperarousal, 5 symptoms, score range: 0-28).
CAPS scoring: each symptom scores range from 0 to 4, plus 0-2 scores for frequency, and 0-2 severity."|12 week|||Total CAPS score||Standard Deviation|Mean
772473|NCT00725985|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered. SAE: Any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition. Number of participants with AEs includes number of participants with both serious adverse events (SAEs) and non-SAEs.|Baseline up to Week 96|The ITT population included all randomized participants who received at least 1 dose of ITP study medication (cladribine or placebo) and had at least one safety assessment during the ITP.||Participants|||Number
772474|NCT00725985|Secondary|Number of Combined Unique Active (CUA) Lesions, New or Enlarging Time Constant 2 (T2) Lesions, and New or Persisting Time Constant 1 (T1) Gadolinium Enhanced (Gd+) Lesions Per Participant Per Scan|Number of CUA lesions, new or enlarging T2 lesions, and new or persisting T1 Gd+ lesions were measured by using magnetic resonance imaging (MRI) scans.|Week 96|The ITT population included all randomized participants who received at least 1 dose of ITP study medication (cladribine or placebo).||Lesions||Standard Deviation|Mean
772475|NCT00725985|Secondary|Time to Develop Multiple Sclerosis (MS) Conversion According to the Revised McDonald Criteria (2005) Represented by Kaplan-Meier Estimates of the Cumulative Percentage of Participants With McDonald MS|The McDonald criteria use dissemination in time and space established by magnetic resonance imaging (MRI) findings to provide a clinical diagnosis for MS. Dissemination in time is established by a new time constant 2 (T2) or gadolinium enhanced (Gd+) lesion found on a repeat MRI. Dissemination in space is established by the presence of any 3 of the following: 1 Gd+ lesion or 9 T2 bright lesions if there is no enhancement; greater than or equal to 1 infratentorial lesion; greater than or equal to 1 juxtacortical lesion; greater than or equal to 3 periventricular lesions. Kaplan-Meier estimates were provided for the cum. % of participants with McDonald MS over time.|Baseline up to Week 96|The ITT population included all randomized participants who received at least 1 dose of ITP study medication (cladribine or placebo).||Cum. % of participants with McDonald MS|||Number
772476|NCT00725985|Primary|Time to Clinically Definite Multiple Sclerosis (CDMS) Conversion Represented by Kaplan-Meier Estimates of the Cumulative Percentage of Participants With CDMS|Clinically definite multiple sclerosis (CDMS) according to the Poser criteria is defined as the occurrence of a second attack or a sustained increase in the expanded disability status scale (EDSS) Score. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. Sustained EDSS progression was defined as an increase in the EDSS score of greater than or equal to (>=) 1 point if baseline EDSS was between >= 1.0 and less than or equal to (=<) 4.5; or >= 1.5 points if baseline EDSS was 0, or >= 0.5 if baseline EDSS >= 5.0 over a period of at least 3 months. Kaplan-Meier estimates were provided for of the cumulative (cum.) percentage (%) of participants with CDMS over time. The probability of patients remaining event-free over time (from randomization) in each of the three treatment groups was displayed in the form of survival curves estimated using the non-parametric Kaplan-Meier method.|Baseline up to Week 96|The intent-to-treat (ITT) population included all randomized participants who received at least 1 dose of ITP study medication (cladribine or placebo).||Cum. % of participants with CDMS|||Number
772477|NCT00726037|Secondary|Optimal Time for Future Dendritic Cell Vaccine Administration|The goal is to define the optimal time with 95% sensitivity and 95% specificity for future dendritic cell vaccine administration|33 Days|Zero participants were analyzed, because the manufacturer withdrew support for the study due to a drug supply interruption|||||
772478|NCT00726037|Primary|T-reg Suppression From a Fractionated Dose of Ontak in Patients With Metastatic Pancreatic Cancer|The duration of T reg suppression from a fractionated dose of Ontak in patients will be measured in patients with metastatic pancreatic cancer.|days 8, 12 ,19,26 and 33 post administration|Zero participants were analyzed, because the manufacturer withdrew support for the study due to a drug supply interruption|||||
772479|NCT00726063|Secondary|Prosthesis Survival and Procedural Success||3 years||12/2017||||
772480|NCT00726063|Primary|Integration Success of the Implant||1 year|Number of implants surviving (lack of mobility) at the end of the study (time of analysis)||implants|Implants||Number
772481|NCT00726180|Primary|Standard Immunohistochemistry and Allred Scores Were to be Used to Measure the Estrogen Receptor (ER) Response Rate in Patients With ER-negative/Low, and Human Epidermal Growth Factor Receptor 2 (HER2)/Neu-positive Breast Cancer.||90 days|Only 1 patient was enrolled to this study, so no data was obtained.|||||
772482|NCT00726232|Secondary|Change From Baseline to Week 4 in Health-related Quality of Life|Health-related Quality of Life was assessed using the Global Health Status/Quality of Life Scale of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). This scale ranges from 0 to 100, with higher scores indicating higher quality of life.|Baseline and Week 4 (Cycle 2, Day 1)|Intent to treat population.||units on a scale||Standard Deviation|Mean
772483|NCT00726232|Secondary|Change From Baseline to Week 4 in Essential Thrombocythemia Symptoms|"Patients were asked to rate their symptoms on a scale of 0 (none) to 10 (worse possible) for the prior week giving the worst level of symptoms experienced during the preceding 7 days. A negative change from baseline score indicates improvement in symptoms.
For patients with essential thrombocythemia, queried symptoms included itching/pruritus, bone pain, night sweats, paresthesias (tingling or numbness), and weakness."|Baseline and Week 4 (Cycle 2, Day 1)|Essential Thrombocythemia intent to treat population who had symptom scores > 0 at baseline and for whom data was available.||participants||Standard Deviation|Mean
772484|NCT00726232|Secondary|Change From Baseline to Week 4 in Polycythemia Vera Symptoms|"Patients were asked to rate their symptoms on a scale of 0 (none) to 10 (worse possible) for the prior week giving the worst level of symptoms experienced during the preceding 7 days. A negative change from baseline score indicates improvement in symptoms.
For patients with Polycythemia Vera, queried symptoms included fever, itching/pruritus, bone pain and night sweats."|Baseline and Week 4 (Cycle 2, Day 1)|Polycythemia Vera intent to treat population who had symptom scores > 0 at baseline for whom data was available.||scores on a scale||Standard Deviation|Mean
772485|NCT00726232|Secondary|Percentage of Essential Thrombocythemia Participants Who Achieved Individual Components of Clinical Response at 36 Weeks|"The individual components of clinical response included:
Platelet count ≤ 400 x 10^9/L
White blood cell (WBC) count ≤ 10 x 10^9/L
50% reduction in spleen size
Absence of palpable splenomegaly"|Baseline and 36 weeks (Cycle 10, Day 1)|Essential thrombocythemia intent to treat population. 'N' indicates the number of patients for whom data was available for each component.||percentage of participants|||Number
772486|NCT00726232|Secondary|Percentage of Essential Thrombocythemia Participants Who Achieved Individual Components of Clinical Response at 24 Weeks|"The individual components of clinical response included:
Platelet count ≤ 400 x 10^9/L
White blood cell (WBC) count ≤ 10 x 10^9/L
50% reduction in spleen size
Absence of palpable splenomegaly"|Baseline and 24 weeks (Cycle 7, Day 1)|Essential thrombocythemia intent to treat population. 'N' indicates the number of patients for whom data was available for each component.||percentage of participants|||Number
772487|NCT00726232|Secondary|Percentage of Essential Thrombocythemia Participants Who Achieved Individual Components of Clinical Response at 4 Weeks|"The individual components of clinical response included:
Platelet count ≤ 400 x 10^9/L
White blood cell (WBC) count ≤ 10 x 10^9/L
50% reduction in spleen size
Absence of palpable splenomegaly"|Baseline and 4 weeks (Cycle 2, Day 1)|Essential thrombocythemia intent to treat population. 'N' indicates the number of patients for whom data was available for each component.||percentage of participants|||Number
772488|NCT00726232|Secondary|Percentage of Polycythemia Vera Participants Who Achieved Individual Components of Clinical Response at 36 Weeks|"The individual components of clinical response included:
Hematocrit (Hct) < 45% without phlebotomy
Absence of palpable splenomegaly
50% reduction in spleen size
Platelet count ≤ 400 x 10^9/L
White blood cell (WBC) count ≤ 10 x 10^9/L"|Baseline and Week 36 (Cycle 10, Day 1)|Polycythemia Vera intent to treat population for whom data was available. 'N' indicates the number of patients for whom data was available for each component.||percentage of participants|||Number
772489|NCT00726232|Secondary|Percentage of Polycythemia Vera Participants Who Achieved Individual Components of Clinical Response at 24 Weeks|"The individual components of clinical response included:
Hematocrit (Hct) < 45% without phlebotomy
Absence of palpable splenomegaly
50% reduction in spleen size
Platelet count ≤ 400 x 10^9/L
White blood cell (WBC) count ≤ 10 x 10^9/L"|Baseline and Week 24 (Cycle 7, Day 1)|Polycythemia Vera intent to treat population for whom data was available. 'N' indicates the number of patients for whom data was available for each component.||percentage of participants|||Number
772490|NCT00726232|Primary|Percentage of Essential Thrombocythemia (ET) Participants With a Confirmed Clinical Partial Response (PR) or Complete Response (CR)|"For a confirmed response all criteria must have been sustained for at least 2 months.
Complete Clinical Response:
Platelet count < 400 x 10^9/L
White blood cell count < 10 x 10^9/L with normal differential and Hematocrit ≤ upper limit of normal
Absence of sustained (> 2 weeks) anemia or leucopenia based on institutional normal ranges
Absence of systemic ET symptoms (pruritus, bone pain, weakness, night sweats, paresthesias)
Absence of palpable splenomegaly
Partial Clinical Response:
Platelet count < 400 x 10^9/L
50% reduction in palpable splenomegaly"|Assessed after 2 cycles (56 days) of treatment on Day 1 of Cycle 3.|Essential thrombocythemia intent to treat population, including all patients who took at least 1 dose of study drug. One patient in the 50 mg QD group did not have a response assessment at Cycle 3, Day 1.||percentage of participants|||Number
772491|NCT00726232|Secondary|Percentage of Polycythemia Vera Participants Who Achieved Individual Components of Clinical Response at 12 Weeks|"The individual components of clinical response included:
Hematocrit (Hct) < 45% without phlebotomy
Absence of palpable splenomegaly
50% reduction in spleen size
Platelet count ≤ 400 x 10^9/L
White blood cell (WBC) count ≤ 10 x 10^9/L"|Baseline and Week 12 (Cycle 4, Day 1)|Polycythemia Vera intent to treat population for whom data was available.||percentage of participants|||Number
786184|NCT00833690|Secondary|Serum Urate|From blood sample drawn after taking study drug that day|Visit 08 (Month 12; 360 +/- 7 days after Baseline Visit)|||mg/dL||Standard Deviation|Mean
772492|NCT00726232|Primary|Percentage of Polycythemia Vera Participants With a Confirmed Clinical Partial Response (PR) or Complete Response (CR)|"For a confirmed response all criteria must have been sustained for at least 2 months.
CR:
Hematocrit < 45% in men and < 42% in women
No phlebotomy for 1 month
No palpable splenomegaly
White blood cells < 10 x 10^9/L with normal differential and platelets < 400 x 10^9/L
No sustained leucopenia or thrombocytopenia (>2 weeks)
No systemic PV symptoms (pruritus, night sweats, bone pain, fever, weight loss)
PR:
Hematocrit < 45% in men and < 42% in women
50% reduction in phlebotomy requirements from 6 months before treatment started
50% reduction in palpable splenomegaly"|Assessed after 2 cycles (56 days) of treatment on Day 1 of Cycle 3|Polycythemia Vera intent to treat population, including all patients who took at least 1 dose of study drug.||percentage of participants|||Number
772493|NCT00726375|Secondary|The Number of Patients in Complete Remission (CR) at Four Weeks.|"Estimate the proportion of patients in complete remission (CR) at four weeks who remain alive and never require additional therapy four weeks after the last dose of etanercept.
Complete remission is defined as the resolution of all manifestations of GVHD (Graft Versus Host Disease) within the first four weeks of treatment. All organs must have a Grade 0."|28 days|||patients|||Number
772494|NCT00726375|Primary|The Percentage of Patients Who Progress Within 28 Days of Initiation of Etanercept Treatment|We hypothesized that treatment of grade 1 acute GVHD (Graft Versus Host Disease) with etanercept would reduce the proportion of patients who progressed to grade 2 to 4 acute GVHD within 4 weeks of diagnosis from 58%, historically observed at our institution, to 38%.|28 days|||percentage of patients|||Number
772495|NCT00726414|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)] for Quinine Sulfate|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hours after drug administration.|Data from all 22 subjects enrolled in this study were used in the statistical analysis.||ng-hr/mL||Standard Deviation|Mean
772496|NCT00726414|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] for Quinine Sulfate|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hours after drug administration.|Data from all 22 subjects enrolled in this study were used in the statistical analysis.||ng-hr/mL||Standard Deviation|Mean
772497|NCT00726414|Primary|Maximum Plasma Concentration (Cmax) for Quinine Sulfate|The maximum or peak concentration that Quinine Sulfate reaches in the plasma.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hours after drug administration.|Data from all 22 subjects enrolled in this study were used in the statistical analysis.||ng/mL||Standard Deviation|Mean
772498|NCT00726453|Secondary|Stent Thrombosis (ST)|Stent Thrombosis (ST) (as determined by historic and ARC definitions).|12 months|||percentage of participants|||Number
772499|NCT00726453|Secondary|Target Vessel MI|Target Vessel MI (as determined by extended historical and ARC definitions).|12 months|||percentage of eligible participants|||Number
772500|NCT00726453|Secondary|Death||12 months|||percentage of participants|||Number
772501|NCT00726453|Secondary|Major Adverse Cardiac Event (MACE)|Major Adverse Cardiac Event (MACE) composite endpoint and each individual component (death, Target Vessel MI (Q wave and non-Q wave), emergent coronary bypass surgery (CABG), or clinically-driven repeat Target Lesion Revascularization (TLR) by percutaneous or surgical methods).|12 months|||percentage of participants|||Number
772502|NCT00726453|Secondary|Target Vessel Failure (TVF)|Target Vessel Failure (TVF) composite endpoint and each individual component (Cardiac Death, Target Vessel MI, or clinically-driven Target Vessel Revascularization (TVR) by percutaneous or surgical methods).|12 months|||percentage of participants|||Number
772503|NCT00726453|Primary|Target Lesion Failure (TLF)|Target Lesion Failure (TLF) at 12 months post-procedure, defined as Cardiac Death, Target Vessel Myocardial Infarction (TVMI) (Q wave and non-Q wave) or clinically-driven Target Lesion Revascularization (TLR) by percutaneous or surgical methods.|12 Months|||percentage of participants|||Number
772504|NCT00726557|Primary|Number of Participants Who Tolerated Treatment With PegIntron 1.5 mcg/kg/Week + Rebetol 10.6 mg/kg/Week|Tolerability of the treatment was measured by number of participants with complete treatment.|Assessed at the end of treatment|All enrolled participants||participants|||Number
772505|NCT00726557|Primary|Number of Drug-substituted Participants Who Achieved Sustained Virological Response (SVR) With PegIntron 1.5 μg/kg/Week and Rebetol (10.6 mg/kg/Day) in Substitution Centers Under Routine Conditions|Participants who achieved SVR (sustained virological response) at the end of treatment (24 weeks for genotypes 2,3 and 48 weeks for genotypes 1,4) were analyzed for sustained response at the end of the follow-up period (24 weeks after end of treatment). SVR is defined as having negative HCV-RNA (hepatitis C virus ribonucleic acid).|End of Follow-up (Week 48 or Week 72, depending on genotype)|Participants who achieved SVR at the end of treatment (24 weeks for genotypes 2,3 and 48 weeks for genotypes 1,4)||Participants|||Number
772506|NCT00726609|Primary|Number of Participants Reporting Adverse Drug Reactions.|"The severity of an Adverse Drug Reaction is determined on the basis of the following definitions:
Mild: The abnormality, symptom or event is noticed but well tolerated.
Moderate: Symptoms impair normal activities and may require intervention.
Severe: Clinical status is significantly impaired, normal activity is no longer possible, intervention is required."|Before starting treatment with posaconazole, during treatment, and until 100 days after treatment.|||Participants|||Number
772507|NCT00726622|Secondary|Bowel and Stoma Function||Up to 5 years post surgery||||||
772508|NCT00726622|Secondary|Bowel Function||Up to 5 years post surgery||||||
772509|NCT00726622|Secondary|Quality of Life and Sexual Function||Up to 5 years post surgery||||||
772510|NCT00726622|Secondary|Overall Survival||Up to 5 years post surgery||||||
772511|NCT00726622|Secondary|Local Pelvic Recurrence Rates||Up to 2 years post surgery||||||
772512|NCT00726622|Secondary|Disease-free Survival||Up to 2 years post surgery||||||
772513|NCT00726622|Secondary|Operative Times|Open to close operative time.|During surgery|Of the 225 patients that received intervention as randomized in Arm 1: Open laparotomy and rectal resection, 3 patients were excluded from the analysis due to improper consent. All 240 patients from Arm 2 that received intervention as randomized were included in the analysis.||minutes||Standard Deviation|Mean
772514|NCT00726622|Secondary|Use of Pain Medication|The number of days patients received parenteral narcotics post-surgery were counted.|Two weeks post-surgery|Of the 225 patients that received intervention as randomized in Arm 1: Open laparotomy and rectal resection, 3 patients were excluded from the analysis due to improper consent. All 240 patients from Arm 2 that received intervention as randomized were included in the analysis.||days||Standard Deviation|Mean
772515|NCT00726622|Secondary|Length of Stay|The mean number of days required post-surgery to the when the patient was released from the hospital was calculated.|Two weeks post-surgery|Of the 225 patients that received intervention as randomized in Arm 1: Open laparotomy and rectal resection, 3 patients were excluded from the analysis due to improper consent. All 240 patients from Arm 2 that received intervention as randomized were included in the analysis.||days||Standard Deviation|Mean
772516|NCT00726622|Secondary|Circumferential Margin > 1 mm|The distance between the closest tumor to the cut edge of the tissue was measure post-resection. The percentage of patients with >1mm between the closest tumor to the cut edge of the tissue was calculated with a binomial 95% confidence interval.|At time of surgery|Of the 225 patients that received intervention as randomized in Arm 1: Open laparotomy and rectal resection, 3 patients were excluded from the analysis due to improper consent. All 240 patients from Arm 2 that received intervention as randomized were included in the analysis.||percentage of participants||95% Confidence Interval|Number
772517|NCT00726622|Secondary|Negative Distal Resected Margin|The percentage of patients with negative distal margin (>1 mm between the closest tumor to the cut edge of the tissue) was calculated along with binomial 95% confidence intervals.|At time of surgery|Of the 225 patients that received intervention as randomized in Arm 1: Open laparotomy and rectal resection, 3 patients were excluded from the analysis due to improper consent. All 240 patients from Arm 2 that received intervention as randomized were included in the analysis.||percentage of participants||95% Confidence Interval|Number
772518|NCT00726622|Secondary|Completeness of Total Mesorectal Excision (Complete or Nearly Complete)|"Complete total mesorectal excision was defined as a rectal resection specimen having smooth surface of mesorectal fascia with all fat contained in the enveloping fascia to a level 5 cm below the tumor for tumor-specific total mesorectal excision for upper rectal cancer, or the entire mesorectal envelope present for low rectal cancer. Nearly complete was defined as a rectal resection specimen having the mesorectal envelope intact except for defects no more than 5 mm deep, with no loss of mesorectal fat.
The percentage of patients with complete or nearly complete mesorectal excision was calculated along with the binomial 95% CI."|At time of surgery|Of the 225 patients that received intervention as randomized in Arm 1: Open laparotomy and rectal resection, 3 patients were excluded from the analysis due to improper consent. All 240 patients from Arm 2 that received intervention as randomized were included in the analysis.||percentage of participants||95% Confidence Interval|Number
772519|NCT00726622|Primary|Comparing Laparoscopic-assisted Resection to Open Rectal Resection for Rectal Cancer as Measured by the Percentage of Patients With Successful Resection Based on Pathological Evaluation.|"The primary endpoint will be a composite endpoint of oncologic factors which are indicative of an adequate surgical resection based on pathologic evaluation.
Primary endpoint parameters:
Circumferential margin > 1 mm
Negative distal margin
Completeness of total mesorectal excision (TME) A complete TME is a rectal resection specimen that has an intact mesorectum and covering peritoneal envelope all the way to the level of rectal transection with no coning in of the mesorectum above the point of transection. The surface of the peritoneal covering should be smooth and shiny with no defects exposing the underlying fat.
All three criteria must be met for a resection to be deemed adequate. Laparoscopic-assisted resection will be compared to Open rectal resection to determine if it is non-inferior."|At time of Surgery|Of the 225 patients that received intervention as randomized in Arm 1: Open laparotomy and rectal resection, 3 patients were excluded from the analysis due to improper consent. All 240 patients from Arm 2 that received intervention as randomized were included in the analysis.||percentage of participants||95% Confidence Interval|Number
772520|NCT00726661|Secondary|Number of Participants With Arterial Thromboembolic Events, Venous Thromboembolic Events, Left Ventricular Systolic Dysfunction, and Peripheral Neuropathy|All AEs were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3 as Grade 1 (mild), Graded 2 (moderate), Grade 3 (severe), Grade 4 (very severe, life threatening, or disabling), and Grade 5 (death related to AE). Venous Thromboembolic Events (VTEs) included all Grade 4 or of more severity of deep vein thrombosis, pulmonary embolus; Arterial Thromboembolic Events (ATEs) Included new or worsening angina pectoris, myocardial infarction, stroke, transient ischemic attack, peripheral arterial ischemia of any NCI CTCAE grade; Left Ventricular Systolic Dysfunction (LVSD) included congestive heart failure) of NCI CTCAE Grade 2 or of more severity; Peripheral Neuropathy (PN) included sensory and/or motor events of Grade 3 or of more severity.|Approximately 4.5 years|All enrolled participants were considered for this outcome measure.||participants|||Number
772521|NCT00726661|Secondary|Number of Participants With Any Adverse Events, Any Serious Adverse Events, Any AEs Leading to Early Treatment Discontinuation, and Adverse Events Leading to Hospitalization or Death|An Adverse Event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An Serious Adverse Events (SAE) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.|Approximately 4.5 years|All enrolled participants were considered for this outcome measure.||participants|||Number
772522|NCT00726661|Secondary|Number of Hormone Receptor-positive Participants Who Initiated Cytotoxic Chemotherapy Following Discontinuation|Participants were assessed quarterly for progressive events and treatment status.|Approximately 4.5 years|All enrolled participants in Hormonal Therapy Cohort were considered for this outcome measure. n = number of participants evaluated at that particular time point.||participants|||Number
774921|NCT00753012|Primary|Cardiac Function Index (E/A Ratio)|Left ventricle diastolic function index, following 3-6 months of stimulant medication, according to cardiac ultrasound (transthoracic echocardiogram; TTE)|3-6 months|||cm/sec/cm/sec||Standard Deviation|Mean
772523|NCT00726661|Secondary|Number of Participants With Tumor Response|The tumor response was measured as complete response, partial response, stable disease, progressive disease, or clinical deterioration based on their best overall response. The tumor response was assessed by the investigator according to the method of his or her choice. The choices included computed tomography (CT) scan, magnetic resonance imaging (MRI), bone scan, X-ray, Positron emission tomography (PET) or CT PET, physical exam, laboratory exam, and other method.|Approximately 4.5 years|All enrolled participants were considered for this outcome measure.||participants|||Number
772524|NCT00726661|Secondary|Overall Survival|Overall survival was defined as the time from enrolment to death of any cause.|Approximately 4.5 years|All enrolled participants were considered for this outcome measure.||months||95% Confidence Interval|Median
772525|NCT00726661|Primary|Progression Free Survival|Progression free survival was defined as the time from enrollment to progression or death of any cause, whichever came first. The disease response status was assessed by the investigator according to the method of his or her choice. The choices included computed tomography (CT) scan, magnetic resonance imaging (MRI), bone scan, X-ray, Positron emission tomography (PET) or CT PET, physical exam, laboratory exam, and other method.|Approximately 4.5 years|All enrolled participants were considered for this outcome measure.||months||95% Confidence Interval|Median
772526|NCT00726713|Secondary|(Exploratory) Change From Baseline in Levels Potential Antioxidant (PAO) at Week 24|(Exploratory) To determine if Metanx® affects a subject's plasma oxidative stress and inflammatory markers levels including Potential Antioxidant (PAO)|Analyte levels were taken at 0 (Baseline) and 24 weeks|||µmol/L||Standard Deviation|Mean
772527|NCT00726713|Secondary|(Exploratory) Change From Baseline in Levels of Hs-CRP at Week 24|(Exploratory) To determine if Metanx® affects a subject's plasma oxidative stress and inflammatory markers levels including hs-CRP|Analyte levels were taken at 0 (Baseline) and 24 weeks|||mg/L||Standard Deviation|Mean
772528|NCT00726713|Secondary|Change From Baseline in Total Homocysteine at Week 16 and 24|To determine if Metanx® (compared to placebo) affects change in subjects total homocysteine levels|Change from Baseline in Plasma Marker Levels at 0 (Baseline), 16, and 24 weeks|||µmol/L||Standard Deviation|Mean
772529|NCT00726713|Secondary|(Exploratory) Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Question Inventory at Week 24|The Hospital Anxiety and Depression Scale (HADS) consists of a 14-item questionnaire that provides a measurement of depression. Each item is rated on a 4-point scale, giving a maximum scores of 21 for the most severe depression. Depression was evaluated using the Hospital Anxiety and Depression Scale (HADS) question inventory at Baseline, and 24-week evaluation visits|HADS Scores scores were taken at 0 (Baseline) and 24 weeks|||units on a scale (0-21)||Standard Deviation|Mean
772530|NCT00726713|Secondary|(Exploratory) Change From Baseline in Levels of IL-6 and TNF-α, at Week 24|(Exploratory) To determine if Metanx® affects a subject's plasma oxidative stress and inflammatory marker levels, including IL-6 and TNF-α|Analyte levels were taken at 0 (Baseline) and 24 weeks|||pg/mL||Standard Deviation|Mean
772531|NCT00726713|Secondary|Change From Baseline in 10-point Visual Analog Scale(VAS) at Week 24|"To determine if Metanx® (compared to placebo) affects a subject’s lower extremity pain level using a 10-point Visual Analog Scale at Baseline and 24-week evaluation visits.
The Visual Analog Scale (VAS) measures a patients sensation of pain. A 10-cm visual analog scale is used. A measurement on the 10 cm analog scale is used to quantify the level of pain indicated with 0 cm indicating no pain and 10 cm indicating the worst pain imaginable."|VAS scores were taken at 0 (Baseline) and 24 weeks|||units on a scale (0-10)||Standard Deviation|Mean
772532|NCT00726713|Secondary|Change From Baseline in SF-36 MCS and SF-36 PCS at Week 24|"To determine if Metanx® (compared to placebo) affects a subject’s “quality of life” as determined by the SF-36 questionnaire
The Short Form- 36 Mental Component Summary (SF-36 MCS) and SF-36 Physical Component Summary (SF-36 PCS) both measure health related quality of life, the MCS quantifying mental health and the PCS quantifying physical function. They are both scored on 100 point scales with 0 representing the worst possible outcome and 100 representing the most optimal possible scoring"|SF-36 MCS and SF-36 PCS scores were measured at 0 (Baseline) and 24 weeks|||units on a scale (0-100)||Standard Deviation|Mean
772533|NCT00726713|Secondary|Change From Baseline in Plasma Marker Levels of Total Folate and Total Methyl Malonic Acid (MMA) at Week 16 and 24|To determine if Metanx® (compared to placebo) affects a change in subject's total folate and total methyl malonic acid (MMA) at week 16 and 24|Change from Baseline in Plasma Marker Levels at 0 (Baseline), 16, and 24 weeks|||nmol/L||Standard Deviation|Mean
772534|NCT00726713|Secondary|Change From Baseline in Neuropathy Disability Score (NDS)at Week 16 and 24|"This outcome was taken to determine if Metanx® (compared to placebo) has an effect on clinical examination as determined by the Neuropathy Disability Score (NDS)
The Neuropathy Disability Score (NDS) evaluates the severity of individual symptoms of neuropathy. A simple visual numeric distress scale is used that ranges from 0 to 10. The most favorable score is 0, which indicates an absence of symptoms. The most severe symptoms possible would be recorded as a score of 10."|NDS scores were taken at 0 (Baseline), 16, and 24 weeks|||units on a scale (0-10)||Standard Deviation|Mean
772535|NCT00726713|Secondary|Change From Baseline in Neuropathy Total Symptom Score-6 (NTSS-6)|"This measure was taken to determine if Metanx® (compared to placebo) changes neuropathic symptoms as evaluated by the Neuropathy Total Symptom Score-6 (NTSS-6)
The Neuropathy Total Symptom Score-6 Scale (NTSS-6) is a validated scale that evaluates individual neuropathy sensory symptoms in patients with diabetes mellitus (DM) and diabetic peripheral neuropathy (DPN). This scale was a modified 6 item scale that consists of yes or no questions. Scores range between 0 and 21.96, a higher score indicates greater severity of symptoms. After adjusting for baseline measurements scores are reflected as negative numbers. Negative numbers indicate improvement in symptoms. ie. a change from baseline after 24 weeks of -2 would be a greater improvement than a change in baseline of -1 after 24 weeks."|NTSS-6 scores were taken at 0 (Baseline), 16, and 24 weeks|||units on a scale (0-6)||Standard Deviation|Mean
772536|NCT00726713|Primary|Change From Baseline in Vibration Perception Threshold (VPT) at 24 Weeks|Vibration Perception Threshold (VPT) 25-45 volts at hallux on either leg as measured by VPT meter on the great toe of each foot. Mean VPT averaged across both toes.|VPT was measured a 0 (baseline), and 24 weeks|||volts||Standard Deviation|Mean
772809|NCT00734162|Secondary|Change From Baseline in Z-score for Spine BMD at Week 72|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 72|Participants in the Safety Analysis Set with available data were analyzed.||z-score||Standard Deviation|Mean
772537|NCT00726739|Secondary|Immune Response|Immune responses is be assessed by Delayed Type Hypersensitive (DTH) responses to LMI, IFN-γ production by CD8 T cells using the ELISPOT assay, and CD8 T cell binding to HLA-A2 multimers complexed with melanoma-derived peptides (pentamer analysis). DTH reactions are determined at 48 hours by measuring the largest diameter and right angle diameter of the area of induration and calculating the mean. DTH responses are recorded as present or absent but cannot be used as a quantitative measure of immune activation.|48 hours After Study Medication|||participants|||Number
772538|NCT00726739|Secondary|Overall Survival at 1 Year|One year survival (alive at 1 year from randomization) rate of each treatment group.|1 Year|||Percentage of patients|||Number
772539|NCT00726739|Secondary|Overall Survival at 2 Years|Two year survival (alive at 2 years from randomization) rate of each treatment group.|2 Years|||percentage of patients|||Number
772540|NCT00726739|Secondary|Clinical Response of Lesion(s)|Beginning at 2 months Through End of Treatment: To determine clinical response of each treatment group - Best Clinical response will be determined using Solid Tumor Response Criteria (RECIST). Complete Response (CR) = complete disappearance of all target lesions. Partial Response (PR) = At least a 30% decrease in sum of longest diameters of target lesions. Progressive Disease (PD) = At least a 20% increase in sum of longest diameters of target lesions. Stable Disease (SD) = Neither sufficient shrinkage to qualify for PR or PD.|Month 2 through Month 12|All patients who received at least one dose of study treatment are included. One patient who was originally screened did not receive treatment due to brain metastasis.||participants|||Number
772541|NCT00726739|Primary|Median Time of Progression-free Survival|Progression free survival (PFS) was measured in months from date of randomization to date of disease progression, or date of death. For patients who died without tumor progression, PFS assumes their deaths are randomly related to tumor progression. Therefore, PFS includes deaths if they came first.|From Date of Randomization to Date of Disease Progression or Last Contact - up to 2 years.|All patients who received at least one dose of study treatment are included. One patient who was originally screened and randomized did not receive treatment due to brain metastasis. This patient was included in PFS analysis based on the intent-to-treat principle, but was excluded from the evaluation of adverse events.||Months||Full Range|Median
772542|NCT00726752|Secondary|Number of Participants With Adverse Events|Number of participants with any adverse events, adverse events graded as Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Grade 3 or higher , serious adverse events, and adverse events resulted in discontinuation.|Up to 470 days of treatment plus 28-days follow-up|Safety analysis set was defined as all enrolled participants who received the study drug at least once in this study (same as the full analysis set:FAS).||participants|||Number
772543|NCT00726752|Secondary|Number of Participants With Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), and Progression of Disease (PD) According to the Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0)|CR was defined as the disappearance of all target and nontarget lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters (SLD) of the targeted lesions. CR and PR had to be documented on 2 occasions separated by at least 4 weeks. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify as PD being demonstrated during the first 8 weeks. PD was defined as at least a 20% increase in the SLD of target lesions compared to the smallest SLD since the study treatment started.|Up to 470 days|Anti-tumor response analysis set was defined as all participants with at least 1 target lesion according to RECIST and who received at least 1 dose of study drug.||participants|||Number
772544|NCT00726752|Secondary|Percent Change From Baseline in Soluble Vascular Endothelial Growth Factor Receptor 1, 2, and 3 (s-VEGFR1, s-VEGFR2 and s-VEGFR3), Vascular Endothelial Growth Factor (VEGF), Soluble Stem Cell Factor Receptor (s-KIT )|Percent change from baseline is obtained from (observed value minus baseline value) divided by baseline value multiplied by 100 in each parameter, i.e., s-VEGFR1, VEGFR2, s-VEGFR3, s-KIT, and VEGF|Prior to the initial dose (baseline) and Day 1 of Cycle 2|Pharmacodynamic analysis set was defined as all enrolled participants who received at least 1 dose of the study medication and who completed pharmacodynamic blood sampling for at least 1 day.||percent||Full Range|Median
772545|NCT00726752|Secondary|Multiple Dose: Accumulation Ratio for Cmax (Rac Cmax) and Accumulation Ratio for AUCtau (Rac AUCtau)|Rac Cmax is obtained from Cmax (Cycle 1, Day 15) divided by Cmax (Cycle 1, Day 1) Rac AUCtau is obtained from AUCtau (Cycle 1, Day 15) divided by AUCtau (Cycle 1, Day 1)|Cycle 1 Day 15 predose in the morning, and 0.5, 1, 2, 4, 8 and 12 hour postdose|Pharmacokinetic analysis set was defined as all enrolled participants who received at least 1 dose of the study medication and who completed pharmacokinetic blood sampling for at least 1 day.||ratio||Standard Deviation|Mean
772546|NCT00726752|Secondary|Multiple Dose: Time to Reach Maximum Observed Plasma Concentration (Tmax)|Tmax at multiple dosing|Cycle 1 Day 15 predose in the morning, and 0.5, 1, 2, 4, 8 and 12 hour postdose|Pharmacokinetic analysis set was defined as all enrolled participants who received at least 1 dose of the study medication and who completed pharmacokinetic blood sampling for at least 1 day.||hours||Full Range|Median
772547|NCT00726752|Secondary|Multiple Dose: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)|The dosing interval was 12 hours in this study.|Cycle 1 Day 15 predose in the morning, and 0.5, 1, 2, 4, 8 and 12 hour postdose|Pharmacokinetic analysis set was defined as all enrolled participants who received at least 1 dose of the study medication and who completed pharmacokinetic blood sampling for at least 1 day.||ng*h/mL||Standard Deviation|Mean
772548|NCT00726752|Secondary|Multiple Dose: Maximum Observed Plasma Concentration (Cmax)|Cmax at multiple dosing|Cycle 1 Day 15 predose in the morning, and 0.5, 1, 2, 4, 8 and 12 hour postdose|Pharmacokinetic analysis set was defined as all enrolled participants who received at least 1 dose of the study medication and who completed pharmacokinetic blood sampling for at least 1 day.||ng/mL||Standard Deviation|Mean
772549|NCT00726752|Primary|Single Dose: Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Predose, 0.5, 1, 2, 4, 6, 8, 10, 24, and 32-hour postdose|Pharmacokinetic analysis set was defined as all enrolled participants who received at least 1 dose of the study medication and who completed pharmacokinetic blood sampling for at least 1 day.||hours||Standard Deviation|Mean
772550|NCT00726752|Primary|Single Dose: Time to Reach Maximum Observed Plasma Concentration (Tmax)||Predose, 0.5, 1, 2, 4, 6, 8, 10, 24, and 32-hour postdose|Pharmacokinetic analysis set was defined as all enrolled participants who received at least 1 dose of the study medication and who completed pharmacokinetic blood sampling for at least 1 day.||hours||Full Range|Median
772551|NCT00726752|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to Time Infinity (AUCinf)|AUCinf is obtained from AUC (0 - t) plus AUC (t - infinity).|Predose, 0.5, 1, 2, 4, 6, 8, 10, 24, and 32-hour postdose|Pharmacokinetic analysis set was defined as all enrolled participants who received at least 1 dose of the study medication and who completed pharmacokinetic blood sampling for at least 1 day.||ng*hr/mL||Standard Deviation|Mean
772552|NCT00726752|Primary|Single Dose: Maximum Observed Plasma Concentration (Cmax)||Predose, 0.5, 1, 2, 4, 6, 8, 10, 24, and 32-hour postdose|Pharmacokinetic analysis set was defined as all enrolled participants who received at least 1 dose of the study medication and who completed pharmacokinetic blood sampling for at least 1 day.||ng/mL||Standard Deviation|Mean
772553|NCT00726830|Secondary|Number of Participants With 30% Reduction in Total Summary Score for the Individual Composite Drug Toxicity Score (CDTS) Items||28 days||||||
772554|NCT00726830|Primary|Number of Participants With at Least a 3-point Reduction in Pain Score on the M.D. Anderson Symptom Inventory (MDASI)|MDASI questionnaire completed on days 8, 15, and 22 after enrollment. The ‘primary success’ is defined as a 3-point reduction in pain score on the MDASI. Scores from baseline and from four weeks later compared using the MDASI average pain intensity on a scale of 0 (no pain) to 10 (worst pain).|28 days|No Analysis accomplished as there is not sufficient participant data to meet the study end points.|||||
772555|NCT00726882|Secondary|Number of Participants With Serious Adverse Events Related to Study Procedures|Only serious adverse events that the investigator considered causally related to study procedures (i.e., venipuncture) were to be collected in this study. A serious adverse event was defined as any untoward medical occurrence in a clinical investigation subject that the investigator believed to be causally related to a study procedure and met at least 1 of the following criteria: death, life-threatening, hospitalization or prolongation of hospitalization, congenital anomaly, persistent or significant disability/incapacity, important medical event requiring medical or surgical intervention to prevent serious outcome, elective or spontaneous abortion.|48 weeks|||participants|||Number
772556|NCT00726882|Primary|Persistence of Resistance-Associated Variants and Phenotypic Resistance|Participants in studies M10-351 (NCT00851890) and M10-380 (NCT00696904) were analyzed for persistence of resistance-associated variants by comparing post-treatment clonal sequence data with baseline and on-treatment sequence data from M10-351 and M10-380 studies to assess amino acid changes. Phenotypic resistance to ABT-333 was assessed by calculating the fold change in half maximal effective concentration (EC50) of post-treatment samples compared with the EC50 value for the corresponding baseline sample as determined for M10-351 and M10-380 studies. The number of participants with variants at resistance-associated amino acid positions and phenotypic resistance at post-treatment time points are presented. Variants are included if the absolute percent of total clones encoding the variant was at least 10% greater than at baseline in a post-treatment sample.|Baseline (day of study completion or early discontinuation from the prior ABT-333 clinical study), 48 weeks|Resistance analyses included all participants who received ABT-333 in the previous study who had sufficient HCV RNA recovered from samples collected during this study for genotypic and phenotypic analysis to proceed. m, n = the number of evaluable participants for the analysis specified for M10-380 and M10-351, respectively.||participants|||Number
772557|NCT00726895|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hours after drug administration.|Plasma concentration data for 23 of the 24 enrolled subjects were used in the statistical analysis. Subject number 12 dropped from the study prior to period II (Treatment A) dosing. Treatment A, Dose Adjusted to 2 x 324 mg was a statistical adjustment only used to evaluate for dose proportionality.||ng-hr/mL||Standard Deviation|Mean
772558|NCT00726895|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hours after drug administration.|Plasma concentration data for 23 of the 24 enrolled subjects were used in the statistical analysis. Subject number 12 dropped from the study prior to period II (Treatment A) dosing. Treatment A, Dose Adjusted to 2 x 324 mg was a statistical adjustment only used to evaluate for dose proportionality.||ng-hr/mL||Standard Deviation|Mean
772559|NCT00726895|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that the drug reaches in the plasma.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hours after drug administration.|Plasma concentration data for 23 of the 24 enrolled subjects were used in the statistical analysis. Subject number 12 dropped from the study prior to period II (Treatment A) dosing. Treatment A, Dose Adjusted to 2 x 324 mg was a statistical adjustment only used to evaluate for dose proportionality.||ng/mL||Standard Deviation|Mean
772560|NCT00726986|Secondary|Safety|Number of patients that experienced grade 3-4-5 treatment related toxicities. Toxicity was graded by the National Cancer Institute Common Terminology Criteria version 3.0.|Treatment repeats every 21 days for 4 courses in the absence of unacceptable toxicity.|Patients who received at least one dose of the study drug were considered evaluable for both toxicity and response.||participants|||Number
772561|NCT00726986|Secondary|Response Rate|"The Response Evaluation Criteria in Solid Tumors (RECIST) were used to assess response to the treatment.
Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started"|reevaluated for response every 8 weeks|Patients who received at least one dose of the study drug were considered evaluable for both toxicity and response.||participants|||Number
786185|NCT00833690|Secondary|Serum Urate|From blood sample drawn after taking study drug that day|Visit 07 (Month 9; 270 +/- 7 days after Baseline Visit)|||mg/dL||Standard Deviation|Mean
772562|NCT00726986|Secondary|Median Overall Survival|Overall survival is measured from the date of chemotherapy treatment (date of cycle 1 of induction chemotherapy) until death and censored at the date of last follow-up for survivors.|1-year|Patients who received at least one dose of the study drug were considered evaluable for both toxicity and response.||months||95% Confidence Interval|Median
772563|NCT00726986|Primary|Progression-free Survival(PFS)|PFS is defined as the duration of time from start of treatment to time of progression or death, whichever comes first.|1-year|Patients who received at least one dose of the study drug were considered evaluable for both toxicity and response.||months||95% Confidence Interval|Median
772564|NCT00726999|Primary|Amount of Morphine Consumed (mg/kg/hr)||Day 2|||mg/kg/h||Standard Deviation|Mean
772565|NCT00726999|Primary|Amount of Morphine Consumed (mg/kg/hr)||Day 1|||mg/kg/h||Standard Deviation|Mean
772566|NCT00726999|Secondary|Side Effect Occurrence|The number of episodes of/occurrence of side effects was monitored in both groups.|First 10 days after surgery||||||
772567|NCT00726999|Primary|Amount of Morphine Consumed (mg/kg/hr)|Patients are taken to the PARU immediately after surgery, and typically remain for a period of 1 hour.|PARU (Postanesthesia Recovery Unit - participants typically remain in PARU for 1 hour)|||mg/kg/h||Standard Deviation|Mean
772568|NCT00727025|Primary|Time to Perform Wound Closure|Time from completion of deep dermal closure to complete closure of wound, either by steri-strip application or by subcuticular suture|intraoperatively|those who completed application of devices intraoperatively||minutes||Standard Deviation|Mean
772569|NCT00727025|Secondary|Patient Postoperative Incisional Comfort|Using a comfort scale from 0-10 with 0 being very uncomfortable and 10 being very comfortable|10 days|||units on a scale||Standard Deviation|Mean
772570|NCT00727025|Primary|Scar Quality at 6 Months Postoperative|Patients used a rating scale with range of 1-9 with 1 being the best scar and 9 being the worst scar. Patients had photos of scars within this range to anchor their choices.|6 months|||units on a scale||Standard Deviation|Mean
772571|NCT00727064|Primary|Area Under the Concentration-time Curve (AUC) of Desvenlafaxine After Single Dose of DVS SR by Metabolizer Status|AUC is drug level over time and measures drug metabolism. Variations in drug metabolism among individuals can be due to differences in genetic expression (phenotype) of Cytochrome P450 (CYP450) enzymes. Enzyme CYP2D6 has 4 metabolizer phenotypes: poor (PM), intermediate (IM), extensive (EM), ultrarapid (UM) metabolizers.|single dose|All participants from sequence groups A and B who received a single dose of venlafaxine ER.||ng*h/mL (90% CI)||90% Confidence Interval|Geometric Mean
772572|NCT00727064|Primary|Maximum Concentration (Cmax) of Desvenlafaxine After Single Dose of Desvenlafaxine Succinate Sustained-Release (DVS SR) by Metabolizer Status|Cmax is a measure of drug metabolism and is presented as least squares geometric mean with 90% Confidence Interval.Variations in drug metabolism among individuals can be due to differences in genetic expression (phenotype) of Cytochrome P450 (CYP450) enzymes. Enzyme CYP2D6 has 4 metabolizer phenotypes: poor (PM), intermediate (IM), extensive (EM), and ultrarapid (UM) metabolizers.|single dose|All participants from sequence groups A and B who received a single dose of venlafaxine ER.||ng/mL (90% CI)||90% Confidence Interval|Geometric Mean
772573|NCT00727064|Primary|Area Under the Concentration-time Curve (AUC) of Desvenlafaxine After Single Dose of VEN ER by Metabolizer Status|AUC is drug level over time and measures drug metabolism. Variations in drug metabolism among individuals can be due to differences in genetic expression (phenotype) of Cytochrome P450 (CYP450) enzymes. Enzyme CYP2D6 has 4 metabolizer phenotypes: poor (PM), intermediate (IM), extensive (EM), ultrarapid (UM) metabolizers.|single dose|All participants from sequence groups A and B who received a single dose of venlafaxine ER.||ng*h/mL (90% CI)||90% Confidence Interval|Geometric Mean
772574|NCT00727064|Primary|Maximum Concentration (Cmax) of Desvenlafaxine After Single Dose of VEN ER by Metabolizer Status|Cmax is a measure of drug metabolism. Variations in drug metabolism among individuals can be due to differences in genetic expression (phenotype) of Cytochrome P450 (CYP450) enzymes. Enzyme CYP2D6 has 4 metabolizer phenotypes: poor (PM), intermediate (IM), extensive (EM), and ultrarapid (UM) metabolizers.|single dose|All participants from sequence groups A and B who received a single dose of venlafaxine ER.||ng/mL (90% CI)||90% Confidence Interval|Geometric Mean
772575|NCT00727064|Primary|Area Under the Concentration-time Curve (AUC) of Venlafaxine After Single Dose of VEN ER by Metabolizer Status|AUC is drug level over time and measures drug metabolism. Variations in drug metabolism among individuals can be due to differences in genetic expression (phenotype) of Cytochrome P450 (CYP450) enzymes. Enzyme CYP2D6 has 4 metabolizer phenotypes: poor (PM), intermediate (IM), extensive (EM), ultrarapid (UM) metabolizers.|single dose|All participants from sequence groups A and B who received a single dose of venlafaxine ER.||ng*h/mL (90% CI)||90% Confidence Interval|Geometric Mean
772576|NCT00727064|Primary|Maximum Concentration (Cmax) of Venlafaxine After Single Dose of Venlafaxine Extended-release (VEN ER) by Metabolizer Status|Cmax is a measure of drug metabolism and presented as least squares geometric mean with 90% Confidence Interval. Variations in drug metabolism among individuals can be due to differences in genetic expression (phenotype) of Cytochrome P450 (CYP450) enzymes. Enzyme CYP2D6 has 4 metabolizer phenotypes: poor (PM), intermediate (IM), extensive (EM), and ultrarapid (UM) metabolizers.|single dose|All participants from sequence groups A and B who received a single dose of venlafaxine ER.||ng/mL (90% CI)||90% Confidence Interval|Geometric Mean
772577|NCT00727090|Secondary|Glasgow Coma Scale|Standardized examination of mental status ranging from 3 (worst) to 15 (best possible)|48 hours||||||
772578|NCT00727090|Other Pre-specified|Change in Serum Sodium From Baseline to 48 Hours||48 hours|||mMol/L||Standard Deviation|Mean
772579|NCT00727090|Other Pre-specified|Change in Serum Sodium From Baseline to 36 Hours||36 hours|||mMol/L||Standard Deviation|Mean
772580|NCT00727090|Other Pre-specified|Change in Serum Sodium From Baseline to 24 Hours||24 hours|||mMol/L||Standard Deviation|Mean
772581|NCT00727090|Other Pre-specified|Change in Serum Sodium From Baseline to 18 Hours||18 hours|||mMol/L||Standard Deviation|Mean
772582|NCT00727090|Other Pre-specified|Change in Serum Sodium From Baseline to 12 Hours||12 hours|||mMol/L||Standard Deviation|Mean
772583|NCT00727090|Secondary|NIH Stroke Scale|Standardized neurologic examination, ranging from 0 (best) to 42 (worst possible).|48 hours||||||
772584|NCT00727090|Primary|Change in Serum Sodium From Baseline to 6 Hours||48 hours|Intention to treat||mMol/L||Standard Deviation|Mean
786186|NCT00833690|Secondary|Serum Urate|From blood sample drawn after taking study drug that day|Visit 06 (Month 6; 180 +/- 7 days after Baseline Visit)|||mg/dL||Standard Deviation|Mean
772585|NCT00727194|Secondary|Change From Baseline to the End of Treatment (16 Weeks) in the Two Most Affected QMG Items for Disease Severity (Individual Test Item: Ptosis)|The QMG scoring system is considered to be an objective evaluation of muscle strength based on quantitative testing of sentinel muscle groups. The MGFA task force has recommended that the QMG score be used in prospective studies of therapy for MG. All individual QMG items are scored 0 to 3, with 3 being the most severe. Negative values imply an improvement in QMG Item Score.|16 weeks|The Investigators selected the 2 most affected items (double vision, ptosis) out of the 13 items in the QMG scoring system for each of their patients based on their clinical evaluation at Baseline. The count is provided when the item was selected as the most affected by the Investigator, for participants who were treated in the respective sequence.||units on a scale||Standard Deviation|Mean
772586|NCT00727194|Secondary|Change From Baseline to the End of Treatment (16 Weeks) in the Two Most Affected QMG Items for Disease Severity (Individual Test Item: Double Vision)|The QMG scoring system is considered to be an objective evaluation of muscle strength based on quantitative testing of sentinel muscle groups. The MGFA task force has recommended that the QMG score be used in prospective studies of therapy for MG. All individual QMG items are scored 0 to 3, with 3 being the most severe. Negative values imply an improvement in QMG Item Score.|16 weeks|The Investigators selected the 2 most affected items (double vision, ptosis) out of the 13 items in the QMG scoring system for each of their patients based on their clinical evaluation at Baseline. The count is provided when the item was selected as the most affected by the Investigator, for participants who were treated in the respective sequence.||units on a scale||Standard Deviation|Mean
772587|NCT00727194|Secondary|Change From Baseline in Respiratory Function Tests to Characterize the Degree of Involvement of Respiratory Muscles.|Change from Baseline in Negative Inspiratory Force. NIF is a measurement of respiratory muscle strength and ventilator reserve. NIF is represented by centimeters of water pressure (cmH2O). A normal NIF measurement is negative 60 cmH2O, or as 100% predicted value.|16 weeks|Comparison of NIF at the Last Visit Between Eculizumab and Placebo Cohorts.||percentage of predicted||Standard Deviation|Mean
772588|NCT00727194|Secondary|Change From Baseline in Respiratory Function Tests to Characterize the Degree of Involvement of Respiratory Muscles.|Change from Baseline in Forced Vital Capacity|16 weeks|Comparison of FVC at the Last Visit Between Eculizumab and Placebo Cohorts.||percentage of predicted||Standard Deviation|Mean
772589|NCT00727194|Secondary|Change From Baseline in the QoL Instrument, SF-36.|The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (physical functioning, role-physical, bodily pain, general health, mental health, role-emotional, social functioning and vitality) as well as psychometrically-based physical and mental health summary measures. It is a generic measure, as opposed to one that targets a specific age, disease or treatment group. The lower the score the more disability; the higher the score the less disability. Norm-based scoring involving a linear T-score transformation method was used so that scores for each of the health domain scales and component summary measures have a mean of 50 and a standard deviation of 10 based on the 1998 US general population. Thus, scores above and below 50 are above and below the average, respectively, in the 1998 US general.|16 weeks|Comparison of SF-36 at the Last Visit Between Eculizumab and Placebo Cohorts.||units on a scale||Standard Deviation|Mean
772590|NCT00727194|Secondary|Change From Baseline in the MG-Activity of Daily Living Profile (MG-ADL)|The MG-ADL is an 8-point questionnaire that focuses on relevant symptoms and functional performance of activities of daily living (ADL) in MG patients. The 8 items of the MG-ADL were derived from symptom-based components of the original 13-item QMG to assess disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item), and gross motor or limb (2 items) impairment related to effects from MG. In this functional status instrument, each response is graded 0 (normal) to 3 (most severe). The range of total MG-ADL score is 0 – 24. MG-ADL was to be performed at every study visit. The recall period for MG-ADL was since the preceding study visit (1 or 2 weeks).|16 weeks|Comparison of MG Activities of Daily Living (Total score) at the Last Visit Between Eculizumab and Placebo Cohorts.||units on a scale||Standard Deviation|Mean
772591|NCT00727194|Secondary|Change From Baseline in the MGFA Post-Intervention Status (PIS)|The MGFA PIS is designed to assess the clinical state of MG patients at any time after treatment of MG is initiated. Change in status categories of Improved, Unchanged, Worse, Exacerbation, and Died of MG was to be assessed and recorded at every visit from Visits 3 to 24 (Weeks 1 to 16). Minimal manifestations were to be assessed at these visits.|16 weeks|||participants|||Number
772592|NCT00727194|Secondary|Mean Change From Baseline in QMG Total Score|The QMG scoring system is considered to be an objective evaluation of muscle strength based on quantitative testing of sentinel muscle groups. The Myasthenia Gravis Foundation of America task force has recommended that the QMG score be used in prospective studies of therapy for MG. The QMG scoring system consists of 13 items. Each item is graded 0 to 3, with 3 being the most severe. The range of total QMG score is 0-39.|16 weeks|||units on a scale||Standard Deviation|Mean
772593|NCT00727194|Primary|Quantitative Myasthenia Gravis (QMG): The Primary Efficacy Endpoint in This Study Was the Percentage of Patients With a 3-point Reduction From Baseline in the QMG Total Score for Disease Severity.|The QMG scoring system is considered to be an objective evaluation of muscle strength based on quantitative testing of sentinel muscle groups. The MGFA task force has recommended that the QMG score be used in prospective studies of therapy for MG.|16 weeks|||percentage of patients|||Number
772594|NCT00727220|Primary|Change in HgBA1c||Baseline and 6 months|||percentage of glycosylated hemoglobin||Standard Deviation|Mean
772595|NCT00727246|Primary|Cognitive Composite Score for Group of Subjects With TBI and Unmatched Healthy Controls|A mean index score created as a composite cognitive performance across domains. Purpose was to serve as a measure of overall cognitive functioning for data analysis. Higher T-scores indicate higher levels of cognitive functioning. Due to the small number of subjects in this study, this second analysis was completed using the same number of subjects in the TBI and control groups, but without matching so that a slightly larger number of subject's data could be utilized. Although analyses were run, due to the very small number of participants in this study, results should be considered with caution.|6 weeks|cognitive composite scores of individuals with a history of TBI as compared to healthy controls 6 weeks after treatment with CDP Choline (1000 mg CDP-Choline 2 x per day for 6 weeks) as compared to those treated with placebo. See note above related to the limited number of subjects in each group.||T-score||95% Confidence Interval|Mean
772596|NCT00727246|Primary|Cognitive Composite Score for Group of Subjects With TBI and Healthy Controls Matched by Age, Education, and Treatment Group.|.A mean index score created as a composite cognitive performance across domains. Purpose was to serve as a measure of overall cognitive functioning for data analysis. A higher T-score indicates a higher level of cognitive function. Due to matching criteria of age range, gender and education level, as well as the small number of subjects with TBI who complete the study (n = 5), matched groups required a reduction to 2 subjects per group for analysis as planned per protocol. Due to the small number of subjects in this study overall, although analyses were run, results should be considered with caution.|6 weeks|A repeated measure ANOVA was completed to evaluate potential differences in cognitive composite scores of subjects with TBI as compared to healthy controls 6 weeks after treatment with CDP Choline (1000 mg CDP-Choline 2 x per day for 6 weeks) as compared to those treated with placebo. Matching criteria and small n for TBI group reduced group sizes.||T-score||95% Confidence Interval|Mean
772597|NCT00727259|Primary|Evaluation of the Satisfaction of the PegPen (PegIntron Preparation and Injection Easiness) Using a Patient Questionnaire Answered at 1 Month and 3 Months|Patient satisfaction for each item on the questionnaires was rated on a scale from 0 (not satisfied) to 7 (very satisfied).|The patient was instructed to answer and return by mail the first self-questionnaire after 1 month of treatment and the second one after 3 months of treatment.|Both patient questionnaires were returned by 940 subjects. However, some items were not rated on the returned questionnaires. The missing data for questionnaire items range from 24 subjects to 72 subjects.||satisfaction rating from 0-7||Standard Deviation|Mean
772598|NCT00733226|Secondary|Effect of OM-85 BV on Cytokine Levels|Cytokine levels were not measured during the trial because of unavailability of laboratory resources.|6 months||||||
772599|NCT00733226|Secondary|Duration of Hospitalization/Per Patient|Over the 12 months of the study we calculated mean duration of hospitalization/per patients.|12 months|||day/per patient||Standard Error|Mean
772600|NCT00733226|Secondary|Number of Hospitalizations|"During the study period of 12 months all hospitalizations for wheezing attacks were recorded.
Over the 12 months of the trial mean number of hospitalizations/per patients were calculated.
This outcome was calculated by dividing cumulative number of hospitalizations by number of participants in each group over the 12 months of the trial."|12 months|||hospitalization/per patient||Standard Error|Mean
772601|NCT00733226|Secondary|Number of Wheezing Attacks That Required Systemic Steroid Therapy|"All the wheezing attacks which were enough severe to require systemic steroid therapy were recorded over the 12 months of the study.
At the and of the study period, number of wheezing attacks that required systemic steroid therapy/per patients were calculated. This outcome was calculated by dividing cumulative number of wheezing attacks that required systemic steroid therapy by number of participants in each group."|12 months|||wheezing attacks/per patient||Standard Error|Mean
772602|NCT00733226|Secondary|Number of Common Cold|"All the common colds were recorded during the 12 months of the study. At the and of the study period the two groups were compared according to the number of common-cold/per patient over the 12 months of the trial.
This outcome was calculated by dividing cumulative number of common colds by number of participants in each group over the 12 months of the trial."|12 months|||common cold/per patients||Standard Error|Mean
772603|NCT00733226|Secondary|Mean Duration (in Day) of Wheezing Attacks Per Patient|Over the 12 months of the study we calculated mean duration of each wheezing attacks/per patients.This measure was calculated separately for each participants by dividing duration of wheezing attacks to number of wheezing attacks.|12 months|||day/per patient||Standard Error|Mean
772604|NCT00733226|Primary|Mean Rate of Wheezing Attacks|Acute wheezing attack was defined as episode of progressive increase in shortness of breath, cough, wheezing, retraction of the chest and chest tightness, or combination of these symptoms. When wheezing attack occured it was Over the 12 months of the study mean number (rate) of wheezing attacks/per patient was calculated and compared with placebo. This outcome measure was calculated by dividing cumulative wheezing attacks to number of participants in each group.|12 months|||wheezing attacks/per patient||Standard Error|Mean
772605|NCT00733278|Secondary|Visibility Within the Vagina of IUD Strings at All Times.||At 3 days, 2 weeks and 6 weeks postpartum|||participants|||Number
772606|NCT00733278|Primary|Successful Retention of IUD||6 weeks|||participants|||Number
772607|NCT00733291|Primary|Total Corneal Staining Type|Total corneal staining type was assessed by the investigator for each of 5 regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. Corneal staining type was recorded on a 5-point scale for each region: 0-none; 1-micropunctate; 2-macropunctate; 3-coalesced macropunctate; 4-patch (>/= 1mm). The five regions were summed.|After 2 hours of wear|This reporting group is based on the number of subjects in the evaluable population for the indicated lens as treated.||Units on a scale||Standard Deviation|Mean
772608|NCT00733291|Secondary|Ocular Redness|"Ocular redness was recorded by the participant on a questionnaire using a 5-point scale. Participant completed the sentence, Right now my eyes look... with one of the following responses: 1-very white; 2-white; 3-neither white nor red; 4-red; 5-very red."|After two hours of wear|This reporting group is based on the number of subjects in the evaluable population for the indicated lens as treated.||Units on a scale||Standard Deviation|Mean
772609|NCT00733291|Primary|Average Corneal Staining Area|Percentage corneal staining was assessed by the investigator for each of five regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. Percentage corneal staining area was recorded in increments of ten, and the percentages of the five regions were averaged together.|After 2 hours of wear|This reporting group is based on the number of subjects in the evaluable population for the indicated lens as treated.||Percentage area of cornea||Standard Deviation|Mean
772610|NCT00733291|Secondary|Ocular Comfort|"Ocular comfort was recorded by the participant on a questionnaire using a 5-point scale. Participant completed the sentence, Right now my eyes feel... with one of the following responses: 1-very comfortable; 2-comfortable; 3-neither comfortable nor uncomfortable; 4-uncomfortable; 5-very uncomfortable."|After 2 hours of wear|This reporting group is based on the number of subjects in the evaluable population for the indicated lens as treated.||Units on a scale||Standard Deviation|Mean
772988|NCT00734994|Primary|Safety and Tolerability|Number of patient treatments stopped due to safety concerns or treatment intolerability. All events below are grade 1/2 toxicity. No grade 3-5 toxicity was observed.|During Treatment Phase average 6 weeks|||Grade 1/2 event count (no grade 3+)|Participants||Number
772611|NCT00733330|Secondary|To Compare 6 Minute Walk Test Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|This score records the total distance walked (measured in feet) in 6 minutes (this time includes any time that the subject needs to stop and rest).|6 months|There were 13 missing outcomes, 1 protocol violation, 1 consent withdrawal, and 2 Lost to Follow Up for this endpoint.||Feet||Standard Deviation|Mean
772612|NCT00733330|Secondary|To Compare 6 Minute Walk Test Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|This score records the total distance walked (measured in feet) in 6 minutes (this time includes any time that the subject needs to stop and rest).|12 weeks|There were 32 missing outcomes, 1 protocol violation, 1 consent withdrawal, and 2 Lost to Follow Up for this endpoint.||Feet||Standard Deviation|Mean
772613|NCT00733330|Secondary|To Compare 6 Minute Walk Test Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|This score records the total distance walked (measured in feet) in 6 minutes (this time includes any time that the subject needs to stop and rest).|8 weeks|There were 20 missing outcomes, 1 protocol violation, 1 consent withdrawal, and 1 Lost to Follow Up for this endpoint.||Feet||Standard Deviation|Mean
772614|NCT00733330|Secondary|To Compare 6 Minute Walk Test Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|This score records the total distance walked (measured in feet) in 6 minutes (this time includes any time that the subject needs to stop and rest).|4 weeks|There were 21 missing outcomes and 1 consent withdrawal for this endpoint.||Feet||Standard Deviation|Mean
772615|NCT00733330|Secondary|To Compare 6 Minute Walk Test Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|This score records the total distance walked (measured in feet) in 6 minutes (this time includes any time that the subject needs to stop and rest). Pre-operatively, the subject must complete both a practice walk and a test walk.|pre-op|There were 5 missing outcomes for this endpoint.||Feet||Standard Deviation|Mean
772616|NCT00733330|Secondary|To Compare the Change From 6-12 Weeks & 5 Years on Long Leg Alignment.|An independent radiographer will observe and record alignment|5 years|The study was terminated before completion due to business purposes, therefore no radiographs were analyzed and there are no results for this outcome.|||||
772617|NCT00733330|Secondary|To Compare Interface Radiographic Appearance Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|An independent radiographer will observe and record alignment.|5 years|The study was terminated before completion due to business purposes, therefore no radiographs were analyzed and there are no results for this outcome.|||||
772618|NCT00733330|Secondary|To Compare VAS Pain Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|A 100-mm visual analog scale (VAS) was used to assess pain after the subject completes the 6-minute walk test. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their knee joint.|6 months|There were 12 missing outcomes, 1 protocol violation, 1 consent withdrawal, and 2 Lost to Follow Up for this endpoint.||millimeters||Standard Deviation|Mean
772619|NCT00733330|Secondary|To Compare VAS Pain Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|A 100-mm visual analog scale (VAS) was used to assess pain after the subject completes the 6-minute walk test. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their knee joint.|12 Weeks|There were 37 missing outcomes, 1 protocol violation, 1 consent withdrawal, and 2 Lost to Follow Up for this endpoint.||millimeters||Standard Deviation|Mean
772620|NCT00733330|Secondary|To Compare VAS Pain Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|A 100-mm visual analog scale (VAS) was used to assess pain after the subject completes the 6-minute walk test. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their knee joint.|8 Weeks|There were 26 missing outcomes, 1 protocol violation, 1 consent withdrawal, and 1 Lost to Follow up for this endpoint.||millimeters||Standard Deviation|Mean
772621|NCT00733330|Secondary|To Compare VAS Pain Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|A 100-mm visual analog scale (VAS) was used to assess pain after the subject completes the 6-minute walk test. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their knee joint.|4 Weeks|There were 23 missing outcomes and 1 Consent Withdrawal for this endpoint.||millimeters||Standard Deviation|Mean
772622|NCT00733330|Secondary|To Compare VAS Pain Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|A 100-mm visual analog scale (VAS) was used to assess pain after the subject completes the 6-minute walk test. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their knee joint.|pre-op|There were 3 missing outcomes for this endpoint.||millimeters||Standard Deviation|Mean
772623|NCT00733330|Secondary|To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|WOMAC is a patient reported outcome (PRO) that evaluates the condition of subject's with knee osteoarthritis, and includes pain (score range 0-20), stiffness (score range 0-8), and physical function (score range 0-68) of the joint, where a lower score indicates a better outcome. The WOMAC total score is a combination of the three domains (pain, stiffness, and physical function) with a range of 0-96.|5 years|The study was terminated early for business reasons therefore there are no outcomes for this endpoint.|||||
772636|NCT00733330|Secondary|To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|8 Weeks|There were 19 missing outcomes, 1 consent withdrawal, 1 protocol violation, and 1 Lost to Follow Up for this endpoint.||points||Standard Deviation|Mean
772624|NCT00733330|Secondary|To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|WOMAC is a patient reported outcome (PRO) that evaluates the condition of subject's with knee osteoarthritis, and includes pain (score range 0-20), stiffness (score range 0-8), and physical function (score range 0-68) of the joint, where a lower score indicates a better outcome. The WOMAC total score is a combination of the three domains (pain, stiffness, and physical function) with a range of 0-96.|2 years|There were 44 missing outcomes, 3 Protocol Violations, 1 Consent Withdrawal, and 2 Lost to Follow Up for this endpoint.||points||Standard Deviation|Mean
772625|NCT00733330|Secondary|To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|WOMAC is a patient reported outcome (PRO) that evaluates the condition of subject's with knee osteoarthritis, and includes pain (score range 0-20), stiffness (score range 0-8), and physical function (score range 0-68) of the joint, where a lower score indicates a better outcome. The WOMAC total score is a combination of the three domains (pain, stiffness, and physical function) with a range of 0-96.|1 year|There were 25 missing outcomes, 3 protocol violations, 1 consent withdrawal, and 2 Lost to Follow Up for this endpoint.||points||Standard Deviation|Mean
772626|NCT00733330|Secondary|To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|WOMAC is a patient reported outcome (PRO) that evaluates the condition of subject's with knee osteoarthritis, and includes pain (score range 0-20), stiffness (score range 0-8), and physical function (score range 0-68) of the joint, where a lower score indicates a better outcome. The WOMAC total score is a combination of the three domains (pain, stiffness, and physical function) with a range of 0-96.|6 months|There were 16 missing outcomes, 1 protocol violation, 1 consent withdrawal, and 2 Lost to Follow Up for this endpoint.||points||Standard Deviation|Mean
772627|NCT00733330|Secondary|To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|WOMAC is a patient reported outcome (PRO) that evaluates the condition of subject's with knee osteoarthritis, and includes pain (score range 0-20), stiffness (score range 0-8), and physical function (score range 0-68) of the joint, where a lower score indicates a better outcome. The WOMAC total score is a combination of the three domains (pain, stiffness, and physical function) with a range of 0-96.|12 weeks|There were 36 missing outcomes, 1 protocol violation, 1 consent withdrawal, and 2 Lost to Follow Up for this endpoint.||points||Standard Deviation|Mean
772628|NCT00733330|Secondary|To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|WOMAC is a patient reported outcome (PRO) that evaluates the condition of subject's with knee osteoarthritis, and includes pain (score range 0-20), stiffness (score range 0-8), and physical function (score range 0-68) of the joint, where a lower score indicates a better outcome. The WOMAC total score is a combination of the three domains (pain, stiffness, and physical function) with a range of 0-96.|8 weeks|There were 22 missing outcomes, 1 protocol violation, 1 consent withdrawal, and 1 Lost to Follow Up for this endpoint.||points||Standard Deviation|Mean
772629|NCT00733330|Secondary|To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|WOMAC is a patient reported outcome (PRO) that evaluates the condition of subject's with knee osteoarthritis, and includes pain (score range 0-20), stiffness (score range 0-8), and physical function (score range 0-68) of the joint, where a lower score indicates a better outcome. The WOMAC total score is a combination of the three domains (pain, stiffness, and physical function) with a range of 0-96.|4 Weeks|There were 21 missing outcomes and 1 consent withdrawal for this endpoint.||points||Standard Deviation|Mean
772630|NCT00733330|Secondary|To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|WOMAC is a patient reported outcome (PRO) that evaluates the condition of subject's with knee osteoarthritis, and includes pain (score range 0-20), stiffness (score range 0-8), and physical function (score range 0-68) of the joint, where a lower score indicates a better outcome. The WOMAC total score is a combination of the three domains (pain, stiffness, and physical function) with a range of 0-96.|pre-op|There were 4 missing outcomes for this endpoint.||points||Standard Deviation|Mean
772631|NCT00733330|Secondary|To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|5 years|The study was terminated before completion due to business purposes, therefore there are no results for this outcome.|||||
772632|NCT00733330|Secondary|To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|2 years|There were 41 missing outcomes, 3 protocol violations, 1 consent withdrawal, and 2 Lost to Follow Up for this endpoint.||points||Standard Deviation|Mean
772633|NCT00733330|Secondary|To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|1 Year|There were 21 missing outcomes, 3 protocol violations, 1 consent withdrawal, and 2 Lost to Follow up for this endpoint.||points||Standard Deviation|Mean
772634|NCT00733330|Secondary|To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|6 Months|There were 10 missing outcomes, 1 protocol violation, 1 consent withdrawal and 2 Lost to Follow up for this endpoint.||points||Standard Deviation|Mean
772635|NCT00733330|Secondary|To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|12 Weeks|There were 33 missing outcomes, 1 protocol violation, 1 consent withdrawal, and 2 Lost to Follow up for this endpoint.||points||Standard Deviation|Mean
772989|NCT00734994|Secondary|Median Recurrence Free-survival|Time to first recurrence of cancer in the bladder.|Median follow-up 3.18 years|Entire cohort||Months||95% Confidence Interval|Median
772637|NCT00733330|Secondary|To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|4 Weeks|There were 19 missing outcomes and 1 consent withdrawal for this outcome.||points||Standard Deviation|Mean
772638|NCT00733330|Secondary|To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|pre-op|There were 2 missing outcomes for this endpoint.||points||Standard Deviation|Mean
772639|NCT00733330|Secondary|To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|5 years|The study was terminated before completion due to business purposes, therefore no outcomes are available for this endpoint.|||||
772640|NCT00733330|Secondary|To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|2 years|There were 41 missing outcomes, 1 consent withdrawal, 2 Lost to Follow Up, and 3 protocol violations for this endpoint.||points||Standard Deviation|Mean
772641|NCT00733330|Secondary|To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|1 year|There were 22 missing outcomes, 1 consent withdrawal, 2 Lost to Follow Up, and 3 protocol violations for this endpoint.||points||Standard Deviation|Mean
772642|NCT00733330|Secondary|To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|6 Months|There were 10 missing outcomes, 1 consent withdrawal, 2 Lost to Follow Up and 1 protocol violation for this endpoint.||points||Standard Deviation|Mean
772643|NCT00733330|Secondary|To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|12 Weeks|There were 32 missing outcomes, 1 consent withdrawal, 2 Lost to Follow Up and 1 protocol violation for this endpoint.||points||Standard Deviation|Mean
772644|NCT00733330|Secondary|To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|8 Weeks|There were 19 missing outcomes, 1 consent withdrawal, 1 Lost to Follow Up and 1 protocol violation for this endpoint.||points||Standard Deviation|Mean
772645|NCT00733330|Secondary|To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|The American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|4 Weeks|There were 19 missing outcomes and 1 consent withdrawal for this endpoint.||points||Standard Deviation|Mean
772646|NCT00733330|Secondary|To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|Pre-op|Of the 84 subjects who received surgery, there were 3 missing outcomes for this endpoint.||points||Standard Deviation|Mean
772647|NCT00733330|Secondary|To Compare the Number of Optimal Implantations Achieved From Pre-op to 6-12 Weeks Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|Achieved alignment results will be measured on post-op X-rays taken at the time the subject has achieved full extension.|4 - 12 Weeks|The study was terminated before completion due to business purposes, therefore no radiographs were analyzed and there are no results for this outcome.|||||
772648|NCT00733330|Secondary|To Compare the Proportion of Procedures That Fall Within a Satisfactory Alignment Window Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|An independent radiographic observer will determine and record alignment.|operative|The study was terminated before completion due to business purposes, therefore no radiographs were analyzed and there are no results for this outcome.|||||
772649|NCT00733330|Primary|To Compare the Precision of the Long Leg Alignment Between the Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|Alignment will be measured on long leg weight bearing X-rays performed when the subject has full leg extension (+/-5 degrees)|6 - 12 Weeks|The study was terminated before completion due to business purposes, therefore no radiographs were analyzed.|||||
772650|NCT00733369|Secondary|To Compare the Change in EQ-5D3L VAS Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|5 years|Study terminated early due to slow recruitment rate. 5 Year data not available.|||Participants||
772713|NCT00733421|Secondary|Summary of Pain Scores, Day 1-7 of Visual Analogue Scale Grading of Pain|VAS score 1-10 1=no pain 10 = worst possible pain, summary variable day 1-7; 7 - 70|The first 7 days after surgery, during study pain medication|||scores on a scale||Standard Deviation|Mean
772651|NCT00733369|Secondary|To Compare the Change in EQ-5D3L VAS Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|2 years|106 knees enrolled, 15 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 4 Revisions (4Inv & 4Contr)+ 3 Lost to follow up (2Inv & 1Contr)}||Points|Participants|Standard Deviation|Mean
772652|NCT00733369|Secondary|To Compare the Change in EQ-5D3L VAS Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|1 year|106 knees enrolled, 13 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 2 Lost to follow up (1Inv & 1Contr) + 3 Missing outcome (0Inv & 3Contr)}||Points|Participants|Standard Deviation|Mean
772653|NCT00733369|Secondary|To Compare the Change in EQ-5D3L VAS Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|3 - 6 months|106 knees enrolled, 9 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 1 Lost to follow up (1Inv & 0Contr)}||Points|Participants|Standard Deviation|Mean
772654|NCT00733369|Secondary|To Compare the Change in EQ-5D3L Anxiety/Depression Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|2 years|106 knees enrolled, 15 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + + 4 Revisions (1Inv & 3Contr) + 3 Lost to follow up (2Inv & 1Contr)}||Points|Participants|Standard Deviation|Mean
772655|NCT00733369|Secondary|To Compare the Change in EQ-5D3L Anxiety/Depression Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|1 year|106 knees enrolled, 11 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 2 Lost to follow up (1Inv & 1Contr) + 1 Missing outcome (0Inv & 1Contr)}||Points|Participants|Standard Deviation|Mean
772656|NCT00733369|Secondary|To Compare the Change in EQ-5D3L Anxiety/Depression Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|3 - 6 months|106 knees enrolled, 9 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 1 Lost to follow up (1Inv & 0Contr)}||Points|Participants|Standard Deviation|Mean
772657|NCT00733369|Secondary|To Compare the Change in EQ-5D3L Pain/Discomfort Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|5 years|Study terminated early due to slow recruitment rate. 5 Year data not available.|||Participants||
772658|NCT00733369|Secondary|To Compare the EQ-5D3L Pain/Discomfort Score Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|2 years|106 knees enrolled, 15 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 4 Revisions (1Inv & 3Contr) + 3 Lost to follow up (2Inv & 1Contr)}||Points|Participants|Standard Deviation|Mean
772659|NCT00733369|Secondary|To Compare the EQ-5D3L Pain/Discomfort Score Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|1 year|106 knees enrolled, 11 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 2 Lost to follow up (1Inv & 1Contr) + 1 Missing outcome (0Inv & 1Contr)}||Points|Participants|Standard Deviation|Mean
772660|NCT00733369|Secondary|To Compare the EQ-5D3L Pain/Discomfort Score Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|3 - 6 months|106 knees enrolled, 9 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 1 Lost to follow up (1Inv & 0Contr)}||Points|Participants|Standard Deviation|Mean
772661|NCT00733369|Secondary|To Compare the Change in EQ-5D3L Usual Activities Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|5 years|Study terminated early due to slow recruitment rate. 5 Year data not available.|||Participants||
772662|NCT00733369|Secondary|To Compare the Change in EQ-5D3L Usual Activities Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|2 years|106 knees enrolled, 15 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 4 Revisions (1Inv & 3Contr) + 3 Lost to follow up (2Inv & 1Contr)}||Points|Participants|Standard Deviation|Mean
772663|NCT00733369|Secondary|To Compare the Change in EQ-5D3L Usual Activities Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|1 year|106 knees enrolled, 11 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 2 Lost to follow up (1Inv & 1Contr) + 1 Missing outcome (0Inv & 1Contr)}||Points|Participants|Standard Deviation|Mean
772664|NCT00733369|Secondary|To Compare the Change in EQ-5D3L Usual Activities Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|3 - 6 months|106 knees enrolled, 9 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 1 Lost to follow up (1Inv & 0Contr)}||Points|Participants|Standard Deviation|Mean
772665|NCT00733369|Secondary|To Compare the Change in EQ-5D3L Self-Care Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|5 years|Study terminated early due to slow recruitment rate. 5 Year data not available.|||Participants||
772666|NCT00733369|Secondary|To Compare the Change in EQ-5D3L Self-Care Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|2 years|106 enrolled knees, 15 of which excluded from analysis due to: {0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 4 Revisions (1 Inv & 3 Contr) + 3 Lost to follow up (2 Inv & 1 Contr)}||Points|Participants|Standard Deviation|Mean
772667|NCT00733369|Secondary|To Compare the Change in EQ-5D3L Self-Care Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|1 year|106 enrolled knees, 11 of which excluded from analysis due to: {0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 2 Lost to follow up (1 Inv & 1 Contr) + 1 Missing outcome ( 0 Inv & 1 Contr)}||Points|Participants|Standard Deviation|Mean
772668|NCT00733369|Secondary|To Compare the Change in EQ-5D3L Self-Care Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|3 - 6 months|106 knees enrolled, 9 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 1 Lost to follow up (1Inv & 0Contr)}||Points|Participants|Standard Deviation|Mean
772669|NCT00733369|Secondary|To Compare the Change in EQ-5D3L MOBILITY Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|5 years|Study terminated early to slow recruitment rate. 5 Year data not available.|||Participants||
772670|NCT00733369|Secondary|To Compare the Change in EQ-5D3L MOBILITY Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|2 years|106 knees enrolled, 15 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 4 Revisions (1Inv & 3Contr) + 3 Lost to follow up (2Inv & 1Contr)}||Points|Participants|Standard Deviation|Mean
772671|NCT00733369|Secondary|To Compare the Change in EQ-5D3L MOBILITY Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|1 year|106 knees enrolled, 11 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 2 Lost to follow up (1Inv & 1Contr) + 1 Missing outcome (0Inv & 1Contr)}||Points|Participants|Standard Deviation|Mean
772672|NCT00733369|Secondary|To Compare the Change in EQ-5D3L MOBILITY Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|3 - 6 months|106 knees enrolled, 9 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 1 Lost to follow up (1Inv & 0Contr)}||Points|Participants|Standard Deviation|Mean
772673|NCT00733369|Secondary|To Compare the Change in Oxford Knee Score (OKS) From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|5 years|Study terminated early due to a slow recruitment rate. 5 Year data not available.|||Participants||
772674|NCT00733369|Secondary|To Compare the Change in Oxford Knee Score (OKS) From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|2 years|106 knees enrolled, 17 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 4 Revisions (1Inv & 3Contr) + 3 Lost to follow up (2Inv & 1Contr) + 2 Missing outcome (0Inv & 2Contr)}||Points|Participants|Standard Deviation|Mean
772675|NCT00733369|Secondary|To Compare the Change in Oxford Knee Score (OKS) From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|1 year|106 knees enrolled, 12 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 2 Lost to follow up (1Inv & 1Contr) + 2 Missing outcome (1Inv & 1Contr)}||Points|Participants|Standard Deviation|Mean
772676|NCT00733369|Secondary|To Compare the Change in Oxford Knee Score (OKS) From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|3 - 6 months|106 knees enrolled, 10 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 1 Lost to follow up (1Inv & 0Contr) + 1 Missing outcome (0Inv & 1Contr)}||Points|Participants|Standard Deviation|Mean
772677|NCT00733369|Secondary|To Compare the Change in American Knee Society (AKS) Function Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|American Knee Society (AKS) function score is a 0-100 point score (where 100 indicates excellent knee function) that evaluates the affected knee.|5 years|Study terminated early due to a slow recruitment rate. 5 Year data not available.|||Participants||
772678|NCT00733369|Secondary|To Compare the Change in American Knee Society (AKS) Function Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|American Knee Society (AKS) function score is a 0-100 point score (where 100 indicates excellent knee function) that evaluates the affected knee.|2 years|106 knees enrolled, 16 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 4 Revisions (1Inv & 3Contr) + 3 Lost to follow up (2Inv & 1Contr) + 1 Missing outcome (0Inv & 1Contr)}||Points|Participants|Standard Deviation|Mean
772679|NCT00733369|Secondary|To Compare the Change in American Knee Society (AKS) Function Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|American Knee Society (AKS) function score is a 0-100 point score (where 100 indicates excellent knee function) that evaluates the affected knee.|1 year|106 knees enrolled, 11 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 2 Lost to follow up (1Inv & 1Contr) + 1 Missing outcome (1Inv & 0Contr)}||Points|Participants|Standard Deviation|Mean
772714|NCT00733421|Primary|Number of Patients Requiring Rescue Medication|Number of patients requiring any further pain medication|7 day study period|||patients|||Number
772680|NCT00733369|Secondary|To Compare the Change in American Knee Society (AKS) Function Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|American Knee Society (AKS) function score is a 0-100 point score (where 100 indicates excellent knee function) that evaluates the affected knee.|3 - 6 months|106 knees enrolled, 10 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 1 Lost to follow up (1Inv & 0Contr) + 1 Missing outcome (1Inv & 0Contr)}||Points|Participants|Standard Deviation|Mean
772681|NCT00733369|Secondary|To Compare the Change in American Knee Society (AKS) Knee Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|5 years|Study terminated early due to a slow recruitment rate. 5 year data not available.|||Participants||
772682|NCT00733369|Secondary|To Compare the Change in American Knee Society (AKS) Knee Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|2 years|106 enrolled knees, 18 knees excluded from analysis due to: {0 Deaths + 8 Protocol Violations (4 Inv, 4 Contr) + 4 revisions (1 Inv, 1 Contr) + 3 Lost to follow up (2 Inv, 1 Contr) + 3 missing outcome (0 Inv, 3 Cntr)}||Points|Participants|Standard Deviation|Mean
772683|NCT00733369|Secondary|To Compare the Change in American Knee Society (AKS) Knee Score From Pre-Op to 1 Year Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|1 year|106 enrolled knees, 11 knees excluded from analysis due to: {0 Deaths + 8 Protocol Violations (4 Inv, 4 Contr) + 2 lost to follow up (1 Inv, 1 Contr) + 1 missing outcome (1 Inv, 0 Contr) }||Points|Participants|Standard Deviation|Mean
772684|NCT00733369|Secondary|To Compare the Change in American Knee Society (AKS) Knee Score From Pre-Op to 3 to 6 Months Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|3 - 6 months|106 knees enrolled, 10 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 1 Lost to follow up (1Inv & 0Contr) + 1 Missing outcome (1Inv & 0Contr)}||Points|Participants|Standard Deviation|Mean
772685|NCT00733369|Secondary|To Compare the Change in KOOS QOL (Quality of Life) Score From Pre-Op to 5 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|5 years|Study terminated early due to slow recruitment rate. 5 Year data not available.|||Participants||
772686|NCT00733369|Secondary|To Compare the Change in KOOS QOL (Quality of Life) Score From Pre-Op to 2 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|2 years|106 knees enrolled, 16 of which excluded from analysis due to: {0 Deaths + 8 Protocol Violations (4 Inv & 4 Contr) + 4 Revisions (1 Inv & 3 Contr) + 3 Lost to follow up (2 Inv & 1 Contr) + 1 Missing outcome (1 Inv & 0 Contr)}||Points|Participants|Standard Deviation|Mean
772687|NCT00733369|Secondary|To Compare the Change in KOOS QOL (Quality of Life) Score From Pre-Op to 1 Year Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|1 year|106 enrolled knees, 13 of which excluded from the analysis due to:{0 Deaths+ 8 Protocol Violations (4 Inv & 4 Contr)+ 2 Lost to follow up (1 Inv & 1 Contr) + 3 Missing outcome (0 Inv & 3 Contr)}||Points|Participants|Standard Deviation|Mean
772688|NCT00733369|Secondary|To Compare the Change in KOOS QOL (Quality of Life) Score From Pre-Op to 3 to 6 Months Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|3-6 months|106 knees enrolled, 11 of which excluded from analysis due to:{0 deaths + 8 Protocol Violations + 1 Lost to follow up (1Inv & 0Contr) + 2 Missing outcome (1Inv & 1Contr)}||Points|Participants|Standard Deviation|Mean
772689|NCT00733369|Secondary|To Compare the Change in KOOS SPORTS and RECREATION Score From Pre-Op to 5 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|5 years|Study terminated early due to slow recruitment rate, 5 year data not available.|||Participants||
772728|NCT00733954|Secondary|Number of Participants With Tolerability Assessments Resulting in Adverse Events From Baseline to Two Weeks Post Treatment|Number of Participants with Tolerability assessments (Pruritus, Telangiectasias, Stinging/Burning, Skin atrophy, Folliculitis) resulting in adverse events from Baseline to two weeks post treatment (week 6 for clobetasol propionate spray and week 4 for clobetasol propionate ointment)|Baseline and Week 4 and Baseline and Week 6|Safety||Participants|||Number
772690|NCT00733369|Secondary|To Compare the Change in KOOS SPORTS and RECREATION Score From Pre-Op to 2 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|2 years|106 enrolled knees, 16 of which excluded from analysis due to:{0 Deaths+8 Protocol Violations (4 Inv & 4 Contr)+ 4 Revisions (1 Inv & 3 Contr) + 3 Lost to follow up (2 Inv & 1 Contr) + 1 Missing outcome (1 Inv & 0 Contr)}||Points|Participants|Standard Deviation|Mean
772691|NCT00733369|Secondary|To Compare the Change in KOOS SPORTS and RECREATION Score From Pre-Op to 1 Year Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|1 year|106 enrolled knees, 13 of which excluded from analysis due to:{0 Deaths+8 Protocol Violations (4 Inv & 4 Contr)+ 2 Lost to follow up (1 Inv & 1 Contr) + 3 Missing outcome (0 Inv & 3 Contr)}||Points|Participants|Standard Deviation|Mean
772692|NCT00733369|Secondary|To Compare the Change in KOOS SPORTS and RECREATION Score From Pre-Op to 3 to 6 Months Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|3-6 months|106 knees enrolled, 11 of which excluded from analysis due to: {0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 1 Lost to follow up (1Inv & 0Contr) + 2 Missing outcome (1Inv & 1Contr)}||Points|Participants|Standard Deviation|Mean
772693|NCT00733369|Secondary|To Compare the Change in KOOS ADL (Activities of Daily Living) Score From Pre-Op to 5 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|5 years|Study terminated early due to a slow recruitment rate.|||Participants||
772694|NCT00733369|Secondary|To Compare the Change in KOOS ADL (Activities of Daily Living) Score From Pre-Op to 2 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|2 years|106 enrolled knees, 15 of which excluded from the analysis due to:{0 Deaths+8 Protocol Violations (4 Inv & 4 Contr)+ 4 Revisions (1 Inv & 3 Contr) + 3 Lost to follow up (2 Inv & 1 Contr)}||Points|Participants|Standard Deviation|Mean
772695|NCT00733369|Secondary|To Compare the Change in KOOS ADL (Activities of Daily Living) Score From Pre-Op to 1 Year Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|1 year|106 enrolled knees, 11 of which excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4 Inv & 4 Contr)+ 2 Lost to follow up (1 Inv & 1 Contr) + 1 Missing outcome (0 Inv & 1 Contr)}||Points|Participants|Standard Deviation|Mean
772696|NCT00733369|Secondary|To Compare the Change in KOOS ADL (Activities of Daily Living) Score From Pre-Op to 3 to 6 Months Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|3-6 months|106 Enrolled knees, 11 of which excluded from analysis due to:{0 Deaths+8 Protocol Violations(4Inv & 4Contr)+1 Lost to follow up(1Inv & 0Contr)+2 Missing outcome(1Inv & 1Contr)}||Points|Participants|Standard Deviation|Mean
772697|NCT00733369|Secondary|To Compare the Change in KOOS Symptoms Score From Pre-Op to 5 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|5 years|This study was terminated early due to a slow recruitment rate. 5 year data not available.|||Participants||
772698|NCT00733369|Secondary|To Compare the Change in KOOS Symptoms Score From Pre-Op to 2 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|2 years|106 enrolled knees, 15 of which excluded from the analysis due to:{0 Deaths+8 Protocol Violations (4 Inv & 4 Contr)+ 4 Revisions (1 Inv & 1 Contr)+ 3 Lost to follow up (2 Inv & 1 Contr)}||Points|Participants|Standard Deviation|Mean
786187|NCT00833690|Secondary|Serum Urate|From blood sample drawn before taking study drug that day|Visit 05 (Week 12; 84 +/- 7 days after Baseline Visit)|||mg/dL||Standard Deviation|Mean
772699|NCT00733369|Secondary|To Compare the Change in KOOS Symptoms Score From Pre-Op to 1 Year Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|1 year|106 enrolled knees, 11 of which excluded from the analysis due to:{0 Deaths+8 Protocol Violations (4 Inv & 4 Contr)+ 2 Lost to follow up (1 Inv & 1 Contr) + 1 Missing outcome (0 Inv & 1 Contr)}||Points|Participants|Standard Deviation|Mean
772700|NCT00733369|Secondary|To Compare the Change in KOOS Symptoms Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|3-6 months|106 Enrolled knees, 11 of which excluded from analysis due to:{0 Deaths+8 Protocol Violations(4Inv & 4Contr)+1 Lost to follow up(1Inv & 0Contr)+2 Missing outcome(1Inv & 1Contr)}||Points|Participants|Standard Deviation|Mean
772701|NCT00733369|Secondary|To Compare the Change in KOOS Pain Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|5 years|This study has been terminated early, therefore the 5 year data was not collected.|||Participants||
772702|NCT00733369|Secondary|To Compare the Change in KOOS Pain Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|2 years|106 enrolled knees, 15 of which excluded from analysis due to:{0 Deaths + 8 Protocol Violation (4 Inv, 4 Contr) + 4 Revisions (1 Inv, 3 Contr) + 3 Lost to follow up (2 Inv, 1 Contr)}||Points|Participants|Standard Deviation|Mean
772703|NCT00733369|Secondary|To Compare the Change in KOOS Pain Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|1 year|106 enrolled knees, 11 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (Bilaterals accrued at site where bilaterals are not allowed, used 1st knee operated upon: 4 investigational&4control)+ 2 lost to follow up (1 Inv, 1 Contr)+ 1 missing outcome (0Inv, 1 Contr)}||Points|Participants|Standard Deviation|Mean
772704|NCT00733369|Secondary|To Compare the Change in KOOS Pain Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|3-6 months|106 Enrolled knees, 11 of which excluded from analysis due to:{0 Deaths+8 Protocol Violations(4Inv & 4Contr)+1 Lost to follow up(1Inv & 0Contr)+2 Missing outcome(1Inv & 1Contr)}||Points|Participants|Standard Deviation|Mean
772705|NCT00733369|Primary|Change From Pre-op to 1 Year Range of Motion.|Range of motion is knee flexion (how far the patient can bend their knee) minus knee extension (how far the patient can straighten their knee). The result of this subtraction is the range of motion (bending and straightening) for that knee.|1 year|106 enrolled knees, 11 of which excluded from the analysis due to:{0 Deaths + 8 Protocol Violations(bilaterals accrued at site where bilateral not allowed, used first knee operated upon: 4 investigational &4 control) + 2 lost to follow up (1 Inv & 1 Contr) + 1 missing outcome (1 Inv & 0 Contr)}||Degrees|Participants|Standard Deviation|Mean
772706|NCT00733421|Secondary|Patient Assessed Quality of Life|Quality of Life evaluated by grading on a Visual Analogue Scale in the written questionnaireisual analogue scale grading 0-100; 0 death and 100 perfect quality of life|At 16-week post surgery follow-up|||score on a scale||Standard Deviation|Mean
772707|NCT00733421|Secondary|Patient Assessed Overall Satisfaction With Surgery/Outcome|overall satisfaction with outcome, patients assessed satisfaction with the surgical procedure; satisfied, neutral or unsatisfied, written questionnaire.|16 weeks|||Patients.|||Number
772708|NCT00733421|Secondary|Satisfaction With Pain Medication|satisfied or unsatisfied with study medication, assessed by patient in questionnaire|during the first 20 days after surgery, 1st outpatient clinic visit|||patients|||Number
772709|NCT00733421|Secondary|Wound Healing|healing process assessed by a blinded physician during the final outpatient clinic visit assessment graded; Good/neutral/bad|16 week follow-up|||patients|||Number
772710|NCT00733421|Secondary|Dizziness/Sleepiness|Number of patients that experienced dizziness/sleepiness/fatigue, assessed by patient and documented in written questionnaire|During the 7-day pain medication period|||patients|||Number
772711|NCT00733421|Secondary|Gastro-intestinal Symptoms|Number of patients reporting any gastro-intestinal side effects; nausea and or vomiting, gastritis etc. assessed by patient and documented in written questionnaire|during the 7- day pain medication period|||patients|||Number
772712|NCT00733421|Secondary|Compliance to Base Medication|Number of patients that did not discontinue study medication before day 7|7-day study period, during study medication|||patients|||Number
772715|NCT00733499|Primary|Difference in the Mean VAS Pain Score Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 6 Months.|The visual analog scale (VAS) pain score asks the subject to place a vertical mark anywhere on a horizontal line (that is approximately 10 cm long) with 'No pain' listed on the left (scored as 0) and 'Very severe pain' labeled on the right (scored as 10). The subject is instructed to indicate the amount of pain they feel in their knee joint|6 Months Post Surgery|The number of participants analysed is based on the number of case report forms measuring the VAS pain score that we have in our database at the 6 month time point.||units on a scale||Standard Deviation|Mean
772716|NCT00733512|Secondary|Contrast Sensitivity|Contrast sensitivity is the measurement of how faded an image may become before it is indistinguishable. Contrast sensitivity was measured in photopic, mesopic, and mesopic with glare conditions at the following spatial frequencies: 1.5, 3, 6, 12, and 18 cpd (cycles per degree). Contrast sensitivity is measured in log units. A higher value for the logarithmic units translates to better contrast sensitivity.|1 week to 10 months|contrast sensitivity data was received for only 51 of 146 patients.||log units||Standard Deviation|Mean
772717|NCT00733512|Primary|Visual Acuity|Uncorrected Visual Acuity (UCVA) and Best Spectacle Corrected Visual Acuity (BSCVA) at distance (4 meters) and near at preferred distance and measured by logMAR. LogMAR is the “logarithm of the minimum angle of resolution”. It is a unit of measure for visual acuity (VA). A lower logMAR value indicates better visual acuity.|1 week to 10 months|||logMAR||Standard Deviation|Mean
772718|NCT00733746|Secondary|Response Rate|The response rates to preoperative chemotherapy for patients treated with preoperative gemcitabine and erlotinib and rates of accurate pathologic assessment of the resected tumor specimen according to College of American Pathology guidelines will be estimated with a binomial point estimate and corresponding 95% confidence intervals.|Up to 4 years postoperative chemotherapy treatment|All patients that completed neoadjuvant treatment and were eligible for protocol surgery were included in this endpoint.||proportion of patients||95% Confidence Interval|Number
772719|NCT00733746|Secondary|Number of Participants Experiencing Grade 3 or Higher Adverse Events as Graded by the NCI’s Common Toxicity Criteria for Adverse Events|The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns. These patterns will be summarized with descriptive statistics. The number of patients reporting grade 3 or higher adverse events as graded by the NCI’s Common Toxicity Criteria (CTCAE) Version 4 are reported here. A complete list of all reported adverse events is reported in the Adverse Events section of this report.|Up to 4 years postoperative chemotherapy treatment|All patients that started protocol treatment and were assessed for adverse events were included in this endpoint.||Participants|||Count of Participants
772720|NCT00733746|Secondary|Relapse/Progression-free Survival|Relapse/progression-free survival is defined as the time from date of registration to the date of documentation of disease recurrence/progression. If a patient dies without documentation of disease recurrence/progression, the patient will be considered to have had disease recurrence/progression at the time of their death unless there is sufficient documented evidence to conclude no recurrence/progression occurred prior to death. If a patient is declared to be a major treatment violation, the patient will be censored on the date the treatment violation occurred. If a patient is lost to follow-up, s/he will be censored at the data of last contact. The distribution of disease-free survival will be estimated using the method of Kaplan and Meier.|At 2 years post-registration|All patients meeting the eligibility criteria who completed neoadjuvant therapy and underwent protocol surgery with R0 or R1 resection were evaluated for the primary endpoint.||months||95% Confidence Interval|Median
772721|NCT00733746|Secondary|Resection Rate|"The resection rate is defined as the fraction of patients that proceed to planned surgery with removal of primary tumor (R0/R1) following neoadjuvant treatment with gemcitabine plus erlotinib.The resection rate will be estimated by the binomial point estimate, i.e. as the number of patients that undergo the planned surgery with removal of the primary tumor following neoadjuvant treatment with gemcitabine plus erlotinib divided by the number of evaluable patients. This quantity will also be estimated with a 95% binomial confidence interval.
Curative resection (R0) is defined as macroscopically and microscopically complete resection (with microscopic surgical margin assessment according to AJCC Staging Principles).
An R1 resection is defined as macroscopically complete tumor removal with any positive microscopic surgical margin (bile duct, pancreatic parenchyma, or SMA margins)."|Up to 4 years postoperative chemotherapy treatment|All patients that completed neoadjuvant treatment and were eligible for surgery were included in this endpoint.||proportion of patients||95% Confidence Interval|Geometric Least Squares Mean
772722|NCT00733746|Primary|Overall Survival at 2 Years|The primary endpoint of this trial is 2-year overall survival, which will be evaluated as the proportion of treatment successes. A treatment success is defined to be an evaluable patient who is alive at two years from the date of registration.|At 2 years post-registration|All patients meeting the eligibility criteria who completed neoadjuvant therapy and underwent protocol surgery with R0 or R1 resection were evaluated for the primary endpoint.||proportion of patients||95% Confidence Interval|Number
772723|NCT00733824|Secondary|Toxicity of the Combination IV AMD3100 and G-CSF to Mobilize ≥ 2 x 106 CD34+ Cells/kg as Measured by Number of Participants Who Experience Grade 3 or Higher Adverse Event Broken Down by Adverse Event||30 days post transplant|||participants|||Number
772724|NCT00733824|Secondary|Pharmacodynamic Response to a Dose of SC AMD3100 as Measured by Mean Percentage of the Circulating CD34+ Count With the 34+RA-123+/- Phenotype||1 year|||mean percentage of total CD34+ cells||Standard Deviation|Mean
772725|NCT00733824|Secondary|Kinetics of Stem Cell Mobilization Using IV AMD3100 as Measured by Median Fold Change in the Number of CD34+ Cells After AMD3100 IV Administration||From baseline to Day 1|||fold change||Full Range|Median
772726|NCT00733824|Primary|Number of Participants Who Experienced Dose Limiting Toxicities in Phase I Portion of Study|Dose limiting toxicity: selected grade III or higher (hematologic, cardiac, pulmonary, hepatobiliary/pancreatic, renal, or CNS) not attributable to any other cause.|7 days from first dose of IV AMD3100|||participants|||Number
772727|NCT00733824|Primary|Maximum Tolerated Dose (MTD) of IV AMD3100 + G-CSF in Mobilization of Peripheral Blood Stem Cell in Patients With Lymphoma (Phase I Only)|"MTD: the highest dose level of AMD3100 at which ≤ 1 of 6 participants experience a dose limiting toxicity (DLT). The MTD will be the Phase II dose.
DLT: selected grade III or higher (hematologic, cardiac, pulmonary, hepatobiliary/pancreatic, renal, or CNS) not attributable to any other cause."|7 days from first dose of IV AMD3100|||micrograms/kilograms|||Number
772729|NCT00733954|Secondary|Percent Decrease in Body Surface Area Treated (%BSA Treated) From Baseline to Two Weeks Post Treatment|Percent decrease in body surface area treated (%BSA treated) from Baseline to two weeks post treatment (week 6 for clobetasol propionate spray and week 4 for clobetasol propionate ointment)|Baseline and Week 4 and Baseline and Week 6|ITT, LOCF||% BSA||Standard Deviation|Mean
772730|NCT00733954|Secondary|Percent Decrease in Body Surface Area Affected (%BSA Affected) From Baseline to Two Weeks Post Treatment|Percent decrease in body surface area affected (%BSA affected) from Baseline two weeks post treatment (week 6 for clobetasol propionate spray and week 4 for clobetasol propionate ointment)|Baseline and Week 4 and Baseline and Week 6|ITT, LOCF||% BSA||Standard Deviation|Mean
772731|NCT00733954|Secondary|Percent Decrease in Body Surface Area Treated (%BSA Treated) From Baseline to End of Treatment|Percent decrease from baseline in body surface area treated (%BSA treated) from Baseline to end of treatment (week 4 for clobetasol propionate spray and week 2 for clobetasol propionate ointment)|Baseline and Week 2 and Baseline and Week 4|ITT, LOCF||% BSA||Standard Deviation|Mean
772732|NCT00733954|Secondary|Percent Decrease in Body Surface Area Affected (%BSA Affected) From Baseline to End of Treatment|Percent decrease in body surface area affected (%BSA affected) from Baseline to end of treatment (week 4 for clobetasol propionate spray and week 2 for clobetasol propionate ointment)|Baseline and Week 2 and Baseline and Week 4|ITT, LOCF||% BSA||Standard Deviation|Mean
772733|NCT00733954|Secondary|Percent Decrease in Body Surface Area Treated (%BSA Treated) From Baseline to After Two Weeks of Treatment|Percent decrease from baseline in Body Surface Area treated (% BSA treated) from Baseline to after two weeks of treatment|Baseline and Week 2|ITT, LOCF||% BSA||Standard Deviation|Mean
772734|NCT00733954|Secondary|Percent Decrease in Body Surface Area Affected (%BSA Affected) From Baseline to After Two Weeks of Treatment|Percent decrease in Body Surface Area affected (% BSA affected) from Baseline to after two weeks of treatment|Baseline and Week 2|ITT, LOCF||% BSA||Standard Deviation|Mean
772735|NCT00733954|Secondary|Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) From Baseline to Two Weeks Post Treatment|Success Rate on decrease in Signs of Psoriasis (plaque elevation) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost Clear being success and all others being failure from Baseline and 2 weeks post treatment (week 6 for clobetasol propionate spray and week 4 for clobetasol propionate ointment)|Baseline and Week 4 and Baseline and Week 6|ITT, LOCF||Participants|||Number
772736|NCT00733954|Secondary|Number of Participants With Decrease in Signs of Psoriasis (Scaling) From Baseline to Two Weeks Post Treatment|Success Rate on decrease in Signs of Psoriasis (scaling) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost Clear being success and all others being failure from Baseline to 2 weeks post treatment (week 6 for clobetasol propionate spray and week 4 for clobetasol propionate ointment)|Baseline and Week 4 and Baseline and Week 6|ITT, LOCF||Participants|||Number
772737|NCT00733954|Secondary|Number of Participants With Decrease in Signs of Psoriasis (Erythema) From Baseline to Two Weeks Post Treatment|Success Rate on decrease in Signs of Psoriasis (erythema) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost Clear being success and all others being failure from Baseline to 2 weeks post treatment (week 6 for clobetasol propionate spray and week 4 for clobetasol propionate ointment)|Baseline and Week 4 and Baseline and Week 6|ITT, LOCF||Participants|||Number
772738|NCT00733954|Secondary|Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) From Baseline to End of Treatment|Success Rate on decrease in Signs of Psoriasis (plaque elevation) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost Clear being success and all others being failure from Baseline to end of treatment (week 4 for clobetasol propionate spray and week 2 for clobetasol propionate ointment)|Baseline and Week 2 and Baseline and Week 4|ITT, LOCF||Participants|||Number
772739|NCT00733954|Secondary|Number of Participants With Decrease in Signs of Psoriasis (Scaling) From Baseline to End of Treatment|Success Rate on decrease in Signs of Psoriasis (scaling) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost Clear being success and all others being failure from Baseline to end of treatment (week 4 for clobetasol propionate spray and week 2 for clobetasol propionate ointment)|Baseline and Week 2 and Baseline and Week 4|ITT, LOCF||Participants|||Number
772740|NCT00733954|Secondary|Number of Participants With Decrease in Signs of Psoriasis (Erythema) From Baseline to End of Treatment|Success Rate on decrease in Signs of Psoriasis (erythema) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost Clear being success and all others failure from Baseline to end of treatment (week 4 for clobetasol propionate spray and week 2 for clobetasol propionate ointment)|Baseline and Week 2 and Baseline and Week 4|ITT, LOCF||Participants|||Number
772741|NCT00733954|Secondary|Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) From Baseline to After Two Weeks of Treatment|Success Rate of decrease in Signs of Psoriasis (plaque elevation) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost clear being success and all others being failure from Baseline to after 2 weeks of treatment|Baseline and Week 2|ITT, LOCF||Participants|||Number
772742|NCT00733954|Secondary|Number of Participants With Decrease in Signs of Psoriasis (Scaling) From Baseline to After Two Weeks of Treatment|Success Rate of decrease in Signs of Psoriasis (scaling) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost clear being success and all others being failure from Baseline to after 2 weeks of treatment|Baseline and Week 2|ITT, LOCF||Participants|||Number
772743|NCT00733954|Secondary|Number of Participants With Decrease in Signs of Psoriasis (Erythema) From Baseline to After Two Weeks of Treatment|Success Rate of decrease in Signs of Psoriasis (erythema) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost clear being success and all others being failure from Baseline to after 2 weeks of treatment|Baseline and Week 2|ITT, LOCF||Participants|||Number
772744|NCT00733954|Secondary|Number of Participants Who Are Clear/Almost Clear of Plaque Psoriasis From Baseline to 2 Weeks Post Treatment Based on the Overall Disease Severity (ODS) Scale|Success Rate on Overall Disease Severity scale (Clear/Almost Clear, Moderate, Severe/Very Severe) with Clear/Almost Clear being best and Severe/Very Severe being worst at 2 weeks post treatment (week 6 - clobetasol propionate spray and week 4 - clobetasol propionate ointment)|Baseline and Week 4 and Baseline and Week 6|ITT, LOCF||Participants|||Number
772803|NCT00734162|Secondary|Change From Baseline in Z-score for Whole Body BMD at Week 96|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 96|Participants in the Safety Analysis Set with available data were analyzed.||z-score||Standard Deviation|Mean
772745|NCT00733954|Secondary|Number of Participants Who Are Clear/Almost Clear of Plaque Psoriasis From Baseline to After Two Weeks of Treatment Based on the Overall Disease Severity (ODS) Scale|Success Rate on Overall Disease Severity (ODS) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost Clear being best and Severe/Very Severe being worst from Baseline to after 2 weeks of treatment|Baseline and Week 2|||Participants|||Number
772746|NCT00733954|Primary|Number of Participants Who Are Clear/Almost Clear of Plaque Psoriasis From Baseline to End of Treatment Based on the Overall Disease Severity (ODS) Scale|Success Rate on Overall Disease Severity (ODS) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe with Clear/Almost Clear being best and Severe/Very Severe being worst) from Baseline to End of Treatment (wk 4 - clobetasol propionate spray; wk 2 - clobetasol propionate ointment)|Baseline and Week 2 and Baseline and Week 4|Intent-to-treat (ITT), Last observation carried forward (LOCF)||Participants|||Number
772747|NCT00733993|Secondary|Saliva Caffeine and Paraxanthine Levels|"Due to insufficient oral volume or breakage during sample transfer, data were lost or incomplete for two cocaine-dependent subjects.
Analyses for the saliva data represent 11 cocaine-dependent subjects and 10 controls."|30 minutes prior to dose, 30/90/150 minutes post dose.|Assessment was not performed for amphetamine intervention||ng/mL||Standard Error|Mean
772748|NCT00733993|Secondary|Probabalistic Feedback Selection Task|Accuracy on a range from 0 to 1 of correctly performing a learning task, with 1 being the highest degree of accuracy.|75 minutes after dose|||accuracy||Standard Error|Mean
772749|NCT00733993|Primary|Drug Effects Questionnaire Rating of Subjective Ratings of Drug Effects|Assessments measured using a 4 item Drug Effects Questionnaire (DEQ) Ranges from 0 to 100 with higher numbers showing greater effect for each scale.|Immediately after dose|||units on a scale||Standard Error|Mean
772750|NCT00733993|Primary|Addiction Research Center Inventory Subjective Rating of Drug Effects|"Addiction Research Center Inventory (ARCI 49). T/F scales with 49 items.
Includes the following subscales:
Morphine-Benzedrine Group (MBG), includes euphoria (0 to +16, higher numbers = more euphoria) Phenobarbital-Chorpromazine-Alcohol Group (PCAG), includes sedation (-3 to +11, higher scores = more sedation) Lysergic Acid Diethylmide Group (LSD) , includes dysphoria and agitation (-4 to +10, higher scores = more dysphoria) Amphetamine Group (A), includes stimulation ( 0 to +11, higher scores = more stimulation) Benzedrine Group (BG), includes energy and intellectual efficiacy (+4 to +9, higher scores = more energy)"|Immediately after dose|||units on a scale||Standard Error|Mean
772751|NCT00733993|Primary|Heart Rate|Sitting heart rate|Average across 7 time points: Immediately after dose and every 30 minutes for 3 hours|||Beats per minute||Standard Error|Mean
772752|NCT00733993|Primary|Systolic and Diastolic Blood Pressure|Sitting Blood Pressure|Average across 7 time points: Immediately after dose and every 30 minutes for 3 hours|||mmHg||Standard Error|Mean
772753|NCT00733993|Primary|Visual Analog Scale Subjective Rating of Drug Effects|Visual Analog Scale Rating. Scores range from 0 to 100 with higher scores meaning greater intensity of response being rated.|Immediately after dose|||units on a scale||Standard Error|Mean
772754|NCT00734071|Secondary|Health Care Resource Utilization as Assessed by the Health Economic Assessment Questionnaire|Healthcare resource utilization was assessed by the Health Economic Assessment (HEA) questionnaire, which monitors the participants absenteeism from work, as well as resource use such as visits to a general practitioner, outpatient and inpatient services, hospitalization, medications, and other relevant services over the past 8 weeks.|Baseline and Week 8|Full analysis set with available data at Baseline (139 and 136 patients) and at Week 8 (122 and 131 patients).||participants|||Number
772755|NCT00734071|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Mental Health Subscore at Each Week Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The mental health sub-score assesses general mental health (psychological distress and well-being) and ranges from 0 (best) - 100 (worst). LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 2, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used. n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
772756|NCT00734071|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Emotional Subscore at Each Week Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The role-emotional subscale assesses limitations in usual role activities because of emotional problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 2, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used. n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
772757|NCT00734071|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Vitality Subscore at Each Week Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The vitality sub-score assesses energy and fatigue, and ranges from 0 (best) - 100 (worst). LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 2, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used. n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
772758|NCT00734071|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Subscore at Each Week Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The general health sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 2, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used. n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
775455|NCT00757003|Secondary|Overall Survival|Overall survival is reported as the count of participants alive 60 months following implant procedure.|60 months|9 lost to followup, 4 withdrew, 2 explanted, 1 never implanted, all excluded||Participants|||Count of Participants
772759|NCT00734071|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Bodily Pain Subscore at Each Week Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The bodily pain sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 2, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used. n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
772760|NCT00734071|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Physical Subscore at Each Week Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The role-physical subscale assesses limitations in usual role activities because of physical health problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 2, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used. n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
772761|NCT00734071|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Physical Functioning Subscore at Each Week Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The physical functioning subscale assesses limitations in physical activities because of health problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 2, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used. n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
772762|NCT00734071|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Other Weeks Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The social functioning subscale assesses limitations in social activities because of physical or emotional problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 2 and 4|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used. n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
772763|NCT00734071|Secondary|Change From Baseline in the Hospital Anxiety and Depression (HAD) Depression Subscale at Each Week Assessed|The HAD-Depression subscale is completed by the participant and measures depression, focusing on the state of lost interest and diminished pleasure response. The subscale is made up of 7 items that are assessed on a scale from 0 (no depression) to 3 (severe feeling of depression). Participants are required to indicate the response which most accurately reflects the way they have felt over the last few days. The item scores are summed and the total subscore ranges from 0 to 21 (maximal severity). LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 1, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used. n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
772764|NCT00734071|Secondary|Change From Baseline in Clinical Global Impression Scale-Severity of Illness at Each Week Assessed|The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 1, 2, 4, 6 and 8|"Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used. n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
772765|NCT00734071|Secondary|Percentage of Participants in HAM-A Remission at Each Week Assessed|Remission is defined as a Hamilton Anxiety Scale (HAM-A) total score ≤ 7. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity).|Weeks 1, 2, 4, 6 and 8|"Full analysis set; Last observation carried forward was used. n indicates the number of patients included in the analysis at each time point."||percentage of participants|||Number
772766|NCT00734071|Secondary|Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed in Participants With Baseline HAM-A ≥25|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Least Squares (LS) means were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 1, 2, 4 and 6|"Full analysis set patients with a HAM-A Baseline score ≥25. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
772804|NCT00734162|Secondary|Change From Baseline in Z-score for Whole Body BMD at Week 72|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 72|Participants in the Safety Analysis Set with available data were analyzed.||z-score||Standard Deviation|Mean
772767|NCT00734071|Secondary|Percentage of Responders in HAM-A Total Score at Other Weeks Assessed|Response was defined as participants with a ≥50% decrease from Baseline in the Hamilton Anxiety Scale (HAM-A) total score. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity).|Baseline and Weeks 1, 2, 4 and 6|"Full analysis set; Last observation carried forward was used; n indicates the number of patients included in the analysis at each time point."||percentage of participants|||Number
772768|NCT00734071|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Other Weeks Assessed|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means and P-values were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 1, 2 and 4|"Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
772769|NCT00734071|Secondary|Clinical Global Impression Scale-Global Improvement at Other Weeks Assessed|The Clinical Global Impression - Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 1, 2, 4 and 6|"Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
772770|NCT00734071|Secondary|Change From Baseline in the Hospital Anxiety and Depression (HAD) Anxiety Subscale at Other Weeks Assessed|The Hospital Anxiety and Depression (HAD) Anxiety sub-scale consists of 7 items that are assessed by a scale from 0 (no anxiety) to 3 (severe feeling of anxiety). The anxiety subscale determines a state of generalized anxiety including anxious mood, restlessness, anxious thoughts and panic attacks. Scores are summed and range from 0 to 21 (maximal severity). LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 1 and 4|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
772771|NCT00734071|Secondary|Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Least Squares (LS) means were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 1, 2, 4 and 6.|"The Full Analysis Set. A mixed model for repeated measurements (MMRM) based on observed cases was used. n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
772772|NCT00734071|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Week 8|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The social functioning subscale assesses limitations in social activities because of physical or emotional problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Week 8|The Full Analysis Set. A mixed model for repeated measurements (MMRM) based on observed cases was used.||scores on a scale||Standard Error|Least Squares Mean
772773|NCT00734071|Secondary|Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8 in Participants With Baseline HAM-A ≥25|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Least Squares (LS) means were from a mixed model for repeated measurements (MMRM).|Baseline to Week 8|Full analysis set patients with a HAM-A Baseline score ≥25. A mixed model for repeated measurements (MMRM) based on observed cases was used.||scores on a scale||Standard Error|Least Squares Mean
772774|NCT00734071|Secondary|Percentage of Responders in HAM-A Total Score at Week 8|Response was defined as participants with a ≥50% decrease from Baseline in the Hamilton Anxiety Scale (HAM-A) total score. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity).|Baseline and Week 8|Full analysis set; Last observation carried forward was used.||percentage of participants|||Number
772775|NCT00734071|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Week 8|Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.||scores on a scale||Standard Error|Least Squares Mean
772776|NCT00734071|Secondary|Clinical Global Impression Scale-Global Improvement at Week 8|The Clinical Global Impression - Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Week 8|Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.||scores on a scale||Standard Error|Least Squares Mean
772777|NCT00734071|Secondary|Change From Baseline in the Hospital Anxiety and Depression (HAD) Anxiety Subscale at Week 8|The Hospital Anxiety and Depression (HAD) Anxiety sub-scale consists of 7 items that are assessed by a scale from 0 (no anxiety) to 3 (severe feeling of anxiety). The anxiety subscale determines a state of generalized anxiety including anxious mood, restlessness, anxious thoughts and panic attacks. Scores are summed and range from 0 to 21 (maximal severity). LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Week 8|The Full Analysis Set. A mixed model for repeated measurements (MMRM) based on observed cases was used.||scores on a scale||Standard Error|Least Squares Mean
772778|NCT00734071|Primary|Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Least Squares (LS) means were from a mixed model for repeated measurements (MMRM).|Baseline to Week 8|The Full Analysis Set included all patients who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline value for assessment of primary efficacy. A mixed model for repeated measurements (MMRM) based on observed cases was used.||scores on a scale||Standard Error|Least Squares Mean
772779|NCT00734097|Secondary|Change in Severity of Acid Regurgitation After 4 Weeks of Treatment|"Reported severity of acid regurgitation at week 4 on RDQ - reported severity of acid regurgitation at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from None to Severe.
Four dimensions are defined for the RDQ – heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe)."|At Baseline and 4 weeks|||Units of scale||Standard Deviation|Mean
772780|NCT00734097|Secondary|Change in Severity of Acid Regurgitation After 8 Weeks of Treatment|"Reported severity of acid regurgitation at week 8 on RDQ - reported severity of acid regurgitation at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from None to Severe.
Four dimensions are defined for the RDQ – heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe)."|At Baseline and 8 weeks|||Units of scale||Standard Deviation|Mean
772781|NCT00734097|Secondary|Change in Severity of Epigastric Pain After 4 Weeks of Treatment|"Reported severity of epigastric pain at week 4 on RDQ - reported severity of epigastric pain at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from None to Severe.
Four dimensions are defined for the RDQ – heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe)."|At Baseline and 4 weeks|||Units of scale||Standard Deviation|Mean
772782|NCT00734097|Secondary|Change in Severity of Epigastric Pain After 8 Weeks of Treatment|"Reported severity of epigastric pain at week 8 on RDQ - reported severity of epigastric pain at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from None to Severe.
Four dimensions are defined for the RDQ – heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe)."|At Baseline and 8 weeks|||Units of scale||Standard Deviation|Mean
772783|NCT00734097|Secondary|Change in Frequency of Epigastric Pain After 8 Weeks of Treatment|"Reported frequency of days with Epigastric Pain at week 8 - reported frequency of days with Epigastric Pain at baseline.
Four dimensions are defined for the Reflux Disease Questionnaire (RDQ) – heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension were range from 0 to 5 for frequency (not present to daily) and severity (not present to severe)."|At Baseline and 8 weeks|||Days per week with pain||Standard Deviation|Mean
772784|NCT00734097|Secondary|Change in Frequency of Epigastric Pain After 4 Weeks of Treatment|"Reported frequency of days with Epigastric Pain at week 4 - reported frequency of days with Epigastric Pain at baseline.
Four dimensions are defined for the Reflux Disease Questionnaire (RDQ) – heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe)."|At Baseline and 4 weeks|||Days per week with pain||Standard Deviation|Mean
772785|NCT00734097|Secondary|Change in Frequency of Days With Acid Regurgitation From Baseline to 8 Weeks of Treatment.|"Reported frequency of days with Acid regurgitation at week 8 - reported frequency of days with acid regurgitation at baseline.
Four dimensions are defined for the Reflux Disease Questionnaire (RDQ) – heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe)."|At Baseline and 8 weeks.|||Days per week with symptoms||Standard Deviation|Mean
772786|NCT00734097|Secondary|Change in Frequency of Days With Acid Regurgitation From Baseline to 4 Weeks of Treatment.|"Reported frequency of days with Acid regurgitation at week 4 - reported frequency of days with acid regurgitation at baseline.
Four dimensions are defined for the Reflux Disease Questionnaire (RDQ) – heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe)."|At Baseline and 4 weeks.|||Days per week with symptoms||Standard Deviation|Mean
772805|NCT00734162|Secondary|Change From Baseline in Z-score for Whole Body BMD at Week 48|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 48|Participants in the Safety Analysis Set with available data were analyzed.||z-score||Standard Deviation|Mean
786188|NCT00833690|Secondary|Serum Urate|From blood sample drawn after taking study drug that day|Visit 04 (Week 9; 63 +/- 5 days after Baseline Visit)|||mg/dL||Standard Deviation|Mean
772787|NCT00734097|Secondary|Change in Severity of Heartburn From Baseline to 4 Weeks of Treatment|"Reported severity of heartburn at week 4 on RDQ - reported severity of heartburn at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from None to Severe.
Four dimensions are defined for the RDQ – heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe)."|At Baseline and 4 weeks|||Units on scale||Standard Deviation|Mean
772788|NCT00734097|Secondary|Change in Severity of Heartburn From Baseline to 8 Weeks of Treatment|"Reported severity of heartburn at week 8 on RDQ - reported severity of heartburn at baseline on RDQ RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from None to Severe.
Four dimensions are defined for the RDQ – heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe)."|At Baseline and 8 weeks|||Units of scale||Standard Deviation|Mean
772789|NCT00734097|Secondary|Change in Frequency of Days With Heartburn From Baseline to 4 Weeks of Treatment|Reported frequency of days with heartburn at week 4 - reported frequency of days with heartburn at baseline.|At Baseline and 4 weeks|||Days per week with symptoms||Standard Deviation|Mean
772790|NCT00734097|Primary|Change in Frequency of Days With Heartburn From Baseline to 8 Weeks of Treatment|Reported frequency of days with heartburn at week 8 - reported frequency of days with heartburn at baseline|At Baseline and 8 weeks|||Days per week with symptoms||Standard Deviation|Mean
772791|NCT00734149|Secondary|Median Duration of Response|Duration of response is measured from date of first confirmed response until date of disease progression.|up to 4 years|||months||95% Confidence Interval|Median
772792|NCT00734149|Secondary|Number of Patients With Any Grade or Severe Adverse Event|Number of patients with any grade or severe, defined as ≥ grade 3 by Common Terminology Criteria for Adverse Events (CTCAE) v4.0, adverse events as a measure of safety|At any time during the study and up to 30 days after stopping the study drug|||participants|||Number
772793|NCT00734149|Primary|Response|Overall response rate equals complete response and partial response per Southwest Oncology Group Criteria. Measurable, quantifiable protein criteria must be present. Acceptable protein criteria are quantitative immunoglobulin IgG, IgA, IgD, IgE or IgM and/or urine M-component (Bence-Jones protein). If both are present, the quantitative immunoglobulin will be followed for response. Complete Remission: The absence of bone marrow or blood findings of multiple myeloma. This includes disappearance of all evidence of serum and urine M-components on electrophoresis as by immunofixation studies. There must also be no evidence of increasing anemia. Partial Remission: A 50-74% reduction in the quantitative immunoglobulin, and if present, a 50-89% reduction in the urine M-component (Bence-Jones protein). Stable/No Remission): A <50% reduction I nthe quantitative immunoglobulin, or if the patient has light-chain disease only, a <50% reduction in the urine M-component (Bence-Jones protein.|6 weeks following completion of treatment|||participants|||Number
772794|NCT00734162|Secondary|Percentage of Participants Who Were HBeAg-Positive With Abnormal ALT at Baseline Who Had HBV DNA < 400 Copies/mL, Normalized ALT, and HBeAg Loss/Seroconversion at Weeks 48, 72, 96, 144, and 192|Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method.|Baseline; Weeks 48, 72, 96, 144, and 192|Participants in the Full Analysis Set who were HBeAg-Positive with abnormal ALT at baseline were analyzed.||percentage of participants|||Number
772795|NCT00734162|Secondary|Percentage of Participants With Abnormal ALT at Baseline Who Had HBV DNA < 400 Copies/mL and Normalized ALT at Weeks 48, 72, 96, 144, and 192|Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method.|Baseline; Weeks 48, 72, 96, 144, and 192|Participants in the Full Analysis Set with abnormal ALT at baseline were analyzed.||percentage of participants|||Number
772796|NCT00734162|Secondary|Percentage of Participants With Abnormal ALT at Baseline Who Had Normalized ALT at Weeks 48, 72, 96, 144, and 192|Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method.|Baseline; Weeks 48, 72, 96, 144, and 192|Participants in the Full Analysis Set with abnormal ALT at baseline were analyzed.||percentage of participants|||Number
772797|NCT00734162|Secondary|Percentage of Participants Who Were HBeAg-Positive at Baseline Who Had HBV DNA < 400 Copies/mL, Normal ALT, and HBeAg Loss/Seroconversion at Weeks 48, 72, 96, 144, and 192|Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method.|Baseline; Weeks 48, 72, 96, 144, and 192|Participants in the Full Analysis Set who were HBeAg-positive at baseline were analyzed.||percentage of participants|||Number
772798|NCT00734162|Secondary|Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Seroconversion at Weeks 48, 72, 96, 144, and 192|Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method.|Baseline; Weeks 48, 72, 96, 144, and 192|Participants in the Full Analysis Set who were HBeAg-positive at baseline were analyzed.||percentage of participants|||Number
772799|NCT00734162|Secondary|Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Loss at Weeks 48, 72, 96, 144, and 192|Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method.|Baseline; Weeks 48, 72, 96, 144, and 192|Participants in the Full Analysis Set who were HBeAg-positive at baseline were analyzed.||percentage of participants|||Number
772800|NCT00734162|Secondary|Number of Participants With Changes in Drug-Resistant Mutations During the Study|The number of participants with changes in drug-resistant mutations during the study was summarized.|Baseline through Week 192|Participants with HBV DNA ≥ 400 copies/mL, with confirmed virologic breakthrough (defined as 2 consecutive increases in HBV DNA of at least 10-fold from nadir, or confirmed values ≥ 400 copies/mL after being < 400 copies/mL while on study medication), or subjects who discontinued early (after Week 24 with HBV DNA ≥ 400 copies/mL) were analyzed.||participants|||Number
772801|NCT00734162|Secondary|Change From Baseline in Z-score for Whole Body BMD at Week 192|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 192|Participants in the Safety Analysis Set with available data were analyzed.||z-score||Standard Deviation|Mean
772802|NCT00734162|Secondary|Change From Baseline in Z-score for Whole Body BMD at Week 144|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 144|Participants in the Safety Analysis Set with available data were analyzed.||z-score||Standard Deviation|Mean
772810|NCT00734162|Secondary|Change From Baseline in Z-score for Spine BMD at Week 48|To assess any effect of treatment on growth, Z-scores were used to express the deviation from a reference population for lumbar spine BMD. A Z-score of 0 indicated that a subject was typical of the population for their age, ethnicity, and gender. A negative Z-score indicated that the subject’s recorded value was lower than typical for their age, ethnicity, and gender. A positive Z-score indicates that the subject’s recorded value was higher than typical for their age, ethnicity, and gender. Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 48|Participants in the Safety Analysis Set with available data were analyzed.||z-score||Standard Deviation|Mean
772811|NCT00734162|Secondary|Percent Change From Baseline in Whole Body BMD at Week 192|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 192|Participants in the Safety Analysis Set with available data were analyzed.||percentage change||Standard Deviation|Mean
772812|NCT00734162|Secondary|Percent Change From Baseline in Whole Body BMD at Week 144|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 144|Participants in the Safety Analysis Set with available data were analyzed.||percentage change||Standard Deviation|Mean
772813|NCT00734162|Secondary|Percent Change From Baseline in Whole Body BMD at Week 96|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 96|Participants in the Safety Analysis Set with available data were analyzed.||percentage change||Standard Deviation|Mean
772814|NCT00734162|Secondary|Percent Change From Baseline in Whole Body BMD at Week 72|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 72|Participants in the Safety Analysis Set with available data were analyzed.||percentage change||Standard Deviation|Mean
772815|NCT00734162|Secondary|Percent Change From Baseline in Whole Body BMD at Week 48|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 48|Participants in the Safety Analysis Set with available data were analyzed.||percentage change||Standard Deviation|Mean
772816|NCT00734162|Secondary|Percent Change From Baseline in Spine BMD at Week 192|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 192|Participants in the Safety Analysis Set with available data were analyzed.||percentage change||Standard Deviation|Mean
772817|NCT00734162|Secondary|Percent Change From Baseline in Spine BMD at Week 144|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 144|Participants in the Safety Analysis Set with available data were analyzed.||percentage change||Standard Deviation|Mean
772818|NCT00734162|Secondary|Percent Change From Baseline in Spine BMD at Week 96|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 96|Participants in the Safety Analysis Set with available data were analyzed.||percentage change||Standard Deviation|Mean
772819|NCT00734162|Secondary|Percent Change From Baseline in Spine BMD at Week 72|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 72|Participants in the Safety Analysis Set with available data were analyzed.||percentage change||Standard Deviation|Mean
772820|NCT00734162|Secondary|Percent Change From Baseline in Spine Bone Mineral Density (BMD) at Week 48|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 48|Participants in the Safety Analysis Set with available data were analyzed.||percentage change||Standard Deviation|Mean
772821|NCT00734162|Secondary|Percentage of Participants With at Least a 6% Decrease From Baseline in Whole Body BMD at Weeks 48, 72, 96, 144, and 192|The percentage of participants reported is the cumulative incidence from baseline to the respective time point. Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Weeks 48, 72, 96, 144, and 192|Safety Analysis Set||percentage of participants|||Number
772822|NCT00734162|Secondary|Percentage of Participants With at Least a 6% Decrease From Baseline in Spine BMD at Weeks 48, 96, 144, and 192|The percentage of participants reported is the cumulative incidence from baseline to the respective time point. Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Weeks 48, 96, 144, and 192|Safety Analysis Set||percentage of participants|||Number
772823|NCT00734162|Secondary|Percentage of Participants With HBsAg Seroconversion at Weeks 48, 72, 96, 144, and 192|HBsAg seroconversion was defined as change of detectable antibody to HBsAg from negative to positive. Data were summarized by treatment and age group (grouped by baseline age for analysis), using the M = F.|Baseline; Weeks 48, 72, 96, 144, and 192|Full Analysis Set||percentage of participants|||Number
772824|NCT00734162|Secondary|Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48, 72, 96, 144, and 192|Data were summarized by treatment and age group (grouped by baseline age for analysis), using the M = F.|Baseline; Weeks 48, 72, 96, 144, and 192|Full Analysis Set||percentage of participants|||Number
772825|NCT00734162|Secondary|Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 72, 96, 144, and 192|Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method.|Weeks 48, 72, 96, 144, and 192|Full Analysis Set||percentage of participants|||Number
772826|NCT00734162|Secondary|Percentage of Participants With HBV DNA < 400 Copies/mL and Normal ALT at Weeks 48, 72, 96, 144, and 192|Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method.|Weeks 48, 72, 96, 144, and 192|Full Analysis Set||percentage of participants|||Number
772827|NCT00734162|Secondary|Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Weeks 48, 72, 96, 144, and 192|Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method.|Weeks 48, 72, 96, 144, and 192|Full Analysis Set||percentage of participants|||Number
772828|NCT00734162|Secondary|Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 96, 144, and 192|Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method.|Weeks 48, 96, 144, and 192|Full Analysis Set||percentage of participants|||Number
772884|NCT00734474|Secondary|Change From Baseline in Blood Pressure at Dose Decision Point|Sitting systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured at the dose decision point. Change from baseline in DBP was 1 of the 4 measures included in the clinical utility index (CUI) used to evaluate the dose decision. The maximum duration of exposure to LY2189265, Sitagliptin, or Placebo (across all treatment arms) at the time of the decision point was 27.4 weeks.|Baseline up to 27.4 weeks|All participants randomized before the dose decision point who had evaluable sitting SBP and DBP data.||millimeters of mercury (mmHg)||Standard Deviation|Mean
772829|NCT00734162|Primary|Percentage of Participants With at Least a 6% Decrease From Baseline in Bone Mineral Density (BMD) of the Spine at Week 72|"Data were summarized by treatment and age group (grouped by baseline age for analysis).
In contrast with what was previously reported in the interim results posting, 1 participant met the primary safety endpoint of at least a 6% decrease from baseline in spine BMD at Week 72, based on the final BMD data analysis. The apparent discrepancy was due to the correction factor applied to the subject-specific BMD calculations performed at the time of the Interim Week 72 clinical study report that could not take into account the actual Week 72 phantom data (ie, calibration test used in longitudinal clinical trials to monitor and adjust for shifts in the dual-energy x-ray absorptiometry (DXA) scanner calibration over time), which were not provided by the site at that time. The correction factor applied to the final analysis has been properly based on all phantom data through the end of Week 72, as well as through the end of Week 192."|Baseline to Week 72|Safety Analysis Set: participants who received at least one dose of study drug.||percentage of participants|||Number
772830|NCT00734162|Primary|Percentage of Participants With HBV DNA < 400 Copies/mL at Week 72|"The percentage of participants with HBV DNA < 400 copies/mL at Week 72 was summarized by treatment and age group (grouped by baseline age for analysis), using the missing = failure (M = F) analysis with the double-blind efficacy evaluation (DBEE) algorithm.
In the M = F analysis method, all missing data were considered as failure to meet the outcome measure threshold. This method was combined with the DBEE algorithm, which included all available data for the double-blind period, and any data for the open-label period were not included; data generated during treatment-free follow-up from subjects who achieved HBsAg loss and entered treatment-free follow-up during double-blind treatment period were included."|Week 72|Full Analysis Set: participants who were randomized and received at least one dose of study drug||percentage of participants|||Number
772831|NCT00734214|Primary|Hyponatremia|Plasma sodium less than 135 mmol/L|during the study intervention|Intention to treat analysis||participants|||Number
772832|NCT00734214|Secondary|Adjudicated Morbidity Attributed to Acute Plasma Sodium Changes.||During the treatment and follow-up period||||||
772833|NCT00734214|Primary|Hospital Acquired Acute Plasma Sodium Derangements (Hypo- or Hypernatremia)||During the treatment and follow-up period.||||||
772834|NCT00734305|Secondary|To Determine the Pharmacokinetic Parameters of MM-121|Pharmacokinetic (PK) evaluation was performed on plasma samples obtained weekly for the first cycle of the study and then on day 1 of each additional cycle to assess pre-treatment trough concentrations of MM-121. The AUC is presented and was calculated usig Non-compartmental analysis (NCA). Serum levels of MM-121 were measured at a central lab using an enzyme-linked immunosorbent assay (ELISA). Data is presented per dose level of MM-121 (3.2 mg/kg, 6 mg/kg, 10 mg/kg, 15 mg/kg, 20 mg/kg, 40/20 mg/kg).|At Cycle 1, Week 1 pre-treatment, at the end of the infusion, and 2, 4, 8, 24, 48 and 72 hours after starting the infusion; pre-dose collections on Cycle 1, Week 2 and Cycle 2, Week 1 for all patients|All patients. NOTE: There are 22 patients included in the final cohort (4 patients in dose escalation portion Cohort 6 + 18 patients in Expansion Cohort), as PK analysis was performed per dose level and not per cohort. Cohort 6 and the Expansion Cohort were administered the same dose, and therefore the analysis reflects all 22 patients.||hr* ug/mL||Geometric Coefficient of Variation|Geometric Mean
772835|NCT00734305|Secondary|To Determine the Pharmacokinetic and Immunogenicity Parameters of MM-121|"Pharmacokinetic (PK) evaluation was performed on plasma samples obtained weekly for the first cycle of the study and then on day 1 of each additional cycle to assess pre-treatment trough concentrations of MM-121. The maximum observed concentration (Cmax) is presented and was calculated usig Non-compartmental analysis (NCA). Serum levels of MM-121 were measured at a central lab using an enzyme-linked immunosorbent assay (ELISA). Data is presented per dose level of MM-121 (3.2 mg/kg, 6 mg/kg, 10 mg/kg, 15 mg/kg, 20 mg/kg, 40/20 mg/kg).
Immunogenicity data is not available."|At Cycle 1, Week 1 pre-treatment, at the end of the infusion, and 2, 4, 8, 24, 48 and 72 hours after starting the infusion; pre-dose collections on Cycle 1, Week 2 and Cycle 2, Week 1 for all patients|All patients. NOTE: There are 22 patients included in the final cohort (4 patients in dose escalation portion Cohort 6 + 18 patients in Expansion Cohort), as PK analysis was performed per dose level and not per cohort. Cohort 6 and the Expansion Cohort were administered the same dose, and therefore the analysis reflects all 22 patients.||ug/mL||Geometric Coefficient of Variation|Geometric Mean
772836|NCT00734305|Secondary|To Describe the Dose-limiting Toxicity of MM-121 as a Monotherapy|To establish the safety of escalating doses of MM-121 administered as a monotherapy in order to determine the recommended phase 2 dose. Dose-escalation conducted using standard 3+3 model to determine maximum tolerated dose. Reports of Dose-Limiting Toxicities (DLTs) were assessed to determine the MTD to be used for the expansion cohort. DLTs were not measured in the Expansion Cohort.|From date of first dose to 30 days after termination, the longest 47 weeks|||participants reporting DLTs|||Number
772837|NCT00734305|Primary|Determine the Maximum Tolerated Dose Dependent on Reports of Dose-limiting Toxicities|Using a 3+3 dose escalation model, the maximum tolerated dose was determined by assessing dose-limiting toxicities in each cohort from cohort 1-6. Cohort 1 began at 3.2 mg/kg IV QW and the dose escalated in separate cohorts from 6 mg/kg IV QW, 10 mg/kg IV QW, 15 mg/kg IV QW, 20 mg/kg IV QW, to the highest scheduled testing dose at 40 mg/kg one-time loading dose on cycle 1, week 1 followed by 20 mg/kg IV QW maintenance doses. If 3 patients were treated and passed the observation window, escalation to the next cohort was initiated. If a DLT was reported, 3-4 additional patients were enrolled and observed. If a DLT was observed in the expanded cohort, this dose was considered to be the maximum tolerated dose. The maximum tolerated dose was defined at the cohort in which two dose-limiting toxicities were observed, or as the highest target dose tested in the absence of DLTs. The determined MTD was considered the Recommended Phase 2 Dose and was used to open the expansion cohort.|From date of first dose to 30 days after termination, the longest 47 weeks|All participants in the 6 cohorts of dose escalation||mg/kg|||Number
772838|NCT00734305|Primary|Objective Response Rate and Duration|"To determine the number of patients reporting an objective response using RECIST v 1.1 where a Partial Response is defined as a >20% decrease in tumor burden from baseline and a Complete Response is defined as complete disappearance of tumor burden from baseline. Duration of response is defined as the length of time in weeks from observation of response until progression.
NOTE: because no patients experienced an objective response as shown below, duration of response is not presented. No duration of response could be measured."|Time from first dose to date of progression, with a median of 7.1 weeks|||participants with objective response|||Number
772839|NCT00734344|Primary|Mean CD4 Count Between Treatment Groups at 11 Months|Mean CD4 count between groups 11 months after of starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent).|11 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 9 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 9 subjects because either the subjects missed a visit or chose not to stop therapy||cells/mm3||Full Range|Mean
772840|NCT00734344|Primary|Mean CD4 Count Between Treatment Groups at 10 Months|Mean CD4 count between groups 10 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent).|10 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 8 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 7 subjects because either the subjects missed a visit or chose not to stop therapy||cells/mm3||Full Range|Mean
772841|NCT00734344|Primary|Mean CD4 Count Between Treatment Groups at 9 Months|Mean CD4 count between groups 9 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent).|9 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 8 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 8 subjects because either the subjects missed a visit or chose not to stop therapy||cells/mm3||Full Range|Mean
772842|NCT00734344|Primary|Mean CD4 Count Between Treatment Groups at 8 Months|Mean CD4 count between groups 8 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent).|8 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 5 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 7 subjects because either the subjects missed a visit or chose not to stop therapy||cells/mm3||Full Range|Mean
772843|NCT00734344|Primary|Mean CD4 Count Between Treatment Groups at 7 Months|Mean CD4 count between groups 7 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent).|7 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 5 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 7 subjects because either the subjects missed a visit or chose not to stop therapy||cells/mm3||Full Range|Mean
772844|NCT00734344|Primary|Mean CD4 Count Between Treatment Groups at 6 Months|Mean CD4 count between groups 6 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent).|6 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 4 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 7 subjects because either the subjects missed a visit or chose not to stop therapy||cells/mm3||Full Range|Mean
772845|NCT00734344|Primary|Mean CD4 Count Between Treatment Groups at 5 Months|Mean CD4 count between groups 5 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent).|5 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 3 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 4 subjects because either the subjects missed a visit or chose not to stop therapy||cells/mm3||Full Range|Mean
786189|NCT00833690|Secondary|Serum Urate|From blood sample drawn after taking study drug that day|Visit 03 (Week 6; 42 +/- 3 days after Baseline Visit)|||mg/dL||Standard Deviation|Mean
772846|NCT00734344|Primary|Mean CD4 Count Between Treatment Groups at 4 Months|Mean CD4 count between groups 4 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent).|4 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 4 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 7 subjects because either the subjects missed a visit or chose not to stop therapy||cells/mm3||Full Range|Mean
772847|NCT00734344|Primary|Mean CD4 Count Between Treatment Groups at 3 Months|Mean CD4 count between groups 3 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent).|3 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 1 subject because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 3 subjects because either the subjects missed a visit or chose not to stop therapy||cells/mm3||Full Range|Mean
772848|NCT00734344|Primary|Mean CD4 Count Between Treatment Groups at 2 Months|Mean CD4 count between groups 2 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent).|2 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 1 subject because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 1 subject because either the subjects missed a visit or chose not to stop therapy||cells/mm3||Full Range|Mean
772849|NCT00734344|Primary|Mean CD4 Count Between Treatment Groups at 1 Months|Mean CD4 count between groups 1 month after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410–1,590 cells/mm3. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent).|1 month after baseline|||cells/mm3||Full Range|Mean
772850|NCT00734344|Primary|Mean Platelet Count Between Treatment Groups at 14 Months|The mean platelet count between treatment groups at 14 months after starting study drug. The calculated number of platelets in a volume of blood, usually expressed as platelets per cubic millimeter (cmm) of whole blood. Platelets are the smallest cell-like structures in the blood and are important for blood clotting and plugging damaged blood vessels. Platelet counts are usually done by laboratory machines that also count other blood elements such as the white and red cells. They can also be counted by use of a microscope. Normal platelet counts are in the range of 150,000 to 400,000 per microliter (or 150 - 400 x 109 per liter).|4 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 8 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 6 subjects because either the subjects missed a visit or chose not to stop therapy||count per microliter||Full Range|Mean
772851|NCT00734344|Primary|Mean Platelet Count Between Treatment Groups at 12 Months|The mean platelet count between treatment groups at 12 months after starting study drug. The calculated number of platelets in a volume of blood, usually expressed as platelets per cubic millimeter (cmm) of whole blood. Platelets are the smallest cell-like structures in the blood and are important for blood clotting and plugging damaged blood vessels. Platelet counts are usually done by laboratory machines that also count other blood elements such as the white and red cells. They can also be counted by use of a microscope. Normal platelet counts are in the range of 150,000 to 400,000 per microliter (or 150 - 400 x 109 per liter).|12 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 6 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 5 subjects because either the subjects missed a visit or chose not to stop therapy||count per microliter||Full Range|Mean
772852|NCT00734344|Primary|Mean Platelet Count Between Treatment Groups at 10 Months|The mean platelet count between treatment groups at 10 months after starting study drug. The calculated number of platelets in a volume of blood, usually expressed as platelets per cubic millimeter (cmm) of whole blood. Platelets are the smallest cell-like structures in the blood and are important for blood clotting and plugging damaged blood vessels. Platelet counts are usually done by laboratory machines that also count other blood elements such as the white and red cells. They can also be counted by use of a microscope. Normal platelet counts are in the range of 150,000 to 400,000 per microliter (or 150 - 400 x 109 per liter).|10 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 7 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 7 subjects because either the subjects missed a visit or chose not to stop therapy||count per microliter||Full Range|Mean
772924|NCT00734578|Secondary|Percentage of Participants With Improvement on Parent Global Assessment (PGA) at Week 8 - LOCF|Parent Global Assessment (PGA) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|Baseline and week 8|FAS||Percent of participants|||Number
772853|NCT00734344|Primary|Mean Platelet Count Between Treatment Groups at 8 Months|The mean platelet count between treatment groups at 8 months after starting study drug. The calculated number of platelets in a volume of blood, usually expressed as platelets per cubic millimeter (cmm) of whole blood. Platelets are the smallest cell-like structures in the blood and are important for blood clotting and plugging damaged blood vessels. Platelet counts are usually done by laboratory machines that also count other blood elements such as the white and red cells. They can also be counted by use of a microscope. Normal platelet counts are in the range of 150,000 to 400,000 per microliter (or 150 - 400 x 109 per liter).|8 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 3 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 3 subjects because either the subjects missed a visit or chose not to stop therapy||count per microliter||Full Range|Mean
772854|NCT00734344|Primary|Mean Platelet Count Between Treatment Groups at 6 Months|The mean platelet count between treatment groups at 6 months after starting study drug. The calculated number of platelets in a volume of blood, usually expressed as platelets per cubic millimeter (cmm) of whole blood. Platelets are the smallest cell-like structures in the blood and are important for blood clotting and plugging damaged blood vessels. Platelet counts are usually done by laboratory machines that also count other blood elements such as the white and red cells. They can also be counted by use of a microscope. Normal platelet counts are in the range of 150,000 to 400,000 per microliter (or 150 - 400 x 109 per liter).|6 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 1 subject because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 4 subjects because either the subjects missed a visit or chose not to stop therapy||count per microliter||Full Range|Mean
772855|NCT00734344|Primary|Mean Platelet Count Between Treatment Groups at 4 Months|The mean platelet count between treatment groups at 4 months after starting study drug. The calculated number of platelets in a volume of blood, usually expressed as platelets per cubic millimeter (cmm) of whole blood. Platelets are the smallest cell-like structures in the blood and are important for blood clotting and plugging damaged blood vessels. Platelet counts are usually done by laboratory machines that also count other blood elements such as the white and red cells. They can also be counted by use of a microscope. Normal platelet counts are in the range of 150,000 to 400,000 per microliter (or 150 - 400 x 109 per liter).|4 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 1 subject because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 4 subjects because either the subjects missed a visit or chose not to stop therapy||count per microliter||Full Range|Mean
772856|NCT00734344|Primary|Mean Platelet Count Between Treatment Groups at 2 Months|The mean platelet count between treament groups at 2 months after starting study drug. The calculated number of platelets in a volume of blood, usually expressed as platelets per cubic millimeter (cmm) of whole blood. Platelets are the smallest cell-like structures in the blood and are important for blood clotting and plugging damaged blood vessels. Platelet counts are usually done by laboratory machines that also count other blood elements such as the white and red cells. They can also be counted by use of a microscope. Normal platelet counts are in the range of 150,000 to 400,000 per microliter (or 150 - 400 x 100 per liter).|2 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 1 subject because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm||count per microliter||Full Range|Mean
772857|NCT00734344|Primary|Mean Hematocrit Between Treatment Groups at 14 Months|Mean hematocrit of all subjects at 14 months after starting study drug. The hematocrit, also known as packed cell volume (PCV) or erythrocyte volume fraction (EVF), is the volume percentage (%) of red blood cells in blood. It is normally 45% for men and 40% for women.|14 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 8 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 6 subjects because either the subjects missed a visit or chose not to stop therapy||percentage||Full Range|Mean
772858|NCT00734344|Primary|Mean Hematocrit Between Treatment Groups at 12 Months|Mean hematocrit of all subjects at 12 months after starting study drug. The hematocrit, also known as packed cell volume (PCV) or erythrocyte volume fraction (EVF), is the volume percentage (%) of red blood cells in blood. It is normally 45% for men and 40% for women.|12 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 6 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 5 subjects because either the subjects missed a visit or chose not to stop therapy||percentage||Full Range|Mean
772859|NCT00734344|Primary|Mean Hematocrit Between Treatment Groups at 10 Months|Mean hematocrit of all subjects at 10 months after starting study drug. The hematocrit, also known as packed cell volume (PCV) or erythrocyte volume fraction (EVF), is the volume percentage (%) of red blood cells in blood. It is normally 45% for men and 40% for women.|10 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 7 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 7 subjects because either the subjects missed a visit or chose not to stop therapy||percentage||Full Range|Mean
772860|NCT00734344|Primary|Mean Hematocrit Between Treatment Groups at 8 Months|Mean hematocrit of all subjects at 8 months after starting study drug. The hematocrit, also known as packed cell volume (PCV) or erythrocyte volume fraction (EVF), is the volume percentage (%) of red blood cells in blood. It is normally 45% for men and 40% for women.|8 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 3 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 3 subjects because either the subjects missed a visit or chose not to stop therapy||percentage||Full Range|Mean
772861|NCT00734344|Primary|Mean Hematocrit Between Treatment Groups at 6 Months|Mean hematocrit of all subjects at 6 months after starting study drug. The hematocrit, also known as packed cell volume (PCV) or erythrocyte volume fraction (EVF), is the volume percentage (%) of red blood cells in blood. It is normally 45% for men and 40% for women.|6 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 1 subject because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 4 subjects because either the subjects missed a visit or chose not to stop therapy||percentage||Full Range|Mean
786190|NCT00833690|Secondary|Serum Urate|From blood sample drawn after taking study drug that day|Visit 02 (Week 4; 28 +/- 3 days after Baseline Visit)|||mg/dL||Standard Deviation|Mean
772862|NCT00734344|Primary|Mean Hematocrit Between Treatment Groups at 4 Months|Mean hematocrit of all subjects at 4 months after starting study drug. The hematocrit, also known as packed cell volume (PCV) or erythrocyte volume fraction (EVF), is the volume percentage (%) of red blood cells in blood. It is normally 45% for men and 40% for women.|4 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 1 subject because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 4 subjects because either the subjects missed a visit or chose not to stop therapy||percentage||Full Range|Mean
772863|NCT00734344|Primary|Mean Hematocrit Between Treatment Groups at 2 Months|Mean hematocrit of all subjects at 2 months after starting study drug. The hematocrit, also known as packed cell volume (PCV) or erythrocyte volume fraction (EVF), is the volume percentage (%) of red blood cells in blood. It is normally 45% for men and 40% for women.|2 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 1 subject because either the subject missed a visit or chose not to stop therapy||percentage||Full Range|Mean
772864|NCT00734344|Primary|Mean White Blood Cell Count Between Treatment Groups at 14 Months|Mean WBC count of all subjects as determined by standard lab procedures at 14 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL).|14 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 8 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 6 subjects because either the subjects missed a visit or chose not to stop therapy||white blood cells per microliter (mcL).||Full Range|Mean
772865|NCT00734344|Primary|Mean White Blood Cell Count Between Treatment Groups at 12 Months|Mean WBC count of all subjects as determined by standard lab procedures at 12 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL).|12 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 6 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 5 subjects because either the subjects missed a visit or chose not to stop therapy||white blood cells per microliter (mcL).||Full Range|Mean
772866|NCT00734344|Primary|Mean White Blood Cell Count Between Treatment Groups at 10 Months|Mean WBC count of all subjects as determined by standard lab procedures at 10 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL).|10 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 7 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 7 subjects because either the subjects missed a visit or chose not to stop therapy||white blood cells per microliter (mcL).||Full Range|Mean
772867|NCT00734344|Primary|Mean White Blood Cell Count Between Treatment Groups at 8 Months|Mean WBC count of all subjects as determined by standard lab procedures at 8 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL).|8 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 3 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 4 subjects because either the subjects missed a visit or chose not to stop therapy||white blood cells per microliter (mcL).||Full Range|Mean
772868|NCT00734344|Primary|Mean White Blood Cell Count Between Treatment Groups at 6 Months|Mean WBC count of all subjects as determined by standard lab procedures at 6 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL).|6 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 1 subject because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 4 subjects because either the subjects missed a visit or chose not to stop therapy||white blood cells per microliter (mcL).||Full Range|Mean
772869|NCT00734344|Primary|Mean White Blood Cell Count Between Treatment Groups at 4 Months|Mean WBC count of all subjects as determined by standard lab procedures at 4 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL).|4 months post baseline|In the Raltegravir plus Truvada arm, there was no data for 1 subject because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 3 subjects because either the subjects missed a visit or chose not to stop therapy||white blood cells per microliter (mcL).||Full Range|Mean
772870|NCT00734344|Primary|Mean White Blood Cell Count Between Treatment Groups at 2 Months|Mean WBC count for all subjects as determined by standard lab procedures at 2 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL).|baseline to 2 months|Raltegravir plus Truvada arm, there was no data for 1 subject because either the subject missed a visit or chose not to stop therapy.||white blood cells per microliter (mcL).||Full Range|Mean
772871|NCT00734409|Secondary|Mean Days on Mechanical Ventilation|The mean number of days that the patients were on mechanical ventilation.|ICU stay- through discharge|All patients who met eligibility requirements, consented for the trial, and were randomized were included in the analysis.||Days||Standard Deviation|Mean
772872|NCT00734409|Secondary|Unplanned Self-device Removal Events|The number of unplanned self-device removal events that took place during the study period.|ICU stay through discharge|All patients who met eligibility requirements, consented for the trial, and were randomized were included in the analysis.||Event|||Number
772873|NCT00734409|Primary|Mean Sedative Use|The mean amount of propofol used on each patient while the patient was in the ICU and receiving mechanical ventilation.|Intensive Care Unit (ICU) stay through discharge|All patients who met eligibility requirements, consented for the trial, and were randomized were included in the analysis.||ml/hour||Standard Deviation|Mean
772885|NCT00734474|Secondary|Change From Baseline in Pulse Rate at Dose Decision Point|Sitting pulse rate was measured at the time that the dose decision was made (dose decision point). Change from baseline in pulse rate was 1 of the 4 measures included in the clinical utility index (CUI) used to evaluate the dose decision. The maximum duration of exposure to LY2189265, Sitagliptin, or Placebo (across all treatment arms) at the decision point was 27.4 weeks.|Baseline up to 27.4 weeks|All participants randomized before the dose decision point who had evaluable sitting pulse rate data.||beats per minute (bpm)||Standard Deviation|Mean
786191|NCT00833690|Secondary|Serum Urate|From blood sample drawn after taking study drug that day|Visit 01 (Week 2; 14 +/- 3 days after Baseline Visit)|||mg/dL||Standard Deviation|Mean
772874|NCT00734474|Other Pre-specified|Number of Participants With Adjudicated Cardiovascular Events at 104 Weeks|Data on any new cardiovascular (CV) event was prospectively collected using a CV event electronic case report form. At prespecified visits, participants were asked about any new CV event. Deaths and nonfatal cardiovascular adverse events (AEs) were adjudicated by a committee of physicians with cardiology expertise external to the Sponsor. The nonfatal cardiovascular AEs to be adjudicated include myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions (such as coronary artery bypass graft or percutaneous coronary intervention), and cerebrovascular events including cerebrovascular accident (stroke) and transient ischemic attack. The number of participants with adjudicated CV events is summarized cumulatively. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 104 weeks|All randomized participants.||participants|||Number
772875|NCT00734474|Other Pre-specified|Number of Participants With Adjudicated Pancreatitis at 104 Weeks|The number of participants with pancreatitis confirmed by adjudication is summarized cumulatively. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 104 weeks|All randomized participants.||participants|||Number
772876|NCT00734474|Secondary|Antibodies to LY2189265|The number of participants with postbaseline detection of treatment-emergent antidrug LY2189265 antibodies (ADA) is summarized.|Baseline through 104 weeks|All randomized participants in the LY2189265 arms who had evaluable ADA data. If there were no data after the date of randomization, the endpoint was considered missing.||participants|||Number
772877|NCT00734474|Secondary|Pharmacokinetics of LY2189265: Area Under the Concentration-Time Curve|Pharmacokinetic (PK) parameter estimates from LY2189265 concentration data were obtained using a 2-compartment population PK model with first order absorption. Area under the plasma-concentration curve from 0 to 168 hours, steady state (AUC0-168h, ss) of LY2189265 is summarized.|Baseline through 52 weeks|Randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) who had blood samples collected for PK assessments.||nanograms times hours per milliliter||Standard Deviation|Mean
772878|NCT00734474|Secondary|Resource Utilization|The number of visits to the emergency room (ER) is summarized cumulatively.|Baseline through 52 and 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and active comparator (Sitagliptin) arms.||events|||Number
772879|NCT00734474|Secondary|Participant-reported Outcomes, EQ-5D|The EQ-5D questionnaire is a generic, multidimensional, health-related, quality-of-life instrument. It consists of 2 parts. The first part allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a three level scale of 1-3 (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension). The second part of the questionnaire consists of a 100-millimeter visual analog scale (VAS) on which the participants rated their perceived health state on that day from 0 (worst imaginable health state) to 100 (best imaginable health state).|Baseline, 52 weeks, and 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and active comparator (Sitagliptin) arms who had evaluable EQ-5D data. If there were no data after the date of randomization, the endpoint was considered missing.||units on a scale||Standard Deviation|Mean
772880|NCT00734474|Secondary|Participant-reported Outcomes, Impact of Weight on Quality of Life-Lite (IWQoL-Lite)|The Impact of Weight on Quality of Life-Lite (IWQoL-Lite questionnaire) is an obesity-specific, 31-item questionnaire designed to measure the impact of weight on participants’ quality of life. Items are scored on a 5-point numeric rating scale where 5 = “always true” and 1 = “never true”. Items are summed into 6 scales (physical function [11 items], self-esteem [7 items], sexual life [4 items], public distress [5 items], work [4 items], and total score [31 items]) based on the average for the valid responses on that scale multiplied by the number of items on that scale (rounded to the nearest whole integer). Higher scores indicate lower levels of functioning (negative effects). Scores are linearly transformed to a 0 to 100 scale.|Baseline, 52 weeks, and 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and active comparator (Sitagliptin) arms who had evaluable IWQoL-Lite data. If there were no data after the date of randomization, the endpoint was considered missing.||units on a scale||Standard Deviation|Mean
772881|NCT00734474|Secondary|Change From Baseline in Electrocardiogram (ECG) Parameters, Fridericia-corrected QT (QTcF) and PR Interval|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. PR is the interval between the P wave and the QRS complex. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26 weeks, 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms who had evaluable ECG data. If there were no data after the date of randomization, the endpoint was considered missing.||milliseconds (msec)||Standard Error|Least Squares Mean
772882|NCT00734474|Secondary|Change From Baseline in Blood Pressure|Sitting and standing systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured. Least squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26 weeks, 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms who had evaluable SBP and DBP data. If there were no data after the date of randomization, the endpoint was considered missing.||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
772883|NCT00734474|Secondary|Change From Baseline in Pulse Rate|Sitting and standing pulse rate were measured. Least squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as covariate.|Baseline, 26 weeks, 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms who had evaluable pulse data. If there were no data after the date of randomization, the endpoint was considered missing.||beats per minute (bpm)||Standard Error|Least Squares Mean
772886|NCT00734474|Secondary|Number of Participants With Treatment-emergent Abnormal Lipid Tests|The number of participants with treatment-emergent abnormal lipid test (cholesterol, high density lipoprotein cholesterol [HDL-C], low density lipoprotein cholesterol [LDL-C], and triglycerides [TG]) results (defined as lipid test abnormalities that first occurred after baseline) is summarized cumulatively.|Baseline through 26 and 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms with baseline value not in the specified direction of treatment-emergent abnormality and at least 1 postbaseline result.||participants|||Number
772887|NCT00734474|Secondary|Number of Participants With Treatment-emergent Abnormal Laboratory Tests at 104 Weeks|The number of participants with treatment-emergent abnormal laboratory results (defined as abnormalities that first occur after baseline) was summarized cumulatively for alkaline phosphatase, alanine aminotransferase or serum glutamic pyruvic transaminase (ALT/SGPT), amylase (pancreatic and total), aspartate aminotransferase or serum glutamic oxaloacetic transaminase (AST/SGOT), basophils, bilirubin (direct and total), calcitonin, chloride, creatine phosphokinase (CPK), creatinine, creatinine clearance, eosinophils, erythrocytes, gamma glutamyltransferase (GGT), hematocrit, hemoglobin, leukocytes, lipase, lymphocytes, mean cell hemoglobin concentration (MCHC), mean cell volume (MCV), monocytes, neutrophils, platelets, potassium, sodium, urea nitrogen, and urine microalbumin-to-creatinine ratio (UMCR).|Baseline through 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and active comparator (Sitagliptin) arms with baseline value not in the specified direction of treatment-emergent abnormality and at least 1 postbaseline result.||participants|||Number
772888|NCT00734474|Secondary|Number of Participants With Treatment-emergent Abnormal Laboratory Tests at 52 Weeks|The number of participants with treatment-emergent abnormal laboratory results (defined as abnormalities that first occur after baseline) was summarized cumulatively for alkaline phosphatase, alanine aminotransferase or serum glutamic pyruvic transaminase (ALT/SGPT), amylase (pancreatic and total), aspartate aminotransferase or serum glutamic oxaloacetic transaminase (AST/SGOT), basophils, bilirubin (direct and total), calcitonin, chloride, creatine phosphokinase (CPK), creatinine, creatinine clearance, eosinophils, erythrocytes, gamma glutamyltransferase (GGT), hematocrit, hemoglobin, leukocytes, lipase, lymphocytes, mean cell hemoglobin concentration (MCHC), mean cell volume (MCV), monocytes, neutrophils, platelets, potassium, sodium, urea nitrogen, and urine microalbumin-to-creatinine ratio (UMCR) .|Baseline through 52 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and active comparator (Sitagliptin) arms with baseline value not in the specified direction of treatment-emergent abnormality and at least 1 postbaseline result.||participants|||Number
772889|NCT00734474|Secondary|Number of Participants With Treatment-emergent Abnormal Laboratory Tests at 26 Weeks|The number of participants with treatment-emergent abnormal laboratory results (defined as abnormalities that first occur after baseline) was summarized cumulatively for alkaline phosphatase, alanine aminotransferase or serum glutamic pyruvic transaminase (ALT/SGPT), amylase (pancreatic and total), aspartate aminotransferase or serum glutamic oxaloacetic transaminase (AST/SGOT), basophils, bilirubin (direct and total), calcitonin, chloride, creatine phosphokinase (CPK), creatinine, creatinine clearance, eosinophils, erythrocytes, gamma glutamyltransferase (GGT), hematocrit, hemoglobin, leukocytes, lipase, lymphocytes, mean cell hemoglobin concentration (MCHC), mean cell volume (MCV), monocytes, neutrophils, platelets, potassium, sodium, urea nitrogen, and urine microalbumin-to-creatinine ratio (UMCR).|Baseline through 26 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms with baseline value not in the specified direction of treatment-emergent abnormality and at least 1 postbaseline result.||participants|||Number
772890|NCT00734474|Secondary|Number of Participants With Treatment-emergent Adverse Events at 104 Weeks|A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with 1 or more TEAEs is summarized cumulatively. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and active comparator (Sitagliptin) arms.||participants|||Number
772891|NCT00734474|Secondary|Number of Participants With Treatment-emergent Adverse Events at 52 Weeks|A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with 1 or more TEAEs is summarized cumulatively. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 52 weeks|All randomized participants in the LY2189265 and active comparator (Sitagliptin) arms.||participants|||Number
772892|NCT00734474|Secondary|Number of Participants With Treatment-emergent Adverse Events at 26 Weeks|A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with 1 or more TEAEs is summarized cumulatively. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms.||participants|||Number
772893|NCT00734474|Secondary|Beta Cell Function and Insulin Sensitivity (HOMA2)|The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance and beta (β)-cell function. HOMA2-%B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state beta cell function (%B) as a percentage of a normal reference population (normal young adults). HOMA2-%S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S), as percentages of a normal reference population (normal young adults). The normal reference population for both HOMA2-%B and HOMA2-%S were set at 100%. Least squares (LS) means of change from baseline of C-peptide based HOMA2-%B and HOMA2-%S were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26, 52, and 104 weeks|All participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms randomized after the dose decision point and who had evaluable HOMA2 data. If there were no data after the date of randomization, the endpoint was considered missing.||HOMA2-%||Standard Error|Least Squares Mean
772894|NCT00734474|Secondary|Rate of Hypoglycemic Episodes|Hypoglycemic episodes (HE) were classified as severe (defined as episodes requiring assistance from another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia and has a plasma glucose level of ≤3.9 millimoles per liter [mmol/L]), asymptomatic (defined as episodes not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of ≤3.9 mmol/L), nocturnal (defined as any episode that occurred between bedtime and waking), or probable symptomatic (defined as episodes during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The 1-year adjusted rate of HE is summarized cumulatively.|Baseline through 26 and 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms.||episodes per participant per year||Standard Deviation|Mean
772895|NCT00734474|Secondary|Incidence of Hypoglycemic Episodes|Hypoglycemic episodes (HE) were classified as severe (defined as episodes requiring assistance from another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia and has a plasma glucose level of ≤3.9 millimoles per liter [mmol/L]), asymptomatic (defined as episodes not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of ≤3.9 mmol/L), nocturnal (defined as any episode that occurred between bedtime and waking), or probable symptomatic (defined as episodes during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The number of participants with self-reported hypoglycemic events is summarized cumulatively.|Baseline through 26 and 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms.||participants|||Number
772896|NCT00734474|Secondary|Percentage of Participants Who Achieve Glycosylated Hemoglobin (HbA1c) <7% or ≤6.5%|The percentage of participants achieving HbA1c levels <7.0% and ≤6.5% was analyzed using a logistic regression model and last observation carried forward (LOCF) imputation with baseline, country, and treatment as factors included in the model.|Baseline, 26, 52, and 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms who had evaluable HbA1c data. Last observation carried forward was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||percentage of participants|||Number
772897|NCT00734474|Secondary|Waist Circumference Change From Baseline|Least squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26, 52, and 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms who had evaluable waist circumference data. If there were no data after the date of randomization, the endpoint was considered missing.||centimeters (cm)||Standard Error|Least Squares Mean
772898|NCT00734474|Secondary|Durability of Change From Baseline Body Weight|Durability of effect on body weight was assessed by comparing the differences in mean change from baseline in body weight at 1 time point versus an earlier time point. Least squares (LS) means of change from baseline body weight data were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 13, 26, 52, and 104 weeks|All participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms randomized after the dose decision point who had evaluable body weight data. If there were no data after the date of randomization, the endpoint was considered missing.||kilograms (kg)||Standard Error|Least Squares Mean
772899|NCT00734474|Secondary|Body Weight Change From Baseline|Least squares (LS) means of change from baseline body weight were calculated using analysis of covariance (ANCOVA) and last observation carried forward (LOCF) imputation with country and treatment as fixed effects and baseline as a covariate.|Baseline, 26, 52, and 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms who had evaluable body weight data. Last observation carried forward was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||kilograms (kg)||Standard Error|Least Squares Mean
772900|NCT00734474|Secondary|Change From Baseline in Body Weight at Dose Decision Point|Change from baseline in body weight was 1 of the 4 measures included in the clinical utility index (CUI) used to evaluate the dose decision. The maximum duration of exposure to LY2189265, Sitagliptin, or Placebo (across all treatment arms) at the decision point was 27.4 weeks.|Baseline up to 27.4 weeks|All participants randomized before the dose decision point who had evaluable body weight data.||kilograms (kg)||Standard Deviation|Mean
772901|NCT00734474|Secondary|Fasting Insulin Change From Baseline|Least squares (LS) means of change from baseline fasting insulin data were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26, 52, and 104 weeks|All participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms randomized after the dose decision point who had evaluable fasting insulin data. If there were no data after the date of randomization, the endpoint was considered missing.||picomoles per liter (pmol/L)||Standard Error|Least Squares Mean
772902|NCT00734474|Secondary|Fasting Blood Glucose Change From Baseline|Least squares (LS) means of change from baseline were calculated using mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26, 52, and 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms who had evaluable fasting plasma glucose data. If there were no data after the date of randomization, the endpoint was considered missing.||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
772922|NCT00734578|Secondary|Change From Baseline in Before School Functioning Questionnaire (BSFQ) at Week 8 - LOCF|This scale was designed to assess symptoms of ADHD that typically occur in the morning. The BSFQ consists of two components. The first, a 20-item scale with ratings from 0 (none) to 3 (severe) with a range of 0-60 followed by two questions answered with duration of time (in minutes). The second, a 14-item scale with ratings from 0 (no) to 2 (a lot) with a range of 0-28. The results reported here are from the 20-item scale. Lower scores are better.|Baseline and weekly up to 8 weeks|FAS||Units on a scale||Standard Deviation|Mean
772903|NCT00734474|Secondary|Durability of Change From Baseline in Glycosylated Hemoglobin (HbA1c)|Durability of effect on HbA1c was assessed by comparing the differences in mean change from baseline in HbA1c at 1 time point versus an earlier time point. Least squares (LS) means of change from baseline HbA1c data were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 13, 26, 52, and 104 weeks|All participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms randomized after the dose decision point who had evaluable HbA1c data. If there were no data after the date of randomization, the endpoint was considered missing.||percentage of HbA1c||Standard Error|Least Squares Mean
772904|NCT00734474|Secondary|Glycosylated Hemoglobin (HbA1c) Change From Baseline|Least squares (LS) means were calculated using analysis of covariance (ANCOVA) and last observation carried forward (LOCF) imputation with country and treatment as fixed effects and baseline HbA1c as a covariate.|Baseline, 26 weeks, 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms who had evaluable HbA1c data. Last observation carried forward was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||percentage of HbA1c||Standard Error|Least Squares Mean
772905|NCT00734474|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at the Dose Decision Point|Change from baseline in HbA1c was 1 of the 4 measures included in the clinical utility index (CUI) used to evaluate the dose decision. The maximum duration of exposure to LY2189265, Sitagliptin, or Placebo (across all treatment arms) at the decision point was 27.4 weeks.|Baseline up to 27.4 weeks|All participants randomized before the dose decision point who had evaluable HbA1c data.||percentage of HbA1c||Standard Deviation|Mean
772906|NCT00734474|Primary|Glycosylated Hemoglobin (HbA1c) Change From Baseline|Least squares (LS) means were calculated using analysis of covariance (ANCOVA) and last observation carried forward (LOCF) imputation with country and treatment as fixed effects and baseline HbA1c as a covariate.|Baseline, 52 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and active comparator (Sitagliptin) arms who had evaluable HbA1c data. Last observation carried forward was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||percentage of HbA1c||Standard Error|Least Squares Mean
772907|NCT00734500|Secondary|Safety (Participants With Adverse Events) of Anidulafungin in Infants and Toddlers Less Than 24 Months of Age With Suspected Serious Infection.|Participants with Adverse events were collected during the study drug administration phase up to 10 days after last dose of study drug.|During and up to 10 days after last dose of study drug.|||participants|||Number
772908|NCT00734500|Primary|The Pharmacokinetics (Area Under the Curve) of Anidulafungin in Infants and Toddlers Less Than 24 Months of Age With Suspected Serious Infection.|Area under the curve at steady state|5 days|||µg*h/mL||Full Range|Median
772921|NCT00734578|Secondary|Post Sleep Questionnaire (PSQ) Quality of Sleep at Week 8 - LOCF|Post Sleep Questionnaire (PSQ) overall rating of quality of sleep. There are 5 rating responses ranging from very poor to very good. No numbers are associated with the rating responses.|Baseline and weekly up to 8 weeks|FAS||Percent of participants|||Number
772923|NCT00734578|Secondary|Change From Baseline in the Oppositional Subscale of the Conners' Parent Rating Scale-Revised Long Form (CPRS-R:L) Score at Week 8 - LOCF|The oppositional subscale of the CPRS-R:L contains 10 items designed to reflect criteria for oppositional defiance disorder (ODD). Each item is scored on a range from 0 (not true at all) to 3 (very much true) with total scores ranging from 0 to 30. Higher scores are reflective of more severe symptoms.|Baseline and weekly up to 8 weeks|FAS||Units on a scale||Standard Deviation|Mean
772925|NCT00734578|Secondary|Change From Baseline in Conners' Global Index - Parent (CGI-P) Total Score at Week 8 - LOCF: Evening Assessment (Before Bedtime)|The index contains 10 items. Each item on the scale is scored from a range of 0 (reflecting never, seldom) to 3 (reflecting very often, very frequent) with total scores ranging from 0 30.|Baseline and weekly up to 8 weeks|FAS||Units on a scale||Standard Deviation|Mean
772926|NCT00734578|Secondary|Change From Baseline in Conners’ Global Index – Parent (CGI-P) Total Score at Week 8 - LOCF: Morning Assessment (Before School)|The index contains 10 items. Each item on the scale is scored from a range of 0 (reflecting never, seldom) to 3 (reflecting very often, very frequent) with total scores ranging from 0 to 30.|Baseline and weekly up to 8 weeks|FAS||Units on a scale||Standard Deviation|Mean
772927|NCT00734578|Secondary|Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|Baseline and weekly up to 8 weeks|FAS||Percent of participants|||Number
772928|NCT00734578|Secondary|Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) at Week 8 - LOCF|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|Baseline and weekly up to 8 weeks|FAS||Percent of participants|||Number
772929|NCT00734578|Primary|Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Week 8 - Last Observation Carried Forward (LOCF)|The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|Baseline and weekly up to 8 weeks|Full Analysis Set (FAS) which includes all subjects who received at least 1 dose of any study drug during this study.||Units on a scale||Standard Deviation|Mean
772930|NCT00734591|Secondary|Rate of Primary Lung Cancer Diagnosis|The rate and rate ratio of lung cancer adjudicated as highly likely (clinical, radiographic, and/or histological data consistent with primary lung cancer) or likely (some information may have been missing for definite diagnosis) to be newly diagnosed primary lung cancer that occurred anytime from the start of the original trial to the end of FUSE.|Baseline from original trial up to Year 2 of this study|Entire study population||Lung Cancer per 1000 PY||95% Confidence Interval|Number
772931|NCT00734591|Secondary|Rate of All-cause Mortality|The rate and rate ratio of all-cause mortality that occurred anytime from the start of the original trial to the end of FUSE.|Baseline from original trial up to Year 2 of this study|Entire study population||Deaths per 1000 PY||95% Confidence Interval|Number
772932|NCT00734591|Secondary|Rate of Primary Lung Cancer Mortality Among Former Smokers|Reported deaths from primary lung cancer were adjudicated and classified into 4 categories: highly likely (clinical, radiographic, and/or histological data consistent with primary lung cancer); likely (some information may have been missing for definite diagnosis); unlikely; insufficient information. Highly likely and likely cases used to report rate and rate ratio of primary lung cancer mortality. Includes events from the start of the original trial to the end of FUSE.|Baseline from original trial up to Year 2 of this study|Subset of the entire study population who were former smokers.||Deaths per 1000 PY||95% Confidence Interval|Number
772933|NCT00734591|Primary|Rate of Primary Lung Cancer Mortality|Reported deaths from primary lung cancer were adjudicated and classified into 4 categories: highly likely (clinical, radiographic, and/or histological data consistent with primary lung cancer); likely (some information may have been missing for definite diagnosis); unlikely; insufficient information. Highly likely and likely cases used to report rate and rate ratio of primary lung cancer mortality. Includes events from the start of the original trial to the end of FUSE.|Baseline from original trial up to Year 2 of this study|Entire study population: all randomized participants (retrospective).||Deaths per 1000 patient years (PY)||95% Confidence Interval|Number
772934|NCT00734604|Secondary|"Question 4 I Felt Like a Whole Man Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint"|Scores for Question 4 range from 0 (not at all) to 4 (extremely).|8 weeks of each treatment|||units on a scale||Standard Deviation|Mean
772935|NCT00734604|Secondary|"Question 3 I Felt the Drug Was in Control of my Erections Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint"|Scores for Question 3 range from 0 (not at all) to 4 (extremely).|8 weeks of each treatment|||units on a scale||Standard Deviation|Mean
772936|NCT00734604|Secondary|"Question 2 I Felt in Control of my Sex Life Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint"|Scores for Question 2 range from 0 (not at all) to 4 (extremely).|8 weeks of each treatment|||units on a scale||Standard Deviation|Mean
772937|NCT00734604|Secondary|"Question 1 I Felt as if I Did Not Have ED Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint"|Scores for Question 1 range from 0 (not at all) to 4 (extremely).|8 weeks of each treatment|||units on a scale||Standard Deviation|Mean
772938|NCT00734604|Secondary|Change From Baseline to Endpoint in the Self-Esteem And Relationship (SEAR) Questionnaire Transformed Total Score|Measures improvement in self-esteem and relationship satisfaction. Questionnaire consists of two domains, Sexual Relationship (items 1–8) and Confidence (items 9–14). Overall score is transformed onto a 0 (least favorable) to 100 (most favorable) scale. Overall score was calculated from two domains and subscales scores.|baseline, 8 weeks of each treatment|||units on a scale||Standard Deviation|Mean
772939|NCT00734604|Secondary|Number of Participants With at Least One Serious Adverse Event|Serious adverse events are listed in the Reported Adverse Event module.|baseline through 26 weeks (including two washout periods of 1 week each)|||participants|||Number
772940|NCT00734604|Secondary|Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Score at Endpoint|EDITS is a questionnaire-based inventory capturing a participant's subjective evaluation of treatment for the participant's erection problems. All items on the 11-item Patient EDITS were scored from zero (no satisfaction or dissatisfaction) to four (high satisfaction). The EDITS Summary Score (transformed) is obtained by adding each individual score for all questions, dividing by the number of questions, and multiplying by 25, so that EDITS scores could range from a low of 0 (extremely low treatment satisfaction) to a high of 100 (extremely high treatment satisfaction).|8 weeks of each treatment|||units on a scale||Standard Deviation|Mean
772987|NCT00734968|Primary|Incidence of Post-operative UTI Following the Placement of Sub-urethral Sling for the Treatment of Stress Urinary Incontinence|The overall rate of UTI following the placement of sub-urethral sling for the treatment of stress urinary incontinence in our study was 24.8% (n = 37)|6 weeks|||participants|||Number
772941|NCT00734604|Secondary|Change From Baseline to Endpoint in the Overall Satisfaction (OS) Domain of the IIEF|Self-reported overall satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 2 questions of the IIEF-OS domain range from 0 to 10.|baseline, 8 weeks of each treatment|||units on a scale||Standard Deviation|Mean
772942|NCT00734604|Secondary|Change From Baseline to Endpoint in the Intercourse Satisfaction (IS) Domain of the IIEF|Self-reported intercourse satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 3 questions of the IIEF-IS domain range from 0 to 15.|baseline, 8 weeks of each treatment|||units on a scale||Standard Deviation|Mean
772943|NCT00734604|Secondary|Change From Baseline to Endpoint in the Proportion of Days With at Least One Morning Erection||baseline, 8 weeks of each treatment|||proportion of days||Standard Deviation|Mean
772944|NCT00734604|Secondary|Change From Baseline to Endpoint in the Erectile Function Domain of the International Index of Erectile Function (IIEF)|Self-reported erectile function over the past 4 weeks. Scores range from 0 (low or no erectile function) to 5 (high erectile function) on 6 questions (1-5, 15 of the IIEF). Total Erectile Function Domain scores range from 0 to 30.|baseline, 8 weeks of each treatment|||units on a scale||Standard Deviation|Mean
772945|NCT00734604|Secondary|Change From Baseline to Endpoint in the Time Concerns Domain of PAIRS|The PAIRS is a self-administed scale that assesses the broader psychological and interpersonal outcomes associated with erectile dysfunction and its treatment. Time Concerns score is the average of responses on 8 PAIRS item scores. Time Concerns scores range from 1 (strongly disagree) to 4 (strongly agree). Higher scores are indicative of greater sexual self-confidence.|baseline, 8 weeks of each treatment|||units on a scale||Standard Deviation|Mean
772946|NCT00734604|Secondary|Change From Baseline to Endpoint in the Spontaneity Domain of PAIRS|The PAIRS is a self-administed scale that assesses the broader psychological and interpersonal outcomes associated with erectile dysfunction and its treatment. Spontaneity score is the average of responses on 9 PAIRS item scores. Spontaneity scores range from 1 (strongly disagree) to 4 (strongly agree). Higher scores are indicative of greater spontaneity.|baseline, 8 weeks of each treatment|||units on a scale||Standard Deviation|Mean
772947|NCT00734604|Secondary|Change From Baseline Between Tadalafil Once a Day (OaD) and Tadalafil as Needed (PRN) in Sexual Self-Confidence Domain of Psychological and Interpersonal Relationship Scales (PAIRS)|The PAIRS is a self-administed scale that assesses the broader psychological and interpersonal outcomes associated with erectile dysfunction and its treatment. Sexual Self-Confidence score is the average of responses on 6 PAIRS item scores. Sexual Self-Confidence scores range from 1 (strongly disagree) to 4 (strongly agree). Higher scores are indicative of greater sexual self-confidence.|baseline, 8 weeks of each treatment|||units on a scale||Standard Deviation|Mean
772948|NCT00734604|Primary|Change From Baseline Between Tadalafil Once a Day (OaD) and Sildenafil as Needed (PRN) in Sexual Self-Confidence Domain of Psychological and Interpersonal Relationship Scales (PAIRS)|The PAIRS is a self-administed scale that assesses the broader psychological and interpersonal outcomes associated with erectile dysfunction and its treatment. Sexual Self-Confidence score is the average of responses on 6 PAIRS item scores. Sexual Self-Confidence scores range from 1 (strongly disagree) to 4 (strongly agree). Higher scores are indicative of greater sexual self-confidence.|baseline, 8 weeks of each treatment|||units on a scale||Standard Deviation|Mean
772949|NCT00734617|Primary|Continuous Abstinence From Smoking at Ten Weeks Post-quit|Continuous abstinence from the target quit date through the end of treatment (10 weeks) was assessed based on self reports of continuous abstinence (i.e., no lapses) that were confirmed by end-expired CO levels ≤ 10 ppm.|May 2009|||participants|||Number
772950|NCT00734630|Secondary|Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) at Week 12|Change from Baseline in Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) at Week 12, Last Observation Carried Forward (LOCF).|From baseline Visit 5 (Week 0) to Visit 10 (Week 12)|||mmHG||Standard Deviation|Mean
772951|NCT00734630|Primary|Mean Seated Trough Cuff Systolic Blood Pressure (SBP) at Week 12|Change from Baseline in Mean Seated Trough Cuff Systolic Blood Pressure (SBP) at Week 12, Last Observation Carried Forward (LOCF).|From baseline Visit 5 (Week 0) to Visit 10 (Week 12)|||mmHG||Standard Deviation|Mean
772952|NCT00734656|Secondary|Change in Serum 3a-androstanediol Glucuronide|Ratio of serum 3a-androstanediol drawn prior to alcohol administration (2-4 days after medication administration) compared to the baseline level prior to medication dose. The pharmacologic effect of dutasteride was measured by assay of serum 5a-androstan-3a,17b-diol,17-glucuronide (aka 3a-androstanediol glucuronide) as a biochemical measure of 5a-reductase enzyme inhibition. 3a-androstanediol glucuronide is the primary metabolic excretion product of 3a,5a-androstane neuroactive steroids. The|Baseline (pre medication administration) and 2-4 days post-medication (alcohol session)|Subjects who completed all 4 arms of study (e.g. completed each combination of dutasteride or placebo paired with 0.8 gr/kg ethanol or alcohol flavor mask)less 3 subjects removed during data cleaning due to pharmacy errors (n=2) or protocol deviation (n=1)resulted in 70 subjects completing each condition for analysis.||ratio||Standard Error|Mean
772953|NCT00734656|Primary|BAES Stimulation Response, Average of 6 Time Points|Biphasic Alcohol Effects Scale (BAES)Simulation items - sum of subjective responses - 0(not at all)to 10 (extremely)- for 7 stimulation related questions regarding effects of alcohol. Total BAES stimulation subscale score 0-70 with higher numbers indicating greater stimulating effects of alcohol. [Martin, C. S., M. Earleywine, R. E. Musty, M. W. Perrine and R. M. Swift (1993a). Development and validation of the Biphasic Alcohol Effects Scale. Alcohol Clin Exp Res 17(1): 140-6.]|40, 80, 120, 160, 210 and 240 minutes after start of drinking|Subjects who completed all 4 arms of study (e.g. completed each combination of dutasteride or placebo paired with 0.8 gr/kg ethanol or alcohol flavor mask)less 3 subjects removed during data cleaning due to pharmacy errors (n=2) or protocol deviation (n=1)resulted in 70 subjects completing each condition for analysis.||units on a scale||Standard Error|Mean
772965|NCT00734799|Primary|Insomnia Severity|Insomnia severity was assessed using the Insomnia Severity Index (ISI). The ISI is a 7-item questionnaire that provides a global measure of perceived insomnia severity. Each item is rated on a 5-point Likert scale, and the total score ranges from 0-28. The following guidelines are recommended for interpreting the total score: 0-7 (no clinical insomnia), 8-14 (subthreshold insomnia), 15-21 (insomnia of moderate severity), and 22-28 (severe insomnia). The ISI was used to determine treatment eligibility, to assess treatment outcome, and to determine clinical significance of study findings. Participants were assessed at baseline and following a 12-week intervention period.|12-weeks after Baseline|Intent to treat and completed were both reported. Data on completers reported here.||ISI Score||Standard Error|Mean
772954|NCT00734656|Primary|BAES Sedation Response, Average of 6 Time Points|Biphasic Alcohol Effects Scale (BAES) Sedation items - sum of subjective responses - 0(not at all)to 10 (extremely)- for 7 sedation related questions regarding effects of alcohol. Total BAES sedation subscale score 0-70 with higher numbers indicating greater sedative effects of alcohol. [Martin, C. S., M. Earleywine, R. E. Musty, M. W. Perrine and R. M. Swift (1993a). Development and validation of the Biphasic Alcohol Effects Scale. Alcohol Clin Exp Res 17(1): 140-6.]|40, 80, 120, 160, 210 and 240 minutes after start of drinking|Subjects who completed all 4 arms of study (e.g. completed each combination of dutasteride or placebo paired with 0.8 gr/kg ethanol or alcohol flavor mask)less 3 subjects removed during data cleaning due to pharmacy errors (n=2) or protocol deviation (n=1)resulted in 70 subjects completing each condition for analysis.||units on a scale||Standard Error|Mean
772955|NCT00734656|Primary|Breath Alcohol|Breath Alcohol level|40 minutes after beginning drink|Subjects who completed all 4 arms of study (e.g. completed each combination of dutasteride or placebo paired with 0.8 gr/kg ethanol or alcohol flavor mask)less 3 subjects removed during data cleaning due to pharmacy errors (n=2) or protocol deviation (n=1)resulted in 70 subjects completing each condition for analysis.||gr/dL||Standard Error|Mean
772956|NCT00734734|Primary|Number of Participants Who Reported Solicited Local and Systemic Reactions|Safety was assessed for participants who reported solicited local and systemic reactions from day 0 up to and including day 3 after the FLUAD vaccination.|0 to 3 days post-vaccination|Analysis was done using the safety dataset; participants in the exposed population who provided post-vaccination safety data.||Number of participants|||Number
772957|NCT00734734|Primary|Percentage of Participants Who Achieved SRH Area ≥25mm2 Against Each of the Three Vaccine Strains After One Vaccination of FLUAD|"Immunogenicity was measured as the percentage of participants achieving SRH area ≥25 mm2 against each of the three vaccine strains at baseline (day 0) and three weeks after FLUAD vaccination (day 21).
This criterion is met according to CHMP guideline if percentage of participants achieving SRH area ≥25 mm2 is 60% (≥65 years)."|day 21|Analysis was done using PP set.||Percentage of participants||95% Confidence Interval|Number
772958|NCT00734734|Primary|Geometric Mean Ratio of Participants Against Each of the Three Vaccine Strains After One Vaccination of FLUAD|"Geometric mean ratio (GMR) of participants was calculated as the ratio of post-vaccination to pre-vaccination SRH geometric mean areas (GMAs), directed against each of the three vaccine strains, three weeks after FLUAD vaccination (day 21).
The CHMP criterion was met if the geometric mean increase (GMR, day 21/day 0) in SRH antibody area is >2.0 (≥65 years)."|day 21|Analysis was done using PP set.||Ratio||95% Confidence Interval|Geometric Mean
772959|NCT00734734|Primary|Percentage of Participants Who Achieved Seroconversion or Significant Increase in Single Radial Hemolysis (SRH) Area Against Each of Three Vaccine Strains After One Vaccination of FLUAD|"Immunogenicity was measured as the percentage of participants who achieved seroconversion or significant increase in single radial hemolysis (SRH) area, against each of the three vaccine strains, three weeks after vaccination (day 21), evaluated using SRH assay.
Seroconversion: proportion of participants with negative pre-vaccination serum and a post-vaccination serum area ≥ 25 mm2. Significant increase: proportion of participants with at least a 50% increase in area from positive pre-vaccination serum. Seroconversion or significant increase: proportion of participants with either seroconversion or significant increase.
The European (Committee for Medicinal Products for Human Use [CHMP]) criterion is met, if percentage of participants achieving seroconversion or significant increase in SRH area is 30% (≥65 years)."|day 21|Per protocol (PP) analysis set included all enrolled participants who had received the relevant dose of vaccine correctly on Day 0, provided evaluable serum samples with the relevant time windows, and had no major protocol violations.||Percentage of participants||95% Confidence Interval|Number
772960|NCT00734747|Secondary|Reduction of Proton Pump Inhibitor (PPI) Use, as Reported by Subject||6 months|Note: 1 of the 66 participants was not taking proton pump inhibitors (PPIs) at baseline, therefore they were excluded from the analysis of PPI use reduction.||percentage of subjects||95% Confidence Interval|Number
772961|NCT00734747|Secondary|Reduction of Acid Exposure (%Time pH<4) on Off PPI Ambulatory 24h Acid Exposure Test|Esophageal pH (off PPI therapy) was measured in 66 patients pre-procedure and 64 patients at 6 months post-procedure|6 months|||percentage of time pH <4.0||Standard Deviation|Mean
772962|NCT00734747|Primary|Serious Adverse Events (SAEs)|The primary safety endpoint consisted of all treatment-related adverse events, during and after the SRS procedure. The primary safety endpoint consisted of all treatment-related adverse events, during and after the SRS procedure. “Treatment-related” events were conventionally defined as those which occurred in the first 30 days post-procedure. The SAEs presented here include all SAEs from the study, including one that occurred 35 days post-procedure (suicidal behavior). There was an interim review of early Serious Adverse Events (SAEs) after the first 24 patients. Protocol and device changes were then implemented, prior to the final 48 patients. Therefore, the SAEs are presented in two categories consisting of the first 24 patients and the final 48 patients.|6 months|||participants|||Number
772963|NCT00734747|Primary|Percentage of Participants With >= 50% Improvement in GERD Health Related Quality of Life (GERD-HRQL - Velanovich) Score|Gastroesophageal Reflux Disease Health Related Quality of Life (GERD-HRQL) questionnaire, also known as Velanovich score. The questionnaire consists of 10 questions with responses of 0-5. The responses of the 10 questions are totaled (range of 0-50) where a higher total indicates more severe disease than a lower total. This questionnaire was administered while the subjects were not taking proton pump inhibitor (PPI) medication (i.e. off-PPI). Criterion for success was an improvement >= 50% compared to baseline, at six months post procedure in at least 53% of the subjects (53% is the lower boundary of the 95% confidence interval)|Six months|||percentage of total participants||95% Confidence Interval|Number
772964|NCT00734799|Secondary|Nightmare Frequency|Nightmare frequency was assessed using an electronic sleep diary. Diary data was collected for a period of 1 week at both baseline and 12 weeks after baseline. The number and severity of nightmares over a 1-week period were obtained using a hand-held computer (PDA) containing an interactive program that automates the collection of subjective sleep data. The PDA device was programmed to elicit daily responses from participants and electronically record multiple days of subjective sleep information, in addition to the number and severity of nightmares for the previous night. Nightmare frequency (number of nightmares per night) was one of five variables collected from electronic sleep diaries.|12 weeks after Baseline|||Nightmare frequency per night||Standard Error|Mean
772982|NCT00734929|Secondary|Incidence of Vomiting (Post OP)||Post OP (0 - 2 hours)|||participants|||Number
772966|NCT00734851|Secondary|Comparison of RNA Expression Profile From Original Prostate Radical Prostatectomy Specimen Among Those With PSA Relapse at 2 and 3 Years as Compared to Those Without PSA Relapse at the Primary Endpoint.|Prospective collection of prostate tissue at the time of radical prostatectomy is routinely performed at Duke. These samples will be analyzed by laser capture microdissection (LCM) for genomic profiling by RNA expression analysis for all subjects with tissue available. The expression profiles of subjects who experience PSA recurrence after protocol therapy by the 24 month endpoint will be compared with the expression profiles of subjects without recurrence at this time point as an exploratory measure to predict aggressive prostate cancer and those subjects who are unlikely to benefit from this approach. Baseline prostate tumor biomarkers in the form of RNA expression profiles will be correlated with 2 year PFS in an exploratory analysis. The median bPFS of those with detectable biomarker expression is reported.|2 and 3 years|Due to the unavailability of tissue, this outcome was not performed.|||||
772967|NCT00734851|Secondary|Change in Quality of Life (QoL) After 3 Month|A validated scale of prostate-cancer specific quality of life will be measured using the Expanded Prostate Cancer Index Composite (EPIC) short form survey. This survey is standardized into subscale, 4 of which were examined on this study. These subscales are the urinary irritative domain, urinary incontinence domain, bowel domain, and sexual function domain, each standardized on a scale of 0-100, where higher score indicate a higher level of QoL. The survey was performed at baseline and 3 months after completing radiotherapy. Negative values indicate a decrease in QoL, while positive numbers represent an increase.|baseline and 3 months|Only participant who adequately completed the sub-section of each questionnaire are included in the analysis population. Some participants did not answer a sufficient number of questions to adequately score a domain and therefore were not included.||units on a scale||Full Range|Median
772968|NCT00734851|Secondary|Change in Quality of Life (QoL) After 1 Year|A validated scale of prostate-cancer specific quality of life will be measured using the Expanded Prostate Cancer Index Composite (EPIC) short form survey. This survey is standardized into subscale, 4 of which were examined on this study. These subscales are the urinary irritative domain, urinary incontinence domain, bowel domain, and sexual function domain, each standardized on a scale of 0-100, where higher score indicate a higher level of QoL. The survey was performed at baseline, at 3 months after completing radiotherapy, at 12 months, and at 2 and 3 years of follow-up for a total of 5 possible surveys per patient. Due to a low number of completed surveys at the fourth and fifth time point, the difference between the 12 month time point and baseline is summarized. Negative values indicate a decrease in QoL, while positive numbers represent an increase.|baseline and 1 year|Only participant who adequately completed the sub-section of each questionnaire are included in the analysis population. Some participants did not answer a sufficient number of questions to adequately score a domain and therefore were not included.||units on a scale||Full Range|Median
772969|NCT00734851|Secondary|Metastasis-free Survival (MFS) Rates at 2 and 3 Years.|MFS is defined as the length of time between the date of start of treatment and the date of evidence of systemic disease on bone scan or cross sectional imaging or death, whichever occurs first.|2 and 3 years|This rate is not estimable as 0 patients had locally recurrent disease before being taken off study for biochemical progression.|||||
772970|NCT00734851|Secondary|Rate of Local Recurrence at 2 and 3 Years|Local recurrence is defined as men with locally recurrent disease confirmed pathologically within the radiation field, and is estimated at 2 and 3 years.|24 months and 36 months|||percentage of participants|||Number
772971|NCT00734851|Secondary|Proportion of Biochemical Progression (bPFS Proportion) at 2 and 3 Years.|Percentage of participants surviving 24 and 36 months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression. Progression will be defined as having experienced any of the following: a serum prostate specific antigen (PSA) value of 0.2 ng/mL or more above the post-radiotherapy PSA nadir and confirmed 4 weeks later by a second PSA measurement that was higher than the first by any amount or a continued rise in the PSA level following study treatment if no nadir is experienced, defined as 2 rising values greater than the baseline PSA and separated by at least 4 weeks. Please note: bPFS is identical to PFS but includes only PSA-based endpoints or death.|24 months and 36 months|||percentage of patients||95% Confidence Interval|Number
772972|NCT00734851|Primary|The Rate of Progression Free Survival (PFS) at 24 Months|Percentage of participants surviving 24 months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression. Progression will be defined as having experienced any of the following: a serum prostate specific antigen (PSA) value of 0.2 ng/mL or more above the post-radiotherapy PSA nadir and confirmed 4 weeks later by a second PSA measurement that was higher than the first by any amount, a continued rise in the PSA level following study treatment if no nadir is experienced, defined as 2 rising values greater than the baseline PSA and separated by at least 4 weeks, or evidence of clinical progression or initiation of systemic therapy for progressive disease.|2 years|||percentage of patients||95% Confidence Interval|Number
772973|NCT00734929|Secondary|"Number of Participants Who Rated Their Satisfaction With Antiemetic Management as Very Satisfied"|Participants rated their satisfaction with antiemetic management on a 5 points scale: very satisfied, somewhat satisfied, neither satisfied nor dissatisfied, somewhat dissatisfied, very dissatisfied)|48 hour|||participants|||Number
772974|NCT00734929|Secondary|Time to First Vomiting||48 h|The analysis population only includes participants who had vomiting and had a complete data set||hours||Inter-Quartile Range|Median
772975|NCT00734929|Secondary|Number of Vomiting Episodes||48 hours|||vomiting episodes||Inter-Quartile Range|Mean
772976|NCT00734929|Secondary|Average Nausea Score|Participants verbally rated their nausea on a scale of 0-10. 0 = No nausea, 10 = worst nausea imaginable|Post OP hours 0-2, 24 h, 48 h|||units on a scale||Inter-Quartile Range|Mean
772977|NCT00734929|Secondary|Number of Participants With a Complete Response Rate|complete response rate: defined as no Postoperative nausea and vomiting (PONV) and no need for rescue antiemetics.|24 hours Post OP, 48 hours Post OP|||participants|||Number
772978|NCT00734929|Secondary|Use of Rescue Antiemetics (48 Hours)||48 hour|||participants|||Number
772979|NCT00734929|Secondary|Use of Rescue Antiemetics (24 Hours)||24 h|||participants|||Number
772980|NCT00734929|Secondary|Use of Rescue Antiemetics (Post OP)||Post OP (0 - 2 hours)|||participants|||Number
772981|NCT00734929|Secondary|Incidence of Vomiting (24 Hours)|Any vomiting or retching|24 h|ITT analysis||participants|||Number
772990|NCT00735007|Secondary|The Incidence of Predefined Injection Site Reactions, MSTCQ Scores, Side Effects, McGill Pain Questionnaire, Visual Analog Scale, and Rating of Pain Regarding Injection Pain Following RNF Administration With RebiSmart at 12-week Treatment Period.|Information on these outcomes is shown separately above, apart from information on the incidence of injection site related adverse events which is shown in the Adverse Events section|at the end of weeks 4, 8, and 12 of treatment||||||
772991|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Grade Item 38 at End Week 12|Intention to treat population. MSTCQ Pain Rating Grade item 38. Rated as No pain; Mild; Discomforting; Distressing; or Horrible Excruciating|at the end of week 12 of treatment|Intention to treat population||participants|||Number
772992|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Grade Item 38 at End Week 8|Intention to treat population. MSTCQ Pain Rating Grade item 38. Rated as No pain; Mild; Discomforting; Distressing; or Horrible Excruciating|at the end of week 8 of treatment|5 subjects with missing values||participants|||Number
772993|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Grade Item 38 at End Week 4|Intention to treat population. MSTCQ Pain Rating Grade item 38. Rated as No pain; Mild; Discomforting; Distressing; or Horrible Excruciating|at the end of week 4 of treatment|5 subjects with missing values||participants|||Number
772994|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Scale Item 37 at End Week 12|Intention to treat population. MSTCQ Pain Rating Scale item 37. Visual Analogue Scale 0mm (No pain) to 100mm (Worst possible pain)|at the end of week 12 of treatment|Intention to treat population||mm (on a scale)||Standard Deviation|Mean
772995|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Scale Item 37 at End Week 8|Intention to treat population. MSTCQ Pain Rating Scale item 37. Visual Analogue Scale 0mm (No pain) to 100mm (Worst possible pain)|at the end of week 8 of treatment|5 subjects with missing values||mm (on a scale)||Standard Deviation|Mean
772996|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Scale Item 37 at End Week 4|Intention to treat population. MSTCQ Pain Rating Scale item 37. Visual Analogue Scale 0mm (No pain) to 100mm (Worst possible pain)|at the end of week 4 of treatment|4 subjects with missing values||mm (on a scale)||Standard Deviation|Mean
772997|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Benefit Item 35 at End Week 12|Intention to treat population. MSTCQ Injection Issues Score item 35 - Most important benefit of the RebiSmart injection system: Fewer injection site reactions; less injection pain; fewer flu-like symptoms; fewer physical side effects; or overall convenience.|at the end of week 12 of treatment|21 subjects with missing values||participants|||Number
772998|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Benefit Item 35 at End Week 8|Intention to treat population. MSTCQ Injection Issues Score item 35 - Most important benefit of the RebiSmart injection system: Fewer injection site reactions; less injection pain; fewer flu-like symptoms; fewer physical side effects; or overall convenience.|at the end of week 8 of treatment|21 subjects with missing values||participants|||Number
772999|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Benefit Item 35 at End Week 4|Intention to treat population. MSTCQ Injection Issues Score item 35 - Most important benefit of the RebiSmart injection system: Fewer injection site reactions; less injection pain; fewer flu-like symptoms; fewer physical side effects; or overall convenience.|at the end of week 4 of treatment|21 subjects with missing values||participants|||Number
773000|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Issues Score Item 34 at End Week 12|Intention to treat population. MSTCQ Injection Issues Score item 34: +5 is the best possible score (much better), -5 is the worst possible score (much worse), zero is neutral (no change)|at the end of week 12 of treatment|Intention to treat population||MSTCQ Score (units on a scale)||Standard Deviation|Mean
773001|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Issues Score Item 34 at End Week 8|Intention to treat population. MSTCQ Injection Issues Score item 34: +5 is the best possible score (much better), -5 is the worst possible score (much worse), zero is neutral (no change)|at the end of week 8 of treatment|5 subjects with missing values||MSTCQ Score (units on a scale)||Standard Deviation|Mean
773002|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Issues Score Item 34 at End Week 4|Intention to treat population. MSTCQ Injection Issues Score item 34: +5 is the best possible score (much better), -5 is the worst possible score (much worse), zero is neutral (no change)|at the end of week 4 of treatment|3 subjects with missing values||MSTCQ Score (units on a scale)||Standard Deviation|Mean
773003|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Global Side Effects Score Items 21-23 at End Week 12|Intention to treat population. MSTCQ Global Side Effects Score items 21-23 has a best possible score of 15 and a worst possible score of 3.|at the end of week 12 of treatment|Intention to treat population||MSTCQ Score (units on a scale)||Standard Deviation|Mean
773004|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Global Side Effects Score Items 21-23 at End Week 8|Intention to treat population. MSTCQ Global Side Effects Score items 21-23 has a best possible score of 15 and a worst possible score of 3.|at the end of week 8 of treatment|6 subjects with missing values||MSTCQ Score (units on a scale)||Standard Deviation|Mean
773005|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Global Side Effects Score Items 21-23 at End Week 4|Intention to treat population. MSTCQ Global Side Effects Score items 21-23 has a best possible score of 15 and a worst possible score of 3.|at the end of week 4 of treatment|3 subjects with missing values||MSTCQ Score (units on a scale)||Standard Deviation|Mean
773006|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Site Reaction Score Items 17-20 at End Week 12|Intention to treat population. MSTCQ InjectionSite Reaction Score items 17-20 has a best possible score of 4 and a worst possible score of 20.|at the end of week 12 of treatment|Intention to treat population||MSTCQ Score (units on a scale)||Standard Deviation|Mean
773007|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Site Reaction Score Items 17-20 at End Week 8|Intention to treat population. MSTCQ InjectionSite Reaction Score items 17-20 has a best possible score of 4 and a worst possible score of 20.|at the end of week 8 of treatment|6 subjects with missing values||MSTCQ Score (units on a scale)||Standard Deviation|Mean
773008|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Site Reaction Score Items 17-20 at End Week 4|Intention to treat population. MSTCQ InjectionSite Reaction Score items 17-20 has a best possible score of 4 and a worst possible score of 20.|at the end of week 4 of treatment|3 subjects with missing values||MSTCQ Score (units on a scale)||Standard Deviation|Mean
773009|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Flu Like Symptom (FLS) Score Items 13-16 at End Week 12|Intention to treat population. MSTCQ FLS Score items 13-16 has a best possible score of 4 and a worst possible score of 20.|at the end of week 12 of treatment|Intention to treat population||MSTCQ Score (units on a scale)||Standard Deviation|Mean
773010|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Flu Like Symptom (FLS) Score Items 13-16 at End Week 8|Intention to treat population. MSTCQ FLS Score items 13-16 has a best possible score of 4 and a worst possible score of 20.|at the end of week 8 of treatment|6 subjects with missing values||MSTCQ Score (units on a scale)||Standard Deviation|Mean
773011|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Flu Like Symptom (FLS) Score Items 13-16 at End Week 4|Intention to treat population. MSTCQ FLS Score items 13-16 has a best possible score of 4 and a worst possible score of 20.|at the end of week 4 of treatment|3 subjects with missing values||MSTCQ Score (units on a scale)||Standard Deviation|Mean
773012|NCT00735007|Primary|The Number of Subjects Rating the Suitability of RebiSmart at the End of 12-week Treatment Period for Self-injecting Rebif® New Formulation (RNF).|"RebiSmart was evaluated as very suitable or suitable; a little suitable; or not suitable at all for self-injecting RNF. The Patient User Trial Questionnaire (UTQ) provides confidence in the ability to evaluate the suitability of the device and ease of understanding the different features of the RebiSmart during the training session and the overall subject impression of the injection administration. Subjects completed the Patient UTQ at Study Day1, Week4, and Week12. The Trainer User UTQ provides confidence in the ability to evaluate the suitability of the RebiSmart by the trainer."|End of 12 week treatment period|4 subjects with missing values||participants|||Number
773013|NCT00735072|Primary|Week 24 Change in Percentage of CD8+ T Cells That Co-express CD38 and HLA DR (Week 24 %CD38+HLA-DR+ CD8+ T Cells Minus Baseline %CD38+HLA-DR+ CD8+ T Cells)||Week 24|||%CD38+ HLA-DR+ CD8+ T cells||Inter-Quartile Range|Median
773014|NCT00735072|Secondary|Change in Gut-associated Lymphoid Tissue HIV RNA Level (UCSF Site Only)||Week 24||||||
773015|NCT00735072|Secondary|Change in Brachial Artery Flow-mediated Dilatation (UCSF Site Only)||Week 24||||||
773016|NCT00735072|Secondary|Change in Ultra-sensitive Plasma HIV RNA Level (Single Copy/ml Assay)||Week 24||||||
773017|NCT00735072|Secondary|Change in CD4+ T Cell Count||Week 24||||||
773018|NCT00735306|Secondary|One Year Overall Survival From Time of Diagnosis|One year survival from time of diagnosis for patients who completed this regimen|1 year|||participants|||Number
773019|NCT00735306|Secondary|Number of Dose Limiting Toxicities||Within 30 days of completing radiation|||Events|||Number
773020|NCT00735306|Primary|Tarceva Maximum Tolerated Dose in mg|Tarceva maximum tolerated dose in mg|1 yr|||mg|||Number
773021|NCT00735371|Secondary|Youth Quality of Life-Research Version (YQOL-R) Total Score|The Youth Quality of Life-research version (YQOL-R) is a validated 56-item generic instrument for comparing quality of life of adolescents across condition groups that scores each question on a scale from 0 (never) to 4 (very often). The YQOL scores are transformed to a 0-100 scale for easy interpretability. Higher scores indicate better quality of life.|Baseline and 4 weeks|FAS||Units on a scale||Standard Deviation|Mean
773022|NCT00735371|Secondary|Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|1, 2, 3 and 4 Weeks|FAS||Participants|||Number
773023|NCT00735371|Primary|Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at up to 4 Weeks|The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|Baseline and 1, 2, 3 and 4 weeks|Full Analysis Set (FAS) is defined as all subjects who took at least one dose of study medication and had a valid Baseline and at least one post-Baseline follow-up assessment of the primary outcome measure (ADHD-RS-IV Total Score)||Units on a scale||Standard Error|Least Squares Mean
773024|NCT00735397|Secondary|Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline.|Seizure frequency was derived from information (seizure count and type) recorded in participant diary. The percentage of participants who experienced a 50% or greater reduction in seizure frequency per 28 days relative to the pre-perampanel Baseline(responders) was assessed. The pre-perampanel baseline was defined as: (1) for participants who had been assigned to placebo treatment in the core DB study, the Pre-perampanel baseline was computed from all data during the core Double-Blind (DB) study, and (2) for participants who had been assigned to perampanel in the core DB study, the pre-perampanel baseline was computed from the pre-randomization phase of the core DB study. The data is presented as percent responders.|Pre-perampanel Baseline and Weeks (1-13, 14-26, 27-39, 40-52, 53-65, 66-78, 79-91, 92-104, 105-117, 118-130, 131-143, 144-156, 157-169, 170-182, 183-195, 196-208, 209-221, 222-234, 235-247, 248-260)|Full Intent-to-treat population (ITT), defined as participants who provided informed consent for the OLE, received at least 1 dose of perampanel in the OLE, and had valid seizure data for overall, Complex Partial Plus Secondarily Generalized Seizures and Secondarily Generalized Seizures arm, respectively during the perampanel treatment duration.||Percent responders|||Number
773038|NCT00735462|Secondary|Number of Subjects With Any Treatment Related Adverse Reactions (AEs), Any Local Skin Reactions (LSRs), and Number of Subjects Who Took Rest Periods During the Treatment Period|"Treatment related defined as probably related or related by investigator. Local skin reactions (LSRs)were part of the treatment related adverse events and assessed by the investigators.
Rest periods defined as temporary interruption of dosing due to intolerable local skin reaction."|Up to 16 weeks|Analysis population was based on safety population which defined as for all subjects randomized and received at lease one dose. There was one subject who randomized to the 2.5% group but received one treatment kit of 3.75% imiq cream, so this subject was assigned to 3.75% for the safety analysis.||participants|||Number
773025|NCT00735397|Secondary|Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline.|Seizure frequency was derived from information (seizure count and type) recorded in participant diary. The seizure frequency per 28 days was calculated as the number of seizures divided by the number of days in the interval and multiplied by 28. The percent change in 28-day seizure frequency from pre-perampanel baseline was assessed for all partial-onset seizure types. The pre-perampanel baseline was defined as: (1) for participants who had been assigned to placebo treatment in the core DB study, the pre-perampanel baseline was computed from all data during the core DB study, and (2) for participants who had been assigned to perampanel in the core DB study, the pre-perampanel baseline was computed from the pre-randomization phase of the core DB study.|Pre-perampanel Baseline and Weeks (1-13, 14-26, 27-39, 40-52, 53-65, 66-78, 79-91, 92-104, 105-117, 118-130, 131-143, 144-156, 157-169, 170-182, 183-195, 196-208, 209-221, 222-234, 235-247, and 248-260)|Full Intent-to-treat population (ITT), defined as participants who provided informed consent for the OLE, received at least 1 dose of perampanel in the OLE, and had valid seizure data for overall, Complex Partial Plus Secondarily Generalized Seizures and Secondarily Generalized Seizures arm, respectively during the perampanel treatment duration.||Percent change||Full Range|Median
773026|NCT00735397|Primary|Number of Participants With Treatment-emergent Non-Serious Adverse Events (AEs) and Treatment-emergent Serious Adverse Events (SAEs)|An AE was defined as any untoward medical occurrence in a clinical investigation participant administered with an investigational product. A SAE was defined as any untoward medical occurrence that at any dose; resulted in death, was life-threatening (ie, the participant was at immediate risk of death from the AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was as a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). In this study, treatment emergent AEs (defined as an AE (serious or non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.|From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years.|The safety analysis set (SAS) was defined as participants who provided informed consent for the OLE study, received at least 1 dose of perampanel in the OLE study, and had at least 1 postdose safety assessment in the OLE study.||participants|||Number
773027|NCT00735436|Secondary|Incidence of Grade ≥ 4 Hematologic and ≥ Grade 3 Non-hematologic Toxicities|Incidence of grade ≥ 4 hematologic and ≥ grade 3 non-hematologic toxicities|47 months|intent-to-treat||participants|||Number
773028|NCT00735436|Secondary|Incidence and Severity of Central Nervous System (CNS) Hemorrhage|Incidence and severity of CNS hemorrhage|47 months|intent-to-treat||participants|||Number
773029|NCT00735436|Secondary|Median Overall Survival (OS)|Time in months from the start of study treatment to date of death due to any cause. Patients alive at last follow-up are censored as of that follow-up date. Median OS was estimated using a Kaplan-Meier curve.|Time in months from the start of study treatment to date of death due to any cause, assessed up to 47 months|intent-to-treat||months||95% Confidence Interval|Median
773030|NCT00735436|Secondary|Median Progression-free Survival (PFS)|Time in months from the start of study treatment to the date of first progression according to modified Macdonald criteria, or to death due to any cause. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve.|Time in months from the start of study treatment to the date of first progression according to modified Macdonald criteria or to death due to any cause, assessed up to 47 months|intent-to-treat||months||95% Confidence Interval|Median
773031|NCT00735436|Secondary|24-week Progression-free Survival (PFS)|The percentage of participants surviving 24 weeks from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to modified Macdonald criteria, or to death due to any cause.|24 weeks|intent-to-treat||percentage of participants||95% Confidence Interval|Number
773032|NCT00735436|Primary|24-week Overall Survival|The percentage of participants surviving 24 weeks from the start of study treatment|24 weeks|intent-to-treat||percentage of participants||95% Confidence Interval|Number
773033|NCT00735449|Secondary|Number of Subjects With Adverse Events|Number of subjects with adverse events, defined as any untoward medical occurrence in a subject, during the study (reported through the week 12 visit).|Week 12|Safety population, which included all patients who started the study (randomized) and were treated.||Participants|||Number
773034|NCT00735449|Secondary|Mean Intraocular Pressure (IOP) at 8 AM at Week 6|Mean IOP at 8 AM at week 6. IOP is a measurement of the fluid pressure inside the eye.|Week 6|Per-protocol, which included all patients who started the study (randomized) and had at least one follow-up visit.||Millimeters of mercury (mmHg)||Standard Deviation|Mean
773035|NCT00735449|Secondary|Mean Intraocular Pressure (IOP) at 8 AM at Week 12|Mean IOP at 8 AM at week 12. IOP is a measurement of the fluid pressure inside the eye.|Week 12|Per-protocol, which included all patients who started the study (randomized) and had at least one follow-up visit and who were assessed for this outcome measure at the Week 12 visit.||Millimeters of mercury (mmHg)||Standard Deviation|Mean
773036|NCT00735449|Primary|Mean Intraocular Pressure (IOP) at 10 AM at Week 12|Mean IOP at 10 AM at week 12. IOP is a measurement of the fluid pressure in the eye.|Week 12|Per-protocol, which included all patients who started the study (randomized) and had at least one follow-up visit and who were assessed for this outcome measure at the Week 12 visit.||Millimeters of mercury (mmHg)||Standard Deviation|Mean
773037|NCT00735449|Secondary|Mean Intraocular Pressure (IOP) at 10 AM at Week 6|Mean IOP at 10 AM at week 6. IOP is a measurement of the fluid pressure inside the eye.|Week 6|Per-protocol, which included all patients who started the study (randomized) and had at least one follow-up visit.||Millimeters of mercury (mmHg)||Standard Deviation|Mean
773039|NCT00735462|Primary|Proportion of Subjects Achieving Complete Clearance of All Warts (Baseline and New) at the End of Study.|The complete clearance was defined as completely cleared all warts including baseline and newly emerged during the study at all anatomic areas.|Up to 16 weeks|||proportion of participants||95% Confidence Interval|Number
773264|NCT00730353|Secondary|Overall Survival|To determine the one year overall survival rate for the combination of sunitinib malate and paclitaxel in advanced esophageal carcinoma|12 months|All participants on an intent-to-treat basis||percentage of participants||90% Confidence Interval|Median
773040|NCT00735475|Secondary|New Onsets of Chronic Illness|A NOCI was defined as the diagnosis of a chronic medical condition where the symptoms commenced or worsened following exposure to the study vaccine and may have included those potentially controllable by medication (e.g., glaucoma, hypertension).|180 days after vaccination|Safety Population: comprised all participants who received study vaccine and provided safety follow-up safety data.||participants|||Number
773041|NCT00735475|Secondary|Serious Adverse Events||180 days after vaccination|Safety Population: comprised all participants who received study vaccine and provided safety follow-up safety data.||participants|||Number
773042|NCT00735475|Secondary|Frequency and Intensity of Unsolicited Adverse Events (UAEs)|Abbreviation UAE stands for Unsolicited Adverse Event.|21 days after vaccination|||participants|||Number
773043|NCT00735475|Secondary|Duration of Local and Systemic Solicited Symptoms||5 days after vaccination|||Days||Standard Deviation|Mean
773044|NCT00735475|Secondary|Frequency and Intensity of Local and Systemic Solicited Symptoms||5 days after vaccination|Safety Population: comprised all participants who received study vaccine and provided safety follow-up safety data.||Percentage of Participants|||Number
773045|NCT00735475|Primary|Percentage of Participants With Seroconversion 21 Days After the Study Vaccination|Seroconversion rate was defined as the proportion of participants with a HI titer of less than 1:10 before vaccination achieving a HI antibody titer of 1:40 or more after vaccination, or with a HI titer of 1:10 or more before vaccination achieving a four-fold or greater increase in HI titer after vaccination.|21 days after vaccination|Evaluable Population: comprised participants who were vaccinated, provided blood samples before and after vaccination, did not experience a laboratory-confirmed influenza infection, and did not receive a contraindicated medication.||Percentage of participants||95% Confidence Interval|Number
773046|NCT00735475|Primary|Geometric Mean Titer 21 Days After the Study Vaccination||21 days after vaccination|Evaluable Population: comprised participants who were vaccinated, provided blood samples before and after vaccination, did not experience a laboratory-confirmed influenza infection, and did not receive a contraindicated medication.||Titers||95% Confidence Interval|Geometric Mean
773047|NCT00735553|Primary|To Determine the Efficacy of 50 mg Proellex® Versus Placebo in the Treatment of Subjects With Symptomatic Uterine Fibroids From Baseline to Month 4 as Determined by Scoring Changes in the Pictorial Blood Loss Assessment Chart (PBAC)||4 months|Study prematurely terminated|||||
773048|NCT00735618|Primary|Differences Between Pre/Post ESAS Score|Total symptom burden as measured by Edmonton Symptom Assessment Scale (ESAS) in which there are eight visual analog scales (VAS) of 0 to 10, with 10 being most severe. The differences from ESAS baseline (before) to post (after) a 15 minute, one-time, guided relaxation program for each participant assessed, with the average difference in ESAS scores for all participants reported.|Baseline and following completion of HRV recordings and relaxation program (45 - 60 minutes elapsed time)|Analysis included all study participants.||units on a scale||Standard Deviation|Mean
773049|NCT00735644|Other Pre-specified|Serological Status of Flavivirus Infection at Baseline (Before) Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Hepatitis A Vaccine.|Flavivirus (FV) positive was defined as anti-JE against homologous virus strain ≥10 l/dil or anti dengue against at least one serotype ≥10 l/dil. FV negative was defined as anti-JE against homologous virus strain <10 l/dil and anti-dengue against the 4 serotypes <10 l/dilution.|Day 0 (pre-vaccination)|Serological status of Flavivirus infection was assessed in the Per-protocol Analysis Set.||Participants|||Number
773050|NCT00735644|Secondary|Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine.|Solicited injection site: Tenderness, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, and Irritability. Grade 3 injection site: Tenderness, cries when injected limb is moved or the movement of injected limb is reduced; Erythema and Swelling ≥5 cm. Grade 3 systemic reactions: Fever, temperature >39.5˚C; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying Abnormal, >3 hours; Drowsiness, sleeping most of the time or difficult to wake up; Appetite Lost, refuses ≥3 or most feeds/meals; and Irritability, inconsolable.|Day 0 up to Day 14 post-vaccination|Solicited injection site and systemic reactions were assessed in the Safety Analysis Set. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.||Participants|||Number
773051|NCT00735644|Secondary|Geometric Mean Titers Ratios Against the Japanese Encephalitis Chimeric Virus (JE-CV) Antigen Following Vaccination With One of the JE-CV by GPO MBP Lots or WRAIR JE-CV Vaccine|Anti Japanese encephalitis chimeric virus antibodies were measured using the PRNT50 assay.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Geometric mean titers against the JE CV antigens were assessed in the Per Protocol Analysis Set.||Titer ratio||95% Confidence Interval|Geometric Mean
773052|NCT00735644|Secondary|Number of Participants With Seroprotection to Japanese Encephalitis Chimeric Virus Antigens Before and Following Vaccination With a JE-CV by GPO MBP Lot or WRAIR JE-CV|Anti-Japanese encephalitis chimeric virus vaccine antibodies were measured using the PRNT50 assay. Seroprotection was defined as the proportion of subjects with a JE CV virus PRNT50 neutralizing antibody titer ≥10 1/dilution (dil).|Day 0 (pre-vaccination) and Day 28 post-vaccination|Seroprotection against JE CV antigens was assessed in the participants who were vaccinated and completed all study defined activities, Per-Protocol Analysis Set.||Participants|||Number
773053|NCT00735644|Secondary|Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) Antigens Before and Following Vaccination With a JE-CV by GPO MBP Lot or Walter Reed Army Institute of Research (WRAIR) JE-CV|Anti-Japanese Encephalitis Chimeric Virus antibodies were measured using the 50% plaque reduction neutralization test (PRNT50) assay.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Geometric mean titers against the JE CV antigens were assessed in the participants who were vaccinated and completed all study defined activities, Per-Protocol Analysis Set.||Titers||95% Confidence Interval|Geometric Mean
773103|NCT00735787|Secondary|Number of Subjects With PGA of Clear or Almost Clear|Number of subjects achieving a PGA of clear (representing no signs of plaque psoriasis) or almost clear (representing just perceptible erythema and scaling). The PGA is a 5-point scale used to measure the severity of disease at the time of the physician's evaluation of the subject. The degree of overall severity is rated as follows: 0-Clear, 1-Almost clear, 2-Mild, 3-Moderate, and 4-Severe.|Baseline and Weeks 2, 4, 8, 12, 20, 24, and 28|Analysis was based on the ITT subject population and performed using non-responder imputation (NRI).||subjects|||Number
773054|NCT00735644|Primary|Number of Participants With Seroconversion to Vaccine Antigens Following Vaccination With JE-CV by GPO MBP Lots|Anti-Japanese encephalitis chimeric virus vaccine antibodies were measured using the 50% plaque reduction neutralization test (PRNT50). Seroconversion was defined as participants with a pre-vaccination titer <10 1/dil and post-vaccination titer ≥ 10 1/dil, or participants with pre-vaccination titer ≥ 10 1/dil and 4-fold increase from pre- to post-vaccination.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Seroconversion to the JE CV vaccine antigens was assessed in the participants who were vaccinated and completed all study defined activities, Per-Protocol Analysis Set.||Participants|||Number
773055|NCT00735670|Secondary|Depression Scale of the Patient Health Questionnaire (PHQ-9)|The nine items of the PHQ-9 are based directly on the nine diagnostic criteria for major depressive disorder in the DSM-IV. Higher total scores indicate more severe symptomatology, ranging from 0 (no symptoms) to 27 (most severe symptoms). Data in the tables begin with the overall mean for each group that includes all subjects, average across all assessment time points. Each subsequent row reports the mean and standard deviation of each time point by allocation, noting sample size for each group in the arm/group title given missing data in each time point after baseline.|Baseline and weeks 1, 2, 3, 5, 9, 13, 14, 15, 16, 18, 20 and 26 weeks|Subjects with PHQ-9 data at any of the measurement time points (baseline, weeks 1, 2, 3, 5, 9, 13, 14, 15, 16, 18, 20 and 26 weeks) are included in the means reported for each time point. The sample size for each time point is given in the category title (e.g., 10Ven = 10 venlafaxine group or 11Plac = 11 placebo group) if it deviates from baseline.||units on a scale||Standard Deviation|Mean
773056|NCT00735670|Primary|16-Item Quick Inventory of Depressive Symptomatology – Self Report (QIDS-SR16)|The QIDS assesses symptoms of depression across the nine DSM-IV criterion domains for major depressive episode. The primary end-point in this study was the number of participants who had a >50% change in scores on the QIDs from baseline to week 13 (end of treatment period).|Baseline and Week 13|Participants who completed the week 13 assessment.||participants|||Number
773057|NCT00735696|Secondary|Maximum Concentration of Ramucirumab (Cmax)||Week 18 (Cycle 6), at 1-Hour Post End of Infusion|Participants who received any quantity of study medication and had evaluable concentration data at the specified time point.||micrograms/milliliter (mcg/mL)||Standard Deviation|Mean
773058|NCT00735696|Secondary|Serum Anti-Ramucirumab Antibody Assessment|The number of participants who developed treatment emergent antibody responses to ramucirumab after baseline.|Week 15 (Cycle 5)|Participants who had Anti-Ramucirumab Antibody assessment at week 15 (cycle 5).||participants|||Number
773059|NCT00735696|Secondary|Overall Survival (OS)|Overall survival is defined as the time from the first dose of study medication to the date of death from any cause. Participants who were alive at the end of the follow-up period or lost to follow-up were censored on the last date the patient was known to be alive.|First dose to death due to any cause, up to 32.5 months|"Modified intent to treat population (mITT): All participants who received any quantity of study drug.
Fourteen participants were censored."||months||95% Confidence Interval|Median
773060|NCT00735696|Secondary|Progression-free Survival (PFS)|"Defined as the time from date of first dose of study medication to the first documented disease progression as defined by Response Evaluation Criteria In Solid Tumors (RECIST 1.0), initiation of additional antitumor therapy was first reported or death due to any cause.
Participants who did not progress, who discontinued treatment for toxicity or a reason other than documented progression, or who were lost to follow-up before documented progression or death were censored at date of last tumor assessment. Participants who started new therapeutic anticancer treatment prior to documented progression or death were censored at date of last tumor assessment prior to new therapeutic anticancer therapy."|First dose to measured progressive disease or death due to any cause, up to 32.5 months|"Modified intent to treat population (mITT): All participants who received any quantity of study drug.
Nine participants were censored."||months||95% Confidence Interval|Median
773061|NCT00735696|Secondary|Overall Survival (OS) at 1 Year|Data presented are the percentage of participants surviving at least 12 months after first dose of study medication.|First dose to 1 year|Modified intent to treat population (mITT): All participants who received any quantity of study drug.||percentage of participants||95% Confidence Interval|Number
773062|NCT00735696|Secondary|Duration of Response|The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression, initiation of additional antitumor therapy is first reported, or death as a result of any cause. CR was defined as the disappearance of all target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions.|First dose up to 32.5 months|Participants who had tumor response. Two participants who had tumor response did not progress by the data cut-off date, therefore were censored for duration of response analysis.||months||95% Confidence Interval|Median
773063|NCT00735696|Secondary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate ([ORR])|Objective response is Complete Response (CR) + Partial Response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST 1.0) guidelines. CR is a disappearance of all target and non-target lesions; PR is at least a 30% decrease in the sum of the longest diameter of target lesions without new lesions and progression of non-target lesions. Objective response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with measurable disease, multiplied by 100.|First dose to measured progressive disease or death due to any cause up to 32.5 months|Modified intent to treat population (mITT): All participants who received any quantity of study drug.||percentage of participants||95% Confidence Interval|Number
773064|NCT00735696|Secondary|Summary of Participants Reporting Adverse Events|Data presented are the number of participants who experienced ramucirumab related treatment-emergent adverse events (TEAE), treatment related serious adverse events (SAE), or any Grade 3 or higher TEAE; any TEAE leading to discontinuation of ramucirumab treatment, and any TEAE leading to dose modification ramucirumab. A summary of SAEs and other nonserious AEs, regardless of causality, is located in the Reported Adverse Event section.|Baseline up to 32.5 months|Safety Population: All participants who received any quantity of study drug.||participants|||Number
773138|NCT00736034|Secondary|Clinical Global Impression of Change (CGI-C)Scale|The Clinical Global Impression of Change (CGI-C)scale is designed to record the clinician’s global impression of change. Global improvement score ranges from 1 = “Very much improved”, through 4 = “No change”, to 7 = “Very much worse”. Participants who experienced an improvement (scores 1, 2 or 3) were classified as improved over the treatment period.|15 weeks||||||
773065|NCT00735696|Primary|Percentage of Participants Who Are Progression-free (PFS) at 6 Months|Data presented are the percentage of participants without disease progression or death at 6 months. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Progressive disease was defined as having at least a 20% increase in sum of longest diameter of target lesions or the appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions.|6 months|"Modified intent to treat population (mITT): All participants who received any quantity of study drug.
Nine participants were censored."||percentage of participants||95% Confidence Interval|Number
773066|NCT00735709|Secondary|Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire.|Healthcare resource utilization was assessed by the Health Economic Assessment (HEA) questionnaire, which monitors the participants' absenteeism from work, as well as resource use such as visits to a general practitioner, outpatient and inpatient services, hospitalization, medications, and other relevant services over the past 8 weeks.|Baseline and Week 8|Full analysis set||participants|||Number
773067|NCT00735709|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Mental Health Subscore at All Weeks Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The mental health sub-score assesses general mental health (psychological distress and well-being) and ranges from 0 (best) - 100 (worst). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 2, 4 and 8|"Full analysis set with available SF-36 Subscore data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
773068|NCT00735709|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Emotional Subscore at All Weeks Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The role-emotional subscale assesses limitations in usual role activities because of emotional problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 2, 4 and 8|"Full analysis set with available SF-36 Subscore data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
773069|NCT00735709|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Other Weeks Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The social functioning subscale assesses limitations in social activities because of physical or emotional problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 2 and 4|"Full analysis set with available SF-36 Subscore data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
773070|NCT00735709|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Vitality Subscore at All Weeks Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The vitality sub-score assesses energy and fatigue, and ranges from 0 (best) - 100 (worst). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 2, 4 and 8|"Full analysis set with available SF-36 Subscore data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
773071|NCT00735709|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Subscore at All Weeks Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The general health sub-score scale ranges from 0 (best) - 100 (worst). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 2, 4 and 8|"Full analysis set with available SF-36 Subscore data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
773072|NCT00735709|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Bodily Pain Subscore at All Weeks Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The bodily pain sub-score scale ranges from 0 (best) - 100 (worst). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 2, 4 and 8|"Full analysis set with available SF-36 Subscore data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
773073|NCT00735709|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Physical Subscore at All Weeks Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The role-physical subscale assesses limitations in usual role activities because of physical health problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 2, 4 and 8|"Full analysis set with available SF-36 Subscore data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
773074|NCT00735709|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Physical Functioning Subscore at All Weeks Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The physical functioning subscale assesses limitations in physical activities because of health problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 2, 4 and 8|"Full analysis set with available SF-36 Subscore data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
773075|NCT00735709|Secondary|Change From Baseline in Hospital Anxiety and Depression (HAD) Scales at Each Week Assessed|The HAD scale is completed by the participant and comprises two subscales, one measuring depression (focusing on the state of lost interest and diminished pleasure response) and one measuring anxiety (including anxious mood, restlessness, anxious thoughts, panic attacks). Each subscale is made up of 7 items that are assessed on a scale of 0 = no anxiety/depression to 3 = severe feeling of anxiety/depression. Participants are required to indicate the response which most accurately reflects the way they have felt over the last few days. Scores for the depression and anxiety subscales are summed separately and not combined, with each score ranging from 0 to 21 (maximal severity). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis|Baseline and Weeks 1, 4, and 8|"Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
773076|NCT00735709|Secondary|Change From Baseline in Clinical Global Impression Scale-Severity of Illness at Each Week Assessed|The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the participant's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 1, 2, 4, 6, and 8|"Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
773077|NCT00735709|Secondary|Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Each Week Assessed|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56, where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 1, 2, 4, 6, and 8|"Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
773078|NCT00735709|Secondary|Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score at Each Week|The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 1, 2, 4, 6, and 8|"Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
773079|NCT00735709|Secondary|Percentage of Participants With a Sustained Response in HAM-D24 Total Score|A sustained response is defined as a ≥20% decrease from Baseline in HAM-D24 total score obtained at Week 1 and sustained through Week 7 and at least 50% decrease from Baseline at Week 8.|From Baseline through Week 8|Full analysis set||percentage of participants|||Number
773080|NCT00735709|Secondary|Percentage of Participants in MADRS Remission at Other Weeks Assessed|Remission is defined as a participant with a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≤10. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.|Weeks 1, 2, 4 and 6|Full analysis set with available data at Week 1; Last observation carried forward was used for other time points.||percentage of participants|||Number
773089|NCT00735709|Secondary|Clinical Global Impression Scale-Global Improvement at Week 8|The Clinical Global Impression - Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline to Week 8|Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.||scores on a scale||Standard Error|Least Squares Mean
773165|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Glucose|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 54 mg/dL.|78 weeks|Treated Set with values for Glucose||participants|||Number
773166|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Aspartate Transaminase (AST)|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.|78 weeks|Treated Set with values for AST||participants|||Number
773081|NCT00735709|Secondary|Change From Baseline in HAM-D24 Total Score at Other Weeks Assessed in Participants With a Baseline HAM-A Score ≥20|The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score range from 0 to 74 where a higher score indicates a greater depressive state. The Hamilton Anxiety Scale (HAM-A) is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (symptoms severe). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 1, 2, 4 and 6|"Full analysis set patients with a HAM-A Baseline score ≥20 and with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
773082|NCT00735709|Secondary|Percentage of Responders in HAM-D24 Total Score at Other Weeks Assessed|A responder is defined as a participant with a ≥50% decrease from Baseline in HAM-D24 total score. The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74, where a higher score indicates a greater depressive state.|Baseline and Weeks 1, 2, 4 and 6|"Full analysis set with available data at Week 1; Last observation carried forward (LOCF) was used for other time points. n indicates the number of patients included in the analysis at each time point."||percentage of participants|||Number
773083|NCT00735709|Secondary|Clinical Global Impression Scale-Global Improvement at Other Weeks Assessed|The Clinical Global Impression - global improvement assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 1, 2, 4 and 6|"Full analysis set with available CGI-S data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
773084|NCT00735709|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Other Weeks Assessed|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 1, 2 and 6|"Full analysis set with available SDS Total Score data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
773085|NCT00735709|Secondary|Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Other Weeks Assessed|The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score range is from 0 to 74 where a higher score indicates a greater depressive state. LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 1, 2, 4 and 6|"Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
773086|NCT00735709|Secondary|Percentage of Participants in MADRS Remission at Week 8|Remission is defined as a participant with a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≤10. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.|Week 8|Full analysis set; LOCF was used.||percentage of participants|||Number
773087|NCT00735709|Secondary|Change From Baseline in HAM-D24 Total Score at Week 8 in Participants With Baseline HAM-A Score ≥20|The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74 where a higher score indicates a greater depressive state. The Hamilton Anxiety Scale (HAM-A) is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (severe symptoms). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline to Week 8|Full analysis set patients with a HAM-A Baseline score ≥ 20. A mixed model for repeated measurements (MMRM) based on observed cases was used.||scores on a scale||Standard Error|Least Squares Mean
773088|NCT00735709|Secondary|Percentage of Responders in HAM-D24 Total Score at Week 8|A responder is defined as a participant with a ≥50% decrease from Baseline in HAM-D24 total score. The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74, where a higher score indicates a greater depressive state.|Baseline and Week 8|Full analysis set; last observation carried forward (LOCF) was used.||percentage of participants|||Number
773090|NCT00735709|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline to Week 8|Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.||scores on a scale||Standard Error|Least Squares Mean
773091|NCT00735709|Primary|Change From Baseline in the 24-item Hamilton Depression Scale Total Score At Week 8|The 24-item Hamilton Depression Scale (HAM-D24) is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score range is from 0 to 74 where a higher score indicates a greater depressive state. Least squares (LS) means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline to Week 8|The full analysis set (FAS) included all patients who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline value for assessment of primary efficacy. A mixed model for repeated measurements (MMRM) based on observed cases was used.||scores on a scale||Standard Error|Least Squares Mean
773092|NCT00735787|Secondary|Number of Subjects With Difficulties According to PHQ-9|Based on the 9 questions of the PHQ-9, if subjects indicated any problems (PHQ-9 score > 0), the difficulty to do work, take care of things at home, and get along with people (question 10 of the PHQ) were assessed (not difficult at all, somewhat difficult, very difficult, and extremely difficult).|Baseline and Weeks 2, 8, 16, and 28|"Analysis was based on the ITT subject population. Missing values were imputed as extremely difficult."||subjects|||Number
773093|NCT00735787|Secondary|Mean Change From Baseline in Patient Health Questionnaire (PHQ-9)|The PHQ-9 consists of 9 questions that assess how often over the past 2 weeks subjects had signs or symptoms of depression (0=not at all, 1=several days, 2=more than half days, and 3=nearly every day). The PHQ-9 is the sum of the scores from the 9 questions for a total range from 0 (not depressed at all) to 27 (depressed nearly every day).|Baseline and Weeks 2, 8, 16, and 28|Analysis was based on the ITT subject population and performed using LOCF.||units on a scale||Standard Deviation|Mean
773094|NCT00735787|Secondary|Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO)|WPAI:PSO assesses the effect on the subject's ability to work and perform regular activities in 4 areas: % work time (in hours) missed due to psoriasis, % impairment while working (on a scale from 0 [psoriasis having no effect] to 10 [psoriasis completely prevented subject from working]), % overall work impairment (on a scale from 0 [psoriasis having no effect] to 10 [psoriasis completely prevented subject from working]), and % activity impairment (on a scale from 0 [psoriasis having no effect on daily activities] to 10 [psoriasis completely prevented subject from doing daily activities]).|Baseline and Weeks 8, 16, and 28|Analysis was based on the ITT subject population and performed using LOCF.||units on a scale||Standard Deviation|Mean
773095|NCT00735787|Secondary|Mean Change From Baseline in Visual Analog Scale (VAS) for Psoriasis and Psoriatic Arthritis Pain|On one single VAS, subjects assessed their pain due to psoriasis (and psoriatic arthritis, if applicable). Mean change in psoriasis and psoriatic arthritis pain from Baseline as measured by a VAS from 0 (no pain) to 100 (pain as bad as it could be).|Baseline and Weeks 16 and 28|Analysis was based on the ITT subject population and performed using LOCF.||mm on scale||Standard Deviation|Mean
773096|NCT00735787|Secondary|Number of Subjects Achieving a DLQI of 0|Number of subjects achieving a DLQI score of 0, indicating total lack of impairment. The DLQI consists of 10 questions and is scored from 0 to 30 (life is very much impaired). A decrease in DLQI indicates improvement.|Baseline and Weeks 2, 8, 16, and 28|Analysis was based on the ITT subject population and performed using NRI.||subjects|||Number
773097|NCT00735787|Secondary|Mean Change From Baseline in Dermatology Life Quality Index (DLQI)|The DLQI consists of 10 questions and is scored from 0 (total lack of impairment) to 30 (life is very much impaired). A decrease in DLQI indicates improvement.|Baseline and Weeks 2, 8, 16, and 28|Analysis was based on the ITT subject population and performed using LOCF.||units on a scale||Standard Deviation|Mean
773098|NCT00735787|Secondary|Number of Subjects With PASI 100|Number of subjects who achieved 100% improvement from baseline PASI. The PASI scale is from 0 (no psoriasis) to 72 (complete erythroderma of the severest possible degree).|Baseline and Weeks 16 and 28|Analysis was based on the ITT subject population and performed using NRI.||subjects|||Number
773099|NCT00735787|Secondary|Number of Subjects With PASI 90|Number of subjects who achieved 90% or greater improvement from baseline PASI. The PASI scale is from 0 (no psoriasis) to 72 (complete erythroderma of the severest possible degree).|Baseline and Weeks 16 and 28|Analysis was based on the ITT subject population and performed using NRI.||subjects|||Number
773100|NCT00735787|Secondary|Number of Subjects With PASI 75|Number of subjects who achieved 75% or greater improvement from baseline PASI. The PASI scale is from 0 (no psoriasis) to 72 (complete erythroderma of the severest possible degree).|Baseline and Weeks 16 and 28|Analysis was based on the ITT subject population and performed using NRI.||subjects|||Number
773101|NCT00735787|Secondary|Number of Subjects With Psoriasis Area and Severity Index (PASI) 50|Number of subjects who achieved 50% or greater improvement from baseline PASI. The PASI scale is from 0 (no psoriasis) to 72 (complete erythroderma of the severest possible degree).|Baseline and Weeks 16 and 28|Analysis was based on the ITT subject population and performed using NRI.||subjects|||Number
773102|NCT00735787|Secondary|Number of Subjects With PGA of Clear|Number of subjects achieving a PGA of clear (representing no signs of plaque psoriasis). The PGA is a 5-point scale used to measure the severity of disease at the time of the physician's evaluation of the subject. The degree of overall severity is rated as follows: 0-Clear, 1-Almost clear, 2-Mild, 3-Moderate, and 4-Severe.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, and 28|Analysis was based on the ITT subject population and performed using NRI.||subjects|||Number
773167|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Alanine Transaminase (ALT)|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.|78 weeks|Treated Set with values for ALT||participants|||Number
773104|NCT00735787|Secondary|Number of Subjects With Physicians Global Assessment of Psoriasis (PGA) of Clear, Almost Clear, or Mild|Number of subjects achieving a PGA of clear (representing no signs of plaque psoriasis), almost clear (representing just perceptible erythema and scaling), or mild (representing light pink erythema with minimal scaling and with or without pustules). The PGA is a 5-point scale used to measure the severity of disease at the time of the physician's evaluation of the subject. The degree of overall severity is rated as follows: 0-Clear, 1-Almost clear, 2-Mild, 3-Moderate, and 4-Severe.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, and 28|Analysis was based on the ITT subject population and performed using non-responder imputation (NRI).||subjects|||Number
773105|NCT00735787|Secondary|Mean Change From Baseline in Nail Psoriasis Severity Index (NAPSI)|For subjects with psoriasis nail involvement at Baseline, the target fingernail (most severely involved fingernail at Baseline) was assessed for NAPSI throughout the study. NAPSI ranges from 0 (no nail psoriasis) to 8 (most severe nail psoriasis).|Baseline and Weeks 8, 16, and 28|Analysis was performed in the ITT subject population for subjects with nail involvement at baseline only and is based on LOCF.||units on a scale||Standard Deviation|Mean
773106|NCT00735787|Secondary|Number of Subjects With Marked Improvement in ESIF From Baseline|Number of subjects that achieved > 75% reduction from Baseline in ESIF|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28|Analysis was based on the ITT subject population and performed using non-responder imputation (NRI).||subjects|||Number
773107|NCT00735787|Secondary|Number of Subjects With Moderate Improvement in ESIF From Baseline|Number of subjects that achieved > 50% reduction from Baseline in ESIF.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28|Analysis was based on the ITT subject population and performed using non-responder imputation (NRI).||subjects|||Number
773108|NCT00735787|Secondary|Mean Change From Baseline in ESIF for Soles|Severity of each sign of ESIF was assessed using a 4-point scale (0 = clear, 1 = mild, 2 = moderate, and 3 = severe). The ESIF was calculated by adding the scores for the 4 signs for the soles of the feet, yielding a total range from 0 (no disease) to 24 points (most severe condition) for the soles. A decrease from Baseline in ESIF indicates improvement.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28|Analysis was based on the ITT subject population and performed using the LOCF method.||units on a scale||Standard Deviation|Mean
773109|NCT00735787|Secondary|Mean Change From Baseline in ESIF for Palms|Severity of each sign of ESIF was assessed using a 4-point scale (0 = clear, 1 = mild, 2 = moderate, and 3 = severe). The ESIF was calculated by adding the scores for the 4 signs for the palms of the hands, yielding a total range from 0 (no disease) to 24 points (most severe condition) for the palms. A decrease from Baseline in ESIF indicates improvement.|Baseline and Weeks 2, 4, 12, 16, 20, 24, and 28|Analysis was based on the ITT subject population and performed using the LOCF method.||units on a scale||Standard Deviation|Mean
773110|NCT00735787|Secondary|Mean Change From Baseline in Erythema, Scaling, Induration, and Fissuring (ESIF)|Severity of each sign of ESIF was assessed using a 4-point scale (0 = clear, 1 = mild, 2 = moderate, and 3 = severe). The ESIF was calculated by adding the scores for the 4 signs for the two soles and two palms, for a total range from 0 (no disease) to 48 points (most severe condition). A decrease from Baseline in ESIF indicates improvement.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28|Analysis was based on the ITT subject population and performed using last observation carried forward (LOCF) method.||units on a scale||Standard Deviation|Mean
773111|NCT00735787|Primary|Number of Subjects With Physician's Global Assessment of Psoriasis (PGA) of Clear or Almost Clear at Week 16|Number of subjects achieving a PGA of clear (representing no signs of plaque psoriasis) or almost clear (representing just perceptible erythema and scaling) at Week 16. The PGA is a 5-point scale used to measure the severity of disease at the time of the physician's evaluation of the subject. The degree of overall severity is rated as follows: 0-Clear, 1-Almost clear, 2-Mild, 3-Moderate, and 4-Severe.|Week 16|Analysis was based on the intention to treat (ITT) subject population. Subjects who did not achieve PGA assessments at Week 16 were imputed as non-responders.||subjects|||Number
773112|NCT00735839|Primary|Number of Participants With Vaccine-related Serious Adverse Experiences|Vaccine-related adverse experiences are those determined by the investigator to be possibly, probably, or definitely vaccine-related.|Baseline (Day 1) to Day 84 postvaccination|||Participants|||Number
773113|NCT00735839|Primary|Geometric Mean Fold Rise (GMFR) From Baseline in Antibody Level|Geometric mean fold rise is calculated as the natural logarithm of the ratio of Day 14 and baseline antibody titers.|Baseline (Day 1) to Day 14 postvaccination|||Ratio||95% Confidence Interval|Geometric Mean
773114|NCT00735904|Secondary|Duration of Response (DR)|Time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Baseline until disease progression or discontinuation from the study due to any cause, assessed every 6 weeks during chemotherapy phase and every 8 weeks during single agent phase up to final study visit (Week 78)|DR was calculated for the subgroup of participants from the ITT set, with a confirmed objective tumor response (CR or PR).||Months||95% Confidence Interval|Median
773115|NCT00735904|Secondary|Progression Free Survival (PFS)|"Time in months from start of study treatment to the first documentation of objective tumor progression or to death due to any cause. PFS calculated as (Months) = (first event date minus first dose date plus 1) divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Baseline, assessed every 2 months (up to 28 days after the last dose)|ITT population included all enrolled participants who received at least 1 dose of study drug.||Months||95% Confidence Interval|Median
773116|NCT00735904|Secondary|Overall Survival (OS)|Time in months from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Baseline until death or assessed every 2 months (up to 28 days after the last dose)|ITT population included all enrolled participants who received at least 1 dose of study drug.||Months||95% Confidence Interval|Median
773265|NCT00730353|Secondary|Response Rate|To determine the response rate for the combination of sunitinib malate and paclitaxel in advanced esophageal carcinoma per RECIST criteria.|6 months|Evaluable patients, as previously defined.||percentage of participants||90% Confidence Interval|Number
773117|NCT00735904|Primary|Percentage of Participants With Objective Response (OR)|Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed response are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are those with disappearance of all target lesions. PR are those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions.|Baseline until disease progression or discontinuation from the study due to any cause, assessed every 6 weeks during chemotherapy phase and every 8 weeks during single agent phase up to final study visit (Week 78)|Intent-to-treat (ITT) population included all enrolled participants who received at least 1 dose of study drug.||Percentage of participants||95% Confidence Interval|Number
773118|NCT00735917|Secondary|Progression-Free Survival|Time from the date of registration to the date of progression or death, whichever occurs first. Estimated by the method of Kaplan-Meier.|Progression and survival status assessed every month, up to 2 years|||months||95% Confidence Interval|Median
773119|NCT00735917|Secondary|Duration of Response|Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient’s objective status is first noted to be either a CR or PR to the date progression is documented. Estimated by the method of Kaplan-Meier.|From the date first objective status is noted to be either a CR or PR to the date progression is documented, assessed up to 2 years|No patients qualified for a confirmed response and therefore this endpoint was not analyzed.|||||
773120|NCT00735917|Secondary|Confirmed Tumor Responses (Complete Response [CR] or Partial Response [PR])|"A confirmed tumor response is defined to be a CR or PR noted as > the objective status on 2 consecutive evaluations at least 4 weeks apart. Response will be evaluated in this study using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) > > Complete Response (CR): Disappearance of all non-nodal target lesions and each target lymph node must have a reduction in short axis to <1.0 centimeters. >
> Partial response (PR): At least a 30% decrease in the sum of the longest diameters of the non-nodal target lesions and the short axes of the target lymph nodes taking as reference the baseline sum of diameters."|Evaluated using the first 6 courses of treatment|||participants|||Number
773121|NCT00735917|Secondary|Overall Survival|Overall survival time is defined as the time from registration to death due to any cause. The median survival time and 95% confidence intervals will be estimated using the method of Kaplan-Meier.|Up to 2 years|||months||95% Confidence Interval|Median
773122|NCT00735917|Primary|Six Month Survival|The proportion of successes will be estimated by the number of surviving participants at 6 months divided by the total number of evaluable patients. A confidence interval for the 6-month survival rate was calculated using the exact binomial method.|Up to 6 months|||percentage of patients||95% Confidence Interval|Number
773123|NCT00735943|Secondary|Percentage of Participants Showing Improvement in OCT in the Subgroup Which Were Not Treatment Naive|OCT, a noninvasive, noncontact, transpupillary imaging technology, was utilized to image retinal structures in vivo with a resolution of 10 to 17 microns. The anatomic layers within the retina, retinal thickness could be measured. Improvement in OCT parameters was defined as a reduction of more than or equal to 100 microns in the central macular thickness (Center subfield). Improvement in OCT parameters was measured based on this single parameter.|12 months or last follow-up visit before study termination|Subgroup analysis was not performed as the study was terminated due to slow rate of recruitment.||Percentage of participants|||Number
773124|NCT00735943|Secondary|Percentage of Participants Showing Improvement in OCT in the Subgroup Previously Treated by Other Therapy|OCT, a noninvasive, noncontact, transpupillary imaging technology, was utilized to image retinal structures in vivo with a resolution of 10 to 17 microns. The anatomic layers within the retina, retinal thickness could be measured. Improvement in OCT parameters was defined as a reduction of more than or equal to 100 microns in the central macular thickness (Center subfield). Improvement in OCT parameters was measured based on this single parameter.|12 months or last follow-up visit before study termination|Subgroup analysis was not performed as the study was terminated due to slow rate of recruitment.||Percentage of participants|||Number
773125|NCT00735943|Secondary|Percentage of Participants Showing Stabilization or Improvement in VA in the Subgroup Previously Treated by Other Therapy|VA was measured using ETDRS chart at 4 meter distance, at 1 meter distance (if patient’s VA was poor) or verifying if the patient was able only to count fingers, to perceive hand motion or light. VA was measured as the number of ETDRS letters correctly read. VA statuses were defined as: stabilization: loss of less than 15 letters in the BCVA; improvement: gain of more than 15 letters in the BCVA.|12 months or last follow-up visit before study termination|Subgroup analysis was not performed as the study was terminated due to slow rate of recruitment.||Percentage of participants|||Number
773126|NCT00735943|Secondary|Percentage of Participants Who Were Treatment Naive When Started on Macugen Versus Those Previously Treated by Any Other Therapy Except Macugen|Participants were considered treatment naive when started on Macugen and without any previous drug or non drug treatment administered to the study eye. Participants were considered previously treated by any other therapy if received any other drug or non drug treatment to the study eye except Macugen.|12 months or last follow-up visit before study termination|Subgroup analysis was not performed as the study was terminated due to slow rate of recruitment.||Percentage of participants|||Number
773127|NCT00735943|Secondary|Percentage of Participants With Occult or Minimally Classic and Classic Lesions Showing Stabilization and Improvement in VA|FFA was utilized to characterize the lesions as follows: Classic lesion: more than 50% of the lesion had a well-demarcated area of hyperfluorescence; minimally classic lesion: less than or equal to 50% of lesion had well-demarcated area of hyperfluorescence; occult lesion: lesion with no well demarcated borders. VA statuses were defined as: stabilization: loss of less than 15 letters in the BCVA; improvement: gain of more than or equal to 15 letters in the BCVA.|12 months or last follow-up visit before study termination|Subgroup analysis was not performed as the study was terminated due to slow rate of recruitment.||Percentage of participants|||Number
773168|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Sodium|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 130 mmol/L (decrease) or a value greater than 160 mmol/L (increase).|78 weeks|Treated Set with values for Sodium||participants|||Number
773128|NCT00735943|Secondary|Median Number of Injections to Achieve Stabilization of VA in Participants With Early Lesions|Stabilization of VA was defined as loss of less than 15 letters in the BCVA. Median number of injections to achieve stabilization of VA in participants with early lesions was estimated via the Kaplan Meier method. For each participant, number of injections before reaching the first “stabilization in VA” (considered as an event) was counted. For participant having no event, the time to the number of injections to reach an event was unobserved at the number of injections before the last follow up.|12 months or last follow-up visit before study termination|Subgroup analysis was not performed as the study was terminated due to slow rate of recruitment.||injections||Full Range|Median
773129|NCT00735943|Secondary|Average Number of Injections to Achieve Stabilization of VA in Participants With Early Lesions|Stabilization of VA was defined as loss of less than 15 letters in the BCVA. For each participant, number of injections before reaching the first “stabilization in VA” (considered as an event) was counted. For participant having no event, the time to the number of injections to reach an event was unobserved at the number of injections before the last follow up.|12 months or last follow-up visit before study termination|Subgroup analysis was not performed as the study was terminated due to slow rate of recruitment.||injections|||Number
773130|NCT00735943|Secondary|Percentage of Participants With Early Lesions Showing Stabilization and Improvement of VA|Early lesions were defined by any 2 of the following criteria: occult lesion diagnosed on FFA; baseline VA of more than or equal to 54 ETDRS letters; lesion size of less than 2DA on FFA. Stabilization of VA was defined as loss of less than 15 letters in the BCVA. Improvement in the VA was defined as gain of more than or equal to 15 letters in the BCVA.|12 months or last follow-up visit before study termination|Subgroup analysis was not performed as the study was terminated due to slow rate of recruitment.||Percentage of participants|||Number
773131|NCT00735943|Secondary|Percentage of Participants Showing Improvement in Fundus Fluorescein Angiography (FFA) Parameters|A fluorescein angiogram provides information about the condition of the retina. Improvement in FFA parameters was defined as absence of progression of the lesion or decrease in the size of the lesion and absence of new lesions on FFA i.e. change in lesion size from baseline must be less than or equal to 0 disc area(DA) and no new lesions.|12 months or last follow-up visit before study termination|Due to small sample size, the analysis was not conducted.||Percentage of participants|||Number
773132|NCT00735943|Secondary|Percentage of Participants Showing Improvement in Optical Coherence Tomography (OCT) Parameters|OCT, a noninvasive, noncontact, transpupillary imaging technology, was utilized to image retinal structures in vivo with a resolution of 10 to 17 microns. The anatomic layers within the retina, retinal thickness could be measured. Improvement in OCT parameters was defined as a reduction of more than or equal to 100 microns in the central macular thickness (Center subfield).|12 months or last follow-up visit before study termination|FAS included all participants who received at least 1 injection of the study treatment in the study eye during the study. Missing values were imputed by LOCF technique.||Percentage of participants|||Number
773133|NCT00735943|Secondary|Percentage of Participants Receiving Macugen Monotherapy Versus Those Receiving a Combination Therapy|Macugen monotherapy: referred to participants receiving Macugen in the study eye during the study that is (i.e.) participants without any concomitant drug treatment or nondrug treatment for the study eye during the study. Combination therapy: referred to participants receiving combination therapy in the study eye (during the study) i.e. participants with any concomitant drug treatment or nondrug treatment for the study eye during the study.|12 months or last follow-up visit before study termination|FAS included all participants who received at least 1 injection of the study treatment in the study eye during the study. Missing values were imputed by LOCF analysis.||Percentage of participants|||Number
773134|NCT00735943|Primary|Median Number of Injections to Achieve Stabilization of VA|Stabilization of VA was defined as loss of less than 15 letters in the BCVA. Median number of injections to achieve stabilization of VA was estimated via the Kaplan Meier method. For each participant, number of injections before reaching the first “stabilization in VA” (considered as an event) was counted. For participant having no event, the time to the number of injections to reach an event was unobserved at the number of injections before the last follow up.|12 months or last follow-up visit before study termination|FAS included all participants who received at least 1 injection of the study treatment in the study eye during the study. Missing values were imputed by LOCF technique. Analysis was conducted for those participants who received at least 1 injection of the study treatment in the study eye and achieved stabilization at the last follow-up.||injections||Full Range|Median
773135|NCT00735943|Primary|Average Number of Injections to Achieve Stabilization of VA|Stabilization of VA was defined as loss of less than 15 letters in the BCVA. For each participant, number of injections before reaching the first “stabilization in VA” (considered as an event) was counted. For participant having no event, the time to the number of injections to reach an event was unobserved at the number of injections before the last follow up.|12 months or last follow-up visit before study termination|FAS included all participants who received at least 1 injection of the study treatment in the study eye during the study. Missing values were imputed by LOCF technique. Analysis was conducted for those participants who received at least 1 injection of the study treatment in the study eye and achieved stabilization at the last follow-up.||injections||Standard Deviation|Mean
773136|NCT00735943|Primary|Percentage of Participants Showing Stabilization, Improvement or Deterioration of Visual Acuity (VA)|VA was measured using ETDRS (Early Treatment Diabetic Retinopathy Study) chart at 4 meter distance, at 1 meter distance (if participant's VA was poor) or verifying if the participant was able only to count fingers, to perceive hand motion or light. VA was assessed as the number of ETDRS letters correctly read. VA statuses were defined as: Stabilization: loss of less than 15 letters in the best corrected VA (BCVA); Improvement: gain of more than or equal to 15 letters in the BCVA; Deterioration: loss of more than or equal to 15 letters in the BCVA.|Baseline through 12 months or last follow-up visit before study termination|Full Analysis Set (FAS) included all participants who received at least 1 injection of the study treatment in the study eye during the study. Missing values were imputed by Last Observation Carried Forward (LOCF) technique.||percentage of participants|||Number
773137|NCT00735969|Primary|Sustained Virological Response, (HCV RNA Neg.) in Serum 24 Weeks Off Therapy.||24 weeks after treatment stop|||participants|||Number
773169|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Calcium|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 1.8 mmol/L (decrease) or a value greater than 3 mmol/L (increase).|78 weeks|Treated Set with values for Calcium||participants|||Number
773139|NCT00736034|Primary|Change From Baseline in Neuropsychological Computerized Test|The computerized neuropsychological assessment software consists of seven separate tasks: symbol spotting, pattern identification, pattern recall, digit-symbol substitution, digits span forward, digits span backward and delayed pattern recall. Based on the results obtained in the single tasks, eight cognitive composite scores are calculated including focused attention, sustained attention, memory recognition & recall, visuospatial learning, spatial short term memory, executive functions and mental flexibility.The total score range is from 0 to 100 points(0 is worse, 100 is best).|baseline, 15 weeks|||Points on a scale||Standard Deviation|Mean
773140|NCT00736073|Secondary|Number of Participants Who Were Hospitalized Within 7 Days Post-ERCP for Abdominal Pain That Did Not Meet Criteria for Acute Pancreatitis||7 days|||participants|||Number
773141|NCT00736073|Secondary|Incidence of Pain Post-ERCP, Within 48 Hours of ERCP, and at 1 Week Post-ERCP; Unrelated to Pancreatitis||48 hours post ERCP and 1 week post ERCP|There are 2 telephone assessments that participants are required to complete in order to analyze the outcome measure. The study team was unable to collect both assessments within the required timeframe due missed calls & lack of return calls from participants. Therefore data collection and analysis could not be completed per protocol.|||||
773142|NCT00736073|Primary|Number of Post-ERCP Pancreatitis Cases in Participants Who Are Administered Aprepitant and Placebo Prior to ERCP and One Day After ERCP:Assess the Total Number of Incidents of Post-ERCP Pancreatitis in Each Group (Treatment and Control).||48 hours|The number of participants who received the aprepitant or placebo were evaluated for ERCP pancreatitis. Each case of ERCP pancreatitis was tracked for the participant.||cases of ERCP in participants|||Number
773143|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Cholesterol|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 300 mg/dL.|78 weeks|Treated Set with values for Cholesterol||participants|||Number
773144|NCT00736099|Secondary|Change in FPG From Baseline to Week 78||Baseline and week 78|Treated Set with values for FPG at baseline and at week 78. Values after rescue therapy are set to missing.||mg/dL||Standard Deviation|Mean
773145|NCT00736099|Secondary|Change in FPG From Baseline to Week 66||Baseline and week 66|Treated Set with values for FPG at baseline and at week 66. Values after rescue therapy are set to missing.||mg/dL||Standard Deviation|Mean
773146|NCT00736099|Secondary|Change in FPG From Baseline to Week 54||Baseline and week 54|Treated Set with values for FPG at baseline and at week 54. Values after rescue therapy are set to missing.||mg/dL||Standard Deviation|Mean
773147|NCT00736099|Secondary|Change in FPG From Baseline to Week 42||Baseline and week 42|Treated Set with values for FPG at baseline and at week 42. Values after rescue therapy are set to missing.||mg/dL||Standard Deviation|Mean
773148|NCT00736099|Secondary|Change in FPG From Baseline to Week 30||Baseline and week 30|Treated Set with values for FPG at baseline and at week 30. Values after rescue therapy are set to missing.||mg/dL||Standard Deviation|Mean
773149|NCT00736099|Secondary|Change in FPG From Baseline to Week 18||Baseline and week 18|Treated Set with values for FPG at baseline and at week 18. Values after rescue therapy are set to missing.||mg/dL||Standard Deviation|Mean
773150|NCT00736099|Secondary|Change in FPG From Baseline to Week 6||Baseline and week 6|Treated Set with values for FPG at baseline and at week 6. Values after rescue therapy are set to missing.||mg/dL||Standard Deviation|Mean
773151|NCT00736099|Secondary|Number of Patients With Lowered HbA1c by at Least 0.5% Over Time||78 weeks|Treated Set with values for HbA1c at baseline and week 78. Values after rescue therapy are set to missing.||participants|||Number
773152|NCT00736099|Secondary|Number of Patients With HbA1c<6.5% Over Time||78 weeks|Treated Set with values for HbA1c at baseline and week 78. Values after rescue therapy are set to missing.||participants|||Number
773153|NCT00736099|Secondary|Number of Patients With HbA1c<7.0% Over Time||78 weeks|Treated Set with values for HbA1c at baseline and week 78. Values after rescue therapy are set to missing.||participants|||Number
773154|NCT00736099|Secondary|Change in HbA1c From Baseline to Week 78||Baseline and week 78|Treated Set with values for HbA1c at baseline and week 78. Values after rescue therapy are set to missing.||percent||Standard Deviation|Mean
773155|NCT00736099|Secondary|Change in HbA1c From Baseline to Week 66||Baseline and week 66|Treated Set with values for HbA1c at baseline and week 66. Values after rescue therapy are set to missing.||percent||Standard Deviation|Mean
773156|NCT00736099|Secondary|Change in HbA1c From Baseline to Week 54||Baseline and week 54|Treated Set with values for HbA1c at baseline and week 54. Values after rescue therapy are set to missing.||percent||Standard Deviation|Mean
773157|NCT00736099|Secondary|Change in HbA1c From Baseline to Week 42||Baseline and week 42|Treated Set with values for HbA1c at baseline and week 42. Values after rescue therapy are set to missing.||percent||Standard Deviation|Mean
773158|NCT00736099|Secondary|Change in HbA1c From Baseline to Week 30||Baseline and week 30|Treated Set with values for HbA1c at baseline and week 30. Values after rescue therapy are set to missing.||percent||Standard Deviation|Mean
773159|NCT00736099|Secondary|Change in HbA1c From Baseline to Week 18||Baseline and week 18|Treated Set with values for HbA1c at baseline and week 18. Values after rescue therapy are set to missing.||percent||Standard Deviation|Mean
773160|NCT00736099|Secondary|Change in HbA1c From Baseline to Week 6||Baseline and week 6|Treated Set with values for HbA1c at baseline and week 6. Values after rescue therapy are set to missing.||percent||Standard Deviation|Mean
773161|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Lactate Dehydrogenase (LDH)|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.|78 weeks|Treated Set with values for LDH||participants|||Number
773162|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Albumin|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 2.5 g/dL.|78 weeks|Treated Set with values for Albumin||participants|||Number
773163|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Alkaline Phosphatase (AP)|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 2 times the ULN.|78 weeks|Treated Set with values for AP||participants|||Number
773164|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Bilirubin|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 2 mg/dL.|78 weeks|Treated Set with values for Bilirubin||participants|||Number
773170|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Phosphate|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 0.7 mmol/L (decrease) or a value greater than 1.7 mmol/L (increase).|78 weeks|Treated Set with values for Phosphate||participants|||Number
773171|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Creatinine Kinase|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.|78 weeks|Treated Set with values for Creatinine kinase||participants|||Number
773172|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Creatinine|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 1.5 mg/dL.|78 weeks|Treated Set with values for Creatinine||Participants|||Number
773173|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: γ-Glutamyl-transferase (GGT)|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.|78 weeks|Treated Set with values for GGT||Participants|||Number
773174|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Amylase|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 1.5 times the upper limit of normal (ULN).|78 weeks|Treated Set with values for Amylase||Participants|||Number
773175|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Triglycerides|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 300 mg/dL.|78 weeks|Treated Set with values for Triglycerides||Participants|||Number
773176|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Uric Acid|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 11 mg/dL for male and as a value greater than 10 mg/dL for female patients.|78 weeks|Treated Set with values for Uric acid||Participants|||Number
773177|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Potassium|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 3 mmol/L (decrease) or a value greater than 5.8 mmol/L (increase).|78 weeks|Treated Set with values for Potassium||participants|||Number
773178|NCT00736099|Primary|Number of Patients With Abnormalities in Haematology: Platelets|For this laboratory parameter, a possibly clinically significant abnormality is defined as value less than or equal to 75 * 10^9/L (decrease) or a value greater than or equal to 700 * 10^9/L (increase).|78 weeks|Treated Set with values for Platelets||Participants|||Number
773179|NCT00736099|Primary|Number of Patients With Abnormalities in Haematology: White Blood Cell Count|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 3 * 10^9/L (decrease) or a value greater than 20.1 * 10^9/L (increase).|78 weeks|Treated Set with values for White blood cell count||Participants|||Number
773180|NCT00736099|Primary|Number of Patients With Abnormalities in Haematology: Red Blood Cell Count|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 3 * 10^12/L.|78 weeks|Treated Set with values for Red blood cell count||Participants|||Number
773181|NCT00736099|Primary|Number of Patients With Abnormalities in Haematology: Haematocrit|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than or equal to 32%.|78 weeks|Treated Set with values for Haematocrit||Participants|||Number
773182|NCT00736099|Primary|Number of Patients With Abnormalities in Haematology: Haemoglobin|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than or equal to 11.5 g/dL for male and as a value less than or equal to 9.5 g/dL for female patients.|78 weeks|Treated Set with values for Haemoglobin||Participants|||Number
773183|NCT00736099|Primary|Number of Patients With Abnormalities in Haematology: Eosinophils|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 10%.|78 weeks|Treated Set with values for Eosinophils||participants|||Number
773184|NCT00736099|Primary|Number of Patients With Abnormalities in Vital Signs|Vital sign abnormalities (any abnormalities found during PE or ECG are reported with adverse events)|78 weeks|Treated Set: all screened patients who were documented to have taken at lease 1 dose of study drug.||Participants|||Number
773185|NCT00736099|Primary|Frequency of Patients With Adjudication of Cardiac and Cerebrovascular Events|Patients reported with cardiac and cerebrovascular events qualified for adjudication by the Clinical Event Committee (CEC)|78 weeks|Treated Set: all screened patients who were documented to have taken at least 1 dose of study drug||participants|||Number
773186|NCT00736099|Primary|Frequency of Patients With Significant Adverse Events Based on Standardised MedDRA Query (SMQ)|As significant adverse events are considered: renal Aes (SMQ 'acute renal failure'), hypersensitivity reactions ('anaphylactic reactions' and 'angioedema'), hepatic Aes ('hepatitis, non-infectious', 'hepatic failure, fibrosis, cirrhosis and other liver damage-related conditions', 'liver-related investigations, signs and symptoms', 'cholestasis and jaundice of hepatic origin'), severe cutaneous adverse reactions ('severe cutaneous adverse reaction'), pancreatitis ('acute pancreatitis', 'chronic pancreatitis'').|78 weeks|Treated Set: all screened patients who were documented to have taken at lease 1 dose of study drug.||Participants|||Number
773187|NCT00736099|Primary|Frequency of Patients With Investigator-defined Hypoglycaemic Adverse Events||78 weeks|Treated Set: all screened patients who were documented to have taken at lease 1 dose of study drug.||Participants|||Number
773188|NCT00736099|Primary|Frequency of Patients With Adverse Events (AEs)|This includes any AEs detected during routine physical examination and electrocardiogram (ECG) procedures.|78 weeks|Treated Set: all screened patients who were documented to have taken at lease 1 dose of study drug.||Participants|||Number
773189|NCT00736125|Secondary|Biomarkers of Neuronal Damage||Within 72 hours after surgery||||||
773190|NCT00736125|Secondary|Systemic Inflammatory Response (SIRS) Markers||Within 72 hours after surgery||||||
773191|NCT00736125|Secondary|Cardiac Injury||Within 3 days after surgery||||||
773192|NCT00736125|Secondary|Changes in Pulmonary and Renal Function||Within 3 days after surgery||||||
773193|NCT00736125|Secondary|Delirium During Hospital Stay||First 3 days after surgery||||||
773194|NCT00736125|Secondary|Changes in Neurocognitive Tests Following Surgery||2 weeks prior to 1 year following surgery||||||
773195|NCT00736125|Secondary|Number of Patients With Emboli in the High Category||During surgery|||Patients w/ emboli in high category|||Number
773197|NCT00724568|Secondary|The Percentage of Patients That Achieved Partial or Complete Response to Treatment.|"Partial Response:
50% reduction in the level of serum monoclonal protein for at least two determinations six weeks apart.
If present, reduction in 24-hour urinary light chain excretion by either, greater than or equal to 90%, or to <200 mg for at least two determinations six weeks apart.
50% reduction in the size of soft tissue plasmacytomas (by clinical or radiographic examination) for at least six weeks.
No increase in size or number of lytic bone lesions (development of compression fracture does not exclude response).
Complete Response:
Disappearance of the original monoclonal protein from the blood and urine on at least two determinations for a minimum of six weeks.
<5% plasma cells in the bone marrow on at least two determinations for a minimum of six weeks.
No increase in the size or number of lytic bone lesions."|24 weeks (8, 21-day cycles)|74 patients were enrolled, but 2 were not evaluable for dose limiting toxicities. 72 patients were included in this analysis.||percentage of patients|||Number
773198|NCT00724568|Primary|Maximum Tolerated Dose (MTD) of Combination Therapy With VELCADE, Dexamethasone, and Doxil, (RVDD)|"Dose Level 1:
15 mg Revlimid daily on days 1-14 followed by 7-day rest every 21 days 1.3 mg/m2 Velcade daily on days 1, 4, 8 and 11 20 mg dexamethasone daily on Days 1, 2, 4, 5, 8, 9, 11, 12* and 20 mg/m2 Doxil daily on day 4
Dose Level 2:
20 mg Revlimid daily on days 1-14 followed by 7-day rest every 21 days 1.3 mg/m2 Velcade daily on days 1, 4, 8 and 11 20 mg dexamethasone daily on Days 1, 2, 4, 5, 8, 9, 11, 12* and 20 mg/m2 Doxil daily on day 4
Dose Level 3:
25 mg Revlimid daily on days 1-14 followed by 7-day rest every 21 days 1.3 mg/m2 Velcade daily on days 1, 4, 8 and 11 20 mg dexamethasone daily on Days 1, 2, 4, 5, 8, 9, 11, 12* and 20 mg/m2 Doxil daily on day 4
Dose Level 4:
25 mg Revlimid daily on days 1-14 followed by 7-day rest every 21 days 1.3 mg/m2 Velcade daily on days 1, 4, 8 and 11 20 mg dexamethasone daily on Days 1, 2, 4, 5, 8, 9, 11, 12* and 30 mg/m2 Doxil daily on day 4"|1 month post treatment|A total of 74 patients were enrolled in this phase 1/2 study: 42 in phase 1.||mg|||Number
773199|NCT00724594|Primary|PT||prior to delivery and in newborn DOL1||||||
773200|NCT00724594|Primary|Cerebral Blood Flow||prior to delivery and in newborn after delivery, during 2 days of NAC infusion||||||
773201|NCT00724594|Primary|Maternal and Infant Mean Blood Pressure Change||Maternal mean BP changes were pre/post dosing prior to delivery. Infant measurements were pre/post their first dosing|The infant and maternal populations analyzed for this portion are incomplete, as not all individuals had paired before/after blood pressure measurements at this time point.||mmHg||Standard Deviation|Mean
773202|NCT00724594|Primary|Placental Transfer Ratio|Ratio of NAC concentration in cord to maternal venous blood|At time of delivery|||ratio||Standard Deviation|Mean
773203|NCT00724594|Secondary|Cytokine Levels in Plasma and CSF||During 2 days of NAC infusion||||||
773204|NCT00724594|Primary|NAC Concentrations||Peak: 30 minutes after NAC infusion. Cord: at delivery|||micromol/L||Standard Deviation|Mean
773205|NCT00724594|Primary|NAC Total Body Clearance||prior to delivery in mothers, and in newborn after delivery during 2 days of NAC infusion|||mL/h/kg||Standard Deviation|Mean
773206|NCT00724594|Primary|NAC Volume of Distribution||prior to delivery in mothers, and in newborn after delivery during 2 days of NAC infusion|||L/kg||Standard Deviation|Mean
773207|NCT00724594|Secondary|Magnetic Resonance Spectroscopy of Infants||36 - 40 weeks gestational age||||||
773208|NCT00724594|Primary|NAC Terminal Elimination Half-life||prior to delivery in mothers, and in newborn after delivery during 2 days of NAC infusion|||hours||Standard Deviation|Mean
773209|NCT00724698|Primary|Adverse Events|Number of adverse events reported|Final Visit (Day 15)|||adverse events reported|||Number
773210|NCT00724711|Secondary|Change From Baseline Interleukin-6 (IL-6), Interleukin-10 (IL-10), and Tumor Necrosis Factor-alpha (TNF-alpha) at Week 48|Change = Week 48 value minus baseline value|Baseline to 48 weeks|"Treated Analysis Set, Subset of Participants Enrolled after Amendment 3
Missing = Excluded"||pg/mL||Standard Deviation|Mean
773211|NCT00724711|Secondary|Change From Baseline Fibrinogen at Week 48|Change = Week 48 value minus baseline value|Baseline to 48 weeks|"Treated Analysis Set, Subset of Subjects Enrolled after Amendment 3
Missing = Excluded"||mg/dL||Standard Deviation|Mean
773212|NCT00724711|Secondary|Change From Baseline C-Reactive Protein at Week 48|Change = Week 48 value minus baseline value|Baseline to 48 weeks|"Treated Analysis Set, Subset of Subjects Enrolled after Amendment 3
Missing = Excluded"||mg/dL||Standard Deviation|Mean
773213|NCT00724711|Secondary|Change From Baseline Ratio of Fasting Total Cholesterol Over High-density Lipoprotein (HDL) Cholesterol at Week 48|Change = Week 48 value minus baseline value|Baseline to 48 weeks|Treated Analysis Set||Ratio||Standard Deviation|Mean
773214|NCT00724711|Secondary|Change From Baseline Fasting Lipid Parameters at Week 48|Change = Week 48 value minus baseline value|Baseline to 48 weeks|Treated Analysis Set||mg/dL||Standard Deviation|Mean
773215|NCT00724711|Secondary|Change From Baseline Fasting Glucose at Week 48|Change = Week 48 value minus baseline value|Baseline to 48 weeks|Treated Analysis Set||mg/dL||Standard Deviation|Mean
773216|NCT00724711|Secondary|Change From Baseline Estimated Glomerular Filtration Rate (eGFR) by Modified Diet in Renal Disease (MDRD) at Week 48|Change = Week 48 value minus baseline value|Baseline to 48 weeks|Treated Analysis Set||mL/min/1.73m^2||Standard Deviation|Mean
773217|NCT00724711|Secondary|Change From Baseline Calculated Creatinine Clearance (CLcr) Using Ideal Body Weight by Cockcroft-Gault Method at Week 48|Change = Week 48 value minus baseline value|Baseline to 48 weeks|Treated Analysis Set: The treated analysis set included all randomized participants who received at least one dose of study drug. Participants who were randomized to continue ABC/3TC+PI/r during the study were included in the treated analysis set if they took at least one dose of their study drug after the baseline visit.||mL/min||Standard Deviation|Mean
773218|NCT00724711|Secondary|Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 48|Change = Week 48 value minus baseline value|Baseline to 48 weeks|"ITT Analysis Set
Missing = Excluded: Participants with missing values were excluded from this analysis"||cells/microliter||Standard Deviation|Mean
773219|NCT00724711|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was summarized.|48 weeks|"ITT analysis set
TLOVR: No virologic rebound on or before Week 48; no discontinuation before Week 48; no new ARV by study completion
Missing = Failure: Participants with missing values considered to have HIV-1 RNA levels >= 50 copies/mL
Virologic Success: Last available HIV-1 RNA < 50 copies/mL in Week 48 window on randomized treatment"||percentage of participants|||Number
773220|NCT00724711|Secondary|Percentage of Participants With HIV-1 RNA < 200 Copies/mL at Week 48|The percentage of participants with HIV-1 RNA < 200 copies/mL at Week 48 was summarized.|48 weeks|"ITT analysis set
Missing = Failure: Participants with missing values considered to have HIV-1 RNA levels >= 200 copies/mL
Virologic Success: Last available HIV-1 RNA < 200 copies/mL in the Week 48 window while on randomized treatment"||percentage of participants|||Number
773221|NCT00724711|Secondary|Percentage of Participants With Pure Virologic Response (PVR) for HIV-1 RNA Cutoff at 50 Copies/mL Through Week 48|The percentage of participants with PVR for HIV-1 RNA cutoff at 50 copies/mL at Week 48 was summarized. Pure virologic response was the proportion of participants who did not have a virologic rebound. Virologic rebound was defined as two consecutive HIV-1 RNA values >= 50 copies/mL or the last HIV-1 RNA value >= 50 copies/mL followed by discontinuation from the study.|Baseline to 48 weeks|ITT Analysis Set||percentage of participants|||Number
773222|NCT00724711|Secondary|Percentage of Participants With Pure Virologic Response (PVR) for HIV-1 RNA Cutoff at 200 Copies/mL Through Week 48|The percentage of participants with PVR for HIV-1 RNA cutoff at 200 copies/mL at Week 48 was summarized. Pure virologic response was the percentage of subjects who did not have a virologic rebound. Virologic rebound was defined as two consecutive HIV-1 RNA values >= 200 copies/mL or the last HIV-1 RNA value >= 200 copies/mL followed by discontinuation from the study.|Baseline to 48 weeks|ITT Analysis Set||percentage of participants|||Number
773223|NCT00724711|Primary|Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) < 200 Copies/mL Through Week 48 Based on Time to Loss of Virologic Response (TLOVR) Algorithm|The percentage of participants with HIV-1 RNA < 200 copies/mL based on TLOVR algorithm at Week 48 was summarized. Participants were considered nonresponders in the TLOVR analysis if they experienced virologic rebound prior to or at Week 48, discontinued study before Week 48, or added a new antiretroviral (ARV) agent prior to completion of the study. Virologic rebound was defined as 2 consecutive HIV-1 RNA values >= 200 copies/mL or the last HIV-1 RNA value >= 200 copies/mL followed by discontinuation from the study.|Baseline to 48 weeks|Intent-to-treat (ITT) Analysis Set: Participants who were treated with at least one dose of study drug with no documented resistance to study drug prior to screening.||percentage of participants|||Number
773224|NCT00724750|Secondary|Average Cost of Supplies and Rental|Direct costs for each type of dressing were measured. In the VAC group, this included rental charges for the equipment and the cost of supplies. In the G-SUC group, this included the cost of supplies (suction canisters, catheters or drains, tubing, gauze, and adhesive drapes).|Participants were followed for the duration of inpatient stay, an average of 5 days.|||dollars||Standard Deviation|Mean
773225|NCT00724750|Secondary|Pain Score With Dressing Changes|Self-reported pain levels were used to assess pain. Patients were asked to rate their pain level according to the 0 to 10 linear analog scale immediately before, during, and after removal of the dressing. The average number of dressing changes for the G-SUC group was 4.5 (range 2-15) and the average number of dressing changes for the VAC group was 2.8 (range 2-6). The sum of pain intensity differences (SPID) was used to facilitate comparison of pain levels. The SPID score was calculated for each dressing change using the formula: (pain during - pain before) + (pain after - pain during). Higher values indicating greater pain.|Participants were followed for the duration of inpatient stay, an average of 5 days.|||units on a scale||95% Confidence Interval|Mean
773226|NCT00724750|Secondary|Average Time Spent on Dressing Changes|Time was measured from the start of the dressing change until the initiation of suction.|Participants were followed for the duration of inpatient stay, an average of 5 days.|||minutes||Standard Deviation|Mean
773227|NCT00724750|Secondary|Failure to Maintain Dressing Because of Fluid or Suction Leaks||Participants were followed for the duration of inpatient stay, an average of 5 days.|||participants|||Number
773228|NCT00724750|Primary|Percent Change Per Day in Wound Volume|Wound volume was measured daily. The percent change from Day 1 was calculated. A negative value indicates a decrease.|7 days|||% change per day||95% Confidence Interval|Mean
773229|NCT00724750|Primary|Percent Change Per Day in Wound Surface Area|Wound surface area was measured daily. The percent change from Day 1 was calculated. A negative value indicates a decrease.|7 days|||% change per day||95% Confidence Interval|Mean
773230|NCT00730132|Primary|Percentage of Relative Change of LDL-C Level Measured on Visit 2 Compared With the Baseline (Visit 1) in Each of the Three Therapy Groups||Visit 2 (Month 2, end of observation) and Visit 1 (Day 0, baseline)|The efficacy analysis set (n=557) included all enrolled subjects, by treatment (after treatment modification), who received at least one dose of the modified lipid-lowering treatment and for whom no protocol deviations were recorded. One subject each from the Ezetimibe and New Statin groups were excluded from this analysis due to missing data.||mmol/L||Standard Deviation|Mean
773231|NCT00730132|Primary|Percentage of Relative Change of Total Cholesterol (TC) Level Measured on Visit 2 Compared With the Baseline (Visit 1) in Each of the Three Therapy Groups||Visit 2 (Month 2, end of observation) and Visit 1 (Day 0, baseline)|The efficacy analysis set (n=557) included all enrolled subjects, by treatment (after treatment modification), who received at least one dose of the modified lipid-lowering treatment and for whom no protocol deviations were recorded. One subject each from the Ezetimibe and New Statin groups were excluded from this analysis due to missing data.||mmol/L||Standard Deviation|Mean
773232|NCT00730132|Primary|Percentage of Patients Per Group Who Reached Goal for Low Density Lipoprotein (LDL-C) (< 2.6 mmol/L) According to ARSCS Recommendations by End of Observation||Visit 2 (Month 2, end of observation)|The efficacy analysis set (n=557) included all enrolled subjects, by treatment (after treatment modification), who received at least one dose of the modified lipid-lowering treatment and for whom no protocol deviations were recorded.||Percentage of patients|||Number
773233|NCT00730132|Primary|Percentage of Patients Per Group Who Reach Goal for Total Cholesterol (TC) (< 4.5 mmol/L) According to All-Russian Scientific Cardiologists Society (ARSCS) Recommendations by End of Observation|Statins included in this outcome measure included: 1. statin dose (atorvastatin, fluvastatin, rosuvastatin, simvastatin) titration. 2. shift to a different (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastin, simvastatin) statin . 3. Ezetimibe added to existing statin (atorvastatin, lovastatin, rosuvastatin, simvastatin).|Visit 2 (Month 2, end of observation)|The efficacy analysis set (n=557) included all enrolled subjects, by treatment (after treatment modification), who received at least one dose of the modified lipid-lowering treatment and for whom no protocol deviations were recorded. One subject each from the Ezetimibe and New Statin groups were excluded from this analysis due to missing data.||Percentage of patients|||Number
773234|NCT00730132|Primary|Percentage of Patients Receiving Each Variant of Modified Lipid-lowering Therapy: Statin Dose Titration, Administration of a New Statin, Administration of a Ezetimibe in Addition to a Current Statin.|Statins included: 1. statin dose (atorvastatin, fluvastatin, rosuvastatin, simvastatin) titration . 2. shift to a (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastin, simvastatin) different statin . 3. Ezetimibe added to existing statin (atorvastatin, lovastatin, rosuvastatin, simvastatin).|During the study|The efficacy analysis set (n=557) included all enrolled subjects, by treatment (after treatment modification), who received at least one dose of the modified lipid-lowering treatment and for whom no protocol violations were recorded. One subject each from ezetimibe added to existing statin and new statin group were excluded (missing data)||Percentage of patients|||Number
773235|NCT00730236|Secondary|Absolute Change From Baseline in Weight|Absolute change from Baseline in weight|Baseline and Week 78|All patients treated||kg||Standard Deviation|Mean
773236|NCT00730236|Secondary|Absolute Change From Baseline in Total Bilirubin|Absolute change from Baseline in total bilirubin|Baseline and Week 78|All patients treated||mg/dL||Standard Deviation|Mean
773237|NCT00730236|Secondary|Absolute Change From Baseline in Aspartate Aminotransferase (AST)|Absolute change from Baseline in AST|Baseline and Week 78|All patients treated||U/L||Standard Deviation|Mean
773238|NCT00730236|Secondary|Absolute Change From Baseline in Alanine Aminotransferase (ALT)|Absolute change from Baseline in ALT|Baseline and Week 78|All patients treated||U/L||Standard Deviation|Mean
773239|NCT00730236|Secondary|Absolute Change From Baseline in Hepatic Fat Percent|Absolute change from Baseline in hepatic fat percent|Baseline and Week 78|All patients treated||Percent Hepatic Fat||Standard Deviation|Mean
773240|NCT00730236|Secondary|Percent Change From Baseline in Apolipoprotein AI (Apo AI)|Percent change from Baseline in Apo AI|Baseline and Week 26|ITT Population||Percent Change||Standard Deviation|Mean
773241|NCT00730236|Secondary|Percent Change From Baseline in Non-HDL-C|Percent change from Baseline in non-HDL-C|Baseline and Week 26|ITT Population||Percent Change||Standard Deviation|Mean
773242|NCT00730236|Secondary|Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C)|Percent change from Baseline in HDL-C|Baseline and Week 26|ITT Population||Percent Change||Standard Deviation|Median
773243|NCT00730236|Secondary|Percent Change From Baseline in Triglycerides|Percent change from Baseline in triglycerides|Baseline and Week 26|ITT Population||Percent Change||Standard Deviation|Mean
773244|NCT00730236|Secondary|Percent Change From Baseline for Apolipoprotein B (Apo B)|Percent change from Baseline for Apo B|Baseline and Week 26|ITT Population||Percent Change||Standard Deviation|Mean
773245|NCT00730236|Secondary|Percent Change From Baseline in Total Cholesterol (TC)|Percent change from Baseline in TC|Baseline and Week 26|ITT Population||Percent Change||Standard Deviation|Mean
773246|NCT00730236|Primary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)|Percent change from Baseline in LDL-C|Baseline and Week 26|Intention To Treat (ITT) Population||Percent Change||Standard Deviation|Mean
773247|NCT00730275|Secondary|Plasma Dipeptidyl Peptidase-4 (DPP-4) Activity Following a Single Dose of Sitagliptin or Placebo|"Plasma DPP-4 activity was analyzed using the 24-hour weighted average inhibition (WAI) and percent inhibition at 24 hours post-dose.
WAI was defined as the AUC of inhibition divided by the length of the post-dose time interval. Positive values of WAI represent a decrease in DPP-4 activity."|Pre-dose through 24 hours post-dose|All participants who received a single dose of sitagliptin or placebo.||Percent inhibition||95% Confidence Interval|Least Squares Mean
773248|NCT00730275|Secondary|Apparent Terminal Half-life (Apparent t1/2) Following a Single Dose of Sitagliptin|Serum samples were used to determine the apparent t1/2 for sitagliptin. The placebo group is not included in the table below; this outcome measure only evaluated the sitagliptin groups.|Pre-dose through 72 hours post-dose|All participants who received a single dose of sitagliptin 50 mg, 100 mg, or 200 mg.||hours||Standard Deviation|Mean
773249|NCT00730275|Secondary|Time of Occurence of Maximum Concentration (Tmax) Following a Single Dose of Sitagliptin|Serum samples were used to determine the Tmax for sitagliptin. The placebo group is not included in the table below; this outcome measure only evaluated the sitagliptin groups.|Pre-dose through 72 hours post-dose|All participants who received a single dose of sitagliptin 50 mg, 100 mg, or 200 mg.||hours||Full Range|Median
773250|NCT00730275|Secondary|Maximum Concentration (Cmax) Following a Single Dose of Sitagliptin|Serum samples were used to determine the Cmax for sitagliptin. The placebo group is not included in the table below; this outcome measure only evaluated the sitagliptin groups.|Pre-dose through 72 hours post-dose|All participants who received a single dose of sitagliptin 50 mg, 100 mg, or 200 mg.||nM||95% Confidence Interval|Geometric Mean
773251|NCT00730275|Primary|Area Under the Concentration-time Curve (AUC) From Time 0 to Infinity Following a Single Dose of Sitagliptin|Serum samples were used to determine the AUC from time 0 to infinity for sitagliptin. The placebo group is not included in the table below; this outcome measure only evaluated the sitagliptin groups.|Pre-dose through 72 hours post-dose|All participants who received a single dose of sitagliptin 50 mg, 100 mg, or 200 mg.||nM*hour||95% Confidence Interval|Geometric Mean
773252|NCT00730275|Primary|Number of Participants Who Experienced at Least One Adverse Event||Pre-study through 10 to 14 days following administration of study drug|All enrolled participants.||participants|||Number
773253|NCT00730327|Post-Hoc|Percent Total Body Weight Loss (%TBWL)|Post-Hoc effectiveness analyses were performed per the request of FDA after the study closed, therefore the protocol was not amended. The data was analyzed to determine participants' Percent Total Body Weight Loss (%TBWL) at key timepoints throughout the study. The mean %TBWL for the BIB and Control group was assessed at baseline, Week 26 (6 months, balloon removal for BIB group), Week 39 (9 months), and Week 52 (12, months, study completion).|Baseline, Week 26, Week 39, Week 52|Randomized participants in the ITT population with last observation carried forward. n=number of participants (number of participants varies as not all participants provided data at each timepoint).||percentage of TBWL||95% Confidence Interval|Mean
773266|NCT00730353|Primary|Progression Free Survival Rate at 24 Weeks|To determine the rate of non-progressive disease at 24 weeks from the first dose of the combination of sunitinib malate and paclitaxel in advanced esophageal carcinoma, where progression is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions|24 weeks|Intent to treat - all enrolled participants||percentage of participants||90% Confidence Interval|Number
773254|NCT00730327|Post-Hoc|Percent EWL (Using BMI=25 kg/m²)|"Post-Hoc effectiveness analyses were performed per the request of FDA after the study closed, therefore the protocol was not amended. The data was analyzed to determine participants' mean %EWL (using a BMI=25 kg/m² as ideal weight) at key timepoints. Participants' mean %EWL was assessed at Week 26 (6 months, balloon removal for BIB group), Week 39 (9 months), and Week 52 (12, months, study completion).
Percent EWL was calculated as %EWL= (weight loss divided by excess weight)*100, where Weight loss = Baseline weight - selected follow-up weight, and Excess weight = Baseline weight - ideal weight, where ideal weight was BMI=25."|Baseline, Week 26, Week 39, Week 52|Randomized participants in the ITT population with last observed carried forward (number of participants varies as not all participants provided data at each timepoint)||percentage of EWL||Standard Deviation|Mean
773255|NCT00730327|Post-Hoc|Change in BMI|Post-Hoc effectiveness analyses were performed per the request of FDA after the study closed, therefore the protocol was not amended. The data was analyzed to determine the change in participant's Body Mass Index (BMI) at key timepoints throughout the study. The mean BMI for the BIB and Control group was assessed at baseline, Week 26 (6 months, balloon removal for BIB group), Week 39 (9 months), and Week 52 (12, months, study completion).|Baseline, Week 26, Week 39, Week 52|Randomized participants in the ITT population who provided weight data at that visit. n=number of participants (number of participants varies as not all participants provided data at each timepoint).||kg/m²||Standard Deviation|Mean
773256|NCT00730327|Secondary|Change in Participant Depression (Beck Depression Inventory II)|Participants were assessed for depression using the Beck Depression Inventory II (BDI-II) questionnaire. The BDI-II consists of 21 questions to measure depressive symptoms and severity. The overall score ranges from 0-63, where higher total scores indicate more severe depressive symptoms. A total score of 0-13 is considered a minimal range, 14-19 is mild, 20-28 is moderate and 29-63 is interpreted as severe depressive symptoms. The mean BDI-II score for the BIB and control groups were assessed at baseline and at key timepoints: Week 26 (month 6, balloon removal for BIB group), Week 39 (month 9), and Week 52 (month 12, study completion).|Baseline, Week 26, Week 39, Week 52|Randomized participants in the ITT population that provided data at each visit. n=the number of participants (number of participants varies as not all participants completed the questionnaire at each visit)||units on a scale||Standard Deviation|Mean
773257|NCT00730327|Secondary|Change in Quality of Life (IWQOL-Lite)|The change in quality of life from baseline to 12 months was measured by the Impact of Weight on Quality of Life - Lite (IWQOL-Lite) questionnaire. IWQOL-Lite consists of 31 scale items to assess obesity-related quality of life, and total score ranges from 0 (worst) to 100 (best). The BIB group's mean IWQOL-Lite score at baseline, Week 26 (6 months, balloon removal for BIB group), Week 39 (9 months) and Week 52 (12 months) were compared to the control group's mean scores at the same timepoints.|Baseline, Week 26, Week 39, Week 52|Randomized participants in the ITT population that provided data at each timepoint. n = number of participants (number of participants varied as not all participants provided data on questionnaire at both timepoints).||units on a scale||Standard Deviation|Mean
773258|NCT00730327|Secondary|Change in Quality of Life (SF-36)|The change in quality of life from baseline to 9 months was measured by the Short Form 36 (SF-36) questionnaire. The SF-36 health survey consists of 36 questions that evaluate 8 discrete domains: Physical Functioning (Physical Func), Social Functioning (Social Func), Bodily Pain, General Health Perceptions (General Health), Vitality, Role limitations due to emotional problems (Role-Emotional), Role limitations due to physical health (Role Physical), and Mental Health. The score for each domain ranges from 0 (poorest health status) to 100 (best health status). The BIB group's mean scores for each SF-36 domain at baseline and week 39 were compared to the control group's mean scores.|Baseline, Week 39|Randomized participants in the ITT population that provided data at each timepoint. n = number of participants (number of participants varied as not all participants provided data on all questionnaire items at both timepoints).||units on a scale||Standard Deviation|Mean
773259|NCT00730327|Secondary|Percent of Participants With Comorbid Conditions|"The percent of participants with a comorbid condition (type 2 diabetes, hypertension, or dyslipidemia) at Week 26 (6 months, balloon removal for BIB group), Week 39 (9 months), and Week 52 (12 months) as compared to baseline.
Comorbid conditions were measured and diagnosed by lab tests and vital signs. Type 2 Diabetes was diagnosed if participants' had a Fasting Plasma Glucose (FPG) ≥126 mg/dL, or symptoms of diabetes plus casual plasma glucose concentration ≥200 mg/dL.
Hypertension was diagnosed if participants' blood pressure measured ≥140 mmHg systolic or ≥90 mmHg diastolic.
Dyslipidemia was diagnosed if participants' labs measured: LDL ≥160 mg/dL, Total Cholesterol ≥240 mg/dL, Serum Triglycerides ≥200 mg/DL, HDL <50 mg/dL (male) or <40 mg/dL (female)."|Baseline, Week 26, Week 39, Week 52|Randomized participants in the ITT population that provided data at that timepoint. n=number of participants who provided lab data at that visit (number of participants varied as not all participants provided all lab data at each visit).||percentage of participants|||Number
773260|NCT00730327|Primary|Percentage of BIB Treated Participants With Significantly Greater Weight Loss Than the Control Group|"The second co-primary effectiveness measure was the percentage of BIB treated participants with significantly greater weight loss than the control group at 9 months. Significantly greater weight loss was defined as ≥ 15% EWL over the mean %EWL of the control group.
%EWL= (weight loss divided by excess weight) * 100, where Weight loss = Baseline weight - selected follow-up weight and Excess weight = Baseline weight - ideal weight.
Ideal weight was determined by using the 1983 Metropolitan Life Height and Weight Table."|9 months|Randomized participants in the ITT population who completed the 39 week (9 month) follow-up visit (with last observation carried forward).||percentage of BIB participants||95% Confidence Interval|Number
773261|NCT00730327|Primary|Mean Percent Excess Weight Loss (%EWL)|"The first co-primary effectiveness measure, was mean percent excess weight loss (% EWL) at 9 months (3 months after the balloon was removed for the BIB group). Percent EWL was calculated using the 1983 Met Life tables for determination of ideal body weight, per the protocol-defined primary effectiveness endpoint.
Percent EWL was calculated as %EWL= (weight loss divided by excess weight)*100, where Weight loss = Baseline weight - selected follow-up weight, and Excess weight = Baseline weight - ideal weight."|9 months|Randomized participants in the intent-to-treat (ITT) population who completed the 39 week (month 9) follow-up visit (with last observed carried forward).||percentage of EWL||Standard Deviation|Mean
773262|NCT00730353|Secondary|Toxicity Profile|Determine the most frequent toxicities associated with the treatment regimen, per the CTCAE version 3 (Common Toxicity Criteria for Adverse Events) criteria.|16 months|||instances of adverse event|||Number
773267|NCT00730483|Secondary|Symptomatic Response by Assessing Symptom Severity in Patients|"Symptomatic response not assessed due to premature termination of study.
Scoring system for assessing symptom severity in patients with neuroendocrine/carcinoid syndrome was as follows:
- No symptoms - Patient completely asymptomatic
- Mild symptoms - Patient with symptoms of diarrhea, flushing, or asthma up to 4 times weekly
- Symptoms impact daily living - symptoms of diarrhea, flushing, or asthma up 5-7 weekly
- Severe symptoms - multiple daily symptoms of diarrhea, flushing, or asthma; symptoms require significant reorganization of daily activities
- Disabling symptoms - Patient disabled by multiple attacks and severe symptoms; unable to leave home or requires hospitalization"|Duration of study participation, average of 12 months||||||
773268|NCT00730483|Secondary|Biochemical Response - Time to Progression|Biochemical response not assessed due to premature termination of study.|Time to progression, 12 months||||||
773269|NCT00730483|Secondary|Survival|Survival outcomes not assessed due to premature termination of study.|overall survival||||||
773270|NCT00730483|Secondary|Tumor Response (Efficacy) - by Response Evaluation Criteria in Solid Tumors (RECIST) and the European Association for the Study of the Liver (EASL) Criteria|"Study was terminated and full outcome not assessed. The results below are based on 13 patients at 1 month post DEB-TACE, 10 patients at 6 months, and 6 patients at 12 months.
RECIST:
Complete Response (CR): Disappearance of all targeted lesions Partial Response (PR): At least 30% decrease in the sum of longest diameter (LD) of targeted lesions Progressive Disease (PD): At least 20% increase in the sum of LD of targeted lesions Stable Disease (SD): Cases that are not applicable for PD or PR.
EASL:
CR: Absence of any enhancement in target lesion PR: Greater than 50% decrease from baseline enhancement in target lesion PD: Greater than 25% increase in target lesion SD: All other cases"|12 months|13 patients were analyzed for 1 month post-treatment; 10 patients for 6 months post-treatment; and 6 patients at the 12 month post-treatment time point.||Participants|||Count of Participants
773271|NCT00730483|Primary|Safety - Number of CTCAE v3.0 Events 1 Month Post DEB-TACE|Safety was assessed at each DEB-TACE procedure and at every follow-up thereafter according to National Cancer Institute Common Toxicity Criteria (CTCAE) v3.0. The study was prematurely terminated due to high incidence of biloma and liver abscess. Safety data below is based off of 13 patients enrolled on protocol at 1 month post initial treatment.|1 month after initial DEB-TACE treatment|||number of adverse events|||Number
773272|NCT00730639|Secondary|Mean Effective Half-life (T-HALFeff)|Nivolumab in human serum was assayed by PPD® (Richmond, Virginia) using a cross-validated ELISA. Blood samples were assessed at all doses from a subset of participants. The PK parameter of T-HALFeff was measured in hours (h).|1,4,8,24,48 and 96 hours post-dose timepoints on Day 1 of cycle 3|All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles.||hours (h)||Standard Deviation|Mean
773273|NCT00730639|Secondary|Geometric Mean Total Body Clearance of Drug From Serum (CLT)|Nivolumab in human serum was assayed by PPD® (Richmond, Virginia) using a cross-validated ELISA. Blood samples Blood samples were assessed at all doses from a subset of participants. The PK parameter of CLT was measured in milliliters per hour (mL/h).|1,4,8,24,48 and 96 hours post-dose timepoints on Day 1 of cycle 3|All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles.||milliliters per hour (mL/h)||Geometric Coefficient of Variation|Geometric Mean
773274|NCT00730639|Secondary|Geometric Mean Area Under the Curve (AUC[TAU]) in One Dosing Interval Observed Post-Single Dose|Nivolumab in human serum was assayed by PPD® (Richmond, Virginia) using a cross-validated ELISA. Blood samples were assessed at all doses from a subset of participants. The PK parameter of AUC was measured in micrograms*hours per milliliter (μg*h/mL).|1,4,8,24,48 and 96 hours post-dose timepoints on Day 1 of cycles 1 and 3|All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles.||micrograms*hours per milliliter (μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
773275|NCT00730639|Secondary|Median Time of Maximum Serum Concentration (Tmax)|Nivolumab in human serum was assayed by PPD® (Richmond, Virginia) using a cross-validated ELISA. Blood samples were assessed Blood samples were assessed at all doses from a subset of participants. The PK parameter of Tmax was measured in hours (h).|1,4,8,24,48 and 96 hours post-dose timepoints on Day 1 of cycles 1 and 3|All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles.||hours (h)||Full Range|Median
773276|NCT00730639|Primary|Number of Participants With Abnormal Hematology Laboratory Values|Hemoglobin, Lymphocytes, Neutrophils, Platelets and Leukocytes. National Cancer Institute Common Terminology Criteria (CTC) version (v) 3.0 was used to determine Grade (Gr). Abnormal values for Hemoglobin were based on Gr 1: 10.0 - less than (<) lower limit of normal (LLN); Gr 2: 8.0 - < 10.0; Gr 3: 6.5 - < 8.0; Gr 4: < 6.5. Abnormal values for Lymphocytes were based on Gr 1: 0.8 - < 1.5; Gr 2: 0.5 - < 0.8; Gr 3): 0.2 - < 0.5; Gr 4: < 0.2. Abnormal values for Neutrophils were based on Gr 1: 1.5 - < 2.0; Gr 2: 1.0 - < 1.5; Gr 3: 0.5 - < 1.0; Gr 4: < 0.5. Abnormal values for Platelets were based on Gr 1: 75.0 - < lower limits of normal (LLN); Gr 2: 50.0 - < 75.0; Gr 3: 25.0 - < 50.0; Gr 4: < 25.0. Abnormal values for Leukocytes were based on Gr 1: 3.0 - < LLN; Gr 2: 2.0 - < 3.0; Gr 3: 1.0 - < 2.0; Gr4: < 1.0.|Day 1 up to June 2013, approximately 4 years|All participants who received at least 1 dose or any partial dose of nivolumab who underwent the laboratory test.||participants|||Number
773277|NCT00730639|Secondary|Geometric Mean Maximum Serum Concentration (Cmax)|Nivolumab in human serum was assayed by PPD® (Richmond, Virginia) using a cross-validated enzyme-linked immunosorbent assay (ELISA). Blood samples were assessed at all doses from a subset of participants. The pharmacokinetic (PK) parameter of Cmax was measured in micrograms per milliliter (µg/mL).|1,4,8,24,48 and 96 hours post-dose timepoints on Day 1 of cycles 1 and 3|All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles.||micrograms per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
773278|NCT00730639|Secondary|Duration of Tumor Response|Duration of tumor response (DOR) was calculated from the first date of response of complete response (CR) or partial response (PR) to the date of the first progressive disease (PD) or the date of death. Duration of response was censored at the last tumor assessment date if a responder did not have PD or death. Nonresponders were not included in the analysis. Median DOR was estimated by Kaplan-Meier analysis.|Day 1 up to June 2013, approximately 4 years|All participants who received at least 1 dose or any partial dose of nivolumab with a measurable tumor response were analyzed.||months||Full Range|Median
775456|NCT00757003|Secondary|Count of Participants Experiencing at Least One Endoleak Following Procedure|Endoleak is persistent blood flow in the aneurysm sac.|Up to 60 months following procedure|||Participants|||Count of Participants
773279|NCT00730639|Secondary|Objective Response Rate|Tumor response was evaluated by the sponsor based on tumor assessments by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Objective response rate (ORR) was defined as the proportion of participants who's confirmed best overall response (BOR) is either complete (CR) or partial (PR), where the denominator is the number of treated participants in the population of interest. Response was based on tumor measurements. Responders= complete response (CR) or partial response (PR). CR=disappearance of all target and non-target lesions; PR=at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter. 95% Confidence intervals (CIs) were computed using the Clopper Pearson method.|Day 1 up to June 2013, approximately 4 years|All participants who received at least 1 dose or any partial dose of nivolumab with an evaluable tumor response were analyzed.||percentage of participants||95% Confidence Interval|Number
773280|NCT00730639|Secondary|Immunogenicity Assessment|Classification of participants host immune response was based on the following definitions: Anti-Drug Antibody (ADA) Positive Subjects have with at least one ADA positive sample at any time after initiation of treatment. ADA positive subjects were further classified into categories with Persistent Positive defined as an ADA positive sample at 2 or more sequential timepoints at least 8 weeks apart.|Day 1 up to June 2013, approximately 4 years|All participants who received at least 1 dose or any partial dose of nivolumab and were ADA-evaluable were analyzed.||participants|||Number
773281|NCT00730639|Primary|Number of Participants With Abnormal Serum Chemistry Laboratory Values|Alkaline phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatinine and Total Bilirubin. National Cancer Institute Common Terminology Criteria (CTC) version (v) 3.0 was used to determine Grade (Gr). Abnormal values for ALP, ALT and AST were based on grades; Gr 1: > 1.0 - 2.5 * upper limits of normal (ULN); Gr 2: > 2.5 - 5.0 * ULN; Gr 3: > 5.0 - 20.0 * ULN; Gr 4: > 20.0 * ULN. Abnormal values for Creatinine were based on Gr 1: > 1.0 - 1.5*ULN; Gr 2: > 1.5 - 3.0*ULN; Gr 3: > 3.0 - 6.0*ULN; Gr 4: > 6.0*ULN. Abnormal values for Total Bilirubin were based on Gr 1: > 1.0 - 1.5 * upper limits of normal (ULN); Gr 2: > 1.5 - 3.0 * ULN; Gr 3: > 3.0 - 10.0 * ULN; Gr 4: > 10.0 * ULN.|Day 1 up to June 2013, approximately 4 years|All participants who received at least 1 dose or any partial dose of nivolumab who underwent the laboratory test.||participants|||Number
773282|NCT00730639|Primary|Number of Participants With Severe Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs|"AE=any new unfavorable symptom, sign or disease or worsening of a preexisting condition that may not have a causal relationship with treatment.
SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity or drug dependency/abuse; is life-threatening, an important medical event or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible or missing relationship to study drug. Death=during the study and up to 28 days past study discontinuation. The select AEs were determined using the Medical Dictionary for Regulatory Activities (MedDRA, v15.1) and graded using the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0."|Day 1 to 70 days following last dose of study drug up to June 2013, approximately 4 years|All participants who received at least 1 dose or any partial dose of nivolumab were analyzed.||participants|||Number
773283|NCT00730691|Secondary|Health Care Resource Utilization Assessed by the Health Economic Assessment Questionnaire|Healthcare resource utilization was assessed by the Health Economic Assessment (HEA) questionnaire, which monitors the participants absenteeism from work, as well as resource use such as visits to a general practitioner, outpatient and inpatient services, hospitalization, medications, and other relevant services over the past 8 weeks.|Baseline and Week 8|Full analysis set||participants|||Number
773284|NCT00730691|Secondary|Change From Baseline in Hospital Anxiety and Depression (HAD) - Depression Subscale at All Weeks Assessed|The HAD-Depression subscale is completed by the participant and measures depression, focusing on the state of lost interest and diminished pleasure response. The subscale is made up of 7 items that are assessed on a scale from 0 (no depression) to 3 (severe feeling of depression). Participants are required to indicate the response which most accurately reflects the way they have felt over the last few days. The item scores are summed and the total subscore ranges from 0 to 21 (maximal severity). LS means were from a mixed model for repeated measurements (MMRM) model with week, Baseline score-by-week and treatment-by-week interaction as factors.|Baseline to Weeks 1, 4 and 8|"Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
773285|NCT00730691|Secondary|Change From Baseline in Clinical Global Impression Scale-Severity of Illness (CGI-S)|The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.|Baseline to Weeks 1, 2, 4, 6 and 8|"Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
773286|NCT00730691|Secondary|Percentage of Participants in HAM-A Remission at Each Week Assessed|Remission is defined as a Hamilton Anxiety Scale (HAM-A) total score ≤ 7. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity).|Weeks 1, 2, 4, 6 and 8|"Full analysis set. LOCF was used. n indicates the number of patients included in the analysis at each time point."||percentage of participants|||Number
773336|NCT00736385|Secondary|Measure the Differential Effects of IR and Lipid Metabolism on Peripheral Mononuclear Cell (PBMC) Inflammatory Response and the Associated Hepatocyte Mitochondrial Ultrastructure and Measures of Oxidative Stress||24 months|Study was terminated early due to difficulties with enrollment. No outcome measures were assessed.|||||
773287|NCT00730691|Secondary|Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed in Participants With Baseline HAM-A ≥25|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.|Baseline to weeks 1, 2, 4 and 6|"Full analysis set patients with a HAM-A Baseline score ≥25. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
773288|NCT00730691|Secondary|Percentage of Responders in HAM-A Total Score at Other Weeks Assessed|Response was defined as participants with a ≥50% decrease from Baseline in the HAM-A total score. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity).|Baseline and Weeks 1, 2, 4 and 6|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."||percentage of participants|||Number
773289|NCT00730691|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) at Other Weeks Assessed|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.|Baseline to Weeks 1, 2 and 4|"Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
773290|NCT00730691|Secondary|Mean Clinical Global Impression Scale-Global Improvement (CGI-I) at Other Weeks Assessed|The Clinical Global Impression - Global Improvement scale measures the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.|Baseline to Weeks 1, 2, 4 and 6|"Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
773291|NCT00730691|Secondary|Change From Baseline in Hospital Anxiety and Depression (HAD) - Anxiety Subscale at Other Weeks Assessed|The HAD-Anxiety subscale is completed by the participant and measures anxiety, including anxious mood, restlessness, anxious thoughts, and panic attacks. The subscale is made up of 7 items that are assessed on a scale from 0 (no anxiety) to 3 (severe feeling of anxiety). Participants are required to indicate the response which most accurately reflects the way they have felt over the last few days. Scores are summed and range from 0 to 21 (maximal severity). LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.|Baseline to Weeks 1 and 4|"Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
773292|NCT00730691|Secondary|Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.|Baseline to Weeks 1, 2, 4 and 6|"Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
773293|NCT00730691|Secondary|Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8 in Participants With Baseline HAM-A ≥25|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.|Baseline to Week 8|Full analysis set patients with a HAM-A Baseline score ≥25. A mixed model for repeated measurements (MMRM) based on observed cases was used.||scores on a scale||Standard Error|Least Squares Mean
773294|NCT00730691|Secondary|Percentage of Responders in HAM-A Total Score at Week 8|Response was defined as participants with a ≥50% decrease from Baseline in the HAM-A total score. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity).|Week 8|Full analysis set; Last observation carried forward (LOCF) was used.||percentage of participants|||Number
773295|NCT00730691|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) at Week 8|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.|Baseline to Week 8|Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.||scores on a scale||Standard Error|Least Squares Mean
773296|NCT00730691|Secondary|Mean Clinical Global Impression Scale-Global Improvement (CGI-I) at Week 8|The Clinical Global Impression - Global Improvement scale measures the participant's improvement (or worsening) as assessed by the investigator relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.|Baseline to Week 8|Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.||scores on a scale||Standard Error|Least Squares Mean
773297|NCT00730691|Secondary|Change From Baseline in Hospital Anxiety and Depression (HAD) - Anxiety Subscale at Week 8|The HAD-Anxiety subscale is completed by the participant and measures anxiety, including anxious mood, restlessness, anxious thoughts, and panic attacks. The subscale is made up of 7 items that are assessed on a scale from 0 (no anxiety) to 3 (severe feeling of anxiety). Participants are required to indicate the response which most accurately reflects the way they have felt over the last few days. Scores are summed and range from 0 to 21 (maximal severity). LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.|Baseline to Week 8|Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.||scores on a scale||Standard Error|Least Squares Mean
773298|NCT00730691|Primary|Change From Baseline in the Hamilton Anxiety (HAM-A) Scale Total Score at Week 8|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Least Squares (LS) means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.|Baseline to Week 8|The full analysis set (FAS) included all randomized patients who received at least 1 dose of study drug, and had at least 1 postbaseline value for assessment of primary efficacy. A mixed model for repeated measurements (MMRM) based on observed cases was used.||scores on a scale||Standard Error|Least Squares Mean
773299|NCT00736190|Secondary|Summary of Resistance Surveillance for Participants Who Discontinued the Study Early|Serum was collected for HBV resistance surveillance, and sequence analysis of the HBV polymerase was assessed through di-deoxy sequencing of baseline and postbaseline samples.|Week 48|2 participants received >= 1 dose of study drug, discontinued TDF treatment after Week 24 with HBV DNA >= 400 copies/mL, and had serum sample for testing.||Participants|||Number
773300|NCT00736190|Secondary|Summary of Resistance Surveillance for Participants With Virologic Breakthrough|Serum was collected for HBV resistance surveillance, and sequence analysis of the HBV polymerase was assessed through di-deoxy sequencing of baseline and postbaseline samples.|Week 48|2 participants received >= 1 dose of study drug, remained viremic (HBV DNA >= 400 copies/mL) after 48 weeks of TDF treatment, had serum sample for testing, and had virologic breakthrough (defined as HBV DNA >= 400 copies/mL [confirmed] after having HBV DNA levels < 400 copies/mL and/or 1-log10 increase [confirmed] in HBV DNA above nadir).||Participants|||Number
773301|NCT00736190|Secondary|Summary of Resistance Surveillance for Participants Without Virologic Breakthrough|Serum was collected for HBV resistance surveillance, and sequence analysis of the HBV polymerase was assessed through di-deoxy sequencing of baseline and postbaseline samples.|Week 48|10 participants received >= 1 dose of study drug, remained viremic (HBV DNA >= 400 copies/mL) after 48 weeks of TDF treatment, had serum sample for testing, and did not have virologic breakthrough (defined as HBV DNA >= 400 copies/mL [confirmed] after having HBV DNA levels < 400 copies/mL and/or 1-log10 increase [confirmed] in HBV DNA above nadir).||Participants|||Number
773302|NCT00736190|Secondary|Number of Participants With Composite Endpoint of HBV DNA <400 Copies/mL (<69 IU/mL), Normal ALT, and Seroconversion to Anti-HBe|Composite endpoints proposed in the protocol included the percentage of participants with HBV DNA < 400 copies/mL (<69 IU/mL) and normal ALT (ALT <= ULN); and with HBV DNA < 400 copies/mL, normal ALT, and HBeAg loss/seroconversion. Because so few participants lost HBeAg or seroconverted to anti-HBe, only the composite endpoint of HBV DNA < 400 copies/mL and normal ALT was analyzed.|Week 48||01/2099||||
773303|NCT00736190|Secondary|Number of Participants With Composite Endpoint of HBV DNA <400 Copies/mL (<69 IU/mL), Normal ALT, and HBeAg Loss|Composite endpoints proposed in the protocol included the percentage of participants with HBV DNA < 400 copies/mL (<69 IU/mL) and normal ALT (ALT <= ULN [34 U/L]); and with HBV DNA < 400 copies/mL, normal ALT, and HBeAg loss/seroconversion. Because so few participants lost HBeAg or seroconverted to anti-HBe, only the composite endpoint of HBV DNA < 400 copies/mL and normal ALT was analyzed.|Week 48||01/2099||||
773304|NCT00736190|Secondary|Number of Participants With HBV DNA < 169 Copies/mL (<29 IU/mL) at Week 48|Blood samples from study participants were collected for measuring HBV DNA via PCR method.|Week 48|The enrolled-and-treated analysis set included participants who were enrolled into the study and received at least one dose of study drug.||Participants|||Number
773305|NCT00736190|Secondary|Number of Participants With HBeAg/Hepatitis B Surface Antigen (HBsAg) Loss and Seroconversion|HBeAg/HBsAg loss is defined for an individual participant as HBeAg+/HBsAg+ at baseline and HBeAg-/HBsAg- at Week 48. HBeAg/HBsAg serocoversion is defined for an individual participant as HBeAg+/HBsAg+ at baseline and HBeAg-/HBsAg- and anti-HBe+/antibody to hepatitis B surface antigen+ (anti-HBs+) at Week 48.|Week 48|||Participants|||Number
773337|NCT00736385|Secondary|Determine if Metformin Improves the Altered Parameters of Lipid Metabolism as Compared to Placebo.||24 months|Study was terminated early due to difficulties with enrollment. No outcome measures were assessed.|||||
773306|NCT00736190|Secondary|Change From Baseline in FibroTest Value|The FibroTest score is used to assess liver fibrosis and is calculated based on a formula including the participant’s age and sex and 5 laboratory parameters: alpha 2 macroglobulin, haptoglobin, gamma-glutamyl transferase (GGT), bilirubin, and apolipoprotein A1. Scores can range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis.|Baseline and Week 48|The enrolled-and-treated analysis set included participants who were enrolled into the study and received at least one dose of study drug.||Scores on a scale||Standard Deviation|Mean
773307|NCT00736190|Secondary|Number of Participants With Composite Endpoint of Hepatitis B Virus (HBV) DNA <400 Copies/mL (<69 IU/mL) and Normal ALT at Week 48|Blood samples were collected for evaluating serum chemistry, including determination of ALT, and for measuring HBV DNA via PCR method. Composite endpoints proposed in the protocol included the percentage of participants with HBV DNA < 400 copies/mL (<69 IU/mL) and normal ALT (ALT <= ULN [34 U/L]); and with HBV DNA < 400 copies/mL, normal ALT, and HBeAg loss/seroconversion. Because so few participants lost hepatitis B e antigen (HBeAg) or developed antibody to hepatitis B e antigen (anti-HBe), only the composite endpoint of HBV DNA < 400 copies/mL and normal ALT was analyzed.|Week 48|The enrolled-and-treated analysis set included participants who were enrolled into the study and received at least one dose of study drug.||Participants|||Number
773308|NCT00736190|Secondary|Number of Participants With ALT Normalized (Baseline Values > ULN [34 U/L] and <= ULN at a Subsequent Visit) at Week 48|A normal value at Week 48 after having elevated ALT at baseline; normal ALT is defined as being at or below the ULN for the central laboratory (34 U/L)|Week 48|The enrolled-and-treated analysis set included participants who were enrolled into the study, received at least one dose of study drug, and had baseline ALT > ULN (34 U/L).||participants|||Number
773309|NCT00736190|Secondary|Number of Participants With Alanine Aminotransferase (ALT) Normal at Week 48|Number of participants with normal ALT (at or below the upper limit of normal [ULN] for the central laboratory [34 U/L])at Week 48|Week 48|The enrolled-and-treated analysis set included participants who were enrolled into the study and received at least one dose of study drug.||Participants|||Number
773310|NCT00736190|Primary|Number of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <400 Copies/mL (<69 IU/mL)|Blood samples were collected from study participants for measuring HBV DNA via polymerase chain reaction (PCR) method.|Week 48|The enrolled-and-treated analysis set included participants who were enrolled into the study and received at least one dose of study drug.||Participants|||Number
773311|NCT00736229|Secondary|Serious Adverse Events (Death, Non-fatal Myocardial Infarction, and Non-fatal Stroke Through 30 Days)||30 days|||participants|||Number
773312|NCT00736229|Secondary|Rates of Hypoglycemia and Severe Hypoglycemia|Total number of patients having at least one hypoglycemic episode (blood glucose less than 70 mg/dl), including episodes classified as severe (blood glucose less than 50 mg/dl)|1-48 hours|||participants|||Number
773313|NCT00736229|Primary|Time to Steady State|Time to steady state was defined as the time from the initiation of drug infusion (Exenatide or Insulin) to first glucose value that is ≤140 mg/dl.|Start of infusion through 48 hours or until discharge|||hours||Inter-Quartile Range|Median
773314|NCT00736229|Primary|Median Glucose Values From Steady State Through 48 Hours or Until Discharge.|Time to steady state was defined as the time from the initiation of drug infusion to first glucose value that is ≤140 mg/dl. Median glucose values were then calculated for each patient from the start of steady state through 48 hours or until discharge.|1-48 hours|Intention to treat||mg/dL||Inter-Quartile Range|Median
773315|NCT00736242|Secondary|Number of Participants With A Serious Adverse Event (SAE) During PEG-IFN Alfa-2b/RBV Treatment|"An SAE was any adverse drug/biologic/device experience occurring at any dose that resulted in death, was life-threatening (i.e. placed the participant, in the view of the initial reporter, at immediate risk of death from the AE as it occurred), was a persistent or significant disability/incapacity, required in-patient hospitalization, or prolonged hospitalization, or led to a
congenital anomaly or birth defect."|From First Participant Visit (12/30/2005) up to 30 days after Last Participant Visit (12/31/2011).|Safety Analysis Set: All participants who received any amount of PEG-IFN alfa-2b. If the application of any PEG-IFN alfa-2b was not certain, the participant was considered part of this set. Participants who were not treated with PEG-IFN alfa-2b were also included in this set providing they did not violate any inclusion or exclusion criterion.||participants|||Number
773316|NCT00736242|Secondary|Median Cluster of Differentiation 4 (CD4) Cell Count During PEG-IFN Alfa-2b/RBV Treatment|The CD4 helper T cell count was used to assess participant HIV status and was determined in the laboratory at baseline and during the study course.|From the Baseline Visit up to EOF (up to 72 weeks)|Analysis was performed on all participants in the Efficacy Analysis Set (all participants with HCV-RNA detectable for at least 6 months before the first application of PEG-IFN alfa-2b, HIV co-infection, and who had received any amount of PEG-IFN alfa-2b) with data available.||cells/μL||Full Range|Median
773317|NCT00736242|Secondary|Number of Participants With Human Immunodeficiency Virus (HIV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment|"HIV-RNA negativity/positivity was documented at baseline in the medical history (anamnesis), and assessed within the laboratory (lab) at baseline and during treatment.
HIV-RNA (+) = HIV-RNA positive, HIV-RNA (-) = HIV-RNA negative, HIV-RNA Missing = HIV-RNA data not documented, not applicable, not known, not examined, or missing"|From the Baseline Visit up to EOF (up to 72 weeks)|Efficacy Analysis Set: all participants with HCV-RNA detectable for at least 6 months before the first application of PEG-IFN alfa-2b, HIV co-infection, and who had received any amount of PEG-IFN alfa-2b.||participants|||Number
773318|NCT00736242|Secondary|Number of Participants With Hepatitis C Virus (HCV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment|"HCV-RNA negativity/positivity was documented at baseline in the medical history (anamnesis), and assessed within the laboratory (lab) at baseline and during treatment by Polymerase Chain Reaction (PCR).
HCV-RNA (+) = HCV-RNA positive, HCV-RNA (-) = HCV-RNA negative, HCV-RNA Missing = HCV-RNA data not documented, not applicable, not known, not examined, or missing."|From the Baseline Visit up to EOF (up to 72 weeks)|Efficacy Analysis Set: all participants with HCV-RNA detectable for at least 6 months before the first application of PEG-IFN alfa-2b, HIV co-infection, and who had received any amount of PEG-IFN alfa-2b.||participants|||Number
773338|NCT00736385|Secondary|Tests the Postulate That Metformin Will Improve Insulin Sensitivity in NAFLD. Also Test the Postulate That Improving IR (Insulin Resistance) With an Insulin Sensitizing Agent Will Improve Biochemical and Histological Features of NAFLD.||24 months|Study was terminated early due to difficulties with enrollment. No outcome measures were assessed.|||||
773319|NCT00736242|Secondary|Participant Study Status at End of Follow-up (EOF)|"Participant study status was assessed at the End of Follow-up (defined as 24 weeks after the end of treatment) based on serum levels of HCV-RNA.
SVR was defined as defined as undetectable serum HCV-RNA at EOT and EOF, Relapse was defined as undetectable HCV-RNA at EOT with detectable HCV-RNA at EOF, and Non-response was defined as a detectable serum HCV-RNA at EOT."|From EOT to EOF (up to 72 weeks)|Analysis was performed on all participants in the Efficacy Analysis Set (all participants with HCV-RNA detectable for at least 6 months before the first application of PEG-IFN alfa-2b, with HIV co-infection, and who had received any amount of PEG-IFN alfa-2b) with documented visits at EOT or at follow-up 24 weeks after EOT.||participants|||Number
773320|NCT00736242|Secondary|Number of Participants With Early Virologic Response (EVR)|"EVR was defined as undetectable serum HCV-RNA at week 12 and/or a
≥2 log decline in HCV-RNA levels at week 12 from baseline."|From Treatment Week 1 to Treatment Week 12|Analysis was performed on all participants in the Efficacy Analysis Set (all participants with HCV-RNA detectable for at least 6 months before the first application of PEG-IFN alfa-2b, HIV co-infection, and who had received any amount of PEG-IFN alfa-2b) with a documented visit at Treatment Week 12.||participants|||Number
773321|NCT00736242|Secondary|Number of Participants With Rapid Virologic Response (RVR)|RVR was defined as undetectable serum HCV-RNA at week 4.|At Treatment Week 4|Analysis was performed on all participants in the Efficacy Analysis Set (all participants with HCV-RNA detectable for at least 6 months before the first application of PEG-IFN alfa-2b, HIV co-infection, and who had received any amount of PEG-IFN alfa-2b) with a documented visit at Treatment Week 4||participants|||Number
773322|NCT00736242|Primary|Number of Participants With Sustained Virologic Response (SVR)|SVR was defined as undetectable serum Hepatitis C Virus ribonucleic acid (HCV-RNA) at End of Treatment (EOT) and at the End of Follow-up (EOF).|From End of Treatment to 24 weeks post-treatment (up to 72 weeks)|Analysis was performed on all participants in the Efficacy Analysis Set (all participants with HCV-RNA detectable for ≥6 months before the first application of PEG-IFN alfa-2b, Human Immunodeficiency Virus [HIV] co-infection, and who had received any amount of PEG-IFN alfa-2b) with documented visits at EOT or at follow-up 24 weeks after EOT.||participants|||Number
773323|NCT00736255|Secondary|Clinician Rated Clinical Global Impressions of Improvement Scale (CGI-I)|Measures clinician's perception of patient improvement at the time of assessment compared with the start of treatment.|Visits 2, 4, 6, & 8||||||
773324|NCT00736255|Secondary|Cognitive Functioning|This is measured by Continuous Performance Test (CPT) and N-Back|Randomization, visit 1, 2, 3, 4, 5, 6, 7, 8||||||
773325|NCT00736255|Secondary|ADHD CAARS Self-Report and Observer Short Forms|T-scores derived from compiled ADHD symptoms from two forms.|Randomization, visit 2, 4, 6, 8||||||
773326|NCT00736255|Secondary|Continuous Performance Test (CPT) Reaction Time Standard Error|The CPT is a measure of both vigilance/sustained attention and response inhibition, has good normative data and has been shown to be sensitive to the effects of stimulants. Reaction time variability and commission errors – measures of attentional control and response inhibition have been shown to be sensitive in discriminating individuals with ADHD on active medication versus placebo.|Randomization, visit 1, 2, 3, 4, 5, 6, 7, 8|||Reaction time in seconds||Standard Deviation|Mean
773327|NCT00736255|Secondary|Continuous Performance Test (CPT) Commission Errors|The CPT is a measure of both vigilance/sustained attention and response inhibition, has good normative data and has been shown to be sensitive to the effects of stimulants. Reaction time variability and commission errors – measures of attentional control and response inhibition have been shown to be sensitive in discriminating individuals with ADHD on active medication versus placebo.|Randomization, visit 1, 2, 3, 4, 5, 6, 7, 8|||Errors of Commission||Standard Deviation|Mean
773328|NCT00736255|Secondary|Smoking Rates|Smoking rates, measured as self-reported cigarettes/day.|Randomization, visit 1, 2, 3, 4, 5, 6, 7, 8||||||
773329|NCT00736255|Primary|The Number of Subjects in Each Treatment Group Exhibiting Sustained, 4-week Smoking Abstinence, Defined as CO Levels < 4 Ppm for Each Post-quit Study Visit.|The primary outcome measure was the proportion of subjects in each treatment group exhibiting sustained, 4-week smoking abstinence, defined as CO levels < 4 ppm for each post-quit study visit. Subjects who dropped from the study for any reason were considered to have lapsed.|4 weeks|Subjects exhibiting sustained 4 week smoking abstinence defined as CO levels <4ppm for each post quit study visit were analyzed for the outcome measure.||participants|||Number
773330|NCT00736333|Primary|Number of Times Premedications Were Given for Prevention of PPE|Pre-medications given included oral dexamethasone, vitamin B6, and other not clearly defined medications.|Day 1 up to 24 weeks|Safety population (those who received at least one dose of study medication)||Number of times premedication was given|||Number
773331|NCT00736333|Primary|Number of Occurrences of Palmar-plantar Erythrodysesthesia (PPE)|PPE was defined as a dermatological adverse event characterized by swelling, pain, edema, erythema, desquamation, that may have ultimately resulted in fissuring and ulceration, involving fingers, toes, palms, plantar aspects of the feet, and other pressure-sensitive areas of the skin.|Up to 24 weeks|Safety population (those who received at least one dose of study medication)||Occurrences|||Number
773332|NCT00736333|Primary|Number of Participants With Pre-existing Allergic Conditions Who Experienced an IR|Allergic conditions included food allergies, drug allergies, allergic rhinitis, histamine allergy, neurodermatitis, and chronic idiopathic urticaria.|Cycles 1 & 3 (Week 4 & Week 12)|Safety population (those who received at least one dose of study medication)||Participants|||Number
773333|NCT00736333|Primary|Percent of Participants Taking Premedication for Prevention of IR|Premedications for prevention of IR included corticosteroids, serotonin-3 receptor antagonists (anti-emetics), histamine-1 receptor blockers, and histamine-2 receptor blockers.|Day 1, immediately prior to receiving first dose of pegylated liposomal doxorubicin|Safety population (those who received at least one dose of study medication)||Percent of participants|||Number
773334|NCT00736333|Secondary|Number of Participants With Complete Response (CR) or Partial Response (PR)|CR and PR were documented according to the clinical standards of each site.|Day 1 up to 24 weeks|Intent-to-treat (those who received at least one dose of study medication)||Participants|||Number
773335|NCT00736333|Primary|Number of Participants With Infusion Reactions (IR)|Infusion reaction was defined as an allergic reaction or anaphylactoid reaction characterized by shortness of breath, hypotension, back pain, chest pain, chills, flush, sweating, fever, nausea, dizziness, rash, pruritis, or tachycardia.|Day 1 up to Week 24|Safety population (those who received at least one dose of study medication)||Participants|||Number
773339|NCT00736385|Primary|Study Endpoints Will Include Measurements of Insulin Sensitivity, Hepatic Insulin Clearance, and Altered Parameters of Lipid Metabolism, Changes in the Histological Features That Define NAFLD, and Quantitative Measurements of Visceral and Peripheral Fat.||24 months|Study was terminated early due to difficulties with enrollment. No outcome measures were assessed.|||||
773340|NCT00736476|Secondary|Proliferative Response Against the Pooled H. Pylori Vaccine Antigens by Stimulation Index (SI)|The proliferation of H. pylori-specific Peripheral blood mononuclear cells (PBMCs) following HP antigen stimulation was assessed to measure the magnitude of the cell mediated immune response.|12 weeks post HP challenge|Per-protocol dataset||Stimulation Index (SI)||Standard Deviation|Mean
773341|NCT00736476|Secondary|Response on Activated Regulatory T Cell Subset Following HP Vaccination and HP Challenge|The response to 3 doses of HP vaccine and the oral HP challenge was assessed with respect their ability to induce differentiation and changes in the phenotype of a subset of regulatory T-cells CD4+CD25+Foxp3+ that expresses Treg Markers PD-1 and/or HLA-DR.|12 weeks post HP challenge|Per-protocol dataset||percentage of T-cells||Standard Deviation|Mean
773342|NCT00736476|Secondary|Geometric Mean Concentrations Against Vaccine Antigens After HP Challenge.|The geometric mean concentration of IgG antibody responses to each of the HP vaccine antigens (VacA, CagA and NAP) after HP challenge were compared between vaccinated and placebo groups.|12 months|Per-protocol dataset||μg/mL||95% Confidence Interval|Geometric Mean
773343|NCT00736476|Secondary|The Geometric Mean Concentrations After HP Vaccination.|The geometric mean concentration of IgG antibody responses to each of the HP vaccine antigens (VacA, CagA and NAP)after HP vaccination as compared to placebo are reported.|upto 1 month after 3rd vaccination|Per-Protocol dataset||μg/mL||95% Confidence Interval|Geometric Mean
773344|NCT00736476|Secondary|The Time Course of HP Infection Following HP Challenge in Vaccinated and Placebo Groups|The time course of HP infection following HP challenge in subjects of the HP vaccine and placebo groups, were assessed by non-invasive HP tests.|12 months|||Participants|||Number
773345|NCT00736476|Primary|Number of Subjects Reporting Solicited Local* and Systemic Adverse Events Following Vaccination|To assess the tolerability of an HP vaccine versus placebo in terms of number of subjects reporting solicited local* and systemic adverse events.|Day 1-7 post vaccination|This analysis was done on the safety dataset||Participants|||Number
773346|NCT00736476|Primary|The Efficacy (Defined as Prevention of Infection) of the HP Vaccine Compared to Placebo.|"The efficacy of the investigational vaccine to prevent infection following H.pylori challenge in healthy adults was determined in terms of percentage of subjects with positive HP infections in the vaccinated and unvaccinated groups(Placebo).
Infection rates was assessed by invasive Upper Gastrointestinal Endoscopy (UGE)tests that included HP histopathology, HP culture and rapid urease test (RUT), and non-invasive HP tests which included urea breath test (UBT) and fecal antigen test (FAT)."|12 weeks post HP challenge|Per-protocol dataset||Percentage of subjects|||Number
773347|NCT00736489|Secondary|Plasma AZD3199 AUC0-24|Area under the plasma concentration curve from time 0 to 24 h post-dose|0, 5min, 15min, 30min, 1h, 2h, 4h, 8h, 12h, 24h|Two patients discontinued after the first treatment period and were excluded from pharmacokinetic analysis set.||nmol*h/L||Full Range|Geometric Mean
773348|NCT00736489|Secondary|Plasma AZD3199 Cmax|Maximum plasma concentration of AZD3199 measured|0, 5min, 15min, 30min, 1h, 2h, 4h, 8h, 12h, 24h|Two patients discontinued after the first treatment period and were excluded from pharmacokinetic analysis set.||nmol/L||Full Range|Geometric Mean
773349|NCT00736489|Secondary|Palpitations, Average Effect Over 0 - 4 h Post-dose|Average palpitation score (4 grade scale: 0=no, 1=mild, 2=moderate or 3=severe) over 4 h|0, 15min, 30min, 1h, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. One patient on Placebo, 1 patient on formoterol 36 mcg and 1 patient on AZD3199 480 mcg had no data for subsequent analysis.||Score on a scale||Standard Deviation|Mean
773350|NCT00736489|Secondary|Palpitations, Peak Effect Over 0 - 4 h Post-dose|Maximum palpitation score (4 grade scale: 0=no, 1=mild, 2=moderate or 3=severe) over 4 h|0, 15min, 30min, 1h, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. One patient on Placebo, 1 patient on formoterol 36 mcg and 1 patient on AZD3199 480 mcg had no data for subsequent analysis.||Score on a scale||Standard Deviation|Mean
773351|NCT00736489|Secondary|Tremor, Average Effect Over 0 - 4 h Post-dose|Average tremor score (4 grade scale: 0=no, 1=mild, 2=moderate or 3=severe) over 4 h.|0, 15min, 30min, 1h, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. One patient on Placebo, 1 patient on formoterol 36 mcg and 1 patient on AZD3199 480 mcg had no data for subsequent analysis.||Score on a scale||Standard Deviation|Mean
773352|NCT00736489|Secondary|Tremor, Peak Effect Over 0 - 4 h Post-dose|Maximum tremor score (4 grade scale: 0=no, 1=mild, 2=moderate or 3=severe) over 4 h.|0, 15min, 30min, 1h, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. One patient on Placebo, 1 patient on formoterol 36 mcg and 1 patient on AZD3199 480 mcg had no data for subsequent analysis.||Score on a scale||Standard Deviation|Mean
773353|NCT00736489|Secondary|QTcB, Average Effect Over 0 - 4 h Post-dose|Average QTc Bazett over 4 h|0, 30min, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences.||ms||Standard Deviation|Mean
773354|NCT00736489|Secondary|QTcB, Peak Effect Over 0 - 4 h Post-dose|Maximum QTc Bazett over 4 h|0, 30min, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences.||ms||Standard Deviation|Mean
773355|NCT00736489|Secondary|Heart Rate, Average Effect Over 0 - 4 h Post-dose|Average heart rate over 4 h|0, 30min, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences.||bpm||Standard Deviation|Mean
773356|NCT00736489|Secondary|Heart Rate, Peak Effect Over 0 - 4 h Post-dose|Maximum heart rate over 4 h|0, 30min, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences.||bpm||Standard Deviation|Mean
773357|NCT00736489|Secondary|Pulse, Average Effect Over 0 - 4 h Post-dose|Average pulse over 4 h|0, 30min, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences.||bpm||Standard Deviation|Mean
773358|NCT00736489|Secondary|Pulse, Peak Effect Over 0 - 4 h Post-dose|Maximum pulse over 4 h|0, 30min, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences.||bpm||Standard Deviation|Mean
773359|NCT00736489|Secondary|Diastolic Blood Pressure, Average Effect Over 0 - 4 h Post-dose|Average DBP value over 4 h|0, 30min, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences.||mmHg||Standard Deviation|Mean
773360|NCT00736489|Secondary|Diastolic Blood Pressure, Peak Effect Over 0 - 4 h Post-dose|Minimum DBP value over 4 h|0, 30min, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences.||mmHg||Standard Deviation|Mean
773361|NCT00736489|Secondary|Systolic Blood Pressure, Average Effect Over 0 - 4 h Post-dose|Average SBP value over 4 h|0, 30min, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences.||mmHg||Standard Deviation|Mean
773362|NCT00736489|Secondary|Systolic Blood Pressure, Peak Effect Over 0 - 4 h Post-dose|Maximum SBP value over 4 h|0, 30min, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences.||mmHg||Standard Deviation|Mean
773363|NCT00736489|Secondary|FEV1 Average Effect Over 12 - 24 h Post-dose|FEV1 average effect over 12 h night-time period|12h, 14h, 18h, 22h, 24h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. One patient on Placebo treatment had data not sufficient for computing PD parameters and for subsequent analysis.||L||Standard Deviation|Mean
773364|NCT00736489|Secondary|FEV1 Average Effect Over 0 - 12 h Post-dose|FEV1 average effect over 12 h day-time period|0, 5min, 15min, 30min, 1h, 2h, 4h, 6h, 8h, 10h, 12h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. One patient on Placebo treatment had data not sufficient for computing PD parameters and for subsequent analysis.||L||Standard Deviation|Mean
773365|NCT00736489|Secondary|FEV1 Average Effect Over 0 - 24 h Post-dose|FEV1 average effect over 24 h dosing interval|0, 5min, 15min, 30min, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 22h, 24h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. One patient on Placebo treatment had data not sufficient for computing PD parameters and for subsequent analysis.||L||Standard Deviation|Mean
773366|NCT00736489|Secondary|FEV1 Effect at 5 Min Post-dose|FEV1 at 5 minutes|5min|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. Two patients on Placebo and 1 on AZD3199 480 mcg had data not sufficient for computing PD parameters and for subsequent analysis.||L||Standard Deviation|Mean
773367|NCT00736489|Primary|S-potassium, Average Effect Over 0 - 4 h Post-dose|Average S-potassium concentration|0, 15min, 30min,1h, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. Two patients on AZD3199 1920 mcg had data not sufficient for computing PD parameters and for subsequent analysis.||mmol/L||Standard Deviation|Mean
773368|NCT00736489|Primary|S-potassium, Peak Effect Over 0 - 4 h Post-dose|Minimum S-potassium concentration (A well-known effect of beta2-agonists (AZD3199 is a beta2-agonist) is a reduction in serum potassium levels. The minimum value has therefore been evaluated.|0, 15min, 30min,1h, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. Two patients on AZD3199 1920 mcg had data not sufficient for computing PD parameters and for subsequent analysis.||mmol/L||Standard Deviation|Mean
773369|NCT00736489|Primary|E22-26: the Average of the FEV1 Value Between 22 and 26 h Post Dose for Every Treatment Visit.|Residual FEV1 24 h post-dose|22- 26 h post dose|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. One patient on Placebo treatment had data not sufficient for computing PD parameters and for subsequent analysis.||L||Standard Deviation|Mean
773370|NCT00736489|Primary|FEV1 Peak Effect Within 0 - 24 h Post-dose|Maximum FEV1 value|0, 5min, 15min, 30min, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 22h, 24h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. One patient on Placebo treatment had data not sufficient for computing PD parameters and for subsequent analysis.||L||Standard Deviation|Mean
773371|NCT00736502|Secondary|Change in CD4+ Cell Count From Baseline to Week 48|Calculated as CD4+ cell count at week 48 minus the baseline value|Baseline and week 48|TS with non-missing data at baseline and week 48||Cells/mm^3||Standard Deviation|Mean
773372|NCT00736502|Secondary|Virologic Response (VR)|VR was defined as Human immunodeficiency virus (HIV) viral load of <50 copies/mL before week 48 and without any subsequent rebound or change of Antiretroviral (ARV) therapy. A rebound was defined by two consecutive measurements of Viral load (VL) >= 50 copies/mL, at least two weeks apart, after two consecutive measurements of VL < 50 copies/mL. A change of ARV therapy was defined as a permanent discontinuation of Nevirapine.|48 weeks|TS||Participants|||Number
773373|NCT00736502|Primary|Proportion of Patients Reporting Adverse Events|the incidence of non serious adverse events and serious adverse events according to body system (= System Organ Class) and preferred term.|48 weeks|The treated Set (TS), defined as all patients reported to have received at least one dose of Nevirapine.||Percentage of participants|||Number
773374|NCT00738023|Secondary|Changes in Systolic Blood Pressure During Intralipid Infusion Post-rosiglitazone Intervention|Systolic blood pressure change from baseline during an 48-hour intralipid infusion after taking rosiglitazone for 6 weeks in obese diabetic subjects|48 hours|||mmHg||Standard Error|Mean
773379|NCT00738049|Primary|Change During Darusentan Treatment in the Markovian Homogeneity Number, a Value That Quantitates Myocardial Perfusion Heterogeneity|Markovian homogeneity analysis characterizes an image produced by a PET scan by examining the probability that a pixel with a given intensity will have a neighbor with a different intensity. The homogeneity index ranges from >0 to 1, where a value near 0 represents an image with a high probability that neighboring pixels have intensity values that differ greatly, and a value near 1 represents an image with a high probability that neighboring pixels have similar intensity values.|0, 2, 4, and 6 weeks|Statistical analysis is exploratory, therefore not easily planned. A paired t-test with 40 subjects will provide approximately 89% power to test the null hypothesis of no change in the homogeneity number versus a two-sided alternative at alpha= 5%,if the true mean change is 0.15,e.g.,a homogeneity index of 0.5 at baseline and 0.65 after darusentan.||No units||Standard Deviation|Mean
773380|NCT00738062|Secondary|Clinician Rated Clinical Global Impressions - Improvement|"The CGI-I is a 7 point scale ranging from a score of 1 (very much improved) to 7 (very much worse), with no change in the middle, and assesses the improvement in relation to the baseline evaluation.
Patients will be grouped according change in disease as follows;
Very Much Improved to Slightly Improved (CGI-I 1-3),
No Change (CGI-I 4),
Slightly Worse to Very Much Worse (CGI-I 5-7)."|14 days|||participants|||Number
773381|NCT00738062|Secondary|Patient Reported Clinical Global Impression - Improvement|"The CGI-I is a 7 point scale ranging from a score of 1 (very much improved) to 7 (very much worse), with no change in the middle, and assesses the improvement in relation to the baseline evaluation.
Patients will be grouped according change in disease as follows;
Very Much Improved to Slightly Improved (CGI-I 1-3),
No Change (CGI-I 4),
Slightly Worse to Very Much Worse (CGI-I 5-7)."|14 days|||participants|||Number
773382|NCT00738062|Secondary|Clinician Recorded Clinical Global Impression - Severity|"The CGI-S is a 7 point scale ranging from a score of 1 (no symptoms) to 7 (severe symptoms). Patients were grouped according to OH severity at the end of the randomization period as follows;
Normal-Borderline OH (CGI-S 1-2),
Mild-Moderate OH (CGI-S 3-4),
Marked OH-Most Ill with OH (CGI-S 5-7)."|14 days|||participants|||Number
773383|NCT00738062|Secondary|Patient Reported Clinical Global Impression - Severity|"The CGI-S is a 7 point scale ranging from a score of 1 (no symptoms) to 7 (severe symptoms). Patients were grouped according to OH severity at the end of the randomization period as follows;
Normal-Borderline OH (CGI-S 1-2),
Mild-Moderate OH (CGI-S 3-4),
Marked OH-Most Ill with OH (CGI-S 5-7). ."|14 days|||participants|||Number
773384|NCT00738062|Post-Hoc|Change in Dizziness/ Lightheadedness/ Feeling Faint/ or Feeling Like You Might Blackout (OHSA Item 1)|OHSA item 1 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug). All patients were on open-label droxidopa for 3 months prior to randomization to either continued droxidopa or to placebo.|14 days|||units on a scale||Standard Deviation|Mean
773385|NCT00738062|Secondary|Change in Systolic Blood Pressure (SBP) Measurements 3 Minutes Post Standing|Change: standing systolic blood pressure at end of study minus standing systolic blood pressure at randomization. In this withdrawal design, a negative score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug). All patients are on open-label droxidopa for 3 months prior to randomization to either continued droxidopa or to placebo.|14 days|||mmHg||Standard Deviation|Mean
773386|NCT00738062|Secondary|Change in Orthostatic Hypotension Symptom Assessment (OHSA) Composite Score|"The OHSA scale is the average of six items: 1) Dizziness, lightheadedness, feeling faint or feeling like you might black out; 2) Problems with vision; 3) Weakness; 4) Fatigue; 5) Trouble concentrating; and 6) Head/neck discomfort. Each asks the patient to rate their symptoms over the past week. Each item is scored on a Likert scale from 0 to 10, with 10 being the most severe.
Change: score at end of randomization minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug)."|14 days|||units on a scale||Standard Deviation|Mean
773387|NCT00738062|Secondary|Change in Orthostatic Hypotension Daily Activities (OHDAS) Score|"The OHDAS scale is the average of four items: 1) Standing for a short time; 2) Standing for a long time; 3) Walking for a short time; and 4) Walking for a long time. Each asks the patient to rate their disease impact over the past week. Each item is scored on a Likert scale from 0 to 10, with 10 being the most severe.
Change: score at end of randomization minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug)."|14 days|One droxidopa patient excluded from analysis because data were not evaluable.||units on a scale||Standard Deviation|Mean
773388|NCT00738062|Primary|Change in Orthostatic Hypotension Questionnaire Composite Score (OHQ)|"The OHQ is the average of two sub-scales, the Orthostatic Hypotension Symptom Assessment Scale (OHSA) and the Orthostatic Hypotension Daily Activities Scale (OHDAS). Each asks the patient to rate their symptoms or disease impact over the past week. The OHSA sub-scale is the average of six items: 1) Dizziness, lightheadedness, feeling faint or feeling like you might black out; 2) Problems with vision; 3) Weakness; 4) Fatigue; 5) Trouble concentrating; and 6) Head/neck discomfort. The OHDAS sub-scale is the average of four items: 1) Standing for a short time; 2) Standing for a long time; 3) Walking for a short time; and 4) Walking for a long time. Each item is scored on a Likert scale from 0 to 10, with 10 being the most severe.
In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug). All patients are on open-label droxidopa for 3 months prior to randomization."|14 days|"The analysis population was based on the ITT population of all patients randomized. Last observation carry forward was used for patients who prematurely discontinued the study.
One droxidopa patient was excluded from the analysis because OHQ values were not evaluable."||units on a scale||Standard Deviation|Mean
773401|NCT00738374|Secondary|PFS|The median time, in days, from the date of the first dose of study treatment to the date of first documentation of disease progression or death. CR and PD as previously defined. Participants who were withdrawn from the study without documented disease progression were censored at the date of the last tumor assessment when the participant was known to be progression-free. Participants without a post-BL tumor assessment, but known to be alive, were censored at the time of the first dose of study treatment. The 95% CI was determined using Kaplan-Meier methodology.|Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.|ITT population||days||95% Confidence Interval|Median
773389|NCT00738283|Primary|Zinc Absorption|"Zinc fractional absorption was measured using a dual tracer stable isotope method in which 67Zn was given orally with a single feed followed immediately by infusion of 70Zn intravenously. A spot urine sample was collected 96 hours after the infusion and the relative dose-corrected enrichments used to calculate fractional absorption at the time oral isotope was administered.
Tracer:tracee ratios (TTR), measured by ICP-MS, were used to calculated fractional zinc absorption."|96 hours after single feed infusion|Relationships between zinc absorption, zinc excretion (urine or fecal) and zinc balance, and potential explanatory variables were analyzed using the GLM model function of JMP 7 for Macintosh (SAS inc, Cary, NC). Simple and multiple regression analysis were used as appropriate. Significance was assumed at a p < 0.05.||fractional zinc absorption (%)||Standard Deviation|Mean
773390|NCT00738361|Secondary|Overall Survival|Overall Survival is defined as the time from the start of treatment (study day 1) until death to the date of his or her death. If the subject has not died, survival time will be censored on last date the subject was known to be alive.|up to 1 year following last treatment, for a total of approximately 5 years|||months||Standard Error|Mean
773391|NCT00738361|Secondary|Progression-free Survival|Median progression free survival (PFS) in patients with metastatic uveal melanoma who received nab-paclitaxel|up to 1 year following last treatment, for a total of approximately 5 years|all patients progressed at the time of first scan||months||95% Confidence Interval|Median
773392|NCT00738361|Primary|Overall Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|up to 1 year following last treatment, for a total of approximately 5 years|||patients|||Number
773393|NCT00738374|Secondary|Disease-Free Survival|The mean time, in days, from the date of first documented CR or CRi to the date of disease progression or death. CR, CRi, and PD as previously defined. Participants with no documented PD after CR or CRi were censored on the last date at which they were known to have had CR or CRi. In both groups, the mean survival time and its standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time.|Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.|All randomized participants.||days||Standard Error|Mean
773394|NCT00738374|Secondary|Number of Participants With PD or Death After a Confirmed CR/CRi|Disease-free survival was defined at the time from the date of first documented CR or CRi to the date of disease progression or death. CR, CRi, and PD as previously defined. Participants with no documented PD after CR or CRi were censored on the last date at which they were known to have had CR or CRi.|Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.|All randomized participants with a confirmed CR or CRi were included in the analysis.||participants|||Number
773395|NCT00738374|Secondary|Duration of Response|The mean time, in days, from the date of first documented CR, CRi or PR to the date disease progression or death. CR, CRi, PR, and PD as previously defined. Participants with no documented PD after CR, CRi, or PR were censored at the last date at which they were known to have had CR, CRi, or PR, respectively.|Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.|All randomized participants.||days||Standard Error|Mean
773396|NCT00738374|Secondary|Number of Participants With PD or Death After a Confirmed CR, CRi, or PR|Duration of response was defined as the time from the date of the first documented CR, CRi, or PR to the date of disease progression or death. CR, CRi, PR, and PD as previously defined. Participants with no documented PD after CR, CRi, or PR were censored at the last date at which they were known to have had CR, CRi, or PR, respectively.|Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.|All randomized participants.||participants|||Number
773397|NCT00738374|Secondary|OS|The mean time, in days, from the date of the first dose of study treatment to the date of death due to any cause. Participants were censored at the date of the last follow-up assessment. Participants without a follow-up assessment were censored at the day of last dose of study treatment. The mean survival time and it's SE were underestimated because the largest observation was censored and the estimation was restricted to the largest event time.|Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.|ITT population||days||Standard Error|Mean
773398|NCT00738374|Secondary|Number of Participants Who Died|Overall Survival (OS) was defined as the time from the date of the first dose of study treatment to the date of death due to any cause. Participants were censored at the date of the last follow-up assessment. Participants without a follow-up assessment were censored at the day of last dose of study treatment.|Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.|ITT population||participants|||Number
773399|NCT00738374|Secondary|Time to Next Treatment (TTNT)|The mean time, in days, from the date of the first dose of study treatment to the date of new CLL treatment or the date of death from any cause. Participants who did not receive new CLL treatment and were alive at the time of the analysis were censored at the date of the last follow-up assessment. Participants without a follow-up assessment were censored at the day of last dose of study treatment. Mean survival time and it's standard error (SE) were underestimated because the largest observation was censored and the estimation was restricted to the largest event time.|Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.|ITT population||days||Standard Error|Mean
773400|NCT00738374|Secondary|Number of Participants With New CLL Treatment or Death|Time to new CLL treatment (TTNT) was defined as the time from the first dose of study treatment to the date of new CLL treatment received or the date of death from any cause. Participants who did not receive new CLL treatment and were alive at the time of the analysis were censored at the date of the last follow-up assessment. Participants without a follow-up assessment were censored at the day of last dose of study treatment.|Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.|ITT population||participants|||Number
773433|NCT00738543|Primary|Bacterial Colony Forming Units for the Control Period|After incubation, the outcome assessor counted the colonies to determine the colony-forming units per square centimeter (CFU/cm2) of skin.|24 hours|||Colony-forming units per cm squared||Inter-Quartile Range|Median
775457|NCT00757003|Primary|Percentage of Participants With Technically Successful Implant|The percentage of participants with technically successful implantation as assessed by the investigator is reported.|Day 0 to Day 30|||percentage of participants|||Number
773402|NCT00738374|Secondary|Number of Participants With Disease Progression or Death|Progression-free survival (PFS) was defined as the time from the first dose of study treatment to the first documentation of disease progression or death. PD as previously defined. Participants who were withdrawn from the study without documented disease progression were censored at the date of the last tumor assessment when the participant was known to be progression-free. Participants without a post-BL tumor assessment, but known to be alive, were censored at the time of the first dose of study treatment.|Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.|ITT population||participants|||Number
773403|NCT00738374|Secondary|EFS|The median time, in days, from the the date of first dose of study treatment to the date of first documentation of disease progression, relapse for participants with CR, death due to any cause, withdrawal due to AE, or new CLL treatment. CR and PD as previously defined. Participants were censored at the time of data cut-off to the most recent date of disease assessment. Participants without a post-BL disease assessment were censored at the time of first dose if study treatment. The 95% CI was determined using Kaplan-Meier methodology.|Screening, Days 1 and 15 of Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.|ITT population||days||95% Confidence Interval|Median
773404|NCT00738374|Secondary|Number of Participants With Disease Progression, Relapse, Death, Withdrawal Because of an Adverse Event (AE), or New CLL Treatment|Event-free Survival (EFS) was defined as the time from the first dose of study treatment to the date of first documentation of disease progression, relapse for participants with previous CR, death due to any cause, withdrawal due to AE, or beginning new CLL treatment. CR and PD as previously defined. Participants were censored at the time of data cut-off to the most recent date of disease assessment. Participants without a post-BL disease assessment were censored at the time of first dose of study treatment.|Screening, Days 1 and 15 of Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.|ITT population||participants|||Number
773405|NCT00738374|Secondary|Percentage of Participants With Molecular CR - BM or Molecular CR - PB at the End of Study|Molecular CR was defined as the absence of MRD evaluated in participants who achieved CR by quantitative PCR in PB and BM B cells to confirm that tissue was comprised of non-CLL cells.|Month 35|All randomized participants analyzed for the given parameter at the specified timepoint.||percentage of participants|||Number
773406|NCT00738374|Secondary|Percentage of Participants With Immunophenotypic CR - BM or Immunophenotypic CR - PB at the End of Study|Immunophenotypic CR was defined as the absence of MRD evaluated in participants who achieved CR by 4-color flow cytometry of PB and BM B cells to confirm that tissue was comprised of non-CLL cells.|Month 35|All randomized participants, only participants with a confirmed CR were included in the analysis.||percentage of participants|||Number
773407|NCT00738374|Secondary|Percentage of Participants With CR, CRi, PR, SD, PD, or Relapse at the End of Study|CR, CRi, PR, SD, PD, relapse, and nodular PR as previously defined.|Month 35|All randomized participants.||percentage of participants|||Number
773408|NCT00738374|Secondary|Number of Participants With Immunophenotypic CR - BM, Immunophenotypic CR - Peripheral Blood (PB), Molecular CR - BM, or Molecular CR - PB at the End of Induction Treatment|Immunophenotypic CR was defined as the absence of minimal residual disease (MRD) evaluated in participants with CR by 4-color flow cytometry of PB and BM B cells to confirm that tissue was comprised of non-CLL cells. Molecular CR was defined as the absence of MRD evaluated in participants with CR by quantitative polymerase chain reaction (PCR) in PB and BM B cells to confirm that tissue was comprised of non-CLL cells.|Month 10|ITT population||participants|||Number
773409|NCT00738374|Secondary|Percentage of Participants With CR, PR, SD, PD, Relapse, or Nodular PR at the End of Study|CR, and PR as previously defined. PD was defined by 1 of the following: 1) lymphadenopathy: any new lesion, HM/SM, or other organ infiltrates, or a ≥ 50% increase in greatest diameter of any previously noted lesion; 2) a ≥50% increase in previously noted HM/SM, or new appearance of HM/SM; 3) a ≥50% increase in blood lymphocyte count with at least 5000 B lymphocytes/μL; 4) transformation to a more aggressive histology, e.g., Richter’s syndrome; or 5) occurrence of cytopenia attributable to CLL. SD was defined by the absence of necessary criteria to achieve CR or PR, but no advancement to PD. Relapse was defined by a previously noted CR or PR with advancement to PD after a period of ≥6 months. Nodular PR was defined by the presence of residual lymphoid nodules.|Month 35|All randomized participants who were assessed at Month 35 were included in the analysis.||percentage of participants|||Number
773410|NCT00738374|Secondary|Percentage of Participants With CR, CRi, PR, Stable Disease (SD), Progressive Disease (PD), Relapse, or Nodular PR at the End of Induction Treatment|CR, CRi, and PR as previously defined. PD was defined by 1 of the following: 1) lymphadenopathy: any new lesion, HM/SM, or other organ infiltrates, or a greater than or equal to (≥) 50% increase in greatest diameter of any previously noted lesion; 2) a ≥ 50% increase in previously noted HM/SM, or new appearance of HM/SM; 3) a ≥ 50% increase in blood lymphocyte count with at least 5000 B lymphocytes/μL; 4) transformation to a more aggressive histology, e.g., Richter’s syndrome; or 5) occurrence of cytopenia attributable to CLL. SD was defined by the absence of necessary criteria to achieve CR or PR, but no advancement to PD. Relapse was defined by a previously noted CR or PR with advancement to PD after a period of ≥ 6 months. Nodular PR was defined by the presence of residual lymphoid nodules.|Month 10|ITT population||percentage of participants|||Number
773411|NCT00738374|Secondary|Percentage of Participants With Documented CR, CRi, or PR at the End of Study|CR defined as: 1) laboratory CR: PBL <4000/μL, PMN > 1500/μL, platelets > 100,000/μL, and Hb > 11 g/dL; 2) clinical CR: LN < 1.5 cm, and no constitutional symptoms, HM or SM; 3) instrumental CR: LN < 1.5 cm and no HM/SM, and 4) bone marrow CR: normocellular aspirate/biopsy for participant age < 30% lymphocytes, and no B cell lymphoid nodules. CRi was defined as CR with anemia, thrombocytopenia, or neutropenia not related to CLL, with no clonal infiltrate in aspirate or biopsy. PR defined as: a 50% decrease in PBL, a 50% decrease in LN size, no increase in LN size, no new enlarged LN, a 50% reduction from BL in the HM/SM, and 1 of the following: PMN > 1500/μL, platelets > 100,000/μL or > 50% improvement from BL, and Hb >11.0 g/dL or > 50% improvement from BL.|Month 35|All randomized participants.||percentage of participants||95% Confidence Interval|Number
773434|NCT00738543|Primary|Bacterial Colony Forming Units for the 10% Sodium Hypochlorite Period|After incubation, the outcome assessor counted the colonies to determine the colony-forming units per square centimeter (CFU/cm2) of skin.|24 hours|||Colony-forming units per cm squared||Inter-Quartile Range|Median
775458|NCT00757484|Secondary|Surgical Time|Length of surgery|January 2007 to January 2008|||minutes||Full Range|Mean
773412|NCT00738374|Primary|Percentage of Participants With Documented CR, CRi, or PR at the End of Induction Treatment|CR defined as: 1) laboratory CR: peripheral blood lymphocytes (PBL) less than (<) 4000/microliter (μL), neutrophils (PMN) greater than (>) 1500/μL, platelets >100,000/μL, and hemoglobin (Hb) >11 grams per deciliter (g/dL); 2) clinical CR: lymph nodes (LN) <1.5 centimeter (cm), and no constitutional symptoms, hepatomegaly (HM) or splenomegaly (SM); 3) instrumental CR: LN <1.5 cm and no HM/SM, and 4) bone marrow (BM) CR: normocellular aspirate/biopsy for participant age <30 percent (%) lymphocytes, and no B cell lymphoid nodules. CRi was defined as CR with anemia, thrombocytopenia, or neutropenia not related to chronic lymphocytic leukemia (CLL), with no clonal infiltrate in aspirate or biopsy. PR defined as: a 50% decrease in PBL, a 50% decrease in LN size, no increase in LN size, no new enlarged LN, a 50% reduction from baseline (BL) in the HM/SM, and 1 of the following: PMN >1500/μL, platelets >100,000/μL or >50% improvement from BL, and Hb >11.0 g/dL or >50% improvement from BL.|Month 10|Intent to treat (ITT) population: all consented participants who received at least 1 dose of rituximab.||percentage of participants||95% Confidence Interval|Number
773413|NCT00738400|Secondary|Number of Participants Who Can Stay on the Initially Provided Dosage of Vardenafil (10 mg PRN (Pro re Nata))|Number of participants with no recorded titration of Vardenafil after visit 3.|week 4 and week 8|||Participants|||Number
773414|NCT00738400|Secondary|Change in Percentage From Baseline in Ability to Ejaculate (SEP6) at Week 8|Percent successful ejaculations were calculated per participant as the number of successful attempts (achievement of ejaculation) divided by the total number of attempts. The mean percent successful ejaculations was then calculated across all participants.|Baseline and 8 weeks|Number of participants analyzed differs due to missing data.||Percent successful ejaculations||95% Confidence Interval|Least Squares Mean
773415|NCT00738400|Secondary|Change in Percentage From Baseline in Ability to Obtain an Erection (SEP1) at Week 8|Percent successful erections were calculated per participant as the number of successful attempts (achievement of erection) divided by the total number of attempts. The mean percent successful erections was then calculated across all participants.|Baseline and 8 weeks|Number of participants analyzed differs due to missing data.||Percent successful erections||95% Confidence Interval|Least Squares Mean
773416|NCT00738400|Secondary|"Percentage of Participants Achieving Back to Normal Erectile Function at Week 8 or Last Observation Carried Forward (LOCF)"|Responders: percentage of participants achieving an IIEF-EF score >25.(IIEF-EF domain score: 6-30 ordinal points, specifying the severity of erectile dysfunction: 6-10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; 26-30 'no ED')|up to 8 weeks or LOCF|Number of participants analyzed differs due to missing data.||Percentage of participants|||Number
773417|NCT00738400|Primary|Change in Percentage From Baseline in Success of Erection Maintenance (SEP3: Sexual Encounter Profile Question 3) at Week 8|Percent successful maintenance of erection were calculated per participant as the number of successful attempts (maintenance of erection) divided by the total number of attempts. The mean percent successful maintenance of erection was then calculated across all participants.|Baseline and 8 weeks|Number of participants analyzed differs due to missing data.||Percent erection maintenance||95% Confidence Interval|Least Squares Mean
773418|NCT00738400|Primary|Change in Percentage From Baseline in Success of Penetration (SEP2: Sexual Encounter Profile Question 2) at Week 8|Percent successful penetrations were calculated per participant as the number of successful sexual attempts (penetrations) divided by the total number of attempts. The mean percent successful penetrations was then calculated across all participants.|Baseline and 8 weeks|Number of participants analyzed differs due to missing data.||Percent successful penetrations||95% Confidence Interval|Least Squares Mean
773419|NCT00738400|Primary|Change From Baseline in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Subscore at Week 8 or Last Observation Carried Forward (LOCF)|The primary variable was the least square (LS)-mean difference between treatment groups in the IIEF-EF domain score (6-30 ordinal points, specifying the severity of erectile dysfunction: 6-10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; 26-30 'no erectile dysfunction [ED]'). The target variable is the LS-mean difference between treatment groups at endpoint. The LS-means of both treatment groups are derived from a baseline-adjusted endpoint measure (week 8/last observation carried forward [LOCF]) as calculated via an ANCOVA.|baseline and up to 8 weeks or LOCF|Number of participants analyzed differs due to missing data.||Scores on a scale||95% Confidence Interval|Least Squares Mean
773420|NCT00738426|Secondary|Changes in Weight, Body Mass Index (BMI) and Scores on the Body Shape Questionnaire (BSQ).||4 weeks||||||
773421|NCT00738426|Primary|Incidence of the Reduction of at Least 3.0 Inches Off Their Combined Waist-hips-thighs Circumference.||2 weeks|||participants|||Number
773422|NCT00738530|Secondary|Change From Baseline in Karnofsky Performance Status|Karnofsky performance score is used to quantify participant’s general well-being and activities of daily life and participants were classified based on their functional impairment. Karnofsky performance score is 11 level score which ranges between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks.|Baseline, Week 7, 15, 23, 31, 43|Safety population: all participants randomized and exposed to study drug (8 randomized participants did not receive study treatment and were not included, 2 in bevacizumab and 6 in placebo group). 12 participants randomized to placebo received bevacizumab, were included in bevacizumab arm. n=number of evaluable participants at specified time point.||score on a scale||Full Range|Median
773423|NCT00738530|Secondary|Percentage of Participants With Best Overall Response According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST)|Best response recorded from the start of treatment until disease progression. Based on assessment of CR, PR, stable disease (SD), or progressive disease (PD), according to mRECIST. CR: disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR: >=30% decrease under baseline of the sum of the LD of all target lesions. CR and PR persist on repeat imaging study at least 4 weeks after initial documentation. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Reference is the smallest sum LD. PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions.|Baseline until disease progression or death, whichever occurred first (assessed at baseline, Weeks 8, 16, 24, 32, 44, 56, 68 thereafter every 12 weeks up to week 104 and then every 6 months up to 4.25 years)|ITT population included all participants randomized into the study. Number of participants analyzed (N) = participants with measurable disease at baseline.||percentage of participants|||Number
773424|NCT00738530|Secondary|Percentage of Participants With Objective Response According to mRECIST|Objective response referred to participants with complete response (CR) or partial response (PR). CR: disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR: greater than or equal to (>=) 30% decrease in sum of the longest diameter (LD) of all target lesions taking as reference the screening sum LD. To be assigned a status of PR or CR, changes in tumor measurements had to be confirmed by repeat assessments that should have been performed no less than 4 weeks after the criteria for response were first met. Longer intervals as determined by the study protocol were also appropriate.|Baseline until disease progression or death, whichever occurred first (assessed at baseline, Weeks 8, 16, 24, 32, 44, 56, 68 thereafter every 12 weeks up to week 104 and then every 6 months up to 4.25 years)|ITT population included all participants randomized into the study. Number of participants analyzed (N) = participants with measurable disease at baseline.||percentage of participants|||Number
773425|NCT00738530|Secondary|Time to Treatment Failure (TTF) According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST)|Time to treatment failure was defined as the time between the date of randomization and the date of insufficient therapeutic response (including disease progression), death, withdrawal of treatment due to adverse events or laboratory abnormality, or withdrawal of informed consent. Tumor assessment was performed using mRECIST. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions. Participants without an event were censored at the date of last tumor assessment or last treatment administration, whichever occurred last. Participants who were randomized but not exposed to study drug and had no further follow-up were censored on the day of randomization.|Baseline until disease progression or death, whichever occurred first (assessed at baseline, Weeks 8, 16, 24, 32, 44, 56, 68 thereafter every 12 weeks up to week 104 and then every 6 months up to 4.25 years)|ITT population included all participants randomized into the study.||months||95% Confidence Interval|Median
773426|NCT00738530|Secondary|Percentage of Participants With Treatment Failure|Treatment failure is defined as insufficient therapeutic response (including disease progression), death, withdrawal of treatment due to adverse events or laboratory abnormality, or withdrawal of informed consent. Tumor assessment was performed using mRECIST. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions.|Baseline until disease progression or death, whichever occurred first (assessed at baseline, Weeks 8, 16, 24, 32, 44, 56, 68 thereafter every 12 weeks up to week 104 and then every 6 months up to 4.25 years)|ITT population included all participants randomized into the study.||percentage of participants|||Number
773427|NCT00738530|Secondary|Time to Progression (TTP) According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST)|Time to progression was defined as the time between date of randomization and date of documented progression. Tumor assessment was performed using mRECIST. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions. Participants without an event (including participants who died before progressive disease) were censored at the date of last follow-up for progression or date of last available tumor measurement if no follow-up assessment for progression was performed. Participants who were randomized but not exposed to study drug and had no further follow-up were censored on the day of randomization.|Baseline until disease progression or death, whichever occurred first (assessed at baseline, Weeks 8, 16, 24, 32, 44, 56, 68 thereafter every 12 weeks up to week 104 and then every 6 months up to 4.25 years)|ITT population included all participants randomized into the study.||months||95% Confidence Interval|Median
773428|NCT00738530|Secondary|Progression Free Survival (PFS) According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST)|Progression-free survival was defined as the time between the date of randomization and the first date of documented progression or date of death due to any cause, whichever occurred first. Tumor assessment was performed using modified RECIST. Progressive disease was defined as at least a 20 percentage(%) increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions. Participants without an event were censored at the date of last follow-up for progression or date of last available tumor measurement if no follow-up assessment for progression was performed. Participants who were randomized but not exposed to study drug and had no further follow-up were censored on the day of randomization.|Baseline until disease progression or death, whichever occurred first (assessed at baseline, Weeks 8, 16, 24, 32, 44, 56, 68 thereafter every 12 weeks up to week 104 and then every 6 months up to 4.25 years)|ITT population included all participants randomized into the study.||months||95% Confidence Interval|Median
773429|NCT00738530|Secondary|Percentage of Participants With Disease Progression or Death|Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions.|Baseline until disease progression or death, whichever occurred first (assessed at baseline, Weeks 8, 16, 24, 32, 44, 56, 68 thereafter every 12 weeks up to week 104 and then every 6 months up to 4.25 years)|ITT population included all participants randomized into the study.||percentage of participants|||Number
773430|NCT00738530|Primary|Overall Survival (OS) Duration|Duration of survival was defined as the time between the date of randomization and date of death due to any cause. Participants still alive at the time of analysis were censored at the date they were last known to be alive. Kaplan-Meier estimates were used for analysis.|Baseline until death (up to 4.25 years)|ITT population included all participants randomized into the study.||months||95% Confidence Interval|Median
773431|NCT00738530|Primary|Percentage of Participants Who Died||Baseline up to 4.25 years|ITT population included all participants randomized into the study.||percentage of participants|||Number
773432|NCT00738543|Secondary|Presence af Allergy or Skin Reaction for the 10% Sodium Hypochlorite Period|Presence of allergy or skin reaction at 24 hours after the application of the antiseptic|24 hours|||Number of participants with reaction|||Number
773435|NCT00738543|Secondary|Presence of Skin Reactions for the 10% Povidone-iodine Period|Presence of allergy or any skin reaction at 24 hours after the antiseptic application|24 hours|A minimal sample of 20 volunteers was calculated to find a difference of 200 CFU/mL, with a power of 80%, and bilateral error of 5%. Analysis per protocol.||Number of participants with skin reactio|||Number
773436|NCT00738543|Primary|Bacterial Count of Skin Cultures for the 10% Povidone-iodine Period|Bacterial colony count of skin cultures to determine antiseptic properties|24 hours|||Colony-forming units per cm squared||Inter-Quartile Range|Median
773437|NCT00738673|Secondary|Kaplan-Meier Estimate for Overall Survival|The overall survival time was defined as number of days from first treatment dose to date of death. If a patient did not die then the patient’s data were censored at the date of last visit.|up to month 12|"Intent to treat population.
Analysis was not performed since no participants died during study."|||||
773438|NCT00738673|Secondary|Participants With Prostate-Specific Antigen (PSA) Progression Throughout the Study|Counts of participants who had PSA progression during the study. PSA progression was defined as PSA >+10% of baseline value.|up to month 12|Intent to treat population||participants|||Number
773439|NCT00738673|Secondary|Participants at Testosterone Level <=0.32 ng/mL Throughout the Study|Participants in Cohort 2 who had no post-baseline serum testosterone level above 0.32 ng/mL|up to month 12|Full analysis set. Per the protocol, this analysis was only performed on Cohort 2.||participants|||Number
773440|NCT00738673|Secondary|Participants at Testosterone Level <=0.2 ng/mL Throughout the Study|Participants in Cohort 2 who had no post-baseline serum testosterone level above 0.2 ng/mL.|up to month 12|Full analysis set. Per the protocol, this analysis was only performed on Cohort 2.||participants|||Number
773441|NCT00738673|Secondary|Change From Baseline in Serum Levels of Follicle-Stimulating Hormone (FSH) at the Last Visit||Day 0 (baseline), up to month 12 (last visit)|Intent to treat population with a baseline and at least one scheduled post-baseline measurement.||IU/L||Standard Deviation|Mean
773442|NCT00738673|Secondary|Percent Change From Baseline in Serum Levels of Luteinising Hormone (LH) at the Last Visit|LH is measured in IU/L|Day 0 (baseline), up to month 12 (last visit)|Intent to treat population with a baseline and at least one scheduled post-baseline measurement.||percentage of baseline||Standard Deviation|Mean
773443|NCT00738673|Secondary|Change From Baseline in Serum Levels of Prostate-Specific Antigen (PSA) at Last Visit||Day 0 (baseline), up to month 12 (last visit)|Intent to treat population with a baseline and at least one scheduled post-baseline measurement.||ng/mL||Standard Deviation|Mean
773444|NCT00738673|Secondary|Change From Baseline in Serum Levels of Testosterone at the Last Visit||Day 0 (baseline), up to month 12 (last visit)|Intent to treat population with a baseline and at least one scheduled post-baseline measurement.||ng/mL||Standard Deviation|Mean
773445|NCT00738673|Secondary|Participants at Testosterone Castrate Level Throughout the Study|Participants who had no post-baseline serum testosterone level above castrate level which was <=0.5 ng/mL.|up to month 12|Intent to treat population||participants|||Number
773446|NCT00738673|Secondary|Participants' Response in Prostate-Specific Antigen (PSA) Level at Two Months As Compared to Baseline|"Response to treatment was defined as:
Response (stabilisation or decrease): Difference ≤ +10% of Baseline level
No response (increase): Difference > +10% of Baseline level.
Per protocol, the two month timeframe was only analyzed for cohort 2."|Day 0 (baseline), 2 months|Full analysis set of participants with baseline and month 2 values. Per protocol, the two month timeframe was only analyzed for cohort 2.||percentage of participants||95% Confidence Interval|Number
773447|NCT00738673|Secondary|Participants’ Response in Prostate-Specific Antigen (PSA) Level at One Month As Compared to Baseline|"Response to treatment was defined as:
Response (stabilisation or decrease): Difference ≤ +10% of Baseline level
No response (increase): Difference > +10% of Baseline level.
Per protocol, the one month timeframe was only analyzed for cohort 2."|Day 0 (baseline), 1 month|Full analysis set of participants with baseline and month 1 values. Per protocol, the one month timeframe was only analyzed for cohort 2.||percentage of participants||95% Confidence Interval|Number
773448|NCT00738673|Primary|Participants’ Response in Prostate-Specific Antigen (PSA) Level at Three Months As Compared to Baseline|"Response to treatment was defined as:
Response (stabilisation or decrease): Difference ≤ +10% of Baseline level
No response (increase): Difference > +10% of Baseline level"|Day 0 (baseline), 3 months|Intent to treat population. Last observation carried forward.||percentage of participants||95% Confidence Interval|Number
773449|NCT00738699|Other Pre-specified|Serologic Response Rate|Due to termination of the study, data were not collected and the outcome measure for Serologic Response Rate was not analyzed.|Length of study|Due to termination of the study, data were not collected and the outcome measure for Serologic Response Rate was not analyzed.|||||
773450|NCT00738699|Other Pre-specified|Progression Free Survival Based on Gynecologic Cancer InterGroup (GCIG)|Due to termination of the study, data were not collected and the outcome measure for PFS based on GCIG was not analyzed.|Length of study|Due to termination of the study, data were not collected and the outcome measure for PFS based on GCIG was not analyzed.|||||
773451|NCT00738699|Secondary|Time to Tumor Response (TTR)|TTR was derived for those participants with objective evidence of CR or PR, and was defined as the time (in months) from the date of randomization to the first documentation of object tumor response (TR). Analysis was based on the Kaplan-Meier estimated percentage of responders. This statistical analysis method measures the effect of study drug on tumor response over a period of time.|Date of Randomization to the first documentation of objective TR, assessed up to study termination (28 Nov 2011), or up to approximately 2 years 10 months|ITT population (Responders only) included all participants who were randomly assigned to study drug and analyzed by the treatment assigned.||Months||95% Confidence Interval|Median
773464|NCT00739050|Primary|Change From Baseline in Endothelial Thickness After 12 Weeks of Treatment.|The study was terminated; no outcome measure data analyses were conducted.|Baseline and 12 weeks|The study was terminated; no outcome measure data analyses were conducted. The Investigator was not able to recruit the required patients and was not able to get the necessary Computed Tomography equipment.|||||
773513|NCT00739674|Secondary|Number of Patients Achieving Target Blood Pressure at Week 10 From Baseline|Number of Patients Achieving Target Blood Pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics) from baseline after 10 weeks of treatment|10 Weeks|463 and 400 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 399 and 370 patients at week 10 for L group and DML group respectively.||Participants|||Number
773452|NCT00738699|Secondary|Best Overall Response|BOR was defined as the percentage of participants having either a confirmed complete response (CR) or confirmed partial response (PR) using modified RECIST criteria by independent radiologist review. RECIST criteria was adjusted based on current medical practices and on possible differences between ovarian cancer and other solid tumors. Tumor assessments performed up to the initiation of further antitumor treatment were considered. Target lesions selected for response assessment were measured using computed tomography (CT) or magnetic resonance imaging (MRI) scans then graded according to the modified RECIST criteria, adjusted based on current medical practices and on possible differences between ovarian cancer and other solid tumors. Participants were assigned to one of the categories of change in disease state; CR, PR, progressive disease (PD), stable disease ( S)D, or not evaluable (NE).|Date of first study drug to disease progression/recurrence, assessed up to study termination (28 Nov 2011), or up to approximately 2 years 10 months|ITT population included all participants who were randomly assigned to study drug and analyzed by the treatment assigned.||Percentage of participants|||Number
773453|NCT00738699|Primary|Overall Survival (OS)|OS was defined as the time (in months) from the date of randomization to the date of death, whatever the cause. If death was not observed for a participant, the survival time was censored on the last date the participant was known to be alive or the cutoff date, whichever was earlier.|Date of Randomization to date of death, assessed up to study termination (28 Nov 2011), or up to approximately 2 years 10 months|ITT population included all participants who were randomly assigned to study drug and analyzed by the treatment assigned.||Months||95% Confidence Interval|Median
773454|NCT00738699|Primary|Progression-Free Survival (PFS)|PFS was defined as the time (in months) from the date of randomization to the date of the first observation of progression as determined by modified Response Evaluation Criteria in Solid Tumors (RECIST), or death regardless of cause. If progression or death was not observed, the PFS time was censored at the date of the last tumor assessment without evidence of progression before the date of initiation of further antitumor treatment, or the cutoff date (whichever was earlier).|Date of Randomization to date of disease progression or death (whichever came first), assessed up to study termination (28 Nov 2011), or up to approximately 2 years 10 months|Intent-To-Treat (ITT) population included all participants who were randomly assigned to study drug, analyzed by treatment assignment.||Months||95% Confidence Interval|Median
773455|NCT00738881|Secondary|Confirmed Response Rate Defined as Complete Response (CR) or a Partial Response (PR) Per Response Evaluation Criteria In Solid Tumors (RECIST)|Responses will be summarized by simple descriptive summary statistics delineating complete and partial responses as well as stable and progressive disease. The proportion of patients with confirmed CR and PR will be computed within each treatment arm and exact binomial confidence intervals for the true proportion computed. Chi-square test and Fisher’s exact test will be used to compare the response rates between the treatment arms within the subgroups defined by FISH status, IHC, and MUT.|Up to 5 years|Since the trial closed prematurely with only ~2% accrual, the secondary outcomes were not analyzed.|||||
773456|NCT00738881|Secondary|Overall Survival|Will be estimated using the method of Kaplan-Meier survival curves. A 1-sided stratified log rank test [accounting for all the stratification factors except FISH status and cooperative group] will be used to compare overall survival between the erlotinib and pemetrexed arms within the FISH(+) and FISH(-) subgroups, compare overall and progression free survival between the erlotinib and pemetrexed arms within the subgroups defined on the basis of the epidermal growth factor receptor (EGFR) expression by immunohistochemistry (IHC), and EGFR gene mutation status (MUT). Cox proportional hazards model will be used to assess potential differences.|Time from randomization to time of death from any cause, assessed up to 5 years|Since the trial closed prematurely with only ~2% accrual, the secondary outcomes were not analyzed.|||||
773457|NCT00738881|Secondary|Time to Treatment Failure|The distribution of all time to event data will be estimated using the method of Kaplan-Meier survival curves.|The time from date of randomization to the date at which the patient is removed from the treatment, assessed up to 5 years|Since the trial closed prematurely with only ~2% accrual, the secondary outcomes were not analyzed.|||||
773458|NCT00738881|Primary|Progression-free Survival (PFS)|Estimated using the method of Kaplan-Meier survival curves to compare PFS between the erlotinib and pemetrexed arms using an intent-to-treat (ITT) analysis. Due to the small sample size (21 of the required 954 patients ~2%), analyses within the FISH(+) and FISH(-) groups were not performed, and no formal analyses for the primary or the secondary efficacy outcomes were performed.|Time from randomization to the first date of documented disease progression or death, assessed up to 5 years|All the 23 randomized patients are eligible for primary end point analysis using an ITT principle.||months||95% Confidence Interval|Median
773460|NCT00739024|Primary|T-Test|It was planned to use a simple T-Test or ANoVa for data analysis. No Analysis was made due to insufficient recruitment. Planned primary efficacy variable was the percent reduction in the average monthly miqraine/probable migraine frequency from the baseline period to the entire double-blind treatment phase of the study.|4 weeks||||||
773461|NCT00739050|Secondary|Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) After 12 Weeks of Treatment|The study was terminated; no outcome measure data analyses were conducted.|Baseline and 12 weeks|The study was terminated; no outcome measure data analyses were conducted. The Investigator was not able to recruit the required patients and was not able to get the necessary Computed Tomography equipment.|||||
773462|NCT00739050|Secondary|Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) After 12 Weeks of Treatment|The study was terminated; no outcome measure data analyses were conducted.|Baseline and 12 weeks|The study was terminated; no outcome measure data analyses were conducted. The Investigator was not able to recruit the required patients and was not able to get the necessary Computed Tomography equipment.|||||
773463|NCT00739050|Secondary|Change in Total Cholesterol From Baseline at Week 12|The study was terminated; no outcome measure data analyses were conducted.|Baseline and 12 weeks|The study was terminated; no outcome measure data analyses were conducted. The Investigator was not able to recruit the required patients and was not able to get the necessary Computed Tomography equipment.|||||
789734|NCT00867139|Secondary|Number of Patients Not Shedding Virus at Day 5 +/-1 and Day 10 +/- 1||10 days|Participants assessed for viral shedding were those with available baseline viral load data.||participants|||Number
773465|NCT00739063|Primary|Time to Progression (TTP)|Time to progression calculated from the date of study entry to the date of disease progression or death. Progression of disease is defined by RECIST (Response Evaluation Criteria In Solid Tumors) criteria, as measurable increase in the smallest dimension of any target or not-target lesion, or the appearance of new lesions, since baseline. Confirmed response based on two tumor assessments (imaging) separated by at least 4 weeks.|Baseline to disease progression, up to 22 months with follow up.|Study terminated early, unable to complete overall analysis due to insufficient data.||months|||Number
773466|NCT00739102|Secondary|Major Adverse Events at 12-month Post Procedure|Major adverse events included death, index limb ischemia, index limb amputation, clinically driven TLR, and significant embolic events, which were defined as causing end-organ damage.|12 months|Active subjects in the Modified ITT population at 12-month post procedure||participants|||Number
773467|NCT00739102|Secondary|Rutherford / Becker Classification Category at 12-month Follow Up||12 months|Active subjects in the Modified ITT population at 12-month post procedure||participants|||Number
773468|NCT00739102|Secondary|Rutherford/Becker Classification at 30-day Follow Up|"The Rutherford/Becker Classification is a commonly used clinical staging system which allows clinicians to describe and discuss patients with peripheral artery disease. The classification has seven stages as follows:
Stage 0 – Asymptomatic, no hemodynamically significant occlusive disease
Stage 1 – Mild claudication
Stage 2 – Moderate claudication
Stage 3 – Severe claudication
Stage 4 – Ischemic rest pain
Stage 5 – Minor tissue loss, non-healing ulcer, focal gangrene with diffuse pedal ischemia
Stage 6 – Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable"|30 days|Active subjects in the Modified ITT population at 30-day post procedure||participants|||Number
773469|NCT00739102|Secondary|Index Limb Ischemia at 12-month Follow up|Index Limb Ischemia is defined by Rutherford/Becker Classification categories 3 through 6.|12 months|Active subjects in the Modified ITT population at 12-month post procedure||participants|||Number
773470|NCT00739102|Primary|Primary Safety Endpoint|Primary safety endpoint is defined as the rate of freedom from all causes of death, index limb amputation, and clinically driven target lesion revascularization (TLR) through 30 days. A clinically driven TLR is any intervention in the stented target lesion following documented recurrent symptomatic leg ischemia by Rutherford/Becker Classification (category 2, 3 or 4), with a resting or exercise ABI ≤ 0.8 and >50% diameter in-lesion stenosis by angiography. Revascularization of a target lesion with an in-lesion diameter stenosis of >70% by angiography, in the absence of the previously mentioned ischemic signs or symptoms, will also be considered clinically driven.|30 days|Active subjects in the Modified ITT population at 30 days post procedure||participants|||Number
773471|NCT00739102|Secondary|Index Limb Ischemia at 6-month Follow up|Index Limb Ischemia is defined by Rutherford/Becker Classification categories 3 through 6.|6 months|Active subjects in the Modified ITT population at 6-month post procedure||participants|||Number
773472|NCT00739102|Secondary|Stent Fracture at 12-month Follow Up|Stent fracture was assessed by x-ray evaluation.|12 months|Active subjects in the Modified ITT population at 12-month post procedure||participants|||Number
773473|NCT00739102|Secondary|Clinically Driven Target Vessel Revascularization (TVR) at 12-month Post Procedure|A clinically driven TVR is any intervention of the target vessel following documented recurrent symptomatic leg ischemia by Rutherford/Becker Classification (category 2, 3 or 4), with a resting or exercise Ankle-Brachial Index (ABI) ≤ 0.8 and >50% diameter in-lesion stenosis by angiography. Revascularization of a target vessel with an in-lesion diameter stenosis of >70% by angiography, in the absence of the previously mentioned ischemic signs or symptoms, will also be considered clinically driven.|12 months|Active subjects in the Modified ITT population at 12-month post procedure||participants|||Number
773474|NCT00739102|Secondary|Clinically Driven Target Vessel Revascularization (TVR) at 30-day Post Procedure|A clinically driven TVR is any intervention of the target vessel following documented recurrent symptomatic leg ischemia by Rutherford/Becker Classification (category 2, 3 or 4), with a resting or exercise Ankle-Brachial Index (ABI) ≤ 0.8 and >50% diameter in-lesion stenosis by angiography. Revascularization of a target vessel with an in-lesion diameter stenosis of >70% by angiography, in the absence of the previously mentioned ischemic signs or symptoms, will also be considered clinically driven.|30 days|Active subjects in the Modified ITT population at 30-day post procedure||participants|||Number
773475|NCT00739102|Secondary|Index Limb Amputation at 30-day Follow up|Index Limb Amputation is defined as surgical removal of all or part of the lower extremity from the toe up.|30 day|Active subjects in the Modified ITT population at 30 days post procedure||participants|||Number
773476|NCT00739102|Secondary|Death at 12-month Post Procedure||12 months|Active subjects in the Modified ITT population at 12-month post procedure||participants|||Number
773477|NCT00739102|Secondary|Death Rate at 30-day Post Procedure||30 days|Active subjects in the Modified ITT population at 30-day post procedure||participants|||Number
773478|NCT00739102|Primary|12-month Primary Patency Rate|Primary patency is defined as no significant reduction of flow detectable by Duplex ultrasound through the index lesion and no further clinically driven target vessel revascularization performed in the interim. Significant reduction of flow is binary restenosis defined as the diameter stenosis >50% with a peak systolic velocity ratio >2.0 as measured by Duplex ultrasound.|12 months|As a subset of the modified ITT, this analysis population consisted of the subjects who had ultrasound assessment at 12 months or had target vessel revascularization (TVR) performed by 12 months.||participants|||Number
773479|NCT00739297|Other Pre-specified|Change From Baseline in FEV1 at 24 Hours After Treatment With Montelukast|Average change from baseline in FEV1 at 24 hours after single dose montelukast administration.|0 (baseline) and 24 hours after treatment with montelukast|Full analysis set (FAS) population which included all randomized patients who took at least one dose of post randomization study drug (Montelukast or placebo) at either of the intervention visits and had a measurement for analysis available in at least one treatment period of the cross-over design.||L||95% Confidence Interval|Least Squares Mean
773480|NCT00739297|Other Pre-specified|Change From Baseline in FEV1 at 8 Hours After Treatment With Montelukast|Average change from baseline in FEV1 at 8 hours after single dose montelukast administration.|0 (baseline) and 8 hours after treatment with montelukast|Full analysis set (FAS) population which included all randomized patients who took at least one dose of post randomization study drug (Montelukast or placebo) at either of the intervention visits and had a measurement for analysis available in at least one treatment period of the cross-over design.||L||95% Confidence Interval|Least Squares Mean
773481|NCT00739297|Secondary|Change From Baseline in FEV1 Over 90 Minutes After Albuterol/Placebo Administration|FEV1 measurements taken at 0 (=baseline), 15, 30, 60, and 90 minutes after albuterol/placebo administration contributed to the average change from baseline over 90 minutes. The number of minutes between consecutive measurements was used as weighting factor. The time-weighted average change was standardized by dividing by the time associated with the last measurement.|4 hours (equals time point at which albuterol or albuterol placebo is administered) to 5.5 hours after treatment with montelukast|Full analysis set (FAS) population which included all randomized patients who took at least one dose of post randomization study drug (albuterol or matching placebo) 4 hours after treatment with montelukast at either of the intervention visits and had a measurement for analysis available in at least one treatment period of the cross-over design.||L||95% Confidence Interval|Least Squares Mean
773482|NCT00739297|Primary|Change From Baseline in FEV1 Over 4 Hours|FEV1 measurements taken at 0 (=baseline), 10, 20, 30, 45, 60, 120, 180 and 240 minutes contributed to the average change from baseline over 4 hours. The number of minutes between consecutive measurements was used as weighting factor. The time-weighted average change was standardized by dividing by the time associated with the last measurement.|0 (=baseline) to 4 hours after treatment with montelukast|Full analysis set (FAS) population which included all randomized patients who took at least one dose of post randomization study drug (Montelukast or placebo) at either of the intervention visits and had a measurement for analysis available in at least one treatment period of the cross-over design.||L (Liter)||95% Confidence Interval|Least Squares Mean
773483|NCT00739310|Primary|Hospitalizations Lasting at Least 24 Hours in This Patient Population|Hospitalizations lasting at least 24 hours|end of study|||hospitalizations|||Number
773484|NCT00739336|Secondary|Questionnaires||baseline, 3, 6, 12 months||||||
773485|NCT00739336|Secondary|Waist Circumference||baseline, 3, 6, 12 months||||||
773486|NCT00739336|Secondary|Hemoglobin A1c|hemoglobin A1c (%)|baseline|||percent||Standard Deviation|Mean
773487|NCT00739336|Secondary|Fasting Lipid Profile|LDL-cholesterol (mg/dL)|Baseline|||mg/dL||Standard Deviation|Mean
773488|NCT00739336|Secondary|Fasting Glucose Level|Fasting glucose (mg/dL)|Baseline|||mg/dL||Standard Deviation|Mean
773489|NCT00739336|Primary|Body Weight|Weight loss in kg|3 months|"Participants from the wait-list Control Arm have been combined in the Intervention Arm with those receiving the intervention immediately upon study entry for the purposes of this analysis."||kg||95% Confidence Interval|Mean
773490|NCT00739583|Secondary|Judgment of Reviewing Orthopaedic Surgeons That the Site Marking is Identifiable for Them to Perform Site Identification|The number of sets of initials judged by the viewing orthopedic surgeons as sufficient for adequate site identification. Each participant was labeled with three initials to simulate a surgeon's initials. Ten orthopaedic surgeons determined if the initials were visible enough to allow for site identification. Each surgeon viewed all of the sets of initials, resulting in 100 viewed sets of initials in each group.|at time of surgery, approximately ten minutes|||sets of intials|Participants||Number
773491|NCT00739583|Secondary|The Mean Change in Gray Level (Contrast) of the Horizontal Line|The Mean change in gray level of the ink line as expressed in units between pre and post skin preparation. Gray level is a unitless value from 0-255 describing the brightness of a pixel (0 being black and 255 being white).|at time of surgery, approximately ten minutes|||gray level units|Participants|Standard Deviation|Mean
773492|NCT00739583|Primary|Identification of the Random Initials by the Reviewing Orthopaedic Surgeons|The number of correctly identified initials as viewed by the orthopaedic surgeons. 10 participants were randomized to each study group. Each patient was marked with three initials. Each was viewed by ten surgeons giving a total of 300 initials for each group.|at time of surgery, approximately 10 minutes|||number of correctly identified initals|Participants||Number
773493|NCT00739596|Secondary|Percentage of Participants Achieving BP Control After 8 Weeks of Treatment|To compare the percentage of patients achieving BP control (<140/90 mm Hg) after 8 weeks of treatment with an aliskiren HCTZ-based treatment regimen (aliskiren HCTZ 150/12.5 mg, 300/25 mg) versus an amlodipine-based treatment regimen (amlodipine 5 mg, 10 mg) in African American patients with stage 2 hypertension.|8 weeks|The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study medication and had at least one valid post-baseline assessment of the primary efficacy variable.||Cumulative percentage of participants|||Number
773494|NCT00739596|Secondary|Percentage of Responders After 8 Weeks of Treatment.|To compare the percentage of responders after 8 weeks of treatment with an aliskiren HCTZ based treatment regimen (aliskiren HCTZ 150/12.5 mg, 300/25 mg) versus an amlodipine-based treatment regimen (amlodipine 5 mg, 10 mg) in African American patients with stage 2 hypertension: [ Responders were defined as patients with MSSBP < 140 mm Hg or a decrease from baseline ≥ 20 mm Hg at 1st response. A response was counted when a patient first achieved MSSBP < 140 mm Hg or a decrease from baseline ≥ 20 mm Hg.]|8 weeks|The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study medication and had at least one valid post-baseline assessment of the primary efficacy variable.||Cumulative percentage of responders|||Number
773495|NCT00739596|Secondary|Change in Mean Sitting Pulse Pressure (MSPP) After 8 Weeks of Treatment|To compare the change from baseline in mean sitting pulse pressure (MSPP) after 8 weeks of treatment with an aliskiren HCTZ-based treatment regimen (aliskiren HCTZ 150/12.5 mg, 300/25 mg) versus an amlodipine-based treatment regimen (amlodipine 5 mg, 10 mg) in African American patients with stage 2 hypertension.|Baseline and 8 weeks|The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study medication and had at least one valid post-baseline assessment of the primary efficacy variable. Last observation carried forward (LOCF) method was used for replacing missing values with post-baseline assessments.||mm Hg||Standard Deviation|Mean
773496|NCT00739596|Secondary|Change in Mean Sitting Diastolic Blood Pressure (MSDBP) After 8 Weeks of Treatment|To assess the change from baseline in mean sitting diastolic blood pressure (MSDBP) after 8 weeks of treatment with an aliskiren HCTZ-based treatment regimen (aliskiren HCTZ 150/12.5 mg, 300/25 mg) versus an amlodipine-based treatment regimen (amlodipine 5 mg, 10 mg) in African American patients with stage 2 hypertension.|Baseline and 8 weeks|The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study medication and had at least one valid post-baseline assessment of the primary efficacy variable. Last observation carried forward (LOCF) method was used for replacing missing values with post-baseline assessments.||mm Hg||Standard Deviation|Mean
773497|NCT00739596|Primary|Change in Mean Sitting Systolic Blood Pressure (MSSBP) After 8 Weeks of Treatment|To assess the change from baseline in MSSBP after 8 weeks of treatment with an aliskiren HCTZ-based treatment regimen (aliskiren HCTZ 150/12.5 mg, 300/25 mg) versus an amlodipine-based treatment regimen (amlodipine 5 mg, 10 mg) in African American patients with stage 2 hypertension.|Baseline and 8 weeks|The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study medication and had at least one valid post-baseline assessment of the primary efficacy variable. Last observation carried forward (LOCF) method was used for replacing missing values with post-baseline assessments.||mm Hg||Standard Deviation|Mean
773498|NCT00739648|Secondary|Percent Change in Forced Expiratory Volume in 1 Second (FEV1)|The percent change in the amount of air a patient can exhale in 1 second|from baseline to the conclusion of the fourth 28-day treatment cycle (4 months)|MITT||Percent||Standard Error|Least Squares Mean
773499|NCT00739648|Secondary|Percent Change in Forced Vital Capacity (FVC)|The percent change in the amount of air a patient can inhale|from baseline to the conclusion of the fourth 28-day treatment cycle (4 months)|MITT||Percent||Standard Error|Least Squares Mean
773500|NCT00739648|Secondary|Duration of Acute Exacerbation|From the beginning of antibiotics and/or systemic corticosteroids to the end of antibiotics and/or systemic corticosteroids, whichever was longer, for treatment of the first acute exacerbation|from randomization to the patient's final study visit (up to 12 months)|MITT||Days||Standard Deviation|Mean
773501|NCT00739648|Primary|Exacerbation Rate|The number of acute exacerbations per patient-year of study participation, where an acute exacerbation was defined as a deterioration in respiratory symptoms that required treatment with antibiotics, corticosteroids, hospitalization or a combination of those treatments.|From randomization to the patients final study visit (up to 12 months)|modified intent to treat (MITT; patients who received at least one dose of study drug)||exacerbation per patient year||Standard Error|Mean
773502|NCT00739661|Secondary|Overall Survival|Overall survival was defined as the time from randomization until death by any cause.|From randomization date through the data cut-off date of May 15, 2010, up to 100 weeks|Intent-to-treat patient population: All randomized patients.||Months||Standard Deviation|Mean
773503|NCT00739661|Secondary|Progression-free Survival (PFS) in Patients With Versus Without Hedgehog Antigen Tumor Expression|Hedgehog antigen expression was measured with immunohistochemical methods in tumor tissue taken from each patient prior to enrollment in the study. The percentage of cells with (> 0%) and without (0%) Hedgehog antigen expression was measured microscopically. PFS was defined as the time between randomization and disease progression, as confirmed by radiography, or death for any reason. Tumor assessments by computed tomography (CT) of the chest, abdomen, and pelvis were performed at screening and every 8 weeks during the study.|From randomization date through the data cut-off date of May 15, 2010, up to 100 weeks|Intent-to-treat patient population: All randomized patients. Tissue for evaluation was only available for 29 patients in the vismodegib group and 28 patients in the placebo group.||Months||95% Confidence Interval|Median
773504|NCT00739661|Primary|Progression-free Survival (PFS)|PFS was defined as the time between randomization and disease progression, as confirmed by radiography, or death for any reason. Since patients were in remission at the start of the study, they had no evidence of the presence of tumors. Disease progression was defined as radiographic evidence of a tumor. Tumor assessments by computed tomography (CT) of the chest, abdomen, and pelvis were performed at screening and every 8 weeks during the study.|From randomization date through the data cut-off date of May 15, 2010, up to 100 weeks|Intent-to-treat patient population: All randomized patients.||Months||95% Confidence Interval|Median
773505|NCT00739674|Secondary|Time to Achieve the Target Blood Pressure From Baseline|Time to achieve the target blood pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics).|14 Weeks|463 and 400 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 437 and 386 patients for L group and DML group respectively.||Weeks||95% Confidence Interval|Median
773506|NCT00739674|Secondary|Change in Diastolic Blood Pressure From Baseline to Week 10||10 Weeks|463 and 400 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 399 and 370 patients at week 10 for L group and DML group respectively.||mm Hg||Standard Deviation|Mean
773507|NCT00739674|Secondary|Change in Systolic Blood Pressure From Baseline to Week 10||10 Weeks|463 and 400 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 399 and 370 patients at week 10 for L group and DML group respectively.||mm Hg||Standard Deviation|Mean
773508|NCT00739674|Secondary|Change in Diastolic Blood Pressure From Baseline to Week 6||6 Weeks|463 and 400 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 431 and 383 patients at week 6 for L group and DML group respectively.||mm Hg||Standard Deviation|Mean
773509|NCT00739674|Secondary|Change in Systolic Blood Pressure From Baseline to Week 6||6 Weeks|463 and 400 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 431 and 383 patients at week 6 for L group and DML group respectively.||mm Hg||Standard Deviation|Mean
773510|NCT00739674|Primary|Change in Diastolic Blood Pressure From Baseline to Week 14||14 Weeks|463 and 400 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 392 and 357 patients at week 14 for L group and DML group respectively.||mm Hg||Standard Deviation|Mean
773511|NCT00739674|Primary|Change in Systolic Blood Pressure From Baseline to Week 14||14 Weeks|463 and 400 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 392 and 357 patients at week 14 for L group and DML group respectively.||mm Hg||Standard Deviation|Mean
773512|NCT00739674|Secondary|Number of Patients Achieving Target Blood Pressure at Week 40 From Baseline|Number of Patients Achieving Target Blood Pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics) from baseline after 40 weeks of treatment|40 Weeks|463 and 400 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 351 and 331 patients at week 40 for L group and DML group respectively.||Participants|||Number
773539|NCT00739934|Secondary|Cmax Following an IV Loading Dose||Day 1 predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.||μg/mL||Standard Deviation|Geometric Mean
773514|NCT00739674|Secondary|Number of Patients Achieving Target Blood Pressure at Week 6 From Baseline|Number of Patients Achieving Target Blood Pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics) from baseline after 6 weeks of treatment|6 Weeks|463 and 400 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 431 and 383 patients at week 6 for L group and DML group respectively.||Participants|||Number
773515|NCT00739674|Primary|Number of Patients Achieving Target Blood Pressure at Week 14 From Baseline|Number of Patients Achieving Target Blood Pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics) from baseline after 14 weeks of treatment|14 Weeks|463 and 400 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 392 and 357 patients at week 14 for L group and DML group respectively.||Participants|||Number
773516|NCT00739765|Secondary|Hamilton Depression Rating Scale|Continuous scale to measure depressive symptom severity with a potential range from 0 to 74. Higher scores indicate more severe depressive symptoms. Scores <8 are generally considered not depressed; 8-12 mildly depressed; 13-19 moderately depressed; 20 and greater, severely depressed. Reference: Hamilton M: A rating scale for depression. J Neurol Neurosurg Psychiatry 1960;25:56-62|After 14 weeks of treatment|||units on a scale||Standard Deviation|Mean
773517|NCT00739765|Primary|Clinician-Administered PTSD Scale (CAPS)|Continuous measure scale of PTSD symptoms severity. Generally considered state of the art. Range 0-136 (17 items each rated for frequency and for intensity, each on a 0-4 scale). Scores >50 indicate at least moderately severe PTSD; scores <20 were defined as remission. See Blake DD, Weathers FW, Nagy LM, et al: The development of a clinician-administered PTSD scale. J Trauma Stress 1995; 8:75–90; Weathers FW, Keane TM, Davidson JRT: Clinician-Administered PTSD Scale: a review of the first ten years of research. Depression and Anxiety 2001;13:132-156|After 14 weeks of treatment|||units on a scale||Standard Deviation|Mean
773518|NCT00739882|Secondary|Proportion Of Participants Achieving A Physician's Global Assessment (PGA) Rating of Excellent, Or Cleared At Week 12|"The proportion of participants achieving a PGA rating of excellent, or cleared at Week 12.
Cleared = 100% improvement; Excellent = 75-99% improvement"|12 weeks|Due to the termination of the trial, analysis of efficacy-related endpoints was not performed|||||
773519|NCT00739882|Secondary|Proportion Of Participants Achieving A Physician's Global Assessment (PGA) Rating of Good, Excellent, Or Cleared At Week 12|"The proportion of participants achieving a PGA rating of good, excellent, or cleared at Week 12.
Cleared = 100% improvement; Excellent = 75-99% improvement; Good = 50-74% improvement"|12 weeks|Due to the termination of the trial, analysis of efficacy-related endpoints was not performed|||||
773520|NCT00739882|Secondary|Proportion of Participants From the Initial Placebo Group Achieving a PGA – H&F of Rating of Clear, Almost Clear, or Mild From Week 12 to Week 24.|"The proportion of participants achieving a PGA – H&F rating of clear, or almost clear, at Week 24:
Clear - No signs of plaque psoriasis on the hands and/or feet; Almost Clear - Just perceptible erythema and just perceptible scaling on the hands and/or feet; Mild - Light pink erythema with minimal scaling and with or without pustules on the hands and/or feet"|24 weeks|Due to the termination of the trial, analysis of efficacy-related endpoints was not performed|||||
773521|NCT00739882|Secondary|Proportion Of Participants Achieving A Physician's Global Assessment - Hand & Foot (PGA - H&F) Rating Of Clear, Almost Clear Or Mild At Week 24|"The proportion of participants achieving a PGA - H&F rating of clear, almost clear, or mild at Week 24:
Clear - No signs of plaque psoriasis on the hands and/or feet; Almost Clear - Just perceptible erythema and just perceptible scaling on the hands and/or feet; Mild - Light pink erythema with minimal scaling and with or without pustules on the hands and/or feet"|24 weeks|Due to the termination of the trial, analysis of efficacy-related endpoints was not performed|||||
773522|NCT00739882|Secondary|Proportion Of Participants Achieving A Physician's Global Assessment - Hand & Foot (PGA - H&F) Rating Of Clear, Or Almost Clear At Week 12|"The proportion of participants achieving a PGA – H&F rating of clear, or almost clear, at Week 12:
Clear - No signs of plaque psoriasis on the hands and/or feet; Almost Clear - Just perceptible erythema and just perceptible scaling on the hands and/or feet"|12 weeks|Due to the termination of the trial, analysis of efficacy-related endpoints was not performed|||||
773523|NCT00739882|Primary|Proportion Of Participants Achieving A Physician's Global Assessment - Hand & Foot (PGA – H&F) Rating Of Clear, Almost Clear Or Mild At Week 12|"The proportion of subjects achieving a PGA – H&F rating of clear, almost clear, or mild at Week 12:
Clear - No signs of plaque psoriasis on the hands and/or feet; Almost Clear - Just perceptible erythema and just perceptible scaling on the hands and/or feet; Mild - Light pink erythema with minimal scaling and with or without pustules on the hands and/or feet"|12 weeks|Due to the termination of the trial, analysis of efficacy-related endpoints was not performed|||||
773524|NCT00739908|Secondary|Clinical Global Impression - Severity of Illness (CGI-S)|CGI-S measures the study rater's assessment of the severity of depression illness. CGI-S is rated on a scale of 1-7 as follows: 0 = not assessed, 1 = normal, not at all ill, 2 = borderline mentally ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, and 7 = among the most extremely ill patients. CGI-S was measured at randomization and Weeks 1, 2, 4 and 6. Percentage of subjects reported as normal, not at all ill; borderline mentally ill; and mildly ill is reported here at Week 6 or the last available post treatment result (LOCF).|Week 6 or the last available post treatment result (LOCF)|mITT population consisted of all patients with at least one post randomzation MADRS score.||Percentage of Participants|||Number
773525|NCT00739908|Secondary|Clinical Global Impression - Improvement of Illness (CGI-I)|"The Clinical Global Impression - Improvement of Illness (CGI-I) was rated on a 7-point scale by the investigator to measure subject’s total improvement compared to his/her condition at randomization according to the following scale: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. CGI-I was measured at Weeks 1, 2, 4 and 6. Percentage of participants very much improved and much improved at Week 6 or the last available post treatment result (LOCF) is reported here."|Week 6 or the last available post treatment result (LOCF)|mITT population consisted of all patients with at least one post randomzation MADRS score.||Percentage of Participants|||Number
773588|NCT00739999|Secondary|Absolute Change From Baseline in Total Cholesterol (TC)|Total Cholesterol measured in millimoles per liter (mmol/L); assessments were performed in the fasting state (minimum 10-hour fast [optional at Weeks 2 and 6]). Change from baseline = value at observation minus baseline value.|Baseline, Week 2, Week 4, Week 6, Week 8|PD analysis population||mmol/L||Standard Deviation|Mean
773526|NCT00739908|Secondary|Inventory of Depressive Symptomatology 30 Item -Self Report (IDS -SR 30 Items)|IDSR-SR 30 measures the severity of depressive symptoms by subjects. This scale has 30 items. The minimum score is 0 and the maximum possible IDS-30 score is 90 (the highest severity). IDS-SR30 was administered at screening, randomization and Weeks 1, 2, 4, and 6. Change from randomization in the IDS-SR30 total score at Week 6 or the last available post treatment result (LOCF) is reported here.|Randomization and Week 6 or the last available post treatment result (LOCF)|mITT population consisted of all patients with at least one post randomzation MADRS score.||units on a scale||95% Confidence Interval|Least Squares Mean
773527|NCT00739908|Secondary|The Hospital Anxiety and Depression Scale (HADS)|HADS is a subject-rated questionnaire designed to detect states of anxiety and depression. The HADS consists of 14 questions relating to anxiety or depression, each with a choice of four responses [Zigmond, 1983]. These responses are numerically scored 0-3, with 0 representing the least severe response and 3 representing the most severe response. The highest possible total score is 42. HADS was assessed at randomization and Weeks 1, 2, 4, and 6 of the study. Change from randomization in the HADS total score at Week 6 or the last available post treatment result (LOCF) is reported here.|Randomization and Week 6 or the last available post treatment result (LOCF)|mITT population consisted of all patients with at least one post randomzation MADRS score.||units on a scale||95% Confidence Interval|Least Squares Mean
773528|NCT00739908|Secondary|Montgomery and Asberg Depression Rating Scale (MADRS) Remitter Rate|Percentage of participants with total MADRS score of 11 or less. MADRS was assessed at randomization and Weeks 1, 2, 4, and 6 of the study. MADRS Remitter rate at Week 6 or the last available post treatment result (LOCF)is reported here.|Week 6 or the last available post treatment result (LOCF)|mITT population consisted of all patients with at least one post randomzation MADRS score.||Percentage of Participants||95% Confidence Interval|Number
773529|NCT00739908|Secondary|Montgomery and Asberg Depression Rating Scale (MADRS) Response Rate|MADRS is a 10-item checklist designed to measure the overall severity of depressive symptoms in patients with MDD [Montgomery, 1979]. Items are rated on a scale of 0-6, with scores ranging from 0 to 60 with 0 being symptom free and 60 being the most severe depression. Percentage of participants who achieved a reduction in total MADRS score of at least 50% or more as compared to baseline. MADRS was assessed at randomization and Weeks 1, 2, 4, and 6 of the study. MADRS Responder rate at Week 6 or the last available post treatment result (LOCF) is reported here.|Week 6 or the last available post treatment result (LOCF)|mITT population consisted of all patients with at least one post randomization MADRS score.||percentage of participants||95% Confidence Interval|Number
773530|NCT00739908|Primary|Change From Randomization in Montgomery and Asberg Depression Rating Scale (MADRS)|The Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item checklist designed to measure the overall severity of depressive symptoms in patients with MDD [Montgomery, 1979]. Items are rated on a scale of 0-6, with scores ranging from 0 to 60 with 0 being symptom free and 60 being the most severe depression. MADRS was assessed at randomization and Weeks 1, 2, 4 and 6 of the study.|Randomization and study end (Week 6).|mITT population consisted of all patients with at least one post randomzation MADRS score. The primary efficacy variable was the change-from-randomization to each available post-randomization measurement of the MADRS total score, used as the response variable in a mixed model repeated measures (MMRM) analysis.||units on a scale||95% Confidence Interval|Least Squares Mean
773531|NCT00739934|Secondary|Tmax of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration||Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.||hours||Full Range|Median
773532|NCT00739934|Secondary|Cmax,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration||Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.||μg/mL||Standard Deviation|Geometric Mean
773533|NCT00739934|Secondary|AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration|AUC12,ss = Area under the plasma concentration-time profile from time zero (predose) to twelve hours at steady-state. AUC12,ss was obtained by the Linear/Log trapezoidal method.|Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.||μg*h/mL||Standard Deviation|Geometric Mean
773534|NCT00739934|Secondary|Tmax of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration|Zero Tmax refers to the highest concentration observed for one participant at predose. The profile of the metabolite is relatively flat, which could result in slight variation in sample collection or assay process.|Days 1 and 7 (up to Day 20 or more) predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N=number of participants with analyzable data.||hours||Full Range|Median
773535|NCT00739934|Secondary|Cmax,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration||Days 1 and 7 (up to Day 20 or more) predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.||μg/mL||Standard Deviation|Geometric Mean
773536|NCT00739934|Secondary|AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration|AUC12,ss = Area under the plasma concentration-time profile from time zero (predose) to twelve hours at steady-state. AUC12,ss was obtained by the Linear/Log trapezoidal method.|Days 1 and 7 (up to Day 20 or more) predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.||μg*h/mL||Standard Deviation|Geometric Mean
773537|NCT00739934|Secondary|Trough Concentrations (Cmin)||Day 7 (up to Day 20 or more) for IV; Day 7 (or later) for oral at predose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data; n = number of participants who contributed to data.||μg/mL||Standard Deviation|Geometric Mean
773538|NCT00739934|Secondary|Tmax Following an IV Loading Dose||Day 1 predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.||hours||Full Range|Median
773624|NCT00740714|Secondary|Adverse Experiences: Insomnia|Number of participants with insomnia|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.||participants|||Number
773540|NCT00739934|Secondary|AUC12 Following IV Loading Dose|AUC12 = Area under the plasma concentration-time profile from time zero (predose) to twelve hours. AUC12 was obtained by the Linear/Log trapezoidal method.|Day 1 predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.||μg*h/mL||Standard Deviation|Geometric Mean
773541|NCT00739934|Primary|Tmax Following Oral Administration||Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.||hours||Full Range|Median
773542|NCT00739934|Primary|Cmax,ss Following Oral Administration||Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.||μg/mL||Standard Deviation|Geometric Mean
773543|NCT00739934|Primary|AUC12,ss Following Oral Administration|AUC12,ss = Area under the plasma concentration-time profile from time zero (predose) to twelve hours at steady-state. AUC12,ss was obtained by the Linear/Log trapezoidal method.|Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.||μg*h/mL||Standard Deviation|Geometric Mean
773544|NCT00739934|Primary|Time to Reach Cmax (Tmax) Following IV Administration||Day 7 (up to Day 20 or more) at predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.||hours||Full Range|Median
773545|NCT00739934|Primary|Peak Plasma Concentration at Steady State (Cmax,ss) Following IV Administration||Day 7 (up to Day 20 or more) at predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.||μg/mL||Standard Deviation|Geometric Mean
773546|NCT00739934|Primary|Area Under the Curve Over Dosing Interval at Steady State (AUC12,ss) Following IV Administration|AUC12,ss = Area under the plasma concentration-time profile from time zero (predose) to twelve hours at steady-state. AUC12,ss was obtained by the Linear/Log trapezoidal method.|Day 7 (up to Day 20 or more) at predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose|Intent-to treat (ITT) population of participants who had completed pharmacokinetic (PK) blood sampling for at least one day. N = number of participants with analyzable data.||μg*h/mL||Standard Deviation|Geometric Mean
773547|NCT00739973|Secondary|Percentage of Patients Achieving a Successful Systolic Blood Pressure Response|Blood pressure response in msSBP is defined as a mean sitting systolic blood pressure < 140 mmHg or a >= 20 mmHg reduction from baseline. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|End of study (Week 8)|All patients who were randomized. Following the intent-to-treat principle, patients will be analyzed according to the treatment they were assigned to at randomization. Patients with baseline and Endpoint msDBP values were included in this analysis.||Percentage of Participants|||Number
773548|NCT00739973|Secondary|Percentage of Patients Achieving a Successful Diastolic Blood Pressure Response|Blood pressure response in msDBP is defined as a mean sitting diastolic blood pressure < 90 mmHg or a >=10 mmHg reduction from baseline. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|End of study (Week 8)|All patients who were randomized. Following the intent-to-treat principle, patients will be analyzed according to the treatment they were assigned to at randomization. Patients with baseline and Endpoint msDBP values were included in this analysis.||Percentage of Participants|||Number
773549|NCT00739973|Secondary|Percentage of Patients With Blood Pressure Control (msSBP < 140 mm Hg and msDBP < 90 mm Hg) at End of Study|Blood pressure control defined as msSBP < 140 mm Hg and msDBP < 90 mm Hg. The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|End of study (Week 8)|All patients who were randomized. Following the intent-to-treat principle, patients will be analyzed according to the treatment they were assigned to at randomization. Patients with baseline and Endpoint msDBP values were included in this analysis.||Percentage of Participants|||Number
773550|NCT00739973|Secondary|Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Placebo on Change in Mean Sitting Systolic Blood Pressure (msSBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.||mm Hg||Standard Error|Least Squares Mean
773584|NCT00739999|Secondary|Absolute Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C)|Change from baseline in high-density lipoprotein cholesterol measured in millimoles per liter (mmol/L); assessments were performed in the fasting state (minimum 10-hour fast [optional at Weeks 2 and 6]). Change from baseline = value at observation minus baseline value.|Baseline, Week 2, Week 4, Week 6, Week 8|PD analysis population||mmol/L||Standard Deviation|Mean
773625|NCT00740714|Secondary|Adverse Experiences: Constipation|Number of participants with constipation|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.||participants|||Number
773551|NCT00739973|Secondary|Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Amlodipine 10 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.||mm Hg||Standard Error|Least Squares Mean
773552|NCT00739973|Secondary|Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Aliskiren 300 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.||mm Hg||Standard Error|Least Squares Mean
773553|NCT00739973|Secondary|Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Placebo on Change in Mean Sitting Systolic Blood Pressure (msSBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.||mm Hg||Standard Error|Least Squares Mean
773554|NCT00739973|Secondary|Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.||mm Hg||Standard Error|Least Squares Mean
773555|NCT00739973|Secondary|Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Aliskiren 300 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.||mm Hg||Standard Error|Least Squares Mean
773556|NCT00739973|Secondary|Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Placebo on Change in Mean Sitting Systolic Blood Pressure (msSBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.||mm Hg||Standard Error|Least Squares Mean
773557|NCT00739973|Secondary|Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Amlodipine 10 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All randomized patients who received the study medication.||mm Hg||Standard Error|Least Squares Mean
773585|NCT00739999|Secondary|Percent Change From Baseline in Triglycerides (TG)|Triglycerides (TG): percent (%) change from baseline by treatment over time = [TG at observation minus TG at Week 0] divided by TG at Week 0 * 100. Assessments were performed in the fasting state (minimum 10-hour fast [optional at Weeks 2 and 6]).|Baseline, Week 2, Week 4, Week 6, Week 8|PD analysis population||percent change in TG||Standard Deviation|Mean
773626|NCT00740714|Secondary|Adverse Experiences: Back Pain|Number of participants with back pain|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.||participants|||Number
773558|NCT00739973|Primary|Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Placebo on Change in Mean Sitting Diastolic Blood Pressure (msDBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.||mm Hg||Standard Error|Least Squares Mean
773559|NCT00739973|Primary|Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Amlodipine 10 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.||mm Hg||Standard Error|Least Squares Mean
773560|NCT00739973|Primary|Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Aliskiren 300 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.||mm Hg||Standard Error|Least Squares Mean
773561|NCT00739973|Primary|Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Placebo on Change in Mean Sitting Diastolic Blood Pressure (msDBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.||mm Hg||Standard Error|Least Squares Mean
773562|NCT00739973|Primary|Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.||mm Hg||Standard Error|Least Squares Mean
773563|NCT00739973|Primary|Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Aliskiren 300 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.||mm Hg||Standard Error|Least Squares Mean
773564|NCT00739973|Primary|Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Placebo on Change in Mean Sitting Diastolic Blood Pressure (msDBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.||mm Hg||Standard Error|Least Squares Mean
773586|NCT00739999|Secondary|Absolute Change From Baseline in Triglycerides (TG)|Change from baseline in triglycerides measured in millimoles per liter (mmol/L); assessments were performed in the fasting state (minimum 10-hour fast [optional at Weeks 2 and 6]). Change from baseline = value at observation minus baseline value.|Baseline, Week 2, Week 4, Week 6, Week 8|PD analysis population||mmol/L||Standard Deviation|Mean
773565|NCT00739973|Primary|Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Amlodipine 10 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.||mm Hg||Standard Error|Least Squares Mean
773566|NCT00739973|Primary|Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Aliskiren 150 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.||mm Hg||Standard Error|Least Squares Mean
773567|NCT00739973|Primary|Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Placebo on Change in Mean Sitting Diastolic Blood Pressure (msDBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.||mm Hg||Standard Error|Least Squares Mean
773568|NCT00739973|Primary|Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.||mm Hg||Standard Error|Least Squares Mean
773569|NCT00739973|Primary|Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Aliskiren 150 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.||mm Hg||Standard Error|Least Squares Mean
773570|NCT00739973|Secondary|Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Aliskiren 150 mg on Change in Mean Sitting Systolic Blood Pressure (mssBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.||mm Hg||Standard Error|Least Squares Mean
773571|NCT00739973|Secondary|Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Placebo on Change in Mean Sitting Systolic Blood Pressure (msSBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.||mm Hg||Standard Error|Least Squares Mean
773587|NCT00739999|Secondary|Percent Change From Baseline in Total Cholesterol (TC)|Total cholesterol (TC): percent (%) change from baseline by treatment over time = [TC at observation minus TC at Week 0] divided by TC at Week 0 * 100. Assessments were performed in the fasting state (minimum 10-hour fast [optional at Weeks 2 and 6]).|Baseline, Week 2, Week 4, Week 6, Week 8|PD analysis population||percent change in TC||Standard Deviation|Mean
773572|NCT00739973|Secondary|Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.||mm Hg||Standard Error|Least Squares Mean
773573|NCT00739973|Secondary|Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Aliskiren 150 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.||mm Hg||Standard Error|Least Squares Mean
773574|NCT00739999|Primary|Parent-metabolite Population Pharmacokinetic (PK) Model for Atorvastatin and Its Metabolites: Apparent Volume of Distribution of the Central Compartment (Vc/F)|Parent-metabolite population PK model built using sparse blood samples from Tanner Stages 1 and 2+. Sampling times: Weeks 2 + 6: single sample between 4 -12 hours postdose; Weeks 4 + 8: predose, 1 + 2 hours postdose. Plasma samples analyzed for atorvastatin and active hydroxyacid metabolite (o-hydroxyatorvastatin) concentrations using validated, sensitive, specific high-performance liquid chromatography tandem mass spectrometric method. Vc/F value based on 70 kg body weight. Parameter estimation uncertainty (95% CI) by non-parametric bootstrap analysis. Data presented are result of model used.|Week 2, Week 4, Week 6, Week 8|Pharmacokinetic (PK) concentration population: all enrolled and treated subjects who had ≥ 1 PK concentration assessed. Active hydroxyacid metabolite p-hydroxyatorvastatin was not included in the model as originally planned as > 80% of samples were below detectable level at the doses used in this trial.||liters||95% Confidence Interval|Number
773575|NCT00739999|Secondary|Percent Change From Baseline in Flow-Mediated Dilatation at Week 8|Brachial Flow-Mediated Dilatation (FMD) = (max minus baseline diameter divided by baseline diameter) x 100%.|Baseline, Week 8|PD analysis population. Flow-mediated dilation (FMD) was measured at centers with established FMD facilities.||percent change in FMD||Standard Deviation|Mean
773576|NCT00739999|Secondary|Absolute Change From Baseline in Flow-Mediated Dilatation at Week 8|Brachial artery flow-mediated dilatation (FMD) = (max minus baseline diameter divided by baseline diameter) x 100%. Standardized image acquisition: brachial artery images recorded for one minute at rest, blood pressure cuff inflated to 250 mm Hg for 5 minutes with brachial artery imaged continuously throughout cuff inflation, cuff released to produce reactive hyperaemia and the brachial artery imaged continuously for 3 minutes after release. Total duration of measurement approximately 25 minutes. Change from baseline = value at observation minus baseline value.|Baseline, Week 8|PD analysis population. Flow-mediated dilation (FMD) was measured at centers with established FMD facilities.||FMD||Standard Deviation|Mean
773577|NCT00739999|Secondary|Percent Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C)|Very low-density lipoprotein-cholesterol (VLDL-C): percent (%) change from baseline by treatment over time = [VLDL-C at observation minus VLDL-C at Week 0] divided by VLDL-C at Week 0 * 100. Assessments were performed in the fasting state (minimum 10-hour fast [optional at Weeks 2 and 6]).|Baseline, Week 2, Week 4, Week 6, Week 8|PD analysis population||percent change in VLDL-C||Standard Deviation|Mean
773578|NCT00739999|Secondary|Absolute Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C)|Change from baseline in very low-density lipoprotein-cholesterol (VLDL-C) measured in millimoles per liter (mmol/L). Change from baseline = value at observation minus baseline value. Assessments were performed in the fasting state (minimum 10-hour fast [optional at Weeks 2 and 6]).|Baseline, Week 2, Week 4, Week 6, Week 8|PD analysis population||mmol/L||Standard Deviation|Mean
773579|NCT00739999|Secondary|Percent Change From Baseline in Apolipoprotein B (Apo B)|Apolipoprotein B (Apo B): percent (%) change from baseline by treatment over time = [Apo B at observation minus Apo B at Week 0] divided by Apo B at Week 0 * 100. Assessments were performed in the fasting state (minimum 10-hour fast [optional at Weeks 2 and 6]).|Baseline, Week 2, Week 4, Week 6, Week 8|PD analysis population||percent change in Apo B||Standard Deviation|Mean
773580|NCT00739999|Secondary|Absolute Change From Baseline in Apolipoprotein B (Apo B)|Change from baseline in Apolipoprotein B measured in grams per liter (g/L); assessments were performed in the fasting state (minimum 10-hour fast [optional at Weeks 2 and 6]). Change from baseline = value at observation minus baseline value.|Baseline, Week 2, Week 4, Week 6, Week 8|PD analysis population||g/L||Standard Deviation|Mean
773581|NCT00739999|Secondary|Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1)|Apolipoprotein A-1 (Apo A-1): percent (%) change from baseline by treatment over time = [Apo A-1 at observation minus Apo A-1 at Week 0] divided by Apo A-1 at Week 0 * 100. Assessments were performed in the fasting state (minimum 10-hour fast [optional at Weeks 2 and 6]).|Baseline, Week 2, Week 4, Week 6, Week 8|PD analysis population||percent change in Apo A-1||Standard Deviation|Mean
773582|NCT00739999|Secondary|Absolute Change From Baseline in Apolipoprotein A-1 (Apo A-1)|Change from baseline in Apolipoprotein A-1 measured in grams per liter (g/L); assessments were performed in the fasting state (minimum 10-hour fast [optional at Weeks 2 and 6]). Change from baseline = value at observation minus baseline value.|Baseline, Week 2, Week 4, Week 6, Week 8|PD analysis population||g/L||Standard Deviation|Mean
773583|NCT00739999|Secondary|Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C)|High-density lipoprotein cholesterol (HDL-C): percent (%) change by treatment over time = [HDL-C at observation minus HDL-C at Week 0] divided by HDL-C at Week 0 * 100. Assessments were performed in the fasting state (minimum 10-hour fast [optional at Weeks 2 and 6]).|Baseline, Week 2, Week 4, Week 6, Week 8|PD analysis population||percent change in HDL-C||Standard Deviation|Mean
773589|NCT00739999|Secondary|Percent Change From Baseline in Pharmacodynamic Responses of Low-density Lipoprotein Cholesterol (LDL-C)|Low-density Lipoprotein Cholesterol (LDL-C): percent (%) change from baseline by treatment over time = [LDL-C at observation minus LDL-C at Week 0] divided by LDL-C at Week 0 * 100. Assessments were performed in the fasting state (minimum 10-hour fast [optional at Weeks 2 and 6]).|Baseline, Week 2, Week 4, Week 6, Week 8|PD analysis population||percent change in LDL-C||Standard Deviation|Mean
773590|NCT00739999|Secondary|Absolute Change From Baseline in Pharmacodynamic Responses of Low-density Lipoprotein Cholesterol (LDL-C)|Low-density lipoprotein cholesterol (LDL-C) measured in millimoles per liter (mmol/L); assessments were performed in the fasting state (minimum 10-hour fast [optional at Weeks 2 and 6]). Change from baseline = value at observation minus baseline value.|Baseline, Week 2, Week 4, Week 6, Week 8|Pharmacodynamic (PD) analysis population: all enrolled subjects who received ≥ 1 dose of study drug and had ≥ 1 PD parameter measurement.||mmol/L||Standard Deviation|Mean
773591|NCT00739999|Primary|Parent-metabolite Population Pharmacokinetic (PK) Model for Atorvastatin and Its Metabolites: Atorvastatin Apparent Clearance (CL/F)|Parent-metabolite population PK model built using sparse blood samples from both Tanner Stage 1 and Tanner Stage 2+. Blood sampling times: Weeks 2 and 6: single sample between 4 and 12 hours postdose; Weeks 4 and 8: predose, 1 hour, and 2 hours postdose. Plasma samples were analyzed for atorvastatin and active hydroxyacid metabolite (o-hydroxyatorvastatin) concentrations using a validated, sensitive, and specific high-performance liquid chromatography tandem mass spectrometric method. Data presented are the result of the model used.|Week 2, Week 4, Week 6, Week 8|Pharmacokinetic (PK) concentration population: all enrolled and treated subjects who had ≥ 1 PK concentration assessed. Active hydroxyacid metabolite p-hydroxyatorvastatin was not included in the model as originally planned as > 80% of samples were below detectable level at the doses used in this trial.||L/hr|||Number
773592|NCT00740051|Secondary|The Change in FPG From Baseline by Visit Over Time|This change from baseline reflects the FPG (at weeks 6, 12, 18, 22, 26, 30, 34, 40, 46, 52) minus the Week 0 FPG.|Baseline and weeks 6,12,18, 22, 26, 30, 34, 40, 46, 52|Treated set (OC)||mg/dL||Standard Deviation|Mean
773593|NCT00740051|Secondary|The Change in HbA1c From Baseline by Visit Over Time|HbA1c is measured as a percentage. Thus, this change from baseline reflects the HbA1c percent (at weeks 6, 12, 18, 22, 26, 30, 34, 40, 46, 52) minus the Week 0 HbA1c percent.|Baseline and weeks 6,12, 18, 22, 26, 30, 34, 40, 46, 52|Treated set (OC)||percent||Standard Deviation|Mean
773594|NCT00740051|Secondary|Percentage of Patients With HbA1c Lowering by 0.5% at Week 18 (Interim Analysis)|Odds ratios are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance.|Week 18|The Full Analysis Set (FAS) included all treated patients with a baseline and at least one on-treatment HbA1c measurement available during the first phase of the study. Patients without a value at week 18 were analysed as non-responders.||percent of patients|||Number
773595|NCT00740051|Secondary|Percentage of Patients With HbA1c<6.5 at Week 18 (Interim Analysis)|Odds ratios are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance.|Week 18|FAS patients with baseline HbA1c >= 6.5%. Patients without a value at Week 18 were analysed as non-responders.||percent of patients|||Number
773596|NCT00740051|Secondary|Percentage of Patients With HbA1c<7.0 at Week 18 (Interim Analysis)|Odds ratios are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance.|Week 18|Full Analysis Set (FAS) patients with baseline HbA1c >= 7.0%. Patients without a value at week 18 were analysed as non-responders.||percent of patients|||Number
773597|NCT00740051|Secondary|Fasting Plasma Glucose (FPG) Change From Baseline at Week 18 (Interim Analysis)|This change from baseline reflects the Week 18 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG, baseline HbA1c, prior OADs and reason for metformin intolerance (Interim Analysis).|Baseline and week 18|All patients in FAS with values for FPG at baseline and at week 18. Last Observation Carried Forward (LOCF) was used as the imputation rule (Interim Analysis).||mg/dl||Standard Error|Mean
773598|NCT00740051|Primary|HbA1c Change From Baseline at Week 18 (Final Analysis)|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance. HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance. The primary analysis was re-run at the completion of the study in the final study report.|Baseline and week 18|The Full Analysis Set (FAS) included all treated patients with a baseline and at least one on-treatment HbA1c measurement available during the first phase of the study. Last observation carried forward (LOCF) was used as the imputation rule.||percent||Standard Error|Mean
773599|NCT00740051|Primary|HbA1c Change From Baseline at Week 18 (Interim Analysis)|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance.|Baseline and week 18|The Full Analysis Set (FAS) included all treated patients with a baseline and at least one on-treatment HbA1c measurement available during the first phase of the study. Last Observation Carried Forward (LOCF) was used as the imputation rule.||percent||Standard Error|Mean
773600|NCT00740181|Primary|Response Rate|"Complete Response/Complete Remission:
Complete remission (CR) is defined as the presence of all of the following:
Peripheral blood - No leukemic blasts present.
No extramedullary findings of leukemia or disappearance of such (i.e. CNS or soft tissue involvement)
Bone marrow
No Auer rods
Less than 5% blast cells.
CBC and bone marrow criteria must be met within one week of each other.
Hemoglobin 9g/dl or greater
Neutrophil count >1000 and platelet count >100,000.
RBC Transfusion free for 2 weeks."|within 30 days of last treatment|||participants|||Number
773601|NCT00740207|Secondary|The Number of Participants Requiring Repeat Injection(s) Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA.|The Investigator assessed the images and recorded the number of repeat power injections required due to motion artifacts for each participant.|Immediately postdose|||Participants|||Number
773602|NCT00740207|Secondary|The Number of Participants With Motion Artifacts Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA.|Using the following 5-point scale, the Investigator reviewed the images for motion artifact in vessels distal to the knee: 0 = None; 1 = Mild, not significant; 2 = Significant, but correctable; 3 = Degrades image quality; 4 = Images uninterpretable.|Immediately postdose|Patients who did not deviate from the planned protocol.||Participants|||Number
773603|NCT00740207|Primary|Level of Pain in the Lower Extremities Scored by the Participants on the Visual Analog Scale Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA.|Visual Analog Scale: Patients were asked to mark on a 10 centimeter line where their pain was in the lower extremity of interest, in relation to the 2 extremes: no pain (0) on the far left and worst pain (10) on the far right. Pain Severity Scale: (0) None = VAS Score 0; (1) Mild = VAS Score 1-3; (2) Moderate = VAS Score 4-6; (3) Severe = VAS Score 7-10. Patients were assessed immediately prior to injection and again immediately following injection.|Immediately prior to power injection run and again immediately following power injection run|Patients who did not deviate from the planned protocol.||Participants|||Number
773604|NCT00740220|Primary|Kappa Statistic for Correlation of the Oxygen Saturation Across 3 Serial 6 Minute Walk Tests (6MWT)|The kappa statistic is a measure of the quality of a test. It is a ratio.|All three 6MWTs should take place within 30 days|||Ratio|||Number
773605|NCT00740480|Secondary|Tissue Reaction to Implant|None - no edema, erythema or purulence around the area of the staples Mild - slight erythema and/or edema in the region of one or more staple, limited to not greater than 2 mm from the staple Moderate - erythema and/or edema in the region of one or more staples, greater than 2 mm extension from the staples Severe - Generalized edema and/or erythema of the septum, or purulence and/or granulation tissue involved in one or more staples.|One week post surgery|ITT||participants|||Number
773606|NCT00740480|Primary|Coaptation (Tissue Approximation)|Complete tissue approximation at one week.|One week post surgery|ITT||participants|||Number
773607|NCT00740584|Secondary|Incidence of Adverse Experiences||Approximately 13 weeks||||||
773608|NCT00740584|Primary|HIV Antiviral Activity of Each of the Cervico-vaginal Samples (Samples Taken From the Vagina Using the Softcup)|"The HIV antiviral activity is the ability of each sample taken from the vagina (cervico-vaginal (CV) sample) to inhibit HIV virus from infecting a specific cell culture.
The inhibition of HIV in the presence of the CV sample is compared to the inhibition of HIV in the cell culture with no CV sample added. This allows an assessment of the affect that the CV sample has."|at 3 hours|||percent anti-viral activity||Inter-Quartile Range|Median
773609|NCT00740597|Primary|Wound Complication Rate|"Major wound complications up to 4 months post surgery include:
Complications requiring a secondary operation under general or regional anesthesia for wound care.
Seroma aspiration. Drain placement. Minor wound debridement and wound care. Readmission for wound care such as intravenous antibiotics. Persistent wound deep packing or wound vacuum assisted closure for greater than 120 days."|1 year|The one patient accrued to the study stopped treatment prior to completing treatment due to insurance denial.|||||
773610|NCT00740636|Primary|The Objective Overall Response|"The objective response is defined as all complete responses and partial responses based on the modified RECIST.Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started."|2 years|||participants|||Number
773611|NCT00740714|Secondary|Adverse Experiences: Insomnia: Moderate/Severe|Number of participants with moderate/severe insomnia|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.||participants|||Number
773612|NCT00740714|Secondary|Adverse Experiences: Back Pain: Moderate/Severe|Number of participants with moderate/severe back pain|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.||participants|||Number
773613|NCT00740714|Secondary|Adverse Experiences: Anxiety: Moderate/Severe|Number of participants with moderate/severe anxiety|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.||participants|||Number
773614|NCT00740714|Secondary|Adverse Experiences: Constipation: Moderate/Severe|Number of participants with moderate/severe constipation|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.||participants|||Number
773615|NCT00740714|Secondary|Adverse Experiences: Depression|Number of participants with depression|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.||participants|||Number
773616|NCT00740714|Secondary|Adverse Experiences: Hypertension|Number of participants with hypertension|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.||participants|||Number
773617|NCT00740714|Secondary|Adverse Experiences: Nausea|Number of participants with nausea|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.||participants|||Number
773618|NCT00740714|Secondary|Adverse Experiences: Urinary Tract Infection|Number of patients with urinary tract infections|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.||participants|||Number
773619|NCT00740714|Secondary|Adverse Experiences: Headache|Number of participants with headache|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.||participants|||Number
773620|NCT00740714|Secondary|Adverse Experiences: Diarrhoea|Number of participants with diarrhoea|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.||participants|||Number
773621|NCT00740714|Secondary|Adverse Experiences: Nasopharyngitis|Number of participants with nasopharyngitis|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.||participants|||Number
773622|NCT00740714|Secondary|Adverse Experiences: Tremor|Number of participants with tremor|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.||participants|||Number
773623|NCT00740714|Secondary|Adverse Experiences: Anxiety|Number of participants with anxiety|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.||participants|||Number
773627|NCT00740714|Secondary|CoQ10 Levels in Plasma|Based on samples analyzed to date|Baseline, 1, 8 and 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first|All participants have been included and data is based on samples analyzed to date.||ug/ml||Standard Deviation|Mean
773628|NCT00740714|Secondary|Change in Hoehn & Yahr Score From Baseline to 16 Months|The Modified Hoehn and Yahr Scale is an 8-level Parkinson disease staging instrument. The investigator will assess disease stage at each level. The disease stages range from the best outcome of 0 (no signs of disease) to the worst outcome of 5 (wheelchair bound or bedridden unless aided).|Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first|All participants were used in primary and secondary outcome analyses.||units on a scale||Standard Error|Least Squares Mean
773629|NCT00740714|Secondary|Change in Symbol Digit Modalities Test From Baseline to 16 Months|The Symbol Digit Modalities Test screens cognitive impairment by using a simple substitution tasks that individuals with normal functioning can easily perform. The test score range is from 0(worst outcome) to 110 (best outcome).|Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first|All participants were used in primary and secondary outcome analyses.||units on a scale||Standard Error|Least Squares Mean
773630|NCT00740714|Secondary|Change in PD Quality of Life Scale From Baseline to 16 Months|The subject will complete a questionnaire that will evaluate how Parkinson disease has affected their health and overall quality of life at each visit. The total quality of life scale measures a total of 33 aspects of quality of life. Each aspect is rated on scale of 0 (best outcome) to 4 (worst outcome). Total score range is 0-132. A higher score or increased score compared to a previous visit indicates a lowered quality of life.|Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first|All participants were used in primary and secondary outcome analyses.||units on a scale||Standard Error|Least Squares Mean
773631|NCT00740714|Secondary|Change in Modified Rankin Scale From Baseline to 16 Months|The Modified Rankin Scale is a global functional health index with a strong accent on physical disability. Subjects are scored on a scale of 0 (no symptoms at all) to 5 (severe disability: bedridden incontinent, and requiring constant nursing care and attention.|Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first|All participants were used in primary and secondary outcome analyses.||units on a scale||Standard Error|Least Squares Mean
773632|NCT00740714|Secondary|Change in Modified Schwab & England Independence Scale From Baseline to 16 Months|This scale measures activities of daily living. This is an investigator and subject assessment of the subject's level of independence at all scheduled visits. The subject is scored on a percentage scale reflective of his/her ability to perform acts of daily living in relation to pre-Parkinson disease ability. Scores range in increments of 10%: 100% for normal (subject is completely independent; essentially normal) to 0% (vegetative functions such as swallowing, bladder and bowel functions are not functioning; bedridden).|Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first|All participants were used in primary and secondary outcome analyses.||units on a scale||Standard Error|Least Squares Mean
773633|NCT00740714|Primary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) (Total Score (Sum of Parts I, II and III Ranges From 0 to 176))|Outcome is defined as change in total Unified Parkinson's Disease Rating Scale (UPDRS) between the baseline visit and month 16 or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first. The UPDRS score has three components, each consisting of questions answered on a 0-4 point scale. Part I assesses mentation, behavior and mood; Part II assesses activities of daily living in the week prior to the designated visit; and Part III assesses motor abilities at the time of the visit. A total of 31 items are included in Parts I, II and III. Each item will receive a score ranging from 0 to 4 where 0 represents the absence of impairment and 4 represents the highest degree of impairment. Total score ranges from 0-176.|Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first|Eligible research participants were assigned by randomization to one of three treatment groups: CoQ10 2400 mg/day, CoQ10 1200 mg/day or matching placebo. All participants also received 1200 IU of vitamin E daily.||units on a scale||Standard Error|Least Squares Mean
773634|NCT00740727|Secondary|Number of Participants With Pain at EASI Infusion Site, on Next-day Follow-up|"Assessment during upon next-day follow-up, for pain as assessed with 10-point scale (0=no pain; 10=worst pain). Significant pain was defined a priori as a pain score of at least 3.
Presence of any pain (yes or no question and then numeric rating if pain was present) was assessed upon follow-up by telephone; on this follow-up a yes/no question was also asked about any complications at infusion site (in the upper back)."|2 days|Participants received EASI access placement, with co-administration of human recombinant hyaluronidase.||Participants|||Number
773635|NCT00740727|Secondary|Number of Participants With Pain During EASI Infusion|Assessment during EASI placement & initial infusion, for pain as assessed with 10-point scale (0=no pain; 10=worst pain). Significant pain was defined a priori as a pain score of at least 3.|1 day|Participants received EASI access placement, with co-administration of human recombinant hyaluronidase.||Participants|||Number
773636|NCT00740727|Primary|Systemic Absorption of Subcutaneously Administered Tracer-labelled Glucose|Number of subjects (out of a possible 18) in whom EASI-administered tracer-labeled glucose was absorbed systemically.Gas chromatography/Mass spectrometry analysis was performed on timed phlebotomy samples, to assess for tracer-labeled glucose.Isotopic glucose enrichment was determined by plasma analysis on a Hewlett-Packard 5985B quadruple mass spectrometer, using + chemical ionization (methane reagent gas). A 12m×0.20mm ID, OV-1 capillary column (He carrier) was used in the gas chromatograph.Enrichments of glucose were calculated as atom percent excess relative to natural background level.|1 day|Participants received EASI access placement, with co-administration of human recombinant hyaluronidase.||Participants|||Number
773637|NCT00740727|Primary|Number of Participants With Successfully Placed EASI Lines|"Ability of Basic Life Support (BLS) providers to place EASI access lines.
The unit of analysis is the 18 BLS participants (these were also the 18 individuals in whom the EASI access lines were placed)."|1 day|Participants received EASI access placement, with co-administration of human recombinant hyaluronidase.||Participants|||Number
786192|NCT00833690|Primary|Safety|Defined as absence of serious adverse experiences (SAEs) that warranted terminating an inosine treatment arm or the trial, as determined by the Data and Safety Monitoring Committee.|24 months|||Events|||Number
773638|NCT00740779|Primary|National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Total Score.|Change from baseline In NIH-CPSI at Week 12. Three separate domain scores are calculated as pain, urinary symptoms, and quality of life impact. NIH-CPSI total score uses a 0 to 43 scale; 0 best, 43 worse symptoms.|12 weeks|The number of participants for analysis is determined by Last Observation Carried Forward (LOCF).||Units on a 0 to 43 scale||Standard Deviation|Mean
773639|NCT00740792|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)|adult Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scored at day 1(baseline) and at day 14.The scale is measured from a value of 0 to 24. A negative number corresponds to a change from baseline measurement. An increased negative number is suggestive of improvement.|day 1 to day 14|Intent to Treat (ITT) population (18 yrs of age and older) who have had one post baseline efficacy observation||units on a scale||Standard Deviation|Least Squares Mean
773640|NCT00740792|Secondary|Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (iTNSS)|"change from baseline in 12-hour instantaneous ( how do you feel now) total nasal symptom score (iTNSS)consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary cards for the entire 14 day study period.
The measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value.A greater negative value is suggestive of improvement."|day 1 to14|Intent to Treat (ITT)population includes all subjects who were randomized and had at least one post baseline efficacy observation.||units on a scale||Standard Deviation|Least Squares Mean
773641|NCT00740792|Primary|Change From Baseline in 12 Hour Reflective Total Nasal Symptom Score (rTNSS)|"change from baseline in 12-hour reflective(how you felt over the previous 12 hours) total nasal symptom score (rTNSS)consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary cards for the entire 14 day study period.
The measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value.A greater negative score is suggestive of improvement."|day1 to 14 days|Intent-to-Treat(ITT) population includes all subjects who were randomized and had at least one post baseline efficacy observation||units on a scale||Standard Deviation|Least Squares Mean
773642|NCT00740831|Primary|Co-primary Safety Endpoint: % of Subjects Reporting Moderate or Severe Hot Flushes as Adverse Events Throughout the Treatment Period for PGL4001 Compared With GnRH-agonist|"Difference in percentage of subjects reporting moderate or severe hot flushes:
Frequency and severity of this adverse event(as spontaneously reported by patients or elicited by nonleading questions) were recorded on standard forms at every visit up to week 17."|Up to week 17|Safety population||percentage of patients|||Number
773643|NCT00740831|Primary|Co-primary Safety Endpoint: Serum Estradiol Levels at End of Treatment Visit (Week 13 Visit) for PGL4001 Compared With GnRHagonist|Measured by log 10 (log pg/ml) transformed values for estradiol (E2) in blood samples|Week 13 visit|Safety population||log 10 (log pg/ml) E2||Standard Error|Mean
773644|NCT00740831|Secondary|Change in the Total Volume of the Three Largest Myomas From Baseline to Week 13|"Assessment of PGL4001 capacity to decrease volume of the three largest myomas was performed at each center by means of ultrasonography at baseline and at week 13.
The total volume of the three largest myomas assessed at screening and at end-of-treatment visit (Week 13) was analysed on a logarithm transformed scale (to base 10)."|3 months|Per protocol||Log 10 (Log cm3) Total volume||Standard Error|Mean
773645|NCT00740831|Primary|Percentage of Subjects With Reduction of Uterine Bleeding at Week 13 Visit Defined as Pictorial Blood-loss Assessment Chart (PBAC) Score < 75 at End-of-treatment Visit (Week 13 Visit)|"Uterine bleeding was assessed with the use of the PBAC, a validated self-reporting method to estimate menstrual blood loss.
Patients recorded daily the number of tampons and towels used and the degree to which individual items were soiled with blood (plus small or large clots). Monthly scores range from 0 (amenorrhea) to more than 500, with higher numbers indicating more bleeding.
A slightly stained tampon/towel scores 1, a partially stained tampon/towel scores 5, a completely saturated tampon scores 10 and a completely saturated towel scores 20. Small clots/flooding (2cm) score 1. Large clots/flooding (3cm) score 5.
Menorrhagia is defined as a PBAC > 100 during one menstrual period which approximates to a blood loss of > 80 mL. A PBAC of 400 corresponds to a blood loss of around 300 mL or approximately 80 tampons/towels used.
The week 13 PBAC score was calculated using the last 28 days of treatment."|3 months|Per protocol||percentage of patients|||Number
773646|NCT00740857|Secondary|Time to First Perceptible Relief|The elapsed time from dosing until the patient indicated first perceptible relief, provided the subject also indicated achieving meaningful relief.|0-6 hours|All randomized patients who were dosed with study product, indicated a baseline score of at least 2 out of 4 on the Categorical Pain Severity Rating Scale and confirmed a pain assessment of at least 50 mm out of 100 mm on the Visual Analog Scale (VAS). Median pain relief was not reached for the placebo participants within 360 minutes.||minutes||95% Confidence Interval|Median
773647|NCT00740857|Secondary|Time-weighted Sum of Pain Relief Scores (TOTPAR) From 0-2 Hours and 0-6 Hours|TOTPAR is a derived endpoint from the pain relief scores from 0-2 hours and 0-6 hours. Range: 0 (worst) - 8 (best); 0 (worst) - 24 (best)|0-2 and 0-6 hours|All randomized patients who were dosed with study product, indicated a baseline score of at least 2 out of 4 on the Categorical Pain Severity Rating Scale and confirmed a pain assessment of at least 50 mm out of 100 mm on the Visual Analog Scale (VAS).||units on scale||Standard Deviation|Mean
773648|NCT00740857|Secondary|Time-weighted Sum of Pain Intensity Difference (SPID) From 0-2 Hours and 0-6 Hours|SPID is a derived endpoint from the pain intensity difference scores from 0-2 hours and 0-6 hours. Range: -2 (worst) to 6 (best); -6 (worst) to 18 (best).|0-2 and 0-6 hours|All randomized patients who were dosed with study product, indicated a baseline score of at least 2 out of 4 on the Categorical Pain Severity Rating Scale and confirmed a pain assessment of at least 50 mm out of 100 mm on the Visual Analog Scale (VAS).||units on scale||Standard Deviation|Mean
773649|NCT00740857|Secondary|Pain Relief Combined With Pain Intensity Difference (PRID) Scores at Individual Time Points|PRID (PRID=PID+PR) is a derived endpoint from the pain relief and pain intensity difference scores at each time point. Range: -1 (worst) to 7 (best).|0-6 hours|All randomized patients who were dosed with study product, indicated a baseline score of at least 2 out of 4 on the Categorical Pain Severity Rating Scale and confirmed a pain assessment of at least 50 mm out of 100 mm on the Visual Analog Scale (VAS).||units on scale||Standard Deviation|Mean
773663|NCT00741013|Secondary|Number of Total Nucleated Cells From Bronchoalveolar Lavage (BAL) Fluid 24 Hours After Endotoxin Instillation|Number of total nucleated cells isolated from the first aliquoe of BAL obtained to correlate with PET data.|24 hours after endotoxin instillation|||cells per cubic mm||Standard Deviation|Mean
773650|NCT00740857|Secondary|Time-weighted Sum of Pain Relief + Pain Intensity Difference (SPRID) From 0-2 Hours and 0-6 Hours|SPRID is a derived endpoint from the pain relief and pain intensity difference scores from 0-2 hours and 0-6 hours. PRID=PID+Pain Relief Score. SPRID-02 range: -2 (worst) to 14 (best); SPRID 06 range: -6 (worst) to 42 (best).|0-2 and 0-6 hours|All randomized patients who were dosed with study product, indicated a baseline score of at least 2 out of 4 on the Categorical Pain Severity Rating Scale and confirmed a pain assessment of at least 50 mm out of 100 mm on the Visual Analog Scale (VAS).||units on scale||Standard Deviation|Mean
773651|NCT00740857|Secondary|Pain Relief (PR) Scores at Individual Time Points|"Response to the question How much pain do you have from your starting pain? was recorded on a 5-point categorical pain relief scale (None (0), A Little (1), Some (2), A Lot (3) or Complete (4)) at designated time points after study medication was taken."|0-6 hours|All randomized patients who were dosed with study product, indicated a baseline score of at least 2 out of 4 on the Categorical Pain Severity Rating Scale and confirmed a pain assessment of at least 50 mm out of 100 mm on the Visual Analog Scale (VAS).||units on scale||Standard Deviation|Mean
773652|NCT00740857|Secondary|Pain Intensity Difference (PID) Scores at Each Individual Time Points|PID is based on the 4-point categorical pain severity score ranging from 0 (none) to 3 (severe), this value was derived by subtracting the score at each post-dosing time point from the baseline score, so that a higher positive value is indicative of greater improvement.|0-6 hours|All randomized patients who were dosed with study product, indicated a baseline score of at least 2 out of 4 on the Categorical Pain Severity Rating Scale and confirmed a pain assessment of at least 50 mm out of 100 mm on the Visual Analog Scale (VAS).||units on scale||Standard Deviation|Mean
773653|NCT00740857|Primary|Time to Meaningful Pain Relief|Subjects evaluated the time to “First Perceptible” Relief by depressing a stopwatch at the moment they first began to experience “perceptible” relief and the time to “Meaningful” Relief by depressing a second stopwatch at the moment they first began to experience “meaningful” relief. These times were recorded up to 6 hrs after dosing. Range: up to 6 hrs, a lower number is better.|0-6 hours|All randomized patients who were dosed with study product, indicated a baseline score of at least 2 out of 4 on the Categorical Pain Severity Rating Scale and confirmed a pain assessment of at least 50 mm out of 100 mm on the Visual Analog Scale (VAS). Median pain relief was not reached for the placebo participants within 360 minutes.||minutes||95% Confidence Interval|Median
786193|NCT00833690|Secondary|Serum Urate|From blood sample drawn prior to enrollment|Baseline Visit|||mg/dL||Standard Deviation|Mean
773664|NCT00741013|Primary|Change in Ki (Measure of [18F]Fluorodeoxyglucose ([18F]FDG) Uptake Determined by Patlak Graphical Analysis) in the Right Lung 24 Hours After LPS Instillation|Calculated Ki was used to measure the amount of lung inflammation before and after instillation of endotoxin to assess the effect of placebo, lovastatin, and rhAPC treatment|24 hours after endotoxin instillation|||Change in Ki||Standard Deviation|Mean
773665|NCT00741026|Secondary|Diastolic Blood Pressure|Diastolic Blood Pressure|3 Days|||mmHg||Standard Error|Mean
773666|NCT00741026|Secondary|Systolic Blood Pressure|Systolic Blood Pressure|3 Days|||mmHg||Standard Error|Mean
773667|NCT00741026|Secondary|Heart Rate|Heart Rate|3 Days|||beats per minute||Standard Error|Mean
773668|NCT00741026|Secondary|BMI|BMI|3 Days|||kg / m2||Standard Error|Mean
773669|NCT00741026|Secondary|Body Weight|Body Weight|3 Days|||kg||Standard Error|Mean
773670|NCT00741026|Secondary|Total Cholesterol|Total Cholesterol|3 Days|||mg/dl||Standard Deviation|Mean
773671|NCT00741026|Secondary|LDL Cholesterol|LDL Cholesterol|3 Days|||mg/dl||Standard Deviation|Mean
773672|NCT00741026|Secondary|Triglycerides|Triglycerides|3 Days|||mg/dl||Standard Deviation|Mean
773673|NCT00741026|Secondary|HDL Cholesterol|HDL Cholesterol|3 Days|||mg/dl||Standard Deviation|Mean
773674|NCT00741026|Primary|Plasma Free Fatty Acid|Plasma Free Fatty Acid|3 Days|||mM||Standard Deviation|Mean
773675|NCT00741026|Primary|Oral Glucose Tolerance|Oral Glucose Tolerance|3 Days|||min*mg/dl||Standard Deviation|Mean
773676|NCT00741026|Primary|Plasma Leptin|Leptin following placebo or olanzapine treatment|3 Days|||ng/ml||Standard Deviation|Mean
773677|NCT00741039|Primary|Determine Response Rate of Patients > or = to 65 Yrs Diagnosed|For Pneumovax, complete response will be either seroconversion or a >3 fold rise in titer against at least 5 of the following serotypes contained in Pneumovax (serotypes 4, 14, 19, 23, 6B, 18C, and 9V).|8-16 weeks following vaccination.|||participants|||Number
773678|NCT00741091|Secondary|Device Malfunction|Device Malfunction was defined as a failure of the device to meet performance specifications or otherwise perform as intended.|30 days|||Devices|||Number
773679|NCT00741091|Secondary|System Technical Success|System technical success included successful delivery and deployment of the FilterWire EZ System beyond the target lesion site, delivery and deployment of the Carotid WALLSTENT Endoprosthesis at the intended location, and successful retrieval of the delivery catheter and FilterWire EZ System after stent placement. System technical success rates was calculated based on the number of participants who had both the FilterWire EZ System and Carotid WALLSTENT Endoprosthesis placement attempted.|30 days|To be evaluable for system technical success, subjects needed to have a Carotid WALLSTENT deployment attempted.||Participants|||Number
773680|NCT00741091|Secondary|Target Lesion Revascularization|Number of participant with any surgical or percutaneous attempt to revascularize the target lesion after the initial treatment. The target lesion was defined as the stented segment including 0.5 cm at the proximal and distal margins of the stented segment.|30 days|||Participants|||Number
773681|NCT00741091|Secondary|Number of Participants With Device, Procedure, and Unrelated Adverse Events (AEs)|Adverse events, serious and non-serious, were reported by all study centers. Device related adverse events were defined as any adverse event related the study device as determined by the (Principal Investigator)PI. Procedure related adverse events were defined as any adverse event related the study procedure as determine by the PI. Unrelated adverse events were determined by the PI to not be related to the study device or study procedure.|30 days|||Participants|||Number
773682|NCT00741091|Primary|Composite of Major Adverse Events (MAE) Defined as Center-reported and Clinical Events Committee (CEC) Adjudicated Death, Stroke, and Myocardial Infarction (MI)|Number of participants who experienced a major adverse event (MAE) 0-30 days post-procedure. MAE was defined as add death, stroke, and myocardial infarction(MI).|30 days|All 1097 enrolled participants were considered for analysis. A total of 1025 subjects were evaluable for MAEs. Seventy two participants were not evaluable for MAEs; 32 participants were not evaluable because the follow-up occurred less than 23 days from enrollment and 40 participants did not complete the expected follow-up.||Participants|||Number
773683|NCT00741104|Primary|Number of Patients Agreeing to Participate in a Dose Reduction Study|"As part of the Remicade questionnaire, patients were asked would you consider participating in a dose reduction study?"|Measured from the Remicade Questionnaire at first (and only) study visit|Out of the 363 subjects in the analysis, 361 subjects answered this question.||participants|||Number
773684|NCT00741104|Primary|Patient Response to Increased Dosing Interval|"Among patients who reported that they at some occasion during treatment with infliximab had a longer dosing interval than every 8 weeks, patients were asked did you notice any difference when your dosing interval was extended? Those who noticed a difference were asked if their experience was positive or negative."|Measured from the Remicade Questionnaire at first (and only) study visit|Among the 363 patients, 106 patients reported that they at SOME occasion during treatment with infliximab had had a longer dosing interval than every 8 weeks. Among the 106 patients who increased dosing interval, 79 noticed a difference. These 79 were analyzed for this measure.||participants|||Number
773685|NCT00741104|Primary|Reason for Extending Dosing Interval|Among patients who reported that they at some occasion during treatment with infliximab had a longer dosing interval than every 8 weeks, the reason for extending dosing interval was asked of each patient.|Measured from the Remicade Questionnaire at first (and only) study visit|Among the 363 patients, 106 patients reported that they at SOME occasion during treatment with infliximab had had a longer dosing interval than every 8 weeks.||participants|||Number
773686|NCT00741104|Secondary|Duration of Subject's Rheumatoid Arthritis (RA) Diagnosis, European Quality of Life Group 1990 5 Dimension (EQ5D) and Patient Remicade Questionnaire.|This is not a prespecified key secondary outcome; therefore, results will not be disclosed|Measured at first (and only) study visit, and outcomes measured during the two preceding physician visits are extracted from the Swedish Rheumatoid Arthritis (RA) Registry.||||||
773687|NCT00741104|Secondary|Adverse Events (AEs)|This is not a prespecified key secondary outcome; therefore, results will not be disclosed|Collected at first (and only) study visit, all AEs reported during the previous 12 months is collected from the Swedish Rheumatoid Arthritis (RA) Registry.||||||
774216|NCT00745875|Secondary|Progression-free Survival|Median time (in days) from randomisation until disease progression/death using the Kaplan-Meier method|Tumour assessments for progression were performed at screening, every 3 weeks, Mandatory Tumour Assessment Visit (19 August 2009 ± 3 days), treatment discontinuation|||Days||Full Range|Median
773688|NCT00741104|Secondary|Disease Activity Score Based on Assessment of 28 Joints (DAS28), Health Assessment Questionnaire (HAQ), C-reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR), Infliximab Dosage.|This is not a prespecified key secondary outcome; therefore, results will not be disclosed|Measured at first (and only) study visit, and outcomes measured during the two preceding physician visits are extracted from the Swedish Rheumatoid Arthritis (RA) Registry.||||||
773689|NCT00741104|Primary|Dosing Interval Between the Infliximab Infusions|Patients were asked as part of the Remicade questionnaire what dosing interval they were on.|Measured from the Remicade Questionnaire at first (and only) study visit|||participants|||Number
773690|NCT00741156|Primary|Systemic, Pulmonary and Cerebral Resistance at Baseline and After Enalaprilat|Systemic, pulmonary and cerebral resistance is compared at baseline and after enalaprilat|Baseline and after enalaprilat|||Wood units per metre squared||Full Range|Median
773691|NCT00741156|Primary|Systemic, Pulmonary and Cerebral Blood Flow at Baseline and After Enalaprilat||Baseline and after enalaprilat|||l/min/m2||Inter-Quartile Range|Median
773692|NCT00741273|Primary|Proellex Half-life (T1/2)|Time for Proellex concentration to decrease by half (T1/2) of a single dose of 25mg and 50mg of Proellex® in female patients with impaired hepatic function and in volunteers with normal hepatic function,measured from samples collected at: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 5, 7, 9, 12, 16, 20, 24, 32, 36, 40 and 48 hours post dose..|48 hours|||Hours||Standard Deviation|Mean
773693|NCT00741273|Secondary|Area Under the Curve (AUC0-t) for Proellex|AUC0-t of a single dose of 25mg and 50mg of Proellex® in female patients with impaired hepatic function and in volunteers with normal hepatic function, measured from samples collected at: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 5, 7, 9, 12, 16, 20, 24, 32, 36, 40 and 48 hours post dose.|48 hours|||ng x min/L||Standard Deviation|Mean
773694|NCT00741273|Primary|Maximum Blood Concentration (Cmax)|Cmax of a single dose of 25mg and 50mg of Proellex® in female patients with impaired hepatic function and in volunteers with normal hepatic function, assessed from samples collected at: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 5, 7, 9, 12, 16, 20, 24, 32, 36, 40 and 48 hours post dose..|48 hours|||ng/L||Standard Deviation|Mean
773695|NCT00741286|Secondary|Number of Patients With First Recurrent Stroke of Any Type||90 days|||participants|||Number
773696|NCT00741286|Primary|The Changes of Middle Cerebral Artery (MCA) and Basilar Artery (BA) Pulsatility Index (PI) at 14 and 90 Days From the Baseline Transcranial Doppler (TCD) Study|The PI is designed to measure vascular resistance and characterizes the shape of the spectral waveform. For the study, the mean, systolic, and diastolic flow velocities were measured using TCD. Gosling’s PI was determined as the difference between the peak systolic and end-diastolic velocities divided by the mean flow velocity in each artery.The changes of MCA and BA PIs at 14 and 90 days from the baseline TCD study was calculated for the study.|14 days and 90 days from the baseline TCD study|Of the 203 patients included in the intention-to-treat analysis, 164 were included in the per-protocol analysis of the primary outcome.||ratio||Standard Deviation|Mean
773697|NCT00741338|Secondary|Percent Reduction of Urinary Glycosaminoglycan (uGAG) Level From Baseline to the End of Treatment/Early Withdrawal|Urinary Glycosaminoglycan (uGAG) Levels: concentration of glycosaminoglycan (GAG) relative to creatinine in urine. A greater decrease in uGAG level indicates a greater response.|Baseline, end of treatment/early withdrawal (up to 24 weeks after start of full-dose laronidase therapy)|Safety population included all participants who received any study drug treatment.||percent change in uGAG level||Full Range|Median
773698|NCT00741338|Primary|Number of Participants Who Achieved Immune Tolerance Induction|Immune tolerance induction success was defined as development of an anti-laronidase immunoglobulin G (IgG) antibody titer less than or equal to (<=) 1:3200 after 24 weeks of receiving full-dose (0.58 mg/kg) laronidase therapy.|24 weeks after start of full-dose laronidase therapy|Safety population included all participants who received any study drug treatment.||participants|||Number
773699|NCT00741390|Secondary|Reported Device Preference Within Lancing Pair at Visit 2|"After each pair of 4 lancings, the subject was asked: Which of the two devices did you find more comfortable, overall? The choices were: first lancing, second lancing or equivalent. The Stated Preference row indicates # of lancing pairs in which one device was preferred over the other device while the 2 rows below indicate the # of pairs in which each device was preferred. First and second device refers to the 1st and 2nd devices identified in column headers, not the device order during testing. The No Preference row includes lancing pairs with preference of equivalent or no answer."|Approximately Day 3 (Visit 2)|Comfort was analyzed per lancing pairs. 236 subjects performed up to 4 lancing pairs. 869 pairs were evaluated across the 4 arms. Pairs were excluded if they did not result in a valid meter reading or associated with protocol deviations or had missing comfort data.||lancing pairs|||Number
773700|NCT00741390|Secondary|Difference in Lancing Pain for Devices in Visit 2 Only. (For Subjects Assigned to Arm D Only)|"The subjects who participated in Study Visit 2 kept the same group assignment they had in Study Visit 1. Each subject tested 2 of the 3 systems they experienced during Visit 1. Up to 6 pairs of lancings were performed in order to obtain 4 evaluable pairs.
After each pair of lancing, the subject was asked to record the difference in the pain they perceive between two lancing systems using the 150 mm visual analog scale. A positive value on the scale (and in the table below) indicates that the first device in the pair was more painful than the second."|Approximately Day 3 (Visit 2)|61 subjects in this arm completed visit 1 and evaluable data for lancing pain. See further description above.||mm||Standard Deviation|Mean
773701|NCT00741390|Primary|Difference in Lancing Pain for Device Pair at Visit 2. (For Subjects Assigned to Arms A, B, C Only)|In Visit 2 subjects kept the same group assignment they had in Visit 1. Each subject tested 2 of the 3 systems from Visit 1. Up to 6 pairs of lancings were performed in order to obtain 4 evaluable pairs. After each pair of lancing, the subject was asked to record the pain from the 2nd lancing as compared to the first using a 150mm visual analog scale(0mm = same pain, -75mm = max score for less painful than first lancing,+75mm = max score for more painful). A positive value on the scale (and in table below) indicates that the first device in the pair was more painful than the second.|Approximately Day 3 (Visit 2)|Of the 234 subjects that completed Visit 2, 229 had evaluable pairs and were included in the analysis for Visit 2. Some of the lancing pairs from several subjects were excluded due to protocol deviations, subject discontinuation or adverse events. Of these 175 subjects were analyzed for this primary outcome.||mm||Standard Deviation|Mean
786953|NCT00848250|Primary|(PAI-1) Plasminogen Activator Inhibitor -1 Antigen||Baseline (prior to surgery), On CPB for 30 minutes, At completion of CPB, and postoperative day 1 (at 8:00AM)postoperative day 1|||ng/ml||Standard Error|Mean
773702|NCT00741390|Primary|Blood Sample of Sufficient Volume to Yield a Valid Meter Reading|Number of subjects in whom valid meter reading was obtained with each device configuration. The primary outcome of a successful lancing is defined as whether or not a technician is able to use the lancing system to yield a blood sample of sufficient volume to yield a valid meter reading.|Study Day 1 (Visit 1)|BD/BD33g and Mini/BD33g were included in 4 arms,the Mini/OT28g in 2 arms,and Ultra/OT28g and AC/AC28g in 1 arm. Thus the # of subj evaluated for each device was 246, 246, 124, 63, and 60, resp. Subj were analyzed for blood volume adequacy if they completed the depth setting/volume testing for at least 1 device w/o significant protocol deviation.||Participants|||Number
773703|NCT00741468|Primary|Plasma AUC Ratio of Day 1 and Day 8|"Assessment of the drug-drug interactions of Proellex® (CDB-4124) with cytochrome P450 isoenzymes CYP1A2, 2C9, 2C19, 2D6, and 3A4 in healthy female subjects administered 50 mg Proellex® once daily (QD). The Day 8 AUC was compared to the Day 1 AUC to determine inhibition.
For CYP1A2 the plasma paraxanthine/caffeine MR ratio (metabolic ratio) was used. For CYP2D6 the MR ratio of dextromethorphan/dextrorphan was used."|8 days|One subject had concentrations of Proellex (CDB-4124 and CDB-4453) that were below the lower level of quantitation at all time points tested and was excluded from the pharmacokinetic analyses.||Ratio of geometric means Day 8 to Day 1||90% Confidence Interval|Mean
773704|NCT00741598|Secondary|Quality of Life Satisfaction Questionnaire (Q-LES-Q)|"The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) is a self-report instrument designed to measure the degree of enjoyment and satisfaction experienced by subjects in various areas of daily functioning. There are 16 areas of functioning, each scored from 1 (very poor) to 5 (very good). The range of scores is 16-80, with lower scores representing lower functioning and satisfaction.
The outcome measures presented are Q-LES-Q Total score = Sum of all scores from all 16 areas of functioning"|Screening|||units on a scale||Standard Deviation|Mean
773705|NCT00741598|Secondary|The Range of Impaired Functioning Tool (LIFE-RIFT)|The LIFE-RIFT is a brief measure of functional impairment. The total scale score is a sum of four items with range of scale from 0 to 26 (from no impairment to severe impairment).|Baseline, Weeks 4, 8, 12, and 16|||units on a scale||Standard Deviation|Mean
773706|NCT00741598|Primary|The Conners' Continuous Performance Test (CPT) at Baseline, Weeks 4, 8, 12, and 16|"Conner’s CPT (Conner’s Continuous Performance Task) is a neuropsychological test that measures a person's sustained and selective attention. Subjects are instructed to click the space bar when they are presented with any letter except the letter X. The person must refrain from clicking if they see the letter X presented. Clicking to the letter “X” is a commission error, not clicking to other letters are omission errors.
The outcome measures presented are Total number of errors = Total number of omission + commission errors This outcome measure is presented at each study visit (baseline, week 4, week 8, week 12, and week 16)"|Measured at screening; baseline; and Weeks 4, 8, 12, and 16|||total number of errors||Standard Deviation|Mean
773707|NCT00741598|Primary|Scores on the Wisconsin Card Sorting Test (WCST) at Screening and Week 16|"WCST (Wisconsin Card Sorting Test) is a neuropsychological test measuring the ability to display flexibility in the face of changing schedules of reinforcement. Subjects are presented with cards and requested to match them. Unbeknownst to the subject, the matching rules change while the test is delivered. The test measures subjects' ability to understand the new rules.
The outcome measures presented are Total correct baseline = total correct card choices at baseline Total errors baseline = total erroneous card choices at baseline Total correct week 16 = total correct card choices at week 16 Total errors baseline = total erroneous card choices at week 16"|Measured at screening and Week 16|||number of card choices made||Standard Deviation|Mean
773708|NCT00741598|Primary|Scores on the California Verbal Learning Test (CVLT-II) at Screening and Week 16|"CVLT is a test measuring verbal learning and verbal memory. Subjects are expected to remember a list of words. They are asked to repeat the words remembered 5 times (5 trials). Each of the words correctly remembered, in each trial, is marked as 1 point. The outcome measures presented are:
CVLT Total Trials 1-5, Baseline = Number of total words remembered, sum of trials 1-5, at baseline CVLT Total Trials 1-5, Week 16 = Number of total words remembered, sum of trials 1-5, at week 16."|Measured at screening and Week 16|||number of total words remembered||Standard Deviation|Mean
773709|NCT00741611|Secondary|Number of Participants With Acute Procedural Success in Mesh Treated Patients.|Acute procedural success was defined as the ability to isolate 3 of 4 pulmonary veins with the mesh ablation system alone without the need for further ablation with a distal tip catheter|During the mesh ablation procedure|All mesh treated patients.||participants|||Number
773710|NCT00741611|Secondary|Number of Participants With the Occurrence of Pulmonary Vein Stenosis in Mesh Treated Patients.|Defined as a greater than or equal to 70% diameter reduction in a pulmonary vein compared with the baseline measurement as assessed by an independent core imaging laboratory.|12 months|All mesh treated patients.||participants|||Number
773711|NCT00741611|Primary|Number of Participants With Freedom From Symptomatic Atrial Fibrillation|Due to the early termination and the enrollment of only seven randomized patients, the endpoint was not evaluable.|12 months|All treated patients|||||
773712|NCT00741611|Primary|Number of Participants With Serious Atrial Fibrillation Events|Due to the early study termination and the small number of randomized patients (seven), this primary endpoint analysis (comparison of the rate of events in the mesh group to the rate in the drug group) could not be performed. Counts of events occurring in the 36 treated patients are reported by study group instead.|12 months|All treated patients.||participants|||Number
773713|NCT00741611|Primary|Number of Participants With Major Complications|A Major Complication was defined as any adverse event that met the following criteria: 1) event was a Serious Adverse Event; 2) event was related to study device (mesh/mesh toolkit) or study procedure and 3)event was a) a cardiovascular adverse event occurring within 7 days of the procedure and/or b) a direct ablation effect adverse event occurring within 12 months of the study procedure.|12 months|Patients who were treated with the HD Mesh Ablation System||participants|||Number
773714|NCT00741819|Secondary|Drug Administration Activities Questionnaire|Change in tasks from Baseline to Week 12. At Baseline and Week 12, subjects provided information related to the daily administration and time requirements of inhaled iloprost (Baseline) and inhaled treprostinil (Week 12).|Baseline and 12 weeks|Subjects who completed the questionnaire at Baseline and Week 12.||minutes||Standard Deviation|Mean
774217|NCT00745875|Primary|Time to Death|Median time (in days) from randomisation until death using the Kaplan-Meier method (Calculator for survival probability)|Patients were followed up for survival every week for the first 3 weeks then every 3 weeks whilst on study medication until the data cut-off (17th January 2010).|||Days||Full Range|Median
773715|NCT00741819|Secondary|World Health Organization (WHO) Functional Class|Change in WHO Functional Class (FC) from Baseline to Week 12. Data presented as percent of subjects who either improved FC, worsened FC, or had no change in FC from Baseline to Week 12.|Baseline and 12 Weeks|Subjects still enrolled at Week 12 with a WHO Functional Class at Baseline and Week 12.||percentage of subjects|||Number
773716|NCT00741819|Secondary|N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP)|Change in NTpro-BNP from Baseline to Week 12. Blood samples were collected for plasma NTpro-BNP analysis during the study.|Baseline and Week 12|Subjects with a NTproBNP sample drawn at Baseline and Week 12||pg/mL||Full Range|Median
773717|NCT00741819|Secondary|Patient Impression of Change|The patient impression of change (PIC) was three single therapy-related questions related to the subjects overall impression of the transition from inhaled iloprost to inhaled treprostinil. Subjects were surveyed related to their overall impression of the transition from inhaled iloprost to inhaled treprostinil at Week 12.|Baseline and 12 weeks|Subjects who completed questionnaire at Baseline and Week 12||percentage of patients|||Number
773718|NCT00741819|Secondary|Treatment Satisfaction Questionnaire of Medication (TSQM)|Change in TSQM score from Baseline to Week 12. The TSQM is a validated instrument (Health and Quality of Life Outcomes 2004, 2:12) that measures major dimensions of patient satisfaction with medications. The questionnaire is comprised of 15 questions which fall into one of four categories; Effectiveness, Side-Effects, Convenience, and Global Satisfaction. Responses are scaled on a seven point bipolar scale from 'Extremely Satisfied' to 'Extremely Dissatisfied' where higher scores indicate improvements (total scores from 0-100). The questionnaire was completed at Baseline and Week 12. The Baseline questionnaire focused on the subject’s satisfaction with inhaled iloprost treatment, while the questionnaire completed at Week 12 focused on the subject’s satisfaction with inhaled treprostinil.|Baseline and 12 weeks|Subjects who completed the TSQM at Baseline and Week 12. Total analysis population was less for the Convenience Score (N=67) and Global Satisfaction Score (N=66).||units on a scale||Full Range|Mean
773719|NCT00741819|Secondary|Quality of Life (QoL) Assessment: Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR)|Change in CAMPHOR Scores from Baseline to Week 12. The CAMPHOR is a health related quality of life instrument validated for pulmonary hypertension that assesses impairment (symptoms), disability (activities) and quality of life. The questionnaire is divided into three sections; Symptoms (Scores 0-25; high scores indicate more symptoms), Activity (Score 0-30; low score indicates good functioning)and Quality of Life (0-25; high scores indicate poor QoL). The sum of these scores equates to the Total score (0-80). In the CAMPHOR scores, lower scores indicate improvements.|Baseline and 12 weeks|Subjects who were still enrolled and completed the questionnaire at Baseline and Week 12. Total analysis population was less for the activity score and total score (N = 67).||units on a scale||Full Range|Mean
773720|NCT00741819|Secondary|Six-minute Walk Distance (6MWD)|Change in 6MWD from Baseline to Week 12. The 6-minute walk test (6MWT) was conducted at Baseline (10–30 minutes following the last dose of inhaled iloprost) and at Week 12 (10–60 minutes following the dose of inhaled treprostinil). The change in distance (meters) between Baseline and Week 12 is reported below.|Baseline and 12 weeks|Subjects enrolled at Week 12 visit.||meters||Full Range|Median
773721|NCT00741819|Primary|Number of Adverse Events|Overall safety of transitioning from inhaled iloprost to inhaled treprostinil was assessed by type and frequency of adverse events.|up to 24 months|All subjects who received at least one dose of inhaled treprostinil were included in the safety analysis population.||number of events|||Number
773722|NCT00741858|Primary|Physical Health Quality of Life|Physical health quality of life (based on SF-36 results) (SF-36 includes 8 scores scaled 0-100; lower score indicating more disability)|7 years|||units on a scale||Standard Error|Mean
773723|NCT00741936|Secondary|Serum Glutamic Oxaloacetic Transaminase (SGOT)||Pre-treatment (Wk2) & Post-treatment (Wk10)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.||U/L||Standard Deviation|Mean
773724|NCT00741936|Secondary|Serum Glutamic Pyruvic Transaminase(SGPT) Level||Pre-treatment (Wk2) & Post-treatment (Wk10)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.||U/L||Standard Deviation|Mean
773725|NCT00741936|Secondary|Blood Creatinine Level||Pre-treatment (Wk2) & Post-treatment (Wk10)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.||μmol/L||Standard Deviation|Mean
773726|NCT00741936|Secondary|Blood Urea Level||Pre-treatment (Wk2) & Post-treatment (Wk10)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.||mmol/L||Standard Deviation|Mean
773727|NCT00741936|Primary|Responder of Complete Spontaneous Bowel Movement (CSBM)|Patients with a mean increase of ≧1 complete spontaneous bowel movement(CSBM)/wk compared with the baseline(wk1-2) will be defined as responders. CSBM referred to the feeling that defecation led to complete passage of stool rather than partial or incomplete evacuation without the use of any laxative or enema within 24 hours.|End of treatment (wk10)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.||participants|||Number
773728|NCT00741936|Secondary|Success of Blinding|The success of blinding was evaluated for both investigator and patients as to whether MZRW or placebo had been taken.|End of follow-up (Wk18)|Only for subjects attended the last follow-up visit on Wk 18.||participants|Participants||Number
773729|NCT00741936|Secondary|Global Symptoms Improvement|"Participants were asked to rate their impression of change in constipation by comparing with their baseline (Wk2) at the visits during the treatment (Wk6), end of treatment (Wk10) and end of follow-up (Wk18) with scores from 0 to 6 represented markedly worse or better respectively. The response categories were collapsed to simply improved for score 4 to 6, same for score 3 or worse for score 0 to 2."|Wk 6, 10 & wk 18|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.||participants|||Number
773965|NCT00737178|Primary|Use of the IUD for Contraception at Six Months|Six months after enrollment, we determined whether or not women were using the IUD through in-person exit interviews and phone interviews. This was an intention to treat analysis, comparing the proportion of women using the IUD based on their group assignment (immediate or delayed).|6 months|||participants|||Number
773730|NCT00741936|Secondary|Changes on Individual Symptom Scores|It was a 7-point ordinal scale from 0=not at all to 6=very severe.|Baseline(Wk2), Within treatment(Wk6), End of treatment(Wk10) & End of follow-up(Wk18)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.||Units on a scale||Standard Deviation|Mean
773731|NCT00741936|Secondary|Complete Spontaneous Bowel Movement (CSBM)||Baseline(Wk1&2), Within treatment(Wk3-10), Within follow-up(Wk11-18)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.||movements per week||Standard Deviation|Mean
773732|NCT00741936|Secondary|Bowel Movement||Baseline(Wk1&2), Within treatment(Wk3-10) & Within follow-up(Wk11-18)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.||movements per week||Standard Deviation|Mean
773733|NCT00741936|Secondary|Responder of Complete Spontaneous Bowel Movement (CSBM)|"Participants with a mean increase of complete spontaneous bowel movement (CSBM)>=1 movement per week compared with the last 14 days of the run-in period were defined as responders.
CSBM referred to the feeling that defecation led to complete passage of stool rather than partial or incomplete evacuation without the use of any laxative or enema within 24 hours."|End of follow up (wk18)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.||participants|||Number
773734|NCT00741988|Secondary|Characterization of the Toxicity in Patients With Previously Untreated Advanced NSCLC Treated With Ixabepilone and Carboplatin With and Without Bevacizumab.||18 months||||||
773735|NCT00741988|Secondary|Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death||18 months|||months||95% Confidence Interval|Median
773736|NCT00741988|Secondary|Progression Free Survival, the Length of Time, That Patients Were Alive From Their First Date of Treatment Until Worsening of Their Disease||18 months|||months||95% Confidence Interval|Median
773737|NCT00741988|Primary|Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment|The Percentage of Patients Who Experience an Objective Benefit From Treatment|18 months|||percentage of participants||95% Confidence Interval|Number
773738|NCT00742053|Primary|Distance of Maximum P-wave Amplitude in Relation to Superior Vena Cava (SVC)/Right Atrium(RA) Junction|In order to determine correlation of PICC tip location with the intracatheter ECG, the PICC was advanced at 1cm increments and the p-wave observed for amplitude changes.|during catheter insertion|||cm||Standard Deviation|Mean
773739|NCT00742079|Secondary|Select Items From the Maudsley Assessment of Delusions Scale||Measured at Baseline, Week 1, and Week 2||||||
773740|NCT00742079|Secondary|Affective Salience Task||Measured at Baseline, Week 1, and Week 2||||||
773741|NCT00742079|Secondary|Bead Task Measuring Probabilistic Reasoning||Measured at Baseline, Week 1, and Week 2||||||
773742|NCT00742079|Secondary|Beck Cognitive Insight Scale (BCIS)||Measured at Baseline, Week 1, and Week 2||||||
773743|NCT00742079|Secondary|Psychotic Rating Scales (PSYRATS)||Measured at Baseline, Week 1 and Week 2||||||
773744|NCT00742079|Secondary|Predictors of Response to D-cycloserine Facilitation of CBT for Delusions in Baseline Characteristics||Measured at baseline||||||
773745|NCT00742079|Primary|Alternative Beliefs Assessment|Number of alternative beliefs generated on the Alternative Beliefs Assessment. This assessment used nine vignettes describing social interactions: three of neutral content, three negatively-valanced, and three tailored to the patient's specific delusions. Participants were asked to generate as many explanations (alternative beliefs) as they could for each scenario, and the number of explanations produced in response to each item was recorded. Scores could range from 0 to as many explanations a person could produce (no maximum value). The total score was calculated by adding all alternative beliefs generated from each vignette. A higher number of alternative beliefs generated reflects a greater degree of cognitive flexibility.|Baseline vs. Week 1 vs. Week 2|||units on a scale||Standard Error|Mean
773746|NCT00742170|Secondary|Opioid Craving (Self-report)|Self-report on scale of 3 to 30 (higher number indicates more craving)|at 2-weeks post discharge|||units on a scale||Standard Deviation|Mean
773747|NCT00742170|Primary|Percent of Participants Using Drugs||2 weeks following discharge|||percent|||Number
773748|NCT00742183|Primary|Compare the Costs of Using the Interventions (Direct and Indirect)|"The incremental cost-effectiveness ratio is calculated as the difference in total costs in each group divided by the difference in rate of full re-epithelialization (taken from the survival curve) at 20 days in each group (Δcosts/ Δeffects). Total costs were calculated based on the costs of primary and secondary dressings, silver sulphadiazine cream and estimated application, labor, supplies and pain medications. These costs were estimated from a representative sample of each population, across study facilities, using activity-based costing methods.
The incremental cost-effectiveness ratio is interpreted as the price of additional health benefits. The ratio is supposed to be used by decision makers, in order for them to compare their willingness-to-pay for an additional health benefit with the pr"|August 2008-August 2009|||dollars||95% Confidence Interval|Mean
773749|NCT00742209|Other Pre-specified|Assessment of Treatment Satisfaction Using the Patient Perception of Migraine Questionnaire (PPMQ-R) at Week 17|"Three global treatment satisfaction items from the PPMQ included satisfaction or dissatisfaction with Medication Effectiveness, Medication Side Effects, and Overall Medication. Each item on the PPMQ uses a 7-point satisfaction scale (1 = Very Satisfied to 7 = Very Dissatisfied). Satisfied participants include those reporting Very Satisfied (scale value = 1) or Satisfied (scale value = 2) on the scale."|Week 17|ITT Population||Percentage of Patients|||Number
773750|NCT00742209|Other Pre-specified|Mean Change From Baseline in Productivity as Measured by Lost Time Equivalents (LTE) - (Work Activities, Non-work Activities, and Combination of Work and Non-work Activities)|Productivity, as measured by LTE, is a metric used to assess productivity loss in migraine. It is a composite measure of presenteeism (continued to work while under the influence of migraine symptoms) and absenteeism (time missed from work due to migraine), and can be applied to productivity for work and non-work activities. Productivity data were collected via an e-diary, and productivity measures were summarized for each study phase by averaging each measure across migraine attacks for each participant.|Week 17|ITT Population||Hours||Standard Error|Mean
773751|NCT00742209|Other Pre-specified|Mean Change From Baseline in the Headache Impact Test (HIT-6) Total Scores at Week 17|The HIT is a 6-item, self-administered HRQOL questionnaire used to measure six areas that impact headaches have on participants' ability to function on the job, at school, at home, and in social situations. Participants provide responses to questions using a 5-point Likert-type scale. All item values range from 6 to13.The total scores range from 36 to 78, where higher scores indicate greater impact on a participant's life.|Week 17|ITT Population||Points on a scale||Standard Error|Mean
773752|NCT00742209|Other Pre-specified|Mean Change From Baseline in Migraine Specific Quality of Life Questionnaire (MSQ v2.1) Composite Score and Subscales (Role Function Restrictive, Role Function, Preventive, & Emotional Function) at Week 17|The MSQ is a 14-item health-related quality of life (HRQOL) questionnaire. Participants provide responses using a 6-point Likert scale (1=None of the time, 2= A little bit of the time, 3=Some of the time, 4=A good bit of the time, 5=Most of the time, 6=All of the time) that are then recoded with a final item value where 1=6, 2=5, 3=4, 4=3, 5=2, and 6=1. The scale measures 3 independently scored dimensions (Role Function Restrictive, Role Function, Preventive, and Emotional Function) of HRQOL that are affected by migraine. For each dimension, a higher score indicates a better health status.|Baseline and Week 17|ITT Population||units on a scale||Standard Error|Mean
773753|NCT00742209|Secondary|Number of Participants Who Were “Much Improved” or “Very Much Improved” (Responders) on the 7-point Likert Clinical Global Impression of Change (CGIC) Scale Using LOCF at Week 17|"The CGIC is a single question measured on a 7-point Likert Scale. (1 = “very much improved”; 2= much improved, and 7 = “very much worse”) designed to give an assessment of treatment from a clinician's perspective. A responder is defined as being 'Very much improved' or 'much improved'."|Week 17|ITT Population||Participants|||Number
773754|NCT00742209|Secondary|Number of Participants Who Were “Much Improved” or “Very Much Improved” on the 7-point Likert Patient Global Impression of Change (PGIC) Scale Using LOCF at Week 17|"The PGIC is a single question measured on the 7-point Likert Scale (1 = “very much improved”; 2 = much improved; 7 = “very much worse”). A responder is defined as being very much improved or much improved."|Week 17|ITT Population||participants|||Number
773755|NCT00742209|Secondary|Percentage of Participants Classified as Responders for Each of the Following Measures: Migraine Headache Days, Migraine Attacks, and Migraine Headache Periods|A responder is defined as a participant who achieved at least a 50% reduction from baseline for the indicated measures.|Baseline to the Last 4 weeks of treatment|ITT Population||percentage of participants|||Number
773756|NCT00742209|Secondary|Mean Change From Baseline in Percentage of Migraine Attacks With Each of the Following Migraine Symptoms: Aura, Nausea, Vomiting, Photophobia, Phonophobia|The endpoint is defined as the percentage of attacks with each symptom (separately) for each study phase. Migraine symptoms aura, nausea, vomiting, photophobia, and phonophobia are defined as the presence of each migraine symptom during any of the headache events within an attack.|Baseline and last 4 weeks of treatment prior to taper (up to Week 17)|ITT Population||Percentage of MA with migraine symptoms||Standard Error|Mean
773757|NCT00742209|Secondary|Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered by Prescription Headache Medication Use|The Number of Acute Migraine Medication Doses Administered by Prescription Headache Medication use was measured via the participant-assessed Daily Migraine Diary.|Baseline and last 4 weeks of treatment prior to taper (up to Week 17)|ITT Population||Acute Migraine Medication Doses||Standard Error|Mean
773758|NCT00742209|Secondary|Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered by Opioid Use|The Number of Acute Migraine Medication Doses Administered by Opioid Use was measured via the participant-assessed Daily Migraine Diary.|Baseline and last 4 weeks of treatment prior to taper (up to Week 17)|ITT Population||Days||Standard Error|Mean
773759|NCT00742209|Secondary|Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered by Triptan Use|The Number of Acute Migraine Medication Administered was measured via the participant-assessed Daily Migraine Diary.|Baseline and last 4 weeks of treatment prior to taper (up to Week 17)|ITT Population||Acute Migraine Medication Dose||Standard Error|Mean
773760|NCT00742209|Secondary|Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered|The Number of Acute Migraine Medication Doses Administered was captured via the participant-assessed Daily Migraine Diary.|Baseline and last 4 weeks of treatment prior to taper (up to Week 17)|ITT Population||Acute Medication Doses Admin.||Standard Error|Mean
773761|NCT00742209|Secondary|Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Days of Acute Migraine Medication Use|The Number of Days of Acute Migraine Medication Use was assessed via the participant-assessed Daily Migraine Diary.|Baseline and last 4 weeks of treatment prior to taper (up to Week 17)|ITT Population||Days||Standard Error|Mean
773762|NCT00742209|Secondary|Change From Baseline in the Mean Peak Migraine Pain Severity|Peak Migraine Pain Severity was measured using a 4-point scale (0=none, 1=mild, 2=moderate, or 3=severe) on a participant self assessed Daily Migraine Diary. The scale measured the maximum pain severity across all headache events considered to be one attack.. Change from baseline and the last 4 weeks of treatment prior to taper were calculated means of the number of migraine headache days using the Last Observation Carried Forward (LOCF). The last 4-week treatment phase is based on the last 4 weeks prior to taper for each participant.|Baseline and last 4 weeks of treatment prior to taper (up to Week 17)|ITT Population||Scores on a Scale||Standard Error|Mean
773763|NCT00742209|Secondary|Change From Baseline in the Mean Migraine Attack Duration|The total duration of a migraine attack is measured from migraine attack onset until the resolution of the attack measured in hours and may include more than 1 headache event. The duration is assessed using a Daily Migraine Diary. Change from baseline and the last 4 weeks of treatment prior to taper were calculated means of the number of migraine headache days using the Last Observation Carried Forward (LOCF). Change from baseline is calculated as post-baseline minus baseline. The last 4-week treatment phase is based on the last 4 weeks prior to taper for each participant.|Baseline and last 4 weeks of treatment prior to taper (up to Week 17)|ITT Population||Hours||Standard Error|Mean
773949|NCT00737061|Secondary|Device Placement Rate|Defined as successful bilateral tubal access followed by successful bilateral RF treatment and matrix placement.|After First Treatment Attempt|Device placement rate reported on a per participant basis for 645 intent to treat participants. Successful bilateral placement of the matrices was achieved in 604/645 participants after the first procedure.||percentage of participants|||Number
773764|NCT00742209|Secondary|Mean Change From Baseline in the Number of Migraine Headache Periods (MHP)|A migraine headache period is a 24-hour block of time that begins at the onset of a migraine event . The 24-hour period is not linked directly with a calendar day. The change from baseline and the last 4 weeks of treatment prior to taper were calculated means of the number of migraine headache periods using the Last Observation Carried Forward (LOCF). The last 4-week treatment phase is based on the last 4 weeks prior to taper for each participant.|Baseline and last 4 weeks of treatment prior to taper (up to Week 17)|ITT Population||Migraine Headache Periods (MHP)||Standard Error|Mean
773765|NCT00742209|Secondary|Adjusted Mean Change From Baseline in the Number of Migraine Attacks|A migraine attack is defined as a migraine headache of at least 30 minutes in duration and may also include recurring non-migraine or migraine headaches . Change from baseline and the last 4 weeks of treatment prior to taper were calculated means of the number of migraine attacks using the Last Observation Carried Forward (LOCF). The last 4-week treatment phase is based on the last 4 weeks prior to taper for each participant.|Baseline and last 4 weeks of treatment prior to taper (up to Week 17)|ITT Population||Migraine Attacks||Standard Error|Mean
773766|NCT00742209|Secondary|Mean Change From Baseline in the Number of MHD in All Study Phases|A migraine headache day is defined as a calendar day with any occurrence of migraine headache pain of at least 30 minutes in duration. Change from baseline and the last 4 weeks of treatment prior to taper were calculated means of the number of migraine headache days using the Last Observation Carried Forward (LOCF). Change from baseline is calculated as post-baseline minus baseline. The last 4-week treatment phase is based on the last 4 weeks prior to taper for each participant.|Baseline and last 4 weeks of treatment prior to taper (up to Week 17)|ITT Population||Migraine Headache Days (MHD)||Standard Error|Mean
773767|NCT00742209|Primary|Adjusted Mean Change From Baseline in the Number of Migraine Headache Days (MHD) During the Last 4 Weeks of Treatment Prior to Taper|A migraine headache day is defined as a calendar day with any occurrence of migraine headache pain of at least 30 minutes in duration. Change from baseline was calculated as the mean number of MHD over the last 4 weeks of treatment prior to taper minus the number at baseline using the Last Observation Carried Forward (LOCF). The last 4-week treatment phase is based on the last 4 weeks prior to taper for each participant.|Baseline and last 4 weeks of treatment prior to taper (up to Week 17)|Intent to treat (ITT). There were 3 subjects who were randomized but did not take investigational product, and, therefore were not included in the Safety, ITT, or Per Protocol (PP) population.||Migraine Headache Days (MHD)||Standard Error|Least Squares Mean
773768|NCT00742235|Primary|Baseline 25-OH Vitamin D Level||Baseline|||ng/ml||Inter-Quartile Range|Median
773769|NCT00742235|Primary|hCAP18 Levels||Baseline|||ng/ml||Standard Deviation|Mean
773770|NCT00742274|Primary|Composite of Partial or No False Lumen Thrombosis, Aortic Rupture, and Aortic Dilatation|"Subjects with any of the following met this composite outcome:
partial/no false lumen thrombosis
aortic rupture
aortic dilatation
lack of 1 year imaging (no image, incomplete image missing primary endpoint measurements, unevaluable image)"|1 year|Intent to Treat (ITT)||participants|||Number
773771|NCT00742313|Primary|Number of Participants With Decreased Bleeding|The number of participants with less than expected bleeding (bleeding typically expected for the vein grafting procedure) at the surgical site. Blood was collected in the Blake drain of the EVH wound bed treated with FloSeal MatrixFloSeal Matrix™in the tunnel of the endoscopically harvested Greater Saphenous vein.|14 days|Six participants were not analyzed due to early termination of study||participants|||Number
773772|NCT00742326|Secondary|Change in Insulin Resistance in HIV- and HCV-infected Patients With Steatosis Compared to Placebo|Change in Glucose Area Under the Curve from standard oral glucose challenge ( baseline to 2 hours): Week 48 - Baseline values|48 weeks|One subject in the placebo arm was discontinued due to health issues and does not have a 48 week OGTT available||mg*120 minutes/dL||Standard Deviation|Mean
773773|NCT00742326|Primary|Change in Hepatic Steatosis and Hepatic Inflammation/Fibrosis in HIV/HCV Co-infected Patients With Steatosis.|Change in hepatic steatosis and hepatic inflammation/fibrosis in HIV/HCV co-infected patients with steatosis. Change in Hepatic Fat Content measured by MR spectroscopy: 48 weeks compared to Baseline|48 weeks|Two subjects (one in each group) did not have a follow up MRI for comparision to baseline. One developed claustrophobia and could not tolerate MRI and one was discontinued from study due to other illnesses.||percentage of hepatic fat on MRS||Standard Deviation|Mean
773774|NCT00742391|Secondary|Patients With Partial Clearance of Actinic Keratosis (AKs)|Partial clearance rate of AK lesions defined as the proportion of patients with a 75% or greater reduction in the number of actinic keratosis (AK) lesions identified at baseline in the selected treatment area.|baseline and 57 days|Intention to treat population||participants|||Number
773775|NCT00742391|Primary|Patients With Complete Clearance of Actinic Keratosis (AKs)|Complete clearance rate of actinic keratosis (AK) lesions defined as the proportion of patients with no clinically visible AK lesions in the selected treatment area.|57 days|Intention to treat population||Participants|||Number
773776|NCT00742417|Secondary|Variations in Hypoperfusion Based on Single Photon Emission Computed Tomography (SPECT)|Percentage of patients with improved perfusion at the end of the study compared to their initial perfusion. Frontal, parietal and temporal lobes were evaluated from the quantified NeuroGam images. This rendered parametric images showed brain alterations with more than 2 standard deviations with respect to a normal data base. Initial parametric images were compared to the final ones and it was considered perfusion improvement those patients that showed less stretch and/or defect intensity.|End of study|We analyzed two groups of patients, a treatment group of 20 patients, and a control group, also of 20 patients||percentage of participants|||Number
773777|NCT00742417|Secondary|Magnetic Resonance Imaging (MRI) Structural Changes Variations Versus Baseline.|Structural changes in volume of the hippocampus, posterior cingular area, and other associated areas by Magnetic Resonance Imaging (MRI). Three measurements were made (week -2 or -1, 20 and 44). It was measured the variations versus the baseline.|Week 00 (baseline), week 20 and week 44|We analyzed two groups of patients, a treatment group of 20 patients, and a control group, also of 20 patients||cubic centimetres (cc)||Standard Deviation|Mean
773797|NCT00742508|Primary|Mean Change From Baseline in Mean Corpuscular Hemoglobin at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.||picograms (pg)||Standard Deviation|Mean
773778|NCT00742417|Secondary|Change From Baseline to Week 44 in Cognitive, Functional and Neuropsychiatric Scores (ADCS-ADL, NPI, CDR-Sb and ADCS-CGIC).|"Change in the cognitive, functional and neuropsychiatric scores and overall development.
ADCS-ADL: Alzheimer’s Disease Cooperative Study/Activities Of Daily Living (23 questions describing daily activity of the subject and requests the informer to describe the actions or behaviors observed. Increased autonomy associated to higher scores, maximum of 78 points and minimum of 0)
NPI: Neuropsychiatric Inventory Questions (12 symptom domains scored by frequency [range=0 to 4, higher values being more frequent] and severity [range=1 to 3, higher values being more severe], total score is sum of frequency x severity of all domains)
CDR-Sb: Clinical Dementia Rating (range=0 to 3, higher values being more severe)
ADCS-CGIC: Alzheimer’s Disease Cooperative Study/Clinical Global Impression of Change (7-point Likert scale, 0=not assessed, 1=marked improvement, 2=moderate improvement, 3=minimal improvement, 4=no change, 5=minimal worsening, 6=moderate worsening and 7=marked worsening)"|Change from baseline at week 44|The efficacy analyses were performed with the FAS population which was defined as the set of subjects who were randomized, and received at least three plasma exchange sessions during the intensive treatment phase (the three first weeks of treatment).||units on a scale||Standard Deviation|Mean
773779|NCT00742417|Secondary|Change From Baseline to Week 44 in Cognitive, Functional and Neuropsychiatric Scores (MMSE, ADAS-Cog, NPS Battery and CSDD)|"Change in the cognitive, functional and neuropsychiatric scores and overall development.
MMSE: Mini Mental State Examination Score (range = 0 to 30, with lower values indicating impairment)
ADAS-Cog: Alzheimer’s Disease Assessment Scale, Cognitive Subscale (range = 0 to 70, with higher values indicating impairment)
NPS (Neuropsychological battery): •SDMT (Symbol Digit Modalities Test, range = 0 to 110, with lower values indicating impairment), •SVF (Semantic Verbal Fluency Test, with a maximum of 44 words in 60 seconds), •PVF F, A and S (Phonetic Verbal Fluency Test, with a maximum of 44 words in 60 seconds), •BNT (Boston Naming Test, with a maximum of 15 pictures), •RAVLT (Rey Auditory Verbal Learning Test, with 15 words the patient should listen and remind)
CSDD (Cornell Scale for Depression in Dementia, 0 = none; 1 =mild or intermittent; 2 = severe)"|Change from baseline at week 44|The efficacy analyses were performed with the FAS population which was defined as the set of subjects who were randomized, and received at least three plasma exchange sessions during the intensive treatment phase (the three first weeks of treatment).||units on a scale||Standard Deviation|Mean
773780|NCT00742417|Secondary|Aβ1−42 Plasma Levels Before and After Each Study Period (Innotest).|Plasma levels of Aβ1−42 before and after the Intensive period, Maintenance period I, Maintenance period II and the Follow-up phase (using Innotest commercial kits).|Baseline, pre-plasma exchange 1 (PRE-PE1), post-plasma exchange 6 (POST-PE6), pre-plasma exchange 7 (PRE-PE7), post-plasma exchange 12 (POST-PE12), pre-plasma exchange 13 (PRE-PE13), post-plasma exchange 18 (POST-PE18), week 33 and week 44.|The efficacy analyses were performed with the FAS population which was defined as the set of subjects who were randomized, and received at least three plasma exchange sessions during the intensive treatment phase (the three first weeks of treatment).||pg/mL||Standard Deviation|Mean
773781|NCT00742417|Secondary|Aβ1−42 Plasma Levels Before and After Each Study Period (The Genetics Company).|Plasma levels of Aβ1−42 before and after the Intensive period, Maintenance period I, Maintenance period II and the Follow-up phase (using The Genetics Company commercial kits).|Baseline, pre-plasma exchange 1 (PRE-PE1), post-plasma exchange 6 (POST-PE6), pre-plasma exchange 7 (PRE-PE7), post-plasma exchange 12 (POST-PE12), pre-plasma exchange 13 (PRE-PE13), post-plasma exchange 18 (POST-PE18), week 33 and week 44|The efficacy analyses were performed with the FAS population which was defined as the set of subjects who were randomized, and received at least three plasma exchange sessions during the intensive treatment phase (the three first weeks of treatment).||pg/mL||Standard Deviation|Mean
773782|NCT00742417|Secondary|Aβ1−40 Plasma Levels Before and After Each Study Period (The Genetics Company).|Plasma levels of Aβ1−40 before and after the Intensive period, Maintenance period I, Maintenance period II and the Follow-up phase (using The Genetics Company commercial kits).|Baseline, pre-plasma exchange 1 (PRE-PE1), post-plasma exchange 6 (POST-PE6), pre-plasma exchange 7 (PRE-PE7), post-plasma exchange 12 (POST-PE12), pre-plasma exchange 13 (PRE-PE13), post-plasma exchange 18 (POST-PE18), week 33 and week 44.|The efficacy analyses were performed with the FAS population which was defined as the set of subjects who were randomized, and received at least three plasma exchange sessions during the intensive treatment phase (the three first weeks of treatment).||pg/mL||Standard Deviation|Mean
773783|NCT00742417|Secondary|P-Tau and Tau CSF Levels Throughout the Study.|Levels of Tau and P-tau in CSF throughout the treatment phase and the follow-up phase (week 44).|Baseline, week 02, week 08, week 20, week 33 and week 44|The efficacy analyses were performed with the FAS population which was defined as the set of subjects who were randomized and received at least three plasma exchange sessions during the intensive treatment phase (the three first weeks of treatment).||pg/mL||Standard Deviation|Mean
773784|NCT00742417|Primary|Change From Baseline in Aβ1-42 Cerebrospinal Fluid (CSF) Levels.|Change in levels of Aβ1-42 in CSF in the period between baseline lumbar puncture (before the start of treatment) and lumbar puncture immediately after the end of the last plasma exchange (whenever this may be). Separate assays of Aβ1-42 were performed with Innotest and The Genetics Company commercial kits.|Baseline and up to week 44|The efficacy analyses were performed with the full analysis set (FAS) population which was defined as the set of subjects who were randomized, and received at least three plasma exchange sessions (or sham procedures) during the intensive treatment phase (the three first weeks of treatment).||pg/mL||95% Confidence Interval|Least Squares Mean
773785|NCT00742508|Secondary|Echocardiogram Results: Left Ventricular Ejection Fraction at Baseline and Week 8|Left ventricular ejection fraction (LVEF) is a marker of left ventricular systolic function and was measured by echocardiogram. It is shown as the ratio of left ventricular stroke volume (LVSV) to left ventricular end-diastolic volume (LVEDV), and is measured as a percentage.|Baseline and Week 8|Efficacy Population: all participants measurable at the efficacy endpoints (20 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group). Some participants in each treatment arm withdrew prematurely.||percentage||Standard Deviation|Mean
773798|NCT00742508|Primary|Mean Change From Baseline in Red Blood Cell Count at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.||tebi (2 to the power of 40)/liter (Ti/L)||Standard Deviation|Mean
773786|NCT00742508|Secondary|Mean Plasma Brain Natriuretic Peptide Concentration at Baseline and Week 8|Brain natriuretic peptide is a surrogate marker of the severity of heart failure and was measured by a central laboratory.|Baseline and Week 8|Efficacy Population: all participants measurable at the efficacy endpoints (20 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group). Some participants in each treatment arm withdrew prematurely.||ng/L (nanogram per Liter)||Standard Deviation|Mean
773787|NCT00742508|Secondary|Number of Participants With the Indicated Change From Baseline New York Heart Association (NYHA) Functional Class at Week 8|The NYHA classification assesses the severity of symptoms of heart failure as judged by the investigator and is comprised of. 4 classes: I, no resulting limitations on physical activity (PA); II, slight limitations on PA; III, marked limitations on PA; IV, inability to carry out any PA without discomfort. The number of participants with any change from Baseline in the NYHA Functional Class at Week 8 was calculated. Improved=class at the visit is decreased compared to baseline class, Unchanged=class at the visit is stable, Worsened=class at the visit is increased compared to baseline class.|Baseline and Week 8|Efficacy Population: all participants measurable at the efficacy endpoints (20 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.||participants|||Number
773788|NCT00742508|Secondary|Adjusted Mean Change From Baseline in Mean Heart Rate at Week 8|Pharmacodynamic (PD) assessment points were 24 hours (h) (from time of first reading to time of last reading), morning (6 am-12 pm), afternoon (12-6 pm), night (6 pm-6 am on following day), waking (8 am-9 pm), sleeping (0-5 am), PDmax (maximal value obtained with each participant during the 0-24 h interval), PDmin (minimal value obtained with each participant during the 0-24 h interval), and PDmax/PDmin. PDmax/PDmim was calculated as the ratio of the PDmax to PDmin, and it showed the degree of change during the 0-24 h interval. The mean was adjusted for Baseline value.|Baseline and Week 8|PD Population: all participants measurable at the PD endpoints (18 participants at baseline and 3 participants at Week 8 in CRV-IR group, 19 participants at baseline and 4 participants at Week 8 in SK&F-105517-D group)||beats per minute||Standard Error|Mean
773789|NCT00742508|Secondary|Adjusted Mean Change From Baseline in Diastolic Blood Pressure at Week 8|Pharmacodynamic (PD) assessment points were 24 hours (h) (from time of first reading to time of last reading), morning (6 am-12 pm), afternoon (12-6 pm), night (6 pm-6 am on following day), waking (8 am-9 pm), sleeping (0-5 am), PDmax (maximal value obtained with each participant during the 0-24 h interval), PDmin (minimal value obtained with each participant during the 0-24 h interval), and PDmax/PDmin. PDmax/PDmim was calculated as the ratio of the PDmax to PDmin, and it showed the degree of change during the 0-24 h interval. The mean was adjusted for Baseline value.|Baseline and Week 8|Pharmacodynamic (PD) Population: all participants measurable at the PD endpoints (18 participants at baseline and 3 participants at Week 8 in CRV-IR group, 19 participants at baseline and 4 participants at Week 8 in SK&F-105517-D group)||millimeters of mercury (mmHg)||Standard Error|Mean
773790|NCT00742508|Primary|Cardiothoracic Ratio at Baseline and Week 8|Cardiothoracic ratio is a marker of the degree of heart enlargement and was measured by chest X-ray. It is shown as the ratio of the transverse diameter of the heart to the transverse diameter of the thorax, and is measured as a percentage.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.||percentage||Standard Deviation|Mean
773791|NCT00742508|Primary|Number of Participants With the Indicated Electrocardiogram Findings at Baseline and Week 8|There are 3 categories for electrocardiogram (ECG) findings: normal; abnormal, not clinically significant; and abnormal, clinically significant. Each of the findings was classified by the investigator according to whether it was normal. Abnormal ECGs were further classified according to whether they were felt to be clinically significant in the medical and scientific judgment of the investigator.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.||participants|||Number
773792|NCT00742508|Primary|Mean Change From Baseline in Weight at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.||kilograms (kg)||Standard Deviation|Mean
773793|NCT00742508|Primary|Mean Change From Baseline in Heart Rate at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.||beats per minute||Standard Deviation|Mean
773794|NCT00742508|Primary|Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.||millimeters of mercury (mmHg)||Standard Deviation|Mean
773795|NCT00742508|Primary|Number of Participants With the Indicated Urinalysis Dipstick Results at Baseline and Week 8|Dipstick test values: Negative (-), Traces (+-), +1, +2, +3. +4. Normal ranges (qualitative): protein, - or +-; glucose, - or +-; occult blood, -; ketones, -.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.||participants|||Number
773796|NCT00742508|Primary|Mean Change From Baseline in Mean Corpuscular Volume at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.||femtoliters (fL)||Standard Deviation|Mean
773799|NCT00742508|Primary|Mean Change From Baseline in Platelet Count and White Blood Cell Count at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.||gibi (2 to the power of 30)/liter (Gi/L)||Standard Deviation|Mean
773800|NCT00742508|Primary|Mean Change From Baseline in Hematocrit at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.||proportion of 1 (SI)||Standard Deviation|Mean
773801|NCT00742508|Primary|Mean Change From Baseline in Hemoglobin and Mean Corpuscular Hemoglobin Concentration at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.||grams per liter (g/L)||Standard Deviation|Mean
773802|NCT00742508|Primary|Mean Change From Baseline in Each Type of White Blood Cell (WBC) (Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils) at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.||percentage of each WBC type in WBC count||Standard Deviation|Mean
773803|NCT00742508|Primary|Mean Change From Baseline in Creatine Kinase BB Percentage, Creatine Kinase MB Percentage, and Creatine Kinase MM Percentage at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value. (BB, brain-derived; MB=cardiac muscle-derived; MM=skeletal muscle-derived.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.||percentage of Total Creatine Kinase||Standard Deviation|Mean
773804|NCT00742508|Primary|Mean Change From Baseline in Calcium, Chloride, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.||millimoles per liter (mmol/L)||Standard Deviation|Mean
773805|NCT00742508|Primary|Mean Change From Baseline in Total Bilirubin, Creatinine, and Uric Acid at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.||micromoles per liter (umol/L)||Standard Deviation|Mean
773806|NCT00742508|Primary|Mean Change From Baseline in Amylase at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.||units per liter (U/L)||Standard Deviation|Mean
773807|NCT00742508|Primary|Mean Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Creatine Kinase, and Gamma Glutamyl Transferase at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.||international units per liter (IU/L)||Standard Deviation|Mean
773808|NCT00742508|Primary|Mean Change From Baseline in Albumin and Total Protein at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.||grams per liter (g/L)||Standard Deviation|Mean
773809|NCT00742508|Secondary|Adjusted Mean Change From Baseline in Systolic Blood Pressure at Week 8|Pharmacodynamic (PD) assessment points were 24 hours (h) (from time of first reading to time of last reading), morning (6 am-12 pm), afternoon (12-6 pm), night (6 pm-6 am on following day), waking (8 am-9 pm), sleeping (0-5 am), PDmax (maximal value obtained with each participant during the 0-24 h interval), PDmin (minimal value obtained with each participant during the 0-24 h interval), and PDmax/PDmin. PDmax/PDmim was calculated as the ratio of the PDmax to PDmin, and it showed the degree of change during the 0-24 h interval. The mean was adjusted for Baseline value.|Baseline and Week 8|Pharmacodynamic (PD) Population: all participants measurable at the PD endpoints (18 participants at baseline and 3 participants at Week 8 in CRV-IR group, 19 participants at baseline and 4 participants at Week 8 in SK&F-105517-D group)||millimeters of mercury (mmHg)||Standard Error|Mean
773810|NCT00742508|Secondary|Time of Maximal Plasma Concentration (Tmax) of S-carvedilol, R-carvedilol, and M4 Active Metabolite (SB-203231) at Week 8|Time of maximal plasma concentration (tmax) of S-carvedilol, R-carvedilol, and M4 active metabolite (SB-203231) was measured. Participants in each treatment group were divided into 3 groups by pharmacokinetic sampling timing: Groups A, B, and C in the SK&F-105517-D group and Groups D, E, and F in the CRV-IR group. Carvedilol is a racemic mixture. Non-selective β-blocking activity is shown by S-carvedilol, while α1-blocking activity is shown by both S-carvedilol and R-carvedilol.|Week 8|PK Parameter Population: total of 13 participants, including 3 in group F who gave samples at Week 8 in the CRV-IR group; total of 15 participants, including 4 in group C who gave samples at Week 8 in the SK&F-105517-D group||hours||Full Range|Median
773847|NCT00742924|Secondary|Event-free Survival|The EFS and survival functions will be estimated by the Kaplan-Meier methodology.|Time from study enrollment to disease recurrence, death without disease progression, diagnosis of a second malignant neoplasm, assessed up to 5 years||||||
773811|NCT00742508|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours (AUC0-24) of S-carvedilol, R-carvedilol, and M4 Active Metabolite (SB-203231) at Week 8|Area under the plasma concentration versus time curve from time zero to 24 hours (AUC0-24) of S-carvedilol, R-carvedilol, and M4 active metabolite (SB-203231) was measured. Participants in each treatment group were divided into 3 groups by pharmacokinetic sampling timing: Groups A, B, and C in the SK&F-105517-D group and Groups D, E, and F in the CRV-IR group. The analysis was performed on log-transformed data. Carvedilol is a racemic mixture. Non-selective β-blocking activity is shown by S-carvedilol, while α1-blocking activity is shown by both S-carvedilol and R-carvedilol.|Week 8|Pharmacokinetic (PK) Parameter Population: all participants who received the study drug at each dose level and provided sufficient PK concentration data and the data for estimation of PK parameters (total of 13 participants, 3 gave samples at Week 8 in CRV-IR group; total of 15 participants, 4 gave samples at Week 8 in the SK&F-105517-D group)||hours * nanograms per milliliter (ng/mL)||95% Confidence Interval|Geometric Mean
773812|NCT00742508|Secondary|Maximum Plasma Concentration (Cmax) and Trough Plasma Concentration (Cmin) of S-carvedilol, R-carvedilol, and M4 Active Metabolite (SB-203231) at Week 8|Maximum Plasma Concentration (Cmax) and Trough Plasma Concentration (Cmin) of S-carvedilol, R-carvedilol, and M4 active Metabolite (SB-203231) were measured. Participants in each treatment group were divided into 3 groups by pharmacokinetic sampling timing: Groups A, B, and C in the SK&F-105517-D group and Groups D, E, and F in the CRV-IR group. The analysis was performed on log-transformed data. Carvedilol is a racemic mixture. Non-selective β-blocking activity is shown by S-carvedilol, while α1-blocking activity is shown by both S-carvedilol and R-carvedilol.|Week 8|PK Parameter Population: total of 13 participants, including 3 who gave samples in group F at Week 8 in CRV-IR group; total of 15 participants, including 4 who gave samples at Week 8 in the SK&F-105517-D group)||nanograms per milliliter (ng/mL)||95% Confidence Interval|Geometric Mean
773813|NCT00742508|Primary|Number of Participants With Adverse Events by Severity From Week 0 Through Week 8 (CRV-IR) or Week 14 (SK&F-105517-D)|Drug-related adverse events (AEs) were defined as AEs that were judged to have a relationship with the investigational product by the investigator (or subinvestigator) with the use of clinical judgment and the Clinical Investigator Brochure to determine the relationship. Refer to adverse event information for type and frequency of adverse events.|Treatment Period from Week 0 (Baseline) to Week 8 and 1-week Follow-up Period (Week 9) for CRV-IR; Treatment Period from Week 0 (Baseline) to Week 14 and 1-week Follow-up Period (Week 15) for SK&F-105517-D|Safety Population: all participants who received at least one dose of the investigational product||participants|||Number
773814|NCT00742625|Secondary|Overall Survival|Overall survival (OS) as the interval from the on-study date until death. OS was estimated using the Kaplan Meier method.|Duration of study (up to 10 years)|||months||95% Confidence Interval|Median
773815|NCT00742625|Secondary|Disease-free Survival|Disease-free survival (DFS) was measured as the interval from achievement of CR until relapse or death, regardless of cause. DFS was estimated using the Kaplan Meier method.|Duration of study (up to 10 years)|||months||95% Confidence Interval|Median
773816|NCT00742625|Primary|Participants Experiencing a Dose-limiting Toxicity (DLT) of Bortezomib When Administered in Combination With Intermediate-dose Cytarabine|"DLTs were considered only during the first cycle of consolidation therapy and included grade 3 or 4 sensory or autonomic neuropathy, persistent grade 4 thrombocytopenia or neutropenia at day 42 in the absence of AML,any grade 4 or 5 nonhematologic toxicity, and any grade 3 nonhematologic toxicity (excluding neuropathy and toxicities secondary to neutropenia and sepsis) that did not resolve to grade 2 by day 42 unless attributable to persistent or recurrent AML. Grade 4 anorexia (requiring total parenteral nutrition) and grade 4 fatigue (requiring bed rest) were not considered DLTs.
Toxicity was graded per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Grading scale is as follows: grade 1: mild; grade 2: moderate; grade 3: Severe; grade 4: Life Threatening; grade 5: Death."|during consolidation cycle 1 (42 days)|Participants who were registered to bortezomib consolidation were included in the analysis.||participants|||Number
773817|NCT00742625|Primary|Remission Induction Response|"Response was calculated according to Revised International Working Group (IWG) criteria for Acute myeloid leukemia (AML)
A response was defined as the portion of participants who achieved a complete response (CR) or CR with incomplete platelet recovery(CRp) during induction.
A CR is defined as those with > 20% cellularity of bone marrow biopsy, no presence of extramedullary leukemia for AML, <5 % myeloblast cells for bone marrow with peripheral blood and normal complete blood count (absolute neutrophils > 1000 mL and platelets >= 100,000 mL).
A CRp is defined as a CR except platelets < 100,000 mL without need for transfusion."|2 months|||participants|||Number
773818|NCT00742781|Primary|25(OH)D3 Serum Levels|25(OH)D3 levels before and after vitamin D supplementation.|6 months|||ng/ml 25(OH)D3||Standard Error|Mean
773819|NCT00742781|Secondary|Health Improvement|International Physical Activity Questionnaire. Minutes/week for 30 min/day, 5days (MET) are calculated for different activity intensities. Total range of scores 0-600 MET low activity, 600-1200 Moderate activity, Over 1200-3000 High activity.|6 months|Activity records for 14 participants were recorded at baseline and after vitamin D supplementation.||units on a scale||Standard Error|Mean
773820|NCT00742781|Primary|Crohn's Disease Activity Index|Questionnaire and physical measurements combine to generate a score. Scores below 150 indicate remission, 150-350 mild to moderate disease, over 350 severe disease. The total range of scores are from 0- Don't have Crohn's disease to 600 severe Crohn's disease. 0-150 is remission, 151-219 is mild, 220-450 is moderate disease and over 451 is severe.|6 months|||units on a scale||Standard Error|Mean
773898|NCT00736944|Secondary|Disease Free Survival|Time from complete response to death from any cause, to disease progression or to last follow-up alive.|10 years from completion of treatment||08/2020||||
773899|NCT00736944|Secondary|Overall Survival|Time from diagnosis to death or to last follow-up alive.|10 years from completion of treatment||08/2020||||
773823|NCT00742872|Primary|Adequate Relief of Symptoms Associated With Constipation-predominant Irritable Bowel Syndrome.||Within the first 8 weeks of treatment|||participants|||Number
773824|NCT00742885|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the entire study period (Day 0 to Day 181)|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.||Subjects|||Number
773825|NCT00742885|Secondary|Number of Subjects Reporting Any Medically-significant Conditions (MSCs)|MSCs were defined as AEs with a medically-attended visit (s) i.e. prompting emergency room (ER) visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination.|During the 182-day (Days 0-181) post-vaccination period|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.||Subjects|||Number
773826|NCT00742885|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs|Unsolicited AE is any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.|From Day 0 to Day 83 following vaccination|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.||Subjects|||Number
773827|NCT00742885|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|Unsolicited AE is any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.|During the 21-day (Days 0-20) following vaccination|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.||Subjects|||Number
773828|NCT00742885|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms assessed were fatigue, headache, joint pain, muscle aches, shivering, increase sweating and fever. Any=any solicited general symptom reported regardless of their intensity grade or their relationship to vaccination. Any fever was ≥ 38.0 degrees celsius (°C). Grade 3 = general symptom that prevented normal everyday activities as assessed by inability to attend/do work or school, or required intervention of a physician/healthcare provider. Grade 3 fever was≥ 39.0°C. Related= general symptom assessed by the investigator as causally related to the study vaccination.|During the 7-day post vaccination period (Days 0-6) after any vaccination|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.||Subjects|||Number
773829|NCT00742885|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling/induration. Any=any solicited local symptom reported regardless of their intensity. Grade 3 pain= significant pain at rest that prevented normal activities as assessed by inability to attend/do work or school. Grade 3 redness and swelling/induration=redness and swelling/induration above 100 millimetres (mm).|During the 7-day post vaccination period (Days 0-6) after any vaccination|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.||Subjects|||Number
773830|NCT00742885|Secondary|Number of Subjects With Any Normal or Abnormal Urine Values|Urine parameters assessed were blood, glucose, protein and urobilinogen. Categories = negative, positive|At Day 0, Day 7 and Day 42|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.||Subjects|||Number
773831|NCT00742885|Secondary|Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities|"Biochemical and haematological parameters assessed in blood samples include lymphocytes (LYM), monocytes (MON) and neutrophils (NEU).
Categories = unknown, below, within, or above the normal ranges."|At Day 0, Day 7 and Day 42|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.||Subjects|||Number
773832|NCT00742885|Secondary|Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities|"Biochemical and haematological parameters assessed in blood samples include lymphocytes (LYM), monocytes (MON) and neutrophils (NEU).
Categories = unknown, below, within, or above the normal ranges."|At Day 0, Day 7 and Day 42|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.||Subjects|||Number
773833|NCT00742885|Secondary|Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities|"Biochemical and haematological parameters assessed in blood samples include creatinine (CREA), eosinophils (EOS), hemoglobin (HB) and hematocrit (HC).
Categories = unknown, below, within, or above the normal ranges."|At Day 0, Day 7 and Day 42|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.||Subjects|||Number
773834|NCT00742885|Secondary|Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities|Biochemical and haematological parameters assessed in blood samples include alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS) and blood urea nitrogen (BUN ). Categories = unknown, below, within, or above the normal ranges.|At Day 0, Day 7 and Day 42|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.||Subjects|||Number
773835|NCT00742885|Secondary|Number of Subjects Seroconverted for Serum Anti-H5N1 Neutralising Antibodies|"A seroconverted subject was defined as a subject with a minimum 4 fold increase in titer at post-vaccination for neutralising antibody response at Days 42 and 182.
The H5N1 vaccine strain included A/Indonesia antigen."|At Day 42 and Day 182|Analysis was performed on According-To-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component on Day 182.||Subjects|||Number
773836|NCT00742885|Secondary|Antibody Titers for Serum Anti-H5N1 Neutralising Antibodies|Antibody titers were expressed as Geometric mean titers (GMTs). The H5N1 vaccine strain included A/Indonesia antigen.|At Day 0, Day 42 and Day 182|Analysis was performed on According-To-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component on Day 182.||Titer||95% Confidence Interval|Geometric Mean
773837|NCT00742885|Secondary|Number of Subjects Seroprotected for H5N1 HI Antibodies|A seroprotected subject was defined as a subject with a serum H5N1 HI antibody titer greater than or equal to 1:40, at Days 21 and 182. The H5N1 vaccine strain included A/Indonesia antigen.|At Day 0, Day 21 and Day 182|Analysis was performed on According-To-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component on Day 182.||Subjects|||Number
773838|NCT00742885|Secondary|Seroconversion Factors for H5N1 HI Antibodies|Seroconversion factors (SCF) were defined as the fold increase in serum H5N1 HI antibody GMTs post-vaccination compared to Day 0, at Days 21 and 182. The H5N1 vaccine strain included A/Indonesia antigen.|At Day 21 and Day 182|Analysis was performed on According-To-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component on Day 182.||Fold Increase||95% Confidence Interval|Geometric Mean
773839|NCT00742885|Secondary|Number of Subjects Seroconverted for H5N1 HI Antibodies|A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer, at Days 21 and 182. The H5N1 vaccine strain included A/Indonesia antigen.|At Day 21 and Day 182|Analysis was performed on According-To-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component on Day 182.||Subjects|||Number
773840|NCT00742885|Primary|Haemagglutination Inhibition (HI) Antibody Titers for the H5N1 Vaccine Strain|Antibody titers were expressed as Geometric mean titers (GMTs). The H5N1 vaccine strain included A/Indonesia antigen.|At Day 0, Day 21 and Day 182|Analysis was performed on According-To-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component on Day 182.||Titer||95% Confidence Interval|Geometric Mean
773841|NCT00742885|Primary|Number of Subjects Seroprotected for H5N1 HI Antibodies|A seroprotected subject was defined as a subject with a serum H5N1 HI antibody titer greater than or equal to 1:40, at Day 42. The H5N1 vaccine strain included A/Indonesia antigen.|At Day 42|Analysis was performed on According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component after vaccination.||Subjects|||Number
773842|NCT00742885|Primary|HI Antibody Seroconversion Factors for H5N1 HI Antibodies|Seroconversion factors (SCF) were defined as the fold increase in serum H5N1 HI antibody GMTs post-vaccination compared to Day 0, at Day 42. The H5N1 vaccine strain included A/Indonesia antigen.|At Day 0 and Day 42|Analysis was performed on According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component after vaccination.||Fold Increase||95% Confidence Interval|Geometric Mean
773843|NCT00742885|Primary|Number of Subjects Seroconverted for H5N1 HI Antibodies|A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. The H5N1 vaccine strain included A/Indonesia antigen.|At Day 42|Analysis was performed on According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component after vaccination.||Subjects|||Number
773844|NCT00742885|Primary|Haemagglutination Inhibition (HI) Antibody Titers for the H5N1 Vaccine Strain|Antibody titers were expressed as Geometric mean titers (GMTs). The H5N1 vaccine strain included A/Indonesia/05/2005 antigen (A/Indonesia).|At Day 0 and Day 42|Analysis was performed on According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component after vaccination.||Titer||95% Confidence Interval|Geometric Mean
773845|NCT00742924|Secondary|Prognostic Value of Bone Resorption Markers|Blood will be collected for quantification of c-telopeptide and urine will be collected for quantification of n-telopeptide.|At baseline and at weeks 13 and 36||||||
773846|NCT00742924|Secondary|Secondary Limiting Toxicity|"Secondary limiting toxicity defined as Any CTC AE version 4 Grade 3 and 4 non-hematologic toxicity thought to be possibly, probably or definitely related to zoledronic acid with the specific exclusion of:
Grade 3 nausea and vomiting controlled with adequate antiemetic prophylaxis.
Grade 3 transaminase (AST/ALT) that occurs during the evaluation period but resolves to ≤ Grade 2, before the planned dose of therapy after definitive surgery.
Grade 3 fever or infection.
Grade 3 or 4 hypocalcemia (see Section 5.1.1)
Grade 3 mucositis.
Grade 3 fatigue that returns to ≤ Grade 2, before the planned dose of therapy after definitive surgery.
Grade 3 joint range of motion, decreased or joint effusion that is related to the primary tumor.
CTC AE version 4 hematologic toxicity will be based on time to blood count recovery to an ANC ≥ 1000/µL and platelet count ≥ 100,000/µL that delays definitive surgery by more than 2 weeks."|After week 13 to the end of protocol therapy||||||
773848|NCT00742924|Secondary|Histologic Response as Assessed in the Primary Tumor and in Resected Metastases|"Histologic response as graded according to the system of Huvos across all specimens resected at the time of local control in the primary tumor and in resected metastases.
The best response, as quantified by maximum necrosis grading according to the system of Huvos across all specimens resected at the time of local control, will be used to quantify the effect of Induction chemotherapy."|At definitive surgery planned for 12 weeks after the start of protocol therapy.||||||
773849|NCT00742924|Primary|Limiting Toxicity|"The occurrence of Limiting Toxicity defined as Any CTC AE version 4 Grade 3 and 4 non-hematologic toxicity thought to be possibly, probably or definitely related to zoledronic acid with the specific exclusion of:
Grade 3 nausea and vomiting controlled with adequate antiemetic prophylaxis.
Grade 3 transaminase (AST/ALT) that occurs during the evaluation period but resolves to ≤ Grade 2, before the planned dose of therapy after definitive surgery.
Grade 3 fever or infection.
Grade 3 or 4 hypocalcemia (see Section 5.1.1)
Grade 3 mucositis.
Grade 3 fatigue that returns to ≤ Grade 2, before the planned dose of therapy after definitive surgery.
Grade 3 joint range of motion, decreased or joint effusion that is related to the primary tumor."|Enrollment through the first 12 weeks of therapy.|Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome||participants|||Number
773851|NCT00743093|Secondary|The Proportion of Subjects With Detectable Serum Acetaminophen-cysteine Adduct (APAP-cys) Concentrations 1, 2, and 3 Days After Starting the Maximal Recommended Dosing of Acetaminophen (4 g/Day).||Days 1-3|A subset of the safety population was monitored for early detection of APAP-cys. This subset of subjects had APAP-cys measured at Days 1, 2, and 3 in addition to other protocol defined timepoints.||participants|||Number
773852|NCT00743093|Primary|The Proportion of Subjects Treated With Long-term Acetaminophen (4 g/Day) That Develops Persistent ALT Elevations.|ALT was measured on Day 0 and 16 for all study participants. Subjects with an elevated ALT at Day 16 continued dosing with study drug and continued to have their ALT measured every three days until the ALT elevation resolved or until Day 40. Persistent ALT elevation was defined as any subject with an unresolved ALT elevation at study Day 40.|serial samples for 16-40 days|The total number of subjects completing the trial was used for analysis. Subjects who withdrew early were not included.||participants|||Number
773853|NCT00743106|Secondary|To Evaluate the Effects of Lateral Flexion on Patient Hemodynamic Changes as Well as EKG Changes in the Operating Room.||6 weeks post-operatively||||||
773854|NCT00743106|Primary|Glomerular Filtration Rate (GFR) Percentage of Change From Baseline|Our intended primary analysis was to assess the effect of fenoldopam vs placebo on the GFR at post-operative day (POD) 3 with an analysis of covariance adjusting for the baseline GFR. However, because the intervention-by-baseline GFR interaction using GFR at POD 3 as the outcome was significant (P ¼ .006), the analysis of covariance was not valid. We, therefore, used the GFR percentage of change from baseline to POD 3 as the primary outcome.|percentage of change from baseline to post-operatively day 3|||percentage change||Standard Deviation|Mean
773855|NCT00743197|Secondary|The Role and Function of Endothelial Progenitor Cells (EPCs) in the Presence of Proven Endothelial Dysfunction and the Response of EPCs to Medical Therapy for Endothelial Dysfunction.|no analyses were conducted due to the PI's departure from the institution; all work including analyses ceased upon departure- the study was not transferred with the PI. In addition, the study end points were based on changes between groups (treatment vs. usual care group) at 12 month follow up for both groups - none of the enrolled subjects made it to the final (month 12) visit.|1 year||||||
773856|NCT00743197|Primary|Effectiveness of Therapy Compared to Usual Care, in Those Women With Chest Pain (CP), Reversible Ischemia by Stress Testing and Nonobstructive Coronary Artery Disease (CAD) by Angiography Who Are Found to Have Coronary Endothelial Dysfunction (CED).|The purpose of this study is to compare the effectiveness of standard medical therapy versus usual care in women with chest pain (CP), coronary endothelial dysfunction (CED) and unblocked coronary arteries. CED is a condition in which the layers of cells around the heart do not function properly and is believed to be a key factor in the development of atherosclerosis (fat deposits in arteries). In addition, CED is associated with an increased risk for suture cardiovascular events, such as heart attack and stroke.|1 year|no analyses were conducted due to PI's departure from institution;all work including analyses ceased upon departure-the study was not transferred with the PI. In addition, study end points were based on changes between groups (treatment vs. usual care)at 12-mo follow up for both groups- none of the enrolled subjects completed the month 12 visit.||participants|||Number
773857|NCT00736580|Secondary|Surgeon Satisfaction by Likert Scale.||1 week||||||
773858|NCT00736580|Primary|Surgical Glove Perforation.|Direct measurement of the number of glove perforations listed by surgical case.|1 week|||Cases with a glove puncture|||Number
773859|NCT00736723|Primary|Pattern of NT-proBNP, Biomarkers and Surface Markers on Leukocytes|maximal NT-proBNP concentrations in critically ill surgical patients admitted from 01 July 2008 to 31 Dec 2008 in the ICU revealingnonseptic and septic shock|01 July 2008 to 31 Dec 2008|||pg/ml||Full Range|Median
773860|NCT00736840|Secondary|AUC of ROC (Area Under Receiver Operating Characteristic Curve)|The AUC represents a summary measure of the ROC curve and is the accuracy of the HIS in detecting cirrhosis compared to the gold standard of biopsy.|At study day 1 after 1 hour test|||Probability||95% Confidence Interval|Mean
773861|NCT00736840|Primary|"Number of Subjects With Likelihood of Cirrhosis Based on Hepatic Impairment Score (HIS)"|"Hepatic Impairment Score (HIS) is a score based on breath test parameters and demographic parameters of the subject being tested. A HIS value greater than 0.14 would mean that the subject is likely to be cirrhotic (based on biopsy result as the gold standard). The HIS is a probability score,i.e. ranges from 0 to 1, where 0 would mean the lowest probability of having liver cirrhosis and 1 would be the highest probability of having liver cirrhosis. This would be compared to the actual biopsy result of cirrhosis detection as the gold standard."|Study day 1 after a 1 hour test|The primary efficacy was conducted on all evaluable subject data in the full analysis (FA)set with biopsy confirmed cirrhosis.||Participants|||Number
773900|NCT00736944|Secondary|Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis||completion of the first 10 patients induction chemotherapy|||participants|||Number
773862|NCT00736853|Secondary|Change From Baseline in SF-36 at Day 28 of Double-Blind Period|The SF-36 is a survey of participant health and quality of life. It consists of 8 sub-scales, which are the weighted sums of the questions in their section. The 8 sub-scales are: physical functioning, role-physical, role-emotional, general health, social functioning, bodily pain, vitality, mental health. Each item is scored on a scale ranging from 0-100. Higher score defines a more favorable health status or a better mental status.|Day 1 and Day 28 of double-blind period|Efficacy analysis set included participants received at least one dose of the study drug. Here 'n' signifies number of participants evaluable at each time point for each arm respectively.||units on a scale||Standard Deviation|Mean
773863|NCT00736853|Secondary|Change From Baseline in Short Form-36 (SF-36) Score at Day 14 of Open-Label Period|The SF-36 is a survey of participant health and quality of life. It consists of 8 sub-scales, which are the weighted sums of the questions in their section. The 8 sub-scales are: physical functioning, role-physical, role-emotional, general health, social functioning, bodily pain, vitality, mental health. Each item is scored on a scale ranging from 0-100. Higher score defines a more favorable health status or a better mental status.|Day 1 and Day 14 of open-label period|Efficacy analysis set included who received at least one dose of study drug. Here 'n' signifies number of participants evaluable for this outcome measure at each time point.||units on a scale||Standard Deviation|Mean
773864|NCT00736853|Secondary|Change From Baseline in WOMAC Questionnaire Score at Day 28 of Double-Blind Period|The WOMAC questionnaire is an activity of daily living (ADL) indicator for knee osteoarthritis and designed to capture the elements of pain, stiffness, extent of obstruction to daily activities (EODA) and general index. The score for each element ranges from 0=better ADL to 10=worse ADL.|Day 1 and Day 28 of double-blind period|Efficacy analysis set included who received at least one dose of study drug and had the knee osteoarthritis as the target disease. Here 'n' signifies number of participants evaluable at each time point for each arm respectively.||units on a scale||Standard Deviation|Mean
773865|NCT00736853|Secondary|Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Questionnaire Score at Day 14 of Open-Label Period|The WOMAC questionnaire is an activity of daily living (ADL) indicator for Knee Osteoarthritis and designed to capture the elements of pain, stiffness, extent of obstruction to daily activities (EODA) and general index. The score for each element ranges from 0=better ADL to 10=worse ADL.|Day 1 and Day 14 of open-label period|Efficacy analysis set included who received at least one dose of study drug and had the knee osteoarthritis as the target disease. Here 'n' signifies number of participants evaluable for this outcome measure at each time point.||units on a scale||Standard Deviation|Mean
773866|NCT00736853|Secondary|Change From Baseline in RDQ Total Score at Day 28 of Double-Blind Period|The RDQ is self-administered measure of disability caused by low back pain and consists of 24 statements. The total score ranges from 0=no disability to 24=severe disability. The higher scores indicate greater physical disability.|Day 1 and Day 28 of double-blind period|Efficacy analysis set included participants received at least one dose of the study drug and had the lumbago as the target disease. Here 'n' signifies number of participants evaluable at each time point for each arm respectively.||units on a scale||Standard Deviation|Mean
773867|NCT00736853|Secondary|Change From Baseline in Roland Morris Disability Questionnaire (RDQ) Total Score at Day 14 of Open-Label Period|The RDQ is self-administered measure of disability caused by low back pain and consists of 24 statements. The total score ranges from 0=no disability to 24=severe disability. The higher scores indicate greater physical disability.|Day 1 and Day 14 of open-label period|Efficacy analysis set included who received at least one dose of study drug and had the lumbago as the target disease. Here 'n' signifies number of participants evaluable for this outcome measure at each time point.||units on a scale||Standard Deviation|Mean
773868|NCT00736853|Secondary|Sum of Pain Relief Combined With Pain Intensity Difference (SPRID) Score During the Double-Blind Period|The SPRID is defined as sum of PID and PAR Scores at 2 hours and 4 hours after the dosing on each evaluation day. The overall possible score ranges for SPRID is -4=worst to 14=best. The PID was calculated as PI at pre-dose on Day 1, 8, 15, 22, 28 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8, 15, 22, 28 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best and PAR was evaluated based on 5-stage scale with a score ranging from 0 to 4, wherein, 0=no relief and 4=complete relief.|Day 1, 8, 15, 22 and 28 of double-blind period|Efficacy analysis set included participants received at least one dose of the study drug. Here 'n' signifies number of participants evaluable at each time point for each arm respectively.||units on a scale||Standard Deviation|Mean
773869|NCT00736853|Secondary|Sum of Pain Relief Combined With Pain Intensity Difference (SPRID) Score During the Open-Label Period|The SPRID is defined as sum of PID and PAR Scores at 2 hours and 4 hours after the dosing on each evaluation day. The overall possible score ranges for SPRID is -4=worst to 14=best. The PID was calculated as PI at pre-dose on Day 1, 8 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best and PAR was evaluated based on 5-stage scale with a score ranging from 0=no relief to 4=complete relief.|Day 1, and Day 8 of open-label period|Efficacy analysis set included who received at least one dose of study drug. Here 'n' signifies number of participants evaluable for each time point.||units on a scale||Standard Deviation|Mean
773870|NCT00736853|Secondary|Total Pain Relief (TOTPAR) Score During the Double-Blind Period|The TOTPAR is defined as sum of PAR at 2 hours after dosing and the PAR at 4 hours after dosing on each evaluation day. Pain relief as evaluated on 5-stage scale with a score ranging from 0=no relief and 4=complete relief. Total possible score range for TOTPAR is 0=no relief to 8=complete relief.|Day 1, 8, 15, 22 and 28 of double-blind period|Efficacy analysis set included participants received at least one dose of the study drug. Here 'n' signifies number of participants evaluable at each time point for each arm respectively.||units on a scale||Standard Deviation|Mean
773871|NCT00736853|Secondary|Total Pain Relief (TOTPAR) Score During the Open-Label Period|The TOTPAR is defined as sum of PAR at 2 hours after dosing and the PAR at 4 hours after dosing on each evaluation day. Pain relief as evaluated on 5-stage scale with a score ranging from 0=no relief and 4=complete relief. Total possible score range for TOTPAR is 0=no relief to 8=complete relief.|Day 1 and Day 8 of open-label period|Efficacy analysis set included who received at least one dose of study drug. Here 'n' signifies number of participants evaluable for each time point.||units on a scale||Standard Deviation|Mean
773872|NCT00736853|Secondary|Sum of Pain Intensity Difference (SPID) Score During the Double-Blind Period|The SPID is defined as sum of the PID at 2 and 4 hours after dosing on each evaluation day. The overall possible score ranges for SPID is -4=worst to 6=best. The PID was calculated as PI at pre-dose on Day 1, 8, 15, 22, 28 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8, 15, 22, 28 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best.|Day 1, 8, 15, 22 and 28 of double-blind period|Efficacy analysis set included participants received at least one dose of the study drug. Here 'n' signifies number of participants evaluable at each time point for each arm respectively.||units on a scale||Standard Deviation|Mean
773873|NCT00736853|Secondary|Sum of Pain Intensity Difference (SPID) Score During the Open-Label Period|The SPID is defined as sum of the PID at 2 and 4 hours after dosing on each evaluation day. The overall possible score ranges for SPID is -4=worst to 6=best. The PID was calculated as PI at pre-dose on Day 1, 8 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best.|Day 1, and Day 8 of open-label period|Efficacy analysis set included participants received at least one dose of the study drug. Here 'n' signifies number of participants evaluable for this outcome measure at each time point.||units on a scale||Standard Deviation|Mean
773874|NCT00736853|Secondary|Pain Intensity Difference and Pain Relief Scores (PRID) During the Double-Blind Period|The PRID is defined as sum of PID and PAR Scores for each participant at each evaluation time point (at 2 and 4 hours after the dosing). The overall possible score range for PRID is -2=worst to 7=best. The PID was calculated as PI at pre-dose on Day 1, 8, 15, 22, 28 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8, 15, 22, 28 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best and PAR was evaluated based on a 5-stage scale score ranges from 0=no relief and 4=complete relief.|2 hours, 4 hours post-dose on Day 1, 8, 15, 22 and 28 of double-blind period|Efficacy analysis set included participants received at least one dose of the study drug. Here 'n' signifies number of participants evaluable at each time point for each arm respectively.||units on a scale||Standard Deviation|Mean
773875|NCT00736853|Secondary|Pain Intensity Difference and Pain Relief Scores (PRID) During the Open-Label Period|The PRID is defined as sum of PID and PAR Scores for each participant at each evaluation time point (at 2 and 4 hours after the dosing). The overall possible score ranges for PRID is -2=worst to 7=best. The PID was calculated as PI at pre-dose on Day 1, 8 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best and PAR was evaluated based on a 5-stage scale score ranges from 0=no relief and 4=complete relief.|2 hours, 4 hours post-dose on Day 1, and Day 8 of open-label period|Efficacy analysis set included who received at least one dose of study medication. Here 'n' signifies number of participants evaluable for each time point.||units on a scale||Standard Deviation|Mean
773876|NCT00736853|Secondary|Mean PAR Score During the Double-Blind Period|PAR was evaluated based on 5-stage scale with a score ranging from 0 to 4, wherein, 0=no relief and 4=complete relief.|2 hours, 4 hours post-dose on Day 1, 8, 15, 22 and 28 of double-blind period|Efficacy analysis set included participants received at least one dose of the study drug. Here 'n' signifies number of participants evaluable at each time point for each arm respectively.||units on a scale||Standard Deviation|Mean
773877|NCT00736853|Secondary|Mean Pain Relief (PAR) Score During the Open-Label Period|PAR was evaluated based on 5-stage scale with a score ranging from 0 to 4, wherein, 0=no relief and 4=complete relief.|2 hours, 4 hours post-dose on Day 1, and Day 8 of open-label period|Efficacy analysis set included participants who received at least one dose of study drug. Here 'n' signifies number of participants evaluable for this outcome measure at each time point.||units on a scale||Standard Deviation|Mean
773878|NCT00736853|Secondary|Mean PID During the Double-Blind Period|The PID was calculated as PI at pre-dose on Day 1, 8, 15, 22, 28 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8, 15, 22, 28 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best.|Pre-dose, and post-dose at 2 hours, 4 hours on Day 1, 8, 15, 22 and 28 of double-blind period|Efficacy analysis set included participants received at least one dose of the study drug. Here 'n' signifies number of participants evaluable at each time point for each arm respectively.||units on a scale||Standard Deviation|Mean
773879|NCT00736853|Secondary|Mean Pain Intensity Difference (PID) During the Open-Label Period|The PID was calculated as PI at pre-dose on Day 1, 8 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best.|Pre-dose, and post-dose at 2 hours, 4 hours on Day 1, and Day 8 of open-label period|Efficacy analysis set included participants who received at least one dose of study drug. Here 'n' signifies number of participants evaluable for this outcome measure at each time point.||units on a scale||Standard Deviation|Mean
773880|NCT00736853|Secondary|Mean PI Score During Double-Blind Period|The PI was evaluated on a 4-stage scale with a score ranging from 0 to 3, wherein 0=no pain and 3=severe pain.|Pre-dose and post-dose at 2 hours, 4 hours on Day 1, 8, 15, 22 and 28 of double-blind period|Efficacy analysis set included participants who received at least one dose of the study drug. Here 'n' signifies number of participants evaluable at each time point for each arm respectively.||units on a scale||Standard Deviation|Mean
773881|NCT00736853|Secondary|Mean Pain Intensity (PI) Score During Open-Label Period|PI was evaluated on a 4-stage scale with a score ranging from 0 to 3, wherein 0=no pain and 3=severe pain.|Pre-dose and post-dose at 2 hours, 4 hours on Day 1, and Day 8 of open-label period|Efficacy analysis set included participants who received at least one dose of study drug. Here 'n' signifies number of participants evaluable for this outcome measure at each time point.||units on a scale||Standard Deviation|Mean
773882|NCT00736853|Secondary|Change in the VAS24 Value From the Baseline at the Final Time Point of the Double-Blind Period|Pain over the last 24 hours was assessed by using VAS score ranges from 0 mm=no pain to 100 mm=worst possible pain. An increase in score from Baseline represented disease progression and decrease represented improvement.|Day 1 and Day 28 of double-blind period|Efficacy analysis set included participants who received at least one dose of the study drug.||mm||Standard Deviation|Mean
773883|NCT00736853|Secondary|Change in the Visual Analog Scale for the Last 24 Hours (VAS24) Value at the Start of the Double-Blind Period From the Baseline Value at the Start of the Open-Label Period|Pain over the last 24 hours was assessed by using VAS score ranges from 0 mm=no pain to 100 mm=worst possible pain. An increase in score from Baseline represented disease progression and decrease represented improvement.|Day 1 of open-label period and Day 1 of double-blind period|Efficacy analysis set included participants who received at least one dose of study drug.||mm||Standard Deviation|Mean
773884|NCT00736853|Primary|Number of Participants With Insufficient Pain Relief After the Start of Double-Blind Period|The pain relief was regarded as insufficient, if either of the following was met, a) the value of average pain intensity felt in daily living during the past 24 hours (Visual analog scale 24 [VAS24] ) on 2 consecutive days in double-blind period worsened greater than 15 millimeter (mm) compared with the average VAS24 during 3 days before the end of open-label period, b) when the participant asked for discontinuation of treatment with the study drug because of insufficient pain relief.|Day 28 of double-blind period|Efficacy analysis set included participants who received at least one dose of the study drug.||number of participants|||Number
773885|NCT00736879|Secondary|Number of Participants With Marked Laboratory Abnormalities in 24 Week Double Blind Treatment Period - Treated Participants|Safety laboratory measurements were obtained at Day 1, Weeks 1, 2, 4, 8, 12, 20, and 24 in the double blind Period. Baseline was defined as the last assessment prior to the start of the first dose of the double-blind study medication. Data included from baseline up to and including the last day of treatment plus 4 days. Data after rescue was also included. Abbreviations; Pretreatment (PreRX); grams per deciliter (g/dL); upper limit of normal (ULN); milliequivalent per liter (mEq/L); greater than (>) less than (<); Units per liter (U/L), alanine aminotransferase (ALT); aspartate aminotransferase (AST); alkaline phosphatase (ALP); blood urea nitrogen (BUN). Marked abnormality Low (High) defined: hemoglobin <6 (>18 females or >20 males) g/dL; hematocrit <20% ( >55% females or >60% males); BUN (>60 mg/dL) or Urea >21.4 mmol/L; creatinine (>=1.5*preRX, >=2.5 mg/dL); AST and ALT >3*ULN; bilirubin >1.5*ULN; ALP >1.5*ULN.|Baseline to Week 24/end of treatment plus 4 days|N=Number of participants who received at least 1 dose of study medication and had non-missing laboratory results.||participants|||Number
773886|NCT00736879|Secondary|Number of Participants With Normal or Abnormal Electrocardiogram Summary Tracing at Week 24 (LOCF) - Treated Participants|12-Lead electrocardiograms (ECGs) were performed at Day -14 and Week 24/End of treatment visit (last observation carried forward) on participants who were supine. ECGs were assessed by the investigator. Baseline (BL) was Day -14 for this parameter.|Week 24|N= Number of randomized participants, who took at least 1 dose of double-blind study medication, with non missing baseline (BL) and Week 24 (LOCF) values.||participants|||Number
773887|NCT00736879|Secondary|Mean Change From Baseline in Seated Heart Rate at Week 24 - Treated Participants|Heart rate values were obtained after the participant was seated for quietly for 5 minutes; the same arm (right or left) was used consistently through out the study. Measurements were taken at least 10 hours after the last ingestion of caffeine, alcohol, or nicotine. Heart rate was measured in beats per minute (bpm). Data after rescue were also included. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.|Baseline (Day 1), Week 24|N=number of participants who took at least 1 dose of double-blind study medication, with non missing baseline and Week 24 values.||bpm||Standard Error|Mean
773888|NCT00736879|Secondary|Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure at Week 24, Including Data After Rescue - Treated Participants|Blood pressure values were obtained on Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, and 24 in the double blind period, after the participant was seated for quietly for 5 minutes; the same arm (right or left) was used consistently through out the study. Measurements were taken at least 10 hours after the last ingestion of caffeine, alcohol, or nicotine. Blood pressure was measured in millimeters of mercury (mmHg). Data after rescue were also included. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.|Baseline (Day 1), Week 24|Participants who took at least 1 dose of double-blind study medication were analyzed. n= number of treated participants with non-missing baseline and Week 24 values.||mmHg||Standard Error|Mean
773889|NCT00736879|Secondary|Number of Participants With Adverse Events of Special Interest During the 12 Week Double Blind Period - All Treated Participants|Participants with AEs of hypoglycemia, cardiac/vascular disorders, renal impairment or failure, volume depletion (hypotension/dehydration/hypovolemia), fractures, urinary stones, and other reports suggestive of genital infection or urinary tract infection (UTI) were summarized using MedDRA version 12.1. Data after rescue included for all AEs of special interest except hypoglycemia; hypoglycemia AEs were prior to rescue. Major hypoglycemic episode: symptomatic requiring 3rd party assistance due to severe impairment in consciousness or behavior with a glucose value < 54 mg/dL and prompt recovery after glucose/glucagon; Minor: either symptomatic with glucose measurement < 63 mg/dL, regardless of need for 3rd party assistance, or asymptomatic with glucose < 63 mg/dL that does not qualify as major; Other: suggestive but not meeting criteria for major or minor.|Baseline to last dose plus 4 days in 12 Week Double Blind Period|Randomized participants who received at least one dose of study medication in the double-blind period. Data after rescue included for all AEs of special interest except hypoglycemia; hypoglycemia AEs summarized below were prior to rescue.||participants|||Number
773901|NCT00736944|Secondary|Correlate SPARC Expression (Intensity of Staining) by Immunohistochemistry (IHC) in Baseline Primary Tumor Tissue With Primary Tumor Site Partial Response Rate to Induction Chemotherapy|SPARC expression = intensity of SPARC staining in tumor|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|Patients who had available tumor tissue for SPARC testing and were partial responders.||participants|||Number
773902|NCT00736944|Secondary|Correlate SPARC Expression (Intensity of Staining) by Immunohistochemistry (IHC) in Baseline Primary Tumor Tissue With Primary Tumor Site Complete Response Rate to Induction Chemotherapy|SPARC expression = intensity of SPARC staining in tumor|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|Patients who had available tumor tissue for SPARC testing and were complete responders.||participants|||Number
773890|NCT00736879|Secondary|Number of Participants With Deaths, Serious AEs (SAEs), Adverse Events (AEs), Discontinuation Due to AEs, During the 12 Week Double Blind Period, Including Data After Rescue - All Treated Participants|Medical Dictionary for Regulatory Activities (MedDRA), version 12.1 AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug as per the investigator. Baseline to last dose plus 4 days for AEs, plus 30 days for SAEs. Data after rescue included.|Day 1 of Double Blind Period to end of Week 24 Plus 30 days|Participants who received at least 1 dose of double-blind study medication during the double-blind treatment period. Data after rescue were also included.||participants|||Number
773891|NCT00736879|Secondary|Adjusted Mean Change From Baseline in Waist Circumference at Week 24 (LOCF) - Randomization Participants|Adjusted mean waist circumference values from baseline to Week 24 (or the last post-baseline measurement prior to Week 24 if no Week 24 assessment was available, last observation carried forward, (LOCF) was determined. Data after rescue medication (metformin) was excluded from this analysis. Waist circumference was measured centimeters (cm) and obtained at lead-in, Day 1, and Week 24 of the double-blind period. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.|Baseline (Day 1), Week 24|Number of randomized participants, who took at least 1 dose of double-blind study medication, with non missing baseline and Week 24 (LOCF) values.||cm||Standard Error|Mean
773892|NCT00736879|Secondary|Adjusted Percentage of Participants Achieving a Therapeutic Glycemic Response at Week 24 (LOCF) - Randomized Participants|Therapeutic glycemic response was defined as HbA1c less than 7.0%. n=Number of participants with HBA1c less than (<) 7 % at Week 24, last observation carried forward (LOCF) while N=number of randomized participants with non-missing baseline and Week 24 (LOCF) values. Percent=n/N and was adjusted for Baseline HbA1c. Data after rescue medication (metformin) was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.|Baseline (Day 1), Week 24|N=number of randomized participants with non-missing baseline and Week 24 (LOCF) values.||Adjusted Percentage of participants|||Number
773893|NCT00736879|Secondary|Adjusted Mean Change From Baseline in Effect on 2-hour Post Liquid Meal Glucose at Week 24 (LOCF) - Randomized Participants|Liquid meal tolerance tests (MTTs) were scheduled to occur at Day 1 visit (MTT was to be completed 2 hours prior to first dose of treatment) and at Week 24 / End of treatment visit, or Rescue visit for participants meeting criteria for rescue due to lack of glycemic control. At Week 24, study treatment was given 1 hour before MTT was administered. Participant fasted for at least 10 hours (h) prior to both visits and abstained from tobacco, alcohol, and caffeine for 24 h prior to the MTT. The liquid meal supplement was administered over 10 minutes, starting immediately after Time 0 blood sample was drawn. Blood samples for post-liquid meal Glucose were obtained at 30, 60, 120, and 180 minutes after ingesting the liquid supplement. Glucose was measured in milligrams per deciliter (mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of double-blind study medication.|Baseline (Day 1), Week 24|Number of randomized participants, who took at least 1 dose of double-blind study medication, with non missing baseline and Week 24 (LOCF) values.||mg/dL||Standard Error|Mean
773894|NCT00736879|Secondary|Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 24 (LOCF) - Randomized Participants|Adjusted mean change in fasting plasma glucose (FPG) from baseline at Week 24 (LOCF) was determined. Data after rescue medication (metformin) was excluded from this analysis. FPG was measured as milligrams per deciliter (mg/dL) by a central laboratory at qualification, lead-in, Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, and 24 during double-blind period. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.|Baseline (Day 1), Week 24|Number analyzed = Number of randomized participants, who took at least 1 dose of double-blind study medication, with non missing baseline and Week 24 (LOCF) values.||mg/dL||Standard Error|Mean
773895|NCT00736879|Secondary|Adjusted Mean Change From Baseline in Total Body Weight at Week 24 (LOCF) - Randomized Participants|Adjusted mean change in total body weight from baseline at Week 24, or the last post-baseline measurement prior to Week 24 if no Week 24 assessment was available LOCF was determined. Data after rescue medication (metformin) was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight was measured in kilograms (kg) at qualification, lead-in, Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, and 24 during double-blind period.|Baseline (Day 1), Week 24|N= Number of randomized participants, who took at least 1 dose of double-blind study medication, with non missing baseline and Week 24 (LOCF) values.||kg||Standard Error|Mean
773896|NCT00736879|Primary|Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 Last Observation Carried Forward (LOCF) - All Randomized Participants|Adjusted mean change in HbA1c from baseline at Week 24, or the last post-baseline measurement prior to Week 24 if no Week 24 assessment was available was determined(LOCF). HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication (metformin) was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c values were obtained at enrollment, lead-in, and at Day 1, Weeks 4, 8, 12, 16, 20, and 24 in the double-blind period.|Baseline (Day 1), Week 24|N= Number of randomized participants, who took at least 1 dose of double-blind study medication, with non missing baseline and Week 24 (LOCF) values.||Percent Hemoglobin||Standard Error|Mean
773897|NCT00736944|Secondary|Progression-free Survival|Time from initiation of induction chemotherapy to death due to disease progression, to disease progression, or to last follow-up alive.|10 years from completion of treatment||08/2020||||
773903|NCT00736944|Secondary|Correlate SPARC Expression by Immunohistochemistry (IHC) in Baseline Primary Tumor Tissue With Primary Tumor Site Partial Response Rate to Induction Chemotherapy|SPARC expression = Proportion of tumor cells SPARC-positive in 10 high-power fields|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|Patients who had available tumor tissue for SPARC testing and were partial responders.||participants|||Number
773904|NCT00736944|Secondary|Correlate SPARC Expression by Immunohistochemistry (IHC) in Baseline Primary Tumor Tissue With Primary Tumor Site Complete Response Rate to Induction Chemotherapy|SPARC expression = Proportion of tumor cells SPARC-positive in 10 high-power fields|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|Patients who had available tumor tissue for SPARC testing and were complete responders.||participants|||Number
773905|NCT00736944|Secondary|Correlate Overall Tumor Response Rates Based on Visual Categorical Criteria of Assessment With That Based on CT Scan and FDG-PET/CT|In the future, primary tumor site, nodal, and overall tumor response by visual categorical response (CR-x or PR-x = yes or no) will be compared with response based on CT scan (CR-x or PR-x = yes or no) using a test for difference in paired, binary values (e.g., McNemar's test). Median standardized uptake value of FDG measured by PET/CT will be compared among those with or without response (CR-x or PR-x) using nonparametric Wilcoxon-Mann-Whitney tests. At this point, we are releasing results based on comparing actual responses from visual categorical response, CT scan, and FDG-PET/CT scan after 2 cycles of induction.|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|1 patient was not evaluable for CT scan because the primary site could not be clearly measured and was noted as non-target lesion. 1 patient was not evaluable for PET scan because the patient's insurance company denied coverage.||percentage of participants|||Number
773906|NCT00736944|Secondary|Correlate Nodal Response Rates Based on Visual Categorical Criteria of Assessment With That Based on CT Scan and FDG-PET/CT|In the future, primary tumor site, nodal, and overall tumor response by visual categorical response (CR-x or PR-x = yes or no) will be compared with response based on CT scan (CR-x or PR-x = yes or no) using a test for difference in paired, binary values (e.g., McNemar's test). Median standardized uptake value of FDG measured by PET/CT will be compared among those with or without response (CR-x or PR-x) using nonparametric Wilcoxon-Mann-Whitney tests. At this point, we are releasing results based on comparing actual responses from visual categorical response, CT scan, and FDG-PET/CT scan after 2 cycles of induction.|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|12 patients were not evaluable for VSR because they did not have nodal disease. 6 patients were not evaluable for CT scan because 5 patients did not have nodal disease and 1 patient didn't have measurable nodal disease. 5 patients were not evaluable for PET because 5 patients did not have nodal disease.||percentage of participants|||Number
773907|NCT00736944|Secondary|Correlate Primary Tumor Site Response Rates Based on Visual Categorical Criteria of Assessment With That Based on CT Scan and FDG-PET/CT|"In the future, primary tumor site, nodal, and OTR by VCR (CR-x or PR-x = Y or N) will be compared with response based on CT scan (CR-x or PR-x = Y or N) using a test for difference in paired, binary values. Median standardized uptake value of FDG measured by PET/CT will be compared among those with or without response (CR-x or PR-x) using nonparametric Wilcoxon-Mann-Whitney tests.
We are releasing results based on comparing actual responses from visual categorical response, CT scan, and FDG-PET/CT scan after 2 cycles."|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|2 patients were not evaluable for the CT Scan of this outcome because they did not have primary disease that could be measured per RECIST. 2 patients were not evaluable for PET scan of this outcome because one patient's insurance company denied coverage and the other patient did not have primary site disease.||percentage of participants|||Number
773908|NCT00736944|Secondary|Radiographic Overall Complete and Partial Response Rates as Assessed by Conventional CT Scan Using RECIST Criteria|"Complete response rate per RECIST criteria is defined as disappearance of all target lesions.
Partial response rate per RECIST criteria is defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter."|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|One patient was not evaluable for this outcome. This patient had primary site disease that could not be clearly measured per CT and was listed as a non-target lesion.||participants|||Number
773909|NCT00736944|Secondary|Radiographic Complete and Partial Response Rates of Involved Lymph Nodes as Assessed by Conventional CT Scan Using RECIST Criteria|"Complete response rate per RECIST criteria is defined as disappearance of all target lesions.
Partial response rate per RECIST criteria is defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter."|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|Six patients were not evaluable for this outcome. Five of these patients did not have any involved lymph nodes available to evaluate. The sixth patient did not have involved lymph nodes that were clearly measurable by CT and RECIST.||participants|||Number
773910|NCT00736944|Secondary|Radiographic Complete and Partial Response Rates of Primary Tumor as Assessed by Conventional CT Scan Using RECIST Criteria|"Complete response rate per RECIST criteria is defined as disappearance of all target lesions.
Partial response rate per RECIST criteria is defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter."|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|Two patients were not evaluable for this outcome. The first patient didn't have primary site disease that could be measured by RECIST. The second patient had primary site disease but it could not be clearly measured by CT. This disease was noted as a non-target lesion as present at baseline.||participants|||Number
773911|NCT00736944|Other Pre-specified|Overall Complete and Partial Response Rates by FDG Uptake on PET Scan|"Complete response rate defined as complete resolution of the metabolically active primary tumor.
Partial response rate defined as 20% or greater decrease in maximum SUV [SUV g/ml) = ROI activity (mCi/ml) / (injected dose (mCi/body weight(g))] from baseline. No unequivocal metabolic progression of non-target disease, and no unequivocal new lesions."|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|One patient was not evaluable for this outcome. This patient's insurance company denied coverage for the post-cycle 2 timepoint and because of this was not included in this overall response rate for PET scan.||participants|||Number
775853|NCT00754065|Secondary|Mean Length of Spotting-only Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
773912|NCT00736944|Secondary|Complete and Partial Response Rates of Involved Lymph Nodes by FDG Uptake on PET Scan|"Complete response rate defined as complete resolution of the metabolically active primary tumor.
Partial response rate defined as 20% or greater decrease in maximum SUV [SUV g/ml) = ROI activity (mCi/ml) / (injected dose (mCi/body weight(g))] from baseline. No unequivocal metabolic progression of non-target disease, and no unequivocal new lesions."|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|Five patients were not evaluable for this outcome because these patients did not have any involved lymph nodes that could be measured.||participants|||Number
773913|NCT00736944|Secondary|Complete and Partial Response Rates of Primary Tumor by FDG Uptake on PET Scan|"Complete response rate defined as complete resolution of the metabolically active primary tumor.
Partial response rate defined as 20% or greater decrease in maximum SUV [SUV g/ml) = ROI activity (mCi/ml) / (injected dose (mCi/body weight(g))] from baseline. No unequivocal metabolic progression of non-target disease, and no unequivocal new lesions."|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|Two patients were not evaluable for this outcome. One patient's insurance company denied coverage for the PET scan so the PET scan was not performed. The other patient only had neck nodes that were clearly measurable on the PET scan, the primary site could not be measured on the PET scan.||participants|||Number
773914|NCT00736944|Secondary|Clinical Overall Complete and Partial Response Rates|"Clinical exam included laryngoscopy in office or operating room.
Clinical exam consisted of physical exam of neck in office.
Complete response rate includes complete response (CR) which is defined as 100% decrease in tumor size and it also includes near complete response (near CR) defined as 95-99% decrease in tumor size.
Partial response rate defined as 50% to 94% decrease in tumor size."|post-2 cycles of induction therapy (approximately 42 days)|||participants|||Number
773915|NCT00736944|Secondary|Clinical Complete and Partial Response Rates to the Involved Regional Nodes|"Clinical exam consisted of physical exam of neck in office.
Complete response rate includes complete response (CR) which is defined as 100% decrease in tumor size and near complete response (near CR) defined as 95-99% decrease in tumor size.
Partial response rate defined as 50% to 94% decrease in tumor size."|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|Twelve patients were not evaluable because of initial absence of nodal disease on clinical exam.||participants|||Number
773916|NCT00736944|Secondary|Clinical Partial Response Rate at the Primary Tumor|"Clinical exam included laryngoscopy in office or operating room.
Partial response rate (PR) defined as 50% to 94% decrease in tumor size."|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|Participants who completed 2 cycles of induction therapy||participants|||Number
773917|NCT00736944|Primary|Clinical Complete Response Rate at the Primary Tumor|"Clinical exam included laryngoscopy in office or operating room.
Complete response rate includes complete response (CR) which is defined as 100% decrease in tumor size and it also includes near complete response (near CR) defined as 95-99% decrease in tumor size."|post-2 cycles of induction (approximately 42 days from start of treatment)|All patients who completed 2 cycles of induction therapy.||participants|||Number
773918|NCT00736957|Secondary|Change From Baseline in Short Form-36 (SF-36) Score|SF-36 is a metric for general health and Quality of Life (QOL), consists of 8 sub-scale indices related to health and QOL (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, mental health). Each of the sub-scale scores ranged from 0 to 100, where higher values indicate a better health status or a better mental status.|Baseline, Week 4 and 52|Full analysis set included all participants who met the eligibility criteria, received study medication and had at least one post-treatment efiicacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure and n = the number of participants with measurements for that time point.||units on a scale||Standard Deviation|Mean
773919|NCT00736957|Secondary|Pain Relief Combined With Pain Intensity Difference (PRID) at Week 4|PRID was sum of the PID and PAR for each participant at each evaluation time point (2 hours after dosing, 4 hours after dosing). Pain Intensity was evaluated on a 4-stage scale ranges from 3=severe pain to 0=no pain and PID ranges from -3 (the worst) to +3 (the most improved). PAR ranges from 0 (no improved) to +4 (the most improved). PRID ranges from -3 (the worst) to +7 (the most improved).|Week 4|Full analysis set included all participants who met the eligibility criteria, received study medication and had at least one post-treatment efiicacy assessment. Participants showing a Pain Intensity (PI) value of 0 prior to dosing at each evaluation time point were not included in the analysis.||units on scale||Standard Deviation|Mean
773920|NCT00736957|Secondary|Pain Relief (PAR) Score at Week 4|Pain relief was evaluated based on a 5-stage scale from 4 (complete relief) to 0 (no relief). An increase in score represented improvement and decrease represented disease progression|Week 4|Full analysis set included all participants who met the eligibility criteria, received study medication and had at least one post-treatment efiicacy assessment. Participants showing a Pain Intensity (PI) value of 0 prior to dosing at each evaluation time point were not included in the analysis.||units on a scale||Standard Deviation|Mean
773921|NCT00736957|Secondary|Pain Intensity Difference (PID) at Week 4|PID is defined as the amount of change in the pain intensity at each evaluation time point (at 2 and 4 hours after the study drug dosing) from the baseline for each participant. Pain Intensity was evaluated on a 4-stage scale ranging from 3=severe pain to 0=no pain. PID ranges from -3 (the worst) to +3 (the most improved).|Week 4|Full analysis set included all participants who met the eligibility criteria, received study medication and had at least one post-treatment efiicacy assessment. Participants showing a Pain Intensity (PI) value of 0 prior to dosing at each evaluation time point were not included in the analysis.||units on a scale||Standard Deviation|Mean
773922|NCT00736957|Secondary|Number of Participants With Improvement From Baseline in VAS24 Score|Pain over the last 24 hours was assessed by using VAS score ranges from 0 mm=no pain to 100 mm=worst possible pain. An increase in score from baseline represented disease progression and decrease represented improvement.|Week 4 and 52|Full analysis set included all participants who met the eligibility criteria, received study medication and had at least one post-treatment efiicacy assessment. Last Observation Carried Forward (LOCF) method was used.||participants|||Number
773923|NCT00736957|Primary|Change From Baseline in VAS24 Score at Week 52|Pain over the last 24 hours was assessed by using VAS score ranges from 0 mm=no pain to 100 mm=worst possible pain. An increase in score from baseline represented disease progression and decrease represented improvement.|Baseline and Week 52|Full analysis set included all participants who met the eligibility criteria, received study medication and had at least one post-treatment efiicacy assessment.||millimeter||Standard Deviation|Mean
773924|NCT00736957|Primary|Change From Baseline in Visual Analogue Scale (VAS24) Score at Week 4|Pain over the last 24 hours was assessed by using VAS score ranges from 0 millimeter (mm)=no pain to 100 mm=worst possible pain. An increase in score from baseline represented disease progression and decrease represented improvement.|Baseline and Week 4|Full analysis set included all participants who met the eligibility criteria, received study medication and had at least one post-treatment efiicacy assessment.||millimeter||Standard Deviation|Mean
773925|NCT00736996|Secondary|Change in Peak Oxygen Uptake (VO2 Peak)|Peak oxygen consumption (VO2 peak, ml/kg/min) was determined by open circuit spirometry during a standard treadmill stress test (modified Balke protocol).|Baseline to 6 months|||ml/kg/min||95% Confidence Interval|Number
773926|NCT00736996|Secondary|Change in Insulin Resistance|Change in whole body glucose disposal rate (mg/kg/min) calculated during a single-stage (40 mU/m2/min), 3-hour hyperinsulinemic, euglycemic clamp|Baseline to 6 months|||mg/kg/min||95% Confidence Interval|Number
773927|NCT00736996|Primary|Change in Cognitive Performance|Participants were administered a neuropsychological testing battery consisting of assessments in four cognitive domains: memory (Visual Reproduction II, Logical Memory II, Rey Auditory Verbal Learning Test), language (Boston Naming Test , Category Fluency), visuospatial (Block Design, Picture Completion), and executive function (Trail Making Test B, Digit Symbol Test). Raw test scores for these primary cognitive domain measures were transformed into age-adjusted scaled scores with a mean of 10 and a standard deviation (SD) of 3, with higher numbers indicating better cognitive performance, using the Mayo’s Older American Normative Studies data. Cognitive domain scores were calculated as the arithmetic mean of the normatively derived scaled scores for all of the tests in that domain.|Baseline to 6 months|||units on a scale||95% Confidence Interval|Number
773928|NCT00737048|Secondary|Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain|"Percentage of participants were assessed with treatment response based on evaluation criteria for efficacy of analgesics in post-tooth-extraction pain for the efficacy of analgesics used to treat pain following tooth extraction. Participants were assessed as very effective, effective, somewhat effective and ineffective for the following categories: Pain suppression (PS), speed of pain relief (SPR), duration of pain relief (DPR), general effectiveness (GE). Participants judged the treatment as extremely useful, useful, not useful & could not be assessed for overall evaluation (OE)."|Baseline up to 8 hours post-administration of study treatment|FAS population included all the participants who received the study treatment and had efficacy assessment data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure & 'n' signifies those participants who were evaluable for this measure at given time points.||Percentage of participants|||Number
773929|NCT00737048|Secondary|Number of Participants Treated With a Relief Analgesic|Participants who were treated with a relief analgesic were assessed. Analgesics are the compounds capable of relieving pain without the loss of consciousness.|Baseline up to 8 hours post-administration of study treatment|FAS population included all the participants who received the study treatment and had efficacy assessment data.||Participants|||Number
773930|NCT00737048|Secondary|Percentage of Participants With Categorical Score for Patient Impressions|Percentage of participants with patient impressions were assessed on categories, that are: worked well; worked; worked a little; and didn’t work.|Baseline up to 8 hours post-administration of study treatment|FAS population included all the participants who received the study treatment and had efficacy assessment data.||Percentage of participants|||Number
773931|NCT00737048|Secondary|Time to Reach the Onset of Drug Efficacy and Time to Recurrence of Pain After the Onset of Drug Efficacy|Time to reach the onset of drug efficacy (TOE) means time took by participants for the onset of relief from pain after tooth-extraction and time to recurrence of pain (TOR) after the onset of drug efficacy (that is, duration of drug efficacy) were assessed after study drug treatment.|Baseline up to 8 hours post-administration of study treatment|FAS population included all the participants who received the study treatment and had efficacy assessment data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure & 'n' signifies those participants who were evaluable for this measure at given time points.||Minutes||Standard Deviation|Mean
773932|NCT00737048|Secondary|Mean Change Over Time for Pain Relief Combined With Pain Intensity Difference (PRID) at 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 Hours Post-administration of Study Treatment|Pain Relief combined with pain Intensity Difference (PRID) represented pain relief scores combined with Pain Intensity difference (PID) scores. PRID score ranges from -3 (the worst) through +7 (the most improved). Higher score indicates treatment response. Mean change from Baseline (that is, 0 hours after tooth extraction) at specified end time points were evaluated.|0.5, 1, 2, 3, 4, 5, 6, 7 and 8 hours post-administration of study treatment|FAS population included all the participants who received the study treatment and had efficacy assessment data.||Units on a scale||Standard Deviation|Mean
773933|NCT00737048|Secondary|Mean Change Over Time for Pain Relief (PAR) at 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 Hours Post-administration of Study Treatment|Pain Relief (PAR) was assessed using numerical rating scale score ranging from 0 to 32, wherein 0 indicates no treatment response and 32 indicates the most improved. Higher score indicates treatment response. Mean change from Baseline (that is, 0 hours after tooth extraction) at specified end time points were evaluated.|0.5, 1, 2, 3, 4, 5, 6, 7 and 8 hours post-administration of study treatment|FAS population included all the participants who received the study treatment and had efficacy assessment data.||Units on a scale||Standard Deviation|Mean
773934|NCT00737048|Secondary|Mean Change Over Time for Pain Intensity Difference (PID) at 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 Hours Post-Administration of Study Treatment|The PID is defined as difference between current pain intensity (PI) and Baseline PI, PI was assessed using numerical rating scale score ranging from 0 to 32, wherein 0 indicates no treatment response and 32 indicates the most improved. Higher score indicates treatment response. Mean change from Baseline (that is, 0 hours after tooth extraction) at specified end time points were evaluated.|0.5, 1, 2, 3, 4, 5, 6, 7 and 8 hours post-administration of study treatment|FAS population included all the participants who received the study treatment and had efficacy assessment data.||Units on a scale||Standard Deviation|Mean
773948|NCT00737061|Secondary|Device Placement Rate|Defined as successful bilateral tubal access followed by successful bilateral RF treatment and matrix placement.|Including Second Treatment Attempt|Device placement rate reported on a per participant basis for 645 intent to treat participants. Successful bilateral placement of the matrices was achieved in 611/645 participants after 7 participants underwent a successful second attempt.||percentage of participants|||Number
773935|NCT00737048|Secondary|Change From Baseline in Visual Analog Scale (VAS) Score at 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 Hours Post-administration of Study Treatment|Pain was assessed by using Visual Analogue Scale (VAS) score ranges from 0 millimeter (mm)=no pain to 100 mm=worst possible pain. An increase in score from Baseline represented disease progression and decrease represented treatment response.|0.5, 1, 2, 3, 4, 5, 6, 7 and 8 hours post-administration of study treatment|FAS population included all the participants who received the study treatment and had efficacy assessment data.||Units on a scale||Standard Deviation|Mean
773936|NCT00737048|Secondary|Sum of Pain Relief Combined With Pain Intensity Difference (SPRID)|The SPRID is the sum of pain relief scores combined with pain intensity difference, score ranging from from (-) 24 (the worst) through 56 (the most improved). Higher score indicates treatment response. Pain Intensity (PI) and Pain relief (PAR) were assessed using numerical rating scale score ranging from 0 to 32, wherein 0 indicates no treatment response and 32 indicates the most improved. Scores were measured at Baseline (that is, 0 hours after tooth extraction) and at 8 hours post-administration of study treatments. Pain intensity difference (PID) was calculated (that is, for 0-8 hours, time point [8 hour] score minus baseline [0 hour] score).|Baseline up to 8 hours post-administration of study treatment|FAS population included all the participants who received the study treatment and had efficacy assessment data.||Units on a scale||Standard Deviation|Mean
773937|NCT00737048|Secondary|Sum of Pain Intensity Difference (SPID)|Pain Intensity (PI) was assessed using numerical rating scale score ranging from 0 to 32, wherein 0 indicates no treatment response and 32 indicates the most improved. Scores were measured at Baseline (that is, 0 hours after tooth extraction) and 8 hours post-administration of study treatments.Pain intensity difference (PID) was calculated (that is, for 0-8 hours, time point [8 hour] score minus baseline [0 hour] score).|Baseline up to 8 hours post-administration of study treatment|FAS population included all the participants who received the study treatment and had efficacy assessment data.||Units on a scale||Standard Deviation|Mean
773938|NCT00737048|Secondary|Total Pain Relief Based on Numerical Rating Scale (NRS) Score Every 4 Hours up to 8 Hours|Total pain relief was evaluated using numerical rating scale score ranging from 0 to 32, wherein 0 indicates no treatment response and 32 indicates the most improved. Higher score indicates treatment response.|Baseline up to 8 hours post-administration of study treatment|FAS population included all the participants who received the study treatment and had efficacy assessment data.||Units on a scale||Standard Deviation|Mean
773939|NCT00737048|Primary|Total Pain Relief Based on Numerical Rating Scale (NRS) Score|Total pain relief was evaluated using numerical rating scale score ranging from 0 to 32, wherein 0 indicates no treatment response and 32 indicates the most improved. Higher score indicates treatment response.|8 hours|Final analysis set (FAS) population included all the participants who received the study treatment and had efficacy assessment data.||Units on a scale||Standard Deviation|Mean
773940|NCT00737061|Secondary|3 Year Pregnancy Rate|Pregnancy rate is defined as the cumulative percentage of pregnancies occuring within the time frame. The pregnancy rate was evaluated for all participants who underwent successful bilateral treatment and who had demonstrated tubal occlusion by hysterosalpingogram (HSG) at the end of the Waiting Period who have been followed for up to 3 years.|3 years|Population includes all participants able to rely on Adiana (n=570). This analysis is cumulative and based on survival analysis methodology. Thus, participants only followed for 2 years, for example, would still be included in this cumulative analysis. In total, 481 participants were available with 3 years of follow-up at the time of analysis.||percentage of participants|||Number
773941|NCT00737061|Secondary|Patient Comfort With Device Wearing|Determined by verbal questions during periodic follow-up contacts. Endpoint represents minimum percentage of subjects reporting good, very good or excellent comfort.|Wearing Period (3-Months, 6-Months, 9-Months, 12-Months)|Per protocol population; no imputations for missing data. Minimum comfort reported at 12-Months as 530/532 participants.||percentage of participants|||Number
773942|NCT00737061|Secondary|Patient Comfort With Device Wearing|Determined by verbal questions during periodic follow-up contacts. Endpoint represents minimum percentage of subjects reporting good, very good or excellent comfort.|Waiting Period (1-Month, 2-Months, 3-Months)|Intent to treat population; no imputations for missing data. Minimum comfort reported at 1-Month as 604/608 participants.||percentage of participants|||Number
773943|NCT00737061|Secondary|Patient Comfort With Placement Procedure|Determined by verbal questions up to 48 hours post placement. Endpoint reported represents minimum percentage of participants reporting any discomfort or pain experienced in first 48 hours following procedure as the same as they expected, less than they expected or no pain.|48 hours|Intent to treat population; no imputations for missing data. Minimum comfort reported as 578/632 participants.||percentage of participants|||Number
773944|NCT00737061|Secondary|Patient Comfort With Placement Procedure|Determined by verbal questions two hours following procedure or at discharge from facility, whichever came first. Endpoint reported represents minimum percentage of participants reporting any discomfort or pain experienced during the procedure as the same as or less than they expected.|Post-Procedure|Intent to treat population; no imputations for missing data. Minimum comfort reported as 504/629 participants.||percentage of participants|||Number
773945|NCT00737061|Secondary|Patient Satisfaction With Device Wearing|Determined by verbal questions during periodic follow-up contacts. Endpoint reported represents minimum percentage of subjects reporting somewhat satisfied, satisfied or very satisfied.|Wearing Period (3-Months, 6-Months, 9-Months, 12-Months)|Per protocol population; no imputations for missing data. Minimum satisfaction reported at 12-Months as 528/531 participants.||percentage of participants|||Number
773946|NCT00737061|Secondary|Patient Satisfaction With Device Wearing|Determined by verbal questions during periodic follow-up contacts. Endpoint reported represents minimum percentage of subjects reporting somewhat satisfied, satisfied or very satisfied.|Waiting Period (1-Month, 2-Months, 3-Months)|Intent to treat population; no imputations for missing data. Minimum satisfaction reported at 2-Months as 587/613 participants.||percentage of participants|||Number
773947|NCT00737061|Secondary|Patient Satisfaction With Placement Procedure|Determined by verbal questions up to 48 hours post placement. Endpoint reported represents minimum percentage of participants reporting somewhat satisfied, satisfied or very satisfied.|48 hours|Intent to treat population; no imputations for missing data. Minimum satisfaction reported as 605/625 participants.||percentage of participants|||Number
787068|NCT00839930|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
773950|NCT00737061|Primary|1 Year Pregnancy Rate|Pregnancy rate is defined as the cumulative percentage of pregnancies occuring within the time frame. The primary endpoint for this study is the pregnancy prevention rate after one year of reliance on the Adiana System for pregnancy prevention. The pregnancy rate was evaluated for all participants who underwent successful bilateral treatment and who had demonstrated tubal occlusion by hysterosalpingogram (HSG) at the end of the Waiting Period.|1 year|645 participants had treatment attempted; Intent to Treat population. Of these 645, 570 were able to rely on the device and are used to evaluate the pregnancy prevention rate for the 1-year endpoint. During the 1-year follow-up period, there were 6 pregnancies, of which 3 were attributable to physician error, i.e., misinterpretation of HSG results.||percentage of participants|||Number
773951|NCT00737100|Secondary|Clinical Relevant Abnormalities for Vital Signs and Laboratory Evaluation|Clinical Relevant Abnormalities for Vital Signs and Laboratory evaluation. Any new or clinically relevant worsening of baseline conditions was reported as Adverse Event.|From first drug administration until 30 days after last drug administration (up to 121 days)|Treated set||participants|||Number
773952|NCT00737100|Secondary|Time From Dosing to the Maximum Concentration (Tmax,ss)|Tmax,ss represents the time from dosing to the maximum concentration of tiotropium in plasma|pre-dose, and 5 minutes (min), 20 min, 1 hour (h), and 2 h post-dose|Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement - patients >= 12 years||h||Full Range|Median
773953|NCT00737100|Secondary|Maximum Measured Concentration at Steady State (Cmax,ss)|Cmax,ss represents the maximum measured concentration of tiotropium in plasma at steady state.|pre-dose, and 5 minutes (min), 20 min, 1 hour (h), and 2 h post-dose|Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement - patients >= 12 years||pg/mL||Geometric Coefficient of Variation|Geometric Mean
773954|NCT00737100|Secondary|Amount of Tiotropium Eliminated in Urine From 0 to 4 Hours at Steady State (Ae0-4,ss)|Ae0-4,ss represents the amount of tiotropium that is eliminated in urine from time 0 to 4 hours at steady state|pre-dose, and 5 minutes (min), 20 min, 1 hour (h), and 2 h post-dose|Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement - patients >= 12 years||ng||Geometric Coefficient of Variation|Geometric Mean
773955|NCT00737100|Secondary|Change From Baseline in CFQ Scores - Parent Questionnaire|The Cystic Fibrosis questionnaire (CFQ) is a disease-specific instrument that measures health-related quality of life (HRQOL) for adolescents with CF - parent questionnaire. This validation questionnaire consists of 50 items on generic and disease-specific scales. The scores range from 0 to 100, with higher scores indicating better health.|12 weeks|Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement||units on a scale||Standard Deviation|Mean
773956|NCT00737100|Secondary|Change From Baseline in CFQ Scores - Adolescents Group|The Cystic Fibrosis questionnaire (CFQ) is a disease-specific instrument that measures health-related quality of life (HRQOL) for adolescents (age 6-13) with CF. This validation questionnaire consists of 50 items on generic and disease-specific scales. The scores range from 0 to 100, with higher scores indicating better health.|12 weeks|Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement||units on a scale||Standard Deviation|Mean
773957|NCT00737100|Secondary|Change From Baseline in CFQ Scores - Adult Group|The Cystic Fibrosis questionnaire (CFQ) is a disease-specific instrument that measures health-related quality of life (HRQOL) for adults with CF. This validation questionnaire consists of 50 items on generic and disease-specific scales. The scores range from 0 to 100, with higher scores indicating better health.|12 weeks|Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement||units on a scale||Standard Deviation|Mean
773958|NCT00737100|Secondary|Respiratory and Systemic Symptoms Questionnaire (RSSQ)|Outcome measure description: The RSSQ questionnaire is used to determine the presence or absence of an exacerbation during the recall period.|12 weeks|Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement||Participants|||Number
773959|NCT00737100|Secondary|Change From Baseline in Residual Volume/Total Lung Capacity (RV/TLC) at the End of Week 12|Change from baseline in static lung hyperinflation as measured by RV/TLC. Calculated as percent predicted at week 12 minus percent predicted at baseline.|Baseline, Week 12|Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement||Percentage change||Standard Error|Least Squares Mean
773960|NCT00737100|Secondary|Pre-bronchodilator FEF25-75 Percent Predicted at the End of Week 12|Forced Expiratory Flow at 25-75% of vital capacity (FEF25-75). Calculated as percent predicted at week 12 minus percent predicted at baseline.|Baseline, Week 12|Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement||Percentage change||Standard Error|Least Squares Mean
773961|NCT00737100|Secondary|Percent Predicted FVC Trough Response at the End of Week 12|Change from baseline in percent predicted trough Forced Vital Capacity (FVC). Calculated as percent predicted at week 12 minus percent predicted at baseline.|Baseline, Week 12|Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement||Percentage change||Standard Error|Least Squares Mean
773962|NCT00737100|Secondary|Percent Predicted FVC AUC0-4 Response at the End of Week 12|Change from baseline in percent predicted Forced Vital Capacity (FVC) Area Under the Curve from 0 to 4 hours (AUC0-4). Calculated as percent predicted at week 12 minus percent predicted at baseline.|Baseline, Week 12|Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement||Percentage change||Standard Error|Least Squares Mean
773963|NCT00737100|Primary|Percent Predicted FEV1 Trough Response at the End of Week 12|Outcome measure description: Change from baseline in percent predicted trough Forced Expiratory Volume in one second. Calculated as percent predicted at week 12 minus percent predicted at baseline.|Baseline, Week 12|Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement||Percentage change||Standard Error|Least Squares Mean
773964|NCT00737100|Primary|Percent Predicted FEV1 AUC0-4 Response at the End of Week 12|Outcome measure description: Change from baseline in percent predicted Forced Expiratory Volume in one second (FEV1) Area Under the Curve from 0 to 4 hours (AUC0-4). Calculated as percent predicted at week 12 minus percent predicted at baseline.|Baseline, Week 12|Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement||Percentage change||Standard Error|Least Squares Mean
773966|NCT00737178|Secondary|Expulsion and Removal Rates|"Expulsion rates were defined as the number of IUDs expelled from the uterus among participants who had the IUD inserted during the study.
Removal rates were defined as the number of IUDs that were electively removed by participant request among participants who had the IUD inserted during the study."|Within six months of medication abortion|Per protocol: insertion and removal rates were calculated only for participants undergoing IUD insertion||participants|||Number
773967|NCT00737178|Secondary|Insertion Rates|Insertion rates are the proportion of women in each allocation group (immediate, delayed) who ultimately had the IUD inserted within the 6 month study period.|By six months after medication abortion|||participants|||Number
773968|NCT00737204|Secondary|HIV Viral Load|"HIV RNA viral load assay is a laboratory measure indicating viral activity. Because of the large range of possible values (50 - 100,000 copies), this measure is transformed to log10 values. We entered the log10 value of 1.69 when the laboratory result stated under 50 copies, which was the assay's lowest limit of detectability during the study."|Measured at baseline and Week 4|Results were included for patients on whom baseline and week 4 labs were drawn.||Log10 copies/mL||Standard Deviation|Mean
773969|NCT00737204|Secondary|CD4 Cell Count|Cd4 cell count is a laboratory marker providing an indication of immune system functioning. Blood samples were drawn for this measure at baseline and week 4. The reference range for CD4 cell count is 490-1740, and a clinically significant change is defined as a change of >=100 cells. A higher number is associated with better immune functioning.|Measured at baseline and Week 4|Results were included for patients on whom baseline and week 4 labs were drawn.||Cells/mcL||Standard Deviation|Mean
773970|NCT00737204|Primary|Role Function Scale|The Role Function Scale includes 10 items drawn from the Short Form 36-item Survey (SF-36) and other SF versions. It is intended to assess the extent to which fatigue has a behavioral impact on daily activities. Scores of frequency in the past week, on a 5-point scale, are summed with higher scores signifying greater role impairment. Scores range from 10-50.|Measured at Baseline and Week 4|The week 4 outcome analyses are based on an intention to treat sample, which includes the 6 dropouts, using the last data point brought forward.||units on a scale||Standard Deviation|Mean
773971|NCT00737204|Primary|Fatigue Severity Scale(FSS) Outcome|The FSS is a 9-item self-report scale that measures the impact of fatigue on everyday functioning. Each item is rated on a scale of 1 to 7. Total scores range from 9-63, with a higher score indicating greater impairment due to fatigue.|Measured at baseline and Weeks 4|Of the 70 patients randomized, 64 completed the 4-week trial. Data presented are for the 70, using the last data point carried forward (intention to treat).||units on a scale||Standard Deviation|Mean
773972|NCT00737243|Secondary|Number of Participants With a Tissue of Origin Successfully Predicted by the Assay|To evaluate the utility of the assay in identifying the tissue of origin in patients with carcinoma of unknown primary site (CUP), an archived tumor specimen was assayed upon study entry. If a tissue of origin was predicted by the assay, participants received standard site-specific therapy for that tumor type. When tissue of origin was not predicted by the assay, patients received standard empiric chemotherapy for CUP and were not followed further. If the assay was not completed due to inadequate amount of tumor in the biopsy specimen, patients were not treated on the study.|at baseline|Of 252 participants analyzed, the assay correctly predicted the tissue of origin in 247 patients (98%). The predicted tissue of origin could not be determined in 5 participants (2%).||participants|||Number
773973|NCT00737243|Primary|Overall Survival|Defined as the elapsed time from the start of treatment to the date of death from any cause or lost to follow-up. Participants lost to follow up were censored as of the last date known to be alive.|every 6-8 weeks (2 cycles) until death from any cause or lost to follow up, projected 18 months|Of 223 treated patients: 194 received assay-directed therapy; 29 received empiric CUP therapy. The 194 patients who received assay-directed therapy were separated into groups based on predicted responsiveness of the tumor type for further analysis.||months||95% Confidence Interval|Median
773974|NCT00737282|Primary|To Assess the Safety of Proellex Administered Once Daily for Three Treatment Cycles (4 Months Each Cycle)||12 months|Study prematurely terminated|||||
773975|NCT00737360|Secondary|Safety|Toxicities were evaluated at each course of therapy using the CTCAE ver. 3.0 or a non-CTC grading scale for toxicities that were not covered by the NCI CTC.|Monitor patients for untoward medical events from the time of signed informed consent form, including toxicities from previous treatment and any ongoing or newly reported AEs or SAEs during the 30 days after the last dose of study medication.|All patients who received at least 1 dose of TAS-106 were the primary population for the safety evaluation.||number of participants|||Number
773976|NCT00737360|Secondary|Overall Survival|Patient survival for both subgroups was followed up every 2 months until 28 Feb 2011.|12 months after enrollment of the last patient|||day||95% Confidence Interval|Median
773977|NCT00737360|Secondary|Antitumor Activity|"Antitumor activity was evaluated by measuring the rate of objective response using the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. Per RECIST Criteria (V1.0) and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR)= CR + PR., or similar text that was as accurate and appropriate."|Obtain a contrast-enhanced CT scan of the chest, abdomen and pelvis (if clinically indicated) within 28 days prior to study entry and repeat at the end of every 2 courses thereafter.|Antitumor activity was the rate of best overall objective responses(complete response + partial response).||participants|||Number
773978|NCT00737360|Primary|Progression Free Survival(PFS)|PFS was calculated as days from the date of registration until the earliest date of documented disease progression, death, or censoring event.|From the date of registration until the earliest date of documented disease progression, death, or censoring event.|One patient enrolled was discontinued without any post-baseline tumor assessment, therefore, 26 patients were included in the efficacy analyzes.||day||95% Confidence Interval|Median
773979|NCT00737438|Primary|Overall Response Will be Characterized by the Patient's FDG-PET Scan|A good early FDG Response is a reduction in FDG uptake on the week 3 PET scan of > or = to 35% from baseline. An FDG PET non-responder will be defined as having a decrease of < 35% on the week 3 PET scan compared with baseline.|2 years|||participants|||Number
773980|NCT00737464|Secondary|Mean Values of Serum Sodium and Serum Potassium Over Time|Mean values of serum sodium and serum potassium were reported.|At Weeks -2, 4, 8, and 12|Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.||millimole per liter||Standard Deviation|Mean
773981|NCT00737464|Secondary|Mean Values of Serum Creatinine, Blood Urea Nitrogen, Serum Phosphate and Serum Bilirubin Over Time|Mean values of serum creatinine, blood urea nitrogen (BUN), serum phosphate and serum bilirubin were reported.|At Weeks -2, 4, 8, and 12|Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.||miligram per deciliter||Standard Deviation|Mean
773982|NCT00737464|Secondary|Mean Values of Aspartate Aminotransferase, Alanine Transaminase and Serum Alkaline Phosphatase Over Time|Mean values of aspartate aminotransferase (AST), alanine transaminase (ALT) and serum alkaline phosphatase were reported.|At Weeks -2, 4, 8, and 12|Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.||units per litre||Standard Deviation|Mean
773983|NCT00737464|Secondary|Mean Values of Serum Albumin and Serum Globulin Over Time|Mean values of serum albumin and serum globulin were reported.|At Weeks -2, 4, 8, and 12|Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.||gram per deciliter||Standard Deviation|Mean
773984|NCT00737464|Secondary|Mean Values of Transferrin Saturation Over Time|Mean values of Transferrin Saturation (TSAT) were reported.|At Weeks -2, 4, 8, and 12|Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.||Percentage||Standard Deviation|Mean
773985|NCT00737464|Secondary|Mean Values of Transferrin Over Time|Mean values of transferrin were reported.|At Weeks -2, 4, 8, and 12|Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.||miligram per mililiter||Standard Deviation|Mean
773986|NCT00737464|Secondary|Mean Values of Serum Ferritin Over Time|Mean values of serum ferritin were reported.|At Weeks -2, 4, 8, and 12|Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.||nanogram per mililiter||Standard Deviation|Mean
773987|NCT00737464|Secondary|Mean Values of Iron Parameters (Serum Iron and Total Iron Binding Capacity) Over Time|Mean values of serum iron and total iron binding capacity (TIBC) were reported.|At Weeks -2, 4, 8, and 12|Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.||microgram per deciliter||Standard Deviation|Mean
773988|NCT00737464|Secondary|Mean Corpuscular Volume Levels Over Time|Mean corpuscular volume (MCV) is a measure of the average red blood cell volume. MCV levels at Weeks -2, 4, 8, and 12 were reported.|At Weeks -2, 4, 8, and 12|Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.||femtoliters||Standard Deviation|Mean
773989|NCT00737464|Secondary|Mean Values of Hypochromic Red Blood Cells Over Time|Mean values of hypochromic red blood cells (RBCs) at Weeks -2, 4, 8, and 12 were reported.|At Weeks -2, 4, 8, and 12|Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.||Percentage of RBCs||Standard Deviation|Mean
773990|NCT00737464|Secondary|Mean Values of White Blood Cells and Platelets Over Time|Mean values of white blood cells (WBCs), and platelets at Weeks -2, 4, 8, and 12 were reported.|At Weeks -2, 4, 8, and 12|Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.||Per cubic millimeter||Standard Deviation|Mean
773991|NCT00737464|Secondary|Number of Participants With Abnormal Electrocardiogram|Participants with abnormal electrocardiogram were reported.|At Week -2 and Week 12|Safety population included all enrolled participants who received at least one dose of study drug. n = the number of participants analyzed at a given time point.||Number of participants|||Number
773992|NCT00737464|Secondary|Mean Change From Baseline in Blood Pressure (Systolic Blood Pressure and Diastolic Blood Pressure) Over Time|Mean change from Baseline (Week -2) to end of the treatment (Week 12) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) before and after dialysis was reported. Baseline measure was considered as (Week -2) evaluation for this parameter.|From Baseline (Week -2) to Weeks -1, 0, 1, 2, 4, 6, 8, 10, and 12|Safety population included all enrolled participants who received at least one dose of study drug. n = the number of participants analyzed at a given time point.||mmHg||Standard Deviation|Mean
773993|NCT00737464|Secondary|Mean Change From Baseline in Heart Rate Over Time|Mean change from Baseline (Week -1) to end of the treatment (Week 12) in heart rate was reported. Baseline measure was considered as (Week -1) evaluation for this parameter.|From Baseline (Week -1) to Weeks 0, 1, 2, 4, 6, 8, 10, and 12|Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.||Beats per minute (bpm)||Standard Deviation|Mean
773994|NCT00737464|Secondary|Number of Participants With Treatment Emergent Adverse Events, Serious Adverse Events and Deaths|Participants with treatment emergent adverse events (TEAEs), serious adverse events (SAEs) and deaths in the overall study were reported. An Adverse Event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to Week 14|Safety population included all enrolled participants who received at least one dose of study drug.||Number of participants|||Number
773995|NCT00737464|Secondary|Mean Time Participants Spent Having Hemoglobin Range of 10.0 to 12.0 g/dL|Mean time participants spent having hemoglobin range of 10.0 to 12.0 g/dL was reported. The reference Hb concentrations were based upon the mean of the assessments at Weeks -2, -1 and Week 0. The target range for assessment was set at the reference value hemoglobin +/- 1 gram per deciliter but not >12.0 g/dL and not <10.0 g/dL.|Up to Week 12|Per-protocol (PP) population comprised of participants who had received at least 1 dose of MIRCERA (Week 0) and for whom data for at least one follow-up variable was available and who had completed the study.||Weeks||Standard Deviation|Mean
774014|NCT00737529|Secondary|Time to Treatment Failure (TTF)|Time to treatment failure (TTF) was calculated from the start of study drug therapy to early discontinuation from treatment due to any cause, including disease progression, toxicity, or death and was based on site-reported data.|Up to 6 cycles (+/- 1 month) or discontinued before completing 6 cycles; data cut-off 02 July 2012; Median duration on study was 44.3 weeks and ranged from 0.6 to 175.1 weeks|An analysis of time to treatment failure was conducted in the ITT population||months||95% Confidence Interval|Median
773996|NCT00737464|Secondary|Mean Hemoglobin Concentration Between Stability Verification Period (Weeks -2 to -1) and Treatment Period (Weeks 8 to 12)|The mean change in Hb concentration between reference stability verification period (SVP) and in last 4 weeks (Weeks 8 to 12) of treatment period (TP) was reported. Duration for SVP was 2 weeks followed by treatment period of 12 weeks. The reference Hb concentrations were based upon the mean of the assessments at Weeks -2, -1 and Week 0. The target range for assessment was set at the reference value hemoglobin +/- 1 g/dL but not >12.0 g/dL and not <10.0 g/dL.|SVP (Weeks -2 to -1) and TP (Weeks 8 to 12)|Per-protocol (PP) population comprised of participants who had received at least 1 dose of MIRCERA (Week 0) and for whom data for at least one follow-up variable was available and who had completed the study.||gm/dL||Standard Deviation|Mean
773997|NCT00737464|Primary|Percentage of Participants Maintaining Mean Hemoglobin Levels Within the Target Range During the Last 4 Weeks of the Treatment Period (Weeks 8 to 12)|Participants maintaining mean hemoglobin (Hb) concentration within the target range i.e. 10.0 – 12.0 gram per deciliter (g/dL) during last 4 weeks (Weeks 8 to 12) of treatment period (TP) were reported. Total duration for treatment period was 12 weeks. Stability verification period of 2-weeks was conducted before treatment period. The reference Hb concentrations were based upon the mean of the assessments at Weeks -2, -1 and Week 0. The target range for assessment was set at the reference value Hb +/- 1 g/dL but not >12.0 g/dL and not <10.0 g/dL.|Weeks 8 to 12 (Last 4 weeks of treatment period)|Per-protocol (PP) population comprised of participants who had received at least 1 dose of MIRCERA (Week 0) and for whom data for at least one follow-up variable was available and who had completed the study.||Percentage of participants||95% Confidence Interval|Number
773998|NCT00737477|Secondary|Percentage of Participants Requiring Blood Transfusions|The percentage of participants who received at least one red blood cell transfusion during the overall treatment period (Weeks 0 to 48) was calculated.|Weeks 0 to 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided sufficient data."||percentage of participants|||Number
773999|NCT00737477|Secondary|Percent Change in Dose of Mircera/CERA by Study Week|Study drug administration occurred monthly during treatment (Weeks 0 to 48), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during the initial 4-week screening period. Subsequent doses could be adjusted on the basis of Hb levels or other modification criteria. The percent difference in dose from the previous week was calculated at each visit as [(current dose minus previous week dose) divided by previous week dose] multiplied by 100, and averaged among all participants.|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided sufficient data. The number of participants who provided sufficient data for each analysis at each timepoint (n) is shown in the table."||percent change in dose||Standard Deviation|Mean
774000|NCT00737477|Secondary|Absolute Change in Dose of Mircera/CERA by Study Week|Study drug administration occurred monthly during treatment (Weeks 0 to 48), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during the initial 4-week screening period. Subsequent doses could be adjusted on the basis of Hb levels or other modification criteria. The absolute difference in dose from the previous week was calculated at each visit and averaged among all participants.|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided sufficient data. The number of participants who provided sufficient data for each analysis at each timepoint (n) is shown in the table."||mcg||Standard Deviation|Mean
774001|NCT00737477|Secondary|Number of Dose Adjustments of Mircera/CERA|Study drug administration occurred monthly during treatment (Weeks 0 to 48), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during the initial 4-week screening period. Subsequent doses could be adjusted on the basis of Hb levels or other modification criteria. The number of dose adjustments performed for each participant was averaged among all participants for Weeks 4 to 20, Weeks 24 to 48, and Weeks 4 to 48.|Weeks 4 to 20, Weeks 24 to 48, Weeks 4 to 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided sufficient data. The number of participants who provided sufficient data within each timeframe (n) is shown in the table."||dose adjustments||Standard Deviation|Mean
774002|NCT00737477|Secondary|Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA|Study drug administration occurred monthly during treatment (Weeks 0 to 48), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during the initial 4-week screening period. Subsequent doses could be adjusted on the basis of Hb levels or other modification criteria. The percentage of participants who required any dose adjustment (including decreased dose, increased dose, and dose not performed) was calculated for Weeks 4 to 20, Weeks 24 to 48, and Weeks 4 to 48.|Weeks 4 to 20, Weeks 24 to 48, Weeks 4 to 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided sufficient data. The number of participants who provided sufficient data for each analysis within each timeframe (n) is shown in the table."||percentage of participants|||Number
774003|NCT00737477|Secondary|Percentage of Participants With Down Excursions|"Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA during the DAP, EEP, and follow-up. Excursions were defined as half of one full cycle, or an increase (up excursions) or decrease (down excursions) in Hb >1.5 g/dL lasting longer than 4 weeks. The percentage of participants with at least one down excursion was calculated for Weeks 4 to 16, Weeks 16 to 24, and Weeks 24 to 44."|Weeks 4 to 16, Weeks 16 to 24, Weeks 24 to 44|"ITT Population. The Number of Participants Analyzed reflects the total number of participants with at least one down excursion."||percentage of participants|||Number
774004|NCT00737477|Secondary|Percentage of Participants With Up Excursions|"Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA during the DAP, EEP, and follow-up. Excursions were defined as half of one full cycle, or an increase (up excursions) or decrease (down excursions) in Hb >1.5 g/dL lasting longer than 4 weeks. The percentage of participants with at least one up excursion was calculated for Weeks 4 to 16, Weeks 16 to 24, and Weeks 24 to 44."|Weeks 4 to 16, Weeks 16 to 24, Weeks 24 to 44|"ITT Population. The Number of Participants Analyzed reflects the total number of participants with at least one up excursion."||percentage of participants|||Number
774283|NCT00746590|Primary|Overall Best Tumor Response Rate (Proportion of Subjects With Complete or Partial Response) as Defined by Modified RECIST||every 6 weeks until progression|Study was terminated prematurely after only 1 patient was enrolled. The patient died one month after the initial dose of Prolarix, but his death was unrelated to Prolarix administration.||participants||Standard Deviation|Mean
774005|NCT00737477|Secondary|Percentage of Participants With Cycles or Excursions|"Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. Cycles were defined as a change in Hb greater than (>) 1.5 g/dL lasting longer than 8 weeks. Excursions were defined as half of one full cycle, or an increase (up excursions) or decrease (down excursions) >1.5 g/dL lasting longer than 4 weeks according to Hb measurements collected during the study. The percentage of participants with at least one cycle or excursion during Weeks 4 to 44 was calculated."|Weeks 4 to 44|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided sufficient data."||percentage of participants|||Number
774006|NCT00737477|Secondary|Percentage of Participants With Hb Value Within Plus/Minus (±) 1 g/dL of Reference Hb and Within the Target Range by Study Visit|Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment screening period (Weeks -4 to 0). Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. The percentage of participants who had average Hb during the EEP (Weeks 16 to 24) and follow-up (Weeks 28 to 48) in the target range (10 to 12 g/dL) and within ±1 g/dL of their individual reference Hb was determined by study visit.|Baseline and Weeks 16, 20, 24, 28, 32, 36, 40, 44, 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided sufficient data. The number of participants who provided sufficient data at each timepoint (n) is shown in the table."||percentage of participants|||Number
774007|NCT00737477|Secondary|Time Spent in the Target Range for Hb During the EEP and the Overall Treatment Period|Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. Time spent in the target range (10 to 12 g/dL) was defined as time from first on-target Hb measurement to time of last known on-target Hb measurement, as collected during the EEP (Weeks 16 to 24) and the overall treatment period (Weeks 0 to 48). Time spent in the target range was averaged among all participants and expressed in weeks.|Weeks 16 to 24 and Weeks 0 to 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided sufficient data. The number of participants who provided sufficient data within each timeframe (n) is shown in the table."||weeks||Standard Deviation|Mean
774008|NCT00737477|Secondary|Change in Hb Value From Baseline to the EEP|"Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment screening period (Weeks -4 to 0). Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. The average Hb during the EEP (Weeks 16 to 24) was calculated per participant and assessed against the reference value. The mean change in Hb value between reference (i.e., Baseline) Hb and the EEP average Hb was calculated and expressed in g/dL."|Baseline and Weeks 16 to 24|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided sufficient data."||g/dL||Standard Deviation|Mean
774009|NCT00737477|Secondary|Percentage of Participants With Hb Values Within Target Range During the EEP|During the EEP (Weeks 16 to 24), participants provided a total of three pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. The percentage of participants who had at least one, two, or all three Hb values during the EEP in the target range (10 to 12 g/dL) was determined.|Weeks 16 to 24|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided sufficient data for at least one Hb value. The number of participants who provided sufficient data for each analysis (n) is shown in the table."||percentage of participants|||Number
774010|NCT00737477|Primary|Percentage of Participants Who Maintained Average Hb Value Within Target Range During the EEP|Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. The average Hb during the EEP (Weeks 16 to 24) was calculated per participant and assessed against the target range. The percentage of participants who had average Hb during the EEP in the target range (10 to 12 g/dL) was determined as the primary endpoint. The 95 percent (%) confidence interval (CI) was calculated using the Pearson-Clopper method for exact confidence bounds.|Weeks 16 to 24|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided sufficient data."||percentage of participants||95% Confidence Interval|Number
774011|NCT00737529|Secondary|Summary of Participants With Treatment Emergent Adverse Events (TEAEs)|Adverse events were assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3: Following is the scale: Grade 1 = Mild Adverse Event (AE), Grade 2 = Moderate AE, Grade 3 = Severe and Undesirable AE, Grade 4 = Life-threatening or Disabling AE, and Grade 5 = Death; Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above. after the first dose of study drug and within 28 days after the last dose. A TEAE is defined as any AE occurring or worsening on or after the first dose of study drug and within 28 days after the last dose of study drug.|From the first dose of Lenalidomide through cycle 6 plus 28 days of last dose of Lenalidomide (maximum duration of study drug was 1006 days) and up to data cut off 02 July 2012|The Safety Population (received at least one dose of Lenalidomide) was used for all safety analysis and was identical to the ITT population.||participants|||Number
774012|NCT00737529|Secondary|Overall Survival (OS)|Kaplan Meier estimates of OS was calculated from the time the first dose of study drug to death from any cause. Participants who had not died were censored at the last date the participant was known to be alive.|Up to 6 cycles (+/- 1 month) or discontinued before completing 6 cycles; data cut-off 02 July 2012; Median duration on study was 44.3 weeks and ranged from 0.6 to 175.1 weeks|An analysis of overall survival was conducted in the ITT population||months||95% Confidence Interval|Median
774013|NCT00737529|Secondary|Progression-free Survival (PFS)|Kaplan Meier estimates of PFS was defined as the start of study drug therapy to the first observation of disease progression or death due to any cause, whichever comes first. If a participant had not progressed or died, PFS was censored at the time of last adequate assessment when the participant was known not to have progressed. For participants who received other anti-lymphoma therapy with no evidence of progression, PFS was censored at time of last adequate tumor assessment with no evidence of progression prior to the start of new anti-lymphoma treatment.|Up to 6 cycles (+/- 1 month) or discontinued before completing 6 cycles; and/or of the data-cut off of 02 July 2012; Median duration on study was 44.3 weeks and ranged from 0.6 to 175.1 weeks|An analysis of progression free survival was conducted in the ITT population||months||95% Confidence Interval|Median
774015|NCT00737529|Secondary|Time to Progression (TTP)|Kaplan Meier estimate of time to progression was calculated as time from the start of the study drug therapy to the first observation of disease progression. Participants who died without progression were censored at the date of death; otherwise, the censoring rules presented above for PFS applied to the analysis of TTP. Progressive Disease(PD): Appearance of new lesion or increase by ≥50% from previously involved sites from nadir|Up to 6 cycles (+/- 1 month) or discontinued before completing 6 cycles; data cut-off 02 July 2012; Median duration on study was 44.3 weeks and ranged from 0.6 to 175.1 weeks|An analysis of time to progression was conducted in the ITT population||months||95% Confidence Interval|Median
774016|NCT00737529|Secondary|Time to Complete Response (CR+CRu)|Time to Complete Response (CR+CRu) was defined as the time from the first dose of study drug to the date of the first occurrence of at least CRu and was calculated only for participants with CR or CRu.|Up to 6 cycles (+/- 1 month) or discontinued before completing 6 cycles; data cut-off 02 July 2012: Median duration on study was 44.3 weeks and ranged from 0.6 to 175.1 weeks|Participants in the ITT population with a CR. The minimum and maximum are referenced in the measure of dispersion under full range.||months||Full Range|Median
774017|NCT00737529|Secondary|Duration of Complete Response (DoCR) (CR+CRu)|Kaplan Meier estimates for the duration of CR/CRu was calculated from the date of the first occurrence of CR/CRu to the date of documented disease progression or death (without documented progression) for participants who obtained a CR/CRu; participants who had not progressed (or died) were censored at the last valid assessment.|Up to 6 cycles (+/- 1 month) or discontinued before completing 6 cycles; data cut-off 02 July 2012; Median duration on study was 44.3 weeks and ranged from 0.6 to 175.1 weeks|Participants in the ITT population with a CR.||months||95% Confidence Interval|Median
774018|NCT00737529|Primary|Duration of Response (DoR)|Kaplan Meier estimates for the duration of response (DoR) was calculated from the date of the first occurrence of initial response for responders (demonstrating evidence of at least a PR) to the date of first documented disease progression (any new lesion or increase by ≥ 50% of previously involved sites from nadir) or death (without documented progression) for participants who responded; participants who had not progressed (or died) were censored at the last valid assessment.|Up to 6 cycles (+/- 1 month) or discontinued before completing 6 cycles and/or data cut-off of 02 July 2012: Median duration on study was 44.3 weeks and ranged from 0.6 to 175.1 weeks|Participants in the ITT population with an overall response||months||95% Confidence Interval|Median
774019|NCT00737529|Secondary|Percentage of Participants With a Complete Response (CR) /Complete Response Unconfirmed (CRu)|The percentage of participants whose best response was CR or CRu. Participants who had discontinued before CR/CRu was observed, or changed to other antilymphoma treatments before a CR/CRu response had been observed, were considered as non-responders. CR is defined as the disappearance of all clinical and radiographic evidence of disease; CRu is defined as a CR, with a 1) residual lymph node mass >1.5 cm that has decreased by 75% in the sum of the product of the diameters (SPD). Individual nodes previously confluent decreased by more than 75% in the SPD compared with original mass; 2) indeterminate bone marrow; Non-responders are participants who discontinue before any post-baseline efficacy assessments.|Up to 6 cycles (+/- 1 month) or discontinued before completing 6 cycles; Data cut-off 02 July 2012; Median duration on study was 44.3 weeks and ranged from 0.6 to 175.1 weeks|An analysis of the complete response rate (CCR) was conducted using the IRC in the ITT population||percentage of participants||95% Confidence Interval|Number
774020|NCT00737529|Secondary|Time to Response (TTR)|TTR was defined as the time from first dose of study drug to the date of the first response (having at least a PR) and was calculated only for responding participants.|Up to 6 cycles (+/- 1 month) or discontinued before completing 6 cycles; data cut-off 02 July 2012: Median duration on study was 44.3 weeks and ranged from 0.6 to 175.1 weeks|An analysis of time to response was calculated only for responding participants. The minimum and maximum are referenced in the measure of dispersion under full range.||months||Full Range|Median
774021|NCT00737529|Primary|Percentage of Participants With an Overall Response|Overall Response Rate (ORR) was defined as the percentage of participants whose best response was Complete Response (CR), Complete Response unconfirmed (CRu) or Partial Response (PR). Participants who had discontinued before any response has been observed, or changed to other anti-lymphoma treatments before response had been observed, were considered as non-responders. Tumor Response was assessed by a modification of the International Lymphoma Workshop Response Criteria, IWRC, Cheson, 1999); CR is defined as the disappearance of all clinical and radiographic evidence of disease; CRu is defined as a CR, with a 1) residual lymph node mass >1.5 cm that has decreased by 75% in the sum of the product of the diameters (SPD). Individual nodes previously confluent decreased by more than 75% in the SPD compared with original mass; 2) indeterminate bone marrow; PR = is defined ≥50% decrease in 6 largest nodes or nodal masses|Up to 6 cycles (+/- 1 month) or discontinued before completing 6 cycles; data cut-off 02 July 2012; Median duration on study was 44.3 weeks and ranged from 0.6 to 175.1 weeks|An analysis of overall response was conducted in the Intent To Treat population (ITT) defined as all enrolled participants who received at least one dose of study drug.||percentage of participants||95% Confidence Interval|Number
774022|NCT00737568|Secondary|Development of Drug-resistant Mutations (DRMs)|The development of DRMs was summarized, either as development of new DRMs or enrichment of existing DRMs.|Baseline to Week 240|Full Analysis Set||participants|||Number
774023|NCT00737568|Secondary|Percent Change From Baseline in BMD of the Hip at Weeks 24, 48, 72, 96, 144, 192, and 240|BMD is calculated as g/cm^2; the mean (SD) percentage change is presented.|Baseline; Weeks 24, 48, 72, 96, 144, 192, and 240|Participants in the Safety Analysis Set with hip BMD measurements at the given time point were included in the analysis.||percentage change||Standard Deviation|Mean
774024|NCT00737568|Secondary|Percent Change From Baseline in Bone Mineral Density (BMD) of the Spine at Weeks 24, 48, 72, 96, 144, 192, and 240|BMD is calculated as grams per cubic centimeter (g/cm^2); the mean (SD) percentage change is presented.|Baseline; Weeks 24, 48, 72, 96, 144, 192, and 240|Participants in the Safety Analysis Set (randomized and received at least 1 dose of study drug) with spine BMD measurements at the given time point were included in the analysis.||percentage change||Standard Deviation|Mean
774025|NCT00737568|Secondary|Percentage of Participants With Virologic Breakthrough at Weeks 48, 96, 144, 192, and 240|The percentage of participants with virologic breakthrough at the given time point was summarized. Virologic breakthrough was defined as having two consecutive 1.0 log10 or greater increases in serum HBV DNA from on-treatment nadir, or two consecutive HBV DNA values ≥ 400 copies/mL after being < 400 copies/mL.|Baseline; Weeks 48, 96, 144, 192, and 240|Full Analysis Set; the missing-equals-excluded method was used in which participants with missing data were excluded from the analysis.||percentage of participants|||Number
774026|NCT00737568|Secondary|Percentage of Participants With Seroconversion to Antibody Against HBV Surface Antigen (Anti-HBs) at Weeks 48, 96, 144, 192, and 240|The percentage of participants with seroconversion to anti-HBs at the given time point was summarized. Seroconversion to anti-HBs was defined as change of detectable antibody to HBsAg from negative to positive.|Baseline; Weeks 48, 96, 144, 192, and 240|Full Analysis Set, missing = failure method||percentage of participants|||Number
774027|NCT00737568|Secondary|Percentage of Participants With HBV Surface Antigen (HBsAg) Loss at Weeks 48, 96, 144, 192, and 240|The percentage of participants with HBsAg Loss at the given time point was summarized. Loss of HBsAg was defined as change of detectable HBsAg from positive to negative.|Baseline; Weeks 48, 96, 144, 192, and 240|Full Analysis Set, missing = failure method||percentage of participants|||Number
774028|NCT00737568|Secondary|Percentage of Participants With Seroconversion to Antibody Against HBeAg (Anti-HBe) at Weeks 48, 96, 144, 192, and 240|The percentage of participants who were HBeAg positive at baseline and who had seroconversion to anti-HBe at the given time point was summarized. Seroconversion to anti-HBe was defined as change of detectable antibody to HBeAg from negative to positive.|Baseline; Weeks 48, 96, 144, 192, and 240|Participants in the Full Analysis Set who were HBeAg positive at baseline were analyzed using the missing = failure method.||percentage of participants|||Number
774029|NCT00737568|Secondary|Percentage of Participants With HBeAg Loss at Weeks 48, 96, 144, 192, and 240|The percentage of participants who were HBeAg positive at baseline and who had HBeAg Loss at the given time point was summarized. Loss of HBeAg was defined as change of detectable HBeAg from positive to negative.|Baseline; Weeks 48, 96, 144, 192, and 240|Participants in the Full Analysis Set who were HBeAg positive at baseline were analyzed using the missing = failure method.||percentage of participants|||Number
774030|NCT00737568|Secondary|Percentage of Participants With Normal ALT at Weeks 48, 96, 144, 192, and 240|Normal ALT was defined as having a value less than or equal to the ULN. The ULN was 43 U/L for males and 34 U/L for females aged 18 to < 69, and 35 U/L for males and 32 U/L for females aged ≥ 69.|Weeks 48, 96, 144, 192, and 240|Full Analysis Set, missing = failure method||percentage of participants|||Number
774031|NCT00737568|Secondary|HBV DNA Level at Weeks 48, 96, 144, 192, and 240||Weeks 48, 96, 144, 192, and 240|Full analysis set; participants with HBV DNA measurements at the given time point were included in the analysis.||log10 copies/mL||Standard Deviation|Mean
774032|NCT00737568|Secondary|Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 96, 144, 192, and 240||Weeks 48, 96, 144, 192, and 240|Full Analysis Set, missing = failure method||percentage of participants|||Number
774033|NCT00737568|Secondary|Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 144, 192, and 240||Weeks 48, 144, 192, and 240|Full Analysis Set, missing = failure method||percentage of participants|||Number
774034|NCT00737568|Primary|Percentage of Participants With HBV DNA < 400 Copies/mL at Week 96||Week 96|Full Analysis Set: participants were randomized and received at least 1 dose of study drug. The missing = failure method was used in which participants with missing data were considered to have failed to achieve the endpoint.||percentage of participants|||Number
774035|NCT00737594|Primary|Change From Baseline in Hepatic Venous Pressure Gradient (HVPG) After Four (4) Weeks of Treatment|Study terminated early, data was not analyzed.|4 weeks||||||
774036|NCT00737633|Secondary|Percent Weight Change From Baseline to Week 72||Baseline to 72 weeks|Intent-to-treat (ITT)||percent change||Standard Deviation|Mean
774037|NCT00737633|Primary|Change in HbA1c From Baseline to Week 72||Baseline to 72 weeks|Intent-to-treat (ITT)||percent change||Standard Deviation|Mean
774054|NCT00737711|Secondary|Mean Serum Alkaline Phosphatase Over Time|Mean values of serum alkaline phosphatase are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.||U/L||Standard Deviation|Mean
774055|NCT00737711|Secondary|Mean Alanine Aminotransferase Over Time|Mean values of alanine aminotransferase are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.||U/L||Standard Deviation|Mean
774056|NCT00737711|Secondary|Mean Aspartate Transaminase Over Time|Mean values of aspartate transaminase are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.||Units/Liter (U/L)||Standard Deviation|Mean
774057|NCT00737711|Secondary|Mean Serum Bilirubin Over Time|Mean values of serum bilirubin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.||mg/dL||Standard Deviation|Mean
774058|NCT00737711|Secondary|Mean Serum Phosphate Over Time|Mean values of serum phosphate are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.||mg/dL||Standard Deviation|Mean
774059|NCT00737711|Secondary|Mean Serum Sodium Over Time|Mean values of serum sodium are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.||mmol/L||Standard Deviation|Mean
774060|NCT00737711|Secondary|Mean Serum Potassium Over Time|Mean values of serum potassium are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.||millimoles per liter (mmol/L)||Standard Deviation|Mean
774061|NCT00737711|Secondary|Mean Blood Urea Nitrogen Over Time|Mean values of blood urea nitrogen (BUN) are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.||mg/dL||Standard Deviation|Mean
774062|NCT00737711|Secondary|Mean Serum Creatinine Over Time|Mean values of serum creatinine are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.||mg/dL||Standard Deviation|Mean
774063|NCT00737711|Secondary|Mean Serum Globulin Over Time|Mean values of serum globulin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.||g/dL||Standard Deviation|Mean
774064|NCT00737711|Secondary|Mean Serum Albumin Over Time|Mean values of serum albumin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.||g/dL||Standard Deviation|Mean
774065|NCT00737711|Secondary|Mean Transferrin Saturation Over Time|Transferrin saturation (TSAT) measured as a percentage, is a medical laboratory test. It is calculated as serum iron/ total iron-binding capacity x 100. Mean values of transferrin saturation at Baseline (Week 0), Week 4, Week 10, and Week 16 are presented.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.||Percentage of transferrin saturation||Standard Deviation|Mean
774066|NCT00737711|Secondary|Mean Total Iron-binding Capacity Over Time|Mean values of total iron-binding capacity are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.||mcg/dL||Standard Deviation|Mean
774067|NCT00737711|Secondary|Mean Transferrin Over Time|Mean values of serum transferrin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.||milligram per deciliter (mg/dL)||Standard Deviation|Mean
774068|NCT00737711|Secondary|Mean Serum Ferritin Over Time|Mean values of serum ferritin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.||nanogram /milliliter (ng/mL)||Standard Deviation|Mean
774069|NCT00737711|Secondary|Mean Serum Iron Over Time|Mean values of serum iron are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.||microgram/deciliter (mcg/dL)||Standard Deviation|Mean
774070|NCT00737711|Secondary|Mean Platelet Count Over Time|Mean values of platelet count are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.||cells per cubic millimeter||Standard Deviation|Mean
774071|NCT00737711|Secondary|Mean Hypochromic Red Blood Cells Over Time|Mean values of hypochromic RBCs are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.||cells per cubic millimeter||Standard Deviation|Mean
774072|NCT00737711|Secondary|Mean Value of Mean Corpuscular Volume Over Time|Mean corpuscular volume (MCV) is a measure of the average volume of red blood corpuscles (RBCs) and is calculated by dividing hematocrit value by the concentration of RBCs. Mean values of MCV are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. Reference range of mean corpuscular volume is 80-96 femtoliter (fL) per red blood cell.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.||Femtoliter||Standard Deviation|Mean
774073|NCT00737711|Secondary|Mean White Blood Cell Count Over Time|The mean values of white blood cells are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.||cells per cubic millimeter||Standard Deviation|Mean
774074|NCT00737711|Secondary|Number of Participants With Reports of Anti-Epoetin Antibodies|Participants were assessed for the presence of Anti-Epoetin antibodies for MIRCERA.|Up to Week 16|The ITT population included all participants who receive at least one dose of study drug.||Participants|||Number
774075|NCT00737711|Secondary|Number of Participants With Reports of Blood Transfusions|Indications for blood transfusions were acute blood loss (bleeding), lack of treatment response or treatment failure, or other reasons.|Up to Week 16|The ITT population included all participants who receive at least one dose of study drug. Participants available at the time of assessment were included.||Participants|||Number
787069|NCT00839956|Secondary|Median Follow-up Survival for All Patients||Up to 5 years|||years||Full Range|Median
774076|NCT00737711|Secondary|Number of Participants With Abnormal Electrocardiogram|Twelve-lead electrocardiogram (ECG) was recorded for the participants. The number of participants with abnormal ECG is presented.|Up to Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.||Participants|||Number
774077|NCT00737711|Secondary|Number of Participants With Adverse Events, Serious Adverse Events and Deaths|An adverse event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. A serious adverse event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution. An SAE is any AE that can result in death or is life-threatening or required participant hospitalization or prolongation of existing hospitalization or results in persistent or significant disability/incapacity; or is a congenital anomaly/birth defect; or is medically significant or requires intervention to prevent one or other of the outcomes listed above|Up to Week 18|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number.||Participants|||Number
774078|NCT00737711|Secondary|Percentage of Participants With Average Hemoglobin Concentration Between 10.0-12.0 Gram/Deciliter From Week 12 to Week 16|The Hb concentration was recorded for all the participants at enrollment and different time points throughout the study up to Week 16. The percentage of participants achieving Hb levels within target range of 10.0-12.0 g/dL during the last 4 weeks of the TP is presented.|Week 12 to Week 16|The ITT population included all participants who received at least one dose of the study drug.||percentage of participants||95% Confidence Interval|Number
774079|NCT00737711|Secondary|Mean Time Spent in the Hemoglobin Range of 10.0-12.0 Gram/Deciliter From Week 12 to Week 16|The Hb concentration was recorded for all the participants at enrollment and different time points throughout the study up to Week 16. The mean time spent (in weeks) by the participants in the target range (10–12 g/dL) during the last 4 weeks of the TP is presented.|Week 12 to Week 16|The ITT population included all participants who received at least one dose of the study drug. Data for participants available at the time of assessment is presented.||Weeks||Standard Deviation|Mean
774080|NCT00737711|Secondary|Mean Time Required to Achieve Blood Hemoglobin Levels Within Target Range of 10.0-12.0 Gram/Deciliter|Achievement of blood Hb levels within target range of 10.0-12.0 g/dL was considered as achievement of response. The mean time required to achieve the Hb target range is presented in weeks.|Up to Week 16|The ITT population included all participants who received at least one dose of the study drug. Data for participants available at the time of assessment is presented.||Weeks||Standard Deviation|Mean
774081|NCT00737711|Primary|Mean Change in Hemoglobin Concentration From Baseline to Week 16 of the Treatment Period|The difference between the mean Hemoglobin (Hb) value at the last visit (Week 16) of the treatment period (TP) and at Baseline (Week 0) is presented. TP was from Baseline to Week 16.|Baseline (Week 0) and Week 16|The intent-to-treat (ITT) population included all participants who received at least one dose of the study drug. Data for participants available at the time of assessment is presented.||gram/deciliter (g/dL)||Standard Deviation|Mean
774082|NCT00737737|Secondary|Is Placebo Analgesia Associated With a Similar Hormonal Response as Elicited by an Opioid Analgesic?||4 weeks|||ng/ml|||Number
774083|NCT00737737|Primary|Is Chronic Opioid Treatment Associated With Changes in Adrenocorticotropic Hormone (ACTH), Cortisol, Luteinizing Hormone (LH) and Testosterone Secretion?||4 weeks|||ng/ml|||Number
774084|NCT00743249|Secondary|Percentage of Subjects Retaining the Stent at Month 3|At all study visits the investigator conducted a slit lamp examination to determine whether the canalicular stent was present.|Month 3|Intent to treat||Percentage of subjects|||Number
774085|NCT00743249|Primary|Mean Retention Time|At all study visits the investigator conducted a slit lamp examination to determine whether the canalicular stent was present.|From baseline (Day 0) up to Month 3|Intent to treat||Days||Standard Deviation|Mean
774086|NCT00743262|Secondary|Device Life Time|Device life time of the Provox Vega in days for replacement for leakage through the device. This is expected to be short (average about 3 weeks) since the Provox Vega 22.5 was tested in patients who normally use a Provox ActiValve. (Provox ActiValve is a problem solving prostheses used in patients who need frequent replacement of regular Provox voice prostheses short that are made of the same materials as the Provox Vega 22.5.)|one year|||days||Standard Deviation|Mean
774087|NCT00743262|Secondary|Subjective Voice and Speech Quality|Subjective participant opinion using a structured questionnaire addressing intelligibility face to face and on the phone, loudness, pitch and fluency. Each question was measured on a four point scale. Scores were summated, best possible score is 5, worst possible score is 20.|3 weeks|||units on a scale||Standard Deviation|Mean
774088|NCT00743262|Primary|Short-term Feasibility Provox Vega 22.5 French|Number of participants in whom the voice prosthesis was considered feasible in the short-term with regards to clinical and technical aspects as judged by patient and investigator.|3 weeks|||Patients|||Number
774089|NCT00743275|Primary|Percentage of Participants With at Least a 4-Fold Rise in Hemagglutination Inhibition Antibody Titer Post-Vaccination With Fluzone Vaccine (Seroconversion)|Seroconversion was defined as a four-fold rise in titers or greater from baseline. If the baseline titer value is < 10, then 10 is used as the baseline value for the purposes of this calculation|21 days post-vaccination|Analysis of seroconversion was in the per-protocol population. (Participants that did not provide both pre- and post- vaccination serum samples within the specified time window were excluded from analysis)||Percentage of Participants|||Number
774090|NCT00743275|Primary|Percentage of Participants With at Least 1:40 Hemagglutination Inhibition Antibody Titer Post-Vaccination With Fluzone® Vaccine (Seroprotection)|Seroprotection was defined as post-vaccination titer value of ≥ 1:40.|21 days post-vaccination|Analysis of seroprotection was in the per-protocol population. (Participants that did not provide both pre- and post- vaccination serum samples within the specified time window were excluded from analysis)||Percentage of Participants|||Number
774091|NCT00743275|Primary|Geometric Mean Titers (GMTs) for the 3 Influenza Strains Pre- and Post-vaccination With Fluzone® Vaccine 2008-2009 Formulation||Day 0 and 21 days post-vaccination|Analysis of Geometric Mean Titers was in the per-protocol population. (Participants that did not provide both pre- and post- vaccination serum samples within the specified time window were excluded from analysis)||Titers||95% Confidence Interval|Geometric Mean
774092|NCT00743275|Primary|Number of Participants With at Least 1 Solicited Injection Site Solicited Systemic Reactions Post-vaccination With Fluzone® Vaccine.|Solicited Injection Site Reaction: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic Reaction: Fever (temperature), Headache, Malaise, Myalgia, and Shivering|Days 0-3 post-vaccination|Safety profile was assessed in the intent-to-treat (ITT) population||Participants|||Number
774093|NCT00743288|Primary|Overall Response Rate (ORR) and Clinical Benefit Rate (CBR) [ORR= Complete Response (CR) + Very Good Partial Response (VGPR) + Partial Response (PR)]; CBR=ORR + Minimal Response (MR)] Following Treatment With Panobinostat and Melphalan|Responses were evaluated according to criteria modified from those developed by Blade et al., 1998 The reference point for evaluating response improvement is the baseline. This baseline reference point is also valid when a patient has already achieved a response and transitions through into a better response grade.|24 months|||participants|||Number
774094|NCT00743288|Primary|MTD|Phase 1: to determine MTD of melphalan in combination with panobinostat to be used in the Phase 2 portion of the study|12 months|||mg/kg melphalan|||Number
774095|NCT00743288|Primary|Maximum Tolerated Dose (MTD)|Phase 1: to determine the MTD of panobinostat (LBH589) in combination with melphalan to be used in the Phase 2 portion of the study|12 months|MTD for Melphalan and Panobinostat was reached in the cohort of 6 participants who received 20 mg/daily LBH589 PO and melphalan PO at 0.05 mg/kg on days 1, 3 and 5 of week 1 of each cycle. Three additional patients were enrolled as part of the phase 2 expansion.||mg LBH589|||Number
774096|NCT00743288|Secondary|Time to Progression||Time from the start of treatment to progressive disease|All cohorts were analyzed||months||Full Range|Median
774097|NCT00743288|Secondary|Duration of Response||First evidence of PR or better (for overall response) and MR or better (for clinical benefit response) to start of disease progression or death|Only three patients had responses.||months||Full Range|Median
774098|NCT00743366|Primary|Measure of Relapse: Change in Puffs Chosen Between Baseline and Relapse Phase|"This is a measure of marijuana self-administration and relapse since each initial puff costs $10 and is a burden to overcome just to smoke.
Over each 3 day period, the puffs chosen by each participant is averaged for a single value."|Days 1-3 (Baseline) and Days 6-8 (Relapse Phase)|||Puffs||Standard Error|Mean
774099|NCT00743431|Primary|Occurrences of Infusion Reactions and Palmar-Plantar Erythrodysesthesia (PPE)|"Definitions in assessment of adverse event severity:
Mild: awareness of sign, symptom, or event, but easily
tolerated.
Moderate: discomfort enough to cause interference with usual
activity and may warrant intervention.
Severe: incapacitating with inability to do usual activities or
significantly affects clinical status, and warrants
intervention."|The observational program was conducted over a period of 2 years|Intent-to-treat (ITT) (N=214). This is also the Safety population.||Events|||Number
774100|NCT00743444|Secondary|Area Under the Plasma Concentration vs. Time Curve (AUCtau) During 0-12 Hours Post First Dose Calculated by the Log/Linear Trapezoidal Method.|The AUCtau was calculated for each patient in the period with AZD3355 treatment by the Log-Linear Trapezoidal Method. The descriptive geometric mean of the individual AUCtau values is reported here.|0-12 hours post first dose|Per Protocol Analysis Set (PP). From the safety analysis set with 27 patients, the PP excludes 2 patients since they discontinued prematurely from the study. Additionally, 1 patient was excluded from the pharmacokinetic analysis due to error in dose administration at dose 2.||μmol*hours / L||Standard Deviation|Geometric Mean
774101|NCT00743444|Secondary|Total Number Reflux Episodes 0-24 Hours Post First Dose|Number of reflux episodes assessed during the 24-hour ambulatory impedance-pH recording.|0-24 hours|Per Protocol Analysis Set (PP). From the safety analysis set with 27 patients, the PP excludes 2 patients since they discontinued prematurely from the study. Additionally, 4 patients were excluded from this analysis; 1 due to catheter placement problems, 1 due to error in dose administration, 2 due to insufficient impedance/pH recording time.||Episodes||95% Confidence Interval|Geometric Mean
774102|NCT00743444|Primary|Number of Transient Lower Esophageal Sphincter Relaxations (TLESRs) 0-3 Hours Post Meal, Post Third Dose|"The number of relaxations for each patient in each period was determined from manometric tracings according to previously published criteria (R.H. Holloway, R. Penagini and A.C. Ireland, Criteria for objective definition of transient lower esophageal sphincter relaxation, Am J Physiol 268 (1995), pp. G128-G133).
The analysis of the number of TLESRs was based on an analysis of variance (ANOVA) for log-transformed data. The 95% level confidence interval (CI) limits were transformed back to the original scale to give CIs for the geometric mean for each treatment."|0-3 hours post meal, post third dose|Per Protocol Analysis Set (PP). From the safety analysis set with 27 patients, the PP excludes 2 patients since they discontinued prematurely from the study. Additionally, 4 patients were excluded from the primary analysis; 1 due to catheter placement problems, 1 due to error in dose administration, 1 due to low LESP, 1 due to multiple swallowing.||Relaxations||95% Confidence Interval|Geometric Mean
774103|NCT00743483|Primary|The Absolute Difference Between Baseline and Treatment Coefficient of Fat Absorption (CFA)|"The absolute difference between baseline and treatment CFA, i.e. the change from the baseline level.
CFA was calculated as follows 100 x ((fat consumed - fat excreted)/fat consumed).
Fat consumed was determined from the weight of fat of the dietary intake during a 72 hour period during the final 3 days of the baseline and treatment period.
Fat excreted was determined from stool collected during the 72-hour periods and analyzed for fat using the Van de Kamer method.
The unit of CFA is %"|Final 3 days of baseline and treatment period|Per protocol||% CFA||Standard Deviation|Mean
774104|NCT00743509|Secondary|Median Overall Survival Time|Median overall duration of survival.|48 weeks|All patients who completed at least one 28 day cycle||days||95% Confidence Interval|Median
774105|NCT00743509|Primary|Number of Patients Alive Without Disease Progression|Patients who were evaluable for response to therapy, alive and without evidence of sarcoma disease progression. Target lesions followed were lesions that had progressed by World Health Organization (WHO) criteria. Disease progression is defined as a greater than or equal to 25% increase in the sum of the product of target lesions, or unequivocal progression of non-target lesions or the appearance of new tumor lesions >10mm.|6 months|Patients that tolerated and completed at least one 28 day cycle of therapy were considered evaluable||participants|||Number
774106|NCT00744653|Secondary|Safety and Toxicity||up to 1 year|per protocol||adverse events|Participants||Number
774107|NCT00744653|Secondary|Participants With Objective Response Evaluated With PET/CT|Participants with objective response evaluated with PET/CT. Objective Response evaluated with CT and PET/CT.|3, weeks, 8 weeks, and up to 6 months after treatment|per protocol||participants|||Number
774108|NCT00744653|Primary|Clinical Measure of Lesion Size.|Response was evaluated clinical using Response Evaluation Criteria in Solid Tumors (RECIST) guidelines and documented with digital photography. Number of patients with objective response evaluated with clinical measure of lesion size|up to one year|Based on Simons optimal design for phase II trials, 25 evaluable patients were to be included and treated.||Participants|||Number
774109|NCT00744692|Secondary|To Describe the Pace of Platelet Recovery|Platelet engraftment was defined as the first day of platelet counts more than 50,000/uL for 7 consecutive days without transfusions|180 days post transplant|||days||Full Range|Median
774110|NCT00744692|Secondary|To Evaluate the Incidence of Late Graft Failures at 2 Years Post-transplant||2 years post transplant|Of the 22 patients at baseline, 5 patients died early before a year; and 2 additional patients had early graft failure. Thus 7 patients were not available for analysis of this 2 year late graft failure endpoint.||participants|||Number
774111|NCT00744692|Secondary|To Evaluate Long-term Complications, Such as Sterility, Endocrinopathy, and Growth Failure||at least 2 years post transplant|Of the 22 patients at baseline, 5 patients died early before a year; and 2 additional patients had early graft failure. Thus 7 patients were not available for analysis of this 2 year late effects endpoint.||percentage of patients|||Number
774112|NCT00744692|Secondary|To Describe the Incidence of Grade 3-4 Organ Toxicity||2 years post transplant|||participants|||Number
774113|NCT00744692|Secondary|To Describe Incidence of Acute Graft Versus Host Disease (GVHD) (II - IV)|To describe incidence of acute Graft Versus Host Disease (GVHD) (II - IV) : measured by cumulative incidence analysis|100 days post transplant|||percentage of participants||95% Confidence Interval|Number
774114|NCT00744692|Secondary|To Determine the Overall Survival at day180 Post-transplant|To determine the overall survival at day180 post-transplant: determined by Kaplan Meier survival analysis|180 days|||percentage of participants||95% Confidence Interval|Number
774115|NCT00744692|Secondary|To Evaluate the Pace of Immune Reconstitution.|Immune reconstitution after RIC in UCBT was described. CD4 count is a standard measure of immune reconstitution and is described here. Additional data is available upon request.|1 year post transplant|Of the 22 patients at baseline, 5 patients died early before a year; and 2 additional patients had early graft failure. Thus 7 patients were not available for analysis of Immune reconstitution endpoint. CD4 count is reported here.||cells/uL||Full Range|Median
774116|NCT00744692|Secondary|To Describe the Pace of Neutrophil Recovery|Neutrophil recovery was defined as the first day of an absolute neutrophil count (ANC) more than 500/uL for 3 consecutive days not secondary to granulocyte infusions|42 days post transplant|||days||Full Range|Median
774117|NCT00744692|Primary|Determine the Feasibility of Attaining Acceptable Rates of Donor Cell Engraftment (>25% Donor Cells at 180 Days) Following RIC Regimens in Children < 21 Years Receiving UCBT for Non-malignant Disorders.|Determine the feasibility of attaining acceptable rates of donor cell engraftment (>25% donor cells at 180 days) following reduced intensity conditioning regimens in children < 21 years receiving cord blood transplant for non-malignant disorders.|180 days post transplant|Of the 22 patients enrolled, 18 patients were alive at 180 days, the time-point for primary end point||% of participants|||Number
774118|NCT00744757|Secondary|Quality of Life Assessment|The quality of life was assessed by the questionnaire QLQ C-30 designed by European Organization for the Research and Treatment of Cancer (EORTC). EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer participants. Most questions used 4-point scale (1=Not at All' to 4=Very Much') and 2 questions: Q29 on overall health and Q30 on overall quality of life uses 7-point scale ranging from 1=Very Poor to 7=Excellent. Higher score indicates better quality of life.|Day 1 of Cycle 1 and Cycle 8 (each cycle of 28 days)|ITT population was defined as all participants who had received at least 1 dose of study medication.||Unit on a scale||Standard Deviation|Mean
774119|NCT00744757|Secondary|Number of Events Which Led to Hospitalization|The events (reasons) for hospitalizations such as infection, transfusion, acute choleycystitis, allergic transfusion reaction, dyspnoea with right pleural effusion, febrile neutropenia, fever, for decitabine, Myelodysplastic Syndrome (MDS) hematuria, paronychia, pneumonia, heart failure, peri-anal abscess (PAA), pancytopenia,fluctuated neutropenia fever, right dorsal foot cellulitis, Right lower (Rt.Lw) lung pneumonia with impending respiratory (resp) failure, Serious adverse event (SAE)+schedule hospitalization for decitabine, septic shock and not available were reported.|Start of treatment until disease progression or death or up to Cycle 8, each cycle of 28 days|ITT population was defined as all participants who had received at least 1 dose of study medication.||Events|||Number
774120|NCT00744757|Secondary|Duration for Hospitalization|Duration of hospitalization was calculated for each participant, using the sum of all hospital days by subtracting the date of discharge from the date of admission.|Cycle 1 up to Cycle 8, each cycle of 28 days.|ITT population was defined as all participants who had received at least one dose of treatment. Here ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.||Days||Standard Deviation|Mean
774121|NCT00744757|Secondary|Percentage of Participants With Transfusion Independency|Transfusion independent participants were calculated from all the participants who required transfusion in the duration of 8 weeks before first dose until disease progression or death or up to 736 days. Transfusion independence was defined as lack of requirement for transfusions for at least 8 weeks.|8 weeks before first dose and 736 days of treatment|ITT population was defined as all participants who had received at least 1 dose of study medication.||percentage of participants|||Number
774122|NCT00744757|Secondary|Percentage of Participants With Transfusion Dependency|Transfusion requirements for both red blood cells as well as platelets were recorded for each participant.|8 weeks before first dose until disease progression or death (whichever occur first) or up to 736 days|ITT population was defined as all participants who had received at least 1 dose of study medication.||Percentage of participants|||Number
774123|NCT00744757|Secondary|Overall Survival|Overall survival was defined as the time from the date of treatment start until death (whatever the cause). It was calculated from Kaplan-Meier estimates. Participants still alive were censored at the moment of last visit or contact.|Start of treatment until disease progression or death (whichever occur first) or up to 736 days|ITT population was defined as all participants who had received at least 1 dose of study medication.||Months||Full Range|Median
774124|NCT00744757|Secondary|Time to Acute Myeloid Leukemia (AML) Progression or Death|Time to AML is defined as greater than 30 percent of blasts in bone marrow or the time to death was calculated from the date of treatment start until disease progression to AML or until death, which ever occurred first. Participants who were still alive and did not progress to AML were censored at the moment of last visit.|Start of treatment until disease progression or death (whichever occur first) or up to 736 days|ITT population was defined as all participants who had received at least 1 dose of study medication.||Months||Full Range|Median
774125|NCT00744757|Secondary|Percentage of Participants With Cytogenetic Response|Cytogenetic responses was assessed as per IWG 2006 criteria which define complete response as disappearance of the chromosomal abnormality without appearance of new ones and partial response as at least 50 percent reduction of the chromosomal abnormality.|Day 1 of Cycle 2, 4, 6, 8; each Cycle of 28 days and End of treatment (30-42 days after Cycle 8 or early withdrawal)|ITT population was defined as all participants who had received at least one dose of treatment. Here 'N' specifies those participants who were evaluated for this outcome measure and ‘n’ specifies those participants who were evaluated at given time point.||Percentage of participants|||Number
774126|NCT00744757|Secondary|Percentage of Participants With Hematologic Treatment Response|Hematologic treatment response was assessed as per IWG 2006 criteria. This is measured in erythroid(HI-E), platelet(HI-P) and neutrophil(HI-N) lineages. HI-E response(pre-treatment<11 gram per deciliter [g/dl]):hemoglobin increase by>=1.5 g/dl and relevant reduction in RBC transfusions by 4 RBC transfusions/8week. HI-P response (pre-treatment<100*109/l):absolute increase of >=30*10^9/l for participants starting with>20*10^9/l and increase from <20*10^9/l to>20*10^9/l and by at least 100%. HI-N response (pre-treatment<1.0*10^9/l): at least 100% increase and an absolute increase >0.5*10^9/l.|Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7 and 8, each Cycle of 28 days and End of treatment (30-42 days after Cycle 8 or early withdrawal)|Intent-to-treat (ITT) population was defined as all participants who had received at least one dose of treatment. Here ‘N’ specifies those participants who were evaluable for this outcome measure and ‘n’ specifies those participants who were evaluable for this outcome measure at given time point.||Percentage of participants|||Number
774127|NCT00744757|Primary|Percentage of Participants With Response|Percentage of participants with response: complete response (CR) or partial response (PR) according to International Working Group (IWG) 2006 criteria was evaluated. CR in bone marrow is defined as<=to 5% myeloblasts with normal maturation of all cell lines and persistent dysplasia was noted in peripheral blood hemoglobin >=11 gram (g) per deciliter (dl), platelets >=100*10^9 liter (l), neutrophils >=1.0*10^9 l, Blasts 0%. Partial response is defined as all CR criteria if abnormal before treatment except: bone marrow blasts decreased by >=50% over pre-treatment but still >=5%.|Day 1 of Cycle 2, 4, 6, 8; each Cycle of 28 days and End of treatment (30-42 days after Cycle 8 or early withdrawal)|The efficacy-evaluable (EE) population included all participants who received at least 2 cycles of treatment. Participants who died before receiving 2 complete cycles or were taken off study due to progressive disease were included. Here ‘N’ specifies those participants who were evaluable for this outcome measure.||Percentage of Participants|||Number
774128|NCT00744848|Secondary|Number of Participants With Adverse Events (AEs) Through Day 3 and Serious Adverse Events (SAEs) Through Day 30||through day 30||||||
774129|NCT00744848|Primary|Area Under the Curve (AUC) of the Numeric Rating Scale at Rest (NRS-R) Pain Intensity Scores|To assess pain intensity at rest (NRS-R), the subject was to assume a resting position that did not exacerbate his or her postoperative pain. The subject was to rest in this position for at least 5 minutes before responding to the following question, “On a scale of 0 to 10, where 0=no pain and 10=worst possible pain, how much pain are you having right now?”|through 96 hours|Note: 204 randomized subjects received study drug and were included in the analyses.||Units on a scale*hours||Standard Deviation|Mean
774130|NCT00744874|Secondary|Total Fluoroscopy Time|Total time that flouroscopy was used during the ablation procedure.|Post Ablation Procedure|||minutes||Standard Deviation|Mean
774131|NCT00744874|Secondary|Total Procedure Time|Measurement of total procedure time defined as “skin to skin” and left atrial dwell time (transseptal puncture to removal of all left atrial catheters)|End of Procedure|||minutes||Standard Deviation|Mean
774132|NCT00744874|Secondary|Measurement of the Cumulative RF Time for Pulmonary Vein(PV)Isolation of All Accessible Pulmonary Veins|Cumulative RF time was calculated by the difference between the start time of catheter ablations and the end time of the ablation|After Procedure|||minutes||Standard Deviation|Mean
774133|NCT00744874|Secondary|The Short Form 36 Question (SF-36) Health Survey Quality of Life Survey at 6 Months Compared to Baseline|The SF-36 is a short-form health survey of 36 questions that yields an 8-scale health profile as well as psychometrically-based physical and mental health summary measures. In order to assess improvement in self-perceived quality of life, subjects were asked to complete SF-36 questionnaires at baseline and at each follow-up visit. The results of the Physical Component and Mental Component scores from the two summary measures that aggregate sub-scales were then compared.The SF-36 subscales range from 0 (lowest) to 100 (highest). The subscales are averaged together for a total score between 0 to 100. A higher score represents a better outcome when compared to a lower score.|6 months|||units on a scale||Standard Deviation|Mean
774134|NCT00744874|Secondary|Atrial Fibrillation Symptom Severity Scores From Baseline to 6 Months|Subjects rated the severity of their AF-related symptoms at baseline and at each follow-up visit for the study. Symptoms that were assessed at each visit included the presence of palpitations, fatigue, shortness of breath, lightheadedness or dizziness, and/or lack of energy upon exertion or exercise. Each symptom was rated on a scale from 1 (no symptoms) to 5 (most severe). Total scores were obtained by adding up the rating for each symptom to obtain a range of results between 5 (asymptomatic) to 25 (severely symptomatic).|6 Months|||units on a scale||Standard Deviation|Mean
774135|NCT00744874|Primary|Chronic Safety|The Chronic Safety Endpoint was the proportion of subjects with serious procedure- and/or device-related events in the 7 day to 6 month follow-up period post-ablation. The relatedness of each event was assessed by the investigator at each site.|7 day post procedure to 6 months|The Chronic Safety Endpoint is the proportion of subjects with serious procedure and/or device-related events in the 7 day to 6 month follow-up period post-ablation. The relatedness of each event was assessed by the investigator at each site.||participants|||Number
774136|NCT00744874|Primary|Acute Safety|The Acute Safety Endpoint was defined as the proportion of subjects with Serious Adverse Events (SAEs) that were procedure- and/or device-related within 7 days after the ablation procedure. The relatedness of each event was assessed by the investigator at each site.|7 days post procedure|The proportion of subjects with one or more serious procedure and/or device related AEs occurring within 7 days of the ablation procedure. No acute events were related to the device.||participants|||Number
774137|NCT00744874|Primary|Chronic Effectiveness|The primary endpoint for chronic effectiveness was the evaluation of the proportion of subjects with treatment success computed at the 6 month visit. In order to be classified as a chronic success, all subjects were required to meet the following criteria: Absence of clinically significant AF (greater than 60 seconds) or left atrial tachycardia recorded on a 7-day Holter, absence of symptomatic AF after a 3 month blanking period, off all Class I and III AADs at 6 months.|6 months|The primary endpoint for chronic effectiveness was the evaluation of the proportion of subjects with treatment success computed at the 6 month visit.||participants|||Number
774138|NCT00744874|Primary|Number of Participants With Successful Pulmonary Vein Isolation|Acute effectiveness was defined as successful isolation of all pulmonary veins. Pulmonary vein isolation was documented by the absence of pulmonary vein potentials when assessed by electrogram tracings in sinus rhythm using the PVAC catheter.|6 months|Subjects that had successful pulmonary vein isolation.||participants|||Number
774139|NCT00744939|Secondary|Number of Participants With Adverse Events (AEs) Reported in Association With the Administration of Magnevist-per Protocol Set|Adverse events occurring within 1 day after administration of Magnevist or skin-related adverse events occurring during follow-up (FU) were recorded.|Up to 24 months following the administration of Magnevist|Per protocol set. Participants with mild and extended moderate renal impairment were excluded from the per protocol analysis.||Participants|||Number
774140|NCT00744939|Secondary|Number of Participants With Adverse Events (AEs) Reported in Association With the Administration of Magnevist-cohort Analysis and Per Protocol Set|Adverse events occurring within 1 day after administration of Magnevist or skin-related adverse events occurring during follow-up (FU) were recorded.|Up to 24 months following the administration of Magnevist|Per protocol set. Participants with mild and extended moderate renal impairment were excluded from the per protocol analysis.||Participants|||Number
774141|NCT00744939|Secondary|Number of Participants With Adverse Events (AEs) Reported in Association With the Administration of Magnevist-full Analysis Set|Adverse events occurring within 1 day after administration of Magnevist or skin-related adverse events occurring during follow-up (FU) were recorded.|Up to 24 months following the administration of Magnevist|Full analysis set||Participants|||Number
774142|NCT00744939|Secondary|Number of Participants With Adverse Events (AEs) Reported in Association With the Administration of Magnevist-cohort Analysis and Full Analysis Set|Adverse events occurring within 1 day after administration of Magnevist or skin-related adverse events occurring during follow-up (FU) were recorded.|Up to 24 months following the administration of Magnevist|Full analysis set.||Participants|||Number
774143|NCT00744939|Secondary|Total Number of Participants With Clinicopathological Correlation of ‘NSF’ or ‘Consistent With NSF’ and Subjects Without Biopsy Developing Clinical Signs Consistent With NSF-per Protocol Set|"Either clinical or histopathology score need at least 2 and the other at least 3 for diagnosis of NSF. Clinical score 2, 3 or 4 required more than 1 minor criterion, 1 major criterion or more than 1 major criterion respectively. Major criteria: patterned plaques, joint contractures, cobblestoning, marked induration/Peau d’orange (upper extremity or above knee); minor Criteria: puckering/linear banding, superficial (plaque/patch), dermal papules, scleral plaques (subject aged <45 yrs). Pathology score 2, 3 or 4 required 2, 3 or at least 4 histological criteria respectively. Histological criteria include Increased cellularity with few other inflammatory cells, CD34+ spindle ore epithelioid cells in a reticular or parallel arrangement with “tram-tracking, presence of fine collagen and ropey collagen surrounded by clefts, elastic fibers preserved and Septal involvement. A clinical score of 4 was suggestive of developing clinical signs consistent with NSF in subjects without biopsy."|Up to 24 months following the administration of Magnevist|Per Protocol Set. Participants with mild and extended moderate renal impairment were excluded from the per protocol analysis.||Participants|||Number
774144|NCT00744939|Secondary|Total Number of Participants With Clinicopathological Correlation of ‘NSF’ or ‘Consistent With NSF’ and Subjects Without Biopsy Developing Clinical Signs Consistent With NSF-cohort Analysis and Per Protocol Set|"Either clinical or histopathology score need at least 2 and the other at least 3 for diagnosis of NSF. Clinical score 2, 3 or 4 required more than 1 minor criterion, 1 major criterion or more than 1 major criterion respectively. Major criteria: patterned plaques, joint contractures, cobblestoning, marked induration/Peau d’orange (upper extremity or above knee); minor Criteria: puckering/linear banding, superficial (plaque/patch), dermal papules, scleral plaques (subject aged <45 yrs). Pathology score 2, 3 or 4 required 2, 3 or at least 4 histological criteria respectively. Histological criteria include Increased cellularity with few other inflammatory cells, CD34+ spindle or epithelioid cells in a reticular or parallel arrangement with “tram-tracking, presence of fine collagen and ropey collagen surrounded by clefts, elastic fibers preserved and Septal involvement. A clinical score of 4 was suggestive of developing clinical signs consistent with NSF in subjects without biopsy."|Up to 24 months following the administration of Magnevist|Per protocol set. Participants with mild and extended moderate renal impairment were excluded from the per protocol analysis.||Participants|||Number
774145|NCT00744939|Secondary|Total Number of Participants With Clinicopathological Correlation of ‘NSF’ or ‘Consistent With NSF’ and Subjects Without Biopsy Developing Clinical Signs Consistent With NSF-full Analysis Set|"Either clinical or histopathology score need at least 2 and the other at least 3 for diagnosis of NSF. Clinical score 2, 3 or 4 required more than 1 minor criterion, 1 major criterion or more than 1 major criterion respectively. Major criteria: patterned plaques, joint contractures, cobblestoning, marked induration/Peau d’orange (upper extremity or above knee); minor Criteria: puckering/linear banding, superficial (plaque/patch), dermal papules, scleral plaques (subject aged <45 yrs). Pathology score 2, 3 or 4 required 2, 3 or at least 4 histological criteria respectively. Histological criteria include Increased cellularity with few other inflammatory cells, CD34+ spindle or epithelioid cells in a reticular or parallel arrangement with “tram-tracking, presence of fine collagen and ropey collagen surrounded by clefts, elastic fibers preserved and Septal involvement. A clinical score of 4 was suggestive of developing clinical signs consistent with NSF in subjects without biopsy."|Up to 24 months following the administration of Magnevist|Full analysis set||Participants|||Number
774146|NCT00744939|Secondary|Total Number of Participants With Clinicopathological Correlation of ‘NSF’ or ‘Consistent With NSF’ and Subjects Without Biopsy Developing Clinical Signs Consistent With NSF-cohort Analysis and Full Analysis Set|"Either clinical or histopathology score need at least 2 and the other at least 3 for diagnosis of NSF. Clinical score 2, 3 or 4 required more than 1 minor criterion, 1 major criterion or more than 1 major criterion respectively. Major criteria: patterned plaques, joint contractures, cobblestoning, marked induration/Peau d’orange (upper extremity or above knee); minor Criteria: puckering/linear banding, superficial (plaque/patch), dermal papules, scleral plaques (subject aged <45 yrs). Pathology score 2, 3 or 4 required 2, 3 or at least 4 histological criteria respectively. Histological criteria include Increased cellularity with few other inflammatory cells, CD34+ spindle or epithelioid cells in a reticular or parallel arrangement with “tram-tracking, presence of fine collagen and ropey collagen surrounded by clefts, elastic fibers preserved and Septal involvement. A clinical score of 4 was suggestive of developing clinical signs consistent with NSF in subjects without biopsy."|Up to 24 months following the administration of Magnevist|Full analysis set||Participants|||Number
774147|NCT00744939|Primary|Number of Participants Who Developed NSF, Based on Diagnostically Specific Clinical and Histopathological Information-per Protocol Set|"Either clinical or histopathology score had to be at least 2 and the other at least 3 for diagnosis of NSF. Clinical score 2, 3 or 4 was derived from more than one minor criterion finding, one major criterion finding or more than one major criterion finding respectively. Major Criteria include patterned plaques, joint contractures, cobblestoning and marked induration/Peau d’orange (upper extremity or above knee); minor Criteria include puckering/linear banding, superficial (plaque/patch), dermal papules and scleral plaques (subject aged <45 years). Pathology score 2, 3 or 4 was derived from 2, 3 or at least 4 histological criteria findings respectively. Histological Criteria include increased cellularity (spindled and/or epithelioid) with few other inflammatory cells, CD34+ spindle or epithelioid cells in a reticular or parallel arrangement with “tram-tracking, presence of both fine collagen and ropey collagen surrounded by clefts, elastic fibers preserved and septal involvement."|Up to 24 months following the administration of Magnevist|Per Protocol Set. Participants with mild and extended moderate renal impairment were excluded from the per protocol analysis.||Participants|||Number
774148|NCT00744939|Primary|Number of Participants Who Developed NSF, Based on Diagnostically Specific Clinical and Histopathological Information-cohort Analysis and Per Protocol Set|"Either clinical or histopathology score had to be at least 2 and the other at least 3 for diagnosis of NSF. Clinical score 2, 3 or 4 was derived from more than one minor criterion finding, one major criterion finding or more than one major criterion finding respectively. Major Criteria include patterned plaques, joint contractures, cobblestoning and marked induration/Peau d’orange (upper extremity or above knee); minor Criteria include puckering/linear banding, superficial (plaque/patch), dermal papules and scleral plaques (subject aged <45 years). Pathology score 2, 3 or 4 was derived from 2, 3 or at least 4 histological criteria findings respectively. Histological Criteria include increased cellularity (spindled and/or epithelioid) with few other inflammatory cells, CD34+ spindle or epithelioid cells in a reticular or parallel arrangement with “tram-tracking, presence of both fine collagen and ropey collagen surrounded by clefts, elastic fibers preserved and septal involvement."|Up to 24 months following the administration of Magnevist|Per Protocol Set. Participants with mild and extended moderate renal impairment were excluded from the per protocol analysis.||Participants|||Number
774149|NCT00744939|Primary|Number of Participants Who Developed NSF, Based on Diagnostically Specific Clinical and Histopathological Information-full Analysis Set|"Either clinical or histopathology score had to be at least 2 and the other at least 3 for diagnosis of NSF. Clinical score 2, 3 or 4 was derived from more than one minor criterion finding, one major criterion finding or more than one major criterion finding respectively. Major Criteria include patterned plaques, joint contractures, cobblestoning and marked induration/Peau d’orange (upper extremity or above knee); minor Criteria include puckering/linear banding, superficial (plaque/patch), dermal papules and scleral plaques (subject aged <45 years). Pathology score 2, 3 or 4 was derived from 2, 3 or at least 4 histological criteria findings respectively. Histological Criteria include increased cellularity (spindled and/or epithelioid) with few other inflammatory cells, CD34+ spindle or epithelioid cells in a reticular or parallel arrangement with “tram-tracking, presence of both fine collagen and ropey collagen surrounded by clefts, elastic fibers preserved and septal involvement."|Up to 24 months following the administration of Magnevist|Full Analysis Set||Participants|||Number
774150|NCT00744939|Primary|Number of Participants Who Developed Nephrogenic Systemic Fibrosis (NSF), Based on Diagnostically Specific Clinical and Histopathological Information-cohort Analysis and Full Analysis Set|"Either clinical or histopathology score had to be at least 2 and the other at least 3 for diagnosis of NSF. Clinical score 2, 3 or 4 was derived from more than one minor criterion finding, one major criterion finding or more than one major criterion finding respectively. Major Criteria include patterned plaques, joint contractures, cobblestoning and marked induration/Peau d’orange (upper extremity or above knee); minor Criteria include puckering/linear banding, superficial (plaque/patch), dermal papules and scleral plaques (subject aged <45 years). Pathology score 2, 3 or 4 was derived from 2, 3 or at least 4 histological criteria findings respectively. Histological Criteria include increased cellularity (spindled and/or epithelioid) with few other inflammatory cells, CD34+ spindle or epithelioid cells in a reticular or parallel arrangement with “tram-tracking, presence of both fine collagen and ropey collagen surrounded by clefts, elastic fibers preserved and septal involvement."|Up to 24 months following the administration of Magnevist|Full Analysis Set||Participants|||Number
774151|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: Identification at Week 6|Assessment of the cognitive domain visual attention through a yes or no response to 30 trials within 5 minutes; score range: 0 to 3.69. Performance variable: speed of performance; average log10 transformed reaction time for correct responses. Reaction times longer than 5 seconds ( log10 [5000]) were excluded as reflecting responses that were abnormally slow.|Week 6|FAS; N = number of participants with a CogState score for Identification at Week 6.||log10 millisecond||Standard Error|Least Squares Mean
774152|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: Identification at Week 3|Assessment of the cognitive domain visual attention through a yes or no response to 30 trials within 5 minutes; score range: 0 to 3.69. Performance variable: speed of performance; average log10 transformed reaction time for correct responses. Reaction times longer than 5 seconds ( log10 [5000]) were excluded as reflecting responses that were abnormally slow.|Week 3|FAS; N = number of participants with a CogState score for Identification at Week 3.||log10 millisecond||Standard Error|Least Squares Mean
774153|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: Identification at Week 1|Assessment of the cognitive domain visual attention through a yes or no response to 30 trials within 5 minutes; score range: 0 to 3.69. Performance variable: speed of performance; average log10 transformed reaction time for correct responses. Reaction times longer than 5 seconds ( log10 [5000]) were excluded as reflecting responses that were abnormally slow.|Week 1|FAS; N = number of participants with a CogState score for Identification at Week 1.||log10 millisecond||Standard Error|Least Squares Mean
774154|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: Visual Learning at Week 6|Assessment of the cognitive domain episodic memory through yes or no responses within 5 minutes to 4 targets repeated among 6 distractors on 4 rounds (mild Alzheimer's disease [AD], or 3 targets repeated among 4 distractors on 4 rounds (moderate AD) ; score range: 0 to 1.57. Performance variable: accuracy of performance; arcsine transformation of proportion correct responses.|Week 6|FAS; N = number of participants with a CogState score for Visual Learning at Week 6.||arcsine proportion correct||Standard Error|Least Squares Mean
774155|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: Visual Learning at Week 3|Assessment of the cognitive domain episodic memory through yes or no responses within 5 minutes to 4 targets repeated among 6 distractors on 4 rounds (mild Alzheimer's disease [AD], or 3 targets repeated among 4 distractors on 4 rounds (moderate AD) ; score range: 0 to 1.57. Performance variable: accuracy of performance; arcsine transformation of proportion correct responses.|Week 3|FAS; N = number of participants with a CogState score for Visual Learning at Week 3.||arcsine proportion correct||Standard Error|Least Squares Mean
774156|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: Visual Learning at Week 1|Assessment of the cognitive domain episodic memory through yes or no responses within 5 minutes to 4 targets repeated among 6 distractors on 4 rounds (mild Alzheimer's disease [AD], or 3 targets repeated among 4 distractors on 4 rounds (moderate AD) ; score range: 0 to 1.57. Performance variable: accuracy of performance; arcsine transformation of proportion correct responses.|Week 1|FAS; N = number of participants with a CogState score for Visual Learning at Week 1.||arcsine proportion correct||Standard Error|Least Squares Mean
774157|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: One Back Working Memory at Week 6|Assessment of the cognitive domain working memory through yes or no responses to 30 trials within 5 minutes; score range: 0 to 1.57. Performance variable: accuracy of performance; arcsine transformation of proportion correct responses.|Week 6|FAS; N = number of participants with a CogState score for One Back Working Memory at Week 6.||arcsine proportion correct||Standard Error|Least Squares Mean
774158|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: One Back Working Memory at Week 3|Assessment of the cognitive domain working memory through yes or no responses to 30 trials within 5 minutes; score range: 0 to 1.57. Performance variable: accuracy of performance; arcsine transformation of proportion correct responses.|Week 3|FAS; N = number of participants with a CogState score for One Back Working Memory at Week 3.||arcsine proportion correct||Standard Error|Least Squares Mean
774159|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: One Back Working Memory at Week 1|Assessment of the cognitive domain working memory through yes or no responses to 30 trials within 5 minutes; score range: 0 to 1.57. Performance variable: accuracy of performance; arcsine transformation of proportion correct responses.|Week 1|FAS; N = number of participants with a CogState score for One Back Working Memory at Week 1.||arcsine proportion correct||Standard Error|Least Squares Mean
774160|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: Continuous Paired Associate Learning (CPAL) at Week 6|Assessment of the cognitive domain visual episodic memory (associate learning) through responses within 7 minutes to 4 targets x 4 rounds (mild AD) or 3 targets x 4 rounds (moderate AD); score range: 35 to 100. Performance variable: number of errors made in correctly placing each of the 4 patterns in their location four times.|Week 6|FAS; N = number of participants with a CogState score for Continuous Paired Associate Learning at Week 6.||errors||Standard Error|Least Squares Mean
774161|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: Continuous Paired Associate Learning (CPAL) at Week 3|Assessment of the cognitive domain visual episodic memory (associate learning) through responses within 7 minutes to 4 targets x 4 rounds (mild AD) or 3 targets x 4 rounds (moderate AD); score range: 35 to 100. Performance variable: number of errors made in correctly placing each of the 4 patterns in their location four times.|Week 3|FAS; N = number of participants with a CogState score for Continuous Paired Associate Learning at Week 3.||errors||Standard Error|Least Squares Mean
774162|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: Continuous Paired Associate Learning (CPAL) at Week 1|Assessment of the cognitive domain visual episodic memory (associate learning) through responses within 7 minutes to 4 targets x 4 rounds (mild AD) or 3 targets x 4 rounds (moderate AD); score range: 35 to 100. Performance variable: number of errors made in correctly placing each of the 4 patterns in their location four times.|Week 1|FAS; N = number of participants with a CogState score for Continuous Paired Associate Learning at Week 1.||errors||Standard Error|Least Squares Mean
774163|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: Detection at Week 6|Assessment of the cognitive domain psychomotor function through yes or no responses within 5 minutes to 30 trials; score range: 0 to 3.69. Performance variable: speed of performance; average of the log10 t transformed reaction time for correct responses. Reaction times longer than 5 seconds (log10 [5000]) were excluded as reflecting responses that were abnormally slow.|Week 6|FAS; N = number of participants with a CogState score for Detection at Week 6.||log10 millisecond||Standard Error|Least Squares Mean
774164|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: Detection at Week 3|Assessment of the cognitive domain psychomotor function through yes or no responses within 5 minutes to 30 trials; score range: 0 to 3.69. Performance variable: speed of performance; average of the log10 t transformed reaction time for correct responses. Reaction times longer than 5 seconds (log10 [5000]) were excluded as reflecting responses that were abnormally slow.|Week 3|FAS; N = number of participants with a CogState score for Detection at Week 3.||log10 millisecond||Standard Error|Least Squares Mean
787070|NCT00839956|Secondary|Survival for All Patients||Up to 5 years|||Participants|||Count of Participants
774165|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: Detection at Week 1|Assessment of the cognitive domain psychomotor function through yes or no responses within 5 minutes to 30 trials; score range: 0 to 3.69. Performance variable: speed of performance; average of the log10 t transformed reaction time for correct responses. Reaction times longer than 5 seconds (log10 [5000]) were excluded as reflecting responses that were abnormally slow.|Week 1|FAS; N = number of participants with a CogState score for Detection at Week 1.||log10 millisecond||Standard Error|Least Squares Mean
774166|NCT00744978|Secondary|Neuropsychiatric Inventory (NPI) Total Score at Week 6|Caregiver interview-based rating scale assessing 12 behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior, appetite/eating, and sleep. Each symptom score derived by frequency of symptoms * severity of symptoms (range 0-12). Total score = sum of symptom scores; range: 0-144 with higher score indicating greater behavioral disturbances.|Week 6|FAS. N = number of participants with a NPI total score at Week 6.||scores on scale||Standard Error|Least Squares Mean
774167|NCT00744978|Secondary|Neuropsychiatric Inventory (NPI) Total Score at Week 3|Caregiver interview-based rating scale assessing 12 behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior, appetite/eating, and sleep. Each symptom score derived by frequency of symptoms * severity of symptoms (range 0-12). Total score = sum of symptom scores; range: 0-144 with higher score indicating greater behavioral disturbances.|Week 3|FAS. N = number of participants with a NPI total score at Week 3.||scores on scale||Standard Error|Least Squares Mean
774168|NCT00744978|Secondary|Mean Clinical Global Impression - Improvement (CGI-I) Score at Week 6|CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Week 6|FAS; N = number of participants with a CGI-I score at Week 6.||units on a scale||Standard Error|Least Squares Mean
774169|NCT00744978|Secondary|Alzheimer's Disease Assessment Scale-Cognitive Subscale 70 (ADAS-Cog 70) at Week 6|11-item scale designed to assess the severity of cognitive impairments in AD subjects. Items include word recall, naming objects and fingers, following commands, constructional praxis, ideational praxis, orientation, word recognition, spoken language ability, comprehension of spoken language, word finding difficulty in spontaneous speech, and remembering test instructions. Total score range from 0-70 with 70 indicating worse cognition.|Week 6|FAS. N = number of participants with ADAS-Cog 70 results at Week 6.||units on scale||Standard Error|Least Squares Mean
774170|NCT00744978|Secondary|Alzheimer's Disease Assessment Scale-Cognitive Subscale 70 (ADAS-Cog 70) at Week 3|11-item scale designed to assess the severity of cognitive impairments in AD subjects. Items include word recall, naming objects and fingers, following commands, constructional praxis, ideational praxis, orientation, word recognition, spoken language ability, comprehension of spoken language, word finding difficulty in spontaneous speech, and remembering test instructions. Total score range from 0-70 with 70 indicating worse cognition.|Week 3|FAS. N = number of participants with ADAS-Cog 70 results at Week 3.||units on scale||Standard Error|Least Squares Mean
774171|NCT00744978|Secondary|Alzheimer's Disease Assessment Scale-Cognitive Subscale 75 (ADAS-Cog 75) at Week 3|12-item scale to assess severity of cognitive impairment in AD. Items include word recall, naming objects and fingers, following commands, constructional praxis, ideational praxis, orientation, word recognition, spoken language ability, comprehension of spoken language, word finding difficulty in spontaneous speech, remembering test instructions, and concentration/distractibility. Total score range from 0-75 with 75 indicating worse cognition.|Week 3|FAS; N = number of participants with ADAS-Cog 75 results at Week 3.||units on scale||Standard Error|Least Squares Mean
774172|NCT00744978|Primary|Alzheimer's Disease Assessment Scale-Cognitive Subscale 75 (ADAS-Cog 75) at Week 6|12-item scale to assess severity of cognitive impairment in AD. Items include word recall, naming objects and fingers, following commands, constructional praxis, ideational praxis, orientation, word recognition, spoken language ability, comprehension of spoken language, word finding difficulty in spontaneous speech, remembering test instructions, and concentration/distractibility. Total score range from 0-75 with 75 indicating worse cognition.|Week 6|Full analysis set (FAS): all participants who were randomized and took at least 1 dose of randomized study medication. N = number of participants with ADAS-Cog 75 results at Week 6.||units on scale||Standard Error|Least Squares Mean
774173|NCT00745030|Secondary|Study Terminated Due to Low Subject Recruitment and Enrollment.|Low subject recruitment and enrollment|||||||
774174|NCT00745030|Secondary|Changes in The Montreal Cognitive Assessment Scale (MoCA)||12 weeks||||||
774175|NCT00745030|Secondary|Changes in Mini-Mental State Exam (MMSE)||12 weeks||||||
774176|NCT00745030|Secondary|Changes in Physician Completed United Parkinson’s Disease Rating Scale (UPDRS)||12 weeks||||||
774177|NCT00745030|Secondary|Changes in Patient Completed PDQ-39 Scale(PD-specific Quality of Life Scale)||12 weeks||||||
774178|NCT00745030|Secondary|Changes in Patient Completed The Fatigue Severity Scale (FSS)||12 weeks||||||
774179|NCT00745030|Secondary|Changes in Pittsburgh Sleep Quality Index (PSQI) (Patient Completed)||12 weeks||||||
774180|NCT00745030|Secondary|Changes in Beck Depression Inventory (BDI)||12 weeks||||||
774181|NCT00745030|Secondary|Changes in Patient Completed Epworth Sleepiness Scale (ESS)||12 weeks||||||
774182|NCT00745030|Secondary|Changes in Patient Completed Parkinson's Disease Sleep Scale (PDSS)- the Only Validated PD Specific, Questionnaire-based, Sleep Evaluation Scale||12 weeks||||||
774183|NCT00745030|Secondary|Changes in RBD Structured Questionnaire (Completed by Patient and Bed Partner)||12 weeks||||||
774184|NCT00745030|Secondary|Changes in Clinician Global Impression Scale of Improvement (CGI-I)||10 weeks||||||
774185|NCT00745030|Secondary|Changes in Mean TST, LPS, WASO (Based on PSG)||8 weeks||||||
774186|NCT00745030|Secondary|Change in the Amount of Tonic Muscle Activity Based on the Results of the Baseline and Final Polysomnographic (PSG) Study||8 weeks||||||
774187|NCT00745030|Primary|Change in the Frequency of RBD Based on the Daily Sleep Diaries, Completed Daily for the Duration of the Study by the Study Subjects' Bed Partners/Caregivers|"Change in the frequency of RBD based on the daily sleep diaries, completed daily for the duration of the study by the study subjects' bed partners/caregivers.
Data will not be analyzed. The protocol is being terminated due to low subject enrollment and recruitment."|12 weeks|||Participants|||Number
774188|NCT00745095|Secondary|Polyp Detection|The number of polyps detected during colonoscopic procedures were recorded and compared to each bowel cleansing preparation.|Time of Study|||Number of polyps detected (numerical)||Standard Deviation|Mean
774189|NCT00745095|Primary|Quality of Bowel Preparation|The quality of bowel preparation was determined by using the Ottawa Scale for bowel Evacuation. The range of this score is from 0 (perfectly clean and dry colon) to 14 ( a colon filled with stool and liquid). The right, mid and rectosigmoid colon were independently rated from 0-4 and fluid quality of entire colon was recorded with an additional score of 0-2. The total Ottawa Score is calculated by the sum of the independent scores of all three sections of the colon plus the fluid content.|1-2 days following intervention|||units on a scale||Standard Deviation|Mean
774190|NCT00745251|Secondary|Percent Change in Weight From Baseline to Week 28||baseline to week 28|Intent-to-treat Last-observation-carried-forward (ITT-LOCF)||percent change||Standard Error|Least Squares Mean
774191|NCT00745251|Primary|Change in the Apnea/Hypopnea Index (AHI) Between Baseline and Week 28/Early Term.|AHI is calculated as the mean number of apnea or hypopnea episodes (each lasting a minimum of 10 second) observed per hour of sleep|between baseline and Week 28|Intent-to-treat Last-observation-carried-forward (ITT-LOCF)||events/hour||Standard Error|Least Squares Mean
774192|NCT00745290|Secondary|Number of Participants With Adverse Events Through 96 Hours and Serious Adverse Events Through 30 Days||through 30 days||||||
774193|NCT00745290|Primary|Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) With Activity (NRS-A) Pain Intensity Scores|The subject’s pain intensity was assessed with activity (NRS-A), while actively flexing the involved knee from the maximum extension point to the maximum flexion point possible. The subject responded to the following question, “On a scale of 0 to 10, where 0 = no pain and 10 = worst possible pain, how much pain did you have while bending your knee?”|through 72 hours post surgery|Note: 245 subjects were randomized and received study drug and were included in the analyses.||Units on a scale*hours||Standard Deviation|Mean
774194|NCT00745368|Primary|Female Genital Tract:Plasma Concentration Ratio|Units of raltegravir concentration for genital tract and plasma sample are ng/mL|8-10 hours after raltegravir dose|||ratio||Inter-Quartile Range|Median
774195|NCT00745368|Primary|Male Genital Tract:Plasma Concentration Ratio|Units of raltegravir concentration for genital tract and plasma sample are ng/mL|8-10 hours after raltegravir dose|||ratio||Inter-Quartile Range|Median
774196|NCT00745368|Primary|Female Time Since Last Dose|This measure describes the amount of time that expired between when the dose was administered and when the sample was taken|8-10 hours after raltegravir dose|||hours||Inter-Quartile Range|Median
774197|NCT00745368|Primary|Male Time Since Last Dose|This measure describes the amount of time that expired between when the dose was administered and when the sample was taken|8-10 hours after raltegravir dose|||hours||Inter-Quartile Range|Median
774198|NCT00745368|Primary|Female Paired Plasma Concentration|This sample was taken as close to the time of genital tract sample as possible|8-10 hours after raltegravir dose|||ng/mL||Inter-Quartile Range|Median
774199|NCT00745368|Primary|Male Paired Plasma Concentration|This sample was taken as close to the time of genital tract sample as possible|8-10 hours after raltegravir dose|||ng/mL||Inter-Quartile Range|Median
774200|NCT00745368|Primary|Raltegravir Female Genital Tract Concentration||8-10 hours after raltegravir dose|||ng/mL||Inter-Quartile Range|Median
774201|NCT00745368|Primary|Raltegravir Male Genital Tract Concentration||8-10 hours after raltegravir dose|||ng/mL||Inter-Quartile Range|Median
774202|NCT00745498|Secondary|Postoperative Resolution of Neovascularization||6 months||||||
774203|NCT00745498|Secondary|Visual Outcome|Best-corrected visual acuity (BCVA) at postoperative 6 months|6 months|||logMAR||Standard Deviation|Mean
774204|NCT00745498|Secondary|Initial Time of Vitreous Clearing (ITVC)|The interval in number of days for VH of grade 1 or more observed at postoperative day 1 to clear-up completely. VH of grade 1 was defined as mild vitreous hemorrhage with visible fundus details, but difficult to evaluate the retinal nerve fiber layer or small vessels.|6 months|||days||Standard Deviation|Mean
774205|NCT00745498|Primary|Recurrent VH Incidence (Early and Late)|"Recurrent VH was defined as a new episode of grade 1 or more VH occurring more than 1 week after surgery. Early recurrent VH was VH occurring <= 4 weeks and late recurrent VH was VH occurring >4 weeks after surgery."|6 months|With study power of 80%, significance level of 0.05, assumption that IVB injection will decrease postoperative VH incidence from 35% to 10%, a sample size of 40 patients for each group was calculated. The ITT approach was used for analysis.||Percentage of participants|||Number
774218|NCT00745901|Primary|Number of Participants With Breakthrough Bleeding/Spotting Cycle 3|Unscheduled bleeding is any bleeding during active pills except days 1–4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1–7 of the first cycle.|Cycle 3 (Day 57 to 77 for NGM/25mcg EE and day 57 to 80 for DRSP/20mcg EE)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 3.||Participants|||Number
774219|NCT00745901|Primary|Number of Participants With Breakthrough Bleeding/Spotting Cycle 2|Breakthrough bleeding/spotting is any bleeding or spotting during active pills excluding days contiguous with withdrawal bleeding or continual withdrawal bleeding.|Cycle 2 (Day 29 to 49 for NGM/25mcg EE and day 29 to 52 for DRSP/20mcg EE)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 2.||Participants|||Number
774220|NCT00745901|Primary|Number of Participants With Breakthrough Bleeding/Spotting Cycle 1|Breakthrough bleeding/spotting is any bleeding or spotting during active pills excluding days contiguous with withdrawal bleeding or continual withdrawal bleeding.|Cycle 1 (Day 8 to 21 for NGM/25mcg EE and day 8 to 24 for DRSP/20mcg EE)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.||Participants|||Number
774221|NCT00745901|Primary|Number of Participants With Unscheduled Bleeding Cycle 3|Unscheduled bleeding is any bleeding during active pills except days 1–4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1–7 of the first cycle.|Cycle 3 (Day 57 to 77 for NGM/25mcg EE and day 57 to 80 for DRSP/20mcg EE)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 3.||Participants|||Number
774222|NCT00745901|Primary|Number of Participants With Unscheduled Bleeding Cycle 2|Unscheduled bleeding is any bleeding during active pills except days 1–4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1–7 of the first cycle.|Cycle 2 (Day 29 to 49 for NGM/25mcg EE and day 29 to 52 for DRSP/20mcg EE)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 2.||Participants|||Number
774223|NCT00745901|Primary|Number of Participants With Unscheduled Bleeding Cycle 1|Unscheduled bleeding is any bleeding during active pills except days 1–4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1–7 of the first cycle.|Cycle 1 (Day 8 to 21 for NGM/25mcg EE and day 8 to 24 for DRSP/20mcg EE)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.||Participants|||Number
774224|NCT00745901|Primary|Overall Number of Days of Total Blood Loss|cycle control between treatment groups, overall. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity.|Cycle 1 to 3 (Day 8 to Day 84)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.||Days||Standard Deviation|Mean
774225|NCT00745901|Primary|Number of Days of Total Blood Loss – Cycle 3|cycle control between treatment groups, cycle 3. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity.|Cycle 3 (Day 57 to Day 84)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 3.||Days||Standard Deviation|Mean
774226|NCT00745901|Primary|Number of Days of Total Blood Loss – Cycle 2|cycle control between treatment groups, cycle 2. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity.|Cycle 2 (day 29 to Day 56)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 2.||Days||Standard Deviation|Mean
774227|NCT00745901|Primary|Number of Days of Total Blood Loss – Cycle 1|cycle control between treatment groups, cycle 1. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity.|Cycle 1 (Day 8 to Day 28)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.||Days||Standard Deviation|Mean
774228|NCT00745901|Primary|Overall Number of Days of Scheduled Blood Loss|summary of the overall number of days of scheduled blood loss. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Scheduled bleeding was defined as any bleeding that occurred while not taking active hormones, regardless of the duration of regimen.|Cycle 1 to Cycle 3 (Day 8 to Day 84)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.||Days||Standard Deviation|Mean
774229|NCT00745901|Primary|Number of Days of Scheduled Blood Loss – Cycle 3|cycle control between treatment groups, cycle 3. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Scheduled bleeding was defined as any bleeding that occurred while not taking active hormones, regardless of the duration of regimen.|Cycle 3 (Day 78 to 84 for NGM/25mcg EE and day 81 to 84 for DRSP/20mcg EE)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 3.||Days||Standard Deviation|Mean
774230|NCT00745901|Primary|Number of Days of Scheduled Blood Loss – Cycle 2|cycle control between treatment groups, cycle 2. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Scheduled bleeding was defined as any bleeding that occurred while not taking active hormones, regardless of the duration of regimen.|Cycle 2 (Day 50 to 60 for NGM/25mcg EE and day 53 to 60 for DRSP/20mcg EE)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 2.||Days||Standard Deviation|Mean
774815|NCT00751621|Secondary|Number of Infection Episodes|Total number of infections for the specified analysis population|Up to 42 months|The AT safety data set comprised all subjects treated with IgPro20 during any study period and was identical to the ITT data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available.||infection episodes|||Number
774231|NCT00745901|Primary|Number of Days of Scheduled Blood Loss - Cycle 1|cycle control between treatment groups, cycle 1. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Scheduled bleeding was defined as any bleeding that occurred while not taking active hormones, regardless of the duration of regimen.|Cycle 1 (Day 22 to 32 for NGM/25mcg EE and day 25 to 32 for DRSP/20mcg EE)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.||Days||Standard Deviation|Mean
774232|NCT00745901|Primary|Number of Participants With the Indicated Number of Unscheduled Blood Loss Episodes|Unscheduled blood loss episodes are bounded on both sides by at least 1 non- bleeding day.|Cycle 1 to Cycle 3 (Day 8 to Day 80)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.||Participants|||Number
774233|NCT00745901|Primary|Overall Number of Days of Unscheduled Blood Loss|cycle control between treatment groups, for three 28-day cycles. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Unscheduled bleeding is any bleeding during active pills except days 1–4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1–7 of the first cycle.|Cycle 1 to Cycle 3 (Day 8 to Day 80)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.||Days||Standard Deviation|Mean
774234|NCT00745901|Primary|Number of Days of Unscheduled Blood Loss - Cycle 3|Number of Days of Unscheduled Blood Loss - Cycle 3. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Unscheduled bleeding is any bleeding during active pills except days 1–4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1–7 of the first cycle.|Cycle 3 (Day 57 to 77 for NGM/25mcg EE and day 57 to 80 for DRSP/20mcg EE)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 3.||Days||Standard Deviation|Mean
774235|NCT00745901|Primary|Number of Days of Unscheduled Blood Loss - Cycle 2|cycle control between treatment groups, cycle 2. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Unscheduled bleeding is any bleeding during active pills except days 1–4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1–7 of the first cycle.|Cycle 2 (Day 29 to 49 for NGM/25mcg EE and day 29 to 52 for DRSP/20mcg EE)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 2.||Days||Standard Deviation|Mean
774236|NCT00745901|Secondary|Patient Satisfaction - Overall|patient satisfaction based on 5 questions during three 28-day cycles - Question 1 (Overall Satisfaction). On a scale of 1 to 5 where 1=Very satisfied and 5=Very dissatisfied.|Cycle 1 to Cycle 3|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.||Participants|||Number
774237|NCT00745901|Primary|Number of Days of Unscheduled Blood Loss - Cycle 1|cycle control between treatment groups, cycle 1. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Unscheduled bleeding is any bleeding during active pills except days 1–4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1–7 of the first cycle.|Cycle 1 (Day 8 to 21 for NGM/25mcg EE and day 8 to 24 for DRSP/20mcg EE)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.||Days||Standard Deviation|Mean
774238|NCT00745940|Secondary|Philadelphia Mindfulness Scale (Acceptance Subscale)|The Philadelphia Mindfulness Scale (PHLMS) is a measure of mindfulness to assess present-moment awareness and acceptance. The questionnaire comprises 20 questions rated on a five-point Likert scale with higher scores indicative of greater mindfulness. It comprises two subscales - Awareness and Acceptance. The range of scores on the Awareness subscale is 10 to 50 and the range on the Acceptance subscale is 10 to 50 with higher scores indicative a greater awareness and acceptance respectively.|Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.|||units on a scale||Standard Deviation|Mean
774239|NCT00745940|Secondary|Philadelphia Mindfulness Scale (Awareness Subscale)|The Philadelphia Mindfulness Scale (PHLMS) is a measure of mindfulness to assess present-moment awareness and acceptance. The questionnaire comprises 20 questions rated on a five-point Likert scale with higher scores indicative of greater mindfulness. It comprises two subscales - Awareness and Acceptance. The range of scores on the Awareness subscale is 10 to 50 and the range on the Acceptance subscale is 10 to 50 with higher scores indicative a greater awareness and acceptance respectively.|Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.|||units on a scale||Standard Deviation|Mean
774240|NCT00745940|Secondary|Symptom Checklist-90 Revised (Depression Subscale)|The Symptom Checklist-90 Revised (SCL-90-R) is a 90 item self-report questionnaire designed to measure nine primary symptom dimensions: somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, and psychoticism from the last two weeks from the current point in time. A five point Likert scale is used ranging from “Not at All” to “Extremely” with higher scores indicative of greater symptoms. There are 13 questions in the depression subscale with scores ranging between 0 and 52. To help with interpretation of all SCL-90-R sub-scales, we transformed this sub-scale total score back to a score between 0 to 4 with higher scores indicating greater depression symptoms.|Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.|||units on a scale||Standard Deviation|Mean
774251|NCT00746330|Secondary|Serial Forced Vital Capacity (FVC) Measurement (i.e. at 5, 30 Minutes and 1, 2, 4, 8 and 12 Hours Post-dose) Following Inhalation of a Single Dose of Study Medication to Evaluate the Onset and Duration of the Bronchodilatory Effect|All efficacy evaluations were based on spirometry assessments of lung function. FVC is the volume (liters) of air that can forcibly be blown out after full inspiration. At Visits 2, 3, 4 and 5, spirometry assessments were performed in the clinic at predose and again at 5 and 30 minutes and 1, 2, 4, 8 and 12 hours post-dose within ± 5 minutes of the scheduled time for the time points up to and including 60 minutes post-dose and then within ± 10 minutes for all subsequent time points. Spirometry equipment and performance of spirometric testing were in accordance with the ATS / ERS standards.|5, 30 Minutes and 1, 2, 4, 8 and 12 Hours Post-dose|Full Analysis Set||liters||95% Confidence Interval|Least Squares Mean
774241|NCT00745940|Primary|Beck Depression Inventory - II|The Beck Depression Inventory (BDI-II) is a 21-question multiple-choice self-report inventory, one of the most widely used instruments for measuring the severity of depression. It assesses the intensity of depression into 4 categories ranging from minimal (scores from 0-13) to severe (scores from 29-63) (79). Each item is a list of four statements arranged in increasing severity about a particular symptom of depression. The depression criteria are consistent with those of the Diagnostic and Statistical Manual of Mental Health Disorders—Fourth Edition (DSM-IV). The cognitive-affective factor includes items concerning sadness, past failure, loss of pleasure, guilty feelings, punishment feelings, self-dislike, self-criticalness, suicidal thoughts or wishes, crying, agitation, loss of interest, worthlessness, and irritability. The somatic factor is comprised of loss of energy, changes in sleeping pattern, changes in appetite, concentration difficulty, and tiredness or fatigue.|Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.|||units on a scale||Standard Deviation|Mean
774242|NCT00745940|Secondary|Patient Health Questionnaire (PHQ-9)|"The PHQ-9 is a self-administered questionnaire based on the PRIME-MD diagnostic instrument for common mental disorders. Each of the 9 DSM-IV criteria is scored on a four point Likert scale ranging from 0 (not at all) to 3 (nearly every day) with higher scores indicative of greater depression symptoms. Scores range from a low of 0 to a high of 27."|Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.|||units on a scale||Standard Deviation|Mean
774243|NCT00746096|Secondary|Difference in the VAS of Primary Dysmenorrhea (Baseline/Pretreatment-dnd of Treatment)|VAS stands for Visual Analogue Scale of pain. The scale was rated as a graphic rating scale. as a 100mm baseline from 0:No pain to 100:Worst possible pain.|16weeks|||units on a scale||Standard Deviation|Mean
774244|NCT00746096|Primary|Patient Response to Treatment for Primary Dysmenorrhea, as Evaluated by Difference of Total Dysmenorrhea Score (Baseline/Pretreatment-End of Treatment)|"The detail of dysmenorrhea score that was used in this study is the following. These subscales summed for a total dysmenorrhea score (minimum 0 to maximum 6). Pain score None 0 : None Mild 1 : There are some troubles for work Moderate 2 : Needing to rest in bed and/or affecting work Severe 3 : Morre than 1 day in bed and not possible to work
Drug score (during a menstrual period) None 0 : None Mild 1 : taking analgesics for 1 days Moderate 2 : taking analgesics for 2 days Severe 3 : taking analgesics more than 3 days"|16weeks|"Five patients in the IKH-01 group were excluded from efficacy analysis due to no available data for 3 patients and 2-4 administration days for 2 patients.
One patient in the placebo group was also excluded from efficacy analysis."||units on a scale||Standard Deviation|Mean
774245|NCT00746187|Primary|Marginal Bone Level Changes|Marginal bone adaptation was expressed as the distance from the implant reference point to the most coronal bone-to-implant contact on the mesial and distal side of the implant. Bone adaptation in millimeters at the 3-year follow-up visit were compared to values obtained at Implant placement (baseline). Positive value indicates bone gain and negative value bone loss.|3 years after implant placement (baseline)|Per protocol analysis presented and this includes 86 implants in 36 patients. At 3-year follow-up, 74 implants in 31 patients were still in the study and thus evaluable for the analysis.||millimeter|Participants|Standard Deviation|Mean
774246|NCT00746239|Secondary|Evaluate the Association of Improving Sleep Quality (With Ramelteon) on Improvement in Severity of Panic Disorder/Anxiety.||10 weeks||||||
774247|NCT00746239|Primary|Evaluate the Effects of Ramelteon on Sleep Quality in Panic Disorder Patients Who Are Also Treated With Escitalopram.||10 weeks||||||
774248|NCT00746330|Secondary|Urinary Excretion of Formoterol Following a Single Dose of Formoterol Fumarate Alone and in Combination With Mometasone Furoate Via the pMDI and Formoterol Fumarate Via the Dry Powder Inhaler (DPI)|Unchanged racemic formoterol in urine was assayed by LC-MS/MS. The lower limit of quantification (LLOQ) for urine was 0.0174 nmol/L expressed as free base. The amounts of unchanged formoterol excreted in urine from 0 to 3 hours (Ae0-3) and from 0 to 12 hours post-dose (Ae0-12) were calculated from the formoterol concentrations in urine and the urine volumes using non-compartmental methods.|0 to 3 hrs and 0-12 hrs|The pharmacokinetic population which was modified by the exclusion of dosing periods where formoterol was present at a concentration in excess of 5% of the Cmax.Five subjects were excluded due to various reasons.||nmol||90% Confidence Interval|Least Squares Mean
774249|NCT00746330|Secondary|Plasma Formoterol Concentrations (Pmol/L) Following a Single Dose of Formoterol Fumarate Alone and in Combination With Mometasone Furoate Via the pMDI and Formoterol Fumarate Via the Dry Powder Inhaler (DPI)|Unchanged racemic formoterol in plasma was assayed by LC-MS/MS. The lower limit of quantification (LLOQ) for plasma was 1.45 pmol/L. No non-compartmental PK analysis was performed.|5, 30 Minutes and 1, 2, 4, 8 and 12 Hours Post-dose|Because of the dosing periods where formoterol was present at concentrations greater than 5% of the Cmax data for 4 subjects was excluded. A dosing error resulted in the exclusion of 1 subject and 1 subject had all data excluded from PK evaluation due to the plasma drug concentrations in conflict with the recorded randomization.||pmol/L||Standard Deviation|Mean
774250|NCT00746330|Secondary|Serial Peak Expiratory Flow Rate (PEF) Measurement (i.e. at 5, 30 Minutes and 1, 2, 4, 8 and 12 Hours Post-dose) Following Inhalation of a Single Dose of Study Medication to Evaluate the Onset and Duration of the Bronchodilatory Effect|All efficacy evaluations were based on spirometry assessments of lung function. PEF is the greatest airflow rate achieved during forced exhalation with lungs fully inflated. At Visits 2, 3, 4 and 5, spirometry assessments were performed in the clinic at predose and again at 5 and 30 minutes and 1, 2, 4, 8 and 12 hours post-dose within ± 5 minutes of the scheduled time for the time points up to and including 60 minutes post-dose and then within ± 10 minutes for all subsequent time points. Spirometry equipment and performance of spirometric testing were in accordance with the ATS/ERS standards|5, 30 Minutes and 1, 2, 4, 8 and 12 Hours Post-dose|Full Analysis Set||liters||95% Confidence Interval|Least Squares Mean
774252|NCT00746330|Secondary|Serial FEV1 Measurement (i.e. at 5, 30 Minutes and 1, 2, 4, 8 and 12 Hours Post-dose) Following Inhalation of a Single Dose of Study Medication to Evaluate the Onset and Duration of the Bronchodilatory Effect|All efficacy evaluations were based on spirometry assessments of lung function. FEV1 is the maximum amount of air expired in one second. At Visits 2, 3, 4 and 5, spirometry assessments were performed in the clinic at predose and again at 5 and 30 minutes and 1, 2, 4, 8 and 12 hours post-dose within ± 5 minutes of the scheduled time for the time points up to and including 60 minutes post-dose and then within ± 10 minutes for all subsequent time points. Spirometry equipment and performance of spirometric testing were in accordance with the (ATS / ERS) standards.|5, 30 Minutes and 1, 2, 4, 8 and 12 Hours Post-dose|Full Analysis Set||liters||95% Confidence Interval|Least Squares Mean
774253|NCT00746330|Primary|The Standardized Forced Expiratory Volume in 1 Second (FEV1) Using Area Under the Curve (AUC) From 0 to 12 Hours (0-12h) Post-dose by Treatment|For FEV1 AUC(0-12h) the trapezoidal rule was applied using planned time measurements to calculate the AUC up to and including the last measurement recorded before intake of rescue medication. The AUC was standardized by dividing by the length of time for which measurements of FEV1 were included in the calculation of the AUC thus adjusting for subjects who were unable to complete the measurements during the 12-hour observation period and without inhaling rescue medication. The unit of the AUC was in L, being a weighted average of the acceptable FEV1 measurements recorded over 12 hours post dose|From 0 to 12 Hours (0-12h) post-dose, after each treatment administered (approximately 1 treatment a week for 4 weeks of treatment).|Full Analysis Set||liters||95% Confidence Interval|Least Squares Mean
774254|NCT00746356|Primary|Left Ventricular (LV) AutoCapture Effectiveness Endpoint - Difference Between the Automatic and Manual Capture Threshold Test|Left Ventricular AutoCapture is an automatic test that the device performs without any interaction by the physician and is one of the features being evaluated in the study. The test temporarily decreases the ventricular pacing voltage until it determines that the device is no longer capturing the ventricles. That value is reported to the physician when the device is read by the programmer. This endpoint looks at the absolute difference between this automated test and a manual test in which the physician decreases the ventricular pulse voltage and determines the ventricular threshold by viewing the EKG.|3 months post implant|Per protocol, the first 43 CRT-D participants who successfully completed both an automatic and manual threshold in the left ventricle were included in the analysis.||Volts||Standard Deviation|Mean
774255|NCT00746356|Primary|Right Ventricular (RV) AutoCapture Effectiveness Endpoint - Difference Between the Automatic and Manual Capture Threshold Test|Right Ventricular AutoCapture is an automatic test that the device performs without any interaction by the physician and is one of the features being evaluated in the study. The test temporarily decreases the ventricular pacing voltage until it determines that the device is no longer capturing the ventricles. That value is reported to the physician when the device is read by the programmer. This endpoint looks at the absolute difference between this automated test and a manual test in which the physician decreases the ventricular pulse voltage and determines the ventricular threshold by viewing the EKG.|3 months post implant|Per protocol, the first 43 CRT-D participants who successfully completed both an automatic and manual capture threshold in the right ventricle were included in this analysis.||Volts||Standard Deviation|Mean
774256|NCT00746356|Primary|Ventricular Autocapture Effectiveness Endpoint - Absolute Difference Between the Automatic and Manual Capture Threshold Test|Ventricular AutoCapture is an automatic test that the device performs without any interaction by the physician and is one of the features being evaluated in the study. The test temporarily decreases the ventricular pacing voltage until it determines that the device is no longer capturing the ventricles. That value is reported to the physician when the device is read by the programmer. This endpoint looks at the absolute difference between this automated test and a manual test in which the physician decreases the ventricular pulse voltage and determines the ventricular threshold by viewing the EKG.|3 months post implant|Per protocol, the first 38 participants with an ICD who successfully completed both an automatic and manual capture threshold test were included in this analysis.||Volts||Standard Deviation|Mean
774257|NCT00746356|Primary|Atrial AutoCapture (ACap) Confirm Effectiveness Endpoint - Absolute Difference Between the Automatic and Manual Capture Threshold Test|Atrial AutoCapture Confirm is an automatic test that the device performs without any interaction by the physician and is one of the features being evaluated in the study. The test temporarily decreases the atrial pacing voltage until it determines that the device is no longer capturing the atria. That value is reported to the physician when the device is read by the programmer. This endpoint looks at the absolute difference between this automated test and a manual test in which the physician decreases the atrial pulse voltage and determines the atrial threshold by viewing the EKG.|3 months post implant|Per protocol, the first 19 participants who successfully completed both an automatic and manual capture threshold test were included in this analysis.||Volts||Standard Deviation|Mean
774258|NCT00746356|Primary|Percentage of Participants Free of System-related Complications at 3-months Post Implant||3 months post implant|||Percentage of Participants|||Number
774259|NCT00746395|Secondary|Small Bowel Transit|Small bowel transit time|Duration of the test - 8 hours|Patients without transit to cecum were excluded||Minutes||Standard Error|Mean
774260|NCT00746395|Primary|Complete Small Bowel Transit|Percent of subjects with capsule passage through small bowel|8 hours|Placebo 95%, lubiprostone 75%||percentage of subjects with passage|||Number
774261|NCT00746421|Secondary|Brief Assessment of Cognition for Affective Disorders (BAC-A)|This is a series of neurocognitive tests and includes brief assessments of attention, motor speed, working memory, verbal memory, reasoning and problem solving, verbal fluency, affective interference, and emotion inhibition. The total BAC-A score is represented by a composite T-score which is dimensionless. This is computed by adding up the scores for each trial of a test domain (e.g. verbal memory) within the cognitive battery. Each test domain total is then inputted into a proprietary BAC-A calculator which determines the composite T-scores. A higher score indicates better performance. A study of 404 healthy adults demonstrated a mean composite score of 50 with a standard deviation of 10 (Keefe et al. Schizophrenia Bulletin. 2008; 102: 108-115).|6 weeks|The statistical analysis was planned as Intention to treat with LOCF as the endpoint variable. We initially aimed to enroll 50 patients per group but because the study was terminated early, with a total of only 32 subjects. These numbers are too small to have a meaningful statistical outcome and so this between group comparison was not performed.||units on a scale (composite t-score)||Standard Deviation|Mean
774262|NCT00746421|Primary|The Continuous Performance Test-Identical Pairs Version|The Continuous Performance Test, Identical Pairs version (CPT-IP) is a cognitive test that requires a subject to respond whenever two identical stimuli appear in a row within a sequence of 150 rapidly flashed trials. The outcome is measured as d' (detection signal) and is dimensionless. Among healthy adult men and women, d' scores ranged from 3.07-4.57 (Chen et al. Schizophrenia Bulletin, 1998; 24(1):163-174). The higher the value the better the performance. The d' is calculated by averaging the d' scores from three trials.|6 weeks|The statistical analysis was planned as Intention to treat with LOCF as the endpoint variable. We initially aimed to enroll 50 patients per group but because the study was terminated early, with a total of only 32 subjects. These numbers are too small to have a meaningful statistical outcome and so this between group comparison was not performed.||units on a scale||Standard Deviation|Mean
774263|NCT00746512|Secondary|Disease Activity Score 28 (DAS28) (C-reactive Protein [CRP])|"The DAS28(CRP) is a measure of disease activity with components which include the tender joint count (TJC) & swollen joint count (SJC) (each out of 28 joints counted), a Global Health (GH) index (100 mm visual analog scale [VAS]), and the CRP (in mg/L measured from lab test). The scoring formula was:
DAS28(CRP) = 0.56*SQR(TJC28) + 0.28*SQR(SJC28) + 0.36*ln(CRP+1) + 0.014*GH(VAS) + 0.96.
Where SQR is square root and ln is natural log.
The formula produces a score from 0 to 10: >5.1 means high disease activity; <3.2 means low disease activity, <2.6 is generally considered remission."|Baseline and Day 14|||score on scale||Standard Deviation|Mean
774264|NCT00746512|Primary|Synovial Blood Flow|Synovial Blood Flow was measured as the 2-dimensional quantitative Transverse Power Doppler Area summed over each of the 10 metacarpophalangeal joints (10MCP 2D Trans PDA). The PDA is a count of the number of pixels with power Doppler signal, uncorrected by pixel intensity, within an expert drawn region of interest encompassing the synovium and excluding digital vessels in a standardized 2D transverse image of the joint. A higher pixel count relates to greater synovial blood flow. A decrease in pixel count relates to a reduction in synovial blood flow.|Baseline and Day 14|||pixel count||Standard Deviation|Mean
774265|NCT00746551|Secondary|Haemoglobin Level||3 weeks after intervention|||g/dL||Standard Deviation|Mean
774266|NCT00746551|Primary|Serum Ferritin Level||3 weeks after intervention|||µg/dL||Standard Deviation|Mean
774267|NCT00746564|Other Pre-specified|Inappropriateness of Automatically Triggered Recordings – Phase II|The proportion of automatically triggered recordings that were inappropriate (i.e. noise triggered)was calculated and reported using a GEE model for binomial outcomes to account for multiple recordings per patient.|6 weeks|All patients implanted with the SJM Confirm device in participating in Phase II. Total patients 36: (19 rollovers from Phase I enrollments)+(25 Phase II enrollments)-(1 withdrawal)-(7 subjects with no automatically triggered recordings). Total recordings obtained: 958||percentage of inappropriate recordings|Participants|95% Confidence Interval|Number
774268|NCT00746564|Other Pre-specified|Inappropriateness of Automatically Triggered Recordings – Phase I|The proportion of automatically triggered recordings that were inappropriate (i.e. noise triggered)was calculated and reported using a generalized estimating equation (GEE) model for binomial outcomes to account for multiple recordings per patient.|6 weeks|50 patients implanted with the SJM Confirm device in Phase I. Total patients 47; 50-(1 withdrawal)-(2 patients whose recordings were lost due to programming changes).||percentage of inappropriate recordings|Participants|95% Confidence Interval|Number
774269|NCT00746564|Other Pre-specified|Interpretability of Automatically Triggered/Symptom Driven Recordings|The proportion of recording time during which the device recording was interpretable for each automatically triggered/symptom driven recording and for each subject.|6 weeks|50 patients implanted with the SJM Confirm device in Phase I. Total patients 47; 50-(1 withdrawal)-(2 patients whose recordings were lost due to programming changes). Total analyzable recordings 2804.||percentage of interpretable recordings|Participants|95% Confidence Interval|Number
774270|NCT00746564|Other Pre-specified|Interpretability of Weekly Subject Activator Recordings|The proportion of recording time during which the device recording was interpretable was calculated for each weekly Patient Activator recording and for each subject. A random effects model was fitted to the data.|6 weeks|50 patients implanted with the SJM Confirm device in Phase I. Total patients 30; 50-(1 withdrawal)-(19 patients who did not initiate recordings). Total analyzable recordings 58.||percentage of interpretable recordings|Participants|95% Confidence Interval|Number
774271|NCT00746564|Primary|Positive Predictive Value (PPV) During Hand to Hand/Shoulder Maneuvers|The positive predictive value (PPV) for the in-clinic recording was was calculated for each recording and for each subject.|6 weeks|50 patients implanted with the SJM Confirm device in Phase I. Total patients 48; 50-(1 withdrawal)-(1 patient recording lacking surface ECG channel). Total analyzable recordings 92: 96 obtained-(4 recordings with zero visible R waves)||percentage of recordings|Participants|95% Confidence Interval|Number
774272|NCT00746564|Primary|Positive Predictive Value (PPV) for In-Clinic Recordings During Treadmill Stress Test|The positive predictive value (PPV) for the in-clinic recording was calculated for each recording and for each subject.|6 weeks|50 patients implanted with the SJM Confirm device in Phase I. Total patients 45; 50-(1 withdrawal)-(1 patient recording lacking surface ECG channel)-(2 patients where no recording was obtained). Total analyzable recordings 45: 46 obtained-(1 recording with zero visible R waves).||percentage of recordings|Participants|95% Confidence Interval|Number
774273|NCT00746564|Primary|Positive Predictive Value (PPV) for In-Clinic Recordings at Rest|The positive predictive value (PPV) for the in-clinic recording was calculated for each recording and for each subject.|6 weeks|50 patients implanted with the SJM Confirm device in Phase I. Total patients 48; 50-(1 withdrawal)-(1 patient with no recording obtained). Total analyzable recordings 89.||percentage of recordings|Participants|95% Confidence Interval|Number
774274|NCT00746564|Primary|Sensitivity for R Waves During In-Clinic Recordings During Hand to Hand/Shoulder Maneuvers|The sensitivity for R waves during the in-clinic recordings was was calculated for each recording and for each subject.|6 weeks|50 patients implanted with the SJM Confirm device in Phase I. Total patients 48; 50-(1 withdrawal)-(1 patient recording lacking surface ECG channel). Total analyzable recordings 82; 96 obtained-(14 recordings with zero visible R waves)=82 recordings||percentage of recordings|Participants|95% Confidence Interval|Number
774275|NCT00746564|Primary|Sensitivity for R Waves During In-Clinic Recordings During Treadmill Exercise|The sensitivity for R waves during the in-clinic recordings was was calculated for each recording and for each subject.|6 weeks|50 patients implanted with the SJM Confirm device in Phase I. Total patients 46; 50-(1 withdrawal)-(1 patient's recording lacking surface ECG channel)-(2 no recording obtained). Total analyzable recordings =39; 46 obtained-(7 with zero visible R waves).||percentage of recordings|Participants|95% Confidence Interval|Number
774276|NCT00746564|Primary|Sensitivity for R Waves During In-Clinic Recordings at Rest|The sensitivity was calculated for each recording and for each subject.|6 weeks|50 patients implanted with the SJM Confirm device in Phase I were included in this analysis. Total patients 48; 50-(1 withdrawal)-(1 patient with recording lacking the surface channel). Total analyzable recordings 88; 89-(1 recording lacking visible R waves).||percentage of recordings|Participants|95% Confidence Interval|Number
774277|NCT00746590|Secondary|Changes in Laboratory Measurements||Baseline and every 3 weeks until progression||||||
774278|NCT00746590|Secondary|Adverse Events||Until progression||||||
774279|NCT00746590|Secondary|Changes in Alpha Fetoprotein||Baseline, every 3 weeks until progression||||||
774284|NCT00746668|Primary|Sentence Reading|To assess reading performance, after each training module (1-3), two lines of text were presented at the center of the monitor. Each subject was seated with his or her forehead on a head rest at a viewing distance of 40cm. The subject read each sentence aloud and indicated whether it made sense by responding true or false. Reading speed was calculated using an algorithm similar to that used for the MNRead test. The number of words read correctly was divided by the time required to read the sentence to yield a measure of reading speed in words per minute (wpm). Sentences were displayed at sizes of 0.1, 0.2, 0.3, 0.4, 0.5, and 0.6 log units above the subject's letter acuity threshold. Five sentences were presented at each font size. We used 105 different sentences so that no sentence was repeated for any subject. Average speed of reading (log wpm) was plotted as a function of font size (logMAR).|Pre-training, 6 weeks, 12 weeks, 18 weeks|Intent to Treat||Words per Minute (wpm)||Standard Deviation|Mean
774285|NCT00746694|Primary|Number of Participants That Received Curative Treatment and/or Prophylaxis Treatment for PPE|The number of participants who were treated with Caelyx, and who received either prophylactic treatment alone, or curative treatment alone, or both prophylactic and curative treatment for PPE.|Participants will do a single visit, but cases will be collected during a period of 12 months.|||Participants|||Number
774286|NCT00746694|Primary|Number of Participants Who Received Concomitant Treatment Strategies to Manage Palmar-Plantar Erythrodysesthesia (PPE)|"Participants treated with Caelyx who developed PPE and the categories of specific treatment strategies that were prescribed to manage the symptoms of PPE.
Participants counted under the strategies: Keep Skin Hydrated; Avoid Sweating and Physical Activity; Avoid Tight-Fitting Clothing; Local Cooling of Hands and Feet; were those who either always or sometimes followed it."|Participants will do a single visit, but cases will be collected during a period of 12 months.|||Participants|||Number
774287|NCT00746733|Primary|T 1/2 of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC|Total amphetamine is the d- and l-amphetamines.|0 through 96 hours after dosing|PK population||h||Standard Deviation|Mean
774288|NCT00746733|Primary|AUC of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC|Total amphetamine is the d- and l-amphetamines.|0 through 96 hours after dosing|PK population||ng.h/ml||Standard Deviation|Mean
774289|NCT00746733|Primary|Tmax of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC|Total amphetamine is the d- and l-amphetamines.|0 through 96 hours after dosing|PK population||h||Standard Deviation|Mean
774290|NCT00746733|Primary|Cmax of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC|Total amphetamine is the d- and l-amphetamines.|0 through 96 hours after dosing|PK population||ng/ml||Standard Deviation|Mean
774291|NCT00746733|Primary|T 1/2 of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC|l-Amphetamine is an isomer of Adderall XR and is an active form that is responsible for the drug's therapeutic activity.|0 through 96 hours after dosing|PK population||h||Standard Deviation|Mean
774292|NCT00746733|Primary|AUC of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC||0 through 96 hours after dosing|PK population||ng.h/ml||Standard Deviation|Mean
774293|NCT00746733|Primary|Tmax of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC|l-Amphetamine is an isomer of Adderall XR and is an active form that is responsible for the drug's therapeutic activity.|0 through 96 hours after dosing|PK population||h||Standard Deviation|Mean
774294|NCT00746733|Primary|Cmax of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC|l-Amphetamine is an isomer of Adderall XR and is an active form that is responsible for the drug's therapeutic activity.|0 through 96 hours after dosing|PK population||ng/ml||Standard Deviation|Mean
774295|NCT00746733|Secondary|Electrocardiogram Results (QTcF Interval) for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC|QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate(e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.|Pre-dose, 2 and 8 hours after dosing|Safety population||msec||Standard Deviation|Mean
774296|NCT00746733|Secondary|Pulse Rate for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC||Pre-dose and 1, 2, 4, 8, 12, 24, 48, 72 and 96 hours after dosing|Safety population||bpm||Standard Deviation|Mean
774297|NCT00746733|Secondary|Diastolic Blood Pressure for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC||Pre-dose and 1, 2, 4, 8, 12, 24, 48, 72 and 96 hours after dosing|Safety population||mmHg||Standard Deviation|Mean
774298|NCT00746733|Primary|Terminal Half-life (T 1/2) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC|d-Amphetamine is an isomer of Vyvanse and Adderall XR and is an active form that is responsible for the drug's therapeutic activity.|0 through 96 hours after dosing|PK population||h||Standard Deviation|Mean
774299|NCT00746733|Primary|Area Under the Steady-state Plasma Concentration-time Curve (AUC) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC|d-Amphetamine is an isomer of Vyvanse and Adderall XR and is an active form that is responsible for the drug's therapeutic activity.|0 through 96 hours after dosing|PK population||ng.h/ml||Standard Deviation|Mean
774300|NCT00746733|Primary|Time of Maximum Plasma Concentration (Tmax) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC|d-Amphetamine is an isomer of Vyvanse and Adderall XR and is an active form that is responsible for the drug's therapeutic activity.|0 through 96 hours after dosing|PK population||h||Standard Deviation|Mean
774301|NCT00746733|Secondary|Systolic Blood Pressure for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC||Pre-dose and 1, 2, 4, 8, 12, 24, 48, 72 and 96 hours after dosing|Safety population defined as subjects who take at least one dose of investigational medicinal product and have at least one post-dose safety assessment.||mmHg||Standard Deviation|Mean
774302|NCT00746733|Secondary|DRQ-S, Question 3, for Vyvanse and Adderall XR in Combination With Prilosec OTC|Question 3: Do you dislike the drug effect you are feeling now? Questions are rated on a 29-point scale from 1 (not at all) to 29 (an awful lot). The higher the score the stronger the subjective experience. This is a subjective measure of a drug's effect that has been used to assess the abuse potential of drugs.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12 and 24 hours after dosing|PD population||units on a scale||Standard Deviation|Mean
775854|NCT00754065|Secondary|Number of Spotting-only Episodes in Reference Period 4|Reference Period 4 is defined as Day 271 to Day 360 during study treatment.|From Day 271 to Day 360|All participants in FAS with assessment for this outcome measure||Episodes||Standard Deviation|Mean
774303|NCT00746733|Secondary|DRQ-S, Question 1, for Vyvanse and Adderall XR in Combination With Prilosec OTC|Question 1: How much do you feel the drug now? Questions are rated on a 29-point scale from 1 (not at all) to 29 (an awful lot). The higher the score the stronger the subjective experience. This is a subjective measure of a drug's effect that has been used to assess the abuse potential of drugs.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12 and 24 hours after dosing|PD population||units on a scale||Standard Deviation|Mean
774304|NCT00746733|Secondary|Drug Rating Questionnaire-Subject (DRQ-S), Question 2, for Vyvanse and Adderall XR in Combination With Prilosec OTC.|Question 2: How much do you like the effects you are feeling now? Questions are rated on a 29-point scale from 1 (not at all) to 29 (an awful lot). The higher the score the stronger the subjective experience. This is a subjective measure of a drug's effect that has been used to assess the abuse potential of drugs.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12 and 24 hours after dosing|Pharmacodynamic (PD) population defined as all subjects who have evaluable DRQ-S values reported.||units on a scale||Standard Deviation|Mean
774305|NCT00746733|Primary|Maximum Plasma Concentration (Cmax) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC|d-Amphetamine is an isomer of Vyvanse and Adderall XR and is an active form that is responsible for the drug's therapeutic activity.|0 through 96 hours after dosing|Pharmacokinetic (PK) population defined as all subjects who have evaluable concentration-time profiles.||ng/ml||Standard Deviation|Mean
774306|NCT00746785|Primary|Drinks Per Drinking Day|"Drinks are measured as the number of standard alcoholic beverages consumed each day, assessed in varying lengths of time (i.e., 2 weeks, 4 weeks, 6 weeks, etc.). A standard alcoholic beverage is equivalent to: 1, 12 oz. regular beer; 1, 5 oz. glass of wine; 1, mixed drink with one1.5 oz shot; or 1, 1.5 oz shot. A drinking day is measured as any day of the week in which an alcoholic beverage is consumed. Data for drinks per drinking day is gathered using the Time Line Follow Back method in which participants are asked to recall their alcohol consumption day by day for a pre-defined set of time."|up to 36 weeks|||Drinks per drinking day||Standard Deviation|Mean
774307|NCT00746798|Primary|Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine.||Day 0 up to Day 14 post-vaccination|Safety assessments were on the Safety, intend-to-treat Population.||Participants|||Number
774308|NCT00746798|Primary|Number of Participants With Seroconversion Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine.|"Antibodies to vaccine were measured by the Plaque Reduction Neutralization Test.
Seroconversion was defined as a four-fold or greater rise in titer between pre- and post-injection samples; or a post-vaccination (Day 28) titers of ≥ 1:20 in participants with baseline titer ≤ 1:10."|Day 0 and Day 28 post-vaccination|Serum antibody levels and seroconversion were assessed in the per-protocol population.||Participants|||Number
774309|NCT00746798|Secondary|Number of Participants Developing Viremia After Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine.|Viremia is defined as number of subjects in the analysis population dose group with detected (≥ 20 Plaque forming units [pfu]/mL) viremia at the reported visit.|Day 2 up to Day 14 post-vaccination|Viremia concentrations were assessed in a randomly selected subset of the per-protocol population.||Participants|||Number
774310|NCT00746798|Primary|Geometric Mean Titers (GMTs) of Antibodies to Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine|Antibodies to the vaccine antigens were measured by the Plaque Reduction Neutralization Test.|Day 0 and Day 28 post-vaccination|Serum antibody levels were assessed in the per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
774311|NCT00746863|Primary|Difference in Postoperative Pain Using a Visual Analog Scale at 24 Hours.|At approximately twenty-four hours postoperatively patients completed a visual analog scale (VAS), which was a 10-cm numeric scale on which 0 represented “no pain” and 10 represented the” worst pain ever”.|24 hours postoperative from mid-urethral sling placement|Analysis was intention to treat. One patient in the control group was discharged before her 24 hour VAS was collected.||cm||Standard Deviation|Mean
774312|NCT00746863|Primary|Difference in Postoperative Pain Using a Visual Analog Scale at 6 Hours.|At approximately six hours postoperatively patients completed a visual analog scale (VAS), which was a 10-cm numeric scale on which 0 represented “no pain” and 10 represented the” worst pain ever”.|6 hours postoperative from mid-urethral sling placement|Intention to treat||cm||Standard Deviation|Mean
774313|NCT00746863|Secondary|Difference in Successful Voiding Trial Prior to Discharge Following Placement of Mid-urethral Sling Via the Suprapubic Approach.|Prior to discharge, patients underwent voiding trials. At our institution, in order to pass the voiding trial, they must void at least 200 cc spontaneously and have less than 100 cc as a post void residual two times in a row.|From after surgery to discharge from hospital.|||participants w/sucessful voiding trial|||Number
774314|NCT00746863|Secondary|In-hospital Medication Amounts|Secondary outcome included differences in amount of pain medication used in the hospital. This was assessed by comparing the number of pills of oral narcotics the patient took while hospitalized.|From surgery until discharge, average|||number of pills||Standard Deviation|Mean
774315|NCT00746863|Primary|Difference in Postoperative Pain Using a Visual Analog Scale at 2 Hours.|At approximately two hours postoperatively patients completed a visual analog scale (VAS), which was a 10-cm numeric scale on which 0 represented “no pain” and 10 represented the” worst pain ever”.|2 hours postoperative from mid-urethral sling placement|Analysis was intention to treat. One patient in the intervention did not have a 2 hour VAS collected.||cm||Standard Deviation|Mean
774316|NCT00746889|Other Pre-specified|Change in WOMAC Pain Subscale|WOMAC pain subscale range 0-20 (0=best, 20=worst)|baseline to 12 weeks|These patients were categorized as inflammatory or noninflammatory based on the baseline ultrasound characteristics. All patients were in the treatment group.||units on a scale||Standard Deviation|Mean
774317|NCT00746889|Primary|Change in Western Ontario and McMasters Universities Arthritis Index (WOMAC) Pain Subscale|WOMAC pain subscale range 0-20 (0=best, 20=worst)|baseline to 4 weeks|This population was defined as patients who completed the 4 week follow up assessment as per protocol.||units on a scale||Standard Deviation|Mean
774318|NCT00746941|Secondary|Participants Who Died Within 6 Months|The death event is counted under the treatment arm relative to adding mefloquine to the treatment regimen.|Day 1 up to 6 months|"Safety population: All participants who enrolled in the study and were dosed, and who have at least 1 post-baseline safety assessment.
The death event is counted under the treatment arm relative to adding mefloquine to the treatment regimen."||participants|||Number
774319|NCT00746941|Secondary|Change From Baseline to Week 4 and Week 8 in T2 Lesion Volume as Seen on Magnetic Resonance Imaging (MRI) Scans of Participants' Brains||Day 0 (baseline), Week 4, Week 8|"Participants with values at the time frames being measured. Participants with undetectable CSF JCV load at baseline by the central laboratory were not included in the efficacy analysis.
Local standard of care participants who added mefloquine at Week 4 or Week 8 were counted as being dosed under both treatment arms."||log10 mm^3||Standard Deviation|Mean
774320|NCT00746941|Secondary|Change From Baseline to Week 4 and Week 8 in T1 Lesion Volume as Seen on Magnetic Resonance Imaging (MRI) Scans of Participants' Brains||Day 0 (baseline), Week 4, Week 8|"Participants with values at the time frames being measured. Participants with undetectable CSF JCV load at baseline by the central laboratory were not included in the efficacy analysis.
Local standard of care participants who added mefloquine at Week 4 or Week 8 were counted as being dosed under both treatment arms."||log10 mm^3||Standard Deviation|Mean
774321|NCT00746941|Secondary|Participants With Gadolinium (Gd)-Enhanced Lesions at Baseline, Week 4 and Week 8 as Seen on Magnetic Resonance Imaging (MRI) Scans of Participants' Brains||Day 0 (baseline), Week 4, Week 8|"Participants with values at the time frames being measured. Participants with undetectable CSF JCV load at baseline by the central laboratory were not included in the efficacy analysis.
Local standard of care participants who added mefloquine at Week 4 or Week 8 were counted as being dosed under both treatment arms."||participants|||Number
774322|NCT00746941|Secondary|Change From Baseline to Week 4 and Week 8 in Participants' Neurological Function Using a Visual Analog Scale (VAS)|"Participants rate their neurological function on a scale of 100 mm line, where the 0 end of the scale indicates poor neurological function and 100 indicates excellent neurological function. VAS was not required for participants who had physical or cognitive impairments that limited their ability to perform the assessment.
Negative change from baseline scores indicates a worsening outcome."|Day 0 (baseline), Week 4, Week 8|"Participants with values at the time frames being measured. VAS was not required for participants who had physical or cognitive impairments that limited their ability to perform the assessment.
Local standard of care participants who added mefloquine at Week 4 or Week 8 were counted as being dosed under both treatment arms."||units on a scale||Standard Deviation|Mean
774323|NCT00746941|Secondary|Change From Baseline to Week 4 and Week 8 in Symbol Digit Modalities Test (SDMT)|"The SDMT is a simple substitution task. The test gives participants 90 seconds to pair specific numbers with given geometric figures as a measure for screening cognitive impairment. The total score is the total number of correctly completed boxes in the time allowed. The test score range is from 0 (worst outcome) to 110 (best outcome).
Negative change from baseline scores indicates a worsening outcome."|Day 0 (baseline), Week 4, Week 8|"Participants with values at the time frames being measured. SDMT was not required for participants who had physical or cognitive impairments that limited their ability to perform the assessment.
Local standard of care participants who added mefloquine at Week 4 or Week 8 were counted as being dosed under both treatment arms."||units on a scale||Standard Deviation|Mean
774324|NCT00746941|Secondary|Change From Baseline to Week 4 and Week 8 in Karnofsky Performance Status (KPS) Index Score|"The KPS Index classifies participants' functional impairment. KPS can be used to compare effectiveness of different therapies and to assess the prognosis in individual participants. KPS was recorded on an 11-point scale (0, 10, 20, 30, 40, 50, 60, 70, 80, 90, and 100.) where '0=Dead' and '100=Normal, no complaints, no evidence of disease'. The lower the KPS score, the worse the survival for most serious illnesses. The KPS index is subdivided into 3 categories: incapacitated (0 to 40), self-care (50 to 70), and normal activity (80 to 100).
Negative change from baseline scores indicate improved prognosis."|Day 0 (baseline), Week 4, Week 8|"Participants with values at the time frames being measured. Participants with undetectable CSF JCV load at baseline by the central laboratory were not included in the efficacy analysis.
Local standard of care participants who added mefloquine at Week 4 or Week 8 were counted as being dosed under both treatment arms."||units on a scale||Standard Deviation|Mean
774325|NCT00746941|Secondary|Change From Baseline to Week 4 and Week 8 in the Expanded Disability Status Scale (EDSS) Score|EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death) was calculated. Negative change scores indicate improvement.|Day 0 (baseline), Week 4 and 8|"Participants with values at the time frames being measured. EDSS was not required for participants who had physical or cognitive impairments that limited their ability to perform the assessment.
Local standard of care participants who added mefloquine at Week 4 or Week 8 were counted as being dosed under both treatment arms."||units on a scale||Standard Deviation|Mean
774326|NCT00746941|Primary|Change From Baseline to Week 8 in JC Virus (JCV) Load in Cerebrospinal Fluid (CSF)|"Change from baseline to Week 8 in JC viral load in CSF is expressed as log10 copies/mL. Negative values indicate a reduction in viral load.
Only participants with measurable baseline values are included. Post-baseline values of 'Below the Limit of Quantification' or 'Below Limit of Detection' or 'Negative' were set to 50. Log10 (50) = 1.699"|Day 0 (baseline), Week 8|"Local standard of care participants who added mefloquine at Week 4 or Week 8 were counted as being dosed under both treatment arms.
Participants with undetectable CSF JCV load at baseline were not included in the efficacy analysis. All other enrolled participants were included in the efficacy analysis if values for Week 8 were available."||log10 copies/mL||Standard Deviation|Mean
774327|NCT00746941|Primary|Change From Baseline to Week 4 in JC Virus (JCV) Load in Cerebrospinal Fluid (CSF)|"Change from baseline to Week 4 in JC viral load in CSF is expressed as log10 copies/mL. Negative values indicate a reduction in viral load.
Only participants with measurable baseline values are included. Post-baseline values of 'Below the Limit of Quantification' or 'Below Limit of Detection' or 'Negative' were set to 50. Log10 (50) = 1.699"|Day 0 (baseline), Week 4|"Local standard of care participants who added mefloquine at Week 4 or Week 8 were counted as being dosed under both treatment arms.
Participants with undetectable CSF JCV load at baseline were not included in the efficacy analysis. All other enrolled participants were included in the efficacy analysis if values for Week 4 were available."||log10 copies/mL||Standard Deviation|Mean
774328|NCT00746954|Primary|Apnea-hypopnea Index (Number of Central and Mixed Apneas/Hour of Sleep)||Overnight polysomnogram over 3 separate nights|Comparisons among Drugs (not Arms)||APNEA-HYPOPNEA/HR by drug or placebo||Standard Deviation|Mean
774922|NCT00753012|Primary|Left Ventricle Size|Size of the heart's left ventricle chamber (Left Ventricular End Diastolic Dimension; LVEDD) following 3-6 months of stimulant medication, according to cardiac ultrasound (transthoracic echocardiogram; TTE)|3-6 months|14 subjects completed endpoint TTE; one HTN subject missed the scheduled endpoint TTE appointment.||mm||Standard Deviation|Mean
774329|NCT00747006|Secondary|Lunch Plasma Glucose AOC(0-240) - Amendment 1 (Humalog Treated Type 2 Subjects)|Lunch area over the plasma glucose - time curve from time 0 (immediately before breakfast) to 240 minutes after start of lunch|0 to 240 minutes|Protocol Amendment 1 Type 2 Diabetes Mellitus Humalog Treated Subjects; 150% carbohydrate load was not done per protocol since the 200% carbohydrate load was administered||min*mg/dL||Full Range|Mean
774330|NCT00747006|Secondary|Lunch Plasma Glucose AOC(0-240) - Amendment 1 (TI Treated Type 2 Subjects)|Lunch area over the plasma glucose - time curve from time 0 (immediately before breakfast) to 240 minutes after start of lunch|0 to 240 minutes|Protocol Amendment 1 Type 2 Diabetes Mellitus Technosphere Insulin Treated Subjects; 150% carbohydrate load was not done per protocol since the 200% carbohydrate load was administered||min*mg/dL||Full Range|Mean
774331|NCT00747006|Secondary|Breakfast Plasma Glucose AOC(0-240) - Original Protocol (TI Treated Type 1 Subjects)|Breakfast area over the plasma glucose - time curve from time 0 (immediately before breakfast) to 240 minutes after start of breakfast|0 to 240 minutes|Original Protocol Type 1 Diabetes Mellitus Technosphere Insulin Treated; 0% carbohydrate load was deemed unsafe by PI||min*mg/dL||Full Range|Mean
774332|NCT00747006|Secondary|Lunch Plasma Glucose AOC (0-240) - Original Protocol (TI Treated Type 1 Subjects)|Area over the plasma glucose - time curve from time 0 (immediately before starting lunch) to 240 minutes after the start of the lunch|0 to 240 minutes|Original Protocol Type 1 Diabetes Mellitus Technosphere Insulin Treated; 50% carbohydrate load was administered but not completed due to all subjects having hypoglycemia, 0% carbohydrate load was deemed unsafe by PI||min*mg/dL||Full Range|Mean
774333|NCT00747006|Primary|Lunch Plasma Glucose Excursion - Amendment 1 (Humalog Treated Type 2 Subjects)|Excursion is the difference between plasma glucose Cmax and Cmin (Cmax-Cmin) at lunch|0 to 240 minutes|Protocol Amendment 1 Type 2 Diabetes Mellitus Humalog Treated Subjects; 150% carbohydrate load was not done per protocol since the 200% carbohydrate load was administered||mg/dL||Full Range|Mean
774334|NCT00747006|Primary|Lunch Plasma Glucose Excursion - Amendment 1 ( TI Treated Type 2 Subjects)|Excursion is the difference between plasma glucose Cmax and Cmin (Cmax-Cmin) at lunch|0 to 240 minutes|Protocol Amendment 1 Type 2 Diabetes Mellitus TI Treated Subjects; 150% carbohydrate load was not done per protocol since the 200% carbohydrate load was administered||mg/dL||Full Range|Mean
774335|NCT00747006|Primary|Breakfast Plasma Glucose Excursion - Original Protocol (TI Treated - Type 1 Subjects)|Excursion is the difference between plasma glucose Cmax and Cmin (Cmax - Cmin) at breakfast|0 to 240 minutes|Original Protocol Type 1 Diabetes Mellitus Technosphere Insulin Treated; 0% carbohydrate load was deemed unsafe by PI||mg/dL||Full Range|Mean
774336|NCT00747006|Primary|Lunch Plasma Glucose Excursion - Original Protocol (TI Treated Type 1 Subjects)|Excursion is the difference between plasma glucose Cmax and Cmin (Cmax - Cmin) at lunch|0 to 240 minutes|Original Protocol Type 1 Diabetes Mellitus Technosphere Insulin Treated; 50% carbohydrate load was administered but not completed due to all subjects having hypoglycemia, 0% carbohydrate load was deemed unsafe by PI||mg/dL||Full Range|Mean
774337|NCT00747006|Primary|Lunch Plasma Glucose Time 0 Corrected AUC(0-240) - Amendment 1 (Humalog Treated Type 2 Subjects)|"AUC (area under the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is above time 0 value.
AOC (area over the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is below time 0 value.
TIme 0 corrected AUC (0-240) = AUC - AOC"|0 to 240 minutes|Protocol Amendment 1 Type 2 Diabetes Mellitus Humalog Treated Subjects; 150% carbohydrate load was not done per protocol since the 200% carbohydrate load was administered||min*mg/dL||Full Range|Mean
774338|NCT00747006|Primary|Lunch Plasma Glucose Time 0 Corrected AUC(0-240) - Amendment 1 (TI Treated Type 2 Subjects)|"AUC (area under the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is above time 0 value.
AOC (area over the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is below time 0 value.
TIme 0 corrected AUC (0-240) = AUC - AOC"|0 to 240 minutes|Protocol Amendment 1 Type 2 Diabetes Mellitus Technosphere Insulin Treated Subjects; 150% carbohydrate load was not done per protocol since the 200% carbohydrate load was administered||min*mg/dL||Full Range|Mean
774339|NCT00747006|Primary|Breakfast Plasma Glucose Time 0 Corrected AUC(0-240) - Original Protocol (TI Treated Type 1 Subjects)|"AUC (area under the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is above time 0 value.
AOC (area over the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is below time 0 value.
TIme 0 corrected AUC (0-240) = AUC - AOC"|0 to 240 minutes|Original Protocol Type 1 Diabetes Mellitus Technosphere Insulin Treated; 0% carbohydrate load was deemed unsafe by PI||min*mg/dL||Full Range|Mean
774340|NCT00747006|Primary|Lunch Plasma Glucose Time 0 Corrected AUC (0-240) - Original Protocol (TI Treated Type 1 Subjects)|"AUC (area under the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is above time 0 value.
AOC (area over the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is below time 0 value.
TIme 0 corrected AUC (0-240) = AUC - AOC"|0 to 240 minutes|Original Protocol Type 1 Diabetes Mellitus Technosphere Insulin Treated; 50% carbohydrate load was administered but not completed due to all subjects having hypoglycemia, 0% carbohydrate load was deemed unsafe by PI||min*mg/dL||Full Range|Mean
774341|NCT00747149|Secondary|Incidence of Adverse Events and Abnormal Laboratory Values After 12 Weeks of Therapy||6 and 12 Weeks||||||
774342|NCT00747149|Secondary|Mean High Sensitivity C-reactive Protein (hsCRP) Value at Week 6 and 12||6 and 12 Weeks||||||
774343|NCT00747149|Secondary|Mean Percent Change in Total Cholesterol (TC), Low Density Lipoprotein Cholesterol (LDL-C), High-density Lipoprotein Cholesterol (HDLC) , TC/HDL-C Ratio, Non-HDL-C, Triglycerides and Apolipoprotein B (ApoB) /Apolipoprotein A1 (ApoA-1) Ratio||6 and 12 Weeks||||||
774344|NCT00747149|Secondary|Percentage of Subjects Achieving Total Cholesterol (TC)/ High-density Lipoprotein Cholesterol (HDLC) Ratio (i.e. TC/HDL < 4.0 mmol/L) at 6 and 12 Weeks of Treatment|Proportion of subjects achieving total cholesterol (TC)/ High-density lipoprotein cholesterol (HDLC) ratio (i.e. TC/HDL < 4.0 mmol/L) at 6 and 12 weeks of treatment|6 and 12 Weeks||||||
774923|NCT00753142|Secondary|To Determine if Hyperglycemia-induced Reduced Insulin Secretion is the Result of Beta-cell Exhaustion or Beta-cell Desensitization.||4 years||||||
774345|NCT00747149|Primary|Percentage of Subjects Achieving Canadian Low Density Lipoprotein Cholesterol (LDL-C) Target Goals (i.e. LDL-C ≤ 2.0 mmol/L) After 12 Weeks of Rosuvastatin Therapy|The number of subjects achieving Canadian Low density lipoprotein cholesterol (LDL-C) target goals (i.e. LDL-C ≤ 2.0 mmol/L) over the total number subjects treated after 12 weeks of rosuvastatin therapy multiplied by 100|12 Weeks|||Percentage||95% Confidence Interval|Mean
774346|NCT00747214|Secondary|Change in Fatigue (MAF Scale) Score From Baseline to Day 42|"The Multidimensional Assessment of Fatigue (MAF) scale is a self-administered, 16 item questionnaire to measure self-reported fatigue (http://www.son.washington.edu/research/maf/). The following steps were used to calculate a single score ranging from 1 (no fatigue) to 50 (severe fatigue).
Convert item #15 to a 0 to 10 scale by multiplying each score by 2.5
Sum items #1, 2, and 3
Average items #4 through 14
Add results from above Steps 1 through 3 to obtain a single score
A score was not be assigned to items #4 through 14 if a respondent indicated they did not engage any activity for reasons other than fatigue. If respondent selected “no fatigue” on item #1, a 0 was to be assigned to items #2 through 16; item #16 was not included in the global fatigue index."|Baseline and Day 42|||units on a scale||Standard Deviation|Mean
774347|NCT00747214|Secondary|Change in DAS28 Score From Baseline to Day 42|To calculate the DAS28, the number of swollen joints and tender joints should be assessed using 28-joint counts, the ESR should have been measured in mm/hour, and the patient's general health (GH) or global disease activity measured on a Visual Analog Scale (VAS) of 100 mm must be obtained. Using these data, the DAS28 could be calculated using the following formula: DAS28 = 0.56 * sqrt(tender28) + 0.28 * sqrt(swollen28) + 0.70 * ln(ESR) + 0.014 * GH. The DAS28 provides a number between 0 and 10 that indicates the current activity of RA in the subject. A DAS28 above 5.1 means high disease activity and below 3.2 indicates low activity. Remission is achieved when a DAS28 score is lower than 2.6. The DAS28 measurements were to be taken at each visit.|Baseline and Day 42|||units on a scale||Standard Deviation|Mean
774348|NCT00747214|Secondary|Improvement of ACR 20 Scores at End of Study (Day 42/Visit 5)|The percentage of subjects in each group that achieved an ACR 20 response on Day 42|Day 42|||percentage of participants|||Number
774349|NCT00747214|Primary|Change in CRP From Baseline to Day 42|The primary efficacy variable in this study was the change in CRP from Baseline (Day 1/Visit 2) to End of Study (Day 42/Visit 5). Blood samples for the analysis of serum CRP were taken at each visit.|Baseline and Day 42|||percentage change from baseline||Standard Deviation|Mean
774350|NCT00747227|Secondary|"Subject Satisfaction - Subjects Satisfied With Overall Eyesight Rated as Good or Excellent."|"Subjects indicating a subjective response to a multiple choice question, At the present time, would you say your eyesight using both eyes (with glasses or contact lenses, if you wear them) is excellent, good, fair, poor, or very poor or are you completely blind?, on a multi-item questionnaire administered by interviewer to determine subject satisfaction with their overall visual outcome at the one year visit."|One Year|Two subjects in the ZV9003 group did not complete the one year questionnaire.||participants|||Number
774351|NCT00747227|Primary|Uncorrected Distance Visual Acuity|Snellen Equivalent of 20/40 or better at one year|One Year|One subject was excluded from the analysis because the ZV9003 lens was implanted in the first eye and the ZA900 lens was implanted in the second eye. All subjects in the outcomes analysis had the same lens in both eyes.||participants|||Number
774352|NCT00747227|Secondary|Contrast Sensitivity|Contrast sensitivity is the measurement of how faded an image may become before it can clearly be seen. Contrast sensitivity was measured in photopic and mesopic conditions at the following spatial frequencies: 3.0, 6.0, 12.0, and 18 cpd (cycles per degree). Contrast sensitivity is measured in log units. A higher value for the logarithmic units translates to better contrast sensitivity.|4-6 months|Binocular contrast sensitivity testing was reported for all binocular subjects with data available at the 4-6 month visit on 120 subjects in each group. One ZA9003 subject was tested at 3.0 cpd and not tested for 6.0 cpd through 18.0 cpd (mesopic and photopic). Testing for levels 6.0 through 18.0 were not reported.||log contrast||90% Confidence Interval|Mean
774353|NCT00747227|Primary|Best Corrected Distance Visual Acuity|Snellen Equivalent visual acuity of 20/40 or better|One year|One subject was excluded from the analysis because the ZV9003 lens was implanted in the first eye and the ZA900 lens was implanted in the second eye. All subjects in the outcomes analysis had the same lens in both eyes.||participants|||Number
774354|NCT00747344|Secondary|The Change in Dermatology Life Quality Index (DLQI) From Baseline at Week 12|Scores could range from 0 to 30. A lower DLQI score represents better quality of life.|Baseline to Week 12|Participants were analyzed according to the treatment group to which they were randomized, regardless of the treatment they received.||Scores on a scale||Standard Deviation|Mean
774355|NCT00747344|Secondary|The Number of Patients With a Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12||Week 12|Participants were analyzed according to the treatment group to which they were randomized, regardless of the treatment they received.||Participants|||Number
774356|NCT00747344|Primary|The Number of Patients Who Achieved at Least a 75% Improvement in PASI (Psoriasis Area and Severity Index) at Week 12|PASI score can range from 0 (no psoriasis) to 72 (severe psoriasis).|Week 12|Participants were analyzed according to the treatment group to which they were randomized, regardless of the treatment they received.||Participants|||Number
774357|NCT00747435|Secondary|Increase in Satisfaction With EAS Compared to Preoperative Hearing Aid Condition as Measured by the HDSS.|Satisfaction is ranked from 1-5, with 1 being very dissatisfied and 5 being very satisfied. Data reported is the percentage of subjects who experienced an increase in satisfaction when using EAS compared to preoperative hearing aids.|12 months post initial activation|Only 59 subjects completed the HDSS at preop and 12 month post activation.||Participants|||Count of Participants
774358|NCT00747435|Secondary|Increased Benefit With EAS as Compared to Their Preoperative Hearing Aid Condition as Measured by the APHAB Questionnaire.|A lower score on the APHAB indicates a better performance. The global score for preoperative hearing aid use was subtracted from the global score for EAS at 12 months giving an improvement on the APHAB with EAS.|12 months post initial activation|Only 59 subjects completed the APHAB at preop and 12 months post activation.||percentage of scoring change (APHAB)||Standard Deviation|Mean
774559|NCT00749398|Secondary|Static PGA Score as Assessed by the Investigator|Static PGA was assessed at each visit by the investigator. Static PGA score ranged from 0 (no psoriasis) to 5 (extreme psoriasis). The higher the number, the more severe the psoriasis was.|Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)|Per protocol analysis.||Score on a scale||Standard Deviation|Mean
774359|NCT00747435|Secondary|Improvement on Speech Perception in the CI-only Condition as Compared to the Preoperative With Hearing Aid Condition.|CNC words are scored as the percent correct out of 50 words. The percent correct for preoperative hearing aid use was subtracted from the percent correct for CI Alone at 12 months giving an improvement on speech perception for CI Alone compared to preoperative hearing aids.|12 months post initial activation|||percentage of words correct (CNC)||Standard Deviation|Mean
774360|NCT00747435|Secondary|Improvement in Speech Perception in Noise With EAS When Compared to the Cochlear Implant Alone Condition|CUNY sentences in noise are scored as the percent correct of words in each sentence. The total percent correct for the CI Alone condition was subtracted from the total percent correct for the EAS condition at 12 months giving an improvement in speech perception with EAS compared to CI Alone.|12 months initial activation|One subject lost residual hearing immediately after surgery and was unable to use EAS. The subject was testing in cochlear implant alone condition.||percentage of words correct (CUNY)||Standard Deviation|Mean
774361|NCT00747435|Primary|Improvement in Speech Perception in Noise With EAS When Compared to the Preoperative Hearing Aid Alone Condition.|CUNY sentences in noise are scored as the percent correct of words in each sentence. The total percent correct for preoperative hearing aid use was subtracted from the total percent correct for EAS at 12 months giving a percentage point improvement in speech perception with EAS.|12 months post initial activation|One subject lost residual hearing immediately following surgery and was unable to use EAS. This subject was tested with the cochlear implant alone and is not included in this analysis.||percentage of words correct (CUNY)||Standard Deviation|Least Squares Mean
774362|NCT00747461|Secondary|Treatment Durability|need for additional treatments within specified period|12 months|study terminated-no subjects analyzed.|||||
774363|NCT00747461|Primary|Improvement in Luminal Patency Following Cryospray Treatment||30 days|study terminated by Sponsor-data not analyzed|||||
774364|NCT00747474|Primary|Plasma Decay Half-Life (t1/2) of TLC-U2|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.||hour||Standard Deviation|Mean
774365|NCT00747474|Primary|Plasma Decay Half-Life (t1/2) of TLC-U1|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.||hour||Standard Deviation|Mean
774366|NCT00747474|Primary|Plasma Decay Half-Life (t1/2) of Topotecan|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.||hour||Standard Deviation|Mean
774367|NCT00747474|Primary|Plasma Decay Half-Life (t1/2) of S,S-TLC388|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.||hour||Standard Deviation|Mean
774368|NCT00747474|Primary|Plasma Decay Half-Life (t1/2) of S,R-TLC388|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.||hour||Standard Deviation|Mean
774369|NCT00747474|Primary|Dose-normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of TLC-U2|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.||hr*ng/mL||Standard Deviation|Mean
774370|NCT00747474|Primary|Dose-normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of TLC-U1|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.||hr*ng/mL||Standard Deviation|Mean
774371|NCT00747474|Primary|Dose-normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of Topotecan|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.||hr*ng/mL||Standard Deviation|Mean
774372|NCT00747474|Primary|Dose-normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of S,S-TLC388|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.||hr*ng/mL||Standard Deviation|Mean
774373|NCT00747474|Primary|Dose-normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of S,R-TLC388|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.||hr*ng/mL||Standard Deviation|Mean
774374|NCT00747474|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of TLC-U2|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.||hour||Standard Deviation|Mean
774580|NCT00749931|Post-Hoc|Re-excision Lumpectomy Procedures Due to Positive Margin on Main Specimens||Up to 2 months post-surgery|||percentage of participants|||Number
774375|NCT00747474|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of TLC-U1|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.||hour||Standard Deviation|Mean
774376|NCT00747474|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Topotecan|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.||hour||Standard Deviation|Mean
774377|NCT00747474|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of S,S-TLC388|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.||hour||Standard Deviation|Mean
774378|NCT00747474|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of S,R-TLC388|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h|Patients complete cycle 1 and 2 treatments without major protocol deviation.||hour||Standard Deviation|Mean
774379|NCT00747474|Primary|Maximum Observed Dose-normalized Plasma Concentration (Cmax) of TLC-U2|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1h, 1h30m, 2h, 4h, 8h|Patients complete cycle 1 and 2 treatments without major protocol deviation.||ng/mL||Standard Deviation|Mean
774380|NCT00747474|Primary|Maximum Observed Dose-normalized Plasma Concentration (Cmax) of TLC-U1|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.||ng/mL||Standard Deviation|Mean
774381|NCT00747474|Primary|Maximum Observed Dose-normalized Plasma Concentration (Cmax) of Topotecan|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.||ng/mL||Standard Deviation|Mean
774382|NCT00747474|Primary|Maximum Observed Dose-normalized Plasma Concentration (Cmax) of S,S-TLC388|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.||ng/mL||Standard Deviation|Mean
774383|NCT00747474|Primary|Maximum Observed Dose-normalized Plasma Concentration (Cmax) of S,R-TLC388|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.||ng/mL||Standard Deviation|Mean
774384|NCT00747474|Primary|Number of Participants With Adverse Events|Number of participants with AEs that occurred during treatment and follow-up period (30 days after last treatment). Drug-related AEs and SAEs were followed until resolved or stabilized. AEs were classified by the investigator according to severity graded using CTCAE version 3.0 and relationship to study drug. The severity scale is: Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening or disabling, Grade 5= Death related to AE|an average of 6 months|Patients received at least one dose of Lipotecan||participants|||Number
774385|NCT00747474|Secondary|Anti-tumor Activity|Patients were evaluated by tumor assessment using RECIST guidelines. Possible evaluations include: Complete Response (CR): disappearance of all target lesions. Partial Response (PR): at least a 30% decrease in the size of target lesions. Progressive Disease (PD): at least a 20% increase in the size of target lesions. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|From start of treatment assessed every 2 cycles up to 2.5 years|Patients received at least one dose of Lipotecan.||participants|||Number
774386|NCT00747474|Primary|Maximum Tolerated Dose (MTD) of Lipotecan|MTD is the highest dose of drug that did not cause an unacceptable side effect (= Dose Limiting Toxicity (DLT)). A 3+3 study design was used to determine MTD. The MTD was the highest dose level at which 0 of 3 or 1 of 6 patients experience a DLT, with the next higher dose having at least 2 of 3 or 2 of 6 patients experiencing a DLT.|First treatment to toxicity up to 42 days|Patients received at least one dose of Lipotecan.||mg/m^2|||Number
774387|NCT00747552|Secondary|Median Bladder Pressure for All Measurements|Intra-abdominal Pressure (IAP) measurements will be tabulated and frequency distributions determined for patients with and without any clinical/surgical abdominal pathology. Median and quartile values will be assessed in order to describe normative values. In patients with clinical abdominal pathology (abdominal distention, necrotizing enterocolitis, abdominal wall defects, diaphragmatic hernia, etc), sequential evaluation of IAP will be done to try to identify thresholds for Intra-abdominal Hypertension (IAH).|3 years|18 of the neonates required staged abdominal surgery for various abdominal abnormalities or disease, while 12 of the neonates were ill due to PPHN, sepsis, or hydrops. All analysis was per protocol.||mmHg||Inter-Quartile Range|Median
774388|NCT00747552|Primary|Intra-abdominal Pressure(IAP) Measurements in NICU Patients.|Intra-abdominal Pressure (IAP) measurements were taken using an electronic pressure transducer via an indwelling urinary catheter. Measurements were obtained every 2-4 hours while the urinary catheter remained in place. This will be used to determine feasability of using a urinary catheter and electronic pressure transducer system to determine IAP. A total of 1219 measurements were obtained from 30 subjects.|3 years|18 of the neonates required staged abdominal surgery for various abdominal abnormalities or disease, while 12 of the neonates were ill due to PPHN, sepsis, or hydrops. All analysis was per protocol.||IAP measurements|||Number
774924|NCT00753142|Primary|First Phase Insulin Release (FPIR)|Calculated as the sum of the insulin levels at 2, 3, 4, and 5 min after infusion|at the end of 20 hours|||microunits/ml||Standard Deviation|Mean
774389|NCT00747565|Primary|Mean Binocular Distance Corrected Near Visual Acuity in Snellen|Mean binocular near visual acuity with distance correction in place measured at 33 cm; Mean is reported in Snellen (e.g. 20/20, 20/40, etc.), standard deviation reported in ETDRS (Early treatment diabetic retinopathy study)eye chart log units.|One year|Binocular subjects at one year available for testing for both studies combined.||Mean Snellen Line (with ETDRS line SD)||Standard Deviation|Mean
774390|NCT00747565|Primary|Number of Participants That Achieved Best Corrected Distance Visual Acuity of 20/40 or Better in the First Eye.|"Number of participants that achieved a best corrected distance visual acuity of 20/40 or better in the first eye. As most subjects were implanted bilaterally,first eye refers to the first implanted eye of each subject."|One year|First eye results from subjects at one year in both the original study and the expansion study combined.||Participants (First Eyes only)|||Number
774391|NCT00747617|Secondary|Serum Testosterone Responses to hCG||-0.5, 0, 0.5, 24 hrs||||||
774392|NCT00747617|Primary|Serum 17OHP Responses to hCG|Assess serum 17OHP levels following each dose of hCG adminstration in PCOS and normal subjects|24 hrs post dose|PCOS and Normal groups were analyzed according to peak 17OHP levels at each dose of r-hCG.||ng/ml||Standard Error|Mean
774393|NCT00747643|Secondary|A Measure of the Subjective Expected Value of a Cigarette|The cigarette choice procedure (Kidorf, Stitzer, and Griffiths, 1995) is a measure of the desire to smoke a cigarette. Participants are asked to hypothetically choose between smoking a cigarette now or receiving a small amount of money (from 10 cents up to $6 in increments of 10 cents). A crossover ($) value, at and above which participants prefer money, is obtained (Reid, Palmar, Raghavan, and Flammino, 2007).|3 weeks per participant|Per Protocol||Dollars||Standard Error|Mean
774394|NCT00747643|Primary|Cue-provoked Cravings|"Strength of Craving 0 (lowest) to 20 (highest). One item 0 - 20 Likert scale How strong was your craving to smoke a cigarette?"|3 weeks per participant|Per Protocol||Scores on a scale||Standard Error|Mean
774395|NCT00747643|Secondary|Smoking Topography - Number of Puffs on a Cigarette|# Puffs = total number of puffs taken at Assessment Session.|3 weeks per participant|Per Protocol||Puffs on a Cigarette||Standard Error|Mean
774396|NCT00747643|Primary|Tonic Craving Score (QSU) Based on Self Reports|Tonic Craving 1 (lowest) to 7 (highest). The Questionnaire of Smoking Urges (QSU), our primary measure of tonic craving, is a 32-item instrument, including 2 separate factor scales that roughly correspond to the desire to smoke for its pleasurable effects (positive reinforcement) or to remove unpleasant feelings of negative affect or withdrawal (negative reinforcement) (Tiffany and Drobes 1991). Following overnight abstinence, each session included assessment of tonic craving, reactivity (including craving) to smoking cues.|3 weeks per participant|Per Protocol||Scores on a scale||Standard Error|Mean
774397|NCT00747747|Secondary|Recovery of Sinusitis Per Clinical Assessment (Outcome Measure Percentage of Patients)|Clinical assessment of healing of the sinusitis episode (Outcome Measure Percentage of patients healed. Healing was assessed clinically by the physician as recovery of the condition prior to the diagnosis of the episode of sinusitis, without need of medical treatment.|After two weeks|||percentage of patients|||Number
774398|NCT00747747|Secondary|Recovery of Sinusitis Per Clinical Assessment(Outcome Measure Percentage of Patients)|Clinical assessment of healing of the sinusitis episode(Outcome Measure Percentage of patients healed). Healing was assessed clinically by the physician as recovery of the condition prior to the diagnosis of the episode of sinusitis, without need of medical treatment.|After one week|Eligibility according to in/ex criteria and compliance with study requirements||percentage of patients|||Number
774399|NCT00747747|Primary|Presence of Mucus in the Paranasal Sinuses (Outcome Measure Percentage of Patients)|Mucus detection in paranasal sinuses by clinical assessment(Outcome Measure Percentage of patients)|After two weeks|||percentage of patients|||Number
774400|NCT00747747|Secondary|FACIAL PAIN Daily Retrospective Ranking of Symptoms as Assessed by the Subject|"Patient's daily diary retrospective ranked assessment of symptoms (0,1,2,3 with 0 = no symptoms; frequencies of patients with rank 0 were compared as outcome measure between groups."|After two weeks|||percentage of patients|||Number
774401|NCT00747747|Secondary|FACIAL PAIN Daily Retrospective Ranking of Symptoms as Assessed by the Subject|"Patient's daily diary retrospective ranked assessment of symptoms (0,1,2,3 with 0 = no symptoms; frequencies of patients with rank 0 were compared as outcome measure between groups"|After one week|Eligibility per in/ex criteria and compliance with study requirements and diary completion requirements||percentage of patients|||Number
774402|NCT00747747|Primary|Presence of Mucus in the Paranasal Sinuses (Outcome Measure Percentage of Patients)|Mucus detection in paranasal sinuses by clinical assessment(Outcome measure Percentage of patients)|After one week|The patients were eligible according to inclusion and exclusion criteria and were compliant with the study requirements.||percentage of patients|||Number
774403|NCT00747812|Primary|Number of Days With 4 or More Hours of Headache||12 Weeks|||Days||Standard Deviation|Mean
774404|NCT00747812|Primary|Number of Hours of Headache||12 weeks|||Hours||Standard Deviation|Mean
774405|NCT00747916|Secondary|To Determine if CryoSpray Causes a Pleurodesis Effect. To Determine if CryoSpray Affects Production of Malignant Effusion Within the Treated Pleural Cavity. To Determine if Pleural Cavity Treatment With CryoSpray is Dosimetry Dependent.||1 year|zero participants analyzed due to early termination of study|||||
774406|NCT00747916|Primary|To Reduce Tumor Burden in the Pleural Space, as Determined by Visual Inspection and Biopsy of the Treatment Sites 2-5 Days Post Treatment. Safety Endpoint Clinical and Radiographic Status at 30 Days Post CryoSpray Treatment and Adverse Events.||1 year|zero participants analyzed due to early termination of study|||||
774407|NCT00748072|Primary|The Primary Outcome Measure Was the Incidence of Post-biopsy Bleeding Complications.||Immediately post-biopsy and 24 hours post-biopsy.|||participants|||Number
774408|NCT00748085|Secondary|Consists of a Measure of Treatment Efficacy and Improvement in Luminal Patency Assessed by Visual Inspection.||1 year|no analysis conducted. Study terminated for business reasons|||||
774409|NCT00748085|Primary|Efficacy of the Cryogen on a Tumor Evaluated by Histopathological Data and Visual Inspection Along With Visual Confirmation of Absence of Scarring and Stricturing of the Airway. The Primary Safety Endpoint is the Reporting of All Adverse Events.||1 year|no analysis conducted-study terminated for business reasons|||||
774971|NCT00753363|Secondary|Fitness|Maximal oxygen consumption (VO2max) on a treadmill|Baseline and 6 month|||L/min||Standard Error|Mean
774972|NCT00753363|Secondary|Body Weight||Baseline and 6 month|||kg||Standard Error|Mean
774410|NCT00748098|Secondary|Number of Participants Who Self-reported “Very Satisfied” or “Satisfied” With the Investigational Product at Week 4/10 Using LOCF|"Participant satisfaction with RLS medication was captured on a seven-point ordinal scale. The scale asked Overall, how satisfied are you with the medication you received for the treatment of your RLS symptoms during the study. The participant responses ranged from 1 (Very satisfied) to 7 (Very dissatisfied). A satisfied response was scored a 2."|Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: The number of participants assessed varied due to missing/incomplete data.||participants|||Number
774411|NCT00748098|Secondary|"Number of Participants Who Were Defined as Clinical Global Impression of Illness (CGI-I) Scale Responders at Week 4/10 Using LOCF"|The CGI-I scale allows the investigator to rate the participant’s global improvement or worsening compared with the condition at baseline (i.e., Day 1), and whether or not the change is thought to be due to treatment with study medication. The scale is rated from 1-7 (1=Very much improved to 7=Very much worse). Participants with a score of 1 (“Very much improved”) or 2 (“Much improved”) are considered to be responders.|Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: The number of participants assessed varied due to missing/incomplete data.||participants|||Number
774412|NCT00748098|Secondary|Adjusted Mean Change From Baseline in the Clinical Global Impression of Illness – Severity (CGI-S) Score at Week 4/10 Using LOCF|The CGI-S scale allows the investigator to rate the severity of participants’ illness considering their total clinical experience with the participant population being studied and based on all information available at the time of rating. The scale is rated from 1-7 (1=Normal, not at all ill; 7=Among the most extremely ill patients). Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: The number of participants assessed varied due to missing/incomplete data.||scores on a scale||Standard Error|Least Squares Mean
774413|NCT00748098|Secondary|Number of Participants Who Responded Affirmatively to Each of the 4 Items of the Participant-completed Patient Global Impression of Therapy at Week 4/10 Using LOCF|"Each participant completed the participant-completed Patient Global Impression questionnaire at the end of each Treatment Period (Weeks 4 and 10) or Early Withdrawal. This instrument was developed to capture a participant’s subjective assessment of therapy and is composed of the following 4 questions with dichotomous (Yes or No) responses: “Helped me sleep,” Helped me fall asleep faster,” “Helped me sleep longer,” and “Helped me get a better night’s sleep.”"|Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: The number of participants assessed varied due to missing/incomplete data.||participants|||Number
774414|NCT00748098|Secondary|Adjusted Mean Change From Baseline in the SIT MDS (Mean Leg Discomfort Score), Mean of Scores From 0 to 60 Minutes, at Week 4/10|During the SIT, participants sat in bed with legs extended for 1 hour and rated their leg discomfort on a visual analog scale every 5 minutes (range 0-100, 0=none, higher numbers indicate more discomfort). The SIT MDS is the average rating of leg discomfort during the specified time frame. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects. Only results from SITs performed before a PSG assessment and of at least 60 minutes in length are included in the analysis.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: The number of participants assessed varied due to missing/incomplete data.||scores on a scale||Standard Error|Least Squares Mean
774415|NCT00748098|Secondary|Adjusted Mean Change From Baseline in the Suggested Immobilization Test (SIT) PLM Index at Week 4/10|During the SIT, participants sat in bed with legs extended for 1 hour and were asked to rate their leg discomfort on a 100 millimeters visual analog scale every 5 minutes (score of 0-100, 0=none, higher numbers indicate more discomfort) and PLMs were assessed. The SIT-PLM Index is defined as the number of PLMs per hour during the SIT. Mean change from baseline was adjusted for treatment, pooled center, and period effects. Only results from SITs performed before a PSG assessment and of at least 60 minutes in length are included in the analysis.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: The number of participants assessed varied due to missing/incomplete data.||number of PLMs per hour||Standard Error|Least Squares Mean
774416|NCT00748098|Secondary|Adjusted Mean Change From Baseline in the Wake After Sleep Onset (WASO) Measured by Polysomnography (PSG) at Week 4/10 Using LOCF.|Wake After Sleep Onset (WASO) is defined as the total amount of time spent awake after falling asleep until the end of PSG recording. This endpoint is measured objectively by PSG. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.||minutes||Standard Error|Least Squares Mean
774417|NCT00748098|Secondary|Adjusted Mean Change From Baseline in the Sleep Efficiency Measured by Polysomnography (PSG) at Week 4/10 Using LOCF|Sleep efficiency is a percentage that is calculated by dividing total sleep time by the amount of time the participant was in bed during the PSG. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effect.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.||minutes/hour||Standard Error|Least Squares Mean
774465|NCT00748241|Primary|Implant Survival Rate|An implant that has failed to osseointegrate, lost its osseointegration or fractured will be considered a failure effective from the date of removal. Implant Survival Rate will be calculated using the Kaplan-Meyer method based on the number of placed implants. Patients who discontinued the study after the last implant failure do not affect the cumulative survival rate.|At follow-up visit: 2 years after implants have been loaded|Population includes subjects who completed 24 month visit.||Percentage of implants|Participants||Number
774418|NCT00748098|Secondary|Adjusted Mean Change From Baseline in the Total Sleep Time Measured by Polysomnography (PSG) at Week 4/10 Using LOCF|Total sleep time is the number of minutes participants slept on average during the 8-hour polysomnography. Scoring of PSG data to yield measure of total sleep time was conducted at a central site in the United States. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effect.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.||minutes||Standard Error|Least Squares Mean
774419|NCT00748098|Secondary|Number of Participants With no Self-reported Awakenings (SPSD) Due to RLS at Week 4/10 Using LOCF|Each day upon awakening, participants recorded, using the SPSD, the number of awakenings due to RLS they experienced the previous night. Number of awakenings was calculated for each visit by averaging the last 7 available diary days. Only participants with at least 4 days of diary data available (not in consecutive order) at any visit were included in the analysis.|Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: The number of participants assessed varied due to missing/incomplete diary data.||participants|||Number
774420|NCT00748098|Secondary|Adjusted Mean Change From Baseline in the Self-reported Number of Hours Spent Awake During the Night (SPSD) Due to RLS at Week 4/10 Using LOCF|Each day upon awakening, participants recorded, using the SPSD, the total number of hours spent awake the previous night due to RLS. Response to number of hours awake was calculated for each visit by averaging the last 7 available diary days. Only participants with at least 4 days of diary data available (not in consecutive order) at any visit were included in the analysis. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: The number of participants assessed varied due to missing/incomplete diary data.||hours||Standard Error|Least Squares Mean
774421|NCT00748098|Secondary|Adjusted Mean Change From Baseline in the Number of Awakenings Measured Objectively by Polysomnography at Week 4/10 Using LOCF|The number of awakenings was measured by PSG and is defined as the number of wake periods lasting at least 1 minute. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.||awakenings||Standard Error|Least Squares Mean
774422|NCT00748098|Secondary|Adjusted Mean Change From Baseline in Participant’s Ratings of Feeling Rested Upon Awakening as Measured by the Subjective Post Sleep Diary (SPSD) at Week 4/10 Using LOCF.|Each day upon awakening, participants rated how rested they felt upon awakening on an 11-point scale (0=poor to 10=excellent) using the SPSD. Response to feeling rested upon awakening was calculated for each visit by averaging the last 7 available diary days. Only participants with at least 4 days of diary data available (not in consecutive order) at any visit were included in the analysis. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: The number of participants assessed varied due to missing/incomplete diary data.||scores on a scale||Standard Error|Least Squares Mean
774423|NCT00748098|Secondary|Adjusted Mean Change From Baseline in Sleep Quality at Week 4/10 as Measured by the Subjective Post Sleep Diary (SPSD) Using LOCF|Each day upon awakening, participants rated their overall sleep quality for the previous night on an 11-point scale (0=poor to 10=excellent) using the SPSD. Response to sleep quality was calculated for each visit by averaging the last 7 available diary days. Only participants with at least 4 days of diary data available (not in consecutive order) at any visit were included in the analysis. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: The number of participants assessed varied due to missing/incomplete diary data.||scores on a scale||Standard Error|Least Squares Mean
774424|NCT00748098|Secondary|Number of PLMAI Responders at Week 4/10 Using LOCF|PLMAI is defined as the number of PLMs associated with arousal per hour of sleep. Participants with <=5 PLMAI were evaluated as responders.|Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.||participants|||Number
774425|NCT00748098|Secondary|Adjusted Mean Change From Baseline in Periodic Limb Movements Causing Awakening (PLMAWI) at Week 4/10 as Measured by Polysomnography Using LOCF|PLMAWI is defined as the number of PLMs (involuntary leg movements) that caused participants to wake up per hour of sleep. It is calculated by dividing the number of PLMs causing awakening by the total number of hours of sleep. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.||number of PLMs/total hours of sleep||Standard Error|Least Squares Mean
774499|NCT00748657|Secondary|Frequency and Severity of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0||Up to 5 years||||||
774500|NCT00748657|Secondary|Overall Survival|The observed length of life from entry into the study to death or the date of last contact.|From study entry to death or last contact, up to 5 years.|Eligible and treated patients.||Months||95% Confidence Interval|Median
774426|NCT00748098|Secondary|Adjusted Mean Change From Baseline in the Percentage of Total Sleep Time Spent in the REM Sleep Stage at Week 4/10|Percentage of stage REM sleep time was defined as the time spent in stage REM sleep divided by total sleep time. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.||percentage of total sleep time||Standard Error|Least Squares Mean
774427|NCT00748098|Secondary|Adjusted Mean Change From Baseline in Time Spent in the REM (Rapid Eye Movement) Sleep Stage at Week 4/10 as Measured by Polysomnography Using LOCF|In REM sleep, a participant’s breathing becomes more rapid, irregular, and shallow; eyes jerk rapidly; and limb muscles are temporarily paralyzed. Brain waves during this stage increase to levels experienced when a person is awake. This is the stage when most dreams occur. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.||minutes||Standard Error|Least Squares Mean
774428|NCT00748098|Secondary|Adjusted Mean Change From Baseline in the Percentage of Total Sleep Time Spent in the N3 Sleep Stage at Week 4/10|Percentage of stage N3 sleep time was defined as the time spent in stage N3 sleep divided by total sleep time. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.||percentage of total sleep time||Standard Error|Least Squares Mean
774429|NCT00748098|Secondary|Mean Change From Baseline in the Total Time Spent in Stage N3 Sleep Time at Week 4/10 Measured by PSG Using LOCF|Stage N3 is referred to as deep sleep; it is very difficult to wake a participant in this stage of sleep. In deep sleep, there is no eye movement or muscle activity. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.||minutes||Standard Error|Least Squares Mean
774430|NCT00748098|Secondary|Adjusted Mean Change From Baseline in the Percentage of Total Sleep Time Spent in the N2 Sleep Stage at Week 4/10|Percentage of stage N2 sleep time was defined as the time spent in stage N2 sleep divided by total sleep time. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.||percentage of total sleep time||Standard Error|Least Squares Mean
774431|NCT00748098|Secondary|Adjusted Mean Change From Baseline in Time Spent in the N2 Sleep Stage as Measured by Polysomnography at Week 4/10 Using LOCF|In stage N2 of sleep, eye movement stops and brain waves become slower, with only an occasional burst of rapid brain waves. Participants may also experience spontaneous periods of muscle tone mixed with periods of muscle relaxation. During this stage, muscular activity, and conscious awareness of the external environment disappears. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.||minutes||Standard Error|Least Squares Mean
774432|NCT00748098|Secondary|Adjusted Mean Change From Baseline in the Percentage of Total Sleep Time Spent in the N1 Sleep Stage at Week 4/10 Using LOCF|Percentage of stage N1 sleep time was defined as the time spent in stage N1 sleep divided by total sleep time. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.||percentage of total sleep time||Standard Error|Least Squares Mean
774441|NCT00748189|Secondary|Number of Participants With at Least One Grade 3/Grade 4 Myelosuppression (Anemia, Neutropenia, and Thrombocytopenia)|Participants with a Grade 3 or Grade 4 myelosuppression (anemia, neutropenia, and thrombocytopenia) are presented by treatment cycle. Myelosuppression is defined as the decrease in the ability of the bone marrow to produce blood cells. AEs were graded according to NCI common terminology criteria for adverse events (CTCAE) grade, version 3.0 (1, mild; 2, moderate; 3, severe; 4, life-threatening/disabling; 5, death).|From the first dose of study medication to 60 days after the last dose of study medication and until follow-up for SAEs unless initiation of subsequent anti-CLL therapy (Median follow-up approximately 29.3 months)|Safety Population||Participants|||Number
789794|NCT00867529|Primary|Disease Relapse Rate|The effectiveness of pre- and post-transplant rituximab in decreasing the rate of relapse will be evaluated.|At 18 months|||Participants|||Count of Participants
774433|NCT00748098|Secondary|Adjusted Mean Change From Baseline in Time Spent in N1 Sleep as Measured by Polysomnography at Week 4/10 Using LOCF|Stage N1 is considered “light sleep,” during which participants drift in and out of sleep and can be awakened easily. In this stage, the eyes move slowly and muscle activity slows. This stage is sometimes referred to as “somnolence” or “drowsy sleep.” Sudden twitches and hypnic jerks may be associated with the onset of sleep during N1. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.||minutes||Standard Error|Least Squares Mean
774434|NCT00748098|Secondary|Adjusted Mean Change From Baseline in the Item 4 (Sleep Disturbance) Scores of the IRLS Rating Scale at Week 4/10 Using LOCF|"The IRLS is a measure of RLS disease severity. Item 4 of the IRLS evaluates RLS-related sleep impairment. It asks: In the past week, how severe was your sleep disturbance due to your RLS symptoms?. The item is participant rated using a 5-point scale, where 0 is the absence of any sleep disturbance and 4 is very severe disturbance. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects."|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. An additional 4 participants (2 in each treatment group) were excluded from the analysis due to missing/incomplete data.||scores on a scale||Standard Error|Least Squares Mean
774435|NCT00748098|Secondary|Adjusted Mean Change From Baseline in the International Restless Legs Rating Scale (IRLS) Total Score at Week 4/10 Using LOCF|The IRLS is a measure of RLS disease severity. Ten items (individually scored from 0 to 4) are included that assess the impact of symptoms on participants’ mood, daily life, and activities. The total scale score is a sum of all of the individual item scores and ranges from 0-40 points, with 40 being the most severe. The scale assesses symptoms over the week prior to measurement. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. An additional 4 participants (2 in each treatment group) were excluded from the analysis due to missing/incomplete data.||scores on a scale||Standard Error|Least Squares Mean
774436|NCT00748098|Secondary|Adjusted Mean Change From Baseline in Periodic Limb Movements Associated With Arousal (PLMAI) at Week 4/10 as Measured by Polysomnography Using LOCF|PLMAI is defined as the number of Periodic Limb Movements (PLMs or involuntary jerks of the legs that cause a participant to arouse from sleep per hour of sleep). Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.||limb movements per hour||Standard Error|Least Squares Mean
774437|NCT00748098|Primary|Adjusted Mean Change From Baseline in Wake Time During Sleep (WTDS) at Week 4/10 Measured by Polysomnography (PSG) (Sleep Study) Using Last Observation Carried Forward (LOCF)|"PSG is a comprehensive recording of the bio-physiological changes that occur during sleep. It is also known as a sleep study that monitors participants as they sleep or try to sleep. WTDS, defined as the total amount of time spent awake after falling asleep until the last awakening, was measured by PSG. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects."|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.||minutes||Standard Error|Least Squares Mean
774438|NCT00748189|Secondary|Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM|Immunoglobulins, or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Low levels indicate immuno-suppression. IgA, IgG, and IgM were measured in the blood samples of the participants. Baseline IgA, IgG, and IgM values are the last pre-dose assessment values performed on Cycle 1 Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|From start of treatment to the last study visit/withdrawal visit (Median follow-up approximately 29.3 months)|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Safety Population.||Gram per liter||Standard Deviation|Mean
774439|NCT00748189|Secondary|Number of Participants Who Received no Transfusion or at Least One Transfusion During the Study|Participants who received no transfusion and at least one transfusion during the study are presented. Participants who took any blood products are counted in this table.|From start of treatment to the last study visit/withdrawal visit (Median follow-up approximately 29.3 months)|Safety Population||Participants|||Number
774440|NCT00748189|Secondary|Number of Participants With Autoimmune Hemolytic Anaemia (AIHA) Disease|"AIHA is a disease where the body's immune system fails to recognize red blood cells as self and begins destroying these red blood cells. The number of participants diagnosed with AIHA are presented."|From the first dose of study medication to 60 days after the last dose of study medication and until follow-up for SAEs unless initiation of subsequent anti-CLL therapy (Median follow-up approximately 29.3 months)|Safety Population||Participants|||Number
775855|NCT00754065|Secondary|Number of Spotting-only Episodes in Reference Period 3|Reference Period 3 is defined as Day 181 to Day 270 during study treatment.|From Day 181 to Day 270|All participants in FAS with assessment for this outcome measure||Episodes||Standard Deviation|Mean
774442|NCT00748189|Secondary|Number of Participants With AEs and SAEs of Maximum Severity of Grade 3 or Higher|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs. Maximum severity grades were evaluated according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version 3.0 (1, mild; 2, moderate; 3, severe; 4, life-threatening/disabling; 5, death).|From the first dose of study medication to 60 days after the last dose of study medication and until follow-up for SAEs unless initiation of subsequent anti-CLL therapy (Median follow-up approximately 29.3 months)|Safety Population||Participants|||Number
774443|NCT00748189|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.|From the first dose of study medication to 60 days after the last dose of study medication and until follow-up for SAEs unless initiation of subsequent anti-CLL therapy (Median follow-up approximately 29.3 months)|Safety Population||Participants|||Number
774444|NCT00748189|Secondary|Change From Baseline in Health Related Quality of Life (HRQOL)|HRQOL was assessed using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTCQLQC30), Chronic Lymphocytic Leukemia module (EORTC QLQ-CLL16), EuorQoL-Five Dimension (EQ-5D), and HCQ. Period (P)1 (Day 85, Day 169, Day 253) and P2 (scheduled follow-up (FU) and withdrawal visits) analysis were considered. Baseline (BL) for P1 was defined as score from screening visit and BL for P2 was defined as the last on-treatment score. The 2 principal QoL outcomes were pre-specified as the Global Health scale (GHS/QOL) of the EORTC QLQ-C30 and fatigue scale of the EORTC QLQ-CLL16. For EORTC QLQ-C30,GHS/Qol, the possible scale range was 0-100 (with 100 being 'best') and a positive difference from BL is indicative of better functioning (range -100 to +100). For the EORTC QLQ-CLL16 fatigue scale, the possible scale range was 0-100 (with 0 being 'best') and a negative difference from BL represents an improvement in fatigue (range -100 to +100).|From randomization until the 259th PFS event occurred (Median follow-up approximately 29.3 months)|ITT population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||Scores on a scale||Standard Deviation|Mean
774445|NCT00748189|Secondary|Dose-normalized AUC(0-6) and AUC(0-inf) of Chlorambucil and Dose-normalized AUC(0-6) of Phenylacetic Acid Mustard (PAAM)|Blood samples for the determination of serum concentrations of chlorambucil and its metabolite PAAM were collected from participants in a substudy on Cycle 3 Day 1. The area under the plasma concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC[0-inf]) and over 6 hours (AUC[0-6]) of chlorambucil and AUC(0-6) of PAAM normalized to the administered dose was determined as a measure of exposure and compared to reference data from a prior study (LEUA1001) [No NCT number available for this study; GlaxoSmithKline Document Number RM1998/00449/00].|Cycle 3 Day 1|Chlorambucil/PAAM pharmacokinetic (PK) Population (substudy): all participants for whom a chlorambucil/PAAM sample is obtained and analyzed.||Hours*nanogram/milliliter/milligram||Standard Deviation|Geometric Mean
774446|NCT00748189|Secondary|Dose-normalized Cmax of Chlorambucil and Phenylacetic Acid Mustard (PAAM)|Blood samples for the determination of serum concentrations of chlorambucil and its metabolite PAAM were collected from participants in a substudy on Cycle 3 Day 1. The maximum observed concentration (Cmax) of chlorambucil and PAAM normalized to the administered dose was determined as a measure of exposure and compared to reference data from a prior study (LEUA1001) [No NCT number available for this study; GlaxoSmithKline Document Number RM1998/00449/00].|Cycle 3 Day 1|Chlorambucil/PAAM pharmacokinetic (PK) Population (substudy): all participants for whom a chlorambucil/PAAM sample is obtained and analyzed.||nanograms per milliliter per milligram||Standard Deviation|Geometric Mean
774447|NCT00748189|Secondary|Plasma Half Life (t1/2) of Ofatumumab|The terminal half-life (t1/2) of ofatumumab is defined as the time required for the plasma concentration of ofatumumab to reach half of its original concentration. Blood samples were collected to assess the plasma half-life of ofatumumab. Blood samples were collected from participants who received ofatumumab plus chlorambucil pre-dose and 0.5 hours after the end of the ofatumumab infusion at treatment Cycle 1 and Cycle 4 (Days 1, 8, and 85). In addition, pre-dose samples were collected prior to ofatumumab administration at Cycles 2, 3, 5, 6, 9 and 12 (Days 29, 57, 113, 141, 225 and 309), depending on the duration of the treatment. Samples were also collected during clinic visits on Day 15 (during Cycle 1) and Day 43 (during Cycle 2) and at 1, 3, and 6 months post-treatment.|Cycle 4 Day 1|PK Population||hours||Geometric Coefficient of Variation|Geometric Mean
774448|NCT00748189|Secondary|Vss of Ofatumumab|Volume of distribution at steady state (Vss) is defined as the distribution of a drug between plasma and the rest of the body at steady state. Blood samples were collected from participants who received ofatumumab plus chlorambucil at predose and 0.5 hour after the end of the ofatumumab infusion at treatment Cycle 1 and Cycle 4 (Days 1, 8, and 85). In addition, pre-dose samples were collected prior to ofatumumab administration at Cycles 2, 3, 5, 6, 9 and 12 (Days 29, 57, 113, 141, 225 and 309), depending on the duration of the treatment. Samples were also collected during clinic visits on Day 15 (during Cycle 1) and Day 43 (during Cycle 2) and at 1, 3, and 6 months post-treatment.|Cycle 1 Day 1, Cycle 1 Day 8, and Cycle 4 Day 1|"PK Population. Only those participants available at the indicated time points were assessed. The number of participants assessed at each time point is indicated by n=X,X."||Liters||Geometric Coefficient of Variation|Geometric Mean
774501|NCT00748657|Secondary|Progression-free Survival|Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.|Every other cycle for 6 months; then every 3 months for two years; then every six months for three years; and at any other time if clinically indicated based on symptoms, physical signs suggestive of progressive disease or rising serum tumor maker levels|Eligible and Treated Patients||Months||95% Confidence Interval|Median
774449|NCT00748189|Secondary|AUC(0-tau) of Ofatumumab|Area under the concentration time curve over the dosing interval [AUC(0-tau)] is a measure of drug exposure over time. AUC(0-tau) is defined as the area under the ofatumumab plasma concentration-time curve from dosing to time tau, where tau is the length of the dosing interval of ofatumumab. For estimation of AUC(0-tau), blood samples were collected from participants who received ofatumumab plus chlorambucil at pre-dose and 0.5 hous after the end of the ofatumumab infusion at treatment Cycle 1 and Cycle 4 (Days 1, 8, and 85). In addition, pre-dose samples were collected prior to the ofatumumab administration at Cycles 2, 3, 5, 6, 9 and 12 (Days 29, 57, 113, 141, 225 and 309), depending on duration of treatment. Samples were also collected during clinic visits on Day 15 (during Cycle 1) and Day 43 (during Cycle 2) and at 1, 3, and 6 months post-treatment.|Cycle 1 Day 1, Cycle 1 Day 8, and Cycle 4 Day 1|"PK Population. Only those participants available at the indicated time points were assessed. The number of participants assessed at each time point is indicated by n=X,X."||µg x hours/mL||Geometric Coefficient of Variation|Geometric Mean
774450|NCT00748189|Secondary|Total Plasma Clearance (CL) of Ofatumumab|Plasma clearance is defined as the plasma volume which is totally cleared of drug per unit of time. Blood samples were collected from participants who received ofatumumab plus chlorambucil at pre-dose and 0.5 hours after the end of the ofatumumab infusion at treatment Cycle 1 and Cycle 4 (Days 1, 8, and 85). In addition, pre-dose samples were collected prior to the ofatumumab administration at Cycles 2, 3, 5, 6, 9 and 12 (Days 29, 57, 113, 141, 225 and 309), depending on duration of treatment. Samples were also collected during clinic visits on Day 15 (during Cycle 1) and Day 43 (during Cycle 2) and at 1, 3, and 6 months post-treatment.|Cycle 4 Day 1|PK Population.||Milliliter/hour (mL/h)||Geometric Coefficient of Variation|Geometric Mean
774451|NCT00748189|Secondary|Cmax and Ctrough of Ofatumumab|Blood samples were collected to assess the plasma concentration of ofatumumab. Maximum concentration (Cmax) and observed drug concentration prior to the next dose (Ctrough) were determined. Blood samples were collected from participants who received ofatumumab plus chlorambucil at pre-dose and 0.5 hours after the end of the ofatumumab infusion at treatment Cycle 1 and Cycle 4 (Days 1, 8, and 85). In addition, pre-dose samples were collected prior to ofatumumab administration at Cycles 2, 3, 5, 6, 9 and 12 (Days 29, 57, 113, 141, 225 and 309), depending on the duration of treatment.|Cycle 1 Day 1,Cycle 1 Day 8, Cycle 2 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1, and Cycle 9 Day 1|Pharmacokinetic (PK) Population: all participants for whom a pharmacokinetic sample was obtained and analyzed.||Micrograms/Milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
774452|NCT00748189|Secondary|Number of Participants With a Human Anti-human Antibody (HAHA) Positive Result|Serum samples for analysis of HAHA were collected at Baseline (Screening), Cycle 4 Day 1 (after 3 months of treatment), and at 1 month and 6 months post last dose of ofatumumab. All samples were first tested in a screening step; positive samples from the screening were further evaluated in a confirmation test. The confirmed positive samples were reported as HAHA-positive and further evaluated in the titration test to obtain a titer of HAHA.|Baseline, Cycle 4 Day 1, 1 Month Follow-up, and 6 Month Follow-up|Safety population: all participants who received at least 1 dose of a study drug. Only participants with post-ofatumumab HAHA Results are included.||Participants|||Number
774453|NCT00748189|Secondary|Number of Participants With Improvement in Constitutional Symptoms (CS)|Assessment for the presence of the following symptoms were performed at Screening, Day 1 of each treatment cycle and at every Follow-up visit: night sweats (without signs of infection); unexplained, unintentional weight loss >= 10% within the previous 6 months; recurrent, unexplained fever of greater than 38 degrees celsius or 100.5 degrees fahrenheit for 2 weeks; and extreme fatigue. The best response refers to overall best response in terms of CR, CRi, PR or nPR. Data are presented for constitutional response= yes and no.|Baseline, Cycle 3 Day 1, and 1 month Follow-up|ITT population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||Participants|||Number
774454|NCT00748189|Secondary|Number of Participants With Improvement in ECOG Performance Status of 0 or 1, as Assessed by the IRC|The ECOG performance status scales and criteria are used by doctors and researchers to assess how a participant's disease is progressing, how the disease affects the daily living, and determines appropriate treatment and prognosis. Grade 0, fully active, able to carry on all pre-disease performance without restriction. Grade 1, restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. Grade 2, ambulatory and capable of all selfcare, but unable to carry out any work activities; up and about more than 50% of waking hours. Grade 3, capable of only limited selfcare; confined to bed or chair more than 50% of waking hours. Grade 4, completely disabled; cannot carry on any selfcare; totally confined to bed or chair. Grade 5, dead. Participants with an ECOG performance status of 0 or 1 are shown..|Baseline, Cycle 3 Day 1, 1 month Follow-up|ITT population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||Participants|||Number
774455|NCT00748189|Secondary|Time to Next Therapy|Time to next therapy is defined as the time from randomization until the start of the next-line of treatment.|From randomization until the 259th PFS event occurred (Median follow-up approximately 29.3 months)|ITT population. Only those participants with data available at the indicated time points were analyzed.||Months||95% Confidence Interval|Median
774456|NCT00748189|Secondary|Time to Progression, as Assessed by the IRC|Time to progression is defined as the time from the date of randomization to disease progression (PD). PD requires at least one of the following: lymphadenopathy, appearance of any new lesion such as enlarged lymph nodes (>1.5 cm) spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site; an increase by 50% or more in the previously noted enlargement of the liver or spleen, an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter, transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukaemia. Participants who were alive and had not progressed at the time of analysis or if a progression event occurred after extensive lost-to-follow-up time were censored at the date of the last visit with adequate assessment.|From randomization until the 259th PFS event occurred (Median follow-up approximately 29.3 months)|ITT population. Only those participants with data available at the indicated time points were analyzed.||Months||95% Confidence Interval|Median
774457|NCT00748189|Secondary|Duration of Response (DOR), as Assessed by the IRC|DOR is defined as the time from the initial response (CR, CRi, nPR, or PR) to the first documented sign of PD or death due to any cause. PD requires at least one of the following: lymphadenopathy, appearance of any new lesion such as enlarged lymph nodes (>1.5 cm) spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site; an increase by 50% or more in the previously noted enlargement of the liver or spleen, an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter, transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukaemia. Par. who were alive and had not progressed at the time of analysis or if a progression event occurred after extensive lost-to-follow-up time (>= 12 weeks) were censored at the date of the last visit with adequate assessment. Par. with unknown or missing responses were considered as non-responders.|From randomization until the 259th PFS event occurred (Median follow-up approximately 29.3 months)|ITT population. Only those participants with data available at the indicated time points were analyzed. Only responders (CR, CRi, PR, nPR) were included in the analysis.||Months||95% Confidence Interval|Median
774458|NCT00748189|Secondary|Time to Response, as Assessed by the IRC|Time to response is defined as the time from randomization to the first response (CR, CRi, nPR, or PR). CR (all the criteria at least 2 months after last treatment): no lymphadenopathy (Ly) > 1.5 cm/ hepatomegaly/ splenomegaly/ constitutional symptoms; neutrophils >1500 per microliter (µL), platelets (PL) >100,000/µL, hemoglobin (Hb) >11 grams/deciliter (g/dL), lymphocytes (LC) <4000/µL, bone marrow (BM) sample must be normocellular for age, <30% LC, no lymphoid nodule. CRi: CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to CLL but related to drug toxicity. PR: >=50% decrease in LC, Ly, size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline (BL), Hb >11 g/dL or 50% improvement over BL. nPR: persistent nodules BM. Participants with unknown or missing responses were considered as non-responders. Only responders (CR, CRi, PR, nPR) were included in the analysis.|From randomization until the 259th PFS event occurred (Median follow-up approximately 29.3 months)|ITT population. Time to response was measured using the International Workshop for CLL (IWCLL) updated National Cancer Institute-sponsored Working Group (NCI-WG) guidelines 2008.||Months||95% Confidence Interval|Median
774459|NCT00748189|Secondary|Overall Survival|Overall survival is defined as the time from randomization to death due to any cause. Each participant was followed at the time when the total IRC-assessed PFS events occurred. Participants who had not died were censored at the date of last contact.|From randomization until the 259th PFS event occurred (Median follow-up approximately 29.3 months)|ITT population. Only those participants with data available at the indicated time points were analyzed.||Months||95% Confidence Interval|Median
774460|NCT00748189|Secondary|Number of Participants Who Were Negative for Minimal Residual Disease (MRD)|MRD was performed by flow cytometry on a bone marrow or peripheral blood sample taken at least 2 months after final treatment. MRD negative was defined as less than one CLL cell per 10000 leukocytes.|From randomization until the 259th PFS event occurred (Median follow-up approximately 29.3 months)|ITT population. Only those participants with data available at the indicated time points were analyzed.||Participants|||Number
774461|NCT00748189|Secondary|Number of Participants With the Best Overall Response (OR), as Assessed by the IRC|OR is defined as the number of participants achieving an objective response (complete response [CR], CR with incomplete bone marrow recovery [CRi], partial response [PR], and nodular PR [nPR]). CR (all the criteria at least 2 months after last treatment): no lymphadenopathy (Ly) > 1.5 cm/ hepatomegaly/ splenomegaly/ constitutional symptoms; neutrophils >1500 per microliter (µL), platelets (PL) >100,000/µL, hemoglobin (Hb) >11 grams/deciliter (g/dL), lymphocytes (LC) <4000/µL, bone marrow (BM) sample must be normocellular for age, <30% LC, no lymphoid nodule. CRi: CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to CLL but related to drug toxicity. PR: >=50% decrease in LC, Ly, size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline (BL), Hb >11 g/dL or 50% improvement over BL. nPR: persistent nodules BM.|From randomization until the 259th PFS event occurred (Median follow-up approximately 29.3 months)|ITT population. Only those participants with data available at the indicated time points were analyzed. OR was according to the International Workshop for Chronic Lymphocytic Leukemia (IWCLL) updated National Cancer Institute-sponsored Working Group (NCI-WG) guidelines. The 95% exact binomial confidence interval is for CR+CRi+nPR+PR.||Participants|||Number
774462|NCT00748189|Primary|Progression-Free Survival (PFS), as Assessed by the Independent Review Committee (IRC)|PFS is defined as the interval of time between the date of randomization and the earlier of the date of disease progression (PD) and the date of death due to any cause. PD requires at least one of the following: lymphadenopathy, appearance of any new lesion such as enlarged lymph nodes (>1.5 cm) spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site; an increase by 50% or more in the previously noted enlargement of the liver or spleen, an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter, transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukaemia. Par. who were alive and had not progressed at the time of analysis or if a progression event or death occurred after extensive lost-to-follow-up time or if new anti-cancer therapy was started were censored at the date of the last visit with adequate assessment.|From randomization until the 259th PFS event occurred (Median follow-up approximately 29.3 months)|Intent-to-Treat (ITT) Population: all par. randomized to study treatment regardless of whether or not they received treatment. PFS was assessed by a blinded independent review committee according to the International Workshop for Chronic Lymphocytic Leukemia (IWCLL) updated National Cancer Institute-sponsored Working Group (NCI-WG) guidelines.||Months||95% Confidence Interval|Median
774463|NCT00748241|Secondary|Implant Failure|Total number of implants reported as failure.|3 years after implant placement|Number of failed implants based on total number of patients enrolled and total number of placed implants||Number of implants|Participants||Number
774464|NCT00748241|Primary|Implant Survival Rate|An implant that has failed to osseointegrate, lost its osseointegration or fractured will be considered a failure effective from the date of removal. Implant Survival Rate will be calculated using the Kaplan-Meyer method based on the number of placed implants. Patients who discontinued the study after the last implant failure do not affect the cumulative survival rate.|At follow-up visit: 3 years after implants have been loaded|Population includes subjects who completed 36 month visit.||Percentage of implants|Participants||Number
774466|NCT00748241|Primary|Implant Survival Rate|An implant that has failed to osseointegrate, lost its osseointegration or fractured will be considered a failure effective from the date of removal. Implant Survival Rate will be calculated using the Kaplan-Meyer method based on the number of placed implants. Patients who discontinued the study after the last implant failure do not affect the cumulative survival rate.|At follow-up visit: 1 year after implants have been loaded|Population includes subjects who completed 12 month visit.||Percentage of implants|Participants||Number
774467|NCT00748241|Primary|Implant Survival Rate|An implant that has failed to osseointegrate, lost its osseointegration or fractured will be considered a failure effective from the date of removal. Implant Survival Rate will be calculated using the Kaplan-Meier method based on the number of placed implants. Patients who discontinued the study after the last implant failure do not affect the cumulative survival rate.|At follow-up visit: 6 months after implants have been loaded|Population includes subjects who completed the 6 month visit (2 subjects missed the 6 month visit but completed the 1 year visit).||Percentage of implants|Participants||Number
774468|NCT00748553|Secondary|Progression-free Survival|Progression-free survival (PSF) is defined as the length of time during and after treatment in which a patient is living with a disease that does not get worse.|2 years|Data were not collected.|||||
774469|NCT00748553|Secondary|Number of Participants With ER+ Status|Tissue SPARC protein will be assessed using archival tumor blocks. In addition, in patients who have easily accessible tumors, such as lymph nodes, cutaneous or subcutaneous lesions, and who have consented to sample collection, biopsies will be taken twice: before cycle 1 day 1 treatment, and cycle 3 day 8 (+/- 3 days).|2 years|Of the 14 patients enrolled on the Phase II portion of trial, one patient opted out off trial after 1 cycle because of toxicity. Thirteen patients were evaluated for ER+ status.||participants were ER+|||Number
774470|NCT00748553|Primary|Phase II: Percentage of Participants With Objective Response Rate (ORR) Measured Using RECIST 1.0 Criteria|"Objective response rate (ORR) will be measured using RECIST 1.0 criteria. The best response, including complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD), for each patient will be summarized.
For target lesions, Complete Response is defined as disappearance of all target lesions for at least 4 weeks; Partial Response consists of at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD, for at least 4 weeks; Progressive Disease consists of at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease consists of neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started."|1.5 years|Of the 14 patients enrolled on the Phase II portion of trial, one patient opted out off trial after 1 cycle because of toxicity.||percentage of participants||95% Confidence Interval|Number
774471|NCT00748553|Primary|Phase I: Percentage of Participants Responding to Treatment|Azacitidine is set at 75mg/m2 and Nab-paclitaxel is set at100mg/m2 based on the number of participants responding to treatment as measured per RECIST v1 criteria.|6 months|16 patients were evaluable for toxicity. 13 were evaluable for response per RECIST v1.||percent of participants with response||95% Confidence Interval|Number
774472|NCT00748566|Secondary|Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Score at Week 1, 2, 4, 8, 12, 20, 28, 36, 44 and 52|C-SSRS assessed whether participant experienced following: completed suicide(1), suicide attempt(2) (response of “Yes” on “actual attempt”), preparatory acts toward imminent suicidal behavior(3)(“Yes” on “preparatory acts or behavior”), suicidal ideation(4) (“Yes” on “wish to be dead”, “non-specific active suicidal thoughts”, “active suicidal ideation with methods without intent to act/some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior(7)(“Yes” on “Has subject engaged in non-suicidal self-injurious behavior”).|Baseline, Week 1, 2, 4, 8, 12, 20, 28, 36, 44 and 52|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis.|||||
774473|NCT00748566|Secondary|Changes From Baseline in European Quality of Life (EuroQoL) – 5 Dimensions Visual Analog Scale (VAS) Score at Week 28 and 52|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Week 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable for this measure at specified time points.||units on a scale||Standard Deviation|Mean
774474|NCT00748566|Secondary|Change From Baseline in European Quality of Life (EuroQoL) – 5 Dimensions Index (EQ-I) Score at Week 28 and 52|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Baseline, Week 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
774475|NCT00748566|Secondary|Change From Baseline in Social and Occupational Functioning Assessment Scale (SOFAS) Score at Week 28 and 52|SOFAS: a 0-100 single score scale focusing exclusively on participant's level of social and occupational functioning; not directly influenced by overall severity of participant's psychological symptoms; higher score = higher level of functioning.|Baseline, Week 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
774502|NCT00748657|Primary|Tumor Response|Complete and Partial Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0|Every other cycle for 6 months; then every 3 months for two years; then every six months for three years; and at any other time if clinically indicated based on symptoms, physical signs suggestive of progressive disease or rising serum tumor maker levels|Eligible and Treated Patients||percentage of patients||90% Confidence Interval|Number
774476|NCT00748566|Secondary|Change From Baseline in Drug-Attitude Inventory–30-Item Scale (DAI-30) Score at Week 28 and 52|DAI, a 30-item scale measuring subjective responses to medication (including acceptability and tolerability which aims to understand the factors influencing treatment adherence). Scale has 15 items (statements) scored as true and 15 items scored as false. An overall calculated score ranged from -15 to 15, where a positive score indicated a positive subjective response (compliant), a negative score indicated non-compliance.|Baseline, Week 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable for this measure at specified time points.||units on a scale||Standard Deviation|Mean
774477|NCT00748566|Secondary|Clinical Global Impression-Improvement (CGI-I) Scale Score|CGI-I is a single-item, clinician-rated scale that assesses global improvement in the participants clinical state in response to study treatment, and as compared to their status at pre-treatment baseline. Possible CGI-I scores range from 1 to 7, where 1=very much improved, 4=no change and 7=very much worse.|Endpoint (premature discontinuation or Week 52)|PP population. Missing values at Week 52 were imputed using LOCF. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
774478|NCT00748566|Secondary|Change From Baseline in Clinical Global Impression-Severity Scale (CGI-S) Score at Week 12, 28 and 52|CGI-S is a single-item, clinician-rated scale that assesses the global severity of the participants overall illness. CGI-S ratings range from 1 (normal, not at all ill) to 7 (among the most severely ill participants).|Baseline, Week 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable for this measure at specified time points.||units on a scale||Standard Deviation|Mean
774479|NCT00748566|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score, Positive and Negative Subscale Scores at Week 12, 28 and 52|Assesses positive and negative symptoms, general psychopathology specifically associated with schizophrenia. Scale consists of 30 items, each rated on scale from 1 (symptom not present) - 7 (symptoms extremely severe). Sum of 30 items is defined as PANSS total score, range:30-210. 7 items make up positive scale (delusions, conceptual disorganization, hallucinatory behavior); total range: 7-49. 7 items make up negative scale (blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal); total range: 7-49. For each subscale, total score: higher score=greater severity.|Baseline, Week 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable for this measure at specified time points.||units on a scale||Standard Deviation|Mean
774480|NCT00748566|Secondary|Change From Baseline in QT Interval Corrected for Heart Rate (QTc) at Week 4, 12, 28 and 52|QT interval is the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTc is the QT interval corrected for heart rate. Corrected QT interval using Fridericia's heart rate correction formula: QTcF = QT/RR^1/3, where RR=RR interval in seconds (60 divided by heart rate).|Baseline, Week 4, 12, 28, 52|Intent-to-treat (ITT) population included all enrolled participants who received at least 1 dose of study medication, had baseline and at least 1 post-baseline MS measure. Missing values at Week 52 were imputed using LOCF. N (number of participants analyzed)=participants evaluable for this measure. n=evaluable participants at specified time points.||milliseconds||Standard Deviation|Mean
774481|NCT00748566|Secondary|Change From Baseline in the Physical Activity Index Score at Week 28 and 52|Physical activity (exercise) score derived for each participant based on the frequency and intensity of physical activities: regular walking, recreational activity, cycling, and sporting activity. Six categories of total score: inactive (range: 0-2), occasional (range: 3-5), light (range: 6-8), moderate (range: 9-12), moderately vigorous (range: 13-20), and vigorous (>=21). Higher total score = higher frequency and intensity of physical activity.|Baseline, Week 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
774482|NCT00748566|Secondary|Change From Baseline in Insulin Level at Week 4, 12, 28 and 52||Baseline, Week 4, 12, 28, 52|PP population. Missing values were imputed using LOCF at Week 52. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable for this measure at specified time points.||international unit per liter (IU/L)||Standard Deviation|Mean
774483|NCT00748566|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) Concentration at Week 4, 12, 28 and 52|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time.|Baseline, Week 4, 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.||percentage of total hemoglobin||Standard Deviation|Mean
774484|NCT00748566|Secondary|Change From Baseline in Body Mass Index (BMI) at Week 4, 12, 28 and 52|Body mass index calculated as weight in kilograms (kg) divided by height in (meters) squared (m)^2 .|Baseline, Week 4, 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.||kg/m^2||Standard Deviation|Mean
774485|NCT00748566|Secondary|Change From Baseline in Weight at Week 4,12, 28 and 52||Baseline, Week 4, 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.||kilogram (kg)||Standard Deviation|Mean
774486|NCT00748566|Secondary|Change From Baseline in Total Cholesterol (TC) and Low Density Lipoprotein-Cholesterol (LDL-C) Levels at Week 4, 12, 28 and 52||Baseline, Week 4, 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.||mmol/L||Standard Deviation|Mean
774503|NCT00748709|Secondary|Number of Patients With Diarrhea or Rash|Number of Patients with Diarrhea or Rash|First administration of trial medication until 28 days after last administration of trial medication|TS||Participants|||Number
774504|NCT00748709|Secondary|Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 15 (Cpre,ss,15) for Patients on 50mg on Day 15|Cpre,ss,15 represents the pre-dose concentration of afatinib in plasma at steady state on day 15 for patients on 50mg on day 15.|Day 15|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
774487|NCT00748566|Secondary|Change From Baseline in 10-year Cardiovascular Heart Disease (CHD) Risk According to Framingham Scoring System at Week 4, 12, 28 and 52|Framingham scoring system risk factors: age (risk points range: -9 to 16), cholesterol (risk points range: 0 to 13), HDL cholesterol (risk points range: -1 to 2), smoking (risk points range: 0 to 9), and systolic blood pressure (risk points range: 0 to 6); total risk points range <0 to >=25, higher score indicates higher CHD risk. The risk points are transformed to 10-year risk percentage for CHD which ranges from <1% to >=30%, where higher percent indicates greater risk for CHD.|Baseline, Week 4, 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable for this measure at specified time points.||percent of 10-year CHD risk||Standard Deviation|Mean
774488|NCT00748566|Secondary|Change From Baseline in Fasting Glucose Level at Week 4, 12, 28 and 52||Baseline, Week 4, 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.||mg/dL||Standard Deviation|Mean
774489|NCT00748566|Secondary|Change From Baseline in Triglyceride and High Density Lipoprotein-Cholesterol (HDL-C) Levels at Week 4, 12, 28 and 52|Triglyceride data is reported for whole study population whereas HDL-C data is reported separately for male and female participants.|Baseline, Week 4, 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.||mg/dL||Standard Deviation|Mean
774490|NCT00748566|Secondary|Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Week 4, 12, 28 and 52|BP measurement is recorded as systolic BP (SBP, BP when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle) and diastolic BP (DBP, BP when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles).|Baseline, Week 4, 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.||mmHg||Standard Deviation|Mean
774491|NCT00748566|Secondary|Change From Baseline in Waist Circumference at Week 4, 12, 28 and 52|Waist circumference data is reported separately for male and female participants.|Baseline, Week 4, 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.||cm||Standard Deviation|Mean
774492|NCT00748566|Secondary|Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS)|MS risks factors: elevated waist circumference: >=102 cm in men, >=88 cm in women (Asian origin: >=90 cm [men], >=80 cm [women]); elevated triglycerides: >=1.7 mmol/L (>=150 mg/dL); reduced high-density lipoprotein cholesterol (HDL-C): <1.03 mmol/L (<40 mg/dL) in men, <1.3 mmol/L (<50 mg/dL) in women; elevated fasting glucose: >=5.6 mmol/L (>=100 mg/dL); elevated SBP/DBP: SBP >=130 mmHg and/or DBP >=85 mmHg.|Baseline, Week 4, 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.||percentage of participants||95% Confidence Interval|Number
774493|NCT00748566|Secondary|Number of Participants With Change From Baseline in Metabolic Syndrome (MS) Risk Factors at Week 4, 12, 28 and 52|MS risks factors: elevated waist circumference: >=102 cm in men, >=88 cm in women (Asian origin: >=90 cm [men], >=80 cm [women]); elevated triglycerides: >=1.7 mmol/L (>=150 mg/dL); reduced high-density lipoprotein cholesterol (HDL-C): <1.03 mmol/L (<40 mg/dL) in men, <1.3 mmol/L (<50 mg/dL) in women; elevated fasting glucose: >=5.6 mmol/L (>=100 mg/dL); elevated SBP/DBP: SBP >=130 mmHg and/or DBP >=85 mmHg.|Week 4, 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.||participants|||Number
774494|NCT00748566|Secondary|Percentage of Participants With Metabolic Syndrome (MS)|According to the National Cholesterol Education Program (NCEP) Adult Treatment Panel III (ATPIII), metabolic syndrome is defined as a condition that includes 3 or more of 5 characteristics: abdominal obesity, hypertriglyceridemia, low high-density lipoprotein (HDL) cholesterol, high blood pressure, and high fasting glucose.|Baseline, Week 4, 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.||percentage of participants||95% Confidence Interval|Number
774495|NCT00748566|Secondary|Mean Change From Baseline in the Number of Risk Factors of Metabolic Syndrome (MS) at Week 4, 12, 28 and 52|MS risks factors: elevated waist circumference: greater than or equal to (>=)102 cm in men, >=88 cm in women (Asian origin: >=90 cm [men], >=80 cm [women]); elevated triglycerides: >=1.7 mmol/L (>=150 mg/dL); reduced high-density lipoprotein cholesterol (HDL-C): less than (<)1.03 mmol/L (<40 mg/dL) in men, <1.3 mmol/L (<50 mg/dL) in women; elevated fasting glucose: >=5.6 mmol/L (>=100 mg/dL); elevated SBP/DBP: SBP >=130 mmHg and/or DBP >=85 mmHg.|Baseline, Week 4, 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.||risk factors||Standard Deviation|Mean
774496|NCT00748566|Primary|Percentage of Participants Achieving at Least 1 Risk Factor Reduction From Baseline for Metabolic Syndrome (MS)|MS risks factors: elevated (el) waist, men:>=102 centimeters(cm), women:>=88 cm (Asian origin:>=90 cm in men, >=80 cm in women); el triglycerides: >=1.7 millimoles per liter (mmol/L) (>=150 milligram per deciliter [mg/dL]); reduced high-density lipoprotein cholesterol (HDL-C), men:<1.03 mmol/L (<40 mg/dL), women:<1.3 mmol/L (<50 mg/dL); el fasting glucose: >=5.6 mmol/L (>=100 mg/dL); el systolic/diastolic blood pressure (SBP/DBP): SBP>=130 millimeters of mercury (mmHg) and/or DBP>=85 mmHg. Responder=at least 1 less risk factor at endpoint (premature discontinuation or Week 52) than baseline.|Endpoint (premature discontinuation or Week 52)|Per protocol (PP) population included all enrolled participants who received at least 1 dose of study medication, had baseline and at least 1 post-baseline MS measure, and remained in the study for at least 16 weeks. Missing values were imputed using last observation carried forward (LOCF).||percentage of participants||95% Confidence Interval|Number
774497|NCT00748579|Secondary|Effects of CK-1827452 on Ventricular Performance, Myocardial Oxygen Consumption, Pressure-volume Relationships, Systolic Ejection Time and Invasively Measured Hemodynamics, Including Filling Pressures and Cardiac Output.||1 day||||||
774498|NCT00748579|Primary|Effect of CK-1827452 on Myocardial Efficiency, Defined as the Ratio of Ventricular Performance to Myocardial Oxygen Consumption.|Measure the effect CK-1827452 on hemodynamics and energetic measures of ventricular performance, myocardial oxygen consumption, and myocardial efficiency (the ratio of ventricular performance to myocardial oxygen consumption), in patients with clinical heart failure.|1 day|Study was terminated due to poor enrollment; 2 participants completed the study. Data quantity was insufficient to analyze or draw conclusions.|||||
774505|NCT00748709|Primary|Percentage of Participants With Objective Response (OR)|OR is defined as the percentage of patients with complete response (CR) or partial response (PR) and was assessed according to the Response Evaluation Criteria in Solid Tumours version 1.0 (RECIST 1.0).|Tumour assessments were performed at screening, week 6, week 12, and every 8 weeks thereafter|Treated Set (TS). TS consisted of all patients who received at least one dose of trial medication.||percentage of patients|||Number
774506|NCT00748709|Secondary|Maximum CTCAE Grade|Patients with AEs by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade|First administration of trial medication until 28 days after last administration of trial medication|TS||Participants|||Number
774507|NCT00748709|Secondary|Patients With AEs Resulting in Dose Reduction or Treatment Discontinuation|Patients with adverse events (AEs) resulting in dose reduction or treatment discontinuation|First administration of trial medication until 28 days after last administration of trial medication|TS||Participants|||Number
774508|NCT00748709|Secondary|Progression-free Survival (PFS)|PFS was defined as the time from the start of treatment to the occurrence of disease progression or death, whichever came first. Disease progression was assessed according to RECIST 1.0 criteria as well as by the investigators assessment, progression date recorded from post trial follow up or start of new anticancer treatment.|Tumour assessments were performed at screening, week 6, week 12, and every 8 weeks till database lock.|Trial terminated early, therefore no data summaries produced for PFS.|||||
774509|NCT00748709|Secondary|Duration of OR|Duration of OR was measured from the time the criteria for CR or PR (whichever was documented first) were first met until the first date that progressive disease or death was objectively documented.|Tumour assessments were performed at screening, week 6, week 12, and every 8 weeks till database lock.|Trial terminated early, therefore no data summaries produced for duration of OR.|||||
774510|NCT00748709|Secondary|Time to Objective Response (OR)|The time to OR was the duration from the first treatment to the time when the measurement criteria for CR and/or PR were met according to RECIST 1.0 criteria.|Tumour assessments were performed at screening, week 6, week 12, and every 8 weeks till database lock|Trial terminated early, therefore no data summaries produced for time to OR.|||||
774511|NCT00748709|Secondary|Percentage of Participants With Clinical Benefit (CB)|CB was defined as CR, PR or stable disease (SD) and was assessed according to RECIST 1.0 criteria.|Tumour assessments were performed at screening, week 6, week 12, and every 8 weeks till database lock|TS.||percentage of patients|||Number
774512|NCT00748826|Primary|Number of Participants Who Had a Chest X-ray as Part of TB Screening for Active or Latent Tuberculosis Before Starting Treatment|"In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). If done according to guidelines, complete TB screening comprised of a TB screening test and a chest X-ray. The number of participants who had a frontal chest X-ray was presented in three categories:
Yes
Missing"|Baseline|Of 576 participants enrolled on study (508 with rheumatoid arthritis and 68 with psoriatic arthritis), only data from the 508 rheumatoid arthritis participants was evaluated.||participant|||Number
774513|NCT00748826|Primary|Number of Participants Who Had the In-vitro TB Test as the First Screening Test for Active or Latent Tuberculosis Before Starting Treatment|"In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). The number of participants who had the In-vitro TB test (cellular blood test, i.e. gamma interferon release assays) per clinical testing as the first screening test was presented in three categories:
Yes
Missing"|Baseline|Of 576 participants enrolled on study (508 with rheumatoid arthritis and 68 with psoriatic arthritis), only data from the 508 rheumatoid arthritis participants was evaluated.||participants|||Number
774514|NCT00748826|Primary|Number of Participants Who Had the Tine Test as the First Screening Test for Active or Latent Tuberculosis Before Starting Treatment|"In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). The number of participants who had the Tine test (Multiple puncture Tuberculin skin test) per clinical testing as the first screening test was presented in three categories:
Yes
Missing"|Baseline|Of 576 participants enrolled on study (508 with rheumatoid arthritis and 68 with psoriatic arthritis), only data from the 508 rheumatoid arthritis participants was evaluated.||participants|||Number
774515|NCT00748826|Primary|Number of Participants Who Had the Mendel Mantoux Test as the First Screening Test for Active or Latent Tuberculosis (TB) Before Starting Treatment|"In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). The number of participants who had the Mendel Mantoux test (Tuberculin sensitivity skin test by intradermal injection) per clinical testing as the first screening test was presented in
three categories:
Yes
Missing"|Baseline|Of 576 participants enrolled on study (508 with rheumatoid arthritis and 68 with psoriatic arthritis), only data from the 508 rheumatoid arthritis participants was evaluated.||participants|||Number
774516|NCT00748865|Primary|Drop Comfort|Drop comfort grading scale is a 0 to 9 scale, with 0 meaning most comfortable and 9 meaning most uncomfortable,|once upon instillation|||Units on a scale||Standard Deviation|Median
774517|NCT00748956|Secondary|Profile of Mood States (POMS)|measure in 2 hours post intranasal administration and on the next morning|on study day 2|data not collected|||||
774518|NCT00748956|Secondary|Quick Inventory of Depressive Symptoms (QIDS)|measure in 2 hours post intranasal administration|on study day 2|data not collected|||||
774519|NCT00748956|Secondary|Post-sleep Questionnaire|measure in the morning|on study day 2|data not collected|||||
774520|NCT00748956|Secondary|Appetite Scale|measure in 2 hours post intranasal administration|on study day 2|data not collected|||||
774521|NCT00748956|Secondary|Systematic Assessment of Treatment-Emergent Effects (SAFTEE)|Number of participants with serious adverse events|on study day 2|||Participants|||Count of Participants
774522|NCT00748956|Primary|Levels of NPY in CSF|Levels of Neuropeptide Y in the cerebrospinal fluid|on study day 2|||pg/mL||Standard Deviation|Mean
774523|NCT00748969|Secondary|Change in Neuropsychological Functioning and Brain Volumetrics.||12 months||||||
774524|NCT00748969|Secondary|Change in Muscle Strength Measured by Biodex and Hand Grip Dynamometer.||12 months||||||
774527|NCT00748969|Secondary|Safety of Nutropin AQ® in Children With MPS I, II, and VI. Safety Endpoints Are: • Physical Examinations • Fundoscopic Examinations • Adverse Events • Radiographic Examinations of Spine and Lower Extremities|"Three days after starting treatment with Nutropin AQ the subjects mother reported that the study subject developed headache, increased noisy and more labored breathing (history of obstructive sleep apnea treated with BIPAP), and fatigue with watery eyes. Symptoms resolved with discontinuation of Nutropin AQ and before evaluation by physician. Subject withdrew from the study due to these adverse effects."|1 months||||||
774528|NCT00748969|Primary|Change in Growth Velocity From Baseline to End of Study Year 1.||12 months|"Zero participants analyzed in the No growth hormone treatment group due to subject withdrew from study as soon as informed they were assigned the no treatment group."||cm/yr|||Number
774529|NCT00748982|Secondary|QTcF Interval|Maximum QTcF observed for each patient. QTcF is the QT interval corrected for the RR interval using the Fridericia formula|Up to 24 hours following start of IV dosing.|||ms||95% Confidence Interval|Mean
774530|NCT00748982|Secondary|Area Under Curve (AUC) ( µmol*h/L) of AZD1305|To evaluate the pharmacokinetics of AZD1305, given as an iv infusion, in patients with left ventricular dysfunction|From the iv loading dose during 30 min and the following maintenance iv dose during a maximum of 90 min.|||µmol*h/L||Full Range|Mean
774531|NCT00748982|Secondary|Number of Subjects With at Least One Reported Adverse Event During Each Study Period and in Each Dose Group|To evaluate the tolerability and safety of AZD1305 given as an iv infusion to patients with left ventricular dysfunction.|From randomisation to last study visit (mean infusion time 1.6 hours)|||Participants|||Number
774532|NCT00748982|Primary|Left Ventricular Ejection Fraction (LVEF), Change From Baseline|To explore if AZD1305 compromises left ventricular performance in patients with left ventricular dysfunction.|From the iv loading dose during 30 min and the following maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out|||Percent change||95% Confidence Interval|Mean
774533|NCT00749073|Primary|Quality of Life as Measured by the PCS Subscale of the Short-form 12 Question (SF-12) Survey.|The 12-question SF-12v2 Health Survey is a validated generic measure of health status & outcomes, as opposed to one that targets a specific age, disease, or treatment group. The Physical Component Summary (PCS)takes into account the correlations among the Physical Functioning (PF), Role Physical (RP), Bodily Pain (BP), General Health (GH), and Vitality (VT)SF-12v2 Health Survey scales to show the broad impact on PCS. Norm-based scoring is used so each scale has the same mean (50 points) and the same standard deviation (10 points) as the general US population in 1998. Scores below 50 indicate a decline in health status, with lower scores representing worse health status. Minimally Important Difference (MID) is a measure of true clinical relevance of a difference, with suggested MID for the Physical Component Summary (PCS) being 2 to 3 points. Change from baseline to 6 months is presented, where a positive value represents the 6 month value minus the baseline value.|Baseline and Six months|All available treated patients with six month follow-up.||units on a scale||95% Confidence Interval|Mean
774534|NCT00749073|Primary|Function as Measured Subjectively by the Oswestry Disability Index Patient Questionnaire|Oswestry Disability Index (ODI) is used to measure permanent functional disability through a series of questions which characterize the disturbance of activities of daily living resulting from chronic back pain. The questionnaire is divided into 10 topics including pain intensity , personal care, lifting, walking, sitting, standing, sleeping, social life, traveling and employment/homemaking. Each topic is rated 0 (no pain or no limitation) to 5 (high pain or very limited physically). The worst possible score is 50 (100% disability) and best would be zero (0% disability), thus a higher ODI score indicates greater disability.|Baseline and Month 6|All treated patients having six month follow-up were included.||units on a scale||Standard Deviation|Mean
774535|NCT00749073|Primary|Changes in Back Pain as Measured by a 10-point Visual Analog Scale (VAS).|Clinical relevance established by change of two points or more on a ten point scale where zero represents no pain and ten represents worst pain imaginable. Mean change from baseline to Month 6 was reported with a positive number representing the baseline value minus the 6 month value.|Baseline and Six Months|All available treated patients at six months post treatment. Mean change from baseline to Month 6 was reported.||units on a scale||Standard Deviation|Mean
774536|NCT00749190|Secondary|Trough Concentrations of Empagliflozin in Plasma|(Pre-dose) trough concentrations of Empagliflozin in plasma, within 30 minutes of dosing.|Days 28, 56 and 84|All patients who received at least one dose of Empagliflozin and have some Pharmacokinetic (PK) data.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
774537|NCT00749190|Secondary|Change of Body Weight After 12 Weeks of Treatment|Results for change of body weight after 12 weeks of treatment based on ANCOVA.|Baseline and 12 weeks|FAS (CLOCF)||kg||Standard Error|Mean
774538|NCT00749190|Secondary|Change in Homeostasis Model Assessment Index for Beta Cell Function (HOMA-%B)|HOMA-%B (to assess insulin beta cell function) is defined as (20 x FPI)/(FPG-3.5), FPG in mg/dl. Results are based on ANCOVA.|Baseline and 12 weeks|FAS (CLOCF)||mU / mmol||Standard Error|Mean
774539|NCT00749190|Secondary|Change in Homeostasis Model Assessment Index for Insulin Resistance (HOMA-IR)|HOMA-IR (to assess insulin resistance) is defined as (FPI x FPG)/22.5. Results based on ANCOVA.|Baseline and 12 weeks|FAS (CLOCF)||mU/L x mmol/L||Standard Error|Mean
774540|NCT00749190|Secondary|Change From Baseline to Week 12 in Fasting Plasma Insulin (FPI)|Results for change of FPI from baseline at week 12 based on ANCOVA|Baseline and 12 weeks|FAS (CLOCF)||mU/L||Standard Error|Mean
774541|NCT00749190|Secondary|Proportion of Patients Who Achieve an HbA1c Lowering of at Least 0.5% After 12 Weeks of Treatment|Results for HbA1c categories at week 12 (Proportion of patients with HbA1c lowered at least 0.5%) based on logistic regression|Baseline and 12 weeks|FAS (CLOCF)||percentage of participants|||Number
774542|NCT00749190|Secondary|Proportion of Patients Who Achieve an HbA1c ≤7.0% After 12 Weeks of Treatment|Results for HbA1c categories at week 12 (Proportion of patients with HbA1c less than equal to 7%) based on logistic regression|Baseline and 12 weeks|FAS (CLOCF)||percentage of participants|||Number
774543|NCT00749190|Secondary|Change of HbA1c From Baseline Over Time|Change of HbA1c from baseline over time. Results presented stem from a repeated measures analysis.|Baseline and weeks 4, 8 and 12|FAS. Imputation method used was the classical LOCF (CLOCF) approach which uses always the last available value.||percentage of HbA1c||Standard Error|Mean
775856|NCT00754065|Secondary|Number of Spotting-only Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure||Episodes||Standard Deviation|Mean
774544|NCT00749190|Secondary|Change of FPG From Baseline After 12 Weeks of Treatment|"Change of Fasting Plasma Glucose (FPG) from baseline after 12 weeks of treatment. Results presented stem from a repeated measures analysis.
In the measured values adjusted means are displayed. For means for the placebo and empagliflozin arms are from the model excluding the sitagliptin open label (OL) arm. The mean for the sitagliptin OL arm is from the model with just this treatment group and the placebo group."|Baseline and 12 weeks|FAS using modified LOCF imputation method||mg/dL||Standard Error|Mean
774545|NCT00749190|Primary|Change From Baseline in HbA1c After 12 Weeks of Treatment|"Change from baseline in HbA1c after 12 weeks of treatment.
In the measured values adjusted means are displayed. For means for the placebo and empagliflozin arms are from the model excluding the sitagliptin open label (OL) arm. The mean for the sitagliptin OL arm is from the model with just this treatment group and the placebo group."|Baseline and 12 weeks|Full analysis set (FAS) consisting of all randomized patients who were treated with at least one dose of study drug and has a baseline measurement of the primary endpoint. The imputation method used was a modified last observation carried forward (LOCF) approach which used linear interpolation, LOCF and worst observation carried forward (WOCF).||percentage of HbA1c||Standard Error|Mean
774546|NCT00749268|Secondary|Hernia Recurrence||Discharge, 1 Month, 6 Month, 1 year|||participants|||Number
774547|NCT00749268|Secondary|Quality of Life|"Quality of life as measured by the SF-12 which is a multipurpose short form survey with 12 questions. The questions were combined, scored, and weighted to create a scale that provide glimpses into physical functioning and overall health-related-quality of life.
The Physical Composite Score was computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health."|Pre-op, Month 1, Month 6, 1 year|Participant # above reflects those at pre-op. Arms ended study with 34, 39, 36 and 39 subjects, respectively.||units on a scale||Standard Deviation|Mean
774548|NCT00749268|Primary|Safety for Laparoscopic Hernia Repair as Measured by Number of Patients Experiencing Device Related Events||One year|||participants|||Number
774549|NCT00749268|Primary|Postoperative Pain|"Pain Intensity Numeric Rating Scale (PI-NRS) - change from baseline. Treatments analyzed within inguinal arm and within ventral arm.
Scale is 0 - 10 with 0 being no pain and 10 being worst pain imaginable."|Discharge, Month 1, Month 6, Month 12|1 patient in the Ventral Arm - AbsorbaTack had only pre-operative pain scores available so was unable to be included in this analysis.||units on a scale||Standard Deviation|Mean
774550|NCT00749398|Secondary|Number of Participants With Satisfactory Health Status|"Participant's opinion on his/her health status, as assessed by the following question: Think about all the ways your psoriasis is affecting you, do you consider that your current status is satisfactory? (Yes/No)"|Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)|Per protocol analysis.||Participants|||Number
774551|NCT00749398|Secondary|Dermatology Life Quality Index (DLQI) Score|DLQI ranged from 0 (no effect on participant's life) to 30 (extremely large effect on participant's life) and was computed by summing the score (each ranging from 0 to 3) of each of a 10-item questionnaire.|Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)|Per protocol analysis.||Score on a scale||Standard Deviation|Mean
774552|NCT00749398|Secondary|Dynamic PGA Score as Assessed by the Participant|The dynamic PGA was scored twice, at the middle and at the end of the observation period. Clinical improvement from Baseline (Visit 1) was evaluated with a 10 cm-VAS ranging from 0 (no improvement) to 10 (disappearance of lesions) at the Week 14 (Visit 4) and Week 30 (Visit 6) visits.|Week 0 (Visit 1), Week 14 (Visit 4), Week 30 (Visit 6)|Per protocol analysis.||Score on a scale||Standard Deviation|Mean
774553|NCT00749398|Secondary|Static PGA Score as Assessed by the Participant|Participants assessed their psoriasis at Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), and Week 30 (Visit 6) according to the Static PGA score, which ranged from 0 (no psoriasis) to 5 (extreme psoriasis). The higher the number, the more severe the psoriasis was.|Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)|Per protocol analysis.||Score on a scale||Standard Deviation|Mean
774554|NCT00749398|Secondary|Nail Psoriasis Severity Index (NAPSI) Score|The nail was divided with imaginary horizontal and longitudinal lines into quadrants. Each nail was given a score for nail bed psoriasis (0-4) and nail matrix psoriasis (0-4) depending on the presence of any of the features of nail psoriasis in that quadrant. Each nail was evaluated, and the sum of all the nails was the total NAPSI score. The sum of the scores from all nails ranged from 0 (no psoriasis) to 80 (psoriasis present in all 4 quadrants of all 10 nails).|Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)|Per protocol analysis.||Score on a scale||Standard Deviation|Mean
774555|NCT00749398|Secondary|Psoriasis Area and Severity Index (PASI) Score|PASI ranged from 0 (no symptoms) to 72 (very marked symptoms) and assessed 3 clinical signs within each area (head, arms, trunk, and legs): erythema (redness), induration (thickness), and desquamation (scaling).|Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)|Per protocol analysis.||Score on a scale||Standard Deviation|Mean
774556|NCT00749398|Secondary|Percent Body Surface Area (BSA) Involved With Psoriasis||Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5),Week 30 (Visit 6)|Per protocol analysis.||Percent BSA Involved with Psoriasis||Standard Deviation|Mean
774557|NCT00749398|Secondary|Dynamic PGA Score as Assessed by the Investigator|The dynamic PGA was scored twice, at the middle and at the end of the observation period. Clinical improvement from Baseline (Visit 1) was evaluated with a 10 cm-VAS ranging from 0 (no improvement) to 10 (disappearance of lesions) at the Week 14 (Visit 4) and Week 30 (Visit 6) visits.|Week 0 (Visit 1), Week 14 (Visit 4), Week 30 (Visit 6)|Per protocol analysis.||Score on a scale||Standard Deviation|Mean
774558|NCT00749398|Primary|Dynamic Photographic PGA Score as Assessed by Two Dermatologists|The dynamic PGA score resulted from the comparison of two sets of pictures/visits. The dynamic PGA was scored twice, at the middle and at the end of the observation period (comparison between picture sets of Week 0 (Visit 1) and Week 14 (Visit 4) visits and comparison between picture sets of Week 0 (Visit 1) and Week 30 (Visit 6) visits. Dynamic PGA was assessed by two dermatologists and the mean of the two readings was used. Clinical improvement was measured with a 10 centimeter (cm)-visual analogue scale (VAS) ranging from 0 (no improvement) to 10 (disappearance of lesions).|Week 0 (Visit 1), Week 14 (Visit 4), Week 30 (Visit 6)|Per protocol analysis.||Score on a scale||Standard Deviation|Mean
774560|NCT00749398|Primary|Static Photographic Physician Global Assessment (PGA) Score as Assessed by Two Dermatologists|Digital pictures of each participant's whole body were taken at each visit. Static PGA was assessed by two dermatologists on the basis of these pictures at a single point in time. The mean of the two readings from the dermatologists was used. Static PGA score ranged from 0 (no psoriasis) to 5 (extreme psoriasis). The higher the number, the more severe the psoriasis was.|Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)|Per protocol analysis.||Score on a scale||Standard Deviation|Mean
774561|NCT00749463|Secondary|Point Prevalence Smoking Abstinence (PPSA)|Point Prevalence Smoking Abstinence since last visit. Point prevalence abstinence is defined as the percentage of former smokers who are not smoking at a particular point in time, typically at the time of assessment.|24 Weeks|||Participants|||Number
774562|NCT00749463|Primary|Smoking Abstinence|Continuous carbon monoxide (CO)-verified Smoking Abstinence from Quit day|24 Weeks|||Participants|||Number
774563|NCT00749463|Secondary|Smoking Consumption Per Week|Number of cigarettes smoked by subjects reporting smoking since last visit - total during the the week (for non-daily smokers)|24 Weeks from last visit:|||Cigarettes||Standard Deviation|Mean
774564|NCT00749463|Secondary|Smoking Consumption Per Day|Number of cigarettes smoked by subjects reporting smoking since last visit - total during the day (for daily smokers)|24 Weeks from last visit:|||Cigarettes||Standard Deviation|Mean
774565|NCT00749463|Secondary|Carbon Monoxide (CO)-Verified Smoking Reduction|Percentage of participants with carbon monoxide (CO)-verified reduction from baseline in number of cigarettes smoked per day (%)|Baseline to Week 24|||Percentage of Participants||Standard Deviation|Mean
774566|NCT00749463|Primary|Self-Reported Smoking Reduction|Percentage of subjects self-reporting reduction from baseline in number of cigarettes smoked per day|24 Weeks|||Percentage of Participants||Standard Deviation|Mean
774567|NCT00749463|Primary|Treatment-Related Adverse Events|Percentage of subjects with treatment-related adverse events by preferred term, included if the percentage in any single arm was 1% or higher|24 Weeks|Safety Analysis Set (ITT)||Percentage of Participants|||Number
774568|NCT00749476|Primary|Number of Participants Reporting Efficacy|Clinical efficacy was measured by number/location of bleeding episodes, number of injections per bleeding, factor IX consumption, global assessment of efficacy by investigator and patient; biological efficacy (recovery) with BeneFIX was measured just after conversion.|4 months|Intent to Treat (ITT) population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.||Participants|||Number
774569|NCT00749580|Secondary|Virologic Suppression of < 75 Copies/ml at 48 Weeks||at 48 weeks for each patient|||participants|||Number
774570|NCT00749580|Primary|Number of Patients With Suppressed Viral Load(<75 Copies/ml)in Raltegravir 400 mg Bid vs. NRTI Backbone, Each in Combination of Boosted PI Regimen|Number of patients with virologic suppression< 75 copies/ ml at 24 wk,in raltegravir 400 mg bid vs. NRTI backbone, each in combination of boosted PI regimen.|at 24weeks for each patient|||participants|||Number
774571|NCT00749671|Secondary|Patient Recall of Defibrillation Testing|The patient recall of the testing will be assessed at 30 minutes, as answered with a yes/no.|30 minutes|||percentage of patients with DFT recall|||Number
774572|NCT00749671|Primary|Observer's Assessment of Alertness/Sedation (OAAS) Rating Scale at 30 Minutes|"Sedation level was evaluated and graded according to the observer's assessment of alertness/sedation (OAAS) rating scale. This scale has 6 possible measures of consciousness:
OAAS score 5—awake and responds readily to name spoken in normal tone.
OAAS score 4—lethargic responses to name in normal tone.
OAAS score 3—responds only after name is called loudly and/or repeatedly.
OAAS score 2—responds only after name called loudly and mild shaking.
OAAS score 1—does not respond when name is called loudly and mild shaking or prodding.
OAAS score 0—does not respond to noxious stimulation."|30 minutes|||units on a scale||95% Confidence Interval|Mean
774573|NCT00749684|Primary|Relapse Free Survival Time|Median time to recurrence according to Kaplan Maier evaluation|Throughout 12 months of treatment and 24 months of follow-up|||months||Full Range|Median
774574|NCT00749684|Primary|Number of Participants With Disease Recurrence|Number of participants with disease recurrence was being measured.|Throughout 12 months of treatment and 24 months of follow-up|138 participants with malignant melanoma, 88 male participants and 50 female participants were evaluated.||participants|||Number
774575|NCT00749775|Secondary|Number of Participants That Responded to Selara Treatment.|Number of participants among the efficacy analysis population that responded to Selara treatment.|12 weeks|The efficacy analysis population basically consists of the evaluable participants in accordance with the separately prepared analysis plan (participants judged to have been evaluated appropriately).||participants|||Number
774576|NCT00749775|Secondary|Change in Diastolic Blood Pressure Over Time.|The primary analysis item was the mean diastolic blood pressure at 4, 8, and 12 weeks of the observation period or at last evaluation date if Selara was terminated prematurely.|12 weeks|The efficacy analysis population basically consists of the evaluable participants in accordance with the separately prepared analysis plan (participants judged to have been evaluated appropriately).||mmHg||Standard Deviation|Mean
774577|NCT00749775|Secondary|Change in Systolic Blood Pressure Over Time.|The primary analysis item was the mean systolic blood pressure at 4, 8, and 12 weeks of the observation period or at last evaluation date if Selara was terminated prematurely.|12 weeks|The efficacy analysis population basically consists of the evaluable participants in accordance with the separately prepared analysis plan (participants judged to have been evaluated appropriately).||mmHg||Standard Deviation|Mean
774578|NCT00749775|Primary|Number of Participants With Serious Treatment Related Adverse Events.|Serious treatment related adverse events mean those that may lead to death, life-threatening, hospitalization or prolonged hospitalization, a permanent or remarkable disorder/dysfunction, congenital anomaly/congenital deficiency, or other medically significant events or disorder.|12 weeks|No statistical analysis provided for the frequency of serious treatment related adverse events.||participants|||Number
774579|NCT00749775|Primary|Number of Participants With Treatment Related Adverse Events.|Adverse events mean all unfavorable events that occur in participants after administration of Selara, irrespective of causal relationship to Selara (including clinically problematic abnormal changes in laboratory test values). Treatment Related Adverse Events were evaluated in company with the causal relationship to Selara.|12 weeks|No statistical analysis provided for the frequency of Treatment Related adverse events.||participants|||Number
774581|NCT00749931|Primary|The Primary Effectiveness Endpoint is a Measure of Intraoperative Success in Addressing Positive Margins as Detected by Permanent Pathology)by Additional Oriented Tissue Re-excision From the Surgical Cavity.|Tests the efficacy of the device to intra-operatively assess positive margins (superiority) - CSR is 'positive' when all positive margins, as detected by histology, on the main specimen addressed intra-operatively|two weeks after surgery|"The Analysis Set for evaluating intraoperative assessment consisted of patients with at least one histologically positive margin on main lumpectomy specimen (PSS – Positive specimen subjects)"||percentage of participants analyzed|||Number
774582|NCT00749944|Secondary|Change From Baseline in the Number of Cigarettes Smoked Per Day||Baseline (Week 0) to Week 2|FAS; (n)=number of subjects with at least 1 dose of study drug and an observation for a given day.||cigarettes smoked per day||Standard Deviation|Mean
774583|NCT00749944|Secondary|Number of Participants With 7-day Point Prevalence of Abstinence (Smoking Cessation)|Participants who reported no smoking and no use of other nicotine-containing products since the last study visit (during treatment) in the previous 7 days and who did not have carbon monoxide of more than 10 parts per million for that observation (if measured).|Week 5 to Week 13|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.||participants|||Number
774584|NCT00749944|Secondary|Number of Participants With Carbon Monoxide Confirmed Daily Smoking Cessation|Participants who reported no smoking and no use of other nicotine-containing products since the last study visit (on the Nicotine Use Inventory, which was used to collect the information of cigarette or other nicotine use during the study) and who did not have carbon monoxide of more than 10 parts per million at any time from Week 9 to Week 12|Week 9 to Week 12|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.||participants|||Number
774585|NCT00749944|Secondary|Number of Participants Exceeding Thresholds for the Social Dysfunction and Aggression Scale (SDAS): Total Score|SDAS total scores ranged from 0 (not present) to 44 (extremely severe). Participants exceeding the threshold had a SDAS total score of more than 6 out of 44.|Baseline B (Week 2) to Week 4 (Period BC)|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.||participants|||Number
774586|NCT00749944|Secondary|Number of Participants Exceeding Thresholds for the Barratt Impulsiveness Scale – Version 11 (BIS-11): Total Score|The BIS-11 is designed to assess general impulsiveness taking into account the multifactorial nature of the construct. Total score ranged from 30 (less impulsive) to 120 (more impulsive). Participants exceeding the threshold had a BIS-11 total score more than or equal to 70 out of 120. BIS-11 total scores of more than or equal to 70 could reflect clinically important and potentially pathological impulsivity.|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.||participants|||Number
774587|NCT00749944|Secondary|Number of Participants Exceeding Thresholds for the Overt Aggression Scale (Modified) (OAS-m): Suicidality Total Score|The OAS-m contains 3 scales: Aggression, Irritability, and Suicidality. Suicidality total score ranged from 0 (no suicidal tendency) to 16 (extreme/very extreme suicidal tendency). No threshold criterion was determined for OAS-m Suicidality total score.|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|The number of participants above the threshold for the OAS-m Suicidality total score was not analyzed as the majority of observations were recorded as 0.||participants|||Number
774588|NCT00749944|Secondary|Number of Participants Exceeding Thresholds for the Overt Aggression Scale (Modified) (OAS-m): Irritability Total Score|The OAS-m contains 3 scales: Aggression, Irritability, and Suicidality. Irritability total score ranged from 0 (no irritability) to 10 (extreme irritability). Participants exceeding the threshold had an OAS-m Irritability total score of more than or equal to 2 out of 10. OAS-m Irritability total scores of more than or equal to 2 reflect clinically important irritability.|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.||participants|||Number
774589|NCT00749944|Secondary|Number of Participants Exceeding Thresholds for the Overt Aggression Scale (Modified) (OAS-m): Agression Total Score|The OAS-m contains 3 scales: Aggression, Irritability, and Suicidality. Aggression total score ranged from 0 (no aggression) to any number with no upper limit depending on the frequency of agressive behaviour in a week. Participants exceeding the threshold had an OAS-m Aggression total score of more than or equal to 3 out of any number with no upper limit depending on the frequency of agressive behaviour in a week. OAS-m Aggression total scores of more than or equal to 3 reflect clinically important aggression.|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.||participants|||Number
774590|NCT00749944|Secondary|Number of Participants Exceeding Thresholds for the Hamilton Anxiety Scale (HAM-A): Total Score|HAM-A measures treatment-related changes in generalized anxiety symptoms. Total scores ranged from 0 (not affected) to 56 (very severely affected). Participants exceeding the threshold had a HAM-A total score of more than or equal to 14 out of 56. HAM-A total scores of more than or equal to 14 may reflect clinically noteworthy levels of anxiety.|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.||participants|||Number
774600|NCT00749944|Primary|Change From Baseline in the Social Dysfunction and Aggression Scale (SDAS): Total Score|The SDAS contains 11 items with 5 possible responses: 0=not present, 1=doubtful or very mild, 2=mild to moderate, 3=severe, and 4=extremely severe. The SDAS was collected 3 times a day during the inpatient abstinence period (BC). Total scores ranged from 0 (not present) to 44 (extremely severe).|Baseline B (Week 2) to Week 4 (Period BC)|No change from baseline analysis was performed on the SDAS total score as the majority of observations were recorded as 0.||scores on a scale||Standard Error|Least Squares Mean
774591|NCT00749944|Secondary|Number of Participants Exceeding Thresholds for the Montgomery-Asberg Depression Rating Scale (MADRS): Total Score|The MADRS measures the overall severity of depressive symptoms. Total score ranged from 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Participants exceeding the threshold had a MADRS total score of more than 14 out of 60. MADRS total scores exceeding 14 may represent clinically notable effective symptomatology.|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively. Statistical analyses were not performed for Period AB due to the small number of participants exceeding the threshold.||participants|||Number
774592|NCT00749944|Secondary|Number of Participants Exceeding Thresholds for the Profile of Mood States (POMS): Total Score|POMS total mood disturbance (TMD) summary results were presented as transformed T-scores ranging from 30 (less disturbance) to 80 (more disturbance). Participants exceeding the threshold had an increase from baseline of 1 standard deviation of the TMD baseline T-score plus 1 or more.|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.||participants|||Number
774593|NCT00749944|Secondary|Change From Baseline in the Minnesota Nicotine Withdrawal Scale (MNWS): Increased Appetite Subscale|The MNWS increased appetite subscale contains 1 item (increased appetite) rated from 0 to 4 where 0=not at all, 1=slight, 2=moderate, 3=quite a bit, and 4=extreme. Scores ranged from 0 (no increased appetite) to 4 (extreme increased appetite).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.||scores on a scale||Standard Error|Least Squares Mean
774594|NCT00749944|Secondary|Change From Baseline in the Minnesota Nicotine Withdrawal Scale (MNWS): Restlessness Subscale|The MNWS restlessness subscale contains 1 item (restlessness) rated from 0 to 4 where 0=not at all, 1=slight, 2=moderate, 3=quite a bit, and 4=extreme. Scores ranged from 0 (no restlessness) to 4 (extreme restlessness).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.||scores on a scale||Standard Error|Least Squares Mean
774595|NCT00749944|Secondary|Change From Baseline in the Minnesota Nicotine Withdrawal Scale (MNWS): Urge to Smoke Subscale|The MNWS urge to smoke subscale contains 1 item (urge to smoke) rated from 0 to 4 where 0=not at all, 1=slight, 2=moderate, 3=quite a bit, and 4=extreme. Scores ranged from 0 (no urge to smoke) to 4 (extreme urge to smoke).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.||scores on a scale||Standard Error|Least Squares Mean
774596|NCT00749944|Secondary|Change From Baseline in the Minnesota Nicotine Withdrawal Scale (MNWS): Insomnia Domain Subscale|The MNWS insomnia domain subscale contains 2 items (difficulty going to sleep; difficulty staying asleep). Each item was rated from 0 to 4 where 0=not at all, 1=slight, 2=moderate, 3=quite a bit, and 4=extreme. Scores were the average of the 2 items and ranged from 0 (no insomnia) to 4 (extreme insomnia).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.||scores on a scale||Standard Error|Least Squares Mean
774597|NCT00749944|Secondary|Change From Baseline in the Minnesota Nicotine Withdrawal Scale (MNWS): Negative Affect Domain Subscale|The MNWS negative affect domain subscale contains 4 items (depressed mood; irritability, frustration, or anger; anxiety; difficulty concentrating). Each item was rated from 0 to 4 where 0=not at all, 1=slight, 2=moderate, 3=quite a bit, and 4=extreme. Scores were the average from all 4 items and ranged from 0 (no negative affect) to 4 (extreme negative affect).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.||scores on a scale||Standard Error|Least Squares Mean
774598|NCT00749944|Secondary|Change From Baseline in the Minnesota Nicotine Withdrawal Scale (MNWS): Total Score|The MNWS total score contains 9 items (urge to smoke; depressed mood; irritability, frustration, or anger; anxiety; difficulty concentrating; restlessness; increased appetite; difficulty going to sleep; difficulty staying asleep). Each item was rated from 0 to 4 where 0=not at all, 1=slight, 2=moderate, 3=quite a bit, and 4=extreme. Total scores were the average score for all 9 items and ranged from 0 (no withdrawal symptoms) to 4 (extreme withdrawal symptoms).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.||scores on a scale||Standard Error|Least Squares Mean
774599|NCT00749944|Primary|Change From Baseline in the Barratt Impulsiveness Scale – Version 11 (BIS-11): Total Score|The BIS-11 is a 30-item self-report questionnaire designed to assess general impulsiveness taking into account the multifactorial nature of the construct. Possible responses to each item were: 1=rarely/never, 2=occasionally, 3=often, and 4=almost always/always. Scores of Items 1, 7, 8, 9, 10, 12, 13, 15, 20, 29 and 30 were reversed when calculating the total score. Total score ranged from 30 (less impulsive) to 120 (more impulsive).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.||scores on a scale||Standard Error|Least Squares Mean
774675|NCT00744380|Secondary|Duration of Study Drug Administration||Duration of ICU stay, up to 24 weeks|||days||Inter-Quartile Range|Median
774601|NCT00749944|Primary|Change From Baseline in the Overt Aggression Scale (Modified) (OAS-m): Suicidality Total Score|The OAS-m contains 3 scales: Aggression (Questions [Q]1 to 4), Irritability (Q5 to 6), and Suicidality (Q7 to 7b). Suicidality total score was calculated by summing the items Q7 to 7b. Scores for Q7 ranged from 0 (none) to 6 (very extreme) and scores for Q7a to 7b ranged from 0 (none) to 5 (extreme). Total scores ranged from 0 (no suicidal tendency) to 16 (extreme/very extreme suicidal tendency).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|No change from baseline analysis was performed on the OAS-m Suicidality total score as the majority of observations were recorded as 0.||scores on a scale||Standard Error|Least Squares Mean
774602|NCT00749944|Primary|Change From Baseline in the Overt Aggression Scale (Modified) (OAS-m): Irritability Total Score|The OAS-m contains 3 scales: Aggression (Questions [Q]1 to 4), Irritability (Q5 to 6), and Suicidality (Q7 to 7b). Irritability total score was calculated by summing the items in Q5 to 6. Scores for each question ranged from 0 (not at all) to 5 (extreme). Total scores ranged from 0 (no irritability) to 10 (extreme irritability).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.||scores on a scale||Standard Error|Least Squares Mean
774603|NCT00749944|Primary|Change From Baseline in the Overt Aggression Scale (Modified) (OAS-m): Aggression Total Score|The OAS-m contains 3 scales: Aggression (Questions [Q]1 to 4), Irritability (Q5 to 6), and Suicidality (Q7 to 7b). Aggression total score was calculated by summing the weighted scores in Q1 to 4. Scores for each question ranged from 0 (no events) to 5 (very severe events). Total scores ranged from 0 (no aggression) to any number with no upper limit depending on the frequency of agressive behaviour in a week.|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.||scores on a scale||Standard Error|Least Squares Mean
774604|NCT00749944|Primary|Change From Baseline in the Hamilton Anxiety Scale (HAM-A): Total Score|HAM-A measures treatment-related changes in generalized anxiety symptoms and is a 14-item questionnaire. Each item was scored from 0 (not present) to 4 (very severe) and a lower score indicated less affected. Total scores ranged from 0 (not affected) to 56 (very severely affected).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.||scores on a scale||Standard Error|Least Squares Mean
774605|NCT00749944|Primary|Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS): Total Score|The MADRS measures the overall severity of depressive symptoms and is a 10-item checklist. Each item was rated on a scale of 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.||scores on a scale||Standard Error|Least Squares Mean
774606|NCT00749944|Primary|Change From Baseline in the Profile of Mood States (POMS): Confusion Subscale|POMS Confusion subscale data were responses to 7 items regarding ‘How you feel right now?’ on a scale of 0=not at all, 1=a little, 2=moderately, 3=quite a bit, and 4=extremely. All items were rated in the same direction except for Efficient. Summary results (subscale scores) were presented as transformed T-scores ranging from 30 (less disturbance) to 80 (more disturbance).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.||scores on a scale||Standard Error|Least Squares Mean
774607|NCT00749944|Primary|Change From Baseline in the Profile of Mood States (POMS): Fatigue Subscale|POMS Fatigue subscale data were responses to 7 items regarding ‘How you feel right now?’ on a scale of 0=not at all, 1=a little, 2=moderately, 3=quite a bit, and 4=extremely. All items were rated in the same direction. Summary results (subscale scores) were presented as transformed T-scores ranging from 30 (less disturbance) to 80 (more disturbance).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.||scores on a scale||Standard Error|Least Squares Mean
774608|NCT00749944|Primary|Change From Baseline in the Profile of Mood States (POMS): Vigor Subscale|POMS Vigor subscale data were responses to 8 items regarding ‘How you feel right now?’ on a scale of 0=not at all, 1=a little, 2=moderately, 3=quite a bit, and 4=extremely. Summary results (subscale scores) were presented as transformed T-scores ranging from 30 (less disturbance) to 80 (more disturbance).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.||scores on a scale||Standard Error|Least Squares Mean
774609|NCT00749944|Primary|Change From Baseline in the Profile of Mood States (POMS): Anger-Hostility Subscale|POMS Anger-Hostility subscale data were responses to 12 items regarding ‘How you feel right now?’ on a scale of 0=not at all, 1=a little, 2=moderately, 3=quite a bit, and 4=extremely. Summary results (subscale scores) were presented as transformed T-scores ranging from 30 (less disturbance) to 80 (more disturbance).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.||scores on a scale||Standard Error|Least Squares Mean
774697|NCT00744523|Secondary|Target Lesion Revascularization at 30 Days|Number of subjects with any repeat invasive procedure, including angioplasty, stenting, endarterectomy, or thrombolysis, performed to open or increase lumen diameter inside or within 10 mm of the previously treated lesion.|Up to 30 days after the procedure was performed|||participants|||Number
774610|NCT00749944|Primary|Change From Baseline in the Profile of Mood States (POMS): Depression-Dejection Subscale|POMS Depression-Dejection subscale data responses to 15 items regarding ‘How you feel right now?’ on a scale of 0=not at all, 1=a little, 2=moderately, 3=quite a bit, and 4=extremely. Summary results (subscale scores) were presented as transformed T-scores ranging from 30 (less disturbance) to 80 (more disturbance).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.||scores on a scale||Standard Error|Least Squares Mean
774611|NCT00749944|Primary|Change From Baseline in the Profile of Mood States (POMS): Tension-Anxiety Subscale|POMS Tension-Anxiety subscale data were responses to 9 items regarding ‘How you feel right now?’ on a scale of 0=not at all, 1=a little, 2=moderately, 3=quite a bit, and 4=extremely. All items were rated in the same direction except for Relaxed. Summary results (subscale scores) were presented as transformed T-scores ranging from 30 (less disturbance) to 80 (more disturbance).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.||scores on a scale||Standard Error|Least Squares Mean
774612|NCT00749944|Primary|Change From Baseline in the Profile of Mood States (POMS): Total Mood Disturbance (TMD)|POMS TMD were responses to 65 items in 6 subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor, Fatigue, and Confusion), on ‘How you feel right now?’ (scale:0=not at all, 1=a little, 2=moderately, 3=quite a bit, 4=extremely). All items were rated in the same direction except for Relaxed and Efficient in the Tension-Anxiety and Confusion subscales. TMD was the sum of the scores of all 6 subscales but weighting Vigor negatively. Summary results (TMD scores) were presented as transformed T-scores ranging from 30 (less disturbance) to 80 (more disturbance).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|Full analysis set (FAS): All randomized subjects with at least 1 dose of study drug and at least 1 post-baseline neuropsychiatric evaluation or Minnesota Nicotine Withdrawal Scale (MNWS) obtained; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.||scores on a scale||Standard Error|Least Squares Mean
774613|NCT00749957|Secondary|Participants With Changes in Best Corrected Visual Acuity|Increase in BCVA of 7 or more letters at Year 2 visit compared to average baseline value|2 years|||participants|||Number
774614|NCT00749957|Secondary|Participants With Changes in Visual Fields|Improvement in the central 30 degree visual field, measured by static perimetry, at one or more time points after treatment, that was greater than the limit of agreement for baseline values .|2 years|||participants|||Number
774615|NCT00749957|Primary|Number of Participants Experiencing Ocular or Non-ocular Adverse Events||2 years|||participants|||Number
774616|NCT00743574|Primary|AUC (Area Under the Curve at 0, 0.5, 1, 1.5 and 2 Hours) During Oral GTT at Completion, at 3 Months|AUC (Area under the curve at 0, 0.5, 1, 1.5 and 2 hours)for glucose was determined at completion of 3 months intervention for 2 hour oral GTT|3 months|Number determined by all participants who completed all interventions and procedures||mg/min/120min||Standard Deviation|Mean
774617|NCT00743574|Primary|AUC (Area Under a Curve at 0, 0.5, 1, 1.5 and 2 Hours) Insulin During 2 Hour GTT at Completion, at 3 Months|Following 3 months intervention, AUC insulin was determined during 2 hour oral GTT|3 months|Number determined by completion of all study interventions and procedures||µIU/ml/120min||Standard Deviation|Mean
774618|NCT00743574|Primary|Fasting Glucose Levels at Completion of Treatment, at 3 Months|Fasting glucose levels drawn after 3 months completion during oral GTT|3 months|Number determined based on all interventions and procedures completed.||mg/dl||Standard Deviation|Mean
774619|NCT00743574|Primary|Fasting Insulin Levels at Study Completion After 3 Month Treatment|Fasting insulin levels at study completion after 3 month treatment|3 months intervention|Number determined by all those who completed all interventions and procedures.||µIU/ml||Standard Deviation|Mean
774620|NCT00743574|Primary|Participants Were Assessed at Study Completion After 3 Month Treatment|Fasting HbA1C levels at study completion after 3 month treatment|Completion|Number determined by those who completed all interventions and procedures.||percentage||Standard Deviation|Mean
774621|NCT00743574|Secondary|Serum Levels of C-reactive Protein at Completion of 3 Months Treatment Compared to Baseline.|Serum levels of C-reactive protein upon completion, at 3 months|3 months|All subjects who completed treatment for 3 months||mg/L||Inter-Quartile Range|Median
774622|NCT00743652|Other Pre-specified|Correlation of OPA and IgG Values for Each 13vPnC Serotype 1 Month After the Relevant Catch-up Dose||28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.|Correlative analysis output data are only available as figures and were not analyzed or presented statistically.||Participants|||Number
774623|NCT00743652|Other Pre-specified|Correlation of OPA and IgG Values for Each 13vPnC Serotype 1 Month After the Toddler Dose||28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3.|Correlative analysis output data are only available as figures and were not analyzed or presented statistically.||Participants|||Number
774624|NCT00743652|Other Pre-specified|Correlation of OPA and IgG Values for Each 13vPnC Serotype 1 Month After the Infant Series||28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.|Correlative analysis output data are only available as figures and were not analyzed or presented statistically.||Participants|||Number
774625|NCT00743652|Other Pre-specified|Pneumococcal OPA GMTs 1 Month After the Relevant Catch-up Dose|Antibody geometric mean titers as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). GMTs were calculated using all participants with available data for the specified blood draw. CIs for the GMTs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the titers.|28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.|Evaluable immunogenicity population. N=number of participants with a determinate OPA antibody titer to the given serotype.||Titers||95% Confidence Interval|Geometric Mean
774698|NCT00744523|Secondary|Restenosis at 30 Days|Number of subjects with re-narrowing of the lesion at 30 days as defined as a >= 50% stenosis measured by duplex ultrasound scan.|Up to 30 days after the procedure was performed|||participants|||Number
774626|NCT00743652|Other Pre-specified|Pneumococcal OPA GMTs 1 Month After the Toddler Dose|Antibody geometric mean titers as measured by OPA assay for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A). GMTs were calculated using all subjects with available data for the specified blood draw. CIs for the GMTs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the titers.|28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, after vaccination 2 for Group 3.|Evaluable immunogenicity population. N=number of participants with a determinate OPA antibody titer to the given serotype.||Titers||95% Confidence Interval|Geometric Mean
774627|NCT00743652|Other Pre-specified|Pneumococcal OPA Geometric Mean Titers (GMTs) 1 Month After the Infant Series|Antibody geometric mean titers as measured by OPA assay for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A). GMTs were calculated using all participants with available data for the specified blood draw. CIs for the GMTs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the titers.|28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.|Evaluable immunogenicity population. N=number of participants with a determinate OPA antibody titer to the given serotype.||Titers||95% Confidence Interval|Geometric Mean
774628|NCT00743652|Other Pre-specified|Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Relevant Catch-up Dose|Percentage of participants in 13vPnC Groups 4 and 5 achieving OPA with 95% CI for serotypes 4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F, and 19A. Exact 2-sided CI based upon the observed proportion of participants. The LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43, Pn7F, 210; Pn09V, 345; Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; and Pn23F, 13. Limit of detection (LOD) established as lowest titer possible in assay, which was 8. OPA titers below LLOQ set to 0.5*LOD for analysis.|28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.|Evaluable immunogenicity population. N=number of participants with a determinate OPA antibody titer to the given serotype.||Percentage of Participants||95% Confidence Interval|Number
774629|NCT00743652|Other Pre-specified|Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Toddler Dose|Percentage of participants in 13vPnC Groups 1, 2 and 3 achieving OPA with 95% CI for serotypes 4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F, and 19A. Exact 2-sided CI based upon the observed proportion of participants. The LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43, Pn7F, 210; Pn09V, 345; Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; and Pn23F, 13. Limit of detection (LOD) established as lowest titer possible in assay, which was 8. OPA titers below LLOQ set to 0.5*LOD for analysis.|28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3.|Evaluable immunogenicity population. N=number of participants with a determinate OPA antibody titer to the given serotype.||Percentage of Participants||95% Confidence Interval|Number
774630|NCT00743652|Other Pre-specified|Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥Lower Limit of Quantitation (LLOQ) Measured 1 Month After the Infant Series|Percentage of participants in 13vPnC Groups 1, 2, and 3 achieving OPA with 95% CI for serotypes 4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F, and 19A. Exact 2-sided CI based upon the observed proportion of participants. The LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43, Pn7F, 210; Pn09V, 345; Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; and Pn23F, 13. Limit of detection (LOD) established as lowest titer possible in assay, which was 8. OPA titers below LLOQ set to 0.5*LOD for analysis.|28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.|Evaluable immunogenicity population. N=number of participants with a determinate OPA antibody titer to the given serotype.||Percentage of Participants||95% Confidence Interval|Number
774631|NCT00743652|Other Pre-specified|GMC for Serotype-specific Pneumococcal IgG Antibodies 1 Month After the Relevant Catch-up Dose|Antibody GMCs (mcg/mL) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) with 2-sided 95% CIs were evaluated. CIs are back transformations of confidence levels based on Student t distribution for mean logarithm of concentrations. GMCs were calculated using all participants with available data for specified blood draw.|28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.|Evaluable immunogenicity population. N=number of participants with a determinate antibody concentration to the specified serotype.||mcg/mL||95% Confidence Interval|Geometric Mean
774632|NCT00743652|Other Pre-specified|GMC for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Toddler Dose|Antibody GMCs (mcg/mL) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A). GMC (13vPnC) with 2-sided 95% CIs were evaluated. CIs are back transformations of confidence levels based on Student t distribution for mean logarithm of concentrations. GMCs were calculated using all participants with available data for specified blood draw.|28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, after vaccination 2 for Group 3.|Evaluable immunogenicity population. N=number of participants with a determinate antibody concentration to the specified serotype.||mcg/mL||95% Confidence Interval|Geometric Mean
774633|NCT00743652|Other Pre-specified|Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Infant Series|Antibody GMCs (mcg/mL) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) with 2-sided 95% CIs were evaluated. CIs are back transformations of confidence levels based on Student t distribution for mean logarithm of concentrations. GMCs were calculated using all participants with available data for specified blood draw.|28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.|Evaluable immunogenicity population. N=number of participants with a determinate antibody concentration to the specified serotype.||mcg/mL||95% Confidence Interval|Geometric Mean
774973|NCT00753363|Primary|Insulin Sensitivity|Insulin resistance is defined as a reduction in glucose utilization rate elicited by a given insulin concentration. Glucose utilization is measured during a three hour hyperinsulinemic-euglycemic clamp and is presented as a measure of insulin sensitivity. This is one of the most sophisticated methods to measure insulin sensitivity.|Baseline and 6 month|||μmol/kgFFM/min||Standard Error|Mean
774634|NCT00743652|Other Pre-specified|Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Relevant Catch-up Dose|Percentage of participants in 13vPnC Groups 4 and 5 achieving predefined antibody threshold ≥0.15 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants.|28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.|Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype.||Percentage of Participants||95% Confidence Interval|Number
774635|NCT00743652|Other Pre-specified|Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Toddler Dose|Percentage of participants in 13vPnC Groups 1, 2, and 3 achieving predefined antibody threshold ≥0.15 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants.|28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3.|Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype.||Percentage of Participants||95% Confidence Interval|Number
774636|NCT00743652|Other Pre-specified|Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Infant Series|Percentage of participants in 13vPnC Groups 1, 2, and 3 achieving predefined antibody threshold ≥0.15 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants.|28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.|Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype.||Percentage of Participants||95% Confidence Interval|Number
774637|NCT00743652|Other Pre-specified|Number of Cases of Invasive Pneumococcal Disease (IPD) in Participants Less Than 5 Years of Age Due to Any Serotype Contained in 13vPnC|In order to assess the impact of 13vPnC on the incidence of IPD in the Yukon Kuskokwim (YK) Delta region, the Centers for Disease Control and Prevention (CDC) Arctic Investigation Program (AIP) accessed IPD data through evaluation of ongoing statewide IPD surveillance in Alaska. The CDC’s AIP followed IPD (including serotype and vaccination history) to show whether identified cases of IPD received Prevnar, 13vPnC, or both. These data were combined with statewide data and used to identify the overall trend in IPD in the YK Delta region after introduction of 13vPnC.|Baseline to 6 months after last vaccination|Safety Population||Participants|||Number
774638|NCT00743652|Secondary|Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 2|Systemic events (any fever 38 degrees C or higher, decreased appetite, irritability, increased sleep, decreased sleep, hives [urticaria], and use of antipyretic medication) were reported using a diary card. Participants may have been represented in more than 1 category.|Day 1 through Day 7 after vaccination 2 for Group 4|Safety Population; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants with specific characteristic||Percentage of Participants|||Number
774639|NCT00743652|Secondary|Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 1|Systemic events (any fever 38 degrees Celsius [C] or higher, decreased appetite, irritability, increased sleep, decreased sleep, hives [urticaria], and use of antipyretic medication) were reported using a diary card. Participants may have been represented in more than 1 category.|Day 1 through Day 7 after vaccination 1 for Group 4 and after the single vaccination in Group 5.|Safety Population; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants with specific characteristic||Percentage of Participants|||Number
774640|NCT00743652|Secondary|Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 2|Local reactions were reported by the parent/legal guardian using a diary card. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may have been represented in more than 1 category.|Day 1 through Day 7 after vaccination 2 for Group 4|Safety Population; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants with specific characteristic||Percentage of Participants|||Number
774641|NCT00743652|Secondary|Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 1|Local reactions were reported by the parent/legal guardian using a diary card. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may have been represented in more than 1 category.|Day 1 through Day 7 after vaccination 1 for Group 4 and after the single vaccination in Group 5.|Safety Population: all participants who received at least 1 dose of 13vPnC; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants with specific characteristic||Percentage of Participants|||Number
774642|NCT00743652|Secondary|Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Relevant Catch-up Dose|Percentage of participants in 13vPnC Groups 4 and 5 achieving predefined antibody threshold ≥1.0 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants.|28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.|Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype.||Percentage of Participants||95% Confidence Interval|Number
775211|NCT00755222|Primary|Change From Baseline in PDQ Intercourse Discomfort|"Peyronie's disease intercourse discomfort Scale: 0-15 lower numbers reflect 'less intercourse discomfort'; higher numbers reflect 'more intercourse discomfort'
Change from baseline equals Week 36 minus baseline. Negative change reflects improvement in the intercourse discomfort scale."|Baseline to Week 36 or LOCF|||scores on a scale||Standard Deviation|Mean
774643|NCT00743652|Secondary|Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Toddler Dose|Percentage of participants in 13vPnC Groups 1, 2, and 3 achieving predefined antibody threshold ≥1.0 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants.|28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3.|Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype.||Percentage of Participants||95% Confidence Interval|Number
774644|NCT00743652|Secondary|Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Infant Series|Percentage of participants in 13vPnC Groups 1, 2, and 3 achieving predefined antibody threshold ≥1.0 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants.|28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.|Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype.||Percentage of Participants||95% Confidence Interval|Number
774645|NCT00743652|Secondary|Percentage of Participants Achieving Serum IgG Antibody Level ≥0.35 Mcg/mL Prior to Vaccination With 13vPnC (Groups 4 and 5 Only)|Percentage of participants in 13vPnC Groups 4 and 5 achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants.|28 to 56 days before vaccination 2 for Group 4, and before the single vaccination in Group 5.|Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype.||Percentage of Participants||95% Confidence Interval|Number
774646|NCT00743652|Primary|Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Relevant Catch-Up Dose|Percentage of participants in 13vPnC Groups 4 and 5 achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants.|28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.|Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype.||Percentage of Participants||95% Confidence Interval|Number
774647|NCT00743652|Primary|Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Toddler Dose|Percentage of participants in 13vPnC Groups 1, 2, and 3 achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants.|28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3.|Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype.||Percentage of Participants||95% Confidence Interval|Number
774648|NCT00743652|Primary|Percentage of Participants Achieving Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Level ≥0.35 Micrograms Per Milliliter (Mcg/mL) 1 Month After the Infant Series|Percentage of participants in 13vPnC Groups 1, 2 and 3 achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants.|28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.|Evaluable immunogenicity population: received treatments as randomized at all expected doses, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations. N=number of participants with a determinate IgG antibody concentration to the given serotype.||Percentage of Participants||95% Confidence Interval|Number
774649|NCT00743717|Primary|Knee Score at 2 Years Post Operation|"The criterion used to assess the outcome is a Knee Score (as defined by Knee Society Clinical Rating System) > 80 points at two-years follow-up. This scoring system is defined in the following paper: Insall JN, Dorr LD, Scott RD, and Scott WN (1989). Rationale of the Knee Society clinical rating system. Clin Orthop(248): 13-4. The scale ranges from minimum of 0 (worst) to maximum of 100 (best). Knee Score > 80 was used as a criterion to assess success."|within 2 years|||units on a scale||Full Range|Mean
774650|NCT00743730|Secondary|Parent Satisfaction With the Administration Technique|Parents were asked “Overall, how satisfied were you with the pain relief your child received after surgery?” Response options were: 1. Very Dissatisfied, 2. Dissatisfied, 3. Satisfied, 4. Very Satisfied. Responses were scored on a 1-4 scale, with Very Dissatisfied = 1; Dissatisfied = 2; Satisfied = 3; Very Satisfied = 4.|parents, once at the end of study|Data was obtained from parents who completed the satisfaction survey||units on a scale||Standard Deviation|Mean
774651|NCT00743730|Secondary|Side Effect Profile (Administration of Medications to Treat Side Effects)||Daily, for up to 3 months||06/2017||||
774652|NCT00743730|Primary|Median Pain Score During Shift 1, as Measured With the Face, Legs, Activity, Cry, Consolability Scale|Pain is measured with the Face, Legs, Activity, Cry, Consolability scale (FLACC) is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0–10 with 0 representing no pain. The median pain score over the first shift (24 hours) is reported.|First 24 hours on study|||units on a scale||Inter-Quartile Range|Median
775642|NCT00758602|Secondary|Serum Creatinine (Micromoles Per Liter [µmol/L])|The mean serum creatinine values in µmol/L at Baseline (BL), Weeks 2, 4, 13, 26, 39, and 52.|BL, Weeks 2, 4, 13, 26, 39, and 52|ITT population; n (number) = number of participants assessed for the specified parameter at a given visit.||µmol/L||Standard Deviation|Mean
774653|NCT00744042|Secondary|Area Under Serum Concentration-time Curve to Last Measurable Concentration of Asfotase Alfa (AUCt)|Area under serum concentration-time curve to last measurable concentration during intensive PK sampling interval.|Study Week 1 (0 to 168 hours post-dose). Study Week 2 and Study Week 3 (0 to 48 hours post-dose).|ITT population. N=number of patients who received a full dose of asfotase alfa and had sufficient data for non-compartmental analysis.||h*U/L||Standard Deviation|Mean
774654|NCT00744042|Secondary|Time at Maximum Serum Concentration of Asfotase Alfa (Tmax)|Time at maximum serum concentration observed during intensive PK sampling interval.|Study Week 1 (0 to 168 hours post-dose). Study Week 2 and Study Week 3 (0 to 48 hours post-dose).|ITT population. N=number of patients who received a full dose of asfotase alfa and had sufficient data for non-compartmental analysis.||hour||Standard Deviation|Mean
774655|NCT00744042|Secondary|Maximum Serum Concentration of Asfotase Alfa (Cmax)|Maximum serum concentration observed during intensive PK sampling interval.|Study Week 1 (0 to 168 hours post-dose). Study Week 2 and Study Week 3 (0 to 48 hours post-dose)|ITT population. N=number of patients who received a full dose of asfotase alfa and had sufficient data for non-compartmental analysis.||U/L||Standard Deviation|Mean
774656|NCT00744042|Primary|Change in Rickets Severity From Baseline to Week 24, Based on Assessment of Skeletal Radiographs Using Radiologic Global Impression of Change (RGI-C)|"A 7-point RGI-C (Radiographic Global Impression of Change) score was used to rate change in rickets severity. Scores ranged from -3 (severe worsening of rickets) to +3 (complete healing of rickets). Only those patients with a minimum score of +2 indicating substantial healing of rickets) were considered responders. Three pediatric radiologists not affiliated with the conduct of the study performed the ratings. Average scores were derived for each patient at each assessment."|24 weeks|ITT (intention to treat)||Units on a scale||Full Range|Median
774657|NCT00744055|Primary|Clinician-Administered PTSD Scale|Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). A higher score is associated with higher severity of PTSD. The score is interpreted as follows: 0-19=Asymptomatic/few symptoms 20-39=Sub-threshold/mild PTSD 40-59=Threshold PTSD/moderate 60-79=Severe PTSD >80=Extreme PTSD|12 weeks|||units on a scale||Standard Deviation|Mean
774658|NCT00744055|Primary|Number of Drinking Days|Using the Timeline Follow Back method, a calendar method for assessing drug and alcohol use|12 weeks|||days||Standard Deviation|Mean
774659|NCT00744237|Secondary|Change From Baseline in Insulin Resistance Based on Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)|Change from Baseline in Insulin Resistance based on homeostasis model assessment of insulin resistance (HOMA-IR) at week 26, Last Observation Carried Forward (LOCF). The HOMA-IR is the the product of the blood Glucose and Insulin levels, divided by a constant. HOMA-IR is expressed as the following: HOMA-IR = fasting serum insulin (μU/ml) × fasting plasma glucose (mmol/l) / 22.5|[visit 5(week 0) and visit 14(week 26)]|||Unit on a scale||Standard Deviation|Mean
774660|NCT00744237|Primary|Change From Baseline in Mean Glycosylated Hemoglobin (HbA1c) at Week 26|Change from baseline in glycosylated hemoglobin (HbA1c) over 26 weeks, Last Observation Carried Forward.|visit 5(week 0) and visit 14(week 26)|||Percentage||Standard Deviation|Mean
774661|NCT00744263|Other Pre-specified|Percentage of Participants With Newly Diagnosed Chronic Medical Condition|Percentage of participants with newly diagnosed chronic medical conditions (including autoimmune or neuroinflammatory disease) in the immunogenicity subset were reported as per planned analysis.|From 1 month after vaccination up to 6 months after vaccination|Immunogenicity subset included participants enrolled in the subset who received study vaccine, were able to complete e-diary and fulfilled other study procedures.||percentage of participants|||Number
774662|NCT00744263|Other Pre-specified|Percentage of Participants Who Died|Deaths collected throughout the case acquisition period were presented.|From signing of informed consent form up to case acquisition period defined as accumulation of 130 VT cases (mean follow-up was 3.97 years)|Safety population included all participants who received study vaccine and who had any safety data.||percentage of participants|||Number
774663|NCT00744263|Other Pre-specified|Percentage of Participants With Pre-specified Systemic Events Within 7 Days After Vaccination|Systemic events (fever, fatigue, headache, chills, rash, vomiting, decreased appetite, diarrhea, new generalized muscle/joint pain [new muscle/joint pain], aggravated generalized muscle/joint pain [aggravated muscle/joint pain], use of medication to treat pain/fever) reported using an e-diary. Fever scaled as Absent(<38 degrees C); Mild(greater than or equal to [>=]38 to <38.5 degrees C); Moderate(>=38.5 to <39 degrees C); Severe(>=39 to less than or equal to [<=]40 degrees C); Potentially life threatening (>40 degrees C). Fatigue, headache, new/aggravated muscle/joint pain scaled as Mild(no interference); Moderate(some interference); Severe(prevented routine activity). Vomiting scaled as Mild(1-2 times in 24 hours [hrs]); Moderate(>2 times in 24 hrs); Severe(required intravenous hydration). Diarrhea scaled as Mild(2-3 loose stools in 24 hrs); Moderate(4-5 loose stools in 24 hrs); Severe(>=6 loose stools in 24 hrs). Percentage of participants with systemic events were reported.|Within 7 days after vaccination|Immunogenicity subset. Participants may be represented in more than 1 category. Here 'N' (number of participants analyzed) signifies participants with known values for any systemic event and 'n' signifies participants with known values for specified systemic event.||percentage of participants||95% Confidence Interval|Number
774664|NCT00744263|Other Pre-specified|Percentage of Participants With Pre-specified Local Reactions Within 7 Days After Vaccination|Local reactions were reported using electronic diary (e-diary). Redness and swelling scaled as Any (redness or swelling present); Absent (no or minimal); Mild (2.5 centimeter [cm] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (>10.0 cm). Pain scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity). Limitation of arm movement scaled as Any (limitation present); Absent (no limitation of arm movement); Mild (some limitation of arm movement); Moderate (unable to move arm above head, but able to move arm above shoulder); Severe (unable to move arm above shoulder). Percentage of participants with local reactions were reported. Participants may be represented in more than 1 category.|Within 7 days after vaccination|Immunogenicity subset included participants enrolled in the subset who received study vaccine, were able to complete e-diary and fulfilled other study procedures. Here 'N' (number of participants analyzed) signifies participants with known values for any local reaction and 'n' signifies participants with known values for specified local reaction.||percentage of participants||95% Confidence Interval|Number
775643|NCT00758602|Secondary|Participant and Graft Survival|The percentage of participants surviving with grafts intact at 6 and 12 months after renal transplant.|Months 6 and 12|ITT population||percentage of participants|||Number
774665|NCT00744263|Secondary|Number of Participants With First Episodes of Vaccine-type Invasive Pneumococcal Disease (VT-IPD) Cases|VT-IPD was defined as the presence of Streptococcus pneumoniae in a sterile site (blood, cerebrospinal fluid, pleural fluid, peritoneal fluid, pericardial fluid, surgical aspirate, bone, or joint fluid).|Baseline up to occurrence of first episode of VT-IPD, death, withdrawal of consent, loss to follow-up, participant request or end of case acquisition defined as accumulation of 130 VT cases (mean follow-up was 3.97 years)|PP population: eligible participants who received study vaccine, 65 years or older, identified with CAP (pre-defined criteria) or had IPD; symptom onset at least 14 days after vaccination; immunocompetent at time of episode; no major protocol violations as determined by clinical scientist/medical monitor.||participants|||Number
774666|NCT00744263|Secondary|Number of Participants With First Episode of Nonbacteremic/Noninvasive (NB/NI) Vaccine-type Community-acquired Pneumonia (VT-CAP)|CAP was defined based on clinical and radiological criteria. Microbiological criteria differentiate different categories of CAP. Clinical criteria: presence of 2 or more criteria from following: cough, production of purulent sputum/change in sputum character, temperature >38.0 degrees C or <36.1 degrees C, auscultatory findings consistent with pneumonia including rales and/or evidence of pulmonary consolidation, leukocytosis (>10*10^9 white blood cells/liter or >15% bands), C-reactive protein level >3 times upper limit of normal, hypoxemia with partial oxygen pressure <60 mmHg. Radiological criteria: pneumonia confirmation by adjudication committee via lateral, posterior-anterior chest x-ray or anterior-posterior chest x-ray. Microbiological criteria: Confirmed VT pneumococcal CAP (by SSUAD) where a blood culture result was available and was negative and for which any other sterile culture results were negative for Streptococcus pneumoniae.|Baseline up to occurrence of first episode of NB/NI VT-CAP, death, withdrawal of consent, loss to follow-up, participant request or end of case acquisition defined as accumulation of 130 VT cases (mean follow-up was 3.97 years)|PP population: eligible participants who received study vaccine, 65 years or older, identified with CAP (pre-defined criteria) or had IPD; symptom onset at least 14 days after vaccination; immunocompetent at time of episode; no major protocol violations as determined by clinical scientist/medical monitor.||participants|||Number
774667|NCT00744263|Primary|Number of Participants With First Episode of Confirmed Vaccine-type Community-acquired Pneumonia (VT-CAP)|CAP was defined based on clinical and radiological criteria. Microbiological criteria differentiate different categories of CAP. Clinical criteria: presence of 2 or more criteria from following: cough, production of purulent sputum/change in sputum character, temperature greater than (>) 38.0 degrees Celsius (C) or less than (<) 36.1 degrees C, auscultatory findings consistent with pneumonia including rales and/or evidence of pulmonary consolidation, leukocytosis (>10*10^9 white blood cells/liter or >15 percent (%) bands), C-reactive protein level >3 times upper limit of normal, hypoxemia with partial oxygen pressure <60 millimeter of mercury (mmHg). Radiological criteria: pneumonia confirmation by adjudication committee via lateral, posterior-anterior chest x-ray or anterior-posterior chest x-ray. Microbiological criteria: VT Streptococcus pneumonia culture from blood, pleural fluid or other sterile site and/or positive VT serotype-specific urinary antigen detection (SSUAD).|Baseline up to occurrence of first episode of VT-CAP, death, withdrawal of consent, loss to follow-up, participant request or end of case acquisition defined as accumulation of 130 VT cases (mean follow-up was 3.97 years)|Per-protocol(PP) population: eligible participants who received study vaccine, 65 years or older, identified with CAP(pre-defined criteria) or had invasive pneumococcal disease(IPD); symptom onset at least 14 days after vaccination; immunocompetent at time of episode; no major protocol violations as determined by clinical scientist/medical monitor.||participants|||Number
774668|NCT00744328|Secondary|To Explore the Relationship of Remission and Response to the Subjects’ Serum Levels of Estradiol.||Monthly||||||
774669|NCT00744328|Secondary|To Evaluate the Durability of Maternal Response to Estradiol, Sertraline, and Placebo in a Continuation Phase Through the Time the Infant is Assessed at 6.5 Months of Age.||yearly||||||
774670|NCT00744328|Secondary|Infant Serum Concentrations of Estradiol in 3 Treatment Arms||monthly||||||
774671|NCT00744328|Secondary|Infant Development Among 6.5 Month Old Children of Mothers With PPMD, as Assessed by Bayley Scales of Infant Development||yearly||||||
774672|NCT00744328|Primary|To Test the Efficacy of Estradiol for the Treatment of Postpartum Depression - Percent Change in SIGH-ADS29|Depression was assessed with the Structured Interview Guide for the Hamilton Depression Rating Scale - Atypical Depression Symptoms Version (SIGH-ADS29). The scale incorporates the 17 and 21-item Hamilton Rating Scales for Depression (HRSD) as well as 8 atypical symptoms of depression. Scores range from 0 to 90, where a higher score corresponds to a higher level of depressive symptomatology.|Week 8|Analyses presented are Last Observation Carried Forward. For women who completed the 8 week trial the percent change was measured from baseline to week 8. For non-completers, the percent change was measured from baseline to last observation.||percentage change in SIGH-ADS29 Score||Standard Deviation|Mean
774673|NCT00744380|Secondary|Hospital Anxiety and Depression Scale (HADS) Score|The HADS consists of 14 questions, seven for anxiety and seven for depression. Each item is scored from 0 to 3, with a cut-off cumulative score of 11 for both subscales indicative of anxiety or depression. This scoring tool has been used for 30 years, possesses excellent reliability and validity, and avoids reliance conditions that are also common somatic symptoms of illness such fatigue, insomnia, and hypersomnia. The maximum score for each subscale is 21 with a maximum possible cumulative score of 42. The minimum score for each subscale is 0. The minimum cumulative score is 0|Duration of hospital stay, up to 24 weeks|Only subjects capable of performing the HADS were provided the assessment. Seven subjects were excluded.||units on a scale||Standard Deviation|Mean
774674|NCT00744380|Secondary|Manifestations of Acute Stress Disorder by Impact of Event Scale - Revised (IES-R)|The IES-R evaluates subjective distress caused by traumatic events and assesses manifestations of post-traumatic stress disorder (PTSD) or acute stress disorder. It is not diagnostic but possesses excellent reliability and validity for manifestations of PTSD. The IES-R has three subscales (eight items on intrusion, eight items on avoidance, and six items on hyperarousal). Each item is scored on a four point scale: 0 = “not at all,” 1 = “a little bit,” 2 = “moderately often,” 3 = “quite a bit,” and 4 = “extremely often.” The total score of each subscale may be averaged and a cumulative score of 30 is indicative of the presence of PTSD. The maximum score for each subscale is 32 for intrusion, 32 for avoidance, and 24 for hyperarousal. The minimum cumulative score is 0 and the maximum cumulative score possible is 88.|Duration of hospital stay, up to 24 weeks|Only subjects capable of performing the IES-R were provided the assessment. Seven subjects were excluded.||units on a scale||Standard Deviation|Mean
774676|NCT00744380|Secondary|ICU Experiences by Administering ICU Stressful Experiences Questionnaire (ICU-SEQ)|The ICU-SEQ assesses patient recall of their ICU experience. The ICU-SEQ assesses both psychological (e.g. fearfulness, anxiety) and physical (e.g. pain, difficulty breathing) perceptions of ICU patients who have received mechanical ventilation. It consists of 29 potentially stressful experiences with seven items specifically addressing the endotracheal tube. The extent that patients are bothered by each item is scored on a five point scale: 0 = “not at all,” 1 = “a little bit,” 2 = “moderately,” 3 = “quite a bit,” and 4 = “extremely.” The cumulative score is an integer interpreted as interval data with higher scores indicating greater stressful experiences associated with the ICU. The minimum score is 0 and the maximum score possible is 116.|Duration of hospital stay, up to 24 weeks|Only subjects capable of performing the ICU-SEQ were provided the assessment. Seven subjects were excluded.||units on a scale||Full Range|Median
774677|NCT00744380|Secondary|Sedation-related Adverse Effects||Duration of ICU stay, up to 24 weeks|||participants|||Number
774678|NCT00744380|Secondary|The Quality of Sedation (Assessed by the Riker Sedation-Agitation Score) and Analgesia (Assessed by the Pain Assessment Behavioral Score)|The Riker sedation-agitation score (range 1-7) and PABS (range 0-10) are assessed hourly by the bedside nurse. Riker scores assess restlessness and cooperation. Riker scores of 5 – 7 indicate agitation, 3 - 4 represent adequate sedation and 1 - 2 represent excessive sedation. PABS assessments include domains of restlessness, muscle tone, vocalization, consolability, and facial expressions. PABS assessments of 0 represent no pain, 1 - 3 represent mild pain, 4 - 6 represent moderate pain, and ≥ 7 represent severe pain.|Duration of ICU stay, for up to 24 weeks|||percentage of assessments while on study|||Number
774679|NCT00744380|Secondary|Cumulative Doses of Conventional Sedatives and Analgesics||Duration of ICU stay, for up to 24 weeks|||mg||Inter-Quartile Range|Median
774680|NCT00744380|Primary|Time From Study Drug Initiation to Tracheal Extubation||Duration of ICU stay, for up to 24 weeks|The analysis only includes patients successfully extubated for at least 72 hours. Eight subjects were excluded.||days||Inter-Quartile Range|Median
774681|NCT00744497|Other Pre-specified|Number of Participants With and Without Pericardial Effusion at Baseline and On-study and With Left Ventricular Ejection Fraction (LVEF) <40% and >=40% On-study|BL=baseline; OS=on-study|At baseline, approximately 12 weeks after start of treatment, and thereafter whenever clinically indicated|All participants who were randomized to receive any treatment||Participants|||Number
774682|NCT00744497|Other Pre-specified|Number of Participants With Changes From Baseline in Fridericia-corrected QTc Interval|QTc interval measured by electrocardiogram (ECG). Although a participant may have had several ECGs, only the longest QTc interval was included.|At baseline, approximately 12 weeks after starting treatment, and then whenever clinically indicated up to within 30 days of end of dosing|All participants who received treatment. n=number evaluable||Participants|||Number
774683|NCT00744497|Other Pre-specified|Number of Participants by Maximal On-study Fridericia-corrected QTc Interval|QTc interval measured by electrocardiogram (ECG). Although a participant may have had several ECGs, only the longest QTc interval was included.|At baseline, approximately 12 weeks after starting treatment, and then whenever clinically indicated up to within 30 days of end of dosing|All participants who received treatment. n=number evaluable||Participants|||Number
774684|NCT00744497|Other Pre-specified|Number of Participants With Abnormal Results in Urinalysis|Abnormal=positive, defined as the presence of >=30 mg/dL of protein; a small, moderate, or large amount of blood; or >0 g/dL glucose in urine. BL=baseline; neg=negative|At baseline, within 3 days prior to each infusion of docetaxel (each cycle), to end of treatment. If docetaxel is discontinued, every other cycle.|All participants who received treatment.||Participants|||Number
774685|NCT00744497|Other Pre-specified|Number of Participants With Abnormalities in Results of Clinical Laboratory Tests Assessing Liver Function, Renal Function, and Electrolytes|ALP=alkaline phosphatase; ALT=alanine aminotransferase; AST=aspartate aminotransferase; ULN=upper limit of normal. Abnormalities were graded according to the Common Toxicity Criteria (CTC), version 3.0, of the National Cancer Institute. CTC are graded from 1 (least severe) to 4 (life threatening). ALP, ALT, and AST, Grade 3, >5.0-20.0*ULN; Grade 4, >20.0*ULN. Total bilirubin, Grade 3, >3.0–10.0*ULN; Grade 4, >10.0*ULN. Creatinine, Grade 3, >3.0–6.0*ULN; Grade 4, >6.0*ULN. Hypercalcemia(serum calcium, mmol/L), Grade 3, >3.1-3.4; Grade 4, >3.4. Hypocalcemia (serum calcium, mmol/L), Grade 3, <1.75-1.5; Grade 4, <1.5. Hyperkalemia(serum calcium, mmol/L), Grade 3, >6.0-7.0; Grade 4, >7.0. Hypokalemia(serum calcium, mmol/L), Grade 3, <3.0-2.5; Grade 4, <2.5. Hypernatremia (serum calcium, mmol/L), Grade 3, >155-160; Grade 4, >160. Hyponatremia (serum sodium, mmol/L), Grade 3, <130-120; Grade 4, <120. Phosphorus (serum sodium, mmol/L), Grade 3, <0.6-0.3; Grade 4, <0.3.|At baseline, within 3 days prior to each infusion of docetaxel (each cycle), to end of treatment. If docetaxel is discontinued, every other cycle.|All participants who received treatment||Participants|||Number
774686|NCT00744497|Other Pre-specified|Number of Participants With Abnormalities in Results of Clinical Laboratory Tests in Hematology|Abnormalities were graded according to the Common Toxicity Criteria (CTC), version 3.0, of the National Cancer Institute. CTC are graded from 1 (least severe) to 4 (life threatening ). Grade 3 and 4 criteria are defined as follows: Absolute neutrophil count, Grade 3, neutrophils <1.0-0.5*10^9/L; Grade 4, <0.5*10^9/L. Hemoglobin, Grade 3, <4.9-4.0 mmol/L; Grade 4, <4.0 mmol/L. Platelets, Grade 3, <50.0-25.0*10^9/L; Grade 4, <25.0*10^9/L. Leukocytes, Grade 3, <2.0-1.0*10^9/L; Grade 4, <1.0*10^9/L.|At baseline, within 3 days prior to each infusion of docetaxel (each cycle) and at end of treatment. If docetaxel is discontinued, every other cycle.|All participants who received treatment||Participants|||Number
774687|NCT00744497|Other Pre-specified|Number of Participants With Drug-Related Adverse Events (AEs) of Special Interest|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. AEs of Special Interest=recognized events in other agents within this drug class or events for which safety data from nonclinical and clinical studies with dasatinib indicate that careful evaluation is warranted. Drug-related=having certain, probable, possible, or missing relationship to study drug. Drug-related AEs of Special Interest are identified by the medical and safety representatives of the sponsor based on MedDRA preferred terms or laboratory data. ANC=absolute neutrophil count.|Continuously throughout study to <=30 days after last dose of study drug; included AEs with an onset date >= day 1 and <= last dose date + 30 days|All participants who received treatment||Participants|||Number
774688|NCT00744497|Other Pre-specified|Number of Participants With Serious Adverse Event (SAEs), Drug-related SAEs, Drug-related AEs, Drug-related AEs Leading to Discontinuation, and All Deaths|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=having certain, probable, possible, or missing relationship to study drug|Continuously throughout study to <=30 days after last dose of study drug; included AEs with an onset date >= day 1 and <= last dose date + 30 days|All participants who received treatment||Participants|||Number
774689|NCT00744497|Secondary|Percentage of Participants With a Reduction in Pain Intensity From Baseline|The percentage of participants with a reduction in pain intensity from baseline was defined as the number of participants who achieved a 30% or more decrease in pain intensity from baseline for at least 2 consecutive pain assessments (at least 14 days apart) within 14 days of end of dosing divided by the number of randomized participants who had a baseline pain intensity of at least 2. Pain intensity was assessed based on question 3 of the brief pain inventory questionnaire.|At baseline, prior to each docetaxel infusion (every 3 weeks), at end of treatment, and at follow-up (within 14 days of end of dosing)|Participants with a baseline pain intensity of 2 or greater||Percentage of participants||95% Confidence Interval|Number
774690|NCT00744497|Secondary|Time to Prostate Specific Antigen (PSA) Progression|PSA progression is defined as the time from randomization to the date of the first PSA level measurement that led to confirmed PSA progression, for participants who had not started subsequent cancer therapy. For participants who did not progress or who progressed on cancer therapy, PSA progression is defined as the time from randomization to the date of the last PSA level measurement before the start of cancer therapy, if any. Participants who had no on-study PSA level measurements were censored on the day they were randomized.|From randomization to date of first PSA measurement leading to confirmed PSA progression (or to last bone scan assessment, if no progression or if cancer therapy started) (maximum reached: 30 months)|All participants who were randomized to receive any treatment||Months||95% Confidence Interval|Median
774691|NCT00744497|Secondary|Progression-free Survival (PFS)|PFS is defined as the time from the randomization date until the date of earliest evidence of disease progression or death, for participants who progressed or died before subsequent cancer therapy. Those who progressed or died while on subsequent cancer therapy and those who did not die or progress were censored at their last radiologic bone scan/imaging, skeletal related-event, or tumor assessment or at measurement of prostate specific antigen levels, whichever occurred last prior to start of subsequent cancer therapy ,if any. Participants with no assessments were censored on the day of randomization.|From day of randomization to disease progression or death (or to last clinical assessment, if subsequent cancer therapy started or no progression or death) (maximum reached: approximately 43 months)|All participants who were randomized to receive any treatment||Months||95% Confidence Interval|Median
774692|NCT00744497|Secondary|Percentage of Participants With A Reduction in Urinary N-telopeptide (uNTx) Level From Baseline|The percentage of participants who had an on-study uNTx value confirmed (at least 3 weeks later) within normal limits (or ≥3 and <60 nmol/mmol creatinine, if normal limits were missing) or an on-study uNTx level reduction from baseline of ≥35%, even when on-study uNTx value remained abnormal.|At baseline, prior to each docetaxel infusion (every 3 weeks) to end of treatment, at end of treatment, and at follow-up (within 14 days of end of dosing)|Participants who entered the study with baseline urinary N-telopeptide values higher than the upper limit of normal (ULN), or ≥60 nmol/mmol creatinine, if ULN was missing||Percentage of participants||95% Confidence Interval|Number
774693|NCT00744497|Secondary|Time to First Skeletal-related Event (SRE)|Time to first SRE is defined as the time in months from the date of randomization to the date of first SRE (unless SRE occurred while the patient was undergoing subsequent cancer therapy). Participants with a first SRE while on subsequent cancer therapy, those who died without a reported SRE, and those who did not have an SRE were censored on the date of their last SRE assessment prior to start of subsequent cancer therapy, if any. Participants who had no SRE assessments were censored on the day they were randomized.|From day of randomization to date of first SRE or to last SRE assessment, if subsequent cancer therapy begun or no SRE (maximum reached: 42 months)|All participants who were randomized to receive any treatment||Months||95% Confidence Interval|Median
774694|NCT00744497|Secondary|Percentage of Participants With an Objective Tumor Response by Modified Response Evaluation Criteria in Solid Tumors (RECIST)|Objective tumor response rate=the percentage of randomized participants with a best tumor response of partial (PR) or complete response (CR), within 42 days of end of dosing, divided by total number of patients who were evaluable (with at least 1 target lesion at baseline). By RECIST: CR=disappearance of clinical and radiologic evidence of target and nontarget lesions confirmed by another evaluation at least 6 weeks later. PR=a >30% or greater decrease in the sum of longest diameter (LD) of target lesions in reference to the baseline sum LD confirmed by another evaluation at least 6 weeks later. Stable disease=neither sufficient increase to qualify for PD nor shrinkage to qualify for PR, and at least 8 weeks since start of study therapy. Progressive disease=a 20% or greater increase in sum of LD of all target lesions, taking as reference the smallest sum of LD at or following baseline, or unequivocal progression on existing nontarget lesions, or new lesions are present.|At baseline and every 12 weeks thereafter to end of treatment, at end of treatment, and at follow-up (within 42 days of end of dosing)|Participants with at least 1 target lesion at baseline||Percentage of participants||95% Confidence Interval|Number
774695|NCT00744497|Primary|Overall Survival: Time From Randomization to Date of Death|Overall survival is defined as time in months from the randomization date to the date of death due to any cause (in the randomized population). If the patient did not die, survival was censored on the last date he or she was known to be alive.|From randomization to death or date of last contact (maximum reached: 45 months)|All participants who were randomized to receive any treatment||Months||95% Confidence Interval|Median
774696|NCT00744523|Secondary|Access Site Adverse Events|Number of subjects with adverse events at the percutaneous access site as a result of the index procedure, including bruising, hematoma and bleeding requiring treatment by transfusion of blood products, surgical repair, ultrasound compression or thrombin injection.|Index Procedure through Hospital Discharge|||participants|||Number
774699|NCT00744523|Secondary|Procedural Success|"Number of subjects with technical success without the occurrence of any MACCE or unresolved antegrade flow blockage intolerance during the index hospitalization.
Note: Three subjects were missing final angiographic results and therefore Technical and Procedural success could not be defined for these three subjects, thereby, decreasing the number of participants analyzed from 225 to 222."|The entire duration of the index procedure through hospital discharge|||participants|||Number
774700|NCT00744523|Secondary|Technical Success|"Number of subjects with device success and the ability to successfully implant a carotid stent and obtain a residual stenosis < 30% during the index procedure(as evaluated by the angiographic core laboratory).
Note: Three subjects were missing final angiographic results and therefore Technical and Procedural success could not be defined for these three subjects, thereby, decreasing the number of participants analyzed from 225 to 222."|The entire duration of the index procedure|Roll-In participants were analysed on the number of roll-in cases performed. Pivotal subjects were analysed as Intention To Treat (ITT).||participants|||Number
774701|NCT00744523|Secondary|Device Success|Number of subjects in which the MO.MA was able to be positioned, deployed, and retrieved intact during the index procedure.|The entire duration of the index procedure|Roll In Population - All subjects enrolled prior to the pivotal phase at each US site. Pivotal - All subjects who fulfilled the eligibility criteria who were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA device. ITT - All subjects enrolled regardless of subsequent treatment.||participants|||Number
774702|NCT00744523|Primary|Major Adverse Cardiac and Cerebrovascular Events (MACCE) Within 30 Days of the Procedure.|Number of subjects with one or more Major Adverse Cardiac and Cerebrovascular Events through 30 days after the procedure. MACCE are defined as: any myocardial infarction (MI), stroke, or death through day 30 post-procedure.|Up to 30 days after the procedure was performed|Roll In Population - All subjects enrolled prior to the pivotal phase at each US site. Pivotal - All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA device. ITT - All subjects enrolled regardless of subsequent treatment.||participants|||Number
774703|NCT00744627|Secondary|Health Care Resource Utilization as Assessed by the Health Economic Assessment Questionnaire|Healthcare resource utilization was assessed by the Health Economic Assessment (HEA) questionnaire, which monitors the participants absenteeism from work, as well as resource use such as visits to a general practitioner, outpatient and inpatient services, hospitalization, medications, and other relevant services over the past 8 weeks.|Baseline and Week 8|Full analysis set.||participants|||Number
774704|NCT00744627|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Mental Health Subscore at Each Week Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The mental health sub-score assesses general mental health (psychological distress and well-being) and ranges from 0 (best) - 100 (worst). LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 2, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
774705|NCT00744627|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Emotional Subscore at Each Week Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The role-emotional subscale assesses limitations in usual role activities because of emotional problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 2, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
774706|NCT00744627|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Vitality Subscore at Each Week Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The vitality sub-score assesses energy and fatigue, and ranges from 0 (best) - 100 (worst). LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 2, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
774707|NCT00744627|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Subscore at Each Week Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The general health sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 2, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
774708|NCT00744627|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Bodily Pain Subscore at Each Week Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The bodily pain sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 2, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
775212|NCT00755222|Primary|Change From Baseline in PDQ Intercourse Contraint|"Peyronie's disease intercourse contraint Scale: 0-12 lower numbers reflect 'less intercourse contraint'; higher numbers reflect 'more intercourse constraint'
Change from baseline equals Week 36 minus baseline. Negative change reflects improvement in the intercourse constraint scale."|Baseline to Week 36 or LOCF|||scores on a scale||Standard Deviation|Mean
774709|NCT00744627|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Physical Subscore at Each Week Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The role-physical subscale assesses limitations in usual role activities because of physical health problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 2, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
774710|NCT00744627|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Physical Functioning Subscore at Each Week Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The physical functioning subscale assesses limitations in physical activities because of health problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 2, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
774711|NCT00744627|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Other Weeks Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The social functioning subscale assesses limitations in social activities because of physical or emotional problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 2 and 4|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
774712|NCT00744627|Secondary|Change From Baseline in the Hospital Anxiety and Depression (HAD) Depression Subscale at Each Week Assessed|The HAD-Depression subscale is completed by the participant and measures depression, focusing on the state of lost interest and diminished pleasure response. The subscale is made up of 7 items that are assessed on a scale from 0 (no depression) to 3 (severe feeling of depression). Participants are required to indicate the response which most accurately reflects the way they have felt over the last few days. The item scores are summed and the total subscore ranges from 0 to 21 (maximal severity). LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 1, 4 and 8|"The Full Analysis Set. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
774713|NCT00744627|Secondary|Change From Baseline in Clinical Global Impression Scale-Severity of Illness at Each Week Assessed|The Clinical Global Impression-Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 1, 2, 4, 6 and 8|"Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
774714|NCT00744627|Secondary|Percentage of Participants in HAM-A Remission at Each Week Assessed|Remission is defined as a Hamilton Anxiety Scale (HAM-A) total score ≤ 7. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity).|Weeks 1, 2, 4, 6 and 8|"Full analysis set; Last observation carried forward was used. n indicates the number of patients included in the analysis at each time point."||percentage of participants|||Number
774715|NCT00744627|Secondary|Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed in Participants With Baseline HAM-A ≥25|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 1, 2, 4 and 6|"Full analysis set patients with a HAM-A Baseline score ≥25. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
774716|NCT00744627|Secondary|Percentage of Responders in HAM-A Total Score at Other Weeks Assessed|Response was defined as participants with a ≥ 50% decrease from Baseline in the Hamilton Anxiety Scale (HAM-A) total score. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity).|Baseline and Weeks 1, 2, 4 and 6|"Full analysis set; Last observation carried forward was used. n indicates the number of patients included in the analysis at each time point."||percentage of participants|||Number
774717|NCT00744627|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Other Weeks Assessed|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 1, 2 and 4|"Full analysis set where Baseline data were available. A mixed model for repeated measurements (MMRM) based on observed cases was used. n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
774718|NCT00744627|Secondary|Clinical Global Impression Scale-Global Improvement at Other Weeks Assessed|The Clinical Global Impression-Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 1, 2, 4 and 6|"Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
774719|NCT00744627|Secondary|Change From Baseline in the Hospital Anxiety and Depression (HAD) Anxiety Subscale at Other Weeks Assessed|The Hospital Anxiety and Depression (HAD) Anxiety sub-scale consists of 7 items that are assessed on a scale from 0 (no anxiety) to 3 (severe feeling of anxiety). The anxiety subscale determines a state of generalized anxiety including anxious mood, restlessness, anxious thoughts and panic attacks. Scores are summed and range from 0 to 21 (maximal severity). LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 1 and 4|"The Full Analysis Set. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
774720|NCT00744627|Secondary|Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 1, 2, 4 and 6.|"The Full Analysis Set. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
774721|NCT00744627|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Week 8|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The social functioning subscale assesses limitations in social activities because of physical or emotional problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Week 8|The Full Analysis Set. A mixed model for repeated measurements (MMRM) based on observed cases was used.||scores on a scale||Standard Error|Least Squares Mean
774722|NCT00744627|Secondary|Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8 in Participants With Baseline HAM-A ≥25|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Week 8|Full analysis set patients with a HAM-A Baseline score ≥25. A mixed model for repeated measurements (MMRM) based on observed cases was used.||scores on a scale||Standard Error|Least Squares Mean
774723|NCT00744627|Secondary|Percentage of Responders in HAM-A Total Score at Week 8|Response was defined as participants with a ≥ 50% decrease from Baseline in the Hamilton Anxiety Scale (HAM-A) total score. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity).|Baseline and Week 8|Full analysis set; Last observation carried forward was used.||percentage of participants|||Number
774724|NCT00744627|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Week 8|Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.||scores on a scale||Standard Error|Least Squares Mean
774757|NCT00751114|Secondary|Number of Patients With at Least One Episode of Severe Symptomatic Hypoglycemia|Severe symptomatic hypoglycemia was defined as an event with clinical symptoms which required assistance of another person and with either a Plasma Glucose level < 36 mg/dL (2 mmol/L) or with a prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration|During the treatment phase (24 weeks) plus 7 days after last dose|The population analyzed for this outcome measure was the safety population (treated patients)||participants|||Number
774725|NCT00744627|Secondary|Clinical Global Impression Scale-Global Improvement at Week 8|The Clinical Global Impression-Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from a MMRM with baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Week 8|Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.||scores on a scale||Standard Error|Least Squares Mean
774726|NCT00744627|Secondary|Change From Baseline in the Hospital Anxiety and Depression (HAD) Anxiety Subscale at Week 8|The Hospital Anxiety and Depression (HAD) Anxiety sub-scale consists of 7 items that are assessed on a scale from 0 (no anxiety) to 3 (severe feeling of anxiety). The anxiety subscale determines a state of generalized anxiety including anxious mood, restlessness, anxious thoughts and panic attacks. Scores are summed and range from 0 to 21 (maximal severity). LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Week 8|Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.||scores on a scale||Standard Error|Least Squares Mean
774727|NCT00744627|Primary|Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Least Squares (LS) means were from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Week 8|The Full Analysis Set included all patients who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline value for assessment of primary efficacy. A mixed model for repeated measurements (MMRM) based on observed cases was used.||scores on a scale||Standard Error|Least Squares Mean
774728|NCT00749996|Secondary|To Demonstrate a Statistically Significant Difference in the Reduction of Disability Between Both Treatment Groups. The Endpoint Will be the Difference Between Baseline and 12 Months of the Patient's Score on the Oswestry Disability Index (ODI).|"The endpoint will be the difference between baseline and 12 months of the patient's score on the Oswestry Disability Index (ODI).
The ODI is a low back pain disability questionnaire used to measure a patient’s permanent functional disability in a scale from 0 to 50 (when all the 10 sections are answered); large ODI scores indicate large disability."|12 Months|||patient's score||Standard Deviation|Mean
774729|NCT00749996|Primary|To Demonstrate a Statistically Significant Difference in the Relief of Back Pain Between Both Treatment Groups. The Endpoint Will be the Difference Between Baseline and 6-month of the Patient's Back-pain Score on a Visual Analogue Scale (VAS).|The endpoint will be the difference between baseline and 6 months of the patient's back-pain score on a Visual Analogue Scale (VAS). A standardized visual analogue scale (0cm-10cm; with 0cm meaning ‘no pain’ and 10cm meaning ‘worst possible pain’) will be used. Large values of the VAS score represent large degree of pain. Large (negative) change in VAS score (6 months - baseline) represents large relief of pain. For treated subjects, all analyses except the safety analyses, Intent-To-Treat population will serve as the primary analysis dataset.|6 Months|||units on a scale||Standard Deviation|Mean
774730|NCT00750061|Secondary|Changes in Functional Independence Measure (FIM) Motor Subscale and Visual Analog Scale (VAS) for Pain|Changes from Baseline to Week 6 and Month 6 in Functional Independence Measure (FIM) motor subscale (0 ~ 91, the higher the better), Visual Analog Scale (VAS) for pain (0 ~ 100, the less the better)|6 months|Full Analysis Set||units on a scale||Standard Deviation|Mean
774731|NCT00750061|Primary|Changes of Neurological Scores for Baseline|Changes of Motor Scores (0 ~ 100), Pin Prick Scores (0 ~ 112) and Light Touch Scores (0 ~ 112) from Baseline to Week 6 and Month 6. The higher the changes the better the functional improvement.|6 months|Full Analysis Set||units on a scale||Standard Deviation|Mean
774732|NCT00750139|Secondary|Percentage of Subjects With Mycological Cure and Percentage of Subjects With Treatment Effectiveness at Week 6|Mycological Cure was defined as negative KOH result and negative dermatophyte culture at Week 6. Treatment Effectiveness was defined as negative KOH, negative culture, and Scaling, Erythema, and Pruritus grades of 0 or 1 at Week 6.|Week 6|This was the Full Analysis Set (FAS) comprising of subjects in the Safety Evaluation Set (SES) with a positive culture at baseline for whom the primary efficacy variable was available. This was a Modified Intent to Treat (MITT) principle because the culture results were not available at the start of treatment.||percentage of Subjects|||Number
774733|NCT00750139|Primary|Percentage of Subjects With Complete Cure at Week 6.|"The first primary efficacy variable was the percentage of subjects in the NAFT-500 Cream, 2% or 2-week placebo groups with complete cure at Week 6.
The second primary efficacy variable was the percentage of subjects in the Naftin 1% Cream or 4-week placebo groups with complete cure at Week 6.
Complete cure was defined as negative mycology results from the central laboratory (dermatophyte culture and KOH) and absence of erythema, scaling, and pruritus that were evaluated using a 4 point severity scale."|Week 6|This is based on the Full Analysis Set (FAS). The FAS is the subset of all subjects in the Safety Evaluation Set (SES) with a positive culture at baseline for whom the primary efficacy variable is available. This is a modified intent to treat (MITT) principle because the culture results will not be available before the start of treatment.||percentage of subjects with complete cur|||Number
774734|NCT00750152|Secondary|Mycological Cure and Treatment Effectiveness|Mycological Cure was defined as negative KOH result and negative dermatophyte culture at Week 4. Treatment Effectiveness as defined as negative KOH, negative culture, and Scaling, Erythema and Pruritis grades of 0 or 1 at Week 4.|Week 4 (two weeks post-treatment)|This is the Full Analysis Set (FAS)comprising of subjects in the SES with a positive culture at Baseline for whom the primary efficacy variable was available. This was a modified intent to treat principle because the culture results were not available before the start of treatment.||percentage of subjects|||Number
775213|NCT00755222|Primary|Change From Baseline in Peyronie's Disease Questionnaire (PDQ) Peyronie’s Disease Symptom Bother|"Peyronie's disease Symptom Bother Scale: 0-20 lower numbers reflect 'less symptom bother'; higher numbers reflect 'more symptom bother'
Change from baseline equals Week 36 minus baseline. Negative change reflects improvement in the symptom bother scale."|Baseline to Week 36 or LOCF|||scores on a scale||Standard Deviation|Mean
774735|NCT00750152|Primary|Percentage of Subjects|Complete cure is defined as negative mycology results from the central laboratory (dermatophyte culture and KOH) and absence of Erythema, Scaling, and Pruritus (grade 0 for each) evaluated using the 5-point severity grading scale: 0 = absent, 1 = mild, 2 = moderate, 3 = marked, and 4 = not done.|Week 4 post-baseline|The Full Analysis Set (FAS)is the subset of all subjects in the Safety Evaluation Set (SES)with a positive culture at baseline and for whom the primary efficacy variable is available. This is a modified intent-to-treat (MITT) principle because the culture results were not available before the start of treatment.||percentage of subjects with complete cur|||Number
774736|NCT00750191|Other Pre-specified|Opioid Usage|Patient reported Opioid usage (converted to morphine equivalents)|6 months|||mg||Standard Deviation|Mean
774737|NCT00750191|Secondary|Disability|Disability as measured by the Oswestry Disability Index. Scale range: 0 (minimum: best outcome) to 100 (maximum: worst outcome)|6 months|||units on a scale||Standard Deviation|Mean
774738|NCT00750191|Secondary|Pain|Pain level as measured by the Numerical Rating Scale. Scale range: 0 (minimum: best outcome) to 10 (maximum: worse outcome)|6 months|||units on a scale||Standard Deviation|Mean
774739|NCT00750191|Primary|Physical Function|"Physical function as measured by the Short Form (36) Health Survey questionnaire physical function component.
Scale range for physical function component: 0 (minimum: worse outcome) to 100 (maximum: best outcome)."|6 months|||units on a scale||Standard Deviation|Mean
774740|NCT00750204|Primary|Amount of Sedatives Used||48 hours|Data was not collected for this outcome measure, as the study was terminated prematurely.|||||
774741|NCT00750269|Secondary|Rate of Late Toxicity (i.e., Occurs > 1 Year After the Start of SBRT) of ≥ Grade 3 as Assessed by NCI CTCAE v4.0|Percentage of patients who developed any treatment-related toxicity after the first year following the start of SBRT.|From start of treatment to end of follow-up. Analysis occurs after all patients have been potentially followed for 24 months, approximately 7.5 years from the start of the study.|All eligible patients who started study treatment who were observed more than 1 year after start of SBRT||percentage of participants||95% Confidence Interval|Number
774742|NCT00750269|Secondary|Rate of Toxicity ≥ Grade 3 (Other Than DLT) Within One Year as Assessed by NCI CTCAE v4.0|Rate of patients developing any treatment-related toxicity during the first year following the start of SBRT that is not among the types considered as a dose-limiting toxicity.|From start of SBRT until 1 year.|All eligible patients who started study treatment||percentage of participants||95% Confidence Interval|Number
774743|NCT00750269|Secondary|Distant Metastases|Distant metastases is defined as the appearance after protocol therapy of cancer deposits characteristic of metastatic dissemination from non-small cell lung cancer. Distant metastases progression was assessed using the cumulative incidence method to estimate the 2-year failure rate. Arms were not compared/tested.|From randomization to date of death, distant failure or last follow-up. Analysis occurs after all patients have been potentially followed for 24 months, approximately 7.5 years from the start of the study.|All eligible patients who started study treatment||percentage of participants||95% Confidence Interval|Number
774744|NCT00750269|Secondary|Nodal Progression|Regional nodal progression is defined as appearance after protocol therapy of measurable tumor within lymph nodes along the natural lymphatic drainage typical for the location of the treated primary disease only with dimension of at least 1.0 cm on imaging studies (preferably CT scans) within the lung, bronchial hilum, or the mediastinum. Regional nodal progression was assessed using the cumulative incidence method to estimate the 2-year failure rate. Arms were not compared/tested.|From randomization to date of death, regional failure or last follow-up. Analysis occurs after all patients have been potentially followed for 24 months, approximately 7.5 years from the start of the study.|All eligible patients who started study treatment||percentage of patients||95% Confidence Interval|Number
774745|NCT00750269|Secondary|Local Progression|Local progression is the same as primary tumor failure (PTF) which refers to the primary treated tumor after protocol therapy and corresponds to meeting both of the following two criteria: 1) Increase in tumor dimension of 20% as defined above for local enlargement (LE); 2) The measurable tumor with criteria meeting LE should be avid on Positron Emission Tomography (PET) imaging with uptake of a similar intensity as the pretreatment staging PET, OR the measurable tumor should be biopsied confirming viable carcinoma. For outcome analysis, Marginal Failures (MF) and Involved Lobe Failures will also be counted as PTF. Local progression was assessed using the cumulative incidence method to estimate the 2-year failure rate. Arms were not compared/tested.|From randomization to date of death, regional failure or last follow-up. Analysis occurs after all patients have been potentially followed for 24 months.|All eligible patients who started study treatment||percentage of participants||95% Confidence Interval|Number
774746|NCT00750269|Secondary|Overall Survival|An event for overall survival is death due to any cause. Overall survival was assessed at the maximum tolerated dose using the Kaplan-Meier method to estimate the 2-year survival rate. Arms were not compared/tested.|From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 24 months, approximately 7.5 years from the start of the study.|All eligible patients who started study treatment||percentage of participants||95% Confidence Interval|Number
774747|NCT00750269|Secondary|Progression-free Survival|Progression-free survival is defined as the state of being alive without progression of disease. A failure is the first of the following: local progression, regional progression, distant metastasis, or death. Progression-free survival was assessed at the maximum tolerated dose using the Kaplan-Meier method to estimate the 2-year survival rate. Arms were not compared/tested.|From randomization to date of death, failure (local, regional or distant) or last follow-up. Analysis occurs after all patients have been potentially followed for 24 months, approximately 7.5 years from the start of the study.|All eligible patients who started study treatment||percentage of participants||95% Confidence Interval|Number
774758|NCT00751114|Secondary|Number of Patients With at Least One Episode of Symptomatic Hypoglycemia|Symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemia confirmed or not by a plasma glucose measurement <= 70mg/dL [3.9 mmol/L]|During the treatment phase (24 weeks) plus 7 days after last dose|The population analyzed for this outcome measure was the safety population (treated patients)||participants|||Number
775214|NCT00755222|Primary|Change From Baseline in Penile Curvature|Negative change reflects improvement in penile curvature|Baseline and Week 36 or last observation carried forward (LOCF)|||Percent change from baseline||Standard Deviation|Mean
774748|NCT00750269|Primary|(Phase II) Primary Tumor Control Rate at the Maximum Tolerated Dose (MTD)|Primary tumor control is defined as the absence of primary tumor failure. Primary tumor failure (PTF) refers to the primary treated tumor after protocol therapy and corresponds to meeting following two criteria: 1) Increase in tumor dimension of 20% as defined above for local enlargement (LE); 2) The measurable tumor with criteria meeting LE should be avid on Positron Emission Tomography (PET) imaging with uptake of a similar intensity as the pretreatment staging PET, OR the measurable tumor should be biopsied confirming viable carcinoma. Marginal Failures (MF) and Involved Lobe Failures were also counted as PTF. The cumulative incidence method was used to estimate primary tumor control rate. The 90% confidence interval for local control was calculated using bootstrapping methods. Per the protocol, only the MTD dose level was to be analyzed. However, due to the quantity of patients enrolled on Dose Level 8 as well as safety concerns, Dose Level 8 was analyzed also.|From start of SBRT to 2 years.|All eligible patients who started study treatment||percentage of participants||90% Confidence Interval|Number
774749|NCT00750269|Primary|(Phase I) Maximum Tolerated Dose of Stereotactic Body Radiotherapy (SBRT) as Assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v4.0|Maximum tolerated dose (MTD) defined as dose most closely associated with a 20% probability of experiencing a toxicity <= 1 year from start of SBRT from following dose-limiting toxicities: Gr 3-5 Cardiac: Pericardial effusion, Pericarditis, Restrictive cardiomyopathy; Gr 4-5 GI: Dysphagia, Esophagitis, Esophageal fistula/obstruction/perforation/stenosis/ulcer/hemorrhage; Gr 3-5 Nervous System Disorders: Brachial plexopathy, Recurrent laryngeal nerve palsy, Myelitis; Gr 3-5 Respiratory: Atelectasis (gr 4-5 only), Bronchopulmonary/mediastinal/pleural/tracheal hemorrhage, Bronchial/pulmonary/bronchopleural/tracheal fistula, Hypoxia (provided gr 3 is worse than baseline), Bronchial/tracheal obstruction, Pleural effusion, Pneumonitis, Pulmonary fibrosis; Changes in Pulmonary Function Tests per SBRT Pulmonary Toxicity Scale, Gr 3-5: FEV1 decline, FVC decline; Any Gr 5 adverse event attributed to treatment. Dose level was determined by time-to-event continual reassessment method (TITE-CRM).|From start of SBRT to 1 year|All eligible patients who started study treatment||Gy/FX|||Number
774750|NCT00750282|Secondary|Standard Uptake Value Ratios for Florbetaben Signal|The Standard Uptake Value Ratios for florbetaben signal in the frontal cortex, lateral temporal cortex, parietal cortex, anterior cingulate, posterior cingulate cortex, occipital cortex, and cerebellum (white matter) were determined as a quantitative measure of tracer uptake. The SUV is defined as the ratio of (1) the tissue radioactivity concentration c (in MBq/kg) at time point t, and (2) the injected activity (in MBq, extrapolated to the same time t) divided by the body weight (in kg). These SUV numbers from regions of interest were then used to derive SUV ratios (SUVR) using the SUV from the cerebellar cortex as reference.)|90-110 min post injection|All subjects who had PET imaging data and did not have a major protocol violation were included in the analysis||ratio||Standard Deviation|Mean
774751|NCT00750282|Secondary|Kappa Coefficient as a Measure of Agreement Between Readers Concerning the Visual Assessment of Abnormality of the Brain Scan (Based on BAPL Score)|The agreement between 3 blinded readers concerning the visual assessment of abnormality of the brain scan (based on BAPL score) was measured by the kappa coefficient. Kappa values close to 1.0 indicate a high agreement while values close to 0 indicate random agreement.|45-60 min, 90-110 min, 110-130 min|All subjects who had PET imaging data and did not have a major protocol violation were included in the analysis||Kappa coefficient|||Number
774752|NCT00750282|Secondary|Sensitivity and Specificity for All Participants Using Two Additional Imaging Windows for the Visual Assessment|PET scans from two additional imaging windows (45-60 min and 110-130 min) were visually assessed|45 - 60 min and 110 - 130 min after IMP injection|All subjects who had PET imaging data and did not have a major protocol violation were included in the analysis||percentage of subjects||95% Confidence Interval|Number
774753|NCT00750282|Primary|Specificity and Sensitivity of Florbetaben PET Scans Obtained in Part B Using Two Separate Algorithms and the Onsite Clinical Diagnosis as the Standard of Truth.|"Part B: For the calculation of sensitivity/specificity, a patient with probable AD was expected to have a positive florbetaben PET scan, ie,abnormal scan (BAPL scores “2 or 3”) which was considered a match for sensitivity. A HV was expected to have a negative florbetaben PET scan, ie,normal scan (BAPL score “1) which was considered a match for specificity.
The clinical diagnosis was established by an independent consensus panel (CP) of experts in dementia.
Two independent sets of PET data reads were performed. The first set was performed by a panel of three readers who received live, instructor-led training on the visual assessment procedure. The second set was performed by a panel of five separate readers who were trained on the visual assessment procedure with electronic media."|90 - 110 min after IMP injection|All subjects who had PET imaging data and did not have a major protocol violation were included in the analysis||percentage of subjects||95% Confidence Interval|Number
774754|NCT00750282|Primary|Specificity and Sensitivity of Florbetaben PET Scans Obtained in Part A Using Two Separate Algorithms and the Onsite Clinical Diagnosis as the Standard of Truth|"Part A: For the calculation of sensitivity/specificity, a patient with probable AD was expected to have a positive florbetaben PET scan which was considered a match for sensitivity. A HV was expected to have a negative florbetaben PET scan which was considered a match for specificity. Standard of truth was the onsite clinical diagnosis.
Two Beta-Amyloid Plaque Load (BAPL) algorithms for assessing the normality/abnormality of beta-amyloid plaque load in the brain scans were used.
Using algorithm A (Majority Read), a brain scan of a subject with a BAPL score of “1” (without beta-amyloid plaque load) or “2” (with minor beta-amyloid plaque load) was considered normal and a BAPL score of “3” (with significant beta-amyloid plaque load) was considered abnormal.
Using algorithm B (Average), a brain scan of a subject with a BAPL score of “1” was considered normal and a brain scan with a BAPL score of “2” or “3” was considered abnormal. Algorithm B was used in Part B and in the final"|90 - 110 min after investigational medical product (IMP) injection|All subjects who had PET imaging data and did not have a major protocol violation were included in the analysis.(n=146)||percentage of subjects||95% Confidence Interval|Number
774755|NCT00750308|Primary|Insulin Sensitivity|As assessed using IV glucose tolerance test and calculated using Min Mod units mU/mm|three weeks|Those who completed protocol||(mU/L)-1x(min)-1xL||Standard Error|Mean
774756|NCT00750308|Primary|Beta Cell Function|Beta cell function as measured during a frequently sampled IV glucose tolerance test|3 hours|||microU/mM||Standard Error|Mean
774802|NCT00751530|Primary|Percentage of Participants With Viral Load < 400 Copies /mL at Week 12.|The HIV RNA (viral load) was measured using standard of care testing via local laboratories.|12 Weeks|||Percentage of Participants|||Number
774759|NCT00751114|Secondary|Change in Body Weight From Baseline to Study Endpoint||baseline (week 0), study endpoint: visit 14 (week 24) or visit 12 (week 16) or visit 11 (week 12) or visit 8 (week 6) depending on last available value|"The population analyzed for this outcome measure consisted of the subset of the safety population (treated patients) who had both baseline and endpoint measurements.
Adjusted means were estimated from ANCOVA model using baseline value as covariate."||kg||Standard Error|Least Squares Mean
774760|NCT00751114|Secondary|Lipid Profile: Change From Baseline to Study Endpoint||baseline (week 0), study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14|"The population analyzed for this outcome measure consisted of the subset of mITT patients who had both baseline and endpoint measurements.
Adjusted means were estimated from ANCOVA model using baseline value as covariate."||mg/dL||Standard Error|Least Squares Mean
774761|NCT00751114|Secondary|Insulin Dose in the Insulin Glargine Group|Daily dose at the face-to-face visits.|visit 4 (week 2), visit 8 (week 6), visit 11 (week 12), visit 12 (week 16), visit 14 (week 24), first dose received defined as first available value, study endpoint defined as last available value|The population analyzed for this outcome was the safety population defined as randomized patients who received at least one dose of investigational product.||unit per kg body weight||Standard Deviation|Mean
774762|NCT00751114|Secondary|7-point Plasma Glucose Profile: Change From Baseline to Study Endpoint|"7-point plasma glucose recorded before and after breakfast, before and after lunch, before and after dinner and at bedtime.
Change = study endpoint - baseline."|baseline (week 0), study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14|"The population analyzed for this outcome measure consisted of the subset of mITT patients who had valid 7-point plasma glucose profiles (4 points needed for a valid profile) both at baseline and endpoint.
Depending on the time point, few values were missing.
Adjusted means were estimated from ANCOVA model using baseline value as covariate."||mg/dL||Standard Error|Least Squares Mean
774763|NCT00751114|Secondary|Self-monitored Fasting Plasma Glucose (SMFPG) Mean : Change From Baseline to Study Endpoint|"SMFPG mean = mean of the fasting plasma glucose values recorded on the 6 consecutive days before the visit (at least 3 values needed).
Study endpoint was defined as the last available SMFPG mean value collected on-treatment.
Change= study endpoint - baseline"|baseline (week 0), study endpoint: visit 14 (week 24) or visit 12 (week 16) or visit 11 (week 12) or visit 8 (week 6) depending on last available value|"The population analyzed for this outcome measure consisted of the subset of mITT patients who had both baseline and endpoint measurements.
Adjusted means were estimated from ANCOVA model using baseline value as covariate."||mg/dL||Standard Error|Least Squares Mean
774764|NCT00751114|Secondary|HbA1c Response Rate: Percentage of Patients Who Reach the Target of HbA1c < 6.5% at Study Endpoint||study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14|The population analyzed for this outcome measure consisted of the subset of mITT patients who had endpoint measurements.||percentage of participants|||Number
774765|NCT00751114|Secondary|HbA1c Response Rate: Percentage of Patients Who Reach the Target of HbA1c < 7% at Study Endpoint||study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14|The population analyzed for this outcome measure consisted of the subset of mITT patients who had endpoint measurements.||percentage of participants|||Number
774766|NCT00751114|Primary|HbA1c: Change From Baseline to Study Endpoint|Change in HbA1c from baseline to study endpoint defined as the last available HbA1c value measured during the 24-week treatment period.|baseline (week 0), study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14|"The population analyzed for this outcome measure consisted of the subset of mITT patients who had both baseline and endpoint measurements.
The Last Observation Carried Forward method was used for imputing missing data for the end of treatment value."||percent||Standard Error|Least Squares Mean
774767|NCT00751140|Secondary|Surgical Outcomes: Mean Lymph Node Count|The mean (range) total lymph node count and lymph node count per procedure category. Between 2009 and 2011, patients with suspected upper urinary tract urothelial carcinoma (UUT-UC) underwent open, laparoscopic, or robot-assisted radical nephroureterectomy (RNU) with modified retroperitoneal lymph node dissection (RPLND).|2 years|Total Participants and Participants Per Procedure Category||Lymph Nodes||Full Range|Mean
774768|NCT00751140|Primary|Number of Participants With Pathologically Proven Lymph Node Metastasis|"The number of participants having pathologically proven lymph node metastasis at the time of radical nephroureterectomy (RNU) and modified retroperitoneal lymph node dissection (RPLND).
The primary endpoint is the detection via lymph node dissection of pathological node positive urothelial carcinoma in patients treated with open or laparoscopic nephroureterectomy for upper tract urothelial cancer."|Up to 4 years|All evaluable participants. On histopathological review, one patient had a benign angioma and was excluded from the final data analysis.||participants|||Number
774769|NCT00751179|Secondary|Time to Recovery of T1 to 90% of Baseline Following Neuromuscular Blockade Induced by Succinylcholine|Neuromuscular functioning was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until recovery of T1 of 90% of baseline and full recovery of neuromuscular function occurred as determined by the anesthesiologist as per routine clinical practice.|Start of administration of succinylcholine to recovery from neuromuscular blockade (Up to approximately 18 minutes)|Participants who received succinylcholine and had evaluable neuromuscular function data determined to be reliable by a central independent adjudication committee.||Minutes||95% Confidence Interval|Geometric Mean
774770|NCT00751179|Secondary|Time to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9 Following Administration of 4.0 mg/kg of Sugammadex After Neuromuscular Blockade Induced by Rocuronium|Neuromuscular functioning was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.9. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade, with a value of 1.0 representing full recovery.|Start of administration of sugammadex to recovery from neuromuscular blockade (Up to approximately 6 minutes)|Participants who received both rocuronium and sugammadex and had evaluable neuromuscular function data determined to be reliable by a central independent adjudication committee.||Minutes||95% Confidence Interval|Geometric Mean
775215|NCT00755235|Secondary|Treatment Satisfaction|"Single item seven point scale ranging from very satisfied to very dissatisfied"|Measured after 6 months of treatment|||participants|||Number
774771|NCT00751179|Secondary|Number of Participants With at Least One Adverse Event (AE) in Rocuronium - Sugammadex and Succinylcholine Treatment Groups|"Only AEs which occurred following administration of sugammadex or succinylcholine are included. AEs in the rocuronium - sugammadex group occurring after rocuronium but before sugammadex administration are considered pretreatment events and are not included. The AE reporting interval included the entire intubation/surgical period for the succinylcholine group (since succinylcholine was administered just prior to intubation/commencement of surgery) but not for the rocuronium - sugammadex group (since sugammadex was administered at the end of the surgical procedure)."|Up to 7 days post dose|Participants who received sugammadex or succinylcholine.||participants|||Number
774772|NCT00751179|Primary|Change From Baseline in Plasma Potassium Levels at 5 Minutes After Treatment With Sugammadex|"Change from baseline = 5 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium dose. Only data post sugammadex dose are included for rocuronium - sugammadex group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period)."|Baseline and 5 minutes post dose|Participants who received sugammadex with evaluable (i.e., not missing or hemolyzed) blood samples for potassium measurement at baseline and at the 5 minute post-dose time point.||mmol/L||Standard Deviation|Mean
774773|NCT00751179|Secondary|Change From Baseline in Plasma Potassium Levels at 15 Minutes After Treatment With Sugammadex|"Change from baseline = 15 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium dose. Only data post sugammadex dose are included for rocuronium - sugammadex group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period)."|Baseline and 15 minutes post dose|Participants who received sugammadex with evaluable (i.e., not missing or hemolyzed) blood samples for potassium measurement at baseline and at the 15 minute post-dose time point.||mmol/L||Standard Deviation|Mean
774774|NCT00751179|Secondary|Change From Baseline in Plasma Potassium Levels at 15 Minutes After Treatment With Rocuronium or Succinylcholine|"Change from baseline = 15 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium or succinylcholine dose. Only data post rocuronium dose are included for rocuronium - sugammadex group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period)."|Baseline and 15 minutes post dose|Participants who received rocuronium or succinylcholine with evaluable (i.e., not missing or hemolyzed) blood samples for potassium measurement at baseline and at the 15 minute post-dose time point.||mmol/L||Standard Deviation|Mean
774775|NCT00751179|Secondary|Change From Baseline in Plasma Potassium Levels at 10 Minutes After Treatment With Sugammadex|"Change from baseline = 10 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium dose. Only data post sugammadex dose are included for rocuronium - sugammadex group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period)."|Baseline and 10 minutes post dose|Participants who received sugammadex with evaluable (i.e., not missing or hemolyzed) blood samples for potassium measurement at baseline and at the 10 minute post-dose time point.||mmol/L||Standard Deviation|Mean
774776|NCT00751179|Secondary|Change From Baseline in Plasma Potassium Levels at 10 Minutes After Treatment With Rocuronium or Succinylcholine|"Change from baseline = 10 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium or succinylcholine dose. Only data post rocuronium dose are included for rocuronium - sugammadex group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period)."|Baseline and 10 minutes post dose|Participants who received rocuronium or succinylcholine with evaluable (i.e., not missing or hemolyzed) blood samples for potassium measurement at baseline and at the 10 minute post-dose time point.||mmol/L||Standard Deviation|Mean
774777|NCT00751179|Secondary|Change From Baseline in Plasma Potassium Levels at 2 Minutes After Treatment With Sugammadex|"Change from baseline = 2 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium dose. Only data post sugammadex dose are included for rocuronium - sugammadex group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period)."|Baseline and 2 minutes post dose|Participants who received sugammadex with evaluable (i.e., not missing or hemolyzed) blood samples for potassium measurement at baseline and at the 2 minute post-dose time point.||mmol/L||Standard Deviation|Mean
774778|NCT00751179|Secondary|Change From Baseline in Plasma Potassium Levels at 2 Minutes After Treatment With Rocuronium or Succinylcholine|"Change from baseline = 2 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium or succinylcholine dose. Only data post rocuronium dose are included for rocuronium - sugammadex group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period)."|Baseline and 2 minutes post dose|Participants who received rocuronium or succinylcholine with evaluable (i.e., not missing or hemolyzed) blood samples for potassium measurement at baseline and at the 2 minute post-dose time point.||mmol/L||Standard Deviation|Mean
774779|NCT00751179|Primary|Change From Baseline in Plasma Potassium Levels at 5 Minutes After Treatment With Rocuronium or Succinylcholine|"Change from baseline = 5 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium or succinylcholine dose. Only data post rocuronium dose are included for rocuronium - sugammadex group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period)."|Baseline and 5 minutes post dose|Participants who received rocuronium or succinylcholine with evaluable (i.e., not missing or hemolyzed) blood samples for potassium measurement at baseline and at the 5 minute post-dose time point.||mmol/L||Standard Deviation|Mean
774780|NCT00751296|Secondary|Percentage of Participants With Progression-free Survival (PFS) and Overall Survival (OS).|Assess the time to disease progression and overall survival. (Progressive disease is defined as at least one of the following: more than or equal to 50% increase in the sum of the products of the greatest diameters of at least 2 lymph nodes on 2 consecutive determinations 2 weeks apart (at least one node must be ≥ 2 cm) or new palpable lymph nodes, more than or equal to 50% increase in the size of the liver and/or spleen as determined by measurement below the costal margin or appearance of palpable hepatomegaly or splenomegaly not previously present, more than or equal to 50% increase in the absolute number of circulating lymphocytes to at least 5.0 x109/L, OR transformation to a more aggressive histology (e.g. Richter’s syndrome or prolymphocytic leukemia with >55% prolymphocytes)).|Patients will be treated with lenalidomide until disease progression or 2 cycles past CR (no maximum of cycles). Participants were followed upto 53.2 months for the final data analysis.|||percentage of participants||95% Confidence Interval|Number
774781|NCT00751296|Primary|To Assess the Efficacy (Response Rate) of Oral Lenalidomide in the Treatment of Patients With Symptomatic, Previously Untreated, Chronic Lymphocytic Leukemia (CLL)|"The primary endpoint was objective response to lenalidomide (Complete response +Partial response) evaluated as per the revised 1996 National Cancer Institute Working Group Guidelines.
Complete response: absence of lymphadenopathy and organomegaly by physical exam and radiology, absence of constitutional symptoms, normal CBC. Bone marrow to be done 2 months after the above criteria are met, must be normocellular, with <30% lymphocytes.
Partial Response: ≥ 50% decrease in the peripheral blood lymphocytes from pre-treatment value, ≥ 50% reduction in lymphadenopathy and organomegaly by physical exam or on CT scan. one or more of the following: neutrophils ≥ 1.5 x109/L, platelets > 100 x109/L or 50% improvement over baseline, hemoglobin > 110 g/L or 50% improvement over baseline (without transfusion)."|Patients will be treated with lenalidomide until disease progression or 2 cycles past CR (no maximum of cycles). Participants were followed upto 53.2 months for the final data analysis.|Severe toxicities were seen in the first two patients enrolled on the initial protocol. The study was halted and the protocol amended to use a starting dose of lenalidomide 2.5 mg with monthly escalations to a target dose of 10 mg, extended tumor lysis prophylaxis and monitoring. 25 response evaluable patients were enrolled on the amended protocol.||participants|||Number
774782|NCT00751348|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.|During the entire study period (from Day 0 up to Day 43 or Day 57)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.||Participants|||Count of Participants
774783|NCT00751348|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.|Within the 43-day (Days 0-42) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.||Participants|||Count of Participants
774784|NCT00751348|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms assessed were fever [defined as rectal temperature ≥38.0 degrees Celsius (°C)], rash, meningism and parotid gland swelling. Any= incidence of the specified symptoms regardless of intensity grade or relationship to study vaccine. Grade 3 fever= rectal temperature above (>) 39.5°C. Grade 3 rash= more than 150 lesions. Grade 3 meningism and parotid gland swelling= meningism/parotid gland swelling symptom which prevented normal everyday activities. Related = general symptom assessed by the investigator as causally related to the vaccination.|During the 43-day (Days 0-42) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had the symptoms sheet filled in.||Participants|||Count of Participants
774785|NCT00751348|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cry when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had their symptoms sheet filled in.||Participants|||Count of Participants
774786|NCT00751348|Secondary|Antibody Titers Against Varicela Viruses|Antibody titers were presented as geometric mean titers (GMTs).|At 42-days post-vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who were seronegative for at least one vaccine antigen at baseline and for whom pre-vaccination and post-vaccination serology results were available.||Titers||95% Confidence Interval|Geometric Mean
774787|NCT00751348|Secondary|Antibody Concentrations Against Rubella|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).|At 42-days post-vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who were seronegative for at least one vaccine antigen at baseline and for whom pre-vaccination and post-vaccination serology results were available.||IU/mL||95% Confidence Interval|Geometric Mean
775772|NCT00753948|Secondary|Lung Function as Measured by Plethysmography||During study visits, measures are obtained prior to intervention (intravenous or nebulized) and 60, 120 minutes post intervention.||||||
774788|NCT00751348|Secondary|Antibody Concentrations Against Mumps|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in units per milliliter (U/mL).|At 42-days post-vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who were seronegative for at least one vaccine antigen at baseline and for whom pre-vaccination and post-vaccination serology results were available.||U/mL||95% Confidence Interval|Geometric Mean
774789|NCT00751348|Secondary|Antibody Concentrations Against Measles|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).|At 42-days post-vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who were seronegative for at least one vaccine antigen at baseline and for whom pre-vaccination and post-vaccination serology results were available.||mIU/mL||95% Confidence Interval|Geometric Mean
774790|NCT00751348|Primary|Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Zoster Virus (VZV) Antibodies Above the Cut-off Values|Seroconversion was defined as the appearance of antibodies [i.e. titer greater than or equal to (≥) the cut-off value] in the sera of subjects seronegative [i.e. titer below (<) cut-off value] before vaccination. Cut-off values were the following: Anti-measles concentration ≥ 150 milli-international units per milliliter (mIU/mL); Anti-mumps concentration ≥ 231 units per milliliter (U/mL); Anti-rubella concentration ≥ 4 international units per milliliter (IU/mL); Anti-VZV titer ≥ 1:4 dilution.|At 42 days post-vaccination|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity,which included all evaluable subjects who were seronegative for at least one vaccine antigen at baseline and for whom pre-vaccination and post-vaccination serology results were available.||Participants|||Count of Participants
774791|NCT00751400|Secondary|Number of Dosing Occasions Per Subject That Exceeded 660 mg|Dosing occasion means a single occasion in which a subject reported consuming the study drug. Multiple dosing occasions were possible throughout one use-day. For example, if a subject took one tablet at 6 am this would result in one dosing occasion. If the same subject took one tablet later that same day at 8 pm this would result in a second dosing occasion.|1 month|Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days||dosing occasions||Standard Deviation|Mean
774792|NCT00751400|Secondary|Number of Total Dosing Occasions Per Subject|Dosing occasion means a single occasion in which a subject reported consuming the study drug. Multiple dosing occasions were possible throughout one use-day. For example, if a subject took one tablet at 6 am this would result in one dosing occasion. If the same subject took one tablet later that same day at 8 pm this would result in a second dosing occasion.|1 month|Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days||dosing occasions||Standard Deviation|Mean
774793|NCT00751400|Secondary|Number of Subjects That Have Taken Study Drug on More Than 10 Consecutive Days and Not on More Than 10 Consecutive Days|This measure is reporting how many subjects exceeded the label limit for consecutive days of study drug dosing|1 month|number of subjects reporting at least one tablet taken at any point during study||participants|||Number
774794|NCT00751400|Secondary|Average Daily Dose||1 month|Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days||mg||Standard Deviation|Mean
774795|NCT00751400|Secondary|Number of Subjects With and Without More Than 660 mg at Least Once|This measure refers to number of subjects that exceeded 660 mg of naproxen sodium per day at least once during the reporting period. The maximum dose (660 mg) may have been exceeded with one dose (if a subject consumed two tablets in one dosing occasion) or may have been exceeded throughout the course of a use-day (if a subject took one tablet in one dosing occasion and then later in the same day took one or more tablets in another dosing occasion).|1 month|Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days||participants|||Number
774796|NCT00751400|Secondary|Number of Subjects With and Without Next Dose Less Than 22 Hours Later|This Outcome is a measure of subjects while Outcome Measure 3 provides the outcome as a measure of cumulative number of use-days for all subjects involved.|1 month|Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days||participants|||Number
774797|NCT00751400|Secondary|Number of Subjects With and Without More Than One Tablet Taken Per Dose||1 month|Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days||participants|||Number
774798|NCT00751400|Secondary|Use Days With and Without Next Dose Less Than 22 Hours Later|Use-days were calculated based on days in which there was subject-reported product consumption, meaning that if a tablet was consumed on a day this resulted in one use-day. If a subject reported product consumption on three different days this resulted in three use-days. The cumulative expression of use-days is the total number of use-days reported by all subjects with follow up data.|1 month|Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days||days|||Number
774799|NCT00751400|Secondary|Dosing Occasions With One and More Than One Tablet Taken|Dosing occasion means a single occasion in which a subject reported consuming the study drug. Multiple dosing occasions were possible throughout one use-day. For example, if a subject took one tablet at 6 am this would result in one dosing occasion. If the same subject took one tablet later that same day at 8 pm this would result in a second dosing occasion.|1 month|Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days||dosing occasions|||Number
774800|NCT00751400|Primary|Use Days With One or More Misuse Occasions|Misuse occasion: any reported use of 2 or more tablets within a 22 hour period (included use of 2 tablets in 1 dose or the use of 1 tablet at one time and 1+ tablets at a later time within the same 22 hour period). Use-days were calculated based on days in which there was subject-reported product consumption, meaning that if a tablet was consumed on a day this resulted in 1 use-day. If a subject reported product consumption on 3 different days this resulted in 3 use-days. The cumulative expression of use-days is the total number of use-days reported by all subjects with follow up data.|1 month|Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days||days|||Number
774801|NCT00751530|Secondary|Percentage of Participants Using Etravirine in Background Regimen|These results report the percent of participants using Etravirine in the background regimen.|Background regimen (no specific time frame)|||Percentage of Participants|||Number
774803|NCT00751530|Secondary|Baseline Genotypic Sensitivity Score (GSS). The Minimal Value Was 0 and the Maximum Values Was 5.4. (0 = Minimal to no Activity in Regimen and 5.4 = High to Maximal Activity in Regimen)|The baseline GSS is calculated by the sum of resistance scores for each drug in the regimen. For each drug in the regimen a resistance score of 0, 0.5 or 1 was assigned for high, low or no levels of resistance, respectfully. The resistance assignment was based on either the Stanford database interpretation or presence of primary IAS mutation levels of resistance. Inclusion of maraviroc or new use of enfuvirtide in the regimen was scored a 1.0. The sum of the scores of the active drugs, not including raltegravir, constituted the baseline GSS.|Baseline|||score||Full Range|Mean
774804|NCT00751530|Secondary|CD4 Cell Changes Among Participants in PI vs Non-PI Group|CD4 cell counts were measured using standard of care testing via local laboratories.|baseline to 24 Weeks|||cells/mm3||Full Range|Mean
774805|NCT00751530|Secondary|Percentage of Participants With Viral Load < 75 Copies/ mL at Week 12|The HIV RNA (viral load) was measured using standard of care testing via local laboratories.|12 weeks|||Percentage of participants|||Number
774806|NCT00751621|Secondary|Rate, Severity and Relatedness of Any Adverse Events (AEs) Per Infusion|The rate of AEs was the number of AEs over the number of infusions administered. Mild AE: Did not interfere with routine activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities. At least possibly related AEs included possibly related AEs, probably related AEs, and related AEs.|Up to 42 months|The AT safety data set comprised all subjects treated with IgPro20 during any study period.||AEs per infusion|Participants||Number
774807|NCT00751621|Secondary|Clinically Significant Abnormal Changes in Routine Laboratory Parameters Between Baseline and the Completion Visit.|The total number of subjects with clinically significant abnormal changes in routine laboratory parameters between baseline and the completion visit. Routine laboratory parameters included haematology, serum chemistry and urinalysis.|At baseline (data either from Infusion 40 or the completion visit of study ZLB06_001CR), and at completion (up to 42 months).|The AT safety data set (which comprised all subjects treated with IgPro20 during any study period and was identical to the ITT data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available) and for whom laboratory parameter data was collected at both baseline and completion.||participants|||Number
774808|NCT00751621|Secondary|Clinically Relevant Changes in Vital Signs From Baseline to the Completion Visit.|The total number of subjects with clinically relevant changes in vital signs from baseline to the completion visit. Vital signs included heart rate, systolic blood pressure, diastolic blood pressure, and body temperature.|At baseline (data either from Infusion 40 or the completion visit of study ZLB06_001CR), and at completion (up to 42 months).|The AT safety data set (which comprised all subjects treated with IgPro20 during any study period and was identical to the ITT data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available) and for whom vital signs data was collected at both baseline and completion.||participants|||Number
774809|NCT00751621|Secondary|Health Related Quality of Life (Short Form 36 Health Survey)|The Short Form 36 Health Survey (SF-36) is a 36-item questionnaire that measures generic health concepts that are relevant across age, disease, and treatment groups. The questions are grouped into eight domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores range from 0 to 100, with higher scores indicating a better health state.|At baseline and at the last available post-baseline observation for each subject (up to 42 months)|The analysis population comprised the Full-Analysis health related quality of life (HRQL) data set (defined as all subjects entered into the study who complete a baseline and at least 1 follow-up HRQL assessment), who were at least 15 years of age.||score on a scale||Full Range|Median
774810|NCT00751621|Secondary|Use of Antibiotics for Infection Prophylaxis and Treatment|Annualized rate of days with antibiotics for infection prophylaxis and treatment. The annualized rate was based on the total number of days of antibiotic use for infection prophylaxis and treatment in the efficacy period, and the total number of subject study days for all subjects in the specified analysis population, and adjusted to 365 days.|Up to 42 months|The AT safety data set comprised all subjects treated with IgPro20 during any study period and was identical to the ITT data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available.||days per subject year|Participants||Number
774811|NCT00751621|Secondary|Number of Days of Hospitalization Due to Infections|Total number of days of hospitalization due to infections for the specified analysis population|Up to 42 months|The AT safety data set comprised all subjects treated with IgPro20 during any study period and was identical to the ITT data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available.||days|||Number
774812|NCT00751621|Secondary|Annualized Rate of Hospitalization Due to Infections|The annualized rate was based on the total number of days of hospitalization due to infections and the total number of subject diary days for all subjects in the specified analysis population and adjusted to 365 days.|Up to 42 months|The AT safety data set comprised all subjects treated with IgPro20 during any study period and was identical to the ITT data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available.||days per subject year|Participants||Number
774813|NCT00751621|Secondary|Number of Days Out of Work / School / Kindergarten / Day Care or Unable to Perform Normal Activities Due to Infections|Total number of days out of work / school / kindergarten / day care or unable to perform normal activities due to infections, for the specified analysis population|Up to 42 months|The AT safety data set comprised all subjects treated with IgPro20 during any study period and was identical to the ITT data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available.||days|||Number
774814|NCT00751621|Secondary|Annualized Rate of Days Out of Work / School / Kindergarten / Day Care or Unable to Perform Normal Activities Due to Infections|The annualized rate was based on the total number of days out of work / school / kindergarten / day care or inability to perform normal activities due to infection, and the total number of subject diary days for all subjects in the specified analysis population and adjusted to 365 days.|Up to 42 months|The AT safety data set comprised all subjects treated with IgPro20 during any study period and was identical to the ITT data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available.||days per subject year|Participants||Number
787356|NCT00849940|Secondary|Correlation Between NIRS Derived Estimate of Hemoglobin Concentration and Measured Arterial Blood Hemoglobin Concentration.||Data collected from individual participants over 4 hour timeframe|Data not collected.|||||
774816|NCT00751621|Secondary|Annualized Rate of Infection Episodes|The annualized rate was based on the total number of infection episodes occurring during the study divided by the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.|Up to 42 months|The AT safety data set comprised all subjects treated with IgPro20 during any study period and was identical to the ITT data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available.||infection episodes per subject year|Participants|95% Confidence Interval|Number
774817|NCT00751621|Secondary|Annualized Rate of Clinically Documented Serious Bacterial Infections (SBIs)|"The annualized rate was based on the total number of SBIs and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.
Potential SBIs included bacterial pneumonia, bacteremia and septicemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess. If an adverse event (AE) was identified as a potential SBI, the AE was adjudicated by the Medical Monitor and Investigator to determine if the event fulfilled the predefined criteria for SBIs."|Up to 42 months|The AT safety data set comprised all subjects treated with IgPro20 during any study period and was identical to the ITT data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available.||SBIs per subject year|Participants||Number
774818|NCT00751621|Primary|Total Serum IgG Trough Levels|The IgG trough values per subject were aggregated to a median value, and then median values across subjects were summarized using descriptive statistics.|Up to 42 months|The “all treated” (AT) safety data set comprised all subjects treated with IgPro20 during any study period and was identical to the “Full Analysis/intention-to-treat” (ITT) data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available.||g/L||Standard Deviation|Mean
774819|NCT00751634|Secondary|Number of Participants With Arrhythmia|New ventricular tachycardia, ventricular fibrillation, atrial fibrillation or other unstable cardiac rhythm|Six hours|||participants|||Number
774820|NCT00751634|Secondary|Number of Participants With Hypotension|New systolic blood pressure < 100 mm Hg, or new vasopressor use during study period|six hours|||participants|||Number
774821|NCT00751634|Secondary|Number of Participants With Severe Shivering|"Severe shivering as measured by the bedside shivering assessment scale: 0 None: no shivering noted on palpation of the masseter, neck, or chest wall
Mild: shivering localized to the neck and/or thorax only
Moderate: shivering involves gross movement of the upper extremities (in addition to neck and thorax)
Severe: shivering involves gross movements of the trunk and upper and lower extremities"|six hours|All participants were analyzed for the outcome of BSAS=3||participants|||Number
774822|NCT00751634|Secondary|Time From Start of Cooling Device to Core Temperature < 100.4F|For all patients, the time until the core temperature (measured with a urinary catheter in place for usual clinical care) was <100.4F|Six hours|||hours||Standard Deviation|Mean
774823|NCT00751634|Primary|Core Temperature as Measured With an Approved Device (Urinary Catheter) in Place for Usual Clinical Care|Core temperature (in degrees Fahrenheit, F) throughout the study period. The cooling blanket was in place throughout the study period unless severe shivering led to termination per protocol.|baseline, one, two and six hours after application.|||degrees F||Standard Deviation|Mean
774824|NCT00751777|Primary|Seroconversion (SCR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo|"Definition of SCR:
Seroconversion IgG: ≥ 2-fold rise of LT IgG titer relative to baseline
Seroconversion IgA: ≥ 4-fold rise of LT IgA titer relative to baseline"|Day 14, Day 21, Day 28, Day 35, Day 90, Day 194|Immunogenicity Evaluable Population (IEP): all study subjects who are consented, randomized, received the assigned treatments (both vaccinations), and had blood drawn for immunogenicity testing at baseline (Day 0) and both of the following time points: Day 21 and Day 35.||percentage of participants||95% Confidence Interval|Number
774825|NCT00751777|Primary|Geometric Mean Fold Ratio (GMFR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo|GMFRs relative to the baseline titer were determined at each post-baseline time point. All GMFRs were based on log10-transformed data.|Day 14, Day 21, Day 28, Day 35, Day 90, Day 194|Immunogenicity Evaluable Population (IEP): all study subjects who are consented, randomized, received the assigned treatments (both vaccinations), and had blood drawn for immunogenicity testing at baseline (Day 0) and both of the following time points: Day 21 and Day 35.||ratio||95% Confidence Interval|Number
774826|NCT00751777|Secondary|Evaluation of Duration of LT-specific Immune Responses One-year After Original Treatment Regimen in LT Patch Group||13 months||||||
774827|NCT00751777|Secondary|Evaluation of Residual LT in the Patch and on the Skin at the Patch Site Post-wear||1 month||||||
774828|NCT00751777|Secondary|Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch||7 months||||||
774829|NCT00751777|Primary|Geometric Mean Titer (GMT) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo||Day 0, Day 14, Day 21, Day 28, Day 35, Day 90, Day 194|Immunogenicity Evaluable Population (IEP): all study subjects who are consented, randomized, received the assigned treatments (both vaccinations), and had blood drawn for immunogenicity testing at baseline (Day 0) and both of the following time points: Day 21 and Day 35.||geometric mean titer||95% Confidence Interval|Geometric Mean
774830|NCT00751790|Secondary|LH Increase|% of patients showing ≤1.0 IU/L increase in s-LH from 0 to 2 h after 1st & 2nd injection.% changes in PSA throughout treatment.% of 60 pts with s-testosterone levels >1.735 nmol/L after 2nd injection.Testosterone PD and triptorelin PK metrics in 15 pts|day 1 and day 169||||||
774831|NCT00751790|Primary|Achievement of Castration and Maintenance of Castration|Percentage of patients achieving castrate testosterone levels (≤1.735 nmol/L) by Day 29 (28 days after study drug injection) and percentage of patients maintaining castrate testosterone levels from Month 2 to end of Month 12 (Week 48).|at Day 29|||percentage of enrolled patients|||Number
774878|NCT00752609|Secondary|Percentage of Participants With Red Blood Cell Transfusions|The percentage of participants who received one or more red blood cell transfusions, including packed red blood cells and whole blood transfusions, during the Titration Period (Weeks 0 - 18) and Evaluation Period (Weeks 19 -24). 95% Confidence Intervals were calculated from the normal approximation with continuity correction.|Up to 24 weeks.|Full Analysis Set.||percentage of participants||95% Confidence Interval|Number
775857|NCT00754065|Secondary|Number of Spotting-only Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure||Episodes||Standard Deviation|Mean
774832|NCT00751881|Other Pre-specified|Core Treatment Period: Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA)|"PCSA values are abnormal values considered medically important by the Sponsor according to predefined criteria based on literature review.
Hepatic parameters thresholds were defined as follows:
Alanine Aminotransferase (ALT) >3, 5, 10 or 20 upper limit of normal(ULN);
Aspartate aminotransferase (AST) >3, 5, 10 or 20 ULN;
Alkaline Phosphatase >1.5 ULN;
Total Bilirubin (TB) >1.5 or 2 ULN;
ALT >3 ULN and TB >2 ULN."|From first study drug intake up to 112 days after last intake in the core treatment period or up to first intake in the extension treatment period, whichever occurred first|"All randomized and treated participants. Participants were considered according to the drug actually received.
The 3 participants in the placebo group who received teriflunomide were analyzed according to the teriflunomide dose.
The participant in the teriflunomide 14 mg group who received 7 mg was analyzed in the teriflunomide 7 mg group."||participants|||Number
774833|NCT00751881|Secondary|Extension Treatment Period: ARR: Poisson Regression Estimate|"ARR was obtained from the total number of confirmed relapses that occurred during the treatment period divided by the sum of treatment durations. A relapse is defined as the appearance of a new clinical sign/symptom or clinical worsening of a previous sign/symptom (one that had been stable for at least 30 days) that persists for a minimum of 24 hours in the absence of fever. Relapse was confirmed by an increase in EDSS score or Functional System scores. To account for the different treatment durations among participants, a Poisson regression model with robust error variance was used (total number of confirmed relapses as response variable; log-transformed treatment duration as offset variable; treatment group, region of enrolment and baseline EDSS stratum as covariates)."|Extension treatment period (Maximum: 174 weeks)|ITT population for extension treatment period consists of all participants with a signed informed consent form for the extension and with a date of treatment allocated or recorded in the IVRS/IWRS database, regardless of whether the treatment was actually taken.||relapses per year||95% Confidence Interval|Number
774834|NCT00751881|Secondary|Extension Treatment Period: Time to Disability Progression|"Probability of disability progression since the randomization of the core period was estimated using Kaplan-Meier method on the time to disability progression defined as the time from randomization to first 12 week sustained disability progression [i.e. increase from baseline of at least 1 point in EDSS score (at least 0.5 point for participants with baseline EDSS score >5.5) that persisted for at least 12 weeks].
Participants free of disability progression (no disability progression observed on treatment) were censored at the date of the last on-treatment EDSS evaluation.
Kaplan-Meier method consists in computing probabilities of non occurrence of event at any observed time of event and multiplying successive probabilities for time ≤t by any earlier computed probabilities to estimate the probability of being event free for the amount of time t. Probability of event at time t was 1 minus the probability of being event-free for the amount of time t."|Core treatment period (maximum: 173 weeks) and Extension treatment period (maximum: 174 weeks)|ITT population for extension treatment period consists of all participants with a signed informed consent form for the extension and with a date of treatment allocated or recorded in the IVRS/IWRS database, regardless of whether the treatment was actually taken.||percent probability||95% Confidence Interval|Number
774835|NCT00751881|Secondary|Extension Treatment Period: Overview of Treatment Emergent Adverse Events (TEAE)|AEs were any unfavourable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.|From first intake of study drug in extension treatment period up to 28 days after the last intake in the extension treatment period|"Safety population: all randomized participants who received at least 1 dose of investigational product.
Two participants in placebo of core study received teriflunomide and were analyzed according to teriflunomide dose.
One participant in teriflunomide 14 mg in core study group who received 7 mg was analyzed in teriflunomide 7 mg group."||participants|||Number
774836|NCT00751881|Secondary|Core Treatment Period: Overview of Adverse Events|Adverse Events (AE) are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.|From first study drug intake up to 112 days after last intake in the core treatment period or up to first intake in the extension treatment period, whichever occurred first|"All randomized and treated participants. Participants were considered according to the drug actually received.
The 3 participants in the placebo group who received teriflunomide were analyzed according to the teriflunomide dose.
The participant in the teriflunomide 14 mg group who received 7 mg was analyzed in the teriflunomide 7 mg group."||participants|||Number
774837|NCT00751881|Secondary|Core Treatment Period: Change From Baseline to Last Visit in Short Form Generic Health Survey - 36 Items (SF-36) Summary Scores|Baseline adjusted least-squares means at last visit were estimated using an analysis of covariance (ANCOVA) model on collected data for each summary score (treatment group, region of enrollment, baseline EDSS stratum, visit number for the last visit and baseline value as factors).|Baseline (before randomization) and up to Week 152|Intent-to-treat population||units on a scale||Standard Error|Least Squares Mean
774838|NCT00751881|Secondary|Core Treatment Period: Change From Baseline to Week 48 in Short Form Generic Health Survey - 36 Items (SF-36) Summary Scores|"SF-36 scale is a generic, self-administered, health-related quality-of-life (QOL) instrument. It is constructed such that the 36 questions represent 8 of the most important health concepts: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health.
Two summary scores are obtained:
the physical health component summary score,
the mental health component summary score.
Both scores range from 0 to 100 and a high score indicates a more favorable health state.
Baseline adjusted least-squares means at week 48 were estimated using a Mixed-effect model with repeated measures [MMRM] on each summary score data (treatment group, region of enrollment, baseline EDSS stratum, visit, treatment-by-visit interaction, baseline value, and baseline-by-visit interaction as factors). All the timepoints from randomization up to Week 48 were included in the model."|Baseline (before randomization), Week 12, Week 24 and Week 48|Intent-to-treat population||units on a scale||Standard Error|Least Squares Mean
774839|NCT00751881|Secondary|Core Treatment Period: Change From Baseline to Last Visit in Fatigue Impact Scale (FIS) Total Score|Baseline adjusted least-squares means at last visit were estimated using an analysis of covariance (ANCOVA) model on collected data for FIS total score (treatment group, region of enrollment, baseline EDSS stratum, visit number for the last visit and baseline value as factors).|Baseline (before randomization) and up to Week 152|Intent-to-treat population||units on a scale||Standard Error|Least Squares Mean
774840|NCT00751881|Secondary|Core Treatment Period: Change From Baseline to Week 48 in Fatigue Impact Scale (FIS) Total Score|"FIS is a participants-reported scale that qualifies the impact of fatigue on daily life in participants with MS. It consists of 40 statements that measure fatigue in 3 areas; physical, cognitive, and social.
FIS total score ranges from 0 (no problem) to 160 (extreme problem).
Baseline adjusted least-squares means at week 48 were estimated using a Mixed-effect model with repeated measures (MMRM) on FIS total score data (treatment group, region of enrollment, baseline EDSS stratum, visit, treatment-by-visit interaction, baseline value, and baseline-by-visit interaction as factors). All the timepoints from randomization up to Week 48 were included in the model."|Baseline (before randomization), Week 12, Week 24 and Week 48|Intent-to-treat population||units on a scale||Standard Error|Least Squares Mean
774841|NCT00751881|Secondary|Core Treatment Period: Change From Baseline to Week 48 in EDSS Total Score|"EDSS is an ordinal scale in half-point increments that qualifies disability in participants with MS. It consists of 8 ordinal rating scales assessing 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation.
EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS).
Baseline adjusted least-squares means at Week 48 were estimated using a Mixed-effect model with repeated measures (MMRM) on EDSS score data (treatment group, region of enrollment, baseline EDSS stratum, visit, treatment-by-visit interaction, baseline value, and baseline-by-visit interaction as factors). All the timepoints from randomization up to Week 48 were included in the model."|Baseline (before randomization), Week 12, Week 24, Week 36 and Week 48|Intent-to-treat population||units on a scale||Standard Error|Least Squares Mean
774842|NCT00751881|Secondary|Core Treatment Period: Time Without Relapse|"Probability of no relapse at 24, 48, 108 and 132 weeks was estimated using Kaplan-Meier method on the time to relapse defined as the time from randomization to first EDSS confirmed relapse.
Participants free of confirmed relapse (no EDSS confirmed relapse observed on treatment) were censored at the date of the last study drug intake."|Core treatment period between 48 - 152 weeks depending on time of enrollment|Intent-to-treat population||percent probability||95% Confidence Interval|Number
774843|NCT00751881|Secondary|Core Treatment Period: Time to Disability Progression|"Probability of disability progression at 24, 48, 108 and 132 weeks was estimated using Kaplan-Meier method on the time to disability progression defined as the time from randomization to first 12-week sustained disability progression [i.e. increase from baseline of at least 1 point in EDSS score (at least 0.5 point for participants with baseline EDSS score >5.5) that persisted for at least 12 weeks].
Participants free of disability progression (no disability progression observed on treatment) were censored at the date of the last on-treatment EDSS evaluation.
Kaplan-Meier method consists in computing probabilities of non occurrence of event at any observed time of event and multiplying successive probabilities for time ≤t by any earlier computed probabilities to estimate the probability of being event-free for the amount of time t. Probability of event at time t is 1 minus the probability of being event-free for the amount of time t."|Core treatment period between 48 - 152 weeks depending on time of enrollment|Intent-to-treat population||percent probability||95% Confidence Interval|Number
774844|NCT00751881|Primary|Core Treatment Period: Annualized Relapse Rate (ARR): Poisson Regression Estimate|"ARR is obtained from the total number of confirmed relapses that occurred during the treatment period divided by the sum of treatment durations.
Each episode of relapse - appearance, or worsening of a clinical symptom that was stable for at least 30 days, that persisted for a minimum of 24 hours in the absence of fever - was to be confirmed by an increase in Expanded Disability Status Scale (EDSS) score or Functional System scores.
To account for the different treatment durations among participants, a Poisson regression model with robust error variance was used (total number of confirmed relapses as response variable; log-transformed treatment duration as offset variable; treatment group, region of enrollment and baseline EDSS stratum as covariates)."|Core treatment period between 48 - 152 weeks depending on time of enrollment|Intent-to-treat population: all randomized and treated participants. Participants were considered in the treatment group to which they were randomized regardless of the drug they actually received.||relapses per year||95% Confidence Interval|Number
774845|NCT00751933|Secondary|Symptom Score Improvement of 2 or More During or After 6 Months|No patient completed the study, therefore we have no information to report.|6 months||||||
774846|NCT00751933|Primary|Symptom Score Improvement of 3 or More During or After 6 Months|No patient completed the study, therefore we have no information to report.|6 months||||||
774847|NCT00751972|Secondary|Quality of Life Change From Baseline to 180 Days, as Measured by EuroQoL EQ-5D|"The EQ-5D is a standardized instrument for use as a generic measure of the quality of health-related life and of health outcome.
The EuroQoL EQ-5D is a descriptive system of health-related quality of life states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses. The responses record five levels of severity (no problems/slight problems/moderate problems/severe problems/extreme problems) within a particular EQ-5D dimension.
Scores are transformed to a range of 0-100, in which higher scores reflect better health status."|Baseline and 180 Days|Number of participants with both baseline and 180 day data were used for this analysis of QOL||units on a EuroQol EQ-5D scale||Standard Deviation|Mean
774848|NCT00751972|Secondary|Change in Distance Walked in the 6-minute Walk Test Between Baseline and 180 Days|"The 6MWT is a simple test which does not require expensive equipment or advanced training for technicians. The test involves asking the patient to walk the longest distance possible in a set interval of 6 min, through a walking course (corridor) preferably 30-m long. The patient can stop or slow down at any time and then resume walking, depending on his/her degree of fatigue.
A longer distance walked is indicative of a better outcome."|Baseline and 180 Days|Number of participants with both baseline and 180 day data were used for this analysis of 6 minute walk distance.||meters||Standard Deviation|Mean
774879|NCT00752609|Secondary|Percentage of Participants With a Change in Hemoglobin From Baseline to the Evaluation Period Within 1 g/dL|"Percentage of participants with a mean change in hemoglobin between Baseline (the mean of the 4 most recent hemoglobin values prior to enrollment and the hemoglobin on the day of enrollment) and the Evaluation Period (mean hemoglobin measured at Weeks 19 to 24) of less than or equal ± 1 g/dL.
The 95% confidence interval was calculated from the normal approximation with continuity correction."|Baseline and Week 19 to Week 24.|Full analysis set where data was available.||percentage of participants||95% Confidence Interval|Number
787357|NCT00849940|Secondary|Correlation Between Somatic StO2 and Cerebral SctO2 Oxygen Saturation||Data collected from individual participants over 4 hour timeframe|Data not collected|||||
774849|NCT00751972|Secondary|Quality of Life Change From Baseline to 180 Days, as Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)|"KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life for patients with congestive heart failure. It is a predictive tool that tracks how patients are doing if they have weakened heart muscle due to prior heart attacks, heart valve problems, viral infections, or other causes.
The KCCQ’s questions are used to calculate scores in ten domains:
Physical Limitation, Symptom Stability, Frequency, Burden and Total Symptom. Social Limitation, Self-Efficacy, Quality of Life, and Clinical Summary. Overall Summary: a combined measure of all the above
For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Scores are transformed to a range of 0-100, in which higher scores reflect better health status."|Baseline and 180 Days|Number of participants with both baseline and 180 day data were used for this analysis of QOL.||units on a KCCQ scale||Standard Deviation|Mean
774850|NCT00751972|Secondary|Incidence of All Device Failures and Device Malfunctions|The INTERMACS event device malfunction defined a failure of the HeartWare VAS as either pump failure or non-pump failure.|180 Days|The secondary effectiveness analyses were performed on the safety population, consisting of all enrolled subjects who received a Ventricular Assist Device (VAD).||Number of events|||Number
774851|NCT00751972|Secondary|Incidence of Adverse Events, Neurocognitive Status and Unanticipated Adverse Device Effects|Adverse events are only provided for patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS). Adverse events as described by INTERMACS for the contemporaneous control population were not a part of the agreement for analysis and thus not provided by INTERMACS, and so not included in the Adverse Event Module and relevant Outcome Measures for comparison.|180 Days|The secondary effectiveness analyses were performed on the safety population, consisting of all enrolled subjects who received a Ventricular Assist Device (VAD).||percentage of patients|||Number
774852|NCT00751972|Secondary|Survival to 180 Days|All subjects will be followed for date of death until 180 days.|180 Days|The secondary effectiveness analyses were performed on the safety population, consisting of all enrolled subjects who received a Ventricular Assist Device (VAD).||Percentage of participants with survival|||Number
774853|NCT00751972|Primary|The Primary Endpoint is Success at 180 Days Which is Defined as Alive on the Originally Implanted HeartWare® LVAD or Transplanted or Explanted for Recovery. Patient Must Survive 60 Days Post-explant for Recovery to be Considered Successful.|The primary endpoint is success at 180 days which is defined as alive on the originally implanted HeartWare® LVAD or transplanted or explanted for recovery. A patient must survive 60 days post-explant for recovery to be considered successful.|180 days|The primary effectiveness analyses was performed on the safety population, consisting of all enrolled subjects who received a Ventricular Assist Device (VAD).||Percentage of participants with success|||Number
774854|NCT00751998|Secondary|Health Resources Utilization (Health Economics)||Procedure through end of study.||||||
774855|NCT00751998|Secondary|Device Durability and Device Performance.||Procedure||||||
774856|NCT00751998|Secondary|Safety||Procedural through end of study||||||
774857|NCT00751998|Secondary|Sensitivity of SpyBite Biopsy Forceps in Malignant Strictures.||Post Procedure||||||
774858|NCT00751998|Secondary|Ability to Visualize and Access Various Targeted Anatomic Areas.||Procedure||||||
774859|NCT00751998|Secondary|Impact of SpyGlass DVS Cholangioscopy With or Without Biopsy on Subject Management.||Procedure or at 12 months||||||
774860|NCT00751998|Secondary|Impact of SpyGlass DVS Cholangioscopy With or Without Biopsy on Diagnosis.||Procedural through end of study||||||
774861|NCT00751998|Primary|Procedural Success as Defined by: 1. Ability to Visualize Stricture & Obtain Biopsy of Lesion Adequate for Histological Examination in Suspected Malignancy Cases or 2. Ability to Visualize Stone(s) & Successfully Initiate Stone Fragmentation & Removal.||During Procedure|||percent||95% Confidence Interval|Number
774864|NCT00752128|Secondary|Overall Stent Thrombosis, Defined as Definite and Probable Stent Thrombosis, According to the Academic Research Consortium (ARC) Definition||12 Months|Intention to treat||percentage of participants|||Number
774865|NCT00752128|Primary|Composite Endpoint of Cardiac Death and Myocardial Infarction (Not Clearly Attributable to a Non-target Vessel)||12 Months|Analysis per intention to treat||percentage of participants|||Number
774866|NCT00752232|Other Pre-specified|The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 36, 40, 52, 78 and 104.|The MMSE is a brief, structured examination of cognitive function. It has a total score of 30 points (0-30), and any score equal to or lower than 26 points indicates cognitive impairment.|Baseline up to 24 months|Efficacy analyses were performed on the modified intent-to-treat (mITT) population. The mITT population included all of the randomly assigned participants who took at least one dose of study medication, and had the baseline and at least one post baseline evaluation of the key efficacy variable (ADAS-Cog).||Units on a scale||Standard Deviation|Mean
774867|NCT00752232|Other Pre-specified|The Mean Changes in Neuropsychological Test Battery (NTB) Score From Baseline at Week 12, 26, 36, 52, 78 and 104.|The NTB is a composite of nine widely used neuropsychological tests that assess immediate and delayed recall of verbal and visual information, attention, verbal fluency and executive function. The cognitive tests included in the NTB are the Wechsler Memory Scale (WMS) Visual-Paired Associates (immediate and delayed), WMSVerbal Paired Associates (immediate and delayed), Rey Auditory Verbal Learning Test (immediate and delayed), WMS-Digit Span, Controlled Word Association Test, and Category Fluency Test. The NTB z-score is used for analysis. The z-score for each component is calculated through the following formula: z = (y_visit – y_base)/SD_base, where y_visit is a value at a particular time point and y_base is the average test score, and SD_base is the SD based on all participants’ observed baseline scores in the study.|Baseline up to 24 months|Efficacy analyses were performed on the modified intent-to-treat (mITT) population. The mITT population included all of the randomly assigned participants who took at least one dose of study medication, and had the baseline and at least one post baseline evaluation of the key efficacy variable (ADAS-Cog).||Z-score||Standard Deviation|Mean
774868|NCT00752232|Other Pre-specified|The Mean Changes in Disability Assessment for Dementia (DAD) Score From Baseline at Week 12, 26, 36, 52, 78 and 104.|The DAD is administered through an interview with the caregiver and measures instrumental and basic activities of daily living. A total score is obtained by adding the rating for each question and converting this total score out of 100. Higher scores represent less disability in ADL while lower scores indicate more dysfunction.|Baseline up to 24 months|Efficacy analyses were performed on the modified intent-to-treat (mITT) population. The mITT population included all of the randomly assigned participants who took at least one dose of study medication, and had the baseline and at least one post baseline evaluation of the key efficacy variable (ADAS-Cog).||Units on a scale||Standard Deviation|Mean
774869|NCT00752232|Other Pre-specified|The Mean Changes in Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-Cog) Score From Baseline at Week 12, 26, 36, 52, 78 and 104.|The ADAS-Cog is a 12-item,objective measure of cognitive function, consisting of 1) Word Recall, 2) Naming Objects and Fingers, 3) Following Commands, 4) Constructional Praxis, 5) Ideational Praxis, 6) Orientation, 7) Word Recognition, 8) Recall of Test Instructions, 9) Spoken Language Ability, 10) Word-Finding Difficulty, 11) Comprehension of Spoken Language and 12) Concentration/Distractibility. For this stuy, the ADAS-Cog total score is derived by summing the individual scores from items 1 to 11. Total score ranges from 0 to 70 points, with higher scores indicating a greater degree of impairment.|Baseline up to 24 months|Efficacy analyses were performed on the modified intent-to-treat (mITT) population. The mITT population included all of the randomly assigned participants who took at least one dose of study medication, and had the baseline and at least one post baseline evaluation of the key efficacy variable (ADAS-Cog).||Units on a scale||Standard Deviation|Mean
774870|NCT00752232|Secondary|Anti-a-beta IgM Titer at Specified Visits|Geometric mean of anti-a-beta IgM titer from pre-study through Week 104|Baseline up to 24 months|The population for immunogenicity analysis includes all of the randomly assigned participants who took at least one dose of study medication, having the baseline and at least one post baseline immunogenicity evaluation.||Units/mL||95% Confidence Interval|Geometric Mean
774871|NCT00752232|Secondary|Anti-a-beta IgG Titer at Specified Visits|Geometric mean of anti-a-beta IgG titer from pre-study through Week 104|Baseline up to 24 months|The population for immunogenicity analysis includes all of the randomly assigned participants who took at least one dose of study medication, having the baseline and at least one post baseline immunogenicity evaluation.||Units/mL||95% Confidence Interval|Geometric Mean
774872|NCT00752232|Primary|Number of Participants With Abnormalities in Neurological Examination|Number of participants with abnormalities in neurological examinations as determined by the investigators. Neurological examinations included Mental Status, Speech, Cranial Nerves (including pupil equality and reactivity), Visual field, Sensory, Motor, Coordination, Gait, Primitive reflexes, Tendon reflexes and Romberg.|Baseline up to 24 months|The safety analysis population includes all of the randomly assigned participants who took at least one dose of study medication.||Participants|||Number
774873|NCT00752232|Primary|Number of Participants With Brain Abnormalities in Magnetic Resonance Imaging (MRI) Data|Number of participants with brain abnormalities in MRI data that are either consistent or not consistent with AD, as determined by investigator.|Baseline up to 24 months|The safety analysis population includes all of the randomly assigned participants who took at least one dose of study medication.||Participants|||Number
774874|NCT00752232|Primary|Incidence of Treatment-emergent Adverse Events (AEs) by Severity|Number of participants who experienced mild, moderate, or severe AEs (mild = does not interfere with subject's usual function; moderate = interferes to some extent with subject's usual function; severe = interferes significantly with subject's usual function)|Baseline up to 24 months|The safety analysis population includes all of the randomly assigned participants who took at least one dose of study medication.||Participants|||Number
774875|NCT00752609|Secondary|Percentage of Participants With Dose Adjustments During the Study|The peginesatide dose was adjusted to maintain Hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline during the Titration Period (Weeks 0-18) and Evaluation Period (Weeks 19-24). A dose was classified as adjusted if it was not within 20% of the previous dose. A dose was classified as increased or decreased if it was >20% higher or >20% lower respectively, than the previous dose.|From Week 4 to Week 20|Safety Analysis set, which included all patients who received at least 1 dose of study drug. N indicates the number of patients with study drug administered during the period after excluding the initial dose of study drug and excluding the first dose after a restart of study drug and is the denominator for percentage calculations.||percentage of participants|||Number
774876|NCT00752609|Secondary|Percentage of Participants With Target Hemoglobin of 10.0 to 12.0 g/dL by 4-week Intervals.|Percentage of participants with mean hemoglobin levels falling between the target level of 10.0 to 12.0 g/dL during 4-week study intervals. Hemoglobin was measured every 2 weeks during the Titration Period (Weeks 0-18) and weekly during the Evaluation Period (Weeks 19-24). 95% Confidence Intervals were calculated from the normal approximation with continuity correction.|Up to 24 weeks.|Full analysis set where data was available for each time interval (indicated by N).||percentage of participants||95% Confidence Interval|Number
774877|NCT00752609|Secondary|Mean Hemoglobin During 4-week Intervals|Hemoglobin was measured every 2 weeks during the Titration Period (Weeks 0-18) and weekly during the Evaluation Period (Weeks 19-24).|Up to 24 weeks.|Full Analysis Set where data was available for each time interval (indicated by N).||g/dL||Standard Deviation|Mean
774880|NCT00752609|Secondary|Percentage of Participants With Hemoglobin Within the Target Range of 10.0 to 12.0 g/dL During the Evaluation Period|"Mean hemoglobin was calculated from measurements taken during the Evaluation Period from Week 19 to Week 24. The target hemoglobin range was between 10.0 to 12.0 g/dL.
The 95% confidence interval was calculated from the normal approximation with continuity correction."|Week 19 to Week 24|Full Analysis Set where data was available.||percentage of participants||95% Confidence Interval|Number
774881|NCT00752609|Primary|Mean Change in Hemoglobin Between Baseline and the Evaluation Period|Mean change in Hemoglobin between Baseline (the mean of the 4 most recent hemoglobin values prior to enrollment and the hemoglobin on the day of enrollment) and the Evaluation Period (mean hemoglobin from Weeks 19 to 24).|Baseline and Week 19 to Week 24.|The Full Analysis Set including all patients who received at least 1 dose of study drug where data was available (indicated by N).||g/dL||Standard Deviation|Mean
774882|NCT00752622|Secondary|Number of Participants Who Had Clinical Remission Off Steroids in the Interventional Phase|"Number of participants who were in clinical remission and off systemic corticosteroids at visit.
The CDAI incorporates 8 items that are indicators of disease severity. Scores range from 0 to ~600; higher scores indicate worse disease activity. Participants with scores below 150 have inactive disease whereas those with scores above 450 are considered critically ill. Clinical remission was defined as CDAI < 150 at weeks 14-16, 24 and 48 in the Interventional Phase."|Weeks 14-16, 24 and 48 in the Interventional Phase|Due to the early termination of the study, no participants completed the Interventional phase.|||||
774883|NCT00752622|Secondary|Number of Participants Who Had Clinical Remission in the Interventional Phase|"The CDAI incorporates 8 items that are indicators of disease severity. Scores range from 0 to ~600; higher scores indicate worse disease activity. Participants with scores below 150 have inactive disease whereas those with scores above 450 are considered critically ill.
Clinical remission was defined as CDAI < 150 at weeks 14-16, 24 and 48 in the Interventional Phase."|Weeks 14-16, 24 and 48 in the Interventional Phase|Due to the early termination of the study, no participants completed the Interventional phase.|||||
774884|NCT00752622|Secondary|Number of Participants Who Had a Clinical Response Using the CDAI-100 at Weeks 14-16, 24 and 48 in the Interventional Phase|"The CDAI incorporates 8 items that are indicators of disease severity. Scores range from 0 to ~600; higher scores indicate worse disease activity. Participants with scores below 150 have inactive disease whereas those with scores above 450 are considered critically ill.
Clinical response was defined as a 100-point reduction in CDAI score from randomization into the interventional phase or CDAI < 150 at weeks 14-16, 24 and 48 in the Interventional Phase. Baseline is value at randomization."|Baseline and Weeks 14-16, 24 and 48 in the Interventional Phase|Due to the early termination of the study, no participants completed the Interventional phase.|||||
774885|NCT00752622|Secondary|Number of Participants Who Had a Clinical Response Using the CDAI at Weeks 14-16 and 48 in the Interventional Phase|"The CDAI incorporates 8 items that are indicators of disease severity. Scores range from 0 to ~600; higher scores indicate worse disease activity. Participants with scores below 150 have inactive disease whereas those with scores above 450 are considered critically ill.
Clinical response was defined as a 70-point reduction in CDAI score from randomization into the interventional phase or CDAI < 150 at week 14-16 and 48 in the Interventional Phase. Baseline is value at randomization."|Baseline and Weeks 14-16 and 48 in the Interventional Phase|Due to the early termination of the study, no participants completed the Interventional phase.|||||
774886|NCT00752622|Secondary|Number of Participants That Required Treatment Optimization in the Observational Phase|"Participants required treatment-optimization if:
Disease progression/lack of response after entering observational phase; or
Participant was successfully randomized into the interventional phase
The definition of loss of response was as follows:
- An increased HBI score >= 3 points over the week 10 evaluation score and a CDAI score >= 175.
Despite:
having received regular infusions of infliximab every 8 weeks during the observational phase with a maximum interval of no > 10 weeks between each infusion, and
having received previous doses of infliximab of >= 4.7 mg/kg."|Week 54 in the Observational Phase|The eligible (ELIG) population comprised a subset of the enrolled (ENR) population who were not associated with an important protocol violation and who received at least one dose of study medication. Of the 98 participants in the ELIG population, 65 participants entered the observational phase.||Participants|||Number
774887|NCT00752622|Primary|Mean Change From Baseline in Harvey-Bradshaw Index (HBI)|Mean change in HBI score from Baseline to Week 10, 30, and 54. HBI score consists of clinical parameters: general well-being (0-4), abdominal pain (0-3), number of liquid stools per day, abdominal mass (0-3), and complications (score 1 per item). Total score is the sum of individual parameters. Minimum score is 0 and no pre-specified maximum score as it depends on the number of liquid stools. Lower scores indicate better well being. Clinical response/ long-term response is defined as a decrease by 3 or more points from baseline value. Loss of response is defined as an increase of >= 3 points.|Baseline and Evaluation Week 10, Week 30 and Week 54 of the Observational Phase|The eligible (ELIG) population comprised a subset of the enrolled (ENR) population who were not associated with an important protocol violation and who received at least one dose of study medication.||score on a scale||Standard Deviation|Mean
774888|NCT00752622|Primary|Number of Participants Who Had a Clinical Response Using the Crohn's Disease Activity Index (CDAI) at Week 24 in the Interventional Phase|The CDAI incorporates 8 items that are indicators of disease severity. Scores range from 0 to ~600; higher scores indicate worse disease activity. Participants with scores below 150 have inactive disease whereas those with scores above 450 are considered critically ill. Participants provided completed CDAI diary cards and were considered as responders in the interventional phase if their CDAI score at week 24 was decreased by 70 points or greater over their CDAI score at randomization into the interventional phase, or if their week 24 CDAI score is <= 150. Baseline is value at randomization.|Baseline and Week 24 of the Interventional phase|Due to the early termination of the study, no participants completed the Interventional phase.|||||
774889|NCT00752726|Secondary|Selectivity Index at Week 24|The selectivity index (SI) was used as a measure of orlistat’s ability to target abdominal VAT loss compared to total adipose tissue lost. SI was calculated using the following equation: Mean % change in VAT divided by Mean % change in total fat mass.|Baseline to week 24|This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment, only in Orlistat 60 mg group. This analysis was not carried out for placebo group.||Ratio|||Number
774917|NCT00752986|Secondary|Overall Survival||Assessments for survival must be made at the 60 day follow-up visit and then every 3 months, unless the patient withdraws consent.||||||
774890|NCT00752726|Secondary|Change From Baseline to Week 24 in Quality of Life (QoL) Scores.|QoL scores were measured using an Impact of Weight Quality of Life (IWQoL) Questionnaire, which scored the responses at a scale of 1 to 5(1, never true, to 5, always true): QoL scales for physical function, self-esteem, sexual life, public distress, and work were evaluated, and summarized in a total score. A higher value indicated a better quality of life.|Baseline to week 24|This analysis was carried out for the observed ITT population, i.e. ITT subjects who had this post-baseline efficacy assessment.||Score on a Scale||Standard Deviation|Mean
774891|NCT00752726|Secondary|Change From Baseline to Week 24 in Total Calories Expended for Physical Activity|Measurement of physical activity from Paffenbarger questionnaire. The number of caloried expended was representation of activity level: Higher calorie counts indicate higher activity|Baseline to week 24|This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment.||Kilocalorie (kcal)/week||Standard Deviation|Mean
774892|NCT00752726|Secondary|Change From Baseline to Week 24 in Liver Fat|The liver fat was measured by CT scan in Hounsfield Units (HU).|Baseline to week 24|This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment.||Hounsfield Units (HU)||Standard Deviation|Mean
774893|NCT00752726|Secondary|Change From Baseline to Week 24 in Percentage Liver Fat|For Liver fat, Intrahepatic lipids (IHL) were measured by Magnetic Resonance Spectroscopy (MRS).|Baseline to week 24|ITT subset (participants who had this post-baseline efficacy assessment) from one study site was analysed for this parameter.||Percentage (%) IHL||Standard Deviation|Mean
774894|NCT00752726|Secondary|Change From Baseline to Week 24 in Waist Circumference|Waist circumference was measured against the skin, without interference from clothing, at the level midway between the lateral lower rib margin and the iliac crest in standing position.|Baseline to week 24|This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment.||cm||Standard Deviation|Mean
774895|NCT00752726|Secondary|Change From Baseline to Week 24 in Percentage Body Fat|Body fat was assessed through Bioelectrical Impedance Analysis (BIA).|Baseline to week 24|This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment.||Percentage (%) body fat||Standard Deviation|Mean
774896|NCT00752726|Secondary|Change From Baseline to Week 24 in Total Fat Mass|Change in total fat mass was calculated from an average of three measurements at each visit from Echo Magnetic Resonance Imaging (EchoMRI).|Baseline to week 24|This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment.||kg||Standard Deviation|Mean
774897|NCT00752726|Secondary|Change From Baseline to Week 24 in Body Weight|Participants were weighed at least twice until two consecutive measurements were within 0.5 kg of each other and the average of the two measurements was recorded.|Baseline to week 24|This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment.||kg||Standard Deviation|Mean
774898|NCT00752726|Secondary|Change From Baseline to Week 12 in Abdominal VAT Mass|Abdominal VAT mass from baseline to week 12 was measured by CT scan.|Baseline to week 12|This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment.||kg||Standard Deviation|Mean
774899|NCT00752726|Primary|Change From Baseline to Week 24 in Abdominal VAT Mass|VAT was measured by the computed tomography (CT) scan.|Baseline to week 24|This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment.||kg||Standard Deviation|Mean
774900|NCT00752791|Secondary|Percentage of Participants With Dose Adjustments During the Study|The peginesatide dose was adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline during the Titration Period (Weeks 1-19) and Evaluation Period (Weeks 20-25). A dose was classified as adjusted if it was not within 20% of the previous dose. A dose was classified as increased or decreased if it was >20% higher or >20% lower respectively, than the previous dose.|From Week 4 to Week 25|Safety Analysis Set. N indicates the number of patients with study drug administered during the period after excluding the initial dose of study drug and excluding the first dose after a restart of study drug and is the denominator for percentage calculations.||percentage of participants|||Number
774901|NCT00752791|Secondary|Percentage of Participants With Target Hemoglobin of 10.0 to 12.0 g/dL by 4-week Intervals|Percentage of participants with mean hemoglobin levels falling between the target level of 10.0 to 12.0 g/dL during 4-week study intervals. Hemoglobin was measured every 2 weeks during the Titration Period (Weeks 1-19) and weekly during the Evaluation Period (Weeks 20-25). 95% Confidence Intervals were calculated from the normal approximation with continuity correction.|Up to 25 weeks.|Full analysis set where data was available for each time interval (indicated by N).||percentage of participants||95% Confidence Interval|Number
774902|NCT00752791|Secondary|Mean Hemoglobin During 4-week Intervals|Hemoglobin was measured every 2 weeks during the Titration Period (Weeks 1-19) and weekly during the Evaluation Period (Weeks 20-25). One patient did not have central lab hemoglobin value during a regularly scheduled visit during weeks 2-5.|Up to 25 weeks.|Full Analysis Set where data was available for each time interval (indicated by N).||g/dL||Standard Deviation|Mean
774903|NCT00752791|Secondary|Percentage of Participants With Red Blood Cell Transfusions|The percentage of participants who received one or more red blood cell transfusions, including packed red blood cells and whole blood transfusions, during the Titration Period (Weeks 1 - 19) and Evaluation Period (Weeks 20 -25). 95% Confidence Intervals were calculated from the normal approximation with continuity correction. One patient had the last study visit during the titration period and the transfusion after the titration period. This patient is excluded from the summary of evaluation period.|Up to 25 weeks.|Full Analysis Set.||percentage of participants||95% Confidence Interval|Number
774904|NCT00752791|Secondary|Percentage of Participants With a Change in Hemoglobin From Baseline to the Evaluation Period Within 1 g/dL|Percentage of participants with a mean change in Hemoglobin between Baseline (the mean of the 4 most recent hemoglobin values prior to enrollment and the hemoglobin on the day of enrollment) and the Evaluation Period (mean hemoglobin from measured at Weeks 20 to 25) of less than or equal ± 1 g/dL. The 95% confidence interval was calculated from the normal approximation with continuity correction.|Baseline and Week 20 to Week 25.|Full analysis set where data was available.||percentage of participants||95% Confidence Interval|Number
774918|NCT00752986|Secondary|Time-To-Progression, Progression-Free Survival, Objective Tumor Response Rate (CR+PR), Disease Control Rate (CR+PR+SD) and Duration of Response (DOR)||Restaging (RECIST) is carried out at screening and every 3 months during the study until 1 year and than every 6 months until objective disease progression.||||||
774905|NCT00752791|Secondary|Percentage of Participants With Hemoglobin Within the Target Range of 10.0 to 12.0 g/dL During the Evaluation Period|"Mean hemoglobin was calculated from measurements taken during the Evaluation Period (Week 20 to Week 25). The target hemoglobin range was 10.0 to 12.0 g/dL.
The 95% confidence interval was calculated from the normal approximation with continuity correction."|Week 20 to Week 25.|Full analysis set where data was available.||percentage of participants||95% Confidence Interval|Number
774906|NCT00752791|Primary|Mean Change in Hemoglobin Between Baseline and the Evaluation Period|The primary efficacy endpoint was the mean change in Hemoglobin between Baseline (the mean of the 4 most recent hemoglobin values prior to Enrollment and the hemoglobin on the day of Enrollment) and the Evaluation Period (mean hemoglobin from Weeks 20 to 25).|Baseline and Week 20 to Week 25.|The Full Analysis Set included all patients who received at least 1 dose of peginesatide injection and where data was available at both time points (indicated by N).||g/dL||Standard Deviation|Mean
774907|NCT00752895|Secondary|Number of Antibiotic Use Days|An antibiotic day was defined as a day on which the subject took one or more antibiotics between January and March.|3 months|Participants who returned respiratory symptom and antibiotic use diaries. Note that a few participants failed to provide antibiotic use diaries so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with adverse event data.||days||Standard Deviation|Mean
774908|NCT00752895|Primary|Acute Respiratory Infection (ARI) Days|An ARI day was defined as any day for which the subject experienced one or more respiratory symptoms (cough, sore throat, nasal or sinus congestion, or runny nose) and one or more systemic symptoms (feverishness, chills/sweats, myalgia (muscle aches), fatigue, headache, poor endurance or increased shortness of breath) between January and March.|3 months|Participants who returned a respiratory symptom diary between January and March. Note that a few participants failed to provide respiratory diaries so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with adverse event data.||days||Standard Deviation|Mean
774909|NCT00752973|Secondary|Evaluation of the Local Safety of Malathion Gel, 0.5% Based Upon Reported Adverse Events and Observed Scalp Reactions.|To evaluate the safety of Malathion Gel, 0.5% based upon reported adverse events and observed scalp reactions. Additional safety assessments included eye Irritation.|Participants were followed for a minimum of 14 days (1 treatment) and a maximum of 21 days (2 treatments)|A total of 12 subjects were enrolled. All of them used the study drug for at least one dose of the treatment. At Day 0 the study drug was to be used. At Day 7 if subject presented with live lice they were provided a second treatment. The subjects may used it for 1 (for subjects not requiring retreatment) or 2 (for retreated subjects).||participants|||Number
774910|NCT00752973|Primary|Participants Clinically Cured of Head Lice 14 Days After Last Treatment|No live lice (including adults and nymphs) and nits at Day 7±1 and final lice assessment on either Day 14 (subjects not requiring retreatment) or Day 21 (for retreated subjects).|Day 7±1 and Day 14 or Day 21|No statistical analysis provided for Clinical Cure||participants cured of lice|||Number
774911|NCT00752973|Primary|Participants With the Clinical Evidence of Cholinesterase Inhibition|"Participants with any of the following symptoms of cholinesterase inhibition as numbered below were considered to have Clinical evidence of cholinesterase inhibition :
Abnormal heart rate.
Diarrhea or abdominal cramps.
Inappropriate sweating.
Pupillary miosis (constriction).
Respiratory difficulty such as chest tightness or wheezing.
One participants had wheezing as medical history which continued without increase in severity throughout the treatment."|at 24 hrs (Day 1)|||percentage of participants|||Number
774912|NCT00752973|Primary|Participants With the Clinical Evidence of Cholinesterase Inhibition|"Participants with any of the following symptoms of cholinesterase inhibition as numbered below were considered to have Clinical evidence cholinesterase inhibition :
Abnormal heart rate.
Diarrhea or abdominal cramps.
Inappropriate sweating.
Pupillary miosis (constriction).
Respiratory difficulty such as chest tightness or wheezing.
One participants had wheezing as medical history which continued without increase in severity throughout the treatment."|at 1 hr (Day 0)|||percentage of participants|||Number
774913|NCT00752973|Primary|Participants With the Clinical Evidence of Cholinesterase Inhibition|"Participants with any of the following symptoms of cholinesterase inhibition as numbered below were considered to have Clinical evidence of cholinesterase inhibition.
Abnormal heart rate.
Diarrhea or abdominal cramps.
Inappropriate sweating.
Pupillary miosis (constriction).
Respiratory difficulty such as chest tightness or wheezing.
One participant had wheezing as medical history which continued without increase in severity throughout the treatment."|at Baseline|||percentage of participants|||Number
774914|NCT00752973|Primary|Participants With a Change in Cholinesterase Level at 24 Hrs (1 Day).|"Each patient was assessed at Day 1 and the mean percent reduction in plasma and RBC cholinesterase activity from baseline to 24 hr after application was calculated and accompanied by 95% confidence intervals.
Concentration of RBC-cholinesterase (RBC-ChE) and plasma cholinesterase were obtained at baseline, at 1 hr (Day 0) and at 24 hrs (Day 1) after the application of the treatment.
Mean percent reduction = (Post treatment value – Baseline)/ Baseline x100."|Change from baseline to 24 hrs (1 day)|11 subjects with obtained blood sample. subject 01-004: At Visit 2, Day 1 Lab could not perform testing due to sample not suitable for testing. Because only 2ml blood was able to collected after multiple attempts.||percentage change in cholinesterase||95% Confidence Interval|Mean
774915|NCT00752973|Primary|Participants With a Change in Cholinesterase Level at 1 Hour (Day 0).|"Each patient (aged 6 – 24 months) was assessed at 1 hour (Day 0). The mean percent change (reduction) in plasma and RBC cholinesterase activity from baseline to 1 hr after application was calculated and accompanied by 95% confidence intervals.
If the half-widths of the derived confidence intervals are sufficiently narrow, it will demonstrate that any observed reductions in plasma and RBC cholinesterase activity fall within established safety guidelines.
Concentration of RBC-cholinesterase (RBC-ChE) and plasma cholinesterase were obtained at baseline, at 1 hr (Day 0) and at 24 hrs (Day 1) after the application of the treatment.
Mean percent change (reduction) = (Post treatment value – Baseline)/ Baseline x100."|Change from Baseline to 1 hour|"10 subjects with obtained blood sample. subject 01-003: Study coordinator was unable to obtain blood sample post treatment at Visit 1, Day 0.
subject 01-004: At Visit 1 Day 0 (post treatment), Blood sample could not be obtained even after two attempts."||percentage change in cholinesterase||95% Confidence Interval|Mean
774916|NCT00752986|Secondary|Incidence and Type of Adverse Events (AEs), Clinically Significant Laboratory or Vital Sign Abnormalities and Electrocardiographic (ECG) Changes||Continuous assessment of safety.||||||
774925|NCT00753220|Primary|Maximum Tolerated Dose (MTD)|"PROTOCOL EXCERPT: The primary objective of the Phase I Portion of this study is the determination of the maximum tolerated dose (MTD) of intratumorally injected study agent VDC2008 administered following cryoablation of the prostate, and pre- and post-treatment with a low-dose cyclophosphamide therapy, as determined by toxicity and adverse event monitoring following treatment of metastatic androgen-independent prostate cancer.
ADDITIONAL INFORMATION: MTD was not reached by any study participant prior to end of the study. Additional participants would have been necessary to determine MTD."|Up to 1 year|||intratumorally delivered cells|||Number
774926|NCT00753272|Secondary|Number of Seroconverted Subjects for HI Antibodies Against Each of the 3 Vaccine Influenza Strains|In the lot-to-lot subset of subject in the FluGN Group. Vaccine strains assessed were A/Brisbane/59/2077, A/Uruguay/716/2007 and B/Brisbane/3/2007. Seroconversion is defined as the number of subjects with pre-vaccination HI titer (Day 0) < 1:10 and post-vaccination titer (Day 21) ≥ 1:40 or a pre-vaccination HI titer (Day 0) ≥ 1:10 and fold-increase (post/pre) ≥ 4.|At Day 21 of the first year (2008/2009) of the study.|The One-Dose According-To-Protocol immunogenicity cohort for the lot-to-lot consistency subset included all subjects from the One-Dose ATP cohort for immunogenicity included in the lot-to-lot subset.||Subjects|||Number
774927|NCT00753272|Secondary|Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains.|Vaccine strains assessed were A/Brisbane/59/2077, A/Uruguay/716/2007 and B/Brisbane/3/2007. Titers were expressed as geometric mean titers calculated on all subjects for 600 subjects in the persistence subset only.|At Days 0 (pre-vaccination Dose 2), 21 (post-vaccination Dose 2) and 180 (post-vaccination Dose 2) of the second year (2009/2010) of the study|The Two-Dose According-To-Protocol cohort for persistence included evaluable subjects for whom data concerning immunogenicity outcome measures were available in terms of antibodies against at least one study vaccine antigen component at Day 180 of the second year of the study.||Titers||95% Confidence Interval|Geometric Mean
774928|NCT00753272|Secondary|Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains.|Vaccine strains assessed were A/Brisbane/59/2077, A/Uruguay/716/2007 and B/Brisbane/3/2007. Titers were expressed as geometric mean titers calculated on all subjects for 600 subjects in the persistence subset only.|At Days 0 (pre-vaccination Dose 1), 21 (post-vaccination Dose 1) and 180 (post-vaccination Dose 1) of the first year (2008/2009) of the study|The One-Dose According-To-Protocol cohort for persistence included evaluable subjects for whom data concerning immunogenicity outcome measures were available in terms of antibodies against at least one study vaccine antigen component at Day 180 of the first year of the study.||Titers||95% Confidence Interval|Geometric Mean
774929|NCT00753272|Secondary|Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains|Vaccine strains assessed were A/Brisbane/59/2077, A/Uruguay/716/2007 and B/Brisbane/3/2007. Titers were expressed as geometric mean titers calculated on all subjects in the immunogenicity subset of subjects.|At Days 0 (pre-vaccination Dose 2) and 21 (post-vaccination Dose 2) of the second year (2009/2010) of the study|The Two-Dose According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available in terms of antibodies against at least one study vaccine antigen component at Day 21 of the second year of the study.||Titers||95% Confidence Interval|Geometric Mean
774930|NCT00753272|Secondary|Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains.|Vaccine strains assessed were A/Brisbane/59/2077, A/Uruguay/716/2007 and B/Brisbane/3/2007. Titers were expressed as geometric mean titers calculated on all subjects in the immunogenicity subset of subjects.|At Days 0 (pre-vaccination Dose 1) and 21 (post-vaccination Dose 1) of the first year (2008/2009) of the study|The One-Dose According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available in terms of antibodies against at least one study vaccine antigen component at Day 21 of the first year of the study.||Titers||95% Confidence Interval|Geometric Mean
774931|NCT00753272|Secondary|Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited AEs With Medically Attended Visit.|For each solicited and unsolicited symptom the subject experienced, the subjects were asked if they received medical attention defined as hospitalisation, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Grade 3 = event that prevented normal everyday activities. Related = event assessed by the investigator as causally related to the study vaccination.|Within 180 days (Days 0-179) after the second dose (Year 2009/2010)|The Two-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented in each year of the study and included in the safety subset.||Subjects|||Number
774932|NCT00753272|Secondary|Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited AEs With Medically Attended Visit|For each solicited and unsolicited symptom the subject experienced, the subjects were asked if they received medical attention defined as hospitalisation, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Grade 3 = event that prevented normal everyday activities. Related = event assessed by the investigator as causally related to the study vaccination.|Within 180 days (Days 0-179) after the first dose (Year 2008/2009)|The One-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented during the first year of the study and included in the safety subset.||Subjects|||Number
774933|NCT00753272|Secondary|Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs).|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Grade 3 = event that prevented normal, everyday activities. Related = event assessed by the investigator as causally related to the study vaccination.|Within 21 days (Days 0-20) after the second dose (Year 2009/2010)|The Two-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented in each year of the study and included in the safety subset.||Subjects|||Number
775216|NCT00755235|Primary|20-Item Symptom Checklist Depression Scale|20-item depression severity scalse adapted from longer SCL-90. Mean score ranges from 0 to 4 with scores above 1.5 indicating moderate depression.|Measured at baseline and after 6 months of treatment|Analysis included all participants participating in outcome assessment||units on a scale||Standard Deviation|Mean
774934|NCT00753272|Secondary|Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs).|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Grade 3 = event that prevented normal, everyday activities. Related = event assessed by the investigator as causally related to the study vaccination.|Within 21 days (Days 0-20) after the first dose (Year 2008/2009)|The One-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented during the first year of the study and included in the safety subset.||Subjects|||Number
774935|NCT00753272|Secondary|Number of Days With Any Grade of Solicited General Symptoms.|Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering and temperature.|During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010)|The Two-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented in each year of the study and included in the safety subset.||Days||Full Range|Mean
774936|NCT00753272|Secondary|Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms.|Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering and temperature (defined as oral temperature equal to or above (≥) 38.0 degrees Celsius). Any = incidence of a particular symptom regardless of intensity grade or relationship to vaccination. Grade 3 = general symptom which prevented normal everyday activities. Related = general symptom assessed by the investigator as causally related to the study vaccination. Grade 3 temperature = oral temperature ≥39.0°C - ≤ 40.0°C.|During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010)|The Two-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented in each year of the study and included in the safety subset.||Subjects|||Number
774937|NCT00753272|Secondary|Number of Days With Any Grade of Solicited General Symptoms|Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering and temperature.|During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009)|The One-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented during the first year of the study and included in the safety subset.||Days||Full Range|Mean
774938|NCT00753272|Secondary|Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Symptoms|Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering and temperature (defined as oral temperature equal to or above (≥) 38.0 degrees Celsius). Any = incidence of a particular symptom regardless of intensity grade or relationship to vaccination. Grade 3 = general symptom which prevented normal everyday activities. Related = general symptom assessed by the investigator as causally related to the study vaccination. Grade 3 temperature = oral temperature ≥39.0°C - ≤ 40.0°C.|During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009)|The One-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented during the first year of the study and included in the safety subset.||Subjects|||Number
774939|NCT00753272|Secondary|Number of Days With Any Grade of Solicited Local Symptoms.|Solicited local symptoms assessed were ecchymosis, pain, redness and swelling.|During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010)|The Two-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented in each year of the study and included in the safety subset.||Days||Full Range|Mean
774940|NCT00753272|Secondary|Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Symptoms|Solicited local symptoms assessed were ecchymosis, pain, redness and swelling. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = considerable pain at rest that prevented normal everyday activities. Grade 3 ecchymosis/redness/swelling = ecchymosis/redness/swelling above 100 millimeter|During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010)|The Two-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented in each year of the study and included in the safety subset.||Subjects|||Number
774941|NCT00753272|Secondary|Number of Days With Any Grade of Solicited Local Symptoms|Solicited local symptoms assessed were ecchymosis, pain, redness and swelling|During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009)|The One-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented during the first year of the study and included in the safety subset.||Days||Full Range|Mean
774942|NCT00753272|Secondary|Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Symptoms.|Solicited local symptoms assessed were ecchymosis, pain, redness and swelling. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = considerable pain at rest that prevented normal everyday activities. Grade 3 ecchymosis/redness/swelling = ecchymosis/redness/swelling above 100 millimeter|During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009)|The One-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented during the first year of the study and included in the safety subset.||Subjects|||Number
774943|NCT00753272|Secondary|Number of Subjects Reporting Any and Related to Vaccination Serious Adverse Events (SAEs).|"SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Related = event assessed by the investigator as causally related to the study vaccination"|During the entire study period (during the 365 days of follow-up after each vaccination at Year 2008/2009 and Year 2009/2010)|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.||Subjects|||Number
775000|NCT00753454|Primary|Percentage of Subjects With At Least One Treatment-emergent Serious Adverse Event (SAE) During The Study Period|"A Serious Adverse Event is any untoward medical occurrence that at any dose
results in death,
is life threatening,
requires in-patient hospitalization or prolongation of existing hospitalization,
results in persistent or significant disability/incapacity
is a congenital anomaly/birth defect"|From Entry Visit up to approximately 60 weeks|Of the 168 subjects in the Full Analysis Set (FAS), 168 are included in this analysis.||percentage of subjects|||Number
774944|NCT00753272|Secondary|Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Adverse Events (AEs) of Specific Interest Including Autoimmune Disease (AID).|"Adverse events of specific interest for safety monitoring are a subset of AEs that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.
Grade 3 = event that prevented normal everyday activities Related = event assessed by the investigator as causally related to the study vaccination"|During the entire study period (during the 365 days of follow-up after each vaccination at Year 2008/2009 and Year 2009/2010)|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.||Subjects|||Number
774945|NCT00753272|Secondary|Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Adverse Events (AEs) of Specific Interest Including Autoimmune Disease (AID).|"Adverse events of specific interest for safety monitoring are a subset of AEs that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.
Grade 3 = event that prevented normal everyday activities Related = event assessed by the investigator as causally related to the study vaccination"|Within 365 days after the second dose (from Dose 1 at Day 0 up to Day 365 for the Year 2009/2010)|The Two-Dose Total Vaccinated cohort included all subjects with one vaccine administration documented in each year of the study||Subjects|||Number
774946|NCT00753272|Secondary|Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Adverse Events (AEs) of Specific Interest Including Autoimmune Disease (AID).|"Adverse events of specific interest for safety monitoring are a subset of AEs that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.
Grade 3 = event that prevented normal everyday activities Related = event assessed by the investigator as causally related to the study vaccination"|Within 365 days after the first dose (from Dose 1 at Day 0 up to Day 365 for the Year 2008/2009)|The One-Dose Total Vaccinated cohort included all subjects with one vaccine administration documented during the first year of the study.||Subjects|||Number
774947|NCT00753272|Secondary|Number of Subjects Reporting Hospitalization Due to Respiratory Diseases After the First Dose of Vaccine|Respiratory disease: A diagnosis of respiratory disease included: acute respiratory infections, other diseases of upper respiratory tract, pneumonia and influenza, chronic obstructive pulmonary disease and allied conditions, pneumoconioses and other lung diseases due to external agents, other diseases of respiratory system. In case the event has a fatal outcome, the diagnosis can also be confirmed by autopsy.|During the influenza peak season within the first surveillance period (the influenza peak season being defined per country, falling somewhere between mid November 2008 to end of April 2009)|The One-Dose According-To-Protocol cohort for efficacy for peak season included all subjects from the One-Dose ATP cohort for efficacy who did not drop out from the study before the start of their first influenza peak season.||Subjects|||Number
774948|NCT00753272|Secondary|Number of Subjects Reporting All-cause Death After the First Dose of Vaccine.|The influenza peak season = period during the study with the highest incidence of any matching or drift influenza strain relative to the vaccine strains (i.e. not emerging novel human influenza strain like H1N1v).|During the influenza peak season within the first surveillance period (the influenza peak season being defined per country, falling somewhere between mid November 2008 to end of April 2009)|The One-Dose According-To-Protocol cohort for efficacy for peak season included all subjects from the One-Dose ATP cohort for efficacy who did not drop out from the study before the start of their first influenza peak season.||Subjects|||Number
774949|NCT00753272|Secondary|Number of Subjects Reporting Pneumonia or Clinical Influenza After the First Dose of Vaccine.|"Clinical influenza= An ILI episode (with an ILI onset from the 15th of November until the end of the surveillance period) with at least simultaneously fever (oral temperature of ≥37.8 degrees Celsius) and cough.
The influenza peak season = period during the study with the highest incidence of any matching or drift influenza strain relative to the vaccine strains (i.e. not emerging novel human influenza strain like H1N1v)."|During the influenza peak season within the first surveillance period (the influenza peak season being defined per country, falling somewhere between mid November 2008 to end of April 2009)|The One-Dose According-To-Protocol cohort for efficacy for peak season included all subjects from the One-Dose ATP cohort for efficacy who did not drop out from the study before the start of their first influenza peak season.||Subjects|||Number
774950|NCT00753272|Secondary|Number of Subjects Reporting Culture-confirmed Influenza A and/or B Infection.|Occurrence of culture-confirmed influenza A and/or B infection, due to any matching or drift influenza strain relative to the vaccine strains (i.e. not emerging novel human influenza strain like H1N1v). Culture-confirmed influenza (CCI) was defined as an episode of ILI occurring after the administration of the study vaccine for which a nasal and throat swab specimen yields influenza virus A and/or B by viral culture analysis.|During the whole surveillance period (from mid November 2008 to end of April 2009 and from mid November 2009 to end of April 2010)|The According-To-Protocol cohort for efficacy included all eligible subjects from the Total Vaccinated cohort (e.g. who complied with the protocol, with no elimination criteria assigned during the study), who had started their first surveillance period, who had not received a seasonal influenza vaccine not foreseen in the protocol.||Subjects|||Number
774951|NCT00753272|Secondary|Number of Subjects Reporting Polymerase Chain Reaction (PCR)-Confirmed Influenza A and/or B Infection.|Occurrence of PCR-confirmed influenza A and/or B infection, due to any matching or drift influenza strain relative to the vaccine strains (i.e. not emerging novel human influenza strain like H1N1v). PCR-confirmed influenza (PCI) was defined as an episode of influenza-like illness (ILI) occurring after the administration of the study vaccine for which a nasal and throat swab specimen yields influenza virus A and/or B by reverse transcription polymerase chain reaction (RT-PCR) analysis.|During the whole surveillance period (from mid November 2008 to end of April 2009 and from mid November 2009 to end of April 2010)|The According-To-Protocol cohort for efficacy included all eligible subjects from the Total Vaccinated cohort (e.g. who complied with the protocol, with no elimination criteria assigned during the study), who had started their first surveillance period, who had not received a seasonal influenza vaccine not foreseen in the protocol.||Subjects|||Number
775031|NCT00753636|Secondary|Safety of the Standard Titration Schedule in PD Population as Measured by the Number of Patients That Are Able to Increase the Dose to 20 mg Daily||1 year|||Participants|||Number
775032|NCT00753636|Primary|Tolerability of Isradipine Based on the Number of Participants That Complete the Study||1 year|||Participants|||Number
774952|NCT00753272|Primary|Serum Hemagglutination-inhibition (HI) Antibody Titers, Against Each of the 3 Vaccine Influenza Strains, in the FluNG Groups.|Vaccine strains assessed were A/Brisbane/59/2077, A/Uruguay/716/2007 and B/Brisbane/3/2007. Titers were expressed as geometric mean titers calculated on all subjects in the lot-to-lot subset of subjects.|At Days 0 (pre-vaccination Dose 1) and 21 (post-vaccination Dose 1) of the first year (2008/2009) of the study|The One-Dose According-To-Protocol immunogenicity cohort for the lot-to-lot consistency subset included all subjects from the One-Dose ATP cohort for immunogenicity included in the lot-to-lot subset.||Titers||95% Confidence Interval|Geometric Mean
774953|NCT00753272|Primary|Number of Subjects Reporting Polymerase Chain Reaction (PCR)-Confirmed Influenza A and/or B Infection.|Occurrence of PCR-confirmed influenza A and/or B infection, due to any matching or drift influenza strain relative to the vaccine strains (i.e. not emerging novel human influenza strain like H1N1v). PCR-confirmed influenza (PCI) was defined as an episode of influenza-like illness (ILI) occurring after the administration of the study vaccine for which a nasal and throat swab specimen yields influenza virus A and/or B by reverse transcription polymerase chain reaction (RT-PCR) analysis.|After the first dose during the corresponding surveillance period (from mid November 2008 to the end of April 2009 (end of influenza season))|The One-Dose According-To-Protocol cohort for efficacy included eligible subjects from the One-Dose Total Vaccinated cohort (e.g. who complied with the protocol, with no elimination criteria assigned during the study), who had started their first surveillance period, who had not received a seasonal influenza vaccine not foreseen in the protocol.||Subjects|||Number
774954|NCT00753298|Primary|Subject's Sensation When Using Test Catheter|Subject's sensation when using test catheter, measured by mean score on a scale from 1 (Comfortable) to 6 (Severe pain)|At 4 weeks|||Score on scale||Standard Deviation|Mean
774955|NCT00753298|Primary|Subject's General Satisfaction With Test Catheter|Subject's general satisfaction with test catheter, measured by mean score on a scale from 1 (Very satisfied) to 5 (Absolutely not satified)|At 4 weeks|||Score on scale||Standard Deviation|Mean
774956|NCT00753298|Primary|Subject's Perception Regarding Handling of Test Catheter After Withdrawal|Subject's perception regarding handling of test catheter after withdrawal, measured by mean score on a scale from 1 (Easy) to 5 (Troublesome)|At 4 weeks|||Score on scale||Standard Deviation|Mean
774957|NCT00753298|Primary|Subject's Perception Regarding Handling of Test Catheter at Withdrawal|Subject's perception regarding handling of test catheter at withdrawal, measured by mean score on a scale from 1 (Easy) to 5 (Troublesome)|At 4 weeks|||Score on scale||Standard Deviation|Mean
774958|NCT00753298|Primary|Subject's Perception Regarding Handling of Test Catheter at Insertion|Subject's perception regarding handling of test catheter at insertion, measured by mean score on a scale from 1 (Easy) to 5 (Troublesome)|At 4 weeks|||Score on scale||Standard Deviation|Mean
774959|NCT00753298|Primary|Subject's Perception Regarding Handling of Test Catheter Before Insertion|Subject's perception regarding handling of test catheter before insertion, measured by mean score on a scale from 1 (Easy) to 5 (Troublesome)|At 4 weeks|||Score on scale||Standard Deviation|Mean
774960|NCT00753337|Secondary|All Cause Mortality|Subjects are considered unevaluable for all cause mortality at 9 months if a) withdrawn before 240 days or b) lost to follow-up before 240 days and had no contact thereafter.|9 months|Intent to Treat population||participants|||Number
774961|NCT00753337|Secondary|All Cause Mortality|Subjects are considered unevaluable for all cause mortality at 30 days if a) withdrawn before 25 days or b) lost to follow-up before 25 days and had no contact thereafter.|30 days|Intent to Treat population||participants|||Number
774962|NCT00753337|Secondary|Hemodynamic Success|Hemodynamic success defined as an improvement in ankle-brachial Index (ABI) or toe brachial index (TBI) > 0.10 over pre-procedure level and not deteriorated by > 0.15 from first post-procedure level.|9 months|Intent to Treat population||percentage of limbs|Participants||Number
774963|NCT00753337|Secondary|Hemodynamic Success|Hemodynamic success defined as an improvement in ankle-brachial Index (ABI) or toe brachial index (TBI) > 0.10 over pre-procedure level and not deteriorated by > 0.15 from first post-procedure level.|30 days|Intent to Treat population||percentage of limbs|Participants||Number
774964|NCT00753337|Secondary|Clinical Success|Clinical success defined as the improvement of Fontaine classification by at least one stage above the pretreated (pre-procedure) clinical value. The reported values are a percentage of limbs showing improvement.|9 months|Intent to Treat population||percentage of limbs|Participants||Number
774965|NCT00753337|Secondary|Clinical Success|Clinical success defined as the improvement of Fontaine classification by at least one stage above the pretreated (pre-procedure) clinical value. The reported values are a percentage of limbs showing improvement.|30 days|Intent to Treat population||percentage of limbs|Participants||Number
774966|NCT00753337|Secondary|Procedure Success|Procedure Success defined as angiographic evidence of <30% final residual stenosis of the target lesion after stent placement and no occurrence of a procedure related MAE prior to hospital discharge (for subjects with more than one lesion stented the worse case is counted)|9 months|Intent to Treat population||percentage of participants|||Number
774967|NCT00753337|Secondary|Lesion Success|Lesion Success defined as angiographic evidence of <30% final residual stenosis of the target lesion using any percutaneous method such as baloon angioplasy or other stent.|9 months|Intent to Treat population||percentage of lesions|Participants||Number
774968|NCT00753337|Secondary|Device Success|Device Success defined as angiographic evidence of <30% final residual stenosis of the target lesion using only the assigned device.|9 months|Intent to Treat population||percentage of lesions|Participants||Number
774969|NCT00753337|Secondary|Primary Patency Rate at 9 Months|Primary patency was defined as the blood flow through the treated vessel segment into the distal vasculature (e.g. the common femoral artery and/or the deep femoral artery) as evidenced by duplex ultrasound scan at 9 months for all subjects enrolled with evaluable duplex scans.|9 months|Intent to Treat population||percentage of lesions|Participants||Number
774970|NCT00753337|Primary|Major Adverse Events (MAE), Measured as Device and/or Procedure Related Death, Target Limb Loss and/or Clinically Driven Target Lesion Revascularization (TLR) or Target Vessel Revascularization (TVR).|Percentage based on number of evaluable subjects for MAE. Subjects are considered unevaluable for MAE to 9 months if a) withdrawn before 240 days without having MAE events or b) lost to follow-up before 240 days without having MAE events and had no contact thereafter or c) any device and/or procedure-unrelated death before 240 days without having MAE events.|9 months|Intent to Treat population (ITT)||percentage of participants|||Number
774974|NCT00753415|Secondary|Number of Participants With Immunologic Response to V934/V935 (Immunologic Response Rate)|An Enzyme-Linked Immunosorbent Spot (ELISPOT) assay was planned to be used to demonstrate a cell mediated immune response to V935 and/or V934 in vaccinated participants. Collection of Peripheral Blood Mononuclear Cells (PBMCs) and serum took place at baseline (Screening and pre-vaccination Day 1), and various time points post vaccination across the three distinct regimens to be tested. A positive immune response was to be defined by a minimum number of spot-forming cells per million PBMC (SFC/10^6 PBMCs) for the antigen well and a minimum n-fold increase in the antigen well over the control well.|From pre-vaccination to Week 69|Planned analysis for the secondary endpoint of Immunologic Response Rate was not performed due to study de-prioritization.|||||
774975|NCT00753415|Primary|Number of Participants With Adverse Events (AEs)|This analysis includes the number of participants with AEs and serious AEs (SAEs) during the Treatment Period plus the Acute Follow-up (FU) Period (up to 30 days following last vaccination). An AE was defined as any unfavorable or unintended change in the structure, function or chemistry of the body temporally associated with the use of the product, whether or not considered related to the product, including any worsening of a preexisting condition which was temporally associated with the product. An SAE was defined as an AE resulting in death, was life-threatening, resulted in or prolonged hospitalization, was a congenital anomaly, a cancer, an overdose or other important medical event.|Day 1 up to 30 days following the last vaccination (up to 77 weeks); Treatment Period + Acute Follow-up (FU) Period|All Participants as Treated (APaT) population; all participants who received at least one vaccination.||Participants|||Number
774976|NCT00753415|Primary|Number of Participants With Dose-Limiting Toxicity (DLT)|DLT was defined as a vaccine- or EP-related adverse event (AE) including the following: Hematological (Grade 3 neutropenia with fever, Grade 4 neutropenia ≥5 days, Grade 4 thrombocytopenia) or non-hematological AE, Grade 3, 4 or 5 with the exception of Grade 3 nausea, vomiting, diarrhea or serum glutamic oxaloacetic transaminase (SGOT) elevation, alopecia, Grade 3/4 creatinine phosphokinase (CPK) elevation or inadequately treated hypersensitivity. Any Grade 3/4 related AE that failed to return to ≤Grade 1 or baseline within 14 days was also considered a DLT.|Day 1 up to 30 days following the last vaccination (up to 77 weeks); Treatment Period + Acute Follow-up (FU) Period|Evaluable patients who completed all scheduled vaccinations were included in the DLT analysis.||Participants|||Number
774977|NCT00753454|Secondary|Change From Baseline in PtGADA (Patient's Global Assessment of Disease Activity) at Completion/Withdrawal Visit|Change from Baseline in Patient’s Global Assessment of Disease Activity-VAS (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as the value at Completion/Withdrawal minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 140 are included in this analysis.
Data was not available for 28 subjects."||units on a scale||Standard Deviation|Mean
774978|NCT00753454|Secondary|Change From Baseline in PtAAP (Patient's Assessment of Arthritis Pain) at Completion/Withdrawal Visit|Change from Baseline in Patient’s Assessment of Arthritis Pain-VAS (0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain) is computed as the value at Completion/Withdrawal minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 140 are included in this analysis.
Data was not available for 28 subjects."||units on a scale||Standard Deviation|Mean
774979|NCT00753454|Secondary|Change From Baseline in MCS (Short Form 36-item Health Survey Mental Component Summary) at Completion/Withdrawal Visit|MCS norm-based scores are calculated based upon the following 8 domain scores, Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, and range from -9 to 82, where 50 represents the normative value. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 139 are included in this analysis.
Data was not available for 29 subjects."||units on a scale||Standard Deviation|Mean
774980|NCT00753454|Secondary|Change From Baseline in PCS (Short Form 36-item Health Survey Physical Component Summary) at Completion/Withdrawal Visit|PCS norm-based scores are calculated based upon the following 8 domain scores, Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, and range from 1 to 81, where 50 represents the normative value. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 139 are included in this analysis.
Data was not available for 29 subjects."||units on a scale||Standard Deviation|Mean
774981|NCT00753454|Secondary|Change From Baseline in Mental Health (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 141 are included in this analysis.
Data was not available for 27 subjects."||units on a scale||Standard Deviation|Mean
774982|NCT00753454|Secondary|Change From Baseline in Role Emotional (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 141 are included in this analysis.
Data was not available for 27 subjects."||units on a scale||Standard Deviation|Mean
774983|NCT00753454|Secondary|Change From Baseline in Social Functioning (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 143 are included in this analysis.
Data was not available for 25 subjects."||units on a scale||Standard Deviation|Mean
774984|NCT00753454|Secondary|Change From Baseline in Vitality (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 141 are included in this analysis.
Data was not available for 27 subjects."||units on a scale||Standard Deviation|Mean
774985|NCT00753454|Secondary|Change From Baseline in General Health (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 141 are included in this analysis.
Data was not available for 27 subjects."||units on a scale||Standard Deviation|Mean
774986|NCT00753454|Secondary|Change From Baseline in Bodily Pain (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 143 are included in this analysis.
Data was not available for 25 subjects."||units on a scale||Standard Deviation|Mean
774987|NCT00753454|Secondary|Change From Baseline in Role Physical (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 143 are included in this analysis.
Data was not available for 25 subjects."||units on a scale||Standard Deviation|Mean
774988|NCT00753454|Secondary|Change From Baseline in Physical Functioning (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 143 are included in this analysis.
Data was not available for 25 subjects."||units on a scale||Standard Deviation|Mean
774989|NCT00753454|Secondary|Change From Baseline in FAS (Fatigue Assessment Scale) at Completion/Withdrawal Visit|Change from Baseline in Fatigue Assessment scale (0 to 10, 0 is “No Fatigue” and 10 is “Fatigue as bad as you can imagine”) is computed as the value at Completion/Withdrawal minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 139 are included in this analysis.
Data was not available for 29 subjects."||units on a scale||Standard Deviation|Mean
774990|NCT00753454|Secondary|Change From Baseline in HAQ-DI (Health Assessment Questionnaire-Disability Index) at Completion/Withdrawal Visit|HAQ-DI is derived based on the mean of individual scores in 8 categories of daily living actives (using 20 questions). Each question is scored 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do). Thus, the mean also has a range from 0-3. Change from Baseline is computed as the value at Completion/Withdrawal minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 142 are included in this analysis.
Data was not available for 26 subjects."||units on a scale||Standard Deviation|Mean
774991|NCT00753454|Secondary|Percentage of Subjects With CDAI (Clinical Disease Activity Index) Remission (CDAI ≤2.8) at Completion/Withdrawal Visit|"CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm), and Investigator’s Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI).
The range for the CDAI is 0 - 76 with a lower CDAI score indicating improvement in activity and a higher score indicating a decline activity."|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 152 are included in this analysis.
Data was not available for 16 subjects."||percentage of subjects|||Number
775100|NCT00754338|Primary|Comfort|Subjective comfort ratings on analog scale (0= very poor comfort; 100= excellent comfort), self report by subject based on single criterion 'comfort'.|4 weeks|analysis was per protocol||Units on a scale||Standard Deviation|Mean
774992|NCT00753454|Secondary|Percentage of Subjects With SDAI (Simplified Disease Activity Index) Remission (SDAI ≤3.3) at Completion/Withdrawal Visit|"SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm), and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI).
<= 3.3 (Remission), > 3.3 - <= 11 Low, > 11 - <= 26 Moderate, > 26 High."|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 151 are included in this analysis.
Data was not available for 17 subjects."||percentage of subjects|||Number
774993|NCT00753454|Secondary|Percentage of Subjects With DAS28[ESR] (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Remission (DAS28[ESR] < 2.6) at Completion/Withdrawal Visit|"DAS28(ESR) is calculated using the tender joint count (TJC), swollen joint count (SJC) erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI).
< 2.6 (Remission),
> = 2.6 - < =3.2 Low, > 3.2 - < = 5.1 Moderate, > 5.1 High."|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 149 are included in this analysis.
Data was not available for 19 subjects."||percentage of subjects|||Number
774994|NCT00753454|Secondary|Change From Baseline in CDAI (Clinical Disease Activity Index) at Completion/Withdrawal Visit|"CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm), and Investigator’s Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
The range for the CDAI is 0 - 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity."|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 146 are included in this analysis.
Data was not available for 22 subjects."||units on a scale||Standard Deviation|Mean
774995|NCT00753454|Secondary|Change From Baseline in SDAI (Simplified Disease Activity Index) at Completion/Withdrawal Visit|"SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm), and Investigator’s Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
<= 3.3 Remission, > 3.3 - <= 11 Low, > 11 - <= 26 Moderate, > 26 High."|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 145 are included in this analysis.
Data was not available for 23 subjects."||units on a scale||Standard Deviation|Mean
774996|NCT00753454|Secondary|Change From Baseline in DAS28[ESR] (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) at Completion/Withdrawal Visit|"DAS28(ESR) is calculated using the tender joint count (TJC), swollen joint count (SJC) erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
< 2.6 Remission,
> = 2.6 - < =3.2 Low, > 3.2 - < = 5.1 Moderate, > 5.1 High."|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 142 are included in this analysis.
Data was not available for 26 subjects."||units on a scale||Standard Deviation|Mean
774997|NCT00753454|Secondary|Percentage of Subjects With ACR70 (American College of Rheumatology 70% Improvement) Response at Completion/Withdrawal Visit|ACR70 response is defined for subjects with at least 70% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity, 5) Physician's Global Assessment of Disease Activity.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 155 are included in this analysis.
Data was not available for 13 subjects."||percentage of subjects|||Number
774998|NCT00753454|Secondary|Percentage of Subjects With ACR50 (American College of Rheumatology 50% Improvement) Response at Completion/Withdrawal Visit|ACR50 response is defined for subjects with at least 50% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity, 5) Physician's Global Assessment of Disease Activity.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 155 are included in this analysis.
Data was not available for 13 subjects."||percentage of subjects|||Number
774999|NCT00753454|Secondary|Percentage of Subjects With ACR20 (American College of Rheumatology 20% Improvement) Response at Completion/Withdrawal Visit|ACR20 response is defined for subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity, 5) Physician's Global Assessment of Disease Activity.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 155 are included in this analysis.
Data was not available for 13 subjects."||percentage of subjects|||Number
775168|NCT00754624|Secondary|High Resolution Computerized Tomography Scans of the Chest||End of study|participants in Safety population with available post-baseline data||participants|||Number
775217|NCT00755261|Primary|RECIST|Study was terminated because of low accrual.|6 month PFS|study was terminated because of low accrual (4 subjects enrolled/2 years)|||||
775001|NCT00753454|Primary|Percentage of Subjects Withdrawing From Study Due To A Treatment-emergent Adverse Event (TEAE) During The Study Period|"A TEAE is defined as any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any phase of a clinical trial including Pretreatment, Run-In, Wash-Out, or Follow-Up Phases.
A TEAE is defined as being independent of assumption of any causality (eg, to trial or concomitant medication, primary or concomitant disease, or trial design).
TEAEs are all AEs in which the onset date and time is after the first study drug administration in C87084, up to 84 days after the last injection."|From Entry Visit up to approximately 60 weeks|Of the 168 subjects in the Full Analysis Set (FAS), 168 are included in this analysis.||percentage of subjects|||Number
775002|NCT00753454|Primary|Percentage of Subjects Reporting At Least One Treatment-emergent Adverse Event (TEAE) During The Study Period|"A TEAE is defined as any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any phase of a clinical trial including Pretreatment, Run-In, Wash-Out, or Follow-Up Phases.
A TEAE is defined as being independent of assumption of any causality (eg, to trial or concomitant medication, primary or concomitant disease, or trial design).
TEAEs are all AEs in which the onset date and time is after the first study drug administration in C87084, up to 84 days after the last injection."|From Entry Visit up to approximately 60 weeks|Of the 168 subjects in the Full Analysis Set (FAS), 168 are included in this analysis.||percentage of subjects|||Number
775003|NCT00753506|Secondary|Change in Cognitive Functioning as Measured by the Repeatable Battery for the Assessment of Neuropsychological Status and Change in Functional Performance as Measured by the UCSD Performance-based Skills Assessment.||10 weeks (weeks 2 & 12)||||||
775004|NCT00753506|Primary|Change in Positive and Negative Syndrome Scale (PANSS) Score From the Beginning to the End of the Double-blind Treatment Phase Weeks 2-12|The Positive and Negative Syndrome Scale (PANSS) measures psychiatric symptomatology, especially related to psychosis. The complete PANSS contains ratings for 30 symptoms, including 7 positive symptoms, 7 negative symptoms, and 16 general psychiatric symptoms. The severity of each symptom is rated on a scale ranging from 1 (minimal) to 7 (extreme); higher scores indicate increased symptomatology. Total PANSS scores include scores from all categories and range from 30 to 210 units on a scale. PANSS positive symptom scores and negative symptom scores each range from 7 to 49 units on a scale.|10 weeks (weeks 2 & 12)|||units on a scale||Standard Deviation|Mean
775005|NCT00753519|Secondary|Motor UPDRS|The Motor Unified Parkinson's Disease Rating Scale (UPDRS) includes only the motor assessment of the UPDRS (Part III) and examines speech, facial expression, tremor at rest, action tremor, rigidity, finger taps, hand movements, hand pronation and supination, leg agility, arising from chair, posture, gait, postural stability and body bradykinesia. The scores range from 0 (no motor impairment) to 108 (severe motor impairment).|baseline, 1 day post iTBS|||units on a scale||Standard Deviation|Mean
775006|NCT00753519|Secondary|Total UPDRS Score|The Total Unified Parkinson's Disease Rating Scale (UPDRS) is an overall assessment scale that quantifies the signs and symptoms of Parkinson's disease. The total UPDRS score consists of mentation, behavior, mood, activities of daily living and motor components, and ranges from 0 (not affected) to 176 (most severely affected). The total UPDRS score is obtained from patient examination, interview and patient questionnaires.|baseline, 1 day post iTBS|||units on a scale||Standard Deviation|Mean
775007|NCT00753519|Secondary|Bradykinesia|Bradykinesia refers to the slowness in executing a movement. Bradykinesia was assessed by measuring the time in seconds it takes to do the following sequence, 10 times: 1) hand closing and opening while squeezing a ball 2) elbow flexion 3) hand closing and opening, and 4) elbow extension. Subjects were allowed to practice these hand and arm movements until performance appeared not to get faster, and then were abstained from further practice to minimize learning effects. The time it takes subjects to execute the entire sequence 10 times with either the left or right arm/hand was measured. Means are reported for each group.|baseline, 1 day post iTBS|||seconds||Standard Deviation|Mean
775008|NCT00753519|Primary|Gait Speed|Gait speed was assessed by measuring the time it takes to walk 10 meters. Subject's gait speed was measured while on medication and off medication for each group, i.e., real iTBS and sham iTBS. Two trials were averaged for each condition. Patients were instructed to walk fast without taking the risk of falling, wearing the same shoes and consistently using assistive devices if needed. Gait speed was measured at baseline, 1 day post intervention, and 1 month post intervention.|baseline, 1 day post iTBS|||seconds||Standard Deviation|Mean
775009|NCT00753545|Secondary|Functional Analysis of Cancer Therapy - Ovarian (FACT-O) Time to Worsening|The time to worsening was compared between treatments for each of the TOI, FOSI and total FACT-O. [Evaluable for FACT-O set]|Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.|||Months||95% Confidence Interval|Median
775010|NCT00753545|Secondary|Trial Outcome Index(TOI)Time to Worsening|The time to worsening was compared between treatments for each of the TOI, FOSI and total FACT-O. [Evaluable for TOI set]|Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.|||Months||95% Confidence Interval|Median
775011|NCT00753545|Secondary|FACT-O Symptom Index (FOSI) Time to Worsening|The time to worsening was compared between treatments for each of the TOI, FOSI and total FACT-O. [Evaluable for FOSI set]|Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.|||Months||95% Confidence Interval|Median
775012|NCT00753545|Secondary|Improvement Rate for Total Functional Analysis of Cancer Therapy - Ovarian (FACT-O)|The percentage of patients with an improvement in total FACT-O. Improvement was defined as a change from baseline of greater than or equal to +9. [Evaluable for FACT-O set]|Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.|Evaluable for Total Fact-O set - A subset of the full analysis set which includes patients who have evaluable QoL/Symptom Endpoints at baseline||percentage of evaluable participants|||Number
775013|NCT00753545|Secondary|Improvement Rate for Trial Outcome Index (TOI)|The percentage of patients with an improvement in TOI. Improvement was defined as a change from baseline of greater than or equal to +7. [Evaluable for TOI set]|Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.|Evaluable for TOI - a subset of the full analysis set which includes patients who have evaluable QoL/Symptom Endpoints at baseline||percentage of evaluable participants|||Number
775014|NCT00753545|Secondary|Improvement Rate for FACT-O Symptom Index (FOSI)|The percentage of patients with an improvement in FOSI. Improvement was defined as a change from baseline of greater than or equal to +3. [Evaluable for FOSI set]|Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.|Evaluable for FOSI set - A subset of the full analysis set which includes patients who have evaluable QoL/Symptom Endpoints at baseline||percentage of evaluable participants|||Number
775015|NCT00753545|Secondary|Time to Earlier of CA-125 or RECIST Progression|Time from randomisation to the earlier date of radiological progression (per RECIST criteria) or CA-125 or death by any cause in the absence of objective progression. [FAS]|Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/- 1 week) thereafter and monthly for CA-125 measurements, assessed maximum up to 14 months.|||Months||95% Confidence Interval|Median
775016|NCT00753545|Secondary|RECIST and CA-125 Response Separately and Combined|RECIST and CA-125 response separately and combined [Patients evaluable for either CA-125 response or RECIST response]|Radiologic scans performed at baseline then every 12 weeks (+/- 1week) for the first 60 weeks, then every 24 weeks (+/- 1 week) thereafter and monthly for CA-125 measurements, assessed maximum up to 14 months.|||Participants|||Number
775017|NCT00753545|Secondary|Best Objective Response|Best overall response from radiologic assessments. [FAS]|Radiologic scans performed at baseline then every 12 weeks (+/- 1week) for the first 60 weeks, then every 24 weeks (+/- 1 week) thereafter, assessed maximum up to 14 months.|||Participants|||Number
775018|NCT00753545|Secondary|Best Percentage Change in Cancer Antigen 125 (CA-125) Levels|Best percentage change from baseline in CA-125 level|CA-125 was measured at baseline then every 28 days on treatment, assessed maximum up to 14 months.|A subset of the FAS with baseline and at least 1 follow-up value of CA-125||percentage of change||Full Range|Median
775019|NCT00753545|Secondary|Percentage Change From Baseline in Tumour Size at Week 24|Percentage change from baseline to Week 24 in target tumour size.|Radiologic scans performed at baseline then every 12 weeks (+/- 1week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months.|Evaluable for response set - A subset of the full analysis set which includes patients with measurable disease at baseline.||Percent change in tumour size||Full Range|Least Squares Mean
775020|NCT00753545|Secondary|Duration of Response|Duration of response = time from assessment prior to timepoint where PR or CR confirmed (i.e. initial assessment of PR/CR), until earliest date of objective progression or death. [Responding patients only]. There were insufficient responses to enable conclusions to be drawn.|Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months.|||Months||95% Confidence Interval|Median
775021|NCT00753545|Secondary|Disease Control Rate|Disease control rate was defined as the percentage of patients who have at least 1 confirmed visit response of CR or PR or have demonstrated SD or NED for at least 23 weeks (ie, 24 weeks +/- 1 week) prior to any evidence of progression. [FAS]|Assessed at 24 weeks. Radiologic scans performed at baseline, week 12 (+/- 1 week) and week 24 (+/- 1 week).|||percentage of participants|||Number
775022|NCT00753545|Secondary|Objective Response Rate (ORR) (According to RECIST)|For each treatment group, the ORR was the number of Complete Response (CR) and Partial Response (PR) divided by the number of patients in the group in the FAS with measurable disease at baseline (displayed as a percentage below). Evaluable for response set|Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months.|Evaluable for response set - A subset of the full analysis set which includes patients with measurable disease at baseline||percentage of participants|||Number
775023|NCT00753545|Secondary|Overall Survival (OS)|OS = time from randomisation to date of death from any cause. Patients who had not died at time of analysis were censored at last date patient was known to be alive.|Follow up every 12 weeks post progression, assessed maximum up to 90 months.|||Months||95% Confidence Interval|Median
775024|NCT00753545|Primary|Progression Free Survival (PFS) (According to Response Evaluation Criteria in Solid Tumours [RECIST])|PFS was defined as the time from randomisation to the earlier date of radiological progression (per RECIST criteria) or death by any cause in the absence of objective progression. [Full analysis set (FAS)]|Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months.|||Months||95% Confidence Interval|Median
775025|NCT00753623|Primary|Difference in Visual Analog Scale (VAS) for Pain (0-10) Between Treatments|Subjects were asked to rate their pain the VAS with 0 being no pain and 10 being the worst pain they can imagine. The VAS scores were compared between the baseline and after a period of treatment. A negative number indicates an improvement in pain from baseline score.|VAS score at baseline and after the treatment period|Only 15 subjects completed both treatment phases so we only included these subjects in the analysis.||units on a scale||Standard Deviation|Mean
775026|NCT00753636|Secondary|Pharmacokinetic Data – Mean Serum Concentration and Dosage Exposure Across the Dose Range of Isradipine|Mean Plasma Concentration (+/- SD ng/mL)|1 year|||ng/mL||Standard Deviation|Mean
775027|NCT00753636|Secondary|Change in Motor UPDRS Scores: Baseline vs. Final Visit|"Baseline visit = Week 0 Final visit = Week 12
Unified Parkinson's Disease Rating Scale (UPDRS)is made up of the following sections:
Part I: evaluation of Mentation, behavior, and mood Part II: self evaluation of the activities of daily life Part III: clinician-scored motor evaluation Part IV: Hoehn and Yahr stating of severity of Parkinson disease. Part V: Schwab and England ADL scale Only part three was used for this assessment.
The higher the UPDRS score, the greater the disability from PD.
The range for scores for Section III is 0 to 108."|12 weeks|||UPDRS Part III Score||Standard Deviation|Mean
775028|NCT00753636|Secondary|Number of Participants That Completed the Study at Each Dose Level of Isradipine||1 year|||Participants|||Number
775029|NCT00753636|Secondary|Number of Participants That Tolerated Each Dose Level of Isradipine Between PD Patients Treated With Antihypertensive Agent and Not on Antihypertensive Agent|"At the time of enrollment, some patients were currently being treated with antihypertensive agents including Propanolol, Toprol, Lisinopril, Diovan, Norvasc.
HTN+: Participants on an antihypertensive agent HTN-: Participants not on an antihypertensive agent"|1 year|||Participants|||Number
775030|NCT00753636|Secondary|Number of Participants That Tolerated Each Dose of Isradipine|Tolerability= maximum tolerated dose|1 year|||Participants|||Number
775033|NCT00753649|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period up to Last subject last visit on 03/12/2013|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one dose of Infanrix hexa administration documented.||Subjects|||Number
775034|NCT00753649|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31 day (Days 0-30) post vaccination|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one dose of Infanrix hexa administration documented.||Subjects|||Number
775035|NCT00753649|Secondary|Anti-HBs Antibody Concentrations|Anti-HBs antibody concentrations were assessed by Enzyme-Linked Immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs).|One month after (POST) Dose 3.|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received 3 doses of Infanrix Hexa vaccine and for whom data concerning immunogenicity outcome measures were available.||mIU/mL||95% Confidence Interval|Geometric Mean
775036|NCT00753649|Secondary|Number of Subjects With Anti-HBs Antibody Concentrations ≥100 mIU/mL|The testing was done using the Enzyme-Linked Immunosorbent assay (ELISA) assay.|One month after (POST) Dose 3.|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received 3 doses of Infanrix Hexa vaccine and for whom data concerning immunogenicity outcome measures were available.||Subjects|||Number
775037|NCT00753649|Secondary|Number of Seroprotected Subjects Against Hepatitis B (Anti-HBs)|A seroprotected subject was a subject with anti-HBs antibody concentrations ≥ 10 milli-International Units ler milliliter (mIU/mL). A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis. Some of the available blood samples initially tested with ELISA were re-tested using the new assay, CLIA.|One month after (POST) Dose 3.|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received 3 doses of Infanrix Hexa vaccine and for whom data concerning immunogenicity outcome measures were available.||Subjects|||Number
775038|NCT00753649|Secondary|Anti-PRP Antibody Concentrations|Anti-PRP antibody concentrations were presented as Geometric mean Concentrations (GMC), expressed as micrograms per milliliter (μg/mL).|One month after (POST) Dose 3.|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received 3 doses of Infanrix Hexa vaccine and for whom data concerning immunogenicity outcome measures were available.||µg/mL||95% Confidence Interval|Geometric Mean
775039|NCT00753649|Secondary|Number of Subjects With Anti-PRP Antibody Concentrations ≥1µg/mL|For this assay, 1 μg/mL was considered as the seropositivity cut-off.|One month after (POST) Dose 3.|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received 3 doses of Infanrix Hexa vaccine and for whom data concerning immunogenicity outcome measures were available.||Subjects|||Number
775040|NCT00753649|Primary|Number of Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (Anti-PRP)|A seroprotected subject was a subject whose anti-PRP antibody concentration was greater or equal to (≥) 0.15 microgram per milliliter (µg/mL).|One month after (POST) Dose 3.|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received 3 doses of Infanrix Hexa vaccine and for whom data concerning immunogenicity outcome measures were available.||Subjects|||Number
775041|NCT00753675|Secondary|Overall Survival|OS is defined from the date of randomization to death|up to 1032 days|ITT||Days||95% Confidence Interval|Median
775042|NCT00753675|Secondary|Duration of Response (DOR)|DOR is defined from the date of first documentation of response until date of PD or death|up to 1032 days|ITT (best response of CR or PR only)||Days||95% Confidence Interval|Median
775043|NCT00753675|Secondary|Disease Control Rate (CR+PR+SD)|DCR is the sum of patients with a best overall CR, PR or SD (>=8 weeks) by the patient in the analysis|up to 1032 days|ITT||Partecipants|||Number
775044|NCT00753675|Secondary|Objective Tumor Response Rate (CR+PR),|Objective Tumor Response Rate was defined as complete response (CR) + partial response (PR) evaluated by RECIST. CR was defined as disappearance of all target lesions. PR was defined as at least 30% decrease in the sum of longest diameters (LD) of target lesion(s) taking as reference the baseline sum of LD|up to 1032 days|ITT||Participants|||Number
775045|NCT00753675|Primary|Progression Free Survival|Progression was defined as Time from the date of first dose of study medication to progression of disease, or death (it also includes patients who are lost to follow-up or have withdrawn consent) and evaluated with RECIST criteria as an increase of at least 20% in the sum of longest diameter (LD) of target lesion(s) taking as reference the smallest sum of LD since the treatment started or any new lesion(s).|up to 1032 days|ITT||days||95% Confidence Interval|Median
775046|NCT00753688|Secondary|Number of Participants With the Indicated Absolute Percent Change From Baseline (BL) in Left Ventricular Ejection Fraction (LVEF) at Any Time Post-BL (Worst Case On-therapy)|LVEF is the measurement of how much blood is being pumped out of the left ventricle of the heart (the main pumping chamber) with each contraction and is used to determine cardiac function (based on the institutional lower limit of normal [LLN]). LVEF was assessed at BL, Week 12, and every second scheduled visit thereafter until study drug discontinuation and end of treatment or as clinically indicated by using multi-gated acquisition scan (MUGA) or echocardiogram (ECHO). Absolute change from BL was calculated as the on-study value minus the baseline value (LVEF is calculated as a percentage).|Baseline (within 14 days of the first dose of study drug) and any time post-baseline until study drug discontinuation or end of treatment (assessed for an average of 20 weeks)|Safety Population. Data were analyzed for participants who were on-therapy and provided data at the indicated time point.||participants|||Number
775169|NCT00754624|Secondary|Change in Weight in kg From Baseline to End of Study|Baseline to last measurement on study drug (maximum of 48 months)|Baseline to last measurement on study drug (maximum of 48 months)|Safety||kilograms||Standard Deviation|Mean
775047|NCT00753688|Secondary|Number of Participants With the Indicated Grade Shifts From Baseline Grade for Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Albumin, Creatinine, Hyper/Hypoglycemia, Hyper/Hypokalemia, Hyper/Hyponatremia, and Total Bilirubin|Shifts in clinical chemistry values by grade were summarized based on the NCI CTCAE Version 3.0. Participants with a missing baseline grade were assumed to have a baseline Grade of 0. Any increase in grade from baseline and shifts to Grade 3 and 4 at any point in the study after baseline are reported. alkaline phosphatase, ALKP; alanine aminotransferase, ALT; aspartate aminotransferase, AST. Hyper/hypoglycemia refers to high/low glucose; hyper/hypokalemia refers to high/low potassium; hyper/hyponatremia refers to high/low sodium.|From baseline (Day 1) until study drug discontinuation or end of treatment (assessed for an average of 20 weeks)|Safety Population. Data were analyzed for participants who were on-therapy and provided data at the indicated time point.||participants|||Number
775048|NCT00753688|Secondary|Number of Participants With the Indicated Grade Shifts From Baseline Grade for Hemoglobin Level, Lymphocyte Count, White Blood Cell Count, Neutrophil Count, and Platelet Count|Shifts in hematology values by grade were summarized based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE Version 3.0). Grade refers to the severity of the AE. The CTCAE Version 3.0 displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline. Participants with a missing baseline grade were assumed to have a baseline Grade of 0. Any increase in grade from baseline and shifts to Grade 3 (severe AE) and 4 (life-threatening or disabling AE) at any point in the study after baseline are reported.|From baseline (Day 1) until study drug discontinuation or end of treatment (assessed for an average of 20 weeks)|Safety Population. Data were analyzed for participants who were on-therapy and provided data at the indicated time point.||participants|||Number
775049|NCT00753688|Secondary|Change From Baseline in Heart Rate|Change from baseline in on-therapy heart rate was calculated as the value at the indicated time points (Day 8 and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 88, 96, and 104) minus the value at baseline.|Baseline, Day 8, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 88, 96, and 104|Safety Population. Data were analyzed for participants who were on-therapy and provided data at the indicated time point.||beats per minute||Standard Deviation|Mean
775050|NCT00753688|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Change from baseline in on-therapy SBP and DBP was calculated as the values at the indicated time points (Day 8 and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 88, 96, and 104) minus the value at baseline.|Baseline, Day 8, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 88, 96, and 104|Safety Population: all participants who had started their allocated treatment (at least one dose of the study drug). Data were analyzed for participants who were on-therapy and provided data at the indicated time point.||Millimeters of mercury||Standard Deviation|Mean
775051|NCT00753688|Secondary|PFS in the Indicated Histology Subgroups of Soft Tissue Sarcoma (STS)|PFS was defined as the time interval between the date of randomization and the earliest date of either disease progression or death due to any cause. Participants were analyzed for PFS in histology subgroups of STS (as per the World Health Organization [WHO] classification, 2008): leiomyosarcoma (malignant cancer of smooth muscle), synovial sarcoma (cancer near the joints of the arm or leg), and other STS (without the tumor type of leiomyosarcoma or synovial sarcoma), based on independent review.The Kaplan-Meier method was used for PFS estimates.|From the date of randomization until the date of the first documented progression or the date of death from any cause, whichever came first (assessed for an average of 10 months)|"ITT Population. The ns in the category titles represent the number of participants in each treatment arm with the indicated STS."||weeks||95% Confidence Interval|Median
775052|NCT00753688|Secondary|Duration of Response Assessed by the Independent Radiologist and the Investigator|Duration of response was defined as the time from the date of the first documented evidence of CR or PR until the date of either the first documented sign of PD or death due to any cause. Participants who neither died nor progressed were censored at the date of the last adequate radiologic assessment. The Kaplan-Meier method was used for duration of response estimates.|From the date of randomization until the date of the first documented evidence of CR or PR (assessed for an average of 10 months)|ITT Population. Only participants who achieved a confirmed CR or PR, as determined independently by the Independent Radiologist and the Investigator, were analyzed. Only results for the pazopanib arm are given because there was no response in the placebo arm.||weeks||95% Confidence Interval|Median
775053|NCT00753688|Secondary|Time to Response Assessed by an Independent Radiologist and the Investigator|Time to response was defined as the time from the date of randomization until the date of first documented evidence of CR or PR (whichever status was recorded first). The Kaplan-Meier method was used for time to response estimates.|From the date of randomization until the date of the first documented evidence of CR or PR (assessed for an average of 10 months)|ITT Population. Only participants who achieved a confirmed CR or PR, as determined independently by the Independent Radiologist and the Investigator, were analyzed. Only results for the pazopanib arm are given because there was no response in the placebo arm.||weeks||95% Confidence Interval|Median
775054|NCT00753688|Secondary|Number of Participants in the Indicated Categories for Overall Response Assessed by an Independent Radiologist and the Investigator|Overall response is defined as the number of participants who had a complete response (CR) or a partial response (PR). According to RECIST, Version 1.0: CR, disappearance of all lesions; PR, a >=30% decrease in the sum of the longest dimensions (LD) of the target lesions (TLs) taking as a reference the baseline sum LD; Progressive disease (PD), a >=20% increase in the sum of the LD of TLs, or the appearance of >=1 new lesion; Stable Disease (SD), neither PR nor PD, persistence of >=1 non-TL. Participants with no follow-up radiological disease assessment were categorized as not evaluable (NE).|From the start of treatment until disease progression (assessed for an average of 10 months)|ITT Population||participants|||Number
775055|NCT00753688|Secondary|Overall Survival (OS)|OS was defined as the time from the date of randomization to the date of death due to any cause. The length of this interval was calculated as the date of death minus the date of randomization plus 1 day. Participants who were alive at the time of analysis were censored at the date of last follow-up. The interim OS analysis was conducted when 215 (77 percent [%]) of the 279 required death events had occurred in the study. The Kaplan-Meier method was used for OS estimates.|From the date of randomization until 215 deaths (assessed for an average of 12 months)|ITT Population||months||95% Confidence Interval|Median
775056|NCT00753688|Primary|Progression-free Survival (PFS)|PFS was defined as the time interval between the date of randomization and the earliest date of either disease progression or death due to any cause. The diagnosis of progression was based on tumor measurements, according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 criteria, by independent radiologic assessment. The Kaplan-Meier method was used for PFS estimates.|From the date of randomization until the date of the first documented radiological progression or date of death from any cause, whichever came first (assessed for an average of 10 months)|Intent-to-Treat (ITT) Population: all randomized participants analyzed in the treatment arm they were allocated by randomization.||weeks||95% Confidence Interval|Median
775057|NCT00753714|Secondary|The Safety and Tolerability Profile of ZD6474 (Vandetanib) in Combination With Gemcitabine|The Safety and Tolerability Profile of ZD6474 (Vandetanib) in Combination With Gemcitabine is defined as the number of Adverse Events which includes any symptoms and/or Clinically Significant Laboratory or Vital Signs Abnormalities, and/or ECGs Changes|Oct 2008- Dec 2011|||Adverse Events|||Number
775058|NCT00753714|Secondary|Duration of Response||Oct 2008- dec 2011|||days||95% Confidence Interval|Median
775059|NCT00753714|Secondary|Overall Objective Response||Oct 2008- dec 2011|||Participants|||Number
775060|NCT00753714|Secondary|Overall Survival||Oct 2008- dec 2011|||days||95% Confidence Interval|Median
775061|NCT00753714|Primary|Progression Free Survival||Oct 2008- dec 2011|||days||95% Confidence Interval|Median
775062|NCT00753766|Secondary|Rate of Return to the Operating Room||6 weeks||||||
775063|NCT00753766|Secondary|A Composite of Death From Cardiovascular Cause, Non-fatal Myocardial Infarction, Coronary Artery Bypass Grafting, Percutaneous Coronary Intervention, Nonfatal Stroke, or Amputation as a Result of Peripheral Ischemia||6 weeks||||||
775064|NCT00753766|Secondary|Length of Hospital Stay||6 weeks||||||
775065|NCT00753766|Secondary|Occurrence of Wound Infection in the 30 Day Post-operative Period||6 weeks||||||
775066|NCT00753766|Secondary|Change in A1c & Fructosamine From Baseline to Pre-admission (A1c is the Standard Parameter to Assess Chronic Glucose Control, Fructosamine Provides a Measure of Shorter-term Glucose Control [2-3 Wks])||6 weeks||||||
775067|NCT00753766|Secondary|Percent of Participants Not Completing the Protocol Due to the Need for Urgent Surgery and/or Treatment-related Complications||6 weeks|||participants|||Number
775068|NCT00753766|Secondary|Participant Adherence With the Study Protocol (i.e. Attending Study Visits, CGMS Studies||6 weeks||||||
775069|NCT00753766|Primary|Percent of Screened Participants That Are Eligible and Choose Participation||6 weeks|||percentage of potential participants|||Number
775070|NCT00753896|Secondary|Change in Blood Pressure From Baseline to Week 52|Change in Systolic and Diastolic Blood Pressure from baseline to endpoint|Baseline, Week 52|All enrolled patients who had taken at least one dose of study drug. Last observation carried forward. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.||mmHg||Standard Error|Mean
775071|NCT00753896|Secondary|Change in Triglycerides From Baseline to Week 52|Change in Triglycerides from baseline to endpoint|Baseline, Week 52|All enrolled patients who had taken at least one dose of study drug. Last observation carried forward. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.||mmol/L||Standard Error|Mean
775072|NCT00753896|Secondary|Change in High-density Lipoprotein (HDL) From Baseline to Week 52|Change in HDL from baseline to endpoint|Baseline, Week 52|All enrolled patients who had taken at least one dose of study drug. Last observation carried forward. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.||mmol/L||Standard Error|Mean
775073|NCT00753896|Secondary|Change in Total Cholesterol From Baseline to Week 52|Change in Total Cholesterol from baseline to endpoint|Baseline, Week 52|All enrolled patients who had taken at least one dose of study drug. Last observation carried forward. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.||mmol/L||Standard Error|Mean
775074|NCT00753896|Secondary|Change in Body Weight From Baseline to Week 52|Change in body weight from baseline to endpoint|Baseline, Week 52|All enrolled patients who had taken at least one dose of study drug. Last observation carried forward. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.||kg||Standard Error|Mean
775075|NCT00753896|Secondary|Change in Fasting Serum Glucose From Baseline to Week 52|Change in fasting serum glucose from baseline to endpoint|Baseline, Week 52|All enrolled patients who had taken at least one dose of study drug. Last observation carried forward. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.||mmol/L||Standard Error|Mean
775076|NCT00753896|Secondary|Percentage of Patients Achieving HbA1c <=6.5% at Week 52|Percentage of patients achieving HbA1c <=6.5% at endpoint (for patients with HbA1c >6.5% at baseline)|Baseline, Week 52|All enrolled patients who had taken at least one dose of study drug and whose baseline HbA1c was > 6.5%. Last observation carried forward. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.||percentage of patients|||Number
775077|NCT00753896|Secondary|Percentage of Patients Achieving HbA1c <=7% at Week 52|Percentage of patients achieving HbA1c <=7% at endpoint (for patients with HbA1c >7% at baseline)|Baseline, Week 52|All enrolled patients who had taken at least one dose of study drug and whose baseline HbA1c was > 7% . Last observation carried forward. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.||percentage of patients|||Number
775078|NCT00753896|Secondary|Change in HbA1c From Baseline to Week 52|Change in HbA1c from baseline to endpoint|Baseline, Week 52|All enrolled patients who had taken at least one dose of study drug. Last observation carried forward. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.||percentage of total hemoglobin||Standard Error|Mean
775170|NCT00754624|Secondary|Change in FPG From Baseline to Last Study Measurement on Treatment (Maximum of 48 Months)|Change from Baseline to last study measurement on treatment (maximum of 48 months)|Baseline to last study measurement on treatment (maximum of 48 months)|||milligrams per deciliter||Standard Deviation|Mean
775079|NCT00753896|Primary|Assessment of Event Rate of Treatment-Emergent Hypoglycemic Events|Major hypoglycemia: any episode with symptoms consistent with hypoglycemia that resulted in loss of consciousness or seizure with prompt recovery in response to administration of glucagon or glucose OR documented hypoglycemia (blood glucose <3.0 mmol/L [54 mg/dL]) and required the assistance of another person. Minor hypoglycemia: any sign or symptom associated with hypoglycemia that is either self-treated by the patient or resolves on its own AND has a concurrent finger stick blood glucose <3.0 mmol/L (54 mg/dL) and not classified as major hypoglycemia. Mean event rate = total number of events for all subjects in a treatment regimen / the total number of subject years of exposure for all subjects in that treatment. Standard error = square root of (total number of events / (subject years of exposure)**2).|Baseline to Week 52|All enrolled patients who had taken at least one dose of study drug. Sample size based on FDA recommendation for safety exposure: a minimum of 100 patients completing at least 52 weeks of treatment is sought to assess long-term safety associated with exposure to exenatide once weekly.||events per subject-year||Standard Error|Mean
775080|NCT00753896|Primary|Percentage of Patients Experiencing Adverse Events|Percentage of patients experiencing treatment-emergent adverse events over 52 weeks|Baseline to Week 52|All enrolled patients who had taken at least one dose of study drug. Sample size based on FDA recommendation for safety exposure: a minimum of 100 patients completing at least 52 weeks of treatment is sought to assess long-term safety associated with exposure to exenatide once weekly.||percentage of patients|||Number
775081|NCT00753922|Post-Hoc|10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Complications|The safety analyses were conducted in accordance with the FDA November 17, 2006 “Guidance for Industry and FDA Staff – Saline, Silicone Gel, and Alternative Breast Implants.” The study investigator assessed any complications durign study follow-up visits in alignment with this guidance. Time of occurrence was calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest. Complications with an incidence > 5.0% are reported.|10 years|All Enrolled Subjects||percentage of subjects||95% Confidence Interval|Number
775082|NCT00753922|Primary|10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Explantation With or Without Replacement|Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest.|10 Years|All enrolled subjects||percentage of subjects||95% Confidence Interval|Number
775083|NCT00753922|Primary|10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Infection|Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest.|10 Years|All enrolled subjects||percentage of subjects||95% Confidence Interval|Number
775084|NCT00753922|Primary|10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Baker III, IV Capsular Contracture|"Baker III was identified as firm with visible distortion and Baker IV was identified as obvious spherical distortion. Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest."|10 Years|All enrolled subjects||percentage of subjects||95% Confidence Interval|Number
775085|NCT00753922|Primary|Overall Mean Change in Circumferential Chest Size|Change in Chest Size was calculated by subtracting the chest circumference prior to surgery from the chest circumference measured at the end of the study|Change from baseline to 10 years post-baseline|All enrolled subjects||centimeters||Standard Deviation|Mean
775086|NCT00753922|Primary|10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Any Reoperation|Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest.|10 years|All enrolled subjects are included||percentage of subjects||95% Confidence Interval|Number
775087|NCT00754234|Primary|Nonheme Iron Absorption|Absorption was estimated from whole body retention of a Iron-59 radiotracer, 2 weeks after consuming a menu labeled with the isotope, then normalized to a ferritin of 15 nanogram/milliLiter (ng/mL)|2 weeks (wks)|Analysis was per protocol||percentage of nonheme Iron absorbed||Standard Deviation|Log Mean
775088|NCT00754325|Secondary|Number of Participants With Serious Adverse Events, Death, and Discontinuation Due to Adverse Events|Adverse event (AE) defined: any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Serious adverse event (SAE) defined: a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years)|Safety Population on initial treatment; any participants that was randomized to any treatment group in the study and received at least one treatment therapy.||participants|||Number
775089|NCT00754325|Secondary|Number of Participants With Best Overall Response|Best overall response rate (ORR) = number of participants with measurable lesions by Response Evaluation Criteria in Solid Tumors (RECIST) having a best response of complete response (CR) or partial response (PR) divided by number of randomized participants. RECIST 1.1 response criteria applies. To be recorded as best response, CR or PR had to be confirmed at ≥ 4 weeks interval. An unconfirmed CR was recorded as PR.|Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years)|Evaluable population on initial treatment with measurable lesion by RECIST (Response Evaluation Criteria In Solid Tumors). Participants without tumor response assessment due to rapid progression or study drug toxicity included in population as non-responders.||participants|||Number
775171|NCT00754624|Secondary|Change in HbA1c From Baseline to Last Measurement on Study Drug (Maximum of 48 Months)|Change in HbA1c from Baseline to last measurement on study drug (maximum of 48 months)|Baseline to last measurement on study drug (maximum of 48 months|Safety||percentage||Standard Deviation|Mean
775090|NCT00754325|Secondary|Number of Participants With Complete Response (CR) , Partial Response (PR), Stable Disease (SD), and Disease Progression (PD)|Table represents the best response achieved over this time frame. CR = Disappearance of all target lesions. No new lesions. PR = At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. SD = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference the smallest sum LD since the treatment started. Progression (PD): At least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years)|Evaluable population on initial treatment; all treated participants with measurable disease at baseline and at least one on-study tumor assessment. Participants without tumor response assessment due to rapid progression or study drug toxicity included in population as non-responders.||participants|||Number
775091|NCT00754325|Secondary|Percentage of Participants With Clinical Benefit for At Least 6 Months|Clinical benefit rate (CBR) was defined as the percentage of participants that had Stable Disease (SD), complete response (CR), or partial response (PR) for greater than or equal to 6 months if there was no evidence of progression at or before assessment performed on or after Study Day 161. CR= Disappearance of all target lesions. No new lesions. PR= At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. SD= Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference the smallest sum LD since the treatment started. Physical examination, radiological assessment, and bone scans (if applicable) were used to assess outcome.|Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years)|Evaluable population on initial treatment; all treated participants with measurable disease at baseline and at least one on-study tumor assessment. Participants without tumor response assessment due to rapid progression or study drug toxicity included in population as non-responders.||percentage of participants||95% Confidence Interval|Number
775092|NCT00754325|Secondary|Percentage of Participants With Progression Free Survival (PFS) at 6 Months|PFS rate was defined as the percentage of participants experiencing no disease progression or death from any cause at 6 months after randomization. Progression free survival (PFS) was defined as the time from randomization to either the date the subject was first recorded as having PD (even if the subject went off treatment because of toxicity), or the date of death if the subject died due to any causes before progression. Progression=At least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Kaplan Meier assessments were used to estimate the percentages.|at 6 months|Evaluable population on initial treatment; all treated participants with measurable disease at baseline and at least one on-study tumor assessment. Participants without tumor response assessment due to rapid progression or study drug toxicity included in population as non-responders.||percentage of participants||95% Confidence Interval|Number
775093|NCT00754325|Secondary|Median Time of Progression-free Survival (PFS)|Progression free survival (PFS) was defined as the time in months from randomization to either the date the subject was first recorded as having PD (even if the subject went off treatment because of toxicity), or the date of death if the subject died due to any causes before progression. Progression=At least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years)|Evaluable population on initial treatment; all treated participants with measurable disease at baseline and at least one on-study tumor assessment. Participants without tumor response assessment due to rapid progression or study drug toxicity included in population as non-responders.||months||95% Confidence Interval|Median
775094|NCT00754325|Primary|Number of Participants With Disease Progression (PD) or Death|This endpoint evaluated the progression free survival (PFS) of participants amongst the total evaluable population. Progression free survival (PFS) was defined as the time from randomization to either the date the subject was first recorded as having PD (even if the subject went off treatment because of toxicity), or the date of death if the subject died due to any causes before progression. Participants with no recorded post-baseline tumor assessment had PFS censored at the day of randomization. Participants lost to follow-up were censored at the last date of contact. Participants that had not progressed or died had PFS censored at the date of last follow-up.|Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years)|Evaluable population on initial treatment; all treated participants with measurable disease at baseline and at least one on-study tumor assessment. Participants without tumor response assessment due to rapid progression or study drug toxicity included as non-responders. Censored participants = 15 Fulvestrant and Dasatinib, 9 Fulvestrant||participants|||Number
775095|NCT00754338|Primary|Lens Deposits|Subjective grading of contact lens surface deposits by investigator (0=no deposits; 4=severe deposits).|4 weeks|analysis was per protocol||Units on a scale||Standard Deviation|Mean
775096|NCT00754338|Primary|Lens Wettability|Subjective grading of contact lens surface wettability by investigator (0=excellent; 4=severely reduced).|4 weeks|analysis was per protocol||Units on a scale||Standard Deviation|Mean
775097|NCT00754338|Secondary|Corneal Staining|"Grading based on Type (0=None; 100=patch)and extent of staining (0=None; 100= Entire corneal region). Final value is Type multiplied by Extent.
Corneal staining is a test that uses an orange dye (fluorescein) and a blue light to detect damage to the cornea (front surface of eye) from minor abrasions.
A strip of blotting paper containing the dye was touched to the eyelid margin. Upon blinking, the dye spreads and coats the front surface of the eye along with the tear film covering the surface of the cornea. The investigator then rated the size, location and shape of the staining."|4 weeks|analysis was per protocol||Units on a scale||Standard Deviation|Mean
775098|NCT00754338|Secondary|Subjective Vision|Subjective vision ratings on analog scale (0= poor vision; 100= excellent vision), self report by subject based on single criterion 'vision'.|4 weeks|analysis was per protocol||Units on a scale||Standard Deviation|Mean
775099|NCT00754338|Secondary|Dryness|Subjective dryness ratings on analog scale (0= very dry; 100= not dry at all), self report by subject based on single criterion 'dryness'.|4 weeks|analysis was per protocol||Units on a Scale||Standard Deviation|Mean
775101|NCT00754377|Secondary|Change in Knowledge Scores About Quality Improvement|Residents' knowledge was assessed using the knowledge scale (e.g., describe change concept, how a cause-effect diagram is created, elements of the improvement model) from the SQI TAT and scores could range from 0 to 54 points. Difference scores were used based on total score of the scale with larger positive values indicating more increase in knowledge.|1 Month|||units on a scale||Standard Deviation|Mean
775102|NCT00754377|Primary|Beliefs About Ability to Implement a CQI Project|Residents' belief about their ability to implement a CQI project was measured using a single efficacy item (values ranged from 1, strongly disagree, to 5, strongly agree). The item is from the Systems Quality Improvement Training and Assessment Tool. Differences (post minus pre) in this belief item were looked at with positive and higher difference values reflecting more positive change/increase in belief.|1 month|||units on a scale||Standard Deviation|Mean
775103|NCT00754390|Primary|Zinc Absorption|Retention of Zinc-65 was monitored for 28 days by whole body scintillation counting. The percentage of Zinc-65 absorbed was estimated from the y-intercept of the linear portion of a semilogarithmic retention plot of percent Zinc-65 retained versus time|16 weeks|Analysis restricted to women who completed all 4 treatment periods||Percentage of Zinc-65 absorbed||Standard Error|Mean
775104|NCT00754442|Secondary|The Number of Patients With Mutations in CYP27B1|CYP27B1 gene (the gene for 25-hydroxyvitamin D-1-alpha hydroxylase) was sequenced for all in patient group and compared with published control data|blood samples taken at baseline and sequenced over several days|All patients were sequenced and compared to published control data. Controls were not sequenced for cost reasons||participants|||Number
775105|NCT00754442|Primary|The Level of Activated Vitamin D (1,25-dihydroxyvitamin D) After Parathyroid Hormone Infusion at Baseline, 4 and 8 Hours|1,25-D was measured at baseline, 4 and 8 hours after PTH infusion|baseline, 4 and 8 hours after start of infusion|The final analysis was made on participants with glomerular filtration rate (GFR) of 70 and above since <70, 1,25-D production decreases. After study completion, it was noted that one participant in each group (patient and control) had GFR<70 so these two participants were excluded from final analysis.||pg/ml||Standard Deviation|Mean
775106|NCT00754468|Secondary|Side Effects of Subjects Receiving Cryospray Therapy.||End of Study|||side effects|||Number
775107|NCT00754468|Primary|Depth of Injury|histopathological findings analyzed to determine max depth of injury (mm)|End of Study|||millimeters|Participants|80% Confidence Interval|Mean
775108|NCT00754494|Secondary|Number of Participants Reported at Least 1 Diarrhea Side Effect During the Study|Described for each arm using frequencies.|Up to 9 weeks|||participants|||Number
775109|NCT00754494|Secondary|Number of Participants Reported at Least 1 Rash Side Effect During the Study|Described for each arm using frequencies.|Up to 9 weeks|||participants|||Number
775110|NCT00754494|Secondary|Number of Participants Reported at Least 1 Side Effect During the Study|Described for each arm using frequencies. The onset of adverse events is between randomization date and off-study date.|Up to 9 weeks|||participants|||Number
775111|NCT00754494|Secondary|Normal Mucosa OSI-420 Concentration (ng/mg)|Will be quantified in biopsy samples using appropriate descriptive statistics (means and standard deviations).|Up to day 30|Outcome measure data is reported based on the evaluable samples collected and available results.||ng/mg||Standard Deviation|Mean
775112|NCT00754494|Secondary|Normal Mucosa Erlotinib Concentration (ng/mg)|Will be quantified in biopsy samples using appropriate descriptive statistics (means and standard deviations).|Up to day 30|Outcome measure data is reported based on the evaluable samples collected and available results.||ng/mg||Standard Deviation|Mean
775113|NCT00754494|Secondary|Plasma OSI-420 Concentration (ng/mL)|Will be quantified in biopsy samples using appropriate descriptive statistics (means and standard deviations).|Up to day 30|Outcome measure data is reported based on the evaluable samples collected and available results.||ng/mL||Standard Deviation|Mean
775114|NCT00754494|Secondary|Plasma Erlotinib Concentration (ng/mL)|Will be quantified in biopsy samples using appropriate descriptive statistics (means and standard deviations).|Up to day 30|Outcome measure data is reported based on the evaluable samples collected and available results.||ng/mL||Standard Deviation|Mean
775115|NCT00754494|Secondary|ACF: Normal Mucosa pERK Ratio|Quantification will be performed by Western blot analysis. Tested using analysis of variance with subsequent pairwise comparisons using the Tukey method to adjust for multiple comparisons.|Up to day 30|ACF: pERK ratio not reported as the assay did not demonstrate signaling in ACF pERK levels|||||
775116|NCT00754494|Secondary|Change in EGF-inducible Markers - Total EGFR in ACF|Total EGFR expression levels were quantified by immunoblotting and calculated as the ratio of the total EGFR signals to reference signals. A log-transformation of total EGFR was utilized in primary analyses. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.|From baseline to post-treatment (up to 30 days)|Outcome measure data is reported based on the evaluable samples collected and available results.||expression level||95% Confidence Interval|Geometric Mean
775117|NCT00754494|Secondary|Change in EGF-inducible Markers - pEGFR in ACF|pEGFR expression levels were quantified by immunoblotting and calculated as the ratio of the pEGFR signals to reference signals. A log-transformation of pEGFR was utilized in primary analyses. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.|From baseline to post-treatment (up to 30 days)|Outcome measure data is reported based on the evaluable samples collected and available results.||expression level||95% Confidence Interval|Geometric Mean
775118|NCT00754494|Secondary|Change in EGF-inducible Markers - Total EGFR in Normal Mucosa|Total EGFR expression levels were quantified by immunoblotting and calculated as the ratio of the total EGFR signals to reference signals. A log-transformation of total EGFR was utilized in primary analyses. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.|From baseline to post-treatment (up to 30 days)|Outcome measure data is reported based on the evaluable samples collected and available results.||expression level||95% Confidence Interval|Geometric Mean
775119|NCT00754494|Secondary|Change in EGF-inducible Markers - pEGFR in Normal Mucosa|pEGFR expression levels were quantified by immunoblotting and calculated as the ratio of the pEGFR signals to reference signals. A log-transformation of pEGFR was utilized in primary analyses. The general linear model was used to estimate and compare the relative change in median pEGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.|From baseline to post-treatment (up to 30 days)|Outcome measure data is reported based on the evaluable samples collected and available results.||expression level||95% Confidence Interval|Geometric Mean
775120|NCT00754494|Primary|Change in ACF pERK Levels|Quantification will be performed by Western blot analysis. Tested using paired t-test with a two-sided significance level of 0.05.|From baseline to post-treatment (up to 30 days)|Change in ACF pERK levels not reported as the assay did not demonstrate signaling|||||
775121|NCT00754546|Secondary|Linear Regression Between Breathlessness Ratings (on 0 - 10 Borg Scale) and Time Throughout Exercise|"linear regression slope of breathlessness - time for arformoterol and for normal saline will be compared between treadmill and cycle exercise
The higher the number the worse the shortness of breath"|After one dose|||breathlessness units/min||Standard Deviation|Least Squares Mean
775122|NCT00754546|Primary|Exercise Endurance Time|Participants were asked to exercise until symptom limitation|After one dose|Number of participants determined by previous studies. Analysis was intention to treat||seconds||Standard Deviation|Mean
775123|NCT00754559|Secondary|Percentage of Participants Withdrawing From Study Treatment Because of Insufficient Therapeutic Response|Participants who withdrew from study drug due to other reasons were not taken into account.|Weeks 1, 2, 4, 8, 12, 16, 20 and 24|ITT Population; participants who withdrew from study drug due to other reaasons were not included in the analysis.||percentage of participants||95% Confidence Interval|Number
775124|NCT00754559|Secondary|Changes in Erythrocyte Sedimentation Rate (ESR)|ESR is an inflammation marker used to determine acute phase response.|Baseline, Weeks 1, 2, 4 and 24|ITT Population.||mm/h||Standard Deviation|Mean
775125|NCT00754559|Secondary|Changes in C-Reactive Protein|CRP is an acute phase inflammatory marker used as a measure of inflammation. A reduction in CRP is considered to be an improvement.|Baseline, Weeks 1, 2 ,4 and 24|ITT Population||mg/L||Standard Deviation|Mean
775126|NCT00754559|Secondary|Changes in Hemoglobin|Hemoglobin levels were determined as a hematology parameter to measure changes in disease related anemia.|Baseline, Weeks 1, 2, 4 and 24|ITT Population.||g/dL||Standard Deviation|Mean
775127|NCT00754559|Secondary|Treatment Satisfaction Questionnaire for Medication (TSQM) Score|The TSQM is a general measure of participants treatment satisfaction and consists of 14 questions that result in 4 subscales: “effectiveness”, “side-effects”, “convenience” and “global satisfaction”. All subscale scores range from 0 to 100%, with 100% being the best possible result.|Week 24|ITT Population||units on a scale||Standard Deviation|Mean
775128|NCT00754559|Secondary|Participant Assessment of Fatigue/Tiredness as Assessed Using PTHF|Participants were asked to assess their overall level of fatigue/tiredness during the previous 24 hours using a 100-mm horizontal VAS with 0=none and 100=very severe. Participants responded by placing a mark on the line to indicate their current level of fatigue. Participants were asked to document their response during the first 4 treatment weeks at approximately the same time every day.|Baseline and Weeks 1, 2 and 4|ITT Population; Missing data were imputed using LOCF.||mm||Standard Deviation|Mean
775129|NCT00754559|Secondary|Duration of Morning Stiffness as Assessed Using PTHF|Duration of morning stiffness: participants were asked 'how long did your morning stiffness last from the time you woke up yesterday' and the response was provided in minutes and hours. Participants were asked to document their response during the first 4 treatment weeks at approximately the same time every day.|Baseline, Weeks 1, 2, and 4|ITT Population; Missing data were imputed using LOCF.||hours||Standard Deviation|Mean
775130|NCT00754559|Secondary|Participant's Global Assessment of Pain as Assessed by Patient Take Home Form (PTHF)|Participant's were asked to state the worst level of pain felt in the past 24 hours using a 100-mm horizontal VAS (0 to 100 mm) with 0=no pain and 100=unbearable pain. Participants responded by placing a mark on the line to indicate their level of pain. Participants were asked to document their response during the first 4 treatment weeks at approximately the same time every day.|Baseline and Weeks 1, 2, and 4|ITT Population; Missing data were imputed using LOCF.||mm||Standard Deviation|Mean
775131|NCT00754559|Secondary|Change From Baseline in Short Form-36 (SF-36) Score at Week 24|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Absolute change was defined as the change from baseline to Week 24.|Week 24|ITT Population; Missing data were imputed using LOCF.||units on a scale||Standard Deviation|Mean
775132|NCT00754559|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 24|FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the participant's health status.|Week 24|ITT Population; Missing data were imputed using LOCF.||units on a scale||Standard Deviation|Mean
775133|NCT00754559|Secondary|Change From Baseline in HAQ-DI at Week 24|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Week 24|ITT Population; Missing data were imputed using LOCF.||units on a scale||Standard Deviation|Mean
775172|NCT00754624|Secondary|Annual Rate of Change in DLCo From Baseline to End of Study||Baseline to 48 months|Safety||mL/min/mmHg per year||Standard Error|Mean
775134|NCT00754559|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) Score|"CDAI was calculated according to the following formula:
CDAI = Number of swollen joints (plus) + Number of tender joints + VAS disease activity participant assessment + VAS disease activity investigator assessment. The maximum score was 334 (66 joints + 68 joints + 100 mm + 100 mm); higher scores indicated higher disease activity."|Weeks 1, 2, 4, 8, 12, 16, 20 and 24|ITT population; only participants with values for CDAI at baseline and the respective visit were included in the analysis.||units on a scale||Standard Deviation|Mean
775135|NCT00754559|Secondary|Change From Baseline in Participant and Physician Assessment of Global Disease Activity (VAS) at Week 24|"Participant’s global assessment of disease activity was an overall assessment of their current disease activity on a 100-mm horizontal VAS scale (left-hand extreme: “no disease activity”; right-hand extreme: “maximum disease activity”).
Physician’s global assessment of disease activity was measured as participant’s current disease activity on a 100-mm horizontal VAS scale (left hand extreme: “no disease activity”; right-hand extreme: “maximum disease activity”)."|Week 24|ITT Population; missing data were imputed using LOCF.||mm||95% Confidence Interval|Mean
775136|NCT00754559|Secondary|Change From Baseline in Participant's Global Assessment of Pain (VAS) at Week 24|Participant's global assessment of pain was assessed using a 100-mm horizontal VAS (0 to 100 mm) with 0=pain absent and 100=unbearable pain. Participants responded by placing a mark on the line to indicate their current level of pain.|Week 24|ITT Population; missing data were imputed using LOCF.||mm||95% Confidence Interval|Mean
775137|NCT00754559|Secondary|Change From Baseline in the Levels of C-Reactive Protein at Week 24|The serum concentration of CRP is measured in mg/L. A reduction in the level was considered an improvement.|Week 24|ITT Population; missing data were imputed using LOCF.||mg/L||95% Confidence Interval|Mean
775138|NCT00754559|Secondary|Change From Baseline in Swollen and Tender Joint Counts at Week 24|"Swollen joint count: 66 joints were assessed for swelling and joints were classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66.
Tender joint counts: 68 joints were assessed for tenderness and joints were classified as tender/not tender giving a total possible tender joint count score of 0 to 68."|Week 24|ITT Population; missing data were imputed using last observation carried forward (LOCF).||Joints||95% Confidence Interval|Mean
775139|NCT00754559|Secondary|Percentage of Participants With an American College of Rheumatology 20%, 50%, or 70% (ACR20/ACR50/ACR70) Response|ACR20/50/70 response: ≥20%, 50%, or 70% improvement, respectively, in swollen and tender joint count; and ≥20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ-DI]); and C-Reactive Protein (CRP).|Weeks 1, 2, 4, 8, 12, 16, 20 and 24|ITT Population||percentage of participants||95% Confidence Interval|Number
775140|NCT00754559|Secondary|Percentage of Participants With a DAS28 Response at Weeks 4 and 24|DAS28 calculated from the number of swollen joints and painful joints using the 28-joint count, the ESR and participant's global assessment (PGA) of disease activity (participant rated arthritis activity assessment using VAS) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 ≤3.2 = low disease activity, DAS28 <2.6 = remission and a clinically significant (CS) reduction was defined as ≥1.2.|Weeks 4 and 24|ITT Population;||percentage of participants||95% Confidence Interval|Number
775141|NCT00754559|Secondary|Percentage of Participants With a Response at Week 24 by European League Against Rheumatism (EULAR) Category|The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 ≤3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to ≤5.1 or change from baseline >0.6 to ≤1.2 with DAS28 ≤5.1; non-responders: change from baseline ≤ 0.6 or change from baseline >0.6 and ≤1.2 with DAS28 >5.1.|Week 24|ITT Population||Percentage of Participants|||Number
775142|NCT00754559|Secondary|Absolute Changes in DAS28 From Baseline|DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hour) and global health assessment (participant rated global assessment of disease activity using 100-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. DAS28 ≤3.2 = low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity.|Weeks 1, 2, 4, 8, 12, 16, 20 and 24|ITT Population; only participants with a DAS28 value at baseline were included in the analysis.||units on a scale||Standard Deviation|Mean
775143|NCT00754559|Primary|Percentage of Participants With Low Disease Activity Score at Week 24|Low Disease Activity Score (LDAS) is defined as Disease Activity score less than or equal to (≤ ) 3.2. Disease activity score 28 (DAS28) was calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and global health assessment (participant rated global assessment of disease activity using 100-mm Visual analog scale [VAS]); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity.|Week 24|ITT population.||Percentage of Participants||95% Confidence Interval|Number
775144|NCT00754572|Secondary|Mean Change in Rheumatoid Factor (RF) at Week 24 in Participants With Positive RF||Baseline and Week 24|Data were not analyzed because of inconsistencies in the pooled data between countries.|||||
775145|NCT00754572|Secondary|Quality of Life (QoL) Assessed by Short-Form 36 (SF-36) at Week 24|SF-36 is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, and mental health. Total of 3 variables were analyzed (2 composite subscales and vitality score). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Week 24|ITT Population; All participants with endpoint values collected at Week 24 were included in the analysis.||score on a scale||Standard Deviation|Mean
775146|NCT00754572|Secondary|Percentage of Participants Achieving Remission (DAS28 Less Than [<] 2.6) at Week 24|DAS28 calculated from the SJC and TJC using the 28 joints count, the ESR (mm/hour) and participant's global assessment of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 (less than or equal to ) ≤3.2 = low disease activity, DAS28 (greater than) >3.2 to 5.1 = moderate to high disease activity and DAS28<2.6 = remission|Week 24|ITT Population; All participants with endpoint values collected at Week 24 were included in the analysis.||percentage of participants||95% Confidence Interval|Number
775147|NCT00754572|Secondary|Fatigue as Assessed Using the Functional Assessment of Chronic Illness Therapy (FACIT-Fatigue) Score at Week 24|FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the participant's health status.|Week 24|ITT Population. All participants with endpoint values collected at Week 24 were included in the analysis.||score on a scale||Standard Deviation|Mean
775148|NCT00754572|Secondary|AUC of DAS28|The AUC was computed using the trapezoidal rule, considering baseline value as 0, through NCSS software. For each participant, AUC for DAS28 units was calculated. Each individual AUC DAS28 value was divided by 52 to have the conversion of AUC DAS28 in unit weeks to AUC DAS28 in unit years, as 1 week is approximately 1/52 years. The set of individual AUC DAS28 was computed as summary statistics.|Weeks 2, 4, 8, 12, 16, 20 and 24|ITT Population; All participants with endpoint values collected were included in the analysis.||scores on a scale * years||Standard Deviation|Mean
775149|NCT00754572|Secondary|Percentage of Participants With a Response by Categorical DAS28 Responses According to The European League Against Rheumatism (EULAR Response) at Week 24|DAS28- based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good response: change from baseline >1.2 with DAS28 < 3.2; moderate response: change from baseline >1.2 with DAS28 >3.2 to <5.1 or change from baseline >0.6 to <1.2 with DAS28 <5.1; No response: change from baseline < 0.6 or change from baseline >0.6 and <1.2 with DAS28 >5.1.|Week 24|ITT Population; All participants with endpoint values collected at Week 24 were included in the analysis.||Percentage of Participants||95% Confidence Interval|Number
775150|NCT00754572|Secondary|Change From Baseline in Disease Activity Score Based on 28 Joint Count (DAS28) at Week 24|DAS28 calculated from the number of SJC and TJC using the 28 joints count, the ESR (mm/hour) and participant's global assessment of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 (less than or equal to ) ≤3.2 = low disease activity, DAS28 (greater than) >3.2 to 5.1 = moderate to high disease activity.|Baseline and Week 24|ITT Population; All participants with endpoint values collected at both baseline and Week 24 were included in the analysis.||score on a scale||Standard Deviation|Mean
775151|NCT00754572|Secondary|Odds Estimates for ACR Positive Response in Generalized Estimating Equation (GEE) Models|The probability of ACR positive response was determined using the GEE.|Weeks 2, 4, 8, 12, 16, 20, 24|ITT Population; All participants with endpoint values collected were included in the analysis.||odds||95% Confidence Interval|Number
775152|NCT00754572|Secondary|Percentage of Participants Achieving ACR20 Response|"ACR20 is defined as 20% improvement in: a) SJC and TJC and b) Three of the following 5 assessments:
Participant's global assessment of pain (VAS)
Participant's global assessment of disease activity (VAS)
Investigator/Physician's global assessment of disease activity (VAS)
Participant's assessment of disability measured by the HAQ-DI
Acute phase reactant levels - ESR or CRP"|Week 2|ITT Population; All participants with endpoint values collected at Week 2 were included in the analysis.||percentage of participants||95% Confidence Interval|Number
775153|NCT00754572|Secondary|Area Under The Curve (AUC) of the ACR(n)|ACR-n was defined as the lowest of 3 values (the percent change in the swollen joint count, the percent change in the tender joint count, and the median of the other 5 measures in the ACR core data set which included Participant's global assessment of pain (VAS), Participant's global assessment of disease activity (VAS), Investigator/Physician's global assessment of disease activity (VAS), Participant's assessment of disability measured by the HAQ-DI Acute phase reactant levels - ESR or CRP). Therefore, a percentage value was assigned to each participant at each timepoint. AUC was calculated for each participant from baseline to Week 112. Mean and standard deviation values are are provided in percent*years.|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|ITT Population; All participants with endpoint values collected were included in the analysis.||percent*years||Standard Deviation|Mean
775154|NCT00754572|Secondary|Percent Change From Baseline in HAQ-DI at Week 24|HAQ-DI includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant's everyday activities: 0=without difficulties; 1=with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3. A positive change from baseline represents an improvement (reduced level of impairment).|Baseline and Week 24|ITT Population. All participants with endpoint values collected at both baseline and Week 24 were included in the analysis.||percent change||Standard Deviation|Mean
775155|NCT00754572|Secondary|HAQ-DI at Baseline and Week 24|HAQ-DI includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant's everyday activities: 0 =without difficulties; 1= with some difficulties; 2=with great difficulties; and 3= unable to perform these actions at all. Minimum score was 0, maximum score was 3. A positive change from baseline represents an improvement (reduced level of impairment).|Baseline and Week 24|ITT Population. All participants with endpoint values collected at the specified timepoints were included in the analysis. n=number of participants analyzed for the given parameter at the specified time point.||units on a scale||Standard Deviation|Mean
775156|NCT00754572|Secondary|Percent Change From Baseline in Physician's Global Assessment of Disease Activity at Week 24|"The physician's global assessment of disease activity is assessed on a 0 to 100 mm VAS by the physician. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm as maximum disease activity (maximum arthritis disease activity). The physicians marked the line corresponding to their assessment and the distance from the left edge was measured. A positive change from baseline represents an improvement (reduced level of disease activity)."|Baseline and Week 24|ITT Population; All participants with endpoint values collected at both baseline and Week 24 were included in the analysis.||percent change||Standard Deviation|Mean
775173|NCT00754624|Secondary|Annual Rate of Change in FVC From Baseline to End of Study||Baseline to 48 months|Safety||Liters per year||Standard Error|Mean
775157|NCT00754572|Secondary|Physician's Global Assessment of Disease Activity at Baseline and Week 24|"The physician's global assessment of disease activity is assessed on a 0 to 100 mm VAS by the physician. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm as maximum disease activity (maximum arthritis disease activity). The physicians marked the line corresponding to their assessment and the distance from the left edge was measured. A positive change from baseline represents an improvement (reduced level of disease activity)."|Baseline and Week 24|ITT Population. All participants with endpoint values collected at the specified timepoints were included in the analysis. n=number of participants analyzed for the given parameter at the specified visit.||mm||Standard Deviation|Mean
775158|NCT00754572|Secondary|Percent Change From Baseline in Participant's Global Assessment of Disease Activity at Week 24|"The participant's global assessment of disease activity is assessed on a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). A positive change from baseline represents an improvement (reduced level of disease activity)."|Baseline and Week 24|ITT Population; All participants with endpoint values collected at both baseline and Week 24 were included in the analysis.||percent change||Standard Deviation|Mean
775159|NCT00754572|Secondary|Participant's Global Assessment of Disease Activity at Baseline and Week 24|"The participant's global assessment of disease activity is assessed on a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). A positive change from baseline represents an improvement (reduced level of disease activity)."|Baseline and Week 24|ITT Population. All participants with endpoint values collected at the specified timepoints were included in the analysis. n= number of participants analyzed for the given parameter at the specified time point.||mm||Standard Deviation|Mean
775160|NCT00754572|Secondary|Percent Change From Baseline in Pain as Assessed by the Participant at Week 24|"The participants assessed their pain using a 0 to 100 millimeter (mm) VAS. The left-hand extreme of the line equals 0 mm, and is described as no pain and the right-hand extreme equals 100 mm as unbearable pain. The participants marked the line corresponding to the level of their pain and the distance from the left edge was measured. A positive change from baseline represents an improvement."|Baseline and Week 24|ITT Population; All participants with endpoint values collected at Baseline and Week 24 were included in the analysis.||percent change||Standard Deviation|Mean
775161|NCT00754572|Secondary|Pain as Assessed by the Participant at Baseline and Week 24|"The participants assessed their pain using a 0 to 100 millimeter (mm) VAS. The left-hand extreme of the line equals 0 mm, and is described as no pain and the right-hand extreme equals 100 mm as unbearable pain. The participants marked the line corresponding to the level of their pain and the distance from the left edge was measured. A positive change from baseline represents an improvement."|Baseline and Week 24|ITT Population; All participants with endpoint values collected at the specified timepoints were included in the analysis. number (n) equals (=) number of participants analyzed for the given parameter at the specified time point.||mm||Standard Deviation|Mean
775162|NCT00754572|Secondary|Percent Change From Baseline in SJC and TJC at Week 24|The number of swollen joints (66 joint count) were scored as swollen=1 and not swollen=0, and the number of tender joints (68 joint count ) were scored as tender=1 and not tender=0, and counted. Scores ranged from 0 to 66 for swollen joint counts and from 0 to 68 for tender joint counts. A positive change from baseline represents an improvement (a reduction in the number of swollen or tender joints).|Baseline and Week 24|ITT Population; All participants with endpoint values collected at both baseline and Week 24 were included in the analysis.||percent change||Standard Deviation|Mean
775163|NCT00754572|Secondary|SJC and TJC at Baseline and Week 24|The number of swollen joints (66 joint count) were scored as swollen=1 and not swollen=0, and the number of tender joints (68 joint count ) were scored as tender=1 and not tender=0, and counted. Scores ranged from 0 to 66 for swollen joint counts and from 0 to 68 for tender joint counts. A positive change from baseline represents an improvement (a reduction in the number of swollen or tender joints).|Baseline and Week 24|ITT Population; All participants with endpoint values collected at both baseline and Week 24 were included in the analysis.||joints||Standard Deviation|Mean
775164|NCT00754572|Secondary|Change From Baseline in Hemoglobin at Week 24||Baseline and Week 24|Data were not analyzed because of inconsistencies in the pooled data between countries.|||||
775165|NCT00754572|Secondary|Time to Onset of ACR20, ACR50, and ACR70|"ACR20, ACR50 and ACR70 are defined as 20, 50 and 70 percent improvement respectively in: a) SJC and TJC and b) Three of the following 5 assessments:
Participant's global assessment of pain by VAS
Participant's global assessment of disease activity (VAS)
Investigator/Physician's global assessment of disease activity (VAS)
Participant's assessment of disability measured by HAQ-DI
Acute phase reactant (ESR or CRP)"|Baseline and Week 24|Data were not analyzed because of inconsistencies in the pooled data between countries.|||||
775166|NCT00754572|Secondary|Percentage of Participants With ACR20 and ACR70 Response at Week 24|"ACR20 and ACR70 are defined as 20 and 70 percent improvement respectively in: a) SJC and TJC and b) Three of the following 5 assessments:
Participant's global assessment of pain by VAS
Participant's global assessment of disease activity (VAS)
Investigator/Physician's global assessment of disease activity (VAS)
Participant's assessment of disability measured by HAQ-DI
Acute phase reactant (ESR or CRP)"|Week 24|ITT Population; All participants with endpoint values collected at Week 24 were included in the analysis.||percentage of participants||95% Confidence Interval|Number
775167|NCT00754572|Primary|Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Week 24|"ACR50 is defined as 50 percent (%) improvement in: a) Swollen Joints Count (SJC) and Tender Joints Count (TJC) and b) Three of the following 5 assessments:
Participant's global assessment of pain by Visual Analog Scale (VAS)
Participant's global assessment of disease activity (VAS)
Investigator/Physician's global assessment of disease activity (VAS)
Participant's assessment of disability measured by the Health Assessment Questionnaire Disability Index (HAQ-DI)
Acute phase reactant levels - Erythrocyte Sedimentation Rate or C-Reactive Protein (ESR or CRP)"|Week 24|ITT Population; All participants with endpoint values collected at Week 24 were included in the analysis.||percentage of participants||95% Confidence Interval|Number
775175|NCT00754650|Secondary|Best Overall Response (BOR)|The percentage of participants in each BOR category (complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD)) is reported. CR was defined as the disappearance of all target (TL) and non-target lesions (non-TL). PR was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD, or the persistence of 1 or more non-TLs. For TLs, SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since treatment started. For non-TLs, SD was defined as the persistence of 1 or more lesions. PD was defined as ≥ 20% increase in the sum of the longest diameter of TLs, taking as reference the smallest SLD recorded since treatment started, the unequivocal progression of existing non-TLs, or the appearance of 1 or more new lesions.|Baseline to the end of treatment (up to 24 weeks)|Intent-to-treat population: All participants who received at least 1 administration of the study drug.||Percentage of participants|||Number
775176|NCT00754650|Primary|Bone Marrow Response|Bone marrow response was defined as the change in percentage of infiltration at the interim staging (after 4 cycles of treatment) and the end of treatment.|Baseline to the end of treatment (up to 24 weeks)|Intent-to-treat population: All participants who received at least 1 administration of the study drug.||Percentage of infiltration||Inter-Quartile Range|Median
775177|NCT00754741|Secondary|Cardiovascular Morbidity and Mortality (Exploratory)||at 36 months post randomization|||participants|||Number
775178|NCT00754741|Secondary|Adherence to Lipid-lowering Drugs|"Adherence is the estimated proportion of the prescribed dose taken over a 3-month period. Therefore, each estimate of medication adherence represented a 3-month window of use prior to and including the endpoint time (e.g., the adherence estimate at 18 months post randomization represented use beginning at 15 months post-randomization and ending at 18 months post-randomization). Pharmacy claims data (i.e., days supply and refill frequency) were used to estimate adherence at each endpoint date."|at 18 months post randomization|||Adherence - proportion||Standard Deviation|Mean
775179|NCT00754741|Secondary|Adherence to Lipid-lowering Drugs|"Adherence is the estimated proportion of the prescribed dose taken over a 3-month period. Therefore, each estimate of medication adherence represented a 3-month window of use prior to and including the endpoint time (e.g., the adherence estimate at 12 months post randomization represented use beginning at 9 months post-randomization and ending at 12 months post-randomization). Pharmacy claims data (i.e., days supply and refill frequency) were used to estimate adherence at each endpoint date."|at 12 months post randomization|||Adherence - proportion||Standard Deviation|Mean
775180|NCT00754741|Secondary|Adherence to Oral Anti-diabetic Medications|"Adherence is the estimated proportion of the prescribed dose taken over a 3-month period. Therefore, each estimate of medication adherence represented a 3-month window of use prior to and including the endpoint time (e.g., the adherence estimate at 18 months post randomization represented use beginning at 15 months post-randomization and ending at 18 months post-randomization). Pharmacy claims data (i.e., days supply and refill frequency) were used to estimate adherence at each endpoint date."|at 18 months post randomization|||Adherence - proportion||Standard Deviation|Mean
775181|NCT00754741|Secondary|Adherence to Oral Anti-diabetic Medications|"Adherence is the estimated proportion of the prescribed dose taken over a 3-month period. Therefore, each estimate of medication adherence represented a 3-month window of use prior to and including the endpoint time (e.g., the adherence estimate at 12 months post randomization represented use beginning at 9 months post-randomization and ending at 12 months post-randomization). Pharmacy claims data (i.e., days supply and refill frequency) were used to estimate adherence at each endpoint date."|at 12 months post randomization|||Adherence - proportion||Standard Deviation|Mean
775182|NCT00754741|Secondary|LDL Cholesterol Levels||at 12 months post randomization|||mg/dL||Standard Deviation|Mean
775183|NCT00754741|Secondary|Glycated Hemoglobin Levels||at 12 months post randomization|||Percent||Standard Deviation|Mean
775184|NCT00754741|Secondary|LDL Cholesterol Levels||at 6 months post randomization|||mg/dL||Standard Deviation|Mean
775185|NCT00754741|Secondary|Glycated Hemoglobin Levels||at 6 months post randomization|||Percent||Standard Deviation|Mean
775186|NCT00754741|Secondary|Cardiovascular Morbidity and Mortality (Exploratory)||at 24 months post randomization|||participants|||Number
775187|NCT00754741|Secondary|Adherence to Lipid-lowering Drugs|"Adherence is the estimated proportion of the prescribed dose taken over a 3-month period. Therefore, each estimate of medication adherence represented a 3-month window of use prior to and including the endpoint time (e.g., the adherence estimate at 6 months post randomization represented use beginning at 3 months post-randomization and ending at 6 months post-randomization). Pharmacy claims data (i.e., days supply and refill frequency) were used to estimate adherence at each endpoint date."|at 6 months post randomization|||Adherence - proportion||Standard Deviation|Mean
775188|NCT00754741|Secondary|Adherence to Oral Anti-diabetic Medications|"Adherence is the estimated proportion of the prescribed dose taken over a 3-month period. Therefore, each estimate of medication adherence represented a 3-month window of use prior to and including the endpoint time (e.g., the adherence estimate at 6 months post randomization represented use beginning at 3 months post-randomization and ending at 6 months post-randomization). Pharmacy claims data (i.e., days supply and refill frequency) were used to estimate adherence at each endpoint date."|at 6 months post randomization|||Adherence - proportion||Standard Deviation|Mean
775189|NCT00754741|Primary|LDL-cholesterol Levels||at 18 months post randomization|||mg/dL||Standard Deviation|Mean
775190|NCT00754741|Primary|Glycated Hemoglobin Levels||at 18 months post randomization|||Percent||Standard Deviation|Mean
775191|NCT00754767|Primary|Vibratory Threshold as Assessed by the Rydel-Seiffer Quantitative Tuning Fork|Data was not analyzed due to study termination|baseline, days 1 and 2 post chemo x 4 cycles||||||
775192|NCT00754793|Primary|Sino-Nasal Outcome Test-20 (SNOT-20)||baseline, 1 month, 3 months||||||
775193|NCT00754832|Secondary|Realtime Digital Fatigue Score|fatigue scored on 0-10 scale with higher scores indicating more fatigue|6 weeks of intervention|||units on a scale||Standard Deviation|Mean
775194|NCT00754832|Secondary|Modified Fatigue Impact Scale|21 item scale, score range 0-84, lower scores indicate less fatigue|6 weeks of intervention|||units on a scale||Standard Deviation|Mean
775365|NCT00756561|Primary|Intratesticular Hormones in Normal Men|Average between right and left testis for each subject and serum hormone concentration in 10 normal men|6-weeks|per protocol||ng/mL||Inter-Quartile Range|Median
775366|NCT00756574|Secondary|Absenteeism|Absent from work because of flu-like illness|over study period|||participants|||Number
775195|NCT00754832|Primary|Fatigue Severity Scale|The Fatigue Severity Scale (FSS)is a self-administered instrument that includes 9 items rated on a 7-point scale, measuring fatigue severity. The subject is asked to score each statement, based on how the statement applied to them over the preceding week. The fatigue severity score is the average of the scores on the 9 questions; scores range from 1-7, with lower scores indicating less fatigue.|after 6 weeks of intervention|intention to treat||units on a scale||Standard Deviation|Mean
775196|NCT00754923|Secondary|Mutational Status for EGFR or Kras||2008-present|||participants|||Number
775197|NCT00754923|Secondary|Toxicity||2008-present||||||
775198|NCT00754923|Secondary|Overall Survival||2008-present||||||
775199|NCT00754923|Primary|Progression-free Survival at 6 Months|"Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions, or similar definition as accurate and appropriate"|6 months|||participants|||Number
775200|NCT00755040|Secondary|Numerical Score of Ocular Surface Disease Index (OSDI) and Development or Lack of Ocular GVHD (by Ophthalmologic Examination) as Measured by Odds Ratio in a Linear Regression Model.|OSDI is a patient reported questionnaire consisting of 12 questions which are scored from 0 to 4. The total scored is computed and depending on the number of questions answered scores are computed which are then categorized into mild, moderate or severe dry eye symptoms. This tool should adequately reflect the morbidity of the dry eye symptoms.|1 year after transplant|Not collected/analysed due to staffing constraints|||||
775201|NCT00755040|Primary|Number of Patients That Develop Ocular GVHD While on Study in the Two Arms (Ocular Cyclosporine (Restasis) vs. Placebo)|Data analysis will be performed on an intention-to-treat basis. Logistic regression will be used to estimate the odds ratio and 95% confidence interval of the two treatment groups with the adjustment of baseline covariates. Outcome comparisons for categorical/dichotomous variables will be assessed by 2 test or Fisher's exact test where expected cell frequencies were <5; continuous variables will be compared by X/2 test or by Mann-Whitney U test where the data are strongly skewed.|Up to 2 years after transplantation|Number of patients that develop ocular GVHD while on study||participants|||Number
775202|NCT00755079|Secondary|Expiratory Respiratory Muscle Strength|Respiratory Muscle Strength defines as Maximal expiratory muscle strength at the mouth.|Outcome will be measured at baseline, prior to intervention, and after 12 weeks of twice daily drug treatment.|||cmH2O||Standard Deviation|Mean
775203|NCT00755079|Primary|Inspiratory Respiratory Muscle Strength|Respiratory muscle strength as measured by maximal inspiratory and pressures at the mouth.|Outcome will be measured at baseline, prior to intervention, and after 12 weeks of twice daily drug treatment.|||cmH2O||Standard Deviation|Mean
775204|NCT00755105|Primary|Rate of Iron Excretion.|Iron excretion calculated as body Fe (mg) times turnover rate estimated from blood activity of Fe55|4 years|Per protocol||milligrams per day||95% Confidence Interval|Mean
775205|NCT00755131|Other Pre-specified|Heart Rate Recovery at Baseline and 6 Months|"The autonomic nervous system (ANS) is the part of the peripheral nervous system that acts as a control system functioning largely below the level of consciousness, and controls visceral functions. It is subdivided into two subsystems: the parasympathetic (vagal) and sympathetic nervous system.
Sympatho-vagal imbalance is evaluated by post-exercise Heart Rate Recovery (HRR), defined as the fall in heart rate during the first minute after exercise (beats/min). HRR is a marker of vagal tone which is a powerful predictor of all-cause mortality in patients with coronary artery disease."|baseline and 6 month follow-up|||beats/min||Standard Deviation|Mean
775206|NCT00755131|Secondary|Peak Oxygen Consumption (VO2peak) at Baseline and 6 Months|Oxygen consumption at peak exercise stress testing (VO2peak) was obtained breath-by-breath with use of a computerized metabolic cart. VO2peak was recorded as the mean value of VO2 during the last 20 s of the test and expressed in millilitres per kilogram per minute.|Baseline and 6-month follow-up|intention to treat (ITT) analysis||ml/kg/min||Standard Deviation|Mean
775207|NCT00755131|Primary|High Mobility Group Box-1 (HMGB1)Levels at Baseline and 6 Months|High mobility group box-1 (HMGB1) is a ubiquitous nuclear protein, constitutively expressed in quiescent cells, where it is involved in several cellular functions, including determination of nucleosomal structure and stability, and binding of transcription factors to DNA sequences. HMGB1 has been recently recognized as a critical mediator of inflammatory processes: the passive release of this protein from necrotic or damaged cells represents an effective stimulus triggering the inflammatory response.|baseline and 6-month follow-up|||ng/ml||Standard Deviation|Mean
775208|NCT00755196|Secondary|Percentage of Participants With Lowering of Overall Target Plaque Severity Score (OTPSS) At Day 7, 14, 28, 42, 56, 70, 91|OTPSS is a scale to assess plaque severity. Each target plaque was scored by the investigator on severity scale ranging from 0 (no plaque) to 8 (very severe plaque), where higher score indicated more severity of a plaque. In this outcome measure, percentage of participants with reduced OTPSS at Day 7, 14, 28, 42, 56, 70 and 91 were reported and comparison of ointment and vehicle treated plaque was given as ‘Ointment treated plaque vs. vehicle treated plaque’ and ‘Vehicle treated plaque vs. ointment treated plaque’.|Day 7, 14, 28, 42, 56, 70, 91|ITT population included all randomized participants who received the study medication.||percentage of participants|||Number
775209|NCT00755196|Primary|Percentage of Participants With Lowering of Overall Target Plaque Severity Score (OTPSS) at Day 84|OTPSS is a scale to assess plaque severity. Each target plaque was scored by the investigator on severity scale ranging from 0 (no plaque) to 8 (very severe plaque), where higher score indicated more severity of a plaque. In this outcome measure, percentage of participants with reduced OTPSS at Day 84 were reported and comparison of ointment and vehicle treated plaque was given as ‘Ointment treated plaque versus (vs.) vehicle treated plaque’ and ‘Vehicle treated plaque vs. ointment treated plaque’.|Day 84|ITT population included all randomized participants who received the study medication.||percentage of participants|||Number
775210|NCT00755222|Primary|Change From Baseline in PDQ Penile Pain|Peyronie's disease penile pain Scale: 0-40 lower numbers reflect 'less penile pain'; higher numbers reflect 'more penile pain' Change from baseline=Week 36 minus baseline. Negative change reflects improvement in the penile pain scale.|Baseline to Week 36 or LOCF|||scores on a scale||Standard Deviation|Mean
775367|NCT00756574|Secondary|Influenza-like Illness|Cough and fever|Over entire study period|||participants|||Number
775368|NCT00756574|Secondary|Physician Visits for Respiratory Illness|visit to primary care MD|one year|||participants|||Number
775218|NCT00755274|Other Pre-specified|Percentage of Participants With at Least a 4-Fold Rise in Influenza Titers After Fluzone® Vaccination (Seroconversion)|Seroconversion was defined as a ≥ 4-fold increase in post-vaccination Hemagglutination inhibition titer. Data presented for participants enrolled at age 36 to 59 months.|Day 28 post-single dose or Day 21 post-Dose 2|"Fold-rises in vaccine Influenza titers were determined in the per-protocol population. (Data is part of Outcome 7, no data were generated for the Naive/Inadequately Primed Group).
One of the enrolled participants in the Primed groups did not have valid post-vaccination serology test data."||Percentage of participants|||Number
775219|NCT00755274|Other Pre-specified|Percentage of Participants With at Least a 4-Fold Rise in Influenza Titers After Fluzone® Vaccination (Seroconversion)|Seroconversion was defined as a ≥ 4-fold increase in post-vaccination Hemagglutination inhibition titer. Data presented for all participants and those enrolled at age 6 to 35 months of age.|Day 28 post-single dose or Day 21 post-Dose 2|"Four-fold rises in vaccine Influenza titers were determined in the per-protocol population.
One each of the enrolled participants in the Primed and Naive groups, respectively, did not have valid post-vaccination serology test data."||Percentage of participants|||Number
775220|NCT00755274|Other Pre-specified|Percentage of Participants With Influenza Titers ≥ 1:40 After Fluzone® Vaccination (Seroprotection)|Seroprotection was defined as a post-vaccination Hemagglutination inhibition titer ≥ 1:40. Data presented for participants enrolled at age 36 to 59 months.|Day 28 post-single dose or Day 21 post-Dose 2|"Seroprotection post-vaccination were determined in the per-protocol population. (Data is part of Outcome 5, no data were generated for the Naive/Inadequately Primed Group).
One of the enrolled participants in the Primed groups did not have valid post-vaccination serology test data."||Percentage of participants|||Number
775221|NCT00755274|Primary|Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2|Solicited local reactions: Tenderness, pain, erythema, and swelling. Systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, irritability, headache, malaise, and myalgia.|Day 0 to Day 3 post-vaccination 2|Safety analysis (post-vaccination 2) was on all enrolled and vaccinated participants with available data, intent-to-treat population. (Data is part of Primary Outcome 1, no data were generated for the Primed Group)||Participants|||Number
775222|NCT00755274|Other Pre-specified|Percentage of Participants With Influenza Titers ≥ 1:40 After Fluzone® Vaccination (Seroprotection)|Seroprotection was defined as a post-vaccination Hemagglutination inhibition titer ≥ 1:40. Data presented for all participants and those enrolled at age 6 to 35 months.|Day 28 post-single dose or Day 21 post-Dose 2|"Seroprotection post-vaccination were determined in the per-protocol population.
One each of the enrolled participants in the Primed and Naive groups, respectively, did not have valid post-vaccination serology test data."||Percentage of participants|||Number
775223|NCT00755274|Other Pre-specified|Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination||Day 28 post-single dose or Day 21 post-Dose 2|"Geometric mean titers (GMTs) to the Influenza vaccine antibodies were determined in the per-protocol population. (Data is part of Outcome 3, no data were generated for the Naive/Inadequately Primed Group).
One of the enrolled participants in the Primed group did not have valid post-vaccination serology test data."||Titers||95% Confidence Interval|Geometric Mean
775224|NCT00755274|Other Pre-specified|Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination||Day 28 post-single dose or Day 21 post-Dose 2|"Geometric mean titers (GMTs) to the Influenza vaccine antibodies were determined in the per-protocol population.
One each of the enrolled participants in the Primed and Naive groups, respectively, did not have valid post-vaccination serology test data."||Titers||95% Confidence Interval|Geometric Mean
775225|NCT00755274|Primary|Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1|Solicited local reactions: Tenderness, pain, erythema, and swelling. Systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, irritability, headache, malaise, and myalgia.|Day 0 to Day 3 post-vaccination 1|Safety analysis was on all enrolled and vaccinated participants with available post-vaccination 1 data, intent-to-treat population.||Participants|||Number
775226|NCT00755417|Primary|Change From Baseline in Average Daily Severity Score of Hot Flashes After 12 Weeks of Treatment With Daily Doses of G-ER 1200 mg or G-ER 1800 mg Compared to Placebo|Change from baseline in average daily severity score of moderate to severe hot flashes after 12 weeks of treatment with stable daily doses of G-ER 1200 mg or G-ER 1800 mg compared with placebo, using last observation carried forward (LOCF) method of imputation for missing data in intent-to-treat (ITT) population. Severity score is on a 3-point scale were 1=Mild, 2=Moderate, and 3=Severe.|From baseline to 12 weeks|||Score on a numerical scale||95% Confidence Interval|Least Squares Mean
775227|NCT00755417|Primary|Change From Baseline in Average Daily Severity Score of Hot Flashes After 4 Weeks of Treatment With Daily Doses of G-ER 1200 mg or G-ER 1800 mg Compared to Placebo|Change from baseline in average daily severity score of moderate to severe hot flashes after 4 weeks of treatment with stable daily doses of G-ER 1200 mg or G-ER 1800 mg compared with placebo, using last observation carried forward (LOCF) method of imputation for missing data in intent-to-treat (ITT) population. Severity score is on a 3-point scale where 1=Mild, 2=Moderate, and 3=Severe.|From baseline to 4 weeks|||Score on a numerical scale||95% Confidence Interval|Least Squares Mean
775228|NCT00755417|Primary|Change From Baseline in Average Daily Frequency of Hot Flashes After 12 Weeks of Treatment With Daily Doses of G-ER 1200 mg or G-ER 1800 mg Compared to Placebo|Change from baseline in average daily frequency of moderate to severe hot flashes after 12 weeks of treatment with stable daily doses of G-ER 1200 mg or G-ER 1800 mg compared with placebo, using last observation carried forward (LOCF) method of imputation for missing data in intent-to-treat (ITT) population.|Form baseline to 12 weeks|||Moderate or severe hot flashes||95% Confidence Interval|Least Squares Mean
775229|NCT00755417|Primary|Change From Baseline in Average Daily Frequency of Hot Flashes After 4 Weeks of Treatment With Daily Doses of G-ER 1200 mg or G-ER 1800 mg Compared to Placebo|Change from baseline in average daily frequency of moderate to severe hot flashes after 4 weeks of treatment with stable daily doses of G-ER 1200 mg or G-ER 1800 mg compared with placebo, using last observation carried forward (LOCF) method of imputation for missing data in intent-to-treat (ITT) population.|From baseline to 4 weeks|||Moderate or severe hot flashes||95% Confidence Interval|Least Squares Mean
775369|NCT00756574|Primary|Laboratory-confirmed Influenza Infection|Laboratory confirmed influenza|one year|||participants|||Number
775232|NCT00755755|Primary|Co-primary Endpoint: Percent Change in Total Myoma Volume Assessed by Magnetic Resonance Imaging (MRI) From Screening to End of Treatment Visit (Week 13 Visit)|Percent change in total fibroid volume from screening to end of treatment visit (Week 13 visit) assessed by MRI and read centrally by a radiologist who was unaware of the study-group assignments. The total fibroid volume was the sum of the individual fibroid volumes.|Week 13|Intent-to-treat||percentage of change||Full Range|Median
775233|NCT00755755|Primary|Co-primary Endpoint: Percentage of Subjects With Reduction in Uterine Bleeding Defined as a Pictorial Blood-loss Assessment Chart (PBAC) Score <75 at End-of-treatment Visit (Week 13)|"Uterine bleeding was assessed with the use of the PBAC, a validated self-reporting method to estimate menstrual blood loss.
Patients recorded daily the number of tampons and towels used and the degree to which individual items were soiled with blood (plus small or large clots). Monthly scores range from 0 (amenorrhea) to more than 500, with higher numbers indicating more bleeding.
A slightly stained tampon/towel scores 1, a partially stained tampon/towel scores 5, a completely saturated tampon scores 10 and a completely saturated towel scores 20. Small clots/flooding (2cm) score 1. Large clots/flooding (3cm) score 5.
Menorrhagia is defined as a PBAC > 100 during one menstrual period which approximates to a blood loss of > 80 mL. A PBAC of 400 corresponds to a blood loss of around 300 mL or approximately 80 tampons/towels used.
The week 13 PBAC score was calculated using the last 28 days of treatment."|Week 13 visit|Intent-to-treat||percentage of patients|||Number
775234|NCT00755807|Secondary|Change From Baseline in Weight at Week 18 (Open-label Extension Phase)||Baseline (6 weeks), Endpoint (18 weeks)|Number of randomized participants who entered and had at least 1 non-missing value during extension phase.||kilograms (kg)||Standard Deviation|Mean
775235|NCT00755807|Secondary|Change From Baseline in Pulse Rate at Week 18 (Open-label Extension Phase)||Baseline (6 weeks), endpoint (18 weeks)|Number of randomized participants who entered and had at least 1 non-missing value during extension phase.||beats per minute (bpm)||Standard Deviation|Mean
775236|NCT00755807|Secondary|Change From Baseline in Blood Pressure at Week 18 (Open-label Extension Phase)||Baseline (6 weeks), Endpoint (18 weeks)|Number of randomized participants who entered and had at least 1 non-missing value during extension phase.||mm Hg||Standard Deviation|Mean
775237|NCT00755807|Other Pre-specified|Change From Baseline in Total Protein at Week 18 (Open-label Extension Phase)||Baseline (6 weeks), Endpoint (18 weeks)|Number of randomized participants who entered and had at least 1 non-missing value during extension phase.||gram/deciliter (g/dL)||Standard Deviation|Mean
775238|NCT00755807|Other Pre-specified|Change From Baseline in Sodium at Week 18 (Open-label Extension Phase)||Baseline (6 weeks), Endpoint (18 weeks)|Number of randomized participants who entered and had at least 1 non-missing value during extension phase.||milliEq/Liter||Standard Deviation|Mean
775239|NCT00755807|Other Pre-specified|Change From Baseline in Monocytes at Week 18 (Open-label Extension Phase)||Baseline (6 weeks), Endpoint (18 weeks)|Number of randomized participants who entered and had at least 1 non-missing value during extension phase.||Thousand/microliter||Standard Deviation|Mean
775240|NCT00755807|Secondary|Number of Participants With Adverse Events (AEs) Resulting in Discontinuation During the Open-label Extension Phase||Baseline (6 weeks) through Endpoint (18 weeks)|All randomized participants in the open-label extension phase.||participants|||Number
775241|NCT00755807|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Open-label Extension Phase|Summary tables of serious adverse events (SAEs) and all other non-serious adverse events are located in the Reported Adverse Event Module.|Baseline (6 weeks) through Endpoint (18 weeks)|All randomized participants in the open-label extension phase.||participants|||Number
775242|NCT00755807|Secondary|Number of Participants Who Discontinued During the Open-label Extension Phase (by Week 18)||Baseline (6 weeks) through Endpoint (18 weeks)|All participants randomized to placebo in acute phase received duloxetine during the extension phase.||participants|||Number
775243|NCT00755807|Secondary|Change From Baseline in Beck Depression Inventory II (BDI-II), Question #9 at Week 18 (Open-label Extension Phase)|The BDI-II is completed by the participant to rate the severity of depressive symptoms and any improvement during the course of the trial. The total score ranges from 0 to 63 with higher the score indicating more severe depressive symptoms. Question #9 is suicidal thoughts and wishes with the score ranging from 0 to 3.|Baseline (6 weeks), Endpoint (18 weeks)|Number of randomized participants who entered and had at least 1 non-missing value during extension phase.||units on a scale||Standard Deviation|Mean
775244|NCT00755807|Secondary|Change in the Weekly Mean of the Night Pain Scores From Week 6 Through Week 18 (Open-label Extension Phase)|Weekly mean of the night pain severity scores recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Participants should complete the electronic diary each day upon awakening. Each weekly mean change represents change relative to week 6, the baseline of the extension phase.|Baseline (6 weeks) through Endpoint (18 weeks)|Number of randomized participants who entered and had at least 1 non-missing value during extension phase.||units on a scale||Standard Error|Least Squares Mean
775245|NCT00755807|Secondary|Number of Participants With Suicidal Behaviors, Ideations, and Acts Based on The Columbia Suicide Severity Rating Scale (C-SSRS) at Week 18|"C-SSRS scale captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors, ideations, and acts are provided. Suicidal behavior: a “yes” answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a “yes” answer to any one of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation. Suicidal act: a yes answer to actual attempt or completed suicide."|18 weeks|All randomized participants who entered the extension phase.||participants|||Number
791678|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Urine Red Blood Cells [RBC]).||Baseline up to Month 7|||percentage of participants|||Number
775246|NCT00755807|Secondary|Change From Baseline in Multiple Sclerosis Quality of Life-54 Instrument (MS-QOL-54) at Week 18 (Open-label Extension Phase)|A 54 question measure covers 12 domains; assesses mental and physical health. Each domain score is converted into a 0-100 score based on individual item responses; higher scores=better health status. The physical health composite score is a weighted average of the physical health scales, such as physical function, health perceptions, and energy. The mental health composite score is a weighted average of the mental health scales, such as overall quality of life, cognitive function, and health distress.|Baseline (6 weeks), Endpoint (18 weeks)|Number of randomized participants who entered and had at least 1 non-missing value during extension phase.||units on a scale||Standard Deviation|Mean
775247|NCT00755807|Secondary|Change From Baseline in the Clinical Global Impression of Severity Scale (CGI-S) Score at Week 18 (Open-label Extension Phase)|Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).|Baseline (6 weeks), Endpoint (18 weeks)|Number of randomized participants who entered and had at least 1 non-missing value during extension phase.||units on a scale||Standard Deviation|Mean
775248|NCT00755807|Secondary|Change From Baseline in Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 18|BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items.|Baseline (end of acute phase/Week 6), Endpoint (Week 18)|Number of randomized participants who entered and had at least 1 non-missing value during extension phase.||units on a scale||Standard Deviation|Mean
775249|NCT00755807|Secondary|Patient Global Impressions of Improvement Scale (PGI-I) Score at 18 Weeks|A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The scores range from 1 (very much better) to 7 (very much worse).|18 weeks|Number of randomized participants who entered and had at least 1 non-missing value during extension phase.||units on a scale||Standard Deviation|Mean
775250|NCT00755807|Secondary|Change From Baseline in Weight at Week 6 (Acute Phase)||Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value.||kilograms (kg)||Standard Error|Least Squares Mean
775251|NCT00755807|Secondary|Change From Baseline in Pulse Rate at Week 6 (Acute Phase)||Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value.||beats per minute (bpm)||Standard Error|Least Squares Mean
775252|NCT00755807|Secondary|Change From Baseline in Blood Pressure at Week 6 (Acute Phase)||Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value.||mm Hg||Standard Error|Least Squares Mean
775253|NCT00755807|Other Pre-specified|Change From Baseline in Uric Acid at Week 6 (Acute Phase)|Change from baseline to acute phase endpoint in laboratory assessment of uric acid.|Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value.||mg/dL||Standard Deviation|Mean
775254|NCT00755807|Other Pre-specified|Change From Baseline in Inorganic Phosphorus at Week 6 (Acute Phase)|Change from baseline to acute phase endpoint in laboratory assessment of inorganic phosphorus.|Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value.||mg/dL||Standard Deviation|Mean
775255|NCT00755807|Other Pre-specified|Change From Baseline in the Platelet Count at Week 6 (Acute Phase)|Change from baseline to acute phase endpoint in laboratory assessment of platelet count.|Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value.||Thousand/microliter||Standard Deviation|Mean
775256|NCT00755807|Other Pre-specified|Change From Baseline in Creatinine at Week 6 (Acute Phase)|Change from baseline to acute phase endpoint in laboratory assessment of creatinine.|Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value.||milligram/deciliter (mg/dL)||Standard Deviation|Mean
775257|NCT00755807|Other Pre-specified|Change From Baseline in Bicarbonate (HCO3) at Week 6 (Acute Phase)|Change from baseline to acute phase endpoint in laboratory assessment for bicarbonate, HCO3.|Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value.||milliEq/Liter||Standard Deviation|Mean
775258|NCT00755807|Secondary|Number of Participants With Adverse Events (AEs) Resulting in Discontinuation From Baseline During the Acute Phase||Baseline through 6 weeks|All randomized participants.||participants|||Number
775259|NCT00755807|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Acute Phase|Summary tables of serious adverse events (SAEs) and all other non-serious adverse events are located in the Reported Adverse Event Module.|Baseline through 6 weeks|All randomized participants.||participants|||Number
775260|NCT00755807|Secondary|Number of Participants Who Discontinued During the Acute Phase (by Week 6)||Baseline through 6 weeks|All randomized participants.||participants|||Number
775261|NCT00755807|Secondary|Change From Baseline in the Beck Depression Inventory II (BDI-II) Question #9 at Week 6 (Acute Phase)|The BDI-II is completed by the participant to rate the severity of depressive symptoms and any improvement during the course of the trial. The total score ranges from 0 to 63 with higher the score indicating more severe depressive symptoms. Question #9 is suicidal thoughts and wishes with a score ranging from 0 to 3.|Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value.||units on a scale||Standard Deviation|Mean
775262|NCT00755807|Secondary|Change From Baseline in the Weekly Mean of Night Pain Scores at Week 6 (Acute Phase)|Weekly mean of the night pain severity scores recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Participants should complete the electronic diary each day upon awakening. The Least Squares (LS) Mean Value was adjusted for investigative site and baseline severity.|Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value.||units on a scale||Standard Error|Least Squares Mean
775459|NCT00757484|Secondary|Percentage of Participants Undergoing Different Types of Anesthesia|Patients were given either general, regional or local-modified anesthesia care (LO-MAC). Some of the patients ended up getting both general and regional anesthesia (sometimes anesthesia team decides to add regional for postop pain control).|January 2007 to January 2008|||percentage of participants|||Number
775263|NCT00755807|Secondary|Number of Participants With Suicidal Behaviors, Ideations, and Acts Based on The Columbia Suicide Severity Rating Scale (C-SSRS) at Week 6|"C-SSRS scale captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors, ideations, and acts are provided. Suicidal behavior: a “yes” answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a “yes” answer to any one of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation. Suicidal act: a yes answer to actual attempt or completed suicide."|6 weeks|All randomized participants.||participants|||Number
775264|NCT00755807|Secondary|Change From Baseline in the Multiple Sclerosis Quality of Life-54 Instrument (MS-QOL-54) at 6 Weeks (Acute Phase)|A 54 question measure covers 12 domains; assesses mental and physical health. Each domain score is converted into a 0-100 score based on individual item responses; higher scores=better health status. The physical health composite score is a weighted average of the physical health scales, such as physical function, health perceptions, and energy. The mental health composite score is a weighted average of the mental health scales, such as overall quality of life, cognitive function, and health distress. The Least Squares (LS) Mean Value was adjusted for investigative site and baseline severity.|Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value.||units on a scale||Standard Error|Least Squares Mean
775265|NCT00755807|Secondary|Change From Baseline in the Clinical Global Impression of Severity Scale (CGI-S) at 6 Weeks (Acute Phase)|Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). The Least Squares (LS) Mean Value was adjusted for investigative site and baseline severity.|Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value.||units on a scale||Standard Error|Least Squares Mean
775266|NCT00755807|Secondary|Change From Baseline in the Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 6 (Acute Phase)|Measures pain severity and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst, least, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing pain interference in past 24 hours, such as general activity, mood, normal work, relations with other people, and sleep. Average interference=average of non-missing scores of individual interference items. Least Squares (LS) Mean Value was adjusted for investigative site and baseline severity.|Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value.||units on a scale||Standard Error|Least Squares Mean
775267|NCT00755807|Secondary|Patient Global Impressions of Improvement Scale (PGI-I) at 6 Weeks|A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). The Least Squares (LS) Mean Value was adjusted for investigative site and baseline severity.|6 weeks|Number of randomized participants with at least 1 post-baseline value. Last-observation-carried-forward (LOCF) imputation was implemented.||units on a scale||Standard Error|Least Squares Mean
775268|NCT00755807|Secondary|Change From Baseline in the Weekly 24-Hour Average Pain Scores up to Week 6 (Acute Phase)|This is a nominal outcome reflecting whether or not a clinically-important efficacy outcome (≥30% or ≥50% pain reduction from baseline) was achieved at endpoint. It is based on a comparison between baseline and endpoint scores on an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Used were the weekly mean of the scores of the average pain severity over the last 24 hours. The weekly averages were based on daily assessments recorded by participants in their diaries.|Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value. Last-observation-carried-forward (LOCF) imputation was implemented for participants with early discontinuation. Baseline-observation-carried-forward (BOCF) imputation was implemented for participants with early discontinuation.||participants|||Number
775269|NCT00755807|Primary|Change From Baseline in the Weekly 24-Hour Average Pain Scores at Week 6 (Acute Phase)|24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean, with scores ranging from 0 (no pain) to 10 (worst possible pain). Participants should complete electronic diary each day upon awakening. The 11-point Likert scale was used for assessment of 24-hour average pain and evaluated as weekly means. Scores range from 0 (no pain) to 10 (worst possible pain). The Least Squares Mean (LS Mean) Value was adjusted for investigative site and baseline severity.|Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value.||units on a scale||Standard Error|Least Squares Mean
775270|NCT00755846|Secondary|Mean Percent Incidence of Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg/dL).|The incidence of marked hyperglycemia occurring in participants with a fasting plasma glucose value greater than or equal to 200 mg per dL during study. Overall mean obtained by weighting the hyperglycemia percent incidence values at each time point by number of days in between visits. Mean percent incidence of marked hyperglycemia at each time point is the percent of self-monitored blood glucose measurements greater than or equal to 200 mg per dL, calculated per participant and then averaged across population.|85 Days.|"Randomized participants who received at least 1 dose of study drug (Intent to Treat), and who had at least 1 fasting plasma glucose measurement after baseline.
Note: Mean percent incidence of marked hyperglycemia was only summarized by treatment group using descriptive statistics."||percent incidence||Standard Deviation|Mean
775271|NCT00755846|Secondary|Change From Baseline in Triglycerides (Day 85).|The change between triglycerides collected at day 85 or final visit and triglycerides collected at baseline.|Baseline and Day 85.|Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 85. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
775272|NCT00755846|Secondary|Change From Baseline in Triglycerides (Day 43).|The change between triglycerides collected at day 43 and triglycerides collected at baseline.|Baseline and Day 43.|Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 43. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
775460|NCT00757484|Secondary|Percentage of Women With Asymptomatic Hypotension|% women with asymptomatic hypotension|1 year|||percentage of participants|||Number
791679|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Serum Creatinine).||Baseline up to Month 7|||percentage of participants|||Number
775273|NCT00755846|Secondary|Change From Baseline in Low-Density Lipoprotein Cholesterol (Day 85).|The change between low-density lipoprotein cholesterol collected at day 85 or final visit and low-density lipoprotein cholesterol collected at baseline.|Baseline and Day 85.|Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 85. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
775274|NCT00755846|Secondary|Change From Baseline in Low-Density Lipoprotein Cholesterol (Day 43).|The change between low-density lipoprotein cholesterol collected at day 43 and low-density lipoprotein cholesterol collected at baseline.|Baseline and Day 43.|Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 43. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
775275|NCT00755846|Secondary|Change From Baseline in High-Density Lipoprotein Cholesterol (Day 85).|The change between high-density lipoprotein cholesterol collected at day 85 or final visit and high-density lipoprotein cholesterol collected at baseline.|Baseline and Day 85.|Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 85. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
775276|NCT00755846|Secondary|Change From Baseline in High-Density Lipoprotein Cholesterol (Day 43).|The change between high-density lipoprotein cholesterol collected at day 43 and high-density lipoprotein cholesterol collected at baseline.|Baseline and Day 43.|Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 43. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
775277|NCT00755846|Secondary|Change From Baseline in Total Cholesterol (Day 85).|The change between the value of cholesterol collected at day 85 or final visit and cholesterol collected at baseline.|Baseline and Day 85.|Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 85. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
775278|NCT00755846|Secondary|Change From Baseline in Total Cholesterol (Day 43).|The change between the value of cholesterol collected at day 43 and cholesterol collected at baseline.|Baseline and Day 43|Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 43. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
775279|NCT00755846|Secondary|Change From Baseline in Fasting Fructosamine (Day 85).|The change between the value of fasting fructosamine collected at day 85 or final visit and fasting fructosamine collected at baseline.|Baseline and Day 85.|Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 85. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
775280|NCT00755846|Secondary|Change From Baseline in Fasting Fructosamine (Day 43).|The change between the value of fasting fructosamine collected at day 43 and fasting fructosamine collected at baseline.|Baseline and Day 43.|Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 43. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
775281|NCT00755846|Secondary|Change From Baseline in Fasting Plasma Glucose (Day 85).|The change between the value of fasting plasma glucose collected at day 85 or final visit and fasting plasma glucose collected at baseline.|Baseline and Day 85.|Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 85. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
775282|NCT00755846|Secondary|Change From Baseline in Fasting Plasma Glucose (Day 43).|The change between the value of fasting plasma glucose collected at day 43 and fasting plasma glucose collected at baseline.|Baseline and Day 43|Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 43. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
775283|NCT00755846|Secondary|Change From Baseline in Glycosylated Hemoglobin at Day 43.|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at day 43 and glycosylated hemoglobin collected at baseline.|Baseline and Day 43.|Randomized subjects who received at least 1 dose of study drug (Intent to treat), and who had measurements at baseline and at Day 43. Missing data are imputed using last observation carried forward (LOCF).||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
775284|NCT00755846|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 85.|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at day 85 or final visit and glycosylated hemoglobin collected at baseline.|Baseline and Day 85.|Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 85. Missing data are imputed using last observation carried forward (LOCF).||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
775285|NCT00755911|Secondary|Number of Participants Who Successfully Received Dental Implant Fixtures|The secondary objective is to determine if Tissue Repair Cell therapy regenerates bone enabling the installation and stability of dental implant fixtures|12 months after tooth extraction|||participants|||Number
775286|NCT00755911|Primary|Bone Regeneration|"The primary objective of this study is to determine whether the placement of Tissue Repair Cells (TRCs) at the time of tooth extraction can safely and effectively promote bone regeneration in alveolar bone defects created by tooth extraction.
Safety was assessed through adverse event reporting
Bone regeneration was assessed through measures of bone mineral density and bone volume fraction of biopsied regenerated bone tissue. Bone regeneration was also measured through radiographic analysis of relative bone height gain (% of the bone height regenerated relative to the height before tooth extraction)"|12 months after tooth extraction|||% bone height||Standard Deviation|Mean
775287|NCT00755937|Secondary|Number of Serious Adverse Events||Throughout study (up to 36 months)|Safety data were collected for all patients registered. Total number of subjects: 556. Non serious adverse events: 198. Serious Adverse Events: 105.||Number of Serious Adverse Events|||Number
775288|NCT00755937|Primary|Clinical Remission at 36 Months (CDAI <= 150 Points).|CDAI is calculated based on 8 factors: # of liquid stools, abdominal pain, patient well-being, Crohn's complications, need for anti-diarrheal medications, abdominal mass, hematocrit, and weight. CDAI can range from 0 to 600. Remission is < 150, and moderate to severe disease ranges from 220 to 450.|36 months after baseline|Patients at 36 months: Patients with at least 36 months of follow-up. Imputation for missing values used either the last observation carried forward or last observation carried backward, whichever had the highest CDAI.||Participants|||Number
775289|NCT00755937|Primary|Clinical Remission at 24 Months (CDAI <= 150 Points).|CDAI is calculated based on 8 factors: # of liquid stools, abdominal pain, patient well-being, Crohn's complications, need for anti-diarrheal medications, abdominal mass, hematocrit, and weight. CDAI can range from 0 to 600. Remission is < 150, and moderate to severe disease ranges from 220 to 450.|24 months after baseline|Patients at 24 months: Patients with at least 24 months of follow-up. Imputation for missing values used either the last observation carried forward or last observation carried backward, whichever had the highest CDAI.||Participants|||Number
775290|NCT00755937|Primary|Clinical Remission at 12 Months (CDAI <= 150 Points).|CDAI is calculated based on 8 factors: # of liquid stools, abdominal pain, patient well-being, Crohn's complications, need for anti-diarrheal medications, abdominal mass, hematocrit, and weight. CDAI can range from 0 to 600. Remission is < 150, and moderate to severe disease ranges from 220 to 450.|12 months after baseline|Patients at 12 months: Patients with at least 12 months of follow-up. Imputation for missing values used either the last observation carried forward or last observation carried backward, whichever had the highest CDAI.||Participants|||Number
775291|NCT00755937|Primary|Clinical Response at 36 Months (Decrease in CDAI >= 70 Points AND >= 25% From Baseline).|CDAI is calculated based on 8 factors: # of liquid stools, abdominal pain, patient well-being, Crohn's complications, need for anti-diarrheal medications, abdominal mass, hematocrit, and weight. CDAI can range from 0 to 600. Remission is < 150, and moderate to severe disease ranges from 220 to 450.|36 months after baseline|Patients at 36 months: Patients with at least 36 months of follow-up. Imputation for missing values used either the last observation carried forward or last observation carried backward, whichever had the highest CDAI.||Participants|||Number
775292|NCT00755937|Primary|Clinical Response at 24 Months (Decrease in CDAI >= 70 Points AND >= 25% From Baseline).|CDAI is calculated based on 8 factors: # of liquid stools, abdominal pain, patient well-being, Crohn's complications, need for anti-diarrheal medications, abdominal mass, hematocrit, and weight. CDAI can range from 0 to 600. Remission is < 150, and moderate to severe disease ranges from 220 to 450.|24 months after baseline|Patients at 24 months: Patients with at least 24 months of follow-up. Imputation for missing values used either the last observation carried forward or last observation carried backward, whichever had the highest CDAI.||Participants|||Number
775293|NCT00755937|Primary|Clinical Response at 12 Months (Decrease in Crohn's Disease Activity Index [CDAI]>= 70 Points AND >= 25% From Baseline).|CDAI is calculated based on 8 factors: # of liquid stools, abdominal pain, patient well-being, Crohn's complications, need for anti-diarrheal medications, abdominal mass, hematocrit, and weight. CDAI can range from 0 to 600. Remission is < 150, and moderate to severe disease ranges from 220 to 450.|12 months after baseline|Patients at 12 months: Patients with at least 12 months of follow-up. Imputation for missing values used either the last observation carried forward or last observation carried backward, whichever had the highest CDAI.||Participants|||Number
775294|NCT00756002|Secondary|Subjective Number of Awakenings, Per Post-sleep Questionnaire (Week 5).|The Subjective Number of Awakenings weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural “home” setting.|Week 5|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||scores on a scale||Standard Error|Least Squares Mean
775295|NCT00756002|Secondary|Subjective Number of Awakenings, Per Post-sleep Questionnaire (Week 4).|The Subjective Number of Awakenings weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural “home” setting.|Week 4|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||scores on a scale||Standard Error|Least Squares Mean
775296|NCT00756002|Secondary|Subjective Number of Awakenings, Per Post-sleep Questionnaire (Week 2).|The Subjective Number of Awakenings weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural “home” setting.|Week 2|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||scores on a scale||Standard Error|Least Squares Mean
775297|NCT00756002|Secondary|Subjective Number of Awakenings, Per Post-sleep Questionnaire (Nights 29-30).|Subjective Number of Awakenings (the subjective measure of how many times the subject believes they awoke during the night) obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography. The average of two nights' data is used for each subject at a visit.|Nights 29-30|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||Number of awakenings per night||Standard Error|Least Squares Mean
775298|NCT00756002|Secondary|Subjective Number of Awakenings, Per Post-sleep Questionnaire (Nights 15-16).|Subjective Number of Awakenings (the subjective measure of how many times the subject believes they awoke during the night) obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography. The average of two nights' data is used for each subject at a visit.|Nights 15-16|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||Number of awakenings per night||Standard Error|Least Squares Mean
775299|NCT00756002|Secondary|Subjective Number of Awakenings, Per Post-sleep Questionnaire (Nights 1-2).|Subjective Number of Awakenings (the subjective measure of how many times the subject believes they awoke during the night) obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography. The average of two nights' data is used for each subject at a visit.|Nights 1-2|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||Number of awakenings per night||Standard Error|Least Squares Mean
775300|NCT00756002|Secondary|Number of Awakenings After Persistent Sleep, Per Polysomnography (Nights 29-30).|Number of Awakenings is defined as the number of times after the onset of persistent sleep that there is a wake entry of at least 2 epochs in duration. Each entry must be separated by Stage 2, 3/4 NREM sleep or REM sleep in order to be counted.|Nights 29-30|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||awakenings after persistent sleep||Standard Error|Least Squares Mean
775301|NCT00756002|Secondary|Number of Awakenings After Persistent Sleep, Per Polysomnography (Nights 15-16).|Number of Awakenings is defined as the number of times after the onset of persistent sleep that there is a wake entry of at least 2 epochs in duration. Each entry must be separated by Stage 2, 3/4 NREM sleep or REM sleep in order to be counted.|Nights 15-16|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||awakenings after persistent sleep||Standard Error|Least Squares Mean
775302|NCT00756002|Secondary|Number of Awakenings After Persistent Sleep, Per Polysomnography (Nights 1-2).|Number of Awakenings is defined as the number of times after the onset of persistent sleep that there is a wake entry of at least 2 epochs in duration. Each entry must be separated by Stage 2, 3/4 NREM sleep or REM sleep in order to be counted.|Nights 1-2|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||awakenings after persistent sleep||Standard Error|Least Squares Mean
775303|NCT00756002|Secondary|Subjective Wake Time After Sleep Onset, Per Post-sleep Questionnaire (Week 5).|The Subjective Wake Time After Sleep Onset weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural “home” setting.|Week 5|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||minutes||Standard Error|Least Squares Mean
775304|NCT00756002|Secondary|Subjective Wake Time After Sleep Onset, Per Post-sleep Questionnaire (Week 4).|The Subjective Wake Time After Sleep Onset weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural “home” setting.|Week 4|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||minutes||Standard Error|Least Squares Mean
775305|NCT00756002|Secondary|Subjective Wake Time After Sleep Onset, Per Post-sleep Questionnaire (Week 2).|The Subjective Wake Time After Sleep Onset weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural “home” setting.|Week 2|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||minutes||Standard Error|Least Squares Mean
775306|NCT00756002|Secondary|Subjective Wake Time After Sleep Onset, Per Post-sleep Questionnaire (Nights 29-30).|Subjective Wake Time After Sleep Onset obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography.|Nights 29-30|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||minutes||Standard Error|Least Squares Mean
775307|NCT00756002|Secondary|Subjective Wake Time After Sleep Onset, Per Post-sleep Questionnaire (Nights 15-16).|Subjective Wake Time After Sleep Onset obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography.|Nights 15-16|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||minutes||Standard Error|Least Squares Mean
775308|NCT00756002|Secondary|Subjective Wake Time After Sleep Onset, Per Post-sleep Questionnaire (Nights 1-2).|Subjective Wake Time After Sleep Onset obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography.|Nights 1-2|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||minutes||Standard Error|Least Squares Mean
775309|NCT00756002|Secondary|Wake Time After Sleep Onset, Per Polysomnography (Nights 29-30).|The number of minutes in the Awake stage after the onset of persistent sleep to the end of the recording.|Nights 29-30|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||minutes||Standard Error|Least Squares Mean
775310|NCT00756002|Secondary|Wake Time After Sleep Onset, Per Polysomnography (Nights 15-16).|The number of minutes in the Awake stage after the onset of persistent sleep to the end of the recording.|Nights 15-16|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||minutes||Standard Error|Least Squares Mean
775311|NCT00756002|Secondary|Wake Time After Sleep Onset, Per Polysomnography (Nights 1-2).|The number of minutes in the Awake stage after the onset of persistent sleep to the end of the recording.|Nights 1-2|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||minutes||Standard Error|Least Squares Mean
775312|NCT00756002|Secondary|Subjective Sleep Quality, Per Post-sleep Questionnaire (Week 5).|The subjective sleep quality weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural “home” setting. 7=Extremely Poor; 6=Very Poor; 5=Poor; 4=Fair; 3=Good; 2=Very Good; 1=Excellent.|Week 5|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||scores on a scale||Standard Error|Least Squares Mean
775313|NCT00756002|Secondary|Subjective Sleep Quality, Per Post-sleep Questionnaire (Week 4).|The subjective sleep quality weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural “home” setting. 7=Extremely Poor; 6=Very Poor; 5=Poor; 4=Fair; 3=Good; 2=Very Good; 1=Excellent.|Week 4|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||scores on a scale||Standard Error|Least Squares Mean
775314|NCT00756002|Secondary|Subjective Sleep Quality, Per Post-sleep Questionnaire (Week 2).|The subjective sleep quality weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural “home” setting. 7=Extremely Poor; 6=Very Poor; 5=Poor; 4=Fair; 3=Good; 2=Very Good; 1=Excellent.|Week 2|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||scores on a scale||Standard Error|Least Squares Mean
775315|NCT00756002|Secondary|Subjective Sleep Quality, Per Post-sleep Questionnaire (Nights 29-30).|Sleep quality obtained from the Post-Sleep Questionnaireperformed in the sleep lab the morning following overnight Polysomnography. 7=Extremely Poor; 6=Very Poor; 5=Poor; 4=Fair; 3=Good; 2=Very Good; 1=Excellent.|Nights 29-30|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||scores on a scale||Standard Error|Least Squares Mean
775316|NCT00756002|Secondary|Subjective Sleep Quality, Per Post-sleep Questionnaire (Nights 15-16).|Sleep quality obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography. 7=Extremely Poor; 6=Very Poor; 5=Poor; 4=Fair; 3=Good; 2=Very Good; 1=Excellent.|Nights 15-16|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||scores on a scale||Standard Error|Least Squares Mean
775317|NCT00756002|Secondary|Subjective Sleep Quality, Per Post-sleep Questionnaire (Nights 1-2).|Sleep quality obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography. 7=Extremely Poor; 6=Very Poor; 5=Poor; 4=Fair; 3=Good; 2=Very Good; 1=Excellent.|Nights 1-2|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||scores on a scale||Standard Error|Least Squares Mean
775318|NCT00756002|Secondary|Sleep Efficiency, Per Polysomnography (Nights 29-30).|The Total Sleep Time was divided by the total time in bed (ie, the number of minutes from the beginning of the Polysomnography recording to the end of the recording), multiplied by 100.|Nights 29-30|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||percentage of time asleep to time in bed||Standard Error|Least Squares Mean
775319|NCT00756002|Secondary|Sleep Efficiency, Per Polysomnography (Nights 15-16).|The total sleep time was divided by the total time in bed (ie, the number of minutes from the beginning of the Polysomnography recording to the end of the recording), multiplied by 100.|Nights 15-16|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||percentage of time asleep to time in bed||Standard Error|Least Squares Mean
775320|NCT00756002|Secondary|Sleep Efficiency, Per Polysomnography (Nights 1-2).|The total sleep time was divided by the total time in bed (ie, the number of minutes from the beginning of the Polysomnography recording to the end of the recording), multiplied by 100.|Nights 1-2|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||percentage of time asleep to time in bed||Standard Error|Least Squares Mean
775321|NCT00756002|Secondary|Subjective Total Sleep Time, Per Post-sleep Questionnaire (Week 5).|Subjects answered a Post-Sleep Questionnaire via IVRS. The Subjective Total Sleep Time weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural “home” setting.|Week 5|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||minutes||Standard Error|Least Squares Mean
775461|NCT00757484|Primary|Percentage of Participants Who Underwent Gynecologic Surgery|491 women were included in analysis. Measure is categorized by the type of surgery.|January 2007 to January 2008|491 women were included in analysis.||percentage of participants|||Number
775462|NCT00757588|Other Pre-specified|Percentage of Participants With Reported and Confirmed Hypoglycemia|Confirmed hypoglycemia=fingerstick glucose measurement of ≤50 mg/dL with associated symptoms/|Baseline to Week 52|||Percentage of Participants|||Number
775322|NCT00756002|Secondary|Subjective Total Sleep Time, Per Post-sleep Questionnaire (Week 4).|Subjects answered a Post-Sleep Questionnaire via IVRS. The Subjective Total Sleep Time weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural “home” setting.|Week 4|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||minutes||Standard Error|Least Squares Mean
775323|NCT00756002|Secondary|Subjective Total Sleep Time, Per Post-sleep Questionnaire (Week 2).|Subjects answered a Post-Sleep Questionnaire via IVRS. The Subjective Total Sleep Time weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural “home” setting.|Week 2|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||minutes||Standard Error|Least Squares Mean
775324|NCT00756002|Secondary|Subjective Total Sleep Time, Per Post-sleep Questionnaire (Nights 29-30).|Subjects answered a Post-Sleep Questionnaire in the sleep lab the morning following overnight Polysomnography. Subjective Total Sleep Time measured the average of the 2 mornings after each overnight Polysomnography Visit.|Nights 29 -30|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||minutes||Standard Error|Least Squares Mean
775325|NCT00756002|Secondary|Subjective Total Sleep Time, Per Post-sleep Questionnaire (Nights 15-16).|Subjects answered a Post-Sleep Questionnaire in the sleep lab the morning following overnight Polysomnography. Subjective Total Sleep Time measured the average of the 2 mornings after each overnight Polysomnography Visit.|Nights 15-16|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||minutes||Standard Error|Least Squares Mean
775326|NCT00756002|Secondary|Subjective Total Sleep Time, Per Post-sleep Questionnaire (Nights 1-2).|Subjects answered a Post-Sleep Questionnaire in the sleep lab the morning following overnight Polysomnography. Subjective Total Sleep Time measured the average of the 2 mornings after each overnight Polysomnography Visit.|Nights 1-2|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||minutes||Standard Error|Least Squares Mean
775327|NCT00756002|Secondary|Total Sleep Time, Per Polysomnography (Nights 29-30).|All of the minutes of Stages 1, 2, 3/4 NREM and REM sleep, as measured by Polysomnography, are summed to determine the Total Sleep Time.|Nights 29-30|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||minutes||Standard Error|Least Squares Mean
775328|NCT00756002|Secondary|Total Sleep Time, Per Polysomnography (Nights 15-16).|All of the minutes of Stages 1, 2, 3/4 NREM and REM sleep, as measured by Polysomnography, are summed to determine the Total Sleep Time.|Nights 15-16|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||minutes||Standard Error|Least Squares Mean
775329|NCT00756002|Secondary|Total Sleep Time, Per Polysomnography (Nights 1-2).|All of the minutes of Stages 1, 2, 3/4 Non Rapid Eye-Movement (NREM) and Rapid-Eye-Movement (REM) sleep, as measured by Polysomnography, are summed to determine the Total Sleep Time.|Nights 1-2|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||minutes||Standard Error|Least Squares Mean
775330|NCT00756002|Secondary|Subjective Sleep Latency, Per Post-sleep Questionnaire (Week 5).|Subjects answered a post-sleep questionnaire via IVRS. The Subjective Sleep Latency weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural “home” setting.|Week 5|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||minutes||Standard Error|Least Squares Mean
775331|NCT00756002|Secondary|Subjective Sleep Latency, Per Post-sleep Questionnaire (Week 4).|Subjects answered a post-sleep questionnaire via IVRS. The Subjective Sleep Latency weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural “home” setting.|Week 4|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||minutes||Standard Error|Least Squares Mean
775332|NCT00756002|Secondary|Subjective Sleep Latency, Per Post-sleep Questionnaire (Week 2).|Subjects answered a post-sleep questionnaire via IVRS. The Subjective Sleep Latency weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural “home” setting.|Week 2|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||minutes||Standard Error|Least Squares Mean
775333|NCT00756002|Secondary|Subjective Sleep Latency, Per Post-sleep Questionnaire (Nights 29-30).|Subjective sleep latency was collected by subjects answering a post-sleep questionnaire (via IVRS) following an overnight Polysomnography in the sleep lab.|Nights 29-30|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||minutes||Standard Error|Least Squares Mean
775334|NCT00756002|Secondary|Subjective Sleep Latency, Per Post-sleep Questionnaire (Nights 15-16).|Subjective sleep latency was collected by subjects answering a post-sleep questionnaire (via IVRS) following an overnight Polysomnography in the sleep lab.|Nights 15-16|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||minutes||Standard Error|Least Squares Mean
775335|NCT00756002|Secondary|Subjective Sleep Latency, Per Post-sleep Questionnaire (Nights 1-2).|Subjective sleep latency was collected by subjects answering a post-sleep questionnaire via an interactive voice response system (IVRS) following an overnight Polysomnography in the sleep lab.|Nights 1-2|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||minutes||Standard Error|Least Squares Mean
775336|NCT00756002|Secondary|Mean Latency to Persistent Sleep Via Polysomnography (Nights 29-30).|Elapsed time from the beginning of the Polysomnography recording to the onset of the first 10 minutes of continuous sleep was measured.|Nights 29-30|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||minutes||Standard Error|Least Squares Mean
775337|NCT00756002|Secondary|Mean Latency to Persistent Sleep Via Polysomnography (Nights 15-16).|Elapsed time from the beginning of the Polysomnography recording to the onset of the first 10 minutes of continuous sleep was measured.|Nights 15-16|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||minutes||Standard Error|Least Squares Mean
775338|NCT00756002|Primary|Mean Latency to Persistent Sleep Via Polysomnography (Nights 1-2).|Elapsed time from the beginning of the Polysomnography recording to the onset of the first 10 minutes of continuous sleep was measured over 2 nights and the average time to sleep was calculated.|Nights 1-2|The Full Analysis Set (FAS) population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and Last Observation Carried Forward (LOCF) data.||minutes||Standard Error|Least Squares Mean
775339|NCT00756093|Primary|Drop Comfort|Drop comfort grading scale is a 0 to 9 scale, with 0 meaning most comfortable and 9 meaning most uncomfortable.|once upon instillation|||units on a scale||Standard Deviation|Mean
775340|NCT00756236|Primary|Area Under the Curve of etSEV Over the First Hour|We will measure the amount of Sevoflurane used to achieve the same level Bispectral Index. Each patient will have their percentage of sevoflurane in expired breath measured every 5 minutes for 2 hours, resulting in 24 data points per person. The primary endpoint will be area under the curve (AUC) for each subject for the first hour.|Every 5 minutes for 2 hours|||percent*hour||Standard Deviation|Mean
775341|NCT00756314|Secondary|Satisfaction With the Used Contraceptive Method|the satisfaction was measured according a scale ranging in 3 levels: very satisfied, somewhat satisfied and dissastisfied.|During the 6-month Follow-up|||participants|||Number
775342|NCT00756314|Primary|Chosen Contraceptive Method After Counseling|the type of contraceptive methods chosen by women following after counseling|after the contraceptive counseling|||participants|||Number
775343|NCT00756314|Secondary|Pregnancies Among All Women||within the first six months after intervention|||participants|||Number
775344|NCT00756314|Primary|Correct Use of the Method|the correct use was considerer by each methods according the prescription.|within the first 6 months after intervention|||participants|||Number
775345|NCT00756314|Primary|Contraceptive Acceptability and Use of Contraceptives During the 6-month Follow-up|"The acceptability and the use of contraceptives during the follow-up period was defined as just yes or no"|after the contraceptive counseling and during the 6-month follow|"The analysis was by intention to treat in both groups. All the women were retained in their original assigned group."||participants|Participants||Number
775346|NCT00756444|Primary|Steady-state Plasma Concentrations (Css) for 5-FU With and Without the Presence of Panitumumab|Steady-state plasma concentrations (Css) of 5-FU were estimated as the mean of two or more evaluable concentrations at 24, 72, and 96 hours after the start of 5-FU infusion. Css is estimated both for subjects receiving 5-FU with panitumumab and for subjects receiving 5-FU without panitumumab|24 to 96 hours following start of cycle 2 infusion with 5-FU|Subjects who receive at least 2 cycles of assigned treatment and who have sufficient plasma collection to derive Css||ng/mL||Standard Deviation|Mean
775347|NCT00756444|Primary|Area Under the Curve (AUC) of Total Plasma Cisplatin-derived Platinum Levels With and Without the Presence of Panitumumab|AUC refers to area under the concentration curve from time 0 to last measurable concentration. AUC of total plasma cisplatin-derived platinum levels is estimated both for subjects receiving cisplatin with panitumumab and for subjects receiving cisplatin without panitumumab.|Levels measured at 0.5, 1, 2, 3, 4, 6 and 24 hours following start of cycle 2 cisplatin infusion|Subjects who receive at least 2 cycles of assigned treatment and who have sufficient plasma collection to derive AUC||ng*hr/mL||Standard Deviation|Mean
775348|NCT00756457|Secondary|Foot Strength|A force transducer (Model SML-200, Interface, Scottsdale, AZ) was connected in series with a resistance plate and oscilloscope (TDS 410A, Tektronix, Beaverton, OR) to display force readings. Participants were seated with their leg in an an air stirrup brace (Aircast, Inc.) mounted on uprights. The air stirrup brace was adjusted so the heel was approximately 10 cm above the resistance plate, resulting in 30 to 45 degrees of ankle plantar flexion depending on foot length. The resistance plate was mounted on ball bearing tracks in the medial/lateral direction and moleskin was used to fit to the general shape of the medial forefoot. The result was that participants could exert maximum effort against the resistance plate (medial direction) with little discomfort. This testing position essentially replicates the manual muscle test position for the posterior tibialis muscle. Force in Newtons was then divided by body mass in kilograms to calculate normalized strength (N/Kg).|Measured at Weeks 1, 6, and 12|||N/kg||Standard Deviation|Mean
775858|NCT00754065|Secondary|Number of Days With Spotting-only in Reference Period 4|Reference Period 4 is defined as Day 271 to Day 360 during study treatment.|From Day 271 to Day 360|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
775349|NCT00756457|Primary|Short Musculoskeletal Functional Assessment|The Short Musculoskeletal Function Assessment Questionnaire (SMFA) is a 46 item self-report questionnaire consisting of the Dysfunction Index, which has thirty-four items, and the Bother index which has 12 items. The Dysfunction index is used for assessment of patient perceptions of functional performance while the Bother index is used to assess patients’ perceptions of the degree patients are bothered in broad areas such as recreation and leisure. The responsiveness to change of the SMFA is 10 points out a range of 100 for each scale (Dysfunction, Mobility, and Bother indexes). The SMFA is also particularly suitable for the current investigation due to the presence of a sub-category of questions from the Dysfunction Index that pertains specifically to mobility (i.e. Mobility Index). Lower scores (lowest = 0) indicate better function, mobility, and that patients are less bothered while higher scores (highest = 100) indicate worse function, mobility and that patients are bothered.|Measured at Weeks 1, 6, and 12|||score||Standard Deviation|Mean
775350|NCT00756457|Secondary|Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)|A 3 dimensional foot kinematic model including the tibia, calcaneus (hindfoot), 1st metatarsal, 2-4th metatarsals and hallux was used to measure foot movement. Six infrared cameras (Optotrak Motion Analysis System, Northern Digital Inc, CAN), synchronized with force plate data (Model 9286, Kistler, Switzerland), were used to collect kinematics (60 Hz) and force (1000 Hz) data with the Motion Monitor software Version 7.24 (Motion Monitor, Innsport Training Inc, USA). Anatomically based coordinate systems were established for each segment using digitized boney landmarks consistent with a previous study. Kinematic data were smoothed using a 4th order, zero phase lag, Butterworth filter with a cut off frequency of 6 Hz. To calculate relative joint angles a Cardan angle Z-X-Y sequence of rotations was used as suggested by Cole et al. The range of possible values varies for each individual and each joint.|Measured at Weeks 1,6 and 12|||Degrees||Standard Deviation|Mean
775351|NCT00756457|Primary|Foot Function Index(FFI)|The Foot Function Index (FFI) is a validated disease specific questionnaire that has been used to document outcomes in uncontrolled studies of PTTD. The domains of the 23 item FFI questionnaire include pain, disability, and activity limitations. The scale was originally validated in subjects with foot problems related to rheumatoid arthritis patients, and has subsequently been used to measure outcomes for a variety of foot and ankle problems including plantar fasciitis, diabetes, and PTTD. In clinical trials, the FFI has been used to detect change attributable to orthotics, plantar fasciitis, and brace use in PTTD. The three domains of the FFI include pain (FFI-Pain) range 0 to 90, disability (FFI-Disability) range 0- 90, and activity limitations (FFI-Activity Limitations) range 0 to 50. Each category asks patients to rate items relative to pain with higher scores indicating greater pain. The average of the three scales is the FFI-Total.|Measured at Weeks 1, 6, and 12|A power analysis was performed based on previous a previous study. Only the participants that completed the study are included in the analysis. One participant opted to have surgery at 2 weeks from the Brace & Exercise group. One participant moved overseas and the other resumed cancer treatments bringing the total to 17.||units on a scale||Standard Deviation|Mean
775352|NCT00756470|Primary|Rate of Pathologic Complete Response (pCR) Following Neoadjuvant Chemotherapy|Pathologic complete response (pCR) rate defined as number of participants out of total that had no residual invasive disease (malignant cells) in the breast or axillary lymph nodes as assessed at the time of surgery following completion of all protocol specified neoadjuvant chemotherapy, which is approximately 26 weeks following the start of neoadjuvant chemotherapy.|Assessed at time of surgery following completion neoadjuvant chemotherapy (approximately 26 weeks)|With an intent-to-treat population analysis, all participants who received any treatment were included in the analyses.||Percentage of Participants|||Number
775353|NCT00756470|Secondary|Number of Participants With pCR After Completion of All Protocol Specified Therapy & Surgery (Surgical Population)|Pathologic complete response [pCR or RCB Class 0] defined as no residual invasive disease (malignant cells) in the breast or axillary lymph nodes as assessed at the time of surgery following completion of all protocol specified neoadjuvant chemotherapy, which is approximately 26 weeks following the start of neoadjuvant chemotherapy and surgery. the residual cancer burden (RCB) was estimated from routine pathologic sections of the primary breast tumor site and the regional lymph nodes. The calculated RCB index value is categorized as one of four RCB classes, RCB-0 to RCB-III where RCB-0 is best prognosis (no residual disease) to RCB-III a worst prognosis. The RCB score for participants was assessed following completion of all protocol specified therapy, 4 cycles of lapatinib and paclitaxel followed by 4 cycles of lapatinib plus FEC75 and surgery.|Following definitive surgery at completion of neoadjuvant chemotherapy (following approximately 26 treatment weeks)|While analyses was based on intent-to-treat (ITT) the surgical population includes only subjects who underwent definitive surgery (10 participants had a modified radical mastectomy) thus 5 were not evaluable for this outcome.||participants|||Number
775354|NCT00756548|Secondary|Serum Chemistry Results (Osmolality)|Change from Baseline|2 days|||mOsm/kg||Standard Deviation|Mean
775355|NCT00756548|Secondary|Hematology Results - Red Blood Cells|Change from Baseline|2 days|||million/microliter||Standard Deviation|Mean
775356|NCT00756548|Secondary|Hematology Results (1000/MCL)|Change from Baseline|2 days|||1000/MCL||Standard Deviation|Mean
775357|NCT00756548|Secondary|Hematology Results - Hemoglobin|Change from Baseline|2 days|||g/dL||Standard Deviation|Mean
775358|NCT00756548|Secondary|Serum Chemistry Results - Glomerular Filtration Rate|Change from Baseline|2 days|||ml/min||Standard Deviation|Mean
775359|NCT00756548|Secondary|Serum Chemistry Results (g/dL)|Change from Baseline|2 days|||g/dL||Standard Deviation|Mean
775360|NCT00756548|Secondary|Serum Chemistry Results (mg/dL)|Change from Baseline|2 days|||mg/dL||Standard Deviation|Mean
775361|NCT00756548|Secondary|Serum Chemistry Results (U/L)|Change from Baseline|2 days|||U/L||Standard Deviation|Mean
775362|NCT00756548|Secondary|Hematology Results (%)|Change from Baseline|2 days|Intent to treat population||Percentage of cells||Standard Deviation|Mean
775363|NCT00756548|Secondary|Serum Chemistry Results (mEq/L)|Change from Baseline|2 days|||milliequivalent/L||Standard Deviation|Mean
775364|NCT00756548|Primary|Efficacy - Preparation Quality Using a 4 Point Scale|"Percentage of patients with a successful preparation (cleaning rated as Good or Excellent)"|2 days|186 patients were included in the BLI850 intent-to-treat population. One patient took the preparation but did not undergo colonoscopy due to insurance coverage issues. This patient is excluded from all efficacy analyses.||percentage of participants||95% Confidence Interval|Number
775370|NCT00756678|Secondary|Number of Patients With Positive Responses to Subject Preference Questionnaire on Day 16|Number of patients who marked that either Week 1 study product was more soothing or Week 2 study product was more soothing to the Overall Comfort Preference Questionnaire on Day 16 of the cross-over period. The Subject Preference Questionnaire consists of 4 questions related to comfort, soothing, blurring and purchase preference comparing treatments received during Week 1 versus Week 2.|Day 16|Intent to Treat; defined as all randomized (started study) patients.||Number of patients|||Number
775371|NCT00756678|Secondary|Percentage of Positive Patient Responses to Subject Acceptability Questionnaire on Day 16|"Percentage of patients who responded Strongly Agree and Agree to Subject Acceptability Questionnaire Question 1: Overall Liked. The Subject Acceptability Questionnaire consists of 11 multiple choice questions assessing how the patients feel about the eye drops received. The 5 possible responses to the questionnaire are Strongly Agree, Agree, Neither Agree or Disagree, Disagree and Strongly Disagree."|Day 16|Intent to treat; defined as all randomized (started study)patients. Of the 51 randomized patients, data for 50 patients were evaluated for this outcome measure||Percentage of Patients|||Number
775372|NCT00756678|Secondary|Change From Baseline in Dry Eye Disease Comfort Assessment Score on Day 16|Mean change from baseline in Dry Eye Disease Comfort Assessment Score at Day 16. The Dry Eye Disease Comfort Assessment consists of one question asking the patient to rate their current overall discomfort from their dry eye symptoms on a scale of 0 to 10 (0 equals No Discomfort; 10 equals Intolerable). The greater the negative number change from baseline, the greater the improvement in comfort.|Baseline, Day 16|Intent to Treat; defined as all randomized (started study) patients. Of the 51 randomized patients, data from 49 patients were evaluated for this outcome measure.||Scores on a scale||Standard Deviation|Mean
775373|NCT00756678|Primary|Mean Frequency of Eye Drop Use Over 1 Week|Mean frequency of eye drop use per day per patient during the cross-over period over 1 week. Eye drop use was captured on a daily tear diary that the patients completed. The greater the frequency of use, the more eye drops were required to manage the patient's dry eye symptoms.|1 week|Intent to Treat; defined as all randomized (started study) patients. Of the 51 patients that were randomized, data for 50 patients were evaluated for this outcome measure||Use per day||Standard Deviation|Mean
775374|NCT00750360|Secondary|Number of Participants Reporting Serious Adverse Events (SAE).|"An SAE is any untoward medical occurrence that:
results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above."|Within 1 month following vaccination|||participants|||Number
775375|NCT00750360|Secondary|Number of Participant Reporting Unsolicited Adverse Events.|An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|During the 21-day follow-up period (Day 0 to Day 20) after vaccination|||participants|||Number
775376|NCT00750360|Secondary|Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older.|Solicited local adverse events assessed include induration, pain, redness, and swelling. Solicited general adverse events assessed include fatigue, fever, shivering, malaise, myalgia, headache, and sweating/diaphoresis.|During the 4-day follow up (Day 0 to 3) after vaccination.|||participants|||Number
775377|NCT00750360|Secondary|Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged Less Than 72 Months.|Solicited local adverse events assessed include induration, pain, redness, and swelling. Solicited general adverse events assessed include fever, shivering, and sweating/diaphoresis.|During the 4-day follow up (Day 0 to 3) after vaccination.|||participants|||Number
775378|NCT00750360|Primary|Number of Participants Reporting Severe Unsolicited Adverse Events|"An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Severe unsolicited adverse events are defined as adverse events which prevent normal, everyday activities"|During the 21-day follow-up period (Day 0 to Day 20) after vaccination|||participants|||Number
775379|NCT00750373|Secondary|Readmission Due to Development of Congestive Heart Failure||up to 6 months after enrollment||||||
775380|NCT00750373|Secondary|All Embolic Events Including Symptomatic and Asymptomatic Embolization Documented by Imaging Studies||up to 6 months after enrollment||||||
775381|NCT00750373|Secondary|Recurrences of Infective Endocarditis||up to 6 months after enrollment||||||
775382|NCT00750373|Secondary|All-cause Death||up to 6 month after enrollment||||||
775383|NCT00750373|Primary|Number of Participants With In-hospital Death or Clinical Embolic Events|The composite of in-hospital death and clinical embolic events confirmed by imaging studies: the acute onset of clinical symptoms or signs of embolism and the occurrences of new lesions, as confirmed by follow-up imaging studies.|within 6 weeks from the randomization|intention to treat analysis||participants|||Number
775384|NCT00750737|Secondary|Efficacy Outcome Measured as Success or Failure|Success: Defined as the absence of proven or probable invasive fungal infection through the end of prophylaxis and absence of Grade 1-4 toxicity related to prophylaxis requiring the discontinuation of the drug. Failure: Presence of proven or probable fungal infection or development of Grade 1-4 toxicity related to prophylaxis while on study drug and requiring discontinuation of study drug or inability to tolerate intravenous ABLC (due to infusion related toxicities) or oral Posaconazole (due to mucositis or vomiting).|Day 1 through Day 42|Out of 46 participants, 40 were included in the analysis and 6 withdrew consent.||percentage of participants|||Number
775385|NCT00750737|Primary|Incidence of Invasive Fungal Infection (IFI)|Percentage of participants that developed IFI within 7 days of antifungal prophylaxis therapy (Posaconazole or ABLC).|Within 7 days of antifungal prophylaxis therapy|Out of 46 participants, 40 were included in the analysis and 6 withdrew consent.||percentage of participants|||Number
775386|NCT00750815|Secondary|Phase II: Two Year Overall Survival (OS)|Overall survival by disease risk stratification after CVDD. OS: time from initiation of therapy until death from any cause.|2 years|Participants with cytogenetics and fluorescence in situ hybridisation (FISH) results available for risk stratification.||percentage of participants||95% Confidence Interval|Number
775859|NCT00754065|Secondary|Number of Days With Spotting-only in Reference Period 3|Reference Period 3 is defined as Day 181 to Day 270 during study treatment.|From Day 181 to Day 270|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
775387|NCT00750815|Secondary|Phase II: Progression-Free Survival (PFS)|"Progression-free survival after CVDD in participants with newly diagnosed active multiple myeloma. PFS: time from the initiation of therapy to progression, relapse or death from any causes.
Progressive Disease (PD): Progressive Disease requires any one or more of the following:
Increase of ≥ 25% from baseline in:
serum M-component and /or (the absolute increase must be ≥ 0.5 g/dL)
urine M-component and/or (the absolute increase must be ≥ 200 mg/24 h)"|Up to 50.9 months|||months||95% Confidence Interval|Median
775388|NCT00750815|Primary|Phase II: Overall Response Rate (ORR)|Best response to CVDD chemotherapy. Overall Response: Partial Response (PR) + Very Good Partial Response (VGPR) + Complete Response (CR). PR: ≥ 50% reduction of serum M-protein and reduction in 24 hour urinary M-protein by ≥ 90% or to < 200 mg per 24 hours; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein with urine M-protein level < 100 mg per 24 hours; CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and ≤ 5% plasma cells in bone marrow.|Up to 6 months|All Participants with Partial Response, Very Good Partial Response, or Complete Response.||participants|||Number
775389|NCT00750815|Primary|Phase I - Maximum Planned Dose (MPD) Level|"Maximum Phase II planned dose of cyclophosphamide when given in combination with bortezomib, pegylated liposomal doxorubicin and Dexamethasone (CVDD) in participants with newly diagnosed active multiple myeloma. Dose levels 1, 2, 3, 4 as outlined in Treatment Arm A.
If no dose limiting toxicity (DLT) was reported in the first 3 participants at a dose level, that dose level was to be considered safe and 3 participants would be enrolled at the next dose level. If 1/3 participants in a cohort at a dose level had dose limiting toxicity (DLT), the dose level would be expanded to obtain 6 evaluable participants. MPD reflects the highest dose of drug that did not cause a DLT in 33% of participants."|9 months|All participants in Arm A. Three participants at each dose level.||Dosing Level|||Number
775390|NCT00750867|Secondary|Preliminary Efficacy of IVIg for Treatment of MSA.|The secondary outcome measure was to evaluate the preliminary efficacy of IVIG for the treatment of MSA. The primary efficacy endpoint was change of the Unified MSA Rating Scale (UMSARS-I and UMSAR-II) compared to baseline. UMSARS-I and UMSARS-II are validated semiquantitative rating scales for evaluation of severity of MSA. UMSARS-I comprises a historical review of disease-related impairments and UMSARS-II comprises motor examination. UMSARS-I has 12 questions, each with assigned score 0-4, where 0 is normal and > are abnormal responses. Total range of UMSARS-I is 0 to 48. UMSARS-II has 12 items rated by an examiner, each with assigned score 0-4, where 0 is normal and > are abnormal responses. Total range of UMSARS-II is 0 to 56. The scores of UMSARS-I and UMSARS-II at baseline (month 1) was compared with the scores obtained at the final visit (month 8) which was 8 months apart. The interventions occured at months 2-7, total six times.|Monthly, up to 8 months (including the screening visit and the final visit)|||units on a scale||Standard Deviation|Mean
775391|NCT00750867|Primary|Number of Adverse Events up to Six Months Post-treatment|The primary outcome measure was to evaluate the safety and tolerability of the IVIG infusions in patients with multiple system atrophy. The primary endpoint was defined as the frequency of adverse events (AE). AEs including their severity and relationship to the IVIG were assessed throughout the study and at least 60 days after the last infusion. The AEs were considered to be related to the IVIG infusion (infusional AE) if they occurred during an infusion or within 72 hours afterwards. Non-infusional AEs were further classified as possible related to IVIG or likely not related to IVIG. Serious AEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization. Any AE was defined as occurrence of any symptom regardless of intensity grade.|Monthly, up to 8 months (including the screening visit and the final visit)|Two participants dropped out from the study.||Adverse events|||Number
775392|NCT00750880|Secondary|Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score by Visit|FACIT-Fatigue is a 13-item questionnaire; participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the participant's health status.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.||units on a scale||Standard Deviation|Mean
775393|NCT00750880|Secondary|Percentage of Participants With HAQ-DI Clinical Remission and Clinically Meaningful Improvement By Visit|The HAQ-DI scale ranges from 0 to 3, where higher scores represent higher disease activity. A score of <0.5 represents clinical remission. A participant achieves a clinically meaningful improvement in HAQ-DI if they had a reduction from baseline of ≥0.22.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
775394|NCT00750880|Primary|Percentage of Participants With Adverse Events (AEs): Overall Summary|Percentage of participants with AEs, serious AEs (SAEs), related AEs, related SAEs, severe AEs, with AEs leading to withdrawal or dose modification, with infection, serious infection, infusion reactions, infusion reactions during an infusion, infusion reactions within 24 hours of an infusion, major adverse cardiac event (MACE), or death.|Weeks 4, 8, 12, 16, 20, and 24|Safety population: all participants included in the study who received at least 1 dose of study medication and who had at least 1 postbaseline assessment of safety (post-baseline laboratory data, vital signs, or adverse events). number (n) equals (=) number of participants analyzed for the parameter within the specific population.||percentage of participants|||Number
775395|NCT00750880|Secondary|Short Form-36 (SF-36) Physical Functioning Domain Scores by Visit|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of >3 points were considered clinically meaningful.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.||units on a scale||Standard Deviation|Mean
775511|NCT00757783|Secondary|Number of Participants With Antiviral Activity, HIV-1 RNA, Missing Values as Treatment Failure (M=F)|Number of participants with antiviral activity, HIV-1 RNA, missing values as treatment failure (Missing = Failure) were observed.|Week 12 and 48|The ITT population included participants who remained on study through Week 48 and had an assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit.||number of participants|||Number
775396|NCT00750880|Secondary|HAQ-DI Scores by Visit|HAQ-DI includes 20 questions concerning participant’s activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant’s everyday activities: 0 (equals)=without difficulties; 1=with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.||units on a scale||Standard Deviation|Mean
775397|NCT00750880|Secondary|Erythrocyte Sedimentation Rate by Visit|ESR (mm/hr) is a blood test used to monitor therapy in inflammatory diseases such as rheumatoid arthritis (RA) and reflects acute phase reactant levels. Active disease in RA is defined by an ESR greater than 30 mm/hr. Change from baseline is computed as the value at each week minus the baseline value. A negative value in change from baseline indicates an improvement.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.||mm/hr||Standard Deviation|Mean
775398|NCT00750880|Secondary|C-Reactive Protein by Visit|The test for CRP (mg per deciliter [mg/dL]) is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.||mg/dL||Standard Deviation|Mean
775399|NCT00750880|Secondary|Patient's Global Assessment of Pain by Visit|The participants assessed their pain using a 0 to 100 mm horizontal VAS. The left-hand extreme of the line=0 mm, and is described as “no pain” and the right-hand extreme=100 mm as “unbearable pain”. The participant marked the line and the distance from the left edge was recorded. A negative change from baseline indicated improvement.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.||mm||Standard Deviation|Mean
775400|NCT00750880|Secondary|Physician's Global Assessment of Disease Activity by Visit|The physician’s global assessment of disease activity is assessed on a 0 to 100 mm horizontal VAS by the physician. The left-hand extreme of the line=0 mm, and is described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme=100 mm as “maximum disease activity” (maximum arthritis disease activity). The physician marked the line and the distance from the left edge was recorded. A negative change from baseline indicated improvement.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.||mm||Standard Deviation|Mean
775401|NCT00750880|Secondary|Patient's Global Assessment of Disease Activity by Visit|The participant's global assessment of disease activity is assessed on a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line=0 mm, and is described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme=100 mm, as “maximum disease activity” (maximum arthritis disease activity). The line was marked by the participant and the distance from the left edge was recorded. A negative change from baseline indicated improvement.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.||mm||Standard Deviation|Mean
775402|NCT00750880|Secondary|Tender Joint Count by Visit|Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1; total was calculated by adding all the joints for a maximum score of 68. A negative change from baseline indicates improvement.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; missing data were handled using the last observation carried forward (LOCF) approach.||tender joints||Standard Deviation|Mean
775403|NCT00750880|Secondary|Swollen Joint Count by Visit|Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1; total was calculated by adding all the joints for a maximum score of 66. A negative change from baseline indicates improvement.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; missing data were handled using the LOCF approach.||swollen joints||Standard Deviation|Mean
775404|NCT00750880|Secondary|Time to Achieve ACR20, ACR50, ACR70 and ACR90 Response|ACR20, ACR50, ACR70, and ACR90 are defined as ≥20%, ≥50%, ≥70%, or ≥90% improvement, respectively, in: swollen joint count (SJC; 66 joints) and tender joint count (TJC; 68 joints) and ≥20%, ≥50%, ≥70%, or ≥90% improvement, respectively, in 3 of following 5 assessments: Patient's Global Assessment of Pain (VAS); Patient's Global Assessment of Disease Activity (VAS); Investigator/Physician’s Global Assessment of Disease Activity (VAS); participant’s assessment of disability measured by the HAQ-DI; or acute phase reactant (ESR or CRP). Time to ACR response was calculated as the number of days from day 1 of study to the date of first achievement of ACR response. Data represent median time for responders only.|Weeks 4, 8, 12, 16, 20, and 24|ITT population; only participants with a response (ACR20/ACR50/ACR70/ACR90) were included in the analysis. n=number of participants with a response for the specified parameter||days||95% Confidence Interval|Median
775405|NCT00750880|Secondary|Time to Achieve ACR20, ACR50, ACR70 and ACR90 Response - Number of Participants With an Event|ACR20, ACR50, ACR70, and ACR90 are defined as ≥20%, ≥50%, ≥70%, or ≥90% improvement, respectively, in: swollen joint count (SJC; 66 joints) and tender joint count (TJC; 68 joints) and ≥20%, ≥50%, ≥70%, or ≥90% improvement, respectively, in 3 of following 5 assessments: Patient's Global Assessment of Pain (VAS); Patient's Global Assessment of Disease Activity (VAS); Investigator/Physician’s Global Assessment of Disease Activity (VAS); participant’s assessment of disability measured by the HAQ-DI; or acute phase reactant (ESR or CRP).|Weeks 4, 8, 12, 16, 20, and 24|ITT population||participants|||Number
775416|NCT00750893|Primary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31 day follow-up period after each vaccine dose for Year 1 to Year 6 study period|Analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects with at least one dose of Rotarix™ vaccine administration documented.||Subjects|||Number
775406|NCT00750880|Secondary|Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%), 50%, 70%, or 90% Improvement (ACR20/ACR50/ACR70/ACR90) by Visit|ACR20, ACR50, ACR70, and ACR90 are defined as ≥20%, ≥50%, ≥70%, or ≥90% improvement, respectively, in: swollen joint count (SJC; 66 joints) and tender joint count (TJC; 68 joints) and ≥20%, ≥50%, ≥70%, or ≥90% improvement, respectively, in 3 of following 5 assessments: Patient's Global Assessment of Pain (visual analog scale [VAS]); Patient's Global Assessment of Disease Activity (VAS); Investigator/Physician’s Global Assessment of Disease Activity (VAS); participant’s assessment of disability measured by the Health Assessment Questionnaire Disability Index (HAQ-DI); or acute phase reactant (ESR or C-reactive protein [CRP]). Participants who did not have the required data to assess ACR status at a given visit were classified as non-responders.|Weeks 4, 8, 12, 16, 20, and 24|ITT population||percentage of participants|||Number
775407|NCT00750880|Secondary|DAS28 Scores by Visit|DAS28 calculated from the number of swollen joints and tender joints using the 28 joints count, the ESR (mm/hr) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. A negative change from baseline indicates improvement.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.||units on a scale||Standard Deviation|Mean
775408|NCT00750880|Secondary|Percentage of Participants Achieving a Response by European League Against Rheumatism (EULAR) Response Category and Visit|DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 ≤3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to ≤5.1 or change from baseline >0.6 to =<1.2 with DAS28 ≤5.1; non-responders: change from baseline ≤0.6 or change from baseline >0.6 and ≤1.2 with DAS28 >5.1. If the EULAR response could not be determined, it was set to 'No response'.|Weeks 4, 8, 12, 16, 20, and 24|ITT population||percentage of participants|||Number
775409|NCT00750880|Secondary|Time to Low Disease Activity and Remission Based on DAS28 Score - Time to Event|The time to low disease activity or remission was calculated as the number of days from study Day 1 to the first occurrence of low disease activity or remission. Participants who did not achieve low disease activity on or before Week 24 or who withdrew from the study prior to achieving low disease activity were considered censored. DAS28 calculated from the number of swollen joints and tender joints using the 28 joints count, the ESR (mm/hr) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. Low disease activity defined as DAS28 ≤3.2 and remission defined as DAS28 <2.6.|Baseline,Weeks 4, 8, 12, 16, 20, and 24|ITT population with DAS28 ≤3.2||days||Full Range|Median
775410|NCT00750880|Secondary|Time to Low Disease Activity or Remission Based on DAS28 - Number of Participants With an Event|DAS28 calculated from the number of swollen joints and tender joints using the 28 joints count, the ESR (mm/hr) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. Low disease activity was defined as DAS28 ≤3.2 and remission was defined as DAS28 <2.6.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; Only population with complete DAS28 data were analyzed.||participants|||Number
775411|NCT00750880|Secondary|Percentage of Participants Who Achieved Low Disease Activity or Remission Based on Disease Activity Score Based on 28-Joints Count (DAS28) by Visit|DAS28 calculated from the number of swollen joints and tender joints using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. Low disease activity was defined as DAS28 less than or equal to (≤)3.2 and remission was defined as DAS28 less than (<)2.6.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; no imputation of missing data was performed for this analysis.||percentage of participants|||Number
775412|NCT00750893|Primary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the post marketing study period for Year 1 to Year 6 study period|Analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects with at least one dose of Rotarix™ vaccine administration documented.||Subjects|||Number
775413|NCT00750893|Primary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the post marketing study period for Year 5 study period|Analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects with at least one dose of Rotarix™ vaccine administration documented.||Subjects|||Number
775414|NCT00750893|Primary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the post marketing study period for Year 3 & Year 4 study period|Analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects with at least one dose of Rotarix™ vaccine administration documented.||subjects|||Number
775415|NCT00750893|Primary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the post marketing study period for Year 1 & Year 2 study period|Analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects with at least one dose of Rotarix™ vaccine administration documented.||subjects|||Number
775447|NCT00756977|Secondary|Hematology Results (1000/MCL)|Change from Baseline|2 days|Intent to treat population||1000/MCL||Standard Deviation|Mean
775448|NCT00756977|Secondary|Serum Chemistry Results (GFR)|Change from Baseline|2 days|||ml/min||Standard Deviation|Mean
775417|NCT00750893|Primary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31 day follow-up period after each vaccine dose for Year 5 study period|Analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects with at least one dose of Rotarix™ vaccine administration documented.||Subjects|||Number
775418|NCT00750893|Primary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31 day follow-up period after each vaccine dose for Year 3 & Year 4 study period|Analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects with at least one dose of Rotarix™ vaccine administration documented.||subjects|||Number
775419|NCT00750893|Primary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31 day follow-up period after each vaccine dose for Year 1 & Year 2 study period|Analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects with at least one dose of Rotarix™ vaccine administration documented.||subjects|||Number
775420|NCT00750893|Primary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed include cough, diarrhoea, irritability, loss of appetite, temperature and vomiting.|During the 8 day follow-up period after each vaccine dose for Year 1 & Year 2 study period|Analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects with at least one dose of Rotarix™ vaccine administration documented.||subjects|||Number
775421|NCT00750919|Primary|Number of Participants Discontinuing Due to AEs|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.|Up to 26 weeks|The AST population consisted of all participants who received at least one dose of esmertazapine in the extension study.||Participants|||Number
775422|NCT00750919|Primary|Number of Participants Experiencing Adverse Events (AEs)|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.|Up to 30 weeks|The AST population consisted of all participants who received at least one dose of esmertazapine in the extension study.||Participants|||Number
775423|NCT00750919|Secondary|Change From Baseline in Wake Time After Sleep Onset (WASO)|"WASO was defined as the time recorded for sleep diary question 5 how much time were you awake, after falling asleep initially as reported by the participants using a LogPad (hand-held electronic data capture device). Baseline was defined as the WASO from the last week of the base study. Daily diary data were converted to weekly averages. For each treatment week the non-missing diary data of that week were taken into account; if a treatment week had three non-missing morning diaries or less, the data of the previous week were taken into account, weighing the data of both weeks, using the number of observed diaries as weights (weighted mean); if no diary data were available for a treatment week the data were considered as missing and were not imputed."|Baseline and Week 26|The AST population consisted of all participants who received at least one dose of esmertazapine in the extension study.||Minutes per night||Standard Deviation|Mean
775424|NCT00750919|Secondary|Change From Baseline in Sleep Latency (SL)|"SL was defined as the time recorded for sleep diary question 3 how long did it take you to fall asleep’,  as reported by the participants using a LogPad (hand-held electronic data capture device). Baseline was defined as the SL from the last week of the base study. Daily diary data were converted to weekly averages. For each treatment week the non-missing diary data of that week were taken into account; if a treatment week had three non-missing morning diaries or less, the data of the previous week were taken into account, weighing the data of both weeks, using the number of observed diaries as weights (weighted mean); if no diary data were available for a treatment week the data were considered as missing and were not imputed."|Baseline and Week 26|The All-Subjects-Treated (AST) population consisted of all participants who received at least one dose of esmertazapine in the extension study.||Minutes per night||Standard Deviation|Mean
775425|NCT00750919|Primary|Change From Baseline in Total Sleep Time (TST)|"TST was defined as the time recorded for sleep diary question 6 how much time did you actually spend sleeping as reported by the participants using a LogPad (hand-held electronic data capture device). Baseline was defined as the TST from the last week of the base study. Daily diary data were converted to weekly averages. For each treatment week the non-missing diary data of that week were taken into account; if a treatment week had three non-missing morning diaries or less, the data of the previous week were taken into account, weighing the data of both weeks, using the number of observed diaries as weights (weighted mean); if no diary data were available for a treatment week the data were considered as missing and were not imputed."|Baseline and Week 26|The All-Subjects-Treated (AST) population consisted of all participants who received at least one dose of esmertazapine in the extension study.||Minutes per night||Standard Deviation|Mean
775426|NCT00751036|Secondary|Overall Survival (OS)|. OS is defined as the time from the date of randomization to the date of death due to any cause or the date of last contact prior to or on the date of data cutoff. The median time to overall survival and its associated 95 % CI will be derived, for each treatment arm, using the time to event analysis based on Kaplan-Meier methodology.|time from the date of randomization to the date of death due to any cause or the date of last contact prior to or on the date of data cutoff, assesed until 24 months.|Full analysis set (FAS): consisted of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment to which they were assigned at randomization.||Days||95% Confidence Interval|Median
775427|NCT00751036|Secondary|Time to Treatment Failure|TTF, defined as the time from date of randomization to the earliest of date of the first objective tumor progression, date of death due to any cause, or date of discontinuation due to reasons other than ‘Protocol deviation’ or ‘Administrative problems’.|Time from date of radomization to the earliest date of the first objective tumor, death or discontinuation, assesed until 24 months.|Full analysis set (FAS): consisted of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment to which they were assigned at randomization.||Days||95% Confidence Interval|Median
775428|NCT00751036|Secondary|Disease Control Rate (DCR)|The Disease Control Rate (Complete Response(CR), Partial Response (PD) and Stable Disease (SD) rates for each treatment arm will be computed using the exact Clopper-Pearson interval estimation methodology. DCR is defined as the percentage of patients with a best overall response of • CR, i.e. at least two determinations of CR at least 4 weeks apart without loss of response between the determinations, • PR, i.e. at least two determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR) and without loss of PR between the determinations, or • SD lasting at least 24 weeks, i.e. at least one SD or better response at least 24 weeks after randomization (and not qualifying for CR or PR).|every 2 months until 24 months (end of study)|Full analysis set (FAS): consisted of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment to which they were assigned at randomization.||Percentage of Patients||95% Confidence Interval|Number
775429|NCT00751036|Primary|Progression-free Survival (PFS)|Progression-free survival (PFS) is the time from date of randomization to the date of first documented progression or death due to any cause. If a participant has not had an event, progression-free survival is censored at the time of last adequate tumor assessment. Progression is defined according to modified RECIST criteria as at least a 20% increase in the sum of the longest diameter of target lesions, worsening of the non-target lesions or the appearance of one or more new lesions.|24 months|Full Analysis Set (FAS) consisted of all randomized patients. Following the intent to treat principle, patients were analyzed according to the treatment which they were assigned at randomization.||Days||95% Confidence Interval|Median
775430|NCT00756730|Primary|The Change in Fasting Triglyceride Level From Baseline to Week 24||Baseline to week 24|Two patients in the ATV/r arm discontinued prior to week 24: 1 due to a grade 2 rash, and one due to low level viremia.||mg/dL||Full Range|Mean
775431|NCT00756730|Primary|At Week 24 the Percentage of Subjects That Had Triglycerides Less Than 200 mg/dL||24 weeks|Two patients in the ATV/r arm discontinued prior to week 24: 1 due to a grade 2 rash, and one due to low level viremia.||percentage of participants|||Number
775432|NCT00756730|Secondary|HDL Cholesterol at Week 24||24 weeks|Two patients in the ATV/r arm discontinued prior to week 24: 1 due to a grade 2 rash, and one due to low level viremia.||mg/dL||Full Range|Mean
775433|NCT00756730|Secondary|LDL Cholesterol at Week 24||week 24|Two patients in the ATV/r arm discontinued prior to week 24: 1 due to a grade 2 rash, and one due to low level viremia.||mg/dL||Full Range|Mean
775434|NCT00756730|Secondary|Total Cholesterol in the Two Study Groups at 24 Weeks||Week 24|Two patients in the ATV/r arm discontinued prior to week 24: 1 due to a grade 2 rash, and one due to low level viremia.||mg/dL||Full Range|Mean
775435|NCT00756730|Secondary|Difference in CD4 From Baseline to Week 24||baseline to Week 24|Two patients in the ATV/r arm discontinued prior to week 24: 1 due to a grade 2 rash, and one due to low level viremia.||cells/mm^3||Standard Error|Mean
775436|NCT00756730|Secondary|Percent of Patients With HIV VL <200 Copies/mL at Week 4, 12 & 24||Week 4, 12 & 24|||percentage of participants|||Number
775437|NCT00756730|Primary|Percentage of Patients That Experience 10% Decline in Triglycerides From Baseline to Week 24.|A 10% decline in triglycerides (TGs) was determined to be clinically significant. The percentage of people that experienced a 10% decline was calculated by dividing the number who had a decline of 10% TGs by the total number of participants in the arm.|baseline, 24 weeks|Two patients in the ATV/r arm discontinued prior to week 24: 1 due to a grade 2 rash, and one due to low level viremia. Neither subject met criteria for virologic failure.||percentage of patients|||Number
775438|NCT00756886|Primary|Atrial Fibrillation||0-21 days post-operative|||participants|||Number
775443|NCT00756964|Primary|Number of Patients With Acute Kidney Injury (AKI).|Acute kidney injury will be defined as an increase in serum creatinine of 0.3mg/dL from baseline or a 50% increase in serum creatinine from baseline values within 48 hours after surgery.|Within 48 hours postoperatively|As no similar study has been performed, a power analysis could not be performed. As such, we decided to do a pilot study with 26 subjects and to set criteria to maximize the likelihood of seeing an effect.||Participants|||Number
775444|NCT00756977|Secondary|Serum Chemistry Results (Osmolality)|Change from Baseline|2 days|||mOsm/kg||Standard Deviation|Mean
775445|NCT00756977|Secondary|Hematology Results - Red Blood Cells|Change from Baseline|2 days|||MILL/MCL||Standard Deviation|Mean
775446|NCT00756977|Secondary|Hematology Results - Hemoglobin|Change from Baseline|2 days|||g/dL||Standard Deviation|Mean
775463|NCT00757588|Other Pre-specified|Number of Participants With Marked Laboratory Abnormalities During the 24-Week ST + 52-Week LT Treatment Period|"Marked abnormality=a laboratory value lying outside the predefined criteria and more extreme (farther from the limit)on-treatment than at baseline. ULN=upper limit of normal; LLN=lower limit of normal; prx=pre-RX=pretreatment.
Criteria 1: if prx=0 use >=2, if prx=0.5 or 1 use >=3, if prx=2 use 4."|Baseline and during and up to 14 days after last dose of study drug (in Week 52)|All participants who received at least 1 dose of double-blind study medication.||Participants|||Number
775464|NCT00757588|Other Pre-specified|Shift in Platelet Counts From Baseline to Selected Visits (LOCF)|Platelet count=value*10^9 c/L|Baseline and Weeks 24 and 52|All participants who received at least 1 dose of double-blind study medication.||Participants|||Number
775465|NCT00757588|Other Pre-specified|Mean Changes From Baseline in Heart Rate||Baseline to Weeks 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, 44, and 52|All participants who received at least 1 dose of double-blind study medication.||Beats per minute||95% Confidence Interval|Number
775466|NCT00757588|Other Pre-specified|Mean Changes From Baseline in Systolic and Diastolic Blood Pressure Readings||Baseline to Weeks 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, 44, and 52|All participants who received at least 1 dose of double-blind study medication.||mm Hg||95% Confidence Interval|Number
775467|NCT00757588|Other Pre-specified|Number of Participants With at Least 1 Adverse Event (AE), at Least 1 Treatment-related AE, Death as Outcome, at Least 1 Serious Adverse Event (SAE), at Least 1 Treatment-related SAE, Discontinuations Due to SAEs, and Discontinuations Due to AEs|An AE is any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; requires inpatient hospitalization; or prolongs existing hospitalization. Treatment-related=possibly, probably, or certainly related to and of unknown relationship to study treatment.|Baseline to Week 52, continuously|All participants who received at least 1 dose of double-blind study medication.||Participants|||Number
775468|NCT00757588|Other Pre-specified|Shift in Absolute Lymphocyte Counts From Baseline to Selected Visits (LOCF)|Absolute lymphocyte count=value*10^3 c/uL|Baseline and Weeks 24 and 52|All participants who received at least 1 dose of double-blind study medication.||Participants|||Number
775469|NCT00757588|Other Pre-specified|Number of Participants With Abnormal Changes From Baseline in Electrocardiogram (ECG) Results|"ECG abnormalities included those in nonspecific other categories (Other nonspecific ST/T, Other intraventricular conduction defect, Other, and Other rhythm abnormalities)and nonspecific findings, such as sinus bradycardia, sinus arrythmia, sinus tachycardia, poor R-wave progression, and ventricular premature contractions."|Baseline to Week 52|Participants who had normal ECG findings at baseline and who received at least 1 dose of study medication.||Participants|||Number
775470|NCT00757588|Secondary|Change From Baseline in Mean Total Daily Dose of Insulin (MTDDI) (LOCF)|Based on information recorded in the participant's daily diary. The MTDDI was calculated at every visit using the values patients recorded since the last regularly scheduled visit (minimum of 80% of days with a value). At every visit, the MTDDI was compared with the participant's baseline MTDDI (measured during a 4-week lead-in period) to identify any changes in insulin use at that visit compared with insulin use at baseline.|Baseline to Week 24|Randomized participants who received at least 1 dose of double-blind study medication. Participants must also have had both a baseline and at least 1 postrandomization measurement in the 24-week period.||Units||Standard Error|Mean
775471|NCT00757588|Secondary|Percentage of Participants Achieving a Therapeutic Glycemic Response|Therapeutic glycemic response is defined as an A1C<7%. Significance was not interpreted with a p value.|Baseline to Week 24|Randomized participants who received at least 1 dose of double-blind study medication. Participants must also have had both a baseline and at least 1 postrandomization measurement in the 24-week period.||Percentage of participants|||Number
775472|NCT00757588|Secondary|Change From Baseline in Fasting Plasma Glucose Values||Baseline to Week 24|||mg/dL||Standard Error|Mean
775473|NCT00757588|Secondary|Change From Baseline in 120-minute PPG Values During an MTT|An MTT is a 2-part test that measures glucose and insulin levels after an overnight fast and before ingesting a meal consisting of a nutritional drink and power bar and again at prespecified times (30, 60, 120, and 180 minutes) after the start of ingestion of the meal.|Baseline to Week 24|||mg/dL||Standard Error|Mean
775474|NCT00757588|Secondary|Change From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Meal Tolerance Test (MTT)|An MTT is a 2-part test that measures glucose and insulin levels after an overnight fast and before ingesting a meal consisting of a nutritional drink and power bar and again at prespecified times (30, 60, 120, and 180 minutes) after the start of ingestion of the meal|Baseline to Week 24|||mg*min/dL||Standard Error|Mean
775475|NCT00757588|Primary|Adjusted Mean Change From Baseline in A1C Levels (Last Observation Carried Forward [LOCF])|Change from baseline: post-pre. Adjusted for baseline (value and metformin use). ANCOVA model: difference between week t and baseline values=baseline values + treatment + metformin use|Baseline to Week 24|Randomized participants who received at least 1 dose of double-blind study medication. Participants must also have had both a baseline and at least 1 postrandomization measurement in the 24- and 52-week periods.||Percentage of change||Standard Error|Mean
775476|NCT00757601|Secondary|Mean Area Under The Plasma Concentration Curve From Time Zero to 24 Hours (AUC[0-24]) After Single Dose MK1006|The AUC(0-24) was estimated by determining the total area under the curve of the concentration versus time curve to 24 hours post dose.|From pre-dose to 168 hours post-dose|Per-Protocol (PP) Population; The subset of participants who complied with the protocol sufficiently to ensure that data was likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance included exposure to treatment, availability of measurements and absence of major protocol violations.||nM.hr||Standard Deviation|Mean
775512|NCT00757783|Secondary|Antiviral Activity, Human Immunodeficiency Virus Type 1 (HIV-1) RNA.|Number of Participants with antiviral activity, human immunodeficiency virus Type 1 (HIV-1) RNA less than (<) 50 copies per milliliters (copies/mL) or < 400 copies/mL.|Week 12 and 48|The ITT population included participants who remained on study through Week 48 and had an assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit.||number of participants|||Number
791680|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Blood Urea Nitrogen [BUN]).||Baseline up to Month 7|||percentage of participants|||Number
775477|NCT00757601|Primary|Number of Participants Who Discontinued Treatment Due to an AE|An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the treatment, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the treatment, was also considered an adverse experience.|From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)|All Participants as Treated (APaT) Population; All participants who received at least one dose of the investigational drug.||participants|||Number
775478|NCT00757601|Secondary|Apparent Terminal Half-Life (T 1/2) of MK1006 After Single Dose|The apparent terminal half-life was defined as the time required for the plasma concentration of MK1006 to decrease 50% in the final stage of its elimination|From pre-dose to 168 hours post-dose|Per-Protocol (PP) Population; The subset of participants who complied with the protocol sufficiently to ensure that data was likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance included exposure to treatment, availability of measurements and absence of major protocol violations.||hr||Standard Deviation|Mean
775479|NCT00757601|Secondary|Median Time of Maximum Plasma Concentration (Tmax) of MK1006 After Single Dose||From pre-dose to 168 hours post-dose|Per-Protocol (PP) Population; The subset of participants who complied with the protocol sufficiently to ensure that data was likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance included exposure to treatment, availability of measurements and absence of major protocol violations.||hr||Full Range|Median
775480|NCT00757601|Secondary|Mean Maximum Plasma Concentration (Cmax) of MK1006 After Single Dose||From pre-dose to 168 hours post-dose|Per-Protocol (PP) Population; The subset of participants who complied with the protocol sufficiently to ensure that data was likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance included exposure to treatment, availability of measurements and absence of major protocol violations.||nM||Standard Deviation|Mean
775481|NCT00757601|Secondary|Mean Area Under the Plasma Concentration Curve From Time Zero to Infinity (AUC[0-∞]) After Single Dose MK1006|The AUC(0-∞) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity.|From pre-dose to 168 hours post-dose|Per-Protocol (PP) Population; The subset of participants who complied with the protocol sufficiently to ensure that data was likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance included exposure to treatment, availability of measurements and absence of major protocol violations.||nM.hr||Standard Deviation|Mean
775482|NCT00757601|Primary|Number of Participants Experiencing Adverse Events (AEs) On Study|An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the treatment, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the treatment, was also considered an adverse experience.|From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)|All Participants as Treated (APaT) Population; All participants who received at least one dose of the investigational drug.||participants|||Number
775483|NCT00757627|Secondary|Change From Baseline in Patient-SF36 (Short Form 36) Domain Scores at Week 4|Weighted scores of the 8 domains of SF36 (i.e., physical functioning; role limiting due to physical problem; bodily pain; general health; vitality; social functioning; role limiting due to emotional problem; mental health) were scored on a scale from 0 ~100, with 100 representing the best possible functioning)|Baseline and Week 4|Intention to treat (ITT)||Units on a Scale||Standard Deviation|Mean
775484|NCT00757627|Secondary|Change From Baseline in Number of Days Patient Miss From Work or House Keeping Work at Week 4||Baseline and Week 4|Only patients with both baseline and week 4 data were included in this analysis.||Days||Standard Deviation|Mean
775485|NCT00757627|Secondary|Changes From Baseline in Patient TSQM (Treatment Satisfaction Questionnaire for Medication) Domain Scores at Week 4|TSQM consists of four domains (effectiveness; side effect; convenience and overall satisfaction), domain scores ranged from 0 (0=worst) to 100 (100=best) were derived from converting the original Likert's scales to VAS scale.|Baseline and Week 4|"22 patients who reported side effects at baseline and week 4 were included in side effect evaluation."||Units on a Scale||Standard Deviation|Mean
775486|NCT00757627|Secondary|Change From Baseline of Patient BPI (Brief Pain Inventory) Scores at Week 4|BPI consists of pain and pain interference domains. For pain (0=no pain to 10=extreme pain); for pain interference ( 0=no interference to 10= greatest interference).|Baseline and Week 4|Only patients with both baseline and week 4 follow up data were included in this analysis.||Units on a Scale||Standard Deviation|Mean
775487|NCT00757627|Secondary|Patient Assessment of General Health Outcome by EuroQoL-5 Dimensions (EQ-5D) at Week 4|The percentage of participants who met the criteria of any of the 3 categories of EQ-5D at baseline and at week 4 were collected.The EQ-5D comprises of 5 dimensions (mobility, self-care, usual activities, pain / discomfort, and anxiety / depression) to be answered using a 3-categorical Likert's scales of: [No problem, Some problem, and Not able to carry out] for mobility, self-care and usual activities and [ Not present, moderate and extreme]for discomfort and anxiety/depression|Week 4|per protocol||Percentage of participants|||Number
775488|NCT00757627|Secondary|Patient Assessment of General Health Outcome by EuroQoL-5 Dimensions (EQ-5D) at Baseline|The percentage of participants who met the criteria of any of the 3 categories of EQ-5D at baseline and at week 4 were collected.The EQ-5D comprises of 5 dimensions (mobility, self-care, usual activities, pain / discomfort, and anxiety / depression) to be answered using a 3-categorical Likert's scales of: [No problem, Some problem, and Not able to carry out] for mobility, self-care and usual activities and [Not present, moderate and extreme] for discomfort and anxiety/depression.|Baseline|"Only patients with baseline and week 4 data were included in the analysis.
Week 4 N Values; Motility 423 , Self care 422 , Daily Activity 421 , Pain/Discomfort 421 , Anxiety/Depressed 422"||Percentage of Participants|||Number
775527|NCT00757822|Secondary|Post-Operative Care Unit Length of Stay (Min)|Length of time in PACU (minutes) measured from end of surgery to time of transfer to ambulatory care prior to home discharge or time to hospital admission if applicable.|Day of surgery (time from end of surgery to transfer to ambulatory pre-discharge unit or other unit)|||minutes||Inter-Quartile Range|Median
775489|NCT00757627|Primary|"The Percentage of Participants Achieving ≥30% Decrease From Baseline in Pain Intensity as Measured by WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) Question 1 Pain Walking on a Flat Surface at Week 4"|"WOMAC for pain assessment by patient (0-100 mm Visual Analog Scale (VAS) with 0 represent no pain and 100 represent extreme pain)"|Baseline and end of week 4|"Per protocol (all patients who completed the WOMACpain walking on a flat surface  question at baseline and follow up visit at week 4 will be included for analysis of this endpoint.
Among the 419 patients with follow up visit data, 27 patients rated 0 in their VAS pain score at baseline and were excluded from this analysis."||Percentage of Participants|||Number
775490|NCT00757627|Secondary|Physicians' Global Assessment of Patients' Response to Therapy at Week 4 Using IGART|The IGART comprised of five categories: No response, poor response, fair response, good response, and excellent response. The percentage of participants met the criteria of any of the 5 categories at week 4 were collected.|Week 4|Per Protocol||Percentage of Participants|||Number
775491|NCT00757627|Secondary|Physicians' Global Assessment of Patients' Response to Therapy at Baseline Using IGART (Investigator Global Assessment of Response to Therapy)|The IGART comprised of five categories: No response, poor response, fair response, good response, and excellent response. The percentage of participants who met the criteria of any of the 5 categories at baseline were collected.|Baseline|Only patients with baseline and week 4 data were included.||Percentage of Participants|||Number
775492|NCT00757627|Secondary|Mean Change From Baseline in Patient WOMAC Domain Scores at Week 4|The change from baseline in 3 domain scores (pain, stiffness, and difficult in doing daily activity) of WOMAC at week 4 were measured. Each domain comprises of questions and VAS scales for scoring. For pain domain, 0 represents no pain and 100 represents extreme pain; for stiffness domain, 0 represents no stiffness and 100 represents extreme stiffness; for difficult in doing daily activity domain, 0 represents no difficulty and 100 represents most difficulty.|Baseline and Week 4|Only patients with baseline and week 4 data were included in this analysis of change||Units on a Scale||Standard Deviation|Mean
775493|NCT00757666|Secondary|VO2 at Ventilatory Threshold||1 month and 2 months post-implant|Data was not analyzed since patient enrollment was ceased and study was prematurely terminated.|||||
775494|NCT00757666|Secondary|Exercise Time||1 month and 2 months post-implant|Data was not analyzed since patient enrollment was ceased and study was prematurely terminated.|||||
775495|NCT00757666|Secondary|Metabolic Chronotropic Relationship (MCR) Slope||1 month and 2 months post-implant|Data was not analyzed since patient enrollment was ceased and study was prematurely terminated.|||||
775496|NCT00757666|Secondary|Changes in Heart Rate During Activities of Daily Living (ADL) Using a Lift and Carry Test|This outcome measure will be compared against baseline.|2 months post-implant|Data was not analyzed since patient enrollment was ceased and study was prematurely terminated.|||||
775497|NCT00757666|Primary|Mean Change in Functional Capacity (Peak VO2).|"The APPROPRIATE Study compared differences in functional capacity (peak VO2) between CI patients randomized to receive rate responsive pacing driven by either the minute ventilation (respiration-based) sensor or by an accelerometer (motion-based) sensor.
The mean change in functional capactity will be compared against baseline; changes from baseline will be measured."|1 month and 2 months post-implant|Data was not analyzed since patient enrollment was ceased and study was prematurely terminated.|||||
775498|NCT00757705|Secondary|Change From Baseline in Sleep Quality and Daytime Drowsiness Score at Week 24|The Sleep Quality and Daytime Drowsiness evaluation scale is a self-administered scale that rates quality of sleep and daytime drowsiness. Participants indicated on a 5 point scale how well they have slept in the previous 7 days, score ranging from 1 (very badly) to 5 (very well) and how often they have felt drowsy within the previous 7 days, score ranging from 1 (not at all) to 5 (all the time).|Baseline, Week 24|ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here, 'n' signifies those participants who were evaluable for this outcome measure at specified time point.||Units on a scale||Standard Deviation|Mean
775499|NCT00757705|Secondary|Number of Participants With Satisfaction With the Study Treatment|Participants assessed their satisfaction with paliperidone ER on a 5-point scale (very good, good, moderate, poor or very poor).|Week 24|ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here 'N' (Number of Participants Analyzed) signifies participants evaluable for this measure.||Participants|||Number
775500|NCT00757705|Secondary|Change From Baseline in Short-Form 36 Health Survey (SF-36) Score at Week 24|The SF-36 is a health status survey with 36 questions measuring 8 dimensions (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health) that are subsequently aggregated into 2 summary scales, Physical Component Summary (PCS) and Mental Component Summary (MCS). Each item is scored into on a 0-100 range so that the lowest and highest possible scores are set at 0 and 100, respectively. All items are scored so that a high score defines a more favorable health state.|Baseline, Week 24|ITT population: all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Missing data was imputed using LOCF. Here 'N' (Number of Participants Analyzed) signifies number of participants who were evaluable for this measure. 'n' signifies those participants who were evaluable at specified time point.||Units on a scale||Standard Deviation|Mean
775501|NCT00757705|Secondary|Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 24|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants."|Baseline, Week 24|ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Missing data was imputed using LOCF. Here, 'n' signifies those participants who were evaluable for this outcome measure at specified time point.||Units on a scale||Standard Deviation|Mean
775528|NCT00757822|Primary|Post-operative Nausea and Vomiting (PONV) Incidence 24-48 Hours Post Surgery|Participants were queried for presence of postoperative nausea (PON) or postoperative vomiting (POV) during the 24-48 hr window post surgery.|24-48 hrs post surgery|||percentage of participants|||Number
775827|NCT00754065|Secondary|Onset of Withdrawal Bleeding Episodes at Cycle 6|Onset was defined as the number of days between progestogen withdrawal and the first day of the withdrawal bleeding episode (ie, starting on or after Day 25 for EV/DNG and on or after Day 22 for EE/NGM).|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
775502|NCT00757705|Secondary|Change From Baseline in Global Assessment of Functioning (GAF) Score at Week 24|The GAF is a 100-point tool rating overall psychological, social and occupational functioning of adults. The higher score range (91-100) refers to a superior functioning in a wide range of activities, and absence of symptoms. The lower score range (1-10) refers to persistent danger of severely hurting self or others; or persistent inability to maintain minimum personal hygiene; or serious suicidal act with clear expectation of death.|Baseline, Week 24|ITT population: all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Missing data was imputed using LOCF. Here 'N' (Number of Participants Analyzed) signifies number of participants who were evaluable for this measure. 'n' signifies those participants who were evaluable at specified time point.||Units on a scale||Standard Deviation|Mean
775503|NCT00757705|Secondary|Change From Baseline in Total Personal and Social Performance (PSP) Score at Week 24|The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty).|Baseline, Week 24|ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Missing data was imputed using LOCF. Here, 'n' signifies those participants who were evaluable for this outcome measure at specified time point.||Units on a scale||Standard Deviation|Mean
775504|NCT00757705|Secondary|Percentage of Participants With at Least 20 Percent Improvement in Positive and Negative Syndrome Scale (PANSS) Total Score|The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self). The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent) to 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity.|Up to Week 24|ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here 'N' (Number of Participants Analyzed) signifies participants evaluable for this measure.||Percentage of participants|||Number
775505|NCT00757705|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Week 24|The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). Marder PANSS subscales include positive symptoms subscale consisting of 8 items with total score range of 8-56; negative symptoms subscale and disorganized thoughts subscale, each consisting of 7 items with total score range of 7-49; and uncontrolled hostility/excitement (UH/E) subscale and anxiety/depression subscale, each consisting of 4 items with total score range of 4-28. Higher score indicates greater severity.|Baseline, Week 24|ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Missing data was imputed using LOCF. Here, 'n' signifies those participants who were evaluable for this outcome measure at specified time point.||Units on a scale||Standard Deviation|Mean
775506|NCT00757705|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 24|The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self). The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent) to 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity.|Baseline, Week 24|Intent-to-treat (ITT) population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Missing data was imputed using last observation carried forward (LOCF). Here, 'n' signifies those participants who were evaluable for this outcome measure at specified time point.||Units on a scale||Standard Deviation|Mean
775507|NCT00757783|Secondary|Change From Baseline in Cluster of Differentiation (CD) 4 Percent at Week 12 and 48, Last Observation Carried Forward (LOCF).|Participants' Cluster of Differentiation (CD) 4 percent were observed at baseline and the change values at Week 12 and 48 was calculated using LOCF.|Baseline, Week 12 and 48|The ITT population included participants who remained on study through Week 48 and had an assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. LOCF was applied. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||percentage of CD4 cells||Standard Deviation|Mean
775508|NCT00757783|Secondary|Change From Baseline in Cluster of Differentiation (CD) 4 Cell Count at Week 12 and 48, Last Observation Carried Forward (LOCF).|Participants' Cluster of Differentiation (CD) 4 Cell Count were observed at baseline and the change values at Week 12 and 48 was calculated using LOCF.|Baseline, Week 12 and 48|The ITT population included participants who remained on study through Week 48 and had an assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. LOCF was applied. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||cells/uL||Standard Deviation|Mean
775509|NCT00757783|Secondary|Change From Baseline in CD4 Cell Count at Week 12 and 48, Observed Values.|Participants' Cluster of Differentiation (CD) 4 Cell Count were at baseline and the change values at Week 12 and 48 were observed.|Baseline, Week 12 and 48|The ITT population included participants who remained on study through Week 48 and had an assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||cells/micro L||Standard Deviation|Mean
775510|NCT00757783|Secondary|Change From Baseline in HIV-1 RNA Viral Load at Week 12 and 48.|the HIV-1 RNA viral load was calculated using Log Base 10 transformed HIV-1 RNA observed values.|Baseline, Week 12 and 48|The ITT population included participants who remained on study through Week 48 and had an assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||Log10 HIV RNA||Standard Deviation|Mean
775513|NCT00757783|Secondary|Change From Baseline in Homeostasis Model Assessment–Insulin Resistance (HOMA-IR) at Week 12 and 48.|Participants homeostasis model assessment-insulin resistance (HOMA-IR) were observed and change from Baseline were reported. HOMA-IR score was calculated as: (fasting plasma glucose*fasting serum insulin)/22.5. Low HOMA IR values indicate high insulin sensitivity and high HOMA IR values indicate low insulin sensitivity (insulin resistance).|Baseline, Week 12 and 48|The ITT population included participants who remained on study through Week 48 and had an assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. ‘N’=participants evaluable for this measure and 'n'=participants evaluable for this outcome measure at specified time points for each group, respectively.||HOMA-IR score||Standard Deviation|Mean
775514|NCT00757783|Secondary|Change From Baseline in Insulin at Week 12 and 48.|Participants insulin was analyzed at Baseline and Week 12 and 48 and change from Baseline at Week 12 and 48 were reported.|Baseline, Week 12 and 48|The ITT population included participants who remained on study through Week 48 and had an assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. ‘N’=participants evaluable for this measure and 'n'=participants evaluable for this outcome measure at specified time points for each group, respectively.||IU/mL||Standard Deviation|Mean
775515|NCT00757783|Secondary|Change From Baseline in Glucose at Week 12 and 48.|Participants glucose level was analyzed at Baseline and Week 12 and 48. Change from Baseline at Week 12 and 48 was reported.|Baseline, Week 12 and 48|Intent-to-treat (ITT) population included participants who remained on study through Week 48 and had an assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. ‘N’=participants evaluable for this measure and 'n'=participants evaluable for this outcome measure at specified time points for each group.||mg/dL||Standard Deviation|Mean
775516|NCT00757783|Secondary|Change From Baseline in TC/HDL Ratio in the LE Set at Week 12 and 48.|Participants TC and HDL was analyzed at Baseline and Week 12 and 48. Change from Baseline at Week 12 and 48 was calculated as ratio using observed values.|Baseline, Week 12 and 48|The LE set consisted of all subjects in the PP analysis set who remained on study through Week 48 and had a fasting lipid assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||ratio||Standard Deviation|Mean
775517|NCT00757783|Secondary|Change From Baseline in Apolipoprotein B in the LE Set at Week 12 and 48.|Observed Values|Baseline, Week 12 and 48|The LE set consisted of all subjects in the PP analysis set who remained on study through Week 48 and had a fasting lipid assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||g/L||Standard Deviation|Mean
775518|NCT00757783|Secondary|Change From Baseline in Apolipoprotein A1 in the LE Set at Week 12 and 48.|Observed Values|Baseline, Week 12 and 48|The LE set consisted of all subjects in the PP analysis set who remained on study through Week 48 and had a fasting lipid assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||grams per liters (g/L)||Standard Deviation|Mean
775519|NCT00757783|Secondary|Change From Baseline in High Density Lipoprotein (HDL) in the LE Set at Week 12 and 48.|Observed Values|Baseline, Week 12 and 48|The LE set consisted of all subjects in the PP analysis set who remained on study through Week 48 and had a fasting lipid assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||mg/dL||Standard Deviation|Mean
775520|NCT00757783|Secondary|Change From Baseline in Low Density Lipoprotein (LDL) Direct in the LE Set at Week 12 and 48.|Observed Values|Baseline, Week 12 and 48|The LE set consisted of all subjects in the PP analysis set who remained on study through Week 48 and had a fasting lipid assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||mg/dL||Standard Deviation|Mean
775521|NCT00757783|Secondary|Change From Baseline in Total Cholesterol (TC) Levels in the LE Set at Week 12 and 48|Observed Values|Baseline, Week 12 and 48|The LE set consisted of all subjects in the PP analysis set who remained on study through Week 48 and had a fasting lipid assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||mg/dL||Standard Deviation|Mean
775522|NCT00757783|Primary|Change From Baseline in Fasting Triglyceride (TG) Levels in the Lipid Evaluable (LE) Set at Week12|Observed values.|Baseline, Week 12|The LE set consisted of all subjects in the PP analysis set who remained on study through Week 48 and had a fasting lipid assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||milligram per deciliters (mg/dL)||Standard Deviation|Mean
775523|NCT00757822|Secondary|Patient Satisfaction 2: Willingness to Pay Extra Money for Post-Operative Nausea and Vomiting (PONV) Preventive Medication|Percent of participants willing to pay extra money for preemptive medication for PONV for subsequent surgical procedures when queried at post-operative 24-48 hr. and at 2-6 wk. follow-up interviews.|Post-operative follow-up interviews 24 hr to 6 weeks post surgery|||percent of participants|||Number
775524|NCT00757822|Secondary|Patient Satisfaction: Willingness to Take Pre-operative Medication for Post-operative Nausea and/or Vomiting|Percent of participants who responded that they would be willing to take preemptive medication for nausea and vomiting for subsequent surgeries when queried during post-operative follow-up interviews at 24-48 hrs or 2-6 weeks.|Post operative follow up interviews 24 hrs to 6 wks|||percent of participants|||Number
775525|NCT00757822|Secondary|Post-operative Antiemetic Use|Percentage of participants requiring post-operative anti-emetic medications.. Anti-emetic medication need was assessed during a) post-operative care unit (PACU) stay and b)during the first 48 hrs. following discharge from PACU to home or if applicable to in-patient unit.|End of surgery to 48 hr post surgery|||percentage of participants|||Number
775526|NCT00757822|Secondary|Post-Surgery Hospital Admissions (All Cause) After Out-patient Abdominal Procedure|Number of all-cause hospital admissions on day of elective out-patient surgery .|Post-operative Day of Surgery (DOS)|||participants|||Number
775529|NCT00757822|Primary|Maximum Reported Post-Operative Nausea Scores on Visual Analog Scale (VAS) Scale|"VAS Scale: 0=no nausea, 1-3=mild nausea, 4-6= moderate nausea, 7-9= severe nausea, 10=extreme nausea usually accompanied with vomiting.
VAS nausea score were obtained every 30 min from entry into post-operative care unit (PACU) for first 2 hrs. and then hourly until time of transfer out of PACU."|Post-operative Care Unit (PACU) stay from end of surgery to transfer to ambulatory unit|||percentage of participants|||Number
775530|NCT00757822|Primary|Incidence of Postoperative Nausea and Vomiting|The incidence of postoperative nausea (PON) and postoperative vomiting (POV) was assessed during Post-operative Care Unit (PACU) stay.|Post-operative Care Unit (PACU) length of stay on day of surgery (time from end of surgery to transfer to discharge unit or other hospital unit)|Per protocol||percentage of participants|||Number
775531|NCT00757848|Secondary|Ratio of Urine Desmosine (Total) (Normalised for Creatinine) at End of Treatment Compared to Baseline|Ratio of day 28 to baseline|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||ratio||95% Confidence Interval|Least Squares Mean
775532|NCT00757848|Secondary|Ratio of Urine Desmosine (Free) (Normalised for Creatinine) at End of Treatment Compared to Baseline|Ratio of day 28 to baseline|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||ratio||95% Confidence Interval|Least Squares Mean
775533|NCT00757848|Secondary|Ratio of Sputum Leukotriene B4 (LTB4) at End of Treatment Compared to Baseline|Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits|End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||ratio||95% Confidence Interval|Least Squares Mean
775534|NCT00757848|Secondary|Ratio of Sputum Interleukin 8 (IL-8) at End of Treatment Compared to Baseline|Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits|End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||ratio||95% Confidence Interval|Least Squares Mean
775535|NCT00757848|Secondary|Ratio of Sputum Monocyte Chemoattractant Protein-1 (MCP-1) at End of Treatment Compared to Baseline|Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits|End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||ratio||95% Confidence Interval|Least Squares Mean
775536|NCT00757848|Secondary|Ratio of Sputum Regulated on Activation, Normal T Cell Expressed and Secreted (RANTES) at End of Treatment Compared to Baseline|Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits|End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||ratio||95% Confidence Interval|Least Squares Mean
775537|NCT00757848|Secondary|Ratio of Sputum Interleukin 1 Beta (IL-1β) at End of Treatment Compared to Baseline|Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits|End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||ratio||95% Confidence Interval|Least Squares Mean
775538|NCT00757848|Secondary|Ratio of Sputum Interleukin 6 (IL-6) at End of Treatment Compared to Baseline|Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits|End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||ratio||95% Confidence Interval|Least Squares Mean
775539|NCT00757848|Secondary|Ratio of Sputum Tumour Necrosis Factor Alpha (TNF α) at End of Treatment Compared to Baseline|Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits|End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits.Values from day 21 to 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||ratio||95% Confidence Interval|Least Squares Mean
775554|NCT00758043|Secondary|Proportion of Randomized Subjects Who Relapse, Defined as Those Who Complete Treatment, Have Undetectable HCV RNA at End of Treatment (EOT; Week 24 or Week 48 Respectively), and Become HCV RNA Detectable During Antiviral Follow-up||Week 24 or Week 28||||||
775860|NCT00754065|Secondary|Number of Days With Spotting-only in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
775540|NCT00757848|Primary|Cystic Fibrosis Questionnaire (CFQ-R) - Quittner|Cystic Fibrosis Questionnaire Overall Score as a measure of quality of life and disease symptoms. Scores range from 0 to 100, with higher scores indicating better health. The overall score is the sum of 12 subscores. Change from baseline to day 28.|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||units on a scale||Standard Error|Least Squares Mean
775541|NCT00757848|Primary|Bronkotest Diary Card Signs and Symptoms|The Bronkotest diary card includes 8 questions on signs and symptoms. Symptom scores were recorded for night-time symptoms, breathing, sputum colour, sputum amount, sputum type, wellbeing, and cough, generally scored on a scale from 0 (no symptoms) to 4 (worst symptoms). ANOVA models were fitted to compare the change from baseline between AZD9668 and placebo for each question separately, with a p-value of 0.1 considered statistically significant. The number of number of these 8 measures with significant differences is reported.|The last 7 days on treatment|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||Signs and Symptoms|||Number
775542|NCT00757848|Primary|Evening Peak Expiratory Flow (PEF)|Evening Peak Expiratory Flow (L/min) as a measure of lung function.Change from baseline value to mean of the last 7 days on treatment|The last 7 days on treatment|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L/min||Standard Error|Least Squares Mean
775543|NCT00757848|Primary|Morning Peak Expiratory Flow (PEF)|Morning Peak Expiratory Flow (L/min) as a measure of lung function.Change from baseline value to mean of the last 7 days on treatment|Last 7 days on treatment|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L/min||Standard Error|Least Squares Mean
775544|NCT00757848|Primary|Forced Vital Capacity (FVC)|Forced Vital Capacity (L) as a measure of lung function. Change from Baseline to day 28.|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Error|Least Squares Mean
775545|NCT00757848|Primary|Forced Expiratory Flow Between 25 and 75% of Forced Vital Capacity (FEF25-75%)|FEF25-75% (L) as a measure of lung function. Change from Baseline to day 28.|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Error|Least Squares Mean
775546|NCT00757848|Primary|Slow Vital Capacity (SVC)|Slow Vital capacity (L) as a measure of lung function. Change from Baseline to day 28.|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Error|Least Squares Mean
775547|NCT00757848|Primary|Forced Expiratory Volume in 1 Second (FEV1)|Forced Expiratory Volume in 1 second (L) as a measure of lung function.Change from Baseline to day 28.|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Error|Least Squares Mean
775548|NCT00757848|Primary|24-hour Sputum Weight|Sputum weight (g) collected during 24 hour periods. Change from Baseline to day 28.|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||grams||Standard Error|Least Squares Mean
775549|NCT00757848|Primary|Sputum Percentage Neutrophil Count|Percentage of neutrophils in white blood cell count.Change from Baseline (mean of 2 baseline visits) to the end of the treatment period (mean of 2 visits at the end of the treatment)|Baseline and Values from day 21 to 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||percentage of neutrophils in WBCs||Standard Error|Least Squares Mean
775550|NCT00757848|Primary|Ratio of Sputum Absolute Neutrophil Count at End of Treatment Compared to Baseline|Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits|Baseline and Values from day 21 to 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||ratio||95% Confidence Interval|Least Squares Mean
775551|NCT00758043|Secondary|Adverse Events, Physical Examination Findings, and Clinical Laboratory, Vital Sign, and Electrocardiogram (ECG) Assessments||Week 72||||||
775552|NCT00758043|Secondary|Proportion of Subjects Who Have Undetectable HCV RNA at the EOT (Week 24 or Week 48 Respectively).||Week 24 or Week 48|||participants|||Number
775553|NCT00758043|Secondary|Proportion of Enrolled Subjects Who Relapse, Defined as Those Who Have Undetectable HCV RNA at the EOT, and Become HCV RNA Detectable During Antiviral Follow-up||Week 72||||||
775555|NCT00758043|Secondary|Proportion of Randomized Subjects Who Have Undetectable HCV RNA 12 Weeks After Last Dose of Study Treatment|SVR12 is defined as undetectable HCV RNA levels 12 weeks after the last planned dose of study treatment.|12 weeks after last dose of study treatment|The population analyzed included all subjects in the Full Analysis (FA) Set. All subjects in the FA Set received at least 1 dose of study drug.||participants|||Number
775556|NCT00758043|Secondary|Proportion of Subjects Achieving eRVR (Extended RVR), Demonstrated by Achieving Undetectable HCV RNA at Week 4 and at Week 12|Extended rapid viral response is defined undetectable HCV RNA levels at Week 4 and Week 12 (on treatment).|Week 4 and Week 12|The population analyzed included all subjects in the Full Analysis (FA) Set. All subjects in the FA Set received at least 1 dose of study drug.||participants|||Number
775557|NCT00758043|Secondary|Proportion of Subjects Who Have Undetectable HCV RNA at Week 72|SVR at Week 72 is defined as achieved SVR24planned and undetectable HCV RNA at Week 72 without any confirmed detectable HCV RNA levels in between those visits.|72 weeks after the last planned dose of study treatment|The population analyzed included all subjects in the Full Analysis (FA) Set. All subjects in the FA Set received at least 1 dose of study drug.||participants|||Number
775558|NCT00758043|Primary|Proportion of Randomized Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable HCV RNA 24 Weeks After Last Dose of Study Treatment (SVR24)|SVR24planned was used to measure the primary outcome. SVR24 planned is defined as undetectable HCV RNA levels at the end of treatment (EOT) visit and at 24 weeks after the last planned dose of study treatment without any confirmed detectable HCV RNA levels in between those visits. All plasma HCV RNA levels were assessed using the Roche TaqMan HCV RNA assay (Version 2.0, lower limit of quantification [LLOQ] of 25 IU/mL).|24 weeks after the last planned dose of study treatment|The population analyzed included all subjects in the Full Analysis (FA) Set. All subjects in the FA Set received at least 1 dose of study drug.||participants|||Number
775559|NCT00758069|Secondary|Change From Baseline in Plasma Glucose|Change from baseline at Week 4 is defined as fasting plasma glucose at Week 4 minus fasting plasma glucose at Week 0.|Baseline and Week 4|The Per Protocol population included patients with baseline and Week 4 (i.e., final primary timepoint) values for this outcome and excluded patients who met predefined criteria for protocol violations.||mg/dL||95% Confidence Interval|Least Squares Mean
775560|NCT00758069|Primary|Change From Baseline in 24-hour Weighted Mean Plasma Glucose|Change from baseline at Week 4 is defined as 24-hour weighted mean glucose (24hr-WMG) at Week 4 minus 24hr-WMG at Week 0.|Baseline and Week 4|The Per Protocol population included patients with baseline and Week 4 (i.e., final primary timepoint) values for this outcome and excluded patients who met predefined criteria for protocol violations.||mg/dL||95% Confidence Interval|Least Squares Mean
775561|NCT00758160|Other Pre-specified|Global Assessment of Satisfaction by Participant|Participants were asked to assess their satisfaction with respect to ADHD treatment on a 5-point scale ranging from 1 to 5 where 1=completely dissatisfied, 2=somewhat dissatisfied, 3=neutral, 4=somewhat satisfied and 5=completely satisfied.|Baseline, Week 2, 4 and 8|ITT analysis set included of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.||Units on a scale||Standard Deviation|Mean
775562|NCT00758160|Secondary|Global Assessment of Satisfaction by Parents/Caregivers|Parents/caregivers were asked to assess the satisfaction with respect to ADHD treatment on a 5-point scale ranging from 1 to 5 where 1=completely dissatisfied, 2=somewhat dissatisfied, 3=neutral, 4=somewhat satisfied, and 5=completely satisfied.|Baseline, Week 2, 4 and 8|ITT analysis set included of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.||Units on a scale||Standard Deviation|Mean
775563|NCT00758160|Secondary|Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score|CGI-I is a single item assessment of the global improvement of ADHD symptoms in relation to the clinician’s total experience after reviewing all the returned questionnaires and clinical assessment of participants’ behavioral symptoms. Improvement is rated on a 7-point scale (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse).|Baseline, Week 2, 4 and 8|ITT analysis set included of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.||Participants|||Number
775564|NCT00758160|Secondary|Clinical Global Impression-Severity (CGI-S) Score|CGI-ADHD-S is a single item assessment of the global severity of ADHD symptoms in relation to the clinician’s total experience after reviewing all the returned questionnaires and clinical assessment of participants’ behavioral symptoms. Severity is rated on a 7-point scale ranging from 1 to 7 with 1=normal (not at all ill) and 7=most extremely ill.|Baseline, Week 2, 4 and 8|ITT analysis set included of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.||Units on a scale||Standard Deviation|Mean
775565|NCT00758160|Secondary|Social Adjustment Scale Score for Children and Adolescents (SAICA)|SAICA is a 77-item semi-structured interview scale designed for administration to school-aged children with age 6-18 years, or to their parents about their children. SAICA provides an evaluation of children’s current functioning in the domains of school, spare time, peer relations, and home behaviors. Each item ranged on a 4-point likert scale ranging from 1 to 4 with a higher mean score indicating either poorer social function or a more severe social problem.|Baseline, Week 4 and Week 8|ITT analysis set included of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.||Units on a scale||Standard Deviation|Mean
775861|NCT00754065|Secondary|Number of Days With Spotting-only in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
775566|NCT00758160|Secondary|Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Teachers) Score|Teachers were asked to assess the children on a 26-item Chinese SNAP-IV questionnaire consisting of inattention (items 1-9; subscore range 0-27), hyperactivity (items 10-18; subscore range 0-27) and oppositional (19-26, subscore range 0-24) subscales used to assess the qualitative judgments in Attention Deficit Hyperactivity Disorder (ADHD). Each item was based on a 4-point likert scale ranging from 0 (not at all) to 3 (very much). The overall score ranged from 0 to 78. The total score for Inattention and hyperactivity ranged from 0 to 27 and for oppositional ranged from 0 to 21.|Baseline, Week 2, 4 and 8|ITT analysis set included of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.||Units on a scale||Standard Deviation|Mean
775567|NCT00758160|Secondary|Chinese Version of the Family Adaptation, Partnership, Growth, Affection, and Resolve (Family APGAR-C) Score|Parents of the participants were asked to assess the Family APGAR which is a 5-item questionnaire designed to assess the 5 dimensions of perceived family support: Adaptation, Partnership, Growth, Affection, and Resolve. Each item is rated on a 3-point scale ranging from 0 to 2 where 0=hardly ever, 1=some of the time and 2=almost always. The total score ranges from 0 to 10 with greater scores indicating greater family support.|Baseline, Week 4 and 8|ITT analysis set included parents of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.||Units on a scale||Standard Deviation|Mean
775568|NCT00758160|Primary|Mean Change From Baseline in Chinese Health Questionnaire (CHQ) at Week 8|The CHQ is a self administered screening instrument used to assess psychiatric morbidity in the Chinese community. It was derived from the General Health Questionnaire, and has been validated with satisfactory construct validity and applied in the survey of psychiatric morbidity in the community and in hospital settings. Four factors are included in the structure: somatic symptoms; anxiety and worrying; sleep problems; and depression and poor family relationships. It contains 12 items, with a maximum score of 12. CHQ scores indicated the severity of participants’ psychological problems (0–2=normal; 3–4=minor; 5–6=moderate; and 7–12=severe psychological problems). Mean Change was calculated as mean CHQ score at Week 8 minus mean CHQ score at Baseline.|Baseline and Week 8|ITT analysis set included parents of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.||Units on a scale||Standard Deviation|Mean
775569|NCT00758160|Primary|Mean Change From Baseline in Chinese Health Questionnaire (CHQ) at Week 4|The CHQ is a self administered screening instrument used to assess psychiatric morbidity in the Chinese community. It was derived from the General Health Questionnaire, and has been validated with satisfactory construct validity and applied in the survey of psychiatric morbidity in the community and in hospital settings. Four factors are included in the structure: somatic symptoms; anxiety and worrying; sleep problems; and depression and poor family relationships. It contains 12 items, with a maximum score of 12. CHQ scores indicated the severity of participants’ psychological problems (0–2=normal; 3–4=minor; 5–6=moderate; and 7–12=severe psychological problems). Mean Change was calculated as mean CHQ score at Week 4 minus mean CHQ score at Baseline.|Baseline and Week 4|ITT analysis set included parents of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.||Units on a scale||Standard Deviation|Mean
775570|NCT00758160|Primary|Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 8|Parents were asked to assess their children on a 26-item Chinese SNAP-IV questionnaire consisting of inattention (items 1-9; subscore range 0-27), hyperactivity (items 10-18; subscore range 0-27) and oppositional (19-26, subscore range 0-24) subscales used to assess the qualitative judgments in Attention Deficit Hyperactivity Disorder (ADHD). Each item was based on a 4-point likert scale ranging from 0 (not at all) to 3 (very much). The overall score ranged from 0 to 78. The total score for Inattention and hyperactivity ranged from 0 to 27 and for oppositional ranged from 0 to 21. Mean Change was calculated as mean SNAP-IV score at Week 8 minus mean SNAP-IV score at Baseline.|Baseline and Week 8|ITT analysis set included all participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. Here, 'n' included those participants who were evaluable for this measure at the specified time point.||Units on a scale||Standard Deviation|Mean
775571|NCT00758160|Primary|Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 4|Parents were asked to assess their children on a 26-item Chinese SNAP-IV questionnaire consisting of inattention (items 1-9; subscore range 0-27), hyperactivity (items 10-18; subscore range 0-27) and oppositional (19-26, subscore range 0-24) subscales used to assess the qualitative judgments in Attention Deficit Hyperactivity Disorder (ADHD). Each item was based on a 4-point likert scale ranging from 0 (not at all) to 3 (very much). The overall score ranged from 0 to 78. The total score for Inattention and hyperactivity ranged from 0 to 27 and for oppositional ranged from 0 to 21. Mean Change was calculated as mean SNAP-IV score at Week 4 minus mean SNAP-IV score at Baseline.|Baseline and Week 4|ITT analysis set included all participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. Here, 'n' included those participants who were evaluable for this measure at the specified time point.||Units on a scale||Standard Deviation|Mean
775592|NCT00758485|Secondary|Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.7|Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (height) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (a percentage that is expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB, with a higher ratio indicating a greater recovery from NMB.|From Start of IMP Administration to Recovery of the T4/T1 Ratio to 0.7 (estimated from ~1 minute up to ~70 minutes)|The ITT Population consisted of all participants who received either Sugammadex or Placebo and had at least one efficacy measurement. Imputed recovery times were used in cases of missing times.||minutes||95% Confidence Interval|Geometric Mean
775572|NCT00758160|Primary|Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 2|Parents were asked to assess their children on a 26-item Chinese SNAP-IV questionnaire consisting of inattention (items 1-9; subscore range 0-27), hyperactivity (items 10-18; subscore range 0-27) and oppositional (19-26, subscore range 0-24) subscales used to assess the qualitative judgments in Attention Deficit Hyperactivity Disorder (ADHD). Each item was based on a 4-point likert scale ranging from 0 (not at all) to 3 (very much). The overall score ranged from 0 to 78. The total score for Inattention and hyperactivity ranged from 0 to 27 and for oppositional ranged from 0 to 21. Mean Change was calculated as mean SNAP-IV score at Week 2 minus mean SNAP-IV score at Baseline.|Baseline and Week 2|Intent-to-treat (ITT) analysis set included all participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. Here, 'n' included those participants who were evaluable for this measure at the specified time point.||Units on a scale||Standard Deviation|Mean
775573|NCT00758290|Primary|Dental Plaque Index|Plaque units measured on a scale between 0 to 5. No plaque=0;5=2/3 of tooth covered in plaque|4 Day|||Units on a scale||Standard Deviation|Mean
775574|NCT00758342|Primary|Mean IOP (Intraocular Pressure)||Screening: Week 12; (At 9 am and 4 pm time points)|||mm Hg (millimeters mercury)||Standard Deviation|Mean
775575|NCT00758394|Primary|Dental Plaque Index|plaque units measured on a scale between 0 to 5. 0 = No plaque; 5 = 2/3 of Tooth covered in plaque.|4-Day|||Units on a scale||Standard Deviation|Mean
775576|NCT00758420|Primary|The Absolute Change From Baseline Score for the VVSymQ (Total Score) at 8 Weeks|The VVSymQ is a subset of the VEINES-Sym and consists of the 5 symptoms most relevant to patients. The raw score, which can range from 5 to 30, was transformed to a summary VVSymQ score that ranges from 0 (worst possible symptom health) to 100 (best symptom health) using the following formula: VVSymQ: (Transformed Score) = [(Raw Score) - 5] * 4.|Baseline to 8 weeks|||units on a scale||Standard Error|Least Squares Mean
775577|NCT00758459|Secondary|6-minute Walk Test|Change from baseline to end of treatment|Before treatment and after 6 weeks of treatment|||m||Full Range|Mean
775578|NCT00758459|Secondary|Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Night Time Awakenings|Change in night time awakenings from average during run-in to average during the last 4 w of treatment, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe)|Daily during run-in and treatment|||Score on scale||Full Range|Mean
775579|NCT00758459|Secondary|Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Cough Score|Change in COPD symptoms, cough score from average during run-in to average during the last 4 w of treatment, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe)|Daily during run-in and treatment|||Scores on a Scale||Full Range|Mean
775580|NCT00758459|Secondary|Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Chest Tightness|Change in COPD symptom, chest tightness from average during run-in to average during the last 4 w of treatment, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe)|Daily during run-in and treatment|||Scores on a Scale||Full Range|Mean
775581|NCT00758459|Secondary|Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Breathlessness|Change in COPD symptom, Breathlessness from average during run-in to average during the last 4 w of treatment. 5-point Likert-type scale, ranging from 0 (none) to 4 (severe)|Daily during run-in and treatment|||Score on scale||Full Range|Mean
775582|NCT00758459|Secondary|Clinical Chronic Obstructive Pulmonary Disease (COPD) Questionnaire(CCQ) Total|Change from baseline to end of treatment in score , The total scores vary between 0 (never/not limited at all) to 6 (almost all the time/totally limited)|Before treatment and after 1, 2, 4 and 6 weeks of treatment|||Score on scale||Full Range|Mean
775583|NCT00758459|Secondary|Peak Expiratory Flow (PEF) Evening|Change in PEF from average during run-in to average during the last 4 w of treatment|Daily during run-in and treatment|||L/min||Full Range|Mean
775584|NCT00758459|Secondary|Peak Expiratory Flow (PEF) Morning|Change in PEF from average during run-in to average during the last 4 w of treatment|Daily during run-in and treatment|||L/min||Full Range|Mean
775585|NCT00758459|Secondary|Forced Expiratory Flow (FEF)25−75%|Change in FEF from baseline to end of treatment|Before treatment and after 1, 2, 4 and 6 weeks of treatment|||L/s||Full Range|Mean
775586|NCT00758459|Secondary|Inspiratory Capacity (IC)|Change in IC from baseline to end of treatment|Before treatment and after 1, 2, 4 and 6 weeks of treatment|||L||Full Range|Mean
775587|NCT00758459|Secondary|Vital Capacity (VC)|Change in VC from baseline to end of treatment|Before treatment and after 1, 2, 4 and 6 weeks of treatment|||L||Full Range|Mean
775588|NCT00758459|Secondary|Forced Vital Capacity (FVC)|Change in FVC from baseline to end of treatment|Before treatment and after 1, 2, 4 and 6 weeks of treatment|||L||Full Range|Mean
775589|NCT00758459|Secondary|Forced Expiratory Volume in 1 Second (FEV1)|Change in FEV1 from baseline to end of treatment|Before treatment and after 1, 2, 4 and 6 weeks of treatment|||L||Full Range|Mean
775590|NCT00758459|Primary|Incidence of Adverse Events|Number of patients who had an Adverse Event|all study visits|||Participants|||Number
775591|NCT00758485|Secondary|Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.8|Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (height) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (a percentage that is expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB, with a higher ratio indicating a greater recovery from NMB.|From Start of IMP Administration to Recovery of the T4/T1 Ratio to 0.8 (estimated from ~2 minutes up to ~80 minutes)|The ITT Population consisted of all participants who received either Sugammadex or Placebo and had at least one efficacy measurement. Imputed recovery times were used in cases of missing times.||minutes||95% Confidence Interval|Geometric Mean
775610|NCT00758498|Secondary|Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Day 3|"The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep).
The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS mean score as measured on day 3, collected only at bedtime, is reported here."|Day 3 bedtime|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement||Units on a scale||Standard Deviation|Mean
775593|NCT00758485|Primary|Time From Start of Administration of Investigational Medicinal Product (IMP, Sugammadex or Placebo) to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9|Neuromuscular functioning was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (height) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (a percentage that is expressed as a decimal of up to 1.0) indicates the extent of recovery from neuromuscular blockade (NMB), with a higher ratio indicating a greater recovery from NMB. In this study, twitch responses were recorded until the T4/T1 Ratio reached >=0.9, the minimum acceptable ratio that indicated complete recovery from NMB. A shorter time to recovery of the T4/T1 Ratio >=0.9 indicates a faster recovery from NMB.|From Start of IMP Administration to Recovery of the T4/T1 Ratio to 0.9 (estimated from ~2 minutes up to ~90 minutes)|The Intent-to-Treat (ITT) Population consisted of all participants who received either Sugammadex or Placebo and had at least one efficacy measurement. Imputed recovery times were used in cases of missing times.||minutes||95% Confidence Interval|Geometric Mean
775594|NCT00758498|Secondary|Mean Change From Baseline to Endpoint in Wake Time After Sleep Onset as Measured by Nocturnal Polysomnography|Nocturnal Polysomnography records normal and abnormal physiological activity during an entire night's sleep. It documents the adequacy of sleep, including frequency duration, and total amount of stage 1-2, stage 3-4 (slow wave sleep), rapid eye movement sleep, and apnea/hypopnea index. Data presented here represents the difference in mean wake time after sleep onset (time spent awake from sleep onset to final awakening) from Baseline to Day 2 as recorded by nocturnal polysomnography.|Baseline and Day 2 (Endpoint)|Safety analysis population defined as all subjects who had at least one dose of study drug and underwent nocturnal polysomnography at Baseline and Day 2||Minutes||Standard Deviation|Mean
775595|NCT00758498|Secondary|Mean Change in Sleep Efficiency From Baseline To Endpoint as Measured by Nocturnal Polysomnography|Nocturnal Polysomnography records normal and abnormal physiological activity during an entire night's sleep. It documents the adequacy of sleep, including frequency duration, and total amount of stage 1-2, stage 3-4 (slow wave sleep), rapid eye movement sleep, and apnea/hypopnea index. Data presented here represents the difference in mean sleep efficiency from Baseline to Day 2 as recorded by nocturnal polysomnography. Sleep efficiency is defined as the ratio of time spent asleep (total sleep time) to the amount of time in bed.|Baseline and Day 2 (Endpoint)|Safety analysis population defined as all subjects who had at least one dose of study drug and underwent nocturnal polysomnography at Baseline and Day 2||Percent||Standard Deviation|Mean
775596|NCT00758498|Secondary|Mean Change From Baseline to Endpoint in Latency to Persistent Sleep as Measured by Nocturnal Polysomnography|Nocturnal Polysomnography records normal and abnormal physiological activity during an entire night's sleep. It documents the adequacy of sleep, including frequency duration, and total amount of stage 1-2, stage 3-4 (slow wave sleep), rapid eye movement sleep, and apnea/hypopnea index. Data presented here represents the difference in mean latency to persistent sleep from Baseline to Day 2 as recorded by nocturnal polysomnography.|Baseline and Day 2 (Endpoint)|Safety analysis population defined as all subjects who had at least one dose of study drug and underwent nocturnal polysomnography at Baseline and Day 2||Minutes||Standard Deviation|Mean
775597|NCT00758498|Secondary|Mean Change From Baseline to Endpoint in Total Sleep Time as Measured by Nocturnal Polysomnography|Nocturnal Polysomnography records normal and abnormal physiological activity during an entire night's sleep. It documents the adequacy of sleep, including frequency duration, and total amount of stage 1-2, stage 3-4 (slow wave sleep), rapid eye movement sleep, and apnea/hypopnea index. Data presented here represents the difference in mean total sleep time overnight from Baseline to Day 2 as recorded by nocturnal polysomnography.|Baseline and Day 2 (Endpoint)|Safety analysis population defined as all subjects who had at least one dose of study drug and underwent nocturnal polysomnography at Baseline and Day 2||Minutes||Standard Deviation|Mean
775598|NCT00758498|Secondary|Change in State and Trait Anxiety Inventory Total Score From Baseline to Day 3|The State and Trait Anxiety Inventory is a validated self-reporting instrument used to assess anxiety in adults. The inventory consists of 2 scales: state anxiety, which evaluates how the subject feels currently (transient anxiety), and trait anxiety, which evaluates how the subject feels generally (general tendency towards anxiety). Each scale consists of 20 questions, and a higher score indicates greater anxiety. Scores range from 20 (no anxiety) to 80 (maximum anxiety). The change in total score from Baseline to Day 3 is presented here.|Day 3|Safety analysis population defined as all subjects who had at least one dose of study drug and completed the State and Trait Anxiety Inventory Assessment at Baseline and Day 3||Units on a scale||Standard Deviation|Mean
775599|NCT00758498|Secondary|Change in State and Trait Anxiety Inventory Total Score From Baseline to Day 2|The State and Trait Anxiety Inventory is a validated self-reporting instrument used to assess anxiety in adults. The inventory consists of 2 scales, state anxiety, which evaluates how the subject feels currently (transient anxiety), and trait anxiety, which evaluates how the subject feels generally (general tendency towards anxiety). Each scale consists of 20 questions, and a higher score indicates greater anxiety. Scores range from 20 (no anxiety) to 80 (maximum anxiety). The change in total score from Baseline to Day 2 is presented here.|Day 2|Safety analysis population defined as all subjects who had at least one dose of study drug and completed the State and Trait Anxiety Inventory Assessment at Baseline and Day 2||Units on a scale||Standard Deviation|Mean
775600|NCT00758498|Secondary|Change in State and Trait Anxiety Inventory Total Score From Baseline to Day 1|The State and Trait Anxiety Inventory is a validated self-reporting instrument used to assess anxiety in adults. The inventory consists of 2 scales, state anxiety, which evaluates how the subject feels currently (transient anxiety), and trait anxiety, which evaluates how the subject feels generally (general tendency towards anxiety). Each scale consists of 20 questions, and a higher score indicates greater anxiety. Scores range from 20 (no anxiety) to 80 (maximum anxiety). The change in total score from Baseline to Day 1 is presented here.|Day 1|Safety analysis population defined as all subjects who had at least one dose of study drug and completed the State and Trait Anxiety Inventory Assessment at Baseline and Day 1||Units on a scale||Standard Deviation|Mean
775623|NCT00758576|Primary|Uncorrected Near Visual Acuity|Binocular Near Visual Acuity measured in decimal visual acuity. Decimal visual acuity is the normal method to measure visual acuity in Japan. A higher decimal visual acuity value indicates better visual acuity. 0.5 in decimal visual acuity means 20/40 in Snellen fraction.|1 year after surgery|One patient dropped out after the visit 6 months following surgery but before the 1 year visit.||Decimal Visual Acuity||Full Range|Mean
775601|NCT00758498|Secondary|Change in State and Trait Anxiety Inventory Total Score From Baseline to Endpoint|The State and Trait Anxiety Inventory is a validated self-reporting instrument used to assess anxiety in adults. The inventory consists of 2 scales, state anxiety, which evaluates how the subject feels currently (transient anxiety), and trait anxiety, which evaluates how the subject feels generally (general tendency towards anxiety). Each scale consists of 20 questions, and a higher score indicates greater anxiety. Scores range from 20 (no anxiety) to 80 (maximum anxiety). The change in total score from Baseline to endpoint is presented here.|Endpoint defined as either Day 3 or last observation after baseline|Safety analysis population defined as all subjects who had at least one dose of study drug and one State and Trait Anxiety Inventory Assessment after Baseline||Units on a scale||Standard Deviation|Mean
775602|NCT00758498|Secondary|Mean Patient Global Impression of Severity of General Condition Ratings at Day 3|"The PGI-S rating scale is the patient's assessment of general condition. The subject rates their overall condition according to the 7 following categories: 1=normal (no sign of illness), 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, and 7=among the most extremely ill. The term ill refers to symptoms of jet lag including excessive sleepiness, irritability, malaise, gastrointestinal disturbance, and poor performance. The least squares mean of PGI-S ratings at day 3 is presented here."|Day 3|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement||units on a scale||Standard Error|Least Squares Mean
775603|NCT00758498|Secondary|Mean Patient Global Impression of Severity of General Condition Ratings at Day 2|"The PGI-S rating scale is the patient's assessment of general condition. The subject rates their overall condition according to the 7 following categories: 1=normal (no sign of illness), 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, and 7=among the most extremely ill. The term ill refers to symptoms of jet lag including excessive sleepiness, irritability, malaise, gastrointestinal disturbance, and poor performance. The least squares mean of PGI-S ratings at day 2 is presented here."|Day 2|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement||units on a scale||Standard Error|Least Squares Mean
775604|NCT00758498|Secondary|Mean Patient Global Impression of Severity of General Condition Ratings at Day 1|"The PGI-S rating scale is the patient's assessment of general condition. The subject rates their overall condition according to the 7 following categories: 1=normal (no sign of illness), 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, and 7=among the most extremely ill. The term ill refers to symptoms of jet lag including excessive sleepiness, irritability, malaise, gastrointestinal disturbance, and poor performance. The least squares mean of PGI-S ratings at day 1 is presented here."|Day 1|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement||units on a scale||Standard Error|Least Squares Mean
775605|NCT00758498|Secondary|Mean Patient Global Impression of Severity of General Condition Ratings at Baseline|"The PGI-S rating scale is the patient's assessment of general condition. The subject rates their overall condition according to the 7 following categories: 1=normal (no sign of illness), 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, and 7=among the most extremely ill. The term ill refers to symptoms of jet lag including excessive sleepiness, irritability, malaise, gastrointestinal disturbance, and poor performance. The least squares mean of PGI-S ratings at Baseline is presented here."|Baseline, prior to start of study drug dosing|Full analysis set defined as all subjects who received at least one dose of study drug and had a baseline efficacy measurement||Units on a scale||Standard Deviation|Mean
775606|NCT00758498|Secondary|Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Tests (MSLT) at Day 3|MSLT measures likelihood of falling asleep. Mean Sleep Latency measures the time to fall asleep (in minutes). On Treatment Days 1 and 2 the subject was instructed on 4 occasions to attempt to fall asleep. Each MSLT nap continued until 3 consecutive 30-sec epochs of stage 1 sleep were reached, or any 30 sec epoch of stage 2, 3, 4 or rapid eye movement sleep was reached. Each nap was terminated after 20 min if no sleep occurred. Sleep latency was measured from lights out to first epoch scored as sleep. Least Squares Mean sleep latency from the MSLT at day 3 is presented here.|Day 3|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement||Minutes||Standard Error|Least Squares Mean
775607|NCT00758498|Secondary|Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Tests (MSLT) at Day 2|MSLT measures likelihood of falling asleep. Mean Sleep Latency measures the time to fall asleep (in minutes). On Treatment Days 1 and 2 the subject was instructed on 4 occasions to attempt to fall asleep. Each MSLT nap continued until 3 consecutive 30-sec epochs of stage 1 sleep were reached, or any 30 sec epoch of stage 2, 3, 4 or rapid eye movement sleep was reached. Each nap was terminated after 20 min if no sleep occurred. Sleep latency was measured from lights out to first epoch scored as sleep. Least Squares Mean sleep latency from the MSLT at day 2 is presented here.|Day 2|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement||Minutes||Standard Error|Least Squares Mean
775608|NCT00758498|Secondary|Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Tests (MSLT) at Day 1|MSLT measures likelihood of falling asleep. Mean Sleep Latency measures the time to fall asleep (in minutes). On Treatment Days 1 and 2 the subject was instructed on 4 occasions to attempt to fall asleep. Each MSLT nap continued until 3 consecutive 30-sec epochs of stage 1 sleep were reached, or any 30 sec epoch of stage 2, 3, 4 or rapid eye movement sleep was reached. Each nap was terminated after 20 min if no sleep occurred. Sleep latency was measured from lights out to first epoch scored as sleep. Least squares mean sleep latency from the MSLT at day 1 is presented here.|Day 1|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement||Minutes||Standard Error|Least Squares Mean
775609|NCT00758498|Secondary|Mean Ratings From the Mean Sleep Latency of the Multiple Sleep Latency Tests (MSLT) at Baseline|MSLT measures the likelihood of falling asleep. Mean Sleep Latency measures the time to fall asleep (in minutes). On Treatment Days 1 and 2 the subject was instructed on 4 occasions to attempt to fall asleep. Each MSLT nap continued until 3 consecutive 30-sec epochs of stage 1 sleep were reached, or any 30 sec epoch of stage 2, 3, 4 or rapid eye movement sleep was reached. Each nap was terminated after 20 min if no sleep occurred. Sleep latency was measured from lights out to first epoch scored as sleep. Mean sleep latency from the MSLT at Baseline (Screening Day 2) is presented here.|Baseline defined as Screening Visit 2 within 8 weeks prior to Treatment Day 1|||Minutes||Standard Deviation|Mean
775611|NCT00758498|Secondary|Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Day 2|"The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep).
The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS mean score as measured on day 2, collected only at bedtime, is reported here."|Day 2 bedtime|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement||Units on a scale||Standard Deviation|Mean
775612|NCT00758498|Secondary|Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Day 1|"The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep).
The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS mean score as measured on day 1, collected only at bedtime, is reported here."|Day 1 bedtime|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement||Units on a scale||Standard Deviation|Mean
775613|NCT00758498|Secondary|Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Baseline|"The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep).
The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS mean score as measured at Baseline, collected at bedtime, is reported here."|Baseline prior to starting study medication|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement||Units on a scale||Standard Deviation|Mean
775614|NCT00758498|Secondary|Mean Scores From the Karolinska Sleepiness Scale (KSS) at Day 3|"The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep).
The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS least squares mean score as measured on day 3 is reported here."|Day 3|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement||Units on a scale||Standard Error|Least Squares Mean
775615|NCT00758498|Secondary|Mean Scores From the Karolinska Sleepiness Scale (KSS) at Day 2|"The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep).
The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS Least squares mean score as measured on day 2 is reported here."|Day 2|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement||Units on a scale||Standard Error|Least Squares Mean
775616|NCT00758498|Secondary|Mean Scores From the Karolinska Sleepiness Scale (KSS) at Day 1|"The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep).
The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS least squares mean score across day 1 is reported here."|Day 1|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement||Units on a scale||Standard Error|Least Squares Mean
775617|NCT00758498|Secondary|Average of Scores Across Days 1 and 2 in the Karolinska Sleepiness Scale (KSS)|"The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep).
The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS least squares mean score across days 1 and 2 are reported here."|Days 1 and 2|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement||Units on a scale||Standard Error|Least Squares Mean
775618|NCT00758498|Primary|Average of Patient Global Impression of Severity (PGI-S) of General Condition Ratings Across Days 1 and 2|"The PGI-S rating scale is the patient's assessment of their general condition. The subject rates their overall condition according to the 7 following categories: 1=normal (no sign of illness), 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, and 7=among the most extremely ill. The term ill refers here to any symptoms of jet lag and overall feeling. Symptoms may include sleepiness, irritability, malaise, gastrointestinal disturbance, and level of performance. The average of PGI-S ratings across days 1 and 2 are presented here."|Days 1 and 2|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement||Units on a scale||Standard Error|Least Squares Mean
775619|NCT00758498|Primary|Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Test (MSLT)- Average of Four Scheduled Naps Across Days 1 and 2|MSLT is an assessment that measures likelihood of falling asleep. Mean Sleep Latency measures the time to fall asleep. On Treatment Days 1 and 2 the subject was instructed on 4 occasions to attempt to fall asleep. Each MSLT nap continued until 3 consecutive 30-second epochs of stage 1 sleep were reached, or any 30 second epoch of stage 2, 3, 4 or rapid eye movement sleep was reached. Each nap was terminated after 20 minutes if no sleep occured. Average sleep latency for the 4 naps was tabulated across days 1 and 2. Sleep latency was measured from lights out to first epoch scored as sleep.|Days 1 and 2|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement||Minutes||Standard Error|Least Squares Mean
775620|NCT00758550|Secondary|Questionnaire Results|Results of questionnaire rating the quality of distance vision without glasses or contact lenses. Measured on a scale of 0 to 6 (0 = worst, 6 = best).|6 Months|||Units on a scale||Standard Error|Mean
775621|NCT00758550|Primary|Uncorrected Visual Acuity (UCVA)|Uncorrected Visual Acuity (UCVA) from surgery measured in logMAR. LogMAR is the “logarithm of the minimum angle of resolution”. A lower logMAR value indicates better visual acuity.|6 Months after surgery|||logMAR||Standard Deviation|Mean
775622|NCT00758563|Primary|Mean Gingival Plaque Units|Scale 0 to 100% of tooth gingival margin covered by plaque. (0=no plaque, 100%=100% of the tooth's gingival margin is covered in plaque).|1 day|||Units on a scale||Standard Deviation|Mean
775624|NCT00758576|Primary|Uncorrected Distance Visual Acuity|Binocular Uncorrected Dinstance Visual Acuity measured in decimal visual acuity. Decimal visual acuity is the normal method to measure visual acuity in Japan. A higher decimal visual acuity value indicates better visual acuity. 0.5 in decimal visual acuity means 20/40 in Snellen fraction.|1 year after surgery|One patient dropped out after the visit 6 months following surgery but before the 1 year visit.||Decimal Visual Acuity||Full Range|Mean
775625|NCT00758576|Primary|Uncorrected Intermediate Visual Acuity|Binocular Uncorrected Intermediate Visual Acuity, measured at 1 meter and 50 centimeters measured in decimal visual acuity. Decimal visual acuity is the normal method to measure visual acuity in Japan. A higher decimal visual acuity value indicates better visual acuity. 0.5 in decimal visual acuity means 20/40 in Snellen fraction.|1 year after surgery|One patient dropped out after the visit 6 months following surgery but before the 1 year visit.||Decimal Visual Acuity||Full Range|Mean
775626|NCT00758589|Secondary|Adverse Event (AE)|Number of patients reporting at least one event|4 weeks|||Participants|||Number
775627|NCT00758589|Secondary|Asthma Control Questionnaire 5 Items (ACQ5)|Mean ACQ5 score during the treatment period (mean value at Week 4). Scores range from 0 (good) to 6 (poor control).|Week 4|The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.||Scores on a scale||Full Range|Mean
775628|NCT00758589|Secondary|Forced Vital Capacity (FVC) at the Clinic|Mean FVC during the treatment period (mean value at Week 4)|Week 4|The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.||L||Standard Deviation|Mean
775629|NCT00758589|Secondary|Forced Expiratory Volume in 1 Second (FEV1) at the Clinic|Mean FEV1 during the treatment period (mean value at Week 4)|Week 4|The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.||L||Standard Deviation|Mean
775630|NCT00758589|Secondary|Reliever Free Day|Mean percentage of reliever free days during the treatment period (mean of the last 2 weeks of the treatment period). A reliever free day is defined as a day and a night with no use of as-needed medication.|Week 4|The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.||Percentage of days||Standard Deviation|Mean
775631|NCT00758589|Secondary|Symptom Free Day|Mean percentage of symptom free days during the treatment period (mean of the last 2 weeks of the treatment period). A symptom-free day is defined as a day and a night with no asthma symptoms and a day and night with no awakenings due to asthma symptoms.|Week 4|The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.||Percentage of days||Standard Deviation|Mean
775632|NCT00758589|Secondary|Asthma Control Day|Mean percentage of asthma control days during the treatment period (mean of the last 2 weeks of the treatment period). An asthma control day is defined as a symptom-free day with no use of reliever medication during day and night. A symptom-free day is defined as a day and a night with no asthma symptoms and a day and night with no awakenings due to asthma symptoms.|Week 4|The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.||Percentage of days||Standard Deviation|Mean
775633|NCT00758589|Secondary|Awakenings|Mean percentage of awakenings due to asthma symptoms during the treatment period (mean of the last 2 weeks of the treatment period)|Week 4|The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.||Percentage of days||Standard Deviation|Mean
775634|NCT00758589|Secondary|Day-time Asthma Symptom Score|Mean day-time asthma symptom score during the treatment period (mean of the last 2 weeks of the treatment period). Scores range from 0 (none) to 3 (bad).|Week 4|The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.||Scores on a scale||Standard Deviation|Mean
775635|NCT00758589|Secondary|Night-time Asthma Symptom Score|Mean night-time asthma symptom score during the treatment period (mean of the last 2 weeks of the treatment period). Scores range from 0 (none) to 3 (bad).|Week 4|The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.||Scores on a scale||Standard Deviation|Mean
775636|NCT00758589|Secondary|Total Use of Reliever|Mean total reliever use during the treatment period (mean of the last 2 weeks of the treatment period)|Week 4|The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.||Number of inhalations per day||Standard Deviation|Mean
775637|NCT00758589|Secondary|Evening Forced Expiratory Volume in 1 Second (eFEV1)|Mean eFEV1 during the treatment period (mean of the last 2 weeks of the treatment period)|Week 4|The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.||L||Standard Deviation|Mean
775638|NCT00758589|Secondary|Morning Forced Expiratory Volume in 1 Second (mFEV1)|Mean mFEV1 during the treatment period (mean of the last 2 weeks of the treatment period)|Week 4|The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.||L||Standard Deviation|Mean
775639|NCT00758589|Secondary|Evening Peak Expiratory Flow (ePEF)|Mean ePEF during the treatment period (mean of the last 2 weeks of the treatment period)|Week 4|The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.||L/min||Standard Deviation|Mean
775640|NCT00758589|Primary|Morning Peak Expiratory Flow (mPEF)|Mean mPEF during the treatment period (mean of the last 2 weeks of the treatment period)|Week 4|The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.||L/min||Standard Deviation|Mean
775641|NCT00758602|Secondary|Glomerular Filtration Rate (GFR) (mL/Min)|The mean GFR values in mL/min at BL, Weeks 2, 4, 13, 26, 39, and 52.|BL, Weeks 2, 4, 13, 26, 39, and 52|ITT population; n=number of participants assessed for the specified parameter at a given visit.||mL/min||Standard Deviation|Mean
775644|NCT00758602|Secondary|Percentage of Participants With Treatment Failure at 12 Months Post-Transplant|Treatment failure was defined by the occurrence of any of the following: use of additional maintenance immunosuppressive medication not specified in the assigned treatment group; discontinuation of any of the assigned immunosuppressants for more than 14 consecutive days or 30 cumulative days; graft loss or return to chronic dialysis; or death.|Month 12|ITT population||percentage of participants|||Number
775645|NCT00758602|Secondary|Time to First Acute Rejection Post-Transplant|The median time, in days, between randomization and acute rejection.|BL, Weeks 2, 4, 13, 26, 39, and 52|ITT population||days||95% Confidence Interval|Median
775646|NCT00758602|Secondary|Time to First Acute Rejection Post-Transplant - Number of Participants With an Event||BL, Weeks 2, 4, 13, 26, 39, and 52|ITT population||participants|||Number
775647|NCT00758602|Secondary|Percentage of Participants Experiencing Acute Rejection, Graft Loss, or Death at 6 and 12 Months Post-Transplant||Months 6 and 12|ITT population||percentage of participants|||Number
775648|NCT00758602|Primary|Glomerular Filtration Rate (GFR) at Month 12 After Transplantation|GFR was determined using the Cockcroft-Gault formula to calculate the creatinine clearance, at Month 12 after renal transplantation. For males, creatinine clearance [milliliters per minute (mL/min)] = [(140 minus age) multiplied by (*) (body weight in kg) divided by [72 * serum creatinine mg per deciliter (mg/dL)]. For females, creatinine clearance (mL/min) = 0.85 * [(140 minus age) * (body weight in kg)] divided by [72 * serum creatinine (mg/dL)].|Month 12|ITT population; only participants with assessable parameters for the calculation of GFR were included in the analysis.||mL/min||Standard Deviation|Mean
775649|NCT00758602|Primary|Chronic Allograft Damage Index (CADI) Score at Month 12 After Transplantation|CADI scoring was defined for 6 histological categories: interstitial inflammatory cell infiltration (0 equals (=) no or mild inflammation, 1=approximately (~)25 percent (%) cell infiltration, 2=26-50% cell infiltration, and 3=greater than (>)50% cell infiltration); interstitial fibrosis (0=none, 1=~25% interstitial affected, 2=26-50% interstitial affected, and 3=>50% interstitial affected); tubular atrophy (0=none, 1=~15% proximal tubular atrophy [PTA], 2=16-30% PTA, and 3=>30% PTA); mesangial matrix proliferation (MMP; 0=none, 1=25% non-glomerulosclerosis [NGS] combined with moderate MMP, 2=25-50% NGS combined with MMP, and 3=>50% NGS combined with MMP); glomerular sclerosis (0=none, 1=~15% glomerulus affected, 2=16-50% glomerulus affected, and 3=>50% glomerulus affected); endothelial proliferation (EP; 0=none, 1=EP to less than (<)25% remaining artery/small artery membrane [RA/SAM], 2=EP to 26-50% [RA/SAM], and 3=>50% [RA/SAM]). CADI score was the sum of the 6 histological findings.|Month 12|ITT population; only participants with biopsy confirmed CADI assessment 12 months post-transplantation were included in the analysis.||score on a scale||Standard Deviation|Mean
775650|NCT00758667|Secondary|Compare Number of Patients With Adverse Events in the Mesna Group vs the Standard of Care||one year|||participants|||Number
775651|NCT00758667|Primary|Compare Number of Patients With Capsular Contracture in Mesna Group vs Standard of Care||one year|||participants|||Number
775652|NCT00758680|Primary|Number of Participants Who Discontinued Treatment Due to an AE|An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the study treatment, was also an adverse event.|From Day 1 through the end of poststudy period (up to Day 25)|All Participants as Treated (APaT); All participants who received at least one dose of the investigational drug||participants|||Number
775653|NCT00758680|Secondary|Least Squares Mean Change From Baseline in 24-Hour Weighted Mean Glucose (WMG)|Plasma glucose concentration was determined using a glucometer and measured before drug was given to establish a baseline fasting plasma glucose concentration. Plasma glucose concentrations were then measured every ~30 minutes over a 24 hour period after the Day 1 dose (First Dosing Day) and after the Day 10 dose (Last Dosing Day) to obtain a weighted mean average value for Day 1 and for Day 10. Results were expressed as the change from baseline to the Day 1 weighted average (First Dosing Day), and as the change from baseline to the Day 10 weighted average (Last Dosing Day).|Day -1 (pre-dose baseline), Day 1 (First Dosing Day), Day 10 (Last Dosing Day)|Per-Protocol Population; subset of participants who complied with the protocol sufficiently in terms of considerations as exposure to treatment, availability of measurements and absence of major protocol violations.||mg/dL||Standard Deviation|Least Squares Mean
775654|NCT00758680|Primary|Number of Participants Experiencing Adverse Events (AEs) On Study|An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the study treatment, was also an adverse event.|From Day 1 through the end of poststudy period (up to Day 25)|All Participants as Treated (APaT); All participants who received at least one dose of the investigational drug||participants|||Number
775655|NCT00758706|Secondary|Change From Baseline in COPD Symptoms, Night Time Awakenings at Average of Last 4 Week Treatment|Change from baseline reflects the average of last 4 week on treatment (Week 1, Week 2, Week 4 and Week 6) minus the baseline value. Baseline is the mean of the last 10 days of data during run-in. Score vary between 0 (None) to 4 (Almost Constant).|Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)|Full analysis set||Score on scale||Full Range|Mean
775656|NCT00758706|Secondary|Change From Baseline in COPD Symptoms, Cough Score at Average of Last 4 Week Treatment|Change from baseline reflects the average of last 4 week on treatment (Week 1, Week 2, Week 4 and Week 6) minus the baseline value. Baseline is the mean of the last 10 days of data during run-in. Score vary between 0 (None) to 4 (Almost Constant).|Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)|Full analysis set||Score on scale||Full Range|Mean
775657|NCT00758706|Secondary|Change From Baseline in COPD Symptoms, Chest Tightness at Average of Last 4 Week Treatment|Change from baseline reflects the average of last 4 week on treatment (Week 1, Week 2, Week 4 and Week 6) minus the baseline value. Baseline is the mean of the last 10 days of data during run-in. Score vary between 0 (None) to 4 (Severe).|Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)|Full analysis set||Score on scale||Full Range|Mean
787795|NCT00845663|Secondary|Injection Questionnaire Per Formulation and Per Time Point - Afraid of Having Injections|Categorized answer ranges from not at all to extremely.|Before and 24 hours post-dose|Intent-to-treat population||Participants|||Number
775658|NCT00758706|Secondary|Change From Baseline in COPD Symptoms, Breathlessness at Average of Last 4 Week Treatment|Change from baseline reflects the average of last 4 week on treatment (Week 1, Week 2, Week 4 and Week 6) minus the baseline value. Baseline is the mean of the last 10 days of data during run-in. Score vary between 0 (None) to 4 (Severe).|Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)|Full analysis set||Score on scale||Full Range|Mean
775659|NCT00758706|Secondary|Change From Baseline in Clinical COPD Questionnaire(CCQ) Total|Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value. The total scores vary between 0 (never/not limited at all) to 6 (almost all the time/totally limited)|Baseline and Week 6|Full analysis set||Score on scale||Full Range|Mean
775660|NCT00758706|Secondary|Change From Baseline in Peak Expiratory Flow (PEF) Evening at Average of Last 4 Week Treatment|Change from baseline reflects the average of last 4 week on treatment (Week 1, Week 2, Week 4 and Week 6) minus the baseline value. Baseline is the mean of the last 10 days of data during run-in.|Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)|Full analysis set||L/min||Full Range|Mean
775661|NCT00758706|Secondary|Change From Baseline in Peak Expiratory Flow (PEF) Morning at Average of Last 4 Week Treatment|Change from baseline reflects the average of last 4 week on treatment (Week 1, Week 2, Week 4 and Week 6) minus the baseline value. Baseline is the mean of the last 10 days of data during run-in.|Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)|Full analysis set||L/min||Full Range|Mean
775662|NCT00758706|Secondary|Change From Baseline in Forced Expiratory Flow (FEF) 25−75% at Week 6|Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value.|Baseline and Week 6|Full analysis set completed at week 6||L/s||Full Range|Mean
775663|NCT00758706|Secondary|Change From Baseline in Inspiratory Capacity (IC) at Week 6|Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value.|Baseline and Week 6|Full analysis set completed at week 6||L||Full Range|Mean
775664|NCT00758706|Secondary|Change From Baseline in Vital Capacity (VC) at Week 6|Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value.|Baseline and Week 6|Full analysis set completed at week 6||L||Full Range|Mean
775665|NCT00758706|Secondary|Change From Baseline in Forced Vital Capacity (FVC) at Week 6|Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value.|Baseline and Week 6|Full analysis set completed at week 6||L||Full Range|Mean
775666|NCT00758706|Secondary|Change From Baseline in Forced Expiratory Volume (FEV1) at Week 6|Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value.|Baseline and Week 6|Full analysis set completed at week 6||L||Full Range|Mean
775667|NCT00758706|Secondary|Incidence of Adverse Events|Number of patients who had an AE|all study visits|||Participants|||Number
775668|NCT00758706|Primary|Ratio of Total Urine Desmosine at Week 6 to Baseline|Ratio reflects Total Urine Desmosine at week 6 value divide by baseline value. Baseline is visit 3(Randomization) value.|Baseline and Week 6|Full analysis set excluded participants without baseline or post-baseline data.||ratio||Full Range|Mean
775669|NCT00758706|Primary|Ratio of Sputum Total Cells at Week 6 to Baseline|Ratio reflects Sputum Total Cells at week 6 value divide by baseline value. Baseline is geometric mean of Visit 2 (last value during run-in) and Visit 3 (Randomization).|Baseline and Week 6|Full analysis set excluded participants without baseline or post-baseline data.||ratio||Full Range|Mean
775670|NCT00758706|Primary|Ratio of TNF Alpha at Week 6 to Baseline|Ratio reflects Sputum Tumor Necrosis Factor alpha (TNF alpha) at week 6 value divide by baseline value. Baseline is geometric mean of Visit 2 (last value during run-in) and Visit 3 (Randomization).|Baseline and Week 6|Full analysis set excluded participants without baseline or post-baseline data.||ratio||Full Range|Mean
775671|NCT00758745|Primary|Posterior Capsule Opacification (PCO)|Development of PCO using the EPCO Score. The EPCO score incorporates planimetric & grading assessments. The density of the opacification behind the Intraocular Lens (IOL) is graded clinically as follows: 0=No detectable opacification; 1=Minimal detectable opacification; 2=mild detectable opacification; 3=moderate detectable opacification; 4=severe detectable opacification. The individual PCO score is calculated by multiplying the opacification grade by the fraction of capsule area involved behind the IOL optic. The selection process and grading of areas are subjective.|Up to 3 years|||Units on a scale||Standard Deviation|Mean
775672|NCT00758758|Primary|Neck Disability Index (NDI)|"The Neck Disability Index (NDI) is an instrument used for testing self-rated disability in neck pain patients. The Neck Disability Index (NDI) consists of 10 questions, each with a score up to 5, for a total score of 50. The lower the score, the less self-rated disability.
NDI scoring:
0 – 4 = No disability
5 – 14 = Mild disability
15 – 24 = Moderate disability
25 – 34 = Severe disability
35 or over = Complete disability"|12 Months|||units on a scale||Standard Deviation|Mean
775673|NCT00758758|Primary|Overall Clinical Success (NDI, Fusion, Additional Surgical Procedures)|Success was defined as an improvement in patient functional capability using the Neck Disability Index (NDI) by at least 10% as compared to the pre-operative evaluation and Radiographic evidence of fusion (< 3mm translation; < 5° angular motion and absence of radiolucent lines around ≥ 50% of the device)and A comparison of the incidence of intraoperative and postoperative complications which resulted in additional surgical procedures of revision, removal or supplemental fixation at 12 months|12 Months|||participants|||Number
775674|NCT00758771|Primary|Shear Rheology|Baseline measure of sputum shear rheology|Cross-sectional|||Pascal||Standard Error|Mean
775675|NCT00758836|Primary|Number of Participants Experiencing Adverse Events Within 14 Days Post-dose (Count ≥4 in One or More Treatment Groups)|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.|Up to 14 days post-dose|All participants as treated (one participant assigned to the Telcagepant 280 mg arm only took the placebo tablet and is included in the Placebo arm for adverse event reporting).||participants|||Number
775676|NCT00758836|Primary|Number of Participants Experiencing Adverse Events Within 48 Hours Post-dose (Count ≥4 in One or More Treatment Groups)|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.|Up to 48 hours post-dose|All participants as treated (one participant assigned to the Telcagepant 280 mg arm only took the placebo tablet and is included in the Placebo arm for adverse event reporting).||Participants|||Number
775677|NCT00758836|Secondary|Percentage of Participants With Pain Relief at 2 Hours Post-dose.|Pain severity was rated by the participants in a paper diary by grade; Grade 0 (no pain), Grade 1 (mild pain), Grade 2 (moderate pain), and Grade 3 (severe pain). Pain relief was defined as a reduction in pain severity from moderate to severe migraine headache (Grade 2 or 3) to mild or none (Grade 1 or 0).|2 hours post-dose|The FAS comprised participants who were treated and had a baseline assessment and at least one post-dose assessment up to or including the 2-hour time point. Missing data were imputed by using a Last Observation Carried Forward (LOCF) approach; baseline values were not carried forward to impute the missing post-treatment data.||Percentage of Participants|||Number
775678|NCT00758836|Primary|Percentage of Participants With Pain Freedom at Two Hours Post-dose|Pain severity was rated by the participants in a paper diary by grade; Grade 0 (no pain), Grade 1 (mild pain), Grade 2 (moderate pain), and Grade 3 (severe pain). Pain freedom was defined as a reduction in pain severity from moderate to severe migraine headache (Grade 2 or 3) to no pain (Grade 0).|2 hours post-dose|The Full Analysis Set (FAS) comprised participants who were treated and had a baseline assessment and at least one post-dose assessment up to or including the 2-hour time point. Missing data were imputed by using a Last Observation Carried Forward (LOCF) approach; baseline values were not carried forward to impute the missing post-treatment data.||Percentage of Participants|||Number
775679|NCT00759031|Primary|Gingival Margin Plaque Index|Scale 0 to 100% of tooth gingival margin covered by plaque. (0=no plaque, 100%=100% of the tooth's gingival margin is covered in plaque). The lower the score less dental plaque is present along the gum line and therefore the better the performance of the study treatment.|1 day|||Units on a scale||Standard Deviation|Mean
775680|NCT00759096|Secondary|Contrast Sensitivity||6 months after sugery of the 2nd eye||||||
775681|NCT00759096|Primary|Near Uncorrected Visual Acuity(UCVA|Near uncorrected visual acuity(UCVA) measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution and is used to measure visual acuity.|6 months after surgery of 2nd eye|||logMAR||Standard Deviation|Mean
775688|NCT00759148|Secondary|Eradication of Baseline Bacteria (Microbiological Success)|Microbiological success|Day 4 (12-48 hours after Day 3 final dose)|Microbiological intent-to-treat population (patients that were bacterial positive at Day 1)||Participants|||Number
775689|NCT00759148|Primary|Clinical Cure of Bacterial Conjunctivitis|Absence of bulbar conjunctival injection and conjunctival discharge/exudate (clinical cure)|Day 4 (12-48 hours after Day 3 final dose)|Microbiological intent-to-treat population (patients that were bacterial positive at Day 1)||Participants|||Number
775690|NCT00759161|Secondary|Percentage of Participants With Greater Decrease in Overall Target Plaque Severity Score (OTPSS) at Day 7,14, 21 and 35|OTPSS is a scale to assess plaque severity. Each target plaque was scored on a severity rating scale ranging from 0 (no plaque) to 8 (very severe plaque), where higher score indicated more severity of a plaque. In this outcome measure, percentage of participants with reduced OTPSS at Day 7, 14, 21 and 35 were reported and comparison of ointment and vehicle treated plaque was given as ‘Ointment treated plaque vs. vehicle treated plaque’ and ‘Vehicle treated plaque vs. ointment treated plaque’.|Day 7,14, 21, 35|ITT population included all randomized participants who received at least 1 dose of study drug.||percentage of participants|||Number
775691|NCT00759161|Secondary|Change From Baseline in Plaque Elevation at Day 7,14, 21, 28 and 35|Plaque elevation is a scale to assess plaque severity. Investigator rated presence of plaque elevation on a severity scale ranging, from 0 (no plaque elevation) to 8 (very marked plaque elevation), where higher score indicated more severe condition.|Baseline (Day 1), Day 7,14, 21, 28, 35|ITT population included all randomized participants who received at least 1 dose of study drug.||units on a scale||Standard Deviation|Mean
791681|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Potassium).||Baseline up to Month 7|||percentage of participants|||Number
775692|NCT00759161|Secondary|Change From Baseline in Scaling at Day 7,14, 21, 28 and 35|Scaling is a scale to assess plaque severity. Investigator rated the clinical appearance of scaling on a severity scale, ranging from 0 (no scaling on plaque) to 8 (very thick scales on plaque), where higher score indicated more severe condition.|Baseline (Day 1), Day 7,14, 21, 28, 35|ITT population included all randomized participants who received at least 1 dose of study drug.||units on a scale||Standard Deviation|Mean
775693|NCT00759161|Secondary|Change From Baseline in Erythema at Day 7,14, 21, 28 and 35|Erythema is used to assess plaque severity. Investigator rated the clinical appearance of erythema on a severity scale, ranging from 0 (no color on plaque, no erythema) to 8 (extreme red color on plaque, severe erythema), where higher score indicated more severe condition.|Baseline (Day 1), Day 7,14, 21, 28, 35|ITT population included all randomized participants who received at least 1 dose of study drug.||units on a scale||Standard Deviation|Mean
775694|NCT00759161|Secondary|Change From Baseline in Overall Target Plaque Severity Score (OTPSS) at Day 7,14, 21, 28 and 35|OTPSS is a scale to assess plaque severity. Each target plaque was scored on a severity scale ranging from 0 (no plaque) to 8 (very severe plaque), where higher score indicated more severity of a plaque.|Baseline (Day 1), Day 7,14, 21, 28, 35|ITT population included all randomized participants who received at least 1 dose of study drug.||units on a scale||Standard Deviation|Mean
775695|NCT00759161|Primary|Percentage of Participants With Greater Decrease in Overall Target Plaque Severity Score (OTPSS) at Day 28|OTPSS is a scale to assess plaque severity. Each target plaque was scored on a severity rating scale ranging from 0 (no plaque) to 8 (very severe plaque), where higher score indicated more severity of a plaque. In this outcome measure, percentage of participants with reduced OTPSS at Day 28 were reported and comparison of ointment and vehicle treated plaque was given as ‘Ointment treated plaque versus (vs.) vehicle treated plaque’ and ‘Vehicle treated plaque vs. ointment treated plaque’.|Day 28|ITT population included all randomized participants who received at least 1 dose of study drug.||percentage of participants|||Number
775696|NCT00759174|Other Pre-specified|Number of Weeks Exposed to PDE5i During 1-Week Case Window and 7 1-Week Control Windows Among Participants Adjudicated as Definite NAION Cases|Adjudication Committee classified participants as Definite, Possible, or Non-NAION cases, or insufficient information available or unable to adjudicate. Case window: 1 week preceding symptom onset day; 7 control windows: 7 weeks preceding case window. 1-week case or control window was considered exposed if any of 7 days were classified as exposed (sildenafil/vardenafil used on given day and/or previous day, or tadalafil used on given day and/or previous 4 days). In this analysis, each participant contributed exposure information for 1 case window and 7 control windows.|60-day period prior to onset of NAION symptoms|FAS population. N (number of participants analyzed) represents Definite NAION cases with PDE5i exposure on at least 1 day but not all 30 days or every week within 60 days prior to symptom onset.||exposed weeks|Participants||Number
775697|NCT00759174|Other Pre-specified|Number of Days Exposed to PDE5i During 1-Day Case Window and 29 1-Day Control Windows Among Participants Adjudicated as Definite or Possible NAION Cases|Adjudication committee classified participants as Definite, Possible, or Non-NAION cases, or insufficient information available or unable to adjudicate. Case window: 1 day preceding symptom onset day; 29 control windows: 29 days preceding case window. A case or control window was considered exposed if: sildenafil/vardenafil was used on that day and/or previous day; tadalafil was used on that day and/or any of previous 4 days. In this analysis, each participant contributed exposure information for 1 case window and 29 control windows.|30-day period prior to onset of NAION symptoms|FAS included all participants who signed informed consent, were eligible for study and reported exposure to PDEi within 60 days prior to participant reported-onset of NAION symptoms. N (number of participants analyzed) represents Definite or Possible NAION cases with PDE5i exposure on at least 1 day but not all 30 days prior to symptom onset.||exposed days|Participants||Number
775698|NCT00759174|Primary|Number of Days Exposed to PDE5i During 1-Day Case Window and 29 1-Day Control Windows Among Participants Adjudicated as Definite NAION Cases|Adjudication committee classified participants as Definite, Possible, or Non-NAION cases, or insufficient information available or unable to adjudicate. Case window: 1 day preceding symptom onset day; 29 control windows: 29 days preceding case window. A case or control window was considered exposed if: sildenafil/vardenafil was used on that day and/or previous day; tadalafil was used on that day and/or any of previous 4 days. In this analysis, each participant contributed exposure information for 1 case window and 29 control windows.|30-day period prior to onset of NAION symptoms|Full Analysis Set (FAS) included all participants who signed informed consent, were eligible for study, reported exposure to PDE5i within 60 days prior to participant-reported onset of NAION symptoms. N (number of participants analyzed) represents Definite NAION cases with PDE5i exposure on at least 1 day but not all 30 days prior to symptom onset.||exposed days|Participants||Number
775699|NCT00759187|Primary|Dental Plaque Index|Scale 0 to 5 (zero= no plaque to 5 = plaque covering 2/3 or more of the crown of the tooth)|4-Day|||Units on a scale||Standard Deviation|Mean
775700|NCT00759330|Secondary|Patient Assessment of Wearability of Therapy|"At Day 7, patients assessed the wearability of their treatment tape (ease of application, stays in place, comfortable to wear) using a 4-point scale, where:
1 = Excellent, 4 = Poor."|Day 7|Reported data are based on Intent-to-Treat patient population. Discrepancy in the number of participants analyzed for this outcome measure is due to discontinuations: 1 participant in the placebo tape12 hour group and 2 participants in the flurbiprofen tape groups (1 in the 12 hour group and 1 in the 24 hour group).||participants|||Number
775701|NCT00759330|Secondary|Percentage of Patients Who Discontinued|The percentage of patients who discontinued the study during the tape treatment phase due to lack of efficacy.|Days 1 through Day 7 of tape treatment phase|Reported data are based on Intent-to-Treat patient population.||percentage of patients who discontinued|||Number
775702|NCT00759330|Secondary|Acetaminophen Used During the Tape Treatment Phase|The total amount (mg) of rescue medication used during the tape treatment phase.|Day 1 through Day 7 of the tape treatment phase|Reported data are based on Intent-to-Treat patient population.||mg||Standard Error|Least Squares Mean
775703|NCT00759330|Secondary|Acetaminophen Used During the Tape Treatment Phase|The percentage of patients who used rescue medication during the tape treatment phase.|Day 1 through Day 7 of the tape treatment phase|Reported data are based on Intent-to-Treat patient population.||percentage of patients|||Number
776656|NCT00768066|Secondary|Incidence of the Major Adverse Cardiac Events (MACE) Endpoint, Defined as the Composite Incidence of (1) Death, (2) Hospitalization for Heart Failure, or (3) Non-fatal Recurrent MI.||12 months post-catheterization|||participants|||Number
775704|NCT00759330|Secondary|Patient Global Impression of Change (PGIC)|"At Day 7, patients provided their PGIC with regard to lower back pain response to treatment, using a 7-point scale, where:
1 = very much improved, 7 = very much worse."|Day 7|Reported data are based on Intent-to-Treat patient population. Discrepancy in the number of participants analyzed for this outcome measure is due to discontinuations: 1 participant in the placebo tape12 hour group and 2 participants in the flurbiprofen tape groups (1 in the 12 hour group and 1 in the 24 hour group).||participants|||Number
775705|NCT00759330|Secondary|Change From Baseline in Total Tender Point Examination Score|"At baseline and Day 7 of the tape treatment phase, patients had an assessment of tenderness bilaterally at the sacroiliac joint, greater trochanter of the hip, gluteus medius and minimus, and paraspinal muscles at L3-L4, L4-L5, and L5-S1. The investigator or research nurse pressed 12 specific areas of the body (6 locations, left and right sides), and patients were asked to rate the intensity of their pain at those 12 areas using an 11-point scale, where:
0 = no pain, 10 = the worst pain the patient has ever experienced. The total tender point examination score ranged from 0 (best outcome) to 120 (worst outcome). Change from baseline = baseline - Day 7. A positive change indicates a favorable treatment effect."|Baseline to Day 7 of tape treatment phase|Reported data are based on Intent-to-Treat patient population. Discrepancy in the number of participants analyzed for this outcome measure is due to discontinuations: 1 participant in the placebo tape12 hour group and 2 participants in the flurbiprofen tape groups (1 in the 12 hour group and 1 in the 24 hour group).||units on a scale||Standard Error|Least Squares Mean
775706|NCT00759330|Secondary|Percent Change From Baseline in Total Functional Rating Index (FRI)|"Patients completed the FRI, a 10-item back pain-specific measure of function questionnaire describing the condition at the time the questionnaire was completed; each item (pain intensity, sleeping, personal care, travel, etc.) was rated on a 5-point scale, where 0 = best outcome, 4 = worst outcome.
FRI was reported as the percent change from baseline at Day 7 of the tape treatment phase, where:
Total FRI score = sum of the 10 questions. The total FRI score ranged from 0 (best outcome) to 40 (worst outcome). Percent change = ([baseline - Day 7]/baseline)*100.
A positive percent change indicates a favorable treatment effect."|baseline to Day 7 of tape treatment phase|Reported data are based on Intent-to-Treat patient population. Discrepancy in the number of participants analyzed for this outcome measure is due to discontinuations: 1 participant in the placebo tape12 hour group and 2 participants in the flurbiprofen tape groups (1 in the 12 hour group and 1 in the 24 hour group).||percent change from baseline||Standard Error|Least Squares Mean
775707|NCT00759330|Secondary|Average Daily Categorical Pain Scale Scores|"Patients rated their lower back pain, caused by normal activity and movement, on an 11-point categorical pain scale, where:
0 = no pain, and 10 = worst pain imaginable. Patients rated their lower back pain every 12 hours, at any time they took medication including rescue medication for any type of pain, and if they applied or removed their treatment tapes at a time other than the scheduled time.
Data are reported as the daily average categorical pain scale score by treatment group."|Days 1 through 7 of tape treatment phase|Reported data are based on Intent-to-Treat patient population.||units on a scale||Standard Deviation|Mean
775708|NCT00759330|Secondary|Pain Intensity Difference (PID+)|"+PID = pre-treatment value at baseline – post-treatment value at day of evaluation, where: pre-treatment value at baseline = average daily pain over the last 3 days of the baseline phase (ie, average of daily averages of the categorical pain scale scores for the last 3 days of the baseline phase). Pain was rated on an 11-point scale, where: 0 = no pain, 10 = worst pain imaginable.
A positive PID indicates a reduction in pain."|Days 1 through 7 of tape treatment phase|Reported data are based on Intent-to-Treat patient population.||units on a scale||Standard Error|Least Squares Mean
775709|NCT00759330|Primary|Cumulative Summed Pain Intensity Difference (SPID+)|"The primary efficacy endpoint was the cumulative summed pain intensity difference (SPID+) at Days 4 and 7 of the tape treatment phase as computed from the daily categorical pain scale score reported on the patient's daily diary during the tape treatment phase; pain was rated on an 11-point scale, where: 0 = no pain, 10 = worst pain imaginable.
Summed pain intensity difference is the sum of the pain intensity differences (PID). PID at each post-baseline evaluation was computed as the average baseline categorical pain scale score minus the post-baseline categorical pain scale score from the daily dairy. For patients with multiple pain scores reported on a given post-baseline study day, the PID scores were averaged to compute one daily PID score for each patient."|Days 4 and 7 of tape treatment phase|Reported data are based on Intent-to-Treat patient population.||units on a scale||Standard Error|Least Squares Mean
775710|NCT00759356|Secondary|Area Under the Curve to Infinity for Plasma Morphine||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose|||hr*ng/mL||Standard Deviation|Mean
775711|NCT00759356|Secondary|Area Under the Curve to the Last Measurable Time Point for Plasma Morphine||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose|||hr*ng/mL||Standard Deviation|Mean
775712|NCT00759356|Secondary|Time of Maximum Plasma Morphine Concentration||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose|||hr||Full Range|Median
775713|NCT00759356|Primary|Mean Maximum Plasma Morphine Concentration||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose|||ng/mL||Standard Deviation|Mean
775714|NCT00759395|Secondary|The Number of Participants With at Least 50% Reduction of Hamilton Rating Scale for Anxiety (HAM-A)Total Score.|"Hamilton Rating Scale for Anxiety (HAM-A) response is defined as a >= 50% reduction from randomization (baseline) in HAM-A total score.
The Hamilton Rating Scale for Anxiety (HAM-A) is used as a rating measure of anxiety severity. The scale consists of 14 items. Each item is rated on a scale of 0 to 4. The HAM-A total score is the sum of the 14 items and the score ranges from 0 to 56, 0 is considered the best outcome."|Randomization to week 4|||Participants|||Number
775715|NCT00759395|Secondary|The Number of Participants With at Least 50% Reduction of Hamilton Rating Scale for Depression (HAM-D)Total Score.|"Hamilton Rating Scale for Depression (HAM-D) response is defined as a >= 50% reduction from randomization (baseline) in HAM-D total score.
Hamilton Rating Scale for Depression (HAM-D)is a 17-item, clinician-rated scale that assesses depressive symptoms. The HAMD-17 consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The HAMD-17 total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher HAMD-17 scores indicate more severe depression."|Randomization to week 4|||Participants|||Number
776657|NCT00768066|Secondary|Serial Creatine Kinase Values (Every 12 Hours for the First 48 Hours Post-catheterization).||Measured every 12 hours for the first 48 hours post-catheterization|||ng/mL||95% Confidence Interval|Mean
775716|NCT00759395|Secondary|Psychic Anxiety Item of the Hamilton Rating Scale for Depression (HAM-D).|"Psychic anxiety item of the Hamilton Rating Scale for Depression (HAM-D) (item 10, 0-4 units), 0 is considered the best outcome.
Hamilton Rating Scale for Depression (HAM-D)is a 17-item, clinician-rated scale that assesses depressive symptoms. The HAMD-17 consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The HAMD-17 total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher HAMD-17 scores indicate more severe depression."|Week 4|||Units on a scale||Standard Error|Least Squares Mean
775717|NCT00759395|Primary|Hamilton Rating Scale for Anxiety (HAM-A) Total Score.|The Hamilton Rating Scale for Anxiety (HAM-A) is used as a rating measure of anxiety severity. The scale consists of 14 items. Each item is rated on a scale of 0 to 4. The HAM-A total score is the sum of the 14 items and the score ranges from 0 to 56, 0 is considered the best outcome.|Week 4|||Units on a scale||Standard Error|Least Squares Mean
775718|NCT00759395|Primary|Hamilton Rating Scale for Depression (HAM-D) Total Score.|Hamilton Rating Scale for Depression (HAM-D)is a 17-item, clinician-rated scale that assesses depressive symptoms. The HAMD-17 consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The HAMD-17 total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher HAMD-17 scores indicate more severe depression.|Week 4|||Units on a scale||Standard Error|Least Squares Mean
775719|NCT00759473|Primary|Subjective Craving of Cocaine|Average of participants' subjective measures of craving immediately following cue exposure at the one-week follow-up session. Participants rated craving on a 10 point analog scale ranging from 0 (not at all) to 10 (extremely).|two weeks|Data of participants who completed all cue exposure sessions and the one-week follow-up were analyzed.||units on a scale||Standard Deviation|Mean
775720|NCT00759525|Primary|Forearm Blood Flow|At the end of each 14-day intervention (Glycyrrhinitic acid or Placebo), vascular endothelial function was assessed by measuring forearm blood flow and comparing to Baseline. The outcome measure depicted below reflects the change in forearm blood flow from Baseline after completing the glycyrrhinitic acid regimen as well as the change in forearm blood flow from Baseline after taking the matching placebo.|Outcome was measured at the end of each study period (i.e. 14 days after Baseline measurements were taken)|||ml/100ml of tissue/min||Standard Error|Mean
775721|NCT00759564|Secondary|Number of Participants With Change From Baseline in Physical Examinations|Physical examination included examination of the skin, eyes, ears, throat, neck, and cardiac, respiratory, gastrointestinal and musculoskeletal systems. The examination assessed the participants for any potential changes in physical status, as determined by the investigator. Any untoward findings identified on physical exams conducted after the administration of the first dose of study medication was captured as an adverse event.|Baseline, 7-10 days after the last dose of study drug|Safety analysis set included all participants who received the study medication.||participants|||Number
775722|NCT00759564|Secondary|Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities|Criteria for abnormal ECG (12-lead) values were defined as: maximum PR interval >=300 millisecond (msec) and maximum increase of >=25 percent for baseline value of >200 msec and >=50% for baseline value of <=200 msec for PR interval, QRS interval >=200 msec; QT interval corrected using the Fridericia formula (QTcF) >=500 msec or increase of >45 msec.|Baseline up to 7-10 days after the last dose of study drug (up to 32 days)|Safety analysis set included all participants who received the study medication.||participants|||Number
775723|NCT00759564|Secondary|Number of Participants With Vital Sign Abnormalities|Criteria for vital signs abnormalities included supine/sitting pulse rate of <40 beats per minute (bpm) or >120 bpm, supine systolic blood pressure (SBP) of <90 millimeter of mercury (mmHg), >=30 mmHg maximum increase and decrease from baseline in same posture, supine diastolic blood pressure (DBP) of <50 mmHg, >=20 mmHg maximum increase and decrease from baseline in same posture, heart rate <=45 beats per minute (bpm) or >=120 bpm or decrease/increase of >=15 bpm.|Baseline up to 7-10 days after the last dose of study drug (up to 32 days)|Safety analysis set included all participants who received the study medication.||participants|||Number
775724|NCT00759564|Secondary|Number of Participants With Laboratory Abnormalities|Criteria for laboratory test abnormality: Hematology (hemoglobin, hematocrit, red blood corpuscles [RBC] count: less than [<]0.8*lower limit of normal [LLN], platelets: <0.5*LLN/greater than [>]1.75*upper limit of normal [ULN], leukocytes: <0.6*LLN or >1.5*ULN, lymphocytes, total neutrophils: <0.8*LLN or >1.2*ULN, basophils, eosinophil, monocytes: >1.2*ULN); Liver Function (aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: >0.3*ULN, total protein, albumin: <0.8*LLN or >1.2*ULN); total bilirubin, direct bilirubin, indirect bilirubin: >1.5*ULN; Renal Function (blood urea nitrogen, creatinine: >1.3*ULN, uric acid: >1.2*ULN); Electrolytes (sodium: <0.95*LLN or >1.05*ULN, potassium, chloride, calcium, bicarbonate: <0.9*LLN or >1.1*ULN; creatine kinase: >2.0*ULN; glucose fasting: <0.6*LLN or >1.5*ULN, urine white blood corpuscles [WBC] and RBC: greater than or equal to (>=) 6/High Power Field [HPF]).|Baseline up to 7-10 days after the last dose of study drug (up to 32 days)|Safety analysis set included all participants who received the study medication.||participants|||Number
775725|NCT00759564|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 7-10 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.|Baseline up to 7-10 days after the last dose of study drug (up to 32 days)|Safety analysis set included all participants who received the study medication.||participants|||Number
775726|NCT00759564|Secondary|Concentration Versus Time Summary of Plasma Formate|Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLQ =100 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) =0.|1, 3, 8 hours post-dose|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.||hours||Standard Deviation|Mean
775862|NCT00754065|Secondary|Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 4|Reference Period 4 is defined as Day 271 to Day 360 during study treatment.|From Day 271 to Day 360|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
775727|NCT00759564|Secondary|Concentration Versus Time Summary of 2-Ethylbutyric Acid|Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLQ =100 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) =0.|1, 3, 8 hours post-dose|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.||hours||Standard Deviation|Mean
775728|NCT00759564|Secondary|Pharmacokinetics of CP-70429 and PF-03709270 Metabolites|PF-03709270 is an oral prodrug of CP-70,429. Upon oral absorption, PF-03709270 is rapidly hydrolyzed, yielding the active drug CP-70,429 and metabolites.|0.5, 2, 4, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|Data was not collected for this outcome because the metabolite data for CP-70,429 and PF-03709270 were not analyzed as per change in planned analysis|||||
775729|NCT00759564|Secondary|Duration of Plasma Concentrations of CP-70429 Exceeding 1.0 Microgram Per Milliliter Following PF-03709270 Oral Dose|Duration was calculated by subtracting the time at which the plasma concentrations exceeded 0.5 mcg/mL at the ascending part of the concentration-time profile from the time at which the plasma concentrations fell below 0.5 mcg/mL at the descending part of the profile. If these times fell between 2 observed concentrations, a method of linear interpolation was used for best estimation.|0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.||hours||Full Range|Median
775730|NCT00759564|Secondary|Duration of Plasma Concentrations of CP-70429 Exceeding 1.0 Microgram Per Milliliter Following Intravenous Dose|Duration was calculated by subtracting the time at which the plasma concentrations exceeded 1.0 mcg/mL at the ascending part of the concentration-time profile from the time at which the plasma concentrations fell below 1.0 mcg/mL at the descending part of the profile. If these times fell between 2 observed concentrations, a method of linear interpolation was used for best estimation.|0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.||hours||Full Range|Median
775731|NCT00759564|Secondary|Duration of Plasma Concentrations of CP-70429 Exceeding 0.5 Microgram Per Milliliter Following PF-03709270 Oral Dose|Duration was calculated by subtracting the time at which the plasma concentrations exceeded 0.5 mcg/mL at the ascending part of the concentration-time profile from the time at which the plasma concentrations fell below 0.5 mcg/mL at the descending part of the profile. If these times fell between 2 observed concentrations, a method of linear interpolation was used for best estimation.|0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.||hours||Full Range|Median
775732|NCT00759564|Secondary|Duration of Plasma Concentrations of CP-70429 Exceeding 0.5 Microgram Per Milliliter Following Intravenous Dose|Duration was calculated by subtracting the time at which the plasma concentrations exceeded 0.5 microgram per milliliter (mcg/mL) at the ascending part of the concentration-time profile from the time at which the plasma concentrations fell below 0.5 mcg/mL at the descending part of the profile. If these times fell between 2 observed concentrations, a method of linear interpolation was used for best estimation.|0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.||hours||Full Range|Median
775733|NCT00759564|Secondary|Apparent Oral Clearance (CL/F)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. It was calculated by dividing the given oral dose by AUCinf. AUC inf is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).|0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.||L/hr||Standard Deviation|Geometric Mean
775734|NCT00759564|Secondary|Clearance (CL)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. It was calculated by dividing given intravenous dose by AUC inf. AUC inf is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).|0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.||L/hr||Standard Deviation|Geometric Mean
775735|NCT00759564|Secondary|Terminal Elimination Half Life (t1/2) of CP-70429 Following PF-03709270 Oral Dose|Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.||hours||Standard Deviation|Mean
775736|NCT00759564|Secondary|Terminal Elimination Half Life (t1/2) of CP-70429 Following CP-70,429 Intravenous Dose|Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.||hours||Standard Deviation|Mean
775737|NCT00759564|Primary|Renal Clearance (CLr) of CP-70429 Following PF-03709270 Oral Dose|Renal clearance was calculated as cumulative amount of drug recovered unchanged in urine during the dosing interval (Ae) divided by area under the plasma concentration time-curve from time zero to end of dosing interval (AUCtau).|0 (pre-dose), 0 to 6, 6 to 12, 12 to 24 hours post-dose|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.||L/hr||Standard Deviation|Geometric Mean
775738|NCT00759564|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-inf)] of CP-70429 Following PF-03709270 Oral Dose|AUC (0-inf) is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).|0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.||ng*hr/mL||Standard Deviation|Geometric Mean
775739|NCT00759564|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of CP-70429 Following PF-03709270 Oral Dose|Area under the plasma concentration time-curve from zero (pre-dose) to the time of last measured concentration (AUClast).|0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.||ng*hr/mL||Standard Deviation|Geometric Mean
775740|NCT00759564|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of CP-70429 Following PF-03709270 Oral Dose||0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.||hours||Full Range|Median
775741|NCT00759564|Primary|Maximum Observed Plasma Concentration (Cmax) of CP-70429 Following PF-03709270 Oral Dose|PF-03709270 is an oral prodrug of CP-70,429. Upon oral absorption, PF-03709270 is rapidly hydrolyzed, yielding the active drug CP-70,429. Cmax of CP-70429 following CP-70,429 intravenous dose was reported.|0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The pharmacokinetic (PK) parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.||ng/mL||Standard Deviation|Geometric Mean
775742|NCT00759564|Primary|Renal Clearance (CLr) of CP-70429 Following CP-70,429 Intravenous Dose|Renal clearance was calculated as cumulative amount of drug recovered unchanged in urine during the dosing interval (Ae) divided by area under the plasma concentration time-curve from time zero to end of dosing interval (AUCtau).|0 (pre-dose), 0 to 6, 6 to 12, 12 to 24 hours post-dose|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.||liter per hour (L/hr)||Standard Deviation|Geometric Mean
775743|NCT00759564|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-inf)] of CP-70,429 Following CP-70,429 Intravenous Dose|AUC (0-inf) is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).|0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.||ng*hr/mL||Standard Deviation|Geometric Mean
775744|NCT00759564|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of CP-70429 Following CP-70,429 Intravenous Dose|Area under the plasma concentration time-curve from zero (pre-dose) to the time of last measured concentration (AUClast).|0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.||nanogram*hour per milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
775745|NCT00759564|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of CP-70429 Following CP-70,429 Intravenous Dose||0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.||hours||Full Range|Median
775746|NCT00759564|Primary|Maximum Observed Plasma Concentration (Cmax) of CP-70429 Following CP-70,429 Intravenous Dose|PF-03709270 is an oral prodrug of CP-70,429. Upon oral absorption, PF-03709270 is rapidly hydrolyzed, yielding the active drug CP-70,429. Cmax of CP-70429 following CP-70,429 intravenous dose was reported.|0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The pharmacokinetic (PK) parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
775747|NCT00759577|Primary|Improvement in Patient Perception of Bladder Condition Score (PPBC)|Difference in Patient Perception of Bladder Condition (PPBC) score from start of medication to end of trial (12 weeks). This is a single item patient reported global question that assesses a patients subjective impression of the current urinary problems. The patients is asked to rate their perceived bladder condition on a 6 point scale ranging from 1 (no problem) at all to 6 (many severe problems). To assess change in PPBC the baseline value is subtracted from the end of study value. Thus changes in score typically range from -2 to 2. Negative values represent an improvement.|12 weeks|There was no questionnaire available for analysis. Secondary to poor enrollment the study was stopped and efforts to collect questionnaires at an earlier time point were not carried out.|||||
775828|NCT00754065|Secondary|Onset of Withdrawal Bleeding Episodes at Cycle 3|Onset was defined as the number of days between progestogen withdrawal and the first day of the withdrawal bleeding episode (ie, starting on or after Day 25 for EV/DNG and on or after Day 22 for EE/NGM).|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
775748|NCT00759603|Primary|Overall Participant Response Rate: Percentage of Participants With Complete + Partial Response According to Revised National Cancer Institute-sponsored Working Group Guidelines|Complete response: Absence lymphadenopathy, hepatomegaly or splenomegaly & constitutional symptoms; Normal complete blood count (CBC) exhibited by polymorphonuclear leukocytes>1500/µL, platelets>100,000/µL, hemoglobin>11.0 g/dL (untransfused); lymphocyte count <5,000/µL; Bone marrow aspirate & biopsy normocellular for age with <30% nucleated cells lymphocytes; Absence Lymphoid nodules. Fulfillment CR criteria after induction with exception of treatment related persistent cytopenia & bone marrow lymphoid nodules both considered partial response; Partial response: Requires 50% decrease in peripheral lymphocytes from pre-treatment, 50% reduction in lymphadenopathy, &/or 50% reduction in splenomegaly/hepatomegaly for 2+ months from therapy completion. Additionally one following from pre-treatment: Polymorphonuclear leukocytes 1,500/µL or 50% improvement; Platelets>100,000/µL or 50% improvement; Hemoglobin>11.0 g/dL (untransfused) or 50% improvement.|Responses assessed after 12 cycles, up to 48 weeks with interim assessments performed after 3, 6 and 12 cycles.|||Percentage of Participants|||Number
775749|NCT00759642|Primary|Progression Free Survival|Progression free survival (PFS) will be defined as the interval between the date of study initiation and the earliest date of disease progression, determined by tumor assessment.|12 months|||months||80% Confidence Interval|Median
775750|NCT00759655|Secondary|Mean Number of Breakthrough (Spontaneous/Non-traumatic) Bleeds|The number of breakthrough (spontaneous/non-traumatic) bleeds within 48 hours following a prophylaxis dose of Xyntha was summarized. The data from the electronic Infusion Log Diary plus the Test Article CRF was used to determine the number of infusions administered to treat a new bleed, counting only those infusions administered =<48 hours after an infusion marked as 'prophylaxis' (which had no associated bleed).|Baseline to 24 months or early withdrawal.|The study was terminated, analysis was not conducted.||Bleeds|Participants|Standard Deviation|Mean
775751|NCT00759655|Secondary|Response to First On-demand Xyntha Treatment for All New Bleeds as Assessed by the Caregiver|A 4-point response scale to be completed is as defined as follows: (Excellent: definite pain relief/improvement in signs of bleeding starting within 8 hrs after an infusion, with no additional infusion; Good: definite pain relief/improvement in signs of bleeding starting within 8 hrs or following the infusion; Moderate: probable/slight improvement starting after 8 hours following the infusion; No Response: no improvement at all between infusions).|Baseline to 24 months or early withdrawal|The study was terminated, analysis was not conducted.||Scores on scale|||Number
775752|NCT00759655|Secondary|Number of Xyntha Infusions Needed to Treat Each New Bleed|The data from the electronic Infusion Log Diary plus the Test Article case report form (CRF) was used to determine the number of infusions administered to treat a bleed. This was calculated by adding the initial ‘for a new bleed’ (on demand) infusion to any subsequent (on demand) infusions for the (same) ‘previously treated bleed’. An on-demand infusion for a ‘previously treated bleed’ was counted toward the bleed with the most recent start time prior to that infusion.|Baseline to 24 months or early withdrawal.|The study was terminated, analysis was not conducted.||Infusions|Participants||Number
775753|NCT00759655|Secondary|Mean Annualized Bleed Rate (ABR)|An annualized bleeding rate (ABR) for each participant was calculated as the number of bleeds requiring administration of FVIII replacement product (taken from the electronic Infusion Log Diary), divided by his total therapy duration (in days), and then multiplied by 365.25.|Baseline to 24 months or early withdrawal.|The study was terminated, analysis was not conducted.||Number of Bleeds|Participants|Standard Deviation|Mean
775754|NCT00759655|Primary|Percentage of Participants With Low Recovery LETE|The LETE could be considered lower than expected recovery of FVIII in the opinion of the investigator following infusion of Xyntha in the absence of confounding factors.|Baseline to 24 months or early withdrawal.|The study was terminated, analysis was not conducted.||Percentage of participants|||Number
775755|NCT00759655|Primary|Percentage of Participants With LETE in the Prophylaxis Setting|The LETE in the prophylaxis setting was the occurrence of a bleed. LETE in the prophylaxis setting occurred if there was a spontaneous bleed within 48 hours (=<48 hours) after a regularly scheduled prophylactic dose of Xyntha (which was not used to treat a bleed) in the absence of confounding factors.|Baseline to 24 months or early withdrawal.|The study was terminated, analysis was not conducted.||Percentage of participants|||Number
775756|NCT00759655|Primary|Percentage of Participants With Less Than Expected Therapeutic Effects (LETE) in the On-Demand Setting|"LETE in the on-demand setting was based on the response to the treatment of a bleeding episode. LETE in the on-demand setting occurred if the participant recorded 2 successive No Response ratings (indicated there was no improvement at all between infusions or during the 24 hour interval following an infusion, or condition worsened) after 2 successive Xyntha infusions, respectively. The infusions was to be administered within 24 hours (=<24 hours) of each other for the treatment of the same bleeding event in the absence of confounding factor."|Baseline to 24 months or early withdrawal.|The study was terminated, analysis was not conducted.||Percentage of Participants|||Number
775757|NCT00759655|Primary|Percentage of Participants With Factor VIII (FVIII) Inhibitor Development|Incidence of inhibitor development was defined as any result determined positive at a central laboratory (Bethesda inhibitor titer of >=0.6 BU/mL) using Nijmegen modification of the Bethesda assay.|Baseline to 24 months or early withdrawal.|Intent-to-treat (ITT) population: Participants who had received at least 1 dose of Xyntha.||Percentage of participants|||Number
775758|NCT00759668|Primary|Near Uncorrected Visual Acuity Right Eye (UCVA RE)|Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted monocularly (right eye only) and with no correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the “logarithm of the minimum angle of resolution”. A lower logMAR value indicates better VA.|6 months after second eye implantation|The # of subjects analyzed does not match the # of subjects in the participant flow as Near Visual Acuity (VA) was analyzed in the Intent To Treat population (N=16 for both groups). VA data were collected in different units (ie c, twentieth, decimal, Jaeger) & were converted to LogMAR after inclusion in the database leading to data approximations.||Percentage of Participants|||Number
775850|NCT00754065|Secondary|Mean Length of Spotting-only Episodes in Reference Period 4|Reference Period 4 is defined as Day 271 to Day 360 during study treatment.|From Day 271 to Day 360|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
775759|NCT00759668|Primary|Near Best Corrected Visual Acuity Right Eye (BCVA RE)|Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted monocularly (right eye only) and with best correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the “logarithm of the minimum angle of resolution”. A lower logMAR value indicates better VA.|6 months after second eye implantation|The # of subjects analyzed does not match the # of subjects in the participant flow as Near Visual Acuity (VA) was analyzed in the Intent To Treat population (N=16 for both groups). VA data were collected in different units (ie c, twentieth, decimal, Jaeger) & were converted to LogMAR after inclusion in the database leading to data approximations.||Percentage of Participants|||Number
775760|NCT00759668|Primary|Near Uncorrected Visual Acuity Left Eye (UCVA LE)|Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted monocularly (left eye only) and with no correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the “logarithm of the minimum angle of resolution”. A lower logMAR value indicates better VA.|6 months after second eye implantation|The # of subjects analyzed does not match the # of subjects in the participant flow as Near Visual Acuity (VA) was analyzed in the Intent To Treat population (N=16 for both groups). VA data were collected in different units (ie c, twentieth, decimal, Jaeger) & were converted to LogMAR after inclusion in the database leading to data approximations.||Percentage of Participants|||Number
775761|NCT00759668|Primary|Near Best Corrected Visual Acuity Left Eye (BCVA LE)|Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted monocularly (left eye only) and with best correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the “logarithm of the minimum angle of resolution”. A lower logMAR value indicates better VA.|6 months after second eye implantation|The # of subjects analyzed does not match the # of subjects in the participant flow as Near Visual Acuity (VA) was analyzed in the Intent To Treat population (N=16 for both groups). VA data were collected in different units (ie c, twentieth, decimal, Jaeger) & were converted to LogMAR after inclusion in the database leading to data approximations.||Percentage of Participants|||Number
775762|NCT00759668|Primary|Near Uncorrected Visual Acuity (UCVA) Binocular|Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted binocularly and with no correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the “logarithm of the minimum angle of resolution”. A lower logMAR value indicates better VA.|6 months after second eye implantation|The # of subjects analyzed does not match the # of subjects in the participant flow as Near Visual Acuity (VA) was analyzed in the Intent To Treat population (N=16 for both groups). VA data were collected in different units (ie c, twentieth, decimal, Jaeger) & were converted to LogMAR after inclusion in the database leading to data approximations.||Percentage of Participants|||Number
775763|NCT00759668|Primary|Near Best Corrected Visual Acuity (BCVA) - Binocular|Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted binocularly and with best correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the “logarithm of the minimum angle of resolution”. A lower logMAR value indicates better VA.|6 months after second eye implantation|The # of subjects analyzed does not match the # of subjects in the participant flow as Near Visual Acuity (VA) was analyzed in the Intent To Treat population (N=16 for both groups). VA data were collected in different units (ie c, twentieth, decimal, Jaeger) & were converted to LogMAR after inclusion in the database leading to data approximations.||Percentage of Participants|||Number
775764|NCT00759681|Primary|Cumulative Incidence of Significant Bleeding, Infection, Neurological Deficit or Inflammatory/Immune Allergic Response|The Primary Safety Endpoint Will be the Cumulative Incidence of Significant Bleeding, Infection, Neurological Deficit or Inflammatory/Immune Allergic Response Through 6 Weeks.|Treatment through 6 weeks|Based on ITT population for primary safety analysis.||participants|||Number
775765|NCT00759681|Primary|Immediate Sealing Evidenced by no Bleeding on Clamp Release.|The immediate sealing evidenced by no bleeding on clamp release was measured at time of surgery|Immediate at time of surgery|Treatment sites were the unit of measure based on ITT for effectiveness outcomes.||Treatment sites|Participants||Number
775766|NCT00759707|Primary|Change From Baseline in Saphenous Vein Bypass Graft Vasodilation|Flow-mediated, endothelium-dependent vasodilation was determined by comparing baseline vein graft diameter with vein graft diameter as measured after deflation of a 2.5-inch wide sphygmomanometric cuff that had been inflated to suprasystolic pressure for 5 minutes. The cuff was never placed directly over the graft. Vasodilation of the vein graft was determined by acquiring images at 1 minute after cuff deflation.|Single visit study|||vein bypass graft size increase (%)||Standard Error|Mean
775767|NCT00759759|Secondary|Area Under the Curve to Infinity for Plasma Morphine||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose|||hr*ng/mL||Standard Deviation|Mean
775768|NCT00759759|Secondary|Area Under the Curve to the Last Measurable Time Point for Plasma Morphine||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36, 48 hrs post dose|||hr*ng/mL||Standard Deviation|Mean
775769|NCT00759759|Secondary|Time of Maximum Plasma Morphine Concentration||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose|||hr||Full Range|Median
775770|NCT00759759|Primary|Maximum Plasma Morphine Concentration||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose|||ng/mL||Standard Deviation|Mean
775771|NCT00753948|Secondary|Methacholine Challenge||During study visits, methacholine challenge will be performed 120 minutes post intervention.||||||
775773|NCT00753948|Primary|Exhaled Levels of Nitric Oxide|Nitric Oxide was measured applying a real time technique for measurement of Nitric Oxide in Exhaled Breath Condensate. Elevated Nitric Oxide in exhalate is a measure of elevated production of NO in conditions such as underlying inflammation and/or oxidative stress|Exhaled NO was reported as the mean of three values within 10% of each other.|||ppb (parts per bilion)||Standard Deviation|Mean
775774|NCT00754013|Secondary|Mean Change From(Baseline) to Visit 3(Week 10 or Early Termination) in VABS-II/PCRF Sum of the 9 Sub-domain V-scores (3 Scores for Each of the Communication, Daily Living Skills, and Socialization Domains) Using Last Observation Carried Forward.|The planned secondary objectives of the study included further evaluation of efficacy as assessed by additional analyses of the VABS-II/PCRF, by analyses of the Test of Verbal Expression and Reasoning (TOVER), a subject-performance-based measure of expressive language function, and by the Forward Memory and Attention Sustained sub-tests of the Leiter International Performance Scale - Revised (Leiter-R), a cognitive assessment instrument for children and adolescents that is not language dependent. In addition, observed case analyses of these assessments at Week 4 and Week 10 were planned.|Visit 1 (Baseline) to Visit 3 (Week 10 or early termination).|This study was terminated early. Secondary efficacy data were not analyzed since only 9 of the 140 planned subjects had been enrolled.|||||
775775|NCT00754013|Primary|Vineland-II Adaptive Behavior Scales (VABS-II) Parent/Caregiver Rating Form (PCRF) Sum of the 9 Sub-domain V-scores (3 Scores for Each of the Communication, Daily Living Skills, and Socialization Domains) Using Last Observation Carried Forward.|The primary objective of the study was evaluation of the efficacy and safety of donepezil hydrochloride in the treatment of the cognitive dysfunction exhibited by children with Down syndrome (DS), aged 6 to 10, as assessed by analysis of VABS-II/PCRF in the domains of communication, daily living skills, and socialization, and as assessed by standard safety measurements.|Visit 0 (Screen), Visits 1 (Baseline), 2, and 3 (or Early Termination).|The planned efficacy analysis was on the intent-to-treat (ITT) population. This study was terminated early. Primary efficacy data were not analyzed since only 9 of the 140 planned subjects had been enrolled.|||||
775776|NCT00754065|Other Pre-specified|The Change of Pelvic Pain or Headache as Determined by the Highest Visual Analog Scale (VAS) Values During Cycle Days 22 to 28 From Baseline to Cycle 6|Subject self-assessed pelvic pain or headache per visual analog scale (VAS) values during the menstrual/withdrawal bleeding episode and Baseline. The VAS consists of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst).|Days 22-28 from Baseline to Days 22-28 from Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||mm||Standard Deviation|Mean
775777|NCT00754065|Other Pre-specified|Percentage of Participants With no Increase in Rescue Medication and VAS Decrease During Cycle Days 22 to 28 From Baseline to Cycle 6|Rescue medication was standardized intake of 200 mg Ibuprofen tablets. Baseline: 7 days (Day 22) before first menstrual bleeding to Day 28. Treatment: 7 days (Day 22) before withdrawal bleeding of 6th cycle to Day 28 before the same cycle. The visual analog scale (VAS) is a subject-assessed measure of pelvic pain or headache consisting of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst).|Day 22-28 from Baseline to Day 22-28 from Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Percentage of participants|||Number
775778|NCT00754065|Secondary|Percentage of Participants With Improvement in the Participant's Assessment in Clinical Global Impression (CGI) at Cycle 13|In 1 section of the CGI the subject rates their total improvement and rate of satisfaction with sexuality during treatment. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement.|At Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Percentage of participants|||Number
775779|NCT00754065|Secondary|Percentage of Participants With Improvement in the Participant's Assessment in Clinical Global Impression (CGI) at Cycle 6|In 1 section of the CGI the subject rates their total improvement and rate of satisfaction with sexuality during treatment. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Percentage of participants|||Number
775780|NCT00754065|Secondary|Percentage of Participants With Improvement in the Investigator's Assessment in Clinical Global Impression (CGI) at Cycle 13|CGI is used to collect information regarding the subject's total clinical experience. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement.|At Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Percentage of participants|||Number
775781|NCT00754065|Secondary|Percentage of Participants With Improvement in the Investigator's Assessment in Clinical Global Impression (CGI) at Cycle 6|CGI is used to collect information regarding the subject's total clinical experience. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Percentage of participants|||Number
775782|NCT00754065|Secondary|Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – Overall Life Satisfaction and Contentment|Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (overall life satisfaction and contentment). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
775851|NCT00754065|Secondary|Mean Length of Spotting-only Episodes in Reference Period 3|Reference Period 3 is defined as Day 181 to Day 270 during study treatment.|From Day 181 to Day 270|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
775783|NCT00754065|Secondary|Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – Overall Life Satisfaction and Contentment|Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (overall life satisfaction and contentment). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
775784|NCT00754065|Secondary|Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – Item Satisfaction|Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (item satisfaction). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
775785|NCT00754065|Secondary|Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – Item Satisfaction|Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (item satisfaction). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
775786|NCT00754065|Secondary|Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – General Activities|Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (general activities - 16 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
775787|NCT00754065|Secondary|Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – General Activities|Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (general activities - 16 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
775788|NCT00754065|Secondary|Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – Social Relationship|Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (social relationship - 11 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
775789|NCT00754065|Secondary|Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – Social Relationship|Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (social relationship - 11 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
775790|NCT00754065|Secondary|Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – Leisure Time Activities|Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (leisure time activities - 6 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
775791|NCT00754065|Secondary|Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – Leisure Time Activities|Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (leisure time activities - 6 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
775792|NCT00754065|Secondary|Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – School/Course Work|Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (school / course work – yes or no; if yes, then 4 choices, and 10 items with a scale of 1-5 (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
775793|NCT00754065|Secondary|Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – School/Course Work|Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (school / course work – yes or no; if yes, then 4 choices, and 10 items with a scale of 1-5 (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
775852|NCT00754065|Secondary|Mean Length of Spotting-only Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
775794|NCT00754065|Secondary|Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – Household Duties|Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (household duties – yes or no; if yes, then 4 choices, and 10 items with a scale of 1-5 [very poor, poor, fair, good, very good]). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
775795|NCT00754065|Secondary|Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – Household Duties|Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (household duties – yes or no; if yes, then 4 choices, and 10 items with a scale of 1-5 [very poor, poor, fair, good, very good]). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
775796|NCT00754065|Secondary|Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – Work|Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (work – yes or no; if yes, then 4 choices, and 13 items with a scale of 1-5 [very poor, poor, fair, good, very good]). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
775797|NCT00754065|Secondary|Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – Work|Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (work – yes or no; if yes, then 4 choices, and 13 items with a scale of 1-5 [very poor, poor, fair, good, very good]). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
775798|NCT00754065|Secondary|Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – Participant Feeling|Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (participant feeling - 14 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
775799|NCT00754065|Secondary|Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – Participant Feeling|Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (participant feeling - 14 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
775800|NCT00754065|Secondary|Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – Physical Health|Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (physical health - 13 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
775801|NCT00754065|Secondary|Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – Physical Health|Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (physical health - 13 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
775802|NCT00754065|Secondary|Mean Change From Baseline to Cycle 13 in Psychological General Well-Being Index (PGWBI)|Change from Baseline to Cycle 13 in PGWBI Questionnaire's assessment of participant's overall sense of well-being or distress. The PGWBI includes 22 items that, apart from combining into a global overall score, are divided into 6 dimensions: anxiety, depressed mood, positive well-being, self-control, health, and vitality. The response format used a 6-grade Likert scale and the change in the normalized PGWBI global score as well as all the sub-domains score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
775803|NCT00754065|Secondary|Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI)|Change from Baseline to Cycle 6 in PGWBI Questionnaire's assessment of participant's overall sense of well-being or distress. The PGWBI includes 22 items that, apart from combining into a global overall score, are divided into 6 dimensions: anxiety, depressed mood, positive well-being, self-control, health, and vitality. The response format used a 6-grade Likert scale and the change in the normalized PGWBI global score as well as all the sub-domains score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
775804|NCT00754065|Secondary|Percentage of Participants With at Least 1 Intracyclic Bleeding Episode at Cycles 2 to 13|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|Cycles 2 to 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Percentage of participants|||Number
775805|NCT00754065|Secondary|Percentage of Participants With at Least 1 Intracyclic Bleeding Episode at Cycles 2 to 6|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|Cycles 2 to 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Percentage of participants|||Number
775806|NCT00754065|Secondary|Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 13|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.|At Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Percentage of participants|||Number
775807|NCT00754065|Secondary|Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 6|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Percentage of participants|||Number
775808|NCT00754065|Secondary|Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Percentage of participants|||Number
775809|NCT00754065|Secondary|Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Percentage of participants|||Number
775810|NCT00754065|Secondary|Number of Intracyclic Bleeding Days at Cycle 13|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
775811|NCT00754065|Secondary|Number of Intracyclic Bleeding Days at Cycle 6|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
775812|NCT00754065|Secondary|Number of Intracyclic Bleeding Days at Cycle 3|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
775813|NCT00754065|Secondary|Number of Intracyclic Bleeding Days at Cycle 1|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
775814|NCT00754065|Secondary|Maximum Length of Intracyclic Bleeding Episodes at Cycle 13|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
775815|NCT00754065|Secondary|Maximum Length of Intracyclic Bleeding Episodes at Cycle 6|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
775816|NCT00754065|Secondary|Maximum Length of Intracyclic Bleeding Episodes at Cycle 3|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
775817|NCT00754065|Secondary|Maximum Length of Intracyclic Bleeding Episodes at Cycle 1|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
775818|NCT00754065|Secondary|Number of Intracyclic Bleeding Episodes at Cycle 13|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (Episode is a set of days with intracyclic bleeding)|At Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Episodes||Standard Deviation|Mean
775819|NCT00754065|Secondary|Number of Intracyclic Bleeding Episodes at Cycle 6|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (Episode is a set of days with intracyclic bleeding)|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Episodes||Standard Deviation|Mean
775820|NCT00754065|Secondary|Number of Intracyclic Bleeding Episodes at Cycle 3|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (Episode is a set of days with intracyclic bleeding)|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Episodes||Standard Deviation|Mean
775821|NCT00754065|Secondary|Number of Intracyclic Bleeding Episodes at Cycle 1|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (Episode is a set of days with intracyclic bleeding)|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Episodes||Standard Deviation|Mean
775822|NCT00754065|Secondary|Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 13|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Percentage of participants|||Number
775823|NCT00754065|Secondary|Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 6|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Percentage of participants|||Number
775824|NCT00754065|Secondary|Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 3|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Percentage of participants|||Number
775825|NCT00754065|Secondary|Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 1|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Percentage of participants|||Number
775826|NCT00754065|Secondary|Onset of Withdrawal Bleeding Episodes at Cycle 13|Onset was defined as the number of days between progestogen withdrawal and the first day of the withdrawal bleeding episode (ie, starting on or after Day 25 for EV/DNG and on or after Day 22 for EE/NGM).|At Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
775829|NCT00754065|Secondary|Onset of Withdrawal Bleeding Episodes at Cycle 1|Onset was defined as the number of days between progestogen withdrawal and the first day of the withdrawal bleeding episode (ie, starting on or after Day 25 for EV/DNG and on or after Day 22 for EE/NGM).|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
775830|NCT00754065|Secondary|Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 13|Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.|At Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
775831|NCT00754065|Secondary|Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6|Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
775832|NCT00754065|Secondary|Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3|Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
775833|NCT00754065|Secondary|Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1|Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
775834|NCT00754065|Secondary|Length of Withdrawal Bleeding Episodes at Cycle 13|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.|At Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
775835|NCT00754065|Secondary|Length of Withdrawal Bleeding Episodes at Cycle 6|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
775836|NCT00754065|Secondary|Length of Withdrawal Bleeding Episodes at Cycle 3|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
775837|NCT00754065|Secondary|Length of Withdrawal Bleeding Episodes at Cycle 1|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
775838|NCT00754065|Secondary|Percentage of Participants With / Without Withdrawal Bleeding at Cycle 13|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.|At Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Percentage of participants|||Number
775839|NCT00754065|Secondary|Percentage of Participants With / Without Withdrawal Bleeding at Cycle 6|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Percentage of participants|||Number
775840|NCT00754065|Secondary|Percentage of Participants With / Without Withdrawal Bleeding at Cycle 3|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Percentage of participants|||Number
775841|NCT00754065|Secondary|Percentage of Participants With / Without Withdrawal Bleeding at Cycle 1|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Percentage of participants|||Number
775842|NCT00754065|Secondary|Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 4|Reference Period 4 is defined as Day 271 to Day 360 during study treatment.|From Day 271 to Day 360|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
775843|NCT00754065|Secondary|Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 3|Reference Period 3 is defined as Day 181 to Day 270 during study treatment.|From Day 181 to Day 270|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
775844|NCT00754065|Secondary|Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
775845|NCT00754065|Secondary|Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
775846|NCT00754065|Secondary|Maximum Length of Spotting-only Episodes in Reference Period 4|Reference Period 4 is defined as Day 271 to Day 360 during study treatment.|From Day 271 to Day 360|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
775847|NCT00754065|Secondary|Maximum Length of Spotting-only Episodes in Reference Period 3|Reference Period 3 is defined as Day 181 to Day 270 during study treatment.|From Day 181 to Day 270|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
775848|NCT00754065|Secondary|Maximum Length of Spotting-only Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
775849|NCT00754065|Secondary|Maximum Length of Spotting-only Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
775863|NCT00754065|Secondary|Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 3|Reference Period 3 is defined as Day 181 to Day 270 during study treatment.|From Day 181 to Day 270|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
775864|NCT00754065|Secondary|Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
775865|NCT00754065|Secondary|Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
775866|NCT00754065|Secondary|Maximum Length of Bleeding / Spotting Episodes in Reference Period 4|Reference Period 4 is defined as Day 271 to Day 360 during study treatment.|From Day 271 to Day 360|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
775867|NCT00754065|Secondary|Maximum Length of Bleeding / Spotting Episodes in Reference Period 3|Reference Period 3 is defined as Day 181 to Day 270 during study treatment.|From Day 181 to Day 270|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
775868|NCT00754065|Secondary|Maximum Length of Bleeding / Spotting Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
775869|NCT00754065|Secondary|Maximum Length of Bleeding / Spotting Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
775870|NCT00754065|Secondary|Mean Length of Bleeding / Spotting Episodes in Reference Period 4|Reference Period 4 is defined as Day 271 to Day 360 during study treatment.|From Day 271 to Day 360|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
775871|NCT00754065|Secondary|Mean Length of Bleeding / Spotting Episodes in Reference Period 3|Reference Period 3 is defined as Day 181 to Day 270 during study treatment.|From Day 181 to Day 270|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
775872|NCT00754065|Secondary|Mean Length of Bleeding / Spotting Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
775873|NCT00754065|Secondary|Mean Length of Bleeding / Spotting Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
775874|NCT00754065|Secondary|Number of Bleeding / Spotting Episodes in Reference Period 4|Reference Period 4 is defined as Day 271 to Day 360 during study treatment. (Episode is a set of days with bleeding/spotting)|From Day 271 to Day 360|All participants in FAS with assessment for this outcome measure||Episodes||Standard Deviation|Mean
775875|NCT00754065|Secondary|Number of Bleeding / Spotting Episodes in Reference Period 3|Reference Period 3 is defined as Day 181 to Day 270 during study treatment. (Episode is a set of days with bleeding/spotting)|From Day 181 to Day 270|All participants in FAS with assessment for this outcome measure||Episodes||Standard Deviation|Mean
775876|NCT00754065|Secondary|Number of Bleeding / Spotting Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment. (Episode is a set of days with bleeding/spotting)|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure||Episodes||Standard Deviation|Mean
775877|NCT00754065|Secondary|Number of Bleeding / Spotting Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes. (Episode is a set of days with bleeding/spotting)|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure||Episodes||Standard Deviation|Mean
775878|NCT00754065|Secondary|Number of Days With Bleeding or Spotting in Reference Period 4|Reference Period 4 is defined as Day 271 to Day 360 during study treatment.|From Day 271 to Day 360|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
775879|NCT00754065|Secondary|Number of Days With Bleeding or Spotting in Reference Period 3|Reference Period 3 is defined as Day 181 to Day 270 during study treatment.|From Day 181 to Day 270|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
775880|NCT00754065|Secondary|Number of Days With Bleeding or Spotting in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
775881|NCT00754065|Secondary|Number of Days With Bleeding or Spotting in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
775882|NCT00754065|Secondary|Change From Baseline to Cycle 13 in the Average of the Three Highest VAS Values of the Hormone Withdrawal-associated Symptoms Pelvic Pain or Headache During Cycle Days 22 to 28|Subject self-assessed pelvic pain or headache per visual analog scale (VAS) values during the menstrual/withdrawal bleeding episode and Baseline. The VAS consists of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst).|Days 22-28 from Baseline to Days 22-28 from Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||mm||Standard Deviation|Mean
775883|NCT00754065|Secondary|Change From Baseline to Cycle 3 in the Average of the Three Highest VAS Values of the Hormone Withdrawal-associated Symptoms Pelvic Pain or Headache During Cycle Days 22 to 28|Subject self-assessed pelvic pain or headache per visual analog scale (VAS) values during the menstrual/withdrawal bleeding episode and Baseline. The VAS consists of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst).|Days 22-28 from Baseline to Days 22-28 from Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||mm||Standard Deviation|Mean
775884|NCT00754065|Secondary|Change From Baseline to Cycle 13 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During the Hormone-free Interval Cycle Days 27 to 28 for EV/DNG and Cycle Days 22 to 28 for EE/NGM|Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode (cycle Days 22-28). Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Score difference min -2 (best), max 2 (worst) for the EV/DNG group and min -7 (best), max 7 (worst) for the EE/NGM group.|From Baseline to Cycle 13 (cycle Days 27 to 28 for EV/DNG and cycle Days 22 to 28 for EE/NGM, 28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
775885|NCT00754065|Secondary|Change From Baseline to Cycle 6 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During the Hormone-free Interval Cycle Days 27 to 28 for EV/DNG and Cycle Days 22 to 28 for EE/NGM|Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode (cycle Days 22-28). Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Score difference min -2 (best), max 2 (worst) for the estradiol valerate (EV)/dienogest (DNG) group and min -7 (best), max 7 (worst) for the ethinylestradiol (EE)/norgestimate (NGM) group.|From Baseline to Cycle 6 (cycle Days 27 to 28 for EV/DNG and cycle Days 22 to 28 for EE/NGM, 28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
775886|NCT00754065|Secondary|Change From Baseline to Cycle 13 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During Cycle Days 1-21|Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode during cycle Days 1-21. Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Baseline period: cycle Days 1-21 before 1st menstrual bleeding (normalized to a 21-day period). Treatment period: cycle Days 1-21 before WB of 13th treatment cycle (normalized to a 21-day period). Score difference min -21 (best), max 21 (worst).|Day 1-21 from Baseline to Day 1-21 from Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
775887|NCT00754065|Secondary|Change From Baseline to Cycle 6 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During Cycle Days 1-21|Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode during cycle Days 1-21. Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Baseline period: cycle Days 1-21 before 1st menstrual bleeding (normalized to a 21-day period). Treatment period: cycle Days 1-21 before WB of 6th treatment cycle (normalized to a 21-day period). Score difference min -21 (best), max 21 (worst).|Day 1-21 from Baseline to Day 1-21 from Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
775888|NCT00754065|Secondary|Change From Baseline to Cycle 13 in the Number of Days With at Least Moderate Pain/Intensity of Other Hormone-related Symptoms During Cycle Days 22-28|Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode during cycle Days 22-28. Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Baseline period: cycle Days 22-28 before 1st menstrual bleeding (normalized to a 7-day period). Treatment period: cycle Days 22-28 before WB of 13th treatment cycle (normalized to a 7-day period). Score difference min -7 (best), max 7 (worst).|Day 22-28 from Baseline to Day 22-28 from Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
775889|NCT00754065|Secondary|Change From Baseline to Cycle 6 in the Number of Days With at Least Moderate Pain/Intensity of Other Hormone-related Symptoms During Cycle Days 22-28|Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode during cycle Days 22-28. Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Baseline period: cycle Days 22-28 before 1st menstrual bleeding (normalized to a 7-day period). Treatment period: cycle Days 22-28 before WB of 6th treatment cycle until (normalized to a 7-day period). Score difference min -7 (best), max 7 (worst).|Day 22-28 from Baseline to Day 22-28 from Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
775890|NCT00754065|Secondary|The Change From Baseline to Cycle 13 in the Number of Ibuprofen Tablets Used as Rescue Medication|Rescue medication use was standardized intake of 200 mg Ibuprofen tablets. Baseline period: 7 days (Day 22) before the first menstrual bleeding until Day 28 (normalized to a standard 28-day cycle). Treatment period: 7 days (Day 22) before the withdrawal bleeding (WB) of the 13th treatment cycle until Day 28 before the same cycle (normalized to a standard 28-day cycle). Number of tablets taken by each subject, and then the Mean and standard deviation ((SD) derived.|From Baseline to Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Tablets||Standard Deviation|Mean
775891|NCT00754065|Secondary|The Change From Baseline to Cycle 6 in the Number of Ibuprofen Tablets Used as Rescue Medication|Rescue medication use was standardized intake of 200 mg Ibuprofen tablets. Baseline period: 7 days (Day 22) before the first menstrual bleeding until Day 28 (normalized to a standard 28-day cycle). Treatment period: 7 days (Day 22) before the withdrawal bleeding (WB) of the 6th treatment cycle until Day 28 of the same cycle (normalized to a standard 28-day cycle). Number of tablets taken by each subject, and then the Mean and standard deviation (SD) derived.|From Baseline to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Tablets||Standard Deviation|Mean
775892|NCT00754065|Primary|The Change in Average of the 3 Highest Visual Analog Scale (VAS) Values of the Hormone Withdrawal-associated Symptoms Pelvic Pain or Headache During Cycle Days 22 to 28 From Baseline to Cycle 6|Subject self-assessed pelvic pain or headache per visual analog scale (VAS) values during the menstrual/withdrawal bleeding episode and Baseline. The VAS consists of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst).|Day 22-28 from Baseline to Day 22-28 from Cycle 6 (28 days per Cycle)|All participants in Full Analysis Set (FAS) with assessment for this outcome measure||mm||Standard Deviation|Mean
775893|NCT00754130|Secondary|Plasma Pharmacokinetic Parameter: Day 5 to Day 1 Accumulation Ratio for AUC (0-24hr), Cmax, and C24hr|Geometric Mean of the Day 5 to Day 1 Accumulation Ratio|Day 5 and Day 1|All participants with pharmacokinetic measurements on Days 1 and 5||Ratio||Full Range|Geometric Mean
775894|NCT00754130|Primary|Number of Participants Who Discontinued Study Drug Due to an AE|"An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.
Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2."|Up to 14 days after last dose of study drug|Safety Population, consisting of all randomized participants who received at least one dose of study drug.||participants|||Number
775895|NCT00754130|Secondary|Plasma Pharmacokinetic Parameter: Apparent Terminal Elimination Half-life (t1/2) of MK-0941|Blood samples for measurement of plasma pharmacokinetic parameters were collected from predose to up to 24 hours postdose on Day 1 and from predose to up to 72 hours postdose on Day 5 in each treatment period.|Up to 72 hours after study drug administration|Participants with a t1/2 measurement||hr||Standard Deviation|Mean
775896|NCT00754130|Secondary|Plasma Pharmacokinetic Parameter: Concentration of MK-0941 at 24 Hours (C24hr)|Blood samples for measurement of plasma pharmacokinetic parameters were collected from predose to up to 24 hours postdose on Day 1 and from predose to up to 72 hours postdose on Day 5 in each treatment period.|Up to 72 hours after study drug administration|Participants with a C24hr measurement||nmol/L||Standard Deviation|Mean
775897|NCT00754130|Secondary|Plasma Pharmacokinetic Parameter: Time to Reach Cmax (Tmax) of MK-0941|Blood samples for measurement of plasma pharmacokinetic parameters were collected from predose to up to 24 hours postdose on Day 1 and from predose to up to 72 hours postdose on Day 5 in each treatment period.|Up to 72 hours after study drug administration|Participants with a Tmax measurement||hr||Full Range|Median
775898|NCT00754130|Secondary|Plasma Pharmacokinetic Parameter: Maximum Concentration (Cmax) of MK-0941|Blood samples for measurement of plasma pharmacokinetic parameters were collected from predose to up to 24 hours postdose on Day 1 and from predose to up to 72 hours postdose on Day 5 in each treatment period.|Up to 72 hours after study drug administration|Participants with a Cmax measurement||nmol/L||Standard Deviation|Mean
775899|NCT00754130|Secondary|Plasma Pharmacokinetic Parameter: Area Under the Concentration-time Curve (AUC)(0-24hr) of MK-0941|Blood samples for measurement of plasma pharmacokinetic parameters were collected from predose to up to 24 hours postdose on Day 1 and from predose to up to 72 hours postdose on Day 5 in each treatment period.|Up to 72 hours after study drug administration|Participants with an AUC(0-24hr) measurement||nmol*hr/L||Standard Deviation|Mean
775900|NCT00754130|Primary|Number of Participants Who Experienced at Least One Adverse Event (AE)|"An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.
Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2."|Up to 14 days after last dose of study drug|Safety Population, consisting of all randomized participants who received at least one dose of study drug.||participants|||Number
775901|NCT00754156|Secondary|Blood Transfused||Duration of Hospital Stay less than 6 months|||Units||Inter-Quartile Range|Median
775902|NCT00754156|Secondary|Hospital Days||Duration of Hospital Stay less than 6 months|||Days||Inter-Quartile Range|Median
775903|NCT00754156|Secondary|ICU Days||Duration of hospital stay less than 6 months|||Days||Inter-Quartile Range|Median
775904|NCT00754156|Secondary|Days to Closure||Duration of Hospital Stay less than 6 months|||Days||Inter-Quartile Range|Median
775905|NCT00754156|Primary|Operating Room Time Utilization|The amount of time needed to manage the open abdomen inside the operating room.|Duration of Hospital Stay less than 6 months|||Minutes||Standard Deviation|Mean
775906|NCT00754156|Primary|Number of Trips to the Operating Room||12 Months|||Number of trips||Inter-Quartile Range|Median
775907|NCT00754156|Primary|Primary Closure Rate|The rate in which the abdomen was closed the first time.|up to 12 months|Descriptive Study.||% of participants|||Number
775908|NCT00759772|Primary|Percent Change in Lumbar Spine Bone Mineral Density|Percent increase or decrease in lumbar spine bone mineral density between baseline and 6 months (treatment period)|Baseline and 6 months|All participants were included in analysis (intention to treat).||percentage of change||Standard Error|Mean
775909|NCT00759785|Secondary|Change From Baseline in IGF1R Membrane H-Score After a Single Dose of Dalotuzumab|IGF1R expression was measured in pre and post-dose biopsy samples using an immunohistochemistry assay. Results were expressed as an IGF1R membrane H-score. The H-score was calculated from the percentage of cells staining very weak (+/-); weak (1+); moderate (2+); or strong (3+) and obtained by the formula: (3 x percentage of strongly staining nuclei) + (2 x percentage of moderately staining nuclei) + (1 x percentage of weakly staining nuclei) + (0.5 x percentage of weakly staining nuclei). The H-score ranges from 0 to 300; with a score of 0 representing the absence of IGF1R expression and an H-score of 300 representing maximum IGF1R expression. A decrease in IGF1R membrane H-score was an indication of target engagement by dalotuzumab. A larger decrease in H-score correlated with a greater target engagement|Baseline and Up to 12 Days|All participants who received a single dose of dalotuzumab, had evaluable baseline and post-dose biopsy samples, and had H-score data available for pre- and post-dose measurements.||H-score||Full Range|Mean
776167|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 12)|Feeling of nausea is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 12.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
775910|NCT00759785|Secondary|Percentage of IGF1R Negative Participants With a Decrease in GFS by Cohort|Biopsy samples were considered IGF1R negative if less than 10% of tumor cells stain. GFS response was correlated with IGF1R expression for ER-positive luminal B and triple negative cohorts.|Up to 12 Days Post-dose|All participants who received a single dose of dalotuzumab, were IGF1R negative at baseline, and had evaluable postdose biopsy samples.||Percentage of participants||80% Confidence Interval|Number
775911|NCT00759785|Secondary|Percentage of IGF1R Positive Participants With a Decrease in GFS by Cohort|Insulin-like Growth Factor Receptor Type 1 (IGF1R) expression was measured in pre-dose biopsy samples using an immunohistochemistry assay to establish baseline IGF1R positivity. Biopsy samples were considered IGF1R positive if at least 10% of tumor cells stain with intensity 1+ or greater based on staining criteria of very weak (+/-); weak (1+); moderate (2+); or strong (3+). GFS response was correlated with IGF1R expression for ER-positive luminal B and triple negative cohorts.|Up to 12 Days Post-dose|All participants who received a single dose of dalotuzumab, were IGF1R positive at baseline, and had evaluable postdose biopsy samples.||Percentage of participants||80% Confidence Interval|Number
775912|NCT00759785|Primary|Percentage of Participants Demonstrating a Decrease in the Growth Factor Signature (GFS)|GFS was measured by microarray analysis of the entire 101 gene signature expression. The GFS is quantified as the change in gene expression between two separate samples collected from the same participant. A log (base 10) ratio of expression in the post-dose sample was generated relative to the reference in both the Up and DOWN arms of the gene signature. A log ratio value of zero indicated no change in the expression between the two samples. GFS was calculated as the mean log ratio of genes in the UP arm minus mean log ratio of genes in the Down arm. GFS was compared for paired samples (pre-dose and post-dose) by a T-statistic calculated as the GFS divided by its standard error. Responders to therapy had a T-statistic that was smaller than the threshold 1st percentile of student's T-distribution and were counted as having a decrease in GFS.|Up to 12 Days Post-dose|All participants who received a single dose of dalotuzumab and had evaluable baseline and post-dose biopsy samples.||Percentage of participants||80% Confidence Interval|Number
775913|NCT00759811|Secondary|Incidence of Adverse Effects of the Treatment||12 weeks||||||
775914|NCT00759811|Secondary|Incidence of All Cause Mortality, Hospitalization for Worsening Heart Failure, Myocardial Infarct, Stroke or Myocardial Revascularization Need||12 weeks||||||
775915|NCT00759811|Secondary|Reduction of Inflammatory Marker Measured Using C-reactive Protein Blood Levels||12 weeks||||||
775916|NCT00759811|Secondary|Improve in Quality of Life Measured Using the Brazilian Edition SF-36||12 weeks||||||
775917|NCT00759811|Secondary|Improve in Heart Failure Functional Class Measured Using New York Heart Association||12 weeks||||||
775918|NCT00759811|Primary|Change in Physical Capacity Measured Using the 6-minute Walk Test Distance|The primary outcome of the study was the difference in 6MWT distance before and after the treatment (change in meters evaluated by t test).|Baseline and 12 weeks|||meters||Standard Deviation|Mean
775919|NCT00759863|Secondary|Center for Epidemiologic Studies Depression Scale|The Center for Epidemiological Studies Depression scale (CES-D) is a 20-item measure that asks about the frequency of depressive symptoms (affective, psychological, and somatic) within the past week. The construct being assessed is the caregiver depression. Best value = 0. Worst Value = 60.|6 months|||Units on a scale||Standard Deviation|Mean
775920|NCT00759863|Secondary|Revised Memory and Behavior Problems Checklist|This scale measures the type/number of dementia patients disturbing behaviors, and how much they bother caregivers with 24 items describing possible troublesome behaviors that the patient might evidence in the past month. Caregivers are first asked whether the dementia patient had displayed any of these in the time period, and secondly to rate on a 5-point scale (0=not at all; 4= extremely) how much this “bothered or upset” them. A “conditional bother” score is calculated which is the “upset” or “bother” ratings for only the problematic behavior that occurred. Best value = 0. Worst Value = 96.|6 months|||Units on a scale||Standard Deviation|Mean
775921|NCT00759863|Primary|Multidimensional Observation Scale for Elderly Subject|"This scale reflects the overall well-being of dementia patients. The construct being assessed is the quality of life of dementia patients, related to patient functioning, disoriented behavior, depression/anxiety, irritable behavior, and withdrawn behavior, consisting of 32 items, divided in four sub-scales: Personal Care, Communication, Awareness & Memory, Mood, and Interpersonal Awareness Behaviors. The overall score provides an indication of the overall perceived well-being of the dementia patient. Best value = 32. Worst Value = 144."|6 months|||Units on a scale||Standard Deviation|Mean
775922|NCT00759902|Secondary|Area Under the Curve to Infinity for Plasma Morphine||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs|||hr*ng/mL||Standard Deviation|Mean
775923|NCT00759902|Secondary|Area Under the Curve to the Last Measurable Time Point for Plasma Morphine||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs|||hr*ng/mL||Standard Deviation|Mean
775924|NCT00759902|Secondary|Time of Maximum Plasma Morphine Concentration||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs|||hr||Full Range|Median
775925|NCT00759902|Primary|Maximum Plasma Morphine Concentration||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs|||ng/mL||Standard Deviation|Mean
775926|NCT00759915|Secondary|Area Under the Curve to Infinity for Plasma Morphine||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,36,48 hrs|||hr*ng/mL||Standard Deviation|Mean
775927|NCT00759915|Secondary|Area Under the Curve to the Last Measurable Time Point for Plasma Morphine||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs|||hr*ng/mL||Standard Deviation|Mean
775928|NCT00759915|Secondary|Time of Maximum Plasma Morphine Concentration||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs|||Hr||Full Range|Median
775929|NCT00759915|Primary|Maximum Plasma Morphine Concentration||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs|||ng/mL||Standard Deviation|Mean
775930|NCT00759941|Primary|Mean Change From Baseline in Intraocular Pressure, Diurnal, at 3 Months|Diurnal intraocular pressure is the mean of the three timepoints measured (8AM, 12PM & 4PM). Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in mean intraocular pressure.|Day 0, 3 months|All enrolled. Two subjects were excluded from the efficacy analysis due to an adverse event (1) and use of medication not permitted (1).||mmHg||Standard Deviation|Mean
776658|NCT00768066|Secondary|Serial Troponin Values (Every 12 Hours for the First 48 Hours Post-catheterization).||Measured every 12 hours for the first 48 hours post-catheterization|||ng/mL||95% Confidence Interval|Mean
775931|NCT00759941|Primary|Mean Change From Baseline in Intraocular Pressure, 4 PM, at 3 Months|Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in intraocular pressure.|Day 0, 3 months|All enrolled. Two subjects were excluded from the efficacy analysis due to an adverse event (1) and use of medication not permitted (1).||mmHg||Standard Deviation|Mean
775932|NCT00759941|Primary|Mean Change From Baseline in Intraocular Pressure, 12 PM, at 3 Months|Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in intraocular pressure.|Day 0, 3 months|All enrolled. Two subjects were excluded from the efficacy analysis due to an adverse event (1) and use of medication not permitted (1).||mmHg||Standard Deviation|Mean
775933|NCT00759941|Primary|Mean Change From Baseline in Intraocular Pressure, 8 AM, at 3 Months|Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in intraocular pressure.|Day 0, 3 months|All enrolled. Two subjects were excluded from the efficacy analysis due to an adverse event (1) and use of medication not permitted (1).||mmHg||Standard Deviation|Mean
775934|NCT00759954|Secondary|Area Under the Curve to Infinity for Plasma Morphine||0, 2, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10, 12, 18, 24, 30, 36, and 48 hrs post dose|||ng*hr/mL||Standard Deviation|Mean
775935|NCT00759954|Secondary|Area Under the Curve to the Last Measurable Time Point for Plasma Morphine|calculated from drug concentration over time|2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose|||ng*hr/mL||Standard Deviation|Mean
775936|NCT00759954|Secondary|Time of Maximum Plasma Morphine Concentration|calculated from drug concentration over time|2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose|Subjects completed the study without protocol violations.||hour||Full Range|Median
775937|NCT00759954|Primary|Maximum Plasma Morphine Concentration|calculated from drug concentration over time|2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose|||ng/mL||Standard Deviation|Mean
775938|NCT00759967|Secondary|To Determine if the Enhance Control of Blood Pressure With Daily Hemodialysis Compare to Conventional Hemodialysis is Associated With a Reduction in Markers of Inflammation||once the final participant has completed all intervention procedures, approx. 3 months|||pg/mL||Inter-Quartile Range|Median
775939|NCT00759967|Secondary|To Determine Patient Modality Preference.|each participant will complete a questionaire regarding modality preference|at study completion|The trial did not include a questionnaire regarding modality preference as originally planned|||||
775940|NCT00759967|Secondary|To Determine if the Enhance Control of Blood Pressure With Daily Hemodialysis Compare to Conventional Hemodialysis is Associated With a Reduction in Oxidative Stress.||once the final participant has completed all intervention procedures, approx. 3 months|||mmol/ml MDA equivalent||Inter-Quartile Range|Median
775941|NCT00759967|Secondary|To Determine if Short Daily Hemodialysis, Compared to Conventional Hemodialysis Maintains Metabolic Homeostasis|Serum phosphate values from the end of the three month run in phase and after randomization used to measure metabolic homeostasis|once the last participant has completed run in phase and after randomization, approx. 3 months|||mmol/Litre||Standard Deviation|Mean
775942|NCT00759967|Secondary|To Determine if the Mechanism by Which Short Daily Hemodialysis is Associated With Changes in Extracellular Fluid Volume|The extracellular fluid volume will be measured using bioelectrical impedance to determine if the mechanism by which short daily hemodialysis is associated with an improvement in blood pressure control is secondary to changes in extracellular fluid volume.|once the final participant has completed all intervention procedures, approx. 3 months|||Litres||Standard Deviation|Mean
775943|NCT00759967|Primary|Mean Systolic Blood Pressure Over the Third Month of Each Treatment Arm|The average of 2 measurements taken pre each dialysis session in the third month of treatment were compared when the patients were on conventional hemodialysis compared to short daily hemodialysis. SBP was taken in accordance with guidelines from the Canadian Hypertension Society|Average of the last month of the 3 month intervention|||mm Hg||Standard Deviation|Mean
775944|NCT00760019|Primary|Flow-mediated, Endothelium-dependent Vasodilation|Flow-mediated, endothelium-dependent vasodilation (percentage increase in brachial artery diameter after a 5 minute ischemic stimulus) measured at the end of placebo treatment and end of salsalate treatment were compared.|Upon completion of 4 weeks of salsalate and placebo treatment|The ultrasound data for two subjects was inadequate for analysis. This determination was made prior to unblinding. The data for these two subjects were discarded, leaving 56 subjects for analysis.||percentage vasodilation||Inter-Quartile Range|Median
775945|NCT00760084|Primary|The Number of Subjects With Adverse Events|Generate safety information when patients were also taking concomitant medications and/or therapies without trial restrictions when decitabine was administered at a dose of 20 milligrams per meter squared (mg/m^2) over a 1-hour intravenous (IV) infusion for 5 consecutive days every 4 weeks in patients with MDS (< 30% blasts) or AML (> 30% blasts).|3 months|||participants|||Number
775946|NCT00761007|Secondary|Response of Overall IBS Symptom Relief in the Subgroup of Patients With IBS With Diarrhea (IBS-D) - 75% Rule|"Weekly binary question (yes/no): Did you have satisfactory relief of your overall IBS symptoms since the last visit?
Responder: report of satisfactory overall IBS symptom relief = Yes 3/4 weeks (75% rule)"|Four weeks|Intention-to-treat (ITT) subgroup of patients with IBS-D (N=234)||Participants|||Number
775947|NCT00761007|Post-Hoc|Response of Overall IBS Symptom Relief in the Subgroup of Patients With IBS-Diarrhea (IBS-D) and Pain at Baseline - 75% Rule|"Weekly binary question (yes/no): Did you have satisfactory relief of your overall IBS symptoms since the last visit?
Responder: report of satisfactory overall IBS symptom relief = Yes 3/4 weeks (75% rule)"|Four weeks|Intention-to-treat subgroup of patients with IBS-D and baseline pain score>1 (in a 5-point scale ranging from 0=no pain to 4=very severe) (N=189)||Participants|||Number
775948|NCT00761007|Secondary|Response of Overall IBS Symptom Relief - 75% Rule|"Weekly binary question (yes/no): Did you have satisfactory relief of your overall IBS symptoms since the last visit?
Responder: report of satisfactory overall IBS symptom relief = Yes 3/4 weeks (75% rule)"|Four weeks|Intention-to-Treat (N=544)||Participants|||Number
775949|NCT00761007|Primary|Response of Overall IBS Symptom Relief - 50% Rule|"Weekly binary question (yes/no): Did you have satisfactory relief of your overall IBS symptoms since the last visit?
Responder: report of satisfactory overall IBS symptom relief = Yes 2/4 weeks (50% rule)"|Four weeks|Intention-to-Treat (N=544)||Participants|||Number
787796|NCT00845663|Secondary|Injection Questionnaire Per Formulation and Per Time Point - Afraid of Needles|Categorized answer ranges from not at all to extremely.|Before and 24 hours post-dose|Intent-to-treat population||Participants|||Number
775950|NCT00761137|Secondary|Percentage Change in Saliva Volume|Saliva volume was measured at baseline and 75 minutes after treatment administration. Volumes were measured by using cotton rolls placed near each Stenton duct and below the tongue for 5 minutes; cotton rolls were centrifuged and the volume of saliva determined.|Before and 75 minutes after treatment administration|Percentage saliva volume change was determined in the last seven (7) patients enrolled.||percentage change of saliva volume||95% Confidence Interval|Median
775951|NCT00761137|Primary|Sialorrhea Visual Analogue Scale (VAS)|Saliva buccal assessment was evaluated by an VAS scale before, and 15, 30, 45, 60, 90, and 120 min after treatment administration. Subjects were asked to rate how much saliva they perceived in their buccal cavity on an unmarked 0 to 10 cm line, higher scores meaning greater perceived buccal saliva levels.|Before and 120 min after treatment administration|||cm on VAS||Standard Deviation|Mean
775952|NCT00761150|Secondary|Change From Double-blind (DB) Baseline to Final Assessment in Chronic Pain Sleep Inventory (CPSI)|The change from the DB randomization baseline (DB baseline: the last assessment before first dose in the DB period) to the final assessment of the impact of pain on the participant's sleep. The CPSI utilizes a 100 mm VAS scale for questions of how often the participant had trouble falling asleep because of pain, needed sleeping medication, was awakened by pain during the night, and was awakened by pain in the morning (0 mm = Never and 100 mm = Always); and for rating the overall quality of sleep (0 mm = Very Poor and 100 mm = Excellent). Least squares means and standard errors from 2-way ANCOVA model without interaction.|Double-blind baseline to 4 weeks|The analysis of the secondary outcome measure included all randomized participants who received at least 1 dose of study drug during the DB period (DB intent-to-treat), had a DB baseline assessment, and had at least 1 assessment during the DB period.||scores on a scale||Standard Error|Least Squares Mean
775953|NCT00761150|Primary|Change From Double-blind (DB) Baseline to Final Assessment in Chronic Lower Back Pain (CLBP) Intensity by Visual Analog Scale (VAS)|The change from the DB randomization baseline (DB baseline: the last assessment before first dose in the DB period) to the final assessment in pain intensity, assessed using the CLBP Intensity VAS (0 mm = No Pain and 100 mm = Worst Pain Imaginable). Least squares means and standard errors from 2-way ANCOVA model without interaction.|Double-blind baseline to 4 weeks|The analysis of the primary outcome measure included all randomized participants who received at least 1 dose of study drug during the double-blind period (double-blind intent-to-treat).||scores on a scale||Standard Error|Least Squares Mean
775954|NCT00761176|Primary|The Incidence of Wounds Reaching Complete Closure||approximate one year|Analysis was not done as this study was early terminated due to all subjects not meeting inclusion/exclusion criteria.|||||
775955|NCT00761189|Secondary|Number of Participants With Categorical Scores Based on Clinical Global Impression - Improvement (CGI-I) Scale - Per Protocol (PP) Population|The CGI-I is a 7-point scale that requires the clinician to assess how much the participant’s illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.|Week 12|"Per protocol (PP) population included all the participants who received paliperidone extended-release (ER) at least once and who completed the clinical study without violating the study protocol. N (number of participants analyzed) signifies the participants evaluable for this measure."||Participants|||Number
775956|NCT00761189|Secondary|Number of Participants With Categorical Scores Based on Clinical Global Impression - Improvement (CGI-I) Scale - Intent-to-treat (ITT) Population|The CGI-I is a 7-point scale that requires the clinician to assess how much the participant’s illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.|Week 12|Intent to Treat (ITT) population for efficacy included all the eligible participants who received paliperidone extended-release (ER) at least once and who completed post baseline efficacy assessments.||Participants|||Number
775957|NCT00761189|Secondary|Clinical Global Impression - Severity (CGI-S) Score - Per Protocol (PP) Population|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher scores indicate worsening."|Baseline, Week 2, 4, 8 and 12|Per protocol (PP) population included all the participants who received paliperidone extended-release (ER) at least once and who completed the clinical study without violating the study protocol.||Units on a scale||Standard Deviation|Mean
775958|NCT00761189|Secondary|Clinical Global Impression - Severity (CGI-S) Score - Intent-to-treat (ITT) Population|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher scores indicate worsening."|Baseline, Week 2, 4, 8 and 12|Intent to Treat (ITT) population for efficacy included all the eligible participants who received paliperidone extended-release (ER) at least once and who completed post baseline efficacy assessments.||Units on a scale||Standard Deviation|Mean
775959|NCT00761189|Secondary|Drug Attitude Inventory (DAI) Score - Per Protocol (PP) Population|The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. It is the binary scale assessing the participant's subjective response. A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive subjective response (SR); a negative sum of scores indicates a negative SR (non-compliant). The final score is the grand total of the positive and negative points. Total score ranges from (-) 10 to (+) 10, higher score indicates positive SR (compliant) and lower score indicates negative SR (non-compliant).|Baseline, Week 4 and 12|"Per protocol (PP) population included all the participants who received paliperidone extended-release (ER) at least once and who completed the clinical study without violating the study protocol. N (number of participants analyzed) signifies the participants evaluable for this measure."||Units on a scale||Standard Deviation|Mean
775973|NCT00761215|Secondary|Microbiological Recurrence at Late Follow-up in Clinical Modified Intent to Treat Analysis Set||21-28 days after last study drug|The clinical modified intent to treat analysis set includes data from all participants who received study drug and had a diagnosis of complicated skin and skin structure infection. Microbiological samples not available from all participants.||Percentage of participants||95% Confidence Interval|Number
775974|NCT00761215|Secondary|Population PK||Multiple||||||
775960|NCT00761189|Secondary|Drug Attitude Inventory (DAI) Score - Intent-to-treat (ITT) Population|The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. It is the binary scale assessing the participant's subjective response. A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive subjective response (SR); a negative sum of scores indicates a negative SR (non-compliant). The final score is the grand total of the positive and negative points. Total score ranges from (-) 10 to (+) 10, higher score indicates positive SR (compliant) and lower score indicates negative SR (non-compliant).|Baseline, Week 4 and 12|"Intent to Treat (ITT) population for efficacy included all the eligible participants who received paliperidone extended-release (ER) at least once and who completed post baseline efficacy assessments. N (number of participants analyzed) signifies the participants evaluable for this measure."||Units on a scale||Standard Deviation|Mean
775961|NCT00761189|Secondary|Percentage of Participants Continuously Treated With 6 Milligram Per Day Regimen Until Week 12 - Per Protocol (PP) Population|Percentage of participants who were continuously treated with paliperidone extended-release (ER) 6 milligram per day regimen until week 12 are reported here.|Week 12|Per protocol (PP) population included all the participants who received paliperidone extended-release (ER) at least once and who completed the clinical study without violating the study protocol.||Percentage of Participants|||Number
775962|NCT00761189|Secondary|Percentage of Participants Continuously Treated With 6 Milligram Per Day Regimen Until Week 12 - Intent-to-treat (ITT) Population|Percentage of participants who were continuously treated with paliperidone extended-release (ER) 6 milligram per day regimen until Week 12 are reported here.|Week 12|Intent to Treat (ITT) population for efficacy included all the eligible participants who received paliperidone extended-release (ER) at least once and who completed post baseline efficacy assessments.||Percentage of participants|||Number
775963|NCT00761189|Secondary|Personal and Social Performance (PSP) Scale Score - Per Protocol (PP) Population|The PSP scale assesses the degree of dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less or equal to 30, functioning so poorly as to require intensive supervision.|Baseline, Week 4 and Week 12|Per protocol (PP) population included all the participants who received paliperidone extended-release (ER) at least once and who completed the clinical study without violating the study protocol.||Units on a scale||Standard Deviation|Mean
775964|NCT00761189|Secondary|Personal and Social Performance (PSP) Scale Score - Intent-to-treat (ITT) Population|The PSP scale assesses the degree of dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less or equal to 30, functioning so poorly as to require intensive supervision.|Baseline, Week 4 and 12|Intent to Treat (ITT) population for efficacy included all the eligible participants who received paliperidone extended-release (ER) at least once and who completed post baseline efficacy assessments.||Units on a scale||Standard Deviation|Mean
775965|NCT00761189|Primary|Percentage of Participants Assessed as Very Much Improved or Much Improved Based on Clinical Global Impression-Improvement (CGI-I) Scale - Per Protocol (PP) Population|The CGI-I is a 7-point scale that requires the clinician to assess how much the participant’s illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.|Week 12|Per protocol (PP) population included all the participants who received paliperidone extended-release (ER) at least once and who completed the clinical study without violating the study protocol.||Percentage of participants|||Number
775966|NCT00761189|Primary|Percentage of Participants Assessed as Very Much Improved or Much Improved Based on Clinical Global Impression-Improvement (CGI-I) Scale - Intent-to-treat (ITT) Population|The CGI-I is a 7-point scale that requires the clinician to assess how much the participant’s illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.|Week 12|Intent to Treat (ITT) population for efficacy included all the eligible participants who received paliperidone extended-release (ER) at least once and who completed post baseline efficacy assessments.||Percentage of participants|||Number
775967|NCT00761202|Secondary|Lipid Layer Pattern Assessment|Lipid layer thickness as determined by lipid layer mixing pattern. A high mixing pattern = thick lipid layer.|Week 1, month 1|Intent to Treat Population||Lipid Layer Mixing Pattern||Full Range|Median
775968|NCT00761202|Secondary|Daily Eyedrop Usage|Average daily eyedrop use|Month 1|Intent to Treat Population||drops/day||Standard Deviation|Mean
775969|NCT00761202|Secondary|Ocular Comfort and Ocular Symptoms on Visual Analogue Scale|Mean comfort judged on a 100 point visual analogue scale (0=Very Poor, 100=Excellent)|week 1, month 1|Intent to Treat Population||Units on a scale||Standard Deviation|Mean
775970|NCT00761202|Secondary|Conjunctival Hyperaemia|Percentage of conjunctival response reported in terms of limbal hyperaemia for the worst responses over the area at each point on a five point scale (0=clear/white conjunctiva, 1=slight redness, 2=Mild redness, 3=Moderate redness, 4=Severe redness)|week 1, month 1|Intent to Treat Population||Percentage of Participants|||Number
775971|NCT00761202|Secondary|Corneal Staining by Fluorescein|Percentage of cases of limbal staining by sodium fluorescein at each point on a five point scale (0 = None, 1 = Trace, 2 = Mild, 3 = Moderate, 4 = Severe)|week 1, month 1|Intent to Treat Population||Percentage of Participants|||Number
775972|NCT00761202|Primary|Conjunctival Staining by Lissamine Green|Percentage of cases of limbal staining by lissamine green at each point on a five point scale (0 = None, 1 = Trace, 2 = Mild, 3 = Moderate, 4 = Severe)|week 1, month 1|Intent to Treat Population||Percentage of Participants|||Number
775975|NCT00761215|Secondary|To Evaluate the Safety Profile of Tedizolid Phosphate||Multiple||||||
787818|NCT00845832|Secondary|Change From Baseline to Week 48 in ESR|ESR is an acute phase reactant and is a measure of inflammation.|Baseline and Week 48|Data were not collected because the study was terminated early.|||||
775976|NCT00761215|Secondary|Clinical Outcome at the Late Follow-up Visit in the Clinical Modified Intent to Treat Analysis Set|Persistent clinical cure was defined as continuing favorable response.|21 to 28 days after the last study drug|The clinical modified intent to treat analysis set includes data from all participants who received study drug and had a diagnosis of complicated skin and skin structure infection. Microbiological samples not available from all participants.||Percentage of Participants|||Number
775977|NCT00761215|Secondary|Microbiological Response Rate at Test of Cure in the Microbiologically Evaluable Analysis Set|Satisfactory microbiological outcomes are eradication and presumed eradication|7-14 days after last dose of study drug|The microbiologically evaluable analysis set includes all participants who received study drug, had a diagnosis of complicated skin and skin structure infection, completed an assessment, had no confounding events or factors, and had a baseline Gram-positive bacterial pathogen.||Percentage of participants||95% Confidence Interval|Number
775978|NCT00761215|Secondary|Response Rate at End of Therapy|Clinical response was defined as resolution or improvement of signs and symptoms of the complicated skin and skin structure infection so that no further antibiotic therapy was required.|last day of study treatment|The clinical modified intent to treat analysis set includes data from all participants who received study drug and had a diagnosis of complicated skin and skin structure infection||Percentage of participants||95% Confidence Interval|Number
775979|NCT00761215|Primary|Clinical Response Rate at Test of Cure in the Clinical Modified Intent to Treat Analysis Set|Clinical response was defined as resolution or improvement of signs and symptoms of the complicated skin and skin structure infection so that no further antibiotic therapy was required.|7-14 days after last dose of study drug|The clinically modified intent to treat analysis set includes data from all participants who received study drug and had a diagnosis of complicated skin and skin structure infection.||Percentage of participants||95% Confidence Interval|Number
775980|NCT00761215|Primary|Clinical Response Rate at Test of Cure in the Clinically Evaluable Analysis Set|Clinical response was defined as resolution or improvement of signs and symptoms of the complicated skin and skin structure infection so that no further antibiotic therapy was required.|7 to 14 days after the last dose of study drug|The Clinically Evaluable analysis set includes data from all participants who had a diagnosis of cSSSI, received minimal study therapy, completed an assessment, and had no confounding events or factors.||Percentage of participants||95% Confidence Interval|Number
775996|NCT00761306|Secondary|Change From Baseline in MADRS Total Score After 52 Weeks of Treatment|The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe.|Baseline and Week 52|FAS; observed cases (OC)||units on a scale||Standard Deviation|Mean
775993|NCT00761306|Secondary|Proportion of Remitters at Week 52 (Remission Defined as a MADRS Total Score <=10)||Week 52|FAS; OC||percentage of patients|||Number
775994|NCT00761306|Secondary|Proportion of Responders at Week 52 (Response Defined as a >=50% Decrease in MADRS Total Score)||Week 52|FAS; OC||percentage of patients|||Number
775995|NCT00761306|Secondary|Change From Baseline in HAM-D-24 Total Score After 52 Weeks of Treatment|The Hamilton Depression Scale - 24 Items (HAM-D-24) measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 76. The higher the score, the more severe.|Baseline and Week 52|FAS; OC||units on a scale||Standard Deviation|Mean
775997|NCT00761306|Primary|Percentage of Patients Who Withdrew Due to Intolerance to Treatment||Baseline to Week 52|APTS||percentage of patients|||Number
775998|NCT00761306|Primary|Number of Patients With Adverse Events (AEs)||Up to 52 weeks and a 4-week safety follow-up period|APTS||participants|||Number
791682|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Sodium).||Baseline up to Month 7|||percentage of participants|||Number
775999|NCT00761319|Secondary|Percentage of Patients With Corneal Fluorescein Staining Score = 0|The corneal surface was assessed by the investigator and graded on a scale of 0-3, where 0 = Absent (no staining present) and 3 = Severe (>50% coverage). Percentage of patients with score = 0 at 90 days was calculated by dividing the number of patients with score = 0 by tht total number of patients analyzed.|Day 90|Intent to treat. All patients who received test article and had at least one on-therapy study visit were evaluable for the intent-to-treat analysis. Last-observation-carried-forward was used to impute values for dropouts and for missing data on a scheduled study visit during the masked treatment period.||Percentage of patients|||Number
776000|NCT00761319|Primary|Mean Change at Day 90 From Baseline (Day 0) in Ocular Surface Disease Index (OSDI) Score|The OSDI is a 12-question validated questionnaire (resultant overall 0-100 score) used to measure ocular symptoms, visual function, and environmental factors that may affect a patient's vision, where 0 = normal and 100 = severe. The OSDI questionnaire was administered at both visits and completed by the patient with no assistance from the office staff, physician, or anyone else. A negative number represents a perceived improvement in ocular health.|Day 0, Day 90|Intent to treat. All patients who received test article and had at least one on-therapy study visit were evaluable for the intent-to-treat analysis. Last-observation-carried-forward was used to impute values for dropouts and for missing data on a scheduled study visit during the masked treatment period.||Units on a scale||Standard Error|Mean
776001|NCT00761345|Secondary|To Measure Progression Free Survival and Overall Survival||Evaluate CT scans after every 2 cycles of therapy (about every 6 weeks) and long term follow up every 3 months once off treatment for survival||||||
776002|NCT00761345|Primary|To Determine the Dose Limiting Toxicities||weekly physician and nurse assessment and in between as needed until 30 days after treatment termination|27 patients (median age 64years and 15 male) with locally advanced or metastatic pancreatic cancer confined to the abdomen and an ECOG performance status of 0-1 who had received 0-1 prior regimens (without Gemcitabine or Erlotinib) and no prior radiotherapy were eligible.||participants|||Number
776003|NCT00761462|Primary|Incidence of Nervous System Events (Cumulative)|Any event within the MedDRA system organ class 'Nervous System disorders'. Each incidence includes number shown at the previous time point, plus any new patients with the event.|4-6 weeks after treatment / 1 year after treatment / 2 or 5 years after treatment|Patients valid for safety (all patients confirmed to have received at least one dose of study drug).||participants|||Number
776004|NCT00761462|Primary|Incidence of Arthropathy (Cumulative)|Arthropathy, as assessed by independent safety committee. The committee, after reviewing data related to musculoskeletal events, decided whether each patient had arthropathy or not. Each incidence includes number shown at previous time point, plus any new patients with the event. The 112/20 arthropathies are mentioned in the other Adverse Events section as well.|4-6 weeks after treatment / 1 year after treatment / 2 or 5 years after treatment|Patients valid for safety (all patients confirmed to have received at least one dose of study drug)||participants|||Number
776005|NCT00761514|Primary|Percent Change From Baseline to Week 24 in Average Score on Section 1 of the Modified Multi-Dimensional Health Assessment Questionnaire (mHAQ) That Includes Ratings of Sleep, Anxiety, Depression or Feeling Blue, and Ability to do Daily Activities.|Section 1 of the mHAQ includes subject ratings of difficulty in: dressing; getting out of bed; lifting a full glass to the mouth; walking outdoors on flat ground; bathing; bending to pick up clothes from floor; getting in/out of car, bus, train, plane; walking 2 miles; participating in sports and games; getting a good night's sleep; dealing with feelings of anxiety, being nervous; dealing with feelings of depression, feeling blue. Without any difficulty=0, With some difficulty=1, With much difficulty=2, Unable to do=3. Ratings are summed. The maximum total score is 39. Low total score is good.|Week 24 of treatment|Available subject data were used in calculations; 14 at Baseline and 7 at Week 24. Missing data were not imputed.||Percent change in average total score|||Number
776006|NCT00761514|Secondary|Percent Change From Baseline to Week 24 in Average Score on the Short Disease Activity Score|On visual analog scale (VAS), patient marks activity of rheumatoid arthritis in previous 24 hours (0 mm=no symptoms; 100 mm=very active). On another VAS, patient marks how much pain (0 mm=no pain; 100 mm=severe pain) he/she had because of the illness in previous week. Patient also marks tender joints and swollen joints on body diagrams. Number of swollen and painful joints and values on VAS are used with erythrocyte sedimentation rate to calculate the patient's global assessment of disease activity. High score indicates high activity.|Week 24 of treatment|Available subject data were used in calculations. Missing data were not imputed.||Percent change in average score|||Number
776007|NCT00761527|Primary|Participant Global Tolerability Assessment|"The participant’s global assessment of tolerability with the medication was assessed using a categorical scale as follows:
Excellent
Very Good
Good
Fair
poor
Parent or guardian of each participant followed up for a final visit after 14 days (Day 15) at which tolerability was rated and reported for entire treatment period. Number of participants in each category is presented."|Day 15|The Safety population included all participants who had taken at least one dose of Desloratadine Syrup (N=2978). For 31 participants, tolerability was not assessed.||Participants|||Number
776008|NCT00761527|Secondary|Investigator Assessment of Clinical Efficacy|Investigator assessment of clinical efficacy of Desloratadine Syrup in relieving participants' symptoms of either allergic rhinitis or chronic idiopathic urticaria at final visit (Day 15). The number of participants categorized by investigator as: improved, no improvement, or worsened was reported at Day 15.|Day 15|ITT Population, which consisted of all participants who had taken at least one dose of Desloratadine Syrup and had a post baseline clinical efficacy assessment (N=2956). For 4 participants, a clinical efficacy assessment was not reported.||Participants|||Number
776009|NCT00761527|Primary|Safety of Desloratadine Syrup Reported by Number of Participants Experiencing Adverse Events After 14 Days of Treatment|Safety was assessed by determining the incidence of all AEs which occurred between Baseline Visit (Day 1) & Final Visit (Day 15) & were recorded in Case Report Forms. Number of participants experiencing AEs were presented in several categories. Some AEs lead to discontinuation (d/c). Classification, causality & intensity for AEs were determined by investigator. A SAE was any adverse drug experience that resulted in any of the following: death; life-threatening condition; inpatient hospitalization/prolongation of existing hospitalization; persistent or significant disability/incapacity.|15 Days|The Safety population included all participants who had taken at least one dose of Desloratadine Syrup.||Participants|||Number
791683|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Platelet Count)||Baseline up to Month 7|||percentage of participants|||Number
776010|NCT00761527|Primary|Number of Adverse Events Reported By Category After 14 Days of Treatment|Safety was assessed by determining the incidence of all Adverse Events (AE) which occurred between Baseline Visit (Day 1) & Final Visit (Day 15) & were recorded in Case Report Forms. Total number of AEs reported were presented in several categories. Classification, causality & intensity for AEs were determined by investigator after obtaining sufficient information. A Serious Adverse Event (SAE) was any adverse drug experience that resulted in: death; life-threatening condition; inpatient hospitalization/prolongation of existing hospitalization; persistent or significant disability/incapacity.|15 Days|The Safety population included all participants who had taken at least one dose of Desloratadine Syrup.||Adverse Events|||Number
776011|NCT00761579|Secondary|Change From Baseline in Symptom Checklist 90-R (SCL90-R) at Week 48|The SCL90-R (Derogatis, 1992) measures 9 domains, including somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism, which provides a global index of distress, the Global Severity Index (GSI). SCL-90-R includes 90 items rated on 5-point scale, ranging from 0 (not at all) to 4 (extremely). Total scale score range from 0 to 360. Higher scores indicate worsening of disease. Total scale score range from 0 to 360. Higher scores indicate worsening of disease. Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 48|ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.||Units on a scale||Standard Deviation|Mean
776012|NCT00761579|Secondary|Change From Baseline in Sleep Quality at Week 48|Sleep quality was assessed by an 11-point visual analog scale. Participants indicated on the 11-point visual analog scale (score ranging from 0 to 100 millimeter) how well they have slept in the previous 7 days, from 0 (very badly) to 100 (very well); and how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 100 (all the time). Scores were averaged for the previous 7 days. Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 48|ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.||millimeter (mm)||Standard Deviation|Mean
776013|NCT00761579|Secondary|Change From Baseline in Daytime Drowsiness at Week 48|Daytime Drowsiness was assessed by an 11-point visual analog scale. Participants indicated on the 11-point visual analog scale (score ranging from 0 to 100 millimeter) how well they have slept in the previous 7 days, from 0 (very badly) to 100 (very well); and how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 100 (all the time). Scores were averaged for the previous 7 days. Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 48|ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.||millimeter (mm)||Standard Deviation|Mean
776014|NCT00761579|Secondary|Change From Baseline in Subjective Well-being Under Neuroleptic (SWN-20) Scale Score at Week 48|The SWN-20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self-control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood. Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 48|ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.||Units on a scale||Standard Deviation|Mean
776015|NCT00761579|Secondary|Change From Baseline in Drug Attitude Inventory (DAI-10) at Week 48|The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. It is the binary scale assessing the participant's subjective response. A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive subjective response (SR); a negative sum of scores indicates a negative SR (non-compliant). The final score is the grand total of the positive and negative points. Total score ranges from (-) 10 to (+) 10, higher score indicates positive SR (compliant) and lower score indicates negative SR (non-compliant). Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 48|"ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. N (number of participants analyzed) signifies the participants evaluable for this measure."||Units on a scale||Standard Deviation|Mean
776016|NCT00761579|Secondary|Change From Baseline in Personal and Social Performance Scale (PSP) Score at Week 48|The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty). Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 48|ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
776017|NCT00761579|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - General Psychopathology Subscale Score at Week 48|The PANSS General Psychopathology Subscale Score assesses 16 general psychopathology symptoms. The symptoms are rated on a 7-point scale, with a range of 16 (absent) to 112 (extreme psychopathology). Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 48|ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
776018|NCT00761579|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score at Week 48|The PANSS Negative Subscale assesses seven negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology). Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 48|ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
776019|NCT00761579|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score at Week 48|The PANSS Positive Subscale assesses seven positive-symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology). Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 48|ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
776020|NCT00761579|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 48|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening. Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 48|Intent to treat (ITT) population for efficacy included all the participants who received paliperidone extended-release (ER) at least once and who had at least 1 post baseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
776021|NCT00761592|Secondary|Duration of Action|Median Duration for decision to reinject|Interval between initial injection (Week 0) and final visit (Week 11 through Week 14)|Intention to Treat||Weeks||Standard Deviation|Median
776022|NCT00761592|Secondary|Changes From Baseline to Week 4 and Week 8 in Patient Global Assessment (PGA) Score|"Subjective satisfaction rating: -4: marked worsening, -3: moderate worsening, -2: marked worsening in symptoms, -1: mild worsening in symptoms, 0: no effect
+1: mild improvement in symptoms, +2: moderate improvement in symptoms, +3: mild improvement, +4: marked improvement. A positive change from baseline indicated improvement."|Baseline to Week 4 and 8|Intention to Treat||Points on Scale||Standard Deviation|Mean
776023|NCT00761592|Secondary|Change From Baseline to Week 4 and Week 8 in Total Jankovic Rating Scale (JRS) (Severity and Frequency Measured on a Scale of 0-4)|Jankovic Rating Scale Severity: 0 - None; 1 - Minimal; 2 - Mild; 3 - Moderate; 4 - Severe. Frequency: 0 - None; 1 - Slight increase; 2 - Fluttering duration less than 1 second; 3 - Spasm greater than 1 second and eyes open > 50% of waking time; 4 - Functionally blind. The range of the total score was from 0 (None) to 8 (Severe and Functionally Blind). A negative change from baseline indicated improvement.|Baseline to Week 4 and Week 8|Intention to Treat||Points on Scale||Standard Deviation|Mean
776024|NCT00761592|Secondary|Change From Baseline to Week 8 in Blepharospasm Disability Index|"Blepharospasm Disability Index is a validated 5-point (0-4) scale with six items (e.g., reading, driving a vehicle).
0 - no impairment, 1 - mild impairment, 2 - moderate impairment, 3 - severe impairment, 4 - not possible due to disease, N/A - Not applicable.
The total score ranged from 0 (no impairment) to 24 (not possible due to disease). A negative change from baseline indicated improvement."|Baseline to Week 8|Intention to Treat||Points on Scale||Standard Deviation|Mean
776025|NCT00761592|Primary|Change From Baseline to Week 4 in Blepharospasm Disability Index|"Blepharospasm Disability Index is a validated 5-point scale (0-4) with six items (e.g., reading, driving a vehicle).
0 - no impairment, 1 - mild impairment, 2 - moderate impairment, 3 - severe impairment, 4 - not possible due to disease, N/A - Not applicable.
The total score ranged from 0 (no impairment) to 24 (not possible due to disease). A negative change from baseline indicated improvement."|Baseline to Week 4|Intention to Treat||Points on Scale||Standard Deviation|Mean
776026|NCT00761605|Secondary|Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Score at Week 24|The CGI-I is a 7-point scale that requires the clinician to assess how much the participant’s illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|"The ITT population for efficacy included all the participants who received paliperidone extended-release (ER) at least once and who had at least 1 post baseline efficacy assessment. N (number of participants analyzed) signifies participants evaluable for this measure."||Units on a scale||Standard Deviation|Mean
776055|NCT00761930|Primary|Gingivitis Score|"Gingivitis score (GI)= Units on a scale 0 to 3 (0 = no inflammation,
1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding. GI scored=sum of GI scores divided by the number of sites (gingival gum line around the tooth)scored."|6 weeks|||Units on a scale||Standard Deviation|Mean
791684|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Eosinophils)||Baseline up to Month 7|||percentage of participants|||Number
776027|NCT00761605|Secondary|Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 24|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher scores indicate worsening. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics."|Baseline and Week 24|ITT population for efficacy included all the participants who received paliperidone extended-release (ER) at least once and who had at least 1 post baseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
776028|NCT00761605|Secondary|Change From Baseline in Krawiecka Scale Score at Week 24|Psychopathology of participants was assessed by Krawiecka scale. Psychopathology of participants was assessed by Krawiecka scale, score ranges from 0 to 16. Higher score indicates worsening of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
776029|NCT00761605|Secondary|Change From Baseline in Daytime Drowsiness Based on Visual Analog Scale at Week 24|Daytime Drowsiness was assessed by an 11-point visual analog scale. Participants indicated on the 11-point visual analog scale (score ranging from 0 to 100 millimeter) how well they have slept in the previous 7 days, from 0 (very badly) to 100 (very well); and how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 100 (all the time). Scores were averaged for the previous 7 days. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|"The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.N (number of participants analyzed) signifies participants evaluable for this measure."||Millimeter (mm)||Standard Deviation|Mean
776030|NCT00761605|Secondary|Change From Baseline in Sleep Quality Based on Visual Analog Scale at Week 24|Sleep quality was assessed by an 11-point visual analog scale. Participants indicated on the 11-point visual analog scale (score ranging from 0 to 100 millimeter) how well they have slept in the previous 7 days, from 0 (very badly) to 100 (very well); and how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 100 (all the time). Scores were averaged for the previous 7 days. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|"The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.N (number of participants analyzed) signifies participants evaluable for this measure."||Millimeter (mm)||Standard Deviation|Mean
776031|NCT00761605|Secondary|Change From Baseline in Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24|The SWN-20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self-control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|"The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.N (number of participants analyzed) signifies participants evaluable for this measure."||Units on a scale||Standard Deviation|Mean
776032|NCT00761605|Secondary|Change From Baseline in Total Personal and Social Performance (PSP) Score at Week 24|The PSP scale assesses the degree of dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less or equal to 30, functioning so poorly as to require intensive supervision. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|The ITT population for efficacy included all the participants who received paliperidone extended-release (ER) at least once and who had at least 1 post baseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
776033|NCT00761605|Primary|Change From Baseline in Symptom Checklist 90-R (SCL90-R) at Week 24|The SCL90-R (Derogatis, 1992) measures 9 domains, including somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism, which provides a global index of distress, the Global Severity Index (GSI). SCL-90-R includes 90 items rated on 5-point scale, ranging from 0 (not at all) to 4 (extremely). Total scale score range from 0 to 360. Higher scores indicate worsening of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|"Intent to treat (ITT) population for efficacy included all the participants who received paliperidone extended-release (ER) at least once and who had at least 1 post baseline efficacy assessment. N (number of participants analyzed) signifies the participants evaluable for this measure."||Units on a scale||Standard Deviation|Mean
776056|NCT00761930|Primary|Dental Plaque|Quigley Hein Method: Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth. Plaque score= sum of all scores divided by the number of sites (teeth) scored.|6 weeks|||Units on a scale||Standard Deviation|Mean
791685|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Neutrophils)||Baseline up to Month 7|||percentage of participants|||Number
776034|NCT00761631|Other Pre-specified|Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 2|Systemic events (any fever >=38 deg C, decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may have been represented in more than 1 category. Percentage of participants = number of participants reporting specified systemic event divided by number of participants reporting yes for at least 1 day or no for all days.|From the day of dose 2 (Day 1) to Day 7 of dose 2|Dose 2 Safety Population: all participants who received 2 doses of 13vPnC. 'N' (number of participants analyzed )=participants with known values for any systemic events. 'n'=number of participants with known values for specified systemic events for each group respectively. Participants may be represented in more than 1 category.||Percentage of participants|||Number
776035|NCT00761631|Other Pre-specified|Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1|Systemic events (any fever >=38 degrees [deg] Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary.|From the day of dose 1 (Day 1) to Day 7 of dose 1|Dose 1 Safety Population: all participants who received the first dose of 13vPnC. 'N' (number of participants analyzed )=participants with known values for any systemic events. 'n'=number of participants with known values for specified systemic events for each group respectively. Participants may be represented in more than 1 category.||Percentage of participants|||Number
776036|NCT00761631|Other Pre-specified|Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 2|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm).|From the day of dose 2 (Day 1) to Day 7 of dose 2|Dose 2 Safety Population: all participants who received 2 doses of 13vPnC. 'N' (number of participants analyzed )=participants with known values for any local reaction. 'n'=number of participants with known values for specified local reaction for each group respectively. Participants may be represented in more than 1 category.||Percentage of participants|||Number
776037|NCT00761631|Other Pre-specified|Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm).|From the day of dose 1 (Day 1) to Day 7 after dose 1|Dose 1 Safety Population: all participants who received the first dose of 13vPnC. 'N' (number of participants analyzed )=participants with known values for any local reaction. 'n'=number of participants with known values for specified local reaction for each group respectively. Participants may be represented in more than 1 category.||Percentage of participants|||Number
776038|NCT00761631|Primary|Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination in Group 3 and 4|Serotype-specific OPA GMTs for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were determined in the blood samples of all the participants using a microcolony OPA (mcOPA) assay. GMT (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for after dose 1 blood draw.|28 to 42 days after dose 1 for Group 3 and 4|EIP: participants who met all inclusion criteria, received all assigned doses of study vaccine;had at least 1 valid, determinate assay result from blood draw within 27-56 days after last scheduled vaccination for proposed analysis;no major protocol violations. N (number of participants analyzed)=participants with a determinate antibody titer.||titer||95% Confidence Interval|Geometric Mean
776039|NCT00761631|Primary|Comparison of Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Measured 1 Month After 13vPnC Vaccination in Group 3 Relative to Posttoddler Responses in Study 6096A1-3005 (NCT00444457)|Comparison of IgG concentrations 1 month after 13vPnC vaccination in group 3 of study 6096A1-3011 (NCT00761631) to posttoddler responses in 7-valent pneumococcal conjugate vaccine (7vPnC) group for 7 common serotypes and in combined 13vPnC groups for 6 additional serotypes of study 6096A1-3005 (NCT00444457) is not reported here because analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in study and described in Participant Flow and Baseline Characteristics modules.|28 to 42 days after dose 1||||||
776040|NCT00761631|Primary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Measured 1 Month After Vaccination in Group 3|Antibody GMC for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for after dose 1 blood draw.|28 to 42 days after dose 1 for Group 3|EIP: participants who met all inclusion criteria, received all assigned doses of study vaccine;had at least 1 valid, determinate assay result from blood draw within 27-56 days after last scheduled vaccination for proposed analysis;no major protocol violations. N (number of participants analyzed)=participants with determinate antibody concentration.||mcg/mL||95% Confidence Interval|Geometric Mean
776041|NCT00761631|Primary|Percentage of Participants Achieving Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After Vaccination in Group 1 and 2|Percentage of participants achieving world health organization (WHO) predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. Exact 2-sided CI based on observed proportion of participants.|28 to 42 days after dose 2 for Group 1 and 28 to 42 days after dose 1 for Group 2|Evaluable Immunogenicity Population (EIP): all participants who met all inclusion criteria, received all assigned doses of study vaccine, had at least 1 valid and determinate assay result from blood draw within 27-56 days after last scheduled vaccination for proposed analysis and no major protocol violations.||Percentage of participants||95% Confidence Interval|Number
787819|NCT00845832|Secondary|Change From Baseline to Week 48 in C-Reactive Protein (CRP)|CRP is an acute phase reactant and is a measure of inflammation.|Baseline and Week 48|Data were not collected because the study was terminated early.|||||
776042|NCT00761735|Primary|Mean Age at Attained Tanner Stages (Sexual Maturity) at End of LTFU (Last Observation) By Gender|The Tanner Stage (TS) defines physical measurements of sexual development based on external primary and secondary sex characteristics. Female participants are evaluated for breast development and pubic hair distribution and male participants are evaluated for genital development and pubic hair distribution, based on a 5-stage ordinal scale ranging from TS 1 (prepubertal/preadolescent characteristics) to TS 5 (mature or adult characteristics). Mean ages for attaining each TS in the normal population have been previously established based on measuring correlating reproductive hormone levels, and are expressed in years as follows for females (F) and males (M): TS 1= 7.1 (F+M); TS 2= 10.5 (F), 12.1 (M); TS 3= 11.6 (F), 13.6 (M); TS 4=, 12.3 (F), 15.1 (M); TS 5= 14.5 (F), 18 (M). To assess sexual maturation at the end of the LTFU (last observation), females and males were staged and the mean age at each TS attained was reported.|Last assessment of the Part 2 LTFU (up to 5 years)|All participants enrolled in the P02538 Part 2 LTFU with non-missing Tanner Stage data at the last observation (up to Year 5 of the LTFU) were analyzed.||years||Standard Deviation|Mean
776043|NCT00761735|Primary|Mean Body Mass Index (BMI) Percentiles of Participants Over LTFU|To determine long-term effects of the Part 1 treatment on BMI, changes in BMI during the Part 2 LTFU were evaluated using BMI percentiles based on 2000 Center For Disease Control growth charts for the general population.|Part 1 Pre-treatment Baseline, Part 2 LTFU Year 1, Part 2 LTFU Year 2, Part 2 LTFU Year 3, Part 2 LTFU Year 4, Part 2 LTFU Year 5, Last Available LTFU Visit (up to 5 years)|All participants enrolled in the P02538 Part 2 LTFU were evaluated in this analysis.||percentile||Standard Deviation|Mean
776044|NCT00761735|Primary|Mean Weight Percentiles of Participants Over LTFU|To determine long-term effects of the Part 1 treatment on weight, changes in weight during the Part 2 LTFU were evaluated using weight percentiles based on 2000 Center For Disease Control growth charts for the general population.|Part 1 Pre-treatment Baseline, Part 2 LTFU Year 1, Part 2 LTFU Year 2, Part 2 LTFU Year 3, Part 2 LTFU Year 4, Part 2 LTFU Year 5, Last Available LTFU Visit (up to 5 years)|All participants enrolled in the P02538 Part 2 LTFU were evaluated in this analysis.||percentile||Standard Deviation|Mean
776045|NCT00761735|Primary|Mean Height Percentiles of Participants Over LTFU|To determine long-term effects of the Part 1 treatment on height, changes in height during the Part 2 LTFU were evaluated using height percentiles based on 2000 Center For Disease Control growth charts for the general population.|Part 1 Pre-treatment Baseline, Part 2 LTFU Year 1, Part 2 LTFU Year 2, Part 2 LTFU Year 3, Part 2 LTFU Year 4, Part 2 LTFU Year 5, Last Available LTFU Visit (up to 5 years)|All participants enrolled in the P02538 Part 2 LTFU were evaluated in this analysis.||percentile||Standard Deviation|Mean
776046|NCT00761735|Primary|Number of Participants Who Relapsed At End of LTFU Year 5|Relapse was defined as Hepatitis C Virus ribonucleic acid (HCV-RNA) that was above the lower limit of quantitation at Year 5 of the LTFU.|Part 2 LTFU Year 5|Of 94 participants entering the P02538 Part 2 LTFU, 63 participants had achieved sustained virologic response (SVR) while in Part 1 of the study. 54 of these 63 participants completed 5 years of LTFU and were evaluated for relapse.||participants|||Number
776047|NCT00761748|Primary|Preference of the Two Urostomy Products|"Number of participants preferring the SenSura Uro 2 piece product or the reference Convatec 2 piece product.
The subjects are asked via the case report form (questionnaire) at the end of the second cross over period, which of the two products they preferred."|6 weeks|The Per protocol (PP) population is analysed. PP-criteria: Subjects fulfill the inclusion and exclusion criteria, do not seriously violate the protocol, are exposed to both products and are evaluable with respect to the primary endpoint (state preference). *One drop out was evaluable, as the subject tried both products and stated a preference.||participants|||Number
776048|NCT00761761|Secondary|Sensoril Treatment Will Secondarily Improve Any Residual Anxiety Symptoms|Symptoms of anxiety were measured using the Hamilton Anxiety Rating Scale (HARS). Minimum score = 0, Maximum score = 60. Higher scores on HARS indicate worse functioning|Baseline and 8 week treatment|Stable Bipolar Patients||units on a scale||Standard Deviation|Mean
776049|NCT00761761|Secondary|Sensoril Treatment Will Secondarily Improve Any Residual Symptoms of Mania.|Manic symptoms were measured using the Young Mania Rating Scale (YMRS). Minimum score = 0, Maximum score = 60. Higher scores on YMRS indicate worse functioning.|Baseline and 8 weeks treatment|Stable Bipolar Patients||units on a scale||Standard Deviation|Mean
776050|NCT00761761|Secondary|Sensoril® Treatment Will Secondarily Improve Any Residual Depressive Symptoms|Depressive symptoms were measured using the Montgomery-Asberg Depression Rating Scale (MADRS). Minimum score = 0, Maximum score = 60. Higher scores on MADRS indicate worse functioning.|Baseline and 8 week treatment|Stable Bipolar patients||units on a scale||Standard Deviation|Mean
776051|NCT00761761|Primary|Change From Baseline in Digit-Span Score at 8 Weeks|"Cognition was assessed using tests developed by The Cognition Group-(TCG); London, UK; and Delaware, USA. Testing procedures and consistency was assured by the same staff-patient dyad, and a TCG staff person had previously trained the research staff (Chengappa et al, 2012). A comprehensive cognitive battery was assessed. Details of these cognitive tests are available at http://www.cogtest.com, and are also described in other studies (Harvey et al, 2007, Lindenmayer et al, 2011, Chengappa et al, 2012). However, the results for Digit span which assesses short term or working memory are presented.
The raw scores for digit span ranges from a minimum of 2 to a maximum of 8. The Digit Span test measures working memory and the longer the span the better the cognition therefore the higher score is the better outcome."|8 week treatment|||units on a scale||Standard Error|Least Squares Mean
776052|NCT00761865|Secondary|Patient Satisfaction (Measured on a Visual Analog Scale)|Satisfaction on 0-10 scale with 10 being the best.|2 weeks post-sprain|||units on a scale||Full Range|Mean
776053|NCT00761865|Primary|Modified Karlsson Score|Ankle function score - range 0 to 100. Higher score is better ankle function.|2 weeks post-sprain|||units on a scale||Full Range|Mean
776054|NCT00761930|Primary|Bleeding Index (EIBI)|Eastman Interdental Bleeding Index Scores (EIBI) measures the number of interdental spaces that bleed, divided by number of interdental spaces studied to yield a score with a minimum of O and a maximum of 1 (0=no bleeding & 1= bleeding) The number of spots between teeth that bleed are divided by number of spots between teeth that are scored and may be expressed as a percent when multiplied by 100.|6 weeks|||Units on a scale||Standard Deviation|Mean
776168|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 9)|Feeling of nausea is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 9.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
776057|NCT00761956|Secondary|Return to Function (RtF) Via Knee Scoiety Score (Modified)|"Scores were calculated from responses on a modified Knee Society Score by the enrolled subjects for the stated visit intervals.
Grading for the Knee Society Score is based on a scale from 0-100 and results are estabalished follows: 80-100 = Excellent; 70-79 = Good; 60-69 = Fair; and Below 60 = Poor."|24 Months|There was one case in the CR Flex Fixed cohort and 3 in the CR Standard Knee cohort where the Return to Function was not complete. Therefore, the total number analyzed is 51 instead of 52 and 45 instead of 48 respectfully.||units on a scale||Standard Deviation|Mean
776058|NCT00761956|Primary|Postoperative Range of Motion (ROM)|The subject will have the operative joint's range of motion/movement assessed through a series of exercises and bends. The assessor will measure how far the joint bends/moves in each direction by degrees. The measurements are taken at each visit interval and recorded.|24 Months|There was one case in the CR Standard Knee cohort where the Range of Motion was not complete. Therefore, the total number analyzed is 47 and not 48.||degrees||Standard Deviation|Mean
776059|NCT00761969|Secondary|Incidence of Revascularization Procedures|Incidence of coronary, carotid and peripheral arterial revascularization procedures|5 years|||participants|||Number
776060|NCT00761969|Primary|Incidence of Major Cardiovascular Events|Total number of deaths, cardiovascular deaths, non-fatal myocardial infarctions, ischemic strokes and critical limb ischemia.|5 years:|||participants|||Number
776061|NCT00762021|Primary|9% LogMAR Best Corrected Visual Acuity (BCVA)|"Best spectacle corrected vision was recorded for each eye of the patients at above follow up visits. The Visual Acuity (VA) measurement was taken under low contrast (9%), which means that there was low contrast between the letters on the chart and the background.
VA is measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution. A lower logMAR value indicates better visual acuity."|24 months after surgery|Data for all patients completing the 24 month visit were analyzed.||LogMAR||Standard Deviation|Mean
776062|NCT00762021|Primary|100% LogMAR Best Corrected Visual Acuity (BCVA)|"Best spectacle corrected vision was recorded for each eye of the patients at above follow up visits. The Visual Acuity (VA) measurement was taken under high contrast (100%), which means that there was maximum contrast between the letters on the chart and the background.
VA is measured in logMAR. LogMAR is the “logarithm of the minimum angle of resolution”. A lower logMAR value indicates better visual acuity."|24 months after surgery|Data for all patients completing the 24 month visit were analyzed.||LogMAR||Standard Deviation|Mean
776063|NCT00762021|Primary|Posterior Capsule Opacification (PCO)|Thickening and opacification of the transparent membrane on which the intraocular lens is placed assessed by taking a digital retroillumination image of each eye with a dedicated retroillumination camera system. The photographs were analyzed with POCO software to measure the percentage area of PCO in the capsulorhexis area.|2 years after surgery|Data for all patients completing the 24 month visit were analyzed.||Percentage of PCO||Standard Deviation|Mean
776064|NCT00762034|Secondary|Translational Research: Overall Survival (OS) Based on Cytoplasmic and Membrane Folate Receptor Alpha (FR-α) Expression|Cytoplasmic and membrane Folate Receptor Alpha (FR-α) expression was measured using an Immunohistochemistry (IHC) assay which were scored using a 0 (negative, no staining) to 3+ (brightest staining) scoring system for cytoplasmic or membrane staining, and H score is a calculated using formula: 1x(percentage of cells stained 1+) + 2x(percentage of cells stained 2+) + 3x(percentage of cells stained 3+). FR-α Positive have an H score >0 and FR-α Negative have an H score=0. Overall survival (OS) is the duration from date of randomization to date of death from any cause. Participants were censored at the date they were last known to be alive.|Baseline to date of death from any cause (up to 37.06 months)|All randomized participants with FR-α Cytoplasm or Membrane H scores. Participants censored: FR-α Positive Cytoplasm n=21, 15 and Negative n=4, 3; FR-α Membrane Positive n=16, 8 and Negative n=9, 10 for Pem/Carbo/Bev and Pac/Carbo/Bev arms, respectively.||months||95% Confidence Interval|Median
776065|NCT00762034|Secondary|Translational Research: Overall Survival (OS) Based on Cytoplasmic and Nuclear Thymidylate Synthase (TS) Expression|Cytoplasmic and nuclear Thymidylate Synthase (TS) expression was measured using an Immunohistochemistry (IHC) assay which were scored using a 0 (negative, no staining) to 3+ (brightest staining) scoring system for cytoplasmic and nuclear staining, and H score was calculated using formula: 1x(percentage of cells stained 1+) + 2x(percentage of cells stained 2+) + 3x(percentage of cells stained 3+). TS Positive have an H score >0 and TS Negative have an H score=0. Overall survival (OS) is the duration from date of randomization to date of death from any cause. Participants were censored at the date they were last known to be alive.|Baseline to date of death from any cause (up to 37.06 months)|All randomized participants with TS Cytoplasm and Nucleus H scores. Participants censored: TS Cytoplasm Positive n=23, 20 and Negative n=4, 1; TS Nucleus Positive n=17, 9 and Negative n=10, 12 for the Pem/Carbo/Bev and Pac/Carbo/Bev arms, respectively.||months||95% Confidence Interval|Median
776066|NCT00762034|Secondary|Translational Research: Overall Survival (OS) Based on Nuclear Thyroid Transcription Factor-1 (TTF-1) Expression Regardless of Study Treatment|Nuclear Thyroid Transcription Factor-1 (TTF-1) expression was measured using an Immunohistochemistry (IHC) assay which were scored using a 0 (negative, no staining) to 3+ (brightest staining) scoring system, and H score is a calculated using formula: 1x(percentage of cells stained 1+) + 2x(percentage of cells stained 2+) + 3x(percentage of cells stained 3+). TTF-1 Positive have an H score >0 and TTF-1 Negative have an H score=0. Overall survival (OS) is the duration from date of randomization to date of death from any cause. Participants were censored at the date they were last known to be alive.|Baseline to date of death from any cause (up to 37.06 months)|All randomized participants with TTF-1 H scores regardless of study treatment. Participants censored: n=38, 11 in the TTF-1 Nuclear Positive and Negative arms, respectively.||months||95% Confidence Interval|Median
776067|NCT00762034|Secondary|Translational Research: Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations|Epidermal Growth Factor Receptor (EGFR) mutations were measured by polymerase chain reaction (PCR).|Baseline|All randomized participants with EGFR data regardless of study treatment.||participants|||Number
776068|NCT00762034|Secondary|Pharmacokinetics (PK): Bevacizumab Clearance (CL)||Cycle 1 (pre-dose, 0.75, 1.5, 3, 5, 7, 24, 48, 72, 168, 336, and 503 hours post-dose)|Randomized participants who received study drug and had evaluable CL data.||liters per day (L/day)||Geometric Coefficient of Variation|Geometric Mean
776259|NCT00762476|Secondary|Rhinovirus Infections.|The incidence of rhinovirus infections|10 weeks|All efficacy analyses were performed on the intent-to-treat (ITT).The ITT population included all enrolled subjects who received study treatment.||rhinovirus infections per 100 subjects|||Number
776069|NCT00762034|Secondary|Pharmacokinetics (PK): Area Under the Concentration Time Curve From Zero to Infinity (AUC(0-∞)) Bevacizumab||Cycle 1 (pre-dose, 0.75, 1.5, 3, 5, 7, 24, 48, 72, 168, 336, and 503 hours post-dose)|Randomized participants who received study drug and had evaluable AUC(0-∞) data.||microgram*day per milliliter (μg•day/mL)||Geometric Coefficient of Variation|Geometric Mean
776070|NCT00762034|Secondary|Pharmacokinetics (PK): Elimination Half-life (t1/2) for Bevacizumab||Cycle 1 (pre-dose, 0.75, 1.5, 3, 5, 7, 24, 48, 72, 168, 336, and 503 hours post-dose)|Randomized participants who received study drug and had evaluable t1/2 data.||days||Geometric Coefficient of Variation|Geometric Mean
776071|NCT00762034|Secondary|Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) for Bevacizumab||Cycle 1 (pre-dose, 0.75, 1.5, 3, 5, 7, 24, 48, 72, 168, 336, and 503 hours post-dose)|Randomized participants who received study drug and had evaluable Cmax data.||micrograms per milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
776072|NCT00762034|Secondary|Pharmacokinetics (PK): Platinum Clearance (CL) for Total (Bound and Unbound) and Unbound Forms|Platinum is a metabolite of Carboplatin (Carbo) and is found in the blood as both a bound and unbound form.|Cycle 1 (pre-dose, 0.25, 0.5, 0.67, 1.42, 2.17, 4, 6, 8, 24, 48, and 72 hours post-dose)|Randomized participants who received study drug and had evaluable CL data.||liters per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
776073|NCT00762034|Secondary|Pharmacokinetics (PK): Area Under the Concentration Time Curve From Zero to Infinity (AUC(0-∞)) for Total (Bound and Unbound) Platinum and Unbound Platinum|Platinum is a metabolite of Carboplatin (Carbo) and is found in the blood as both a bound and unbound form.|Cycle 1 (pre-dose, 0.25, 0.5, 0.67, 1.42, 2.17, 4, 6, 8, 24, 48, and 72 hours post-dose)|Randomized participants who received study drug and had evaluable AUC(0-∞) data.||microgram*hour per milliliter (μg•hr/mL)||Geometric Coefficient of Variation|Geometric Mean
776074|NCT00762034|Secondary|Pharmacokinetics (PK): Elimination Half-life (t1/2) for Total (Bound and Unbound) Platinum and Unbound Platinum|Platinum is a metabolite of Carboplatin (Carbo) and is found in the blood as both a bound and unbound form.|Cycle 1 (pre-dose, 0.25, 0.5, 0.67, 1.42, 2.17, 4, 6, 8, 24, 48, and 72 hours post-dose)|Randomized participants who received study drug and had evaluable t1/2 data.||hours (hr)||Geometric Coefficient of Variation|Geometric Mean
776075|NCT00762034|Secondary|Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) for Total (Bound and Unbound) Platinum and Unbound Platinum|Platinum is a metabolite of Carboplatin (Carbo) and is found in the blood as both a bound and unbound form.|Cycle 1 (pre-dose, 0.25, 0.5, 0.67, 1.42, 2.17, 4, 6, 8, 24, 48, and 72 hours post-dose)|Randomized participants who received study drug and had evaluable Cmax data.||micrograms per milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
776076|NCT00762034|Secondary|Pharmacokinetics (PK): Pemetrexed Clearance (CL)||Cycle 1 (pre-dose, 0.17, 0.33, 0.58, 0.83, 1, 1.75, 2.5, 4. 6. 8, and 24 hours post-dose)|Participants who were randomized to Pem/Carbo/Bev, who received study drug, and had evaluable CL data.||milliliters per minute (mL/min)||Geometric Coefficient of Variation|Geometric Mean
776077|NCT00762034|Secondary|Pharmacokinetics (PK): Area Under the Concentration Time Curve From Zero to Infinity (AUC(0-∞)) for Pemetrexed||Cycle 1 (pre-dose, 0.17, 0.33, 0.58, 0.83, 1, 1.75, 2.5, 4. 6. 8, and 24 hours post-dose)|Participants who were randomized to Pem/Carbo/Bev, who received study drug, and had evaluable AUC(0-∞) data.||microgram*hour per milliliter (μg•hr/mL)||Geometric Coefficient of Variation|Geometric Mean
776078|NCT00762034|Secondary|Pharmacokinetics (PK): Elimination Half-life (t1/2) for Pemetrexed||Cycle 1 (pre-dose, 0.17, 0.33, 0.58, 0.83, 1, 1.75, 2.5, 4. 6. 8, and 24 hours post-dose)|Participants who were randomized to Pem/Carbo/Bev, who received study drug, and had evaluable t1/2 data.||hours (hr)||Geometric Coefficient of Variation|Geometric Mean
776079|NCT00762034|Secondary|Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) for Pemetrexed||Cycle 1 (pre-dose, 0.17, 0.33, 0.58, 0.83, 1, 1.75, 2.5, 4. 6. 8, and 24 hours post-dose)|Participants who were randomized to Pem/Carbo/Bev, who received study drug, and had evaluable Cmax data.||micrograms per milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
776080|NCT00762034|Secondary|Change From Baseline in Participant Reported Outcomes as Assessed by the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group- Neurotoxicity (FACT/GOG-Ntx)|FACT/GOG-Ntx is a validated instrument used to measure quality of life (QOL) in participants with cancer and neurotoxicity (Ntx) consisting of 27-item FACT-General (G) and 11-item Ntx subscale. FACT-G is organized into domain subscales: physical well-being (PWB)–7 items; social/family well-being (SWB)–7 items; emotional well-being (EWB)–6 items; functional well-being (FWB)–7 items; each uses a 5 point rating scale (0=“not at all” and 4=equals “very much”). FACT/GOG-Ntx Total Score=sum 5 subscales and ranges from 0-152. Ntx Trial Outcome Index (TOI-Ntx)=PWB+FWB+NTX and range from 0-100. For all FACT scales, higher scores indicate better QOL. Least squares mean (LSmean) change is calculated using the linear-mixed model (LMM) analysis controlled for treatment, baseline value, time point and treatment by time point interaction.|Baseline, up to first 10 cycles (4 induction and 6 maintenance cycles, cycle=21 days)|The LMM analysis includes data from all participants in each arm for whom a validated translation is available in a language in which the completer (participant) is fluent and have evaluable FACT/GOG-Ntx data, using the intent-to-treat principle.||units on a scale||Standard Error|Least Squares Mean
776081|NCT00762034|Secondary|Change From Baseline in Participant Reported Outcomes as Assessed by the Functional Assessment of Cancer Therapy - Lung (FACT-L)|FACT-L is a valid instrument used to measure quality of life (QOL) in participants with cancer consisting of the 27-item FACT-General (G) and 9-item lung cancer subscale (LCS). FACT-G is organized into subscales: physical well-being (PWB)–7 items; social/family well-being (SWB)–7 items; emotional well-being (EWB)–6 items; functional well-being (FWB)–7 items. Each item uses a 5 point rating scale (0=“not at all” and 4=equals “very much”). FACT-L Total Score=4 subscales + LCS and ranges from 0 to 144. Trial Outcome Index-Lung (TOI-L)=PWB+FWB+LCS and ranges from 0 to 92. Higher scores indicate better QOL. Least squares mean (LSmean) change is calculated using the linear-mixed model (LMM) analysis controlled for treatment, baseline value, time point and treatment by time point interaction.|Baseline, up to first 10 cycles (4 induction and 6 maintenance cycles, cycle=21 days)|The LMM analysis includes data from all participants in each arm for whom a validated translation is available in a language in which the completer (participant) is fluent and have evaluable FACT-L, using the intent-to-treat principle.||units on a scale||Standard Error|Least Squares Mean
776275|NCT00762606|Secondary|Corneal Astigmatism|Analysis of corneal astigmatism 12 months after surgery using Orbscan Topography. A lower corneal astigmatism value is better.|3 months after surgery|||Diopters||Standard Deviation|Mean
776082|NCT00762034|Secondary|Change From Baseline in Participant Reported Outcomes as Assessed by the Functional Assessment of Cancer Therapy - General (FACT-G)|"The FACT-G is a validated instrument used to measure quality of life (QOL) in participants with cancer consisting of the 27-item questionnaire and is organized into subscales, each designed to assess a QOL domain: physical well-being (PWB)-7 items; social/family well-being (SWB)-7 items; emotional well-being (EWB)-6 items; functional well-being (FWB)-7 items. Each item uses a 5 point rating scale (0=not at all and 4=equals very much). FACT-G Total is the sum of the scores of all 4 subscales and ranges from 0 to 108. Higher scores indicate better QOL. Least squares mean (LSmean) change is calculated using the linear-mixed model (LMM) analysis controlled for treatment, baseline value, time point and treatment by time point interaction."|Baseline, up to first 10 cycles (4 induction and 6 maintenance cycles, cycle=21 days)|The LMM analysis includes data from all participants in each arm for whom a validated translation is available in a language in which the completer (participant) is fluent and have evaluable FACT-G data, using the intent-to-treat principle.||units on a scale||Standard Error|Least Squares Mean
776083|NCT00762034|Secondary|Number of Participants Receiving Concomitant Medication||Baseline to study endpoint (up to 37.06 months)|All randomized participants||participants|||Number
776084|NCT00762034|Secondary|Number of Participants Who Received a Transfusion||Baseline to study endpoint (up to 37.06 months)|All randomized participants who received at least 1 dose of study drug.||participants|||Number
776085|NCT00762034|Secondary|Duration of Hospitalizations Per Participant|Length of hospitalization in participants hospitalized during the study or within 30 days of discontinuation regardless of whether the hospitalization was or was not due to study drug.|Baseline to study endpoint (up to 37.06 months)|All randomized participants who received at least 1 dose of study drug and had at least one hospitalization while on study or within 30 days of discontinuation.||days||Standard Deviation|Mean
776086|NCT00762034|Secondary|Safety and Toxicity Profile of Study Treatments|Safety and toxicity profile was defined as serious and other non-serious adverse events. A summary of serious and all other non-serious adverse events is located in the Reported Adverse Event module.|Baseline to study endpoint (up to 37.06 months)|All randomized participants who received at least 1 dose of study drug during the specified treatment phase.||participants|||Number
776087|NCT00762034|Secondary|Time to Progressive Disease|Time to progressive disease was defined as the time from randomization to the first date of objective disease progression. Participants were censored at date of last PFS assessment prior to the cutoff date or the date of initiation of subsequent systemic anticancer therapy, whichever was earlier.|Baseline to measured progressive disease (up to 37.06 months)|All randomized participants using the intent-to-treat principle. Number of participants censored: n=198, 172 in Pem/Carbo/Bev and Pac/Carbo/Bev arms, respectively.||months||95% Confidence Interval|Median
776088|NCT00762034|Secondary|Progression Free Survival Time|Progression free survival (PFS) is defined as the time from date of randomization to the date of objective disease progression or death due to any cause. Participants were censored at date of last PFS assessment prior to the cutoff date or the date of initiation of subsequent systemic anticancer therapy, whichever was earlier.|Baseline to measured progressive disease or date of death from any cause (up to 33.54 months)|All randomized participants using the intent-to-treat principle. Number of participants censored: n=127, 109 in Pem/Carbo/Bev and Pac/Carbo/Bev arms, respectively.||months||95% Confidence Interval|Median
776089|NCT00762034|Secondary|Percentage of Participants With a Complete Response (CR), Partial Response (PR), and Stable Disease (SD) (Disease Control Rate)|Disease Control Rate (DCR) is the number of participants with a Complete Response (CR), Partial Response (PR), and Stable Disease (SD) divided by the total number of randomized participants per arm, then multiplied by 100. Response is based on the Response Evaluation Criteria In Solid Tumors (RECIST 1.0) criteria. Complete Response (CR) was defined as the disappearance of all target lesions. Partial Response (PR) was defined as at least a 30% decrease in sum of longest diameter of target lesions compared with baseline or the complete disappearance of target lesions, with persistence of 1 or more nontarget lesion(s) and no new lesions. Progressive Disease (PD) was defined as at least 20% increase in sum of longest diameter of target lesions compared with the smallest sum of the longest diameter recorded since the start of treatment or the appearance of 1 or more new lesion(s). Stable Disease (SD) was defined as small changes that did not meet above criteria.|Baseline to measured progressive disease (up to 37.06 months)|All randomized participants using the intent-to-treat principle||percentage of participants||95% Confidence Interval|Number
776090|NCT00762034|Secondary|Percentage of Participants With a Complete Response (CR) and Partial Response (PR) (Overall Response Rate)|Overall Response Rate (ORR) is the number of participants with a Complete Response (CR) and Partial Response (PR) divided by the total number of randomized participants per arm, then multiplied by 100. Response is based on the Response Evaluation Criteria In Solid Tumors (RECIST 1.0) criteria. Complete Response (CR) was defined as the disappearance of all target lesions. Partial Response (PR) was defined as at least a 30% decrease in sum of longest diameter of target lesions compared to baseline or the complete disappearance of target lesions, with persistence of 1 or more nontarget lesion(s) and no new lesions.|Baseline to measured progressive disease (up to 37.06 months)|All randomized participants using the intent-to-treat principle||percentage of participants||95% Confidence Interval|Number
776091|NCT00762034|Primary|Overall Survival|Overall survival (OS) is the duration from date of randomization to date of death from any cause. Participants were censored at the date they were last known to be alive.|Baseline to date of death from any cause (up to 37.06 months)|All randomized participants using the intent-to-treat principle. Number of participants censored: n=131, 127 in Pem/Carbo/Bev and Pac/Carbo/Bev arms, respectively.||months||95% Confidence Interval|Median
776092|NCT00762073|Secondary|Mean Change in Blood Pressure (BP) at End of Treatment|BP was assessed for each treatment group at baseline and at each post-baseline visit including the final treatment evaluation.|Baseline, 12 weeks after the start of treatment|The Safety Analysis Set, defined as all randomized participants who received at least one dose of double-blind study drug.||mmHg||Standard Deviation|Mean
776093|NCT00762073|Secondary|Percent of Participants With Potential Corticosteroid-Related Treatment-Emergent Adverse Events (TEAEs)|Corticosteroid-Related TEAEs included candidiasis, oesophageal candidiasis, crying, psychomotor hyperactivity, aggression, anger, anxiety, conduct disorder, emotional disorder, insomnia, or mood altered mood. Corticosteroid-Related TEAEs were assessed systematically during the treatment and taper periods.|15 weeks after the start of treatment|The Safety Analysis Set, defined as all randomized participants who received at least one dose of double-blind study drug.||percentage of participants|||Number
776094|NCT00762073|Secondary|Area Under The Plasma Concentration-Time Curve (AUC) of Budesonide From Time Zero to Time of The Last Measurable Concentration (AUC0-last)|On the day that pharmacokinetic (PK) blood samples were obtained, each participant delayed the morning dose of study medication until instructed to dose in the clinic. The sampling timepoints included pre-dose (0), and 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose. The lower limit of quantitation (LLOQ) for the analytical method was approximately 20 pg/mL in plasma using 0.2 mL of the sample. Because the PK analyses for the medium and high dose oral budesonide suspension (OBS) groups were based on plasma samples collected following administration of identical single doses of OBS, the data for the medium-dose group (OBS once-daily) and high-dose group (OBS twice-daily) were summarized together.|Week 2, 4, or 8, or at the Final Treatment Evaluation|The PK Set, defined as all participants in the safety analysis set who received oral budesonide suspension (OBS) and had sufficient PK samples to calculate PK parameters.||hr*pg/mL||Standard Deviation|Mean
776095|NCT00762073|Secondary|Time to Maximum (Tmax) And Half Maximum (T1/2) Plasma Concentration of Budesonide|On the day that pharmacokinetic (PK) blood samples were obtained, each participant delayed the morning dose of study medication until instructed to dose in the clinic. The sampling timepoints included pre-dose (0), and 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose. The lower limit of quantitation (LLOQ) for the analytical method was approximately 20 pg/mL in plasma using 0.2 mL of the sample. Because the PK analyses for the medium and high dose oral budesonide suspension (OBS) groups were based on plasma samples collected following administration of identical single doses of OBS, the data for the medium-dose group (OBS once-daily) and high-dose group (OBS twice-daily) were summarized together. T1/2 is the time to terminal elimination half-life.|Week 2, 4, or 8, or at the Final Treatment Evaluation|The PK Set, defined as all participants in the safety analysis set who received oral budesonide suspension (OBS) and had sufficient PK samples to calculate PK parameters.||hours||Standard Deviation|Mean
776096|NCT00762073|Secondary|Maximum Plasma Concentration (Cmax) of Budesonide|On the day that pharmacokinetic (PK) blood samples were obtained, each participant delayed the morning dose of study medication until instructed to dose in the clinic. The sampling timepoints included pre-dose (0), and 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose. The lower limit of quantitation (LLOQ) for the analytical method was approximately 20 pg/mL in plasma using 0.2 mL of the sample. Because the PK analyses for the medium and high dose oral budesonide suspension (OBS) groups were based on plasma samples collected following administration of identical single doses of OBS, the data for the medium-dose group (OBS once-daily) and high-dose group (OBS twice-daily) were summarized together.|Week 2, 4, or 8, or at the Final Treatment Evaluation|The Pharmacokinetic (PK) Set, defined as all participants in the safety analysis set who received oral budesonide suspension (OBS) and had sufficient PK samples to calculate PK parameters.||pg/mL||Standard Deviation|Mean
776097|NCT00762073|Secondary|Change From Baseline in Physician's Global Assessment Score of Disease Severity|"Physician investigators were asked to complete a visual analog scale (VAS) to provide a global assessment of eosinophilic esophagitis (EoE) activity in each participant. The VAS was a 100-mm horizontal line on which the right extreme (100) was labeled “worst possible disease activity” and the left (0) was labeled “no disease activity.” Investigators were instructed to consider the line for the VAS as a continuum with their own opinion of extremes on either end. Investigators drew a vertical line at a point that best approximated the participant's current level of EoE disease activity. The investigator was to take into consideration how esophageal disease was impacting the participant’s daily activities. The following instruction was given to the investigators: Using the visual analog scale below, please mark a vertical line on the scale to indicate your assessment of EoE activity in this participant at this time. A negative change from baseline indicates that symptoms decreased."|Baseline, 12 weeks after the start of treatment|The FAS, defined as all participants who received at least one dose of study drug and had evaluable post-baseline esophageal biopsy and clinical symptom data.||scores on a scale||Standard Deviation|Mean
776098|NCT00762073|Secondary|Percent Change From Baseline in Eosinophilic Esophagitis (EoE) Clinical Symptom Score (CSS)|"The EoE CSS, scored from 0 to 18 by a doctor, assessed 6 categories: 1) heartburn, 2) abdominal pain, 3) nocturnal awakening with symptoms, 4) nausea, regurgitation, or vomiting, 5) anorexia or early satiety, and 6) dysphagia, odynophagia, or food impaction (a severe symptom). Each domain was scored as follows, based on symptoms in the 2 weeks prior to the assessment:
0 = No symptoms and no coping behaviors required; 1= Mild: Symptoms limited to 1-3 days or no symptoms because coping behaviors were required to avoid symptoms; 2= Moderate: Symptoms on >3 days, with or without minor coping behaviors; 3= Severe: Symptoms interfered with activities of daily living or symptoms persisted and required major coping behaviors.
A negative change from baseline indicates that symptoms decreased."|Baseline, 12 weeks after the start of treatment|The FAS, defined as all participants who received at least one dose of study drug and had evaluable post-baseline esophageal biopsy and clinical symptom data.||percent change||Standard Deviation|Mean
776099|NCT00762073|Secondary|Percent of Participants With Clinical Remission|"Clinical remission was defined as an eosinophilic esophagitis (EoE) clinical symptom score (CSS) of zero. EoE CSS, scored from 0 to 18 by a doctor, assessed 6 categories: 1) heartburn, 2) abdominal pain, 3) nocturnal awakening with symptoms, 4) nausea, regurgitation, or vomiting, 5) anorexia or early satiety, and 6) dysphagia, odynophagia, or food impaction (a severe symptom). Each domain was scored as follows, based on symptoms in the 2 weeks prior to the assessment:
0 = No symptoms and no coping behaviors required; 1 = Mild: Symptoms limited to 1-3 days or no symptoms because coping behaviors were required to avoid symptoms; 2 = Moderate: Symptoms on >3 days, with or without minor coping behaviors; 3 = Severe: Symptoms interfered with activities of daily living or symptoms persisted and required major coping behaviors."|12 weeks after the start of treatment|The FAS, defined as all participants who received at least one dose of study drug and had evaluable post-baseline esophageal biopsy and clinical symptom data.||percentage of participants|||Number
776112|NCT00762177|Primary|Antimicrobial Species in Plaque(Veillonella)|After 14 days of study product use, dental plaque scraped from teeth, placed in sterile phosphate buffered saline(PBS) and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on Veillonella Agar.|14 days|||log CFU (Colony forming units)||Standard Error|Log Mean
776166|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 18)|Feeling of nausea is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 18.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
776100|NCT00762073|Secondary|Percent of Participants With Clinical Response|"Response was defined as a ≥50% reduction from baseline in the eosinophilic esophagitis (EoE) clinical symptom score (CSS). The EoE CSS, scored from 0 to 18 by a doctor, assessed 6 categories: 1) heartburn, 2) abdominal pain, 3) nocturnal awakening with symptoms, 4) nausea, regurgitation, or vomiting, 5) anorexia or early satiety, and 6) dysphagia, odynophagia, or food impaction (a severe symptom). Each domain was scored as follows, based on symptoms in the 2 weeks prior to the assessment:
0 = No symptoms and no coping behaviors required; 1 = Mild: Symptoms limited to 1-3 days or no symptoms because coping behaviors were required to avoid symptoms; 2 = Moderate: Symptoms on >3 days, with or without minor coping behaviors; 3 = Severe: Symptoms interfered with activities of daily living or symptoms persisted and required major coping behaviors."|12 weeks after the start of treatment|The FAS, defined as participants who received at least one dose of study drug and had evaluable post-baseline esophageal biopsy and clinical symptom data.||percentage of participants|||Number
776101|NCT00762073|Secondary|Change From Baseline in Endoscopy Score|Esophageal endoscopy was used to assess the level of inflammation and eosinophilia. Four categories of endoscopic findings were evaluated and scored for this study: (1) pallor and diminished vascular markings; (2) furrowing with thickened mucosa; (3) presence of white mucosal plaques; and (4) concentric rings or strictures. For each category, 0 points were allocated if no esophageal sites were involved, 1 point if 1 or 2 esophageal sites were involved, and 2 points for pan-esophageal involvement (see Aceves et al., 2007). The maximum possible endoscopy score was 8 points. A negative change from baseline indicates that esophageal inflammation decreased.|Baseline, 12 weeks after the start of treatment|The FAS, defined as all participants who received at least one dose of study drug and had evaluable post-baseline esophageal biopsy and clinical symptom data.||scores on a scale||Standard Deviation|Mean
776102|NCT00762073|Secondary|Percent Change From Baseline in Peak Eosinophil Count|The maximum peak number of eosinophils at baseline and at the final treatment evaluation was identified by examining the peak eosinophil counts obtained from the proximal, mid, and distal esophageal biopsies and selecting the maximum value. A negative change from baseline indicates that eosinophil count has decreased.|Baseline, 12 weeks after the start of treatment|The FAS, defined as all participants who received at least one dose of study drug and had evaluable post-baseline esophageal biopsy and clinical symptom data.||percent change||Standard Deviation|Mean
776103|NCT00762073|Secondary|Percent of Participants With Histologic Remission|Histologic remission was defined as a maximum peak eosinophil count at the final treatment evaluation of ≤1 eosinophils/high power field (light microscopy). The maximum peak was identified by examining the peak eosinophil counts obtained from the proximal, mid, and distal esophageal biopsies and selecting the maximum value.|12 weeks after the start of treatment|The FAS, defined as participants who received at least one dose of study drug and had evaluable post-baseline esophageal biopsy and clinical symptom data.||percentage of participants|||Number
776104|NCT00762073|Secondary|Percent of Participants With Histologic Response|Histologic response was defined as a maximum peak eosinophil count at the final treatment evaluation of ≤6 eosinophils/high power field (light microscopy). The maximum peak was identified by examining the peak eosinophil counts obtained from the proximal, mid, and distal esophageal biopsies and selecting the maximum value.|12 weeks after the start of treatment|The FAS, defined as participants who received at least one dose of study drug and had evaluable post-baseline esophageal biopsy and clinical symptom data.||percentage of participants|||Number
776105|NCT00762073|Primary|Percent of Participants Who Responded to Therapy|"Response was defined as a ≥50% reduction from baseline in the eosinophilic esophagitis (EoE) clinical symptom score (CSS) and a reduction in peak eosinophil count to ≤6/high power field (light microscopy) from esophageal biopsies collected at the final evaluation. The EoE CSS, scored from 0 to 18 by a doctor, assessed 6 categories: 1) heartburn, 2) abdominal pain, 3) nocturnal awakening with symptoms, 4) nausea, regurgitation, or vomiting, 5) anorexia or early satiety, and 6) dysphagia, odynophagia, or food impaction (a severe symptom). Each domain was scored as follows, based on symptoms in the 2 weeks prior to the assessment:
0 = No symptoms and no coping behaviors required; 1 = Mild: Symptoms limited to 1-3 days or no symptoms because coping behaviors were required to avoid symptoms; 2 = Moderate: Symptoms on >3 days, with or without minor coping behaviors; 3 = Severe: Symptoms interfered with activities of daily living or symptoms persisted and required major coping behaviors."|12 weeks after the start of treatment|The Full Analysis Set (FAS), defined as participants who received at least one dose of study drug and had evaluable post-baseline esophageal biopsy and clinical symptom data.||percentage of participants|||Number
776106|NCT00762086|Primary|Absolute Claudication Distance (ACD)|Absolute walking distance is measured by walking on a treadmill until the point when the subject is inable to walk anymore due to pain in the leg. The walking distance is measured by meters|3 months|ITT cohort||Meters||Standard Error|Least Squares Mean
776107|NCT00762164|Secondary|Total Cholesterol||6 weeks|||% change in total cholesterol||Standard Deviation|Mean
776108|NCT00762164|Primary|LDL Cholesterol||6 weeks|||% change in LDL cholesterol||Standard Deviation|Mean
776109|NCT00762177|Primary|Antimicrobial Species on the Cheek(Veillonella)|After 14 days of study product use, the inside of the cheek was scraped with a swab and place in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on Veillonella Agar.|14 days|||log CFU (Colony forming units)||Standard Error|Log Mean
776110|NCT00762177|Primary|Antimicrobial Species in Tongue(Veillonella)|After 14 days of study product use, the tongue was scraped 5 times with the edge of a tongue depressor. The sample is vortexed in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on Veillonella Agar.|14 days|||log CFU (Colony forming units)||Standard Error|Log Mean
776111|NCT00762177|Primary|Antimicrobial Species in Saliva(Veillonella)|After 14 days of study product use, saliva was collected by drooling into a tube and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in sterile phosphate buffered saline(PBS) and plated using a spiral systems autoplate 4000 spiral plater on veillonella Agar.|14 days|||log CFU (Colony forming units)||Standard Error|Log Mean
776687|NCT00768560|Secondary|Target Blood Pressure Achievement in Non-elderly (<65)|Non-elderly subjects (<65 years) without diabetes mellitus or chronic renal disorder and target BP SBP <130 mm Hg and DBP <85 mm Hg|After 2 weeks treatment|Subjects valid for efficacy analysis||participants|||Number
776113|NCT00762177|Primary|Antimicrobial Species on the Cheek(Sulfur Bacteria)|After 14 days of study product use, the inside of the cheek was scraped with a swab and place in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on OHO Agar.|14 days|||log CFU (Colony forming units)||Standard Error|Log Mean
776114|NCT00762177|Primary|Antimicrobial Species in Tongue(Sulfur Bacteria)|After 14 days of study product use, the tongue was scraped 5 times with the edge of a tongue depressor. The sample is vortexed in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on OHO Agar.|14 days|||log CFU (Colony forming units)||Standard Error|Log Mean
776115|NCT00762177|Primary|Antimicrobial Species in Saliva(Sulfur Bacteria)|After 14 days of study product use, saliva was collected by drooling into a tube and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in sterile phosphate buffered saline(PBS) and plated using a spiral systems autoplate 4000 spiral plater on OHO Agar.|14 days|||log CFU (Colony forming units)||Standard Error|Log Mean
776116|NCT00762177|Primary|Antimicrobial Species in Plaque(Sulfur Bacteria)|After 14 days of study product use, dental plaque scraped from teeth, placed in sterile phosphate buffered saline(PBS) and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on OHO Agar.|14 days|||log CFU (Colony forming units)||Standard Error|Log Mean
776117|NCT00762177|Primary|Antimicrobial Species on the Cheek(Oral Streptococci)|After 14 days of study product use, the inside of the cheek was scraped with a swab and place in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on Mitis Salivarius Agar|14 days|||log CFU (Colony forming units)||Standard Error|Log Mean
776118|NCT00762177|Primary|Antimicrobial Species in Tongue(Oral Streptococci)|After 14 days of study product use, the tongue was scraped 5 times with the edge of a tongue depressor. The sample is vortexed in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on Mitis Salivarius Agar.|14 days|||log CFU (Colony forming units)||Standard Error|Log Mean
776119|NCT00762177|Primary|Antimicrobial Species in Saliva(Oral Streptococci)|After 14 days of study product use, saliva was collected by drooling into a tube and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in sterile phosphate buffered saline(PBS) and plated using a spiral systems autoplate 4000 spiral plater on Mitis Salivarius Agar.|14 days|||log CFU (Colony forming units)||Standard Error|Log Mean
776120|NCT00762177|Primary|Antimicrobial Species in Plaque(Oral Streptococci)|After 14 days of study product use, dental plaque scraped from teeth, placed in sterile phosphate buffered saline(PBS) and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on Mitis Salivarius Agar.|14 days|||log CFU (Colony forming units)||Standard Error|Log Mean
776121|NCT00762177|Primary|Antimicrobial Species on the Cheek(Fusobacteria)|After 14 days of study product use, the inside of the cheek was scraped with a swab and place in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on CVE Agar.|14 days|||log CFU (Colony forming units)||Standard Error|Log Mean
776122|NCT00762177|Primary|Antimicrobial Species in Tongue(Fusobacteria)|After 14 days of study product use, the tongue was scraped 5 times with the edge of a tongue depressor. The sample is vortexed in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on CVE Agar.|14 days|||log CFU (Colony forming units)||Standard Error|Log Mean
776123|NCT00762177|Primary|Antimicrobial Species in Saliva(Fusobacteria)|After 14 days of study product use, saliva was collected by drooling into a tube and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in sterile phosphate buffered saline(PBS) and plated using a spiral systems autoplate 4000 spiral plater on CVE Agar.|14 days|||log CFU (Colony forming units)||Standard Error|Log Mean
776124|NCT00762177|Primary|Antimicrobial Species in Plaque(Fusobacteria)|After 14 days of study product use, dental plaque scraped from teeth, placed in sterile phosphate buffered saline(PBS) and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on CVE Agar.|14 days|||log CFU (Colony forming units)||Standard Error|Log Mean
776125|NCT00762177|Primary|Antimicrobial Species on the Cheek(Total Anaerobic)|After 14 day of study product use, the inside of the cheek was scraped with a swab and place in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on ETSA Agar.|14 days|||log CFU (Colony forming units)||Standard Error|Log Mean
776126|NCT00762177|Primary|Antimicrobial Species in Tongue(Total Anaerobic)|After 14 days of study product use, the tongue was scraped 5 times with the edge of a tongue depressor. The sample is vortexed in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on ETSA Agar.|14 days|||log CFU (Colony forming units)||Standard Error|Log Mean
776127|NCT00762177|Primary|Antimicrobial Species in Saliva(Total Anaerobic)|After 14 days of study product use, saliva was collected by drooling into a tube and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in sterile phosphate buffered saline(PBS) and plated using a spiral systems autoplate 4000 spiral plater on ETSA Agar|14 days|||log CFU (Colony forming units)||Standard Error|Log Mean
776128|NCT00762177|Primary|Antimicrobial Species in Plaque(Total Anaerobic)|After 14 days of study product use, dental plaque scraped from teeth, placed in sterile phosphate buffered saline(PBS) and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on ETSA Agar|14 days|||log CFU (Colony forming units)||Standard Error|Log Mean
776129|NCT00762177|Primary|Antimicrobial Species on the Cheek(Actinomyces)|After 14 days of study product use, the inside of the cheek was scraped with a swab and place in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on CFAT Agar|14 days|||log CFU (Colony forming units)||Standard Error|Log Mean
776130|NCT00762177|Primary|Antimicrobial Species on the Tongue(Actinomycetes)|After 14 days of study product use, the tongue was scraped 5 times with the edge of a tongue depressor. The sample is vortexed in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on CFAT Agar|14 days|||log CFU (Colony forming units)||Standard Error|Log Mean
776131|NCT00762177|Primary|Antimicrobial Species in Saliva(Actinomyces)|Saliva was collected, after 14 days of product use, by drooling into a tube and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in sterile phosphate buffered saline(PBS) and plated using a spiral systems autoplate 4000 spiral plater on CFAT Agar|14 days|||log CFU (Colony forming units)||Standard Error|Log Mean
776132|NCT00762177|Primary|Antimicrobial Species in Plaque(Actinomyces)|After 14 days of study product use, dental plaque was scraped from the subject's teeth. The plaque was placed in sterile phosphate buffered saline(PBS) and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on CFAT Agar|14 days|||log CFU (Colony forming units)||Standard Error|Log Mean
776133|NCT00762216|Secondary|Residual Refractive Cylinder|The refractive astigmatism 6 months post-surgery, measured in diopters.|6 Months post-surgery|69 eyes (65 patients) were evaluated. Of the original 79 eyes, 10 were excluded from the analysis due to being outside of the protocol specifications.||diopters||Standard Error|Mean
776134|NCT00762216|Primary|Rotational Stability|Average magnitude of intraocular lens (IOL) rotation from day of surgery to 6-months post-surgery, measured in degrees.|6 Months post-surgery|67 eyes (64 patients) were evaluated. Of the original 79 eyes, 10 were excluded from the analysis due to being outside of the protocol specifications. Two (2) additional eyes had no operative intraocular lens (IOL) axis noted on file and were omitted from the analysis of IOL rotation.||degrees||Standard Error|Mean
776135|NCT00762229|Secondary|Total Cholesterol|Total cholesterol fasting|4 weeks|||mg/dL||Standard Deviation|Mean
776136|NCT00762229|Primary|LDL Cholesterol|LDL cholesterol|4 weeks|||mg/dL||Standard Deviation|Mean
776137|NCT00762268|Secondary|YMRS||6-weeks||||||
776138|NCT00762268|Secondary|HAM-D||6-weeks||||||
776139|NCT00762268|Primary|MADRS|Assessment of current mania symptoms using Mania Acute Change Scale (MACS). All 20 questions on the scale have a 0 (absent)-4(most severe) range for describing mania symptoms. The mean MACS score totals were reported, with the total ranging from 0-80. A higher total score indicates a greater number of symptoms and higher symptom intensity, while a smaller score indicates a lesser number of symptoms and lower intensity.|At each weekly visit for 4 weeks|||units on a scale||Full Range|Mean
776140|NCT00762320|Secondary|Parent Satisfaction|Parent Satisfaction Survey. Eight item Likert scale of parent/guardian satisfaction with the child's HIV treatment regimen. Item scores are summed to compute a total score. Total scores are reported with a minimum of 0 and a maximum of 32, with higher scores indicating higher satisfaction.|Baseline, 4 week, 12 weeks and 24 weeks|||Score on a survey||Standard Deviation|Mean
776141|NCT00762320|Primary|Lopinavir and Ritonavir AUC on Low Dose Tablet|Lopinavir and Ritonavir AUC at 4 weeks when participants are receiving the study intervention, low dose tablet formulation of Kaletra. Data collection points for AUC were 0, 2, 4, 6, and 8 hours post dose.|4 weeks|All participants were analyzed||hr*ng/ml||Standard Deviation|Median
776142|NCT00762320|Primary|Lopinavir (Lpv) and Ritonavir (Rtv) Cmax at 4 Weeks|Lpv and rtv Cmax at 4 weeks when participants are receiving study intervention, low dose Kaletra. Time points for data collection: 0, 2hrs, 4hrs, 6hrs, 8hrs|4 weeks|All participants were analyzed||ng/ml||Standard Deviation|Median
776143|NCT00762320|Primary|Viral Load (VL)|Number of participants who maintained their Viral load undetectable (< 20 copies/ml) for the duration of the study|Baseline, Week 4, Week 12 and Week 24|All subjects in study were analyzed||participants|||Number
776144|NCT00762320|Secondary|Symptoms Across All Patients|Cumulative tally of symptoms for each patients across all visits. Targetted symptoms were asked for at each visit and patients and parents were encouraged to report additional symptoms that were experienced. Each patient got a score for the total number of symptoms at each visit. Scores were totalled, but it the same symptoms occurred continuously it was counted as 1 symptom.|Baseline, 1 month, 3 months, 6 months|All participants analyzed||numer of symptoms||Standard Deviation|Mean
776145|NCT00762320|Secondary|Patient Satisfaction|Patient Satisfaction Survey. Eight item Likert scale of patient satisfaction with their HIV treatment regimen for patients 7 years of age and older. Items scores are summed to compute a total score. Total scores are reported with a minimum of 0 and a maximum of 32, with higher scores indicating higher satisfaction.|Baseline, 1 month|Patients had to be able to read and write to complete the patient satisfaction questionnaire, so an arbitrary age of 7 was selected and patients under the age of 7 did not complete the patient satisfaction questionnaire. All 5 of the patients over the age of 5 completed the questionnaire and were analyzed.||units on a scale||Standard Deviation|Mean
776146|NCT00762320|Primary|Lopinavir AUC Ratio of Baseline:Week 4|Ratio of AUC at baseline (liquid)to week 4 (reduced dose tablet). AUC data were collected at 0, 2, 4, 6, and 8 hours post dose.|Baseline, week 4|||ratio||Standard Deviation|Mean
776147|NCT00762320|Primary|Lopinavir and Ritonavir Area Under the Curve (AUC) Liquid Kaletra|Area under the curve values for lopinavir at baseline when participants are taking liquid Kaletra as part of their baseline treatment. Time points for data collection: 0, 2 hrs post, 4 hrs post, 6 hrs post, 8 hrs post.|Baseline|All participants were analyzed||hr*ng/ml||Standard Deviation|Median
776148|NCT00762320|Primary|Lopinavir (Lpv) and Ritonavir (Rtv) Maximumu Plasma Concentration (CMax) Liquid|Cmax values at baseline (participants are taking liquid Kaletra as part of baseline treatment). Time points for data collection: 0, 2hrs post dose, 4 hrs post dose, 8 hrs post dose.|Baseline|All participants were analyzed||ng/ml||Standard Deviation|Median
788087|NCT00855595|Secondary|Percentage of Participants With at Least a 25%, 50%, or 75% Improvement in Facial IL Counts From Baseline to Weeks 2, 4, 6, 8 and 12 (LOCF)||Baseline and Weeks 2, 4, 6, 8 and 12|FAS||Percentage of participants|||Number
776149|NCT00762320|Primary|Absolute CD4 and CD4 %|Number of participants who had no clinically significant deterioration in absolute CD4 and % CD4 count for the duration of the study. Absolute CD4 and Percent CD4 counts were determined by single or dual platform analysis performed on blood samples by Phoenix Children's Hospital Laboratory, Sonora Quest Laboratory or Labcorp Laboratory. Clinically significant change was determine to be a deterioration in both Absolute CD4 to less than 500 and %CD4 to less than 25%.|Baseline, 4 weeks, 12 weeks, 26 weeks|All participants were analyzed.||participants|||Number
776150|NCT00762359|Secondary|Number of Participants With Adverse Events|Treatment-emergent adverse events (TEAE) are adverse events with an onset that occurs after receiving study drug. A TEAE may also be a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing. Please see Other Adverse Events table below for TEAE listings.|18 Months|||participants|||Number
776151|NCT00762359|Secondary|Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 18)|Severity of hematemesis and melena (blood stool, black stool, tarry stool) is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 18.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
776152|NCT00762359|Secondary|Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 12)|Severity of hematemesis and melena (blood stool, black stool, tarry stool) is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 12.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
776153|NCT00762359|Secondary|Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 9)|Severity of hematemesis and melena (blood stool, black stool, tarry stool) is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 9.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
776154|NCT00762359|Secondary|Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 6)|Severity of hematemesis and melena (blood stool, black stool, tarry stool) is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 6.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
776155|NCT00762359|Secondary|Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 3)|Severity of hematemesis and melena (blood stool, black stool, tarry stool) is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 3.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
776156|NCT00762359|Secondary|Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 18)|Severity of anorexia is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 18.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
776157|NCT00762359|Secondary|Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 12)|Severity of anorexia is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 12.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
776158|NCT00762359|Secondary|Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 9)|Severity of anorexia is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 9.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
776159|NCT00762359|Secondary|Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 6)|Severity of anorexia is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 6.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
776160|NCT00762359|Secondary|Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 3)|Severity of anorexia is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 3.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
776161|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 18)|Feeling of heartburn is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 18.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
776162|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 12)|Feeling of heartburn is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 12.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
776163|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 9)|Feeling of heartburn is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 9.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
776164|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 6)|Feeling of heartburn is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 6.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
776165|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 3)|Feeling of heartburn is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 3.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
776688|NCT00768560|Secondary|Target Blood Pressure Achievement in Elderly (≥65)|Elderly subjects (≥65 years) without diabetes mellitus or chronic renal disorders and target BP SBP <140 mm Hg and DBP <90 mm Hg|After 2 weeks treatment|Subjects valid for efficacy analysis||participants|||Number
776169|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 6)|Feeling of nausea is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 6.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
776170|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 3)|Feeling of nausea is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 3.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
776171|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 18)|Feeling of enlarged abdomen is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 18.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
776172|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 12)|Feeling of enlarged abdomen is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 12.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
776173|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 9)|Feeling of enlarged abdomen is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 9.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
776174|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 6)|Feeling of enlarged abdomen is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 6.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
776175|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 3)|Feeling of enlarged abdomen is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 3.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
776176|NCT00762359|Secondary|Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 18)|Hunger and nighttime pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 18.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
776177|NCT00762359|Secondary|Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 12)|Hunger and nighttime pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 12.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
776178|NCT00762359|Secondary|Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 9)|Hunger and nighttime pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 9.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
776179|NCT00762359|Secondary|Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 6)|Hunger and nighttime pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 6.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
776180|NCT00762359|Secondary|Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 3)|Hunger and nighttime pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 3.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
776181|NCT00762359|Secondary|Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 18)|Postprandial pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 18.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
776182|NCT00762359|Secondary|Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 12)|Postprandial pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 12.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
776183|NCT00762359|Secondary|Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 9)|Postprandial pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 9.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
776184|NCT00762359|Secondary|Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 6)|Postprandial pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 6.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
776185|NCT00762359|Secondary|Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 3)|Postprandial pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 3.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
776186|NCT00762359|Secondary|Number of Participants With Gastric or Duodenal Ulcer or Gastric or Duodenal Hemorrhagic Lesion (Upper Gastrointestinal Hemorrhage)|Number of participants with gastric or duodenal ulcer or gastric or duodenal hemorrhagic lesion (upper gastrointestinal hemorrhage) from baseline through month 18 or final visit. Ulcers are defined as mucosal defect with white coating 3 mm or greater.|18 Months|Values are from the Full Analysis Set.||participants|||Number
791686|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Lymphocytes)||Baseline up to Month 7|||percentage of participants|||Number
776187|NCT00762359|Secondary|Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 18)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.|Baseline and Month 18.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
776188|NCT00762359|Secondary|Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.|Baseline and Month 12.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
776189|NCT00762359|Secondary|Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 9)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.|Baseline and Month 9.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
776190|NCT00762359|Secondary|Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.|Baseline and Month 6.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
776191|NCT00762359|Secondary|Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.|Baseline and Month 3.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
776192|NCT00762359|Secondary|Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 18)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.|Baseline and Month 18.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
776193|NCT00762359|Secondary|Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.|Baseline and Month 12.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
776194|NCT00762359|Secondary|Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 9)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.|Baseline and Month 9.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
776195|NCT00762359|Secondary|Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.|Baseline and Month 6.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Median
776196|NCT00762359|Secondary|Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.|Baseline and Month 3.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
776197|NCT00762359|Primary|Number of Participants With Gastric Ulcer and/or Duodenal Ulcer|The number of participants that developed gastric ulcer and/or duodenal ulcer at month 18 or final visit. Ulcers are defined as mucosal defect with white coating 3 mm or greater.|18 Months|Participants not taking investigational drug were not included.||participants|||Number
776198|NCT00762385|Primary|Comfort Symptoms|A weighted combined score calculated from individual comfort-related questions was used to derive comfort outcomes. >0 = comfortable, <0 = uncomfortable|1-week, 2-weeks|Only participants who completed the study per protocol (n=78)||score||Standard Error|Least Squares Mean
776199|NCT00762385|Secondary|Overall Corneal Staining|Measured for 5 zones of the cornea (superior, nasal, central, inferior, temporal)on a 0 to 3 grade scale (NEI 0-3 scale). Grade 0 = Normal/ grade 1 = mild, superficial stippling/ grade 2 = moderate, punctate staining including superficial abrasion of the cornea/ grade 3 = severe, abrasion or corneal erosion, deep corneal abrasion or recurrent erosion.|2 weeks|Only the participants who completed the study per protocol (n=78)||combined score||Standard Error|Least Squares Mean
776200|NCT00762385|Primary|Lens Comfort|>0 = comfortable, <0 = uncomfortable; a weighted combined score calculated from individual comfort-related questions was used to derive comfort outcomes.|1-week, 2- weeks|Only participants who completed the study per protocol (n=78)||combined score||Standard Error|Least Squares Mean
776201|NCT00762411|Secondary|Change From Baseline in Alzheimer's Disease Assessment Scale (ADAS-Cog14) at 16 Weeks After Cessation of Study Drug|ADAS-Cog14 is ADAS-Cog11 augmented with delayed free recall, digit cancellation, and maze completion measures. A score of 0 to 10 for delayed free recall and a conversion code of 0 to 5 for digit cancellation and maze completion provide total score ranges for this extended ADAS-Cog14 of 0 to 90. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, concomitant standard of care (SOC) medication.|Baseline (randomization), 16 weeks following treatment cessation|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication and had both baseline and post-baseline evaluable data.||units on a scale||Standard Error|Least Squares Mean
776202|NCT00762411|Secondary|Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog12) at 16 Weeks After Cessation of Study Drug|ADAS-Cog12 is ADAS‑Cog11 augmented with delayed free recall measure, resulting in a total score ranging from 0 to 80. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 16 weeks following treatment cessation|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication and had both baseline and post-baseline evaluable data.||units on a scale||Standard Error|Least Squares Mean
776203|NCT00762411|Secondary|Change From Baseline in Amyloid Beta (Aβ) 1-42 Concentration in Spinal Fluid up to 76 Weeks|Concentration of an amino acid peptide known as Aβ 1-42 in spinal fluid. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.|Baseline (randomization), up to 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication, last observation carried forward (LOCF).||picogram per milliliter (pg/mL)||Standard Error|Least Squares Mean
776204|NCT00762411|Secondary|Change From Baseline in Phosphorylated-Tau (P-tau) Concentration in Spinal Fluid up to 76 Weeks|Concentration of p-tau in spinal fluid. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.|Baseline (randomization), up to 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication, last observation carried forward (LOCF).||picogram per milliliter (pg/mL)||Standard Error|Least Squares Mean
776205|NCT00762411|Secondary|Change From Baseline in Alzheimer's Disease Assessment Scale (ADAS-Cog14) at 76 Weeks|ADAS-Cog14 is ADAS-Cog11 augmented with delayed free recall, digit cancellation, and maze completion measures. A score of 0 to 10 for delayed free recall and a conversion code of 0 to 5 for digit cancellation and maze completion provide total score ranges for this extended ADAS-Cog14 of 0 to 90. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication.||units on a scale||Standard Error|Least Squares Mean
776206|NCT00762411|Secondary|Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog12) at 76 Weeks|ADAS-Cog12 is ADAS‑Cog11 augmented with delayed free recall measure, resulting in a total score ranging from 0 to 80. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication and had both baseline and post-baseline evaluable data.||units on a scale||Standard Error|Least Squares Mean
776207|NCT00762411|Secondary|Change From Baseline in Mini Mental State Examination (MMSE) 4 Weeks After Cessation of Study Drug|Used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, and copy figures) in elderly participants. Total score ranges: 0 to 30. Lower score indicates greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication. All LY450139 dosing was stopped due to evidence of dose-dependent cognitive/functional worsening. Participants were followed off-dose for 32 weeks, but MMSE was not assessed.|Baseline (randomization), 4 weeks following treatment cessation|August 2010: all dosing was stopped after protocol-specified interim review showed dose-dependent cognitive/functional worsening of LY450139-treated participants. Participants were followed off-dose for 32 weeks. No analysis was performed at 4 weeks after cessation of drug since this outcome measure was not assessed during the follow-up period.|||||
776216|NCT00762411|Secondary|Change From Baseline in Amyloid Imaging Positron Emission Tomography (AV-45 PET) up to 76 Weeks|A radioactive tracer for PET that is a ligand for amyloid called [18F]-AV-45. This permits the visualization of amyloid in the brains of Alzheimer’s participants. The outcome reported is the composite summary of the standard uptake value ratio (SUVR) normalized to the cerebellar gray matter. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.|Baseline (randomization), up to 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication, last observation carried forward (LOCF).||ratio||Standard Error|Least Squares Mean
776208|NCT00762411|Secondary|Change From Baseline in Quality of Life in Alzheimer's Disease (QoL-AD) at 4 Weeks After Cessation of Study Drug|Assess QoL for AD; participant rates mood, relationships, memory, finances, physical condition, and overall QoL assessment. Each of 13 items rated on a 4-point scale. Sum of items=total score (range: 13-52). Higher scores=greater QoL. Participant's primary caregiver asked to complete same measure. Least Squares Mean value controlled for baseline, age, investigator, visit, and concomitant standard of care (SOC) medication. All LY450139 dosing was stopped due to evidence of dose-dependent cognitive/functional worsening. Participants were followed off-dose for 32 weeks, but QoL-AD not assessed.|Baseline (randomization), 4 weeks following treatment cessation|August 2010: all dosing was stopped after protocol-specified interim review showed dose-dependent cognitive/functional worsening of LY450139-treated participants. Participants were followed off-dose for 32 weeks. No analysis was performed at 4 weeks after cessation of drug since this outcome measure was not assessed during the follow-up period.|||||
776209|NCT00762411|Secondary|Change From Baseline in EuroQol 5-Dimensional Health-Related Quality of Life Scale Proxy Version (EQ-5D Proxy) Visual Analog Scale (VAS) at 4 Weeks After Cessation of Study Drug|EQ-5D (proxy version) measures mobility, self-care, usual activities, pain/discomfort, anxiety/depression. 3 severity levels: no, some, severe problems. VAS assesses caregiver's impression of participant's health state; score ranges: 0 to 100. Lower scores=greater disease severity. Least Squares (LS) Mean value controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication. All LY450139 dosing was stopped due to evidence of dose-dependent cognitive/functional worsening. Participants were followed off-dose for 32 weeks, but EQ-5D VAS was not assessed.|Baseline (randomization), 4 weeks following treatment cessation|August 2010: all dosing was stopped after protocol-specified interim review showed dose-dependent cognitive/functional worsening of LY450139-treated participants. Participants were followed off-dose for 32 weeks. No analysis was performed at 4 weeks after cessation of drug since this outcome measure was not assessed during the follow-up period.|||||
776210|NCT00762411|Secondary|Change From Baseline in Resource Utilization in Dementia-Lite (RUD-Lite) at 4 Weeks After Cessation of Study Drug|Assesses healthcare resource utilization (formal and informal care). Information gathered on both care-giving time, work status) and participants (accommodation, healthcare resource utilization) is collected. Reported number of participant hospitalizations. Least Squares (LS) Mean value controlled for age and investigator. All LY450139 dosing was stopped due to evidence of dose-dependent cognitive/functional worsening. Participants were followed off-dose for 32 weeks, but RUD-Lite was not assessed.|Baseline (randomization), 4 weeks following treatment cessation|August 2010: all dosing was stopped after protocol-specified interim review showed dose-dependent cognitive/functional worsening of LY450139-treated participants. Participants were followed off-dose for 32 weeks. No analysis was performed at 4 weeks after cessation of drug since this outcome measure was not assessed during the follow-up period.|||||
776211|NCT00762411|Secondary|Change From Baseline in Neuropsychiatric Inventory (NPI) at 4 Weeks After Cessation of Study Drug|NPI assesses psychopathology in participants with dementia and other neurologic disorders. Information is obtained from a caregiver familiar with participant's behavior. Total score ranges from 12 to 144; higher scores indicate greater disease severity. The Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication. All LY450139 dosing stopped due to evidence of dose-dependent cognitive/functional worsening. Participants were followed off-dose for 32 weeks, but NPI was not assessed.|Baseline (randomization), 4 weeks following treatment cessation|August 2010: all dosing was stopped after protocol-specified interim review showed dose-dependent cognitive/functional worsening of LY450139-treated participants. Participants were followed off-dose for 32 weeks. No analysis was performed at 4 weeks after cessation of drug since this outcome measure was not assessed during the follow-up period.|||||
776212|NCT00762411|Secondary|Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) at 4 Weeks After Cessation of Study Drug|Semi-structured interview. Participant's cognitive status rated across 6 domains of functioning: memory, orientation, judgment/problem solving, community affairs, home/hobbies, personal care. Severity score assigned for each of 6 domains; total score (SB) ranges: 0 to 18. Higher scores=greater disease severity. Least Squares Mean value controlled for baseline value, age, investigator, visit, and concomitant standard of care medication. LY450139 dosing stopped due to evidence of dose-dependent cognitive/functional worsening. Participants followed off-dose for 32 weeks, but CDR-SB not assessed.|Baseline (randomization), 4 weeks following treatment cessation|August 2010: all dosing was stopped after protocol-specified interim review showed dose-dependent cognitive/functional worsening of LY450139-treated participants. Participants were followed off-dose for 32 weeks. No analysis was performed at 4 weeks after cessation of drug since this outcome measure was not assessed during the follow-up period.|||||
776213|NCT00762411|Secondary|LY450139 Population Pharmacokinetics: Volume of Distribution of LY450139|Model-estimated apparent volume of distribution. Volume of distribution is a measure of the extent to which drug distributes in the body.|6 weeks, 12 weeks, and 52 weeks|All participants randomized to LY450139 with sufficient dosing information and concentration data to allow estimation of pharmacokinetic parameters.||liters (L)||Geometric Coefficient of Variation|Geometric Mean
776214|NCT00762411|Secondary|LY450139 Population Pharmacokinetics: Clearance of LY450139|Model estimated apparent oral clearance. Clearance is defined as the volume of plasma which is completely cleared of drug (LY450139) per unit time.|6 weeks, 12 weeks, and 52 weeks|All participants randomized to LY450139 with sufficient dosing information and concentration data to allow estimation of pharmacokinetic parameters.||liters per hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
776215|NCT00762411|Secondary|Change From Baseline in Tau Concentration in Spinal Fluid up to 76 Weeks|Concentration of total tau in spinal fluid. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.|Baseline (randomization), up to 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication, last observation carried forward (LOCF).||picogram per milliliter (pg/mL)||Standard Error|Least Squares Mean
776217|NCT00762411|Secondary|Change From Baseline in Hippocampal Volume Using Volumetric Magnetic Resonance Imaging (vMRI) up to 76 Weeks|The vMRI assessment of right and left hippocampal volume is reported. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.|Baseline (randomization), up to 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication, last observation carried forward (LOCF).||cubic millimeter (mm^3)||Standard Error|Least Squares Mean
776218|NCT00762411|Secondary|Change From Baseline in Positron Emission Tomography (PET) Using Fluorine-18 Fluorodeoxyglucose (18F-FDG) at 76 Weeks|Measurement of local cerebral glucose metabolism by PET using the radioactive tracer 18F-FDG. The outcome reported is the composite summary of the standard uptake value ratio (SUVR) normalized to the Pons. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.|Baseline (randomization), 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication and had both baseline and post-baseline evaluable data.||ratio||Standard Error|Least Squares Mean
776219|NCT00762411|Secondary|Percent Change From Baseline in Amyloid Beta (Aβ) 1-42 Plasma Concentration at 52 Weeks|Concentration of amino acid peptide known as Aβ 1-42 in plasma. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.|Baseline (randomization), 52 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication.||picogram per milliliter (pg/mL)||Standard Error|Least Squares Mean
776220|NCT00762411|Secondary|Change From Baseline in Mini Mental State Examination (MMSE) at 76 Weeks|MMSE is a brief screening instrument used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, and copy figures) in elderly participants. Total score ranges from 0 to 30; lower score indicates greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication|Baseline (randomization), 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication.||units on a scale||Standard Error|Least Squares Mean
776221|NCT00762411|Secondary|Change From Baseline in Quality of Life in Alzheimer's Disease (QoL-AD) at 76 Weeks|Assess QoL for AD: participant rates mood, relationships, memory, finances, physical condition, and overall QoL assessment. Each of 13 items, rated on a 4-point scale. Sum of items=total score (range: 13 to 52). Higher scores indicate greater QoL. Participant’s primary caregiver asked to complete same measure. Least Squares (LS) Mean value controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication.||units on a scale||Standard Error|Least Squares Mean
776222|NCT00762411|Secondary|Change From Baseline in the EuroQol 5-Dimensional Health-Related Quality of Life Scale Proxy Version (EQ-5D Proxy) Visual Analog Scale (VAS) at 76 Weeks|EQ-5D (proxy version) measures mobility, self-care, usual activities, pain/discomfort, anxiety/depression; each has 3 severity levels (no, some, severe problems) coded to a 1-digit number (1-3). Digits are combined into 5-digit number describing health state. Numerals 1-3 are not added for total score. VAS assesses caregiver's impression of participant's overall health state; scores range: 0 to 100. Lower scores indicate greater disease severity. Least Squares (LS) Mean value controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication.||units on a scale||Standard Error|Least Squares Mean
776223|NCT00762411|Secondary|Change From Baseline in the Resource Utilization in Dementia-Lite (RUD-Lite) up to 76 Weeks|Assesses healthcare resource utilization (formal and informal care). Information gathered on both caregivers (care-giving time, work status) and participants (accommodation and healthcare resource utilization) was gathered from baseline and follow-up interviews. Reported number of hospitalizations per participant up to 76 weeks. Least Squares (LS) Mean value was controlled for age and investigator.|Baseline (randomization), up to 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication, last observation carried forward (LOCF).||number of hospitalizations||Standard Error|Least Squares Mean
776224|NCT00762411|Secondary|Change From Baseline in Neuropsychiatric Inventory (NPI) at 76 Weeks|NPI assesses psychopathology in participants with dementia and other neurologic disorders. Information is obtained from a caregiver familiar with the participant’s behavior. Total score ranges from 12 to 144; higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication.||units on a scale||Standard Error|Least Squares Mean
776225|NCT00762411|Secondary|Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) at 76 Weeks|CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication and had both baseline and post-baseline evaluable data.||units on a scale||Standard Error|Least Squares Mean
776226|NCT00762411|Primary|Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) at 16 Weeks After Cessation of Study Drug|The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant’s caregiver. The ADCS-ADL measures both basic and instrumental activities of daily living by participants. The total score ranges from 0 to 78, with lower scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 16 weeks following treatment cessation|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication and had both baseline and post-baseline evaluable data.||units on a scale||Standard Error|Least Squares Mean
776227|NCT00762411|Primary|Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) at 76 Weeks|The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant’s caregiver. The ADCS-ADL measures both basic and instrumental activities of daily living by participants. The total score ranges from 0 to 78, with lower scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication.||units on a scale||Standard Error|Least Squares Mean
776228|NCT00762411|Primary|Change From Baseline in Alzheimer's Disease Assessment Scale- Cognitive Subscale (ADAS-Cog11) at 16 Weeks After Cessation of Study Drug|The cognitive subscale of ADAS (ADAS Cog11) consists of 11 items assessing areas of function most typically impaired in Alzheimer’s disease (AD): orientation, verbal memory, language, and praxis. The scale ranges from 0 to 70, with higher scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 16 weeks following treatment cessation|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication and had both baseline and post-baseline evaluable data.||units on a scale||Standard Error|Least Squares Mean
776229|NCT00762411|Primary|Change From Baseline in Alzheimer's Disease Assessment Scale- Cognitive Subscale (ADAS-Cog11) at 76 Weeks|The cognitive subscale of the ADAS (ADAS Cog11) was used as a primary efficacy measure and consists of 11 items assessing areas of function most typically impaired in Alzheimer’s disease (AD): orientation, verbal memory, language, and praxis. The scale ranges from 0 to 70, with higher scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication.||units on a scale||Standard Error|Least Squares Mean
776230|NCT00762424|Primary|Time of Stone Passage|Upon discharge, patient must be able to take the medication for 10 days and strain his/her urine. Patient must log the date and time of stone passage, if known.|10 Days|||hours||Inter-Quartile Range|Median
776231|NCT00762450|Primary|ph of Dental Plaque After Sucrose Challenge|Panelists rinsed with toothpaste slurry (2 grams of toothpaste dissolved in 10 ml of water) waited 20 minutes and then rinsed with a 10% sucrose solution. Sucrose challenge is used to change the ph in the mouth and help determine if the toothpastes used in this study and control dental plaque growth.|1 week|||ph of dental plaque||Standard Deviation|Mean
776232|NCT00762463|Secondary|Paracetamol Tablets Taken Per Day by Participant|Calculated as the total number of paracetamol tablets taken divided by days of exposure in the study.|Week 6|FAS||tablets per day||Standard Deviation|Mean
776233|NCT00762463|Secondary|Percentage of Days With Concomitant Administration of Paracetamol|Calculated as days on rescue medication divided by days of exposure in the study at the end of Week 6.|Week 6|FAS||percentage of days||Standard Deviation|Mean
776234|NCT00762463|Secondary|Percentage of Participants With Concomitant Use of Paracetamol|Percentage of participants who concomitantly took at least 1 paracetamol tablet as rescue medication at Week 6|Week 6|FAS||percentage of participants|||Number
776235|NCT00762463|Secondary|Change From Baseline in CRP at Week 12|CRP was a marker of inflammation. Lower values indicated better health. Change from baseline <0 indicated improvement.|Baseline, Week 12|FAS. n = evaluable participants at that time point.||mg/L||Standard Deviation|Mean
776236|NCT00762463|Secondary|Change From Baseline in C-Reactive Protein (CRP) at Week 6|C-Reactive Protein (CRP) was a marker of inflammation, measured in milligram per liter (mg/L). Change from baseline <0 indicated improvement.|Baseline, 6 Weeks|FAS||mg/L||Standard Error|Least Squares Mean
776237|NCT00762463|Secondary|Change From Baseline in ESR at Week 12|ESR was a laboratory test that provided a non-specific measure of inflammation. The test assessed the rate at which red blood cells fell in a test tube. Lower values indicated better health. Change from baseline <0 indicated improvement.|Baseline, Week 12|FAS. n = evaluable participants at that time point.||mm/h||Standard Deviation|Mean
776238|NCT00762463|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 6|Erythrocyte Sedimentation Rate (ESR) was a laboratory test that providee a non-specific measure of inflammation. The test assessed the rate at which red blood cells fell in a test tube and was measured in millimeter per hour (mm/h). Change from baseline <0 indicated improvement.|Baseline, Week 6|FAS||mm/h||Standard Error|Least Squares Mean
776239|NCT00762463|Secondary|Change From Baseline in Chest Expansion at Week 12|Chest expansion, measured in cm, is defined as the difference in thoracic circumference during full expiration versus full inspiration, measured at the fourth intercostal space (nipple line). The better of 2 tries was recorded. Higher scores indicate better health. Change from baseline greater than (>) 0 represented improvement.|Baseline, Week 12|FAS. n = evaluable participants at that time point.||cm||Standard Deviation|Mean
776240|NCT00762463|Secondary|Change From Baseline in Chest Expansion at Weeks 2, 4, and 6|Chest expansion, measured in cm, is defined as the difference in thoracic circumference during full expiration versus full inspiration, measured at the fourth intercostal space (nipple line). The better of 2 tries was recorded. Change from baseline greater than (>) 0 represented improvement.|Baseline, Weeks 2, 4, 6|FAS. N = total evaluable participants. n = evaluable participants at that time point.||cm||Standard Error|Least Squares Mean
776241|NCT00762463|Secondary|Change From Baseline in Fingertips to Floor Distance at Week 12|Fingertips to floor distance measured in cm from the tip of the fingers to the floor with participant standing erect and feet together, knees as straight as possible, then bending forward as far as possible with fingers reaching towards the floor. The better of 2 tries was recorded. Lower scores indicated better health. Change from baseline <0 represented improvement.|Baseline, Week 12|FAS. n = evaluable participants at that time point.||cm||Standard Deviation|Mean
776242|NCT00762463|Secondary|Change From Baseline in Fingertips to Floor Distance at Weeks 2, 4, and 6|Fingertips to floor distance measured in centimeter (cm) from the tip of the fingers to the floor with participants standing erect and feet together, knees as straight as possible, then bending forward as far as possible with fingers reaching towards the floor. The better of 2 tries was recorded. Change from baseline <0 indicated improvement.|Baseline, Weeks 2, 4, 6|FAS. N = total evaluable participants. n = evaluable participants at that time point.||cm||Standard Error|Least Squares Mean
776243|NCT00762463|Secondary|Change From Baseline in Nocturnal Pain at Week 12|"100-mm VAS scores specified participant's nocturnal pain in response to the following question Did you have any pain in the neck, back or hips during the previous night? 0=no pain to 100=worst pain possible. Lower scores indicated less pain. Change from baseline <0 indicated improvement."|Baseline, Week 12|FAS. n = evaluable participants at that time point.||mm||Standard Deviation|Mean
776258|NCT00762476|Secondary|Rhinovirus-associated Colds|The incidence of rhinovirus-associated cold illnesses.|10 weeks|All efficacy analyses were performed on the intent-to-treat (ITT).The ITT population included all enrolled subjects who received study treatment.||RV-associated cold illnesses per 100 sub|||Number
776244|NCT00762463|Secondary|Change From Baseline in Nocturnal Pain at Weeks 2, 4, and 6|"100-mm VAS scores specified participant's nocturnal pain in response to the following question Did you have any pain in the neck, back or hips during the previous night? 0=no pain to 100=worst pain possible. Change from baseline <0 indicated improvement."|Baseline, Weeks 2, 4, 6|FAS. N = total evaluable participants. n = evaluable participants at that time point.||mm||Standard Error|Least Squares Mean
776245|NCT00762463|Secondary|Percentages of Participants Responding to Assessment in Ankylosing Spondylitis (ASAS)-20|Percentages of participants who demonstrated an improvement of greater than or equal to (≥) 20% from baseline and an absolute improvement of ≥10 mm from baseline on a 100-mm VAS in ≥3 of the 4 domains proposed by the Ankylosing Spondylitis Assessment Working Group (ASAS-20).|Weeks 2, 4, 6, 12|FAS. N = total evaluable participants. n = evaluable participants at that time point.||percentage of participants|||Number
776246|NCT00762463|Secondary|Change From Baseline in BASDAI at Week 12|BASDAI is comprised of 6 specific questions, each answered on a 10-mm VAS. Scores for the first 5 questions: 0=none to 10=severe. Score for the sixth question: 0=0 hours to 10=2 hours. BASDAI score was defined as the mean of the scaled responses to these 6 questions. Lower scores indicated better health. Change from baseline <0 indicated improvement.|Baseline, Week 12|FAS. n = evaluable participants at that time point.||mm||Standard Deviation|Mean
776247|NCT00762463|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Weeks 2, 4, and 6|Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) was comprised of 6 specific questions, each answered on a 10-mm VAS scale. Scores for the first 5 questions: 0=none to 10=severe. Score for the sixth question: 0=0 hours to 10=2 hours. BASDAI score was defined as the mean of the scaled responses to these 6 questions. Change from baseline <0 indicated improvement.|Baseline, Weeks 2, 4, 6|FAS. N = total evaluable participants. n = evaluable participants at that time point.||mm||Standard Error|Least Squares Mean
776248|NCT00762463|Secondary|Change From Baseline in BASFI at Week 12|BASFI was comprised of 10 specific questions, each answered on a 10-mm VAS scale. 0=easy to 10=impossible. BASFI score was defined as the mean of the scaled responses to these 10 questions. Lower scores indicated better functional health. Change from baseline <0 indicated improvement.|Baseline, Week 12|FAS. n = evaluable participants at that time point.||mm||Standard Deviation|Mean
776249|NCT00762463|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, and 6|Bath Ankylosing Spondylitis Functional Index (BASFI) was comprised of 10 specific questions, each answered on a 10-mm VAS scale. 0=easy to 10=impossible. BASFI score was defined as the mean of the scaled responses to these 10 questions. Change from baseline <0 indicated improvement.|Baseline, Weeks 2, 4, 6|FAS. N = total evaluable participants. n = evaluable participants at that time point.||mm||Standard Error|Least Squares Mean
776250|NCT00762463|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity at Week 12|5-point Likert scale scores specified physician's subjective assessment on how the overall ankylosing spondylitis appeared at the time of the participant's visit and participant's disease signs. 1=very good to 5=very poor. Lower scores indicated better health. Change from baseline <0 indicated improvement.|Baseline, Week 12|FAS. n = evaluable participants at that time point.||units on a scale||Standard Deviation|Mean
776251|NCT00762463|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity at Weeks 2, 4, and 6|5-point Likert scale scores specified physician's subjective assessment on how overall ankylosing spondylitis appeared at the time of participant's visit and participant's disease signs. 1=very good to 5=very poor. Change from baseline <0 indicated improvement.|Baseline, Weeks 2, 4, 6|FAS. N = total evaluable participants. n = evaluable participants at that time point.||units on a scale||Standard Error|Least Squares Mean
776252|NCT00762463|Secondary|Change From Baseline in Participant's Global Assessment of Disease Activity at Week 12|"5-point Likert scale scores specified participant's current situation in response to the following question Considering all the ways your Ankylosing Spondylitis affects you, how are you doing today? 1=very good to 5=very poor. Lower scores indicated better health. Change from baseline <0 indicated improvement."|Baseline, Week 12|FAS. n = evaluable participants at that time point.||units on a scale||Standard Deviation|Mean
776253|NCT00762463|Secondary|Change From Baseline in Participant's Global Assessment of Disease Activity at Weeks 2, 4, and 6|"5-point Likert scale scores specified participant's current situation in response to the following question Considering all the ways your Ankylosing Spondylitis affects you, how are you doing today? 1=very good to 5=very poor. Change from baseline <0 indicated improvement."|Baseline, Weeks 2, 4, 6|FAS. N = total evaluable participants. n = evaluable participants at that time point.||units on a scale||Standard Error|Least Squares Mean
776254|NCT00762463|Secondary|Change From Baseline in Participant's Assessment of Global Pain Intensity at Week 12|"100-mm VAS score specified participant's assessment of overall pain intensity in the previous 48 hours, in response to the following question What has been your global pain intensity in the last 48 hours? 0=no pain to 100=worst pain. Lower scores indicated less pain. Change from baseline of <0 indicated improvement."|Baseline, Week 12|FAS. n = evaluable participants at that time point.||mm||Standard Deviation|Mean
776255|NCT00762463|Secondary|Change From Baseline in Participant's Assessment of Global Pain Intensity at Weeks 2 and 4|"100-mm VAS score specified participant's assessment of overall pain intensity in the previous 48 hours, in response to the following question What has been your global pain intensity in the last 48 hours? 0=no pain to 100=worst pain. Change from baseline of <0 indicated improvement."|Baseline, Weeks 2, 4|Full Analysis Set (FAS). Number of participants analyzed (N) = total evaluable participants. n = evaluable participants at that time point.||mm||Standard Error|Least Squares Mean
776256|NCT00762463|Primary|Participant's Assessment of Global Pain Intensity at Baseline|"100-mm VAS scores specified participant's assessment of global pain intensity in the previous 48 hours, in response to the following question What has been your global pain intensity in the last 48 hours? 0=no pain to 100=worst pain. Lower scores indicated less pain."|Baseline|PP||mm||Standard Deviation|Mean
776257|NCT00762463|Primary|Change From Baseline in Participant's Assessment of Global Pain Intensity at Week 6|"100-millimeter (mm) Visual Analog Scale (VAS) score specified participant's assessment of overall pain intensity in the previous 48 hours, in response to the following question What has been your global pain intensity in the last 48 hours? 0=no pain to 100=worst pain. Change from baseline of less than (<) 0 indicated improvement."|Baseline, Week 6|Per-Protocol (PP): All randomized participants who received at least one dose of study medication, and had global pain intensity assessment at Week 6 and no major protocol deviations.||mm||Standard Error|Least Squares Mean
776260|NCT00762476|Primary|The Primary Efficacy Endpoint of This Study is the Incidence of Cold Illnesses.|Comparison of the total number of incidence of cold illnesses over the course of the study per 100 subjects in each treatment group|10 weeks|All efficacy analyses were performed on the intent-to-treat (ITT).The ITT population included all enrolled subjects who received study treatment.||cold illnesses per 100 subjects|||Number
776261|NCT00762502|Primary|Tarsal Roughness|Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.|at 3 months of lens wear (period 1)|Subjects analyzed included those who were enrolled, randomized to a study arm, and completed the study at 3 months, (n=77). Subjects were analyzed by device therefore the subjects from the contralateral arm were counted once in EITHER of the device arms for analysis.||units on a scale|Participants|Standard Deviation|Mean
776262|NCT00762502|Primary|Bulbar Redness|Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.|at 3 months of lens wear (period 1)|Subjects analyzed included those who were enrolled, randomized to a study arm, and completed the study at 3 months, (n=77). Subjects were analyzed by device therefore the subjects from the contralateral arm were counted once in EITHER of the device arms for analysis.||units on a scale|Participants|Standard Deviation|Mean
776263|NCT00762502|Primary|Limbal Redness|Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.|at 3 months of lens wear (period 1)|Subjects analyzed included those who were enrolled, randomized to a study arm, and completed the study at 3 months, (n=77). Subjects were analyzed by device therefore the subjects from the contralateral arm were counted once in EITHER of the device arms for analysis.||units on a scale|Participants|Standard Deviation|Mean
776264|NCT00762502|Primary|Corneal Staining|Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.|at 3 months of lens wear (period 1)|Subjects analyzed included those who were enrolled, randomized to a study arm, and completed the study at 3 months, (n=77). Subjects were analyzed by device therefore the subjects from the contralateral arm were counted once in EITHER of the device arms for analysis.||units on a scale|Participants|Standard Deviation|Mean
776265|NCT00762515|Secondary|Control Gingivitis in Adults|Gingivitis Index (GI) is described as Units on a scale 0 to 3 (0 = no inflammation,1 = Mild inflammation - slight change in color and little change in texture 2 = Moderate inflammation - moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding. GI score = Sum of all scores divided by the number of sites (teeth scored).|6 weeks|||Units on a scale||Standard Deviation|Mean
776266|NCT00762515|Primary|Control Established Plaque in Adults|Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth. Total Plaque score=sum of all scores divided by the number of sites (teeth) scored.|6 weeks|||Units on a scale||Standard Deviation|Mean
776267|NCT00762528|Primary|8-iso-prostaglandinF2α (8-iso-PGF2α)|Inflammatory biomarker found in gingival crevicular fluid (GCF). Presence in GCF may indicate tissue damage as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis.|29 days|||pg/µl||Standard Deviation|Log Mean
776268|NCT00762528|Primary|Nuclear Factor Kappa B Ligand (RANK-L)|Receptor activator found in gingival crevicular fluid (GCF). Presence in GCF may indicate tissue damage as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis.|29 days|||pg/µl||Standard Deviation|Log Mean
776269|NCT00762528|Primary|Interleukin-6 (IL-6)|Inflammatory biomarker found in gingival crevicular fluid (GCF). Higher Levels found in GCF may be a factor in tissue destruction as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis.|29 days|||pg/µl||Standard Deviation|Log Mean
776270|NCT00762528|Secondary|Bleeding on Probing (BOP)|Presence or absence of bleeding to manual probing as a dichotomous variable as follows: 0 = No bleeding within 10 seconds after probing, 1 = Bleeding within 10 seconds after probing.|29 days|||Units on a scale||Standard Deviation|Mean
776271|NCT00762528|Secondary|Dental Plaque Index (PI)|measurement of supragingival dental plaque on scale of 0-3. 0=No plaque in gingival area,1=a film of plaque adhering to the free gingival margin and the adjacent tooth,2=Moderate accumulation of soft deposits within the gingival pocket and on the gingival margin and/or adjacent tooth-visible by the naked eye, 3=Abundance of soft matter within the gingival pocket and/or gingival margin and adjacent tooth surfaces.|29 days|||Units on a scale||Standard Deviation|Mean
776272|NCT00762528|Primary|Interleukin - 1 Beta (IL-ß)|Inflammatory biomarkers found in gingival crevicular fluid (GCF) that may be a factor in oral tissue destruction as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis.|29 days|||pg/µl||Standard Deviation|Log Mean
776273|NCT00762528|Primary|Prostaglandin E2 (PGE2)|Inflammatory biomarker found in gingival crevicular fluid (GCF). Higher Levels found in GCF may be a factor in tissue destruction as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis.|29 days|||pg/µl||Standard Deviation|Log Mean
776274|NCT00762528|Primary|Gingival Index (GI)|"Gingival Index(GI)recorded on scale of 0-3 detailed below:
0=normal gingiva, 1=Mild inflammation(slight change in color, slight edema)no bleeding on palpation,2=Moderate inflammation(redness,edema,glazing)bleeding upon probing, 3=Severe inflammation(marked redness,edema)ulceration & tendency to spontaneously bleed"|29 days|||units on a scale||Standard Deviation|Mean
776276|NCT00762606|Primary|Posterior Capsule Opacification Evaluation|The number of subjects with Posterior Capsular Opacification (PCO) for 12 months post-surgery of the study eye. PCO may occur after cataract surgery and is caused by residual lens epithelial cells that remain in the capsular bag after surgery and undergo proliferation, migration, and fibrous metaplasia. PCO was evaluated via slit lamp. A lower PCO rate is better.|12 months after surgery|||participants|||Number
776277|NCT00762619|Primary|Veillonella sp.(DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error (SEM)|6 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
776278|NCT00762619|Primary|Veillonella sp.(DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error (SEM)|3 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
776279|NCT00762619|Primary|Veillonella sp.(DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error (SEM).|6 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
776280|NCT00762619|Primary|Veillonella sp.(DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error (SEM)|3 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
776281|NCT00762619|Primary|T.Forsythia (DNA Probe Analysis)- Dental Implants|14 microorganisms were identified via DNA probe analysis for both Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|6 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
776282|NCT00762619|Primary|T.Forsythia (DNA Probe Analysis)- Dental Implants|14 microorganisms were identified via DNA probe analysis for both Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|3 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
776283|NCT00762619|Primary|T.Forsythia (DNA Probe Analysis)-Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|6 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
776284|NCT00762619|Primary|T.Forsythia (DNA Probe Analysis)- Natural Teeth|14 microorganisms were identified via DNA probe analysis for both natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|3 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
776285|NCT00762619|Primary|Streptococci (DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means )SEM).|6 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
776286|NCT00762619|Primary|Streptococci (DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means )SEM).|3 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
776287|NCT00762619|Primary|Streptococci (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|6 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
776288|NCT00762619|Primary|Streptococci (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means )SEM).|3 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
776289|NCT00762619|Primary|Solobacterium (S.Moorei)(DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|6 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
776290|NCT00762619|Primary|Solobacterium (S.Moorei)(DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|3 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
776291|NCT00762619|Primary|Solobacterium (S.Moorei)(DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error (SEM).|6 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
776292|NCT00762619|Primary|Solobacterium (S.Moorei)(DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|3 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
776293|NCT00762619|Primary|P.Melaninogenica (DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|6 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
776294|NCT00762619|Primary|P.Melaninogenica (DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|3 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
776295|NCT00762619|Primary|P.Melaninogenica (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for both natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|6 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
776296|NCT00762619|Primary|P.Melaninogenica (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|3 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
776297|NCT00762619|Primary|P.Intermedia (DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|6 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
776298|NCT00762619|Primary|P.Intermedia (DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|3 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
776299|NCT00762619|Primary|P.Intermedia (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|6 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
776300|NCT00762619|Primary|P.Intermedia (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|3 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
776301|NCT00762619|Primary|P.Gingivalis (DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error of means (SEM)|6 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
776302|NCT00762619|Primary|P.Gingivalis (DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error of means (SEM)|3 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
776303|NCT00762619|Primary|P.Gingivalis (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM)|6 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
776304|NCT00762619|Primary|P.Gingivalis (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error of means (SEM)|3 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
776305|NCT00762619|Primary|Neissera sp. (DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|6 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
776306|NCT00762619|Primary|Neissera sp. (DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|3 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
776307|NCT00762619|Primary|Neissera sp. (DNA Probe Analysis) Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).|6 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
776308|NCT00762619|Primary|Neissera sp. (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|3 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
776309|NCT00762619|Primary|F.Nucleatum (DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM)determined by using baseline adjusted means including standard error of means (SEM).|6 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
776310|NCT00762619|Primary|F.Nucleatum (DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM)determined by using baseline adjusted means including standard error of means (SEM).|3 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
776311|NCT00762619|Primary|F.Nucleatum (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error of means (SEM)|6 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
776312|NCT00762619|Primary|F.Nucleatum (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM)determined by using baseline adjusted means including standard error of means (SEM).|3 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
776313|NCT00762619|Primary|E.Saburreum (DNA Probe Analysis) - Dental Implant|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|6 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
776314|NCT00762619|Primary|E.Saburreum (DNA Probe Analysis) - Dental Implant|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|3 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
776315|NCT00762619|Primary|E.Saburreum (DNA Probe Analysis)- Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM)detemined by using baseline adjusted means including standard error of means (SEM).|6 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
776316|NCT00762619|Primary|E.Saburreum (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|3 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
776317|NCT00762619|Primary|E.Corrodens (DNA Probe Analysis) - Dental Implant|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM)determined by baseline adjusted means including standard error of means (SEM).|6 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
776318|NCT00762619|Primary|E.Corrodens (DNA Probe Analysis) - Dental Implant|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM)determined by baseline adjusted means including standard error of means (SEM).|3 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
776319|NCT00762619|Primary|E.Corrodens (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM)determined by baseline adjusted means including standard error of means (SEM).|6 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
776320|NCT00762619|Primary|E.Corrodens (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM)determined by baseline adjusted means including standard error of means (SEM).|3 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
776321|NCT00762619|Primary|Capnocytophaga sp. (DNA Probe Analysis) - Dental Implant|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).|6 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
776322|NCT00762619|Primary|Capnocytophaga sp. (DNA Probe Analysis) - Dental Implant|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).|3 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
776323|NCT00762619|Primary|Capnocytophaga sp. (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).|6 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
776324|NCT00762619|Primary|Capnocytophaga sp. (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).|3 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
776325|NCT00762619|Primary|C.Rectus (DNA Probe Analysis) - Dental Implant|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).|6 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
776326|NCT00762619|Primary|C.Rectus (DNA Probe Analysis) - Dental Implant|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).|3 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
776327|NCT00762619|Primary|C.Rectus (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).|6 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
776328|NCT00762619|Primary|C.Rectus (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).|3 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
776329|NCT00762619|Primary|A.Actinomycetemcomitans (DNA Probe Analysis)- Dental Implant|14 microorganisms were identified via DNA probe analysis for Dental Implant. Data point is Least means square (LSM) determined by baseline adjusted means including Standard Error of Means (SEM).|6 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
776330|NCT00762619|Primary|A.Actinomycetemcomitans (DNA Probe Analysis)- Dental Implant|14 microorganisms were identified via DNA probe analysis for Dental Implant. Data point is Least means square (LSM) determined by baseline adjusted means including Standard Error of Means (SEM).|3 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
776331|NCT00762619|Primary|A.Actinomycetemcomitans (DNA Probe Analysis)- Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data point is Least means square (LSM) determined by baseline adjusted means including Standard Error of Means (SEM).|6 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
776332|NCT00762619|Primary|A.Actinomycetemcomitans (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are Least means square (LSM)determined by baseline adjusted means including Standard Error of means (SEM).|3 months|||Log cfu (Colony Forming Units)||Standard Error|Least Squares Mean
776333|NCT00762619|Primary|Gingival Bleeding on Probing (BOP) Using the Modified Sulcus Bleeding Index for Implants|Gingival bleeding on probing (BOP) using the modified sulcus bleeding index for implants. Scale equals 0 = No bleeding when periodontal probe is passed along the gingival margin;1 = Isolated bleeding spots visible;2 = Blood forms a confluent red line on the gingival margin;3 = Heavy or profuse bleeding.|6 months|||Units on a scale||Standard Deviation|Mean
776334|NCT00762619|Primary|Gingival Bleeding on Probing (BOP) Using the Modified Sulcus Bleeding Index for Implants|Gingival bleeding on probing (BOP) using the modified sulcus bleeding index for implants. Scale equals 0 = No bleeding when periodontal probe is passed along the gingival margin;1 = Isolated bleeding spots visible;2 = Blood forms a confluent red line on the gingival margin;3 = Heavy or profuse bleeding.|3 months|||Units on a scale||Standard Deviation|Mean
776335|NCT00762619|Primary|Gingival Bleeding on Probing (BOP) Using Sulcus Bleeding Index for Teeth|Sulcus bleeding index for teeth is explained here. Gums around teeth are scored:0 = gingiva of normal texture & color, no bleeding;1 = gingiva normal, bleeds on probing;2 = bleeding on probing,change in color, no oedema;3 = bleeding on probing,change in color, slight oedema;4 = bleeding on probing,change in color, obvious oedema;5 = bleeding on probing, spontaneous bleeding,change in color,marked oedema.|6 months|||Units on a scale||Standard Deviation|Mean
776713|NCT00768651|Primary|Mean Daily Insulin Use (U/Day) After 6 Months of Therapy|Mean daily insulin use was calculated from the three days prior to study visits and performed at baseline, 3, 6, and 9 months.|6 months||||||
776336|NCT00762619|Primary|Gingival Bleeding on Probing (BOP) Using Sulcus Bleeding Index for Teeth|Sulcus bleeding index for teeth is explained here. Gums around teeth are scored:0 = gingiva of normal texture & color, no bleeding;1 = gingiva normal, bleeds on probing;2 = bleeding on probing,change in color, no oedema; 3 = bleeding on probing,change in color, slight oedema;4 = bleeding on probing, change in color, obvious oedema;5=bleeding on probing, spontaneous bleeding, change in color, marked oedema.|3 months|||Units on a scale||Standard Deviation|Mean
776337|NCT00762619|Primary|Löe-Silness Gingival Index Score (GI)- Dental Implants|Gingivitis Score (GI) is defined: 0 = Absence of inflammation,1 = Mild inflammation-slight change in color and little change in texture,2 = Moderate inflammation-moderate glazing,redness,edema & hypertrophy,3 = Severe inflammation-marked redness and hypertrophy tendency for spontaneous bleeding. Each tooth is scored on 6 surfaces:mesio-facial;2)mid-facial;3)disto-facial;4)mesio-lingual;5)mid-lingualand 6)disto-lingual. A whole mouth score=adding all the GI scores & dividing by the total of number of sites scored. 3rd molars and teeth with restorations or crowns will be excluded.|6 months|||units on a scale||Standard Deviation|Mean
776338|NCT00762619|Primary|Löe-Silness Gingival Index Score (GI)- Dental Implants|Gingivitis Score (GI) is defined: 0 = Absence of inflammation,1=Mild inflammation-slight change in color and little change in texture,2 = Moderate inflammation-moderate glazing,redness,edema & hypertrophy,3 = Severe inflammation-marked redness and hypertrophy tendency for spontaneous bleeding. Each tooth is scored on 6 surfaces:mesio-facial;2)mid-facial;3)disto-facial;4)mesio-lingual;5)mid-lingualand 6)disto-lingual. A whole mouth score=adding all the GI scores & dividing by the total of number of sites scored. 3rd molars and teeth with restorations or crowns will be excluded.|3 months|||units on a scale||Standard Deviation|Mean
776339|NCT00762619|Primary|Löe-Silness Gingival Index Score (GI) - Natural Teeth|Gingivitis score(GI) is defined: 0 = Absence of inflammation,1 = Mild inflammation-slight change in color and little change in texture,2 = Moderate inflammation-moderate glazing,redness,edema & hypertrophy,3 = Severe inflammation-marked redness and hypertrophy tendency for spontaneous bleeding.Each tooth is scored on 6 surfaces:mesio-facial;2)mid-facial;3)disto-facial;4)mesio-lingual;5)mid-lingualand 6)disto-lingual. A whole mouth score = adding all the GI scores & dividing by the total of number of sites scored. 3rd molars and teeth with restorations or crowns will be excluded.|6 months|||units on a scale||Standard Deviation|Mean
776340|NCT00762619|Primary|Löe-Silness Gingival Index Score (GI) - Natural Teeth|Gingivitis score(GI) is defined: 0 = Absence of inflammation,1 = Mild inflammation–slight change in color and little change in texture,2 = Moderate inflammation–moderate glazing,redness,edema & hypertrophy,3 = Severe inflammation–marked redness and hypertrophy tendency for spontaneous bleeding. Each tooth is scored on 6 surfaces:mesio-facial;2)mid-facial;3)disto-facial;4)mesio-lingual;5)mid-lingualand 6)disto-lingual. A whole mouth score = adding all the GI scores & dividing by the total of number of sites scored. 3rd molars and teeth with restorations or crowns will be excluded.|3 months|||units on a scale||Standard Deviation|Mean
776341|NCT00762619|Primary|Mombelli Plaque Index (mPI) for Dental Implants|"Modified Plaque Index (mPI) is a dental plaque scale as follows 0 = No plaque,
1 = Separate flecks of plaque at the cervical margin;2 = Plaque can be seen by naked eye.3 = Abundance of soft matter. The lower the number the less plaque is present on the tooth."|6 months|||units on a scale||Standard Deviation|Mean
776342|NCT00762619|Primary|Mombelli Plaque Index (mPI) for Dental Implants|"Modified Plaque Index (mPI) is a dental plaque scale as follows 0 = No plaque,
1 = Separate flecks of plaque at the cervical margin;2 = Plaque can be seen by naked eye.3 = Abundance of soft matter. The lower the number the less plaque is present on the tooth."|3 months|||units on a scale||Standard Deviation|Mean
776343|NCT00762619|Primary|Mombelli Plaque Index (mPI) for Natural Teeth|"Modified Plaque Index (mPI) is a Dental plaque scale as follows 0 = No plaque,
1 = Separate flecks of plaque at the cervical margin;2 = Plaque can be seen by naked eye.3 = Abundance of soft matter. The lower the number the less plaque is present on the tooth."|6 months|||units on a scale||Standard Deviation|Mean
776344|NCT00762619|Primary|Mombelli Plaque Index (mPI) for Natural Teeth|"Modified Plaque Index (mPI)is a Dental plaque scale as follows 0 = No plaque,
1 = Separate flecks of plaque at the cervical margin;2 = Plaque can be seen by naked eye.3 = Abundance of soft matter. The lower the number the less plaque is present on the tooth."|3 months|||units on a scale||Standard Deviation|Mean
776345|NCT00762645|Secondary|Number of Patients With Peripheral Anterior Synechiae (PAS)||Week 12 Visit|||Participants|||Number
776346|NCT00762645|Primary|Mean Intraocular Pressure (IOP)||4PM at Week 12 Visit|||millimeters mercury (mm Hg)||Standard Deviation|Mean
776347|NCT00762723|Primary|Clinical Outcomes (Oswestry Disability Index, SF-12, Numeric Pain Rating Scale, Surgeon Assessment, Patient Self Assessment, Radiological Assessment)|- Fusion Assessment|Pre-operative, Operative; Follow-ups at 3 Months, 6 Months, 12 Months, and 24 Months|Data not analyzed because study was stopped due to slow enrollment.|||||
776348|NCT00762762|Primary|TNF-α (Tumor Necrosis Factor - Alpha)|Blood drawn from subjects to determine the level of TNF-α (Tumor necrosis factor - alpha). TNF-α is a pleiotropic inflammatory cytokine involved in systemic inflammation.|12 months|||pg/ml||Standard Deviation|Mean
776349|NCT00762762|Primary|IL-6 (Interleukin - 6)|Levels of Interleukin - 6 (GCF IL-6) found in blood drawn from subjects. Indication of systemic inflammation in the body.(weight in picagrams)|12 months|||pg/ml||Standard Deviation|Mean
776350|NCT00762762|Primary|C-Peptide|C-Peptide levels in blood indicate whether or not a person is producing insulin|12 months|||ng/ml||Standard Deviation|Mean
776351|NCT00762762|Primary|High Sensitivity CRP (C-Reactive Protein)|CRP is a protein found in the blood and is a marker for inflammation in the body. Inflammation plays a role in the initiation and progression of cardiovascular disease.|12 months|||µg/ml||Standard Deviation|Mean
776352|NCT00762762|Primary|HbA1c Levels in Blood|Blood is taken from each subject and HbA1c levels were measured at 12 months by Queensland Health Pathology Scientific Services (QHPSS). This test measures the glycated hemoglobin in the blood.|12 months|||percentage of HbA1c levels||Standard Deviation|Mean
776353|NCT00762788|Primary|Incidence of Adverse Events|Occurrence of any Adverse Event by study lens. Incidence was calculated as the number of subjects with event divided by the total number of subjects assigned to that lens type.|52 weeks|Subjects who were enrolled and dispensed lenses.||percentage of participants||95% Confidence Interval|Number
776714|NCT00768651|Primary|Number of Participants With Fasting Plasma Glucose (FPG) < 7 mmol/l After 6 Months of Therapy||6 months||||||
776354|NCT00762788|Primary|Incidence of Corneal Infiltrative Events|Extended wear is defined as 7 days, 6 nights of lens wear, weekly replacement of lenses. Incidence was calculated as the number of subjects with event divided by the total number of subjects assigned to that lens type.|52 weeks|Subjects who were enrolled and dispensed lenses.||percentage of participants||95% Confidence Interval|Number
776355|NCT00762853|Primary|Triclosan Concentration in Dental Plaque|Triclosan is analyzed by gas chromatography (GC) with Atomic Emission Detection (480 nm) and quantitated by determining the ration of the peak height of triclosan to the peak height of an internal standard and relating the result to corresponding ratios of calibration standards.|12 hours|||ppm levels of triclosan||Standard Deviation|Mean
776356|NCT00762892|Secondary|Change From Baseline in Homocysteine at 6 Months||Baseline and 48 weeks|||umol/L||Standard Deviation|Mean
776357|NCT00762892|Secondary|Change From Baseline in Interleukin-6 (IL-6) at 48 Weeks||Baseline and 48 weeks|||pg/mL||Standard Deviation|Mean
776358|NCT00762892|Primary|Change From Baseline in Log HIV Viral Load at 48 Weeks||Baseline and 48 weeks|||copies/mL||Standard Deviation|Mean
776359|NCT00762892|Secondary|Change From Baseline in Lipids at 48 Weeks||Baseline and 48 weeks|||mg/dL||Standard Deviation|Mean
776360|NCT00762892|Primary|Change From Baseline in CD4 Count at 48 Weeks||Baseline and 48 weeks|||cells/uL||Standard Deviation|Mean
776361|NCT00762970|Primary|Axial Length (Axial Elongation)|Axial length was measured with the IOLMaster at baseline and every 6 months post-baseline for 2 years. Axial length was descriptively summarized for each follow-up.|Baseline and every 6 months post-baseline for 2 years|Analysis was conducted on all randomized subjects who have at least one data point.||millimeter (mm)|Participants|Standard Deviation|Mean
776362|NCT00762970|Primary|Spherical Equivalent Refraction|Spherical equivalent refraction was computed from the sphero-cylindrical refraction measured with an open-field auto refractor (WAM-5500) and descriptively summarized for each follow-up. Higher spherical refraction indicates progression in Myopia.|Baseline and every 6 months post-baseline for 2 years|Analysis was conducted on all randomized subjects who have at least one data point.||diopter (D)|Participants|Standard Deviation|Mean
776363|NCT00762996|Secondary|Lens Comfort|A weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1=most negative response to 5=most positive was used to derive comfort outcomes. The analysis shows the difference in outcome between the test and control.>0 = comfortable, <0 = uncomfortable|1 week|||Units on a scale||Standard Error|Least Squares Mean
776364|NCT00762996|Primary|Distance Visual Acuity|logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.|1 week|||logMar||Standard Error|Least Squares Mean
776365|NCT00763009|Secondary|To Determine the Clinical Significance of Variations in Adenosine Transfer Function on Coronary Flow.||6-12 months||||||
776366|NCT00763009|Primary|To Determine if There is a Subgroup of Patients That Have an Abnormal Adenosine Transporter Expression, or Abnormal Adenosine Transporter Protein Function.|To determine if there is a subgroup of patients that have an abnormal adenosine transporter expression, or abnormal adenosine transporter protein function. All were responsive Study terminated due to difficulty enrolling|6-12 months|"All patients responded. Function and Expression of the Transporter were therefore not performed.
The study was terminated due to poor enrollment"|||||
776367|NCT00763048|Primary|Metabolite Associated With Inflammation (Xanthine)|One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present.Data is after 6 weeks use of the study treatment.|6 weeks|||ion count||Standard Deviation|Mean
776368|NCT00763048|Primary|Metabolite Associated With Inflammation (Putrescine)|One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.|6 weeks|||ion count||Standard Deviation|Mean
776369|NCT00763048|Primary|Metabolite Associated With Inflammation (Phenylalanine)|One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.|6 weeks|||ion count||Standard Deviation|Mean
776370|NCT00763048|Primary|Metabolite Associated With Inflammation (Lysine)|One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.|6 weeks|||ion count||Standard Deviation|Mean
776371|NCT00763048|Primary|Metabolite Associated With Inflammation (Leucine)|One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.|6 weeks|||ion count||Standard Deviation|Mean
776372|NCT00763048|Primary|Metabolite Associated With Inflammation (Isoleucine)|One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.|6 weeks|||ion count||Standard Deviation|Mean
776373|NCT00763048|Primary|Metabolite Associated With Inflammation (Inosine)|One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.|6 weeks|||ion count||Standard Deviation|Mean
776542|NCT00767000|Primary|Percentage of Participants Who Experienced at Least One Adverse Event||Entire study including 54-week study and 104-week extension|Full analysis set. Includes additional participants enrolled in the MK-0941 40 mg and placebo groups to enhance evaluation of the safety profile of MK-0941.||percentage of participants|||Number
776374|NCT00763048|Primary|Metabolite Associated With Inflammation (Hypoxanthine)|One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.|6 weeks|||ion count||Standard Deviation|Mean
776375|NCT00763048|Primary|Metabolite Associated With Inflammation (Choline)|One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.|6 weeks|||ion count||Standard Deviation|Mean
776376|NCT00763048|Primary|Metabolite Associated With Inflammation (Cadaverine)|One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.|6 weeks|||ion count||Standard Deviation|Mean
776377|NCT00763061|Secondary|Mean IOP Change at 4 PM|Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.|Baseline to Week 12 - at 4 PM|||mmHg||Standard Deviation|Mean
776378|NCT00763061|Primary|Week 12 - Mean IOP At 4 PM|Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.|At the 4 PM time point for the patient's worse eye.|||mmHg||Standard Deviation|Mean
776379|NCT00763061|Secondary|Mean IOP Change From Baseline at 9 AM|Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.|Baseline to Week 12 - at 9 AM|||mmHg||Standard Deviation|Mean
776380|NCT00763061|Primary|Mean Intraocular Pressure (IOP) at 9 AM|Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.|At Week 12 - At the 9 AM time point for the patient's worse eye.|||millimeters mercury (mmHg)||Standard Deviation|Mean
776381|NCT00763139|Secondary|ESR|sed rate|baseline and after 8 weeks on either placebo or pioglitazone|||mm/hr||Standard Deviation|Mean
776382|NCT00763139|Secondary|C-reactive Protein (CRP)||Measured after 8 weeks of treatment|||mg/dl||Standard Deviation|Mean
776383|NCT00763139|Primary|Homeostasis Model Assessment (HOMA) for Insulin Sensitivity|Homa is a measure of insulin sensitivity, using glucose measured in mmol/L and insulin measured in milliUnits per liter (mU/L) Calculated using the formula Glucose * Insulin/22/5|Measured after 8 weeks of treatment|||units on a scale||Standard Deviation|Mean
776384|NCT00763139|Primary|Disease Activity Score Based on 28-joint Disease Activity Score (DAS28)|A measure of disease activity based upon tender joint count of 28 joints, swollen joint count of 28 joints, erythrocyte sedimentation rate, and global disease activity (GH) as reported by participant. Calculation is as follows: DAS28=0.56*sqrt(t28) + 0.28*sqrt(sw28) + 0.70*Ln(ESR) + 0.014*GH|Measured after 8 weeks of treatment|||units on a scale||Standard Deviation|Mean
776385|NCT00763243|Primary|Behavior Rating Inventory of Executive Function (BRIEF) - Working Memory Subscale Raw Score (Construct Measured: Behavioral Attention-Concentration and Working Memory)|"The BRIEF is a parent-report questionnaire of executive functioning behaviors in children. For each item, parents rate whether the child engages in the behavior never (=1), sometimes (=2), or often (=3). Raw scores for subscales are sums of item scores. The Working Memory subscale consists of 10 items asking about attention, concentration, and active controlled memory. Working Memory subscale raw scores are measures of attention, concentration, and working memory, and range from 10 to 30. Higher raw scores indicate more problems with attention, concentration, and working memory."|Administered at Screening Visit, Pretraining Visit (2-5 weeks later), Posttraining Visit (5 weeks after Pretraining Visit), 1 month follow-up visit (1 month after Posttraining Visit), and 6 month follow-up visit (6 months after Posttraining Visit)|||Scores on a scale||Standard Deviation|Mean
776386|NCT00763243|Primary|Spatial Span Total Raw Score (Construct Measured: Visuospatial Short-Term/Working Memory)|This is a measure of memory for sequential spatial locations (forward and backward), based on the subject touching one of 10 blocks in the same sequence (forward) or in the reverse sequence (backward) that they were touched by the examiner. This subtest is based on the WISC-IV-Integrated Spatial Span subtest. The examiner points to blocks on a board, sequentially, starting with a sequence of two blocks (locations), which increase by 1 block (location) after 2 sequences are presented at each span length. The test is discontinued when 2 items are missed at the same spatial span length. Raw score is the number of items (complete sequences) answered correctly. The Spatial Span test is a measure of visuospatial short-term/working memory. Scores range from 0 to 28, with higher scores indicating better visuospatial short-term/working memory.|Administered at Screening Visit, Pretraining Visit (2-5 weeks later), Posttraining Visit (5 weeks after Pretraining Visit), 1 month follow-up visit (1 month after Posttraining Visit), and 6 month follow-up visit (6 months after Posttraining Visit)|||Scores on a scale||Standard Deviation|Mean
776387|NCT00763243|Primary|Digit Span Total Raw Score (Construct Measured: Verbal Short-Term/Working Memory)|This is a measure of digit span forward and digit span backward based on the WISC-III Digit span subtest. Subjects are presented with sequences of single digits, starting with 2 digits, which increase by 1 digit after 2 sequences are presented at each digit length. The test is discontinued when 2 items are missed at the same digit length. Raw score is the number of items (digit sequences) answered correctly. Subjects must recall all digits either in forward (digit span forward) or backward (digit span backward) order. The Digit Span test is a measure of verbal short-term/working memory. Scores range from 0 to 28, with higher scores indicating better verbal short-term/working memory.|Administered at Screening Visit, Pretraining Visit (2-5 weeks later), Posttraining Visit (5 weeks after Pretraining Visit), 1 month follow-up visit (1 month after Posttraining Visit), and 6 month follow-up visit (6 months after Posttraining Visit)|||Scores on a scale||Standard Deviation|Mean
776388|NCT00763256|Primary|P. Gingivalis|Subgingival plaque samples were collected from all interproximal (mesial) sites and pooled prior to assessment. The samples will be analysed for the presence of P. gingivalis, using real time PCR to quantitate the numbers of bacteria. P. gingivalis is a non-motile, gram negative, anaerobic, pathogenic bacteria. It is linked to periodontal disease and causes collagen degradation.|12 months|||Pg/ng DNA||Inter-Quartile Range|Median
776389|NCT00763256|Primary|Gingivitis Score (GI)|"Units on a scale 0 to 3 (0 = no inflammation,
1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)"|12 months|||Units on a scale||Standard Deviation|Mean
776390|NCT00763256|Primary|C-Peptide|C-Peptide levels in blood indicate whether or not a person is producing insulin. This peptide is usually found in equal levels to insulin. C-peptide levels measured as a means of distinguishing type 1 diabetes and type 2 diabetes. Blood is taken from each subject and C-Peptide levels were measured at 12 months by Queensland Health Pathology Scientific Services (QHPSS).|12 months|||nmol/L||Standard Deviation|Mean
776391|NCT00763256|Primary|High Sensitivity CRP (C-Reactive Protein)|CRP is a protein found in the blood and is a marker for inflammation in the body. Inflammation plays a role in the initiation and progression of cardiovascular disease. Blood is taken from each subject and CRP levels were measured at 12 months by Queensland Health Pathology Scientific Services (QHPSS).|12 months|||mg/L||Standard Deviation|Mean
776392|NCT00763256|Primary|HbA1c Levels in Blood|Glycated hemoglobin (HbA1c) is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. In this study, blood is taken from each subject and HbA1c levels were measured at 12 months by Queensland Health Pathology Scientific Services (QHPSS).|12 months|||Percentage||Standard Deviation|Mean
776393|NCT00763269|Secondary|Air Blast Hypersensitivity (8 Week)|"Examiner rates the response to stimulation of hypersensitive teeth using a jet of air (constant stimulus on the basis of duration, pressure, temperature, distance from target). Response is rated based on the Schiff Cold Air Sensitivity Scale.This analog scale scores for the tooth is 0,1,2 or 3:0No subject response to stimulus1responds but will continue2responds and moves or requests discontinuation3Painful response to stimulus, discontinuation requested. The lower the score, the lower the hypersensitivity.Scores per study subject are recorded as mean scores of two hypersensitive teeth."|8 weeks|||units on a scale||Standard Deviation|Mean
776394|NCT00763269|Secondary|Air Blast Hypersensitivity (4 Week)|Examiner rates the response to stimulation of hypersensitive teeth using a jet of air (constant stimulus on the basis of duration, pressure, temperature, distance from target). Response is rated based on the Schiff Cold Air Sensitivity Scale.This analog scale scores for the tooth is 0,1,2 or 3:“0”No subject response to stimulus“1”responds but will continue“2”responds and moves or requests discontinuation“3”Painful response to stimulus, discontinuation requested. The lower the score, the lower the hypersensitivity.Scores per study subject are recorded as mean scores of two hypersensitive teeth.|4 weeks|||units on a scale||Standard Deviation|Mean
776395|NCT00763269|Primary|Hypersensitivity Tactile (Yeaple Probe)|Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 50 grams of force are applied to hypersensitive tooth until pain elicited. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. For Tactile Hypersensitivity: The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitivity. Hypersensitivity scores on a per study subject basis are recorded as mean scores of two hypersensitive teeth|8 weeks|||Units on a scale||Standard Deviation|Mean
776396|NCT00763269|Primary|Hypersensitivity Tactile(Yeaple Probe)|Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 50 grams of force are applied to hypersensitive tooth until pain elicited. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. For Tactile Hypersensitivity: The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitivity. Hypersensitivity scores on a per study subject basis are recorded as mean scores of two hypersensitive teeth|4 weeks|||units on a scale||Standard Deviation|Mean
776397|NCT00763282|Secondary|Mean Number of Skin-related Admissions|Post-discharge skin-related hospitalizations were for both groups (SM+MI vs. ED) but not as study-related or as an adverse event. This study examined an outpatient intervention during which rehospitalization could be triggered by the participants' early reporting of skin breakdown.|Discharge to end of study (6 months)|Mean number of skin-related post-discharge admissions (ICD9 code =707.xx)||admissions/participant||Standard Deviation|Mean
776398|NCT00763282|Primary|Skin Status|Skin worsening was defined as when a participant with an open wound at the time of discharge is found to have >20% wound area at 3 or 6 months post-discharge (including new wounds and reopened wounds). Worsening was also defined as a when a participant with a closed wound at discharge is found to have a new or reopened wound at 3 or 6 months post-discharge.|Admission (Baseline), 3 months, 6 months|||participants|||Number
776399|NCT00763282|Primary|Any Skin Worsening|Skin worsening was defined as when a participant with an open wound at the time of discharge is found to have >20% wound area at 3 or 6 months post-discharge (including new wounds and reopened wounds). Worsening was also defined as a when a participant with a closed wound at discharge is found to have a new or reopened wound at 3 or 6 months post-discharge.|6 months|||participants|||Number
776400|NCT00763282|Primary|Skin Behavior Change|"Self-reported improvement in skin care behaviors in the SM+MI versus ED control intervention arms.
The study reported the number of guideline-recommended skin care behaviors, assessed by the Skin Care Behavior Checklist, a self-report measure of adherence to 8 skin care behaviors for each participant.The difference in the average percentage of the 8 behaviors adhered to by each participant was measured for the different intervention arms from admission (baseline) to 3 and 6 months post-discharge."|Admission (Baseline), 3 months, 6 months|||% Change||Standard Deviation|Mean
776401|NCT00763282|Primary|Percent of Possible Self-Reported Skin Care Behaviors|"Skin Behavior Change was calculated as the percentage of Self-Reported Behavior at 3 and 6 months (minus the percentage at baseline).
The study reported the number of guideline-recommended skin care behaviors, assessed by the Skin Care Behavior Checklist, a self-reported measure of adherence to 8 guideline recommended skin care behaviors. The average percentage of the 8 behaviors adhered to for each participant was measured by intervention arms at admission (baseline), 3 and 6 months post-discharge."|Admission (Baseline), 3 months, 6 months|||% of Possible Self-Reported Behaviors||Standard Deviation|Mean
776402|NCT00763321|Secondary|Change From Double-blind (DB) Baseline to Final Assessment in Chronic Pain Sleep Inventory (CPSI)|The change from the DB randomization baseline (DB baseline: the last assessment before first dose in the DB period) to the final assessment of the impact of pain on the participant’s sleep. The CPSI utilizes a 100 mm VAS scale for questions of how often the participant had trouble falling asleep because of pain, needed sleeping medication, was awakened by pain during the night, and was awakened by pain in the morning (0 mm = Never and 100 mm = Always); and for rating the overall quality of sleep (0 mm = Very Poor and 100 mm = Excellent). Least squares means and standard errors from 2-way ANCOVA model without interaction.|Double-blind baseline to 4 weeks|The analysis of the secondary outcome measure included all randomized participants who received at least 1 dose of study drug during the DB period (DB intent-to-treat), had a DB baseline assessment, and had at least 1 assessment during the DB period.||scores on a scale||Standard Error|Least Squares Mean
776403|NCT00763321|Primary|Change From Double-blind (DB) Baseline to Final Assessment in Chronic Lower Back Pain (CLBP) Intensity by Visual Analog Scale (VAS)|The change from the DB randomization baseline (DB baseline: the last assessment before first dose in the DB period) to the final assessment in pain intensity, assessed using the CLBP Intensity VAS (0 mm = No Pain and 100 mm = Worst Pain Imaginable). Least squares means and standard errors from 2-way ANCOVA model without interaction.|Double-blind baseline to 4 weeks|The analysis of the primary outcome measure included all randomized participants who received at least 1 dose of study drug during the double-blind period (double-blind intent-to-treat).||scores on a scale||Standard Error|Least Squares Mean
776404|NCT00763360|Secondary|Corneal Clarity|Evaluation of corneal clarity as assessed by levels of aqueous flare and aqueous cells. Evaluations were based on the surgeons judgement and graded on a scale. Aqueous flare was graded on the following scale: No visible flare, mild, moderate, severe. Aqueous cells were graded on the following scale: no cells, 1-20 cells, 10-50 cells, too many cells to count, cells frozen.|2 weeks|Data from subjects for whom this evaluation was not performed is not included in this analysis.||units on a scale|||Number
776405|NCT00763360|Secondary|Change in Corneal Thickness|Change in corneal thickness from baseline, measured in millimeters. Measurement performed by pachymetry.|1 month|Subjects that did not have both baseline and 1 month values were not included in this analysis.||millimeters||Standard Deviation|Median
776406|NCT00763360|Primary|Investigator Reported Space Maintenance|"Maintenance of the anterior chamber/dome during cataract surgery. This was rated by the surgeon in one of 4 categories: Full Chamber Maintained, Working Space Maintained, Shallow, Flat. Space maintenance was reported during Capsulorhexis, Hydrodissection, Phacoemulsification, and IOL insertion."|During surgical procedure|||participants|||Number
776407|NCT00763360|Primary|Endothelial Cell Count Change From Baseline|Change in endothelial cell count compared to baseline. Endothelial cell count peformed by counting of cells on photographic image of endothelium.|one month|Only those participants that had endothelial cell counts at both baseline and follow-up were included in this analysis.||Percent change from baseline||Standard Deviation|Mean
776408|NCT00763386|Secondary|Return to Function (RtF) Via Knee Society Score (Modified)|"Scores were calculated from responses on a modified Knee Society Score by the enrolled subjects for the stated visit intervals.
Grading for the Knee Society Score is based on a scale from 0-100 and results are established follows: 80-100 =Excellent; 70-79 = Good; 60-69 = Fair; and Below 60 = Poor."|6 Weeks to 2 Years Post-op, based on on the intervals listed|||units on a scale||Standard Deviation|Mean
776409|NCT00763386|Primary|Postoperative Range of Motion (ROM)|Postoperative ROM was calculated by taking the measurement of patient flexion minus the measurement of patients' extension.|6 Weeks to 2 Years Post-op, based on on the intervals listed|Analysis was determined by calculating the measurements of the enrolled cases who completed the stated visit interval.||degrees||Standard Deviation|Mean
776410|NCT00763412|Secondary|C-Peptide||2 year|||pg/ml||Full Range|Mean
776411|NCT00763412|Secondary|FEV 1|% of lung function|2 year/end of study|||% lung function||Full Range|Mean
776412|NCT00763412|Secondary|Tanner Stage|Puberty scale measuring 1-5, 1 being least development, 5 being most development.|2 year/end of study|||units on a scale||Full Range|Mean
776413|NCT00763412|Secondary|Wt Z Score||2 year/end of study|||Z score||Full Range|Mean
776414|NCT00763412|Secondary|Inflammatory Markers||2 year/end of study|||pg/ml||Full Range|Mean
776415|NCT00763412|Secondary|Glucose Tolerance|We completed the OGTT at the 2 year/end of study visit.|2-year|||mg/dl||Full Range|Mean
776416|NCT00763412|Primary|CRP||2 year/end of study|||mg/L||Full Range|Mean
776417|NCT00763412|Primary|Body Composition|Reporting % of Fat and Lean body mass|2 year/end of study|||% body mass||Full Range|Mean
776418|NCT00763412|Primary|BMI||2 year/end of study|||Kg/m^2||Full Range|Mean
776419|NCT00757172|Secondary|Number of Participants With Frequent (>=15% Grade 3/4 Incidence) Adverse Events Regardless of Attribution|Adverse events were assessed by NCI CTCAE (Common Terminology Criteria for Adverse Events) v3.0. Grade 1= mild, grade 2= moderate, grade 3= severe, grade 4= life-threatening; and grade 5= death.|Week 1, 3, 5, 7, 9, 4-6 weeks after therapy and within 30 days post surgery|All recruited participants.||participants|||Number
776420|NCT00757172|Secondary|Percentage of Participants With 2-year Disease-free Survival|Disease-free survival was defined as the time from start of study therapy to documentation of disease recurrence. Participants who died without documentation of recurrence were considered to have had tumor recurrence at the time of death unless there was documented evidence that no recurrence occured before death. Participants who failed to return for evaluation after beginning therapy were censored for recurrence on the last day of therapy. Participants who experienced major treatment violations were censored for recurrence on the date the treatment violation occured.|2 years|All registered participants who have met the eligibility criteria.||percentage of participants|||Number
776421|NCT00757172|Secondary|Percentage of Participants With 3-year Overall Survival|Survival time was defined to be the length of time from start of study therapy to death due to any cause or until last follow-up (censored value).|3 years|All registered participants who have met the eligibility criteria.||percentage of participants|||Number
776422|NCT00757172|Secondary|Number of Participants With Near-complete Response Rate (≤ 10% Residual Cancer in Primary Tumor Viable)||Post surgery|All participants who have met the eligibility criteria that have signed a consent form and began treatment.||participants|||Number
776715|NCT00768651|Primary|Number of Participants With HbA1c < 6.0 % After 6 Months of Therapy|HbA1c was measured using method (manufacturer) at baseline, 3, 6 and 9 months.|6 months||||||
776423|NCT00757172|Primary|Number of Participants With Pathologic Complete Response Following Surgery|Pathologic complete response (pCR) was defined as no viable residual tumor cells. A cellular residual mucin pools should be noted but also considered a pathologic complete response.|Post surgery|All participants who have met the eligibility criteria that have signed a consent form and began treatment.||participants|||Number
776424|NCT00757237|Other Pre-specified|Time to Need for Inhaled and/or IV Antipseudomonal Antibiotics for Respiratory Event (Other Than Randomized Treatment)|"Antipseudomonal antibiotic use for respiratory event was determined through event adjudication by a sponsor-independent, blinded review committee.
Use of IV and/or inhaled antibiotics for a respiratory event was compiled from data recorded on the concomitant medications eCRF and compared to reported AEs to determine use for a respiratory event. The time to antibiotic use for a respiratory event was measured in days from baseline (Day 0) to the date of first antibiotic use for a respiratory event or the date of study completion (last visit)/or early withdrawal if censored."|Day 0 to Day 168 (end of study)|Analysis was based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug).||days||95% Confidence Interval|Median
776425|NCT00757237|Other Pre-specified|Number of Respiratory Events Requiring IV and/or Inhaled Antipseudomonal Antibiotics (Other Than Randomized Treatment)|Inhaled and/or IV antipseudomonal antibiotic use for respiratory event was determined through event adjudication by a sponsor-independent, blinded review committee. Use of IV and/or inhaled antipseudomonal antibiotics was compiled from data recorded on the concomitant medications eCRF and compared to reported AEs to determine use for a respiratory event. The time to IV and/or inhaled antipseudomonal antibiotic use was measured in days from baseline (Visit 2) to the date of first antipseudomonal antibiotic use or the date of study completion (last visit)/or early withdrawal if censored.|Day 0 through Day 168 (end of study)|Analysis was based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug).||events|||Number
776426|NCT00757237|Other Pre-specified|Total Number of Respiratory Hospitalizations|Respiratory hospitalizations were determined through the adjudication of events by a sponsor-independent, blinded review committee. Committee members reviewed hospitalizations and determined which were related to respiratory events.|Day 0 to Day 168 (end of study)|Analysis was based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug).||hospitalizations|||Number
776427|NCT00757237|Other Pre-specified|Treatment Satisfaction Questionnaire for Medication (TSQM) - Global Satisfaction Results at Week 20|This 14 item questionnaire consists of 3 subscales that gauge participant perceptions of a medication’s effectiveness, side effects, and convenience. The measure also contains a global satisfaction scale to evaluate overall participant satisfaction. The global satisfaction score is the endpoint reported here. The range of scores is 0 to 100, with higher scores indicating greater satisfaction.|At Week 20|Analysis was based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug).||units on a scale||Standard Error|Least Squares Mean
776428|NCT00757237|Other Pre-specified|Mean Actual Change From Baseline in CFQ-R RSS Score Across 3 Treatment Courses|The CFQ-R is a validated patient-reported outcome tool measuring health-related quality of life for children and adults with CF. The CFQ-R contains both general and CF-specific scales. The endpoint was the average actual change in respiratory symptoms (e.g., coughing, congestion, wheezing) from baseline, assessed with the CFQ-R RSS (range of scores [units]: 0-100; higher scores indicate fewer symptoms) at the end of each treatment course (Weeks 4, 12, and 20).|Baseline and end of treatment Courses 1 (Week 4), 2 (Week 12), and 3 (Week 20)|Analysis was based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug). The LOCF method was used to impute missing data for statistical purposes.||units on a scale||Standard Error|Least Squares Mean
776429|NCT00757237|Other Pre-specified|Actual Change From Baseline in CF Questionnaire - Revised (CFQ-R) Respiratory Symptoms Scale (RSS) Score at Day 28|The CFQ-R is a validated patient-reported outcome tool measuring health-related quality of life for children and adults with CF. The CFQ-R contains both general and CF-specific scales. The endpoint was change in respiratory symptoms (e.g., coughing, congestion, wheezing) from baseline, assessed with the CFQ-R RSS (range of scores [units]: 0-100; higher scores indicate fewer symptoms).|Baseline and end of treatment Course 1 (Day 28)|Analysis was based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug). LOCF method was used to impute missing data for statistical analyses.||Units on a scale||Standard Error|Least Squares Mean
776430|NCT00757237|Secondary|Time to First Respiratory Hospitalization|"This endpoint was determined through the adjudication of events by a sponsor-independent, blinded review committee. Committee members reviewed all hospitalizations and determined which were related to respiratory events.
Details of all hospitalizations, including the dates of admission and discharge, were recorded on the serious adverse event (SAE) eCRF.
Time to first respiratory hospitalization was the number of days from baseline (Visit 2) to the date of first respiratory hospitalization or the date of study completion (last visit) /or early withdrawal if censored."|Day 0 to Day 168 (end of study)|Analysis was based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug).||days||95% Confidence Interval|Median
776431|NCT00757237|Secondary|Time to Need for Intravenous (IV) Antipseudomonal Antibiotics for Respiratory Events|"IV antipseudomonal antibiotic use for a respiratory event was determined through the adjudication of events by a sponsor-independent, blinded review committee.
Use was compiled from data recorded on the concomitant medications electronic case report form (eCRF) and compared to reported adverse events (AEs) to determine use for a respiratory event. The time to IV antipseudomonal antibiotic use was measured in days from baseline (Visit 2) to the date of first IV antipseudomonal antibiotic use or the date of study completion (last visit)/or early withdrawal if censored."|Day 0 to Day 168 (end of study)|Analysis was based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug).||days||95% Confidence Interval|Median
776453|NCT00766415|Secondary|Chronic Obstructive Pulmonary Disease (COPD) Symptom Sputum Score|Mean change in COPD symptom sputum score from baseline to the average of the treatment period. 0= (none) - 4= (severe).|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.||Score on a scale||95% Confidence Interval|Mean
776716|NCT00768651|Primary|Number of Participants Not Using Insulin for at Least One Week After 6 Months of Therapy||6 months||||||
776432|NCT00757237|Secondary|Mean Actual Change From Baseline in FEV1 Percent Predicted Across 3 Treatment Courses in Subjects Who Received Inhaled Tobramycin for >= 84 Days in the 12 Months Prior to Randomization|"Spirometry was performed according to ATS guidelines at each visit. FEV1 percent predicted is a normalized value of FEV1 calculated using the Knudson equation and based upon participant age, gender, and height.
Treatment effect on the average adjusted means for the actual change in FEV1 percent predicted at Visits 4, 6, and 8 (Weeks 4, 12, and 20) was tested by MMRM analysis using the population of participants with prior inhaled tobramycin use of >=84 days in the previous 12 months."|Baseline and end of treatment Courses 1 (Week 4), 2 (Week 12), and 3 (Week 20)|Analysis was based on participants with prior inhaled tobramycin use >= 84 days in the previous 12 months using the ITT analysis set.||actual change in FEV1 percent predicted||Standard Error|Least Squares Mean
776433|NCT00757237|Secondary|Relative Change From Baseline in FEV1 Percent Predicted at Day 28 in Subjects Who Received Inhaled Tobramycin for >= 84 Days in the 12 Months Prior to Randomization|Spirometry was performed according to ATS guidelines. FEV1 percent predicted is a normalized value of FEV1 calculated using the Knudson equation and based upon participant age, gender, and height. Treatment effect on the relative change from baseline in FEV1 percent predicted at Day 28 (Visit 4) was tested using an ANCOVA model-based method, using the population of participants with prior inhaled tobramycin use of >= 84 days in the previous 12 months.|Baseline and end of treatment Course 1 (Day 28)|Analysis was based on participants with previous inhaled tobramycin use of >= 84 days within the previous 12 months using the ITT analysis set. The last observation carried forward (LOCF) method was used to impute missing data for statistical analyses.||percent change in FEV1 percent predicted||Standard Error|Least Squares Mean
776434|NCT00757237|Primary|Mean Actual Change From Baseline in FEV1 Percent Predicted Across 3 Treatment Courses|"Spirometry was performed according to ATS guidelines at each visit. FEV1 percent predicted is a normalized value of FEV1 calculated using the Knudson equation and based upon participant age, gender, and height.
Treatment effect on the average adjusted means for the actual change in FEV1 percent predicted at Visits 4, 6, and 8 (Weeks 4, 12, and 20) was tested by mixed-effect model repeated measures (MMRM) analysis using the ITT population analysis set."|Baseline, and end of treatment Courses 1 (Week 4), 2 (Week 12), and 3 (Week 20)|Analysis was based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug).||actual change in FEV1 percent predicted||Standard Error|Least Squares Mean
776435|NCT00757237|Primary|Relative Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Percent Predicted at Day 28|Spirometry was performed according to American Thoracic Society (ATS) guidelines at each visit. FEV1 percent predicted is a normalized value of FEV1 calculated using the Knudson equation and based upon participant age, gender, and height. Treatment effect on the relative change from baseline in FEV1 percent predicted at Day 28 (Visit 4) was tested using an analysis of covariance (ANCOVA) model-based method.|Baseline and end of treatment Course 1 (Day 28)|Analysis was based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug). The last observation carried forward (LOCF) method was used to impute missing data.||percent change in FEV1 percent predicted||Standard Error|Least Squares Mean
776436|NCT00763451|Other Pre-specified|Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia|Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the patient required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.|First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks|"Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.The Placebo (Two-step Titration) and Placebo (One-step Titration) Arms/Groups were combined as pre-specified in the study protocol"||participants|||Number
776437|NCT00763451|Other Pre-specified|Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|"mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.The Placebo (Two-step Titration) and Placebo (One-step Titration) Arms/Groups were combined as pre-specified in the study protocol"||percentage of participants|||Number
776438|NCT00763451|Secondary|Percentage of Patients Requiring Rescue Therapy During Main 24-Week Period|Routine fasting self-measured plasma glucose (SMPG) and central laboratory FPG (and HbA1c after week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after week 12) were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG >270 milligram/deciliter (mg/dL) (15.0 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 24: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >8.5%. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline up to Week 24|"mITT population. The Placebo (Two-step Titration) and Placebo (One-step Titration) Arms/Groups were combined as pre-specified in the study protocol"||percentage of participants|||Number
776439|NCT00763451|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|"mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.The Placebo (Two-step Titration) and Placebo (One-step Titration) Arms/Groups were combined as pre-specified in the study protocol"||percentage of participants|||Number
776440|NCT00763451|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|"mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.The Placebo (Two-step Titration) and Placebo (One-step Titration) Arms/Groups were combined as pre-specified in the study protocol"||percentage of participants|||Number
776441|NCT00763451|Secondary|Change From Baseline in Body Weight at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|"mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.The Placebo (Two-step Titration) and Placebo (One-step Titration) Arms/Groups were combined as pre-specified in the study protocol"||kilogram||Standard Error|Least Squares Mean
776442|NCT00763451|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|"mITT population. Missing data was imputed using last observation carried forward (LOCF). Here, number of patients analyzed = patients with baseline and at least 1 post-baseline FPG assessment during on-treatment period.The Placebo (Two-step Titration)andPlacebo (One-step Titration)Arms/Groups were combined as pre-specified in the study protocol"||mmol/L||Standard Error|Least Squares Mean
776443|NCT00763451|Primary|Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|"Absolute change = HbA1c value at Week 24 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.
The Placebo (Two-step Titration) and Placebo (One-step Titration) Arms/Groups were combined as pre-specified in the study protocol"|Baseline, Week 24|mITT population:all randomized patients who received at least 1 dose;had baseline,at least 1 post-baseline efficacy assessment, irrespective of compliance with study protocol/procedures. Last observation carried forward used. Number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.||percentage of hemoglobin||Standard Error|Least Squares Mean
776444|NCT00763490|Secondary|Incidence of Acute (Grade II-IV) and Chronic Graft-vs-host Disease(GVHD)|"The percentage of patients with acute GVHD (Grade II-IV) was determined at 100 days. Patients were followed up to 5 years and the percentage of patients that developed chronic GVHD at the end of the study was tabulated.
Acute GVHD is staged and graded (grade 0-IV, where grade 0 is no involvement and involvement increases by grade) by the number and extent of organ involvement. Patients can have involvement of three organs: skin (rash/dermatitis), liver (hepatitis/jaundice), and gastrointestinal tract (abdominal pain/diarrhea)."|Up to 5 years|||percentage of patients||95% Confidence Interval|Number
776445|NCT00763490|Secondary|Cumulative Incidence of Neutrophil and Platelet Engraftment|The failure to achieve a neutrophil count > 500/uL or a platelet count >30.0 x 10e9 /L within 35 days of the stem cell infusion will be defined as primary engraftment failure.|Day 35|||percentage of participants||95% Confidence Interval|Number
776446|NCT00763490|Secondary|Percentage of Patients Alive at the End of the Trial|Event Free Survival (EFS) was determined. Patients were followed up to 5 years (median time of 2.35 years).|5 Years|||percentage of patients||95% Confidence Interval|Number
776447|NCT00763490|Primary|Percentage of Participants Alive at 1 Year After Transplant|One-year survival rate after transplant|1 year|||percentage of participants||95% Confidence Interval|Number
776448|NCT00763698|Primary|Left Ventricular Bipolar Pacing Capture Threshold (Volts)|The mean left ventricular capture threshold (amount of energy needed to pace the heart) is reported. An overall mean capture threshold of < 3 volts is required to meet this endpoint.|3 months|This effectiveness endpoint was carried out on the first 16 patients who had a LV lead bipolar pacing capture threshold measurement at 3 months at 0.5 ms pulse width. This patient cohort is referred to as the “Primary Pacing Capture Threshold Patient Cohort”.||volts||Standard Deviation|Mean
776449|NCT00763698|Primary|Percentage of Successful Left Ventricular Lead Implants|Left ventricular lead implant success rate was calculated as the total number of patients who had a successful implant of the left ventricular QuickFlex Micro Model 1258T lead divided by the total number of patients who had an attempted implant. A successful implant was defined as the placement of the left ventricular lead in the coronary sinus for the purposes of pacing of the left ventricle with connection to the pulse generator.|3 months|All patients with an implant or attempted implant were included in the analysis.||percentage of participants||95% Confidence Interval|Number
776450|NCT00763698|Primary|Freedom From Left Ventricular Lead-related Complications|A Kaplan-Meier survival analysis was carried out for left ventricular lead related complications through 3 months. Percentage of patients who remained free from complications at 3 months was reported.|3 months|Analysis was conducted on the 81 patients with a successful left ventricular lead implant.||percent of participants||95% Confidence Interval|Number
776451|NCT00763750|Primary|Number of Patients Assessed for Toxicity According to CTC Version 3.0||Throughout the entire study until patient is removed from study an average of 6 weeks|||participants|||Number
776452|NCT00766415|Secondary|Adverse Event (AE)|Number of participants with an Adverse Event|1 month|||Participants|||Number
776717|NCT00768651|Secondary|Insulin Dose (U/Day)||After the 3 month washout period||||||
776454|NCT00766415|Secondary|Chronic Obstructive Pulmonary Disease (COPD) Symptom Cough Score|Mean change in COPD symptom cough score from baseline to the average of the treatment period. 0= (none) - 4= (almost constant)|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.||Score on a scale||95% Confidence Interval|Mean
776455|NCT00766415|Secondary|Chronic Obstructive Pulmonary Disease (COPD) Symptom Breathing Score|Mean change in COPD symptom breathing score from baseline to the average of the treatment period. 0= (none) - 4 =(severe).|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.||Score on a scale||95% Confidence Interval|Mean
776456|NCT00766415|Secondary|Chronic Obstructive Pulmonary Disease (COPD) Symptom Night-time Awakenings Score|Mean change in COPD symptom night-time awakening score from baseline to the average of the treatment period. 0=(no symptom)-4=(no sleep)|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.||Score on a scale||95% Confidence Interval|Mean
776457|NCT00766415|Secondary|Peak Expiratory Flow (PEF) Evening|Mean change in Peak Expiratory Flow (PEF) evening from baseline to the average of the treatment period|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.||L/min||95% Confidence Interval|Mean
776458|NCT00766415|Secondary|Peak Expiratory Flow (PEF) Morning|Mean change in Peak Expiratory Flow (PEF) morning from baseline to the average of the treatment period|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.||L/min||95% Confidence Interval|Mean
776459|NCT00766415|Secondary|Clinical Chronic Obstructive Pulmonary Disease (COPD) The Clinical COPD Questionnaire (CCQ)|Change in total CCQ score from baseline to last measurement on treatment. scored on a scale of 0 - 6. 0 =(low symptoms)-6 =(high symptoms)|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.||Scores on a scale||95% Confidence Interval|Mean
776460|NCT00766415|Secondary|Forced Expiratory Volume in 1 Second (FEV1)|Change in Forced Expiratory Volume in 1 second (FEV1) from baseline to end of treatment|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.||percentage change||95% Confidence Interval|Mean
776461|NCT00766415|Primary|Induced Sputum: Total Cells Count|Change in Induced sputum Total cells count from baseline|Before and after 3 week treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.||10^6/g||95% Confidence Interval|Mean
776462|NCT00766415|Primary|Induced Sputum: Epithelial Cells Count (%)|Change in Induced sputum Epithelial cells count (% of total) from baseline|Before and after 3 week treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.||percentage||95% Confidence Interval|Mean
776463|NCT00766415|Primary|Induced Sputum: Lymphocytes Count (%)|Change in Induced sputum Lymphocytes count (% of total) from baseline|Before and after 3 week treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.||percentage||95% Confidence Interval|Mean
776464|NCT00766415|Primary|Induced Sputum: Macrophages Count (%)|Change in Induced sputum Macrophages count (% of total) from baseline|Before and after 3 week treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.||percentage||95% Confidence Interval|Mean
776465|NCT00766415|Primary|Induced Sputum: Neutrophils Count (%)|Change in Induced sputum Neutrophils count (% of total) from baseline|Before and after 3 week treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.||percentage||95% Confidence Interval|Mean
776466|NCT00766415|Primary|Induced Sputum: Eosinophil Count (%)|Change in Induced sputum Eosinophil count (% of total) from baseline|Before and after 3 week treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.||percentage||95% Confidence Interval|Mean
776467|NCT00766415|Primary|Bronchoalveolar Lavage (BAL): Total Cells Count|Change in Bronchoalveolar Lavage (BAL): Total cells count from baseline|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.||10^6/g||95% Confidence Interval|Mean
776468|NCT00766415|Primary|Bronchoalveolar Lavage (BAL): Epithelial Cells Count (%)|Change in Bronchoalveolar Lavage (BAL): Epithelial cells count (% of total) from baseline|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.||percentage||95% Confidence Interval|Mean
776484|NCT00766506|Secondary|Number of Participants Who Require Concomitant Antiemetic Medication|Antiemetic medicines are the drugs which prevent vomiting.|Baseline up to end of study treatment (Hour 72)|The ITT population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours).||Participants|||Number
776469|NCT00766415|Primary|Bronchoalveolar Lavage (BAL): Lymphocytes Count (%)|Change in Bronchoalveolar Lavage (BAL): Lymphocytes count (% of total) from baseline|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.||percentage||95% Confidence Interval|Mean
776470|NCT00766415|Primary|Bronchoalveolar Lavage (BAL): Macrophages Count (%)|Change in Bronchoalveolar Lavage (BAL): Macrophages count (% of total) from baseline|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.||percentage||95% Confidence Interval|Mean
776471|NCT00766415|Primary|Bronchoalveolar Lavage (BAL): Neutrophil Count (%)|Change in Bronchoalveolar Lavage (BAL): Neutrophil count (% of total) from baseline|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.||percentage||95% Confidence Interval|Mean
776472|NCT00766415|Primary|Bronchoalveolar Lavage (BAL): Eosinophil Count (%)|Change in Bronchoalveolar Lavage (BAL): Eosinophil count (% of total) from baseline|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.||percentage||95% Confidence Interval|Mean
776473|NCT00766415|Primary|Aggregated Pathology Score|Composite endpoint subscores: histological grade, immunohistochemistry grade, leucocyte counts. Each subscore measured on scale 1 (normal) to 5 (worst outcome). Composite score summed across the subscores, ranging from 3 (normal) to 15 (worst outcome). Change from baseline.|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.||Score on a scale||95% Confidence Interval|Mean
776474|NCT00766467|Secondary|Number of Grade 3-4 Side Effects at Least Possibly Related to Study Treatment|To assess the side effect profile of armodafinil in patients with malignant gliomas undergoing radiotherapy with or without standard chemotherapy treatment.|56 days|Grade 3 - 4 events at least possibly related to study treatment.||number of incidents|||Number
776475|NCT00766467|Secondary|Change From Baseline in Quality of Life at Days 22, 43 and 56|The effects of treatment on overall health-related quality of life quantified with the general Functional Assessment of Cancer Therapy survey (FACT-G) were measured at baseline, at day 22, at the end of radiation (day 43) and 2 weeks after completion of radiation (day 56). The FACT-G assesses quality of life based on physical, social/family, emotional, and functional well-being. Each item is assessed on a 5-point scale (0 = not at all to 4 = very much). The total FACT-G score can range from 0-108, with higher scores indicating a better quality of life.|baseline, day 22, day 43, and day 56|Analysis included participants with complete or near complete baseline and day 43 data irrespective of the amount of treatment received.||units on a scale||80% Confidence Interval|Median
776476|NCT00766467|Primary|Change From Baseline in Fatigue at Day 43|The primary endpoint was the difference in the 42-day change (baseline vs. day 43) in Functional Assessment of Chronic Illness Therapy-Fatigue scale (FACIT-F scale) between the 2 treatment groups (those patients randomized to receive armodafinil and those randomized to the placebo arm). FACIT-F is a well-validated QOL instrument widely used for the assessment of cancer-related fatigue in clinical trials.5 It consists of the 27-item FACT-G (which assesses QOL based on physical, social/family, emotional, and functional well-being) and the 13-item FACIT-F fatigue subscale (which assesses the impact of fatigue on daily activities). Each item is assessed on a 5-point scale (0 = not at all to 4 = very much). By scoring convention, after appropriate reversal scoring of 11 items, the FACIT-F fatigue subscale (FACIT-fatigue) score ranges from 0 to 52 (lower score indicating more fatigue). A score < 30 indicates severe fatigue.|43 days|Primary analysis included participants with complete or near complete baseline and day 43 data irrespective of the amount of treatment received.||units on a scale||80% Confidence Interval|Median
776477|NCT00766493|Secondary|Neurologic Events|Neurological Events at 30 days post-procedure, including transient ischemic attacks (TIAs).|30 days|||Participants|||Number
776478|NCT00766493|Secondary|Access Site Complications|Access Site Complications defined as the presence of a large hematoma (>5cm or requiring treatment or prolonged hospitalization), fistula or pseudoaneurysm formation, retroperitoneal bleeding or the need for surgical repair postprocedure.|30 days|||Participants|||Number
776479|NCT00766493|Secondary|Clinical Success|Clinical Success defined as GORE Embolic Filter and carotid stent success in the absence of death, emergency endarterectomy, repeat PTA / thrombolysis of the target vessel, and stroke or MI as determined by the Clinical Events Committee. Clinical success will be evaluated from procedure through 24-48 hours postprocedure.|30 days|||Participants|||Number
776480|NCT00766493|Secondary|Device Success|Device Success defined as the number of participants with Technical Success using the GORE Embolic Protection System (i.e., the GORE Embolic Filter device was delivered, placed, and retrieved as outlined in the Instructions for Use).|Post Procedure|||Participants|||Number
776481|NCT00766493|Primary|Composite Major Adverse Event (MAE) Rate of Death, Myocardial Infarction, and Stroke at 30 Days Postprocedure||30 days|EMBOLDEN subjects evaluable for the primary endpoint||Participants|||Number
776482|NCT00766506|Other Pre-specified|Number of Participants Facing Technical Failure of the Device|Technical failure was defined as malfunctioning or failure of device to work appropriately.|Baseline up to end of study treatment (Hour 72)|Safety population included all participants randomly assigned to study treatment and who used either of the study treatment at least once.||Participants|||Number
776483|NCT00766506|Secondary|Number of Participants Who Require Concomitant Non-opioid Analgesics|Non-opioid analgesics are non morphine like medications used to get relieve from pain.|Baseline up to end of study treatment (Hour 72)|The ITT population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours).||Participants|||Number
776543|NCT00767000|Secondary|Percentage of Participants Achieving an HbA1c of <7.0% at Week 54 Who Maintain an HbA1c of <7.0%||Weeks 54, 106 and 158|Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 106 or 158|||||
776485|NCT00766506|Secondary|Number of Participants Who Require Rescue Medication|Rescue medication was defined as a fast-acting medication given besides the study drug that could alleviate pain quickly, but the effects were not long lasting. Morphine was given intravenously as rescue medication for all participants randomly assigned to either treatment group.|Baseline up to Hour 3|The ITT population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours).||Participants|||Number
776486|NCT00766506|Other Pre-specified|Time to Actual Discharge|The time from baseline to the time at which the participant was actually discharged from ward care was recorded as time to actual discharge.|When participant was actually discharged from ward care (assessed up to 258.5 hours)|The ITT population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours).||Hours||95% Confidence Interval|Median
776487|NCT00766506|Secondary|Time to Fit For Discharge (FFD)|Participants were assessed for fulfilling the following FFD criteria: 1- Retaining fluids and food; 2- Passing urine without the aid of a catheter; 3- Bowel sounds and/or opening; 4- Cardiovascular stability; 5- Respiratory stability; 6- No post-operative wound complications; 7- Pain adequately controlled with oral analgesia only; 8- Adequately mobile according to locally acceptable standards for mobility for surgery type and pre-operative expectations. The FFD criteria were answered on a “Yes” or “No” basis. When all criteria were answered as Yes, participant was considered to be FFD.|When participant was FFD (assessed up to 91 hours)|The ITT population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours).||Hours||95% Confidence Interval|Median
776488|NCT00766506|Secondary|Number of Participants With Patient Global Assessment (PGA) of Method of Pain Control|The assessment consist of a categorical evaluation (poor, fair, good or excellent) of the method of pain control by asking following question from the participant: “Overall, would you rate this PCA (participant controlled analgesia) method of pain control as being poor, fair, good, or excellent?”|Hour 72 or early study withdrawal|The ITT population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours). Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.||Participants|||Number
776489|NCT00766506|Secondary|Nurse Ease of Care (EOC) Questionnaire Score|Nurse EOC questionnaire had 22 items and covered 3 aspects of care delivery associated with acute care pain management systems: time, bothersome and satisfaction. Items were scored on a 6-point Likert scale, ranging from ‘not at all’ (Score 0) to ‘a very great deal’ (score 5). The total score was calculated as the mean of the non-missing items for all the questions.|When participant was fit for discharge (FFD) (assessed up to 91 hours)|The ITT population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours).||Units on scale||95% Confidence Interval|Least Squares Mean
776490|NCT00766506|Secondary|Pain Intensity Numerical Rating Scale (NRS)|Pain intensity NRS measured pain intensity experienced by the participant on a scale, 0 to 10, where 0 means no pain and 10 mean the worst possible pain. Participant’s pain intensity was assessed by asking following question to the participant: on a scale 0 to 10 where 0 means no pain, and 10 means the worst possible pain, rate the pain that you have now.|Baseline, Hour 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, study treatment discontinuation or withdrawal, and when participant was fit for discharge (FFD) (assessed up to 91 hours)|The ITT population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours). Here ‘n’ signifies those participants evaluable for this measure at the specified time point for each arm group, respectively.||Unit on Scale||Standard Deviation|Mean
776491|NCT00766506|Primary|Participant’s Evaluation of Mean Ability to Mobilize After Surgery|The ability to mobilize was assessed through a combined analysis of participant’s responses to the following 3 questions: 1-Because of the system/device, I had to be careful when I used my hands; 2-The system/device made it difficult for me to adjust my position in bed; 3-The system/device interfered with my ability to get out of bed and walk around. All 3 items were scored on a 6-point Likert scale, ranging from “not at all” (score 0) to “a very great deal” (score 5). Total ability to mobilize was assessed as average of 3 scores which range from 0 (best mobility) to 5 (worst mobility).|Hour 72 or early study withdrawal|The intention-to-treat (ITT) population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours).||Units on scale||Standard Deviation|Mean
776492|NCT00766532|Primary|Change in Intestinal Calcium Absorption Related to Aromatase Inhibitor Therapy|intestinal calcium absorption|baseline and 6 weeks later|12 subjects provided informed consent but two dropped and did not undergo calcium absorption study visits. 10 subjects completed all calcium absorption study visits.||percent calcium absorption||Standard Deviation|Mean
776493|NCT00766597|Secondary|Change in Plasma HIV RNA PCR|Changes in HIV RNA (copies/mL) from baseline to Week 24 will be presented both in the aggregate and broken down by age cohort.|At Baseline, Week 24|HIV-1 infected ART-experienced participants with CCR5-tropic virus who started treatment in Step II and have reached Week 24. Measure was not analyzed since only one participant reached Week 24, no aggregate results were available for posting, and the individual participant-level data were not posted due to being potentially identifiable.|||||
776494|NCT00766597|Secondary|Change in Polymerase Genome and Envelope Sequence|Number of subjects with changes in genotypic and phenotypic drug resistance to the OBT and to vicriviroc (envelope sequence) from baseline to Week 24 and/or virologic failure will be presented both in the aggregate and broken down by age cohort.|At Baseline, Week 24|HIV-1 infected ART-experienced participants with CCR5-tropic virus who started treatment in Step II and have reached Week 24. Measure was not analyzed since only one participant reached Week 24, no aggregate results were available for posting, and the individual participant-level data were not posted due to being potentially identifiable.|||||
776544|NCT00767000|Secondary|Percentage of Participants Who Achieve an HbA1c of <7.0%||Weeks 106 and 158|Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 106 or 158|||||
776495|NCT00766597|Secondary|Change in CD4 Percent|Change in CD4 percent from baseline to weeks 24 will be presented both in the aggregate and broken down by age cohort.|At Baseline, Week 24|HIV-1 infected ART-experienced participants with CCR5-tropic virus who started treatment in Step II and have reached Week 24. Measure was not analyzed since only one participant reached Week 24, no aggregate results were available for posting, and the individual participant-level data were not posted due to being potentially identifiable.|||||
776496|NCT00766597|Secondary|Change in CD4 Counts|Change in CD4 count from baseline to weeks 24 will be presented both in the aggregate and broken down by age cohort.|At Baseline, Week 24|HIV-1 infected ART-experienced participants with CCR5-tropic virus who started treatment in Step II and have reached Week 24. Measure was not analyzed since only one participant reached Week 24, no aggregate results were available for posting, and the individual participant-level data were not posted due to being potentially identifiable.|||||
776497|NCT00766597|Secondary|Number of Participants With Changes in Co-receptor Tropism From Baseline|Among all patients enrolled in Step I, the prevalence of detectable coreceptor phenotype, R5 tropic, R5/X4 mixed and X4 tropic viruses will be evaluated. The extent to which coreceptor phenotype in Step I is associated with Step I CD4 cell count, HIV RNA, and age will be evaluated. The association of Step I coreceptor phenotype and nadir CD4, HIV subtype, number of ART regimens, and years of ART will be evaluated. At the time of virologic failure, the extent of change from Step I and/or baseline R5 tropic virus to R5/X4 mixed or to X4 tropic virus as detected by the TrofileTM assay will be evaluated.|At Baseline, Week 24|HIV-1 infected ART-experienced participants with CCR5-tropic virus who started treatment in Step II and have reached Week 24. Measure was not analyzed since only one participant reached Week 24, no aggregate results were available for posting, and the individual participant-level data were not posted due to being potentially identifiable.|||||
776498|NCT00766597|Secondary|Number of Participants Who Failed to Achieve =>1-log Drop From Baseline in HIV-1 Viral Load and HIV-1 Viral Load of =>400 Copies/mL (Virologic Failures)|Plasma HIV RNA (RNA) concentrations were determined at entry and at regular intervals using the HIV-1 MONITOR Test, version 1.5 (Roche Molecular Diagnostics) or RealTime HIV-1 (Abbott Molecular). The primary definition of virologic success will require subjects to have achieved and maintained 1-log drops from baseline of HIV-1 RNA or HIV-1 RNA <400 copies/mL.|At Baseline, Week 24|HIV-1 infected ART-experienced participants with CCR5-tropic virus who started treatment in Step II and have reached Week 24. Measure was not analyzed since only one participant reached Week 24, no aggregate results were available for posting, and the individual participant-level data were not posted due to being potentially identifiable.|||||
776499|NCT00766597|Primary|Number of Participants Who Failed to Meet PK Targets|For Stage I subjects who are enrolled in Step II, the average of the pre-dose and 24 hour post dose sample from the intensive PK evaluations of said subjects will be used as the estimate of Cmin. The whole cohort will fail the PK targets if the population target (median vicriviroc Cmin should be =>200 ng/mL) is not met, and that nearly all of subjects’ Cmin failed to be > 100 ng/mL.|At Week 24|The HIV-1 infected antiretroviral therapy experienced participants with CCR-5 tropic virus who started treatment in Step II and who failed the PK targets. Outcome measure not analyzed since the PK targets were for the whole cohort, but the lone cohort opened was not fully enrolled due to early study termination.|||||
776500|NCT00766597|Primary|Number of Participants With Adverse Events of Grade 3 or Higher Severity|Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004, Clarification August 2009, which is available on the RCC website at (http://rcc.tech-res.com/). All grade 3 and higher signs, symptoms, and laboratory toxicities were included.|From study entry to Week 24 or the early study termination whichever occurred earlier|The HIV-1 infected antiretroviral therapy experienced participants with CCR-5 tropic virus who started treatment in Step II||participants|||Number
776501|NCT00766597|Primary|Number of Participants With Suspected Adverse Drug Reaction Leading to Treatment Termination|The protocol required reporting of signs and symptoms and laboratory abnormalities of >=Grade 2 and all grades of fever. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.The attribution of relationship of serious adverse events to study drug for the purposes of employing the start, stop and pause rules is to be determined by the Study Team. Gradation of relationship will use the following terminology: Not related, Probably not related, Possibly related, Probably related or Definitely related.|From study entry to Week 24 or the early study termination whichever occurred earlier|The HIV-1 infected antiretroviral therapy experienced participants with CCR5-tropic virus who started treatment in Step II.||participants|||Number
776502|NCT00766636|Primary|Difference in Positive Margin Resection (R1) Rate in Patients Undergo Surgery Between the Two Treatment Groups.|Difference in positive margin resection (R1) rate in patients who undergo surgery between the two treatment groups. Margin resection rate is defined as number of patients with R1 margin divided by the total number of patients who received surgery in that arm. Eligible patients will be equally (1:1 ratio) randomized to one of the two arms to receive either Gemcitabine and Erlotinib or Gemcitabine and Erlotinib and radiation as preoperative therapy. Surgery to be performed approximately 4 weeks after preoperative therapy. R1 resection defined as as tumor within 2mm of the surgical margin on the final pathology report|Following resection performed at time of surgery, day 36 of treatment +/- 5 days|The study was terminated early without enough patients to perform any analysis between the groups. Of the five registered, one withdrew prior to any treatment and the others either had disease progression or left prior to surgery with incomplete preoperative regimen.|||||
776503|NCT00766649|Secondary|Change in Photoreceptor Outer Segment (PROS) Thickness as Measured by Optical Coherence Tomography at 24 Months as Compared to Baseline||Baseline and Month 24||||||
776504|NCT00766649|Secondary|Change in Drusen Volume as Measured by Optical Coherence Tomography (OCT) at 24 Months as Compared to Baseline||Baseline and Month 24||||||
776505|NCT00766649|Secondary|Change in Total Area of Drusen in the Fellow Eye at 24 Months as Compared to Baseline|"The total area occupied by drusen was determined using planimetry for color stereoscopic fundus images by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).
One Macular Photocoagulation Study Disc Area (MPS DA) is equivalent to 1.77 mm^2 on the retina."|Baseline and Month 24|||MPS DA|Participants|Standard Deviation|Mean
776506|NCT00766649|Secondary|Change in Total Area of Drusen in the Study Eye at 24 Months as Compared to Baseline|"The total area occupied by drusen was determined using planimetry for color stereoscopic fundus images by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).
One Macular Photocoagulation Study Disc Area (MPS DA) is equivalent to 1.77 mm^2 on the retina."|Baseline and Month 24|||MPS DA|Participants|Standard Deviation|Mean
776507|NCT00766649|Primary|Rate of Change in Area of Geographic Atrophy (GA) in the Fellow Eye at 24 Months as Compared to Baseline|One Macular Photocoagulation Study Disc Area (MPS DA) is equivalent to 1.77 mm^2 on the retina.|Baseline and Month 24|||MPS DA/month||Standard Deviation|Mean
776508|NCT00766649|Primary|Rate of Change in Area of Geographic Atrophy (GA) in the Study Eye at 24 Months as Compared to Baseline|One Macular Photocoagulation Study Disc Area (MPS DA) is equivalent to 1.77 mm^2 on the retina.|Baseline and Month 24|||MPS DA/month||Standard Deviation|Mean
776509|NCT00766649|Secondary|Relative Change in Total Area of Geographic Atrophy (GA) in the Fellow Eye at 24 Months as Compared to Baseline|"Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for color stereoscopic fundus images by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).
This outcome measure was calculated by dividing the absolute change in the total area of GA in the fellow eye at 24 months by the baseline value.
One Macular Photocoagulation Study Disc Area (MPS DA) is equivalent to 1.77 mm^2 on the retina. As the unit of measure for both the absolute change in the total area of GA and the baseline value for the total area of GA is MPS DA, the unit of measure for the relative change in the total area of GA is ratio."|Baseline and Month 24|||Ratio|Participants|Standard Deviation|Mean
776510|NCT00766649|Secondary|Relative Change in Total Area of Geographic Atrophy (GA) in the Study Eye at 24 Months as Compared to Baseline|"Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for color stereoscopic fundus images by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).
This outcome measure was calculated by dividing the absolute change in the total area of GA in the study eye at 24 months by the baseline value.
One Macular Photocoagulation Study Disc Area (MPS DA) is equivalent to 1.77 mm^2 on the retina. As the unit of measure for both the absolute change in the total area of GA and the baseline value for the total area of GA is MPS DA, the unit of measure for the relative change in the total area of GA is ratio."|Baseline to Month 24|||Ratio|Participants|Standard Deviation|Mean
776511|NCT00766649|Secondary|Absolute Change in Total Area of Geographic Atrophy (GA) in the Fellow Eye at 24 Months as Compared to Baseline|"Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for color stereoscopic fundus images by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).
This outcome measure was calculated by subtracting the GA value for the fellow eye at baseline from the GA value for the study eye at Month 24.
One Macular Photocoagulation Study Disc Area (MPS DA) is equivalent to 1.77 mm^2 on the retina."|Baseline and Month 24|||MPS DA|Participants|Standard Deviation|Mean
776512|NCT00766649|Secondary|Absolute Change in Total Area of Geographic Atrophy (GA) in the Study Eye at 24 Months as Compared to Baseline|"Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for color stereoscopic fundus images by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).
This outcome measure was calculated by subtracting the GA value for the study eye at baseline from the GA value for the study eye at Month 24.
One Macular Photocoagulation Study Disc Area (MPS DA) is equivalent to 1.77 mm^2 on the retina."|Baseline and Month 24|||MPS DA|Participants|Standard Deviation|Mean
776513|NCT00766649|Secondary|Number of Study Eyes With a 15 Letter Drop From Baseline at 24 Months|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Month 24|||eyes|Participants||Number
776514|NCT00766675|Secondary|Number of Participants With Subject's Global Assessment|Participants indicated their condition on Day 1 before the start of treatment and each return visit. The assessment included how the drug controlled the pain (Question 1 [Q1]), adverse event (Question 2 [Q2]), and overall evaluation (Question 3 [Q3]), and participants indicated their condition as very good, good, moderate, poor and very poor.|Day 14, 28 and 56|The ITT population included all enrolled participants.||Participants|||Number
776515|NCT00766675|Secondary|Number of Participants With Physician Global Assessment|The treating physician rated the participant's condition on Day 1 before the start of treatment and each return visit. The assessment included how the drug controlled the pain (Question 1 [Q1]), adverse event (Question 2 [Q2]), and overall evaluation (Question 3 [Q3]), and participant's condition was indicated as very good, good, moderate, poor and very poor.|Day 14, 28 and 56|The ITT population included all enrolled participants.||Participants|||Number
776516|NCT00766675|Secondary|Total Fibromyalgia Impact Questionnaire (FIQ) Score|The FIQ was 19-item questionnaire which measured participant status, progress and outcomes. First 10 items made up of a physical functioning scale, ranging from 0 (always) to 3 (never). Items 11 and 12 asked participants to mark the number of days they felt well (0-7 days) and missed work (0-5 days). Items 13-19 were measured using 10 centimeter (cm) visual analog scale, score ranging from 0 cm (no) to 10 cm (very). Total FIQ score ranged from 0 -100 which was calculated as sum of final scores for item 1-10, 11 and 12, and individual score for item 13-19, and higher score indicates worsening.|Baseline and Day 56|"The ITT population included all enrolled participants. 'N' (number of participants analyzed) signifies the participants evaluable for this measure and n signifies those participants who were evaluated for this measure at the specified time point."||Units on a scale||Standard Deviation|Mean
776529|NCT00766831|Secondary|Percentage of Participants Who Preferred the Oral Long-Action Opioids Analgesic or Study Drug|Participant's preferences between the oral long-action opioids analgesic and the study drug was reported.|Day 15|ITT population included all the participants who received at least one dose of study medicaation and had the data on sleep disturbance caused by pain at Day 15. Last observation carried forward (LOCF) was used.||Percentage of participants|||Number
776517|NCT00766675|Secondary|Participant Assessment Sleep Questionnaire Score|Sleep questionnaire consisted of 12-Questions (Q), Q3-Q12 were related to “How often during past 4 weeks did participant felt” and are as: Q3: sleep not quiet, Q4: get enough sleep to feel rested upon waking in morning, Q5: awaken short of breath or with headache, Q6: feel drowsy or sleepy, Q7: have trouble falling asleep, Q8: awaken during sleep time and have trouble falling asleep again, Q9: trouble staying awake during day, Q10: snore, Q11: take naps during day, Q12: get amount of sleep needed. Score ranged from 1= all the time to 6 = none of the time, higher score indicates improvement.|Baseline and Day 56|The ITT population included all enrolled participants. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.||Units on a scale||Standard Deviation|Mean
776518|NCT00766675|Secondary|Sleep Questionnaire: Number of Hours to Fall Asleep and Participant Slept|The patient assessment sleep questionnaire consisted of 12-Questions (Q) to evaluate the participant’s sleep habits out of which Q1 was “How long did it usually take for participant to fall asleep during the past 4 weeks” and Q2 was “On the average, how many hours did participant sleep each night during the past 4 weeks”.|Baseline and Day 56|The ITT population included all enrolled participants. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.||Hours||Standard Deviation|Mean
776519|NCT00766675|Secondary|Tender-Point Evaluation/ Myalgic Score|Eighteen tender-point sites were evaluated by digital palpation for pain by the same Investigator at each site. The Investigator rated the participant's response to digital palpation on a scale from 0 (no pain [participant did not have a tender point]) to 3 (participant withdrawn or flinched). Total myalgic score was the sum of tender-point pain ratings.The total tender-Point score ranges from 0 to 18, and the total myalgic score ranges from 0 to 54. Higher score indicates worsening.|Baseline and Day 56|The ITT population included all enrolled participants. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.||Units on a scale||Standard Deviation|Mean
776520|NCT00766675|Secondary|Number of Participants With Categorical Scores on Pain Relief Rating Scale|Pain Relief Rating Scale was used to measure the amount of pain relief experienced (on average) relative to the no-medication Screening or wash-out phase using a 6-point Likert scale ranging from (-) 1 to 4 and rated as (-) 1=worse, 0=None, 1=Slight, 2=moderate,3=a lot and 4=complete.|Day 14, 28 and 56|The ITT population included all enrolled participants.||Participants|||Number
776521|NCT00766675|Primary|Pain Visual Analog Scale Score at Day 56|"Pain visual analog scale was used to assess the amount of pain recently experienced (within the last 48 hours) by marking a slash through the line of a 100 millimeter (mm) scale measuring pain from no pain (0 mm) to worst possible pain (100 mm)."|Day 56|The ITT population included all enrolled participants. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.||Millimeter (mm)||Standard Deviation|Mean
776522|NCT00766675|Primary|Pain Visual Analog Scale Score at Day 28|"Pain visual analog scale was used to assess the amount of pain recently experienced (within the last 48 hours) by marking a slash through the line of a 100 millimeter (mm) scale measuring pain from no pain (0 mm) to worst possible pain (100 mm)."|Day 28|The ITT population included all enrolled participants. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.||Millimeter (mm)||Standard Deviation|Mean
776523|NCT00766675|Primary|Pain Visual Analog Scale Score at Day 14|"Pain visual analog scale was used to assess the amount of pain recently experienced (within the last 48 hours) by marking a slash through the line of a 100 millimeter (mm) scale measuring pain from no pain (0 mm) to worst possible pain (100 mm)."|Day 14|Intent to treat (ITT) population included all enrolled participants. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.||Millimeter (mm)||Standard Deviation|Mean
776524|NCT00766753|Secondary|Overall Survival (OS)|Time interval from start of treatment until date of death.|Up to 102 months|Patients with recurrent malignant glioma treated with novel vaccination with type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for (GAA) epitopes and administration of polyinosinic-polycytidylic acid [poly(I:C)] stabilized by lysine and arboxymethylcellulose (poly-ICLC) who received at least one vaccine up to 4 vaccines||months||90% Confidence Interval|Median
776525|NCT00766753|Secondary|12-month- Progression Free Survival (PFS)|Number of patients with progression-free status lasting at least 12 months|Up to 12 months|Patients with recurrent malignant glioma treated with novel vaccination with type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for (GAA) epitopes and administration of polyinosinic-polycytidylic acid [poly(I:C)] stabilized by lysine and arboxymethylcellulose (poly-ICLC) who received at least one vaccine up to 4 vaccines||participants|||Number
776526|NCT00766753|Primary|Median Time To Progression|Median number of months until disease progression. Tumor size was assessed using magnetic resonance imaging (MRI) scans with contrast enhancement to detect change from baseline.|At baseline, 9, 17, 25, and 33 weeks, and every 3 months; up to 23 months|Patients with recurrent malignant glioma treated with novel vaccination with type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for (GAA) epitopes and administration of polyinosinic-polycytidylic acid [poly(I:C)] stabilized by lysine and arboxymethylcellulose (poly-ICLC) who received at least one vaccine up to 4 vaccines||months||Full Range|Median
776527|NCT00766753|Primary|Number of Participants Who Experienced Treatment-related Dose Limiting Toxicities (DLT)|Number of participants who experienced treatment-related Dose Limiting Toxicities (DLT) at any dose level.|up to 8 weeks|Participants at any dose level, through the first booster phase.||Participants|||Count of Participants
776528|NCT00766831|Secondary|Percentage of Participants With Different Reasons for Their Preference for Oral Long-Action Opioids Analgesic or Study Drug|"Participants reasons for preference between the long acting oral opioid analgesic and the study drug administered were reported. Reasonos for preferences were I experienced a certain pain relief effect during the administration of the drug, I didn’t wake up due to pain while sleeping, It was more convenient because the number of administrations was reduced, I could reduce the administration of short acting narcotic analgesic to treat breakthrough pain and other."|Day 15|ITT population included all the participants who received at least 1 dose of study medication and had the data on sleep disturbance caused by pain at Day 15. LOCF was used.||Percentage of participants|||Number
776541|NCT00767000|Primary|Percentage of Participants Who Discontinued Study Medication Due to an Adverse Event||Entire study including 54-week study and 104-week extension|||percentage of participants|||Number
776530|NCT00766831|Secondary|Number of Participants in Each Category of Global Assessment of Overall Efficacy of Study Drug Assessed by Investigators|Investigator evaluated overall efficacy of study drug according to the rating of 1=not effective, 2=average, 3=effective, 4=very effective and 5=extremely effective.|Day 15|ITT population included all the participants who received at least 1 dose of study medication and had the data on sleep disturbance caused by pain at Day 15. LOCF was used.||Participants|||Number
776531|NCT00766831|Secondary|Number of Participants in Each Category of Global Assessment of Overall Efficacy of Study Drug Assessed by Participants|Participants evaluated overall efficacy of study drug according to the rating of 1=not effective, 2=average, 3=effective, 4=very effective and 5=extremely effective.|Day 15|ITT population included all the participants who received at least one dose of study medication and had the data on sleep disturbance caused by pain at Day 15. LOCF was used.||Participants|||Number
776532|NCT00766831|Secondary|Number of Participants With Clinical Global Impression-Improvement (CGI-Improvement) Score|The CGI-Improvement score evaluates how much the participant’s condition is improved compared to Baseline. The score ranges from 1 to 7, where 1=improved very much, 2=Improved much, 3=Improved a little, 4=No change, 5=Aggravated a little,6=Aggravated much and 7=aggravated very much.|Day 15|ITT population included all the participants who received at least 1 dose of study medication and had the data on sleep disturbance caused by pain at Day 15. LOCF was used.||Participants|||Number
776533|NCT00766831|Secondary|Number of Participants With Each Grade of Eastern Cooperative Oncology Group (ECOG) Performance Status Score|The ECOG performance status was used to evaluate participant’s disease progression and the effect of the disease on the participant’s activities of daily living. ECOG performance status score ranges from Grade 0 to 4, where Grade 0=Fully active, Grade 1=restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, Grade 2=ambulatory and capable of all self-care but unable to carry out any work activities, Grade 3=capable of only limited self-care, confined to bed or chair, and Grade 4=completely disabled.|Baseline and Day 15|ITT population included all the participants who received at least 1 dose of study medication and had the data on sleep disturbance caused by pain at Day 15. LOCF was used.||Participants|||Number
776534|NCT00766831|Secondary|Number of Times the Short-Acting Opioid Analgesic Administered for Breakthrough Pain|The participants recorded the frequency of short acting opioid analgesic taken for treating breakthrough pain among the pains suffered by the participants. Here frequency means number of times the short-acting opioid analgesic administered for breakthrough pain from baseline to Day 15|Baseline and Day 15|ITT population included all the participants who received at least 1 dose of study medication and had the data on sleep disturbance caused by pain at Day 15. LOCF was used. Here 'N' signifies participants who were evaluated for this outcome measure.||Frequency of breakthrough pain drug||Standard Deviation|Mean
776535|NCT00766831|Secondary|Participant’s Pain Intensity|Participant’s pain intensity was measured using NRS ranging from 0=no pain to 10=unimaginable extreme pain. Participants maintained pain diary for 3 days before Baseline until Day 15 and pain intensity was measured twice daily (morning and afternoon). Here average pain intensity is reported. Average pain intensity was calculated as mean of morning pain intensity and evening pain intensity for each baseline and Day 15.|Baseline and Day 15|ITT population included all the participants who received at least 1 dose of study medication and had the data on sleep disturbance caused by pain at Day 15. LOCF was used.||Units on a scale||Standard Deviation|Mean
776536|NCT00766831|Secondary|Korean Brief Pain Inventory (K-BPI) Questionnaire Score|K-BPI is a questionnaire designed to measure the degree of pain severity and the impact of pain in performing daily routines. K-BPI comprises of 9 items out of which 6 items were assessed. Score of each item ranges from 0 to 10, where 0=no pain/impact and 10=severe pain/impact. The 6 items that were assessed are: a) level of pain worst in last 24 hours; b) level of pain weakest in last 24 hours; c) level of pain average in last 24 hours; d) level of pain right now; e) how much pain reduced with the therapy taken; sixth item was further classified into 7 categories: i) general activities ii) mood iii) ambulatory ability iv) routine works v) interpersonal relation vi) sleep vii) life enjoyment.|Baseline and Day 15|ITT population included all the participants who received at least 1 dose of study medication and had the data on sleep disturbance caused by pain at Day 15. LOCF was used. Here 'n' signifies the number of participant who were evaluated for particular category at particular time point.||Units on a scale||Standard Deviation|Mean
776537|NCT00766831|Secondary|Sleep Disturbance Questionnaire: Wake up Due to Unbearable Pain|"The Investigator evaluated sleep disturbance through the participant’s answers to below question in yes or no response: ‘Did you wake up because of unbearable pain this morning?’"|Baseline and Day 15|ITT population included all the participants who received at least 1 dose of study medication and had the data on sleep disturbance caused by pain at Day 15. LOCF was used.||Participants|||Number
776538|NCT00766831|Secondary|Sleep Disturbance Questionnaire: Frequency of Waking Up|The Investigator evaluated sleep disturbance through the participant’s answers to below question: How many times did you wake up while sleeping late night (frequency [once, 2 times, 3 times, 4 times, 5 times, couldn’t fall asleep at all] of waking up due to pain last night).|Baseline and Day 15|ITT population included all the participants who received at least 1 dose of study medication and had the data on sleep disturbance caused by pain at Day 15. LOCF was used. Here 'n' signifies participants who were evaluated for this outcome measure at a particular time point.||Participants|||Number
776539|NCT00766831|Secondary|Sleep Disturbance Questionnaire: Analgesic Administration|"The Investigator evaluated sleep disturbance through the participant’s answers to below question in yes or no response: ‘Did you need to take an analgesic for pain relief in order to go to sleep last night?’"|Baseline and Day 15|ITT population included all the participants who received at least 1 dose of study medication and had the data on sleep disturbance caused by pain at Day 15. LOCF was used.||Participants|||Number
776540|NCT00766831|Primary|Percentage of Treatment Response in Sleep Disturbance Caused by Cancer Pain|Percentage of treatment response in sleep disturbance caused by cancer pain was reported. Treatment response in sleep disturbance was measured by Numeric Rating Scale (NRS) ranging from 0=no disturbance to 10=extreme disturbance.|Day 15 or Early withdrawal|Intent to treat (ITT) population included all the participants who received study medication at least 1 dose of study medication and had the data on sleep disturbance caused by pain at Day 15. Last observation carried forward (LOCF) was used.||Percentage of treatment response||95% Confidence Interval|Number
776545|NCT00767000|Secondary|Change in the Fasting Plasma Glucose Level|Least squares mean change from baseline in fasting plasma glucose.|Baseline and Weeks 14, 54, 106, and 158|Full analysis set. The additional participants added to the MK-0941 40 mg and placebo arms to enhance evaluation of safety were not included in the analysis.||mg/dL||95% Confidence Interval|Least Squares Mean
776546|NCT00767000|Secondary|Change in the Two-hour Post Meal Glucose Level|Least squares mean change from baseline in 2-hour post meal glucose level.|Baseline and Weeks 14, 54, 106, and 158|Full analysis set. The additional participants added to the MK-0941 40 mg and placebo arms to enhance evaluation of safety were not included in the analysis.||mg/dL||95% Confidence Interval|Least Squares Mean
776547|NCT00767000|Primary|Change in Hemoglobin A1c (HbA1c) Level|Least square means change from baseline in HbA1c. HbA1c represents the percentage of glycated hemoglobin. A negative number means reduction in HbA1c level.|Baseline and Weeks 14, 54, 106, and 158|Full analysis set. The additional participants added to the MK-0941 40 mg and placebo arms to enhance evaluation of safety were not included in the analysis.||Percent HbA1c||95% Confidence Interval|Least Squares Mean
776548|NCT00767039|Secondary|Bronchopulmonary Dysplasia (Supplemental Oxygen at 36 Week Post Menstrual Age) or Death Before Discharge From NICU.|Bronchopulmonary Dysplasia + death outcome for all patients enrolled in the study were tallied and used to determine whether neonatal death decreased the frequency of chronic lung disease in one group vs the other.|NICU hospitalization, up to 42 weeks post menstrual age|All subjects enrolled were included. Subjects with Bronchopulmonary Dysplasia (continuous supplemental oxygen need at > 36 weeks post menstrual age) and patients who expired before discharge from the NICU were tallied.||Subjects with BPD + Neonatal Deaths||90% Confidence Interval|Number
776549|NCT00767039|Secondary|Patients With Bronchopulmonary Dysplasia (Supplemental Oxygen at 36 Week Post Menstrual Age)|Patients with Bronchopulmonary Dysplasia (BPD), had chronic lung disease requiring supplemental oxygen support at >/= 36 weeks post menstrual age, were tallied. BPD is a chronic lung disease that develops, at least in part, as a consequence of NICU respiratory management of premature infants with Respiratory Distress Syndrome.|36 weeks post menstrual age|Population analyzed was limited to those subjects who survived to >36 weeks post menstrual age. Subjects with Bronchopulmonary Dysplasia (continuous supplemental oxygen need at >36 weeks post menstrual age) were tallied.||Surviving Subjects with BPD||90% Confidence Interval|Number
776550|NCT00767039|Secondary|Change in Anterior Cerebral Artery Blood Flow Velocity Following Second Dose of Surfactant|Percent change in Anterior Cerebral Artery blood flow velocity following the second dose of beractant, reflects the change in brain blood flow associated with surfactant administration. Blood flow velocity is measured by range gated Doppler ultrasound and brain blood flow changes in proportion to changes in arterial carbon dioxide levels, induced by surfactant administration. Variability in brain blood flow is associated with increased risk for intraventricular hemorrhage.|One hour following second surfactant dose at 12-24 hours after initial dose|The population analyzed was limited to subjects that received second dose of surfactant and were clinically stable enough to allow Doppler assessment of cerebral blood flow during the first hour following surfactant administration.||Percent change from baseline velocity||Standard Error|Mean
776551|NCT00767039|Primary|Comparison Respiratory Support (Mean Airway Pressure x Percent Fraction of Inspired Oxygen) for Survanta (Beractant) and Curosurf (Poractant) at 72 Hours After Surfactant Administration.|Mean Airway Pressure x Percent Fraction of Inspired Oxygen (FIO2) at 72 hours after surfactant administration, delivered by mechanical ventilator or nasal CPAP assesses the components of respiratory support primarily affecting blood oxygenation. This index combines these parameters so that a systematic difference in clinical management of mean airway pressure or FIO2 between groups is not mistaken for a drug effect.|72 hours after surfactant administration|Enrolled subjects surviving >/= 3 days were included in the analysis. Two subjects in the Survanta (beractant) groups died in this period and were eliminated from this portion of the analysis.||cm H20-Percent of O2||Standard Error|Mean
776552|NCT00767039|Primary|Comparison Respiratory Support (Mean Airway Pressure x Percent Fraction of Inspired Oxygen) for Survanta (Beractant) and Curosurf (Poractant) at 48 Hours After Surfactant Administration.|Mean Airway Pressure x Percent Fraction of Inspired Oxygen (FIO2) at 48 hours after surfactant administration, delivered by mechanical ventilator or nasal CPAP assesses the components of respiratory support primarily affecting blood oxygenation. This index combines these parameters so that a systematic difference in clinical management of mean airway pressure or FIO2 between groups is not mistaken for a drug effect.|48 hours after surfactant administration|Enrolled subjects surviving >/= 3 days were included in the analysis. Two subjects in the Survanta (beractant) groups died in this period and were eliminated from this portion of the analysis.||cm H20-Percent of O2||Standard Error|Mean
776553|NCT00767039|Secondary|Changes in Blood Flow Through the Patent Ductus Arteriosus (PDA) Following Second Dose of Survanta (Beractant) and Poractant Alfa (Curosurf)|Maximal changes in blood flow were assessed using Doppler echocardiography following the second surfactant dose of Survanta (beractant) or Curosurf (poractant alfa), to determine whether there was a direct effect of surfactant type on PDA size or pulmonary volume overload through the PDA. The hour interval following the second surfactant dose was selected for study, when the subjects were otherwise clinically stable, not needing additional stabilization procedures.|First hour after 2nd surfactant dose|Population was limited to those subjects with PDA's who were treated with a second dose of surfactant, when the subjects were hemodynamically stable enough to yield meaning data.||cc/min||Standard Error|Mean
776554|NCT00767039|Secondary|Comparison of Hemodynamically Significant Patent Ductus Arteriosus (PDA) in Patients Treated With Curosurf (Poractant) and Survanta (Beractant)|Hemodynamically significant PDA, considered significant by the clinical team and having at least 2 objective echocardiographic signs (PDA > 1.5 mm diameter, retrograde diastolic flow in the descending aorta, and left atrial enlargement) were tallied. Hemodynamically significant PDA may increase lung water and decrease lung compliance, requiring increased mechanical ventilator support.|Hemodynamically significant PDA at > 2 days|Patients with clinically and hemodynamically significant Patent Ductus Arteriosus, on evaluation at >3 days, were tallied||Subjects||90% Confidence Interval|Number
776577|NCT00767520|Secondary|Number of Participants With Abnormalities in Electrocardiograms||Data was collected prior treatment with the study drug, after week 2, 4, and week 8, every 8 weeks thereafter and at the end of the treatment.||05/2013||||
776578|NCT00767520|Secondary|Number of Participants With Abnormalities in Vital Signs||Data was collected prior treatment with the study drug, after week 2, 4, and week 8, every 8 weeks thereafter and at the end of the treatment.||05/2013||||
776555|NCT00767039|Secondary|Comparison of Infants Successfully Extubated at 72 Hours for Curosurf (Poractant) and Survanta (Beractant) Groups|Subjects successfully extubated and no longer needing positive pressure endotracheal mechanical ventilation at 72 hours after surfactant administration helps to explain the difference in mean airway pressure observed between groups.|72 hours after surfactant administration|Patients no longer needing positive pressure endotracheal mechanical ventilation were tallied to help explain the between group differences in mean airway pressure.||Participants successfully extubated||90% Confidence Interval|Number
776556|NCT00767039|Primary|Comparison of Respiratory Support (Mean Airway Pressure) for Curosurf (Poractant) and Survanta (Beractant) 72 Hours After Surfactant Administration|Mean Airway Pressure delivered by mechanical ventilator or nasal CPAP (cm H20) at 72 hours following surfactant administration. A volume cycle ventilator strategy that allowed airway pressure to vary with changes in lung and chest wall compliance was used for mechanically ventilated infants, while oxygen concentration was controlled by the clinical team.|72 hours after surfactant administration|Enrolled subjects surviving >/= 3 days were included in the analysis. Two subjects in the Survanta (beractant) groups died in this period and were eliminated from this portion of the analysis.||cm H20||Standard Error|Mean
776557|NCT00767039|Secondary|Comparison of Infants Successfully Extubated at 48 Hours for Curosurf (Poractant) and Survanta (Beractant) Groups|Subjects successfully extubated and no longer needing positive pressure endotracheal mechanical ventilation at 48 hours after surfactant administration helps to explain the difference in mean airway pressure observed between groups.|48 hours after surfactant administration|Patients no longer needing positive pressure endotracheal mechanical ventilation were tallied to help explain the between group differences in mean airway pressure.||Participants successfully extubated||90% Confidence Interval|Number
776558|NCT00767039|Primary|Comparison Respiratory Support (Mean Airway Pressure) for Survanta (Beractant) and Curosurf (Poractant) at 48 Hours After Surfactant Administration.|Mean Airway Pressure delivered by mechanical ventilator or nasal CPAP (cm H20) at 48 hours following surfactant administration. A volume cycle ventilator strategy that allowed airway pressure to vary with changes in lung and chest wall compliance was used for mechanically ventilated infants, while inspired oxygen concentration was controlled by the clinical team.|48 hours after surfactant administration|Enrolled subjects surviving >/= 3 days were included in the analysis. Two subjects in the Survanta (beractant) groups died in this period and were eliminated from this portion of the analysis.||cm H20||Standard Error|Mean
776559|NCT00767104|Secondary|% Reduction in Total Lesion Count|.This is a measure of the % reduction in the total number of papules, pustules and cysts at Week 12.|12 weeks|||% reduction in total lesion count||95% Confidence Interval|Mean
776560|NCT00767104|Primary|Total Lesion Count|The number of papules, pustules and cysts at Week 12.|12 weeks|Number of participants in each group||lesions||95% Confidence Interval|Mean
776561|NCT00767325|Secondary|Number of Participants With Adverse Events (AEs) of Interest|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Infusion reaction: acute=1 hour or less after start of dosing; periinfusional=24 hours or less after start of dosing.|Days 1 to 169 to 56 days following last infusion|All participants who received at least 1 infusion of study drug.||Participants|||Number
776562|NCT00767325|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events(SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, Discontinuations Due to AEs|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug.|Days 1 to 169 to 56 days following last infusion|All participants who received at least 1 infusion of study drug.||Participants|||Number
776563|NCT00767325|Secondary|Number of Early (Days 7 to 113) Global PDUS MCP 2-5 Scores or Global PDUS Component MCP 2-5 Scores Associated With an Acceptable Predictability of Clinical Response at Day 169, As Assessed by DAS28-CRP|MCP=metacarpophalangeal; PDUS=power Doppler ultrasonography; DAS=Disease Activity Score;CRP=C-reactive protein. Receiver Operator Characteristics (ROC) analysis assessed predicatability. ROC curve analyses performed; area under the curve of ≥0.7 was considered acceptable for prediction. Clinical response defined as: Clinically Meaningful Improvement=drop from baseline of ≥1.2 in DAS28-CRP; Remission=DAS28-CRP score <2.6; Low Disease Activity=≤3.2. PDUS scores: Grade (Gr) 0 or normal=normal joint (no synovial hypertrophy [SH], no Doppler signal); Gr 1 or minimal=minimal synovitis (minimal SH, with ≤Gr 1 Doppler signal); Gr 2 or moderate=moderate synovitis (moderate SH with ≤Gr 2 Doppler signal or minimal SH and Gr 2 Doppler signal); Gr 3 or severe=severe synovitis (severe SH with ≤Gr 3 Doppler signal or minimal or moderate SH and Gr 3 Doppler signal). Each joint rated 1-3, for a total possible score ranging from 8-24 (8*1, 8*3)for the 2 hands. Higher gr/score=more severe disease.|Days 1 to 169|All participants who received at least 1 infusion of study drug and who had baseline and at least 1 postbaseline efficacy measurements available. Excludes 8 participants with PDUS values from 1 site that experienced technical and quality issues with PDUS scoring and compliance.||Scores|||Number
776564|NCT00767325|Primary|Earliest Time Point at Which Improvement of Core Component of the Global PDUS in the MCP (2-5) Joints of Both Hands Was Assessed|MCP=metacarpophalangeal; PDUS=power Doppler ultrasonography. Time point at which early signs of Global PDUS improvement were observed=earliest time point for which 0 was not included in the 95% confidence interval for the mean changes from baseline in Global PDUS (MCP 2-5) score at that and all later time points. Total PDUS scores are independent of the presence and grade of joint effusion: Grade (Gr) 0 or normal=normal joint (no synovial hypertrophy [SH], no Doppler signal); Gr 1 or minimal=minimal synovitis (minimal SH, with ≤Gr 1 Doppler signal); Gr 2 or moderate=moderate synovitis (moderate SH, with ≤Gr 2 Doppler signal or minimal SH and grade 2 Doppler signal); Gr 3 or severe=severe synovitis (severe SH with ≤Gr 3 Doppler signal or minimal or moderate SH and Gr 3 Doppler signal). Each joint is rated 1 to 3, for a total possible score ranging from 8 to 24 (8*1, 8*3) for the 2 hands. Higher Gr/score=more severe disease.|Baseline to Days 7, 15, 29, 43, 57, 85, 113, 141, and 169|All participants who received at least 1 infusion of study drug and who had baseline and at least 1 postbaseline efficacy measurements available. Excludes 8 participants with PDUS values from 1 site that experienced technical and quality issues with PDUS scoring and compliance.||Day|||Number
776565|NCT00767325|Secondary|Mean Change From Baseline in Global PDUS MCP 2-5 Component Scores Over Time (LOCF Analysis)|PDUS=power Doppler ultrasonography; MCP=metacarpophalangeal; LOCF=last observation carried forward. PDUS was used to assess the degree of synovial inflammation of the MCP joints (2nd to 5th) of both hands and was performed at approximately the same time of day for each participant. PDUS scores are independent of the presence and grade of joint effusion and are evaluated as follows: Grade 0 or normal=normal joint (no synovial hypertrophy, no Doppler signal); Grade 1 or minimal=minimal synovitis (minimal synovial hypertrophy, with ≤Grade 1 Doppler signal); Grade 2 or moderate=moderate synovitis (moderate synovial hypertrophy with ≤Grade 2 Doppler signal or minimal synovial hypertrophy and grade 2 Doppler signal); Grade 3 or severe=severe synovitis (severe synovial hypertrophy with ≤ Grade 3 Doppler signal or minimal or 1-3, for a total possible score ranging from 8 to 24 (8*1, 8*3) for the 2 hands. Higher grade/score=more severe disease. Change=score Day X-baseline score.|Days 7, 15, 29, and 169|All participants who received at least 1 infusion of study drug and who had baseline and at least 1 postbaseline efficacy measurements available. Excludes 8 participants with PDUS values from 1 site that experienced technical and quality issues with PDUS scoring and compliance.||Units on a scale||Standard Error|Mean
776566|NCT00767325|Primary|Mean Change From Baseline in Global Power Doppler Ultrasonography (PDUS) Score Assessing the Metacarpophalangeal (MCP) 2-5 Joints of Both Hands (LOCF Analysis)|LOCF=last observation carried forward. PDUS assessed the degree of synovial inflammation of the MCP joints (2nd to 5th) of both hands and was performed at approximately the same time of day for each participant. Total PDUS scores are independent of the presence and grade of joint effusion and are evaluated as follows: Grade 0 or normal=normal joint (no synovial hypertrophy, no Doppler signal); Grade 1 or minimal=minimal synovitis (minimal synovial hypertrophy, with ≤Grade 1 Doppler signal); Grade 2 or moderate=moderate synovitis (moderate synovial hypertrophy with ≤Grade 2 Doppler signal or minimal synovial hypertrophy and Grade 2 Doppler signal; Grade 3 or severe=severe synovitis (severe synovial hypertrophy with ≤Grade 3 Doppler signal or minimal or moderate synovial hypertrophy and Grade 3 Doppler signal). Each joint is rated 1 to 3, for a total possible score ranging from 8 to 24 (8*1, 8*3) for 2 hands. Higher grade/score=more severe disease. Change=score Day x - baseline score.|Baseline to Days 7, 15, 29, 43, 57, 85, 113, 141, and 169|All participants who received at least 1 infusion of study drug and who had baseline and at least 1 postbaseline efficacy measurements available. Excludes 8 participants with PDUS values from 1 site that experienced technical and quality issues with PDUS scoring and compliance.||Units on a scale||95% Confidence Interval|Mean
776567|NCT00767338|Primary|Number of Live Births After Eight Cycles of Infertility Treatment.||January 2009 to January 2012|The participants analyzed correspond to the number of participants who completed the study. In two of the arms, the study was terminated before participants were randomized to those arms.||participants|||Number
776568|NCT00767364|Secondary|Serum Anti-rotavirus IgA Level Post-vaccination|Serum anti-rotavirus IgA level was measured post-vaccination in all subjects|6 months from the first vaccination date|||U/ml|||Number
776569|NCT00767364|Primary|Safety and Tolerability of the Oral RotaTeq® Vaccine|Adverse events and patient tolerance of vaccine doses 1 - 3 for all infants participating in the study were recorded.|12 months from the first vaccination date|||Individual Adverse Events|||Number
776570|NCT00767455|Primary|Presence of Cumulative Irritation|Irritancy of each test article was evaluated by assessment of the application sites using the Berger and Bowman Scale. Observed responses (e.g., erythema and edema) were graded according to the protocol-specified grading scale [0 (no visible reaction) to 4 (severe erythema)] for each subject. The relative cumulative irritation potentials of the test article (HP828-101 Ointment) and the negative and positive controls were determined by summing the daily scores of the 21 days of testing; with an overall scale of 0 (no visible reaction from any subjects over the 21 days) to 3360 (severe erythema experienced by every subject over the 21 days).|22 days|Per protocol||units on a scale|||Number
776571|NCT00767507|Secondary|Patients With Blood Product Transfusions up to 7 Days After Surgery or Discharge, Whichever Was Sooner||Through 7 days or hospital discharge, whichever was sooner|||patients|||Number
776572|NCT00767507|Secondary|Non-CABG (Preoperative) Bleeding - Protocol-defined GUSTO Severe/Life-threatening, Moderate and Mild||Randomization until start of CABG surgery|This analysis included only those patients who proceeded to have a CABG surgery as required per the protocol. The patients who did not have a CABG surgery were excluded from the denominator.||participants|||Number
776573|NCT00767507|Secondary|Incidence of Excessive Coronary Artery Bypass Graft (CABG)-Related Bleeding|Defined as the occurrence of surgical re-exploration, 24-hour chest tube output of >1.5 liters (L), and/or packed red blood cell transfusions > 4 units|Randomization through Hospital discharge|This analysis included only those patients who proceeded to have a CABG surgery as required per the protocol. The patients who did not have a CABG surgery were excluded from the denominator.||Patients|||Number
776574|NCT00767507|Secondary|Stage II: Analysis of Platelet Reactivity (ITT Population) / Patients With Platelet Reactivity < 240 PRU|"This endpoint analyzed the percent of patients with platelet reactivity < 240 PRU at the following timepoints:
Baseline - Prior to study drug infusion (washout period from oral P2Y12 inhibition)
Last sample during infusion
Following discontinuation of study drug infusion"|baseline until just prior to surgery (post infusion)|||percent of patients|||Number
776575|NCT00767507|Primary|Stage II: The Percentage of Patients That Maintained Platelet Reaction Units (PRU) < 240, as Determined by the VerifyNow P2Y12 Point of Care Assay, Measured During Study Drug Infusion Pre-surgery.|"This endpoint was selected as it is considered by consensus of the Working Group on Platelet Reactivity to be the threshold for the level of platelet inhibition required to maintain a low risk of coronary thrombosis and cardiac ischemic events.
Patients had multiple samples and all on-infusion samples had to be <240 PRU to meet the endpoint."|During study drug infusion up to 1-6 hours prior to surgery|"Based on available data from ITT population; ITT population (Cangrelor N = 93) / (Placebo N = 90).
Valid PRU results were not available during the infusion period for 15 patients (9 cangrelor and 6 placebo)."||Percent of patients|||Number
776576|NCT00767507|Primary|Stage I: Percentage of Patient Samples That Maintained Platelet Inhibition Levels of Greater Than or Equal to 60% as Reported by the VerifyNow P2Y12 Point of Care Assay.|Endpoint was selected as an approximation of the antiplatelet effect expected to be maintained if oral P2Y12 inhibitors had not been discontinued (60% inhibition of platelets).|During study drug infusion up to 1-6 hours prior to surgery|||percentage of samples|Participants||Number
776579|NCT00767520|Secondary|Number of Participants With Grade 1-4 Serum Chemistry Abnormalities in Potassium, Magnesium, Sodium, Phosphorous, Uric Acid, and Bicarbonate (as Per the NCI CTCAE, Version 3.0)|Grade (GR)1= mild, GR2= moderate, GR3= severe, GR4= life threatening. Ranges are provided by the local laboratory and may vary according to sex and age. Phosphorous, GR1:<LLN 2.5 mg/dL, GR2:<2.5–2.0 mg/dL, GR3: 1.0-<2.0 mg/dL; Low sodium,GR1:<LLN 130mmol/L, GR3:120-<130 mmol/L; High Magnesium, GR1 >ULN 3.0 mg/dL,GR 3:<0.3 0.8mg/dL; Uric acid, GR1:>ULN 10 mg/dL, GR4:>10 mg/dL; Low potassium, GR1:<LLN 3.0mmol/L,GR3:<3.0 2.5mmol/L; High potassium, GR1:>ULN–5.5 mmol/L, GR2:>5.5–6.0 mmol/L; Bicarbonate, GR1:<LLN–16 mmol/L; GR2:<16 – 11 mmol/L; Hig sodium, GR1:>ULN–150 mmol/L,GR2:>150–155 mmol/L.|Data was collected prior treatment with the study drug, after week 2, 4, and week 8, every 8 weeks thereafter and at the end of the treatment. Median duration (on-study time) was 14.29 and 15.29 weeks for dasatinib and placebo groups, respectively.|All treated participants.||participants|||Number
776580|NCT00767520|Primary|Participants With Disease Progression or Death for Exemestane Plus Dasatinib vs Exemestane Plus Placebo|PD is an increase (≥ 20%) in sum of longest diameters from smallest value during study (including baseline).|Prior to study therapy, at 8 week intervals until progression occurs. Maximum participant PFS of ____ months)|All randomized participants. Participants who died without reporting tumor progression were considered to have progressed on the death date. Participants who neither progressed nor died were censored on the day of their last on-study tumor assessment or the first date of subsequent therapy.||participants|||Number
776581|NCT00767520|Secondary|Number of Participants With Grade 1-4 Serum Chemistry Abnormalities in Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Bilirubin, Calcium, Creatinine, and Albumin (as Per the NCI CTCAE, Version 3.0)|Grade (GR) 1 = mild, GR 2 = moderate, GR 3 = severe, GR 4 = life threatening). Normal ranges are provided by the Local Laboratory and may vary according to sex and age. Alanine aminotransferase, aspartate aminotransferase and alkaline phosphatase, GR 1: >ULN–2.5 x ULN (upper limit of normal), GR 2: >2.5–5.0 x ULN, GR 3: 5.0-20.0 x ULN; Low calcium, GR 1: <LLN – 8.0 mg/dL, GR 2: <8.0–7.0 mg/dL, GR 4:<6.0 mg/dL; High calcium, GR 1:>ULN – 11.5 mg/dL; bilirubin, GR 1: >ULN–1.5 x ULN,GR 3: >3-10 x ULN; Creatinine, GR1:>ULN–1.5 x ULN, GR2: >1.5–3.0 x ULN; Albumin, GR1:<LLN–3 g/dL,GR2:<3–2 g/dL.|Data was collected prior treatment with the study drug, after week 2, 4, and week 8, every 8 weeks thereafter and at the end of the treatment. Median duration (on-study time) was 14.29 and 15.29 weeks for dasatinib and placebo groups, respectively.|All treated participants.||participants|||Number
776582|NCT00767520|Secondary|Number of Participants With Grade 1-4 Hematology Abnormalities (as Per the NCI CTCAE, Version 3.0)|Abnormalities were graded per NCI-CTC, Version 3.0 criteria. Grade (GR)1 = mild, GR 2 = moderate, GR 3 = severe, GR 4 = life threatening. Normal ranges are provided by the Local Laboratory and may vary according to sex and age. Granulocytes, GR 1;<LLN–1.5x 10^9/L, GR 2:<1.5–1.0x10^9/L, GR 3: <1.0 – 0.5x10^9/L, GR, 4: <0.5x10^9 /L; Hemoglobin, GR 1: <LLN–10.0 g/dL, GR 2: <10.0–8.0 g/dL, GR 3: <8.0–6.5 g/dL, GR, 4: <6.5g/dL; Platelets, GR 1: <LLN–75.0x10^9/L, GR 2: <75.0–50.0x10^9/L, GR 3: <50.0-25.0x10^9/L; Leukocytes, GR 1: <LLN–3.0x10^9/L, GR 2: <3.0–2.0x10^9/L, GR 4: <1.0x10^9/L.|Data was collected prior treatment with the study drug, after week 2, 4, and week 8, every 8 weeks thereafter and at the end of the treatment. Median duration (on-study) was 14.29 and 15.29 weeks for dasatinib and placebo groups, respectively.|All treated participants.||participants|||Number
776583|NCT00767520|Secondary|Number of Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AEs (as Per National Cancer Institute [NCI] Common Toxicity Criteria for Adverse Events [CTCAE], Version 3.0)|AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to any AEs were recorded. Grade (GR)1 = mild, GR 2 = moderate, GR 3=severe, GR 4=life threatening, GR 5=death.|From start of study drug therapy up to 30 days after the last dose. Median duration of therapy (on-study time) was 14.29 and 15.29 weeks for dasatinib and placebo groups, respectively.|All treated participants.||participants|||Number
776584|NCT00767520|Secondary|Changes in Markers of Bone Lysis in Participants With Bone Metastasis|Assay for urinary N-telopeptide was used to evaluate Osteolytic activity.|Screening, Day 1, after week 2, 4, and week 8 and subsequently every 8 weeks, at end-of-treatment. Participants will remain on study (ie, last visit) until disease progression or 30 days after the last dose of study drug.||05/2013||||
776585|NCT00767520|Secondary|Changes in Participant-reported Pain Intensity in Participants With Bone Metastasis|Pain intensity evaluated by administration of the Brief Pain Inventory - Short Form (BPI-sf). The BPI-sf is a psychometrically-validated instrument which measures both pain severity and functional interference caused by pain using an 11-point numerical rating scale. Severity of pain at its “worst”, “least” and “on average” in the last 24 hours, and “right now” (ie, at the time the questionnaire is being filled out) is recorded using anchors of “no pain” = “0” and “pain as bad as you can imagine” = “10”.|Start of study, at treatment start, after 2, 4, and 8 weeks of therapy and every 8 weeks thereafter, at end-of-treatment. Participants will remain on study (ie, last visit) until disease progression or 30 days after the last dose of study drug.||05/2013||||
776586|NCT00767520|Secondary|Duration of Response for Exemestane Plus Dasatinib Arm and Exemestane Plus Placebo Arms|Duration of response is defined as the time from date that measurement criteria are first met for PR or CR until first date of documented PD or death. CR = Disappearance of all measurable and non-measurable lesions, and no new lesions; PR = Decrease ≥30% from baseline in sum of longest diameters of all measurable lesions, with neither appearance of new lesions nor unequivocal progression of non-measurable lesions. PD=Increase (≥ 20%) in sum of longest diameters from smallest value during study (including baseline).|Prior to study therapy, at 8 week intervals. Participants will remain on study (ie, last visit) until disease progression or 30 days after the last dose of study drug, whichever is longer.||05/2013||||
776599|NCT00767806|Secondary|Change From Baseline to 12 Week Endpoint in Pulse Rate|Least Squares Mean values were controlled for investigator.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.||beats per minute||Standard Error|Least Squares Mean
791687|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (White Blood Cell [WBC])||Baseline up to Month 7|||percentage of participants|||Number
776587|NCT00767520|Secondary|Time to Response for Exemestane Plus Dasatinib Arm and Exemestane Plus Placebo Arms|Time to response is defined as time from first dose of study therapy until measurement criteria are first met for PR or CR (whichever is recorded first). CR = Disappearance of all measurable and non-measurable lesions, and no new lesions; PR = Decrease ≥30% from baseline in sum of longest diameters of all measurable lesions, with neither appearance of new lesions nor unequivocal progression of non-measurable lesions.|Prior to study therapy, at 8 week intervals until CR or PR. Participants will remain on study (ie, last visit) until disease progression or 30 days after the last dose of study drug, whichever is longer||05/2013||||
776588|NCT00767520|Secondary|Participants With Freedom-From-Progression (FFP) at 6 Months|FFP at month 6 is defined for the randomized participants who had the probability of neither progressing nor dying before 6 months.|at 6 months||05/2013||||
776589|NCT00767520|Secondary|Percentage of Participants With Response in Exemestane Plus Dasatinib Arm and Exemestane Plus Placebo Arms|Response= Proportion of response-evaluable participants whose best response is CR or PR. Confidence intervals was computed using the Clopper-Pearson method. CR = Disappearance of all measurable and non-measurable lesions, and no new lesions; PR = Decrease ≥30% from baseline in sum of longest diameters of all measurable lesions, with neither appearance of new lesions nor unequivocal progression of non-measurable lesions.|Prior to study therapy, at 8 week intervals until progression occurs (maximum participant response was 39 weeks)|Response-evaluable participants: All treated participants who had measurable disease at baseline and at least one on-study tumor assessment. Treated participants without on-study tumor assessment due to rapid progression or study drug toxicity were included in the response-evaluable population as non-responders.||percentage of participants||95% Confidence Interval|Number
776590|NCT00767520|Secondary|Percentage of Participants With Clinical Benefit (CB) for Exemestane Plus Dasatinib Arm vs Exemestane Plus Placebo Arm at 6 Months|CB = participants whose best response is CR, PR, or stable disease(SD). CR = Disappearance of all measurable and non-measurable lesions, and no new lesions; PR = Decrease ≥30% from baseline in sum of longest diameters of all measurable lesions, with neither appearance of new lesions nor unequivocal progression of non-measurable lesions. SD = Disease re-assessment not qualifying as CR, PR or PD(≥20% increase in sum of longest diameters from smallest value). Confidence interval computed by Clopper-Pearson method.|at 6 months|Response-evaluable participants: All treated participants who had measurable disease at baseline and at least one on-study tumor assessment. Treated participants without on-study tumor assessment due to rapid progression or study drug toxicity were included in the response-evaluable population as non-responders.||percentage of participants||95% Confidence Interval|Number
776591|NCT00767520|Secondary|Number of Participants With Best Overall Response|Complete response (CR) = Disappearance of all measurable and non-measurable lesions, and no new lesions; Partial response (PR) = Decrease ≥30% from baseline in sum of longest diameters (LD) of all measurable lesions, with neither appearance of new lesions nor unequivocal progression of non-measurable lesions. SD = Disease re-assessment not qualifying as CR, PR or PD(≥20% increase in sum of longest diameters from smallest value).|at 6 months|Response-evaluable participants: All treated participants who had measurable disease at baseline and at least one on-study tumor assessment. Treated participants without on-study tumor assessment due to rapid progression or study drug toxicity were included in the response-evaluable population as non-responders.||participants|||Number
776592|NCT00767520|Primary|Progression Free Survival (PFS) Distribution for Exemestane Plus Dasatinib vs Exemestane Plus Placebo|PFS= The time (weeks) from date of randomization to date of progressive disease(PD). PFS for each randomization arm was estimated using the Kaplan-Meier product-limit method. A point estimate and a 95% confidence interval (CI) for the median PFS was computed for each randomization arm using the Brookmeyer & Crowley method. PD=Increase (≥ 20%) in sum of longest diameters from smallest value during study (including baseline).|Prior to study therapy, at 8 week intervals until progression occurs (maximum participant PFS of 71 weeks)|All randomized participants. Participants who died without reporting tumor progression were considered to have progressed on the death date. Participants who neither progressed nor died were censored on the day of their last on-study tumor assessment or the first date of subsequent therapy.||weeks||95% Confidence Interval|Median
776593|NCT00767572|Primary|Pre-post Change in Brachial Artery Reactivity|Brachial artery reactivity was assessed by Flow-mediated dilatation (FMD), performed before and after the 12 week period on therapy. FMD uses high-frequency ultrasound measurement of changes in brachial artery diameter after a 5-minute blood pressure cuff arterial occlusion. Brachial artery reactivity has been shown to predict long-term cardiovascular events.|Baseline, 12 weeks|12 enrolled participants were randomly assigned to receive a 12-week course of either atorvastatin or placebo, followed by a 4-week washout, then 12 weeks on the alternate intervention.||mm||Standard Deviation|Mean
776594|NCT00767624|Secondary|Percentage of Participants in Insomnia Remission|Remission was defined as endpoint ISI<8. The ISI scale score ranges from 0 to 28 with lower scores representing less severe insomnia. A score of 0-7 is interpreted as absence of insomnia.|16 weeks|||percentage of particpants in arm|||Number
776595|NCT00767624|Primary|Percent of Participants With Depression Remission|"Depression remission was defined if both a and b below are satisfied
absence of both depressed mood and anhedonia for at least three consecutive weeks
no more than two other diagnostic criterion symptoms of depression met for at least three consecutive weeks"|16 weeks|||percentage of participants in arm|||Number
776596|NCT00767676|Primary|Number of Participants That Exhibited a Score Less Than 1.5 on the Jordan-King Scale|"To qualify for the claim of a reduced sensitization potential, all subjects completing the study could exhibit a value of no more than 1.5 on the Jordan-King Scale [scale is 0 (no visible reaction) to 5 (severe erythema)]
No statistical analyses were performed."|7 weeks|Per protocol||participants|||Number
776597|NCT00767767|Primary|GSR Trial 1|Galvanic skin repose (GSR) to the first habituation trial (yes/no). Coding: Yes (0) and No (1)|First Trial, for up to 1 day|||units on a scale||Standard Deviation|Mean
776598|NCT00767806|Secondary|Number of Participants With Suicidal Ideation or Suicidal Behaviors According to the Columbia Suicide Severity Rating Scale|The Columbia Suicide Severity Rating Scale (C–SSRS) captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The scale includes suggested questions to solicit the type of information needed to determine if a suicide-related thought or behavior occurred.|baseline through 12 weeks|All randomized participants.||participants|||Number
776600|NCT00767806|Secondary|Change From Baseline to 12 Week Endpoint in Weight|Least Squares Mean values were controlled for investigator.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.||kilogram||Standard Error|Least Squares Mean
776601|NCT00767806|Secondary|Change From Baseline to 12 Weeks in Blood Pressure|Least Squares Mean values were controlled for investigator.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.||millimeter mercury||Standard Error|Least Squares Mean
776602|NCT00767806|Secondary|Change From Baseline to 12 Week Endpoint in Total Protein|Least Squares Mean values were controlled for investigator.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.||Gram/Liter||Standard Error|Least Squares Mean
776603|NCT00767806|Secondary|Change From Baseline to 12 Week Endpoint in Creatinine|Least Squares Mean values were controlled for investigator.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.||Micromole/Liter||Standard Error|Least Squares Mean
776604|NCT00767806|Secondary|Change From Baseline to 12 Week Endpoint in Aspartate Aminotransferase|Least Squares Mean values were controlled for investigator.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.||Units/Liter||Standard Error|Least Squares Mean
776605|NCT00767806|Secondary|Change From Baseline to 12 Week Endpoint in Alanine Aminotransferase|Least Squares Mean values were controlled for investigator.|baseline, 12 weeks|"All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing.
endpoints."||Units/Liter||Standard Error|Least Squares Mean
776606|NCT00767806|Secondary|Change From Baseline to 12 Week Endpoint in Alkaline Phosphatase|Least Squares Mean values were controlled for investigator.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.||Units/Liter||Standard Error|Least Squares Mean
776607|NCT00767806|Secondary|Change From Baseline to 12 Week Endpoint in Albumin|Least Squares Mean values were controlled for investigator.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.||Gram/Liter||Standard Deviation|Least Squares Mean
776608|NCT00767806|Secondary|Change From Baseline to 12 Weeks in Uric Acid|Least Squares Mean values were controlled for investigator.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.||Micromole/Liter||Standard Error|Least Squares Mean
776609|NCT00767806|Secondary|Participants Who Discontinued From Baseline to 12 Weeks|Reasons for discontinuation are listed in the participant flow.|baseline, 12 weeks|All randomized participants.||participants|||Number
776610|NCT00767806|Secondary|Change From Baseline to 12 Weeks in Work Productivity and Activity Impairment Instrument (WPAI)|"WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment.
Absenteeism
Presenteeism
Work productivity loss
Activity Impairment Scores range from 0 to 1 for each of the above 4 types; higher scores indicate greater impairment."|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints. Not for all participants were data for all WPAI items available.||units on a scale||Standard Deviation|Mean
776611|NCT00767806|Secondary|Change From Baseline to 12 Weeks in European Quality of Life Questionnaire - 5 Dimension|Generic, multidimensional, health-related, quality-of-life instrument. The profile allows patients to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 is generated for each domain. For each patient, the outcome rating on 5 domains will be mapped to a single index through an algorithm. The index ranges between 0 and 1; higher scores indicate a better health state perceived by the patient. Participants were evaluated with the United Kingdom (UK) and the United States (US) population based index score.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.||units on a scale||Standard Deviation|Mean
776612|NCT00767806|Secondary|Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey|The SF-36 Health Status Survey is a generic, health-related scale assessing subjects’ quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). The score for each of the domain and component summary=0-100 (higher scores indicate better health status or functioning).|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.||units on a scale||Standard Deviation|Mean
776613|NCT00767806|Secondary|Change From Baseline to 12 Weeks in Profile of Mood States - Brief Form|The 30-item BPOMS measures mood states and has 6 factors: tension-anxiety (Ten), depression-dejection (Dep), anxiety-hostility (Ang), fatigue (Fat), confusion (Con), and vigor (Vig). Item scores: 0 (not at all) to 4 (extremely). Each factor scores range from 0 to 20. The Total score is sum of all factor scores minus the factor score for vigor (Total=Ten+Dep+Ang+Fat+Con-Vig) and ranges from 0 (least disturbed) to 80 (most disturbed).|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.||units on a scale||Standard Deviation|Mean
776659|NCT00768066|Primary|Incidence of TE-SAE Define as Composite of Death, Non-fatal MI, Stroke, Hospitalization for Worsening Heart Failure, Cardiac Perforation, Pericardial Tamponade, Ventricular Arrhythmias >15 Sec. or With Hemodynamic Compromise or Atrial Fibrillation||one month post-catheterization|||participants|||Number
776614|NCT00767806|Secondary|Change From Baseline to 12 Weeks in Roland Morris Disability Questionnaire|Roland-Morris questionnaire will be completed by the patient and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the patient is instructed to put a mark next to each appropriate statement. The number of statements marked will be added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability). Least Squares Mean values were controlled for investigator and baseline severity.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.||units on a scale||Standard Error|Least Squares Mean
776615|NCT00767806|Secondary|Patient's Global Impression of Improvement (PGI-I) at 12 Weeks|A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). Least Squares Mean values were controlled for investigator and baseline severity.|12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.||units on a scale||Standard Error|Least Squares Mean
776616|NCT00767806|Secondary|Change From Baseline to 12 Weeks Endpoint in Clinical Global Impressions of Severity (CGI-S)|Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Least Squares Mean values were controlled for investigator and baseline severity.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.||units on a scale||Standard Error|Least Squares Mean
776617|NCT00767806|Secondary|Number of Participants Reaching Each Threshold of of BPI Average Pain Score Reduction During the Study - Cumulative Distribution|The results presented are the cumulative number of participants reaching each threshold of BPI average pain reduction. The thresholds are given as percent reductions in BPI average pain score from the baseline score. BPI: a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Number of participants under each threshold was assessed at endpoint.|12 weeks|All randomized participants with non-missing baseline value; baseline observation carried forward method was used to impute missing endpoints.||participants|||Number
776618|NCT00767806|Secondary|Number of Sustained Responders at 12 Week Endpoint|Sustained responders: participants with ≥30% reduction of BPI average pain rating from baseline to endpoint and baseline to earlier visit than last visit and who maintain a ≥20% reduction of BPI average pain rating from baseline at every visit between last visit and earlier visit. BPI: a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Number of sustained responders was assessed at endpoint.|12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.||participants|||Number
776619|NCT00767806|Secondary|Number of Responders: 50 Percent (%) or Greater Reduction of the Brief Pain Inventory (BPI) Average Pain Severity Rating at 12 Week Endpoint|Response to treatment was defined as at least a 50% reduction from baseline to endpoint (last observation carried forward) in the BPI average pain severity score. BPI is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Response was assessed at endpoint.|12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.||participants|||Number
776620|NCT00767806|Secondary|Number of Responders: 30 Percent (%) or Greater Reduction of the Brief Pain Inventory (BPI) Average Pain Severity Rating at 12 Week Endpoint|Response to treatment was defined as at least a 30% reduction from baseline to endpoint (last observation carried forward) in the BPI average pain severity score. BPI is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Response was assessed at endpoint.|12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.||participants|||Number
776621|NCT00767806|Secondary|Change From Baseline to 12 Weeks in Weekly Mean of 24-hour Average Pain, Worst Pain, and Night Pain Rating|24-hour average pain severity scores were recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Patients completed the electronic diary at bedtime. The 11-point Likert scale was also used for assessment of night pain and worst pain each day, and evaluated as weekly means. Least Squares Mean values were controlled for investigator and baseline severity.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.||units on a scale||Standard Error|Least Squares Mean
776622|NCT00767806|Secondary|Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I)|BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.||units on a scale||Standard Deviation|Mean
776623|NCT00767806|Primary|Change From Baseline to 12 Weeks in Brief Pain Inventory 24-hour Average Pain Score|A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Least Squares Mean values were controlled for investigator and baseline severity.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value.||units on a scale||Standard Error|Least Squares Mean
791688|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Hemoglobin)||Baseline up to Month 7|||percentage of participants|||Number
776624|NCT00768040|Primary|Change From Baseline in Central Retinal Thickness in Patients With Type 1 or Type 2 Diabetes, After 12 Weeks of Treatment|The central retinal thickness was measured by Optical coherence tomography (OCT). The changes in central retinal thickness (CRT) from baseline to the end of study at week 12 were analyzed using a univariate analysis of covariance model (ANCOVA) with baseline value as a covariate and treatment as a fixed factor|Baseline to week 12|This study was terminated early due to low recruitment of patients.||μm||Standard Error|Least Squares Mean
776625|NCT00768053|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 90 Response at Week 12|American College of Rheumatology 90% (ACR90) response: responder = ≥90% improvement in tender and swollen joint count and ≥90% improvement in at least 3 of 5 ACR core measures: patient assessment of pain (scored 1=extreme pain to 6=no pain; score transformed to 0 to 100: higher score indicates less pain), Patient’s Global Assessment and Physician’s Global Assessment of disease activity (assess arthritis activity; both scored 0=none to 10=extreme), Modified Health Assessment Questionnaire (assess amount of difficulty to perform an activity scored 0=no difficulty to 3=unable to do), and ESR.|Week 12|All injected subjects population; N=number of participants with evaluable data at observation.||percentage of participants|||Number
776626|NCT00768053|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 70 Response at Week 12|American College of Rheumatology 70% (ACR70) response: responder = ≥70% improvement in tender and swollen joint count and ≥70% improvement in at least 3 of 5 ACR core measures: patient assessment of pain (scored 1=extreme pain to 6=no pain; score transformed to 0 to 100: higher score indicates less pain), Patient’s Global Assessment and Physician’s Global Assessment of disease activity (assess arthritis activity; both scored 0=none to 10=extreme), Modified Health Assessment Questionnaire (assess amount of difficulty to perform an activity scored 0=no difficulty to 3=unable to do), and ESR.|Week 12|All injected subjects population; N=number of participants with evaluable data at observation.||percentage of participants|||Number
776627|NCT00768053|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Week 12|American College of Rheumatology 50% (ACR50) response: responder = ≥50% improvement in tender and swollen joint count and ≥50% improvement in at least 3 of 5 ACR core measures: patient assessment of pain (scored 1=extreme pain to 6=no pain; score transformed to 0 to 100: higher score indicates less pain), Patient’s Global Assessment and Physician’s Global Assessment of disease activity (assess arthritis activity; both scored 0=none to 10=extreme), Modified Health Assessment Questionnaire (assess amount of difficulty to perform an activity scored 0=no difficulty to 3=unable to do), and ESR.|Week 12|All injected subjects population; N=number of participants with evaluable data at observation.||percentage of participants|||Number
776628|NCT00768053|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 12|American College of Rheumatology 20% (ACR20) response: responder = ≥20% improvement in tender and swollen joint count and ≥20% improvement in at least 3 of 5 ACR core measures: patient assessment of pain (scored 1=extreme pain to 6=no pain; score transformed to 0 to 100: higher score indicates less pain), Patient’s Global Assessment and Physician’s Global Assessment of disease activity (assess arthritis activity; both scored 0=none to 10=extreme), Modified Health Assessment Questionnaire (assess amount of difficulty to perform an activity scored 0=no difficulty to 3=unable to do), and ESR.|Week 12|All injected subjects population; N=number of participants with evaluable data at observation.||percentage of participants|||Number
776629|NCT00768053|Secondary|Time to Achievement of Sustained Low Disease Activity Score (LDAS): DAS28 ≤3.2|Time to sustained LDAS measured as maintenance of low disease activity score beyond Week 12. DAS28 calculated from number of painful and swollen joints using 28 joints count (PJC, SJC), ESR (mm/hour), and patient's global assessment of disease activity (arthritis activity measured on 11-point rating scale scored 0 [none] to 10 [extreme]). DAS28 score calculated as 0.56*square root (√) (PJC28) + 0.28 *√ (SJC28) + 0.70*ln ESR + 0.014*PGA*10. DAS28 score >5.1=higher disease activity; ≤3.2=low disease activity; <2.6=clinical remission.|Baseline up to Week 12|All injected subjects population; DAS28 assessed at Week 4 and Week 12; sustained LDAS could only have been observed beyond Week 12. Time to event analysis not possible within study duration.||participants|||Number
776630|NCT00768053|Secondary|Percentage of Participants Achieving > 0.6 DAS28 Response at Week 12|DAS28 calculated from number of painful and swollen joints using 28 joints count (PJC, SJC), ESR (mm/hour), and patient's global assessment of disease activity (arthritis activity measured on 11-point rating scale scored 0 [none] to 10 [extreme]). DAS28 score calculated as 0.56*square root (√) (PJC28) + 0.28 *√ (SJC28) + 0.70*ln ESR + 0.014*PGA*10. DAS28 score >5.1=higher disease activity; ≤3.2=low disease activity; <2.6=clinical remission. Achievement of >0.6 DAS28 response defined as decrease in DAS28 > 0.6 (i.e. change in DAS28 < -0.6).|Week 12|All injected subjects population; N=number of participants with evaluable data at observation.||percentage of participants|||Number
776631|NCT00768053|Secondary|Percentage of Participants Achieving Low Disease Activity (DAS28 ≤3.2) at Week 12|DAS28 calculated from number of painful and swollen joints using 28 joints count (PJC, SJC), ESR (mm/hour), and patient's global assessment of disease activity (arthritis activity measured on 11-point rating scale scored 0 [none] to 10 [extreme]). DAS28 score calculated as 0.56*square root (√) (PJC28) + 0.28 *√ (SJC28) + 0.70*ln ESR + 0.014*PGA*10. DAS28 score >5.1=higher disease activity; ≤3.2=low disease activity; <2.6=clinical remission.|Week 12|All injected subjects population; N=number of participants with evaluable data at observation.||percentage of participants|||Number
776632|NCT00768053|Secondary|Percentage of Participants Achieving Remission (DAS28 <2.6) at Week 12|DAS28 calculated from number of painful and swollen joints using 28 joints count (PJC, SJC), ESR (mm/hour), and patient's global assessment of disease activity (arthritis activity measured on 11-point rating scalescored 0 [none] to 10 [extreme]). DAS28 score calculated as 0.56*square root (√) (PJC28) + 0.28 *√ (SJC28) + 0.70*ln ESR + 0.014*PGA*10. DAS28 score >5.1=higher disease activity; ≤3.2=low disease activity; <2.6=clinical remission.|Week 12|All injected subjects population; N=number of participants with evaluable data at observation.||percentage of participants|||Number
776652|NCT00768066|Secondary|Change From Baseline in the Minnesota Living With Heart Failure (MLHF) Questionnaire Total Score.|Data provided are with respect to the change from baseline at 12-months post-catheterization. The Minnesota living with heart failure questionnaire uses a 6-point, zero to five, Likert scale. The total score is the sum of the 21 responses. The total score is considered the best measure of how heart failure and treatments impact a patients quality of life. The max score is 105, minimum score is 0. A lower score is considered a better quality of life.|12 months post-catheterization|||units on a scale||95% Confidence Interval|Mean
776633|NCT00768053|Secondary|Percentage of Participants Achieving > 1.2 Improvement in DAS28 at Week 12|DAS28 calculated from number of painful and swollen joints using 28 joints count (PJC, SJC), ESR (mm/hour), and patient's global assessment of disease activity (arthritis activity measured on 11-point rating scale scored 0 [none] to 10 [extreme]). DAS28 score calculated as 0.56*square root (√) (PJC28) + 0.28 *√ (SJC28) + 0.70*ln ESR + 0.014*PGA*10. DAS28 score >5.1=higher disease activity; ≤3.2=low disease activity; <2.6=clinical remission. Achievement of >1.2 improvement defined as decrease in DAS28 >1.2 (i.e., change in DAS28 < -1.2).|Week 12|All injected subjects population; N=number of participants with evaluable data at observation.||percentage of participants|||Number
776634|NCT00768053|Secondary|Percentage of Participants Achieving a Patient Acceptable Symptom State (PASS) Score at Week 12 Who Had an Acceptable Symptom State at Week 4, Week 12, or Last Observation (Last Obs)|PASS is a 1-question assessment of how rheumatoid arthritis has affected the participant in the last 48 hours (If you were to remain in the next few months as you were during the last hours, would this be acceptable or unacceptable to you?). PASS score at Week 12 calculated on participants with Acceptable symptom state achieved at observation.|Week 4, Week 12, and Last observation up to Week 12|All injected subjects population; (n) includes participants with analyzable data at observation (responses of Acceptable or Unacceptable).||percentage of participants|||Number
776635|NCT00768053|Secondary|Percentage of Participants Achieving a Patient Acceptable Symptom State (PASS) Score at Week 4 Who Had an Acceptable Symptom State at Week 4, Week 12, or Last Observation (Last Obs)|PASS is a 1-question assessment of how rheumatoid arthritis has affected the participant in the last 48 hours (If you were to remain in the next few months as you were during the last hours, would this be acceptable or unacceptable to you?). PASS score at Week 4 calculated on participants with Acceptable symptom state achieved at observation.|Week 4, Week 12, and Last observation up to Week 12|All injected subjects population; (n) includes participants with analyzable data at observation (responses of Acceptable or Unacceptable).||percentage of participants|||Number
776636|NCT00768053|Secondary|Patient Acceptable Symptom State (PASS) of the EULAR-RAID Score: 75th Percentile of Change at Week 4 and Week 12|PASS is a 1-question assessment of how rheumatoid arthritis has affected the participant in the last 48 hours (If you were to remain in the next few months as you were during the last hours, would this be Acceptable or Unacceptable to you?). PASS score is defined as the 75th percentile of the change in EULAR-RAID score between baseline and observation among participants whose evaluation of their symptom state at observation was Acceptable.|Week 4, Week 12|All injected subjects population. Unacceptable value put to participants prematurely withdrawn or with missing data; (n) includes participants with analyzable data at observation (responses of Acceptable or Unacceptable).||scores on a scale|||Number
776637|NCT00768053|Secondary|Percentage of Participants Achieving a Minimal Clinically Important Improvement Score at Week 12 Who Had Moderately or Slightly Important Improvement at Week 4, Week 12, or Last Observation (Last Obs)|MCII is a 2-question assessment of how rheumatoid arthritis has affected the participant in the last 48 hours. Question 1: in comparison to study start (Improved, No change, or Worse). Question 2: if response was Improved, participant rated how important the improvement was (Very important, Moderately important, Slightly important, or Not important at all). MCII score at Week 12 calculated on participants with Moderately or Slightly important improvement (Mod/Slightly Imp Improvement) achieved at observation.|Week 4, Week 12, and Last observation up to Week 12|All injected subjects population; (n) includes participants with analyzable data at observation (responses of Yes or No).||percentage of participants|||Number
776638|NCT00768053|Secondary|Percentage of Participants Achieving a Minimal Clinically Important Improvement (MCII) Score at Week 4 Who Had Moderately or Slightly Important Improvement at Week 4, Week 12, or Last Observation (Last Obs)|MCII is a 2-question assessment of how rheumatoid arthritis has affected the participant in the last 48 hours. Question 1: in comparison to study start (Improved, No change, or Worse). Question 2: if response was Improved, participant rated how important the improvement was (Very important, Moderately important, Slightly important, or Not important at all). MCII score at Week 4 calculated on participants with Moderately or Slightly important improvement (Mod/Slightly Imp Improvement) achieved at observation.|Week 4, Week 12, and Last observation up to Week 12|All injected subjects population; (n) includes participants with analyzable data at observation (responses of Yes or No).||percentage of participants|||Number
776639|NCT00768053|Secondary|Minimal Clinically Important Improvement (MCII) of the EULAR-RAID Score: 75th Percentile of Change at Week 4 and Week 12|MCII is a 2-question assessment of how rheumatoid arthritis has affected the participant in the last 48 hours. Question 1: in comparison to study start (Improved, No Change, or Worse). Question 2: if response was Improved, participant rated how important the improvement was (Very important, Moderately important, Slightly important, or Not important at all). The MCII score is defined as the 75th percentile of the change in EULAR-RAID score between baseline and observation among participants whose evaluation of the response therapy at observation was Moderately or Slightly important improvement.|Week 4, Week 12|All injects subjects population; (n) includes participants with analyzable data at observation (responses of Yes or No).||scores on a scale|||Number
776640|NCT00768053|Secondary|Percentage of Participants Achieving a Moderate or Good EULAR Response Rate at Week 12|EULAR response rate is based on DAS28. For DAS28 ≤3.2 at observation (low disease activity), change from baseline of <-1.2=good response or ≥-1.2 to <-0.6=moderate response; DAS28 >3.2 to 5.1 at observation (moderate or high disease activity), change from baseline of <-1.2 or ≥-1.2 to <-0.6=moderate response; DAS28 >5.1 (high disease activity) at observation, change from baseline of <-1.2=moderate response. DAS28 calculated using the 28 joints count, ESR mm/hour, and PGA of disease activity (participant rated arthritis activity measured on 11-point rating scale: 0 [none] to 10 [extreme]).|Week 12|All injected subjects population; N=number of participants with evaluable data at observation.||percentage of participants|||Number
776641|NCT00768053|Primary|Sensitivity to Change of the EULAR-RAID Score: Change From Baseline to Week 12|Sensitivity to change analyzed by testing if the difference of change from baseline of EULAR-RAID score minus the change from baseline of each component (pain, functional disability, fatigue, sleep disturbance, coping, overall physical and emotional well-being with score range 0 [not affected, very good] to 10 [most affected]) was different from 0 or not. Results expressed as standardized response mean (SRM) calculated as ratio of mean change over standard deviation of the change. A non significant test (p value ≥0.05) means the component had a significant influence to global EULAR RAID score.|Baseline, Week 12|All injected subjects population||standardized response mean|||Number
776642|NCT00768053|Primary|Sensitivity to Change of the EULAR-RAID Score: Change From Baseline to Week 4|Sensitivity to change analyzed by testing if the difference of change from baseline of EULAR-RAID score minus the change from baseline of each component (pain, functional disability, fatigue, sleep disturbance, coping, overall physical and emotional well-being with score range 0 [not affected, very good] to 10 [most affected]) was different from 0 or not. Results expressed as standardized response mean (SRM) calculated as ratio of mean change over standard deviation of the change. A non significant test (p value ≥0.05) means the component had a significant influence to global EULAR RAID score.|Baseline, Week 4|All injected subjects population||standardized response mean|||Number
776643|NCT00768053|Primary|Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Patient Global Assessment (PGA) of Health Status: Time-normalized Average|Time-normalized average is the area under the curve (AUC) / time between first and last observations. PGA of health status is a single-item participant rated response to the question “in general, how would you rate your health over the last 2 to 3 weeks”; scored 0 (very well) to 10 (extremely bad). Face validity assessed using a correlation coefficient between the EULAR-RAID score and PGA health status score. A higher correlation coefficient indicates greater EULAR-RAID score validity (best >0.85).|Baseline, Last observation up to Week 12|All injected subjects population; score profile from baseline to last observation post-baseline.||correlation coefficient||95% Confidence Interval|Number
776644|NCT00768053|Primary|Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Patient Global Assessment (PGA) of Health Status: Week 12|PGA of health status is a single-item participant rated response to the question “in general, how would you rate your health over the last 2 to 3 weeks”; scored 0 (very well) to 10 (extremely bad). Face validity assessed using a correlation coefficient between the EULAR-RAID score and PGA health status score. A higher correlation coefficient indicates greater EULAR-RAID score validity (best >0.85).|Week 12|All injected subjects population||correlation coefficient||95% Confidence Interval|Number
776645|NCT00768053|Primary|Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Patient Global Assessment (PGA) of Health Status|PGA of health status is a single-item participant rated response to the question “in general, how would you rate your health over the last 2 to 3 weeks”; scored 0 (very well) to 10 (extremely bad). Face validity assessed using a correlation coefficient between the EULAR-RAID score and the PGA. A higher correlation coefficient indicates greater EULAR-RAID score validity (best >0.85).|Baseline, Week 4|All injected subjects population||correlation coefficient||95% Confidence Interval|Number
776646|NCT00768053|Primary|Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Disease Activity Score Based on 28-joints Count (DAS28): Time-normalized Average|Time-normalized average is the area under the curve (AUC) / time between first and last observations. DAS28 calculated from number of swollen joints and painful joints using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity question measured on an 11-point rating scale scored 0 [none] to 10 [extreme]). Face validity assessed using a correlation coefficient between the EULAR-RAID and DAS28 scores. A higher correlation coefficient indicates greater EULAR-RAID score validity.|Baseline, Last observation up to Week 12|All injected subjects population; score profile from baseline to last observation post-baseline.||correlation coefficient||95% Confidence Interval|Number
776647|NCT00768053|Primary|Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Disease Activity Score Based on 28-joints Count (DAS28): Week 12|DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity question measured on an 11-point rating scale scored 0 [none] to 10 [extreme]). Face validity assessed using a correlation coefficient between the EULAR-RAID score and the DAS28. A higher correlation coefficient indicates greater EULAR-RAID score validity.|Week 12|All injected subjects population||correlation coefficient||95% Confidence Interval|Number
776648|NCT00768053|Primary|Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Disease Activity Score Based on 28-joints Count (DAS28)|DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity question measured on an 11-point rating scale scored 0 [none] to 10 [extreme]). Face validity assessed using a correlation coefficient between the EULAR-RAID score and the DAS28. A higher correlation coefficient indicates greater EULAR-RAID score validity.|Baseline, Week 4|All injected subjects population||correlation coefficient||95% Confidence Interval|Number
776649|NCT00768053|Primary|Simplicity: Time for Completion of the EULAR-RAID Questionnaire|EULAR-RAID is an assessment of patient reported outcomes for pain, functional disability, fatigue, sleep disturbance, coping, overall assessments of physical well-being and emotional well-being based on 7 numerical rating scales (NRS) questions. NRS individual questions with range of 0 (not affected, very good) to 10 (most affected) weighted and calculated with a total score range of 0 (not affected, very good) to 10 (most affected).|Baseline up to Week 12|All injected subjects population. Data was not summarized; the time to complete the EULAR-RAID questionnaire was not analyzed separately from other components of the EULAR questionnaire (EULAR-RAID, questions on pain, Modified Health Assessment Questionnaire, sleep and coping)||minutes||Standard Deviation|Mean
776650|NCT00768053|Primary|Reliability of the European League Against Rheumatism - Rheumatism Arthritis Impact of Disease (EULAR-RAID) Score|EULAR-RAID score reliability assessed using an intraclass correlation coefficient (using a consistency definition where the between-measure variance is excluded from the denominator variance and its 95% confidence interval) and the standard error of measurement (SEM) and its 95% confidence interval (CI). A higher intraclass correlation coefficient (ICC) indicates greater score reliability (0.0 to 0.10=virtually none; 0.11 to 0.40=slight; 0.41 to 0.60=fair; 0.61 to 0.80=moderate; 0.81 to 1.00=substantial).|Screening, baseline|All injected subjects population: received at least 1 dose of study treatment (same as Safety population).||intraclass correlation coefficient||95% Confidence Interval|Number
776651|NCT00768066|Secondary|Percent Change From Baseline in Scar Mass as a Fraction of Left Ventricle Mass by Cardiac MRI or CT.|Data provided are with respect to the change from baseline at 12-months post-catheterization.|12 Months post-catheterization|||percent change||95% Confidence Interval|Mean
776653|NCT00768066|Secondary|Change From Baseline in Distance Walked in Six-minutes (Six-minute Walk Test).|Data provided are with respect to the change from baseline at 12-months post-catheterization.|12 months post-catheterization|||meters||95% Confidence Interval|Mean
776660|NCT00768118|Primary|The Magnitude of Change in Blood Lymphocyte NF-kB Level|The target accrual goal is 15 subjects. It is hoped that of those 15, at least 10 will be intervention compliant, and provide both planned blood samples. NF-kB levels will be measured using a supershift assay, which tests the specificity and level of NF-kB in the sample by measuring the optical density of a scan. With 10 patients, the mean difference in blood lymphocyte NF-kB level could be estimated to within 0.44 standard 7 deviations, with 80% confidence. That is reasonable precision and confidence level for a small pilot study, and should provide sufficiently precise estimates for use in planning a subsequent study.|15 days|||Optical Density unit||90% Confidence Interval|Mean
776661|NCT00768144|Secondary|Progression-Free Survival|Progression-free survival estimated using Kaplan-Meier methods is defined as the time from registration to the earlier of death or disease progression. Patients alive without disease progression are censored at the date of last disease evaluation. Progressive disease (PD) based on RECIST 1.0 is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Equivocal progression of non-target lesions also qualifies as PD.|Clinical assessments were performed weekly for first 4 weeks and every 2 weeks in subsequent cycles. Disease was evaluated radiologically at baseline, before each odd cycle and at end of treatment.|The analysis dataset is comprised of all treated patients.||weeks||95% Confidence Interval|Median
776662|NCT00768144|Secondary|16-Week Progression-Free Survival|16-week progression-free survival is the probability of patients remaining alive and progression-free at 16-weeks from study entry estimated using Kaplan-Meier methods. Patients alive and progression-free at last follow-up are censored. Progressive disease (PD) based on RECIST 1.0 is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or equivocal progression of non-target lesions.|Clinical assessments were performed weekly for first 4 weeks and every 2 weeks in subsequent cycles. Disease was evaluated radiologically at baseline, before each odd cycle and at end of treatment.|The analysis dataset is comprised of all treated patients.||probability||95% Confidence Interval|Number
776663|NCT00768144|Primary|Overall Response Rate|Best response on treatment was based on RECIST 1.0 criteria with overall response defined as achieving partial response (PR) or complete response (CR). Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.|Clinical assessments were performed weekly for first 4 weeks and every 2 wks in subsequent cycles. Disease was evaluated radiologically at baseline, before each odd cycle and at end of trt.|The analysis dataset is comprised of all treated patients.||proportion of participants||90% Confidence Interval|Number
776664|NCT00768222|Secondary|Mean Surgical Site Infection Score on Modified ASEPSIS Scale|Post-operative assessment of wound by trained observer to identify SSI based on several characteristics that are assigned points that contribute to a total score, with 0-10 representing satisfactory healing (best), 11-20 representing disturbance of healing, 21-30 representing minor wound infection, 31-40 representing moderate wound infection, and over 40 representing severe wound infection (worst)|Day 90|Intention to treat (ITT)||score on scale||Standard Deviation|Mean
776665|NCT00768222|Secondary|Mean Surgical Site Infection Score on Modified ASEPSIS Scale|Post-operative assessment of wound by trained observer to identify SSI based on several characteristics that are assigned points that contribute to a total score, with 0-10 representing satisfactory healing (best), 11-20 representing disturbance of healing, 21-30 representing minor wound infection, 31-40 representing moderate wound infection, and over 40 representing severe wound infection (worst)|Day 30|Intention to treat (ITT)||score on scale||Standard Deviation|Mean
776666|NCT00768222|Secondary|Mean Surgical Site Infection Score on Modified ASEPSIS Scale|Post-operative assessment of wound by trained observer to identify SSI based on several characteristics that are assigned points that contribute to a total score, with 0-10 representing satisfactory healing (best), 11-20 representing disturbance of healing, 21-30 representing minor wound infection, 31-40 representing moderate wound infection, and over 40 representing severe wound infection (worst)|Day 12|Intention to treat (ITT)||score on scale||Standard Deviation|Mean
776667|NCT00768222|Secondary|Mean Surgical Site Infection Score on Modified ASEPSIS Scale|Post-operative assessment of wound by trained observer to identify SSI based on several characteristics that are assigned points that contribute to a total score, with 0-10 representing satisfactory healing (best), 11-20 representing disturbance of healing, 21-30 representing minor wound infection, 31-40 representing moderate wound infection, and over 40 representing severe wound infection (worst)|Day 7|Intention to treat (ITT)||score on scale||Standard Deviation|Mean
776668|NCT00768222|Secondary|Mean Surgical Site Infection Score on Modified ASEPSIS Scale|Post-operative assessment of wound by trained observer to identify SSI based on several characteristics that are assigned points that contribute to a total score, with 0-10 representing satisfactory healing (best), 11-20 representing disturbance of healing, 21-30 representing minor wound infection, 31-40 representing moderate wound infection, and over 40 representing severe wound infection (worst)|Day 5|Intention to treat (ITT)||score on scale||Standard Deviation|Mean
776669|NCT00768222|Secondary|Mean Surgical Site Infection Score on Modified ASEPSIS Scale|Post-operative assessment of wound by trained observer to identify SSI based on several characteristics that are assigned points that contribute to a total score, with 0-10 representing satisfactory healing (best), 11-20 representing disturbance of healing, 21-30 representing minor wound infection, 31-40 representing moderate wound infection, and over 40 representing severe wound infection (worst)|Day 3|Intention to treat (ITT)||score on scale||Standard Deviation|Mean
776670|NCT00768222|Secondary|Mean Cosmetic Outcome Score on Modified Hollander Scale|Post-operative cosmetic outcome assessed on surgical site by investigator using the modified Hollander Cosmetic Scale (mHCS) with 0 representing worst and 6 representing best, calculated by adding the individual scores on each of 6 categories (step-off borders, contour irregularities, wound margin separation, edge inversion, excessive inflammation, and overall appearance|30 days|Intention to treat (ITT)||score on scale||Standard Deviation|Mean
776671|NCT00768222|Secondary|Mean Cosmetic Outcome Score on Modified Hollander Scale|Post-operative cosmetic outcome assessed on surgical site by investigator using the modified Hollander Cosmetic Scale (mHCS) with 0 representing worst and 6 representing best, calculated by adding the individual scores on each of 6 categories (step-off borders, contour irregularities, wound margin separation, edge inversion, excessive inflammation, and overall appearance|12 days|Intention to treat (ITT)||score on scale||Standard Deviation|Mean
776672|NCT00768222|Primary|Mean Score on Cosmetic Outcome Visual Analog Scale (VAS)|Post-operative cosmetic outcome assessed on surgical site photographs by an independent blinded central assessor using a validated 100 mm visual analog scale, with 0 representing the worst possible scar and 100 representing the best possible scar|30 days (+/- 5) post-operative|Intention to treat (ITT)||score on scale||Standard Deviation|Mean
776673|NCT00768300|Secondary|Percentage of Participants Who Developed PH on Study|The percentage of participants known to have developed pulmonary hypertension on study documented by right heart catheterization (RHC) was analyzed. RHC was done at baseline and 48 weeks, or at the early termination visit.|Up to 48 weeks|Participants in the Full Analysis Set without PH at baseline were analyzed.||percentage of participants|||Number
776674|NCT00768300|Secondary|Change in Dyspnea Score at Week 48 as Assessed by the Transitional Dyspnea Index (TDI)|The transitional focal score (-9 to 9) is the sum of relative change from baseline for the Functional Impairment, Magnitude of Task, and Magnitude of Effort scores (each -3 to 3 scale). A TDI score of -9 represents a maximum degradation of all three tests; a score of 9 represents a maximum improvement of all three tests.|Baseline and Week 48|Participants in the Full Analysis Set with evaluable change data were analyzed.||units on a scale||Standard Deviation|Mean
776675|NCT00768300|Secondary|Change in Quality of Life (QOL) Score at Week 48 as Assessed by the St. George’s Respiratory Questionnaire (SGRQ)|The SGRQ is designed to measure impact on overall health, daily life, and perceived well-being in participants with obstructive airways disease. The range of each score is 0-100, with 0 indicating fewer limitations and 100 indicating more limitations; an increase in score indicates an increase in limitations.|Baseline and Week 48|Participants in the Full Analysis Set with evaluable change data were analyzed.||units on a scale||Standard Deviation|Mean
776676|NCT00768300|Secondary|Change in Quality of Life (QOL) Score at Week 48 as Assessed by the Short-Form 36® (SF-36)|The range of each health domain score is 0-100, with 0 indicating a poorer health state and 100 indicating a better health state. An increase in score indicates an improvement in health state.|Baseline and Week 48|Participants in the Full Analysis Set with evaluable change data were analyzed.||units on a scale||Standard Deviation|Mean
776677|NCT00768300|Secondary|Change in 6MWT at Week 48|The 6MWT is a measure of exercise tolerance, and measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface.|Baseline and Week 48|Participants in the Full Analysis Set with evaluable change data were analyzed.||meters||Standard Deviation|Mean
776678|NCT00768300|Secondary|Change in DLCO % Predicted at Week 48|DLCO is the extent to which oxygen passes from the air sacs of the lungs into the blood. DLCO % predicted is defined as DLCO % of the participant divided by the average DLCO % in the population for any person of similar age, sex and body composition.|Baseline and Week 48|Participants in the Full Analysis Set with evaluable change data were analyzed.||percent change in DLCO % predicted||Standard Deviation|Mean
776679|NCT00768300|Secondary|Change in FVC % Predicted at Week 48|FVC is defined as the volume of air (liters) that can forcibly be blown out after taking a full breath. FVC % predicted is defined as FVC % of the participant divided by the average FVC % in the population for any person of similar age, sex, and body composition.|Baseline and Week 48|Participants in the Full Analysis Set with evaluable change data were analyzed.||percent change in FVC % predicted||Standard Deviation|Mean
776680|NCT00768300|Secondary|Proportion of Participants With No Disease Progression or Death at 48 Weeks|The proportion of participants with no disease progression or death is presented as a percentage using a Kaplan-Meier (KM) estimate of survival or not experiencing disease progression.|Baseline and Week 48|Full Analysis Set||percentage of participants|||Number
776681|NCT00768300|Primary|Time to Death or Disease (IPF) Progression.|"The median time to death or disease progression was based on Kaplan-Meier (KM) estimates of pooling over strata, and was defined as the first occurrence of any of the following:
Either 1) a decrease of ≥ 10% in FVC (L) and a decrease of ≥ 5% in diffuse lung capacity for carbon monoxide (DLCO) (ml/min/mmHg), or 2) a decrease of ≥ 5% in FVC (L) and a decrease of ≥ 15% in DLCO (ml/min/mmHg); deterioration in FVC and DLCO must be confirmed at the subsequent visit within 28 (± 14) days
Respiratory hospitalization (hospitalization involving worsening of, or deterioration in respiratory symptoms, gas exchange/hypoxemia, or radiographic findings on chest x-ray or high-resolution computerised tomography (HRCT) scan
All-cause mortality"|Up to 48 months|Full Analysis Set: participants who were randomized and treated||weeks||Inter-Quartile Range|Median
776682|NCT00768430|Primary|MADRS|Montgomery-Asberg Depression Rating Scale, each of the ten items can be scored from 0 (absence of symptoms to 6 most severe) and has a total score range of 0-60. A lower score on a MADRS indicates a less severe depression.|24 hours post-infusion|||units on a scale||95% Confidence Interval|Mean
776683|NCT00768521|Secondary|Change From Baseline in Maximum Cystometric Capacity at 4 Hours Post Dose 1 on Tolterodine 4 mg and Placebo|Change from baseline in maximum cystometric capacity at 4 hours post dose 1 on tolterodine 4 mg and placebo (analysis on natural log transformed data)|4 hours post dose 1|All patients||Percentage change||90% Confidence Interval|Least Squares Mean
776684|NCT00768521|Primary|Change From Baseline in Maximum Cystometric Capacity at 4 Hours Post Dose 7 on Tolterodine 4 mg and Placebo|Change from baseline in maximum cystometric capacity at 4 hours post dose 7 on tolterodine 4 mg and placebo (analysis on natural log transformed data)|4 hours post dose 7|All patients||Percentage change||90% Confidence Interval|Least Squares Mean
776685|NCT00768560|Secondary|Target Blood Pressure Achievement in All Subjects|Subjects (≥65 years) without diabetes mellitus or chronic renal disorders and target BP SBP <140 mm Hg and DBP <90 mm Hg. Subjects (<65 years) without diabetes mellitus or chronic renal disorder and target BP SBP <130 mm Hg and DBP <85 mm Hg. Subjects with diabetes mellitus or chronic renal disorders and target BP SBP <130 mm Hg and DBP <80 mm Hg.|After 2 weeks treatment|Subjects valid for efficacy analysis||participants|||Number
776686|NCT00768560|Secondary|Target Blood Pressure Achievement in Subjects With Diabetes Mellitus or Chronic Renal Disorder|Subjects with diabetes mellitus or chronic renal disorders and target BP SBP <130 mm Hg and DBP <80 mm Hg|After 2 weeks treatment|Subjects valid for efficacy analysis||participants|||Number
776689|NCT00768560|Secondary|Differences of Diastolic Blood Pressure Profile|Differences in blood pressure at the same time points (0, 2, 4, 6, 8, 10, 12, 24-hour post-dose) between 2 different days (ie, end of baseline treatment period and end of 2-week treatment period)|Baseline and after 2 weeks treatment|Subjects valid for efficacy analysis||mm Hg||Standard Deviation|Mean
776690|NCT00768560|Secondary|Differences of Systolic Blood Pressure Profile|Differences in blood pressure at the same time points (0, 2, 4, 6, 8, 10, 12, 24-hour post-dose) between 2 different days (ie, end of baseline treatment period and end of 2-week treatment period)|Baseline and after 2 weeks treatment|Subjects valid for efficacy analysis||mm Hg||Standard Deviation|Mean
776691|NCT00768560|Primary|Change of Sitting Blood Pressure|Changes of sitting SBP and DBP (trough values) from baseline (ie [trough BP at the end of each period during the double-blind treatment period] minus [trough BP at the end of the baseline treatment period])|Baseline and after 2 weeks treatment|Per-protocol efficacy population: subjects valid for safety analysis who have no critical protocol deviation and have trough BP at the end of baseline treatment period and trough BP at the end of period 1 are considered valid for the analysis.||mm Hg||Standard Error|Least Squares Mean
776692|NCT00768599|Secondary|Mycological Cure: Mocassin Disease|Negative KOH and negative fungal culture at Day 43|43|MITT||Participants|||Number
776693|NCT00768599|Secondary|Mycological Cure: Interdigital Disease|Negative KOH and negative fungal culture at Day 43|43|MITT||Participants|||Number
776694|NCT00768599|Secondary|Effective Treatment: Mocassin Disease|Negative KOH, negative fungal culture, no or mild (a score of 0 or 1) erythema and/or scaling with all other signs or symptoms being absent (score = 0) at Day 43 (Week6).|43|MITT||Participants|||Number
776695|NCT00768599|Primary|Complete Cure Rate: Moccasin Disease|A negative KOH and negative culture and no evidence of clinical disease as indicated by scores of 0 for each sign and symptom at Day 43.|43 Days|MITT||Participants|||Number
776696|NCT00768599|Secondary|Effective Treatment: Interdigital Disease|Negative KOH, negative fungal culture, no or mild (a score of 0 or 1) erythema and/or scaling with all other signs or symptoms being absent (score = 0) at Day 43 (Week6).|43|MITT||Participants|||Number
776697|NCT00768599|Primary|Complete Cure Rate: Interdigital Disease|A negative KOH and negative culture and no evidence of clinical disease as indicated by scores of 0 for each sign and symptom at Day 43.|Day 43|MITT||Participants|||Number
776698|NCT00768651|Secondary|Blood Glucose Laboratory Value Before Mixed Meal Tolerance Test (MMTT) After the 3 Month Washout Period|Measuring Blood Glucose before and 90 minutes after Mixed Meal Tolerance Test (MMTT) [Ryan: 2005ts] at baseline, 6 and 9 months to assess Graft function.|After the 3 month washout period||||||
776699|NCT00768651|Secondary|Glucose Laboratory Value at 90 Minutes After Mixed Meal Tolerance Test (MMTT) After the 3 Month Washout Period.|Measuring Blood Glucose before and 90 minutes after Mixed Meal Tolerance Test (MMTT) [Ryan: 2005ts] at baseline, 6 and 9 months to assess Graft function.|3 months - washout period||||||
776700|NCT00768651|Secondary|C-peptide Laboratory Value Before a Mixed Meal Tolerance Test (MMTT) After the 3 Month Washout Period.|Measuring of C-peptide before and 90 minutes after a mixed meal tolerance test (MMTT) [Ryan:2005ts] at baseline, 6 and 9 months to assess Graft function.|3 months - washout period||||||
776701|NCT00768651|Secondary|C-peptide Plasma Laboratory Value at 90 Minutes After a Mixed Meal Tolerance Test (MMTT) at the End of the 3 Month Washout Period.|Measuring of C-peptide before and 90 minutes after a Mixed Meal Tolerance Test (MMTT) [Ryan:2005ts] at baseline, 6 and 9 months to assess Graft function. Ther|After the 3 month washout period||||||
776702|NCT00768651|Secondary|HbA1c Plasma Laboratory Value for Participants After the 3 Month Washout Period|Measuring of HbA1c using method (manufacturer) at baseline, and months: 1, 3, 6, 9.|After the 3 month washout period||||||
776703|NCT00768651|Secondary|Acute Insulin Response to Arginine After the 3 Month Washout Period|An intravenous Arginine stimulation test (AST) [Ryan:2002cg] was performed at baseline, 6, and 9 months to assess Graft function. The Arginine is a proxy for insulin secretory reserve (Robertson:2004br)(Rickels:2007cg) and correlates with islet mass in the context of islet allo-transplant (Ryan:2002cg), auto-transplant (Teuscher:1998eu) and hemipancreatectomy (Seaquist:1992iv). An increase in Arginine (AIRarg) would have suggested an increase in beta cell mass.|3 months - washout period||||||
776704|NCT00768651|Primary|Weight Change From Baseline After 6 Months of Therapy|Measuring the weight change from baseline at months: 1, 3, 6 and 9.|6 months||||||
776705|NCT00768651|Primary|Blood Glucose Laboratory Value Before Mixed Meal Tolerance Test (MMTT) After 6 Months of Therapy||6 months||||||
776706|NCT00768651|Primary|Glucose Laboratory Value at 90 Minutes After Mixed Meal Tolerance Test (MMTT) After 6 Months of Therapy.|Measuring Glucose before and 90 minutes after Mixed Meal Tolerance Test (MMTT) [Ryan: 2005ts] at baseline, 6 and 9 months to assess Graft function.|6 months||||||
776707|NCT00768651|Primary|C-peptide Laboratory Value Before a Mixed Meal Tolerance Test (MMTT) After 6 Months of Therapy|Measuring of C-peptide before and 90 minutes after a mixed meal tolerance test (MMTT) [Ryan:2005ts] at baseline, 6 and 9 months to assess Graft function.|6 months||||||
776708|NCT00768651|Primary|C-peptide Laboratory Value at 90 Minutes After a Mixed Meal Tolerance Test (MMTT) After 6 Months of Therapy|Measuring of C-peptide before and 90 minutes after a mixed meal tolerance test (MMTT) [Ryan:2005ts] at baseline, 6 and 9 months to assess Graft function.|6 months||||||
776709|NCT00768651|Primary|Acute Insulin Responses to Arginine After 6 Months of Therapy|An intravenous arginine stimulation test (AST) [Ryan:2002cg] was performed at baseline, 6, and 9 months to assess Graft function.|6 months||||||
776710|NCT00768651|Primary|HbA1c Plasma Laboratory Value for Participants After 6 Months of Therapy|HbA1c was measured at baseline, 3, 6, and 9 months using method (manufacturer.|6 months||||||
776711|NCT00768651|Primary|Change From Baseline on Gastrin Level After One Month of Therapy|Gastrin levels were measured at baseline and at one month by method (manufacturer).|Baseline and One month||||||
776712|NCT00768651|Primary|Change From Baseline of GLP-1 Level After One Month of Therapy|Fasting Glucagon-Like Peptide (GLP-1) levels were measured at baseline and one month. Blood samples were collected in p700 vacutainers (Becton Dickinson, Franklin Lakes, NJ) containing a Dipeptidyl peptidase-4 (DPP4) protease inhibitor cocktail to measure total and active GLP-1 in duplicate using a commercially available ELISA (kit manufacturer) and expressed as the ratio of active:total GLP-1.|Baseline and One month||||||
776718|NCT00768651|Secondary|Insulin Independence After the 3 Month Washout Period|Insulin independence was defined as no insulin use for at least one week, HbA1c < 6.0%, fasting plasma glucose < 7.0 mmol/l, fasting or stimulated c-peptide ≥ 0.5 ng/ml. In addition capillary blood glucose levels could not be >7.8 mmol/l (fasting) or > 10 mmol/l (post-prandial) on more than three occasions in the preceding week. Mean daily insulin use was calculated from the three days prior to study visits. Blinded continuous glucose monitoring (CGM) was performed using the iPro device and Carelink software (Medtronic, Mississauga, ON, CA).|After the 3 month washout period|Per Protocol Set of participants; The subset of participants in full analysis set who were: compliant with the protocol, compliant with pre-specified exposure to the treatment regimen, and available for measurements of primary and secondary variables.||% of insulin indipendent participants|||Number
776719|NCT00768651|Primary|The Primary Endpoint Will be Insulin Independence After 6 Months of Therapy.|Insulin independence was defined as no insulin use for at least one week, HbA1c < 6.0%, fasting plasma glucose < 7.0 mmol/l, fasting or stimulated c-peptide ≥ 0.5 ng/ml. In addition capillary blood glucose levels could not be >7.8 mmol/l (fasting) or > 10 mmol/l (post-prandial) on more than three occasions in the preceding week. Mean daily insulin use was calculated from the three days prior to study visits. Blinded continuous glucose monitoring (CGM) was performed using the iPro device and Carelink software (Medtronic, Mississauga, ON, CA).|6 months|Per Protocol Set of participants: The participants of subjects in full analysis set who were: compliant with the protocol, compliant with pre-specified exposure to the treatment regimen, and available for measurements of primary variables.||proportion of participants||95% Confidence Interval|Number
776720|NCT00768755|Secondary|Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Symptom Interference Score|Symptom interference score is comprised of average of 6 function items from MDASI core (general activity, mood, work, relations with others, walking, and enjoyment of life) and ranges from 0 to 10. Participants were asked to rate how much symptoms have interfered in last 24 hours; each item rated from 0 to 10, with 0 = did not interfere and 10 = interfered completely. Lower scores indicated better outcome.|Phase 2 baseline (Cycle1/Day1), Cycle1/Day8, then Day 1 and 8 of each cycle of chemotherapy (C) up to CycleC6, Day 1 of each cycle of single-agent phase (A) up to CycleA8 and EOT|FA population; ‘N’ (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ is number of participants analyzed at specific time point for each treatment arm respectively.||units on a scale||95% Confidence Interval|Mean
776721|NCT00768755|Secondary|Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Symptom Severity Score|Symptom severity score is comprised of average of 13 MDASI core items (pain, fatigue, nausea, disturbed sleep, distressed, shortness of breath, remembering things, lack of appetite, drowsy, dry mouth, sadness, vomiting, numbness or tingling) and ranges from 0 to 10. Participants were asked to rate severity of each symptom at their worst in last 24 hours; each item rated from 0 to 10, with 0 = symptom not present and 10 = as bad as you can imagine. Lower scores indicated better outcome.|Phase 2 baseline (Cycle1/Day1), Cycle1/Day8, then Day 1 and 8 of each cycle of chemotherapy (C) up to CycleC6, Day 1 of each cycle of single-agent phase (A) up to CycleA8 and end of treatment (EOT)|FA population; ‘N’ (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ is number of participants analyzed at specific time point for each treatment arm respectively.||units on a scale||95% Confidence Interval|Mean
776722|NCT00768755|Secondary|Duration of Response (DR)|Time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause, whichever occurs first. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Phase 2 baseline until the date of first documented progression or discontinuation from the study due to any cause or initiation of subsequent anticancer therapy, assessed every 6 weeks up to 84 weeks|Subgroup of participants from the FA population with a confirmed objective tumor response (CR or PR).||months||95% Confidence Interval|Median
776723|NCT00768755|Secondary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR based assessment of confirmed complete response (CR)/confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors(RECIST).Confirmed responses: those persist on repeat imaging study at least 4 weeks after initial documentation of response.CR: disappearance of all lesions (target/non target) and no appearance of new lesions.PR: those with at least 30 % decrease in sum of longest dimensions of target lesions taking as reference baseline sum longest dimensions,without progression of non target lesions and no appearance of new lesions.|Phase 2 baseline until the date of first documented progression or discontinuation from the study due to any cause or initiation of subsequent anticancer therapy, assessed every 6 weeks up to 84 weeks|FA population, included all participants randomized with study medication assignment designated according to initial randomization, regardless of whether participants received study medication or received a different drug from that to which they were randomized.||percentage of participants||95% Confidence Interval|Number
776724|NCT00768755|Secondary|Overall Survival (OS)|Time in months from the date of randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 30.4. Death was determined from AE data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Baseline until death or collected bimonthly following discontinuation of study treatment until at least 1 year after randomization of the last participant|FA population, included all participants randomized with study medication assignment designated according to initial randomization, regardless of whether participants received study medication or received a different drug from that to which they were randomized.||months||95% Confidence Interval|Median
776736|NCT00760214|Secondary|Change From Baseline in Daytime (6am to 10 pm) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean systolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 24.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
776866|NCT00768989|Secondary|Raltegravir Tmax|Serial blood samples were collected over a 12-hour period after the morning dose at Week 2.|At Week 2 from Baseline|All randomized participants who received at least 1 dose of study medication and who were evaluable.||Hours||Full Range|Geometric Mean
776725|NCT00768755|Primary|Progression-Free Survival (PFS)|"Time in months from the date of randomization to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus minus the date of randomization plus 1) divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]); death was determined from AE data (where the outcome was Death) or from the end of study data."|Phase 2 baseline until the date of first documented progression or death due to any cause or initiation of subsequent anticancer therapy, assessed every 6 weeks up to 84 weeks|Full analysis (FA) population, included all participants randomized with study medication assignment designated according to initial randomization, regardless of whether participants received study medication or received a different drug from that to which they were randomized.||months||95% Confidence Interval|Median
776726|NCT00768898|Primary|Conjunctival Staining at 5 Minutes|"Lissamine green was instilled in each eye. Conjunctival staining was assessed by the investigator in the nasal and temporal sections. The Oxford Scheme was used for each section, with a possible score of 0-5 for each section, where 0=absent and 5=severe. The nasal and temporal scores were summed, for a possible score of 0-10 for each eye. Each subject was represented by a single eye, referred to as the study eye. The study eye was defined as the eye that attained the highest stain at any measurement time point during the screening visit."|5 minutes after instillation|Analysis conducted per protocol. All subjects participated in each arm/group.||Units on a scale||Standard Deviation|Mean
776727|NCT00768898|Primary|Conjunctival Staining at 4 Minutes|"Lissamine green was instilled in each eye. Conjunctival staining was assessed by the investigator in the nasal and temporal sections. The Oxford Scheme was used for each section, with a possible score of 0-5 for each section, where 0=absent and 5=severe. The nasal and temporal scores were summed, for a possible score of 0-10 for each eye. Each subject was represented by a single eye, referred to as the study eye. The study eye was defined as the eye that attained the highest stain at any measurement time point during the screening visit."|4 minutes after instillation|Analysis conducted per protocol. All subjects participated in each arm/group.||Units on a scale||Standard Deviation|Mean
776728|NCT00768898|Primary|Conjunctival Staining at 3 Minutes|"Lissamine green was instilled in each eye. Conjunctival staining was assessed by the investigator in the nasal and temporal sections. The Oxford Scheme was used for each section, with a possible score of 0-5 for each section, where 0=absent and 5=severe. The nasal and temporal scores were summed, for a possible score of 0-10 for each eye. Each subject was represented by a single eye, referred to as the study eye. The study eye was defined as the eye that attained the highest stain at any measurement time point during the screening visit."|3 minutes after instillation|Analysis conducted per protocol. All subjects participated in each arm/group.||Units on a scale||Standard Deviation|Mean
776729|NCT00768898|Primary|Conjunctival Staining at 2 Minutes|"Lissamine green was instilled in each eye. Conjunctival staining was assessed by the investigator in the nasal and temporal sections. The Oxford Scheme was used for each section, with a possible score of 0-5 for each section, where 0=absent and 5=severe. The nasal and temporal scores were summed, for a possible score of 0-10 for each eye. Each subject was represented by a single eye, referred to as the study eye. The study eye was defined as the eye that attained the highest stain at any measurement time point during the screening visit."|2 minutes after instillation|Analysis conducted per protocol. All subjects participated in each arm/group.||Units on a scale||Standard Deviation|Mean
776730|NCT00768898|Primary|Conjunctival Staining at 1 Minute|"Lissamine green was instilled in each eye. Conjunctival staining was assessed by the investigator in the nasal and temporal sections. The Oxford Scheme was used for each section, with a possible score of 0-5 for each section, where 0=absent and 5=severe. The nasal and temporal scores were summed, for a possible score of 0-10 for each eye. Each subject was represented by a single eye, referred to as the study eye. The study eye was defined as the eye that attained the highest stain at any measurement time point during the screening visit."|1 minute after instillation|Analysis conducted per protocol. All subjects participated in each arm/group.||Units on a scale||Standard Deviation|Mean
776731|NCT00760214|Secondary|Change From Baseline in the Trough (22-24-hr) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough mean diastolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 24.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
776732|NCT00760214|Secondary|Change From Baseline in the Trough (22-24-hr) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough mean systolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 24.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
776733|NCT00760214|Secondary|Change From Baseline in the Nighttime (12 am to 6 am) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean diastolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 24.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
776734|NCT00760214|Secondary|Change From Baseline in the Nighttime (12 am to 6 am) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean systolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 24.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
776735|NCT00760214|Secondary|Change From Baseline in Daytime (6am to 10 pm) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 24.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
791689|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Fibrinogen)||Baseline up to Month 7|||percentage of participants|||Number
776737|NCT00760214|Secondary|Change From Baseline in the 12-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring|The change in the 12-hour mean diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 24.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
776738|NCT00760214|Secondary|Change From Baseline in the 12-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring|The change in the 12-hour mean systolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 24.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
776739|NCT00760214|Secondary|Change From Baseline in 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean diastolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 24.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
776740|NCT00760214|Secondary|Change From Baseline in 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean systolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 24.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
776741|NCT00760214|Secondary|Change From Baseline in Mean Trough Clinic Sitting Diastolic Blood Pressure|The change in mean trough clinic sitting diastolic blood pressure measured at final visit or week 24 relative to baseline. Diastolic blood pressure is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements.|Baseline and Week 24.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
776742|NCT00760214|Primary|Change From Baseline in Mean Trough Clinic Sitting Systolic Blood Pressure.|The change in mean trough clinic sitting systolic blood pressure measured at final visit or week 24 relative to baseline. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.|Baseline and Week 24.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
776743|NCT00760266|Secondary|Percentage of Subjects Achieving Blood Pressure Control at Weeks 4 and 8|Blood pressure control defined as mean sitting Systolic Blood Pressure < 140 mm Hg and mean sitting Diastolic Blood Pressure < 90 mm Hg|At Weeks 4 and 8|Full analysis set||Percentage of Participants|||Number
776744|NCT00760266|Secondary|Percentage of Responders at Week 4 and Week 8|Responders defined as mean sitting Systolic Blood Pressure < 140 mmHg or reduction of ≥ 20 mmHg from baseline|At 4 weeks and 8 weeks|Full analysis set||Percentage of Participants|||Number
776745|NCT00760266|Secondary|Change in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) (in Patients With msDBP ≥90 mmHg at Baseline) From Baseline to Week 8||Baseline and Week 8|Full analysis set, restricted for msDBP to those with baseline msDBP at least 90 mm Hg)||mm Hg||Standard Error|Least Squares Mean
776746|NCT00760266|Secondary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to Week 4||Baseline and Week 4|Full analysis set, restricted to baseline msDBP >= 90 mmHg||mm Hg||Standard Error|Least Squares Mean
776747|NCT00760266|Primary|Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to Week 4||Baseline and Week 4|Full analysis set||mm Hg||Standard Error|Least Squares Mean
776748|NCT00760383|Secondary|Mid-thigh Muscle Volume|Analysis was performed using the Analyze 11 software package with semi-automated delineation of quadriceps, hamstrings, and adductors boarders. Using thresholding methods, the software can differentiate operator-delineated parameters set to distinguish muscle from non-muscle (i.e., adipose tissue) using voxel intensity within each border region for quantitative determination of muscle volume.|6 weeks|||Volume (cm^3)||Standard Error|Mean
776749|NCT00760383|Primary|Quadriceps Muscle Strength||6 weeks|||Newtons||Standard Error|Mean
776750|NCT00760383|Primary|Stair Time up||6 weeks|||seconds||Standard Error|Mean
776751|NCT00760435|Secondary|Change From Baseline in Left Anterior Descending Coronary Artery Outcomes at Week 2 by Treatment Arm|left anterior descending coronary artery Z-score; a Z score is the coronary artery adjusted for body surface area|2 weeks|||Z-score||95% Confidence Interval|Mean
776752|NCT00760435|Secondary|Change in C-reactive Protein (CRP) From Baseline at 24 Hours After Completion of Intravenous Immunoglobulin (IVIG) by Study Arm.||24 hours|||mg/dL||95% Confidence Interval|Mean
776753|NCT00760435|Secondary|Number of Days of Fever Following Therapy During Study Period (up to 6 Weeks)||up to 6 weeks|||days||Inter-Quartile Range|Median
776754|NCT00760435|Primary|The Number of Subjects in Each Arm That Have Persistent or Recrudescent Fever 24 Hours After Completion of the Intravenous Immunoglobulin (IVIG) Infusion||10 weeks|1 subject in the placebo group was removed from the modified ITT analysis (this subject was removed from the study prior to receiving the placebo)||participants|||Number
776755|NCT00760461|Primary|Gastroparesis Cardinal Symptom Index||upon study completion|Data cannot be summarized or analyzed due to the lack of data being collected on the primary outcome due to the trial being terminated.|||||
776756|NCT00760474|Secondary|Pain at the Bilateral Epicondyle Tender Points Assessed Using American College of Rheumatology (ACR) Classification Criteria|Participant rated severity of pain upon application of 4 kilograms (kg) pressure via dolorimeter at the bilateral epicondyle tender points (2 tender points, 2 centimeters distal to the epicondyles) described in the American College of Rheumatology (ACR) classification criteria and scored on a 0 (no pain) to 10 (worst possible pain) rating scale. Each arm was to be assessed for any pain (one point on each arm) with the application of pressure.|Day 58|FAS; N=number of participants with analyzable data at observation.||scores on a scale||Standard Deviation|Mean
776777|NCT00760526|Secondary|Parental Quality of Life Measures: Blood Glucose Monitoring System Rating Scale|The parent completed the following questionnaires at baseline (prior to initiating use of the blinded CGM device) and at 26 weeks: Blood Glucose Monitoring System Rating Scale. Scale 1–4. Higher score denotes fewer problems in the past month.|26 weeks|||units on a scale||Standard Deviation|Mean
776757|NCT00760474|Secondary|Sphygmomanometry Evoked Allodynia in Relation to the Blood Pressure (BP) Value at Which Allodynia Was Evoked|"BP cuff evoked allodynia assessed based on participant response to the following question When I take your blood pressure, tell me if the cuff's pressure is painful. A standard BP cuff was inflated at approximately 10 millimeters of mercury (mm Hg) per second up to 180 mm Hg or to point when participant experienced pain; performed 3 times on each arm whether or not pain was reported. If no pain elicited at 180 mm Hg, it was recorded that no sphygmomanometry-evoked allodynia occurred. If pain was reported, value (in mm Hg) at which pain first occured was recorded for each of the assessments."|Day 58|FAS; N=number of participants with analyzable data at observation.||mm Hg||Standard Deviation|Mean
776758|NCT00760474|Secondary|Short-Form McGill Pain Questionnaire (SF-MPQ): Overall Score Including Outliers|SF-MPQ was completed to assess pain over the past week and to assess present pain and consists of 15 pain descriptors: sensory dimension of pain experience (sum of items 1 to 11) and affective dimension (sum of items 12 to 15). Each descriptor was ranked by the participant on a 4-point intensity scale (0=none to 3=severe) and totaled in each subclass (sensory range 0 to 33; affective range 0 to 12). Total (overall) score was sum of items 1 to 15, range 0 to 45; higher scores indicated higher pain/impact. Any observation with a studentized residual >3 or <-3 was considered an outlier.|Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|FAS. Baseline and Post-dose data for Period 1 and Period 2 summarized as LS Mean.||scores on a scale||Standard Error|Least Squares Mean
776759|NCT00760474|Other Pre-specified|Pain Catastrophizing Scale (PCS) Including Outliers|"PCS is a participant rated 13-item instrument to measure the presence and severity of catastrophizing. Scored 0 (not at all) to 4 (all the time) to statements such as When I'm in pain…I worry all the time about whether the pain will end. All 13 statements start with When I'm in pain…. Total score ranged from 0 to 52; higher scores reflected greater impairment. Baseline and Post-dose data for Period 1 and Period 2 summarized as LS Mean. Any observation with a studentized residual >3 or <-3 was considered an outlier."|Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|FAS||scores on a scale||Standard Error|Least Squares Mean
776760|NCT00760474|Other Pre-specified|Hospital Anxiety and Depression Scale (HADS): Depression Total Score Including Outliers|A participant rated questionnaire with 2 subscales. HADS-A assessed state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assessed state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicated greater severity of anxiety and depression symptoms. Any observation with a studentized residual >3 or <-3 was considered an outlier.|Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|FAS. Baseline and Post-dose data for Period 1 and Period 2 summarized as LS Mean.||scores on a scale||Standard Error|Least Squares Mean
776761|NCT00760474|Other Pre-specified|Hospital Anxiety and Depression Scale (HADS): Anxiety Total Score Including Outliers|A participant rated questionnaire with 2 subscales. HADS-A assessed state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assessed state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicated greater severity of anxiety and depression symptoms. Any observation with a studentized residual >3 or <-3 was considered an outlier.|Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|FAS. Baseline and Post-dose data for Period 1 and Period 2 summarized as LS Mean.||scores on a scale||Standard Error|Least Squares Mean
776762|NCT00760474|Secondary|Short-Form McGill Pain Questionnaire (SF-MPQ): Sensory Total Score Including Outliers|SF-MPQ was completed to assess pain over the past week and to assess present pain and consists of 15 pain descriptors: sensory dimension of pain experience (sum of items 1 to 11) and affective dimension (sum of items 12 to 15). Each descriptor was ranked by participant on a 4-point intensity scale (0=none to 3=severe) and totaled in each subclass (sensory range 0 to 33; affective range 0 to 12); higher scores indicated higher pain/impact. Baseline and Post-dose data for Period 1 and Period 2 summarized as LS Mean. Any observation with a studentized residual >3 or <-3 was considered an outlier.|Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|FAS||scores on a scale||Standard Error|Least Squares Mean
776763|NCT00760474|Secondary|Short-Form McGill Pain Questionnaire (SF-MPQ): Affective Total Score Including Outliers|SF-MPQ was completed to assess pain over the past week and to assess present pain and consists of 15 pain descriptors: sensory dimension of pain experience (sum of items 1 to 11) and affective dimension (sum of items 12 to 15). Each descriptor was ranked by participant on a 4-point intensity scale (0=none to 3=severe) and totaled in each subclass (sensory range 0 to 33; affective range 0 to 12); higher scores indicated higher pain/impact. Baseline and Post-dose data for Period 1 and Period 2 summarized as LS Mean. Any observation with a studentized residual >3 or <-3 was considered an outlier.|Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|FAS||scores on a scale||Standard Error|Least Squares Mean
776764|NCT00760474|Secondary|Daily Pain Diary Numeric Rating Scale (NRS) Item From the Modified Brief Pain Inventory (mBPI) for Assessment of Clinical Pain: Individual Daily Pain Score Including Outliers|The daily pain diary consisted of the mBPI item regarding participant-rated average of pain over the past 24 hours. Scored on an 11-point numeric scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). The individual daily pain score was defined as the final score recorded in the last pain diary of the treatment period 24 hours prior to fMRI scanning visit. Baseline and Post-dose data for Period 1 and Period 2 summarized as LS Mean. Any observation with a studentized residual >3 or <-3 was considered an outlier.|Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|FAS||scores on a scale||Standard Error|Least Squares Mean
776765|NCT00760474|Secondary|Daily Pain Diary Numeric Rating Scale (NRS) Item From the Modified Brief Pain Inventory (mBPI) for Assessment of Clinical Pain: 3 Day Average Pain Score Including Outliers|The daily pain diary consisted of the mBPI item regarding participant-rated average of pain over the past 24 hours. Scored on an 11-point numeric scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). The 3 day average pain score was defined as the mean daily pain NRS value for the last 3 days prior to fMRI scanning visit. Baseline and Post-dose data for Period 1 and Period 2 summarized as LS Mean. Any observation with a studentized residual >3 or <-3 was considered an outlier.|Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|FAS||scores on a scale||Standard Error|Least Squares Mean
776766|NCT00760474|Secondary|Daily Pain Diary Numeric Rating Scale (NRS) Item From the Modified Brief Pain Inventory (mBPI) for Assessment of Clinical Pain: 7 Day Average Pain Score Including Outliers|The daily pain diary consisted of the mBPI item regarding participant-rated average of pain over the past 24 hours. Scored on an 11-point numeric scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). The 7 day average pain score was defined as the mean daily pain NRS value for the last 7 days prior to fMRI scanning visit. Baseline and Post-dose data for Period 1 and Period 2 summarized as LS Mean. Any observation with a studentized residual >3 or <-3 was considered an outlier.|Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|FAS||scores on a scale||Standard Error|Least Squares Mean
776767|NCT00760474|Secondary|Gracely Box Scales for Pain Unpleasantness (GBSunp) Including Outliers|Minimum and maximum pain unpleasantness acquired during resting state (no evoked pain) and during evoked pain (thumb pressure device with non-painful pressure, 2 kg pressure/equal stimulus conditions, and high pain pressure/up to 10 kg) measured during fMRI and scored from 0 (neutral) to 20 (very intolerable). Baseline and Post-dose data for Period 1 and Period 2 summarized as LS Mean. Any observation with a studentized residual >3 or <-3 was considered an outlier.|Baseline/Pre-dose (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|FAS||scores on a scale||Standard Error|Least Squares Mean
776768|NCT00760474|Secondary|Gracely Box Scales for Pain Intensity (GBSint) Including Outliers|Minimum and maximum pain intensity acquired during resting state (no evoked pain) and during evoked pain (thumb pressure device with non-painful pressure, 2 kg pressure/equal stimulus conditions, and high pain pressure/up to 10 kg) measured during fMRI and scored from 0 (no pain sensation) to 20 (extremely intense). Baseline and Post-dose data for Period 1 and Period 2 summarized as Least Squares Mean (LS Mean). Any observation with a studentized residual >3 or <-3 was considered an outlier.|Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|FAS||scores on a scale||Standard Error|Least Squares Mean
776769|NCT00760474|Secondary|Resting State Brain Activity (Connectivity Analysis) Assessed by Temporal Correlations in Low Frequency fMRI BOLD Signals Across Pain Processing Regions|Resting state brain activity assessed for correlation of brain seed region (pIns, anIns) to ROI connectivity at baseline (pre-dose) and post-dose (pre minus post) measured using z-score (mean of 0, standard deviation [SD] of 1); range approximately -3 to +3. Positive (+) z-scores reflect greater connectivity (+correlation between seed region and ROI). Negative (-) z-scores reflect -connectivity (anti-correlation between seed region and ROI). ROIs include PCC and IPL from within the default mode network (DMN). DMN is a constellation of regions in which connectivity is augmented in fibromyalgia.|Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|Participants in FAS with quality resting state data (data able to be corrected for motion [head and cardiorespiratory artifacts]).||z-score||Standard Deviation|Mean
776770|NCT00760474|Secondary|Voxel-wise Blood Oxygen Level Dependent (BOLD) Using Functional Magnetic Resonance Imaging (fMRI) of Brain Activation Signals in Response to a Control Visual (Checkerboard) Stimuli|BOLD fMRI imaging modality to assess brain activation signals across the whole brain in defined ROI brain regions in response to checkerboard visual stimuli (flashing at 8 hertz [Hz]). Reported as percent change between the pre-dose (baseline) and post-dose values.|Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|FAS.||percent change in BOLD signal||Standard Deviation|Mean
776771|NCT00760474|Primary|Voxel-wise Blood Oxygen Level Dependent (BOLD) Using Functional Magnetic Resonance Imaging (fMRI) of Brain Activation Signals in Response to Blunt Pressure Pain: Percent Change in BOLD Activations Including Outliers|BOLD fMRI imaging modality to assess brain activation signals across the whole brain in defined Region of Interest (ROI) brain regions in response to blunt pressure pain; acquired during resting state (no evoked pain) and during evoked pain (thumb pressure device with non-painful pressure, 2 kilograms [kg] pressure/equal stimulus conditions, and high pain pressure/up to 10 kg). Estimated as magnitude (percent change) of the betas representing brain signal activation associated with pressure induced pain. Any observation with a studentized residual >3 or <-3 was considered an outlier.|Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|FAS. Change from baseline for Period 1 and Period 2 summarized as Least Squares Mean (LS Mean). Abbreviation: Dorso Lateral Prefrontal Cortex (DLPFC).||percent change||Standard Error|Least Squares Mean
776772|NCT00760474|Primary|Glutamine/Creatine (Gln/Cr) and Glutamate/Creatine (Glu/Cr) Ratios Measured by Proton Magnetic Resonance Spectroscopy (1H-MRS)|Single voxel spectra obtained from the anterior and posterior right insula at rest to compare ratios for Gln/Cr, Glu/Cr, and combined Glutamate + Glutamine (Glx/Cr) for pregabalin and placebo. Gln, Glu, Glx calculated as ratios to the internal standard creatine.|Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|Full Analysis Set (FAS) all participants who received a minimum fixed dose of 300 mg/day of study treatment. N=number of participants with analyzable data at observation.||ratio||Standard Deviation|Mean
776773|NCT00760487|Secondary|IOL Rotation|Evaluation of percentage of patients that experienced rotation of the intraocular lens (IOL) less than or equal to 5 degrees from initial implantation, and less than or equal to 10 degrees from initial implantation.|6 months post-operative|||Percentage of Participants|||Number
776774|NCT00760487|Secondary|Spectacle Independence|Percentage of subjects reporting that they never wear glasses at the 6 month post-operative visit|6 months post-operative|||Percentage of participants|||Number
776775|NCT00760487|Primary|Visual Acuity (VA)|Pre-operative and 1 month, 3 month, and 6 month post-operative visual acuity (VA) measured in logMAR. LogMAR is the “logarithm of the minimum angle of resolution”. It is a unit of measure for visual acuity (VA).|Pre-operative, 1 month, 3 month, and 6 month post-operative|||logMAR||Standard Deviation|Mean
776776|NCT00760526|Secondary|Parental Quality of Life Measures: CGM Satisfaction Scale|"Parent completed the CGM satisfaction Scale at 26 weeks. Scoring based on 5-point Likert-type scale with a higher value denoting more favorable response toward CGM use (1-5 where 3 is neutral). CGM Satisfaction Scale has 2 subscales: Benefits of CGM & Lack of Hassles of CGM. For both subscales, higher value denotes more satisfaction (more perceived benefits or fewer hassles) towards CGM use. Favorable denotes agree/strongly agree with a positively worded statement or disagree/strongly disagree with a negatively worded statement. Negative denotes vice-versa. The overall score is the average of all 43 items. The subscale score is mean score of the items grouped in the subscale using factor analysis (see ref below for the details of the factor analysis)
JDRF CGM Study Group. Validation of measures of satisfaction with and impact of continuous and conventional glucose monitoring. Diabetes Technol Ther 2010;12:679–684"|26 weeks|||units on a scale||Standard Deviation|Mean
776778|NCT00760526|Secondary|Parental Quality of Life Measures: PAID (Problem Areas in Diabetes)|The parent completed the PAID survey (psychometric evaluation assessing emotional diabetes related distress)at baseline and at 26 weeks. Scale 0-100 with higher scores denoting worse condition. The results reported below are at 26 weeks.|26 weeks|||units on a scale||Standard Deviation|Mean
776779|NCT00760526|Secondary|Parental Quality of Life Measures: Hypoglycemia Fear Survey|The parent completed the following questionnaires at baseline (prior to initiating use of the blinded CGM device) and at 26 weeks: Hypoglycemia Fear Survey. Scale 0–100 with higher score denoting more fear. The results reported below are the values at 26 weeks.|26 weeks|||units on a scale||Standard Deviation|Mean
776780|NCT00760526|Secondary|Measures of Variability: Mean Amplitude of Glycemic Excursions (MAGE)|Mean amplitude of glycemic excursions (MAGE)is a measure of blood glucose variability, an indication of diabetes control. Refer to the 1970 paper by Service for a detailed explanation. Diabetes. 1970 Sep;19(9):644-55|26 weeks|CGM glucose values obtained using a blinded CGM device in the control group and unblinded device in the CGM group after the 26-week visit. Glucose indices were calculated for subjects with at least 24 h of glucose. Seven subjects in the CGM group and one subject in the control group who completed the 26-week visit were missing 26-week CGM data||percentage of median||Inter-Quartile Range|Median
776781|NCT00760526|Secondary|Measures of Variability: Mean Absolute Rate of Change|mean absolute rate of change|26 weeks|CGM glucose values obtained using a blinded CGM device in the control group and unblinded device in the CGM group after the 26-week visit. Glucose indices were calculated for subjects with at least 24 h of glucose. Seven subjects in the CGM group and one subject in the control group who completed the 26-week visit were missing 26-week CGM data||mg/dL per minute||Inter-Quartile Range|Median
776782|NCT00760526|Secondary|Measures of Variability: Standard Deviation (SD)|standard deviation (SD). Each subject has many sensor glucose values. SD was calculated for each subject as a measure of variability and the median over all subjects were reported.|26 weeks|CGM glucose values obtained using a blinded CGM device in the control group and unblinded device in the CGM group after the 26-week visit. Glucose indices were calculated for subjects with at least 24 h of glucose. Seven subjects in the CGM group and one subject in the control group who completed the 26-week visit were missing 26-week CGM data.||mg/dL||Inter-Quartile Range|Median
776783|NCT00760526|Secondary|Biochemical Hypoglycemia (Percentage of Sensor Values </= 70 mg/dL)|CGM glucose values obtained using a blinded CGM device in the control group and unblinded device in the CGM group after the 26-week visit. Glucose indices were calculated for subjects with at least 24 h of glucose. Seven subjects in the CGM group and one subject in the control group who completed the 26-week visit were missing 26-week CGM data.|26 weeks|||percentage of sensor readings||Inter-Quartile Range|Median
776784|NCT00760526|Secondary|CGM Glucose Values (mg/dL)|Percentage of sensors values in range (71 mg/dL to 180 mg/dL)|26 weeks|CGM glucose values obtained using a blinded CGM device in the control group and unblinded device in the CGM group after the 26-week visit. Glucose indices were calculated for subjects with at least 24 h of glucose. Seven subjects in the CGM group and one subject in the control group who completed the 26-week visit were missing 26-week CGM data||percentage of sensor readings||Inter-Quartile Range|Median
776785|NCT00760526|Secondary|Number of Severe Hypoglycemic Events Experienced by Participants||26 weeks|Excludes one subject in the CGM group and one subject in the control group who dropped out of the study immediately after randomization.||events|||Number
776786|NCT00760526|Primary|Number of Participants With a Decrease >=0.5% HbA1c With no Severe Hypoglycemic Events||26 weeks|Excludes five subjects in the CGM group and four in the control group who dropped out prior to the 26-week visit; for one subject who was missing central laboratory HbA1c values at randomization and one at 26 weeks, the DCA value measured at the site was used to impute values using repeated-measures regression models||participants|||Number
776787|NCT00760552|Primary|Blood Pressure Change|Participant's Blood Pressure (BP) will be measured using a standard protocol following American Heart Association guidelines using an Omron HEM 907 device. The primary endpoint—BP—will be assessed using standard measurements at baseline, 6, 12, 18, 24, and 30 months post enrollment (24 months after randomization).|Measured at Baseline, and 6,12,18,24, and 30 months post baseline.|||mmHg||Standard Deviation|Mean
776788|NCT00760578|Post-Hoc|Change From Baseline in Insulin|Change from Baseline in insulin levels following 28 days of active therapy|28 days|All patients who were compliant during the treatment period and who had a Day 8 and Day 43 pre-dose laboratory assessments. Compliance during the treatment period was determined by the sponsor through a manual review of pill counts, including a review of comments from the study sites.||uIU/mL||Standard Error|Least Squares Mean
776789|NCT00760578|Post-Hoc|Change From Baseline in FPG|Change from baseline in fasting plasma glucose (FPG) following 28 days of active therapy|28 days|All patients who were compliant during the treatment period and who had Day 8 and Day 43 fasting plasma glucose values. Compliance during the treatment period was determined by the sponsor through a manual review of pill counts, including a review of comments from the study sites.||mmol/L||Standard Error|Least Squares Mean
776790|NCT00760578|Secondary|Change From Baseline in HDL|Change from baseline in HDL following 28 days of active therapy, as part of a lipid profile assessment|28 days|All patients who were compliant during the treatment period and who had a Day 8 and Day 43 averaged mixed-meal tolerance (MMT) test and laboratory assessments. Compliance during the treatment period was determined by the sponsor through a manual review of pill counts, including a review of comments from the study sites.||mmol/L||Standard Error|Least Squares Mean
776791|NCT00760578|Secondary|Change From Baseline in Triglycerides|Change compared to baseline in triglycerides following 28 days of active therapy, as part of a lipid profile assessment|28 days|All patients who were compliant during the treatment period and who had a Day 8 and Day 43 averaged mixed-meal tolerance (MMT) test and laboratory assessments. Compliance during the treatment period was determined by the sponsor through a manual review of pill counts, including a review of comments from the study sites.||mmol/L||Standard Error|Least Squares Mean
776792|NCT00760578|Secondary|Change From Baseline in FFAs|Change from baseline in Free Fatty Acids (FFAs)following 28 days of active therapy, as part of a lipid profile assessment|After 28 days of active therapy|All patients who were compliant during the treatment period and who had a Day 8 and Day 43 averaged mixed-meal tolerance (MMT) test and laboratory assessments. Compliance during the treatment period was determined by the sponsor through a manual review of pill counts, including a review of comments from the study sites.||mmol/L||Standard Error|Least Squares Mean
776793|NCT00760578|Secondary|Change From Baseline in Averaged Insulin Levels in Response to a Mixed-meal Tolerance Test|Change from baseline in averaged post prandial insulin levels in response to a mixed-meal tolerance test.|After four weeks of active therapy|All patients who were compliant during the treatment period and who had a Day 8 and Day 43 averaged mixed-meal tolerance (MMT) test and laboratory assessments. Compliance during the treatment period was determined by the sponsor through a manual review of pill counts, including a review of comments from the study sites.||uIU/mL||Standard Error|Least Squares Mean
776794|NCT00760578|Primary|Change From Baseline in Averaged Postprandial Glucose in Response to a MMT Test|Change from baseline of averaged postprandial glucose (mmol/L) in response to a Mixed-meal tolerance (MMT) test.|28 days|All patients who were compliant during the treatment period and who had a Day 8 and Day 43 averaged mixed-meal tolerance test and laboratory assessments. Compliance during the treatment period was determined by the sponsor through a manual review of pill counts, including a review of comments from the study sites.||mmol/L||Standard Error|Least Squares Mean
776795|NCT00760617|Secondary|The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21|The markers assessed were CD4-ALL DOUBLES, CD40 Ligand (CD40L), interleukin 2 (IL-2), tumour necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ) and vaccine strains tested included A/Brisbane, A/Uruguay and B/Brisbane antigens.|At Day 0 and 21|Analysis was performed on According-to-Protocol (ATP) immunogenicity cohort for cell mediated immunity (CMI) which included subjects for whom data concerning immunogenicity CMI outcome measures were available at day 21.||cells per million CD4 T-cells||Standard Deviation|Geometric Mean
776796|NCT00760617|Secondary|The Number of Subjects Seroprotected to HI Antibodies at Day 180|Seroprotection was defined as the percentage of vaccinees with a serum HI titre ≥1:40 that usually is accepted as indicating protection. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at day 180.||subjects|||Number
776797|NCT00760617|Secondary|The Number of Subjects Seroprotected to HI Antibodies at Day 0 and Day 21|Seroprotection was defined as the percentage of vaccinees with a serum HI titre ≥1:40 that usually is accepted as indicating protection. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|At Day 0 and 21|Analysis was performed on According-to-Protocol (ATP) immunogenicity cohort for HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 21.||subjects|||Number
776798|NCT00760617|Secondary|HI Antibody SCF at Day 180|SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at day 180.||fold increase||95% Confidence Interval|Geometric Mean
776799|NCT00760617|Secondary|HI Antibody Seroconversion Factor (SCF) at Day 21|SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|Day 21|Analysis was performed on According-to-Protocol (ATP) immunogenicity cohort for HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 21.||fold increase||95% Confidence Interval|Geometric Mean
776800|NCT00760617|Secondary|The Number of Subjects Seroconverted to HI Antibodies at Day 180|Seroconversion was defined as the percentage of vaccinees who had either a pre-vaccination titre <1:10 and a post-vaccination titre ≥1:40 or a pre-vaccination titre ≥1:10 and at least a 4-fold increase in post-vaccination titre. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at day 180.||subjects|||Number
776801|NCT00760617|Secondary|The Number of Subjects Seroconverted to HI Antibodies at Day 21|Seroconversion was defined as the percentage of vaccinees who had either a pre-vaccination titre less than (<) 1:10 and a post-vaccination titre ≥1:40 or a pre-vaccination titre ≥1:10 and at least a 4-fold increase in post-vaccination titre. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|Day 21|Analysis was performed on According-to-Protocol (ATP) immunogenicity cohort for HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 21.||subjects|||Number
776802|NCT00760617|Secondary|The Number of Subjects Seropositive to HI Antibodies at Day 180|Seropositivity was defined as antibody titer greater than or equal to the cut-off value i.e ≥ 1:10. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at day 180.||subjects|||Number
776803|NCT00760617|Secondary|The Number of Subjects Seropositive to HI Antibodies at Day 0 and 21|Seropositivity was defined as antibody titer greater than or equal to the cut-off value i.e ≥ 1:10. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|At Day 0 and 21|Analysis was performed on According-to-Protocol (ATP) immunogenicity cohort for HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 21.||subjects|||Number
776804|NCT00760617|Secondary|HI Antibody Titers at Day 180|Antibody titers were expressed as GMTs with separate vaccine strains. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at day 180.||titers||95% Confidence Interval|Geometric Mean
776805|NCT00760617|Secondary|Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21|Antibody titers were expressed as Geometric mean titres (GMTs) with separate vaccine strains. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|At Day 0 and 21|Analysis was performed on According-to-Protocol (ATP) immunogenicity cohort for HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 21.||titer||95% Confidence Interval|Geometric Mean
791690|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Partial Thromboplastin Time [PTT])||Baseline up to Month 7|||percentage of participants|||Number
776806|NCT00760617|Primary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From Day 180 to Day 209|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade and related was event assessed by the investigator as causally related to the study vaccination.|Day 180 to Day 209|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
776807|NCT00760617|Primary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 21 to Day 179|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade and related was event assessed by the investigator as causally related to the study vaccination.|Day 21-179|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
776808|NCT00760617|Primary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 0 to Day 20|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade and related was event assessed by the investigator as causally related to the study vaccination.|Day 0-20|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
776809|NCT00760617|Primary|Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Disease (AID)|AESI for safety monitoring are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoiimune etiology. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as symptom that prevented normal activity and related was general symptom assessed by the investigator as possibly related to the study vaccination.|Day 0-179|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
776810|NCT00760617|Primary|Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit Between Day 21 to 179|For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as symptom that prevented normal activity and related was general symptom assessed by the investigator as possibly related to the study vaccination.|Day 21-179|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
776811|NCT00760617|Primary|Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit Between Day 0 to 20|For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as symptom that prevented normal activity and related was general symptom assessed by the investigator as possibly related to the study vaccination.|Day 0-20|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
776812|NCT00760617|Primary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs|Unsolicited adverse event (AE) covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade, grade 3 was unsolicited symptom that prevented normal activity and related was event assessed by the investigator as possibly related to the study vaccination.|Day 0-20|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
776813|NCT00760617|Primary|Duration of Solicited General AEs|Duration was defined as number of days with any grade of general symptoms.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.||Days||Full Range|Median
776814|NCT00760617|Primary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs|Any fever was defined as oral temperature ≥38.0 degree centigrade (°C), grade 3 fever was oral temperature >40.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relationship to vaccination, grade 3 was defined as a general symptom that prevented normal activity and related was a general symptom assessed by the investigator as causally related to the study vaccination.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.||subjects|||Number
776815|NCT00760617|Primary|Duration of Solicited Local AEs|Duration was defined as number of days with any grade of local symptoms and grade for quantifiable symptoms: ecchymosis, redness and swelling was greater than (>) 20mm.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.||Days||Full Range|Median
776816|NCT00760617|Primary|Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)|Grade 3 ecchymosis, redness and swelling was greater than or equal to 100 millimeter (mm) i.e. ≥ 100 mm and grade 3 pain was considerable pain at rest, that prevented normal everyday activities. Any was occurrence of any local symptom regardless of their intensity grade.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.||subjects|||Number
776867|NCT00768989|Secondary|Atazanavir Time of Maximum Observed Plasma Concentration (Tmax)|Serial blood samples were collected over a 12-hour period after the morning dose at Week 2.|At Week 2 from Baseline|All randomized participants who received at least 1 dose of study medication and who were evaluable.||Hours||Full Range|Geometric Mean
776817|NCT00760669|Primary|Number of Participants With Adverse Events (AEs) Caused by Drug Misuse, Abuse and Drug Interaction|An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Drug abuse is defined as the use of the study drug for a non-therapeutic effect, misuse was defined as use of the study medication in a way that was not prescribed and drug interaction was defined as a chemical or physiological reaction that can occur when 2 different drugs are taken together.|Baseline up to Week 30|Safety population included all participants who received at least 1 dose of study medication.||Participants|||Number
776818|NCT00760669|Primary|Number of Participants With Adverse Drug Reactions|Adverse drug reactions are defined as adverse events for which the Investigator had not described the causal relationship to trial medication as “not related”.|Baseline up to Week 30|Safety population included all participants who received at least 1 dose of study medication.||Participants|||Number
776819|NCT00760669|Primary|Number of Participants With Unexpected Adverse Events|Unexpected adverse events include those not listed in the approved product information and not described as precautions or warnings.|Baseline up to Week 30|Safety population included all participants who received at least 1 dose of study medication.||Participants|||Number
776820|NCT00760669|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to Week 30|Safety population included all participants who received at least 1 dose of study medication.||Participants|||Number
776821|NCT00760669|Primary|Overall Efficacy Assessment|The level of improvement in symptom before and after the administration of the drug was assessed as per Investigator’s discretion and the overall efficacy was assessed based on this result. The level of improvement in disease was assessed in three steps: improved, unchanged and aggravated as per Investigator's discretion.|Baseline up to Week 30|The efficacy assessment analysis set included all participants who were assessed for efficacy assessment.||Participants|||Number
776822|NCT00760669|Primary|Change From Baseline in Participants With Psoriasis Area and Severity Index (PASI) at Week 30|The PASI is combined assessment of lesion severity and area affected into single score; range: 0=no disease to 72=maximal disease. Body is divided into 4 sections (head, arms, trunk and legs); each area is scored by itself and scores were combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90 – 100%), and severity was estimated by clinical signs: erythema, thickness, and scaling; scale: 0 (none) to 4 (severe). Final PASI=sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).|Baseline and Week 30|Data was not evaluated as only 1 participant with psoriatic arthritis was enrolled in this surveillance and no PASI evaluation was done for it.|||||
776823|NCT00760669|Primary|Change From Baseline in Number of Tender Joints at Week 30|Number of tender joints was determined by examination of 28 joints and identifying when tenderness was present. The number of tender joints was recorded on the joint assessment form at each visit and scored on a scale ranging from 0 to 3, where 0=no pain, 1=mild, 2= moderate and 3=severe.|Baseline and Week 30|The efficacy assessment analysis set included all participants who were assessed for efficacy assessment. Here 'N' (number of participants analyzed) signifies the participants who were diagnosed with rheumatoid arthritis or psoriatic arthritis and were evaluated for this measure.||Tender joints||Standard Deviation|Mean
776824|NCT00760669|Primary|Change From Baseline in Number of Swollen Joints at Week 30|Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit and scored on a scale ranging from 0 to 2, where 0=no swelling, 1=swelling, but bony landmarks seen and 2=swelling but bone marks not seen.|Baseline and Week 30|The efficacy assessment analysis set included all participants who were assessed for efficacy assessment. Here 'N' (number of participants analyzed) signifies the participants who were diagnosed with rheumatoid arthritis or psoriatic arthritis and were evaluated for this measure.||Swollen joints||Standard Deviation|Mean
776825|NCT00760669|Primary|Change From Baseline in C-Reactive Protein (CRP) at Week 30|The CRP is acute serum protein released from liver. It is associated with low hemoglobin or erythropoetic resistance. The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is less than 1 milligram per deciliter (mg/dl). A decrease in the level of CRP indicated reduction in inflammation and therefore improvement.|Baseline and Week 30|The efficacy assessment analysis set included all participants who were assessed for efficacy assessment. Here 'N' (number of participants analyzed) signifies the participants who were diagnosed with rheumatoid arthritis or psoriatic arthritis and were evaluated for this measure.||Milligram per deciliter||Standard Deviation|Mean
776826|NCT00760669|Primary|Change From Baseline in Erythrocytic Sedimentation Rate (ESR) at Week 30|The ESR is a laboratory test that provides a non-specific measure of inflammation. It assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm per hour. A higher rate indicated inflammation.|Baseline and Week 30|The efficacy assessment analysis set included all participants who were assessed for efficacy assessment. Here 'N' (number of participants analyzed) signifies participants who were diagnosed with rheumatoid arthritis or psoriatic arthritis and were evaluated for this outcome measure.||Millimeter per hour||Standard Deviation|Mean
776837|NCT00760747|Secondary|Change From Baseline in Global Impression of Perceived Difficulties (GIPD) Rating Scale- Parent Total Score at Week 10 Endpoint|The GIPD scale is a 5-item rating of ADHD-related difficulties (overall difficulties perceived in the morning, during school, during homework, in the evening, and over the entire day and night). For each item, difficulties during the past week are rated on a 7-point scale (1 = normal, not difficult at all; 7 = extremely difficult) and the mean of the 5 items is reported. Least square means are adjusted for baseline, site, treatment, visit and treatment by visit interaction.|Baseline, 10 weeks|Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.||units on a scale||Standard Error|Least Squares Mean
776827|NCT00760669|Primary|Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 30|The BASDAI is a validated self-assessment tool used to assess disease activity in participants with ankylosing spondylitis. It consists of 6 items measuring fatigue, spinal pain, joint pain, areas of localized tenderness, intensity of morning stiffness and duration of morning stiffness. First 5 items are scored on a 10 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 mm=none to 10 mm=severe; and sixth item is scored on VAS ranging from 0=0 hours to 10=2 or more hours. The total BASDAI score ranges from 0 (none) to 10 (very severe).To give each symptom equal weighting, the average of the 2 scores relating to morning stiffness was taken. The resulting 0 to 50 score is divided by 5 to give a final BASDAI score. BASDAI total score = 0.2 (Item 1 + Item 2 + Item 3 + Item 4 + Item 5/2 + Item 6/2).|Baseline and Week 30|The efficacy assessment analysis set included all participants who were assessed for efficacy assessment. Here 'N' (number of participants analyzed) signifies participants who were diagnosed with ankylosing spondylitis and were evaluated for this outcome measure.||Millimeter||Standard Deviation|Mean
776828|NCT00760747|Secondary|Number of Participants With Suicidal Behaviors and Ideations|Columbia Suicide Rating Scale (C-SSRS): scale capturing occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors and ideations are provided. Suicidal behavior: a “yes” answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a “yes” answer to any one of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation.|Baseline through 14 weeks|Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.||participants|||Number
776829|NCT00760747|Secondary|Change From Baseline in Body Weight at Week 6 and Week 14 Endpoint||Baseline, 6 weeks, 14 weeks|Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment, and with both baseline and week 6 or 14 values.||kilogram||Standard Deviation|Mean
776830|NCT00760747|Primary|Change From Baseline in ADHD-RS-IV Parent Version: Investigator Administered and Scored - Total Score at Week 2 Endpoint|Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of ADHD. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. Higher score indicates greater severity of disease. Least squares means are adjusted for baseline, site, treatment, visit and treatment by visit interaction.|Baseline, 2 weeks|Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.||units on a scale||Standard Error|Least Squares Mean
776831|NCT00760747|Secondary|Change From Baseline in Pulse Rate at Week 6 and Week 14 Endpoint||Baseline, 6 weeks, 14 weeks|Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment, and with both baseline and week 6 or 14 values.||beats per minute||Standard Deviation|Mean
776832|NCT00760747|Secondary|Change From Baseline in Blood Pressure (BP) at Week 6 and Week 14 Endpoint||Baseline, 6 weeks, 14 weeks|Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment, and with both baseline and week 6 or 14 values.||mmHg||Standard Deviation|Mean
776833|NCT00760747|Secondary|Change From Baseline in Treatment Satisfaction Preference Survey Mean Score at Week 10 Endpoint|The Treatment Satisfaction Survey consists of a five-question survey each rated on a 5 point scale (0=very satisfied/very likely, 4=very dissatisfied/not at all likely). The mean score over the items is reported.|Baseline, 10 weeks|Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment. Last Observation Carried Forward (LOCF).||units on a scale||Standard Deviation|Mean
776834|NCT00760747|Secondary|Change From Baseline in Child Health and Illness Profile Child Edition-Parent Report Form (CHIP-CE-PRF) - Domain Scores at Week 10 Endpoint|CHIP-CE-PRF consists of 76 items. The majority of items assess frequency of activities or feelings using a five-point response format. Standard scores (t-value) were established, with all domains and subdomains having a mean score of 50 and standard deviation (SD) of 10. Standard scores are expressed in SD units. T-score=[(Score– Mean for the reference population [Ref Pop])*10/SD for the Ref Pop]+50. Higher scores mean better quality of life. Least square means are adjusted for baseline, site, treatment, visit and treatment by visit interaction.|Baseline, 10 weeks|Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.||standard deviation units||Standard Error|Least Squares Mean
776835|NCT00760747|Secondary|Change From Baseline in Clinical Global Impression Severity (CGI-S) Rating Scale - Total Score at Week 10 Endpoint|The CGI- S is a single-item clinician rating of the severity of the participant’s ADHD symptoms in relation to the clinician’s total experience of ADHD participants. Severity is rated on a seven-point scale (1 = normal, not ill at all; 7 = among the most extremely ill patients). Least square means are adjusted for baseline, site, treatment, visit and treatment by visit interaction.|Baseline, 10 weeks|Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.||units on a scale||Standard Error|Least Squares Mean
776836|NCT00760747|Secondary|Change From Baseline in Global Impression of Perceived Difficulties (GIPD) Rating Scale- Investigator Total Score at Week 10 Endpoint|The GIPD scale is a 5-item rating of ADHD-related difficulties (overall difficulties perceived in the morning, during school, during homework, in the evening, and over the entire day and night). For each item, difficulties during the past week are rated on a 7-point scale (1 = normal, not difficult at all; 7 = extremely difficult) and the mean of the 5 items is reported. Least square means are adjusted for baseline, site, treatment, visit and treatment by visit interaction.|Baseline, 10 weeks|Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.||units on a scale||Standard Error|Least Squares Mean
776862|NCT00768989|Secondary|Raltegravir Cmin Prior to the Morning Dose||At Week 2 from Baseline|All randomized participants who received at least 1 dose of study medication and who were evaluable.||ng•h/mL||Standard Deviation|Geometric Mean
776838|NCT00760747|Secondary|Change From Baseline in Global Impression of Perceived Difficulties (GIPD) Rating Scale - Patient Total Score at Week 10 Endpoint|The GIPD scale is a 5-item rating of ADHD-related difficulties (overall difficulties perceived in the morning, during school, during homework, in the evening, and over the entire day and night). For each item, difficulties during the past week are rated on a 7-point scale (1 = normal, not difficult at all; 7 = extremely difficult) and the mean of the 5 items is reported. Least square means are adjusted for baseline, site, treatment, visit and treatment by visit interaction.|Baseline, 10 weeks|Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.||units on a scale||Standard Error|Least Squares Mean
776839|NCT00760747|Primary|Change From Baseline in Attention Deficit Hyperactivity Disorder-Rating Scale (ADHD-RS-IV) Parent Version: Investigator Administered and Scored - Total Score at Week 10 Endpoint|Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD). Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. Higher score indicates greater severity of disease. Least squares means are adjusted for baseline, site, treatment, visit and treatment by visit interaction.|Baseline, 10 weeks|Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.||units on a scale||Standard Error|Least Squares Mean
776840|NCT00760838|Secondary|Change in Total Score on the Asthma-related Quality of Life (AQLQ)|"A disease-specific health-related quality of life instrument that taps both physical and emotional impact of disease
32 items with 2-week recall: Symptoms (11 items), Activity Limitation (12 items, 5 of which are individualized), Emotional Function (5 items), and Environmental Exposure (4 items)
7-point Likert scale (7 = not impaired at all - 1 = severely impaired).
Scores range 1-7, with higher scores indicating better quality of life."|from baseline to week 26|intention to treat analysis||units on a scale||Standard Deviation|Mean
776841|NCT00760838|Secondary|Change in Total Score on Asthma Control Questionnaire (ACQ)|"A simple questionnaire to measure the adequacy of asthma control and change in asthma control which occurs either spontaneously or as a result of treatment.
ACQ has a multidimensional construct assessing symptoms (5 items--self-administred) and rescue inbronchodilator use (1 item-self-administered), and FEV1% (1 item) completed by clinic staff
Scaling of items: 7-point scale (0=no impairment, 6= maximum impairment for symptoms and rescue use; and 7 categories for FEV1%)
Scores range between 0 (totally controlled) and 6 (severely uncontrolled)."|from baseline to week 26|intention to treat analysis||units on a scale||Standard Deviation|Mean
776842|NCT00760838|Secondary|Change in Forced Expiratory Volume in 1 Second||from baseline to week 26|intention to treat analysis||percentage of baseline FEV1||Standard Deviation|Mean
776843|NCT00760838|Secondary|Peakflow Measurements|change in peak expiratory volume peak expiratory volume is measured as a maximal expiration for 1 second|from baseline to week 26|intention to treat analysis||L/min||Standard Deviation|Mean
776844|NCT00760838|Secondary|Proportion of Participants Using Rescue Medication From Baseline to Week 26|"proportion of participants using rescue medication is defined as the the number of participants who had to use rescue medication from baseline untill week 26, independent on the number of times the medication had to be used.
This measure was conducted by averaging the proportion of participants using rescue medication from each week between baseline and week 26."|from baseline to week 26|intention to treat analysis||proportion of participants||Standard Deviation|Mean
776845|NCT00760838|Primary|Proportion of Participants With Severe Asthma Exacerbations|Severe asthma exacerbations are defined as severe asthma episodes for which a treatment with antibiotics or cortisone is administered for a minimum of 3 days.|from baseline to week 26|intention to treat analysis||proportion of participants||95% Confidence Interval|Mean
776846|NCT00760877|Secondary|Overall Survival|Overall survival was defined as the time from the date of randomization to the date of death due to any cause at any time during the study, including the follow-up period after discontinuation of treatment.|48 months|The intent-to-treat analysis set, which included all randomized participants, was analyzed.||Months||95% Confidence Interval|Median
776847|NCT00760877|Secondary|Event-free Survival|Event-free survival was defined as the time from the date of randomization to the date of first occurrence of any of the following events on study treatment: loss of complete hematological response, confirmed loss of complete cytogenetic response (CCyR), confirmed loss of major molecular response (MMR), death from any cause during treatment, progression to the accelerated phase or blast crisis of chronic myelogenous leukemia (CML) per European Leukemia Network (ELN) criteria, whichever was earliest.|48 months|The intent-to-treat analysis set, which included all randomized participants, was analyzed.||Months||95% Confidence Interval|Median
776848|NCT00760877|Secondary|Progression Free Survival (PFS)|PFS was defined as the time from the date of randomization to the date of the earliest documented progression-defining event as follows: transformation to blast crisis or accelerated phase disease, or death from any cause.|48 months|24 months, Non-responders||months||95% Confidence Interval|Median
776849|NCT00760877|Secondary|Number of Cross-over Participants With CMR|The definition of CMR is undetectable BCR-ABL (fusion gene formed between bcr gene from chromosome 22 and abl gene from chromosome 9) where BCR-ABL ratio in % international scale (IS) ≤ 0.00001 by RQ-PCR where there was no detectable BCR-ABL and 1) the test had a sensitivity of at least 4.5 logs below the standardized baseline; 2) RQ-PCR negativity was confirmed on the next RQ-PCR sample (usually 3 months later); and 3) the date of confirmed CMR was the date of the first of two negative results with sensitivity >4.5 logs.|24 months, 36 months, 48 months|Participants from the Imatinib treatment group who crossed over to the Nilotinib treatment group were analyzed.||Participants|||Number
776863|NCT00768989|Secondary|Atazanavir Cmin Prior to the Morning Dose||At Week 2 from Baseline|All randomized participants who received at least 1 dose of study medication and who were evaluable.||ng*h / mL||Standard Deviation|Geometric Mean
776864|NCT00768989|Secondary|Raltegravir Cmin 12 Hours Postdose||At Week 2 from Baseline|All randomized participants who received at least 1 dose of study medication and who were evaluable.||ng•h/mL||Standard Deviation|Geometric Mean
776865|NCT00768989|Secondary|Atazanavir Trough Plasma Concentration (Cmin) 12 Hours Postdose||At Week 2 from Baseline|All randomized participants who received at least 1 dose of study medication and who were evaluable.||ng•h/mL||Standard Deviation|Geometric Mean
776850|NCT00760877|Secondary|Rate of Confirmed Best Cumulative CMR|The rate of confirmed best cumulative CMR was defined as the number of participants who had confirmed CMR during the 24, 36 and 48 months post treatment after the randomization date. Participants who achieved confirmed best cumulative CMR during the first 12 months were considered responders. Participants who dropped out early or who did not provide sufficient data for any reason were considered to be non-responders. The definition of CMR is undetectable BCR-ABL (fusion gene formed between bcr gene from chromosome 22 and abl gene from chromosome 9) where BCR-ABL ratio in % international scale (IS) ≤ 0.00001 by RQ-PCR where there was no detectable BCR-ABL and 1) the test had a sensitivity of at least 4.5 logs below the standardized baseline; 2) RQ-PCR negativity was confirmed on the next RQ-PCR sample (usually 3 months later); and 3) the date of confirmed CMR was the date of the first of two negative results with sensitivity >4.5 logs.|24 months, 36 month, 48 months|The intent-to-treat analysis set, which included all randomized participants, was analyzed.||Participants|||Number
776851|NCT00760877|Primary|Rate of Confirmed Best Cumulative Complete Molecular Response (CMR)|The rate of confirmed best cumulative CMR was defined as the number of participants who had confirmed CMR during the first 12 months of treatment after the randomization date. Participants who achieved confirmed best cumulative CMR during the first 12 months were considered responders. Participants who dropped out early or who did not provide sufficient data for any reason were considered to be non-responders. The definition of CMR is undetectable BCR-ABL (fusion gene formed between bcr gene from chromosome 22 and abl gene from chromosome 9) where BCR-ABL ratio in % international scale (IS) ≤ 0.00001 by real-time quantitative polymerase chain reaction (RQ-PCR) where there was no detectable BCR-ABL and 1) the test had a sensitivity of at least 4.5 logs below the standardized baseline; 2) RQ-PCR negativity was confirmed on the next RQ-PCR sample (usually 3 months later); and 3) the date of confirmed CMR was the date of the first of two negative results with sensitivity >4.5 logs.|12 months|The intent-to-treat analysis set, which included all randomized participants, was analyzed.||Participants|||Number
776852|NCT00768989|Secondary|Number of Participants With Enzyme and Urine Laboratory Test Results With Worst Toxicity of Grades 1 to 4|AST/SGOT=Aspartate aminotransferase/serum glutamate oxaloacetate transaminase; ALT/SGPT=Alanine transaminase/serum glutamic pyruvic transaminase. Bilirubin (mg/dL)Gr 1: 1.1-1.5*ULN;Gr 2:1.6-2.5*ULN;Gr3:2.6-5*ULN;Gr4:>5*ULN.AST/SGOT(U/L)Gr 1:1.25-2.5*ULN;Gr 2: 2.6-5*ULN;Gr 3:5.1-10*ULN;Gr4:>10*ULN.ALT/SGPT (U/L)Gr 1:1.25-2.5*ULN;Gr 2:1.4-2.09*ULN;Gr 3:5.1-10*ULN;Gr4:>10*ULN. Lipase(U/L)Gr 1:1.1-1.39*ULN;Gr 2:>1.5-2*ULN;Gr 3:2.5-5;Gr 4:5*ULN.Proteinuria(g/24 hr loss)Gr 1:1+or <1;Gr 2:2-3+or>1-2; Gr 3:4+or>2-3.5;Gr4:>3.5.Creatine kinase(IU/L)Gr1:2-3*ULN;Gr 2:3.1-5*ULN;Gr 3:5.1-10*ULN;Gr4:>10*ULN.|While on treatment from Baseline through Week 96|All randomized participants who received at least 1 dose of study medication.||Participants|||Number
776853|NCT00768989|Secondary|Number of Participants With Blood Chemistry Laboratory Test Results With Worst Toxicity of Grades 1 to 4 (Continued)|Hyperkalemia(meq/L) Gr 1: 5.6-6; Gr 2: 6.1-6.5; Gr 3: 6.6-7; Gr4: >7. Hypokalemia(meq/L) Gr 1: 3-3.4; Gr 2: 2.5-2.9; Gr 3: 2-2.4; Gr 4:<2. Hypernatremia (meq/L) Gr 1: 148-150; Gr 2: 151-157; Gr 3: 148-165; Gr 4: >165. Hyponatremia (meq/L) Gr 1: 130-132; Gr 2: 123-129; Gr 3: 116-122; Gr 4: >115.Hyperglycemia(mg/dL)Gr 1: 116-160; Gr 2: 161-250; Gr 3: 251-500; Gr 4: >500. Hypoglycemia(mg/dL)Gr 1: 55-64; Gr 2: 40-54; Gr 3:30-39;Gr 4:<30.Creatine kinase (IU/L) Gr 1: >ULN-1.5*ULN; Gr 2: 1.5-3*ULN; Gr 3: >3-6*ULN; Gr 4: >6.0*ULN. Albumin (g/dL) Gr 1: <LLN-30; Gr 2: <30-20; Gr 3&4: <20.|While on treatment from Baseline through Week 96|All randomized participants who received at least 1 dose of study medication.||Participants|||Number
776854|NCT00768989|Secondary|Number of Participants With Blood Chemistry Laboratory Test Results With Worst Toxicity of Grades 1 to 4|Blood urea nitrogen Gr 1:1.25-2.5*ULN;Gr 2:2.6-5.0*ULN; Gr 3:5.1–10*ULN; Gr 4:>10*ULN. Creatinine (mg/dL) Gr 1: 1.1-1.5 *ULN; Gr 2: 1.6-3*ULN: Gr 3: 3.1-6*ULN; Gr 4: >6*ULN. Hypercarbia (meq/L)Gr 1: 33-36; Gr 2:37-40; Gr 3: 41-45; Gr 4:>45. Hypocarbia (meq/L)Gr 1:19-21; Gr 2: 15-18; Gr 3: 10-14; Gr 4:<10. Hypercalcemia (mg/dL)Gr 1:10.6-11.5;Gr 2:11.6-12.5; Gr 3:12.6-13.5;Gr 4: >13.5. Hypocalcemia (mg/dL)Gr 1: 8.4-7.8;Gr 2:7.7-7; Gr 3:6.9-6.1; Gr 4: <6.1.Hyperchloremia(meq/L)Gr 1:113-116; Gr 2:117-120; Gr 3:121-125; Gr 4: >125.Hypochloremia(meq/L)Gr 1: 90-93; Gr 2: 85-89; Gr 3:80-84; Gr 4:<80.|While on treatment from Baseline through Week 96|All randomized participants who received at least 1 dose of study medication.||Participants|||Number
776855|NCT00768989|Secondary|Number of Participants With Hematology Laboratory Test Results With Worst Toxicity of Grades 1 to 4 Among All Treated Participants|ULN=upper limit of normal. Hematocrit(%) Grade (Gr) 1: ≥28.5-<31; Gr 2: ≥24-<28.5; Gr 3: ≥19.5-<24; Gr 4: <19.5. Hemoglobin (g/dL) Gr 1: 9.5-11; Gr 2: 8-9.4; Gr 3: 6.5-7.9; Gr 4: <6.5. Platelets (/mm^3) Gr 1: 75,000-99,000; Gr 2: 50,000-74,999; Gr 3: 20,000-49,999; Gr 4: <20,000. White Blood Cells (/mm^3) Gr 1: >2500-4000; Gr 2: >1000-<2500; Gr 3: >800-<1000; Gr 4: <800. . Prothrombin time (seconds) Gr 1: 1.01-1.25*ULN; Gr 2: 1.26-1.5*ULN; Gr 3: 1.51-3*ULN; Gr 4: >3*ULN.|While on treatment from Baseline through Week 96|All randomized participants who received at least 1 dose of study medication.||Participants|||Number
776856|NCT00768989|Secondary|Raltegravir Terminal Elimination Half Life||At Week 2 from Baseline|All randomized participants who received at least 1 dose of study medication and who were evaluable.||Hours||Standard Deviation|Mean
776857|NCT00768989|Secondary|Atazanavir Terminal Elimination Half Life||At Week 2 from Baseline|All randomized participants who received at least 1 dose of study medication and who were evaluable.||Hours||Standard Deviation|Mean
776858|NCT00768989|Secondary|Atazanavir Individual Inhibitory Quotient (IQ)|Individual IQ was defined at Cmin at Week 2 divided by the protein binding adjusted EC90 (ie, the drug concentration observed to inhibit virion production by 90% in a cell-based assay) values for Atazanavir that were derived from individual participant clinical isolates.|At Week 2 from Baseline|All randomized participants who received at least 1 dose of study medication and who were evaluable.||Units on a Scale||Full Range|Geometric Mean
776859|NCT00768989|Secondary|Atazanavir Area Under the Concentration Curve From Time 0 to 24 Hours (AUC [0-24h]) in 1 Dosing Interval|AUC (0-24h) was estimated by multiplying AUC (0-12h) by 2.|At Week 2 from Baseline|All randomized participants who received at least 1 dose of study medication and who were evaluable.||ng•h/mL||Standard Deviation|Geometric Mean
776860|NCT00768989|Secondary|Raltegravir AUC (0-12h) in 1 Dosing Interval||At Week 2 from Baseline|All randomized participants who received at least 1 dose of study medication and who were evaluable.||ng•h/mL||Standard Deviation|Geometric Mean
776861|NCT00768989|Secondary|Atazanavir Area Under the Concentration Curve From Time 0 to 12 Hours (AUC [0-12h]) in 1 Dosing Interval||At Week 2 from Baseline|All randomized participants who received at least 1 dose of study medication and who were evaluable.||ng•h/mL||Standard Deviation|Geometric Mean
776868|NCT00768989|Secondary|Raltegravir Cmax in 1 Dosing Interval|Serial blood samples were collected over a 12-hour period after the morning dose at Week 2.|At Week 2 from Baseline|All randomized participants who received at least 1 dose of study medication and were evaluable.||ng/mL||Standard Deviation|Geometric Mean
776869|NCT00768989|Secondary|Atazanavir Maximum Observed Plasma Concentration (Cmax) in 1 Dosing Interval|Serial blood samples were collected over a 12-hour period after the morning dose at Week 2.|At Week 2 from Baseline|All randomized participants who received at least 1 dose of study medication and were evaluable.||ng/mL||Standard Deviation|Geometric Mean
776870|NCT00768989|Secondary|Mean Change From Baseline in Electrocardiogram Findings|The incidence of QRS wave widening and QT and PR prolongation on participant electrocardiogram findings were evaluated at study Week 24.|From Baseline to Week 24|All randomized participants who received at least 1 dose of study medication.||msec||Standard Error|Mean
776871|NCT00768989|Secondary|Mean Change From Baseline in Total Bilirubin Level||From Baseline to Week 24 and Week 48|All randomized participants who received at least 1 dose of study medication.||mg/dL||Standard Error|Mean
776872|NCT00768989|Secondary|Baseline and Mean Change From Baseline in Total Cholesterol Levels|The mean change from baseline in participant fasting lipids was determined using fasting serum samples.|From Baseline to Week 24 and Week 48|All randomized participants who received at least 1 dose of study medication. N=number of participants analyzed; n=number of participants with measurements for that time point.||mg/dL||Standard Error|Mean
776873|NCT00768989|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Death as Outcome, AEs Leading to Discontinuation, SAEs Leading to Discontinuation|AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in drug dependency or drug abuse, or is an important medical event.|Week 1 to Week 96, continuously|All randomized participants who received at least 1 dose of study medication.||Participants|||Number
776874|NCT00768989|Secondary|Mean Change From Baseline in Absolute Cluster of Differentiation 4 Cell Count||From Baseline to Weeks 2, 4, 8, 12, 16, 20, and 24|All randomized participants who received at least 1 dose of study medication and had baseline and timepoint results.||cells/mm^3||Standard Error|Mean
776875|NCT00768989|Secondary|Number of Participants With HIV RNA Levels <400 Copies/mL at Week 96||At Week 96 from Baseline|This analysis was not preformed due to early termination of the study.||Participants|||Number
776876|NCT00768989|Secondary|Number of Participants With HIV RNA Levels <400 Copies/mL at Week 48||At Week 48 from Baseline|The study terminated early, and this analysis was only done at Week 48 using VR-OC for participants who reached Week 48 when the study was terminated.||Participants|||Number
776877|NCT00768989|Secondary|Number of Participants With HIV RNA Levels <400 Copies/mL at Week 24|NC=F: noncompleter=failure; NC=M: noncompleter=missing; VR-OC: virologic response-observed|At Week 24 from Baseline|All randomized participants who received at least 1 dose of study medication.||Participants|||Number
776878|NCT00768989|Secondary|Number of Participants With HIV RNA Levels <50 Copies/mL at Weeks 48 and 96|Participant HIV RNA level was determined at Weeks 48 and 96 using the Roche Amplicor® Ultrasensitive Assay Version 1. VR-OC=Virologic response-observed cases.|At Weeks 48 and 96 from Baseline|The study terminated early, and this analysis was done only at Week 48 using VR-OC for participants who reached Week 48 when the study was terminated.||Participants|||Number
776879|NCT00768989|Secondary|Number of Nonresponders at Week 8|Participants were classified as nonresponders if they had an HIV RNA level ≥400 copies/mL and a decrease from baseline <2 log10 copies/mL.|At Week 8 from Baseline|The first 60 participants randomized, who received at least 1 dose of study medication.||Participants|||Number
776880|NCT00768989|Primary|Number of Participants With Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) Level <50 Copies/mL at Week 24|The number of HIV 1-infected treatment-naive participants with an HIV RNA level <50 copies/mL after 24 weeks of treatment. Confirmed virologic response noncompleter=failure (NC=F); noncompleter=missing (NC=M); virologic response-observed cases (VR-OC).|At Week 24 from Baseline|All randomized participants who received at least 1 dose of study medication.||Participants|||Number
776881|NCT00769015|Secondary|Quality of Life: Social Function|Self-reported social function was assessed using the Social Functioning subscale from the National Eye Institute Vision Function Questionaire-25 (NEI-VFQ). Scores range from 0 to 100, with higher scores indicating better social function. Changes in least square means from baseline to 4 months are presented.|4 months|||units on a scale||95% Confidence Interval|Least Squares Mean
776882|NCT00769015|Secondary|Quality of Life: Role Functioning|Self-reported role functioning was assessed using the Role Difficulties subscale from the National Eye Institute Vision Function Questionaire-25 (NEI-VFQ). Scores range from 0 to 100, with higher scores indicating fewer role difficulties . Changes in least square means from baseline to 4 months are presented.|4 months|||units on a scale||95% Confidence Interval|Least Squares Mean
776883|NCT00769015|Secondary|Quality of Life: Mental Health|Self-reported menthal health was assessed using the Mental Health subscale from the National Eye Institute Vision Function Questionaire-25 (NEI-VFQ). Scores range from 0 to 100, with higher scores indicating better mental health. Changes in least square means from baseline to 4 months are presented.|4 months|||units on a scale||95% Confidence Interval|Least Squares Mean
776884|NCT00769015|Secondary|Vision Function: Near Activities|Near vision function was assessed using the near activities subscale of the National Eye Institute Vision Function Questionaire-25 (NEI-VFQ). This subscale measures self-reported difficulty in completing activities that require near function. The subscale is scored from 0 to 100 with higher scores indicating better function. Changes in least squares mean (95% CI) from month 0 to month 4 are reported.|4 months|||units on a scale||95% Confidence Interval|Least Squares Mean
776885|NCT00769015|Secondary|Quality of Life: Dependency|Self-reported depencency was assessed using the Dependency subscale from the National Eye Institute Vision Function Questionaire-25 (NEI-VFQ). Scores range from 0 to 100, with higher scores indicating less dependency. Changes in least square means from baseline to 4 months are presented.|4 months|||units on a scale||95% Confidence Interval|Least Squares Mean
789795|NCT00867568|Secondary|AUC of TPI 287in Pediatrics Using Pharmacokinetic (PK) Testing.||Cycle 3 day 1 at Pre dose, 0 (end of infusion), 0.25, 0.5, 1, 2, 4, and 6 hours post dose|Six patients at the MTD dose of 125mg/m2/dose||ng*hr/mL||Standard Error|Mean
776886|NCT00769015|Secondary|Vision Function: Distance Activities|Distance vision function was assessed using the near activities subscale of the National Eye Institute Vision Function Questionaire-25 (NEI-VFQ). This subscale measures self-reported difficulty in completing activities that require distance function. The subscale is scored from 0 to 100 with higher scores indicating better function. Changes in least squares mean (95% CI) from month 0 to month 4 are reported.|4 months|||units on a scale||95% Confidence Interval|Least Squares Mean
776887|NCT00769015|Primary|Depression|The primary outcome was a DSM-IV diagnosis of major or minor depression based on the Patient Health Questionnaire-9 (PHQ-9).13 The PHQ-9 includes the 9 criteria that define DSM-IV diagnoses of depression and is valid in low-vision patients. A scoring algorithm determines whether the profile of symptoms meets categorical diagnoses of depression. The model is adjusted for treatment group, vision stratum (20/70 to 20/100 vs. < 20/100), baseline better eye scotoma size, baseline depression scores [Patient Health Questionnaire (PHQ-9)], Medical Outcome Study score (MOS-6), which is a global index of self-rated physical and mental health, and baseline neuroticism scores.|4 months|||participants|||Number
776888|NCT00769067|Secondary|Overall Survival (OS)|Time in weeks from randomization to date of death due to any cause. OS was calculated as (the death date or last known alive date (if death date unavailable) minus the date of randomization plus 1) divided by 7.|Baseline until end of treatment (15 August 2014); followed up every 8 weeks after discontinuation from study treatment.|ITT population included all randomized participants with study drug assignment designated according to initial randomization, regardless of treatment received.||weeks||95% Confidence Interval|Median
776889|NCT00769067|Secondary|Duration of Response (DR)|Time in weeks from first documentation of objective tumor response to objective tumor progression or symptomatic deterioration or death due to any cause, whichever occurred first. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or symptomatic deterioration or death due to any cause or last known progression-free date [if none of the event dates available] minus the date of the first CR or PR [which ever occurred first] that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Baseline until disease progression or death, assessed at Cycle 2, 3, 4, 5, 6, thereafter every other cycle up to end of treatment (121 weeks), followed by every 8 weeks >284 weeks|Analysis population included sub-set of participants from ITT population who had a confirmed objective tumor response (CR or PR).||weeks||95% Confidence Interval|Median
776890|NCT00769067|Secondary|Best Overall Response (BOR)|Number of participants with BOR according to RECIST version 1.0: CR= disappearance of all target and non-target lesions. PR= at least 30% decrease in sum of LDs of target lesion, taking as reference baseline sum LD. Stable/no response= neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of LDs since treatment started. Objective progression= at least a 20% increase in sum of LDs of target lesions, taking as reference the smallest sum of LDs recorded since treatment started and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.|Baseline until disease progression or death, assessed at Cycle 2, 3, 4, 5, 6, thereafter every other cycle up to end of treatment (121 weeks), followed by every 8 weeks >284 weeks|ITT population included all randomized participants with study drug assignment designated according to initial randomization, regardless of treatment received.||participants|||Number
776891|NCT00769067|Secondary|Percentage of Participants With Objective Response|Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.0. CR: disappearance of all target and non-target lesions. PR: at least 30 % decrease in sum of the LDs of target lesion, taking as reference the baseline sum LD. Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response.|Baseline until disease progression or death, assessed at Cycle 2, 3, 4, 5, 6, thereafter every other cycle up to end of treatment (121 weeks), followed by every 8 weeks >284 weeks|ITT population included all randomized participants with study drug assignment designated according to initial randomization, regardless of treatment received.||percentage of participants||95% Confidence Interval|Number
776892|NCT00769067|Primary|Progression-Free Survival (PFS)|PFS: Time in weeks from randomization to date of objective disease progression or death due to any cause, whichever occurred first. PFS was calculated as (first event date or last known event-free date [if the event date unavailable] minus the date of randomization plus 1) divided by 7. Objective progression is defined using Response Evaluation Criteria in Solid Tumors (RECIST), as at least 20 percent (%) increase in the sum of longest dimensions (LDs) of target lesions, taking as reference the smallest sum of LD recorded since the treatment started and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.|Baseline until disease progression or death, assessed at Cycle 2, 3, 4, 5, 6, thereafter every other cycle up to end of treatment (121 weeks), followed by every 8 weeks >284 weeks|Intent-to-treat (ITT) population included all randomized participants with study drug assignment designated according to initial randomization, regardless of treatment received.||weeks||95% Confidence Interval|Median
776893|NCT00769067|Other Pre-specified|Trough Plasma Concentration (Ctrough) of Dacomitinib (PF-00299804)|Only participants from “Dacomitinib” treatment arm were planned to be analyzed for this outcome.|C1D10-14, C2D1, C3D1, C4D1|Pharmacokinetic (PK) analysis population: all participants who received >=1 dose of study medication, with treatment assignments designated according to actual study treatment received, and from whom at least 1 PK sample was obtained. Here “n” signifies participants who were evaluable at specified time-point.||ng/mL||Standard Deviation|Mean
776894|NCT00769067|Other Pre-specified|Soluble Protein Biomarkers Level|Blood specimens were analyzed at a sponsor-designated laboratory for analysis of shed proteins/receptors related to Human Epidermal Growth Factor Receptor (HER) signaling (EGFR, HER-2, Epithelial-cadherin [E-cadherin]). The data collection after C12D1 was not performed, as there were too few participants across both treatment arms after C12D1.|Cycle (C) 1 Day (D) 1 (baseline), D1 of each subsequent cycle up to end of treatment (up to 121 weeks)|Biomarker analysis population: participants who received >=1 dose and had baseline samples submitted as per Institutional Review Board/Independent Ethics Committee approval and participant consent. “N”(number of participants analyzed): participants evaluable for this measure; “n”: participants evaluable at each time-point for each arm respectively.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
791691|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Prothrombin Time [PT])||Baseline up to Month 7|||percentage of participants|||Number
776895|NCT00769067|Other Pre-specified|Number of Participants With Kirsten Rat Sarcoma (KRAS) and Epidermal Growth Factor Receptor (EGFR) Status and EGFR T790M Mutation|Tumor tissue were analyzed at a sponsor-designated laboratory to investigate KRAS and EGFR status (wild type or mutated). Participants who did not provide samples for central laboratory analysis confirmation were classified as “unknown”. Additionally blood specimens were analyzed at a sponsor-designated laboratory for T790M mutation in EGFR.|Baseline|ITT population included all randomized participants with study drug assignment designated according to initial randomization, regardless of treatment received. The participants under the category EGFR T790M Mutation are already included in the EGFR Mutant category.||participants|||Number
776896|NCT00769067|Secondary|Dermatology Life Quality Index (DLQI)|DLQI: 10-item questionnaire to measure how much the participant’s skin problem has impacted their life over the previous week on following 6 domains: symptoms/feelings (2 questions), daily activities (2 questions), leisure (2 questions), work/school (1 question), personal relationships (2 questions), and treatment (1 question). All questions were answered on a 4-point Likert scale ranging from 0 (not at all/not relevant) to 3 (very much/prevented work or studying). The DLQI total evaluable score was calculated by summing the score of each question and ranged from 0 to 30, where higher scores indicated more quality of life impairment.|Cycle (C) 1 Day (D) 1 (baseline), C1D10-14, D1 of subsequent cycles up to C44|ITT population included all randomized participants with study drug assignment designated according to initial randomization, regardless of treatment received. Here “N” (number of participants analyzed) signifies participants evaluable for this measure; “n” signifies participants evaluable for specified category for each arm, respectively.||units on a scale||Standard Deviation|Mean
776897|NCT00769067|Secondary|Categorical Summary of Overall Scale Change in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13)|QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, other pain, and medicine for pain). Scores averaged, transformed to 0-100 scale; higher symptom score = greater degree of symptoms. Overall scale change is categorized as Improved (if average scales change from baseline <=-10), Worsened (if average scales change from baseline >=10), and Stable (if average scales change from baseline >-10 but <10) and participants in each category are reported.|Baseline up to Cycle 44 (Week 188)|ITT population: all randomized participants with study drug assignment designated according to initial randomization, regardless of treatment received. “N” (number of participants analyzed): participants who completed at least 1 item at baseline. “n”: participants evaluable for specified category for each arm, respectively.||participants|||Number
776898|NCT00769067|Secondary|Categorical Summary of Overall Scale Change in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)|EORTC QLQ-C30: included global health status/quality of life (QoL), functional (Fn) scales (physical, role, cognitive, emotional, and social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulties). Scores were averaged, transformed to 0-100 scale; higher score for Global Qol/Fn scales=better level of QoL/functioning or higher score for symptom scales/items=greater degree of symptoms. Overall scale change is categorized as Improved (if average scales change from baseline: for Global QoL/Fn scales >=10; for symptom scale/item <=-10), Worsened (if average scales change from baseline: for Global QoL/Fn scales <=-10; for symptom scale/item >=10), and Stable (if average scales change from baseline >-10 but <10 for Global QoL/Fn scales and symptom scale/item) and participants in each category are reported.|Baseline up to Cycle 44 (Week 188)|ITT population: all randomized participants with study drug assignment designated according to initial randomization, regardless of treatment received. “N” (number of participants analyzed): participants who completed at least 1 item at baseline. “n”: participants evaluable for specified category for each arm, respectively.||participants|||Number
776899|NCT00769119|Secondary|Ratio of Urine Desmosine (Total) (Normalised for Creatinine) at End of Treatment Compared to Baseline|Ratio of day 28 to baseline|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||ratio||95% Confidence Interval|Least Squares Mean
776900|NCT00769119|Secondary|Ratio of Urine Desmosine (Free) (Normalised for Creatinine) at End of Treatment Compared to Baseline|Ratio of day 28 to baseline|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||ratio||95% Confidence Interval|Least Squares Mean
776901|NCT00769119|Secondary|Ratio of Leukotriene B4 (LTB4) at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||ratio||95% Confidence Interval|Least Squares Mean
776902|NCT00769119|Secondary|Ratio of Interleukin 8 (IL-8) at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||ratio||95% Confidence Interval|Least Squares Mean
777072|NCT00770809|Secondary|Radiographic Response Rate (at Completion of Neoadjuvant Therapy)|Response was defined by the Response Evaluation Criteria in Solid Tumors (RECIST). A responding participant had either a complete response (disappearance of all target lesions) or partial response (30% decrease in sum of longest diameter of target lesions).|Week 16||||||
776903|NCT00769119|Secondary|Ratio of Monocyte Chemoattractant Protein-1 (MCP-1) at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||ratio||95% Confidence Interval|Least Squares Mean
776904|NCT00769119|Secondary|Ratio of Regulated on Activation, Normal T Cell Expressed and Secreted (RANTES) at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||ratio||95% Confidence Interval|Least Squares Mean
776905|NCT00769119|Secondary|Ratio of Interleukin 1 Beta (IL-1β) at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||ratio||95% Confidence Interval|Least Squares Mean
776906|NCT00769119|Secondary|Ratio of Interleukin 6 (IL-6) at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||ratio||95% Confidence Interval|Least Squares Mean
776907|NCT00769119|Secondary|Ratio of Tumour Necrosis Factor Alpha (TNF α) at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||ratio||95% Confidence Interval|Least Squares Mean
776908|NCT00769119|Primary|St George’s Respiratory Questionnaire for COPD Patients (SGRQ-C)|SGRQ total score shows the impact of COPD on patient's health status, and expressed as a percentage of impairment with scale from 0 (best health status) to 100 (worst possible status). Change from baseline to day 28.|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||Scores on a scale||Standard Error|Least Squares Mean
776909|NCT00769119|Primary|Bronkotest Diary Card Signs and Symptoms|The Bronkotest diary card includes 8 questions on signs and symptoms. Symptom scores were recorded for night-time symptoms, breathing, sputum colour, sputum amount, sputum type, wellbeing, and cough, generally scored on a scale from 0 (no symptoms) to 4 (worst symptoms). ANOVA models were fitted to compare the change from baseline between AZD9668 and placebo for each question separately, with a p-value of 0.1 considered statistically significant. The number of number of these 8 measures with significant differences is reported.|Last 7 days on treatment|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||events|||Number
776910|NCT00769119|Primary|Evening Peak Expiratory Flow (PEF)|Evening Peak Expiratory Flow (L/min) as a measure of lung function.Change from mean baseline value to mean of the last 7 days on treatment|Last 7 days on treatment|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L/min||Standard Error|Least Squares Mean
776911|NCT00769119|Primary|Morning Peak Expiratory Flow (PEF)|Morning Peak Expiratory Flow (L/min) as a measure of lung function.Change from mean baseline value to mean of the last 7 days on treatment|Last 7 days on treatment|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L/min||Standard Error|Least Squares Mean
776912|NCT00769119|Primary|Forced Expiratory Flow Between 25 and 75% of Forced Vital Capacity (FEF25-75%)|FEF25-75% as a measure of lung function.Change from baseline to day 28|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L/s||Standard Error|Least Squares Mean
776913|NCT00769119|Primary|Forced Vital Capacity (FVC)|Forced Vital Capacity (L) as a measure of lung function.Change from baseline to day 28|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Error|Least Squares Mean
776914|NCT00769119|Primary|Forced Expiratory Volume in 1 Second (FEV1)|Forced Expiratory Volume in 1 Second (L) as a measure of lung function.Change from baseline to day 28|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Error|Least Squares Mean
776915|NCT00769119|Primary|Slow Vital Capacity (SVC)|Slow Vital Capacity (L) as a measure of lung function.Change from baseline to day 28|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Error|Least Squares Mean
776916|NCT00769119|Primary|24-hour Sputum Weight(g)|Sputum weight (g) collected during 24 hour periods.Change from Baseline to day 28|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||g||Standard Error|Least Squares Mean
776917|NCT00769119|Primary|Ratio of the Percentage Neutrophil Count at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||ratio||95% Confidence Interval|Least Squares Mean
776918|NCT00769119|Primary|Ratio of Absolute Neutrophil Count at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||ratio||95% Confidence Interval|Least Squares Mean
776919|NCT00769132|Secondary|Prostaglandin I Metabolite (PGI-M)|The creatinine-normalized urine levels of PGI-M in the overall 24 hour collection interval following administration on Day 7.|On Day 7 across the 24-hour urinary collection period.|Twenty-six (26) subjects (including replacements) were enrolled in this study. All available subjects (besides the 4 that were excluded due suspected NSAID/Aspirin use) and had partial data (at least one available period) were included in the statistical analysis models/comparisons.||pg/mg creatinine||95% Confidence Interval|Least Squares Mean
776920|NCT00769132|Primary|Urinary 11-dehydrothromboxane B2 (11-dTxB2)|The creatinine-normalized urine levels of 11-dTxB2 on Day 7 following a 7 day course of daily dosing in the overall 24 hour collection interval.|On Day 7 across the 24-hour urinary collection period.|Twenty-six (26) subjects (including replacements) were enrolled in this study. All available subjects (besides the 4 that were excluded due suspected NSAID/Aspirin use) and had partial data (at least one available period) were included in the statistical analysis models/comparisons.||pg/mg creatinine||95% Confidence Interval|Least Squares Mean
776921|NCT00769184|Secondary|Mean Percent Improvement in Disease Severity Using PGA and OTLS Scores of Target Lesions|Mean percent improvement in disease severity using Physician Global Assessment (PGA) [PGA scale: Clear (0) - Very Severe (5)] and overall severity scores of target lesions (OTLS) [OTLS scale None (0) - Very Severe (4)] based on erythema, scaling and induration, at each visit interval.|Weeks 2, 6, & 12|All randomized patients were included in analyses. Missing scores within each study phase only were filled in by last observation carried forward.||Mean Percent Improvement||Full Range|Mean
776922|NCT00769184|Primary|Percentage of Patients Who Are Clear (PGA Score 0) or Have Minimal Disease (PGA Score 1) on Each Treated Side at Each Visit.|Those patients that have reached a PGA score of zero [PGA scale: clear (0) - very severe (5)], and are considered clear of chronic plaque psoriasis, or have reached a PGA score of 1, with minimal disease at each visit, in each condition. Data was collected at weeks 2, 6 and 12.|Weeks 2, 6, & 12.|All randomized patients were included in analyses. Missing scores within each study phase only were filled in by last observation carried forward.||percentage of participants|||Number
776923|NCT00769561|Secondary|TMD Related Symptoms|TMD related symptoms, such as jaw pain, toothache or dizziness, were measured using a 41-item TMD symptom list. Following the SOMS-7 scale, intensity of symptoms experienced during the past week was rated from 0 (‘not at all’) to 4 (‘very high intensity’) (range 0 - 164). A sum score was built with higher scores indicating higher intensity of TMD related symptoms. The TMD symptom list has not been evaluated previously; however, large bivariate correlations with somatization (Pearson’s r = .79), medium to large correlations with pain intensity (r = .48), and medium correlations with depression (r = .37) and anxiety (r = .27) provide evidence of good convergent and divergent validity. Cronbach’s alpha level in the current sample was excellent (α = .93).|Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment, and 6-months follow up|||units on a scale||Standard Deviation|Mean
776924|NCT00769561|Primary|Jaw Use Limitations (JDL)|Jaw use limitations were measured using the Jaw Disability List (JDL) from the RDC/TMD. The JDL asks the patient to rate interference with eleven oral activities, for example chewing or talking. We used an 11-point numeric rating scale (from 0 'no limitation' to 10 'maximum limitation') instead of ratings of ‘yes’ and ‘no’ (range 0 - 110). Higher values indicate higher levels of jaw use limitations. Cronbach's alpha was .86 in the current sample.|Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up|||units on a scale||Standard Deviation|Mean
776937|NCT00769704|Secondary|Duration of Response|The duration of response is defined as the longest individual period from entering response (CR or PR as assessed by the EAC) to the first documented evidence of the patient no longer meeting the criteria for being in response or death, whichever is earlier. Responses were censored at the last assessment showing response.|From randomization until the data cut-off date of 21 December 2012; median follow-up time was 20 months.|Participants with an objective response (CR or PR) per EAC assessment.||months||95% Confidence Interval|Median
776925|NCT00769561|Secondary|Pain Coping (FESV)|Cognitive and behavioral pain coping strategies were assessed with Coping Strategies Scale from the German Pain Coping Questionnaire (Fragebogen zur Erfassung der Schmerzverarbeitung, FESV). The scale asks for the use of 24 cognitive (e.g. cognitive restructuring) and behavioral (e.g. use of relaxation techniques) strategies for coping with pain on a scale ranging from 1 ('fully disagree') to 6 ('fully agree') (range 24-144). A sum score was used with higher scores indicating more adaptive coping. Cronbach’s alpha level was α = .80.|Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up|||units on a scale||Standard Deviation|Mean
776926|NCT00769561|Secondary|General Anxiety Symptoms (GAD-7)|General anxiety symptoms were assessed using the 7-item scale from the Patient Health Questionnaire (GAD-7). The GAD-7 asks for anxiety symptoms during the past month on a 1 (‘not at all’) to 3 (‘more than half of the days’) rating scale (range 7-21). Higher scores indicate higher levels of anxiety. Cronbach’s alpha level in the current sample was α = .64.|Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up|||units on a scale||Standard Deviation|Mean
776927|NCT00769561|Secondary|Depressive Symptoms (Centers for Epidemiologic Studies Depression Scale)|Depressive symptoms were measured using the Centre for Epidemiological Studies Depression scale (CES-D). The CES-D asks for the frequency of 20 symptoms of depression during the past week on a scale ranging from 0 (‘less than 1 day’) to 3 (‘5 to 7 days’) (range 0-60). Higher scores indicate more depressive symptoms. It is suitable for use in chronic pain patients as it relies less on physical symptoms of depression than do other measures. Cronbach’s alpha level in the current sample was α = .89.|Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up|||units on a scale||Standard Deviation|Mean
776928|NCT00769561|Secondary|Somatoform Symptoms (Screening for Somatoform Disorders, SOMS)|Somatoform complaints during the past week were assessed using the Screening for Somatoform Symptoms (SOMS-7). 32 medically unexplained symptoms (29 for male subjects) representing DSM-IV criteria for somatization disorder were rated on a 0 ('not at all') to 4 ('very much') scale (range 0 - 128 for women and 0 - 116 for men). A sum score was calculated with higher scores indicating higher intensity and burden of somatoform complaints. In the current sample, Cronbach’s alpha level was α = .88.|Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up|||units on a scale||Standard Deviation|Mean
776929|NCT00769561|Primary|Pain Disability (Pain Disability Index)|Pain related disability was assessed using the Pain Disability Index (PDI). The PDI is a brief self-rating scale which assesses the level of pain related disability in seven areas of daily life (e.g., social activity, self-care) on a 0 (no disability) -10 (maximum disability) numeric rating scale (range 0 - 70). Higher values indicate higher disability levels. Cronbach's alpha was .87 in the current sample.|Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up|Intent-to-treat approach (ITT) with the last observation carried forward (LOCF)||units on a scale||Standard Deviation|Mean
776930|NCT00769561|Primary|Pain Intensity (German Pain Questionnaire; Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD))|"Characteristic pain intensity (German Pain Questionnaire; Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD)):
Characteristic pain intensity was calculated by averaging ratings of current pain, average pain, and worst pain in the past month on a numeric rating scale from 0 (no pain) to 10 (maximum pain), as recommended by RDC/TMD (range 0 - 10). Higher values indicate higher pain levels."|Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up|Intent-to-treat approach (ITT) with the last observation carried forward (LOCF)||units on a scale||Standard Deviation|Mean
776931|NCT00769652|Primary|Change in Patient Generated Subjective Global Assessment (PG-SGA) Score at Time of Initial Presentation and Throughout Study||3 years|The study was closed early due to slow accrual and insufficient data was collected to analyze this outcome measure.|||||
776932|NCT00769652|Primary|Change in Weight||3 years|The study was closed early due to slow accrual and insufficient data was collected to analyze this outcome measure.|||||
776933|NCT00769652|Primary|Change in Fat Free Mass (FFM)||3 years|The study was closed early due to slow accrual and insufficient data was collected to analyze this outcome measure.|||||
776934|NCT00769704|Secondary|Response Interval|Response interval is defined as the interval between the date of randomization and the date of the last documented evidence of response (CR or PR as assessed by the Investigator) prior to any new anti-cancer therapy. Response Interval post response onset was censored if a patient was still in response at the last observation.|From randomization until the data cut-off date of 21 December 2012; median follow-up time was 20 months.|Participants with an objective response (CR or PR) per Investigator assessment.||months||95% Confidence Interval|Median
776935|NCT00769704|Secondary|Time to Treatment Failure|"Time to treatment failure was assessed by the investigator, and calculated from randomization until the first clinically relevant disease progression where there is no response achieved after the progression, or until death if no such progression occurs. Participants who did not have clinically relevant progression or did not die were censored at the time of the their last tumor assessment. Participants who withdrew from treatment due to a clinically unacceptable toxicity were not considered as an event in the analysis.
Progressive disease (PD) is defined as a ≥ 25% increase in the sum of the products of the perpendicular diameters of all measurable tumors since baseline, or the unequivocal appearance of a new tumor since the last response assessment time point.
Clinically relevant progressive disease is PD that is associated with a decline in performance status and/or in the opinion of the investigator the patient requires alternative therapy."|From randomization until the data cut-off date of 21 December 2012; median follow-up time was 20 months.|Intent to treat population||months||95% Confidence Interval|Median
776936|NCT00769704|Secondary|Response Onset|Response onset is defined as the time from the date of randomization to the date of the first documented evidence of response (CR or PR) per EAC assessment.|From randomization until the data cut-off date of 21 December 2012; median follow-up time was 20 months.|Participants with an objective response (CR or PR) per EAC assessment.||months||95% Confidence Interval|Median
776953|NCT00770029|Secondary|Responders at Maximum Frown at Day 30 by Investigator’s Rating on FWS.|The investigator’s assessment at maximum frown (frown as much as possible) on the four-point FWS: none = 0, mild = 1, moderate = 2, severe = 3. A responder was defined as a subject with a rating of none = 0 or mild = 1.|Baseline to Day 30|The number and percentage of responses by treatment group will be provided for all secondary endpoints on the FAS observed cases.||Participants|||Number
776938|NCT00769704|Secondary|Objective Response Rate|"Objective response rate was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) assessed by the Endpoint Assessment Committee (EAC). Best overall response for a patient is the best overall response observed across all time points.
Disease assessments were performed at the beginning of each treatment cycle and assessed in accordance with modified World Health Organization criteria.
CR: Disappearance of all clinical evidence of tumor (both measurable and non-measurable but evaluable disease); PR: ≥ 50% reduction in the sum of the products of the perpendicular diameters of all measurable tumors at the time of assessment as compared to baseline."|From randomization until the data cut-off date of 21 December 2012; median follow-up time was 20 months.|Intent-to-treat population||percentage of participants||95% Confidence Interval|Number
776939|NCT00769704|Secondary|Overall Survival|Overall survival was defined as the time from the date of randomization to the date of death from any cause. Overall survival time was censored at the last date the patient was known to be alive when the confirmation of death was absent or unknown. Participants were censored at the date of randomization if no additional follow-up data were obtained.|From randomization until the first 290 survival events had occurred (data cut-off date of 31 March 2014); median time on follow-up was 44 months.|Intent-to-treat population||months||95% Confidence Interval|Median
776940|NCT00769704|Primary|Durable Response Rate|"Durable response rate was defined as the percentage of participants with a complete response (CR) or partial response (PR) maintained continuously for at least 6 months from the time the objective response was first observed and initiating within 12 months of starting therapy as assessed by the Endpoint Assessment Committee (EAC). This reflects all new sites of disease as well as disease sites identified at baseline.
Disease assessments were performed at the beginning of each treatment cycle in accordance with modified World Health Organization criteria.
CR: Disappearance of all clinical evidence of tumor (both measurable and non-measurable but evaluable disease); PR: ≥ 50% reduction in the sum of the products of the perpendicular diameters of all measurable tumors at the time of assessment as compared to baseline."|From randomization until the data cut-off date of 21 December 2012; median follow-up time was 20 months.|Intent-to-treat population (all participants randomized to receive study treatment), excluding one participant who was randomized three times.||percentage of participants||95% Confidence Interval|Number
776941|NCT00769860|Secondary|Maximum Isometric Voluntary Contraction Testing (MVICT) Score|Measured MVICT using the Quantitative Muscle Assessment (QMA) system designed by Computer Source, Atlanta, GA. The system uses an adjustable cuff to attach the patient’s arm or leg to an inelastic strap that is connected to force transducer with a load of 0.5 to 1,000 Newtons. Maximum force is recorded.|Change from Baseline to Month 12|||newtons||Standard Deviation|Mean
776942|NCT00769860|Secondary|Maximum Isometric Voluntary Contraction Testing (MVICT) Score|Measured MVICT using the Quantitative Muscle Assessment (QMA) system designed by Computer Source, Atlanta, GA. The system uses an adjustable cuff to attach the patient’s arm or leg to an inelastic strap that is connected to force transducer with a load of 0.5 to 1,000 Newtons. Maximum force is recorded.|Change from Baseline to Month 8|||newtons||Standard Deviation|Mean
776943|NCT00769860|Secondary|Maximum Isometric Voluntary Contraction Testing (MVICT) Score|Measured MVICT using the Quantitative Muscle Assessment (QMA) system designed by Computer Source, Atlanta, GA. The system uses an adjustable cuff to attach the patient’s arm or leg to an inelastic strap that is connected to force transducer with a load of 0.5 to 1,000 Newtons. Maximum force is recorded.|Change from Baseline to Month 4|||newtons||Standard Deviation|Mean
776944|NCT00769860|Secondary|Inclusion Body Myositis-Functional Rating Scale (IBMFRS) Score|Measured change for the period. The questionnaire has 10 questions. The maximum score is 40. The higher the score the better the functional status of the patient.|Change from Baseline to Month 12|One of the subjects that dropped from the study in the Arimoclomol arm, returned for the 12 month visit.||units on a scale||Standard Deviation|Mean
776945|NCT00769860|Secondary|Inclusion Body Myositis-Functional Rating Scale (IBMFRS) Score|Measured change for the period. The questionnaire has 10 questions. The maximum score is 40. The higher the score the better the functional status of the patient.|Change from Baseline to Month 8|||units on a scale||Standard Deviation|Mean
776946|NCT00769860|Secondary|Inclusion Body Myositis-Functional Rating Scale (IBMFRS) Score|Measured change for the period. The questionnaire has 10 questions. The maximum score is 40. The higher the score the better the functional status of the patient.|Change from Baseline to Month 4|||units on a scale||Standard Deviation|Mean
776947|NCT00769860|Secondary|Muscle Strength Testing|Change in MMT score for the period. The MMT score range is 0-5. A score of 0 is the lowest and represents no visible or palpable contraction. A score of 5 is the highest and represents full range of motion against gravity, maximal resistance.|Change from Baseline to Month 12|||units on a scale||Standard Deviation|Mean
776948|NCT00769860|Secondary|Muscle Strength Testing|Change in MMT score for the period. The MMT score range is 0-5. A score of 0 is the lowest and represents no visible or palpable contraction. A score of 5 is the highest and represents full range of motion against gravity, maximal resistance.|Change from Baseline to Month 8|||units on a scale||Standard Deviation|Mean
776949|NCT00769860|Secondary|Muscle Strength Testing|Change in MMT score for the period. The MMT score range is 0-5. A score of 0 is the lowest and represents no visible or palpable contraction. A score of 5 is the highest and represents full range of motion against gravity, maximal resistance.|Change from Baseline to Month 4|||units on a scale||Standard Deviation|Mean
776950|NCT00769860|Secondary|Heat Shock Protein 70 (HSP70) Levels in the Tissue|Biopsy taken from participants at baseline and month 4 visits. Measured change in HSP70 levels in the tissue.|Change from Baseline to Month 4|||ng/100ng myosin||Standard Deviation|Mean
776951|NCT00769860|Primary|Count of Adverse Events Reported|Measure reflects the total number of adverse events reported during course of the study.|Month 12|||adverse events reported|||Number
776952|NCT00770029|Secondary|1-point Responders at Maximum Frown at Day 30 by Patient’s Assessment on 4-point Scale.|"Patient’s assessment at maximum frown (frown as much as possible) on the 4-point scale in comparison to sample photos: 0 = No muscle action at all; 1 = Some even slight muscle action possible i.e. visible furrows; 2 = Moderately strong muscle action possible i.e. visible muscle bulges; 3 = Strong muscle action possible which may cause local pallor.
A subject was a responder if a 1-point improvement occurred compared to baseline."|Baseline to Day 30|The number and percentage of responses by treatment group will be provided for all secondary endpoints on the FAS observed cases.||Participants|||Number
776954|NCT00770029|Secondary|1-point Responders at Rest at Day 30 by Patient’s Assessment on 4-point Scale.|"Patient’s assessment at rest (no muscle action in the face, no frown at all) on the 4-point scale in comparison to sample photos: 0 = No visible vertical line(s) at all (i.e. no visible upright line); 1 = Slightly visible vertical line(s) (i.e. slightly visible upright line); 2 = Moderate vertical line(s) with depression (i.e. upright line with deepening); 3 = Deep vertical line(s) and depression which cannot be effaced by spreading (i.e. cannot be smoothed out).
A subject was a responder if a 1-point improvement occurred compared to baseline."|Baseline to Day 30|The number and percentage of responses by treatment group will be provided for all secondary endpoints on the FAS observed cases.||Participants|||Number
776955|NCT00770029|Secondary|Responders at Rest at Day 30 by Investigator’s Rating on FWS.|The investigator’s assessment at rest (no muscle action in the face, no frown at all) on the four-point FWS: none = 0, mild = 1, moderate = 2, severe = 3. A responder was defined as a subject with a rating of none = 0 or mild = 1.|Baseline to Day 30|The number and percentage of responses by treatment group will be provided for all secondary endpoints on the FAS observed cases.||Participants|||Number
776956|NCT00770029|Primary|Composite Endpoint Treatment Success (CETS) Constituted by 2 Variables: 2-point Responders at Maximum Frown (Frown as Much as Possible) at Day 30 by Investigator's Rating on Facial Wrinkle Scale (FWS) and by Patient’s Assessment on 4-point Scale|"Composite endpoint CETS constituted by two efficacy variables:
The investigator’s assessment on the four-point FWS: none = 0, mild = 1, moderate = 2, severe = 3.
Patient’s assessment on the 4-point scale in comparison to sample photos: 0 = No muscle action at all; 1 = Some even slight muscle action possible i.e. visible furrows; 2 = Moderately strong muscle action possible i.e. visible muscle bulges; 3 = Strong muscle action possible which may cause local pallor.
A subject was a responder only if a 2-point improvement compared to baseline occurred simultaneously for both variables."|Baseline to Day 30|Full Analysis Set (FAS): All randomized subjects treated with study medication. Missing values were imputed by the evaluations made at Day 7 according to the LOCF (last observation carried forward). If no ratings for Day 7 were available values were set to ‘no 2-point responder’.||Participants|||Number
776957|NCT00770120|Secondary|Frequency and Severity of Toxicities||Weekly during the first 8 weeks of treatment, then every 4 weeks while on treatment, then every 8 weeks until disease progression, then every 6 months thereafter.|Number of Subjects With Greater Than Grade 2 Toxicity||participants|||Number
776958|NCT00770120|Secondary|Overall Survival|Overall survival was defined as the duration between the date of enrollment and the date of death due to any cause. Patients last known to be alive were censored at the date of last contact.|Every 8 weeks until disease progression, up to 3 years.|||months||95% Confidence Interval|Median
776959|NCT00770120|Secondary|Response|A response was defined as either a confirmed or unconfirmed complete or partial responses as defined by RECIST. A complete response (CR) was defined as the disappearance of all disease. A partial response (PR) was defined as a >= 30% decrease in the sum of longest diameters of target lesions. A CR or PR was considered confirmed if two consecutive determinations were made at least 4 weeks apart.|Every 8 weeks until disease progression, up to 3 years.|||percentage of overall response rate||95% Confidence Interval|Number
776960|NCT00770120|Primary|Progression-Free Survival|Progression-Free Survival was defined as the duration from the date of registration until the date of disease progression per RECIST or death due to any cause. Patients known to be alive without evidence of disease progression were censored at the date of last contact. Disease progression was defined as a >= 20% increase over nadir in the sum of longest diameters of target lesions, unequivocal progression of non-target lesions in the opinion of the treating investigator, appearance of new lesions, symptomatic deterioration, or death due to disease|Every 8 weeks until disease progression, up to 3 years.|||months||95% Confidence Interval|Median
776961|NCT00770146|Other Pre-specified|Apolipoprotein A1 at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set||mg/dL||Standard Deviation|Mean
776962|NCT00770146|Other Pre-specified|Percent Change From Baseline in Apolipoprotein A1 at the Primary Efficacy Time Point|Apolipoprotein A1 was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set||percentage of baseline||Standard Deviation|Mean
776963|NCT00770146|Other Pre-specified|Ratio of LDL Cholesterol to HDL Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set||ratio||Standard Deviation|Mean
776964|NCT00770146|Other Pre-specified|Percent Change From Baseline in the Ratio of LDL Cholesterol to HDL Cholesterol at the Primary Efficacy Time Point|The ratio of low-density lipoprotein (LDL) cholesterol to high-density lipoprotein (HDL) cholesterol was measured at Baseline and the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set||percentage of baseline||Standard Deviation|Mean
776965|NCT00770146|Other Pre-specified|Very Low Density Lipoprotein Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set||mg/dL||Inter-Quartile Range|Median
777019|NCT00770588|Secondary|Objective Tumour Response (ORR)|The objective tumour response will be calculated as the number of patients with CR or PR per RECIST Criteria. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|TTumour assessment using RECIST will be performed at baseline then every 42 days (6 weeks) ± 7 days (1 week) from randomisation until objective progression or death from any cause.|||Participants|||Number
776966|NCT00770146|Other Pre-specified|Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol at the Primary Efficacy Time Point|Very low density lipoprotein (VLDL) cholesterol was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set||percentage of baseline||Inter-Quartile Range|Median
776967|NCT00770146|Other Pre-specified|Lipoprotein (a) at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set||mg/dL||Standard Deviation|Mean
776968|NCT00770146|Other Pre-specified|Percent Change From Baseline in Lipoprotein (a) at the Primary Efficacy Time Point|Lipoprotein (a) was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set||percentage of baseline||Standard Deviation|Mean
776969|NCT00770146|Other Pre-specified|High-Density Lipoprotein Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set||mg/dL||Standard Deviation|Mean
776970|NCT00770146|Other Pre-specified|Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at the Primary Efficacy Time Point|High-density lipoprotein cholesterol (HDL-C) was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set||percentage of baseline||Standard Deviation|Mean
776971|NCT00770146|Other Pre-specified|Triglycerides at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set||mg/dL||Inter-Quartile Range|Median
776972|NCT00770146|Other Pre-specified|Percent Change From Baseline in Triglycerides at the Primary Efficacy Time Point|Triglycerides were measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set||percentage of baseline||Inter-Quartile Range|Median
776973|NCT00770146|Secondary|Non-High-Density Lipoprotein Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set||mg/dL||Inter-Quartile Range|Median
776974|NCT00770146|Secondary|Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol at the Primary Efficacy Time Point|Non-high-density lipoprotein cholesterol was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set||percentage of baseline||Inter-Quartile Range|Median
776975|NCT00770146|Secondary|Total Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set||mg/dL||Standard Deviation|Mean
776976|NCT00770146|Secondary|Percent Change From Baseline in Total Cholesterol at the Primary Efficacy Time Point|Total cholesterol was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set||percentage of baseline||Standard Deviation|Mean
776977|NCT00770146|Secondary|Apolipoprotein B at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set||mg/dL||Inter-Quartile Range|Median
776978|NCT00770146|Secondary|Percent Change From Baseline in Apolipoprotein B at the Primary Efficacy Time Point|Apolipoprotein B was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set||percentage of baseline||Inter-Quartile Range|Median
776979|NCT00770146|Primary|Low-density Lipoprotein Cholesterol (LDL-C) at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set||mg/dL||Inter-Quartile Range|Median
776980|NCT00770146|Primary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at the Primary Efficacy Time Point|LDL cholesterol was measured in mg/dL. Samples were taken following an overnight fast. LDL-C was obtained using Friedewald’s calculation for patients with triglycerides ≤400 mg/dL and was directly measured by the central laboratory using ultracentrifugation for patients with triglycerides >400 mg/dL. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|The Full Analysis Set, which consisted of all randomized patients who received at least 1 injection of study drug (mipomersen or placebo) and with a valid baseline and at least 1 post-baseline LDL-C measurement.||percentage of baseline||Inter-Quartile Range|Median
776981|NCT00770211|Secondary|1-point Responders at Maximum Frown at Day 30 by Patient’s Assessment on 4-point Scale|"Patient’s assessment at maximum frown (frown as much as possible) on the 4-point scale in comparison to sample photos: 0 = No muscle action at all; 1 = Some even slight muscle action possible i.e. visible furrows; 2 = Moderately strong muscle action possible i.e. visible muscle bulges; 3 = Strong muscle action possible which may cause local pallor.
A subject was a responder if a 1-point improvement occurred compared to baseline."|Baseline to Day 30|The number and percentage of responses by treatment group will be provided for all secondary endpoints on the FAS observed cases.||Participants|||Number
776982|NCT00770211|Secondary|Responders at Maximum Frown at Day 30 by Investigator’s Rating on FWS|The investigator’s assessment at maximum frown (frown as much as possible) on the four-point FWS: none = 0, mild = 1, moderate = 2, severe = 3. A responder was defined as a subject with a rating of none = 0 or mild = 1.|Baseline to Day 30|The number and percentage of responses by treatment group will be provided for all secondary endpoints on the FAS observed cases. Responder as having a rating of none or mild||Participants|||Number
776983|NCT00770211|Secondary|1-point Responders at Rest at Day 30 by Patient's Assessment on 4-point Scale|"Patient’s assessment at rest (no muscle action in the face, no frown at all) on the 4-point scale in comparison to sample photos: 0 = No visible vertical line(s) at all (i.e. no visible upright line); 1 = Slightly visible vertical line(s) (i.e. slightly visible upright line); 2 = Moderate vertical line(s) with depression (i.e. upright line with deepening); 3 = Deep vertical line(s) and depression which cannot be effaced by spreading (i.e. cannot be smoothed out).
A subject was a responder if a 1-point improvement occurred compared to baseline."|Baseline to Day 30|The number and percentage of responses by treatment group will be provided for all secondary endpoints on the FAS observed cases.||Participants|||Number
776984|NCT00770211|Secondary|Responders at Rest at Day 30 by Investigator's Assessment on Facial Wrinkle Scale (FWS)|The investigator’s assessment at rest (no muscle action in the face, no frown at all) on the four-point FWS: none = 0, mild = 1, moderate = 2, severe = 3. A responder was defined as a subject with a rating of none = 0 or mild = 1.|Baseline to Day 30|The number and percentage of responses by treatment group will be provided for all secondary endpoints on the FAS observed cases. Responder defined as having a rating of none or mild||Participants|||Number
776985|NCT00770211|Primary|Composite Endpoint Treatment Success (CETS) Constituted by 2 Variables: 2-point Responders at Maximum Frown (Frown as Much as Possible) at Day 30 by Investigator's Rating on the Facial Wrinkle Scale and the Patient's Assessment on 4-point Scale|"Composite endpoint CETS constituted by two efficacy variables:
The investigator’s assessment on the four-point FWS: none = 0, mild = 1, moderate = 2, severe = 3.
Patient’s assessment on the 4-point scale in comparison to sample photos: 0 = No muscle action at all; 1 = Some even slight muscle action possible i.e. visible furrows; 2 = Moderately strong muscle action possible i.e. visible muscle bulges; 3 = Strong muscle action possible which may cause local pallor.
A subject was a responder only if a 2-point improvement compared to baseline occurred simultaneously for both variables."|Baseline to Day 30|Full Analysis Set (FAS): All randomized subjects treated with study medication. Missing values were imputed by the evaluations made at Day 7 according to the LOCF (last observation carried forward). If no ratings for Day 7 were available values were set to ‘no 2-point responder’.||Particpants|||Number
776986|NCT00770289|Secondary|Number of Participants With Residual Symptoms in Case of Non Remission|Number of participants with residual symptoms who did not achieve remission was assessed. Remission according to HAM-D: HAM-D17 score =< 7 or HAM-D7 score =<3. Remission according to BDI: BDI score <10. HAM-D17: assessed 17 items associated with MD. Individual items scored on 3 point (0 to 2) or 5 point scale (0 to 4); 0=absent, 4=most severe. Total score: 0 to 66. HAM-D7: assessed 7 items associated with MD. Total score: 0 to 26. BDI assessed severity of depressive symptoms. Individual items are scored on a 4 point scale (0 to 3), with 0=none/absent and 3=most severe. The total score: 0 to 63. For all the 3 scales, higher score indicated more severe depression.|Week 12|ITT population included all enrolled participants. Here, 'N' (number of participants analyzed) signifies those participants who had data available and were evaluable for this measure.||participants|||Number
776987|NCT00770289|Secondary|Hamilton Depression Scale 17 (HAM-D17), HAM-D7 and Beck Depression Inventory (BDI)|HAM-D17: clinician-administered scale; assesses 17 items related to major depression (MD). Individual items scored on 3 point (0 to 2) or 5 point scale (0 to 4); 0=absent, 4=most severe. Total score: 0 to 66. HAM-D7: subset of HAM-D17; assesses 7 items related to MD. Total score: 0 to 26. BDI: 21 item participant rated inventory evaluates depression symptoms, cognition, physical symptoms of fatigue, weight loss, lack of interest in sex. Individual item scored on 4 point scale (0 to 3); 0=absent, 3=most severe. Total score: 0 to 63. For all the 3 scales, higher score represented more depression.|Baseline, Week 12|ITT population included all enrolled participants. Here, 'N' (number of participants analyzed) signifies those participants who had data available at baseline and were evaluable for this measure.||units on a scale||Standard Deviation|Mean
776988|NCT00770289|Secondary|Percentage of Participants With Remission Based on Beck Depression Inventory (BDI)|Remission according to BDI: BDI score less than (<) 10. BDI: 21 item participant rated inventory evaluates depression symptoms, cognition, and physical symptoms of fatigue, weight loss, lack of interest in sex. Individual items are scored on a 4 point scale (0 to 3), with 0=none/absent and 3=most severe. Total score: 0 to 63; higher score indicates more depression.|Week 12|ITT population included all enrolled participants. Here, 'N' (number of participants analyzed) signifies those participants who had data available and were evaluable for this measure.||Percentage of participants||95% Confidence Interval|Number
776989|NCT00770289|Primary|Percentage of Participants With Remission Based on Hamilton Depression Scale (HAM-D)|Remission according to HAM-D: HAM-D17 score less than or equal to (=<) 7 or a HAM-D7 score =< 3. HAM-D17: standardized, clinician-administered rating scale; assesses 17 items characteristically associated with major depression. Individual items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe. Total score: 0 to 66; higher score indicates more depression. HAM-D7: subset of HAM-D17; assesses 7 items associated with major depression. Total score: 0 to 26; higher score indicates more depression.|Week 12|Intent-to-treat (ITT) population included all enrolled participants. Here, 'N' (number of participants analyzed) signifies those participants who had data available and were evaluable for this measure.||Percentage of participants||95% Confidence Interval|Number
776990|NCT00770315|Secondary|Average Rhinoconjunctivitis DMS for the Peak RS|Rhinoconjunctivitis DMS was based on participant use of specific study-provided rescue medication, with different rescue medications being assigned different scores/dose unit (score range: 0-36), with a lower score indicating less rhinconjunctivitis medication use. Raw means were converted to adjusted means using an ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects.|The 15-day period during the ragweed season with the highest moving pollen average|The FAS population consisted of all randomized participants who took at least one dose of study medication and had at least one post-randomization efficacy measurement.||score on a scale||Standard Error|Mean
776991|NCT00770315|Secondary|Average Rhinoconjunctivitis DSS for the Entire RS|The rhinoconjunctivitis DSS consisted of a total of 6 symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes and watery eyes) that were measured on a scale of 0 to 3 (0=no symptoms, 3=severe symptoms; score range: 0-18), with a lower score indicating less rhinoconjunctivitis symptoms. Raw means were converted to adjusted means using an ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects.|Approximately 5 weeks|The FAS population consisted of all randomized participants who took at least one dose of study medication and had at least one post-randomization efficacy measurement.||score on a scale||Standard Error|Mean
776992|NCT00770315|Secondary|Average Rhinoconjunctivitis DSS for the Peak RS|The rhinoconjunctivitis DSS consisted of a total of 6 symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes and watery eyes) that were measured on a scale of 0 to 3 (0=no symptoms, 3=severe symptoms; score range: 0-18), with a lower score indicating less rhinoconjunctivitis symptoms. Raw means were converted to adjusted means using an ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects.|The 15-day period during the ragweed season with the highest moving pollen average|The FAS population consisted of all randomized participants who took at least one dose of study medication and had at least one post-randomization efficacy measurement.||score on a scale||Standard Error|Mean
776993|NCT00770315|Secondary|Average Combined Rhinoconjunctivitis DSS and DMS Over the Entire RS|The total combined score is a composite endpoint that combines the rhinoconjuntivitis DSS and the rhinoconjunctivitis DMS. The rhinoconjunctivitis DSS consisted of a total of 6 symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes and watery eyes) that were measured on a scale of 0 to 3 (0=no symptoms, 3=severe symptoms; score range: 0-18), with a lower score indicating less rhinoconjunctivitis symptoms. Rhinoconjunctivitis DMS was based on use of specific study-provided rescue medication, with different rescue medications being assigned different scores/dose unit (score range: 0-36), with a lower score indicating less rhinconjunctivitis medication use. The sum of the rhinoconjunctivitis DSS+DMS could range from 0 to 54, with a lower score indicating less rhinoconjuntivitis symptoms and medication use. Raw means were converted to adjusted means using an ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects.|Approximately 5 weeks|The FAS population consisted of all randomized participants who took at least one dose of study medication and had at least one post-randomization efficacy measurement.||score on a scale||Standard Error|Mean
776994|NCT00770315|Primary|Combined (Sum of) Rhinoconjunctivitis Daily Symptom Score (DSS) and Daily Medication Score (DMS) Averaged Over the Peak Ragweed Season (RS)|The total combined score is a composite endpoint that combines the rhinoconjuntivitis DSS and the rhinoconjunctivitis DMS. The rhinoconjunctivitis DSS consisted of a total of 6 symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes and watery eyes) that were measured on a scale of 0 to 3 (0=no symptoms, 3=severe symptoms; score range: 0-18), with a lower score indicating less rhinoconjunctivitis symptoms. Rhinoconjunctivitis DMS was based on use of specific study-provided rescue medication, with different rescue medications being assigned different scores/dose unit (score range: 0-36), with a lower score indicating less rhinconjunctivitis medication use. The sum of the rhinoconjunctivitis DSS+DMS could range from 0 to 54, with a lower score indicating less rhinoconjuntivitis symptoms and medication use. Raw means were converted to adjusted means using an ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects.|The 15-day period during the ragweed season with the highest moving pollen average|The Full Analysis Set (FAS) population consisted of all randomized participants who took at least one dose of study medication and had at least one post-randomization efficacy measurement.||score on a scale||Standard Error|Mean
777020|NCT00770588|Secondary|Overall Survival (OS)|The OS will be assessed from the time of randomisation to death from any cause. For patients not known to have died(which may include those who have been lost to follow up or who have withdrawn from the study for whatever reason), OS will be censored for the analysis at the last date at which the patients were known to be alive.|The OS will be assessed from the time of randomization to death from any cause.For patients not known to have died or who have withdrawn from the study for whatever reason,OS will be censored at the last date at which patients were known to be alive.|||month||95% Confidence Interval|Median
777001|NCT00770367|Primary|Asymmetric Dimethylarginine (ADMA) Level|Labs measured micro moles per liter of ADMA levels in participants.|3 months|Recruited 36 participants per randomization.1st analysis is serum Asymmetric Dimethylarginine ADMA at 12 weeks b/w groups.||umol/L||95% Confidence Interval|Mean
777002|NCT00770367|Secondary|NOx f2-isoprostanes|Measured oxidative stress - NOx measured by chemiluminescence detection using the Sievers NOA 280i and f2-isoprostanes are isolated by thin layer chromatography and subjected to a highly sensitive and specific gas chromatography/mass spectroscopy method to measusre the oxidative stress|3 months||12/2010||||
777003|NCT00770432|Secondary|Binary Outcomes (Bowel Movement Satisfaction, Bowel Moevement Sense of Completion).|This is not a prespecified key secondary outcome; therefore, results will not be disclosed.|24 hours to 3 days after last dose of seven day treatment period.||||||
777004|NCT00770432|Secondary|Diary Ratings in Visual Analog Scale Format (Bowel Movement Control, Gas, Bloating, Abdominal Discomfort/Cramping, Well-being)|This is not a prespecified key secondary outcome; therefore, results will not be disclosed.|24 hours to 3 days after last dose of seven day treatment period.||||||
777005|NCT00770432|Primary|Number of Participants With a Complete Resolution at the Final Visit|A resolution was recorded if the participant has no occurrence of two or more consecutive unsuccessful bowel movements for the rest of the study following the first successful bowel movement.|24 hours to 3 days after last dose of seven day treatment period.|Per-Protocol Population||Participants|||Number
777006|NCT00770484|Primary|Maximal Oxygen Consumption Capacity (VO2 Max)||Over approximately 30 minutes, within 2 hours of receiving each intervention.|||mL/kg/min||Standard Error|Mean
777007|NCT00770510|Primary|Sleep Latency (SL)|The subjective measure, SL, defined as the amount of time measured in minutes it takes to fall asleep was based on participant-reported subjective assessments of sleep disturbance and was obtained from participants' responses to morning questionnaires. Questionnaires were administered during each visit during the treatment period.|10 days (5 intervals of two consecutive nights)|Full analysis set: includes randomized participants who were administered >= 1 dose of study medication and had evaluable data for the primary efficacy assessments from any of the 5 treatment intervals.||Minutes||Standard Deviation|Mean
777008|NCT00770510|Secondary|Number of Awakenings (Objective & Subjective)|"Number of awakenings defined as the total number of spontaneous awakenings from falling asleep to final awakening was objectively determined by polysomnography and subjectively determined based on participant-reported measures following treatment.
The objective number of awakenings was based on PSG assessments. PSG recording was performed according to a manual for overnight PSG. The start time for PSG recording was individualized and scheduled within +/- 30 minutes of the participant's median bedtime as recorded in the sleep diary. PSG recording duration for scoring was 8 hours. PSG data recorded during treatment were centrally scored by a trained expert.
The subjective measure was based on participant-reported subjective assessments and were obtained from participants' responses to morning questionnaires. Questionnaires were administered during each visit during the treatment period."|10 days (5 intervals of two consecutive nights)|Full analysis set: includes randomized participants who were administered >= 1 dose of study medication and had evaluable data for the primary efficacy assessments from any of the 5 treatment intervals.||Number of awakenings||Full Range|Median
777021|NCT00770588|Primary|Progression Free Survival (PFS)|PFS will be calculated from the tumour measurements collected at each tumour assessment per the RECIST criteria and/or the date of patient death. Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline.|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first.The primary analysis of PFS will be performed when at least 265 events have occurred, which is expected to occur approximately.|||month||95% Confidence Interval|Median
777009|NCT00770510|Secondary|Wake Time After Sleep Onset (WASO)- Objective & Subjective|"Wake Time After Sleep Onset (WASO) defined as total awakening time from falling asleep to final awakening was objectively determined by polysomnography and subjectively determined based on participant-reported measures following treatment.
The objective WASO was based on PSG assessments. PSG recording was performed according to a manual for overnight PSG. The start time for PSG recording was individualized and scheduled within +/- 30 minutes of the participant's median bedtime as recorded in the sleep diary. PSG recording duration for scoring was 8 hours. PSG data recorded during treatment were centrally scored by a trained expert.
The subjective measure was based on participant-reported subjective assessments and were obtained from participants' responses to morning questionnaires. Questionnaires were administered during each visit during the treatment period."|10 days (5 intervals of two consecutive nights)|Full analysis set: includes randomized participants who were administered >= 1 dose of study medication and had evaluable data for the primary efficacy assessments from any of the 5 treatment intervals.||Minutes||Full Range|Median
777010|NCT00770510|Secondary|Sleep Efficiency|"Sleep efficiency (SE) was an assessment obtained from PSG during the treatment period and was defined as the ratio of total sleep time to the total time in bed of 8 hours * 100, expressed as a percent.
PSG recording was performed according to a manual for overnight PSG. The start time for PSG recording was individualized and scheduled within +/- 30 minutes of the patient's median bedtime as recorded in the sleep diary. During the screening period, participants were provided a diary in which they recorded the time of lights out before bedtime for 1 week pror to PSG evaluations. PSG recording duration for scoring was 8 hours. PSG data recorded during treatment were centrally scored by a trained expert."|10 days (5 intervals of two consecutive nights)|Full analysis set: includes randomized participants who were administered >= 1 dose of study medication and had evaluable data for the primary efficacy assessments from any of the 5 treatment intervals.||Percentage of time asleep of 8 hours||Full Range|Median
777011|NCT00770510|Secondary|Total Sleep Time (Objective & Subjective)|"Total sleep time defined as total sleeping time from bedtime to final awakening (measured in minutes) was objectively determined by polysomnography and subjectively determined based on participant-reported measures following treatment.
The objective total sleep time was based on PSG-based assessments. PSG recording was performed according to a manual for overnight PSG. The start time for PSG recording was individualized and scheduled within +/- 30 minutes of the participant's median bedtime as recorded in the sleep diary. PSG recording duration for scoring was 8 hours. PSG data recorded during treatment were centrally scored by a trained expert.
The subjective measure was based on participant-reported subjective assessments of sleep disturbance and were obtained from participants' responses to morning questionnaires. Questionnaires were administered during each visit during the treatment period."|10 days (5 intervals of two consecutive nights)|Full analysis set: includes randomized participants who were administered >= 1 dose of study medication and had evaluable data for the primary efficacy assessments from any of the 5 treatment intervals.||Minutes||Full Range|Median
777012|NCT00770510|Primary|Latency To Persistent Sleep (LPS)|The objective measure, LPS, defined as the amount of time measured in minutes it takes to fall asleep was based on polysomnography (PSG) objective assessments of sleep disturbance. PSG recording was performed according to a manual for overnight PSG. The start time for PSG recording was individualized and scheduled within +/- 30 minutes of the participant's median bedtime as recorded in the sleep diary. During the screening period, participants were provided a diary in which they recorded the time of lights out before bedtime for 1 week pror to PSG evaluations. PSG recording duration for scoring was 8 hours. PSG data recorded during treatment were centrally scored by a trained expert.|10 days (5 intervals of two consecutive nights)|Full analysis set: includes randomized participants who were administered >= 1 dose of study medication and had evaluable data for the primary efficacy assessments from any of the 5 treatment intervals.||Minutes||Standard Deviation|Mean
777013|NCT00770562|Secondary|Percentage of Participants With an Initial Complete Response|Initial complete response was defined as an increase in platelet count of ≥100x10^9/L by Day 30 (Week 4) after the initiation of treatment in either treatment arm.|Week 4|ITT population; excluding participants who received additional steroid therapy or IV Ig course during the first month of therapy.||percentage of participants|||Number
777014|NCT00770562|Secondary|Percentage of Participants With an Initial Response|Initial response was defined as an increase in platelet count of ≥50x10^9/L by Day 30 (Week 4) after the start of treatment in either treatment arm.|Week 4|ITT population; excluding participants who received additional steroid therapy or IV Ig course during the first month of therapy.||percentage of participants|||Number
777015|NCT00770562|Primary|Percentage of Participants With a Sustained Response|Sustained response defined as a platelet count of greater than or equal to (≥) 50x10^9/L at 6 months (Week 24) after the initial treatment. Participants failing therapy before Month 6 (Week 24) and treated in other ways were considered failures.|Week 24|The Intent-to-Treat (ITT) population includes all participants who were randomized, who received at least (<) 1 dose of study medication, and who had at least 1 follow-up contact.||percentage of participants|||Number
777016|NCT00770588|Secondary|Adverse Event|Appropriate description of AEs and laboratory data/vital signs will be produced. Number of patients who had at least one adverse events will be calculated.|AEs and SAEs must be collected from the time that the main study informed consent is obtained to 28 days after discontinuation of study drug. Any ongoing AE or SAE at discontinuation of study treatment and during 28 day follow-up period must be monitored|||Participants|||Number
777017|NCT00770588|Secondary|Symptom Improvement|Symptom improvement will be assessed from the 7-question Lung Cancer Subscale domain score derived from the FACT-L questionnaire. It is defined as an increase of two or more points on the LCS from randomization, maintained for 21 or more days. It will be calculated as the number of patients analysed with improvement.|at randomization, every 6 weeks until disease progression, and at discontinuation.|||Participants|||Number
777018|NCT00770588|Secondary|Disease Control Rate (DCR)|DCR will be calculated as the number of patients with CR, PR or sustained SD≥6 weeks per RECIST Criteria. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase|Tumour assessment using RECIST will be performed at baseline then every 42 days (6 weeks) ± 7 days (1 week) from randomisation until objective progression or death from any cause.||||||
777022|NCT00770653|Secondary|Change From Baseline in Erythrocyte Deformability (60.00).|The change between the 60.00 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from the Mainz, Germany study site. Last observation carried forward was used (LOCF) in case of premature termination.||percent||Standard Deviation|Mean
777023|NCT00770653|Secondary|Change From Baseline in Erythrocyte Deformability (30.00).|The change between the 30.00 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from the Mainz, Germany study site. Last observation carried forward was used (LOCF) in case of premature termination.||percent||Standard Deviation|Mean
777024|NCT00770653|Secondary|Change From Baseline in Erythrocyte Deformability (12.00).|The change between the 12.00 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from the Mainz, Germany study site. Last observation carried forward was used (LOCF) in case of premature termination.||percent||Standard Deviation|Mean
777025|NCT00770653|Secondary|Change From Baseline in Erythrocyte Deformability (6.00).|The change between the 6.00 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from the Mainz, Germany study site. Last observation carried forward was used (LOCF) in case of premature termination.||percent||Standard Deviation|Mean
777026|NCT00770653|Secondary|Change From Baseline in Erythrocyte Deformability (3.00).|The change between the 3.00 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from the Mainz, Germany study site. Last observation carried forward was used (LOCF) in case of premature termination.||percent||Standard Deviation|Mean
777027|NCT00770653|Secondary|Change From Baseline in Erythrocyte Deformability (1.20).|The change between the 1.20 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from the Mainz, Germany study site. Last observation carried forward was used (LOCF) in case of premature termination.||percent||Standard Deviation|Mean
777028|NCT00770653|Secondary|Change From Baseline in Erythrocyte Deformability (0.60%)|The change between the 0.60 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from the Mainz, Germany study site. Last observation carried forward was used (LOCF) in case of premature termination.||percent||Standard Deviation|Mean
777029|NCT00770653|Secondary|Change From Baseline in Erythrocyte Deformability (0.30%).|The change between the 0.30 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from the Mainz, Germany study site. Last observation carried forward was used (LOCF) in case of premature termination.||percent||Standard Deviation|Mean
777030|NCT00770653|Secondary|Change From Baseline in Von-Willebrand Factor.|The change between the value of Von-Willebrand Factor collected at week 24 or final visit and Von-Willebrand Factor collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from Schwerin, Berlin, Hanover and Münster study sites. Last observation carried forward was used (LOCF) in case of premature termination.||percent||Standard Error|Least Squares Mean
777031|NCT00770653|Secondary|Change From Baseline in E-Selectin.|The change between the value of E-Selectin collected at week 24 or final visit and E-Selectin collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from Schwerin, Berlin, Hanover and Münster study sites. Last observation carried forward was used (LOCF) in case of premature termination.||ng/mL||Standard Error|Least Squares Mean
777032|NCT00770653|Secondary|Change From Baseline in Platelet Function.|The change between the value of Platelet Function by PFA 100 collected at week 24 or final visit and Platelet Function by PFA 100 collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from the Mainz, Germany study site. Last observation carried forward was used (LOCF) in case of premature termination.||sec||Standard Error|Least Squares Mean
777033|NCT00770653|Secondary|Change From Baseline in Thromboxane B2.|The change between the value of Thromboxane B2 collected at week 24 or final visit and Thromboxane B2 collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from Schwerin, Berlin, Hanover and Münster study sites. Last observation carried forward was used (LOCF) in case of premature termination.||pg/mL||Standard Error|Least Squares Mean
777034|NCT00770653|Secondary|Change From Baseline in Soluble Vascular Cell Adhesion Molecule.|The change between the value of Soluble Vascular Cell Adhesion Molecule collected at week 24 or final visit and Soluble Vascular Cell Adhesion Molecule collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from Schwerin, Berlin, Hanover and Münster study sites. Last observation carried forward was used (LOCF) in case of premature termination.||ng/mL||Standard Error|Least Squares Mean
777035|NCT00770653|Secondary|Change From Baseline in Soluble Intracellular Adhesion Molecule.|The change between the value of Baseline in Soluble Intracellular Adhesion molecule at week 24 or final visit and Baseline in Soluble Intracellular Adhesion molecule collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from Schwerin, Berlin, Hanover and Münster study sites. Last observation carried forward was used (LOCF) in case of premature termination.||ng/mL||Standard Error|Least Squares Mean
777036|NCT00770653|Secondary|Change From Baseline in Matrix Metallo Proteinase-9.|The change between the value of Baseline in Matrix Metallo Proteinase-9 collected at week 24 or final visit and Baseline in Matrix Metallo Proteinase-9 collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from Schwerin, Berlin, Hanover and Münster study sites. Last observation carried forward was used (LOCF) in case of premature termination.||ng/mL||Standard Error|Least Squares Mean
777037|NCT00770653|Secondary|Change From Baseline in Soluble CD40 Ligand.|The change between the value of Soluble CD40 Ligand collected at week 24 or final visit and Soluble CD40 Ligand collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from Schwerin, Berlin, Hanover and Münster study sites. Last observation carried forward was used (LOCF) in case of premature termination.||pg/mL||Standard Error|Least Squares Mean
777038|NCT00770653|Secondary|Change From Baseline in Nitrotyrosine.|The change between the value of Nitrotyrosine collected at week 24 or final visit and Nitrotyrosine collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from Schwerin, Berlin, Hanover and Münster study sites. Last observation carried forward was used (LOCF) in case of premature termination.||nmol/L||Standard Error|Least Squares Mean
777039|NCT00770653|Secondary|Intake of Study Medication Greater Than 80% and Less Than 120%.|The change between the Intake of study medication greater than 80% at week 24 or final visit and Baseline and the Intake of study medication greater than 80% at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.||participants|||Number
777040|NCT00770653|Secondary|Change From Baseline in Diastolic Blood Pressure.|The change between Diastolic Blood Pressure measured at week 24 or final visit and Diastolic Blood Pressure measured at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.||mmHg||Standard Deviation|Least Squares Mean
777041|NCT00770653|Secondary|Change From Baseline in Systolic Blood Pressure.|The change between Systolic Blood Pressure measured at week 24 or final visit and Systolic Blood Pressure measured at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.||mmHg||Standard Error|Least Squares Mean
777042|NCT00770653|Secondary|Change From Baseline in High Sensitivity C-reactive Protein (≤ 10 mg/L).|The change between the value of High Sensitivity C-reactive Protein less than or equal to 10 mg/L collected at week 24 or final visit and High Sensitivity C-reactive Protein less than or equal to 10 mg/L collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.||mg/L||Standard Deviation|Mean
777043|NCT00770653|Secondary|Change From Baseline in High Sensitivity C-reactive Protein (Original).|The change between the value of High Sensitivity C-reactive Protein collected at week 24 or final visit and High Sensitivity C-reactive Protein collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.||mg/L||Standard Error|Least Squares Mean
777044|NCT00770653|Secondary|Change From Baseline in Adiponectin.|The change between Adiponectin collected at week 24 or final visit and Adiponectin collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.||μg/mL||Standard Error|Least Squares Mean
777045|NCT00770653|Secondary|Change From Baseline in Fasting Glucose.|The change between Fasting Glucose collected at week 24 or final visit and Fasting Glucose collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.||mg/dL||Standard Error|Least Squares Mean
777046|NCT00770653|Secondary|Change From Baseline in Fasting Intact Proinsulin.|The change between Fasting Intact Proinsulin collected at week 24 or final visit and Fasting Intact Proinsulin collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.||pmol/L||Standard Error|Least Squares Mean
777047|NCT00770653|Secondary|Change From Baseline in Glycosylated Hemoglobin.|The change between the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 24 or final visit and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.||mg/dL||Standard Error|Least Squares Mean
777048|NCT00770653|Secondary|Change From Baseline in Low-Density Lipoprotein Cholesterol.|The change between Low-Density Lipoprotein Cholesterol collected at week 24 or final visit and Low-Density Lipoprotein Cholesterol collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from the Mainz, Germany study site. Last observation carried forward was used (LOCF) in case of premature termination.||mg/dL||Standard Error|Least Squares Mean
777049|NCT00770653|Secondary|Change From Baseline in Low-Density Lipoprotein Subfractions.|The change between the value of Low-Density Lipoprotein Subfractions collected at week 24 or final visit and Low-Density Lipoprotein Subfractions collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from the Mainz, Germany study site. Last observation carried forward was used (LOCF) in case of premature termination.||mg/dL||Standard Error|Least Squares Mean
777050|NCT00770653|Secondary|Change From Baseline in Triglycerides.|The change between the value of Triglycerides collected at week 24 or final visit and Triglycerides collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.||mg/dL||Standard Error|Least Squares Mean
777051|NCT00770653|Secondary|Change From Baseline in High-Density Lipoprotein/Low-Density Lipoprotein Ratio.|The change between High-Density Lipoprotein/Low-Density Lipoprotein Ratio collected at week 24 or final visit and High-Density Lipoprotein/Low-Density Lipoprotein Ratio collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.||mg/dL||Standard Error|Least Squares Mean
777052|NCT00770653|Secondary|Change From Baseline in High-Density Lipoprotein Cholesterol.|The change between HDL-Cholesterol collected at week 24 or final visit and HDL-Cholesterol collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.||mg/dL||Standard Error|Least Squares Mean
777053|NCT00770653|Primary|The Mean Increase From Baseline in High-Density Lipoprotein Cholesterol.|The increase in High-Density Lipoprotein (HDL) Cholesterol collected at week 24 or final visit and HDL-Cholesterol collected at baseline.|Baseline and Week 24.|Analysis was performed on participants with at least one valid baseline and post-baseline measurement. This condition was not fulfilled in 17 participants who were excluded from the all-participants-randomized set, leading to a full-analysis-set of 288 (146 vs. 142). Last observation carried forward was used (LOCF) in case of premature termination.||mg/dL||Standard Error|Least Squares Mean
777054|NCT00770679|Primary|Change in Endothelial Function as Measured on MRI in the Legs||chance from baseline to end of study, up to 5 weeks|No data was collected for this outcome measure. The outcome was not able to be calculated based upon data obtained and programs and investigator capabilities.|||||
777055|NCT00770679|Primary|Change in Endothelial Function as Measured on MRI in the Arms||chance from baseline to end of study, up to 5 weeks|No data was collected for this outcome measure. The outcome was not able to be calculated based upon data obtained and programs and investigator capabilities.|||||
777056|NCT00770679|Primary|Mean Change in Low Density Lipoprotein (LDL)|Serum LDL, mg/dL (baseline LDL-follow-up LDL)|Change from baseline to follow-up, up to 5 weeks|3 participants were lost to follow-up, 3 participants did not have LDL values collected/reported at follow-up||mg/dL||Standard Deviation|Mean
777057|NCT00770692|Secondary|Mean Change From Baseline in Total Number of Awakenings|Based on subjective symptoms, the participants recorded their number of awakenings defined as total number of spontaneous awakenings from falling asleep to final awakening in a sleep diary questionnaire for the week preceding the start of the study treatment (the day on which the patient was enrolled in the treatment period), as well as between the day on which the study treatment started and the Week 4 visit. For pre-treatment (screening period), the representative value was calculated from the data of the 7 days preceding enrollment in the treatment period. A median of all the data between the day of enrollment in the treatment period and the day before dose escalation judgment was presented as the data of the overall period. The change was calculated as the total number of awakenings of the overall period assessment - total number of awakenings at baseline (screening period).|Baseline (screening period) and 4 weeks of treatment|Efficacy analysis set: all of the 161 non-elderly participants who were enrolled in the treatment period. Among the 164 elderly participants who were enrolled in the treatment period, 163 (80 in the 1 mg group and 83 in the 2 mg group) were included in the efficacy set, excluding 1 participant in the 1 mg group who had no evaluable efficacy data.||Number of Awakenings||Standard Deviation|Mean
777058|NCT00770692|Secondary|Mean Change From Baseline in Total Sleep Time|Based on subjective symptoms, the participants recorded their total sleep time defined as total sleeping time from bedtime to final awakening in a sleep diary questionnaire for the week preceding the start of the study treatment (the day on which the patient was enrolled in the treatment period), as well as between the day on which the study treatment started and the Week 4 visit. For pre-treatment (screening period), the representative value was calculated from the data of the 7 days preceding enrollment in the treatment period. A median of all the data between the day of enrollment in the treatment period and the day before dose escalation judgment was presented as the data of the overall period. The change was calculated as the total sleep time of the overall period assessment - total sleep time at baseline (screening period).|Baseline (screening period) and 4 weeks of treatment|Efficacy analysis set: all of the 161 non-elderly participants who were enrolled in the treatment period. Among the 164 elderly participants who were enrolled in the treatment period, 163 (80 in the 1 mg group and 83 in the 2 mg group) were included in the efficacy set, excluding 1 participant in the 1 mg group who had no evaluable efficacy data.||minutes||Standard Deviation|Mean
777069|NCT00770809|Secondary|Time to First Failure|Time to first failure is defined as the interval from study entry to ipsilateral invasive breast tumor recurrence, regional invasive breast cancer recurrence, distant recurrence or death from any cause. Patients who have not experienced any of these events will be censored at the date of last clinical assessment. Distribution was estimated using the Kaplan Meier product-limit method.|Time from study entry to any recurrence ( up to 10 years)||||||
777070|NCT00770809|Secondary|Relapse-free Survival (RFS)|Relapse free survival is defined as the interval from definitive surgery to ipsilateral invasive breast tumor recurrence, regional invasive breast cancer recurrence, distant recurrence, or death from any cause, whichever occurs first. Patients who have not experienced any of these events will be censored at the date of last clinical assessment. Patients who do not undergo definitive surgery will not be assessable for RFS. Distribution was estimated using the Kaplan Meier product-limit method.|Time from surgery to any recurrence (up to 10 years)||||||
777059|NCT00770692|Secondary|Mean Change From Baseline in Wake Time After Sleep Onset (WASO)|Based on subjective symptoms, the participants recorded their WASO defined as total awakening time from falling asleep to final awakening in a sleep diary questionnaire for the week preceding the start of the study treatment (the day on which the patient was enrolled in the treatment period), as well as between the day on which the study treatment started and the Week 4 visit. For pre-treatment (screening period), the representative value was calculated from the data of the 7 days preceding enrollment in the treatment period. A median of all the data between the day of enrollment in the treatment period and the day before dose escalation judgment was presented as the data of the overall period. The change was calculated as the WASO of the overall period assessment - WASO at baseline (screening period).|Baseline (screening period) and 4 weeks of treatment|Efficacy analysis set: all of the 161 non-elderly participants who were enrolled in the treatment period. Among the 164 elderly participants who were enrolled in the treatment period, 163 (80 in the 1 mg group and 83 in the 2 mg group) were included in the efficacy set, excluding 1 participant in the 1 mg group who had no evaluable efficacy data.||minutes||Standard Deviation|Mean
777060|NCT00770692|Primary|Incidence of Adverse Events|"Incidence of adverse events was defined as: (number of participants with adverse events/ number of participants analyzed in the safety analysis set)*100.
An adverse event was defined as any unwanted or untoward disease or its symptom, sign, or abnormality in laboratory parameters in a subject who receives a study drug. An adverse event does not necessarily have a causal relationship with the study drug. The investigator or subinvestigator evaluated adverse events and recorded the results in the case report form (CRF). The investigator or subinvestigator recorded all adverse events occurring after the start of study treatment in the CRF, irrespective of the causal relationship with the study drug or the study procedures. All data collected from the follow-up was recorded in CRF."|Up to 25 weeks (24 weeks treatment period & 1 week follow-up)|Safety analysis set: All 161 non-elderly participants who were enrolled in the treatment period were included. All 164 elderly patients who were enrolled in the treatment period were included. The participant who was excluded from the efficacy analysis set was included in the safety analysis set because the participant had evaluable safety data.||Percentage of Participants|||Number
777061|NCT00770692|Secondary|Mean Change From Baseline In Sleep Latency|Based on subjective symptoms, the participants recorded their sleep latency (the amount of time measured in minutes it takes to fall asleep) in a sleep diary questionnaire for the week preceding the start of the study treatment (the day on which the patient was enrolled in the treatment period), as well as between the day on which the study treatment started and the Week 4 visit. For pre-treatment (screening period), the representative value was calculated from the data of the 7 days preceding enrollment in the treatment period. A median of all the data between the day of enrollment in the treatment period and the day before dose escalation judgment was presented as the data of the overall period. The change was calculated as the sleep latency of the overall period assessment - sleep latency at baseline (screening period).|Baseline (screening period) and 4 weeks of treatment|Efficacy analysis set: all of the 161 non-elderly participants who were enrolled in the treatment period. Among the 164 elderly participants who were enrolled in the treatment period, 163 (80 in the 1 mg group and 83 in the 2 mg group) were included in the efficacy set, excluding 1 participant in the 1 mg group who had no evaluable efficacy data.||minutes||Standard Deviation|Mean
777062|NCT00770757|Post-Hoc|Survival Rate of CC-4047 Responders||Median follow-up 5.6 years (4.2-5.6 years)|Five participants have died and these were the participants who did not respond or were removed from study prior to cycle 3 due to adverse events.||percentage of participants|||Number
777063|NCT00770757|Post-Hoc|Chronic Graft-versus-host Disease Global Score at the Start/End of the Study|"Global scoring of chronic GvHD consists of questions about various organs including skin, genital tract, lungs, liver, and multiple others. The physician scores each organ from 0 to 3. Score 0 means the patient has no symptoms. Score 1 means the patient has mild symptoms. Score 2 means the patient has moderate symptoms. Score 3 means the patient has severe syptoms.
Mild scoring of chronic GvHD is only 1 or 2 organs or site (except the lung). No clinically significant functional impairment (maximum of score 1 in all affected organs or sites)
Moderate scoring of chronic GvHD is at least 1 organ or site with clinically significant but no major disability (maximum score of 2 in any affected organ or site) or 3 or more organs or sites with no clinically significant functional impairment (maximum of 1 in all affected orgnas or sites)
Severe scoring of chronic GvHD is a major disability caused by chronic GvHD (score of 3 in any organ or site) and lung function score >=2."|1 year after last dose of CC-4047|||participants|||Number
777064|NCT00770757|Post-Hoc|Organ System Response||1 year after last dose of CC-4047|4 participants discontinued treatment before the third cycle because of adverse-effects and were not evaluable||participants|||Number
777065|NCT00770757|Secondary|Safety as Measured by the Most Common Adverse Effects and Reasons for Dose Reductions or Study-discontinuation|-Toxicities will be graded according to the NCI CTCAE v3.0.|30 days after last dose of CC-4047 or until resolution of event|||participants|||Number
777066|NCT00770757|Primary|Overall Response (Complete Response + Partial Response + Other)|"CR is defined as complete resolution in all of signs and symptoms at all affected organs and tissues
PR is defined as improvement in greater than or equal to 1 organ/tissue with no progression in any other affected organ/tissue
Improvement in chronic GvHD symptoms less than what meets the definition of a PR is defined as other
Progressive disease is defined as failure of therapy to control chronic GvHD despite increasing the dose of primary therapy or adding second line treatments
No response is defined as no change in disease."|1 year after last dose of CC-4047|4 participants discontinued treatment before the third cycle because of adverse-effects and were not evaluable||participants|||Number
777067|NCT00770770|Primary|Visual Acuity|To compare the 3 month best corrected visual acuity to baseline in subjects diagnosed with macular edema secondary to retinal vein occlusion. BCVA will be measured according to the standard procedure developed for ETDRS at 4 meters or 3 meters if the electronic (E)-ETDRS system is employed.|3 months|||Letters||Standard Error|Mean
777068|NCT00770809|Secondary|Incidence of Adverse Events as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3|The type and grade of treatment-related toxicity will be tabulated by treatment arm.|Up to 30 days post-treatment||||||
777071|NCT00770809|Secondary|Overall Survival|Overall survival was measured as the interval from study entry until death, from any cause, or last contact. Distribution was estimated using the Kaplan Meier product-limit method|Time from randomization to death or last follow-up (up to 10 years)||||||
777074|NCT00770809|Primary|pCR Rate|Complete pathological response is defined as the absence of residual invasive carcinoma in the breast at the time of definitive surgical removal. Pathologic complete response in the lymph nodes is defined as no detectable invasive tumor by H&E. Analysis will use a chi-square test for the difference in proportions of patients on the THL arm versus the TH arm who achieve a pCR. Exact binomial methods will be used to construct 95% confidence intervals around the pCR incidence for each arm.|At time of surgery|Participants who did not start protocol therapy or withdrew prior to surgery are excluded. Participants who did not undergo surgery are considered no having a pCR.||percentage of participants||95% Confidence Interval|Number
777075|NCT00770861|Secondary|Change From Baseline in Trough Seated Systolic Blood Pressure (SBP) at Week 8 (LOCF).|The secondary efficacy parameter was the change from baseline in mean trough seated SBP at Week 8. The average of three consecutive BP measurements would be the mean trough seated SBP value.|From baseline visit 7 (week 0) to end of double-blind treatment phase visit 11 (week 8)|||mm Hg||Standard Deviation|Mean
777076|NCT00770861|Primary|Change From Baseline in Trough Seated DBP at Week 8(LOCF).|The primary efficacy parameter was the change from baseline in mean trough seated DBP at Week 8. The average of three consecutive BP measurements would be the mean trough seated DBP value.|From baseline visit 7 (week 0) to end of double-blind treatment phase visit 11 (week 8)|||mm Hg||Standard Deviation|Mean
777077|NCT00770913|Primary|Percentage of Participants With Healing Demonstrated Via Upper Gastrointestinal Endoscopy (Modified Los Angeles Classification: Grade N)|Grade N indicates a normal appearance of lower esophageal mucosa|8 weeks|The primary analysis was on the full analysis set (FAS) population.||Percentage of Participants|||Number
777078|NCT00770965|Secondary|Investigator Global Assessment (IGA) Scores|This study was not powered for efficacy. Due to audit findings at one site, which included 65 participants, all participants enrolled at the site were excluded from the planned efficacy analyses. As a result, efficacy could not be analyzed due to an insufficient number of participants.|baseline, day 1, weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32||||||
777079|NCT00770965|Secondary|Change From Baseline in PASI|This study was not powered for efficacy. Due to audit findings at one site, which included 65 participants, all participants enrolled at site were excluded from the planned efficacy analyses. As a result, efficacy could not be analyzed due to an insufficient number of participants.|baseline, weeks 12, 14, 16, 20, 24, 28 and 32||||||
777080|NCT00770965|Primary|Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores|This study was not powered for efficacy. Due to audit findings at one site, which included 65 participants, all participants enrolled at the site were excluded from the planned efficacy analyses. As a result, efficacy could not be analyzed due to an insufficient number of participants.|baseline, week 4||||||
777081|NCT00770991|Primary|Change in Burden of Rectal Polyps|The burden was measured as the sum of the number of polyps x size of polyps in mm. The change in burden was determined between baseline and 36 weeks.|Baseline and 36 weeks|||polyp number x mm||Standard Deviation|Mean
777082|NCT00770991|Secondary|Apoptosis and Cell Proliferation Measured by Percent Difference in Staining.|A pooled analysis of all participants was used for biomarker results. Tissue from normal mucosa and rectal polyps were obtained to assay KI 67 (proliferation) and TUNEL at baseline and end of treatment. A decrease in the value of KI 67 implies lower proliferation while an increase in TUNEL is suggestive of an increase in apoptosis.|baseline and 36 weeks|||percentage of brown staining of cells||Standard Deviation|Mean
777083|NCT00770991|Primary|Change From Baseline to End of Study in Number of Rectal Polyps||Baseline and 36 weeks|||polyps||Standard Deviation|Mean
777084|NCT00771056|Secondary|Time to Next Treatment|number of months to time from last HCQ dose to next CLL treatment|1 yr|only analyzed for participants that were treated within one year post last dose of hydroxychloroquine dose||months||Full Range|Mean
777085|NCT00771056|Primary|Percentage of Participants With Response|Percentage of participants with a reduction of the absolute lymphocytic count- ALC|1 yr|||percentage of participants|||Number
777086|NCT00771173|Primary|Reduction of Catheter-associated Discomfort During the Post-operative Period in the Gynecologic Patient Using Mean Visual Analogue Scale (VAS) Measurments|The VAS measures bladder pain on a straight line from 0 to 10 in centimeters, where a mark of zero indicates no pain and a mark of 10 indicates worst possible pain. Mean VAS score was recorded for participants in the active treatment and placebo cohorts.|24 hours|Per Protocol||centimeters||Standard Deviation|Mean
777087|NCT00771238|Secondary|Cost of Rental Beds|Cost was measured for Beds/Surfaces that are rented for Wound management / prevention purposes only|End of study|Tertiary Care ICU patients||US Dollars|||Number
777088|NCT00771238|Primary|Indicence of Pressure Ulcers|New pressure ulcers were assessed|at the end of study period (21 days)|Tertiary Care ICU patients||participants|||Number
777089|NCT00771264|Primary|"The Global Response Assessment (GRA) for Overall Bladder Symptoms to Compare the Proportion of Subjects Reporting Moderately or Markedly Improved Responses on the GRA After 12 Interventions of Randomized Therapy, in an Intent to Treat Analysis."|A responder was defined as reporting bladder symptoms as moderately or markedly improved on a 7-level GRA at week 13 after completing 12, 30-minute, consecutive weekly intervention sessions.|13 weeks|Intent to treat||participants|||Number
777090|NCT00771277|Secondary|Zarit Burden Inventory|Caregiver burden, as measured by the 12-item Zarit Burden Interview (Bédard et al., 2001; Zarit, Reever, & Bach-Peterson J, 1980). Burden includes concepts such as lack of time because of care, strain, restriction of life, etc. Items are scored from never (0) to nearly always (4), and higher total scores indicate greater burden. Total scores range from 0 to 88.|baseline|||units on a scale||Standard Deviation|Mean
777091|NCT00771277|Secondary|PHQ-9|The Patient Health Questionnaire (PHQ-9) (Kroenke, Spitzer, & Williams, 2001) assesses caregiver depression and anxiety on a scale from not at all (0) to nearly every day (3), with higher total scores indicating greater symptoms. Scores range from 0-27. PHQ-9 scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe, and severe depression respectively.|baseline|||units on a scale||Standard Deviation|Mean
777092|NCT00771277|Primary|Number of Participants Who Reported 5 Themes|Six caregivers of TBI patients were interviewed; responses were transcribed and coded; inter-rater agreement was calculated. Themes were lack of understanding about TBI and its long-term effects and the differences between TBI and PTSD, privacy concerns, independence, fear of negative employment/financial repercussions, and difficulty in interactions with the Department of Defense (DoD) and the Department of Veterans Affairs (VA)|collected over 3 interviews of approximately 1 hour each|||participants|||Number
777093|NCT00771316|Primary|Number of Participants With Serious Urinary Tract Infection With an Overall Microbiological Response to MK0826 Compared to Meropenem at Discontinuation of Intravenous Therapy (DCIV)|Microbiological response defined as: 1) Eradication-urine culture shows reduced uropathogen, 2)Persistence-urine culture taken after at least 2 days of therapy grows the original uropathogen, 3)Persistence with Acquisition of Resistance- urine culture taken after at least 2 days of therapy grows the original uropathogen but shows resistance to study drug, 4)Superinfection-Growth of uropathogen other than original pathogen, 5)New Infection-A new pathogen grows other than the original uropathogen, 6)Indeterminate-Any circumstance where impossible to define microbiological response.|After at least 4 days of IV therapy|This analysis was not completed due to early termination of the study.|||||
777094|NCT00771316|Primary|Number of Participants With Serious Urinary Tract Infection With a Clinical Response to MK0826 Compared to Meropenem at Discontinuation of Intravenous Therapy (DCIV)|Clinical response at DCIV defined as: 1) Improved-All or most pretherapy signs and symptoms of infection have improved and no additional antibiotic is required, 2) Failure-No response to therapy, persistence or progression of pretherapy signs and symptoms, 3) Indeterminate-Study data not available due to complications related to underlying medical condition, patient withdrawn from study or extenuating circumstances preclude classification as improved or failure.|After at least 4 days of IV therapy|This analysis was not completed due to early termination of the study.|||||
777095|NCT00771316|Primary|Number of Participants With Serious Urinary Tract Infection With an Overall Microbiological Response to MK0826 Compared to Meropenem at the 5 to 9 Day Post Therapy Early Follow-up Visit|Microbiological response defined as: 1) Eradication-urine culture shows reduced uropathogen, 2)Persistence-urine culture taken after at least 2 days of therapy grows the original uropathogen, 3)Persistence with Acquisition of Resistance- urine culture taken after at least 2 days of therapy grows the original uropathogen but shows resistance to study drug, 4)Superinfection-Growth of uropathogen other than original pathogen, 5)New Infection-A new pathogen grows other than the original uropathogen, 6)Indeterminate-Any circumstance where impossible to define microbiological response.|5 to 9 days post therapy|This analysis was not completed due to early termination of the study.|||||
777096|NCT00771407|Secondary|Stoma Quality of Life||Serially over 24 months||||||
777097|NCT00771407|Secondary|Stoma Complications||more than 1 month postoperatively||||||
777098|NCT00771407|Secondary|Stoma Complications||30 days||||||
777099|NCT00771407|Primary|Occurrence of Parastomal Hernia in Subjects Undergoing Permanent Abdominal Wall Ostomy Creation With and Without Strattice Fascial Inlay.||24 months|Efficacy Evaluable Population (received assigned treatment, completed all protocol-required evaluations, no major protocol violations).||participants|||Number
777100|NCT00771472|Secondary|Part I: The Amount of Time it Takes for the Drug Concentration to Decrease by Half (T1/2)|"Blood samples taken as follows:
Day 1 & Day 28 of Cycle 1: pre dose, and 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12 and 24 hours after dosing of vorinostat."|Days 1 & 28 of Cycle 1|Number of participants with samples at the specified time point||hours||Standard Deviation|Geometric Mean
777101|NCT00771472|Secondary|Part I: Time at Which Cmax Occurs (Tmax)|"Blood samples taken as follows:
Day 1 & Day 28 of Cycle 1: pre dose, and 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12 and 24 hours after dosing of vorinostat."|Days 1 & 28 of Cycle 1|Number of participants with samples at the specified time point||hours||Full Range|Median
777102|NCT00771472|Secondary|Part I: Maximum Drug Concentration (Cmax)|"Blood samples taken as follows:
Day 1 & Day 28 of Cycle 1: pre dose, and 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12 and 24 hours after dosing of vorinostat."|Days 1 & 28 of Cycle 1|Number of participants with samples at the specified time point||µM||Standard Deviation|Geometric Mean
777103|NCT00771472|Primary|Part I: Number of Participants Experiencing Dose Limiting Toxicity (DLT)|"A DLT was defined as any of the following (per Common Terminology Criteria for Adverse Events [CTCAE] version 3.0):
Grade 3 (severe)-4 (life-threatening) neutropenia with fever ≥ 38.5ºC
Grade 3-4 neutropenia with an infection requiring antibiotic or antifungal treatment
Grade 4 neutropenia lasting at least 5 days
Grade 4 thrombocytopenia
Other Grade 4 hematologic toxicity, including a decrease in hemoglobin, only at the discretion of the principal investigator
Grade 3 or 4 non-hematologic event, except which are manageable by supportive care or non-prohibited therapies"|Day 1 to Day 28|||participants|||Number
777104|NCT00771472|Secondary|Part I: Total Drug Exposure (Area Under the Concentration Curve, AUC[0-24 Hours])|"Blood samples taken as follows:
Day 1 & Day 28 of Cycle 1: pre dose, and 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12 and 24 hours after dosing of vorinostat."|Days 1 & 28 of Cycle 1|Number of participants with samples at the specified time point||µM*hr||Standard Deviation|Geometric Mean
777105|NCT00771472|Primary|Parts I & II: Number of Participants Experiencing Clinical or Laboratory Adverse Experiences (AE)|A laboratory AE is defined as any unfavorable & unintended change in the chemistry of the body temporally associated with the use of study product, whether or not considered related to the use of the product. A clinical AE is defined similarly but also includes changes in structure or function of the body.|Day 1 up until 30 days post study completion or early termination (up to approximately 506 days)|||participants|||Number
777106|NCT00771537|Primary|Willingness to Participate in a HIV Vaccine Clinical Trial|Willingness to Participate in a HIV Vaccine Clinical Trial. Assessed via participant self-report with 6 items on Part 2 of the questionnaire. Item responses measured on 5-point Likert-type scale ranging from Strongly Disagree (value = 1) to Strongly Agree (value = 5).|Approximately 60 minutes into the study visit, at the end of Part 2 of the questionnaire.|Only participants who answered the Willingness to Participate questions on the survey were included in these analyses.||units on a scale||Standard Deviation|Mean
777107|NCT00771537|Primary|Number of Participants Who Accepted Rapid HIV Testing.|Acceptance of rapid HIV testing. Acceptance was assessed by actual administration of rapid oral HIV test by research staff.|During study visit. At approximately 30 minutes into the study visit. After part 1 of the questionnaire was completed.|||participants|||Number
777108|NCT00771602|Secondary|52 Week Toxicity Rate|The definition of toxicities include any >/= grade 3 non-hematologic toxicity, >/= grade 3 infection, and any symptomatic (i.e. febrile) documented CMV (cytomegalovirus) reactivation, according to NCI-WG definitions.|52 weeks||||||
777109|NCT00771602|Secondary|Progression-free Survival|Progression-free survival (PFS) is measured from date of trial entry until documented progression of disease or death from any cause.|52 weeks or until disease progression||||||
777110|NCT00771602|Primary|Number of Patients With Molecular Remissions at 52 Weeks|Molecular Remissions (minimal residual disease (MRD) flow cytometry-negative) after monoclonal antibody consolidation therapy. Molecular remission is defined as resolution of all detectable disease below the limits of the MRD flow cytometry assay sensitivity.|52 weeks|No analysis available participant ineligible for evaluation; study terminated due to slow accrual.|||||
777111|NCT00771615|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs).|A SAE was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination.|From Day 0 to Day 378|The analysis was performed on the Total Vaccinated cohort, which included all subjects who received study vaccine and for whom any post-vaccination data were available.||Subjects|||Number
777112|NCT00771615|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).|An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.“Any” was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|From Day 0 to Day 42|The analysis was performed on the Total Vaccinated cohort, which included all subjects who received study vaccine and for whom any post-vaccination data were available.||Subjects|||Number
777113|NCT00771615|Secondary|Number of Subjects With Medically-attended Adverse Events (MAEs).|MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s).|From Day 0 to Day 378|The analysis was performed on the Total Vaccinated cohort, which included all subjects who received study vaccine and for whom any post-vaccination data were available.||Subjects|||Number
777114|NCT00771615|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms.|Solicited general symptoms assessed were fatigue, headache, joint pain at other location (joint pain), muscle aches, shivering, sweating and fever. Any =occurrence of any solicited general symptoms reported irrespective of intensity grade and relationship to vaccination. Any fever = oral temperature ≥ 38.0 degrees Celsius (°C).|Within the 7-day (Days 0-6) post vaccination period.|The analysis was performed on the Total Vaccinated cohort, which included all subjects who received study vaccine and for whom any post-vaccination data were available.||Subjects|||Number
777115|NCT00771615|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any solicited local symptoms regardless of their intensity grade.|Within the 7-day (Days 0-6) post vaccination period.|The analysis was performed on the Total Vaccinated cohort, which included all subjects who received study vaccine and for whom any post-vaccination data were available.||Subjects|||Number
777116|NCT00771615|Secondary|Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains.|VRR was defined as a 4-fold rise from a detectable baseline titer or a rise from undetectable (< 1:28, recorded 1:14 if < 1:28) to ≥ 1:56 in the subjects.|At Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.||Subjects|||Number
777117|NCT00771615|Secondary|Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains|VRR was defined as a 4-fold rise from a detectable baseline titer or a rise from undetectable (< 1:28, recorded 1:14 if < 1:28) to ≥ 1:56 in the subjects.|At Day 42|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.||Subjects|||Number
777118|NCT00771615|Secondary|Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains.|VRR was defined as a 4-fold rise from a detectable baseline titer or a rise from undetectable (< 1:28, recorded 1:14 if < 1:28) to ≥ 1:56 in the subjects.|At Day 10|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.||Subjects|||Number
777119|NCT00771615|Secondary|Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains.|A seropositive subject was defined as a vaccinated subject who had a MN antibody titer ≥ the cut-off value of 1:28.|At Day 0, Day 10, Day 42 and Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.||Subjects|||Number
777120|NCT00771615|Secondary|Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains.|MN antibody titers were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of ≥ 1:28.|At Day 0, Day 10, Day 42 and Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.||Titer||95% Confidence Interval|Geometric Mean
777121|NCT00771615|Secondary|HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Indonesia/5/2005 (A/Indo) Virus Strains.|GMFR were defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer.|At Day 10, Day 42 and Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.||fold increase||95% Confidence Interval|Geometric Mean
777122|NCT00771615|Secondary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) Virus Strains.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.|At Day 0 to Day 10, Day 42 and Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.||Subjects|||Number
777123|NCT00771615|Secondary|Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains.|A seroprotected subject was defined as a subject with serum HI antibody reciprocal titer ≥ 1:40 post-vaccination, a level of HI antibodies that may correlate with benefit in protection against influenza.|At Day 0, Day 10, Day 42 and Day 182 for A/Indo and at Day 0, Day 42 and Day 182 for A/turkey virus strains.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.||Subjects|||Number
777124|NCT00771615|Secondary|HI Antibody Titers Against the A/Indonesia/5/2005 (A/Indo) Virus Strain.|Titers were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of ≥ 1:10|At Day 0, Day 10, Day 42 and Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.||Titer||95% Confidence Interval|Geometric Mean
777125|NCT00771615|Secondary|HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.|GMFR were defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer.|At Day 0 to Day 10, Day 42 and Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.||fold increase||95% Confidence Interval|Geometric Mean
777126|NCT00771615|Secondary|Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 Virus Strain.|Titers were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of ≥ 1:10|At Day 0, Day 10, Day 42 and Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.||Titer||95% Confidence Interval|Geometric Mean
777127|NCT00771615|Secondary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) titer less than (<) 1:10 for HI and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40, or a pre-vaccination reciprocal titer ≥ 1:10 for HI and at least a 4-fold increase in post-vaccination reciprocal titer.|At Day 0 to Day 42 and at Day 0 to Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.||Subjects|||Number
777128|NCT00771615|Primary|Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.|HI antibody titers were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of ≥ 1:10.|At Day 10|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.||Titer||95% Confidence Interval|Geometric Mean
777129|NCT00771615|Primary|Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain|A seroprotected subject against the A/turkey virus strain was defined as a subject with serum HI antibody reciprocal titer ≥ 1:40 post-vaccination, a level of HI antibodies that may correlate with benefit in protection against influenza.|At Day 10|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.||Subjects|||Number
777130|NCT00771615|Primary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) titer less than (<) 1:10 for HI and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40, or a pre-vaccination reciprocal titer ≥ 1:10 for HI and at least a 4-fold increase in post-vaccination reciprocal titer.|At Day 10|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.||Subjects|||Number
777138|NCT00771745|Secondary|Malignancy||Undefined||||||
777139|NCT00771745|Secondary|Serum Creatinine||Post-operative days 1-7, 30, 90 and 6 months||||||
777140|NCT00771745|Secondary|Severity of Biopsy-proven Rejection Using Banff 97 Criteria||Not defined||||||
777141|NCT00771745|Secondary|Need for Antilymphocyte Antibody Therapy to Treat Acute Rejection||Not defined||||||
777142|NCT00771745|Secondary|Incidence of Infections||Not defined||||||
777143|NCT00771745|Secondary|Incidence of Treatment Failures: Defined as the Percentage of Patients That do Not Remain on Initial Therapy.||Ongoing||||||
777144|NCT00771745|Primary|Composite End Point of Acute Rejection, Graft Loss or Patient Death|Proportion of Patients Meeting the Composite End Point of Acute Rejection, Graft loss or Patient death|6 months|Patients received tacrolimus (goal level 10-15 ng/mL) and mycophenolate mofetil (2gm daily) at time of transplant. Methylprednisolone (MP), acetaminophen, and diphenhydramine were given as premedication for each rATG dose (500mg MP 1st dose, 250mg MP subsequent 2 doses, 125mg MP 4th dose).||participants|||Number
777145|NCT00771758|Secondary|Summary of Clinician Ease-of-Care at the End of Study: Bothersome|"The Clinician Ease-of-Care was defined on a 6-point scale, where 0 = not at all to 5=a very great deal."|Day 10|Intent-to Treat population.||percent of participants|||Number
777146|NCT00771758|Secondary|Summary of Clinician Ease-of-Care at the End of Study: Time Comsuming|The Clinician Ease-of-Care was defined on a 6-point scale, where 0 = “not at all” to 5=“a very great deal.”|Day 10|Intent-to Treat population.||percent of participants|||Number
777147|NCT00771758|Secondary|Clinician Global Impression of Change (CGIC) at End of Study|Clinician Global Impression of Change (CGIC) was defined as the 7-point numeric scale, where 1=very much improved to 7=very much worse.|Day 10|Intent-to-Treat population.||percenatage of participants|||Number
777148|NCT00771758|Secondary|Patient Global Impression of Change (PGIC) at End of Study|Patient Global Impression of Change (PGIC) was defined as the 7-point numeric scale, where 1=very much improved to 7=very much worse.|Day 10|Intent-to-Treat population.||percenatage of participants|||Number
777149|NCT00771758|Secondary|Summary of Functionality: Chair - Proportion With at Least 2 Points of Improvement From Baseline to Day 10|Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.|Day 10|Intent-to-Treat population.||percentage of participants|||Number
777150|NCT00771758|Secondary|Summary of Functionality: Chair - Proportion With at Least 2 Points of Improvement From Baseline to Day 5|Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.|Day 5|Intent-to-Treat population.||percentage of participants|||Number
777151|NCT00771758|Secondary|Summary of Functionality: Chair - Proportion With at Least 2 Point of Improvement From Baseline to Day 3|Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.|Day 3|Intent-to-Treat population.||percentage of participants|||Number
777152|NCT00771758|Secondary|Summary of Functionality: Chair - Proportion With at Least 2 Points of Improvement From Baseline to Day 2|Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.|Day 2|Intent-to-Treat population.||percentage of participants|||Number
777153|NCT00771758|Secondary|Summary of Functionality: Bath/Shower - Proportion With at Least 2 Points of Improvement From Baseline to Day 10|Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.|Day 10|Intent-to-Treat population.||percentage of participants|||Number
777154|NCT00771758|Secondary|Summary of Functionality: Bath/Shower - Proportion With at Least 2 Points of Improvement From Baseline to Day 5|Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.|Day 5|Intent-to-Treat population.||percentage of participants|||Number
777155|NCT00771758|Secondary|Summary of Functionality: Bath/Shower - Proportion With at Least 2 Points of Improvement From Baseline to Day 3|Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.|Day 3|Intent-to-Treat population.||percentage of participants|||Number
777156|NCT00771758|Secondary|Summary of Functionality: Bath/Shower - Proportion With at Least 2 Points of Improvement From Baseline to Day 2|Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.|Day 2|Intent-to-Treat population.||percentage of participants|||Number
777157|NCT00771758|Secondary|Summary of Functionality: Dressing - Proportion With at Least 2 Points of Improvement From Baseline to Day 10|Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.|Day 10|Intent-to-Treat population.||percentage of participants|||Number
777158|NCT00771758|Secondary|Summary of Functionality: Dressing - Proportion With at Least 2 Points of Improvement From Baseline to Day 5|Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.|Day 5|Intent-to-Treat population.||percentage of participants|||Number
777159|NCT00771758|Secondary|Summary of Functionality: Dressing - Proportion With at Least 2 Points of Improvement From Baseline to Day 3|Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.|Day 3|Intent-to-Treat population.||percentage of participants|||Number
777160|NCT00771758|Secondary|Summary of Functionality: Dressing - Proportion With at Least 2 Points of Improvement From Baseline to Day 2|Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.|Day 2|Intent-to-Treat population.||percentage of participants|||Number
777161|NCT00771758|Secondary|Sleep Quality - Shift From Baseline to End of Study (Placebo)|"Sleep Quality was assessed by a 4-point numeric scale (1=excellent, 2=good, 3=fair, and 4=poor). The sleep question was Please rate the overall quality of your sleep last night., which was administered via IVR system in the morning."|10 days|Placebo arm of Intent-to-Treat population. Shift table from baseline to end of study. Percentages were based on the number of intent-to-treat subjects within a screening category.||participants|||Number
777162|NCT00771758|Secondary|Sleep Quality - Shift From Baseline to End of Study (Oxycodone IR)|"Sleep Quality was assessed by a 4-point numeric scale (1=excellent, 2=good, 3=fair, and 4=poor). The sleep question was Please rate the overall quality of your sleep last night., which was administered via IVR system in the morning."|10 days|Oxycodone IR arm of Intent-to-Treat population. Shift table from baseline to end of study. Percentages were based on the number of intent-to-treat subjects within a screening category.||participants|||Number
777163|NCT00771758|Secondary|Sleep Quality - Shift From Baseline to End of Study (Tapentadol IR)|"Sleep Quality was assessed by a 4-point numeric scale (1=excellent, 2=good, 3=fair, and 4=poor). The sleep question was Please rate the overall quality of your sleep last night., which was administered via Interactive Voice Response (IVR) system in the morning."|10 days|Tapentadol IR arm of Intent-to-Treat population. Shift table from baseline to end of study. Percentages were based on the number of intent-to-treat subjects within a screening category.||participants|||Number
777164|NCT00771758|Secondary|Summary of Subject Satisfaction With Treatment on Day 10|Treatment satisfaction was measured using a 7-point scale where 1 = very satisfied and 7 = very dissatisfied.|Day 10|Intent-to-Treat population.||Scores on a scale||Standard Deviation|Mean
777165|NCT00771758|Secondary|Summary of Subject Satisfaction With Treatment on Day 5|Treatment satisfaction was measured using a 7-point scale where 1 = very satisfied and 7 = very dissatisfied.|Day 5|Intent-to-Treat population.||Scores on a scale||Standard Deviation|Mean
777166|NCT00771758|Secondary|Summary of Subject Satisfaction With Treatment on Day 3|Treatment satisfaction was measured using a 7-point scale where 1 = very satisfied and 7 = very dissatisfied.|Day 3|Intent-to-Treat population.||Scores on a scale||Standard Deviation|Mean
777167|NCT00771758|Secondary|Summary of Subject Satisfaction With Treatment on Day 2|Treatment satisfaction was measured using a 7-point scale where 1 = very satisfied and 7 = very dissatisfied.|Day 2|Intent-to-Treat population.||Scores on a scale||Standard Deviation|Mean
777168|NCT00771758|Secondary|Change From Baseline in Physical Performance: Chair Stand - Change in Time Taken to Complete Chair Stands in the End of Study|"The time for the subject to rise from a chair 5 times was measured at baseline and the end of study.
Change = baseline - end of study. For the change in each treatment group, only subjects who were assessed at both baseline and end of study were summarized. A positive value of Change indicated performance improved."|Day 10|Intent-to-Treat subjects.||second||Standard Deviation|Mean
777169|NCT00771758|Secondary|Change From Baseline in Physical Performance: Chair Stand - Change in Number of Chair Stands Completed in the End of Study|The participants were assessed whether were able to rise from a chair 5 times at each visit. For those subjects who were unable to complete all 5 rises, the number of rises would be recorded. For those completed the 5 rises, 5 were recorded. The change in number of chair stands at the end of study was derived using the number of chair stands at baseline minus the number of chair stands at the end of study (Day 10). The range of change in number of chair stands is from -5 to 5. A negative value indicated better performance.|Day 10|Intent-to-Treat subjects.||chair stands||Standard Deviation|Mean
777170|NCT00771758|Secondary|Change From Baseline in Physical Performance: Measured Walk - Change in Time Taken Per Meter to Take Walk in the End of Study|The time for the subject to walk for 4 meters was measured at baseline and the end of study. Change = baseline - end of study. For the change in each treatment group, only subjects who were assessed at both baseline and end of study were summarized. A positive value of Change indicated performance improved.|Day 10|Intent-to-Treat subjects.||seconds||Standard Deviation|Mean
777171|NCT00771758|Secondary|Change From Baseline in Physical Performance: Measured Walk - Change in Distance Walked in the End of Study|The participants were assessed whether were able to walk for 4 meters at each visit. For those subjects who were unable to walk 4 meters, the distance walked would be recorded. For those completed the walk, 4 meters were recorded. The change in distance walked at the end of study was derived using the distance walked at baseline minus the distance walked at the end of study (Day 10). The range of change in distance walked is from -4 to 4. A negative value indicated better performance.|Day 10|Intent-to-Treat subjects.||meters||Standard Deviation|Mean
777172|NCT00771758|Secondary|Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) Over 10 Days|The Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) was derived from Sum of TOTPAR and SPID. The range of SPRID over 10 days is from -2160 to 3024. A higher value in SPRID indicated greater pain relief.|10 Days|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.||Scores on a scale||Standard Deviation|Mean
777173|NCT00771758|Secondary|Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) Over 5 Days|The Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) was derived from Sum of TOTPAR and SPID. The range of SPRID over 5 days is from -1200 to 1680. A higher value in SPRID indicated greater pain relief.|5 Days|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.||Scores on a scale||Standard Deviation|Mean
777174|NCT00771758|Secondary|Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) Over 3 Days|The Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) was derived from Sum of TOTPAR and SPID. The range of SPRID over 3 days is from -720 to 1008. A higher value in SPRID indicated greater pain relief.|3 Days|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.||Scores on a scale||Standard Deviation|Mean
777186|NCT00771758|Secondary|30% Responder Rate on Day 5.|The 30% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 30% from baseline in pain intensity at Day 5 (average of Day 5 PM and Day 6 AM).|Day 5|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.||percentage of participants|||Number
777175|NCT00771758|Secondary|Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) Over 2 Days|The Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) was derived from Sum of TOTPAR and SPID. The range of SPRID over 2 days is from -480 to 672. A higher value in SPRID indicated greater pain relief.|2 Days|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.||Scores on a scale||Standard Deviation|Mean
777176|NCT00771758|Secondary|Total Pain Relief (TOTPAR) Over 10 Days|Pain Relief was defined as a 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum over all pain relief up to Day 10, 8 AM. The range of TOTPAR over 10 days is from 0 to 864. A higher value in TOTPAR indicated greater pain relief.|10 Days (216 Hours)|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.||Scores on a scale||Standard Deviation|Mean
777177|NCT00771758|Secondary|Total Pain Relief (TOTPAR) Over 5 Days|Pain Relief was defined as a 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum over all pain relief up to hour 120. The range of TOTPAR over 5 days is from 0 to 480. A higher value in TOTPAR indicated greater pain relief.|5 Days (120 Hours)|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.||Scores on a scale||Standard Deviation|Mean
777178|NCT00771758|Secondary|Total Pain Relief (TOTPAR) Over 3 Days|Pain Relief was defined as a 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum over all pain relief up to hour 72. The range of TOTPAR over 3 days is from 0 to 288. A higher value in TOTPAR indicated greater pain relief.|3 Days (72 Hours)|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.||Scores on a scale||Standard Deviation|Mean
777179|NCT00771758|Secondary|Total Pain Relief (TOTPAR) Over 2 Days|Pain Relief was defined as a 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum over all pain relief up to hour 48. The range of TOTPAR over 2 days is from 0 to 192. A higher value in TOTPAR indicated greater pain relief.|2 Days (48 Hours)|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.||Scores on a scale||Standard Deviation|Mean
777180|NCT00771758|Secondary|Sum of Pain Intensity Difference Over 10 Days|Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. Sum of Pain Intensity Difference Over 10 Days was calculated as the time-weighted Sum of PID scores up to Day 10, 8 AM. The range is from -2160 to 2160. The higher value in Sum of Pain Intensity Difference indicates greater pain relief.|10 Days (216 Hours)|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.||Scores on a scale||Standard Deviation|Mean
777181|NCT00771758|Secondary|Sum of Pain Intensity Difference Over 5 Days (SPID120)|Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID120 was calculated as the time-weighted Sum of PID scores over 120 hours. The range of SPID120 is from -1200 to 1200. The higher value in SPID indicates greater pain relief.|5 Days (120 hours)|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.||Scores on a scale||Standard Deviation|Mean
777182|NCT00771758|Secondary|Sum of Pain Intensity Difference Over 2 Days (SPID48)|Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID48 was calculated as the time-weighted Sum of PID scores over 48 hours. The range of SPID48 is from -480 to 480. The higher value in SPID indicates greater pain relief.|2 Days (48 hours)|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.||Scores on a scale||Standard Deviation|Mean
777183|NCT00771758|Secondary|50% Responder Rate on Day 10.|The 50% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 50% from baseline in pain intensity at Day 10 (average of Day 9 PM and Day 10 AM).|Day 10|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.||percentage of participants|||Number
777184|NCT00771758|Secondary|30% Responder Rate on Day 10.|The 30% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 30% from baseline in pain intensity at Day 10 (average of Day 9 PM and Day 10 AM).|Day 10|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.||percentage of participants|||Number
777185|NCT00771758|Secondary|50% Responder Rate on Day 5.|The 50% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 50% from baseline in pain intensity at Day 5 (average of Day 5 PM and Day 6 AM).|Day 5|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.||percentage of participants|||Number
777236|NCT00763867|Other Pre-specified|Best Available Creatinine|Best available=local lab results only when core lab results not available|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mg/dL||Standard Deviation|Mean
777187|NCT00771758|Secondary|50% Responder Rate on Day 3.|The 50% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 50% from baseline in pain intensity at Day 3 (average of Day 3 PM and Day 4 AM).|Day 3|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.||percentage of participants|||Number
777188|NCT00771758|Secondary|30% Responder Rate on Day 3.|The 30% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 30% from baseline in pain intensity at Day 3 (average of Day 3 PM and Day 4 AM).|Day 3|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the Interactive Voice Response (IVR) system with score ≥5 on an 11-point NRS.||percentage of participants|||Number
777189|NCT00771758|Primary|Sum of Pain Intensity Difference Over 3 Days (SPID72)|"Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID72 was calculated as the time-weighted Sum of PID scores over 72 hours. The range of SPID72 is from -720 to 720. The higher value in SPID indicates greater pain relief.
The study was terminated prematurely due to slow enrollment after 108 of 600 subjects enrolled. Valid statistical conclusions cannot be made due to the low number of subjects."|3 Days (72 hours)|The modified Intent-to-Treat(mITT) population was defined as all randomized patients who took at least one dose of study drug and had a baseline pain intensity assessment via the Interactive Voice Response (IVR) system with score ≥5 on an 11-point NRS.||Scores on a scale||Standard Deviation|Mean
777190|NCT00771810|Secondary|Rescue Treatment for Hematopoiesis and Mucositis|"Number of subjects with a treatment emergent adverse event of hematopoiesis and mucositis who received rescue treatment as determined by the administration of:
Transfusions
Filgrastim or Pegfilgrastim
Erythropoietin
Palifermin"|During a maximum of six 3-week chemotherapy cycles|The number of participants for analysis was the safety population.||Participants|||Number
777191|NCT00771810|Secondary|Alopecia|Number of subjects with a treatment emergent adverse event of alopecia|During a maximum of six 3-week chemotherapy cycles|The number of participants for analysis was the safety population.||Participants|||Number
777192|NCT00771810|Secondary|Mucositis|Number of subjects with a treatment emergent adverse event of mucositis|During a maximum of six 3-week chemotherapy cycles|The number of participants for analysis was the safety population.||Participants|||Number
777193|NCT00771810|Secondary|Anemia|Number of subjects with a treatment emergent adverse event of anemia|During a maximum of six 3-week chemotherapy cycles|The number of participants for analysis was the safety population.||Participants|||Number
777194|NCT00771810|Secondary|Neutropenia|Number of subjects with a treatment emergent adverse event of neutropenia|During a maximum of six 3-week chemotherapy cycles|The number of participants for analysis was the safety population.||Participants|||Number
777195|NCT00771810|Secondary|Lymphopenia as Determined by Lymphocyte Count|Number of subjects with a treatment emergent adverse event of lymphopenia|During a maximum of six 3-week chemotherapy cycles|The number of participants for analysis was the safety population.||Participants|||Number
777196|NCT00771810|Secondary|Chemotherapy Dose Intensity and Dose Density|Mean percentage of cycles where projected (target) chemotherapy dose was maintained|During a maximum of six 3-week chemotherapy cycles|The number of participants for analysis was the intention to treat population.||Percentage of cycles||Full Range|Mean
777197|NCT00771810|Secondary|Treatment Cycles With Platelets Counts Below 25,000/mm3|Mean percentage of treatment cycles where platelets counts were below 25,000/mm3|During a maximum of six 3-week chemotherapy cycles|The number of participants for analysis was the intention to treat population.||Percentage of cycles||Full Range|Mean
777198|NCT00771810|Secondary|Subjects With Platelet Counts Below 50,000/mm3|Number of subjects who experienced a platelet count below 50,000/mm3|During a maximum of six 3-week chemotherapy cycles|The number of participants for analysis was the safety population.||Participants|||Number
777199|NCT00771810|Primary|Chemotherapy Cycles During Which the Platelet Count Measures Below 50,000/mm3|Mean percentage of cycles with platelet counts below 50,000/mm3|During a maximum of six 3-week chemotherapy cycles|The number of participants for analysis was the intention to treat population.||Percentage of cycles||Full Range|Mean
777200|NCT00771849|Secondary|Participants With a ≥ 4-Fold Rise in Antibody Titers as Measured by Serum Bactericidal Assay (SBA) From Baseline to Day 28 Post-vaccination.||28 days post-vaccination|SBA titers for each of the 4 meningococcal serogroups was evaluated in the per-protocol population.||Participants|||Number
777201|NCT00771849|Primary|Geometric Mean of Antibody Titers (GMTs) as Measured by Serum Bactericidal Assay (SBA) at Baseline (Day 0) and Day 28 Post-vaccination.||Day 0 (before) and 28 days post-vaccination|SBA geometric mean titers for each of the 4 meningococcal serogroups was evaluated in the per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
777202|NCT00771875|Secondary|Incidence of Post Transplant Lymphoproliferative Disorder (PTLD)||1 year|||participants|||Number
777203|NCT00771875|Secondary|Number of Patients With Allografts With C4d Diffuse Positive Pretreatment Biopsy||90 days|||participants|||Number
777204|NCT00771875|Secondary|Incidence of Death||90 days|||participants|||Number
777205|NCT00771875|Secondary|Mean Serum Creatinine|Renal allograft function as determined by change (∆) in Calculated creatinine clearance by Cockcroft-Gault at 7, 14, 28, 60, and 90 days and 1 year post therapy initiation|7, 14, 28, 60, 90 days and 1 year post therapy initiation|||mg/dL||Standard Deviation|Mean
777206|NCT00771875|Secondary|Renal Allograft Survival||1 year after rejection treatment|||participants|||Number
777207|NCT00771875|Secondary|Number of Patients With Allografts With C4d Focal Positive Pretreatment Biopsy||Day 1|||participants|||Number
777208|NCT00771875|Primary|Number of Patients in Each Group With Any of the Following: Rejection Reversal or Recurrent Rejection|"Rejection Reversal is a return of serum creatinine to within 115% of the baseline value, or histologic reversal occurring within 14 days of initiation of treatment.
Recurrent Rejection is histologic evidence of rejection noted on a biopsy specimen obtained up to 3 months after documented rejection reversal."|1 year|||participants|||Number
789796|NCT00867568|Secondary|Cmax of TPI 287in Pediatrics Using Pharmacokinetic (PK) Testing.||Cycle 3 day 1 at Pre dose, 0 (end of infusion), 0.25, 0.5, 1, 2, 4, and 6 hours post dose|Six patients at the MTD dose of 125mg/m2/dose||ng/ml||Standard Error|Mean
777209|NCT00771914|Primary|the Difference Between the Time to Clot Formation in Seconds at Baseline and After Each Treatment|The PFA-100 test measures platelet function as the time that it takes for a clot to form in a collagen-lined cartridge.|4 hours|Each participant acted as own control since each received the intervention (placebo, aspirin, lovaza, and both aspirin and lovaza) and had these effects compared to baseline (four hour effect of each intervention).||seconds||Standard Deviation|Mean
777210|NCT00771927|Secondary|The Incidence of Predefined Psychiatric Treatment-Emergent Adverse Events (TEAEs) in Epilepsy Patients With Partial-onset Seizures While on Vimpat or Any Other add-on Antiepileptic Drug (AED) Treatment During the Study|"Predefined psychiatric-related AEs, ie, depression, suicide/self-injury, drug abuse, drug dependence, substance abuse, and intentional drug misuse were predefined as AEs coded to one of the following MedDRA Preferred Terms: Depression, Major depression, Depressed mood, Depression suicidal, Completed suicide, Suicidal behavior, Suicidal ideation, Suicide attempt, Intentional self-injury, Self-injurious behavior, Self-injurious ideation, Poisoning deliberate, Drug abuse, Drug abuser, Drug dependence, Substance abuse, Substance abuser, Polysubstance dependence, Intentional drug misuse, Intentional overdose, or Multiple drug overdose intentional.
Treatment-emergent Adverse Events (TEAEs) are those that start on or after the day of first intake of the add-on AED treatment and up to 30 days after the day of last add-on AED treatment intake."|From Baseline up to 12 months|Safety Set (SS) population||Treatment-Emergent Adverse Events|||Number
777211|NCT00771927|Primary|The Incidence of Predefined Cardiovascular Treatment-Emergent Adverse Events (TEAEs) in Epilepsy Patients With Partial-onset Seizures While on Vimpat or Any Other add-on Antiepileptic Drug (AED) Treatment During the Study|"Predefined cardiovascular-related Adverse Events (AEs), ie, Atrioventricular (AV) block, syncope, bradycardia, and PR prolongation, were identified as AEs coded to one of the following MedDRA Preferred Terms: Adams-Stokes syndrome, Atrioventricular block, Atrioventricular block complete, Atrioventricular block first degree, Atrioventricular block second degree, Syncope, Bradycardia, Bradyarrhythmia, Sinus bradycardia, or Electrocardiogram PR prolongation.
Treatment-emergent Adverse Events (TEAEs) are those that start on or after the day of first intake of the add-on AED treatment and up to 30 days after the day of last add-on AED treatment intake."|From Baseline up to 12 months|Safety Set (SS) population||Treatment-Emergent Adverse Events|||Number
777212|NCT00771953|Primary|Progression Free Survival|For determining progression-free survival, progression was determined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Progression was defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|From the date of randomization until the first date that recurrent or progressive disease is objectively documented.|||days||95% Confidence Interval|Median
777213|NCT00763815|Other Pre-specified|Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia|Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the patient required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.|First dose of study drug up to 3 days after the last dose administration, for up to 132 weeks|Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.||participants|||Number
777214|NCT00763815|Other Pre-specified|Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.||percentage of participants|||Number
777215|NCT00763815|Secondary|Percentage of Patients Requiring Rescue Therapy During Main 24-Week Period|Routine fasting self-monitored plasma glucose (SMPG) and central laboratory FPG (and HbA1c after week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after week 12) were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG >270 milligram/deciliter (mg/dL) (15.0 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 24: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >8.5%. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline up to Week 24|mITT population.||percentage of participants|||Number
777216|NCT00763815|Secondary|Change From Baseline in Beta-cell Function Assessed by Homeostasis Model Assessment for Beta-cell Function (HOMA-beta) at Week 24|Beta cell function was assessed by HOMA-beta. HOMA-beta (% of normal beta cells function) = (20 multiplied by fasting plasma insulin [micro unit per milliliter]) divided by (fasting plasma glucose [mmol/L] minus 3.5). Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HOMA-beta assessment during on-treatment period.||% of normal beta cells function||Standard Error|Least Squares Mean
777217|NCT00763815|Secondary|Percentage of Patients With HbA1c Level Less Than or Equal to 6.5% at Week 24|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.||percentage of participants|||Number
777218|NCT00763815|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.||percentage of participants|||Number
777219|NCT00763815|Secondary|Change From Baseline in Fasting Plasma Insulin (FPI) at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline FPI assessment during on-treatment period.||pmol/L||Standard Error|Least Squares Mean
777220|NCT00763815|Secondary|Change From Baseline in Body Weight at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.||kilogram||Standard Error|Least Squares Mean
777221|NCT00763815|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using last observation carried forward (LOCF). Here, number of patients analyzed = patients with baseline and at least 1 post-baseline FPG assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
777222|NCT00763815|Primary|Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|Absolute change = HbA1c value at Week 24 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population:all randomized patients who received at least 1 dose;had baseline,at least 1 post-baseline efficacy assessment, irrespective of compliance with study protocol/procedures. Last observation carried forward used. Number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.||percentage of hemoglobin||Standard Error|Least Squares Mean
777223|NCT00763867|Other Pre-specified|Furosemide-Equivalent Dose||Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mg||Standard Deviation|Mean
777224|NCT00763867|Other Pre-specified|Galectin 3||Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||ng/mL||Standard Deviation|Mean
777225|NCT00763867|Other Pre-specified|Cyclic Guanosine Monophosphate (cGMP)||Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||pmol/mL||Standard Deviation|Mean
777226|NCT00763867|Other Pre-specified|Collagen Type I (CITP)||Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||ug/L||Standard Deviation|Mean
777227|NCT00763867|Other Pre-specified|High Sensitivity C-Reactive Protein||Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mg/L||Standard Deviation|Mean
777228|NCT00763867|Other Pre-specified|Endothelin-1||Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||pg/mL||Standard Deviation|Mean
777229|NCT00763867|Other Pre-specified|Procollagen III N-terminal Peptide||Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||ug/L||Standard Deviation|Mean
777230|NCT00763867|Other Pre-specified|High Sensitivity Troponin I||Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||pg/mL||Standard Deviation|Mean
777231|NCT00763867|Other Pre-specified|Aldosterone||Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||pg/mL||Standard Deviation|Mean
777232|NCT00763867|Other Pre-specified|N-terminal Pro B-type Natriuretic Peptide (NT Pro-BNP)||Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||pg/mL||Standard Deviation|Mean
777233|NCT00763867|Other Pre-specified|Uric Acid||Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mg/dL||Standard Deviation|Mean
777234|NCT00763867|Other Pre-specified|Cystatin C||Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mg/L||Standard Deviation|Mean
777235|NCT00763867|Other Pre-specified|Best Available Glomerular Filtration Rate (GFR)|Best available=local lab results when core lab results not available|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mL/min/1.73m^2||Standard Deviation|Mean
777237|NCT00763867|Other Pre-specified|ECHO Pulmonary Artery Systolic Pressure|A decrease in Pulmonary Artery Systolic Pressure is considered to be an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mmHg||Standard Deviation|Mean
777238|NCT00763867|Other Pre-specified|MRI Aortic Distensibility|An increase in Aortic Distensibility is considered to be an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||cm^2*dyne-1||Standard Deviation|Mean
777239|NCT00763867|Other Pre-specified|MRI Aortic Thickness|A decrease in Aortic Thickness is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mm||Standard Deviation|Mean
777240|NCT00763867|Other Pre-specified|MRI Systemic Vascular Resistance|A decrease in Systemic Vascular Resistance is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||Woods units||Standard Deviation|Mean
777241|NCT00763867|Other Pre-specified|MRI Effective Arterial Elastance|A decrease in Effective Arterial Elastance is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||Farads-1||Standard Deviation|Mean
777242|NCT00763867|Other Pre-specified|ECHO Systemic Vascular Resistance|A decrease in Systemic Vascular Resistance is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||Woods units||Standard Deviation|Mean
777243|NCT00763867|Other Pre-specified|ECHO Effective Arterial Elastance|A decrease in Effective Arterial Elastance is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||Farads-1||Standard Deviation|Mean
777244|NCT00763867|Other Pre-specified|Lateral Filling Pressure|A decrease in lateral filling pressure is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||m/sec||Standard Deviation|Mean
777245|NCT00763867|Other Pre-specified|Medial Filling Pressure|A decrease in medial filling pressure is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||m/sec||Standard Deviation|Mean
777246|NCT00763867|Other Pre-specified|Lateral Left Ventricular Relaxation|An increase in Left Ventricular relaxation is considered to be an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||m/sec||Standard Deviation|Mean
777247|NCT00763867|Other Pre-specified|Medial Left Ventricular Relaxation|An increase in Left Ventricular relaxation is considered to be an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||m/sec||Standard Deviation|Mean
777248|NCT00763867|Other Pre-specified|Lateral Diastolic Elastance|A decrease in Lateral Diastolic Elastance is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||(m/sec)/cc||Standard Deviation|Mean
777249|NCT00763867|Other Pre-specified|Medial Diastolic Elastance|A decrease in Medial Diastolic Elastance is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||(m/sec)/cc||Standard Deviation|Mean
777250|NCT00763867|Other Pre-specified|Echocardiogram Left Ventricular Mass|A decrease in Left Ventricular Mass is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||gm||Standard Deviation|Mean
777251|NCT00763867|Other Pre-specified|MRI Left Ventricular Ejection Fraction (LVEF)|An increase in LVEF is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||percentage of volume||Standard Deviation|Mean
777252|NCT00763867|Other Pre-specified|MRI Left Ventricular End Systolic Volume Index|An increase in Left Ventricular End Systolic Volume Index is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mL/m^2||Standard Deviation|Mean
777253|NCT00763867|Other Pre-specified|MRI Left Ventricular End Diastolic Volume Index|An increase in Left Ventricular End Diastolic Volume Index is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mL/m^2||Standard Deviation|Mean
777254|NCT00763867|Other Pre-specified|MRI Left Ventricular End Diastolic Volume|An increase in Left Ventricular End Diastolic Volume is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mL||Standard Deviation|Mean
777255|NCT00763867|Other Pre-specified|MRI Left Ventricular Mass Index|A decrease in Left Ventricular Mass Index is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||gm/m^2||Standard Deviation|Mean
777256|NCT00763867|Other Pre-specified|MRI Left Ventricular Mass|A decrease in LV Mass is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||gm||Standard Deviation|Mean
777257|NCT00763867|Secondary|Minnesota Living With Heart Failure Questionnaire|The MLWHFQ is a self-administered, disease-specific measure of health related quality of life (QOL) that assesses patients perceptions of the influence of heart failure on physical, socioeconomic and psychological aspects of life. Patients respond to 21 items using a six-point response scale (0-5). The total summary score can range from 0-105 with a lower score reflecting better heart failure related QOL. Two sub-scale scores reflect physical (8 items) and emotional (5 items) impairment.|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||units on a scale||Standard Deviation|Mean
777275|NCT00763919|Secondary|Change in Symptoms of Bipolar Disorder as Measured by the Brief Psychiatric Rating Scale (BPRS)|The minimum score is 18 and the maximum score is 126. A higher score implies a worse condition.|baseline and 3 months|Number of participants for analysis was based on all available data at the three month time point.||units on a scale||Standard Error|Mean
777258|NCT00763867|Secondary|Minnesota Living With Heart Failure Questionnaire (MLWHFQ)|"The MLWHFQ is a self-administered, disease-specific measure of health related quality of life (QOL) that assesses patients perceptions of the influence of heart failure on physical, socioeconomic and psychological aspects of life. Patients respond to 21 items using a six-point response scale (0-5). The total summary score can range from 0-105 with a lower score reflecting better heart failure related QOL. Two sub-scale scores reflect physical (8 items) and emotional (5 items) impairment.
Total score: 0 – 105 Physical subscore: 0 – 40 Emotional subscore: 0 – 25"|Change from Baseline to Week 12|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||units on a scale||Standard Deviation|Mean
777259|NCT00763867|Secondary|Ventilatory Anaerobic Threshold|To interpret the Ventilatory Anaerobic Threshold (VAT) change endpoints, an increase in VAT between Baseline and Week 12/Week 24 is considered to be an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||ml/min/kg||Standard Deviation|Mean
777260|NCT00763867|Secondary|Ventilatory Anaerobic Threshold|To interpret the Ventilatory Anaerobic Threshold (VAT) change endpoints, an increase in VAT between Baseline and Week 12/Week 24 is considered to be an improvement|Change from Baseline to Week 12|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||ml/min/kg||Standard Deviation|Mean
777261|NCT00763867|Secondary|Cardiopulmonary Exercise Test (CPET) Duration|To interpret the CPET Exercise Duration change endpoints, an increase in exercise duration between Baseline and Week 12/Week 24 is considered to be an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||minutes||Standard Deviation|Mean
777262|NCT00763867|Secondary|Cardiopulmonary Exercise Test (CPET) Duration|To interpret the CPET Exercise Duration change endpoints, an increase in exercise duration between Baseline and Week 12/Week 24 is considered to be an improvement|Change from Baseline to Week 12|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||minutes||Standard Deviation|Mean
777263|NCT00763867|Secondary|Exercise Capacity as Determined by Walk Distance|6 minute walk distance|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||meters||Standard Deviation|Mean
777264|NCT00763867|Secondary|Composite Score Reflective of Clinical Status|"Participants ranked sequentially with ranking stratified in one of three tiers based on:
Death (lowest tier) The person with the shortest time from randomization to death is given the lowest rank within the tier.
Hospitalizations due to cardiovascular or renal causes (middle tier) For patients alive, the ranking within this tier is based on time to hospitalization from randomization date. The person with the first cardiovascular or renal cause hospitalization will be given the lowest rank within the tier.
Change in Minnesota Living with Heart Failure Questionnaire (MLWHFQ) from baseline (highest tier)
The use of three tiers within the ranking reflects the greater adverse impact of death or cardiovascular hospitalization on clinical status without an arbitrary assignment as to the relative value of these events in relation to changes in quality of life. Rank order: 1-189 (higher values are better)"|Measured at Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||units on a scale||Standard Deviation|Mean
777265|NCT00763867|Secondary|Exercise Capacity as Determined by Walk Distance|6 Minute Walk Distance|Change from Baseline to Week 12|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||meters||Standard Deviation|Mean
777266|NCT00763867|Secondary|Exercise Capacity, as Determined by Peak Oxygen Uptake||Change from Baseline to Week 12|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||ml/min/kg||Standard Deviation|Mean
777267|NCT00763867|Primary|Exercise Capacity, as Determined by Peak Oxygen Uptake||Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||ml/min/kg||Standard Deviation|Mean
777268|NCT00763919|Secondary|Change in Perception of Mental Health as Measured by the 12-item Short Form Health Survey (SF-12)|The minimum score is 1 and the maximum score is 99. A higher score implies higher perceived physical health.|baseline and 3 months|Number of participants for analysis was based on all available data at the three month time point.||units on a scale||Standard Error|Mean
777269|NCT00763919|Secondary|Change in Perception of Physical Health as Measured by the 12-item Short Form Health Survey (SF-12)|The minimum score is 1 and the maximum score is 99. A higher score implies higher perceived physical health.|baseline and 3 months|Number of participants for analysis was based on all available data at the three month time point.||units on a scale||Standard Error|Mean
777270|NCT00763919|Primary|Change in Treatment Adherence Within the Past Week as Measured by the Tablet Routines Questionnaire|The minimum score is 0 and the maximum score is 100. A higher score implies poorer treatment adherence.|baseline and 3 months|Number of participants for analysis was based on all available data at the three month time point.||units on a scale||Standard Error|Mean
777271|NCT00763919|Secondary|Change in Attitude as Measured by the Rating of Medication Influences (ROMI)|The minimum score is 0 and the maximum score is 10. A higher score implies a poorer attitude.|baseline and 3 months|Number of participants for analysis was based on all available data at the three month time point.||units on a scale||Standard Error|Mean
777272|NCT00763919|Secondary|Change in Attitude as Measured by the Attitude Toward Mood Stabilizers Questionnaire (AMSQ)|The AMSQ is a modification of the Lithium Attitudes Questionnaire. The minimum score is 0 and the maximum score is 19. A higher score implies a poorer attitude.|baseline and 3 months|Number of participants for analysis was based on all available data at the three month time point.||units on a scale||Standard Error|Mean
777273|NCT00763919|Secondary|Change in Functional Status as Measured by the Global Assessment of Functioning (GAF) Scale|The minimum score is 1 and the maximum score is 100. A higher score implies higher functioning.|baseline and 3 months|Number of participants for analysis was based on all available data at the three month time point.||units on a scale||Standard Error|Mean
777274|NCT00763919|Secondary|Change in Global Psychopathology as Measured by the Clinical Global Impression for Bipolar Disorder (CGI-BP)|The minimum score is 1 and the maximum score is 7. A higher score implies a worse condition.|baseline and 3 months|Number of participants for analysis was based on all available data at the three month time point.||units on a scale||Standard Error|Mean
777276|NCT00763919|Secondary|Change in Symptoms of Bipolar Disorder as Measured by the Young Mania Rating Scale (YMRS)|The minimum score is 0 and the maximum score is 60. A higher score implies a worse condition.|baseline and 3 months|Number of participants for analysis was based on all available data at the three month time point.||units on a scale||Standard Error|Mean
777277|NCT00763919|Secondary|Change in Depression as Measured by the Hamilton Rating Scale for Depression (HAM-D)|The minimum score is 0 and the maximum score is 52. A higher score implies a worse condition.|baseline and 3 months|Number of participants for analysis was based on all available data at the three month time point.||units on a scale||Standard Error|Mean
777278|NCT00763919|Secondary|Change in Perception of Mental Health as Measured by the 12-item Short Form Health Survey (SF-12)|The minimum score is 1 and the maximum score is 99. A higher score implies higher perceived mental health.|baseline and 6 months|Number of participants for analysis was based on all available data at the six month time point.||units on a scale||Standard Error|Mean
777279|NCT00763919|Secondary|Change in Perception of Physical Health as Measured by the 12-item Short Form Health Survey (SF-12)|The minimum score is 1 and the maximum score is 99. A higher score implies higher perceived physical health.|baseline and 6 months|Number of participants for analysis was based on all available data at the six month time point.||units on a scale||Standard Error|Mean
777280|NCT00763919|Secondary|Change in Functional Status as Measured by the Global Assessment of Functioning (GAF) Scale|The minimum score is 1 and the maximum score is 100. A higher score implies higher functioning.|baseline and 6 months|Number of participants for analysis was based on all available data at the six month time point.||units on a scale||Standard Error|Mean
777281|NCT00763919|Secondary|Change in Global Psychopathology as Measured by the Clinical Global Impression for Bipolar Disorder (CGI-BP)|The minimum score is 1 and the maximum score is 7. A higher score implies a worse condition.|baseline and 6 months|Number of participants for analysis was based on all available data at the six month time point.||units on a scale||Standard Error|Mean
777282|NCT00763919|Secondary|Change in Symptoms of Bipolar Disorder as Measured by the Brief Psychiatric Rating Scale (BPRS)|The minimum score is 18 and the maximum score is 126. A higher score implies a worse condition.|baseline and 6 months|Number of participants for analysis was based on all available data at the six month time point.||units on a scale||Standard Error|Mean
777283|NCT00763919|Secondary|Change in Symptoms of Bipolar Disorder as Measured by the Young Mania Rating Scale (YMRS)|The minimum score is 0 and the maximum score is 60. A higher score implies a worse condition.|baseline and 6 months|Number of participants for analysis was based on all available data at the six month time point.||units on a scale||Standard Error|Mean
777284|NCT00763919|Secondary|Change in Depression as Measured by the Hamilton Rating Scale for Depression (HAM-D)|The minimum score is 0 and the maximum score is 52. A higher score implies a worse condition.|baseline and 6 months|Number of participants for analysis was based on all available data at the six month time point.||units on a scale||Standard Error|Mean
777285|NCT00763919|Secondary|Change in Attitude as Measured by the Rating of Medication Influences (ROMI)|The minimum score is 0 and the maximum score is 10. A higher score implies a poorer attitude.|baseline and 6 months|Number of participants for analysis was based on all available data at the six month time point.||units on a scale||Standard Error|Mean
777286|NCT00763919|Secondary|Change in Attitude as Measured by the Attitude Toward Mood Stabilizers Questionnaire (AMSQ)|The AMSQ is a modification of the Lithium Attitudes Questionnaire. The minimum score is 0 and the maximum score is 19. A higher score implies a poorer attitude.|baseline and 6 months|Number of participants for analysis was based on all available data at the six month time point.||units on a scale||Standard Error|Mean
777287|NCT00763919|Primary|Change in Treatment Adherence Within the Past Month as Measured by the Tablet Routines Questionnaire|The minimum score is 0 and the maximum score is 100. A higher score implies poorer treatment adherence.|baseline and 3 months|Number of participants for analysis was based on all available data at the three month time point.||units on a scale||Standard Error|Mean
777288|NCT00763919|Primary|Change in Treatment Adherence as Measured by the Morisky Scale|The minimum score is 0 and the maximum score is 4. A higher score implies poorer treatment adherence.|baseline and 6 months|Number of participants for analysis was based on all available data at the six month time point.||units on a scale||Standard Error|Mean
777289|NCT00763919|Primary|Change in Treatment Adherence Within the Past Week as Measured by the Tablet Routines Questionnaire|The minimum score is 0 and the maximum score is 100. A higher score implies poorer treatment adherence.|baseline and 6 months|Number of participants for analysis was based on all available data at the six month time point.||units on a scale||Standard Error|Mean
777290|NCT00763919|Primary|Change in Treatment Adherence Within the Past Month as Measured by the Tablet Routines Questionnaire|The minimum score is 0 and the maximum score is 100. A higher score implies poorer treatment adherence.|baseline and 6 months|Number of participants for analysis was based on all available data at the six month time point.||units on a scale||Standard Error|Mean
777291|NCT00763958|Primary|Opiate Positive Urines With Missing Urines Coded as Positive at Week 24.|Number of participants with positive opiate urine sample at the 24 week follow-up.|24 weeks|All subjects were included in the analysis population as intent to treat.||participants|||Number
777292|NCT00763958|Secondary|Number of Participants Who Enroll in the Study.|To determine the number of participants who enroll in the study during the time of recruitment.|up to 24 months|||participants|||Number
777293|NCT00763958|Primary|Opiate Positive Urines With Missing Urines Coded as Positive at Week 12.|Number of participants with positive opiate urine samples at 12 weeks of treatment.|12 weeks|All subjects were included in the analysis population as intent to treat.||participants|||Number
777294|NCT00763971|Secondary|Columbia-Suicide Severity Rating Scale (C-SSRS)|C-SSRS is a 19-item semi-structured interview designed to capture suicide-related thoughts and behaviors.|Up to 7 weeks|Safety Population||participants|||Number
777295|NCT00763971|Secondary|Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRS-C) Total Score at up to 7 Weeks|The BPRS-C characterizes psychopathology. A total of 21 items are rated on a scale from 0 (not present) to 6 (extremely severe) with a total score ranging from 0 to 126. A decrease in score indicates a reduction in psychopathology.|Baseline and up to 7 weeks|Safety Population defined as all subjects who took at least 1 dose of investigational product.||Scores on a scale||Standard Deviation|Mean
791692|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Creatine Phosphokinase [CPK])||Baseline up to Month 7|||percentage of participants|||Number
777296|NCT00763971|Secondary|Change From Baseline in Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at up to 7 Weeks|The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.|Baseline and up to 7 weeks|FAS||Scores on a scale||Standard Error|Least Squares Mean
777297|NCT00763971|Secondary|Change From Baseline in the Child Health and Illness Profile, Child Edition: Parent Report Form (CHIP-CE:PRF) Global T-score at up to 7 Weeks|The CHIP-CE:PRF evaluates health-related quality of life. It is composed of 5 domains (satisfaction, comfort, resilience, avoidance, and achievement) consisting of a total of 76 items. The global score is an average of the scores for the 5 domains. The majority of items assess frequency of events using a 5-point response format. There is no range for a total score. Raw scale scores are used to generate T-scores. Higher scores indicate better health.|Baseline and up to 7 weeks|FAS||T-scores||Standard Error|Least Squares Mean
777298|NCT00763971|Secondary|Health Utilities Index-2 (HUI-2) Scores at up to 7 Weeks|HUI is used to describe health status and to obtain utility scores by collecting data using one or more questionnaires in formats selected to match the specific study design criteria. Scoring ranges from 0.00 (dead) to 1.00 (perfect health). Higher scores represent better health status.|Baseline and up to 7 weeks|FAS||Scores on a scale||Standard Deviation|Mean
777299|NCT00763971|Secondary|Change From Baseline in Conner's Parent Rating Scale - Revised (CPRS-R) Total Score at up to 7 Weeks|The Conner's Parent rating Scale-revised short version (CPRS-R) consists of 27 questions graded on a scale from 0 (not true at all) to 3 (very much true) with a total score ranging from 0 to 81. Higher scores are indicative of increased ADHD. This scale allows parents to respond on the basis of the child's behavior and help assess ADHD and evaluate problem behavior.|Baseline and up to 7 weeks|FAS||Scores on a scale||Standard Error|Least Squares Mean
777300|NCT00763971|Secondary|Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|Up to 7 weeks|FAS||percentage of participants|||Number
777301|NCT00763971|Primary|Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at up to 7 Weeks|The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. A decrease in score indicates an improvement in ADHD symptomology.|Baseline and up to 7 weeks|Full Analysis set (FAS) defined as all subjects who were randomized and who took at least 1 dose of investigational product.||Scores on a scale||Standard Error|Least Squares Mean
777302|NCT00764309|Primary|Laboratory Test Results Summary of Toxicity: Blood Chemistry Per (NCI-CTCAE) Version 3.0 Grade (GR)|GR0=normal,1=mild,2=moderate,3=severe,4=life-threatening. ALP(U/L) GR0:40-135,GR1:>135-337; ALT(U/L) GR0:0-47,GR1:>47-117; AST(U/L) GR0:0-37,GR1:>37-93; High(↑) Calcium(mg/dL) GR0:8.4-10.2,GR1:>10.2-11.5; Low(↓) Calcium(mg/dL) GR0:8.4-10.2,GR1:<8.4-8.0,GR2:7.0-<8.0; CK(U/L) GR0:24-195,GR1:>195-488, GR2:>488-975; Creatinine(mg/dL) GR0:0.6-1.4,GR1:>1.4-2.1,GR2:>2.1-4.2; ↑Potassium(mEq/L) GR0:3.6-5.2,GR1:>5.2-5.5,GR2:>5.5-6.0; ↑Sodium(mEq/L) GR0:134-146; ↓Sodium(mEq/L) GR0:134-146,GR1:<134-130; Inorganic Phosphorus(mg/dL) GR0:2.4-4.9,GR2:≥2.0-<2.5; Total Bilirubin(mg/dL) GR0:0-1.1,GR1:>1.1-2.75.|From start of study drug therapy up to 30 days after the last dose. The duration of dasatinib dosing in this study was up to 2 years|All treated participants.||participants|||Number
777303|NCT00764309|Primary|Laboratory Test Results Summary of Toxicity: Hematology|Toxicity was graded as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 3.0. (Grade (GR)0=normal, GR1=mild, GR2=moderate, GR3=severe, GR4=life threatening). Granulocyte count (x 10^9 /L), GR1: ≥1.0 - <1.5, GR2: ≥0.5 - <1.0; Hemoglobin (g/dL), GR0: 13-17, GR1: <13 - 10.0 , GR2: 8.0 - <10.0, GR3: 6.5 - <8.0; Platelet count (x 10^9 /L) GR0: 150-400, GR2: ≥50.0 - <75.0; Leukocyte count (x 10^9 /L ), GR0: 3.5-11.1, GR2: 2.0 - <3.0.|From start of study drug therapy up to 30 days after the last dose. The duration of dasatinib dosing in this study was up to 2 years|All treated participants.||participants|||Number
777304|NCT00764309|Primary|Reasons for Discontinuation of Study Treatment|"Participants who discontinued the study due to any AEs were recorded.
Significant drug-related discontinuations were those SAEs recorded on the SAE case report forms with relationship to study drug of related or missing and action taken regarding study drug of discontinued or missing."|From start of study drug therapy up to 30 days after the last dose. The duration of dasatinib dosing in this study was up to 2 years|All treated participants.||Participants|||Number
777305|NCT00764309|Primary|Number of Participants Who Died, Experienced Serious Adverse Events (SAEs), or Adverse Events (AEs)|AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to any AEs were recorded.|From start of study drug therapy up to 30 days after the last dose. The duration of dasatinib dosing in this study was up to 2 years|All treated participants.||Participants|||Number
777306|NCT00764322|Secondary|Patient Understanding of Pharmacogenomics|To examine patients' beliefs about how hypothetical genotype information would affect their perceived recurrence risk and benefits of tamoxifen therapy, participants were given experimentally manipulated 6 vignettes to describe hypothetical tamoxifen treatment (no or yes) and hypothetical genotype (EM, IM or PM). For each vignette, participants gave their perceived recurrence risk (RR; 0-100%)|baseline|Of 377 patients who were eligible to complete the survey, 320 patients completed the survey and 57 returned incomplete surveys||percent chance of recurrence||Full Range|Mean
777307|NCT00764322|Secondary|Change in Plasma Endoxifen Levels After an Increase in Tamoxifen Citrate Dose From 20 mg to 40 mg Daily in Patients With Poor-metabolizing Genotypes|The intrapatient change in median endoxifen levels were calculated between baseline and 4 months after the increase in dose of Tamoxifen from 20mg/day to 40 mg/day|Baseline and 4 months after dose increase|Analysis limited to only those subjects with the Poor Metabolizing (PM) genotype who were evaluable at baseline||ng/mL||Inter-Quartile Range|Median
777395|NCT00764881|Secondary|Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 1|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Percentage of participants|||Number
777308|NCT00764322|Secondary|CYP2D6 Allele Frequencies and Endoxifen Levels Among African-American Women Taking Tamoxifen Citrate|Mean endoxifen levels by CYP2D6 genotype among African Americans. Measurements of plasma concentrations of the key active metabolite of tamoxifen, endoxifen, were measured at baseline.The most common CYP2D6 alleles have been grouped by functional activity classifications with descending activity: ultra-rapid (UM), extensive (EM), intermediate (IM) or poor (PM) metabolism. A given patient has two alleles, giving them 10 possible allelic combinations, or diplotypes (UM/UM, UM/EM, EM/EM, etc.). These diplotypes are collapsed into four phenotypes, UM, EM, IM or PM.|baseline|Only participants who self-identified as African American were included in this analysis||ng/ml||Full Range|Mean
777309|NCT00764322|Secondary|Change in Median Endoxifen Concentrations to Determine Feasibility of Obtaining Pharmacogenomic Information From Patients in the Clinical Setting and Using it to Guide Changes in Therapy|If the key active tamoxifen metabolite, endoxifen, could be significantly increased by genotype-guided tamoxifen dosing in patients with intermediate CYP2D6 metabolism (by increasing tamoxifen dosing based on CYP2D6 genotype), then the study would be deemed feasible and the accrual expanded.|Baseline and 4 months after dose increase|This was based on the initial 119 subjects enrolled (based on initial sample size of 100) and of those, the 89 that completed 4 months of tamoxifen therapy||ng/mL||Inter-Quartile Range|Median
777310|NCT00764322|Secondary|Number of Participants With Pulmonary Embolism (PE), Deep Vein Thrombosis (DVT), Stroke, and/or Endometrial Cancer|"The doubling of tamoxifen dose is defined as unacceptable (i.e., not tolerable) if the prevalence of Pulmonary embolism (PE), Deep vein thrombosis (DVT), stroke, or endometrial cancer, either individually or in any combination, is greater than 2%."|Approximately ten months from registration to last follow-up|Incidence of unacceptable adverse events among all patients who completed study||Participants|||Count of Participants
777311|NCT00764322|Primary|Endoxifen Concentrations in Participants Receiving Tamoxifen Citrate Dose of 20 mg or 40 mg Stratified by the Metabolizing CYP2D6 Genotypes|Measurements of plasma concentrations of the key active metabolite of tamoxifen, endoxifen, were measured at baseline and after 4 months of treatment; The most common CYP2D6 alleles have been grouped by functional activity classifications with descending activity: ultra-rapid (UM), extensive (EM), intermediate (IM) or poor (PM) metabolism. A given patient has two alleles, giving them 10 possible allelic combinations, or diplotypes (UM/UM, UM/EM, EM/EM, etc.). These diplotypes are collapsed into four phenotypes, UM, EM, IM or PM.|4 months|Baseline measurements are reported on all 353 subjects, while the 4 month levels are reported only for patients who completed 4 months of treatment||ng/mL||Standard Deviation|Mean
777312|NCT00764361|Secondary|Analyze the Molecular Changes in Pro-inflammatory Cytokine Levels That Occur in Diabetic Foot Ulcers as a Function of Healing Rate in the Presence /Absence of NanoDOX Hydrogel (1% Doxycycline Monohydrate Gel)||baseline, week 4, week 10, week 20||||||
777313|NCT00764361|Primary|Number of Participants Without Adverse Events|Participants were monitored for 20 weeks during the study.|every 2 weeks|||participants|||Number
777314|NCT00764465|Primary|AUC: Steady-state Plasma MVC PK Following Administration of RTV|Amprenavir (APV) is the active ingredient/ metabolite of Fosamprenavir (FPV). MVC minimum concentration (Cmin), maximum concentration (Cmax), and area under the plasma concentration-time curve (AUC), as determined from MVC concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the period when MVC 300mg BID was administered with the FPV-Containing BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the period when MVC 300mg BID was administered with the FPV QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F.|Day 7 of the MVC 300mg BID regimen and Day 14 of the MVC 300mg/FPV 1400mg BID, MVC 300mg/FPV 700mg/RTV 100mg BID, and MVC 300mg BID Plus FPV 1400mg/RTV 100mg QD regimens|||ng•h/mL||90% Confidence Interval|Mean
777315|NCT00764465|Primary|Cmin/Cmax: Steady-state Plasma MVC PK Following Administration of RTV|Amprenavir (APV) is the active ingredient/ metabolite of Fosamprenavir (FPV). MVC minimum concentration (Cmin), maximum concentration (Cmax), and area under the plasma concentration-time curve (AUC), as determined from MVC concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the period when MVC 300mg BID was administered with the FPV-Containing BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the period when MVC 300mg BID was administered with the FPV QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F.|Day 7 of the MVC 300mg BID regimen and Day 14 of the MVC 300mg/FPV 1400mg BID, MVC 300mg/FPV 700mg/RTV 100mg BID, and MVC 300mg BID Plus FPV 1400mg/RTV 100mg QD regimens|||ng/mL||90% Confidence Interval|Mean
777316|NCT00764465|Secondary|Number of Participants Who Experienced an Adverse Event|"Safety/tolerability data collected included all adverse events (AEs) reported within the time frame of each regimen evaluated. The intent was to compare adverse events for each sequence and not for each regimen. The regimens for which AE information was culled were:
MVC 300mg BID alone
FPV 1400mg BID alone
FPV 700mg/RTV 100 mg BID alone
FPV 1400mg/RTV 100mg QD alone
FPV 1400mg BID combined with MVC 300mg BID
FPV 700mg/RTV 100 mg BID combined with MVC 300mg BID
FPV 1400mg/RTV 100mg QD combined with MVC 300mg BID The severity of reported AEs was graded according to DAIDS criteria, Version 1.0 (National Institute of Allergy and Infectious Diseases (NIAID). Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0. Division of Acquired Immunodeficiency Syndrome (DAIDS), Washington D.C.; 2004"|Day 0 through Day 49|||participants|||Number
777317|NCT00764465|Primary|AUC: Steady-state Plasma Amprenavir (APV) Pharmacokinetics ( PK) Following Admin of Fosamprenavir (FPV) 1400mg BID, FPV 700mg/Ritonavir (RTV) 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent (Maraviroc) MVC 300mg BID.|Amprenavir (APV) is the active ingredient/metabolite of Fosamprenavir (FPV).|Day 14 of the FPV 1400mg BID, FPV 1400mg/MVC 300mg BID, FPV 700mg/RTV 100mg BID, FPV 700mg/RTV 100mg/MVC 300mg BID, FPV 1400mg/RTV 100mg QD, and FPV 1400mg/RTV 100mg QD plus MVC 300mg BID regimens|||ng•h/mL||90% Confidence Interval|Mean
777417|NCT00764881|Secondary|Number of Spotting Only Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure.||episodes||Standard Deviation|Mean
777318|NCT00764465|Primary|Cmin/Cmax: Steady-state Plasma Amprenavir (APV) Pharmacokinetics ( PK) Following Admin of Fosamprenavir (FPV) 1400mg BID, FPV 700mg/Ritonavir (RTV) 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent (Maraviroc) MVC 300mg BID.|Amprenavir (APV) is the active ingredient/metabolite of Fosamprenavir (FPV).|Day 14 of the FPV 1400mg BID, FPV 1400mg/MVC 300mg BID, FPV 700mg/RTV 100mg BID, FPV 700mg/RTV 100mg/MVC 300mg BID, FPV 1400mg/RTV 100mg QD, and FPV 1400mg/RTV 100mg QD plus MVC 300mg BID regimens|||ng/mL||90% Confidence Interval|Mean
777319|NCT00764478|Secondary|Change From Baseline in PANSS Marder Factor Anxiety/Depression Symptom Score|PANSS Marder Factor Anxiety/Depression symptom score measures symptoms of schizophrenia and consists of responses to 4 items (G2,G3,G4,G6). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Anxiety/Depression symptom score sums the scores from all 4 items and ranges from 4 to 28, with a higher score indicating greater severity of symptoms. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 7, Day14, Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.||Score on a scale||Standard Error|Least Squares Mean
777320|NCT00764478|Secondary|Change From Baseline in PANSS Marder Factor Hostility/Excitement Symptom Score|PANSS Marder Factor Hostility/Excitement symptom score measures symptoms of schizophrenia and consists of responses to 4 items (P4,P7,G8,G14). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Hostility/Excitement symptom score sums the score from all 4 items and ranges from 4 to 28, with a higher score indicating greater severity of symptoms. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 7, Day 14, Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.||Score on a scale||Standard Error|Least Squares Mean
777321|NCT00764478|Secondary|Change From Baseline in PANSS Marder Factor Disorganized Thought Symptom Score|PANSS Marder Factor Disorganized Thought symptom score measures symptoms of schizophrenia and consists of responses to 7 items (P2,N5,G5,G10,G11,G13,G15). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Disorganized Thought symptom score sums the scores from all 7 items and ranges from 7 to 49, with a higher score indicating greater severity of symptoms. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 7, Day 14, Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.||Score on a scale||Standard Error|Least Squares Mean
777322|NCT00764478|Secondary|Change From Baseline in PANSS Marder Factor Negative Symptom Score|PANSS Marder Factor Negative symptom score measures symptoms of schizophrenia and consists of responses to 7 items (N1,N2,N3,N4,N6,G7,G16). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Negative symptom score sums the scores from all 7 items and ranges from 7 to 49, with a higher score indicating greater severity of symptoms. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 7, Day 14, Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.||Score on a scale||Standard Error|Least Squares Mean
777323|NCT00764478|Secondary|Change From Baseline in PANSS Marder Factor Positive Symptom Score|PANSS Marder Factor Positive symptom score measures symptoms of schizophrenia and consists of responses to 8 items (P1,P3,P5,P6,N7,G1,G9,G12). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Positive symptom score sums the scores from all 8 items and ranges from 8 to 56, with a higher score indicating greater severity of symptoms. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 7, Day 14, Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.||Score on a scale||Standard Error|Least Squares Mean
777324|NCT00764478|Secondary|Change From Baseline in PANSS General Psychopathology Subscale Score|PANSS General Psychopathology subscale measures symptoms of schizophrenia and consists of responses to 16 items (G1-G16). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS General Psychopathology subscale sums the scores from all 16 items and ranges from 16 to 112, with a higher score indicating greater severity of symptoms. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 7, Day 14, Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.||Score on a scale||Standard Error|Least Squares Mean
777325|NCT00764478|Secondary|Change From Baseline in PANSS Positive Subscale Score|PANSS Positive subscale measures symptoms of schizophrenia and consists of responses to 7 items (P1-P7). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Positive subscale sums the scores from all 7 items and ranges from 7 to 49, with a higher score indicating greater severity of symptoms. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 7, Day 14, Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.||Score on a scale||Standard Error|Least Squares Mean
777326|NCT00764478|Secondary|Change From Baseline in PANSS Negative Subscale Score|PANSS Negative subscale measures symptoms of schizophrenia and consists of responses to 7 items (N1-N7). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Negative subscale sums the scores from all 7 items and ranges from 7 to 49, with a higher score indicating greater severity of symptoms. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 7, Day 14, Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.||Score on a scale||Standard Error|Least Squares Mean
777396|NCT00764881|Secondary|Onset of Withdrawal Bleeding Episodes at Cycle 6|Onset of withdrawal bleeding was calculated from the end of the exposure to the progestogen component (Day 24 for EV/DNG and Day 21 for EE/LNG). Therefore the count for the onset started at each Cycle on Day 25 for EV/DNG and Day 22 for EE/LNG.|From Day 24 for EV/DNG and Day 21 for EE/LNG to Day 28 for Cycle 6|All participants in FAS with assessment for this outcome measure.||Days||Standard Deviation|Mean
777327|NCT00764478|Secondary|Change From Baseline in Positive And Negative Syndrome Scale (PANSS) Total Score|PANSS total score measures symptoms of schizophrenia and consists of responses to 30 items: 7 items from the positive subscale (P1-P7), 7 items from the negative subscale (N1-N7) and 16 items from the general psychopathology subscale (G1-G16). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS total score sums the scores from all 30 items, and ranges from 30 to 210, with a higher score indicating greater severity of symptoms. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 7, Day 14, Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.||Score on a scale||Standard Error|Least Squares Mean
777328|NCT00764478|Secondary|Percentage of Participants Who Are CGI-BP Improvement (CGI-BP-I) Responders of Depression Score|The CGI-BP-I depression is a score on a 7-point scale for assessing the change from preceding phase of depression symptoms of bipolar disorder during the treatment of an acute episode or in longer term illness prophylaxis. Compared to the baseline, the CGI-BP-I depression score ranges from 1 = very much improved since initiating treatment, to 7 = very much worse since initiating treatment. Missing data were imputed by LOCF. A CGI-BP-I responder had a score of 3 (minimally improved) or lower.|Day 2, Day 4, Day 7, Day 14, and Day 21|Randomized participants who received at least one dose of trial medication and had at least one post-baseline measurement, and had evaluable post-baseline measurement at timepoint.||Percentage of participants|||Number
777329|NCT00764478|Secondary|Percentage of Participants Who Are CGI-BP Improvement (CGI-BP-I) Responders of Mania Score|The CGI-BP-I mania is a score on a 7-point scale for assessing the change from preceding phase of mania symptoms of bipolar disorder during the treatment of an acute episode or in longer term illness prophylaxis. Compared to the baseline, the CGI-BP-I mania score ranges from 1 = very much improved since initiating treatment, to 7 = very much worse since initiating treatment. Missing data were imputed by LOCF. A CGI-BP-I responder had a score of 3 (minimally improved) or lower.|Day 2, Day 4, Day 7, Day 14, and Day 21|Randomized participants who received at least one dose of trial medication and had at least one post-baseline measurement, and had evaluable post-baseline measurement at timepoint.||Percentage of participants|||Number
777330|NCT00764478|Secondary|Percentage of Participants Who Are CGI-BP Improvement (CGI-BP-I) Responders of Overall Bipolar Illness Score|The CGI-BP-I overall is a score on a 7-point scale for assessing the change from preceding phase of overall symptoms of bipolar disorder during the treatment of an acute episode or in longer term illness prophylaxis. Compared to the baseline, the CGI-BP-I overall score ranges from 1 = very much improved since initiating treatment, to 7 = very much worse since initiating treatment. Missing data were imputed by LOCF. A CGI-BP-I responder had a score of 3 (minimally improved) or lower.|Day 2, Day 4, Day 7, Day 14, and Day 21|Randomized participants who received at least one dose of trial medication and had at least one post-baseline measurement, and had evaluable post-baseline measurement at timepoint.||Percentage of participants|||Number
777331|NCT00764478|Secondary|Change From Baseline in CGI-BP-S Depression Score|The CGI-BP-S depression is a score that assesses the severity of the depression component of bipolar illness. The score ranges on a scale from 1 to 7, where 1 is normal, and 7 is very severely ill. Missing data were imputed by LOCF. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 2, Day 4, Day 7, Day 14, and Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement, and had evaluable post-baseline measurement at timepoint.||Score on a scale||Standard Error|Least Squares Mean
777332|NCT00764478|Secondary|Change From Baseline in CGI-BP-S Mania Score|The CGI-BP-S mania is a score that assesses the severity of the mania component of bipolar illness. The score ranges on a scale from 1 to 7, where 1 is normal, and 7 is very severely ill. Missing data were imputed by LOCF. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 2, Day 4, Day 7, Day 14, and Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement, and had evaluable post-baseline measurement at timepoint. One participant from the Placebo BID arm missed a baseline measurement.||Score on a scale||Standard Error|Least Squares Mean
777333|NCT00764478|Secondary|Change From Baseline in CGI-BP-S Overall Score at Day 2, Day 4, Day 7, Day 14|The CGI-BP-S is a score that measures the severity of overall bipolar illness. The score ranges on a scale from 1 to 7, where 1 is normal, and 7 is very severely ill. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 2, Day 4, Day 7, Day 14|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement. One participant from the Placebo BID arm missed a baseline measurement.||Score on a scale||Standard Error|Least Squares Mean
777334|NCT00764478|Secondary|Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score|The MADRS measures depression and consists of 10 items, each rated on a scale from 0 to 6. The MADRS total score sums the scores from the 10 items, ranging from 0 to 60, with a higher numeric rating implying a greater degree of symptom severity. Missing data were imputed by LOCF. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 7 and Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement, and had evaluable post-baseline measurement at timepoint.||Score on a scale||Standard Error|Least Squares Mean
777335|NCT00764478|Secondary|Percentage of Participants Who Are Y-MRS Remitters at Day 2, Day 4, Day 7, Day 14, Day 21|Y-MRS consists of responses to the following 11 items: elevated mood, increased motor activity energy, sexual interest, sleep, language-thought disorder, appearance, insight, irritability, speech - rate and amount, content and disruptive-aggressive behavior. The scores from the 11 items are summed to give a total score ranging from 0 to 60, with a higher score indicating greater severity of symptoms. The analysis is based on a generalized linear mixed model (GLMM). Y-MRS remitters are defined as having a Y-MRS total score of 12 or lower.|Day 2, Day 4, Day 7, Day 14, Day 21|Randomized participants who received at least one dose of trial medication and had at least one post-baseline measurement, and had evaluable post-baseline measurement at timepoint.||Percentage of participants|||Number
777415|NCT00764881|Secondary|Mean Length of Spotting-only Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure.||Days||Standard Deviation|Mean
777336|NCT00764478|Secondary|Percentage of Participants Who Are Y-MRS Remitters at Day 21|Y-MRS consists of responses to the following 11 items: elevated mood, increased motor activity energy, sexual interest, sleep, language-thought disorder, appearance, insight, irritability, speech - rate and amount, content and disruptive-aggressive behavior. The 11 items are summed to give a total score ranging from 0 to 60, with a higher score indicating greater severity of symptoms. Missing data were imputed by LOCF. Y-MRS remitters are defined as having a Y-MRS total score of 12 or lower.|Day 21|Randomized participants who received at least one dose of trial medication and had at least one post-baseline measurement.||Percentage of participants|||Number
777337|NCT00764478|Secondary|Percentage of Participants Who Are Y-MRS Responders at Day 2, Day 4, Day 7, Day 14|Y-MRS consists of responses to the following 11 items: elevated mood, increased motor activity energy, sexual interest, sleep, language-thought disorder, appearance, insight, irritability, speech - rate and amount, content and disruptive-aggressive behavior. The scores from the 11 items are summed to give a total score ranging from 0 to 60, with a higher score indicating greater severity of symptoms. Missing data were imputed by LOCF. Y-MRS responders are defined as having a >= 50% decrease from baseline in Y-MRS total score.|Day 2, Day 4, Day 7, Day 14|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement, and had evaluable post-baseline measurement at timepoint.||Percentage of participants|||Number
777338|NCT00764478|Secondary|Change From Baseline in Y-MRS Total Score at Day 2, Day 4, Day 7 and Day 14|Y-MRS consists of responses to the following 11 items: elevated mood, increased motor activity energy, sexual interest, sleep, language-thought disorder, appearance, insight, irritability, speech - rate and amount, content and disruptive-aggressive behavior. The scores from the 11 items are summed to give a total score ranging from 0 to 60, with a higher score indicating greater severity of symptoms. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 2, Day 4, Day 7 and Day 14|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.||Score on a scale||Standard Error|Least Squares Mean
777339|NCT00764478|Secondary|Percentage of Participants Who Are Y-MRS Responders at Day 21|Y-MRS consists of responses to the following 11 items: elevated mood, increased motor activity energy, sexual interest, sleep, language-thought disorder, appearance, insight, irritability, speech - rate and amount, content and disruptive-aggressive behavior. The scores from the 11 items are summed to give a total score ranging from 0 to 60, with a higher score indicating greater severity of symptoms. Missing data were imputed by Last Observation Carried Forward (LOCF). Y-MRS responders are defined as having a >= 50% decrease from baseline in Y-MRS total score.|Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.||Percentage of participants|||Number
777340|NCT00764478|Secondary|Change From Baseline in Clinical Global Impression – Bipolar Mania – Severity of Illness (CGI-BP-S) Overall Score at Day 21|The CGI-BP-S is a score that measures the severity of overall bipolar illness. The score ranges on a scale from 1 to 7, where 1 is normal, and 7 is very severely ill. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement. One participant from the Placebo BID arm missed a baseline measurement.||Score on a scale||Standard Error|Least Squares Mean
777341|NCT00764478|Primary|Change From Baseline in Young Mania Rating Scale (Y-MRS) Total Score at Day 21|Y-MRS consists of responses to the following 11 items: elevated mood, increased motor activity energy, sexual interest, sleep, language-thought disorder, appearance, insight, irritability, speech - rate and amount, content and disruptive-aggressive behavior. The scores from the 11 items are summed to give a total score ranging from 0 to 60, with a higher score indicating greater severity of symptoms. The analysis is based on a mixed model repeated measures (MMRM) model. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.||Score on a scale||Standard Error|Least Squares Mean
777342|NCT00764504|Primary|Safety Assessment|Number of device related adverse events and device failures at the 2 year time frame.|2-year|Adverse events were collected for all subjects who received the RSP device whether or not they were removed from the study at a later date due to protocol violation or consent issues.||adverse events|||Number
777343|NCT00764504|Primary|Radiographic Failures|Radiographic failure is defined as a shift in the position of the component >3mm or 3 degrees, a fracture of the cement mantle, a fracture of the component, or a >2mm radiolucency completely around either prosthesis.|Post-operative, 3-month, 6-month, 1-year, 2-year|Number of subjects who came in for a 2 year visit and completed the x-ray portion of the exam.||participants|||Number
777344|NCT00764504|Primary|"Neer's Limited Goals"|To meet Neer's limited goals, a subject must report: none, slight or moderate pain with unusual activity and exhibit >90 degrees active forward elevation and exhibit >20 degrees of active external rotation.|2-year|The number of participants analyzed is based on the number of participants who completed the study at the 2 year time frame and who had complete data sets at the final visit.||participants|||Number
777345|NCT00764504|Primary|Have Surgery Again?|Subject satisfaction: subject's willingness to have surgery performed again if necessary.|2-year|The number of participants analyzed is based on the number of participants who completed the study at the 2 year time frame and who had complete data sets at the final visit.||participants|||Number
777346|NCT00764504|Primary|Subject Satisfaction With Surgery|Each subject had a chance to rate their satisfaction with surgery at each study interval.|2-year|The number of participants analyzed is based on the number of participants who completed the study at the 2 year time frame and who had complete data sets at the final visit.||participants|||Number
777347|NCT00764504|Primary|Average Range of Motion|Physician's assessment of a subject's range of motion in degrees.|2-year|The number of participants analyzed is based on the number of participants who completed the study at the 2 year time frame and who had complete data sets at the final visit.||Angle of Degrees of Shoulder Motion||Standard Deviation|Mean
777436|NCT00764881|Secondary|Vaginal Effects Evaluated by the Mean Absolute Values of Atrophy Symptom Questionnaire (ASQ) at Baseline|ASQ consists of 5 items which define the status of the vagina. The response format uses a 4-point scale from 0 (none) to 3 (severe).|At Baseline|FAS||Scores on a scale||Standard Deviation|Mean
777348|NCT00764504|Primary|American Shoulder and Elbow Surgeons Shoulder Score|"The patient self-report section of the ASES is a condition specific scale which is intended to measure functional limitations and pain of the shoulder. On a scale of 0 to 100, the use of their shoulder is measured with 0 = no use and 100 = full use. The assessment is done in two sections. One Pain (measured by the Visual Analog Pain Scale) and the second is a list of 10 questions referred to as the Activities of Daily Living. The results are calculated with the following equation:
[(10 – Visual analog scale pain score) x 5] + [(5/3) x Cumulative ADL score]"|2-year|The number of participants analyzed is based on the number of participants who completed the study at the 2 year time frame and who had complete data sets at the final visit.||Units on a scale||Standard Deviation|Mean
777349|NCT00764660|Secondary|Number of Participants Who Discontinued Study Drug Due to an AE|An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not related to the study drug.|Up to 12 weeks|The APT population consisted of all participants who received at least one dose of study drug.||Participants|||Number
777350|NCT00764660|Secondary|Number of Participants Who Experienced an Adverse Event (AE)|An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not related to the study drug.|Up to 16 weeks|The All-Participants-Treated (APT) population consisted of all participants who received at least one dose of study drug.||Participants|||Number
777351|NCT00764660|Secondary|Change From Baseline in Mood VAS Score|Participants were asked to answer the question: “Over the past week, how did you feel?” The 100 mm line of the VAS was anchored on the left by “Extremely bad” and on the right by “Extremely good”. Mood VAS scores could range from 0 to 100, with a higher VAS score reflecting a better outcome.|Baseline and Day 84|The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure.||Score on a Scale||95% Confidence Interval|Least Squares Mean
777352|NCT00764660|Secondary|Change From Baseline in Motivation VAS Score|Participants were asked to answer the question: “Over the past week, how motivated were you to stay alcohol abstinent?” The 100 mm line of the VAS was anchored on the left by “No motivation at all” and on the right by “Extremely motivated”. Motivation VAS scores could range from 0 to 100, with a higher score reflecting a better outcome.|Baseline and Day 84|The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure.||Score on a Scale||95% Confidence Interval|Least Squares Mean
777353|NCT00764660|Secondary|Change From Baseline in Craving Visual Analog Scale (VAS) Score|Rating of craving is included to assess a potential relationship between treatment and craving severity. Participants were asked to answer the question: “Over the past week, what has your desire or craving for an alcoholic beverage been at the time of day that you usually drink?” The 100 mm line of the VAS was anchored on the left by “No desire at all” and on the right by “Extreme desire”. Participants marked a spot on the line where they felt their craving severity fit best. Craving VAS scores could range from 0 to 100, with a lower VAS score reflecting a better outcome.|Baseline and Day 84|The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure.||Score on a Scale||95% Confidence Interval|Least Squares Mean
777354|NCT00764660|Secondary|Global Functioning: CGI - Therapeutic Effect|The CGI scale is a standardized tool used by investigators to rate the efficacy of study drug (therapeutic effect), taking into account the participant's clinical condition and the severity of side effects. The CGI scores could range from 1 to 7, with a lower score reflecting a better outcome.|Day 84|The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure.||Score on a Scale||Standard Deviation|Mean
777355|NCT00764660|Secondary|Global Functioning: Clinical Global Impression (CGI) - Severity of Illness|The CGI scale is a standardized tool used by investigators to rate the severity of illness, taking into account the participant's clinical condition and the severity of side effects. The CGI scores could range from 1 to 7, with a lower score reflecting a better outcome.|Day 84|The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure.||Score on a Scale||Standard Deviation|Mean
777356|NCT00764660|Secondary|Percentage of Participants With Complete Abstinence|Percentage of total abstinence is the percentage of participants who remained abstinent during the entire treatment period.|12 weeks|The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure.||Percentage of Participants|||Number
777357|NCT00764660|Secondary|Percentage of Abstinent Days|Percentage of abstinent days is the percentage of study days in which participants remained abstinent during the treatment period.|12 weeks|The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure.||Percentage of Days||95% Confidence Interval|Least Squares Mean
777358|NCT00764660|Secondary|Time to First Relapse Into Drinking|Time to relapse was defined as the time to first relapse into heavy drinking (TLFB). A Hazard Ratio (SCH 900435/Placebo) of <1 means that SCH 900435 has a lower risk of relapsing as compared to Placebo.|12 weeks|The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure.||Days||Standard Deviation|Mean
777359|NCT00764660|Secondary|Number of Lapses Into Any Drinking|An alcohol lapse was defined as any episode of alcohol consumption not classified as a relapse (TLFB).|12 weeks|The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure.||Lapses||Standard Deviation|Mean
777360|NCT00764660|Secondary|Number of Relapses Into Heavy Drinking|An alcohol relapse was defined as either a daily alcohol intake of 5 or more drinks for males and 4 or more drinks for females or an overall consumption of 14 drinks or more per week during at least 4 weeks (TLFB).|12 weeks|The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure.||Relapses||Standard Deviation|Mean
777416|NCT00764881|Secondary|Mean Length of Spotting-only Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure.||Days||Standard Deviation|Mean
777361|NCT00764660|Secondary|Number of Drinks Per Drinking Day|The amount of drinking was defined as drinks per drinking day (TLFB). Drinking day is a day on which an alcoholic drink is consumed, with ‘day’ being defined as the period between waking up and going to sleep; the end of a day may have crossed the time point of midnight.|12 weeks|The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure.||Drinks||95% Confidence Interval|Least Squares Mean
777362|NCT00764660|Primary|Percentage of Heavy Drinking Days|"Percentage of heavy drinking days was defined as days with ≥5 standard drinks for men and ≥4 standard drinks for women assessed by Alcohol Timeline Follow Back (TLFB) method. The Alcohol TLFB is a drinking assessment method that obtains estimates of daily drinking by means of an interview between investigator and participant. The TLFB assesses recent drinking behavior. On the TLFB, clients retrospectively estimate their daily alcohol consumption in standard drinks over a time period prior to the interview, and thus the measure provides quantitative estimates of alcohol use.
A drink is standardized to an equivalent to 25-30 cL of beer or wine coolers (5% alcohol), 12-15 cL of table wine (11-14% alcohol) and 4-6 cL of hard liquor/spirits (35-40% alcohol).
Percentage was calculated based on number of heavy drinking days divided by total number of days in the given 2-week interval."|12 weeks|The modified Intent-to-Treat (mITT) population consisted of all participants from the All-Participants-Treated (APT) population who had at least post randomization efficacy data for this outcome measure.||Percentage of Days||95% Confidence Interval|Least Squares Mean
777363|NCT00764673|Primary|Safety Assessment|Number of device related adverse events and device failures at the 2 year time frame.|2-year|All subjects in the study were evaluated for adverse events.||Events|||Number
777364|NCT00764673|Primary|Number of Participants With >2mm Wide at the Bone/Cement Interface or a >3 Degree or >3 mm Migration (Shift) of the Component.|Radiographic failure is defined as a complete radiolucent line > 2mm wide at the bone/cement interface or a >3 degree or >3 mm migration (shift) of the component.|2-year|The number of subjects who came in for a 2 year visit and completed the x-ray portion of the evaluation.||participants|||Number
777365|NCT00764673|Secondary|Oxford Knee Score|Questionnaire on the perceptions of patients about a total knee replacement. Score between 0 and 48 where: 0 to 19 may indicate severe knee arthritis, 20 to 29 may indicate moderate to severe knee arthritis, 30 to 39 may indicate mild to moderate knee arthritis and 40 to 48 may indicate satisfactory joint function.|2-year|The number of subjects who completed an Oxford Knee score questionnaire at the 2 year visit.||Units on a scale||Standard Deviation|Mean
777366|NCT00764673|Primary|Knee Society Function Score|The Knee Society Score includes a knee rating and function score. Patient function considers only walking distance and stair climbing, with deductions for walking aids. The maximum function score, which is also 100, is obtained by a patient who can walk an unlimited distance and go up and down stairs normally. Walking ability is expressed in blocks (approximately 100 meters). Stair climbing is considered normal if the patient can ascend and descend stairs without holding a railing. A score of > or = to 60 on the function score is considered success.|2-year|The number of subjects who completed their 2 year visit and had available data to collect for this evaluation.||Average Knee Function Score||Standard Deviation|Mean
777367|NCT00764673|Primary|Knee Society Score Evaluation|The Knee Society Score includes a knee rating and function score. This evaluation covers the knee rating score with three main parameters of pain, stability and range of motion and that flexion contracture, extension lag and misalignment should be dealt with as deductions. Thus, 100 points will be obtained by a well-aligned knee with no pain, 125 degrees of motion, and negligible anteroposterior and mediolateral instability. 50 points are allotted for pain, 25 for stability, and 25 for range of motion. Grading for KS Score: Excellent (90-100), Good (80-90), Fair (70-79) and Poor (<70).|2 year|The number of subjects who completed their 2 year visit.||Average Knee Rating Score||Standard Deviation|Mean
777368|NCT00764790|Secondary|Number of Subjects Reporting Rare Serious Events|Rare serious events have an occurrence rate of 1/300 (0.3%).|During the entire study (Day 0 until Month 6)|||subjects|||Number
777369|NCT00764790|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE) and New Onset of Chronic Diseases (NOCD)|"An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
NOCDs assessed include for example: diabetes, asthma, allergies, autoimmune disease, cancer, neuropathic disorders"|During the entire study (Day 0 until Month 6)|||subjects|||Number
777370|NCT00764790|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product|During a 28-day follow-up period after vaccination|||subjects|||Number
777371|NCT00764790|Secondary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed include drowsiness, irritability, loss of appetitie, and temperature.|During a 4-day follow-up period after vaccination|Analysis was performed on the Total Vaccinated Cohort, including all vaccinated subjects for whom data were available.||subjects|||Number
777372|NCT00764790|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling.|During a 4-day follow-up period after vaccination|Analysis was performed on the Total Vaccinated Cohort, including all vaccinated subjects for whom data were available.||subjects|||Number
777373|NCT00764790|Secondary|Seroconversion Factor|"Seroconversion factor is defined as the fold increase in serum anti-HA GMTs post-vaccination (Day 28 or 56) compared to pre-vaccination (Day 0).
Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects"|Day 28 or Day 56|Analysis was performed on the ATP cohort for analysis of immunogenicity||fold increase||95% Confidence Interval|Mean
777374|NCT00764790|Secondary|Number of Seroprotected Subjects|"A seroprotected subject is a subject with a serum anti-HA titer
≥ 1:40
Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects"|Day 0 (PRE), Day 28 or Day 56 (POST)|Analysis was performed on the ATP cohort for analysis of immunogenicity||subjects|||Number
777375|NCT00764790|Primary|Number of Subjects Who Seroconverted|"Seroconversion is defined as the number of subjects with either a pre-vaccination anti-HA titer < 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum 4-fold increase at post-vaccination titer.
Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects"|Day 28 or Day 56|Analysis was performed on the ATP cohort for analysis of immunogenicity||subjects|||Number
777376|NCT00764790|Primary|Geometric Mean Titer (GMT) of Serum Anti-hemagglutinin (HA) Antibodies Against Each of the Influenza Vaccine Strains|"GMTs and their 95% confidence interval are presented for all 3 viral strains comprised in the vaccine.
Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects"|Day 0 (PRE), Day 28 or Day 56 (POST)|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.||titre||95% Confidence Interval|Geometric Mean
777377|NCT00764868|Secondary|Change From Baseline (From the Antecedent Study, SPD489-305) in the Youth Quality of Life Instrument-Research Version (YQOL-R) Total Score at up to 52 Weeks|The Youth Quality of Life-research version (YQOL-R) is a validated 56-item generic instrument for comparing quality of life of adolescents across condition groups that scores each question on a scale from 0 (never) to 4 (very often). The YQOL scores are transformed to a 0-100 scale for easy interpretability. Higher scores indicate better quality of life.|Baseline and Up to 52 weeks|FAS||Units on a scale||Standard Deviation|Mean
777378|NCT00764868|Secondary|Percent of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I)|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|up to 52 weeks|FAS||Percent of participants|||Number
777379|NCT00764868|Primary|Change From Baseline (From the Antecedent Study, SPD489-305) in the Attention-Deficit/Hyperactivity Disorder Rating Scale, Fourth Edition (ADHD-RS-IV) Total Score at up to 52 Weeks|The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|Baseline and up to 52 weeks|Full Analysis Set (FAS) defined as all subjects who took at least 1 dose of investigational product and have a valid baseline and at least 1 valid follow-up assessment of the primary outcome measure.||Units on a scale||Standard Deviation|Mean
777380|NCT00764881|Secondary|Percentage of Participants With at Least 1 Intracyclic Bleeding Episode|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|Up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Percentage of participants|||Number
777381|NCT00764881|Secondary|Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 6|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity rated on 4-point scale where 1=spotting; 2=light; 3=normal; and 4=heavy.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Percentage of participants|||Number
777382|NCT00764881|Secondary|Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity rated on 4-point scale where 1=spotting; 2=light; 3=normal; and 4=heavy.|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Percentage of participants|||Number
777383|NCT00764881|Secondary|Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity rated on 4-point scale where 1=spotting; 2=light; 3=normal; and 4=heavy.|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Percentage of participants|||Number
777384|NCT00764881|Secondary|Number of Intracyclic Bleeding Days at Cycle 6|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Days||Standard Deviation|Mean
777385|NCT00764881|Secondary|Number of Intracyclic Bleeding Days at Cycle 3|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Days||Standard Deviation|Mean
777386|NCT00764881|Secondary|Number of Intracyclic Bleeding Days at Cycle 1|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Days||Standard Deviation|Mean
777387|NCT00764881|Secondary|Maximum Length of Intracyclic Bleeding Episodes at Cycle 6|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Days||Standard Deviation|Mean
777388|NCT00764881|Secondary|Maximum Length of Intracyclic Bleeding Episodes at Cycle 3|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Days||Standard Deviation|Mean
777389|NCT00764881|Secondary|Maximum Length of Intracyclic Bleeding Episodes at Cycle 1|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Days||Standard Deviation|Mean
777390|NCT00764881|Secondary|Number of Intracyclic Bleeding Episodes at Cycle 6|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||episodes||Standard Deviation|Mean
777391|NCT00764881|Secondary|Number of Intracyclic Bleeding Episodes at Cycle 3|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||episodes||Standard Deviation|Mean
777392|NCT00764881|Secondary|Number of Intracyclic Bleeding Episodes at Cycle 1|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||episodes||Standard Deviation|Mean
777393|NCT00764881|Secondary|Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 6|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Percentage of participants|||Number
777394|NCT00764881|Secondary|Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 3|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Percentage of participants|||Number
791693|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Total Bilirubin)||Baseline up to Month 7|||percentage of participants|||Number
777397|NCT00764881|Secondary|Onset of Withdrawal Bleeding Episodes at Cycle 3|Onset of withdrawal bleeding was calculated from the end of the exposure to the progestogen component (Day 24 for EV/DNG and Day 21 for EE/LNG). Therefore the count for the onset started at each Cycle on Day 25 for EV/DNG and Day 22 for EE/LNG.|From Day 24 for EV/DNG and Day 21 for EE/LNG to Day 28 for Cycle 3|All participants in FAS with assessment for this outcome measure.||Days||Standard Deviation|Mean
777398|NCT00764881|Secondary|Onset of Withdrawal Bleeding Episodes at Cycle 1|Onset of withdrawal bleeding was calculated from the end of the exposure to the progestogen component (Day 24 for EV/DNG and Day 21 for EE/LNG). Therefore the count for the onset started at each Cycle on Day 25 for EV/DNG and Day 22 for EE/LNG.|From Day 24 for EV/DNG and Day 21 for EE/LNG to Day 28 for Cycle 1|All participants in FAS with assessment for this outcome measure.||Days||Standard Deviation|Mean
777399|NCT00764881|Secondary|Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end. Intensity rated on 4-point scale from 1=spotting to 4=heavy.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Percentage of participants|||Number
777400|NCT00764881|Secondary|Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end. Intensity rated on 4-point scale from 1=spotting to 4=heavy.|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Percentage of participants|||Number
777401|NCT00764881|Secondary|Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end. Intensity rated on 4-point scale from 1=spotting to 4=heavy.|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Percentage of participants|||Number
777402|NCT00764881|Secondary|Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6|Intensity was rated as 1=spotting; 2=light; 3=normal or 4=heavy.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
777403|NCT00764881|Secondary|Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3|Intensity was rated as 1=spotting; 2=light; 3=normal or 4=heavy.|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
777404|NCT00764881|Secondary|Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1|Intensity was rated as 1=spotting; 2=light; 3=normal or 4=heavy.|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
777405|NCT00764881|Secondary|Length of Withdrawal Bleeding Episodes at Cycle 6|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Days||Standard Deviation|Mean
777406|NCT00764881|Secondary|Length of Withdrawal Bleeding Episodes at Cycle 3|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Days||Standard Deviation|Mean
777407|NCT00764881|Secondary|Length of Withdrawal Bleeding Episodes at Cycle 1|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Days||Standard Deviation|Mean
777408|NCT00764881|Secondary|Percentage of Participants With / Without Withdrawal Bleeding at Cycle 6|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Percentage of participants|||Number
777409|NCT00764881|Secondary|Percentage of Participants With / Without Withdrawal Bleeding at Cycle 3|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Percentage of participants|||Number
777410|NCT00764881|Secondary|Percentage of Participants With / Without Withdrawal Bleeding at Cycle 1|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Percentage of participants|||Number
777411|NCT00764881|Secondary|Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure.||Days||Standard Deviation|Mean
777412|NCT00764881|Secondary|Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure.||Days||Standard Deviation|Mean
777413|NCT00764881|Secondary|Maximum Length of Spotting-only Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure.||Days||Standard Deviation|Mean
777414|NCT00764881|Secondary|Maximum Length of Spotting-only Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure.||Days||Standard Deviation|Mean
777418|NCT00764881|Secondary|Number of Spotting Only Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure.||episodes||Standard Deviation|Mean
777419|NCT00764881|Secondary|Number of Spotting Only Days in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure.||Days||Standard Deviation|Mean
777420|NCT00764881|Secondary|Number of Spotting Only Days in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure.||Days||Standard Deviation|Mean
777421|NCT00764881|Secondary|Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure.||Days||Standard Deviation|Mean
777422|NCT00764881|Secondary|Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure.||Days||Standard Deviation|Mean
777423|NCT00764881|Secondary|Maximum Length of Bleeding / Spotting Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure.||Days||Standard Deviation|Mean
777424|NCT00764881|Secondary|Maximum Length of Bleeding / Spotting Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure.||Days||Standard Deviation|Mean
777425|NCT00764881|Secondary|Mean Length of Bleeding / Spotting Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure.||Days||Standard Deviation|Mean
777426|NCT00764881|Secondary|Mean Length of Bleeding / Spotting Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure.||Days||Standard Deviation|Mean
777427|NCT00764881|Secondary|Number of Bleeding / Spotting Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure.||episodes||Standard Deviation|Mean
777428|NCT00764881|Secondary|Number of Bleeding / Spotting Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the fist treatment cycle includes 2 bleeding episodes|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure.||episodes||Standard Deviation|Mean
777429|NCT00764881|Secondary|Number of Bleeding / Spotting Days in Reference Period 2|Reference Period 2 is defined as Day 91 to 180 during study treatment|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure.||Days||Standard Deviation|Mean
777430|NCT00764881|Secondary|Number of Bleeding / Spotting Days in Reference Period 1|Reference Period 1 is defined as Day 1 to 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure.||Days||Standard Deviation|Mean
777431|NCT00764881|Secondary|Vaginal Effects Evaluated by the Mean Change From Baseline to Cycle 6 in Vaginal Health Assessment (VHA)|The VHA, performed by the Investigator during gynecological exam, is the average of 5 individual scores related to composition and appearance of the vagina (secretions, epithelial integrity, epithelial surface thickness, color, and pH) scored from 0 (no atrophy or pH<4) to 3 (severe or pH5). The change in average score ranges from -3 (best) to 3 (worst).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
777432|NCT00764881|Secondary|Vaginal Effects Evaluated by the Mean Absolute Values of Vaginal Health Assessment (VHA) at Cycle 6|The VHA, performed by the Investigator during gynecological exam, is the average of 5 individual scores related to composition and appearance of the vagina (secretions, epithelial integrity, epithelial surface thickness, color, and pH) scored from 0 (no atrophy or pH<4) to 3 (severe or pH5).|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
777433|NCT00764881|Secondary|Vaginal Effects Evaluated by the Mean Absolute Values of Vaginal Health Assessment (VHA) at Baseline|The VHA, performed by the Investigator during gynecological exam, is the average of 5 individual scores related to composition and appearance of the vagina (secretions, epithelial integrity, epithelial surface thickness, color, and pH) scored from 0 (no atrophy or pH<4) to 3 (severe or pH5).|At Baseline|All participants in FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
777434|NCT00764881|Secondary|Vaginal Effects Evaluated by the Mean Change From Baseline to Cycle 6 in Atrophy Symptom Questionnaire (ASQ)|ASQ consists of 5 items which define the status of the vagina. The response format uses a 4-point scale from 0 (none) to 3 (severe). The change in average score ranges from -3 (best) to 3 (worst).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
777435|NCT00764881|Secondary|Vaginal Effects Evaluated by the Mean Absolute Values of Atrophy Symptom Questionnaire (ASQ) at Cycle 6|ASQ consists of 5 items which define the status of the vagina. The response format uses a 4-point scale from 0 (none) to 3 (severe).|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
777437|NCT00764881|Secondary|Vaginal Effects Evaluated by Vaginal pH at Cycle 6|Vaginal pH (0 to 6) measured by subject using a pH indicator dipstick|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Proportion of participants|||Number
777438|NCT00764881|Secondary|Percentage of Participants With Improvement in Participant's Assessment in Clinical Global Impression (CGI) at Cycle 6|In 1 section of the CGI the subject rates their total improvement and rate of satisfaction with sexuality during treatment. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Percentage of participants|||Number
777439|NCT00764881|Secondary|Percentage of Participants With Improvement in the Investigator's Assessment in Clinical Global Impression (CGI) at Cycle 6|CGI is used to collect information regarding the subject's total clinical experience. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Percentage of participants|||Number
777440|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) – Vitality|Vitality is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the change in the normalized PGWBI - vitality score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
777441|NCT00764881|Secondary|The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – Vitality at Cycle 6|Vitality is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
777442|NCT00764881|Secondary|The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – Vitality at Baseline|Vitality is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.|At Baseline|FAS||Scores on a scale||Standard Deviation|Mean
777443|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) – General Health|General health is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale the change in the normalized PGWBI general health score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
777444|NCT00764881|Secondary|The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – General Health at Cycle 6|General health is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
777445|NCT00764881|Secondary|The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – General Health at Baseline|General health is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.|At Baseline|FAS||Scores on a scale||Standard Deviation|Mean
777446|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) – Self-control|Self-control is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the change in the normalized PGWBI - self-control score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
777447|NCT00764881|Secondary|The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – Self-control at Cycle 6|Self-control is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
777448|NCT00764881|Secondary|The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – Self-control at Baseline|Self-control is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.|At Baseline|FAS||Scores on a scale||Standard Deviation|Mean
777449|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) – Positive Well-being|Positive well-being is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the change in the normalized PGWBI - positive well-being score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
777463|NCT00764881|Secondary|The Mean Absolute Values of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score at Baseline|Q-LES-Q (short version - 16 items) assessed at Baseline the degree of enjoyment and satisfaction during the past week taking everything into consideration on a 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best).|At Baseline|FAS||Scores on a scale||Standard Deviation|Mean
777450|NCT00764881|Secondary|The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – Positive Well-being at Cycle 6|Positive well-being is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
777451|NCT00764881|Secondary|The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – Positive Well-being at Baseline|Positive well-being is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.|At Baseline|FAS||Scores on a scale||Standard Deviation|Mean
777452|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) – Depressed Mood|Depressed mood is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the change in the normalized PGWBI - depressed mood score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
777453|NCT00764881|Secondary|The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – Depressed Mood at Cycle 6|Depressed mood is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
777454|NCT00764881|Secondary|The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – Depressed Mood at Baseline|Depressed mood is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.|At Baseline|FAS||Scores on a scale||Standard Deviation|Mean
777455|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) – Anxiety|Anxiety is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the change in the normalized PGWBI - Anxiety score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
777456|NCT00764881|Secondary|The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – Anxiety at Cycle 6|Anxiety is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
777457|NCT00764881|Secondary|The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – Anxiety at Baseline|Anxiety is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.|At Baseline|FAS||Scores on a scale||Standard Deviation|Mean
777458|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) Global Score|Change from Baseline to Cycle 6 in the PGWBI Questionnaire's assessment of the participant's overall sense of well-being or distress. The response format used a 6-grade Likert scale and the change in the normalized PGWBI global score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
777459|NCT00764881|Secondary|The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) Global Score at Cycle 6|The PGWBI measured at Cycle 6 self-representations over the past 4 weeks of intrapersonal affective or emotional states reflecting a sense of subjective well-being or distress. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the well-being of the participant|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
777460|NCT00764881|Secondary|The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) Global Score at Baseline|The PGWBI measured at Baseline self-representations over the past 4 weeks of intrapersonal affective or emotional states reflecting a sense of subjective well-being or distress. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the well-being of the participant|At Baseline|All participants in FAS with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
777461|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score|Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the QLES-Q (short version - 16 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
777462|NCT00764881|Secondary|The Mean Absolute Values of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score at Cycle 6|Q-LES-Q (short version - 16 items) assessed at Cycle 6 the degree of enjoyment and satisfaction during the past week taking everything into consideration on a 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best).|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
777464|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in Female Sexual Distress Scale (FSDS-R) Total Score|Change from Baseline to Cycle 6 in the validated, 13-item scale (0=never to 4=always) that assesses subjective distress associated with sexual dysfunction in women. A decrease in the total score=decrease in frequency of the subjective distress symptom. The change in total score ranges from -52 (best) to 52 (worst).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
777465|NCT00764881|Secondary|The Mean Absolute Values of Female Sexual Distress Scale (FSDS-R) Total Score at Cycle 6|Validated, 13-item scale (0=never to 4=always) that assesses subjective distress associated with sexual dysfunction in women. A decrease in the total score=decrease in frequency of the subjective distress symptom. The total score ranges from 0 (worst) to 52 (best).|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
777466|NCT00764881|Secondary|The Mean Absolute Values of Female Sexual Distress Scale (FSDS-R) Total Score at Baseline|Validated, 13-item scale (0=never to 4=always) that assesses subjective distress associated with sexual dysfunction in women. A decrease in the total score=decrease in frequency of the subjective distress symptom. The total score ranges from 0 (worst) to 52 (best).|At Baseline|FAS||Scores on a scale||Standard Deviation|Mean
777467|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in FSFI Total Score|The change in the normalized FSFI total score ranges from -34 (worst) to 34 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
777468|NCT00764881|Secondary|The Mean Absolute Values of FSFI Total Score at Cycle 6|The normalized FSFI total score was the weighted sum of the domain scores covering a range from 2 (worst) to 36 (best).|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
777469|NCT00764881|Secondary|The Mean Absolute Values of FSFI Total Score at Baseline|The normalized FSFI total score was the weighted sum of the domain scores covering a range from 2 (worst) to 36 (best).|At Baseline|FAS||scores on a scale||Standard Deviation|Mean
777470|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Pain)|Mean change from Baseline to Cycle 6 in the sum of questions 17 to 19 on pain on the FSFI Questionnaire. The change in the normalized score for those 3 questions ranges from -6 (worst) to 6 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
777471|NCT00764881|Secondary|The Mean Absolute Values of FSFI Domain Score (Pain) at Cycle 6|Sum of questions 17 to 19 on pain on the FSFI Questionnaire at Cycle 6. The normalized score for those 3 questions ranges from 0 (worst) to 6 (best).|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
777472|NCT00764881|Secondary|The Mean Absolute Values of FSFI Domain Score (Pain) at Baseline.|Sum of questions 17 to 19 on pain on the FSFI Questionnaire at Baseline. The normalized score for those 3 questions ranges from 0 (worst) to 6 (best).|At Baseline|FAS||Scores on a scale||Standard Deviation|Mean
777473|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Satisfaction)|Mean change from Baseline to Cycle 6 in the sum of questions 14 to 16 on satisfaction on the FSFI Questionnaire. The change in the normalized score for those 3 questions ranges from -5.2 (worst) to 5.2 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
777474|NCT00764881|Secondary|The Mean Absolute Values of FSFI Domain Score (Satisfaction) at Cycle 6|Sum of questions 14 to 16 on satisfaction on the FSFI Questionnaire at Cycle 6. The normalized score for those 3 questions ranges from 0.8 (worst) to 6 (best).|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
777475|NCT00764881|Secondary|The Mean Absolute Values of FSFI Domain Score (Satisfaction) at Baseline|Sum of Questions 14 to 16 on satisfaction on the FSFI Questionnaire at Baseline. The normalized score for those 3 questions ranges from 0.8 (worst) to 6 (best).|At Baseline|FAS||Scores on a scale||Standard Deviation|Mean
777476|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Orgasm)|Mean change from Baseline to Cycle 6 in the sum of questions 11 to 13 on orgasm on the FSFI Questionnaire. The change in the normalized score for those 3 questions ranges from -6 (worst) to 6 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
777477|NCT00764881|Secondary|The Mean Absolute Values of FSFI Domain Score (Orgasm) at Cycle 6|Sum of questions 11 to 13 on orgasm on the FSFI Questionnaire at Cycle 6. The normalized score for those 3 questions ranges from 0 (worst) to 6 (best).|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
777478|NCT00764881|Secondary|The Mean Absolute Values of FSFI Domain Score (Orgasm) at Baseline|Sum of questions 11 to 13 on orgasm on FSFI Questionnaire at Baseline. The normalized score for those 3 questions ranges from 0 (worst) to 6 (best).|At Baseline|FAS||Scores on a scale||Standard Deviation|Mean
777479|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Lubrication)|Mean change from Baseline at Cycle 6 in the sum of questions 7 to 10 on the FSFI Questionnaire. The change in the normalized score for those 4 questions ranges from -6 (worst) to 6 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
777480|NCT00764881|Secondary|The Mean Absolute Values of FSFI Domain Score (Lubrication) at Cycle 6|Sum of questions 7 to 10 on lubrication on the FSFI Questionnaire at Cycle 6. The normalized score for those 4 questions ranges from 0 (worst) to 6 (best).|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||scores on a scale||Standard Deviation|Mean
777481|NCT00764881|Secondary|The Mean Absolute Values of FSFI Domain Score (Lubrication) at Baseline|Sum of questions 7 to 10 on lubrication on the FSFI Questionnaire at Baseline. The normalized score for those 4 questions ranges from 0 (worst) to 6 (best).|At Baseline|FAS||Scores on a scale||Standard Deviation|Mean
778253|NCT00775203|Secondary|Discontinuation Due to Lack of Efficacy|Number of patients who discontinued due to lack of efficacy during the whole study period (8 weeks).|Baseline to Week 8|Safety population is defined as all randomized patients who received any study medication.||participants|||Number
777482|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Arousal)|Mean change from Baseline to Cycle 6 in the sum of questions 3 to 6 on sexual arousal on the FSFI Questionnaire. The change in the normalized score for those 4 questions ranges from -6 (worst) to 6 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||scores on a scale||Standard Deviation|Mean
777483|NCT00764881|Secondary|The Mean Absolute Values of FSFI Domain Score (Arousal) at Cycle 6|Sum of questions 3 to 6 on sexual arousal on FSFI Questionnaire at Cycle 6. The normalized score for those 4 questions ranges from 0 (worst) to 6 (best).|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||scores on a scale||Standard Deviation|Mean
777484|NCT00764881|Secondary|The Mean Absolute Values of FSFI Domain Score (Arousal) at Baseline|Sum of questions 3 to 6 on sexual arousal on the FSFI Questionnaire at Baseline. The normalized score for those 4 questions ranges from 0 (worst) to 6 (best).|At Baseline|FAS||scores on a scale||Standard Deviation|Mean
777485|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Desire)|Mean change from Baseline to Cycle 6 in the sum of questions 1 and 2 on sexual desire on the FSFI Questionnaire. The change in the normalized score for those 2 questions ranges from -4.8 (worst) to 4.8 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||scores on a scale||Standard Deviation|Mean
777486|NCT00764881|Secondary|The Mean Absolute Values of FSFI Domain Score (Desire) at Cycle 6|Sum of questions 1 and 2 on sexual desire on the FSFI Questionnaire at Cycle 6. The normalized score for those 2 questions ranges from 1.2 (worst) to 6 (best).|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||scores on a scale||Standard Deviation|Mean
777487|NCT00764881|Secondary|The Mean Absolute Values of FSFI Domain Score (Desire) at Baseline|Sum of questions 1 and 2 on sexual desire on the FSFI Questionnaire at Baseline. The normalized score for those 2 questions ranges from 1.2 (worst) to 6 (best).|At Baseline|FAS||scores on a scale||Standard Deviation|Mean
777488|NCT00764881|Primary|Change From Baseline to Cycle 6 in the Total of Questions 1 to 6 of the Female Sexual Function Index (FSFI) – Per Protocol Set (PPS)|Change from Baseline FSFI domains in desire and arousal component scores at Cycle 6. The change in score ranges from -28 (worst) to 28 (best).|Baseline up to Cycle 6 (28 days per Cycle)|Per Protocol Set (PPS) includes those participants of the FAS without major protocol deviations affecting the primary variables||scores on a scale||Standard Deviation|Mean
777489|NCT00764881|Primary|Change From Baseline to Cycle 6 in the Total of Questions 1 to 6 of the Female Sexual Function Index (FSFI) – Full Analysis Set (FAS)|Change from Baseline FSFI domains in desire and arousal component scores at Cycle 6. The change in score ranges from -28 (worst) to 28 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||scores on a scale||Standard Deviation|Mean
777490|NCT00764946|Primary|Number of Participants Who Discontinued Due to an Adverse Event|Numbers of participants who discontinued due to an adverse event were summarized by race.|Week 48|||Participants|||Number
777491|NCT00764946|Primary|Number of Participants With One or More Adverse Events|Numbers of participants with one or more adverse events were summarized by race.|Week 48|||Participants|||Number
777492|NCT00764946|Secondary|Number of Participants Without Loss of Virologic Response|For participants with confirmed HIV RNA levels <50 copies/mL on 2 consecutive visits, loss of virologic response is the occurrence of the first value >50 copies/mL or loss to follow-up; participants who never achieved HIV RNA <50 copies/mL on 2 consecutive visits are also considered as having loss of virologic response. Events are the numbers of participants with loss of virologic response versus the numbers of participants with no loss of virologic response (event free).|Week 48|Efficacy analyses were based on the Full Analysis Set population that included all participants who took at least one dose of study medication and had at least one postbaseline evaluation.||participants|||Number
777493|NCT00764946|Secondary|Mean Change From Baseline to Week 48 in CD4 Cell Count|Mean changes from baseline in CD4 cell counts were summarized by race at each time point.|Baseline and Week 48|"Efficacy analyses were based on the Full Analysis Set population that included all participants who took at least one dose of study medication and had baseline and at least one postbaseline evaluation.
Baseline values were carried forward for participants who discontinued before Week 48 due to lack of efficacy."||cells/mm^3||95% Confidence Interval|Mean
777494|NCT00764946|Secondary|Mean Change From Baseline to Week 48 in HIV RNA|Mean changes from baseline in plasma HIV RNA were summarized by race at each time point.|Baseline and Week 48|"Efficacy analyses were based on the Full Analysis Set population that included all participants who took at least one dose of study medication and had baseline and at least one postbaseline evaluation.
Baseline values were carried forward for participants who discontinued before Week 48 due to lack of efficacy."||log10 copies/mL||95% Confidence Interval|Mean
777495|NCT00764946|Secondary|Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 48|Numbers of participants with HIV RNA copies <400 copies/mL were summarized by race for each time point.|Week 48|Efficacy analyses were based on the Full Analysis Set population that included all participants who took at least one dose of study medication and had at least one postbaseline evaluation. The Treatment-Related Discontinuation = Failure approach was used as the primary method for handling missing HIV RNA values.||Participants|||Number
777496|NCT00764946|Primary|Number of Participants Who Achieved HIV Ribonucleic Acid (RNA) <50 Copies/mL at Week 48|Numbers of participants with HIV RNA copies <50 copies/mL were summarized by race for each time point.|Week 48|"Efficacy analyses were based on the Full Analysis Set population that included all participants who took at least one dose of study medication and had at least one postbaseline evaluation.
The Treatment-Related Discontinuation = Failure approach was used as the primary method for handling missing HIV RNA values."||Participants|||Number
777497|NCT00765037|Primary|Survivorship of the Encore Reverse Shoulder Prosthesis|Number of subjects who completed all study visits through the 1 year visit.|1 year|||participants|||Number
777537|NCT00765102|Secondary|Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0–∞)|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞) of Romidepsin based on plasma samples.|Day 1 (cycle 1): 1 hour prior to romidepsin administration, 0.25, 0.5, 1, 2, 3, 4, 6, and 24 hours after initiation of romidepsin infusion|A subset of participants from the lead investigator's site had PK samples taken.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
777498|NCT00765063|Secondary|36-Item Short-Form Health Survey (SF-36) Score|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline and Week 24 (EOT) or ET|ITT population included all participants who were enrolled into the study. This was calculated only when more than half of the questions within dimension were answered. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.||Units on a scale||Standard Deviation|Mean
777499|NCT00765063|Secondary|11-point Likert Pain Scale|The 11 point Likert pain scale which used a 0 (no pain) to 10 (worst possible pain) point rating system was used to assess participant’s pain score. No distinction was made between neuropathy and inflammatory (nociceptive) pain.|Baseline and Week 24 (EOT) or ET|ITT population included all participants who were enrolled into the study.||Units on a scale||Standard Deviation|Mean
777500|NCT00765063|Secondary|Number of Participants With Major Cardiovascular Disease Events (MCVE)|MCVE were defined as death due to vascular cause; non-fatal myocardial infarction (MI) excluding procedure related to MI; coronary revascularization procedures not related to MIs; hospitalization for unstable angina or non-fatal stroke.|Baseline through Week 24 (EOT) or ET|The data was not analyzed as planned because the study enrollment was terminated before the planned number of randomized participants was obtained.||Participants|||Number
777501|NCT00765063|Secondary|Time to First Amputation||Baseline through Week 24 (EOT) or ET|The data was not analyzed as planned because the study enrollment was terminated before the planned number of randomized participants was obtained.||Months||95% Confidence Interval|Median
777502|NCT00765063|Secondary|Time to Intact Skin Healing|Median time (in months) taken to achieve intact skin healing which was defined as 100 percent reduction in ulcer surface area with full epithelialisation.|Baseline through Week 24 (EOT) or ET|The data was not analyzed as planned because the study enrollment was terminated before the planned number of randomized participants was obtained.||Months||95% Confidence Interval|Median
777503|NCT00765063|Secondary|Number of Participants Who Underwent Amputation|A major amputation was defined as above the ankle and was reported as below-the-knee and above-the-knee amputations. A minor amputation was defined as below the ankle amputation.|Baseline through Week 24 (EOT) or ET|ITT population included all participants who were enrolled into the study.||Participants|||Number
777504|NCT00765063|Secondary|Number of Participants With Improved Ulcer Healing|Improved ulcer healing was defined as greater than or equal to 50 percent reduction in ulcer surface area from baseline of the A6301083 study excluding intact skin healing. The ulcer area was measured in square mm by measuring the longest width and length of the ulcer after debridement. Ulcers were also documented by standardized photographs.|Baseline through Week 24 (EOT) or ET|ITT population included all participants who were enrolled into the study.||Participants|||Number
777505|NCT00765063|Secondary|Number of Participants With Intact Skin Healing|Intact skin healing was defined as 100 percent reduction in ulcer surface area with full epithelialisation. The ulcer area was measured in square millimetre (mm) by measuring the longest width and length of the ulcer after debridement. The area was calculated from an acetate tracing. Ulcers were also documented by standardized photographs. The largest ulcer was considered the study ulcer in participants with multiple ulcers.|Baseline through Week 24 (EOT) or ET|Intent to treat (ITT) population included all participants who were enrolled into the study.||Participants|||Number
777506|NCT00765063|Primary|Number of Trivial Hemorrhages|Trivial bleeding was defined as all minor bleeding that did not meet the definition of clinically relevant minor bleeding.|Baseline to Week 24 (EOT) or ET|Safety analysis population included all participants who were known to have taken at least one dose of the study medication.||Hemorrhages|||Number
777507|NCT00765063|Primary|Number of Clinically Relevant Minor Hemorrhages|Clinically relevant minor (non-major) bleeding was defined as any bleeding compromising hemodynamics, leading to hospitalization, subcutaneous haematoma more than 25 cm^2, intramuscular haematoma, epistaxis lasting for more than 5 minutes, spontaneous gingival bleeding, macroscopic hematuria and gastrointestinal hemorrhage (including at least 1 episode of melaena or hematemesis), rectal blood loss, hemoptysis, and any other bleeding with clinical consequences.|Baseline to Week 24 (EOT) or ET|Safety analysis population included all participants who were known to have taken at least one dose of the study medication.||Hemorrhages|||Number
777508|NCT00765063|Primary|Number of Minor Hemorrhages|Minor hemorrhages: defined as bleeding that did not meet the definition of major bleeding.|Baseline to Week 24 (EOT) or ET|Safety analysis population included all participants who were known to have taken at least one dose of the study medication.||Hemorrhages|||Number
777509|NCT00765063|Primary|Number of Major Hemorrhages|Major hemorrhages: defined as fatal bleeding, clinically overt bleeding causing a fall in hemoglobin greater than or equal to 20 g/L (2 g/dL), clinically overt bleeding leading to transfusion of greater than or equal to 2 units of whole blood or red cells, or symptomatic bleeding in areas of special concern (intracranial, retroperitoneal, intraocular, intraspinal, pericardial, intramuscular with compartmental syndrome, or intraarticular).|Baseline to Week 24 (EOT) or ET|Safety analysis population included all participants who were known to have taken at least one dose of the study medication.||Hemorrhages|||Number
777510|NCT00765063|Primary|Number of All Hemorrhages|Major hemorrhages: defined as fatal bleeding, clinically overt bleeding causing a fall in hemoglobin greater than or equal to 20 gram (g)/litre (L) (2 g/ decilitre [dL]), clinically overt bleeding leading to transfusion of greater than or equal to 2 units of whole blood or red cells, or symptomatic bleeding in areas of special concern (intracranial, retroperitoneal, intraocular, intraspinal, pericardial, intramuscular with compartmental syndrome, or intraarticular). Minor hemorrhages: defined as bleeding that did not meet the definition of major bleeding.|Baseline to Week 24 (end of treatment [EOT]) or early termination (ET)|Safety analysis population included all participants who were known to have taken at least one dose of the study medication.||Hemorrhages|||Number
777538|NCT00765102|Secondary|Participants With Treatment-emergent Adverse Events (TEAEs)|Counts of participants with TEAEs, and subset by relation to drug, grade of severity, serious, TEAEs leading to discontinuation or leading to death. AEs were graded for severity according to the National Cancer Institute Common Terminology Criteria (NCI CTCAE), V 3.0: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe (prevents normal everyday activities); Grade 4: Life-threatening or disabling; Grade 5: Death.|up to 9 months|Safety population of participants who took at least one dose of drug.||participants|||Number
777511|NCT00765076|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom, regardless of intensity or relation to vaccination and related was event assessed by investigator as causally related to the study vaccination.|Day 0-364|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
777512|NCT00765076|Secondary|Number of Subjects Reporting Any AEs of Specific Interest (AESI)|AESI for safety monitoring are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Any was defined as occurrence of any symptom, regardless of intensity or relation to vaccination.|Day 0-364|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
777513|NCT00765076|Secondary|Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs)|For each solicited and unsolicited AE the subject experienced, the subject was asked if they received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom, regardless of intensity or relation to vaccination, grade 3 was defined as symptom that prevented normal activity and related was event assessed by investigator as causally related to the study vaccination.|Day 0-179|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
777514|NCT00765076|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom, regardless of intensity or relation to vaccination, grade 3 was unsolicited symptom that prevented normal activity and related was event assessed by investigator as causally related to the study vaccination.|Day 0-20|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
777515|NCT00765076|Secondary|Duration of Solicited General AEs|Duration was defined as number of days with any grade of general symptoms.|Day 0 -6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented on subjects who experienced the symptom.||Days||Full Range|Median
777516|NCT00765076|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs|Any fever was defined as oral temperature ≥ 38.0 degree centigrade (°C), grade 3 fever was defined as oral temperature ≥ 39.0°C. For other symptoms grade 3 was defined as general symptom that prevented normal activity and related was general symptom assessed by the investigator as causally related to the study vaccination.|Day 0 -6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
777517|NCT00765076|Secondary|Duration of Solicited Local AEs|Duration was defined as the number of days with any grade of local symptoms.|Day 0 -6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented on subjects who experienced the symptom.||Days||Full Range|Median
777518|NCT00765076|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)|Grade 3 ecchymosis, redness and swelling was >100mm and grade 3 pain was considerable pain at rest, that prevented normal everyday activity.|Day 0 -6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
777519|NCT00765076|Secondary|The Number of Subjects Seroprotected to HI Antibodies|A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.|At Day 0, 21, 42 and 180|The analysis was performed on According-to-Protocol (ATP) immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity data were available.||subjects|||Number
777520|NCT00765076|Secondary|HI Antibody Seroconversion Factors|Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0.|At Day 21, 42 and 180|The analysis was performed on According-to-Protocol (ATP) immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity data were available.||fold increase||95% Confidence Interval|Geometric Mean
777521|NCT00765076|Secondary|The Number of Subjects Seroconverted to HI Antibodies|Seroconversion was defined as the number of vaccinees who had either a prevaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.|At Day 21, 42 and 180|The analysis was performed on According-to-Protocol (ATP) immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity data were available.||subjects|||Number
777522|NCT00765076|Secondary|The Number of Subjects Seropositive to HI Antibodies Calculated After in Vitro Stimulation With Separate Vaccine Strains.|Seropositivity was defined as antibody titer greater than or equal to the cut-off value i.e ≥ 1:10|At Day 0, 21, 42 and 180|The analysis was performed on According-to-Protocol (ATP) immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity data were available.||subjects|||Number
777523|NCT00765076|Secondary|Haemagglutinin Inhibition (HI) Antibody Titers|Antibody titers were expressed as Geometric mean titers (GMTs) calculated after invitro stimulation with separate vaccine strains.|At Day 0, 21, 42 and 180|The analysis of immunogenicity was performed on According-to-Protocol (ATP) Immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity data were available.||titer||95% Confidence Interval|Geometric Mean
777524|NCT00765076|Secondary|The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker|The markers assessed were CD40L, IL-2, TNF-α, IFN-γ. The separate vaccine strains tested included A/Brisbane, A/Uruguay, B/Brisbane antigens.|At Day 0, 21, 42 and 180|The analysis was based on According-to-Protocol (ATP) Immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity data were available.||cells per million CD4+ Tcells||Standard Deviation|Geometric Mean
777525|NCT00765076|Secondary|The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Which Were Producing at Least Two Different Markers|The markers assessed were CD40L, IL-2, TNF-α, IFN-γ. The separate vaccine strains tested included A/Brisbane, A/Uruguay, B/Brisbane antigens.|At Day 0, 21, 42 and 180|Analysis was performed on According-to-Protocol (ATP) Immunogenicity cohort. This cohort included all evaluable subjects for whom data concerning immunogenicity were available.||cells per million CD4+ Tcells||Standard Deviation|Geometric Mean
777526|NCT00765076|Primary|The Geometric Mean (GM) Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains Which Are Producing at Least Two Different Markers|The markers assessed were Cluster of Differentiation 40 Ligand (CD40L), interleukin-2 (IL-2), tumor necrosis factor alpha (TNF-α), interferon-gamma (IFN-γ)|Day 21|Analysis was performed on According-to-Protocol (ATP) Immunogenicity cohort. This cohort included all evaluable subjects for whom data concerning immunogenicity were available. Analysis was only performed for New generation influenza vaccine GSK2186877A Group and Fluarix elderly Group.||cells per million CD4+ Tcells||Standard Deviation|Geometric Mean
777527|NCT00765102|Secondary|Kaplan Meier Estimates for Overall Survival|Overall survival is the time from initiation of therapy to death from any cause.|up to month 8|Intent to treat population. However efficacy data was not analyzed due to the early termination of the study.|||||
777528|NCT00765102|Secondary|Kaplan Meier Estimates for Progression-free Survival Assessed by the Investigator|"Progression-free survival is the time from initiation of therapy to progressive disease, removal from study for any reason, death from any cause, or the last follow-up visit, whichever occurs first.
Progressive Disease(PD):>25% increase in serum monoclonal paraprotein, or >25% plasma cells in marrow, or >25% increase in 24-hour urinary light chain excretion or increase in existing lytic bone lesions or soft tissue plasmacytomas or new bone lesions or soft tissue plasmacytomas, or hypercalcemia.
Disease progression for participants relapsing from a complete response: reappearance of serum or urinary paraprotein on imunofixation, >= 5% plasma cells in the bone marrow aspirate or biopsy, increase in existing lytic bone lesions or soft tissue plasmacytomas or new bone lesions or soft tissue plasmacytomas, development of hypercalcemia."|up to month 8|Intent to treat population. However efficacy data was not analyzed due to the early termination of the study.|||||
777529|NCT00765102|Secondary|Kaplan Meier Estimate for Duration of Response Assessed by the Investigator|"Duration of response is defined as the time from first response to progressive disease as assessed by the investigator.
Progressive Disease(PD):>25% increase in serum monoclonal paraprotein, or >25% plasma cells in marrow, or >25% increase in 24-hour urinary light chain excretion or increase in existing lytic bone lesions or soft tissue plasmacytomas or new bone lesions or soft tissue plasmacytomas, or hypercalcemia.
Disease progression for participants relapsing from a complete response: reappearance of serum or urinary paraprotein on imunofixation, >= 5% plasma cells in the bone marrow aspirate or biopsy, increase in existing lytic bone lesions or soft tissue plasmacytomas or new bone lesions or soft tissue plasmacytomas, development of hypercalcemia."|up to month 8|Intent to treat population. However efficacy data was not analyzed due to the early termination of the study.|||||
777530|NCT00765102|Secondary|Kaplan Meier Estimate for Time to Response Assessed by the Investigator|"The time to the first response is defined as the time from the initiation of therapy to the first evidence of a confirmed response (complete response, very good partial response, partial response or minimal response).
Complete Response: disappearance of monoclonal protein from blood and urine, and disappearance of soft tissue plasmacytomas, <5% plasmas cells in marrow and no increase of lytic bone lesions.
Very Good Partial Response: disappearance of plasmacytomas, no increase of lytic bone lesions, serum and urine M-protein not detectable by immunofixation, other.
Partial Response: >=50% decrease in serum monoclonal protein, and in soft tissue plasmacytomas, no increase of lytic bone lesions, other.
Minimal Response (MR): ≥ 25% to ≤ 49% decrease in serum monoclonal protein, and in size of plasmacytomas, no increase of lytic bone lesions, other."|up to month 8|Intent to treat population. However efficacy data was not analyzed due to the early termination of the study.|||||
777531|NCT00765102|Secondary|Kaplan Meier Estimate for Time to Progression Assessed by the Investigator|"Time to progression of disease is defined as the time from initiation of therapy to progressive disease as assessed by the investigator.
Progressive Disease(PD):>25% increase in serum monoclonal paraprotein, or >25% plasma cells in marrow, or >25% increase in 24-hour urinary light chain excretion or increase in existing lytic bone lesions or soft tissue plasmacytomas or new bone lesions or soft tissue plasmacytomas, or hypercalcemia.
Disease progression for participants relapsing from a complete response: reappearance of serum or urinary paraprotein on imunofixation, >= 5% plasma cells in the bone marrow aspirate or biopsy, increase in existing lytic bone lesions or soft tissue plasmacytomas or new bone lesions or soft tissue plasmacytomas, development of hypercalcemia."|up to month 8|Intent to treat population. Analysis was not performed due to early termination of the study.|||||
777532|NCT00765102|Secondary|Total Volume of Distribution (Vz)|Total volume of distribution of Romidepsin|Day 1 (cycle 1): 1 hour prior to romidepsin administration, 0.25, 0.5, 1, 2, 3, 4, 6, and 24 hours after initiation of romidepsin infusion|A subset of participants from the lead investigator's site had PK samples taken.||L||Geometric Coefficient of Variation|Geometric Mean
777533|NCT00765102|Secondary|Total Clearance (CL)|Total clearance of Romidepsin|Day 1 (cycle 1): 1 hour prior to romidepsin administration, 0.25, 0.5, 1, 2, 3, 4, 6, and 24 hours after initiation of romidepsin infusion|A subset of participants from the lead investigator's site had PK samples taken.||L/hr||Geometric Coefficient of Variation|Geometric Mean
777534|NCT00765102|Secondary|Terminal Half-life (t1/2)|Terminal half-life of Romidepsin|Day 1 (cycle 1): 1 hour prior to romidepsin administration, 0.25, 0.5, 1, 2, 3, 4, 6, and 24 hours after initiation of romidepsin infusion|A subset of participants from the lead investigator's site had PK samples taken.||hr||Geometric Coefficient of Variation|Geometric Mean
777535|NCT00765102|Secondary|Time to Maximum Observed Concentration (Tmax)|Time to maximum observed concentration of Romidepsin|Day 1 (cycle 1): 1 hour prior to romidepsin administration, 0.25, 0.5, 1, 2, 3, 4, 6, and 24 hours after initiation of romidepsin infusion|A subset of participants from the lead investigator's site had PK samples taken.||hr||Full Range|Median
777536|NCT00765102|Secondary|Maximum Observed Concentration (Cmax)|Maximum observed concentration of Romidepsin|Day 1 (cycle 1): 1 hour prior to romidepsin administration, 0.25, 0.5, 1, 2, 3, 4, 6, and 24 hours after initiation of romidepsin infusion|A subset of participants from the lead investigator's site had PK samples taken.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
777539|NCT00765102|Primary|Count of Participant Best Overall Response As Assessed by the Investigator|"Complete Response: disappearance of monoclonal protein from blood and urine, and disappearance of soft tissue plasmacytomas, <5% plasmas cells in marrow and no increase of lytic bone lesions.
Very Good Partial Response: disappearance of plasmacytomas, no increase of lytic bone lesions, serum and urine M-protein not detectable by immunofixation, other.
Partial Response: >=50% decrease in serum monoclonal protein, and in soft tissue plasmacytomas, no increase of lytic bone lesions, other.
Minimal Response (MR): ≥ 25% to ≤ 49% decrease in serum monoclonal protein, and in size of plasmacytomas, no increase of lytic bone lesions, other.
Stable Disease: Less than MR, but not PD
Progressive Disease(PD):>25% increase in serum monoclonal paraprotein, or >25% plasma cells in marrow, or >25% increase in 24-hour urinary light chain excretion or increase in existing lytic bone lesions or soft tissue plasmacytomas or new bone lesions or soft tissue plasmacytomas, or hypercalcemia."|up to 8 months|Intent-to-Treat (ITT) population of patients defined as all patients who receive at least one dose of romidepsin and bortezomib. However efficacy data was not analyzed due to the early termination of the study.|||||
777540|NCT00765128|Primary|Morphine Equivalents of Concomitant Pain Medication|The morphine equivalent is a unit of measure to compare the efficacy of different types of opioids (narcotics). The patients were allowed to take additional pain medication in addition to either study drug or placebo. This outcome measure reports the amount of morphine (in mg) equivalent to the amount of concomitant pain medication used by the patient.|24 hours after the end of surgery|||mg||Standard Deviation|Mean
777541|NCT00765128|Primary|Pain 'Right Now'|Visual analog scale score for pain on a scale from 0 = None to 10 = Worst.|24 hours after the end of surgery|||units on a scale||Standard Deviation|Mean
777542|NCT00765193|Secondary|Whether a Systematic Screening is Related to a Higher Number of Unnecessary Excisions of Benign Skin Tumors Detected During the Screening.||one year||||||
777543|NCT00765193|Primary|Number of Participants With Suspicious Tumors Detected After Inspection of Problem Area and Inspection of the Full Body.||one year|From a population of patients with various skin conditions, participants were considered for inclusion only if aged 18 years or more, and if suffering from focused skin complaints. Patients with diffuse skin complaints were excluded.||participants|||Number
777544|NCT00765206|Primary|Change From Baseline in Median 24-hour Intragastric pH on the 7th Day of Drug Administration|The change from Baseline in median pH was calculated as: median pH on Day 7 minus median pH at Baseline. The pH scale ranges from 0 to 14. A pH of 7 is neutral. A pH less than 7 is acidic. A pH greater than 7 is basic.|Baseline and 7 days|||pH scale||Full Range|Median
777545|NCT00765232|Primary|Morphine Equivalents of Concomitant Pain Medication|The morphine equivalent is a unit of measure to compare the efficacy of different types of opioids (narcotics). The patients were allowed to take additional pain medication in addition to either study drug or placebo. This outcome measure reports the amount of morphine (in mg) equivalent to the amount of concomitant pain medication used by the patient.|24 hours after the end of surgery|||mg||Standard Deviation|Mean
777546|NCT00765232|Primary|Pain 'Right Now'|Visual analog scale score for pain on a scale from 0 = None to 10 = Worst.|24 hours after the end of surgery|||units on a scale||Standard Deviation|Mean
777547|NCT00765245|Other Pre-specified|Exploratory: Concordance Between IHC for GCB and Non-GCB Subtypes to the Gene Expression Profiles Associated With the Subtypes||up to two years||||||
777548|NCT00765245|Other Pre-specified|Investigate Potential Predictive Biomarkers of Clinical Response or Resistance to Lenalidomide||up to two years||||||
777549|NCT00765245|Secondary|Number of Patients With Each Worst‐Grade Toxicity|Count of patients according to the worst‐grade toxicity experienced by each, where worst‐grade toxicity is per NCI common toxicity criteria: grade 1, mild; grade 2, moderate; grade 3, severe; grade 4, life‐threatening; grade 5, death. Toxicities present at baseline and continuing without change in grade are excluded when considering worst‐grade toxicity.|30 days after completing treatment, for up to 13 months|Total number of patients reported with any toxicity||participants|||Number
777550|NCT00765245|Secondary|Disease-free Survival at 2 Years|Disease-free survival is the estimated probable duration of life from on‐study date to date of death from any cause, using the Kaplan‐Meier method where death is an event, with censoring for non‐expired patients at last known date alive.|From on-treatment date to disease recurrence, up to 2 years|||years||95% Confidence Interval|Median
777551|NCT00765245|Primary|Disease-free Survival at 1 Year|Disease-free survival is the time from on-treatment to first relapse or death (whichever comes first). Those who are alive and without relapse are censored at the last date known alive.|From on-treatment date to disease recurrence, up to 1 year|||years||95% Confidence Interval|Mean
777552|NCT00765336|Primary|Mean Percent Change From Screening in Sperm Concentration.||Baseline and 12 Weeks|The enrollment was designed to ensure study completion of approximately 150 subjects. Actual enrollment was 180 subjects (92 in the minocycline group, 88 in the placebo group). A total of 145 subjects (72 in the minocycline group, 73 in the placebo group) comprised the completed population group.||Percent change||Standard Deviation|Mean
777553|NCT00765362|Primary|Knee Society Scores Used as Success/Failure Criteria.|The maximum score for each of the sections is 100 points. A score of at least 80 points on the 2-year knee assessment score was defined as a success.|2 year|Out of the 282 subjects who completed the study, only 173 were analyzed due to either the 2 year visit being completed out of window or missing data.||Percentage of Participants with Success|||Number
777554|NCT00765362|Primary|Knee Society Function Score|The patient function score considers only walking distance and stair climbing, with deductions for walking aids. The maximum function score is obtained by a patient who can walk an unlimited distance and go up and down stairs normally. Walking ability is expressed in blocks (approximately 100 meters). Stair climbing is considered normal if the patient can ascend and descend stairs without holding a railing. A score of > or = to 60 on the function score is considered success. Minimum score = 0, maximum score = 100 with the higher the score representing a better outcome.|2 year|Out of the 282 subjects who completed the study, only 173 were analyzed due to either the 2 year visit being completed out of window or missing data.||Average Knee Function Score||Standard Deviation|Mean
777610|NCT00765843|Primary|Heel Pain|Overall foot pain as determined by the Foot Function Index-Revised (FFI-R) survey. Foot pain is assessed by answering 11 questions regarding foot pain experienced over the past week. Scores may range from 11 to 66. Higher scores are indicative of greater foot pain.|baseline, one month and three months|||score on a survey||Standard Deviation|Mean
777555|NCT00765362|Primary|Knee Society Score Evaluation|The Knee Society Score includes a knee rating and function score. This evaluation covers the knee rating score with three main parameters of pain, stability and range of motion and that flexion contracture, extension lag and misalignment should be dealt with as deductions. Thus, 100 points will be obtained by a well-aligned knee with no pain, 125 degrees of motion, and negligible anteroposterior and mediolateral instability. 50 points are allotted for pain, 25 for stability, and 25 for range of motion. Grading for KS Score: Excellent (90-100), Good (80-90), Fair (70-79) and Poor (<70).|2 year|Out of the 282 subjects who completed the study, only 173 were analyzed due to either the 2 year visit being completed out of window or missing data.||Average Knee Rating Score||Standard Deviation|Mean
777556|NCT00765375|Primary|Change in Mean Lesion Count From Baseline at 90 Days|To determine the safety and efficacy of Botox Treatment in subjects with mild to moderate acne vulgaris defined by the Investigator's Global Assessment (IGA)|90 days|All subjects completing Day 90 visit||Lesions||Standard Deviation|Mean
777557|NCT00765388|Secondary|Changes in Skin Compared to Before Study|The patient was asked whether he/she experienced changes in the skin condition after testing the blue/red product|4 weeks|ITT population||Participants|||Number
777558|NCT00765388|Secondary|Bag Twisting During Night|The patient was asked if he/she noticed whether the bag twisted during night|4 weeks|ITT population||Participants|||Number
777559|NCT00765388|Secondary|Problems With Splashing Sounds During Use|The patient was asked whether he/she noticed any splashinh sounds during use|4 weeks|ITT population||Participants|||Number
777560|NCT00765388|Secondary|Feeling of Security During the Night|The patients feeling of security with the product during the night|4 weeks|ITT population||Participants|||Number
777561|NCT00765388|Secondary|Feeling of Security During the Day|The patients feeling of security with the bag during the day|4 weeks|ITT population||Participants|||Number
777562|NCT00765388|Secondary|Awareness of the Presence of the Product|Evaluates the patients awareness of the presence of the product during use.|4 weeks|ITT population||Participants|||Number
777563|NCT00765388|Secondary|Flexibility of the Product|Evaluation of the ability of the bag to conform with the patients movements (flexibility)|4 weeks|ITT population||Participants|||Number
777564|NCT00765388|Secondary|Adhesives Ability to Absorb Perspiration|Evaluation of the adhesives ability to absorb perspiration from the skin|4 weeks|ITT population||Participants|||Number
777565|NCT00765388|Secondary|Adhesion of the Bag During Use|Evaluation of the adhesion of the base plate around the stoma during use|4 weeks|ITT population||Participants|||Number
777566|NCT00765388|Secondary|Removal of the Bag|How easy/difficult it was to remove the bag|4 weeks|ITT population||Participants|||Number
777567|NCT00765388|Secondary|Immediate Adhesion|Evaluation of immediate adhesion after each period|4 weeks|Intention to treat (ITT)||Participants|||Number
777568|NCT00765388|Primary|Preference of Sensura vs Moderma|Subjects were asked which of the tested products they preferred; SenSura or Moderma.|4 weeks|||percentage of prefering the product|||Number
777569|NCT00765570|Secondary|Objective Response of Bulky Tumors of the Head and Neck Area, Lung, Abdomen or Pelvis to Standard Fractionated Radiation Therapy Plus Grid Therapy Compared to Standard Fractionated Radiation Therapy Alone.|Complete response (CR) = 100% tumor disappearance Partial response (PR) = > 50% reduction in size Stable disease (SD) = < 50% reduction or no change +/- 10% increase in tumor size Progressive disease (PD) = > 10% increase in size of tumor Unknown Status (UK)|during duration of treatment of 3 weeks. Follow up exams every 6 months for the next two years and then yearly for the rest of your life.|||participants|||Number
777570|NCT00765570|Primary|Protocol Treatment Related Morbidity|Number of grade 3 or higher complications during the assesment period. This does not include any complication felt to be due solely to malignancy|during duration of treatment of 3 weeks. Follow up exams every 6 months for the next two years and then yearly for the rest of your life.|||events|||Number
777571|NCT00765648|Secondary|Transition Time to Oral Medication|The median transition time (in hours) to oral medication|6 hours|these are the correct participant numbers for this secondary analysis||hours||Inter-Quartile Range|Median
777572|NCT00765648|Secondary|Subjects Requiring the Use of Intravenous Rescue Medications|The percent of subjects requiring the use of intravenous rescue medications|6 hours|||percentage of participants|||Number
777573|NCT00765648|Secondary|Treatment Failure|Treatment failure is defined as admission to the hospital or observation unit for BP management|6 hours|these are the correct participant numbers for this secondary analysis||percentage of participants|||Number
777574|NCT00765648|Secondary|Emergency Department(ED)Time to Disposition Decision|Median number of hours from hospital admission until Emergency Department(ED)disposition|6 hours|these are the correct participant numbers for this secondary analysis||hours||Inter-Quartile Range|Median
777575|NCT00765648|Secondary|Average Number of Dose Titrations Within 30 Minutes|Calculated as the mean (± standard deviation) number of titrations over 30 minutes for each treatment group|30 minutes|||number of titrations||Standard Deviation|Mean
777576|NCT00765648|Primary|Percentage of Subjects Achieving a Pre-defined Target Systolic Blood Pressure (BP) Within 30 Minutes.|Percentage of subjects achieving a pre-defined target systolic blood pressure (BP) range defined as a systolic blood pressure that is within +/- 20 mmHg of the target as established by the investigator.|30 minutes after initiation of therapy|Intent to treat cohort.||percentage of participants|||Number
777577|NCT00765661|Secondary|Evaluation of Safety and Efficacy of LCP-Tacro Compared to Prograf in Adult de Novo Kidney Transplant Patients.|"To evaluate the efficacy and safety of LCP-Tacro compared to Prograf in the first 12 months after kidney transplantation.
Efficacy was assessed by monitoring biopsy-proven acute rejection (BPAR) according to the Banff criteria, graft failure (defined by a patient starting dialysis for at least 30 days, nephrectomy, retransplantation, or death with a functioning graft), patient survival, and renal function based on serum creatinine and glomerular filtration rate (GFR), based on serum creatinine, serum urea nitrogen, and serum albumin."|12 months|All patients receiving at least one dose of study drug was included in the safety evaluation.||participants|||Number
777578|NCT00765661|Secondary|Comparative Pharmacokinetics Between LCP-Tacro and Prograf Within 14 Days After Kidney Transplantation.|To compare the pharmacokinetics (AUC, Cmax, C24/Cmin) on Days 1, 7 and 14 of LCP-Tacro with the pharmacokinetics of Prograf in adult de novo kidney transplant patients.|14 days|The outcome measure is listed as arithmetic mean of the pharmacokinetic parameters for raw data (not dose corrected) for tacrolimus in the ITT population on Day 14.||ng*hr/mL||Standard Deviation|Mean
777579|NCT00765661|Secondary|Comparative Pharmacokinetics Between LCP-Tacro and Prograf Within 14 Days After Kidney Transplantation.|To compare the pharmacokinetics (AUC, Cmax, C24/Cmin) on Days 1, 7 and 14 of LCP-Tacro with the pharmacokinetics of Prograf in adult de novo kidney transplant patients.|14 days|The outcome measure is listed as arithmetic mean of the pharmacokinetic parameters for raw data (not dose corrected) for tacrolimus in the ITT population on Day 14.||ng/mL||Standard Deviation|Mean
777580|NCT00765661|Primary|Pharmacokinetics of LCP-Tacro™ Tablets in the First 14 Days After Transplantation in Adult de Novo Kidney Recipients.|Comparison of the proportion of patients achieving sufficient tacrolimus whole blood trough levels (7 to 20 ng/mL) during the first 14 days post-transplantation|14 days|||percentage of patients|||Number
777581|NCT00765674|Secondary|Change in Mean 24-hour Ambulatory Systolic and Diastolic Blood Pressure From Baseline to End of Study (Week 8)|Twenty-four hour ambulatory blood pressure monitoring (ABPM) was performed in a subset of patients twice during the study, once at baseline and again at Week 8. The ABPM device was placed on the non-dominant arm between 7:00 and 10:00 am and verification readings obtained. If they were successful, the investigator initiated the 24 hour reading and instructed the patient regarding ABPM procedures. On the next day, the ABPM device was removed if it had been worn for a minimum of 24 hours. The ABPM data were downloaded and evaluated on site.|Baseline to end of study (Week 8)|Full analysis set population: All randomized patients who had post-baseline efficacy measurements.||mmHg||Standard Error|Least Squares Mean
777582|NCT00765674|Secondary|Percentage of Patients Achieving Blood Pressure Control at the End of the Study (Week 8)|Blood pressure control was defined as a msSBP/msDBP < 140/90 mmHg at the end of the study (Week 8). Blood pressure (BP) was measured at trough (24±3 hours post-dose). The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position with the back supported and both feet placed on the floor for 5 minutes, systolic and diastolic BP were measured 3 times with an automated BP monitor and appropriate size cuff. Means of the 3 measurements were calculated.|End of study (Week 8)|Full analysis set population: All randomized patients who had post-baseline efficacy measurements.||Percentage of patients|||Number
777583|NCT00765674|Secondary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8)|Blood pressure (BP) was measured at trough (24±3 hours post-dose). The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. If there was < 0.5 mmHg difference in BP between the 2 arms, the non-dominant arm was used. At each visit, after the patient was in a sitting position with the back supported and both feet placed on the floor for 5 minutes, systolic and diastolic BP were measured 3 times with an automated BP monitor and appropriate size cuff. Means of the 3 measurements were calculated. A negative change indicates lowered BP.|Baseline to end of study (Week 8)|Full analysis set population: All randomized patients who had post-baseline efficacy measurements.||mmHg||Standard Error|Least Squares Mean
777584|NCT00765674|Primary|Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8)|Blood pressure (BP) was measured at trough (24±3 hours post-dose). The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. If there was < 0.5 mmHg difference in BP between the 2 arms, the non-dominant arm was used. At each visit, after the patient was in a sitting position with the back supported and both feet placed on the floor for 5 minutes, systolic and diastolic BP were measured 3 times with an automated BP monitor and appropriate size cuff. Means of the 3 measurements were calculated. A negative change indicates lowered BP.|Baseline to end of study (Week 8)|Full analysis set population: All randomized patients who had post-baseline efficacy measurements.||mmHg||Standard Error|Least Squares Mean
777585|NCT00765726|Primary|Percentage of Participants With Factor VIII (FVIII) Inhibitor Development|FVIII inhibitor development was defined as an inhibitor titer of more than or equal to 0.6 Bethesda Units (BU) using the Nijmegen modification of the Bethesda assay and confirmed by the central laboratory.|Month 24 or early withdrawal|Safety analysis population included all enrolled participants who had taken at least 1 dose of the study medication.||Percentage of participants||95% Confidence Interval|Number
777586|NCT00765765|Primary|Tumor Response Rate|Overall Complete Response and Partial Response will be considered tumor response. Ixabepilone as a single agent (40 mg/m2 as an intravenous infusion every 3 weeks) was evaluated in a previous (Phase II) study in women with metastatic breast cancer and that the objective tumor response rate was 11.5%. In another(Phase III) study, Ixabepilone in combination with capecitabine resulted in an objective tumor response rate of 35%, compared to that of capecitabine alone (14%). Therefore, in the Phase II portion of the ixabepilone plus hydroxychloroquine combination treatment study, a tumor response rate of less than 15% will be deemed uninteresting. The target tumor response rate will be 35%. Due to uncertainty about the true response rate of ixabepilone plus hydroxychloroquine combination on this patient poupation, we also will consider a response rate of 30% to be encouraging.|3 years|The study was closed early due to slow accrual. Insufficient data were collected to evaluate this outcome measure.|||||
777587|NCT00765765|Secondary|Correlation of Estrogen Receptor, Progesterone Receptor and/or HER2 Status With Treatment Response||5 years|The study was closed early due to slow accrual. Insufficient data were collected to analyze this outcome measure.|||||
777588|NCT00765765|Secondary|Effects of Hydroxychloroquine on Autophagy||2 years|The study was closed early due to slow accrual. Insufficient data were collected to analyze this outcome measure.|||||
777589|NCT00765765|Secondary|Pharmacodynamic Markers for Autophagy Detection||2 years|The study was closed early due to slow accrual. Insufficient data were collected to analyze this outcome measure.|||||
777590|NCT00765765|Secondary|Survival Time||5 years|The study was closed early due to slow accrual. Insufficient data were collected to analyze this outcome measure.|||||
777591|NCT00765765|Secondary|Time to Progressive Disease||5 years|The study was closed early due to slow accrual. Insufficient data were collected to analyze this outcome measure.|||||
777592|NCT00765765|Secondary|Duration of Response||5 years|The study was closed early due to slow accrual. Insufficient data were collected to analyze this outcome measure.|||||
777593|NCT00765817|Secondary|Percentage of Subjects Experiencing Minor Hypoglycemia|Percentage of subjects in each arm experiencing at least one episode of minor hypoglycemia at any point during the study. Minor hypoglycemia was defined as any time a subject felt he or she was experiencing a sign or symptom associated with hypoglycemia that was either self-treated by the subject or resolved on its own and had a concurrent finger stick blood glucose <3.0 mmol/L (54 mg/dL).|baseline and weeks 2, 4, 6, 8, 10, 14, 18, 22, 26, and 30|Full analysis set||percentage|||Number
777594|NCT00765817|Secondary|Minor Hypoglycemia Rate Per Year|Number of minor hypoglycemia events experienced per subject per year. Minor hypoglycemia was defined as any time a subject felt he or she was experiencing a sign or symptom associated with hypoglycemia that was either self-treated by the subject or resolved on its own and had a concurrent finger stick blood glucose <3.0 mmol/L (54 mg/dL).|baseline and weeks 2, 4, 6, 8, 10, 14, 18, 22, 26, and 30|Full analysis set||events per subject per year||Standard Deviation|Mean
777595|NCT00765817|Secondary|Change in Diastolic Blood Pressure (DBP)|Change in DBP following 30 weeks of therapy (i.e., DBP at week 30 minus DBP at baseline)|baseline and 30 weeks|Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis||mmHg||Standard Error|Least Squares Mean
777596|NCT00765817|Secondary|Change in Systolic Blood Pressure (SBP)|Change in SBP following 30 weeks of therapy (i.e., SBP at week 30 minus SBP at baseline)|baseline and 30 weeks|Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis||mmHg||Standard Error|Least Squares Mean
777597|NCT00765817|Secondary|Change in Daily Insulin Dose (on a Per Body Weight Basis)|Change in daily insulin dose per kilogram (kg) following 30 weeks of therapy (i.e., daily insulin dose per kg at week 30 minus daily insulin dose per kg at baseline)|baseline and 30 weeks|Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis||insulin units per kg (U/kg)||Standard Error|Least Squares Mean
777598|NCT00765817|Secondary|Change in Daily Insulin Dose|Change in daily insulin dose following 30 weeks of therapy (i.e., daily insulin dose at week 30 minus daily insulin dose at baseline)|baseline and 30 weeks|Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis||insulin units (U)||Standard Error|Least Squares Mean
777599|NCT00765817|Secondary|Change in Waist Circumference|Change in waist circumference following 30 weeks of therapy (i.e., waist circumference at week 30 minus waist circumference at baseline)|baseline and 30 weeks|Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis||cm||Standard Error|Least Squares Mean
777600|NCT00765817|Secondary|Change in Body Weight|Change in body weight following 30 weeks of therapy (i.e., body weight at week 30 minus body weight at baseline)|baseline and 30 weeks|Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis||kg||Standard Error|Least Squares Mean
777601|NCT00765817|Secondary|Change in Triglycerides|Change in triglycerides following 30 weeks of therapy (i.e., triglycerides at week 30 minus triglycerides at baseline)|baseline and 30 weeks|Full analysis set. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis||mmol/L||Standard Error|Least Squares Mean
777602|NCT00765817|Secondary|Change in High Density Lipoprotein (HDL) Cholesterol|Change in HDL cholesterol following 30 weeks of therapy (i.e., HDL cholesterol at week 30 minus HDL cholesterol at baseline)|baseline and 30 weeks|Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.||mmol/L||Standard Error|Least Squares Mean
777603|NCT00765817|Secondary|Change in Low Density Lipoprotein (LDL) Cholesterol|Change in LDL cholesterol following 30 weeks of therapy (i.e., LDL cholesterol at week 30 minus LDL cholesterol at baseline)|baseline and 30 weeks|Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis||mmol/L||Standard Error|Least Squares Mean
777604|NCT00765817|Secondary|Change in Total Cholesterol|Change in total cholesterol following 30 weeks of therapy (i.e., total cholesterol at week 30 minus total cholesterol at baseline)|baseline and 30 weeks|Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis||mmol/L||Standard Error|Least Squares Mean
777605|NCT00765817|Secondary|Change in 7-point Self-monitored Blood Glucose (SMBG) Profile|Change in 7-point (pre-breakfast, 2 hour post-breakfast, pre-lunch, 2 hour post-lunch, pre-dinner, 2 hour post-dinner, 0300 hours) SMBG profile from baseline to week 30 (change = blood glucose value at week 30 minus blood glucose value at baseline)|baseline and 30 weeks|Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis||mmol/L||Standard Error|Least Squares Mean
777606|NCT00765817|Secondary|Change in Fasting Serum Glucose|Change in fasting serum glucose following 30 weeks of therapy (i.e., fasting serum glucose at week 30 minus fasting serum glucose at baseline)|baseline and 30 weeks|Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis||mmol/L||Standard Error|Least Squares Mean
777607|NCT00765817|Secondary|Percentage of Patients Achieving HbA1c <=6.5%|Percentage of patients in each arm who had HbA1c >6.5% at baseline and had HbA1c <=6.5% at week 30 (percentage = [number of subjects with HbA1c <=6.5% at week 30 divided by number of subjects with HbA1c >6.5% at baseline] * 100%).|baseline and 30 weeks|Full analysis set. Last observation carried forward. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. Only patients with baseline HbA1c > target were included in calculation.||percentage|||Number
777608|NCT00765817|Secondary|Percentage of Patients Achieving HbA1c <=7%|Percentage of patients in each arm who had HbA1c >7% at baseline and had HbA1c <=7% at week 30 (percentage = [number of subjects with HbA1c <=7% at week 30 divided by number of subjects with HbA1c >7% at baseline] * 100%).|baseline and 30 weeks|Full analysis set. Last observation carried forward. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. Only patients with baseline HbA1c > target were included in calculation.||percentage|||Number
777609|NCT00765817|Primary|Change in Glycosylated Hemoglobin (HbA1c)|Change in HbA1c from baseline following 30 weeks of therapy (i.e., HbA1c at week 30 minus HbA1c at baseline). Unit of measure is percent of hemoglobin that is glycosylated.|baseline and 30 weeks|Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis||percentage of hemoglobin||Standard Error|Least Squares Mean
777611|NCT00765882|Secondary|12-Week Constipation Severity|Constipation severity was based on a 5-point ordinal scale where a value of l is “none” and a value of 5 is “very severe”.|Change from Baseline to Week 12|A total of 633 patients were randomized to treatment and received at least 1 dose of study drug. 630 patients were included in the ITT population; 11 additional patients who dropped out prior to finishing 1 week of the trial were excluded from the Constipation Severity endpoint. An observed-cases approach to missing postbaseline data was applied.||units on a scale||Standard Error|Least Squares Mean
777612|NCT00765882|Secondary|12-Week Bloating|Bloating was based on a 5-point scale where a value of l is “none” and a value of 5 is “very severe”.|Change from Baseline to Week 12|A total of 633 patients were randomized to treatment and received at least 1 dose of study drug. 630 patients were included in the ITT population; 1 additional patient without a baseline Bloating score was excluded from analysis in this endpoint. An observed-cases approach to missing postbaseline data was applied.||units on a scale||Standard Error|Least Squares Mean
777613|NCT00765882|Secondary|12-Week Abdominal Discomfort|Abdominal discomfort is based on a 5-point scale where a value of l is “none” and a value of 5 is “very severe.”|Change from Baseline to Week 12|A total of 633 patients were randomized to treatment and received at least 1 dose of study drug. 630 patients were included in the Intent to Treat (ITT) Population. 1 additional patient without a baseline Abdominal Discomfort score was excluded from analysis in this endpoint. An observed-cases approach to missing postbaseline data was applied.||units on a scale||Standard Error|Least Squares Mean
777614|NCT00765882|Secondary|12-Week Severity of Straining|Straining is measured on a 5-point scale, where a value of 1 is “not at all” and a value of 5 is “an extreme amount.|Change from Baseline to Week 12|A total of 633 patients were randomized to treatment and received at least 1 dose of study drug. 630 patients were included in the ITT Population; 97 Patients with no pretreatment spontaneous bowel movements were excluded from the 12-Week Severity of Straining analysis. An observed-cases approach to missing postbaseline data was applied.||units on a scale||Standard Error|Least Squares Mean
777615|NCT00765882|Secondary|12-Week Stool Consistency|"The consistency of each BM was assessed using the 7-point Bristol Stool Form Scale:
= separate hard lumps like nuts [difficult to pass]
= sausage shaped but lumpy
= like a sausage but with cracks on surface
= like a sausage or snake, smooth and soft
= soft blobs with clear-cut edges [passed easily]
= fluffy pieces with ragged edges, a mushy stool
= watery, no solid pieces [entirely liquid]"|Change from Baseline to Week 12|A total of 633 patients were randomized to treatment and received at least 1 dose of study drug. 630 patients were included in the ITT Population; 97 patients with no pretreatment spontaneous bowel movements were excluded from the 12-Week Stool Consistency analysis. An observed-cases approach to missing postbaseline data was applied.||units on a scale||Standard Error|Least Squares Mean
777616|NCT00765882|Secondary|12-Week Spontaneous Bowel Movement (SBM) Frequency Rate|A patient’s 12-week spontaneous bowel movement (SBM) frequency rate was the number of SBMs per week calculated over the 12-weeks of the treatment period.|Change from Baseline to Week 12|A total of 633 patients were randomized to treatment and received at least 1 dose of study drug. 630 patients were included in the Intent to Treat (ITT) Population. An observed-cases approach to missing postbaseline data was applied.||SBM per week||Standard Error|Least Squares Mean
777617|NCT00765882|Secondary|12-week Complete Spontaneous Bowel Movement (CSBM) Frequency Rate|The number of CSBMs per week.|Change from Baseline to Week 12|A total of 633 patients were randomized to treatment and received at least 1 dose of study drug. 630 patients were included in the Intent to Treat (ITT) Population. An observed-cases approach to missing postbaseline data was applied.||CSBM per week||Standard Error|Least Squares Mean
777618|NCT00765882|Primary|Complete Spontaneous Bowel Movement (CSBM) Overall Responder|"A 12-week CSBM overall responders was defined as a patient who for at least 9 of the 12 weeks of the treatment period had a CSBM weekly frequency rate that was 3 or greater and increased by 1 or more from baseline.
A CSBM was defined as a spontaneous bowel movement (SBM) that was associated with a sense of complete evacuation.
An SBM was defined as a bowel movement (BM) that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM."|Change from Baseline to Week 12|A total of 633 patients were randomized to treatment and received at least 1 dose of study drug. 630 patients were included in the Intent to Treat (ITT) Population. An observed-cases approach to missing postbaseline data was applied.||participants|||Number
777619|NCT00765895|Primary|Decrease From the Baseline GCSI of at Least 50% on Any Two Consecutive Follow-up Visits|A decrease from the baseline Gastroparesis Cardinal Symptom Index (GCSI) score (sum of the 9 individual symptom scores) of at least 50% on any two consecutive follow-up visits during the 15 week treatment period with maximum tolerated study drug dose. The total score ranges from 0-45 with higher scores indicating greater symptom severity.|at end of treatment, 15 weeks from baseline assessment|intention to treat||participants||95% Confidence Interval|Number
777620|NCT00765947|Secondary|Overall Safety and Tolerability of Aliskiren Monotherapy and in Combination Treatment||24 weeks||||||
777621|NCT00765947|Secondary|Percent of Responders for Mean Sitting Systolic Blood Pressure [msSBP] and for Mean Sitting Diastolic Blood Pressure [msDBP]|Response for mean sitting Systolic Blood Pressure [msSBP] is defined as a reduction of ≥ 20 mmHg from baseline or mean sitting Systolic Blood Pressure [msSBP] < 140 mmHg (non diabetics) or < 130 mmHg (diabetics). Response for mean sitting Diastolic Blood Pressure [msDBP] is defined as a reduction of ≥10 mmHg from baseline or mean sitting Diastolic Blood Pressure [msDBP] < 90 mmHg (non diabetic) or < 80 mmHg (diabetics).|24 weeks|||Percentage of Participants|||Number
777622|NCT00765947|Secondary|Changes From Baseline to Week 24 in Mean Sitting Systolic Blood Pressure [msSBP] and Mean Sitting Diastolic Blood Pressure [msDBP]||Baseline and Week 24|Full analysis set||mm Hg||Standard Deviation|Mean
777623|NCT00765947|Secondary|Percentage of Patients (Defined as Estimated Cumulative Control Rate) Reaching Blood Pressure Target in a Stepped-care, Aliskiren-based Regimen by Patient Subgroups of Mild and Moderate Hypertensive Patients, and Non-diabetic and Diabetic Patients.|For non diabetic patients the Blood Pressure target is defined as mean sitting Systolic Blood Pressure [msSBP] < 140 mmHg and mean sitting Diastolic Blood Pressure [msDBP] < 90 mmHg and for diabetic patients the Blood Pressure target is mean sitting Systolic Blood Pressure [msSBP] < 130 mmHg and mean sitting Diastolic Blood Pressure [msDBP] < 80 mmHg.|24 weeks|||Percentage of Participants|||Number
779674|NCT00793546|Secondary|Maximum Observed Plasma Concentration (Cmax)||0 hour (pre-dose) on Day 1, 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 29|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.|||||
777624|NCT00765947|Primary|Percentage of Participants (Defined as Estimated Cumulative Control Rate) Reaching Blood Pressure Target in a Stepped Care, Aliskiren-based Regimen|For non diabetic patients the Blood Pressure target is defined as mean sitting Systolic Blood Pressure [msSBP] < 140 mmHg and mean sitting Diastolic Blood Pressure [msDBP] < 90 mmHg and for diabetic patients the Blood Pressure target is mean sitting Systolic Blood Pressure [msSBP] < 130 mmHg and mean sitting Diastolic Blood Pressure [msDBP] < 80 mmHg.|24 weeks|Full analysis set||Percentage of participants|||Number
777625|NCT00766051|Secondary|"A Priori H4: A Total Scale Score of Parents' Perception of Infant Easiness (Wolke, 1995) Was Measured on a Pre-post Test Scale."|The Easiness Scale measures the parent's perceived efficacy in the areas of infant irritability, sleeping habits, alertness and responsiveness, and difficulty. The Easiness Scale(Wolke [in Brazelton and Nugent], 1995]) was used to determine mother/parent perceptions of their infants' mood and state in the NICU as a result of training in NBOTI. An increasing score denotes an improvement in parent efficacy in their perception of their infant's easiness.uses a Likert scale. There are four questions, ranging from -3-3. The maximum score is 12, and the minimum score is -12.|Upon an infant's entry into the study, and again at discharge (at or less than 20 days).|The intervention group consisted of Three Preterm infants with high risk factors, Three term or near term infants with Gastroschisis, Two near term infants with Omphalocele, and One near term infant Congenital Diaphragmatic Hernia.||Scores on Scale||Standard Deviation|Mean
777626|NCT00766051|Secondary|"A Priori H3: A Total Score of the Parents' Global Confidence (Wolke, 1995) Was Measured on a Pre-post Test Scale."|The Global Confidence Scale of The Mother and Baby Scales (Wolke [in Brazelton and Nugent], 1995]) is a total score measure of mother/parent self efficacy in the NICU as a result of training in NBOTI. It is a total score measure of the parent's perceived efficacy of themselves as confidence in the feeding, handling, caretaking, and interactions needed to foster relationships with their infants. An increase in this score denotes an increase in the parent's perception of their global confidence in caring for their infant. Global Confidence Measure uses a Likert scale. There are three questions, ranging from -3-3. The maximum score is 9, and the minimum score is -9.|Upon an infant's entry into the study, and at discharge (at or less than 20 days).|The intervention group consisted of Three Preterm infants with high risk factors, Three term or near term infants with Gastroschisis, Two near term infants with Omphalocele, and One near term infant Congenital Diaphragmatic Hernia.||scores on scale||Standard Deviation|Mean
777627|NCT00766051|Secondary|A Priori H2: The Increase in Oral Feeding Percentage Over Days Was Correlated With Increasing Respiratory Competency During Oral Feeding; Measured as the High Frequency Percentage (HF%) of Intervention Groups' Heart Rate Variability (HRV) During Feeding.|Oral feeding percentage was based upon 150 kc/kg/day. Heart rate data was recorded about once per week during feeding using a Holter monitor connected to the bedside ecg. This data was downloaded in Cardiology, converted to numerical data as HRV by bioengineers at Politecnico di Milano, Italy. As infants reached 100% of oral feedings, heart rate variability data was analyzed to determine the infants' overall trend toward relaxation, measured as increasing High Frequency Percentage (HF %). Hierarchical linear modeling (HLM) (Singer and Willett, 2003) SPSS Grad Pack 17, mixed model analysis.|The time frame was from Baseline until discharge (at or before 20 days).|The intervention group consisted of Four Preterm infants with high risk factors, Three term or near term infants with Gastroschisis, and Two near term infants with Omphalocele. This outcome measured the correlation between the percentage of oral feedings and the percentage of High Frequesncy Heart Rate Variability.||Percentage||Standard Deviation|Mean
777628|NCT00766051|Primary|A Priori H1. The Number of Days to Achieve Oral Feeding Between the Intervention Group and the Matched Historical Comparison Group - From All Tube to All Oral Feeding - Was Analyzed.|This outcome measured the number of days it took to go from all tube to all oral feeding or at discharge, whichever came first. Oral feeding percentages were based upon 150 kcal/kg/day. Feeding volumes and weights were taken directly from the nurses notes, and averaged daily. A two sample t-test was used to detect differences between the groups.|The time frame was from Baseline until all oral feeding or discharge, whichever came first (at or before 35 days).|The intervention group and matched historical comparison group consisted of Four pairs of Extremely Preterm to Preterm infants with high risk factors, Three pairs of term or near term infants with Gastroschisis, Two pairs of infants term or near term with Omphalocele, and One pair of infants term age with Congenital Diaphragmatic Hernia.||Days||Standard Deviation|Mean
777629|NCT00766090|Secondary|Number of Participants Who Withdrew Due to Worsening of Asthma During the Three Treatment Periods|Participants were withdrawn from the study due to worsening of asthma (lack of efficacy) if they experienced a clinical asthma exacerbation or if clinic FEV1 fell below the FEV1 stability limit, or if during the 7 days immediately preceeding a visit the participant experienced either four or more days in which the PEF had fallen below the PEF stability limit or three or more days in which >=12 inhalations/day of albuterol/salbutamol were used. A clinical asthma exacerbation is defined as the worsening of asthma requiring emergency room visits, hospitalization, or treatment with an asthma medication (inhaled or systemic corticosteroids) other than study medication or rescue salbutamol/albuterol.|From the first dose of the study medication up to Week 16/Early Withdrawal|ITT Population||participants|||Number
777630|NCT00766090|Secondary|Heart Rate at Day 0 and Day 28 of the Relevant Treatment Period|Heart rate was measured at Day 0 (clinic visits 2, 4, and 6) and Day 28 (clinic visits 3, 5, and 7) of the relevant treatment period.|Day 0 and Day 28 of the relevant treatment period (up to Study Day 112)|ITT Population. Only those participants available at the specified time points were analyzed.||beats per minute||Standard Deviation|Mean
777631|NCT00766090|Secondary|Systolic and Diastolic Blood Pressure at Day 0 and Day 28 of the Relevant Treatment Period|Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured at Day 0 (clinic visits 2, 4, and 6) and Day 28 (clinic visits 3, 5, and 7) of the relevant treatment period.|Day 0 and Day 28 of the relevant treatment period (up to Study Day 112)|ITT Population. Only those participants available at the specified time points were analyzed.||millimeters of mercury (mmHg)||Standard Deviation|Mean
777632|NCT00766090|Secondary|Number of Participants With Evidence of Oropharyngeal Candidiasis at Day 0 and Day 28 of the Relevant Treatment Period|Detailed oropharyngeal examination for visual evidence of oropharyngeal candidiasis was performed at Day 0 (clinic visits 2, 4, and 6) and Day 28 (clinic visits 3, 5, and 7) of the relevant treatment period.|Day 0 and Day 28 of the relevant treatment period (up to Study Day 112)|ITT Population. Only those participants available at the specified time points were analyzed.||participants|||Number
777633|NCT00766090|Secondary|24-hour Urinary Cortisol Excretion at Day 28 of the Relevant Treatment Period|A 24-hour urine sample was collected, and the 24-hour urinary cortisol excretion was analyzed at Day 28 of the relevant treatment period.|Day 28 of the relevant treatment period (up to Study Day 112)|Urine Cortisol (UC) Population: participants who had both a Baseline urine sample and at least one urine sample from the end of a treatment period that did not have confounding factors that could affect the interpretation of results||Nanomoles per 24 hours||Geometric Coefficient of Variation|Geometric Mean
777634|NCT00766090|Secondary|Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Three 28-day Treatment Periods|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations. Refer to the general AE/SAE module for a list of AEs (occuring at a frequency threshold >=3%) and SAEs.|From the first dose of the study medication up to Week 16/Early Withdrawal|ITT Population||participants|||Number
777635|NCT00766090|Primary|Trough Forced Expiratory Volume in One Second (FEV1) at Day 28 of the Relevant Treatment Period|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured electronically by spirometry. Trough FEV1 was the evening pre-dose, pre-rescue bronchodilator FEV1 measurement taken on Day 28 of the relevant treatment period. The analysis was performed using mixed model analysis of covarience (ANCOVA) with fixed effects of treatment, period, sex, and age. Participants were fitted as a random effect, and the period Baseline measurement was included as part of a bivariate response.|Day 28 of the relevant treatment period (up to Study Day 112)|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study medication||Liters||Standard Error|Least Squares Mean
777636|NCT00766363|Secondary|Rivastigmine PK Data Following the First Dose of EVP-6124 - Area Under the Curve (AUC[0-24 h])|Rivastigmine PK data; Area Under the Curve (AUC[0-24 h]); i.e, area under the concentration-time plot for rivastigmine after dosing with EVP-6124|24 hours|PK Population: All safety population subjects who had sufficient plasma concentration data to facilitate calculation of PK parameters. Only 4 subjects took rivastigmine concomitantly.||h*ng/mL||Standard Deviation|Mean
777637|NCT00766363|Secondary|Rivastigmine PK Data Following the First Dose of EVP-6124 - Time to Maximum Concentration (Tmax)|Rivastigmine PK data; Time to Maximum Concentration (Tmax); i.e, amount of time required to reach highest concentration of rivastigmine in plasma after dosing with EVP-6124|24 hours|PK Population: All safety population subjects who had sufficient plasma concentration data to facilitate calculation of PK parameters. Only 4 subjects took rivastigmine concomitantly.||hours||Standard Deviation|Mean
777638|NCT00766363|Secondary|Rivastigmine PK Data Following the First Dose of EVP-6124 - Maximum Concentration (Cmax)|Rivastigmine PK data; Maximum Concentration (Cmax); i.e, highest concentration of rivastigmine in plasma after dosing with EVP-6124|24 hours|PK Population: All safety population subjects who had sufficient plasma concentration data to facilitate calculation of PK parameters. Only 4 subjects took rivastigmine concomitantly.||ng/mL||Standard Deviation|Mean
777639|NCT00766363|Secondary|Donepezil PK Data Following the First Dose of EVP-6124 – Area Under the Curve (AUC[0-24 h])|Donepezil PK data; Area Under the Curve (AUC[0-24 h]); i.e, area under the concentration-time plot for donepezil (parent compound only) after dosing with EVP-6124|24 hours|PK Population: All safety population subjects who had sufficient plasma concentration data to facilitate calculation of PK parameters.||h*ng/mL||Standard Deviation|Mean
777640|NCT00766363|Secondary|Donepezil PK Data Following the First Dose of EVP-6124 – Time to Maximum Concentration (Tmax)|Donepezil PK data; Time to Maximum Concentration (Tmax); i.e, amount of time required to reach highest concentration of donepezil (parent compound only) in plasma after dosing with EVP-6124|24 hours|PK Population: All safety population subjects who had sufficient plasma concentration data to facilitate calculation of PK parameters.||hours||Standard Deviation|Mean
777641|NCT00766363|Secondary|Donepezil PK Data Following the First Dose of EVP-6124 – Maximum Concentration (Cmax)|Donepezil PK data; Maximum Concentration (Cmax); i.e, highest concentration of donepezil (parent compound only) in plasma after dosing with EVP-6124|24 hours|PK Population: All safety population subjects who had sufficient plasma concentration data to facilitate calculation of PK parameters.||ng/mL||Standard Deviation|Mean
777642|NCT00766363|Secondary|EVP-6124 PK Data Following the First Dose of EVP-6124 – Area Under the Curve (AUC[0-24 h])|EVP-6124 PK data; Area Under the Curve (AUC[0-24 h]); i.e, area under the concentration-time plot|24 hours|PK Population: All safety population subjects who had sufficient plasma concentration data to facilitate calculation of PK parameters.||h*ng/mL||Standard Deviation|Mean
777643|NCT00766363|Secondary|EVP-6124 PK Data Following the First Dose of EVP-6124 – Time to Maximum Concentration (Tmax)|EVP-6124 PK data; Time to Maximum Concentration (Tmax); i.e, amount of time required to reach highest concentration of drug in plasma|24 hours|PK Population: All safety population subjects who had sufficient plasma concentration data to facilitate calculation of PK parameters.||hours||Standard Deviation|Mean
777644|NCT00766363|Secondary|EVP-6124 PK Data Following the First Dose of EVP-6124 – Maximum Concentration (Cmax)|EVP-6124 PK data; Maximum Concentration (Cmax); i.e, highest concentration of drug in plasma|24 hours|PK Population: All safety population subjects who had sufficient plasma concentration data to facilitate calculation of PK parameters.||ng/mL||Standard Deviation|Mean
777645|NCT00766363|Primary|Safety and Tolerability of Multiple Doses of EVP-6124 or Placebo in Subjects With Alzheimer’s Disease|All adverse experiences spontaneously reported by subject and/or observed by investigator and repeated clinical evaluation of physical examinations, vital signs, 12-lead ECG (electrocardiogram), ambulatory ECG, and laboratory tests (hematology/blood chemistry/urinalysis)|Pre-treatment (Day -2) [or screening for physical examination] to Day 28 [or Day 35, for AEs only]|Safety Population: All randomized subjects who ingested at least 1 dose of study drug.||Participants|||Number
778143|NCT00774163|Primary|Number of Participants With a Positive Blood Culture for L. Reuteri|To assess association between administration of Lactobacillus reuteri (Lr) strain DSM 17938 and abnormal lab values (CBC, BUN, Creatinine, AST, ALT, blood culture).|participants were followed for an average of 36 days|2:1 randomization Lactbacillus:placebo using a randomizatin table as specified in the protocol||participants|||Number
777646|NCT00766376|Secondary|Number of Participants That Have Reduction in Pigmented Lesions and Dyschromia.|To assess reductions in pigmented lesions and dyschromia, blinded evaluators were asked to assess pre-treatment and post-treatment photographs. The blinded evaluators were asked to grade percent improvement for pigmentation using a 0 to 10 scale (0=none and 10=severe) and the following quartile improvement scale: 1=1-24%, 2=25-49%, 3=50-74% and 4=75-100%. The blinded-evaluator scores were tabulated and analyzed in order to assess the effects.|participants at three months|||Participants|||Number
777647|NCT00766376|Primary|Number of Participants That Scored Above a One Category (Mild) Improvement Using the Fitzpatrick Wrinkle Scale.|To assess wrinkle improvement, 3 blinded evaluators use the validated Fitzpatrick Wrinkle Scale (FWS), a 0 to 9 (0=no wrinkles, 9=severe wrinkles) point scale to score the degree of wrinkles, fine lines, and the severity of skin elastosis. Evaluators assign a FWS score to pre-treatment and post-treatment photographs. The difference between the two scores is the amount (i.e., category) of wrinkle improvement. An improvement of one category means a mild improvement in wrinkle reduction.|participants at three months|||Participants|||Number
777648|NCT00772005|Secondary|Change From Baseline to Week 24 in Sleep Quality Rating|A sleep questionnaire was used to evaluate the effect of armodafinil on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 24 in participants' ratings of their quality of sleep as measured on a 4-point scale (1=Poor, 2=Fair, 3=Good, 4=Excellent). A positive value represents improvement in sleep quality.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Deviation|Mean
777649|NCT00772005|Secondary|Change From Baseline to Week 12 in Sleep Quality Rating|A sleep questionnaire was used to evaluate the effect of armodafinil on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 12 in participants' ratings of their quality of sleep as measured on a 4-point scale (1=Poor, 2=Fair, 3=Good, 4=Excellent). A positive value represents improvement in sleep quality.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
777650|NCT00772005|Secondary|Change From Baseline to Endpoint in Sleep Quality Rating|A sleep questionnaire was used to evaluate the effect of armodafinil on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to endpoint in participants' ratings of their quality of sleep as measured on a 4-point scale (1=Poor, 2=Fair, 3=Good, 4=Excellent). A positive value represents improvement in sleep quality.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
777651|NCT00772005|Secondary|Change From Baseline to Week 24 in Time Spent Asleep at Night|A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 24 in reported time spent asleep at night. A positive value indicates increased time spent asleep at night.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Minutes||Standard Deviation|Mean
777652|NCT00772005|Secondary|Change From Baseline to Week 12 in Time Spent Asleep at Night|A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 12 in reported time spent asleep at night. A positive value indicates increased time spent asleep at night.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Minutes||Standard Deviation|Mean
777653|NCT00772005|Secondary|Change From Baseline to Endpoint in Time Spent Asleep at Night|A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to endpoint in reported time spent asleep at night. A positive value indicates increased time spent asleep at night.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Minutes||Standard Deviation|Mean
777654|NCT00772005|Secondary|Change From Baseline to Week 24 in Time Spent Awake at Night|A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 24 in reported time spent awake at night. A positive value represents longer period awake at night.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Minutes||Standard Deviation|Mean
777818|NCT00772031|Secondary|Change From Baseline in Migraine-Specific Quality of Life (MSQ) - Emotional Function at 6 Months|The MSQ (version 2.1 copyrighted 1992, 1996, 1998 by Glaxo Wellcome Inc., Research Triangle Park, North Carolina) is a 14 item questionnaire. Item responses are summed and scored as a total score and three domains: Role Preventive, Role Restrictive, Emotional Function. Scores within each domain are rescaled to range from 0 to 100. A lower score indicates a poorer quality of life associated with that domain or in total. Because of the observed interaction within a domain, only domain scores were used as outcome measures for this study.|Baseline and 6 Months|||units on a scale||Standard Deviation|Mean
777655|NCT00772005|Secondary|Change From Baseline to Week 12 in Time Spent Awake at Night|A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 12 in reported time spent awake at night. A positive value represents longer period awake at night.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Minutes||Standard Deviation|Mean
777656|NCT00772005|Secondary|Change From Baseline to Endpoint in Time Spent Awake at Night|A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to endpoint in reported time spent awake at night. A positive value represents longer period awake at night.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Minutes||Standard Deviation|Mean
777657|NCT00772005|Secondary|Change From Baseline to Week 24 in Number of Nighttime Awakenings|A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 24 in reported number of nighttime awakenings. A positive value represents an increase in number of night time awakenings.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Awakenings||Standard Deviation|Mean
777658|NCT00772005|Secondary|Change From Baseline to Week 12 in Number of Nighttime Awakenings|A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 12 in reported number of nighttime awakenings. A positive value represents an increase in number of night time awakenings.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Awakenings||Standard Deviation|Mean
777659|NCT00772005|Secondary|Change From Baseline to Endpoint in Number of Nighttime Awakenings|A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to endpoint in reported number of nighttime awakenings. A positive value represents an increase in number of night time awakenings.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Awakenings||Standard Deviation|Mean
777660|NCT00772005|Secondary|Change From Baseline to Week 24 in Sleep Latency|A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient’s nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency (time till fall asleep), duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 24 in reported sleep latency. There is no range of possible values, positive values represent prolongation of sleep latency.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Minutes||Standard Deviation|Mean
777661|NCT00772005|Secondary|Change From Baseline to Week 12 in Sleep Latency|A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient’s nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency (time till fall asleep), duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 12 in reported sleep latency. There is no range of possible values, positive values represent prolongation of sleep latency.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Minutes||Standard Deviation|Mean
777662|NCT00772005|Secondary|Change From Baseline to Endpoint in Sleep Latency|A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient’s nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency (time till fall asleep), duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to endpoint in reported sleep latency. There is no range of possible values, positive values represent prolongation of sleep latency.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Minutes||Standard Deviation|Mean
777663|NCT00772005|Secondary|Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Ideations at Week 24|The C-SSRS was performed at weeks 8, 16, and 24 (or last observation after baseline), and at any time if clinically indicated. The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The data presented here represents the percentage of patients in each arm found to have suicidal ideation in the judgment of a clinician and based upon a clinicians interpretation of the subject's responses to the C-SSRS questions at week 24.|Week 24|The number of participants analyzed represents the number of participants with evaluable data.||Percentage of participants|||Number
778292|NCT00776230|Primary|Primary: 1. Geometric Mean Titers (GMT) at Day 56||56 days post 1st vaccination|Intention To Treat Population, i.e., all subjects entered into the study who received at least one dose of study medication||Geometric Mean Titer - Estimate||95% Confidence Interval|Geometric Mean
777664|NCT00772005|Secondary|Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Ideations at Week 16|The C-SSRS was performed at weeks 8, 16, and 24 (or last observation after baseline), and at any time if clinically indicated. The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The data presented here represents the percentage of patients in each arm found to have suicidal ideation in the judgment of a clinician and based upon a clinicians interpretation of the subject's responses to the C-SSRS questions at week 16.|Week 16|The number of participants analyzed represents the number of participants with evaluable data.||percentage of participants|||Number
777665|NCT00772005|Secondary|Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Ideations at Week 8|The C-SSRS was performed at weeks 8, 16, and 24 (or last observation after baseline), and at any time if clinically indicated. The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The data presented here represents the percentage of patients in each arm found to have suicidal ideation in the judgment of a clinician and based upon a clinicians interpretation of the subject's responses to the C-SSRS questions at week 8.|Week 8|The number of participants analyzed represents the number of participants with evaluable data.||Percentage of participants|||Number
777666|NCT00772005|Secondary|Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Ideations at Endpoint|The C-SSRS was performed at weeks 8, 16, and 24 (or last observation after baseline), and at any time if clinically indicated. The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The data presented here represents the percentage of patients in each arm found to have suicidal ideation in the judgment of a clinician and based upon a clinicians interpretation of the subject's responses to the C-SSRS questions at endpoint.|Endpoint (Week 24 or last observation)|The number of participants analyzed represents the number of participants with evaluable data.||Percentage of participants|||Number
777667|NCT00772005|Secondary|Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Behavior at Week 24|The C-SSRS was performed at weeks 8, 16, and 24 (or last observation after baseline), and at any time if clinically indicated. The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The data presented here represents the percentage of patients in each arm found to have suicidal behavior in the judgment of a clinician and based upon a clinicians interpretation of the subject's responses to the C-SSRS questions at week 24.|Week 24|The number of participants analyzed represents the number of participants with evaluable data.||Percentage of participants|||Number
777668|NCT00772005|Secondary|Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Behavior at Week 16|The C-SSRS was performed at weeks 8, 16, and 24 (or last observation after baseline), and at any time if clinically indicated. The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The data presented here represents the percentage of patients in each arm found to have suicidal behavior in the judgment of a clinician and based upon a clinicians interpretation of the subject's responses to the C-SSRS questions at week 16.|Week 16|The number of participants analyzed represents the number of participants with evaluable data.||Percentage of participants|||Number
777669|NCT00772005|Secondary|Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Behavior at Week 8|The C-SSRS was performed at weeks 8, 16, and 24 (or last observation after baseline), and at any time if clinically indicated. The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The data presented here represents the percentage of patients in each arm found to have suicidal behavior at week 8 in the judgment of a clinician and based upon a clinicians interpretation of the subject's responses to the C-SSRS questions.|Week 8|The number of participants analyzed represents the number of participants with evaluable data.||Percentage of participants|||Number
777670|NCT00772005|Secondary|Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Behavior at Endpoint|The C-SSRS was performed at weeks 8, 16, and 24 (or last observation after baseline), and at any time if clinically indicated. The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The data presented here represents the percentage of patients in each arm found to have suicidal behavior in the judgment of a clinician and based upon a clinicians interpretation of the subject's responses to the C-SSRS questions.|Endpoint (Week 24 or last observation)|The number of participants analyzed represents the number of participants with evaluable data.||Percentage of participants|||Number
777671|NCT00772005|Secondary|Change From Baseline to Week 24 in the Calgary Depression Scale for Schizophrenia (CDSS) Score|Calgary Depression Scale for Schizophrenia (CDSS) assesses the level of depression in patients with schizophrenia. Nine items (depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression) are each scored on a 4-point scale: 0=absent, 1=mild, 2=moderate, 3=severe. The total score is a sum of the scores of each item and may range from 0 to 27. Higher score more severe pathology. Data presented here represents the change from baseline to week 24, positive values represent worsening.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
777672|NCT00772005|Secondary|Change From Baseline to Week 20 in the Calgary Depression Scale for Schizophrenia (CDSS) Score|Calgary Depression Scale for Schizophrenia (CDSS) assesses the level of depression in patients with schizophrenia. Nine items (depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression) are each scored on a 4-point scale: 0=absent, 1=mild, 2=moderate, 3=severe. The total score is a sum of the scores of each item and may range from 0 to 27. Higher score more severe pathology. Data presented here represents the change from baseline to week 20, positive values represent worsening.|Baseline and Week 20|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
778293|NCT00776295|Secondary|3 Year Progression-free Survival|3 year progression-free survival (PFS) is defined as time from maximum response to relapse or progression of SCLC|up to 3 years|||participants|||Number
777673|NCT00772005|Secondary|Change From Baseline to Week 16 in the Calgary Depression Scale for Schizophrenia (CDSS) Score|Calgary Depression Scale for Schizophrenia (CDSS) assesses the level of depression in patients with schizophrenia. Nine items (depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression) are each scored on a 4-point scale: 0=absent, 1=mild, 2=moderate, 3=severe. The total score is a sum of the scores of each item and may range from 0 to 27. Higher score more severe pathology. Data presented here represents the change from baseline to week 16, positive values represent worsening.|Baseline and Week 16|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
777674|NCT00772005|Secondary|Change From Baseline to Week 12 in the Calgary Depression Scale for Schizophrenia (CDSS) Score|Calgary Depression Scale for Schizophrenia (CDSS) assesses the level of depression in patients with schizophrenia. Nine items (depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression) are each scored on a 4-point scale: 0=absent, 1=mild, 2=moderate, 3=severe. The total score is a sum of the scores of each item and may range from 0 to 27. Higher score more severe pathology. Data presented here represents the change from baseline to week 12, positive values represent worsening.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
777675|NCT00772005|Secondary|Change From Baseline to Week 8 in the Calgary Depression Scale for Schizophrenia (CDSS) Score|Calgary Depression Scale for Schizophrenia (CDSS) assesses the level of depression in patients with schizophrenia. Nine items (depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression) are each scored on a 4-point scale: 0=absent, 1=mild, 2=moderate, 3=severe. The total score is a sum of the scores of each item and may range from 0 to 27. Higher score more severe pathology. Data presented here represents the change from baseline to week 8, positive values represent worsening.|Baseline and Week 8|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
777676|NCT00772005|Secondary|Change From Baseline to Week 4 in the Calgary Depression Scale for Schizophrenia (CDSS) Score|Calgary Depression Scale for Schizophrenia (CDSS) assesses the level of depression in patients with schizophrenia. Nine items (depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression) are each scored on a 4-point scale: 0=absent, 1=mild, 2=moderate, 3=severe. The total score is a sum of the scores of each item and may range from 0 to 27. Higher score more severe pathology. Data presented here represents the change from baseline to week 4, positive values represent worsening.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
777677|NCT00772005|Secondary|Change From Baseline to Week 2 in the Calgary Depression Scale for Schizophrenia (CDSS) Score|Calgary Depression Scale for Schizophrenia (CDSS) assesses the level of depression in patients with schizophrenia. Nine items (depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression) are each scored on a 4-point scale: 0=absent, 1=mild, 2=moderate, 3=severe. The total score is a sum of the scores of each item and may range from 0 to 27. Higher score more severe pathology. Data presented here represents the change from baseline to week 2, positive values represent worsening.|Baseline and Week 2|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
777678|NCT00772005|Secondary|Change From Baseline to Week 1 in the Calgary Depression Scale for Schizophrenia (CDSS) Score|Calgary Depression Scale for Schizophrenia (CDSS) assesses the level of depression in patients with schizophrenia. Nine items (depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression) are each scored on a 4-point scale: 0=absent, 1=mild, 2=moderate, 3=severe. The total score is a sum of the scores of each item and may range from 0 to 27. Higher score more severe pathology. Data presented here represents the change from baseline to week 1, positive values represent worsening.|Baseline and Week 1|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
777679|NCT00772005|Secondary|Change From Baseline to Endpoint in the Calgary Depression Scale for Schizophrenia (CDSS) Score|Calgary Depression Scale for Schizophrenia (CDSS) assesses the level of depression in patients with schizophrenia. Nine items (depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression) are each scored on a 4-point scale: 0=absent, 1=mild, 2=moderate, 3=severe. The total score is a sum of the scores of each item and may range from 0 to 27. Higher score more severe pathology. Data presented here represents the change from baseline to endpoint, positive values represent worsening.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
777680|NCT00772005|Secondary|Change From Baseline to Week 24 in the Barnes Akathisia Rating Scale (BARS) Total Score|Barnes Akathisia Rating Scale (BARS) measures presence and severity of drug-induced akathisia. Items related to objective akathisia, subjective awareness of restlessness, and distress related to restlessness were rated using a 4-point scale: 0=normal/no distress, 1=presence of restlessness/mild distress, 2=observable restlessness/moderate distress, 3=constant restlessness/severe distress. Total score is sum of scores of each item and range from 0-9. Higher score indicates greater restlessness and distress. Data represent change from baseline to week 24, positive values represent worsening.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
777853|NCT00772538|Secondary|Time to First Severe Asthma Exacerbation During the 48-week Treatment.|Severe asthma exacerbations were pre-defined as all asthma exacerbations that required treatment with systemic (including oral) corticosteroids for at least 3 days or (in case of ongoing and pre-existing systemic corticosteroid therapy) that required at least a doubling of the previous daily dose of systemic corticosteroids for at least 3 days.|48 weeks|All patients from FAS. As <50percent (68 of 222 patients in the placebo group and 53 of 237 patients in the Tio R5 group) of patients had severe exacerbation, the median time was not calculable.|||||
777681|NCT00772005|Secondary|Change From Baseline to Week 20 in the Barnes Akathisia Rating Scale (BARS) Total Score|Barnes Akathisia Rating Scale (BARS) measures presence and severity of drug-induced akathisia. Items related to objective akathisia, subjective awareness of restlessness, and distress related to restlessness were rated using a 4-point scale: 0=normal/no distress, 1=presence of restlessness/mild distress, 2=observable restlessness/moderate distress, 3=constant restlessness/severe distress. Total score is sum of scores of each item and range from 0-9. Higher score indicates greater restlessness and distress. Data represent change from baseline to week 20, positive values represent worsening.|Baseline and Week 20|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
777682|NCT00772005|Secondary|Change From Baseline to Week 16 in the Barnes Akathisia Rating Scale (BARS) Total Score|Barnes Akathisia Rating Scale (BARS) measures presence and severity of drug-induced akathisia. Items related to objective akathisia, subjective awareness of restlessness, and distress related to restlessness were rated using a 4-point scale: 0=normal/no distress, 1=presence of restlessness/mild distress, 2=observable restlessness/moderate distress, 3=constant restlessness/severe distress. Total score is sum of scores of each item and range from 0-9. Higher score indicates greater restlessness and distress. Data represent change from baseline to week 16, positive values represent worsening.|Baseline and Week 16|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
777683|NCT00772005|Secondary|Change From Baseline to Week 12 in the Barnes Akathisia Rating Scale (BARS) Total Score|Barnes Akathisia Rating Scale (BARS) measures presence and severity of drug-induced akathisia. Items related to objective akathisia, subjective awareness of restlessness, and distress related to restlessness were rated using a 4-point scale: 0=normal/no distress, 1=presence of restlessness/mild distress, 2=observable restlessness/moderate distress, 3=constant restlessness/severe distress. Total score is sum of scores of each item and range from 0-9. Higher score indicates greater restlessness and distress. Data represent change from baseline to week 12, positive values represent worsening.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
777684|NCT00772005|Secondary|Change From Baseline to Week 8 in the Barnes Akathisia Rating Scale (BARS) Total Score|Barnes Akathisia Rating Scale (BARS) measures presence and severity of drug-induced akathisia. Items related to objective akathisia, subjective awareness of restlessness, and distress related to restlessness were rated using a 4-point scale: 0=normal/no distress, 1=presence of restlessness/mild distress, 2=observable restlessness/moderate distress, 3=constant restlessness/severe distress. Total score is sum of scores of each item and range from 0-9. Higher score indicates greater restlessness and distress. Data represent change from baseline to week 8, positive values represent worsening.|Baseline and Week 8|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
777685|NCT00772005|Secondary|Change From Baseline to Week 4 in the Barnes Akathisia Rating Scale (BARS) Total Score|Barnes Akathisia Rating Scale (BARS) measures presence and severity of drug-induced akathisia. Items related to objective akathisia, subjective awareness of restlessness, and distress related to restlessness were rated using a 4-point scale: 0=normal/no distress, 1=presence of restlessness/mild distress, 2=observable restlessness/moderate distress, 3=constant restlessness/severe distress. Total score is sum of scores of each item and range from 0-9. Higher score indicates greater restlessness and distress. Data represent change from baseline to week 4, positive values represent worsening.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
777686|NCT00772005|Secondary|Change From Baseline to Week 2 in the Barnes Akathisia Rating Scale (BARS) Total Score|Barnes Akathisia Rating Scale (BARS) measures presence and severity of drug-induced akathisia. Items related to objective akathisia, subjective awareness of restlessness, and distress related to restlessness were rated using a 4-point scale: 0=normal/no distress, 1=presence of restlessness/mild distress, 2=observable restlessness/moderate distress, 3=constant restlessness/severe distress. Total score is sum of scores of each item and range from 0-9. Higher score indicates greater restlessness and distress. Data represent change from baseline to week 2, positive values represent worsening.|Baseline and Week 2|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
777687|NCT00772005|Secondary|Change From Baseline to Week 1 in the Barnes Akathisia Rating Scale (BARS) Total Score|Barnes Akathisia Rating Scale (BARS) measures presence and severity of drug-induced akathisia. Items related to objective akathisia, subjective awareness of restlessness, and distress related to restlessness were rated using a 4-point scale: 0=normal/no distress, 1=presence of restlessness/mild distress, 2=observable restlessness/moderate distress, 3=constant restlessness/severe distress. Total score is sum of scores of each item and range from 0-9. Higher score indicates greater restlessness and distress. Data represent change from baseline to week 1, positive values represent worsening.|Baseline and Week 1|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
777688|NCT00772005|Secondary|Change From Baseline to Endpoint in the Barnes Akathisia Rating Scale (BARS) Total Score|Barnes Akathisia Rating Scale (BARS) measures presence and severity of drug-induced akathisia. Items related to objective akathisia, subjective awareness of restlessness, and distress related to restlessness were rated using a 4-point scale: 0=normal/no distress, 1=presence of restlessness/mild distress, 2=observable restlessness/moderate distress, 3=constant restlessness/severe distress. Total score is sum of scores of each item and range from 0-9. Higher score indicates greater restlessness and distress. Data represent change from baseline to endpoint, positive values represent worsening.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
777867|NCT00772538|Secondary|Trough FVC Response at the End of the 24-week Treatment Period.|The trough FVC is defined as the pre-dose FVC measured 10 minutes before the last administration of randomised treatment. Trough FVC response was defined as the difference between the trough FVC measured after a treatment period of 24 weeks and the FVC baseline measurement. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 24 weeks|All patients from FAS.||Liter||Standard Error|Mean
777689|NCT00772005|Secondary|Changes From Baseline to Week 24 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score|The Simpson-Angus EPS Scale is a clinician-rated scale to assess parkinsonian and extrapyramidal symptoms (10 items) associated with antipsychotic medications. Each item is rated on a 5-point scale. In addition, this scale was used to evaluate and characterize adverse events of extrapyramidal symptoms. Total scores are calculated by summing the scores of each item (minimum 0, maximum 40) and dividing by the number of items (10). Scores can range from 0-4. A higher score indicates more severe symptoms. Data represents change from baseline to week 24, positive values represent worsening.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
777690|NCT00772005|Secondary|Changes From Baseline to Week 20 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score|The Simpson-Angus EPS Scale is a clinician-rated scale to assess parkinsonian and extrapyramidal symptoms (10 items) associated with antipsychotic medications. Each item is rated on a 5-point scale. In addition, this scale was used to evaluate and characterize adverse events of extrapyramidal symptoms. Total scores are calculated by summing the scores of each item (minimum 0, maximum 40) and dividing by the number of items (10). Scores can range from 0-4. A higher score indicates more severe symptoms. Data represents change from baseline to week 20, positive values represent worsening.|Baseline and Week 20|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
777691|NCT00772005|Secondary|Changes From Baseline to Week 16 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score|The Simpson-Angus EPS Scale is a clinician-rated scale to assess parkinsonian and extrapyramidal symptoms (10 items) associated with antipsychotic medications. Each item is rated on a 5-point scale. In addition, this scale was used to evaluate and characterize adverse events of extrapyramidal symptoms. Total scores are calculated by summing the scores of each item (minimum 0, maximum 40) and dividing by the number of items (10). Scores can range from 0-4. A higher score indicates more severe symptoms. Data represents change from baseline to week 16, positive values represent worsening.|Baseline and Week 16|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
777692|NCT00772005|Secondary|Changes From Baseline to Week 12 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score|The Simpson-Angus EPS Scale is a clinician-rated scale to assess parkinsonian and extrapyramidal symptoms (10 items) associated with antipsychotic medications. Each item is rated on a 5-point scale. In addition, this scale was used to evaluate and characterize adverse events of extrapyramidal symptoms. Total scores are calculated by summing the scores of each item (minimum 0, maximum 40) and dividing by the number of items (10). Scores can range from 0-4. A higher score indicates more severe symptoms. Data represents change from baseline to week 12, positive values represent worsening.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
777693|NCT00772005|Secondary|Changes From Baseline to Week 8 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score|The Simpson-Angus EPS Scale is a clinician-rated scale to assess parkinsonian and extrapyramidal symptoms (10 items) associated with antipsychotic medications. Each item is rated on a 5-point scale. In addition, this scale was used to evaluate and characterize adverse events of extrapyramidal symptoms. Total scores are calculated by summing the scores of each item (minimum 0, maximum 40) and dividing by the number of items (10). Scores can range from 0-4. A higher score indicates more severe symptoms. Data represents change from baseline to week 8, positive values represent worsening.|Baseline and Week 8|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
777694|NCT00772005|Secondary|Changes From Baseline to Week 4 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score|The Simpson-Angus EPS Scale is a clinician-rated scale to assess parkinsonian and extrapyramidal symptoms (10 items) associated with antipsychotic medications. Each item is rated on a 5-point scale. In addition, this scale was used to evaluate and characterize adverse events of extrapyramidal symptoms. Total scores are calculated by summing the scores of each item (minimum 0, maximum 40) and dividing by the number of items (10). Scores can range from 0-4. A higher score indicates more severe symptoms. Data represents change from baseline to week 4, positive values represent worsening.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
777695|NCT00772005|Secondary|Changes From Baseline to Week 2 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score|The Simpson-Angus EPS Scale is a clinician-rated scale to assess parkinsonian and extrapyramidal symptoms (10 items) associated with antipsychotic medications. Each item is rated on a 5-point scale. In addition, this scale was used to evaluate and characterize adverse events of extrapyramidal symptoms. Total scores are calculated by summing the scores of each item (minimum 0, maximum 40) and dividing by the number of items (10). Scores can range from 0-4. A higher score indicates more severe symptoms. Data represents change from baseline to week 2, positive values represent worsening.|Baseline and Week 2|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
777696|NCT00772005|Secondary|Changes From Baseline to Week 1 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score|The Simpson-Angus EPS Scale is a clinician-rated scale to assess parkinsonian and extrapyramidal symptoms (10 items) associated with antipsychotic medications. Each item is rated on a 5-point scale. In addition, this scale was used to evaluate and characterize adverse events of extrapyramidal symptoms. Total scores are calculated by summing the scores of each item (minimum 0, maximum 40) and dividing by the number of items (10). Scores can range from 0-4. A higher score indicates more severe symptoms. Data represents change from baseline to week 1, positive values represent worsening.|Baseline and Week 1|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
777868|NCT00772538|Secondary|Peak (Within 3 Hours Post-dosing) Forced Vital Capacity (FVC) Response at the End of the 24-week Treatment Period.|Peak FVC 0-3h response was defined as the difference between the maximum FVC measured within the first 3 hours post dosing after a treatment period of 24 weeks and the FVC baseline measurement (10 minutes before the first dose of trial medication). Mixed Model Repeated Measure (MMRM) results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 24 weeks|All patients from FAS.||Liter||Standard Error|Mean
777697|NCT00772005|Secondary|Changes From Baseline to Endpoint in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score|The Simpson-Angus EPS Scale is a clinician-rated scale to assess parkinsonian and extrapyramidal symptoms (10 items) associated with antipsychotic medications. Each item is rated on a 5-point scale. In addition, this scale was used to evaluate and characterize adverse events of extrapyramidal symptoms. Total scores are calculated by summing the scores of each item (minimum 0, maximum 40) and dividing by the number of items (10). Scores can range from 0-4. A higher score indicates more severe symptoms. Data represents change from baseline to endpoint, positive values represent worsening.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
777698|NCT00772005|Secondary|Changes From Baseline to Week 24 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores|Abnormal Involuntary Movement Scale (AIMS) is a 14-item, clinician-rated scale to assess the severity of dyskinesias in patients taking neuroleptic drugs. Items 1 through 10 were rated using a 5-point (0-4) scale, items 11 through 14 were rated using a 2-point (no or yes) scale. The AIMS total score is the sum of items 1 through 10, and can range from 0-40. A higher score indicates a presence of more severe dyskinesias. Data represents change from baseline to week 24, positive value represents worsening.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
777699|NCT00772005|Secondary|Changes From Baseline to Week 20 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores|Abnormal Involuntary Movement Scale (AIMS) is a 14-item, clinician-rated scale to assess the severity of dyskinesias in patients taking neuroleptic drugs. Items 1 through 10 were rated using a 5-point (0-4) scale, items 11 through 14 were rated using a 2-point (no or yes) scale. The AIMS total score is the sum of items 1 through 10, and can range from 0-40. A higher score indicates a presence of more severe dyskinesias. Data represents change from baseline to week 20, positive value represents worsening.|Baseline and Week 20|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
777700|NCT00772005|Secondary|Changes From Baseline to Week 16 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores|Abnormal Involuntary Movement Scale (AIMS) is a 14-item, clinician-rated scale to assess the severity of dyskinesias in patients taking neuroleptic drugs. Items 1 through 10 were rated using a 5-point (0-4) scale, items 11 through 14 were rated using a 2-point (no or yes) scale. The AIMS total score is the sum of items 1 through 10, and can range from 0-40. A higher score indicates a presence of more severe dyskinesias. Data represents change from baseline to week 16, positive value represents worsening.|Baseline and Week 16|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
777701|NCT00772005|Secondary|Changes From Baseline to Week 12 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores|Abnormal Involuntary Movement Scale (AIMS) is a 14-item, clinician-rated scale to assess the severity of dyskinesias in patients taking neuroleptic drugs. Items 1 through 10 were rated using a 5-point (0-4) scale, items 11 through 14 were rated using a 2-point (no or yes) scale. The AIMS total score is the sum of items 1 through 10, and can range from 0-40. A higher score indicates a presence of more severe dyskinesias. Data represents change from baseline to week 12, positive value represents worsening.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
777702|NCT00772005|Secondary|Changes From Baseline to Week 8 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores|Abnormal Involuntary Movement Scale (AIMS) is a 14-item, clinician-rated scale to assess the severity of dyskinesias in patients taking neuroleptic drugs. Items 1 through 10 were rated using a 5-point (0-4) scale, items 11 through 14 were rated using a 2-point (no or yes) scale. The AIMS total score is the sum of items 1 through 10, and can range from 0-40. A higher score indicates a presence of more severe dyskinesias. Data represents change from baseline to week 8, positive value represents worsening.|Baseline and Week 8|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
777703|NCT00772005|Secondary|Changes From Baseline to Week 4 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores|Abnormal Involuntary Movement Scale (AIMS) is a 14-item, clinician-rated scale to assess the severity of dyskinesias in patients taking neuroleptic drugs. Items 1 through 10 were rated using a 5-point (0-4) scale, items 11 through 14 were rated using a 2-point (no or yes) scale. The AIMS total score is the sum of items 1 through 10, and can range from 0-40. A higher score indicates a presence of more severe dyskinesias. Data represents change from baseline to week 4, positive value represents worsening.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
777704|NCT00772005|Secondary|Changes From Baseline to Week 2 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores|Abnormal Involuntary Movement Scale (AIMS) is a 14-item, clinician-rated scale to assess the severity of dyskinesias in patients taking neuroleptic drugs. Items 1 through 10 were rated using a 5-point (0-4) scale, items 11 through 14 were rated using a 2-point (no or yes) scale. The AIMS total score is the sum of items 1 through 10, and can range from 0-40. A higher score indicates a presence of more severe dyskinesias. Data represents change from baseline to week 2, positive value represents worsening.|Baseline and Week 2|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
777705|NCT00772005|Secondary|Changes From Baseline to Week 1 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores|Abnormal Involuntary Movement Scale (AIMS) is a 14-item, clinician-rated scale to assess the severity of dyskinesias in patients taking neuroleptic drugs. Items 1 through 10 were rated using a 5-point (0-4) scale, items 11 through 14 were rated using a 2-point (no or yes) scale. The AIMS total score is the sum of items 1 through 10, and can range from 0-40. A higher score indicates a presence of more severe dyskinesias. Data represents change from baseline to week 1, positive value represents worsening.|Baseline and Week 1|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
778294|NCT00776295|Primary|Number of Subjects Meeting 1-year Overall Survival|Number of participants with overall survival from first day of cyclophosphamide and GM-CSF mobilization to the day of death|up to one year|||participants|||Number
777706|NCT00772005|Secondary|Changes From Baseline to Endpoint in the Abnormal Involuntary Movement Scale (AIMS) Total Scores|Abnormal Involuntary Movement Scale (AIMS) is a 14-item, clinician-rated scale to assess the severity of dyskinesias in patients taking neuroleptic drugs. Items 1 through 10 were rated using a 5-point (0-4) scale, items 11 through 14 were rated using a 2-point (no or yes) scale. The AIMS total score is the sum of items 1 through 10, and can range from 0-40. A higher score indicates a presence of more severe dyskinesias. Data represents change from baseline to endpoint, positive value represents worsening.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
777707|NCT00772005|Secondary|Mean Change From Baseline to Week 24 in CNSVitalSigns Cognitive Battery Scores - 4-part Continuous Performance Test [CPT]|The 4-Part Continuous Performance Test (CPT) is a component of the CNSVitalSigns cognitive battery. The 4-Part CPT assesses working memory. The patient was presented with targets and had to remember target presentation sequencing in order to respond to the directions. The complexity of the directions increased as the patient proceeded through the 4 parts of the test. Scoring is based on the number of correct responses, with a higher number indicating more correct responses. Data represents change from baseline to week 24 with positive values demonstrating improvement.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Correct responses||Standard Error|Least Squares Mean
777708|NCT00772005|Secondary|Mean Change From Baseline to Week 12 in CNSVitalSigns Cognitive Battery Scores - 4-part Continuous Performance Test [CPT]|The 4-Part Continuous Performance Test (CPT) is a component of the CNSVitalSigns cognitive battery. The 4-Part CPT assesses working memory. The patient was presented with targets and had to remember target presentation sequencing in order to respond to the directions. The complexity of the directions increased as the patient proceeded through the 4 parts of the test. Scoring is based on the number of correct responses, with a higher number indicating more correct responses. Data represents change from baseline to week 12 with positive values demonstrating improvement.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Correct responses||Standard Error|Least Squares Mean
777709|NCT00772005|Secondary|Mean Change From Baseline to Endpoint in CNSVitalSigns Cognitive Battery Scores - 4-part Continuous Performance Test [CPT]|The 4-Part Continuous Performance Test (CPT) is a component of the CNSVitalSigns cognitive battery. The 4-Part CPT assesses working memory. The patient was presented with targets and had to remember target presentation sequencing in order to respond to the directions. The complexity of the directions increased as the patient proceeded through the 4 parts of the test. Scoring is based on the number of correct responses, with a higher number indicating more correct responses. Data represents change from baseline to endpoint with positive values demonstrating improvement.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Correct responses||Standard Error|Least Squares Mean
777710|NCT00772005|Secondary|Mean Change From Baseline to Week 24 in CNSVitalSigns Cognitive Battery Scores - Shifting Attention Test|The Shifting Attention Test is a test in the CNSVitalSigns cognitive battery. The Shifting Attention Test assesses attention and executive function. Patients were instructed to match geometric objects either by shape or by color. Composite Scoring presented here was calculated as the number of correct responses minus the number of errors. A higher score indicates more correct responses. The data represent the change from baseline to week 24 and a positive value represents improvement.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Correct responses minus errors||Standard Error|Least Squares Mean
777711|NCT00772005|Secondary|Mean Change From Baseline to Week 12 in CNSVitalSigns Cognitive Battery Scores - Shifting Attention Test|The Shifting Attention Test is a test in the CNSVitalSigns cognitive battery. The Shifting Attention Test assesses attention and executive function. Patients were instructed to match geometric objects either by shape or by color. Composite Scoring presented here was calculated as the number of correct responses minus the number of errors. A higher score indicates more correct responses. The data represent the change from baseline to week 12 and a positive value represents improvement.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Correct responses minus errors||Standard Error|Least Squares Mean
777712|NCT00772005|Secondary|Mean Change From Baseline to Endpoint in CNSVitalSigns Cognitive Battery Scores - Shifting Attention Test|The Shifting Attention Test is a test in the CNSVitalSigns cognitive battery. The Shifting Attention Test assesses attention and executive function. Patients were instructed to match geometric objects either by shape or by color. Composite Scoring presented here was calculated as the number of correct responses minus the number of errors. A higher score indicates more correct responses. The data represent the change from baseline to endpoint and a positive value represents improvement.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Correct responses minue errors||Standard Error|Least Squares Mean
777713|NCT00772005|Secondary|Mean Change From Baseline to Week 24 in CNSVitalSigns Cognitive Battery Scores - Symbol-digit Coding Test|Symbol-digit coding test (SDCT) is one test in the CNSVitalSigns cognitive battery. SDCT assesses speed of processing. Subject is taught to link numbers to digits. The test consists of serial presentations of screens, each of which contains a bank of 8 symbols above and 8 empty boxes below. The subject types in the number that corresponds to the symbol highlighted. Scoring is the number of correct responses generated in 2 minutes. A higher score indicates greater processing speed. Data represents change from baseline to week 24 with positive values representing improvement.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Number of correct responses||Standard Error|Least Squares Mean
777819|NCT00772031|Secondary|Change From Baseline in Migraine-Specific Quality of Life (MSQ)-Role Preventive at 6 Months|The MSQ (version 2.1 copyrighted 1992, 1996, 1998 by Glaxo Wellcome Inc., Research Triangle Park, North Carolina) is a 14 item questionnaire. Item responses are summed and scored as a total score and three domains: Role Preventive, Role Restrictive, Emotional Function. Scores within each domain are rescaled to range from 0 to 100. A lower score indicates a poorer quality of life associated with that domain or in total. Because of the observed interaction within a domain, only domain scores were used as outcome measures for this study.|Baseline and 6 months|||units on a scale||Standard Deviation|Mean
777714|NCT00772005|Secondary|Mean Change From Baseline to Week 12 in CNSVitalSigns Cognitive Battery Scores - Symbol-digit Coding Test|Symbol-digit coding test (SDCT) is one test in the CNSVitalSigns cognitive battery. SDCT assesses speed of processing. Subject is taught to link numbers to digits. The test consists of serial presentations of screens, each of which contains a bank of 8 symbols above and 8 empty boxes below. The subject types in the number that corresponds to the symbol highlighted. Scoring is the number of correct responses generated in 2 minutes. A higher score indicates greater processing speed. Data represents change from baseline to week 12 with positive values representing improvement.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Number of correct responses||Standard Error|Least Squares Mean
777715|NCT00772005|Secondary|Mean Change From Baseline to Endpoint in CNSVitalSigns Cognitive Battery Scores - Symbol-digit Coding Test (SDCT)|Symbol-digit coding test (SDCT) is one test in the CNSVitalSigns cognitive battery. SDCT assesses speed of processing. Subject is taught to link numbers to digits. The test consists of serial presentations of screens, each of which contains a bank of 8 symbols above and 8 empty boxes below. The subject types in the number that corresponds to the symbol highlighted. Scoring is the number of correct responses generated in 2 minutes. A higher score indicates greater processing speed. Data represents change from baseline to endpoint with positive values representing improvement.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Number of correct responses||Standard Error|Least Squares Mean
777716|NCT00772005|Secondary|Mean Change From Baseline to Week 24 in CNSVitalSigns Cognitive Battery Scores - Verbal Memory Test|"CNSVitalSigns cognitive battery consists of 4 tests (Verbal Memory, Symbol-Digit Coding Test, Shifting Attention Test, Continuous Performance Test [CPT]). With Verbal Memory Test, patient asked to remember 15 words within a field of 15 distractors immediately and after twenty minute delay. Score is the sum of correct immediate hits, correct immediate passes, correct delayed hits, and correct delayed passes. Total score may range from 0 to 60, with a higher score indicating more correct responses. Data represents change from baseline to week 24, with positive score showing improvement."|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Error|Least Squares Mean
777717|NCT00772005|Secondary|Mean Change From Baseline to Week 12 in CNSVitalSigns Cognitive Battery Scores - Verbal Memory Test|"CNSVitalSigns cognitive battery consists of 4 tests (Verbal Memory, Symbol-Digit Coding Test, Shifting Attention Test, Continuous Performance Test [CPT]). With Verbal Memory Test, patient asked to remember 15 words within a field of 15 distractors immediately and after twenty minute delay. Score is the sum of correct immediate hits, correct immediate passes, correct delayed hits, and correct delayed passes. Total score may range from 0 to 60, with a higher score indicating more correct responses. Data represents change from baseline to week 12, with positive score showing improvement."|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Error|Least Squares Mean
777718|NCT00772005|Secondary|Mean Change From Baseline to Endpoint in CNSVitalSigns Cognitive Battery Scores - Verbal Memory Test|"CNSVitalSigns cognitive battery consists of 4 tests (Verbal Memory, Symbol-Digit Coding Test, Shifting Attention Test, Continuous Performance Test [CPT]). With Verbal Memory Test, patient asked to remember 15 words within a field of 15 distractors immediately and after twenty minute delay. Score is the sum of correct immediate hits, correct immediate passes, correct delayed hits, and correct delayed passes. Total score may range from 0 to 60, with a higher score indicating more correct responses. Data represents change from baseline to endpoint, with positive score showing improvement."|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Error|Least Squares Mean
777719|NCT00772005|Secondary|Mean Change From Baseline to Week 24 in Personal and Social Performance Scale (PSP) Scores|PSP is a validated clinician-rated assessment of functioning. Four areas of functioning (socially useful activities, personal/social relationships, self-care, disturbing/aggressive behaviors) are assessed on a 6-point scale (0=absent to 5=very severe). A transformed score from 1 to 100 is generated from the raw score based on the clinical interpretation of the scores generated in the 4 areas of functioning, with a higher transformed score indicating better function. Data presented here represents change from baseline to week 24 in the overall score with positive values signifying improvement.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Error|Least Squares Mean
777720|NCT00772005|Secondary|Mean Change From Baseline to Week 12 in Personal and Social Performance Scale (PSP) Scores|PSP is a validated clinician-rated assessment of functioning. Four areas of functioning (socially useful activities, personal/social relationships, self-care, disturbing/aggressive behaviors) are assessed on a 6-point scale (0=absent to 5=very severe). A transformed score from 1 to 100 is generated from the raw score based on the clinical interpretation of the scores generated in the 4 areas of functioning, with a higher transformed score indicating better function. Data presented here represents change from baseline to week 12 in the overall score with positive values signifying improvement.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Error|Least Squares Mean
777721|NCT00772005|Secondary|Mean Change From Baseline to Week 4 in Personal and Social Performance Scale (PSP) Scores|PSP is a validated clinician-rated assessment of functioning. Four areas of functioning (socially useful activities, personal/social relationships, self-care, disturbing/aggressive behaviors) are assessed on a 6-point scale (0=absent to 5=very severe). A transformed score from 1 to 100 is generated from the raw score based on the clinical interpretation of the scores generated in the 4 areas of functioning, with a higher transformed score indicating better function. Data presented here represents change from baseline to week 4 in the overall score with positive values signifying improvement.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Error|Least Squares Mean
777722|NCT00772005|Secondary|Mean Change From Baseline to Endpoint in Personal and Social Performance Scale (PSP) Scores|PSP is a validated clinician-rated assessment of functioning. Four areas of functioning (socially useful activities, personal/social relationships, self-care, disturbing/aggressive behaviors) are assessed on a 6-point scale (0=absent to 5=very severe). A transformed score from 1 to 100 is generated from the raw score based on the clinical interpretation of the scores generated in the 4 areas of functioning, with a higher transformed score indicating better function. Data presented here represents change from baseline to endpoint in the overall score with positive values signifying improvement.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Error|Least Squares Mean
777723|NCT00772005|Secondary|Change From Baseline to Week 24 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 24 in the CGI-S rating. A negative value indicates improvement.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Error|Least Squares Mean
777724|NCT00772005|Secondary|Change From Baseline to Week 22 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 22 in the CGI-S rating. A negative value indicates improvement.|Baseline and Week 22|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Error|Least Squares Mean
777725|NCT00772005|Secondary|Change From Baseline to Week 20 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 20 in the CGI-S rating. A negative value indicates improvement.|Baseline and Week 20|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Error|Least Squares Mean
777726|NCT00772005|Secondary|Change From Baseline to Week 18 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 18 in the CGI-S rating. A negative value indicates improvement.|Baseline and Week 18|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Error|Least Squares Mean
777727|NCT00772005|Secondary|Change From Baseline to Week 16 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 16 in the CGI-S rating. A negative value indicates improvement.|Baseline and Week 16|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Error|Least Squares Mean
777728|NCT00772005|Secondary|Change From Baseline to Week 14 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 14 in the CGI-S rating. A negative value indicates improvement.|Baseline and Week 14|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Error|Least Squares Mean
777729|NCT00772005|Secondary|Change From Baseline to Week 12 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 12 in the CGI-S rating. A negative value indicates improvement.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Error|Least Squares Mean
777820|NCT00772031|Secondary|Change From Baseline in Migraine Specific Quality of Life (MSQ)-Role Restrictive Score at 6 Months|The MSQ (version 2.1 copyrighted 1992, 1996, 1998 by Glaxo Wellcome Inc., Research Triangle Park, North Carolina) is a 14 item questionnaire. Item responses are summed and scored as a total score and three domains: Role Preventive, Role Restrictive, Emotional Function. Scores within each domain are rescaled to range from 0 to 100. A lower score indicates a poorer quality of life associated with that domain or in total. Because of the observed interaction within a domain, only domain scores were used as outcome measures for this study.|baseline and 6 months post randomization|per protocol||units on a scale||Standard Deviation|Mean
777730|NCT00772005|Secondary|Change From Baseline to Week 10 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 10 in the CGI-S rating. A negative value indicates improvement.|Baseline and Week 10|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Error|Least Squares Mean
777731|NCT00772005|Secondary|Change From Baseline to Week 8 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 8 in the CGI-S rating. A negative value indicates improvement.|Baseline and Week 8|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Error|Least Squares Mean
777732|NCT00772005|Secondary|Change From Baseline to Week 6 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 6 in the CGI-S rating. A negative value indicates improvement.|Baseline and Week 6|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Error|Least Squares Mean
777733|NCT00772005|Secondary|Change From Baseline to Week 4 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 4 in the CGI-S rating. A negative value indicates improvement.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Error|Least Squares Mean
777734|NCT00772005|Secondary|Change From Baseline to Week 2 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 2 in the CGI-S rating. A negative value indicates improvement.|Baseline and Week 2|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
777735|NCT00772005|Secondary|Change From Baseline to Week 1 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 1 in the CGI-S rating. A negative value indicates improvement.|Baseline and Week 1|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
777736|NCT00772005|Secondary|Change From Baseline to Endpoint in the Clinical Global Impression of Severity of Illness (CGI-S) Rating|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to endpoint in the CGI-S rating. A negative value indicates improvement.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
777737|NCT00772005|Secondary|Mean Change From Baseline to Week 24 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 24. Higher (positive) score indicates worsening.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
777821|NCT00772031|Secondary|Change From Baseline in Migraine Disability Assessment (MIDAS) Score at 6 Months|MIDAS scoring ranges from 0 to 270. The scores are divided into ranges of disability with higher scores indicating increased disability as follows: 0-5 (Grade I - Minimal or infrequent disability); 6-10 (Grade II - Mild or infrequent disability); 11-20 (Grade III - Moderate disability); and 21+ (Grade IV - Severe disability).|Baseline and 6 months|per protocol||units on a scale||Standard Deviation|Mean
779688|NCT00793572|Secondary|Incidence of Grades II-IV Acute GVHD|Confidence intervals will be estimated.|100 days post allo|||Participants|||Count of Participants
777738|NCT00772005|Secondary|Mean Change From Baseline to Week 20 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 20. Higher (positive) score indicates worsening.|Baseline and Week 20|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
777739|NCT00772005|Secondary|Mean Change From Baseline to Week 16 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 16. Higher (positive) score indicates worsening.|Baseline and Week 16|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
777740|NCT00772005|Secondary|Mean Change From Baseline to Week 12 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 12. Higher (positive) score indicates worsening.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
777741|NCT00772005|Secondary|Mean Change From Baseline to Week 8 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 8. Higher (positive) score indicates worsening.|Baseline and Week 8|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
777742|NCT00772005|Secondary|Mean Change From Baseline to Week 4 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 4. Higher (positive) score indicates worsening.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
777743|NCT00772005|Secondary|Mean Change From Baseline to Week 2 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 2. Higher (positive) score indicates worsening.|Baseline and Week 2|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
777744|NCT00772005|Secondary|Mean Change From Baseline to Week 1 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 1. Higher (positive) score indicates worsening.|Baseline and Week 1|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
777745|NCT00772005|Secondary|Mean Change From Baseline to Endpoint From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to endpoint. Higher (positive) score indicates worsening.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
777901|NCT00772889|Secondary|Haemagglutination Inhibition (HI) Antibody Titers|Antibody titers were expressed as Geometric mean titres (GMTs) per separate vaccine strain. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|Day 0-21|Analysis was performed on According-to-Protocol (ATP) Immunogenicity cohort. This cohort included all evaluable subjects for whom data concerning immunogenicity were available.||titer||95% Confidence Interval|Geometric Mean
777746|NCT00772005|Secondary|Mean Change From Baseline to Week 24 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in schizophrenics. Disorganized thought dimension is the sum of 1 positive symptom (conceptual disorganization), 1 negative symptom (difficulty in abstract thinking), and 5 general psychopathology symptoms (mannerisms and posturing, disorientation, poor attention, disturbance of volition, preoccupation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 7 to 49. Higher (positive) score indicates worsening. Data indicates change from baseline to week 24.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
777747|NCT00772005|Secondary|Mean Change From Baseline to Week 20 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in schizophrenics. Disorganized thought dimension is the sum of 1 positive symptom (conceptual disorganization), 1 negative symptom (difficulty in abstract thinking), and 5 general psychopathology symptoms (mannerisms and posturing, disorientation, poor attention, disturbance of volition, preoccupation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 7 to 49. Higher (positive) score indicates worsening. Data indicates change from baseline to week 20.|Baseline and Week 20|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
777748|NCT00772005|Secondary|Mean Change From Baseline to Week 16 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in schizophrenics. Disorganized thought dimension is the sum of 1 positive symptom (conceptual disorganization), 1 negative symptom (difficulty in abstract thinking), and 5 general psychopathology symptoms (mannerisms and posturing, disorientation, poor attention, disturbance of volition, preoccupation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 7 to 49. Higher (positive) score indicates worsening. Data indicates change from baseline to week 16.|Baseline and Week 16|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
777749|NCT00772005|Secondary|Mean Change From Baseline to Week 12 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in schizophrenics. Disorganized thought dimension is the sum of 1 positive symptom (conceptual disorganization), 1 negative symptom (difficulty in abstract thinking), and 5 general psychopathology symptoms (mannerisms and posturing, disorientation, poor attention, disturbance of volition, preoccupation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 7 to 49. Higher (positive) score indicates worsening. Data indicates change from baseline to week 12.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
777750|NCT00772005|Secondary|Mean Change From Baseline to Week 8 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in schizophrenics. Disorganized thought dimension is the sum of 1 positive symptom (conceptual disorganization), 1 negative symptom (difficulty in abstract thinking), and 5 general psychopathology symptoms (mannerisms and posturing, disorientation, poor attention, disturbance of volition, preoccupation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 7 to 49. Higher (positive) score indicates worsening. Data indicates change from baseline to week 8.|Baseline and Week 8|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
777751|NCT00772005|Secondary|Mean Change From Baseline to Week 4 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in schizophrenics. Disorganized thought dimension is the sum of 1 positive symptom (conceptual disorganization), 1 negative symptom (difficulty in abstract thinking), and 5 general psychopathology symptoms (mannerisms and posturing, disorientation, poor attention, disturbance of volition, preoccupation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 7 to 49. Higher (positive) score indicates worsening. Data indicates change from baseline to week 4.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
777752|NCT00772005|Secondary|Mean Change From Baseline to Week 2 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in schizophrenics. Disorganized thought dimension is the sum of 1 positive symptom (conceptual disorganization), 1 negative symptom (difficulty in abstract thinking), and 5 general psychopathology symptoms (mannerisms and posturing, disorientation, poor attention, disturbance of volition, preoccupation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 7 to 49. Higher (positive) score indicates worsening. Data indicates change from baseline to week 2.|Baseline and Week 2|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
777753|NCT00772005|Secondary|Mean Change From Baseline to Week 1 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in schizophrenics. Disorganized thought dimension is the sum of 1 positive symptom (conceptual disorganization), 1 negative symptom (difficulty in abstract thinking), and 5 general psychopathology symptoms (mannerisms and posturing, disorientation, poor attention, disturbance of volition, preoccupation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 7 to 49. Higher (positive) score indicates worsening. Data indicates change from baseline to week 1.|Baseline and Week 1|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
777978|NCT00773461|Secondary|Change in C-Reactive Protein From Baseline to Week 24|The serum concentration of CRP an acute phase inflammatory marker, is measured in milligrams/deciliter (mg/dL). A reduction in the level is considered an improvement.|Baseline and Week 24|ITT Population||mg/dL||Standard Deviation|Mean
777754|NCT00772005|Secondary|Mean Change From Baseline to Endpoint From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in schizophrenic patients. Disorganized thought dimension is the sum of 1 positive symptom (conceptual disorganization), 1 negative symptom (difficulty in abstract thinking), and 5 general psychopathology symptoms (mannerisms/posturing, disorientation, poor attention, disturbance of volition, preoccupation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 7 to 49. Higher (positive) score indicates worsening. Data indicates change from baseline to endpoint.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
777755|NCT00772005|Secondary|Mean Change From Baseline to Week 24 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 24. Higher (positive) scores indicate worsening.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
777756|NCT00772005|Secondary|Mean Change From Baseline to Week 20 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 20. Higher (positive) scores indicate worsening.|Baseline and Week 20|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
777757|NCT00772005|Secondary|Mean Change From Baseline to Week 16 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 16. Higher (positive) scores indicate worsening.|Baseline and Week 16|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
777758|NCT00772005|Secondary|Mean Change From Baseline to Week 12 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 12. Higher (positive) scores indicate worsening.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
777759|NCT00772005|Secondary|Mean Change From Baseline to Week 8 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 8. Higher (positive) scores indicate worsening.|Baseline and Week 8|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
777760|NCT00772005|Secondary|Mean Change From Baseline to Week 4 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 4. Higher (positive) scores indicate worsening.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
777761|NCT00772005|Secondary|Mean Change From Baseline to Week 2 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 2. Higher (positive) scores indicate worsening.|Baseline and Week 2|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
777822|NCT00772031|Secondary|Change From Baseline in Beck's Depression Inventory FastScreen Score at 6 Months|Total score from Beck's Depression Inventory FastScreen at 6 months minus total score from Beck's Depression Inventory FastScreen at baseline. Scale scores range from 0 to 21 with higher values indicating worsening depression. the following categories separate participants into groups of depression levels: Minimal (Score 0-3), Mild (Score 4-8),Moderate (Score 9-12),Severe (Score 13-21).|Baseline and 6 months|The number who completed the Beck's Depression Inventory at baseline and three months||units on a scale||Standard Deviation|Mean
777762|NCT00772005|Secondary|Mean Change From Baseline to Week 1 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 1. Higher (positive) scores indicate worsening.|Baseline and Week 1|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
777763|NCT00772005|Secondary|Mean Change From Baseline to Endpoint From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to endpoint. Higher (positive) scores indicate worsening.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
777764|NCT00772005|Secondary|Mean Change From Baseline to Week 24 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in patients with schizophrenia. The positive symptoms dimension is sum of 4 positive symptoms (delusions, hallucinatory behavior, grandiosity, suspiciousness/persecution), 1 negative symptom (stereotyped thinking), and 3 general psychopathology symptoms (somatic concern, unusual thought content, lack of judgment/insight). Each item is scored on a 7-point scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 8 to 56. Higher (positive) scores indicate worsening. Data show change from baseline to week 24.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
777765|NCT00772005|Secondary|Mean Change From Baseline to Week 20 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in patients with schizophrenia. The positive symptoms dimension is sum of 4 positive symptoms (delusions, hallucinatory behavior, grandiosity, suspiciousness/persecution), 1 negative symptom (stereotyped thinking), and 3 general psychopathology symptoms (somatic concern, unusual thought content, lack of judgment/insight). Each item is scored on a 7-point scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 8 to 56. Higher (positive) scores indicate worsening. Data show change from baseline to week 20.|Baseline and Week 20|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
777766|NCT00772005|Secondary|Mean Change From Baseline to Week 16 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in patients with schizophrenia. The positive symptoms dimension is sum of 4 positive symptoms (delusions, hallucinatory behavior, grandiosity, suspiciousness/persecution), 1 negative symptom (stereotyped thinking), and 3 general psychopathology symptoms (somatic concern, unusual thought content, lack of judgment/insight). Each item is scored on a 7-point scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 8 to 56. Higher (positive) scores indicate worsening. Data show change from baseline to week 16.|Baseline and Week 16|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
777767|NCT00772005|Secondary|Mean Change From Baseline to Week 12 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in patients with schizophrenia. The positive symptoms dimension is sum of 4 positive symptoms (delusions, hallucinatory behavior, grandiosity, suspiciousness/persecution), 1 negative symptom (stereotyped thinking), and 3 general psychopathology symptoms (somatic concern, unusual thought content, lack of judgment/insight). Each item is scored on a 7-point scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 8 to 56. Higher (positive) scores indicate worsening. Data show change from baseline to week 12.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
777768|NCT00772005|Secondary|Mean Change From Baseline to Week 8 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in patients with schizophrenia. The positive symptoms dimension is sum of 4 positive symptoms (delusions, hallucinatory behavior, grandiosity, suspiciousness/persecution), 1 negative symptom (stereotyped thinking), and 3 general psychopathology symptoms (somatic concern, unusual thought content, lack of judgment/insight). Each item is scored on a 7-point scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 8 to 56. Higher (positive) scores indicate worsening. Data show change from baseline to week 8.|Baseline and Week 8|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
777769|NCT00772005|Secondary|Mean Change From Baseline to Week 4 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in patients with schizophrenia. The positive symptoms dimension is sum of 4 positive symptoms (delusions, hallucinatory behavior, grandiosity, suspiciousness/persecution), 1 negative symptom (stereotyped thinking), and 3 general psychopathology symptoms (somatic concern, unusual thought content, lack of judgment/insight). Each item is scored on a 7-point scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 8 to 56. Higher (positive) scores indicate worsening. Data show change from baseline to week 4.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
777823|NCT00772031|Secondary|Number of Subjects Experiencing at Least a 50% Reduction in 28-day Moderate to Severe Headache Days||6 months|All participants with the opportunity for 6-month follow-up. Due to early study termination some participants were randomized and did not have the opportunity to be followed for six months||participants|||Number
777770|NCT00772005|Secondary|Mean Change From Baseline to Week 2 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in patients with schizophrenia. The positive symptoms dimension is sum of 4 positive symptoms (delusions, hallucinatory behavior, grandiosity, suspiciousness/persecution), 1 negative symptom (stereotyped thinking), and 3 general psychopathology symptoms (somatic concern, unusual thought content, lack of judgment/insight). Each item is scored on a 7-point scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 8 to 56. Higher (positive) scores indicate worsening. Data show change from baseline to week 2.|Baseline and Week 2|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
777771|NCT00772005|Secondary|Mean Change From Baseline to Week 1 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in patients with schizophrenia. Positive symptoms dimension is the sum of 4 positive symptoms (delusions, hallucinatory behavior, grandiosity, suspiciousness/persecution), 1 negative symptom (stereotyped thinking), and 3 general psychopathology symptoms (somatic concern, unusual thought content, lack of judgment/insight). Each item is scored on a 7-point scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 8 to 56. Higher (positive) scores indicate worsening. Data show change from baseline to week 1.|Baseline and Week 1|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
777772|NCT00772005|Secondary|Mean Change From Baseline to Endpoint of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in patients with schizophrenia. The positive symptoms dimension is the sum of 4 positive symptoms (delusions, hallucinatory behavior, grandiosity, suspiciousness/persecution), 1 negative symptom (stereotyped thinking), and 3 general psychopathology symptoms (somatic concern, unusual thought content, lack of judgment/insight). Each item scored on 7-point scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 8 to 56. Higher (positive) scores indicate worsening. Data show change from baseline to endpoint.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
777773|NCT00772005|Secondary|Mean Change From Baseline to Week 24 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)|PANSS rates the severity of psychopathology in patients with schizophrenia. The negative symptoms factor score includes 5 negative symptoms (blunted affect, emotional withdrawal, poor rapport, positive/apathetic social withdrawal, lack of spontaneity) and 2 general psychopathology symptoms (motor retardation, active social avoidance). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 7 to 49. Higher (positive) score indicates worsening. Data represents change from baseline to week 24.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
777774|NCT00772005|Secondary|Mean Change From Baseline to Week 20 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)|PANSS rates the severity of psychopathology in patients with schizophrenia. The negative symptoms factor score includes 5 negative symptoms (blunted affect, emotional withdrawal, poor rapport, positive/apathetic social withdrawal, lack of spontaneity) and 2 general psychopathology symptoms (motor retardation, active social avoidance). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 7 to 49. Higher (positive) score indicates worsening. Data represents change from baseline to week 20.|Baseline and Week 20|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
777775|NCT00772005|Secondary|Mean Change From Baseline to Week 16 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)|PANSS rates the severity of psychopathology in patients with schizophrenia. The negative symptoms factor score includes 5 negative symptoms (blunted affect, emotional withdrawal, poor rapport, positive/apathetic social withdrawal, lack of spontaneity) and 2 general psychopathology symptoms (motor retardation, active social avoidance). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 7 to 49. Higher (positive) score indicates worsening. Data represents change from baseline to week 16.|Baseline and Week 16|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
777776|NCT00772005|Secondary|Mean Change From Baseline to Week 12 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)|PANSS rates the severity of psychopathology in patients with schizophrenia. The negative symptoms factor score includes 5 negative symptoms (blunted affect, emotional withdrawal, poor rapport, positive/apathetic social withdrawal, lack of spontaneity) and 2 general psychopathology symptoms (motor retardation, active social avoidance). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 7 to 49. Higher (positive) score indicates worsening. Data represents change from baseline to week 12.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
777777|NCT00772005|Secondary|Mean Change From Baseline to Week 8 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)|PANSS rates the severity of psychopathology in patients with schizophrenia. The negative symptoms factor score includes 5 negative symptoms (blunted affect, emotional withdrawal, poor rapport, positive/apathetic social withdrawal, lack of spontaneity) and 2 general psychopathology symptoms (motor retardation, active social avoidance). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 7 to 49. Higher (positive) score indicates worsening. Data represents change from baseline to week 8.|Baseline and Week 8|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
780365|NCT00802880|Secondary|Rate of Neutropenia (Grade 3/4)|"Grade 3 neutropenia = absolute neutrophil count of <1000 – 500/mm^3
Grade 4 neutropenia = absolute neutrophil count of <500/mm^3"|Completion of 6 cycles of treatment (18 weeks)|||percentage of participants|||Number
777778|NCT00772005|Secondary|Mean Change From Baseline to Week 4 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)|PANSS rates the severity of psychopathology in patients with schizophrenia. The negative symptoms factor score includes 5 negative symptoms (blunted affect, emotional withdrawal, poor rapport, positive/apathetic social withdrawal, lack of spontaneity) and 2 general psychopathology symptoms (motor retardation, active social avoidance). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 7 to 49. Higher (positive) score indicates worsening. Data represents change from baseline to week 4.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
777779|NCT00772005|Secondary|Mean Change From Baseline to Week 2 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)|PANSS rates the severity of psychopathology in patients with schizophrenia. The negative symptoms factor score includes 5 negative symptoms (blunted affect, emotional withdrawal, poor rapport, positive/apathetic social withdrawal, lack of spontaneity) and 2 general psychopathology symptoms (motor retardation, active social avoidance). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 7 to 49. Higher (positive) score indicates worsening. Data represents change from baseline to week 2.|Baseline and Week 2|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
777780|NCT00772005|Secondary|Mean Change From Baseline to Week 1 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)|PANSS rates the severity of psychopathology in patients with schizophrenia. The negative symptoms factor score includes 5 negative symptoms (blunted affect, emotional withdrawal, poor rapport, positive/apathetic social withdrawal, lack of spontaneity) and 2 general psychopathology symptoms (motor retardation, active social avoidance). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 7 to 49. Higher (positive) score indicates worsening. Data represents change from baseline to week 1.|Baseline and Week 1|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
777781|NCT00772005|Secondary|Mean Change From Baseline to Endpoint From Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)|PANSS rates the severity of psychopathology in patients with schizophrenia. The negative symptoms factor score includes 5 negative symptoms (blunted affect, emotional withdrawal, poor rapport, positive/apathetic social withdrawal, lack of spontaneity) and 2 general psychopathology symptoms (motor retardation, active social avoidance). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 7 to 49. Higher (positive) score indicates worsening. Data represents change from baseline to endpoint.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
777782|NCT00772005|Secondary|Mean Change From Baseline to Week 24 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score|PANSS rates psychopathology severity in schizophrenics. 16 items form a General Psychopathology scale:somatic concern, anxiety, guilt feeling, tension, mannerisms/posturing, depression, motor retardation, uncooperative, unusual thoughts, disorientation, poor attention, poor judgment/insight, disturbance of volition, poor impulse control, preoccupation, social avoidance. Scored on severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 16 to 112, higher (positive) score more severe pathology. Data show change from baseline to week 24.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
777783|NCT00772005|Secondary|Mean Change From Baseline to Week 20 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score|PANSS rates psychopathology severity in schizophrenics. 16 items form a General Psychopathology scale:somatic concern, anxiety, guilt feeling, tension, mannerisms/posturing, depression, motor retardation, uncooperative, unusual thoughts, disorientation, poor attention, poor judgment/insight, disturbance of volition, poor impulse control, preoccupation, social avoidance. Scored on severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 16 to 112, higher (positive) score more severe pathology. Data show change from baseline to week 20.|Baseline and Week 20|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
777784|NCT00772005|Secondary|Mean Change From Baseline to Week 16 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score|PANSS rates psychopathology severity in schizophrenics. 16 items form a General Psychopathology scale:somatic concern, anxiety, guilt feeling, tension, mannerisms/posturing, depression, motor retardation, uncooperative, unusual thoughts, disorientation, poor attention, poor judgment/insight, disturbance of volition, poor impulse control, preoccupation, social avoidance. Scored on severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 16 to 112, higher (positive) score more severe pathology. Data show change from baseline to week 16.|Baseline and Week 16|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
777785|NCT00772005|Secondary|Mean Change From Baseline to Week 12 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score|PANSS rates psychopathology severity in schizophrenics. 16 items form a General Psychopathology scale:somatic concern, anxiety, guilt feeling, tension, mannerisms/posturing, depression, motor retardation, uncooperative, unusual thoughts, disorientation, poor attention, poor judgment/insight, disturbance of volition, poor impulse control, preoccupation, social avoidance. Scored on severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 16 to 112, higher (positive) score more severe pathology. Data show change from baseline to week 12.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
789863|NCT00868517|Secondary|Hypnotic Medication Use|Amount of sleep medication taken by study participants. Measured by looking at demographic questionnaire results, chart reviews and Morin sleep diary (MSD).|t=2 months|||participants|||Number
777786|NCT00772005|Secondary|Mean Change From Baseline to Week 8 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score|PANSS rates psychopathology severity in schizophrenics. 16 items form a General Psychopathology scale:somatic concern, anxiety, guilt feeling, tension, mannerisms/posturing, depression, motor retardation, uncooperative, unusual thoughts, disorientation, poor attention, poor judgment/insight, disturbance of volition, poor impulse control, preoccupation, social avoidance. Scored on severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 16 to 112, higher (positive) score more severe pathology. Data show change from baseline to week 8.|Baseline and Week 8|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
777787|NCT00772005|Secondary|Mean Change From Baseline to Week 4 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score|PANSS rates psychopathology severity in schizophrenics. 16 items form a General Psychopathology scale:somatic concern, anxiety, guilt feeling, tension, mannerisms/posturing, depression, motor retardation, uncooperative, unusual thoughts, disorientation, poor attention, poor judgment/insight, disturbance of volition, poor impulse control, preoccupation, social avoidance. Scored on severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 16 to 112, higher (positive) score more severe pathology. Data show change from baseline to week 4.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
777788|NCT00772005|Secondary|Mean Change From Baseline to Week 2 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score|PANSS rates psychopathology severity in schizophrenics. 16 items form a General Psychopathology scale:somatic concern, anxiety, guilt feeling, tension, mannerisms/posturing, depression, motor retardation, uncooperative, unusual thoughts, disorientation, poor attention, poor judgment/insight, disturbance of volition, poor impulse control, preoccupation, social avoidance. Scored on severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 16 to 112, higher (positive) score more severe pathology. Data show change from baseline to week 2.|Baseline and Week 2|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
777789|NCT00772005|Secondary|Mean Change From Baseline to Week 1 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score|PANSS rates psychopathology severity in schizophrenics. 16 items form a General Psychopathology scale:somatic concern, anxiety, guilt feeling, tension, mannerisms/posturing, depression, motor retardation, uncooperative, unusual thoughts, disorientation, poor attention, poor judgment/insight, disturbance of volition, poor impulse control, preoccupation, social avoidance. Scored on severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 16 to 112, higher (positive) score more severe pathology. Data show change from baseline to week 1.|Baseline and Week 1|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
777790|NCT00772005|Secondary|Mean Change From Baseline to Endpoint on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score|PANSS rates psychopathology severity in schizophrenics. 16 items form a General Psychopathology scale:somatic concern, anxiety, guilt feeling, tension, mannerisms/posturing, depression, motor retardation, uncooperative, unusual thoughts, disorientation, poor attention, poor judgment/insight, disturbance of volition, poor impulse control, preoccupation, social avoidance. Scored on severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 16 to 112, higher (positive) score more severe pathology. Data shows change from baseline to endpoint.|Baseline and Endpoint (Week 24 or last observation after baseline)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
777791|NCT00772005|Secondary|Mean Change From Baseline to Week 24 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 24. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Deviation|Mean
777792|NCT00772005|Secondary|Mean Change From Baseline to Week 20 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 20. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology.|Baseline and Week 20|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Deviation|Mean
777793|NCT00772005|Secondary|Mean Change From Baseline to Week 16 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 16. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology.|Baseline and Week 16|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Deviation|Mean
779016|NCT00786565|Secondary|High Contrast Visual Acuity|High contrast visual acuity (ability to distinguish objects of contrasting color such as black on white) uncorrected and best corrected visual acuity.|1 month|Patients without missing values for HCVA logmar at pre-operative and post operative at 1 month control.||LogMAR||Standard Deviation|Mean
777794|NCT00772005|Secondary|Mean Change From Baseline to Week 12 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 12. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Deviation|Mean
777795|NCT00772005|Secondary|Mean Change From Baseline to Week 8 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 8. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology.|Baseline and Week 8|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Deviation|Mean
777796|NCT00772005|Secondary|Mean Change From Baseline to Week 4 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 4. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Deviation|Mean
777797|NCT00772005|Secondary|Mean Change From Baseline to Week 2 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 2. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology.|Baseline and Week 2|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Deviation|Mean
777798|NCT00772005|Secondary|Mean Change From Baseline to Week 1 in the Positive and Negative Syndrome Scale (PANSS)Positive Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 1. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology.|Baseline and Week 1|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Deviation|Mean
777799|NCT00772005|Secondary|Mean Change From Baseline to Endpoint in the Positive and Negative Syndrome Scale(PANSS) Positive Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to endpoint. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Deviation|Mean
777800|NCT00772005|Secondary|Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 24|PANSS rates the severity of psychopathology in schizophrenics. 7 items measure negative symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Data represents change in Negative Rating Scale from baseline to week 24. Negative Scale score ranges from 7 to 49, higher (positive) score indicates more severe pathology.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
777801|NCT00772005|Secondary|Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 20|PANSS rates the severity of psychopathology in schizophrenics. 7 items measure negative symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Data represents change in Negative Rating Scale from baseline to week 20. Negative Scale score ranges from 7 to 49, higher (positive) score indicates more severe pathology.|Baseline and Week 20|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
777824|NCT00772031|Secondary|Number of Subjects Experiencing at Least a 30% Reduction in 28-day Moderate to Severe Headache Days||6 months post randomization|All subjects randomized with opportunity for 6 month followup. Due to early study termination those who did not have opportunity for 6 month followup at time of study closure were excluded. All lost to followups were counted as failure||participants|||Number
777802|NCT00772005|Secondary|Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 16|PANSS rates the severity of psychopathology in schizophrenics. 7 items measure negative symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Data represents change in Negative Rating Scale from baseline to week 16. Negative Scale score ranges from 7 to 49, higher (positive) score indicates more severe pathology.|Baseline and Week 16|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
777803|NCT00772005|Secondary|Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 12|PANSS rates the severity of psychopathology in schizophrenics. 7 items measure negative symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Data represents change in Negative Rating Scale from baseline to week 12. Negative Scale score ranges from 7 to 49, higher (positive) score indicates more severe pathology.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
777804|NCT00772005|Secondary|Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 8|PANSS rates the severity of psychopathology in schizophrenics. 7 items measure negative symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Data represents change in Negative Rating Scale from baseline to week 8. Negative Scale score ranges from 7 to 49, higher (positive) score indicates more severe pathology.|Baseline and Week 8|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
777805|NCT00772005|Secondary|Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 4|PANSS rates the severity of psychopathology in schizophrenics. 7 items measure negative symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Data represents change in Negative Rating Scale from baseline to week 4. Negative Scale score ranges from 7 to 49, higher (positive) score indicates more severe pathology.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
777806|NCT00772005|Secondary|Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 2|PANSS rates the severity of psychopathology in schizophrenics. 7 items measure negative symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Data represents change in Negative Rating Scale from baseline to week 2. Negative Scale score ranges from 7 to 49, higher (positive) score indicates more severe pathology.|Baseline and Week 2|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
777807|NCT00772005|Secondary|Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 1|PANSS rates the severity of psychopathology in schizophrenics. 7 items measure negative symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Data represents change in Negative Rating Scale from baseline to week 1. Negative Scale score ranges from 7 to 49, higher (positive) score indicates more severe pathology.|Baseline and Week 1|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
777808|NCT00772005|Secondary|Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 24|PANSS is a clinician rating severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. Data represent the change in total score from baseline to week 24, higher (positive) scores indicate more severe pathology.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
777809|NCT00772005|Secondary|Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 20|PANSS is a clinician rating severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. Data represents the change in total score from baseline to week 20, higher (positive) scores indicate more severe pathology.|Baseline and Week 20|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
777979|NCT00773461|Secondary|Change in Participant's Global Assessment of Pain From Baseline to Week 24|The participants assessed their pain on a 0 to 100 mm VAS. The left-hand extreme of the line equals 0 mm, and is described as “no pain” and the right-hand extreme equals 100 mm as “unbearable pain”. A negative change indicated improvement.|Baseline and Week 24|ITT Population||mm||Standard Deviation|Mean
777810|NCT00772005|Secondary|Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 16|PANSS is a clinician rating severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. Data represent the change in total score from baseline to week 16, higher (positive) scores indicate more severe pathology.|Baseline and Week 16|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
777811|NCT00772005|Secondary|Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 12|PANSS is a clinician rating severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. Data represents the change in total score from baseline to week 12, higher (positive) scores indicate more severe pathology.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
777812|NCT00772005|Secondary|Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 8|PANSS is a clinician rating severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. Data represents the change in total score from baseline to week 8, higher (positive) scores indicate more severe pathology.|Baseline and Week 8|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
777813|NCT00772005|Secondary|Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 4|PANSS is a clinician rating severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. Data represents the change in total score from baseline to week 4, higher (positive) scores indicate more severe pathology.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
777814|NCT00772005|Secondary|Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 2|PANSS is a clinician rating severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. Data represents the change in total score from baseline to week 2, higher (positive) scores indicate more severe pathology.|Baseline and Week 2|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
777815|NCT00772005|Secondary|Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 1|PANSS rates severity of psychopathology in schizophrenics. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg.anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. The data here represents the change in total score from baseline to week 1 and higher (positive) scores indicate more severe pathology.|Baseline and Week 1|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
777816|NCT00772005|Secondary|Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Endpoint|PANSS is a clinician rating severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. Data represents change in total score from baseline to endpoint, higher (positive) scores indicate more severe pathology.|Baseline and Endpoint (Week 24 or last observation after baseline)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Error|Least Squares Mean
777817|NCT00772005|Primary|Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Endpoint|PANSS rates severity of psychopathology in schizophrenics. 7 items measure NEGATIVE symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Negative Scale score ranges from 7-49 (higher more severe). Data represents change in Negative Rating Scale from baseline to endpoint with positive scores indicating more severe pathology.|Baseline and Endpoint (Week 24 or last observation after baseline)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
779174|NCT00778817|Secondary|Number of Patients Exhibiting Decrease in Tumor Size at 12 Weeks|Total number of patients whose tumor size at 12 weeks was smaller than their tumor size recorded at baseline (by any amount).|12 weeks|The analysis population excludes two patients who withdrew from the study before the 6 week assessment.||participants|||Number
777825|NCT00772031|Primary|Change in the Number of Moderate to Severe Headache Days Within a 28 Day Average Period in Six Months Compared to Baseline|(Number of moderate to severe headache days (as defined by the International Headache Society Guidelines (2006)) counted over a 28 day diary period at baseline (before treatment with propranolol or placebo)) minus (the number of moderate to severe headache days counted over a 56 day diary period (weeks 16-24 post treatment) divided by 2).|Baseline (pre-randomization), months 5 and 6 post randomization|ITT to the extent diary information was available. Available defined as all subjects with 12 or more diary entries between 16 and 24 weeks. Multiple imputation used on all randomized subjects as a sensitivity analysis on the primary outcome.||Moderate to severe headache days||Standard Deviation|Mean
777826|NCT00772070|Primary|Geometric Mean Titers (GMT) of Serum Bactericidal Activity for Each Vaccine Serogroups Before and Post-vaccination.||Day 0 and Days 8 and 28 post-vaccination|Geometric mean titers were determined in the per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
777827|NCT00772070|Other Pre-specified|Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination.||Day 0 to 7 post-vaccination|Safety analysis was on all enrolled and vaccinated subjects with available reaction data, intent-to-treat population.||Percentage of participants|||Number
777828|NCT00772070|Other Pre-specified|Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Activity to Each Vaccine Meningococcal Serogroups.||Baseline to Day 8 and Day 28 post-vaccination|Fold rise analysis was assessed in per-protocol population with valid serology data.||Percentage of participants|||Number
777829|NCT00772109|Secondary|Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine|Solicited injection site reactions: Ecchymosis, Erythema, Induration, Pain, Pruritus, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering.|Day 0 up to 7 Days post vaccination|Safety analysis was on all enrolled and vaccinated participants, intend-to-treat population||Participants|||Number
777830|NCT00772109|Secondary|Percentage of Participants Who Achieved Seroprotection Pre- and Post-vaccination With Either Fluzone ID or Fluzone IM|"The serological determinations of anti influenza antibodies was by Hemagglutination Inhibition (HAI) assay.
Seroprotection was defined as a HAI antibody titer ≥ 1:40."|Before and 28 Days post-vaccination|4-Fold increase in antibody levels were analyzed in h per-protocol population||Percentage of Participants|||Number
777831|NCT00772109|Primary|Percentage of Participants Who Achieved Seroconversion Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine|"The serological determinations of anti influenza antibodies was by Hemagglutination Inhibition (HAI) assay.
Seroconversion was defined as either a pre-vaccination HAI titer < 1:10 and post-vaccination titer of ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum of four-fold increase 28 days post-vaccination."|28 Days post-vaccination|Seroprotection was analyzed in the per-protocol population||Percentage of Participants|||Number
777832|NCT00772109|Primary|Geometric Mean Titers (GMTs) at Baseline and Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccines|The serological determinations of anti influenza antibodies was by Hemagglutination Inhibition (HAI) assay|Baseline (Day 0) and 28 Days post-vaccination|Geometric Mean Titers (GMTs) were analyzed in the per-protocol population||Titer||95% Confidence Interval|Geometric Mean
777833|NCT00772148|Primary|Percentage of Patients in Each Treatment Group Achieving Sufficient Tacrolimus Whole Blood Trough Levels (5 to 20 ng/mL) During the First 14 Days Post-transplantation.|Percentage of patients with trough levels within the therapeutic range of 5 to 20 ng/mL was assessed during the initial 14 days (on days 1, 7 and 14) after liver transplant and compared between the two treatment groups.|14 days|Percentage of patients achieving therapeutic tacrolimus trough levels on Day 1, Day 7 and Day 14.||percentage of patients|||Number
777834|NCT00772148|Primary|Percentage of Patients in Each Treatment Group Achieving Sufficient Tacrolimus Whole Blood Trough Levels (5 to 20 ng/mL) During the First 14 Days Post-transplantation.|Percentage of patients with trough levels within the therapeutic range of 5 to 20 ng/mL was assessed during the initial 14 days (on days 1, 7 and 14) after liver transplant and compared between the two treatment groups.|7 days|Percentage of patients achieving therapeutic tacrolimus trough levels on Day 1, Day 7 and Day 14.||percentage of patients|||Number
777835|NCT00772148|Primary|Percentage of Patients in Each Treatment Group Achieving Sufficient Tacrolimus Whole Blood Trough Levels (5 to 20 ng/mL) During the First 14 Days Post-transplantation.|Percentage of patients with trough levels within the therapeutic range of 5 to 20 ng/mL was assessed during the initial 14 days (on days 1, 7 and 14) after liver transplant and compared between the two treatment groups.|1 day|Percentage of patients achieving therapeutic tacrolimus trough levels on Day 1, Day 7 and Day 14.||percentage of patients|||Number
777836|NCT00772148|Primary|Pharmacokinetics (AUC0-24) of LCP-Tacro™ Compared to Prograf Early After Transplantations (Within the First 14 Days) in Adult de Novo Liver Transplant Recipients.|The pharmacokinetic parameter (AUC, 0 to 24 hours post dose) was evaluated during the first 14 days after liver transplant (on days 1, 7 and 14). The results for Day 14 is listed below as the primary outcome parameter for this study.|14 days|Arithmetic mean of the Pharmacokinetic parameters on Day 14 (mITT population)||ng/mL*hr||Standard Deviation|Mean
777837|NCT00772148|Secondary|Number of Participants Who Died Within the 360 Days.|Number of patients who died was compared between the two groups during the study.|360 days|||participants|||Number
777838|NCT00772148|Primary|Pharmacokinetics (Cmax and Cmin) of LCP-Tacro™ Compared to Prograf Early After Transplantations (Within the First 14 Days) in Adult de Novo Liver Transplant Recipients.|The pharmacokinetic parameters (Cmax and Cmin) were evaluated during the first 14 days after liver transplant (on days 1, 7 and 14). The results for Day 14 is listed below as the primary outcome parameter for this study.|14 days|Arithmetic mean of the Pharmacokinetic parameters on Day 14 (mITT population)||ng/mL||Standard Deviation|Mean
777852|NCT00772538|Secondary|Number of Asthma Exacerbations Per Patient During the 48-week Treatment Period.|Asthma exacerbations (including severe, non-severe; symptomatic, asymptomatic) were pre-defined as an episode of progressive increase in 1 or more asthma symptoms (e.g. shortness of breath, cough, wheezing, chest tightness or some combination of these symptoms). Additionally, decrease of patients best PEF a.m. of 30 percent or more from the patients mean PEF a.m. for at least 2 consecutive days was considered to be an objective marker of asthma exacerbation.|48 weeks|All patients from FAS..||Participants|||Number
777839|NCT00772538|Post-Hoc|The Responder Rate as Assessed by the ACQ From the Two Twin Trials 205.417 (NCT00776984) and the Present 205.416 (NCT00772538)|"The responder rate as assessed by the Asthma Control Questionnaire (ACQ) determined at 24-weeks and 48-weeks (on combined data from the two twin trials 205.416 (NCT00772538) and 205.417 (NCT00776984)). A patient was considered to be a responder if he or she was reported with an improvement (decrease) in the ACQ total score of at least 0.5 points.
The ACQ total score was calculated as the mean of the responses to 7 questions and was analysed as an absolute value. The score ranges from 0 (no impairment) to 6 (maximum impairment).
This outcome definition is taken from the primary outcome definition for the twin trials 205.418 (NCT01172808) and 205.419 (NCT01172821) of the same development program."|24 weeks, 48 weeks|FAS of combined data from the two twin trials 205.416 (NCT00772538) and 205.417 (NCT00776984)||percentage of participants|||Number
777840|NCT00772538|Secondary|Mean Pro Re Nata (as Needed, PRN) Rescue Medication Use Response During the Last-7-days-before-week-24-visit .|Weekly means obtained during the last 7 days before week 24 visit were compared. The response is defined as the change of the weekly mean from the baseline weekly mean. The use of PRN salbutamol (albuterol rescue medication) is determined by the number of puffs of rescue therapy used per day. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and last 7 days before week 24 visit|All patients from FAS.||Puffs||Standard Error|Mean
777841|NCT00772538|Secondary|Asthma Symptom Free Days Response During the Last-7-days-before-week-24-visit .|Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). The response is defined as the change of the weekly mean from the baseline weekly mean. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and last 7 days before week 24 visit|All patients from FAS.||Days||Standard Error|Mean
777842|NCT00772538|Secondary|ACQ at the End of the 48-week Treatment Period.|For the ACQ, the total score was calculated as the mean of the responses to 7 questions and was analysed as an absolute value. The score ranges from 0 (no impairment) to 6 (maximum impairment). MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|48 weeks|All patients from FAS.||Scores on a scale||Standard Error|Mean
777843|NCT00772538|Secondary|Asthma Control as Assessed by Asthma Control Questionnaire (ACQ) at the End of the 24-week Treatment Period.|For the ACQ, the total score was calculated as the mean of the responses to 7 questions and was analysed as an absolute value. The score ranges from 0 (no impairment) to 6 (maximum impairment). MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|24 weeks|All patients from FAS.||Scores on a scale||Standard Error|Mean
777844|NCT00772538|Secondary|AQLQ(S) Total Score at the End of the 48-week Treatment Period.|The AQLQ(S) total score was calculated as the mean of the responses to 32 questions for the domains Symptoms, Activity Limitations, Emotional Function and Environmental Stimuli and was analysed as an absolute value. The AQLQ(S) total score ranges from 1 (worst controlled) to 7 (best). MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|48 weeks|All patients from FAS.||Scores on a scale||Standard Error|Mean
777845|NCT00772538|Secondary|Quality of Life as Assessed by Standardised Asthma Quality of Life Questionnaire (AQLQ(S)) at the End of the 24-week Treatment Period.|The AQLQ(S) total score was calculated as the mean of the responses to 32 questions for the domains Symptoms, Activity Limitations, Emotional Function and Environmental Stimuli and was analysed as an absolute value. The AQLQ(S) total score ranges from 1 (worst controlled) to 7 (best). MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|24 weeks|All patients from FAS.||Scores on a scale||Standard Error|Mean
777846|NCT00772538|Secondary|Number of Patients With at Least One Hospitalisation for Asthma Exacerbation During the 48-week Treatment Period.||48 weeks|All patients from FAS.||Participants|||Number
777847|NCT00772538|Secondary|Number of Hospitalisations for Asthma Exacerbations Per Patient During the 48-week Treatment Period.||48 weeks|All patients from FAS.||Participants|||Number
777848|NCT00772538|Secondary|Time to First Hospitalisation for Asthma Exacerbation During the 48-week Treatment Period.|Asthma exacerbations (including severe, non-severe; symptomatic, asymptomatic) were pre-defined as an episode of progressive increase in 1 or more asthma symptoms (e.g. shortness of breath, cough, wheezing, chest tightness or some combination of these symptoms). Additionally, decrease of patients best PEF a.m. of 30 percent or more from the patients mean PEF a.m. for at least 2 consecutive days was considered to be an objective marker of asthma exacerbation.|48 weeks|All patients from FAS. As <50percent (10 of 222 patients in the placebo group and 8 of 237 patients in the Tio R5 group) of patients had severe exacerbation, the median time was not calculable.|||||
777849|NCT00772538|Secondary|Number of Patients With at Least One Severe Asthma Exacerbation During the 48-week Treatment Period.|Severe asthma exacerbations were pre-defined as all asthma exacerbations that required treatment with systemic (including oral) corticosteroids for at least 3 days or (in case of ongoing and pre-existing systemic corticosteroid therapy) that required at least a doubling of the previous daily dose of systemic corticosteroids for at least 3 days.|48 weeks|All patients from FAS.||Participants|||Number
777850|NCT00772538|Secondary|Number of Patients With at Least One Asthma Exacerbation During the 48-week Treatment Period.|Asthma exacerbations (including severe, non-severe; symptomatic, asymptomatic) were pre-defined as an episode of progressive increase in 1 or more asthma symptoms (e.g. shortness of breath, cough, wheezing, chest tightness or some combination of these symptoms). Additionally, decrease of patients best PEF a.m. of 30 percent or more from the patients mean PEF a.m. for at least 2 consecutive days was considered to be an objective marker of asthma exacerbation.|48 weeks|All patients from FAS.||Participants|||Number
777851|NCT00772538|Secondary|Number of Severe Asthma Exacerbations Per Patient During the 48-week Treatment Period.|Severe asthma exacerbations were pre-defined as all asthma exacerbations that required treatment with systemic (including oral) corticosteroids for at least 3 days or (in case of ongoing and pre-existing systemic corticosteroid therapy) that required at least a doubling of the previous daily dose of systemic corticosteroids for at least 3 days.|48 weeks|All patients from FAS..||Participants|||Number
777854|NCT00772538|Secondary|Mean PEF Variability Response (Absolute Difference Between Morning and Evening PEF Value Divided by Their Mean) of Last-7-days-before-week 24-visit.|Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). The PEF variability is the absolute difference between morning and evening PEF value divided by their mean, expressed as a percent. Response was defined as change from baseline. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and last 7 days before week 24 visit|All patients from FAS.||Percent||Standard Error|Mean
777855|NCT00772538|Secondary|Mean Pre-dose FEV1-p.m.Response (Diary Data) of Last-7-days-before-week 24-visit.|Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). Response was defined as change from baseline. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and last 7 days before week 24 visit|All patients from FAS.||Liter||Standard Error|Mean
777856|NCT00772538|Secondary|Mean Pre-dose FEV1 a.m. Response (Diary Data) of Last-7-days-before-week 24-visit.|Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). Response was defined as change from baseline. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and last 7 days before week 24 visit|All patients from FAS.||Liter||Standard Error|Mean
777857|NCT00772538|Secondary|Mean Pre-dose Evening Peak Expiratory Flow (PEFp.m.) Response (Diary Data) of Last-7-days-before-week 24-visit.|Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). Response was defined as change from baseline. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and last 7 days before week 24 visit|All patients from FAS.||L/min||Standard Error|Mean
777858|NCT00772538|Secondary|Mean Pre-dose Morning Peak Expiratory Flow (PEFa.m.) Response (Diary Data) of Last-7-days-before-week-24-visit .|Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). Response was defined as change from baseline. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and last 7 days before week 24 visit|All patients from FAS.||L/min||Standard Error|Mean
777859|NCT00772538|Secondary|FVC AUC0-3h Response at the End of the 48-week Treatment Period.|The AUC0-3h was calculated as area under the curve from zero to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. The trough value was assigned to zero time. Response was defined as change from baseline in FVC AUC0-3h after a treatment period of 48 weeks. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit baseline*visit.|Baseline and 48 weeks|All patients from FAS.||Liter||Standard Error|Mean
777860|NCT00772538|Secondary|Trough FVC Response at the End of the 48-week Treatment Period.|The trough FVC is defined as the pre-dose FVC measured 10 minutes before the last administration of randomised treatment. Trough FVC response was defined as the difference between the trough FVC measured after a treatment period of 48 weeks and the FVC baseline measurement. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 48 weeks|All patients from FAS.||Liter||Standard Error|Mean
777861|NCT00772538|Secondary|Peak FVC 0-3h Response at the End of the 48-week Treatment Period.|Peak FVC 0-3h response was defined as the difference between the maximum FVC measured within the first 3 hours post dosing after a treatment period of 48 weeks and the FVC baseline measurement (10 minutes before the first dose of trial medication). MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 48 weeks|All patients from FAS.||Liter||Standard Error|Mean
777862|NCT00772538|Secondary|AUC0-3h FEV1 Response at the End of the 48-week Treatment Period.|The AUC0-3h was calculated as area under the curve from zero to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. The trough value was assigned to zero time. Response was defined as change from baseline in FEV1 AUC0-3h after a treatment period of 48 weeks. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit baseline*visit.|Baseline and 48 weeks|All patients from FAS.||Liter||Standard Error|Mean
777863|NCT00772538|Secondary|Trough FEV1 Response at the End of the 48-week Treatment Period.|The trough FEV1 is defined as the pre-dose FEV1 measured 10 minutes before the last administration of randomised treatment. Trough FEV1 response was defined as the difference between the trough FEV1 measured after a treatment period of 48 weeks and the FEV1 baseline measurement. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 48 weeks|All patients from FAS.||Liter||Standard Error|Mean
777864|NCT00772538|Secondary|Peak FEV1 0-3h Response at the End of the 48-week Treatment Period.|Peak FEV1 0-3h response was defined as the difference between the maximum FEV1 measured within the first 3 hours post dosing after a treatment period of 48 weeks and the FEV1 baseline measurement (10 minutes before the first dose of trial medication). Mixed Model Repeated Measure (MMRM) results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 48 weeks|All patients from FAS.||Liter||Standard Error|Mean
777865|NCT00772538|Secondary|FVC (AUC0-3h) Response at the End of the 24-week Treatment Period.|The AUC0-3h was calculated as area under the curve from zero to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. The trough value was assigned to zero time. Response was defined as change from baseline in FVC AUC0-3h after a treatment period of 24 weeks. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit baseline*visit.|Baseline and 24 weeks|All patients from FAS.||Liter||Standard Error|Mean
777866|NCT00772538|Secondary|FEV1 Area Under the Curve (AUC0-3h) Response at the End of the 24-week Treatment Period.|The AUC0-3h was calculated as area under the curve from zero to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. The trough value was assigned to zero time. Response was defined as change from baseline in FEV1 AUC0-3h after a treatment period of 24 weeks. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit baseline*visit.|Baseline and 24 weeks|All patients from FAS.||Liter||Standard Error|Mean
778593|NCT00782171|Secondary|Implant Survival|Implant survival: An implant was deemed to be surviving, if it was still in place at the time of Evaluation|1 year post-surgery|Number of implants placed. Implants from drop-outs are not included||implants|Number of implants||Number
777869|NCT00772538|Primary|Time to First Severe Asthma Exacerbation During the 48-week Treatment of the Pooled Data From the Two Twin Trials 205.416 (NCT00772538) and the Present 205.417 (NCT00776984).|Severe asthma exacerbations were pre-defined as all asthma exacerbations that required treatment with systemic (including oral) corticosteroids for at least 3 days or (in case of ongoing and pre-existing systemic corticosteroid therapy) that required at least a doubling of the previous daily dose of systemic corticosteroids for at least 3 days.|48 weeks|All patients from FAS of the pooled twin studies 205.416 and 205.417. As <50percent (149 of 454 patients in the placebo group and 122 of 453 patients in the Tio R5 group) of patients had severe exacerbation, the median time was not calculable.||Days||Inter-Quartile Range|Median
777870|NCT00772538|Primary|Trough FEV1 Response Determined After a Treatment Period of 24 Weeks.|The trough FEV1 is defined as the pre-dose FEV1 measured 10 minutes before the last administration of randomised treatment. Trough FEV1 response was defined as the difference between the trough FEV1 measured after a treatment period of 24 weeks and the FEV1 baseline measurement. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 24 weeks|All patients from FAS.||Liter||Standard Error|Mean
777871|NCT00772538|Primary|Peak Forced Expiratory Volume in 1 Second (FEV1) Response Within 3 Hours Post Dosing (0-3h) After a Treatment Period of 24 Weeks.|Peak FEV1 0-3h response was defined as the difference between the maximum FEV1 measured within the first 3 hours post dosing after a treatment period of 24 weeks and the FEV1 baseline measurement (10 minutes before the first dose of trial medication). Mixed Model Repeated Measure (MMRM) results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 24 weeks|All patients from Full Analysis Set (FAS) FAS is defined as all patients in the treated set who have baseline data and at least one on-treatment efficacy value.||Liter||Standard Error|Mean
777872|NCT00772577|Secondary|Change From Baseline in Mean Sitting Pulse Pressure (MSPP)|To compare the change in mean sitting pulse pressure (MSPP) after 8 weeks of treatment with aliskiren HCTZ (150/12.5 mg, 300/25 mg) versus ramipril (5 mg, 10 mg).|Baseline to week 8|Intent-to-treat population (consisted of all patients who received at least one dose of study medication and had at least one valid post baseline assessment of primary efficacy variable). Last Observation Carried Forward (LOCF)||mm Hg||Standard Deviation|Mean
777873|NCT00772577|Secondary|Percentage of Responders (MSSBP < 140 mmHg or ≥ 20 mmHg Decrease From Baseline in MSSBP)|To compare the percentage of responders (as defined by patients with MSSBP < 140 mm Hg or a decrease from baseline ≥ 20 mm Hg) during 8 weeks of treatment with aliskiren HCTZ (150/12.5 mg, 300/25 mg) versus ramipril (5 mg, 10 mg). Data presented are cumulative. Cumulative refers to achieving the response before or at the 8 week visit. If response occurred more than once, only the first occurrence was counted.|8 weeks|Intent-to-treat population (consisted of all patients who received at least one dose of study medication and had at least one valid post baseline assessment of primary efficacy variable).||Percentage of patients|||Number
777874|NCT00772577|Secondary|Percentage of Patients Achieving Blood Pressure Control During 8 Weeks|The percentage of patients achieving the Blood Pressure control (defined as patients achieving a MSSBP < 140 mm Hg and MSDBP < 90 mm Hg) during 8 weeks of treatment with aliskiren HCTZ (150/12.5 mg, 300/25 mg) versus ramipril (5 mg, 10 mg). Data presented are cumulative. Cumulative refers to achieving blood pressure control before or at the 8 week visit. If achieving blood pressure control occurred more than once, only the first occurrence was counted.|8 weeks|Intent-to-treat population (consisted of all patients who received at least one dose of study medication and had at least one valid post baseline assessment of primary efficacy variable).||Percentage of patients|||Number
777875|NCT00772577|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)|To evaluate the difference in mean sitting diastolic blood pressure (MSDBP) after 8 weeks of treatment with aliskiren HCTZ (150/12.5 mg, 300/25 mg) versus ramipril (5 mg, 10 mg).|Baseline to week 8|Intent-to-treat population (consisted of all patients who received at least one dose of study medication and had at least one valid post baseline assessment of primary efficacy variable). Last Observation Carried Forward (LOCF)||mm Hg||Standard Deviation|Mean
777876|NCT00772577|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP)|To assess the change in mean sitting systolic blood pressure (MSSBP) after 8 weeks of treatment with aliskiren HCTZ (150/12.5 mg, 300/25 mg) versus ramipril (5 mg, 10 mg).|Baseline to week 8|Intent-to-treat population (consisted of all patients who received at least one dose of study medication and had at least one valid post baseline assessment of primary efficacy variable). Last Observation Carried Forward (LOCF)||mm Hg||Standard Deviation|Mean
777877|NCT00772590|Primary|Mean Change From Baseline CD4+ Cell Count|Comparison of normalised mean change from baseline CD4+ cell count|24 weeks|intention to treat (ITT) - all randomised patients who commenced randomly assigned therapy and who had at least one on-study visit.||Cells/microlitre||Standard Deviation|Mean
777878|NCT00772603|Secondary|Seizure Free Rate, ITT, (M)|Percent of patients seizure-free during Maintenance, Intent-to-Treat population|At the end of 12 weeks (Maintenance Period)|All safety population subjects with adequate baseline Seizure Diary data (at least three consecutive weeks) and at least one visit during the Titration Period and one visit during the Maintenance Period.||percentage of patients|||Number
777879|NCT00772603|Secondary|Seizure-Free Rates, ITT|Percent of patients seizure-free during Treatment Phase, Intent-to-Treat population|At the end of 16 weeks (4 wks Titration + 12 wks Maintenance)|All safety population subjects with baseline Seizure Diary data and at least one visit during the Treatment Phase (ITT population). Subjects must have had at least 3 consecutive weeks of Seizure Diary data (SDD) in the Baseline Phase and at least 14 consecutive days of SDD after starting study drug.||percentage of patients|||Number
777880|NCT00772603|Secondary|Responder Rate, ITT|Percent of patients with a positive response, defined as a 50% or greater reduction in seizure frequency per 28 days relative to Baseline, Treatment Phase, Intent-to-Treat population|At the end of 16 weeks (4 wks Titration + 12 wks Maintenance)|All safety population subjects with baseline Seizure Diary data and at least one visit during the Treatment Phase (ITT population). Subjects must have had at least 3 consecutive weeks of Seizure Diary data (SDD) in the Baseline Phase and at least 14 consecutive days of SDD after starting study drug.||percentage of patients|||Number
778594|NCT00782171|Secondary|Implant Survival|Implant survival: An implant was deemed to be surviving, if it was still in place at the time of evaluation|20-23 Weeks post-surgery|||implants|Implants||Number
777881|NCT00772603|Secondary|PCH(M)- ITT|Percent change in seizure frequency per 28 days relative to Baseline, Maintenance Period (PCH[M]), Intent-to-Treat population|Change at 12 weeks (Maintenance Period) compared to Baseline|All safety population subjects with adequate baseline Seizure Diary data (at least three consecutive weeks) and at least one visit during the Titration Period and one visit during the Maintenance Period.||percentage of change||95% Confidence Interval|Median
777882|NCT00772603|Primary|PCH(T), ITT|Percent change (PCH) in seizure frequency per 28d relative to Baseline, Treatment Phase (PCH[T]), Intent-to-Treat population.|Change at 16 weeks (4wks Titration + 12 wks Maintenance) compared to Baseline|All safety population subjects with baseline Seizure Diary data and at least one visit during the Treatment Phase (ITT population). Subjects must have had at least 3 consecutive weeks of Seizure Diary data (SDD) in the Baseline Phase and at least 14 consecutive days of SDD after starting study drug.||percentage of change||Full Range|Median
777883|NCT00772629|Primary|Participants With a ≥ 4-fold Rise in Antibody Titers as Measured by Serum Bactericidal Assay (SBA) From Day 0 to Day 28.|Number of participants with a minimum of 4 fold rise in Antibody Titers as Measured SBA to each vaccine meningococcal serogroups from Baseline to Day 28.|Day 28 post-vaccination|SBA-BR to each of the 4 meningococcal serogroups in the vaccine was evaluated in the per-protocol population.||Participants|||Number
777884|NCT00772668|Secondary|Safety and Tolerance to Rituximab, Cyclophosphamide, Bortezomib, and Prednisone||5 years||||||
777885|NCT00772668|Secondary|Overall Survival||5 years||||||
777886|NCT00772668|Secondary|Progression-free Survival as Assessed by RECIST Criteria||5 years||||||
777887|NCT00772668|Primary|Overall Response Rate, According to the International Workshop Criteria (IWC)||5 years||||||
777888|NCT00772707|Primary|Comfort Ratings at 30 Days|"Prior to any ocular assessments at the visit, comfort ratings were collected on a questionnaire using 5-point Likert scale, with 1=Strongly Agree, 1=Agree, 3=Neutral, 4=Disagree, 5=Strongly Disagree. The percentage of participants responding with Strongly Agree or Agree for each question is presented."|30 days|5 participants were excluded from analysis due to discontinuation of contact lens wear (1), treatment during study that might interfere with study outcome (1), and withdrawal (3).||Percentage of Participants|||Number
777889|NCT00772707|Primary|Comfort Ratings at Baseline|"Prior to any ocular assessments at the visit, comfort ratings were collected on a questionnaire using 5-point Likert scale, with 1=Strongly Agree, 1=Agree, 3=Neutral, 4=Disagree, 5=Strongly Disagree. The percentage of participants responding with Strongly Agree or Agree for each question is presented."|Baseline (Day 0)|6 participants were excluded from analysis due to discontinuation of contact lens wear (1), treatment during study that might interfere with study outcome (1), withdrawal (3), and missing responses (1).||Percentage of Participants|||Number
777890|NCT00772772|Secondary|1, 25-OH Vitamin D||after 8 weeks of vitamin D therapy||||||
777891|NCT00772772|Secondary|25-hydroxy Vitamin D (25-OH Vitamin D)|25-OH Vitamin D levels were measured in patients with chronic kidney disease at baseline and after 8 weeks of treatment with Vitamin D3 30000 units weekly.|after 8 weeks of vitamin D therapy|Patients with chronic kidney disease had 25-OH vitamin D levels measured at baseline and after 8 weeks of Vitamin D3 therapy. Analysis was per protocol.||ng/ml||Standard Error|Mean
777892|NCT00772772|Secondary|Nuclear Magnetic Resonance (NMR) Lipoprotein Profile||after 8 weeks of vitamin D therapy||||||
777893|NCT00772772|Secondary|Intestinal Permeability||after 8 weeks of vitamin D therapy||||||
777894|NCT00772772|Secondary|Blood Pressure||after 8 weeks of vitamin D therapy||||||
777895|NCT00772772|Primary|Change in Endotoxin Activity|Endotoxin Activity as measured by the Endotoxin Activity Assay. This measurement was made at baseline and after 8 weeks of therapy with Vitamin D3. The measurement of the assay is unitless. It is not based on an absolute amount of endotoxin, but rather the proportion of the theoretical maximal response of the patient and ranges from 0 (lowest) to 1 (highest).|baseline and 8 weeks|Per protocol. Result is expressed as change in endotoxin activity with therapy||EA units||Standard Deviation|Mean
777896|NCT00772889|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From Day 21 to Day 364|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade and related was an event assessed by the investigator as causally related to the study vaccination.|Day 21-364|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
777897|NCT00772889|Secondary|HI Antibody Seroconversion Factors (SCF)|SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|At Day 21|Analysis was performed on According-to-Protocol (ATP) immunogenicity cohort . The cohort included all evaluable subjects for whom data concerning immunogenicity at were available.||fold increase||95% Confidence Interval|Mean
777898|NCT00772889|Secondary|The Number of Subjects Seroconverted to HI Antibodies|A seroconverted subject was defined as a subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|At Day 21|Analysis was performed on According-to-Protocol (ATP) Immunogenicity cohort. This cohort included all evaluable subjects for whom data concerning immunogenicity were available.||subjects|||Number
777899|NCT00772889|Secondary|The Number of Subjects Seroprotected by HI Antibodies|A seroprotected subject was defined as a subject with a serum HI titer ≥ 1:40 that usually is accepted as indicating protection. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|Day 0-21|Analysis was performed on According-to-Protocol (ATP) Immunogenicity cohort. This cohort included all evaluable subjects for whom data concerning immunogenicity were available.||subjects|||Number
777900|NCT00772889|Secondary|The Number of Subjects Seropositive to HI Antibodies|A seropositive subject was defined as a subject with antibody titer greater than or equal to the cut-off value i.e ≥ 1:10. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|Day 0-21|Analysis was performed on According-to-Protocol (ATP) Immunogenicity cohort. This cohort included all evaluable subjects for whom data concerning immunogenicity were available.||subjects|||Number
777902|NCT00772889|Secondary|Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Diseases Between Day 21 and Day 364|AESI for safety monitoring are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as a symptom that prevented normal activity and related was a general symptom assessed by the investigator as causally related to the study vaccination.|Day 21-364.|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
777903|NCT00772889|Secondary|Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) Between Day 21 and Day 179|For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as a symptom that prevented normal activity and related was a general symptom assessed by the investigator as causally related to the study vaccination.|Day 21-179|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
777904|NCT00772889|Primary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From Day 0 to Day 20|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade and related was an event assessed by the investigator as causally related to the study vaccination.|Day 0-20|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
777905|NCT00772889|Primary|Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Diseases From Day 0 to Day 20|AESI for safety monitoring are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Any was defined as occurrence of any symptom regardless of intensity grade.|Day 0-20|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
777906|NCT00772889|Primary|Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) During Day 0 to Day 20|For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as a symptom that prevented normal activity and related was a general symptom assessed by the investigator as causally related to the study vaccination.|Day 0-20|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
777907|NCT00772889|Primary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade. Grade 3 was defined as an unsolicited symptom that prevented normal activity. Related was an event assessed by the investigator as causally related to the study vaccination.|Day 0-20|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
777908|NCT00772889|Primary|Duration of Solicited General AEs|Duration was defined as number of days with any grade of general symptoms.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.||Days||Full Range|Median
777909|NCT00772889|Primary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs|Any fever was defined as oral temperature ≥38.0 degree centigrade (°C), grade 3 fever was oral temperature ≥ 39.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relationship to the study vaccination, grade 3 was defined as a general symptom that prevented normal activity. Related arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever were defined as general symptoms assessed by the investigator as causally related to the study vaccination.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.||subjects|||Number
777910|NCT00772889|Primary|Duration of Solicited Local AEs|Duration was defined as number of days with any grade of local symptoms.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.||Days||Full Range|Median
777911|NCT00772889|Primary|Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)|Grade 3 ecchymosis, redness and swelling were ≥ 100 millimeters (mm) and grade 3 pain was considerable pain at rest that prevented normal everyday activities. Any was >20 mm for ecchymosis, redness and swelling.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.||subjects|||Number
777912|NCT00772915|Secondary|Adverse Events||Duration on treatment (up to 18 cycles from registration)||||||
777913|NCT00772915|Secondary|Progression-free Survival (PFS)|"PFS was defined as the time from registration to progression or death due to any cause. The median PFS with 95%CI was estimated using the Kaplan Meier method.
Progression was defined as any one or more of the following:An increase of 25% from lowest confirmed response in:
Serum M-component (absolute increase >= 0.5g/dl)
Urine M-component (absolute increase >= 200mg/24hour
Difference between involved and uninvolved Free Light Chain levels (absolute increase >= 10mg/dl
Bone marrow plasma cell percentage (absolute increase of >=10%)"|Time from registration to progression or death (up to 3 years)||||||
777914|NCT00772915|Secondary|Overall Survival (OS)|OS was defined as the time from registration to death of any cause. Participants were followed for a maximum of 3 years from randomization. The median OS with 95% CI was estimated using the Kaplan Meier method|Time from registration to death (up to 3 years)||||||
777915|NCT00772915|Secondary|Overall Response Rate|"Response that was confirmed on 2 consecutive evaluations during treatment
Complete Response(CR): Complete disappearance of M-protein from serum & urine on immunofixation, normalization of Free Light Chain (FLC) ratio & <5% plasma cells in bone marrow (BM)
Very Good Partial Response(VGPR): >=90% reduction in serum M-component; Urine M-Component <100 mg per 24 hours; <=5% plasma cells in BM
Partial Response PR): >= 50% reduction in serum M-Component and/or Urine M-Component >= 90% reduction or <200 mg per 24 hours; or >= 50% decrease in difference between involved and uninvolved FLC levels"|Up to 18 cycles from registration||||||
777916|NCT00772915|Primary|Progression-free Survival Rate at 12 Months|PFS at 12 months is a dichotomized outcome indicating whether or not a participant was progression free (and alive) at 12 months from the date of registration.|12 months from registration|||participants|||Number
777917|NCT00772928|Other Pre-specified|Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™|Solicited local reactions: redness, swelling, and tenderness. Solicited systemic reactions: fever (temperature), irritability post-vaccinal, crying, lethargy, appetite decreased, vomiting, diarrhea, and rash.|0-3 days post- vaccination and entire study period|Analysis was on all enrolled and vaccinated subjects, intend-to-treat population.||Percentage of Participants|||Number
777918|NCT00772928|Primary|Geometric Mean Titers of Antibodies to Pertussis, Diphtheria, Tetanus, Polyribosylribitol Phosphate and Poliovirus Elicited by an Infant Series of Pentacel™ When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®)|Anti-pertussis response include antibodies to Pertussis Toxoid (PT); Filamentous Haemagglutinin (FHA); Fimbriae Types 2 and 3 (FIM) and Pertactin (PRN) antigens.|60 Days Post-dose 3|Geometric mean titer analysis was on the total number of subjects with available serology data from the per-protocol immunogenicity population||All Units||95% Confidence Interval|Geometric Mean
777919|NCT00772928|Primary|Percentage of Participants With 4-fold Rises in Levels of Pentacel™ Vaccine Antibody Titers Post-dose 3 When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®)|Seroconversion was defined as the percentage of subjects with ≥ 4-fold post-dose 3 for anti-pertussis and ≥ 0.15 μg/mL or ≥ 1.0 μg/mL for anti-Polyribosylribitol Phosphate (PRP) responses.|28 to 48 days post-3rd vaccination|Analysis was on the total number of subjects with available serology data from the per-protocol immunogenicity population.||Percentage of Participants|||Number
777920|NCT00772941|Secondary|Number of Participants With Continuous Abstinence Situation by 52 Weeks.|Number of participants with dependence on Varenicline by 52 weeks. Varenicline-dependent Treatment Related Adverse Events are Feeling abnormal, Feeling drunk, Feeling jittery, Disturbance in attention, Dizziness, Memory impairment, Mental impairment, Psychomotor hyperactivity, Sedation, Somnolence, Confusional state, Depersonalisation, Disorientation, Dissociation, Euphoric mood, Mood variable, Mood swings, and Hallucination.|52 weeks|No statistical analysis provided for the frequency of Varenicline-dependent treatment related adverse events.||participants|||Number
777921|NCT00772941|Primary|Number of Unlisted Treatment Related Adverse Events According to Japanese Package Insert.|Adverse events mean all unfavorable events that occur in participants after administration of Varenicline, irrespective of causal relationship to Varenicline (including clinically problematic abnormal changes in laboratory test values). Numbers of Treatment Related Adverse Events were evaluated in company with the causal relationship to Varenicline. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert. The safety was evaluated on the first visit after 24 weeks; however, it was evaluated on the last visit for those who had stopped visiting before 24 weeks.|24 weeks|No statistical analysis provided for the frequency of unlisted treatment related adverse events.||events|||Number
777922|NCT00772941|Primary|Number of Participants With Treatment Related Adverse Events.|Adverse events mean all unfavorable events that occur in participants after administration of Varenicline, irrespective of causal relationship to Varenicline (including clinically problematic abnormal changes in laboratory test values). Treatment related Adverse Events were evaluated in company with the causal relationship to Varenicline. The safety was evaluated on the first visit after 24 weeks; however, it was evaluated on the last visit for those who had stopped visiting before 24 weeks.|24 weeks|No statistical analysis provided for the frequency of treatment related adverse events.||participants|||Number
777923|NCT00772941|Primary|Risk Factors for the Proportion of Responders - Antipsychotics as a Concomitant Drug.|"The primary analysis item was the number of participants succeeding with continuous smoking cessation for the previous 4 weeks/the number of participants for efficacy evaluation excluding drop-out participants."|24 weeks|The efficacy analysis population basically consists of the evaluable participants in accordance with the separately prepared analysis plan (participants judged to have been evaluated appropriately). The number of participants who provided data on concomitant administration of antipsychotics was 2842.||participants|||Number
777924|NCT00772941|Primary|Risk Factors for the Proportion of Responders – Prolonged Administration After 12 Weeks.|"The primary analysis item was the number of participants succeeding with continuous smoking cessation for the previous 4 weeks/the number of participants for efficacy evaluation excluding drop-out participants."|24 weeks|The efficacy analysis population basically consists of the evaluable participants in accordance with the separately prepared analysis plan (participants judged to have been evaluated appropriately). The number of participants in whom the prolonged administration of Varenicline after 12 weeks was confirmed was 2598.||participants|||Number
777925|NCT00772941|Primary|Risk Factors for the Proportion of Responders - Tobacco Consumption Per Day.|"The primary analysis item was the number of participants succeeding with continuous smoking cessation for the previous 4 weeks/the number of participants for efficacy evaluation excluding drop-out participants."|24 weeks|The efficacy analysis population basically consists of the evaluable participants in accordance with the separately prepared analysis plan (participants judged to have been evaluated appropriately). The number of participants who provided data on daily tobacco consumption was 2827.||participants|||Number
777926|NCT00772941|Primary|Risk Factors for the Frequency of Treatment Related Adverse Events - Weight at Baseline.|Number of participants with Treatment Related Adverse Events to determine whether weight at baseline is a significant risk factor.|24 weeks|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed. The number of participants who provided weight data at baseline was 1700.||participants|||Number
777927|NCT00772941|Primary|Risk Factors for the Frequency of Treatment Related Adverse Events – Concomitant Therapies.|Number of participants with Treatment Related Adverse Events of Varenicline to determine whether receiving concomitant therapies is a significant risk factor.|24 weeks|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.||participants|||Number
777928|NCT00772941|Primary|Risk Factors for the Frequency of Treatment Related Adverse Events – Concomitant Drugs.|Number of participants with Treatment Related Adverse Events of Varenicline to determine whether taking concomitant drugs is a significant risk factor.|24 weeks|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.||participants|||Number
777929|NCT00772941|Primary|Risk Factors for the Frequency of Treatment Related Adverse Events - Chronic Obstructive Pulmonary Disease as a Complication.|Number of participants with Treatment Related Adverse Events of Varenicline to determine whether Chronic obstructive pulmonary disease as a complication is a significant risk factor.|24 weeks|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.||participants|||Number
777930|NCT00772941|Primary|Risk Factors for the Frequency of Treatment Related Adverse Events – Age.|Number of participants with Treatment Related Adverse Events of Varenicline to determine whether age is a significant risk factor.|24 weeks|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.||participants|||Number
777931|NCT00772941|Primary|Risk Factors for the Frequency of Treatment Related Adverse Events – Gender.|Number of participants with Treatment Related Adverse Events of Varenicline to determine whether gender is a significant risk factor.|24 weeks|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.||participants|||Number
777932|NCT00772954|Primary|Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine.||Day 0 up to 70 days post first vaccination|Safety assessments were on the safety population.||Participants|||Number
777933|NCT00772967|Secondary|Change From Baseline in Time Weighted Average (TWA) Pain Intensity (PI) on a Numeric Rating Scale (NRS) Due to High-paced Walks on Day 3|Baseline measurements of participant-specific knee PI were gathered pre-dose on Day 1 from the briskest possible self-pace constant walks on a treadmill over the course of a 20 minute interval. Over this interval PI readings were taken at time points 0,3,6,9,12,15,18 and 20 minutes, rated on an 11-point numeric rating scale (NRS), with 0: No Pain – 10: Worst Pain You Can Imagine. Following a single treatment on Day 3, PI was similarly measured over a 20 minute high-paced treadmill walk, at 5 hrs post-dose. A high-paced walk is the highest pace that can be walked safely for at least 5 minutes that is at a 10-30% higher rate than a self-paced walk. The difference between the TWA (0-20 minutes) PI determined at baseline, and the TWA (0-20 minutes) PI of the high-paced walk on Day 3 is reported as units on a scale.|Baseline and Day 3|All treated participants who provided baseline and at least one on-treatment observation||units on a scale||95% Confidence Interval|Least Squares Mean
777934|NCT00772967|Secondary|Change From Baseline in Time Weighted Average (TWA) Pain Intensity (PI) on a Numeric Rating Scale (NRS) Due to High-paced Walks on Day 1|Baseline measurements of participant-specific knee PI were gathered pre-dose on Day 1 from the briskest possible self-pace constant walks on a treadmill over the course of a 20 minute interval. Over this interval PI readings were taken at time points 0,3,6,9,12,15,18 and 20 minutes,rated on an 11-point numeric rating scale (NRS), with 0: No Pain – 10: Worst Pain You Can Imagine. Following the first treatment on Day 1, PI was similarly measured over a 20 minute high-paced treadmill walk at 5 hrs post-dose. A high-paced walk is the highest pace that can be walked safely for at least 5 minutes that is at a 10-30% higher rate than a self-paced walk. The difference between the TWA (0-20 minutes) PI determined at baseline, and the TWA (0-20 minutes) PI of the high-paced walk on Day 1 is reported as units on a scale.|Baseline and Day 1|All treated participants who provided baseline and at least one on-treatment observation||units on a scale||95% Confidence Interval|Least Squares Mean
777935|NCT00772967|Secondary|Change From Baseline in Time Weighted Average (TWA) Pain Intensity (PI) on a Numeric Rating Scale (NRS) Due to Self-paced Walks on Day 1|Baseline measurements of participant-specific knee PI were gathered pre-dose on Day 1 from the briskest possible self-pace constant walks on a treadmill over the course of a 20 minute interval. Over this interval PI readings were taken at time points 0,3,6,9,12,15,18 and 20 minutes, rated on an 11-point numeric rating scale (NRS), with 0: No Pain – 10: Worst Pain You Can Imagine. Following the first treatment on Day 1, PI was similarly measured over 20 minute self-paced walks at 2, 4, and 6 hrs post-dose . The difference between the TWA (0-20 minutes) PI determined at baseline, and the average of the three TWA (0-20 minutes)PI from the self-paced walks on Day 1 is reported as units on a scale.|Baseline and Day 1|All treated participants who provided baseline and at least one on-treatment observation||units on a scale||95% Confidence Interval|Least Squares Mean
777936|NCT00772967|Primary|Change From Baseline in Time Weighted Average (TWA) Pain Intensity (PI) on a Numeric Rating Scale (NRS) Due to Self-paced Walks on Day 3|Baseline measurements of participant-specific knee PI were gathered pre-dose on Day 1 from the briskest possible self-pace constant walks on a treadmill over the course of a 20 minute interval. Over this interval PI readings were taken at time points 0,3,6,9,12,15,18 and 20 minutes, rated on an 11-point numeric rating scale (NRS), with 0: No Pain – 10: Worst Pain You Can Imagine. Following a single treatment on Day 3, PI was similarly measured over 20 minute self paced walks at 4 and 6 hrs post-dose. The difference between the TWA (0-20 minutes) PI determined at baseline, and the average of the two TWA (0-20 minutes) PI from the self-paced walks on Day 3 is reported as units on a scale.|Baseline and Day 3|All treated participants who provided baseline and at least one on-treatment observation||units on a scale||95% Confidence Interval|Least Squares Mean
777937|NCT00773097|Secondary|Number of Participants With Adverse Events Associated With the Study Agent|Laboratory monitoring including Toxicity laboratory test or monitored through out the study up to week 54.|54 weeks|||participants|||Number
777938|NCT00773097|Secondary|Number of Participants With Autoimmune Response to Muc-1 Vaccine|Evaluate for autoimmune response by measuring the Anti-muc-1 IgG antibodies to the muc-1 vaccine.|52 weeks|||participants|||Number
790690|NCT00877929|Secondary|Blood Pressure (BP) Control (SBP<140 mmHg, DBP<90 mmHg) at Eight Weeks|Mean seated SBP<140 mmHg and mean seated DBP<90 mmHg|Baseline, week 8|Treated set using last observation carried forward (LOCF)||participants|||Number
777939|NCT00773097|Primary|Number of Participants With Anti Muc-1 Antibody|Evaluation of the immune response to MUC1 peptide vaccine administered with Poly-ICLC, measured by Anti MUC1 antibody, in patients with a history of advanced colorectal adenoma.|52 weeks|Of the 46 subjects who consented to participate, 6 did not receive vaccine: 4 had abnormal screening laboratory test, 1 did not meet criteria for an advanced adenoma, and 1 declined to participate||participants|||Number
777940|NCT00773136|Primary|Efficacy of Bimatoprost in Lengthening of Eyelashes|Eyelash growth after application of bimatoprost vs control (split face study).|4.5 months (6 weeks of drug application and 3 months after discontinuing)|||mm||Standard Deviation|Mean
777941|NCT00773253|Primary|Mean Percentage Change in Total Toronto Western Spasmodic Torticollis Rating Scale|Mean Percentage change in Toronto Western Spasmodic Torticollis Rating Scale. This scale ranges from 0 (normal) to 85 (very severe).|48 weeks|All participants that completed all phases of the study||percent change in units on the scale||Standard Deviation|Mean
777942|NCT00773253|Primary|Pre- and Post-injection Toronto Western Spasmodic Torticollis Rating Scale(TWSTRS): Global Clinical Impression Scale (GCI); Visual Analog Scale(VAS)||pre-injection, week 16, 20, 36, and 40||||||
777943|NCT00773279|Secondary|Hypoglycaemic Episodes, Number of Events Per Subject Day||Weeks 0-12 (first treatment) and 12-24 (second treatment)|ITT population. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®).||events per subject-day|||Number
777944|NCT00773279|Secondary|Number of Adverse Device Effects|Adverse device effects were defined as clinical technical complaints (CTCs) related to an Adverse Event/Serious Adverse Event. This was defined as an adverse unintended reaction to a medical device. This definition includes any event which is caused by an inadequate or incomplete user instruction or guide in the use of the device and any event caused by wrongful use.|From randomisation (week 0) and until 7 days after Week 24 (Visit 16)|ITT population. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®). Some subjects did not have any available results in PDS290 and FlexPen® treatment groups, respectively.||events|||Number
777945|NCT00773279|Secondary|Number of Hypoglycaemic Episodes|Presented by severity: major: subject not able to treat himself; minor: plasma glucose below 3.1 mmol/L; symptoms only: no plasma glucose measured or above or equal to 3.1 mmol/L.|Weeks 0-12 (first treatment) and 12-24 (second treatment)|ITT population. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®). Some subjects did not have any available results in PDS290 and FlexPen® treatment groups, respectively.||episodes|||Number
777946|NCT00773279|Secondary|Clinical Technical Complaints (CTCs)|A clinical technical complaint is any written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety or performance of a medical device.|Weeks 0-24 (whole trial period)|ITT population. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®). Some subjects did not have any available results in PDS290 and FlexPen® treatment groups, respectively.||CTCs|||Number
777947|NCT00773279|Secondary|Score for Treatment Impact Measure for Diabetes|Treatment Related Impact Measure for Diabetes (TRIM-D and TRIM-D device) with scores from 0-100, higher scores indicate less treatment related impact.|Week 24|ITT population. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®). Some subjects did not have any TRIM-D available results in PDS290 and FlexPen® treatment groups, respectively.||scores on a scale||Standard Deviation|Mean
777948|NCT00773279|Secondary|Summary Score for Treatment Satisfaction|Overall summary from Insulin Treatment Satisfaction Questionnaire (ITSQ) with higher scores (0-100) indicating greater satisfaction.|Week 24|ITT population. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®). Some subjects did not have any available ITSQ results in PDS290 and FlexPen® treatment groups, respectively.||scores on a scale||Standard Deviation|Mean
777949|NCT00773279|Secondary|Percentage of Subject Having Preference for PDS290 Versus FlexPen® in Terms of Convenience and Ease of Use|Questionnaire (Niskanen Comparative Device Questionnaire) compared preference / convenience and ease of use by device specific questionnaire (summarised by scores of question 9)|Week 24|ITT population. Some subjects did not have any available Niskanen Comparative Device Questionnaire results.||percentage of participants|||Number
777950|NCT00773279|Primary|HbA1c (Glycosylated Haemoglobin) for Participants Treated With PDS290 and FlexPen®||Week 12 of each treatment sequence|Intention-to-treat (ITT) population comprising all randomised subjects and with data on HbA1c. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®). Some subjects dropped out during either treatment sequence.||percentage (%) of total haemoglobin||Standard Deviation|Mean
777951|NCT00773370|Secondary|Stroke Impact Scale (SIS)|The SIS Version 3.0 is a self report scale widely used to assess health status after stroke. It includes 59 items and assesses 8 domains (strength, hand function, ADL/IADL, mobility, communication, emotion, memory and thinking, and participation/role function). The SIS uses a 5-point Likert Scale. Summative scores for each domain range from 0-100. Total scores range from 0 to 800. A higher score reflects better function. We computed the slopes (i.e. rates of change from baseline to 3-months and 6-months) using a random effects ANOVA (random intercept and random slope), and determined if the slopes were different using unpaired Student's t-tests.|measured at baseline, 3 months, 6 months|SIS data were incomplete for six sittercise participants, hence the discrepancy between number of participants analyzed and the flow data reported above.||units on a scale||Standard Error|Mean
777980|NCT00773461|Secondary|Change in Physician's Global Assessment of Disease Activity From Baseline to Week 24|The physician’s global assessment of disease activity is assessed on a 0 to 100 mm horizontal VAS by the physician. The left-hand extreme of the line equals 0 mm, and is described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm as “maximum disease activity” (maximum arthritis disease activity).|Baseline and Week 24|ITT Population||mm||Standard Deviation|Mean
777952|NCT00773370|Secondary|Short Physical Performance Battery (SPPB)|The SPPB, which is extensively used in stroke studies, includes three components and a composite score. Components include gait speed, a repeated chair stand, and a standing balance test. Scores for gait speed, chair stand, and total balance are calculated and then summed for the total score. Each component can range from 0-4 points, thus the maximum composite score can range from 0-12 points, with 0 reflecting the lowest functioning while a score of 12 indicates the subject reached the maximum measured competency in all three domains. We computed the slopes (i.e. rates of change from baseline to 3-months and 6-months) using a random effects ANOVA (random intercept and random slope), and determined if the slopes were different using unpaired Student's t-tests.|measured at baseline, 3 months, 6 months|||units on a scale||Standard Error|Mean
777953|NCT00773370|Secondary|Balance as Measured by the Berg Balance Scale (BBS)|The Berg is a widely used test for assessing balance and to predict fall risk in the elderly. It has been validated with patients post stroke. The Berg consists of 14 items, each graded on a scale of 0-4. Thus a score for the Berg could in theory range from a minimum of 0 to a maximum of 56. A score below 45 is indicative of balance impairment; thus the lower the score the greater the fall risk. We computed the slopes (i.e. rates of change from baseline to 3-months and 6-months) using a random effects ANOVA (random intercept and random slope), and determined if the slopes were different using unpaired Student's t-tests.|measured at baseline, 3 months, 6 months|||units on a scale||Standard Error|Mean
777954|NCT00773370|Primary|6 Minute Walk Test (6MWT)|Total distance walked for 6 minutes (in meters) is the primary outcome measure. Participants use the same assistive devices and/or orthoses they use when walking across a parking lot. They are instructed to cover as much distance as they can over a flat 100 foot walking surface demarcated by traffic cones during the six minute time period. Change in distance covered is the outcome variable of interest for this study. Walking a greater distance (e.g. more meters during the 6 minute test) reflects improvement in walking speed and endurance. We computed the slopes (i.e. rates of change from baseline to 3-months and 6-months) using a random effects ANOVA (random intercept and random slope), and determined if the slopes were different using unpaired Student's t-tests.|measured at baseline, 3 months, 6 months|||meters||Standard Error|Mean
777955|NCT00773383|Secondary|Assessment of Potential Predictive and Prognostic Biomarkers.|Total IGF-I, free IGF I/II and other potential biomarkers present in serum. Further putative biomarker analyses in blood and tumor samples were planned in the protocol for exploratory assessment of correlation with clinical outcome. None of these were analyzed due to the termination of the trial.|Throughout study|Responders and non-responders|||||
777956|NCT00773383|Secondary|Population Pharmacokinetics of R1507 and Tarceva|Population PK of R1507 and erlotinib were planned but not analyzed due to the termination of the trial.|Throughout study|Population PK of R1507 and erlotinib|||||
777957|NCT00773383|Secondary|Electrocardiogram (ECG)|12 lead ECG is required at baseline and will be measured during the trial as clinically indicated at the discretion of the investigators. For each reading, QTcF value will be calculated as the QT value (seconds) divided by the cube root of the RR interval in seconds (Fridericia correction). A listing will be generated showing, for each patient, the visits at which ECGs were taken and the results (normal or abnormal, as well as any comments provided).|baseline and thereafter as clinically indicated at the discretion of the investigator up to the time that the patient discontinued (up to 59 weeks)|Safety Population||ms (millisecond)||Standard Deviation|Mean
777958|NCT00773383|Secondary|Number of Participants With Positive Results for Human Anti-human Antibody (HAHA) Testing|"Number of participants who tested positive for Human anti-human antibody (HAHA) testing for immunogenicity.
To determine HAHA specificity, screened positive samples were tested in a confirmatory assay in the presence of 10 ug/mL R1507. Samples with > 19.7% inhibition were considered true positives, whereas those with < 19.7% inhibition were considered to be false positives."|prior to dosing on week 1 (day 1), week 4 (day 22), week 10 (day 64), final visit, follow up visit and 12 weeks post last dose (up to 71 weeks)|Safety Population||participants|||Number
777959|NCT00773383|Secondary|Monthly Urine Pregnancy Test in Female Patients of Childbearing Potential|"Standard safety monitoring includes baseline Electrocardiogram (ECG), Fasting glucose and HbA1c, monthly urine pregnancy test in female patients of childbearing potential and Human anti-human antibody (HAHA) testing.
Not posted; it will be represented in the Serious Adverse Event (SAE) Adverse Event (AE) section of Protocol Registration System (PRS)."|Within 7 days of starting treatment (baseline visit)|Female patients of childbearing potential|||||
777960|NCT00773383|Secondary|Hemoglobin A1c (HbA1c)|"Standard safety monitoring includes baseline Electrocardiogram (ECG), Fasting glucose and HbA1c, monthly urine pregnancy test in female patients of childbearing potential and Human anti-human antibody (HAHA) testing.
Data will be represented in the Serious Adverse Event (SAE) Adverse Event (AE) section of Protocol Registration System (PRS)."|screening|Safety Population|||||
777961|NCT00773383|Secondary|Fasting Glucose, Highest Post-Baseline Value|A fasting glucose was required at baseline, and random non-fasting glucose testing was performed weekly for the first 6 weeks followed by day 1 of each 3 week treatment phase. The number of participants with the highest post-baseline fasting glucose level at any time point post baseline relative to the participant’s baseline glucose level is reported.|Baseline, Highest Post-Baseline value within the timeframe of post-baseline collection up to when patient discontinued (up to 59 weeks)|Safety Population: based on the total number of participants n = 34||participants|||Number
777962|NCT00773383|Secondary|Baseline Electrocardiogram (ECG)|"Standard safety monitoring includes baseline Electrocardiogram (ECG).
The study was prematurely terminated due to discontinuation of R1507 development (not for safety reasons). As a result, data not provided for outcome measures listed. The study was prematurely terminated due to discontinuation of R1507 development (not for safety reasons). As a result, data not provided for outcome measures listed."|baseline within 28 days of starting treatment (screening visit).|Safety Population|||||
777981|NCT00773461|Secondary|Change in Participant's Global Assessment of Disease Activity From Baseline to Week 24|The participant’s global assessment of disease activity is assessed on a 0 to 100 mm horizontal visual analogue scale (VAS) by the participant. The left-hand extreme of the line equals 0 mm, and is described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as “maximum disease activity” (maximum arthritis disease activity). A negative change from Baseline indicated improvement.|Baseline and Week 24|ITT Population||mm||Standard Deviation|Mean
777963|NCT00773383|Secondary|Duration of Objective Response|This is defined similarly for complete and partial responders. Complete response or partial response lasts from the date the complete response or partial response was first recorded to the date on which progressive disease is first noted or date of death. If a patient does not progress or die while being followed, the date of the last valid tumor assessment will be taken. The study was prematurely terminated due to discontinuation of R1507 development (not for safety reasons). As a result, data not provided for outcome measures listed.|from the date the complete or partial response was first recorded to the date which progressive disease is first noted or date of death. If a patient does not progress or die while being followed, the date of the last valid tumor assessment will be taken|All Treated Population|||||
777964|NCT00773383|Secondary|Time to Progressive Disease (PD)|The study was prematurely terminated due to discontinuation of R1507 development (not for safety reasons). As a result, data not provided for outcome measures listed.|From start of therapy to the date of first documentation of PD. Pts who never progress prior to final analysis or are withdrawn from the study without documented progression will be censored at the date of the last valid tumor assessment.|All Treated Population|||||
777965|NCT00773383|Secondary|Time to Best Response|"This is defined as time from the start of therapy to the date of first CR or PR.
The study was prematurely terminated due to discontinuation of R1507 development (not for safety reasons). As a result, data not provided for outcome measures listed."|Patients were followed from start of therapy until date of first response|All Treated Population|||||
777966|NCT00773383|Secondary|Participants Achieving Objective Response|"Objective response is defined as a complete response (CR) or partial response (PR) that has been confirmed by a second tumor assessment no earlier than 4 weeks after the initial documentation. Response is assessed using Response Evaluation Criteria in Solid Tumors (RECIST)criteria.
The study was prematurely terminated due to discontinuation of R1507 development (not for safety reasons). As a result, data not provided for outcome measures listed."|Patients were followed from start of therapy until date of first response|All Treated Population|||||
777967|NCT00773383|Secondary|Duration of Overall Survival|The study was prematurely terminated due to discontinuation of R1507 development (not for safety reasons). As a result, data not provided for outcome measures listed.|From start of treatment to death; up to the time that all participants ended treatment|All Treated Population|||||
777968|NCT00773383|Primary|Percentage of Participants With Progression Free Survival (PFS)|The primary efficacy endpoint is progression-free survival at 12 weeks after start of therapy. A progression-free survival rate at 12 weeks will be calculated, with patients categorized in a dichotomous manner as alive and progression-free or in progression or dead at 12 weeks.|12 weeks|All Treated Population||Percentage of participants|||Number
777969|NCT00773461|Secondary|Time to First Remission|Time to first Remission was calculated as the number of days from the date of first dose of study drug administration to the date of first achievement of DAS<2.6|Weeks 2, 4, 8, 12, 16, 20, and 24|ITT Population||Days||95% Confidence Interval|Median
777970|NCT00773461|Secondary|Time to First Low Disease Activity|Time to Low disease activity was calculated as the number of days from the first dose of drug administration to the date of first achievement of DAS28≤3.2.|Weeks 2, 4, 8, 12, 16, 20, and 24|ITT Population||Days||95% Confidence Interval|Median
777971|NCT00773461|Secondary|Percentage of Participants With ACR20 Response by First Week of Onset|ACR 20 responses are summarized by first onset as a percentage of the total number of responders at week 24. The number of participants first achieving an ACR20 response at each time point is represented by treatment arm as a proportion of the total number of participants that had an ACR20 response at Week 24 using n as the denominator.|Weeks 2, 4, 8, 12, 16, 20, and 24|ITT Population||Percentage of Participants|||Number
777972|NCT00773461|Secondary|Change in Health Assessment Questionnaire - Disease Index (HAQ-DI) From Baseline to Week 24|HAQ-DI is a self-completed participant questionnaire specific for RA. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities. Each domain has at least 2 component questions. There are 4 possible responses for each component 0=without any difficulty 1=with some difficulty 2=with much difficulty 3=unable to do. The HAQ-DI is the sum of the scores, divided by the number of domains that have a score (in range 6-8) for a total possible score minimum/maximum 0 (best) to 3 (worst). A negative change from baseline indicated improvement.|Baseline and 24 Weeks|ITT Population||units on a scale||Standard Deviation|Mean
777973|NCT00773461|Secondary|Change in Hemoglobin From Baseline to Week 24|Levels of hemoglobin were determined in grams/liter (g/L)as a measure of anemia in participants|Baseline and 24 Weeks|ITT Population||g/L||Standard Deviation|Mean
777974|NCT00773461|Secondary|Mean Rheumatoid Factor at Baseline and Week 24|Rheumatoid factor (RF) is a disease characteristic and more than 85% of the participants studied were positive for the factor. These data are from patients who were RF positive. RF level was reported in international units/milliliter (IU/mL). A positive RF= >15 IU/mL.|Baseline and 24 Weeks|ITT Population||IU/mL||Standard Deviation|Mean
777975|NCT00773461|Secondary|Change From Baseline to Week 24 in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score|FACIT-F is a 13-item questionnaire. Patients scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in health status.|Baseline and Week 24|ITT Population||units on a scale||Standard Deviation|Mean
777976|NCT00773461|Secondary|Percentage of Participants With Low Disease Activity and in Clinical Remission|DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, ESR and global health assessment (participant rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. DAS28 less than or equal to (≤3.2) = low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity.|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|ITT Population; n=number of participants analyzed.||Percentage of Participants|||Number
777977|NCT00773461|Secondary|Change in ESR From Baseline to Week 24|The ESR was measured in mm/hour. A reduction in the level is considered an improvement.|Baseline and Week 24|ITT Population||mm/hour||Standard Deviation|Mean
777982|NCT00773461|Secondary|Change in Tender and Swollen Joint Counts From Baseline to Week 24|"68 joints were assessed for tenderness and joints were classified as tender/not tender giving a total possible tender joint count score of 0 to 68.
66 joints were assessed for swelling and joints were classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66."|Baseline and Week 24|ITT Population||Joints||Standard Deviation|Mean
777983|NCT00773461|Secondary|Number of Participants Who Received Escape Therapy|Participants who did not achieve a 20% improvement from baseline in both SJC and TJC at week 16 could, if requested and deemed necessary by the investigator, receive escape therapy, comprising adjustment of the background DMARD dose and/or treatment with a different traditional DMARD.|24 Weeks|ITT Population||Number of participants|||Number
777984|NCT00773461|Secondary|Percentage of Participants With ACR50 and ACR70 Responses at Week 24|To achieve an ACR50 or ACR 70 response required at least a 50% or 70% improvement, compared with baseline in both TJC and SJC, as well as in 3 out of 5 additional ACR core set variables: physician’s global assessment of disease activity, participant’s global assessment of disease activity, participant’s assessment of pain, HAQ-DI and CRP. CRP was used primarily for the calculation of the ACR response; if missing, ESR was substituted.|Week 24|ITT Population||Percentage of Participants|||Number
777985|NCT00773461|Primary|Percentage of Participants With an American College of Rheumatology (ACR)20 Response at Week 24|To achieve an ACR20 response required at least a 20% improvement, compared with baseline, in both (tender joints count)TJC and (swollen joints count) SJC, as well as in 3 out of 5 additional ACR core set variables: physician’s global assessment of disease activity, participant’s global assessment of disease activity, participant’s assessment of pain, health assessment questionnaire disease index (HAQ-DI) and C-reactive protein (CRP). CRP was used primarily for the calculation of the ACR response; if missing, Erythrocyte Sedimentation Rate (ESR) was substituted. ITT sensitivity analysis was carried out using an alternative imputation method (last observation carried forward [LOCF]).|Week 24|ITT Population||Percentage of Participants|||Number
777986|NCT00773474|Secondary|Clinical Benefit Response Rate (Complete Response (CR)+Partial Response(PR)+Stable Disease(SD) > 180 Day Duration).||18 months|20 evaluable subjects were analyzed for Clinical Benefit Rate (CR+PR+SD>180 days per RECIST criteria.||participants|||Number
777987|NCT00773474|Secondary|Toxicity Profile of Lonafarib|To determine the toxicity profile of lonafarnib in this patient population.|18 months|||participants|||Number
777988|NCT00773474|Secondary|Overall Response Rate|To determine overall response rate.|18 months|17 participants were evaluable for Overall Response Rate analysis using RECIST criteria.||participants|||Number
777989|NCT00773474|Primary|Progression Free Survival|To determine progression-free survival of lonafarnib in patients with metastatic breast cancer.|18 months|20 participants were eligible for analysis via the Kaplan-Meier method. PFS assessed via RECIST criteria.||days||95% Confidence Interval|Mean
777990|NCT00773734|Other Pre-specified|LTE Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at 4 Years|The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less severe disease|Week 0 to Month 48|ITT; Participants who entered the long-term extension period||percentage of participants||95% Confidence Interval|Number
777991|NCT00773734|Other Pre-specified|LTE Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at 3 Years|The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less severe disease|Week 0 and month 36|ITT; Participants who entered the long-term extension period||percentage of participants||95% Confidence Interval|Number
777992|NCT00773734|Other Pre-specified|LTE Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at 2 Years|The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less severe disease|Week 0 to Month 24|ITT; Participants who entered the extension period||percentage of participants||95% Confidence Interval|Number
778008|NCT00773734|Secondary|LTE Study: Median Percent Change From Baseline in the Affected Body Surface Area (BSA) at 2 Years|The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant’s hand (entire palmar surface or “handprint”), which equates to approximately 1% of total BSA.|Week 0 to Month 24|Intent to Treat; participants who entered into the LTE period||percent change||Full Range|Median
778009|NCT00773734|Secondary|LTE Study: Median Percent Change From Baseline in the Affected Body Surface Area (BSA) at 18 Months|The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant’s hand (entire palmar surface or “handprint”), which equates to approximately 1% of total BSA.|Week 0 to Month 18|Intent to Treat; participants who entered into the LTE period||percent change||Full Range|Median
777993|NCT00773734|Other Pre-specified|LTE Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at 18 Months|The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less severe disease|Week 0 to Month 18|ITT; Participants who entered the long-term extension period||percentage of participants||95% Confidence Interval|Number
777994|NCT00773734|Secondary|LTE Study: Change From Baseline in the Medical Outcome Study Short Form, SF-36, Version 2; Physical Component Summary Score at 4 Years|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Month 48|ITT; Includes participants who entered the long-term extension period||units on a scale||Standard Deviation|Mean
777995|NCT00773734|Secondary|LTE Study: Change From Baseline in the Medical Outcome Study Short Form, SF-36, Version 2; Physical Component Summary Score at 3 Years|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Month 36|ITT; Includes participants who entered the long-term extension period||units on a scale||Standard Deviation|Mean
777996|NCT00773734|Secondary|LTE Study: Change From Baseline in the Medical Outcome Study Short Form, SF-36, Version 2; Physical Component Summary Score at 2 Years|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Month 24|ITT; Includes participants who entered the long-term extension period||units on a scale||Standard Deviation|Mean
777997|NCT00773734|Secondary|LTE Study: Change From Baseline in the Medical Outcome Study Short Form,SF-36, Version 2; Physical Component Summary Score at 18 Months|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Month 18|ITT; Includes participants who entered the long-term extension study||units on a scale||Standard Deviation|Mean
777998|NCT00773734|Secondary|LTE Study: Change From Baseline in the Medical Outcome Study Short Form, SF-36, Version 2; Mental Component Summary Score at 4 Years|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Month 48|ITT; Includes participants who entered the long-term extension period||units on a scale||Standard Deviation|Mean
778010|NCT00773734|Secondary|LTE Study: Percent Change From Baseline in the Percent of the Affected Body Surface Area (BSA) at 4 Years|The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant’s hand (entire palmar surface or “handprint”), which equates to approximately 1% of total BSA.|Week 0 to Month 48|ITT; participants who entered the long-term extension period||percent change||Standard Deviation|Mean
778626|NCT00782210|Secondary|Weekly Mean Daily (24h) Rescue Use|The patient was to record in the e-Diary the number of puffs of salbutamol (albuterol) Metered-Dose Inhaler used each day and night.|From Screening to week 48|FAS||Number of puffs||Standard Error|Mean
777999|NCT00773734|Secondary|LTE Study: Change From Baseline in the Medical Outcome Study Short Form, SF-36, Version 2; Mental Component Summary Score at 3 Years|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Month 36|ITT; Includes participants who entered the long-term extension study||units on a scale||Standard Deviation|Mean
778000|NCT00773734|Secondary|LTE Study: Change From Baseline in the Medical Outcome Study Short Form, SF-36, Version 2; Mental Component Summary Score at 2 Years|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Month 24|ITT; Includes participants who entered the long-term extension period||units on a scale||Standard Deviation|Mean
778001|NCT00773734|Secondary|LTE Study: Change From Baseline in the Medical Outcome Study Short Form, SF-36, Version 2; Mental Component Summary Score at 18 Months|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Month 18|ITT; Includes participants who entered the long term extension period||units on a scale||Standard Deviation|Mean
778002|NCT00773734|Secondary|LTE Study: Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at 4 Years|The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects’ quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis.|Week 0 to Month 48|Intent to Treat; Includes participants who entered the long term extension study||units on a scale||Standard Deviation|Mean
778003|NCT00773734|Secondary|LTE Study: Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at 3 Years|The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects’ quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis.|Week 0 to Month 36|Intent to Treat; Includes participants who entered the long term extension period||units on a scale||Standard Deviation|Mean
778004|NCT00773734|Secondary|LTE Study: Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at 2 Years|The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects’ quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis.|Week 0 to Month 24|Intent to Treat; Includes participants who entered the long term extension study||units on a scale||Standard Deviation|Mean
778005|NCT00773734|Secondary|LTE Study: Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at 18 Months|The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects’ quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis.|Week 0 to Month 18|Intent to Treat; Includes participants who entered the long term extension period||units on a scale||Standard Deviation|Mean
778006|NCT00773734|Secondary|LTE Study: Median Percent Change From Baseline in the Affected Body Surface Area (BSA) at 4 Years|The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant’s hand (entire palmar surface or “handprint”), which equates to approximately 1% of total BSA.|Week 0 to Month 48|Intent to Treat; participants who entered into the LTE period||percent change||Full Range|Median
778007|NCT00773734|Secondary|LTE Study: Median Percent Change From Baseline in the Affected Body Surface Area (BSA) at 3 Years|The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant’s hand (entire palmar surface or “handprint”), which equates to approximately 1% of total BSA.|Week 0 to Month 36|Intent to Treat; participants who entered into the long-term extension period||percent change||Full Range|Median
778011|NCT00773734|Secondary|LTE Study: Percent Change From Baseline in the Percent of the Affected Body Surface Area (BSA) at 3 Years|The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant’s hand (entire palmar surface or “handprint”), which equates to approximately 1% of total BSA.|Week 0 to Month 36|ITT; participants who entered the long-term extension period||percent change||Standard Deviation|Mean
778012|NCT00773734|Secondary|LTE Study: Percent Change From Baseline in the Percent of the Affected Body Surface Area (BSA) at 2 Years|The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant’s hand (entire palmar surface or “handprint”), which equates to approximately 1% of total BSA.|Week 0 to Month 24|ITT; participants who entered the long-term extension period||percent change||Standard Deviation|Mean
778013|NCT00773734|Secondary|LTE Study: Percent Change From Baseline in the Percent of the Affected Body Surface Area (BSA) at 18 Months|The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant’s hand (entire palmar surface or “handprint”), which equates to approximately 1% of total BSA.|Week 0 to Month 18|Intent to Treat; Placebo participants re-randomized at week 16; End of Period = Last observation carried forward in the period||percent change||Standard Deviation|Mean
778014|NCT00773734|Secondary|Core Study: Shift Change (1 or More Points on a 0 to 5 Point Scale) in Static Physician Global Assessment (sPGA) at Month 18, and Years 2, 3 and 4|Physician Global Assessment (sPGA) was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA is a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling. Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3).|Week 0 to Week 196|The Shift change in sPGA was not defined and analyzed. A response defined as achieving sPGA score 0 or 1 with at least 2 points reduction from baseline was a more meaningful clinical endpoint.|||||
778015|NCT00773734|Secondary|LTE Study: Percent Change From Baseline in PASI Score at 4 Years|The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score|Week 0 to Month 48|ITT; Participants who entered the long-term extension period||percent change||Standard Deviation|Mean
778016|NCT00773734|Secondary|LTE Study: Percent Change From Baseline in PASI Score at 3 Years|The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score|Week 0 to Month 36|ITT; Participants who entered the long-term extension period||percent change||Standard Deviation|Mean
778017|NCT00773734|Secondary|LTE Study: Percent Change From Baseline in PASI Score at 2 Years|The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score|Week 0 to Month 24|ITT; Participants who entered the long-term extension period||percent change||Standard Deviation|Mean
778018|NCT00773734|Secondary|LTE Study: Percent Change From Baseline in PASI Score at 18 Months|The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score|Week 0 to Month 18|ITT; Participants who entered the long-term extension period||percent change||Standard Deviation|Mean
778033|NCT00773734|Secondary|Core Study: Time to Achieve a PASI-90 Response During the Placebo Controlled Phase|For PASI-90 responders in the placebo-controlled period weeks 0-16, time to achieve PASI-90 was the time interval, inclusive, between the date of randomization (day 1) and the date of the first assessment where PASI-90 was achieved.|Weeks 0 to 16|Time to achieve PASI-90 was not defined or analyzed as there were too few such participants.|||||
778627|NCT00782210|Secondary|Weekly Mean Nighttime Rescue Use|The patient was to record in the e-Diary the number of puffs of salbutamol (albuterol) Metered-Dose Inhaler used each day and night.|From Screening to week 48|FAS||Number of puffs||Standard Error|Mean
778019|NCT00773734|Secondary|LTE Study: Percentage of Participants Who Achieved a 100% Improvement (Response) in the PASI Score at 18 Months, 2 Years, 3 Years and 4 Years|PASI-100 response is the percentage of participants who achieved at a 100% reduction (improvement) from baseline in PASI score of the long-term extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Month 48|The PASI 100 was not defined and analyzed since there were too few such participants.|||||
778020|NCT00773734|Secondary|LTE Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at 4 Years|PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 196 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Month 48|ITT; Participants who entered the long-term extension period||percentage of participants||95% Confidence Interval|Number
778021|NCT00773734|Secondary|LTE Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at 3 Years|PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 148 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Month 36|ITT; Participants who entered the long-term extension period||percentage of participants||95% Confidence Interval|Number
778022|NCT00773734|Secondary|LTE Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at 2 Years|PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 100 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Month 24|ITT; Participants who entered the long-term extension period||percentage of participants||95% Confidence Interval|Number
778023|NCT00773734|Secondary|LTE Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at 18 Months|PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 76 of the long-term extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Month 18|ITT; Participants who entered the long-term extension period||percentage of participants||95% Confidence Interval|Number
778024|NCT00773734|Secondary|LTE Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at 4 Years|PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Month 48|ITT; Participants who entered the long-term extension period||percentage of participants||95% Confidence Interval|Number
778025|NCT00773734|Secondary|LTE Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at 3 Years|PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Month 36|ITT; Participants who entered the long-term extension period||percentage of participants||95% Confidence Interval|Number
778026|NCT00773734|Secondary|LTE Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at 2 Years|PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Month 24|ITT; Participants who entered the long-term extension period||percentage of participants||95% Confidence Interval|Number
778027|NCT00773734|Secondary|LTE Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at 18 Months|PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Month 18|ITT; Participants who entered the long-term extension period||percentage of participants||95% Confidence Interval|Number
778028|NCT00773734|Secondary|LTE Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in the PASI Score at 4 Years|PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Month 48|ITT; Participants who entered the long-term extension period||percentage of participants||95% Confidence Interval|Number
778029|NCT00773734|Secondary|LTE Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in the PASI Score at 3 Years|PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Month 36|ITT; Participants who entered the long-term extension period||percentage of participants||95% Confidence Interval|Number
778030|NCT00773734|Secondary|LTE Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in the PASI Score at 2 Years|PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Month 24|ITT; participants who entered the long-term extension study||percentage of participants||95% Confidence Interval|Number
778031|NCT00773734|Secondary|LTE Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in the PASI Score at 18 Months|PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Month 18|ITT; participants who entered the long-term extension study||percentage of participants||95% Confidence Interval|Number
778032|NCT00773734|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAE) in the Apremilast Exposure Period|An AE was any noxious, unintended, or untoward medical occurrence, that may appear or worsen in a participant during the course of study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) was considered an AE. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above. An AE is a treatment emergent AE if the AE start date is on or after the date of the first dose of study drug and no later than 28 days after the last dose.|Week 0 to 6 years of study treatment; maximum duration of exposure was 314.6 weeks|Safety population: includes all participants who were treated with Apremilast||participants|||Number
778034|NCT00773734|Secondary|Core Study: Time to Achieve a PASI-75 Response During the Placebo Controlled Phase|For PASI-75 responders in the placebo-controlled period Weeks 0-16, time to achieve PASI-75 was defined as the time interval, inclusive between the date of randomization (day 1) and the date of the first assessment where PASI-75 is achieved.|Weeks 0 to 16|Includes PASI-75 responders during the placebo controlled phase.||weeks||Full Range|Median
778035|NCT00773734|Secondary|Core Study: Time to Achieve a PASI-50 Response During the Placebo Controlled Phase|For PASI-50 responders in the placebo-controlled period weeks 0-16, time to achieve PASI-50 was defined as the time interval, inclusive between the date of randomization (day 1) and the date of the first assessment where PASI-50 was achieved.|Week 0 to 16|Includes PASI-50 responders during the placebo controlled phase||weeks||Full Range|Median
778036|NCT00773734|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAE) in the Apremilast Exposure Period|An AE was any noxious, unintended, or untoward medical occurrence, that may appear or worsen in a participant during the course of study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) was considered an AE. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above. An AE is a treatment emergent AE if the AE start date is on or after the date of the first dose of study drug and no later than 28 days after the last dose.|Week 0-88; up to data cut off of 21 July 2011|Includes all participants who were treated with Apremilast||participants|||Number
778037|NCT00773734|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAE) in the Placebo Controlled Phase|An AE was any noxious, unintended, or untoward medical occurrence, that may appear or worsen in a participant during the course of study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) was considered an AE. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above. An AE is a treatment emergent AE if the AE start date is on or after the date of the first dose of study drug and no later than 28 days after the last dose.|Week 0 to Week 16; up to data cut off of 21 July 2011|Safety population consisted of all participants who were randomized and received at least one dose of Investigational Product (IP)||participants|||Number
778038|NCT00773734|Secondary|Time to Loss of 50% of the PASI Response During the Observational Follow-up Phase Relative to the End of Treatment (Participants Who Had at Least a PASI-50 Response at the End of Treatment Phase)|Time to loss of response was modified to be 50% loss in the PASI response observed at the end of treatment for participants who achieved at least a PASI-50 at the end of treatment. This definition was changed since participants may have already lost their maximal PASI response prior to enrollment into the Observation Follow-up Phase. Included all participants that enrolled into the observational follow-up phase after the treatment phase.|Up to 4 weeks after the last dose|Participants who entered the observational follow-up phase and were PASI-50 responders at the beginning of the time interval.||weeks||95% Confidence Interval|Median
778039|NCT00773734|Secondary|Extension Study: Time to Loss of Response During the Treatment Phase of the Extension Study.|Time to 50% loss of the maximal improvement (achieved in either the core study or the extension study) during the treatment phase of the extension study, in participants who achieved ≥ PASI-50 in either the core study or during the treatment phase of the extension study|Week 0 to 52|This endpoint was not summarized since the time of the maximal improvement is variable and the maximal improvement could occur in either the core phase or the extension phase|||||
778040|NCT00773734|Secondary|Extension Study: Dose-response Relationship Using the Percent Reduction of PASI Scores at Week 52|Dose response relationship using percent reduction in PASI scores across dose groups at Week 52 compared to Week 0|Week 0 to Week 52|The dose-response relationship analysis was anticipated, however, since the extension study was optional and there was not placebo control, no formal testing of dose response was conducted|||||
778041|NCT00773734|Secondary|Extension Study: Change From Baseline in the Medical Outcome Study Short Form,SF-36, Version 2; Physical Component Summary Score at Week 52|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value..|Week 0 to Week 52|Includes participants who entered the extension study and had SF-36 assessment at Week 52; Intent to Treat||units on a scale||Standard Deviation|Mean
778042|NCT00773734|Secondary|Extension Study: Change From Baseline in the Medical Outcome Study Short Form,SF-36, Version 2; Mental Component Summary Score at Week 52|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Week 52|Includes participants who entered the extension study and had SF-36 assessment at Week 52; Intent to Treat;||units on a scale||Standard Deviation|Mean
778043|NCT00773734|Secondary|Extension Study: Change From Baseline in Medical Outcome Study Short Form,SF-36, Version 2; Physical Component Summary Score at Week 40|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Week 40|Includes participants who entered the extension study and had SF-36 assessment at Week 40; Intent to Treat||units on a scale||Standard Deviation|Mean
778044|NCT00773734|Secondary|Extension Study: Change From Baseline in the Medical Outcome Study Short Form,SF-36, Version 2; Mental Component Summary Score at Week 40|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Week 40|Includes participants who entered the extension study and had SF-36 assessment at Week 40; Intent to Treat||units on a scale||Standard Deviation|Mean
778045|NCT00773734|Secondary|Extension Study: Change From Baseline in the Medical Outcome Study Short Form,SF-36, Version 2; Physical Component Summary Score (PCS) at Week 32|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Week 32|Includes participants who entered the extension study and had SF-36 assessment at Week 32; Intent to Treat||units on a scale||Standard Deviation|Mean
778046|NCT00773734|Secondary|Extension Study: Change From Baseline in the Medical Outcome Study Short Form,SF-36, Version 2; Mental Component Summary Score at Week 32|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Week 32|Includes participants who entered the extension study and had SF-36 assessment at Week 32; Intent to Treat||units on a scale||Standard Deviation|Mean
778047|NCT00773734|Secondary|Extension Study: Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 52|The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects’ quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis.|Week 0 to Week 52|Includes participants who entered the extension study and had DLQI assessment at Week 40; Intent to Treat||units on a scale||Standard Deviation|Mean
778048|NCT00773734|Secondary|Extension Study: Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 40|The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects’ quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis.|Week 0 to Week 40|Includes participants who entered the extension study and had DLQI assessment at Week 40; Intent to Treat||units on a scale||Standard Deviation|Mean
778049|NCT00773734|Secondary|Extension Study: Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 32|The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects’ quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis.|Week 0 to Week 32|Includes participants who entered the extension study and had DLQI assessment at Week 32; Intent to Treat||units on a scale||Standard Deviation|Mean
778050|NCT00773734|Secondary|Extension Study: Percent Change From Baseline in the Affected BSA at Week 52|The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant’s hand (entire palmar surface or “handprint”), which equates to approximately 1% of total BSA.|Week 0 to Week 52|Includes participants who entered the extension study and had BSA assessment at Week 52; Intent to Treat;||percent change||Standard Deviation|Mean
778051|NCT00773734|Secondary|Extension Study: Percent Change From Baseline in the Affected BSA at Week 40|The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant’s hand (entire palmar surface or “handprint”), which equates to approximately 1% of total BSA.|Week 0 to Week 40|Includes participants who entered the extension study and had BSA assessment at Week 40; Intent to Treat||percent change||Standard Deviation|Mean
778052|NCT00773734|Secondary|Extension Study: Percent Change From Baseline in the Affected BSA at Week 32|The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant’s hand (entire palmar surface or “handprint”), which equates to approximately 1% of total BSA.|Week 0 to Week 32|Includes participants who entered the extension study and had a BSA assessment at Week 32; Intent to Treat||percent change||Standard Deviation|Mean
778053|NCT00773734|Secondary|Extension Study: Shift Change (1 or More Points on a 0 to 5 Point Scale) in Static Physician Global Assessment (sPGA) at Week 52|Physician Global Assessment (sPGA) was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA is a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the subject and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling. Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3).|Week 0 to Week 52|The Shift change in sPGA was not defined and analyzed. A response defined as achieving sPGA score 0 or 1 with at least 2 points reduction from baseline was a more meaningful clinical endpoint. See pre-specified outcome measures.|||||
778054|NCT00773734|Secondary|Extension Study: Shift Change (1 or More Points on a 0 to 5 Point Scale) in Static Physician Global Assessment (sPGA) at Week 40|Physician Global Assessment (sPGA) was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA is a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the subject and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling. Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3).|Week 0 to Week 40|The Shift change in sPGA was not defined and analyzed. A response defined as achieving sPGA score 0 or 1 with at least 2 points reduction from baseline was a more meaningful clinical endpoint. See pre-specified outcome measures.|||||
778055|NCT00773734|Secondary|Extension Study: Shift Change (1 or More Points on a 0 to 5 Point Scale) in Static Physician Global Assessment (sPGA) at Week 32|Physician Global Assessment (sPGA) was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA is a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the subject and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling. Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3).|Week 0 to Week 32|The Shift change in sPGA was not defined and analyzed. A response defined as achieving sPGA score 0 or 1 with at least 2 points reduction from baseline was a more meaningful clinical endpoint. See pre-specified outcome measures.|||||
778056|NCT00773734|Secondary|Extension Study: Percent Change in PASI Score at Week 52|The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score|Week 0 to Week 52|Includes participants who entered the extension study and had PASI assessment at Week 52; Intent to Treat;||percent change||Standard Deviation|Mean
778057|NCT00773734|Secondary|Extension Study: Percent Change in PASI Score at Week 40|The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score|Week 0 to Week 40|Includes participants who entered the extension study and had PASI assessment at Week 40; Intent to Treat;||percent change||Standard Deviation|Mean
778067|NCT00773734|Secondary|Extension Study: Percentage of Participants Who Achieved a 100% Improvement (Response) in the PASI Score at Week 40|A participant was classified as having achieved a PASI-100 response if the PASI score was reduced by at least 100% from baseline. The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 40|The PASI 100 was not defined and analyzed since there were too few such participants.|||||
778058|NCT00773734|Secondary|Extension Study: Percent Change in PASI Score at Week 32|The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score|Week 0 to Week 32|Includes participants who entered the extension study and had PASI assessment at Week 32; Intent to Treat||percent change||Standard Deviation|Mean
778059|NCT00773734|Other Pre-specified|Extension Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at Week 52|The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less severe disease.|Week 0 to Week 52|Includes participants who entered the extension study; LOCF was used.||percentage of participants||95% Confidence Interval|Number
778060|NCT00773734|Other Pre-specified|Extension Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at Week 40|The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less disease.|Week 0 to Week 40|Includes participants who entered the extension study; Intent to Treat||percentage of participants||95% Confidence Interval|Number
778061|NCT00773734|Other Pre-specified|Extension Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at Week 32|The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less severe disease.|Week 0 to Week 32|Includes participants who entered the extension study; Intent to Treat||percentage of participants||95% Confidence Interval|Number
778062|NCT00773734|Secondary|Extension Study: Time to Achieve PASI-100 During the Extension Study|For PASI-100 responders in the extension study, time to achieve PASI-100 was defined as the time interval, inclusive between the date of randomization (Day 1) and the date of the first assessment where PASI-100 was achieved.|Week 0 to Extension Study|Time to achieve PASI-100 score was not defined and analyzed as there were too few such participants who did not achieve responses in the core study but achieved in the extension study|||||
778063|NCT00773734|Secondary|Extension Study: Time to Achieve PASI-90 During the Extension Study|For PASI-90 responders in the extension study, time to achieve PASI-90 was defined as the time interval, inclusive between the date of randomization (Day 1) and the date of the first assessment where PASI-90 was achieved.|Week 0 to Extension study|Time to achieve PASI-90 score was not defined and analyzed as there were too few such participants who did not achieve responses in the core study but achieved in the extension study|||||
778064|NCT00773734|Secondary|Extension Study: Time to Achieve PASI-50 During the Extension Study|For PASI-50 responders in the extension study, time to achieve PASI-50 was defined as the time interval, inclusive between the date of randomization (Day 1) and the date of the first assessment where PASI-50 was achieved.|Week 0 to Week 52|Time to achieve PASI-50 score was not defined and analyzed as there were too few such participants who did not achieve responses in the core study but achieved in the extension study|||||
778065|NCT00773734|Secondary|Extension Study: Time to Achieve PASI-75 During the Extension Study|For PASI-75 responders in the extension study, time to achieve PASI-75 was defined as the time interval, inclusive between the date of randomization (Day 1) and the date of the first assessment where PASI-75 was achieved.|Week 0 to Week 52|Time to achieve PASI-75 score was not defined and analyzed as there were too few such participants who did not achieve responses in the core study but achieved in the extension study|||||
778066|NCT00773734|Secondary|Extension Study: Percentage of Participants Who Achieved a 100% Improvement (Response) in the PASI Score at Week 52|A participant was classified as having achieved a PASI-100 response if the PASI score was reduced by at least 100% from baseline. The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 52|The PASI 100 was not defined and analyzed since there were too few such participants.|||||
778068|NCT00773734|Secondary|Extension Study: Percentage of Participants Who Achieved a 100% Improvement (Response) in the PASI Score at Week 32|A participant was classified as having achieved a PASI-100 response if the PASI score was reduced by at least 100% from baseline. The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 32|The PASI 100 was not defined and analyzed since there were too few such participants.|||||
778069|NCT00773734|Secondary|Extension Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at Week 52|PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 52 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 52|Includes participants who entered the extension study; Intent to Treat; Non-responder imputation||percentage of participants||95% Confidence Interval|Number
778070|NCT00773734|Secondary|Extension Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at Week 40|PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 40 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 40|Includes participants who entered the extension study; Intent to Treat; Non-responder imputation||percentage of participants||95% Confidence Interval|Number
778071|NCT00773734|Secondary|Extension Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at Week 32|PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 32 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 32|Includes participants who entered the extension study; Intent to Treat; Non-responder imputation||percentage of participants||95% Confidence Interval|Number
778072|NCT00773734|Secondary|Extension Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at Week 52|PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score at Week 52 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 52|Includes participants who entered the extension study; Intent to Treat; Non-responder imputation||percentage of participants||95% Confidence Interval|Number
778073|NCT00773734|Secondary|Extension Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at Week 40|PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score at Week 16 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 40|Includes participants who entered the extension study; Intent to Treat; Non-responder imputation||percentage of participants||95% Confidence Interval|Number
778074|NCT00773734|Secondary|Extension Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at Week 32|PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score at Week 32 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 32|Includes participants who entered the extension study; Intent to Treat; Non-responder imputation||percentage of participants||95% Confidence Interval|Number
778075|NCT00773734|Secondary|Extension Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in the PASI Score at Week 40|PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 40 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 40|Includes participants who entered the extension study; Intent to Treat; Non-responder imputation||percentage of participants||95% Confidence Interval|Number
778076|NCT00773734|Secondary|Extension Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in the PASI Score at Week 32|PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 32 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 32|Includes participants who entered the extension study; Intent to Treat; Non-responder imputation||percentage of participants||95% Confidence Interval|Number
778077|NCT00773734|Secondary|Extension Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in the PASI Score at Week 52|PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 52. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 52|Includes participants who entered the extension study; LOCF was used.||percentage of participants||95% Confidence Interval|Number
778078|NCT00773734|Secondary|Core Study: Time to Maximum Plasma Concentration of Drug (Tmax)|Time to achieve maximum plasma concentration (tmax) observed at Week 24 (Time to achieve steady-state Tmax)|Week 24|Pharmacokinetic population; samples were not obtained from participants who were randomized to placebo||hours||Full Range|Median
778079|NCT00773734|Secondary|Core Study: Time to Maximum Plasma Concentration of Drug (Tmax)|Time to achieve maximum plasma concentration (Cmax) observed at Week 14 (Time to achieve steady-state Tmax)|Week 14; Predose, 0.5, 1, 2, 3, 4, and 8 hours after the morning dose of apremilast|Pharmacokinetic population; samples were not obtained from participants who were randomized to placebo||hours||Full Range|Median
778080|NCT00773734|Secondary|Core Study: Peak; (Maximum) Plasma Concentration (Cmax) of Apremilast|The maximum observed plasma concentration of apremilast observed at Week 24 (steady-state Cmax)|Week 24|Pharmacokinetic population; samples were not obtained from participants who were randomized to placebo.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
778081|NCT00773734|Secondary|Core Study: Peak; (Maximum) Plasma Concentration (Cmax) of Apremilast|The maximum observed plasma concentration of apremilast observed at Week 14 (steady-state Cmax)|Week 14; Predose, 0.5, 1, 2, 3, 4, and 8 hours after the morning dose of apremilast|Pharmacokinetic population; samples were not obtained from participants who were randomized to placebo||ng/mL||Geometric Coefficient of Variation|Geometric Mean
778082|NCT00773734|Secondary|Core Study: Area Under the Plasma Concentration-time Curve (AUC0-8)|Area under the concentration versus time curve from time 0 (pre-dose) to 8 hours, calculate using the linear trapezoid rule.|Week 24|Pharmacokinetic population; samples were not obtained from participants who were randomized to placebo.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
778083|NCT00773734|Secondary|Core Study: Area Under the Plasma Concentration-time Curve (AUC0-8)|Area under the concentration versus time curve from time 0 (pre-dose) to 8 hours, calculated using the linear trapezoid rule.|Week 14; Predose, 0.5, 1, 2, 3, 4, and 8 hours after the morning dose of apremilast|Pharmacokinetic population; samples were not obtained from participants who were randomized to placebo||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
778084|NCT00773734|Secondary|Core Study: Change From Baseline in the Medical Outcome Study Short Form 36-Item Health Survey (SF-36), Version 2 Physical Component Summary Score at Week 24|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Week 24|Intent to Treat; Placebo participants re-randomized at week 16; End of Period = Last observation carried forward in the period||units on a scale||Standard Deviation|Mean
778126|NCT00774046|Primary|Response to Induction Chemotherapy (CR or PR)|Complete remission (CR): <5% bone marrow blasts with recovery of peripheral blood counts; complete cytogenetic remission, the disappearance of any pre-existing cytogenetic abnormality Partial remission (PR): >5% bone marrow blasts, but less than the pre-treatment blast percentage within the bone marrow Resistant disease (RD): no significant cytoreduction in bone marrow leukemic cells from pre-treatment levels Not evaluable (NE): patients who died during induction chemotherapy or who withdrew from follow-up before assessment could be made|Day 28-40|||percentage of participants||95% Confidence Interval|Number
778085|NCT00773734|Secondary|Core Study: Change From Baseline in the Medical Outcome Study Short Form 36-Item Health Survey (SF-36), Version 2; Mental Component Summary Score at Week 24|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Week 24|Intent to Treat; Placebo participants re-randomized at week 16; End of Period = Last observation carried forward in the period||units on a scale||Standard Deviation|Mean
778086|NCT00773734|Secondary|Core Study: Change From Baseline in the Medical Outcome Study Short Form 36-Item Health Survey (SF-36), Version 2; Physical Component Summary Score at Week 16|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to week 16|The intent-to-treat (ITT) population = all randomized participants. Last observation carried forward (LOCF) method was used for imputing missing values||units on a scale||Standard Error|Least Squares Mean
778087|NCT00773734|Secondary|Core Study: Change From Baseline in the Medical Outcome Study Short Form 36-Item Health Survey (SF-36), Version 2; Mental Component Summary Score at Week 16|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Week 16|The intent-to-treat (ITT) population = all randomized participants. Last observation carried forward (LOCF) method was used for imputing missing values||units on a scale||Standard Error|Least Squares Mean
778088|NCT00773734|Secondary|Core Study: Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 24|The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects’ quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis.|Week 0 to Week 24|Intent to Treat; Placebo participants re-randomized at week 16; End of Period = Last observation carried forward in the period||units on a scale||Standard Deviation|Mean
778089|NCT00773734|Secondary|Core Study: Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16|The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects’ quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis.|Week 0 to Week 16|The intent-to-treat (ITT) population = all randomized participants. Last observation carried forward (LOCF) method was used for imputing missing values||units on a scale||Standard Error|Least Squares Mean
778090|NCT00773734|Secondary|Core Study: Percent Change From Baseline in the Percent of Affected Body Surface Area (BSA) During the Active Treatment Phase at Week 24|The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant’s hand (entire palmar surface or “handprint”), which equates to approximately 1% of total BSA.|Week 0 to Week 24|Intent to Treat; Placebo participants re-randomized at week 16; End of Period = Last observation carried forward in the period||percent change||Standard Deviation|Mean
778091|NCT00773734|Secondary|Core Study: Percent Change From Baseline in the Percent of Affected Body Surface Area (BSA) During the Placebo Controlled Phase|The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant’s hand (entire palmar surface or “handprint”), which equates to approximately 1% of total BSA.|Week 0 to Week 16|The intent-to-treat (ITT) population = all randomized participants. Last observation carried forward (LOCF) method was used for imputing missing values||percent change||Standard Error|Least Squares Mean
778099|NCT00773734|Secondary|Core Study: Percentage of Participants Who Achieved a 100% Improvement (Response) in the PASI Score at Week 24|A participant was classified as having achieved a PASI-100 response if the PASI score was reduced by at least 100% from baseline. The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 24|The PASI 100 was not defined and analyzed since there were too few such participants.|||||
778092|NCT00773734|Secondary|Core Study: Shift Change (1 or More Points on a 0 to 5 Point Scale) in Static Physician Global Assessment (sPGA) at Week 24|Physician Global Assessment (sPGA) was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA is a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling. Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3).|Week 0 to Week 24|The Shift change in sPGA was not defined and analyzed. A response defined as achieving sPGA score 0 or 1 with at least 2 points reduction from baseline was a more meaningful clinical endpoint.|||||
778093|NCT00773734|Secondary|Core Study: Shift Change (1 or More Points on a 0 to 5 Point Scale) in Static Physician Global Assessment (sPGA) at Week 16|Physician Global Assessment (sPGA) was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA is a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling. Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3).|Week 0 to Week 16|The Shift change in sPGA was not defined and analyzed. A response defined as achieving sPGA score 0 or 1 with at least 2 points reduction from baseline was a more meaningful clinical endpoint. See other pre-specified outcome measures.|||||
778094|NCT00773734|Other Pre-specified|Core Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at Week 24|The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less severe disease|Week 0 and Week 24|Intent to Treat; Placebo participants re-randomized at Week 16; Last observation carried forward in the period||percentage of participants||95% Confidence Interval|Number
778095|NCT00773734|Other Pre-specified|Core Study: Percentage of Participants With a Static Physician Global Assessment (sPGA) Greater Than 2 at Baseline Who Achieved a Score of 0 or 1 at Week 16|The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less severe disease|Week 0 to Week 16|Intent to Treat; Last observation carried forward (LOCF) method was used for imputing missing values||percentage of participants|||Number
778096|NCT00773734|Secondary|Core Study: Percent Change From Baseline in PASI Score at Week 24|The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score|Week 0 to Week 24|Intent to Treat; Placebo participants re-randomized at week 16; End of Period = Last observation carried forward in the period||percent change||Standard Deviation|Mean
778097|NCT00773734|Secondary|Core Study: Percent Change From Baseline in PASI Score at Week 16|The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score.|Week 0 to Week 16|The intent-to-treat (ITT) population = all randomized participants. Last observation carried forward (LOCF) method was used for imputing missing values||Percent change||Standard Error|Least Squares Mean
778098|NCT00773734|Secondary|Core Study: Time to Achieve a PASI-100 Response During the Placebo Controlled Phase|For PASI-100 responders in the placebo-controlled period weeks 0-16, time to achieve PASI-100 was the time interval, inclusive, between the date of randomization (day 1) and the date of the first assessment where PASI-90 was achieved.|Weeks 0 to 16|Time to achieve PASI 100 was not defined or analyzed as there were too few participants.|||||
778122|NCT00774046|Secondary|Numbers of Stem Cells Collected||1-5 days from initiation of stem cell collection|Subset of patients in CR who underwent mobilization and attempted stem cell collection.||10^6 CD34+ cells/kg||Full Range|Median
778100|NCT00773734|Secondary|Core Study: Percentage of Participants Who Achieved a 100% Improvement (Response) in the PASI Score at Week 16|A participant was classified as having achieved a PASI-100 response if the PASI score was reduced by at least 100% from baseline. The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 16|The PASI 100 was not defined and analyzed since there were too few such participants.|||||
778101|NCT00773734|Secondary|Core Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at Week 24|PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 24. The improvement in PASI score was used as a measure of efficacy..The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 24|Intent to Treat; Placebo participants re-randomized at week 16; End of Period = Last observation carried forward in the period||percentage of participants||95% Confidence Interval|Number
778102|NCT00773734|Secondary|Core Study: Percentage of Participants Who Achieved a 90% Improvement (Response) From Baseline in the PASI Score at Week 16|PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 16|The intent-to-treat (ITT) population = all randomized participants. Last observation carried forward (LOCF) method was used for imputing missing values||percentage of participants|||Number
778103|NCT00773734|Secondary|Core Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at Week 24|PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score at Week 24. The improvement in PASI score was used as a measure of efficacy. The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 24|Intent to Treat; Placebo participants re-randomized at week 16; End of Period = Last observation carried forward in the period||percentage of participants||95% Confidence Interval|Number
778104|NCT00773734|Secondary|Core Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in PASI Score at Week 16|PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 16|The intent-to-treat (ITT) population = all randomized participants. Last observation carried forward (LOCF) method was used for imputing missing values||percentage of participants|||Number
778105|NCT00773734|Secondary|Core Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in PASI Score at Week 24|PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 24. The improvement in PASI score was used as a measure of efficacy.The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head,trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 24|Intent to Treat; Placebo participants re-randomized at Week 16; End of Period = Last observation carried forward in the period||percentage of participants||95% Confidence Interval|Number
778123|NCT00774046|Secondary|Feasibility of Stem Cell Collection|Feasibility is the ability to cryopreserve >=2.0 x 10^6 CD34+ cells/kg|1-5 days from initiation of stem cell collection|Subset of patients in CR who underwent mobilization and attempted stem cell collection.||percentage of participants||95% Confidence Interval|Number
778124|NCT00774046|Primary|Relapse-free Survival|Relapse is defined as bone marrow blasts >5% if the patient had achieved a complete remission, or the recurrence of any clonal cytogenetic abnormality.|Up to 2000 days|||Days||Inter-Quartile Range|Median
778125|NCT00774046|Primary|Overall Survival||Up to 2000 days|||Days||Inter-Quartile Range|Median
778127|NCT00774163|Secondary|Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Subjective Fever Reported||Day 0 through 6 weeks after Day 0|||days with symptom reported|days of observation||Number
778106|NCT00773734|Primary|Core Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in Psoriasis Area and Severity Index (PASI) at Week 16|PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 and Week 16|The intent-to-treat (ITT) population = all randomized participants. Last observation carried forward (LOCF) method was used for imputing missing values||percentage of participants|||Number
778107|NCT00773786|Secondary|Change From Baseline in Inspiratory Capacity at 1 Week|Change from baseline in Inspiratory Capacity (IC) after 1 week on Brovana or Placebo (measured 2 hours post dose). (Change = 1 week - baseline).|baseline and 2 hours after dosing|||Liters||Standard Error|Mean
778108|NCT00773786|Secondary|Change From Baseline in Forced Vital Capacity (FVC) at 1 Week|Change from baseline in Forced Vital Capacity (FVC) after 1 week on Brovana or Placebo. (Change = 1 week - baseline)|baseline and 1 week|||Liters||Standard Error|Mean
778109|NCT00773786|Primary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at 1 Week|Change from baseline in Forced Expiratory Volume in 1 second (FEV1) after 1 week on Brovana or Placebo (measured 2 hours post dose). (Change = 1 week - baseline)|baseline and 1 week|||Liters||Standard Error|Mean
778110|NCT00773955|Secondary|Duration of Response||From the date at which the patient's earliest best objective status is first noted to be either a CR or PR to the earliest date progression is documented, assessed up to 5 years|There were no confirmed responses qualifying for this endpoint.|||||
778111|NCT00773955|Secondary|Time to Disease Progression|"Time to disease progression is defined as the time from registration to the earliest date documentation of disease progression. Estimated using the method of Kaplan-Meier.
Per the RECIST criteria, progression is defined as at least a 20% increase in the sum of Longest Dimension (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions."|From registration to the earliest date documentation of disease progression, assessed up to 5 years|All 15 patients were analyzed for this endpoint.||months||95% Confidence Interval|Median
778112|NCT00773955|Secondary|Survival Time|Estimated using the method of Kaplan-Meier.|From registration to death due to any cause, assessed up to 5 years|All 15 patients were analyzed for this endpoint.||months||95% Confidence Interval|Median
778113|NCT00773955|Primary|Number of Participants With Confirmed Tumor Response Defined to be Either a Complete Response (CR) or Partial Response (PR)|"The number of successes will be estimated by counting the number of participants with confirmed responses. A confirmed tumor response is defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions:
A Complete Response (CR) requires the disappearance of all target lesions
A Partial Response (PR) requires a >=30% decrease in the sum of the longest diameter of target lesions from baseline measurements."|During the first 6 courses of treatment|One patient discontinued therapy after one cycle of treatment due to persistent grade 1 thrombocytopenia. Therefore, fourteen patients were evaluable for the primary end point at the interim analysis.||participants|||Number
778114|NCT00773968|Secondary|Percentage of Participants Who Required Red Blood Cell Transfusions||Weeks 1 to 28|Safety population.||percentage of participants|||Number
778115|NCT00773968|Secondary|Percentage of Participants Requiring Any Dose Adjustment During Dose Titration Period (DTP) and EEP|The methoxy polyethylene glycol-epoetin beta dose adjustment (dose increase or decrease) was required: if a single Hb concentration was either greater than or equal to (≥) 13 g/dL or less than or equal to (≤) 9 g/dL; if the difference of 2 consecutive Hb concentrations was ≥2 g/dL; when the values of scheduled Hb assessments on the days of drug administration and on the previous study visit were both out of range of 10.5 to 11.5 g/dL and the difference between the reference value (average Hb concentration calculated on the basis of all Hb assessments taken at Weeks -4, -2, and 0) and the most recent value was >1 g/dL; and when the values of scheduled Hb assessments on the days of drug administration and on the previous study visit were both out of range of 10 to 12 g/dL. Dose adjustment could be made at any time at the discretion of the clinician if clinically warranted.|DTP: Weeks 1 to 16; EEP: Weeks 17 to 28|Per protocol population.||percentage of participants|||Number
778116|NCT00773968|Secondary|Median Time Spent in the Hb Range of 10.0 to 12.0 g/dL During the EEP||EEP: Weeks 17 to 28|Per protocol population.||days||Full Range|Median
778117|NCT00773968|Secondary|Percentage of Participants Maintaining Hb Concentrations Within the Range of 10.0 to 12.0 g/dL Throughout EEP||EEP: Weeks 17 to 28|Per protocol population.||percentage of participants||95% Confidence Interval|Number
778118|NCT00773968|Secondary|Change in Hb Concentrations Between EEP and Stability Verification Period (SVP)|Hb concentrations during SVP were the reference Hb concentrations. For each assessment period (SVP and EEP) the average Hb concentration was calculated on the basis of all Hb assessments taken during the assessment period. Change in average Hb concentration from reference range (SVP) was calculated.|SVP: Week -4 to Week 0; EEP: Weeks 17 to 28|Per protocol population.||g/dL||Standard Deviation|Mean
778119|NCT00773968|Primary|Percentage of Participants Maintaining Their Mean Hb Concentration Within Plus/Minus (±) 1 Grams Per Deciliter (g/dL) of the Reference Range and Between 10.0 and 12.0 g/dL During Efficacy Evaluation Period (EEP)|The reference Hb was defined as the average Hb concentration calculated on the basis of all Hb assessments taken at Weeks -4, -2, and 0 (before the first dose administration).|EEP: Weeks 17 to 28|Per protocol population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta and for whom the data for at least one follow-up variable were available and were without any major protocol violation.||percentage of participants||95% Confidence Interval|Number
778120|NCT00774046|Secondary|Disease-free Survival in Patients Undergoing Autologous Stem Cell Transplant||Up to 883 days|Subset of patients undergoing autologous stem cell transplant||Days||Full Range|Median
778121|NCT00774046|Secondary|Overall Survival in Patients Undergoing Autologous Stem Cell Transplant||Up to 817 days|Subset of patients undergoing autologous stem cell transplant||Days||Full Range|Median
778144|NCT00774267|Primary|Percent Change From Baseline in Mammographic Breast Density at Month 24|The digitized mammogram pairs were analyzed by a single trained radiologist who determined the density of the breast using software. The only left craniocaudal view was used for assessing breast density.|primary study baseline, Month 24|All available participants were analyzed. Here, ‘N’ (number of participants analyzed) signifies those participants who had technically acceptable mammograms available at primary study baseline and Month 24.||percent change||Standard Deviation|Mean
778145|NCT00774306|Secondary|Incidence of Acute Seizures, Incidence of Late Seizures, Overall Neurologic Function (as Measured by Modified Rankin Scale Scores)||8 weeks, 16 weeks||||||
778146|NCT00774306|Primary|Change in Serum Cholesterol, Non-HDL Cholesterol, HDL Cholesterol, Lipoprotein(a), and C-reactive Protein From Baseline to Second Draw and Third Draw in Each of the 4 Study Arms||8 weeks, 16 weeks||||||
778147|NCT00774397|Secondary|Trough Concentration (Cpre,ss) of PegIFN at Steady State|C(pre,ss) is defined as pre-dose (trough) concentration of PegIFN in plasma at steady state immediately before administration of the next dose.|Week 8, week 10, week 12, week 24|All evaluable patients were included in the pharmacokinetic analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
778148|NCT00774397|Secondary|Trough Concentration (Cpre,ss) of Ribavirin at Steady State (Receiving 1200 mg/Day RBV)|C(pre,ss) is defined as pre-dose (trough) concentration of Ribavirin in plasma at steady state immediately before administration of the next dose.|Week 8, week 10, week 12, week 24|All evaluable patients were included in the pharmacokinetic analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
778149|NCT00774397|Secondary|Trough Concentration (Cpre,ss) of Ribavirin at Steady State (Receiving 1000 mg/Day RBV)|C(pre,ss) is defined as pre-dose (trough) concentration of Ribavirin in plasma at steady state immediately before administration of the next dose.|Week 8, week 10, week 12, week 24|All evaluable patients were included in the pharmacokinetic analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
778150|NCT00774397|Secondary|Trough Concentration (Cpre,ss) of Faldaprevir at Steady State|C(pre,ss) is defined as pre-dose (trough) concentration of Faldaprevir in plasma at steady state immediately before administration of the next dose.|Week 8, week 10, week 12, week 24|All evaluable patients were included in the pharmacokinetic analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
778151|NCT00774397|Secondary|Number of Patients [N(%)] With Transitions Relative to Reference Range for Laboratory Parameter Total Bilirubin|Number of patients with normal or low baseline moved to high .|Baseline and Week 24|Treated Set (for patients with normal or low baseline Total Bilirubin)||percentage of patients|||Number
778152|NCT00774397|Secondary|Change From Baseline to Week 24 in Total Bilirubin of the Patients|Baseline is defined as the last value before the administration of BI 201335 or placebo.|Baseline and Week 24|Treated Set (for patients with change from baseline in Total Bilirubin at Week 24)||mg/dL||Standard Deviation|Mean
778153|NCT00774397|Secondary|Number of Patients [N(%)] With Transitions Relative to Reference Range for Laboratory Parameter ALT/GPT,SGPT|Number of patients with normal or low baseline moved to high .|Baseline and Week 24|Treated Set (for patients with normal or low baseline ALT/GPT,SGPT)||percentage of patients|||Number
778154|NCT00774397|Secondary|Change From Baseline to Week 24 in ALT/GPT,SGPT of the Patients|Baseline is defined as the last value before the drug administration of BI 201335 or placebo.|Baseline and Week 24|Treated Set (for patients with change from baseline in ALT/GPT,SGPT at Week 24)||U/L||Standard Deviation|Mean
778155|NCT00774397|Secondary|Number of Patients [N(%)] With Transitions Relative to Reference Range for Laboratory Parameter Absolute Neutrophils|Number of patients with normal or high baseline moved to low .|Baseline and Week 24|Treated Set (for patients with normal or high baseline Absolute Neutrophils)||percentage of patients|||Number
778156|NCT00774397|Secondary|Change From Baseline to Week 24 in Absolute Neutrophils of the Patients|Baseline is defined as the last value before the administration of BI 201335 or placebo.|Baseline and Week 24|Treated Set (for patients with change from baseline in Absolute Neutrophils at Week 24)||GI/L||Standard Deviation|Mean
778157|NCT00774397|Secondary|Number of Patients [N(%)] With Transitions Relative to Reference Range for Laboratory Parameter Haemoglobin|Number of patients with normal or high baseline moved to low .|Baseline and Week 24|Treated Set (for patients with normal or high baseline Haemoglobin)||percentage of patients|||Number
778158|NCT00774397|Secondary|Change From Baseline to Week 24 in Haemoglobin of the Patients|Baseline is defined as the last value before the administration of BI 201335 or placebo.|Baseline and Week 24|Treated Set (for patients with change from baseline in Haemoglobin at Week 24)||g/dL||Standard Deviation|Mean
778159|NCT00774397|Secondary|Global Assessment of Tolerability|"The investigator was to assess the tolerability of trial medication based on adverse events (AEs) and the laboratory evaluation.
Tolerability was assessed by the investigator according to the categories 'good', 'satisfactory', 'not satisfactory', and 'bad'."|Week 24|Per protocol set||percentage of patients|||Number
778160|NCT00774397|Secondary|Change From Baseline to Week 24 in Weight of the Patients|Baseline is defined as the last value before the administration of BI 201335 or placebo.|Baseline and Week 24|Treated Set (for patients with change from baseline in Weight at Week 24)||kg||Standard Deviation|Mean
778161|NCT00774397|Secondary|Change From Baseline to Week 24 in Pulse Rate|Baseline is defined as the last value before the administration of BI 201335 or placebo.|Baseline and Week 24|Treated Set (for patients with change from baseline in Pulse rate at Week 24)||bpm||Standard Deviation|Mean
778162|NCT00774397|Secondary|Change From Baseline to Week 24 in Diastolic Blood Pressure and Systolic Blood Pressure|Baseline is defined as the last value before the initial drug administration of BI 201335 or placebo.|Baseline and Week 24|Treated Set (for patients with change from baseline in Systolic blood pressure and Diastolic blood pressure at Week 24)||mmHg||Standard Deviation|Mean
778628|NCT00782210|Secondary|Weekly Mean Daytime Rescue Use|The patient was to record in the e-Diary the number of puffs of salbutamol (albuterol) Metered-Dose Inhaler used each day and night.|From Screening to week 48|FAS||Number of puffs||Standard Error|Mean
778163|NCT00774397|Secondary|Relapse|"Relapse was rebound after the viral load at end of all treatment had been below the lower limit of detection, or, if the value at end of all treatment was missing, after both the last value before End of Treatment (EOT) and the first value after End of Treatment were below the lower limit of detection.
Patients could experience relapse at any point post-treatment."|post-End of treatment (i.e. post 48 weeks)|Per protocol set||percentage of patients|||Number
778164|NCT00774397|Secondary|Breakthrough on PegIFN/RBV (Rebound While Only PegIFN/RBV Treatment Alone Was Still Ongoing)|Number of patients with Unconfirmed rebound (≥ 1log10 increase in HCV mRNA) while on PegIFN/RBV treatment + 5 days washout.|Week 24 through Week 48|Per protocol set||percentage of patients|||Number
778165|NCT00774397|Secondary|Breakthrough on BI 201335/Placebo (Rebound While All 3 Treatments Were Still Ongoing)|Number of patients with Unconfirmed rebound ( ≥ 1log10 increase in HCV mRNA) while on BI201335/placebo + 5 days washout.|Up to Week 24|Per protocol set||percentage of patients|||Number
778166|NCT00774397|Secondary|Virological Rebound|"Virological rebound is defined as increase of ≥ 1 log 10 in plasma HCV RNA level from a quantifiable nadir, or to ≥ 250 IU/mL after previous nadir < 25 IU/mL (detectable), or to ≥ 100 IU/mL after a previous viral load below the lower limit of detection.
Note that this is numerical rebound, not requiring confirmation with a re-measurement."|Week 24 or Week 48|Per protocol set||percentage of patients|||Number
778167|NCT00774397|Secondary|Time to Loss of Virological Response|"Time to loss of virological response, defined as the last value below the lower limit of detection in a patient who subsequently had 2 consecutive plasma HCV RNA level measurements ≥100 IU/mL. Patients that did not achieve suppression of plasma HCV RNA levels below the lower limit of detection until Week 24 were defined as having a time to failure of zero.
Time is expressed in Median number of days."|Week 24|Per protocol set||Number of days||95% Confidence Interval|Median
778168|NCT00774397|Secondary|Time to Reach a Plasma HCV RNA Level Below the Lower Limit of Detection|Summary of time (i.e Median number of days) to reach a plasma HCV RNA level below limit of detection (BLD)|On or after day 155 post end of all treatment|Per protocol set||Days||Full Range|Median
778169|NCT00774397|Secondary|Sustained Virological Response 12 Weeks (SVR12) After Completion of All Therapy|Sustained Virological Response 12 Weeks (SVR12) after completion of all therapy is defined as plasma HCV RNA level below the lower limit of detection at 12 weeks after completion of all therapy, i.e. at Week 36 or 60|Week 36 or Week 60|Per protocol set||percentage of patients|||Number
778170|NCT00774397|Secondary|End of Treatment Response at End of All Therapy|End of Treatment Response (ETR) is defined as plasma HCV RNA level below the lower limit of detection at end of all therapy, i.e. at Week 24 or Week 48|Week 24 or Week 48|Per protocol set||percentage of patients|||Number
778171|NCT00774397|Secondary|End of Treatment Response at Week 24|End of Treatment Response of BI 201335 or placebo (ETR BI 201335/placebo ) is defined as plasma HCV RNA level below the lower limit of detection at Week 24.|Week 24|Per protocol set||percentage of patients|||Number
778172|NCT00774397|Secondary|Complete Early Virological Response (cEVR)|Complete Early Virological Response (cEVR) is defined as plasma HCV RNA level below the lower limit of detection at Week 12|Week 12|Per protocol set||percentage of patients|||Number
778173|NCT00774397|Secondary|Extended Rapid Virological Response (eRVR)|Extended Rapid Virological Response (eRVR) is defined as plasma HCV RNA levels below the lower limit of quantification at Week 4 and below the lower limit of detection at Week 12|Week 4 and Week 12|Per protocol set||percentage of patients|||Number
778174|NCT00774397|Secondary|Early Virological Response (EVR)|Early Virological Response (EVR) is defined as ≥ 2 log 10 reduction in plasma HCV RNA level from baseline at Week 12|Baseline and Week 12|Per protocol set||percentage of patients|||Number
778175|NCT00774397|Secondary|Virological Response at Week 4|Viral load (plasma HCV RNA level) below the lower limit of quantification at Week 4 (< 25 IU/ml, detectable or undetectable)|Week 4|Per protocol set||percentage of patients|||Number
778176|NCT00774397|Secondary|Virological Response at Week 2|Viral load (plasma HCV RNA level) below the lower limit of quantification at Week 2 (< 25 IU/ml, detectable or undetectable)|Week 2|Per protocol set||percentage of patients|||Number
778177|NCT00774397|Primary|Sustained Virological Response 24 Weeks (SVR24) After Completion of All Therapy|"Virological (VL) response was defined as the plasma HCV RNA level below the lower limit of detection.
The first VL measurement that occurred in the time window ≥ Day 155 (from End Of Treatment on) was selected for the determination of SVR24.
Therefore, patients with virological load BLD 24 weeks after completion of therapy, who had a rebound after this time point (outside the defined time window of 155 days after end of all treatments) were identified as SVR24 achieved."|Day 155 after the end of all treatment|Per protocol set||percentage of patients||95% Confidence Interval|Number
778178|NCT00774397|Primary|Virological Response 4 Weeks After the End of Treatment With BI 201335 or Placebo|"An achieved virological response is defined as the plasma Hepatitis C Virus RiboNucleic Acid (HCV RNA) level below the lower limit of detection (BLD).
This data was only collected for patients, who stopped trial participation at Week 24 and did not continue with PegIFN/RBV until Week 48.
The lower limit of quantification (BLQ) of this assay was 25 IU/mL and the lower limit of detection (BLD) was 10 IU/mL at the time of the protocol finalisation. During the course of the trial, the manufacturer defined BLD as '< 25 IU/mL, not detectable' and BLQ as '< 25 IU/mL, detectable'."|Week 28|"Per protocol set (PPS): PPS was subset of full analysis set,consisted of all patients without important protocol deviations .
FAS was composed of all randomised patients who took at least 1 dose of study medication.
For this outcome, only patients who were not on PegIFN/RBV treatment 4 weeks after stop of BI 201335 or Placebo were investigated."||percentage of patients|||Number
778179|NCT00774748|Secondary|Standard Deviation of Participant's Own Glomerular Filtration Rate (GFR)|GFR was calculated from a creatinine blood level to establish a safe renal function that would validate anti-Xa levels. Low molecular weight heparin is primarily cleared from the body by the kidneys. Any condition that decreases kidney function can potentially decrease LMWH clearance, increasing its concentration in the blood and increasing the potential for excessive bleeding.|6 time points in approximately 3 months|Included all participants who had at lease one visit and one blood draw.||mL/min||Full Range|Mean
778264|NCT00775203|Secondary|HAMD-17 Remitters at Each Visit|Number of patients who are remitters (defined as patients who achieved a HAMD-17 total score ≤7) at each post-baseline visit.|Weeks 1, 2, 3, 4, 6, 8|Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. Last Observation Carried Forward (LOCF).||Participants|||Number
778180|NCT00774748|Primary|Average Subcutaneous Anti-Xa Blood Levels|Blood levels taken from the first and last visits (when available) were combined to get an average. The anti-Xa test reports the low molecular weight heparin concentration in the blood.|approximately 3 months|Participants were separated into the two dosing schedules, since the target anti-Xa level is different for the two different types of doses. The once daily dosing sub-group was analyzed for this primary outcome measure.||IU/mL||Full Range|Mean
778181|NCT00774748|Secondary|Percent Difference of Each Participant's Anti-Xa Blood Levels Between Day 1 and Day 7|Comparing anti-Xa levels from the first day of using the port and the last day of using the port. A percent difference is calculated by the current value has the previous value subtracted from it; this new number is divided by the absolute value of the previous value; then this new number is multiplied by 100. This allows each set of data to be compared to itself. Anti-Xa tests measure the concentration of low molecular weight heparin in the blood.|7 days|All participants, excluding two outliers of 97% and 150%||Percent||Full Range|Median
778182|NCT00774748|Secondary|Percent Difference of Each Participant's Anti-Xa Levels Without Port and Day One of Using the Port|Comparing subcutaneous baseline (without port) anti-Xa levels with day one of using the port. A percent difference is calculated by the current value has the previous value subtracted from it; this new number is divided by the absolute value of the previous value; then this new number is multiplied by 100. This allows each set of data to be compared to itself. Anti-Xa tests measure the concentration of low molecular weight heparin in the blood.|approximately 3 months|Twenty participants, excluding one outlier of 97%.||Percent||Full Range|Median
778183|NCT00774748|Secondary|Percent Difference of Each Participant's Subcutaneous Anti-Xa Levels|Anti-Xa subcutaneous blood levels are displayed in percent difference to show normal fluctuations of anti-Xa levels without using the port. A percent difference is calculated by the current value has the previous value subtracted from it; this new number is divided by the absolute value of the previous value; then this new number is multiplied by 100. This allows each set of data to be compared to itself. Anti-Xa tests measure the concentration of low molecular weight heparin in the blood.|6 time points (for each participant) in approximately 3 months|All participants were represented with a baseline fluctuation in percent difference.||Percent||Full Range|Median
778184|NCT00774787|Other Pre-specified|Local Skin Reactions|Mean maximum post-baseline intensity of investigator assessed local skin reactions (erythema, edema, weeping/exudate, flaking/scaling/dryness, scabbing/crusting, erosion/ulceration) by treatment area. 0 = none, 1 = mild, 2 = moderate, 3 = severe. Data from one patient, lost to follow-up immediately after cryotherapy, not included in these analyses.|Post baseline to end of study (4-8 weeks post-treatment)|One patient not included who was lost to follow-up immediately after baseline visit, and had no post-treatment data.||Scores on a scale||Standard Deviation|Mean
778185|NCT00774787|Secondary|Cosmetic Appearance Score at 4-8 Weeks Post-treatment|Cosmetic appearance score, based recall comparison to appearance at baseline. Seven point scale: +3 = treatment area is much better appearing; +2 = treatment area is moderately better appearing; + 1 = treatment area is slightly better appearing; 0 = treatment area appears same; -1 = treatment area is slightly worse appearing; -2 = treatment area is moderately worse appearing; -3 = treatment area is much worse appearing. Data from one patient, lost to follow-up immediately after cryotherapy, not included in these analyses.|4-8 weeks post-treatment|Patients who had end of study visit with cosmetic appearance assessment. Cosmetic appearance score, by treatment area, not included for one patient who was lost to follow-up immediately after baseline visit, and had no post-treatment data.||Scores on a scale||Standard Deviation|Mean
778186|NCT00774787|Post-Hoc|Complete Clearance of Actinic Keratoses at 4-8 Weeks Post-treatment|Complete clearance (actinic keratosis count of 0) in each respective area at 4-8 weeks post-treatment. Actinic keratoses at 4-8 weeks post-treatment visit includes all actinic keratoses in each respective treatment area, baseline and new.|4-8 weeks post-treatment|All patients enrolled.||Participants|Participants||Number
778187|NCT00774787|Primary|Change From Baseline in Actinic Keratoses Count at 4-8 Weeks Post-treatment|Percent change = [(actinic keratoses count at 4-8 weeks post-treatment)-(actinic keratoses count at baseline)]/(actinic keratoses count at baseline)]*100%. Data from one patient, lost to follow-up immediately after cryotherapy, not included in these analyses. Actinic keratoses at 4-8 weeks post-treatment visit includes all actinic keratoses in each respective treatment area, baseline and new.|Baseline, 4-8 weeks post-treatment|Patients who had end of study visit with count of actinic keratoses. Change not calculated for one patient who was lost to follow-up immediately after baseline visit, and had no post-treatment data. Actinic keratoses at 4-8 weeks post-treatment visit includes all actinic keratoses in each respective treatment area, baseline or new.||Percent change||Standard Deviation|Mean
778188|NCT00774800|Secondary|Area Under the Blood Glucose Time-Concentration Curve Blood Glucose (AUC[BG])|AUC(BG) values are reported for participants whose blood glucose (BG) was elevated higher than 140 milligrams per deciliter (mg/dL) within 4 hours of consuming a liquid meal. Blood samples were collected at 30, 20, 10, and within 5 minutes before; at 3, 6, 9, 12, 15, 20, 25 minutes; and every 10 minutes from minute 30 to 240 postdose.|Predose up to 4 hours after injection of study drug|Participants who received at least one dose of Humalog alone, Humalog + rHuPH20, Humulin-R + rHuPH20, or Humulin-R alone with evaluable AUC(BG) data.||minutes*milligrams per deciliter||90% Confidence Interval|Geometric Mean
778189|NCT00774800|Secondary|Time to Maximum Serum Insulin Concentration (Tmax)|Tmax was determined as the timepoint where the maximum of all valid concentration measurements for each measurement series was observed. Samples were taken 30, 20, and 10 minutes (mins) prior to treatment; every 3 mins from mins 0 through 15; at 20, 30, and 45 mins; every 30 mins from mins 60 through 240; and every 60 minutes from mins 300 through 480 postdose.|Predose up to 480 minutes postdose|Participants who received at least one dose of Humalog alone, Humalog + rHuPH20, Humulin-R + rHuPH20, or Humulin-R alone with evaluable tmax data.||minutes||Standard Deviation|Mean
778190|NCT00774800|Secondary|Maximum Serum Insulin Concentration (Cmax)|Cmax was determined as the maximum of all valid serum insulin concentration measurements for each measurement series. Samples were taken 30, 20, and 10 minutes (mins) prior to treatment; every 3 mins from mins 0 through 15; at 20, 30, and 45 mins; every 30 mins from mins 60 through 240; and every 60 minutes from mins 300 through 480 postdose.|Predose up to 480 minutes postdose|Participants who received at least one dose of Humalog alone, Humalog + rHuPH20, Humulin-R + rHuPH20, or Humulin-R alone with evaluable Cmax data||Picomoles per liter (pmol/L)||Standard Deviation|Mean
778191|NCT00774800|Primary|Area Under the Insulin Concentration-time Curve for the First Hour (AUC0-60)|AUC was derived as the area under the serum insulin concentration profile from 0 to time “t.” Samples were taken 30, 20, and 10 minutes (mins) prior to treatment; every 3 mins from mins 0 through 15; and at 20, 30, 45, and 60 mins postdose.|Predose up to 60 minutes postdose|Participants who received at least one dose of Humalog alone, Humalog + rHuPH20, Humulin-R + rHuPH20, or Humulin-R alone with evaluable AUC0-60 data.||nanomole*minute per liter (nmol*min/L)||Standard Deviation|Mean
778192|NCT00774852|Secondary|Proportion of Vaccinated Participants With a Competent Immune Response|"Among participants who are vaccinated, the number of who have a competent immune response at Week 52 as defined as having met both of the following criteria:
Pneumococcal vaccination response – absolute value >= 0.35 ug/mL and, when measured 4-6 weeks after vaccination, a >=2-fold increase from baseline in serotype-specific antibody titer for at least 50% of the serotypes tested.
Tetanus toxoid vaccination response – absolute value >=0.015 IU/mL and, when measured 4-6 weeks after vaccination, a 2-fold increase from baseline in antigen-specific antibody titer
Competent immune response is indicative of low disease activity."|Week 52|Intent-to-treat who completed Week 52 and were vaccinated.||percentage of participants|||Number
778193|NCT00774852|Secondary|Lupus Disease Activity – Total BILAG-2004|BILAG-2004 has 5 categories of scoring.Category A:defined by severe disease activity requiring any of the following treatments: 1) systemic high dose oral glucocorticoids, 2) IV pulse glucocorticoids, 3) systemic immunomodulators, or 4)therapeutic high dose anticoagulation in the presence of high dose steroids or immunomodulators. Category B:defined by moderate disease activity requiring any of the following treatments:1) systemic low dose oral glucocorticoids, 2) intramuscular or intra-articular or soft tissue glucocorticoids injection,3) topical glucocorticoids, 4) topical immunomodulators,5) antimalarials or thalidomide or prasterone or acitretin, or 6) symptomatic therapy.Category C:defined by mild disease.Category D is defined by inactive disease, previously affected.Category E is defined as the system never being involved.The categories are converted to a numeric score (A=9, B=3, C=1, D=0, E=0) and treated as a continuous variable. Higher score= more severe disease activity.|Week 52|Intent-to-treat who completed Week 52 and BILAG 2004 data available.||units on a scale||Standard Deviation|Mean
778194|NCT00774852|Secondary|Lupus Disease Activity – SF-36 Scores Percent Change From Baseline|"Lupus disease activity was assessed by 7 different measures: anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment, SF36 total scores, and BILAG-2004 scores.
The SF-36 is a quality of life assessment that was performed at Weeks 9, 24, 36, 52, and 104. Eight scale scores are derived from responses to the 36 items of the SF-36 questionnaire which were combined to produce the Physical Component Score and the Mental Component Score. The Physical Component Score is based on the Physical Functioning Scale (10 items), the Role-Physical Scale (4 items), the Bodily Pain Scale (2 items), and the General Health Scale (5 items). The Mental Component Score is based upon the Vitality Scale (4 items), the Social Functioning Scale (2 items), the Role-Emotional Scale (3 items) and the Mental Health Scale (5 items). Each component score is transformed into a 0-100 scale, with higher numbers indicating greater quality of life."|Week 104|Intent-to-treat who completed Week 104 and had SF-36 data available.||percent change||Standard Deviation|Mean
778195|NCT00774852|Secondary|Lupus Disease Activity – SF-36 Scores|"Lupus disease activity was assessed by 7 different measures: anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment, SF36 total scores, and BILAG-2004 scores.
The SF-36 is a quality of life assessment that was performed at Weeks 9, 24, 36, 52, and 104. Eight scale scores are derived from responses to the 36 items of the SF-36 questionnaire which were combined to produce the Physical Component Score and the Mental Component Score. The Physical Component Score is based on the Physical Functioning Scale (10 items), the Role-Physical Scale (4 items), the Bodily Pain Scale (2 items), and the General Health Scale (5 items). The Mental Component Score is based upon the Vitality Scale (4 items), the Social Functioning Scale (2 items), the Role-Emotional Scale (3 items) and the Mental Health Scale (5 items). Each component score is transformed into a 0-100 scale, with higher numbers indicating greater quality of life."|Week 104|Intent-to-treat who completed Week 104 and had SF-36 data available.||Score||Standard Deviation|Mean
778196|NCT00774852|Secondary|Lupus Disease Activity – Patient Global Assessment Percent Change From Baseline|"Lupus disease activity was assessed by 7 different measures: anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment (PGA), SF36 total scores, and BILAG-2004 scores.
PGA is measured on a 100mm scale and assessed at Weeks 0, 12, 24, 52, and 104. Higher values indicate greater burden of disease."|Week 104|Intent-to-treat who completed Week 104 and had patient global assessment data available.||percent change||Standard Deviation|Mean
778197|NCT00774852|Secondary|Lupus Disease Activity – Patient Global Assessment|"Lupus disease activity was assessed by 7 different measures: anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment (PGA), SF36 total scores, and BILAG-2004 scores.
PGA is measured on a 100mm scale and assessed at Weeks 0, 12, 24, 52, and 104. Higher values indicate greater burden of disease."|Week 104|Intent-to-treat who completed Week 104 and had patient global assessment data available.||units on a scale||Standard Deviation|Mean
778198|NCT00774852|Secondary|Lupus Disease Activity – Frequency of Flares|"Lupus disease activity was assessed by 7 different measures: anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment, SF36 total scores, and BILAG-2004 scores.
Flares can be renal or non-renal. A renal flare is defined as two successive evaluations at least 1 week apart as proteinuria >1 gm/24h for participants who attain a complete response at Week 12 and for all other participants either 1) Increasing serum creatinine and persistent proteinuria, or 2) Worsening proteinuria. A non-renal flare is defined as any new post-baseline BILAG A in a non-renal organ system using BILAG-2004. This outcome measures the number of participants with the presence of renal and non-renal flares from Week 24 through Week 52 by response status. Having flares is indicative of more lupus disease activity."|Week 52|Intent-to-treat with available data between weeks 24 and 52.||participants|||Number
778242|NCT00775021|Secondary|Inferior Region Corneal Staining|The investigator assessed abrasion to the lower portion of the cornea using the following scale:0 = None 1 = Slight micropunctate (1-10 spots) 2 = Moderate micropunctate (11-20 spots) 3 = Severe micropunctate (>20 spots)4 = Slight macropunctate (1-5 spots) 5 = Moderate macropuntate (>5-10 spots) 6 = Severe macropunctate (>10 spots) 7 = Slight patch (1-2mm)8 = Moderate patch (>2-4mm) 9 = Severe patch (>4mm)|1 week|Analysis includes all participants that completed the study.||units on a scale||Standard Error|Least Squares Mean
778199|NCT00774852|Secondary|Lupus Disease Activity – Presence of Hypocomplementemia|"Lupus disease activity was assessed by 7 different measures: anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment, SF36 total scores, and BILAG-2004 scores.
Participants were categorized as having hypocomplementemia if their serum complement test results (C3, and C4) were below the normal range at the site. Below normal complement test results are indicative of active lupus erythematosus."|Week 104|Intent-to-treat participants who completed Week 104 and had hypocomplementemia data available||participants|||Number
778200|NCT00774852|Secondary|Lupus Disease Activity – Negative Anti-dsDNA|"Lupus disease activity was assessed by 7 different measures: reduction in anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment, SF36 total scores, and BILAG-2004 scores.
Participants with systemic lupus erythematosus (SLE) may have autoantibodies (e.g., self against self) to double-stranded DNA. Double-stranded DNA is one of multiple diagnostic tests for SLE and levels may be associated with disease activity. This measure was the number of participants who had negative anti-dsDNA at Week 104. Having a negative score is indicative of low lupus disease activity."|Week 104|Intent-to-treat participants who completed Week 104.||participants|||Number
778201|NCT00774852|Secondary|Lupus Disease Activity – Participants Who Were Anti-dsDNA Positive at Baseline and Negative at Week 104|"Lupus disease activity was assessed by 7 different measures: reduction in anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment, SF36 total scores, and BILAG-2004 scores.
Participants with systemic lupus erythematosus (SLE) may have autoantibodies (e.g., self against self) to double-stranded DNA. Double-stranded DNA is one of multiple diagnostic tests for SLE and levels may be associated with disease activity. One measure used to assess disease activity is the number of participants who were anti-dsDNA positive at baseline but negative at Week 104. Going from positive to negative is indicative of lowered lupus activity."|Week 104|Participants from Intent-to-treat population who had positive anti-dsDNA at baseline and completed Week 104.||participants|||Number
778202|NCT00774852|Secondary|Number of Participants Who Achieved No Response at 24 Weeks and Continued in the Study , Achieving a Complete or Partial Response|A participant who did not meet the criteria for either a complete response (CR) or a partial response (PR) at Week 24 was considered a non-responder. After Week 24, non-responders were terminated from the study and treated according to best clinical judgment unless the investigator judged that the participant may benefit from continued participation. CR definition: a serum creatinine <= 1.2 mg/dL or <=125% of the higher value at either screening or baseline visit, protein-to-creatinine ratio <0.5, and prednisone dose tapered to <=10 mg/day or prednisone dosing allowances in protocol. Participants had to meet all of the referenced criteria to be considered a CR. PR definition: a serum creatinine <= 1.2 mg/dL or <= to 125% of the higher value at either screening or baseline, and improvement (reduction) >= to 50% in the urine protein to creatinine ratio at either screening or baseline, and prednisone dose has been tapered to 10 mg/day.|Week 52|Intent-to-treat|||||
778203|NCT00774852|Secondary|Number of Participants Who Achieved No Response at 24 Weeks and Continued in the Study|A participant who did not meet the criteria for either a complete response or a partial response at Week 24 was considered a non-responder. After Week 24, non-responders were terminated from the study and treated according to best clinical judgment unless the site investigator judged that the participant could benefit from continued participation. Non responders did not respond to treatment and lupus activity is moderate to severe.|Week 104|Intent-to-treat||participants|||Number
778204|NCT00774852|Secondary|Number of Participants Fulfilling the Proteinuria and Prednisone Criteria of a Partial Response|A partial proteinuria and prednisone response is defined as an improvement (reduction) of >=50% in the urine protein-to-creatinine ratio at either visit -1 or 0, and prednisone dose has been tapered to 10 mg/day. Subjects who discontinued treatment or terminated from the study in the first 24 weeks are defined as response failures for all subsequent visits. Partial responders are those who showed some response to treatment and low activity of their lupus nephritis.|Week 24|Intent-to-treat||participants|||Number
778205|NCT00774852|Secondary|Number of Participants Fulfilling the Proteinuria and Prednisone Criteria of a Complete Response|A complete proteinuria and prednisone response is defined as urine protein-to-creatinine ratio <0.5 and prednisone dose tapered to <= 10mg/day. Subjects who discontinued treatment or terminated from the study in the first 24 weeks are defined as response failures for all subsequent visits. Complete responders are those who successfully responded to treatment and have minimal activity of their lupus nephritis.|Week 24|Intent-to-treat||participants|||Number
778206|NCT00774852|Secondary|Number of Participants Who Achieved a Complete Response by Week 24 and Maintained the Complete Response Through Week 52|Complete response definition: a serum creatinine <= 1.2 mg/dL or <=125% of the higher value at either screening or baseline visit, protein-to-creatinine ratio <0.5, and prednisone dose tapered to <=10 mg/day or prednisone dosing allowances in protocol. Participants had to meet all of the referenced criteria to be considered a complete responder (CR). Participants who discontinued treatment and/or terminated from the study were defined as response failures for all subsequent visits. CRs are those who successfully responded to treatment and had minimal activity of their lupus nephritis.|Week 52|Intent-to-treat||participants|||Number
778207|NCT00774852|Secondary|Number of Participants With a Complete or Partial Response|"Complete response: a serum creatinine <= 1.2 mg/dL or <=125% of the higher value at either screening or baseline visit, protein-to-creatinine ratio <0.5, and prednisone dose tapered to <=10 mg/day or prednisone dosing allowances in protocol. Participants had to meet all of the referenced criteria to be considered a complete responder.
Partial response: a serum creatinine <= 1.2 mg/dL or <= to 125% of the higher value at either screening or baseline visit, and improvement >= to 50% in the urine protein to creatinine ratio at either screening or baseline visit, and prednisone dose has been tapered to 10 mg/day or according to protocol dosing allowances in protocol.
Participants who discontinued treatment and/or terminated from the study were defined as response failures for all subsequent visits. CRs successfully responded to treatment and have minimal activity of their lupus nephritis. Partial responders showed some response to treatment and low activity of their lupus nephritis."|Week 52|Intent-to-treat||participants|||Number
778243|NCT00775021|Primary|Overall Comfort|Subjects rated study contact lens for overall comfort using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.|1 week|Analysis includes all participants that completed the study.||units on a scale||Standard Error|Least Squares Mean
778208|NCT00774852|Secondary|Number of Participants With Partial Response|Outcome measure description: Partial response definition: a serum creatinine <= 1.2 mg/dL or <= to 125% of the higher value at either screening or baseline visit, and improvement (reduction) >= to 50% in the urine protein to creatinine ratio at either screening or baseline visit, and prednisone dose has been tapered to 10 mg/day or according to protocol dosing allowances in protocol. Participants who discontinued treatment and/or terminated from the study in the first 24 weeks were defined as complete response failures for all subsequent visits. Partial responders are those who showed some response to treatment and low activity of their lupus nephritis.|Week 24|Intent-to-treat||participants|||Number
778209|NCT00774852|Primary|Number of Participants With Complete Response|Complete response definition: a serum creatinine <= 1.2 mg/dL or <=125% of the higher value at either screening or baseline visit, protein-to-creatinine ratio <0.5, and prednisone dose tapered to <=10 mg/day or prednisone dosing allowances in protocol. Participants had to meet all of the referenced criteria to be considered a complete responder (CR). Participants who discontinued treatment and/or terminated from the study in the first 24 weeks were defined as CR failures for all subsequent visits. CRs are those who successfully responded to treatment and have minimal activity of their lupus nephritis.|Week 24|Intent-to-treat||participants|||Number
778210|NCT00774930|Secondary|Absolute Changes From Baseline in Biochemical Markers (Urinary 5-hydroxyindoleacetic Acid [5-HIAA])|Baseline is defined as the last non-missing observation obtained prior to the initiation of study treatment.|Baseline and Week 12 of DB phase|ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group); n=number of subjects taken into account for the analysis. Only the observed data are used in the calculation. The missing data are excluded from the analysis.||μmol/day||Standard Deviation|Mean
778211|NCT00774930|Secondary|Absolute Changes From Baseline in Biochemical Markers (Plasma Chromogranin A [CgA])|Baseline is defined as the last non-missing observation obtained prior to the initiation of study treatment.|Baseline and Week 12 of DB phase|ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group); n=number of subjects taken into account for the analysis. Only the observed data are used in the calculation. The missing data are excluded from the analysis.||μg/L||Standard Deviation|Mean
778212|NCT00774930|Secondary|Changes From Baseline in QoL in “Endocrine Symptoms” Subscore (Assessed Based on Items Q31, Q32 and Q33 Using EORTC QLQ-G.I.NET-21 Questionnaires)|"Baseline is defined as the last non-missing observation obtained prior to the initiation of study treatment.
The QLQ-G.I.NET21 questionnaire contains 21 single items (Q31 to Q51) which are supplemental items to the EORTC QLQ-C30 questionnaire. Q31 to Q51 range from 1 to 4 with 1 being the most favourable answer and 4 the worst case (1 = Not at all, 2 = A little, 3 = Quite a bit, 4 = Very much). Based on these items the scores were generated. All of the scores range in score from 0 to 100. A high score for a symptom scale represents a high level of symptomatology. The principle for scoring the scale is: Estimate the average of the items (I1, I2, ..., In) that contribute to the scale; this is the raw score. RS = (I1 + I2 +…+ In)/n.
For symptom scales: Score = {(RS - 1)/range} x 100, where range is the difference between the maximum possible value of RS and the minimum possible value of RS."|Baseline and Week 12 of DB phase|ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group); n=number of subjects taken into account for the analysis. Only the observed data are used in the calculation. The missing data are excluded from the analysis.||Units on a scale||Standard Deviation|Mean
778213|NCT00774930|Secondary|Changes From Baseline in “Gastrointestinal (G.I). Symptoms” Subscore (Based on Items Q34, Q35, Q36, Q37 and Q38 of EORTC G.I. Neuroendocrine Tumour [NET] 21]|"Baseline is defined as the last non-missing observation obtained prior to the initiation of study treatment.
The QLQ-G.I.NET21 questionnaire contains 21 single items (Q31 to Q51) which are supplemental items to the EORTC QLQ-C30 questionnaire. Q31 to Q51 range from 1 to 4 with 1 being the most favourable answer and 4 the worst case (1 = Not at all, 2 = A little, 3 = Quite a bit, 4 = Very much). Based on these items the scores were generated. All of the scores range in score from 0 to 100. A high score for a symptom scale represents a high level of symptomatology. The principle for scoring the scale is: Estimate the average of the items (I1, I2, ..., In) that contribute to the scale; this is the raw score. RS = (I1 + I2 +…+ In)/n.
For symptom scales: Score = {(RS - 1)/range} x 100, where range is the difference between the maximum possible value of RS and the minimum possible value of RS."|Baseline and Week 12 of DB phase|ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group); n=number of subjects taken into account for the analysis. Only the observed data are used in the calculation. The missing data are excluded from the analysis.||Units on a scale||Standard Deviation|Mean
778214|NCT00774930|Secondary|"Changes From Baseline in Global Health Status/Quality of Life (QoL) Score (Based on Items 29 and 30 of the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire [EORTC-QLQ] C30)"|"Baseline is defined as the last non-missing observation obtained prior to the initiation of study treatment.
Q29 and Q30 range from 1 (Very poor) to 7 (Excellent) with 1 being worst case and 7 the most favourable answer. Scores were derived according to the rules contained within the EORTC scoring manual. All of the scores range in score from 0 to 100. A high score for global health status/QoL represents high QoL. The principle for scoring the scale is: Estimate the average of the items (I1, I2, ..., In) that contribute to the scale; this is the raw score. Raw score = RS = (I1 + I2 +…+ In)/n.
For global health status/QoL: Score = {(RS - 1)/range} x 100, where range is the difference between the maximum possible value of RS and the minimum possible value of RS."|Baseline and Week 12 of DB phase|ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group); n=number of subjects taken into account for the analysis. Only the observed data are used in the calculation. The missing data are excluded from the analysis.||Units on a scale||Standard Deviation|Mean
778215|NCT00774930|Secondary|Proportion of Subjects Who Rolled Over Into the IOL Phase Before Completing the DB Phase of the Study|Subjects who rolled over early were those who received less than four DB injections before receiving the first IOL injection.|16-week DB phase|ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group). Subjects from the ITT population were analysed under the randomised treatment group.||Percentage of subjects|||Number
778244|NCT00775190|Secondary|Side Effects (Incidence of Thromboembolic Events)|Occurrence of any thromboembolic events during the study time frame.|6 months|Study Terminated with no data analysis|||||
778216|NCT00774930|Secondary|Percentage of Days of Use of Other Rescue Medication|Usage of other concomitant rescue medications for diarrhoea and/or flushing events, measured as the percentage of days that the medications were used as rescue medication based on subject IVRS/IWRS diary records. Subjects were required to record the use and dose of s.c. octreotide, if any, as well as the use of other concomitant rescue medications (e.g. loperamide 2 mg tabs, and/or tincture of opium).|16-week DB phase|ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group). Subjects from the ITT population were analysed under the randomised treatment group.||Percentage of days||Standard Deviation|Mean
778217|NCT00774930|Secondary|Average Frequency of Flushing Events (Per Day) Based on Subject Diary Records.||16-week DB phase|ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group). Subjects from the ITT population were analysed under the randomised treatment group.||Number of events per day||Standard Deviation|Mean
778218|NCT00774930|Secondary|Average Frequency of Diarrhoea Events (Per Day) Based on Subject Diary Records.||16-week DB phase|ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group). Subjects from the ITT population were analysed under the randomised treatment group.||Number of events per day||Standard Deviation|Mean
778219|NCT00774930|Primary|Percentage of Days With Subcutaneous Octreotide as Rescue Medication|Use of s.c. octreotide required to control symptoms associated with carcinoid syndrome, measured as the percentage of days that s.c. octreotide was used as rescue medication, based on subject Interactive Voice Response System (IVRS) or Interactive Web Response System (IWRS) diary records.|16-week DB phase|ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group). Subjects from the ITT population were analysed under the randomised treatment group.||Percentage of days||95% Confidence Interval|Least Squares Mean
778220|NCT00769314|Secondary|Patient Assessment of Efficacy of the Treatment|At the end of study (Day 14 [ or within 24 hours of healing]), patients were asked to rate efficacy of treatment using a 4-point scale (inactive, mildly active, moderately active, or very active).|Assessed on Day 14 (or within 24 hours of healing)|This endpoint was analyzed using the ITT population.||participants|||Number
778221|NCT00769314|Secondary|Patient Satisfaction With Treatment|At the end of study (Day 14 [or within 24 hours of healing]), patients were asked whether they were satisfied with treatment (yes/no).|Assessed on Day 14 (or within 24 hours of healing)|This endpoint was analyzed using the ITT population.||participants|||Number
778222|NCT00769314|Secondary|Symptom Intensity (Visual Analogue Scale [VAS])|"Patients were asked to place a tick mark on a 10 centimeter VAS indicating their symptom intensity. Scale ratings ranged from a minimum of 0 (none at all) to a maximum of 10 (worst possible). The location of the tick mark from 0 was measured in millimeters (0 - 100) and recorded."|Assessed on Days 1, 3, 5, 7 and 14 (or within 24 hours of healing)|This endpoint was analyzed using the safety population, which consisted of all randomized patients who took at least 1 dose of study medication.||units on a scale (0 - 100)||Standard Deviation|Mean
778223|NCT00769314|Secondary|Patient Incidence of Recurrence of Non-aborted Lesions During 9-month Follow-up|Recurrence was the occurrence of new lesions and was evaluated in a subgroup of patients who agreed to record recurrences during the 9-month follow-up period.|From time of initial healing through the 9-month follow-up|This endpoint was analyzed using the follow-up population, a subgroup of the ITT population who continued to the 9 month follow-up and had at least 1 diary assessment during that period. The follow-up population was defined as patients whose lesions were healed at the end of Day 14 and had no recurrence within 15 days of healing of all lesions.||participants|||Number
778224|NCT00769314|Secondary|Time to Recurrence of Non-aborted Lesions During 9-month Follow-up|Time to recurrence was the time from the healing of all lesions of the initial episode to the occurrence of new lesions.|From time of initial healing through the 9-month follow-up|This endpoint was analyzed using the follow-up population, a subgroup of the ITT population who continued to the 9 month follow-up and had at least 1 diary assessment during that period. The follow-up population was defined as patients whose lesions were healed at the end of Day 14 and had no recurrence within 15 days of healing of all lesions.||Days||95% Confidence Interval|Median
778225|NCT00769314|Primary|Time to Healing (TTH) of Vesicular Primary Lesion|Healing was defined as the loss of crust (erythema may be present) as assessed by the investigator. TTH was the time from treatment initiation to healing as defined above and was assessed from the time of treatment initiation through Day 14. The primary vesicular lesion was the first developed lesion located on the lip and was not to have extended more than 1 cm outside the lip.|Assessed from time of treatment initiation through Day 14|The modified Intent-to-Treat (mITT) population was the population used for analysis of this endpoint. The mITT population included all randomized patients who received at least one dose of study medication and who reached the vesicular stage (ie, episodes that progressed through macula, papule, vesicle, crust and healing).||Days||95% Confidence Interval|Median
778226|NCT00769314|Secondary|TTH of Aborted Primary Lesions|TTH of aborted primary lesions was defined as the time from treatment initiation to healing of the primary lesion (erythema or papule) or cessation of symptoms, whichever came last. It was to be assessed by the investigator.|Assessed from time of treatment initiation through Day 14|This endpoint was analyzed using the subgroup of patients within the ITT population with aborted lesions.||Days||95% Confidence Interval|Median
778227|NCT00769314|Secondary|Time to Cessation of Symptoms|Time to cessation of symptoms was defined as the time from treatment initiation to cessation of all symptoms: pain, burning, itching, tingling, tenderness and discomfort. It was to be assessed by the investigator.|Assessed from time of treatment initiation through Day 14|This endpoint was analyzed using the ITT population.||Days||95% Confidence Interval|Median
778228|NCT00769314|Secondary|Duration of Episode (DOE)|For patients who experienced a vesicular lesion, DOE was defined as the time from treatment initiation to healing of primary and secondary vesicular lesions (loss of crust). For subjects whose primary and secondary lesions were not vesicular in nature, DOE was defied as the time from treatment initiation to return to normal skin or to cessation of symptoms, whichever came last.|Assessed from initiation of treatment to Day 14|This endpoint was analyzed using the ITT population.||Days||95% Confidence Interval|Median
778245|NCT00775190|Secondary|Side Effects (Menstrual Cramps)|Intensity of menstrual cramps reported on a 4 point Likert scale.|6 months|Study Terminated with no data analysis|||||
778229|NCT00769314|Secondary|TTH of Non-primary Lesions (Aborted Lesions Excluded)|TTH of non-primary lesions was defined as the time from treatment initiation to healing of all non-primary vesicular lesions. Non-primary lesions were those that developed in addition to and/or in 1 or more days after the primary vesicular lesion and that were located at least 1 cm from the primary lesion. Aborted lesions were not included in this parameter. TTH was to be assessed by the investigator.|Assessed from the time of treatment initiation through Day 14|This endpoint was analyzed using a subgroup of patients in the ITT population with non-primary lesions.||Days||95% Confidence Interval|Median
778230|NCT00769314|Secondary|Abortion of Primary Lesions|Aborted lesions were defined as herpetic lesions preceded by prodromal symptoms that did not progress beyond the papule stage.|Assessed from the time of treatment initiation through Day 14|This endpoint was analyzed using the Intent-to-Treat (ITT) population, which consisted of all randomized patients who received at least one dose of study medication and who had complete information recorded for the application time.||participants|||Number
778231|NCT00774995|Secondary|Number of Subjects That Experienced Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the entire study period after the challenge dose (1 month).|||Subjects|||Number
778232|NCT00774995|Secondary|Number of Subjects Experiencing Any, Grade 3 and Related to Vaccination Unsolicited Symptoms.|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Grade 3 symptom is any event that prevented normal activities. Related symptom is an event that was considered by investigator as causally related to the study vaccination.|During the 31-day follow-up period after the hepatitis B vaccine challenge dose.|||Subjects|||Number
778233|NCT00774995|Primary|Number of Subjects With an Anamnestic Response to a Challenge Dose of Hepatitis B Virus (HBV) Vaccine as Measured by ChemiLuminescence ImmunoAssay (CLIA).|Anamnestic response to the challenge dose is defined as: - At least (i.e. greater than or equal to) a 4-fold rise in post-challenge anti-HBsAg antibody concentrations in subjects seropositive at the last available follow-up time-point. -Post-challenge dose anti-HBsAg antibody concentrations >= 10 mIU/mL in subjects seronegative at the last available follow-up time-point.|One month after the hepatitis B vaccine challenge dose.|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received the challenge dose of HBV vaccine and for whom data concerning immunogenicity measures were available at the post-HBV vaccine challenge dose time point.||Subjects|||Number
778234|NCT00774995|Secondary|Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by CLIA.|Concentrations given as GMC expressed as milli-international unit per millilitre (mIU/mL).|One month after the hepatitis B vaccine challenge dose.|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received the challenge dose of HBV vaccine and for whom data concerning immunogenicity measures were available at the post-HBV vaccine challenge dose time point.||mIU/mL||95% Confidence Interval|Geometric Mean
778235|NCT00774995|Secondary|Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by ELISA.|Concentrations given as GMC expressed as milli-international unit per millilitre (mIU/mL).|One month after the hepatitis B vaccine challenge dose.|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received the challenge dose of HBV vaccine and for whom data concerning immunogenicity measures were available at the post-HBV vaccine challenge dose time point.||mIU/mL||95% Confidence Interval|Geometric Mean
778236|NCT00774995|Secondary|Number of Subjects With Anti-Hepatitis B Surface (HBs) Antibody Concentrations Above Cut-off Values as Measured by CLIA.|Cut-off values assessed were as follows: ≥6.2 milli-international units/milliliter (mIU/mL), ≥10 mIU/mL, ≥100 mIU/mL|One month after the hepatitis B vaccine challenge dose.|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received the challenge dose of HBV vaccine and for whom data concerning immunogenicity measures were available at the post-HBV vaccine challenge dose time point.||Subjects|||Number
778237|NCT00774995|Secondary|Number of Subjects With Anti-Hepatitis B Surface (HBs) Antibody Concentrations Above Cut-off Values as Measured by ELISA.|Cut-off values assessed were as follows: ≥3.3 milli-international units/milliliter (mIU/mL), ≥10 mIU/mL, ≥100 mIU/mL|One month after the hepatitis B vaccine challenge dose.|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received the challenge dose of HBV vaccine and for whom data concerning immunogenicity measures were available at the post-HBV vaccine challenge dose time point.||Subjects|||Number
778238|NCT00774995|Primary|Number of Subjects With an Anamnestic Response to a Challenge Dose of Hepatitis B Virus (HBV) Vaccine as Measured by Enzyme-Linked Immunosorbent Assay (ELISA).|Anamnestic response to the challenge dose is defined as: - At least (i.e. greater than or equal to) a 4-fold rise in post-challenge anti-HBsAg antibody concentrations in subjects seropositive at the last available follow-up time-point. -Post-challenge dose anti-HBsAg antibody concentrations >= 10 mIU/mL in subjects seronegative at the last available follow-up time-point.|One month after the hepatitis B vaccine challenge dose.|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received the challenge dose of HBV vaccine and for whom data concerning immunogenicity measures were available at the post-HBV vaccine challenge dose time point.||Subjects|||Number
778239|NCT00775021|Secondary|Overall Lens Handling|Subjects rated study contact lens for overall ease of handling using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.|1 week|Analysis includes all participants that completed the study.||units on a scale||Standard Error|Least Squares Mean
778240|NCT00775021|Secondary|Initial Comfort|Subjects rated study contact lens for comfort immediately when they first put the lenses on using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.|1 Week|Analysis includes all participants that completed the study.||units on a scale||Standard Error|Least Squares Mean
778241|NCT00775021|Secondary|End of the Day Comfort|Subjects rated study contact lens comfort at the end of a day of lens wear using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.|1 week|Analysis includes all participants that completed the study.||units on a scale||Standard Error|Least Squares Mean
778254|NCT00775203|Secondary|Awakening During the Night at Each Visit|"Awakening during the night was measured on a 4-point rating scale ranging from 1 = never to 4 = always in response to the question: Since the last study visit did you awaken during the night?."|Weeks 1, 2, 3, 4, 6, 8|Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. Last Observation Carried Forward (LOCF).||Units on a scale||Standard Deviation|Mean
778255|NCT00775203|Secondary|Trouble Falling Asleep at Each Visit|"Trouble Falling Asleep was measured on a 4-point rating scale ranging from 1 = never to 4 = always in response to the question: Since the last study visit, how often did you experience trouble falling asleep?."|Weeks 1, 2, 3, 4, 6, 8|Full Analysis set (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. Last Observation Carried Forward (LOCF).||Units on a scale||Standard Deviation|Mean
778256|NCT00775203|Secondary|Overall Quality of Sleep at Each Visit|"Overall Quality of Sleep was measured on a 4-point rating scale ranging from 1 = very poor to 4 = excellent in response to the question: Since the last study visit, how would you rate the overall quality of your sleep?."|Weeks 1, 2, 3, 4, 6, 8|Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. Last Observation Carried Forward (LOCF).||Points on a scale||Standard Deviation|Mean
778257|NCT00775203|Secondary|Patient Global Impression – Improvement of Illness (PGI-I) Responders at Last Study Visit|Patients were responders if the PGI-I rating was “Much Improved” or “Very Much Improved”. The PGI-Improvement of Illness (PGI-I) consists of one question for the patient: “Since the start of the study, my overall status with regard to depression is?” which is rated on the following seven-point scale 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6= much worse; 7=very much worse. Results are expressed in number of patients.|Week 8|Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. PGI-I Responders Week 8 Observed Cases: Trazodone = 176, placebo = 183.||participants|||Number
778258|NCT00775203|Secondary|Clinical Global Impression – Improvement of Illness (CGI-I) Responders at Last Study Visit|Patients were responders if the CGI-I rating was “Much Improved” or “Very Much Improved”. The CGI-Improvement of Illness (CGI-I) consists of one question for the investigator: “Compared to his condition at the start of the study, how much has this patient changed?” which is rated on the following seven-point scale 1=very much improved; 2=much improved; 3=minimally improved; 4=no change from baseline; 5=minimally worse; 6= much worse; 7=very much worse. Results are expressed in number of patients.|Week 8|Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. CGI-I Responders Week 8 Observed Cases: Trazodone = 180, placebo = 183.||participants|||Number
778259|NCT00775203|Secondary|Patient Global Impression – Improvement of Illness (PGI-I) Score at Last Study Visit|The PGI-Improvement of Illness (PGI-I) consists of one question for the patient: “Since the start of the study, my overall status with regard to depression is?” which is rated on the following seven-point scale 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6= much worse; 7=very much worse.|Week 8|Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. PGI-I Week 8 Observed Cases: Trazodone = 176, placebo = 183.||Units on PGI-I scale||Standard Deviation|Mean
778260|NCT00775203|Secondary|Clinical Global Impression – Improvement of Illness (CGI-I) Score at Last Study Visit|The CGI-Improvement of Illness (CGI-I) consists of one question for the investigator: “Compared to his condition at the start of the study, how much has this patient changed?” which is rated on the following seven-point scale 1=very much improved; 2=much improved; 3=minimally improved; 4=no change from baseline; 5=minimally worse; 6= much worse; 7=very much worse.|Week 8|Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. CGI-I Week 8 Observed Cases: Trazodone = 178, placebo = 182.||Units on the CGI-I scale||Standard Deviation|Mean
778261|NCT00775203|Secondary|Change From Baseline in Clinical Global Impression of Severity (CGI-S) to Each Visit|The CGI-Severity (CGI-S) consists of one question for the investigator: “Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?” which is rated on the following seven-point scale: 1=normal, not ill at all; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients.|Baseline to Weeks 1, 2, 3, 4, 6, 8|Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. Last Observation Carried Forward (LOCF).||Units on CGI-S scale||Standard Deviation|Mean
778262|NCT00775203|Secondary|Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score From Baseline|The Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10 item clinician-administered depression rating scale. The 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts) are rated on a scale ranging from 0 (low severity/difficulty) to 6 (high severity/difficulty) with anchors at 2-point intervals. The overall total score range is from 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline to Week 8|Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. MADRS Week 8 Observed Cases: Trazodone = 178, placebo = 182.||Units on MADRS scale||Standard Deviation|Mean
778263|NCT00775203|Secondary|Change in HAMD-17 Depressed Mood Item (Item 1) Score From Baseline to Each Visit|Change from baseline in the HAMD-17, item 1: Depressed Mood item, at each post-baseline visit. The Depressed Mood item is rated on a 5-point scale ranging from rating of 0=absent; to 4=very severe.|Baseline to Weeks 1, 2, 3, 4, 6, 8|Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. Last Observation Carried Forward (LOCF).||Points on the HAMD scale||Standard Deviation|Mean
778265|NCT00775203|Secondary|HAMD-17 Responders at Each Visit|Number of patients who show a response (defined as at least a 50% reduction from baseline in HAMD-17 score) at each post-baseline visit.|Weeks 1, 2, 3, 4, 6, 8|Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. Last Observation Carried Forward (LOCF).||Participants|||Number
778266|NCT00775203|Primary|Change in Hamilton Depression Scale (HAMD-17) Total Score From Baseline|The Hamilton Depression Rating Scale 17 items [HAMD-17] is a 17-item scale that evaluates depressed mood, vegetative and cognitive symptoms of depression, and co-morbid anxiety symptoms. The 17 items are rated on either a 5-point (0-4) or a 3-point (0-2) scale. In general, the 5 point scale items use a rating of 0=absent; 1=doubtful to mild; 2=mild to moderate; 3=moderate to severe; 4=very severe. The 3-point scale items use a rating of 0=absent; 1=probable or mild; 2=definite. The total HAMD-17score ranges from 0 (not ill) to 52 (severely ill).|Baseline to Week 8|Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. Week 8 Last Observation Carried Forward (LOCF): Trazodone = 202, placebo = 204.||Points on HAMD-17 scale||Standard Deviation|Mean
778267|NCT00775229|Secondary|Liver Function Tests|Participants were administered a general test of liver functioning to asses safety over the course of the study. Data represent the percentage of participates with Liver Function Test values falling outside of the range considered safe/typical for liver functioning at any of the assessed time points. It was performed at baseline and at each visit where dosage of the medication is >50mg/day (week 2-week 8).|Week 8 (last visit)|||percentage of individuals with LFT chang|||Number
778268|NCT00775229|Secondary|Massachusetts General Hospital Hairpulling Scale|Ranges from 0-28 with 28 being the most severe. The lower the total score, the lower the severity level. This scale is given and measured once every 2 weeks for a total of 8 weeks. The final total score is reported here.|This is the final score, measured at week 8 (final visit).|||units on a scale||Standard Deviation|Mean
778269|NCT00775229|Primary|National Institute of Mental Health Trichotillomania Symptom Severity Scale|Ranges from 0-20 with 20 being the most severe. The lower the total score, the lower the severity level. This scale is given and measured once every 2 weeks for a total of 8 weeks. The final total score is reported here.|This is the final score, measured at week 8 (final visit).|||units on a scale||Standard Deviation|Mean
778270|NCT00775944|Secondary|Use of Other NHS Smoking Cessation Interventions (e.g. Uptake of NHS Stop Smoking Services, Use of Other NRT Obtained From General Practitioner (GP) Etc.)|Participants' recall of the use they have made of other stop smoking interventions that are available through the National Health Service.|Measured 6 months after participant's quit date||||||
778271|NCT00775944|Secondary|Health Status at 6 Months EuroQol 5D (EQ5D)|This is a generic measure of health status used in health economic analyses.|Measured 6 months after participant's quit date||||||
778272|NCT00775944|Secondary|Number of Unsuccessful Quit Attempts Lasting > 24 Hrs Reported at One and 6 Months|As title|Measured 6 months after participant's quit date||||||
778273|NCT00775944|Secondary|Self-reported Point Prevalence Abstinence From Smoking for at Least 7 Days, Ascertained at 1 Month|Participants had to report not smoking for 7 or more days prior to outcome ascertainment.|Measured at 1 month after participant's quit date|All randomised cases||participants|||Number
778274|NCT00775944|Secondary|Self-reported Prolonged Abstinence From Smoking Between a Quit Date and 1 Month|Prolonged abstinence was defined as not smoking between a quit date and one month later; minor lapses were permitted provided no more than 5 cigarettes in total had been smoked.|Measured at 1 month after participant's quit date|All randomised cases||participants|||Number
778275|NCT00775944|Secondary|Self-reported Abstinence From Smoking for at Least Three Months, Ascertained at 6 Months|Participants had to report not smoking in the three months prior to outcome ascertainment.|Measured at 6 months after participant's quit date|All randomised cases||participants|||Number
778276|NCT00775944|Secondary|Self-reported Point Prevalence Abstinence From Smoking for at Least 7 Days, Ascertained at 6 Months, With Carbon Monoxide (CO) Validation.|The participant had to report not smoking for at least 7 days prior to the point of outcome assessment.|Measured 6 months after participant's quit date|||participants|||Number
778277|NCT00775944|Primary|Self-reported, Prolonged Abstinence From Smoking Between a Quit Date and 6 Months Afterwards.|Prolonged abstinence was defined as not smoking between a quit date and six months later with minor smoking lapses permitted as long as no more than 5 cigarettes in total were smoked during this period.|6 months from participant's quit date|All randomised cases||participants|||Number
778278|NCT00775983|Secondary|Participants Who Experienced Complications or Need for Additional Dilation|Any complications, or mechanical dilation required, for early second-trimester surgical abortions performed after cervical preparation with same-day Dilapan versus those performed after cervical preparation with overnight laminaria|Day of procedure|All patients who received a surgical abortion procedure were analyzed. Since three patients did not actually obtain an abortion within the study timeframe, we could not analyze their data, thus the analysis was per protocol.||participants|||Number
778279|NCT00775983|Primary|Procedure Time|Procedure time to complete early second-trimester dilation and evacuation (D&E)|Day of procedure|All patients who received a surgical abortion procedure were analyzed. Since three patients did not actually obtain an abortion within the study timeframe, we could not analyze their data, thus the analysis was per protocol.||minutes||Standard Error|Mean
778280|NCT00776009|Secondary|Change From Pre-dose in the Permanent Product Measure of Performance of Measurement (PERMP) Math Test-Correctly Answered Score at 10, 11, and 12 Hours (Averaged) Post-dose|Permanent Product Measure of Performance of Measurement (PERMP) is an age-adjusted, paper-and-pencil math test consisting of 5 pages of 80 math problems each presented in ascending order of difficulty (requiring addition, subtraction, multiplication, and division computations, respectively) during a 10-minute time period. At the end of the 10-minute math test, papers are collected and scored; the number of problems attempted and the number of problems correctly answered are generated as objective measures related to “academic productivity.” A positive score indicates improvement.|Pre-dose to 10, 11, and 12 hours post-dose|Intent-to-treat population included all randomized patients who took at least 1 dose of study medication and who had at least 1 post-dose efficacy measurement.||Number correct||Standard Error|Least Squares Mean
778281|NCT00776009|Secondary|Change From Pre-dose in the Permanent Product Measure of Performance of Measurement (PERMP) Math Test-Attempted Score at 10, 11, and 12 Hours (Averaged) Post-dose|Permanent Product Measure of Performance of Measurement (PERMP) is an age-adjusted, paper-and-pencil math test consisting of 5 pages of 80 math problems each presented in ascending order of difficulty (requiring addition, subtraction, multiplication, and division computations, respectively) during a 10-minute time period. At the end of the 10-minute math test, papers are collected and scored; the number of problems attempted and the number of problems correctly answered are generated as objective measures related to “academic productivity.” A positive score indicates improvement.|Pre-dose to 10, 11, and 12 hours post-dose|Intent-to-treat population included all randomized patients who took at least 1 dose of study medication and who had at least 1 post-dose efficacy measurement||Number attempted||Standard Error|Least Squares Mean
778282|NCT00776009|Secondary|Change From Pre-dose in the Swanson, Kotkin, Agler, M Flynn, and Pelham (SKAMP) Deportment Score at 10, 11, and 12 Hour (Averaged) Post-dose|SKAMP is a 13-item rating scale consisting of 2 subscales (7-items for Attention and 6-items for Deportment) that measures classroom manifestations of ADHD. SKAMP was used to generate a score on the Deportment subscale at Hours 10, 11, and 12 on Day 7 of Weeks 1, 2, and 3. The rating scale is 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 36 for the Deportment subscale. The reported measure is the difference from baseline of the subscore averaged over Hours 10, 11, and 12. A negative score indicates improvement.|Pre-dose to 10, 11, and 12 hours post-dose|Intent-to-treat population included all randomized patients who took at least 1 dose of study medication and who had at least 1 post-dose efficacy measurement||Scores on a scale||Standard Error|Least Squares Mean
778283|NCT00776009|Secondary|Change From Pre-dose in the Swanson, Kotkin, Agler, M Flynn, and Pelham (SKAMP) Attention Score at 10, 11, and 12 Hour (Averaged) Post-dose|SKAMP is a 13-item rating scale consisting of 2 subscales (7-items for Attention and 6-items for Deportment) that measures classroom manifestations of ADHD. SKAMP was used to generate a score on the Attention subscale at Hours 10, 11, and 12 on Day 7 of Weeks 1, 2, and 3. The rating scale is 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 42 for the Attention subscale. The reported measure is the difference from baseline of the subscore averaged over Hours 10, 11, and 12. A negative score indicates improvement.|Pre-dose to 10, 11, and 12 hours post-dose|Intent-to-treat population included all randomized patients who took at least 1 dose of study medication and who had at least 1 post-dose efficacy measurement||Scores on a scale||Standard Error|Least Squares Mean
778284|NCT00776009|Primary|Change From Pre-dose in the Swanson, Kotkin, Agler, M Flynn, and Pelham (SKAMP) Combined Attention and Deportment Scores at 10, 11, and 12 Hour (Averaged) Post-dose|SKAMP is a 13-item rating scale that measures classroom manifestations of ADHD consisting of 2 subscales (7 items for Attention and 6 items for Deportment) used to generate a score at Hours 10, 11 and 12 on Day 7 of Weeks 1, 2 and 3. The ratings were based on both frequency and quality of specific behaviors. The rating scale is 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 78. The reported measure is the difference from baseline of the 2 combined subscores averaged over Hours 10, 11 and 12. A negative score indicates improvement.|Pre-dose to 10, 11, and 12 hours post-dose|Intent-to-treat population included all randomized patients who took at least 1 dose of study medication and who had at least 1 post-dose efficacy measurement||Scores on a scale||Standard Error|Least Squares Mean
778285|NCT00776100|Secondary|Duration of Response|Duration of response was defined for all evaluable patients who have achieved an objective response as the date at which the patient’s earliest best objective status was first noted to be either a complete response (CR) or partial response (PR) to the earliest date progression was documented.|Up to 5 years|Study terminated prematurely. Planned analyses was not performed. The data collected was not summarized in the data table due to the protected health information would specifically identify the study participants.|||||
778286|NCT00776100|Secondary|Time to Treatment Failure|Time to treatment failure was defined as the time from the date of randomization to the date at which the patient was removed from treatment (Arm II) or no treatment (Arm I) due to progression, adverse events, or refusal.|Up to 5 years|Study terminated prematurely. Planned analyses was not performed. The data collected was not summarized in the data table due to the protected health information would specifically identify the study participants.|||||
778287|NCT00776100|Secondary|Time to Disease Progression|Time to disease progression was defined as the time from randomization to the earliest date documentation of disease progression occurs. If a patient dies without a documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death.|Time from registration to disease progression (up to 5 years)|Study terminated prematurely. Planned analyses was not performed. The data collected was not summarized in the data table due to the protected health information would specifically identify the study participants.|||||
778288|NCT00776100|Secondary|Progression-free Survival|Progression-free survival was defined as the time from randomization to the first of either death due to any cause or progression.|Time from registration to disease progression or death (up to 5 years)|Study terminated prematurely. Planned analyses was not performed. The data collected was not summarized in the data table due to the protected health information would specifically identify the study participants.|||||
778289|NCT00776100|Secondary|Response Rate|A confirmed tumor response was defined as a complete response (CR) or partial response (PR) noted as the objective status on 2 consecutive evaluations around 3 months apart. All participants with measurable disease (non-CR at baseline, etc.), meeting the eligibility criteria who have signed a consent form and have started the study were evaluable for response.|Up to 5 years|Study terminated prematurely. Planned analyses was not performed. The data collected was not summarized in the data table due to the protected health information would specifically identify the study participants.|||||
778290|NCT00776100|Primary|Overall Survival|Overall survival was defined as the time from registration to the date of death or last follow-up|Time from registration to death or last follow-up (up to 5 years)|Study terminated prematurely. Planned analyses was not performed. The data collected was not summarized in the data table due to the protected health information would specifically identify the study participants.|||||
778291|NCT00776230|Secondary|Secondary: 1. Seroconversion Rate 2. GMTs Day 28, Month 6 and Month 12 3. Treatment Emergent Adverse Events 4. Systemic and Local Tolerability||see above||||||
778295|NCT00776555|Secondary|DRQ-S, Question 3|Question 3: Do you dislike the drug effect you are feeling now? Questions are rated on a 29-point scale from 1 (not at all) to 29 (an awful lot). The higher the score the stronger the subjective experience. This is a subjective measure of a drug's effect that has been used to assess the abuse potential of drugs.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12 and 24 hours post-dose|Analysis not performed because of the study's premature termination.|||||
778296|NCT00776555|Secondary|DRQ-S, Question 1|Question 1: How much do you feel the drug now? Questions are rated on a 29-point scale from 1 (not at all) to 29 (an awful lot). The higher the score the stronger the subjective experience. This is a subjective measure of a drug's effect that has been used to assess the abuse potential of drugs.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12 and 24 hours post-dose|Analysis not performed because of the study's premature termination.|||||
778297|NCT00776555|Primary|Drug Rating Questionnaire-Subject (DRQ-S), Question 2|Question 2: How much do you like the effects you are feeling now? Questions are rated on a 29-point scale from 1 (not at all) to 29 (an awful lot). The higher the score the stronger the subjective experience. This is a subjective measure of a drug's effect that has been used to assess the abuse potential of drugs.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12 and 24 hours post-dose|Analysis not performed because of the study's premature termination.|||||
778298|NCT00776594|Secondary|Analysis of Cytokines and Angiogenic Factors in Plasma/Serum|Analysis of cytokines and angiogenic factors in plasma/serum at baseline and at 6 months (end of treatment).|6 months|||pg/ml||Inter-Quartile Range|Median
778299|NCT00776594|Secondary|Cardiovascular Safety Including Measurement of Blood Pressure During Treatment Period (6 Months).|The number of patients who developed hypertension (greater that 150 systolic or greater than 90 diastolic) during treatment period.|6 months|||participants|||Number
778300|NCT00776594|Secondary|Number of Participants With PSA <0.2 ng/ml at Six Months|Number of participants with a PSA <0.2 ng/ml at six months (upon completion of treatment).|Six months (at completion of treatment)|||Number of participants|||Number
778301|NCT00776594|Primary|Relapse-free Survival|To identify a difference in relapse-free survival in men treated with short course ADT (6 months) versus short course ADT plus bevacizumab.|2 years|||months||95% Confidence Interval|Median
778302|NCT00776659|Primary|Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24, 30, 36 and 42||Baseline, Month 6, 12, 18, 24, 30, 36, 42|Results for this outcome were not reported because change from baseline in BMD could not be calculated as no participant had data available at more than 1 time point.|||||
778303|NCT00776659|Primary|Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C), Low Density Lipoprotein-Cholesterol (LDL-C), Total Cholesterol and Triglycerides at Month 6, 12, 18, 24, 30, 36 and 42||Baseline, Month 6, 12, 18, 24, 30, 36, 42|Results for this outcome were not reported because change from baseline in HDL-C, LDL-C, total cholesterol and triglycerides could not be calculated as no participant had data available at more than 1 time point.|||||
778304|NCT00776659|Primary|Number of Participants With Gynecological, Cardiac, Thromboembolic, Musculoskeletal and Menopausal Adverse Events (AEs)|An AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Number of participants with AEs related to gynecological, cardiac, venous thromboembolic, musculoskeletal and menopausal symptoms were reported. Gynecological AEs: bleeding, discharge, uterine dilatation and curettage; cardiac AEs: myocardial infarction, hypertension; musculoskeletal: joint stiffness, arthralgia, muscle cramps, fractures; menopausal symptoms: hot flushes, anxiety, depression, headache.|Baseline up to 28 days after last dose of study treatment|FAS included all enrolled participants who received at least 1 dose of aromasin therapy.||participants|||Number
778305|NCT00776659|Primary|Number of Participants Who Discontinued Aromasin Therapy||Baseline until discontinuation (up to Year 3.5)|FAS included all enrolled participants who received at least 1 dose of aromasin therapy.||participants|||Number
778306|NCT00776659|Primary|Number of Participants Who Died||Baseline until death (up to Year 3.5)|FAS included all enrolled participants who received at least 1 dose of aromasin therapy.||participants|||Number
778307|NCT00776659|Primary|Number of Participants With Appearance of Second Primary or Contralateral Breast Cancer||Baseline until appearance of second primary or contralateral breast cancer (up to Year 3.5)|FAS included all enrolled participants who received at least 1 dose of aromasin therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||participants|||Number
778308|NCT00776659|Primary|Number of Participants With Locoregional/Distant Recurrence of Primary Breast Cancer|Locoregional recurrence was defined as any recurrence of the breast cancer in the ipsilateral breast, chest wall or axillary lymph nodes.|Baseline until locoregional/distant recurrence of primary breast cancer (up to Year 3.5)|Full analysis set (FAS) included all enrolled participants who received at least 1 dose of aromasin therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||participants|||Number
778309|NCT00776789|Secondary|Breast Feeding Status at 6 Weeks|The mother was given a form at the time of birth of the baby for recording the duration of each breast feeding session and documentation of any supplemental feeds taken from the neonatal intensive care unit. The number and the amount of supplemental feeds was confirmed with the nursing staff on duty when in the hospital and with the mother at 6 weeks when she reported for the first vaccination or by telephonic contact with her at 6 weeks. This was recorded by the principal investigator and crosschecked by the second investigator in all cases|6 weeks|||percentage of partcipants|||Number
778310|NCT00776789|Secondary|Breast Feeding Status at 48 Hours|The mother was given a form at the time of birth of the baby for recording the duration of each breast feeding session and documentation of any supplemental feeds taken from the neonatal intensive care unit. The number and the amount of supplemental feeds was confirmed with the nursing staff on duty when in the hospital and with the mother at 6 weeks when she reported for the first vaccination or by telephonic contact with her at 6 weeks. This was recorded by the principal investigator and crosschecked by the second investigator in all cases.|48 hours|EBF rates were assessed using the standard WHO definitions. We asked the mothers about the method of feeding and the number and amount of supplemental feeds received in the first 2 days of life. Breastfeeding rates at 6 weeks were obtained by enquiring from the mothers at the time of the first vaccination of their infants in the follow-up clinic.||percentage of partcipants|||Number
778311|NCT00776789|Secondary|Salivary Cortisol|Saliva samples were collected with a Salivette. The infant had to suck on the swab for atleast 5 minutes. The prerequisite for collection of the saliva included that the infant should not have fed atleast 2 hours prior to the collection of the salivary sample. The filtrates were then transferred to a separate tube and were stored at 2-8º C for 24 hours. They were later transported to the central laboratory where the samples were stored at -20ºC and later analyzed using electrochemiluminescence immunoassay (ECLIA).|6 hours|||microgram/dl||Inter-Quartile Range|Median
778312|NCT00776789|Primary|The Median Breast Feeding Score|This was a one point assessment done at 36-48 hours by video recording. The video recording was carried out in a separate well lighted room after taking informed consent from the mother. The mother had full right to see the video and only if she was satisfied, was then the video finally stored. These videos were analyzed later using the infant breast feeding assessment tool : a scoring measure [0 to 3] for i) readiness to feed ii) sucking iii) rooting and iv) latching. The total possible score could vary from 0 to 12, with 12 being the best possible total score. Successful breastfeeding was defined as a total score of more >=8.|36-48 hours by video recording|||scores||Inter-Quartile Range|Median
778313|NCT00776919|Secondary|Number of Participants Reporting the Indicated Treatment-emergent Adverse Events (AEs) Resulting in Study Product Discontinuation|An AE included, but was not limited to, any clinically significant worsening of a pre-existing condition; an event occurring from overdose (i.e., a dose higher than that indicated in the protocol) of the study product, whether accidental or intentional; an event occurring from abuse (e.g., use for nonstudy reasons) of the study product; or an event that was associated with the discontinuation of the use of the study product.|Baseline (Day 1) through Week 12|ITT Population||participants|||Number
778314|NCT00776919|Secondary|Mean Duration of Study Product Use|Mean duration of study product use was calculated as the average total duration inclusive of missed applications of the study product.|Baseline (Day 1) through Week 12|ITT Population||days||Standard Deviation|Mean
778315|NCT00776919|Secondary|Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Itching and Burning/Stinging|Itching and burning/stinging (piercing pain) were evaluated independently by the investigator as: 0 (none)=normal, no discomfort; 1 (slight)=noticeable discomfort that caused intermittent awareness; 2 (moderate)=noticeable discomfort that caused intermittent awareness and interfered occasionally with normal daily activities; 3 (strong)=definite continuous discomfort that interfered with normal daily activities. Change from Baseline was calculated as the value at Weeks 2, 4, 8, and 12 minus the value at Baseline.|Baseline; Weeks 2, 4, 8, and 12|ITT Population. Only those participants with data available at both Baseline and the indicated assessment week were analyzed.||scores on a scale||Standard Deviation|Mean
778316|NCT00776919|Secondary|Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling|Erythema (Er, redness), dryness (Dr), and peeling (Pn), were evaluated independently by the investigator as: 0 (absent)=no Er, Dr, or Pn; 1 (slight)=faint red/pink coloration (col.), barely perceptible Dr with no flakes or fissure, mild localized Pn; 2 (mild)=light red/pink col., perceptible Dr with no flakes/fissure, mild and diffuse Pn; 3 (moderate)=medium red col., easily noted Dr and flakes but no fissure; 4 (severe)=beet red col., Dr with flakes and fissure, prominent dense Pn. Change from Baseline was calculated as the value at Weeks 2, 4, 8, and 12 minus the the value at Baseline.|Baseline; Weeks 2, 4, 8, and 12|ITT Population. Only those participants with data available at both Baseline and the indicated assessment week were analyzed.||scores on a scale||Standard Deviation|Mean
778317|NCT00776919|Secondary|Mean Change From Baseline to Week 12 in Pulse Rate|Pulse rate was measured at Baseline and Week 12 (end of study). Mean change from Baseline was calculated as the mean value at Week 12 minus the mean value at Baseline.|Baseline (Day 1) and Week 12|ITT Population. Only those participants with data available at both Baseline and Week 12 were analyzed.||Beats per minute (bpm)||Standard Deviation|Mean
778318|NCT00776919|Secondary|Mean Change From Baseline to Week 12 in Temperature|Temperature was measured at Baseline and Week 12 (end of study). Mean change from Baseline was calculated as the mean value at Week 12 minus the mean value at Baseline.|Baseline (Day 1) and Week 12|ITT Population. Only those participants with data available at both Baseline and Week 12 were analyzed.||Degrees centigrade||Standard Deviation|Mean
778319|NCT00776919|Secondary|Mean Change From Baseline to Week 12 in Systolic and Diastolic Blood Pressure|Systolic and diastolic blood pressure were measured at Baseline and Week 12 (end of study). Mean change from Baseline was calculated as the mean value at Week 12 minus the mean value at Baseline.|Baseline (Day 1) and Week 12|ITT Population. Only those participants with data available at both Baseline and Week 12 were analyzed.||Millimeters of mercury (mmHg)||Standard Deviation|Mean
778320|NCT00776919|Secondary|Number of Participants Who Had an ISGA Score of 0 or 1 at Week 12|During each study visit, investigators/assessors evaluated the acne severity of participants' faces using the ISGA scal: 0=clear skin with no lesions (L); 1=almost clear, rare non-inflammatory L; 2=mild, some non-inflammatory L with no more than a few inflammatory L, no nodular L; 3=moderate, many non-inflammatory L, may have some inflammatory L, but no more than 1 small nodular L; 4=severe, many non-inflammatory and inflammatory L, but no more than a few nodular L; 5=very severe, many non-inflammatory and inflammatory L, and more than a few nodular L.|Week 12|ITT Population. Participants with missing Week 12 evaluations were considered failures. Failures were defined as those participants with an ISGA score >=2.||participants|||Number
778321|NCT00776919|Secondary|Number of Participants Who Had a Subject Global Assessment (SGA) Score of 0 or 1 at Week 12|During each study visit, participants evaluated their facial acne (excluding the scalp) using the SGA scale: 0=free of acne, with only an occasional blackhead/whitehead; 1=several blackheads/whiteheads and small pimples, no tender deep-seated bumps/cysts; 2=several to many blackheads/whiteheads and small to medium-sized pimples, one deep-seated bump/cyst; 3=many blackheads/whiteheads, many medium- to large-sized pimples, few deep-seated bumps/cysts; 4=presence of blackheads/whiteheads, several to many medium- to large-sized pimples, deep-seated bumps/cysts dominate.|Week 12|ITT Population. Participants with missing Week 12 evaluations were considered failures. Failures were defined as those participants with an SGA score >=2.||participants|||Number
778331|NCT00776984|Secondary|Asthma Control as Assessed by Asthma Control Questionnaire (ACQ) at the End of the 24-week Treatment Period.|For the ACQ, the total score was calculated as the mean of the responses to 7 questions and was analysed as an absolute value. The score ranges from 0 (no impairment) to 6 (maximum impairment). MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|24 weeks|All patients from FAS.||Score on a scale||Standard Error|Mean
778322|NCT00776919|Secondary|Mean Percent Change From Baseline to Week 12 in Lesion Counts (Total, Inflammatory, and Non-inflammatory)|During each study visit, trained study personnel at every investigational center assessed the inflammatory (pustules, papules, nodules) and non-inflammatory (open and closed comedones) lesion counts for each participant. Each type of lesion was counted separately; the lesion counts were taken from the face (including forehead, nose, cheeks, and chin). Total lesion counts were calculated as the sum of the inflammatory and non-inflammatory lesion counts. Percent change from Baseline to Week 12 was calculated as the value at Week 12 minus the value at Baseline divided by the Baseline value * 100.|Baseline (Day 1) and Week 12|ITT Population. Participants who missed >=16 days of treatment or who reported they had lost their medication and never began treatment were excluded from the analysis. Missing values for all other participants were imputed using the LOCF method.||Percent change in lesion counts||Standard Deviation|Mean
778323|NCT00776919|Primary|Mean Change From Baseline to Week 12 in Total Lesion Counts|During each study visit, trained study personnel at every investigational center assessed the inflammatory (pustules, papules, nodules) and non-inflammatory (open and closed comedones) lesion counts for each participant. Each type of lesion was counted separately; the lesion counts were taken from the face (including forehead, nose, cheeks, and chin). Total lesion counts were calculated as the sum of the inflammatory and non-inflammatory lesion counts.|Baseline (Day 1) and Week 12|ITT Population. Participants who missed >=16 days of treatment or who reported they had lost their medication and never began treatment were excluded from the analysis. Missing values for all other participants were imputed using the LOCF method.||lesion counts||Standard Deviation|Mean
778324|NCT00776919|Primary|Mean Change From Baseline to Week 12 in Non-inflammatory Lesion Counts|During each study visit, trained study personnel at every investigational center assessed the non-inflammatory (open comedones [blackheads] and closed comedones [whiteheads]) lesion counts for each participant. Each type of lesion was counted separately, and counts were taken from the face (including forehead, nose, cheeks, and chin).|Baseline (Day 1) and Week 12|ITT Population. Participants who missed >=16 days of treatment or who reported they had lost their medication and never began treatment were excluded from the analysis. Missing values for all other participants were imputed using the LOCF method.||lesion counts||Standard Deviation|Mean
778325|NCT00776919|Primary|Mean Change From Baseline (BL) to Week 12 in Inflammatory Lesion Counts|During each study visit, trained study personnel at every investigational center assessed the inflammatory (pustules [small inflamed elevation of the skin that is filled with pus], papules [solid elevation of skin with no visible fluid], nodules [larger than papules with significant depth]) lesion counts for each participant. Each type of lesion was counted separately, and counts were taken from the face (including forehead, nose, cheeks, and chin). Missing values were imputed using the last observation carried forward (LOCF) method.|Baseline (Day 1) and Week 12|ITT Population. Participants who missed >=16 days of treatment or reported lost medication and never began treatment were excluded from the analysis. In the LOCF method, the last available observation, including BL, was used to estimate subsequent missing data points.||lesion counts||Standard Deviation|Mean
778326|NCT00776919|Primary|Number of Participants With Improvement of at Least 2 Grades in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12|During each study visit, investigators/assessors evaluated acne severity of the participants' faces using the ISGA scale: 0=clear skin with no lesions (L); 1=almost clear, rare non-inflammatory L; 2=mild, some non-inflammatory L with no more than a few inflammatory L, no nodular L; 3=moderate, many non-inflammatory L, may have some inflammatory L, but no more than 1 small nodular L; 4=severe, many non-inflammatory and inflammatory L, but no more than a few nodular L; 5=very severe, many non-inflammatory and inflammatory L, and more than a few nodular L.|Baseline (Day 1) and Week 12|Intent-to-Treat (ITT) Population: all participants who were randomized to and received at least 1 application of study product. Participants with missing Week 12 evaluations were considered failures. Failures are defined as those participants with a 1-grade improvement, no improvement, or a worsening.||participants|||Number
778327|NCT00776984|Post-Hoc|The Responder Rate as Assessed by the ACQ From the Two Twin Trials 205.416 (NCT00772538) and the Present 205.417 (NCT00776984)|"The responder rate as assessed by the Asthma Control Questionnaire (ACQ) determined at 24-weeks and 48-weeks (on combined data from the two twin trials 205.416 (NCT00772538) and 205.417 (NCT00776984)). A patient was considered to be a responder if he or she was reported with an improvement (decrease) in the ACQ total score of at least 0.5 points.
The ACQ total score was calculated as the mean of the responses to 7 questions and was analysed as an absolute value. The score ranges from 0 (no impairment) to 6 (maximum impairment).
This outcome definition is taken from the primary outcome definition for the twin trials 205.418 (NCT01172808) and 205.419 (NCT01172821) of the same development program."|24 weeks, 48 weeks|FAS of combined data from the two twin trials 205.416 (NCT00772538) and 205.417 (NCT00776984)||percentage of participants|||Number
778328|NCT00776984|Secondary|Mean Pro Re Nata (as Needed, PRN) Rescue Medication Use Response During the Last-7-days-before-week-24-visit .|Weekly means obtained during the last 7 days before week 24 visit were compared. The response is defined as the change of the weekly mean from the baseline weekly mean. The use of PRN salbutamol (albuterol rescue medication) is determined by the number of puffs of rescue therapy used per day. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and last 7 days before week 24 visit|All patients from FAS.||Puffs||Standard Error|Mean
778329|NCT00776984|Secondary|Asthma Symptom Free Days Response During the Last-7-days-before-week-24-visit .|Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). The response is defined as the change of the weekly mean from the baseline weekly mean. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and last 7 days before week 24 visit|All patients from FAS.||Days||Standard Error|Mean
778330|NCT00776984|Secondary|ACQ Score at the End of the 48-week Treatment Period.|For the ACQ, the total score was calculated as the mean of the responses to 7 questions and was analysed as an absolute value. The score ranges from 0 (no impairment) to 6 (maximum impairment). MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|48 weeks|All patients from FAS.||Scores on a scale||Standard Error|Mean
778468|NCT00778375|Primary|Median Overall Survival (OS)|Overall survival (OS): Time from date of treatment start until date of death due to any cause.|Evaluated from treatment date until date of death, followed for 5 years/60 months.|One participant of 119 treated was not evaluable for outcome.||Months||Full Range|Median
778332|NCT00776984|Secondary|AQLQ(S) Total Score at the End of the 48-week Treatment Period.|The AQLQ(S) total score was calculated as the mean of the responses to 32 questions for the domains Symptoms, Activity Limitations, Emotional Function and Environmental Stimuli and was analysed as an absolute value. The AQLQ(S) total score ranges from 1 (worst controlled) to 7 (best). MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|48 weeks|All patients from FAS.||Scores on a scale||Standard Error|Mean
778333|NCT00776984|Secondary|Quality of Life as Assessed by Standardised Asthma Quality of Life Questionnaire (AQLQ(S)) at the End of the 24-week Treatment Period.|The AQLQ(S) total score was calculated as the mean of the responses to 32 questions for the domains Symptoms, Activity Limitations, Emotional Function and Environmental Stimuli and was analysed as an absolute value. The AQLQ(S) total score ranges from 1 (worst controlled) to 7 (best). MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|24 weeks|All patients from FAS.||Scores on a scale||Standard Error|Mean
778334|NCT00776984|Secondary|Number of Patients With at Least One Hospitalisation for Asthma Exacerbation During the 48-week Treatment Period.||48 weeks|All patients from FAS.||Participants|||Number
778335|NCT00776984|Secondary|Number of Hospitalisations for Asthma Exacerbations Per Patient During the 48-week Treatment Period.||48 weeks|All patients from FAS.||Participants|||Number
778336|NCT00776984|Secondary|Time to First Hospitalisation for Asthma Exacerbation During the 48-week Treatment Period.|Asthma exacerbations (including severe, non-severe; symptomatic, asymptomatic) were pre-defined as an episode of progressive increase in 1 or more asthma symptoms (e.g. shortness of breath, cough, wheezing, chest tightness or some combination of these symptoms). Additionally, decrease of patients best PEF a.m. of 30 percent or more from the patients mean PEF a.m. for at least 2 consecutive days was considered to be an objective marker of asthma exacerbation.|48 weeks|All patients from FAS. As < 50 percent (10 of 232 patients in the placebo group and 8 of 216 patients in the Tio R5 group) of patients had severe exacerbation, the median time was not calculable.|||||
778337|NCT00776984|Secondary|Number of Patients With at Least One Severe Asthma Exacerbation During the 48-week Treatment Period.|Severe asthma exacerbations were pre-defined as all asthma exacerbations that required treatment with systemic (including oral) corticosteroids for at least 3 days or (in case of ongoing and pre-existing systemic corticosteroid therapy) that required at least a doubling of the previous daily dose of systemic corticosteroids for at least 3 days.|48 weeks|All patients from FAS.||Participants|||Number
778338|NCT00776984|Secondary|Number of Patients With at Least One Asthma Exacerbation During the 48-week Treatment Period.|Asthma exacerbations (including severe, non-severe; symptomatic, asymptomatic) were pre-defined as an episode of progressive increase in 1 or more asthma symptoms (e.g. shortness of breath, cough, wheezing, chest tightness or some combination of these symptoms). Additionally, decrease of patients best PEF a.m. of 30 percent or more from the patients mean PEF a.m. for at least 2 consecutive days was considered to be an objective marker of asthma exacerbation.|48 weeks|All patients from FAS.||Participants|||Number
778339|NCT00776984|Secondary|Number of Severe Asthma Exacerbations Per Patient During the 48-week Treatment Period.|Severe asthma exacerbations were pre-defined as all asthma exacerbations that required treatment with systemic (including oral) corticosteroids for at least 3 days or (in case of ongoing and pre-existing systemic corticosteroid therapy) that required at least a doubling of the previous daily dose of systemic corticosteroids for at least 3 days.|48 weeks|All patients from FAS.||Participants|||Number
778340|NCT00776984|Secondary|Number of Asthma Exacerbations Per Patient During the 48-week Treatment Period.|Asthma exacerbations (including severe, non-severe; symptomatic, asymptomatic) were pre-defined as an episode of progressive increase in 1 or more asthma symptoms (e.g. shortness of breath, cough, wheezing, chest tightness or some combination of these symptoms). Additionally, decrease of patients best PEF a.m. of 30 percent or more from the patients mean PEF a.m. for at least 2 consecutive days was considered to be an objective marker of asthma exacerbation.|48 weeks|All patients from FAS.||Participants|||Number
778341|NCT00776984|Secondary|Time to First Severe Asthma Exacerbation During the 48-week Treatment.|Severe asthma exacerbations were pre-defined as all asthma exacerbations that required treatment with systemic (including oral) corticosteroids for at least 3 days or (in case of ongoing and pre-existing systemic corticosteroid therapy) that required at least a doubling of the previous daily dose of systemic corticosteroids for at least 3 days.|48 weeks|All patients from FAS. As < 50 percent (81 of 232 patients in the placebo group and 69 of 216 patients in the Tio R5 group) of patients had severe exacerbation, the median time was not calculable.|||||
778342|NCT00776984|Secondary|Mean PEF Variability Response (Absolute Difference Between Morning and Evening PEF Value Divided by Their Mean) of Last-7-days-before-week 24-visit.|Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). The PEF variability is the absolute difference between morning and evening PEF value divided by their mean, expressed as a percent. Response was defined as change from baseline. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and last 7 days before week 24 visit|All patients from FAS.||Percent||Standard Error|Mean
778343|NCT00776984|Secondary|Mean Pre-dose FEV1-p.m.Response (Diary Data) of Last-7-days-before-week 24-visit.|Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). Response was defined as change from baseline. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and last 7 days before week 24 visit|All patients from FAS.||Liter||Standard Error|Mean
778344|NCT00776984|Secondary|Mean Pre-dose FEV1 a.m. Response (Diary Data) of Last-7-days-before-week 24-visit.|Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). Response was defined as change from baseline. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and last 7 days before week 24 visit|All patients from FAS.||Liter||Standard Error|Mean
778345|NCT00776984|Secondary|Mean Pre-dose Evening Peak Expiratory Flow (PEFp.m.) Response (Diary Data) of Last-7-days-before-week 24-visit.|Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). Response was defined as change from baseline. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and last 7 days before week 24 visit|All patients from FAS.||L/min||Standard Error|Mean
778346|NCT00776984|Secondary|Mean Pre-dose Morning Peak Expiratory Flow (PEFa.m.) Response (Diary Data) of Last-7-days-before-week-24-visit .|Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). Response was defined as change from baseline. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and last 7 days before week 24 visit|All patients from FAS.||L/min||Standard Error|Mean
778347|NCT00776984|Secondary|FVC AUC0-3h Response at the End of the 48-week Treatment Period.|The AUC0-3h was calculated as area under the curve from zero to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. The trough value was assigned to zero time. Response was defined as change from baseline in FVC AUC0-3h after a treatment period of 48 weeks. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit baseline*visit.|Baseline and 48 weeks|All patients from FAS.||Liter||Standard Error|Mean
778348|NCT00776984|Secondary|Trough FVC Response at the End of the 48-week Treatment Period.|The trough FVC is defined as the pre-dose FVC measured 10 minutes before the last administration of randomised treatment. Trough FVC response was defined as the difference between the trough FVC measured after a treatment period of 48 weeks and the FVC baseline measurement. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 48 weeks|All patients from FAS.||Liter||Standard Error|Mean
778349|NCT00776984|Secondary|Peak FVC 0-3h Response at the End of the 48-week Treatment Period.|Peak FVC 0-3h response was defined as the difference between the maximum FVC measured within the first 3 hours post dosing after a treatment period of 48 weeks and the FVC baseline measurement (10 minutes before the first dose of trial medication). MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 48 weeks|All patients from FAS.||Liter||Standard Error|Mean
778350|NCT00776984|Secondary|AUC0-3h FEV1 Response at the End of the 48-week Treatment Period.|The AUC0-3h was calculated as area under the curve from zero to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. The trough value was assigned to zero time. Response was defined as change from baseline in FEV1 AUC0-3h after a treatment period of 48 weeks. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit baseline*visit.|Baseline and 48 weeks|All patients from FAS.||Liter||Standard Error|Mean
778351|NCT00776984|Secondary|Trough FEV1 Response at the End of the 48-week Treatment Period.|The trough FEV1 is defined as the pre-dose FEV1 measured 10 minutes before the last administration of randomised treatment. Trough FEV1 response was defined as the difference between the trough FEV1 measured after a treatment period of 48 weeks and the FEV1 baseline measurement. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 48 weeks|All patients from FAS.||Liter||Standard Error|Mean
778352|NCT00776984|Secondary|Peak FEV1 0-3h Response at the End of the 48-week Treatment Period.|Peak FEV1 0-3h response was defined as the difference between the maximum FEV1 measured within the first 3 hours post dosing after a treatment period of 48 weeks and the FEV1 baseline measurement (10 minutes before the first dose of trial medication). Mixed Model Repeated Measure (MMRM) results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 48 weeks|All patients from FAS.||Liter||Standard Error|Mean
778353|NCT00776984|Secondary|FVC (AUC0-3h) Response at the End of the 24-week Treatment Period.|The AUC0-3h was calculated as area under the curve from zero to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. The trough value was assigned to zero time. Response was defined as change from baseline in FVC AUC0-3h after a treatment period of 24 weeks. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit baseline*visit.|Baseline and 24 weeks|All patients from FAS.||Liter||Standard Error|Mean
778354|NCT00776984|Secondary|FEV1 Area Under the Curve (AUC0-3h) Response at the End of the 24-week Treatment Period.|The AUC0-3h was calculated as area under the curve from zero to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. The trough value was assigned to zero time. Response was defined as change from baseline in FEV1 AUC0-3h after a treatment period of 24 weeks. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit baseline*visit.|Baseline and 24 weeks|All patients from FAS.||Liter||Standard Error|Mean
778355|NCT00776984|Secondary|Trough FVC Response at the End of the 24-week Treatment Period.|The trough FVC is defined as the pre-dose FVC measured 10 minutes before the last administration of randomised treatment. Trough FVC response was defined as the difference between the trough FVC measured after a treatment period of 24 weeks and the FVC baseline measurement. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 24 weeks|All patients from FAS.||Liter||Standard Error|Mean
778356|NCT00776984|Secondary|Peak (Within 3 Hours Post-dosing) Forced Vital Capacity (FVC) Response at the End of the 24-week Treatment Period.|Peak FVC 0-3h response was defined as the difference between the maximum FVC measured within the first 3 hours post dosing after a treatment period of 24 weeks and the FVC baseline measurement (10 minutes before the first dose of trial medication). Mixed Model Repeated Measure (MMRM) results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 24 weeks|All patients from FAS.||Liter||Standard Error|Mean
778357|NCT00776984|Primary|Time to First Severe Asthma Exacerbation During the 48-week Treatment of the Pooled Data From the Two Twin Trials 205.416 (NCT00772538) and the Present 205.417 (NCT00776984).|Severe asthma exacerbations were pre-defined as all asthma exacerbations that required treatment with systemic (including oral) corticosteroids for at least 3 days or (in case of ongoing and pre-existing systemic corticosteroid therapy) that required at least a doubling of the previous daily dose of systemic corticosteroids for at least 3 days.|48 weeks|All patients from FAS of the pooled twin studies 205.416 and 205.417. As <50percent (149 of 454 patients in the placebo group and 122 of 453 patients in the Tio R5 group) of patients had severe exacerbation, the median time was not calculable.||Days||Inter-Quartile Range|Median
778358|NCT00776984|Primary|Trough FEV1 Response Determined After a Treatment Period of 24 Weeks.|The trough FEV1 is defined as the pre-dose FEV1 measured 10 minutes before the last administration of randomised treatment. Trough FEV1 response was defined as the difference between the trough FEV1 measured after a treatment period of 24 weeks and the FEV1 baseline measurement. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 24 weeks|All patients from FAS.||Liter||Standard Error|Mean
778359|NCT00776984|Primary|Peak Forced Expiratory Volume in 1 Second (FEV1) Response Within 3 Hours Post Dosing (0-3h) After a Treatment Period of 24 Weeks.|Peak FEV1 0-3h response was defined as the difference between the maximum FEV1 measured within the first 3 hours post dosing after a treatment period of 24 weeks and the FEV1 baseline measurement (10 minutes before the first dose of trial medication). Mixed Model Repeated Measure (MMRM) results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 24 weeks|All patients from Full Analysis Set (FAS) FAS is defined as all patients in the treated set who have baseline data and at least one on-treatment efficacy value.||Liter||Standard Error|Mean
778360|NCT00776997|Secondary|Average Daily Proton-pump Inhibitor (PPI) Dosage Reduced by at Least 50% Compared to Baseline||12 months|||participants|||Number
778361|NCT00776997|Secondary|At Least a 50% Reduction in Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) Total Score Compared to Baseline||12 months|||participants|||Number
778362|NCT00776997|Primary|Normalization of Esophageal Acid Exposure Time or Reduced Total Acid Exposure Time of at Least 50% Compared to the Subject's Baseline Measurement by Esophageal pH Testing.|The analysis cohort for the primary efficacy analysis was the treated population which includes all implanted subjects and was determined through esophageal pH testing.|12 Months|||participants|||Number
778363|NCT00776997|Primary|Rate of Occurrence for Device and Procedure Related Serious Adverse Events (SAEs).|"SAE was defined as any untoward medical occurrence, whether related to the study device or procedure or not, that meets one or more of the following criteria:
Results in death
Is life-threatening
Requires subject hospitalization > 24 hours
Requires prolongation of an existing hospitalization
Results in persistent or significant disability/incapacity
Results in fetal distress, fetal death, or a congenital anomaly or birth defect
Requires intervention to prevent permanent impairment or damage.
Outcome measure reports number of subjects with reported events."|through 24 months|||participants|||Number
778364|NCT00777023|Primary|Change From Baseline in Average Daily Severity Score of Moderate or Severe Hot Flashes After 12 Weeks of Treatment|"Mean change from baseline in average daily severity score of moderate or severe hot flashes at stable dose week (SDW) 12 of treatment relative to placebo; last observation carried forward (LOCF) analysis.
Severity of hot flashes is scored on a scale of 1 to 3 where 1=mild, 2=moderate, 3=severe."|At baseline and 12 weeks of treatment|Intent to treat population||Units on a scale||95% Confidence Interval|Least Squares Mean
778365|NCT00777023|Primary|Change From Baseline in Average Daily Severity Score of Moderate or Severe Hot Flashes After 4 Weeks of Treatment|"Mean change from baseline in average daily severity score of moderate or severe hot flashes at stable dose week (SDW) 4 of treatment relative to placebo; last observation carried forward (LOCF) analysis.
Severity of hot flashes is scored on a scale of 1 to 3 where 1=mild, 2=moderate, 3=severe."|At baseline and 4 weeks of treatment|Intent to treat population||Units on a scale||95% Confidence Interval|Least Squares Mean
778366|NCT00777023|Primary|Change From Baseline in Average Daily Frequency of Moderate or Severe Hot Flashes After 12 Weeks of Treatment|Mean change from baseline in average daily number of moderate or severe hot flashes at stable dose week (SDW) 12 of treatment relative to placebo; last observation carried forward (LOCF) analysis|At baseline and 12 weeks of treatment|Intent to treat population||Hot flashes||95% Confidence Interval|Least Squares Mean
778367|NCT00777023|Primary|Change From Baseline in Average Daily Frequency of Moderate or Severe Hot Flashes After 4 Weeks of Treatment|Mean change from baseline in average daily number of moderate or severe hot flashes at stable dose week (SDW) 4 of treatment relative to placebo; last observation carried forward (LOCF) analysis|At baseline and 4 weeks of treatment|Intention to treat population||Hot flashes||95% Confidence Interval|Least Squares Mean
778368|NCT00777049|Primary|Objective Response Rate (as Determined by Investigator): the Percentage of Patients Assigned to a Treatment Arm With a Confirmed Best Response of CR or PR.|The assessment of overall response (OR) is based on the response of target lesion, of non-target lesion, and on presence of new lesions (RECIST criteria version 1.0 using imaging techniques; as per investigator assessment).|6 years and 2 months|||participants|||Number
778369|NCT00777062|Primary|Time Line Follow Back -Reported Days of Abstinence From Drinking|Percentage of participants who were abstinent from drinking|8 week medication phase|||Percentage of Participants|||Number
778370|NCT00777062|Primary|Urine Assay for Benzoylecgonine (BE), the Primary Metabolite of Cocaine.|Percentage of subjects with no cocaine use for at least 3 weeks|8 week medication phase|||Percentage of Participants|||Number
778371|NCT00777153|Secondary|Steroid Free Days|Number of days known not to have used any steroids prior to progression|Baseline to the date of first documented progression or date of death or study discontinuation, whichever came first, assessed up to 2014-April-25|||Days||Standard Deviation|Mean
778372|NCT00777153|Secondary|Daily Steroid Dose|The mean steroid dosage prior to treatment will be considered as the patient’s baseline. The percent change in average daily steroid dosage from baseline is calculated by following formula: PC = (md – bm)/bm*100; where PC is the percent change in average daily steroid dosage from baseline; md the mean daily steroid dosage recorded from the first day of therapy to progression; and bm the baseline mean.|Baseline to the date of first documented progression or date of death or study discontinuation, whichever came first, assed up to 2014-April-25|||percentage of change|||Number
778373|NCT00777153|Secondary|Alive and Progression Free Rate at 6 Months (APF6)|Proportion of patients alive and progression free at 6 months (based on central review) as estimated from Kaplan-Meier techniques. Values are percentages.|6 Months|||% of patients alive and progression free|||Number
778374|NCT00777153|Secondary|Response Rate|"An individual visit response of PR was defined as a greater than or equal to 50% reduction in the sum of the products of the largest perpendicular diameters of contrast enhancement for all lesions compared to baseline as long as the steroid dose has not been increased within the previous 10 days and no new lesions are present.
An individual visit response of CR was defined as the complete disappearance of all tumor on MRI scan."|Baseline at 6 weeks and then every 6 weeks to discontinuation|Patients are only included in the analysis if they have measurable disease at baseline based on central.||Participants|||Number
778375|NCT00777153|Secondary|Overall Survival (OS)|Number of months from randomisation to the date of death from any cause|Baseline through to date of death up to 25th April 2010|||Months||Inter-Quartile Range|Median
782483|NCT00813761|Primary|Average Daily Wear Time|Average hours per day that contact lens were worn.|24 weeks|Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.||Hours||Standard Error|Least Squares Mean
778376|NCT00777153|Primary|Progression Free Survival (PFS)|"For patients with measurable disease at entry (at least one lesion that has a shortest diameter
≥10 mm at baseline on 2 axial slices), PFS will be defined as the earliest time that:
The sum of the products of the largest perpendicular diameters of contrast enhancement for all lesions has increased by a greater than or equal to 25% in comparison to the nadir scan as long as the shortest diameter is ≥15 mm. If the dose of steroids has been reduced within the 10 days prior to the scan being conducted, progression will be based on a follow-up scan performed after the dose of steroids has been stabilized for 10 days.
The patient has died from any cause.
A new lesion is detected that is outside the original tumor volume and has a shortest diameter ≥10 mm."|Baseline at 6 weeks and then every 6 weeks to discontinuation|||Days||Inter-Quartile Range|Median
778377|NCT00777179|Secondary|Objective Response Rate (ORR)|"Number of patients showing Complete Response (CR) or Partial Response (PR) based on RECIST for the best response.
Number of patients showing Complete Response (CR, disappearance of all target lesions) or Partial Response (PR, at least a 30% decrease in the sum of longest diameter of target lesions taking as reference the baseline sum longest diameter) based on RECIST Criteria Version 1.0 (assessed by CT and/or MRI) for the best response."|Performed at baseline, every 4 weeks until Week 12 following randomization and then every 8 weeks until objective disease progression.|||Participants|||Number
778378|NCT00777179|Secondary|Disease of Response (DOR)|"Number of patients showing Complete Response (CR), Partial Response (PR) or Stable Disease (SD) based on RECIST for the best response.
Number of patients showing Complete Response (CR, disappearance of all target lesions), Partial Response (PR, at least a 30% decrease in the sum of longest diameter of target lesions taking as reference the baseline sum longest diameter) or Stable Disease (SD, Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum longest diameter since the treatment started) based on RECIST Criteria Version 1.0 (assessed by CT and/or MRI) for the best response"|Performed at baseline, every 4 weeks until Week 12 following randomization and then every 8 weeks until objective disease progression.|||Participants|||Number
778379|NCT00777179|Secondary|Overall Survival (OS)|Overall survival (OS) defined as the median time from randomization to death from any cause.|Every 12 weeks unless the patient withdraws consent|||months||95% Confidence Interval|Median
778380|NCT00777179|Secondary|Progression-free Survival (PFS)|Progression-free survival (PFS) defined as the median time from randomization to death from any cause or first observed disease progression.|Performed at baseline, every 4 weeks until Week 12 following randomization and then every 8 weeks until objective disease progression.|||months||95% Confidence Interval|Median
778381|NCT00777179|Primary|Progression-free Survival (PFS) Rate at 3 Months|Progression-free survival (PFS) rate at 3 months is defined as the number of patients without evidence of progression or death after 3 months from randomisation among the PFS-evaluable patients.|12 weeks|The reported number of participants analyzed (Vandetanib: 63, Placebo: 38) are for PFS evaluable patient set.||Participants|||Number
778382|NCT00777205|Primary|Recovery Orientation|The 30-item Mental Health Recovery Measure (MHRM) was used to assess recovery orientation. The MHRM has been fielded among diverse populations and has a high level of internal consistency (Cronbach’s α =.93) and shows change following engagement in recovery oriented treatments. The MHRM is scored using a 5 point Likert Scale (0 to 4) for each item, yielding a theoretical range from 0 – 120 for Total Score. Higher scores correspond to a higher self-reported level of mental health recovery.|Change over study period|Fifty-six of the patients randomized to the telephone-based peer support intervention were excluded from main study analyses because of an unforeseen disruption in their 6-month intervention that was unrelated to patient characteristics.||units on a scale||Standard Deviation|Mean
778383|NCT00777205|Primary|Depression Symptoms|The 21-item Beck Depression Inventory-2nd Edition (BDI-II) was used to assess depressive symptoms. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.|Change over study period|Fifty-six of the patients randomized to the telephone-based peer support intervention were excluded from main study analyses because of an unforeseen disruption in their 6-month intervention that was unrelated to patient characteristics.||units on a scale||Standard Deviation|Mean
778384|NCT00777205|Primary|Quality of Life|The 14-item Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF), which has good reliability and has been used in multiple depression studies, was used to assess quality of life. Responses are scored on a 5-point scale (‘not at all or never’ to ‘frequently or all the time’), where higher scores indicate better enjoyment and satisfaction with life (possible range 14–70).|Change over study period|Fifty-six of the patients randomized to the telephone-based peer support intervention were excluded from main study analyses because of an unforeseen disruption in their 6-month intervention that was unrelated to patient characteristics.||units on a scale||Standard Deviation|Mean
778385|NCT00777205|Primary|Change in Functional Status-Physical Health (PCS) Over 12 Month Period|The Veterans Rand 36 Item Health Survey (VR-36) mental health component score (MCS) and physical health component score (PCS) were used as measures of functional status. The MCS and PCS have a mean of 50 and standard deviation of 10, with higher scores indicating better health.|Change over study period|Fifty-six of the patients randomized to the telephone-based peer support intervention were excluded from main study analyses because of an unforeseen disruption in their 6-month intervention that was unrelated to patient characteristics.||units on a scale||Standard Deviation|Mean
778386|NCT00777205|Primary|Change in Functional Status-Mental Health (MCS) Over 12 Month Period|The Veterans Rand 36 Item Health Survey (VR-36) mental health component score (MCS) and physical health component score (PCS) were used as measures of functional status. The MCS and PCS have a mean of 50 and standard deviation of 10, with higher scores indicating better health.|Change over study period|Fifty-six of the patients randomized to the telephone-based peer support intervention were excluded from main study analyses because of an unforeseen disruption in their 6-month intervention that was unrelated to patient characteristics.||units on a scale||Standard Deviation|Mean
778387|NCT00777257|Primary|Geometric Mean Concentrations (GMCs) of Pertussis Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine.||Day 0 and Day 28 Post-vaccination|Geometric mean concentration for each vaccine antigen was evaluated in the per-protocol population.||EU/mL||95% Confidence Interval|Geometric Mean
779175|NCT00778817|Secondary|Number of Patients Exhibiting Decrease in Tumor Size at 6 Weeks|Total number of patients whose tumor size at 6 weeks was smaller than their tumor size recorded at baseline (by any amount).|6 weeks|The analysis population excludes two patients who withdrew from the study before the 6 week assessment.||participants|||Number
778388|NCT00777257|Secondary|Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively.|Solicited injection sites reactions: Erythema, swelling, and pain. Solicited systemic reactions: Fever (temperature), headache, malaise, and myalgia.|0 to 7 days post-vaccination|Safety analysis was on all enrolled and vaccinated participants intend-to-treat population||Percentage of participants|||Number
778389|NCT00777257|Primary|Geometric Mean Concentrations (GMCs) of Diphtheria and Tetanus Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine.||Day 0 and Day 28 post-vaccination|Geometric mean concentration for each vaccine antigen was evaluated in the per-protocol population.||IU/mL||95% Confidence Interval|Geometric Mean
778390|NCT00777257|Primary|Percentage of Participants With at Least a 4-fold Rise in Meningococcal Antibody Titer From Baseline (Day 0) to Day 28 Post-vaccination With Menactra® Vaccine.||Day 0 to Day 28 post-vaccination|Serum bactericidal activity using baby rabbit complement (SBA-BR) titers for each meningococcal serogroup was evaluated in the per-protocol population||Percentage of participants|||Number
778391|NCT00777335|Secondary|Corrected QT Interval Fridericia's Formula (QTcF)|Prolonged QTcF: QTcF >450 msec and increase of baseline on greater than or equal to 60 msec.|Panobinostat intra-venous (i.v.): All cycles pre-dose measurements. For cycles 1 and 2, post-dose measurements as well. / Panobinostat oral: Pre-dose and post-dose measurements for all cycles. Note: each cycle = 3 weeks|||participants|||Number
778392|NCT00777335|Primary|Overall Response (OR) Rate (as Determined by the Investigator): the Number of Patients Assigned to a Treatment Arm With a Confirmed Best Response of Complete Response(CR) or Partial Response (PR).|"The assessment of OR is based on the response of target lesion, of non-target lesion and on presence of new lesions (RECIST Criteria (V1.0)-assessed by CT scan spiral and bone scan)
CR:Disappearance of all target lesions
PR:>=30% increase in the sum of the longest diameter (SLD),taking as reference the nadir SLD
Progressive Disease (PD):>=20% increase in the SLD, taking as reference the nadir SLD, or the appearance of one or more new lesions
Stable Disease(SD):Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the nadir SLD"|At screening, every 2 cycles (i.e. 6 weeks) during the first 6 cycles, every 3 cycles (i.e. 9 weeks) during the subsequent cycles and at the End of Treatment (EOT) visit. After the EOT, the tumor assessments should be performed every 9 weeks.|||participants|||Number
778393|NCT00777556|Secondary|Participants Summarized by Repeat Use of Emergency Contraception (EC)|As each participant dispensed Plan B® 1.5 was only given one tablet, repeat use of emergency contraception (EC) indicates use of an EC product other than the study product. Categories reflect the number of repeat uses.|up to week 8|Participants dispensed the product||participants|||Number
778394|NCT00777556|Secondary|Participants With Treatment-Emergent Adverse Events (TEAE)|Treatment-emergent adverse events included adverse events reported during the protocol-specified following up contacts at weeks 1, 4 and 8 or at any other participant contact for participants who took study drug.|Day 1 to week 8|Safety population of participants who took study drug||participants|||Number
778395|NCT00777556|Primary|Percentage of Participants Who Correctly Used DR-104 When Dispensed Under Simulated OTC Conditions|The percentage of participants who having appropriately self-selected and been dispensed Plan B® 1.5, correctly used it according to product labeling. Correct use was considered to have occurred if participants reported at the Week 1 follow-up contact that she took Plan B® 1.5 within 72 hours following unprotected sexual intercourse. Following the standard norms for a therapy to over-the-counter (Rx-to-OTC) switch process, this outcome is an evaluation of potential consumers' ability to self-treat with the product according to the product instructions.|Week 1|Eligible participants who appropriately self-selected and used the product.||percentage of treated participants||95% Confidence Interval|Number
778396|NCT00777556|Primary|Percentage of Participants Who Appropriately Self-selected DR-104 (Plan B® 1.5) When Dispensed Under Simulated Over-the-counter (OTC) Conditions|The percentage of participants who appropriately self-selected Plan B® 1.5 at the Screening/Enrollment Visit after reading the product label. Following the standard norms for a therapy to over-the-counter (Rx-to-OTC) switch process, this outcome is an evaluation of potential consumers' ability to self-diagnose the condition and that treatment with the product is appropriate for them.|Day 1|Enrolled participants||percentage of participants||95% Confidence Interval|Number
778397|NCT00777608|Secondary|Evaluate the Efficacy of Donepezil by Determining the Change in Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Score at Week 4, Week 8 and Week 12|"The ADAS-Cog is a psychometric instrument that evaluates memory, attention,
reasoning, language, orientation and praxis using an 11-point AD Assessment Scale. It has a minimum score of 0 and a maximum severity score of 70, and a higher score indicates more impairment. A reduction in scores compared to baseline indicates an improvement in cognitive functions. Reported here is the change in the ADAS-Cog score at Weeks 4, 8 and 12 compared to baseline."|Baseline and 4 weeks, 8 weeks and 12 weeks.|The analysis for the primary and secondary CogState endpoints was done on a per protocol basis (only participants who were compliant and successfully tolerated the forced titration after 2 weeks of treatment were included in the analysis).||Score on a scale||Standard Error|Least Squares Mean
778398|NCT00777608|Secondary|Evaluate the Efficacy of Donepezil by Determining the Change in Mean CogState Composite Score at Week 2, Week 8 and Week 12|CogState is a simple, brief computerized neuropsychological battery to evaluate cognitive impairments characterizing mild-to-moderate Alzheimer’s Disease (AD). The composite CogState assesses attention and memory functions - including Verbal episodic memory, Visual Episodic Memory, Psychomotor function, Visual attention and working memory. CogState scores are measured on a linear scale (no maximum score) and a reduction in scores compared to baseline indicates an improvement in cognitive functions. Reported here is the change from baseline in the CogState Composite Score at Weeks 4, 8 and 12.|Baseline and 2 weeks, 8 weeks and 12 weeks|The analysis for the primary and secondary CogState endpoints was done on a per protocol basis (only participants who were compliant and successfully tolerated the forced titration after 2 weeks of treatment were included in the analysis).||Score on a scale||Standard Error|Least Squares Mean
778399|NCT00777608|Primary|Change in Mean Computer-based Cognitive Assessment (CogState) Composite Score at Week 4|CogState is a simple, brief computerized neuropsychological battery to evaluate cognitive impairments characterizing mild-to-moderate Alzheimer’s Disease (AD). The composite CogState assesses attention and memory functions - including Verbal episodic memory, Visual Episodic Memory, Psychomotor function, Visual attention and working memory. CogState scores are measured on a linear scale (with no maximum score) and a reduction in scores compared to baseline indicates an improvement in cognitive functions. Reported here is the change in the CogState Composite Score at Week 4 compared to baseline.|Baseline and 4 weeks|The analysis for the primary and secondary CogState endpoints was done on a per protocol basis (only participants who were compliant and successfully tolerated the forced titration after 2 weeks of treatment were included in the analysis).||Score on a scale||Standard Error|Least Squares Mean
778400|NCT00777634|Primary|Incidence of Diagnosis of Three or More Metabolic Syndrome Components|The number of participants to acquire a new diagnosis of three or more components of metabolic syndrome. Metabolic syndrome can include abdominal obesity, high blood pressure, high cholesterol, etc.|Baseline to 5 years|||participants|||Number
778401|NCT00777634|Primary|Incidence of Diagnosis of Two or More Metabolic Syndrome Components|The number of participants to acquire a new diagnosis of two or more components of metabolic syndrome. Metabolic syndrome can include abdominal obesity, high blood pressure, high cholesterol, etc.|Baseline to 5 years|||participants|||Number
778402|NCT00777634|Primary|Incidence of Diagnosis of Any Metabolic Syndrome Component|The number of participants to acquire a new diagnosis of one component of metabolic syndrome. Metabolic syndrome can include abdominal obesity, high blood pressure, high cholesterol, etc.|Baseline to 5 years|||participants|||Number
778403|NCT00777634|Primary|Incidence of Diagnosis of Type 2 Diabetes|The number of participants to acquire a new diagnosis of Type 2 Diabetes over the course of the baseline to five-year followup.|Baseline to 5 years|||participants|||Number
778404|NCT00777634|Primary|Incidence of Diagnosis of Hypertension|The number of participants to acquire a new diagnosis of high blood pressure(hypertension) over the course of the baseline to five-year followup.|Baseline to 5 years|||participants|||Number
778405|NCT00777634|Primary|Incidence of Diagnosis of Dyslipidemia|The number of participants to acquire a new diagnosis of high cholesterol (dyslipidemia) over the course of the baseline to five-year followup.|Baseline to 5 years|||participants|||Number
778406|NCT00777764|Primary|Number of Participants Who Experienced a Positive Skin Reaction (Intradermal Test in Patients With Allergic Asthma)|For intradermal testing, positive control (histamine 0.1 mg/mL) and negative control (saline) were used. Positive skin reaction was defined as a ≥ 3-mm wheal and/or > 10-mm erythema from negative control. The intradermal test started with the lowest concentration. If a positive skin reaction was observed, escalation to the next dilution was stopped.|on the day of skin test|Safety population. For 1:100,000 dilutions: n=30; for 1:10,000 dilutions: n=29. The skin tests started with the lowest concentration. If a positive skin reaction was observed, escalation to the next dilution was stopped (i.e., reason for different Ns per dilution.)||participants|||Number
778407|NCT00777764|Primary|Number of Participants Who Experienced a Positive Skin Reaction (Intradermal Test in Healthy Volunteers)|For intradermal testing, positive control (histamine 0.1 mg/mL) and negative control (saline) were used. Positive skin reaction was defined as a ≥ 3-mm wheal and/or > 10-mm erythema from negative control. The intradermal test started with the lowest concentration. If a positive skin reaction was observed, escalation to the next dilution was stopped.|on the day of skin test|Safety population. For 1:1000 dilutions: n=27; for 1:100 dilutions: n=21; for 1:10 dilutions: n=13. The skin tests started with the lowest concentration. If a positive skin reaction was observed, escalation to the next dilution was stopped (i.e., reason for different Ns per dilution.)||participants|||Number
778408|NCT00777764|Primary|Number of Participants Who Experienced a Positive Skin Reaction (Skin Prick Test)|For skin prick, positive control (histamine 6 mg/mL) and negative control (saline) were used. Positive skin reaction was defined as a ≥ 3-mm wheal and/or > 10-mm erythema from negative control. The skin prick test started with the lowest concentration. If a positive skin reaction was observed, escalation to the next dilution was stopped.|on the day of skin test|Safety population, defined as subjects who received at least one concentration of omalizumab or omalizumab excipient. For healthy volunteer cohort, undiluted: n=29. The skin tests started with the lowest concentration. If a positive skin reaction was observed, escalation to the next dilution was stopped (i.e., reason for different Ns per dilution.)||participants|||Number
778409|NCT00777764|Primary|Number of Participants by of Adverse Events Following a Skin Test Procedure|"Skin test procedures were skin prick test or intradermal test. The test started with the lowest concentration. If a positive skin reaction was observed, escalation to the next dilution was stopped. Subjects were observed for 20 minutes following each test; subjects were observed for 1 hour after the last intradermal test. Those with a positive response were observed for an additional 6 hours.
Severity refers to the intensity of an AE (mild, moderate or severe). Mild is itching or hives, for example. A severe event requires emergency medical treatment and can result in death."|Up to 7 days following skin testing|Safety population, defined as subjects who received at least one concentration of omalizumab or omalizumab excipient.||participants|||Number
778410|NCT00777790|Primary|Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups.|Geometric mean titers and their 95% confidence interval of serum bactericidal activity for the 4 vaccine serogroups before vaccination, at 8 days post- and 28 days post-booster dose of Menactra vaccine or a primary dose of Menactra vaccine in the meningococcal vaccine-naïve Control group.|Day 0 and 8 and 28 days post-vaccination|GMT results were on the per-protocol population for immunogenicity.||Titer||95% Confidence Interval|Geometric Mean
778411|NCT00777803|Secondary|Responder by Patient's Global Assessment at Week 12|The Outcome Measure Data Table describes the number of responders. A response is defined as a score of at least +2 (moderate improvement) on a 9-point scale (range from +4 complete improvement to -4 very marked worsening) 12 weeks after treatment rated by the patient.|12 weeks after injection|Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing scores were not imputed.||participants|||Number
779017|NCT00786565|Primary|Photopic Contrast Sensitivity|The mean photopic (day light) contrast sensitivity for each spatial frequency (cycle per degree-CPD) (1.5, 3.0, 6.0, 12.0 and 18 cpd)|3 months|All patients who had cataract surgery and who have at least one baseline value and one post-baseline value for efficacy criteria.||Log 10||Standard Deviation|Mean
778412|NCT00777803|Secondary|Responder by Patient's Global Assessment at Week 4|The Outcome Measure Data Table describes the number of responders. A response is defined as a score of at least +2 (moderate improvement) on a 9-point scale (range from +4 complete improvement to -4 very marked worsening) 4 weeks after treatment rated by the patient.|4 weeks after injection|Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing scores were not imputed.||participants|||Number
778413|NCT00777803|Secondary|Response by Patient's Assessment at Rest at Week 12|The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 12 weeks thereafter rated by the patient. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.|12 weeks after injection|Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.||participants|||Number
778414|NCT00777803|Secondary|Responder by Patient's Assessment at Rest at Week 4|The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 4 weeks thereafter at rest rated by the patient. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.|4 weeks after injection|Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.||participants|||Number
778415|NCT00777803|Secondary|Responder by Patient’s Assessment at Maximum Frown at Week 12|The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 12 weeks thereafter at maximum frown rated by the patient. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.|12 weeks after injection|Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.||participants|||Number
778416|NCT00777803|Secondary|Responder by Patient’s Assessment at Maximum Frown at Week 4|The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 4 weeks thereafter at maximum frown rated by the patient. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.|4 weeks after injection|Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.||participants|||Number
778417|NCT00777803|Secondary|Responder by Investigator’s Assessment at Rest at Week 12|The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 12 weeks thereafter at rest rated by the investigator. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.|12 weeks after injection|Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.||participants|||Number
778418|NCT00777803|Secondary|Responder by Investigator’s Assessment at Rest at Week 4|The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 4 weeks thereafter at rest rated by the investigator. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.|4 weeks after injection|Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.||participants|||Number
778419|NCT00777803|Secondary|Responder by Investigator’s Assessment at Maximum Frown at Week 12|The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 12 weeks thereafter at maximum frown rated by the investigator. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.|12 weeks after injection|Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.||participants|||Number
778420|NCT00777803|Secondary|Responder by Investigator’s Assessment at Maximum Frown at Week 4|The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 4 weeks thereafter at maximum frown rated by the investigator. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.|4 weeks after injection|Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.||participants|||Number
778421|NCT00777803|Secondary|Responder by Independent Rater's Assessment at Rest at Week 12|The Outcome Measure Data Table describes the number of responders. A subject is a responder if at least 2 out of 3 independent rater identified a response. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 12 weeks thereafter at rest. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.|12 weeks after injection|Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.||participants|||Number
778422|NCT00777803|Secondary|Responder by Independent Rater's Assessment at Rest at Week 4|The Outcome Measure Data Table describes the number of responders. A subject is a responder if at least 2 out of 3 independent rater identified a response. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 4 weeks thereafter at rest. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.|4 weeks after injection|Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.||participants|||Number
778423|NCT00777803|Secondary|Responder by Independent Rater's Assessment at Maximum Frown at Week 12|The Outcome Measure Data Table describes the number of responders. A subject is a responder if at least 2 out of 3 independent rater identified a response. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 12 weeks thereafter at maximum frown. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.|12 weeks after injection|Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.||participants|||Number
778424|NCT00777803|Primary|Responder by Independent Rater's Assessment at Maximum Frown at Week 4|The Outcome Measure Data Table describes the number of responders. A subject is a responder if at least 2 out of 3 independent rater identified a response. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 4 weeks thereafter at maximum frown. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.|4 weeks after injection|Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.||participants|||Number
778425|NCT00777855|Secondary|Maximum Plasma Concentration (Cmax) of S-warfarin and R-warfarin|Blood collection 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours after warfarin dosing.|0-120 hours after warfarin dosing|Each of 10 participants received both treatments, in randomly assigned order, separated by a minimum of 14 days||ng/ml||Standard Deviation|Mean
778426|NCT00777855|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity of S-warfarin and R-warfarin|Analysis of all concentration-time data. Blood collection 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours after warfarin dosing.|0-120 hours after warfarin dosing|Each of 10 participants received both treatments, in randomly assigned order, separated by a minimum of 14 days||ng/ml*h||Standard Deviation|Mean
778427|NCT00777855|Primary|S- and R- Enantiomers of Warfarin (S-warfarin and R-warfarin) Area Under the Plasma Concentration-time Curve (AUC) From 0 to 12 Hours.|Uptake effects on warfarin pharmacokinetics during time period of hepatic organic anion-transporting polypeptide (OATP) inhibition by rifampin. Blood collection 1, 2, 4, 6, 8, and 12 hours after warfarin dosing.|0-12 hours after warfarin dosing|Each of 10 participants received both treatments separated by a minimum of 14 days; treatment sequence was randomly assigned||ng/ml*h||Standard Deviation|Mean
778428|NCT00777946|Secondary|Percentage of Participants Achieving a Systolic Blood Pressure Response|"After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit.
A Systolic Blood Pressure Response was defined as a mean sitting Systolic Blood Pressure (msSBP) <140 mmHg or a ≥ 20 mmHg reduction in msSBP from baseline."|8 weeks|Full Analysis Set (all randomized patients who received study drug). Three patients (1 in Aliskiren 300 mg/Amlodipine 10 mg group and 2 in the Aliskiren 300 mg/Amlodipine 5 mg group were excluded from the analysis due to lack of post-baseline assessment.||Percentage of participants|||Number
778429|NCT00777946|Secondary|Percentage of Participants Achieving a Diastolic Blood Pressure Response|"After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit.
A Diastolic Blood Pressure Response was defined as a mean sitting Diastolic Blood Pressure (msDBP) <90 mmHg or a ≥ 10 mmHg reduction in msDBP from baseline."|8 weeks|Full Analysis Set (all randomized patients who received study drug). Three patients (1 in Aliskiren 300 mg/Amlodipine 10 mg group and 2 in the Aliskiren 300 mg/Amlodipine 5 mg group were excluded from the analysis due to lack of post-baseline assessment.||Percentage of participants|||Number
778430|NCT00777946|Secondary|Percentage of Participants Achieving Blood Pressure Control|"After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit.
Blood Pressure control was defined as having a mean sitting Diastolic Blood Pressure <90 and a mean sitting Systolic Blood Pressure <140."|8 weeks|Full Analysis Set (all randomized patients who received study drug). Three patients (1 in Aliskiren 300 mg/Amlodipine 10 mg group and 2 in the Aliskiren 300 mg/Amlodipine 5 mg group were excluded from the analysis due to lack of post-baseline assessment.||Percentage of participants|||Number
778431|NCT00777946|Secondary|Number of Participants With Serious Adverse Events and Adverse Events|"The number of participants with any Serious Adverse Event and the number of participants with Adverse Events in any system organ class.
Additional information about Adverse Events can be found in the Adverse Event Section."|8 weeks|Safety Population consisted of all randomized participants who received study drug.||participants|||Number
778432|NCT00777946|Secondary|Change From Baseline to End of Study in the Mean Sitting Systolic Blood Pressure (msSBP)|After the patient had been sitting for 5 minutes, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. The difference of the msSBP at baseline from the msSBP at 8 weeks was calculated using an ANCOVA model with baseline as a covariate and treatment and region as two factors.|Baseline, End of Study (Week 8)|Full Analysis Set (all randomized patients who received study drug). Three patients (1 in Aliskiren 300 mg/Amlodipine 10 mg group and 2 in the Aliskiren 300 mg/Amlodipine 5 mg group were excluded from the analysis due to lack of post-baseline assessment.||mm Hg||Standard Error|Least Squares Mean
778433|NCT00777946|Primary|Change From Baseline to End of Study in the Mean Sitting Diastolic Blood Pressure (msDBP)|After the patient had been sitting for 5 minutes, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. The difference of the msDBP at baseline from the msDBP at 8 weeks was calculated using an Analysis of Covariance (ANCOVA) model with baseline as a covariate and treatment and region as two factors.|Baseline, End of Study (Week 8)|Full Analysis Set (all randomized patients who received study drug). Three patients (1 in Aliskiren 300 mg/Amlodipine 10 mg group and 2 in the Aliskiren 300 mg/Amlodipine 5 mg group were excluded from the analysis due to lack of post-baseline assessment.||mm Hg||Standard Error|Least Squares Mean
778434|NCT00778102|Secondary|Percentage of Participants With Complications Related to Second Resective Surgery|Complications related to the second resective surgery were evaluated using the NCI-CTCAE version 3.0, and classified according to severity. The NCI-CTCAE severity classification criteria are as follows: Grade 5 = resulting in death; Grade 4 = life-threatening; Grade 3 = severe; Grade 2 = moderate; and Grade 1 = mild. The percentage of participants experiencing a given AE by severity grade was calculated as [number of participants with an AE divided by the number of participants who underwent second resective surgery] multiplied by 100.|Up to 5 years (at time of surgery; 48 hours and 4 and 12 weeks after surgery; within 4 weeks after completion of treatment; every 3 to 6 months for 1 year; then annually)|Safety Population (Second Surgery Subpopulation): All participants who underwent a second resective surgery and who received at least one dose of trial medication, whether prematurely withdrawn or not. Participants were analyzed according to the actual treatment they received.||percentage of participants|||Number
778435|NCT00778102|Secondary|Percentage of Participants With Complications Related to First Resective Surgery|Complications related to the first resective surgery were evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3.0, and classified according to severity. The NCI-CTCAE severity classification criteria are as follows: Grade 5 equals (=) resulting in death; Grade 4 = life-threatening; Grade 3 = severe; Grade 2 = moderate; and Grade 1 = mild. The percentage of participants experiencing a given adverse event (AE) by severity grade was calculated as [number of participants with an AE divided by the number of participants who underwent first resective surgery] multiplied by 100.|Up to 5 years (at time of surgery; 48 hours and 4 and 12 weeks after surgery; within 4 weeks after completion of treatment; every 3 to 6 months for 1 year; then annually)|Safety Population (First Surgery Subpopulation): All participants who underwent a first resective surgery and who received at least one dose of trial medication, whether prematurely withdrawn or not. Participants were analyzed according to the actual treatment they received.||percentage of participants|||Number
778436|NCT00778102|Secondary|Time to Response|Time to response according to RECIST version 1.0 was defined as the time from randomization to the date of first documented CR or PR. Participants were considered to have achieved CR upon the disappearance of all target and non-target lesions. Participants who achieved PR demonstrated at least a 30% decrease in the sum of the largest diameter of target lesions, taking as reference the Screening sum largest diameter. Responses were confirmed by repeat assessments no less than 4 weeks after criteria for response were first met. For participants who did not complete a confirmatory tumor assessment, time to response was censored at the date of last tumor assessment, or if unavailable, at the date of first dose. Time to response was estimated by Kaplan-Meier analysis.|Up to 5 years (at Screening; every 6 weeks, and within 4 weeks prior to surgery; 4 and 12 weeks after surgery; and at the end of Cycles 4 and 8 if assessed as R0 or R1, or every 6 weeks until progression or resectability if assessed as R2)|ITT Population||months||95% Confidence Interval|Median
778437|NCT00778102|Secondary|Percentage of Participants With a Confirmed Best Overall Response of Complete Response (CR) or Partial Response (PR) According to RECIST Version 1.0|Using RECIST version 1.0, participants were considered to have achieved CR upon the disappearance of all target and non-target lesions. Participants who achieved PR demonstrated at least a 30% decrease in the sum of the largest diameter of target lesions, taking as reference the Screening sum largest diameter. Responses were confirmed by repeat assessments no less than 4 weeks after criteria for response were first met. The collective percentage of participants with confirmed best overall response of CR or PR was calculated as [number of participants meeting RECIST criteria for CR or PR divided by the number of participants analyzed] multiplied by 100. Associated 95% confidence intervals were calculated for one-sample binomial using the Clopper-Pearson method.|Up to 5 years (at Screening; every 6 weeks, and within 4 weeks prior to surgery; 4 and 12 weeks after surgery; and at the end of Cycles 4 and 8 if assessed as R0 or R1, or every 6 weeks until progression or resectability if assessed as R2)|ITT Population||percentage of participants||95% Confidence Interval|Number
778438|NCT00778102|Secondary|Overall Survival (OS)|OS was defined as the time from randomization to death from any cause. For participants without an event of death, OS was censored at the last-known alive date. OS was estimated by Kaplan-Meier analysis.|Up to 5 years (prior to each cycle, and within 7 days prior to surgery; at time of surgery; 48 hours and 4 and 12 weeks after surgery; within 4 weeks after completion of treatment; every 3 to 6 months for 1 year; then annually)|ITT Population||months||95% Confidence Interval|Median
778439|NCT00778102|Secondary|Percentage of Participants Who Died||Up to 5 years (prior to each cycle, and within 7 days prior to surgery; at time of surgery; 48 hours and 4 and 12 weeks after surgery; within 4 weeks after completion of treatment; every 3 to 6 months for 1 year; then annually)|ITT Population||percentage of participants|||Number
778440|NCT00778102|Secondary|Progression-Free Survival (PFS)|PFS was defined, using RECIST version 1.0, as the time from randomization to the date of first documented PD or death from any cause. PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, or the appearance of one or more new lesions. For participants without documented PD or death, PFS was censored at the time of last tumor assessment. PFS was estimated by Kaplan-Meier analysis.|Up to 5 years (at Screening; every 6 weeks, and within 4 weeks prior to surgery; 4 and 12 weeks after surgery; and at the end of Cycles 4 and 8 if assessed as R0 or R1, or every 6 weeks until progression or resectability if assessed as R2)|ITT Population||months||95% Confidence Interval|Median
779758|NCT00793650|Primary|Safety and Engraftment|Peripheral blood progenitor cells were collected with either chemo-mobilization (27 of 39, 69%) or growth factor mobilization (12 of 39, 31%). Patients received an average of 9.0 × 10^6/kg CD34+ cells (range, 2.3-65) as their transplant graft.|Day 30 after transplant|As per the protocol||days||Full Range|Median
778441|NCT00778102|Secondary|Percentage of Participants Experiencing Death or Disease Progression|PD was defined, using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, as at least a 20% increase in the sum of the longest diameter of target lesions, or the appearance of one or more new lesions. The percentage of participants experiencing PD or death was calculated as [number of participants with event divided by the number of participants analyzed] multiplied by 100.|Up to 5 years (at Screening; every 6 weeks, and within 4 weeks prior to surgery; 4 and 12 weeks after surgery; and at the end of Cycles 4 and 8 if assessed as R0 or R1, or every 6 weeks until progression or resectability if assessed as R2)|ITT Population||percentage of participants|||Number
778442|NCT00778102|Secondary|Relapse-Free Survival (RFS)|RFS was defined as the time from curative resection (complete resection [R0] or microscopic residual tumor [R1]) to the date of first diagnosis of relapse. For participants with curative resection and without relapse, RFS was censored at the last known relapse-free assessment. RFS was estimated by Kaplan-Meier analysis.|Up to 5 years (at time of surgery; 48 hours and 4 and 12 weeks after surgery; within 4 weeks after completion of treatment; every 3 to 6 months for 1 year; then annually)|ITT Population; only participants with a residual tumor classification of R0 or R1 after first resection were included in the analysis.||months||95% Confidence Interval|Median
778443|NCT00778102|Secondary|Percentage of Participants Experiencing Relapse Following Curative Resection|Among participants with curative resection (complete resection [R0] or microscopic residual tumor [R1]), relapse was defined as the first new occurrence of cancer or death. The percentage of participants who experienced relapse was calculated as [number of participants with a relapse event divided by the number of participants initially classified as R0 or R1 following resective surgery] multiplied by 100.|Up to 5 years (at time of surgery; 48 hours and 4 and 12 weeks after surgery; within 4 weeks after completion of treatment; every 3 to 6 months for 1 year; then annually)|ITT Population; only participants with a residual tumor classification of R0 or R1 after first resection were included in the analysis.||percentage of participants|||Number
778444|NCT00778102|Secondary|Percentage of Participants With Complete or Major Histopathological Response|At the time of resective surgery, participants were evaluated for histopathological response as defined through pathologist review of the resected metastatic lesions, including assessment of margin status and tumor cell viability. Histopathological response classification was based upon the percentage of viable tumor cells, as described previously. The collective percentage of participants assessed as having a complete or major response was calculated as [number of participants with complete or major response divided by the number of participants who completed the assessment] multiplied by 100. Associated 95% confidence intervals were calculated for one-sample binomial using the Clopper-Pearson method.|Up to 5 years (at Screening; every 6 weeks, and within 4 weeks prior to surgery; and at time of/after surgery)|ITT Population; only participants with a histopathological assessment after the first resective surgery were included in the analysis.||percentage of participants||95% Confidence Interval|Number
778445|NCT00778102|Secondary|Percentage of Participants With Histopathological Response|At the time of resective surgery, participants were evaluated for histopathological response as defined through pathologist review of the resected metastatic lesions, including assessment of margin status and tumor cell viability. Histopathological response classification was based upon the percentage of viable tumor cells, where 'Complete response' was considered for those with 0 percent (%) viable tumor cells, 'Major response' for those with 1% to 49% viable tumor cells, 'Minor response' for 50% to 99% viable tumor cells, and 'No response' for 100% viable tumor cells. The response could not be determined in some cases and was documented as 'Unknown.' The percentage of participants within each response category was calculated as [number of participants with a given response divided by the number of participants who completed the assessment] multiplied by 100.|Up to 5 years (at Screening; every 6 weeks, and within 4 weeks prior to surgery; and at time of/after surgery)|ITT Population; only participants with a histopathological assessment after the first resective surgery were included in the analysis.||percentage of participants|||Number
778446|NCT00778102|Secondary|Time to Resection|Time to resection was defined as the time from randomization to the date of first resective surgery. For participants who did not undergo resective surgery, time to resection was censored at Day 1. Time to resection was estimated by Kaplan-Meier analysis.|Up to 5 years (at Screening; prior to each cycle, and within 7 days prior to surgery; and at time of surgery)|ITT Population||months||95% Confidence Interval|Median
778447|NCT00778102|Primary|Percentage of Participants With Complete Resection or Residual (Microscopic or Macroscopic) Tumor|Following resective surgery, participants were evaluated for complete resection (R0) or the presence of microscopic (R1) or macroscopic (R2) residual tumor. The percentage of participants within each residual tumor classification was calculated as [number of participants with R0, R1, and/or R2 divided by the total number of participants] multiplied by 100. Associated 95% confidence intervals were calculated for one-sample binomial using the Clopper-Pearson method.|Up to 5 years (at Screening; every 6 weeks, and within 4 weeks prior to surgery; and at time of/after surgery)|ITT Population||percentage of participants||95% Confidence Interval|Number
778448|NCT00778167|Primary|Safety and Tolerability of IMC-A12 in Combination With Erlotinib Hydrochloride as Graded by Common Terminology Criteria for Adverse Event (CTCAE) Version 3.0 (DLTs During Cycle One)|Patients were evaluable for cohort dose escalation/de-escalation decision making either if they experienced DLTs in cycle 1 or if they had completed 24 of the planned 28 days (85%) dosing of erlotinib and three of the four planned days of weekly dosing of cixutumumab (75%) in cycle 1 in cohorts 1 and 2 in the absence of DLTs. In cohort 3, patients were evaluable for tolerability if they had completed 18 days (85%) dosing of erlotinib and had received the planned day 1 dose of cixutumumab.|From time of first dose up to 28 days|Patients were evaluated with history, physical examination, vital signs, and blood tests weekly through cycle 1 and on day 1 of each subsequent cycle. Incidence and severity of AEs were collected at each study visit and graded according to National Cancer Institute Common Toxicity Criteria for Adverse Events version 3.||Participants|||Number
778449|NCT00778258|Secondary|Changes in Mechanistic Values [Humoral, T Cell and Basophil]|This outcome measure was not well defined in the protocol and was not analyzed.|Baseline to the time complete milk tolerance was established|Data were not collected and therefore no analyses could be performed.|||||
778450|NCT00778258|Secondary|Changes in Mechanistic Values [Humoral, T Cell and Basophil]|This outcome measure was not well defined in the protocol and was not analyzed.|Baseline, Month 12, Month 24, and Month 36|Data were not collected and therefore no analyses could be performed.|||||
778451|NCT00778258|Secondary|Comparison of Percent of Participants Tolerant to Non-heated Milk Between the Participants Who Ingested Baked-milk Products and Participants Who Continued to Avoid All Forms of Milk|Participants were grouped based on the food they reacted to, at the baseline Oral Food Challenge (OFC). Group 1= reacted to muffin; Group 2= reacted to pizza; Group 3= reacted to rice pudding; Group 4= reacted to non-baked milk; Group 5= did not react. Groups 2- 4 were randomized to dose escalation or maintenance, and Group 1, and a Control group that chose not to participate in the study, continued to avoid milk. Randomized participants performed an OFC at each visit during which they were given progressively less denatured/ baked milk protein food items until they had an allergic reaction. Participants were considered tolerant to unheated cow's milk if at any post-randomization visit up through 36 months, they did not react to any food, including unheated whole milk. Tolerance of non-heated milk was assessed by report among those who continued to avoid milk.|Month 36|Randomized and comparison participants||percent participants|||Number
778452|NCT00778258|Secondary|Relationship Between Dose of Baked-milk Protein and Reactivity to Casein Versus Whey|Participants were grouped based on the food to which they experienced a reaction at the baseline Oral Food Challenge (OFC). Group 1 = reacted to muffin; Group 2 = reacted to pizza; Group 3 = reacted to rice pudding; Group 4 = reacted to non-baked milk; Group 5 = did not react. Groups 2, 3 and 4 were randomized to dose escalation or maintenance, and at each visit following randomization, participants performed an OFC where they were given food products containing milk protein denatured through baking. Participants were given progressively less denatured milk protein food items until they had an allergic reaction. The relationship between serum IgE to betalactoglobulin and casein, and the food level at which the participant reacted, were evaluated at each post randomization OFC visit. It is expected that those who reacted to muffin would have a higher ratio of casein to betalactoglobulin than those who reacted to less heated forms of milk.|Baseline, Month 12, Month 24, Month 36|Intent-to-treat||Ratio||Inter-Quartile Range|Median
778453|NCT00778258|Secondary|Relationship Between Initial Dose of Tolerated Baked-milk Protein and Time to Complete Tolerance|Participants were grouped based on the food to which they experienced a reaction at the baseline Oral Food Challenge (OFC). Group 1 = reacted to muffin; Group 2 = reacted to pizza; Group 3 = reacted to rice pudding; Group 4 = reacted to non-baked milk; Group 5 = did not react. Groups 2, 3 and 4 were randomized to dose escalation or maintenance, and at each visit following randomization, participants performed an OFC where they were given food products containing milk protein denatured through baking. Participants were given progressively less denatured milk protein food items until they had an allergic reaction. Participants were considered to become tolerant to unheated cow's milk if at any post-randomization visit up through 36 months, they did not react to any food, including unheated whole milk.|Randomization through end of study (up to 36 months)|Randomized intent-to-treat participants who achieved tolerance||months||Standard Deviation|Mean
778454|NCT00778258|Secondary|Comparison of Baseline Mechanistic Studies [Treg and Basophil] With the Outcome of the Baseline OFC to Identify the Biomarkers of Clinical Reactivity|This endpoint evaluates the correlation between the mechanistic biomarker of the number of basophils and T regulatory cells reactive to milk proteins and the food to which participants reacted at baseline. Participants were grouped according to food at which participants experienced a reaction during their baseline oral food challenge: Group 1 = reacted to muffin; Group 2 = reacted to pizza; Group 3 = reacted to rice pudding; Group 4 = reacted to non-baked milk; Group 5 = did not react. Quantitative IgE to milk proteins was done using FEIA (UniCAP) on serum from blood drawn at baseline.|Baseline|Intent-to-treat||cells/µL||Inter-Quartile Range|Median
778455|NCT00778258|Secondary|Comparison of Baseline IgE With the Outcome of the Baseline OFC to Identify the Biomarkers of Clinical Reactivity|This endpoint evaluates the correlation between the mechanistic biomarker of IgE to milk proteins and allergic reaction at baseline. Participants were grouped according to food at which participants experienced a reaction during their baseline oral food challenge: Group 1 = reacted to muffin; Group 2 = reacted to pizza; Group 3 = reacted to rice pudding; Group 4 = reacted to non-baked milk; Group 5 = did not react. Quantitative IgE to milk proteins was done using FEIA (UniCAP) on serum from blood drawn at baseline.|Baseline|Intent-to-treat||kUa/L||Inter-Quartile Range|Median
778456|NCT00778258|Secondary|Comparison of Baseline Basophil Percent Maximal Degranulation With the Outcome of the Baseline OFC to Identify the Biomarkers of Clinical Reactivity|This endpoint evaluates the correlation between the mechanistic biomarkers of basophil reactivity and the food to which participants reacted at baseline. Participants were grouped according to food at which participants experienced a reaction during their baseline oral food challenge: Group 1 = reacted to muffin; Group 2 = reacted to pizza; Group 3 = reacted to rice pudding; Group 4 = reacted to non-baked milk; Group 5 = did not react. Basophils come from blood drawn at baseline. Basophils counts were done using whole blood specimens. Basophil reactivity as measured as maximal degranulation percentage after stimulation with titrated dilutions of milk powder (from 1x103 to 1x10-1 µg/mL total protein) and was correlated to group assignment using Spearman correlation coefficients.|Baseline|Intent-to-treat||percentage of max basophil degranulation||Inter-Quartile Range|Median
778457|NCT00778258|Secondary|Percent of Participants Becoming Tolerant to Unheated Cow's Milk|Participants were grouped based on the food to which they experienced a reaction at the baseline Oral Food Challenge (OFC). Group 1 = reacted to muffin; Group 2 = reacted to pizza; Group 3 = reacted to rice pudding; Group 4 = reacted to non-baked milk; Group 5 = did not react. Groups 2, 3 and 4 were randomized to dose escalation or maintenance, and at each visit following randomization, participants performed an OFC where they were given food products containing milk protein denatured through baking. Participants were given progressively less denatured milk protein food items until they had an allergic reaction. Participants were considered to become tolerant to unheated cow's milk if at any post-randomization visit up through 36 months, they did not react to any of the food given in the OFC.|Randomization through end of study (up to 36 months)|Randomized intent-to-treat||percentage of participants|||Number
778469|NCT00778375|Primary|Complete Remission (CR) Rate for First 60 Participants|All responses were defined as per IWG criteria (2003) where CR Rate defined as number of participants with CR out of total treated participants. Complete remission (CR): Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count > 1.0 times 10^9/L and platelet count > 100 times 10^9/L, and normal bone marrow differential (< 5% blasts). Bone marrow aspirate and/or biopsy starting on day 21 (+/- 7 days) of therapy.|Evaluation following two 10 day cycles on day 21 of therapy, continuing up to 210 days|The outcome population consisted of first sixty participants enrolled between October 2008 and January 2010, of whom 59 were evaluable for response.||Percentage of Participants|||Number
778458|NCT00778258|Secondary|Percent of Participants Becoming Tolerant to Unheated Cow's Milk at 12, 24, and 36 Months|Participants were grouped based on the food to which they experienced a reaction at the baseline Oral Food Challenge (OFC). Group 1 = reacted to muffin; Group 2 = reacted to pizza; Group 3 = reacted to rice pudding; Group 4 = reacted to non-baked milk; Group 5 = did not react. Groups 2, 3 and 4 were randomized to dose escalation or maintenance, and at each visit following randomization, participants performed an OFC where they were given food products containing milk protein denatured through baking. Participants were given progressively less denatured milk protein food items until they had an allergic reaction. Participants were considered to become tolerant to unheated cow's milk if at the specified visit, they did not react to any of the foods given in the OFC.|12 months, 24 months, and 36 months|Randomized intent-to-treat||percentage of participants|||Number
778459|NCT00778258|Secondary|Number of Participants With a Positive Progression in Tolerating More Allergenic Forms of Milk at 12 and 24 Months|Participants were grouped based on the food they experienced a reaction to at the baseline Oral Food Challenge (OFC). Group 1 = reacted to muffin; Group 2 = reacted to pizza; Group 3 = reacted to rice pudding; Group 4 = reacted to non-baked milk; Group 5 = did not react. Groups 2, 3 and 4 were randomized to dose escalation or maintenance, and at each visit following randomization, performed an OFC where food products containing milk protein denatured through baking were given. Participants were given progressively less denatured milk protein food items until an allergic reaction occurred. A positive progression in tolerance of baked milk was defined as a reaction to a less denatured milk protein food at 12 months than at baseline. Positive progression at 24 months was defined as experiencing a reaction to a less denatured milk protein food at 24 months than at 12 months.|12 months, 24 months|Randomized intent-to-treat||participants|||Number
778460|NCT00778258|Primary|Number of Participants With a Positive Progression in Tolerance of Baked Milk and Ultimately Unheated Milk in Dose Escalation Sub-arm Compared to Maintenance Sub-arm|Participants were grouped based on the food to which they experienced a reaction at the baseline Oral Food Challenge (OFC). Group 1=reacted to muffin; Group 2=reacted to pizza; Group 3=reacted to rice pudding; Group 4=reacted to non-baked milk; Group 5=did not react. Groups 2, 3, and 4 were randomized to dose escalation or maintenance, and at each visit following randomization, participants performed an OFC where they were given food products containing milk protein denatured through baking. Participants were given progressively less denatured milk protein food items until they had an allergic reaction. Participants were considered to have a positive progression in tolerance of baked milk if they experienced a reaction to a less denatured milk protein food item at any post randomization visits than the one to which they reacted at their baseline visit.|Randomization through end of study (up to 36 months)|Randomized intent-to-treat||participants|||Number
778461|NCT00778310|Primary|Brain Oxygenation Level Dependent Signal in the Fusiform Gyrus and the Amygdala on Concerta vs. Placebo|Each subject viewed shapes and faces on multiple trials. The subject matched faces or shapes on each trial. BOLD activity during shape trials was subtracted from BOLD activity during Face trials and this value was compared on drug vs. placebo trials.|Placebo and Drug day, 1-2 weeks apart|The number who completed both fMRI one week apart (crossover study, scanned twice||Face-Shape BOLD signal difference||Standard Deviation|Mean
778462|NCT00778336|Secondary|Description of Treatments by Thrombotic Condition|The # of patients that were exposed to each treatment at least once in the given thrombotic condition.|Index Procedure|||Participants|||Number
778463|NCT00778336|Secondary|Rethrombosis|The number of patients that had rethrombosed in the vessels treated during the index procedure (initial endovascular procedure).|3 Month Follow Up|||Participants|||Number
778464|NCT00778336|Primary|Change From Baseline to Final Angiographic Results|"From the Index Procedure's Baseline (pre-endovascular treatment) and Final (post-endovascular treatment) angiograms,each vessel was assigned a value by the treating physician:
complete occlusion (> 90% occlusion);
substantial occlusion (50-90% occlusion OR <50% occlusion and >3cm in length);
partial occlusion (<50% occlusion AND <3cm in length);
patent (Without visable thrombus or occlusion).
The levels of change (improvement) were calculated by subtracting the baseline assigned angiographic value from the final value."|Index Procedure ( pre-endovascular treatment and post-endovascular treatment)|Intention to Treat (ITT)||Occlusion Index||Standard Error|Mean
778465|NCT00778375|Secondary|Overall Response Rate (CR, CRp/CRi and PR)|IWG Response criteria (2003): Complete remission (CR): Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count > 1.0 times 10^9/L and platelet count > 100 times 10^9/L, and normal bone marrow differential (< 5% blasts). Complete Remission without Platelet Recovery (CRp): Peripheral blood and bone marrow results as for CR, but with platelet counts of < 100 x 10^9/L or Complete remission with incomplete marrow recovery (CRi), defined as CR above, but without normal blood counts; Partial Remission (PR): Blood count recovery as for CR, but with both a decrease in marrow blasts of at least 50% and not more than 6 to 25% abnormal cells in the marrow. Participants not achieving a complete remission following first induction course, can receive a second induction course at least 28 days following first to optimize response if possible.|Beginning assessment following two 10-day induction cycles through an additional re-induction cycle, up to 40 days|Of 119 enrolled, one participant was not evaluable for response.||Percentage of Participants|||Number
778466|NCT00778375|Secondary|Event Free Survival (EFS)|EFS is defined as length of time after primary treatment for a cancer ends that the participant remains free of certain complications or events that the treatment was intended to prevent or delay, for example but not exclusive of hematologic and non-hematologic toxicities, cumulative toxicities with consolidation courses, or emergence of resistance to the chemotherapy component of treatment.|Follow up up to 5 years/60 months.|Of 119 enrolled, one participant was not evaluable for response.||Months||Full Range|Median
778467|NCT00778375|Primary|Number of Participants With Complete Remission [Complete Response (CR), Complete Response With Platelet Recover (CRp) or Complete Response With Incomplete Marrow Recovery (CRi)]|All responses were defined as per IWG criteria (2003) where CR Rate defined as number of participants with CR out of total treated participants. Complete remission (CR): Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count > 1.0 times 10^9/L and platelet count > 100 times 10^9/L, and normal bone marrow differential (< 5% blasts). Complete response with incomplete marrow recovery (CRi), defined as CR above, but without normal blood counts. Bone marrow aspirate and/or biopsy starting on day 21 (+/- 7 days) of therapy.|Beginning assessment following two 10-day induction cycles through an additional re-induction cycle, up to 40 days|One participant of 119 treated was not evaluable for response. Twenty-two participants required re-induction.||Participants|||Number
778470|NCT00778375|Primary|Disease-free (DFS) or Relapse-free Survival (RFS) Time|Disease (DFS) or Relapse-free survival (RFS): Time from date of treatment start until the date of first objective documentation of disease-relapse; Bone marrow aspirate and/or biopsy starting on day 21 (+/- 7 days) of therapy and then every 2 weeks (+/- 7 days) as required by leukemia evolution until remission or non-response. Among participants who achieved CR or CRp, RFS was defined as the time interval between the date of response (ie CR or CRp) and the date of relapse or date of death, whichever occurs first. CR or CRp participants who were alive and relapse-free were censored at the off-study date. Full range reflects time to disease progression only, therefore does not reflect a lesser survival time due to other reasons than disease progression/relapse.|Evaluated from treatment date until date of disease progression/relapse, followed for 5 years/60 months.|One participant of 119 treated was not evaluable for outcome.||Months||Full Range|Median
778471|NCT00772304|Secondary|Taste and Aftertaste of Medication||5 min, 45 min.||||||
778472|NCT00772304|Primary|Product Preference Questionnaire for Immediate Taste|Using a set of coded responses, subjects evaluated product preference in regards to immediate taste|5 min post-dose|||Percentage of participants|||Number
778473|NCT00772369|Primary|Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine.|"SAE: any untoward medical occurrence with the following outcomes:
death,
a life-threatening adverse drug experience (as confirmed by the investigators),
inpatient hospitalization or prolongation of existing hospitalization,
a persistent or significant disability/incapacity, or
a congenital anomaly/birth defect. Medical conditions that required 3 or more office or emergency room visits, and diagnosis by a physician of low blood cell count or low platelet count, swelling or redness of the joints, asthma, diabetes, or autism were also solicited. (MedDRA Version 6.0)"|6 Months post 4th dose vaccination|Response to questionnaire that were confirmed by the primary care physician’s office were analyzed, Primary Analysis Population. Unconfirmed safety data form 29 participants were excluded from the primary analysis.||Participants|||Number
778474|NCT00772369|Primary|Number of Participants Who Had Positive Response to the Solicited Adverse Events Questionnaire Post 4th Dose of the Pentacel® Vaccination Series|"Positive response is a 'Yes' to any of the following questions:
Has your child been admitted to a hospital?
Has your child experienced an illness that made you fear for his/her life (life-threatening episode) that required attendance to the Emergency Room or a Physician’s office?
Has your child developed a medical condition that required 3 or more office or emergency room visits for that condition?
Has your child been diagnosed by a physician as having:
Low blood count or low platelet count? Swelling or redness of the joints? Asthma? Diabetes? Autism?"|6 months post 4th dose vaccination|Participants who completed the whole survey. Those who had confirmed data, or had data that did not require confirmation, or had unconfirmed data.||Particpants|||Number
778475|NCT00772382|Secondary|The Change in Serum Phosphorus From Baseline to Week 52||52 weeks|Intent-to-treat (ITT) with last observation carried forward (LOCF). (ITT population included all enrolled subjects who took at least one dose of study medication and had at least one post-enrollment efficacy value after the start of study medication.)||mg/dL||95% Confidence Interval|Mean
778476|NCT00772382|Primary|Number of Adverse Events (AE)||52 weeks|||participants|||Number
778477|NCT00772447|Secondary|Per-pathogen(Staphylococcus Aureus) Microbiological Response at TOC|This is the comparison of clinical efficacy by staphylococcus aureus between the two groups. As the analysis was performed by specific pathogen in ME population and clinical efficacy was compared meanwhile, the clinical evaluation was based on the number of cases under the category of specific pathogen rather than the number of strains. Percentage of patients who were cured or improved at TOC visit in the patients who were identified with staphylococcus aureus infection at baseline of both groups.|baseline and TOC(test of cure), for up to 4 weeks|There were 48 patients indentified staphylococcus aureus infection both in daptomycin group and in comparator group.||Percentage of patients|||Number
778478|NCT00772447|Secondary|Per-pathogen(Methicillin Sensitive Staphylococcus Aureus) Clinical Response at TOC|This is the comparison of clinical efficacy by methicillin sensitive staphylococcus aureus(MSSA) between the two groups. As the analysis was performed by specific pathogen in ME population and clinical efficacy was compared meanwhile, the clinical evaluation was based on the number of cases under the category of specific pathogen rather than the number of strains. Percentage of patients who were cured or improved at TOC visit in the patients who were identified with MSSA infection at baseline of both groups.|baseline and TOC(test of cure), for up to 4 weeks|There were 33 patients indentified MSSA infection in daptomycin group and 37 patients indentified with MSSA in comparator group.||Percentage of patients|||Number
778479|NCT00772447|Secondary|Per-pathogen(Methicillin Resistant Staphylococcus Aureus) Clinical Response at TOC(Test of Cure)|This is the comparison of clinical efficacy by methicillin resistant staphylococcus aureus(MRSA) between the two groups. As the analysis was performed by specific pathogen in ME population and clinical efficacy was compared meanwhile, the clinical evaluation was based on the number of cases under the category of specific pathogen rather than the number of strains. Percentage of patients who were cured or improved at TOC visit in the patients who were identified with MRSA infection at baseline of both groups.|baseline and TOC, for up to 4 weeks|There were 14 patients indentified MRSA infection in daptomycin group and 10 patients indentified with MRSA in comparator group.||Percentage of patients|||Number
778480|NCT00772447|Secondary|Microbiological Response at EOT(End of Therapy)|The microbiological response rate (removal or presumed removal) in ME(microbiological evaluable) population of daptomycin group and comparator group at EOT visit was analyzed. ME population includes all the patients with Gram-positive pathogenic bacteria isolated at baseline in CE population. Microbiological response rate means the percentage of strains which were removed or presumably removed at EOT visit in all the strains isolated from ME population at baseline.|baseline and EOT, for up to 2 weeks|ME population includes all the patients with Gram-positive pathogenic bacteria isolated at baseline in CE population. There were 86 strains isolated from 81 patients in daptomycin arm and 88 strains from 81 patients in comparator arm who met the criteria of ME population at EOT visit.||Percentage of strains|Participants||Number
778514|NCT00780910|Primary|The Percentage of Subjects Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)||After 24 weeks of follow-up|||percentage of subjects achieving SVR||95% Confidence Interval|Number
791694|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Alkaline Phosphatase [ALP])||Baseline up to Month 7|||percentage of participants|||Number
778481|NCT00772447|Secondary|Microbiological Response at TOC(Test of Cure)|The microbiological response rate (removal or presumed removal) in ME(microbiological evaluable) population of daptomycin group and comparator group at TOC visit was analyzed. ME population includes all the patients with Gram-positive pathogenic bacteria isolated at baseline in CE population. Microbiological response rate means the percentage of strains which were removed or presumably removed at TOC visit in all the strains isolated from ME population at baseline.|baseline and TOC, for up to 4 weeks|ME population includes all the patients with Gram-positive pathogenic bacteria isolated at baseline in CE population. There were 83 strains isolated from ME population of daptomycin arm(78 patients) and 86 strains from ME population in comparator arm(79 patients).||Percentage of strains|Participants||Number
778482|NCT00772447|Secondary|Blinded Investigator's Assessement of Clinical Response at EOT(End of Therapy)|The percentage of patients who were cured or clinically improved in the clinical evaluable (CE) population at EOT visit was analyzed. CE population includes all the patients with no significant deviation from study protocol in full analysis set population, and meetting the following specific criteria: 1.receiving randomly dispensed study treatment at appropriate time(with a compliance of at least 80% or 4 days [3 days for patients evaluated as treatment failure]). 2.without the administration of potentially confounding non-investigational antibiotics (using one potentially effective non-investigational antibiotic for the treatment of primary infection due to other reasons than lack of efficacy from Day 1 to TOC [for systemicadministration of non-glycopeptides, >1 calendar day]). 3.meeting the study inclusion/exclusion criteria 4.necessary clinical evaluation performed (evaluation for effectiveness at TOC visit, except for the condition confirmed as clinically ineffective)|baseline and EOT(end of therapy), for up to 2 weeks|There were 110 patients in daptomycin arm and 103 patients in comparator arm who both completed EOT visit and met the criteria of CE population||Percentage of patients|||Number
778483|NCT00772447|Secondary|Blinded Investigator's Assessement of Clinical Response at TOC(Test of Cure)|The percentage of patients who were cured or clinically improved in the clinical evaluable (CE) population of each arm at TOC visit was analyzed. CE population includes all the patients with no significant deviation from study protocol in full analysis set population, and meetting the following specific criteria: 1.receiving randomly dispensed study treatment at appropriate time(with a compliance of at least 80% or 4 days [3 days for patients evaluated as treatment failure]). 2.without the administration of potentially confounding non-investigational antibiotics (using one potentially effective non-investigational antibiotic for the treatment of primary infection due to other reasons than lack of efficacy from Day 1 to TOC [for systemicadministration of non-glycopeptides, >1 calendar day]). 3.meeting the study inclusion/exclusion criteria 4.necessary clinical evaluation performed (evaluation for effectiveness at TOC visit, except for the condition confirmed as clinically ineffective)|baseline and TOC, for up to 4 weeks|There were 107 patients in daptomycin arm and 101 patients in comparator arm meeting the criteria of CE population and completed TOC visit.||percentage of patients|||Number
778484|NCT00772447|Primary|Shift in ECG|percentage of patients who were primarily tested as normal ECG at baseline and changed into abnormal ECG at TOC visit in all the patients with normal ECG at baseline|baseline to TOC(test of cure), for up to 4 weeks|Only patients who had both measurements at baseline and TOC visit and those who got normal ECG resluts at baseline were included in the summary. Change=TOC visit-baseline||percentage of patients|||Number
778485|NCT00772447|Primary|Change in Urine pH||baseline to TOC(test of cure), for up to 4 weeks|Only patients who had measurements were included in the summary of a specific parameter at a specific time point. Change = TOC visit - baseline||pH||Standard Deviation|Mean
778486|NCT00772447|Primary|Change in Serum Total Creatine Phosphokinase (CPK)||baseline to TOC(test of cure), for up to 4 weeks|Only patients who had measurements in both baseline and TOC visit were included for the analysis. Change=TOC visit-baseline||IU/L||Standard Deviation|Mean
778487|NCT00772447|Primary|Change in Creatinine Clearance||baseline to TOC(test of cure), for up to 4 weeks|Only patients who had measurements in both baseline and TOC visit were included for the analysis. Change=TOC visit-baseline||ml/min||Standard Deviation|Mean
778488|NCT00772447|Primary|Change of Erythrocyte Volume Fraction(Percentage of Erythrocyte Volume in Total Volume of Blood)|Erythrocyte volume fraction means under certain conditions, after centrifugation pressing, the percentage of erythrocyte volume in the total volume of blood|baseline to TOC(test of cure), for up to 4 weeks|Only patients who had measurements in both baseline and TOC visit were included for the analysis. Change=TOC visit-baseline||percentage||Standard Deviation|Mean
778489|NCT00778622|Other Pre-specified|Number of Participants Who Had a Normal Electrocardiogram (ECG) at Baseline and an ECG at Week 16 (or Termination Visit) Which Was Considered to be Abnormal With Clinical Significance - Safety Population|Baseline was defined as ECG obtained at the screening visit. A judgment of clinical significance was at the discretion of the investigator. Safety population included participants who enrolled in the study and took at least 1 dose of Glucophage XR.|Baseline to Week 16|number of participants with a normal ECG at baseline for normal weight, overweight, and obese arms were 71, 62, 65, respectively.||participants|||Number
778490|NCT00778622|Other Pre-specified|Mean Change From Baseline at Week 16 in Diastolic and Systolic Blood Pressure - Safety Population|Baseline was defined as the value obtained at screening or value obtained on Day 1 before treatment. Diastolic and systolic blood pressure was measured in millimeters of mercury (mm Hg). Safety population included participants who enrolled in the study and took at least 1 dose of Glucophage XR.|Baseline to Week 16|||mm Hg||Standard Deviation|Mean
778491|NCT00778622|Other Pre-specified|Mean Change From Baseline at Week at Week 16 in ECG Parameter Heart Rate (HR) - Safety Population|Baseline was defined as ECG obtained at the screening visit. ECG was 12-lead. Heart rate (HR) was measured in beats per minute (beats/min). Safety population included participants who enrolled in the study and took at least 1 dose of Glucophage XR.|Baseline to Week 16|Safety population included 125, 122, 124 participants in each arm, respectively. Participants missing from analysis for change at Week 16 for Heart Rate were 17, 18, 20 participants in the normal, overweight, obese arms, respectively.||beats/min||Standard Deviation|Mean
778492|NCT00778622|Other Pre-specified|Number of Participants With Clinically Significant Changes From Baseline at Week 16 in Urinalysis - Safety Population|Urinalysis included pH and specific gravity. Baseline defined as values obtained at screening visit. Clinically significant: outside the reference range (low/high)and judged to be significant by the investigator: Specific gravity 1.003 - 1.035; ph 5 - 8. Safety population included participants who enrolled in the study and took at least 1 dose of Glucophage XR.|Baseline to Week 16|||participants|||Number
778493|NCT00778622|Other Pre-specified|Number of Participants Who Had Abnormal Increase From Baseline at Week 16 in Kidney or Liver Function Serum Chemistry Values - Safety Population|Baseline defined as value obtained either in screening visit or last value obtained before glucophage XR treatment given on Day 1. Serum chemistries evaluating kidney or liver function: blood urea nitrogen(BUN), serum creatinine (SCr), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), total bilirubin (BR), uric acid (UA). Abnormal increase in kidney and liver function tests defined as 1.25 - less than, equal to (<=)2.6 times (x) upper limit of normal (ULN)in ALT, AST, total BR, UA; abnormal increase defined as 1.25 to <= 5.1 x ULN in BUN. Safety population included participants who enrolled in the study and took at least 1 dose of Glucophage XR.|Baseline to Week 16|Number of participants (normal, overweight, obese, respectively) who were missing values and were not included in the Week 16 analysis for the following serum chemistry tests: ALT = 14, 11, 13; AST = 14, 11, 13; total BR = 14, 11, 13; creatinine = 14, 12, 13; BUN = 14, 12, 13; UA = 14, 12, 13.||participants|||Number
778494|NCT00778622|Other Pre-specified|Number of Participants With Clinically Significant Changes From Baseline at Week 16 in the Hematology Laboratory Test Profile - Safety Population|Hematology profile = hematocrit, hemoglobin, red blood cell count (RBC), white blood cell count(WBC), lymphocytes, monocytes, basophils, eosinophils, neutrophils, platelet count. Baseline: value obtained at screening or last value obtained before treatment. LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Hemoglobin (g/dL): >3 g/dL decrease from preRX; hematocrit (%): <0.75*preRX; RBC (*10^6 c/uL): <0.75*preRX; platelet count (*10^9 c/uL): <0.67*LLN or >1.5*ULN, of if preRX<LLN, use 0.5*preRX and <100,000/mm^3; WBC (*10^3 c/uL): <0.75*LLN or >1.25*ULN, or if preRX <LLN, use <0.8*preRX or >ULN, or if preRX>ULN, use >1.2*preRX or <LLN; neutrophils+bands (*10^3 c/uL): if value <1.0*10^3 c/uL; eosinophils (*10^3 c/uL): if value >0.750*10^3 c/uL; basophils (*10^3 c/uL): if value >400/mm^3; monocytes (*10^3 c/uL): if value >2000/mm^3; lymphocytes (*10^3 c/uL): if value <0.750*10^3 c/uL or if value >7.50*10^3 c/uL.|Baseline to Week 16|Safety population included participants who enrolled in the study and took at least 1 dose of Glucophage XR.||participants|||Number
778495|NCT00778622|Other Pre-specified|Number of Participants With Episodes of Lactic Acidosis or Hypoglycemia From Day 1 to Week 16 - Safety Population|Day 1 was first day of treatment. Lactic acidosis defined as elevated blood lactate levels (>5 mmol/L), decreased blood pH, electrolyte disturbances with an increased anion gap, and increased lactate/pyruvate ratio. Hypoglycemia (low levels of blood glucose) was reported as an adverse event. Safety population included participants who had enrolled in the study and took at least 1 dose of glucophage extended release (glucophage XR). If a subject experienced more than one adverse event, the subject was counted once at the highest severity.|Day 1 to Week 16|All participants enrolled in the study and who received at least 1 dose of Glucophage XR.||participants|||Number
778496|NCT00778622|Secondary|Mean Change From Baseline at Week 16 (95% Confidence Interval) in Adiponectin - Full Analysis Set|Baseline was defined as value obtained on Day 1 (first day of treatment). Adiponectin was measured in milligrams/liter (mg/L) and values obtained through a central laboratory; normal range was 1.20 to 20.00 mg/L.|Baseline to Week 16|Full Analysis Set (FAS) included participants who were enrolled, took at least 1 study medication and had at least 1 post baseline HbA1c assessment. For this outcome measure, 78, 70, and 72 normal, overweight, obese participants, respectively, were missing and were not included in the analysis.||mg/L||95% Confidence Interval|Mean
778497|NCT00778622|Secondary|Mean Change From Baseline at Week 16 (95% Confidence Interval) in Plasminogen Activator Inhibitor-1 (PAI-1) - Full Analysis Set|Baseline was defined as value obtained on Day 1 (first day of treatment). PAI-1 (activity) was measured in units/milliliter (U/mL)and values obtained through a central laboratory; normal was less than 25.00 U/mL.|Baseline to Week 16|Full Analysis Set (FAS) population = 111, 111, 112 in normal, overweight, obese participants respectively. For this outcome measure, 84, 79, and 75 normal, overweight, obese participants, respectively, were missing and were not included in the analysis.||U/mL||95% Confidence Interval|Mean
778498|NCT00778622|Secondary|Mean Change From Baseline at Week 16 (95% Confidence Interval) in C-Reactive Protein (CRP) - Full Analysis Set|Baseline was defined as value obtained on Day 1 (first day of treatment). C-Reactive Protein (CRP) was measured in milligrams/liter (mg/L) and values were obtained through a central laboratory; normal was less than 5.0 mg/L.|Baseline to Week 16|Full Analysis Set (FAS) consisted of participants who were enrolled, took at least 1 study medication and had at least 1 post baseline HbA1c assessment. For this outcome measure, 102, 95, and 85 normal, overweight, obese participants, respectively, were missing and were not included in the analysis.||mg/L||95% Confidence Interval|Mean
778499|NCT00778622|Secondary|Mean Change From Baseline at Week 16 (95% Confidence Interval) in Fasting Triglycerides (TG) - Full Analysis Set|Baseline was defined as value obtained on Day 1 (first day of treatment). Triglycerides (TG) were measured in millimoles per liter (mmol/L)and values obtained through local laboratories.|Baseline to Week 16|Full Analysis Set (FAS) consisted of participants who were enrolled, took at least 1 study medication and had at least 1 post baseline HbA1c assessment. For this outcome measure, 1, 4, and 8 normal, overweight, obese participants, respectively, were missing and were not included in the analysis.||mmol/L||95% Confidence Interval|Mean
778500|NCT00778622|Secondary|Mean Change From Baseline at Week 16 (95% Confidence Interval) in Fasting High-density Lipoprotein Cholesterol (HDL-C) - Full Analysis Set|Baseline was defined as value obtained on Day 1 (first day of treatment). High-density lipoprotein cholesterol (HDL-C) was measured in millimoles per liter (mmol/L) and obtained through local laboratories.|Baseline to Week 16|Full Analysis Set (FAS) consisted of participants who were enrolled, took at least 1 study medication and had at least 1 post baseline HbA1c assessment. For this outcome measure, 2, 3, and 8 normal, overweight, obese participants, respectively, were missing and were not included in the analysis.||mmol/L||95% Confidence Interval|Mean
778501|NCT00778622|Secondary|Mean Change From Baseline at Week 16 (95% Confidence Interval) in Fasting Low-density Lipoprotein Cholesterol (LDL-C) - Full Analysis Set|Baseline was defined as values obtained on Day 1. Low-density lipoprotein cholesterol (LDL-C) was measured in millimoles per liter (mmol/L) and obtained through local laboratories.|Baseline to Week 16|Full Analysis Set (FAS) consisted of participants who were enrolled, took at least 1 study medication and had at least 1 post baseline HbA1c assessment. For this outcome measure, 1, 3, and 9 normal, overweight, obese participants, respectively, were missing and were not included in the analysis.||mmol/L||95% Confidence Interval|Mean
790816|NCT00883090|Secondary|Adverse Events|Number of participants with an adverse event|16 weeks|The analysis population was the safety population. The safety population comprised all subjects who received a dose of Factor XIII.||participants|||Number
778502|NCT00778622|Secondary|Mean Change From Baseline at Week 16 (95% Confidence Interval) in Fasting Total Cholesterol (TC) - Full Analysis Set|For fasting total cholesterol (TC), baseline is defined as Day 1 (first day of treatment). Total cholesterol was measured in millimoles per liter (mmol/L) and obtained through local laboratories.|Baseline to Week 16|Full Analysis Set (FAS) consisted of participants who were enrolled, took at least 1 study medication and had at least 1 post baseline HbA1c assessment. For this outcome measure, 1, 3, and 8 normal, overweight, obese participants, respectively, were missing and were not included in the analysis.||mmol/L||95% Confidence Interval|Mean
778503|NCT00778622|Secondary|Mean Change From Baseline at Week 16 (95% Confidence Interval) of Fasting Plasma Glucose (FPG) - Full Analysis Set|Baseline was defined as the value obtained at the screening visit. FPG was measured in millimoles/Liter (mmol/L) and obtained through local laboratories.|Baseline to Week 16|Full Analysis Set (FAS) included enrolled participants,who took at least 1 dose of drug and had at least 1 post baseline HbA1c assessment. For this outcome measure, 1, 1, and 1 normal, overweight, obese participants, respectively, were missing and were not included in the analysis.||mmol/L||95% Confidence Interval|Mean
778504|NCT00778622|Primary|Mean Change From Baseline at Week 16 (95% Confidence Interval) in Glycosated Hemoglobin A1c (HbA1c) (Last Observation Carried Forward) - Full Analysis Set (FAS)|Baseline for HbA1c is defined as that value obtained at screening visit. HbA1c was measured as a percent (%) of hemoglobin; normal range was 4.7 to 6.4% and values were obtained through a central laboratory. The Last Observation Carried Forward (LOCF) data set includes data recorded at a given visit or, if no observation is recorded at that visit, data carried forward from the previous visit.|Baseline to Week 16|Full Analysis Set included participants who were enrolled, took at least 1 study medication and had at least 1 post baseline HbA1c assessment. Baseline data was not carried forward or averaged with on-treatment data to impute missing values for the LOCF data set.||percentage of hemoglobin||95% Confidence Interval|Mean
778505|NCT00778648|Secondary|Secondary Endpoints of This Study Are Mean Health-related Quality of Life, Mean Common Cold Related Total Costs, Direct and Indirect (Productivity Loss) Costs||Baseline, months 2,4,6,8.||||||
778506|NCT00778648|Primary|Number of Days With at Least Moderate (i.e. Moderate or Severe) Common Cold Symptoms.||within 6 months (after 2 months run-in period)|||Number of days||95% Confidence Interval|Mean
778507|NCT00780572|Primary|Time to Intervention Once an ADE Alert Has Fired in CPRS||From the time an ADE alert fires in CPRS until the time action has been taken, i.e. an order placed, up to 24 hours.|||hours to intervention||Inter-Quartile Range|Median
778508|NCT00780676|Primary|Clinical Benefit (CB) Rate (CB = Participants With Objective Tumor Response or Stable Disease > 6 Months)|Rate of participants with response complete, partial response or stable disease categorized by Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. Radiological response assessments must be repeated every 8 weeks during therapy.|Tumor status assessed every 8 weeks during therapy, up to 6 months|Selumetinib pathway predictor groups (both MEK pathway activity predictor positive and MEK pathway predictor negative) had no patients assigned to either group, and only treated participants (30) included in analysis.||Percentage of Participants|||Number
778509|NCT00780741|Secondary|Proportion of Participants With Office Probing Success 6 Months After Randomization|The proportion of immediate office group participants whose office probing was successful when assessed 6 months after randomization. Office probing success was defined as absence of three clinical signs of NLDO (epiphora, increased tear lake, and mucous discharge) 6 months after randomization and no reoperation.|Randomization to 6 months|Participants randomized to immediate office probing who underwent office probing.||proportion with treatment success||95% Confidence Interval|Number
778510|NCT00780741|Secondary|Proportion of Deferred Facility Probing Group Participants With 6-Month Resolution of NLDO Without Surgery|Absence of three clinical signs of NLDO (epiphora, increased tear lake, and mucous discharge) upon unmasked examination 6 months after randomization. Participants who were operated before the 6-month visit were considered treatment failures.|Randomization to 6 months|All participants who had unilateral nasolacrimal duct obstruction at baseline, who were randomized to the deferred facility probing group, and who completed the 6-month visit (timed from randomization). The analysis followed the intent to treat principle.||proportion of participants||95% Confidence Interval|Number
778511|NCT00780741|Secondary|Months of Symptoms of Nasolacrimal Duct Obstruction (NLDO) Between Randomization and 18 Months of Age|Months of NLDO symptoms between randomization and 18 months of age. When resolution of NLDO occurred without surgery, the time of resolution was estimated as the midpoint between randomization and the first time point at which symptoms/signs were reported as absent (i.e. 3-month phone call, 6-month visit, or 18 months of age visit) without a subsequent report of symptoms/signs. For patients who underwent successful surgery, months of symptoms was estimated as months between randomization and the surgery. Patients who had clinical signs present at the 18 month of age visit were considered to have had symptoms present since randomization.|Randomization to 18 months of age.|All participants who had unilateral nasolacrimal duct obstruction at baseline and who completed the visit at 18 months of age were analyzed. The analysis followed the intent to treat principle.||months of symptoms||Full Range|Mean
778512|NCT00780741|Primary|Cost of Treatment|Total cost of treatment including the cost of an initial office consultation and all surgeries received (i.e. initial surgeries and reoperations) and medications prescribed for NLDO between randomization and the 18 months of age visit. Estimates of treatment costs were obtained primarily from the 2011 Medicare Fee Schedules.|Randomization to 18 months of age|All participants who had unilateral nasolacrimal duct obstruction at baseline and who completed the visit at 18 months of age were analyzed. The analysis followed the intent to treat principle.||US dollars||Full Range|Mean
778513|NCT00780741|Primary|Proportion of Participants With Treatment Success|Absence of three clinical signs of NLDO (epiphora, increased tear lake, and mucous discharge) upon masked examination at 18 months of age.|18 months of age|All participants who had unilateral nasolacrimal duct obstruction at baseline and who completed the primary outcome visit at 18 months of age were analyzed. The analysis followed the intent-to-treat principle.||proportion of participants|||Number
778515|NCT00781079|Secondary|Quality of Life Interview, Brief Version|Subjective ratings of overall quality of life and the quality of social relationships, daily life, and family interactions was assessed using a combination of selected scales from the Quality of Life Instrument-Brief Version (QOLI), which been used extensively with a wide range of populations including those who are homeless, have a dual diagnosis, and are ethnic minorities. Because of low internal consistencies of subscales in our sample, a factor analysis was conducted which indicated that a larger scale that included the items from the overall quality of life, social relationships, daily life, and family interactions scales would be more reliable.|immediately before the intervention (BL), and 12 months post intervention (Post).||||||
778516|NCT00781079|Secondary|Illness Management and Recovery Scale: Client Self-Rating||12 months prior to the intervention (BL1), immediately before the intervention (BL2), and 12 months post intervention (Post).||||||
778517|NCT00781079|Secondary|Recovery Self-Assessment: Person in Recovery Version|Perceptions of the recovery orientation of the program were assessed with the Recovery Self-Assessment (RSA), a 36 item survey that assesses domains of recovery-orientated practice (e.g., focus on life goals, involvement of patients in their own care). The RSA has high internal consistency and is thought to represent a more recovery-oriented or recovery-supportive environment.|immediately before the intervention (BL), and 12 months post intervention (Post)||||||
778518|NCT00781079|Secondary|Patient Activation Measure|The mental health version of the Patient Activation Measure (PAM) is a single 13-item scale designed to assess patient’s knowledge, skill, and confidence in health self-management. Respondents endorse items (e.g., “I know what each of my prescribed medications do”) on a scale from 1 (“disagree strongly”) to 4 (“agree strongly”). Raw scores are converted using the established methodology for the PAM to an activation score from 0 (lowest)-100 (highest). Identifying levels of activation is based on whether an activation score falls within a previously determined range of scores. Level 1, the lowest level of activation, includes activation scores of 47 or lower; Level 2 includes scores of 47.1 to 55.1; Level 3 includes scores of 55.2 to 67.0; and Level 4 (the highest activation level) includes scores of 67.1 or above. This version has similar psychometric properties as the original 13-item PAM and correlates with related constructs in other samples of people with SMI.|immediately before the intervention (BL), and 12 months post intervention (Post).|||units on a scale||Standard Deviation|Mean
778519|NCT00781079|Secondary|Mental Health Recovery Measure (MHRM)|The Mental Health Recovery Measure (MHRM) is a 30-item, 5-point behaviorally-anchored self-report measure based upon recovery experiences of persons with psychiatric disabilities. The MHRM total score has good validity, correlating strongly with the Empowerment Scale and Community Living Skills Scales, yet assessing unique aspects of recovery.|immediately before the intervention (BL), and 12 months post intervention (Post).||||||
778520|NCT00781079|Primary|BASIS-R|The BASIS-R is a 24 item, comprehensive instrument assessing a range of psychiatric symptoms and problems. It is valid and reliable in both inpatient and outpatient settings in populations with SMI. All items have five response options ranging from 0 to 4, with higher scores indicating more problems (range in possible scores is 0 to 96).|immediately before the intervention (BL), and 12 months post intervention (Post).|||units on a scale||Standard Deviation|Mean
778521|NCT00781274|Primary|The Percentage of Subjects Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)||After 24 weeks of follow-up|||percentage of subjects achieving SVR||95% Confidence Interval|Number
778522|NCT00781326|Primary|Hamilton Depression Rating Scale (24 Item) [Phase I Primary Outcome]|Hamilton Depression Rating Scale (24 item) measures symptoms of major depression. We report total score which is the sum of all items. Total score range is 0 to 76 with higher scores indicating more severe depression. We reports scores at end of Phase I for subjects completing the phase.|End of Phase I (at 24 weeks)|||units on a scale||Standard Deviation|Mean
778523|NCT00781365|Primary|Mean Diastolic Blood Pressure|Mean diastolic blood pressure at baseline and 4 time points|Baseline, 6 months, 12 months, 18 months, 54 months|||mm Hg||95% Confidence Interval|Mean
778524|NCT00781365|Primary|Mean Systolic Blood Pressure|Systolic blood pressure at baseline and 4 time points|Baseline, 6 months, 12 months, 18 months, 54 months|||mmHg||95% Confidence Interval|Mean
778525|NCT00781365|Primary|Blood Pressure Control|Percentage of patients with controlled blood pressure at each time point (less than 140/90 mmHg or 130/80 mmHg for patients with kidney disease or diabetes)|Baseline, 6 months, 12 months, 18 months|||percentage of participants||95% Confidence Interval|Number
778526|NCT00781391|Secondary|Adjudicated Bleeding Events|"Compare edoxaban versus warfarin for Adjudicated Bleeding Events during the on-treatment period in the Safety Analysis set.
Major bleeding was adjudicated by the Clinical Events Committee (CEC) and defined based on published guidance from the International Society on Thrombosis and Haemostasis (ISTH), with minor modifications for Hgb decrease and blood transfusion requirements."|on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up|Safety-analysis set, on-treatment period||number of participants with event|||Number
778527|NCT00781391|Secondary|Compare Edoxaban to Warfarin for Composite of Stroke, SEE, and All-cause Mortality|Compare Edoxaban to warfarin for Composite of stroke, Systemic Embolic Events, and all-cause mortality during the overall study period in the ITT analysis set.|overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up|ITT overall study period, which included all randomized subjects whether or not they received a single dose of randomized study drug. The time frame included from the reference date (randomization date) to the common study end date (CSED) Visit.||number of participants with event|||Number
778528|NCT00781391|Secondary|Compare Edoxaban to Warfarin for Major Adverse Cardiac Event (MACE): a Composite of Non-fatal MI, Non-fatal Stroke, Non-fatal SEE, and Death Due to CV Cause or Bleeding|Compare edoxaban to warfarin for Major Adverse Cardiac Event (MACE): a composite of non-fatal Myocardial Infarction, non-fatal stroke, non-fatal Systemic Embolic Events, and death due to Cardiovascular cause or bleeding during the overall study period in the ITT analysis set.|overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up|ITT overall study period, which included all randomized subjects whether or not they received a single dose of randomized study drug. The time frame included from the reference date (randomization date) to the common study end date (CSED) Visit.||number of participants with event|||Number
791387|NCT00885482|Primary|Number of Patients With Virological Failure (Two Consecutive Measures of HIV-RNA Higher Than 50 Copies/mL or a Single Measure Higher Than 1000 Copies/mL) Within 48 Weeks at intention-to.Treat Analysis||48 weeks|||patients|||Number
778529|NCT00781391|Secondary|Compare Edoxaban to Warfarin for Composite of Stroke, Systemic Embolic Event (SEE), and Cardiovascular (CV) Mortality|Compare edoxaban to warfarin for the composite of stroke, Systemic Embolic Events, and Cardiovascular mortality during the overall study period in the ITT analysis set.|overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up|ITT (Intent To Treat) Analysis set; overall study period, which included all randomized subjects whether or not they received a single dose of randomized study drug. The time frame included from reference date (randomization date) to the common study end date (CSED) Visit..||number of participants with event|||Number
778530|NCT00781391|Primary|Compare Edoxaban to Warfarin for Superiority for Composite of Stroke and Systemic Embolic Events (SEE).|Compare edoxaban to warfarin for the composite of stroke and Systemic Embolic Events (SEE) during the overall study period in the ITT analysis set with a superiority analysis.|overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up|ITT (Intent To Treat) Analysis set; which included all randomized subjects whether or not they received a single dose of randomized study drug. The time frame included from reference date (randomization date) to the common study end date (CSED) Visit.||number of participants with event|||Number
778531|NCT00781391|Primary|Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE).|The composite of stroke and Systemic Embolic Events (SEE) during the overall study period in the PP (per protocol) analysis set population.|overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up|PP (per Protocol) Analysis set; which included all randomized subjects who received 1 or more dose of study drug for the overall study period (first dose to end of study) and did not have any major protocol violations. The time period included from the reference date (initial dose of study drug date) to the common study end date (CSED) Visit.||number of participants with event|||Number
778532|NCT00781391|Primary|Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE).|The composite of stroke and Systemic Embolic Events (SEE) during the on treatment period in the PP (per protocol) analysis set population.|on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up|PP (Per Protocol) Analysis set; which included all randomized subjects who received at least 1 dose of randomized study drug and did not have any major protocol violations. The time period included the time the subject was taking study drug and up to 3 days after their last dose (On Treatment Period).||number of participants with event|||Number
778533|NCT00781391|Primary|Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE).|The composite of stroke and Systemic Embolic Events (SEE) during the overall study period in the mITT analysis population.|overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up|mITT (modified Intent To Treat) Analysis set; which included randomized subjects who received 1 or more dose of study drug. The time frame included overall study period (first dose to end of study).||Number of participants with event|||Number
778534|NCT00781391|Primary|Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE).|The composite of stroke and Systemic Embolic Events (SEE) during the on treatment period in the mITT analysis population with a non-inferiority analysis.|on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up|mITT (modified Intent To Treat) Analysis set; which included randomized subjects who received 1 or more dose of study drug. The time period included the subject was taking study drug and up to 3 days after their last dose (On-Treatment ).||number of participants with event|||Number
778535|NCT00781456|Secondary|Mean Number of Days of Bleeding or Spotting|Bleeding and spotting were recorded by participants in the migraine diary during the 91-day treatment period.|91-day treatment period|Safety population with available data||days||Standard Deviation|Mean
778536|NCT00781456|Secondary|Number of Participants With Adverse Events (AEs)|"An AE is any untoward medical occurrence in a clinical investigation participant and which does not necessarily have to have a causal relationship with this treatment or clinical study.
The following definitions were used to assess AE severity: Mild: Awareness of signs or symptoms, but they are easily tolerated; Moderate: Enough discomfort to cause interference with usual activity; Severe: Incapacitating, with inability to perform usual activity.
Relationship to study drug was assessed as either: None: Causal relationship can be ruled out; Possibly: Causal relationship at least reasonably possible, i.e. relationship cannot be ruled out; Definitely: Causal relationship is certain.
A serious adverse event (SAE) is one that met any one of the following criteria:
Fatal or life threatening
Requires or prolongs in patient hospitalization
Results in persistent or significant disability/incapacity
Congenital anomaly / birth defect
Important medical event."|Up to 15 weeks|Safety population, consisting of all participants who received at least one dose of study drug.||participants|||Number
778537|NCT00781456|Secondary|Change From Baseline in Headache Impact Test|"The Headache Impact Test (HIT) is a tool used to measure the impact headaches have on patients' ability to function on the job, at school, at home and in social situations.
HIT-6 consists of 6 questions each scored on a scale from Never (6 points) to Always (13 points). The total score ranges from 36 to 78 with higher scores indicating greater impact on life.
There was an error in administration of the HIT-6 in this study. Question 6 was not administered, and question 3 from the MIDAS was included instead. Therefore, the total score of the HIT-6 could not be calculated."|Baseline and Week 15|Analysis was not performed due to an error in the administration of the test.|||||
778538|NCT00781456|Secondary|Change From Baseline in Migraine Disability Assessment|"The migraine disability assessment (MIDAS) test is used to determine how severely migraines affect a patient's life. Participants were asked five questions about how often their headaches limited their ability to go to work or school, to do household work or to do family or leisure activities in the past 3 months.
The MIDAS score equals the sum of the days answered for each question and ranges from 0 (no disability) to approximately 270 (severe disability; the upper bound is dependent on the number of days a participant would plan to work or participate in other activities).
The MIDAS score is classified into four grades of severity:
0 to 5: MIDAS Grade I, Little or no disability
6 to 10: MIDAS Grade II, Mild disability
11 to 20: MIDAS Grade III, Moderate disability
21+: MIDAS Grade IV, Severe disability"|Baseline and Week 15|Intent-to-treat population with available data.||units on a scale||Standard Deviation|Mean
778539|NCT00781456|Secondary|Percentage of Participants Who Required Rescue Medications During the Study Period|Participants recorded use of rescue medications for migraines in the migraine diary during the course of study treatment.|Baseline, Month 1, Month 2 and Month 3|Intent-to-treat population with available data. N indicates the number of participants with available data at each time period.||percentage of participants|||Number
778540|NCT00781456|Secondary|Change From Baseline in Average Migraine Severity|"Migraine severity was recorded by participants in the Baseline qualification diary and study migraine diary during the treatment period. Participants could report a severity of none (score = 0), mild (1), moderate (2), or severe (3). In general, if a headache was mild, daily activities could be resumed and little to no medication was taken. Moderate headaches required medication and effected daily activities. Severe headaches were debilitating and required medication.
Average migraine severity is defined as the sum of the severity ratings divided by the total number of migraine episodes reported during the observation period (for example, Baseline, First Month, Second Month, Third Month, and 91-Day Treatment Period). A negative change from Baseline score indicates improvement in severity."|Baseline and Month 1, Month 2 and Month 3|Intent-to-treat population with available data. N indicates the number of participants with available data at each time period.||units on a scale||Standard Error|Least Squares Mean
778541|NCT00781456|Secondary|Percentage of Participants With ≥ 50% Reduction in Migraine Frequency During the First, Second and Third Months|The percentage of participants with at least 50% reduction in migraine frequency (average weekly number of migraine episodes) compared to Baseline at each month of the treatment period.|Baseline, Month1, Month 2 and Month 3|Intent-to-treat population with available data. N indicates the number of participants with available data at each time point.||percentage of participants|||Number
778542|NCT00781456|Primary|Percentage of Participants With ≥ 50% Reduction in Migraine Frequency During the Treatment Period|The number of participants with at least 50% reduction in migraine frequency (average weekly number of migraine episodes) through the end of the 91-day treatment period compared with Baseline (the 25- to 35-day baseline qualification period). Participants recorded the incidence, timing and intensity of migraines in a migraine diary during the prequalification period and throughout the 91-day treatment period.|Baseline (25-35 days before Day 1) and Days 1-91|Intent-to-treat population||percentage of participants|||Number
778543|NCT00781508|Secondary|The Distance Walked During the 6-minute Walk Test 1 hr After the Oral Administration of Sildenafil 50 mg.|A standardized course was used to determine the distance walked (meters) during a 6 min walk supervised by a nurse trained in performance of the test.|Measured 1 hr after oral administration of sildenafil 50 mg|||meters||Standard Deviation|Mean
778544|NCT00781508|Primary|Reduction of the Left Ventricular Filling Pressure in Association With Administration of Sildenafil|Left ventricular filling pressure was assessed by the ratio of the velocity of early mitral inflow (E) divided by the early tissue velocity (e). E/e|Left ventricular filling pressure was assessed 1 hr after oral administration of sildenafil|All patients (10) that completed the protocol were analyzed.||E/e' ratio||Standard Deviation|Mean
778545|NCT00781599|Secondary|Carbon Monoxide-verified Abstinence|Carbon monoxide-verified abstinence determined as a measure of <10 ppm (parts per million). Less than 2ppm CO found in healthy non-smokers.|Month 2|A total of 57 participants completed the month 2 visit. The 15 participants lost to follow-up were treated as smokers for the purposes of data analysis.||participants|||Number
778546|NCT00781599|Secondary|Carbon Monoxide-verified Abstinence|Carbon monoxide-verified abstinence determined as a measure of <10 ppm (parts per million). Less than 2ppm CO found in healthy non-smokers.|Month 1|A total of 60 participants completed the month 1 visit. The 12 participants lost to follow-up were treated as smokers for the purposes of data analysis.||participants|||Number
778547|NCT00781599|Secondary|Cotinine Verified 7 Day Point Prevalence Smoking Abstinence|Smoking cessation verified by salivary cotinine (COT). A COT of <20 ng/ml indicated smoking abstinence.|Month 3|A total of 61 participants completed the final month 3 visit. The 11 participants lost to follow-up were treated as smokers for the purposes of data analysis.||participants|||Number
778548|NCT00781599|Primary|Percent Compliance With Chantix|Compliance with Chantix calculated as the total doses taken over the total number of doses prescribed. Adherence was measured by pill counts. Measurements taken during monthly medication refill visits. There was no specific predetermined cutoff number on the scale which determined non-compliance. All results from compliance calculations are included in the table.|Months 1, 2, 3|Number of participants determined by total number of enrolled participants. For reporting purposes, those participants that did not show up for a visit were treated as smokers.||Percentage of Participants||Standard Deviation|Mean
778549|NCT00781859|Secondary|Proportion of Subjects With Total Posterior Vitreous Detachment (PVD) at Day 28|The key secondary endpoint of this study was the proportion of subjects with total Posterior Vitreous Detachment (PVD) at Day 28, as determined by masked Investigator assessment of B-scan ultrasound.|Day 28|Intention-To-Treat (ITT, Last Observation Carried Forward (LOCF)||percentage of participants|||Number
778550|NCT00781859|Primary|Proportion of Subjects With Nonsurgical Resolution of Focal Vitreomacular Adhesion at Day 28.|The primary efficacy endpoint was the proportion of subjects with nonsurgical resolution of focal vitreomacular adhesion at Day 28 post-injection, as determined by masked Central Reading Center (CRC) Optical Coherence Tomography (OCT) evaluation. Any subjects who had a creation of an anatomical defect (i.e. retinal hole, retinal detachment) that resulted in loss of vision or that required additional intervention were not counted as successes for this primary endpoint.|Day 28|Intention-To-Treat (ITT), Last Observation Carried forward (LOCF)||percentage of participants|||Number
780229|NCT00794118|Primary|Physician Global Assessment (PGA) of Disease Activity at Month 6|PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible.|Month 6|ITT population included all participants who received at least 1 dose of the study medication.||cm||Standard Deviation|Mean
778577|NCT00781950|Secondary|Effects on Exercise Performance, Blood Pressure and Circulating Lipid Levels.||1 year|||mmHg||Standard Error|Mean
778578|NCT00781950|Primary|Number of Participants With All-cause Mortality, Cardiovascular Mortality, Stroke, and Myocardial Infarctions||1 year|||participants|||Number
778579|NCT00781963|Primary|Pittsburgh Sleep Quality Index (PSQI)|The Pittsburgh Sleep Quality Index assesses subjective sleep quality and sleep disturbances The PSQI ia an 18-item questionnaire with a total score range from 0 – 21. A total score > 8 indicates poor sleep quality.|Six months after baseline assessment|||units on a scale||Standard Deviation|Mean
778580|NCT00781963|Primary|Sleep Efficiency|Calculated from 7-day sleep diary|Six months after baseline assessment||||||
778581|NCT00782067|Secondary|Overall Survival (OS)||5 years||||||
778582|NCT00782067|Secondary|Time to Response||5 years||||||
778583|NCT00782067|Secondary|Duration of Response||5 years||||||
778584|NCT00782067|Primary|Overall Response Rate (ORR)|The ORR was defined as the percentage of participants who classified as confirmed responders (major response (MR) or partial response (PR). A major responder had complete resolution of at least one C-Finding and no progression in other C-Findings. A partial responder showed a measurable improvement in one or more C-Finding(s) without confirmed progression in other C-Findings. A C-Finding was a Clinical Finding, which was considered by the investigator and corroborated by the Study Steering Committee (SSC) Chairperson or designee, attributable to the mast cell disease component and not the associated hematological clonal non-mast cell lineage disease (AHNMD) component or any other cause.|6 months|Primary Efficacy Population: participants assigned to study treatment who met diagnostic criteria for aggressive systemic mastocytosis or mast cell leukemia and presented with at least 1 measurable C-Finding at study entry and/or participants with transfusion dependent anemia due to their underlying disease at study entry as confirmed by the SCC.||Percentage of participants|||Number
778585|NCT00782171|Secondary|Nature and Frequency of Adverse Events (AEs) - Number of Adverse Events|Number of Adverse Events Number of related/unknown AE Number of related/unknown SAEs Number of Serious Adverse Events (SAEs)|until the 3 year post-surgery|All patients who had signed the informed consent form and received a study implant, regardless if all primary and secondary inclusion/exclusion criteria after Implantation were fulfilled||number of events|||Number
778586|NCT00782171|Secondary|Implant Success|Implant success: An implant was deemed to be successful if there was a lack of implant mobility, absence of any continuous peri-implant radiolucency based on radiographic findings, absence of any recurrent peri-implant infection, absence of continuous or recurrent pain and absence of structural failure of the implant|3 years post-surgery|||implants|Number of Implants||Number
778587|NCT00782171|Secondary|Implant Success|Implant success: An implant was deemed to be successful if there was a lack of implant mobility, absence of any continuous peri-implant radiolucency based on radiographic findings, absence of any recurrent peri-implant infection, absence of continuous or recurrent pain and absence of structural failure of the implant|2 years post-surgery|The analysis was based on implants as observational unit. The 2-year data was analyzed together with the 3-year data. Our statistical analysis for 2-year time point included how many implants were available but not how many participants.||implants|Number of Implants||Number
778588|NCT00782171|Secondary|Implant Success|Implant success: An implant was deemed to be successful if there was a lack of implant mobility, absence of any continuous peri-implant radiolucency based on radiographic findings, absence of any recurrent peri-implant infection, absence of continuous or recurrent pain and absence of structural failure of the implant|1 years post-surgery|||implants|Number of Implants||Number
778589|NCT00782171|Secondary|Implant Success|Implant success: An implant was deemed to be successful if there was a lack of implant mobility, absence of any continuous peri-implant radiolucency based on radiographic findings, absence of any recurrent peri-implant infection, absence of continuous or recurrent pain and absence of structural failure of the implant|20-23 weeks post-surgery|||implants|Number of Implants||Number
778590|NCT00782171|Secondary|Nature and Frequency of Adverse Events (AEs) - Number of Patients Affected|Patients affected by AE Patients affected by related/ unknown AE|until the 3 year post-surgery|All patients who had signed the informed consent form and received a study implant, regardless if all primary and secondary inclusion/exclusion criteria after Implantation were fulfilled||patients affected|||Number
778591|NCT00782171|Secondary|Implant Survival|Implant survival: An implant was deemed to be surviving, if it was still in place at the time of Evaluation|3 years post-surgery|||implants|Number of Implants||Number
778592|NCT00782171|Secondary|Implant Survival|Implant survival: An implant was deemed to be surviving, if it was still in place at the time of Evaluation|2 years post-surgery|||implants|Number of Implants||Number
778595|NCT00782171|Primary|Evaluation of Changes in Crestal Bone Levels Evaluated From Standardized Periapical X-rays Comparing the Immediate and Delayed Loading Procedures in Each Group.||Change in crestal bone level from surgery (baseline) to 3 years post-surgery|This analysis was based on bone level measurements of implants as observational unit. The final number of units analyzed for the defined period is based on x-rays available at both time points (baseline and follow-up visit). Our statistical analysis of the study data included how many implants were analyzed but not how many participants.||mm|Implants|Standard Deviation|Mean
778596|NCT00782171|Primary|Evaluation of Changes in Crestal Bone Levels Evaluated From Standardized Periapical X-rays Comparing the Immediate and Delayed Loading Procedures in Each Group.||Change in crestal bone level from surgery (baseline) to 2 years post-surgery|This analysis was based on bone level measurements of implants as observational unit. The final number of units analyzed for the defined period is based on x-rays available at both time points (baseline and follow-up visit). Our statistical analysis of the study data included how many implants were analyzed but not how many participants.||mm|Implants|Standard Deviation|Mean
778597|NCT00782171|Primary|Evaluation of Changes in Crestal Bone Levels Evaluated From Standardized Periapical X-rays Comparing the Immediate and Delayed Loading Procedures in Each Group.||Change in crestal bone level from surgery (baseline) to 1 year post-surgery|This analysis was based on bone level measurements of implants as observational unit. The final number of units analyzed for the defined period is based on x-rays available at both time points (baseline and follow-up visit). Our statistical analysis of the study data included how many implants were analyzed but not how many participants.||mm|Implants|Standard Deviation|Mean
778598|NCT00782171|Primary|Evaluation of Changes in Crestal Bone Levels Evaluated From Standardized Periapical X-rays Comparing the Immediate and Delayed Loading Procedures in Each Group.||Change in crestal bone level from surgery (baseline) to 20-23 Weeks post-surgery|This analysis was based on bone level measurements of implants as observational unit. The final number of units analyzed for the defined period is based on x-rays available at both time points (baseline and follow-up visit). Our statistical analysis of the study data included how many implants were analyzed but not how many participants.||mm|Implants|Standard Deviation|Mean
778599|NCT00782184|Secondary|Percent Change From Baseline in High-sensitivity C-Reactive Protein (Hs-CRP)||Baseline (Treatment Day 1), Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6.||percent change from baseline||95% Confidence Interval|Least Squares Mean
778600|NCT00782184|Secondary|Percent Change From Baseline in Apolipoprotein B/A-1 Ratio||Baseline (Treatment Day 1), Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6.||percent change from baseline||95% Confidence Interval|Least Squares Mean
778601|NCT00782184|Secondary|Percent Change From Baseline in Apolipoprotein A-1||Baseline (Treatment Day 1), Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6.||percent change from baseline||95% Confidence Interval|Least Squares Mean
778602|NCT00782184|Secondary|Percent Change From Baseline in Apolipoprotein B||Baseline (Treatment Day 1), Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6.||percent change from baseline||95% Confidence Interval|Least Squares Mean
778603|NCT00782184|Secondary|Percent Change From Baseline in Non-HDL Cholesterol/HDL-Cholesterol Ratio||Baseline (Treatment Day 1), Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6.||percent change from baseline||95% Confidence Interval|Least Squares Mean
778604|NCT00782184|Secondary|Percent Change From Baseline in Total Cholesterol/HDL-Cholesterol Ratio||Baseline (Treatment Day 1), Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6.||percent change from baseline||95% Confidence Interval|Least Squares Mean
778605|NCT00782184|Secondary|Percent Change From Baseline in LDL-Cholesterol/HDL-Cholesterol Ratio||Baseline (Treatment Day 1), Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6.||percent change from baseline||95% Confidence Interval|Least Squares Mean
778606|NCT00782184|Secondary|Percent Change From Baseline in Non-HDL Cholesterol||Baseline (Treatment Day 1), Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6.||percent change from baseline||95% Confidence Interval|Least Squares Mean
778607|NCT00782184|Secondary|Percent Change From Baseline in High-Density Lipoprotein (HDL) Cholesterol||Baseline (Treatment Day 1), Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6.||percent change from baseline||95% Confidence Interval|Least Squares Mean
778608|NCT00782184|Secondary|Percent Change From Baseline in Triglycerides||Baseline (Treatment Day 1), Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6.||percent change from baseline||95% Confidence Interval|Least Squares Mean
778609|NCT00782184|Secondary|Percent Change From Baseline in Total Cholesterol||Baseline (Treatment Day 1), Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6.||percent change from baseline||95% Confidence Interval|Least Squares Mean
778610|NCT00782184|Secondary|Number of Participants Reaching LDL-C Target Goal <100 mg/dL|Target LDL-C level of < 100 mg/dL (2.59 mmol/L) at study endpoint after 6 weeks of treatment for the Full Analysis Set (FAS) population.|Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with baseline and post-baseline data available.||participants|||Number
778611|NCT00782184|Secondary|Number of Participants Reaching LDL-C Target Goal <77 mg/dL|Target LDL-C level of < 77 mg/dL (2.00 mmol/L) at study endpoint after 6 weeks of treatment for the Full Analysis Set (FAS) population.|Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with baseline and post-baseline data available.||participants|||Number
778612|NCT00782184|Primary|Percent Change From Baseline in Low Density Lipoprotein (LDL)-C||Baseline (Treatment Day 1), Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6.||percent change from baseline||95% Confidence Interval|Least Squares Mean
778613|NCT00782184|Secondary|Number of Participants Reaching LDL-C Target Goals of <70 mg/dL|Target LDL-C level of < 70 mg/dL (1.81 mmol/L) at study endpoint after 6 weeks of treatment for the Full Analysis Set (FAS) population.|Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with baseline and post-baseline data available.||participants|||Number
778614|NCT00782210|Secondary|Change From Baseline in Potassium|Laboratory testing: Average change from baseline of potassium measured. The laboratory tests at Day 1 were considered the baseline measurements.|Day 1 and at 12, 24 and 48 weeks|Treated set.||mmol/L||Standard Deviation|Mean
778615|NCT00782210|Secondary|Changes in Safety Parameters Related to Treatment|Occurrence of bronchoconstriction, cardiac disorders and investigations related to treatment. Bronchoconstriction is defined as any of the following events: Drop in trough FEV1 >= 15%, Rescue medication use within 30 min of inhaling randomized treatment on a clinic test day or Cough, wheeze, or dyspnoea AE within 30 min of inhaling randomized treatment on a clinic test day.|48 weeks|Treated set.||percentage of participants|||Number
778616|NCT00782210|Secondary|Number of Moderate Chronic Obstructive Pulmonary Disease (COPD) Exacerbations|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations did not lead to hospitalization but included treatment with antibiotics and/or systemic steroids.|Baseline to end of study at 48 weeks.|||Number of COPD exacerbations||Standard Error|Mean
778617|NCT00782210|Secondary|Number of COPD Exacerbations Requiring Hospitalization|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations required hospitalization.|Baseline to end of study at week 48 visit|Treated set- all patients who received at least one dose of study medication||Number of COPD exacerbations||Standard Error|Mean
778618|NCT00782210|Secondary|Number of COPD Exacerbations|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria.|Baseline to end of study at week 48 visit|Treated set- all patients who received at least one dose of study medication||Number of COPD exacerbations||Standard Error|Mean
778619|NCT00782210|Secondary|Time to First Moderate Chronic Obstructive Pulmonary Disease (COPD) Exacerbation|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations did not lead to hospitalization but included treatment with antibiotics and/or systemic steroids. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor. Due to the limited number of events some statistics were not able to be calculated and are listed as N/A or are blank. The measure type is the First Quartile.|Baseline to end of study at 48 weeks.|Treated set- all patients who received at least one dose of study medication||days||95% Confidence Interval|Mean
778620|NCT00782210|Secondary|Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Leading to Hospitalization|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations required hospitalization. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor. Due to the limited number of events some statistics were not able to be calculated and are listed as N/A or are blank. The measure type is the First Quartile.|Baseline to end of study at 48 weeks.|Treated set- all patients who received at least one dose of study medication||days||95% Confidence Interval|Mean
778621|NCT00782210|Secondary|Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor. Due to the limited number of events some statistics were not able to be calculated and are listed as N/A or are blank. The measure type is the First Quartile.|Baseline to end of study at 48 weeks.|Treated set- all patients who received at least one dose of study medication||days||95% Confidence Interval|Mean
778622|NCT00782210|Secondary|Patient's Global Rating at Week 48|Patients were asked to rate their respiratory condition relative to their condition prior to the first dose of study medication. The scale is a seven point scale: 1=very much better, 2=much better,3=a little better,4=no change,5=a little worse,6=much worse,7=very much worst.|Week 48 visit|FAS||Point on scale||Standard Error|Mean
778623|NCT00782210|Secondary|Patient's Global Rating at Week 24|Patients were asked to rate their respiratory condition relative to their condition prior to the first dose of study medication. The scale is a seven point scale: 1=very much better, 2=much better,3=a little better,4=no change,5=a little worse,6=much worse,7=very much worst.|Week 24 visit|FAS||Point on scale||Standard Error|Mean
778624|NCT00782210|Secondary|Patient's Global Rating at Week 12|Patients were asked to rate their respiratory condition relative to their condition prior to the first dose of study medication. The scale is a seven point scale: 1=very much better, 2=much better,3=a little better,4=no change,5=a little worse,6=much worse,7=very much worst.|Week 12 visit|FAS||Point on scale||Standard Error|Mean
778625|NCT00782210|Secondary|Patient's Global Rating at Week 6|Patients were asked to rate their respiratory condition relative to their condition prior to the first dose of study medication. The scale is a seven point scale: 1=very much better, 2=much better,3=a little better,4=no change,5=a little worse,6=much worse,7=very much worst.|Week 6 visit|FAS||Point on scale||Standard Error|Mean
778629|NCT00782210|Secondary|Weekly Mean Evening Peak Expiratory Flow Rate (PEF)|Weekly mean evening peak expiratory flow rate (PEF) at 48 weeks. PEFR measurements recorded by means of an e-Diary on a daily basis. This e-Diary was used to record the twice daily PEFs, study drug use, and rescue salbutamol (albuterol) use. The best of three readings for each measurement was recorded.|at bedtime from Screening to week 48|FAS||L/min||Standard Error|Mean
778630|NCT00782210|Secondary|Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEF)|Weekly mean pre-dose morning peak expiratory flow rate (PEF) at 48 weeks. PEFR measurements recorded by means of an e-Diary on a daily basis. This e-Diary was used to record the twice daily PEFs, study drug use, and rescue salbutamol (albuterol) use. The best of three readings for each measurement was recorded.|immediately upon arising (before drug administration) from Screening to week 48|FAS||L/min||Standard Error|Mean
778631|NCT00782210|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-12 h (AUC 0-12h) Response at Day 85 (12 Weeks)|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a non-mixed effects model with treatment (trt), tio stratum, baseline as fixed effects. FVC AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and -1h and -10 min, 5 min, 15 min, 30 min, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h relative to dose at Day 85 (12 weeks)|Patients in FAS with spirometry data after 3 hours at Visit 5 (12-hour pulmonary function test set)||Liter||Standard Error|Mean
778632|NCT00782210|Secondary|FVC Peak (0-3h) Response After 48 Weeks|Response was defined as change from baseline. Baseline FVC peak (0-3h) was defined as the mean of the available pre-dose FVC peak (0-3h) values prior to first dose of randomized treatment. FVC Peak (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks|FAS||Liter||Standard Error|Mean
778633|NCT00782210|Secondary|FVC Peak (0-3h) Response After 24 Weeks|Response was defined as change from baseline. Baseline FVC peak (0-3h) was defined as the mean of the available pre-dose FVC peak (0-3h) values prior to first dose of randomized treatment. FVC Peak (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks|FAS||Liter||Standard Error|Mean
778634|NCT00782210|Secondary|FVC Peak (0-3h) Response After 12 Weeks|Response was defined as change from baseline. Baseline FVC peak (0-3h) was defined as the mean of the available pre-dose FVC peak (0-3h) values prior to first dose of randomized treatment. FVC Peak (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 12 weeks|FAS||Liter||Standard Error|Mean
778635|NCT00782210|Secondary|FVC Peak (0-3h) Response After 6 Weeks|Response was defined as change from baseline. Baseline FVC peak (0-3h) was defined as the mean of the available pre-dose FVC peak (0-3h) values prior to first dose of randomized treatment. FVC Peak (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks|FAS||Liter||Standard Error|Mean
778636|NCT00782210|Secondary|FVC Peak (0-3h) Response After 2 Weeks|Response was defined as change from baseline. Baseline FVC peak (0-3h) was defined as the mean of the available pre-dose FVC peak (0-3h) values prior to first dose of randomized treatment. FVC Peak (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|FAS||Liter||Standard Error|Mean
778637|NCT00782210|Secondary|FVC Peak (0-3h) Response At Day 1|Response was defined as change from baseline. Baseline FVC peak (0-3h) was defined as the mean of the available pre-dose FVC peak (0-3h) values prior to first dose of randomized treatment. FVC Peak (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose at Day 1|FAS||Liter||Standard Error|Mean
778638|NCT00782210|Secondary|Trough FVC Response After 48 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 48 weeks|FAS||Liter||Standard Error|Mean
778688|NCT00782340|Secondary|Patient-Reported Clinical Global Improvement - Severity Scores|"The CGI-S is a 7 point scale ranging from a score of 1 (no symptoms) to 7 (severe symptoms). Patients were grouped according to OH severity at the end of the randomization period as follows;
Normal-Borderline OH (CGI-S 1-2), Mild-Moderate OH (CGI-S 3-4), Marked OH-Most Ill with OH (CGI-S 5-7)."|7 days|||participants|||Number
778639|NCT00782210|Secondary|Trough FVC Response After 40 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 40 weeks|FAS||Liter||Standard Error|Mean
778640|NCT00782210|Secondary|Trough FVC Response After 32 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 32 weeks|FAS||Liter||Standard Error|Mean
778641|NCT00782210|Secondary|Trough FVC Response After 24 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 24 weeks|FAS||Liter||Standard Error|Mean
778642|NCT00782210|Secondary|Trough FVC Response After 18 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 18 weeks|FAS||Liter||Standard Error|Mean
778643|NCT00782210|Secondary|Trough FVC Response After 12 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 12 weeks|FAS||Liter||Standard Error|Mean
778644|NCT00782210|Secondary|Trough FVC Response After 6 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 6 weeks|FAS||Liter||Standard Error|Mean
778645|NCT00782210|Secondary|Trough FVC Response After 2 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 2 weeks|FAS||Liter||Standard Error|Mean
778646|NCT00782210|Secondary|FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response After 48 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks|FAS||Liter||Standard Error|Mean
778647|NCT00782210|Secondary|FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response After 24 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks|FAS||Liter||Standard Error|Mean
791695|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Albumin)||Baseline up to Month 7|||percentage of participants|||Number
778648|NCT00782210|Secondary|FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response After 12 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 12 weeks|FAS||Liter||Standard Error|Mean
778649|NCT00782210|Secondary|FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response After 6 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks|FAS||Liter||Standard Error|Mean
778650|NCT00782210|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-3 Hours (AUC 0-3h) Response After 2 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|FAS||Liter||Standard Error|Mean
778651|NCT00782210|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-3 Hours (AUC 0-3h) Response At Day 1|Response was defined as change from baseline. Baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose at Day 1|FAS||Liter||Standard Error|Mean
778652|NCT00782210|Secondary|Peak FEV1 (0-3h) Response After 48 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks|FAS||Liter||Standard Error|Mean
778653|NCT00782210|Secondary|Peak FEV1 (0-3h) Response After 24 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks|FAS||Liter||Standard Error|Mean
778654|NCT00782210|Secondary|Peak FEV1 (0-3h) Response After 12 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 12 weeks|FAS||Liter||Standard Error|Mean
778655|NCT00782210|Secondary|Peak FEV1 (0-3h) Response After 6 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks|FAS||Liter||Standard Error|Mean
778656|NCT00782210|Secondary|Peak FEV1 (0-3h) Response After 2 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|FAS||Liter||Standard Error|Mean
778689|NCT00782340|Secondary|Change in Dizziness/ Lightheadedness/ Feeling Faint/ or Feeling Like You Might Blackout (OHSA Item 1)|OHSA item 1 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. A negative score indicates an improvement during the double-blind randomized phase relative to value at randomization.|7 days|Missing data are imputed using the last observation carried forward method.||units on a scale||Standard Deviation|Mean
778657|NCT00782210|Secondary|Peak FEV1 (0-3h) Response At Day 1|"Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment.
Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by- visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect."|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose at Day 1|FAS||Liter||Standard Error|Mean
778658|NCT00782210|Secondary|Trough FEV1 Response After 48 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 48 weeks|FAS||Liter||Standard Error|Mean
778659|NCT00782210|Secondary|Trough FEV1 Response After 40 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 40 weeks|FAS||Liter||Standard Error|Mean
778660|NCT00782210|Secondary|Trough FEV1 Response After 32 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 32 weeks|FAS||Liter||Standard Error|Mean
778661|NCT00782210|Secondary|Trough FEV1 Response After 24 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 24 weeks|FAS||Liter||Standard Error|Mean
778662|NCT00782210|Secondary|Trough FEV1 Response After 18 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 18 weeks|FAS||Liter||Standard Error|Mean
778663|NCT00782210|Secondary|Trough FEV1 Response After 6 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 6 weeks|FAS||Liter||Standard Error|Mean
778664|NCT00782210|Secondary|Trough FEV1 Response After 2 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed a -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 2 weeks|FAS||Liter||Standard Error|Mean
778665|NCT00782210|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response After 48 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks|FAS||Liter||Standard Error|Mean
778666|NCT00782210|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response After 24 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks|FAS||Liter||Standard Error|Mean
778667|NCT00782210|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response After 6 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -1h, -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks|FAS||Liter||Standard Error|Mean
778668|NCT00782210|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response After 2 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|FAS||Liter||Standard Error|Mean
778669|NCT00782210|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at Day 1|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose at day 1|FAS||Liter||Standard Error|Mean
778670|NCT00782210|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-12 h (AUC 0-12h) Response at Day 85 (12 Weeks)|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Means are adjusted using a non-mixed effects model with treatment (trt), tio stratum, baseline as fixed effects. FEV1 AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and -1h and -10 min, 5 min, 15 min, 30 min, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h relative to dose at Day 85 (12 weeks)|Patients in FAS with spirometry data after 3 hours at Visit 5 (12-hour pulmonary function test set)||Liter||Standard Error|Mean
778671|NCT00782210|Primary|Trough FEV1 Response at Day 85 (12 Weeks)|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h and - 10 mins prior to study drug at Day 85.|FAS||Liter||Standard Error|Mean
778672|NCT00782210|Primary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at Day 85 (12 Weeks)|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Day 85|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before Day 85 (12 weeks) for either co-primary efficacy variable.||Liter||Standard Error|Mean
778673|NCT00782288|Secondary|Clinically Significant Changes in the Microbiology of Sputum in Subjects|Count of clinically significant changes in sputum microbiology during the Treatment phase (Day 1 to Day 28) to include any new acquisition of B. cepacia or new acquisition of any multiple resistant organism.|28 days|There were no significant changes in the microbiology of sputum in any subjects over the course of treatment.||participants|||Number
778674|NCT00782288|Secondary|Clinically Significant Alterations in ECG Readings|Safety indices included an assessment for the number of clinically significant alterations in the subjects ECG readings from Day 1 to Day 28.|28 days|Count of clinically significant alterations in the ECG in all subjects during the Treatment Phase of the study.||participants|||Number
791696|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Total Protein)||Baseline up to Month 7|||percentage of participants|||Number
778675|NCT00782288|Secondary|Number of CF Subjects With Microarray Results From Nasal Epithelial Cells to Measure the Effect of Digitoxin on Gene Expression.|Rhinoprobe was used to collect nasal epithelial cells. The cells were collected pre and post-treatment and placed in Trizol for RNA isolation then used to measure the effect of digitoxin on gene expression. The full set of microarray data has been deposited in the National Center for Biotechnology Information (NCBI) Gene Expression Omnibus (GEO). The accession number for that data is GSE76347 (data available Dec 2018).|Day 0 and Day 28|The full set of microarray data has been deposited in the National Center for Biotechnology Information (NCBI) Gene Expression Omnibus (GEO). Results can be found under the accession number GSE76347. One subject's pair of specimens in the placebo group was not collected.||participants|||Number
778676|NCT00782288|Secondary|Changes in Erythrocyte Sedimentation Rate (ESR) During Treatment Period.|Median change in serum ESR (mm/hr) and IQR was calculated from Treatment Period (28 days).|Baseline and Day 28|All subjects had blood labs for ESR drawn on Visits 1,3,4 and 5. The changes in median ESR were calculated during the Treatment Period (28 days).||mm/hr||Inter-Quartile Range|Median
778677|NCT00782288|Secondary|Changes in C Reactive Protein (CRP) During Treatment.|Median changes in CRP and IQR were assessed from serum samples collected at Visits 1,3, 4 and 5.|Baseline and Day 28|All subjects had blood labs for CRP drawn on Visits 1,3,4 and 5. The changes in median CRP were calculated during the Treatment Period (28 days).||mg/dL||Inter-Quartile Range|Median
778678|NCT00782288|Primary|Change in Neutrophil Cell Count Day 28 Minus Day 1 (Treatment Period).|The change in log 10 neutrophil cell count from Day 28 minus Day 1 (during the treatment period) expressed as log (10^4 neutrophil/mL).|28 days (Day 28 minus Day 1)|The change in neutrophil cell count from Day 1 to Day 28 was performed using a Kruskal-Wallis equality of populations rank test. The cells counts are expressed as log 10 (neutrophil cell/mL).||log 10 (neutrophil cell/mL)||Inter-Quartile Range|Median
778679|NCT00782288|Primary|Effect of Digitoxin on Neutrophil Counts in Induced Sputum in Stable Cystic Fibrosis (CF) Patients.|The neutrophil counts were measured in the induced sputum of participants in each group on study 5 days (Days 1, 14, 21, 28 and 42).|42 days (Day 1- Day 42)|Neutrophil cell counts were compared between Baseline, Treatment and Recovery periods to determine if changes from baseline differed between the placebo and the two digitoxin dose levels.||log 10 (neutrophil cells/mL)||Inter-Quartile Range|Median
778680|NCT00782288|Primary|Change in Il-8 (Interleukin 8) Levels From Day 28 Minus Day 1 (Treatment Period).|Change in Il-8 values are expressed as a change in log 10 Il-8 pg/mL from Day 28 minus Day 1.|28 days (Day 28 minus Day 1)|For change in Il-8 from Day 28 minus Day 1, a Kruskal-Wallis equality of populations rank was performed.||log10 (pg/mL)||Inter-Quartile Range|Median
778681|NCT00782288|Secondary|Change in WBC (White Blood Cell) Count by Group During Treatment Period|Safety indices included changes in FEV1 (lung function), changes in WBC, alterations in ECG and sputum microbiology. There were no significant alterations in the ECG in any subjects over the course of the study. There were no subjects who acquired multiple resistant changes in microbiology of sputum and no acquisition of B. cepacia in any subjects. Therefore, these data were not analyzed. The median changes in FEV1 and median changes in WBC, ESR and CRP are reported.|Baseline and Day 28|Safety indices included changes in WBC during treatment for each group.||K/cu mm||Inter-Quartile Range|Median
778682|NCT00782288|Secondary|Mean Change in Quality of Life Scores, for Each Domain, From Day 1 to Day 42 Using the Cystic Fibrosis Questionnaire Revised (CFQ-R).|"CFQ-R is a disease-specific instrument designed to measure impact on overall health, daily life, perceived well-being and symptoms. Developed specifically for use in patients with a diagnosis of cystic fibrosis. There are 9 Quality of life domains: physical, role/school, vitality, emotion, social, body image, eating, treatment burden, health perceptions and 3 symptom scales: weight, respiratory, and digestion.
Scaling of items is done via 5 distinct 4-point Likert scales. Scores for each domain; after recoding, each item is summed to generate a domain score and standardized. Scores range from 0 to 100, with higher scores indicating better health. Based on clinician judgment of global clinical change, a moderate change was a standardized effect size of 0.50 units and an important change was a standardized effect size of 0.80 units evaluating pre- and post-treatment for CF exacerbation. Mean changes in CFQ-R Scores by Group were evaluated between Visit 6 and Visit 1, by Domain."|Baseline and Day 42|Mean change in CFQ-R scores from Visit 1 to Visit 6, by domain.||mean change of scores on a scale||Standard Deviation|Mean
778683|NCT00782288|Secondary|Safety Indices Including Change in FEV1 in Stable CF Patients.|Safety indices included changes in FEV1 (forced expiratory volume in 1 second), changes in WBC (white blood cell count), alterations in ECG and sputum microbiology. The median changes in FEV1 are reported.|Baseline and Day 28|Median changes in FEV1 in L by group for the 28 days of treatment.||liters||Inter-Quartile Range|Median
778684|NCT00782288|Secondary|Pharmacokinetics (PK) of Digitoxin in Serum in Stable CF Patients.|Digitoxin serum levels were drawn on Days 1 (pre-dose), 7, 14, 21 and 42. The range of digitoxin levels for each visit is listed and the number of subjects who had that level are marked by group (placebo, low dose and high dose).|Serum PK on Days 1 (pre-dose), 7, 14, 21 and 42|Subjects had serum digitoxin levels drawn at Day 1 (pre-dose) with no levels observed, as expected. Digitoxin was drawn on Day 7, 14, 21 and 42 to determine the number of subjects with a detectable level of digitoxin (ng/mL) in serum by group.||participants|||Number
778685|NCT00782288|Primary|Effect of Digitoxin on IL-8 (Interleukin 8) in Induced Sputum in Stable Cystic Fibrosis (CF) Patients.|The Il-8 measurements of sputum digitoxin levels for each group is shown for 5 days (Days 1, 14, 21, 28 and 42).|42 days (Day 1 to Day 42)|Sputum was collected for Il-8 biomarkers on Days 1,14, 21, 28 during the treatment phase and at Day 42. Measures were compared between Baseline, Treatment and Recovery periods to determine if changes from baseline differed between placebo and the two doses.||log 10 (pg/mL)||Inter-Quartile Range|Median
778686|NCT00782340|Secondary|Change in Systolic Blood Pressure (SBP) Measurements 3 Minutes Post Standing|Change: standing systolic blood pressure at end of study minus standing systolic blood pressure at randomization. A positive score indicates an improvement during the double-blind randomized phase relative to value at randomization.|7 days|||mmHg||Standard Deviation|Mean
778687|NCT00782340|Secondary|Clinician-Reported Clinical Global Improvement - Severity Scores|"The CGI-S is a 7 point scale ranging from a score of 1 (no symptoms) to 7 (severe symptoms). Patients were grouped according to OH severity at the end of the randomization period as follows;
Normal-Borderline OH (CGI-S 1-2), Mild-Moderate OH (CGI-S 3-4), Marked OH-Most Ill with OH (CGI-S 5-7)."|7 days|||participants|||Number
778690|NCT00782340|Secondary|Change in Activities Involving Walking a Short Time (OHDAS Item 3)|OHDAS Item 3 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. A negative score indicates an improvement during the double-blind randomized phase relative to value at randomization.|7 days|Missing data are imputed using the last observation carried forward method.||units on a scale||Standard Deviation|Mean
778691|NCT00782340|Secondary|Change in Activities Involving Standing a Short Time (OHDAS Item 1)|OHDAS Item 1 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. A negative score indicates an improvement during the double-blind randomized phase relative to value at randomization.|7 days|Missing data are imputed using the last observation carried forward method.||units on a scale||Standard Deviation|Mean
778692|NCT00782340|Secondary|Change in Orthostatic Hypotension Symptom Assessment (OHSA Composite) Score|OHSA composite scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. A negative score indicates an improvement during the double-blind randomized phase relative to value at randomization.|7 days|Missing data are imputed using the last observation carried forward method.||units on a scale||Standard Deviation|Mean
778693|NCT00782340|Secondary|Change in Ability to Conduct Activities of Daily Living Score (OHDAS Composite Score)|OHDAS composite scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. A negative score indicates an improvement during the double-blind randomized phase relative to value at randomization.|7 days|Missing data are imputed using the last observation carried forward method.||units on a scale||Standard Deviation|Mean
778694|NCT00782340|Primary|Change in Orthostatic Hypotension Questionnaire Score (OHQ)|"The OHQ is the average of two sub-scales, the Orthostatic Hypotension Symptom Assessment Scale (OHSA) and the Orthostatic Hypotension Daily Activities Scale (OHDAS). Each asks the patient to rate their symptoms or disease impact over the past week. The OHSA sub-scale is the average of six items: 1) Dizziness, lightheadedness, feeling faint or feeling like you might black out; 2) Problems with vision; 3) Weakness; 4) Fatigue; 5) Trouble concentrating; and 6) Head/neck discomfort. The OHDAS sub-scale is the average of four items: 1) Standing for a short time; 2) Standing for a long time; 3) Walking for a short time; and 4) Walking for a long time. Each item is scored on a Likert scale from 0 to 10, with 10 being the most severe.
For the change from randomization, negative numbers represent improvement from randomization in OHQ score."|7 days|Missing data are imputed using the last observation carried forward method.||units on a scale||Standard Deviation|Mean
778695|NCT00782379|Secondary|Disease Free Survival at Day 100|Disease free survival refers to patients with no evidence of disease after transplant, at the Day 100 time point.|Day 100|17 patients were alive at Day 100 and therefore were eligible to be evaluated for disease free survival at D100||participants|||Number
778696|NCT00782379|Secondary|Disease Free Survival at 12 Months|Disease free survival refers to patients with no evidence of disease after transplant, at the 12 month time point.|12 months|14 patients were alive at one year and therefore were eligible to be evaluated for disease free survival at 1 year||participants|||Number
778697|NCT00782379|Secondary|Overall Survival at 12 Months|Overall survival, defined as a patient being alive after transplant, is without regard to disease status.|12 months|20 patients received haploidentical transplant and therefore were eligible to be evaluated for overall survival at 1 year||participants|||Number
778698|NCT00782379|Secondary|Achievement of >90% (Full) Donor Chimerism in the T-Cell Lineage as Measured by PCR at Day 90 Post-transplantation|Chimerism analysis of peripheral blood mononuclear cells using PCR for STR/VNTR will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism.|Day 90|13 patients had chimerism drawn at Day 90||participants|||Number
778699|NCT00782379|Secondary|Achievement of >90% (Full) Donor Chimerism in the T-Cell Lineage as Measured by PCR at Day 60 Post-transplantation|Chimerism analysis of peripheral blood mononuclear cells using PCR for STR/VNTR will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism.|Day 60|18 patients had chimerism drawn at Day 60||participants|||Number
778700|NCT00782379|Secondary|Non-relapse Mortality at Day 100 After Peripheral Blood Stem Cell Transplantation (PBSCT)||Day 100|2 patients died before Day 100 and therefore are eligible to be evaluated for non-relapse mortality||participants|||Number
778701|NCT00782379|Secondary|Achievement of >90% (Full) Donor Chimerism in the T-Cell Lineage as Measured by PCR at Day 30 Post-transplantation|Chimerism analysis of peripheral blood mononuclear cells using PCR (polymerase chain reaction) for STR/VNTR (short tandme repeat/variable number tandem repeat) will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism.|Day 30|18 patients had Day 30 chimerism drawn||participants|||Number
778702|NCT00782379|Secondary|Non-relapse Mortality at 1 Year After Peripheral Blood Stem Cell Transplantation (PBSCT)|Non-relapse mortality refers to whether a patient dies of causes related to something other than the primary disease.|1 year|6 patients died prior to one year and therefore are eligible to be evaluated for non-relapse mortality.||participants|||Number
778703|NCT00782379|Secondary|Overall Survival at Day 100|Overall survival is assessed, without regard to disease status, post-transplant, at Day 100.|Day 100|20 patients received a haploidentical transplant and therefore are eligible to be evaluated for Day 100 survival||participants|||Number
778704|NCT00782379|Primary|Number of Patients Who Experienced Severe Graft-versus-host Disease (GVHD)(Grade 3 or 4)|Number of patients who experienced post-transplant complication (GVHD) as seen by clinical evidence|Day 100|17 patients were alive at Day 100 and eligible to be evaluated for grade 3-4 graft versus host disease||participants|||Number
778705|NCT00782379|Primary|Incidence of Graft Rejection for Patients at Day 100|Number of patients who experienced graft rejection by Day 100|Day 100|20 patients were treated and able to be analyzed for graft rejection||participants|||Number
778706|NCT00782418|Primary|Change From Baseline in Insulin Concentration||Pre and Post glucose infusion|All subjects treated||μIU(insulin)/mL||Full Range|Least Squares Mean
778707|NCT00782418|Primary|Change From Baseline in C-peptide Concentration||Pre and Post glucose infusion|All subjects treated||ng/mL||Full Range|Least Squares Mean
778708|NCT00782418|Primary|Change From Baseline in Insulin Secretion Rate (ISR) Normalized to Ambient Plasma Glucose|"Comparison of Glucose Dependent Insulin Secretion (GDIS) measured after HGC at steady-state to GDIS measured after GGI at the highest glucose infusion rate.
Insulin Secretion Rate (ISR)/ Blood Glucose (BG)"|Steady-state of HGC: 90 – 120 minutes post dose; highest glucose infusion rate of GGI: 120 – 160 minutes post dose|All subjects treated||(ng/min) / (mg/dL)||Full Range|Geometric Mean
778709|NCT00782483|Primary|Average Laser Setting to be Used to Treat Port Wine Stains as Measured by Mathematical Calculations Based on Imaging and Temperature Analysis of Malformation.|6 subjects were enrolled but no data was ever collected due to early termination of the study due to the PI's relocation.|Three treatments up to one year, whichever is first|6 subjects were enrolled but no data was ever collected due to early termination of the study due to the PI's relocation.|||||
778710|NCT00782496|Secondary|Percent of Level 2 Participants Who Rated Helpfulness of Advanced Meter Features as 1 or 2|Level 2 participants, who used advanced meter features, responded to questionnaires. They rated helpfulness of the meal marker reminder feature on a 5 point scale, 1 being strongly agree and 5 being strongly disagree.|Over six month period|63 surveys were available for analysis.||percent of Level 2 participants|||Number
778711|NCT00782496|Primary|Average Number of Weekly Post-Prandial Blood Glucose Tests Performed by Subjects Using Either Basic or Advanced Meter Features||6 months|For level 1, 14 subjects were lost to follow-up, that is they did not continue through the study's 4 visits, and data was not available. For level 2, 15 subjects were likewise lost to follow-up and data was not available. For units analyzed, 74 and 68 refer to the number of logbooks available.||number of post-prandial tests per week||Standard Error|Mean
778712|NCT00782509|Secondary|Change From Baseline in Potassium|Laboratory testing: Average change from baseline of potassium measured. The laboratory tests at Day 1 were considered the baseline measurements.|Day 1 and at 12, 24 and 48 weeks|Treated set.||mmol/L||Standard Deviation|Mean
778713|NCT00782509|Secondary|Changes in Safety Parameters Related to Treatment|Occurence of bronchoconstriction, cardiac disorders and investigations related to treatment. Bronchoconstriction is defined as any of the following events: Drop in trough FEV1 >= 15%, Rescue medication use within 30 min of inhaling randomized treatment on a clinic test day or Cough, wheeze, or dyspnoea AE within 30 min of inhaling randomized treatment on a clinic test day.|48 weeks|Treated set.||percentage of participants|||Number
778714|NCT00782509|Secondary|Number of Moderate Chronic Obstructive Pulmonary Disease (COPD) Exacerbations|Mean number of moderate COPD exacerbations per patient years. Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. Moderate exacerbations were defined as exacerbations which did not lead to hospitalization but included treatment with antibiotics and/or systemic steroids.|Baseline to end of study at 48 weeks.|Treated set- all patients who received at least one dose of study medication||COPD exacerbations||Standard Error|Mean
778715|NCT00782509|Secondary|Number of COPD Exacerbations Requiring Hospitalization|Mean number of COPD exacerbations requiring hospitalization per patient years. Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations required hospitalization.|Baseline to end of study at week 48 visit|Treated set- all patients who received at least one dose of study medication||COPD exacerbations||Standard Error|Mean
778716|NCT00782509|Secondary|Number of COPD Exacerbations|Mean number of COPD exacerbations per patient years. Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria.|Baseline to end of study at week 48 visit|Treated set- all patients who received at least one dose of study medication||COPD exacerbations||Standard Error|Mean
778717|NCT00782509|Secondary|Time to First Moderate Chronic Obstructive Pulmonary Disease (COPD) Exacerbation|Qualifying events of COPD were specifically pre-defined in the protocol.Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. Moderate exacerbations were defined as exacerbations which did not lead to hospitalization but included treatment with antibiotics and/or systemic steroids. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor.Due to the limited number of events some statistics were not able to be calculated and are listed as N/A or are blank. The measured values presented are actually the First Quartile and 95% confidence interval..|Baseline to end of study at 48 weeks.|Treated set- all patients who received at least one dose of study medication||days||95% Confidence Interval|Mean
778718|NCT00782509|Secondary|Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Leading to Hospitalization|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations required hospitalization. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor. Due to the limited number of events some statistics were not able to be calculated and are listed as N/A or are blank. The measured values presented are actually the First Quartile and 95% confidence interval.|Baseline to end of study at 48 weeks.|Treated set- all patients who received at least one dose of study medication||days||95% Confidence Interval|Mean
778719|NCT00782509|Secondary|Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation|"Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor. Due to the limited number of events some statistics were not able to be calculated and are listed as N/A or are blank.
The measured values presented are actually the First Quartile and 95% confidence interval."|Baseline to end of study at 48 weeks.|Treated set- all patients who received at least one dose of study medication||days||95% Confidence Interval|Mean
778720|NCT00782509|Secondary|Patient's Global Rating at Week 48|Patients were asked to rate their respiratory condition relative to their condition prior to the first dose of study medication. The scale is a seven point scale: 1=very much better, 2=much better,3=a little better,4=no change,5=a little worse,6=much worse,7=very much worst.|Week 48 visit|FAS||Point on scale||Standard Error|Mean
778721|NCT00782509|Secondary|Patient's Global Rating at Week 24|Patients were asked to rate their respiratory condition relative to their condition prior to the first dose of study medication. The scale is a seven point scale: 1=very much better, 2=much better,3=a little better,4=no change,5=a little worse,6=much worse,7=very much worst.|Week 24 visit|FAS||Point on scale||Standard Error|Mean
778722|NCT00782509|Secondary|Patient's Global Rating at Week 12|Patients were asked to rate their respiratory condition relative to their condition prior to the first dose of study medication. The scale is a seven point scale: 1=very much better, 2=much better,3=a little better,4=no change,5=a little worse,6=much worse,7=very much worst.|Week 12 visit|FAS||Point on scale||Standard Error|Mean
778723|NCT00782509|Secondary|Patient's Global Rating at Week 6|Patients were asked to rate their respiratory condition relative to their condition prior to the first dose of study medication. The scale is a seven point scale: 1=very much better, 2=much better,3=a little better,4=no change,5=a little worse,6=much worse,7=very much worst.|Week 6 visit|FAS||Point on scale||Standard Error|Mean
778724|NCT00782509|Secondary|Weekly Mean of Daily (24h) Rescue Use|The patient was to record in the e-Diary the number of puffs of salbutamol (albuterol) Metered-Dose Inhaler used each day and night. The weekly mean was calculated by taking the average of the number of puffs of rescue medication used each 24 hour period during week 48.|Week 48|FAS||Number of puffs||Standard Error|Mean
778725|NCT00782509|Secondary|Weekly Mean of Daily Nighttime Rescue Use|The patient was to record in the e-Diary the number of puffs of salbutamol (albuterol) Metered-Dose Inhaler used each day and night. The weekly mean was calculated by taking the average of the number of puffs of rescue medication used each night during week 48.|Week 48|FAS||Number of puffs||Standard Error|Mean
778726|NCT00782509|Secondary|Weekly Mean of Daily Daytime Rescue Use|The patient was to record in the e-Diary the number of puffs of salbutamol (albuterol) Metered-Dose Inhaler used each day and night. The weekly mean was calculated by taking the average of the number of puffs of rescue medication used each day during week 48.|Week 48|FAS||Number of puffs||Standard Error|Mean
778727|NCT00782509|Secondary|Weekly Mean Evening Peak Expiratory Flow Rate (PEF)|Weekly mean evening peak expiratory flow rate (PEF) at 48 weeks. PEFR measurements recorded by means of an e-Diary on a daily basis. This e-Diary was used to record the twice daily PEFs, study drug use, and rescue salbutamol (albuterol) use. The best of three readings for each measurement was recorded.|at bedtime from Screening to week 48|FAS||L/min||Standard Error|Mean
778728|NCT00782509|Secondary|Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEF)|Weekly mean pre-dose morning peak expiratory flow rate (PEF) at 48 weeks. PEFR measurements recorded by means of an e-Diary on a daily basis. This e-Diary was used to record the twice daily PEFs, study drug use, and rescue salbutamol (albuterol) use. The best of three readings for each measurement was recorded.|immediately upon arising (before drug administration) from Screening to week 48|FAS||L/min||Standard Error|Mean
778729|NCT00782509|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-12 h (AUC 0-12h) Response at Day 85 (12 Weeks)|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a non-mixed effects model with treatment (trt), tio stratum, baseline as fixed effects. FVC AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and -1h and -10 min, 5 min, 15 min, 30 min, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h relative to dose at Day 85 (12 weeks)|Patients in FAS with spirometry data after 3 hours at Visit 5 (12-hour pulmonary function test set)||Liter||Standard Error|Mean
778730|NCT00782509|Secondary|FVC Peak (0-3h) Response After 48 Weeks|Response was defined as change from baseline. Baseline FVC peak (0-3h) was defined as the mean of the available pre-dose FVC peak (0-3h) values prior to first dose of randomized treatment. FVC Peak (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks|FAS||Liter||Standard Error|Mean
778731|NCT00782509|Secondary|FVC Peak (0-3h) Response After 24 Weeks|Response was defined as change from baseline. Baseline FVC peak (0-3h) was defined as the mean of the available pre-dose FVC peak (0-3h) values prior to first dose of randomized treatment. FVC Peak (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks|FAS||Liter||Standard Error|Mean
778732|NCT00782509|Secondary|FVC Peak (0-3h) Response After 12 Weeks|Response was defined as change from baseline. Baseline FVC peak (0-3h) was defined as the mean of the available pre-dose FVC peak (0-3h) values prior to first dose of randomized treatment. FVC Peak (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 12 weeks|FAS||Liter||Standard Error|Mean
778733|NCT00782509|Secondary|FVC Peak (0-3h) Response After 6 Weeks|Response was defined as change from baseline. Baseline FVC peak (0-3h) was defined as the mean of the available pre-dose FVC peak (0-3h) values prior to first dose of randomized treatment. FVC Peak (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks|FAS||Liter||Standard Error|Mean
780230|NCT00794118|Primary|Physician Global Assessment (PGA) of Disease Activity at Month 3|PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible.|Month 3|ITT population included all participants who received at least 1 dose of the study medication.||cm||Standard Deviation|Mean
778734|NCT00782509|Secondary|FVC Peak (0-3h) Response After 2 Weeks|Response was defined as change from baseline. Baseline FVC peak (0-3h) was defined as the mean of the available pre-dose FVC peak (0-3h) values prior to first dose of randomized treatment. FVC Peak (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|FAS||Liter||Standard Error|Mean
778735|NCT00782509|Secondary|FVC Peak (0-3h) Response At Day 1|Response was defined as change from baseline. Baseline FVC peak (0-3h) was defined as the mean of the available pre-dose FVC peak (0-3h) values prior to first dose of randomized treatment. FVC Peak (0-3h) values were obtained within 0 - 3 hours aftertreatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose at Day 1|FAS||Liter||Standard Error|Mean
778736|NCT00782509|Secondary|Trough FVC Response After 48 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 48 weeks|FAS||Liter||Standard Error|Mean
778737|NCT00782509|Secondary|Trough FVC Response After 40 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 40 weeks|FAS||Liter||Standard Error|Mean
778738|NCT00782509|Secondary|Trough FVC Response After 32 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 32 weeks|FAS||Liter||Standard Error|Mean
778739|NCT00782509|Secondary|Trough FVC Response After 24 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 24 weeks|FAS||Liter||Standard Error|Mean
778740|NCT00782509|Secondary|Trough FVC Response After 18 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 18 weeks|FAS||Liter||Standard Error|Mean
778741|NCT00782509|Secondary|Trough FVC Response After 12 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 12 weeks|FAS||Liter||Standard Error|Mean
778742|NCT00782509|Secondary|Trough FVC Response After 6 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 6 weeks|FAS||Liter||Standard Error|Mean
780231|NCT00794118|Primary|Patient Global Assessment (PtGA) of Disease Activity Score at Month 12|PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad.|Month 12|ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.||cm||Standard Deviation|Mean
778743|NCT00782509|Secondary|Trough FVC Response After 2 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 2 weeks|FAS||Liter||Standard Error|Mean
778744|NCT00782509|Secondary|FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response After 48 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks|FAS||Liter||Standard Error|Mean
778745|NCT00782509|Secondary|FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response After 24 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks|FAS||Liter||Standard Error|Mean
778746|NCT00782509|Secondary|FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response After 12 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 12 weeks|FAS||Liter||Standard Error|Mean
778747|NCT00782509|Secondary|FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response After 6 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks|FAS||Liter||Standard Error|Mean
778748|NCT00782509|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-3 Hours (AUC 0-3h) Response After 2 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|FAS||Liter||Standard Error|Mean
778749|NCT00782509|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-3 Hours (AUC 0-3h) Response At Day 1|Response was defined as change from baseline. Baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose at Day 1|FAS||Liter||Standard Error|Mean
778750|NCT00782509|Secondary|Peak FEV1 (0-3h) Response After 48 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks|FAS||Liter||Standard Error|Mean
778751|NCT00782509|Secondary|Peak FEV1 (0-3h) Response After 24 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks|FAS||Liter||Standard Error|Mean
778819|NCT00775437|Secondary|Uric Acid: Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||µmol/L||Standard Deviation|Mean
778752|NCT00782509|Secondary|Peak FEV1 (0-3h) Response After 12 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 12 weeks|FAS||Liter||Standard Error|Mean
778753|NCT00782509|Secondary|Peak FEV1 (0-3h) Response After 6 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks|FAS||Liter||Standard Error|Mean
778754|NCT00782509|Secondary|Peak FEV1 (0-3h) Response After 2 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|FAS||Liter||Standard Error|Mean
778755|NCT00782509|Secondary|Peak FEV1 (0-3h) Response At Day 1|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose at Day 1|FAS||Liter||Standard Error|Mean
778756|NCT00782509|Secondary|Trough FEV1 Response After 48 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 48 weeks|FAS||Liter||Standard Error|Mean
778757|NCT00782509|Secondary|Trough FEV1 Response After 40 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 40 weeks|FAS||Liter||Standard Error|Mean
778758|NCT00782509|Secondary|Trough FEV1 Response After 32 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 32 weeks|FAS||Liter||Standard Error|Mean
778759|NCT00782509|Secondary|Trough FEV1 Response After 24 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 24 weeks|FAS||Liter||Standard Error|Mean
778760|NCT00782509|Secondary|Trough FEV1 Response After 18 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 18 weeks|FAS||Liter||Standard Error|Mean
778820|NCT00775437|Secondary|Creatinine: Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||µmol/L||Standard Deviation|Mean
778761|NCT00782509|Secondary|Trough FEV1 Response After 6 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 6 weeks|FAS||Liter||Standard Error|Mean
778762|NCT00782509|Secondary|Trough FEV1 Response After 2 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed a -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 2 weeks|FAS||Liter||Standard Error|Mean
778763|NCT00782509|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response After 48 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks|FAS||Liter||Standard Error|Mean
778764|NCT00782509|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response After 24 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks|FAS||Liter||Standard Error|Mean
778765|NCT00782509|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response After 6 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -1h, -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks|FAS||Liter||Standard Error|Mean
778766|NCT00782509|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response After 2 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|FAS||Liter||Standard Error|Mean
778767|NCT00782509|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response At Day 1|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose at Day 1|FAS||Liter||Standard Error|Mean
778768|NCT00782509|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-12 h (AUC 0-12h) Response at Day 85 (12 Weeks)|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Means are adjusted using a non-mixed effects model with treatment (trt), tio stratum, baseline as fixed effects. FEV1 AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and -1h and -10 min, 5 min, 15 min, 30 min, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h relative to dose at Day 85 (12 weeks)|Patients in FAS with spirometry data after 3 hours at Visit 5 (12-hour pulmonary function test set)||Liter||Standard Error|Mean
778821|NCT00775437|Secondary|Total Bilirubin: Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||µmol/L||Standard Deviation|Mean
778769|NCT00782509|Primary|Trough FEV1 Response at Day 85 (12 Weeks)|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h and - 10 mins prior to study drug at Day 85.|FAS||Liter||Standard Error|Mean
778770|NCT00782509|Primary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at Day 85 (12 Weeks)|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Day 85|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before Day 85 (12 weeks) for either co-primary efficacy variable.||Liter||Standard Error|Mean
778771|NCT00782626|Primary|Overall Response|Overall response is classified as complete response (CR), partial response (PR), stable disease (SD) or Progressive Disease (PD) on therapy.Description: Overall response is classified as complete response (CR), partial response (PR), stable disease (SD) or Progressive Disease (PD) on therapy. Response for target lesions (up to5) is based on 3 dimensions with an elliptical model volume used: 0.5L*W*T; (L) tumor extent in plane perpendicular to the selected plane; (W) longest measurement of the tumor width; (T) transverse measurement perpendicular to the width. CR is disappearance all target and non-target lesions and no new lesions. PR is >/= 65% decrease in sum of the products (referent baseline). PD 40% or more increase in any target lesion (referent smallest product observed on therapy). SD is none of the above. PR and SD classification as long as absent new lesions and unequivocal progression for non-target lesions else PD.|Disease evaluations (MRI brain, including volumetric analysis) occurred at baseline, at the end of course 1, every 3 courses during treatment up to 12 courses and at early treatment discontinuation.|The analysis dataset is comprised of all evaluable patients. All treated patients were evaluable.||participants|||Number
778772|NCT00782639|Primary|Baseline and Change From Baseline Measurements for the One Participant With Contrast-Induced Nephropathy (CIN) at the 48 to 72 Hours After Injection of Contrast Media Visit|Only 1 participant presented with incidence of CIN (change from baseline greater than or equal to 0.5 mg/dL) following the administration of iopamidol-370 while undergoing cardiac angiography. The participant's measurements at baseline and at 48 to 72 hours after the injection of contrast agent, as well as the difference between the two, are displayed here. Since CIN is a prospectively-defined outcome measure of the trial, patients experiencing CIN were not reported as having an adverse event.|Baseline (just prior to injection of contrast media) and 48 to 72 hours after injection of contrast media|||milligrams per deciliter (mg/dL)|||Number
778773|NCT00782639|Secondary|Number of Participants Who Died From Acute Renal Failure|This outcome measure provides the total number of participants who died as a result of acute renal failure.|Any timepoint (Screening [up to 72 hours prior to injection of contrast media], Baseline [just before injection], or 48 to 72 hours or 7 days after injection)|||Participants|||Number
778774|NCT00782639|Secondary|Number of Participants Requiring Dialysis|This outcome measure provides the total number of participants requiring dialysis occurring from acute renal failure.|48 to 72 hours after injection of contrast media|||Participants|||Number
778775|NCT00782639|Secondary|The Number of Participants With a >=25% Increase in Serum Creatinine (SCr)|This outcome measure provides the total number of participants that had a increase from baseline in SCr greater or equal to 25% within 48 to 72 hours following the cardiac angiography procedure.|Baseline (just prior to injection of contrast media) and 48 to 72 hours after injection of contrast media|||Participants|||Number
778776|NCT00782639|Secondary|The Number of Participants With a >=25% Decrease in Estimated Glomerular Filtration Rate (eGFR)|This outcome measure provides the total number of participants that had a decrease from baseline in eGFR greater or equal to 25% within 48 to 72 hours following the cardiac angiography procedure.|Baseline (just prior to injection of contrast media) and 48 to 72 hours after injection of contrast media|||Participants|||Number
778777|NCT00782639|Primary|The Number of Participants With Contrast-induced Nephropathy (CIN)|The number of participants who presented with CIN (defined as an increase in Serum Creatinine (SCr) from baseline greater than or equal to 0.5 mg/dL following the administration of iopamidol-370 or iodixanol 320 while undergoing cardiac angiography). Since CIN is a prospectively-defined outcome measure of the trial, patients experiencing CIN were not reported as having an adverse event.|48 to 72 hours After Injection of Contrast Media|||Participants|||Number
778778|NCT00782717|Secondary|Percent of Patients With a Decrease of More Than 5 Letters in Best-corrected Visual Acuity (BCVA).|BCVA was measured using the procedure developed for the Early Treatment Diabetic Retinopathy Study.|From Day 7 to Day 90 (or Early Exit)|All patients who were exposed to the study drug, completed the implant surgery, and had at least one on-therapy post-surgical visit at which optical coherence tomography (OCT) was performed (ITT).||Percentage of patients|||Number
778779|NCT00782717|Primary|Percent of Patients Who Developed Macular Edema (ME) Within 90 Days Following Cataract Surgery|Macular edema (thickening of the center of the back of the eye) was defined as 30% or greater increase from pre-operative baseline measurement in central subfield macular thickness as measured using Optical Coherence Tomography(OCT).|3 Months|All patients who were exposed to the study drug, completed the implant surgery, and had at least one on-therapy post-surgical visit at which optical coherence tomography (OCT) was performed (ITT).||Percentage of patients|||Number
778780|NCT00782821|Secondary|Patient Allograft Survival at 12 Months|Patient's allograft was still functioning at 12 months post study enrollment|12 months|||participants|||Number
778781|NCT00782821|Secondary|Patient Survival at 12 Months|Patient was still alive 12 months post study enrollment.|12 months|||participants|||Number
778782|NCT00782821|Secondary|Acute Cellular Rejection by Banff '97 Criteria (Updated 2005)|"Acute cellular rejection IA - cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (>4 mononuclear cells/tubular cross section or group of 10 tubular cells).
IB - cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of severe tubulitis (>10 mononuclear cells/tubular cross section or group of 10 tubular cells) IIA - cases with mild to moderate intimal arteritis (v1) IIB - cases with server intimal arteritis comprising >25% of the luminal area (v2) III - case with transmural arteritis and/or arterial fibrinoid change and necrosis of medical smooth muscle cells (v3 with accompanying lymphoctic inflammation)"|6 months|||participants|||Number
778783|NCT00782821|Secondary|Antibody-mediated Rejection by Banff '97 Criteria (Updated 2005)|"Antibody mediated rejection demonstrated to be due to, atleast in part, to anti-donor antibody at 6 months by Banff 97' criteria. Rejection due, at least in part, to documented anti-donor antibody (‘suspicious for’ if antibody not demonstrated); may coincide with categories 3, 4 and 5.
Grade I. ATN-like – C4d+, minimal inflammation Grade II. Capillary- margination and/or thromboses, C4d+ Grade III. Arterial – v3, C4d+"|6 months|||participants|||Number
778784|NCT00782821|Primary|Incidence of Acute Rejection (Banff ’97) or Antibody Mediated Rejection|"Antibody mediated rejection demonstrated to be due to, atleast in part, to anti-donor antibody at 6 months by Banff 97' criteria.
Acute rejection IA - cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (>4 mononuclear cells/tubular cross section or group of 10 tubular cells).
IB - cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of severe tubulitis (>10 mononuclear cells/tubular cross section or group of 10 tubular cells) IIA - cases with mild to moderate intimal arteritis (v1) IIB - cases with server intimal arteritis comprising >25% of the luminal area (v2) III - case with transmural arteritis and/or arterial fibrinoid change and necrosis of medical smooth muscle cells (v3 with accompanying lymphoctic inflammation)"|6 months|||participants|||Number
778785|NCT00782834|Primary|Response Rate|Response rate of nilotinib by RECIST criteria evaluated every 2 months for the first 6 months then every 3 months for the duration of treatment period.|1year|||Participants|||Number
778786|NCT00782834|Primary|Progression Free Survival Rate at 6 Months|Number of participants that demonstrate progression free survival at 6 months|6 months|||Participants|||Number
778787|NCT00775346|Primary|Sensitivity and Specificity Data of the Saturation Pattern Detection (SPD) Feature as a Predictor of Repetitive Reductions in Airflow (RRiA).|Sensitivity and specificity were computed from the count of instances in which the Saturation Pattern Detection (SPD) index value (vs. Polysomnography) within a discrete ten minute interval correctly identified a Repetitive Reduction in Airflow (RRiA) as being present within that interval (True Positive), absent (True Negative), or incorrectly identified presence or absence (False Positive and False Negative, respectively). Sensitivity is True Positive divided by True Positive plus False Negative TP/(TP+FN). Specificity is True Positive divided by True Negative plus False Positive TP/(TN+FP).|9 Hours|||Ratio||90% Confidence Interval|Mean
778788|NCT00775411|Secondary|Percentage of Participants With Fluorescein Leakage Improved, Unchanged and Worsened From Baseline as Assessed by Fluorescein Angiography at Week 26|Fluorescein angiography (FA) is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. Photographs are taken with a specialized low-power microscope with an attached camera designed to photograph the interior of the eye, including the retina and optic disc. FA at Week 26 was compared to FA at Baseline. The percentage of participants in each of the following categories is reported: Improved (Leakage area decreased >=10%), Unchanged (Leakage area changed < 10%) and Worsened (Leakage area increased >=10%).|Baseline, Week 26|Participants from the Intent to treat population consisting of all enrolled participants with data available for analysis at Week 26.||Percentage of participants|||Number
778789|NCT00775411|Secondary|Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 26|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|Baseline, Week 26|Intent to treat population consisting of all enrolled participants.||Number of letters||Standard Deviation|Mean
778790|NCT00775411|Primary|Change From Baseline in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT) at Week 4|Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed on the study eye after pupil dilation at baseline and Week 4.|Baseline, Week 4|Participants from the Intent to treat Population consisting of all enrolled participants with data available at Week 4 for analyses.||Microns||Standard Deviation|Mean
778791|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) Family Cohesion Category: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||units on a scale||Standard Deviation|Mean
778792|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) Family Activities Category: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||units on a scale||Standard Deviation|Mean
778822|NCT00775437|Secondary|Creatine Phosphokinase: Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||U/L||Standard Deviation|Mean
778793|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) Parental Impact - Time Category: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||units on a scale||Standard Deviation|Mean
778794|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) Parental Impact - Emotional Category: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||units on a scale||Standard Deviation|Mean
778795|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) Change in Health Category: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||units on a scale||Standard Deviation|Mean
778796|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) General Health Perceptions Category: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||units on a scale||Standard Deviation|Mean
778797|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) Self Esteem Category: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||units on a scale||Standard Deviation|Mean
778798|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) Mental Health Category: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||units on a scale||Standard Deviation|Mean
778799|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) Global Behavior Item: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||units on a scale||Standard Deviation|Mean
778800|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) Behavior Category: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||units on a scale||Standard Deviation|Mean
778801|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) Bodily Pain/Discomfort Category: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||units on a scale||Standard Deviation|Mean
778865|NCT00775606|Secondary|CD4+ T-cell Change|This measures the change in CD4+ T-cells from baseline to week 24 of treatment.|24 weeks after treatment initiation (baseline and week 24)|||cells/mm3||Standard Deviation|Mean
778802|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) Role/Social Limitations – Physical Category: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||units on a scale||Standard Deviation|Mean
778803|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) Role/Social Limitations/Emotional/Behavioral Category: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||units on a scale||Standard Deviation|Mean
778804|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) Physical Functioning Category: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120.|||units on a scale||Standard Deviation|Mean
778805|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) Global Health Category: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||units on a scale||Standard Deviation|Mean
778806|NCT00775437|Secondary|Pain on Passive Motion (POM75) Joint Count: Mean Change From Baseline to Each Visit|"Seventy-five joints were assessed by physical examination. The joints to be examined for POM were the same as those examined for tenderness. POM of the joint was classified as present (1), absent (0), or replaced/injected (9). Scores range from 0 to 675, with higher scores representing higher disease activity. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit."|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||units on a scale||Standard Deviation|Mean
778807|NCT00775437|Secondary|Swollen Joint Count (SJC66): Mean Change From Baseline to Each Visit|"Sixty-six joints were assessed by physical examination. The joints to be examined for swelling were the same as those examined for tenderness, except that the hip, subtalar, sacroiliac, lumbar spine, thoracic spine, and cervical spine joints were excluded. Joint swelling was classified as present (1), absent (0) or replaced/injected (9). Scores range from 0 to 594, with higher scores representing higher disease activity. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit."|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||units on a scale||Standard Deviation|Mean
778808|NCT00775437|Secondary|Tender Joint Count (TJC75): Mean Change From Baseline to Each Visit|"Seventy-five joints or regions were assessed by pressure and joint manipulation on physical examination. Joint tenderness was classified as either present (1), absent (0) or replaced/injected (9). Scores range from 0 to 675, with higher scores representing higher disease activity. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit."|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||units on a scale||Standard Deviation|Mean
778809|NCT00775437|Secondary|C-reactive Protein (CRP): Mean Change From Baseline to Each Visit|CRP is a laboratory parameter and considered as an efficacy variable. CRP is a general marker of inflammation that is sensitive to acute changes in inflammatory response. CRP is reported using mg/dL. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||mg/dL||Standard Deviation|Mean
778810|NCT00775437|Secondary|Limitation of Passive Motion (LOM69) Joint Count: Mean Change From Baseline to Each Visit|"Sixty-nine joints were assessed by physical examination. The joints to be examined for LOM were the same as those examined for tenderness, except that the sacroiliac, sternoclavicular, and acromio clavicular joints were excluded. LOM of the joint was classified as present (1), absent (0), or replaced/injected (9). Scores range from 0 to 621, with higher scores representing higher disease activity. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit."|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||units on a scale||Standard Deviation|Mean
780232|NCT00794118|Primary|Patient Global Assessment (PtGA) of Disease Activity Score at Month 9|PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad.|Month 9|ITT population included all participants who received at least 1 dose of the study medication.||cm||Standard Deviation|Mean
778811|NCT00775437|Secondary|Active Joint Counts (AJC73): Mean Change From Baseline to Each Visit|A joint assessment was recorded at all study visits to assess the number of active joints, with a total possible score of 0 (no active joints) to 73 (all active joints). Active joints are defined as joints with positive results for tenderness, swelling, pain on passive motion, or limitation of passive motion. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||units on a scale||Standard Deviation|Mean
778812|NCT00775437|Secondary|Disability Index of Child Health Assessment Questionnaire (DICHAQ): Mean Change From Baseline to Each Visit|The DICHAQ is a self-reported participant-oriented outcome measure, calculated as the mean of the following 8 category scores (range: 0 to 3): Dressing and Grooming, Arising, Eating, Walking, Hygiene, Reach, Grip, and Activities. The score of each category is calculated as the maximum of the scores for the questions within that category. If aids and devices and/or help from another person are used for a category, a lower category score is adjusted to 2 for that category. A participant must have scores for at least 6 categories in order to compute the DICHAQ score. Total score is derived as average of all categories: 0 (no disability) to 3 (complete disability). Baseline is the last value prior to the first dose of study drug. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||units on a scale||Standard Deviation|Mean
778813|NCT00775437|Secondary|Parent's Global Assessment of Disease Activity: Mean Change From Baseline to Each Visit|The parent’s assessment of how the participant’s arthritis is doing overall on a VAS. The VAS is a 100 mm scale, with scores ranging from 0 (very good) to 100 (very bad). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||units on a scale||Standard Deviation|Mean
778814|NCT00775437|Secondary|Physician's Global Assessment of Disease Activity: Mean Change From Baseline to Each Visit|The physician’s assessment of participant's overall disease activity on a visual analog scale (VAS). The VAS is a 100 mm scale, with scores ranging from 0 (very good) to 100 (very bad). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||units on a scale||Standard Deviation|Mean
778815|NCT00775437|Secondary|Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 90% Response (PedACR90)|The PedACR90 response is defined by the PedACR as ≥ 90% improvement in at least 3 of 6 JIA core set criteria, and ≥ 30% worsening in not more than 1 of 6 JIA core set criteria. The 6 variables for the JIA core set criteria include PGA of participant's disease activity, Parent's Global Assessment of participant's disease activity, number of active joints (joints with swelling not due to deformity or joints with LOM and joints with POM, tenderness, or both), number of joints with LOM, DICHAQ, and CRP. Baseline is the last value prior to the first dose of study drug. Missing data were imputed up to Week 60 using LOCF and by NRI; observed values are presented for timepoints past Week 60. n=number of participants for either observed or imputed methods at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||percentage of participants|||Number
778816|NCT00775437|Secondary|Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 70% Response (PedACR70)|The PedACR70 response is defined by the PedACR as ≥ 70% improvement in at least 3 of 6 JIA core set criteria, and ≥ 30% worsening in not more than 1 of 6 JIA core set criteria. The 6 variables for the JIA core set criteria include PGA of participant's disease activity, Parent's Global Assessment of participant's disease activity, number of active joints (joints with swelling not due to deformity or joints with LOM and joints with POM, tenderness, or both), number of joints with LOM, DICHAQ, and CRP. Baseline is the last value prior to the first dose of study drug. Missing data were imputed up to Week 60 using LOCF and by NRI; observed values are presented for timepoints past Week 60. n=number of participants for either observed or imputed methods at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||percentage of participants|||Number
778817|NCT00775437|Secondary|Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 50% Response (PedACR50)|The PedACR50 response is defined by the PedACR as ≥ 50% improvement in at least 3 of 6 JIA core set criteria, and ≥ 30% worsening in not more than 1 of 6 JIA core set criteria. The 6 variables for the JIA core set criteria include PGA of participant's disease activity, Parent's Global Assessment of participant's disease activity, number of active joints (joints with swelling not due to deformity or joints with LOM and joints with POM, tenderness, or both), number of joints with LOM, DICHAQ, and CRP. Baseline is the last value prior to the first dose of study drug. Missing data were imputed up to Week 60 using LOCF and by NRI; observed values are presented for timepoints past Week 60. n=number of participants for either observed or imputed methods at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||percentage of participants|||Number
778818|NCT00775437|Secondary|Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 30% Response (PedACR30)|The PedACR30 response is defined by the PedACR as ≥30% improvement in at least 3 of 6 JIA core set criteria, and ≥30% worsening in ≤1 of 6 JIA core set criteria. The 6 variables for the JIA core set criteria are Physician's Global Assessment (PGA) of participant's disease activity, Parent's Global Assessment of participant's disease activity, number of active joints (joints with swelling not due to deformity or joints with loss of passive motion [LOM] and joints with pain on passive motion [POM], tenderness, or both), number of joints with LOM, Disability Index of Child Health Assessment Questionnaire (DICHAQ), and C-reactive protein (CRP). Baseline is the last value prior to the first dose of study drug. Missing data were imputed up to Week 60 using last observation carried forward (LOCF) and non-responder imputation (NRI); observed values are presented for timepoints past Week 60. n=number of participants for either observed or imputed methods at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||percentage of participants|||Number
778823|NCT00775437|Secondary|Alkaline Phosphatase (ALP): Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||U/L||Standard Deviation|Mean
778824|NCT00775437|Secondary|Aspartate Aminotransferase (SGOT/AST): Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug.Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||U/L||Standard Deviation|Mean
778825|NCT00775437|Secondary|Alanine Aminotransferase (SGPT/ALT): Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||U/L||Standard Deviation|Mean
778826|NCT00775437|Secondary|Basophils: Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||x10^9/L||Standard Deviation|Mean
778827|NCT00775437|Secondary|Eosinophils: Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||x10^9/L||Standard Deviation|Mean
778828|NCT00775437|Secondary|Monocytes: Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||x10^9/L||Standard Deviation|Mean
778829|NCT00775437|Secondary|Lymphocytes: Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||x10˄9/L||Standard Deviation|Mean
778830|NCT00775437|Secondary|Neutrophils: Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||x10˄9/L||Standard Deviation|Mean
778831|NCT00775437|Secondary|White Blood Cell (WBC) Count: Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||x10^9/L||Standard Deviation|Mean
778832|NCT00775437|Secondary|Platelets: Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||x10˄9/L||Standard Deviation|Mean
778833|NCT00775437|Secondary|Red Blood Cell (RBC) Count: Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||x10˄12/L||Standard Deviation|Mean
778834|NCT00775437|Secondary|Hematocrit: Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||Fraction||Standard Deviation|Mean
778835|NCT00775437|Secondary|Hemoglobin: Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||g/L||Standard Deviation|Mean
778836|NCT00775437|Secondary|Mean Serum Adalimumab Trough Concentrations at Week 0, Week 12, and Week 24|Adalimumab concentrations in serum were determined using a validated enzyme-linked immunoadsorbent assay (ELISA) method. The lower limit of quantitation (LLOQ) for adalimumab is 3.13 ng/mL.|Weeks 0, 12, and 24|All participants who had samples for pharmacokinetic analysis||µg/mL||Standard Deviation|Mean
778837|NCT00775437|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. If an AE meets any of the following criteria, it is considered a serious adverse event (SAE): Results in death, is life-threatening, results in hospitalization or the prolongation of hospitalization, is a congenital anomaly or a persistent or significant disability/incapacity, or is an important medical event requiring medical or surgical intervention to prevent a serious outcome. A treatment-emergent AE (TEAE) is defined as any AE with onset or worsening reported by a participant from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration (total of 32.5 months).|TEAEs were collected from first dose of study drug until 70 days after the last dose of study drug and before start of commercial adalimumab or other biologics (32.5 months).|||participants|||Number
778838|NCT00775450|Secondary|Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine|Seroconversion was defined as either a pre-vaccination hemagglutinin inhibition (HAI) titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre- vaccination titer ≥ 1:10 and a minimum 4 fold increase at 28 days post vaccination.|Day 28 post vaccination|Serum antibody titers were assessed in the per-protocol population.||Percentage of Participants|||Number
778839|NCT00775450|Secondary|Percentage of Participants Who Achieved Seroprotection Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine|Seroprotection was defined as hemagglutinin inhibition (HAI) titer ≥ 1:40 at Day 28.|Days 0 and 28 post-vaccination|Serum antibody titers were assessed in the per-protocol population.||Percentage of Participants|||Number
778840|NCT00775450|Secondary|Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection|Serum antibody titers for the influenza vaccine serogroups A/H1N1, A/H3N2, and B were assessed by the hemagglutinin inhibition (HAI) assay.|Day 0 and Day 28 post-vaccination|Serum antibody titers were assessed in the per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
778841|NCT00775450|Primary|Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection|Solicited injection site reactions: Pain, Erythema (redness), Swelling, Induration, Ecchymosis, Pruritus. Solicited systemic reactions: Fever, (Temperature), Headache, Malaise, Myalgia, and Shivering.|Days 0 through 7 post vaccination|Safety analysis was on all enrolled and vaccinated subjects with available reaction data, intent-to-treat population.||Participants|||Number
778842|NCT00775463|Secondary|Time to Ulcer Healing|A subject was counted as having all ulcers completely healed at the earliest assessment for which all ulcers are designated as “healed” and no new ulcers appeared for the remainder of the trial. The time to complete healing of all ulcers were calculated as the number of days from randomization to the date of these respective assessments, provided that complete healing was achieved during the study.|Week 20|||days||Standard Deviation|Mean
778843|NCT00775463|Secondary|Time to Ulcer Healing- Percentage of Subjects With Complete Healing|A subject was counted as having all ulcers completely healed at the earliest assessment for which all ulcers are designated as “healed” and no new ulcers appeared for the remainder of the trial.|Week 20|||percentage of participants|||Number
778844|NCT00775463|Secondary|Short Form 36|Change in patient quality of life was measured by the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36), a self-administered questionnaire covering eight areas: physical function, physical role, bodily pain, general health, vitality, social function, emotional role, and mental health. For each area, the score range from 0 (poorer health status) to 100 (better health status). The SF-36 is one of the most widely used and validated instruments to assess quality of life in patients with systemic illnesses. A decrease (negative change) in a domain score corresponds to deterioration.|Week 20|The intent to treat population is all subjects that received at least one dose of study drug. Subjects were counted in the assigned group regardless of the actual treatment given. Missing values imputed by carrying last observation forward or assigning value equalling overall poorest relative change. Excluded subjects without a Baseline observation||units on a scale||Inter-Quartile Range|Median
778845|NCT00775463|Secondary|Patient Impression of Change (PIC) Questionnaire|The PIC questionnaire consisted of three Likert items that asked the subject to rate changes in their digital ulcer, Raynaud’s phenomenon and disease status since their last visit on a seven-level scale (very much improved, much improved, somewhat improved, same, somewhat worse, much worse and very much worse).|Week 20|The intent to treat population is all subjects that received at least one dose of study drug. Subjects were counted in the assigned group regardless of the actual treatment given. Missing values imputed by carrying last observation forward or assigning value equalling overall poorest relative change. Excluded subjects without a Baseline observation||participants|||Number
778846|NCT00775463|Secondary|Short-Form McGill Pain Questionnaire|The SF-MPQ assessment has three component scores: the pain rating index (PRI), a pain visual analogue numerical scale (Pain VAS) and the present pain intensity (PPI). PRI is calculated by summing the responses (0=None to 3=Severe) to the 15 questions describing pain during the previous week and rated on an intensity scale as 0= none, 1= mild, 2= moderate or 3= severe and has possible values ranging from 0 to 45. The Pain VAS is a 100 mm VAS on which subjects were asked to rate pain during the previous week with values ranging from no pain (0.0) to worst possible pain (10.0). The PPI rated pain on a 6-point category scale from 0 (no pain) to 5 (excruciating pain).|Week 20|The intent to treat population is all subjects that received at least one dose of study drug. Subjects were counted in the assigned group regardless of the actual treatment given. Missing values imputed by carrying last observation forward or assigning value equalling overall poorest relative change. Excluded subjects without a Baseline observation||units on a scale||Inter-Quartile Range|Median
778847|NCT00775463|Secondary|Modified Rodnan Skin Score (mRSS)|The skin thickening was assessed by the Investigator in 17 body areas: fingers, hands, forearms, arms, feet, legs, and thighs (bilaterally) and face, chest, and abdomen (singly). Each area was scored 0–3; 0 representing normal skin and 3 being severe thickening. The mRSS was the sum of the individual skin assessment scores: possible range of 0-51; 0 (no thickening) to 51 (severe thickening in all 17 areas) .|Week 20|The intent to treat population is all subjects that received at least one dose of study drug. Subjects were counted in the assigned group regardless of the actual treatment given. Missing values imputed by carrying last observation forward or assigning value equalling overall poorest relative change. Excluded subjects without a Baseline observation||units on a scale||Inter-Quartile Range|Median
778848|NCT00775463|Secondary|Scleroderma Health Assessment Questionnaire (SHAQ)|The SHAQ is a patient self-administered instrument which has been previously validated in SSc and demonstrates meaningful clinical changes in the course of the disease over time. It is comprised of a 20 question instrument pertaining to specific activities with possible integer responses of 0 (without any difficulty) to 3 (unable to do), and five additional scleroderma-specific visual analog scale (VAS) domains (Overall Disease Activity, Raynaud’s Phenomenon, Finger Ulcers, Breathing, and Intestinal Problems) with possible values ranging from 0.0 to 15.0. The 20 questions are divided into eight domains. A mean score is calculated for each domain ranging from 0 to 3. A composite HAQ DI score is calculated by dividing the summed domain scores by the number of domains answered. The composite score is reported, falling between 0 and 3 on an ordinal scale. The scores are interpreted as 0 (no impairment in function) to 3 (maximal impairment of function).|Week 20|The intent to treat population is all subjects that received at least one dose of study drug. Subjects were counted in the assigned group regardless of the actual treatment given. Missing values imputed by carrying last observation forward or assigning value equalling overall poorest relative change. Excluded subjects without a Baseline observation||units on a scale||Inter-Quartile Range|Median
778849|NCT00775463|Secondary|Cochin Hand Function Scale (CHFS)|The CHFS has been demonstrated as a reliable and valid assessment of hand function at the activity level in persons with SSc. It is comprised of 18 questions with possible integer responses of 0 (without difficulty) to 5 (impossible). The CHFS Score is simply the sum of all 18 questions, divided by the number of questions actually answered, multiplied by 18. At least 10 of the 18 questions must have been answered in order for CHFS to be calculated. Therefore, CHFS Score values can range from 0 (least limitation) to 90 (most limitation). A higher score indicates more difficulty in hand function or greater disability.|Week 20|The intent to treat population is all subjects that received at least one dose of study drug. Subjects were counted in the assigned group regardless of the actual treatment given. Missing values imputed by carrying last observation forward or assigning value equalling overall poorest relative change. Excluded subjects without a Baseline observation||units on a scale||95% Confidence Interval|Median
778850|NCT00775463|Secondary|Physician Global Assessment of Digital Ulcer Severity VAS|"Physicians rated their global impression of digital ulcer severity on a 15-cm VAS from scaled 0 (no disease activity) to 100 (very severe disease).
The term “severity” was used to measure the extent of disease activity and associated disability or discomfort the patient experienced during the indicated time period."|Week 20|The intent to treat population is all subjects that received at least one dose of study drug. Subjects were counted in the assigned group regardless of the actual treatment given. Missing values imputed by carrying last observation forward or assigning value equalling overall poorest relative change. Excluded subjects without a Baseline observation||units on a scale||Inter-Quartile Range|Median
778851|NCT00775463|Secondary|Patient Global Assessment of Digital Ulcer Severity VAS|"Patients rated their global impression of digital ulcer severity on a 15-cm VAS from scaled 0 (no disease activity) to 100 (very severe disease).
The term “severity” was used to measure the extent of disease activity and associated disability or discomfort the patient experienced during the indicated time period."|Week 20|The intent to treat population is all subjects that received at least one dose of study drug. Subjects were counted in the assigned group regardless of the actual treatment given. Missing values imputed by carrying last observation forward or assigning value equalling overall poorest relative change. Excluded subjects without a Baseline observation||units on a scale||Inter-Quartile Range|Median
778852|NCT00775463|Secondary|Digital Ulcer Pain VAS|Digital ulcer pain was rated on a 100-mm VAS on which subjects were asked to rate their average overall hand pain during the last week. The recorded value was divided by 10, with values ranging from 0.0 (no pain) to 10.0 (unbearable pain), expressed to one decimal.|Week 20|The intent to treat population is all subjects that received at least one dose of study drug. Subjects were counted in the assigned group regardless of the actual treatment given. Missing values imputed by carrying last observation forward or assigning value equalling overall poorest relative change. Excluded subjects without a Baseline observation||units on a scale||Inter-Quartile Range|Median
778853|NCT00775463|Primary|Net Ulcer Burden|Net ulcer burden was defined as the number of “new” or “active” digital ulcers (DU), plus the number of “indeterminate” DUs at that assessment that have previously been classified as either “active” or “new” at any earlier assessment during the study. A DU was defined as an area with visually discernable depth and a loss of continuity of epithelial coverage, which could be denuded or covered by a scab or necrotic tissue. If denuded, the DU was pronounced “active.” If denudation could not be judged because of the presence of scab or necrotic tissue, DU presenting with features, including underlying pain, based on Investigator clinical judgment to be consistent with loss of epithelialization, epidermis, or dermis, and requiring treatment were designated as “active.” Otherwise, the DU was pronounced “indeterminate.” Only DUs distal to the proximal interphalangeal joints, volar to the equator of the finger, not localized in creases and vascular in origin were assessed.|Week 20|The intent to treat population is all subjects that received at least one dose of study drug. Subjects were counted in the assigned group regardless of the actual treatment given. Missing values imputed by carrying last observation forward or assigning value equalling overall poorest relative change.||ulcers||Inter-Quartile Range|Median
778854|NCT00775528|Primary|Number of Patients With at Least One Treatment Emergent Adverse Event (TEAE)|Treatment Emergent Adverse Events are defined as adverse events started at or after the first administration of study drug and include those events started prior to the first administration but which worsened after the first intake.|10 Days|||Participants|||Number
778855|NCT00775528|Secondary|Total Calorie Intake (kcal)|The total calorie intake was determined as the average of total calorie of daily food intake intake over a 3-day period.|Last 3 days in a 10-day treatment period|The efficacy results are presented on the Full Analysis Set meaning patients having taken the study drug and with Post-baseline efficacy data.||Kcal||Standard Deviation|Mean
778856|NCT00775528|Secondary|Fat Intake (g)|The mean daily fat intake was determined as the average of daily fat intake over a 3-day period.|Last 3 days in a 10-day treatment period|The efficacy results are presented on the Full Analysis Set meaning patients having taken the study drug and with Post-baseline efficacy data.||Grams||Standard Deviation|Mean
778857|NCT00775528|Secondary|Stool Fat (% Fat)|The stool fat content was calculated as percent fat of dry solid weight per bowel movement. Stool fat per patient was derived as mean over three bowel movements sampled (i.e. one sample per day).|Last 3 days in a 10-day treatment period|The efficacy results are presented on the Full Analysis Set meaning patients having taken the study drug and with Post-baseline efficacy data.||Percentage of fat||Standard Deviation|Mean
778858|NCT00775593|Secondary|Duration of Survival||At 2 years from study entry|||months||Full Range|Median
778859|NCT00775593|Secondary|Duration of Response|Participants who responded to treatment|At 2 years from study entry|||months||Standard Deviation|Mean
778860|NCT00775593|Secondary|Number of Serious Adverse Events Within 2 Years||At 2 years from study entry|||serious adverse events|||Number
778861|NCT00775593|Primary|Complete Response Rate||At 2 years from study entry|||participants|||Number
778862|NCT00775606|Secondary|Response to Immunization With Pneumococcus Polysaccharide and Tetanus-diphtheria Vaccines|Response to immunization with pneumococcus polysaccharide and tetanus-diphtheria vaccines was not done due to small sample size|4 weeks after treatment initiation||||||
778863|NCT00775606|Secondary|Activated and Regulatory CD4+ and CD8+ T-cell Frequencies||4, 12 and 24 weeks after treatment initiation||||||
778864|NCT00775606|Secondary|Naive, Central Memory and Effector Memory CD4+ and CD8+ (Cluster of Differentiation 8) T-cell Frequency||4, 12 and 24 weeks after treatment initiation||||||
778866|NCT00775606|Primary|CD4+ (Cluster of Differentiation 4) T-cell Apoptosis|Change in the percentage of naive CD4 T-cells undergoing apoptosis as measured by propidium iodide staining. This is a lab test that measures the percentage of naive CD4 T-cells that are undergoing cell death. The change in this measure is obtained by determining the difference between the percentage of naive CD4 T-cells undergoing apoptosis at week 24 of treatment and the percentage undergoing apoptosis at baseline.|24 weeks from treatment initiation (baseline and week 24)|||per cent||Standard Deviation|Mean
778867|NCT00775645|Other Pre-specified|Association Between Genetic Markers Responsible for Taxane Metabolism and Clearance and the Degree of Neuropathy|Explore the relationship between genetic markers responsible for taxane metabolism and clearance (e.g., CYP2C8, CYP3A4, CYP3A5, GSTM1, and GSTP1) and the degree of neuropathy in these patients.|12 weeks post-registration|Data still in process; Analysis to be performed in future.|||||
778868|NCT00775645|Other Pre-specified|Association Between Nerve Growth Factor Levels and the Degree of Neuropathy and Functional Status|Explore the relationship between nerve growth factor levels and the degree of neuropathy and functional status in these patients.|12 weeks post-registration|Data still in process; Analysis to be performed in future.|||||
778869|NCT00775645|Other Pre-specified|Treatment and Concurrent Therapy|total dose of taxane received and treatment delays, compliance with therapy, and use of concurrent medications, dietary supplements (e.g., glutamine), vitamin E, and complementary and alternative medicines|12 weeks post-registration|Data still in process; Analysis to be performed in future.|||||
778870|NCT00775645|Other Pre-specified|Serum Nerve Growth Factor Levels||12 weeks post-registration|Data still in process; Analysis to be performed in future.|||||
778871|NCT00775645|Other Pre-specified|Proportion of Patients Experiencing Grade 3 or 4 Neuropathy|Proportion of patients experiencing grade 3 or 4 neuropathy|12 weeks post-registration|||Participants|||Count of Participants
778872|NCT00775645|Secondary|12-week FACIT-fatigue Model-adjusted Score in ALC and Placebo Groups|Compare fatigue outcome between treatment and placebo groups as measured by the 13-item Functional Assessment of Chronic Illness Therapy FACIT-fatigue questionnaire at 12 weeks after study registration in women with breast cancer undergoing adjuvant taxane-based chemotherapy. Linear regression model adjusted for baseline score, taxane regiment, and age. Lower scores indicate more fatigue. Total possible range is 0 to 52. For more information on this subscale, please see http://www.facit.org/FACITOrg/Questionnaires|12 weeks post-registration|||FACIT-fatigue score||Full Range|Mean
778873|NCT00775645|Secondary|12-week FACT-Trial Outcome Index(TOI) Functional Status Model-adjusted Score in ALC and Placebo Groups|Compare FACT-TOI outcome in treatment vs placebo groups at 12 weeks after study registration in women with breast cancer undergoing adjuvant taxane-based chemotherapy. Linear regression model adjusted for baseline score, taxane regiment, and age. Lower scores indicate worse functional status. Total possible range is 0 to 120. For more information on this subscale, please see http://www.facit.org/FACITOrg/Questionnaires|12 weeks post-registration|||units on a scale||Full Range|Mean
778874|NCT00775645|Primary|12-week FACT-Taxane Neurotoxicity Model-adjusted Score in ALC and Placebo Groups|Compare whether treatment with acetyl-L-carnitine hydrochloride vs placebo prevents symptoms of neuropathy as measured by the 11-item neurotoxicity (NTX) component of the Functional Assesment of Cancer Therapy (FACT)-Taxane Questionnaire at 12 weeks after study registration in women with breast cancer undergoing adjuvant taxane-based chemotherapy. Linear regression model adjusted for baseline score, taxane regiment, and age. Lower scores indicate worse CIPN. Total possible range is 0 to 64. For more information on this subscale, please see http://www.facit.org/FACITOrg/Questionnaires|12 weeks post-registration|||units on a scale||Full Range|Mean
778875|NCT00775658|Primary|The Difference in Area (cm2) of the Flare Size in Histamine Skin Test Response During Treatment With Olopatadine Compared to Placebo.||at baseline and at return visit (between study day 7-10)|Sample size determined that 18 participants would provide 80% power to detect a 20% difference with a significance level of 0.05.||cm2||Standard Deviation|Mean
778876|NCT00775658|Primary|The Difference in Area (cm2) of the Wheal Size in Histamine Skin Test Response During Treatment With Olopatadine Compared to Placebo.||at baseline and at return visit (between study day 7-10)|||cm2||Standard Deviation|Mean
778877|NCT00775671|Primary|Marker of Fibrinolysis|Concentration of plasminogen activator inhibitor 1 (PAI-1)antigen.|After 12 weeks of study drug|||ng/mL||Standard Deviation|Mean
778878|NCT00775671|Secondary|Measurement of Insulin Sensitivity|The change in insulin sensitivity index, from baseline to after 12 weeks of treatment. Calculated from the intravenous glucose tolerance test at baseline and at 12 weeks.|3 hours|||10-4xmin-1 per mU/L||Standard Deviation|Mean
778879|NCT00783094|Secondary|Change From Baseline in Postvoid Residual Volume (PVR) at 54-Week Endpoint|Post residual volume (PVR) is measured by ultrasound at regular intervals.|Baseline, 54 weeks|All participants enrolled in the open-label extension who received at least 1 dose of tadalafil.||milliliter||Standard Deviation|Mean
778880|NCT00783094|Secondary|Change From Baseline in Prostate Specific Antigen (PSA) at 54-Week Endpoint|Measurement of nanograms of PSA per milliliter (ng/mL) of blood.|Baseline, 54 weeks|All participants enrolled in the open-label extension who received at least 1 dose of tadalafil.||microgram/liter||Standard Deviation|Mean
778881|NCT00783094|Secondary|Change From Baseline in Sitting Heart Rate at 54-Week Endpoint||Baseline, 54-weeks|All participants enrolled in the open-label extension who received at least 1 dose of tadalafil.||beats per minute (bpm)||Standard Deviation|Mean
778882|NCT00783094|Secondary|Change From Baseline in Blood Pressure During at 54-Week Endpoint||Baseline, 54 weeks|All participants enrolled in the open-label extension who received at least 1 dose of tadalafil.||millimeters of mercury (mmHg)||Standard Deviation|Mean
778883|NCT00783094|Secondary|Number of Participants With Adverse Events During 42 Weeks of Open-Label Treatment|A listing of Adverse Events are reported in the Reported Adverse Event Section.|End of 12 weeks of double-blind through 54 weeks|All participants enrolled in the open-label extension who received at least 1 dose of tadalafil.||participants|||Number
778884|NCT00783094|Secondary|Change From Baseline in Uroflowmetry Parameter: Peak Flow Rate (Qmax) at 54-Week Endpoint|Uroflowmetry was assessed by Qmax, defined as the peak urine flow rate (measured in mL/second using a standard calibrated flowmeter).|Baseline, 54 weeks|All participants enrolled in the open-label extension who received at least 1 dose of tadalafil.||units on a scale||Standard Deviation|Mean
791697|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Aspartate Aminotransferase [AST])||Baseline up to Month 7|||percentage of participants|||Number
778885|NCT00783094|Secondary|Change From Baseline in Overactive Bladder Symptom Score (OABSS) at 54-Week Endpoint|The OABSS is a four-symptom questionnaire to assess overactive bladder (OAB) symptoms: daytime frequency, nighttime frequency, urgency, and urgency incontinence. Scores range from 0 - 15, with higher scores indicating more severe OAB symptoms.|Baseline, 54 weeks|All participants enrolled in the open-label extension who received at least 1 dose of tadalafil.||units on a scale||Standard Deviation|Mean
778886|NCT00783094|Secondary|Change From Baseline in IPSS Quality of Life (QoL) Index at 54-Week Endpoint|Assessment of quality of life (QOL) by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible).|Baseline, 54 weeks|All participants enrolled in the open-label extension who received at least 1 dose of tadalafil.||units on a scale||Standard Deviation|Mean
778887|NCT00783094|Secondary|Change From Baseline in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore at 54-Week Endpoint|IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 0 (not at all) to 5 (frequent obstructive symptoms), thus the 4 questions of the obstructive score range from 0 to 20.|Baseline, 54 weeks|All participants enrolled in the open-label phase who received at least 1 dose of tadalafil.||units on a scale||Standard Deviation|Mean
778888|NCT00783094|Secondary|Change From Baseline in International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore at 54-Week Endpoint|IPSS storage (irritative) subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. Scores range from 0 (not at all) to 5 (frequent irritative symptoms), thus the 3 questions of the irritative subscore range from 0 to 15.|Baseline, 54 weeks|All participants enrolled in the open-label extension period who received at least 1 dose of tadalafil.||units on a scale||Standard Deviation|Mean
778889|NCT00783094|Secondary|Change From Baseline in the International Prostate Symptom Score (IPSS) Total Score at 54-Week Endpoint|The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.|Baseline, 54 weeks|All participants enrolled in the open-label extension period who received at least 1 dose of tadalafil.||units on a scale||Standard Deviation|Mean
778890|NCT00783094|Secondary|Change From Baseline in Prostate Specific Antigen (PSA) at 12-Week Endpoint|Measurement of nanograms of PSA per milliliter (ng/mL) of blood.|Baseline, 12 weeks|Safety Analysis Set: All randomized participants who received study treatment grouped by the treatment actually taken.||Micrograms per liter||Standard Deviation|Mean
778891|NCT00783094|Secondary|Change From Baseline in Postvoid Residual Volume (PVR) at 12-Week Endpoint|Postvoid residual volume (PVR) is measured by ultrasound at regular intervals.|Baseline, 12 weeks|Safety Analysis Set: all randomized participants who received study treatment grouped by the treatment actually taken.||milliliters||Standard Deviation|Mean
778892|NCT00783094|Secondary|Change From Baseline in Sitting Heart Rate at 12-Week Endpoint||Baseline, 12 Weeks|Safety Analysis Set: all randomized participants who received study treatment grouped by the treatment actually taken.||beats per minute||Standard Deviation|Mean
778893|NCT00783094|Secondary|Change From Baseline in Blood Pressure at 12-Week Endpoint||Baseline, 12 weeks|Safety Analysis Set: all randomized participants who received study treatment grouped by the treatment actually taken.||mmHg||Standard Deviation|Mean
778894|NCT00783094|Secondary|Number of Participants With Adverse Events During 12 Weeks of the Study|A listing of Adverse Events are reported in the Reported Adverse Event Section.|Baseline through 12 weeks|All randomized participants||participants|||Number
778895|NCT00783094|Secondary|Tadalafil Pharmacokinetics in Japanese Men: Plasma Concentration Measurement|Plasma from participants in the tadalafil treatment groups were assayed using a validated liquid chromatographic/mass spectrometric (LC/MS) method.|Baseline, 12 weeks|Participants who received 2.5 mg or 5 mg tadalafil once daily during the double-blind period.||nanogram/milliliter||Standard Deviation|Geometric Mean
778896|NCT00783094|Secondary|Change From Baseline in Uroflowmetry Parameter: Peak Flow Rate (Qmax) at 12-Week Endpoint|Uroflowmetry was assessed by Qmax, defined as the peak urine flow rate (measured in mL/second using a standard calibrated flowmeter).|Baseline, 12 weeks|Participants in the Full Analysis Set (FAS): participants who were randomized and started study medication.||milliliters per second||Standard Error|Least Squares Mean
778897|NCT00783094|Secondary|Change From Baseline in Overactive Bladder Symptom Score (OABSS) at 12-Week Endpoint|The OABSS is a four-symptom questionnaire to assess overactive bladder (OAB) symptoms: daytime frequency, nighttime frequency, urgency, and urgency incontinence. Scores range from 0 - 15, with higher scores indicating more severe OAB symptoms.|Baseline, 12 weeks|Participants in the Full Analysis Set (FAS): participants who were randomized and started study medication.||units on a scale||Standard Error|Least Squares Mean
778898|NCT00783094|Secondary|Change From Baseline in IPSS Quality of Life (QoL) Index at 12-Week Endpoint|Assessment of quality of life (QOL) by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible).|Baseline, 12 weeks|Participants in the Full Analysis Set (FAS): participants who were randomized and started study medication.||units on a scale||Standard Error|Least Squares Mean
778899|NCT00783094|Secondary|Change From Baseline in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore at 12-Week Endpoint|IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 0 (not at all) to 5 (frequent obstructive symptoms), thus the 4 questions of the obstructive score range from 0 to 20.|Baseline, 12 weeks|Participants in the Full Analysis Set (FAS): participants who were randomized and started study medication.||units on a scale||Standard Error|Least Squares Mean
778900|NCT00783094|Secondary|Change From Baseline in International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore at 12-Week Endpoint|IPSS storage (irritative) subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. Scores range from 0 (not at all) to 5 (frequent irritative symptoms), thus the 3 questions of the irritative subscore range from 0 to 15.|Baseline, 12 weeks|Participants in the Full Analysis Set (FAS): participants who were randomized and started study medication.||units on a scale||Standard Error|Least Squares Mean
778901|NCT00783094|Primary|Change From Baseline in International Prostate Symptom Score (IPSS) Total Score at 12-Week Endpoint|The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.|Baseline, 12 weeks|Participants in the Full Analysis Set (FAS): participants who were randomized and started study medication.||units on a scale||Standard Error|Least Squares Mean
778902|NCT00783198|Secondary|Average Rhinoconjunctivitis DMS for the Peak RS|Rhinoconjunctivitis DMS was based on participant use of specific study-provided rescue medicationwith different rescue medications being assigned different scores/dose unit. The maximum rhinoconjunctivitis DMS score was 36, with a lower score indicating less rhinoconjuntivitis medication use. Raw means for DMS were converted to adjusted means based on an ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects.|The 15-day period during the ragweed season with the highest moving pollen average|The FAS population consisted of all randomized participants who took at least one dose of study medication and had at least one post-randomization efficacy measurement. A total of 5 participants at one site were excluded from all efficacy analyses due to GCP issues.||score on a scale||Standard Error|Mean
778903|NCT00783198|Secondary|Average Rhinoconjunctivitis DSS for the Entire RS|The rhinoconjunctivitis DSS consisted of a total of 6 symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes and watery eyes) that were measured on a scale of 0 to 3 (0=no symptoms, 3=severe symptoms; score range: 0-18), with a lower score indicating less rhinoconjuntivitis symptoms. Raw means for DSS were converted to adjusted means based on an ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects.|Approximately 5 weeks|The FAS population consisted of all randomized participants who took at least one dose of study medication and had at least one post-randomization efficacy measurement. A total of 5 participants at one site were excluded from all efficacy analyses due to GCP issues.||score on a scale||Standard Error|Mean
778904|NCT00783198|Secondary|Average Rhinoconjunctivitis DSS for the Peak RS|The rhinoconjunctivitis DSS consisted of a total of 6 symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes and watery eyes) that were measured on a scale of 0 to 3 (0=no symptoms, 3=severe symptoms; score range: 0-18), with a lower score indicating less rhinoconjuntivitis symptoms. Raw means for DSS were converted to adjusted means based on an ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects.|The 15-day period during the ragweed season with the highest moving pollen average|The FAS population consisted of all randomized participants who took at least one dose of study medication and had at least one post-randomization efficacy measurement. A total of 5 participants at one site were excluded from all efficacy analyses due to GCP issues.||score on a scale||Standard Error|Mean
778905|NCT00783198|Secondary|Average Combined Rhinoconjunctivitis DSS and DMS Over the Entire RS|The total combined score is a composite endpoint that combines the rhinoconjuntivitis DSS and the rhinoconjunctivitis DMS. The rhinoconjunctivitis DSS consisted of a total of 6 symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes and watery eyes) that were measured on a scale of 0 to 3 (0=no symptoms, 3=severe symptoms; score range: 0-18). Rhinoconjunctivitis DMS was based on participant use of specific study-provided rescue medicationwith different rescue medications being assigned different scores/dose unit. The maximum rhinoconjunctivitis DMS score was 36. The sum of the rhinoconjunctivitis DSS and DMS could range from 0 to 54, with a lower score indicating less rhinoconjuntivitis symptoms and medication use. Raw means for DSS+DMS were converted to adjusted means based on an ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects.|Approximately 5 weeks|The FAS population consisted of all randomized participants who took at least one dose of study medication and had at least one post-randomization efficacy measurement. A total of 5 participants at one site were excluded from all efficacy analyses due to GCP issues.||score on a scale||Standard Error|Mean
778906|NCT00783198|Primary|Combined (Sum of) Rhinoconjunctivitis Daily Symptom Score (DSS) and Daily Medication Score (DMS) Averaged Over the Peak Ragweed Season (RS)|The total combined score is a composite endpoint that combines the rhinoconjuntivitis DSS and the rhinoconjunctivitis DMS. The rhinoconjunctivitis DSS consisted of a total of 6 symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes and watery eyes) that were measured on a scale of 0 to 3 (0=no symptoms, 3=severe symptoms; score range: 0-18). Rhinoconjunctivitis DMS was based on participant use of specific study-provided rescue medicationwith different rescue medications being assigned different scores/dose unit. The maximum rhinoconjunctivitis DMS score was 36. The sum of the rhinoconjunctivitis DSS and DMS could range from 0 to 54, with a lower score indicating less rhinoconjuntivitis symptoms and medication use. Raw means for DSS+DMS were converted to adjusted means based on an analysis of variance (ANOVA) model with baseline asthmatic condition, pollen region and treatment group as fixed effects.|The 15-day period during the ragweed season with the highest moving pollen average|The Full Analysis Set (FAS) population consisted of all randomized participants who took at least one dose of study medication and had at least one post-randomization efficacy measurement. A total of 5 participants at one site were excluded from all efficacy analyses due to Good Clinical Practice (GCP) issues.||score on a scale||Standard Error|Mean
778907|NCT00783224|Primary|Change in 4 Nasal Symptom Score (Sneezing Attack, Rhinorrhea, Nasal Congestion, and Nasal Itching) After 2 Weeks|The nasal symptoms (sneezing attacks, rhinorrhea, nasal congestion and itching) were rated in 4 grades (+++: 3 points, ++: 2 points, +: 1 point, -: 0 point) based on the evaluation criteria for nasal symptoms. Total possible best score is 0 points, total possible worst score is 12 points.|Baseline to 2 weeks of treatment|||Units on a scale||Standard Error|Least Squares Mean
778915|NCT00783302|Secondary|Summary of Subjects Developing 1 or More Positive and Negative Cardiac Clinical Outcomes at 1 Month, 6 Months, and 12 Months After Undergoing Coronary Computed Tomography Angiography (CCTA) Examination Using Visipaque.|"The number of subjects in the efficacy population developing 1 or more positive and negative cardiac clinical outcomes at 1 month, 6 months, and 12 months after undergoing a Coronary Computed Tomography Angiography (CCTA) examination using Visipaque. Clinical outcomes are independent of any serious adverse events and adverse events associated with the drug administration.
This outcome measure is not reporting those subjects with serious adverse events and adverse events associated with the drug administration."|Within 1 month, 6 months and 12 months post contrast administration.|||Number of Subjects|||Number
778916|NCT00783302|Primary|The Negative Predictive Value (NPV) of Visipaque-enhanced Coronary Computed Tomography Angiography (CCTA) for Ruling Out Downstream Cardiovascular Events at Each Follow-up Period When Compared to the Standard of Truth (SoT).|Statistical analysis of the Negative Predictive Value (NPV) of Visipaque-enhanced CCTA for ruling out downstream cardiovascular events at each follow-up period when compared to the SoT.The results are calculated as percentage of participants.|Within 1 month, 6 months and 12 months post contrast administration.|||Percentage of Subjects||95% Confidence Interval|Number
778917|NCT00783302|Primary|The Specificity of Visipaque-enhanced Coronary Computed Tomography Angiography (CCTA) for Ruling Out Downstream Cardiovascular Events at Each Follow-up Period When Compared to the Standard of Truth (SoT).|Statistical analysis of the Specificity of Visipaque-enhanced CCTA for ruling out downstream cardiovascular events at each follow-up period when compared to the SoT.The results are calculated as percentage of participants.|Within 1 month, 6 months and 12 months post contrast administration.|||Percentage of Subjects||95% Confidence Interval|Number
778918|NCT00783302|Primary|The Positive Predictive Value (PPV) of Visipaque-enhanced Coronary Computed Tomography Angiography (CCTA) for Ruling Out Downstream Cardiovascular Events at Each Follow-up Period When Compared to the Standard of Truth (SoT).|Statistical analysis of the Positive Predictive Value (PPV) of Visipaque-enhanced CCTA for predicting downstream cardiovascular events at each follow-up period when compared to the SoT.The results are calculated as percentage of participants.|Within 1 month, 6 months and 12 months post contrast administration.|||Percentage of Subjects||95% Confidence Interval|Number
778919|NCT00783302|Primary|The Sensitivity of Visipaque-enhanced Coronary Computed Tomography Angiography (CCTA) for Predicting Downstream Cardiovascular Events at Each Follow-up Period When Compared to the Standard of Truth (SoT).|Statistical analysis of the Sensitivity of Visipaque-enhanced CCTA for predicting downstream cardiovascular events at each follow-up period when compared to the SoT. The results are calculated as percentage of participants.|Within 1 month, 6 months and 12 months post contrast administration.|The subject follow-up period went from 1 month, 6 months and 12 months.||Percentage of Subjects||95% Confidence Interval|Number
778920|NCT00785291|Secondary|Overall Survival|Overall survival was measured as the interval from study entry until death, from any cause, or last contact. Distribution was estimated using the Kaplan Meier product-limit method.|Time from randomization to death or last follow-up (up to 5 years)|||months||95% Confidence Interval|Median
778921|NCT00785291|Secondary|12 Month Progression Free Survival|Percentage of participants who were alive and progression free at 12 months. The 12 month progression free survival, with 95% confidence interval, was estimated using the Kaplan Meier method.|12 months|Participants who never began protocol treatment were excluded.||percentage of participants||95% Confidence Interval|Number
778922|NCT00785291|Secondary|Time to Treatment Failure|Time from registration until treatment failure, defined as early termination of protocol therapy for any reason, first disease progression or death without progression. Surviving participants who were failure free were censored as date last known alive and failure free. Distribution was estimated using the Kaplan Meier product-limit method.|Time from randomization until progression, death, or yearly termination of protocol therapy (up to 5 years)|Participants who never began protocol treatment were excluded.||months||95% Confidence Interval|Median
778923|NCT00785291|Secondary|Objective Tumor Response Rate|Response was defined by the Response Evaluation Criteria in Solid Tumors (RECIST). A responding participant had either a Complete Response (disappearance of all target lesions) or Partial Response (30% decrease in sum of longest diameter of target lesions).|Up to 5 years|||percentage of participants|||Number
779018|NCT00786565|Primary|Low Contrast Uncorrected Visual Acuity Following Cataract Surgery|Low contrast uncorrected visual acuity 3 months post cataract surgery|3 months|Full analysis set, all randomized participants who had cataract surgery one intraocular lens (IOL) in each eye, and who had at least one baseline value and one post-baseline value for efficacy||LogMAR||Standard Deviation|Mean
778924|NCT00785291|Primary|Progression Free Survival|Progression-free survival (PFS) is defined as the interval from registration until first disease progression, regardless of site, or death resulting from any cause, which ever occurred first. Distribution was estimated using the Kaplan Meier product-limit method. Progression is defined as a 20% increase in the sum of longest diameter of target lesions (per Response Evaluation Criteria in Solid Tumors [RECIST] criteria).|Time from randomization to progression or death due to any cause, whichever occurs first (up to 5 years)|Participants who never began protocol treatment were excluded.||months||95% Confidence Interval|Median
778925|NCT00785356|Primary|The Comparison Between the 50 mg Proellex® Dose Level and Placebo in the Change in Hemoglobin From Baseline to 3 Months.||3 months||||||
778926|NCT00785486|Primary|The Area Under the the Concentration Time Curve From Zero to Tau (0-8hrs) for Qualaquin (Quinine) AUC Tau Before and After Midazolam|Qualaquin (quinine) - AUC tau alone at steady state (day 9) and in the presence of coadministered midazolam 2 mg (day 10) over the dosing interval (0 – 8 hours), as calculated by the linear trapezoidal method.|Days 9 and 10 at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, and 7.917 hours|per protocol||ng•h/mL||Standard Deviation|Mean
778927|NCT00785486|Primary|Area Under the Concentration Time Curve From Zero to Infinity (AUC Inf) for Midazolam and 1 Hydroxy Midazolam Before (Day 1) and After (Day 10) Qualaquin (Quinine).|AUC inf for Midazolam and hydroxy-midazolam on day 1 (midazolam alone) and day 10 (midazolam with steady state Qualaquin(quinine)- the sum of AUC0-t plus the ratio of the last measured plasma concentration to the elimination rate constant to determine whether a significant drug interaction occurs between midazolam and quinine|Days 1 and 10 at 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 7.917, 12, 15 and 24 hours|per protocol||ng·h/mL||Standard Deviation|Mean
778928|NCT00785486|Primary|Area Under the Concentration Time Curve From Zero to T (AUC 0-t) for Midazolam and 1-hydroxy Midazolam at Baseline and With Qualaquin (Quinine) at Steady State.|Area under the concentration time curve(AUC 0-t) calculated by the linear trapezoidal method from time 0 to 24 hours, for Midazolam and 1-hydroxy-midazolam on day 1 (midazolam alone) and day 10 (midazolam with Qualaquin -(quinine) at steady state to determine if a significant drug interaction occurs between midazolam and quinine|Days 1 and 10 at 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 7.917, 12, 15 and 24 hours|by protocol||ng•h/mL||Standard Deviation|Mean
778929|NCT00785486|Primary|Maximum Serum Concentration (Cmax)|Maximum serum concentration(Cmax)|Day 1 (Midazolam Alone), Day 9 (Qualaquin (quinine) Alone), Day 10 Midazolam with Qualaquin (quinine)|per protocol||ng/ml||Standard Deviation|Mean
778930|NCT00785512|Secondary|Trough Sitting Systolic Blood Pressure|Change from baseline, week 0 (Visit 9) to Week 4 (Visit 12) in peripheral systolic blood pressure measured at drug trough.|From baseline, week 0 (Visit 9) to week 4 (Visit 12)|||mm HG||Standard Deviation|Mean
778931|NCT00785512|Primary|Trough Sitting Diastolic Blood Pressure|Change from baseline, week 0 (Visit 9) to Week 4 (Visit 12) in peripheral diastolic blood pressure measured at drug trough.|From baseline, week 0 (Visit 9) to week 4 (Visit 12)|||mm HG||Standard Deviation|Mean
778932|NCT00785577|Secondary|Number of Participants With Neurological Treatment Emergent Adverse Events (TEAEs)|"The total number of TEAEs (serious and non-serious) that first occurred or worsened during the treatment period) from the Nervous system disorders system organ class was summarized. A listing of serious AEs (SAEs) and other non-serious AEs is located in the Reported Adverse Event module."|Baseline through 5 weeks|The safety analysis population included all 273 participants randomized to study drug.||participants|||Number
778933|NCT00785577|Secondary|Time to Response|Time to response=first visit achieving a 30% reduction of weekly mean 24-hour APS score. Data were recorded daily (preferably at bedtime) on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The number of days at which 50% of the participants at risk had at least 30% response was reported.|Baseline through 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.||time (days)|||Number
778934|NCT00785577|Secondary|Pharmacokinetic (PK) Parameter: Clearance of LY545694 (CLp) and Compound 645838 (CLm)|Clearance is the volume of plasma cleared of study drug LY545694 (CLp) and metabolite compound 645838 (CLm) per unit time. The original PK/pharmacodynamic (PD) relationship outcome measure analysis was not conducted; therefore, only PK data were reported.|Baseline through 5 weeks|The PK dataset for population modeling consisted of quantifiable plasma LY545694 and Compound 64538 concentrations from participants following daily oral doses of LY545694 21 mg to LY545694 105 mg.||Liters per hour (L/hr)||95% Confidence Interval|Geometric Mean
778935|NCT00785577|Secondary|Number of Participants Reporting Blurry or Hazy Vision Using the Subjective Vision Inventory (SVI) Question 1 (Q1) at 5 Weeks|This scale first asked if the participant was experiencing hazy or blurry vision or if he/she had difficulty focusing. If the answer was yes, follow-up questions rated the degree to which the issue impaired his/her ability to do work or to read.|Week 5|The analysis population was a modified intent to treat (ITT) population defined as participants who received either study drug with only postbaseline data collected.||participants|||Number
778936|NCT00785577|Secondary|Number of Participants With Suicidal Behaviors and Ideations|"The Columbia Suicide Severity Rating Scale (C-SSRS) captured occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors and ideations were provided. Suicidal behavior = a yes answer to any 1 of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation = a yes answer to any 1 of 5 suicidal ideation questions, which included the wish to be dead and 4 different categories of active suicidal ideation."|Baseline through week 5|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.||participants|||Number
778956|NCT00785577|Secondary|Change From Baseline in Weekly Mean Night Pain Severity Score at 5 Weeks|This scale measured night pain APS scores. Data were recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.||units on a scale||Standard Error|Least Squares Mean
791698|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Alanine Aminotransferase [ALT])||Baseline up to Month 7|||percentage of participants|||Number
778937|NCT00785577|Secondary|Change From Baseline in Overall Total Quick Inventory of Depressive Symptomatology (QIDS) Score|The QIDS was a 16-item patient-rated measure of depressive symptomatology. Each item had a 0 to 3 point scale. The total score ranged from 0 to 27 with higher scores indicative of greater severity. QIDS was calculated by summing the scores from the 9 symptom domains of the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) major depressive disorder criteria: depressed mood, loss of interest or pleasure, concentration/decision making, self outlook, suicidal ideation, energy/fatigability, sleep, weight/appetite change, and psychomotor changes.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.||units on a scale||Standard Error|Least Squares Mean
778938|NCT00785577|Secondary|Percentage of Participants With Reported Hypoglycemic Events|"Percentage of participants who reported hypoglycemic (lower than normal level of blood glucose) episodes was summarized as other non-serious adverse events (AEs) from the Investigations system organ class (preferred term = hypoglycemia). A listing of AEs is located in the Reported Adverse Event module."|Baseline through 5 weeks|The safety analysis population included all 273 participants randomized to study drug.||percentage of participants|||Number
778939|NCT00785577|Secondary|Number of Participants With Electrocardiogram Change in Heart Rate Using Bazett's (QTcB) and Fridericia's (QTcF) Formulas|The number of participants having QTcF and QTcB change ≥ 30 msec was summarized.|Baseline through 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.||participants|||Number
778940|NCT00785577|Secondary|Change From Baseline in Vital Signs: Pulse Rate at 5 Weeks|Pulse rate was measured in beats per minute (bpm). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.||beats per minute (bpm)||Standard Error|Least Squares Mean
778941|NCT00785577|Secondary|Change From Baseline in Vital Signs: Systolic Blood Pressure and Diastolic Blood Pressure at 5 Weeks|Participants' systolic blood pressure and diastolic blood pressure were measured in millimeters of mercury (mmHg). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
778942|NCT00785577|Secondary|Number of Participants With Serious Treatment Emergent Abnormal High or Low Laboratory Values|"The number of participants by treatment group who had abnormal high or low laboratory values was reported by the investigator and summarized as serious adverse events (SAEs) from the Investigations system organ class during the treatment phase of the study. A listing of SAEs is located in the Reported Adverse Event module."|Baseline through 5 weeks|The safety analysis population included all 273 participants randomized to study drug.||participants|||Number
778943|NCT00785577|Secondary|Number of Participants Who Discontinued Due to Adverse Events (AEs) During the Therapy (Double-blind) Phase and 1-Week Washout (Follow-up) Phase|Participant discontinuation in the study due to serious and other non-serious AEs was measured during both the therapy (double-blind) phase and 1-week washout (follow-up) phase. A listing of serious and other non-serious AEs is located in the Reported Adverse Event module.|Baseline through 6 weeks|The safety analysis population included all 273 participants randomized to study drug.||participants|||Number
778944|NCT00785577|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Global Impairment Score at 5 Weeks|The SDS was completed by the participant and was used to assess the effect of the participant's symptoms on work/social/family life. Total scores ranged from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.||units on a scale||Standard Error|Least Squares Mean
778945|NCT00785577|Secondary|Change From Baseline of European Quality of Life Scale - 5 Dimensions (EQ-5D) at 5 Weeks: United States Population Based Index Score|The EQ-5D was a generic, multidimensional, health-related, quality-of-life instrument. The profile allowed participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 was generated for each domain. For each participant, the outcome rating on the 5 domains was mapped to a single index through an algorithm. The index ranged between 0 and 1, with the higher score indicating a better health state perceived by the participant.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.||units on a scale||Standard Error|Least Squares Mean
778946|NCT00785577|Secondary|Change From Baseline in Short Form-36 (SF-36) Health Survey Bodily Pain Score at 5 Weeks|The SF-36 Health Status Survey was a generic, health-related scale assessing participants’ quality of life on 8 domains (physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health) and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). MCS and PCS scores=0-100 (higher scores indicate better health status). Domain scores: general health=5-25; physical functioning=10-30; role-physical=4-8; role-emotional=3-6; social functioning=2-10; bodily pain=2-11; vitality=4-24; mental health=5-30.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.||units on a scale||Standard Error|Least Squares Mean
778984|NCT00786188|Secondary|Change From Baseline in Hot Flash Composite Score at Week 4 and Week 8|"A scale was not used for this measurement.
Composite scores of hot flashes were calculated by using the following formula:
CS = (2 • Fm + 3 • Fs)
Where:
CS = composite score Fm = frequency of moderate hot flashes Fs = frequency of severe hot flashes The mean number of moderate and severe hot flashes recorded in the Run-In Period was used to calculate the baseline composite score."|Week 4 and Week 8|||Composite score||Standard Error|Mean
791699|NCT00879814|Primary|Percentage of Participants With at Least One Adverse Event (AE)||Baseline up to Month 7|||percentage of participants|||Number
778947|NCT00785577|Secondary|Change From Baseline in Neuropathy-Specific Quality of Life (NeuroQoL) Questionnaire Score at 5 Weeks|NeuroQoL had 29 items: 13 assessed specific somatic experiences (pain, lost/reduced feeling, and diffuse sensory-motor symptoms); 14 assessed specific functional, social, and emotional experiences (restrictions in daily living activities, disruptions in social relationships, and emotional distress); 2 items assessed QoL and overall satisfaction. Items reported on a 5‑point scale (never/not at all to all of the time/very much). Higher mean scores=more severe symptoms/greater disruption in functioning. First 27 items also associate with 3‑point bothersome/importance scale (1=none to 3=very).|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.||units on a scale||Standard Error|Least Squares Mean
778948|NCT00785577|Secondary|Change From Baseline in Assessment of Sleep Questionnaire (ASQ) Total Score at 5 Weeks|ASQ consisted of 21 items (including a single item to assess overall sleep quality) and 3 subscales: Sleep Onset and Maintenance (items 1-3, 5-6, 9, 11); Sleep Experience (items 4, 7, 8, 10, 12); and Awakening Experience (items 13-20). Each item was scored on a 5-point Likert scale, ranging from 0 (no sleep at all) to 5 (a lot of sleep). Each subscale was calculated as the mean of the individual items comprising the subscale. A total ASQ score was calculated as the mean of the subscale scores; higher scores represent better sleep.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.||units on a scale||Standard Error|Least Squares Mean
778949|NCT00785577|Secondary|Change From Baseline in Short-form McGill Pain Questionnaire (SF-MPQ) Sensory Subscale Score at 5 Weeks|SF-MPQ consisted of 11 sensory descriptors describing pain that were rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. Three pain scores were derived from the sum of the intensity rank values of the words chosen for sensory descriptors. The SF-MPQ sensory subscale was the sum of the 11 scores (ranged from 0 to 33, with 33 being the worst). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.||units on a scale||Standard Error|Least Squares Mean
778950|NCT00785577|Secondary|Patient Global Impression of Improvement (PGI-I) Score at 5 Weeks|PGI-I measured the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranged from 1 (very much better) to 7 (very much worse). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Week 5|The analysis population was a modified intent to treat (ITT) population defined as participants who received either study drug with only postbaseline data collected.||units on a scale||Standard Error|Least Squares Mean
778951|NCT00785577|Secondary|Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at 5 Weeks|CGI-S measured severity of illness at the time of assessment compared with start of treatment. Scores ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.||units on a scale||Standard Error|Least Squares Mean
778952|NCT00785577|Secondary|Change From Baseline in Brief Pain Inventory - Severity (BPI-S) Subscale Score at 5 Weeks|BPI-S measured self-reported severity of pain. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and current pain. LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.||units on a scale||Standard Error|Least Squares Mean
778953|NCT00785577|Secondary|Change From Baseline in Average Brief Pain Inventory - Interference (BPI-I) Subscale Score at 5 Weeks|Average BPI-I measured self-reported degree of pain interference on function. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items. LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.||units on a scale||Standard Error|Least Squares Mean
778954|NCT00785577|Secondary|Number of Participants With 30% Reduction in Weekly Mean 24-hour Average Pain Severity (APS) Score|This scale measured the number of participants with a 30% reduction in weekly mean 24-hour APS score from baseline to endpoint. Data were recorded daily (preferably at bedtime) on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain).|Baseline through 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure. LOCF was conducted on the primary efficacy measure modified ITT population.||participants|||Number
778955|NCT00785577|Secondary|Change From Baseline in Weekly Mean Worst Daily Pain Severity Score at 5 Weeks|This scale measured worst pain APS scores. Data were recorded daily (preferably at bedtime) on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.||units on a scale||Standard Error|Least Squares Mean
779012|NCT00786565|Primary|Mesoptic Contrast Sensitivity|The mean mesoptic (low light) contrast sensitivity for each spatial frequency (cycle per degree-CPD) (1.5, 3.0, 6.0, 12.0 and 18 cpd)|3 Months|All patients who had cataract surgery and who have at least one baseline value and one post-baseline value for efficacy criteria.||Log 10||Standard Deviation|Mean
791700|NCT00879879|Secondary|6-minute Walk Test Results||1 year||||||
791701|NCT00879879|Secondary|Baseline/Transition Dyspnea Index||1 year||||||
778957|NCT00785577|Primary|Change From Baseline in Weekly Mean 24-hour Average Pain Severity (APS) Score at 5 Weeks|This scale measured 24-hour APS scores. Data were recorded daily (preferably at bedtime) on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Least Squares (LS) Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure. Last observation carried forward (LOCF) was conducted on the primary efficacy measure modified ITT population.||units on a scale||Standard Error|Least Squares Mean
778958|NCT00785629|Primary|Serum Phosphorus|mean serum phosphorus from months 3-9|months 3-9|ITT analysis was ALL active patients combined versus all placebo patients combined||mg/dL||Standard Deviation|Mean
778959|NCT00785707|Secondary|Change in LEAQ Scale Score of Cochlear Implanted Children Over 24 Months After First CI Fitting|The LittleEARS auditory questionnaire (LEAQ) uses parent responses to assess auditory behavior in children up to 24 months of age. The questionnaire is scored from 0 to 35 with 0 indicating poorer performance and 35 indicating better performance. There are no subscales for the questionnaire. This outcome measure is reported as a change on the LEAQ scale from initial CI fitting to 24 months.|24 months|||units on a scale||Full Range|Mean
778960|NCT00785707|Primary|To Validate the LittleEARS Auditory Questionnaire|The LittleEARS auditory questionnaire (LEAQ) uses parent responses to assess auditory behavior in children up to 24 months of age. The questionnaire is scored from 0 to 35 with 0 indicating poorer performance and 35 indicating better performance. There are no subscales for the questionnaire.|24 months|||units on a scale||Full Range|Mean
778961|NCT00785772|Primary|Ratio of Observed Plasma Gabapentin Concentration to Individual Predicted Plasma Gabapentin Concentration|Ratio of observed plasma gabapentin concentration to individual predicted plasma gabapentin concentration were calculated on Day 8 and Day 15, respectively.|Days 8 and 15|The Pharmacokinetics (PK) concentration analysis population is defined as all subjects treated who have at least 1 of the PK parameters of interest.||Ratio|||Number
778962|NCT00785772|Primary|Ratio of Observed Plasma Gabapentin Concentration to Predicted Plasma Gabapentin Concentration Based on Population Pharmacokinetics Model|Ratio of observed plasma gabapentin concentration to predicted plasma gabapentin concentration based on population pharmacokinetics model were calculated on Day 8 and Day 15, respectively.|Days 8 and 15|The Pharmacokinetics (PK) concentration analysis population is defined as all subjects treated who have at least 1 of the PK parameters of interest.||Ratio|||Number
778963|NCT00785772|Primary|Observed Plasma Gabapentin Concentration|Plasma gabapentin concentrations were measured on Day 8 and Day 15|Days 8 and 15|The Pharmacokinetics (PK) concentration analysis population is defined as all subjects treated who have at least 1 of the PK parameters of interest.||µg/mL||Full Range|Mean
778964|NCT00785785|Primary|Time to Progression Free Survival (PFS)|PFS was defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause. Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|up to month 37|Full Analysis Set (FAS) consists of all randomized patients for the Core Phase.||months||Full Range|Median
778965|NCT00785798|Primary|Number of Subjects With Stable Disease (SD)||2 years|||participants|||Number
778966|NCT00785798|Primary|Number of Subjects With Progressive Disease (PR)||2 years|||participants|||Number
778967|NCT00785980|Primary|Area Under the Concentration Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)].|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞)was calculated as the sum of the AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|Serial pharmacokinetic blood samples for quinine sulfate collected on Days 1 and 11 before dosing and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 36 hours post-dose.|Pharmacokinetic analyses are based on 20 subjects out of the 21 subjects who completed the study. One value was determined to be unreliable and was not used.||ng-hr/mL||Standard Deviation|Mean
778968|NCT00785980|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve beginning from the first dose (time 0) to the last measurable concentration (time t), as calculated by the linear trapezoidal method.|Serial pharmacokinetic blood samples for quinine sulfate collected on Days 1 and 11 before dosing and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 36 hours post-dose.|||ng-hr/mL||Standard Deviation|Mean
778969|NCT00785980|Primary|Maximum Plasma Concentration(Cmax)|The maximum or peak concentration that the drug reaches in the plasma.|Serial pharmacokinetic blood samples for quinine sulfate collected on Days 1 and 11 before dosing and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 36 hours post-dose.|Pharmacokinetic analyses are based on twenty-one (21) subjects who successfully completed the study. Three (#3) subjects were dropped by the sponsor due to protocol violation.||ng/mL||Standard Deviation|Mean
778970|NCT00786032|Primary|BCI System Usage by the ALS Patient|This study will look at the 14 independent users usage of the BCI system. The continued use will be assessed by selection rate. Accuracy rate – The proportion of correct selections made during the daily calibration period of “copy spelling.” Copy spelling data refers to data collected while the patient attends to and selects specific predefined characters, this allows the data to be coded properly (e.g, THE QUICK BROWN FOX JUMPS OVER THE LAZY DOG). Copy spelling data is used for calibration and will be collected at least 2x/week, and may be collected more frequently if unstable performance could be improved by more frequent calibration runs. The number of selections/min for the BCI applications was averaged across users.|Up to 18 months|||number of selection per minute||Standard Deviation|Mean
779013|NCT00786565|Secondary|High Contrast Visual Acuity||12 months|Patients without missing values for HCVA logmar at pre-operative and post operative at 1 month control.||LogMAR||Standard Deviation|Mean
779014|NCT00786565|Secondary|High Contrast Visual Acuity Best Corrected||3 months|Patients without missing values for BHCVA logmar at pre-operative and post operative at 1 month control.||LogMAR||Standard Deviation|Mean
779015|NCT00786565|Secondary|High Contrast Visual Acuity Uncorrected||3 months|Patients without missing values for UHCVA logmar at pre-operative and post operative at 1 month control.||LogMAR||Standard Deviation|Mean
791702|NCT00879879|Secondary|Total Lung Capacity by Plethysmography||1 year||||||
791703|NCT00879879|Secondary|Diffusion Capacity of Carbon Monoxide (DLCO)||1 year||||||
778971|NCT00786032|Primary|BCI System Usage by the ALS Patient|This study will look at the 14 independent users usage of the BCI system. The continued use will be assessed by accuracy. Accuracy rate – The proportion of correct selections made during the daily calibration period of “copy spelling.” Copy spelling data refers to data collected while the patient attends to and selects specific predefined characters, this allows the data to be coded properly (e.g., THE QUICK BROWN FOX JUMPS OVER THE LAZY DOG). Copy spelling data is used for calibration and will be collected at least 2x/week, and may be collected more frequently if unstable performance could be improved by more frequent calibration runs. The independent-use periods of the 14 independent users was totaled by days. Of these days, BCI use was not possible for days (i.e. hiatus days) due to hospitalization, illness, home construction, travel, or BCI system assistant (SA) absence. Over these days, copy-spelling accuracy was averaged.|Up to 18 months|||percentage of days||Standard Deviation|Mean
778972|NCT00786032|Primary|BCI System Usage by the ALS Patient|This study will look at the 14 independent users usage of the BCI system. The continued use will be assessed by time per application.|Up to 18 months|||percentage of BCI time||Standard Deviation|Median
778973|NCT00786032|Secondary|Facility Support Speed of Solution|This study will look at how the technical problems of the BCI are supported by the facility through analyzing the speed of solution.|Up to 18 months|||hours||Standard Deviation|Mean
778974|NCT00786032|Secondary|Time of BCI Impact on the Significant Other and Systems Operator|The quality of life of the significant other, caregiver and system operator will be measured using the Caregiver Burden Assessment at visits. At three month intervals, the significant other, caregiver and system operator will be asked to estimate how much time they spend on the following tasks per day in minutes: BCI System setup ( placing the electrode cap and initiating system operation), BCI System cleanup, and BCI System maintenance (removing cap).|Up to 18 months|||minutes||Standard Deviation|Mean
778975|NCT00786032|Secondary|BCI Usage by and Impact on the ALS Patient|At three-month intervals, BCI use will be summarized. On a daily basis the BCI will record the total of number of selections made in copy spelling mode. Copy spelling mode is used for system calibration. Participants are expected to indicate that the burden associated with BCI use is inconsequential to the benefit derived from using the BCI. This will be assessed by the McGill Quality of Life (MQOL) at each visit.|Up to 18 months|||units on a scale||Standard Deviation|Mean
778976|NCT00786032|Primary|BCI System Usage by the ALS Patient|This study will look at the 14 independent users usage of the BCI system. The continued use will be assessed by total time.|Up to 18 months|||days||Standard Deviation|Mean
778977|NCT00786188|Secondary|Effect of Brisdelle (Paroxetine Mesylate) Capsules on BMI at Week 4 and Week 8|Body Mass Index (BMI) was calculated by using height in centimeters and weight in kilograms.|Week 4 and Week 8|||BMI Kg/m2||Standard Error|Mean
778978|NCT00786188|Secondary|Proportion of Numerical Rating Scale (NRS) True Responders at Week 4 and Week 8|"The Subject Impression Numerical Rating Scale (NRS) is an 11-point scale was used to measure how bothered a subject was by hot flashes both during the day and the night.
The measure being reported below is percentage of responders who had an improvement in NRS score at Week 4 compared to baseline. A responder is defined as a subject who had an improvement in the NRS score. An improvement is define as a score ≤3 on each question."|Week 4 and Week 8|||Percentage of true responders|||Number
778979|NCT00786188|Secondary|Asses the Effect of Brisdelle (Paroxetine Mesylate) Capsules on the Interference on Sexual Functioning at Week 8|The Arizona Sexual Experiences Scale (ASEX) is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm. Possible total scores range from 5 to 30, with the higher scores indicating more sexual dysfunction. The sum of the scores for all 5 items was calculated.|Week 8|||units on a scale||Standard Error|Mean
778980|NCT00786188|Secondary|Proportion of Clinical Global Impression (CGI) Responders at Week 4 and Week 8|The Clinical Global Impression Scale (CGIS) was completed by the investigator and was used to measure the severity of the VMS at any given time and the improvement from baseline. Responders were defined as subjects who achieved a score of 1 to 3 where 1 = very much improved, 2 = much improved, and 3 = minimally improved. Non-responders were defined as subjects who achieved a score of 4 to 7 where 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.|Week 4 and Week 8|||Percentage of participants|||Number
778981|NCT00786188|Secondary|Effect of Brisdelle (Paroxetine Mesylate) Capsules on Improvement of Hot Flash Interference at Week 4|"Interference of hot flashes was measured by using the Hot Flash-Related Daily Interference Scale (HFRDIS). The HFRDIS is a 10-item scale that measures the degree to which hot flashes interfere with 9 daily activities and the tenth item measures the degree to which hot flashes interfere with each of the other items. Subjects can score for each item on a scale from 0 to 10 where 0 = Do not interfere and a score of 10 = Completely interferes.
The measure being reported below is percentage of responders who had an improvement in HFRDIS score at Week 4 compared to baseline. A responder is defined as a subject who had an improvement in the HFRDIS score. An improvement is define as a score ≤3 on each question."|Week 4|||percentage of responders|||Number
778982|NCT00786188|Secondary|Effect of Brisdelle (Paroxetine Mesylate) Capsules on Mood at Week 4|"Mood was measured using the Profile of Mood States (POMS) Questionnaire. The Profile of Moods States (POMS) is a 65-item multi-dimensional measure that provides a method of assessing transient, fluctuating active mood states. Key areas that are measured include: tension-anxiety, anger-hostility, fatigue-inertia, depression-dejection, vigor-activity, confusion-bewilderment. Responses to questions are scored with the following numerical values: Not at all = 1, A little = 2, Moderate = 3, Quite a bit = 4, Extremely = 5. A total score for a domain was obtained by summing the responses of individual items in the domain. The total POMS score can range from 65 to 335.
The percentage of participants who had a change from baseline in the total score at Week 4 is reported below."|Week 4|||percentage of participants|||Number
778983|NCT00786188|Secondary|Effect of Brisdelle (Paroxetine Mesylate) Capsules on Depression and Anxiety at Week 8|"Depression & anxiety were measured using the Hospital Anxiety & Depression Scale (HADS).
The HADS is a scale developed to assess anxiety & depression. The HADS Scale consists of 14 Questions (7 relating to anxiety; 7 relating to depression) with possible scores ranging from 0 to 21.
The results presented below are the number of participants with abnormal HADS Scores for both Abnormal Anxiety & Abnormal Depression combined at Week 8."|Week 8|||participants|||Number
783630|NCT00819156|Secondary|Number of Patients With Testosterone <=0.5 Nanogram/Milliliter at Day 28.|The number of patients who achieved the <=0.5 nanogram/milliliter level for serum testosterone after the initial dose cycle.|Day 28|ITT population.||participants|||Number
778985|NCT00786188|Secondary|Change From Baseline in Climacteric Symptoms at Week 8|"The Greene Climacteric Scale (GCS) was used for this measurement. The scale has 21 questions and measures symptoms in 4 areas; these are psychological (anxiety and depression), physical, vasomotor, and libido.
The severity of the symptom was scored as: 0=none, 1=mild, 2=moderate, and 3=severe. Anxiety was determined by using the sum of scores 1 to 6, and depression was determined by using the sum of scores 7 to 11. Physical aspects were determined by using the sum of scores 12 to 18; vasomotor aspects were determined by using the sum of scores 19 to 20; and libido was determined by using the score for question 21.
The total GCS score ranges from 0 to 63 which is the sum of all the scores for the 21-symptom assessment questions in this scale. Each subject’s total GCS score at baseline and at Week 8 were used to calculate change from baseline in these symptoms. The change from baseline is reported below."|Week 8|||units on a scale||Standard Error|Mean
778986|NCT00786188|Primary|Mean Change From Baseline in Hot Flash Severity at Week 4 and Week 8|"A scale was not used to measure severity scores. Severity scores of hot flashes were calculated for each subject. The following formula was used to calculate severity.
SS = (2•Fm + 3•Fs) ÷ (Fm + Fs)
Where:
SS = severity score Fm = frequency of moderate hot flashes Fs = frequency of severe hot flashes The mean number of moderate and severe hot flashes that was recorded in the Run-In Period was used to calculate the baseline severity score."|Week 4 and Week 8|||Severity score||Standard Error|Mean
778987|NCT00786188|Primary|Mean Change From Baseline in Hot Flash Frequency at Week 4 and Week 8|"The number of hot flashes reported in the result table are:
Mean change in frequency of moderate to severe VMS from baseline to Week 4
Mean change in frequency of moderate to severe VMS from baseline to Week 8. They are both measured as hot flashes per week."|Week 4 and Week 8|MODIFIED ITT (MITT) POPULATION Brisdelle 49 (98.0%) Placebo 52 (100.0%) PER PROTOCOL (PP) POPULATION Brisdelle 45 (90.0%) Placebo 51(98.1%)||Hot flashes||Standard Error|Mean
778988|NCT00786422|Secondary|Percentage of Participants With Other Vascular Events|All events were adjudicated and confirmed by a central independent adjudication committee. Other vascular events comprised ST segment elevation myocardial infarction (STEMI), non-ST segment elevation myocardial infarction (NSTEMI), unstable angina (UA), ischemic stroke, transient ischemic attack (TIA), non-central nervous system systemic embolism and vascular death.|Up to 3 months treatment and during subsequent 1 day|The safety population consisted of all participants who received at least 1 dose of rivaroxaban.||Percentage of participants|||Number
778989|NCT00786422|Secondary|Percentage of Participants With Treatment Emergent Deaths - 7 Days Window|Treatment emergent deaths were adjudicated by a central independent adjudication committee. Participants who died from treatment emergent adverse events were counted for this measure.|Up to 3 months treatment and during subsequent 7 days|All participants||Percentage of participants|||Number
778990|NCT00786422|Secondary|Percentage of Participants With All Deaths|All deaths were adjudicated by a central independent adjudication committee. Participants who died for any reason were counted for this measure.|Up to 3 months and on-treatment (up to 2 days after stop of study drug) plus an observational period planned for one month|All participants||Percentage of participants|||Number
778991|NCT00786422|Secondary|Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Non-fatal or Fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee. The composite efficacy outcome symptomatic recurrent VTE was analyzed descriptively, with the components: Death due to PE, death for which PE cannot be excluded, symptomatic PE and DVT, symptomatic recurrent PE only, and symptomatic recurrent DVT only up to the end of intended treatment period (3 months; 98 study days) and on-treatment (up to 2 days after stop of study drug).|Up to 3 months treatment and during subsequent 30-day observational period for an individual participant|The safety population consisted of all participants who received at least 1 dose of rivaroxaban.||Percentage of participants|||Number
778992|NCT00786422|Primary|Percentage of Participants With Clinically Relevant Bleeding (i.e. Major Bleeding and Clinically Relevant Non-major Bleeding)|All events were adjudicated and confirmed by a central independent adjudication committee. Clinically relevant bleeding included major bleeding (overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of 2 or more units of packed red blood cells or whole blood, occurring in a critical site or contributing to death) and non-major bleeding associated with medical intervention, unscheduled physician contact, (temporary) cessation of study treatment, discomfort for the participants such as pain, or impairment of activities of daily life.|Up to 3 months treatment and during subsequent 2 days|The safety population consisted of all participants who received at least 1 dose of rivaroxaban.||Percentage of participants|||Number
778993|NCT00786422|Primary|Pharmacokinetics – Cmin,ss (Minimum Observed Drug Concentration in Measured Matrix at Steady State During a Dosage Interval) of Rivaroxaban|Cmin,ss was predicted for each individual participant from rivaroxaban plasma concentrations and was only considered for the time period during which participants concomitantly received rivaroxaban and a strong CYP3A4 inducer.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban|The pharmacokinetics/pharmacodynamics (PK/PD) population included all participants who received at least 1 dose of rivaroxaban and had at least 1 valid PK/PD sample after first administration||µg/L||90% Confidence Interval|Median
778994|NCT00786422|Primary|Pharmacokinetics – Cmax,ss (Maximum Observed Drug Concentration in Measured Matrix at Steady State During a Dosage Interval) of Rivaroxaban|Cmax,ss was predicted from rivaroxaban plasma concentrations for each individual participant and was only considered for the time period during which participants concomitantly received rivaroxaban and a strong CYP3A4 inducer.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban|The pharmacokinetics/pharmacodynamics (PK/PD) population included all participants who received at least 1 dose of rivaroxaban and had at least 1 valid PK/PD sample after first administration||µg/L||90% Confidence Interval|Median
778995|NCT00786422|Primary|Pharmacokinetics - AUC(0-24)ss (Area Under the Measurement Versus Time Curve From Time 0 to 24 Hours After First Dosing on a Day at Steady State) of Rivaroxaban|AUC(0-24)ss was predicted from rivaroxaban plasma concentrations for each individual participant and was only considered for the time period during which participants concomitantly received rivaroxaban and a strong cytochrome P450 isoenzyme 3A4 (CYP3A4) inducer.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban|The pharmacokinetics/pharmacodynamics (PK/PD) population included all participants who received at least 1 dose of rivaroxaban and had at least 1 valid PK/PD sample after first administration||(µg*h)/L||90% Confidence Interval|Median
778996|NCT00786422|Primary|Pharmacodynamics - Prothrombin Time (PT), Slope|Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out of PT is in seconds. The PT slope describes the linear increase of PT for one unit increase in concentration, thus the unit of PT slope is s*(µg/L)^-1. The final population PK/PD model included a fixed slope that was fitted to the data of the 19 patients that were eligible for evaluation. The estimated mean value (fixed/ the same for all patients in this study) is presented for PT slope.|Up to 3 months treatment|The pharmacokinetics/pharmacodynamics (PK/PD) population included all participants who received at least 1 dose of rivaroxaban and had at least 1 valid PK/PD sample after first administration||s*(µg/L)^-1|||Number
778997|NCT00786422|Primary|Pharmacodynamics - Prothrombin Time (PT), Baseline Value|Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds. Mean and standard deviation (SD) values are presented for PT baseline.|The baseline value of prothrombin time is measured or calculated at a rivaroxaban concentration of 0 µg/L and is based on the observations that were made during the 3 months treatment period|The pharmacokinetics/pharmacodynamics (PK/PD) population included all participants who received at least 1 dose of rivaroxaban and had at least 1 valid PK/PD sample after first administration||Seconds||Standard Deviation|Mean
778998|NCT00786474|Secondary|Number of Participants With Minor Bleeding|Minor bleeding is defined as symptomatic or clinically-overt bleeding that does not satisfy the criteria for major bleeding|from subject signing of the consent until completed the study (Day -30 to Day +37)|Of the 1,884 subjects enrolled in the trial, 71 discontinued participation and did not provide outcome data||participants|||Number
778999|NCT00786474|Secondary|Number of Subjects With Death, Acute Myocardial Infarction, Deep Vein Thrombosis, or Pulmonary Embolism||from subject signing of the consent until completed the study (Day -30 to Day +37)|Of the 1,884 subjects enrolled in the trial, 71 discontinued participation and did not provide outcome data.||participants|||Number
779000|NCT00786474|Primary|Major Bleeding|Major bleeding is defined as symptomatic bleeding associated with transfusion of more than two units of packed red blood cells or whole blood, or death|from subject signing of the consent until completed the study (Day -30 to Day +37)|Of the 1,884 subjects enrolled in the trial, 71 discontinued participation and did not provide outcome data.||participants|||Number
779001|NCT00786474|Primary|Number of Arterial Thromboembolic Events|The events are defined as arterial thromboembolism: stokes, transient ischemic attack and systemic embolism events were independently and blindly adjudicated|from subject signing of the consent until completed the study (Day -30 to Day +37)|Of the 1,884 subjects enrolled in the trial, 71 discontinued participation and did not provide outcome data.||Arterial thromboembolic events|||Number
779002|NCT00786487|Primary|Insulin Sensitivity as Measured by Hyperinsulinemic Euglycemic Clamp at a Single Time Point (6 Hrs) After Intralipid or Glycerol Infusion|Insulin sensitivity (M value: Glucose infusion rate/kg FFM/min)measured at single time point 6 hours after initiating either intralipid or glycerol infusion)|at 6 hours after starting lipid/glycerol infusion|||M value||Standard Deviation|Mean
779003|NCT00786565|Secondary|Posterior Capsule Opacification|Posterior Capsule Opacification Score (PCO), Density of opacification measured from 0-4 (1=minimal and 4=severe) and area of opacification measured from 0-1 (0=no opacification and 1=posterior capsule opacification required a treatment). Results (EPCO) were computer calculated by multiplying density by area of opacification.|12 months|The EPCO score, evaluated by an independent observer using retro-illumination pictures, all pictures available. Measured in a 3mm and 6mm optic area.||EPCO Score||Standard Deviation|Mean
779004|NCT00786565|Secondary|Contrast Sensitivity Mesoptic|The mean mesopic (dim light) contrast sensitivity were to be compared between both IOLs for each special frequency (1.5, 3.0, 6.0, 12.0 and 18 cpd)|1 month|All patients who had cataract surgery and who have at least one baseline value and one post-baseline value for efficacy criteria.||Log 10||Standard Deviation|Mean
779005|NCT00786565|Secondary|Contrast Sensitivity Mesoptic 1.5 Cpd|The mean mesopic (dim light) contrast sensitivity were to be compared between both IOLs for each special frequency (1.5, 3.0, 6.0, 12.0 and 18 cpd)|1 month|All patients who had cataract surgery and who have at least one baseline value and one post-baseline value for efficacy criteria.||Log 10||Standard Deviation|Mean
779006|NCT00786565|Secondary|Contrast Sensitivity Photopic|The mean photopic (day light) contrast sensitivity were to be compared between both IOLs for each special frequency (1.5, 3.0, 6.0, 12.0 and 18 cpd)|1 month|All patients who had cataract surgery and who have at least one baseline value and one post-baseline value for efficacy criteria.||Log 10||Standard Deviation|Mean
779007|NCT00786565|Secondary|Contrast Sensitivity Photopic 1.5cpd|The mean photopic (day light) contrast sensitivity were to be compared between both IOLs for each special frequency (1.5, 3.0, 6.0, 12.0 and 18 cpd)|1 month|All patients who had cataract surgery and who have at least one baseline value and one post-baseline value for efficacy criteria.||Log 10||Standard Deviation|Mean
779008|NCT00786565|Secondary|Low Contrast Visual Acuity|Uncorrected Low contrast visual acuity - LogMar visual acuity value|1 month|All patients who had cataract surgery and who have at least one baseline value and one post-baseline value for efficacy criteria.||LogMar||Standard Deviation|Mean
779009|NCT00786565|Secondary|High Contrast Visual Acuity Best Corrected||24 Months|Patients without missing values for best corrected HCVA logmar at pre-operative and post operative at 1 month control.||LogMar||Standard Deviation|Mean
779010|NCT00786565|Secondary|High Contrast Visual Acuity Uncorrected||24 Months|Patients without missing values for UHCVA logmar at pre-operative and post operative at 1 month control.||LogMar||Standard Deviation|Mean
779011|NCT00786565|Primary|Posterior Capsule Opacification Score|Posterior Capsule Opacification Score (PCO), Density of opacification measured from 0-4 (1=minimal and 4=severe) and area of opacification measured from 0-1 (0=no opacification and 1=posterior capsule opacification required a treatment). Results (EPCO) were computer calculated by multiplying density by area of opacification.|24 months|The EPCO score, evaluated by an independent observer using retro-illumination pictures, all pictures available. Measured in a 3mm and 6mm optic area.||EPCO Score||Standard Deviation|Mean
792571|NCT00893971|Primary|Vital Sign Change Baseline; Blood Pressure|Vital sign change baseline; blood pressure|12 hours|All subjects in the Safety Population that had a valid measurement for the parameter||mmHg||Full Range|Mean
779019|NCT00786565|Primary|Low Contrast Best Corrected Visual Acuity Following Cataract Surgery|Low contrast best corrected visual acuity (ability to distinguish objects on a similarly colored or shaded background) 3 months following cataract surgery.|3 months|Number of participants 67 total with 67 eyes in each group, full analysis set, all randomized participants who had cataract surgery one intraocular lens (IOL) in each eye, and who had at least one baseline value and one post-baseline value for efficacy.||LogMAR||Standard Deviation|Mean
779020|NCT00786643|Secondary|Time to Progression|Patients were censored if they did not progress, stopped particiaption due to an adverse event, or withdrew consent following the start of study treatment. Response was evaluated by Response Evaluation Criteria In Solid Tumors (RECIST) guidelines version 1.0. Per RECIST v1.0, Progressive Disease (PD) is defined as a measurable increase in smallest diameter of any target or non-target lesion, or the appearance of new lesions, since baseline.|From date of study treatment start until date of first documented progression or date of death from any cause, whichever came first, assessed up to 15 months|||Months||95% Confidence Interval|Median
779021|NCT00786643|Secondary|Early Response Rate (RR) (Stratum 1 Only)|Early RR evaluated in stratum 1 to see if bevacizumab (bev) would be added to GFL treatment (tx). Patients with stable disease (SD) pre 5th cycle of tx had bev added. Response was evaluated by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0. Per RECIST and CT scan: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in sum of longest diameter (LD) of target lesions; SD, neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of >=20%; Progressive Disease (PD), increase in existing lesions or new lesions.|After 4 cycles of treatment (approximately 56 days)|Prior to the 5th cycle of treatment, early response rate was evaluated in patients in stratum 1 to assess whether bevacizumab would be added to the GFL treatment regimen. Stratum 1 patients with SD at this time point will have bevacizumab added to the regimen. Subjects in stratum 2 were not evaluated for this outcome.||Participants|||Number
779022|NCT00786643|Primary|Best Response (BR)|BR is recorded from start of treatment until progressive disease (PD). Imaging was repeated by same technique after every 4 cycles of treatment. Response was evaluated per Response Evaluation Criteria In Solid Tumors (RECIST) guidelines version 1.0. Per RECIST v1.0 and CT scan: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of >=20%; PD, increase in existing lesions or new lesions.|After every 4 cycles of treatment (approximately every 56 days for up to about 280 days)|The best response is the best response recorded from the start of treatment until disease progression. Imaging was repeated by same technique after every 4 cycles of treatment. Subjects in both strata were evaluated for this outcome.||Participants|||Number
779023|NCT00786682|Secondary|Overall Survival||10 years|Study was terminated prematurely and insufficient data was collected to assess this outcome measure.|||||
779024|NCT00786682|Secondary|Time to Disease Progression||10 years|Study was terminated prematurely and insufficient data was collected to assess this outcome measure.|||||
779025|NCT00786682|Primary|Tumor Response Rate - Primary Endpoint is a 50% Decline in PSA or Normalization of PSA.|We will use a two-stage optimal Simon’s design with a 5% significance level and 80% power to detect an increase in response rate from 50% to 70%. The first stage will enroll 15 patients. If there are 8 or fewer responses among these 15 patients, we will consider the combination therapy to not be worthy of further study, and stop the trial. If we find 9 or more responses, we will proceed to the second stage, and accrual continues for a total of 43 patients. If we see 26 or fewer responses out of 43, then no further investigation of the drug is warranted. If we see 27 or more responses out of 43, then further investigation of the drug will be considered. The “expected” sample size of the trial is 23.5 with the null response rate of 50%.|4 years|Upon reviewing response data for the first 8 patients, we noted that there were no responses thus far. As per the two-stage optimal Simon's design, we would need 8 responses in 15 patients to proceed to stage 2 but we would not have crossed that threshold. The study was stopped due to lack of improved efficacy compared to historical controls.|||||
779026|NCT00786799|Secondary|Change in Serum TNFα (Cytokine) Level||Baseline and 1 year|||pg/ml||Standard Deviation|Mean
779027|NCT00786799|Secondary|Change in Percentage of Serum Omega-3 Fatty Acids|Change in percentage calculated as (100% * ((One Year - Baseline)/Baseline)|Baseline and 1 year|||Percent change of levels of fatty acid||Standard Deviation|Mean
779028|NCT00786799|Primary|Group-specific and Comparison of Change in Aberrant Behavior Checklist-Hyperactivity Subscale Score (Active Omega-3 Group Only, Placebo Group Only and Comparison Between Groups)|Hyperactivity subscale of Aberrant Behavior checklist (ABC-H): measure of assessing changes in symptoms of hyperactivity in children with autism (survey that was normed on a developmentally delayed population of children and adults and is usually completed by a parent or caregiver. Items are rated on a 4-point scale from “no problem” to “major problem”). ABC-H Subscale Score ranges from 0 (best) to 45 (worst). A negative change signifies improvement.|Baseline and 1 year|||scores on a scale||Standard Deviation|Mean
779029|NCT00786838|Primary|The Difference in the Change From Baseline (Predose on Day 1) in QTc Intervals Trabectedin Relative to Placebo at 24 Hour Post Dose by Bazett’s Correction|QTc interval was measured by electrocardiograms to evaluate the potential effect of trabectedin on QTc interval duration. The Bazett’s Correction was used as the standard clinical correction for calculating the heart rate-corrected QT interval.|Baseline (predose on Day 1) to 24 hour post dose (Day 1 or Day 2)|All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations.||milli seconds||Standard Deviation|Mean
779030|NCT00786838|Secondary|Mean Heart Rate (Beats Per Minute) Over 24 Hours Postdose||Baseline (predose on Day 1) to 24 hour post dose|All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order was excluded from evaluations. 73 participants analyzed in trabectedin group to derive the mean.||beats per minute||Standard Deviation|Mean
780233|NCT00794118|Primary|Patient Global Assessment (PtGA) of Disease Activity Score at Month 6|PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad.|Month 6|ITT population included all participants who received at least 1 dose of the study medication.||cm||Standard Deviation|Mean
779031|NCT00786838|Secondary|Number of Participants With QRS Interval Greater Than 120 Milli Seconds|QRS interval is the interval from the beginning of the Q wave to the termination of the S wave, representing the time for ventricular depolarization.|Baseline (predose) to approximately 24 hour post dose|All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations.||participants|||Number
779032|NCT00786838|Secondary|Number of Participants With PR Interval Greater Than 200 Milli Seconds|PR interval is the portion of the electrocardiogram between the onset of the P wave (atrial depolarization) and the QRS complex (ventricular depolarization).|Baseline (predose) to approximately 24 hour post dose|All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations.||participants|||Number
779033|NCT00786838|Secondary|Number of Participants With QTc Interval Greater Than 500 Milli Seconds|The Fridericia (QTcF) and Bazett's (QTcB) correction were used as the standard clinical correction for calculating the heart rate-corrected QTc interval.|Baseline (predose) to approximately 24 hour post dose|All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations.||participants|||Number
779034|NCT00786838|Secondary|Number of Participants With QTc Interval Greater Than 480 Milli Seconds|The Fridericia (QTcF) and Bazett's (QTcB) correction were used as the standard clinical correction for calculating the heart rate-corrected QTc interval.|Baseline (predose) to approximately 24 hour post dose|All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations.||participants|||Number
779035|NCT00786838|Secondary|Number of Participants With QTc Interval Greater Than 450 Milli Seconds|The Fridericia (QTcF) and Bazett's (QTcB) correction were used as the standard clinical correction for calculating the heart rate-corrected QT interval.|Baseline (predose) to approximately 24 hour post dose|All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations.||participants|||Number
779036|NCT00786838|Secondary|Number of Participants With QTc Interval Increase From Baseline (Predose on Day 1) Greater Than 60 Milli Seconds|The Fridericia (QTcF) and Bazett's (QTcB) correction were used as the standard clinical correction for calculating the heart rate-corrected QT interval.|Baseline (predose) to approximately 24 hour post dose|All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations.||participants|||Number
779037|NCT00786838|Secondary|Number of Participants With QTc Interval Increase From Baseline (Predose on Day 1) Greater Than 30 Milli Seconds|The Fridericia (QTcF) and Bazett's (QTcB) correction were used as the standard clinical correction for calculating the heart rate-corrected QT interval.|Baseline (predose) to approximately 24 hour post dose|All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations.||participants|||Number
779038|NCT00786838|Secondary|Time Taken to Acheive Maximum Plasma Concentration (Tmax)||Baseline (predose on Day 2) to 24 hour post dose (Day 2 or Day 3).|All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations.||hours||Standard Deviation|Mean
779039|NCT00786838|Secondary|Maximum Plasma Concentration of Trabectedin (Cmax)||Baseline (predose on Day 2) to 24 hour post dose (Day 2 or Day 3).|All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations.||nanogram per milliliter||Standard Deviation|Mean
779040|NCT00786838|Primary|The Difference in the Change From Baseline (Predose on Day 1) in QTc Intervals Trabectedin Relative to Placebo at 24 Hour Post Dose by Fridericia Correction|QTc interval was measured by electrocardiograms to evaluate the potential effect of trabectedin on QTc interval duration. The Fridericia correction was used as the standard clinical correction for calculating the heart rate-corrected QT interval.|Baseline (predose on Day 1) to 24 hour post dose (Day 1 or Day 2)|All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations.||milli seconds||Standard Deviation|Mean
779041|NCT00786864|Secondary|Hamstring Flexibility|Standardised hamstring muscle length test. The child was positioned in supine, with the hip flexed at 90 degrees. The knee was then extended passively. The angle of knee extension [from horizontal plane (level to plinth) to fibula] was measured using a digital inclinometer. Continuous data. Scores ranged from -20 (worst score) to 82 (best score).|3 months post-intervention|Intention to treat analysis||degrees||Standard Deviation|Mean
779042|NCT00786864|Primary|Low Back Pain Intensity|The visual analogue scale (standardised 100mm, non-hatched line) was used to determine pain intensity. Scores can range between 0 and 10, with the worst possible pain/score = 10 and no pain/best score = 0. Visual analogue scale is continuous.|3 months post-intervention|Intention to treat analysis||units on a scale||Standard Deviation|Mean
779043|NCT00786864|Secondary|Neural Mobility|Straight leg raise test was used to measure neural mobility. The amount of hip flexion (angle between the plinth and femur of the raised leg) was measured using a digital inclinometer. Scores ranged between 3 (worst score) and 90.5 (best score). Continuous data.|3 months post-intervention|Intention to treat analysis||degrees||Standard Deviation|Mean
779044|NCT00786864|Primary|Low Back Pain Prevalence|All of the children complained of low back pain at baseline. Low back pain prevalence post-intervention was determined by the number of children still complaining of low back pain post-intervention.|3 months post-intervention|Intention to treat analysis||participants|||Number
779045|NCT00786916|Primary|Maximal Pain/Discomfort|"FLACC (Face, Legs, Activity, Cry, Consolability) Pain assessment scale was administered by a trained observer. The patient's parent documented maximum distress using a 100-mm visual analog scale where 0 represented no pain and 100 (the furthest point to the left) represented the worst pain ever."|during initial 3 minute propofol infusion|All enrolled subjects were randomized into groups A, B or C by hospital pharmacists utilizing a standard prerandomization methodology.||units on a scale||Standard Deviation|Mean
779046|NCT00786994|Primary|Objective Response of the Marker Actinic Keratosis, Defined as Histologically Complete or Partial Clearance.|"Objective response of the marker actinic keratosis, defined as histologically complete or partial clearance (partial clearance = down-grading in Cockerell-classification). The marker actinic keratosis is defined as an initially selected lesion within the target area that will be used for final biopsy.
The Cockerell classification refers to a single lesion, graded as the presence of atypical cells in the lower third of the epidermis (grade I), involvement of at least the lower two-thirds (grade II) or atypical keratinocytic proliferation in the entire epidermis (grade III). Thus a down-grading from a higher Cockerell grade (e.g., III) to a lower Cockerell grade (e.g., I) represents a positive outcome and treatment success."|18 weeks|||participants|||Number
779047|NCT00787020|Secondary|Cerebrospinal Fluid (CSF) Output Per Day||14 Days|||Milliliter||95% Confidence Interval|Mean
779048|NCT00787020|Secondary|External Ventricular Drain (EVD) Complications|External ventricular drain complications are defined as ventriculitis, shunt dependency, ventricular catheter obstruction requiring manipulation, or removal by the patient.|14 Days|||Participants|||Number
779049|NCT00787020|Primary|Cerebral Artery Vasospasm|Cerebral artery vasospasm is defined as transcranial doppler mean velocity greater than 120 or angiographic vasospasm determined by cerebral angiogram.|14 days|||Participants|||Number
779050|NCT00787124|Primary|SNOHgB Levels|levels were never run by the laboratory|beginning and end of study||||||
779051|NCT00787124|Secondary|Oxygen Saturation and Measures of Perfusion Pre and Post-transfusion.|data not appropriately collected for the analysis due to machine malfunctions.|prior to, during, after transfusion||||||
779052|NCT00787137|Primary|The Number of Episodes of Change From Screening in Laboratory Assessments|Red cell count, haemoglobin, haematocrit, total and differential white cell counts, platelet count, mean corpuscular volume, mean corpuscular haemoglobin, mean corpuscular haemoglobin concentration, reticulocytes; urea, creatinine, urate, bilirubin, sodium, potassium, calcium, phosphate, chloride, bicarbonate, alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase, gammaglutamyl transferase, creatine phosphokinase, albumin, protein; urine pH, protein, glucose, ketones, bilirubin, blood, urobilinogen, nitrite, leucocytes, specific gravity.|Three months|||Number of episodes of change|||Number
779053|NCT00787137|Primary|The Number of Episodes of Change in Electrocardiogram|Episodes of clinically significant change in 12-lead electrocardiogram predose,1 & 4 hours and 1 & 84 days postdose. The investigator evaluated clinical significance primarily by blinded comparison with the screening electrocardiogram.|Three months|||Number of episodes of change|||Number
779054|NCT00787137|Primary|The Number of Episodes of Change in Vital Signs|Clinically significant episodes of change in blood pressure, heart rate, temperature or respiration rate on the day before dosing and 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours and 4, 7, 14, 21, 28, 56 & 84 days after dosing. The investigator evaluated clinical significance primarily by blinded comparison with the respective screening value.|Three months|||Number of episodes of change|||Number
779055|NCT00787137|Primary|The Percentage of Participants With Adverse Events||Three months|All patients dosed were evaluated||Percentage of Participants|||Number
779056|NCT00787137|Primary|The Number of Reported Adverse Events|This was an exploratory study and all safety endpoints were considered.|Three months|All adverse events reported for all patients dosed were evaluated||Number of adverse events|||Number
779057|NCT00787150|Other Pre-specified|Mean D-Dimer at Each Time Point in Participants Treated With Warfarin or Apixaban|Below the limit of quantification (BLQ) was assigned the value 0 for calculation.|Week 0, Week 1, Week 8|The analysis set was based on all participants with relevant measurements. Participants were categorized to the actual treatment received. n=number of participants with evaluable data in Warfarin, Apixaban 2.5 mg BID, Apixaban 5.0 mg BID, respectively.||ng/mL||Standard Deviation|Mean
779058|NCT00787150|Other Pre-specified|Mean Prothrombin Fragment 1+2 (F1+2) at Each Time Point in Participants Treated With Warfarin or Apixaban|Below the limit of quantification (BLQ) was assigned the value 0 for calculation. If 50% or more of the data was BLQ, statistics was not calculated. Therefore, 0 indicates not calculated.|Week 0, Week 1, Week 8|The analysis set was based on all participants with relevant measurements. Participants were categorized to the actual treatment received. n=number of subjects with evaluable data in Warfarin, Apixaban 2.5 mg BID, Apixaban 5.0 mg BID, respectively.||pmol/L||Standard Deviation|Mean
779059|NCT00787150|Other Pre-specified|Mean Anti-Xa Activity (Apixaban Units) at Each Time Point in Participants Treated With Apixaban|Blood sample at 4 hours postdose was collected if possible. Below the limit of quantification (BLQ) was assigned the value 0 for calculation. If 50% or more of the data was BLQ, statistics was not be calculated. Therefore, 0 means not calculated.|Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8|The analysis set was based on all participants with relevant measurements. Participants were categorized to the actual treatment received. n=number of subjects with evaluable data in Apixaban 2.5 mg BID, Apixaban 5.0 mg BID, respectively.||ng/mL||Standard Deviation|Mean
779094|NCT00787254|Secondary|Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 6)|The number of participants that develop anorexia at month 6, and number of participants that develop anorexia at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 6.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
779060|NCT00787150|Other Pre-specified|Mean Activated Partial Thromboplastin Time (aPTT) at Each Time Point in Participants Treated With Apixaban|Blood Sample at 4 hours postdose was collected if possible. The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V, VIII, IX, X, XI and XII. Higher values than the baseline indicate anticoagulant effects.|Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8|The analysis set was based on all participants with relevant measurements. Participants were categorized to the actual treatment received. n=number of subjects with evaluable data in Apixaban 2.5 mg BID, Apixaban 5.0 mg BID, respectively.||Second||Standard Deviation|Mean
779061|NCT00787150|Other Pre-specified|Mean Prothrombin Time-International Normalized Ratio (PT-INR) at Each Time Point in Participants Treated With Apixaban|Blood sample at 4 hours postdose was collected if possible. PT-INR is a standardized measure derived from prothrombin time (PT). The systematic variations in PT assay results are corrected in PT-INR in order to optimize measurements of vitamin K antagonists.|Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8|The analysis set was based on all participants with relevant measurements. Participants were categorized to the actual treatment received. n=number of subjects with evaluable data in Apixaban 2.5 mg BID, Apixaban 5.0 mg BID, respectively.||International normalized ratio||Standard Deviation|Mean
779062|NCT00787150|Other Pre-specified|Mean Prothrombin Time (PT) at Each Time Point in Participants Treated With Apixaban|Sample at 4 hours postdose was to be taken if possible.|Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8|The analysis set was based on all participants with relevant measurements. Participants were categorized to the actual treatment received. n=number of subjects with evaluable data in Apixaban 2.5 mg BID, Apixaban 5.0 mg BID, respectively.||second||Standard Deviation|Mean
779063|NCT00787150|Other Pre-specified|Mean Plasma Apixaban Concentration at Each Time Point in Participants Treated With Apixaban|Sample at 4 hours postdose was to be taken if possible.|0, 2, 4 hours postdose at Week 1 and Week 8|The pharmacokinetic analysis set was defined as participants treated with apixaban, who were not assessed as major protocol violators, and in whom at least one observation of plasma apixaban concentration. n=number of participants with evaluable data in Apixaban 2.5 mg BID, Apixaban 5.0 mg BID, respectively.||ng/mL||Standard Deviation|Mean
779064|NCT00787150|Secondary|Number of Participants With Myocardial Infarction or All-Cause Death During the Intended Treatment Period|The definition of the “Intended Treatment Period” was the period starting on the day of randomization and ending at the later one of either 2 days after the last dose of the study drug or Day 85/Week 12 after the randomization day.|Baseline to Week 12|Full analysis set (FAS) was defined as all randomized participants. Participants were categorized to the group to which they were assigned by the randomization system, regardless of the treatment actually received.||participants|||Number
779065|NCT00787150|Secondary|Number of Participants With Stroke, Systemic Embolism, or All-Cause Death During the Intended Treatment Period|The definition of the “Intended Treatment Period” was the period starting on the day of randomization and ending at the later one of either 2 days after the last dose of the study drug or Day 85/Week 12 after the randomization day.|Baseline to Week 12|Full analysis set (FAS) was defined as all randomized participants. Participants were categorized to the group to which they were assigned by the randomization system, regardless of the treatment actually received.||participants|||Number
779066|NCT00787150|Secondary|Number of Participants With Stroke or Systemic Embolism During the Intended Treatment Period|The definition of the “Intended Treatment Period” was the period starting on the day of randomization and ending at the later one of either 2 days after the last dose of the study drug or Day 85/Week 12 after the randomization day.|Baseline to Week 12|Full analysis set (FAS) was defined as all randomized participants. Participants were categorized to the group to which they were assigned by the randomization system, regardless of the treatment actually received.||participants|||Number
779067|NCT00787150|Secondary|Number of Participants With Clinically Relevant Non-major Bleeding Events During the Treatment Period|Clinical relevant non-major bleeding was acute or sub-acute clinically overt bleeding that does not satisfy the criteria for major bleeding and that leads to either hospital admission for bleeding, physician guided medical or surgical treatment for bleeding or a change in antithrombotic therapy.|Baseline to Week 12|The safety analysis set consisted of all treated participants. Two participants (1 each in the apixaban 2.5 mg BID group and apixaban 5.0 mg BID group) were mistakenly administered warfarin and therefore, included in the warfarin group per the statistical analysis plan.||participants|||Number
779068|NCT00787150|Secondary|Number of Participants With Major (Per International Society on Thrombosis and Haemostasis [ISTH] Criteria) Bleeding Events During the Treatment Period|Major bleeding event is acute clinically overt bleeding accompanied by decrease in hemoglobin of 2 g/dL or more over a 24-hour period, transfusion of 2 or more units of packed red blood cells, or bleeding that occurs in critical site (e.g., intracranial). Fatal bleeding is also major bleeding event.|Baseline to Week 12|The safety analysis set consisted of all treated participants. Two participants (1 each in the apixaban 2.5 mg BID group and apixaban 5.0 mg BID group) were mistakenly administered warfarin and therefore, included in the warfarin group per the statistical analysis plan.||participants|||Number
779069|NCT00787150|Secondary|Number of Participants With Total Bleeding Events During the Treatment Period|Total bleeding events consisted of major (per International Society on Thrombosis and Haemostasis [ISTH] Criteria), clinically relevant non-major and minor bleeding events. All acute clinically overt bleeding events not meeting the criteria for either major bleeding or clinically relevant non-major bleeding were classified as minor bleeding.|Baseline to Week 12|The safety analysis set consisted of all treated participants. Two participants (1 each in the apixaban 2.5 mg BID group and apixaban 5.0 mg BID group) were mistakenly administered warfarin and therefore, included in the warfarin group per the statistical analysis plan.||participants|||Number
779080|NCT00787202|Secondary|Percentage of Participants With Clinical Remission|Clinical remission was defined as a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point. Mayo score:instrument designed to measure disease activity of ulcerative colitis. Total score range: 0 to 12; higher score=more severe disease. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible proctosigmoidoscopy and physician global assessment, each ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe).|Week 8|FAS: all participants who either withdrew as treatment failure TF or completed >=1 week dosing, had >=1 valid Mayo score during active double-blind phase. Participants who withdrew as TF were treated as non-responders. Missing data due to reason other than TF were excluded. N=evaluable participants for the measure.||percentage of participants|||Number
779070|NCT00787150|Primary|Number of Participants With Major (Per International Society on Thrombosis and Haemostasis [ISTH] Criteria) or Clinically Relevant Non-major Bleeding Adjudicated by Clinical Event Committee During the Treatment Period|Major bleeding event was acute clinically overt bleeding accompanied by decrease in hemoglobin of 2 g/dL or more over a 24-hour period, transfusion of 2 or more units of packed red blood cells, or bleeding that occurs in critical site (e.g., intracranial). Fatal bleeding was also major bleeding event. Clinical relevant non-major bleeding was acute or sub-acute clinically overt bleeding that does not satisfy the criteria for major bleeding and that leads to either hospital admission for bleeding, physician guided medical or surgical treatment for bleeding or a change in antithrombotic therapy.|Baseline to Week 12|The safety analysis set consisted of all treated participants. Two participants (1 each in the apixaban 2.5 mg BID group and apixaban 5.0 mg BID group) were mistakenly administered warfarin and therefore, included in the warfarin group per the statistical analysis plan.||participants|||Number
779071|NCT00787189|Secondary|Tinnitus, Hearing-related Quality of Life||up to 6 months||||||
779072|NCT00787189|Primary|Participants Whose Change in Percent Correct Word Recognition Scores From Baseline to One Week After Study Treatment Equalled or Exceeded the Minimum Change in a Reference Chart.|Participants were asked to repeat 50 words presented one at a time through headphones to each ear separately at a comfortable listening level to the participant. The 50 words were from a phonetically-balanced list of monosyllabic words called the CID W-22 lists. The percent of total words repeated correctly for each ear was recorded and the change in this percent from baseline to one week after study treatment was referenced against a chart. If the change was equal to or greater than the corresponding value in the chart, the participant was considered to have a successful study outcome.|baseline and one week|ITT analysis.||participants|||Number
779073|NCT00787202|Secondary|Plasma Concentration of CP-690,550|Summary statistics were calculated for each dose group using the nominal collection times and by setting concentration values below the lower limit of quantification (LLOQ) (LLOQ=0.1 nanogram per milliliter [ng/mL]) to zero.|0.25, 0.5, 1, 2 hours post-dose on Day 1, 0 (pre-dose) and 1 hour post-dose on Week 2, Week 4, 0 (pre-dose), 0.25, 0.5, 1, 2 hours post-dose on Week 8|Analysis population included all participants who had at least 1 plasma concentration. N=evaluable participants for this measure.||ng/mL||Standard Deviation|Mean
779074|NCT00787202|Secondary|Change From Baseline in Level of Fecal Calprotectin at Week 2, 4, 8 and 12|Fecal calprotectin is an inflammatory marker for the gastrointestinal tract and considered as a measurement of neutrophil migration to the gastrointestinal tract. Higher values indicate more serious inflammation.|Baseline, Week 2, 4, 8, 12|FAS: all participants who either withdrew as TF or completed >=1 week of dosing, had >=1 valid Mayo score during active double-blind phase. Missing data were excluded. N=evaluable participants for the measure. n=number of participants at specified time point for each arm group, respectively.||milligram per kilogram (mg/kg)||Standard Deviation|Mean
779075|NCT00787202|Secondary|Change From Baseline in Level of C-Reactive Protein (CRP) at Week 4 and 8|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 4, 8|FAS: all participants who either withdrew as TF or completed >=1 week of dosing, had >=1 valid Mayo score during active double-blind phase. Missing data were excluded. N=evaluable participants for the measure. n=number of participants at specified time point for each arm group, respectively.||milligram per liter (mg/L)||Standard Deviation|Mean
779076|NCT00787202|Secondary|Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 8|IBDQ: Psychometrically validated patient reported outcome (PRO) instrument for measuring disease-specific quality of life (QOL) in participants with IBD. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). Total score is sum of each item score, ranged from 32 to 224 with higher score indicates better QOL. Positive change in total score indicated improvement in QOL.|Baseline, Week 8|FAS: all participants who either withdrew as TF or completed >=1 week of dosing, had >=1 valid Mayo score during active double-blind phase. Missing data were excluded. N=evaluable participants for the measure. n=number of participants at specified time point for each arm group, respectively.||units on a scale||Standard Deviation|Mean
779077|NCT00787202|Secondary|Change From Baseline in Partial Mayo Score at Week 2, 4, 8 and 12|Partial Mayo score was ranged from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores: stool frequency, rectal bleeding and physician's global assessment, each ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe).|Baseline, Week 2, 4, 8, 12|FAS: all participants who either withdrew as TF or completed >=1 week of dosing, had >=1 valid Mayo score during active double-blind phase. Baseline-observation-carried-forward (BOCF) was used for participants who withdrew as TF. Missing data due to reasons other than treatment failure were excluded. N=evaluable participants for the measure.||units on a scale||Standard Deviation|Mean
779078|NCT00787202|Secondary|Percentage of Participants With Endoscopic Remission|Endoscopic remission was defined as the findings of flexible proctosigmoidoscopy subscore of the Mayo score equals 0. Mayo score: instrument designed to measure disease activity of ulcerative colitis. Total score range: 0 to 12; higher score=more severe disease. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible proctosigmoidoscopy and physician global assessment, each ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe).|Week 8|FAS: all participants who either withdrew as treatment failure TF or completed >=1 week dosing, had >=1 valid Mayo score during active double-blind phase. Participants who withdrew as TF were treated as non-responders. Missing data due to reason other than TF were excluded. N=evaluable participants for the measure.||percentage of participants|||Number
779079|NCT00787202|Secondary|Percentage of Participants With Endoscopic Response|Endoscopic response was defined as decrease from baseline in the findings of the flexible proctosigmoidoscopy subscore of the Mayo score at least 1 point. Mayo score: instrument designed to measure disease activity of ulcerative colitis. Total score range: 0 to 12; higher score=more severe disease. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible proctosigmoidoscopy and physician global assessment, each ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe).|Week 8|FAS: all participants who either withdrew as treatment failure TF or completed >=1 week dosing, had >=1 valid Mayo score during active double-blind phase. Participants who withdrew as TF were treated as non-responders. Missing data due to reason other than TF were excluded. N=evaluable participants for the measure.||percentage of participants|||Number
779081|NCT00787202|Primary|Percentage of Participants With Clinical Response|Clinical response was defined as a decrease from baseline in Mayo score of at least 3 points and at least 30 percent, with accompanying decrease in subscore for rectal bleeding of at least 1 point or absolute subscore for rectal bleeding of 0 or 1. Mayo score: instrument designed to measure disease activity of ulcerative colitis. Total score range: 0 to 12; higher score=more severe disease. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible proctosigmoidoscopy and physician global assessment, each ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe).|Week 8|Full analysis set (FAS): all participants who withdrew as treatment failure (TF) or completed >=1 week dosing, had >=1 valid Mayo score during active double-blind phase. Participants who withdrew as TF=non-responders. Missing data due to reason other than TF were excluded. N (number of participants analyzed)=evaluable participants for the measure.||percentage of participants|||Number
779082|NCT00787241|Secondary|Time Interval (Hours) From Closet Platelet Count to Initiation of Neuraxial Analgesia|Time interval in hours from the closest obtained platelet count to the initiation of neuraxial analgesia.|1 week to time of neuraxial analgesia|||Hours||Full Range|Median
779083|NCT00787241|Secondary|Positive Predictive Value of Platelet Count Closet to Neuraxial Analgesia|The positive predictive value of the platelet count closest to neuraxial analgesia with the maintenance of a platelet count greater than 80,000 during labor and delivery and removal of the epidural catheter was calculated. The test was considered true if the closest platelet count was >150,000 platelets and the subsequent platelet counts remained above 80,000 platelets. The number of subjects with a test equal true was divided by the total number of subjects with a platelet counts >150,000 at the closest available platelet count multiplied by 100.|0 to 72 hours following delivery|||percentage of positive platelet counts|||Number
779084|NCT00787241|Primary|Positive Predictive Value of Earliest Available Platelet Count|The positive predictive value of the earliest available platelet count with the maintenance of a platelet count greater than 80,000 during labor and delivery and removal of the epidural catheter was calculated. The test was considered true if the first platelet count was >150,000 platelets and the subsequent platelet counts remained above 80,000 platelets. The number of subjects with a test equal true was divided by the total number of subjects with a platelet counts >150,000 at the earliest available platelet count multiplied by 100.|0 to 72 hours following delivery|||percentage of positive platelet counts|||Number
779085|NCT00787254|Secondary|Number of Participants With Adverse Events|Treatment-emergent adverse events (TEAE) are adverse events with an onset that occurs after receiving study drug. A TEAE may also be a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing. Please see Other Adverse Events table below for TEAE listings.|Per Incidence (up to 24 months).|||participants|||Number
779086|NCT00787254|Secondary|Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 24)|The number of participants that experience hematemesis and melena (blood stool, black stool, tarry stool) at month 24, and number of participants that experience hematemesis and melena at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 24.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
779087|NCT00787254|Secondary|Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 18)|The number of participants that experience hematemesis and melena (blood stool, black stool, tarry stool) at month 18, and number of participants that experience hematemesis and melena at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 18.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
779088|NCT00787254|Secondary|Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 12)|The number of participants that experience hematemesis and melena (blood stool, black stool, tarry stool) at month 12, and number of participants that experience hematemesis and melena at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 12.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
779089|NCT00787254|Secondary|Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 6)|The number of participants that experience hematemesis and melena (blood stool, black stool, tarry stool) at month 6, and number of participants that experience hematemesis and melena at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 6.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
779090|NCT00787254|Secondary|Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 3)|The number of participants that experience hematemesis and melena (blood stool, black stool, tarry stool) at month 3, and number of participants that experience hematemesis and melena at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 3.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
779091|NCT00787254|Secondary|Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 24)|The number of participants that develop anorexia at month 24, and number of participants that develop anorexia at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 24.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
779092|NCT00787254|Secondary|Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 18)|The number of participants that develop anorexia at month 18, and number of participants that develop anorexia at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 18.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
779093|NCT00787254|Secondary|Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 12)|The number of participants that develop anorexia at month 12, and number of participants that develop anorexia at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 12.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
779095|NCT00787254|Secondary|Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 3)|The number of participants that develop anorexia at month 3, and number of participants that develop anorexia at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 3.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
779096|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 24)|The number of participants that develop the feeling of heartburn at month 24, and number of participants that develop the feeling of heartburn at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 24.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
779097|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 18)|The number of participants that develop the feeling of heartburn at month 18, and number of participants that develop the feeling of heartburn at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 18.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
779098|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 12)|The number of participants that develop the feeling of heartburn at month 12, and number of participants that develop the feeling of heartburn at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 12.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
779099|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 6)|The number of participants that develop the feeling of heartburn at month 6, and number of participants that develop the feeling of heartburn at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 6.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
779100|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 3)|The number of participants that develop the feeling of heartburn at month 3, and number of participants that develop the feeling of heartburn at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 3.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
779101|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 24)|The number of participants that develop the feeling of nausea at month 24, and number of participants that develop the feeling of nausea at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 24.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
779102|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 18)|The number of participants that develop the feeling of nausea at month 18, and number of participants that develop the feeling of nausea at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 18.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
779103|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 12)|The number of participants that develop the feeling of nausea at month 12, and number of participants that develop the feeling of nausea at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 12.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
779104|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 6)|The number of participants that develop the feeling of nausea at month 6, and number of participants that develop the feeling of nausea at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 6.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
779105|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 3)|The number of participants that develop the feeling of nausea at month 3, and number of participants that develop the feeling of nausea at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 3.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
779106|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 24)|The number of participants that develop the feeling of an enlarged abdomen at month 24, and number of participants that develop the feeling of an enlarged abdomen at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 24.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
779107|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 18)|The number of participants that develop the feeling of an enlarged abdomen at month 18, and number of participants that develop the feeling of an enlarged abdomen at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 18.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
779108|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 12)|The number of participants that develop the feeling of an enlarged abdomen at month 12, and number of participants that develop the feeling of an enlarged abdomen at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 12.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
779109|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 6)|The number of participants that develop the feeling of an enlarged abdomen at month 6, and number of participants that develop the feeling of an enlarged abdomen at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 6.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
779110|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 3)|The number of participants that develop the feeling of an enlarged abdomen at month 3, and number of participants that develop the feeling of an enlarged abdomen at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 3.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
779111|NCT00787254|Secondary|Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 24)|The number of participants that develop hunger and nighttime pain at month 24, and number of participants that develop hunger and nighttime pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 24.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
779112|NCT00787254|Secondary|Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 18)|The number of participants that develop hunger and nighttime pain at month 18, and number of participants that develop hunger and nighttime pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 18.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
779113|NCT00787254|Secondary|Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 12)|The number of participants that develop hunger and nighttime pain at month 12, and number of participants that develop hunger and nighttime pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 12.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
779114|NCT00787254|Secondary|Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 6)|The number of participants that develop hunger and nighttime pain at month 6, and number of participants that develop hunger and nighttime pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 6.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
779115|NCT00787254|Secondary|Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 3)|The number of participants that develop hunger and nighttime pain at month 3, and number of participants that develop hunger and nighttime pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 3.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
779116|NCT00787254|Secondary|Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 24)|The number of participants that develop postprandial pain at month 24, and number of participants that develop postprandial pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 24.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
779117|NCT00787254|Secondary|Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 18)|The number of participants that develop postprandial pain at month 18, and number of participants that develop postprandial pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 18.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
779118|NCT00787254|Secondary|Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 12)|The number of participants that develop postprandial pain at month 12, and number of participants that develop postprandial pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 12.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
779119|NCT00787254|Secondary|Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 6)|The number of participants that develop postprandial pain at month 6, and number of participants that develop postprandial pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 6.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
779120|NCT00787254|Secondary|Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 3)|The number of participants that develop postprandial pain at month 3, and number of participants that develop postprandial pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 3.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
779121|NCT00787254|Secondary|Number of Participants With Gastric or Duodenal Ulcer or Gastric or Duodenal Hemorrhagic Lesion (Upper Gastrointestinal Hemorrhage)|Number of participants with gastric or duodenal ulcer or gastric or duodenal hemorrhagic lesion (upper gastrointestinal hemorrhage) from baseline through month 24 or final visit. Ulcers are defined as mucosal defect with white coating 3 mm or greater.|On occurrence (up to month 24).|On days where participants did not have an occurrence of gastric or duodenal ulcer or gastric or duodenal hemorrhagic lesion (upper gastrointestinal hemorrhage) and who also underwent endoscopic examination were considered censored dates. Values are from the Full Analysis Set.||participants|||Number
779132|NCT00787254|Primary|Number of Participants With Gastric Ulcer and/or Duodenal Ulcer|The number of participants that developed gastric ulcer and/or duodenal ulcer at month 24 or final visit. Ulcers are defined as mucosal defect with white coating 3 mm or greater.|24 Months|Participants not taking investigational drug were not included.||participants|||Number
779122|NCT00787254|Secondary|Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 24)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.|Baseline and Month 24.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
779123|NCT00787254|Secondary|Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 18)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.|Baseline and Month 18.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
779124|NCT00787254|Secondary|Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.|Baseline and Month 12.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
779125|NCT00787254|Secondary|Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.|Baseline and Month 6.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
779126|NCT00787254|Secondary|Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.|Baseline and Month 3.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
779127|NCT00787254|Secondary|Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 24)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.|Baseline and Month 24.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
779128|NCT00787254|Secondary|Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 18)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.|Baseline and Month 18.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
779129|NCT00787254|Secondary|Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.|Baseline and Month 12.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
779130|NCT00787254|Secondary|Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.|Baseline and Month 6.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
779131|NCT00787254|Secondary|Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.|Baseline and Month 3.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
779135|NCT00787267|Secondary|Grade 3-5 Toxicity Associated With Dasatinib Treatment|Number of subjects with Grade 3-5 toxicity as assessed using NCI CTCAE criteria with the attribution of possibly, probably, or definitely related to protocol treatment.|Duration of dasatinib treatment plus 30 days|All subjects who received at least one dose of dasatinib were included in the analysis.||participants|||Number
779136|NCT00787267|Secondary|Overall Survival|Overall survival (OS) is the duration from date of consent to date of death from any cause.|Progression and survival every 6 months|All subjects who received at least one dose of dasatinib were included in the analysis.||months||95% Confidence Interval|Median
779137|NCT00787267|Primary|Tumor Response|"Tumor response rate was defined by RECIST criteria:
CR (complete response) = disappearance of all target lesions taking as reference the baseline sum of the longest diameter (LD); PR (partial response) = at least a 30% decrease in the sum of the longest diameter of target lesions; PD (progressive disease) = at least a 20% increase in the sum of the longest diameter of target lesions as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; SD (stable disease) = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum LD since the treatment started"|2 years|Unable to determine the response for 9 subjects.||participants|||Number
779138|NCT00787319|Other Pre-specified|Physician's Assessment of Tolerability|Number of participants with each grade of tolerability of treatment as assessed by physician was evaluated on the five point categorical scale: excellent, very good, good, fair, poor.|Baseline up to Week 104 (EOS)|Safety analysis set included all enrolled participants who received study medication.||participants|||Number
779139|NCT00787319|Other Pre-specified|Mean Number of Doses of Study Medication Received||Baseline up to Week 104 (EOS)|Safety analysis set included all enrolled participants who received study medication.||doses||Standard Deviation|Mean
779140|NCT00787319|Other Pre-specified|Duration of Treatment|Duration of treatment (in weeks) was calculated as: (date of the last injection of study medication minus date of the first injection of study medication plus 1) divided by 7.|Baseline up to Week 104 (EOS)|Safety analysis set included all enrolled participants who received study medication.||weeks||Standard Deviation|Mean
779141|NCT00787319|Other Pre-specified|Number of Participants Who Discontinued Treatment Due to Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|Baseline up to Week 104 (EOS)|Safety analysis set included all enrolled participants who received study medication.||participants|||Number
779142|NCT00787319|Other Pre-specified|Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring|Procedures used for diagnosis of AMD and monitoring of the course of treatment included fluorescein angiography (FA), optical coherent tomography (OCT), or other (Ot) procedure apart from FA and OCT. OCT, FA, and other are not mutually exclusive, hence same participant may be included in more than 1 procedure for AMD diagnosis and monitoring at a particular time point.|Baseline, Week 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102|Safety analysis set included all enrolled participants who received study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n' signifies participants evaluated at each time point, respectively.||participants|||Number
779143|NCT00787319|Secondary|Physician's Assessment of Efficacy|Efficacy was based on the study eye for which pegaptanib treatment was given. Number of participants with each grade of efficacy of treatment, as assessed by the physician was reported on the 5 point categorical scale: excellent, very good, good, fair, poor.|Week 104 or End of study (EOS)|FAS included all enrolled participants who received study medication.||participants|||Number
779144|NCT00787319|Secondary|Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination|VA measured as viewing distance (distance for participant/distance for normal vision). Viewing distance considered as fraction to calculate decimal VA. logMAR= -log10 (decimal VA). It measures VA loss; positive values indicated vision loss,negative values denote normal/better VA and allowed comparison of data using different viewing distances and/or different charts(85 or 100 letters, 85 letter equivalents to decimal VA of 1.0). Results based on study eye for which medication was given. Number of participants with VA improved, unchanged or worsened as compared to previous examination reported.|Week 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102|FAS included all enrolled participants who received study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n' signifies participants evaluated at each time point, respectively.||participants|||Number
779145|NCT00787319|Secondary|Change From Baseline in Visual Acuity (VA) at Each Visit|VA measured as viewing distance (distance for participant/distance for normal vision). Viewing distance considered as fraction to calculate decimal VA. Decimal VA data presented as logMAR, logMAR= -log10 (decimal VA). It measures VA loss; positive values indicated vision loss, while negative values denote normal/better VA and allowed comparison of data using different viewing distances and/or different charts (85 or 100 letters, 85 letter equivalents to decimal VA of 1.0). Results were based on study eye for which medication was given.|Baseline, Week 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102|FAS included all enrolled participants who received study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n' signifies participants evaluated at each time point, respectively.||logMAR||Standard Deviation|Mean
779146|NCT00787319|Primary|Change From Baseline in Visual Acuity (VA) at Final Visit|Visual acuity (VA) measured as viewing distance (distance for participant/distance for normal vision). Viewing distance considered as fraction to calculate decimal VA. Decimal VA data presented as Logarithm of Minimum Angle of Resolution (logMAR), logMAR= -log10 (decimal VA). It measures VA loss; positive values indicated vision loss, while negative values denote normal/better VA and allowed comparison of data using different viewing distances and/or different charts (85 or 100 letters, 85 letter equivalents to decimal VA of 1.0). Results were based on study eye for which medication was given.|Baseline, Final Visit (Week 104 or early termination [ET])|Full analysis set (FAS) included all enrolled participants who received study medication. Missing values were imputed using last observation carried forward (LOCF) method.||logMAR||Standard Deviation|Mean
779147|NCT00787332|Primary|New Thrombosis, Amputation, Death, Major and Minor Bleeding||30 days|All patients receiving drug||participants|||Number
792485|NCT00892957|Secondary|Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes||Preoperative baseline through postoperative Day 14|Safety Analysis Data Set||x10^3/µl||Full Range|Median
779148|NCT00787527|Primary|Phase II MTD of Vorinostat|MTD of Vorinostat when administered in combination with Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) defined as highest dose level in which 6 patients have been treated with less than 2 instances of dose limiting toxicity (DLT). Continual reassessment during each 21-day cycle to assess dose limiting toxicity. Two schedules of Vorinostat were investigated: Phase I A) daily doses on days 5 to 14, or Phase II B) three times a day on days -2 to 3 of standard CHOP every 21 days. Vorinostat was administered orally on days 5 to 14 (Schedule A), first at 300 mg orally once daily (total doses of 3000 mg over 10 days per cycle), and next at 200 mg orally twice daily (total doses of 4000 mg over 10 days per cycle); Schedule B Vorinostat administered orally 300 mg orally three times daily from days -2 to 3 (4500 mg over 5 days per cycle).|21 Days|||mg/three times daily|||Number
779149|NCT00787527|Primary|Number of Participants With Dose Limiting Toxicity for Determination Phase I (Schedule A) MTD of Vorinostat|MTD of Vorinostat defined as highest dose level in which 6 patients have been treated with less than 2 instances of DLT. Continual reassessment during each 21-day cycle to assess DLT. Vorinostat was administered orally on days 5 to 14 (Schedule A), first at 300 mg orally once daily (total doses of 3000 mg over 10 days per cycle), and next at 200 mg orally twice daily (total doses of 4000 mg over 10 days per cycle. The dose of Vorinostat escalated in successive 3+3 cohorts of participants to determine the MTD.|21 Days|||participants|||Number
779150|NCT00787527|Primary|Phase I Maximum Tolerated Dose (MTD) of Vorinostat|MTD of Vorinostat when administered in combination with Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) defined as highest dose level in which 6 patients have been treated with less than 2 instances of dose limiting toxicity (DLT). Continual reassessment during each 21-day cycle to assess dose limiting toxicity. Two schedules of Vorinostat were investigated: Phase I A) daily doses on days 5 to 14, or Phase II B) three times a day on days -2 to 3 of standard CHOP every 21 days. Vorinostat was administered orally on days 5 to 14 (Schedule A), first at 300 mg orally once daily (total doses of 3000 mg over 10 days per cycle), and next at 200 mg orally twice daily (total doses of 4000 mg over 10 days per cycle); and for Phase II Schedule B Vorinostat administered orally 300 mg orally three times daily from days -2 to 3 (4500 mg over 5 days per cycle).|21 Days|||mg/day|||Number
779151|NCT00787566|Secondary|Patient Global Satisfaction With Antiemetic Therapy Measured by a VAS|VAS (visual analog scale) 0: not at all satisfied, 100: totally satisfied|24 hours||||||
779152|NCT00787566|Secondary|Severity of Nausea Measured by a 4 Categorical Scale|4 categorical scale: none, mild (did not interfere with normal daily life), moderate (interfered with normal daily life), and severe (bedridden due to nausea/ required the patient to be bedridden)|24 hours||||||
779153|NCT00787566|Secondary|Number of Emetic Episodes||24 hours||||||
779154|NCT00787566|Secondary|Time to Treatment Failure|Time to treatment failure is based on time to first emetic episode or time to rescue medication, whichever occurs first|24 hours||||||
779155|NCT00787566|Secondary|Time to First Rescue Medication||24 hours||||||
779156|NCT00787566|Secondary|Time to First Emetic Episode||24 hours||||||
779157|NCT00787566|Secondary|Percentage of Patients Using Rescue Medications||24 hours||||||
779158|NCT00787566|Secondary|Percentage of Patients With Failure|Failure: > 5 emetic episodes|24 hrs||||||
779159|NCT00787566|Secondary|Percentage of Patients With Minor Control of Emesis|Minor Control of emesis: 3-5 emetic episodes|24 hrs||||||
779160|NCT00787566|Secondary|Percentage of Patients With Major Control of Emesis|Major Control of emesis = 2 emetic episodes|24 hrs||||||
779161|NCT00787566|Secondary|Percentage of Patients With Total Response|Total Response is defined as no nausea, no emetic episodes, and no use of rescue medications|24 hours||||||
779162|NCT00787566|Secondary|Percentage of Patients With Complete Response|Complete Response is defined as no emetic episodes and no use of rescue medications|24 hours||||||
779163|NCT00787566|Primary|Percentage of Patients With Complete Control|Complete Control is defined as no emetic episodes, no use of rescue medications, and no more than mild nausea as defined by a categorial scale.|24 hours|ITT population||Percentage|||Number
779164|NCT00787605|Secondary|Evaluate the Safety and Tolerability|Percentage of patients with Adverse Event and percentage of patients with edema|after 8 weeks of treatment|safety||Percentage of participants|||Number
779165|NCT00787605|Secondary|Biomarker Measurements|Geometric mean of the post to baseline ratio in biomarkers of plasma renin activity (ng/ml/h), plasma renin concentration (ng/L), and cystatin C (mg/L)|Baseline and Week 8|Full analysis set, intent-to-treat||ratio||95% Confidence Interval|Geometric Mean
779166|NCT00787605|Secondary|Percentage of Patients Achieving Blood Pressure Control|Blood pressure control is defined as patient achieving a target Blood Pressure of mean sitting Systolic BloodPressure / mean sitting Diastolic Blood Pressure < 130/80 mmHg.|after 8 weeks of treatment|Full analysis set, intent-to-treat||Percentage of Participants|||Number
779167|NCT00787605|Secondary|Percentage of Responders|Response defined by mean sitting Systolic Blood Pressure < 130 mm Hg or a reduction of mean sitting Systolic Blood Pressure >= 20 mm Hg from baseline|Week 8|Full analysis set, intent-to-treat||Percentage of Participants|||Number
779168|NCT00787605|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)||Baseline and Week 8|Full analysis set, intent-to-treat||mmHg||Standard Error|Least Squares Mean
779169|NCT00787605|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)||Baseline and Week 8|Full analysis set, intent-to-treat||mmHg||Standard Error|Least Squares Mean
779170|NCT00787618|Primary|Cmax of Proellex||48 hours|Study prematurely terminated|||||
779171|NCT00787644|Primary|PC20|"Airway reactivity will be measured with methacholine challenge testing following ATS guidelines.
This is the concentration of methacholine that produces a 20% decrease in lung function (measured by forced expiratory volume in 1 second)"|12 weeks|||mg/ml||Standard Deviation|Median
779172|NCT00778817|Secondary|Number of Patients Exhibiting Decrease in Tumor Size at 48 Weeks|Total number of patients whose tumor size at 48 weeks was smaller than their tumor size recorded at baseline (by any amount).|48 weeks|The analysis population excludes two patients who withdrew from the study before the 6 week assessment.||participants|||Number
779173|NCT00778817|Secondary|Number of Patients Exhibiting Decrease in Tumor Size at 18 Weeks|Total number of patients whose tumor size at 18 weeks was smaller than their tumor size recorded at baseline (by any amount).|18 weeks|The analysis population excludes two patients who withdrew from the study before the 6 week assessment.||participants|||Number
779176|NCT00778817|Secondary|Response at 48 Weeks|"RECIST v1.0 was used to evaluate patient response at each time point. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter (LD) since the treatment started; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Subjects who were unevaluable for response were classified as having 'Unknown response'.
Each patient's 'best response' was the most favorable of all recorded responses across all time points. Proportions of patients with each response as their best response are reported in this outcome."|48 weeks|||percentage of participants|||Number
779177|NCT00778817|Secondary|Response at 18 Weeks|"RECIST v1.0 was used to evaluate patient response at each time point. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter (LD) since the treatment started; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Subjects who were unevaluable for response were classified as having 'Unknown response'.
Each patient's 'best response' was the most favorable of all recorded responses across all time points. Proportions of patients with each response as their best response are reported in this outcome."|18 weeks|||percentage of participants|||Number
779178|NCT00778817|Secondary|Response at 12 Weeks|"RECIST v1.0 was used to evaluate patient response at each time point. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter (LD) since the treatment started; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Subjects who were unevaluable for response were classified as having 'Unknown response'.
Each patient's 'best response' was the most favorable of all recorded responses across all time points. Proportions of patients with each response as their best response are reported in this outcome."|12 weeks|||percentage of participants|||Number
779179|NCT00778817|Secondary|Response at 6 Weeks|"RECIST v1.0 was used to evaluate patient response at each time point. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter (LD) since the treatment started; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Subjects who were unevaluable for response were classified as having 'Unknown response'.
Each patient's 'best response' was the most favorable of all recorded responses across all time points. Proportions of patients with each response as their best response are reported in this outcome."|6 weeks|||percentage of participants|||Number
779180|NCT00778817|Secondary|Best Response Rates|"RECIST v1.0 was used to evaluate patient response at each time point. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter (LD) since the treatment started; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Subjects who were unevaluable for response were classified as having 'Unknown response'.
Each patient's 'best response' was the most favorable of all recorded responses across all time points. Proportions of patients with each response as their best response are reported in this outcome."|Up to 6 months|||percentage of participants|||Number
779181|NCT00778817|Primary|Progression-free Survival Rate at 18 Weeks|Progression-free survival rates were estimated at 6, 12, and 18 weeks by the Kaplan-Meier method. At a given time point, this outcome is defined as the proportion of subjects who had not progressed or died. Disease progression is defined according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Progression is characterized by a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|18 weeks|The analysis population excludes two patients who withdrew from the study before the 6 week assessment.||percentage of participants|||Number
779182|NCT00778817|Primary|Progression-free Survival Rate at 12 Weeks|Progression-free survival rates were estimated at 6, 12, and 18 weeks by the Kaplan-Meier method. At a given time point, this outcome is defined as the proportion of subjects who had not progressed or died. Disease progression is defined according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Progression is characterized by a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|12 weeks|The analysis population excludes two patients who withdrew from the study before the 6 week assessment.||percentage of participants|||Number
779183|NCT00778817|Primary|Progression-free Survival Rate at 6 Weeks|Progression-free survival rates were estimated at 6, 12, and 18 weeks by the Kaplan-Meier method. At a given time point, this outcome is defined as the proportion of subjects who had not progressed or died. Disease progression is defined according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Progression is characterized by a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|6 weeks|The analysis population excludes two patients who withdrew from the study before the 6 week assessment.||percentage of participants|||Number
792486|NCT00892957|Secondary|Laboratory Values Over Time: Erythrocytes||Preoperative baseline through postoperative Day 14|Safety Analysis Data Set||x10^6/µl||Full Range|Median
779184|NCT00778830|Secondary|Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (SAEs), TEAEs Leading to Discontinuation and TEAEs Leading to Death|An Adverse Event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A Serious Adverse Event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|From the start of the trial until disease progression, death or last tumor assessment, reported between day of first subject recruited and until data cut-off date (31 March 2014)|Safety population consisted of all the enrolled subjects who received at least one dose of study treatment.||Subjects|||Number
779185|NCT00778830|Secondary|Overall Survival (OS) Time|OS time was defined as the time from first administration of study drug until date of death, assessed up to 5 years. OS time was censored if the subject was found to be alive on the last date of the assessment.|From the start of the trial until disease progression, death or last tumor assessment, reported between day of first subject recruited and until data cut-off date (31 March 2014)|The ITT population consisted of all the enrolled subjects who received at least one dose of study treatment.||months||95% Confidence Interval|Median
779186|NCT00778830|Secondary|Progression-Free Survival (PFS) Time|PFS time was defined as the time from first administration of study drug until first observation of disease progression or death when death occurs within 90 days of the last tumor assessment or first study drug dose whichever occurred.|From the start of the trial until disease progression, death or last tumor assessment, reported between day of first subject recruited and until data cut-off date (31 March 2014)|The ITT population consisted of all the enrolled subjects who received at least one dose of study treatment.||months||95% Confidence Interval|Median
779187|NCT00778830|Primary|Percentage of Subjects With Best Overall Confirmed Response Rate (BORR)|Response rate was defined as the percentage of subjects with BORR (confirmed complete response [CR] or partial response [PR]) according to Response Evaluation Criteria in Solid Tumors (RECIST version 1.0) criteria. As per RECIST v 1.0 criteria for target lesions and assessed by magnetic resonance imaging (MRI): CR = disappearance of all target lesions; PR = at least 30 percent (%) decrease in the sum of the longest diameter of target lesions. Response rate will be assessed every 8 weeks.|From the start of the trial until disease progression, death or last tumor assessment, reported between day of first subject recruited until data cut-off date (31 May 2012)|Intention-to-treat (ITT) population consisted of all the enrolled subjects who received at least one dose of study treatment.||Percentage of subjects|||Number
779188|NCT00778869|Primary|Number of Genes Which Were Differentially Expressed|Differentially expressed genes were described as those which were at least 1.5 times up- or down-regulated and statistically different at a significance level of 0.05 using a paired t-test comparing 10 ankylosing spondylitis (AS) participants during tumor necrosis factor (TNF) alpha treatment (Remicade) with 10 matched controls. Control samples were previously obtained and not specifically collected for this study.|14 weeks|||Number of genes|||Number
779189|NCT00778895|Secondary|Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination|"SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s) = Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination.
This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol."|During the 6-month safety follow up after vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.||subjects|||Number
779190|NCT00778895|Secondary|Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination|"SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s) = Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination.
This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol."|During the 28-day post-vaccination period|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.||subjects|||Number
779191|NCT00778895|Secondary|Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination|"MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
Analysis of intensity and relationship to vaccination of MAEs was not performed.
This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol."|During the 6-month safety follow up after vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.||subjects|||Number
779192|NCT00778895|Secondary|Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination|"MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
Analysis of intensity and relationship to vaccination of MAEs was not performed.
This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol."|During the 28-day post-vaccination period after vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.||subjects|||Number
779220|NCT00779038|Primary|Number of Participants With Intravenous Administration During Treatment With Fentanyl ITS at End of Study Treatment|Total number of participants who required intravenous administration postoperatively, for treating study treatment related side effect or for additional pain control, during treatment with fentanyl ITS was assessed.|End of Study treatment (Hour 72)|Data was not analyzed because there were insufficient participants to perform a meaningful efficacy analysis due to premature study termination.|||||
779193|NCT00778895|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) After Vaccination|"Unsolicited AEs covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = Occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 = Occurrence of any unsolicited AE that prevented normal, everyday activities. Related = Occurrence of an unsolicited AE assessed by the investigator to be causally related to study vaccination.
This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol."|During the 28-day follow-up period (Days 0-27) after vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.||subjects|||Number
779194|NCT00778895|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination|"Symptoms assessed were drowsiness, irritability, loss of appetite and fever. Any was defined as occurrence of any general symptom regardless of their intensity grade or relationship to vaccination. Any fever = Axillary temperature ≥ 38.0 degrees Celsius (°C). Grade 3 fever = Axillary temperature ≥ 39.0°C. For other symptoms, grade 3 was defined as an adverse event which prevented normal everyday activities. Related = A general symptom assessed by the investigator as causally related to vaccination.
This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol."|During the 4-day follow-up period (Days 0-3) after any vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and symptom sheet completed.||subjects|||Number
779195|NCT00778895|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination|"Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported regardless of intensity grade. Grade 3 pain = Cried when limb was moved/spontaneously painful. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeters (mm).
This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol."|During the 4-day follow-up period (Days 0-3) after any vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and symptom sheet completed.||subjects|||Number
779196|NCT00778895|Secondary|Seroconversion Factor for HI Antibodies|"The seroconversion factor (SCF) was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination (at Day 28 for primed subjects and at Day 56 for unprimed subjects) compared to pre-vaccination (Day 0).
The flu strains assessed were the A/Brisbane (H1N1), A/Uruguay (H3N2) and B/Florida."|At Day 28 (for primed subjects) and at Day 56 (for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||fold increase||95% Confidence Interval|Geometric Mean
779197|NCT00778895|Secondary|Number of Subjects Seroprotected Against HI Antibodies|"A seroprotected subject was defined as a vaccinated subject with serum HI titer ≥ 1:40.
The flu strains assessed were the A/Brisbane (H1N1), A/Uruguay (H3N2) and B/Florida."|At Day 0 [PRE] and at Day 28 (for primed subjects) and at Day 56 (for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||subjects|||Number
779198|NCT00778895|Secondary|Number of Subjects Seroconverted to HI Antibodies|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The flu strains assessed were the A/Brisbane (H1N1), A/Uruguay (H3N2) and B/Florida.|At Day 28 (for primed subjects) and at Day 56 (for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||subjects|||Number
779199|NCT00778895|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies|Titers are presented as geometric mean titers (GMTs). The reference cut-off value was the seropositivity cut-off of 1:10. Antibodies assessed were antibodies against the A/Brisbane (H1N1), A/Uruguay (H3N2) and B/Florida flu strains.|At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Titer||95% Confidence Interval|Geometric Mean
779200|NCT00778895|Primary|Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination|"SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s) = Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination.
This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol."|During the 6-month safety follow up after vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.||subjects|||Number
779201|NCT00778895|Primary|Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination|"SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s) = Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination.
This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol."|During the 28-day post-vaccination period|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.||subjects|||Number
779202|NCT00778895|Primary|Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination|"MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
Analysis of intensity and relationship to vaccination of MAEs was not performed.
This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol."|During the 6-month safety follow up after vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.||subjects|||Number
779203|NCT00778895|Primary|Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination|"MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
Analysis of intensity and relationship to vaccination of MAEs was not performed.
This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol."|During the 28-day post-vaccination period|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.||subjects|||Number
779204|NCT00778895|Primary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) After Vaccination|Unsolicited AEs covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = Occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 = Occurrence of any unsolicited AE that prevented normal, everyday activities. Related = Occurrence of an unsolicited AE assessed by the investigator to be causally related to study vaccination. This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.|During the 28-day follow-up period (Days 0-27) after vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.||subjects|||Number
779205|NCT00778895|Primary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination|Symptoms assessed were drowsiness, irritability, loss of appetite and fever. Any was defined as occurrence of any general symptom regardless of their intensity grade or relationship to vaccination. Any fever = Axillary temperature ≥ 38.0 degrees Celsius (°C). Grade 3 fever = Axillary temperature ≥ 39.0°C. For other symptoms, grade 3 was defined as an adverse event which prevented normal everyday activities. Related = A general symptom assessed by the investigator as causally related to vaccination. This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.|During the 4-day follow-up period (Days 0-3) after any vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and symptom sheet completed.||subjects|||Number
779206|NCT00778895|Primary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported regardless of intensity grade. Grade 3 pain = Cried when limb was moved/spontaneously painful. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeters (mm). This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.|During the 4-day follow-up period (Days 0-3) after any vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and symptom sheet completed.||subjects|||Number
779207|NCT00778921|Secondary|Biomarker Assessment at Visit 2 (Single Blind Run in), Visit 5 (Randomization), and Visit 9 (EOS)||12 weeks||||||
779208|NCT00778921|Secondary|Number of Patients With Any Adverse Event and/or Serious Adverse Event in the Double-blind Period by Treatment Group||8 weeks|Analysis: Intention to Treat (ITT) Imputation Technique: Last Observation Carried Forward (LOCF)||Participants|||Number
779209|NCT00778921|Secondary|Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study||Baseline and Week 8|full analysis set||mm Hg||Standard Error|Least Squares Mean
779210|NCT00778921|Primary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study||Baseline and Week 8|full analysis set||mm Hg||Standard Error|Least Squares Mean
779211|NCT00778999|Secondary|Number of Good Quality Embryos|This is not a prespecified key secondary outcome; therefore, results will not be disclosed.|12 weeks||||||
779212|NCT00778999|Secondary|Number of Fertilized (2PN) Oocytes|This is not a prespecified key secondary outcome; therefore, results will not be disclosed.|12 weeks||||||
779213|NCT00778999|Secondary|Number of Follicles on Day of hCG|This is not a prespecified key secondary outcome; therefore, results will not be disclosed.|12 weeks||||||
779214|NCT00778999|Secondary|Number of Follicles on Stimulation Day 8|This is not a prespecified key secondary outcome; therefore, results will not be disclosed.|12 weeks||||||
779215|NCT00778999|Secondary|Number of Mature Oocytes|This is not a prespecified key secondary outcome; therefore, results will not be disclosed.|12 weeks||||||
779216|NCT00778999|Primary|Total Number of Oocytes|The total number of oocytes on the Day of oocyte pick-up is an indication of ovarian response|12 weeks|Intent-to-treat, defined as all randomized subjects who received recombinant follicle stimulating hormone||Number of oocytes||Standard Deviation|Mean
779217|NCT00779025|Secondary|Number of Sensations Experienced by Female Subjects - Overall|Number of sensations experienced by female subjects, based on two applications of the product for each subject.|1 Week|Intention to Treat||Sensations|Participants||Number
779218|NCT00779025|Secondary|Number of Sensations Experienced by Male Subjects - Overall|Number of sensations experienced by male subjects, based on two applications of the investigational product.|1 Week|||Sensations|Participants||Number
779219|NCT00779025|Primary|Number of Participants Showing Change From Baseline in Irritation Scores|Number of participants showing change in irritation scores based on physical examinations of both male and female subjects according to a 6-point scale, ranging from 0=Normal appearance, no irritation to 6 = Presence of Lesions|1 week|Analysis was per Intention to Treat (ITT)||Participants|||Number
792487|NCT00892957|Secondary|Laboratory Values Over Time: Hematocrit||Preoperative baseline through postoperative Day 14|Safety Analysis Data Set||percentage of red blood cells in blood||Full Range|Median
779221|NCT00779038|Primary|Number of Participants With Intravenous Administration During Treatment With Fentanyl ITS at Hour 48|Total number of participants who required intravenous administration postoperatively, for treating study treatment related side effect or for additional pain control, during treatment with fentanyl ITS was assessed.|Hour 48|Data was not analyzed because there were insufficient participants to perform a meaningful efficacy analysis due to premature study termination.|||||
779222|NCT00779038|Secondary|Number of Participants With Physician Global Assessment of Method of Pain Control|"The physician global assessment was based on categorical evaluation (poor, fair, good or excellent) for the method of pain control by asking following question from the Physicians: Overall, would you rate this method of pain control as being poor, fair, good, or excellent?"|Hour 72 or early withdrawal|Data was not analyzed because there were insufficient participants to perform a meaningful efficacy analysis due to premature study termination.|||||
779223|NCT00779038|Secondary|Number of Participants With Nurse Global Assessment of Method of Pain Control|"The nurse global assessment was based on categorical evaluation (poor, fair, good or excellent) for the method of pain control by asking following question from the nurses: Overall, would you rate this method of pain control as being poor, fair, good, or excellent?"|Hour 72 or early withdrawal|Data was not analyzed because there were insufficient participants to perform a meaningful efficacy analysis due to premature study termination.|||||
779224|NCT00779038|Secondary|Number of Participants With Patient Global Assessment (PGA) of Method of Pain Control|The PGA was based on categorical evaluation (poor, fair, good or excellent) for the method of pain control by asking following question from the participants: “Overall, would you rate this method of pain control as being poor, fair, good, or excellent?”|Hour 72 or early withdrawal|Data was not analyzed because there were insufficient participants to perform a meaningful efficacy analysis due to premature study termination.|||||
779225|NCT00779038|Primary|Number of Participants With Intravenous Administration During Treatment With Fentanyl Iontophoretic Transdermal System (ITS) at Hour 24|Total number of participants who required intravenous administration (when medicine is given directly into a vein) postoperatively, for treating study treatment related side effect or for additional pain control, during treatment with fentanyl ITS was assessed.|Hour 24|Data was not analyzed because there were insufficient participants to perform a meaningful efficacy analysis due to premature study termination.|||||
779226|NCT00779116|Primary|Number of Subjects Who Preferred Desloratadine RediTab or Zyrtec Chewable Tablet.|"A product preference questionnaire was completed after the administration of the second study drug. An interviewer instructed the subject now that you have tasted the two tablets, show us which tablet you like more and the subject then marked which tablet he/she preferred. If the subject had no preference, the response was recorded accordingly."|Following the second dose (8-10 minutes after the first dose)|All randomized subjects received either Reditab or Zyrtec, followed 8-10 minutes later by the opposite study drug (Reditab followed by Zyrtec or Zyrtec followed by Reditab).||Participants|||Number
779227|NCT00779142|Secondary|Secondary Would be Significant Clinical Improvement (Judged at the Slit Lamp Exam Using a 90D Lens) in Macular Edema at the End of One Month After the Last Intraocular Injection.||1 month||||||
779228|NCT00779142|Secondary|Secondary Would be Increase in Visual Acutiy (VA) Two Lines or More at the End of One Month After the Last Intraocular Injection.||1 month||||||
779229|NCT00779142|Primary|Primary Would be 30% Decrease in One Subfield Thickness on Optical Coherence Tomography (OCT) 4 Weeks After the Last Intraocular Injection||4 weeks|||participants|||Number
779230|NCT00779155|Primary|"Change From Baseline to Study End Point in the Combined Scores From the UPDRS Subscale II and III Recorded in the Subjects on State."|The UPDRS is used to measure different aspects of Parkinson's Disease (PD). The UPDRS subscale II assesses how PD affects a person's daily life, with scores ranging from 0-52, with 52 representing greatest severity. The UPDRS subscale III assesses how PD affects how a person moves about, with scores ranging from 0-108, with 108 representing greatest severity. The combination of these 2 scores is used in clinical trials and in clinical practice to get a good overall idea of how PD affects a person's life. Combined score ranges from 0-160, with 160 being greatest severity.|Baseline and 8 weeks|Analysis was by intention to treat and all enrolled subjects completed the entire protocol.||scores on a scale||Standard Deviation|Mean
779231|NCT00779246|Secondary|Vancomycin Resistant Enterococcal Infection or Colonization||During ICU stay||||||
779232|NCT00779246|Secondary|Central Line Associated Bloodstream Infection||During ICU stay||||||
779233|NCT00779246|Primary|Acquisition of Methicillin-resistant Staph Aureus (MRSA) Colonization or Infection|Number of patients who acquired MRSA by the time of ICU discharge (based on nasal swab or clinical culture).|During ICU stay|For this observational study, subjects were considered at risk for MRSA acquisition if they had no prior history of MRSA, did not have an MRSA infection that was present on admission, and had an ICU length of stay of at least 48 hours.||participants|||Number
779234|NCT00779259|Secondary|Electrocardiogram (ECG) Evaluation of the Maximum QT Interval Corrected for Heartrate (QTc), Theophylline Co-administered With Quinine, Study Day 12.|The QT interval assesses cardiac repolarization and risk for arrhythmias. It is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. QTc is the QT interval corrected for heartrate.|5 hours - measured 1 hour pre-dose and then at 4 hours post-dose on Day 12|||msec|||Number
779235|NCT00779259|Secondary|Electrocardiogram (ECG) Evaluation of the Maximum QT Interval Corrected for Heartrate (QTc), Quinine Study Day 11.|The QT interval assesses cardiac repolarization and risk for arrhythmias. It is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. QTc is the QT interval corrected for heartrate.|5 hours - measured 1 hour pre-dose and then at 4 hours after the morning dose on Day 11|||msec|||Number
779236|NCT00779259|Primary|Area Under the Concentration Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)].|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞)was calculated as the sum of the AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|Serial pharmacokinetic blood samples for theophylline collected on Days 1 and 12 before dosing and for 48 hours post-dose.|A total of 24 healthy adult male subjects participated in this study, 22 of whom completed. Pharmacokinetic analyses of theophylline are based on 19 subjects (data for 2 subjects excluded due to vomiting post-dose and for 1 subject as an outlier. Pharmacokinetic analyses of quinine are based on 20 subjects (excluding the two who vomited).||ug-hr/mL||Standard Deviation|Mean
779237|NCT00779259|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve beginning from the first dose (time 0) to the last measurable concentration (time t), as calculated by the linear trapezoidal method.|Serial pharmacokinetic blood samples for theophylline collected on Days 1 and 12 before dosing and for 48 hours post-dose. Serial pharmacokinetic blood samples for quinine collected on Days 11 and 12 before dosing and for 8 hours after the morning dose.|A total of 24 healthy adult male subjects participated in this study, 22 of whom completed. Pharmacokinetic analyses of theophylline are based on 19 subjects (data for 2 subjects excluded due to vomiting post-dose and for 1 subject as an outlier. Pharmacokinetic analyses of quinine are based on 20 subjects (excluding the two who vomited).||ug-hr/mL||Standard Deviation|Mean
779238|NCT00779259|Primary|Maximum Plasma Concentration(Cmax)|The maximum or peak concentration that the drug reaches in the plasma.|Serial pharmacokinetic blood samples for theophylline collected on Days 1 and 12 before dosing and for 48 hours post-dose. Serial pharmacokinetic blood samples for quinine collected on Days 11 and 12 before dosing and for 8 hours after the morning dose.|A total of 24 healthy adult male subjects participated in this study, 22 of whom completed. Pharmacokinetic analyses of theophylline are based on 19 subjects (data for 2 subjects excluded due to vomiting post-dose and for 1 subject as an outlier. Pharmacokinetic analyses of quinine are based on 20 subjects (excluding the two who vomited).||ug/mL||Standard Deviation|Mean
779239|NCT00779285|Primary|Cardiac Events|A cardiac event was defined as a decrease in left ventricular ejection fraction (LVEF) of >=20 points from baseline if the resting LVEF remained in the normal range, or a decrease of >=10 points if the LVEF became abnormal (lower than the institutional lower limit of normal).|Every 4 weeks during 6 cycles.|||Cardiac Events|||Number
779240|NCT00779311|Secondary|Determination of Quality of Life (QoL) as Indicated by Patient Care Monitor (PCM) Data Among Patients on This Regimen|The subject answers questions from the following 6 categories: general physical symptoms, treatment side effects, distress, despair, impaired performance, and impaired ambulation. Each question has a scale from 0 through 10, where 0 is not a problem and 10 is as bad as possible. The frequency of patient reported severe (rated as >=7) symptoms reported from the set of symptoms assessed by the PCM.|The PCM questionnaire was administered on day 1 of each cycle (approximately every 2 weeks) during study treatment.|The number of patients out of the total sample of 8 patients who reported severe (rated as >=7) symptoms as assessed by the PCM. Symptoms with 0 patients reporting severe symptoms have been omitted.||Participants|||Number
779241|NCT00779311|Secondary|Determination of Progression Free Survival (PFS) Among Patients on This Regimen|PFS is defined as the duration of time from start of treatment to time of progression or death, whichever comes first.|PFS was measured from day 1 of treatment until time of progression (assessed every 8 weeks) or death, whichever came first.|||Months||95% Confidence Interval|Median
779242|NCT00779311|Primary|Determination of the Maximum Tolerated Dose (MTD) of Sorafenib When Given in Combination With mFOLFOX6 and Bevacizumab|The MTD of sorafenib was determined using a standard 3 + 3 dose escalation cohort design. The total sample and the number of patients who receive each dose depends on the frequency of dose limiting toxicities (DLT) at each dosage. If 0 out of 3 patients experience a DLT at a given dosage level, 3 patients will be enrolled at the next dosage level. If greater than or equal to 2 patients experience a DLT at a given dosage level, dosage escalation will be stopped. If 1 out of 3 patients experience a DLT at a given dosage level, 3 patients are enrolled at the same dosage level.|MTD was assessed during the first 2 cycles of treatment (i.e., the first 4 weeks of treatment since cycle length is 2 weeks)|3 patients (pts) were enrolled at DL 1 with 1/3 experiencing DLT, so 3 additional pts were enrolled at DL 1. 2 of those additional pts were not evaluable for DLT assessment and were replaced. 2 more pts were enrolled for a total of 8 pts, and 1 of these pts experienced a DLT. All of the 8 pts enrolled received sorafenib at DL 1.||mg every other day|||Number
779243|NCT00779467|Secondary|Cesarean Delivery|percentage of subjects in each group requiring a ceserean delivery|occurence|||percentage of subjects in each group|||Number
779244|NCT00779467|Secondary|Patient Satisfaction Scores|maternal reported satisfaction scores of labor analgesia on a scale of 1-5, with 1-not satisfied at all up to 5 -completely satisfied with labor analgesia|within 24 hours post delivery|||units on a scale||Inter-Quartile Range|Median
779245|NCT00779467|Secondary|Bromage Score|the incidence of decreased motor block (Bromage score) documented until delivery. Bromage is defined as 0-freely able to move extremities (no motor block) up to 3-unable to move legs or feet (complete motor block)|until delivery|Bromage is defined as 0-freely able to move extremities (no motor block) up to 3-unable to move legs or feet (complete motor block)||units on a scale||Standard Deviation|Mean
779246|NCT00779467|Secondary|Pruritus|the occurrence of pruritis (itching) throughout the labor analgesia infusion--the presence of itching rated on a scale of 0-no itching at all up to a maximum of 10- severe itching.|until delivery|the presence of itching rated on a scale of 0-no itching at all up to a maximum of 10- severe itching.||units on a scale||Standard Deviation|Mean
779247|NCT00779467|Secondary|Shivering|maternal occurrence of shivering--Shivering scored on a 0-no shivering at all up to maximum of 10-shivering uncontrollably|until delivery|||units on a scale||Standard Deviation|Mean
779248|NCT00779467|Secondary|Sedation|average maternal sedation score measured on a 0-not sleepy at all up to a maximum of 10-extremely sleepy|until delivery|||units on a scale||Standard Deviation|Mean
779249|NCT00779467|Secondary|Nausea|average maximum nausea score in each group--maternal nausea scored on a 0-no nausea at all up to maximum of 10-worst nausea imaginable|until delivery|||units on a scale||Standard Deviation|Mean
779250|NCT00779467|Primary|Amount of Drug Consumed Per Hour in Each Group(Arm)|Median hourly total bupivacaine consumption. Drug amount consumed per hour of each group (arm)|until delivery|median hourly total bupivacaine consumption in each group, in ml/hr||milliliters per hour||Inter-Quartile Range|Median
779251|NCT00779506|Secondary|Global Assessment of Functioning (GAF) Score|To improve functional capability in acute schizophrenic patients by evaluation of the change from baseline to Day 57 in GAF scale score, a single-item rating scale for evaluating the overall functioning on a continuum from psychologic or psychiatric sickness to health.|From baseline to Day 57|The MITT set was used for primary analyses (89) participants||score on a scale||Standard Deviation|Mean
780234|NCT00794118|Primary|Patient Global Assessment (PtGA) of Disease Activity Score at Month 3|PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad.|Month 3|ITT population included all participants who received at least 1 dose of the study medication.||cm||Standard Deviation|Mean
779252|NCT00779506|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|To treat depressive symptoms in acute schizophrenic patients by evaluation of the change from baseline to day 67 in MADRS total score, a 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0-6 scale, higher MADRS scores indicate higher levels of depressive symptoms.|From baseline to Day 57|The MITT set was used for primary analyses (89) participants||score on a scale||Standard Deviation|Mean
779253|NCT00779506|Secondary|Clinical Global Impression (CGI) Score|The Clinical Global Impression – Severity (CGI-S) and – illness (CGI-I) is used in this study. The CGI-S is scored to rate the patient’s current clinical state. The CGI-I is scored to rate the patient’s change from baseline CGI. Each CGI item is scored on a scale from 1 to 7 (CGI-S: 1 = Normal, not ill, 7= Among the most extremely ill patients/ CGI-I: 1= very much improved, 7= very much worse). CGI-I scores greater than 4 indicate worsening, while scores less than 4 indicate improvement|From baseline to Day 57|The MITT set was used for primary analyses (89) participants||score on a scale||Standard Deviation|Mean
779254|NCT00779506|Secondary|Positive and Negative Syndrome Scale (PANSS) General Psychopathology Score|To evaluate the change of general psychopathology symptoms from baseline to Day 57 in PANSS general score, a 16-item scale where each symptom is rated on a severity scale ranging from 1 (absent) to - 7 (extreme)|From baseline to Day 57|The MITT set was used for primary analyses (89) participants||score on a scale||Standard Deviation|Mean
779255|NCT00779506|Secondary|Positive and Negative Syndrome Scale (PANSS) Negative Score|To evaluate the change of negative symptoms from baseline to Day 57 in PANSS negative score, a 7-item scale where each symptom is rated on a severity scale ranging from 1 (absent) - 7 (extreme)|From baseline to Day 57|The MITT set was used for primary analyses (89) participants||score on a scale||Standard Deviation|Mean
779256|NCT00779506|Secondary|Positive and Negative Syndrome Scale (PANSS) Positive Score|To evaluate the change of positive symptoms from baseline to Day 57 in PANSS positive score, a 7-item scale where eash symptom is rated on a severity scale ranging from 1 (absent) - 7 (extreme)|From baseline to Day 57|The MITT set was used for primary analyses (89) participants||score on a scale||Standard Deviation|Mean
779257|NCT00779506|Primary|The Change in Positive and Negative Syndrome Scale(PANSS)Total Score|"PANSS, a 30-item scale where each symptom is rated on a severity scale ranging from 1 (absent) - 7 (extreme), total score is 30 – 210.
Description of the reporting Groups: Evaluate the efficacy of Quetiapine XR with daily dose 400 mg - 800 mg used as mono-therapy in the treatment of acute schizophrenic patients by evaluation of the change from baseline to Day 57 in total score of PANSS using the last observation carried forward (LOCF) method"|From baseline to Day 57|The MITT set was used for primary analyses (89) participants||score on a scale||Standard Deviation|Mean
779258|NCT00779558|Secondary|Need for Antibiotics||While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)|||participants|||Number
779259|NCT00779558|Secondary|Cardiac ICU Length of Stay||While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)|||days||Standard Deviation|Mean
779260|NCT00779558|Secondary|Days to Extubation||While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)|||days||Standard Deviation|Mean
779261|NCT00779558|Secondary|Total PRBCs Transfused||While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)|||mL/kg||Standard Deviation|Mean
779262|NCT00779558|Primary|Thrombosis|Echocardiographic evidence of thrombosis while on study drug|While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first). Echoes were performed after 24-48 hours and then every 3-5 days|||participants|||Number
779263|NCT00779584|Secondary|MK-8776 Terminal Phase Half-Life (t1/2)|The t1/2 of MK-8776 was assessed in Cycle 0 and in Cycle 1. On Day 1 of Cycle 0 and Cycle 1, plasma samples were obtained from all participants before infusion, at end of infusion of MK-8776 (Cycle 0) or gemcitabine (Cycle 1), and at 0.25, 1, 3, 6, 8, 24 and 48 hours after completion of MK-8776 infusion.|At end of infusion of MK-8776 (Cycle 0) or gemcitabine (Cycle 1), and at 0.25, 1, 3, 6, 8, 24 and 48 hours after completion of MK-8776 infusion|The population consisted of all participants who received at least two cycles of study treatment.||hr||Standard Deviation|Mean
779264|NCT00779584|Secondary|Time of MK-8776 Cmax (Tmax)|The time of Cmax of MK-8776 was assessed in Cycle 0 and in Cycle 1. On Day 1 of Cycle 0 and Cycle 1, plasma samples were obtained from all participants before infusion, at end of infusion of MK-8776 (Cycle 0) or gemcitabine (Cycle 1), and at 0.25, 1, 3, 6, 8, 24 and 48 hours after completion of MK-8776 infusion.|At end of infusion of MK-8776 (Cycle 0) or gemcitabine (Cycle 1), and at 0.25, 1, 3, 6, 8, 24 and 48 hours after completion of MK-8776 infusion|The population consisted of all participants who received at least two cycles of study treatment.||hr||Standard Deviation|Mean
779265|NCT00779584|Secondary|MK-8776 Area Under the Curve of the Plasma Concentration Versus Time From Time Zero to the Time of the Last Analytically Quantifiable Concentration (AUC0-last)|AUC0-last was assessed in Cycle 0 and in Cycle 1. On Day 1 of Cycle 0 and Cycle 1, plasma samples were obtained from all participants before infusion, at end of infusion of MK-8776 (Cycle 0) or gemcitabine (Cycle 1), and at 0.25, 1, 3, 6, 8, 24 and 48 hours after completion of MK-8776 infusion. AUC0-last was calculated by the linear trapezoidal method.|At end of infusion of MK-8776 (Cycle 0) or gemcitabine (Cycle 1), and at 0.25, 1, 3, 6, 8, 24 and 48 hours after completion of MK-8776 infusion|The population consisted of all participants who received at least two cycles of study treatment.||ng*hr/mL||Standard Deviation|Mean
779266|NCT00779584|Secondary|MK-8776 Maximum Plasma Concentration (Cmax)|The Cmax of MK-8776 was assessed in Cycle 0 and in Cycle 1. On Day 1 of Cycle 0 and Cycle 1, plasma samples were obtained from all participants before infusion, at end of infusion of MK-8776 (Cycle 0) or gemcitabine (Cycle 1), and at 0.25, 1, 3, 6, 8, 24 and 48 hours after completion of MK-8776 infusion.|At end of infusion of MK-8776 (Cycle 0) or gemcitabine (Cycle 1), and at 0.25, 1, 3, 6, 8, 24 and 48 hours after completion of MK-8776 infusion|The population consisted of all participants who received at least two cycles of study treatment.||ng/mL||Standard Deviation|Mean
779377|NCT00787761|Primary|Achievement of > 90% (Full) Donor Chimerism in the T-cell Lineage as Measured by PCR at Day 30 Post-transplantation|Chimerism analysis of peripheral blood mononuclear cells using PCR for STR/VNTR will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism.|Day 30|only 15 of the patients treated on study had Day 30 chimerism results.||participants|||Number
779267|NCT00779584|Primary|Number of Participants Who Discontinued Study Treatment Due to an AE|An AE was defined as any untoward medical occurrence in a participant administered study treatment which did not necessarily have to have a causal relationship with this treatment. An AE could have been any unfavorable and unintended sign (e.g. an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to study treatment. The number of participants who discontinued study treatment due to an AE is presented.|Up to approximatey 66 weeks|The population consisted of all participants who received at least one dose of MK-8776.||Participants|||Number
779268|NCT00779584|Primary|Number of Participants Who Experienced an Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a participant administered study treatment which did not necessarily have to have a causal relationship with this treatment. An AE could have been any unfavorable and unintended sign (e.g. an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to study treatment. The number of participants who experienced an AE is presented.|Up to approximately 72 weeks (Up to approximately 6 weeks after last dose of study treatment)|The population consisted of all participants who received at least one dose of MK-8776.||Participants|||Number
779269|NCT00779584|Primary|Number of Participants Who Experienced a Dose-limiting Toxicity (DLT) During Cycle 0 and Cycle 1 Based on National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v 3.0)|During Cycle 0, a DLT was defined as: CTCAE v 3.0 Grade 3 neutropenia or thrombocytopenia lasting ≥3 days; any CTCAE v 3.0 Grade 4 neutropenia or thrombocytopenia; neutropenic fever; any CTCAE v. 3.0 ≥ Grade 3 QT interval corrected by Fridericia (QTcF) prolongation of any duration; any other CTCAE v 3.0 Grade 3 or higher nonhematologic toxicity; or Grade 3 elevation of transaminases that resolved prior to administration of next dose(s) of study drug(s); delay in Cycle 1 Day 1 beyond 3 weeks due to continuing toxicity. During Cycle 1, a DLT was defined as: CTCAE v 3.0 Grade 4 neutropenia that persists for ≥7 days; neutropenic fever; CTCAE v 3.0 Grade 4 thrombocytopenia; CTCAE v 3.0 ≥ Grade 3 thrombocytopenia with bleeding; any CTCAE v 3.0 QTc ≥ Grade 3 QTcF prolongation of any duration; any other CTCAE v 3.0 Grade 3 or higher nonhematologic toxicity; or Grade 3 elevation of transaminases that resolved prior to administration of next dose(s) of study drug(s).|Through Cycle 0 and Cycle 1 (Up to 42 days)|The population consisted of all participants who were evaluable for DLT assessment (i.e., completed Cycle 0 and Cycle 1).||Participants|||Number
779270|NCT00779675|Secondary|Number of Participants Who Achieved a PASI-75 Response at Week 50 by PASI Score at Baseline|Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-75 response was defined as >=75% improvement in overall PASI score when compared to baseline..|Week 50|The Efficacy Population includes all participants with a baseline PASI score within 14 days of the time of the first infusion and at least one post-baseline PASI score.||Participants|||Number
779271|NCT00779675|Secondary|Number of Participants Who Achieved a PASI-75 Response at Week 50 by the Presence of Nail Psoriasis at Baseline|Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-75 response was defined as >=75% improvement in overall PASI score when compared to baseline.|Week 50|The Efficacy Population includes all participants with a baseline PASI score within 14 days of the time of the first infusion and at least one post-baseline PASI score.||Participants|||Number
779272|NCT00779675|Secondary|Number of Participants Who Achieved a PASI-75 Response at Week 50 by Race|Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-75 response was defined as >=75% improvement in overall PASI score when compared to baseline.|Week 50|The Efficacy Population includes all participants with a baseline PASI score within 14 days of the time of the first infusion and at least one post-baseline PASI score.||Participants|||Number
779295|NCT00779766|Secondary|Number of Subjects With Medically Significant Conditions Regardless of Causal Relationship to Vaccination and Intensity for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline|Medically significant conditions were defined as: adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.|up to Months 24 and 72|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
779378|NCT00787787|Secondary|Median Overall Survival|Survival estimated by Kaplan-Meier method|From start of treatment until death from any cause, assessed up to 3 years|||days||Full Range|Median
779273|NCT00779675|Secondary|Number of Participants Who Achieved a PASI-75 Response at Week 50 by Gender|Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-75 response was defined as >=75% improvement in overall PASI score when compared to baseline.|Week 50|The Efficacy Population includes all participants with a baseline PASI score within 14 days of the time of the first infusion and at least one post-baseline PASI score.||Participants|||Number
779274|NCT00779675|Secondary|Number of Participants Who Achieved a PASI-75 Response at Week 50 by Age|Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-75 response was defined as >=75% improvement in overall PASI score when compared to baseline.|Week 50|The Efficacy Population includes all participants with a baseline PASI score within 14 days of the time of the first infusion and at least one post-baseline PASI score.||Participants|||Number
779275|NCT00779675|Secondary|Number of Participants With a PASI-50, PASI-75, PASI-90, or PASI-100 Response at Week 98|Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-50, PASI-75, PASI-90, and PASI-100 response were defined as >=25%, >=50%, >=75%, >=90%, =100% improvement in PASI score versus baseline, respectively.|Week 98|The population consisted of participants who were in the efficacy population of the treatment phase and who entered into the extended treatment phase with at least one PASI evaluation during the extended treatment phase.||Participants|||Number
779276|NCT00779675|Secondary|Number of Participants With A DLQI Score of 0 or 1 in the Extended Treatment Phase|The DLQI assesses the impact of psoriasis on the participants's daily life. DLQI total score comprises 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. DLQI total scores range from 0 to 30, with 0 corresponding to the best quality of life and 30 to the worst with 0-1=no effect on the partipant's life, 2-5=small effect on the participant's life, 6-10= moderate effect on the participant's life, 11=20= very large effect on participant's life, and 21-30 = extremely large effect on participant's life.|Week 50, Week 62, Week 78, Week 98|The population consisted of all participants with a DLQI measurement at each time point.||Participants|||Number
779277|NCT00779675|Secondary|Change From Baseline in Mean Dermatology Life Quality Index (DLQI)|The DLQI assesses the impact of psoriasis on the participants's daily life. DLQI total score comprises 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. DLQI total scores range from 0 to 30, with 0 corresponding to the best quality of life and 30 to the worst with 0-1=no effect on the partipant's life, 2-5=small effect on the participant's life, 6-10= moderate effect on the participant's life, 11=20= very large effect on participant's life, and 21-30 = extremely large effect on participant's life.|Baseline, Week 50, Week 62, Week 78, Week 98|The population consisted of all participants with a DLQI measurement at baseline and at each time point.||Score on a Scale||Standard Error|Mean
779278|NCT00779675|Secondary|Number of Participants With a PASI-90 or PASI-75 Response at Week 98 Among Participants Who Had a PASI-75 Response at Week 50 and Who Entered the Extended Treatment Phase|PASI socres were used to measure the severity and extent of psoriasis. Using a scale of 0=nonoe to 4=very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness, and scaling of the largest psoriatic area in that region; thse 4 totals (ranging from 0 to 16) are then multipled by the standardized percentage of total body area that region represents (head=0.1 of body surface area, trunk=0.2 of body surface area, arms=0.3 of body surface area, and legs=0.4 of body surface area). An assessment is then made of the percentage of area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-90 and PASI-75 response were defined at >=90% and >=75% improvement in overall PASI score when compared to baselne, respectively.|Week 98|The population consisted of participants who were in the efficacy population of the treatment phase and who entered into the extended treatment phase and had a PASI-75 response at Week 50 with at least one PASI evaluation during the extended treatment phase.||Participants|||Number
779440|NCT00791492|Secondary|Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration at Week 6, Month 3, 6 and 12|NT-proBNP was biomarker of cardiac stress (myocardial necrosis and increased filling pressures/ LV wall stress).|Baseline, Week 6, Month 3, 6, 12|Safety population included participants who received at least one dose of study medication. 'N' (number of participants analyzed) signifies participants evaluable for this measure. ‘n’ signifies participants evaluable for this measure at the specified time point for each arm group.||picogram/milliliter (pg/mL)||Full Range|Median
779279|NCT00779675|Secondary|Change From Baseline in Mean PASI Score|Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. Decreasing scores are indicative of improvement in overall PASI score.|Baseline, Week 14, Week 30, Week 50, Week 62, Week 78, Week 98|The population consists of all participants with a baseline PASI score and a subsequent score at Week 14, 30, 50, 62, 78,and 98.||Score on a Scale||95% Confidence Interval|Mean
779280|NCT00779675|Secondary|Number of Participants With a PASI-90, PASI-75, or PASI-50 Response at Week 98 Among Participants With a PASI-50 Response at Week 50 and Who Entered the Extended Treatment Period|Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-50, PASI-75, and PASI-90 response were defined as >=50%, >=75%, >=90% improvement in PASI score versus baseline, respectively.|Week 98|The population includes all participants that achieved PASI-50 response at Week 50 and entered the extended treatment phase.||Participants|||Number
779281|NCT00779675|Secondary|Number of Participants With a PASI-90 Response at Week 98 Among Participants With a PASI-90 Response at Week 50 and Who Entered the Extended Treatment Period|Participant PSAI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4=very severe, each body region (head, trunk, arms, and legs) is rate for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each regon represents (head=0.1 of body surface area, trunk=0.2 of body surface area, arms=0.3 of body surface area, legs=0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multipled by the subtotal of the body area of that region; the four region scores are then added to produce the total PASI score. PSAI-90 response was defined as >=90% improvement in overall PASI score when compared to baseline.|Week 98|The population consists of all participants that achieved PASI-90 response at Week 50 and entered the extended treatment phase.||Participants|||Number
779282|NCT00779675|Secondary|Number of Participants With a PASI-90, PASI-75, or PASI-50 Response at Week 50 Among Participants With a PASI-50 Response at Week 14|Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-50, PASI-75, and PASI-90 response were defined as >=50%, >=75%, >=90% improvement in PASI score versus baseline.|Week 50|The population includes all participants that achieved a PASI-50 response at treatment Week 14.||Participants|||Number
779283|NCT00779675|Secondary|Number of Particpants With a PASI-90 or PASI-75 at Week 50 Among Participants With a PASI-75 Response at Week 14|Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-90 and PASI-75 response were defined as >=90% improvement and a >=75% improvement, respectively, in overall PASI score when compared to baseline.|Week 50|The population consists of all participants that achieved PASI-75 response by treatment Week 14.||Participants|||Number
779284|NCT00779675|Secondary|Number of Participants With a PASI-90 Response at Week 50 Among Participants With a PASI-90 Response at Week 14|Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-90 response was defined as >= 90% improvement when compared to baseline.|Week 50|The population consists of all participants that achieved a PASI-90 response at treatment Week 14.||Participants|||Number
780029|NCT00784134|Secondary|Intensity of Critical Care Management - Shunts|Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.|30 days|All patients that were enrolled in CLEAR III were analyzed.||% of participants with shunts|||Number
779285|NCT00779675|Primary|Number of Participants With a Psoriasis Area Sensitivity Index (PASI)-75 Response at Week 50|Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-75 response was defined as >=75% improvement in overall PASI score when compared to baseline.|Week 50|The Efficacy Population includes all participants with a baseline PASI score within 14 days of the time of the first infusion and at least one post-baseline PASI score.||Participants|||Number
779286|NCT00779701|Primary|Time to Achieve Glycemic Control||Study duration 6 hours. Blood glucose checked at 30 minutes then every 15 minutes until within target blood glucose range then every hour.|||Minutes||Standard Deviation|Mean
779287|NCT00779766|Secondary|Number of Subjects With Pregnancies and Their Outcomes for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline|Outcomes of pregnancies were Live infant NO ACA, Live infant CA, Premature live infant NO ACA, Elective termination NO ACA, Elective termination CA, Therapeutic abortion, Ectopic pregnancy, Spontaneous abortion NO ACA, Spontaneous abortion CA, Stillbirth NO ACA, Stillbirth CA, Lost to follow up, Molar pregnancy, Pregnancy ongoing. For some categories it was specified if the infant presents congenital anomaly (CA) or no apparent congenital anomaly (No ACA).|up to Months 24 and 72|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
779288|NCT00779766|Secondary|Number of Subjects With Pregnancies and Their Outcomes Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline|Outcomes of pregnancies were Live infant NO ACA, Live infant CA, Premature live infant NO ACA, Elective termination NO ACA, Therapeutic abortion, Ectopic pregnancy, Spontaneous abortion NO ACA, Spontaneous abortion CA, Stillbirth NO ACA, Stillbirth CA, Lost to follow up, Molar pregnancy, Pregnancy ongoing. For some categories it was specified if the infant presents congenital anomaly (CA) or no apparent congenital anomaly (No ACA).|up to Months 24 and 72|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
779289|NCT00779766|Secondary|Number of Subjects With Pregnancies and Their Outcomes for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline|Outcomes of pregnancies were Live infant NO ACA, Premature live infant NO ACA, Elective termination NO ACA, Elective termination CA, Therapeutic abortion, Ectopic pregnancy, Spontaneous abortion NO ACA, Spontaneous abortion CA, Stillbirth CA, Lost to follow up, Molar pregnancy, Pregnancy ongoing. For some categories it was specified if the infant presents congenital anomaly (CA) or no apparent congenital anomaly (No ACA).|up to Months 24 and 72|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
779290|NCT00779766|Secondary|Number of Subjects With Pregnancies and Their Outcomes|"Outcomes of pregnancies were Live infant NO ACA, Premature live infant NO ACA, Elective termination NO ACA, Therapeutic abortion, Ectopic pregnancy, Spontaneous abortion NO ACA, Spontaneous abortion CA, Stillbirth congenital anomaly, Lost to follow up, Molar pregnancy and Pregnancy ongoing.
For some categories it was specified if the infant presents congenital anomaly (CA) or no apparent congenital anomaly (No ACA)."|up to Months 72|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
779291|NCT00779766|Secondary|Number of Subjects With Unsolicited Adverse Events for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within Days 0-29 after vaccination|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
779292|NCT00779766|Secondary|Number of Subjects With Unsolicited Adverse Events for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms|Within Days 0-29 after vaccination|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
779293|NCT00779766|Secondary|Number of Subjects With Unsolicited Adverse Events for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within Days 0-29 after vaccination|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
779294|NCT00779766|Secondary|Number (%) of Subjects With Medically Significant Conditions Regardless of Causal Relationship to Vaccination and Intensity for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline|Medically significant conditions were defined as: adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.|up to Months 24 and 72|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
780534|NCT00789074|Secondary|Change in Pre-quit Cotinine Levels|Differences in baseline cotinine levels were compared with cotinine levels measured 4 weeks after taking the first medication dose.|Weeks 1-4 (the first 4-weeks after first medication dose)|All participants that provided data at all time points||ng/ml||Standard Deviation|Mean
779296|NCT00779766|Secondary|Number of Subjects With Medically Significant Conditions Regardless of Causal Relationship to Vaccination and Intensity for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline.|Medically significant conditions were defined as: adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.|up to Months 24 and 72|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
779297|NCT00779766|Secondary|Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline|"Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, urticaria and fever (= axillary temperature above 37.0°C).
Any = any solicited general symptom reported irrespective of intensity grade and relationship to vaccination Related = symptoms assessed by the investigator as causally related to study vaccination Grade 3 symptoms = symptoms that prevented normal activity Grade 3 urticaria = urticaria distributed on at least 4 body areas"|Within 7 days (Days 0-6) after vaccination|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
779298|NCT00779766|Secondary|Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline|"Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, urticaria and fever (= axillary temperature above 37.0°C).
Any = any solicited general symptom reported irrespective of intensity grade and relationship to vaccination Related = symptoms assessed by the investigator as causally related to study vaccination Grade 3 symptoms = symptoms that prevented normal activity Grade 3 urticaria = urticaria distributed on at least 4 body areas"|Within 7 days (Days 0-6) after vaccination|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
779299|NCT00779766|Secondary|Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline|"Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, urticaria and fever (= axillary temperature above 37.0°C).
Any = any solicited general symptom reported irrespective of intensity grade and relationship to vaccination Related = symptoms assessed by the investigator as causally related to study vaccination Grade 3 symptoms = symptoms that prevented normal activity"|Within 7 days (Days 0-6) after vaccination|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
779300|NCT00779766|Secondary|Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline|Solicited local symptoms assessed were pain, redness and swelling. Any = solicited local symptom reported irrespective of intensity grade Grade 3 Redness, Swelling = redness/swelling above 50 millimeter All local symptoms were considered as related to the study vaccination|Within 7 days (Days 0-6) after vaccination|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
779301|NCT00779766|Secondary|Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline|Solicited local symptoms assessed were pain, redness and swelling. Any = solicited local symptom reported irrespective of intensity grade Grade 3 Pain = pain that prevented normal activity All local symptoms were considered as related to the study vaccination|Within 7 days (Days 0-6) after vaccination|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
779302|NCT00779766|Secondary|Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline|Solicited local symptoms assessed were pain, redness and swelling. Any = solicited local symptom reported irrespective of intensity grade Grade 3 Pain = pain that prevented normal activity Grade 3 Redness, Swelling = redness/swelling above 50 millimeter All local symptoms were considered as related to the study vaccination|Within 7 days (Days 0-6) after vaccination|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
779303|NCT00779766|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|up to Months 72|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
779304|NCT00779766|Secondary|Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Unsolicited Adverse Events (AEs)|"An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Related = event assessed by the investigator as causally related to study vaccination Grade 3 = event that prevented normal activity"|Within Days 0-29 after vaccination|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
779305|NCT00779766|Secondary|Number of Subjects With Medically Significant Conditions Regardless of Causal Relationship to Vaccination and Intensity.|Medically significant conditions were defined as: adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.|up to Months 24 and 72|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
779524|NCT00791778|Other Pre-specified|FOSI Total Score at Cycle 3|The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The FOSI total score ranges from 0 (severely symptomatic) to 32 (asymptomatic).|At Cycle 3 (4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 3||Scores on a scale||Standard Deviation|Mean
779306|NCT00779766|Secondary|Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.|"Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, urticaria and fever (= axillary temperature above 37.0 degrees Celsius).
Any = any solicited general symptom reported irrespective of intensity grade and relationship to vaccination Related = symptoms assessed by the investigator as causally related to study vaccination Grade 3 symptoms = prevented normal activity Grade 3 urticaria = distributed on at least 4 body areas"|Within 7 days (Days 0-6) after vaccination|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
779307|NCT00779766|Secondary|Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling. Any = solicited local symptom reported irrespective of intensity grade Grade 3 Pain = pain that prevented normal activity Grade 3 Swelling = swelling above 50 millimeter All local symptoms were considered as related to the study vaccination|Within 7 days (Days 0-6) after vaccination|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
779308|NCT00779766|Secondary|Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status|"Titers were expressed as geometric mean titers calculated on all subjects HPV-16 assay cut-off value was defined as greater than or equal to 8 ELISA units per millilitre (EL.U/mL) at Months 0, 7, 12 and 24 and greater than or equal to 19 ELISA units per millilitre (EL.U/mL) at Months 36, 48 and 72.
HPV-18 assay cut-off value was defined as greater than or equal to 7 ELISA units per millilitre (EL.U/mL) at Month 0, 7, 12 and 24 and greater than or equal to 18 ELISA units per millilitre (EL.U/mL) at Months 36, 48 and 72..
Seronegative (Sero-) subjects are subjects who had an antibody concentration below the assay cut-off value prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration equal to or above the assay cut-off value prior to vaccination."|at Months 0 (PRE), 7, 12, 24, 36, 48 and 72|The According-To-Protocol cohort for immunogenicity for the interim analysis included only data up to Month 7 of subjects from the immunogenicity subset (795 subjects recruited exclusively from one site). This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.||Titers||95% Confidence Interval|Geometric Mean
779309|NCT00779766|Secondary|Number of Subjects With HPV-18 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status|HPV-18 assay cut-off value was defined as greater than or equal to 7 ELISA units per millilitre (EL.U/mL) at PRE vaccination, Month 7, 12 and 24 and greater than or equal to 18 ELISA units per millilitre (EL.U/mL) at Month 36, 48 and 72. Seronegative (Sero-) subjects are subjects who had an antibody concentration below 7 EL.U/mL and 18 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration equal to or above 7 EL.U/mL and 18 EL.U/mL prior to vaccination.|at Months 0 (PRE), 7, 12, 24, 36, 48 and 72|The According-To-Protocol cohort for immunogenicity for the interim analysis included only data up to Month 7 of subjects from the immunogenicity subset (795 subjects recruited exclusively from one site). This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.||Subjects|||Number
779310|NCT00779766|Secondary|Number of Subjects With HPV-16 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status|HPV-16 assay cut-off value was defined as greater than or equal to 8 ELISA units per millilitre (EL.U/mL) at PRE vaccination, Month 7, 12 and 24 and greater than or equal to 19 ELISA units per millilitre (EL.U/mL) at Month 36, 48 and 72. Seronegative (Sero-) subjects are subjects who had an antibody concentration below 8 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration equal to or above 8 EL.U/mL prior to vaccination.|at Months 0 (PRE), 7, 12, 24, 36, 48 and 72|The According-To-Protocol cohort for immunogenicity for the interim analysis included only data up to Month 7 of subjects from the immunogenicity subset (795 subjects recruited exclusively from one site). This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.||Subjects|||Number
779311|NCT00779766|Secondary|Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type|"CIN2+ = CIN grades 2 and 3, LCGIN, HCGIN, AIS or invasive cervical cancer. Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 individually or in combination. Subjects were HPV DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus.
HRW-HPV=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68."|At Months 24, 48, 57 and 72|The According-To-Protocol cohort for efficacy included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0.||Subjects|||Number
779312|NCT00779766|Secondary|Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type|"CIN1+ = CIN grades 1, 2 and 3, LCGIN, HCGIN, AIS or invasive cervical cancer. Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 individually or in combination. Subjects were HPV DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus.
HRW-HPV=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68."|At Months 24, 48, 57 and 72|The According-To-Protocol cohort for efficacy included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0.||Subjects|||Number
779313|NCT00779766|Secondary|Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection|CIN2+ = CIN grades 2 and 3, LCGIN, HCGIN, AIS or invasive cervical cancer. DNA- and sero-: subjects HPV DNA negative at Months 0 and 6 by PCR and seronegative at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA) Overall: subjects DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus.|At Months 24, 48, 57 and 72|The According-To-Protocol cohort for efficacy included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0.||Subjects|||Number
779314|NCT00779766|Secondary|Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection|"CIN1+ = CIN grades 1, 2, and3, low-grade cervical glandular intraepithelial neoplasia (LCGIN), high grade cervical glandular intraepithelial neoplasia (HCGIN), adenocarcinoma in-situ (AIS) or invasive cervical cancer.
DNA- and sero-: subjects HPV DNA negative at Months 0 and 6 by PCR and seronegative at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA) Overall: subjects DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus."|At Months 24, 48, 57 and 72|The According-To-Protocol cohort for efficacy included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0.||Subjects|||Number
779315|NCT00779766|Secondary|Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type|"Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-US).
Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 individually or in combination. Subjects were HPV DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus.
HRW-HPV=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68."|At Months 24, 48, 57 and 72|The According-To-Protocol cohort for efficacy included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0.||Subjects|||Number
779316|NCT00779766|Secondary|Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection|"Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-DNA- and sero-: subjects HPV DNA negative at Months 0 and 6 by PCR and seronegative at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA) Overall: subjects DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus.
US)."|At Months 24, 48, 57 and 72|The According-To-Protocol cohort for efficacy included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0.||Subjects|||Number
779317|NCT00779766|Secondary|Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type|"Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 individually or in combination. Subjects were HPV DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus.
HRW-HPV=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68."|At Months 24,48, 57 and 72|The According-To-Protocol cohort for efficacy included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0.||Subjects|||Number
779318|NCT00779766|Secondary|Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type|"Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 individually or in combination. Subjects were HPV DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus.
HRW-HPV=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68."|At Months 24, 48, 57 and 72|The According-To-Protocol cohort for efficacy included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0.||Subjects|||Number
779319|NCT00779766|Secondary|Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type|"Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 individually or in combination. Subjects were HPV DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus.
HRW-HPV=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68."|At Months 24, 48, 57 and 72|The According-To-Protocol cohort for efficacy included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0.||Subjects|||Number
779320|NCT00779766|Secondary|Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18|"Persistent infection (12-month+ definition) is defined as the detection of the same HPV type(s) (by PCR) in cervical samples at all available time points over an interval of approximately 12 months.
Subjects had at least 10 months of follow-up after Month 12. DNA- and sero-: subjects HPV DNA negative at Months 0 and 6 by PCR and seronegative at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA).
Overall: subjects DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus."|At Months 24, 48, 57 and 72|The According-To-Protocol cohort for efficacy included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0.||Subjects|||Number
779357|NCT00780455|Secondary|Number of Participants With Fatigue Based on Participants Self Assessment Using the Fatigue Severity Scale (FSS)|FSS is an auto-questionnaire estimating the fatigue. It includes 9 questions on 7 points as well as an analogical visual scale estimating the state of fatigue over the last two weeks. Participants had the following two types of visit during the study, one visit with a neurologist and one visit with a rehabilitation physician. Visit to a neurologist: V0=baseline; V1=end of Month 1 of treatment; V2=end of Month 2 of treatment; V3=end of Month 3 of treatment. Visit to MR (Medecin Reeducateur: physician for rehabilitation): MR1=1st visit within 15 days after V0; MR2=2nd visit (6 weeks after MR1 +/- 1 week); MR3=end of study visit 12 weeks after MR1.|From baseline to 12 weeks after MR1 visit|Due to the very low number of patients enrolled in the study, no statistical report was done.|||||
779321|NCT00779766|Secondary|Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18|"Persistent HPV-16 and/or HPV-18 infection (6-month+ definition) = at least 2 positive HPV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assays for the same viral genotype with no negative DNA sample between the two positive DNA samples, over an interval of approximately 6 months.
Subjects had at least 5 months of follow-up after Month 12. DNA- and sero-: subjects HPV DNA negative at Months 0 and 6 by PCR and seronegative at Month 0 for the corresponding HPV-type by ELISA Overall: subjects DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus."|At Months 24, 48, 57 and 72|The According-To-Protocol cohort for efficacy included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0.||Subjects|||Number
779322|NCT00779766|Secondary|Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18|"HPV-16 and/or HPV-18 incident infection is defined as at least one positive HPV-16 or HPV-18 DNA PCR assay at the time point considered.
DNA- and sero-: subjects HPV DNA negative at Months 0 and 6 by PCR and seronegative at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA)
Overall: subjects DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus."|At Months 24,48, 57 and 72|The According-To-Protocol cohort for efficacy included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0.||Subjects|||Number
779323|NCT00779766|Primary|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18|"CIN1+ = CIN 1, 2, and 3, low/high-grade cervical glandular intraepithelial neoplasia (L/HCGIN), adenocarcinoma in-situ (AIS) or invasive cervical cancer.
Persistent infection (6-month+ definition) = at least 2 positive HPV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assays for the same viral genotype with no negative DNA sample between the 2 positive DNA samples, over an interval of approximately 6 months. The analyses were done on subjects HPV DNA negative at Months 0 and 6 and seronegative at Month 0 or on subjects DNA- at Months 0 and 6, regardless of initial serostatus."|At Months 24, 48, 57 and 72|The According-To-Protocol cohort for efficacy included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0.||Subjects|||Number
779324|NCT00779779|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject|Throughout the study period (Day 0 to Month 3 or 4)|Analysis was performed on the Total Vaccinated Cohort, which consisted of all vaccinated subjects with at least one vaccine administration documented.||subjects|||Number
779325|NCT00779779|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited AEs cover any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31-day follow-up period|Analysis was performed on the Total Vaccinated Cohort, which consisted of all vaccinated subjects with at least one vaccine administration documented.||subjects|||Number
779326|NCT00779779|Secondary|Number of Subjects Reporting Each Type of Solicited General Symptoms|Solicited symptoms included cough, diarrhoea, irritability, loss of appetite, fever (degrees Celsius) and vomiting.|During the 8-day follow-up period|Analysis was performed on the Total Vaccinated Cohort, which consisted of all vaccinated subjects with at least one vaccine administration documented.||subjects|||Number
779327|NCT00779779|Primary|"Number of Subjects With at Least One >= Grade 2 Fever, Vomiting or Diarrhoea"|"Grade 2 fever was defined as axillary temperature > 38.0 to <= 39.0 degrees Celsius and grade 3 fever as axillary temperature > 39.0 degrees Celsius.
Grade 2 vomiting was defined as 2 episodes of vomiting per day and grade 3 as 3 or more episodes of vomiting per day.
Grade 2 diarrhoea was defined as 4-5 looser than normal stools per day and grade 3 as 6 or more looser than normal stools a day."|During the 8-day solicited follow-up period|Analysis was performed on the Total Vaccinated Cohort, which consisted of all vaccinated subjects with at least one vaccine administration documented.||subjects|||Number
779328|NCT00779857|Primary|Percent of Patients With Complete Occlusion of the Left Atrial Appendage.|The primary efficacy endpoint is defined as the complete exclusion of the LAA defined by lack of fluid communication between the LA and LAA at both intra-operative (TEE) and 3 month (CT) evaluations and intra-operative verification of completeness of LAA exclusion.|3 Months Post Procedure|The primary analysis population for the efficacy endpoint is all patients enrolled into the trial who complete the intended treatment and the required post procedure and follow-up efficacy endpoint assessments (completers). All available data, regardless of whether data are derived within specified time windows, will be included in this analysis.||percentage of subjects||95% Confidence Interval|Number
779329|NCT00779857|Primary|Rate of Device Related Serious Adverse Events|The primary safety endpoint is the rate of device related serious adverse events within 30 days post-procedure or hospital discharge, whichever is later, compared with the rates for serious adverse events for LAA exclusion reported in the peer review literature. The safety endpoint was determined based on an independent review of all reported adverse events by an independent cardiac surgeon that was not an investigator in the study.|Discharge/30 days Post Procedure|The primary analysis population is all patients enrolled in the trial. All available data, regardless of whether data are derived within specified time windows will be included in the analysis. Patients who do not complete the entire course of treatment will be included.||Number of participants||95% Confidence Interval|Number
779330|NCT00779909|Secondary|Urinary Calcium/Creatinine Ratio|Urinary calcium ratios were calculated from urine samples at week 4, 7, and 12. A normal reference interval for the urine calcium (mg/dL):urine creatinine (mg/dL) ratio is <0.14.|week 4, week 7, week 12|||ratio||Standard Deviation|Mean
779331|NCT00779909|Secondary|Serum Calcium|The serum calcium blood test measures the total calcium in the participants' blood. The normal range for total serum calcium concentration in adults is 8.9-10.2 mg/dL.|week 7, week 12|||mg/dl||Standard Deviation|Mean
779332|NCT00779909|Secondary|Gingival Crevicular Fluid (GCF) Concentrations of TNF-alpha, IL1-beta, IL-2, IL-12|"GCF will be collected by placing a filter paper strip at the opening of the gingival crevice. After carefully removing the supragingival plaque from the sampling area, a paper strip will be placed for 30s or until visibly wet. Sampling time will be recorded and GCF volume collected with each sample will be quantified using a Periotron device.
GCF volume will be sampled from three mesial sites per subject: The upper left central incisor, the first upper left premolar and the first upper left molar. Should any of these teeth be missing, substitution will occur in the following order (i) the contralateral tooth, (ii) the distally adjacent tooth, or (iii) the distally adjacent tooth of the contralateral tooth. Should a sample be visibly contaminated with blood, the sample will be discarded and substitution will occur as described above. Concentrations of TNF-alpha, IL-1 beta, IL-2, and IL-12 will be measured and means and SDs will be calculated for each study arm."|week 8 and week 12|||pg/site||Standard Deviation|Mean
779333|NCT00779909|Secondary|Gingival Crevicular Fluid (GCF) Volume|GCF will be collected by placing a filter paper strip at the opening of the gingival crevice. After carefully removing the supragingival plaque from the sampling area, a paper strip will be placed for 30s or until visibly wet. Sampling time will be recorded and GCF volume collected with each sample will be quantified using a Periotron device. GCF volume will be sampled from three mesial sites per subject: The upper left central incisor, the first upper left premolar and the first upper left molar. Should any of these teeth be missing, substitution will occur in the following order (i) the contralateral tooth, (ii) the distally adjacent tooth, or (iii) the distally adjacent tooth of the contralateral tooth. Should a sample be visibly contaminated with blood, the sample will be discarded and substitution will occur as described above.|week 8 and week 12|||ul||Standard Deviation|Mean
779334|NCT00779909|Secondary|Maxillary Plaque Index (PI) Score|The Turesky plaque index was used. In this index, plaque is identified using a disclosing solution and scored using a 0 to 5 scale in which a score of 0= No plaque, 1= Separate flecks of plaque, 2= continuous band of plaque less or equal 1 mm, 3= Continuous band of plaque greater than 1 mm but less than 1/3 of crown height, 4= Continuous band of plaque greater or equal 1/3 but less or equal 2/3 of crown height, and 5= Continuous band of plaque greater 2/3 of crown height. Each tooth receives 6 individual scores at: mesial, middle, and distal scores for both the facial and lingual surfaces. An individual’s score is derived by adding the scores at each site and dividing by the number of sites evaluated. Higher scores denote higher plaque accumulation. Lower scores are more favorable.|week 8 and week 12|||units on a scale||Standard Deviation|Mean
779335|NCT00779909|Secondary|Mandibular Plaque Index (PI) Score|The Turesky plaque index was used. In this index, plaque is identified using a disclosing solution and scored using a 0 to 5 scale in which a score of 0= No plaque, 1= Separate flecks of plaque, 2= continuous band of plaque less or equal 1 mm, 3= Continuous band of plaque greater than 1 mm but less than 1/3 of crown height, 4= Continuous band of plaque greater or equal 1/3 but less or equal 2/3 of crown height, and 5= Continuous band of plaque greater 2/3 of crown height. Each tooth receives 6 individual scores at: mesial, middle, and distal scores for both the facial and lingual surfaces. An individual’s score is derived by adding the scores at each site and dividing by the number of sites evaluated. Higher scores denote higher plaque accumulation. Lower scores are more favorable.|week 8 and week 12|||units on a scale||Standard Deviation|Mean
779336|NCT00779909|Primary|Maxillary Modified Gingival Index (MGI) Score|The Modified Gingival Index (MGI) uses non-invasive/no probing and rates mild and moderate inflammation where: 0 = absence of inflammation; 1 = mild inflammation or with slight changes in color and texture but not in all portions of gingival marginal or papillary; 2 = mild inflammation, such as the preceding criteria, in all portions of gingival marginal or papillary; 3 = moderate, bright surface inflammation, erythema, edema and/or hypertrophy of gingival marginal or papillary; 4 = severe inflammation: erythema, edema and/or marginal gingival hypertrophy of the unit or spontaneous bleeding, papillary, congestion or ulceration. The MGI can be obtained by adding the values of each tooth and dividing by the number of teeth examined. The MGI may be scored for all surfaces of all or selected teeth or for selected areas of all or selected teeth. A score from 0.1-1.0 = mild inflammation; 1.1-2.0 = moderate inflammation from, and 2.1-3.0 signifies severe inflammation.|week 8 and week 12|||units on a scale||Standard Deviation|Mean
779337|NCT00779909|Primary|Mandibular Modified Gingival Index (MGI) Score|The Modified Gingival Index (MGI) uses non-invasive/no probing and rates mild and moderate inflammation where: 0 = absence of inflammation; 1 = mild inflammation or with slight changes in color and texture but not in all portions of gingival marginal or papillary; 2 = mild inflammation, such as the preceding criteria, in all portions of gingival marginal or papillary; 3 = moderate, bright surface inflammation, erythema, edema and/or hypertrophy of gingival marginal or papillary; 4 = severe inflammation: erythema, edema and/or marginal gingival hypertrophy of the unit or spontaneous bleeding, papillary, congestion or ulceration. The MGI can be obtained by adding the values of each tooth and dividing by the number of teeth examined. The MGI may be scored for all surfaces of all or selected teeth or for selected areas of all or selected teeth. A score from 0.1-1.0 = mild inflammation; 1.1-2.0 = moderate inflammation from, and 2.1-3.0 signifies severe inflammation.|week 8 and week 12|||units on a scale||Standard Deviation|Mean
779338|NCT00779909|Primary|Proportion of Sites That Bleed on Probing|Assessment of the bleeding index will be performed on oral and buccal sites. The periodontal probe will be moved gently across the marginal gingiva of all teeth of a quadrant. After 30 seconds, absence or presence of bleeding will be scored. The number of bleeding sites is used to calculate the gingival bleeding score.|end of 4 week experimental gingivitis phase|Data for this outcome measure was not collected on any of the participants as it was overlooked and failure to collect these data did not come to the attention of the PI until after all follow-ups were completed.|||||
779339|NCT00780273|Primary|Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level|Incidence of greater than 2 mm crestal bone (mesial or distal) loss. Reported in the percentage of analyzed implants.|24 months after surgery|||Percentage of implants|Participants||Number
779340|NCT00780273|Primary|Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level|Incidence of greater than 2 mm crestal bone (mesial or distal) loss. Reported in the percentage of analyzed implants.|12 months after surgery|||Percentage of implants|Participants||Number
779341|NCT00780273|Primary|Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level|Incidence of greater than 2 mm crestal bone (mesial or distal) loss. Reported in the percentage of analyzed implants.|6 months after surgery|||Percentage of implants|Participants||Number
779342|NCT00780338|Secondary|Prevention Performance - Total Score (Percent Change)|A structured interview was used to assess the impact of AGTO on prevention practitioners' performance of tasks associated with high-quality prevention. Using the interview responses, a set of ratings were made assessing performance of activities in seven key domains: goals and objectives, best practices, planning, process evaluation, outcome evaluation, continuous quality improvement, and sustainability. The ratings are made on 10 items (or “components”) that assess how well each of the above mentioned activities are performed over the last year. Each component has seven response choices, described with specific, observable behaviors, that range from “highly faithful=7” to “highly divergent=1” from ideal performance. The total score is an average of the 10 components, and has the same range as the individual components (“highly faithful=7” to “highly divergent=1” from ideal performance)|baseline, baseline to mid (1 year), mid to posttest (2 years)|Whole programs are rated, not individuals, because programs operate as a unit. Percent change was calculated from Pre to Mid, Mid to Post, PRE to POST.||percent change||Full Range|Mean
779343|NCT00780338|Secondary|Prevention Capacity - Assets Efficacy (User vs Non-user Analyses)|"The Assets efficacy scale is the sum of 10 items using a three-point scale (1=“would need a great deal of help to carry out this task”, 2=“could carry out this task, but would need some help”, 3=“could carry out this task without any help”) asking about activities associated with doing assets activities. The sum was then transformed to be on a 1–100% scale. A percentage point change is equivalent to a .02 change on the original 1–3 scale. A 50-percentage point change would be equivalent to a one-point change on the original 1–3 scale. Same analysis/measure as the intent to treat, but instead just comparing users of AGTO to non-users within the AGTO assigned group. Use was determined by six items added to the Mid and Post Coalition Survey, called the AGTO Participation Index. If individuals received any hours of technical assistance, they received an additional point on the Index."|Baseline, Mid (1 year), Post (2 years)|"Users had a AGTO Participation Index >=1 at either Mid or Post; Non Users had a AGTO Participation Index = 0"||percentage of the highest possible score||Standard Error|Least Squares Mean
779344|NCT00780338|Primary|Prevention Capacity-Assets Efficacy (Intent to Treat)|Assessed in the Coalition Survey, prevention capacity was defined as efficacy and behaviors of practitioners. Assets efficacy scale is the sum of 10 items using a three-point scale (1=“would need a great deal of help to carry out this task”, 2=“could carry out this task, but would need some help”, 3=“could carry out this task without any help”) asking about activities associated with doing the Developmental Assets model. The sum was then transformed to be on a 1–100% scale. A percentage point change is equivalent to a .02 change on the original 1–3 scale. A 50-percentage point change would be equivalent to a one-point change on the original 1–3 scale.|Baseline, mid (1 year), post (2 years)|Despite drop outs, all the data was used.||percentage of the highest possible score||Standard Deviation|Mean
779345|NCT00780338|Secondary|Prevention Capacity - Assets Behavior - (User v Non-User Analysis)|"This scale is the sum of 11 items with seven-point scales (1=“never” to 7=“very often”) assessing the frequency with which respondents engaged in assets activities during the previous 12 months. The sum was then transformed to be on a 1–100% scale. A percentage point change is equivalent to a .06 change on the original 1–7 scale. A 17-percentage point change would be equivalent to a one-point change on the original 1–7 scale. Same analysis/measure as the intent to treat, but instead just comparing users of AGTO to non-users within the AGTO assigned group. Use was determined by six items added to the Mid and Post Coalition Survey, called the AGTO Participation Index. If individuals received any hours of technical assistance, they received an additional point on the Index. Then, a dichotomous measure was created if a user participated (AGTO Participation Index >=1) at either Mid or Post."|Baseline, Mid (1 year), Post (2 years)|||percentage of the highest possible score||Standard Error|Least Squares Mean
779346|NCT00780338|Primary|Prevention Capacity - ASSETS Behaviors (Intent to Treat)|This scale is the sum of 11 items with seven-point scales (1=“never” to 7=“very often”) assessing the frequency with which respondents engaged in assets activities during the previous 12 months. The sum was then transformed to be on a 1–100% scale. A percentage point change is equivalent to a .06 change on the original 1–7 scale. A 17-percentage point change would be equivalent to a one-point change on the original 1–7 scale.|Baseline, Mid (1 year), Post (2 years)|Intent to Treat||percentage of the highest possible score||Standard Error|Least Squares Mean
779347|NCT00780338|Primary|Prevention Capacity - ASSETS GTO Behaviors (Intent to Treat)|This scale is the sum of 11 items with seven-point scales (1=“never” to 7=“very often”) assessing the frequency with which respondents engaged in AGTO activities during the previous 12 months. The sum was then transformed to be on a 1–100% scale. A percentage point change is equivalent to a .06 change on the original 1–7 scale. A 17-percentage point change would be equivalent to a one-point change on the original 1–7 scale.|Baseline, Mid (1 year), Post (2 years)|Intent to Treat||percentage of the highest possible score||Standard Error|Least Squares Mean
779348|NCT00780338|Secondary|Prevention Capacity - ASSETS GTO BEHAVIORS (User vs Non-user Analyses)|"This scale is the sum of 11 items with seven-point scales (1=“never” to 7=“very often”) assessing the frequency with which respondents engaged in AGTO activities during the previous 12 months. The sum was then transformed to be on a 1–100% scale. A percentage point change is equivalent to a .06 change on the original 1–7 scale. A 17-percentage point change would be equivalent to a one-point change on the original 1–7 scale. Same analysis/measure as the intent to treat, but instead just comparing users of AGTO to non-users within the AGTO assigned group. Use was determined by six items added to the Mid and Post Coalition Survey, called the AGTO Participation Index. If individuals received any hours of technical assistance, they received an additional point on the Index. Then, a dichotomous measure was created if a user participated (AGTO Participation Index >=1) at either Mid or Post."|Baseline, Mid (1 year), Post (2 years)|||percentage of the highest possible score||Standard Error|Least Squares Mean
779376|NCT00787761|Secondary|T-cell and Myeloid Chimerism at Days 90 Post-transplantation (>90% Chimerism)|Chimerism analysis of peripheral blood mononuclear cells using PCR for STR/VNTR will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism.|Day 90|20 of the patients treated on this study had Day 90 chimerism drawn.||participants|||Number
779552|NCT00792116|Primary|Math Grades||baseline (the beginning of a school semester )|106 participants were analyzed. One particiapant relocated to another school and one participant was removed by the teacher for discipline reasons.||average percentage correct||Standard Deviation|Mean
779349|NCT00780338|Secondary|Prevention Capacity - GTO Efficacy (User vs Non-user Analyses)|"The GTO efficacy scale is the sum of 10 items using a three-point scale (1=“would need a great deal of help to carry out this task”, 2=“could carry out this task, but would need some help”, 3=“could carry out this task without any help”) asking about activities associated with doing the AGTO 10 steps. The sum was then transformed to be on a 1–100% scale. A percentage point change is equivalent to a .02 change on the original 1–3 scale. A 50-percentage point change would be equivalent to a one-point change on the original 1–3 scale. Same analysis/measure as the intent to treat, but instead just comparing users of AGTO to non-users within the AGTO assigned group. Use was determined by six items added to the Mid and Post Coalition Survey, called the AGTO Participation Index. If individuals received any hours of technical assistance, they received an additional point on the Index."|Baseline, Mid (1 year), Post (2 years)|"Users had a AGTO Participation Index >=1 at either Mid or Post; Non Users had a AGTO Participation Index = 0"||percentage of the highest possible score||Standard Error|Least Squares Mean
779350|NCT00780338|Secondary|Prevention Capacity - GTO Behavior - (User v Non-User Analysis)|"This scale is the sum of 11 items with seven-point scales (1=“never” to 7=“very often”) assessing the frequency with which respondents engaged in GTO activities during the previous 12 months. The sum was then transformed to be on a 1–100% scale. A percentage point change is equivalent to a .06 change on the original 1–7 scale. A 17-percentage point change would be equivalent to a one-point change on the original 1–7 scale. Same analysis/measure as the intent to treat, but instead just comparing users of AGTO to non-users within the AGTO assigned group. Use was determined by six items added to the Mid and Post Coalition Survey, called the AGTO Participation Index. If individuals received any hours of technical assistance, they received an additional point on the Index. Then, a dichotomous measure was created if a user participated (AGTO Participation Index >=1) at either Mid or Post."|Baseline, Mid (1 year), Post (2 years)|||percentage of the highest possible score||Standard Error|Least Squares Mean
779351|NCT00780338|Primary|Prevention Capacity - GTO Behaviors (Intent to Treat)|This scale is the sum of 11 items with seven-point scales (1=“never” to 7=“very often”) assessing the frequency with which respondents engaged in AGTO activities during the previous 12 months. The sum was then transformed to be on a 1–100% scale. A percentage point change is equivalent to a .06 change on the original 1–7 scale. A 17-percentage point change would be equivalent to a one-point change on the original 1–7 scale.|Baseline, Mid (1 year), Post (2 years)|Intent to Treat||percentage of the highest possible score||Standard Error|Least Squares Mean
779352|NCT00780338|Secondary|Prevention Performance - Total Score (Descriptive Means)|A structured interview was used to assess the impact of AGTO on prevention practitioners' performance of tasks associated with high-quality prevention. Using the interview responses, a set of ratings were made assessing performance of activities in seven key domains: goals and objectives, best practices, planning, process evaluation, outcome evaluation, continuous quality improvement, and sustainability. The ratings are made on 10 items (or “components”) that assess how well each of the above mentioned activities are performed over the last year. Each component has seven response choices, described with specific, observable behaviors, that range from “highly faithful=7” to “highly divergent=1” from ideal performance. The total score is an average of the 10 components, and has the same range as the individual components (“highly faithful=7” to “highly divergent=1” from ideal performance)|baseline, baseline to mid (1 year), mid to posttest (2 years)|Whole programs are rated, not individuals, because programs operate as a unit. These means are presented at the timepoints in which they were collected.||units on a scale|Participants|Full Range|Mean
779353|NCT00780338|Primary|Prevention Capacity-GTO Efficacy (Intent to Treat)|Assessed in the Coalition Survey, prevention capacity was defined as efficacy and behaviors of practitioners. GTO efficacy scale is the sum of 10 items using a three-point scale (1=“would need a great deal of help to carry out this task”, 2=“could carry out this task, but would need some help”, 3=“could carry out this task without any help”) asking about activities associated with doing the AGTO 10 steps. The sum was then transformed to be on a 1–100% scale. A percentage point change is equivalent to a .02 change on the original 1–3 scale. A 50-percentage point change would be equivalent to a one-point change on the original 1–3 scale.|Baseline, mid-point (1 year), posttest (2 years)|Despite drop outs, all the data was used.||percentage of the highest possible score||Standard Deviation|Mean
779354|NCT00780403|Primary|Number of Subjects Who Preferred Desloratadine RediTab or Zyrtec Chewable Tablet.|"A product preference questionnaire was completed after the administration of the second study drug. An interviewer instructed the subject now that you have tasted the two tablets, show us which tablet you like more and the subject then marked which tablet he/she preferred. If the subject had no preference, the response was recorded accordingly."|Following the second dose (8-10 minutes after the first dose)|All randomized subjects received either Reditab or Zyrtec, followed 8-10 minutes later by the opposite study drug (Reditab followed by Zyrtec or Zyrtec followed by Reditab).||participants|||Number
779355|NCT00780416|Primary|The Percentage of Subjects Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)||After 24 weeks of follow-up|||percentage of subjects achieving SVR||95% Confidence Interval|Number
779356|NCT00780455|Secondary|Quality of Life Assessed by Use of Self-questionnaire (SEP-59)|SEP (Sclérose en plaques) - 59: auto-questionnaire, multidimensional investigating the felt health. It contains a generic part SF (Short Form) 36 constituted by 36 items including the main concepts of quality of life and a specific part to the MS which investigates the dimensions susceptible to be degraded. 59 items are grouped in 16 dimensions: physical activity, limitations bound connected to the physical health, to the mental health, the social well-being, the pain, the energy, the emotional well-being, general Health, distress, cognitive function sexual function/satisfaction, well-being general, sleep and social support. Visit to a neurologist: V0=baseline; V1=end of Month 1 of treatment; V2=end of Month 2 of treatment; V3=end of Month 3 of treatment. Visit to MR (Medecin Reeducateur: physician for rehabilitation): MR1=1st visit within 15 days after V0; MR2=2nd visit (6 weeks after MR1 +/- 1 week); MR3=end of study visit 12 weeks after MR1.|From baseline to 12 weeks after MR1 visit|Due to the very low number of patients enrolled in the study, no statistical report was done.|||||
779689|NCT00793572|Primary|Progression-free Survival|"Confidence intervals will be estimated.
Progressive disease:
Greater than 25% increase in serum (absolute increase must be ≥0.5 g/dL) or urine (absolute increase must be ≥200 mg/24h) M proteins compared to best response status after autologous transplant.
Appearance of new lytic bone lesions or plasmacytomas."|At 2 years after the autograft|||Participants|||Count of Participants
779358|NCT00780455|Secondary|Posturography Gain in Static Equilibrium Performances Between MR2 and MR3 Visits|"Posturography protocol: Static equilibrium performances are evaluated in the standing patient on a fixed platform, in the standardized position (arms dangling, feet open at 30° and malleolus at a 5 cm distance). Participants had the following two types of visit during the study, one visit with a neurologist and one visit with a rehabilitation physician. Visit to a neurologist: V0=baseline; V1=end of Month 1 of treatment; V2=end of Month 2 of treatment; V3=end of Month 3 of treatment. Visit to MR (Medecin Reeducateur: physician for rehabilitation): MR1=1st visit within 15 days after V0; MR2=2nd visit (6 weeks after MR1 +/- 1 week); MR3=end of study visit 12 weeks after MR1. This outcome was only measured on patients in the group Interferon beta-1b, FRP within 15 days after randomization."|At MR2 visit (6 weeks after MR1 visit) and MR3 visit (12 weeks after MR1 visit)|Due to the very low number of patients enrolled in the study, no statistical report was done.|||||
779359|NCT00780455|Secondary|Posturography Gain in Static Equilibrium Performances Between Baseline and 12 Weeks After MR1 Visit|Posturography protocol: Static equilibrium performances are evaluated in the standing patient on a fixed platform, in the standardized position (arms dangling, feet open at 30° and malleolus at a 5 cm distance). Participants had the following two types of visit during the study, one visit with a neurologist and one visit with a rehabilitation physician. Visit to a neurologist: V0=baseline; V1=end of Month 1 of treatment; V2=end of Month 2 of treatment; V3=end of Month 3 of treatment. Visit to MR (Medecin Reeducateur: physician for rehabilitation): MR1=1st visit within 15 days after V0; MR2=2nd visit (6 weeks after MR1 +/- 1 week); MR3=end of study visit 12 weeks after MR1.|At baseline and 12 weeks after MR1 visit|Due to the very low number of patients enrolled in the study, no statistical report was done.|||||
779360|NCT00780455|Secondary|Knee Isokinetic Gain Between Baseline and 12 Weeks After MR1 Visit|The isokinetic evaluation analyses the flexor/extensor ratio at different rates. The evaluation will be done at the beginning on the best clinical side otherwise on the strongest. Participants had the following two types of visit during the study, one visit with a neurologist and one visit with a rehabilitation physician. Visit to a neurologist: V0=baseline; V1=end of Month 1 of treatment; V2=end of Month 2 of treatment; V3=end of Month 3 of treatment. Visit to MR (Medecin Reeducateur: physician for rehabilitation): MR1=1st visit within 15 days after V0; MR2=2nd visit (6 weeks after MR1 +/- 1 week); MR3=end of study visit 12 weeks after MR1.|At baseline and 12 weeks after MR1 visit|Due to the very low number of patients enrolled in the study, no statistical report was done.|||||
779361|NCT00780455|Secondary|Covered Distance Gain Between MR2 Visit and MR3 Visit|"Participants had the following two types of visit during the study, one visit with a neurologist and one visit with a rehabilitation physician. Visit to a neurologist: V0=baseline; V1=end of Month 1 of treatment; V2=end of Month 2 of treatment; V3=end of Month 3 of treatment. Visit to MR (Medecin Reeducateur: physician for rehabilitation): MR1=1st visit within 15 days after V0; MR2=2nd visit (6 weeks after MR1 +/- 1 week); MR3=end of study visit 12 weeks after MR1. This outcome was only measured on patients in the group Interferon beta-1b, FRP within 15 days after randomization."|At MR2 visit (6 weeks after MR1 visit) and MR3 visit (12 weeks after MR1 visit)|Due to the very low number of patients enrolled in the study, no statistical report was done.|||||
779362|NCT00780455|Primary|Rhythm Change During 6 Minutes Walking Test||Up to 6 minutes|Due to the very low number of patients enrolled in the study, no statistical report was done.|||||
779363|NCT00780455|Primary|Distance of Discomfort Appearance||Up to 6 minutes|Due to the very low number of patients enrolled in the study, no statistical report was done.|||||
779364|NCT00780455|Primary|Time of Discomfort Appearance||Up to 6 minutes|Due to the very low number of patients enrolled in the study, no statistical report was done.|||||
779365|NCT00780455|Primary|Total Walking Area (in Covered Meters) Either After 6 Minute or at the Time of the Premature Stop of the Test.||Up to 6 minutes|Due to the very low number of patients enrolled in the study, no statistical report was done.|||||
779366|NCT00780481|Secondary|Lipid Levels, PAI-1 Levels, CRP Levels, F2 Isoprostanes and Other Biomarkers of Inflammation and Obesity.||Single Study Day|Data was lost|||||
779367|NCT00780481|Secondary|Radial Artery Elasticity||Single Study Visit|Data was lost|||||
779368|NCT00780481|Secondary|Peak FMD||Single Study Day|Data Lost|||||
779369|NCT00780481|Primary|Peak t-PA Release|tPA Release|Single Study day|Data was lost|||||
779370|NCT00787761|Secondary|Overall Survival (OS) at 24 Months|Overall survival refers to the length of time a patient is alive after transplant regardless of whether they have progressive or relapsed disease.|24 months|23 patients were able to be analyzed for OS at 24 months||participants|||Number
779371|NCT00787761|Secondary|Disease-free Survival (DFS) at 24 Months|Disease Free survival is measured by the amount of time a patient spends in a disease free state after being transplanted.|24 months|23 patients were able to be analyzed for DFS at 24 months||participants|||Number
779372|NCT00787761|Secondary|Non-relapse Mortality (NRM) at Day 180 Post-transplantation|non-relapse mortality refers to the death of a patient for causes other than relapsed disease.|Day 180|23 patients were able to be analyzed for NRM at 180 days||participants|||Number
779373|NCT00787761|Secondary|Number of Patients Experiencing Extensive Chronic Graft Versus Host Disease (GVHD)|Patients who had post-transplant complication (GVHD) as seen by clinical evidence including but not limited to skin rash, elevated liver function tests, nausea/vomiting/diarrhea.|2 years|23 patients were able to be analyzed for severe gvhd||participants|||Number
779374|NCT00787761|Secondary|Number of Patients Who Experience Severe (Grade 3 or 4) Acute Graft-versus-host Disease|number of patients who experienced post-transplant complication (GVHD) as seen by clinical evidence including but not limited to skin rash, elevated liver function tests, nausea/vomiting/diarrhea.|Day 100|23 patients were able to be analyzed for severe gvhd||participants|||Number
779375|NCT00787761|Secondary|T-cell and Myeloid Chimerism at Days 180 Post-transplantation (>90%)|Chimerism analysis of peripheral blood mononuclear cells using PCR for STR/VNTR will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism.|180 days|20 of the patients treated on study had chimerism drawn on day 180.||participants|||Number
779690|NCT00793585|Secondary|The Longitudinal Change in Proteinuria and Blood Pressure(Including Changes in Antihypertensive Drugs Dosing).||baseline and 6 months|We analysed all patient's data according to the ITT rule.And used the LOCF as the imputation technique.||Upro/cr (mg/g)||Standard Deviation|Mean
779379|NCT00787787|Secondary|Best Response by RECIST Criteria|Incidence rate of best clinical response (complete response [CR], partial response [PR], stable disease [SD], or progressive disease[PD]) as assessed by the Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR indicates disappearance of all target lesions. PR indicates at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease indicates at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) indicates neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|From the start of the treatment until disease progression/recurrence, assessed every 3 months, up to 3 years|Only 4 patients in this study had assessments of response by RECIST criteria.||Participants|||Count of Participants
779380|NCT00787787|Primary|Median Progression-free Survival|Analyzed using the Kaplan-Meier method. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Progressive disease (PD) indicates at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|From the start of treatment to time of progression or death from any cause, assessed up to 3 years|||days||Full Range|Median
779381|NCT00787800|Secondary|Atrial Fibrillation (AF) Burden|AF burden is defined as the sum of duration of all atrial arrhythmias divided by total observation time, reported as a percentage value.|Implantation through 1 year|Intent to treat analysis population.||Percentage of atrial arrhythmias per min||Standard Deviation|Mean
779382|NCT00787800|Secondary|Number of Subjects With Newly Detected Atrial Tachyarrhythmias||Baseline to 12 months after ICD implantation|Intent to Treat population analyzed.||Participants|||Number
779383|NCT00787800|Secondary|Total Cost of ICD Implantation Procedure||Baseline|Only the 45 subjects enrolled at Mayo Clinic in Rochester, Minnesota were analyzed for ICD implantation costs.||US Dollars||Standard Deviation|Mean
779384|NCT00787800|Secondary|Number of Appropriate Shocks by ICD|Appropriate shocks are delivered during a sustained Ventricular Tachycardic/Ventricular Fibrillation heart rhythm.|Baseline to 12 Months|Intent to Treat population analyzed.||Shocks|||Number
779385|NCT00787800|Secondary|Number of Atrial Tachyarrhythmia Episodes Lasting Over 5 Minutes|Episodes of Atrial Fibrillation (AF) or Atrial Flutter (AFL) greater than 5 minutes duration. A subject may experience multiple episodes.|Baseline to 12 Months|Intent to Treat population analyzed. 37 episodes in 5 subjects (all in dual chamber arm).||Episodes|||Number
779386|NCT00787800|Primary|Number of Subjects Inappropriately Shocked by Implantable Cardioverter-Defibrillator (ICD)|An inappropriate shock is defined as a shock delivered by the ICD during a rhythm other than sustained VT/VF (ventricular tachycardia/ventricular fibrillation).|Baseline to 12 months after ICD implantation|Intent to Treat population analyzed.||Participants|||Number
779387|NCT00787839|Secondary|Cost to Identify a Single Case of High-risk Dysglycemia or Previously Unrecognized Diabetes|Cost was expressed as cost (dollars) to identify a single case, with cases defined as (i) diabetes or (ii) high-risk dysglycemia. Cost projections for screening were conducted from both Medicare and VA perspectives. All screening projections assumed follow-up testing with an OGTT if the screening test exceeded a 70% specificity cut-off.|3 years|||Dollars|||Number
779388|NCT00787839|Primary|Ability of Different Screening Tests Which Can be Performed Opportunistically (During Outpatient Visits -- at Any Time of Day, Regardless of Meal Status) to Predict Findings With the Oral Glucose Tolerance Test (in the Morning, After an Overnight Fast)|"Area under ROC curve (AROC) for prediction of diabetes (based on OGTT) and high-risk dysglycemia (based on OGTT, IGT with 2 hour OGTT glucose 140-199 mg/dl, and/or IFG with fasting glucose 110-125 mg/dl).
ROC curves are plots of (1-sensitivity) vs. (1-specificity) for all possible screening cutoffs, so a higher AROC indicates higher predictive accuracy. A perfect test would have an AROC of 1.00, while a test equivalent to tossing a coin (random) would have an AROC of 0.50; if confidence limits include 0.50, predictive accuracy is no better than chance.
It is important to appreciate that while AROC analysis can show the relative accuracy of different screening tests, and aid the selection of which test to use in clinical practice, such an analysis does not define what the optimal screening test cutoff is. Selection of the optimal cutoff generally requires consideration of other factors, such as costs and/or the clinical importance of having higher or lower sensitivity."|3 years|||area under ROC curve||95% Confidence Interval|Number
779389|NCT00787852|Secondary|Complete and Partial Response by CT Scan or MRI||within 30 days of last treatment||||||
779390|NCT00787852|Primary|Number of Patients Who Came Off Study for Toxicity Using CTC Version 3.0|6 patients came off study for toxicity|within 28 days after the last radiation treatment|||participants|||Number
779391|NCT00787891|Secondary|The Change From Baseline in the Total GERD Symptom and Severity Score (Double-blind Maintenance Treatment Phase)|The gastroesophageal reflux disease (GERD) symptom and severity scale measures the frequency (0= Never; 1= 1-2 times; 2= 3-4 times; 3= 5-6 times; 4= 7 or more times) and the severity (1= Mild; 2= Moderate; 3=Severe) of GERD symptoms. The score is defined as the sum of the frequency (0-4) and severity (1-3) of that symptom. The total score is the sum of the scores of all the symptoms and ranges from 12 to 84. Higher scores indicate more serious condition. For change from baseline, 0 indicates no change; a positive score indicates worsening, while a negative score indicates improvement.|Baseline, Week 36|Intention to Treat (ITT) analysis set||Scores on a scale||Standard Deviation|Mean
779392|NCT00787891|Secondary|The Change From Baseline in the Hetzel and Dent Endoscopic Classification Grade Score (Double-blind Maintenance Treatment Phase)|The Hetzel and Dent Classification grades range from 0 (normal esophageal mucosa, no abnormalities noted) to 4 (deep ulcers anywhere in the esophagus or ulceration of more than half of the esophageal mucosa). Higher observed scores indicate more serious condition. For change of baseline, a score of 0 indicates no change; a positive score indicates the condition is worsening, while a negative score indicates an improvement.|Baseline, Week 36|Intention to Treat (ITT) analysis set||Scores on a scale||Standard Deviation|Mean
779511|NCT00791778|Other Pre-specified|EQ-5D Visual Analogue Scale (VAS) Score at Cycle 1/Baseline|The EQ-5D also contains a VAS, which records the respondent’s self-rated health status on a vertical graduated scale. The scale ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).|At Cycle 1 (4 weeks per Cycle)/baseline|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at least one post-baseline assessment||Scores on a scale||Standard Deviation|Mean
779393|NCT00787891|Secondary|The Change From Baseline in the Total GERD Symptom and Severity Score (Short-term Double-blind Treatment Phase)|The gastroesophageal reflux disease (GERD) symptom and severity scale measures the frequency (0= Never; 1= 1-2 times; 2= 3-4 times; 3= 5-6 times; 4= 7 or more times) and the severity (1= Mild; 2= Moderate; 3=Severe) of GERD symptoms. The score is defined as the sum of the frequency (0-4) and severity (1-3) of that symptom. The total score is the sum of the scores of all the symptoms and ranges from 12 to 84. Higher scores indicate more serious condition. For change from baseline, 0 indicates no change; a positive score indicates worsening, while a negative score indicates improvement.|Baseline, Week 12|Intention to Treat (ITT) analysis set||Scores on a scale||Standard Deviation|Mean
779394|NCT00787891|Secondary|The Change From Baseline in the Hetzel and Dent Endoscopic Classification Grade Score (Short-term Double-blind Treatment Phase)|The Hetzel and Dent Classification grades range from 0 (normal esophageal mucosa, no abnormalities noted) to 4 (deep ulcers anywhere in the esophagus or ulceration of more than half of the esophageal mucosa). Higher observed scores indicate more serious condition. For change of baseline, a score of 0 indicates no change; a positive score indicates the condition is worsening, while a negative score indicates an improvement.|Baseline, Week 12|Intention to Treat (ITT) analysis set||Scores on a scale||Standard Deviation|Mean
779395|NCT00787891|Primary|The Percentage of Patients With Healing by Week 36 (Double-blind Maintenance Treatment Phase)|Healing is defined as macroscopically normal esophageal mucosa or histologic normal esophageal mucosa.|36 weeks|Intention to Treat (ITT) analysis set||Percentage of patients||95% Confidence Interval|Number
779396|NCT00787891|Primary|The Percentage of Patients With Healing by Week 12 (Short-term Double-blind Treatment Phase)|Healing is defined as macroscopically normal esophageal mucosa or histologic normal esophageal mucosa.|12 weeks|Intention to Treat (ITT) analysis set||Percentage of participants||95% Confidence Interval|Number
779397|NCT00787904|Secondary|Bone Mineral Density|Please note that the bone density measurements were done AFTER THE PRIMARY endpoints because bone mineral density changes take longer to see differences|2 years||||||
779398|NCT00787904|Primary|Percent Change in Thymus Size Measured by CT Scan||2 years|||percent change||Standard Deviation|Mean
779399|NCT00787904|Primary|Changes in T-cell Activation Measured by Flow Cytometry, Specifically the Percentage of CD3+CD69+ T-cells|(Please note to reviewer, CD3 positivity indicates a T-cell, the title is correct)|2 years|||percentage of CD3 positive cells||Standard Deviation|Mean
779400|NCT00787917|Secondary|Percentage of Participants Responding to Omalizumab, as Defined by a Reduction in Oral Corticosteroid Dose Use of 50% or More as Compared to Baseline||6 months, 12 months|No statistical analysis was performed due to insufficient study enrollment||percentage of participants||Standard Error|Least Squares Mean
779401|NCT00787917|Secondary|Change From Baseline in Average Oral Corticosteroid Use.||6 months, 12 months|No statistical analysis was performed due to insufficient study enrollment||mg/day||Standard Deviation|Mean
779402|NCT00787917|Secondary|Time to Steroid Free State.||12 months|No statistical analysis was performed due to insufficient study enrollment||days||Standard Deviation|Mean
779403|NCT00787917|Secondary|Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline, Measured at 3 and 6 Months of Treatment||3 months, 6 months|No statistical analysis was performed due to insufficient study enrollment||Liters||Standard Error|Least Squares Mean
779404|NCT00787917|Secondary|Change in Allergic Bronchopulmonary Aspergillosis (ABPA) Exacerbation Rates During Double-blind Treatment Period and Open-label Treatment Period||6 months, 12 months|No statistical analysis was performed due to insufficient study enrollment||percentage||Standard Error|Least Squares Mean
779405|NCT00787917|Primary|Change From Baseline, as Measured by the Percentage of Participants Requiring Rescue With Corticosteroids, and as Measured by the Time to Deviation From the Protocol Prescribed Steroid Tapering Regimen||6 months of blinded treatment|No statistical analysis was performed due to insufficient study enrollment||percentage||Standard Error|Least Squares Mean
779406|NCT00787930|Secondary|fa ROFC in Subjects Who Received Continuation Treatment|As an exploratory analysis, subject MRI's were also evaluated using diffusion tensor imaging (DTI) for differences in fractional anisoptery (fa) in the Right Orbitofrontal area (ROFC). FA is a scalar value between zero and one hundred that describes the degree of anisotropy of a diffusion process. A value of zero means that the diffusion is isotropic (unrestricted in all directions). A value of one hundred means that diffusion occurs only along one axis and is fully restricted along all other directions.|up to 12 months|Number of subjects in continuation phase who had MRIs that were able to be processed for DTI data.||units on a scale||Standard Deviation|Mean
779407|NCT00787930|Secondary|fa LOFC in Subjects Who Received Continuation Treatment|As an exploratory analysis, subject MRI's were also evaluated using diffusion tensor imaging (DTI) for differences in fractional anisoptery (fa) in the Left Orbitofrontal area (LOFC). FA is a scalar value between zero and one hundred that describes the degree of anisotropy of a diffusion process. A value of zero means that the diffusion is isotropic (unrestricted in all directions). A value of one hundred means that diffusion occurs only along one axis and is fully restricted along all other directions.|up to 12 months|Number of subjects in continuation phase who had MRIs that were able to be processed for DTI data.||units on a scale||Standard Deviation|Mean
779408|NCT00787930|Secondary|Boyko Subcortical (SC) Hyperintensity Value >2 in Subjects Who Received Continuation Treatment|Subject were evaluated for relapse of their mood disorder and for the presence of subcortical (SC) Hyperintensities (>2 on the the Boyko Classification). Boyko lesion classification system assesses SC hyperintensities as follows: 0 = absent, 1 = punctate, 2 = rounded <5 mm, 3 = irregular >5 mm, 4 = confluent lesions. Subjects were also assessed for relapse, as defined by the Montgomery-Asberg Depression Rating Scale (MADRS)and the Young Mania Rating Scale (YMRS).|up to 12 months|Number of subjects who who had >2 on the DWM hyperintensity assessment from the Boyko classification system.||participants|||Number
779438|NCT00791492|Secondary|Percentage of Participants With Stabilized Transthyretin (TTR) Tetramer|TTR tetramer was assessed using a validated immunoturbidimetric assay. The Fraction of Initial (FOI) is the ratio of the measured TTR tetramer concentration after denaturation to the measured TTR tetramer concentration before denaturation. TTR tetramer stabilization is based on the difference between the on-treatment FOI and the baseline FOI expressed as a percentage of the baseline FOI.|Month 6, 12|ITT population included all participants who received at least one dose of study medication and had no more than 2 months interruption between studies FX-005 and FX-006. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||percentage of participants||95% Confidence Interval|Number
779409|NCT00787930|Primary|Boyko DWM Hyperintensity Value >2 in Subjects Who Received Continuation Treatment|Subject were evaluated for relapse of their mood disorder and for the presence of DWM Hyperintensities (>2 on the the Boyko Classification. Boyko lesion classification system assesses DWM hyperintensities as follows: 0 = absent, 1 = punctate, 2 = rounded <5 mm, 3 = irregular >5 mm, 4 = confluent lesions. Subjects were also assessed for relapse, as defined by the Montgomery-Asberg Depression Rating Scale (MADRS)and the Young Mania Rating Scale (YMRS). Relapse was defined by protocol as either a MADRS scale >15 or a YMRS scale >15.|12 months|Subjects who completed at least 4-12 months of consistent follow up appointments after stabilization from an acute manic episode. Note that 3 subjects dropped out of continuation treatment.||participants|||Number
779410|NCT00787930|Primary|Boyko DWM Hyperintensity Value >2 in Subjects Who Received Acute Treatment for Mania|Subject with acute mania were treated for 3 weeks with STEP-BD protocol using valproic acid as the primary intervention. Subject MRI's were evaluated for the presence of deep white matter hyperintensities (DWM) (>2 on the the Boyko Classification). Boyko lesion classification system assesses DWM hyperintensities as follows: 0 = absent, 1 = punctate, 2 = rounded <5 mm, 3 = irregular >5 mm, 4 = confluent lesions.|3 weeks|All subjects in an acute manic state who were treated with specified protocol.||participants|||Number
779411|NCT00787943|Primary|Number of Inflammatory Lesions (Papules and Pustules)|Assessment will be done based on lesion counting. We will compare the lesions treated twice daily with the benzoyl peroxide 10.0% cream Formulation #1 vs. the benzoyl peroxide 10.0% cream Formulation #2.|4 Weeks|Papules and pustules were analyzed on the left and right side of the face for each of the 10 subjects. Analysis was per protocol with intention to treat.||Lesions|||Number
779412|NCT00788008|Primary|Change in Neurocognitive Performance (Z-score)|"Mean change on composite scores (z-score) for memory and executive function measures.
Memory measures: Hopkins Verbal Learning Test–Revised and the Brief Visuospatial Memory Test–Revised.
Executive function measures: the Trail Making Test (Army, 1944), Digit-symbol substitution and Symbol Search subtests of the Processing Speed Index of the Wechsler Adult Intelligence Scale-III (WAIS-III; Wechsler, 1997) and the Controlled Oral Word Association subtest of the Multilingual Aphasia Examination.
The outcomes were constructed as summed z-score composites. They are scaled as standard deviations. Thus, a score of 0 was central on each composite, and 95% of the scores would fall within -2.0 and +2.0. While there is no minimum or maximum value is rare for any score (<1%) to fall outside the -3.0 to +3.0 range.
Higher scores (and thus positive change value) indicate an improvement of function."|3 months post operatively|||z score||Full Range|Mean
779413|NCT00788073|Post-Hoc|ABC-FXS Social Avoidance Subscore|After completion of the study, but during data analysis, the ABC-C assessment was independently re-validated in Fragile X Syndrome subjects. The subscales were re-factored into a Fragile-X Syndrome specific ABC-C (ABC-FX). The ABC-FX contains the same 58 questions as the original ABC-C but there are six subscales. One of the subscales is Social Avoidance, which consists of 4 items. Minimum score is 0, maximum is 12. A decreased score indicates fewer social avoidant behaviors. A post-hoc analysis was performed from the study data examining the social avoidance subscale of the ABC-FX.|4 week treatment period|||Points on a scale||Standard Error|Least Squares Mean
779414|NCT00788073|Primary|Aberrant Behavior Checklist Irritability Subscore|The Aberrant Behavior Checklist-Community Edition (ABC-C) is a 58-item questionnaire composed of five different independent subscales. The questionnaire is completed by the parent/caregiver and lists aberrant behaviors and asks about the severity of the problem. ABC-Irritability is one of the subscales and comprises of 15 items. Minimum score is 0, maximum is 45. A decreased score indicates few aberrant behaviors and clinical improvement. The entire ABC-C assessment is administered at baseline and then at the end of each Intervention Period (4 weeks after Baseline).|After 4 weeks of treatment|||Points on a scale||Standard Error|Least Squares Mean
779415|NCT00791479|Secondary|Collection and Evaluation of Plasma Levels (Pharmacokinetics [PK]) of LY2189265|The population mean estimates and standard deviations were calculated for pharmacokinetic parameters (area under the concentration time curve (AUC) from zero to 168 hours). Evaluable PK concentrations from the 4 week, 8 week, and 12 week timepoints were combined and utilized in a population approach to determine the population mean estimate and standard deviation at steady-state.|4 weeks, 8 weeks, 12 weeks|Participants who received at least one dose of LY2189265 (0.1-3.0 milligrams [mg]) with evaluable pharmacokinetic data.||nanograms*hour/milliliter (ng*h/mL)||Standard Deviation|Mean
779416|NCT00791479|Secondary|Antibody Production and Effects to LY2189265|LY2189265 anti-drug antibodies (ADA) were assessed at baseline, 4 and 12 weeks, and at the safety follow-up visit 4 weeks after study drug discontinuation (16 weeks). The number of participants with initial postbaseline detection of treatment emergent (defined as a 4-fold increase in the ADA titer from baseline) LY2189265 ADA at each time point were summarized.|Baseline, 4 weeks, 12 weeks, 16 weeks|Participants who received at least one dose of study drug with evaluable LY2189265 anti-drug antibodies (ADA) data.||participants|||Number
779417|NCT00791479|Secondary|Change From Baseline in Body Weight|Least Squares (LS) means was calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline measurement as covariate.|Baseline, 12 weeks|Participants who received at least one dose of study drug and have body weight change from baseline data available.||kilogram (kg)||Standard Error|Least Squares Mean
779418|NCT00791479|Secondary|Treatment Emergent Adverse Events|A treatment emergent adverse event is any untoward medical occurrence that either occurs or worsens at any time after the first injection of study drug following randomization and which does not necessarily have to have a causal relationship. The number of participants with one or more treatment emergent adverse event was reported. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 12 weeks|Participants who received at least one dose of study drug.||participants|||Number
779437|NCT00791492|Other Pre-specified|Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)|An Adverse Event (AE) was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. SAE: AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent/significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug, up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to 30 days after last dose of study medication|Safety population included participants who received at least one dose of study medication.||participants|||Number
779419|NCT00791479|Secondary|Rate of Self-reported Hypoglycemic Events|Hypoglycemic events (HE) were classified as severe (defined as events requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined an event during which typical symptoms of hypoglycemia were accompanied by a blood glucose level of ≤3.9 millimoles per liter [mmol/L]), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured blood glucose of ≤3.9 mmol/L), or nocturnal (defined as any HE that occurred between bedtime and breakfast with a measured blood glucose of ≤3.9 mmol/L). Participant reports of HE were collected at the beginning of each visit starting at Baseline and the annualized rate was reported. Least Squares (LS) means rates were adjusted for pre-study therapy, country, and baseline body mass index. A summary of AEs regardless of causality is located in the Reported AEs module. Some model-adjusted LS means are less than 0 and may be interpreted as very low rates.|Baseline through 12 weeks|Participants who received at least one dose of study drug and have self-reported hypoglycemic event data available. Only pre-rescue measurements were used.||Events per participant per year||Standard Error|Least Squares Mean
779420|NCT00791479|Secondary|Number of Participants With Self-reported Hypoglycemic Events|Hypoglycemic events were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined an event during which typical symptoms of hypoglycemia were accompanied by a blood glucose level of ≤3.9 millimoles per liter [mmol/L]), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured blood glucose of ≤3.9 mmol/L), or nocturnal (defined as any hypoglycemic event that occurred between bedtime and breakfast with a measured blood glucose of ≤3.9 mmol/L). Participant reports of hypoglycemic events were collected at the beginning of each visit starting at Baseline. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 12 weeks|Participants who received at least one dose of study drug and have self-reported hypoglycemic event data available. Only pre-rescue measurements were used.||participants|||Number
779421|NCT00791479|Secondary|Change From Baseline in Blood Pressure (BP)|Sitting systolic blood pressure (SBP) and sitting diastolic blood pressure (DBP) were measured. Least Squares (LS) means of change were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline measurement as covariate.|Baseline, 12 weeks|Participants who received at least one dose of study drug and have blood pressure change from baseline data available.||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
779422|NCT00791479|Secondary|Change From Baseline in Pulse Rate|Sitting pulse rate was measured. Least Squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline measurement as covariate.|Baseline, 12 weeks|Participants who received at least one dose of study drug and have pulse rate change from baseline data available.||beats per minute (bpm)||Standard Error|Least Squares Mean
779423|NCT00791479|Secondary|Change From Baseline in Electrocardiograms (ECGs) - Heart Rate|Least Squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline measurement as covariate.|Baseline, 12 weeks|Participants who received at least one dose of study drug and have heart rate change from baseline data available.||beats per minute (bpm)||Standard Error|Least Squares Mean
779424|NCT00791479|Secondary|Change From Baseline in Electrocardiograms (ECGs) - Fridericia-corrected QT (QTcF) and PR Interval|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. The PR segment begins at the endpoint of the P wave and ends at the onset of the QRS complex. Least Squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline measurement as covariate.|Baseline, 12 weeks|Participants who received at least one dose of study drug and have Fridericia-corrected QT (QTcF) or PR interval change from baseline data available.||millisecond (msec)||Standard Error|Least Squares Mean
779425|NCT00791479|Secondary|Change From Baseline in Insulin Sensitivity (HOMA2-%S)|Change from baseline in insulin sensitivity (HOMA2-%S) was assessed by using the homeostatic model assessment (HOMA) to quantify insulin sensitivity. HOMA2-%S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state insulin sensitivity (%S), as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. Least Squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline HOMA2-%S as covariate.|Baseline, 12 weeks|Participants who received at least one dose of study drug and have insulin sensitivity change from baseline data available. Only pre-rescue measurements were used.||percentage of HOMA2-%S||Standard Error|Least Squares Mean
779426|NCT00791479|Secondary|Change From Baseline in Beta-cell Function (HOMA2-%B)|Change from baseline in beta (β)-cell function (HOMA2-%B) was assessed by using the homeostatic model assessment (HOMA) to quantify β-cell function. HOMA2-%B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state beta cell function (%B), as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. Least Squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline HOMA2-%B as covariate.|Baseline, 12 weeks|Participants who received at least one dose of study drug and have beta-cell function (HOMA2-%B) change from baseline data available. Only pre-rescue measurements were used.||percentage of HOMA2-%B||Standard Error|Least Squares Mean
779439|NCT00791492|Secondary|Intraepidermal Nerve Fiber (IENF) Density|IENF density was quantified in 3 millimeter (mm) immunostained skin punch biopsies containing epidermis and superficial dermis to evaluate the amount and morphological appearance of small diameter nerve fibers, both somatic and autonomic, in sensory neuropathies. It is used in diagnosing various neuropathic conditions.|Baseline|ITT population included all participants who received at least one dose of study medication and had no more than 2 months interruption between studies FX-005 and FX-006. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||fibers/mm||Standard Deviation|Mean
779427|NCT00791479|Secondary|Change From Baseline in Daily Mean Blood Glucose Values From the 7-point Self Monitored Blood Glucose (SMBG) Profiles|Change from baseline in mean daily blood glucose values were measured with a 7-point self-monitored blood glucose (SMBG) profile over a 24-hour period in the 7-day period prior to each visit. The 7-point SMBG profile consisted of preprandial blood glucose measures before the morning, midday, and evening meals; blood glucose measures 2 hours after the start of the morning, midday, and evening meals; and the fasting blood glucose obtained the following morning. Mean at 12 weeks was assessed in all treatment groups. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and as covariate.|Baseline, 12 weeks|Participants who received at least one dose of study drug and have blood glucose change from baseline data available. Only pre-rescue measurements were used.||milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
779428|NCT00791479|Secondary|Percentage of Participants Who Achieve Glycosylated Hemoglobin (HbA1c) <7% or ≤6.5%|Percentages of participants who achieved glycosylated hemoglobin (HbA1c) levels of <7.0% or ≤6.5% were compared across treatment arms using the Cochran-Armitage trend test.|12 weeks|Participants who received at least one dose of study drug and have HbA1c data available. Only pre-rescue measurements were used.||percentage of participants|||Number
779429|NCT00791479|Secondary|Change From Baseline in Fasting Blood Glucose|Fasting blood glucose is a test to determine how much glucose (sugar) is in a blood sample after an overnight fast. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline fasting glucose as covariate.|Baseline, 12 weeks|Participants who received at least one dose of study drug and have fasting blood glucose change from baseline data available. Only pre-rescue measurements were used.||milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
779430|NCT00791479|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline glycosylated hemoglobin (HbA1c) as covariate.|Baseline, 4 weeks, 8 weeks|Participants who received at least one dose of study drug and have glycosylated hemoglobin (HbA1c) change from baseline data available. Only pre-rescue measurements were used.||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
779431|NCT00791479|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|Least Squares (LS) means of change from baseline for glycosylated hemoglobin (HbA1c) were calculated using mixed model repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline HbA1c as covariate.|Baseline, 12 weeks|Participants who received at least one dose of study drug and have glycosylated hemoglobin (HbA1c) change from baseline data available. Only pre-rescue measurements were used.||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
779432|NCT00791492|Other Pre-specified|Number of Participants Who Discontinued Due to Clinical or Laboratory Adverse Events|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to Month 12|Safety population included participants who received at least one dose of study medication.||participants|||Number
779433|NCT00791492|Other Pre-specified|Number of Participants With Clinically Significant Treatment-emergent Holter Monitor Findings|Clinically significant Holter monitor findings included: atrial fibrillation/flutter, atrial tachycardia, non-sustained ventricular tachycardia (<30 beats), sustained ventricular tachycardia (>= 30 beats), sinus pause (RR >2.0 second, where RR=60/heart rate), ventricular premature contractions.|Baseline, Day 1 up to Month 12 (anytime on-treatment)|Safety population included participants who received at least one dose of study medication. ‘n’ signifies participants for this measure at specified time point for each arm group.||participants|||Number
779434|NCT00791492|Other Pre-specified|Number of Participants With Clinically Significant Treatment-emergent Electrocardiogram (ECG) Findings|Clinically significant ECG findings included: corrected QT (QTc) > 450 ms, QTc >500 ms, change in QTc between 30 and 60 ms, change in QTc greater than or equal to 60 ms.|Baseline, Day 1 up to Month 12 (anytime on-treatment)|Safety population included participants who received at least one dose of study medication. ‘n’ signifies participants for this measure at specified time point for each arm group.||participants|||Number
779435|NCT00791492|Other Pre-specified|Number of Participants With Clinically Significant Treatment-emergent Echocardiography (ECHO) Findings|Clinically significant ECHO findings included: LV posterior wall thickness greater than or equal to (>=)13 mm, LV septal thickness >= 13 mm, right ventricular thickness >= 7 mm, ratio of peak mitral early diastolic and atrial contraction velocity (E/A ratio) >= 2, prime septal (E/E) >15, ejection fraction < 50 percent (%), E deceleration time <= 150 millisecond (ms), isovolumic relaxation time (IVRT) <= 70 ms, any valve thickening (> trace regurgitation in mitral, aortic, pulmonary, or tricuspid valves), abnormal respiratory variation of inferior vena cava, pericardial effusion.|Baseline, Day 1 up to Month 12 (anytime on-treatment)|Safety population included participants who received at least one dose of study medication. 'N' (number of participants analyzed) signifies participants evaluable for this measure. ‘n’ signifies participants evaluable for this measure at the specified time point for each arm group.||participants|||Number
779436|NCT00791492|Other Pre-specified|Number of Participants With Treatment-emergent Adverse Events Greater Than or Equal to Grade 3|AE=any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Grade 3 (Severe) events=unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4 (Life-threatening) events caused participant to be in imminent danger of death. Grade 5 (Death) events=death related to an AE. Treatment-emergent events=between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to 30 days after last dose of study medication|Safety population included participants who received at least one dose of study medication.||participants|||Number
779691|NCT00793585|Primary|Change in Renal Function as Measured With eGFR||baseline and 6 months|||eGFR(min/ml)||Standard Deviation|Mean
792488|NCT00892957|Secondary|Laboratory Values Over Time: Hemoglobin||Preoperative baseline through postoperative Day 14|Safety Analysis Data Set||g/dL||Full Range|Median
779441|NCT00791492|Secondary|Change From Baseline in Troponin I Concentration at Week 6, Month 3, 6 and 12|Troponin I was biomarker of cardiac stress (myocardial necrosis and increased filling pressures/ left ventricular [LV] wall stress).|Baseline, Week 6, Month 3, 6, 12|Safety population included participants who received at least one dose of study medication. 'N' (number of participants analyzed) signifies participants evaluable for this measure. ‘n’ signifies participants evaluable for this measure at the specified time point for each arm group.||nanogram/milliliter (ng/mL)||Full Range|Median
779442|NCT00791492|Secondary|Change From Baseline in Modified Body Mass Index (mBMI) at Month 6 and 12|BMI was calculated by weight divided by height squared. mBMI was calculated by multiplying BMI by serum albumin levels to compensate for edema formation. A progressive decline in mBMI indicated worsening of disease severity.|Baseline, Month 6, 12|ITT population included all participants who received at least one dose of study medication and had no more than 2 months interruption between studies FX-005 and FX-006. 'N' (number of participants analyzed) signifies participants evaluable for this measure. ‘n’ signifies participants for this measure at specified time point for each arm group.||(kilogram/square meter)*(gram/liter)||Standard Deviation|Mean
779443|NCT00791492|Secondary|Change From Baseline in Summated 3 Score for Small Nerve Fiber Function at Month 6 and 12|Summated 3 Nerve Tests Small Fiber Normal Deviates Score (NTSFnds) included cooling threshold for the lower limbs, heat pain threshold for the lower limbs and HRDB. Total score range= -11.2 to 11.2, where higher score=worse nerve function.|Baseline, Month 6, 12|ITT population included all participants who received at least one dose of study medication and had no more than 2 months interruption between studies FX-005 and FX-006. 'N' (number of participants analyzed) signifies participants evaluable for this measure. ‘n’ signifies participants for this measure at specified time point for each arm group.||units on a scale||Standard Deviation|Mean
779444|NCT00791492|Secondary|Change From Baseline in Summated 7 Score for Large Nerve Fiber Function at Month 6 and 12|Summated 7 score: composite score included five Nerve Conduction Studies (NCS) attributes (peroneal nerve distal motor latency, peroneal nerve compound muscle action potential, peroneal nerve motor conduction velocity, tibial nerve distal motor latency, and sural nerve sensory nerve action potential amplitude) along with Vibration Detection Threshold (VDT) obtained in great toes, and Heart Rate Response to Deep Breathing (HRDB) value. Score was determined through reference to normal values for age, sex and height. Total score range= -26 to 26, where higher score=worse nerve function.|Baseline, Month 6, 12|ITT population included all participants who received at least one dose of study medication and had no more than 2 months interruption between studies FX-005 and FX-006. 'N' (number of participants analyzed) signifies participants evaluable for this measure. ‘n’ signifies participants for this measure at specified time point for each arm group.||units on a scale||Standard Deviation|Mean
779445|NCT00791492|Secondary|Change From Baseline in Norfolk Quality of Life – Diabetic Neuropathy (QOL-DN) Domain Scores at Month 6 and 12|Norfolk QOL-DN: 35-item participant-rated questionnaire to assess impact of DN on QOL; Item 1-7:scored as 1=symptoms present, 0=symptoms absent. Item 8-35:scored on 5-point Likert scale: 0=no problem,4=severe problem (except item 32: -2=much better, 0=about same, 2=much worse). Norfolk QOL-DN summarized in 5 domains(score range):physical functioning/large fiber neuropathy(-2 to 58), activities of daily living(ADLs) (0 to 20), symptoms(0 to 32), small fiber neuropathy(0 to 16), autonomic neuropathy(0 to 12); higher score=greater impairment,for each. Total score=-2 to138(higher score=worse QOL).|Baseline, Month 6, 12|ITT population included all participants who received at least one dose of study medication and had no more than 2 months interruption between studies FX-005 and FX-006. 'N' (number of participants analyzed) signifies participants evaluable for this measure. ‘n’ signifies participants for this measure at specified time point for each arm group.||units on a scale||Standard Deviation|Mean
779446|NCT00791492|Secondary|Change From Baseline in Neuropathy Impairment Score - Lower Limb (NIS-LL) Score at Month 6 and 12|NIS-LL: assessed muscle weakness, reflexes and sensation; scored separately for left and right limbs. Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) are scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae) and sensation (touch pressure, pin-prick, vibration, joint position) were scored 0 = normal, 1= decreased, or 2 = absent. Total possible NIS-LL score range 0-88, higher score=greater impairment.|Baseline, Month 6, 12|ITT population included all participants who received at least one dose of study medication and had no more than 2 months interruption between studies FX-005 and FX-006. 'N' (number of participants analyzed) signifies participants evaluable for this measure. ‘n’ signifies participants for this measure at specified time point for each arm group.||units on a scale||Standard Deviation|Mean
779447|NCT00791492|Primary|Change From Baseline in Norfolk Quality of Life- Diabetic Neuropathy (QOL-DN) Total Quality of Life (TQOL) Score at Month 12|Norfolk QOL-DN: 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy; Item 1 to 7: related to symptoms and presence of symptoms was assessed as 1 and absence was assessed as 0. Item 8-35: related to activities of daily living and scored on a 5-point Likert scale, where 0= no problem and 4= severe problem (except item 32, where -2= much better, 0=about the same, 2=much worse). TQOL= sum of all the items, total possible score range= -2 to 138, where higher score=worse quality of life.|Baseline, Month 12|ITT population included all participants who received at least one dose of study medication and had no more than 2 months interruption between studies FX-005 and FX-006. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||units on a scale||Standard Deviation|Mean
779448|NCT00791492|Primary|Change From Baseline in Norfolk Quality of Life- Diabetic Neuropathy (QOL-DN) Total Quality of Life (TQOL) Score at Month 6|Norfolk QOL-DN: 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy; Item 1 to 7: related to symptoms and presence of symptoms was assessed as 1 and absence was assessed as 0. Item 8-35: related to activities of daily living and scored on a 5-point Likert scale, where 0= no problem and 4= severe problem (except item 32, where -2= much better, 0=about the same, 2=much worse). TQOL= sum of all the items, total possible score range= -2 to 138, where higher score=worse quality of life.|Baseline, Month 6|ITT population included all participants who received at least one dose of study medication and had no more than 2 months interruption between studies FX-005 and FX-006. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||units on a scale||Standard Deviation|Mean
779449|NCT00791492|Primary|Percentage of Participants With Response to Treatment as Measured by Neuropathy Impairment Score - Lower Limb (NIS-LL) at Month 12|Response to treatment indicated by either improvement(decrease from baseline) or stabilization(change from baseline of 0 to less than[<] 2) in NIS-LL score,based on mean of 2 scores in 1 week period.NIS-LL assessed muscle weakness,reflexes,sensation.Each item scored separately for left,right limbs.Components of muscle weakness:0(normal)-4(paralysis),higher score=more weakness;reflexes,sensation:0=normal,1=decreased,or 2=absent.Total NIS-LL score range 0-88,higher score=more impairment. For tafamidis-tafamidis group, NIS-LL baseline value of previous study FX-005(NCT00409175) used as reference.|Month 12|ITT population included all participants who received at least one dose of study medication and had no more than 2 months interruption between studies FX-005 and FX-006. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||percentage of participants||95% Confidence Interval|Number
779450|NCT00791492|Primary|Percentage of Participants With Response to Treatment as Measured by Neuropathy Impairment Score - Lower Limb (NIS-LL) at Month 6|Response to treatment indicated by either improvement(decrease from baseline) or stabilization(change from baseline of 0 to less than[<] 2) in NIS-LL score,based on mean of 2 scores in 1 week period.NIS-LL assessed muscle weakness,reflexes,sensation.Each item scored separately for left,right limbs.Components of muscle weakness:0(normal)-4(paralysis),higher score=more weakness;reflexes,sensation:0=normal,1=decreased,or 2=absent.Total NIS-LL score range 0-88,higher score=more impairment. For tafamidis-tafamidis group, NIS-LL baseline value of previous study FX-005(NCT00409175) used as reference.|Month 6|Intent-to-treat (ITT) population included all participants who received at least one dose of study medication and had no more than 2 months interruption between studies FX-005 and FX-006. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||percentage of participants||95% Confidence Interval|Number
779451|NCT00791518|Secondary|Number of Participants With Reports of Diagnosis and/or Treatment for Specific Cardiovascular (Heart), Psychiatric (Anxiety or Depression), and/or Bone Disorders in the <80%, >=80%, <50%, and >=50% FEV1 Groups|The number of participants with the indicated affected medical conditions were counted.|Day 1 of a 1-day study|All participants enrolled in the study who had an acceptable post-albuterol FEV1 measure||participants|||Number
779452|NCT00791518|Secondary|Mean Number of Puffs From All Short-acting Bronchodilators Used in the Past Two Weeks in Participants With an FEV1 of <50% and >=50%|The average number of puffs from all short-acting bronchodilators used in the past 2 weeks was calculated.|Day 1 of a 1-day study|All participants enrolled in the study who had an acceptable post-albuterol FEV1 measure||puffs||Standard Error|Mean
779453|NCT00791518|Secondary|Mean Puffs From All Short-acting Bronchodilators Used in the Past Two Weeks in Participants With an FEV1 of <80% and >=80%|The average number of puffs from all short-acting bronchodilators used in the past 2 weeks was calculated.|Day 1 of a 1-day study|All participants enrolled in the study who had an acceptable post-albuterol FEV1 measure||puffs||Standard Error|Mean
779454|NCT00791518|Secondary|Number of Participants Who Had a COPD Exacerbation Requiring Oral Corticosteroids and/or Antibiotics With Post-albuterol FEV1 <50% and >=50%|The number of participants with a COPD exacerbation (worsening of COPD symptoms) requiring treatment with oral corticosteroids and/or antibiotics was calculated.|Day 1 of 1-day study|All participants enrolled in the study who had an acceptable post-albuterol FEV1 measure||participants|||Number
779455|NCT00791518|Secondary|Number of Participants Who Had a COPD Exacerbation Requiring Oral Corticosteroids and/or Antibiotics With Post-albuterol FEV1 <80% and >=80%|The number of participants with a COPD exacerbation (worsening of COPD symptoms) requiring treatment with oral corticosteroids and/or antibiotics was calculated.|Day 1 of 1-day study|All participants enrolled in the study who had an acceptable post-albuterol FEV1 measure||participants|||Number
779456|NCT00791518|Secondary|Number of Participants Who Had a COPD Exacerbation Requiring Hospitalization With Post-albuterol FEV1 <50% and >=50%|The number of participants who had a COPD exacerbation (defined as worsening of COPD symptoms) requiring hospitalization was calculated.|Day 1 of 1-day study|All participants enrolled in the study who had an acceptable post-albuterol FEV1 measure||participants|||Number
779457|NCT00791518|Secondary|Number of Participants Who Had a COPD Exacerbation Requiring Hospitalization With Post-albuterol FEV1 <80% and >=80%|The number of participants who had a COPD exacerbation (defined as worsening of COPD symptoms) requiring hospitalization was calculated.|Day 1 of a 1-day study|All participants enrolled in the study who had an acceptable post-albuterol FEV1 measure||participants|||Number
779458|NCT00791518|Secondary|Mean mMRC Dyspnea Scale Scores for Participants With Post-albuterol FEV1 <50% and >=50%|The 5-point mMRC Dyspnea Scale measures the level of dyspnea (trouble breathing) experienced by participants. Scores range from 0 (none) to 4 (very severe).|Day 1 of a 1-day study|All participants enrolled in the study who had an mMRC score with post-albuterol FEV1 <50% and >=50% predicted||points on a scale||Standard Error|Mean
779459|NCT00791518|Secondary|Mean Modified Medical Research Council (mMRC) Dyspnea Scale Scores for Participants With Post-albuterol FEV1 <80% and >=80%|The 5-point mMRC Dyspnea Scale measures the level of dyspnea (trouble breathing) experienced by participants. Scores range from 0 (none) to 4 (very severe).|Day 1 of a 1-day study|All participants enrolled in the study who had an mMRC score with post-albuterol FEV1 <80% and >=80% percent predicted||points on a scale||Standard Error|Mean
779460|NCT00791518|Secondary|Number of Participants With the Categorized Post-albuterol Forced Expiratory Volume in One Second/Forced Vital Capacity (FEV1/FVC) Ratios|The ratio is calculated as the amount of air expelled from the lungs in one second after a full inspiration (FEV1) divided by the volume of air that can forcibly be blown out after a full inspiration (FVC).|Day 1 of a 1-day study|All participants enrolled in the study who had a post-albuterol FEV1 measurement. Some participants had unacceptable post-albuterol spirometry measurements and were not included in this analysis.||participants|||Number
779478|NCT00791661|Secondary|Mean Maximum Plasma Concentration (Cmax) After a Single Dose of MK-1006|The placebo group was not evaluated for this outcome measure.|Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose)|Participants received a singe dose of MK-1006 following an overnight fast (for approximately 10 hours), except the MK-1006 60 mg fed arm in which participants received a single dose of MK-1006 following the consumption of a standard Japanese breakfast. The same participant may appear in more than one treatment arm.||nM||Standard Deviation|Mean
779461|NCT00791518|Secondary|Percentage of Participants Whose Post-albuterol FEV1 Was <50% Predicted Normal|The percentage of participants on long-acting bronchodilator (LABD) monotherapy who met spirometric criteria for chronic obstructive pulmonary disease (COPD) and who had a post-albuterol FEV1 (the amount of air expelled from the lungs in one second after a full inspiration) <50% predicted normal was calculated. Predicted normal values for FEV1 were calculated using the reference values from the third National Health and Nutrition Examination Survey (NHANES III). Values are based on the participants' age, height, sex, and race; thus, normal values vary based on participants' demographics.|Day 1 of a 1-day study; 15-30 min post-albuterol (self-administered)|All participants enrolled in the study who had a post-albuterol FEV1 measurement. Some participants had unacceptable post-albuterol spirometry measurements and were not included in this analysis.||percentage of participants|||Number
779462|NCT00791518|Primary|Percentage of Participants Whose Post-albuterol Forced Expiratory Volume in One Second (FEV1) Was <80% Predicted Normal|The percentage of participants on long-acting bronchodilator (LABD) monotherapy who had a post-albuterol FEV1) <80% predicted normal was calculated. FEV1 is the amount of air that can be expelled from the lungs in one second after a full inspiration. Predicted normal values for FEV1 were calculated using the reference values from the third National Health and Nutrition Examination Survey (NHANES III). Values are based on the participants' age, height, sex, and race; thus, normal values vary based on participants' demographics.|Day 1 of a 1-day study; 15-30 min post-albuterol (self-administered)|All participants enrolled in the study who had a post-albuterol FEV1 measurement. Some participants had unacceptable post-albuterol spirometry measurements and were not included in this analysis.||percentage of participants|||Number
779463|NCT00791557|Primary|The Efficacy of Infliximab in Pyoderma Gangrenosum in Adult Subjects Who Have Inflammatory Bowel Disease|Outcome was measured by clinical assessment of pyoderma gangrenosum. The number of patients who had improvement and/or clearance of the pyoderma grangrenosum after the infusions and through the follow up visit was assessed.|Week 26|Subjects who completed all required transfusions of infliximab were analyzed.||participants|||Number
779464|NCT00791648|Secondary|Mitochondrial Function|mtDNA copy number, lactate / pyruvate ratio, PGC-1alpha RNA expression|at randomization, anesthesia induction, 30 minutes into cardiopulmonary bypass (CPB), after CPB, ICU admission, 6 hours postop, and POD 1, 2, 3.||07/2017||||
779465|NCT00791648|Secondary|Plasma and Urine Markers of Oxidative Stress (f2-Isoprostanes, Isofurans)||at randomization, anesthesia induction, 30 minutes into cardiopulmonary bypass (CPB), after CPB, ICU admission, 6 hours postop, and POD 1, 2, 3.||07/2017||||
779466|NCT00791648|Secondary|Number of Participants That Died||until postoperative hospital discharge (about 7 days)|||Participants|||Count of Participants
779467|NCT00791648|Secondary|Number of Participants With Stroke||while in ICU (about 2 days)|||Participants|||Count of Participants
779468|NCT00791648|Secondary|Liver Enzyme: Aspartate Aminotransferase Level||postoperative day 1|||units/liter||95% Confidence Interval|Median
779469|NCT00791648|Secondary|Plasma Markers of Inflammation||at randomization, anesthesia induction, 30 minutes into cardiopulmonary bypass (CPB), after CPB, ICU admission, 6 hours postop, and POD 1, 2, 3.||12/2017||||
779470|NCT00791648|Secondary|Urine Markers of Renal Injury||at randomization, anesthesia induction, 30 minutes into cardiopulm bypass (CPB), after CPB, ICU admission, 6 hours postop, 12 hours postop, and Post op Day (POD) 1, 2, 3.||04/2018||||
779471|NCT00791648|Secondary|Number of Participants Requiring Dialysis||while in ICU (about 2 days)|||Participants|||Count of Participants
779472|NCT00791648|Primary|Number of Participants With Delirium||while in ICU (about 2 days)|||Participants|||Count of Participants
779473|NCT00791648|Primary|Number of Participants With Acute Kidney Injury||postoperative day 2|||Participants|||Count of Participants
779474|NCT00791661|Secondary|24-hour Weighted Mean Glucose (WMG) Concentration|Weighted mean glucose concentration was calculated as the 24-hour area under the plasma concentration-time curve divided by 24.|Up to 36 hours|Participants received a singe dose of MK-1006 following an overnight fast (for approximately 10 hours), except the MK-1006 60 mg fed arm in which participants received a single dose of MK-1006 following the consumption of a standard Japanese breakfast. The same participant may appear in more than one treatment arm.||mg/dL||95% Confidence Interval|Least Squares Mean
779475|NCT00791661|Primary|Number of Participants Who Discontinued Treatment Due to an Adverse Event|An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.|up to approximately 17 days|Participants who received study drug. The same participant may appear in more than one treatment arm.||participants|||Number
779476|NCT00791661|Secondary|Apparent Terminal Half-life (T 1/2) After a Single Dose of MK-1006|The apparent half-life was defined as the time required for the plasma concentration of MK-1006 to decrease 50% in the final stage of its elimination. The means and standard deviations displayed as are the harmonic means and pseudo-standard deviations, respectively. The placebo group was not evaluated for this outcome measure.|Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose)|Participants received a singe dose of MK-1006 following an overnight fast (for approximately 10 hours), except the MK-1006 60 mg fed arm in which participants received a single dose of MK-1006 following the consumption of a standard Japanese breakfast. The same participant may appear in more than one treatment arm.||hours||Standard Deviation|Mean
779477|NCT00791661|Secondary|Median Time to Maximum Plasma Concentration (Tmax) After a Single Dose of MK-1006|The placebo group was not evaluated for this outcome measure.|Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose)|Participants received a singe dose of MK-1006 following an overnight fast (for approximately 10 hours), except the MK-1006 60 mg fed arm in which participants received a single dose of MK-1006 following the consumption of a standard Japanese breakfast. The same participant may appear in more than one treatment arm.||hours||Full Range|Median
780030|NCT00784134|Secondary|Intensity of Critical Care Management - Pressors|Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.|30 days|All patients that were enrolled in CLEAR III were analyzed.||% of participants with pressors|||Number
779479|NCT00791661|Secondary|Mean Area Under the Plasma Concentration Curve From Time Zero to 24 Hours (AUC[0-24]) After a Single Dose of MK-1006|AUC(0 to 24 hours) was estimated by determining the total area under the curve of the concentration versus time curve to 24 hours post dose. The placebo group was not evaluated for this outcome measure.|Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose)|Participants received a singe dose of MK-1006 following an overnight fast (for approximately 10 hours), except the MK-1006 60 mg fed arm in which participants received a single dose of MK-1006 following the consumption of a standard Japanese breakfast. The same participant may appear in more than one treatment arm.||nM*hr||Standard Deviation|Mean
779480|NCT00791661|Secondary|Mean Area Under the Plasma Concentration Curve From Time Zero to Infinity(AUC[0-∞]) After a Single Dose of MK-1006|AUC(0-∞) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity. The placebo group was not evaluated for this outcome measure.|Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose)|Participants received a singe dose of MK-1006 following an overnight fast (for approximately 10 hours), except the MK-1006 60 mg fed arm in which participants received a single dose of MK-1006 following the consumption of a standard Japanese breakfast. The same participant may appear in more than one treatment arm.||nM*hr||Standard Deviation|Mean
779481|NCT00791661|Primary|Number of Participants Who Experienced at Least One Adverse Event|An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.|from the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to approximately 31 days)|Participants who received study drug. The same participant may appear in more than one treatment arm.||participants|||Number
779482|NCT00791700|Secondary|Optimized Background Treatment (OBT) Susceptibility Scores (Net/Overall) by Outcome|Outcome (Response, PDVF or other/remainder) was summarized by the total ARV activity of the background regimen using simple and weighted totals (TOBT and p-wTOBTss, respectively) in the aggregate, categorized as 0, 1, ≥2 (TOBT) and 0 0.5, 1 1.5 and ≥2 (p-wOBTss) respectively, as well as by screening genotype. Six participants (Response: n=5; Other failure: n=1) failed to have successful PhenoSense GT analysis at screening, and so a net susceptibility score was not generated. One more participant was not included in the wOBTss analysis due to failed phenotype analysis. However, net susceptibility scores were imputed for simple analysis based on genotype. Susceptibility scores indicate the level resistance to the study medication. Scores include: 1 = susceptible and potential low-level resistance; 0.5 = low and intermediate-level resistance; 0 = high-level resistance.|48 weeks|The FAS consisted of all participants who received at least 1 dose of study drug (same as APS 4).||Percentage of participants|||Number
779483|NCT00791700|Secondary|Summary of the Emergence of Reverse Transcriptase Inhibitor (RTI) and Protease Inhibitor (PI) Resistance Associated Mutations (RAMs) Between Screening and On-Treatment Confirmed PDVF: Total and by Cohort Prior to Week 48|Phenotypic and genotypic susceptibility to reverse transcriptase and protease inhibitors was evaluated at screening using the Monogram Biosciences PhenoSense™ GT (PSGT) assay. Samples from a confirmatory PDVF visit or early termination of MVC were planned to be analyzed if the plasma HIV-1 RNA was ≥400 copies/mL. Participants with more than one mutation are counted more than once.|48 weeks|"The FAS consisted of all participants who received at least 1 dose of study drug (same as APS 4).
One participant was excluded from summary tables as classified as MSDF response; one participant was analyzed after stopping treatment."||Number of participants|||Number
779484|NCT00791700|Secondary|Shift Table of Viral Tropism Between Screening and Confirmed PDVF Prior to Week 48|Virus tropism was determined using the Monogram Biosciences Trofile™ viral tropism assay. A shift table of the change in detected tropism from screening to the time of failure was produced in the aggregate and also broken down by age cohort.|Screening and Week 48|Participants who experienced confirmed PDVF through Week 48 with sufficient plasma HIV-1 RNA for virology analysis while receiving MVC. One participant was excluded from summary tables as classified as MSDF response; one participant was analyzed after stopping treatment.||Number of participants|||Number
779485|NCT00791700|Secondary|Protocol Defined Virologic Failure|"The occurrence of any one of the following criteria would constitute Virologic failure:
A=Decrease from Baseline plasma HIV-1 RNA <1 log10 and plasma HIV-1 RNA >400 copies/mL starting at Week 12 and confirmed at consecutive Week 16; B=Decrease from Baseline plasma HIV-1 RNA <2.0 log10 and plasma HIV-1 RNA >400 copies/mL at Week 24 OR plasma HIV-1 RNA >10,000 copies/mL on and after Week 24, and confirmed within 14 to 21 days; C=Increase from nadir plasma HIV-1 RNA of >=1 log10 (>=1,000 copies/mL if nadir plasma HIV-1 RNA <48 copies/mL) at any time, and confirmed within 14 to 21 days."|Week 48|The FAS consisted of all participants who received at least 1 dose of study drug (same as APS 4).||Number of participants|||Number
779486|NCT00791700|Secondary|Change From Baseline in CD4+ Percent (%) at Weeks 24 and 48|Change from baseline in CD4 % to Week 24 and Week 48 were tabulated in aggregated and broken down by age cohort using summary statistics.|Week 24 and Week 48 post-treatment|The FAS consisted of all participants who received at least 1 dose of study drug (same as APS 4). LOCF was used to impute missing values.||percentage of CD4+ cells||Standard Deviation|Mean
779487|NCT00791700|Secondary|Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count at Weeks 24 and 48|Change from baseline in CD4 cell count to Week 24 and Week 48 were tabulated in aggregated and broken down by age cohort using summary statistics.|Week 24 and Week 48 post-treatment|The FAS consisted of all participants who received at least 1 dose of study drug (same as APS 4). LOCF was used to impute missing values.||cells/mm^3||Standard Deviation|Mean
779488|NCT00791700|Secondary|Summary of Change From Baseline in HIV-1 RNA (Log10 Copies/mL) by Visit|Plasma HIV-1 RNA was determined using the Roche COBAS AmpliPrep/COBAS TaqMan HIV-1 Test (lower limit of quantification [LLOQ] <48 copies/mL). Blood samples were taken at the time points indicated in the participant evaluation schedule. Screening HIV-1 RNA >1000 copies/ml was used to determine eligibility for the study.|Week 24 and Week 48 post-treatment|The FAS consisted of all participants who received at least 1 dose of study drug (same as APS 4). LOCF was used to impute missing values.||Log10 Copies/mL||Standard Deviation|Mean
779489|NCT00791700|Secondary|Summary of Change From Baseline in HIV-1 RNA (Original) by Visit|Plasma HIV-1 RNA was determined using the Roche COBAS AmpliPrep/COBAS TaqMan HIV-1 Test (lower limit of quantification [LLOQ] <48 copies/mL). Blood samples were taken at the time points indicated in the participant evaluation schedule. Screening HIV-1 RNA >1000 copies/ml was used to determine eligibility for the study.|Week 24 and Week 48 post-treatment|The FAS consisted of all participants who received at least 1 dose of study drug (same as APS 4). LOCF was used to impute missing values.||copies/mL||Standard Deviation|Mean
779490|NCT00791700|Secondary|Percentage of Participants With >= 1.0 log10 Reduction in HIV-1RNA Concentration From Baseline to Week 24 and Week 48|Percentage of subjects with at least a 1.0 log10 reduction in HIV-1 RNA from baseline to Week 24 and Week 48 were tabulated.|Week 24 and Week 48 post-treatment|The FAS consisted of all participants who received at least 1 dose of study drug (same as APS 4). Last Observation Carried Forward (LOCF) was used to impute missing values.||percentage of participants||95% Confidence Interval|Number
779491|NCT00791700|Secondary|Percentage of Participants With HIV-1 RNA <400 Copies/mL and <48 Copies/mL Using the Time to Loss of Virologic Response Algorithm (TLOVR) at Week 48|TLOVR is defined as the time from first dose of study medication (Day 1) until the time of virologic failure using the a TLOVR algorithm.|Week 48|The FAS consisted of all participants who received at least 1 dose of study drug (same as APS 4).||Percentage of participants|||Number
779492|NCT00791700|Secondary|Percentage of Participants With HIV-1 RNA Levels < 48 Copies/mL at Weeks 24 and 48 Using MD=F Approach|Participants who have been discontinued from the study, have been lost to follow-up, or have missing HIV-1 RNA data prior to the time point of interest were considered to have HIV-1 RNA levels > lower limit of quantification (LLOQ) . This will be referred to as [non-completer = failure; NC=F] or [missing, discontinuation = failure; MD=F]. The proportion of participants (100*n/N) is reported below. The proportion of participants (100*n/N) is reported below.|Week 24 and Week 48 post-treatment|The FAS consisted of all participants who received at least 1 dose of study drug (same as APS 4).||Percentage of participants||95% Confidence Interval|Number
779493|NCT00791700|Secondary|Percentage of Participants With HIV-1 RNA Levels <400 Copies/mL at Weeks 24 and 48 Using Missing, Discontinuation = Failure (MD=F)Approach|Participants who have been discontinued from the study, have been lost to follow-up, or have missing HIV-1 RNA data prior to the time point of interest were considered to have HIV-1 RNA levels > lower limit of quantification (LLOQ) . This will be referred to as [non-completer = failure; NC=F] or [missing, discontinuation = failure; MD=F]. The proportion of participants (100*n/N) is reported below.|Week 24 and Week 48 post-treatment|The FAS consisted of all participants who received at least 1 dose of study drug (same as APS 4).||Percentage of participants||95% Confidence Interval|Number
779494|NCT00791700|Secondary|Percentage of Participants With HIV‑1 RNA <48 Copies/mL Through Week 48 (MSDF)|The proportion of participants who achieved HIV-1 RNA <48 copies/mL at week 24 or 48 was assessed according to Food and Drug Administration’s (FDA’s) Missing, Switch, Discontinuation’=Failure (MSDF) Snapshot algorithm. The algorithm uses the plasma HIV-1 RNA in the Week 24 or 48 visit window, follows the “virology-first principle” and considers a participant who has a missing plasma HIV-1 RNA, or switches to prohibited ARV regimen or discontinues from the study or study drug for any reason, or dies, as a failure. The percentage of participants is reported below.|Week 24 and Week 48 post-treatment|The FAS consisted of all participants who received at least 1 dose of study drug (same as APS 4).||percentage of participants|||Number
779495|NCT00791700|Secondary|Percentage of Participants With HIV‑1 RNA <400 Copies/mL Through Week 48 (MSDF)|The proportion of participants who achieved HIV-1 RNA <400 copies/mL at week 24 or 48 was assessed according to Food and Drug Administration’s (FDA’s) Missing, Switch, Discontinuation’=Failure (MSDF) Snapshot algorithm. The algorithm uses the plasma HIV-1 RNA in the Week 24 or 48 visit window, follows the “virology-first principle” and considers a participant who has a missing plasma HIV-1 RNA, or switches to prohibited ARV regimen or discontinues from the study or study drug for any reason, or dies, as a failure. The percentage of participants is reported below.|Week 24 and Week 48 post-treatment.|The FAS will consist of all participants who receive at least one dose of study medication (same as APS4).||percentage of participants|||Number
779496|NCT00791700|Primary|Treatment Discontinuation Secondary to Serious Adverse Event (SAE) Related to Study Drug|The primary reason for a participant discontinuing from study drug or the clinical study was recorded in the source documents as well as the case report form. A discontinuation had to be reported immediately to the study medical monitor or his/her designated representative if it was due to an SAE.|Week 48|The FAS consisted of all participants who received at least 1 dose of study drug (same as APS 4).||participants|||Number
779497|NCT00791700|Primary|Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events (All Causality)|Safety was assessed by spontaneous reports, physical examination and laboratory test results in all participants who received at least 1 dose of study drug. The investigator used the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric AEs.|48 weeks|Safety analysis was performed on all participants who received at least 1 dose of study drug.||Number of events|||Number
779498|NCT00791700|Primary|PK Parameters for Stage 1 Participants Enrolled in Stage 2 – Week 2 Results for Stage 2 Doses - Tmax (Time at Maximum Concentration)|A PK analysis was performed using PK data from participants that participated in Stage 1 (PK Populations 2 and 3) where intensive maraviroc (MVC) PK data were available at Week 2. The primary aim of this analysis was to describe and summarize MVC PK parameters (Tmax) at Week 2 and Week 48 by cohort and Optimized Background Treatment (OBT) group. Correlations between MVC PK and efficacy as well as compliance were also assessed.|Week 2 and Week 48 (0, 1, 2, 4, 6, 8, 12 hours post-dose)|PK Population 2 (subset of APS 1) consisting of all Stage 1 participants who had a Week 2 full PK profile; PK Population 3 (subset of APS 1) consisting of all Stage 1 participants who had an approved dose for Stage 2 / met the PK target.||hr||Full Range|Median
779510|NCT00791778|Other Pre-specified|EQ-5D VAS Score at Cycle 3|The EQ-5D also contains a VAS, which records the respondent’s self-rated health status on a vertical graduated scale. The scale ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).|At Cycle 3 (4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 3||Scores on a scale||Standard Deviation|Mean
780315|NCT00802529|Primary|Vertigo Attacks|The number of vertigo attacks between 18-24months follow-up were taken retrospectively during a face-to-face appointment at 24 months follow-up and compared to 6 month pre-enrollment baseline (as per Committee on Hearing and Equilibrium guidelines).|6month pre-enrollment baseline, 18-24 months after initial treatment|Intention-to-treat||Vertigo Attacks||Standard Deviation|Mean
779499|NCT00791700|Primary|PK Parameters for Stage 1 Participants Enrolled in Stage 2 – Week 2 Results for Stage 2 Doses - AUCtau (Area Under the Curve at Steady State)|A PK analysis was performed using PK data from participants that participated in Stage 1 (PK Populations 2 and 3) where intensive maraviroc (MVC) PK data were available at Week 2. The primary aim of this analysis was to describe and summarize MVC PK parameters (AUCtau) at Week 2 and Week 48 by cohort and Optimized Background Treatment (OBT) group. Correlations between MVC PK and efficacy as well as compliance were also assessed.|Week 2 and Week 48 (0, 1, 2, 4, 6, 8, 12 hours post-dose)|PK Population 2 (subset of APS 1) consisting of all Stage 1 participants who had a Week 2 full PK profile; PK Population 3 (subset of APS 1) consisting of all Stage 1 participants who had an approved dose for Stage 2 / met the PK target.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
779500|NCT00791700|Primary|Pharmacokinetic (PK) Parameters for Participants With Data in Stage 1 Enrolled in Stage 2 – Week 48|A PK analysis was performed using PK data from participants that participated in Stage 1 (PK Populations 2 and 3) where intensive maraviroc (MVC) PK data were available at Week 2. The primary aim of this analysis was to describe and summarize MVC PK parameters at Week 2 and Week 48 by cohort and Optimized Background Treatment (OBT) group. Geometric Coefficient of Variation is defined as the geometric standard deviation to the power of the reciprocal of the geometric mean.|Week 2 and Week 48 (0, 1, 2, 4, 6, 8, 12 hours post-dose)|PK Population 2 (subset of Analysis Population Set [APS] 1) consisting of all Stage 1 participants who had a Week 2 full PK profile; PK Population 3 (subset of APS 1) consisting of all Stage 1 participants who had an approved dose for Stage 2 / met the PK target.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
779501|NCT00791765|Secondary|Patient Satisfaction With Treatment at Week 12|This response scale was adapted from the Medical Outcomes Study: Patient Satisfaction Survey. To assess satisfaction with treatment, the participant was asked to check a box (from “very dissatisfied” to “very satisfied”) to indicate his or her level of satisfaction with the medication’s control of psoriasis.|12 Weeks|Intention-to-Treat with available data at week 12; last observation carried forward (LOCF) imputation was used.||participants|||Number
779502|NCT00791765|Secondary|Percent Change From Baseline in PSSI at Week 24 in Participants Switching From Placebo to Etanercept at Week 12|Percent change from baseline in Psoriasis Scalp Severity Index (PSSI) in participants switching from placebo to etanercept at Week 12 (Group B) at Week 24. The PSSI measures the extent of psoriasis involvement and the severity of erythema, infiltration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored by physicians using a scale from 0 to 72, where 0 = no psoriasis, and higher scores indicate more severe disease. The PSSI calculation does not include the face or neck area.|Baseline and Week 24|Intention-to-Treat with available data; last observation carried forward (LOCF) imputation.||Percent change||Standard Error|Mean
779503|NCT00791765|Secondary|Percentage of Participants With PSSI 75% Response at Week 12|Percentage of participants achieving at least a 75% improvement from baseline in the Psoriasis Scalp Severity Index (PSSI) at Week 12. The Psoriasis Scalp Severity Index (PSSI) measures the extent of psoriasis involvement and the severity of erythema, infiltration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored by physicians using a scale from 0 to 72, where 0 = no psoriasis, and higher scores indicating more severe disease. The PSSI calculation does not include the face or neck area. PSSI 75 indicates at least a 75% improvement in the PSSI score from baseline.|Baseline and Week 12|Intention-to-Treat with available data; last observation carried forward (LOCF) imputation||Percentage of participants|||Number
779504|NCT00791765|Primary|Percentage Change From Baseline in Psoriasis Scalp Severity Index at Week 12|The Psoriasis Scalp Severity Index (PSSI) measures the extent of psoriasis involvement and the severity of erythema, infiltration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored by physicians using a scale from 0 to 72, where 0 = no psoriasis, and higher scores indicating more severe disease. The PSSI calculation does not include the face or neck area.|Baseline and Week 12|Intention-to-Treat population (all patients who were randomized to investigational product) with available data; last observation carried forward (LOCF) imputation was used.||Percent change||Standard Error|Mean
779505|NCT00791778|Other Pre-specified|Change From Baseline in EQ-5D VAS Score at End of Treatment|The EQ-5D also contains a VAS, which records the respondent’s self-rated health status on a vertical graduated scale. The change is calculated as score at End of treatment minus baseline score. The change in EQ-5D VAS ranges from -100 (most deterioration from baseline) to 100 (most improvement from baseline).|Baseline and End of treatment (up to Cycle 33, 4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at end of treatment||Scores on a scale||Standard Deviation|Mean
779506|NCT00791778|Other Pre-specified|EQ-5D VAS Score at End of Treatment|The EQ-5D also contains a VAS, which records the respondent’s self-rated health status on a vertical graduated scale. The scale ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).|At End of treatment (up to Cycle 33, 4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at end of treatment||Scores on a scale||Standard Deviation|Mean
779507|NCT00791778|Other Pre-specified|Change From Baseline in EQ-5D VAS Score at Cycle 5|The EQ-5D also contains a VAS, which records the respondent’s self-rated health status on a vertical graduated scale. The change is calculated as score at Cycle 5 minus baseline score. The change in EQ-5D VAS ranges from -100 (most deterioration from baseline) to 100 (most improvement from baseline).|Baseline and Cycle 5 (4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 5||Scores on a scale||Standard Deviation|Mean
779508|NCT00791778|Other Pre-specified|EQ-5D VAS Score at Cycle 5|The EQ-5D also contains a VAS, which records the respondent’s self-rated health status on a vertical graduated scale. The scale ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).|At Cycle 5 (4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 5||Scores on a scale||Standard Deviation|Mean
779509|NCT00791778|Other Pre-specified|Change From Baseline in EQ-5D VAS Score at Cycle 3|The EQ-5D also contains a VAS, which records the respondent’s self-rated health status on a vertical graduated scale. The change is calculated as score at Cycle 3 minus baseline score. The change in EQ-5D VAS ranges from -100 (most deterioration from baseline) to 100 (most improvement from baseline).|Baseline and Cycle 3 (4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 3||Scores on a scale||Standard Deviation|Mean
780316|NCT00802633|Secondary|Operating Room Time in Minutes||Intraoperative time|||minutes||Standard Deviation|Mean
779512|NCT00791778|Other Pre-specified|Change From Baseline in EQ-5D Index Score at End of Treatment|The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index. The change is calculated as score at End of treatment minus baseline score. The change in EQ-5D index ranges from -1.594 (most deterioration from baseline) to 1.594 (most improvement from baseline).|Baseline and End of treatment (up to Cycle 33, 4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at end of treatment||Scores on a scale||Standard Deviation|Mean
779513|NCT00791778|Other Pre-specified|EQ-5D Index Score at End of Treatment|The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index score which ranges from -0.594 (worst) to 1 (best) when the United Kingdom (UK) weights are applied.|At End of treatment (up to Cycle 33, 4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at end of treatment||Scores on a scale||Standard Deviation|Mean
779514|NCT00791778|Other Pre-specified|Change From Baseline in EQ-5D Index Score at Cycle 5|The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index. The change is calculated as score at Cycle 5 minus baseline score. The change in EQ-5D index ranges from -1.594 (most deterioration from baseline) to 1.594 (most improvement from baseline).|Baseline and Cycle 5 (4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 5||Scores on a scale||Standard Deviation|Mean
779515|NCT00791778|Other Pre-specified|EQ-5D Index Score at Cycle 5|The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index score which ranges from -0.594 (worst) to 1 (best) when the United Kingdom (UK) weights are applied.|At Cycle 5 (4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 5||Scores on a scale||Standard Deviation|Mean
779516|NCT00791778|Other Pre-specified|Change From Baseline in EQ-5D Index Score at Cycle 3|The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index. The change is calculated as score at Cycle 3 minus baseline score. The change in EQ-5D index ranges from -1.594 (most deterioration from baseline) to 1.594 (most improvement from baseline).|Baseline and Cycle 3 (4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 3||Scores on a scale||Standard Deviation|Mean
779517|NCT00791778|Other Pre-specified|EQ-5D Index Score at Cycle 3|The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index score which ranges from -0.594 (worst) to 1 (best) when the United Kingdom (UK) weights are applied.|At Cycle 3 (4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 3||Scores on a scale||Standard Deviation|Mean
779518|NCT00791778|Other Pre-specified|EuroQol-5D (EQ-5D) Index Score at Cycle 1/Baseline|The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index score which ranges from -0.594 (worst) to 1 (best) when the United Kingdom (UK) weights are applied.|At Cycle 1 (4 weeks per Cycle)/baseline|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at least one post-baseline assessment||Scores on a scale||Standard Deviation|Mean
779519|NCT00791778|Other Pre-specified|Change From Baseline in FOSI Total Score at End of Treatment|The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The change is calculated as score at End of treatment minus baseline score. The change in FOSI total score ranges from -32 (most deterioration from baseline) to 32 (most improvement from baseline).|Baseline and End of treatment (up to Cycle 33, 4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at end of treatment||Scores on a scale||Standard Deviation|Mean
779520|NCT00791778|Other Pre-specified|FOSI Total Score at End of Treatment|The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The FOSI total score ranges from 0 (severely symptomatic) to 32 (asymptomatic).|At End of treatment (up to Cycle 33, 4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at end of treatment||Scores on a scale||Standard Deviation|Mean
779521|NCT00791778|Other Pre-specified|Change From Baseline in FOSI Total Score at Cycle 5|The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The change is calculated as score at Cycle 5 minus baseline score. The change in FOSI total score ranges from -32 (most deterioration from baseline) to 32 (most improvement from baseline).|Baseline and Cycle 5 (4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 5||Scores on a scale||Standard Deviation|Mean
779522|NCT00791778|Other Pre-specified|FOSI Total Score at Cycle 5|The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The FOSI total score ranges from 0 (severely symptomatic) to 32 (asymptomatic).|At Cycle 5 (4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 5||Scores on a scale||Standard Deviation|Mean
779523|NCT00791778|Other Pre-specified|Change From Baseline in FOSI Total Score at Cycle 3|The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The change is calculated as score at Cycle 3 minus baseline score. The change in FOSI total score ranges from -32 (most deterioration from baseline) to 32 (most improvement from baseline).|Baseline and Cycle 3 (4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 3||Scores on a scale||Standard Deviation|Mean
780317|NCT00802633|Primary|Estimated Blood Loss||Perioperative|||milliliters||Standard Deviation|Mean
792572|NCT00893971|Primary|Heart Rate Change From Baseline|Change from baseline for heart rate 12-hours post-dose Heart rate (bpm)|12 hours|All subjects in the Safety Population that had a valid measurement for the parameter||bpm||Full Range|Mean
779525|NCT00791778|Other Pre-specified|Functional Assessment of Cancer Therapy (FACT)/National Comprehensive Cancer Network (NCCN) Ovarian Symptom Index (FOSI) Total Score at Cycle 1/Baseline|The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The FOSI total score ranges from 0 (severely symptomatic) to 32 (asymptomatic).|At Cycle 1 (4 weeks per Cycle)/baseline|Patient-reported outcomes (PRO) analysis set=the FAS population with evaluable PRO assessments at baseline and at least one post-baseline assessment||Scores on a scale||Standard Deviation|Mean
779526|NCT00791778|Secondary|Overall Survival (OS)|The OS time was measured from the date of randomization until the date of death due to any cause. Patients who were alive at the time of analysis were censored at the date of the last contact (last time the patient was known to be alive).|From randomization of the first patient until 32.5 months later|FAS=all randomized participants||Days||95% Confidence Interval|Median
779527|NCT00791778|Secondary|Time to First Pathologic CA-125 (Cancer-associated Tumor Marker) Serum Level|Time from randomization to the first documented increase of CA-125 above the upper limit of normal. Patients without pathologic CA-125 increase at the time of analysis were censored at their last date of evaluation of CA-125.|From randomization of the first patient until 32.5 months later, assessed every 8 weeks|Per protocol set (PPS)=all randomized participants who had normal CA-125 serum level at baseline and at least one post-baseline CA-125 assessment||Days||95% Confidence Interval|Median
779528|NCT00791778|Primary|Progression-free Survival (PFS), Based on Radiological or Pathologic Assessment|Time from randomization to the first documented disease progression by radiological or pathologic assessment or death due to any cause whichever occurred first. For patients who had not progressed or died at the time of analysis, PFS was censored at the date of their last evaluable tumor scan.|From randomization of the first patient until 32.5 months later, assessed every 8 weeks|Full analysis set (FAS)=all randomized participants||Days||95% Confidence Interval|Median
779529|NCT00791817|Primary|Cmax|Maximum plasma concentration after a single dose|over 12 hours|||ng/mL||Standard Deviation|Geometric Mean
779530|NCT00791908|Primary|Mean Changes in Color, Texture, and Size of Cherry Angiomata From Baseline to 3 Months After the Second Treatment by Treatment Type as Assessed by Blinded Raters|Each subject received all 3 treatments. Serial standardized photographs evaluated for color,texture and size by 2 blinded dermatologists using ordinal visual analog scales from 0 to 10(color: 0=skin colored, 5=red, 10=purple; texture: 0=flat, 5=mildly elevated, 10=elevated; size: 0=0mm, 10=10 mm).|Baseline and 3 months|||Units on a scale||Full Range|Mean
779531|NCT00791921|Secondary|American College of Rheumatology 20% (ACR20) Response at Week 24|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1)Health Assessment Questionnaire-Disability Index (HAQ-DI), 2)C-reactive Protein (CRP), 3) Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS)|Baseline, Week 24|All 230 subjects (116 CDP 200 mg, 114 Placebo) included in the Full Analysis Set (FAS) are included in this analysis||percentage of participants|||Number
779532|NCT00791921|Primary|American College of Rheumatology 20% (ACR20) Response at Week 12|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1)Health Assessment Questionnaire-Disability Index (HAQ-DI), 2)C-reactive Protein (CRP), 3) Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS)|Baseline, Week 12|All 230 subjects (116 CDP 200 mg, 114 Placebo) included in the Full Analysis Set (FAS) are included in this analysis||percentage of participants|||Number
779533|NCT00791934|Secondary|Mean Intra-patient Change in SNOT-20 Score Post-procedure Compared to Baseline|The 20 question Sino-Nasal Outcome Test (SNOT-20) will be used to evaluate sinus symptoms and sinus-symptom related quality of life (QOL) at baseline, 10 weeks, and 1 year post-procedure. The change in SNOT-20 score at each post-procedure time point will be evaluated compared to baseline SNOT-20 score. Each of the 20 questions in the SNOT-20 survey is scored on a scale of 0 to 5, where '0' represents 'no problem' and '5' represents 'problem as bad as it can be'. The 20 questions are expressed as a mean of the scores. Therefore, the minimum mean score is zero and the maximum mean score is 5.|10 weeks|The analysis population consists of the 58 subjects with 10 week post-procedure SNOT-20 scores available for analysis.||scores on a scale||Standard Deviation|Mean
779534|NCT00791934|Secondary|Mean Intra-patient Change in SNOT-20 Score Post-procedure Compared to Baseline|The 20 question Sino-Nasal Outcome Test (SNOT-20) will be used to evaluate sinus symptoms and sinus-symptom related quality of life (QOL) at baseline, 10 weeks, and 1 year post-procedure. The change in SNOT-20 score at each post-procedure time point will be evaluated compared to baseline SNOT-20 score. Each of the 20 questions in the SNOT-20 survey is scored on a scale of 0 to 5, where '0' represents 'no problem' and '5' represents 'problem as bad as it can be'. The 20 questions are expressed as a mean of the scores. Therefore, the minimum mean score is zero and the maximum mean score is 5.|1 year|The analysis population consists of the 47 subjects with 1 year post-procedure SNOT-20 scores.||scores on a scale||Standard Deviation|Mean
779535|NCT00791934|Secondary|Number of Participants With Either a Change in Intraocular Pressure (IOP) ≥10mmHg OR Documented IOP > 21 mmHg|Change in Intra-Ocular Pressure (IOP) of ≥ 10mmHg or documented IOP of > 21 mmHg were considered clinically significant (baseline compared to 10 weeks post-procedure).|10 weeks post-procedure|The analysis population includes paired data for 53 of the 63 subjects with intraocular pressure (IOP) evaluations available for analysis.||participants|||Number
779536|NCT00791934|Secondary|Number of Participants With Decrease in Vision Greater Than 2 Lines Per Snellen Chart (BCVA at Baseline vs. BCVA 10 Week Post-procedure)|The Snellen eye chart will be used to evaluate participant's best-corrected visual acuity (BCVA, or best distance vision with eyeglasses or contact lenses) at baseline and at 10 week post-procedure. The number of participants with a decrease in vision greater than 2 lines per the Snellen eye chart are reported for this study endpoint.|10 weeks post surgery|The analysis population includes paired data for 53 subjects with baseline and 10 week visual acuity data available for analysis.||participants|||Number
784953|NCT00834132|Primary|Cmax - Maximum Observed Concentration - Azithromycin in Plasma|Bioequivalence based on Cmax|Blood samples collected over 168 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
779537|NCT00791934|Primary|Mean Intrapatient Change in Ethmoid Lund-MacKay CT Score (Ethmoid Score Only) at 10 Weeks Post-procedure Compared to Baseline.|The Lund-MacKay (LMK) CT (computed tomography) scoring system is used to evaluate radiographic opacification of the paranasal sinuses, an indicator of sinus disease. The LMK scoring system rates each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses on a scale of 0 to 2, where '0' is 'no opacification' and '2' is 'complete opacification'. For this study endpoint, only the ethmoid sinus scores will be evaluated and totaled (left and right anterior and posterior ethmoid sinuses) where zero is the minimum score, and 8 is the maximum score. A higher score represents greater sinus disease burden. The LMK score will be evaluated at 10 weeks post-procedure compared to baseline.|10 weeks post-procedure|A total of 58 of the 63 subjects had paired baseline and 10 week post-procedure CT scans available for analysis.||scores on a scale||Standard Deviation|Mean
779538|NCT00791973|Secondary|Total Eye Symptom Scores After Antigen Challenge|Watery and itchy eye symptoms will be scored based on the following scale: 0=no symptoms, 1= mild, 2= moderate, 3= severe|After one week of treatment wtih veramyst or placebo|||units on a scale||Inter-Quartile Range|Median
779539|NCT00791973|Primary|Change in Tryptase Level From Baseline to Post-antigen Challenge|Tryptase levels (mcg/L) were measured from nasal lavages|After one week of treatment wtih veramyst or placebo|||mcg/L||Inter-Quartile Range|Median
779540|NCT00791999|Secondary|American College of Rheumatology 20% (ACR20) Response at Week 24|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1)Health Assessment Questionnaire-Disability Index (HAQ-DI), 2)C-reactive Protein (CRP), 3) Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS)|Baseline, Week 24|All 316 subjects (72 CDP 100 mg, 82 CDP 200 mg, 85 CDP 100 mg, 77 Placebo) included in the Full Analysis Set (FAS) are included in this analysis||percentage of participants|||Number
779541|NCT00791999|Primary|American College of Rheumatology 20% (ACR20) Response at Week 12|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1)Health Assessment Questionnaire-Disability Index (HAQ-DI), 2)C-reactive Protein (CRP), 3) Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS)|Baseline, Week 12|All 316 subjects (72 CDP 100 mg, 82 CDP 200 mg, 85 CDP 100 mg, 77 Placebo) included in the Full Analysis Set (FAS) are included in this analysis||percentage of participants|||Number
779542|NCT00792103|Secondary|Photophobia Free|Photophobia free at two hours after patch activation.|2 hours|Per protocol, the intent-to-treat population was defined as all subjects who applied and activated at least one NP101 study patch and had at least one post baseline assessment for each migraine symptom (pain, photophobia, phonophobia, and nausea). Two treated subjects in the safety population did not meet this criteria.||participant|||Number
779543|NCT00792103|Secondary|Phonophobia Free|Phonophobia free at two hours after patch activation.|2 hours|Per protocol, the intent-to-treat population was defined as all subjects who applied and activated at least one NP101 study patch and had at least one post baseline assessment for each migraine symptom (pain, photophobia, phonophobia, and nausea). Two treated subjects in the safety population did not meet this criteria.||participants|||Number
779544|NCT00792103|Secondary|Nausea Free|Nausea free at two hours after patch activation.|2 hours|Per protocol, the intent-to-treat population was defined as all subjects who applied and activated at least one NP101 study patch and had at least one post baseline assessment for each migraine symptom (pain, photophobia, phonophobia, and nausea). Two treated subjects in the safety population did not meet this criteria.||participants|||Number
779545|NCT00792103|Primary|Subject Self-examination of Skin Irritation|For each patch application, subjects performed a self-examination of skin irritation using a 5-point scale (0=no redness; 1=minimal skin redness; 2=moderate skin redness with sharp borders; 3=intense skin redness with or without swelling; 4=intense skin redness with blisters or broken skin).|24 hours post patch activation|Per protocol, the intent-to-treat population was defined as all subjects who applied and activated at least one NP101 study patch and had at least one post baseline assessment for each migraine symptom (pain, photophobia, phonophobia, and nausea).||scores on a scale|Participants|Standard Deviation|Mean
779546|NCT00792103|Secondary|Pain Relief|Headache pain relief (no pain or mild headache pain) at two hours post activation of NP101.|2 hours|Per protocol, the intent-to-treat population was defined as all subjects who applied and activated at least one NP101 study patch and had at least one post baseline assessment for each migraine symptom (pain, photophobia, phonophobia, and nausea). Two treated subjects in the safety population did not meet this criteria.||participants|||Number
779547|NCT00792116|Primary|Math Grades||14 week (end of the semester)|106 participants were analyzed. One particiapant relocated to another school and one participant was removed by the teacher for discipline reasons.||average percentage correct||Standard Deviation|Mean
779548|NCT00792116|Primary|Math Scores on the Texas Assessment of Knowledge and Skills (TAKS).|The TAKS test is a statewide standardized test administered to all Texas schoolchildren (15). The TAKS assesses reading, math, science, and social studies for 8th grade students; however, the current study analyzed only math scores.|14 weeks (end of the semester)|106 participants were analyzed. One particiapant relocated to another school and one participant was removed by the teacher for discipline reasons.||percentile||Standard Deviation|Mean
779549|NCT00792116|Secondary|State Anxiety Scores on the State Trait Anxiety Index for Children (STAIC).|The STAIC is a scale that distinguishes between a situationally based anxiety and a general intrinsic inclination towards experiencing feelings of anxiety|the beginning of a school semester and 14 weeks later (the end of a school semester)||||||
779550|NCT00792116|Secondary|Scores on the Math Anxiety Rating Scale for Adolescents (MARS-A)|he MARS-A (12) is a 98-item scale that lists various everyday situations in which adolescents may have to use mathematics.|the beginning of a school semester and 14 weeks later (the end of a school semester)||||||
779551|NCT00792116|Secondary|Math Scores on the Woodcock Johnson III Tests of Achievement (WJ-III)|The WJ-III (10) is a standardized test battery used to assess an individual’s academic strengths and weaknesses. For purposes of the current study, students were given the 4 math subtests of the WJ-III.|the beginning of a school semester and 14 weeks later (the end of a school semester)||||||
779553|NCT00792116|Primary|Math Scores on the Texas Assessment of Knowledge and Skills (TAKS)|The TAKS test is a statewide standardized test administered to all Texas schoolchildren (15). The TAKS assesses reading, math, science, and social studies for 8th grade students; however, the current study analyzed only math scores.|the beginning of a school semester|106 participants were analyzed. One particiapant relocated to another school and one participant was removed by the teacher for discipline reasons.||percentile||Standard Deviation|Mean
779554|NCT00792259|Primary|Precision and Agreement Between the Topcon 3D OCT 1000 and the Identified Predicate Device|"The precision and agreement measures the thickness of RNFL and Full Retinal Thickness of the study device and is compared to the predicate device to show agreement.
Keywords, ILM - Internal Limiting Membrane RPE - Retinal Pigment Epithelium RNFL - Retinal Nerve Fiber Layer"|30 Minutes|||µm||Standard Deviation|Mean
779555|NCT00792298|Post-Hoc|LS Mean Latency to the Onset of Persistent Sleep (LPS) During Period 1 (To Exclude Carryover Effect)|LPS is defined as the duration of time measured in minutes from lights off to persistent sleep onset. In order to evaluate the efficacy of suvorexant on LPS excluding the influence of a carryover effect from Period 1 to Period 2, an ad hoc analysis of LPS restricted to Period 1 data was also performed.|Night 1 (Period 1 only) and end of Week 4 (Period 1 only)|Full Analysis Set (FAS) population; subset of all randomized participants who received at least one dose of study medication and had any post-randomization efficacy assessment data. The FAS population may have varied across endpoints due to the degree of missing data for each endpoint.||minutes||Standard Error|Least Squares Mean
779556|NCT00792298|Secondary|LS Mean Latency to the Onset of Persistent Sleep (LPS) During Periods 1 and 2|LPS is defined as the duration of time measured in minutes from lights off to persistent sleep onset.|Night 1 and end of Week 4|Full Analysis Set (FAS) population; subset of all randomized participants who received at least one dose of study medication and had any post-randomization efficacy assessment data. The FAS population may have varied across endpoints due to the degree of missing data for each endpoint.||minutes||Standard Error|Least Squares Mean
779557|NCT00792298|Secondary|LS Mean Wake After Persistent Sleep Onset (WASO) During Periods 1 and 2|WASO was defined as the duration of wakefulness measured in minutes (any epoch of Stage 0) from persistent sleep onset (first epoch of the first twenty consecutive epochs of non-wake) to lights on.|Night 1 and end of Week 4|Full Analysis Set (FAS) population; subset of all randomized participants who received at least one dose of study medication and had any post-randomization efficacy assessment data. The FAS population may have varied across endpoints due to the degree of missing data for each endpoint.||minutes||Standard Error|Least Squares Mean
779558|NCT00792298|Primary|LS Mean Sleep Efficiency (SE) During Periods 1 and 2|SE was defined as total sleep time (TST) in minutes divided by time in bed (measured from lights off to lights on; fixed at 8 hours on each Polysomnography [PSG] night) in minutes, multiplied by 100, where TST is defined as the total time (minutes) in Stages 1, 2, 3, 4 and Rapid Eye Movement (REM). SE= (total sleep time/time in bed) x 100|Night 1 and end of Week 4|Full Analysis Set (FAS) population; subset of all randomized participants who received at least one dose of study medication and had any post-randomization efficacy assessment data. The FAS population may have varied across endpoints due to the degree of missing data for each endpoint.||percent of time in bed||Standard Error|Least Squares Mean
779559|NCT00792428|Secondary|Wolf-Motor-Function-Test|"The Wolf-Motor-Function-Test (time) is the average time in seconds taken to perform each of 15 functional tasks ranging in difficulty from putting one's forearm on a table to stacking checkers. Participants are given 120 seconds to perform a task and if they fail, they are scored 120 for that task, or similar as accurate. The average time in seconds is then log10 transformed."|Baseline Assessment; 3 days after 5 treatment days; 7 days after 5 treatment days|||units on a scale (log(sec))||Standard Deviation|Mean
779560|NCT00792428|Primary|Fugl-Meyer Assessment of Upper Extremity Motor Impairment|This scale goes from 0 to 66 (max). Higher values are considered to be a better outcome.|Baseline Assessment; 3 days after 5 treatment days; 7 days after 5 treatment days|||units on a scale [0-66]||Standard Deviation|Mean
779561|NCT00792610|Primary|Hepatitis B Surface Antibody Seroprotective Rate(Seroprotective: for Those Who Had Anti-HBs(Surface Antibody Against Hepatitis B) Titer Higher Than 10 mIU/mL)|The anti-HBs(Surface antibody against Hepatitis B) status was checked at baseline, 7-10 days, 1 month, 6 months, and 7 months following the first dose of hepatitis B vaccine. And then the seroprotective rate for anti-HBs(numbers of those who had anti-HBs titer higher than 10 mIU/mL/all participants numbers) was calculated respectively.|7 months|||participants|||Number
779562|NCT00792623|Secondary|Number of Subjects With Serious Adverse Events|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Over the active phase of the study (up to Month 24)|||Participants|||Count of Participants
779563|NCT00792623|Secondary|Occurrence of Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 43-day follow-up period after each vaccination|The analysis was performed on the Total vaccinated cohort, which included subjects with at least one vaccination administered, only on those with their symtpom sheets completed after the respective dose.||Participants|||Count of Participants
779564|NCT00792623|Secondary|Number of Subjects With Any and Related Rash|Rash was assessed as being either associated to the administration site or not. Non administration site rash was presented by following characteristics (with fever, measles/rubella like, varicella like and related).|During the 43-day follow-up period after each vaccination|The analysis was performed on the Total vaccinated cohort, which included subjects with at least one vaccination administered, only on those with their symtpom sheets completed after the respective dose.||Participants|||Count of Participants
779565|NCT00792623|Secondary|Number of Subjects With Any Fever|Any = fever equal to or greater than 37.5 °C. Grade 3 fever = fever > 39.0 °C. Related = assessed by the investigator as related to the vaccination.|During the 43-day follow-up period after each vaccination|The analysis was performed on the Total vaccinated cohort, which included subjects with at least one vaccination administered, only on those with their symtpom sheets completed after the respective dose.||Participants|||Count of Participants
779566|NCT00792623|Secondary|Number of Subjects With Any Solicited Local Adverse Events|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|During the 8-day follow-up period after each vaccination|The analysis was performed on the Total vaccinated cohort, which included subjects with at least one vaccination administered, only on those with their symtpom sheets completed after the respective dose.||Participants|||Count of Participants
779567|NCT00792623|Secondary|Anti-varicella Antibody Titers Above the Cut-off|Antibody titers were presented as geometric mean titers (GMTs)|At pre-transplantation (Month 0), pre-vaccination visit (4.5 Month post-transplantation), Month 5.5 and Month 7.5 post-vaccination|The analysis was performed on the initially seropositive subjects from the total vaccinated cohort, i.e those with anti-varicella antibody titer >=1:4 prior to vaccination and available results at pre-vaccination.||Titers||95% Confidence Interval|Geometric Mean
779568|NCT00792623|Secondary|Number of Subjects With Anti-varicella GMTs Avove the Cut-off|The cut-off titer was 1:4|At pre-transplantation (Month 0), pre-vaccination visit (4.5 Month post-transplantation), Month 5.5 and Month 7.5 post-vaccination|The analysis was performed on the initially seropositive subjects from the total vaccinated cohort, i.e those with anti-varicella antibody titer >=1:4 prior to vaccination and available results at pre-vaccination.||Participants|||Count of Participants
779569|NCT00792623|Secondary|Number of Subjects With a Vaccine Response|Vaccine response defined for initially seropositive subjects as having an antibody titer at 6.5 months post-transplantation >4 fold the pre-vaccination antibody titer|A 6.5 months post-transplantation = 2 months post first dose of vaccination|The analysis was performed on the initially seropositive subjects from the total vaccinated cohort, i.e those with anti-varicella antibody titer >=1:4 prior to vaccination and available results at pre- and post-vaccination.||Participants|||Count of Participants
779570|NCT00792623|Primary|Anti-varicella Antibody Titers|Antibody titers were presented as geometric mean titers (GMTs)|At 8 months post-transplantation = 1.5 months post second dose of vaccination|The analysis was performed on the initially seropositive subjects from the total vaccinated cohort, i.e those with anti-varicella antibody titer >=1:4 prior to vaccination and available results at pre-vaccination.||Titers||95% Confidence Interval|Geometric Mean
779571|NCT00792623|Primary|Number of Subjects With a Varicella Vaccine Response|Vaccine response defined for initially seropositive subjects as having an antibody titer at 8 months post-transplantation >4 fold the pre-vaccination antibody titer.|At 8 months post-transplantation = 1.5 months post second dose of vaccination|The analysis was performed on the initially seropositive subjects from the total vaccinated cohort, i.e those with anti-varicella antibody titer >=1:4 prior to vaccination and available results at pre-vaccination.||Participants|||Count of Participants
779572|NCT00792636|Secondary|Number of Participants Withdrawn From the Study Due to Blood Pressure Changes|The number of participants withdrawn from the study due to protocol-defined blood pressure changes were summarized for each treatment group. Defined blood pressure changes included (1) monthly average BP ≥140 mmHg systolic or >=90 mmHg diastolic and confirmed in clinic, (2) monthly average BP increase of >=30 mmHg systolic or >=20 mmHg from in-clinic screening and confirmed in clinic, and (3) systolic >=140 mmHg or diastolic >=90 mmHg on consecutive clinic visits >=2 weeks apart.|Baseline to End of Study (6-month study duration)|ITT Population||participants|||Number
779573|NCT00792636|Secondary|Time to the First Day With an Average Diastolic Blood Pressure Increase of >=3 mmHg From the Baseline Diastolic Blood Pressure|Kaplan-Meier curves for the distribution of time to the first day with an average diastolic BP increase of >=3 mmHg from the baseline diastolic BP during each calendar day were calculated and graphed for each treatment group. Only valid BP measurements were included and were defined as follows: must be taken at least 24 hours following last dose of investigational product used to treat an individual migraine, must be taken no later than 96 hours after last dose of investigational product used to treat an individual migraine, must be taken prior to the onset of a subsequent individual migraine.|Baseline to End of Study (6-month study duration)|ITT Population. Only participants with valid blood pressure measurements were analyzed.||days||Full Range|Median
779574|NCT00792636|Secondary|Time to the First Day With an Average Systolic Blood Pressure Increase of >=5 mmHg From the Baseline Systolic Blood Pressure|Kaplan-Meier curves for the distribution of time to the first day with an average diastolic BP increase of >=3 mmHg from the baseline diastolic BP during each calendar day were calculated and graphed for each treatment group. Only valid BP measurements were included and were defined as follows: must be taken at least 24 hours following last dose of investigational product used to treat an individual migraine, must be taken no later than 96 hours after last dose of investigational product used to treat an individual migraine, must be taken prior to the onset of a subsequent individual migraine.|Baseline to End of Study (6-month study duration)|ITT Population. Only participants with valid blood pressure measurements were analyzed.||days||Full Range|Median
779575|NCT00792636|Secondary|Number of Participants With a Consecutive 2-day Average Diastolic Blood Pressure of >=90 mmHg|The number of participants with any valid two-day consecutive average diastolic blood pressure measurement of >=90 mmHg was calculated. Valid blood pressure measurements were defined as follows: must be taken at least 24 hours following last dose of investigational product used to treat an individual migraine, must be taken no later than 96 hours after last dose of investigational product used to treat an individual migraine, must be taken prior to the onset of a subsequent individual migraine.|Baseline to End of Study (6-month study duration)|ITT Population||participants|||Number
779638|NCT00793403|Primary|Erythrocyte Sedimentation Rate (ESR) at Month 12|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.|Month 12|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||mm/hour||Standard Deviation|Mean
779576|NCT00792636|Secondary|Number of Participants With a Consecutive 2-day Average Systolic Blood Pressure of >=140 mmHg During the Study|The number of participants with any valid two-day consecutive average systolic blood pressure measurement of >=140 mmHg was calculated. Valid blood pressure measurements were defined as follows: must be taken at least 24 hours following last dose of investigational product used to treat an individual migraine, must be taken no later than 96 hours after last dose of investigational product used to treat an individual migraine, must be taken prior to the onset of a subsequent individual migraine.|Baseline to End of Study (6-month study duration)|ITT Population||participants|||Number
779577|NCT00792636|Secondary|Number of Participants With an Increase of >=3 mmHg From the Baseline Diastolic Blood Pressure for the Average of Any Given Two-day Consecutive Collection of Blood Pressure Measurements|The number of participants with an increase of >=3 mmHg from the baseline diastolic blood pressure for the average of any given two-day consecutive collection of valid blood pressure measurements during the study were summarized. Valid blood pressure measurements were defined as follows: must be taken at least 24 hours following last dose of investigational product used to treat an individual migraine, must be taken no later than 96 hours after last dose of investigational product used to treat an individual migraine, must be taken prior to the onset of a subsequent individual migraine.|Baseline to End of Study (6-month study duration)|ITT Population. Only participants with valid blood pressure measurements were analyzed.||participants|||Number
779578|NCT00792636|Secondary|Number of Participants With an Increase of >=5 mmHg From the Baseline Systolic Blood Pressure for the Average of Any Given Two-day Consecutive Collection of Blood Pressure Measurements|The number of participants with an increase of >=5 mmHg from the baseline systolic blood pressure for the average of any given two-day consecutive collection of valid blood pressure measurements during the study were summarized. Valid blood pressure measurements were defined as follows: must be taken at least 24 hours following last dose of investigational product used to treat an individual migraine, must be taken no later than 96 hours after last dose of investigational product used to treat an individual migraine, must be taken prior to the onset of a subsequent individual migraine.|Baseline to End of Study (6-month study duration)|ITT Population. Only participants with valid blood pressure measurements were analyzed.||participants|||Number
779579|NCT00792636|Secondary|Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen for the ITT Subpopulation of Participants Treating With <30 Total Doses, 30-60 Total Doses, >=30, 60-90 Total Doses, and >90 Total Doses|The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid T-SMBP measurements. The subgrouping of the ITT population was created and examined to demonstrate the robustness of the results for the primary analysis. Descriptive statistics were calculated for baseline, month 6, and change from baseline to month 6. LSMeans and corresponding confidence intervals (CIs) were based on MMRM analysis. LSMeans and CIs were not calculated for the 60-90 and the >90 total dose groups due to lack of convergence.|Baseline and Month 6|Intent-to-Treat (ITT) Population: all randomized participants who took at least one dose of investigational product and had at least one valid post-baseline at-home blood pressure assessment.||mmHg||95% Confidence Interval|Least Squares Mean
779580|NCT00792636|Secondary|Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen for the ITT Subpopulation of Participants Treating, on Average, With <6, 6-10, >=6, 10-14, and >14 Doses Per Month|The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid T-SMBP measurements. The subgrouping of the ITT population was created and examined to demonstrate the robustness of the results for the primary analysis. Descriptive statistics were calculated for baseline, month 6, and change from baseline to month 6. LSMeans and corresponding confidence intervals (CIs) were based on MMRM analysis. LSMeans and CIs were not calculated for the 10-14 and the >14 doses/month groups due to lack of convergence.|Baseline and Month 6|Intent-to-Treat (ITT) Population: all randomized participants who took at least one dose of investigational product and had at least one valid post-baseline at-home blood pressure assessment.||mmHg||95% Confidence Interval|Least Squares Mean
779581|NCT00792636|Secondary|Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen for the ITT Subpopulation of Participants Treating, on Average, <1.3 Times Per Migraine, 1.3-1.7 Times Per Migraine, and >1.7 Times Per Migraine|The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid T-SMBP measurements. The subgrouping of the ITT population was created and examined to demonstrate the robustness of the results for the primary analysis.Descriptive statistics were calculated for baseline, month 6, and change from baseline to month 6. LSMeans and corresponding confidence intervals were based on MMRM analysis.|Baseline and Month 6|Intent-to-Treat (ITT) Population: all randomized participants who took at least one dose of investigational product and had at least one valid post-baseline at-home blood pressure assessment.||mmHg||95% Confidence Interval|Least Squares Mean
779582|NCT00792636|Secondary|Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen for the ITT Subpopulation of Participants Treating, on Average, <4 Migraines, 4-6 Migraines, >=4 Migraines, and >6 Migraines Per Month|The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid T-SMBP measurements. The subgrouping of the ITT population was created and examined to demonstrate the robustness of the results for the primary analysis.Descriptive statistics were calculated for baseline, month 6, and change from baseline to month 6. LSMeans and corresponding confidence intervals were based on MMRM analysis. LSMeans and corresponding confidence intervals were not calculated for > 6 migraines/month group due to lack of convergence.|Baseline and Month 6|Intent-to-Treat (ITT) Population: all randomized participants who took at least one dose of investigational product and had at least one valid post-baseline at-home blood pressure assessment.||mmHg||95% Confidence Interval|Least Squares Mean
779597|NCT00792922|Primary|Community Prevalence of Trachoma and Ocular C. Trachomatis (CT) Infection at 36 Months|"100 random sentinel children aged 0- 5 years per community were to be examined for prevalence of trachoma & CT infection in Tanzania & Gambia.
50-100 random sentinel children aged 0-5 years per community were to be examined in Niger per community for prevalence of TF and CT infection.
Outcomes are reported at the community level because raw data could not be accessed.
There is no way to determine how many participants were examined in each arm."|3 years|We analyzed and reported the results of the trial at community level.||community|community|Standard Deviation|Mean
779583|NCT00792636|Secondary|Treatment Difference in Systolic and Diastolic Blood Pressure Mean Changes From Baseline at 6 Months Between Sumatriptan/Naproxen and Naproxen|The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid Telephonic Self-Measured Blood Pressure (T-SMBP) measurements. T-SMBP technology is a method that allows the participant to self-measure BP outside the clinic using a BP monitor and transfer the data from their home to a central server. Change from baseline was calculated as the Month 6 value minus the Baseline value. Least squares mean and confidence intervals were based on mixed model repeated measures analysis (MMRM).|Baseline and Month 6|ITT Population. Mean BP values were not available for all participants at baseline and Month 6 due to participant drop-out or to an inadequate number of BP collections.||mmHg||Standard Deviation|Mean
779584|NCT00792636|Secondary|Treatment Difference in Systolic and Diastolic Blood Pressure Mean Changes From Baseline at 6 Months Between Sumatriptan/Naproxen and Sumatriptan|The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid Telephonic Self-Measured Blood Pressure (T-SMBP) measurements. T-SMBP technology is a method that allows the participant to self-measure BP outside the clinic using a BP monitor and transfer the data from their home to a central server. Change from baseline was calculated as the Month 6 value minus the Baseline value. Least squares mean and confidence intervals were based on mixed model repeated measures analysis (MMRM).|Baseline and Month 6|ITT Population. Mean BP values were not available for all participants at baseline and Month 6 due to participant drop-out or to an inadequate number of BP collections.||mmHg||Standard Error|Mean
779585|NCT00792636|Primary|Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen|The calculation of baseline and post-baseline mean blood pressure (BP) (either systolic or diastolic) for each month (30-day period) is the average of all valid Telephonic Self-Measured Blood Pressure (T-SMBP) measurements. T-SMBP technology is a method that allows the participant to self-measure BP outside the clinic using a BP monitor and transfer the data from their home to a central server. Change from baseline was calculated as the Month 6 value minus the Baseline value. Least squares mean and confidence intervals were based on mixed model repeated measures analysis (MMRM).|Baseline and Month 6|Intent-to-Treat (ITT) Population: all randomized participants who took at least one dose of investigational product and had at least one valid post-baseline at-home BP assessment. Mean BP values were not available for all participants at baseline and Month 6 due to participant drop-out or to an inadequate number of BP collections.||millimeters of mercury (mmHg)||Standard Deviation|Mean
779586|NCT00792636|Secondary|Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan and Naproxen|The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid Telephonic Self-Measured Blood Pressure (T-SMBP) measurements. T-SMBP technology is a method that allows the participant to self-measure BP outside the clinic using a BP monitor and transfer the data from their home to a central server. Change from baseline was calculated as the Month 6 value minus the Baseline value. Least squares mean and confidence intervals were based on mixed model repeated measures analysis (MMRM).|Baseline and Month 6|ITT Population. Mean BP values were not available for all participants at baseline and Month 6 due to participant drop-out or to an inadequate number of BP collections.||mmHg||Standard Deviation|Mean
779587|NCT00792688|Secondary|Cosmesis/11-point Likert Scale|The cosmetic effect on each lower eyelid using an 11-point Likert Scale (0 = not healed and 10 = healed).|At 1 month following the initial treatment.|||scores on a scale||Standard Deviation|Mean
779588|NCT00792688|Primary|Time to Complete Wound Closure (Epithelialization)|Subjects were evaluated daily from the time of the laser procedure and initial application of test article until the subject’s wounds reached 100% epithelialization. Efficacy was assessed based on the time to complete epithelialization in terms of the number of days from Day 1 (day of laser ablation) to the day on which complete epithelialization was observed.|Over the course of 1 month following the initial treatment.|Analysis was Per Protocol.||days||Standard Deviation|Mean
779589|NCT00792701|Other Pre-specified|Relationship Between RNA and Protein Expression of RRM1 and ERCC1||From time of registration to maximum of 2 years|||Scores||Full Range|Median
779590|NCT00792701|Other Pre-specified|Generation of Results on in Situ Protein Expression and Other Assays for Genes Involved in Drug Efficacy||From time of registration to maximum of 2 years|Due to lack of funding, the protein expression data were never collected. Thus, this outcome could not be analyzed.|||||
779591|NCT00792701|Other Pre-specified|Analytical Performance of the Biomarker Assay||From time of registration to maximum of 2 years|Due to lack of funding, the assay was never performed. Thus, this outcome could not be analyzed.|||||
779592|NCT00792701|Secondary|Relationship Between RRM1 and ERCC1 Expression in the Formalin-fixed and Paraffin-embedded Tumor Specimens.|RRM1 and ERCC1 protein levels are expressed as a simple score with no units.|From time of registration to maximum of 2 years|Protein expression relationships were analyzed in the overall patient population, and not by arm.||Scores||Full Range|Median
779593|NCT00792701|Secondary|Frequency and Severity of Toxicities as Assessed by NCI CTCAE v3.0|Patients in the active monitoring arm were not followed for adverse events.|From time of registration to maximum of 2 years|"Number of Subjects With Greater Than Grade 2 Toxicity
Patients in the active monitoring arm were not followed for adverse events."||participants|||Number
779594|NCT00792701|Secondary|Two-year Disease-free Survival||From time of registration to maximum of 2 years|||percentage of participants||95% Confidence Interval|Number
779595|NCT00792701|Primary|Feasibility of Pharmacogenomics-based Treatment Assignment in the Cooperative Group Setting|Feasibility will be assessed both by accrual rate and the percentage of patients successfully assigned to adjuvant chemotherapy or active monitoring.|From time of registration to 84 days after surgical resection.|Percentage of patients successfully assigned to adjuvant chemotherapy or active monitoring.||Participants|||Count of Participants
779596|NCT00792805|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 + 1 Day, Day 85|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1 and FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening as covariates.|Week 12 + 1 day, Day 85|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Last observation carried forward (LOCF) was utilized to impute missing data.||Liters||Standard Error|Least Squares Mean
779598|NCT00792922|Primary|Community Prevalence of Trachoma and Ocular C. Trachomatis (CT) Infection at Baseline|"Mass drug administration (MDA) with azithromycin or topical tetracycline is recommended by World Health Organization (WHO) for 3 years in districts where the prevalence of trachoma is>=10 % in children aged 1-9 years.
The prevalence of trachoma (TF) was measured using the Simplified WHO Grading System. Both eyelids were everted and tarsal conjunctiva graded for signs of clinical trachoma. Ocular photographs of right eye were taken on random samples of sentinel children to determine the drift in grading over time. To detect CT infection, an ocular swab of the right eye using a Dacron swab was collected from the sentinel kids. The swab was stored dry, and frozen until shipped and processed in the laboratory. Air control swabs were also taken to test for field and laboratory contamination."|At baseline|"At baseline 8 communities were randomized to each arm in Tanzania, 12 communities were randomized to each arm in Gambia and Niger.
Stop rule could not be applied in Tanzania.Communities in stop arm were moved to ≥90% coverage or 80%-89% coverage with azithromycin target arm and only main effect of coverage was analyzed in Tanzania."||community|community|Standard Deviation|Mean
779599|NCT00792935|Primary|Number of Participants Who Experienced One or More Episodes of Hypoglycemia (Symptomatic or Asymptomatic)|"Hypoglycemic episodes are defined as either a fingerstick glucose
measurement of ≤70 mg/dL [3.9 mmol/L] with or without symptoms or symptomatic hypoglycemia."|Baseline to Week 6|All patients as treated (APaT) defined as all randomized participants who received at least one dose of MK-0941 or glimepiride.||participants|||Number
779600|NCT00792935|Primary|Change From Baseline to Week 6 in 24-hour Weighted Mean Glucose|"Weighted Mean Glucose (WMG) is a measure of the amount of glucose in the blood over a period of 24 hours. The WMG was derived from multiple glucose values collected during both fasting and post-meal periods. The weighted mean was used to avoid over-representation of post-meal glucose values."|Baseline and Week 6|The full analysis set (FAS) population included all randomized participants who had efficacy measurements at baseline or a post-randomization visit).||mg/dL||95% Confidence Interval|Least Squares Mean
779601|NCT00792948|Other Pre-specified|MRD as Assessed Using Real-time Quantitative Polymerase Chain Reaction and Flow Cytometry|Correlation between the two measures of MRD measured on the same remission specimens will be examined using scatterplots and correlation analysis. The prognostic effect for relapse of each measure will be illustrated using cumulative incidence plots, and estimated using Cox regression models. This outcome will be reported as funding allows.|Up to 5 years||||||
779602|NCT00792948|Other Pre-specified|Overall Survival (OS)|OS will be estimated using the method of Kaplan-Meier.|From the date of initial registration on the study until death from any cause, assessed up to 5 years|Analysis includes eligible patients who received treatment.||Probability of surviving 12 months||95% Confidence Interval|Number
779603|NCT00792948|Secondary|Continuous Complete Remission (CCR) Rate|Will be testing using an exact binomial test|18 months|Patients who had not received prior ALL therapy||percentage of participants||95% Confidence Interval|Number
779604|NCT00792948|Primary|Relapse-free Survival (RFS) After Allogeneic Stem Cell Transplantation|Will be estimated using the method of Kaplan-Meier.|12 months|Patients who received allogeneic stem cell transplant||Probability of 12-month RFS||95% Confidence Interval|Number
779605|NCT00793104|Secondary|MRI Evaluation Score|MRI images were graded by a radiologist with regard to the incorporation of the CR graft in both the cancellous and cortical portions of the bone at the graft site. The raw scores were converted to an index scale form 0 to 100, with 0 representing failure of the graft to incorporate and 100 representing complete incorporation of the graft.|24 months|||units on a scale||Standard Deviation|Mean
779606|NCT00793104|Secondary|International Knee Documentation Committee (IKDC) at 24 Months.|The International Knee Documentation Committee scores are transformed to a 0–100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.|24 months|||units on a scale||Standard Deviation|Mean
779607|NCT00793104|Secondary|Lysholm With Tegner Score|The Tegner activity scale was designed as a score of activity level to complement other functional scores (eg the Lysholm knee score) for patients with ligamentous injuries. The instrument scores a person's activity level between 0 and 100 where 0 is 'on sick leave/disability' and 100 is 'participation in competitive sports at a full, unhindered level.|24 months|||units on a scale||Standard Deviation|Mean
779608|NCT00793104|Secondary|Current Health Assessment|Evaluation on the Current Health Assessment at 24 months. Scores are transformed to a 0–100 scale, with zero representing a self-graded perception of extremely poor health and 100 representing no health problems. Scores between 0 and 100 represent the percentage of total possible score achieved.|24 months, MRI only at 12 and 24 months|||units on a scale||Standard Deviation|Mean
779609|NCT00793104|Primary|The Knee Injury and Osteoarthritis Outcome Score (KOOS) at 24 Months|The outcome at 24 months as measured by the Knee injury and Osteoarthritis Outcome Score (KOOS). Scores are transformed to a 0–100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.|24 months|||units on a scale||Standard Deviation|Mean
779610|NCT00793169|Primary|The Number of Subjects With Detectable Serum Lidocaine Concentrations (<0.1 ug/mL) at Each Blood Draw.||6 hours|Analysis was per protocol.||Participants|||Number
779611|NCT00793182|Primary|Evaluate the Incidence of Contrast-induced Nephropathy (CIN), Defined as an Increase of ≥ 25% or an Increase of ≥ 0.5 mg/dL From Baseline Serum Creatinine (SCr), Within 48 - 72 Hours After Contrast Administration.||Labs obtained 2-24 hours before and 48-72 hours after contrast administration, with a 7-day follow-up if indicated|There were no subjects with a postcontrast Scr measurement reflecting an increase of ≥25% or ≥0.5 mg/dL from baseline, so no additional blood samples were obtained at 7days (±24 hours) postcontrast. Data were not collected|||||
779612|NCT00793325|Primary|Change in Height SD Score for Calendar Age.|The change in height standard SD for calendar age = (Height SD score for each calendar age - Height SD score for calendar age of the previous year) / (the date on which the height was measured - the date of the previous year on which the height was measured) × 365.25.|Up to 3 years|The efficacy analysis population basically consists of the evaluable participants in whom the changes in the growth rate SD score for calendar age and in the height SD score for calendar age were assessed.||standard deviation (SD) score||Standard Deviation|Mean
779613|NCT00793325|Primary|Change in the Growth Rate Standard Deviation (SD) Score for Calendar Age.|Growth rate SD score = (Growth rate - Average growth rate for calendar age of gender) / SD score for growth rate for each calendar age of gender). An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. In addition, when the bone age was described, it was to be read as the calendar age for men who were 11 years or older and women who were 9 years or older, as necessary.|Up to 3 years|The efficacy analysis population basically consists of the evaluable participants in whom the changes in the growth rate SD score for calendar age and in the height SD score for calendar age were assessed.||standard deviation (SD) score||Standard Deviation|Mean
779614|NCT00793325|Primary|Number of Participants With Treatment Related Adverse Events of Somatropin: With Concomitant Drug(s) vs. Without Concomitant Drug(s).|To determine whether taking concomitant drug(s) is a significant risk factor in the frequency of treatment related adverse events.|Up to 3 years|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.||Participants|||Number
779615|NCT00793325|Primary|Number of Participants With Treatment Related Adverse Events of Somatropin: With Renal Impairment vs. Without Renal Impairment.|To determine whether renal impairment is a significant risk factor in the frequency of treatment related adverse events.|Up to 3 years|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.||Participants|||Number
779616|NCT00793325|Primary|Number of Participants With Treatment Related Adverse Events of Somatropin: With Hepatic Function Disorder vs. Without Hepatic Function Disorder.|To determine whether hepatic function disorder is a significant risk factor in the frequency of treatment related adverse events.|Up to 3 years|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.||Participants|||Number
779617|NCT00793325|Primary|Number of Participants With Treatment Related Adverse Events of Somatropin: With Complications vs. Without Complications|To determine whether having complication(s) is a significant risk factor in the frequency of treatment related adverse events.|Up to 3 years|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.||participants|||Number
779618|NCT00793325|Primary|Number of Participants With Treatment Related Adverse Events of Somatropin: With Past History of Any Disease vs. Without Past History of Any Disease.|To determine whether past history of any disease is a significant risk factor in the frequency of treatment related adverse events.|Up to 3 years|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.||participants|||Number
779619|NCT00793325|Primary|Number of Participants With Treatment Related Adverse Events of Somatropin Based on SGA Severity.|To determine whether severity of SGA is a significant risk factor in the frequency of treatment related adverse events. The severity of SGA was comprehensively evaluated on the basis of information including height and weight at birth and height measured one year before the start of administration.|Up to 3 years|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.||participants|||Number
779620|NCT00793325|Primary|Number of Participants With Treatment Related Adverse Events of Somatropin by Gender.|To determine whether gender is a significant risk factor in the frequency of treatment related adverse events.|Up to 3 years|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.||participants|||Number
779621|NCT00793325|Primary|Number of Participants With Treatment Related Adverse Events of Somatropin: <15 Years of Age vs. >=15 Years of Age.|To determine whether age is a significant risk factor in the frequency of treatment related adverse events.|Up to 3 years|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.||participants|||Number
779622|NCT00793325|Primary|Number of Unlisted Treatment Related Adverse Events According to Japanese Package Insert.|Adverse events mean all unfavorable events that occur in participants after administration of somatropin, irrespective of causal relationship to somatropin (including clinically problematic abnormal changes in laboratory test values). Treatment related adverse events were evaluated in company with the causal relationship to somatropin. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction according to Japanese package insert.|Up to 3 years|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.||events|||Number
779623|NCT00793325|Primary|Number of Participants With Treatment Related Adverse Events.|Adverse events mean all unfavorable events that occur in participants after administration of somatropin, irrespective of causal relationship to somatropin (including clinically problematic abnormal changes in laboratory test values). Treatment related adverse events were evaluated in company with the causal relationship to somatropin.|Up to 3 years|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.||participants|||Number
779624|NCT00793403|Primary|Radiological Assessment of Hands and Feet Based on Sharp-Van Der Hejde (SvH) Scoring Method at Month 12|SvH method included 16 areas for erosions and 15 areas for JSN and subluxation/luxation in each hand, 6 areas for erosions and 6 areas for JSN and subluxation/luxation in each foot. Erosion per joint scored on 0-5 point scale; 0=normal joint to 5=complete collapse. Total erosion score for hands:0-160, for feet:0-120. JSN and subluxation/luxation scored on 0-4 point scale; 0=normal joint to 4= a bony ankylosis/a complete luxation of joint. Total JSN and subluxation/luxation score for hands:0-120, for feet:0-48. Total SvH score = 0-448; higher score=more erosion and JSN.|Month 12|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.|||||
779637|NCT00793403|Primary|Number of Participants With Rheumatoid Factor (RF) at Month 6|RF is the auto antibody directed against immunoglobulin G (IgG) and its concentration is observed in human serum or plasma. RF value higher than 20 units per milliliter (U/mL) is considered positive.|Month 6|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.|||||
779625|NCT00793403|Primary|Radiological Assessment of Hands and Feet Based on Sharp-van Der Hejde (SvH) Scoring Method at Month 6|SvH method included 16 areas for erosions and 15 areas for joint space narrowing (JSN) and subluxation/luxation in each hand, 6 areas for erosions and 6 areas for JSN and subluxation/luxation in each foot. Erosion per joint scored on 0-5 point scale; 0=normal joint to 5=complete collapse. Total erosion score for hands:0-160, for feet:0-120. JSN and subluxation/luxation scored on 0-4 point scale; 0=normal joint to 4= a bony ankylosis/a complete luxation of joint. Total JSN and subluxation/luxation score for hands:0-120, for feet:0-48. Total SvH score = 0-448; higher score=more erosion and JSN.|Month 6|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.|||||
779626|NCT00793403|Primary|Recent-Onset Arthritis Disability (ROAD) at Month 12|ROAD questionnaire: valid and responsive tool for measuring functional ability in RA participants. Consists of 12-items related to fine movements of upper extremity, locomotor activities of lower extremity, and activities that involve both upper and lower extremities. For each item participant rated the level of difficulty over the past week on a 5-point scale ranging from 0 (without any difficulty) to 4 (unable to do). Total ROAD score were transformed to a 0 to 10 point scale, where 0 = best status and 10 = poorest status.|Month 12|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||Units on a scale||Standard Deviation|Mean
779627|NCT00793403|Primary|Recent-Onset Arthritis Disability (ROAD) at Month 6|ROAD questionnaire: valid and responsive tool for measuring functional ability in RA participants. Consists of 12-items related to fine movements of upper extremity, locomotor activities of lower extremity, and activities that involve both upper and lower extremities. For each item participant rated the level of difficulty over the past week on a 5-point scale ranging from 0 (without any difficulty) to 4 (unable to do). Total ROAD score were transformed to a 0 to 10 point scale, where 0 = best status and 10 = poorest status.|Month 6|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||Units on a scale||Standard Deviation|Mean
779628|NCT00793403|Primary|Health Assessment Questionnaire (HAQ) at Month 12|HAQ: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Month 12|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||Units on a scale||Standard Deviation|Mean
779629|NCT00793403|Primary|Health Assessment Questionnaire (HAQ) at Month 6|HAQ: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Month 6|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||Units on a scale||Standard Deviation|Mean
779630|NCT00793403|Primary|Duration of Morning Stiffness at Month 12|Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Month 12|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.|||||
779631|NCT00793403|Primary|Duration of Morning Stiffness at Month 6|Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Month 6|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.|||||
779632|NCT00793403|Primary|Patient Assessment of Arthritis Pain at Month 12|Participants rated the severity of arthritis pain on a 0 to 10 cm VAS, where 0 cm = no pain and 10 cm = most severe pain.|Month 12|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||cm||Standard Deviation|Mean
779633|NCT00793403|Primary|Patient Assessment of Arthritis Pain at Month 6|Participants rated the severity of arthritis pain on a 0 to 10 cm VAS, where 0 cm = no pain and 10 cm = most severe pain.|Month 6|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||cm||Standard Deviation|Mean
779634|NCT00793403|Primary|Patient’s General Health Assessment at Month 12|"Participants answered: How would you describe your general health today? Participants assessed their general health using a 0 - 10 cm VAS, where 0 cm = very well and 10 cm = very poor."|Month 12|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.|||||
779635|NCT00793403|Primary|Patient’s General Health Assessment at Month 6|"Participants answered: How would you describe your general health today? Participants assessed their general health using a 0 - 10 cm VAS, where 0 cm = very well and 10 cm = very poor."|Month 6|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.|||||
779636|NCT00793403|Primary|Number of Participants With Rheumatoid Factor (RF) at Month 12|RF is the auto antibody directed against immunoglobulin G (IgG) and its concentration is observed in human serum or plasma. RF value higher than 20 U/mL is considered positive.|Month 12|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.|||||
793604|NCT00907374|Secondary|Estimated Glomerular Filtration Rate|This is an average for all participants during the 3-36 month study period|3 to 36 months|Completers||ml/min/1.73 meters squared||Standard Deviation|Mean
779639|NCT00793403|Primary|Erythrocyte Sedimentation Rate (ESR) at Month 6|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.|Month 6|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||mm/hr||Standard Deviation|Mean
779640|NCT00793403|Primary|C-reactive Protein (CRP) at Month 12|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is <1 mg/dL. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Month 12|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||mg/dL||Standard Deviation|Mean
779641|NCT00793403|Primary|C-reactive Protein (CRP) at Month 6|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is <1 mg/dL. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Month 6|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||mg/dL||Standard Deviation|Mean
779642|NCT00793403|Primary|Visual Analog Fatigue Scale (VAFS) at Month 12|Participants assessed their fatigue using a 0 - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue.|Month 12|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.|||||
779643|NCT00793403|Primary|Visual Analog Fatigue Scale (VAFS) at Month 6|Participants assessed their fatigue using a 0 - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue.|Month 6|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.|||||
779644|NCT00793403|Primary|Physician Global Assessment (PGA) of Disease Activity at Month 12|Physician Global Assessment of Arthritis was measured on a 0 to 10 cm VAS, where 0 cm = very good and 10 cm = very bad.|Month 12|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||cm||Standard Deviation|Mean
779645|NCT00793403|Primary|Physician Global Assessment (PGA) of Disease Activity at Month 6|Physician Global Assessment of Arthritis was measured on a 0 to 10 cm VAS, where 0 cm = very good and 10 cm = very bad.|Month 6|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||cm||Standard Deviation|Mean
779646|NCT00793403|Primary|Patient Global Assessment (PtGA) of Disease Activity at Month 12|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 10 cm VAS, where 0 cm = very well and 10 cm = very poorly."|Month 12|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||cm||Standard Deviation|Mean
779647|NCT00793403|Primary|Patient Global Assessment (PtGA) of Disease Activity at Month 6|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 10 cm VAS, where 0 cm = very well and 10 cm = very poorly."|Month 6|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||cm||Standard Deviation|Mean
779648|NCT00793403|Primary|Clinical Arthritis Activity (CLARA) Index at Month 12|CLARA: index of RA activity. Consists of 3-items: participant’s physical function (12 questions each scored on a 0 [without any difficulty] to 4 [unable to do] point scale); TJC (based on 16-joints, tenderness assessed on 0 [none] to 3 [severe] point scale); SJC (based on 28-joints). Each item was transformed on a 0-10 point scale, higher scores=more disease activity. CLARA total score=sum of scores of all 3 items divided by 3, range= 0-10, higher scores=more disease activity.|Month 12|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||Units on a scale||Standard Deviation|Mean
779649|NCT00793403|Primary|Clinical Arthritis Activity (CLARA) Index at Month 6|CLARA: index of RA activity. Consists of 3-items: participant’s physical function (12 questions each scored on a 0 [without any difficulty] to 4 [unable to do] point scale); TJC (based on 16-joints, tenderness assessed on 0 [none] to 3 [severe] point scale); SJC (based on 28-joints). Each item was transformed on a 0-10 point scale, higher scores=more disease activity. CLARA total score=sum of scores of all 3 items divided by 3, range= 0-10, higher scores=more disease activity.|Month 6|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||Units on a scale||Standard Deviation|Mean
779650|NCT00793403|Primary|Patient Reported Outcomes - Clinical Arthritis Activity (PRO-CLARA ) at Month 12|PRO-CLARA:self-administered index of RA activity. Consists of 3-items: participant’s physical function (12 questions each scored on a 0 [without any difficulty] to 4 [unable to do] point scale); TJC(based on 16-joints, tenderness assessed on 0 [none] to 3 [severe] point scale); PtGA (participant rated disease activity on 0-10 cm VAS, 0=very well, 10 cm=very poorly). Participant’s physical function and TJC were transformed on a 0-10 point scale, higher scores=more disease activity. PRO-CLARA total score=sum of scores of all 3 items divided by 3, range= 0-10, higher scores=more disease activity.|Month 12|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.|||||
779651|NCT00793403|Primary|Patient Reported Outcomes - Clinical Arthritis Activity (PRO-CLARA ) at Month 6|PRO-CLARA:self-administered index of RA activity. Consists of 3-items: participant’s physical function (12 questions each scored on a 0 [without any difficulty] to 4 [unable to do] point scale); TJC(based on 16-joints, tenderness assessed on 0 [none] to 3 [severe] point scale); PtGA (participant rated disease activity on 0-10 cm VAS, 0=very well, 10 cm=very poorly). Participant’s physical function and TJC were transformed on a 0-10 point scale, higher scores=more disease activity. PRO-CLARA total score=sum of scores of all 3 items divided by 3, range= 0-10, higher scores=more disease activity.|Month 6|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.|||||
779652|NCT00793403|Primary|Clinical Disease Activity Index (CDAI) at Month 12|The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PGA (assessed on 0-10 cm VAS; higher scores=greater affection due to disease activity). CDAI total score = 0-76. CDAI <= 2.8 indicates disease remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high disease activity.|Month 12|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.|||||
779653|NCT00793403|Primary|Clinical Disease Activity Index (CDAI) at Month 6|The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PGA (assessed on 0-10 cm VAS; higher scores=greater affection due to disease activity). CDAI total score = 0-76. CDAI <= 2.8 indicates disease remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high disease activity.|Month 6|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.|||||
779654|NCT00793403|Primary|Rheumatoid Arthritis Disease Activity Index (RADAI) at Month 12|RADAI:self-assessed measure of disease activity in RA. Consists of 5 items: GDA in past 6 months; CDA as measured by SJC and TJC; current arthritis pain; current duration of morning stiffness; current TJC. GDA,CDA and pain were scored on an 11-point numerical rating scale,0=no disease activity/pain to 10=extreme disease activity/pain. Current morning stiffness and TJC were transformed to a 0-10 point scale,higher scores=more disease activity. RADAI total score=sum of individual items divided by 5;range 0-10, higher score=more disease activity.|Month 12|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||Units on a scale||Standard Deviation|Mean
779655|NCT00793403|Primary|Rheumatoid Arthritis Disease Activity Index (RADAI) at Month 6|RADAI:self-assessed measure of disease activity in RA. Consists of 5 items: global disease activity(GDA) in past 6 months; current disease activity(CDA) as measured by SJC and TJC; current arthritis pain; current duration of morning stiffness; current TJC. GDA,CDA and pain were scored on an 11-point numerical rating scale,0=no disease activity/pain to 10=extreme disease activity/pain. Current morning stiffness and TJC were transformed to a 0-10 point scale,higher scores=more disease activity. RADAI total score=sum of individual items divided by 5;range 0-10, higher score=more disease activity.|Month 6|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||Units on a scale||Standard Deviation|Mean
779656|NCT00793403|Primary|Simplified Disease Activity Index (SDAI) at Month 12|The SDAI is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PGA (assessed on 0-10 cm VAS; higher scores=greater affection due to disease activity), and CRP (mg/dL). SDAI total score= 0-86. SDAI <=3.3 indicates disease remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity.|Month 12|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.|||||
779657|NCT00793403|Primary|Simplified Disease Activity Index (SDAI) at Month 6|The SDAI is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PGA (assessed on 0-10 cm VAS; higher scores=greater affection due to disease activity), and CRP (mg/dL). SDAI total score= 0-86. SDAI <=3.3 indicates disease remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity.|Month 6|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.|||||
779658|NCT00793403|Primary|Disease Activity Score Based on 28-joints Count (DAS28) at Month 12|DAS28 calculated from SJC and TJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10 cm VAS; higher scores indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28 <= 3.2 implied low disease activity and > 3.2 to 5.1 implied moderate to high disease activity, and DAS28 < 2.6 = remission.|Month 12|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.|||||
779659|NCT00793403|Primary|Disease Activity Score Based on 28-joints Count (DAS28) at Month 6|DAS28 calculated from SJC and TJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10 cm VAS; higher scores indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28 <= 3.2 implied low disease activity and > 3.2 to 5.1 implied moderate to high disease activity, and DAS28 < 2.6 = remission.|Month 6|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.|||||
779660|NCT00793403|Primary|Number of Swollen Joints (SJC) and Tender Joints (TJC) at Month 12|"Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1.
Number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1."|Month 12|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||Joints||Standard Deviation|Mean
779661|NCT00793403|Primary|Number of Swollen Joints (SJC) and Tender Joints (TJC) at Month 6|"Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1.
Number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1."|Month 6|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||Joints||Standard Deviation|Mean
779673|NCT00793546|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 hour (pre-dose) on Day 1, 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 29|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.|||||
779662|NCT00793403|Primary|Minimal Disease Activity: Italian Group for the Study of Early Arthritis (GISEA) at Month 12|GISEA minimal disease activity criteria: a participant was considered with minimal disease activity if he/she met the following criteria: SJC <=2 (based on 28-joints); HAQ <=0.5 (assessment of ability to perform task on 0-3 point scale, 0=least difficulty and 3=extreme difficulty); and ESR <=20 mm/hr.|Month 12|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.|||||
779663|NCT00793403|Primary|Minimal Disease Activity: Italian Group for the Study of Early Arthritis (GISEA) at Month 6|GISEA minimal disease activity criteria: a participant was considered with minimal disease activity if he/she met the following criteria: SJC <=2 (based on 28-joints); HAQ <=0.5 (assessment of ability to perform task on 0-3 point scale, 0=least difficulty and 3=extreme difficulty); and ESR <=20 mm/hr.|Month 6|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.|||||
779664|NCT00793403|Primary|Minimal Disease Activity: Outcome Measures in Rheumatology Arthritis Clinical Trials (OMERACT) at Month 12|OMERACT minimal disease activity: participant considered with minimal disease activity if he/she met 5 of 7 criteria: Pain <=2 (assessed on a 0-10 cm VAS, 0 cm=no pain and 10 cm=worst possible pain); SJC <=1; TJC <=1 (SJC, TJC based on 28-joints); HAQ <=0.5 (assessment of ability to perform task on 0-3 point scale, 0=least difficulty and 3=extreme difficulty); PGA <=1.5; PtGA <=2 (PGA, PtGA: assessed on 0-10 cm VAS, higher score = greater affection due to disease activity); ESR <=20 mm/hr.|Month 12|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.|||||
779665|NCT00793403|Primary|Minimal Disease Activity: Outcome Measures in Rheumatology Arthritis Clinical Trials (OMERACT) at Month 6|OMERACT minimal disease activity: participant considered with minimal disease activity if he/she met 5 of 7 criteria: Pain <=2 (assessed on a 0-10 cm VAS, 0 cm=no pain and 10 cm=worst possible pain); SJC <=1; TJC <=1 (SJC, TJC based on 28-joints); Health Assessment Questionnaire (HAQ) <=0.5 (assessment of ability to perform task on 0-3 point scale, 0=least difficulty and 3=extreme difficulty); PGA <=1.5; PtGA <=2 (PGA, PtGA: assessed on 0-10 cm VAS, higher score = greater affection due to disease activity); erythrocyte sedimentation rate (ESR) <=20 millimeter per hour (mm/hr).|Month 6|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.|||||
779666|NCT00793403|Primary|Percentage of Participants With Remission as Per Modified American College of Rheumatology (Modified ACR) Criteria at Month 12|Modified ACR: participant was considered in RA remission if at any time point 1) participant satisfied all of the following criteria: TJC <=1; SJC <=1 (TJC, SJC based on 28-joints); CRP <=1 mg/dL; PtGA<=1 (assessed on 0-10 centimeter[cm] visual analog scale[VAS]) or 2) participant had SDAI score of <=3.3 (SDAI: the numerical sum of 5 outcome parameters: TJC, SJC, PtGA, PGA [assessed on 0-10 cm VAS], and CRP [mg/dL]).|Month 12|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.|||||
779667|NCT00793403|Primary|Percentage of Participants With Remission as Per Modified American College of Rheumatology (Modified ACR) Criteria at Month 6|Modified ACR: participant considered in RA remission if at any time point 1) participant satisfied all of the following criteria: tender joint count(TJC) less than or equal to(<=)1;swollen joint count(SJC)<=1 (TJC, SJC based on 28-joints);C-reactive protein(CRP)<=1 milligram/deciliter(mg/dL); patient global assessment (PtGA) <=1 (assessed on 0-10 centimeter[cm] visual analog scale[VAS]) or 2) participant had Simplified Disease Activity Index score of <=3.3 (SDAI, numerical sum of 5 outcome parameters: TJC, SJC, PtGA, physician global assessment [PGA, assessed on 0-10 cm VAS], and CRP [mg/dL]).|Month 6|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.|||||
779668|NCT00793455|Secondary|Colorectal Cancer Screening Completion|"We reviewed electronic health records of participants 6 months post randomization to ascertain outcome. We looked for one or both of the following (1) note in free text MD note documenting receipt of one form of colorectal cancer (CRC) screening during study period (2)lab results from fecal occult blood test, sigmoidoscopy, or colonoscopy.
Participants were categorized as completing CRC screening if there was a lab result or physician note located in chart during study period. If no note or lab result was found in chart, then the participant was categorized as not completing CRC screening."|6 months post randomization|Analysis was based on intention to treat.||participants|||Number
779669|NCT00793455|Primary|Colorectal Cancer Screening Completion.|"We reviewed electronic health records of participants 3 months post randomization to ascertain outcome. We looked for one or both of the following (1) note in free text MD note documenting receipt of one form of colorectal cancer (CRC) screening during study period (2)lab results from fecal occult blood test, sigmoidoscopy, or colonoscopy.
Participants were categorized as completing CRC screening if there was a lab result or physician note located in chart during study period. If no note or lab result was found in chart, then the participant was categorized as not completing CRC screening."|3 months post randomization|Analysis was based on intention to treat.||participants|||Number
779670|NCT00793520|Primary|Change in Medium Pressure Pain Threshold From Baseline to End of Treatment.|Pain intensity is rated using the Gracely Box Scale, where 0 is no pain sensation and 20 is extremely intense. Painful blunt pressure is applied to the thumbnail of the patient's left hand. A software system will determine medium(rated as 7 or 8) and high pain (rated as 13 or 14) thresholds at baseline, week 5 and at a second baseline at week 7 and week 12.|Week 0, 5, 7 and 12|||Kg||95% Confidence Interval|Mean
779671|NCT00793520|Secondary|Change in Diffuse Noxious Inhibitory Control (DNIC) Effect From Baseline to End of Treatment.|DNIC is evaluated using a conditioning stimulus and a test stimulus. Painful blunt pressure is applied to the thumbnail of the patient's left hand for 30 sec. Patient rates pain experienced on numerical scale of 0(no pain) to 100(worst pain) at 10, 20 & 30 sec. This is repeated 3 times and a mean pain score is calculated. 5 minutes following test stimulus, patient’s right hand is immersed in 12C water at 30 sec test stimulus is reapplied and a 2nd mean pain score is calculated. The difference in mean pain rating before and after conditioning stimulus indicates presence and magnitude of DNIC|Weeks 0, 5, 7 and 12|||Pain Rating||95% Confidence Interval|Mean
779672|NCT00793546|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)]|AUC (0-24)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-24).|0 hour (pre-dose) on Day 1, 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 29|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.|||||
779675|NCT00793546|Secondary|Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS)|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeter (mm) = worst imaginable health state to 100 mm =best imaginable health state; higher scores indicate a better health state.|Part 2 Baseline, Week 12, 2 to 6 weeks after last dose|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.|||||
779676|NCT00793546|Secondary|Euro Quality of Life (EQ-5D)- Health State Profile Utility Score|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Part 2 Baseline, Week 12, 2 to 6 weeks after last dose|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.|||||
779677|NCT00793546|Secondary|Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B)|FACT-B is used for assessment of health-related quality of life (QoL) in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and additional concerns on breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures ranges from 0=‘Not at all’ to 4=‘Very much’. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Part 2 Baseline, Week 12, 2 to 6 weeks after last dose|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.|||||
779678|NCT00793546|Secondary|Duration of Response (DR)|Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Part 2 Baseline, every 8 weeks up to 2 to 6 weeks after last dose|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.|||||
779679|NCT00793546|Secondary|Overall Survival (OS)|Time in weeks from randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Part 2 Baseline until death or up to 24 months|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.|||||
779680|NCT00793546|Secondary|Percentage of Participants With Objective Response|Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as greater than or equal to >=30 percent (%) decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study >=4 weeks after initial documentation of response.|Part 2 Baseline, every 8 weeks up to 2 to 6 weeks after last dose|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.|||||
779681|NCT00793546|Secondary|Progression Free Survival (PFS) Based on Investigator|"Time in weeks from randomization to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of randomization plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Part 2 Baseline, every 8 weeks up to 2 to 6 weeks after last dose|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.|||||
779682|NCT00793546|Secondary|Percentage of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to 28 days after the last dose|Safety population included all participants who received at least 1 dose of study medication.||percentage of participants|||Number
779683|NCT00793546|Primary|Progression Free Survival (PFS) Based on Independent Radiologist|"Time in weeks from randomization to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of randomization plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Part 2 Baseline, every 8 weeks up to 2 to 6 weeks after last dose|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.|||||
779684|NCT00793572|Secondary|OS|Estimated by the method of Kaplan and Meier. Confidence intervals will be estimated.|At 2 years after the autograft|||Participants|||Count of Participants
779685|NCT00793572|Secondary|Non-relapse Mortality|Confidence intervals will be estimated. Assessed at 200 days and 1 year after allograft.|200 and 365 days after allo|||Participants|||Count of Participants
779686|NCT00793572|Secondary|Incidence of Toxicities Related to Bortezomib Maintenance Therapy After the Stem Cell Transplantation|Confidence intervals will be estimated.|Up to 100 days after the autograft or allograft|||Participants|||Count of Participants
779687|NCT00793572|Secondary|Incidence of Chronic GVHD|Confidence intervals will be estimated.|1 year post allo|||Participants|||Count of Participants
779695|NCT00793624|Primary|Mahler Transitional Dyspnea Index Focal Score at 24 Weeks for Combined Analysis|This outcome measure describes the combined analysis of the trials NCT00793624 and NCT00796653. Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 24|Full analysis sets (FAS) of the trials NCT00793624 and NCT00796653. FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||score on a scale||Standard Error|Mean
779696|NCT00793624|Secondary|Changes in Safety Parameters Related to Treatment|Occurence of cardiac disorders and investigations related to treatment.|48 weeks|Treated set.||percentage of participants|||Number
779697|NCT00793624|Secondary|Absolute Plasma Concentrations|Absolute plasma concentrations of Olodaterol. Values presented are across visits and summarised into geometric means.|within 2 hours before first drug administration and 10 minutes post-dose at week 6, 12 and 18|Pharmacokinetic set includes all patients in the treated set who had at least one valid olodaterol plasma concentration measurement after initial administration of study drug. This set is restricted to patients in either the Olodaterol 5 μg or 10 μg dose group.||pg/mL||Geometric Coefficient of Variation|Geometric Mean
779698|NCT00793624|Secondary|Number of Moderate Chronic Obstructive Pulmonary Disease (CPOD) Exacerbations|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations did not lead to hospitalization but included treatment with antibiotics and/or systemic steroids.|Baseline to end of study at 48 weeks.|Treated set- all patients who received at least one dose of study medication||Number of COPD ex. per patient year||Standard Error|Mean
779699|NCT00793624|Secondary|Number of COPD Exacerbations Requiring Hospitalization|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations required hospitalization.|Baseline to end of study at week 48 visit|Treated set- all patients who received at least one dose of study medication||Number of COPD ex. per patient year||Standard Error|Mean
779700|NCT00793624|Secondary|Number of COPD Exacerbations|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria.|Baseline to end of study at week 48 visit|Treated set- all patients who received at least one dose of study medication||Number of COPD ex. per patient year||Standard Error|Mean
779701|NCT00793624|Secondary|Time to First Moderate Chronic Obstructive Pulmonary Disease (CPOD) Exacerbation|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations did not lead to hospitalization but included treatment with antibiotics and/or systemic steroids. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor.|Baseline to end of study at 48 weeks.|Treated set- all patients who received at least one dose of study medication||Days||95% Confidence Interval|Mean
779702|NCT00793624|Secondary|Time to First Chronic Obstructive Pulmonary Disease (CPOD) Exacerbation Leading to Hospitalization|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations required hospitalization. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor.|Baseline to end of study at 48 weeks.|Treated set- all patients who received at least one dose of study medication||Days||95% Confidence Interval|Mean
779703|NCT00793624|Secondary|Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor.|Baseline to end of study at 48 weeks.|Treated set- all patients who received at least one dose of study medication||Days||95% Confidence Interval|Mean
779704|NCT00793624|Secondary|Mahler Transitional Dyspnea Index Focal Score at 48 Weeks|Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 48|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||score on a scale||Standard Error|Least Squares Mean
779705|NCT00793624|Secondary|Mahler Transitional Dyspnea Index Focal Score at 40 Weeks|Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 40|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||score on a scale||Standard Error|Least Squares Mean
779706|NCT00793624|Secondary|Mahler Transitional Dyspnea Index Focal Score at 32 Weeks|Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 32|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||score on a scale||Standard Error|Least Squares Mean
779707|NCT00793624|Secondary|Mahler Transitional Dyspnea Index Focal Score at 18 Weeks|Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 18|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||score on a scale||Standard Error|Least Squares Mean
779708|NCT00793624|Secondary|Mahler Transitional Dyspnea Index Focal Score at 12 Weeks|Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 12|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||score on a scale||Standard Error|Least Squares Mean
779709|NCT00793624|Secondary|Mahler Transitional Dyspnea Index Focal Score at 6 Weeks|Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 6|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||score on a scale||Standard Error|Least Squares Mean
779710|NCT00793624|Secondary|Patient's Global Rating (PGR) at 48 Weeks|Patient's Global Rating (PGR) was a patient assessment of their health (respiratory condition) at each visit (compared to the day before they started study drug) and ranged from 1 (very much better) to 7 (very much worse).|Week 48|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||score on a scale||Standard Error|Least Squares Mean
779711|NCT00793624|Secondary|Patient's Global Rating (PGR) at 24 Weeks|Patient's Global Rating (PGR) was a patient assessment of their health (respiratory condition) at each visit (compared to the day before they started study drug) and ranged from 1 (very much better) to 7 (very much worse).|Week 24|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||score on a scale||Standard Error|Least Squares Mean
779712|NCT00793624|Secondary|Patient's Global Rating (PGR) at 12 Weeks|Patient's Global Rating (PGR) was a patient assessment of their health (respiratory condition) at each visit (compared to the day before they started study drug) and ranged from 1 (very much better) to 7 (very much worse).|Week 12|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||score on a scale||Standard Error|Least Squares Mean
779713|NCT00793624|Secondary|Patient's Global Rating (PGR) at 6 Weeks|Patient's Global Rating (PGR) was a patient assessment of their health (respiratory condition) at each visit (compared to the day before they started study drug) and ranged from 1 (very much better) to 7 (very much worse).|Week 6|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||score on a scale||Standard Error|Least Squares Mean
779714|NCT00793624|Secondary|Use of Rescue Medication at Week 24|Mean number of puffs of rescue medication used per day (daytime/nighttime/total)|Week 24|FAS||Number of puffs||Standard Error|Mean
779715|NCT00793624|Secondary|Peak Expiratory Flow Rate (PEFR) at Week 24|Weekly mean pre-dose morning and evening PEFR. Results are from non−MMRM ANCOVA models by week, with Last observation carried forward (LOCF) up to each week. Fixed effects include treatment, tiotropium, strata and baseline.|Week 24|FAS||L/min||Standard Error|Mean
779716|NCT00793624|Secondary|Peak FVC (0-3h) Response After 48 Weeks|Response was defined as change from baseline. Baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
779725|NCT00793624|Secondary|Trough FVC Response at Week 18|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 18.|FAS||Liter||Standard Error|Least Squares Mean
779717|NCT00793624|Secondary|Peak FVC (0-3h) Response After 24 Weeks|Response was defined as change from baseline. Baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
779718|NCT00793624|Secondary|Peak FVC (0-3h) Response After 12 Weeks|Response was defined as change from baseline. Baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 12 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
779719|NCT00793624|Secondary|Peak FVC (0-3h) Response After 6 Weeks|Response was defined as change from baseline. Baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
779720|NCT00793624|Secondary|Peak FVC (0-3h) Response After 2 Weeks|Response was defined as change from baseline. Baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
779721|NCT00793624|Secondary|Trough FVC Response at Week 40|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 40.|FAS||Liter||Standard Error|Least Squares Mean
779722|NCT00793624|Secondary|Trough FVC Response at Week 48|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 48.|FAS||Liter||Standard Error|Least Squares Mean
779723|NCT00793624|Secondary|Trough FVC Response at Week 32|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 32.|FAS||Liter||Standard Error|Least Squares Mean
779724|NCT00793624|Secondary|Trough FVC Response at Week 24|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 24.|FAS||Liter||Standard Error|Least Squares Mean
780882|NCT00791258|Secondary|Percentage of Participants Previously on a Diuretic Achieving the Blood Pressure Goals From Baseline to 20 Weeks||Baseline to 20 weeks|Participants previously on a diuretic who have received at least one dose of study medication and who have a baseline value.||Percentage of participants|||Number
779726|NCT00793624|Secondary|Trough FVC Response at Week 12|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 12.|FAS||Liter||Standard Error|Least Squares Mean
779727|NCT00793624|Secondary|Trough FVC Response at Week 6|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 6.|FAS||Liter||Standard Error|Least Squares Mean
779728|NCT00793624|Secondary|Trough FVC Response at Week 2|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 2.|FAS||Liter||Standard Error|Least Squares Mean
779729|NCT00793624|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 48 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 48|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
779730|NCT00793624|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 24 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 24|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
779731|NCT00793624|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 12 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 12|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
779732|NCT00793624|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 6 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 6|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
779733|NCT00793624|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 2 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 2|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
779734|NCT00793624|Secondary|Peak FEV1 (0-3h) Response After 48 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
779735|NCT00793624|Secondary|Peak FEV1 (0-3h) Response After 24 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
779736|NCT00793624|Secondary|Peak FEV1 (0-3h) Response After 12 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 12 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
779737|NCT00793624|Secondary|Peak FEV1 (0-3h) Response After 6 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
779738|NCT00793624|Secondary|Peak FEV1 (0-3h) Response After 2 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
779739|NCT00793624|Secondary|Trough FEV1 Response at Week 48|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 48.|FAS||Liter||Standard Error|Least Squares Mean
779757|NCT00793650|Secondary|Response Rate Using EBMT(European Group for Blood and Bone Marrow Transplan) Criteria at Day +100 After Transplant.|"CR :Negative immunofixation on the serum and urine and Disappearance of any soft tissue plasmacytomas and <=5% plasma cells in bone marrow.
VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100mg per 24 hour.
Partial Response:>=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to <200mg per 24 hour."|100 days after transplant|As per the protocol.||participants|||Number
779740|NCT00793624|Secondary|Trough FEV1 Response at Week 40|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 40.|FAS||Liter||Standard Error|Least Squares Mean
779741|NCT00793624|Secondary|Trough FEV1 Response at Week 32|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 32.|FAS||Liter||Standard Error|Least Squares Mean
779742|NCT00793624|Secondary|Trough FEV1 Response at Week 18|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 18.|FAS||Liter||Standard Error|Least Squares Mean
779743|NCT00793624|Secondary|Trough FEV1 Response at Week 12|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 12.|FAS||Liter||Standard Error|Least Squares Mean
779744|NCT00793624|Secondary|Trough FEV1 Response at Week 6|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 6.|FAS||Liter||Standard Error|Least Squares Mean
779745|NCT00793624|Secondary|Trough FEV1 Response at Week 2|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 2.|FAS||Liter||Standard Error|Least Squares Mean
779746|NCT00793624|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 48 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 48|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
779747|NCT00793624|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 12 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 12|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
779748|NCT00793624|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 6 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 6|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
779749|NCT00793624|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 2 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 2|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
779750|NCT00793624|Secondary|Saint George's Respiratory Questionnaire (SGRQ) Total Score at 24 Weeks for Combined Analysis|Saint George's Respiratory Questionnaire (SGRQ) measures the impact of COPD on overall health, daily life, and perceived well-being ranging from 0 (no limitations) to 100 (most limitations). This is a combined analysis of the data from NCT00793624 and NCT00796653 showing adjusted values using a MMRM model.|Baseline, Week 24|Full analysis sets (FAS) of the trials NCT00793624 and NCT00796653. FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||score on a scale||Standard Error|Mean
779751|NCT00793624|Secondary|Saint George's Respiratory Questionnaire (SGRQ) Total Score at 48 Weeks|Saint George's Respiratory Questionnaire (SGRQ) measures the impact of COPD on overall health, daily life, and perceived well-being ranging from 0 (no limitations) to 100 (most limitations).|Baseline, Week 48|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||score on a scale||Standard Error|Least Squares Mean
779752|NCT00793624|Secondary|Saint George's Respiratory Questionnaire (SGRQ) Total Score at 12 Weeks|Saint George's Respiratory Questionnaire (SGRQ) measures the impact of COPD on overall health, daily life, and perceived well-being ranging from 0 (no limitations) to 100 (most limitations).|Baseline, Week 12|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||score on a scale||Standard Error|Least Squares Mean
779753|NCT00793624|Secondary|Saint George's Respiratory Questionnaire (SGRQ) Total Score at 24 Weeks|Saint George's Respiratory Questionnaire (SGRQ) measures the impact of COPD on overall health, daily life, and perceived well-being ranging from 0 (no limitations) to 100 (most limitations).|Baseline, Week 24|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||score on a scale||Standard Error|Least Squares Mean
779754|NCT00793624|Primary|Mahler Transitional Dyspnea Index Focal Score at 24 Weeks|Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 24|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||score on a scale||Standard Error|Least Squares Mean
779755|NCT00793624|Primary|Trough FEV1 Response at Week 24|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 24.|FAS||Liter||Standard Error|Least Squares Mean
779756|NCT00793624|Primary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 24 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 24|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
779765|NCT00793793|Secondary|Accumulation Ratio of the Analyte in Plasma Following Multiple Doses Over a Uniform Dosing Interval: RAauc|For TN patients, comparing exposure on Day 14 to the first dose on Day 1; for TE patients, comparing exposure on Day 28 to the first dose on Day 1.|Day 1, Day 14, and Day 28|TS including patients with available RAauc data||ratio||Geometric Coefficient of Variation|Geometric Mean
779766|NCT00793793|Secondary|Accumulation Ratio of the Analyte in Plasma Following Multiple Doses Over a Uniform Dosing Interval: RAcmax|For TN patients, comparing exposure on Day 14 to the first dose on Day 1; for TE patients, comparing exposure on Day 28 to the first dose on Day 1.|Day 1, Day 14, and Day 28|TS including patients with available RAcmax data||ratio||Geometric Coefficient of Variation|Geometric Mean
779767|NCT00793793|Secondary|PK Parameter for Drug-drug Interaction (naïve Patients With ≥1 Log Reduction on Day 10): Cmin, ss|PK parameter for drug-drug interaction (naïve patients with ≥1 log reduction on Day 10): Cmin, ss.|Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to administration of trial medication in the morning of Day 14 (on day 14)|TS (for TN patients only)||ng/mL||Geometric Coefficient of Variation|Geometric Mean
779768|NCT00793793|Secondary|PK Parameter for Drug-drug Interaction (naïve Patients With ≥1 Log Reduction on Day 10): Cmax,ss|PK parameter for drug-drug interaction (naïve patients with ≥1 log reduction on Day 10): Cmax,ss.|Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to administration of trial medication in the morning of Day 14 (on day 14)|TS (for TN patients only)||ng/mL||Geometric Coefficient of Variation|Geometric Mean
779769|NCT00793793|Secondary|PK Parameter for Drug-drug Interaction (naïve Patients With ≥1 Log Reduction on Day 10): AUCτ,ss (Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval τ )|PK parameter for drug-drug interaction (naïve patients with ≥1 log reduction on Day 10): AUCτ,ss ( Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ ).|Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to administration of trial medication in the morning of Day 14 (on day 14)|TS (for TN patients only)||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
779770|NCT00793793|Secondary|PK Parameter at Steady State After the Last Dose: Vz/F,ss (Apparent Volume of Distribution During the Terminal Phase z at Steady State Following an Oral Administration )|PK parameter at steady state after the last dose: Vz/F,ss (Apparent volume of distribution during the terminal phase z at steady state following an oral administration [L] )|Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)|TS including patients with available Vz/F,ss data||L||Geometric Coefficient of Variation|Geometric Mean
779771|NCT00793793|Secondary|PK Parameter at Steady State After the Last Dose: CL/F,ss (Apparent Clearance of the Analyte in Plasma at Steady State Following Multiple Oral Dose Administration )|PK parameter at steady state after the last dose (if applicable): CL/F,ss (ss Apparent clearance of the analyte in plasma at steady state following multiple oral dose administration [mL/min] )|Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)|TS including patients with available CL/F,ss data||mL/min||Geometric Coefficient of Variation|Geometric Mean
779772|NCT00793793|Secondary|PK Parameter at Steady State After the Last Dose: MRTpo,ss (Mean Residence Time of the Analyte in the Body at Steady State After Oral Administration)|PK parameter at steady state after the last dose: MRTpo,ss (Mean residence time of the analyte in the body at steady state after oral administration [h] )|Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)|TS including patients with available MRTpo,ss data||h||Geometric Coefficient of Variation|Geometric Mean
779773|NCT00793793|Secondary|PK Parameter at Steady State After the Last Dose: t1/2,ss (Terminal Half-life of the Analyte in Plasma at Steady State )|PK parameter at steady state after the last dose: t1/2,ss (Terminal half-life of the analyte in plasma at steady state [h] )|Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)|TS including patients with available t1/2,ss data||h||Geometric Coefficient of Variation|Geometric Mean
779774|NCT00793793|Secondary|PK Parameter at Steady State After the Last Dose: AUCτ,ss (Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval τ)|PK parameter at steady state after the last dose: AUCτ,ss ((Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ).|Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)|TS including patients with available AUCτ,ss data||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
779775|NCT00793793|Secondary|PK Parameter at Steady State After the Last Dose: Cmin,ss (Minimum Measured Concentration of the Analyte in Plasma)|PK parameter at steady state after the last dose: Cmin,ss (Minimum measured concentration of the analyte in plasma).|Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)|TS including patients with available Cmin,ss data||ng/mL||Geometric Coefficient of Variation|Geometric Mean
779970|NCT00783796|Secondary|In-stent % Diameter Stenosis|Value calculated as 100*(1-MLD/RVD) where MLD is in-stent minimum lumen diameter and RVD is in-stent reference vessel diameter.|240 days|Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).||Percentage||Standard Deviation|Mean
779776|NCT00793793|Secondary|PK Parameter at Steady State After the Last Dose: Tmax,ss (Time From Last Dosing to the Maximum Measured Concentration of the Analyte in Plasma at Steady State )|PK parameter at steady state after the last dose: tmax,ss (Time from last dosing to the maximum measured concentration of the analyte in plasma at steady state ).|Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)|TS including patients with available tmax,ss data||h||Geometric Coefficient of Variation|Geometric Mean
779777|NCT00793793|Secondary|PK Parameter at Steady State After the Last Dose: Cmax,ss (Maximum Measured Concentration of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval τ)|PK parameter at steady state after the last dose: Cmax,ss (Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ).|Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)|TS including patients with available Cmax,ss data||ng/mL||Geometric Coefficient of Variation|Geometric Mean
779778|NCT00793793|Secondary|PK Parameter After the First Dose: AUCτ,1 (Area Under the Concentration-time Curve of the Analyte in Plasma Over a Uniform Dosing Interval τ on Day 1)|PK parameter after the first dose: AUCτ,1 (Area under the concentration-time curve of the analyte in plasma over a uniform dosing interval τ on day 1).|Times of -0:15, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, and 16:00 h relative to first administration of trial medication (on day 1)|TS||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
779779|NCT00793793|Secondary|PK Parameter After the First Dose: Tmax (Time From (Last) Dosing to the Maximum Measured Concentration of the Analyte in Plasma)|PK parameter after the first dose: tmax (Time from (last) dosing to the maximum measured concentration of the analyte in plasma).|Times of -0:15, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, and 16:00 h relative to first administration of trial medication (on day 1)|TS||h||Geometric Coefficient of Variation|Geometric Mean
779780|NCT00793793|Secondary|PK (Pharmacokinetic) Parameter After the First Dose: Cmax ( Maximum Measured Concentration of the Analyte in Plasma)|PK (pharmacokinetic) parameter after the first dose: Cmax ( Maximum measured concentration of the analyte in plasma ).|Times of -0:15, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, and 16:00 h relative to first administration of trial medication (on day 1)|TS||ng/mL||Geometric Coefficient of Variation|Geometric Mean
779781|NCT00793793|Secondary|Occurrence of Discontinuations Due to AEs During BI201335 or BI201335+PegIFN/RBV Combination Treatment Period|Occurrence of discontinuations due to AEs during BI201335 or BI201335+PegIFN/RBV combination treatment period.|from day 1 and up to 4 weeks|TS||percentage of participants discontinued|||Number
779782|NCT00793793|Secondary|Occurrence of AEs, by Action Taken With Regard to Study Medication|Occurrence of AEs, by action taken with regard to study medication.|from day 1 and up to 4 weeks|TS||percentage of participants|||Number
779783|NCT00793793|Secondary|Achievement of a >= 2 log10 Reduction in Plasma HCV RNA Level From Baseline Over Time|Achievement of a >= 2 log10 reduction in plasma HCV RNA level from baseline over time.|from day 1 and up to 4 weeks|FAS||percentage of participants|||Number
779784|NCT00793793|Secondary|Achievement of an HCV RNA Level Below the Limit of Quantification Over Time|Achievement of an HCV RNA Level Below the Limit of quantification of the Roche COBAS Taqman HCV/HPS assay (25 IU/mL) Over Time|from day 1 and up to 4 weeks|FAS||percentage of participants|||Number
779785|NCT00793793|Secondary|Achievement of an HCV RNA Level Below the Limit of Detection Over Time|Achievement of an HCV RNA level below the limit of detection of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) over time|from day 1 and up to 4 weeks|FAS||percentage of participants|||Number
779786|NCT00793793|Secondary|Sustained Virologic Response (SVR)|Sustained Virologic Response (SVR): Plasma HCV RNA level below the limit of detection of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) at week 72 (Day 504).|week 72|FAS||percentage of responders|||Number
779787|NCT00793793|Secondary|End of Treatment Response (ETR)|End of Treatment Response (ETR): Plasma HCV RNA level below the limit of detection of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) at week 48 (Day 336).|week 48|FAS||percentage of responders|||Number
779788|NCT00793793|Secondary|Complete EVR2 (cEVR2)|VL below the limit of detection at both 4 weeks and 12 weeks|week 4 and week 12|FAS||percentage of responders|||Number
779789|NCT00793793|Secondary|Complete EVR1 (cEVR1)|VL (Viral load) below the limit of quantification of the Roche COBAS Taqman HCV/HPS assay (25 IU/mL) at 4 weeks and below the limit of detection of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) at 12 weeks|week 4 and week 12|FAS||percentage of responders|||Number
779790|NCT00793793|Secondary|Early Virologic Response (EVR)|Early Virologic Response (EVR): >=2 log10 reduction in plasma HCV RNA level from baseline at week 12 (day 84)|week 12|FAS||percentage of responders|||Number
779791|NCT00793793|Secondary|Rapid Virologic Response (RVR)|Rapid virologic response (RVR): Plasma HCV RNA level below the limit of detection of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) on Day 28 for all patients.|week 4|FAS (as randomized)||percentage of responders||95% Confidence Interval|Number
779792|NCT00793793|Secondary|Change From Baseline in Viral Load on Day 14 for Treatment-naïve Patients and on Day 28 Treatment for Treatment-experienced Patients|Change from baseline in viral load on Day 14 for treatment-naïve patients and on Day 28 treatment for treatment-experienced patients.|Baseline and up to 4 weeks|FAS (as randomised) including patients with available viral load data.||Log10 IU/mL||Inter-Quartile Range|Median
779793|NCT00793793|Secondary|Maximum Viral Load Reduction From Baseline up to Day 14 for Treatment-naïve Patients and Day 28 Treatment for Treatment-experienced Patients|Maximum viral load reduction from baseline up to Day 14 for treatment-naïve patients and Day 28 treatment for treatment-experienced patients.|Baseline and up to 4 weeks|FAS (as randomised)||log10 IU/mL||Inter-Quartile Range|Median
779794|NCT00793793|Primary|Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time|"Occurrence of laboratory test abnormalities and with respect to Division of AIDS (DAIDS) classification and laboratory test values change over time.
ALT=Alanine transaminase (SGPT), AST=Aspartate transaminase (SGOT)."|Baseline and up to 4 weeks|TS||participants with grade 3 or 4 abnormal|||Number
779795|NCT00793793|Primary|Occurrence of Serious Adverse Events (SAEs) During BI201335 + Washout Period|Occurrence of Serious Adverse Events (SAEs)during BI201335 or BI201335+ washout period. For placebo patients include all SAEs through 30 days after trial discontinuation.|from day 1 and up to 4 weeks + 4 days washout|TS||percentage of participants with SAEs|||Number
779796|NCT00793793|Primary|Occurrence of Adverse Events (AEs) During BI201335 + Washout Period|Occurrence of Adverse Events (AEs) during BI201335 + washout period. For placebo patients include all AEs through 30 days after trial discontinuation.|from day 1 and up to 4 weeks + 4 days washout|Treated Set (TS): This patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment regardless of randomization.||percentage of participants with AEs|||Number
779797|NCT00793793|Primary|Efficacy: VR (Virologic Response) of >=2 log10 Reduction in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) From Baseline at Any Time up to Day 14 (naïve Patients) or Day 28 (Experienced Patients)|Efficacy endpoint: VR (virologic response) of >=2 log10 reduction in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) from baseline at any time up to Day 14 (naïve patients) or Day 28 (experienced patients).|Baseline and up to 4 weeks|Full Analysis Set (FAS): All randomized TN patients and treatment experienced patients who were dispensed trial medication and were documented to have taken at least 1 dose of trial medication.||percentage of responders||95% Confidence Interval|Number
779798|NCT00793819|Primary|Change in Nocturia Episodes||12 weeks|The number of participants for analysis is determined by Last Observation Carried Forward (LOCF).||episodes||Standard Deviation|Mean
779799|NCT00793871|Secondary|Eastern Cooperative Oncology Group (ECOG) Performance Status|ECOG was used to assess participants' performance status: 0 (Fully active, able to carry on all pre-disease activities without restriction); 1 (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work or office work); 2 (Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours); 3 (Capable of only limited self-care, confined to bed or chair more than 50% of waking hours); 4 (Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair); and 5 (Dead).|Baseline (Day 1), Last-on treatment visit (up to 28 days post last administration of study drug)|Safety analysis set included all participants who started study treatment.||participants|||Number
779800|NCT00793871|Secondary|Number of Participants With Significant Vital Signs Changes From Baseline|Vital signs included blood pressure (BP), temperature, heart rate, respiration rate and body weight. The criteria for significant changes included BP: systolic BP (SBP) greater than (>) 150 millimeters of mercury (mm Hg) and/or diastolic BP (DBP) > 100 mm Hg, or SBP > 200 mm Hg and/or DBP > 110 mm Hg; temperature: >38.3 degrees Celsius (degrees C), or increase of greater than or equal to (>=)1.1 degrees C (baseline >=36.8 degrees C); heart rate: >120 beats per minute (bpm) or less than (<) 50 bpm, or increase of >=30 bpm or decrease of ≥30 bpm; respiration rate: > 40 /minute or < 8 /minute; weight: a change of 5% or more from baseline.|Baseline (Day 1) up to 28 days post last administration of study drug|Safety analysis set included all participants who started study treatment.||participants|||Number
779801|NCT00793871|Secondary|Number of Participants With Significant Changes From Baseline in Physical Examination.|Physical examinations including, but not limited to, general appearance, skin, neck, eyes, ears, nose, mouth, throat, breast, lungs, heart, abdomen, rectal, lymph nodes, extremities, thyroid, musculoskeletal, and nervous system were performed.|Baseline up to 28 days post last administration of study drug|Safety analysis set included all participants who started study treatment.||participants|||Number
779802|NCT00793871|Secondary|Number of Participants With Abnormal Clinical Laboratory Measurements|The total number of participants with laboratory test abnormalities without regard to baseline abnormality was assessed. Laboratory parameters included hematology (hemoglobin, platelets, white blood cell count, lymphocytes, neutrophils, basophils, eosinophils and monocytes), liver function (total bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, total protein and albumin), renal function (blood urea nitrogen, creatinine and uric acid), electrolytes (sodium, potassium, chloride, calcium, magnesium and phosphate), hormones (thyroxine and thyroid stimulating hormone), clinical chemistry (glucose), and urinalysis (urine protein) tests.|Baseline up to 28 days post last administration of study drug|Safety analysis set included all participants who started study treatment.||participants|||Number
779803|NCT00793871|Other Pre-specified|Time to Tumor Response (TTR)|TTR was defined as the time (in weeks) from the date of the first dose of study treatment to the date of the first documentation of objective tumor response (CR or PR based on RECIST, version 1.0) that was subsequently confirmed.|Baseline (Day 1) to tumor response (up to 82 weeks)|All participants who started study treatment (safety analysis set) had a confirmed objective tumor response.||weeks||95% Confidence Interval|Median
779804|NCT00793871|Secondary|Time to Tumor Progression (TTP)|TTP was defined as the time (in weeks) from the date of the first treatment to the date of the first documentation of objective tumor progression or death due to tumor progression. Participants last known to be 1) alive,2) on treatment or within 28 days of discontinuation from treatment and 3) progression-free were censored at the date of last objective disease assessment that verified lack of disease progression. Participants with no post baseline assessments were censored at the start date. Participants who died without prior objective disease progression and participants who discontinued treatment without objective disease progression within 28 days of last dose were censored at the date of the last objective disease assessment that verified lack of disease progression. Disease progression is defined using RECIST version 1.0.|Baseline (Day 1) up to objective tumor progression or death due to tumor progression (up to 264 weeks)|Safety analysis set included all participants who started study treatment.||weeks||95% Confidence Interval|Median
779805|NCT00793871|Secondary|Objective Response Rate (ORR)|ORR was defined as the proportion of participants who achieved an objective response. A participant was considered to have an objective response if a confirmed best response of complete response (CR) or partial response (PR) was achieved according to RECIST, version 1.0. CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeters (mm). PR is at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|Baseline (Day 1) up to end of study treatment (up to 276 weeks)|The per-protocol analysis set included all enrolled participants who had the disease under study, measurable disease and an adequate baseline disease assessment, and who started study treatment.||% of participants||95% Confidence Interval|Number
779806|NCT00793871|Secondary|Overall Survival (OS)|"OS was defined as the time (in weeks) from the date of the first treatment to the date of death due to any cause.
In the absence of confirmation of death, survival time was censored at the last date the participant was known to be alive."|Baseline (Day 1) to death (up to 282 weeks)|Safety analysis set included all participants who started study treatment.||weeks||95% Confidence Interval|Median
779807|NCT00793871|Primary|Progression-free Survival (PFS)|PFS was defined as the time (in weeks) from the date of the first treatment to the date of the first documentation of objective tumor progression or death due to any cause, whichever occurred first. Participants last known to be 1) alive, 2) on study treatment or discontinued study treatment, but haven’t yet started a new anticancer treatment and 3) progression-free were censored at the date of the last objective disease assessment that verified lack of disease progression. Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST version 1.0), as a >=20% increase in the sum of the longest dimensions of the target lesions taking as a reference the smallest sum of the longest dimensions recorded since the treatment started, or the appearance of one or more new lesions.|Baseline (Day 1) up to disease progression or death whichever occurred first (up to 264 weeks)|Safety analysis included all participants who started study treatment.||weeks||95% Confidence Interval|Median
779808|NCT00793910|Primary|Level of Pain|level of pain was measured using the Visual Analog Scale (VAS)ranging from 0 (none) to 10 (worst possible pain)|4 days postoperatively|11 patients who had alcohol-assisted PRK were removed from data analysis; 1 patient was disenrolled due to nausea secondary to oxycodone-acetaminophen (Percocet) intake||units on a scale||Standard Deviation|Mean
779809|NCT00793910|Primary|Level of Pain|level of pain was measured using the Visual Analog Scale (VAS)ranging from 0 (none) to 10 (worst possible pain)|3 days postoperatively|11 patients who had alcohol-assisted PRK were removed from data analysis; 1 patient was disenrolled due to nausea secondary to oxycodone-acetaminophen (Percocet) intake||units on a scale||Standard Deviation|Mean
779810|NCT00793910|Primary|Level of Pain|level of pain was measured using the Visual Analog Scale (VAS)ranging from 0 (none) to 10 (worst possible pain)|day 1 postoperatively|11 patients who had alcohol-assisted PRK were removed from data analysis; 1 patient was disenrolled due to nausea secondary to oxycodone-acetaminophen (Percocet) intake||units on a scale||Standard Deviation|Mean
779811|NCT00793910|Secondary|Occurence of Use of Rescue Medication|Occurrence of use of either ketorolac eyedrops(Acular) or oxycodone-acetaminophen tablet (Percocet), or both was measured|2 hours to 4 days postoperatively|11 patients who had alcohol-assisted PRK were removed from data analysis; 1 patient was disenrolled due to nausea secondary to oxycodone-acetaminophen (Percocet) intake||# of times rescue meds were used||Standard Deviation|Mean
779812|NCT00793910|Primary|Level of Pain|level of pain was measured using the Visual Analog Scale (VAS)ranging from 0 (none) to 10 (worst possible pain)|2 hours postoperatively|11 patients who had alcohol-assisted PRK were removed from data analysis; 1 patient was disenrolled due to nausea secondary to oxycodone-acetaminophen (Percocet) intake||units on a scale||Standard Deviation|Mean
779813|NCT00783432|Secondary|Adult Mini-Rhinoconjuctivitis Quality of Life Questionnaire. Change From Baseline in RQLQ Score at Months 1,3,6,9 and 12/or Early Termination.|The RQLQ consists of 7 domains rated on a 7-point scale with 0 being not troubled by the allergy symptoms,and 6 being extremely troubled. Total possible RQLQ score is 42 at any given evaluation. Scale of how troubled is:0=Not,2=Somewhat,3=Moderate,4=Quite a bit,5=Very,6 Extremely. Only change from baseline to month 12 primary analysis is provided.|baseline, months 1,3,6,9 and 12/or early termination|Analysis is based on safety population, which is defined as subjects who took at least one dose of study medication.||Units on a scale||Standard Deviation|Least Squares Mean
779814|NCT00783432|Primary|Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.|Examination of head and neck(scale: 0, 1+=Mild, 2+=Moderate, 3++Severe) for mucosal edema, nasal discharge, mucosal erythema, mucosal bleeding, mucosal ulcerations, crusting of mucosa, conjunctiva, tympanic membranes, lymph nodes of head and neck. Direct visual nasal examination (scale: None, Grade 2, Grade 3, and Grade 4) for epistaxis,ulceration and pain.|baseline and 12 months/ET|||Participants|||Number
779815|NCT00783432|Primary|Number of Participants Reporting Adverse Events|An AE can be any unfavorable and unintended sign,symptom, or disease temporally associated with the use of this investigational product, whether or not considered related to the investigational product. An AE is any untoward medical occurrence in a subject which does not necessarily have a causal relationship with this treatment.|12 months|Number of participants for analysis was based on a safety population that included any subject who received at least one dose of study medication.||Participants|||Number
779816|NCT00783614|Primary|Blood Markers of Inflammation, Endothelial Injury, and Thrombosis||changes from baseline to 6 months||||||
779817|NCT00783614|Primary|Number of Participants With Side Effects (Self-report) Number of Participants With Adverse Events|At each visit participants were asked if they were experience side effects to study medications. They were also asked if any new events or symptoms occurred since the last visit, even if they did not suspect it was related to the study medication|6 months|The number of participants with adverse events or reporting side effects||participants|||Number
779818|NCT00783692|Secondary|Maintenance Phase: Percentage of Participants With Durable Clinical Remission|"Durable clinical remission is defined as CDAI score ≤ 150 points at 80% or more of study visits during the Maintenance Phase, including the Week 52 visit (11 of 13 study visits). The CDAI quantifies the symptoms of patients with Crohn's disease and consists of eight factors, summed after adjustment with a weighting factor. The total score ranges from 0 to 600 with higher scores indicating greater disease activity.
All participants who prematurely discontinued for any reason were considered as not achieving durable clinical remission"|Assessed every 4 weeks from Week 6 to Week 50, and at Week 52|Maintenance Study ITT Population||percentage of participants||95% Confidence Interval|Number
779819|NCT00783692|Secondary|Maintenance Phase: Percentage of Participants in Corticosteroid-free Clinical Remission at Week 52|"Participants using oral corticosteroids at Baseline, who discontinued corticosteroids and were in clinical remission (CDAI score ≤ 150) at Week 52 achieved corticosteroid-free clinical remission. The CDAI quantifies the symptoms of patients with Crohn's disease and consists of eight factors, summed after adjustment with a weighting factor. The total score ranges from 0 to 600 with higher scores indicating greater disease activity.
All participants who prematurely discontinued for any reason were considered as not achieving corticosteroid-free clinical remission."|Week 52|Maintenance Study ITT Population, participants who were on corticosteroids at Baseline.||percentage of participants||95% Confidence Interval|Number
779971|NCT00783796|Secondary|Distal Late Loss|Distal minimum lumen diameter (MLD) post-procedure minus distal MLD at angiographic follow-up (distal defined as 5 mm of healthy tissue distal to stent placement).|240 days|Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).||Millimeter||Standard Deviation|Mean
779820|NCT00783692|Secondary|Maintenance Phase: Percentage of Participants With Enhanced Clinical Response at Week 52|"Enhanced clinical response is defined as a CDAI score at least 100 points lower than the Baseline value. The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:
Number of liquid or soft stools each day for 7 days;
Abdominal pain (graded from 0-3 on severity) each day for 7 days;
General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;
Presence of complications;
Taking Lomotil or opiates for diarrhea;
Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);
Hematocrit of < 0.47 in men and < 0.42 in women;
Percentage deviation from standard weight.
The total score ranges from 0 to 600 with higher scores indicating greater disease activity.
All participants who prematurely discontinued for any reason were considered as not achieving enhanced clinical response."|Baseline and Week 52|Maintenance Study ITT Population||percentage of participants||95% Confidence Interval|Number
779821|NCT00783692|Secondary|Induction Phase: Change From Baseline in C-Reactive Protein (CRP) Levels at Week 6|C-reactive protein (CRP) is a protein found in the blood, the levels of which rise in response to inflammation. Normal concentration in healthy human serum is usually lower than 10 mg/L, slightly increasing with age. Higher levels indicate mild inflammation (10-40 mg/L) and active inflammation (40-200 mg/L).|Baseline and Week 6|Induction Study ITT Population; last observation carried forward (LOCF) imputation was used. Baseline CRP was missing for one participant in the placebo group.||mg/L||Full Range|Median
779822|NCT00783692|Primary|Maintenance Phase: Percentage of Participants Achieving Clinical Remission at Week 52|"Clinical remission is defined as a CDAI score ≤ 150. The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:
Number of liquid or soft stools each day for 7 days;
Abdominal pain (graded from 0-3 on severity) each day for 7 days;
General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;
Presence of complications;
Taking Lomotil or opiates for diarrhea;
Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);
Hematocrit of < 0.47 in men and < 0.42 in women;
Percentage deviation from standard weight.
The total score ranges from 0 to 600 with higher scores indicating greater disease activity.
All participants who prematurely discontinued for any reason were considered as not achieving clinical remission."|Week 52|Maintenance Study ITT Population, defined as all randomized participants who received vedolizumab during the Induction Phase and met the protocol definition of clinical response at Week 6, as assessed by the investigator, were randomized, and received any amount of double-blind study drug in the Maintenance Phase.||percentage of participants||95% Confidence Interval|Number
779823|NCT00783692|Primary|Induction Phase: Percentage of Participants With Enhanced Clinical Response at Week 6|"Enhanced clinical response is defined as a CDAI score at least 100 points lower than Baseline. The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:
Number of liquid or soft stools each day for 7 days;
Abdominal pain (graded from 0-3 on severity) each day for 7 days;
General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;
Presence of complications;
Taking Lomotil or opiates for diarrhea;
Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);
Hematocrit of < 0.47 in men and < 0.42 in women;
Percentage deviation from standard weight.
The total score ranges from 0 to 600 with higher scores indicating greater disease activity.
All participants who prematurely discontinued for any reason were considered as not achieving enhanced clinical response."|Baseline and Week 6|Induction Study ITT Population||percentage of participants||95% Confidence Interval|Number
779824|NCT00783692|Primary|Induction Phase: Percentage of Participants Achieving Clinical Remission at Week 6|"Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤ 150 points.
The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:
Number of liquid or soft stools each day for 7 days;
Abdominal pain (graded from 0-3 on severity) each day for 7 days;
General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;
Presence of complications;
Taking Lomotil or opiates for diarrhea;
Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);
Hematocrit of < 0.47 in men and < 0.42 in women;
Percentage deviation from standard weight.
The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.
All participants who prematurely discontinued for any reason were considered as not achieving clinical remission."|Week 6|Induction Study Intention to Treat (ITT) Population, which consisted of all randomized patients in Cohort 1 who received any amount of blinded study drug.||percentage of participants||95% Confidence Interval|Number
779825|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (SFTPD) in Plasma Samples as Assessed by ELISA|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available||ng/mL||Inter-Quartile Range|Median
779826|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (CC18) in Plasma Samples as Assessed by ELISA|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available||ng/mL||Inter-Quartile Range|Median
779972|NCT00783796|Secondary|Proximal Late Loss|Proximal minimum lumen diameter (MLD) post-procedure minus proximal MLD at angiographic follow-up (proximal defined as 5 mm of healthy tissue proximal to stent placement).|240 days|Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).||Millimeter||Standard Deviation|Mean
779827|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (Nitrotyrosine) in Plasma Samples as Assessed by ELISA|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available||mmol/L||Inter-Quartile Range|Median
779828|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (MPO) in Plasma Samples as Assessed by ELISA|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available||ng/mL||Inter-Quartile Range|Median
779829|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (CCL-2) in Plasma Samples as Assessed by ELISA|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available||pg/mL||Inter-Quartile Range|Median
779830|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (IL-6) in Plasma Samples as Assessed by ELISA|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available||pg/mL||Inter-Quartile Range|Median
779831|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (CRP) in Plasma Samples as Assessed by ELISA|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available||ng/mL||Inter-Quartile Range|Median
779832|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (CC-16) in Plasma Samples as Assessed by ELISA|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available||ng/mL||Inter-Quartile Range|Median
779833|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (Total Glutathione) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with bronchoalveolar lavage samples available||umol/L||Inter-Quartile Range|Median
779834|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (SFTPD) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with bronchoalveolar lavage samples available||ng/mL||Inter-Quartile Range|Median
779835|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (CC18) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with bronchoalveolar lavage samples available||ng/mL||Inter-Quartile Range|Median
779973|NCT00783796|Secondary|In-segment Late Loss (LL)|In-segment minimum lumen diameter (MLD) post-procedure minus in-segment MLD at angiographic follow-up.|240 Days|Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).||Millimeters||Standard Deviation|Mean
779836|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (MPO) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with bronchoalveolar lavage samples available||ng/mL||Inter-Quartile Range|Median
779837|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (CCL-2) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with bronchoalveolar lavage samples available||pg/mL||Inter-Quartile Range|Median
779838|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (IL-6) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with bronchoalveolar lavage samples available||pg/mL||Inter-Quartile Range|Median
779839|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (CC-16) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with bronchoalveolar lavage samples available||ng/mL||Inter-Quartile Range|Median
779840|NCT00783705|Secondary|Change in Gene Expression Profiles of RNA in Bronchial Brush Cell Samples as Assessed by Microarray||From baseline up to 6 months||||||
779841|NCT00783705|Secondary|Mean Percent Change in Ki-67 Expression Level in the Bronchial Biopsies With Dysplasia||From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with lesions biopsied.||percentage of Ki67 expression level||Standard Deviation|Mean
779842|NCT00783705|Secondary|Percent Change in the Number of Bronchial Dysplastic Lesions Before and After Treatment|The change in the number of bronchial dysplastic lesions is defined as disappearance or appearance of lesions.|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with lesions biopsied.||percentage change in number of lesions||Standard Deviation|Mean
779843|NCT00783705|Primary|Percentage of Participants With Response Determined by Change in the Histologic Grade of Bronchial Dysplasia as Measured by Mucosal Biopsy Samples on Lesion-specific Analysis.|"The definitions of responses are:
Complete response: the regression of a dysplastic lesion (DL) of any grade to one classified as being hyperplastic/normal; Progressive disease: appearance of lesions that were classified as mild dysplasia or worse; Stable disease: lesions that are not classified as complete response or progressive disease"|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy.||percentage of participants|||Number
779844|NCT00783705|Primary|Percentage of Participants With Response Determined by Change in the Histologic Grade of Bronchial Dysplasia as Measured by Mucosal Biopsy Samples on Participant-specific Analysis.|"The definitions of responses are:
Complete response: regression of all dysplastic lesion (DL) found at baseline to lesions that were no worse than hyperplasia and no new DL that were mild dysplasia or worse; Partial response: regression of some but not all of the DL with no new lesions that are mild dysplasia or worse; Progressive disease: progression of one or more sites by two or more grades or new DL that were mild dysplasia or worse; Stable disease: no complete response, partial response or progression."|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy.||percentage of participants|||Number
779845|NCT00783718|Secondary|Maintenance Phase: Percentage of Participants With Corticosteroid-free Remission at Week 52|"Clinical Remission is defined as a complete Mayo score of ≤ 2 points and no individual subscore > 1 point. Corticosteroid-free clinical remission is defined as participants using oral corticosteroids at baseline (Week 0) who discontinued corticosteroids and were in clinical remission at Week 52.
The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Each component is scored on a scale from 0 to 3 and the complete score ranges from 1 to 12 (higher scores indicate greater disease activity).
All participants who prematurely discontinued for any reason were considered as not achieving corticosteroid-free remission."|Week 52|Maintenance Study ITT Population, participants who were on corticosteroids at Baseline.||percentage of participants||95% Confidence Interval|Number
779974|NCT00783796|Secondary|In-Stent Late Loss|In-stent minimum lumen diameter (MLD) post-procedure minus in-stent MLD at angiographic follow-up.|240 days|Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).||Millimeters||Standard Deviation|Mean
779846|NCT00783718|Secondary|Maintenance Phase: Percentage of Participants With Durable Clinical Remission|"Durable clinical remission is defined as complete Mayo score of ≤ 2 points and no individual subscore > 1 point at both Weeks 6 and 52. The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Each component is scored on a scale from 0 to 3 and the complete score ranges from 1 to 12 (higher scores indicate greater disease activity).
All participants who prematurely discontinued for any reason were considered as not achieving durable clinical remission."|Week 6 and Week 52|Maintenance Study ITT Population||percentage of participants||95% Confidence Interval|Number
779847|NCT00783718|Secondary|Maintenance Phase: Percentage of Participants With Mucosal Healing at Week 52|"Mucosal healing is defined as a Mayo endoscopic subscore of ≤ 1 point.
The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Endoscopic findings were scored on a scale from 0 to 3 as follows:
0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern, mild friability); 2 = Moderate disease (marked erythema, lack of vascular pattern, friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).
All participants who prematurely discontinued for any reason were considered as not achieving mucosal healing."|Week 52|Maintenance Study ITT Population||percentage of participants||95% Confidence Interval|Number
779848|NCT00783718|Secondary|Maintenance Phase: Percentage of Participants With Durable Clinical Response|"Durable clinical response is defined as reduction in complete Mayo score of ≥ 3 points and ≥ 30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point at both Weeks 6 and 52. The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Each component is scored on a scale from 0 to 3 and the complete score ranges from 1 to 12 (higher scores indicate greater disease activity).
All participants who prematurely discontinued for any reason were considered as not achieving durable clinical response."|Baseline, Week 6 and Week 52|Maintenance Study ITT Population||percentage of participants||95% Confidence Interval|Number
779849|NCT00783718|Secondary|Induction Phase: Percentage of Participants With Mucosal Healing at Week 6|"Mucosal healing is defined as a Mayo endoscopic subscore of ≤ 1 point.
The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Endoscopic findings were scored on a scale from 0 to 3 as follows:
0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern, mild friability); 2 = Moderate disease (marked erythema, lack of vascular pattern, friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).
All participants who prematurely discontinued for any reason were considered as not achieving mucosal healing."|Week 6|Induction Study ITT Population||percentage of participants||95% Confidence Interval|Number
779850|NCT00783718|Secondary|Induction Phase: Percentage of Participants in Clinical Remission at Week 6|"Clinical Remission is defined as a complete Mayo score of ≤ 2 points and no individual subscore > 1 point.
The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Each component is scored on a scale from 0 to 3 and the complete score ranges from 1 to 12 (higher scores indicate greater disease activity).
All participants who prematurely discontinued for any reason were considered as not achieving clinical remission."|Week 6|Induction Study ITT Population||percentage of participants||95% Confidence Interval|Number
779851|NCT00783718|Primary|Maintenance Phase: Percentage of Participants in Clinical Remission at Week 52|"Clinical Remission is defined as a complete Mayo score of ≤ 2 points and no individual subscore > 1 point.
The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Each component is scored on a scale from 0 to 3 and the complete score ranges from 1 to 12 (higher scores indicate greater disease activity).
All participants who prematurely discontinued for any reason were considered as not achieving clinical remission."|Week 52|Maintenance Study ITT Population, defined as all randomized participants who received vedolizumab during the Induction Phase and met the protocol definition of clinical response at Week 6, as assessed by the investigator, were randomized, and received any amount of double-blind study drug in the Maintenance Phase.||percentage of participants||95% Confidence Interval|Number
779852|NCT00783718|Primary|Induction Phase: Percentage of Participants With a Clinical Response at Week 6|"Clinical response is defined as a reduction in complete Mayo score of ≥ 3 points and ≥ 30% from Baseline with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point.
The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Each component is scored on a scale from 0 to 3 and the complete score ranges from 1 to 12 (higher scores indicate greater disease activity).
All participants who prematurely discontinued for any reason were considered as not achieving clinical response."|Baseline and Week 6|Induction Study Intent-to-treat (ITT) population which consisted of all randomized patients in Cohort 1 who received any amount of blinded study drug.||percentage of participants||95% Confidence Interval|Number
779853|NCT00783796|Secondary|Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC)|ARC defined non-target vessel MI (MI clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).|5 years||||||
779854|NCT00783796|Secondary|Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC)|ARC defined non-target vessel MI (MI clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).|4 years||||||
779855|NCT00783796|Primary|Composite Rate of Cardiac Death, Target Vessel Myocardial Infarction (MI) (Per Protocol Definition) & Clinically Indicated Target Lesion Revascularization (CI-TLR).|This endpoint is a composite of cardiac death, target vessel myocardial infarction per protocol definition, and clinically-indicated target lesion revascularization.|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants|||Number
779856|NCT00783796|Primary|Composite Rate of Cardiac Death, Target Vessel Myocardial Infarction (MI) (Per Protocol Definition) & Clinically Indicated Target Lesion Revascularization (CI-TLR).|This endpoint is a composite of cardiac death, target vessel myocardial infarction per protocol definition, and clinically-indicated target lesion revascularization.|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants|||Number
779857|NCT00783796|Secondary|Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC)|ARC defined non-target vessel MI (MI clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||percentage of participants||95% Confidence Interval|Number
779858|NCT00783796|Secondary|Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC)|ARC defined non-target vessel MI (MI clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||percentage of participants||95% Confidence Interval|Number
779859|NCT00783796|Secondary|Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC)|ARC defined non-target vessel MI (MI clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of participants||95% Confidence Interval|Number
779860|NCT00783796|Secondary|Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC)|ARC defined non-target vessel MI (MI clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).|240 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of participants||95% Confidence Interval|Number
779861|NCT00783796|Secondary|Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC)|ARC defined non-target vessel MI (MI clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of participants||95% Confidence Interval|Number
779862|NCT00783796|Secondary|Target Vessel MI - Q-wave and Non Q-wave (Per ARC)|ARC defined target vessel MI (MI not clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).|5 years||||||
779863|NCT00783796|Secondary|Target Vessel MI - Q-wave and Non Q-wave (Per ARC)|ARC defined target vessel MI (MI not clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).|4 years||||||
779864|NCT00783796|Secondary|Target Vessel MI - Q-wave and Non Q-wave (Per ARC)|ARC defined target vessel MI (MI not clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||percentage of participants||95% Confidence Interval|Number
779865|NCT00783796|Secondary|Target Vessel MI - Q-wave and Non Q-wave (Per ARC)|ARC defined target vessel MI (MI not clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||percentage of participants||95% Confidence Interval|Number
779921|NCT00783796|Secondary|Cardiac Death/ All MI /CI-TLR|This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR).|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||percentage of participants||95% Confidence Interval|Number
779866|NCT00783796|Secondary|Target Vessel MI - Q-wave and Non Q-wave (Per ARC)|ARC defined target vessel MI (MI not clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
779867|NCT00783796|Secondary|Target Vessel MI - Q-wave and Non Q-wave (Per ARC)|ARC defined target vessel MI (MI not clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).|240 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
779868|NCT00783796|Secondary|Target Vessel MI - Q-wave and Non Q-wave (Per ARC)|ARC defined target vessel MI (MI not clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
779869|NCT00783796|Secondary|Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol)|Non target vessel myocardial infarction (MI) (MI clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).|4 years||||||
779870|NCT00783796|Secondary|Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol)|Non target vessel myocardial infarction (MI) (MI clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).|5 years||||||
779871|NCT00783796|Secondary|Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol)|Non target vessel myocardial infarction (MI) (MI clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||percentage of participants||95% Confidence Interval|Number
779872|NCT00783796|Secondary|Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol)|Non target vessel myocardial infarction (MI) (MI clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||percentage of participants||95% Confidence Interval|Number
779873|NCT00783796|Secondary|Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol)|Non target vessel myocardial infarction (MI) (MI clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
779874|NCT00783796|Secondary|Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol)|Non target vessel myocardial infarction (MI) (MI clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).|240 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
779875|NCT00783796|Secondary|Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol)|Non target vessel myocardial infarction (MI) (MI clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
779876|NCT00783796|Secondary|Clinically Indicated Target Lesion Revascularization (CI-TLR)|Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery) of the target lesion. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.|5 years||||||
793423|NCT00904371|Secondary|Change in Heart Rate From Baseline to Study End||Baseline to 3rd visit (4-10 months)|Patients with data both at baseline and on 3rd visit (4-10 months) and known diabetic status||Beats per minute||Standard Deviation|Mean
779877|NCT00783796|Secondary|Clinically Indicated Target Lesion Revascularization (CI-TLR)|Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery) of the target lesion. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.|4 years||||||
779878|NCT00783796|Secondary|Clinically Indicated Target Lesion Revascularization (CI-TLR)|Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery) of the target lesion. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms (per protocol).|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||percentage of participants||95% Confidence Interval|Number
779879|NCT00783796|Secondary|Clinically Indicated Target Lesion Revascularization (CI-TLR)|Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery) of the target lesion. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||percentage of participants||95% Confidence Interval|Number
779880|NCT00783796|Secondary|Clinically Indicated Target Lesion Revascularization (CI-TLR)|Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery) of the target lesion. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
779881|NCT00783796|Secondary|Clinically Indicated Target Lesion Revascularization (CI-TLR)|Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery) of the target lesion. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.|240 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
779882|NCT00783796|Secondary|Clinically Indicated Target Lesion Revascularization (CI-TLR)|Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery) of the target lesion. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
779883|NCT00783796|Secondary|Clinically Indicated Target Vessel Revascularization|Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery), of the target vessel. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.|5 years||||||
779884|NCT00783796|Secondary|Clinically Indicated Target Vessel Revascularization|Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery), of the target vessel. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.|4 years||||||
793605|NCT00907374|Primary|Microalbuminuria Reported as Urinary Albumin:Creatinine Ratio|Average of ratio for all participants during the 3-36 months of the study|3 to 36 months|||Ratio||Standard Deviation|Mean
779885|NCT00783796|Secondary|Clinically Indicated Target Vessel Revascularization|Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery), of the target vessel. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms (per protocol).|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||percentage of participants||95% Confidence Interval|Number
779886|NCT00783796|Secondary|Clinically Indicated Target Vessel Revascularization|Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery), of the target vessel. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||percentage of participants||95% Confidence Interval|Number
779887|NCT00783796|Secondary|Clinically Indicated Target Vessel Revascularization|Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery), of the target vessel. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
779888|NCT00783796|Secondary|Clinically Indicated Target Vessel Revascularization|Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery), of the target vessel. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.|240 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
779889|NCT00783796|Secondary|Clinically Indicated Target Vessel Revascularization (TVR)|Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery), of the target vessel. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
779890|NCT00783796|Secondary|All TLR (CI and Non-CI)|Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) of the target lesion from the index procedure. This includes interventions classified as clinically indicated, and also includes interventions classified as not clinically indicated.|5 years||||||
779891|NCT00783796|Secondary|All TLR (CI and Non-CI)|Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) of the target lesion from the index procedure. This includes interventions classified as clinically indicated, and also includes interventions classified as not clinically indicated.|4 years||||||
779892|NCT00783796|Secondary|All TLR (CI and Non-CI)|Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) of the target lesion from the index procedure. This includes interventions classified as clinically indicated, and also includes interventions classified as not clinically indicated (per protocol).|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||percentage of participants||95% Confidence Interval|Number
779893|NCT00783796|Secondary|All TLR (CI and Non-CI)|Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) of the target lesion from the index procedure. This includes interventions classified as clinically indicated, and also includes interventions classified as not clinically indicated.|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||percentage of participants||95% Confidence Interval|Number
779894|NCT00783796|Secondary|All TLR (CI and Non-CI)|Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) of the target lesion from the index procedure. This includes interventions classified as clinically indicated, and also includes interventions classified as not clinically indicated.|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
779895|NCT00783796|Secondary|All TLR (CI and Non-CI)|Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) of the target lesion from the index procedure. This includes interventions classified as clinically indicated, and also includes interventions classified as not clinically indicated.|240 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
779896|NCT00783796|Secondary|All TLR (CI and Non-CI)|Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) of the target lesion from the index procedure. This includes interventions classified as clinically indicated, and also includes interventions classified as not clinically indicated.|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
779897|NCT00783796|Secondary|All TVR (CI and Non-CI)|Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure.|5 years||||||
779898|NCT00783796|Secondary|All TVR (CI and Non-CI)|Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure.|4 years||||||
779899|NCT00783796|Secondary|All TVR (CI and Non-CI)|Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure (per protocol).|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||percentage of participants||95% Confidence Interval|Number
779900|NCT00783796|Secondary|All TVR (CI and Non-CI)|Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure.|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||percentage of participants||95% Confidence Interval|Number
779901|NCT00783796|Secondary|All TVR (CI and Non-CI)|Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure.|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
779902|NCT00783796|Secondary|All TVR (CI and Non-CI)|Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure.|240 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
779903|NCT00783796|Secondary|All TVR (CI and Non-CI)|Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure.|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
779904|NCT00783796|Secondary|All Coronary Revascularization (TVR and Non-TVR)|Includes any revascularization intervention after the index procedure by any means (percutaneous or bypass surgery), including intervention to the target vessel, and intervention to a vessel other than the target vessel.|5 years||||||
779905|NCT00783796|Secondary|All Coronary Revascularization (TVR and Non-TVR)|Includes any revascularization intervention after the index procedure by any means (percutaneous or bypass surgery), including intervention to the target vessel, and intervention to a vessel other than the target vessel.|4 years||||||
779906|NCT00783796|Secondary|All Coronary Revascularization (TVR and Non-TVR)|Includes any revascularization intervention after the index procedure by any means (percutaneous or bypass surgery), including intervention to the target vessel, and intervention to a vessel other than the target vessel (per protocol).|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||percentage of participants||95% Confidence Interval|Number
793698|NCT00908128|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.||µg/mL||Standard Deviation|Mean
779907|NCT00783796|Secondary|All Coronary Revascularization (TVR and Non-TVR)|Includes any revascularization intervention after the index procedure by any means (percutaneous or bypass surgery), including intervention to the target vessel, and intervention to a vessel other than the target vessel.|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||percentage of participants||95% Confidence Interval|Number
779908|NCT00783796|Secondary|All Coronary Revascularization (TVR and Non-TVR)|Includes any revascularization intervention after the index procedure by any means (percutaneous or bypass surgery), including intervention to the target vessel, and intervention to a vessel other than the target vessel.|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
779909|NCT00783796|Secondary|All Coronary Revascularization (TVR and Non-TVR)|Includes any revascularization intervention after the index procedure by any means (percutaneous or bypass surgery), including intervention to the target vessel, and intervention to a vessel other than the target vessel.|240 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
779910|NCT00783796|Secondary|All Coronary Revascularization (TVR and Non-TVR)|Includes any revascularization intervention after the index procedure by any means (percutaneous or bypass surgery), including intervention to the target vessel, and intervention to a vessel other than the target vessel.|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
779911|NCT00783796|Secondary|Cardiac Death/MI|This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.|5 years||||||
779912|NCT00783796|Secondary|Cardiac Death/MI|This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.|4 years||||||
779913|NCT00783796|Secondary|Cardiac Death/MI|This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||percentage of participants||95% Confidence Interval|Number
779914|NCT00783796|Secondary|Cardiac Death/MI|This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||percentage of participants||95% Confidence Interval|Number
779915|NCT00783796|Secondary|Cardiac Death/MI|This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
779916|NCT00783796|Secondary|Cardiac Death/MI|This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.|240 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
779917|NCT00783796|Secondary|Cardiac Death/MI|This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
779918|NCT00783796|Secondary|Cardiac Death/ All MI /CI-TLR|This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR).|5 years||||||
779919|NCT00783796|Secondary|Cardiac Death/ All MI /CI-TLR|This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR).|4 years||||||
779920|NCT00783796|Secondary|Cardiac Death/ All MI /CI-TLR|This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR).|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||percentage of participants||95% Confidence Interval|Number
779969|NCT00783796|Secondary|In-segment % Diameter Stenosis|Value calculated as 100*(1-MLD/RVD) where MLD is in-segment minimum lumen diameter and RVD is in-segment reference vessel diameter.|240 days|Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).||Percentage||Standard Deviation|Mean
779922|NCT00783796|Secondary|Cardiac Death/ All MI /CI-TLR|This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR).|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
779923|NCT00783796|Secondary|Cardiac Death/ All MI /CI-TLR|This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR).|240 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
779924|NCT00783796|Secondary|Cardiac Death/ All MI /CI-TLR|This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR).|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
779925|NCT00783796|Secondary|All Death/ All MI/All Coronary Revascularization|This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization.|5 years||||||
779926|NCT00783796|Secondary|All Death/ All MI/All Coronary Revascularization|This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization.|4 years||||||
779927|NCT00783796|Secondary|All Death/ All MI/All Coronary Revascularization|This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization.|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||percentage of participants||95% Confidence Interval|Number
779928|NCT00783796|Secondary|All Death/ All MI/All Coronary Revascularization|This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization.|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||percentage of participants||95% Confidence Interval|Number
779929|NCT00783796|Secondary|All Death/ All MI/All Coronary Revascularization|This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization.|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
779930|NCT00783796|Secondary|All Death/ All MI/All Coronary Revascularization|This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization.|240 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
779931|NCT00783796|Secondary|All Death/ All MI/All Coronary Revascularization|This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization.|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
779932|NCT00783796|Secondary|Stent Thrombosis (Protocol Defined)|Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.|Overall (0 - 1123 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||percentage of participants|||Number
779933|NCT00783796|Secondary|Stent Thrombosis (Protocol Defined)|Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.|Overall (0 - 758 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||percentage of participants|||Number
793699|NCT00908141|Primary|Prostate Specific Antigen (PSA) Response|The number of patients with PSA modulation defined as PSA decline of at least 50%|post treatment at 9 weeks|||participants|||Number
779934|NCT00783796|Secondary|Stent Thrombosis (Protocol Defined)|Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.|Overall (0 - 393 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||percentage of participants|||Number
779935|NCT00783796|Secondary|Stent Thrombosis (Protocol Defined)|Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.|31 - 1123 days (Late)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants|||Number
779936|NCT00783796|Secondary|Stent Thrombosis (Protocol Defined)|Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.|31 - 758 days (Late)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants|||Number
779937|NCT00783796|Secondary|Stent Thrombosis (Protocol Defined)|Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.|31 days to 393 days (Late)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants|||Number
779938|NCT00783796|Secondary|Stent Thrombosis (Protocol Defined)|Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.|> 1 day to 30 days (Subacute)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants|||Number
779939|NCT00783796|Secondary|Stent Thrombosis (Protocol Defined)|Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.|0 to 1 day (Acute)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants|||Number
779940|NCT00783796|Secondary|Stent Thrombosis (ARC Defined)|Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.|Overall (0 - 1123 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants|||Number
779941|NCT00783796|Secondary|Stent Thrombosis (ARC Defined)|Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.|Overall (0 - 758 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants|||Number
780346|NCT00802841|Secondary|Percentage of Participants With CCyr|CCyR was assessed from bone marrow samples. CCyr was defined as having 0% Philadelphia positive (Ph+) chromosome metaphases in bone marrow.|12 and 24 months|Full Analysis Set: The FAS included all participants to whom study treatment had been assigned by randomization.||Percentage of participants|||Number
779942|NCT00783796|Secondary|Stent Thrombosis (ARC Defined)|Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.|Overall (0 - 393 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants|||Number
779943|NCT00783796|Secondary|Stent Thrombosis (ARC Defined)|Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.|394 - 1123 days (Very Late)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants|||Number
779944|NCT00783796|Secondary|Stent Thrombosis (ARC Defined)|Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.|394 - 758 days (Very Late)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants|||Number
779945|NCT00783796|Secondary|Stent Thrombosis (ARC Defined)|Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.|>1 year (Very late)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants|||Number
779946|NCT00783796|Secondary|Stent Thrombosis (ARC Defined)|Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.|31 days - 393 days (Late)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants|||Number
779947|NCT00783796|Secondary|Stent Thrombosis (ARC Defined)|ARC defined: Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.|greater than 1 day to 30 days (Subacute)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants|||Number
779948|NCT00783796|Secondary|Stent Thrombosis (ARC Defined)|ARC defined: Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.|0 to 1 day (Acute)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants|||Number
779949|NCT00783796|Secondary|Target Vessel MI - Q-wave and Non Q-wave (Per Protocol)|Target vessel myocardial infarction (MI) (MI not clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).|5 years||||||
779950|NCT00783796|Secondary|Target Vessel MI - Q-wave and Non Q-wave (Per Protocol)|Target vessel myocardial infarction (MI) (MI not clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).|4 years||||||
779951|NCT00783796|Secondary|Target Vessel MI - Q-wave and Non Q-wave (Per Protocol)|Target vessel myocardial infarction (MI) (MI not clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||percentage of participants||95% Confidence Interval|Number
779952|NCT00783796|Secondary|Target Vessel MI - Q-wave and Non Q-wave (Per Protocol)|Target vessel myocardial infarction (MI) (MI not clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||percentage of participants||95% Confidence Interval|Number
779953|NCT00783796|Secondary|Target Vessel MI - Q-wave and Non Q-wave (Per Protocol)|Target vessel myocardial infarction (MI) (MI not clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
779954|NCT00783796|Secondary|Target Vessel MI - Q-wave and Non Q-wave (Per Protocol)|Target vessel myocardial infarction (MI) (MI not clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).|240 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
779955|NCT00783796|Secondary|Target Vessel MI - Q-wave and Non Q-wave (Per Protocol)|Target vessel myocardial infarction (MI) (MI not clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
779956|NCT00783796|Secondary|All Death (Cardiac, Vascular, Non-cardiovascular)|All death, including death from cardiac, vascular, and non-cardiovascular causes.|5 years||||||
779957|NCT00783796|Secondary|All Death (Cardiac, Vascular, Non-cardiovascular)|All death, including death from cardiac, vascular, and non-cardiovascular causes.|4 years||||||
779958|NCT00783796|Secondary|All Death (Cardiac, Vascular, Non-cardiovascular)|All death, including death from cardiac, vascular, and non-cardiovascular causes (per protocol).|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||percentage of participants||95% Confidence Interval|Number
779959|NCT00783796|Secondary|All Death (Cardiac, Vascular, Non-cardiovascular)|All death, including death from cardiac, vascular, and non-cardiovascular causes.|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||percentage of participants||95% Confidence Interval|Number
779960|NCT00783796|Secondary|All Death (Cardiac, Vascular, Non-cardiovascular)|All death, including death from cardiac, vascular, and non-cardiovascular causes.|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
779961|NCT00783796|Secondary|All Death (Cardiac, Vascular, Non-cardiovascular)|All death, including death from cardiac, vascular, and non-cardiovascular causes.|240 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
779962|NCT00783796|Secondary|All Death (Cardiac, Vascular, Non-cardiovascular)|All death, including death from cardiac, vascular, and non-cardiovascular causes.|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
779963|NCT00783796|Secondary|Distal Angiographic Binary Restenosis (ABR) Rate|Percentage of patients with target lesions with ≥ 50% diameter stenosis in 5 mm of healthy tissue distal to stent placement at angiographic follow-up.|240 days|Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).||Percentage of Participants||95% Confidence Interval|Number
779964|NCT00783796|Secondary|Proximal Angiographic Binary Restenosis (ABR) Rate|Percentage of patients with target lesions with ≥ 50% diameter stenosis in 5 mm of healthy tissue proximal to stent placement at angiographic follow-up.|240 days|Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).||Percentage of Participants||95% Confidence Interval|Number
779965|NCT00783796|Secondary|In-segment Angiographic Binary Restenosis (ABR) Rate|Percentage of patients with target lesions with ≥ 50% in-segment % diameter stenosis at angiographic follow-up.|240 days|Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).||Percentage of Participants||95% Confidence Interval|Number
779966|NCT00783796|Secondary|In-stent Angiographic Binary Restenosis (ABR) Rate|Percentage of patients with target lesions with ≥ 50% in-stent % diameter stenosis at angiographic follow-up.|240 days|Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).||Percentage of Participants||95% Confidence Interval|Number
779967|NCT00783796|Secondary|Distal % Diameter Stenosis|Value calculated as 100*(1-MLD/RVD) where MLD is minimum lumen diameter and RVD is reference vessel diameter in 5 mm of healthy tissue distal to stent placement.|240 days|Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).||Percentage||Standard Deviation|Mean
779968|NCT00783796|Secondary|Proximal % Diameter Stenosis|Value calculated as 100*(1-MLD/RVD) where MLD is minimum lumen diameter and RVD is reference vessel diameter in 5 mm of healthy tissue proximal to stent placement.|240 days|Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).||Percentage||Standard Deviation|Mean
779975|NCT00783796|Secondary|Procedural Success (Per Subject Basis, for ALL Target and Non-target Lesions)|Achievement of a final in-stent diameter stenosis of <50% using the study device, without the occurence of cardiac death, target vessel myocardial infarction per protocol definition, or repeat revascularization of the target lesion during the hospital stay up to 7 days.|From the start of index procedure to end of index procedure|Based on Intent To Treat (ITT) population, defined as subjects enrolled in the study, regardless of the treatment actually received, and excluding de-registered subjects.||Percentage of Participants|||Number
779976|NCT00783796|Secondary|Device Success (Per Lesion Basis, for Target Lesions Treated by 2.25 mm XIENCE V EECS With or Without Planned Overlap)|Successful delivery and deployment of the first study stent intended to be implanted at the intended target lesion (or intended first and second investigational stents for overlapping stents), successful withdrawal of the stent delivery system, and attainment of final residual stenosis of <50%.|From start of index procedure to end of index procedure|Based on Intent To Treat (ITT) population, defined as subjects enrolled in the study, regardless of the treatment actually received, and excluding de-registered subjects||Percentage of Lesions|Participants||Number
779977|NCT00783796|Primary|Composite Rate of Cardiac Death, Target Vessel Myocardial Infarction (MI) (Per Protocol Definition) & Clinically Indicated Target Lesion Revascularization (CI-TLR).|This endpoint is a composite of cardiac death, target vessel myocardial infarction per protocol definition, and clinically-indicated target lesion revascularization.|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants|||Number
779978|NCT00783835|Secondary|Change From Screening in the Hamilton Depression Rating (HAM-D) Scale Score at Week 4 and 12|It is a 21-item clinician-rated scale that evaluates depressed mood as well as the vegetative and cognitive symptoms of depression. 11 items are scored on a 3 point scale (0=none/absent to 2=most severe), 2 items are scored on a 4 point scale (0=none/absent to 3=most severe) and 8 items are scored on a 5 point scale (0=none/absent to 4=most severe). The individual items are summed to yield the HAM-D total score that ranges from 0-60, where higher scores indicate worsening.|Screening (Week -2), 4 and 12|ITTe included all participants who received at least 1 dose of study medication and provided at least 1 post-baseline measure of effectiveness.||Unit on a scale||Standard Error|Mean
779979|NCT00783835|Secondary|Change From Baseline in the State-Trait Anxiety Inventory (STAI) Scale|The STAI scale consists of total 40 items on separate scales measuring state (20 items) and trait (20 items) anxiety. The participant reports how they feel right now at this moment for state anxiety and how they generally feel for trait anxiety. The state items are scored as: 1 (not at all), 2 (somewhat true), 3 (moderately true), 4 (very true). The trait items are scored as: 1 (almost never), 2 (sometimes), 3 (often), 4 (almost always). The total scores range from 4-80 for each scale. Higher scores indicate more impaired participants.|Baseline, Week 4, 8 and 12|ITTe included all participants who received at least 1 dose of study medication and provided at least 1 post-baseline measure of effectiveness.||Unit on a scale||Standard Error|Mean
779980|NCT00783835|Secondary|Clinical Global Impression-Improvement (CGI-I) Score|The CGI-I is a 7-point scale that requires the clinician to assess how much the participant’s illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as (1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse).|Week 4, 8 and 12|ITTe included all participants who received at least 1 dose of study medication and provided at least 1 post-baseline measure of effectiveness.||Unit on a scale||Standard Error|Mean
779981|NCT00783835|Secondary|Change From Screening in Clinical Global Impression-Severity of Illness (CGI-S) Score at Weeks 4, 8 and 12|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 = Normal, not at all ill and a rating of 7 = Among the most extremely ill participants. Higher scores indicate worsening."|Screening (Week -2), 4, 8 and 12|ITTe included all participants who received at least 1 dose of study medication and provided at least 1 post-baseline measure of effectiveness.||Unit on a scale||Standard Error|Mean
779982|NCT00783835|Primary|Change From Baseline in Adult ADHD Quality of Life (AAQoL) Scale Score at Week 12|The AAQoL is a validated 29-item scale consisting of 4 subscales:life productivity (11 items), psychological health (6 items), life outlook (7 items) and relationships (5 items). Participants rate each item on a 5-point Likert - like scale ranging from 1 (not at all/never) to 5 (extremely/very often). These scores are then transformed to a 0-100 point scale, higher scores indicating better quality of life. Total score=average of individual 29 item scores (range= 0-100, where higher total score indicates better quality of life). Change from baseline in total score for AAQoL is reported.|Baseline and Week 12|ITTe included all participants who received at least 1 dose of study medication and provided at least 1 post-baseline measure of effectiveness.||Unit on a scale||Standard Error|Mean
779983|NCT00783835|Primary|Change From Baseline in Adult ADHD Quality of Life (AAQoL) Scale Score at Week 4|The AAQoL is a validated 29-item scale consisting of 4 subscales:life productivity (11 items), psychological health (6 items), life outlook (7 items) and relationships (5 items). Participants rate each item on a 5-point Likert - like scale ranging from 1 (not at all/never) to 5 (extremely/very often). These scores are then transformed to a 0-100 point scale, higher scores indicating better quality of life. Total score=average of individual 29 item scores (range= 0-100, where higher total score indicates better quality of life). Change from baseline in total score for AAQoL is reported.|Baseline and Week 4|ITTe included all participants who received at least 1 dose of study medication and provided at least 1 post-baseline measure of effectiveness.||Unit on a scale||Standard Error|Mean
779984|NCT00783835|Primary|Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Self-Report Scale (ASRS) Total Score at Week 12|Adult ASRS assesses 18 core ADHD symptoms corresponding to DSM-IV diagnostic symptoms for adult participant based on the participant's own rating for each of the symptoms using a 4 point scale (0=none, 1=mild, 2=moderate, 3=severe). If a single item is missing the score is imputed and if more than one item is missing, the total score is treated as missing. The ASRS total score is derived by summing the score assigned to each of the 18 symptoms (low=0, high=54, a higher score signifies a greater severity of symptoms).|Baseline and Week 12|ITTe included all participants who received at least 1 dose of study medication and provided at least 1 post-baseline measure of effectiveness.||Unit on a scale||Standard Error|Mean
779985|NCT00783835|Primary|Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Self-Report Scale (ASRS) Total Score at Week 8|Adult ASRS assesses 18 core ADHD symptoms corresponding to DSM-IV diagnostic symptoms for adult participant based on the participant's own rating for each of the symptoms using a 4 point scale (0=none, 1=mild, 2=moderate, 3=severe). If a single item is missing the score is imputed and if more than one item is missing, the total score is treated as missing. The ASRS total score is derived by summing the score assigned to each of the 18 symptoms (low=0, high=54, a higher score signifies a greater severity of symptoms).|Baseline and Week 8|ITTe included all participants who received at least 1 dose of study medication and provided at least 1 post-baseline measure of effectiveness.||Unit on a scale||Standard Error|Mean
779986|NCT00783835|Primary|Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Self-Report Scale (ASRS) Total Score at Week 4|Adult ASRS assesses 18 core ADHD symptoms corresponding to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnostic symptoms for adult participant based on the participant's own rating for each of the symptoms using a 4 point scale (0=none, 1=mild, 2=moderate, 3=severe). If a single item is missing the score is imputed and if more than one item is missing, the total score is treated as missing. The ASRS total score is derived by summing the score assigned to each of the 18 symptoms (low=0, high=54, a higher score signifies a greater severity of symptoms).|Baseline and Week 4|Intent to treat efficacy evaluation (ITTe) included all participants who received at least 1 dose of study medication and provided at least 1 post-baseline measure of effectiveness.||Unit on a scale||Standard Error|Mean
779987|NCT00783952|Primary|Determining the Accuracy of Mixed Venous Oxygen Saturation Obtained With a Novel Mathematical Equation Using Arterial Oxygen Saturations and Various Local Tissue Oxygen Saturations.|Four sensors of the 'Cerebral/Somatic Tissue Oximeter' device will be placed on subject's both sides of the forehead, palm and calf area. Simultaneously, blood samples will be drawn from the pulmonary artery catheter and arterial line for blood gas analyses. The values obtained from the device measurements will be used in a new equation to calculate the mixed venous oxygen saturation. The calculated value will be compared to the real value from the blood gas analysis for accuracy.|6 months|||percentage of oxygen saturation||Standard Deviation|Mean
779988|NCT00783965|Primary|Parameters of Safety: Number of Participants With Adverse Events According to NCI CTCAE v3.0||Baseline and 36 months|||participants|||Number
779989|NCT00783965|Primary|Number of Participants With Reduction in the Observed Numbers of Basal Cell Carcinomas ≥ 9 mm² in Diameter||Baseline and 36 months|||participants|||Number
779990|NCT00784030|Primary|Change in Urine cAMP Concentration and Urine Osmolality (UOsm)|Urine cAMP (UcAMP) concentration and urine osmolality UOsm) were measured pre- and post-water loading: with 2.5L over 2 hours|pre- and post-water loading (2 hours)|Number of participants was deemed to be adequate for the purposes of this pilot study||fold change in cAMP/UOsm (umol/UOsm)||Standard Error|Mean
779991|NCT00784095|Primary|QUAL-E Completion Sub-scale|A sub-scale of the QUAL-E quality of life at the end of life measures. The scale range was 5-35 with higher scores indicating more positive sense of completion.|Baseline, 6 and 8 week follow up|||units on a scale||Standard Deviation|Mean
779992|NCT00784095|Secondary|POMS Anxiety Sub-scale|The anxiety sub-scale from the modified Brief Profile of Mood States (POMS) is a 5-item measure of psychological distress.Items are on a 5-point likert scale with scoring ranging from 5-25. Higher scores indicate greater anxiety.|Baseline, 6 and 8 week follow ups|||units on a scale||Standard Deviation|Mean
779993|NCT00784095|Secondary|Center for Epidemiology Studies - Depression Scale (CES-D)|Center for Epidemiology Studies - Depression Scale (CES-D) is a 10-item measure of depression. Items are rated on a 4 point likert scale with total scores ranging from 0-30. Higher scores indicate greater depressive symptoms.|Baseline, 6 and 8 week follow up|||units on a scale||Standard Deviation|Mean
779994|NCT00784095|Secondary|Functional Status ADL|Rosow-Breslau Activities of Daily Living scale range 17-51 with higher scores indicating greater ability.|Baseline, 6 and 8 week follow ups|||units on a scale||Standard Deviation|Mean
779995|NCT00784095|Primary|Quality of Life - Preparation|Quality Of Life At The End Of Life (the QUAL-E 2009) is a 31 item measure of quality of life at the end of life assessing five domains: life completion, relationship with health care providers, preparation for death, physical symptoms and affective social support. The 4-item preparation sub-scale is a primary outcomes measure with each item scaled from 1 to 5 with a minimum of 5, maximum of 20 score with higher scores indicating better preparation.|Baseline, 6 and 8 week follow up|||units on a scale||Standard Deviation|Mean
779996|NCT00784134|Secondary|Quality of Life - EuroQol Visual Analogue Scale (EQ-VAS)|Assessment of SIS and EuroQol Visual Analog Scale by group. EuroQol Visual Analogue Scale (EQ-VAS) is a self-reported measure of health status. It is a marked scale where individuals draw a line to indicate their health, with end points of 0 (the worst health you can imagine) and 100 (the best health you can imagine).|180 days|All the non-missing EuroQol scores at 180 days were analyzed.||EuroQol score||Standard Deviation|Mean
779997|NCT00784134|Secondary|Quality of Life - Stroke Impact Scale (SIS) - Recovery|Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.|180 days|All the non-missing SIS scores at 180 days were analyzed.||SIS score||Standard Deviation|Mean
779998|NCT00784134|Secondary|Quality of Life - Stroke Impact Scale (SIS) - Participation|Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.|180 days|All the non-missing SIS scores at 180 days were analyzed.||SIS score||Standard Deviation|Mean
779999|NCT00784134|Secondary|Quality of Life - Stroke Impact Scale (SIS) - Emotion|Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.|180 days|All the non-missing SIS scores at 180 days were analyzed.||SIS score||Standard Deviation|Mean
780000|NCT00784134|Secondary|Quality of Life - Stroke Impact Scale (SIS) - Thinking|Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.|180 days|All the non-missing SIS scores at 180 days were analyzed.||SIS score||Standard Deviation|Mean
780001|NCT00784134|Secondary|Quality of Life - Stroke Impact Scale (SIS) - Communication|Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.|180 days|All the non-missing SIS scores at 180 days were analyzed.||SIS score||Standard Deviation|Mean
780002|NCT00784134|Secondary|Quality of Life - Stroke Impact Scale (SIS) - Activities of Daily Living|Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.|180 days|All the non-missing SIS scores at 180 days were analyzed.||SIS score||Standard Deviation|Mean
780003|NCT00784134|Secondary|Quality of Life - Stroke Impact Scale (SIS) - Hand Function|Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.|180 days|All the non-missing SIS scores at 180 days were analyzed.||SIS score||Standard Deviation|Mean
780004|NCT00784134|Secondary|Quality of Life - Stroke Impact Scale (SIS) - Mobility|Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.|180 days|All the non-missing SIS scores at 180 days were analyzed.||SIS score||Standard Deviation|Mean
780005|NCT00784134|Secondary|Quality of Life - Stroke Impact Scale (SIS) - Strength|Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.|180 days|All the non-missing SIS scores at 180 days were analyzed.||SIS score||Standard Deviation|Mean
780006|NCT00784134|Secondary|Functional Status - National Institutes of Health Stroke Scale (NIHSS)|Assessment of NIHSS, Barthel Index, eGOS (dichotomy and ordinal) by group. The National Institutes of Health Stroke Scale (NIHSS) is a 15-item scale that assesses language, motor function, sensory loss, consciousness, visual fields, extraocular movements, coordination, neglect, and speech. It is scored from 0 (no stroke symptoms) to 42 (severe stroke).|180 days|All the non-missing NIHSS scores at 180 days were analyzed.||NIHSS score||Inter-Quartile Range|Median
780007|NCT00784134|Secondary|Functional Status - Participants With Extended Glasgow Outcome (eGOS) Score >=Upper Severe Disability|Assessment of NIHSS, Barthel Index, eGOS (dichotomy and ordinal) by group. The extended Glasgow Outcome Scale (eGOS) is a global scale for functional outcome with eight categories: 1 - Death, 2 - Vegetative State, 3 - Lower Severe Disability, 4 - Upper Severe Disability, 5 - Lower Moderate Disability, 6 - Upper Moderate Disability, 7 - Lower Good Recovery, 8 - Upper Good Recovery.|180 days|All the non-missing eGOS scores at 180 days were analyzed.||% of participants with score>=4|||Number
780008|NCT00784134|Secondary|Functional Status - Barthel Index|Assessment of NIHSS, Barthel Index, eGOS (dichotomy and ordinal) by group. The Barthel Index (BI) assesses ten functional tasks of daily living, and each task provides a measure for level of independence. Scores range from 0 and 100, with a higher score indicating greater independence.|180 days|All the non-missing Barthel scores at 180 days were analyzed.||Barthel score||Standard Deviation|Mean
780009|NCT00784134|Secondary|Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Location (Non-Thalamic)|Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).|180 days|All patients with a non-thalamic blood clot location and a non-missing mRS score at 180 days were analyzed.||percentage of participants|||Number
780010|NCT00784134|Secondary|Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Location (Thalamic)|Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).|180 days|All patients with a thalamic blood clot location and a non-missing mRS score at 180 days were analyzed.||percentage of participants|||Number
780011|NCT00784134|Secondary|Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by IVH Size (Greater Than 50ml)|Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).|180 days|All patients with an IVH size greater than 50ml and a non-missing mRS score at 180 days were analyzed.||percentage of participants|||Number
780028|NCT00784134|Secondary|Intensity of Critical Care Management - All Infections|Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.|30 days|All patients that were enrolled in CLEAR III were analyzed.||% of participants with infections|||Number
780012|NCT00784134|Secondary|Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by IVH Size (20-50ml)|Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).|180 days|All patients with an IVH size between 20ml and 50ml and a non-missing mRS score at 180 days were analyzed.||percentage of participants|||Number
780013|NCT00784134|Secondary|Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by IVH Size (Less Than 20ml)|Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).|180 days|All patients with an IVH size less than 20ml and a non-missing mRS score at 180 days were analyzed.||percentage of participants|||Number
780014|NCT00784134|Secondary|Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Age (Over 65 Years)|Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).|180 days|All patients over 65 years of age with a non-missing mRS score at 180 days were analyzed.||Percentage of participants|||Number
780015|NCT00784134|Secondary|Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Age (65 Years or Under)|Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).|180 days|All patients 65 years of age or under with a non-missing mRS score at 180 days were analyzed.||Percentage of participants|||Number
780016|NCT00784134|Secondary|Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Gender (Male)|Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).|180 days|All male patients with a non-missing mRS score at 180 days were analyzed.||percentage of participants|||Number
780017|NCT00784134|Secondary|Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Gender (Female)|Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).|180 days|All female patients with a non-missing mRS score at 180 days were analyzed.||percentage of participants|||Number
780018|NCT00784134|Secondary|Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Race (White)|Assessment of modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).|180 days|All patients that reported they were White with a non-missing mRS score at 180 days were analyzed.||percentage of participants|||Number
780019|NCT00784134|Secondary|Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Race (African-American)|Assessment of modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).|180 days|All patients that reported they were African-American with a non-missing mRS score at 180 days were analyzed.||Percentage of participants|||Number
780020|NCT00784134|Secondary|Predicting Hazards of Death by Treatment Group|Cox Proportional Hazards Model is used to predict the hazards ratio by treatment group.|180 days|All patients that were enrolled in CLEAR III were analyzed.||percentage of participants|||Number
780021|NCT00784134|Secondary|Adverse and Serious Adverse Events|Assessment of number of adverse and serious adverse events by treatment group.|180 days|All patients that were enrolled in CLEAR III were analyzed.||percentage of participants|||Number
780022|NCT00784134|Secondary|Safety/Mortality - Systematic Bleeds Within 30 Days|Frequency of bacterial brain infections, symptomatic brain bleeds, and mortality.|30 days|All patients that were enrolled in CLEAR III were analyzed.||% of participants with systematic bleeds|||Number
780023|NCT00784134|Secondary|Safety/Mortality - Systematic Bleeds Within 72 Hours|Frequency of bacterial brain infections, symptomatic brain bleeds, and mortality.|72 hours|All patients that were enrolled in CLEAR III were analyzed.||% of participants with systematic bleeds|||Number
780024|NCT00784134|Secondary|Safety/Mortality - Bacterial Brain Infections Within 30 Days|Frequency of bacterial brain infections, symptomatic brain bleeds, and mortality.|30 days|All patients that were enrolled in CLEAR III were analyzed.||% of participants with brain infection|||Number
780025|NCT00784134|Secondary|Safety/Mortality - Mortality Within 30 Days|Frequency of bacterial brain infections, symptomatic brain bleeds, and mortality.|30 days|All patients that were enrolled in CLEAR III were analyzed.||Percentage of patients|||Number
780026|NCT00784134|Secondary|Intensity of Critical Care Management - All Infections|Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.|180 days|All patients that were enrolled in CLEAR III were analyzed.||% of participants with infections|||Number
780027|NCT00784134|Secondary|Intensity of Critical Care Management - Pneumonia|Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.|30 days|All patients that were enrolled in CLEAR III were analyzed.||% of participants with pneumonia|||Number
780031|NCT00784134|Secondary|Intensity of Critical Care Management - Mechanical Ventilation|Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.|30 days|All patients that were enrolled in CLEAR III were analyzed.||% of participants with ventilation|||Number
780032|NCT00784134|Secondary|Intensity of Critical Care Management - ICP Management|Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.|30 days|All patients that were enrolled in CLEAR III were analyzed.||Percentage of events of ICP >20mmHg|||Number
780033|NCT00784134|Secondary|Intensity of Critical Care Management - ICU Days|Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.|30 days|All patients that were enrolled in CLEAR III were analyzed.||Number of days||Inter-Quartile Range|Median
780034|NCT00784134|Secondary|Intensity of Critical Care Management - Hospital Days|Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.|30 days|All patients that were enrolled in CLEAR III were analyzed.||Number of days||Inter-Quartile Range|Median
780035|NCT00784134|Secondary|Clot Removal (Amount of Residual Blood)|Change in blood volume measured between stability scan and end of treatment scan|72 hours|All patients that were enrolled in CLEAR III were analyzed.||odds ratio per time-weighted ml|||Number
780036|NCT00784134|Secondary|All Cause Mortality||180 days|All patients that were enrolled in CLEAR III were analyzed.||percentage of participants|||Number
780037|NCT00784134|Primary|Longitudinal Assessment of Participants With Modified Rankin Scale (mRS) <=3|Comparing longitudinal modified Rankin Scale (mRS) scores 0-3 at Day 30 and Day 180. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).|30 days and 180 days|All the non-missing mRS scores at 30 days and 180 days were analyzed.||Percentage of participants|||Number
780038|NCT00784134|Primary|Random Effects Assessment of Site Effect on Modified Rankin Scale (mRS) <= 3|The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).|180 days|All the non-missing mRS scores at 180 days were analyzed.||percentage of participants|||Number
780039|NCT00784134|Primary|Participants With Modified Rankin Scale (mRS) <=4 - Dichotomized Analysis|The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).|180 days|All the non-missing mRS scores at 180 days were analyzed.||percentage of participants|||Number
780040|NCT00784134|Primary|Participant Score on the Modified Rankin Scale (mRS) - Ordinal Analysis|The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).|180 days|All the non-missing mRS scores at 180 days were analyzed.||mRS score||Inter-Quartile Range|Median
780041|NCT00784134|Primary|Participants With Modified Rankin Scale (mRS) <=3 - Dichotomized Analysis|Analysis modified on September 29, 2015 to account for adaptive randomization. The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).|180 days|All the non-missing mRS scores at 180 days were analyzed.||percentage of participants|||Number
780042|NCT00784147|Secondary|Mean Change From Baseline in CD4+ T-Cell Count at Week 24/EOS|The mean change in CD4+ T-cell count from the Baseline measurement at Week 24/End of Study was summarized at each scheduled time point by treatment group.|Week 24 / End of Study|||cell/mL||Standard Deviation|Mean
780043|NCT00784147|Secondary|Mean Change From Baseline in Viral Load (log10) at Week 24/EOS|The mean change in HIV-1 RNA (log10) from the Baseline measurement was analyzed at Week 24/End of Study using a generalized linear model at each scheduled study visit.|Week 24 / End of Study|||log10 copies/mL||Standard Deviation|Mean
780044|NCT00784147|Other Pre-specified|Proportion of Patients With a 0.5 log10 or Greater Reduction in Viral Load at Week 24|This efficacy assessment was performed in the same manner as the primary efficacy analysis for the proportion of the total population achieving at least a 0.5 log10 reduction from the Baseline measurement in HIV-1 RNA at Week 24 of the study.|Week 24|||percentage of patients|||Number
780045|NCT00784147|Other Pre-specified|Proportion of Patients With a 1.0 log10 or Greater Reduction in Viral Load at Week 24|This efficacy assessment was performed in the same manner as the primary efficacy analysis for the proportion of the total population achieving at least a 1.0 log10 reduction from Baseline in HIV-1 RNA.|Week 24|||percentage of patients|||Number
780046|NCT00784147|Other Pre-specified|Proportion of Patients With Viral Load <400 Copies/mL at Week 24|This efficacy measure was assessed in the same manner as the primary efficacy analysis to determine the proportion of the total population achieving HIV-1 RNA levels <400 copies at Week 24 of the study.|Week 24|||percentage of patients|||Number
780047|NCT00784147|Other Pre-specified|Proportion of Patients With Viral Load <200 Copies/mL at Week 24|This measure was assessed in the same manner as the primary efficacy analysis for the proportion of patients achieving HIV-1 RNA levels below 200 copies/mL at Week 24 of the study.|Week 24|||percentage of patients|||Number
780048|NCT00784147|Primary|The Proportion of Patients Achieving Undetectable Viral Loads at Week 24.|"For the primary efficacy analysis, undetectable was defined as having HIV-1 RNA below the limit of assay detection at <50 copies/mL. The primary efficacy endpoint was analyzed using Fisher exact test. The primary analysis was performed using the ITT population and both the missing data equals treatment failure (MEF) and last observation carried forward (LOCF) methods. The more conservative MEF results are recorded here."|24 weeks|||percentage of participants|||Number
780049|NCT00784238|Secondary|Change From Baseline in Daytime Drowsiness Based on Visual Analog Scale at Week 24|"Daytime drowsiness was assessed by an 11-point visual analog scale that rates how well participants slept. Participants indicated on the scale (from 0 to 100 millimeter) how often they felt drowsy in the previous 7 days (from 0: very badly to 100: very well). Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics."|Baseline and Week 24|The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.||Millimeter (mm)||Standard Deviation|Mean
780050|NCT00784238|Secondary|Change From Baseline in Sleep Quality Based on Visual Analog Scale at Week 24|"Sleep quality was assessed by an 11-point visual analog scale that rates how well participants slept. Participants indicated on the scale (from 0 to 100 millimeter) how well they slept in the previous 7 days (from 0: very badly to 100: very well). Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics."|Baseline and Week 24|The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.||Millimeter (mm)||Standard Deviation|Mean
780051|NCT00784238|Secondary|Change From Baseline in Total Personal and Social Performance (PSP) Score at Week 24|The PSP scale assesses the degree of dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less or equal to 30, functioning so poorly as to require intensive supervision. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
780052|NCT00784238|Secondary|Change From Baseline in Krawiecka Scale Score at Week 24|Psychopathology of participants was assessed by Krawiecka scale. Psychopathology of participants was assessed by Krawiecka scale, score ranges from 0 to 16. Higher score indicates worsening of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
780053|NCT00784238|Secondary|Change From Baseline in Symptom Checklist 90-R (SCL90-R) at Week 24|The SCL90-R (Derogatis, 1992) measures 9 domains, including somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism, which provides a global index of distress, the Global Severity Index (GSI). SCL-90-R includes 90 items rated on 5-point scale, ranging from 0 (not at all) to 4 (extremely). Total scale score range from 0 to 360. Higher scores indicate worsening of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|"The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. N (number of participants analyzed) signifies the participants evaluable for this measure."||Units on a scale||Standard Deviation|Mean
780054|NCT00784238|Primary|Change From Baseline in Drug Attitude Inventory (DAI-10) at Week 24|The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. It is the binary scale assessing the participant's subjective response. A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive subjective response (SR); a negative sum of scores indicates a negative SR (non-compliant). The final score is the grand total of the positive and negative points. Total score ranges from (-) 10 to (+) 10, higher score indicates positive SR (compliant) and lower score indicates negative SR (non-compliant). Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
780055|NCT00784238|Primary|Drug Attitude Inventory (DAI-10) Total Score at Week 24|The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. It is the binary scale assessing the participant's subjective response. A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive subjective response (SR); a negative sum of scores indicates a negative SR (non-compliant). The final score is the grand total of the positive and negative points. Total score ranges from (-) 10 to (+) 10, higher score indicates positive SR (compliant) and lower score indicates negative SR (non-compliant).|Week 24|The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
780062|NCT00784238|Primary|Subjective Well-being Under Neuroleptic (SWN-20) Scale Total Score at Week 24|The SWN-20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self-control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood.|Week 24|Intent to treat (ITT) population for efficacy included all the participants who received paliperidone extended-release (ER) at least once and who had at least 1 post baseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
780056|NCT00784238|Primary|Change From Baseline in Social Integration Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24|The SWN-20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self-control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood. Social integration subscale score ranges from 0 to 24 and higher score indicates improvement of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
780057|NCT00784238|Primary|Change From Baseline in Physical Functioning Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24|The SWN-20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self-control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood. Physical Functioning subscale score ranges from 0 to 24 and higher score indicates improvement of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
780058|NCT00784238|Primary|Change From Baseline in Emotional Regulation Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24|The SWN-20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self-control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood. Emotional Regulation subscale score ranges from 0 to 24 and higher score indicates improvement of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
780059|NCT00784238|Primary|Change From Baseline in Self-Control Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24|The SWN-20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self-control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood. Self-Control subscale score ranges from 0 to 24 and higher score indicates improvement of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
780060|NCT00784238|Primary|Change From Baseline in Mental Functioning Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24|The SWN-20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self-control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood. Mental functioning subscale score ranges from 0 to 24 and higher score indicates improvement of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
780061|NCT00784238|Primary|Change From Baseline in Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24|The SWN-20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self-control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
780535|NCT00789074|Secondary|Change in Pre-quit End-expired Carbon Monoxide Reading (CO)|"Carbon monoxide concentration is measured in particles per million. It indicates smoke intake.
CO was measured at each contact to monitor changes in smoke intake and differences between the study arms."|Baseline - week 8|Participants that provided data at all time points||ppm||Standard Deviation|Mean
780063|NCT00784277|Primary|Spontaneous Bowel Movements Per Week (SBMs/Week)|The number of SBM over the 14-day IR treatment phase was determined from the Bowel Function Patient Diary and factored to enable a per week value to be used. An SBM is defined as any BM that has occurred without the use of a laxative, enema, suppository, or manual manipulation within the previous 24 hours.|Week 1 to Week 2|Intention To Treat (ITT) population : One participant who has been treated is not included in the ITT population as no baseline pain assessment was available (Arm: Tapentadol 50 mg).||number of stools/week||Standard Deviation|Mean
780064|NCT00784277|Primary|5-Day Sum of Pain Intensity Difference (SPID5)|SPID5 was calculated as the weighted (weights is taken as the number of hours elapsed since the previous measurement) sum of the PID collected up to 5 days. Pain intensity (PI) score is calculated as the average PI over the past 12 hours using an 11-point (0 to 10) numerical rating scale (NRS) where “0” is no pain and “10” is pain as bad as you can imagine. The difference between baseline PI at the qualifying period and current PI is pain intensity difference (PID).|Day 1 to Day 5|Intention To Treat (ITT) population : One participant who has been treated is not included in the ITT population as no baseline pain assessment was available (Arm: Tapentadol 50 mg).||Units on a scale||Standard Deviation|Mean
780065|NCT00784368|Secondary|Number of Participants With Change in the Endoscopy or Image Diagnosis by Diagnosis Name (Centralized Assessment)|Level of Improvement in Endoscopy was assessed as disappeared, decreased, improved, no change, worsened and could not be assessed. The cases evaluated were candidemia, esophageal candidiasis, invasive aspergillosis, C.N.P.A, P.A. and P.C.|Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI Switched treatment)|The FAS population. As per planned analysis both SFI arms were combined for efficacy analyses; participants with FN with suspected fungal infection were not planned to be analyzed for this outcome measure. Here, 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively.||participants|||Number
780066|NCT00784368|Secondary|Number of Participants With Change In the Endoscopy or Image Diagnosis By Centralized Assessment|Level of Improvement in the Endoscopy or Image diagnosis was assessed as disappeared (if the abnormal findings were normalized), decreased (if level of pathogenic fungus was decreased in culture), improved (if significant improvement was observed in the abnormal findings), no change (if no significant improvement was observed in the abnormal findings), worsened (if the abnormal findings were worsened) and could not be assessed (if it was difficult to make the above-noted assessments due to a reason such as a lack of detection in the tests before and after dosing).|Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI and FN Switched treatment)|The FAS population included all participants except those who did not meet main eligibility criteria, who did not receive ITCZ-IV or ITCZ-OS and participants without efficacy data. As per planned analysis both SFI (ITCZ Oral Solution Monotherapy) and SFI (Switched Treatment) arms were combined for all efficacy analyses.||participants|||Number
780067|NCT00784368|Secondary|Number of Participants With Serologic Effect Against Fungi by Diagnosis Name (Centralized Assessment)|Serological effect against fungi was assessed as changed to negative (if the test values became negative), improved (if the test values decreased), no change (if there was no change in the test values), worsened (if the test values increased) and could not be assessed (if it was difficult to make above-noted assessments due to a reason such as a lack of detection in the tests before and after dosing). The cases evaluated were candidemia, esophageal candidiasis, invasive aspergillosis, C.N.P.A, P.A. and P.C.|Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI Switched treatment)|The FAS population. As per planned analysis both SFI arms were combined for efficacy analyses; participants with FN with suspected fungal infection were not planned to be analyzed for this outcome measure. Here, 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively.||participants|||Number
780068|NCT00784368|Secondary|Number of Participants With Serological Effect Against Fungi by Centralized Assessment|Serological effect against fungi was assessed as changed to negative (if the test values became negative), improved (if the test values decreased), no change (if there was no change in the test values), no change (if there was no change in the test values) , worsened (if the test values increased) and could not be assessed (if it was difficult to make the above-noted assessments due to a reason such as a lack of detection in the tests before and after dosing).|Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI and FN Switched treatment)|The FAS population included all participants except those who did not meet main eligibility criteria, who did not receive ITCZ-IV or ITCZ-OS and participants without efficacy data. As per planned analysis both SFI (ITCZ Oral Solution Monotherapy) and SFI (Switched Treatment) arms were combined for all efficacy analyses.||participants|||Number
780069|NCT00784368|Secondary|Number of Participants With Mycological Efficacy by Diagnosis Name (Centralized Assessment)|Mycological efficacy was assessed as disappeared, decreased, no change, increased, could not be assessed. The cases evaluated were candidemia, esophageal candidiasis, invasive aspergillosis, C.N.P.A, P.A. and P.C.|Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI Switched treatment)|The FAS population. As per planned analysis both SFI arms were combined for efficacy analyses; participants with FN with suspected fungal infection were not planned to be analyzed for this outcome measure. Here, 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively.||participants|||Number
780070|NCT00784368|Secondary|Number of Participants With Mycological Efficacy by Centralized Assessment|Mycological efficacy was assessed as disappeared (if results for pathogenic fungus became negative, or if it was not possible to obtain the appropriate specimens), decreased (if level of pathogenic fungus was decreased in culture), no change (if there was no quantitative change in pathogenic fungus), increased (if there was a quantitative increase in pathogenic fungus, if results for pathogenic fungus became positive after start of dosing or if new pathogenic fungus was identified) , could not be assessed (if it was difficult to make the above assessment due to lack of detection in tests).|Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI and FN Switched treatment)|The FAS population included all participants except those who did not meet main eligibility criteria, who did not receive ITCZ-IV or ITCZ-OS and participants without efficacy data. As per planned analysis both SFI (ITCZ Oral Solution Monotherapy) and SFI (Switched Treatment) arms were combined for all efficacy analyses.||participants|||Number
780071|NCT00784368|Secondary|Percentage of Participants With Overall Response by Diagnosis Name (Centralized Assessment)|E.R. was calculated as number of cases for whom treatment was judged to be effective divided by sum of number of cases for whom treatment was judged to be effective and number of cases for whom treatment was judged to be ineffective multiplied by 100. T.S.R. was calculated as number of cases for whom treatment was judged to be effective divided by sum of number of cases for whom treatment was judged to be effective, number of cases for whom treatment was judged to be ineffective and number of cases for whom the efficacy could not be assessed multiplied by 100.|Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI Switched treatment)|The FAS population. As per planned analysis both SFI arms were combined for efficacy analyses; participants with FN with suspected fungal infection were not planned to be analyzed for this outcome measure. Here, 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively.||percentage of participants||95% Confidence Interval|Number
780072|NCT00784368|Secondary|Percentage of Participants With Overall Response by Centralized Assessment|Efficacy rate (E.R.) was calculated as number of cases for whom treatment was judged to be effective divided by sum of number of cases for whom treatment was judged to be effective and cases for whom treatment was judged to be ineffective multiplied by 100. Treatment success rate (T.S.R.) was calculated as number of cases for whom treatment was judged to be effective divided by sum of number of cases for whom treatment was judged to be effective, cases for whom treatment was judged to be ineffective and cases for whom the efficacy could not be assessed multiplied by 100.|Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI and FN Switched treatment)|The FAS population included all participants except those who did not meet main eligibility criteria, who did not receive ITCZ-IV or ITCZ-OS and participants without efficacy data. As per planned analysis both SFI (ITCZ Oral Solution Monotherapy) and SFI (Switched Treatment) arms were combined for all efficacy analyses.||percentage of participants||95% Confidence Interval|Number
780073|NCT00784368|Secondary|Number of Participants With Change in Clinical Symptoms by Diagnosis Name (Centralized Assessment)|Level of improvement in the clinical symptoms was assessed as: disappeared (if clinical symptoms disappeared), improved (significant improvement in clinical symptoms ), no change (almost no improvement in the clinical symptoms), worsened (if the clinical symptoms worsened) and could not be assessed (if it was difficult to make the above-noted assessments). The cases evaluated were candidemia, esophageal candidiasis, invasive aspergillosis, chronic necrotic pulmonary aspergillosis (C.N.P.A), pulmonary aspergilloma (P.A.) and pulmonary cryptococcosis (P.C).|Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI Switched treatment)|The FAS population. As per planned analysis both SFI arms were combined for efficacy analyses; participants with FN with suspected fungal infection were not planned to be analyzed for this outcome measure. Here, 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively.||participants|||Number
780074|NCT00784368|Secondary|Number of Participants With Change in Clinical Symptoms by Centralized Assessment|Level of improvement in the clinical symptoms was assessed as: disappeared (if clinical symptoms disappeared), improved (significant improvement in clinical symptoms ), no change (almost no improvement in the clinical symptoms), worsened (if the clinical symptoms worsened) and could not be assessed (if it was difficult to make the above-noted assessments).|Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI and FN Switched treatment)|FAS population included all participants except those who did not meet main eligibility criteria, who did not receive ITCZ-IV or ITCZ-OS and participants without efficacy data. As per planned analysis both SFI (ITCZ Oral Solution Monotherapy) and SFI (Switched Treatment) arms were combined for all efficacy analyses.||participants|||Number
780075|NCT00784368|Primary|Time Above Minimum Inhibitory Concentration (T>MIC)|The T>MIC was calculated only in participants for whom the MIC was obtained.|Day 85 for SFI (ITCZ Oral Solution Monotherapy); and Day 99 for SFI and FN Switched treatment|The PK analysis set. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively. MIC was not obtained for FN (Switched treatment) and hence the data not given for the same.||percent time||Standard Deviation|Mean
780076|NCT00784368|Primary|Area Under the Curve During 24 Hours by Minimum Inhibitory Concentration (AUC 0-24/MIC)|The AUC (0-24) is defined as area under the plasma concentration-time curve over the dosing interval (24 hr). It is usually calculated by linear trapezoidal method. MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. The AUC 0-24/MIC was calculated only in participants for whom the MIC was obtained.|Day 85 for SFI (ITCZ Oral Solution Monotherapy); and Day 99 for SFI and FN Switched treatment|The PK analysis set. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively. MIC was not obtained for FN (Switched treatment) and hence the data not given for the same.||hour||Standard Deviation|Mean
780077|NCT00784368|Primary|Maximum Plasma Drug Concentration by Minimum Inhibitory Concentration (Cmax/MIC)|The Cmax is maximum observed analyte concentration and MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. The Cmax/MIC was calculated only in participants for whom the MIC was obtained.|Day 85 for SFI (ITCZ Oral Solution Monotherapy); and Day 99 for SFI and FN Switched treatment|The PK analysis set. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively. MIC was not obtained for FN (Switched treatment) and hence the data not given for the same.||ratio||Standard Deviation|Mean
780078|NCT00784368|Primary|Minimum Inhibitory Concentration (MIC)|The MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation.|Day 85 for SFI (ITCZ Oral Solution Monotherapy); and Day 99 for SFI and FN Switched treatment|The PK analysis set. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively. MIC was not obtained for FN (Switched treatment) and hence the data not given for the same.||mcg per ml||Standard Deviation|Mean
793717|NCT00908583|Secondary|Number of Patients Whose Cytotoxic Panel Reactive Antibody (PRA) is Decreased by 50%|Number of patients on the waiting list whose cytotoxic PRA is decreased by 50%.|46 days|||participants|||Number
780079|NCT00784368|Primary|Area Under the Curve From Time Zero to 24 Hours Post-dose Observed Plasma Itraconazole Concentration (AUC[0-24])|The AUC(0-24) is area under the plasma concentration time curve from time zero (pre-dose) to 24 hours post-dose. It is usually calculated by linear trapezoidal method. AUC was measured in mcg*hour(hr) per ml.|Day 85 for SFI (ITCZ Oral Solution Monotherapy); and Day 99 for SFI and FN Switched treatment|The PK analysis set included all participants who received ITCZ-OS and had plasma concentration data. One participant without any infection evidence was also included in the PK population, for SFI (ITCZ-OS). Here 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively.||mcg*hr per ml||Standard Deviation|Mean
780080|NCT00784368|Primary|Maximum Plasma Itraconazole Concentration (Cmax)|The Cmax is defined as the maximum observed analyte concentration. Cmax was measured in microgram per milliliter (mcg/ml).|Day 85 for SFI (ITCZ Oral Solution Monotherapy); and Day 99 for SFI and FN Switched treatment|Pharmacokinetic (PK) analysis set included all participants who received ITCZ-OS and had plasma concentration data. One participant without any infection evidence was also included in the PK population for SFI (ITCZ-OS). 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively.||mcg/ml||Standard Deviation|Mean
780081|NCT00784459|Primary|Percentage of Eosinophils Recovered Following Segmental Allergen Challenge Following 3 Months of Placebo or Abatacept||3 months|||percentage of cells||Standard Deviation|Mean
780082|NCT00784459|Primary|Baseline Percentage of Eosinophils Recovered in the BAL Prior to Segmental Allergen Challenge|collected prior to randomization to abatacept or placebo|baseline|||percentage of cells||Standard Deviation|Mean
780083|NCT00784550|Secondary|Mean Change From Baseline in Scores on the Chronic Respiratory Disease Questionnaire-Self-Administered Standardized (CRQ-SAS) at Endpoint|The CRQ-SAS measures 4 domains of functioning of participants with COPD: mastery (amount of control the participant feels he/she has over COPD symptoms); fatigue (how tired the participant feels); emotional function (how anxious/depressed the participant feels); and dyspnea (how short of breath the participant feels during physical activities). Each domain is measured on a scale of 1-7 (1=maximum impairment; 7=no impairment). Each domain score is calculated separately.|Baseline and Endpoint (defined as the last recorded score [up to Week 24 or the early withdrawal visit] on each of the questions on this questionnaire)|ITT Population||points on a scale||Standard Error|Mean
780084|NCT00784550|Secondary|Mean Change From Baseline in AM (Morning, Approximately 6-9 AM) Pre-Dose Inspiratory Capacity (IC) at Endpoint|Change from baseline was calculated as the Endpoint (defined as the last recorded measure of AM pre-dose IC for each participant) value minus the baseline value. IC is defined as the amount of air that can be inhaled after a normal expiration. IC is a measure of pulmonary function.|Baseline and Endpoint (defined as the last recorded measure of AM pre-dose IC [up to Week 24] for each participant)|ITT Population||ml||Standard Error|Mean
780085|NCT00784550|Secondary|Mean Change From Baseline in 2 Hour Post-dose FVC at Endpoint|Change from baseline was calculated as the Endpoint (defined as the last recorded measure of 2 hour post-dose FVC for each participant) value minus the baseline value. FVC is defined as the amount of air that can forcibly be blown out after a full inspiration (FVC).|Baseline and Endpoint (defined as the last recorded measure of 2 hour post-dose FVC [up to Week 24] for each participant)|ITT Population||ml||Standard Error|Mean
780086|NCT00784550|Secondary|Mean Change From Baseline in AM (Morning, Approximately 6-9 AM) Pre-dose Forced Vital Capacity (FVC) at Endpoint|Change from baseline was calculated as the Endpoint (defined as the last recorded measure of AM pre-dose FVC fore each participant) value minus the baseline value. FVC is defined as the amount of air that can forcibly be blown out after a full inspiration.|Baseline and Endpoint (defined as the last recorded measure [up to Week 24] of AM pre-dose FVC for each participant)|ITT Population||ml||Standard Error|Mean
780087|NCT00784550|Secondary|Mean Change From Baseline in 2 Hour Post-dose FEV1 at Endpoint|Change from baseline was calculated as the Endpoint (defined as the last recorded measure of 2 hour post-dose FEV1 for each participant) value minus the baseline value. FEV1 is defined as the amount of air expelled from the lungs in one second after a full inspiration and is a measure of pulmonary function.|Baseline and Endpoint (defined as the last recorded measure [taken up to Week 24] of 2 hour post-dose FEV1 for each participant)|ITT Population||ml||Standard Error|Mean
780088|NCT00784550|Primary|Mean Change From Baseline in AM (Morning, Approximately 6-9 AM) Pre-dose Forced Expiratory Volume in One Second (FEV1) at Endpoint|Change from baseline was calculated as the Endpoint (defined as the last recorded measure of AM pre-dose FEV1 for each participant) value minus the baseline value. FEV1 is defined as the amount of air expelled from the lungs in one second after a full inspiration and is a measure of pulmonary function.|Baseline and Endpoint (defined as the last recorded measure [taken up to Week 24] of AM pre-dose FEV1 for each participant)|Intent-to-Treat (ITT) Population: all participants randomized to study drug||milliliters (ml)||Standard Error|Mean
780089|NCT00784563|Other Pre-specified|Change in LEDD (Levodopa Equivalent Daily Dose)|=amount after 6 months training - amount at baseline Total antiparkinsonian treatment daily dose expressed in levodopa equivalents per Tomlinson et al (PMID:21069833). Higher scores are worse.|6 months|||mg/day||Standard Deviation|Mean
780090|NCT00784563|Secondary|Change in Percent Increase Score (PIS) on Eriksen's Flanker Task|performance on the Eriksen's flanker task (see PMID: 24991037). Participants were asked to identify the orientation of a central arrow cue (‘<’ or ‘>’), which was flanked on both sides by two arrow cues that either pointed in the same direction (congruent: <<<<<) or a different direction (incongruent: >><>>). Using reaction times (RT) during congruent and incongruent trials, the PIS was calculated as =((RT_incongruent – RT_congruent) / RT_congruent) * 100. Higher PIS is worse.|6 months|||Percentage of Increase score||Standard Deviation|Mean
780091|NCT00784563|Secondary|Change in the MOCA Score|=Score after 6 months training - baseline score. MOCA=Montreal Cognitive Training Assessment Scores range 0-30, higher is better.|6 months|||units on a scale||Standard Deviation|Mean
780104|NCT00784654|Secondary|Change From Randomized Withdrawal Baseline in BPRS-C Total Score at Endpoint of The Randomized Withdrawal Period|The BPRS-C characterizes psychopathology. A total of 21 items are rated on a scale from 0 (not present) to 6 (extremely severe) with a total score ranging from 0 to 126. A decrease in score indicates a reduction in psychopathology.|Baseline of the randomized withdrawal period and its relevant endpoint (Up to 6 weeks)|Randomized Safety Population includes all subjects who received at least 1 dose of any investigational product during the Randomized Withdrawal Period||Scores on a scale||Standard Deviation|Mean
780092|NCT00784563|Secondary|Change in the Total UPDRS Score|"=Score after 6 months training - baseline score The total UPDRS score is calculated by adding Section I, Section II, and Section III scores (below). Higher scores are worse. The score ranges 0-176.
Unified Parkinson’s Disease Rating Scale (UPDRS) is an ordinal scale with all items scored from 0=normal function to 4=very severely disabled. It has 3 sections: I) Mental, Behavior, and Mood: Comprises four questions on intellectual impairment, thought disorder, depression, and apathy (scores range 0-16). II) The Activities of Daily Living (ADL) subscale is based on interview and comprises 13 items (scores range 0-52). III) UPDRS motor section is based on physical examination evaluates the components of parkinsonism (tremor, rigidity, bradykinesia, gait/posture). There are 27 items resulting in a maximum score of 108."|6 months|||units on a scale||Standard Deviation|Mean
780093|NCT00784563|Secondary|Change in the UPDRS Section III Score|=Score after 6 months training - baseline score Unified Parkinson’s Disease Rating Scale (UPDRS) is an ordinal scale with all items scored from 0=normal function to 4=very severely disabled. It has 3 sections: I) Mental, Behavior, and Mood: Comprises four questions on intellectual impairment, thought disorder, depression, and apathy (scores range 0-16). II) The Activities of Daily Living (ADL) subscale is based on interview and comprises 13 items (scores range 0-52). III) UPDRS motor section is based on physical examination evaluates the components of parkinsonism (tremor, rigidity, bradykinesia, gait/posture). There are 27 items resulting in a maximum score of 108. Higher scores are worse.|6 months|||units on a scale||Standard Deviation|Mean
780094|NCT00784563|Other Pre-specified|Change in Parkinson’s Disease Quality of Life Scale (PDQUALIF) Score|= PDQUALIF score after 6 months training - baseline score The PDQUALIF is a 32 item questionnaire resulting in 7 factors. . Subjects rate themselves between 1 (most favorable) and 5 (least favorable) on a Likert scale. Factor scores are standardized to100 and lower scores are better. The outcome measure is the average of these 7 factor scores.|6 months|||units on a scale||Standard Deviation|Mean
780095|NCT00784563|Other Pre-specified|Change in Geriatric Depression Scale Score|=Score after 6 months training - score at baseline. The Geriatric Depression Scale (GDS)-short form is a 15 item yes/no questionnaire. The range is 0-15 and scores >5 suggest depression. Higher scores are worse.|6 months|||units on a scale||Standard Deviation|Mean
780096|NCT00784563|Other Pre-specified|Change in Fatigue Severity Scale Score|=Score after 6 months of training - baseline score. The Fatigue Severity Scale (FSS) is a self-administered unidimensional generic 9-item fatigue rating scale. These are rated on a seven-grade Likert scale of which only the respective ends are defined (‘‘completely disagree’’=1 to ‘‘completely agree’’=7). The total FSS score represents the mean score of each of the nine items, yielding a score range between 1 and 7, higher scores indicating a higher level of fatigue.|6 months|||units on a scale||Standard Deviation|Mean
780097|NCT00784563|Secondary|Change in UPDRS Section II Score|=Score after 6 months training - baseline score Unified Parkinson’s Disease Rating Scale (UPDRS) is an ordinal scale with all items scored from 0=normal function to 4=very severely disabled. It has 3 sections: I) Mental, Behavior, and Mood: Comprises four questions on intellectual impairment, thought disorder, depression, and apathy (scores range 0-16). II) The Activities of Daily Living (ADL) subscale is based on interview and comprises 13 items (scores range 0-52). III) UPDRS motor section is based on physical examination evaluates the components of parkinsonism (tremor, rigidity, bradykinesia, gait/posture). There are 27 items resulting in a maximum score of 108. Higher scores are worse.|6 months|||units on a scale||Standard Deviation|Mean
780098|NCT00784563|Secondary|Change in the UPDRS Section I Score|=Score after 6 months training - baseline score Unified Parkinson’s Disease Rating Scale (UPDRS) is an ordinal scale with all items scored from 0=normal function to 4=very severely disabled. It has 3 sections: I) Mental, Behavior, and Mood: Comprises four questions on intellectual impairment, thought disorder, depression, and apathy (scores range 0-16). II) The Activities of Daily Living (ADL) subscale is based on interview and comprises 13 items (scores range 0-52). III) UPDRS motor section is based on physical examination evaluates the components of parkinsonism (tremor, rigidity, bradykinesia, gait/posture). There are 27 items resulting in a maximum score of 108. Higher scores are worse.|6 months|||units on a scale||Standard Deviation|Mean
780099|NCT00784563|Secondary|Change in 7 Meter Walk Time|Time complete the 7 m Walk test after 6 months aerobic training - Time complete the 7 m Walk test at baseline|6 months|See PMID: 24991037||seconds||Standard Deviation|Mean
780100|NCT00784563|Primary|Change in Aerobic Fitness|"VO2max after the training - VO2max at baseline (Adjusted for levodopa-equivalent, year, training mode, setting).
Please see publication PMID: 24991037 for details."|6 months|Because all treatment arms were designed to deliver a similar average aerobic intensity, we planned to pool a priori all completers from the Continuous and Interval Training Arms for all analyses.||ml/min/kg||Standard Deviation|Mean
780101|NCT00784654|Other Pre-specified|C-SSRS During the Randomized Withdrawal Period|C-SSRS is a semi-structured interview that captures the occurence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale.|Baseline of the randomized withdrawal period to end of the study (Up to 6 weeks)|Randomized Safety Population||participants|||Number
780102|NCT00784654|Other Pre-specified|Columbia-Suicide Severity Rating Scale (C-SSRS) During The Open-label Period|C-SSRS is a semi-structured interview that captures the occurence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale.|From open-label baseline to Week-26|Open-label Safety Population||participants|||Number
780103|NCT00784654|Other Pre-specified|Percent of Participants With CGI-S at Randomized Withdrawal Baseline|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|Randomized withdrawal baseline|Randomized FAS||percentage of participants|||Number
780161|NCT00784875|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Based on Insomnia Type|Number of participants with AEs and SAEs. Analyses were not performed by insomnia type (primary versus secondary) as originally planned because of insufficient number of secondary insomnia participants.|Baseline through 8 weeks|Analyses were not performed by insomnia type because of insufficient number of secondary insomnia patients. Zero participants were analyzed.||participants|||Number
780105|NCT00784654|Secondary|Change From Open-Label Baseline in The Brief Psychiatric Rating Scale for Children (BPRS-C) Total Score at Endpoint (Week-26) of The Open-label Period|The BPRS-C characterizes psychopathology. A total of 21 items are rated on a scale from 0 (not present) to 6 (extremely severe) with a total score ranging from 0 to 126. A decrease in score indicates a reduction in psychopathology.|At open-label baseline and endpoint (Week-26) of the open-label period|Open-label Safety Population includes all subjects who received at least 1 dose of investigational product in the Open-label period.||Scores on a scale||Standard Deviation|Mean
780106|NCT00784654|Secondary|Change From Randomized Withdrawal Baseline in The WFIRS-P Global Score at Endpoint of The Randomized Withdrawal Period|The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.|Baseline of the randomized withdrawal period and its relevant endpoint (Up to 6 weeks)|Randomized FAS||Scores on a scale||Standard Error|Least Squares Mean
780107|NCT00784654|Secondary|Change From Open-Label Baseline in The Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at Endpoint (Week-26) of The Open-label Period|The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.|At open-label baseline and endpoint (Week-26) of the open-label period|Open-label FAS||scores on a scale||Standard Deviation|Mean
780108|NCT00784654|Secondary|Change From Randomized Withdrawal Baseline in The CHIP-CE:PRF Global T-score at Endpoint of The Randomized Withdrawal Period|The CHIP-CE:PRF evaluates health-related quality of life. It is composed of 5 domains (satisfaction, comfort, resilience, avoidance, and achievement) consisting of a total of 76 items. The global score is an average of the scores for the 5 domains. The majority of items assess frequency of events using a 5-point response format. There is no range for a total score. Raw scale scores are used to generate T-scores. Higher scores indicate better health.|Baseline of the randomized withdrawal period and its relevant endpoint (Up to 6 weeks)|Randomized FAS||T-scores||Standard Error|Least Squares Mean
780109|NCT00784654|Secondary|Change From Open-label Baseline in The Child Health and Illness Profile, Child Edition: Parent Report Form (CHIP-CE:PRF) Global T-score at Endpoint (Week-26) of The Open-label Period|The CHIP-CE:PRF evaluates health-related quality of life. It is composed of 5 domains (satisfaction, comfort, resilience, avoidance, and achievement) consisting of a total of 76 items. The global score is an average of the scores for the 5 domains. The majority of items assess frequency of events using a 5-point response format. There is no range for a total score. Raw scale scores are used to generate T-scores. Higher scores indicate better health.|At open-label baseline and endpoint (Week-26) of the open-label period|Open-label FAS||T-scores||Standard Deviation|Mean
780110|NCT00784654|Secondary|Change From Randomized Withdrawal Baseline in The HUI-2 Scores at Endpoint of The Randomized Withdrawal Period|HUI is used to describe health status and to obtain utility scores by collecting data using one or more questionnaires in formats selected to match the specific study design criteria. Scoring ranges from 0.00 (dead) to 1.00 (perfect health). Higher scores represent better health status.|Baseline of the randomized withdrawal period and its relevant endpoint (Up to 6 weeks)|Randomized FAS||Scores on a scale||Standard Deviation|Mean
780111|NCT00784654|Secondary|Change From Open-label Baseline in The Health Utilities Index-2 (HUI-2) Scores at Endpoint (Week-26) of The Open-label Period, LOCF|HUI is used to describe health status and to obtain utility scores by collecting data using one or more questionnaires in formats selected to match the specific study design criteria. Scoring ranges from 0.00 (dead) to 1.00 (perfect health). Higher scores represent better health status.|At open-label baseline and endpoint (Week-26) of the open-label period|Open-label FAS||scores on a scale||Standard Deviation|Mean
780112|NCT00784654|Secondary|Percent of Participants With Improvement on Clinical Global Impression - Improvement (CGI-I) at Endpoint (Week-26) of The Open-label Period|"Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.
Improvement includes CGI-I categories of very much improved and much improved. No improvement includes all other assessed categories."|At Week 26|Open-label FAS||percentage of improved participants|||Number
780113|NCT00784654|Secondary|Percent of Participants With CGI-S at Endpoint of The Randomized Withdrawal Period, Last Observation Carried Forward (LOCF)|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|At endpoint of the randomized withdrawal period (Up to 6 weeks)|Randomized FAS||percentage of participants|||Number
780114|NCT00784654|Other Pre-specified|Percent of Participants With CGI-S at Open-label Baseline|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill).|Open-label baseline|Open-label FAS||percentage of participants|||Number
780115|NCT00784654|Secondary|Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Endpoint (Week-26) of The Open-label Period|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|At Week 26|Open-label FAS||percentage of participants|||Number
780116|NCT00784654|Secondary|Change From Randomized Withdrawal Baseline in The ADHD-RS-IV Total Score at Endpoint of The Randomized Withdrawal Period|ADHD-RS-IV consists of 18 items scored on a 4-point scale from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. A decrease in score indicates an improvement in ADHD symptomology.|Baseline of the randomized withdrawal period and its relevant endpoint (Up to 6 weeks)|Randomized FAS||Scores on a scale||Standard Error|Least Squares Mean
780117|NCT00784654|Secondary|Change From Open-Label Baseline in The Attention Deficit Hyperactivity Disorder Rating Scale-Fourth Edition (ADHD-RS-IV) Total Score at Endpoint (Week-26) of The Open-label Period|ADHD-RS-IV consists of 18 items scored on a 4-point scale from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. A decrease in score indicates an improvement in ADHD symptomology.|Open-label baseline and Endpoint (Week-26)|Open-label Full Analysis set (Open-label FAS) includes all subjects who received at least 1 dose of investigational product during the Open-label Period.||Scores on a scale||Standard Deviation|Mean
780619|NCT00789737|Secondary|% Subjects Achieving an HbA1C Goal of <7.0|% Subjects achieving an HbA1C goal of <7.0 at 24 weeks|24 weeks|Some participants may not have had lab results for this specific analysis and therefore excluded.||percentage of participants|||Number
780118|NCT00784654|Primary|Percent of Participants With Treatment Failures at End of The Randomized Withdrawal Period|"Treatment failure defined as 50% increase (worsening) in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) total score and >= 2 point increase (worsening) in the Clinical Global Impression-Severity of Illness (CGI-S) score observed at any visit during the randomized withdrawal period compared to the respective scores at baseline of randomized withdrawal period.
Subjects without an endpoint value were classed as treatment failures."|Baseline of the randomized withdrawal period and its relevant endpoint (Up to 6 weeks)|Randomized Full Analysis Set (Randomized FAS) includes all subjects who were randomized and received at least 1 dose of investigational product during the Randomized Withdrawal Period.||percentage of participants|||Number
780119|NCT00784719|Secondary|Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8|NEI-VFQ-25 questionnaire included 25 items based on which overall composite VFQ score and 12 subscales were derived: general health (GH), general vision (GV), ocular pain (OP), near activities (NAct), distance activities (DA), social functioning (SF), mental health (MH), role difficulties (RD), dependency, driving, color vision (CV) and peripheral vision (PV). Response to each question converted to 0-100 score. Each subscale, total score=average of items contributing to score. For each subscale and total score, score range: 0 to 100, higher score=less symptoms/better visual functioning.|Baseline, Week 8|ITT population included all enrolled participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.||Units on a scale||Standard Deviation|Mean
780120|NCT00784719|Secondary|Change From Baseline in Modified Ocular Comfort Index (mOCI) Raw Scores at Week 1, 2, 4, 6 and 8|mOCI consisted of the original 12-item OCI plus additional questions on other dry eye symptoms and their impact to participant's life. Each item was measured on a 7-point Likert scale ranging from 0 (never) to 6 (always/severe). Negative change from baseline indicated improvement.|Baseline, Week 1, 2, 4, 6, 8|Data for mOCI raw score was not analyzed due to the exploratory nature and overwhelming amount of data derived from the analysis.|||||
780121|NCT00784719|Secondary|Change From Baseline Ocular Surface Disease Index (OSDI) Raw Score at Week 1, 2, 4, 6 and 8|OSDI is a validated instrument for ocular surface disease. It has 12 items, each with a raw score measured on 5-point Likert scale (0=none of the time, 4=all the time).|Baseline, Week 1, 2, 4, 6, 8|Data for OSDI raw score was not analyzed due to the exploratory nature and overwhelming amount of data derived from the analysis.|||||
780122|NCT00784719|Secondary|Percentage of Participants With >= 10 Units Decrease in Total OSDI Score|OSDI is a validated instrument for ocular surface disease. It has 12 items, each has a raw score measured on 5-point Likert scale (0=none of the time, 4=all the time). Based on these item scores, a total OSDI score can be derived which ranges from 0 to 100; a higher score indicates worse ocular disease.|Week 1, 2, 4, 6, 8|ITT population included all enrolled participants who received at least 1 dose of study medication. LOCF method was used for imputing missing data at Week 8. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure.||percentage of participants|||Number
780123|NCT00784719|Secondary|Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8|OSDI is a validated instrument for ocular surface disease. It has 12 items, each measured on 5-point Likert scale (0=none of the time, 4=all the time). Based on these item scores, a total OSDI score (question 1 [Q1]-Q12) and three subscale scores can be derived: Ocular Symptom (Q1-Q3), Vision-related function (Q4-Q9), and Environmental trigger (Q10-Q12). Each derived score ranges from 0 to 100, with a higher score indicates worse condition.|Baseline, Week 1, 2, 4, 6, 8|ITT population. LOCF method was used for imputing missing data at Week 8. Here ‘N’ (number of participants analyzed) included those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.||units on a scale||Standard Deviation|Mean
780124|NCT00784719|Secondary|Change From Baseline in Daily Artificial Tear Use at Week 1, 2, 4, 6 and 8|Daily artificial tear use was assessed by collecting data on daily number of drops of artificial tear instilled in the eye using a participant diary. Decrease in daily artificial tear use indicated improvement.|Baseline, Week 1, 2, 4, 6, 8|ITT population. LOCF method was used for imputing missing data at Week 8. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.||drops/day||Standard Deviation|Mean
780125|NCT00784719|Secondary|Percentage of Participants With >= 5 Units Decrease in Total OCI Score|OCI: validated questionnaire to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point Likert scale ranging from 0 (never) to 6 (always/severe). Total score was transformed to range of 0 to 100, higher score indicated more ocular discomfort.|Week 1, 2, 4, 6, 8|ITT population included all enrolled participants who received at least 1 dose of study medication. LOCF method was used for imputing missing data at Week 8. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure.||percentage of participants|||Number
780126|NCT00784719|Secondary|Change From Baseline in Ocular Comfort Index (OCI) Score at Week 1, 2, 4, 6 and 8|OCI: validated questionnaire to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point Likert scale ranging from 0 (never) to 6 (always/severe). Total score was transformed to range of 0 to 100, higher score indicated more ocular discomfort. Negative change from baseline indicated improvement.|Baseline, Week 1, 2, 4, 6, 8|ITT population included all enrolled participants who received at least 1 dose of study medication. LOCF method was used for imputing missing data at Week 8. Here, 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.||units on a scale||Standard Deviation|Mean
780135|NCT00784719|Secondary|Time to Achieve >= 5 Units Decrease in Ocular Comfort Index (OCI) Score|OCI: validated questionnaire to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contained 12 questions, each measured on a 7-point Likert scale ranging from 0 (never) to 6 (always/severe). Total score was transformed to range of 0 to 100, higher score indicated more ocular discomfort. Negative change from baseline indicated improvement.|Baseline through Week 8|ITT population included all enrolled participants who received at least 1 dose of study medication.||days||95% Confidence Interval|Median
780127|NCT00784719|Secondary|Change From Baseline in Tear Break-up Time (TBUT) at Week 1, 2, 4, 6 and 8|TBUT was the time interval between the last complete blink and the first appearance of a dry spot, or disruption in the tear film. It was measured under a slit lamp following instillation of fluorescein dye in the eye using a stopwatch. Results from study eye are reported. Study eye is the ‘worse eye’, defined as the eye with worse Schirmer test score without anesthesia score at baseline.|Baseline, Week 1, 2, 4, 6, 8|ITT population included all enrolled participants who received at least 1 dose of study medication. LOCF method was used for imputing missing data at Week 8. 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.||seconds||Standard Deviation|Mean
780128|NCT00784719|Secondary|Change From Baseline in Interpalpebral Conjunctival Staining Score at Week 1, 2, 4, 6 and 8|Interpalpebral conjunctival staining was performed 1 minute following ocular administration of lissamine green dye with aid of slit lamp. Based on Oxford grading system, bulbar conjunctiva was divided into 2 zones: nasal, temporal. Staining were graded using a 6-point scale (0=absent, 5=severe). Total score=sum of 2 zone scores. Total score range: 0 to 10, higher score=higher damage to eyes due to dryness. Negative change from baseline indicated improvement. Results from study eye are reported. Study eye is the eye with worse Schirmer test score without anesthesia score at baseline.|Baseline, Week 1, 2, 4, 6, 8|ITT population. LOCF method was used for imputing missing data at Week 8. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.||units on a scale||Standard Deviation|Mean
780129|NCT00784719|Secondary|Percentage of Participants Who Demonstrated 100% Clearance of Corneal Staining|Corneal staining was assessed using fluorescein dye, yellow filter, slit lamp. Cornea was divided into 5 different zones. Each corneal zone was graded independently using 0 to 3 grading scale:0=none, 1=slight, 2=moderate, 3=severe. Sum of scores of each zone led to total score. Total score range: 0 to 15, higher score indicated greater staining. Results from study eye are reported. Study eye is the ‘worse eye’, defined as the eye with worse Schirmer test score without anesthesia score at baseline.|Week 1, 2, 4, 6, 8|ITT population included all enrolled participants who received at least 1 dose of study medication. LOCF method was used for imputing missing data at Week 8. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure.||percentage of participants|||Number
780130|NCT00784719|Secondary|Change From Baseline in Corneal Staining Scores at Week 1, 2, 4, 6 and 8|Corneal staining was assessed using fluorescein dye, a yellow filter, and a slit lamp. The cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale; where 0=none, 1=slight, 2=moderate, 3=severe. Sum of scores of each zone led to total score. Total score range: 0 to 15, higher score indicated greater staining. Results from study eye are reported. Study eye is the ‘worse eye’, defined as the eye with worse Schirmer test score without anesthesia score at baseline.|Baseline, Week 1, 2, 4, 6, 8|ITT population included all enrolled participants who received at least 1 dose of study medication. LOCF method was used for imputing missing data at Week 8. Here, 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.||units on a scale||Standard Deviation|Mean
780131|NCT00784719|Secondary|Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score With Anesthesia at Week 8|Schirmer test was performed 2 to 3 minutes after 1 drop of proparacaine 0.5% was placed in lower conjunctival fornix and superior bulbar conjunctiva of each eye. It was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the ‘worse eye’, defined as the eye with worse Schirmer test score without anesthesia score at baseline.|Week 8|ITT population included all enrolled participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure.||percentage of participants|||Number
780132|NCT00784719|Secondary|Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4 and 6|Schirmer test without anesthesia: well standardized test used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the ‘worse eye’, defined as the eye with worse Schirmer test score without anesthesia score at baseline.|Week 1, 2, 4, 6|ITT population included all enrolled participants who received at least 1 dose of study medication. Here 'N' (number of participants analyzed) included those participants who were evaluable for this measure.||percentage of participants|||Number
780133|NCT00784719|Secondary|Change From Baseline in Schirmer Wetting Score With Anesthesia at Week 8|Schirmer test was performed 2 to 3 minutes after 1 drop of proparacaine 0.5% was placed in lower conjunctival fornix and superior bulbar conjunctiva of each eye. It was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the ‘worse eye’, defined as the eye with worse Schirmer test score without anesthesia score at baseline.|Baseline, Week 8|ITT population included all enrolled participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.||mm||Standard Deviation|Mean
780134|NCT00784719|Secondary|Change From Baseline in Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4, 6 and 8|Schirmer test without anesthesia: well standardized test used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the ‘worse eye’, defined as the eye with worse Schirmer test score without anesthesia score at baseline.|Baseline, Week 1, 2, 4, 6, 8|ITT population included all enrolled participants who received at least 1 dose of study medication. LOCF method was used for imputing missing data at Week 8. Here, 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.||mm||Standard Deviation|Mean
794878|NCT00920647|Primary|Safety: Development of Anti-idursulfase Antibodies (CSF)|Reflects development of anti-idursulfase antibodies post baseline.|6 months|Abnormalities Any Time Post-baseline ITT Population||participants|||Number
780136|NCT00784719|Secondary|Time to Achieve 100 Percent (%) Clearance of Corneal Staining|Corneal staining was assessed by instilling sodium fluorescein dye in the eye and after 1 to 2 minutes, observing for corneal staining with the aid of a yellow filter and slit lamp. The cornea was divided into five different zones and each corneal zone was graded independently using a 0 to 3 grading scale; where 0=none, 1=slight, 2=moderate, 3=severe. Results from study eye were to be reported. Study eye is the ‘worse eye’, defined as the eye with worse Schirmer test score without anesthesia score at baseline.|Baseline through Week 8|ITT population included all enrolled participants who received at least 1 dose of study medication.||days||95% Confidence Interval|Median
780137|NCT00784719|Secondary|Time to Achieve >= 10mm Schirmer Test Score Without Anesthesia|Schirmer test without anesthesia: well standardized test used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the ‘worse eye’, defined as the eye with worse Schirmer test score without anesthesia score at baseline.|Baseline through Week 8|ITT population included all enrolled participants who received at least 1 dose of study medication.||days||95% Confidence Interval|Median
780138|NCT00784719|Primary|Percentage of Participants Who Achieved Greater Than or Equal to (>=) 10 Millimeter (mm) Schirmer Wetting Score Without Anesthesia at Week 8|Schirmer test without anesthesia: well standardized test used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 millimeter (mm). If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the ‘worse eye’, defined as the eye with worse Schirmer test score without anesthesia score at baseline.|Week 8|ITT population included all enrolled participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) was the method used for imputing missing data at Week 8.||percentage of participants|||Number
780139|NCT00784719|Primary|Percentage of Participants With Ocular Tolerability Assessment|Ocular tolerability assessment included evaluation of severity and duration of the 5 symptoms: burning/stinging, blurred vision, ocular discomfort, pain, tearing. Severity was assessed on a 4-point scale, where 0=none, 1=mild, 2=moderate and 3=severe. Duration was assessed as immediate (if subsided within 5 minutes [<5 min] after application) or persistent (if continued beyond 5 minutes [>=5 min] after application).|Baseline up to Week 8|ITT population included all enrolled participants who received at least one dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||percentage of participants|||Number
780140|NCT00784719|Primary|Percentage of Participants With Ocular Adverse Events (AEs)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Ocular AEs are the events which are localized in the ocular region.|Baseline up to Week 8|ITT population included all enrolled participants who received at least 1 dose of study medication.||percentage of participants|||Number
780141|NCT00784719|Primary|Percentage of Participants With Systemic Adverse Events (AEs)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Systemic AEs are the events which are not localized but occur throughout the systemic circulation.|Baseline up to Week 8|Intent-to-treat (ITT) population included all enrolled participants who received at least 1 dose of study medication.||percentage of participants|||Number
780142|NCT00784784|Primary|Number of Laboratory Confirmed Influenza Infections|Four-fold increase in antibody titer 2 weeks post injection and end of study or positive laboratory test for influenza during study (polymerase chain reaction [PCR] or culture)|6 months|intention to treat||infections|||Number
780143|NCT00784784|Secondary|Number of Subjects Adhering to Long-term Zanamivir Prophylaxis|Number of subjects taking 80% or more doses per week of zanamivir (10 mg once daily), as influenza prophylaxis, for 13 weeks or longer (as measured by weekly diary and dose counts at study visits).|5 months|ITT||participants||95% Confidence Interval|Number
780144|NCT00784810|Secondary|Number of Intakes of Rescue Medication (Ibuprofen) Between Visit 8 and Visit 9 for the 2 Groups.|"To compare the number of intakes of rescue medication use (ibuprofen) for breakthrough pain between OXN (Oxycodone/Naloxone) and codeine/paracetamol groups. Ibuprofen tablets (400mg up to 3 times per day) were available as rescue medication. This was recorded by the subject in their diary whenever it was taken. The discrepancy in numbers of patients at this stage (between Visit 8 and Visit 9) is due to subject withdrawal during the study. The mean values presented are the number of intakes of rescue medication for this period (ie between Visit 8 and Visit 9)."|Between visit 8 and 9|The number of participants for analysis is less due to subject withdrawals or lack of data.||Number of rescue medication intakes||Standard Deviation|Mean
780145|NCT00784810|Primary|Average Daily Pain Score Box Scale-11 (BS-11) Recorded at Week 12 (Average Pain Over Last 24 Hours)|The primary objective was to demonstrate non inferiority of Oxycodone/Naloxone Prolonged Release (OXN PR) compared to codeine/paracetamol in moderate to severe pain as assessed by BS-11 average daily pain scores. The Box Scale-11 is a scale from 0 to 10 (i.e. 0, 1, 2...10), where the subject records their daily pain over the previous 24 hours, by circling the relevant box, where 0 = no pain and 10 = pain as bad as you can imagine. This value is the value recorded at week 12 (average pain over the last 24 hours)|Average daily pain over last 24 hours (at Week 12)|To achieve a study with 80% power at the 1-sided 5% sig level and define non-inferiority to be a relative different less than 1.2. A sample size of 98 subjects per treatment group was required, ie a total of 196 subjects completing the study. The lower number of participants is due to subject withdrawal or lack of data.||Units on a BS-11 scale at Week 12||Standard Deviation|Mean
780160|NCT00784875|Secondary|Change From Baseline in Total Sleep Time at Week 4 (Week 2 of Period B) Endpoint Based on Age Group|Total Sleep Time is defined as time in bed minus total time awake. Minimum would be 0; no defined maximum (except if as defined as time in bed). The higher the number, the more time asleep. Analyses were not performed by age group (under age 65 versus over age 65) as originally planned because of insufficient number of elderly participants.|Baseline, 2 weeks|Analyses were not performed by age group because of insufficient number of elderly patients. Zero participants were analyzed.||minutes||Standard Error|Least Squares Mean
780146|NCT00784836|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: any untoward medical occurrence in a participant that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product, whether or not related to the investigational product. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect. An SAE may also be any other medically important event that, in the opinion of the investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above.|Planned for up to 18 months plus 30 days; actual study duration was 111 days.|||participants|||Number
780147|NCT00784836|Primary|Number of Participants Who Developed Neutralizing Antibodies (NAbs) to Interferon-beta (IFN-beta)|The presence of antibodies to IFN-beta in human serum, determined using a tiered approach involving a screening Enzyme-Linked ImmunoSorbent Assay (ELISA) to detect binding antibodies (BAbs). Positive samples characterized and titrated in a cell-based neutralizing antibody (NAb) assay.|assessed every 3 months up to 18 months|The study was terminated early before any of the 3 enrolled subjects completed the study; therefore, no statistical analysis was performed.|||||
780148|NCT00784849|Secondary|Superficial Skin Necrosis|the number of participants who developed post-operative skin necrosis within 2 weeks of surgery|2 weeks postoperatively|||participants|||Number
780149|NCT00784849|Secondary|Safety (Allergic Reaction to Blue Dye)|number of participants who had a systemic allergic reaction such as hives, shortness of breath, hypotension|intraoperatively up to 6 hours|||participants|||Number
780150|NCT00784849|Primary|The Number of Participants That Have Sentinel Nodes Which Are Radioactive or Blue, or Radioactive and Blue or Have Efferent Blue Lymphatics Leading up to the Sentinel Node(s)||intraoperatively; up to 6 hours|||participants|||Number
780151|NCT00784875|Secondary|Change From Baseline in QT Interval Corrected Using Fridericia Formula (QTcF) as Measured by Electrocardiogram (ECG) at Each 2-week Treatment Endpoint|QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. QTcF is the QT interval corrected for heart rate using Fridericia formula. Least Squares Mean (LSMean) values were adjusted for baseline and treatment.|Baseline, 2 weeks of treatment over 8 weeks|All randomized Cohort 1 and 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.||milliseconds||Standard Error|Least Squares Mean
780152|NCT00784875|Secondary|Change From Baseline in Heart Rate as Measured by Electrocardiogram (ECG) at Each 2-week Treatment Endpoint|Change from baseline to the end of each of the 2-week treatment periods (Periods B, C, and D) for heart rate are presented. Least Squares Mean (LSMean) values were adjusted for baseline and treatment.|Baseline, 2 weeks of treatment over 8 weeks|All randomized Cohort 1 and 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.||beats per minute||Standard Error|Least Squares Mean
780153|NCT00784875|Secondary|Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint|Summary of number of participants with abnormal clinical chemistry, hematology and urinalysis laboratory results. A participant is included in the abnormal category if he/she experienced a result outside the normal reference ranges based on Lilly's reference range in the current period. All analytes have both lower and upper limits. The abnormal number includes both low (below normal range) and high (above normal range).|2 weeks of treatment over 8 weeks|All randomized Cohorts 1 and 2 participants who received at least one dose of study drug, and had endpoint value. For LY2624803 1 mg, LY2624803 3 mg, Zolpidem 5 or 10 mg, and Placebo, the Number of Participants Analyzed were as follows: Period B: N=114, 113,117, 117; Period C: N=103, 97, 97, 98; and Period D: N=91, 89, 94, 88.||participants|||Number
780154|NCT00784875|Secondary|Change From Baseline in Weight at Each 2-week Treatment Endpoint|Change from baseline to the end of each of the 2-week treatment periods (Periods B, C, and D) for body weight are presented. Least Squares Mean (LSMean) values were adjusted for baseline and treatment.|Baseline, 2 weeks of treatment over 8 weeks|All randomized Cohorts 1 and 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.||kilogram||Standard Error|Least Squares Mean
780155|NCT00784875|Secondary|Change From Baseline in Pulse Rate at Each 2-week Treatment Endpoint|Change from baseline to the end of each of the 2-week treatment periods (Periods B, C, and D) for pulse rate are presented. Least Squares Mean (LSMean) values were adjusted for baseline and treatment.|Baseline, 2 weeks of treatment over 8 weeks|All randomized Cohorts 1 and 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.||beats per minute||Standard Error|Least Squares Mean
780156|NCT00784875|Secondary|Change From Baseline in Blood Pressure (BP) at Each 2-Week Treatment Endpoint|Change from baseline to the end of each of the 2-week treatment periods (Periods B, C, and D) for systolic blood pressure (SBP) and diastolic blood pressure (DBP) are presented. Least Squares Mean (LSMean) values were adjusted for baseline and treatment.|Baseline, 2 weeks of treatment over 8 weeks|All randomized Cohorts 1 and 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.||mmHg||Standard Error|Least Squares Mean
780157|NCT00784875|Secondary|Number of Participants With Serious Adverse Events (SAEs)|SAEs do not distinguish whether the events are treatment-emergent. A summary of SAEs is located in the Reported Adverse Event module.|Baseline through 8 weeks|All randomized Cohorts 1 and 2 participants who received at least one dose of study drug.||participants|||Number
780158|NCT00784875|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAE)|Treatment Emergent Adverse Events (TEAEs) are defined as AEs that first occurred or worsened during the treatment period. TEAEs are summarized by study period and treatment group. TEAEs do not distinguish whether the events were deemed serious. A summary of non-serious AEs is located in the Reported Adverse Event module.|Baseline through 8 weeks|All randomized Cohorts 1 and 2 participants who received at least one dose of study drug.||participants|||Number
780159|NCT00784875|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Based on Age Group|Number of participants with AEs and SAEs. Analyses were not performed by age group (under age 65 versus over age 65) as originally planned because of insufficient number of elderly participants.|Baseline through 8 weeks|Analyses were not performed by age group because of insufficient number of elderly patients. Zero participants were analyzed.||participants||Standard Error|Least Squares Mean
780162|NCT00784875|Secondary|Change From Baseline in Total Sleep Time at Week 4 (Week 2 of Period B) Endpoint Based on Insomnia Type|Total Sleep Time is defined as time in bed minus total time awake. Minimum would be 0; no defined maximum (except if as defined as time in bed). The higher the number, the more time asleep. Analyses were not performed by insomnia type (primary versus secondary) as originally planned because of insufficient number of secondary insomnia participants.|Baseline, 2 weeks|Analyses were not performed by insomnia type because of insufficient number of secondary insomnia patients. Zero participants were analyzed.||minutes||Standard Error|Least Squares Mean
780163|NCT00784875|Secondary|Patient Global Impression of Improvement (PGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint|A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much improved) to 7 (very much worse). Data are presented as percentage of participants in each category.|2 weeks|All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.||percentage of participants|||Number
780164|NCT00784875|Secondary|Clinical Global Impression of Improvement (CGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint|Measures clinician's perception of participant improvement at the time of assessment compared with the start of treatment. Scores range from 1 (very much improved) to 7 (very much worse). Data are presented as percentage of participants in each category.|2 weeks|All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.||percentage of participants|||Number
780165|NCT00784875|Secondary|Treatment Satisfaction as Measured by the Participant Drug Preference Question|After study Periods A, and B, participants were asked to rate their experience with the treatment they had just completed. Data are presented as percentage of participants preferring the treatment received in Period A (placebo) or treatment received in Period B.|Baseline (Period A) and 2 weeks (Period B)|All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.||percentage of participants|||Number
780166|NCT00784875|Secondary|Change From Baseline in Health-related Quality of Life as Measured by European Quality of Life (EuroQol) at Week 4 (Week 2 of Period B) Endpoint|The EuroQoL Questionnaire–5 Dimension (EQ-5D) is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. The score ranges 0-100. The higher score indicates a better health state perceived by the participant. ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).|Baseline, 2 weeks|All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.||units on a scale||Standard Error|Least Squares Mean
780167|NCT00784875|Secondary|Change From Baseline in Physical and Mental Component Scores as Measured by the Short Form 12 (SF-12) Version 2 at Week 4 (Week 2 of Period B) Endpoint|The SF-12 is a subset of 12 items from the Medical Outcomes Study 36-Item Short Form Survey (SF-36) and was collected at the bi-weekly office visits. Each score ranges from 0-100. The components measure physical and mental health, respectively. Higher scores are indicative of better function. ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary)|Baseline, 2 weeks|All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.||units on a scale||Standard Error|Least Squares Mean
780168|NCT00784875|Secondary|Change From Baseline in the Insomnia Severity Index (ISI) at Week 4 (Week 2 of Period B) Endpoint|The ISI is a brief self-report instrument that measures a participant’s perception of his or her insomnia. 7 questions on 5-point Likert scale with minimum of 0 and maximum of 28. The higher the score, the more severe the insomnia. It was collected at the bi-weekly office visits. ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).|Baseline, 2 weeks|All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.||units on a scale||Standard Error|Least Squares Mean
780169|NCT00784875|Secondary|Change From Baseline in Participants' Impression of Daytime Functioning Measured by Daily Consequences of Insomnia Questionnaire (DCIQ) at Week 4 (Week 2 of Period B) Endpoint|DCIQ scale is asked in the participant-reported daily evening questionnaire; 5 point Likert scale with minimum of 0 and maximum of 44 (the higher the score, the more consequences of insomnia). Scale is averaged across study Period B (2 weeks). Change score subtracts Period B average from Period A average (baseline). ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).|Baseline, 2 weeks|All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.||units on a scale||Standard Error|Least Squares Mean
780170|NCT00784875|Secondary|Change From Baseline in Assessment of Sleep Quality at Week 4 (Week 2 of Period B) Endpoint|Assessment of Sleep Quality (ASQ) scale is asked in the participant-reported daily sleep questionnaire; 8 items on 4 point Likert scale with a range of 0 to 24. Sleep experience score ranges from 0-9; awakening experience ranges from 0-15. The higher the score, the better the sleep. Scale is averaged across study Period B (2 weeks). Change score subtracts Period B average from Period A average (baseline). ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).|Baseline, 2 weeks|All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.||units on a scale||Standard Error|Least Squares Mean
780171|NCT00784875|Secondary|Change From Baseline in Sleep Efficiency at Week 4 (Week 2 of Period B) Endpoint|Calculated as (TIB-TTA)/TIB where TIB is time in bed and TTA is total unwanted time awake. Higher score indicates better sleep efficiency. ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).|Baseline, 2 weeks|All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.||ratio||Standard Error|Least Squares Mean
780647|NCT00789815|Secondary|The Recovery Time to Ambulation|The recovery time to ambulation defined as the time between finishing flexible bronchoscopy to the moment when patients could walk without assistance.|After the bronchoscopy|||Minutes||Standard Deviation|Mean
780172|NCT00784875|Secondary|Change From Baseline in Total Time Awake at Week 4 (Week 2 of Period B) Endpoint|Calculated in minutes from participant-reported daily sleep questionnaire averaged across study Period B (2 weeks). Change score subtracts Period B average from Period A average (baseline). ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).|Baseline, 2 weeks|All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.||minutes||Standard Error|Least Squares Mean
780173|NCT00784875|Secondary|Change From Baseline in Number of Awakenings During Sleep at Week 4 (Week 2 of Period B) Endpoint|Elicited from participant-reported daily sleep questionnaire averaged across study Period B (2 weeks). Change score subtracts Period B average from Period A average (baseline). ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).|Baseline, 2 weeks|All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.||number of awakenings||Standard Error|Least Squares Mean
780174|NCT00784875|Secondary|Change From Baseline in Unwanted Time Awake at Week 4 (Week 2 of Period B) Endpoint|Unwanted time awake (minutes awake [MA] before sleep [between turning off the lights to first falling asleep], MA during sleep, MA after sleep before getting out of bed). Minimum would be 0; no defined maximum. The higher the number, the more the unwanted time awake. Calculated in minutes from participant-reported daily sleep questionnaire averaged (Avg.) across Period B. Change score subtracts Period B Avg. from Period A Avg. (baseline). ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group, and insomnia type.|Baseline, 2 weeks|All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.||minutes||Standard Error|Least Squares Mean
780175|NCT00784875|Primary|Change From Baseline in Average Nightly Total Sleep Time at Week 4 (Week 2 of Period B) Endpoint|Total Sleep Time is defined as time in bed minus total time awake. Minimum would be 0; no defined maximum (except if as defined as time in bed). The higher the number, the more time asleep. Calculated in minutes from participant-reported daily sleep questionnaire averaged across study Period B (2 weeks). Change score subtracts Period B average from Period A average (baseline). Analysis of covariance (ANCOVA) Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).|Baseline, 2 weeks|All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.||minutes||Standard Error|Least Squares Mean
780176|NCT00784927|Secondary|Time to Treatment Failure|Time to treatment failure is defined to be the time from registration to the date at which the patient is removed from treatment due to progression, adverse events, or refusal. The distribution of time to treatment failure will be estimated using the method of Kaplan-Meier.|Up to 1 year from registration.|||months||95% Confidence Interval|Median
780177|NCT00784927|Secondary|Progression-free Survival Time|"Progression-free survival time is defined as the time from registration to the earliest date of documentation of disease progression. If a patient dies without a documentation of disease progression the patient will be considered to have had disease progression at the time of their death.
Progressive disease is defined as having one of the following:
The appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size.
At least a 50% increase from nadir in the sum of the product of the dimension (SPD) of any previously involved nodes.
At least a 50% increase in the longest diameter of any single previously identified node more than 1 cm in its short axis."|Up to 1 year from registration.|||months||95% Confidence Interval|Median
780178|NCT00784927|Secondary|Survival Time|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.|Up to 1 year from registration.|||months||95% Confidence Interval|Median
780179|NCT00784927|Secondary|Tumor Response to Lenalidomide, Rituximab, Cyclophosphamide and Dexamethasone in the Subgroup of Patients With Lymphoplasmacytic Lymphoma (Waldenstrom’s Macroglobulinemia).|"The proportion of responses in Waldenstrom's macroglobulinemia was determined by counting the number of complete responses and partial responses and dividing by the number of evaluable patients.
Complete Response (CR): Disappearance of all evidence of disease and disease-related symptoms. The spleen and/or liver, if considered enlarged before therapy on the basis of a physical examination or CT scan, should not be palpable on physical examination and should be considered normal size by imaging studies, and nodules related to lymphoma should disappear. If the bone marrow was involved by lymphoma before treatment, the infiltrate must have cleared on repeat bone marrow biopsy.
Partial Response (PR): At least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses. No increase should be observed in the size of other nodes, liver, or spleen. No new sites of disease should be observed."|Up to 1 year from registration.|||percentage of participants||95% Confidence Interval|Number
780180|NCT00784927|Primary|Assessment of Tumor Response|"The proportion of responses was determined by counting the number of complete responses and partial responses and dividing by the number of evaluable patients.
Complete Response (CR): Disappearance of all evidence of disease and disease-related symptoms. The spleen and/or liver, if considered enlarged before therapy on the basis of a physical examination or CT scan, should not be palpable on physical examination and should be considered normal size by imaging studies, and nodules related to lymphoma should disappear. If the bone marrow was involved by lymphoma before treatment, the infiltrate must have cleared on repeat bone marrow biopsy.
Partial Response (PR): At least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses. No increase should be observed in the size of other nodes, liver, or spleen. No new sites of disease should be observed."|Up to 1 year from registration.|||percentage of participants||95% Confidence Interval|Number
780181|NCT00784979|Secondary|Monitor Patient Survival||5 years||||||
780182|NCT00784979|Secondary|Monitor Graft Survival||5 years||||||
780208|NCT00794118|Primary|Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 9|Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual’s own proteins) that are frequently detected in the blood of rheumatoid arthritis participants. Anti-CCP antibodies value higher than 10 U/mL is considered positive.|Month 9|ITT population included all participants who received at least 1 dose of the study medication.||Participants|||Number
780183|NCT00784979|Primary|The Percent of Sensitized Patients Treated With PRA Reduction Pharmacological Therapy, Including Cytogam, Who Become Cross-match Compatible With Potential Living Donor|The percent of sensitized patients treated with PRA Reduction Pharmacological Therapy, including Cytogam, who become cross-match compatible with potential living donor. Treatment success defined as achieving a decrease in donor specific antibody and eliminating cross-match incompatibility sufficient to allow transplantation.|four weeks|||percent of subjects becoming compatible|||Number
780184|NCT00785044|Primary|Numerical Heart to Mediastinum (H/M) Ratio at 3 Hours 50 Minutes Post-administration on Planar 123I-mIBG Imaging by Adverse Cardiac Events (ACEs) Status|The numerical value of 123 I-mIBG uptake (H/M ratio) at 3 hours 50 minutes post administration was calculated by dividing the counts/pixel in the total myocardium region of interest (ROI) by the counts/pixel in the 7x7 pixel mediastinal ROI. Receiver operator characteristic curves (ROC) constructed on the basis of sensitivity and specificity to identify ACEs across all H/M values were used to calculate the area under the ROC curve (AUC). The AUC was used to test for statistical significance of the prognostic usefulness of the H/M ratio. In the present MBG313 study, additional efficacy data is provided for 471 participants and new data from MBG313 were combined with data collected in MBG311 and MBG312 for efficacy analysis.|From the date of administration of 123I-mIBG in studies MBG-311 or MBG-312 up to 24 months|Efficacy population was 961 participants who received IMP and had a consensus H/M ratio on 3 hour 50 minute planar image in MBG 311 or MBG 312. Here, number of participant analyzed = number of participants with available data for this endpoint.||Ratio||Standard Deviation|Mean
780185|NCT00785213|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. [AUC(0-∞)] was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant for rosiglitazone.|serial pharmacokinetic blood samples drawn prior to dosing on Days 1 and 7 and then 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 20 and 24 hours after dose administration.|Twenty Three (23) subjects were enrolled in this study. Five (5) subjects withdrew from the study. Pharmacokinetic analyses are based upon data obtained from the eighteen (18) subjects that completed the study.||ug-hr/mL||Standard Deviation|Mean
780186|NCT00785213|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule for rosiglitazone.|serial pharmacokinetic blood samples drawn prior to dosing on Days 1 and 7 and then 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 20 and 24 hours after dose administration.|Twenty Three (23) subjects were enrolled in this study. Five (5) subjects withdrew from the study. Pharmacokinetic analyses are based upon data obtained from the eighteen (18) subjects that completed the study.||ug-hr/mL||Standard Deviation|Mean
780187|NCT00785213|Primary|Maximum Plasma Concentration (Cmax) of Rosiglitazone|The maximum or peak concentration that rosiglitazone reaches in the plasma.|serial pharmacokinetic blood samples drawn prior to dosing on Days 1 and 7 and then 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 20 and 24 hours after dose administration.|Twenty Three (23) subjects were enrolled in this study. Five (5) subjects withdrew from the study. Pharmacokinetic analyses are based upon data obtained from the eighteen (18) subjects that completed the study.||ug/mL||Standard Deviation|Mean
780188|NCT00794118|Secondary|Indirect Costs|Indirect costs represent the loss of resources as a consequence of work disability or unemployment.|Baseline, Months 3, 6, 9 and 12||08/2012||||
780189|NCT00794118|Secondary|Direct Costs|Direct costs included all expenses requiring actual payment or time spent due to the disease itself or to disability.|Baseline, Months 3, 6, 9 and 12||08/2012||||
780190|NCT00794118|Primary|36-Item Short-Form Health Survey (SF-36) at Month 12|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Month 12|ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.||Units on a Scale||Standard Deviation|Mean
780191|NCT00794118|Primary|Stanford Health Assessment Questionnaire (HAQ) Score at Month 12|HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. The higher score reported by the participant for any component question of the 8 categories determines the score for that categories. Total score is divided for 8. Average score range: 0 (no difficulty) to 3 (unable to do).|Month 12|ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.||Units on a Scale||Standard Deviation|Mean
780192|NCT00794118|Primary|Stanford Health Assessment Questionnaire (HAQ) Score at Month 9|HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. The higher score reported by the participant for any component question of the 8 categories determines the score for that categories. Total score is divided for 8. Average score range: 0 (no difficulty) to 3 (unable to do).|Month 9|ITT population included all participants who received at least 1 dose of the study medication.||Units on a Scale||Standard Deviation|Mean
780193|NCT00794118|Primary|Stanford Health Assessment Questionnaire (HAQ) Score at Month 6|HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. The higher score reported by the participant for any component question of the 8 categories determines the score for that categories. Total score is divided for 8. Average score range: 0 (no difficulty) to 3 (unable to do).|Month 6|ITT population included all participants who received at least 1 dose of the study medication.||Units on a Scale||Standard Deviation|Mean
780194|NCT00794118|Primary|Stanford Health Assessment Questionnaire (HAQ) Score at Month 3|HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. The higher score reported by the participant for any component question of the 8 categories determines the score for that categories. Total score is divided for 8. Average score range: 0 (no difficulty) to 3 (unable to do).|Month 3|ITT population included all participants who received at least 1 dose of the study medication.||Units on a Scale||Standard Deviation|Mean
780195|NCT00794118|Primary|Duration of Morning Stiffness at Month 12|Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Month 12|ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.||minutes||Standard Deviation|Mean
780196|NCT00794118|Primary|Duration of Morning Stiffness at Month 9|Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Month 9|ITT population included all participants who received at least 1 dose of the study medication.||minutes||Standard Deviation|Mean
780197|NCT00794118|Primary|Duration of Morning Stiffness at Month 6|Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Month 6|ITT population included all participants who received at least 1 dose of the study medication.||minutes||Standard Deviation|Mean
780198|NCT00794118|Primary|Duration of Morning Stiffness at Month 3|Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Month 3|ITT population included all participants who received at least 1 dose of the study medication.||minutes||Standard Deviation|Mean
780199|NCT00794118|Primary|Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 12|Anti-DNA antibodies are auto antibodies directed against DNA and are present in higher than normal numbers in autoimmune disease. Anti-DNA antibodies value higher than 1:20 is considered positive.|Month 12|ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.||Participants|||Number
780200|NCT00794118|Primary|Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 9|Anti-DNA antibodies are auto antibodies directed against DNA and are present in higher than normal numbers in autoimmune disease. Anti-DNA antibodies value higher than 1:20 is considered positive.|Month 9|ITT population included all participants who received at least 1 dose of the study medication.||Participants|||Number
780201|NCT00794118|Primary|Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 6|Anti-DNA antibodies are auto antibodies directed against DNA and are present in higher than normal numbers in autoimmune disease. Anti-DNA antibodies value higher than 1:20 is considered positive.|Month 6|ITT population included all participants who received at least 1 dose of the study medication.||Participants|||Number
780202|NCT00794118|Primary|Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 3|Anti-DNA antibodies are auto antibodies directed against DNA and are present in higher than normal numbers in autoimmune disease. Anti-DNA antibodies value higher than 1:20 is considered positive.|Month 3|ITT population included all participants who received at least 1 dose of the study medication.||Participants|||Number
780203|NCT00794118|Primary|Number of Participants With Anti-nuclear Antibodies at Month 12|Anti-nuclear antibodies are auto antibodies directed against contents of the nucleus and are present in higher than normal numbers in autoimmune disease. Anti-nuclear antibodies value higher than 1:160 is considered positive.|Month 12|ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.||Participants|||Number
780204|NCT00794118|Primary|Number of Participants With Anti-nuclear Antibodies at Month 9|Anti-nuclear antibodies are auto antibodies directed against contents of the nucleus and are present in higher than normal numbers in autoimmune disease. Anti-nuclear antibodies value higher than 1:160 is considered positive.|Month 9|ITT population included all participants who received at least 1 dose of the study medication.||Participants|||Number
780205|NCT00794118|Primary|Number of Participants With Anti-nuclear Antibodies at Month 6|Anti-nuclear antibodies are auto antibodies directed against contents of the nucleus and are present in higher than normal numbers in autoimmune disease. Anti-nuclear antibodies value higher than 1:160 is considered positive.|Month 6|ITT population included all participants who received at least 1 dose of the study medication.||Participants|||Number
780206|NCT00794118|Primary|Number of Participants With Anti-nuclear Antibodies at Month 3|Anti-nuclear antibodies are auto antibodies directed against contents of the nucleus and are present in higher than normal numbers in autoimmune disease. Anti-nuclear antibodies value higher than 1:160 is considered positive.|Month 3|ITT population included all participants who received at least 1 dose of the study medication.||Participants|||Number
780207|NCT00794118|Primary|Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 12|Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual’s own proteins) that are frequently detected in the blood of rheumatoid arthritis participants. Anti-CCP antibodies value higher than 10 U/mL is considered positive.|Month 12|ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.||Participants|||Number
780228|NCT00794118|Primary|Physician Global Assessment (PGA) of Disease Activity at Month 9|PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible.|Month 9|ITT population included all participants who received at least 1 dose of the study medication.||cm||Standard Deviation|Mean
780209|NCT00794118|Primary|Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 6|Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual’s own proteins) that are frequently detected in the blood of rheumatoid arthritis participants. Anti-CCP antibodies value higher than 10 U/mL is considered positive.|Month 6|ITT population included all participants who received at least 1 dose of the study medication.||Participants|||Number
780210|NCT00794118|Primary|Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 3|Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual’s own proteins) that are frequently detected in the blood of rheumatoid arthritis participants. Anti-CCP antibodies value higher than 10 U/mL is considered positive.|Month 3|ITT population included all participants who received at least 1 dose of the study medication.||Participants|||Number
780211|NCT00794118|Primary|Number of Participants With Rheumatoid Factor (RF) at Month 12|RF is the auto antibody directed against IgG and its concentration is observed in human serum or plasma. RF value higher than 20 U/mL is considered positive.|Month 12|ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.||Participants|||Number
780212|NCT00794118|Primary|Number of Participants With Rheumatoid Factor (RF) at Month 9|RF is the auto antibody directed against IgG and its concentration is observed in human serum or plasma. RF value higher than 20 U/mL is considered positive.|Month 9|ITT population included all participants who received at least 1 dose of the study medication.||Participants|||Number
780213|NCT00794118|Primary|Number of Participants With Rheumatoid Factor (RF) at Month 6|RF is the auto antibody directed against IgG and its concentration is observed in human serum or plasma. RF value higher than 20 U/mL is considered positive.|Month 6|ITT population included all participants who received at least 1 dose of the study medication.||Participants|||Number
780214|NCT00794118|Primary|Number of Participants With Rheumatoid Factor (RF) at Month 3|RF is the auto antibody directed against IgG and its concentration is observed in human serum or plasma. RF value higher than 20 U/mL is considered positive.|Month 3|ITT population included all participants who received at least 1 dose of the study medication.||Participants|||Number
780215|NCT00794118|Primary|Erythrocyte Sedimentation Rate (ESR) at Month 12|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.|Month 12|ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.||mm/hr||Standard Deviation|Mean
780216|NCT00794118|Primary|Erythrocyte Sedimentation Rate (ESR) at Month 9|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.|Month 9|ITT population included all participants who received at least 1 dose of the study medication.||mm/hr||Standard Deviation|Mean
780217|NCT00794118|Primary|Erythrocyte Sedimentation Rate (ESR) at Month 6|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.|Month 6|ITT population included all participants who received at least 1 dose of the study medication.||mm/hr||Standard Deviation|Mean
780218|NCT00794118|Primary|Erythrocyte Sedimentation Rate (ESR) at Month 3|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.|Month 3|ITT population included all participants who received at least 1 dose of the study medication.||mm/hr||Standard Deviation|Mean
780219|NCT00794118|Primary|C-reactive Protein (CRP) at Month 12|CRP is a marker of inflammation. CRP value higher than 0.5 mg/dL is consistent with inflammation.|Month 12|ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.||mg/dL||Standard Deviation|Mean
780220|NCT00794118|Primary|C-reactive Protein (CRP) at Month 9|CRP is a marker of inflammation. CRP value higher than 0.5 mg/dL is consistent with inflammation.|Month 9|ITT population included all participants who received at least 1 dose of the study medication.||mg/dL||Standard Deviation|Mean
780221|NCT00794118|Primary|C-reactive Protein (CRP) at Month 6|CRP is a marker of inflammation. CRP value higher than 0.5 mg/dL is consistent with inflammation.|Month 6|ITT population included all participants who received at least 1 dose of the study medication.||mg/dL||Standard Deviation|Mean
780222|NCT00794118|Primary|C-reactive Protein (CRP) at Month 3|CRP is a marker of inflammation. CRP value higher than 0.5 mg/dL is consistent with inflammation.|Month 3|ITT population included all participants who received at least 1 dose of the study medication.||mg/dL||Standard Deviation|Mean
780223|NCT00794118|Primary|Visual Analogue Scale for Pain (VAS-pain) at Month 12|10 cm line (VAS) marked by participant. Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain.|Month 12|ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.||cm||Standard Deviation|Mean
780224|NCT00794118|Primary|Visual Analogue Scale for Pain (VAS-pain) at Month 9|10 cm line (VAS) marked by participant. Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain.|Month 9|ITT population included all participants who received at least 1 dose of the study medication.||cm||Standard Deviation|Mean
780225|NCT00794118|Primary|Visual Analogue Scale for Pain (VAS-pain) at Month 6|10 cm line (VAS) marked by participant. Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain.|Month 6|ITT population included all participants who received at least 1 dose of the study medication.||cm||Standard Deviation|Mean
780226|NCT00794118|Primary|Visual Analogue Scale for Pain (VAS-pain) at Month 3|10 cm line (VAS) marked by participant. Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain.|Month 3|ITT population included all participants who received at least 1 dose of the study medication.||cm||Standard Deviation|Mean
780227|NCT00794118|Primary|Physician Global Assessment (PGA) of Disease Activity at Month 12|PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible.|Month 12|ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.||cm||Standard Deviation|Mean
794157|NCT00911534|Other Pre-specified|Percentage of Participants With Complete Heartburn Relief|Participants completed a daily symptom diary.|Week 2 and Week 4|ITT (n=number of participants with evaluable data)||Percentage of Participants|||Number
780235|NCT00794118|Primary|Disease Activity Score Based on 28-joints Count (DAS28) at Month 12|DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|Month 12|ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.||Units on a Scale||Standard Deviation|Mean
780236|NCT00794118|Primary|Disease Activity Score Based on 28-joints Count (DAS28) at Month 9|DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|Month 9|ITT population included all participants who received at least 1 dose of the study medication.||Units on a Scale||Standard Deviation|Mean
780237|NCT00794118|Primary|Disease Activity Score Based on 28-joints Count (DAS28) at Month 6|DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|Month 6|ITT population included all participants who received at least 1 dose of the study medication.||Units on a Scale||Standard Deviation|Mean
780238|NCT00794118|Primary|Disease Activity Score Based on 28-joints Count (DAS28) at Month 3|DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|Month 3|ITT population included all participants who received at least 1 dose of the study medication.||Units on a Scale||Standard Deviation|Mean
780239|NCT00794118|Primary|Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 12|DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity. A participant is considered to be in remission if they have a DAS28 < 2.6.|Month 12|ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using last observation carried forward (LOCF).||Percentage of participants|||Number
780240|NCT00794118|Primary|Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 9|DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity. A participant is considered to be in remission if they have a DAS28 <2.6.|Month 9|ITT population included all participants who received at least 1 dose of the study medication.||Percentage of participants|||Number
780241|NCT00794118|Primary|Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 6|DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity. A participant is considered to be in remission if they have a DAS28 <2.6.|Month 6|ITT population included all participants who received at least 1 dose of the study medication.||Percentage of participants|||Number
780242|NCT00794118|Primary|Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 3|DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 less than or equal to (<=) 3.2 = low disease activity, DAS28 greater than (>) 3.2 to 5.1 = moderate to high disease activity. A participant is considered to be in remission if they have a DAS28 less than (<) 2.6.|Month 3|Intent-to-Treat (ITT) population included all participants who received at least 1 dose of the study medication.||Percentage of participants|||Number
780243|NCT00794144|Primary|Number of Participants With Anatomic Nasal Exam Abnormalities|The appearance in a participant of any of the following from Baseline: anatomic abnormalities, evidence of infection, bleeding, and/or ulcerations of the mucosa|Day 1 (Baseline) to Exit|||Participants|||Number
780244|NCT00794157|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 (Day 84)|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 50 and 15 minutes pre-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates.|Prior to last dose at Week 12 (Day 84)|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug.||Liters||Standard Error|Least Squares Mean
780245|NCT00794157|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 8|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at Week 8. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates.|After Week 8 (Day 57)|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug.||Liters||Standard Error|Least Squares Mean
780296|NCT00802360|Secondary|Participants With Cycle Cancellation Following One In Vitro Fertilization (IVF) Treatment Cycle|A count of participants whose discontinuation was clearly documented on the study completion/termination form as 1) due to cycle cancelled or 2) cycle cancellation for risk of ovarian hyperstimulation syndrome (OHSS).|Day 1 to Day 24|Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication||participants|||Number
780246|NCT00794157|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 4|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at Week 4. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates.|After Week 4 (Day 29)|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug.||Liters||Standard Error|Least Squares Mean
780247|NCT00794157|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 2|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at Week 2. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates.|After Week 2 (Day 15)|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug.||Liters||Standard Error|Least Squares Mean
780248|NCT00794157|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Treatment (Week 12 + 1 Day, Day 85)|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates.|End of treatment (Week 12 + 1 day, Day 85)|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. The imputation technique used as last observation carried forward (LOCF).||Liters||Standard Error|Least Squares Mean
780249|NCT00794170|Primary|Data on Prescription Drug Renewals, Appointment Compliance and Medication Taking (e.g. Physician Notes)|The adherence measure, developed and pilot tested by the I-SIGHT study team, assessed compliance adherence with medication taking, refills, and appointment-keeping by self-report and chart review. Subjects were considered nonadherent with medication-taking if they reported missing doses of any glaucoma medication within one month of the interview. Levels of medication-taking nonadherence were also examined by missed doses within 7 days, 2 weeks, or 1 mo of the interview. Nonadherence with refills was defined as running out of any glaucoma medication and missing a dose within a specified time frame (i.e. 1 year prior to the baseline interview; 6 months prior to 6-month interview; and 3 months prior to the 9 and 12 month interview). Appointment-keeping nonadherence was indicated by self-report of missing a glaucoma treatment appointment and not rescheduling during the specified time frame. Self-report of nonadherence in any of these three areas classified the subject as nonadherent.|Baseline and 12 months|The two treatment groups were compared on change in the percent of adherent patients between baseline and follow-up using a longitudinal logistic regression model fit using a generalized linear model. A p-value less than 0.05 was considered statistically significant. No statistical comparison was done.||participants|||Number
780250|NCT00794196|Secondary|Patient Wellbeing|"Patient wellbeing EUROQOL5D scale is used to evaluate health-related quality of life.
The answers given to EUROQOL5D allow for the description 243 unique health states which can be converted into EQ-5D index anchored at 0 for death and 1 for perfect health."|0, 3 and 6 months|||units on a scale||95% Confidence Interval|Mean
780251|NCT00794196|Primary|Adherence to Antidepressant Medication|Adherence to antidepressant medication was measured through Pharmacy records|At 3 and 6 months|||percentage of adherence patients||95% Confidence Interval|Number
780252|NCT00794313|Secondary|Modified Abnormal Involuntary Movement Scale Area Under the Curve|Area under the curve computed for whole body (total) mAIMS (Modified Abnormal Involuntary Movement Scale) scores at each time measurement. This is a commonly utilized scale that is completed by an observer who judges the severity of levodopa induced dyskinesia (LID) in 7 body parts (face, neck, trunk, both legs, and both arms). All body parts are rated separately on this 0 (none) to 4 (severe – markedly impairs activities) scale. Thus, the total score can range from 0 – 28 with 28 indicating the most severe LID. mAIMS ratings occur as the subject performs the cognitive task while standing on the force plate. mAIMS ratings are made every half hour during the levodopa (LD) dose cycle.|Measured every 1/2 hour for a levodopa dose cycle (starting 1 hour prior to infusion and ending 4 hours post 2-hour infusion)|||Units on a Scale * Hours||Standard Deviation|Mean
780253|NCT00794313|Primary|Forceplate AUC|Area under the curve for the root mean squared velocity in the anterior-posterior direction as measured by a forceplate.|Every 1/2 hour for 8 hour levodopa cycle|triple cross-over study design.||(meters/second)*hours||Standard Deviation|Mean
780254|NCT00801632|Secondary|Percentage of Participants Experiencing a Clinically Significant Invasive or Resistant Opportunistic Infection|Clinically significant invasive or resistant opportunistic infections include cytomegalovirus, herpes zoster, and candida.|Transplantation until study completion or participant termination (participants followed up to five years)|Intent-to-treat||Percentage of Participants||95% Confidence Interval|Number
780255|NCT00801632|Secondary|Time to Platelet Recovery Following Transplant|Time (in days) until platelet recovery following transplant. Platelet recovery is defined as a platelet count >20,000 /mm^3 and where no transfusion is required. Time to recovery is time from transplantation until platelet value recovers.|Transplantation until study completion or participant termination (participants followed up to five years)|Intent-to-treat||days||Standard Deviation|Mean
780256|NCT00801632|Secondary|Time to Neutrophil Recovery Following Transplant|Time (in days) until neutrophil recovery following transplant. Neutrophil recovery is defined as an absolute neutrophil count (ANC) > 500/mm^3 at three consecutive assessments on different days post-transplant. Time to recovery is time from transplantation until the first assessment date used to confirm the recovery.|Transplantation until study completion or participant termination (participants followed up to five years)|Intent-to-treat||days||Standard Deviation|Mean
780257|NCT00801632|Secondary|Percentage of Participants Surviving Through 156 Weeks|The percentage of participants who survived from transplantation through 156 weeks. Participants who terminated from the study prior to Week 156 without meeting the event were excluded.|Transplantation until week 156|Participants who were followed at least three years after transplantation or experienced death prior to week 156||Percentage of Participants||95% Confidence Interval|Number
794194|NCT00911859|Secondary|1-year Survival Rate|Percentage of participants who are alive at the end of year 1 after randomization|1 year|Intent-to-treat (ITT) population: all randomized participants||Percentage of participants|||Number
780258|NCT00801632|Secondary|Percentage of Participants With Graft Survival Through 156 Weeks|The percentage of participants with graft survival from transplantation through 156 weeks. Participants who terminated from the study prior to Week 156 without meeting the event were excluded. Graft survival is defined as the time to week 156 or graft loss. Graft loss is defined as the day on which a graft is deemed irreversibly nonfunctional and dialysis is begun, a transplantectomy is performed, or the participant is re-transplanted, whichever comes first. Six consecutive weeks of dialysis are required for the diagnosis of graft loss, though the date of graft loss will be defined as the date of first dialysis.|Transplantation until week 156|Participants who were followed at least three years after transplantation or experienced graft loss prior to week 156||Percentage of Participants||95% Confidence Interval|Number
780259|NCT00801632|Secondary|Change in Renal Function|Change in renal function as seen in serum creatinine values from baseline until study completion or participant termination. Baseline is defined as the lowest serum creatinine collected during stabilization period or in the four weeks following the end of the stabilization period. The stabilization period is defined as four consecutive creatinine values close in value (not differing more than 0.3 mg/dL). Higher results indicate poorer kidney function, as creatinine is removed from the body by the kidneys.|Transplantation until study completion or participant termination (up to five years)|Intent-to-treat||mg/dL||Standard Deviation|Mean
780260|NCT00801632|Secondary|Percentage of Participants Experiencing Acute Rejection|The percentage of participants who experience an acute rejection. Acute rejection is defined as a biopsy with findings of Banff score of grade IA or higher. The Banff classification is as follows: grade IA is >25% of parenchyma affected and foci of moderate tubulitis; Grade IB is >25% of parenchyma affected and foci of severe tubulitis; Grade IIA is mild to moderate intimal arteritis; Grade IIB is severe intimal arteritis comprising >25% of the luminal area; Grade III is “transmural” arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation.|Transplantation until study completion or participant termination (up to five years)|Intent-to-treat||Percentage of Participants||95% Confidence Interval|Number
780261|NCT00801632|Primary|Number of Participants Successfully Withdrawn Off of Immunosuppressant Medication for 104 Weeks|A participant was considered a success if they were off immunosuppressive therapy for 104 consecutive weeks leading up to study week 208 (48 months post-transplant) or study termination, whichever occurred first.|48 months post-transplant|Intent-to-treat||participants|||Number
780262|NCT00801684|Secondary|Time to Maximum Plasma Concentration (Tmax) of Trospium After Single Administrations of TrIP|Tmax is reported as median (range) of hours to reach maximum trospium concentration in plasma.|up to 24 hours post-treatment|The PK population consisted of all subjects who received active study medication and had sufficient concentration data to facilitate calculation of the PK parameters or descriptive statistics of concentrations of trospium.||Hours||Full Range|Median
780263|NCT00801684|Secondary|FEV1 Response to Treatment|Response was defined as the number of subjects reporting a post-treatment FEV1 of ≥12% (or 200 mL) above baseline.|Up to 24 hours post-treatment|All 24 randomized subjects were included in the analysis.||Participants|||Number
780264|NCT00801684|Primary|Spirometry Parameter: Peak Forced Expiratory Volume in 1 Second(FEV1)in Liters (L)|"Following screening, each subject was randomized to a sequence of 5 dosing periods (Doses A, B, C, D, and E). Each period was separated by a 3- to 14-day washout interval.
The dosing formulations were as follows:
Dose A = placebo Dose B = TrIP-2D (100 μg TrCl formulated in leucine and DPPC) Dose C = TrIP-2SS (100 μg TrCl formulated in leucine and sodium saccharin) Dose D = TrIP-2D (400 μg TrCl) Dose E = TrIP-2SS (100 μg TrCl) + Foradil (12 μg formoterol fumarate) FEV1 (L)was measured at 15 and 30 minutes, 1, 2, 3, 4, 6, 8, 12 and 24 hours postdose."|15 minutes to 24 hours post-treatment|||Liters||Standard Deviation|Mean
780265|NCT00801801|Secondary|Response Rate in Poor Performance Status Subjects|To assess response rate and tumor control rate (complete remission + partial remission + stable disease) in poor performance status (PS =2) patients with advanced or metastatic (Stage IIIB – pleural effusion/IV) non-squamous cell-NSCLC treated with metronomic chemotherapy plus sorafenib. The objective response was defined as a percentage of those patients that had 30% or more of tumor regression at any time during treatment. Tumor control rate include the percentage of those patients that have less than 20% increase in the target tumor parameters during treatment (stable disease + partial response + complete response).|6 months|||participants|||Number
780266|NCT00801801|Primary|2-month Progression-free Survival Rate|Evaluation of the 2-month progression-free survival in poor performance status patients with non-squamous non-small cell lung cancer with the goal to improve 2-month progression free survival from 50% to 70%. The 2-month progression free survival is determined after 8 weeks on treatment. Those patients that had less than 20% increase in the tumor target lesions are considered as progression free survival. The primary endpoint is the percentage of patients that are progression free in 2 months.|Baseline to 2 months|As the study did not accrue the maximum sample size for statistical analysis, none were done.||participants|||Number
780267|NCT00801827|Primary|Regional DRD2/3 Binding Percent Changes After Bariatric Surgery||~7 weeks|||percentage of binding potential change||Standard Deviation|Mean
780268|NCT00801892|Secondary|Glucose Variability Will be Measured by a Continuous Glucose Monitoring System (CGMS) (Guardian: Medtronic-MiniMed, Northridge, CA).||after one-month||||||
780269|NCT00801892|Primary|The Primary Outcome Variable of the Study, Physical Activity, Will be Measured by the Bodymedia SenseWear Pro Armband® to Determine Physical Activity Levels.||after one-month treatment|||steps walked||Standard Deviation|Mean
780270|NCT00801983|Primary|Musculoskeletal Discomfort|"Discomfort Survey (WDS) was used to assess symptoms and activity limitations. Participants reported on their work schedule, medication used for pain control, and discomfort in their neck/shoulder, back, and bilateral lower arms (elbows, forearms, wrists, and hands) using an 11-point numerical rating scale (0 = no discomfort/no limitations; 10 = unbearable discomfort/major limitations).
We had to dichotomize the data during analysis due to severe skew towards not discomfort (0). Thus the final outcome was discomfort -yes or no"|6 months and 12 months|||percentage of subjects with MSD|||Number
780297|NCT00802360|Secondary|Number of Embryos Frozen at Day 24|The number of embryos that were not transferred but instead were frozen for future use.|Approximately Day 24|Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication and had oocytes fertilized||embryos||Standard Deviation|Mean
780271|NCT00802074|Primary|CL/F: Steady-state Plasma RTG PK Following Administration of RTG 400mg BID Alone and Following Co-administration With FPV 1400mg BID, FPV 700mg/RTV 100 mg BID, or FPV 1400mg/RTV 100mg QD|Amprenavir (APV) is the active ingredient/metabolite of Fosamprenavir (FPV). RAL minimum concentration (Cmin), maximum concentration (Cmax), area under the plasma concentration-time curve (AUC), and oral clearance (CL/F) as determined from RAL concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the period when RAL 400mg BID was administered with the FPV-Containing BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the period when RAL 400mg BID was administered with the FPV QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F.|Day 7 of the RAL 400mg BID regimen and Day 14 of the RAL 400mg/FPV 1400mg BID, RAL 400mg/FPV 700mg/RTV 100mg BID, and RAL 400mg BID Plus FPV 1400mg/RTV 100mg QD regimens|||L/h||90% Confidence Interval|Mean
780272|NCT00802074|Primary|AUC: Steady-state Plasma RTG PK Following Administration of RTG 400mg BID Alone and Following Co-administration With FPV 1400mg BID, FPV 700mg/RTV 100 mg BID, or FPV 1400mg/RTV 100mg QD|Amprenavir (APV) is the active ingredient/metabolite of Fosamprenavir (FPV). RAL minimum concentration (Cmin), maximum concentration (Cmax), area under the plasma concentration-time curve (AUC), and oral clearance (CL/F) as determined from RAL concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the period when RAL 400mg BID was administered with the FPV-Containing BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the period when RAL 400mg BID was administered with the FPV QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F.|Day 7 of the RAL 400mg BID regimen and Day 14 of the RAL 400mg/FPV 1400mg BID, RAL 400mg/FPV 700mg/RTV 100mg BID, and RAL 400mg BID Plus FPV 1400mg/RTV 100mg QD regimens|||ng*h/mL||90% Confidence Interval|Mean
780273|NCT00802074|Primary|Cmin/Cmax: Steady-state Plasma RTG PK Following Admin of RTG 400mg BID Alone and Following Co-administration With FPV 1400mg BID, FPV 700mg/RTV 100 mg BID, or FPV 1400mg/RTV 100mg QD|Amprenavir (APV) is the active ingredient/metabolite of Fosamprenavir (FPV). RAL minimum concentration (Cmin), maximum concentration (Cmax), area under the plasma concentration-time curve (AUC), and oral clearance (CL/F) as determined from RAL concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the period when RAL 400mg BID was administered with the FPV-Containing BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the period when RAL 400mg BID was administered with the FPV QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F.|Day 7 of the RAL 400mg BID regimen and Day 14 of the RAL 400mg/FPV 1400mg BID, RAL 400mg/FPV 700mg/RTV 100mg BID, and RAL 400mg BID Plus FPV 1400mg/RTV 100mg QD regimens|||ng/mL||90% Confidence Interval|Mean
780274|NCT00802074|Primary|CL/F: Fasting Steady-state Plasma Amprenavir (APV) Pharmacokinetics (PK) Following Administration of Fosamprenavir (FPV) 1400mg BID, FPV 700mg/Ritonavir (RTV) 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent Raltegravir (RTG) 400mg BID.|Amprenavir (APV) is the active ingredient/metabolite of Fosamprenavir (FPV). APV minimum concentration (Cmin), maximum concentration (Cmax), area under the plasma concentration-time curve (AUC), and oral clearance (CL/F) as determined from APV concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F.|Day 14 of the FPV 1400mg BID, FPV 1400mg/RAL 400mg BID, FPV 700mg/RTV 100mg BID, FPV 700mg/RTV 100mg/RAL 400mg BID, FPV 1400mg/RTV 100mg QD, and FPV 1400mg/RTV 100mg QD plus RAL 400mg BID regimens|||L/h||90% Confidence Interval|Mean
780275|NCT00802074|Secondary|Number of Participants Who Experienced Adverse Events|"Safety/tolerability data included all adverse events (AEs) reported within the time frame of each regimen evaluated. The intent was to compare AE's for each sequence and not for each regimen. 3The regimens for which AE information was culled were:
RAL 400mg BID alone
FPV 1400mg BID alone
FPV 700mg/RTV 100 mg BID alone
FPV 1400mg/RTV 100mg QD alone
FPV 1400mg BID combined with RAL 400mg BID
FPV 700mg/RTV 100 mg BID combined with RAL 400mg BID
FPV 1400mg/RTV 100mg QD combined with RAL 400mg BID The severity of reported AEs was graded according to DAIDS criteria, Version 1.0 (National Institute of Allergy and Infectious Diseases (NIAID). Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0. Division of Acquired Immunodeficiency Syndrome (DAIDS), Washington D.C.; 2004)."|Day 0 through Day 49|||participants|||Number
780276|NCT00802074|Primary|AUC: Fasting Steady-state Plasma Amprenavir (APV) Pharmacokinetics (PK) Following Administration of Fosamprenavir (FPV) 1400mg BID, FPV 700mg/Ritonavir (RTV) 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent Raltegravir (RTG) 400mg BID.|Amprenavir (APV) is the active ingredient/metabolite of Fosamprenavir (FPV). APV minimum concentration (Cmin), maximum concentration (Cmax), area under the plasma concentration-time curve (AUC), and oral clearance (CL/F) as determined from APV concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F.|Day 14 of the FPV 1400mg BID, FPV 1400mg/RAL 400mg BID, FPV 700mg/RTV 100mg BID, FPV 700mg/RTV 100mg/RAL 400mg BID, FPV 1400mg/RTV 100mg QD, and FPV 1400mg/RTV 100mg QD plus RAL 400mg BID regimens|||ng•h/mL||90% Confidence Interval|Mean
780689|NCT00789854|Secondary|Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) ≤8|Number of patients in remission with total Montgomery Asberg Depression Rating Scale (MADRS) score ≤8. MADRS scale has range from 0 to 60, where the lower score indicates the better health status.|6 weeks of treatment|||Participants|||Number
780277|NCT00802074|Primary|Cmin/Cmax: Fasting Steady-state Plasma Amprenavir (APV) Pharmacokinetics (PK) Following Admin of Fosamprenavir (FPV) 1400mg BID, FPV 700mg/Ritonavir (RTV) 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent Raltegravir (RTG) 400mg BID.|Amprenavir (APV) is the active ingredient/metabolite of Fosamprenavir (FPV). APV minimum concentration (Cmin), maximum concentration (Cmax), area under the plasma concentration-time curve (AUC), and oral clearance (CL/F) as determined from APV concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F.|Day 14 of the FPV 1400mg BID, FPV 1400mg/RAL 400mg BID, FPV 700mg/RTV 100mg BID, FPV 700mg/RTV 100mg/RAL 400mg BID, FPV 1400mg/RTV 100mg QD, and FPV 1400mg/RTV 100mg QD plus RAL 400mg BID regimens|||ng/mL||90% Confidence Interval|Mean
780278|NCT00802100|Secondary|Antipsychotic Efficacy, Defined as Completion of the Trial Without Psychiatric Hospitalization, Clinician Decision to Discontinue Treatment, or Patient Decision to Discontinue Treatment||Measured over 28 weeks of study visits|Analysis population is those randomized. Outcome is discontinuation from study treatment before 28 weeks||participants|||Number
780279|NCT00802100|Primary|Feasibility of Randomizing a Cohort of Participants Meeting the Inclusion and Exclusion Criteria of the Study|Goal was to randomize 60 participants who met eligibility criteria.|Baseline|Total study population||participants|||Number
780280|NCT00802178|Secondary|Global Clinical Assessments of Efficacy of Mirapexin® for All Patients|Successful initiation was defined as a clinical assessment of efficacy by the neurologist rated at least as “good” on a 4 point scale after 4-8 weeks Mirapexin® treatment, where:1 = very good; 2 = good; 3 = moderate; and 4 = poor.|4 - 8 weeks|Treated set (TS)||Number of Participants|||Number
780281|NCT00802178|Secondary|Change From Baseline in UPDRS Part III|Change in UPDRS Part III score from baseline to final visit. Score ranging from 0 - 108 (0= no disability, 108 = worst disability).|Baseline and 4 - 8 weeks|Full Analysis set (FAS)||Unit on a scale|||Number
780282|NCT00802178|Secondary|Change From Baseline in UPDRS (Unified Parkinson’s Disease Rating Scale) Part I|Change in UPDRS Part I score from baseline to final visit. The score ranging from 0-16 (0= no disability, 16= maximum disability)|Baseline and 4 to 8 weeks|Full Analysis set (FAS)||Unit on a scale|||Number
780283|NCT00802178|Primary|Number of De-novo Patients in Whom Monotherapy With Mirapexin® Could be Successfully Initiated|"Successful initiation was defined as a clinical assessment of efficacy by the neurologist rated at least as “good” on a 4 point scale after 4-8 weeks Mirapexin® treatment, where:1 = very good; 2 = good; 3 = moderate; and 4 = poor.
De-novo patients were identified by:
those who were referred: - if ‘Reason for Referral’ = ‘initiation of therapy’ or for ‘diagnostic reason’ and for those not referred: - if initial pharmacotherapy = ‘Mirapexin® monotherapy’ (i.e., no other anti Parkinson Disease (PD) therapy)"|4 - 8 weeks|Full Analysis set (FAS) of De-novo patients in whom monotherapy with Mirapexin® could be successfully initiated||Participants|||Number
780284|NCT00802204|Secondary|Binge Eating Score Questionnaire|Increased scores indicate increased binge eating behaviors. Score 0-46|Baseline|||score from questionnaire||Standard Deviation|Mean
780285|NCT00802204|Primary|Insulin Sensitivity From Oral Glucose Tolerance Test (OGTT_SI)|Insulin Sensitivity from Oral Glucose Tolerance Test was estimated using the minimal model method|Baseline to post 8-10days after VLCD|"9 lean enroll but only 8 complete. A ll lean complete study after baseline outcome measurements.
19 obese enroll but only 18 complete baseline studies and of these 15 completed the VLCD"||10-4*min-1*microU-1*mL||Standard Deviation|Mean
780286|NCT00802204|Primary|Acyl Ghrelin||Baseline to post 8-10days after VLCD|||pg/ml||Standard Deviation|Mean
780287|NCT00802204|Primary|Leptin||Baseline to post 8-10days after VLCD|||ng/ml||Standard Deviation|Mean
780288|NCT00802204|Primary|Glucose||Baseline to post 8-10days after VLCD|||mg/dL||Standard Deviation|Mean
780289|NCT00802204|Primary|Insulin|microU/ml|Baseline to post 8-10days after VLCD|||microU/ml||Standard Deviation|Mean
780290|NCT00802204|Primary|Striatal DRD2 Receptor Binding|Region of interest compared to reference region to calculate binding potential|Baseline and after 8-10days VLCD|Baseline outcome measurements are compared between lean and obese. Baseline and post outcome measurements are compared for the obese who completed VLCD||ratio||Standard Deviation|Mean
780291|NCT00802360|Secondary|Number of Live Births||Approximately 10 months|Database was locked prior to all participants giving birth.||live births|||Number
780292|NCT00802360|Secondary|Participants With Adverse Events (AEs), Including Ovarian Hyperstimulation Syndrome (OHSS)|"Number of participants with adverse events (AEs) that started after first treatment. Severity used a three point scale:
mild=awareness of signs/symptoms, but no disruption of usual activity moderate=event sufficient to affect usual activity (disturbing) severe=event causes inability to work or perform usual activities (unacceptable)
Relatedness to study treatment used a four point scale: unrelated, unlikely, possible, probable.
Seriousness refers to death, hospitalization, a life-threatening experience, persistent or significant disability/incapacity, or congenital anomaly."|Day 1 - week 12|Safety population all randomized and treated participants. The safety population is identical intent-to- treat (ITT) population in this study||participants|||Number
780293|NCT00802360|Secondary|Participants With Clinical Pregnancy at Week 7|Clinical pregnancy is the confirmation of the presence of intrauterine gestational sacs on pregnancy ultrasound examination.|approximately week 7|Intent-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication and had an embryo transfer||participants|||Number
780294|NCT00802360|Secondary|Participants With Biochemical Pregnancy at Day 38|Biochemical pregnancy is a positive β-hCG pregnancy test 12-14 days post embryo transfer.|approximately day 38 (Day 14 post embryo transfer)|Intent-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication and had an embryo transfer||participants|||Number
780295|NCT00802360|Primary|Percentage of Participants With Ongoing Pregnancy at Week 8|The ongoing pregnancy was defined as a positive fetal heart movement (motion) at approximately six weeks of gestation and confirmed in a follow-up pregnancy ultrasound.|Week 8 (Week 6 of gestation)|Intent to treat population||percentage of participants|||Number
780298|NCT00802360|Secondary|Number of Embryos Transferred at Three Stages of Development|The number of embryos, morula and blastocytes transferred to the study participant on either day 3 or day 5 following fertilization.|Approximately Day 24|Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication and had embryos transferred.||embryos||Standard Deviation|Mean
780299|NCT00802360|Secondary|Proportion of Oocytes Fertilized of the Total Number of Oocytes Retrieved|The proportion of the number of oocytes inseminated (fertilized) of the total number of oocytes retrieved.|Approximately Day 19|Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication and had oocytes retrieved.||proportion of oocytes retrieved||Standard Deviation|Mean
780300|NCT00802360|Secondary|Number of Oocytes Retrieved at Day 18|The mean number of oocytes retrieved within 34-36 hours of human chorionic gonadotropin (hCG) administration.|Approximately Day 18|Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication and had oocytes retrieved.||oocytes||Standard Deviation|Mean
780301|NCT00802360|Secondary|Number of Follicles Observed at Day 15|The mean number of follicles observed in both ovaries at the last transvaginal ultrasound in the stimulation phase.|Day 15|Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication||follicles||Standard Deviation|Mean
780302|NCT00802412|Secondary|Percent Relapsing to Any Drinking or Illicit Drug Use|Alcohol or illicit drug use during treatment or follow up.|12-week treatment phase, 36-week combined treatment and follow-up|||percentage of participants|||Number
780303|NCT00802412|Primary|4-week Continuous Abstinence From Smoking|This measure indicates the proportion of participants who did or did not smoke any cigarettes during the final 4 weeks of treatment, which represented weeks 8-12 of study participation.|Weeks 8-12 of treatment.|||percentage of participants abstinent|||Number
780304|NCT00802503|Secondary|Days in Hospital|hospital length of stay|28 days|The intention to treat analysis included all patients randomly assigned to the intervention SPN group (153) or control group EN (152). The per protocol analysis included only patients who fully completed the 5-day intervention in the ICU (SPN group(133); EN group (142).||days in hospital||95% Confidence Interval|Mean
780305|NCT00802503|Secondary|Protein Delivery During the Intervention Period From Day 4 to Day 8|Percentage of protein target between day 4 to 8. Protein target was set to 1.2 g per kg of ideal body weight a day.|5 days|The intention to treat analysis included all patients randomly assigned to the intervention SPN group (153) or control group EN (152). The per protocol analysis included only patients who fully completed the 5-day intervention in the ICU (SPN group(133); EN group (142).||percentage of protein target||Standard Deviation|Mean
780306|NCT00802503|Secondary|ICU Mortality||28 days|The intention to treat analysis included all patients randomly assigned to the intervention SPN group (153) or control group EN (152). The per protocol analysis included only patients who fully completed the 5-day intervention in the ICU (SPN group(133); EN group (142).||participants|||Number
780307|NCT00802503|Secondary|Days in ICU|Days in ICU|28 days|The intention to treat analysis included all patients randomly assigned to the intervention SPN group (153) or control group EN (152). The per protocol analysis included only patients who fully completed the 5-day intervention in the ICU (SPN group(133); EN group (142).||days in ICU||95% Confidence Interval|Mean
780308|NCT00802503|Secondary|General Mortality||28 days|The intention to treat analysis included all patients randomly assigned to the intervention SPN group (153) or control group EN (152). The per protocol analysis included only patients who fully completed the 5-day intervention in the ICU (SPN group(133); EN group (142).||participants|||Number
780309|NCT00802503|Secondary|Total Energy Intake During the Intervention Period , Between Day 4 and Day 8.|Percentage of energy target; in the SPN group the goal was to achieve 100% of the energy target during intervention (day 4 to day 8.The energy target was measured by indirect calorimetry in 198 patients of 305(65%),otherwise energy target was calculated by 25 kcal per kg of ideal body weight for women and 30 kcal per kg of ideal body weight for men and anamnestic body weight was used for patients with a body mass index of 20 kg/m2 or lower.|5 days|The intention to treat analysis included all patients randomly assigned to the intervention SPN group (153) or control group EN (152). The per protocol analysis included only patients who fully completed the 5-day intervention in the ICU (SPN group(133); EN group (142).||% of energy target||Standard Deviation|Mean
780310|NCT00802503|Secondary|Antibiotic Free Days|Number of days between day 9 to day 28 (follow-up period) free of antibiotics|20 days|The intention to treat analysis included all patients randomly assigned to the intervention SPN group (153) or control group EN (152). The per protocol analysis included only patients who fully completed the 5-day intervention in the ICU (SPN group(133); EN group (142).||number of days||95% Confidence Interval|Mean
780311|NCT00802503|Secondary|Hours on Mechanical Ventilation in All Patients|Mechanical ventilation hours during study duration (days 1-28)|28 days|The intention to treat analysis included all patients randomly assigned to the intervention SPN group (153) or control group EN (152). The per protocol analysis included only patients who fully completed the 5-day intervention in the ICU (SPN group(133); EN group (142).||hours of mechanical ventilation||95% Confidence Interval|Mean
780312|NCT00802503|Primary|Documented Infection Rate|Infection, defined according to CDC criteria during the ICU and hospital stay, occurrence between day 9 and day 28|20 days|||Infections|||Number
780313|NCT00802529|Secondary|Change in Speech Discrimination|"Speech discrimination was measured at Baseline, 1month, 2months, 6months, 12month and 24 months follow-up.
Speech discrimination was assessed by means of ipsilesional suprathreshold word recognition (%). Arthur Boothroyd's isophonemic word lists (AB wordlists, Guymark, Southampton) comprising sets of 10 words were played to the ipsilesional ear at the low-frequency pure-tone threshold of 0·5, 1 and 2 kHz +30dB with masking sound in the contralesional ear if necessary. The formula for masking level was: low-frequency pure-tone threshold in ipsilesional ear – bone conduction mean threshold (0·5, 1 and 2KHz) in contralesional ear – 40dB. Speech loudness and masking were rounded to the nearest 5dB. Step increments and decrements of 10dB for speech loudness and masking were used to attain the maximum speech discrimination score."|Baseline, 1,2,6,12 and 24months after initial treatment|||Percentage correct||Standard Deviation|Mean
780314|NCT00802529|Secondary|Change in Hearing|Hearing was measured as ipsilesional pure-tone threshold at Baseline, 1month, 2months, 6months, 12month, 18months and 24 months follow-up. Hearing level was taken as the average threshold across 0.5, 1, 2 and 3KHz.|Baseline, 1,2,6,12,18 and 24months after initial treatment|||dB||Standard Deviation|Mean
780318|NCT00802659|Secondary|Quality of Life|"As measured by the Functional Assessment of Cancer Therapy - Central Nervous System (FACT-CNS)
Participant can chose on a scale of 0-4 with 0=not at all and 4=very much."|4 years|Group 1 was the only group to have a participant enrolled; however this outcome was not measured because there was not enough participants enrolled to provide the needed data for analysis.|||||
780319|NCT00802659|Secondary|Determine the Pattern of Failure After Stereotactic Irradiation of Spinal Metastases.||4 years|Group 1 was the only group to have a participant enrolled; however this outcome was not measured because there was not enough participants enrolled to provide the needed data for analysis.|||||
780320|NCT00802659|Secondary|Determine the Rate of Radiation-induced Myelopathy From Stereotactic Re-irradiation of the Spinal Metastases.||4 weeks|Group 1 was the only group to have a participant enrolled; however this outcome was not measured because there was not enough participants enrolled to provide the needed data for analysis.|||||
780321|NCT00802659|Secondary|Duration of Pain Control for Each Dose Level.|A reduction in pain, referable to the site of the spine lesion, by >=30% according to the Brief Pain Inventory (BPI), or a smaller decrease in pain accompanied by a reduction of pain medications.|4 years|Group 1 was the only group to have a participant enrolled; however this outcome was not measured because there was not enough participants enrolled to provide the needed data for analysis.|||||
780322|NCT00802659|Primary|Optimal Dose of Stereotactic Spinal Irradiation Needed to Obtain Durable Pain Control at 4 Weeks in a Previously Irradiated Spine Field|"Optimal dose
the maximum tolerated dose (MTD) that will result in a 10% ESRT-induced neurological complications
the minimal dose level that can achieve an 80% or more pain control rate, whichever occurs first"|4 weeks|Group 1 was the only group to have a participant enrolled; however this outcome was not measured because there was not enough participants enrolled to provide the needed data for analysis.|||||
780323|NCT00802672|Secondary|Proportion of Subjects With Clinical Cure|Clinical Cure was defined as a signs and symptoms score of <1 for erythema; <1 for scaling; and 0 for pruritus, maceration, fissuring/cracking, and burning/stinging; as well as an assessment that no additional antifungal therapy was required to treat the subject’s current episode of tinea pedis|6 weeks|per protocol population||participants|||Number
780324|NCT00802672|Secondary|Proportion of Subjects With Mycological Cure|Mycological Cure (KOH wet mount negative and fungal culture negative|6 weeks|per protocol population||participants|||Number
780325|NCT00802672|Primary|Proportion of Subjects in Each Treatment Group With Therapeutic Success|Both Mycological Cure (KOH wet mount negative and fungal culture negative) and Clinical Cure were required to achieve Therapeutic Success|6 weeks|Per protocol population||participants|||Number
780326|NCT00802685|Secondary|Number of Participants on Oxygen at 36 Weeks Postmenstrual Age||at 36 weeks postmenstrual age|||participants|||Number
780327|NCT00802685|Primary|Days Spent on Supplemental Oxygen During the First 28 Days.||28 days of life|The number of participants for analysis was determined from all subjects who completed the study intervention at 28 days of age and had complete data on the primary endpoint of oxygen days during the first 28 days. Analysis was done on intention to treat basis.||days||Full Range|Median
780328|NCT00802737|Secondary|Cmax and Ctrough at Visit 2 (Week 0) and at Visit 14 (Month 4)|Cmax is defined as the maximum concentration of drug in plasma samples (collected at the end of the infusion). Ctrough is defined as the concentration of drug in plasma samples at the end of a dosing interval (collected directly before next administration). Ctrough before the first infusion represents residual ofatumumab from participation in Study Hx-CD20-406.|Visit 2 (Week 0) and Visit 14 (Month 4)|FAS. Data are provided for the number of participants attending each visit. Participants withdrawn during the study were not analyzed.||Milligrams per liter (mg/L)||95% Confidence Interval|Geometric Mean
780329|NCT00802737|Secondary|Number of Participants With Infections Requiring Hospitalization or Intravenous Antibiotics|The data collected for this analysis are reported in the overall SAEs of infections rather than reported separately for this specific analysis. This is a conservative approach for reporting all infectious SAEs in order to ensure that all of the infectious SAEs are represented.|From the first infusion (Visit 2/Week 0) until the last visit of the Extended Follow-up Phase (up to Study Month 26 [visit 34])|FAS|||||
780330|NCT00802737|Secondary|Number of Participants With the Indicated Major Infections|The data collected for this analysis are reported in the overall Serious Adverse Events (SAEs) of infections rather than reported separately for this specific analysis. This is a conservative approach for reporting all infectious SAEs in order to ensure that all of the infectious SAEs are represented.|From the first infusion (Visit 2/Week 0) until the last visit of the Extended Follow-up Phase (up to Study Month 26 [visit 34])|FAS|||||
780331|NCT00802737|Secondary|Number of Participants Who Experienced Any Adverse Event|An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with the treatment. A list of AEs experienced in the study with a frequency threshold of 5% can be found in the AE section of this results record.|From the first infusion (Visit 2/Week 0) until the last visit of the Extended Follow-up Phase (up to Study Month 26 [visit 34])|FAS||participants|||Number
780332|NCT00802737|Secondary|Number of Participants With Negative and Positive Human Anti-human Antibody (HAHA) Results at the Time of Screening and Post Ofatumumab|HAHAs are indicators of immunogenicity to ofatumumab. HAHA levels were assessed for each participant at the end of participation in the study (at their last visit). A positive HAHA status indicates a positive enzyme-linked immunosorbent assay (ELISA) result, an inconclusive status indicates a negative ELISA result at ofatumumab concentration above the threshold at which ofatumumab may interfere with the assay, and a negative status indicates a negative ELISA result at ofatumumab concentration below the threshold.|Screening and post ofatumumab (up to Study Month 32)|"FAS. During the study, samples were to be taken at the last visit; however, this may not have been possible, such as in cases of death, or when the visit was not obvious as the last visit. Therefore, some samples were not available or were not collected."||participants|||Number
780347|NCT00802841|Secondary|Percentage of Participants With Major Molecular Response (MMR)|MMR was defined as having a fusion gene of the Bcr and Abl genes of (BCR-ACL) less than or equal to 0.1% on the International Scale (IS).|12 and 24 months|Full Analysis Set: The FAS included all participants to whom study treatment had been assigned by randomization.||Percentage of participants|||Number
780333|NCT00802737|Secondary|Median Percent Change of Tumor Size (Sum of Products Dimensions [SPD]) From Baseline (Visit 2) at Month 24|Reduction in tumor size was measured by the percentage change in the sum of products of the diameters of the largest abnormal lymph nodes from Baseline to Month 24. Percent change was calculated as (Month 24 SPD minus Baseline SPD)/Baseline SPD * 100.|Baseline (Visit 2) and Month 24|FAS. No participants in the 2000 mg Ofatumumab + Other treatment arm were able to contribute to this measure. Measurement of tumor size was completed by physical examination for participants remaining in the study at Month 24. Only participants with a baseline value and a post-baseline value at Month 24 were included in the calculation.||Percent change in tumor size||Full Range|Median
780334|NCT00802737|Secondary|Median Percent Change of Tumor Size (Sum of Products Dimensions [SPD]) From Baseline (Visit 2) at Month 12|Reduction in tumor size was measured by the percentage change in the sum of products of the diameters of the largest abnormal lymph nodes from Baseline to Month 12. Percent change was calculated as (Month 12 SPD minus Baseline SPD)/Baseline SPD * 100.|Baseline (Visit 2) and Month 12|FAS. No participants in the 2000 mg Ofatumumab + Other treatment arm were able to contribute to this measure. Measurement of tumor size was completed by physical examination for participants remaining in the study at Month 12. Only participants with a baseline value and a post-baseline value at Month 12 were included in the calculation.||Percent change in tumor size||Full Range|Median
780335|NCT00802737|Secondary|Median Percent Change of Tumor Size (Sum of Products Dimensions [SPD]) From Baseline (Visit 2) at Month 4|Reduction in tumor size was measured as the percent change in the sum of the products of the diameters of the largest abnormal lymph nodes from Baseline to Week 24. Percent change was calculated as (Week 24 SPD minus Baseline SPD)/Baseline SPD * 100.|Baseline (Visit 2) and Month 4|FAS. Measurement of tumor size was completed by physical examination for participants remaining in the study at Month 4. Only participants with a baseline value and a post-baseline value at Month 4 were included in the calculation.||Percent change in tumor size||Full Range|Median
780336|NCT00802737|Secondary|Overall Survival (OS)|OS is defined as the time from allocation to death.|Time from start of study treatment (Week 0 of Visit 2) until date of death or time that participant was no longer followed (median of 18.0 months)|FAS||months||95% Confidence Interval|Median
780337|NCT00802737|Secondary|Time to Next Chronic Lymphocytic Leukemia (CLL) Treatment|Time to next chronic lymphocytic leukemia (CLL) treatment is defined as the time from treatment allocation/randomization (Visit 2) until the time of the first administration of the next CLL treatment other than ofatumumab (or HuMaxCD20, a fully human monoclonal antibody to CD20 that is expressed on the surface of B-cells).|Time from start of study treatment (Week 0 of Visit 2) until the time of first administration of a CLL treatment other than ofatumumab (average of 14.8 study months)|FAS||months||95% Confidence Interval|Median
780338|NCT00802737|Secondary|Progression-Free Survival (PFS)|PFS is defined as the time from randomization until progression (prog.)/death. Prog. events are defined by well-documented and verifiable data; other data are censored. If the par. had prog. between scheduled visits, died before the first assessment, or died between adequate visits, the endpoint was considered progressed. If there was no prog. at the end of the trial, treatment discontinuation for undocumented prog./toxicity/other reason, new anti-cancer treatment, and death/prog. after >=2 missed visits in a row, the endpoint was censored. Clinical prog. is not considered as a prog. endpoint.|Start of treatment (Week 0 of Visit 2) until progression or death (average of 14.1 study months)|FAS||months||95% Confidence Interval|Median
780339|NCT00802737|Secondary|Duration of Response|Duration of response is defined as the time from the initial response (first visit at which response is observed) to progression or death. If the participant had progression between scheduled visits, no progression at the end of the trial, treatment discontinuation for undocumented progression, treatment discontinuation for toxicity or other reason, new anti-cancer treatment, and experienced death or progression after two or more missed visits in a row the endpoint was censored.|From the time of the initial response until progression or death (average of 14.1 study months)|FAS||months||95% Confidence Interval|Median
780340|NCT00802737|Primary|Number of Participants (Par.) Classified as Responders (Rs) and Non-responders (NRs) for Objective Response in Accordance With the National Cancer Institute Working Group (NCIWG) 1996 Guidelines|Par. with complete remission (CR), nodular partial remission (nPR), and partial remission (PR) on 2 consecutive visits >=56 days apart were classified as Rs; those with stable disease (SD)/progressive disease (PD) were classified as NRs. Per the NCIWG 1996 guidelines: CR; no lymphadenopathy/hepatomegaly/splenomegaly/constitutional symptoms, normal hematology, normocellular bone marrow sample for age, <30% lymphocytes (LC), no lymphoid nodule; PR: >=50% decrease in LC/lymphadenopathy; nPR: persistent bone marrow nodules; PD: new lesion or increase by >=50% from baseline; SD: no CR, PR, or PD.|Start of treatment (Week 0/Visit 2) until Week 52|Full Analysis Set (FAS): all participants who had been exposed to study drug irrespective of their compliance to the planned course of treatment. Some participants were not evaluable (NE) due to participant withdraw, refusal, non-trial drug-related adverse events, and death.||participants|||Number
780341|NCT00802841|Secondary|Overall Survival (OS)|OS was defined as time from date of randomization to the date of the death.|24 months|Full Analysis Set: The FAS included all participants to whom study treatment had been assigned by randomization.||Months||95% Confidence Interval|Median
780342|NCT00802841|Secondary|Event-Free Survival (EFS)|EFS was defined as the time from the date of randomization to the date of the first occurrence of any of the following: loss of Complete Hematological Response (CHR), loss of Partial Cytogenetic Response (PCyR), loss of CCyR, death on treatment or progression to AP/BC.|24 months|Full Analysis Set: The FAS included all participants to whom study treatment had been assigned by randomization.||Months||95% Confidence Interval|Median
780343|NCT00802841|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time from the date of randomization to the date of documented disease progression to accelerated phase or blast crisis (AP/BC), or death due to any cause.|24 months|Full Analysis Set: The FAS included all participants to whom study treatment had been assigned by randomization.||Months||95% Confidence Interval|Median
780344|NCT00802841|Secondary|Duration of CCyR|Duration of CCyR was defined as time from the date of ransomization to the date of first loss of CCyR or death, whichever came first.|24 months|Full Analysis Set: The FAS included all participants to whom study treatment had been assigned by randomization.||Months||95% Confidence Interval|Median
780345|NCT00802841|Secondary|Time to CCyR|Time to CCyR was defined as time from date of randomization to date of first documented CCyR.|24 months|Full Analysis Set: The FAS included all participants to whom study treatment had been assigned by randomization.||Months||95% Confidence Interval|Median
780348|NCT00802841|Primary|Percentage of Participants With Complete Cytogenetic Response (CCyR)|CCyR was assessed from bone marrow samples. CCyr was defined as having 0% Philadelphia positive (Ph+) chromosome metaphases in bone marrow.|6 months|Full Analysis Set: The FAS included all participants to whom study treatment had been assigned by randomization.||Percentage of participants|||Number
780349|NCT00802867|Primary|Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel®|"Solicited local reactions: Redness, swelling, tenderness at injection site, change in limb circumference, and limb function.
Systemic reactions: Fever (temperature), irritability, crying, lethargy, appetite decreased, vomiting, diarrhea, and rash."|0 to 3 days post-dose 5 vaccination|Safety analysis was on all enrolled and vaccinated participants intend-to-treat population.||Percentage of Participants|||Number
780350|NCT00802867|Other Pre-specified|Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose||Pre-dose 5 and Day 28 to 48 Post-dose 5|The GMTs of anti-Pertussis, anti-Diphtheria, and anti-Tetanus Toxoids Responses were evaluated in a subset of the per-protocol population for immunogenicity.||Titers||95% Confidence Interval|Geometric Mean
780351|NCT00802867|Other Pre-specified|Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Seroprotection Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose|Seroprotection is defined as a titer of ≥ 0.01 IU/mL for both Diphtheria and Tetanus before the fifth dose booster vaccination|Day 28 to 48 Post-dose 5|The anti-Diphtheria and anti-Tetanus Toxoids Responses were evaluated in a subset of the per-protocol population for immunogenicity.||Percentage of Participants|||Number
780352|NCT00802867|Other Pre-specified|Percentage of Participants With Anti-Pertussis Booster Response Post-vaccination With DAPTACEL® as a Fifth Dose|Booster response calculation: If Pre-Dose 5 titer < 4x limit of quantitation (LOQ), a 4-fold rise of Post-dose 5/Pre-dose 5; If Pre-dose 5 titer ≥ 4x LOQ, a 2-fold rise of Post-dose 5/Pre-dose 5.|Day 28 to 48 Post-dose 5|The anti-Pertussis Booster response was evaluated in a subset of the per-protocol population for immunogenicity.||Percentage of participants|||Number
780353|NCT00802867|Other Pre-specified|Percentage of Participants With 4-Fold Rises in Anti-Pertussis Post-vaccination With DAPTACEL® as a Fifth Dose.|"Anti-pertussis (anti-Pertussis, anti-Filamentous Haemagglutinin, anti-Fimbriae, and anti-Pertactin).
Fold-rise is calculated as Post-Dose 5/Pre-Dose 5 titer."|Day 28 to 48 Post-dose 5|The vaccine antibody responses were evaluated in a subset of the per-protocol population for immunogenicity.||Percentage of Participants|||Number
780354|NCT00802880|Secondary|Correlate Overall Survival With Best Metabolic Response||Completion of follow-up (estimated to be 1 year)|28 patients were not evaluable for this outcome measure due to various reason such as progressive disease prior to cycle 3, unknown survival status, no target lesion on PET scan, and toxicity.||months||95% Confidence Interval|Median
780355|NCT00802880|Secondary|Correlate Overall Survival With Best Anatomic Response||Completion of follow-up (estimated to be 1 year)|26 patients were not evaluable for this outcome measure for various reasons including unknown survival status, progressive disease prior to cycle 3, no anatomic response noted, and toxicity.||months||95% Confidence Interval|Median
780356|NCT00802880|Secondary|Correlate Time to Progression With Best Metabolic Response|-Progression - At least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Completion of follow-up (estimated to be 1 year)|31 patients were not evaluable due to various reasons such as toxicity, progressive disease prior to completion of cycle 3, patient refusal, and no target lesions on PET scan.||months||95% Confidence Interval|Median
780357|NCT00802880|Secondary|Correlate the Time to Progression With Best Anatomic Response|-Progression - At least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Completion of follow-up (estimated to be 1 year)|29 patients were not evaluable due to various reasons such as toxicity, progressive disease prior to completion of cycle 3, patient refusal, and no anatomic response recorded.||months||95% Confidence Interval|Median
780358|NCT00802880|Secondary|Overall Survival||Until completion of follow-up or patient death (estimated to be 1 year)|One patient with invalid time or censoring value was not included.||months||95% Confidence Interval|Median
780359|NCT00802880|Secondary|Time to Progression (TTP)|-Progression - At least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Until completion of follow-up (estimated to be 1 year)|10 patient observations with invalid time or censoring values were not included.||months||95% Confidence Interval|Median
780360|NCT00802880|Secondary|Overall Disease Control Rate||12 months|Only 6 patients were evaluable for response at the end of 12 cycles.||participants|||Number
780361|NCT00802880|Secondary|Correlate the Tumor Metabolic Response Rate With the Tumor Anatomic Response Rate||After completion of 3 cycles|31 patients were not evaluable due to various reasons such as toxicity, progressive disease prior to completion of cycle 3, patient refusal, and no target lesions on PET scan.||participants|||Number
780362|NCT00802880|Secondary|Overall Tumor Metabolic Response|"Complete metabolic response (CMR)-complete resolution of all metabolically active target and non-target lesions, and no interval development of new lesions.
Partial metabolic response (PMR)
Target lesions: 20% or greater decrease in maximum SUV from baseline. No unequivocal metabolic progression of non-target disease, and no unequivocal new lesions.
Non-target lesions: decrease in total number of non-target lesions, without complete resolution of metabolically active disease, or unequivocal decrease in degree of FDG activity within >50% of the lesions. No unequivocal new lesions.
Stable metabolic disease (SMD): does not qualify for CMR, PMR, or PMD.
Progressive metabolic disease (PMD):
Unequivocal development of one more new metabolically active lesions
Target lesion: 20% or greater increase in maximum SUV from baseline.
Non-target lesions: unequivocal increase in FDG activity"|After completion of 3 cycles|29 patients were not evaluable due to various reasons such as toxicity, progressive disease prior to completion of cycle 3, patient refusal, and no target lesions on PET scan.||participants|||Number
780363|NCT00802880|Secondary|Comparison of the SUV at up to 3 Tumor Sites||Baseline and after every three cycles of treatment (up to 1 year)|The lower confidence limit is 85% and the upper confidence limit is 95%. 51 patients evaluable at baseline, 50 patients evaluable at end of cycle 3, 20 patients evaluable at end of cycle 6, 7 patients evaluable at end of cycle 9, and 5 patients evaluable at end of cycle 12.||standard uptake value||95% Confidence Interval|Mean
780366|NCT00802880|Primary|Best Anatomical Tumor Response|"Complete response (CR): disappearance of all target lesions, disappearance of all non-target lesions, normalization of tumor level marker
Partial response (PR): at least 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD, persistence of one or more non-target lesion and/or maintenance of tumor marker level above the upper limits of normal
Stable disease (SD): neither sufficient shrinkage in target lesions to qualify for PR nor sufficient increase to qualify for progressive disease taking as references the smallest sum LD since the treatment started, persistence of one or more non-target lesion and/or maintenance of tumor marker level above the normal limits of normal
Progressive disease (PD): at least 20% increase in the sum of the LD of target lesions and/or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions"|After completion of 3 cycles|3 patients failed to complete 3 cycles of treatment due to toxicity. 22 patients failed to complete 3 cycles of treatment due to progressive disease. 1 patient only had PET scan.||participants|||Number
780367|NCT00802893|Secondary|Evaluate the Efficacy of Oral 6R-BH4 Versus Dosage-equivalent Placebo to Improve Endothelia Function, to Reduce SBP, to Reduce Arterial Stiffness||4-8 weeks|Due to difficulties recruiting, this study was terminated and no data was collected.|||||
780368|NCT00802893|Primary|Evaluate the Efficacy of 6R-BH4 Versus Placebo to Improve Endothelia Function||4-6 weeks|Due to difficulties recruiting, this study was terminated and no data was collected.|||||
780369|NCT00802997|Other Pre-specified|Pain Status Change for Sacroiliac Joint Pain Intensity|Scale ranges from 0 to 10. A score of 0 represents no pain and a score of 10 represents the highest level of pain.|Baseline and 9 Months|||units on a scale||Standard Deviation|Mean
780370|NCT00802997|Other Pre-specified|Pain Status Change for Sacroiliac Joint Pain Intensity|Scale ranges from 0 to 10. A score of 0 represents no pain and a score of 10 represents the highest level of pain.|Baseline and 6 Months|||units on a scale||Standard Deviation|Mean
780371|NCT00802997|Primary|Pain Status Change for Sacroiliac Joint Pain Intensity|Scale ranges from 0 to 10. A score of 0 represents no pain and a score of 10 represents the highest level of pain.|Baseline and 3 months|||units on a scale||Standard Deviation|Mean
780372|NCT00803010|Secondary|2 Year Post Transplant Overall Survival (OS) Rate|Defined as time from transplantation (day 0 as day of stem cell infusion per standard nomenclature) to death from any cause .|2 years|All participants who received treatment||percentage of participants||95% Confidence Interval|Number
780373|NCT00803010|Secondary|Incidence of Increased Absolute Numbers of Regulatory T Cells (Treg)|Absolute numbers of Treg at designated time points according to study arm. MTX = methotrexate/tacrolimus-treated patients; SIR = sirolimus/tacrolimus-treated patients; Treg absolute number units = number of cells/microL. A two-sided Wilcoxon's rank-sum test was employed to test differences in percent Treg (% Treg/total CD4+ cells).|30 days and 90 days|||Cells/MicroL||95% Confidence Interval|Median
780374|NCT00803010|Primary|Percentage of Participants With Evidence of Acute Graft Versus Host Disease (aGVHD), Post Transplant|"Incidence of acute graft versus host disease grades 2-3 according to the Common Toxicity Criteria (CTC) version 3.
Graft-versus-host-disease (GVHD) is a risk associated with allogeneic hematopoietic cell transplants (HCT). Clinical evidence of acute GVHD was recorded per standard grading scheme.
Acute GVHD classified as the following:
classic acute GVHD - onset within 100 days after transplant
persistent – acute GVHD with onset prior to day 100 and without resolution beyond day 100
recurrent – acute GVHD recurrent after prior episode of acute GVHD
late acute GVHD – syndrome consistent with acute GVHD, without features of chronic GVHD, with onset occurring beyond 100 days"|100 Days Post Transplant|All participants who received treatment||percentage of participants||95% Confidence Interval|Number
780375|NCT00803023|Secondary|Tolerability Assessed by Adverse Events||4 weeks||||||
780376|NCT00803023|Primary|Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects||4 weeks|||participants|||Number
780377|NCT00803049|Secondary|Magnetic Resonance Imaging (MRI) Assessment: Change From Baseline in Total Volume of Abnormal Lesions (Burden of Disease [BOD]) at Week 192 Since LTS6050 Randomization|BOD was assessed by cerebral MRI and defined as the total volume of all abnormal brain tissue (calculated as the sum of the total volume of T2-lesion component and T1-hypointense lesion component).|Baseline, Week 192|ITT (LTS6050 population). Number of participants analyzed=participants with available data for this outcome measure.||millilitres (ml)||Standard Deviation|Mean
780378|NCT00803049|Secondary|Annualized MS Relapse Rate (ARR): Poisson Regression Estimates|"ARR was obtained from total number of confirmed relapses that occurred during treatment period divided by sum of treatment durations in LTS6050 study only. Each episode of relapse - appearance, or worsening of a clinical symptom that was stable for at least 30 days, that persisted for a minimum of 24 hours in the absence of fever was to be confirmed by an increase in EDSS score or Functional System (FS) scores. EDSS: an ordinal scale qualifies disability. EDSS total score range: 0 (normal neurological examination) to 10 (death due to MS). FSS: to assess the neurological function. Total score range: 0 (normal) - 6(worse), higher scores = worse neurological function. To account for the different treatment duration among participants, a Poisson regression model with robust error variance was used (total number of confirmed relapses as response variable; log transformed treatment duration as offset variable; treatment group, region of enrolment and baseline EDSS stratum as covariates)."|Up to 8 years since LTS6050 randomization|ITT(LTS6050) population: all participants who were randomized in the LTS6050 study and had at least 1-day IMP exposure during the LTS6050 study.||relapses per participant-year||95% Confidence Interval|Number
780379|NCT00803049|Secondary|Percentage of Participants Free of Sustained Disability Progression (DP)|Sustained DP was defined as sustained increase of at least 1 point from baseline (EFC6049) EDSS score (0.5 point for participants with baseline EDSS>5.5) persisting for at least 12 weeks and 24 weeks. EDSS is an ordinal scale in half-point increments that qualifies disability in participants with MS. It consists of 8 ordinal rating scales assessing seven functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder, cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), where higher scores indicates worse neurological function. Percentage of participants who were considered as free of disability progression confirmed after 12 week sustained progression and 24 week sustained progression were reported. Analysis for this outcome measure was performed on combined data of EFC6049 and LTS6050 study, as pre-specified in protocol.|Up to 10.8 years since EFC6049 randomization (EFC6049: 108 weeks + LTS6050: 450 weeks)|Intent-to-treat (ITT) (EFC6049 [NCT00134563] + LTS6050) population.||percentage of participants|||Number
780380|NCT00803049|Secondary|Time to 24 Week Sustained Disability Progression (DP): Kaplan-Meier Estimates of the Rate of DP|Sustained DP was defined as sustained increase of at least 1 point from baseline (EFC6049) EDSS score (0.5 point for participants with baseline EDSS>5.5) persisting for at least 24 weeks. EDSS: an ordinal scale qualifies disability in participants with MS. EDSS total score range: 0 (normal neurological examination) to 10 (death due to MS). Probability of DP at 24 weeks was estimated using Kaplan-Meier method on time to DP defined as date of first DP minus (-) date of randomization in EFC6049 study +1 day. Participants free of DP (no DP observed on treatment) were censored at the date of last on-treatment EDSS evaluation in LTS6050. Kaplan-Meier method consists in computing probabilities of non-occurrence of event at any observed time of event and multiplying successive probabilities for time ≤t by any earlier computed probabilities to estimate the probability of being event-free for the amount of time t.|Up to 10.8 years (EFC6049: 108 weeks + LTS6050: 450 weeks)|Intent-to-treat (ITT) (EFC6049+ LTS6050) population: all participants randomized in both EFC6049 and LTS6050 studies that had at least 1-day IMP exposure during both EFC6049 and LTS6050 studies. Analysis for this outcome measure was performed on the combined data of EFC6049 andLTS6050 study, as pre-specified in the protocol.||Probability||95% Confidence Interval|Number
780381|NCT00803049|Secondary|Time to 12 Week Sustained Disability Progression (DP): Kaplan-Meier Estimates of the Rate of DP|Sustained DP defined as sustained increase of at least 1 point from baseline (EFC6049) expanded disability status scale (EDSS) score (0.5 point for participants with baseline EDSS>5.5) persisting for at least 12 weeks. EDSS: an ordinal scale qualifies disability in participants with MS. EDSS total score range: 0 (normal neurological examination) to 10 (death due to Multiple Sclerosis [MS]). Probability of DP at 12 weeks was estimated using Kaplan-Meier method on time to DP defined as date of first DP minus (-) date of randomization in EFC6049 study +1 day. Participants free of DP (no DP observed on treatment) were censored at the date of last on-treatment EDSS evaluation in LTS6050. Kaplan-Meier method consists in computing probabilities of non-occurrence of event at any observed time of event and multiplying successive probabilities for time ≤t by any earlier computed probabilities to estimate the probability of being event-free for the amount of time t.|Up to 10.8 years (EFC6049: 108 weeks + LTS6050: 450 weeks)|Intent-to-treat (ITT) (EFC6049+ LTS6050) population: all participants randomized in both EFC6049 and LTS6050 studies that had at least 1-day IMP exposure during both EFC6049 and LTS6050 studies. Analysis for this outcome measure was performed on the combined data of EFC6049 andLTS6050 study, as pre-specified in the protocol.||Probability||95% Confidence Interval|Number
780382|NCT00803049|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)|Adverse event (AE) was defined as any untoward medical occurrence in a participant who received investigational medicinal product (IMP) without regard to possibility of causal relationship with this treatment. TEAEs: AEs that developed or worsened or became serious during on-treatment period which was defined as the period from the time of first dose of study drug (in LTS6050) up to 4 weeks (28 days) after last dose of study drug. Serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included both serious and non-serious AEs.|Baseline (LTS6050) up to 28 days after last dose of study drug up to 450 weeks|Safety population: all participants randomized in the LTS6050 study and exposed to IMP during the LTS6050 study treatment period, regardless of the amount of treatment administered. The safety analysis was conducted as the treatment received.||percentage of participants|||Number
780383|NCT00803062|Other Pre-specified|Prevalence of Active Smoking|An estimate of the prevalence of active smoking will be calculated. Will be assessed for associations with progression and/or death.|Up to 5 years||||||
780384|NCT00803062|Other Pre-specified|Number of CTCs|Associations between biomarkers and overall survival or progression-free survival will be examined in a Cox proportional hazards model that includes significant prognostic variables based on prior research such as performance status, prior cisplatin therapy, and stage of disease. Logistic regression will be used to help assess the value of biomarkers in predicting response to a particular treatment or determine associations with response.|Up to 5 years||||||
780385|NCT00803062|Other Pre-specified|Levels of Tumor Measures of Angiogenesis|Associations between biomarkers and overall survival or progression-free survival will be examined in a Cox proportional hazards model that includes significant prognostic variables based on prior research such as performance status, prior cisplatin therapy, and stage of disease. Logistic regression will be used to help assess the value of biomarkers in predicting response to a particular treatment or determine associations with response.|Up to 5 years||||||
780386|NCT00803062|Other Pre-specified|Levels of Cell-free DNA in Plasma|Associations between biomarkers and overall survival or progression-free survival will be examined in a Cox proportional hazards model that includes significant prognostic variables based on prior research such as performance status, prior cisplatin therapy, and stage of disease. Logistic regression will be used to help assess the value of biomarkers in predicting response to a particular treatment or determine associations with response.|Up to 5 years||||||
780387|NCT00803062|Other Pre-specified|Levels of Angiogenesis Markers in Plasma|Associations between biomarkers and overall survival or progression-free survival will be examined in a Cox proportional hazards model that includes significant prognostic variables based on prior research such as performance status, prior cisplatin therapy, and stage of disease. Logistic regression will be used to help assess the value of biomarkers in predicting response to a particular treatment or determine associations with response.|Up to 5 years||||||
780388|NCT00803062|Other Pre-specified|Health-related Quality of Life|Assessed by FACT-Cx TOI; FACT/GOG-Ntx4 subscale; and BPI at baseline, before courses 2 and 5, and at 6 and 9 months after course 1. The linear mixed model will be used to evaluate the hypotheses on FACT-Cx TOI score, adjusting for baseline FACT-Cx TOI scores and age. A mixed-effects mixed-distribution model will be considered to analyze NTx4 subscale scores and the BPI score. 95% confidence intervals will be reported for the estimated treatment differences of BPI score.|Up to 9 months after course 1||||||
780389|NCT00803062|Other Pre-specified|Extent of Nicotine Dependence|Assessed from answers the patients provide to a questionnaire. Will be assessed for associations with progression and/or death.|Up to 5 years||||||
780883|NCT00791258|Secondary|Percentage of Participants Previously on a Diuretic Achieving the Blood Pressure Goals From Baseline to 12 Weeks||Baseline to 12 weeks|Participants previously on a diuretic who have received at least one dose of study medication and who have a baseline value.||Percentage of participants|||Number
780390|NCT00803062|Primary|Incidence of Adverse Events Assessed by National Cancer Institute CTCAE Version 3.0.|The frequency and severity of adverse events will be determined. Defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease that occurs in a patient administered a medical treatment, whether the event is considered related or unrelated to the medical treatment|Up to 30 days after completion of study treatment||||||
780391|NCT00803062|Primary|Tumor Response|Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions by CT, MRI or CXR. If the only target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% increase in longest diameter is required; Overall Response (OR) = CR + PR.|Every cycle (if assessed by physical exam), every other cycle (if assessed by imaging), after the final cycle, then every 3 months x 2 years, then every 6 months x 3 years up to 5 years.|All randomized patients.||percentage of participants||95% Confidence Interval|Number
780392|NCT00803062|Primary|Progression-free Survival|"Disease that can be assessed clinically (physical examination) should be evaluated every cycle (every 3 weeks). Disease assessed by imaging modalities (CXR, CT, MRI) should be evaluated every other cycle unless other evidence of a change mandates earlier assessment. Tumor measurements should also be done after the final cycle (if the patient is taken off of study therapy for a reason other than progression) and then every 3 months x 2 years (followed with every 6 months x 3 years) until progression is documented. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions assessed radiographically and 50% increase if the only target lesion is a solitary pelvic mass measured by physical exam, or unequivocal progression of a non-target lesion, or the appearance of new lesions, or similar definition as accurate and appropriate."|From study entry until disease progression, death or date of last contact, assessed up to 5 years (During treatment: every 3 weeks if by physical exam, every 6 weeks by CXR, CT or MRI. In follow-up: quarterly for 2 years then semi-annually for 3 years)|All randomized patients.||months||95% Confidence Interval|Median
780393|NCT00803062|Primary|Overall Survival|The observed length of life from randomization into the study to death or the date of last contact.|From entry into the study to death or the date of last contact, assessed up to 5 years|All randomized patients.||months||95% Confidence Interval|Median
780394|NCT00803101|Secondary|Overall Treatment-emergent Adverse Events (TEAEs)|Number of participants with TEAEs. TEAEs were defined as adverse events that developed or worsened following exposure to investigational medicinal product. Treatment-related TEAEs were events whose relationship to study treatment was related, probably related, or possibly related in the opinion of the investigator. Treatment emergent adverse events with missing relationship were considered related to treatment. Serious TEAEs were treatment-emergent serious adverse events (SAEs).|From the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs and from the start of infusion up to the allowed time window of the Day 45 visit for SAEs|The Intention-to-Treat Safety (ITT-S) population included all participants who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'.||participants|||Number
780395|NCT00803101|Secondary|Percentage of Participants Who Received Red Blood Cells|Red blood cells were PRBCs and whole blood|From the start of surgery until 24 h after the start of surgery|The ITT-E population included all randomized participants who had received any study product, underwent the intended surgical procedure, and had an international normalized ratio INR > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.||percentage of participants|||Number
780396|NCT00803101|Secondary|Percentage of Participants With INR Correction at Various Times After the Start of Infusion|The time taken from the start of infusion to INR correction (defined as an INR ≤ 1.3) was recorded. The percentage of participants with INR correction was calculated at 0.5, 1, 3, 6, 12, and 24 h after the start of infusion.|From the start of infusion until INR correction; calculated at 0.5, 1, 3, 6, 12, and 24 h after the start of infusion|The ITT-E population included all randomized participants who had received any study product, underwent the intended surgical procedure, and had an international normalized ratio INR > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.||percentage of participants|||Number
780397|NCT00803101|Secondary|Transfusion of Packed Red Blood Cells (PRBCs) or Whole Blood|The total units of transfused PRBCs or whole blood|From the start of surgery until 24 h after the start of surgery|The ITT-E population included all randomized participants who had received any study product, underwent the intended surgical procedure, and had an international normalized ratio INR > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.||units of PRBCs or whole blood||Standard Deviation|Mean
780398|NCT00803101|Secondary|Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein S|Plasma levels are presented as the percentage of normal at pre-infusion and 30 min and 24 h after the start of infusion. The plasma level assay results are reported as a potency relative to a standard, where 100% is considered to be normal.|From pre-infusion until 24 h after the start of infusion|The ITT-E population included all randomized participants who had received any study product, underwent the intended surgical procedure, and had an international normalized ratio INR > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.||percentage of normal||Standard Deviation|Mean
780399|NCT00803101|Primary|Percentage of Participants Who Had a Rapid Decrease of the INR|A rapid decrease of the INR was defined as an INR ≤ 1.3 at 30 minutes after the end of infusion. The INR is a standard way to describe the time it takes for blood to clot; an INR range of 0.8 to 1.2 is considered normal for a healthy person who is not using oral anticoagulant therapy.|30 minutes after the end of infusion|The ITT-E population included all randomized participants who had received any study product, underwent the intended surgical procedure, and had an international normalized ratio INR > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.||percentage of participants||95% Confidence Interval|Number
780415|NCT00803283|Secondary|Patient's Global Assessment on Effectiveness|Participants will evaluate effectiveness by providing rating on the question “‘what is your rating of the overall effectiveness of the study medication during the titration or maintenance phase” using 5-point scale ranging from 1 to 5, where 1=poor,. 2=fair, 3=good, 4=very good and 5=excellent.|Day 14, Day 22 and Day 28|Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized.|||||
780400|NCT00803101|Primary|Percentage of Participants Achieving Hemostatic Efficacy During Surgery|"Hemostatic efficacy was rated as excellent, good, or poor/none, based on prespecified definitions. Hemostatic efficacy was the binary endpoint of effective or non-effective hemostasis, where 'effective' was a hemostatic efficacy rating of excellent or good, and 'non-effective' was a hemostatic efficacy rating of poor/none."|From the start of infusion until the end of surgery|The Intention-to-Treat Efficacy ITT-E population included all randomized participants who had received any study product, underwent the intended surgical procedure, and had an INR > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.||percentage of participants||95% Confidence Interval|Number
780401|NCT00803114|Secondary|Side Effects|Number of participants with pruritus, nausea and vomiting, urinary retention, drowsiness in the first 24 hours postpartum|at 24 hours postpartum||||||
780402|NCT00803114|Secondary|Maternal Satisfaction With Perineal Pain Management|"5 point Likert scale asking for agreement with the statement I was satisfied with my pain relief for the pain in my bottom during the first day after delivery. Scale ranged from strongly disagree to strongly agree."|at 24 hours postpartum|||participants|||Number
780403|NCT00803114|Secondary|Maternal Visual Analogue Scale (VAS) Score at Time of Request for First Additional Analgesic|"Participants were asked to indicate on a 10 cm line the point at which their perineal pain scored between one end anchored with no pain in my bottom to the other end anchored with the worst pain in my bottom that I can imagine"|by 24 hours postpartum|||scores on a scale||Standard Deviation|Mean
780404|NCT00803114|Secondary|Time to First Request for Analgesia|All participants requested analgesia at least once during their hospitalization|Hours|||hours||Standard Deviation|Mean
780405|NCT00803114|Primary|The Number of Women Who Received Systemic Narcotic Analgesics in the First 24 Hours Postpartum||24 hours postpartum|Analysis by intention to treat.||participants|||Number
780406|NCT00803179|Secondary|Evaluate Overall Quality of Life (QOL) in Adults With CF Related Wasting Treated With GH Therapy||14 months||||||
780407|NCT00803179|Primary|Measure Change in Weight in Adults With Cystic Fibrosis (CF) Related Wasting Following Growth Hormone (GH) Therapy||14 months||||||
780408|NCT00803244|Post-Hoc|Combined Score (CS)|"The daily Combined Score (CS) is a patient specific score taking into account the patient’s daily Rhinoconjunctivis Total Symptom Score (RTSS) and daily Rescue Medication Score (RMS), assuming equivalent importance of symptoms and rescue medication scores.
The RMS (range 0-3) is derived as follows: 0, no rescue medication; 1, use of antihistamine; 2, use of nasal corticosteroid; 3, use of oral corticosteroid. The RTSS (range 0-18) is the sum of the 6 individual rhinoconjunctivitis symptom score (each symptom is scored as follows: 0: no symptoms, 1: mild symptoms, 2: moderate symptoms and 3: severe symptoms).
The CS (range 0-3) = (RTSS/6 + RMS)/2. The lower the score, the better the outcome."|Pollen period (average of 32.1 days)|The Full Analysis Set included all patients who received at least one dose of the investigational product and had at least one Combined Score during the pollen period while on treatment.||Units on a scale (range: 0 to 3)||Standard Error|Least Squares Mean
780409|NCT00803244|Primary|Average Adjusted Symptom Score (AAdSS)|"The Adjusted Symptom Score (AdSS) is a subject-specific symptom score which is adjusted for rescue medication use.
Participants assessed daily, during the pollen period while on treatment, 6 rhinoconjunctivitis symptoms (sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes) each symptom is scored as follows: 0: no symptoms, 1: mild symptoms, 2: moderate symptoms, 3: severe symptoms. The sum of the 6 symptoms is the Rhinoconjunctivitis Total Symptom Score (RTSS) (range 0-18). If the subject took rescue medication on a given day, the AdSS equals the RTSS of that day or the AdSS of the day before, whichever is higher. This adjustment applies to the day of rescue medication use and the following day. Like the RTSS, the AdSS ranges from 0 to 18. The lower the score, the better the outcome."|Pollen period (average of 32.1 days)|The Full Analysis Set included all patients who received at least one dose of the investigational product and had at least one Adjusted Symptom Score during the pollen period while on treatment.||Units on a scale (range: 0 to 18)||Standard Error|Least Squares Mean
780410|NCT00803270|Secondary|Optimal Outcome of Treatment at 3 Months|"Composite measure defined as much better or very much better om PGI-I and normal or mild on PGI-S. PGI-I is a single item: Circle the one answer that best describes how your urinary tract condition is now, compared with how it was before your incontinence treatment with responses ranging from 1=Very much better to 7=Very much worse. PGI-S is a single items: Circle the one number that best describes how your urinary tract condition is now with responses ranging from 1=Normal to 4=Severe."|3 months|Participants who attended 3 month follow-up visit||participants|||Number
780411|NCT00803270|Primary|Optimal Outcome of Treatment at 6 Months|"Composite measure defined as much better or very much better on Patient Global Impression of Improvement (PGI-I) and normal or mild on Patient Global Impression of Symptoms (PGI-S). PGI-I is a single item: Circle the one answer that best describes your urinary tract condition now, compared to how it was before your incontinence treatment with responses ranging from 1= Very much better to 7= Very much worse. The PGI-S is a single item:; Circle the one number that best describes how your urinary tract condition is now with responses ranging from 1 = Normal to 4 Severe."|6 Months|Participants who attended 6 month follow-up visit||participants|||Number
780412|NCT00803283|Secondary|Mean Total Daily Dose (TDD) of Study Medication|Mean total daily dose of study medication taken during study will be recorded by participants.|Baseline up to day 28|Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized.|||||
780413|NCT00803283|Secondary|Number of Times the Pain Medication Required for Breakthrough Pain|The requirement of breakthrough pain medication will be recorded by participants. Morphine HCl, 10 mg, will be used as rescue medication for breakthrough pain.|Baseline up to Day 28|Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized.|||||
780414|NCT00803283|Secondary|Investigator's Global Assessment on Effectiveness|Investigator will evaluate effectiveness by providing rating on the question “‘what is your rating of the overall effectiveness of the study medication during the titration or maintenance phase” using 5-point scale ranging from 1 to 5, where 1=poor,. 2=fair, 3=good, 4=very good and 5=excellent.|Day 14, Day 22 and Day 28|Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized.|||||
780416|NCT00803283|Secondary|"BPI Questionnaire Item Pain Interference Score"|"The BPI is a questionnaire designed to assess the severity and impact of pain on quality of life. Total score ranges from 0=no pain to 10=extreme pain. BPI questionnaire Item Pain Interference will be assessed using the BPI questionnaire. Pain interference of general activity, mood, walking ability, normal work, relationships with others, sleep, and enjoyment of life will be rated on a scale ranging from 0 (no interference) to 10 (complete interference)."|Baseline, Day 14, Day 22 and Day 28|Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized.|||||
780417|NCT00803283|Secondary|"BPI Questionnaire Item Pain Relief Score"|"The BPI is a questionnaire designed to assess the severity and impact of pain on quality of life. Total score ranges from 0=no pain to 10=extreme pain. BPI questionnaire Item Pain Relief will be assessed using the BPI questionnaire. Pain relief was rated on a scale ranging from 0% (no relief) to 100% (complete relief)."|Baseline, Day 14, Day 22 and Day 28|Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized.|||||
780418|NCT00803283|Secondary|"BPI Questionnaire Item Pain Intensity Score"|"The BPI is a questionnaire designed to assess the severity and impact of pain on quality of life. Total score ranges from 0=no pain to 10=extreme pain. BPI questionnaire Item Pain Intensity will be assessed using the BPI questionnaire, score ranges from 0 (no pain) to 10 (pain as bad as you can imagine)."|Baseline, Day 14, Day 22 and Day 28|Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized.|||||
780419|NCT00803283|Secondary|"BPI Questionnaire Item 6 How Much Pain You Have Right Now Score"|"The BPI is a questionnaire designed to assess the severity and impact of pain on quality of life. Total score ranges from 0=no pain to 10=extreme pain. BPI questionnaire Item 6 how much pain you have right now will be assessed using the BPI questionnaire, score ranges from 0 (no pain) to 10 (pain as bad as you can imagine)."|Baseline, Day 14, Day 22 and Day 28|Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized.|||||
780420|NCT00803283|Primary|"BPI Questionnaire Item 3 Worst Pain Score at Day 28"|"The BPI is a questionnaire designed to assess the severity and impact of pain on quality of life. Total score ranges from 0=no pain to 10=extreme pain. BPI questionnaire Item 3 Worst Pain will be assessed using the BPI questionnaire, score ranges from 0 (no pain) to 10 (pain as bad as you can imagine)."|Day 28|Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized.|||||
780421|NCT00803283|Primary|"Brief Pain Inventory (BPI) Questionnaire Item 3 Worst Pain Score at Day 14"|"The BPI is a questionnaire designed to assess the severity and impact of pain on quality of life. Total score ranges from 0=no pain to 10=extreme pain. BPI Questionnaire Item 3 Worst Pain will be assessed using the BPI questionnaire, score ranges from 0 (no pain) to 10 (pain as bad as you can imagine)."|Day 14|Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized.|||||
780422|NCT00803361|Secondary|Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score at Endpoint|A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.'|Baseline, Week 15|Participants with a baseline and at least one post-baseline result within each treatment group.||Units on a Scale||Standard Deviation|Mean
780423|NCT00803361|Secondary|Change From Baseline in Visual Analogue Scale (VAS) for Pain at Endpoint|VAS for pain consists of 6 questions that assess overall pain, headache, back pain, shoulder pain, pain interference with daily activities, and pain while awake. Participant rates pain on a 100 millimeter (mm) line between two anchors (0= no pain and 100=very severe pain).|Baseline, Week 15|Participants with a baseline and at least one post-baseline result within each treatment group.||Units on a Scale||Standard Deviation|Mean
780424|NCT00803361|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) at Endpoint, Global Functioning Scores|The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Total scores range from 0 to 30 with higher values indicating greater disruption in the patient's work/social/family life. Individual item scores range from 0-10, with higher numbers indicating greater disruption. Item 1 is for work/schoolwork, Item 2 is for social life/leisure activities, Item 3 is for family life/home responsibilities.|Baseline, Week 15|Participants with a baseline and at least one post-baseline value.||Units on a scale||Standard Deviation|Mean
780425|NCT00803361|Secondary|Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint|BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life.|Baseline, Week 15|Participants with a baseline and at least one post-baseline result within each treatment group.||Units on a Scale||Standard Deviation|Mean
780426|NCT00803361|Secondary|Mean Clinical Global Impressions (CGI) Improvement Score at Endpoint|Measures clinician's perception of patient improvement at the time of assessment compared with the start of treatment. Scores range from 1 (very much better) to 7 (very much worse).|Week 15|Participants with at least one post-baseline result within each treatment group.||Units on a Scale||Standard Deviation|Mean
780427|NCT00803361|Secondary|Change From Baseline in the Hamilton Anxiety (HAMA) Rating Scale Total Score at Endpoint|The HAMA scale measures anxiety symptoms accompanying Major Depressive Disorder (MDD). Each item of the 14-item HAMA was scored from 0 (not present) to 4 (very severe), with a resulting maximum total score of 56.|Baseline, Week 15|Participants with a baseline and at least one post-baseline result within each treatment group.||Units on a scale||Standard Deviation|Mean
780443|NCT00803634|Secondary|Number of Patients That Require Intubation During Study Drug Administration up to 96 Hours|The number of patients requiring intubation was calculated based on the total number of mITT patients.|Initiation through termination of study drug (up to 96 hours)|mITT population: All randomized and eligible patients who were dosed with study drug and have a baseline SBP ≥160 mm Hg, at least one post-baseline on-treatment SBP measurement, and a confirmed diagnosis of AHF||Patients|||Number
780428|NCT00803361|Primary|Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score at Endpoint|A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.'|Baseline, Week 15|Participants with a baseline and at least one post-baseline result within each treatment group.||Units on a scale||Standard Deviation|Mean
780429|NCT00803400|Secondary|Participants´Endpoint Change From Baseline in Clinical Global Impression Improvement Scale (CGI-I)|The Clinical Global Impression Improvement Scale is a 7 point ordinal scale that assesses how much the patient's illness has improved or worsened relative to a baseline state before the intervention. Rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.|Baseline and 12 weeks|For this outcome the baseline number of participants is zero as at the first visit patients have not received any treatment yet, thus they cannot be assessed with a scale that measures improvement at their first visit. This scale will only be applied along weeks 2, 4, 8, and 12, after patients have received their corresponding treatments.||Units on a scale||Standard Deviation|Mean
780430|NCT00803400|Secondary|Participants´Endpoint Change From Baseline in Clinical Global Impression Severity Scale (CGI-S)|The Clinical Global Impression Severity scale is a 7 point ordinal scale that rates the severity of the patient's illness, assessing on the severity of a patient’s mental illness. It ranges from 1 to 7 (1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; 7, extremely ill).|Baseline and 12 weeks|||Units on a scale||Standard Deviation|Mean
780431|NCT00803400|Primary|Participants´Endpoint Change From Baseline in Hamilton Anxiety Rating Scale|The Hamilton Anxiety Rating Scale is a test that consists of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe).|Baseline and 12 weeks|||Units on a scale||Standard Deviation|Mean
780432|NCT00803413|Primary|Intensity of Low Back Pain (LBP) Self-Estimated by Visual Analogical Scale (VAS)|Patients were asked to indicate their perception about their LBP intensity with a cross on a line without marks, ranging from 1 (very light pain) through 10 (very strong pain)|6 months|||milimeters||Standard Deviation|Mean
780433|NCT00803413|Secondary|Spine Flexibility (3rd Fingertip to Floor – 3FF).|Patients in up-right position with joined feet and stretched out arms were asked to bend the spine as much as possible without bending the knees; the least achieved distance between the 3rd fingertip and the floor was measured in centimeters with a proper rule.|6 months|||centimeters||Standard Deviation|Mean
780434|NCT00803517|Secondary|Best Corrected Visual Acuity|Best-corrected visual acuities were obtained with Snellen charts. Snellen’s visual acuity was converted logarithm of the minimum angle of resolution (logMAR) for statistical analysis.|baseline, 1 month, 3 months, 6 months|||logMAR||Standard Deviation|Mean
780435|NCT00803517|Primary|Multifocal Electroretinogram Amplitudes|"Amplitude at first annular ring at multifocal electroretinogram RETIscan (Roland Consult, Wiesbaden, Germany) is used for multifocal retinogram.
The recording protocol was chosen according to the International Society for Clinical Electro-physiology of Vision (ISCEV) guidelines."|baseline, 1 month, 3 months, 6 months|||microvolts||Standard Deviation|Mean
780436|NCT00803543|Primary|Rate of Asymptomatic HSV-2 Genital Shedding|Proportion of days on which HSV shedding was observed. This part of the study was performed in a subset of participants (N = 34). Participant collected daily genital specimens for 8 weeks starting at week 16 and continuing through week 24 of the study.|24 weeks|||Proportion of days|Total Number of Days Assessed||Number
780437|NCT00803543|Primary|Number of Participants With an HIV Viral Load of <500 Copies/ml|Number of participants with an HIV Viral Load of <500 copies/ml at 24 weeks|24 weeks|||Participants|||Number
780438|NCT00803543|Primary|CD4 Count|CD4 count as measured after 24 weeks of placebo versus valacyclovir. Reports as cells/ml|24 weeks|||cells/ml||Full Range|Mean
780439|NCT00803543|Primary|Herpes Simplex Virus Type 2 Recurrence|Number of recurrences of genital herpes|24 Weeks|No participants reported genital herpes recurrence during the study.||Recurrence|||Number
780440|NCT00803595|Secondary|Time for Body Temperature to Return to Normal|Time for return to normal axillary temperature was was defined as the time until the beginning of the first 21.5-hour period in which the axillary temperature returned to 36.9°C. Patients recorded their axillary temperature 4 times daily for 15 days. Patients whose axillary temperature had not been returned to 36.9°C at the time of their withdrawal from the study or at the end of the observation period were censored.|15 days|||hours||95% Confidence Interval|Median
780441|NCT00803595|Primary|Time to Alleviation of Influenza Illness|The time to illness alleviation which was defined as the time from the initiation of trial treatment to the beginning of the first 21.5-h period in which all influenza symptoms were “absent” or “mild.” Patients recorded their severity of influenza symptoms (headache, myalgia/arthralgia, fatigue, chills/sweats, nasal symptom, sore throat, and cough) 4 times daily for 15 days. Patients whose influenza symptoms had not been alleviated at the time of their withdrawal from the study or at the end of the observation period were censored.|15 days|Full analysis set (FAS) was defined as the set of subjects who had a positive test result using the influenza rapid diagnostic kit, received at least 1 dose of the study drug, and had valid efficacy data.||hours||95% Confidence Interval|Median
780442|NCT00803634|Primary|Percentage to First Achieve Initial Prespecified SBP Target Range [≥20 mm Hg and ≤40 mm Hg Apart] and 15% Reduction From Baseline Within First 30 Minutes|Analysis of the percentage of patients achieving both components of this composite endpoint (attainment of the initial prespecified SBP target range and a 15% reduction in SBP from baseline) was calculated within each treatment group using the number of mITT patients achieving the SBP reduction goal divided by the number of mITT patients, and multiplied by 100.|Initiation of study drug through the initial 30-minutes|mITT population: All randomized and eligible patients who were dosed with study drug and have a baseline SBP ≥160 mm Hg, at least one post-baseline on-treatment SBP measurement, and a confirmed diagnosis of AHF||Percentage of patients||95% Confidence Interval|Number
780465|NCT00803712|Secondary|Subject Incidence of Hypercalcemia During the Maintenance Phase|Hypercalcemia is defined as at least one corrected serum calcium value >= 10.2 mg/dL|Weeks 26-48|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started, and also had at least one corrected serum calcium value during the time period of interest.||participants|||Number
780444|NCT00803634|Secondary|Percentage of Patients With at Least One Episode of SBP < 90 mm Hg During Study Drug Administration (up to 96 Hours)|The percent of patients with at least one episode of SBP <90 mm Hg was calculated as the number of mITT patients who had at least one episode of SBP<90 mm Hg during study drug administration up to 96 hours divided by mITT patients, and multiplied by 100 for each treatment group.|Initiation through termination of study drug (up to 96 hours)|Safety population: All randomized and eligible patients who were dosed with study drug.||Percentage of patients||95% Confidence Interval|Number
780445|NCT00803634|Secondary|Percentage of Patients Who Received Any Alternative IV Antihypertensive Drug at Any Time During Study Drug Treatment|The percentage of patients who received any alternative IV antihypertensive drug at any time during the study drug treatment period (up to 96 hours) was calculated using mITT patients within each treatment group.|Initiation through termination of study drug (up to 96 hours)|mITT population: All randomized and eligible patients who were dosed with study drug and have a baseline SBP ≥160 mm Hg, at least one post-baseline on-treatment SBP measurement, and a confirmed diagnosis of AHF||Percentage of patients||95% Confidence Interval|Number
780446|NCT00803634|Secondary|Time to Use Other IV Antihypertensives During the Study Drug Administration|The length of time to use other IV antihypertensive agents was defined as the duration in hours from the initiation of study drug through the time when any other concomitant IV antihypertensive agent was administered, thus, representing the time period without use of any other concomitant IV antihypertensive agent. Median time to use other IV antihypertensive agents was obtained using Kaplan-Meier method. If a patient did not receive any concomitant IV antihypertensive during the 96-hour treatment period, this patient was considered censored at 96 hours. If study drug was stopped less than 96 hours and the patient has no concomitant IV antihypertensive agent, the patient was considered censored when study drug was stopped.|Initiation of study drug through any other concomitant IV antihypertensive agent administered, up to 96 hours|mITT population: All randomized and eligible patients who were dosed with study drug and have a baseline SBP ≥160 mm Hg, at least one post-baseline on-treatment SBP measurement, and a confirmed diagnosis of AHF||Hours||95% Confidence Interval|Median
780447|NCT00803634|Secondary|Change From Baseline in Dyspnea (Measured By VAS) at Each Time Point|A validated visual analog scale (VAS) with a horizontal ruler showing increments from 0 to 100 mm with 0 = Best and 100 = Worst was used. The test was asked from the patient's perspective and had to be administered with patient sitting. Relative change in VAS from baseline is the value at each time point minus the baseline value. Relative change from baseline was summarized descriptively (with associated two-tailed 95% CIs of the mean values) at 15, 30 and 45 minutes and at 1, 2, 3 hours and 12 hours, and 1 hour post termination of study drug treatment.|Baseline (immediately prior to study drug administration) through 1 hour after study drug termination|mITT population: All randomized and eligible patients who were dosed with study drug and have a baseline SBP ≥160 mm Hg, at least one post-baseline on-treatment SBP measurement, and a confirmed diagnosis of AHF||millimeters (mm)||Standard Deviation|Mean
780448|NCT00803634|Secondary|Percentage Falling Below Lower Limit of SBP Target Range at Any Time During Study|The percentage of patients in whom the SBP fell below the lower limit of the prespecified target range at any time during the entire study drug treatment period (up to 96 hours) was calculated within each treatment group using the number of mITT patients achieving the endpoint divided by the number of mITT patients and multiplied by 100. Two-tailed 95% CIs were computed for these percentages.|Initiation through termination of study drug (up to 96 hours)|mITT population: All randomized and eligible patients who were dosed with study drug and have a baseline SBP ≥160 mm Hg, at least one post-baseline on-treatment SBP measurement, and a confirmed diagnosis of AHF||Percentage of patients||95% Confidence Interval|Number
780449|NCT00803634|Secondary|Percentage Falling Below Lower Limit of SBP Target Range Within First 30 Minutes|The percentage of patients in whom the SBP fell below the lower limit of the prespecified target range at any time during the first 30 minutes was calculated within each treatment group using the number of mITT patients achieving the endpoint divided by the number of mITT patients and multiplied by 100. Two-tailed 95% CIs were computed for these percentages.|Initiation of study drug through the initial 30-minutes|mITT population: All randomized and eligible patients who were dosed with study drug and have a baseline SBP ≥160 mm Hg, at least one post-baseline on-treatment SBP measurement, and a confirmed diagnosis of AHF||Percentage of patients||95% Confidence Interval|Number
780450|NCT00803634|Secondary|SBP Area Under the Curve (AUC) Outside Prespecified Target Range|The magnitude and duration of SBP excursions was calculated as the area under the curve (AUC) for each patient, using the trapezoidal rule, related to time (in minutes) that each patient’s SBP was outside the target range. AUC was determined based on data collected from the initiation of study medication through the end of monotherapy treatment up to 96 hours, normalized per hour, and expressed as mmHg × minute/hour.|Initiation of study drug through end of monotherapy (up to 96 hours)|mITT population: All randomized and eligible patients who were dosed with study drug and have a baseline SBP ≥160 mm Hg, at least one post-baseline on-treatment SBP measurement, and a confirmed diagnosis of AHF||mm Hg x min/h||Standard Deviation|Mean
780451|NCT00803634|Secondary|Percentage Reaching Prespecified Target Range Without Falling Below Lower Limit of Target Range Within First 30 Minutes|The percentage of patients reaching this endpoint was calculated within each treatment group using the number of mITT patients reaching the endpoint divided by the number of mITT patients, and multiplied by 100. Two-tailed 95% CIs were computed for these percentages.|Initiation of study drug through the initial 30-minutes|mITT population: All randomized and eligible patients who were dosed with study drug and have a baseline SBP ≥160 mm Hg, at least one post-baseline on-treatment SBP measurement, and a confirmed diagnosis of AHF||Percentage of patients||95% Confidence Interval|Number
780466|NCT00803712|Secondary|Subject Incidence of Hypercalcemia During the Efficacy Assessment Phase at Month 6|Hypercalcemia is defined as at least one corrected serum calcium value >= 10.2 mg/dL|Weeks 22-26|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started, and also had at least one corrected serum calcium value during the time period of interest.||participants|||Number
780499|NCT00803751|Primary|Quality of Laryngeal View Obtained on Comarck Lehane Classification|The view obtained when we do laryngoscopy. The Comarck Lehane classification is as follows: 1) Most of the glottis is seen; 2a) Only the posterior part of the glottis is visible; 2b) The epiglottis is visible, but none of the glottis can be seen; 3) Not even the epiglottis is visible.|during laryngoscopy prior to intubation. Few minutes before intubation|||Participants|||Number
780452|NCT00803634|Primary|Time to First Achieve Initial Prespecified SBP Target Range and 15% Reduction From Baseline Within First 30 Minutes|Time to first achieve the initial pre-specified systolic blood pressure (SBP) target range and a 15% SBP reduction from baseline is the time in minutes between the initiation of study medication and the time the patient first achieved both components. Median time was estimated using Kaplan Meier method. 95% two-sided confidence interval of the median time is from 'Simon and Lee, 1982'. If patients did not reach both components within 30 minutes from the initial treatment with study medication, or another antihypertensive agent was administered, the patient was censored at 30 minutes or the time when another antihypertensive agent is given, whichever came first.|Initiation of study drug through the initial 30-minutes|mITT population: All randomized and eligible patients who were dosed with study drug and have a baseline SBP ≥160 mm Hg, at least one post-baseline on-treatment SBP measurement, and a confirmed diagnosis of AHF||Minutes||95% Confidence Interval|Median
780453|NCT00803647|Secondary|Recurrence-free Survival (RFS). Time From Study Entry Until First Recurrence.||2 years|Patients with R0 resection||months||95% Confidence Interval|Median
780454|NCT00803647|Secondary|Objective Clinical Response Rate (cRR). Measureable Lesions That Can be Accurately Measured in at Least One Dimension With Conventional Radiologic Techniques or Spiral CT.|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by PET/CT, CT scan, MRI or spiral CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective clinical Response Rate (cRR) = CR + PR during the 3 preoperative cycles, among the treated patients.|8 months|||percentage of participants||95% Confidence Interval|Number
780455|NCT00803647|Secondary|Overall Survival (OS). Time From Study Entry Until Death From Any Cause.||3 years||||||
780456|NCT00803647|Primary|Reported Adverse Events.|19 participants experienced at least one adverse event. There were a total of 95 adverse events reported. (Note: multiple occurrences of the same adverse event in one individual are counted only once.) Refer to the Adverse Events section for specifics. The Other Adverse Events section lists only those events occurring above 5% frequency.|8 months|||adverse events|||Number
780457|NCT00803647|Primary|The Percentage of Patients Who Had a Curative (R0) Liver Metastasectomy Following Protocol Treatment, i.e., Metastatic Disease That Can be Completely Resected and/or Ablated With no Postoperative Evidence of Residual Malignant Disease (R0 Resection).||8 months|All 20 patients were included in this outcome measure.||percentage of participants||95% Confidence Interval|Number
780458|NCT00803686|Secondary|AUCInhibition=Hours*%P|The AUCinhibition, (Area Under the Inhibition Curve) in hours*%inhibition vs placebo under the baseline line over the curve.|12 Hours|||hours*%P||Standard Deviation|Mean
780459|NCT00803686|Secondary|Derived Pharmacodynamic Parameters Further Characterizing the Effects of Oral or Intranasal Calcitonin on Plasma CTx-1, Given at Night to Post-menopausal Women|See Primary Outcome description. These CTx-1 plasma concentrations were collected over 12 hours, the values seen following active were compared with the time-matched individual values following placebo and used to derive the pharmacodynamic parameters. The primary was Rmin, seen above, and the Secondary ones were the time to that Rmin (Tmin) and the total time from the beginning of the inhibition to the end of the effect or the end of the study period (Tinhibition).|12 hours|Data from Part 1 (crossover Periods 1 and 2) were pooled to give CTx-1 mean data for the oral rsCT tablet group (n = 12) and for the oral placebo group n = 12). Part 2, open-label, non-crossover, compared the CTx-1 results after oral rsCT (n = 5) with those after Fortical(n = 4. The % inhibition is reported first.||Hours||Standard Deviation|Mean
780460|NCT00803686|Primary|Pharmacodynamic Effect of Oral Calcitonin|C-terminal telopeptide of Collagen Type I (CTx-1) is an established plasma biomarker employed as an index of bone-resorption activity in response to interventions such as an anti-resorptive agent such as calcitonin. Here the calcitonin-salmon is rsCT, (recombinant) both oral and intranasal. These CTx-1 plasma concentrations were collected over 12 hours post-dosing where each subject served as her own control, as all received placebo in this crossover study, to account for the known diurnal variation of plasma CTx-1. For each time point, the ratio of the calcitonin response over the placebo response for that subject was derived from the plasma levels of CTx-1 and reported as a % of the placebo response (% Placebo or %P). These values were used to determine the primary pharmacodynamic parameter of Rmin, the minimum value seen following each active dose. The same %P values were used to derive the secondary pharmacodynamic parameters described in Secondary outc|12 hr|Not applicable. All participants who received treatment were included.||percentage of time-matched placebo respo||Standard Deviation|Mean
780461|NCT00803712|Secondary|Subject Incidence of Hyperphosphatemia During the Efficacy Assessment Phase at Month 12|Hyperphosphatemia is defined as at least one serum phosphorus value >= 5.5 mg/dL|Weeks 48-52|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started, and also had at least one serum phosphorus value during the time period of interest.||participants|||Number
780462|NCT00803712|Secondary|Subject Incidence of Hyperphosphatemia During the Maintenance Phase|Hyperphosphatemia is defined as at least one serum phosphorus value >= 5.5 mg/dL|Weeks 26-48|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started, and also had at least one serum phosphorus value during the time period of interest.||participants|||Number
780463|NCT00803712|Secondary|Subject Incidence of Hyperphosphatemia During the Efficacy Assessment Phase at Month 6|Hyperphosphatemia is defined as at least one serum phosphorus value >= 5.5 mg/dL|Weeks 22-26|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started, and also had at least one serum phosphorus value during the time period of interest.||participants|||Number
780464|NCT00803712|Secondary|Subject Incidence of Hypercalcemia During the Efficacy Assessment Phase at Month 12|Hypercalcemia is defined as at least one corrected serum calcium value >= 10.2 mg/dL|Weeks 48-52|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started, and also had at least one corrected serum calcium value during the time period of interest.||participants|||Number
780497|NCT00803751|Secondary|Time Taken for Intubation||throughout the intubation procedure|||seconds||Standard Deviation|Mean
780498|NCT00803751|Primary|Number of Intubation Attempts|Number of participants with the indicated number of intubation attempts (1/2/3)|during intubation prior to surgery|||Participants|||Number
780467|NCT00803712|Secondary|Summary of Percent Change From Baseline in Serum Phosphorus at Month 12 Efficacy Assessment Phase|All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 48-52|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a serum phosphorus value during the efficacy assessment phase||percent change||95% Confidence Interval|Least Squares Mean
780468|NCT00803712|Secondary|Summary of Serum Phosphorus (mg/dL) at Month 12 Efficacy Assessment Phase|All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 48-52|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a serum phosphorus value during the efficacy assessment phase||mg/dL||95% Confidence Interval|Least Squares Mean
780469|NCT00803712|Secondary|Summary of Percent Change From Baseline in Serum Phosphorus at Month 6 Efficacy Assessment Phase|All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 22-26|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a serum phosphorus value during the efficacy assessment phase||percent change||95% Confidence Interval|Least Squares Mean
780470|NCT00803712|Secondary|Summary of Serum Phosphorus (mg/dL) at Month 6 Efficacy Assessment Phase|All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 22-26|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a serum phosphorus value during the efficacy assessment phase||mg/dL||95% Confidence Interval|Least Squares Mean
780471|NCT00803712|Secondary|Summary of Percent Change From Baseline in Corrected Serum Calcium at Month 12 Efficacy Assessment Phase|All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 48-52|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a corrected serum calcium value during the efficacy assessment phase||percent change||95% Confidence Interval|Least Squares Mean
780472|NCT00803712|Secondary|Summary of Corrected Serum Calcium (mg/dL) at Month 12 Efficacy Assessment Phase|All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 48-52|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a corrected serum calcium value during the efficacy assessment phase||mg/dL||95% Confidence Interval|Least Squares Mean
780473|NCT00803712|Secondary|Summary of Percent Change From Baseline in Corrected Serum Calcium at Month 6 Efficacy Assessment Phase|All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 22-26|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a corrected serum calcium value during the efficacy assessment phase||percent change||95% Confidence Interval|Least Squares Mean
780474|NCT00803712|Secondary|Summary of Corrected Serum Calcium (mg/dL) at Month 6 Efficacy Assessment Phase|All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 22-26|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a corrected serum calcium value during the efficacy assessment phase||mg/dL||95% Confidence Interval|Least Squares Mean
780475|NCT00803712|Secondary|Summary of Percent Change From Baseline in iPTH (pg/mL) at Month 12 Efficacy Assessment Phase|All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 48-52|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without an iPTH value during the efficacy assessment phase||percent change||95% Confidence Interval|Least Squares Mean
780476|NCT00803712|Secondary|Summary of iPTH (pg/mL) at Month 12 Efficacy Assessment Phase|All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 48-52|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without an iPTH value during the efficacy assessment phase||pg/mL||95% Confidence Interval|Least Squares Mean
780477|NCT00803712|Secondary|Summary of Percent Change From Baseline in iPTH (pg/mL) at Month 6 Efficacy Assessment Phase|All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 22-26|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without an iPTH value during the efficacy assessment phase||percent change||95% Confidence Interval|Least Squares Mean
780478|NCT00803712|Secondary|Summary of iPTH (pg/mL) at Month 6 Efficacy Assessment Phase|All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 22-26|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without an iPTH value during the efficacy assessment phase||pg/mL||95% Confidence Interval|Least Squares Mean
780479|NCT00803712|Secondary|Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52)|All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 22-26 and Weeks 48-52|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a serum phosphorus value during the efficacy assessment phases||participants|||Number
780480|NCT00803712|Secondary|Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52)|All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 22-26 and Weeks 48-52|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a corrected serum calcium value during the efficacy assessment phases||participants|||Number
780481|NCT00803712|Secondary|Achievement of a Mean iPTH <=300 pg/mL During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52)|All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 22-26 and Weeks 48-52|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without an iPTH value during the efficacy assessment phases||participants|||Number
780482|NCT00803712|Secondary|Achievement of a >= 30% Reduction in Mean iPTH From Baseline to During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52)|All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 22-26 and Weeks 48-52|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without an iPTH value during the efficacy assessment phases||participants|||Number
780483|NCT00803712|Secondary|Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52)|All available measurements from the efficacy assessment phase (EAP) at month 12 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 48-52|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a serum phosphorus value during weeks 48-52||participants|||Number
780484|NCT00803712|Secondary|Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)|All available measurements from the efficacy assessment phase (EAP) at month 6 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 22-26|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a serum phosphorus value during weeks 22-26||participants|||Number
780485|NCT00803712|Secondary|Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52)|All available measurements from the efficacy assessment phase (EAP) at month 12 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 48-52|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a corrected serum calcium value during weeks 48-52||participants|||Number
780486|NCT00803712|Secondary|Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)|All available measurements from the efficacy assessment phase (EAP) at month 6 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 22-26|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a corrected serum calcium value during weeks 22-26||participants|||Number
780487|NCT00803712|Secondary|Achievement of a Mean PTH <= 300 pg/mL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52)|All available measurements from the efficacy assessment phase (EAP) at month 12 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 48-52|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without an iPTH value during weeks 48-52||participants|||Number
780488|NCT00803712|Secondary|Achievement of a ≥ 30% Reduction in Mean PTH From Baseline to During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52)|All available measurements from the efficacy assessment phase (EAP) at month 12 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 48-52|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without an iPTH value during weeks 48-52||participants|||Number
780489|NCT00803712|Secondary|Achievement of a Mean PTH <= 300 pg/mL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)|All available measurements from the efficacy assessment phase (EAP) at month 6 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 22-26|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without an iPTH value during weeks 22-26||participants|||Number
780490|NCT00803712|Primary|Achievement of a ≥ 30% Reduction in Mean PTH From Baseline to During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)|All available measurements from the efficacy assessment phase (EAP) at month 6 were used in the calculation of the mean over the period. For participants with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 22-26|Analysis based on the full analysis set, including all participants who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for participants without an iPTH value during weeks 22-26||participants|||Number
780491|NCT00803738|Secondary|Proportion of Subjects With Clinical Cure|"A subject was considered a clinical cure if all of the following were satisfied:
All signs and symptoms with a score of 1 (mild) or 2 (moderate) at the Screening/Baseline visit were absent (score = 0), and all signs or symptoms with a score of 3 (severe) at Screening/Baseline had a score of 0 or 1.
Total signs and symptoms did not worsen at any time following completion of the study treatment.
Any new sign or symptom observed during the study period was determined by the Investigator not to be related to VVC.
The subject did not require additional vulvovaginal or systemic antifungal therapy at any time during the study period.
The subject did not use any topical drug therapy other than the study medication for the treatment of vulvovaginal irritation and/or pruritus such as topical analgesic or corticosteroid products"|Visit 3: Day 22-31|per protocol population||participants|||Number
780492|NCT00803738|Secondary|Proportion of Subjects With Mycological Cure|Mycological cure was defined as a negative mycological culture (no growth) for Candida albicans or other relevant baseline yeast organism.|Visit 3: Day 22-31|Per protocol population||participants|||Number
780493|NCT00803738|Primary|Proportion of Subjects in Each Treatment Group With Therapeutic Cure|The primary efficacy measure was the proportion of subjects in each treatment group with a therapeutic cure at the Test-of-Cure visit (Visit 3). A subject was considered a therapeutic cure if the subject was a clinical cure with mycological cure.|Visit 3: Day 22-31|Per Protocol (PP) population||participants|||Number
780494|NCT00803751|Secondary|POGO Score With 2nd Laryngoscopy|POGO score is the percent of glottic opening observed during laryngoscopy. 100% POGO score indicates a full view of glottic opening and 0% POGO score indicates no glottic opening.|Before patient is intubated|||Score||Standard Deviation|Mean
780495|NCT00803751|Primary|Quality of Laryngeal View Obtained With 2nd Laryngoscopy|The view obtained when we do laryngoscopy. The Comarck Lehane classification is as follows: 1) Most of the glottis is seen; 2a) Only the posterior part of the glottis is visible; 2b) The epiglottis is visible, but none of the glottis can be seen; 3) Not even the epiglottis is visible.|during laryngoscopy prior to intubation (few minutes prior to intubation)|||Participants|||Number
780496|NCT00803751|Secondary|POGO Score With 1st Laryngoscopy|POGO score is the percent of glottic opening observed during laryngoscopy. 100% POGO score indicates a full view of glottic opening and 0% POGO score indicates no glottic opening.|Before patient is intubated (few minutes before intubation)|||Score||Standard Deviation|Mean
780500|NCT00803777|Secondary|Average Within Replicate Coefficient of Variation CV (Precision)|The average Coefficient of Variation (CV) was computed by calculating the square of the CV for each pair of Blood Glucose (BG) self-test results, averaging this square value over the number of subjects included in the analysis, and then taking the square root.|1-2 hours|Meter results were used from subject and HCP data that had numeric values for duplicate BG self-tests. One subject data set was not used because subject was given carbohydrate to prevent low blood sugar. Two subjects' meter results contained outliers (NCCLS EP-9A) and one HCP's results had only one replicate result so these sets were not analyzed.||percentage CV|||Number
780501|NCT00803777|Secondary|Number of Participants Rated as <=2 (Labeling Comprehension)|"Subjects or parents/guardians, as applicable, performed meter tasks after reading the User Guide and Quick Reference Guide. The study staff rated the participants on their success at performing the tasks as follows:
Successful in performing tasks correctly without assistance
Successful after study staff prompted participant to review User Guide.
Successful after study staff assisted subject. (Similar to review of a specific function during a Customer Service call.)
Subject did not perform task correctly and study staff intervention was required."|1-2 hours|For 2 different subjects, study staff did not rate subject success at 1 task.||participants|||Number
780502|NCT00803777|Secondary|Numbers of BG Results in Zones of the Parkes Error Grid of Clinical Significance of Inaccuracies|The Parkes Error Grid, developed from a survey of 100 clinicians, plots combinations of BG meter measurements against reference method results. Each (x,y) point on the grid is within a risk category, assigned by the clinicians surveyed. Risk categories (increasing severity): ZoneA: No effect on clinical action; ZoneB: Altered clinical action or little/no effect on clinical outcome; ZoneC: Altered clinical action likely to effect clinical outcome; ZoneD: Altered clinical action could have significant medical risk; ZoneE: Altered clinical action could have dangerous consequences|1-2 hours|Some subjects >=13 yrs consented to provide larger capillary samples for YSI glucose analysis. One subject's sample was insufficient to run the YSI analysis. Another subject’s results were not useable as the subject was given carbohydrate to prevent low blood sugar. Duplicate subject BG results provided 158 possible data points.||Number of BG results in zone (n=79x2)|||Number
780503|NCT00803777|Primary|Number of Duplicate Subject BGM Results Within +/- 15mg/dL or +/- 20% of Healthcare Professional Capillary Results|Duplicate subject Blood Glucose Monitoring System (BGMS) results were compared to healthcare professional (HCP) BGMS results (possible number of results = 292). The number of Subject BGM results within +/- 15mg/dL (for reference BG values <75mg/dL) and within +/- 20% (for reference BG values >= 75mg/dL)of the HCP results was calculated.|1-2 hours|One subject's results were not used because the subject was given carbohydrate to prevent low blood sugar.||number of Subject BGM Results (n=146x2)|||Number
780504|NCT00803777|Primary|Number of Duplicate Capillary Results Within +/- 15mg/dL or +/- 20% of Laboratory Glucose Method|Subjects with diabetes (or parents/guardians) and healthcare professionals (HCPs) used a new blood glucose monitoring system (BGMS) with subject capillary blood. BGM results were compared to a lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were obtained in duplicate from subjects(158 BG results possible). The number of capillary results within +/- 15mg/dL (for reference blood glucose values <75mg/dL) or +/- 20% (for reference blood glucose values >/= 75mg/dL)of the reference results were calculated.|1-2 hours|Some subjects >=13 years old consented to provide larger capillary samples for YSI glucose analysis. Subjects and HCPs provided duplicate results, but one subject's HCP provided only one glucose result. One subject sample was too small to run the YSI analysis; another subject was given carbohydrate to prevent low blood sugar (no results obtained)||number of capillary results (n=79x2)|||Number
780505|NCT00803790|Secondary|Part II : Maximum Concentration (Cmax) of Vitamin D|Serum vitamin D pharmacokinetic parameter was calculated for the following: maximum concentration of drug observed in serum (Cmax). Serum samples for determination of vitamin D concentrations were obtained at -2 and 0 hrs predose on Day 1 and at 2, 3, 5, 7, 9, 12, 16, 24, 36, 48, 72 and 80 hours post dose for each treatment period.|Day 1 across the 80-hour plasma collection period (Periods 1 and 2)|60 participants of the 67 enrolled in Part 2 were included in the statistical analysis. 7 participants that were enrolled, but did not complete both study periods were excluded.||ng/ml||Standard Deviation|Least Squares Mean
780506|NCT00803790|Primary|Part II: AUC (Area Under the Plasma Concentration-time Curve) of Vitamin D|The serum vitamin D pharmacokinetic parameter was calculated following the treatment of 70mg alendronate+5600 IU vitamin D combination tablet and 5600 IU vitamin D tablet on Day 1: area under the plasma concentration-time curve (AUC0-80hr). Serum samples for determination of vitamin D concentrations were obtained at -2 and 0 hrs predose on Day 1 and at 2, 3, 5, 7, 9, 12, 16, 24, 36, 48, 72 and 80 hours post dose for each treatment period.|Day 1 across the 80-hour plasma collection period (Period 1 and 2)|60 participants of the 67 enrolled in Part 2 were included in the statistical analysis. 7 participants that were enrolled, but did not complete both study periods were excluded.||ng*hr/mL||Standard Deviation|Least Squares Mean
780507|NCT00803790|Primary|Part 1: Urinary Excretion of Alendronate|Bioequivalence was demonstrated by measuring the total urinary excretion of alendronate which was determined over a 36-hour period following single dose administration of 70-mg alendronate+5600 International Units (IU) vitamin D combination tablet and 70mg alendronate tablet alone. Urine for each treatment period was collected at –2 to 0 hours predose, 0 to 8, 8 to 24, and 24 to 36 hours postdose on Days 1 and 2.|Day 1-2 across the 36 hour urinary collection period (Periods 1 and 2)|220 participants of the 251 enrolled in Part 1 were included in the statistical analysis. 31 participants were excluded: 23 were enrolled but did not complete both study periods and 8 participants had incomplete urine profiles in one or both periods.||μg||Standard Deviation|Least Squares Mean
780508|NCT00803959|Secondary|Stress Test at 12 Mos|A provocative stress test at a bladder volume of 300 ml was performed for direct observation of urine leakage. Observed urine loss from the urethra coincidental with the Valsalva maneuver or cough was considered a positive test. The stress test was not performed by the study surgeon but rather by an outcome assessor who was unaware of the study assignments.|Screen and 12 months|There were 315 women randomized to each arm. In the UDS arm, 43 did not have primary outcome data leaving 272 in the intention-to-treat group. In the no UDS arm, 49 did not have primary outcome data leaving 266 in the ITT group. Of these, only 225 in the UDS arm and 222 in the no UDS had stress test data at 12 months.||percentage of participants|||Number
785023|NCT00834626|Primary|Percentage of Participants Having Remission of Type 2 Diabetes|The number of patients who 1 year after surgery, have a normal glycated hemoglobin (HbA1c) less than 6.5% and all medication is stopped|One year|||Percentage of Participants|||Number
780509|NCT00803959|Secondary|Patient Satisfaction With Treatment Outcome|A summary score for patient satisfaction was based on responses to questions developed for this study with scores ranging from 0 to 100 and higher scores indicating better satisfaction.|12 Months|There were 315 women randomized to each arm. In the UDS arm, 43 did not have primary outcome data leaving 272 in the intention-to-treat group. In the no UDS arm, 49 did not have primary outcome data leaving 266 in the ITT group. ITT analysis was used for all outcomes with the exception of the primary non-inferiority endpoint.||units on a scale||Standard Deviation|Mean
780510|NCT00803959|Secondary|Moderate or Severe Severity as Measured by the PGI-S|"The Patient Global Impression of Severity (PGI-S) has scores ranging from 1 [normal] to 4 [severe]. This measure is the percentage of participants responding to the PGI-S with a 3 corresponding to the moderate category or a 4 corresponding to the severe category at the 12 month visit."|12 Months|There were 315 women randomized to each arm. In the UDS arm, 43 did not have primary outcome data leaving 272 in the intention-to-treat group. In the no UDS arm, 49 did not have primary outcome data leaving 266 in the ITT group. One woman was missing PGI-S data in the UDS arm and was excluded leaving n=271 in the UDS arm.||percentage of participants|||Number
780511|NCT00803959|Secondary|Change in Severity as Measured by the PGI-S|The Patient Global Impression of Severity has scores ranging from 1 [normal] to 4 [severe]. Change was calculated as the score at 12 months minus the score at baseline and could range from -3 to 3. Higher scores indicate worse function, so the larger the negative value, the greater the improvement.|Baseline & 12 Months|There were 315 women randomized to each arm. In the UDS arm, 43 did not have primary outcome data leaving 272 in the intention-to-treat group. In the no UDS arm, 49 did not have primary outcome data leaving 266 in the ITT group. ITT analysis was used for all outcomes with the exception of the primary non-inferiority endpoint.||units on a scale||Standard Deviation|Mean
780512|NCT00803959|Secondary|Change in Quality of Life as Measured by the SF-12|The Medical Outcomes Study 12-Item Short Form Health Survey has scores ranging from 0 to 200 and higher scores indicating better health. Change was calculated as the score at 12 months minus the score at baseline and could range from -200 to 200. The larger the positive value, the greater the improvement.|Baseline, 12 Months|There were 315 women randomized to each arm. In the UDS arm, 43 did not have primary outcome data leaving 272 in the intention-to-treat group. In the no UDS arm, 49 did not have primary outcome data leaving 266 in the ITT group. ITT analysis was used for all outcomes with the exception of the primary non-inferiority endpoint.||units on a scale||Standard Deviation|Mean
780513|NCT00803959|Secondary|Change in Quality of Life as Measured by the IIQ|Incontinence Impact Questionnaire has scores ranging from 0 to 400 and higher scores indicating a more negative effect on quality of life. Change was calculated as the score at 12 months minus the score at baseline and scores could range from -400 to 400. Higher scores indicate worse function, so the larger the negative value, the greater the improvement.|Baseline, 12 Months|There were 315 women randomized to each arm. In the UDS arm, 43 did not have primary outcome data leaving 272 in the intention-to-treat group. In the no UDS arm, 49 did not have primary outcome data leaving 266 in the ITT group. ITT analysis was used for all outcomes with the exception of the primary non-inferiority endpoint.||units on a scale||Standard Deviation|Mean
780514|NCT00803959|Secondary|Change in MESA Urge Score|The Medical, Epidemiological, and Social Aspects of Aging (MESA) urge score was measured at baseline and the 12 month visit with a possible range from 0 to 100 with higher scores indicating worse function. The outcome measures is change from baseline to 12 mo visit in MESA urge score. Change was calculated as the score at 12 months minus the score at baseline and could range from -100 to 100. Higher raw scores indicate worse function, so the larger the negative change score value, the greater the improvement.|Screen & 12 Months|There were 315 women randomized to each arm. In the UDS arm, 43 did not have primary outcome data leaving 272 in the intention-to-treat group. In the no UDS arm, 49 did not have primary outcome data leaving 266 in the ITT group. ITT analysis was used for all outcomes with the exception of the primary non-inferiority endpoint.||units on a scale||Standard Deviation|Mean
780515|NCT00803959|Secondary|Change in MESA Stress Score|The Medical, Epidemiological, and Social Aspects of Aging (MESA) stress score was measured at baseline and the 12 month visit with a possible range from 0 to 100 with higher scores indicating worse function. The outcome measures is change from baseline to 12 mo visit in MESA stress score. Change was calculated as the score at 12 months minus the score at baseline and could range from -100 to 100. Higher raw scores indicate worse function, so the larger the negative change score value, the greater the improvement.|Screen & 12 Months|There were 315 women randomized to each arm. In the UDS arm, 43 did not have primary outcome data leaving 272 in the intention-to-treat group. In the no UDS arm, 49 did not have primary outcome data leaving 266 in the ITT group. ITT analysis was used for all outcomes with the exception of the primary non-inferiority endpoint.||units on a scale||Standard Deviation|Mean
780516|NCT00803959|Secondary|Change in Severity as Measured by the ISI|Incontinence Severity Index has scores ranging from 1 to 12 and higher scores indicating greater severity. Change was calculated as the score at 12 months minus the score at baseline. Higher scores indicate worse function, so the larger the negative value, the greater the improvement.|Baseline & 12 Months|There were 315 women randomized to each arm. In the UDS arm, 43 did not have primary outcome data leaving 272 in the intention-to-treat group. In the no UDS arm, 49 did not have primary outcome data leaving 266 in the ITT group. ITT analysis was used for all outcomes with the exception of the primary non-inferiority endpoint.||units on a scale||Standard Deviation|Mean
780517|NCT00803959|Secondary|Change in Bother as Measured by the UDI|The Urogenital Distress Inventory is a 20-item patient-reported measure that assesses the presence of urinary incontinence, urgency, frequency, and voiding dysfunction and the extent to which the patient is bothered by these symptoms. Scores range from 0 to 300, with higher scores indicating greater distress. Change was calculated as the score at 12 months minus the score at baseline. Higher scores indicate worse function, so the larger the negative value, the greater the improvement.|Baseline, 12 Months|There were 315 women randomized to each arm. In the UDS arm, 43 did not have primary outcome data leaving 272 in the intention-to-treat group. In the no UDS arm, 49 did not have primary outcome data leaving 266 in the ITT group. ITT analysis was used for all outcomes with the exception of the primary non-inferiority endpoint.||units on a scale||Standard Deviation|Mean
780533|NCT00789074|Secondary|Change in Pre-quit Ratings of Cigarette Satisfaction|"Satisfaction measured on a scale of 1-5; Have you found your cigarettes more or less enjoyable than usual in the last week? 1= much more and 5 = much less"|Baseline - week 4|Participants who provided ratings of cigarette satisfaction at each visit||units on a scale||Standard Deviation|Mean
780518|NCT00803959|Secondary|Patient Global Impression Index|"Patient Global Impression of Improvement is a patient-reported measure of perceived improvement that is obtained by asking study participants,
How is your urinary tract condition now, as compared with how it was before you received treatment for your urinary leakage?” Responses are on a 7-point scale from 1 meaning “very much better” to 7 meaning
very much worse.” Values of very much better (1) or much better (2) were considered to have perceived improvement according to this criteria. Values of 3 or greater were not (e.g. a little better, no change, a little worse, much worse or very much worse). This instrument correlates with the frequency of incontinence episodes, pad tests, and quality of life as it relates to incontinence."|12 Months|315 women were randomized to each arm. In the UDS arm, 43 did not have primary outcome data leaving 272 in the intention-to-treat group. In the no UDS arm, 49 did not have primary outcome data leaving 266 in the ITT group. Two were missing PGI-I data in the UDS arm and 4 in the no UDS arm; sample size was 262 in no UDS arm and 270 in the UDS arm.||percentage of participants|||Number
780519|NCT00803959|Secondary|Percentage Meeting or Exceeding 70% Decrease in UDI Score Between Baseline and 12 Months|The Urogenital Distress Inventory is a 20-item patient-reported measure that assesses the presence of urinary incontinence, urgency, frequency, and voiding dysfunction and the extent to which the patient is bothered by these symptoms. Scores range from 0 to 300, with higher scores indicating greater distress. The 70% cutoff value was selected on the basis of the previous experience of the study investigators and receiver-operating- characteristic curve analyses from a previous surgical trial.|Baseline, 12 mos|There were 315 women randomized to each arm. In the UDS arm, 43 did not have primary outcome data leaving 272 in the intention-to-treat group. In the no UDS arm, 49 did not have primary outcome data leaving 266 in the ITT group. ITT analysis was used for all outcomes with the exception of the primary non-inferiority endpoint.||percentage of participants|||Number
780520|NCT00803959|Primary|"Self-reported Urinary Incontinence, Irritative and Obstructive Symptoms: Reduction of 70%+ in the Urogenital Distress Inventory From Baseline to 12 Mos and Very Much or Much Better on the Patient Global Impression of Improvement Measure at 12 Mos."|"Treatment success is defined as a reduction in the Urogenital Distress Inventory score from baseline to 12 months of 70% or more and a Patient Global Impression of Improvement response of
“very much better” or “much better” at 12 months."|12 Months|There were 315 women randomized to each of the arms. In the no UDS arm (and UDS arm), 49 (43) did not have primary outcome data, leaving 266 (272) included in the ITT analysis. Of these, 259 (264) were included in the PP analysis with primary outcome data. The PP analysis was the primary analysis because the outcome was a non-inferiority endpoint.||percentage of participants|||Number
780521|NCT00789035|Secondary|Trough Concentrations of Empagliflozin in Plasma|Pre-dose (within 30 minutes before dosing) trough concentrations of Empagliflozin in plasma|Days 28, 56 and 84|All patients who received at least one dose of Empagliflozin and have some Pharmacokinetic (PK) data.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
780522|NCT00789035|Secondary|Change of Body Weight After 12 Weeks of Treatment|Results for change of body weight after 12 weeks of treatment based on ANCOVA.|Baseline and 12 weeks|FAS (CLOCF)||kg||Standard Error|Mean
780523|NCT00789035|Secondary|Change in Homeostasis Model Assessment Index for Beta Cell Function (HOMA-%B)|HOMA-%B (to assess insulin beta cell function) is defined as (20 x FPI)/(FPG-3.5). Results are based on ANCOVA.|Baseline and 12 weeks|FAS (CLOCF)||mU / mmol||Standard Error|Mean
780524|NCT00789035|Secondary|Change in Homeostasis Model Assessment Index for Insulin Resistance (HOMA-IR)|HOMA-IR (to assess insulin resistance) is defined as (FPI x FPG)/22.5. Results based on ANCOVA.|Baseline and 12 weeks|FAS (CLOCF)||mU/L x mmol/L||Standard Error|Mean
780525|NCT00789035|Secondary|Change From Baseline to Week 12 in Fasting Plasma Insulin (FPI)|Results for change of FPI from baseline at week 12 based on ANCOVA.|Baseline and 12 weeks|FAS (CLOCF)||mU/L||Standard Error|Mean
780526|NCT00789035|Secondary|Proportion of Patients Who Achieve an HbA1c Lowering of at Least 0.5% After 12 Weeks of Treatment|Results for HbA1c categories at week 12 (Proportion of patients with HbA1c lowered at least 0.5%).|12 weeks|FAS (CLOCF)||percentage of participants|||Number
780527|NCT00789035|Secondary|Proportion of Patients Who Achieve an HbA1c ≤7.0% After 12 Weeks of Treatment|Results for HbA1c categories at week 12 (Proportion of patients with HbA1c less than equal to 7%).|12 weeks|FAS (CLOCF)||percentage of participants|||Number
780528|NCT00789035|Secondary|Change of HbA1c From Baseline Over Time|Change of HbA1c from baseline over time. Results presented stem from a repeated measures analysis.|Baseline and weeks 4, 8 and 12|FAS, classical last observation carried forward (CLOCF) was used as the imputation method.||percentage of HbA1c||Standard Error|Mean
780529|NCT00789035|Secondary|Change of FPG From Baseline After 12 Weeks of Treatment|"Change of Fasting Plasma Glucose (FPG) from baseline after 12 weeks of treatment. Results presented stem from a repeated measures analysis.
Note, adjusted means are presented. For the placebo and empa groups, measured values presented are for the model including only these treatment groups, for the metformin group the measured values presented are for the model including only placebo and metformin groups."|Baseline and 12 weeks|FAS (LOCF)||mg/dL||Standard Error|Mean
780530|NCT00789035|Primary|Change of Glycosilated Haemoglobin A1c (HbA1c) From Baseline After 12 Weeks of Treatment|"Change of HbA1c from baseline after 12 weeks of treatment.
Note, adjusted means are presented. For the placebo and empa groups, measured values presented are for the model including only these treatment groups, for the metformin group the measured values presented are for the model including only placebo and metformin groups."|Baseline and 12 weeks|The full analysis set (FAS) consists of all randomised patients who were treated with at least 1 dose of study drug and had a baseline measurement of the primary endpoint. Modified last observation carried forward was used as the imputation method (LOCF).||percentage of HbA1c||Standard Error|Mean
780531|NCT00789074|Secondary|Change in MPSS Scores of Urges to Smoke and Cigarette Withdrawal Symptoms Throughout the First Four Weeks of Abstinence|"Change in the Mood and Physical Symptoms Scale (MPSS)*, scores of urges to smoke and cigarette withdrawal symptoms throughout the first four weeks of abstinence (measured weekly from weeks 4-8).
* The MPSS measures cigarette withdrawal symptoms. The scale is 1-5, 1 being not at all and 5 being extremely (depressed, irritable, restless, hungry, poor concentration, slept worse than usual)."|Week 4 - 8|Participants who were abstinent at 1 week and provided data on withdrawal symptoms||Scores on a scale||Standard Deviation|Mean
780532|NCT00789074|Secondary|Change in Pre-quit Cigarette Consumption|Participants reported average number of cigarettes smoked per day every week throughout the four week pre-quit period.|Baseline - week 4|All participants that provided data at each session||Cigarettes consumed per day||Standard Deviation|Mean
780536|NCT00789074|Primary|Rating of Urges to Smoke 24 Hours and One Week After the Target Quit Date Assessed by Mood and Physical Symptoms Scale|The scale measures tobacco withdrawal symptoms (depressed, irritable, restless, hungry, poor concentration, slept worse than usual) on 5-point scales from Not at all (rated as 1) to Extremely (rated as 5). It also asks 'How much of the time have you felt the urge to smoke in the last week? and 'How strong have these urges been?'; both rated on 6-point scales with higher numbers=higher craving.|24 hours and 7 days after quit date (week 4)|Were abstinent and provided data at 24 hours post quit date||units on a scale||Standard Deviation|Mean
780537|NCT00789113|Primary|Area Under the Curve (AUC) for Oral Bioavailability of Lamotrigine (LTG|To evaluate the absolute bioavailability of immediate release (IR) and extended release (ER) lamotrigine (LTG) via blood and urine sampling for 24 hour period followed by once a day blood sampling for 3 days following initial dose administration.|1 week|||µg*h/mL||95% Confidence Interval|Geometric Mean
780538|NCT00789191|Secondary|Self-measured 9-point Plasma Glucose Profile||Week 26|FAS (Full Analysis Set) is all randomised subjects exposed to at least one dose of trial product with a post baseline observation.||mmol/L||Standard Error|Mean
780539|NCT00789191|Secondary|Hypoglycemic Episodes: Night Time|Night time: Episodes between 11 am and 6 pm. Overall: All episodes. Minor: Symptomatic, with PG < 3.1 mmol/L. Symptoms only: Symptomatic with PG ≥ 3.1 mmol/L|Weeks 0-26|SAS (safety analysis set) is all randomised subjects exposed to at least one dose of trial product.||episodes|||Number
780540|NCT00789191|Secondary|Hypoglycemic Episodes: Day Time|Day time: Episodes between 6 pm and 11 am. Overall: All episodes. Minor: Symptomatic, with PG < 3.1 mmol/L. Symptoms only: Symptomatic with PG ≥ 3.1 mmol/L|Weeks 0-26|SAS (safety analysis set) is all randomised subjects exposed to at least one dose of trial product.||episodes|||Number
780541|NCT00789191|Secondary|Hypoglycemic Episodes|Overall: All episodes. Minor: Symptomatic, with PG < 3.1 mmol/L. Symptoms only: Symptomatic with PG ≥ 3.1 mmol/L|Weeks 0-26|SAS (safety analysis set) is all randomised subjects exposed to at least one dose of trial product.||episodes|||Number
780542|NCT00789191|Secondary|FPG (Fasting Plasma Glucose)||Week 26|FAS (Full Analysis Set) is all randomised subjects exposed to at least one dose of trial product with a post baseline observation.||mmol/L||Standard Error|Mean
780543|NCT00789191|Secondary|Change in Body Weight||Week 0, Week 26|FAS (Full Analysis Set) is all randomised subjects exposed to at least one dose of trial product with a post baseline observation.||kg||Standard Error|Mean
780544|NCT00789191|Secondary|Change in BMI (Body Mass Index)||Week 0, Week 26|FAS (Full Analysis Set) is all randomised subjects exposed to at least one dose of trial product with a post baseline observation.||kg/m^2||Standard Error|Mean
780545|NCT00789191|Secondary|Number of Subjects Achieving HbA1c Less Than or Equal to 6.5% Without Symptomatic Hypoglycaemia|Symptomatic hypoglycaemia is biochemically confirmed hypoglycaemia or major hypoglycaemia|Week 26|FAS (Full Analysis Set) is all randomised subjects exposed to at least one dose of trial product with a post baseline observation.||Subjects|||Number
780546|NCT00789191|Secondary|Number of Subjects Achieving HbA1c Less Than or Equal to 6.5%||Week 26|FAS (Full Analysis Set) is all randomised subjects exposed to at least one dose of trial product with a post baseline observation.||Subjects|||Number
780547|NCT00789191|Secondary|Number of Subjects Achieving HbA1c Less Than or Equal to 7.0% Without Symptomatic Hypoglycaemia|Symptomatic hypoglycaemia is biochemically confirmed hypoglycaemia or major hypoglycaemia|Week 26|FAS (Full Analysis Set) is all randomised subjects exposed to at least one dose of trial product with a post baseline observation.||Subjects|||Number
780548|NCT00789191|Secondary|Number of Subjects Achieving HbA1c Less Than or Equal to 7.0%||Week 26|FAS (Full Analysis Set) is all randomised subjects exposed to at least one dose of trial product with a post baseline observation.||Subjects|||Number
780549|NCT00789191|Primary|HbA1c (Glycosylated Haemoglobin A1c)||Week 26|Sample size calculation: Assuming a standard deviation of 1.0 for HbA1c, 100 subjects in each treatment arm would be required to obtain a power of 80% for detecting a HbA1c difference of 0.4%. FAS (Full Analysis Set) is all randomised subjects exposed to at least one dose of trial product with a post baseline observation.||Percent (%) glycosylated haemoglobin||Standard Error|Mean
780550|NCT00789256|Secondary|Determine Correlation Between in Vitro and in Vivo Activity of the Combination of Bortezomib and Melphalan.||7 Years||||||
780551|NCT00789256|Secondary|Determine Safety Profile of the Combination of Bortezomib and Melphalan.||7 Years||||||
780552|NCT00789256|Primary|Determine Response Rate of the Combination of Bortezomib and Melphalan in Patients With AML and High-risk MDS.||7 Years|||participants|||Number
780553|NCT00789321|Secondary|Change From Baseline in Foot Volume by Water Displacement (Weight of Water Displaced) at Week 2|Least Squares Mean Difference from Baseline|Baseline and 2 weeks|All patients treated with water displacement measurements at baseline and 2 weeks – one patient in the placebo group was not included (dropped out of study due to viral infection prior to Week 2) – two patients in the amlodipine group were excluded due to technical/procedural errors.||Grams||Standard Deviation|Least Squares Mean
780554|NCT00789321|Primary|Change From Baseline in Segmental Bioimpedance Measurements at 10 Kilohertz (KHz) at Week 2|Segmental biomimpedance was measured using a multifrequency analyzer (ImpediMed SFB7). The device was used to measure impedance (measured in Ohms) of a small current traveling between leads placed at the ankle and knee. Least Squares Mean Difference from Baseline in impedance is the primary endpoint.|Baseline and 2 weeks|All patients treated with segmental bioimpedance measurements at baseline and 2 weeks – one patient in the placebo group was not included (dropped out of study due to viral infection prior to Week 2).||Ohms||Standard Deviation|Least Squares Mean
780555|NCT00789373|Secondary|Percentage of Participants With Independently-Assessed Objective Tumor Response (Response Rate) During Maintenance Phase Up to Primary Data Cut-Off|Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response (CR)=disappearance of all target lesions; Partial Response (PR) is at least a 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD) is at least a 20% increase in sum of longest diameter of target lesions; Stable Disease (SD)=no change or small changes that do not meet the above criteria for CR, PR, or PD. Response Rate = (CR+PR)/Participants in Arm*100. Disease Control Rate=(CR+PR+SD)/Number of Participants in Arm*100.|Date of randomization to date of measured PD (up to 19.3 months)|All randomized participants||percentage of participants||95% Confidence Interval|Number
780556|NCT00789373|Secondary|Percentage of Participants With Objective Tumor Response (Response Rate) During Maintenance Phase of Study up to Primary Data Cut-Off|Analysis for combined phases was not performed since response was calculated separately for each phase of study. Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response (CR)=disappearance of all target lesions; Partial Response(PR)is at least a 30% decrease in sum of longest diameter of target lesions; Progressive Disease(PD) is at least a 20% increase in sum of longest diameter of target lesions; Stable Disease(SD)=no change or small changes that do not meet the above criteria for CR, PR, or PD.|Baseline to date of measured progressive disease (up to 19.3 months)|All randomized participants||percentage of participants|||Number
780557|NCT00789373|Secondary|Percentage of Participants With Serious Adverse Events During Maintenance Phase|A summary of serious adverse events is located in the Reported Adverse Event Module.|Baseline randomization through 30-day post-discontinuation visit (up to 49.7 months)|Randomized population with all serious adverse events included.||percentage of participants|||Number
780558|NCT00789373|Secondary|Percentage of Participants With a Non-Serious Adverse Event (AE) During Maintenance Phase|A summary of non-serious AEs is located in the Reported Adverse Event Module.|Baseline randomization through 30-day post-discontinuation visit (up to 49.7 months)|Randomized population with 2% cut-off threshold for inclusion for 19.3 months and 5% for 49.7 months.||percentage of participants|||Number
780559|NCT00789373|Secondary|Percentage of Participants With Hospitalizations Due to Adverse Events or Requiring Transfusion (Resource Utilization)||Baseline randomization through 30-day post-discontinuation visit (up to 19.3 months)|All randomized participants||percentage of participants|||Number
780560|NCT00789373|Secondary|Change From Baseline in EuroQol Instrument (EQ-5D) Visual Analog Scale (VAS)|Patients indicate their present health state through completion of the VAS. Possible scores range from 0 (worst imaginable health state) to 100 (best imaginable health state).|Baseline randomization through 30-day post-discontinuation visit (up to 19.3 months)|Participants who were randomized and completed the EQ-5D at baseline and at least once post-baseline.||units on a scale||Standard Deviation|Mean
780561|NCT00789373|Secondary|Change From Baseline in the EuroQol Instrument (EQ-5D) Index Score|The EQ-5D is a generic instrument that describes health status in 5 attributes (mobility, self-care, pain/discomfort, anxiety/depression, usual activities) using a three level scale (no problem, some problems, and major problems). These combinations of attributes are converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score range from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension).|Baseline randomization through 30-day post-discontinuation visit (up to 19.3 months)|Participants who were randomized and completed the EQ-5D at baseline and at least once post-baseline.||units on a scale||Standard Deviation|Mean
780562|NCT00789373|Secondary|Overall Survival (OS)|OS is the duration from enrollment to death. For patients who are alive, OS is censored at the last contact.|Date of randomization to the date of death from any cause up to 39.5 months|All randomized participants. In the Pemetrexed maintenance arm 103 (28.7%) participants were censored and in the Placebo maintenance arm 39 (21.7%) participants were censored.||months||95% Confidence Interval|Median
780563|NCT00789373|Secondary|Independently-assessed Objective Progression-free Survival (PFS)|To further evaluate the robustness of the PFS analysis, Lilly established an independent review of PFS to assess the potential for investigator bias in the determination of objective PD. PFS was measured from the date of randomization to the first date of objectively determined PD or death. For patients alive as of the data cutoff date and who did not have PD, PFS was censored at the date of the last objective tumor assessment. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD = 20% increase in sum of longest diameter of target lesions.|Date of randomization to first date of measured PD or date of death from any cause (up to 19.3 months)|Randomized participants with reviewable scan--(316/359 [88%] Maintenance arm and 156/180 [87%] Placebo comparator arm. The majority of unread scans (12.4%) were due to participants not completing 1 cycle of treatment by the data cutoff date (30 June 2010).||months||95% Confidence Interval|Median
780564|NCT00789373|Primary|Investigator-assessed Objective Progression-free Survival (PFS)|Investigator-assessed objective PFS was measured from the date of randomization to the first date of objectively determined progressive disease (PD) or death from any cause. For patients not known to have died as of the data cutoff date and who did not have objective PD, PFS was censored at the date of last objective tumor assessment. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD = 20% increase in sum of longest diameter of target lesions.|Date of randomization to the date of measured PD or date of death from any cause (up to 19.3 months)|All randomized participants||months||95% Confidence Interval|Median
780565|NCT00789438|Primary|Difference Between All Groups for the Surgical Pleth Index(SPI) at Defined Timepoints|Surgical Pleth Index (SPI), derived from finger photoplethysmographic signal has a range from 0 showing the lowest stress level to 100 showing the maximum stress level. SPI was compared between the groups during six defined time points: baseline (BL)- day before surgery; induction (IND)-before induction of general anesthesia or before spinal punction respectively; intubation (INT) or spinal punction (SPA); skin incision (INC), surgical suture (SU) and 10 minutes after admission to the recovery room (PACU). Difference between the groups is calculated using ANOVA.|Time points for outcome measures: Baseline, before Induction of anesthesia, during Intubation or Spinal Punction, during Skin Incision, during Surgical Suture, during Post Anesthesia Care Unit stay|||SPI and delta SPI (to baseline)||Standard Error|Median
780566|NCT00789477|Secondary|Number of Focal Laser Treatments||Week 1 to week 48|For the first 24 weeks, the Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) groups did not receive laser treatment. From week 24 onward, participants in the Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) groups were allowed to receive laser rescue treatment.||Treatments||Standard Deviation|Mean
780567|NCT00789477|Secondary|Change From Baseline in Central Retinal Thickness (CRT) as Assessed by Optical Coherence Tomography (OCT) - LOCF|Retinal thickness was evaluated using OCT at every visit except week 1. Missing values were imputed with post-baseline values during on-treatment period by using last observation carried forward (LOCF).|At week 24 and week 52|||microns||Standard Deviation|Mean
780568|NCT00789477|Secondary|Participants With Gains in ETDRS Letter Score of at Least 15 Letters - LOCF|Missing values were imputed with post-baseline values during on-treatment period by using last observation carried forward (LOCF).|At week 24 and week 52|FAS||participants|||Number
780569|NCT00789477|Secondary|Change in BCVA From Baseline to Week 52 - LOCF|Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at 4 meters. Missing values were imputed with post-baseline values during on-treatment period by using last observation carried forward (LOCF).|At week 52|FAS||letters correctly read||Standard Deviation|Mean
780570|NCT00789477|Primary|Change in BCVA From Baseline to Week 24 - Last Observation Carried Forward (LOCF)|"Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at 4 meters. Measurements were taken at every study visit.
Missing values were imputed with post-baseline values during on-treatment period by using last observation carried forward (LOCF)."|At week 24|The FAS was used for the primary efficacy analysis. It included patients as randomized.||letters correctly read||Standard Deviation|Mean
780571|NCT00789529|Secondary|Subject Questionnaire Response|"Subject questionnaire response: Overall comfort at 2 weeks in a 0-50 point scale.
0=Very poor 50 = Excellent"|2 weeks|||units on a scale||Standard Deviation|Mean
780572|NCT00789529|Primary|Objective, In-vivo Soft Contact Lens Wettability Index|The wettability index is derived from the slope of a metric developed to measure the regularity of the Shack–Hartmann wavefront sensor image. The more wettable a lens is the more stable the metric and the slope of the metric (the wettability index) is closer to zero. The more negative values indicate a less wettable the lens.|2 weeks|Per protocol. All participants that completed both arms were analysed.||wettability index||Standard Deviation|Mean
780573|NCT00789555|Primary|Self-Rated Relief Assessment at Day 30|"Relief assessment as rated by the subject on a 4-point scale, where 1=complete relief and 4=no relief. The subject answered the following question: I would rate the study medication's effectiveness for relieving my allergy symptoms since my last visit as: (1) Complete Relief; (2) Moderate Relief; (3) Mild Relief; (4) No Relief."|Day 30|Analysis population included all subjects enrolled under protocol Version 2.0 who received study drug and attended at least one on-therapy study visit (ITT), minus any missing data.||Units on a scale||Standard Deviation|Mean
780574|NCT00789555|Secondary|Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Physical Examination Parameters to Exit (Month 12 or Sooner)|Percentage of subjects with clinically relevant change from baseline in protocol-specific safety parameters to time of exit, based on the assessment of the investigator, regardless of causality (related or not related) to test article.|Baseline (Day 0), Exit (Month 12 or sooner)|Analysis population included all subjects who received study drug and attended at least one on-therapy study visit (ITT), minus any missing data.||Percentage of subjects|||Number
780575|NCT00789555|Secondary|Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Diastolic) to Exit (Month 12 or Sooner)|Percentage of subjects with change from baseline in diastolic blood pressure to time of exit, as obtained in a sitting position after the subject rested for five minutes. Two measurements, separated by two minutes, were obtained, from which the average systolic pressure was derived. If the first two readings differed by more than 5 millimeters of mercury (mmHg), a third reading was taken two minutes later and all three were used to determine the average. The disappearance of sound (phase 5) was used to define diastolic blood pressure.|Baseline (Day 0), Exit (Month 12 or sooner)|Analysis population included all subjects who received study drug and attended at least one on-therapy study visit (ITT), minus any missing data.||Percentage of subjects|||Number
780576|NCT00789555|Secondary|Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Systolic) to Exit (Month 12 or Sooner)|Percentage of subjects with change from baseline in systolic blood pressure to time of exit, as obtained in a sitting position after the subject rested for five minutes. Two measurements, separated by two minutes, were obtained, from which the average systolic pressure was derived. If the first two readings differed by more than 5 millimeters of mercury (mmHg), a third reading was taken two minutes later and all three were used to determine the average. The first appearance of sound (phase 1) was used to define systolic blood pressure.|Baseline (Day 0), Exit (Month 12 or sooner)|Analysis population included all subjects who received study drug and attended at least one on-therapy study visit (ITT), minus any missing data.||Percentage of subjects|||Number
780577|NCT00789555|Secondary|Percentage of Subjects With Change From Baseline (Day 0) in Pulse Rate Beats Per Minute (BPM) to Exit (Month 12 or Sooner)|Percentage of subjects with change from baseline in pulse measurement to time of exit, as recorded based on a full 60-second count after the patient rested for five minutes.|Baseline (Day 0), Exit (Month 12 or sooner)|Analysis population included all subjects who received study drug and attended at least one on-therapy study visit (ITT), minus any missing data.||Percentage of subjects|||Number
780578|NCT00789555|Primary|Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Nasal Examination Parameters to Exit (Month 12 or Sooner)|Percentage of subjects with clinically relevant change from baseline in protocol-specific safety parameters to time of exit, based on the assessment of the investigator, regardless of causality (related or not related) to test article.|Baseline (Day 0), Exit (Month 12 or sooner)|Analysis population included all subjects who received study drug and attended at least one on-therapy study visit (ITT), minus any missing data.||Percentage of subjects|||Number
780579|NCT00789581|Secondary|Overall Survival|The percentage of participants with overall survival at 3 and 5 years are presented. Overall survival (OS) defined as the time between randomization to date of death from any cause.|up to 5.25 years (63 months)|The intent-to-treat population (all randomized patients) are included in the analysis.||percentage of participants||95% Confidence Interval|Number
780580|NCT00789581|Primary|Disease-free Survival|The percentage of participants with disease-free survival at 3 and 5 years. Disease-free survival (DFS) is measured from the time between randomization and the date of first documented disease recurrence, or death from any cause.|up to 5.25 years (63 months)|The intent-to-treat population (all randomized patients) are included in the analysis.||percentage of participants||95% Confidence Interval|Number
780581|NCT00789672|Secondary|Mean Change in Amblyopic Eye Visual Acuity Letter Scores at 10 Weeks After Stopping Levodopa|Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.|baseline to 10 weeks after stopping levodopa|||letters||Standard Deviation|Mean
780582|NCT00789672|Secondary|Distribution of Change in Amblyopic Eye Visual Acuity Scores at 10 Weeks After Stopping Levodopa|Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.|baseline to 10 weeks after stopping levodopa|||participants|||Number
780583|NCT00789672|Secondary|Mean Change in Amblyopic Eye Visual Acuity Letter Scores at 4 Weeks Post Enrollment|Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.|enrollment to 4 weeks|||letters||Standard Deviation|Mean
780584|NCT00789672|Secondary|Distribution of Change in Amblyopic Eye Visual Acuity Scores at 4 Weeks Post Enrollment|Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.|enrollment to 4 weeks|||participants|||Number
780585|NCT00789672|Primary|Tolerability of Study Medication-Adverse Event Reporting|Number of adverse events reported throughout entire study.|24 weeks|||events|||Number
780586|NCT00789672|Primary|Mean Change in Amblyopic Eye Visual Acuity Letter Scores at 9 Weeks After Starting Levodopa|Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.|baseline to 9 weeks|||letters||Standard Deviation|Mean
780587|NCT00789672|Secondary|Mean Amblyopic Eye Visual Acuity Letter Scores at 10 Weeks After Stopping Levodopa|Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best.|10 weeks after stopping levodopa|||letters||Standard Deviation|Mean
780588|NCT00789672|Secondary|Distribution of Amblyopic Eye Visual Acuity Letter Scores at 10 Weeks After Stopping Levodopa|Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best. Letter scores are presented as Snellen Equivalents for presentation (i.e. 20/20 includes those with letter scores between 83 and 87 letters, 20/25 includes those with letter scores between 78 to 82 letters, etc.).|10 weeks after stopping levodopa|||participants|||Number
780589|NCT00789672|Secondary|Mean Amblyopic Eye Visual Acuity Letter Scores at 4 Weeks Post Enrollment|Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best.|4 weeks after enrollment|||letters||Standard Deviation|Mean
780590|NCT00789672|Secondary|Distribution of Amblyopic Eye Visual Acuity Letter Scores at 4 Weeks After Enrollment|Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best. Letter scores are presented as Snellen Equivalents for presentation (i.e. 20/20 includes those with letter scores between 83 and 87 letters, 20/25 includes those with letter scores between 78 to 82 letters, etc.).|4 weeks after enrollment|||participants|||Number
780591|NCT00789672|Primary|Distribution of Change in Amblyopic Eye Visual Acuity Scores at 9 Weeks After Starting Levodopa|Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.|baseline to 9 weeks|||participants|||Number
780592|NCT00789672|Primary|Mean Amblyopic Eye Visual Acuity Letter Scores at 9 Weeks After Starting Levodopa|Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.|9 weeks after starting levodopa|||letters||Standard Deviation|Mean
780593|NCT00789672|Primary|Distribution of Amblyopic Eye Visual Acuity Letter Scores at 9 Weeks After Starting Levodopa|Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. Letter scores are presented as Snellen Equivalents for presentation (i.e. 20/20 includes those with letter scores between 83 and 87 letters, 20/25 includes those with letter scores between 78 to 82 letters, etc.).|9 weeks after starting levodopa|||participants|||Number
780594|NCT00789685|Secondary|All Cause Mortality Rate at 6 Months|A long-term secondary efficacy variable was all cause mortality at 6 months following commencement of treatment|6 months following commencement of therapy|Number of patients whose survival status at 6 months was known||percentage of patients who died|||Number
780595|NCT00789685|Primary|All Cause Mortality at Day 28|The primary efficacy variable was all cause mortality at Day 28 following commencement of treatment|28 days following commencement of therapy|Patients included in Safety population||percentage of patients who died|||Number
780596|NCT00789685|Primary|Clinically Significant Treatment Emergent Events|Treatment-emergent adverse events (TEAEs) in safety population|From first dose up until Day 28|Patients included in Safety population||Number of patients|||Number
780597|NCT00789698|Secondary|Change From the Acute Phase Baseline to the End (Month 12) of the Double-blind Treatment in the Clinical Global Impression Severity Scale (CGI-S) Scores|The CGI-S is a clinician-rated assessment of the subject's current illness state on a scale ranging from 1-7, where a higher score is associated with greater illness severity.|Baseline and 12 months|The population is the intent to treat population which consists of those enrolled subjects who receive at least one dose of study medication and have either a PANSS or CGI-S baseline and post baseline measurements||units on a scale||95% Confidence Interval|Least Squares Mean
785192|NCT00835484|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 14 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
780598|NCT00789698|Secondary|Change From the Acute Phase Baseline to the End (Month 12) of the Double-blind Treatment in the Positive and Negative Syndrome Scale (PANSS)|The PANSS is an interview-based measure of psychopathology severity in adults with psychotic disorders. Thirty items are rated using a Likert scale, from 1 - 7. The PANSS total score is the sum of thirty items ranging from 30 to 210 (higher score representing a worsening in psychosis).|Baseline and 12 months|The population is the intent to treat population which consists of those enrolled subjects who receive at least one dose of study medication and have either a PANSS or CGI-S baseline and post baseline measurements||units on a scale||95% Confidence Interval|Least Squares Mean
780599|NCT00789698|Secondary|Change From the Acute Phase Baseline to Month 6 of the Double-blind Treatment in the CogState Computerized Cognitive Scores.|The battery has seven outcome measures that measure the cognitive constructs. The seven domains are: detection, identification, one back task, international shopping list task, one card learning task, Groton maze learning task and social emotional matching. The standardized scores for each subject at each assessment will then be averaged to yield a composite score. There are no maximum or minimum values, however a higher score indicates improved performance on the cognitive constructs. The change score is change from baseline to month 6.|Baseline and 6 Months|The population is the intent to treat population which consists of those enrolled subjects who receive at least one dose of study medication and have either a PANSS or CGI-S baseline and post baseline measurements||units on a scale||95% Confidence Interval|Least Squares Mean
780600|NCT00789698|Primary|Relapse of Psychotic Symptoms|"Time to relapse will be defined as the earliest occurrence of any of the following:
Worsening of >= 30% positive and negative syndrome scale total score from NCT00790192 and clinical global impression-severity sub-scale >=3
rehospitalization for worsening of psychosis
emergence of suicidal ideation, homicidal ideation and/or risk of harm to self or others Comparison of time to relapse of psychotic symptoms between lurasidone and quetiapine XR after 1 year as analyzed using the Cox proportional hazard model with country as a covariate."|12 Months|The population for relapse analyses is the relapse population which consists of those subjects who are enrolled in the present study, demonstrated response to 6 weeks of treatment with either lurasidone or quetiapine XR in study D1050233-NCT 00790192, and who took at least one dose of study medication in the present study.||participants|||Number
780601|NCT00789724|Secondary|Difference Between the 2 Arms in the Number of Adverse Effects Including a) All Events; b) All Events Requiring Unblinding of the Treatment; c) All Events Requiring Early Termination of the Intervention||10-14 weeks||||||
780602|NCT00789724|Secondary|Difference Between the 2 Arms in the Incidence of Significant Cardiac Arrhythmias in the Acute Phase||48 hours||||||
780603|NCT00789724|Secondary|Difference Between the 2 Arms in Change in Serum BNP Levels, C-reactive Protein, and Hemoglobin A1c% From Baseline to Follow up||10-14 weeks||||||
780604|NCT00789724|Secondary|Difference Between the 2 Arms in Change in the Number of Circulating Endothelial Progenitor Cells From Baseline to Follow up Exam||10-14 weeks||||||
780605|NCT00789724|Secondary|Difference Between the 2 Arms in Change in Oxygen Uptake Kinetics From Baseline to Follow up Exam at Submaximal Cardiopulmonary Exercise Test||10-14 weeks||||||
780606|NCT00789724|Secondary|Difference Between the 2 Arms in the Percentage of Patients With Any of the Following : a) End-systolic or End-diastolic Volume Index Increase >10%; b) Ejection Fraction Decrease >10%; c) E/E'>15 at Follow up||10-14 weeks||||||
780607|NCT00789724|Secondary|Difference Between the 2 Arms in Change in E/E' Ratios and Myocardial Performance (Tei) Indices From Baseline to Follow up Exam at Transthoracic Echo-color-Doppler Cardiac Exam||10-14 weeks||||||
780608|NCT00789724|Secondary|Difference Between the 2 Arms in Change in End-diastolic Volume Indices and Ejection Fraction Values From Baseline to Follow up Exam at Cardiac Magnetic Resonance Imaging||10-14 weeks||||||
780609|NCT00789724|Primary|Difference Between the Anakinra Arm and Placebo Arm in Change in End-systolic Volume Indices From Baseline to Follow up Exam 10-14 Weeks Later at Cardiac Magnetic Resonance Imaging.||10-14 weeks|||mL/m2||Inter-Quartile Range|Median
780610|NCT00789737|Secondary|Change in Postprandial Plasma Glucose, 2 Hours After a Meal Tolerance Test|To assess the change from baseline on postprandial plasma glucose, 2 hours after a meal tolerance test|from baseline to 24 weeks|Some participants may not have had lab results for this specific analysis and therefore excluded.||mg/dL||Standard Error|Least Squares Mean
780611|NCT00789737|Secondary|Changes in Apolipoprotein B (apoB)|To assess the effects of Welchol on changes in apolipoprotein B (apoB)|from baseline to 24 weeks|Some participants may not have had lab results for this specific analysis and therefore excluded.||mg/dL||Standard Error|Least Squares Mean
780612|NCT00789737|Secondary|Changes in Apolipoprotein A-I (apoA-I)|To assess the effects of Welchol on changes in apolipoprotein A-I (apoA-I)|from baseline to 24 weeks|Some participants may not have had lab results for this specific analysis and therefore excluded.||mg/dL||Standard Error|Least Squares Mean
780613|NCT00789737|Secondary|Changes in Triglycerides [TG]|To assess the effects of Welchol on changes in triglycerides [TG]|from baseline to 24 weeks|Some participants may not have had lab results for this specific analysis and therefore excluded.||mg/dL||Standard Error|Least Squares Mean
780614|NCT00789737|Secondary|Changes in Non-HDL-C|To assess the effects of Welchol on changes in non-HDL-C|from baseline to 24 weeks|Some participants may not have had lab results for this specific analysis and therefore excluded.||mg/dL||Standard Error|Least Squares Mean
780615|NCT00789737|Secondary|Changes in High Density Lipoprotein Cholesterol [HDL-C]|To assess the effects of Welchol on changes in high density lipoprotein cholesterol [HDL-C]|from baseline to 24 weeks|Some participants may not have had lab results for this specific analysis and therefore excluded.||md/dL||Standard Error|Least Squares Mean
780616|NCT00789737|Secondary|Changes in Low Density Lipoprotein Cholesterol [LDL-C]|To assess the effects of Welchol on changes in low density lipoprotein cholesterol [LDL-C]|from baseline to 24 weeks|Some participants may not have had lab results for this specific analysis and therefore excluded.||mg/dL||Standard Error|Least Squares Mean
780617|NCT00789737|Secondary|Changes in Total Cholesterol [TC]|To assess the effects of Welchol on changes in total cholesterol [TC]|from baseline to 24 weeks|Some participants may not have had lab results for this specific analysis and therefore excluded.||mg/dL||Standard Error|Least Squares Mean
780618|NCT00789737|Secondary|% Subjects With a Decrease in FPG >=30 mg/dL|% Subjects with a decrease in Fasting Plasma Glucose >=30 mg/dL from baseline to 24 weeks|from baseline to 24 weeks|Some participants may not have had lab results for this specific analysis and therefore excluded.||percentage of participants|||Number
780620|NCT00789737|Secondary|% Subjects With a Decrease in HbA1c of >= 0.7 Percentage Units|to determine the percentage of participants who experience a reduction in HbA1c of at least 0.7 percentage units at 24 weeks from baseline.|24 weeks|Some participants may not have had lab results for this specific analysis and therefore excluded.||percentage of participants|||Number
780621|NCT00789737|Secondary|Change in Fasting Plasma Glucose|to determine changes in Glycemic control after 24 weeks on therapy|from baseline to 24 weeks|Some participants may not have had lab results for this specific analysis and therefore excluded.||mg/dL||Standard Error|Least Squares Mean
780622|NCT00789737|Primary|Percent Change in Hemoglobin A1c|change in HbA1c from baseline to Week 24|24 week|Intent to Treat, Last Observation Carried Forward (LOCF) Some participants may not have had lab results for this specific analysis and therefore excluded.||percentage change of hemoglobin A1c||Standard Error|Mean
780623|NCT00789750|Secondary|Change From Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)|HOMA-IR is a calculation of fasting insulin and fasting glucose that shows the level of insulin resistance. Lower numbers are better.|Baseline, Week 24|Intent-to-treat set, with values at both baseline and Week 24 with last observation carried forward||calculation||Standard Error|Least Squares Mean
780624|NCT00789750|Secondary|Change From Baseline in Fasting C-peptide||Baseline, Week 24|Intent-to-treat set, with values at both baseline and Week 24 with last observation carried forward||ng/mL||Standard Error|Least Squares Mean
780625|NCT00789750|Secondary|Change From Baseline in Fasting Insulin Levels||Baseline, Week 24|Intent-to-treat set, with values at both baseline and Week 24 with last observation carried forward||µIU/mL||Standard Error|Least Squares Mean
780626|NCT00789750|Secondary|Percent Change From Baseline in Apolipoprotein B (Apo B)|Apo B is measured in mg/dL|Baseline, Week 24|Intent-to-treat set, with values at both baseline and Week 24 with last observation carried forward||percentage of change||Standard Error|Least Squares Mean
780627|NCT00789750|Secondary|Percent Change From Baseline in Apolipoprotein A-1 (Apo A-I)|Apo A-1 is measured in mg/dL|Baseline, Week 24|Intent-to-treat, with values at both baseline and Week 24 with last observation carried forward||percentage of change||Standard Error|Least Squares Mean
780628|NCT00789750|Secondary|Percent Change From Baseline in Triglycerides (TG)|TG are measured in mg/dL|Baseline, Week 24|Intent-to-treat set, with values at both baseline and Week 24 with last observation carried forward||percentage of change||Inter-Quartile Range|Median
780629|NCT00789750|Secondary|Percent Change From Baseline in Non-HDL-C|Non-HDL-C is measured in mg/dL|Baseline, Week 24|Intent-to-treat set, with values at both baseline and Week 24 with last observation carried forward||percentage of change||Standard Error|Least Squares Mean
780630|NCT00789750|Secondary|Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)|HDL-C is measured in mg/dL|Baseline, Week 24|Intent-to-treat set, with values at both baseline and Week 24 with last observation carried forward||percentage of change||Standard Error|Least Squares Mean
780631|NCT00789750|Secondary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)|LDL-C is measured in mg/dL|Baseline, Week 24|Intent-to-treat set, with values at both baseline and Week 24 with last count carried forward||percentage of change||Standard Error|Least Squares Mean
780632|NCT00789750|Secondary|Percent Change From Baseline in Total Cholesterol (TC)|TC is measured in milligrams per deciliter (mg/dL)|Baseline, Week 24|Intent-to-treat set, with values at both baseline and Week 24 with last observation carried forward||percentage of change||Standard Error|Least Squares Mean
780633|NCT00789750|Secondary|Number of Participants With a Reduction in FPG of >= 30 mg/dL||Week 24|Intent-to-treat set, with last count carried forward||Participants|||Count of Participants
780634|NCT00789750|Secondary|Number of Participants With a Decrease of >= 0.5 Percent in HbA1c||Week 24|Intent-to-treat set, with last count carried forward||Participants|||Count of Participants
780635|NCT00789750|Secondary|Number of Participants With a Decrease of >= 0.7 Percent in HbA1c||Week 24|Intent-to-treat set, with last count carried forward||Participants|||Count of Participants
780636|NCT00789750|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|In this study a reduction in FPG of at least 30 mg/dL is considered glycemic response.|Baseline, Week 24|Participants in the intent-to-treat set with values at both baseline and Week 24 with last observation carried forward||mg/dL||Standard Error|Least Squares Mean
780637|NCT00789750|Secondary|Number of Participants Achieving an HbA1c Goal of <7.0%||Week 24|Intent-to-treat set, with last observation carried forward||Participants|||Count of Participants
780638|NCT00789750|Secondary|Change From Baseline in HbA1c at Week 16||Baseline, Week 16|Intent to treat set, with baseline and post-baseline measures at the given time point||percent||Standard Error|Least Squares Mean
780639|NCT00789750|Secondary|Change From Baseline in HbA1c at Week 8||Baseline, Week 8|Intent to treat set, with baseline and post-baseline measures at the given time point||percent||Standard Error|Least Squares Mean
780640|NCT00789750|Secondary|Change From Baseline in HbA1c at Week 4||Baseline, Week 4|Intent to treat set, with baseline and post-baseline measures at the given time point||percent||Standard Error|Least Squares Mean
780641|NCT00789750|Primary|Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24||Baseline, Week 24|Intent-to-treat, last observation carried forward||percent||Standard Error|Least Squares Mean
780642|NCT00789802|Secondary|To Compare Continuation Rates of the LNG-IUC at the End of the 16 Week and 12 Month Periods Between the 3 Study Groups||12 months||||||
780643|NCT00789802|Secondary|To Compare the Level of Patient Satisfaction With the LNG-IUC at the End of the 16 Week and 12 Months Periods Between the 3 Study Groups.||16 week||||||
780644|NCT00789802|Secondary|To Describe and Compare the Bleeding Patterns Observed in Women With a LNG-IUC Treated With Naproxen, Estradiol and Placebo.||16 weeks||||||
780645|NCT00789802|Primary|Number of Bleeding and Spotting Days|The median number of bleeding and spotting days was 27.5 (range 5-83) in the naproxen group, 44 (2-82) in the estradiol group, and 32 (9-84) in the placebo group.|12 weeks|||DAYS||Full Range|Median
780646|NCT00789815|Secondary|Patients Willing Return if Repeated Bronchoscopy is Indicated.|"Patients were asked their willingness to return for another FB if needed by means of a five-point scale (definitely not, probably not, unsure, probably would, and definitely would return). Both probably would, and definitely would return were defined as patients agreed to return."|After patients recovered orientation and before they leaved the scope room.|Patients who answered the question in the questionnaire after bronchoscopy||participants|||Number
780648|NCT00789815|Primary|The Global Tolerance for Flexible Bronchoscopy by Verbal Analogus Scale|The global tolerance of the entire procedure was evaluated on a 10-point verbal analogous scale (VAS, 0: no bother, 10: worst intolerable).|After patients recovered orientation and before they leaved the scope room.|Patients received intervention completely||units on a scale||Full Range|Median
780649|NCT00789815|Secondary|The Recovery Time to Orientation|The time to orientation defined as the time between finishing flexible bronchoscopy to the moment when patients could open their eyes spontaneously, could recall their date of birth, and perform a finger-nose test correctly|After the bronchoscope leaving patients' nose or mouth to the time patients returned orientation|||minutes||Standard Deviation|Mean
780650|NCT00789815|Secondary|The Number of Participants Causing Any Procedure Interference by Cough|“Procedure interference by cough” was when the bronchoscopist had to stop the procedure temporarily and additional xylocaine spray and/or alfentanil had to be given to stop the cough.|From the time when bronchoscope introducing patients' nose or mouth to the time when bronchoscope leaving patients' nose or mouth|||participants|||Number
780651|NCT00789815|Secondary|The Number of Participants Causing Any Procedure Interference by the Patients' Movement During Flexible Bronchoscocopy|“Procedure interference by patients’ movement” was when the bronchoscopist had to stop the procedure temporarily and our assistant had to hold down the irritant patient|From the time when bronchoscope introducing patients' nose or mouth to the time when bronchoscope leaving patients' nose or mouth|||participants|||Number
780652|NCT00789815|Primary|The Number of Participants With Any Hypotension Event During Flexible Bronchoscopy|The event of hypotension: when the systolic blood pressure (SBP) was less than 90mmHg with any duration.|From the time when bronchoscope introducing patients' nose or mouth to the time when bronchoscope leaving patients' nose or mouth|patients completed the whole intervention||participants|||Number
780653|NCT00789815|Primary|The Number of Participants With Any Hypoxemia Event During Flexible Bronchoscopy|The hypoxemia event is defined as that when the oxyhemoglobin (SpO2) was less than 90% with any duration during the flexible bronchoscopy.|From the time when bronchoscope introducing patients' nose or mouth to the time when bronchoscope leaving patients' nose or mouth|Patients completed the whole intervention.||participants|||Number
780654|NCT00789828|Secondary|Percentage of Participants With Renal Impairment During Core Period|Renal function was assessed using glomerular filtration rate (GFR) based on age measure; Modification of Diet in Renal Disease (MDRD) formula for participants aged 18 years or older, defined as GFR equal to 32788*(serum creatinine (micromol/L)^-1.154)*(age^-0.203 )*(0.742, if female)*(1.210, if black), and Schwartz formula for participants less than 18 years defined as GFR equal to 0.41*height (cm)/ Serum creatinine (mg/dL). Participants with severe renal impairment defined as GFR < 30 mL/min/1.73 m^2 and participants with National Cancer Institute’s Common Terminology Criteria for Adverse Events (NCI-CTCAE) grade 3/4 serum creatinine were reported.|Day 1 up to 28 days after end of treatment (Core period)|"The analysis was performed in the SAF population. Here, Number of participants analysed signifies the participants assessed for renal function during the study for each arm, respectively."||Percentage of participants|||Number
780655|NCT00789828|Secondary|Everolimus Trough Concentrations (Cmin) at 24 Hours After Last Dose|The participants were assessed for everolimus trough concentration (Cmin) at 24 hours time point after previous dose administration, at a steady state following 5 days of consistent dosing, if the participant did not vomit within 4 hours of previous dose. Tandem liquid chromatography-mass spectrometry method was used for evaluation. Cmin values were categorized as <5 ng/mL, 5-10 ng/mL, and >10 ng/mL, concentrations below the lower limit of quantification were entered as 0 ng/mL.|24 hours post dose on Week 6, Week 24, Week 48, Week 72, Week 96, Week 144, and Week 240|The analysis was performed in the Safety Set population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||ng/mL||Standard Deviation|Mean
780656|NCT00789828|Secondary|Everolimus Blood Concentration (C2h) at 2 Hours Post Dose|The participants were assessed for everolimus blood concentration at 2 hours time point after dose administration on the same day, if the participant did not vomit between previous dose and blood sample collection. Tandem liquid chromatography-mass spectrometry method was used for evaluation. C2h values were categorized as < 20 ng/mL, 20-50 ng/mL, and > 50 ng/mL, concentrations below the lower limit of quantification were entered as 0 ng/mL.|2 hours post dose on Week 6, Week 24, Week 48, Week 96, Week 144, and Week 240|The analysis was performed in the Safety Set population (Only evaluable PK Samples), defined as participants who received at least one dose of the double-blind study drug, with a valid post baseline assessment. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||ng/mL||Standard Deviation|Mean
780657|NCT00789828|Secondary|Duration of Skin Lesion Response in Everolimus Treated Participants|Duration of skin lesion response was defined as the time from the first skin lesion response until the first skin lesion progression, defined as worsening of lesion by > 25% or more from baseline.|Baseline up to week 48 (end of core period), and end of extension period (up to 4 years)|The analysis was performed in the FAS population. Here, “Number of participants analysed” signifies everolimus treated responders with best overall skin lesion response during the core and extension period, respectively.||months||95% Confidence Interval|Median
780658|NCT00789828|Secondary|Percentage of Participants With Skin Lesions Assessed Using Physician's Global Assessement Overall Score|Skin lesions included hypomelanotic macules, the shagreen patch, periungual or subungual fibromas, facial angiofibromas and/or forehead plaques. Response was evaluated using the Physician’s Global Assessment of Clinical Condition (PGA) on a 7-point scale: Grade 0 = complete clinical response, indicated absence of disease, Grade 1, 2, and 3 = partial response, indicated improvements of ≥ 50% but < 100%, Grade 4, 5 = stable disease, indicated some or no improvements of 25% - < 50% and 6 = progressive disease, indicated worse than at baseline evaluation by > 25%. Response rate was determined for participants with ≥ 1 skin lesion at baseline, defined as the percentage of participants with overall status as complete clinical response or partial response.|End of core period (Week 48), and end of extension period (up to 4 years)|"The analysis was performed in the FAS population. Here, Number of participants analysed signifies the participants assessed for skin lesion response during the study for each arm, respectively."||Percentage of participants||95% Confidence Interval|Number
781057|NCT00808639|Secondary|Number of Patients Experiencing Surgery-related Toxicity|Surgery-related toxicity defined per CTCAEv3 as Grade 2 or higher and treatment attribution possibly, probably or definitely-related.|Surgery + 30 days|Number of patients who underwent cystectomy.||participants||90% Confidence Interval|Number
780659|NCT00789828|Secondary|Time to SEGA Worsening|Time to SEGA worsening was defined as the time from the start of everolimus to date of the first SEGA worsening. SEGA worsening was defined as either; increase from nadir of ≥ 25% in SEGA volume or unequivocal worsening of non-target SEGA lesions, or appearance of new SEGA lesion ≥ 1.0 cm in longest diameter, or new or worsening hydrocephalus. The median value was not reached in either treatment arm of core period as SEGA worsening was observed in less participants (everolimus - 7 and placebo - 8).|Baseline up to week 48 (end of core period), and end of extension period (up to 4 years)|"The analysis was performed in the FAS population. Here, Number of participants analysed signifies the participants assessed for time to SEGA worsening during the study for each arm, respectively."||months||95% Confidence Interval|Median
780660|NCT00789828|Secondary|Duration of SEGA Response|Duration of SEGA response was defined as time from the date of the first documented SEGA response until the date of the first documented SEGA progression. Duration of SEGA response was evaluated only for participants who achieved a SEGA response. The time to SEGA progression was censored if SEGA progression was not observed before the first to occur out of (i) analysis cut-off date (ii) the date when systemic anti-SEGA medication is started, (iii) the date of a SEGA-related surgery or (iv) the date of death. Since, no case of SEGA progression was observed in core study which resulted in censored duration of SEGA response. Only 5 SEGA responders experienced a SEGA progression in extension period.|Baseline up to week 48 (end of core period), and end of extension period (up to 4 years)|"The analysis was performed in the FAS population. Here, Number of participants analysed signifies the participants assessed for SEGA progression during the study for each arm, respectively."||months||95% Confidence Interval|Median
780661|NCT00789828|Secondary|Time to SEGA Response|Participants were assessed for time to SEGA response, defined as 50% reduction from baseline in SEGA volume (where SEGA volume was the sum of the volumes of all target SEGA lesions identified at baseline, and confirmed with a second scan performed approximately 12 weeks later), no unequivocal worsening of non-target SEGA lesions, no new SEGA lesions (≥ 1 cm in longest diameter), and no new or worsening hydrocephalus. Multi-phase brain MRI was utilised to identify SEGA lesions. SEGA response rate was defined as the percentage of participants whose best overall status was SEGA response as determined by Independent Central Radiology Review. The Kaplan-Meier estimate was used for determining time to SEGA response.|Baseline up to week 48 (end of core period), and end of extension period (up to 4 years)|The analysis was performed in the FAS population.||months||95% Confidence Interval|Median
780662|NCT00789828|Secondary|Time to SEGA Progression|Time to SEGA progression was defined as time between randomisation to time to first SEGA progression. SEGA progression was defined as either one or more of the following criteria: 1. increase from nadir of ≥ 25% in SEGA volume to a value greater than baseline SEGA volume (where SEGA volume is the sum of the volumes of all target SEGA lesions identified at baseline, and nadir is the lowest SEGA volume obtained for the participant previously in the trial), 2. unequivocal worsening of non-target SEGA lesions, 3. appearance of new SEGA lesion ≥ 1.0 cm in longest diameter, 4. new or worsening hydrocephalus. The median TTSP based on central radiology review was not reached in any treatment arms; Only 6 events of SEGA progressions were observed in the placebo group of core period.|Baseline up to week 48 (end of core period), and end of extension period (up to 4 years)|"The analysis was performed in the FAS population. Here Number of participants analysed signifies the participants assessed for time to SEGA progression during the study for each arm, respectively."||months||95% Confidence Interval|Median
780663|NCT00789828|Secondary|Change From Baseline in Frequency of Total Seizure Events Per 24 Hours at Week 24 in Both Core and Extension Period|Seizure frequency per 24 hours was defined as the number of seizures in the electroencephalography (EEG) divided by the number of hours in the EEG, multiplied by 24. Seizure frequency was evaluated using a 24-hour video-EEG. Seizure frequency was listed as missing if the actual EEG recording duration was < 18 hours.|Baseline (Core period) to Week 24 (Core period), Baseline (Extension period, Week 24 post-core baseline) to Week 24 (Extension period, Week 48 post-core baseline)|The analysis was performed in the FAS population. Missing values were imputed using last observation carried forward approach for core period while raw count for extension period.||Seizure frequency||Standard Deviation|Mean
780664|NCT00789828|Primary|Percentage of Participants With Best Overall Subependymal Giant Cell Astrocytomas (SEGA) Response|Participants were assessed for SEGA response, defined as 50% reduction from baseline in SEGA volume (where SEGA volume was the sum of the volumes of all target SEGA lesions identified at baseline, and confirmed with a second scan performed approximately 12 weeks later), no unequivocal worsening of non-target SEGA lesions, no new SEGA lesions (≥ 1 cm in longest diameter), and no new or worsening hydrocephalus. Multi-phase brain MRI was utilized to identify SEGA lesions. SEGA response rate was defined as the percentage of participants whose best overall status was SEGA response as determined by Independent Central Radiology Review. The Kaplan-Meier estimate was used for determining time to SEGA response.|End of core period (Week 48), and end of extension period (up to 4 years)|The primary analysis was performed in Full Analysis Set (FAS) population, defined as all randomized participants involved in the study.||Percentage of participants||95% Confidence Interval|Number
780665|NCT00789854|Secondary|Change in Clinical Global Impression (CGI) Item 4 Efficacy and Safety Combined, Patients With Two Previous Treatment Failures|The physician has evaluated the therapeutic effect and the side effect combined at end of study. Patients with a ‘marked/moderate’ therapeutic effect and ‘None/Do Not Significantly Interfere’ side effect has been added. The higher values show more patients with a treatment effect without any side-effect. The range is from 0 patients to the maximum number of patients in the treatment arm.|6 week of treatments|||Participants|||Number
780666|NCT00789854|Secondary|Change in Clinical Global Impression (CGI) Item 4 Efficacy and Safety Combined, Patients With One Previous Treatment Failure|The physician has evaluated the therapeutic effect and the side effect combined at end of study. Patients with a ‘marked/moderate’ therapeutic effect and ‘None/Do Not Significantly Interfere’ side effect has been added. The higher values show more patients with a treatment effect without any side-effect. The range is from 0 patients to the maximum number of patients in the treatment arm.|6 weeks of treatment|||Participants|||Number
780667|NCT00789854|Secondary|Change in Clinical Global Impression (CGI) Item 4 Efficacy and Safety Combined, All Patients|The physician has evaluated the therapeutic effect and the side effect combined at end of study. Patients with a ‘marked/moderate’ therapeutic effect and ‘None/Do Not Significantly Interfere’ side effect has been added. The higher values show more patients with a treatment effect without any side-effect. The range is from 0 patients to the maximum number of patients in the treatment arm (225, 229 or 221).|6 weeks of treatment|||Participants|||Number
780668|NCT00789854|Secondary|Change in Work Productivity and Activity Impairment: General Health (WPAI:GH)|Self rating assessment of working productivity using WPAI:GH (Scale 0 to number of hours worked during a week multiplied with the salary in Euro, a lower value shows a larger improvement)|6 weeks of treatment|||Scores on a scale||Standard Error|Least Squares Mean
780669|NCT00789854|Secondary|Change in Quality of Life Measured by Health Questionnaire EQ-5D as Utility|Self rating assessment of quality in life using EQ-5D utility (Scale 0-100, where a higher value shows a larger improvement)|6 weeks of treatment|||Scores on a scale||Standard Error|Least Squares Mean
780670|NCT00789854|Secondary|Change in Quality of Life Measured by Short-form Health Survey (SF-36), Physical Component|Self rating assessment of quality in life using SF-36, physical component (Scale 0-100, where a higher value shows a larger improvement)|6 weeks of treatment|||Scores on a scale||Standard Error|Least Squares Mean
780671|NCT00789854|Secondary|Change in Quality of Life Measured by Short-form Health Survey (SF-36), Mental Component|Self rating assessment of quality in life using SF-36, mental component (Scale 0-100, where a higher value shows a larger improvement)|6 weeks of treatment|||Scores on a scale||Standard Error|Least Squares Mean
780672|NCT00789854|Secondary|Change in Sleep Quality Measured by Pittsburgh Sleep Quality Index (PSQI)|Self-rated sleeping quality measured by PSQI (Scale 0-21, subscales 0-3, 18 questions, where a lower value shows a larger improvement)|6 weeks of treatment|||Scores on a scale||Standard Error|Least Squares Mean
780673|NCT00789854|Secondary|Change in Sleep Quality Measured by Montgomery Asberg Depression Rating Scale (MADRS), Item 4|Sleeping quality measured by Montgomery-Asberg Depression Rating Scale (MADRS) item 4 (reduced sleep) (Scale 0-6, where a lower value shows a larger improvement)|6 weeks of treatment|||MADRS item 4 score||Standard Error|Least Squares Mean
780674|NCT00789854|Secondary|Change in Anxiety Measured by STAI, Trait Anxiety Inventory|Self-rating assessment of anxiety measured by State-Trait Anxiety Inventory (STAI), trait anxiety inventory (Scale 20-80, where a lower value shows a larger improvement)|6 weeks of treatment|||Scores on a scale||Standard Error|Least Squares Mean
780675|NCT00789854|Secondary|Change in Anxiety Measured by State-Trait Anxiety Inventory (STAI), State Anxiety Inventory|Self-rating assessment of anxiety measured by STAI, state anxiety inventory (Scale 20-80, where a lower value shows a larger improvement)|6 weeks of treatment|||Scores on a scale||Standard Error|Least Squares Mean
780676|NCT00789854|Secondary|Change in Anxiety Measured by Visual Analog Scale (VAS)|Self-rating assessment of anxiety using a visual analogue scale (VAS). Scale from 0-100, where a lower value shows a larger improvement.|6 weeks of treatment|||scores on a scale||Standard Error|Least Squares Mean
780677|NCT00789854|Secondary|Change in Pain, Measured by Visual Analog Scale (VAS)|Self-rating assessment of pain using a visual analogue scale (VAS). Scale from 0-100, where a lower value shows a larger improvement.|6 weeks of treatment|||scores on a scale||Standard Error|Least Squares Mean
780678|NCT00789854|Secondary|Change in Beck Depression Inventory (BDI)|Self-rating assessment of depressive symptoms using Beck Depression Inventory (BDI). Scale from 0-63, where a lower value shows a larger improvement.|6 weeks of treatment|||scores on a scale||Standard Error|Least Squares Mean
780679|NCT00789854|Secondary|Change in Clinical Global Impression Scale (CGI-S), Patients With Two Previous Treatment Failure|Change in severity of illness measured by Clinical Global Impression Scale (CGI-S). Scale from 1-7, where a lower value shows a larger improvement.|6 weeks of treatment|||scores on a scale||Standard Error|Least Squares Mean
780680|NCT00789854|Secondary|Change in Clinical Global Impression Scale (CGI-S), Patients With One Previous Treatment Failure|Change in severity of illness measured by Clinical Global Impression Scale (CGI-S). Scale from 1-7, where a lower value shows a larger improvement.|6 weeks of treatment|||scores on a scale||Standard Error|Least Squares Mean
780681|NCT00789854|Secondary|Change in Clinical Global Impression Scale (CGI-S), All Patients|Change in severity of illness measured by Clinical Global Impression Scale (CGI-S). Scale form 1-7, where a lower value shows a larger improvement.|6 weeks of treatment|||scores on a scale||Standard Error|Least Squares Mean
780682|NCT00789854|Secondary|Responder: Clinical Global Impression Improvement (CGI-I) Item 2, Patients With Two Previous Treatment Failure|Change in global improvement measured by Clinical Global Impression Improvement (CGI-I). Scale from 1-4, where a lower value shows a larger improvement.|6 weeks of treatment|||scores on a scale||Standard Deviation|Mean
780683|NCT00789854|Secondary|Responder: Clinical Global Impression Improvement (CGI)-I Item 2, Patients With One Previous Treatment Failure|Change in global improvement measured by Clinical Global Impression Improvement (CGI-I). Scale from 1-4, where a lower value shows a larger improvement.|6 weeks of treatment|||scores on a scale||Standard Deviation|Mean
780684|NCT00789854|Secondary|Responder: Clinical Global Impression Improvement (CGI-I) Item 2, All Patients|Change in global improvement measured by Clinical Global Impression Improvement (CGI-I). Scale from 1-4, where lower value shows a larger improvement.|6 weeks of treatment|||scores on a scale||Standard Deviation|Mean
780685|NCT00789854|Secondary|Response Rate; Montgomery-Asberg Depression Rating Scale (MADRS) Score Reduced ≥ 50%, Patients With Two Previous Treatment Failure|Response rate at end of study measured as number of patients with Montgomery Asberg Depression Rating Scale (MADRS) with total score reduction ≥ 50% compared to baseline, the higher number of patients the better|6 weeks of treatment|||Participants|||Number
780686|NCT00789854|Secondary|Response Rate; Montgomery-Asberg Depression Rating Scale (MADRS) Score Reduced ≥ 50%, Patients With One Previous Treatment Failure|Response rate at end of study measured as number of patients with Montgomery Asberg Depression Rating Scale (MADRS) with total score reduction ≥ 50% compared to baseline, the higher number of patients the better|6 weeks of treatment|||Participants|||Number
780687|NCT00789854|Secondary|Response Rate; Montgomery-Asberg Depression Rating Scale (MADRS) Score Reduced ≥ 50%, All Patients|Response rate at end of study measured as number of patients with Montgomery Asberg Depression Rating Scale (MADRS) with total score reduction ≥ 50% compared to baseline, the higher number of patients the better|6 week of treatments|||Participants|||Number
780688|NCT00789854|Secondary|Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) ≤12|Number of patients in remission with total Montgomery Asberg Depression Rating Scale (MADRS) score ≤12. MADRS scale has range from 0 to 60, where the lower score indicates the better health status.|6 weeks of treatment|||Participants|||Number
780690|NCT00789854|Secondary|Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) ≤10, Patients With Two Previous Treatment Failure|Number of patients in remission with two previous treatment failure and with total Montgomery Asberg Depression Rating Scale (MADRS) score ≤10. MADRS scale has range from 0 to 60, where the lower score indicates the better health status.|6 weeks of treatment|||Participants|||Number
780691|NCT00789854|Secondary|Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) ≤10, Patients With One Previous Treatment Failure|Number of patients in remission with one previous treatment failure and with total Montgomery Asberg Depression Rating Scale (MADRS) score ≤10. MADRS scale has range from 0 to 60, where the lower score indicates the better health status.|6 weeks of treatment|||Participants|||Number
780692|NCT00789854|Secondary|Depression Remission; Montgomery-Asberg Depression Rating Scale MADRS ≤10, All Patients|Number of patients in remission, with total Montgomery Asberg Depression Rating Scale (MADRS) score ≤10. MADRS scale has range from 0 to 60, where the lower score indicates the better health status.|6 weeks of treatment|||Participants|||Number
780693|NCT00789854|Primary|Change in Depressive Symptoms Between Randomisation and Week 6 Measured by Change in Montgomery Asberg Depression Rating Scale (MADRS) Total Score (Modified Intention to Treat Analysis Set)|Change in LS mean total Montgomery Asberg Depression Rating Scale (MADRS) score from randomisation to end-of-treatment (week 6) (Scale 0-60), lower score indicates a better health status.|6 weeks of treatment|||scores on a scale||Standard Error|Least Squares Mean
780694|NCT00789854|Primary|Change in Depressive Symptoms Between Randomisation and Week 6 Measured by Change in Montgomery Asberg Depression Rating Scale (MADRS) Total Score (Per Protocol Analysis Set)|Change in LS mean total Montgomery Asberg Depression Rating Scale (MADRS) score from randomisation to end-of-treatment (week 6) (Scale 0-60), lower score indicates a better health status.|6 weeks treatment|Analysis was 'per protocol'. Exclusion reason from analysis: Violation of exclusion/inclusion criteria; Non-compliance regarding prohibited concomitant medication, Total unavailability of MADRS score after randomization, Patient not treated with any dose of study drug after randomization, Non-compliance regarding titration to 300 mg quetiapine/d.||scores on a scale||Standard Error|Least Squares Mean
780695|NCT00789880|Secondary|Change From Baseline on Day 21 in Relative Abundance of IL-13 mRNA in Lesional and Non-Lesional Skin for Psoriatic Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo|Cytokine interleukin-13 ( IL-13) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. There is no known clinical correlation between IL-13 and psoriasis.|Baseline to Day 21|||Cycle Number||Standard Deviation|Mean
780696|NCT00789880|Secondary|Change From Baseline on Day 21 in Relative Abundance of IL-13 mRNA in Non-Lesional Skin for Non-Atopic Dermatitis (Non-AD) Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo|Cytokine interleukin-13 ( IL-13) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. Non-AD is defined as a healthy volunteer without atopic dermatitis. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. A decrease in IL-13 may be clinically correlated with improvement of AD.|Baseline to Day 21|||Cycle Number||Standard Deviation|Mean
780697|NCT00789880|Secondary|Change From Baseline on Day 21 in Relative Abundance of IL-13 mRNA in Lesional and Non-Lesional Skin for Atopic Dermatitis (AD) Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo|Cytokine interleukin-13 (IL-13) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. A decrease in IL-13 may be clinically correlated with improvement of AD.|Baseline to Day 21|||Cycle Number||Standard Deviation|Mean
780698|NCT00789880|Primary|Change From Baseline on Day 21 in Relative Abundance of HBD-3 mRNA in Lesional and Non-Lesional Skin for Psoriatic Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo|Human Beta-defensin 3 (HBD-3) Messenger Ribonucleic acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. There is no known clinical correlation between HBD-3 and psoriasis.|Baseline to Day 21|||Cycle Number||Standard Deviation|Mean
780699|NCT00789880|Primary|Change From Baseline on Day 21 in Relative Abundance of HBD-3 mRNA in Non-Lesional Skin for Non-Atopic Dermatitis (Non-AD) Participants Who Received Oral Vitamin D3 Versus Vitamin D3-Placebo|Human Beta-defensin 3 (HBD-3) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. Non-AD is defined as a healthy volunteer without atopic dermatitis, therefore the lesional skin-type was not measured in this group. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. HBD-3 amount is clinically significant as it is necessary to resist infection. HBD-3 amount is not known to be clinically relevant to the clinical signs of dermatitis associated with AD.|Baseline to Day 21|||Cycle Number||Standard Deviation|Mean
781058|NCT00808639|Secondary|Number of Patients Experiencing Febrile Neutropenia|Febrile neutropenia defined per CTCAEv3 as Grade 3 or higher and treatment attribution possibly, probably or definitely-related.|After completion of 4 cycles of chemotherapy with pegfilgrastim support (cycle length 2 weeks)|||participants||90% Confidence Interval|Number
780700|NCT00789880|Primary|Change From Baseline on Day 21 in Relative Abundance of HBD-3 mRNA in Lesional and Non-Lesional Skin for Atopic Dermatitis (AD) Participants Who Received Oral Vitamin D3 Versus Vitamin D3-Placebo|Human Beta-defensin 3 (HBD-3) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies as measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. HBD-3 amount is clinically significant as it is necessary to resist infection. HBD-3 amount is not known to be clinically relevant to the clinical signs of dermatitis associated with AD.|Baseline to Day 21|||Cycle Number||Standard Deviation|Mean
780701|NCT00789880|Primary|Change From Baseline on Day 21 in Relative Abundance of CAMP mRNA in Lesional and Non-Lesional Skin for Psoriatic Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo|Cathelicidin (CAMP) messenger ribonucleic acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline, Cathelicidin abundance in psoriasis has been hypothesized to correlate with increased inflammation. No direct clinical correlation is known.|Baseline to Day 21|||Cycle Number||Standard Deviation|Mean
780702|NCT00789880|Primary|Change From Baseline on Day 21 in Relative Abundance of CAMP mRNA in Non-Lesional Skin for Non-Atopic Dermatitis (Non-AD) Participants Who Received Oral Vitamin D3 Versus Vitamin D3-Placebo|Cathelicidin (CAMP) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. Non-AD is defined as a healthy volunteer without atopic dermatitis, therefore the lesional skin-type was not measured in this group. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. Cathelicidin amount is clinically significant as it is necessary to resist infection. Cathelicidin amount is not known to be clinically relevant to the clinical signs of dermatitis associated with AD.|Baseline to Day 21|||Cycle Number||Standard Deviation|Mean
780703|NCT00789880|Primary|Change From Baseline on Day 21 in Relative Abundance of CAMP mRNA in Lesional and Non-Lesional Skin for Atopic Dermatitis (AD) Participants Who Received Oral Vitamin D3 Versus Vitamin D3-Placebo|Cathelicidin (CAMP) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. Cathelicidin amount is clinically significant as it is necessary to resist infection. Cathelicidin amount is not known to be clinically relevant to the clinical signs of dermatitis associated with AD.|Baseline to Day 21|||Cycle Number||Standard Deviation|Mean
780704|NCT00789958|Secondary|2-year Overall Local Relapse Rate|Local relapse is any evidence of new disease within the primary tumor bed or the regional (retroperitoneal, celiac, and portal vein nodes) lymphatics (these areas are to be encompassed within the radiation fields).|Up to 2 years from registration|Eligible and analyzable patients that received protocol treatment.||percentage of participants||95% Confidence Interval|Number
780705|NCT00789958|Secondary|2-year Stratum-specific Local Relapse Rate|Local relapse is any evidence of new disease within the primary tumor bed or the regional (retroperitoneal, celiac, and portal vein nodes) lymphatics (these areas are to be encompassed within the radiation fields).|Up to 2 years from registration|Eligible and analyzable patients that received protocol treatment.||percentage of participants||95% Confidence Interval|Number
780706|NCT00789958|Secondary|2-year Disease-free Survival in All Patients|Disease-free survival is calculated from date of registration to date of first documentation of relapse or death due to any cause. Patients last known to be alive are censored at date of last contact.|Up to 2 years from registration|Eligible and analyzable patients that received protocol treatment.||percentage of participants||95% Confidence Interval|Number
780707|NCT00789958|Secondary|2-year Stratum-specific Disease-free Survival|Disease-free survival is calculated from date of registration to date of first documentation of relapse or death due to any cause. Patients last known to be alive are censored at date of last contact.|Up to 2 years from registration|Eligible and analyzable patients that received protocol treatment.||percentage of participants||95% Confidence Interval|Number
780708|NCT00789958|Secondary|2-year Overall Survival for All Patients|Time to death is calculated from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Up to 2 years from registration|Eligible and analyzable patients that received protocol treatment.||percentage of participants||95% Confidence Interval|Number
780709|NCT00789958|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Up to 5 years|Eligible patients who received any treatment and were assessed for adverse events are included in this summary.||Participants|||Number
780710|NCT00789958|Primary|Stratum-specific (R0 and R1) 2-year Overall Survival|Time to death is calculated from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Up to 2 years from registration|Eligible and analyzable patients that received protocol treatment.||percentage of participants||95% Confidence Interval|Number
780711|NCT00789997|Secondary|Number of Participants With Treatment Failure by 90 Days Assignment|In the etanercept group 16/40 (40%) failed treatment compared with 12/38 (32%) in the prednisone group.|Day 0 to Day 90|||participants|||Number
781449|NCT00794677|Secondary|Log(Maximal Plasma Concentration (Cmax) of 7-ketocholesterol) After an Oral Bolus|Log Cmax of 7 ketocholesterol after an oral bolus in patients with primary hypercholesterolemia.|Over 8 hours after 6 weeks of treatment with ezetimibe or placebo|Per protocol||Log(mg/dl)||Standard Error|Mean
780712|NCT00789997|Primary|Change in Lung Function (Forced Expiratory Volume in 1 Second (FEV1)|"FEV1 was obtained using calibrated spirometers at approximately the same time of day at all visits throughout the study. The highest acceptable FEV1 and the highest FVC measurement each obtained on any of three blows (even if not from the same curve) meeting the American Thoracic Society criteria constituted the data for that test set.
Not all participants had Day 14 FEV1 measures collected"|Day 0 to Day 14|||percentage of change in FEV1||Standard Error|Mean
780713|NCT00790023|Secondary|Time to Maximal Effect as Measured by Change From Baseline in the Average AM and PM Reflective Total Nasal Symptoms Scores (rTNSS)|The time to maximal effect is defined as the number of days until the first treatment day on which the estimated difference between Ciclesonide HFA and placebo is at least 90% of the largest estimated difference. This is based on the analyses of change from baseline in the average of AM and PM reflective TNSS scores for each day.|Week 0-2|Intent to Treat Population||days||Standard Error|Least Squares Mean
780714|NCT00790023|Secondary|Onset of Improvement in Instantaneous Total Ocular Symptoms Scores (iTOSS) in Subjects With Baseline iTOSS ≥5.0|"Onset of improvement iTOSS was defined as the first assessment at which iTOSSS for active treatment demonstrated an improvement over placebo from baseline. TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and 9 reflecting more severe symptoms). Instantaneous TOSS symptom scores assess symptoms over the previous 10 minute time interval."|Baseline and up to 48 hours|In Subjects With Baseline iTOSS ≥5.0||Units on a scale||Standard Error|Least Squares Mean
780715|NCT00790023|Secondary|Onset of Improvement in Instantaneous Total Nasal Symptoms Scores (iTNSS)|"Onset of nasal improvement was defined as the first assessment at which iTNSS for active treatment demonstrated an improvement over placebo from baseline.
TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent, 1 = mild, 2 = moderate, 3 = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and 12 reflecting more severe symptoms). Instaneous measures these symptoms over the previous 10 minute time interval."|Baseline and up to 36 hours|Intent to Treat Population. Some participants excluded for missing data.||Units on a scale||Standard Error|Least Squares Mean
780716|NCT00790023|Secondary|Change From Baseline in Overall Score of the Rhinoconjunctivitis Quality of Life Questionnaire With Standard Activities (RQLQ(S)) in Participants With a Baseline Overall Score >= 3.0|The RQLQ(S) in impaired subjects (baseline RQLQ[S] score ≥3.0) at baseline and end of week 2. It consists of 28 questions, each question measured on a scale of 0-6 where a higher score indicates poor quality of life. Domains: Activities (questions 1-3), Sleep (questions 4-6), Non-Nose/Eye Symptoms (questions 7-13), Practical Problems (questions 14-16), Nasal Symptoms (questions 17-20), Eye Symptoms (questions 21-24), and Emotional (questions 25-28). The overall RQLQ(S) score was calculated as the average of the mean domain scores.|Week 0-2|In participants with a Baseline overall score >= 3.0||units on a scale||Standard Error|Least Squares Mean
780717|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported AM and PM iOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0|"OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and 9 reflecting more severe symptoms). Instantaneous OSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline iTOSS ≥5.0||Units on a scale||Standard Error|Least Squares Mean
780718|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported PM iOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0|"OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and 9 reflecting more severe symptoms). Instantaneous OSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline iTOSS ≥5.0||Units on a scale||Standard Error|Least Squares Mean
780719|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported AM iOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0|"OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and 9 reflecting more severe symptoms). Instantaneous OSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline iTOSS ≥5.0||Units on a scale||Standard Error|Least Squares Mean
780720|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported and AM and PM rOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0|"OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and 9 reflecting more severe symptoms). Reflective OSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline rTOSS ≥5.0||Units on a scale||Standard Error|Least Squares Mean
780739|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported AM and PM iTNSS Averaged Over the Two-week Treatment Period.|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|Intent to treat population||units on a scale||Standard Error|Least Squares Mean
780721|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported PM rOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0|"OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and 9 reflecting more severe symptoms). Reflective OSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline rTOSS ≥5.0||Units on a scale||Standard Error|Least Squares Mean
780722|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported AM rOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0|"OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and 9 reflecting more severe symptoms). Reflective OSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline rTOSS ≥5.0||Units on a scale||Standard Error|Least Squares Mean
780723|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported AM and PM iNSS Averaged Over the Two Week Treatment Period|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Instantaneous NSS measures these symptoms over the previous 12-hour time interval. Baseline was the average of the AM and PM responses obtained during the run-in period up to 6 days prior to randomization. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|||Units on a scale||Standard Error|Least Squares Mean
780724|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported PM iNSS Averaged Over the Two Week Treatment Period|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Baseline was the average of the AM and PM responses obtained during the run-in period up to 6 days prior to randomization. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|||Units on a scale||Standard Error|Least Squares Mean
780725|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported AM iNSS Averaged Over the Two Week Treatment Period|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Baseline was the average of the AM and PM responses obtained during the run-in period up to 6 days prior to randomization. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|||Units on a scale||Standard Error|Least Squares Mean
780726|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported AM and PM rNSS Averaged Over the Two Week Treatment Period|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Baseline was the average of the AM and PM responses obtained during the run-in period up to 6 days prior to randomization. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|||Units on a scale||Standard Error|Least Squares Mean
780727|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported PM rNSS Averaged Over the Two Week Treatment Period|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Baseline was the average of the AM and PM responses obtained during the run-in period up to 6 days prior to randomization. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|||Units on a scale||Standard Error|Least Squares Mean
780728|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported AM rNSS Averaged Over the Two Week Treatment Period|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Baseline was the average of the AM and PM responses obtained during the run-in period up to 6 days prior to randomization. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|||Units on a scale||Standard Error|Least Squares Mean
780729|NCT00790023|Secondary|Change From Baseline in Daily Subject Reported AM and PM iTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0|"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TOSS symptom scores assess symptoms over the previous 10 minute time interval. Difference was calculated as week two treatment average – baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline iTOSS ≥5.0||Units on a scale||Standard Error|Least Squares Mean
780755|NCT00790205|Secondary|Percentage of Participants With Initiation of Co-interventional Agent (Per Protocol Population)|In participants not receiving insulin at baseline, time to addition of first co-interventional agent (i.e., next oral antihyperglycemic agent [AHA] or chronic insulin, where chronic insulin therapy is defined as a continuous period of insulin use of more than 3 months.)|Up to 5 years|Per protocol population included all randomized participants who received study medication except those participants who did not contribute at least 1 day of data to the study analysis due to a major protocol violation that excluded all of their data.||Percentage of participants|||Number
780730|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported PM iTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0|"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TOSS symptom scores assess symptoms over the previous 10 minute time interval. Difference was calculated as week two treatment average – baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline iTOSS ≥5.0||Units on a scale||Standard Error|Least Squares Mean
780731|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported AM iTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0|"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TOSS symptom scores assess symptoms over the previous 10 minute time interval. Difference was calculated as week two treatment average – baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline iTOSS ≥5.0||Units on a scale||Standard Error|Least Squares Mean
780732|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported PM rTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0|"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TOSS symptom scores assess symptoms over the previous 12-hour time interval. Difference was calculated as week two treatment average – baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline rTOSS ≥5.0||Units on a scale||Standard Error|Least Squares Mean
780733|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported AM rTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0|"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TOSS symptom scores assess symptoms over the previous 12-hour time interval. Difference was calculated as week two treatment average – baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline rTOSS ≥5.0||Units on a scale||Standard Error|Least Squares Mean
780734|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported PM iTNSS Averaged Over the Two Week Treatment Period|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|||Units on a scale||Standard Error|Least Squares Mean
780735|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported AM iTNSS Averaged Over the Two Week Treatment Period|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|||Units on a scale||Standard Error|Least Squares Mean
780736|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported PM rTNSS Averaged Over the Two Week Treatment Period|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|||Units on a scale||Standard Error|Least Squares Mean
780737|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported AM rTNSS Averaged Over the Two Week Treatment Period|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|||Units on a scale||Standard Error|Least Squares Mean
780738|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported AM and PM rTOSS Averaged Over the Two-week Treatment Period in Participants With a Baseline rTOSS >= 5.0|"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TOSS symptom scores assess symptoms over the previous 12-hour time interval. Difference was calculated as week two treatment average – baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|Intent to treat population. In participants with a baseline rTOSS >= 5.0||units on a scale||Standard Error|Least Squares Mean
780756|NCT00790205|Secondary|Percentage of Participants Who Initiated Chronic Insulin Therapy (Intent to Treat Population)|Chronic insulin therapy is defined as a continuous period of insulin use of more than 3 months.|Up to 5 years|Intent to treat population included all randomized participants who received study medication, provided consent, and did not have a major GCP deviation.||Percentage of participants|||Number
780740|NCT00790023|Primary|Change From Baseline in Daily Subject-reported AM and PM Reflective Total Nasal Symptom Score (rTNSS) Averaged Over the Two-week Treatment Period.|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|Intent to treat population.||units on a scale||Standard Error|Least Squares Mean
780741|NCT00790036|Secondary|Lymphoma-specific Survival (LSS)|LSS was defined as time from randomization to death as a result of lymphoma.|From randomization to death documented as a result of lymphoma up to 7 years|Full Analysis Set (FAS) includes all randomized patients.||Percentage of participants||95% Confidence Interval|Number
780742|NCT00790036|Secondary|Overall Survival (OS)|OS was defined as the time from date of randomization to date of death due to any cause. If the patient was not known to have died, survival was censored at the date of the last contact.|From date of randomization to date of death due to any cause up to around 7 years|Full Analysis Set (FAS) includes all randomized patients.||Percentage of participants||95% Confidence Interval|Number
780743|NCT00790036|Primary|Disease-free Survival (DFS)|DFS was defined as the time from date of randomization to the date of event defined as the first documented relapse of the disease or death due to any cause. Relapse was based on investigator assessment and was assigned only if: It was documented according to Cheson guidelines by an objective radiological assessment method; It was documented by a biopsy proven lymphoma including new or recurrent bone marrow involvement; A new anticancer therapy for lymphoma started with subsequent confirmation of the relapse within 4 weeks of the start of this anticancer therapy|From date of randomization to the date of event defined as the first documented recurrence of the disease, or death due to any cause and up to 6 years|Full Analysis Set (FAS) includes all randomized patients.||Percentage of participants||95% Confidence Interval|Number
780744|NCT00790062|Primary|Risk to Using Increasing Doses of Oxytocin Based on Pre-specified Risk Factors|The frequency of the primary study outcome is examined in a subgroup of 939 women with risk factors for atony or postpartum hemorrhage. These risk factors are identified as White, Hispanic, or Other (non-Black or African American) race/ethnicity, chorioamnionitis, and preeclampsia.|baseline to discharge (2-3 days)|||participants|||Number
780745|NCT00790062|Secondary|Number of Subjects Requiring Hypotension Warranting Pressor Agent or Fluid Bolus|number of individuals with hypotension leading to administration of a fluid bolus or vasopressor agent (medication given to raise the blood pressure)|Initial hospital discharge (2-3 days or more)|||Participants|||Number
780746|NCT00790062|Secondary|Number of Subjects With Hospital Stays Greater Than 4 Days|Number of individuals with prolonged hospitalization defined as 4 days or more prior to initial hospital discharge|Initial hospital discharge (2 days or more)|||Participants|||Number
780747|NCT00790062|Secondary|Number of Participants Experiencing Postpartum Hemorrhage (Clinical Estimate Greater Than 500cc)|the number of individuals with a clinically estimated postpartum blood loss of 500cc or more|Initial hospital discharge (2-3 days)|||Participants|||Number
780748|NCT00790062|Secondary|Number of Participants Experiencing Individual Treatment or Intervention in the Primary Outcome|the number of individuals with each of the component treatments or individual outcomes in the primary composite.|prior to discharge|||Participants|||Number
780749|NCT00790062|Secondary|Change in Pre- to Post-delivery Hematocrit (%)|change in hematocrit from admission for delivery (baseline) to post-delivery (4 hours-1day postpartum depending on time of delivery)|During delivery hospitalization: Admission hematocrit - post-delivery hematocrit|||hematocrit difference (%)||Inter-Quartile Range|Median
780750|NCT00790062|Primary|Women in Each Group With Risk Factors for Atony or Postpartum Hemorrhage|In a secondary data analysis, a parsimonious set of independent risk factors for atony or postpartum hemorrhage was established: White, Hispanic, or Other (non-Black of African American) race/ethnicity, preeclampsia, or chorioamnionitus.|Initial hospital discharge (2-3 days)|||participants|||Number
780751|NCT00790062|Primary|Number of Subjects Reporting Uterine Atony or Postpartum Hemorrhage Requiring Medical (Medication or Blood Transfusion), Surgical or Other Interventional Treatment|the number of subjects with any treatment of uterineatony or hemorrhage.|baseline to discharge (2 - 3 days)|||Participants|||Number
780752|NCT00790192|Secondary|Secondary Outcome: CGI-S From Baseline to the End of the Double-blind Treatment|Clinical Global Impression of Severity is a clinician-rated assessment of the subject's current illness state on a 7 point scale, where a higher score is associated with greater illness severity. The scale has a single item measured on a 7 point scale from 1 (‘normal’, not ill) to 7 (extremely ill).|6-Weeks|||scores on a scale||95% Confidence Interval|Least Squares Mean
780753|NCT00790192|Primary|Primary Efficacy Endpoint: Mean Change in Total PANSS Score From Baseline to the End of the Double Blind Phase|The PANSS (Positive and Negative Syndrome Scale) is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.|Week 6|The primary population for the efficacy analysis was the Intent-to-Treat (ITT) population. All subjects who were randomized, received at least one dose of study medication, and have a Baseline efficacy measurement and at least one post-Baseline efficacy measurement, were in the efficacy analysis in the treatment group to which they were randomized.||scores on a scale||95% Confidence Interval|Least Squares Mean
780754|NCT00790205|Secondary|Percentage of Participants With Initiation of Co-interventional Agent (Intent to Treat Population)|In participants not receiving insulin at baseline, time to addition of first co-interventional agent (i.e., next oral AHA or chronic insulin, where chronic insulin therapy is defined as a continuous period of insulin use of more than 3 months.)|Up to 5 years|Intent to treat population included all randomized participants who received study medication, provided consent, and did not have a major GCP deviation.||Percentage of participants|||Number
780808|NCT00790647|Secondary|Number of Participants Surviving at 2 Years||2 years from transplant|||Participants|||Count of Participants
780757|NCT00790205|Secondary|Percentage of Participants Who Initiated Chronic Insulin Therapy (Per Protocol Population)|Chronic insulin therapy is defined as a continuous period of insulin use of more than 3 months.|Up to 5 years|Per protocol population included all randomized participants who received study medication except those participants who did not contribute at least 1 day of data to the study analysis due to a major protocol violation that excluded all of their data.||Percentage of participants|||Number
780758|NCT00790205|Secondary|Change From Baseline in Urine Albumin:Creatinine Ratio Over Time (Intent to Treat Population)|Change from baseline reflects the difference between the urine albumin:creatinine ratio reported time point and baseline value.|Baseline and up to 5 years|Intent to treat population included all randomized participants who received study medication, provided consent, and did not have a major GCP deviation. Number of participants analyzed consists of those participants in the intent to treat population with a baseline value for the outcome measure.||g/mol Creatinine||Standard Deviation|Mean
780759|NCT00790205|Secondary|Change From Baseline in Urine Albumin:Creatinine Ratio Over Time (Per Protocol Population)|Change from baseline reflects the difference between the urine albumin:creatinine ratio reported time point and baseline value.|Baseline and up to 5 years|Per protocol population included all randomized participants who received study medication except those participants who did not contribute at least 1 day of data to the study analysis due to a major protocol violation that excluded all of their data. Number of participants analyzed consists of those participants with a baseline value.||g/mol Creatinine||Standard Deviation|Mean
780760|NCT00790205|Secondary|Change From Baseline in HbA1c Over Time (Intent to Treat Population)|HbA1c is a measure of the percentage of glycated hemoglobin in the blood. Estimated mean difference between sitagliptin and placebo controlling for baseline HbA1c and region.|Baseline and up to 4 years|Intent to treat population included all randomized participants who received study medication, provided consent, and did not have a major GCP deviation. Number of participants analyzed consists of those participants in the intent to treat population with a baseline value.||Percentage of HbA1c||Standard Deviation|Mean
780761|NCT00790205|Secondary|Change From Baseline in HbA1c Over Time (Per Protocol Population)|HbA1c is a measure of the percentage of glycated hemoglobin in the blood. Estimated mean difference between sitagliptin and placebo controlling for baseline HbA1c and region.|Baseline and up to 4 years|Per protocol population included all randomized participants who received study medication except those participants who did not contribute at least 1 day of data to the study analysis due to a major protocol violation that excluded all of their data. Number of participants analyzed consists of those participants with a baseline value.||Percentage of HbA1c||Standard Deviation|Mean
780762|NCT00790205|Secondary|Change From Baseline in Renal Function Over Time (Intent to Treat Population)|Change in renal function based on eGFR using the MDRD method.|Baseline and up to 5 years|Intent to treat population included all randomized participants who received study medication, provided consent, and did not have a major GCP deviation. Number of participants analyzed consists of those participants with a baseline value.||mL/min/1.73 m^2||Standard Deviation|Mean
780763|NCT00790205|Secondary|Change From Baseline in Renal Function Over Time (Per Protocol Population)|Change in renal function based on estimated glomerular filtration rate [eGFR] using the Modification of Diet in Renal Disease [MDRD] method.|Baseline and up to 5 years|Per protocol population included all randomized participants who received study medication except those participants who did not contribute at least 1 day of data to the study analysis due to a major protocol violation that excluded all of their data. Number of participants analyzed consists of those participants with a baseline value.||mL/min/1.73 m^2||Standard Deviation|Mean
780764|NCT00790205|Secondary|Percent Incidence of CHF Requiring Hospitalization (Intent to Treat Population)|Percent incidence of CHF requiring hospitalization was reported as the percentage of participants who were admitted to the hospital for CHF.|Up to 5 years|Intent to treat population included all randomized participants who received study medication, provided consent, and did not have a major GCP deviation.||Percentage of participants|||Number
780765|NCT00790205|Secondary|Percent Incidence of Congestive Heart Failure (CHF) Requiring Hospitalization (Per Protocol Population)|Percent incidence of CHF requiring hospitalization was reported as the percentage of participants who were admitted to the hospital for CHF.|Up to 5 years|Per protocol population included all randomized participants who received study medication except those participants who did not contribute at least 1 day of data to the study analysis due to a major protocol violation that excluded all of their data.||Percentage of participants|||Number
780766|NCT00790205|Secondary|Percent Incidence of All-cause Mortality (Intent to Treat Population)|Percent incidence of all-cause mortality is reported as the percentage of participants who died due to any cause.|Up to 5 years|Intent to treat population included all randomized participants who received study medication, provided consent, and did not have a major GCP deviation.||Percentage of participants|||Number
780767|NCT00790205|Secondary|Percent Incidence of All-cause Mortality (Per Protocol Population)|Percent incidence of all-cause mortality is reported as the percentage of participants who died due to any cause.|Up to 5 years|Per protocol population included all randomized participants who received study medication except those participants who did not contribute at least 1 day of data to the study analysis due to a major protocol violation that excluded all of their data.||Percentage of participants|||Number
780768|NCT00790205|Secondary|Percentage of Participants With First Confirmed CV Event of MACE (Intent to Treat Population)|CV composite endpoint of MACE which includes CV-related death, nonfatal MI, or nonfatal stroke.|Up to 5 years|Intent to treat population included all randomized participants who received study medication, provided consent, and did not have a major GCP deviation.||Percentage of participants|||Number
780769|NCT00790205|Secondary|Percentage of Participants With First Confirmed CV Event of MACE (Per Protocol Population)|CV composite endpoint of MACE which includes CV-related death, nonfatal MI, or nonfatal stroke.|Up to 5 years|Per protocol population included all randomized participants who received study medication except those participants who did not contribute at least 1 day of data to the study analysis due to a major protocol violation that excluded all of their data.||Percentage of participants|||Number
780770|NCT00790205|Primary|Percentage of Participants With First Confirmed CV Event of Major Adverse Cardiovascular Event (MACE) Plus (Intent to Treat Population)|Primary composite CV endpoint of MACE plus which includes CV-related death, nonfatal MI, nonfatal stroke, or unstable angina requiring hospitalization.|Up to 5 years|Intent to treat population included all randomized participants who received study medication, provided consent, and did not have a major GCP deviation.||Percentage of participants|||Number
780771|NCT00790205|Primary|Percentage of Participants With First Confirmed Cardiovascular (CV) Event of Major Adverse Cardiovascular Event (MACE) Plus (Per Protocol Population)|Primary composite CV endpoint of MACE plus which includes CV-related death, nonfatal MI, nonfatal stroke, or unstable angina requiring hospitalization.|Up to 5 years|Per protocol population included all randomized participants who received study medication except those participants who did not contribute at least 1 day of data to the study analysis due to a major protocol violation that excluded all of their data.||Percentage of participants|||Number
780772|NCT00790218|Primary|Maximum Tolarated Dose|The MTD was defined as the highest dose level at which < 2 of 6 patients developed Cycle 1 DLT.|first 28 days (Cycle 1)||||||
780773|NCT00790218|Secondary|Relationship Between Biomarkers of Peripheral Blood Mononuclear Cell (PBMC) Adenosine A3 Receptor (A3AR) Expression and Clinical Effects of CF102||Baseline||||||
780774|NCT00790218|Secondary|Therapeutic Effect of CF102 in Hepatocellular Carcinoma||Every 2 months||||||
780775|NCT00790218|Primary|Repeat-dose Pharmacokinetic Behavior of CF102||1 month||||||
780776|NCT00790218|Primary|Dose Limiting Toxicity|Dose-limiting toxicity was defined as a clinically significant AE or laboratory abnormality occurring in Cycle 1|From start of treatment until Day 28 of Cycle 1|||participants|||Number
780777|NCT00790270|Secondary|Resumption of Work or School|number of patients resuming regular activity the day following enrollment.|next day|||participants|||Number
780778|NCT00790270|Primary|Use of Rescue Medications|the number of patients taking additional rescue medications beyond the study meds|24 hours|number of patients using additionl anlagesics on the day following enrollment||participants|||Number
780779|NCT00790270|Secondary|Time to Resumption of Work||1 week||||||
780780|NCT00790270|Primary|Pain||Daily for 1 week||||||
780781|NCT00790296|Primary|Change in Visual Analog Scale for Energy (VAS-E)Score From Baseline to 7 Hrs Post Study Medication Infusion|1 to 100 scale with 1 referring to No Energy and 100 referring to Normal Energy.|Baseline and 7 hours post study medication infusion|||Scores on a scale||Standard Deviation|Mean
780782|NCT00790400|Secondary|Duration of Skin Lesion Response - Only Everolimus Patients With Best Overall Skin Lesion Response of Complete Clinical Response (CCR) or Partial Response (PR)|Duration of skin lesion response is defined as the time from the date of the first skin lesion response until the date of the first skin lesion progression, according to the PGA (physician’s global assessment of clinical condition). A progression is when the disease is worse than at baseline evaluation by >=25% or more.|From date of randomization until the earliest date of first documented AML progression, date of further anti-AML medication (including open-label Everolimus)/surgery or up to about 5.7 years|The analysis was performed on the Full analysis Set for patients in Everolimus arm and who experienced a best overall skin lesion response CCR or PR.||months||95% Confidence Interval|Median
780783|NCT00790400|Secondary|Duration of Angiomyolipoma Response - Only Everolimus Patients With Angiomyolipoma Response|Duration of angiomyolipoma response was defined as the time from the date of the first documented angiomyolipoma response until the date of the first documented angiomyolipoma progression . Angiomyolipoma response was defined as the combination of the following criteria: reduction in angiomyolipoma volume of ≥ 50% relative to baseline, where angiomyolipoma volume was sum of volumes of all target lesions identified at baseline, and with a confirmatory scan performed approximately 12 weeks later (no sooner than 8 weeks later); no new angiomyolipoma lesions ≥ 1.0 cm in longest diameter were identified; there were no kidney increases in volume > 20% from nadir. The patient did not have any angiomyolipoma-related bleeding of ≥ grade 2.|From date of randomization until the earliest date of first documented AML progression, date of further anti-AML medication (including open-label Everolimus)/surgery or up to about 5.7 years|The analysis was performed on the Full analysis Set for patients in Everolimus arm and who experienced an angiomyolipoma response.||months||95% Confidence Interval|Median
780784|NCT00790400|Secondary|Time to Angiomyolipoma Response - Only Everolimus Patients With Angiomyolipoma Response|"Time to angiomyolipoma response was defined as the time from the date of randomization until the date of the first documented angiomyolipoma response. Angiomyolipoma response defined as the combination of the following criteria: reduction in angiomyolipoma volume of ≥ 50% relative to baseline, where angiomyolipoma volume was sum of volumes of all target lesions identified at baseline, and with a confirmatory scan performed approximately 12 weeks later (no sooner than 8 weeks later); no new angiomyolipoma lesions ≥ 1.0 cm in longest diameter were identified; no kidney increases in volume > 20% from nadir; no angiomyolipoma-related bleeding of ≥ grade 2.
For the everolimus (core/extension periods) treatment group, the time to angiomyolipoma response is from the start of everolimus. The baseline in the response definition means the latest value on or before starting everolimus."|From date of randomization until the earliest date of first documented AML progression, date of further anti-AML medication (including open-label Everolimus)/surgery or up to 5.7 years|The analysis was performed on the Full analysis Set for patients in Everolimus arm and who experienced an angiomyolipoma response.||months||95% Confidence Interval|Median
780785|NCT00790400|Secondary|Everolimus Blood Concentrations (C2h) at 2 Hours Post-dose|C2h values collected 1-3 hours after dose administration on the same study day, at steady state, and patient did not vomit between taking previous dose and blood collection. Samples collected during the first 4 days of dosing will be excluded from all analyses.|2 hours post-dose administration at Weeks 2, 4, 12, 24, 48|The analysis was performed in the Safety Set population for patients treated only with Everolimus and with a confirmed PK sample.||ng/mL||Standard Deviation|Mean
780786|NCT00790400|Secondary|Everolimus Trough Concentrations (Cmin)|Cmin values collected prior to dose administration on the same study day and at 20-28 hours after previous dose, at steady state, and patient did not vomit within 4 hours of previous dose. Samples collected during the first 4 days of dosing were excluded from all analyses.|Prior to dosing at weeks 2, 4, 12, 24, 48|The analysis was performed in the Safety Set population for patients treated only with Everolimus and with a confirmed PK sample.||ng/mL||Standard Deviation|Mean
780787|NCT00790400|Secondary|Change From Baseline in Plasma Angiogenic Molecules - Vascular Endothelial Growth Factor (VEGF) Marker|Blood samples for biomarker assessment were collected immediately prior to study administration. On-treatment samples was compared to baseline samples with the change from baseline.|4 weeks, 12 weeks, 24 weeks, 36 weeks 48 weeks, 60 weeks, 72 weeks|The Full Analysis Set (FAS) is defined according to the Intention-to-Treat principle and consists of all randomized patients. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||pg/mL||Standard Deviation|Mean
780788|NCT00790400|Secondary|Percentage of Participants With Renal Impairment|Renal Impairment was measured by glomerular filtration rate which was calculated using the Modification of Diet in Renal Disease formula. Percentage of participants with renal impairment was reported. Severe renal impairment was defined as a GFR of <30ml/min/1.73m2.|Day 1 up to 28 days after end of treatment|Safety set consists of all patients who received at least 1 dose of the double-blind study drug with a valid post-baseline assessment. For the everolimus (core/extension) treatment arm, patients received at least 1 dose of everolimus with a valid post-baseline assessment, where baseline was defined as the assessment just before start of everolimus.||Percentage of Participants|||Number
780789|NCT00790400|Secondary|Skin Lesion Response Rate as Per Investigator (Only Patients With at Least One Skin Lesion at Baseline)|Skin lesion response rate in the double-blind period was determined only among patients with at least one skin lesion at baseline, and is the percentage of this group of patients with a best overall skin lesion response on the Physician’s Global Assessment of Clinical Condition (PGA) of either complete clinical response (CCR) or partial response (PR). A complete clinical response (CCR) requires a grading of 0 indicating the absence of disease (histological confirmation is not required). Grades 1, 2, and 3 constitute partial response, indicating improvement of at least 50 percent, but less than 100 percent improvement. For the everolimus (core/extension periods) treatment group, the baseline means the latest value on or before starting everolimus.|From date of randomization until the earliest date of first documented AML progression, date of further anti-AML medication (including open-label Everolimus)/surgery or up to 5.7 years|The Full Analysis Set (FAS) is defined according to the Intention-to-Treat principle and consists of all randomized patients. Only patients with at least one skin lesion at baseline are included in the analysis.||Percentage of participants||95% Confidence Interval|Number
780790|NCT00790400|Secondary|Time to Angiomyolipoma Progression as Per Central Radiology Review|"Time to angiomyolipoma progression (TTAP) is defined as time from date of randomization to date of first documented angiomyolipoma progression. Angiomyolipoma progression was defined as one or more of the following: Increase from nadir of ≥ 25% in angiomyolipoma volume to value greater than baseline; the appearance of a new angiomyolipoma ≥ 1.0 cm in longest diameter; an increase from nadir of 20% or more in the volume of either kidney to a value greater than baseline; angiomyolipoma-related bleeding grade ≥ 2.
For the everolimus (core/extension periods) treatment group, the time to angiomyolipoma progression is defined starting from the start of everolimus. The baseline means the latest value on or before starting everolimus."|From date of randomization until the earliest date of first documented AML progression, date of further anti-AML medication (including open-label Everolimus)/surgery or up to about 5.7 years|The Full Analysis Set (FAS) is defined according to the Intention-to-Treat principle and consists of all randomized patients.||months||95% Confidence Interval|Median
780791|NCT00790400|Primary|Angiomyolipoma Response Rate as Per Central Radiology Review|"Angiomyolipoma response defined as the combination of the following criteria: reduction in angiomyolipoma volume of ≥ 50% relative to baseline, where angiomyolipoma volume was sum of volumes of all target lesions identified at baseline, and with a confirmatory scan performed approximately 12 weeks later (no sooner than 8 weeks later); no new angiomyolipoma lesions ≥ 1.0 cm in longest diameter were identified; there were no kidney increases in volume > 20% from nadir. The patient did not have any angiomyolipoma-related bleeding of ≥ grade 2.
For the everolimus (core/extension periods) treatment group, the baseline means the latest value on or before starting everolimus."|From date of randomization until the earliest date of first documented AML progression, date of further anti-AML medication (including open-label Everolimus)/surgery or up to 5.7 years|The Full Analysis Set (FAS) is defined according to the Intention-to-Treat principle and consists of all randomized patients.||Percentage of Participants||95% Confidence Interval|Number
780792|NCT00790452|Primary|Frequency of VTE Events|Occurrences of Venous Thromboembolism (VTE) events in each study arm of a randomized placebo controlled trial of aspirin in GBM Patients.|VTE evaluation with study visits (4 weeks) for up to 2 years|Analysis was to be per protocol, study terminated early with no analysis. Only enrolled participant to the study was prematurely taken off the study due to a drug supply issue.||participants|||Number
780793|NCT00790556|Other Pre-specified|Hepatic Glucose Production (HGP) at Baseline||Baseline|Subjects who discontinued were not used in the analysis.||mg/kg/min||Standard Deviation|Mean
780794|NCT00790556|Primary|Mean Change From Baseline in Hepatic Glucose Production (HGP) at Day 14|Changes in HGP were determined during a euglycemic clamp procedure. HGP was evaluated as milligrams per kilogram of glucose produced per minute.|Day 14 of each 14-day Treatment Period|Subjects who discontinued were not used in the analysis.||mg/kg/min||Standard Deviation|Mean
780795|NCT00790556|Primary|Number of Participants Experiencing Clinical and Laboratory Adverse Events (CAEs and LAEs)|"An LAE is defined as any unfavorable & unintended change in the chemistry of the body temporally associated with the use of study product, whether or not considered related to the use of the product. A CAE is defined similarly but also includes changes in structure or function of the body.
Serious AEs are those occuring that result in one or more of the pre-specified outcome(s) that meet the criteria of seriousness, including death, life-threatening, significant disability, or hospitalization, etc.
Drug-relatedness was determined by the investigator based on clinical judgement."|56 days|All 14 subjects enrolled in the study were included in the assessment of safety and tolerability (although only 12 subjects received placebo, our database includes all subjects in the analysis).||participants|||Number
780811|NCT00790647|Primary|Number of Participants With Hematologic Response|"complete and partial hematologic response defined as: Complete response: absence of detectable monoclonal protein in serum and urine, and bone marrow biopsy <5% plasma cells with no clonal predominance of kappa or lambda isotype.
Partial response: any one of the following
For patients with detectable and quantifiable marrow plasmacytosis, a reduction of 50% or more in plasma cells as a percentage of nucleated bone marrow cells.
For patients with a detectable monoclonal peak on serum protein electropheresis or urine protein electropheresis, a reduction in the peak height of 50% or more.
For patients with quantifiable urinary kappa or lambda chain concentration, a reduction in daily light chain excretion (concentration x 24-hr urine volume)."|one year|||participants|||Number
780812|NCT00790673|Secondary|Evaluation of the Relationship Between Biomarkers of Peripheral Blood Mononuclear Cell Adenosine 3 Receptor (A3R) Expression and Clinical Effects||16 weeks||||||
780813|NCT00790673|Primary|Pharmacokinetic Behavior of CF102 During Repeated Dosing||16 weeks||||||
780814|NCT00790673|Primary|Effect of Viral Load||16 weeks||||||
780815|NCT00790673|Primary|Adverse Event Profile of Repeated Dosing of CF102||16 weeks|||participants|||Number
780816|NCT00790738|Secondary|Clinical Global Impression Scores|The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. At the time of rating patients are rated as: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.|8 weeks|||units on a scale||Standard Deviation|Mean
780817|NCT00790738|Secondary|Clinician-Administered Rating Scale for Mania|The Clinician-Administered Rating Scale for Mania (CARS-M) contains 15 items rated from 0-5 or 0-6 on a Likert scale. It was developed to assess severity of manic symtoms. The scale ranges from 0 to 50, and the following thresholds are used: severe ≥26, moderate 16-25, mild 8-15 and normal ≤7.|8 weeks|||units on a scale||Standard Deviation|Mean
780818|NCT00790738|Primary|Hamilton Rating Scale for Depression Scores|The Hamilton Rating Scale for Depression (HRSD) is a checklist of items ranked from 0-4 or 0-2, that was designed to measure the severity of depressive symptoms. The scale ranges from 0 to 50, and the following thresholds are used: very severe >23, severe 19-22, moderate 14-18, mild 8-13 and normal ≤7.|8 weeks|||units on a scale||Standard Deviation|Mean
780819|NCT00790751|Primary|Change in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Score|Questionnaire assesses subject's evaluation of erectile function over the previous 4-week period. Total score from questions 1-5 & 15 ranges from 1 to 30. A higher score indicates better erectile function.|Baseline, End of Treatment (up to 12 weeks)|Number of participants analyzed represents the Intent-to-Treat population. For dropouts or missing data, the last observation carried forward convention was used.||scores on a scale||Standard Error|Least Squares Mean
780820|NCT00790751|Primary|Change in Percentage of Sexual Attempts in Which Subjects Were Able to Insert the Penis Into the Partner's Vagina|"Data presented as mean change from baseline in the percentage of Yes responses to Sexual Encounter Profile (SEP) diary question 2 Were you able to insert your penis into your partner's vagina?"|Baseline, 12 weeks|Number of participants analyzed represents the Intent-to-Treat population.||percentage of sexual attempts||Standard Error|Least Squares Mean
780821|NCT00790751|Primary|Change in Percentage of Sexual Attempts in Which Subjects Were Able to Maintain an Erection of Sufficient Duration to Have Successful Intercourse|"Data presented as mean change from baseline in the percentage of Yes responses to Sexual Encounter Profile (SEP) diary question 3 Did your erection last long enough for you to have successful intercourse?"|Baseline, 12 weeks|Number of participants analyzed represents the Intent-to-Treat population.||percentage of sexual attempts||Standard Error|Least Squares Mean
780822|NCT00790790|Secondary|Time to Response|Time to response=first visit achieving a 30% reduction of weekly mean 24-hour APS score. Data were recorded daily (preferably at bedtime) on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The number of days at which 30% of the participants at risk had at least 30% response was reported.|Baseline through 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.||Time (days)|||Number
780823|NCT00790790|Secondary|Number of Participants With Neurological Treatment Emergent Adverse Events (AEs)|"The total number of TEAEs (serious and non-serious) that first occurred or worsened during the treatment period) from the Nervous system disorders system organ class was summarized. A listing of serious and other non-serious AEs is located in the Reported Adverse Event module."|Baseline through 5 weeks|The safety analysis population included all 147 participants randomized to study drug.||participants|||Number
780824|NCT00790790|Secondary|Pharmacokinetic (PK) Parameter: Clearance of LY545694 (CLp) and Compound 645838 (CLm)|Clearance was the volume of plasma cleared of study drug LY545694 (CLp) and metabolite compound 645838 (CLm) per unit time. The original PK/pharmacodynamic (PD) relationship outcome measure analysis was not conducted; therefore, only PK data were reported.|Baseline through 5 weeks|The PK dataset for population modeling consisted of quantifiable plasma LY545694 and Compound 64538 concentrations from participants following daily oral doses of LY545694 21 mg to LY545694 105 mg.||Liter per hour (L/hr)||95% Confidence Interval|Geometric Mean
780825|NCT00790790|Secondary|Number of Participants Reporting Blurry or Hazy Vision Using the Subjective Vision Inventory (SVI) Question 1 (Q1) at 5 Weeks|This scale first asked if the participant was experiencing hazy or blurry vision or if he/she had difficulty focusing. If the answer was yes, followup questions rated the degree to which the issue impaired his/her ability to do work or read.|Week 5|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.||participants|||Number
780826|NCT00790790|Secondary|Number of Participants With Electrocardiogram (ECG) Change in Heart Rate Using Bazett's (QTcB) and Fridericia's (QTcF) Formulas|The number of participants having QTcF and QTcB ECG change >450 milliseconds (msec) was summarized.|Baseline through 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.||participants|||Number
780827|NCT00790790|Secondary|Change From Baseline in Vital Signs: Pulse Rate at 5 Weeks|Pulse rate was measured in beats per minute (bpm). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.||beats per minute (bpm)||Standard Error|Least Squares Mean
780828|NCT00790790|Secondary|Change From Baseline in Vital Signs: Systolic Blood Pressure and Diastolic Blood Pressure at 5 Weeks|Participants' systolic blood pressure and diastolic blood pressure were measured in millimeters of mercury (mmHg). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
780829|NCT00790790|Secondary|Number of Participants With Serious Treatment Emergent Abnormal High or Low Laboratory Values|"The number of participants by treatment group who had abnormal high or low laboratory values was summarized as serious adverse events (SAEs) from the Investigations system organ class during the treatment phase of the study. A listing of SAEs is located in the Reported Adverse Event module."|Baseline through 5 weeks|The safety analysis population included all 147 participants randomized to study drug.||participants|||Number
780830|NCT00790790|Secondary|Number of Participants Who Discontinued Due to Treatment Emergent Adverse Events (TEAEs) During the Therapy Phase and 1-Week Washout Phase|Participant discontinuation in the study due to serious and other non-serious AEs was measured during both the therapy (double-blind) phase and 1-week washout (follow-up) phase. A listing of serious and other non-serious AEs is located in the Reported Adverse Event module.|Baseline through 6 weeks|The safety analysis population included all 147 participants randomized to study drug.||participants|||Number
780831|NCT00790790|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Global Impairment Score at 5 Weeks|The SDS was completed by the participant and was used to assess the effect of the participant's symptoms on their work/social/family life. Total scores ranged from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.||units on a scale||Standard Error|Least Squares Mean
780832|NCT00790790|Secondary|Change From Baseline in European Quality of Life Scale - 5 Dimensions (EQ-5D) at 5 Weeks: United States Population Based Index Score|The EuroQoL Questionnaire - 5 Dimension (EQ-5D) was a generic, multidimensional, health-related, quality-of-life instrument. The profile allowed participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 was generated for each domain. For each participant, the outcome rating on the 5 domains was mapped to a single index through an algorithm. The index ranged between 0 and 1, with the higher score indicating a better health state perceived by the participant.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.||units on a scale||Standard Error|Least Squares Mean
780833|NCT00790790|Secondary|Change From Baseline in Short Form-36 (SF-36) Health Survey Bodily Pain Score at 5 Weeks|The SF-36 Health Status Survey was a generic, health-related scale assessing participants' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). MCS and PCS scores=0-100 (higher scores indicated better health status). Domain scores: general health=5-25; physical functioning=10-30; role-physical=4-8; role-emotional=3-6; social functioning=2-10; bodily pain=2-11; vitality=4-24; mental health=5-30.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.||units on a scale||Standard Error|Least Squares Mean
780834|NCT00790790|Secondary|Change From Baseline in Total Western Ontario and MacMaster (WOMAC) Osteoarthritis Physical Function, Pain, and Stiffness Subscales at 5 Weeks|The Total WOMAC index (pain, stiffness, physical function subscales) was completed by the participant and had 24 questions. Each question was answered using a 5-point Likert scale (0 to 4). The Total score had a range from 0 (none) to 96 (extreme). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.||units on a scale||Standard Error|Least Squares Mean
780835|NCT00790790|Secondary|Change From Baseline in Assessment of Sleep Questionnaire (ASQ) Total Score at 5 Weeks|ASQ consisted of 21 items (including a single item to assess overall sleep quality) and 3 subscales: Sleep Onset and Maintenance (items 1-3, 5-6, 9, 11); Sleep Experience (items 4, 7, 8, 10, 12); and Awakening Experience (items 13-20). Each item was scored on a 5-point Likert scale, ranging from 0 (no sleep at all) to 5 (a lot of sleep). Each subscale was calculated as the mean of the individual items comprising the subscale. A total ASQ score was calculated as the mean of the subscale scores; higher scores represented better sleep.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.||units on a scale||Standard Error|Least Squares Mean
780836|NCT00790790|Secondary|Patient Global Impression of Improvement (PGI-I) Score at 5 Weeks|PGI-I was a scale that measured the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranged from 1 (very much better) to 7 (very much worse). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Week 5|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.||units on a scale||Standard Error|Least Squares Mean
780837|NCT00790790|Secondary|Change From Baseline in Brief Pain Inventory - Severity (BPI-S) Subscale Score at 5 Weeks|BPI-S was a self-reported scale measuring severity of pain. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessed worst pain, least pain, and average pain in past 24 hours, and current pain. LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 Weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.||units on a scale||Standard Error|Least Squares Mean
780838|NCT00790790|Secondary|Change From Baseline in Average Brief Pain Inventory - Interference (BPI-I) Subscale Score at 5 Weeks|Average BPI-I was a self-reported scale measuring degree of pain interference on function. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessed interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items. LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.||units on a scale||Standard Error|Least Squares Mean
780839|NCT00790790|Secondary|Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at 5 Weeks|CGI-S measured severity of illness at the time of assessment compared with start of treatment. Scores ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.||units on a scale||Standard Error|Least Squares Mean
780840|NCT00790790|Secondary|Number of Participants With 30% Reduction in Weekly Mean 24-hour Average Pain Severity (APS) Score|This scale measured 24-hour APS scores. Data were recorded daily (preferably at bedtime) on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point Likert scale was also used for assessment of night pain and worst pain each day, evaluated as weekly means.|Baseline through 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure. LOCF was conducted on the primary efficacy measure modified ITT population.||participants|||Number
780841|NCT00790790|Secondary|Change From Baseline in Weekly Mean Worst Daily Pain Severity Score From Electronic Diary at 5 Weeks|This scale measured worst pain APS scores. Data were recorded daily (preferably at bedtime) on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.||units on a scale||Standard Error|Least Squares Mean
780842|NCT00790790|Secondary|Change From Baseline in Weekly Mean Night Pain Severity Score From Electronic Diary at 5 Weeks|This scale measured night pain APS scores. Data were recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.||units on a scale||Standard Error|Least Squares Mean
780843|NCT00790790|Primary|Change From Baseline in Weekly Mean 24-hour Average Pain Severity (APS) Score From Electronic Diary at 5 Weeks|This scale measured 24-hour APS scores. Data were recorded daily (preferably at bedtime) on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Least Squares (LS) Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure. Last observation carried forward (LOCF) was conducted on the primary efficacy measure modified ITT population.||units on a scale||Standard Error|Least Squares Mean
780844|NCT00790803|Secondary|Change in Immunomodulatory Medications (Topical, Periocular or Systemic) After the Initiation of Macugen Therapy|No changes were to be made in immunodulatory medications of the patients unless needed for safety after in initiation of Macugen therapy.|32 weeks|||participants|||Number
780845|NCT00790803|Secondary|A Decrease in Anterior Chamber Cells or Vitreous Cells or Haze in Injected Eye|"The degree of cell and flare was recorded at each visit during the course of the trial in the injected eye.
In uveitis, severely inflamed vessels leak protein which clouds the normally clear aqueous. This looks hazy with the slit lamp. If severe, it disperses the light beam, causing flare.
White or red blood cells may be observed: the presence of inflammatory cells in the anterior chamber suggests inflammation of the iris and ciliary body.
Blood cells: grading of blood cells in the anterior chamber is as follows:
0 - None.
1+ - faint (barely detectable).
2+ - moderate (clear iris and lens details).
3+ - moderate (hazy iris and lens details).
4+ - intense (fibrin deposits, coagulated aqueous)."|32 weeks|||participants|||Number
780846|NCT00790803|Secondary|Decrease in CME as Evidenced by Imaging (Fluorescein Angiography and 50 Micron Change in OCT)|Patients retinal thickness was measured at each visit bu imaging to monitor increase or decrease in thickness.|32 weeks|||participants|||Number
780847|NCT00790803|Secondary|Proportion of Patients Experiencing > 0 Letter Vision Gain and a < 15 Loss|Patients best corrected visual acuity was measured at each visit to monitor gain or loss of letters on the EDTRS chart.|32 weeks|||paticipants|||Number
780848|NCT00790803|Primary|Improvement in VA ETDRS >/= 15 Letters|The primary outcome was an improvement in VA greater than or equal to fifteen letters on the EDTRS chart.|32 weeks|Five consecutive adult patients with non-infectious uveitis associated CME were chosen from the PI's regular medical clinic. Patients demonstrated, on fluorescein angiogram and/or optical tomography, bilateral or unilateral CME with non-infectious uveitis for greater than three months, but less than twelve.||participants|||Number
780849|NCT00790855|Secondary|Number of Participants With a Response|A complete response (CR) is defined as normalization of the bone marrow and peripheral blood counts with </= 5% marrow blasts in a normo-or hypercellular marrow, with a granulocyte count of >/= 10^9/L and a platelet count of >/=100 X 10^9/L. A partial response (PR) was defined as for CR, but with only >/=50% reduction of marrow blasts and to a range of 6%-25%. A marrow complete response was defined as a reduction of marrow blasts to </=5% but without recovery of peripheral counts.|1 - 24 week cycles (up to 8 weeks)|||participants|||Number
780850|NCT00790855|Primary|Maximum Tolerated Dose (MTD)|The MTD is the highest dose level in which <2 patients of 6 develop first cycle dose limiting toxicity (DLT). MTD assessed during course 1 (4 week cycle), every 3-7 days.|During course 1 (4 week cycle)|||mg/m^2|||Number
780851|NCT00790907|Secondary|Number of Participants Experiencing Death, MI, TVR, Definite/Probable Stent Thrombosis, or Stroke, Assessed Separately During the Peri-PCI Period and at Day 30|The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Assessment of death, MI, TVR, definite/probable stent thrombosis, or stroke was performed during the peri-PCI period and at Day 30. MI, TVR, definite/probable stent thrombosis, and stroke events were adjudicated by a blinded CIAC.|Peri-PCI (during the time from randomization up to 48 hours after the end of PCI, typically 49 hours total) and from randomization up to Day 30|ITT Population||participants|||Number
780852|NCT00790907|Secondary|Number of Participants With Composite of Death, MI or TVR During the Peri-PCI Period and at Day 30|The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Assessment of composite of death, MI, or TVR was performed both during the peri-PCI period and at Day 30. MI and TVR events were adjudicated by a blinded CIAC.|Peri-PCI (during the time from randomization up to 48 hours after the end of PCI, typically 49 hours total) and from randomization up to Day 30|ITT Population||participants|||Number
780853|NCT00790907|Secondary|Number of Participants With Major PCI-related Procedural Complications|Major PCI-related procedural complications included: abrupt vessel closure, a new angiographic filling defect representing either angiographic thrombus or major dissection with reduced flow, no-reflow phenomenon, or catheter-related thrombus. Investigator reports of catheter-related thrombus were defined as suspected catheter-related thrombus events, and were adjudicated by a blinded CIAC.|During PCI procedure: immediately after randomization (approximately 10-75 minutes)|ITT Population||participants|||Number
780854|NCT00790907|Secondary|Number of Participants With Major Vascular Access Site Complications During the Peri-PCI Period|The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Major vascular access site complications included: large hematoma, pseudoaneurysm requiring treatment, arterio-venous fistula, or other vascular procedures related to the access site.|Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total)|ITT Population||participants|||Number
780855|NCT00790907|Secondary|Number of Participants With Minor Bleeding During the Peri-PCI Period|The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Minor bleeding events were adjudicated by a blinded CIAC.|Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total)|ITT Population||participants|||Number
780856|NCT00790907|Secondary|Number of Participants With Major Bleeding During the Peri-PCI Period|The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Major bleeding, MI and TVR were adjudicated by a blinded CIAC.|Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total)|ITT Population||participants|||Number
780857|NCT00790907|Secondary|Number of Participants With Composite of Major Bleeding During the Peri-PCI Period, With Death, MI, or TVR at Day 30|The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Assessment of death, myocardial infarction (MI) and target vessel revascularisation (TVR) was performed at Day 30. Major bleeding, MI and TVR were adjudicated by a blinded CIAC.|Peri-PCI period for major bleeding (during the time from randomization up to 48 hours after the end of PCI [typically 49 hours total] ) and from randomization up to Day 30 for death, MI, or TVR|ITT Population||participants|||Number
780858|NCT00790907|Primary|Number of Participants With Composite of Major Bleeding, Minor Bleeding, or Major Vascular Access Site Complications During the Peri-PCI Period|The peri-percutaneous coronary intervention (peri-PCI) period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Major and minor bleeding events were adjudicated by a blinded central independent adjudication committee (CIAC). Major vascular access site complications comprised large hematoma, pseudoaneurysm requiring treatment, aterio-venous fistula, or other vascular procedures related to the access site.|Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total)|Intent-to-Treat (ITT) Population: all randomized participants||participants|||Number
780859|NCT00791037|Secondary|Response of Skeletal or Bone-only Disease by FDG-PET and According to European Organization for Research and Treatment for Cancer (EORTC)||Up to 2 years|Due to getting regulatory approvals we could only enroll 1 patient in this part of the protocol||Participants|||Count of Participants
780860|NCT00791037|Secondary|Development of CD4+ and CD8+ Epitope Spreading|As assessed by the development of immunity to epitopes within the HER2 protein to which the patient was not vaccinated as well as the development of immunity to other breast cancer related tumor antigens.|Up to 2 years|||Participants|||Count of Participants
780861|NCT00791037|Secondary|Proportion of Patients Whose T Cells Persist at a Level the Same or Greater as the Level After the Final T Cell Infusion and Subsequent Booster Immunizations as Assessed by IFN-gamma (IFN-g) ELISPOT||Up to 2 year following the last infusion|||Participants|||Count of Participants
780881|NCT00791258|Secondary|Percentage of Participants Previously on an Angiotensin Converting Enzyme Inhibitor Achieving the Blood Pressure Goals From Baseline to 12 Weeks||Baseline to 12 weeks|Participants previously on an angiotensin converting enzyme inhibitor who have received at least one dose of study medication and who have a baseline value.||Percentage of participants|||Number
780862|NCT00791037|Primary|Evaluate Toxicity of Infusing HER2-specific T Cells as Assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0|Patients are monitored for the development of end organ damage by assessing adverse events with serum chemistries, liver function studies, complete blood counts, urine analysis and physical exams. All adverse events for all systems are graded on a scale of 1-5 and attribution is assigned. There are DLT criteria. DLT is defined as any incidence of Grade 3 hematologic and non-hematologic toxicity (excluding: fever, hypoxia, and urticaria) Thus, if a subject develops a Grade 3 toxicity (excluding those listed in Table 4) will be considered excessive toxicity and no further dose escalations will occur.|Up to 4 months after first booster vaccine|The infusion of escalating doses of HER2 specific T cells will be defined as safe if at least 75% of subjects are able to receive all 3 infusions without dose limiting toxicity (DLT)||participants|||Number
780863|NCT00791076|Secondary|Frequency of Hypoglycemia Defined as < 60 mg/dl.||72 hours|The PI left the institution and this study was terminated due to noncompliance with our Institutional Review Board. Data, if collected,is unknown since no data are available.|||||
780864|NCT00791076|Primary|Total Amount of Insulin Administered While on Placebo/PP.|Glucose values and the pattern of glycemic excursions over the 72 hour test period.|2 years|Data was not collected for this outcome measure. The P.I. left the institution and the study was terminated.|||||
780865|NCT00791089|Primary|Number of Participants With Normal Sinus Rhythm (Freedom From Atrial Arrhythmias)|Freedom from atrial arrhythmias at 6 months will be defined as absence of any atrial arrhythmias with or without antiarrhythmic drug (AAD) therapy as shown in the two lines|6 months|||Participants|||Count of Participants
780866|NCT00791102|Secondary|Change in Nasal Peak Inspiratory Flow Measurements From Before to After Treatment||15 minutes prior to treatment and 15 minutes post antigen challenges|||L/min||Inter-Quartile Range|Median
780867|NCT00791102|Primary|Change in Itching Symptom|The nasal symptoms on a scale of 0-3 (0=no symptoms, 1=mild, 2= moderate, 3= severe). The change is calculated by adding the score of itchy nose following both antigen challenges minus twice the score of itchy nose after the diluent challenge.|10 minutes after diluent challenge and 10 minutes after each antigen challenge|||units on a scale||Inter-Quartile Range|Median
780868|NCT00791102|Primary|Change in Stuffy Nose Symptom|The nasal symptoms on a scale of 0-3 (0=no symptoms, 1=mild, 2= moderate, 3= severe). The change is calculated by adding the score of stuffy nose following both antigen challenges minus twice the score of stuffy nose after the diluent challenge.|10 minutes after diluent challenge and 10 minutes after each antigen challenge|||units on a scale||Inter-Quartile Range|Median
780869|NCT00791102|Primary|Change in Runny Nose Symptom|The nasal symptoms on a scale of 0-3 (0=no symptoms, 1=mild, 2= moderate, 3= severe). The change is calculated by adding the score of runny nose following both antigen challenges minus twice the score of runny nose after the diluent challenge.|10 minutes after diluent challenge and 10 minutes after each antigen challenge|||units on a scale||Inter-Quartile Range|Median
780870|NCT00791102|Secondary|Nasal Peak Inspiratory Flow Measurements|The value of nasal peak inspiratory flow. The change is calculated by adding the values of nasal peak inspiratory flow following both antigen challenges minus twice the value of nasal peak inspiratory flow after the diluent challenge.|15 minutes after diluent challenge and 15 minutes after each antigen challenge|||L/min||Inter-Quartile Range|Median
780871|NCT00791102|Primary|Change in Sneezing Symptom|Sneezes. The change is calculated by adding the number of sneezes following both antigen challenges minus twice the number of sneezes after the diluent challenge.|10 minutes after diluent challenge and 10 minutes after each antigen challenge|||sneezes||Inter-Quartile Range|Median
780872|NCT00791128|Secondary|HbA1c Values at 12 Months||12 months|||HbA1c (%)||Standard Deviation|Mean
780873|NCT00791128|Primary|% of Excess Weight Loss (EWL)|"Percent excess weight loss (EWL) was calculated using Body Mass Index (BMI25) method: BMI25=ideal weight in kg/(height in meters)2 Ideal weight in kg = 25 x (Height in meters2) Baseline Excess weight = total weight - ideal weight
% EWL = (baseline excess weight - weight loss) x 100"|12 months|||% excess weight loss||Standard Deviation|Mean
780874|NCT00791258|Secondary|Percentage of Participants Previously on a Nondihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks||Baseline to 20 weeks|Participants previously on a Nondihydropyridine Calcium Channel Blocker who have received at least one dose of study medication and who have a baseline value.||Percentage of participants|||Number
780875|NCT00791258|Secondary|Percentage of Participants Previously on a Nondihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks||Baseline to 12 weeks|Participants previously on a Nondihydropyridine Calcium Channel Blocker who have received at least one dose of study medication and who have a baseline value.||Percentage of participants|||Number
780876|NCT00791258|Secondary|Percentage of Participants Previously on a Beta Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks||Baseline to 20 weeks|Participants previously on an beta blocker who have received at least one dose of study medication and who have a baseline value.||Percentage of participants|||Number
780877|NCT00791258|Secondary|Percentage of Participants Previously on a Beta Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks||Baseline to 12 weeks|Participants previously on an beta blocker who have received at least one dose of study medication and who have a baseline value.||Percentage of participants|||Number
780878|NCT00791258|Secondary|Percentage of Participants Previously on an Angiotensin II Receptor Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks||Baseline to 20 weeks|Participants previously on an angiotensin II receptor blocker who have received at least one dose of study medication and who have a baseline value.||Percentage of participants|||Number
780879|NCT00791258|Secondary|Percentage of Participants Previously on an Angiotensin II Receptor Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks||Baseline to 12 weeks|Participants previously on an angiotensin II receptor blocker who have received at least one dose of study medication and who have a baseline value.||Percentage of participants|||Number
780880|NCT00791258|Secondary|Percentage of Participants Previously on an Angiotensin Converting Enzyme Inhibitor Achieving the Blood Pressure Goals From Baseline to 20 Weeks||Baseline to 20 weeks|Participants previously on an angiotensin converting enzyme inhibitor who have received at least one dose of study medication and who have a baseline value.||Percentage of participants|||Number
780884|NCT00791258|Secondary|Percentage of Participants Previously on a Dihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks||Baseline to 20 weeks|Participants previously on a Dihydropyridine Calcium Channel Blocker who have received at least one dose of study medication and who have a baseline value.||Percentage of participants|||Number
780885|NCT00791258|Secondary|Percentage of Participants Previously on a Dihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks||Baseline to 12 weeks|Participants previously on a Dihydropyridine Calcium Channel Blocker who have received at least one dose of study medication and who have a baseline value.||Percentage of participants|||Number
780886|NCT00791258|Secondary|Percentage of Patients With Metabolic Syndrome Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|Subjects with metabolic syndrome (MS) who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. The number may vary due to missing data and the number of dropouts. MS is defined using waist size,and triglyceride, cholesterol, blood pressure, and body mass index values.||Percentage of Participants|||Number
780887|NCT00791258|Secondary|Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|Subjects with metabolic syndrome (MS) who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. The number may vary due to missing data and the number of dropouts. MS is defined using waist size,and triglyceride, cholesterol, blood pressure, and body mass index values.||Percentage of Participants|||Number
780888|NCT00791258|Secondary|Percentage of Patients With Metabolic Syndrome Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|Subjects with metabolic syndrome (MS) who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. The number may vary due to missing data and the number of dropouts. MS is defined using waist size,and triglyceride, cholesterol, blood pressure, and body mass index values.||Percentage of Participants|||Number
780889|NCT00791258|Secondary|Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|Subjects with metabolic syndrome (MS) who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. The number may vary due to missing data and the number of dropouts. MS is defined using waist size,and triglyceride, cholesterol, blood pressure, and body mass index values.||Percentage of Participants|||Number
780890|NCT00791258|Secondary|Percentage of Obese Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those obese participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts. Obesity is defined as Body Mass Index ≥30 kg/m2||Percentage of Participants|||Number
780891|NCT00791258|Secondary|Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those obese participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts. Obesity is defined as Body Mass Index ≥30 kg/m2.||Percentage of Participants|||Number
780892|NCT00791258|Secondary|Percentage of Obese Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those obese participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts. Obesity is defined as Body Mass Index ≥30 kg/m2||Percentage of Participants|||Number
780893|NCT00791258|Secondary|Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those obese participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts. Obesity is defined as Body Mass Index ≥30 kg/m2||Percentage of Participants|||Number
780894|NCT00791258|Secondary|Percentage of Type 2 Diabetic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those type 2 diabetic participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.||Percentage of Participants|||Number
780895|NCT00791258|Secondary|Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those type 2 diabetic participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts.||Percentage of Participants|||Number
780896|NCT00791258|Secondary|Percentage of Type 2 Diabetic Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those type 2 diabetic participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts.||Percentage of Participants|||Number
780897|NCT00791258|Secondary|Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those type 2 diabetic participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts.||Percentage of Participants|||Number
780898|NCT00791258|Secondary|Percentage of Elderly Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those elderly participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts. Elderly is defined as greater than or = to 65 years of age.||Percentage of Participants|||Number
780899|NCT00791258|Secondary|Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those elderly participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts. Elderly is defined as greater than or = to 65 years of age.||Percentage of Participants|||Number
780900|NCT00791258|Secondary|Percentage of Elderly Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those elderly participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts. Elderly is defined as greater than or = to 65 years of age.||Percentage of Participants|||Number
780901|NCT00791258|Secondary|Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those elderly participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts. Elderly is defined as greater than or = to 65 years of age.||Percentage of Participants|||Number
780902|NCT00791258|Secondary|Percentage of Hispanic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those Hispanic participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.||Percentage of Participants|||Number
780903|NCT00791258|Secondary|Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those Hispanic participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.||Percentage of Participants|||Number
780904|NCT00791258|Secondary|Percentage of Hispanic Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those Hispanic participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.||Percentage of Participants|||Number
780905|NCT00791258|Secondary|Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those Hispanic participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts.||Percentage of Participants|||Number
780906|NCT00791258|Secondary|Percentage of Asian Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those Asian participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.||Percentage of Participants|||Number
780907|NCT00791258|Secondary|Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those Asian participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.||Percentage of Participants|||Number
780908|NCT00791258|Secondary|Percentage of Asain Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those Asian participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.||Percentage of Participants|||Number
780909|NCT00791258|Secondary|Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those Asian participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts.||Percentage of Participants|||Number
780910|NCT00791258|Secondary|Percentage of African American/Black Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.||Percentage of Participants|||Number
780911|NCT00791258|Secondary|Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.||Percentage of Participants|||Number
780912|NCT00791258|Secondary|Percentage of African American/Black Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those African American/Black participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.||Percentage of Participants|||Number
780913|NCT00791258|Secondary|Percentage of African American/Black Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those African American/Black participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.||Percentage of Participants|||Number
780914|NCT00791258|Secondary|Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those African American/Black participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.||Percentage of Participants|||Number
780915|NCT00791258|Secondary|Change From Baseline to Week 20 in Ambulatory Systolic and Diastolic Blood Pressure Values|Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Daytime is defined as 8 a.m. to 4 p.m. Nighttime is defined as 10 p.m. to 6 a.m.|Baseline to 20 weeks|Ambulatory blood pressure (ABPM) subset of participants who have both technically successful baseline and 20 week ABPM data.||mm Hg||Standard Error|Mean
780916|NCT00791258|Secondary|Change From Baseline to Week 12 in Ambulatory Systolic and Diastolic Blood Pressure Values|Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Daytime is defined as 8 a.m. to 4 p.m. Nighttime is defined as 10 p.m. to 6 a.m.|Baseline to 12 weeks|Ambulatory blood pressure (ABPM) subset of participants who have both technically successful baseline and 12 week ABPM data.||mm Hg||Standard Error|Mean
780917|NCT00791258|Secondary|Percentage of Participants Achieving the Mean 24-hour Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks|Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours.|Baseline to 20 weeks|Ambulatory blood pressure (ABPM) subset of participants who have both technically successful baseline and 20 week ABPM data.||Percentage of participants|||Number
780918|NCT00791258|Secondary|Percentage of Participants Achieving the Mean 24-hour Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks|Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours.|Baseline to 12 weeks|Ambulatory blood pressure (ABPM) subset of participants who have both technically successful baseline and 12 week ABPM data.||Percentage of participants|||Number
780919|NCT00791258|Secondary|Percentage of Participants Achieving the Mean Nighttime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks|Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Nighttime is defined as 10 p.m. - 6 a.m.|Baseline to 20 weeks|Ambulatory blood pressure (ABPM) subset of participants who have both technically successful baseline and 20 week ABPM data.||Percentage of participants|||Number
780920|NCT00791258|Secondary|Percentage of Participants Achieving the Mean Nighttime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks|Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Nighttime is defined as 10p.m. - 6 a.m.|Baseline to 12 weeks|Ambulatory blood pressure (ABPM) subset of participants who have both technically successful baseline and 12 week ABPM data.||Percentage of participants|||Number
780921|NCT00791258|Secondary|Percentage of Participants Achieving the Mean Daytime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks|Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Daytime is defined as 8AM - 4PM.|Baseline to 20 weeks|Ambulatory blood pressure (ABPM) subset of participants who have both technically successful baseline and 20 week ABPM data.||Percentage of participants|||Number
780922|NCT00791258|Secondary|Percentage of Participants Achieving the Mean Daytime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks|Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Daytime is defined as 8AM – 4PM.|Baseline to 12 weeks|Ambulatory blood pressure (ABPM) subset of participants who have both technically successful baseline and 12 week ABPM data.||Percentage of participants|||Number
780923|NCT00791258|Secondary|Percentage of Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.||Percentage of Participants|||Number
780924|NCT00791258|Secondary|Percentage of Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.||Percentage of Participants|||Number
780925|NCT00791258|Secondary|Percentage of Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.||Percentage of Participants|||Number
780926|NCT00791258|Secondary|Percentage of Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.||Percentage of Participants|||Number
780927|NCT00791258|Secondary|Percentage of Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.||Percentage of participants|||Number
780928|NCT00791258|Secondary|Change in Mean Seated Diastolic Blood Pressure From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.||mm Hg||Standard Error|Mean
780929|NCT00791258|Secondary|Change in Mean Seated Systolic Blood Pressure From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those participants who have a baseline and at lease 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.||mm Hg||Standard Error|Mean
780930|NCT00791258|Secondary|The Percentage of Subjects Who Achieve BP Goal (<140/90 mmHg for Non-diabetics or <130/80 mmHg for Diabetics) From Baseline to 12 and 20 Weeks||Baseline to 12 and 20 weeks|The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication.||Percentage of participants|||Number
780931|NCT00791258|Secondary|The Percentage of Subjects Achieving Seated Diastolic BP Goal (<90 mmHg for Non-diabetics or < 80 mmHg for Subjects With Diabetes) From Baseline to 12 Weeks||baseline to 12 weeks|The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication.||Percentage of participants|||Number
780932|NCT00791258|Primary|The Percentage of Patients Who Achieve Seated Systolic Blood Pressure Goal (<140 mm Hg for Non-diabetics and <130 mm Hg for Diabetics) From Baseline to 12 Weeks||baseline to 12 weeks|The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication.||Percentage of participants|||Number
780933|NCT00791323|Primary|Mean Prostaglandin E2 (PGE2) Aqueous Humor Levels|The mean level of PGE2 (a naturally occurring prostaglandin E2 in the eye that can cause inflammation and other complications) in the aqueous humor (the thin, watery fluid in the eye) 2 days following peripheral iridotomy (ocular surgery).|Day 3|Intent to Treat defined as all patients who started the study (randomized) with processed aqueous samples. Two patients in the Ketorolac 0.4% arm did not have aqueous humor samples processed.||Picograms per milliliter (pg/ml)||Standard Deviation|Mean
780934|NCT00791336|Secondary|Safety and Tolerability of the Combined Treatment Regimen||7 weeks|Only 1 subject was enrolled and treated. Study was terminated due to poor enrollment. Data were not collected or analyzed due to study termination and low enrollment count (n=1).|||||
780935|NCT00791336|Secondary|Characterization of Overall and Disease-free Survival||long-term|Only 1 subject was enrolled and treated. Study was terminated due to poor enrollment. Data were not collected or analyzed due to study termination and low enrollment count (n=1).|||||
780936|NCT00791336|Primary|Pathologic Complete Response||30 days|Only 1 subject was enrolled and treated. Study was terminated due to poor enrollment. Data were not collected or analyzed due to study termination and low enrollment count (n=1).|||||
780937|NCT00791388|Primary|t½,z Over a Dosing Interval (τ = 12 Hours)on Day 14|t½,z is the terminal exponential half-life; over a Dosing Interval (τ = 12 Hours)on Day 14|over a Dosing Interval (τ = 12 Hours) on Day 14|||hours||Standard Deviation|Mean
780938|NCT00791388|Primary|Tmax Over a Dosing Interval (τ = 12 Hours) on Day 14|the time at which maximum plasma concentration occurred (Tmax) Over a Dosing Interval (τ = 12 Hours) on Day 14|12 Hours on Day 14|||hours||Standard Deviation|Mean
780939|NCT00791388|Primary|Cmax Over a Dosing Interval (τ = 12 Hours)on Day 14|Maximum plasma concentration (Cmax) over a dosing interval (τ = 12 hours)on Day 14|12 hours on Day 14|||ng/mL||Standard Deviation|Mean
780940|NCT00791388|Primary|AUCτ Over a Dosing Interval (τ = 12 Hours) on Day 14|the area under the plasma concentration-time curve over a dosing interval (τ = 12 hours) on Day 14 of Multiple Dose Oral Administration of PG-760564 Given Every 12 Hours|14 days|PG 760564 blood plasma concentrations were not measured for the placebo arm||ng*h/mL||Standard Deviation|Mean
780941|NCT00804193|Secondary|Proportion of Subjects With Clinical Cure|Clinical Cure was defined as a signs and symptoms score of <1 for erythema; <1 for scaling; and 0 for pruritus, maceration, fissuring/cracking, and burning/stinging; as well as an assessment that no additional antifungal therapy was required to treat the subject’s current episode of tinea pedis|6 weeks|||participants|||Number
780942|NCT00804193|Secondary|Proportion of Subjects With Mycological Cure|Potassium hydroxide [KOH] wet mount negative and fungal culture negative|6 weeks|||participants|||Number
780943|NCT00804193|Primary|Proportion of Subjects in Each Treatment Group With Therapeutic Success|Therapeutic success was defined as having both Mycological Cure (potassium hydroxide [KOH] wet mount negative and fungal culture negative) and Clinical Cure|6 weeks|Per protocol population||participants|||Number
780944|NCT00808132|Secondary|Percentage of Participants With Uterine Bleeding|Percentage of participants with uterine bleeding were calculated for each 4-week period for 1-year on therapy.|Week 1-4, 5-8, 9-12, 13-16, 17-20, 21-24, 25-28, 29-32, 33-36, 37-40, 41-44, 45-48, 49-52|MITT population included all randomized participants who took at least 1 dose of the study drug, and had at least 1 day of on-therapy bleeding data. Here “N” signifies participants who were evaluable for this outcome measure and “n” signifies participants who were evaluable at specified time points for each arm respectively.||Percentage of Participants|||Number
781469|NCT00795145|Secondary|Cohort 2: Mean Time-Matched Difference in Uncorrected QT Intervals Between Linezolid 600 mg and 1200 mg Compared to Placebo|A measure of dispersion is not available.|0.5, 1, 2, 4, 8, 12, 24 hours post-dose|PK parameter analysis population||msec|||Number
780945|NCT00808132|Secondary|Change From Baseline in Menopause-Specific Quality of Life (MENQOL) Score at Month 3: Sleep Sub-Study|MENQOL questionnaire assessed how bothered participants were due to menopause. It consists of 29 items divided into 4 domains: vasomotor function (3 items), psychosocial function (7 items), physical function (16 items), and sexual function (3 items). Each item scores a range from 1 to 8, with 1 indicating that the participant did not experience the symptom or problem, 8 indicating that the participant was extremely bothered by the symptom or problem. The total score for each domain is the average of item scores and ranged from 1 to 8 with higher score indicating worsening of symptoms. The MENQOL total score is the mean of these 4 domain scores and ranged from 1 to 8 with higher score indicating worsening of symptoms.|Baseline, Month 3|"MITT population included all randomized participants who met inclusion criteria for sleep sub-study and had baseline and at least 1 post-baseline evaluation for the respective endpoint. Here N: maximum number of participants who were evaluable for this outcome and n: participants who were evaluable at specified time points for each arm."||Units on a Scale||Standard Error|Least Squares Mean
780946|NCT00808132|Secondary|Menopause-Specific Quality of Life (MENQOL) Score at Baseline: Sleep Sub-Study|MENQOL questionnaire assessed how bothered participants were due to menopause. It consists of 29 items divided into 4 domains: vasomotor function (3 items), psychosocial function (7 items), physical function (16 items), and sexual function (3 items). Each item scores a range from 1 to 8, with 1 indicating that the participant did not experience the symptom or problem, 8 indicating that the participant was extremely bothered by the symptom or problem. The total score for each domain is the average of item scores and ranged from 1 to 8 with higher score indicating worsening of symptoms. The MENQOL total score is the mean of these 4 domain scores and ranged from 1 to 8 with higher score indicating worsening of symptoms.|Baseline|MITT population included all randomized participants who met inclusion criteria for sleep sub-study and had baseline and at least 1 post-baseline evaluation for the respective endpoint. Here N = maximum number of participants who were evaluable for this outcome and n = participants who were evaluable at specified time points for each arm.||Units on a Scale||Standard Deviation|Mean
780947|NCT00808132|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Month 3: Sleep Sub-Study|Participant-rated questionnaire to assess sleep quality and quantity. Consists of 12-item questionnaires answered on a range of 1 to 6 for questions (Q) 3 to 12, 1 to 5 for Q1 (some questions are reversed so that a high score reflects more of the attributes); and Q2 answered on 0 to 24. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute. The items contribute to each scale and are averaged to create the 7 scale scores and a sleep quantity scale. Scales with at least one item answered was used to generate a scale score. Scales include; sleep disturbance (SD), snoring, awaken short of breath (ASoB) or with a headache (H), somnolence, sleep adequacy (SA), sleep problem index (SPI) I and II (range: 0-100) and sleep quantity (SQ [range 0 to 24]). Except for sleep quantity, higher scores=greater impairment.|Baseline, Month 3|MITT population included all randomized participants who met inclusion criteria for sleep sub-study and had baseline and at least 1 post-baseline evaluation for the respective endpoint. Here N = maximum number of participants who were evaluable for this outcome and n = participants who were evaluable at specified time points for each arm.||Units on a Scale||Standard Error|Least Squares Mean
780948|NCT00808132|Other Pre-specified|Percentage of Participants With Breast Tenderness|Percentage of participants who reported at least 1 day of breast tenderness during each 4-week period for 1-year on therapy was calculated.|Screening, Week 1-4, 5-8, 9-12, 13-16, 17-20, 21-24, 25-28, 29-32, 33-36, 37-40, 41-44, 45-48, 49-52|MITT population included all randomized participants who took 1 dose of study drug and had at least 20 days of data available at screening and at least 20 continuous days of data in at least one 4-week interval after baseline.||Percentage of Participants|||Number
780949|NCT00808132|Secondary|Medical Outcomes Study (MOS) Sleep Scale at Baseline: Sleep Sub-Study|Participant-rated questionnaire to assess sleep quality and quantity. Consists of 12-item questionnaires answered on a range of 1 to 6 for questions (Q) 3 to 12, 1 to 5 for Q1 (some questions are reversed so that a high score reflects more of the attributes); and Q2 answered on 0 to 24. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute. The items contribute to each scale and are averaged to create the 7 scale scores and a sleep quantity scale. Scales with at least one item answered was used to generate a scale score. Scales include; sleep disturbance (SD), snoring, awaken short of breath (ASoB) or with a headache (H), somnolence, sleep adequacy (SA), sleep problem index (SPI) I and II (range: 0-100) and sleep quantity (SQ [range 0 to 24]). Except for sleep quantity, higher scores=greater impairment.|Baseline|MITT population included all randomized participants who met inclusion criteria for sleep sub-study and had baseline and at least 1 post-baseline evaluation for the respective endpoint. Here N = maximum number of participants who were evaluable for this outcome and n = participants who were evaluable at specified time points for each arm.||Units on a Scale||Standard Deviation|Mean
780950|NCT00808132|Secondary|Percent Change From Baseline in Bone Turnover Markers (BTMs) at Month 6 and Month 12: Osteoporosis Sub-Study|Bone turnover is the removal of old bone from the body and its replacement by new bone. Bone turnover markers included serum osteocalcin, C-telopeptide, and procollagen type 1 N-propeptide (P1NP), were measured at Month 6 and Month 12 for a subset of participants who entered the osteoporosis substudy. Blood samples were collected to evaluate bone turnover markers levels.|Baseline, Month 6, 12|"MITT for osteoporosis substudy. Here N signifies participants who were evaluable for this outcome measure and n signifies participants who were evaluable at specified time points for each arm respectively."||Percent Change||Inter-Quartile Range|Median
780951|NCT00808132|Secondary|Percent Change From Baseline in Breast Density at Month 12: Breast Density Sub-Study|Breast density was assessed by digitalized mammograms which were centrally read by a single radiologist using specifically-developed software. Breast density was assessed for subset of participants who entered the breast density sub-study|Baseline, Month 12|"Per-Protocol (PP) population included all randomized participants who met inclusion criteria for breast density sub-study, who had a baseline and at least 1 post-baseline breast density evaluation and did not have substantial protocol violations. Here N signifies participants who were evaluable for this outcome measure."||Percent Change||Standard Error|Least Squares Mean
781470|NCT00795145|Secondary|Cohort 2: Mean Time-Matched Difference in QTcF Intervals Between Moxifloxacin and Placebo|A measure of dispersion is not available.|0.5, 1, 2, 4, 8, 12, 24 hours post-dose|PK parameter analysis population||msec|||Number
780952|NCT00808132|Secondary|Percentage of Participants With Cumulative Amenorrhea: Main Study|Cumulative amenorrhea was defined as the absence of any bleeding or spotting for cumulative 4-week periods throughout 1-year study.|Day 1 up to Day 364|MITT population included all randomized participants who received at least 1 dose of the study drug, and had at least 1 day of on-therapy bleeding data. Here “N” signifies participants who were evaluable for this outcome measure.||Percentage of Participants|||Number
780953|NCT00808132|Secondary|Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at Month 6, 12: Osteoporosis Sub-Study|BMD measurements of the total hip were acquired by using DXA scans, twice at Month 6 and 12 for a subset of participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. Mean percentage change from baseline of the 2 readings were reported.|Baseline, Month 6, Month 12|"MITT for osteoporosis sub-study. LOCF method was used to impute missing values. Here n signifies participants who were evaluable at specified time points for each arm, respectively."||Percent Change||Standard Error|Least Squares Mean
780954|NCT00808132|Secondary|Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 6: Osteoporosis Sub-Study|BMD measurements of the anteroposterior lumbar spine were acquired by using DXA scans, twice at Month 6 for a subset of participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. Mean percentage change from baseline of the 2 readings were reported.|Baseline, Month 6|"MITT population included all randomized participants who met inclusion criteria for osteoporosis sub-study, who had taken at least 1 dose of the study drug, and had baseline and at least 1 post baseline value. LOCF method was used to impute missing values. Here N signifies participants who were evaluable for this outcome measure."||Percent Change||Standard Error|Least Squares Mean
780955|NCT00808132|Primary|Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 12: Osteoporosis Sub-Study|BMD measurements of the anteroposterior lumbar spine were acquired by using dual-energy x-ray absorptiometry (DXA) scans, twice at Month 12 for a subset of participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. Mean percentage change from baseline of the 2 readings were reported.|Baseline, Month 12|Modified Intent-to-Treat (MITT) population included all randomized participants who met inclusion criteria for osteoporosis sub-study, who had taken at least 1 dose of the study drug, and had a baseline and at least 1 post baseline value. Last Observation Carried Forward (LOCF) method was used to impute missing values.||Percent Change||Standard Error|Least Squares Mean
780956|NCT00808132|Primary|Percentage of Participants With Endometrial Hyperplasia at Month 12: Main Study|Endometrial hyperplasia was assessed by endometrial biopsies. All endometrial biopsies were read centrally by 2 primary pathologists. If both the pathologists disagreed on the presence of hyperplasia, a third pathologist was consulted. Results were summarized for two definitions of hyperplasia (simple hyperplasia with or without atypia or complex hyperplasia with or without atypia); definition 1: participants were considered to have a diagnosis of hyperplasia when the 3 pathologists disagreed but at least 1 pathologist determined hyperplasia; definition 2: participants were considered to have a diagnosis of hyperplasia if at least 2 of the 3 pathologists agreed on the diagnosis.|Month 12|Efficacy evaluable (EE) population included all randomized participants who took at least 1 dose of study drug, who had a screening endometrial biopsy with readings by at least 2 blinded central pathologists, had a biopsy during Month 12, or had hyperplasia diagnosed before Month 12 and had no major protocol violations.||Percentage of Participants||95% Confidence Interval|Number
780957|NCT00808236|Post-Hoc|Outcomes for Patients Receiving EMS CPR Within 10 Minutes of Collapse That Were Admitted to the Hospital||Hospital Discharge|Subset of patients that received EMS CPR within 10 minutes of collapse, achieved ROSC, and were subsequently admitted to the hospital.||participants|||Number
780958|NCT00808236|Post-Hoc|Outcomes for VF Patients Admitted to the Hospital|Survival and neurologically-intact survival for patients found in VF/VT admitted to the hospital|Hospital discharge|Subset of patients with an initial rhythm of VF/VT, achieved ROSC and were subsequently admitted to the hospital||participants|||Number
780959|NCT00808236|Post-Hoc|Outcomes for Patients Admitted to the Hospital|Suvival and neurologically intact survival|Hospital discharge|Subset of patients that achieved ROSC and were subsequently admitted to the hospital.||participants|||Number
780960|NCT00808236|Secondary|24-hour Adverse Events (AE)|These were all non-serious adverse events that occurred between the time of enrollment and 24 hours after resuscitation. These did not include a failure to achieve ROSC.|24 hours after arrest|all enrolled participants||all participants|||Number
780961|NCT00808236|Secondary|Serious Adverse Events (SAEs)|These were defined serious adverse events that are not direct sequelae of the cardiac arrest itself or the underlying cardiac disease. Therefore, these do not include recurrent arrests occcuring within 24 hours of resuscitation nor deaths due to lack of cardiac and/or neurological recovery.|7 days after arrest|"All enrolled patients; see additional modified at risk population based on study attrition in the Adverse Event section."||all participants|||Number
780962|NCT00808236|Post-Hoc|Primary Outcomes in Sub-group Receiving EMS CPR Within 10 Minutes of Collapse|ROSC, Survival, and neurologically-intact survival|Hospital discharge|Subset of patients receiving EMS CPR within 10 minutes of collapse (representing 75% of all patients)||participants|||Number
780963|NCT00808236|Secondary|Length of Stay|"Length of stay data for patients admitted to the hospital will be calculated for:
Days on ventilator
Days in intensive care without ventilator
Days in general ward"|Hospital Discharge|Evaluable patients admitted to the hospital||days||Inter-Quartile Range|Median
780964|NCT00808236|Secondary|Time to Therapeutic Temperature|The therapeutic temperature range for treatment in cardiac arrest is considered to be 32-34C. Time to therapeutic temperature was taken as the first time in which 34C was measured. Tympanic and core temperatures were taken in all patients.|within 8 hours after enrollment|The subset of patients that were resuscitated and subsequently received in-hospital cooling and reached the designated therapuetic temperatures.||minutes||Inter-Quartile Range|Median
780965|NCT00808236|Secondary|Primary Outcomes in Sub-group With VF/VT as First Rhythm|ROSC, survival, and neurologically-intact survival|hospital discharge|Subset of all included patients with VF/VT as the first cardiac rhythm present upon ECG assessment by EMS personnel||participants|||Number
780966|NCT00808236|Primary|Survived Neurologically-Intact|"The Cerebral Performance Categories (CPC) are used to describe neurological outcome. A CPC of 1 or 2 is considered neurologically intact.
- Good cerebral performance: little to no deficit.
- Moderate cerebral disability: capable of independent activities of daily life
- Severe cerebral disability: conscious, but dependent on others for daily support
- Coma or vegetative state
- Death or brain death"|30-days after arrest|The set of patients excluding those not meeting IC/EC, not lost to follow-up, or not crossed-over/withdrawn.||participants|||Number
780967|NCT00808236|Primary|Survived to Hospital Discharge|The study end-point was hospital discharge. This outcome measure is the patient count for those that were discharged alive from the hospital.|30 days after arrest|"The set of patients excluding those not meeting IC/EC, not lost to follow-up, or not crossed-over/withdrawn. One RhinoChill patient that achieved ROSC was found to be DNAR upon hospital arrival and was excluded from analyses thereafter. The final number of analyzed RhinoChill patients was therefore 82."||participants|||Number
780968|NCT00808236|Primary|Achieve Return of Spontaneous Circulation (ROSC)|ROSC was defined as the return of an organized rhythm on electrocardiography (ECG) with a palpable pulse that was maintained for at least 20 minutes.|1-hour after arrest|Only patients meeting all inclusion/exclusion criteria (IC/EC) were included in the analyses. 15 patients were found to not meet all IC/EC after enrollment. 2 more patients were lost to follow-up and 1 patient was crossed over (Control to RhinoChill) and then withdrawn. Informed consent nor data was obtained for any of these patients.||participants|||Number
780969|NCT00808249|Secondary|Change in Sheehan Disability Scale (SDS) Global Total Score|The Sheehan Disability Scale is a patient-rated measure of functional disability in 3 subscales: work, social, and family life. Each subscale is rated from 0 to 10, with 0 as the best. SDS global total score is calculated as the sum of 3 subscales and ranges from 0(unimpaired) to 30 (highly impaired)|From baseline ( randomization) to week 4|||Units on scale||Standard Error|Least Squares Mean
780970|NCT00808249|Secondary|Change in Somatic Symptoms as Measured by HAM-A Somatic Factor Score|The HAM-A somatic factor score is calculated as the sum of 7 individual HAM-A items (each is rated from 0 to 4, 0 is the best) related with somatic anxiety symptoms. The minimum score for HAM-A somatic factor is 0 and maximum score is 28, higher score indicates severe somatic anxiety symptoms|From baseline ( randomization) to week 4|||Units on scale||Standard Error|Least Squares Mean
780971|NCT00808249|Secondary|Change in Psychic Anxiety Symptoms as Measured by HAM-A Psychic Anxiety Factor Score|The HAM-A psychic anxiety factor score is calculated as the sum of 7 HAM-A individual items related with psychic anxiety ( each rated from 0 to 4, 0 is the best). The minimum score for HAM-A psychic anxiety factor is 0 and maximum score is 28, higher score indicates severe psychic anxiety symptoms.|From baseline (randomization) to week 4|||Unit on scale||Standard Error|Least Squares Mean
780972|NCT00808249|Secondary|Change in Hospital Anxiety and Depression Scale for Anxiety (HADS-A) Total Score|The HADS-A is a 7 item, self administered instrument to measure level of anxiety. Each item is a score rate from 0 (happens rarely ) to 3 (happens frequently), and the items are totaled for a maximum score of 21. The mimimum score 0 indicates that the patient rarely suffered from anxiety symptoms.|From randomization (baseline) to week 4|||Units on scale||Standard Error|Least Squares Mean
780973|NCT00808249|Primary|Change From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score|The HAM -A is a 14-item clinician administered scale for the evaluation of anxiety symptoms. Each HAM-A item is rated on a 0 (not present) to 4 (very severe) scale, higher score indicates high level of anxiety. The HAM-A total score is calculated as the sum of 14 individual scores, with 56 as the maximum.|From randomization (baseline) to week 4|||Units on scale||Standard Error|Least Squares Mean
780974|NCT00808340|Primary|Overall Subjective Vision|Subject rated the overall quality of vision with the study contact lenses. 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.|after 1 week of lens wear, for each lens type|||Units on a scale||Standard Error|Least Squares Mean
780975|NCT00808340|Primary|Type of Corneal Staining|Investigator rated type of corneal staining as either 0=none, 1=micropunctate, 2=macropunctate, 3=coalesced, or 4=patch(> or = to mm).|after 1 week of lens wear, for each lens type|||Units on a scale||Standard Error|Least Squares Mean
780976|NCT00808340|Primary|Near Bright Illumination Binocular Visual Performance Reported as Visual Acuity|Tested with both eyes together in bright lighting reading charts near to the subject. This outcome is measured in logMAR units.LogMAR stands for the logarithm of the minimum angle of resolution. Ideal is 0.0 and represents 20/20 Snellen acuity. logMAR values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.|5 minutes after insertion|||logMAR||Standard Error|Least Squares Mean
780977|NCT00808340|Primary|Distance Bright Illumination Binocular Visual Performance Reported as Visual Acuity|Tested with both eyes together in bright lighting, reading charts distant to the subject. This outcome is measured in logMAR units.LogMAR stands for the logarithm of the minimum angle of resolution. Ideal is 0.0 and represents 20/20 Snellen acuity. logMAR values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.|5 minutes after insertion|||logMAR||Standard Error|Least Squares Mean
780980|NCT00808444|Secondary|Occurrence of Unsolicited Adverse Events|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Within 31 days (day 0-30) after vaccination|Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.||subjects|||Number
781487|NCT00795366|Primary|Time ICP >20|The number of hours that participants remained with intracranial pressure above 20 mmHg|The number of hours during the first 5 days of intracranial pressure monitoring|Intent-to-Treat||Hours||Standard Deviation|Mean
780981|NCT00808444|Secondary|Concentration of Antibody Against Polyribosyl-ribitol Phosphate (PRP)|Concentrain was expressed as GMC in µg/mL.|One month after primary immunization (month 4)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.||µg/mL||95% Confidence Interval|Geometric Mean
780982|NCT00808444|Secondary|Concentrations of Antibodies Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), Pertactin (PRN)|Concentrations are expressed as GMCs in EL.U/mL.|One month after primary immunization (month 4)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.||EL.U/mL||95% Confidence Interval|Least Squares Mean
780983|NCT00808444|Secondary|Number of Subjects With Solicited Local and General Symptoms.|"Solicited local symptoms were pain, redness and swelling.
Solicited general symptoms were drowsiness, fever, irritability, loss of appetite, diarrhoea and vomiting."|Within 4 days (day 0-3) after vaccination|Analysis was performed on the Total Vaccinated Cohort, which inlcuded all vaccinated subjects.||subjects|||Number
780984|NCT00808444|Secondary|Opsonophagocytic Titers of Vaccine Pneumococcal Serotypes|"Titers are presented as Geometric Mean Titers (GMTs).
Pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F."|One month after primary immunization (month 4)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.||titer||95% Confidence Interval|Geometric Mean
780985|NCT00808444|Secondary|Occurrence of Serious Adverse Events|SAEs assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Following vaccination and throughout the entire study period (Month 0 to Month 4)|Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.||subjects|||Number
780986|NCT00808444|Secondary|Concentration of Antibody Against Rotavirus Immunoglobulin A (IgA)|Concentration was expressed as GMC in units per milliliter (U/mL).|3 months after primary immunization (month 4)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.||U/mL||95% Confidence Interval|Geometric Mean
780987|NCT00808444|Secondary|Concentration of Antibody Against Hepatitis B Surface Antigen (HBs)|Concentration was given as GMC in milli international units per milliliter (mIU/mL).|One month after primary immunization (month 4)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.||mIU/mL||95% Confidence Interval|Geometric Mean
780988|NCT00808444|Secondary|Concentrations of Antibodies Against Diphteria Toxoid (DT) and Tetanus Toxoid (TT)|Concentrations were defined as GMCs in international units per milliter (IU/mL)|One month after primary immunization (month 4)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.||IU/mL||95% Confidence Interval|Geometric Mean
780989|NCT00808444|Secondary|Poliovirus Types 1, 2 and 3 Titers|Titers were given as Geometric Mean Titers (GMTs).|One month after primary immunization (month 4)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.||titer||95% Confidence Interval|Geometric Mean
780990|NCT00808444|Secondary|Opsonophagocytic Titers of Cross-reactive Pneumococcal Serotypes|"Opsonophagocytic titers were expressed as GMTs.
Cross-reactive pneumococcal serotypes included 6A and 19A."|One month after primary immunization (month 4)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.||titer||95% Confidence Interval|Geometric Mean
780991|NCT00808444|Secondary|Number of Subjects With Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes|"Cross-reactive pneumococcal serotypes were 6A and 19A.
Opsonophagocytic activity was defined as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay was an opsonic titer equal to or greater than 8."|One month after primary immunization (month 4)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.||subjects|||Number
780992|NCT00808444|Secondary|Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes|"Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.
Opsonophagocytic activity was defined as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay was an opsonic titer equal to or greater than 8."|One month after primary immunization (month 4)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.||subjects|||Number
780993|NCT00808444|Secondary|Number of Subjects With Anti-pneumococcal Cross-reactive Serotype Concentrations Equal to or Above 0.20 µg/mL|Anti-pneumococcal cross-reactive serotypes were 6A and 19A.|One month after primary immunization (month 4)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.||subjects|||Number
780994|NCT00808444|Secondary|Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 µg/mL|Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.|One month after primary immunization (month 4)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.||subjects|||Number
780995|NCT00808444|Primary|Concentration of Antibody Against Protein D (PD)|Concentration was expressed as GMC in GSK’s 22F enzyme-linked-immunosorbent assay (ELISA) units per milliliter (EL.U/mL).|One month after primary immunization (month 4)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
780996|NCT00808444|Primary|Concentrations of Antibodies Against Vaccine Components of the Pneumococcal Vaccine|"Concentrations are given as Geometric Mean Concentrations (GMCs) in microgram per milliliter (μg/mL).
Vaccine pneumococcal serotypes assessed included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F."|One month after primary immunization (month 4)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.||μg/mL||95% Confidence Interval|Geometric Mean
780997|NCT00808470|Other Pre-specified|Distortion Product Otoacoustic Emission (DPOAE) Amplitude - Additional Pairs|Distortion Product Otoacoustic Emission (DPOAE) Amplitude was measured following the audiometric testing completion at approximately 30 minutes post music. F1 and F2 frequency pairs included 6656 and 8015 Hz, 5016 and 6000 Hz, 2484 and 3000 Hz, and 1687 and 2015 Hz. F1 sound levels started at 65 dB SPL at each frequency, and decreased in 5 dB steps to a level of 25 dB SPL. F2 levels were 10dB lower than F1 Levels. Threshold tests began precisely at 15 min, 1 hr 15 min, 2 hr 15 min, 3 hr 15 min. The OAE testing began as soon as threshold testing completed. Threshold tests take approximately 15 min, but the exact duration of testing varies among subjects. Thus, OAE tests began approx. 30 min, 1 hr 30 min, 2 hr 30 min, and 3 hr 30 min post music, but for some it may have been a little bit earlier than for others (i.e., the test may have begun as early as 25 min or as late as 35 min post music, depending on how quickly the subject completed threshold testing).|15 minutes||||||
780998|NCT00808470|Other Pre-specified|Distortion Product Otoacoustic Emission (DPOAE) Amplitude - Additional Time Measures|DPOAE amplitude was measured following the audiometric testing completion at each of the post-music test times. F1 and F2 frequency pairs included 6656 and 8015 Hz, 5016 and 6000 Hz, 3328 and 3984 Hz, 2484 and 3000 Hz, and 1687 and 2015 Hz. F1 sound levels started at 65 dB SPL at each frequency, and decreased in 5 dB steps to a level of 25 dB SPL. F2 levels were 10 dB lower than F1 levels.|repeated measures at 1 hr intervals for 3 hours to measure temporary changes; additional tests at 1 day and 1 week post-exposure.||||||
780999|NCT00808470|Other Pre-specified|Threshold Shift at Individual Frequencies, Including 0.25, 0.5, 1, 2, 3, 6, 8, kHz||repeated measures at 1 hr intervals for 3 hours to measure temporary changes; additional tests at 1 day and 1 week post-exposure.||||||
781000|NCT00808470|Other Pre-specified|Distortion Product Otoacoustic Emission (DPOAE) Amplitude - f1+3328 HZ, F2+ 3984 Hz; 30 Minutes|DPOAE amplitude was measured following the audiometric testing completion at approximately 30 minutes post music. Test time was approximate as DPOAE tests began as soon as threshold testing was completed. F1 and F2 frequency pairs included 3328 and 3984 Hz, F1 sound levels started at 65 dB SPL at each frequency, and decreased in 5 dB steps to a level of 25 dB SPL. F2 levels were 10 dB lower than F1 levels. Threshold tests began precisely at 15 min, 1 hr 15 min, 2 hr 15 min, 3 hr 15 min. Threshold tests take approximately 15 min, but the exact duration of testing varies from subject to subject. The OAE testing began as soon as threshold testing completed. Thus, OAE tests began approx. 30 min, 1 hr 30 min, 2 hr 30 min, and 3 hr 30 min post music, but for some it may have been a little bit earlier or a little bit later (i.e., the test may have begun as early as 25 min or as late as 35 min post music, depending on how quickly the subject completed threshold testing).|15 min|Data for one participant in the placebo group is incomplete.||decibels (dB)||Standard Deviation|Mean
781001|NCT00808470|Secondary|Tinnitus|Presence of tinnitus was assessed using yes/no question. If tinnitus was reported, perception was assessed using survey.|immediate, repeated measures at 1 hr intervals for 3 hours to measure temporary changes; additional tests at 1 day and 1 week post-exposure.|all participants completing music exposure completed tinnitus surveys.||participants|||Number
781002|NCT00808470|Secondary|Threshold Shift at Individual Frequencies, Including 0.25, 0.5, 1, 2, 3, 6, and 8 kHz, 15 Min Post-music|The study measures the quietest decibel level the participants can hear before the 4 hour music exposure The first post-music test to measure shift is 15 minutes after the music exposure is completed and again at 1 hour intervals. The shift represents the mean change in quietest decibel volume detected between baseline (pre-music) and post music.|15 min|all participants that completed music exposure were assessed; two participants withdrew prior to music exposure.||decibels||Standard Deviation|Mean
781003|NCT00808470|Primary|Average Threshold Shift at 4 kHz in Both Ears|The study measures the quietest decibel level the participants can hear before the 4 hour music exposure The first post-music test to measure shift is 15 minutes after the music exposure is completed and again at 1 hour intervals. The shift represents the mean change in quietest decibel volume detected between baseline (pre-music) and post music.|15 min, 1 hr intervals for 3 hours to measure temporary changes; additional tests at 1 day and 1 week post-exposure.|All subjects that completed music exposure were analyzed; two subjects withdrew from study prior to music exposure.||decibels||Standard Deviation|Mean
781004|NCT00808483|Secondary|Figure-of-eight Test|Test of dynamic balance. Number of steps on and outside the line is registered. 0 (best)|5 months and 12 months|||steps||95% Confidence Interval|Mean
781005|NCT00808483|Secondary|Index of Muscle Function (IMF)|Tests of general mobility, muscle strength, balance/coordination, and endurance. 40 (worse) - 0 (best)|5 months and 12 months|||units on a scale||95% Confidence Interval|Mean
781006|NCT00808483|Secondary|ROM Extension|Active range of motion (ROM) in hip extension test. Degrees is registered. 0 degrees indicates zero position of the hip, minus digrees indicates flexion contracture.|5 months and 12 months|||degrees||95% Confidence Interval|Mean
781007|NCT00808483|Secondary|Stair Climbing Test (ST)|Ascend and descend 8 steps with a step hight of 16 cm as fast as they could without running. Few seconds (best) - many seconds (worse)|5 months and 12 months|||seconds||95% Confidence Interval|Mean
781008|NCT00808483|Secondary|Self-efficacy|Self-reported self-efficacy in activities. 0 (worse) - 100 (best).|5 months and 12 months|||units on a scale||95% Confidence Interval|Mean
781009|NCT00808483|Secondary|Harris Hip Score (HHS)|Pain and physical function. 0 (worse) - 100 (best)|5 months and 12 months|||units on a scale||95% Confidence Interval|Mean
781010|NCT00808483|Secondary|Hip Dysfunction and Osteoarthritis Outcome Score (HOOS)|Self-reported symptoms, pain, physical function, function in sport and recreation, quality of life. 0 (worse) - 100 (best)|5 months and 12 months|||units on a scale||95% Confidence Interval|Mean
781011|NCT00808483|Primary|6 Minutes Walk Test (6MWT)|Participants walked in a 40 meter hospital corridor for 6 minutes.|5 months and 12 months|||meters||95% Confidence Interval|Mean
781012|NCT00808509|Secondary|Change From Baseline in Radiological Modified Total Sharp Score|The van der Heijde modified Total Sharp Score (mTSS) is a measure of the level of joint damage. X-rays of hands and feet were taken at Baseline, Week 52 and the Week 104-156 visit. Joints were scored for erosions on a scale of 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale of 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.|Baseline, Week 52, and Weeks 104-156|Full analysis set; N indicates the number of participants with available data at each time point.||units on a scale||Standard Deviation|Mean
781013|NCT00808509|Secondary|Work Productivity and Activity Impairment (WPAI): Daily Activities|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess work and activity impairment due to symptoms of rheumatoid arthritis in the last 7 days. The self-administered questionnaire consists of 6 questions. Question 6 asks participants to indicate how much their rheumatoid arthritis affected their ability to do their regular daily activities such as housework, childcare, exercising, shopping, studying, etc, in the past 7 days on a scale from 0 (no effect) to 10 (completely prevented from doing daily activities).|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set; N indicates the number of participants with available data at each time point.||units on a scale||Standard Deviation|Mean
781014|NCT00808509|Secondary|Work Productivity and Activity Impairment (WPAI): Work Productivity|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess work and activity impairment due to symptoms of rheumatoid arthritis in the last 7 days. The self-administered questionnaire consists of 6 questions. Question 5 asks participants who are employed or working for pay to indicate how much their rheumatoid arthritis impaired their productivity while working in the past 7 days on a scale from 0 (no effect) to 10 (completely prevented from working).|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set participants employed or working for pay; N indicates the number of participants employed or working for pay and with available data at each time point.||units on a scale||Standard Deviation|Mean
781015|NCT00808509|Secondary|Work Productivity and Activity Impairment (WPAI): Hours Worked|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess work and activity impairment due to symptoms of rheumatoid arthritis in the last 7 days. The self-administered questionnaire consists of 6 questions. Question 4 asks participants who are employed or working for pay to indicate the number of hours actually worked during the past 7 days.|Baseline and at Weeks 12, 28, 52 and 104-156|Full analysis set participants employed or working for pay and with available data at each time point.||hours||Standard Deviation|Mean
781016|NCT00808509|Secondary|Work Productivity and Activity Impairment (WPAI): Hours Missed From Work for Other Reasons|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess work and activity impairment due to symptoms of rheumatoid arthritis in the last 7 days. The self-administered questionnaire consists of 6 questions. Question 3 asks participants who are employed or working for pay to indicate the number of hours missed from work due to reasons other than rheumatoid arthritis.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set participants employed or working for pay; N indicates the number of participants employed or working for pay and with available data at each time point.||hours||Standard Deviation|Mean
781017|NCT00808509|Secondary|Work Productivity and Activity Impairment (WPAI): Hours Missed From Work|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess work and activity impairment due to symptoms of rheumatoid arthritis in the last 7 days. The self-administered questionnaire consists of 6 questions. Question 2 asks participants who are employed or working for pay to indicate the number of hours missed from work due to problems associated with their rheumatoid arthritis.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set participants employed or working for pay; N indicates the number of participants employed or working for pay and with available data at each time point.||hours||Standard Deviation|Mean
781018|NCT00808509|Secondary|Work Productivity and Activity Impairment (WPAI): Currently Employed|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess work and activity impairment due to symptoms of rheumatoid arthritis in the last 7 days. The self-administered questionnaire consists of 6 questions. Question 1 asks participants to indicate if they are currently employed or working for pay (Yes or No).|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set||participants|||Number
781019|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I'd Like Another Job But I am Restricted to What I Can do|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 23, participants selected either Yes or No if the following statement currently applied to them or not: I'd like another job but I am restricted to what I can do.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set||participants|||Number
781020|NCT00808509|Secondary|Work Instability Score (WIS) for RA: When I'm Feeling Tired All the Time Work is a Grind|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 22, participants selected either Yes or No if the following statement currently applies to them or not: When I'm feeling tired all the time work is a grind.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set||participants|||Number
781021|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I Get on With the Work But Afterwards I Have a Lot of Pain|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 21, participants selected either Yes or No if the following statement currently applies to them or not: I get on with the work but afterwards I have a lot of pain.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set||participants|||Number
781022|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I Feel I May Have to Give up Work|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 20, participants selected either Yes or No if the following statement currently applies to them or not: I feel I may have to give up work.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set||participants|||Number
781023|NCT00808509|Secondary|Work Instability Score (WIS) for RA: It's Very Frustrating Because I Can't Always do Things at Work|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 19, participants selected either Yes or No if the following statement currently applies to them or not: It's very frustrating because I can't always do things at work.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set||participants|||Number
785218|NCT00835614|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
781024|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I Have to Allow Myself Extra Time to do Some Jobs|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 18, participants selected either Yes or No if the following statement currently applies to them or not: I have to allow myself extra time to do some jobs.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set||participants|||Number
781025|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I Have Great Difficulty Opening Some of the Doors at Work|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 17, participants selected either Yes or No if the following statement currently applies to them or not: I have great difficulty opening some of the doors at work.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set||participants|||Number
781026|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I've Got to Watch How Much I do Certain Things at Work|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 16, participants selected either Yes or No if the following statement currently applies to them or not: I've got to watch how much I do certain things at work.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set||participants|||Number
781027|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I Have to Say No to Certain Things at Work|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 15, participants selected either Yes or No if the following statement currently applies to them or not: I have to say no to certain things at work.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set||participants|||Number
781028|NCT00808509|Secondary|Work Instability Score (WIS) for RA: Sometimes I Can't Face Being at Work All Day|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 14, participants selected either Yes or No if the following statement currently applies to them or not: Sometimes I can't face being at work all day.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set||participants|||Number
781029|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I Push Myself to go to Work Because I Don't Want to Give in to the Arthritis|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 13, participants selected either Yes or No if the following statement currently applies to them or not: I push myself to go to work because I don't want to give in to the arthritis.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set||participants|||Number
781030|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I Have Used my Vacation so That I Don't Have to Take Sick Leave|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 12, participants selected either Yes or No if the following statement currently applies to them or not: I have used my vacation so that I don't have to take sick leave.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set||participants|||Number
781031|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I Don't Have the Stamina to Work Like I Used to|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 11, participants selected either Yes or No if the following statement currently applies to them or not: I don't have the stamina to work like I used to.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set||participants|||Number
781032|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I Have Pain or Stiffness All the Time at Work|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 10, participants selected either Yes or No if the following statement currently applies to them or not: I have pain or stiffness all the time at work.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set||participants|||Number
781033|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I am Very Worried About my Ability to Keep Working|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 9, participants selected either Yes or No if the following statement currently applies to them or not: I am very worried about my ability to keep working.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set||participants|||Number
781034|NCT00808509|Secondary|Work Instability Score (WIS) for RA: If I Don't Reduce my Hours I May Have to Give up Work|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 8, participants selected either Yes or No if the following statement currently applied to them or not: If I don't reduce my hours I may have to give up work.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set||participants|||Number
781035|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I Can Get my Job Done, I'm Just a Lot Slower|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 7, participants selected either Yes or No if the following statement currently applied to them or not: I can get my job done, I'm just a lot slower.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set||participants|||Number
781036|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I Get Good Days and Bad Days at Work|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 6, participants selected either Yes or No if the following statement currently applied to them or not: I get good days and bad days at work.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set||participants|||Number
781037|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I'm Finding Any Pressure on my Hands is a Problem|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 5, participants selected either Yes or No if the following statement currently applied to them or not: I'm finding any pressure on my hands is a problem.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set||participants|||Number
781038|NCT00808509|Secondary|Work Instability Score (WIS) for RA: The Stress of my Job Makes my Arthritis Flare|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 4, participants selected either Yes or No if the following statement currently applied to them or not: The stress of my job makes my arthritis flare.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set||participants|||Number
781039|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I'm Finding my Job is About All I Can Manage|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 3, participants selected either Yes or No if the following statement currently applied to them or not: I'm finding my job is about all I can manage.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set||participants|||Number
781040|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I Get Very Stiff at Work|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 2, participants selected either Yes or No if the following statement currently applied to them or not: I get very stiff at work.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set||participants|||Number
781041|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I'm Getting up Earlier Because of Arthritis|Work Instability (defined as the mismatch between the person’s abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 1, participants selected either Yes or No if the following statement currently applied to them or not: I'm getting up earlier because of the arthritis.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set||participants|||Number
781042|NCT00808509|Secondary|Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale by Visit|The FACIT-Fatigue questionnaire is a self-administered patient questionnaire that consists of 13 questions designed to measure the degree of fatigue experienced by participants in the previous 7 days. Participants respond to the questions on a scale from 'not at all' (0) to 'very much' (4). The scale score is computed by summing the item scores, after reversing those items that are worded in the negative direction. The FACIT-Fatigue subscale score ranges from 0 to 52, where higher scores represent less fatigue.|Baseline and Weeks 4, 8, 12, 20, 28, 36, 44, 52, and 104-156 (extension period visit)|Full analysis set; N indicates the number of participants with available data.||units on a scale||Standard Deviation|Mean
781043|NCT00808509|Secondary|European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) by Visit|The EQ-5D is an international, standardized, generic instrument for describing and evaluating health status. Health status is assessed by patients evaluating their health on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (0) and 'Best imaginable health state' (100).|Baseline and Weeks 4, 8, 12, 20, 28, 36, 44, 52, and 104-156 (extension period visit)|Full analysis set; N indicates the number of participants with available data at each time point.||units on a scale||Standard Deviation|Mean
781044|NCT00808509|Secondary|European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit|"The EQ-5D is an international, standardized, generic instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their anxiety/depression health state:
Level 1: I am not anxious or depressed;
Level 2: I am moderately anxious or depressed;
Level 3: I am extremely anxious or depressed."|Baseline and Weeks 4, 8, 12, 20, 28, 36, 44, 52, and 104-156 (extension period visit)|Full analysis set||participants|||Number
781045|NCT00808509|Secondary|European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit|"The EQ-5D is an international, standardized, generic instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their pain/discomfort health state:
Level 1: I have no pain or discomfort;
Level 2: I have moderate pain or discomfort;
Level 3: I have extreme pain or discomfort."|Baseline and Weeks 4, 8, 12, 20, 28, 36, 44, 52, and 104-156 (extension period visit)|Full analysis set||participants|||Number
781046|NCT00808509|Secondary|European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit|"The EQ-5D is an international, standardized, generic instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state with regard to usual activities (work, study, housework, family, or leisure activities):
Level 1: I have no problems performing my usual activities;
Level 2: I have some problems performing my usual activities;
Level 3: I am unable to perform my usual activities."|Baseline and Weeks 4, 8, 12, 20, 28, 36, 44, 52, and 104-156 (extension period visit)|Full analysis set||participants|||Number
781047|NCT00808509|Primary|Percentage of Participants in Remission at Week 28 in the Full Analysis Set 2 (FAS2)|"Remission is defined as a Disease Activity Score (DAS)28 of less than 2.6. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein (CRP), and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.
In this analysis participants in the methotrexate treatment group with a DAS28 score ≥ 2.6 (and thus allocated to rescue therapy with adalimumab) prior to Week 28 were considered not to be in remission at Week 28. Also, participants who did not complete 28 weeks were considered not in remission."|Week 28|Full analysis set 2 (FAS2), defined as participants in the full analysis set who completed at least 28 weeks of the study or completed the study until flare, whichever occurs first.||percentage of participants||95% Confidence Interval|Number
781059|NCT00808639|Primary|Number of Patients Achieving Pathologic Response|Pathological response is defined as down-staging to </=pT1, N0 after chemotherapy with pegfilgrastim support.|After completion of 4 cycles of chemotherapy with pegfilgrastim support (cycle length 2 weeks)|Analysis population consists of all enrolled patients.||percentage of pathologic responders||90% Confidence Interval|Number
781048|NCT00808509|Secondary|European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit|"The EQ-5D is an international, standardized, generic instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their self-care health state:
Level 1: I have no problems with self-care;
Level 2: I have some problems washing or dressing myself;
Level 3: I am unable to wash or dress myself."|Baseline and Weeks 4, 8, 12, 20, 28, 36, 44, 52, and 104-156 (extension period visit)|Full analysis set||participants|||Number
781049|NCT00808509|Secondary|European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit|"The EQ-5D is an international, standardized, generic instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their mobility health state:
Level 1: I have no problems in walking about;
Level 2: I have some problems in walking about;
Level 3: I am confined to bed."|Baseline and Weeks 4, 8, 12, 20, 28, 36, 44, 52, and 104-156 (extension period visit)|Full analysis set||participants|||Number
781050|NCT00808509|Secondary|Health Assessment Questionnaire (HAQ) Total Score by Visit|Physical function was evaluated using the Health Assessment Questionnaire - Disability Index (HAQ-DI), a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. HAQ remission indicating normal physical function is defined by HAQ-DI < 0.5.|Baseline and Weeks 4, 8, 12, 20, 28, 36, 44, 52, and 104-156 (extension period visit)|Full analysis set; N indicates the number of participants with available data at each time point.||units on a scale||Standard Deviation|Mean
781051|NCT00808509|Secondary|Percentage of Participants With Response to Adalimumab Treatment (DAS28 <2.6 or DAS28 Decrease >1.2 Units) After a Flare|For participants with a flare and treated with adalimumab rescue therapy, response was defined as DAS28 less than 2.6 or DAS28 decrease of greater than 1.2 units after reinstitution of adalimumab (rescue therapy). The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein (CRP), and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.|1 to 4 weeks, 5 to 8 weeks, 9 to 12 weeks, and 13 to 16 weeks after reinstitution of adalimumab rescue therapy|Full analysis set participants in the methotrexate treatment group with a flare who were reinstituted adalimumab rescue therapy.||percentage of participants||95% Confidence Interval|Number
781052|NCT00808509|Secondary|Percentage of Participants With Response to Adalimumab Treatment (Return to Baseline DAS28 + ≤ 10%) After a Flare|"For participants with a flare and treated with adalimumab rescue therapy, response was defined as return to Baseline DAS28 + ≤ 10% after reinstitution of adalimumab (rescue therapy).
The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein (CRP), and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity."|1 to 4 weeks, 5 to 8 weeks, 9 to 12 weeks, and 13 to 16 weeks after reinstitution of adalimumab rescue therapy|Full analysis set participants in the methotrexate treatment group with a flare who were reinstituted adalimumab rescue therapy.||percentage of participants||95% Confidence Interval|Number
781053|NCT00808509|Secondary|Number of Participants With a Flare|Flare is defined as DAS28 ≥2.6 or an increase from Baseline in the DAS28 of greater than 1.2 units. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein (CRP), and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.|Baseline and Weeks 4, 8, 12, 20, 28, 36, 44, and 52|Full analysis set; N indicates the number of participants with available data at each time point.||participants|||Number
781054|NCT00808509|Secondary|Percentage of Participants in Remission at Week 52 (FAS2)|"Remission is defined as a Disease Activity Score (DAS)28 of less than 2.6. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein (CRP), and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity. Also, participants who did not complete 52 weeks were considered not in remission.
In this analysis participants in the methotrexate treatment group with a DAS28 score ≥ 2.6 (and thus allocated to rescue therapy with adalimumab) prior to Week 52 were considered not to be in remission at Week 52."|Week 52|Full analysis set 2||percentage of participants||95% Confidence Interval|Number
781055|NCT00808509|Secondary|Percentage of Participants in Remission at Week 52|"Remission is defined as a Disease Activity Score (DAS)28 of less than 2.6. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein (CRP), and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.
In this analysis participants in the methotrexate treatment group with a DAS28 score ≥ 2.6 (and thus allocated to rescue therapy with adalimumab) prior to Week 52 were considered not to be in remission at Week 52. Also, participants who did not complete 52 weeks were considered not in remission."|Week 52|Full analysis set||percentage of participants||95% Confidence Interval|Number
781056|NCT00808509|Primary|Percentage of Participants in Remission at Week 28|"Remission is defined as a Disease Activity Score (DAS)28 of less than 2.6. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein (CRP), and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.
In this analysis participants in the methotrexate treatment group with a DAS28 score ≥ 2.6 (and thus allocated to rescue therapy with adalimumab) prior to Week 28 were considered not to be in remission at Week 28. Also, participants who did not complete 28 weeks were considered not in remission."|Week 28|Full analysis set (FAS), defined as all participants who received at least one dose of adalimumab and/or methotrexate and had at least one post-baseline observation.||percentage of participants||95% Confidence Interval|Number
781844|NCT00799396|Primary|Changes in Platelet Function in Response to Clopidogrel Plus Aspirin|Baseline minus post clopidogrel/post-aspirin platelet rich plasma (PRP) maximum aggregation|Measured at baseline, and after clopidogrel plus aspirin treatment|||percentage of max aggregation change||Standard Deviation|Mean
781060|NCT00808769|Primary|The Mean Percent Time Gastric pH > 4.0 on Day 1|In this study, there was evidence of gastric pH probe failure and a high incidence of biologically improbable pH measurements (sustained pH < 1.0) that bring the validity of the results into question. The results of this study are, therefore, inconclusive.|continuously over a 24 hour period|Zeros are entered because the data are corrupted for 2 reasons: probe calibration failure rate was ~10x higher than historically documented, and the probes that calibrated had a high incidence of prolonged pH < 1.0 (highly physiologically improbable). This calls into question the credibility and interpretability of all the pH data.|||||
781061|NCT00808808|Secondary|Characteristics of Participants 18-49 Years of Age Choosing FluMist vs TIV: Gender|Percent of participants 18-49 years of age who chose FluMist vs TIV for influenza vaccination and who self-identified as male.|30Sep2008 through 23Dec2008|All participants who completed surveys and were eligible to receive FluMist||percent|||Number
781062|NCT00808808|Secondary|Characteristics of Participants 18-49 Years of Age Choosing FluMist vs TIV: Education|Percent of participants 18-49 years of age who chose FluMist vs TIV for influenza vaccination and who self-identified as college graduates.|30Sep2008 through 23Dec2008|All participants who completed surveys and were eligible to receive FluMist||percent|||Number
781063|NCT00808808|Secondary|Characteristics of Participants 18-49 Years of Age Choosing FluMist vs TIV: Race|Percent of participants 18-49 years of age who chose FluMist vs TIV for influenza vaccination and who self-identified as white|30Sep2008 through 23Dec2008|All participants who completed surveys and were eligible to receive FluMist||percent|||Number
781064|NCT00808808|Secondary|Percent of Eligible Participants 18-49 Years of Age Choosing FluMist During Intervention Season||30Sep2008 through 23Dec2008|All vaccinated employees 18-49 years of age at participating sites, including those who completed surveys and those who did not||percent|||Number
781065|NCT00808808|Secondary|Change in Influenza Vaccination Rate From Baseline Season to Intervention Season in Employees 18-49 Years of Age|Rate difference by arm from baseline to intervention season|2007-2008 season through 2008-2009 season|All vaccinated employees 18-49 years of age at participating sites, including those who completed surveys and those who did not||percentage points|||Number
781066|NCT00808808|Secondary|Change in Influenza Vaccination Rate From Baseline Season to Intervention Season in the Total Population|Rate difference by arm from baseline to intervention season|2007-2008 season through 2008-2009 season|All vaccinated employees at participating sites, including those who completed surveys and those who did not||percentage points|||Number
781067|NCT00808808|Primary|Overall Vaccination Rate, Employees 18 to 49 Years of Age||30Sep2008 through 23Dec2008|All vaccinated employees at participating sites, including those who completed surveys and those who did not||Percentage of participants|||Number
781068|NCT00808808|Primary|Overall Vaccination Rate, All Ages||30Sep2008 through 23Dec2008|All employees at participating sites, including those who were vaccinated and those who were not||Percentage of participants|||Number
781069|NCT00808834|Primary|Comfort After Insertion|Evaluated by the subject and measured on a 10-point scale, with 1 being poor and 10 being excellent.|30-60 seconds after initial insertion|Per protocol||Scale 1-10||Standard Deviation|Mean
781070|NCT00808899|Primary|Complete Response Plus Partial Response|The objective was to measure the efficacy and feasability of Temsirolimus and Irinotecan as measured by the objective response rate and toxicity rate.|10 years|The population consisted of patients eligible for enrollment onto the NB2008 protocol.|||||
781071|NCT00809055|Secondary|Bayley Scales of Infant Development Cognitive Score at 2 Years of Age|The cognitive portion of the Bayley Scales of Infant Development assesses development in infants and toddlers between the ages of 0 and 3 years. Raw scores are converted to scale scores. A scale score of 100 is designed to represent the population mean. Scores below 100 represent developmental delay relative to the mean and scores above 100 represent advanced development relative to the mean.|2 years|13 patients excluded from high-dose group (7 died, 2 withdrew, 2 we were unable to contact, 2 did not comply with scheduled appointments). 15 patients excluded from standard-dose group (5 died, 2 withdrew, 5 we were unable to contact, 3 did not comply with scheduled appointments).||score||Standard Deviation|Mean
781072|NCT00809055|Secondary|Infant Neurobehavioral Scoring by Dubowitz Scale Prior to Discharge|The Dubowitz Neurologic Examination is a standardized neurologic examination for infants at term age. It includes 6 compound optimality scores summed to obtain the total optimality score. Compound optimality scores include tone (range 0-10), tone pattern (range 0-5), reflexes (range 0-6), movements (range 0-3), abnormal signs (range 0-3), and behavior (range 0-7). The range for the compound optimality score is 0 - 34, with scores between 30.5 and 34 considered optimal and scores below 30.5 considered suboptimal.|Participants were followed for the duration of hospital stay, an average of 12 weeks|9 patients excluded from high-dose group (7 died, 2 withdrew). 6 patients excluded from standard-dose group (5 died, 1 transferred).||scores on a scale||Standard Deviation|Mean
781073|NCT00809055|Secondary|Evaluation of EEG Seizure Burden|For the first 72 hours of life, infants were monitored for seizures using continuous limited channel aEEG. Seizures were defined as a series of sharp waves, at least ten seconds in duration, which evolve in frequency, amplitude, and morphology over time and are clearly distinguishable from the background or artifact.|First 72 hours of life|7 patients excluded from high-dose group and 8 from standard-dose group due to recordings < 6 hours or corrupt data files.||seconds||Standard Deviation|Mean
781074|NCT00809055|Secondary|Rates of Retinopathy of Prematurity||Participants were followed for the duration of hospital stay, an average of 12 weeks|||participants|||Number
781075|NCT00809055|Secondary|Rates of Necrotizing Enterocolitis||Participants were followed for the duration of hospital stay, an average of 12 weeks|||participants|||Number
781076|NCT00809055|Secondary|Rates of Chronic Lung Disease|Defined as oxygen requirement at 36 weeks PMA|Participants were followed for the duration of hospital stay, an average of 12 weeks|||participants|||Number
781077|NCT00809055|Secondary|Length of Time Requiring Invasive Respiratory Support||Participants were followed for the duration of hospital stay, an average of 12 weeks|||days||Inter-Quartile Range|Median
781078|NCT00809055|Secondary|Cerebellar Hemorrhage||Participants were followed for the duration of hospital stay, an average of 12 weeks|||participants|||Number
781079|NCT00809055|Secondary|Mortality Rates||Participants were followed for the duration of hospital stay, an average of 12 weeks|||participants|||Number
781080|NCT00809055|Primary|White Matter Microstructural Maturation|Apparent diffusion coefficient is a measure of microstructural maturation obtained from brain MRI.|Participants were followed for the duration of hospital stay, an average of 12 weeks|12 patients excluded from high-dose group (7 died, 2 withdrew, 3 insufficient image quality). 10 patients excluded from standard-dose group (5 died, 1 transferred, 1 parent refused MRI, 3 insufficient image quality).||apparent diffusion coefficient||Standard Deviation|Mean
781081|NCT00809094|Other Pre-specified|Change in ECHO Tricuspid Regurgitation (mm Hg) Over Time by Treatment Group|Change in measure of estimated right ventricular pressure over the 24-week study period|Baseline to 24 weeks|Sixteen subjects at Stanford University were enrolled as an initial safety cohort, and their data was used to evaluate the potential for NAC to cause PH in CF subjects. 1 subject in NAC cohort has missing data. It was not imputed||mm Hg||Standard Deviation|Mean
781082|NCT00809094|Other Pre-specified|Change in DLCO (ml/Min/mmHg) Over Time by Treatment Group|Change in the diffusing capacity of carbon monoxide across the lung measured from baseline to end of 24-week study.|Baseline to 24 weeks|Sixteen subjects at Stanford University were enrolled as an initial safety cohort, and their data was used to evaluate the potential for NAC to cause PH in CF subjects.||ml/min/mm Hg||Standard Deviation|Mean
781083|NCT00809094|Secondary|FEF 25-75% (Percent of Predicted)|Difference in the forced expiratory flow rate in mid-exhalation as a percent of predicted to standard values measured from baseline to the end of study (24 weeks).|Baseline to 24 weeks|Out of 70 subjects randomized, 65 completed the Week 12 visit and 62 completed the study. There were 6 withdrawals in the NAC group and 2 in Placebo. Five out of 6 subjects in the NAC group withdrew due to subject decision. Missing data was not imputed.||percent of predicted||95% Confidence Interval|Mean
781084|NCT00809094|Secondary|FEF 25-75% (L/Sec)|Difference in mid-expiratory flow rates between 25 to 75% of the vital capacity, in L/sec measured at the beginning of the study to the end of the study.|Baseline to end of study (24 weeks)|Out of 70 subjects randomized, 65 completed the Week 12 visit and 62 completed the study. There were 6 withdrawals in the NAC group and 2 in Placebo. Five out of 6 subjects in the NAC group withdrew due to subject decision. Missing data was not imputed.||L/sec||95% Confidence Interval|Mean
781085|NCT00809094|Secondary|FEV1 (L)|Forced expiratory volume in 1 second (Liters)|Baseline to end of study (24 weeks)|Out of 70 subjects randomized, 65 completed the Week 12 visit and 62 completed the study. There were 6 withdrawals in the NAC group and 2 in Placebo. Five out of 6 subjects in the NAC group withdrew due to subject decision. Missing data was not imputed.||Liter||95% Confidence Interval|Number
781086|NCT00809094|Secondary|Change in FEV1 (Percent of Predicted for Age)|Change in forced expiratory volume in 1 second as compared to normals for age (percent of predicted)|From enrollment to the end of the 24-week trial|Out of 70 subjects randomized, 65 completed the Week 12 visit and 62 completed the study. There were 6 withdrawals in the NAC group and 2 in Placebo. Five out of 6 subjects in the NAC group withdrew due to subject decision. Missing data was not imputed.||percent of predicted vlaues||95% Confidence Interval|Number
781087|NCT00809094|Primary|Change in the Logarithm of the Level of Human Neutrophil Elastase (HNE) Activity Measured in Sputum|(change in log10 HNE in the active treatment group) – (change in log10 HNE in the placebo group)|From enrollment to end of the 24-week trial|The primary endpoint analyses described uses the subset of the ITT population with complete case data. 70 subjects randomized, 65 completed the Week 12 visit and 62 completed the study. There were 6 withdrawals in the NAC group and 2 in Placebo. Five out of 6 subjects in the NAC group withdrew due to subject decision. Missing data was not imputed.||log10 mcg/mL||95% Confidence Interval|Log Mean
781088|NCT00809133|Secondary|Objective Tumour Response (Confirmed)|"Number of subjects with confirmed objective tumour response.
Objective Response (OR) was defined as Complete Response (CR) or Partial Response (PR). Objective response was to be confirmed by a second tumour assessment at least 4 weeks after the assessment of CR or PR."|From first drug administration until the last trial drug administration, up to 1156 days.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.||Participants|||Number
781089|NCT00809133|Secondary|Objective Tumour Response (Unconfirmed)|"Number of subjects with objective tumour response (unconfirmed).
Objective Response (OR) was defined as Complete Response (CR) or Partial Response (PR)."|From first drug administration until the last trial drug administration, up to 1156 days.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.||Participants|||Number
781090|NCT00809133|Secondary|Part D: Carboplatin Cmax in Cycle 1 and 2|Maximum measured concentration of Carboplatin in plasma.|Cycle 1, day 1 and cycle 2, day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00 and 24:00.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
781091|NCT00809133|Secondary|Part D: Area Under the Concentration-Time Curve of Carboplatin in Plasma Over the Time Interval From 0 Extrapolated Upto 24 Hours in Cycle 1 and Cycle 2|AUC0-24: Area under the concentration-time curve of Carboplatin in plasma over the time interval from zero extrapolated to 24 hours.|Cycle 1, day 1 and cycle 2, day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00 and 24:00|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
781092|NCT00809133|Secondary|Part D: Paclitaxel Cmax in Cycle 1 and 2|Maximum measured concentration of Paclitaxel in plasma.|Cycle 1, day 1 and cycle 2, day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00 and 24:00|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
781093|NCT00809133|Secondary|Part D: Area Under the Concentration-Time Curve of Paclitaxel in Plasma Over the Time Interval From 0 Extrapolated Upto 23 Hours in Cycle 1 and Cycle 2|AUC0-23: Area under the concentration-time curve of Paclitaxel in plasma over the time interval from zero extrapolated to 23 hours.|Cycle 1, day 1 and cycle 2, day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00 and 23:00.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
781094|NCT00809133|Secondary|Part D: Afatinib Cmax,ss|Maximum measured concentration of Afatinib in plasma at steady state.|Cycle 2, day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00 and 24:00.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
781095|NCT00809133|Secondary|Part D: AUCt,ss: Area Under the Concentration-Time Curve of Afatinib in Plasma at Steady State.|AUCt,ss: Area under the concentration-time curve of Afatinib at steady state.|Cycle 2, day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00 and 24:00.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
781096|NCT00809133|Secondary|Part C: Carboplatin Cmax in Cycle 1 and Cycle 2|Maximum measured concentration of Carboplatin in plasma.|Cycle 1, day 1 and cycle 2, day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 24:00|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
781097|NCT00809133|Secondary|Part C: Area Under the Concentration-Time Curve of Carboplatin in Plasma Over the Time Interval From 0 Extrapolated Upto 24 Hours in Cycle 1 and Cycle 2|AUC0-24: Area under the concentration-time curve of Carboplatin in plasma over the time interval from zero extrapolated to 24 hours.|Cycle 1, day 1 and cycle 2, day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 24:00.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
781098|NCT00809133|Secondary|Part C: Afatinib Cmax,ss in Cycle 2|Maximum measured concentration of Afatinib in plasma at steady state.|Cycle 2, day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00 and 24:00.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
781099|NCT00809133|Secondary|Part C: AUCt,ss: Area Under the Concentration-Time Curve of Afatinib in Plasma at Steady State in Cycle 2|AUCt,ss: Area under the concentration-time curve of Afatinib in plasma at steady state.|Cycle 2, day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00 and 24:00.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
781100|NCT00809133|Secondary|Part B: Bevacizumab Plasma Concentration|Bevacizumab plasma concentration after infusion of Bevacizumab 5mg/kg after end of 1st and 2nd infusion in Cycle 1.|Day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 24:00. Day 15: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 24:00.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.||μg/mL||Inter-Quartile Range|Median
781101|NCT00809133|Secondary|Part B: Paclitaxel Cmax on Day 1 and Day 15|Maximum measured concentration of Paclitaxel in plasma.|Day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 24:00. Day 15: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 24:00.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
781102|NCT00809133|Secondary|Part B: Area Under the Concentration-Time Curve of Paclitaxel in Plasma Over the Time Interval From 0 Extrapolated Upto 24 Hours on Day 1 and Day 15|AUC0-24: Area under the concentration-time curve of Paclitaxel in plasma over the time interval from zero extrapolated to 24 hours.|Day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 24:00. Day 15: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 24:00.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
781103|NCT00809133|Secondary|Part B: Afatinib Cmax,ss on Day 15|Maximum measured concentration of Afatinib in plasma at steady state.|Day 15: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00 and 24:00.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
781104|NCT00809133|Secondary|Part B: AUCt,ss: Area Under the Concentration-Time Curve of Afatinib in Plasma at Steady State on Day 15|Area under the concentration-time curve of Afatinib in plasma at steady state.|Day 15: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 24:00. There were no analyzable patients for Part B: A30P80B5 (Afatinib + Paclitaxel + Bevacizumab.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
781105|NCT00809133|Secondary|Part A: Paclitaxel Cmax on Day 1 and Day 15|Maximum measured concentration of Paclitaxel in plasma.|Day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 24:00. Day 15: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 24:00.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
781106|NCT00809133|Secondary|Part A: AUC0-24: Area Under the Concentration-Time Curve of Paclitaxel in Plasma Over the Time Interval From Zero Extrapolated to 24 Hours on Day 1 and Day 15|AUC0-24: Area under the concentration-time curve of Paclitaxel in plasma over the time interval from zero extrapolated to 24 hours.|Day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 24:00. Day 15: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 24:00.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
781107|NCT00809133|Secondary|Part A: Afatinib Cmax,ss on Day 15|Maximum measured concentration of Afatinib in plasma at steady state.|Day 15: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00 and 24:00.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
781108|NCT00809133|Secondary|Part A: AUCt,ss: Area Under the Concentration-Time Curve of Afatinib in Plasma at Steady State on Day 15|Area under the concentration-time curve of Afatinib in plasma at steady state.|Day 15: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00 and 24:00.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
781109|NCT00809133|Secondary|Incidence and Intensity of AEs According to the Maximum Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Grade|Incidence and Intensity of AEs (Adverse Events) graded according to the maximum CTCAE (Common Toxicity Criteria for Adverse Events) grade based on the number of patients with AEs with CTCAE Grade 1-5.|From first drug administration until the end of treatment cycle 1; 21 days (part C and D) or 28 days (part A and B)|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.||Participants|||Number
781393|NCT00788957|Secondary|Part 1: Maximum Observed Drug Concentration (Cmax) and Minimum Drug Concentration (Cmin) for Panitumumab and Rilotumumab||Week 5 (third dose) at pre-dose, 5 minutes after infusion and at 24, 48 and 96, and 168 hours post infusion.|Part 1 participants for whom intensive pharmacokinetic samples after the third dose (Week 5) were available.||μg/ml||Standard Deviation|Mean
781110|NCT00809133|Primary|Maximum Tolerated Dose (MTD)|"The MTD of afatinib in selected combination treatments was defined as the highest dose at which no more than 1 out of 6 patients experienced DLTs during the first treatment cycle, i.e. the highest dose with a DLT incidence ≤17%. The MTD was determined separately for Afatinib in combination with Paclitaxel (part A), Afatinib in combination with Paclitaxel and Bevacizumab (part B), Afatinib and Carboplatin (part C), and Afatinib in combination with Paclitaxel and Carboplatin (part D).
In part C, dose escalation was not continued beyond the dose level A40C6, due to safety and pharmacokinetic considerations and upon mutual agreement between the investigators and the sponsor. Formally, no MTD was determined, however a recommended phase II dose was determined and is presented here.
0=not maximum tolerated dose, 1=is maximum tolerated dose
Note, the depicted order of treatment groups is driven by dose level, not by the actual dosing steps."|Cycle 1: 21 days (part C and D) or 28 days (part A and B)|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.||Units on a scale|||Number
781111|NCT00809133|Primary|Number of Participants With Dose Limiting Toxicities (DLTs) in the First Cycle for the Determination of the Maximum Tolerated Dose (MTD)|Dose limiting toxicity (DLT) was defined as an Adverse Event (AE) or laboratory abnormality considered as related to study treatment.|Cycle 1: 21 days (part C and D) or 28 days (part A and B)|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.||Participants|||Number
781112|NCT00809146|Secondary|Length of Hospital Stay in Days|Continuous acute care inpatient hospital days from day of admission until discharge|participants were followed for the duration of hospital stay, an average of 6 days|All subjects with hospital length of stay data||days||Standard Deviation|Mean
781113|NCT00809146|Secondary|Length of Intensive Care Unit (ICU) Stay in Days|Continuous days of initial ICU stay from time of admission|participants were followed for the duration of hospital stay, an average of 6 days|All participants with ICU length of stay data||days||Standard Deviation|Mean
781114|NCT00809146|Secondary|Number of Subjects With IV Injection-site Complications|IV insertion site complications are defined as any symptoms or signs of injury or reaction at the site of the study IV placed by paramedics and used for study medication. This includes thrombosis, phlebitis, or skin infection requiring specific treatment including compresses, antibiotics, or wound care.|participants were followed for the duration of hospital stay, an average of 6 days|||participants|||Number
781115|NCT00809146|Secondary|Number of Subjects With IM Injection-site Complications|IM injection site complications are defined as any symptoms or signs of injury or reaction at the site of the study IM injection requiring treatment. This includes extensive hematoma requiring treatment (decompression, pressure dressings, or discontinuation of anticoagulant or antithrombotic medications). Treatment does not include imaging without other interventions. This definition also includes wound infection requiring antibiotic therapy, retained foreign bodies requiring exploration and removal, or other similar wound problems.|participants were followed for the duration of hospital stay, an average of 6 days|||participants|||Number
781116|NCT00809146|Secondary|Number of Subjects With Hypotension|Acute hypotension is defined as a systolic blood pressure of < 90 mmHg sustained for greater than 5 minutes and for which the patient was treated with a continuous IV infusion of a vasopressor.|participants were followed for the duration of hospital stay, an average of 6 days|||participants|||Number
781117|NCT00809146|Secondary|Number of Subjects With Recurrent Seizure Within 12 Hours After ED Arrival|Acute seizure recurrence is defined as any further convulsive or electrographic seizures occurring in the first 12 hours of hospitalization, if they require additional antiepileptic medications, in subjects that had been determined not to be having seizures on ED arrival.|within 12 hours after ED arrival|||participants|||Number
781118|NCT00809146|Secondary|Number of Subjects Admitted to an Intensive Care Unit (ICU)|Hospital and ICU admission from the ED, and length of stay, is abstracted from the hospital admission record. ICU admission is recorded as occurring only if the ICU is the initial inpatient unit for the patient.|at time of disposition on day of enrollment|||participants|||Number
781119|NCT00809146|Secondary|Number of Subjects Hospitalized|Hospital and ICU admission from the ED, and length of stay, is abstracted from the hospital admission record. ICU admission is recorded as occurring only if the ICU is the initial inpatient unit for the patient.|at ED disposition on day of enrollment|||participants|||Number
781120|NCT00809146|Secondary|Number of Subjects With Endotracheal Intubation Within 30 Min After ED Arrival|Endotracheal intubation performed or attempted by EMS or within 30 minutes after ED arrival is abstracted from the ED record physician and nursing records. Endotracheal intubation includes placement of a definitive tracheal airway (oro-, naso-, cricothyroidotomy, or tracheostomy) for support of respirations or protection of airway. Non-definitive and/or non-tracheal airways (oral or nasal airways, laryngeal mask airways, or esophageal obturator airways) are not included if the patient is not subsequently intubated unless specifically deemed to have been used in lieu of tracheal intubation.|anytime before 30 minutes after ED arrival|||participants|||Number
781121|NCT00809146|Primary|Number of Subjects With Termination of Seizures at ED Arrival With no Rescue Therapy Given|The primary outcome was termination of seizures before arrival in the emergency department (ED) without the need for the paramedics to provide rescue therapy. Subjects did not reach the primary outcome if they were having seizures on arrival in the emergency department or if they received rescue medication before arrival. Termination of seizures on arrival was determined according to the clinical judgment of the attending emergency physician and was based on examination of the subjects, their clinical course, and results of any routine diagnostic testing.|Duration of prehospital care, outcome is determined upon arrival at the ED on the day of enrollment (average 20 minutes).|||participants|||Number
781129|NCT00809159|Secondary|PK of AIN457: Terminal Elimination Half-life (T1/2) in Part 1|Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28|Week 28|Pharmacokinetic Analysis set: All patients with quantifiable PK measurements and no major protocol deviations with impact on PK data. Due to several discontinuations, the full set of PK parameters could not be obtained in all treated patients. Patients who received only one infusion and/or had a too short PK sampling period were excluded||day||Standard Deviation|Mean
781264|NCT00810199|Secondary|Time to Flare After Tocilizumab Remission|The time in days to a flare (recurrence of disease symptoms) after the patient discontinued treatment with tocilizumab.|104 Weeks|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for this outcome measure. Participants were censored at the last observed value.||Days||Full Range|Median
781122|NCT00809159|Secondary|Change From Baseline in the Health Related Quality of Life (HRQoL) by Using the SF-36 Physical Component, and the ASQoL (Ankylosing Spondylitis Quality of Life Instrument) in Part 1 and 2.|"The SF-36 measures the impact of disease on overall quality of life and consists of eight subscales (physical function, pain, general and mental health, vitality, social function, physical and emotional health) which can be aggregated to derive a physical-component summary score and a mental-component summary score. ASQoL determined subject's quality of life and is comprised of 18 questions (yes or no) to be completed by the subject. Each statement on the ASQoL is given a score of 1 or 0. All item scores were summed to give a total score or index. Total scores ranged from 0 (good quality of life) to 18 (poor quality of life) related to ability to cope, relationships, mood, sleep, motivation, activities of everyday living, independence, and social life. Decrease in ASQoL score represents improvement."|SF-36: Baseline, week 12, week 28; ASQoL: Baseline, day 29, week 12, week 8|Pharmacodynamic Analysis set: All patients with a least one evaluable post-treatment PD measurement and no major protocol deviations with impact on PD data were included. One subjects was excluded from the PD set in the AIN457 10mg/kg Part 2 due to the absence of available post-baseline PD measurements||Score||Standard Deviation|Mean
781123|NCT00809159|Secondary|Change From Baseline in the Health Related Quality of Life (HRQoL) by Using the SF-36 Physical Component, and the ASQoL (Ankylosing Spondylitis Quality of Life Instrument) in Part 1.|"The Short Form (36) Health Survey (SF-36) measures the impact of disease on overall quality of life and consists of eight subscales (physical function, pain, general and mental health, vitality, social function, physical and emotional health) which can be aggregated to derive a physical-component summary score and a mental-component summary score. Scores range for each subscale from 0 to 10, and the composite score ranges from 0 to 100, with higher scores indicative of better health. ASQoL determined subject's quality of life and is comprised of 18 questions (yes or no) to be completed by the subject. Each statement on the ASQoL is given a score of 1 or 0. All item scores were summed to give a total score or index. Total scores ranged from 0 (good quality of life) to 18 (poor quality of life) related to ability to cope, relationships, mood, sleep, motivation, activities of everyday living, independence, and social life. Decrease in ASQoL score represents improvement."|SF-36:Baseline, week 12, week 28; ASQoL: Baseline, Day 29, week 12, week 28|Pharmacodynamic Analysis set: All patients with a least one evaluable post-treatment PD measurement and no major protocol deviations with impact on PD data were included. One subjects was excluded from the PD set in the AIN457 10mg/kg Part 2 due to the absence of available post-baseline PD measurements||Score||Standard Deviation|Mean
781124|NCT00809159|Secondary|Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1 and 2|MASES is measured by scoring of entheses of 0 (no tenderness) to 3 (severe tenderness) at 13 sites on the body. The score was derived as the sum of the 13 scores divided by 3 and the total range is 0 (no tenderness) to 13 (severe tenderness).|Day 8,15,29,week, 6, 10,12,16,20,24,28|Pharmacodynamic Analysis set: All patients with a least one evaluable post-treatment PD measurement and no major protocol deviations with impact on PD data were included. One subjects was excluded from the PD set in the AIN457 10mg/kg Part 2 due to the absence of available post-baseline PD measurements||Score||Standard Deviation|Mean
781125|NCT00809159|Secondary|Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1|MASES is measured by scoring of entheses of 0 (no tenderness) to 3 (severe tenderness) at 13 sites on the body. The score was derived as the sum of the 13 scores divided by 3 and the total range is 0 (no tenderness) to 13 (severe tenderness).|Baseline, day 8,15,29,week, 6, 8,10,12,16,20,24,28|Pharmacodynamic Analysis set: All patients with a least one evaluable post-treatment PD measurement and no major protocol deviations with impact on PD data were included. One subjects was excluded from the PD set in the AIN457 10mg/kg Part 1 due to protocol deviation||Score||Standard Deviation|Mean
781126|NCT00809159|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Part 1 and 2|The BASDAI consists of a 1 through 10 scale (1 being no problem and 10 being the worst problem), which was used to answer 6 questions pertaining to the 5 major symptoms of AS: Fatigue, Spinal pain, Joint pain / swelling, areas of localized tenderness (called enthesitis, or inflammation of insertion sites of tendons and ligaments), morning stiffness duration, and morning stiffness severity. The physician will globally assess the subject's current disease state using a visual analog scale (VAS) scale with 0 being very good and 100 being very bad.|Baseline, day 8,15,29,week 6,8,10,12,16,20,24,28|Pharmacodynamic Analysis set: All patients with a least one evaluable post-treatment PD measurement and no major protocol deviations with impact on PD data were included. One subjects was excluded from the PD set in the AIN457 10mg/kg Part 2 due to the absence of available post-baseline PD measurements||Score||95% Confidence Interval|Least Squares Mean
781127|NCT00809159|Secondary|Mean Change Bath Ankylosing Spondylitis Metrology Index (BASMI) Score in Part 1 and 2|BASMI measures the range of motion based on five clinical measurements: 1) cervical rotation, 2) tragus to wall distance, 3) lumbar side flexion, 4) lumbar flexion (modified Schober's) and 5) intermalleolar distance. BASMI 0 = indicates mild disease involvement, 1 = moderate disease, and 2 = severe disease involvement. The results for cervical rotation and lumbar side flexion are the means of the left and right measurements. Scoring range 0-10. The higher the BASMI score, the more severe was the subject's limitation of movement|Baseline, day 8,15,29, week 6,8,10,12,16,20,24,28|Pharmacodynamic Analysis set: All patients with a least one evaluable post-treatment PD measurement and no major protocol deviations with impact on PD data were included. One subjects was excluded from the PD set in the AIN457 10mg/kg Part 2 due to the absence of available post-baseline PD measurements||Score||Standard Deviation|Mean
781128|NCT00809159|Secondary|PK of AIN457: Terminal Elimination Half-life (T1/2) in Part 1 and 2|Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28|Week 28|Pharmacokinetic Analysis set: All patients with quantifiable PK measurements and no major protocol deviations with impact on PK data. Due to several discontinuations, the full set of PK parameters could not be obtained in all treated patients. Patients who received only one infusion and/or had a too short PK sampling period were excluded||day||Standard Deviation|Mean
781198|NCT00809757|Secondary|Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoint at Visit 4||Visit 4: pre-dose (approximately 28 days after randomization) , 30 minutes post-dose, 1 hour post-dose, 4 hours post-dose, 6 hours post-dose|Intent-to-Treat Population – PEF Cohort (Subjects able to perform PEFs)||liters||Standard Deviation|Mean
781130|NCT00809159|Secondary|PK of AIN457: Volume of Distribution During the Terminal Phase Following Intravenous Elimination (Vz) in Part 1 and 2|Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28|Week 28|Pharmacokinetic Analysis set: All patients with quantifiable PK measurements and no major protocol deviations with impact on PK data. Due to several discontinuations, the full set of PK parameters could not be obtained in all treated patients. Patients who received only one infusion and/or had a too short PK sampling period were excluded||Liters||Standard Deviation|Mean
781131|NCT00809159|Secondary|PK of AIN457: Volume of Distribution During the Terminal Phase Following Intravenous Elimination (Vz) in Part 1|Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28|Week 28|Pharmacokinetic Analysis set: All patients with quantifiable PK measurements and no major protocol deviations with impact on PK data. Due to several discontinuations, the full set of PK parameters could not be obtained in all treated patients. Patients who received only one infusion and/or had a too short PK sampling period were excluded||Liters||Standard Deviation|Mean
781132|NCT00809159|Secondary|PK of AIN457: Systemic Clearance From Serum Following Intravenous Administration (CL) in Part 1 and 2|Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28|Week 28|Pharmacokinetic Analysis set: All patients with quantifiable PK measurements and no major protocol deviations with impact on PK data. Due to several discontinuations, the full set of PK parameters could not be obtained in all treated patients. Patients who received only one infusion and/or had a too short PK sampling period were excluded||Liters/day||Standard Deviation|Mean
781133|NCT00809159|Secondary|PK of AIN457: Systemic Clearance From Serum Following Intravenous Administration (CL) in Part 1|Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28|Week 28|Pharmacokinetic Analysis set: All patients with quantifiable PK measurements and no major protocol deviations with impact on PK data. Due to several discontinuations, the full set of PK parameters could not be obtained in all treated patients. Patients who received only one infusion and/or had a too short PK sampling period were excluded||Liters/day||Standard Deviation|Mean
781134|NCT00809159|Secondary|PK of AIN457: Area Under the Serum Concentration-time Cure From Time Zero to the Time of Last Quantifiable Concentration (AUClast), Area Under the Serum Concentration-time Curve From Time Zero to (AUCinf) in Part 1 and 2|Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28|Week 28|Pharmacokinetic Analysis set: All patients with quantifiable PK measurements and no major protocol deviations with impact on PK data. Due to several discontinuations, the full set of PK parameters could not be obtained in all treated patients. Patients who received only one infusion and/or had a too short PK sampling period were excluded||day*ug/mL||Standard Deviation|Mean
781135|NCT00809159|Secondary|PK of AIN457: Area Under the Serum Concentration-time Cure From Time Zero to the Time of Last Quantifiable Concentration (AUClast), Area Under the Serum Concentration-time Curve From Time Zero to (AUCinf) in Part 1|Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28|Week 28|Pharmacokinetic Analysis set: All patients with quantifiable PK measurements and no major protocol deviations with impact on PK data. Due to several discontinuations, the full set of PK parameters could not be obtained in all treated patients. Patients who received only one infusion and/or had a too short PK sampling period were excluded||day*ug/mL||Standard Deviation|Mean
781136|NCT00809159|Secondary|PK of AIN457: Observed Maximum Serum Concentration Following Drug Administration (Cmax) in Part 1 and 2|Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28|Week 28|Pharmacokinetic Analysis set: All patients with quantifiable PK measurements and no major protocol deviations with impact on PK data. Due to several discontinuations, the full set of PK parameters could not be obtained in all treated patients. Patients who received only one infusion and/or had a too short PK sampling period were excluded||ug/mL||Standard Deviation|Mean
781137|NCT00809159|Secondary|PK of AIN457: Observed Maximum Serum Concentration Following Drug Administration (Cmax) in Part 1|Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28|Week 28|Pharmacokinetic Analysis set: All patients with quantifiable PK measurements and no major protocol deviations with impact on PK data. Due to several discontinuations, the full set of PK parameters could not be obtained in all treated patients. Patients who received only one infusion and/or had a too short PK sampling period were excluded||ug/mL||Standard Deviation|Mean
781138|NCT00809159|Secondary|Pharmacokinetics (PK) of AIN457: Time to Reach the Maximum Concentration After Drug Administration (Tmax) in Part 1 and 2|Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28.|Week 28|Pharmacokinetic Analysis set: All patients with quantifiable PK measurements and no major protocol deviations with impact on PK data. Due to several discontinuations, the full set of PK parameters could not be obtained in all treated patients. Patients who received only one infusion and/or had a too short PK sampling period were excluded.||Days||Full Range|Median
781139|NCT00809159|Secondary|Pharmacokinetics (PK) of AIN457: Time to Reach the Maximum Concentration After Drug Administration (Tmax) in Part 1|Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28.|Week 28|Pharmacokinetic Analysis set: All patients with quantifiable PK measurements and no major protocol deviations with impact on PK data. Due to several discontinuations, the full set of PK parameters could not be obtained in all treated patients. Patients who received only one infusion and/or had a too short PK sampling period were excluded.||Days||Full Range|Median
781199|NCT00809757|Secondary|Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoint at Visit 3||Baseline, Visit 3, pre–dose (approximately 14 days after randomization)|Intent-to-Treat Population – PEF Cohort (Subjects able to perform PEFs)||liters||Standard Deviation|Mean
781416|NCT00794547|Secondary|To Correlate the Pharmacokinetic Parameters of Systemic Calcitriol Exposure (AUC) With SNPs of the 24-hydroxylase (CYP24), the Major Vitamin D3 Inactivating Enzyme.||3-6 months||||||
781140|NCT00809159|Secondary|Magnetic Resonance Imaging (MRI) Inflammatory Scores at Baseline, Week 6 in Part 1|The study used MRI with fat-saturating techniques such as short tau inversion recovery (STIR) to look for the presence of bone marrow edema. The Berlin modification of ASspiMRI-a (ASspiMRI-a) scoring technique assesses inflammation in each of the 23 disc vertebral units (DVU), capturing edema and erosion. Scores for each DVU range from 0-3 (0=normal; 1=minor bone marrow edema (less than25% of DVU; 3=severe bone marrow edema (more that 50% of DVU). The composite score ranges from 0 to 69, with higher scores indicating more severe inflammation|Baseline, week 6, week 28|Pharmacodynamic Analysis set: All patients with a least one evaluable post-treatment PD measurement and no major protocol deviations with impact on PD data were included. One subjects was excluded from the PD set in the AIN457 10mg/kg Part 1 due to protocol deviation||Score||Standard Deviation|Mean
781141|NCT00809159|Secondary|Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined|a Bayesian model was fitted to the ASAS20 , ASAS40 and ASAS 5/6 response rates on active and placebo treatments. A Bayesian analysis had been chosen to allow the direct incorporation into the analysis of information about placebo response rates from historical data|Day 8,15,29,week 6, 8, 10, 12, 16, 20, 24, 28|Pharmacodynamic Analysis set: All patients with a least one evaluable post-treatment PD measurement and no major protocol deviations with impact on PD data were included. One subjects was excluded from the PD set in the AIN457 10mg/kg Part 2 due to the absence of available post-baseline PD measurements||Participants|||Number
781142|NCT00809159|Secondary|Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1|ASAS20 responder had improvement of 40% or more and absolute improvement of at least 2 units (scale of 0 [least] to 10 [worst]) from Baseline in at least 3 of the following 4 domains, with no deterioration in the potential remaining domain: Patient's Global Assessment of Disease Activity; Total Back Pain visual analog scale (VAS); Function (Bath Ankylosing Spondylitis Functional Index (BASFI)); and Inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores). ASAS 5/6 responder had improvement of 20% or more) from Baseline in at least 5 of the following 6 domains: Patient's Global Assessment of Disease Activity; Total Back Pain visual analog scale (VAS); Function (Bath Ankylosing Spondylitis Functional Index (BASFI)); and Inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores); Spinal Mobility (BASFI); Acute phase reactant (CRP)|Day8,15,29,week 6, 8, 10, 12, 16, 20, 24, 28|Pharmacodynamic Analysis set: All patients with a least one evaluable post-treatment PD measurement and no major protocol deviations with impact on PD data were included. One subjects was excluded from the PD set in the AIN457 10mg/kg Part 1 due to protocol deviation||Participants|||Number
781143|NCT00809159|Primary|Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score From Baseline to 6 Weeks After First Infusion in Part 2|ASAS20 as described in Primary Outcome. ASAS40 responder had improvement of 40% or more and absolute improvement of at least 2 units (on a scale of 0 [least] to 10 [worst]) from Baseline in at least 3 of the following 4 domains, with no deterioration in the potential remaining domain: Patient's Global Assessment of Disease Activity; Total Back Pain visual analog scale (VAS); Function (Bath Ankylosing Spondylitis Functional Index (BASFI)); and Inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores). ASAS 5/6 responder had improvement of 20% or more) from Baseline in at least 5 of the following 6 domains: Patient's Global Assessment of Disease Activity; Total Back Pain visual analog scale (VAS); Function (BASFI); and Inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores); Spinal Mobility (BASFI); Acute phase reactant (CRP)|6 Weeks|Pharmacodynamic Analysis set: All patients with a least one evaluable post-treatment PD measurement and no major protocol deviations with impact on PD data were included. One subjects was excluded from the PD set in the AIN457 10mg/kg Part 2 due to the absence of available post-baseline PD measurements||Units on a scale||95% Confidence Interval|Least Squares Mean
781144|NCT00809159|Primary|Percentage of Participants Who Achieved ASAS20 Response|Clinical response to treatment was assessed according to ASAS20 criteria. ASAS20 responder had improvement of 20% or more and absolute improvement of at least 1 units (on a scale of 0 [least] to 10 [worst]) from Baseline in at least 3 of the following 4 domains, with absence of deterioration (worsening of at least 20% an absolute Worsening of at least 1 unit) in the potential remaining domain: Patient's Global Assessment of Disease Activity; Total Back Pain visual analog scale (VAS); Function (Bath Ankylosing Spondylitis Functional Index (BASFI)); and Inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores|6 Weeks|Pharmacodynamic Analysis set: All patients with a least one evaluable post-treatment PD measurement and no major protocol deviations with impact on PD data were included. One subjects was excluded from the PD set in the AIN457 10mg/kg Part 1 due to protocol deviation||Percentage|||Number
781145|NCT00809185|Secondary|Bone Marrow Morphology and Cytogenetics Pre- and Post-therapy||at 2 years of treatment||||||
781146|NCT00809185|Secondary|Laboratory Correlates (Cytotoxic T-cell Populations, S6K1 Levels, GSTT-1 Mutations, and Presence or Absence of HLA-DR15)||at 2 years of treatment||||||
781147|NCT00809185|Secondary|Dose- and Non-dose-limiting Toxicities||at end of one cycle (28 days)||||||
781148|NCT00809185|Primary|Number of Patients With Either a Major or Minor Erythroid Response(Hemoglobin Change From Baseline Measure)|"Major erythroid response: (1) For patients with a baseline hemoglobin less than 11 g/dL, a major erythroid response is defined as a > 2 g/dL increase in hemoglobin from baseline; or (2) 100% decrease in red blood cell transfusion requirements.
Minor erythroid response: (1) For patients with baseline hemoglobin less than 11 g/dL, a minor erythroid response is defined as an increase in hemoglobin greater than 1 g/dL but less than 2 g/dL from baseline; or (2) > 50% decrease in red blood cell transfusion requirements."|2 years of treatment|All patients enrolled were analyzed.||participants|||Number
781149|NCT00809276|Primary|To Determine the Optimal Regimen of Post-graft Immunosuppression With High-dose Cy Following Fludarabine, Busulfan, and Transplantation of Fully HLA-matched Bone Marrow That Leads to an Acceptable Incidence of Grades III/IV Acute GVHD|Percentage of participants with grade III-IV acute graft versus host disease (GVHD). GVHD is graded on a combination of skin symptoms (rash), gut symptoms (diarrhea), and liver symptoms (using a lab test called bilirubin). Grades range from I to IV, where I is the least severe and IV is the most severe.|1 year|||percentage of participants||95% Confidence Interval|Number
781417|NCT00794547|Secondary|To Assess Pharmacokinetics (PK) of Intravenous (IV) Calcitriol in Combination With Cisplatin and Docetaxel During Cycle 1 of the Phase II Part of the Study Using a Validated Limited Sampling Technique.||3-6 months||||||
781150|NCT00809328|Secondary|Eradication Rate (Bacteriological Response, Investigator Assessment)|"Eradication Rate was calculated from the following formula, the number of participants assessed as eradication , presumed eradication or microbial substitution over total participants excluding ones assessed as indeterminate multiplied by 100"|Day 3, End of Treatment, Day 15 and Day 29|"Bacteriologic per protocol set consisted of all subjects in the clinical per protocol set in whom bacterial pathogens were identified at baseline. No imputation was used for missing data. n  in the measured values was the total participants EXCLUDING ones assessed as indeterminate."||percentageof participants||95% Confidence Interval|Number
781151|NCT00809328|Secondary|Eradication Rate (Bacteriological Response, Data Review Committee Assessment)|"Eradication Rate was calculated from the following formula, the number of participants assessed as eradication , presumed eradication or microbial substitution over total participants excluding ones assessed as indeterminate multiplied by 100"|Day 3, End of Treatment, Day 15 and Day 29|"Bacteriologic per protocol set consisted of all subjects in the clinical per protocol set in whom bacterial pathogens were identified at baseline. No imputation was used for missing data. n  in the measured values was the total participants EXCLUDING ones assessed as indeterminate."||percentage of participants||95% Confidence Interval|Number
781152|NCT00809328|Secondary|The Tendency Toward Clinical Improvement (Investigator Assessment)|The number of participants who showed tendency toward clinical improvement based on the assessment of temperature, white blood cell count, C-reactive protein, clinical symptoms on Day 3, and was determined to continue the treatment.|Day 3|Clinical per protocol set consisted of all subjects who received at least one dose of the study drug, have no significant violation of protocol, and underwent prescribed evaluations during the observation period. No imputation was used for missing data.||participants|||Number
781153|NCT00809328|Secondary|Response Rate (Clinical Response, Investigator Assessment)|"Response rate was calculated from the following formula, the number of participants assessed as effective over total participants excluding ones assessed as indeterminate multiplied by 100"|End of Treatment, Day 15 and Day 29|"Clinical per protocol set consisted of all subjects who received at least one dose of the study drug, have no significant violation of protocol, and underwent prescribed evaluations during the observation period. No imputation was used for missing data. n  in the measured values means total participants excluding ones assessed as indeterminate."||percentage of participants||95% Confidence Interval|Number
781154|NCT00809328|Primary|Response Rate (Clinical Response, Data Review Committee Assessment)|"Response rate was calculated from the following formula, the number of participants assessed as effective over total participants excluding ones assessed as indeterminate multiplied by 100."|End of Treatment, Day 15 and Day 29|"Clinical per protocol set consisted of all subjects who received at least one dose of the study drug, have no significant violation of protocol, and underwent prescribed evaluations during the observation period. No imputation was used for missing data. n  in the measured values means total participants excluding ones assessed as indeterminate."||percentage of participants||95% Confidence Interval|Number
781155|NCT00809445|Secondary|Self-Report of Ever Having Been Tested|The HIV testing secondary outcomes are all binary (Yes/No). The below data represents self-reported completion of HIV test by 1 month.|1 month post-randomization|Number reporting having taken an HIV test, whether they received results or not, at one month follow-up. Note that 3, 5, and 6 participants who completed a one-month follow-up did not provide this self-report in HIV testing referral, HIV rapid test and counseling, and HIV rapid test and info, respectively||participants|||Number
781156|NCT00809445|Secondary|Sharing of Needles Used in Drug Use|Change in sharing of needles. The number of individuals reporting needle sharing at baseline and 6-month follow-up were measured and the change in sharing of needles assessed.|Six months|||n of people changing needle sharing|||Number
781157|NCT00809445|Primary|Number of Risky Sexual Behaviors|The sexual risk behavior primary outcome is self-reported sexual risk behavior, which will be measured at baseline and six months post-randomization as the self-reported number of unprotected sex acts (vaginal or anal sex without a condom).|Six months post-randomization|All randomized participants who provided self-report of number of unprotected sex acts (vaginal or anal sex without a condom) at six-month follow-up are included.||number of unprotected sex acts||Standard Deviation|Mean
781158|NCT00809445|Primary|Self-Report Receipt of HIV Test Results|The HIV testing primary outcome is self-reported receipt of HIV test results. This will be measured at one month post-randomization for all participants. We recognize that there are three potential HIV testing behaviors that could be evaluated in this study: acceptance of HIV testing, completion of HIV testing, and receipt of HIV testing results. Acceptance of testing refers to whether or not a participant would accept the offer of an HIV test. Completion of testing refers to whether or not a participant completes the HIV test. Receipt of HIV test results refers to whether or not a participant self-reports having received the results of the HIV test.|One month post-randomization|All randomized participants who provided self-report of either receipt or non-receipt of testing results at one month follow-up are included. Note that 3, 5, and 6 participants who completed a one-month follow-up did not provide this self-report in HIV testing referral, HIV rapid test and counseling, and HIV rapid test and info, respectively||participants|||Number
781159|NCT00809458|Secondary|Determine Concordance of the Biomarkers in This Setting|The correlation between the ATQ level and the androgen receptor will be explored.|3 years|This study was terminated early due to low accrual. No participants were analyzed for this outcome measure because the study was terminated. There are no data to report.|||||
781160|NCT00809458|Secondary|Determine the Tolerability/Toxicity of a Short Course of Vitamin E in the Neoadjuvant Setting.|"Cardiovascular Effects/ Thrombophlebitis
Dermatologic Effects
Gastrointestinal Effects (Gingival bleeding, and gastrointestinal irritations including: diarrhea, nausea, flatulence and stomach cramps)
Hematologic Effects (Increased bleeding tendencies in vitamin K deficient patients; inhibition of prothrombin production
Hepatic Effects (Vasculopathic hepatotoxicity and cholestasis)
Neurologic Effects (Dizziness, headache, fatigue or weakness
Ophthalmic Effects ( Blurred vision)
Respiratory Effects (Pulmonary embolism)"|3 years|This study was terminated early due to low accrual. No participants were analyzed for this outcome measure because the study was terminated. There are no data to report.|||||
781200|NCT00809757|Secondary|Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 2|Peak expiratory flow (PEF) measures how fast a person can breathe out using the greatest effort|Baseline, Visit 2: 30 minutes post-dose (on the day of randomization), 1 hour post-dose, 4 hours post-dose, 6 hours post-dose|Intent-to-Treat Population – PEF Cohort (Subjects able to perform PEFs)||liters||Standard Deviation|Mean
781161|NCT00809458|Primary|Reduce Biomarkers of Prostate Cancer (PSA Blood Level)|PSA levels will be measured as a sensitive marker of anti-androgenic activity that is a critical endpoint to be measured in this study. PSA blood levels will be determined at the initiation and completion of Vitamin E supplementation from blood obtained at these time points. A clinical reference laboratory will perform blood PSA analysis and will be compared with plasma cholesterol levels as a relative control.|30 days|This study was terminated early due to low accrual. No participants were analyzed for this outcome measure because the study was terminated. There are no data to report.|||||
781162|NCT00809471|Primary|Change in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Score|Questionnaire assesses subject's evaluation of erectile function over the previous 4-week period. Total score from questions 1-5 & 15 ranges from 1 to 30. A higher score indicates better erectile function.|Baseline, End of Treatment (up to 12 weeks)|Number of participants analyzed represents the Intent-to-Treat population. For dropouts or missing data, the last observation carried forward convention was used.||scores on a scale||Standard Deviation|Least Squares Mean
781163|NCT00809471|Primary|Change in Percentage of Sexual Attempts in Which Subjects Were Able to Insert the Penis Into the Partner's Vagina|"Data presented as mean change from baseline in the percentage of Yes responses to Sexual Encounter Profile (SEP) diary question 2 Were you able to insert your penis into your partner's vagina?"|Baseline, 12 Weeks|Number of participants analyzed represents the Intent-to-Treat population.||percentage of sexual attempts||Standard Error|Least Squares Mean
781164|NCT00809471|Primary|Change in Percentage of Sexual Attempts in Which Subjects Were Able to Maintain an Erection of Sufficient Duration to Have Successful Intercourse|"Data presented as mean change from baseline in the percentage of Yes responses to Sexual Encounter Profile (SEP) diary question 3 Did your erection last long enough for you to have successful intercourse?"|Baseline, 12-weeks|Number of participants analyzed represents the Intent-to-Treat population.||percentage of sexual attempts||Standard Error|Least Squares Mean
781165|NCT00809523|Primary|Percentage Change SIGH SAD Depression Rating|"SIGH SAD Structured Interview Guide for the Hamilton Depression Rating Scale, Seasonal Affective Disorder (SAD)version. The items are augmented with additional items to reflect better the atypical depressive symptoms usually seen in SAD, eg, increased sleep, weight, appetite and fatigue. On this scale, higher scores reflect increased depression intensity. The maximum score attainable is 63, and the minimum is 0. A score of less than 9 is regarded as consistent with normal mood, the absence of major depression.
Calculated: SIGH SAD score at trial end – SIGH SAD score at randomization x 100 / SIGH SAD score at randomization"|4 weeks|Intent to treat analysis last observation carried forward.||percentage of change on SIGH SAD||Standard Deviation|Mean
781166|NCT00809523|Secondary|Clinical Global Impression of Severity|The Clinical Global Impression of Severity is a 7-point scale in which the clinician gives an overall impression of depression severity, with the following anchor points: (1)Normal, not at all ill, (2)Borderline ill, (3) Mildly ill, (4)Moderately ill, (5) Markedly ill, (6)Severely ill, and (7)Among the most severely ill patients. The minimum is therefore 1 and the maximum is 7, which represents very severe depression.|Randomization and at 4 weeks|intent to treat analysis||units on a scale||Standard Deviation|Mean
781167|NCT00809523|Secondary|SIGH SAD Depression Rating|SIGH SAD Structured Interview Guide for the Hamilton Depression Rating Scale, Seasonal Affective Disorder (SAD)version. This is a structured interview, which is an interview in which the clinician is provided exact questions to use to inquire about symptoms of depression and explicit standards for rating the intensity of each symptom item. The interview assesses the symptoms which make up the Hamilton Depression Rating Scale, which is the standard in the majority of clinical trials in depression. The items are augmented with additional items to reflect better the atypical depressive symptoms usually seen in SAD, eg, increased sleep, weight, appetite and fatigue. On this scale, higher scores reflect increased depression intensity. The maximum score attainable is 63, and the minimum is 0. A score of less than 9 is regarded as consistent with normal mood, the absence of major depression.|Weekly|Intent to treat analysis last observation carried forward.||units on a scale||Standard Deviation|Mean
781168|NCT00809614|Secondary|Pharmacokinetic (PK) of AIN457: Volume of Distribution During the Terminal Phase Following Intravenous Elimination (Vz)|On dosing days (Day 1 and Day 22) samples were taken at pre-dose (0 h), 2, 3, 4, 24. After the first infusion samples were taken at Day 8 and Day 15. After the second infusion samples were taken at Day 29, Day 43, Day 57, Day 71, Day 85, Day 113, Day 141, Day 169.|Day 1 till end of the study (169)|Only patients who recieved active drug with evaluable pharmacokinetic (PK) parameter data and no protocol deviation that impacted PK were included in the PK data analysis set||Liters||Standard Deviation|Mean
781169|NCT00809614|Secondary|PK of AIN457: Area Under the Serum Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast), Area Under the Serum Concentration-time Curve From Time Zero to (AUCinf)|On dosing days (Day 1 and Day 22) samples were taken at pre-dose (0 h), 2, 3, 4, 24. After the first infusion samples were taken at Day 8 and Day 15. After the second infusion samples were taken at Day 29, Day 43, Day 57, Day 71, Day 85, Day 113, Day 141, Day 169.|Day 1 till end of the study (169)|Only patients who recieved active drug with evaluable pharmacokinetic (PK) parameter data and no protocol deviation that impacted PK were included in the PK data analysis set||day*ug/mL||Standard Deviation|Mean
781170|NCT00809614|Secondary|Pharmacokinetic (PK) of AIN457: Observed Maximum Serum Concentration Following Drug Administration (Cmax)|On dosing days (Day 1 and Day 22) samples were taken at pre-dose (0 h), 2, 3, 4, 24. After the first infusion samples were taken at Day 8 and Day 15. After the second infusion samples were taken at Day 29, Day 43, Day 57, Day 71, Day 85, Day 113, Day 141, Day 169.|Day 1 till end of the study (169)|Only patients who recieved active drug with evaluable pharmacokinetic (PK) parameter data and no protocol deviation that impacted PK were included in the PK data analysis set||ug/mL||Standard Deviation|Mean
781171|NCT00809614|Secondary|Pharmacokinetic (PK) of AIN457: Terminal Elimination Half-life (T1/2)|On dosing days (Day 1 and Day 22) samples were taken at pre-dose (0 h), 2, 3, 4, 24. After the first infusion samples were taken at Day 8 and Day 15. After the second infusion samples were taken at Day 29, Day 43, Day 57, Day 71, Day 85, Day 113, Day 141, Day 169.|Day 1 till end of the study (169)|Only patients who recieved active drug with evaluable pharmacokinetic (PK) parameter data and no protocol deviation that impacted PK were included in the PK data analysis set||day||Standard Deviation|Mean
781845|NCT00799396|Primary|Changes in Platelet Function in Response to Clopidogrel|Baseline minus post clopidogrel/pre-aspirin platelet rich plasma (PRP) maximum aggregation.|Measured at baseline, and after clopidogrel treatment|||percentage of maximum aggregation change||Standard Deviation|Mean
781172|NCT00809614|Secondary|Pharmacokinetic (PK) of AIN457: Clearance of AIN457 After Single Dose Administration|On dosing days (Day 1 and Day 22) samples were taken at pre-dose (0 h), 2, 3, 4, 24. After the first infusion samples were taken at Day 8 and Day 15. After the second infusion samples were taken at Day 29, Day 43, Day 57, Day 71, Day 85, Day 113, Day 141, Day 169.|Day 1 till end of the study (169)|Only patients who recieved active drug with evaluable pharmacokinetic (PK) parameter data and no protocol deviation that impacted PK were included in the PK data analysis set||Liters/day||Standard Deviation|Mean
781173|NCT00809614|Secondary|Pharmacokinetic (PK) of AIN457: Time to Reach the Maximum Concentration After Drug Administration (Tmax)|On dosing days (Day 1 and Day 22) samples were taken at pre-dose (0 h), 2, 3, 4, 24. After the first infusion samples were taken at Day 8 and Day 15. After the second infusion samples were taken at Day 29, Day 43, Day 57, Day 71, Day 85, Day 113, Day 141, Day 169.|Day 1 till end of the study (169)|Only patients who recieved active drug with evaluable pharmacokinetic ( PK) parameter data and no protocol deviation that impacted PK were included in the PK data analysis set||Day||Full Range|Median
781174|NCT00809614|Secondary|Disease Activity Score 28 (DA28) in Patients Over Time Per Treatment|The Disease Activity Score (DAS) is a combined index to measure disease activity in arthritic patients. DAS28 is determined using the following variables: 28-joint counts (tender28 and swollen28), CRP, and the participant's general health (GH) Based on the patients global disease activity measured on a Visual Analogue Scale (VAS) of 100 mm (0 - 100). Using the data from these variables, DAS28 is calculated using the following formula: DAS28 = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014*GH + 0.96. The calculation results in a DAS28 score from 0 to 10 indicating the current activity of the rheumatoid arthritis of the patient. A DAS28 above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity. Remission is achieved by a DAS28 lower than 2.6.|Baseline, day 8, 15 and weeks 6, 8, 12, 16 and 24|For pharmacodynamic (PD) analysis set five patients were excluded due to protocol deviations||Units on a scale||Standard Deviation|Mean
781175|NCT00809614|Secondary|Leeds Dactylitis Instrument (LDI) Score in Patients Over Time Per Treatment|The LDI basic measured the ratio of the circumference of the affected digit to the circumference of the digit on the opposite hand or foot, using a minimum difference of 10% to define a dactylitic digit. The ratio of circumference was multiplied by a tenderness score, using a modification of LDI which was a binary score (1 for tender, 0 for non-tender). If both sides were considered involved, the number was compared to data provided in a table. This modification was referred to as LDI basic and was applied in this study. The LDI required a tool to measure digital circumference and this tool was provided to the centers.|Baseline, Day 8, 15 and weeks 6, 8, 12, 16 and 24|Only participants from the pharmacodynamic (PD) analysis set, who had available scores at each given time point, were analyzed for that time point. The PD analysis set included all patients with evaluable PD data with no protocol deviations that impacted PD data analysis.||total score||Standard Deviation|Mean
781176|NCT00809614|Secondary|SpA Research Consortium of Canada (SPARCC) Score Score in Patients Over Time Per Treatment|SPARCC evaluated 18 enthesis sites: medial and lateral epicondyle humerus, supraspinatus insertion, proximal Achilles, greater trochanter, medial and lateral condyl femur, insertion of plantar fascia, quadriceps insertion of patella, inferior pole of patella, and tibial tubercle. SPARCC enthesis index is defined as the total number of painful entheses assessed at the SPARCC sites. Total SI joint scores could range from 0 to 78, with a higher score indicating more signs of disease.|Baseline, Day 8, 15 and weeks 6, 8, 12, 16 and 24|For pharmacodynamic (PD) analysis set five patients were excluded due to protocol deviations||Unit on a scale||Standard Deviation|Mean
781177|NCT00809614|Secondary|Psoriatic Area and Severity Index (PASI) Score in Patients Over Time Per Treatment|The PASI assessed the extent of psoriasis on four body surface areas (head, trunk and upper and lower limbs) and the degree of plaque erythema, scaling and thickness. The PASI score accounted for the extent of body surface area affected by the erythema, scaling and thickness, and the severity of these measures. The score ranged from 0 (no disease) to 72 (maximal disease).|Baseline, Day 8, 15 and weeks 6, 8, 12, 16, 20 and 24|For pharmacodynamic (PD) analysis set five patients were excluded due to protocol deviations||Unit on a Scale||Standard Deviation|Mean
781178|NCT00809614|Secondary|Mastricht Ankylosing Spondylitis Enthesis Score (MASES) Over Time Per Treatment|The MASES included assessments of 13 sites. Enthesitis sites included in the MASES index are: 1st costochondral, 7th costochondral, posterior superior iliac spine, anterior superior iliac spine, iliac crest (all above was assessed bilaterally), 5th lumbar spinous process, proximal Achilles (bilateral). The MASES score is defined as the total number of painful MASES entheses. The score was derived as the sum of the 13 scores divided by 3 and the total range is 0 (no tenderness) to 13 (severe tenderness).|Baseline and Day 8, 15 and weeks 6, 8, 12, 16 and 24|For pharmacodynamic (PD) analysis set five patients were excluded due to protocol deviations||Units on a scale||Standard Deviation|Mean
781179|NCT00809614|Secondary|Percentage of Participants Who Achieved PsARC Response|"responder defined as 20% or more improvement in at least 4 of 6 criteria: 1) swollen joint count, 2) tender joint count, 3) morning stiffness duration (low back), 4) current low back pain, 5) current peripheral joint pain, 6) patient global assessment A subject is defined as a PsARC responder if, and only if, they have an improvement in two of the following four factors (with at least one factor being a joint count) and no worsening in the remaining factors: 1) Patient global assessment (0-100 VAS scale, improvement defined as decrease of at least 20 units) 2) Physician global assessment (0-100 VAS scale, improvement defined as decrease of at least 20 units) 3) Tender 78-joint count (improvement defined as decrease of at least 30%) 4) Swollen 76-joint count (improvement defined as decrease of at least 30%)"|Day 8 and 15, Weeks 6, 8, 12, 16 and 24|For pharmacodynamic (PD) analysis set five patients were excluded due to protocol deviations.||Percentage of participants|||Number
781180|NCT00809614|Secondary|Percentage of Participants Who Achieved 20%, 50% or 70% Improvement as Measured by ACR Response Criteria|A participant was considered to be a responder according to the ACR20, 50 or 70 criteria if the participant had at least 20% 50% or 70% improvement in both the tender joint count and swollen joint count measures, and in at least 3 of the following 5 measures: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score, and/or C-reactive protein (CRP)|Day 8 and 15, Weeks 6, 8, 12, 16 and 24|For pharmacodynamic (PD) analysis set five patients were excluded due to protocoldeviations.||Percentage of particpants|||Number
781181|NCT00809614|Primary|Percentage of PsARC Responders Per Treatment at Week 6|"Psoriatic Arthritis Response Criteria (PsARC) includes measures of tender and swollen joint counts, patient's assessment of pain, physician's and patient's global assessment of disease activity
A subject is defined as a PsARC responder if, and only if, they have an improvement in two of the following four factors (with at least one factor being a joint count) and no worsening in the remaining factors: 1) Patient global assessment (0-100 VAS scale, improvement defined as decrease of at least 20 units) 2) Physician global assessment (0-100 VAS scale, improvement defined as decrease of at least 20 units) 3) Tender 78-joint count (improvement defined as decrease of at least 30%) 4) Swollen 76-joint count (improvement defined as decrease of at least 30%)"|week 6|For pharmacodynamic (PD) analysis set five patients were excluded due to protocol deviations.||Percentage of PsARC responders|||Number
781182|NCT00809614|Primary|Percentage of ACR Responders Per Treatment at Week 6|A participant was considered to be a responder according to the ACR20, 50 or 70 criteria if the participant had at least 20% 50% or 70% improvement in both the tender joint count and swollen joint count measures, and in at least 3 of the following 5 measures: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score, and/or C-reactive protein (CRP)|week 6|For pharmacodynamic (PD) analysis set five patients were excluded due to protocol deviations.||Percentage of ACR responders|||Number
781183|NCT00809757|Secondary|Change From Baseline to Visit 3 and Visit 4 in the Pediatric Asthma Caregiver’s Quality of Life Questionnaire (PACQLA) Composite Score|The PACQLQ composite score was calculated as the mean of the scores of the 13 individual questions. Composite scores could range from 1 to 7. Lower scores indicated greater impact of disease on quality of life.|Visit 3 and Visit 4 (End of 28 day treatment period)|Intent-to-Treat Population||Units on a scale||Standard Deviation|Mean
781184|NCT00809757|Secondary|Rescue Medication Use – Change From Baseline in Mean Number of Doses Used Per Week During Weeks When Used||Visit 2 to Visit 3 (the first 2 weeks of the study), Visit 3 to Visit 4 (the second 2 weeks of the study), Visit 2 to Visit 4 (the entire 4 weeks of the study)|Intent-to-Treat Population – subjects who used rescue medication at any time during the first 2 weeks of the study and who had used rescue medication at any time during baseline||Doses per Week||Standard Deviation|Mean
781185|NCT00809757|Secondary|Rescue Medication Use – Change From Baseline in Mean Number of Doses Used Per Week||Visit 2 to Visit 3 (the first 2 weeks of the study) , Visit 3 to Visit 4 (the second 2 weeks of the study), Visit 2 to Visit 4 (the entire 4 weeks of the study)|Intent-to-Treat Population||Doses per Week||Standard Deviation|Mean
781186|NCT00809757|Secondary|Rescue Medication Use – Change From Baseline in Mean Number of Days Used Per Week When Used||Visit 2 to Visit 3 (the first 2 weeks of the study) , Visit 3 to Visit 4 (the second 2 weeks of the study), Visit 2 to Visit 4 (the entire 4 weeks of the study)|Intent-to-Treat Population – Subjects who used rescue medication at any time during the first two weeks of the study and who used rescue medication at any time during baseline||Days per Week||Standard Deviation|Mean
781187|NCT00809757|Secondary|Rescue Medication Use: Number of Subjects Using Rescue Medication During the Treatment Period|Number of subjects using rescue medication during the treatment period|Visit 2 to Visit 3 (the first 2 weeks of the study) , Visit 3 to Visit 4 (the second 2 weeks of the study), Visit 2 to Visit 4 (the entire 4 weeks of the study)|Intent-to-Treat Population||Number of subjects|||Number
781188|NCT00809757|Secondary|Caregiver Global Assessment – Question 3|Overall I was: Very satisfied with the control of the child's asthma symptoms while enrolled in this study, Moderately satisfied with the control of the child's asthma symptoms while enrolled in this study, Slightly satisfied with the control of the child's asthma symptoms while enrolled in this study, Not satisfied with the control of the child's asthma symptoms while enrolled in this study or answer Missing|Visit 4 (End of 28 day treatment period)|Intent-to-Treat Population||Number of subjects|||Number
781189|NCT00809757|Secondary|Caregiver Global Assessment – Question 2|Since the start of the study, how would you evaluate your ability to manage your child’s asthma?|Visit 4 (End of 28 day treatment period)|Intent-to-Treat Population||Number of subjects|||Number
781190|NCT00809757|Secondary|Caregiver Global Assessment – Question 1|Since the start of the study, how would you evaluate your child’s asthma symptoms?|Visit 4 (End of 28 day treatment period)|Intent-to-Treat Population||Number of subjects|||Number
781191|NCT00809757|Secondary|Investigator Global Assessment – Question 2|Since the start of the study, how would you evaluate your ability to manage the subject’s asthma?|Visit 4 (End of 28 day treatment period)|Intent-to-Treat Population||Number of subjects|||Number
781192|NCT00809757|Secondary|Investigator Global Assessment – Question 1|Since the start of the study, how would you evaluate the child’s asthma symptoms?|Visit 4 (End of 28 day treatment period)|Intent-to-Treat Population||Number of subjects|||Number
781193|NCT00809757|Secondary|Percent Change From Baseline in the At-Home Mean Daily Peak Expiratory Flow (PEF to Postdose Timepoint at Visit 3 and Visit 4)|Mean of the daily pre-dose PEF values in the week prior to visit in those subjects aged 24 to <48 months capable of performing acceptable and reproducible PEF maneuvers.|Visit 3 (the week prior to Visit 3), Visit 4 (the week prior to Visit 4)|Intent-to-Treat Population – PEF Cohort (Subjects able to perform PEFs)||percent change||Standard Deviation|Mean
781194|NCT00809757|Secondary|Change From Baseline in the At-Home Mean Daily Peak Expiratory Flow (PEF to Postdose Timepoint at Visit 3 and Visit 4|Mean of the daily pre-dose PEF values in the week prior to visit in those subjects aged 24 to <48 months capable of performing acceptable and reproducible PEF maneuvers.|Baseline, Visit 3 (the week prior to Visit 3) and Visit 4|Intent-to-Treat Population – PEF Cohort (Subjects able to perform PEFs)||liters||Standard Deviation|Mean
781195|NCT00809757|Secondary|Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 4||Baseline, Visit 4, pre –dose (approximately 28 days after randomization)|Intent-to-Treat Population – PEF Cohort (Subjects able to perform PEFs)||percent change||Standard Deviation|Mean
781196|NCT00809757|Secondary|Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 3||Baseline, Visit 3, pre –dose (approximately 14 days after randomization)|Intent-to-Treat Population – PEF Cohort (Subjects able to perform PEFs)||percent change||Standard Deviation|Mean
781197|NCT00809757|Secondary|Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 2||Baseline, Visit 2: , 30 minutes post-dose (on the day of randomization), 1 hour post-dose, 4 hours post-dose, 6 hours post-dose|Intent-to-Treat Population – PEF Cohort (Subjects able to perform PEFs)||percent change||Standard Deviation|Mean
781201|NCT00809757|Secondary|Change From Baseline to Visit 3 to Visit 4 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Score as Measured by the Pediatric Asthma Questionnaire|"The daily composite score is the sum of the scores of 7 items: Difficulty Breathing, Cough, Wheeze, Activity Limitation, Level of Activity Limitation, Overall Symptom Score, and Nighttime Asthma. The range for the PAQ is 0 (no symptoms) to 27 (severe symptoms).
The mean daily composite score from Visit 3 to Visit 4 is defined as the mean of the daily composite scores from Visit 3 (inclusive) to the day prior to Visit 4."|The days from Visit 3 (inclusive) to the day prior to Visit 4 – approximately 14 days|Intent-to-Treat Population||units on a scale||Standard Deviation|Mean
781202|NCT00809757|Secondary|Change From Baseline to Visit 2 to Visit 3 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Scores as Measured by the Pediatric Asthma Questionnaire|"The daily composite score is the sum of the scores of 7 items: Difficulty Breathing, Cough, Wheeze, Activity Limitation, Level of Activity Limitation, Overall Symptom Score, and Nighttime Asthma. The range for the PAQ is 0 (no symptoms) to 27 (severe symptoms).
The mean daily composite score from Visit 2 to Visit 3 is defined as the mean of the daily composite scores from Visit 2 (inclusive) to the day prior to Visit 3."|The days from Visit 2 (inclusive) to the day prior to Visit 3 – approximately 14 days|Intent-to-Treat Population||units on a scale||Standard Deviation|Mean
781203|NCT00809757|Secondary|Change From Baseline to Visit 4 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Scores as Measured by Pediatric Asthma Questionnaire|"The daily composite score is the sum of the scores of 7 items: Difficulty Breathing, Cough, Wheeze, Activity Limitation, Level of Activity Limitation, Overall Symptom Score, and Nighttime Asthma. The range for the PAQ is 0 (no symptoms) to 27 (severe symptoms).
The mean daily composite score at Visit 4 is defined as the mean daily composite scores in the 7 days prior to Visit 4."|Baseline, Visit 4 (Week 4)|Intent-to-Treat Population||units on a scale||Standard Deviation|Mean
781204|NCT00809757|Secondary|Change From Baseline to Visit 3 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Scores as Measured by the Pediatric Asthma Questionnaire (PAQ)|"The daily composite score is the sum of the scores of 7 items: Difficulty Breathing, Cough, Wheeze, Activity Limitation, Level of Activity Limitation, Overall Symptom Score, and Nighttime Asthma. The range for the PAQ is 0 (no symptoms) to 27 (severe symptoms).
The mean daily composite score at Visit 3 is defined as the mean daily composite scores for 7 days prior to Visit 3."|Baseline, Visit 3 (Week 3)|Intent-to-Treat Population||units on a scale||Standard Deviation|Mean
781205|NCT00809757|Secondary|Change From Baseline to Visit 3 to Visit 4 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment|"The daily composite score is the sum of the scores of 5 domains: Nocturnal Awakenings Due to Wheeze and Cough, Daytime Wheeze, Daytime Cough, Shortness of Breath, and Asthma Symptom Score. A possible score of 0 (no symptoms) to 19 (severe symptoms).
The mean daily composite score from Visit 3 to Visit 4 is defined as the mean of the daily composite scores from Visit 3 (inclusive) to the day prior to Visit 4."|The days from Visit 3 (inclusive) to the day prior to Visit 4 – approximately 14 days|Intent-to-Treat Population||units on a scale||Standard Deviation|Mean
781206|NCT00809757|Secondary|Change From Baseline to Visit 2 to Visit 3 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment|"The daily composite score is the sum of the scores of 5 domains: Nocturnal Awakenings Due to Wheeze and Cough, Daytime Wheeze, Daytime Cough, Shortness of Breath, and Asthma Symptom Score. A possible score of 0 (no symptoms) to 19 (severe symptoms).
The mean daily composite score from Visit 2 to Visit 3 is defined as the mean of the daily composite scores from Visit 2 (inclusive) to the day prior to Visit 3."|The days from Visit 2 (inclusive) to the day prior to Visit 3 – approximately 14 days|Intent-to-Treat Population||units on a scale||Standard Deviation|Mean
781207|NCT00809757|Secondary|Change From Baseline to Visit 3 in Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment|"The daily composite score is the sum of the scores of 5 domains: Nocturnal Awakenings Due to Wheeze and Cough, Daytime Wheeze, Daytime Cough, Shortness of Breath, and Asthma Symptom Score. A possible score of 0 (no symptoms) to 19 (severe symptoms).
The mean daily composite score at Visit 3 is defined as the mean of the daily composite scores in the 7 days prior to Visit 3."|Baseline, Visit 3 (Week 3)|Intent-to-Treat Population||units on a scale||Standard Deviation|Mean
781208|NCT00809757|Primary|Change From Baseline to Visit 4 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessments (PACA)|"The daily composite score is the sum of the scores of 5 domains: Nocturnal Awakenings Due to Wheeze and Cough, Daytime Wheeze, Daytime Cough, Shortness of Breath, and Asthma Symptom Score. A possible score of 0 (no symptoms) to 19 (severe symptoms).
The mean daily composite score at Visit 4 is defined as the mean of the daily composite scores in the week prior to Visit 4."|Baseline, Visit 4 (Week 4)|Intent-to-Treat Population. Only those subjects who had non-missing data at Week 4 and at Baseline were included. Subjects who discontinued from the study prior to Week 4 are not included in this analysis||units on a scale||Standard Deviation|Mean
781209|NCT00809809|Secondary|Compare Zicam to Placebo on the Incidence of, Speed of, and the Rate of Healing for Aborted Cold Sore Lesions.||14 days||||||
781210|NCT00809809|Primary|Zicam Was Compared to Placebo as a Treatment of Recurrent HSL From the Date and Time of the Initiation of Therapy Until the Date and Time of Resolution of the Lesion or After 14 Days of Treatment, Whichever Comes First.|Zinc gluconate swabs were compared as a treatment of recurrent HSL compared to placebo from the date and time of the initiation of therapy until the date and time of resolution of the lesion or after 14 days of treatment, whichever comes first.|14 days|5 subjects met exclusion criteria and were excluded from analysis. 2 subjects used concomitant medications and were excluded from the final analysis. Twelve subjects with recurrent HSL enrolled twice, only the 1st enrollment was included in the analysis. 2 subjects had family enroll who were excluded from analysis. Analysis - 134 subjects.||Days to resolution||95% Confidence Interval|Median
781211|NCT00809835|Secondary|Cognitive Function|"A composite using a carefully selected neuropsychological battery that includes measures of executive cognitive functioning frequently affected among cocaine users, likely to be important moderators of CBT4CBT, and sensitive to galantamine effects. These will include measures of multiple aspects of attention, cognitive inhibition, sustained attention (CANTAB), decision making (BART), and memory (digit span).
Scores ranged from -1.77 to 1.42 with a higher score indicating higher cognitive functioning."|12 weeks|All participants did not complete the CANTAB assessments at both pre and post treatment. Reasons for not completing were refusal to complete the tasks, inability to complete the tasks in a manner in which they could be scored and equipment or computer problems.||scores on a scale||Standard Deviation|Mean
781212|NCT00809835|Primary|Cocaine Abstinence|operationalized by percentage of drug-free urine specimens submitted (We will use the Branan ToxCup Drug Screen Cup onsite TESTCUP system for detection of cocaine, methamphetamine, THC, benzodiazepine, and opioids) at 12 Weeks|12 weeks|Three arm had one subject drop out before study medication was given- therefore the number analyzed are those that received first treatment.||percentage of negative urines||Standard Deviation|Mean
781213|NCT00809835|Primary|Cocaine Use|Reduction in cocaine use, operationalized as the frequency of cocaine use by month using timeline followback.|12 weeks|Presented are data for those measured at baseline and at 12 weeks. 2 individuals in the Galantamine arm were not measured at 12 weeks.||Days||Standard Deviation|Mean
781214|NCT00809848|Secondary|Percentage of Patients With ≥ 20% Reduction From Baseline in Diurnal IOP|IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP is the average of the IOP values of both eyes at each time point measured at protocol-specified times throughout the day.|Baseline, Day 14|Modified Intent to Treat: all randomized and treated patients who had at least a baseline visit and 1 postbaseline IOP evaluation||Percentage of Patients|||Number
781215|NCT00809848|Primary|Change From Baseline in Average Eye Intraocular Pressure (IOP)|IOP is a measurement of the fluid pressure inside the eye. The average of the 2 eyes is used for the analyses. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening).|Baseline, Day 14 Hour 0|Modified Intent to Treat: all randomized and treated patients who had at least a baseline visit and 1 postbaseline IOP evaluation||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
781216|NCT00809926|Other Pre-specified|Change From Baseline in Mean Ambulatory Diastolic Blood Pressure (MADBP)|To evaluate 24-hour ambulatory diastolic blood pressure measurements in a subset of patients after 8 weeks of treatment with the combination of valsartan and aliskiren versus valsartan monotherapy in patients with stage 2 hypertension.|Baseline to week 8|Patients who were willing to participate in the ABPM substudy and who met the study inclusion and exclusion criteria for randomization.||mm Hg||Standard Deviation|Mean
781217|NCT00809926|Other Pre-specified|Change From Baseline in Mean Ambulatory Systolic Blood Pressure (MASBP).|To evaluate 24-hour ambulatory systolic blood pressure measurements in a subset of patients after 8 weeks of treatment with the combination of valsartan and aliskiren versus valsartan monotherapy in patients with stage 2 hypertension.|Baseline to week 8|Patients who were willing to participate in the Ambulatory Blood Pressure Monitoring (ABPM) substudy and who met the study inclusion and exclusion criteria for randomization.||mm Hg||Standard Deviation|Mean
781218|NCT00809926|Other Pre-specified|Longitudinal Repeated Measure Analysis for Change in MSSBP From Baseline Through Week 8|To evaluate the change from baseline in MSSBP (mmHg) after 8 weeks; primary efficacy variable (ITT population) using Longitudinal analysis (A repeated measures analysis where assessments over time are considered , as opposed to looking at a single point in time.)|Baseline through week 8|The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study medication and had valid baseline and at least one valid post-baseline assessment of an efficacy variable.||mm Hg||Standard Error|Least Squares Mean
781219|NCT00809926|Other Pre-specified|Completers Analysis for Change From Baseline in MSSBP at Week 8|To evaluate the change from baseline in MSSBP (mmHg) at Week 8; primary efficacy variable at primary time point in ITT population – patients who completed the double-blind treatment period.|Baseline to week 8|The analysis included ITT patients who completed the double-blind treatment period [those patients with a final observation at week 8, also known as observed cases (OC)]. This analysis differed from the ITT-LOCF analysis, in that it did not include patients who discontinued from the trial prematurely.||mm Hg||Standard Deviation|Mean
781220|NCT00809926|Secondary|Mean Change From Baseline in Plasma Renin Concentration (PRC) at Week 8|To assess the change from baseline in PRC after 8 weeks of treatment with a valsartan and aliskiren treatment regimen (160/150 mg, 320/300 mg) versus a valsartan treatment regimen (160 mg, 320 mg) in patients with Stage 2 Hypertension.|Baseline to Week 8|The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study medication and had valid baseline and at least one valid post-baseline assessment of an efficacy variable.||ng/L||Standard Deviation|Mean
781221|NCT00809926|Secondary|Mean Change From Baseline in Plasma Renin Activity (PRA) at Week 8|To assess the change from baseline in PRA after 8 weeks of treatment with a valsartan and aliskiren treatment regimen (160/150 mg, 320/300 mg) versus a valsartan treatment regimen (160 mg, 320 mg) in patients with Stage 2 Hypertension.|Baseline to Week 8|The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study medication and had valid baseline and at least one valid post-baseline assessment of an efficacy variable.||ng/mL/h||Standard Deviation|Mean
781222|NCT00809926|Secondary|Percentage of Responders (Defined as Patients With MSSBP <140 mmHg or a Decrease From Baseline ≥20 mmHg) at Week 8|To compare the percentage of responders (defined as patients with MSSBP <140 mmHg or a decrease from baseline ≥20 mmHg) at week 8 following treatment with a valsartan and aliskiren treatment regimen (160/150 mg, 320/300 mg) versus a valsartan treatment regimen (160 mg, 320 mg) in patients with Stage 2 Hypertension.|At Week 8|The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study medication and had valid baseline and at least one valid post-baseline assessment of an efficacy variable.||percentage of responders|||Number
781223|NCT00809926|Secondary|Percentage of Patients Achieving Blood Pressure Control (Defined as Patients Achieving a MSSBP <140 mmHg and MSDBP <90 mmHg) at Week 8|To evaluate the percentage of patients achieving blood pressure control (defined as patients achieving a MSSBP <140 mmHg and MSDBP <90 mmHg) at week 8 following treatment with a valsartan and aliskiren treatment regimen (160/150 mg, 320/300 mg) versus a valsartan treatment regimen (160 mg, 320 mg) in patients with Stage 2 Hypertension.|At Week 8|The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study medication and had valid baseline and at least one valid post-baseline assessment of an efficacy variable.||percentage of patients|||Number
781262|NCT00810108|Primary|Lopinavir Area Under the Curve (AUC)|Lopinavir Area Under the Plasma Concentration versus Time Curve (AUC)|pre-dose, 1,2,4,6,8, and 12 hours post-dose|All subjects who completed the pharmacokinetic sampling visits with whole tablet administration were analyzed||mg*hr/L||Inter-Quartile Range|Median
781224|NCT00809926|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8|To compare the change in MSDBP after 8 weeks of treatment with a valsartan and aliskiren treatment regimen (160/150 mg, 320/300 mg) versus a valsartan (160 mg, 320 mg) treatment regimen in patients with Stage 2 Hypertension.|Baseline to Week 8|Intent-to-treat (ITT) population consisted of all randomized patients who received at least 1 dose of study drug and had valid baseline and 1 valid post-baseline assessment of an efficacy variable. The last-observation-carried-forward (LOCF) method was used for replacing the missing values of the post-baseline assessments for ITT analysis at wk 8.||mm Hg||Standard Deviation|Mean
781225|NCT00809926|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8|To compare the change from baseline in MSSBP after 8 weeks of treatment with a valsartan and aliskiren treatment regimen (160/150 mg, 320/300 mg) versus a valsartan treatment regimen (160 mg, 320 mg) in patients with Stage 2 Hypertension.|Baseline to Week 8|Intent-to-treat (ITT) population consisted of all randomized patients who received at least 1 dose of study drug and had valid baseline and 1 valid post-baseline assessment of an efficacy variable. The last-observation-carried-forward (LOCF) method was used for replacing the missing values of the post-baseline assessments for ITT analysis at wk 8.||mm Hg||Standard Deviation|Mean
781226|NCT00809965|Secondary|The Percentage of Patients With the Composite of Cardiovascular Death, Myocardial Infarction, Stroke, or Severe Recurrent Ischemia Leading to Hospitalization|The percentage of patients with the first occurrence of the composite endpoint. The statistical analysis was based on the time from randomization to the first occurrence of the event while on treatment.|From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)|The Modified Intent-to-Treat (mITT) population consisted of all randomized patients, regardless of treatment exposure, excluding sites 091001, 091019, and 091026 (excluded due to potential trial misconduct). The mITT population was also subject to censoring of events that occurred on, or after, the global treatment end date.||Percentage of patients|||Number
781227|NCT00809965|Secondary|The Percentage of Patients With the Composite of Cardiovascular Death, Myocardial Infarction, Stroke, or Severe Recurrent Ischemia Requiring Revascularization|The percentage of patients with the first occurrence of the composite endpoint. The statistical analysis was based on the time from randomization to the first occurrence of the event while on treatment.|From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)|The Modified Intent-to-Treat (mITT) population consisted of all randomized patients, regardless of treatment exposure, excluding sites 091001, 091019, and 091026 (excluded due to potential trial misconduct). The mITT population was also subject to censoring of events that occurred on, or after, the global treatment end date.||Percentage of patients|||Number
781228|NCT00809965|Secondary|The Percentage of Patients With the Composite of Cardiovascular Death, Myocardial Infarction, Ischemic Stroke, or TIMI Major Bleeding Event Not Associated With Coronary Artery Bypass Graft Surgery|The percentage of patients with the first occurrence of the composite endpoint. The statistical analysis was based on the time from randomization to the first occurrence of the event while on treatment.|From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)|The Modified Intent-to-Treat (mITT) population consisted of all randomized patients, regardless of treatment exposure, excluding sites 091001, 091019, and 091026 (excluded due to potential trial misconduct). The mITT population was also subject to censoring of events that occurred on, or after, the global treatment end date.||Percentage of patients|||Number
781229|NCT00809965|Secondary|The Percentage of Patients With the Composite of All Cause Death, Myocardial Infarction, or Stroke|The percentage of patients with the first occurrence of the composite endpoint. The statistical analysis was based on the time from randomization to the first occurrence of the event while on treatment.|From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)|The Modified Intent-to-Treat (mITT) population consisted of all randomized patients, regardless of treatment exposure, excluding sites 091001, 091019, and 091026 (excluded due to potential trial misconduct). The mITT population was also subject to censoring of events that occurred on, or after, the global treatment end date.||Percentage of patients|||Number
781230|NCT00809965|Primary|The Percentage of Patients With the Composite Endpoint of Cardiovascular Death, Myocardial Infarction, or Stroke|The percentage of patients with the first occurrence of the composite of death, myocardial infarction, or stroke. The statistical analysis was based on the time from randomization to the first occurrence of the event while on treatment.|From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)|The Modified Intent-to-Treat (mITT) population consisted of all randomized patients, regardless of treatment exposure, excluding sites 091001, 091019, and 091026 (excluded due to potential trial misconduct). The mITT population was also subject to censoring of events that occurred on, or after, the global treatment end date.||Percentage of patients|||Number
781231|NCT00810043|Secondary|Change in Ambulatory Status|Ambulatory status was assessed by subjective patient questionnaire.|Baseline and 48 hrs post-procedure|Modified intention to treat - all randomized patients who received balloon kyphoplasty treatment.||participants|||Number
781232|NCT00810043|Secondary|Change in Back Pain.|Back pain was assessed by a numeric rating scale (Scale 1-10), with higher scores denoting worse pain.|Baseline and 48 hr post-procedure|Modified intention to treat - all randomized patients who received balloon kyphoplasty treatment.||units on a scale||Standard Deviation|Mean
781233|NCT00810043|Secondary|Deformity Correction Assessed by Local Cobb Angle (LCA)|The local Cobb angle (LCA) was defined as the angle formed by lines drawn parallel to the superior endplate of the vertebral body above and the inferior endplate of the vertebral body below. Correction of angular deformity was expressed as a difference of absolute values between pre- and post-operative values. Any positive change indicated an improvement of angular correction and was defined as a change in angulation toward 0 degrees. Any negative change indicated a worsening of angular correction, and is defined as a change away from 0 degrees.|baseline and 48 hr post-procedure|Modified intention to treat - all randomized patients who received balloon kyphoplasty treatment.||degree||Standard Deviation|Mean
781263|NCT00810199|Secondary|Time to Restart of Treatment After Discontinuation/Remission|The time in days from treatment discontinuation or remission to the restart of treatment.|104 Weeks|Participants from the intent-to-treat population, all participants who received study drug, with data available for analysis. Censoring occurred at the last assessment for those completing the study or withdrawing early, if a response had not been observed.||Days||95% Confidence Interval|Median
781234|NCT00810043|Secondary|Deformity Correction Assessed by Vertebral Body Kyphosis Angle (VBA)|The vertebral body kyphosis angle (VBA) was defined as the angle formed by lines drawn parallel to the caudal and cranial fractured vertebral body endplates. Correction of angular deformity was expressed as a difference of absolute values between pre- and post-operative values. Any positive change indicated an improvement of angular correction and was defined as a change in angulation toward 0 degrees. Any negative change indicated a worsening of angular correction, and is defined as a change away from 0 degrees.|Baseline and 48 hr post-procedure|Modified intention to treat - all randomized patients who received balloon kyphoplasty treatment.||degree||Standard Deviation|Mean
781235|NCT00810043|Secondary|Amount of Vertebra Body Height (VBH) Gained by Postural Reduction||baseline and intra-operative|Modified intention to treat - all randomized patients who received balloon kyphoplasty treatment.||mm||Standard Deviation|Mean
781236|NCT00810043|Secondary|Amount of Vertebral Body Height (VBH) Gained From IBTs Alone|Since all patients were treated in the prone position with chest and hip bolsters (this is referred to as postural reduction), vertebral body height (VBH) gained from IBTs alone was reported as the change of vertebral body height measured intra-operatively after postural reduction with bolsters to the 1st round of IBT inflation.|Intra-operative measurement after postural reduction with Bolsters and intra-operative measurement after 1st round of IBT inflation.|Modified intention to treat - all randomized patients who received balloon kyphoplasty treatment.||mm||Standard Deviation|Mean
781237|NCT00810043|Secondary|Index Vertebral Body Height Restored in Millimeters.|Vertebral Body Height (VBH) was measured at anterior, midpoint, and posterior of index vertebral bodies. The data presented is the absolute height restored (AHR) between two time points.|Baseline and 48 hours after procedure|Modified intention to treat - all randomized patients who received balloon kyphoplasty treatment.||mm||Standard Deviation|Median
781238|NCT00810043|Primary|Absolute Vertebral Body Height Restoration as a Percent (Post-procedure Change From Baseline)||Baseline and 48-hr post-procedure|Modified intention to treat - all randomized patients who received balloon kyphoplasty treatment||percent change||Standard Deviation|Mean
781239|NCT00810069|Secondary|Number of Participants With Adverse Events (AEs)|The list of AEs is located in the Reported Adverse Event module.|Baseline through Week 16|Full Analysis Population||participants|||Number
781240|NCT00810069|Secondary|Resource Utilisation - Has the Participant Been Hospitalized Due to Depression in the Last 4 Weeks - Number of Participants With a Yes Response||Week 4, Week 8, Week 12, Week 16|Full Analysis Population||participants|||Number
781241|NCT00810069|Secondary|Resource Utilisation - Number of Visits to Other Specialists Due to Depression in the Last 4 Weeks||Week 4, Week 8, Week 12, Week 16|Full Analysis Population, which included all randomized participants with at least 1 post-randomization assessment available after Week 4. For efficacy analyses, participants were included in the analysis if they had a baseline and a post-baseline (after Week 4) value of the variable in question.||Visits||Standard Deviation|Mean
781242|NCT00810069|Secondary|Resource Utilisation - Number of Visits to Primary Healthcare Provider Due to Depression in the Last 4 Weeks||Week 4, Week 8, Week 12, Week 16|Full Analysis Population, which included all randomized participants with at least 1 post-randomization assessment available after Week 4. For efficacy analyses, participants were included in the analysis if they had a baseline and a post-baseline (after Week 4) value of the variable in question.||Visits||Standard Deviation|Mean
781243|NCT00810069|Secondary|Resource Utilisation - Number of Work Hours Missed Due to Depression in the Last 4 Weeks|Only those participants who missed at least 1 hour of work due to depression were included.|Week 4, Week 8, Week 12, Week 16|Full Analysis Population, which included all randomized participants with at least 1 post-randomization assessment available after Week 4. For efficacy analyses, participants were included in the analysis if they had a baseline and a post-baseline (after Week 4) value of the variable in question.||Hours||Standard Deviation|Mean
781244|NCT00810069|Secondary|Resource Utilisation - Number of Work Hours Missed in the Last 4 Weeks|Only those participants who missed at least 1 hour of work were included.|Week 4, Week 8, Week 12, Week 16|Full Analysis Population, which included all randomized participants with at least 1 post-randomization assessment available after Week 4. For efficacy analyses, participants were included in the analysis if they had a baseline and a post-baseline (after Week 4) value of the variable in question.||Hours||Standard Deviation|Mean
781245|NCT00810069|Secondary|Resource Utilisation - Number of Hours Worked Per Week||Baseline, Week 4, Week 8, Week 12, Week 16|Full Analysis Population, which included all randomized participants with at least 1 post-randomization assessment available after Week 4. For efficacy analyses, participants were included in the analysis if they had a baseline and a post-baseline (after Week 4) value of the variable in question.||Hours||Standard Deviation|Mean
781246|NCT00810069|Primary|Estimated Probability of Not Reaching Confirmed Remission at 12 Weeks Based on the Survival Function for the Time to Confirmed Remission|Survival function is estimating the probability of participants not achieving confirmed remission. Confirmed remission is defined as a Hamilton Depression Rating Scale-17 Items (HAMD-17) Score of ≤ 7 that is maintained for two consecutive visits. The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).|Week 4 through Week 16|Full Analysis Population||estimated probability (percent)||95% Confidence Interval|Mean
781247|NCT00810069|Primary|Time to Confirmed Remission by a Hamilton Depression Rating Scale-17 Items (HAMD-17) Score of ≤ 7 That is Maintained for Two Consecutive Visits|Time to confirmed remission is defined as the time from the day of study randomization (Visit 2) to the date of first observation of confirmed remission defined as a score on the HAMD-17 of ≤ 7 for 2 consecutive visits. The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).|Week 4 through Week 16|Full Analysis Population||weeks||95% Confidence Interval|Median
781248|NCT00810069|Secondary|Sheehan Disability Scale (SDS) Normal Functioning Total Score|The SDS is completed by the participant and is used to assess the effect of the participant's symptoms on their work/social/family life. Total scores range from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life.|Baseline, Week 4, Week 8, Week 12, Week 16|Full Analysis Population||units on a scale||Standard Deviation|Mean
781249|NCT00810069|Secondary|Euro Quality of Life Questionnaire-5 Dimensions (EQ-5D) Scale - United Kingdom (UK) Population Based Index Score|The EQ-5D is a generic, multidimensional, health-related, quality of life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 is generated for each domain. For each participant, the outcome rating on the 5 domains will be mapped to a single index through an algorithm. The index ranges between 0 and 1, with the higher score indicating a better health state perceived by the participant.|Baseline, Week 4, Week 8, Week 12, Week 16|Full Analysis Population||units on a scale||Standard Deviation|Mean
781250|NCT00810069|Secondary|Euro Quality of Life Questionnaire-5 Dimensions (EQ-5D) Scale - Health State Score|The EQ-5D Health State Score is self-rated health on a vertical, visual analogue scale measured in centimeters (cm) and reported as units on a scale. Best imaginable health state = 10 cm and worst imaginable health state = 0 cm.|Baseline, Week 4, Week 8, Week 12, Week 16|Full Analysis Population||units on a scale||Standard Deviation|Mean
781251|NCT00810069|Secondary|Visual Analog Scale (VAS) - Overall Pain Severity|VAS for pain consists of 6 questions that assess overall pain, headache, back pain, shoulder pain, pain interference with daily activities, and pain while awake. Participant rates pain on a 10 centimeter (cm) line between two anchors (0= no pain and 10=very severe pain).|Baseline, Week 4, Week 6, Week 8, Week 10, Week 12, Week 14, Week 16|Full Analysis Population||units on a scale||Standard Deviation|Mean
781252|NCT00810069|Secondary|Clinical Global Impressions of Severity (CGI-S) Scale|Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).|Baseline, Week 4, Week 6, Week 8, Week 10, Week 12, Week 14, Week 16|Full Analysis Population||units on a scale||Standard Deviation|Mean
781253|NCT00810069|Secondary|Time to Confirmed Remission as Defined by a 16-Item Quick Inventory of Depressive Symptomatology Self Report (QIDS16SR) Score of ≤ 5 That is Maintained for Two Consecutive Visits.|Time to confirmed remission is defined as the time from the day of study randomization (Visit 2) to the date of first observation of confirmed remission. A 16-item participant-rated measure of depressive symptomatology. The total score ranges from 0 to 27 with higher scores indicative of greater severity.|Week 4 through Week 16|Full Analysis Population||weeks||95% Confidence Interval|Median
781254|NCT00810069|Secondary|Time to Confirmed Response as Defined by ≥ 50% Reduction From Baseline Reduction in the 16-Item Quick Inventory of Depressive Symptomatology Self Report (QIDS16SR) That is Reported for Two Consecutive Visits|Time to confirmed response is defined as the time from the day of study randomization (Visit 2) to the date of first observation of confirmed response. QIDS16SR is a 16-item participant-rated measure of depressive symptomatology. The total score ranges from 0 to 27 with higher scores indicative of greater severity.|Week 4 through Week 16|Full Analysis Population||weeks||95% Confidence Interval|Median
781255|NCT00810069|Primary|Estimated Probability of Not Reaching Confirmed Response at 12 Weeks Based on the Survival Function for the Time to Confirmed Response|Survival function is estimating the probability of participants not achieving confirmed response after 12 weeks. Confirmed response is defined as >=50% change from baseline reduction in the Hamilton Depression Rating Scale-17 Items (HAMD-17). The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).|Week 4 through Week 16|Full Analysis Population||estimated probability (percent)||95% Confidence Interval|Mean
781256|NCT00810069|Primary|Time to Confirmed Response by ≥ 50% Change From Baseline Reduction in the Hamilton Depression Rating Scale-17 Items (HAMD-17)|Time to confirmed response is defined as the time from the day of study randomization (Visit 2) to the date of first observation of confirmed response defined as ≥ 50% baseline score reduction on the HAMD-17 for 2 consecutive visits. The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale, e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).|Week 4 through Week 16|Full Analysis Set||weeks||95% Confidence Interval|Median
781257|NCT00810082|Primary|Participants With at Least One Fall|Subjects who had at least one fall subsequent to treatment.|3 months|||participants|||Number
781258|NCT00810095|Secondary|Number of Device-related Serious Adverse Events|Evaluation of the safety of using the MindFrame System based on device-related serious adverse event(s). Device-related serious adverse events are defined as vessel perforation, intramural arterial dissection, device-related symptomatic intracranial hemorrhage, and significant embolization in a previously uninvolved arterial territory.|Treatment to 90 days postprocedure|Per protocol analysis of all participants treated with the 1st generation MindFrame System of neurothrombotic stent retrievers.||events|||Number
781259|NCT00810095|Primary|Clinical Success|Clinical Success as determined by achievment of a Modified Rankin Scale score of 0-2 at 90 days postprocedure. The modified Rankin Scale is a measure of a patient's level of functional independence with 0=normal and 6-death. Patients with a score of 0-2 are considered functionally independent.|90 days postprocedure|Percentage of participants achieving a Modified Rankin Scale score of 0-2 at 90 days postprocedure.||percentage of participants|||Number
781260|NCT00810095|Primary|Procedural Success as Determined by the Overal Percentage of Patients Who Achieve TIMI Grade 2/3 Flow, With or Without the Use of Adjuvant Therapy, in All Treatable Vessels as Confirmed by the Final Post Treatment Angiogram.|"TIMI Flow is a scoring system from 0-3 referring to levels of blood flow assessed during percutaneous coronary angioplasty:
TIMI 0 flow (no perfusion) TIMI 1 flow (penetration without perfusion) TIMI 2 flow (partial reperfusion) TIMI 3 flow (complete perfusion) is normal flow"|Immediately postprocedure|Percentage of participants who achieved (TIMI/TICI grade 2/3 flow), with or without the use of adjuvant therapy, in all treatable vessels as confirmed by the final post treatment angiogram.||percentage of participants|||Number
781261|NCT00810095|Primary|Technical Device Success by as Assessed by the Percentage of Participants Which Established at Least TIMI 2 Flow Upon Deployment of the System Across the Occlusion and Within 30 Minutes of Placing the Guide Catheter.|"TIMI Flow is a perfusion scoring system from 0-3 referring to levels of blood flow assessed during reperfusion procedures:
TIMI 0 flow (no perfusion) TIMI 1 flow (penetration without perfusion) TIMI 2 flow (partial reperfusion) TIMI 3 flow (complete perfusion) is normal flow"|Immediately postprocedure|All participants treated with the Test System||percentage of participants|||Number
781265|NCT00810199|Secondary|Time to Drug-Free Remission|The time in days from initial study drug treatment to drug free remission that occurred when the participant was able to discontinue tocilizumab, methotrexate/placebo and open label disease-modifying antirheumatic drugs (DMARDS).|104 Weeks|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for this outcome measure. Participants were censored at the last observed value.||Days||Full Range|Median
781266|NCT00810199|Secondary|Time to Tocilizumab Remission|The time in days from initial study drug treatment to tocilizumab remission that occurred when the patient discontinued treatment with tocilizumab.|104 Weeks|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for this outcome measure. Participants were censored at the last observed value.||Days||Full Range|Median
781267|NCT00810199|Secondary|Area Under the Curve (AUC) From Baseline to Week 52 for ACR Response|ACR response was defined as an improvement (reduction) compared with baseline for both total joint count-68 joints and swollen joint count-66 joints, and for three of five variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) where 0=no pain to 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where: 0=no disease activity to 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].Area under the curve for ACR response to Week 52 averaged over study days. Analysis of covariance model includes treatment group, region and baseline DAS28 (<=5.5 and >5.5) as fixed factors.|Baseline to Week 52|Participants from the intent-to-treat population, all participants who received study drug, with ACR response available for analysis at the time-point. Participants with early withdrawals are not included.||Score on a scale*day||Standard Error|Least Squares Mean
781268|NCT00810199|Secondary|Area Under the Curve (AUC) From Baseline to Week 24 for ACR Response|ACR response was defined as an improvement (reduction) compared with baseline for both total joint count-68 joints and swollen joint count-66 joints, and for three of five variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) where 0=no pain to 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where: 0=no disease activity to 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate]. Area under the curve for ACR response to Week 24 was averaged over study days. Analysis of covariance model includes treatment group, region and baseline DAS28 (≤ 5.5 and > 5.5) as fixed factors.|Baseline to Week 24|Participants from the intent-to-treat population, all participants who received study drug, with ACR response available for analysis at the time-point. Participants with early withdrawals are not included.||Score on a scale*day||Standard Error|Least Squares Mean
781269|NCT00810199|Secondary|Change From Baseline in Academic Medical Center (AMC) Linear Disability Scale (ALDS)|The Academic Medical Center (AMC) Linear Disability Score (ALDS) evaluates the participant’s ability to perform activities of daily life consisting of 77 questions answered yes or no . The question difficulty and the patient’s ability are arranged on a single hierarchical linear scale. ALDS scores range from 10 to 90 with a higher score representing higher functional status. A positive change from Baseline indicated improvement.|Baseline, Weeks 104|Participants from the Intent-to-treat population, all randomized participants who received study drug, with data available for analysis.||Score on a scale||Standard Deviation|Mean
781270|NCT00810199|Secondary|Change From Baseline in Rheumatoid Arthritis Quality of Life Questionnaire (RAQoL)|The RAQoL is a disease specific patient-reported outcome measure that determines the effect rheumatoid arthritis has on a patient’s quality of life consisting of 30 questions that are answered either yes=1 or no=0 for a total possible score ranging from 0 (best) to 30 (worst). A negative change from Baseline indicated improvement.|Baseline, Weeks 24, 52, 104|Participants from the intent-to-treat Population, all participants who received study drug, with data available for analysis at the given time-point. The RAQoL score was administered in a subset of sites for which the questionnaire was available in the local language.||Score on a scale||Standard Deviation|Mean
781271|NCT00810199|Secondary|Percentage of Participants Who Withdrew Due to Safety Reasons|Safety reasons were defined as adverse events, intercurrent illness or death. An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events.|Up to 3 years|Intent-to-treat population included all randomized participants who received study drug.||Percentage of participants|||Number
781272|NCT00810199|Secondary|Percentage of Participants Who Withdrew Due to Lack of Sufficient Therapeutic Response|Lack of Sufficient Therapeutic Response was defined as the patient not responding to the drug as expected.|Up to 3 years|Intent-to-treat population included all randomized participants who received study drug.||Percentage of participants|||Number
781273|NCT00810199|Secondary|Percentage of Participants Discontinuing Tocilizumab Due to Remission|The percentage of participants who stopped treatment with tocilizumab due to remission.|Weeks 52, 104|Participants from the Intent-to-treat population (all randomized participants who received study drug) with non-missing DAS28 assessment.||Percentage of participants|||Number
781274|NCT00810199|Secondary|Change From Baseline in Erosion Score|A total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion. The maximum erosion score in the hands was 98 and in the feet 42 for a total possible score of 0 to 140. A lower number change from Baseline indicated a better score.|Baseline, Weeks 24, 52, 104|Participants from the Intent-to-treat population, all randomized participants who received study drug, with data available for analysis at Baseline and the given time point.||Score on a scale||Standard Error|Least Squares Mean
781309|NCT00810303|Secondary|Cmax of Ezetimibe Glucuronide (Steady-state Pharmacokinetic After Chronic Treatment With 10 mg Ezetimibe and Concomitant Chronic Treatment With 400 mg Efavirenz) on Study Day 30|The maximum concentration (Cmax) were obtained directly from the measured concentration-time curves. The concentration-time curve is the result of time points of blood sampling and its measured concentration of ezetimibe glucuronide in the blood samplings.|study day 30|||ng/ml||Standard Deviation|Mean
781275|NCT00810199|Secondary|Change From Baseline in Joint Space Narrowing Score|A total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint). The maximum scores for joint space narrowing (JSN) in the hands was 104 and in the feet 48 for a total possible score of 0 to 152. A lower change from Baseline indicated a better score. Analysis of covariance model included baseline x-ray and DAS28 as covariates and treatment group and region as fixed effects.|Baseline, Weeks 24, 52, 104|Participants from the Intent-to-treat population, all randomized participants who received study drug, with data available for analysis at Baseline and the given time point.||Score on a scale||Standard Error|Least Squares Mean
781276|NCT00810199|Secondary|Change From Baseline in Total Genant Modified Sharp Scores (GSS)|Radiographs were taken of each hand and foot at Baseline, Weeks 24, 52 and104 and were evaluated using the Genant modified method according to Sharp. Erosion Score: A total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion. Joint Narrowing Score: A total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint). The maximum total erosion score in the hands is 98 and in the feet 42. The maximum scores for joint space narrowing (JSN) in the hands was104 and in the feet 48. The total score was the sum of scores for erosions and JSN. The maximum total modified GSS was 292. A lower number change from Baseline was better. Analysis of covariance model, with Baseline DAS28 as a covariate and treatment and site as fixed factors.|Baseline, Weeks 24, 52, 104|Participants from the Intent-to-treat population, all randomized participants who received study drug, with data available for analysis at Baseline and the given time point.||Score on a scale||Standard Error|Least Squares Mean
781277|NCT00810199|Secondary|Change From Baseline in the Health Assessment Questionnaire Disability Index|The Stanford Health Assessment Questionnaire Disability Index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis, consisting of 20 questions in 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. There are 4 possible responses for each question: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty and 3=unable to do. The score for each of the domains is the highest (worst) score in each domain. A patient must have a domain score for at least 6 of 8 domains to calculate a valid HAQ-DI score which is the sum of domain scores, divided by the number of domains that have a score for a total possible score minimum/maximum 0 (best) to 3 (worst). A negative change from Baseline indicated improvement.|Baseline, Weeks 24, 52|Participants from the Intent-to-treat population, all randomized participants who received study drug, with data available for analysis at the given time-point.||Score on a scale||Standard Deviation|Mean
781278|NCT00810199|Secondary|Change From Baseline in C-Reactive Protein (CRP)|Blood was collected for C-Reactive Protein (CRP) (a test for analysis of inflammatory and infectious disorders) and was analyzed at a central laboratory. The serum concentration of CRP was measured in milligrams/deciliter (mg/dL). A reduction in the level is considered an improvement.|Baseline, Weeks 24, 52|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with data available for analysis at the given time-point.||mg/dL||Standard Deviation|Mean
781279|NCT00810199|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR)|Blood was collected for Erythrocyte Sedimentation Rate (ESR) (a test that assesses tissue inflammation) and was analyzed at a local laboratory. ESR was measured in millimeters/hour (mm/hr). A reduction in the level is considered an improvement.|Baseline, Weeks 24, 52|Intent-to-treat population included all randomized participants who received study drug.||mm/hr||Standard Deviation|Mean
781280|NCT00810199|Secondary|Change From Baseline in Patient Global Assessment of Pain (VAS)|"The patient assessed their pain using a 0 to 100 millimeter (mm) horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 mm, and is described as no pain and the right-hand extreme equals 100 mm as unbearable pain. A negative change from Baseline indicated improvement."|Baseline, Weeks 24, 52|Intent-to-treat population included all randomized participants who received study drug.||mm||Standard Deviation|Mean
781281|NCT00810199|Secondary|Change From Baseline in Physician Global Assessment of Disease Activity Visual Analog Scale (VAS)|"The physician global assessment of disease activity was assessed using a 0 to 100 mm horizontal visual analogue scale (VAS) by the physician. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). A negative change from Baseline indicated improvement."|Baseline, Weeks 24, 52|Intent-to-treat population included all randomized participants who received study drug.||mm||Standard Deviation|Mean
781282|NCT00810199|Secondary|Change From Baseline in Patient Global Assessment of Disease Activity Visual Analog Scale (VAS)|"The patients global assessment of disease activity was assessed on a 0 to 100 millimeter (mm) horizontal visual analogue scale (VAS) by the patient. The left-hand extreme of the line equals 0 mm, and was described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). A negative change from Baseline indicated improvement."|Baseline, Weeks 24, 52|Intent-to-treat population included all randomized participants who received study drug.||mm||Standard Deviation|Mean
781283|NCT00810199|Secondary|Change From Baseline in Tender Joint Count|68 joints are assessed for tenderness and joints are classified as tender/not tender giving a total possible tender joint count score of 0 to 68. A negative change from Baseline indicated improvement.|Baseline, Weeks 24, 52|Intent-to-treat population included all randomized participants who received study drug.||Joint count||Standard Deviation|Mean
781284|NCT00810199|Secondary|Change From Baseline in Swollen Joint Count|66 joints were assessed for swelling and joints are classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66. A negative change from Baseline indicated improvement.|Baseline, Weeks 24, 52|Intent-to-treat population included all randomized participants who received study drug.||Joint count||Standard Deviation|Mean
781310|NCT00810303|Secondary|Cmax of Ezetimibe Glucuronide (Steady-state Pharmacokinetic After Chronic Treatment With 10 mg Ezetimibe and Concomitant Single Dose Administration of 400 mg Efavirenz) on Study Day 16|The maximum concentration (Cmax) were obtained directly from the measured concentration-time curves. The concentration-time curve is the result of time points of blood sampling and its measured concentration of ezetimibe glucuronide in the blood samplings.|study day 16|||ng/ml||Standard Deviation|Mean
781285|NCT00810199|Secondary|Percentage of Participants With Good or Moderate European League (EULAR) DAS28 Responses|"The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement.
European League Against Rheumatism (EULAR) Good response: DAS28 ≤ 3.2 or a change from Baseline < -1.2.
EULAR Moderate response: DAS28 > 3.2 to ≤ 5.1 or a change from Baseline < -0.6 to ≥ -1.2."|Baseline, 24, 52|Intent-to-treat population included all randomized participants who received study drug.||Percentage of participants|||Number
781286|NCT00810199|Secondary|Change From Baseline in DAS28 Score|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A higher value indicated higher disease activity. A negative change from Baseline indicated improvement.|Baseline, Weeks 24, 52|Intent-to-treat population included all randomized participants who received study drug.||Score on a scale||Standard Deviation|Mean
781287|NCT00810199|Secondary|Percentage of Participants With DAS28 Low Disease Activity (LDAS)|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. LDAS is defined as DAS28 ≤ 3.2.|Weeks 24, 52|Intent-to-treat population included all randomized participants who received study drug.||Percentage of participants|||Number
781288|NCT00810199|Secondary|Percentage of Participants With Disease Activity Score 28 (DAS28) Remission|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score < 2.6.|Week 52|Intent-to-treat population included all randomized participants who received study drug.||Percentage of participants|||Number
781289|NCT00810199|Secondary|Area Under Curve (AUC) DAS28|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. AUC DAS28 was averaged over study days. Analysis of Covariance was adjusted for Baseline DAS28 as a covariate and treatment group and region as fixed factors. Higher calculated AUC values are worse (indicate higher disease activity).|Baseline to Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug, with data available at Baseline and Week 24.||Score on a scale*week||Standard Error|Least Squares Mean
781290|NCT00810199|Secondary|Time to First ACR90 Response|Time in days from first administration of study drug until ACR90 response. ACR90 response is defined as a ≥ 90% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].|104 Weeks|Intent-to treat population included all randomized participants who received study drug. Censoring occurred at the last assessment for those completing the study or withdrawing early, if a response was not observed. In calculating ACR response, a last observation carried forward approach is used for missing joint count data.||Days||95% Confidence Interval|Median
781291|NCT00810199|Secondary|Time to First ACR70 Response|Time in days from first administration of study drug until ACR70 response. ACR70 response is defined as a ≥ 70% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].|104 Weeks|Intent-to treat population included all randomized participants who received study drug. Censoring occurred at the last assessment for those completing the study or withdrawing early, if a response was not observed. In calculating ACR response, a last observation carried forward approach is used for missing joint count data.||Days||95% Confidence Interval|Median
781311|NCT00810303|Secondary|Cmax of Ezetimibe Glucuronide (Steady-state Pharmacokinetic After Chronic Treatment With 10 mg Ezetimibe) on Study Day 15|The maximum concentration (Cmax) were obtained directly from the measured concentration-time curves. The concentration-time curve is the result of time points of blood sampling and its measured concentration of ezetimibe glucuronide in the blood samplings.|study day 15|||ng/ml||Standard Deviation|Mean
781292|NCT00810199|Secondary|Time to First ACR50 Response|Time in days from first administration of study drug until ACR50 response. ACR50 response is defined as a ≥ 50% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate).|104 Weeks|Intent-to treat population included all randomized participants who received study drug. Censoring occurred at the last assessment for those completing the study or withdrawing early, if a response was not observed. In calculating ACR response, a last observation carried forward approach is used for missing joint count data.||Days||95% Confidence Interval|Median
781293|NCT00810199|Secondary|Time to First ACR20 Response|Time in days from first administration of study drug until ACR20 response. ACR20 response is defined as a ≥ 20% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].|104 Weeks|Intent-to treat population included all randomized participants who received study drug. Censoring occurred at the last assessment for those completing the study or withdrawing early, if a response was not observed. In calculating ACR response, a last observation carried forward approach is used for missing joint count data.||Days||95% Confidence Interval|Median
781294|NCT00810199|Secondary|Percentage of Participants With ACR90 Response|ACR90 response is defined as a ≥ 90% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].|Baseline, Weeks 24, 52, 104|Intent-to-treat population included all randomized participants who received study drug.||Percentage of participants|||Number
781295|NCT00810199|Secondary|Percentage of Participants With ACR70 Response|ACR70 response is defined as a ≥ 70% improvement (reduction) compared with Baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].|Baseline, Weeks 24, 52, 104|Intent-to-treat population included all randomized participants who received study drug.||Percentage of participants|||Number
781296|NCT00810199|Secondary|Percentage of Participants With ACR50 Response|ACR50 response is defined as a ≥ 50% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].|Baseline, Weeks 24, 52, 104|Intent-to-treat population included all randomized participants who received study drug.||Percentage of participants|||Number
781297|NCT00810199|Secondary|Percentage of Participants With American College of Rheumatology (ACR20) Response|ACR20 response is defined as a ≥ 20% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].|Baseline, Weeks 24, 52, 104|Intent-to-treat population included all randomized participants who received study drug.||Percentage of participants|||Number
781521|NCT00795600|Secondary|Absolute Change in Free Fatty Acids||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the free fatty acids at week 26.||mg/dL||Standard Deviation|Mean
781298|NCT00810199|Primary|Percentage of Participants With Disease Activity Score 28 Joints (DAS28) Remission at Week 24|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score < 2.6.|Week 24|Intent-to-treat population included all randomized participants who received study drug.||Percentage of participants|||Number
781299|NCT00810277|Secondary|Neutrophil Count||Baseline, Weeks 4, 8, and 12|Analysis population included all participants who entered the study. 'n'=number of participants evaluable for specified category.||E^9 per liter||Standard Deviation|Mean
781300|NCT00810277|Secondary|Percentage of Participants With Lipid Level Elevations|Low density lipoprotein (LDL) level was categorized as 'Optimal (less than [<] 100 milligram per deciliter [mg/dL])', 'Near Optimal/Above Optimal (100-129 mg/dL)', 'Borderline High (130-159 mg/dL)', 'High (160-189 mg/dL)', and 'Very high (190 mg/dL)'. High density lipoprotein (HDL) level was categorized as ‘Acceptable (40-59 mg/dL)’, ‘High (>=60 mg/dL)’. Total cholesterol (TC) level was categorized as ‘Desirable (<200 mg/dL)’, ‘Borderline High (200-239 mg/dL)’, ‘High (>=240 mg/dL)’.|Week 24|Analysis population included all participants who entered the study.||percentage of participants|||Number
781301|NCT00810277|Secondary|Percentage of Participants With Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) Level Elevation More Than 1.5 Times Upper Limit of Normal|Normal range of ALT is 7 to 56 units per liter (U/L) of serum. Normal range of AST is 5 to 40 units per liter (U/L) of serum.|Up to Week 24|Analysis population included all participants who entered the study.||percentage of participants|||Number
781302|NCT00810277|Secondary|Percentage of Participants Who Discontinued the Study||Up to Week 24|Analysis population included all participants who entered the study.||percentage of participants|||Number
781303|NCT00810277|Secondary|Erythrocyte Sedimentation Rate (ESR)|The erythrocyte sedimentation rate (ESR) is the rate at which red blood cells sediment in a period of one hour.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|Analysis population included all participants who entered the study. 'n'=number of participants evaluable for specified category.||millimeter per hour (mm/h)||Standard Deviation|Mean
781304|NCT00810277|Secondary|C-Reactive Protein (CRP) Level||Baseline, Weeks 4, 8, 12, 16, 20, and 24|Analysis population included all participants who entered the study. 'n'=number of participants evaluable for specified category.||milligram per liter (mg/L)||Standard Deviation|Mean
781305|NCT00810277|Secondary|Percentage of Participants Achieving American College of Rheumatology (ACR) 20% (ACR20), ACR50 and ACR70 Response|ACR20, ACR50, and ACR70 response: greater than or equal to (>=) 20 percent (%), 50%, and 70% improvement respectively, in tender or swollen joint counts and in 3 of the following criteria: (1) Participant's assessment of pain (measured on a 0 to 100 mm VAS where 0=no pain and 100=unbearable pain); (2) Participant's assessment of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity); (3) Investigator's global assessment of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity); (4) Participant's assessment of functional disability via health assessment questionnaire (HAQ) (measured using 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do).|Weeks 4, 8, 12, 16, 20, and 24|Analysis population included all participants who entered the study. 'n'=number of participants evaluable for specified category.||percentage of participants|||Number
781306|NCT00810277|Secondary|Percentage of Participants Achieving DAS28 Remission (DAS28 <2.6)|DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) or CRP (mg/dL), and general health (GH) status (measured on a 0 to 100 mm Visual Analogue Scale [VAS] where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using following formulas: DAS28-ESR = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*GH of disease activity; DAS28-CRP = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(10*CRP+1) + 0.014*GH of disease activity. DAS28-ESR was adopted to calculate DAS28 if effective ESR data was available; otherwise DAS28-CRP was adopted to calculate DAS28. Total score range: 0-10, higher score=more disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission.|Weeks 4, 8, 12, 16, 20, and 24|Analysis population included all participants who entered the study. 'n'=number of participants evaluable for specified category.||percentage of participants|||Number
781307|NCT00810277|Secondary|Disease Activity Score (DAS28)|DAS28 was calculated from swollen joint count (SJC) and tender joint count (TJC) using 28 joints count, erythrocyte sedimentation rate (ESR) (mm/hour) or C-reactive protein (CRP) (mg/dL), and general health (GH) status (measured on a 0 to 100 mm Visual Analogue Scale [VAS] where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using following formulas: DAS28-ESR = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*GH of disease activity; DAS28-CRP = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(10*CRP+1) + 0.014*GH of disease activity. DAS28-ESR was adopted to calculate DAS28 if effective ESR data was available; otherwise DAS28-CRP was adopted to calculate DAS28. Total score range: 0-10, higher score=more disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|Analysis population included all participants who entered the study. 'n'=number of participants evaluable for specified category.||units on a scale||Standard Deviation|Mean
781308|NCT00810277|Primary|Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both serious as well as non-serious AEs.|Baseline up to Week 24|Analysis population included all participants who entered the study.||percentage of participants|||Number
781312|NCT00810303|Secondary|AUC0-24h of Ezetimibe Glucuronide (Steady-state Pharmacokinetic After Chronic Treatment With 10 mg Ezetimibe and Concomitant Chronic Treatment With 400 mg Efavirenz) on Study Day 30|The area under the concentrations-time curve (AUC0-24) was calculated with the measured data points from the time of administration up to 24 h after administration by the trapezoidal formula. The concentration-time curve is the result of time points of blood sampling and its measured concentration of ezetimibe glucuronide in the blood samplings.|study day 30|||ng*h/ml||Standard Deviation|Mean
781313|NCT00810303|Secondary|AUC0-24h of Ezetimibe Glucuronide (Steady-state Pharmacokinetic After Chronic Treatment With 10 mg Ezetimibe and Concomitant Single Dose Administration of 400 mg Efavirenz) on Study Day 16|The area under the concentrations-time curve (AUC0-24) was calculated with the measured data points from the time of administration up to 24 h after administration by the trapezoidal formula. The concentration-time curve is the result of time points of blood sampling and its measured concentration of ezetimibe glucuronide in the blood samplings.|study day 16|||ng*h/ml||Standard Deviation|Mean
781314|NCT00810303|Secondary|AUC0-24h of Ezetimibe Glucuronide (Steady-state Pharmacokinetic After Chronic Treatment With 10 mg Ezetimibe) on Study Day 15|The area under the concentrations-time curve (AUC0-24) was calculated with the measured data points from the time of administration up to 24 h after administration by the trapezoidal formula. The concentration-time curve is the result of time points of blood sampling and its measured concentration of ezetimibe glucuronide in the blood samplings.|study day 15|||ng*h/ml||Standard Deviation|Mean
781315|NCT00810303|Primary|Cmax of Efavirenz (Steady State Pharmacokinetic After Chronic Treatment With 400 mg Efavirenz and Concomitant Chronic Treatment of 10 mg Ezetimibe) on Study Day 30|The maximum concentration (Cmax) were obtained directly from the measured concentration-time curves. The concentration-time curve is the result of time points of blood sampling and its measured concentration of efavirenz in the blood samplings.|study day 30|||ng/ml||Standard Deviation|Mean
781316|NCT00810303|Primary|Cmax of Efavirenz (Single Dose Pharmacokinetic After Treatment With 400 mg Efavirenz and Concomitant Chronic Treatment of 10 mg Ezetimibe) on Study Days 16-20|The maximum concentration (Cmax) were obtained directly from the measured concentration-time curves. The concentration-time curve is the result of time points of blood sampling and its measured concentration of efavirenz in the blood samplings.|study days 16-20|||ng/ml||Standard Deviation|Mean
781317|NCT00810303|Primary|Cmax of Efavirenz (Single Dose Pharmacokinetic After Treatment With 400 mg Efavirenz) on Study Days 1-5|The maximum concentration (Cmax) were obtained directly from the measured concentration-time curves. The concentration-time curve is the result of time points of blood sampling and its measured concentration of efavirenz in the blood samplings.|study days 1-5|||ng/ml||Standard Deviation|Mean
781318|NCT00810303|Primary|AUC0-24h of Efavirenz (Steady State Pharmacokinetic After Chronic Treatment With 400 mg Efavirenz and Concomitant Chronic Treatment of 10 mg Ezetimibe) on Study Day 30|The area under the concentrations-time curve (AUC0-24) was calculated with the measured data points from the time of administration up to 24 h after administration by the trapezoidal formula. The concentration-time curve is the result of time points of blood sampling and its measured concentration of efavirenz in the blood samplings.|study day 30|||ng*h/ml||Standard Deviation|Mean
781319|NCT00810303|Primary|AUC of Efavirenz (Single Dose Pharmacokinetic After Treatment With 400 mg Efavirenz and Concomitant Chronic Treatment of 10 mg Ezetimibe) on Study Days 16-20|The area under the concentrations-time curve (AUC) was calculated with the measured data points from the time of administration until the last quantificable concentration by the trapezoidal formula and the extrapolation to infinity. The concentration-time curve is the result of time points of blood sampling and its measured concentration of efavirenz in the blood samplings.|study days 16-20|||ng*h/ml||Standard Deviation|Mean
781320|NCT00810303|Primary|AUC of Efavirenz (Single Dose Pharmacokinetic After Treatment With 400 mg Efavirenz) on Study Days 1-5|The area under the concentrations-time curve (AUC) was calculated with the measured data points from the time of administration until the last quantificable concentration by the trapezoidal formula and the extrapolation to infinity. The concentration-time curve is the result of time points of blood sampling and its measured concentration of efavirenz in the blood samplings.|study days 1-5|||ng*h/ml||Standard Deviation|Mean
781321|NCT00810303|Primary|Cmax of Free Ezetimibe (Steady-state Pharmacokinetic After Chronic Treatment With 10 mg Ezetimibe and Concomitant Chronic Treatment With 400 mg Efavirenz) on Study Day 30|The maximum concentration (Cmax) were obtained directly from the measured concentration-time curves. The concentration-time curve is the result of time points of blood sampling and its measured concentration of free ezetimibe in the blood samplings.|study day 30|||ng/ml||Standard Deviation|Mean
781322|NCT00810303|Primary|Cmax of Free Ezetimibe (Steady-state Pharmacokinetic After Chronic Treatment With 10 mg Ezetimibe and Concomitant Single Dose Administration of 400 mg Efavirenz) on Study Day 16|The maximum concentration (Cmax) were obtained directly from the measured concentration-time curves. The concentration-time curve is the result of time points of blood sampling and its measured concentration of free ezetimibe in the blood samplings.|study day 16|||ng/ml||Standard Deviation|Mean
781323|NCT00810303|Primary|Cmax of Free Ezetimibe (Steady-state Pharmacokinetic After Chronic Treatment With 10 mg Ezetimibe) on Study Day 15|The maximum concentration (Cmax) were obtained directly from the measured concentration-time curves. The concentration-time curve is the result of time points of blood sampling and its measured concentration of free ezetimibe in the blood samplings.|study day 15|||ng/ml||Standard Deviation|Mean
781324|NCT00810303|Primary|AUC0-24h of Free Ezetimibe (Steady-state Pharmacokinetic After Chronic Treatment With 10 mg Ezetimibe and Concomitant Chronic Treatment With 400 mg Efavirenz) on Study Day 30|The area under the concentrations-time curve (AUC0-24) was calculated with the measured data points from the time of administration up to 24 h after administration by the trapezoidal formula. The concentration-time curve is the result of time points of blood sampling and its measured concentration of free ezetimibe in the blood samplings.|study day 30|||ng*h/ml||Standard Deviation|Mean
781325|NCT00810303|Primary|AUC0-24h of Free Ezetimibe (Steady-state Pharmacokinetic After Chronic Treatment With 10 mg Ezetimibe and Concomitant Single Dose Administration of 400 mg Efavirenz) on Study Day 16|The area under the concentrations-time curve (AUC0-24) was calculated with the measured data points from the time of administration up to 24 h after administration by the trapezoidal formula. The concentration-time curve is the result of time points of blood sampling and its measured concentration of free ezetimibe in the blood samplings.|study day 16|||ng*h/ml||Standard Deviation|Mean
781326|NCT00810303|Primary|AUC0-24h of Free Ezetimibe (Steady-state Pharmacokinetic After Chronic Treatment With 10 mg Ezetimibe) on Study Day 15|The area under the concentrations-time curve (AUC0-24) was calculated with the measured data points from the time of administration up to 24 h after administration by the trapezoidal formula. The concentration-time curve is the result of time points of blood sampling and its measured concentration of free ezetimibe in the blood samplings.|study day 15|||ng*h/ml||Standard Deviation|Mean
781327|NCT00810342|Secondary|Accelerometer Collected Moderate to Vigorous Physical Activity|Participant's physical activity (overall moderate-to-vigorous physical activity above 2.9 metabolic equivalents (METs) collected via an accelerometer over 12 months|12-Months|Treatment effect was assessed by a mixed growth model and the F test of the fixed 2-way interaction parameter for time and study condition for overall and of the 3-way interaction parameter for characteristic level, time, and study condition. Adjusted for age, race, BMI, education, #children, employment, depression, baby's age, years in Hawaii||minutes per week moderate-to-vigorous PA||95% Confidence Interval|Mean
781328|NCT00810342|Primary|Minutes of Moderate or Vigorous Physical Activity Per Week After 12-months|Self reported minutes of moderate or vigorous physical activity per week after 12-months|12 months|Treatment effect was assessed by a mixed growth model and the F test of the fixed 2-way interaction parameter for time and study condition for overall and of the 3-way interaction parameter for characteristic level, time, and study condition. Adjusted for age, race, BMI, education, #children, employment, depression, baby's age, years in Hawaii||minutes per week moderate-to-vigorous PA||Inter-Quartile Range|Mean
781329|NCT00810355|Primary|Symptoms|Symptoms (positive, negative, cognitive, hostility, and depression subscales) are rated on Positive and Negative Syndrome Scale (PANSS). These are averages of each subscale: positive (range 6-42), negative (range 8-56), cognitive (range 7-49), hostility (range 4-28), depression (range 4-28). Higher scores indicate more extreme /worse symptoms.|6 months|||scores on a scale||Standard Deviation|Mean
781330|NCT00810355|Primary|Work Quantity|Average number of hours worked per week. Higher numbers represent more hours worked, ranging from 0-40.|6 months|||hours worked per week||Standard Deviation|Mean
781331|NCT00810355|Primary|Work Quality|Average work performance scored on the Work Behavior Inventory (WBI) by total average of the 5 subscales. Scores range from 1-5. Higher scores represent better work performance.|6 months|||scores on a scale||Standard Deviation|Mean
781332|NCT00810368|Primary|Incremental Change in SF36 General Health Between Baseline and Week 12|Incremental change in SF36 General Health score from baseline to week 12. The SF36 General Health score ranges from 0 (very bad General Health) to 100 (very good General Health). The incremental change was the SF36 General Health score at week 12 minus the SF36 General Health score at baseline. The range of scores for incremental change was from -100 to +100. Scores of 0 for SF36 General Health score at baseline and +100 at week 12 indicate an incremental change of 100 - 0 = +100. A score of 100 at baseline for the SF36 General Health score at baseline of +100 at week 12 gives an incremental change of 0 - 100 = -100.|Week 0 and Week 12|Number of participants with evaluable data who completed the study||units on a scale||95% Confidence Interval|Mean
781333|NCT00810368|Primary|Incremental Change in Generalized Anxiety Scale (GAD) Scores From Baseline to Week 12|Each item on the Generalized Anxiety Scale (GAD) scores was scored as none (0), trivial (1), mild (2), moderate (3), or severe (4) and the sum of the 7 items calculated (range 0 to 28). The incremental change between Week 0 and Week 12 was determined for each treatment.|Week 0 and Week 12|Number of participants with evaluable data who completed the study||units on a scale||95% Confidence Interval|Mean
781334|NCT00810368|Primary|SF36 Bodily Pain|Incremental change in Medical Outcome Survey Short Form 36 questionnaire (SF36) Bodily Pain score from baseline to week 12. The Medical Outcome Survey Short Form 36 questionnaire (SF36) Bodily Pain score ranges from 0 (very bad bodily pain) to 100 (no bodily pain). The incremental change was the Medical Outcome Survey Short Form 36 questionnaire (SF36) Bodily Pain score at week 12 minus the Medical Outcome Survey Short Form 36 questionnaire (SF36) Bodily Pain score at baseline. The range of scores for incremental change was from -100 to +100. Scores of 0 for Medical Outcome Survey Short Form 36 questionnaire (SF36) Bodily Pain score at baseline and +100 at week 12 indicate an incremental change of 100 - 0 = +100. A score of 100 at baseline for the Medical Outcome Survey Short Form 36 questionnaire (SF36) Bodily Pain score at baseline of +100 at week 12 gives an incremental change of 0 - 100 = -100.|Week 0 and Week 12|Number of participants with evaluable data who completed the study||units on a scale||95% Confidence Interval|Mean
781335|NCT00810368|Primary|Incremental Change in Fatigue Score From Baseline to Week 12|Instantaneous Fatigue was scored as none (0) to severe (10) at week 0 and week 12. The difference between the Week 12 minus the Week 0 values was the incremental change. If the incremental change was greater than 0, then the Instantaneous Fatigue was worse at week 12 than week 0. If the incremental change was less than 0, then the Instantaneous Fatigue was improved at week 12 compared to week 0. The total potential range for incremental change was from -10 to +10.|Week 0 and Week 12|Number of participants with evaluable data who completed the study||units on a scale||95% Confidence Interval|Mean
781336|NCT00810368|Secondary|Digit Symbol Substitution (WAIS)|Digit Symbol Substitution (WAIS) test (Joy et al., 2000): Subjects were given a table of numerals with matching symbols, and a form with random numerals with open spaces. The objective was to write in as many symbols that corresponded to the random numerals within a 90 second period. Each subject was their own control. The outcome measure was the incremental change in this score between Week 0 and Week 12 (units on a scale). Higher scores indicate better performance.|Difference between Week 0 and Week 12 (end of study)|2 carnosine subjects had incomplete data.||units on a scale||95% Confidence Interval|Mean
781337|NCT00810368|Primary|Subjects With Improved Diarrhea Symptoms|Patients were given questionnaires assessing common symptom complaints of diarrhea.|Weeks 0 and 12|Participants with evaluable data at the end of the study.||participants|||Number
781357|NCT00788372|Primary|Physician’s Global Assessment Scale|The treating physician assessed the therapeutic efficacy of the treatment by 2 grades: effective and ineffective. Numbers of participants with effective and ineffective therapeutic efficacy with the treatment were reported.|Week 52 or final evaluation (early discontinuation)|The FAS population included all the participants with the exception of participants with violation of eligibility criteria, participants with no treatment with the patch of fentanyl and participants without efficacy data after initiation of patch application.||participants|||Number
781338|NCT00810368|Primary|Effect of Carnosine Supplementation on Chronic Fatigue Syndrome Severity Scores|"CFS Severity Score (Δ ≥ 5 / 36) (Baraniuk et al., 1998; Baraniuk et al., 2000a; Baraniuk, Naranch, Maibach, & Clauw, 2000b). Subjects scored the severity of the 9 CFS criteria (Fatigue, memory/concentration, sore throat, sore lymph nodes, sore muscles, sore joints, headache, sleep disturbances, exertional exhaustion from Fukuda et al. 1994) on a scale of none (score=0), trivial (1), mild (2), moderate (3) and severe (4). The sum was 36.
Individuals taking carnosine were predicted to show a decrease of ≥ 5 at week 12 compared to week 0, compared to no change for placebo subjects. 2-tailed paired t-tests were used to determine significant incremental changes for individuals in the carnosine group compared to the placebo group."|Weeks 0 and 12|Significant numbers of subjects dropped out of both arms of the study. The primary reason given was perceived lack of efficacy.||units on a scale||95% Confidence Interval|Mean
781339|NCT00810394|Secondary|Time to Disease Progression|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Up to 2 years|||months||95% Confidence Interval|Median
781340|NCT00810394|Secondary|Overall Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR).|At least 3 months|Of the 34 patients who were evaluable for treatment response by RECIST, no responses were observed.||Participants|||Count of Participants
781341|NCT00810394|Primary|Percentage of Patients Tolerating Re-escalated Dose of Sorafenib for 28 Days Without Dose Interruption or De-escalation for Toxicity|Overall percentage of patients tolerating a dose escalation to 600 mg twice daily for 28 days plus the percentage tolerating a re-escalation to 400 mg twice daily in Cycle 3.|At least 3 months|||Participants|||Count of Participants
781342|NCT00810511|Primary|Comfort at End of Day|Evaluated by the subject as a single, retrospective evaluation of 4-week wear time. Measured on a 10-point scale, with 1 being poor and 10 being excellent.|After 4 weeks of wear|One subject in the Lotrafilcon A arm was excluded from efficacy analysis due to a protocol deviation.||Scale of 1-10||Standard Deviation|Mean
781343|NCT00810576|Primary|Number of Patients With Response|Computed tomography scans and/or Positron emission tomography (PET) scans obtained every two cycles to evaluate response using International Workshop Criteria of Complete Response, Partial Response, Progressive Disease, or Stable Disease.|Every two 21-day cycles|No analysis done due to early termination resulting from low accrual.||participants|||Number
781344|NCT00810602|Secondary|Percent Survival at 2-years|To determine 2-year overall survival rate|two years|evaluable subjects||percentage of subjects|||Number
781345|NCT00810602|Secondary|Percent Cumulative Incidence of Relapse at 2 Years.|Determine the cumulative incidence of relapse at 2 years.|two years|evaluable subjects||percentage of participants|||Number
781346|NCT00810602|Secondary|Number of Serious Adverse Events|The safety and feasibility will be partially measured by the number of serious adverse events (SAE) recorded by participants receiving at least one dose of Vorinostat.|100 days|The number of patients who received at least one dose of vorinostat.||Number of Serious Adverse Events|||Number
781347|NCT00810602|Primary|100-day Cumulative Incidence of Grade 2-4 Acute Graft Versus Host Disease (GVHD)|Assess if the addition of Vorinostat to standard GVHD prophylaxis regimen can reduce the rate of grades 2-4 acute GVHD when compared to 48% in a cohort of identically treated RIC HSCT patients without vorinostat. A reduction of incidence to less than 25% will be considered successful.|100 days|evaluable||percentage of participants|||Number
781348|NCT00788255|Primary|TTG|thromboelastographic indices - total thrombus generation (normal range, 584-796 mm)|6 months|||mm||Standard Deviation|Mean
781349|NCT00788255|Primary|Tmax|thromboelastographic indices - time to initiation of clot formation plus time to achieve maximum rate of clot strength development (normal range, 6-12 min)|6 months|||minutes||Standard Deviation|Mean
781350|NCT00788255|Primary|MRTG|thromboelastographic indices - maximum rate of thrombus generation (normal range, 5-17 mm/min)|6 months|||mm/min||Standard Deviation|Mean
781351|NCT00788255|Primary|MA|thromboelastographic indices - maximum amplitude (normal range, 50-70 mm)|6 months|||mm||Standard Deviation|Mean
781352|NCT00788255|Primary|Alpha Angle|thromboelastographic - alpha angle = clot formation rate (normal range, 53 degress to 72 degrees)|6 months|||degrees||Standard Deviation|Mean
781353|NCT00788255|Primary|k Time|thromboelastographic indices - clot formation time (normal range, 1-3 min)|6 months|||minutes||Standard Deviation|Mean
781354|NCT00788255|Primary|r Time|thromboelastographic indices - reaction time (normal range, 5-10 min)|6 months|||minutes||Standard Deviation|Mean
781355|NCT00788372|Primary|Brief Pain Inventory-Short Form (BPI-SF) Total Score|The BPI-SF is a self-report questionnaire designed to assess the severity and impact of pain on daily functions. It includes pain interference score which is mean value for scores for 9 BPI-SF questions ranging between 0 (does not interfere) to 10 (completely interferes) and pain subscale score which is mean value for scores for BPI-SF questions 3 to 6 ranging between 0 (no pain) to 10 (pain as bad as can imagine). Total BPI-SF score is an average of pain interference score and pain subscale score and ranges from 0 to 10; higher score indicates more pain or pain interference.|Week 52 or final evaluation (early discontinuation)|The FAS population included all participants with the exception of participants with violation of eligibility criteria, participants with no treatment with the patch of fentanyl and participants without efficacy data after initiation of patch application. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.||units on a scale||Standard Deviation|Mean
781356|NCT00788372|Primary|Participants Overall Assessment|The participants assessed their satisfaction with therapeutic efficacy by 5 grades: satisfied very much, satisfied, equivocal, dissatisfied and dissatisfied very much. Percentage of participants who were at least satisfied (satisfied, satisfied very much) or at least neither satisfied nor dissatisfied (dissatisfied, dissatisfied very much) were reported.|Week 52 or final evaluation (early discontinuation)|The FAS population included all participants with the exception of participants with violation of eligibility criteria, participants with no treatment with the patch of fentanyl and participants without efficacy data after initiation of patch application. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.||percentage of participants||95% Confidence Interval|Number
781358|NCT00788372|Primary|Short-Form 36-Item Health Survey (SF-36) Scores|The SF-36 is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; role emotional, social functioning and mental health contribute to mental component; and social functioning, vitality, and general health contribute to both. All scores are based on a scale from 0 to 100, with higher scores defining more favorable health state.|Week 52 or final evaluation (early discontinuation)|The FAS population included all participants with the exception of participants with violation of eligibility criteria, participants with no treatment with the patch of fentanyl and participants without efficacy data after initiation of patch application. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.||units on a scale||Standard Deviation|Mean
781359|NCT00788372|Primary|Number of Rescue Treatments|Rescue treatment was used for participants with lack of analgesic efficacy, to have relief from breakthrough pain and in cases where withdrawal symptoms occur. The reference one-time rescue dose used was oral morphine 5 milligram (mg) for the investigational product fentanyl one-day transdermal patch 12.5 mcg per hr. The number of rescue treatments per day were reported.|Week 52 or final evaluation (early discontinuation)|The FAS population included all the participants with the exception of participants with violation of eligibility criteria, participants with no treatment with the patch of fentanyl and participants without efficacy data after initiation of patch application.||treatments per day||Standard Deviation|Mean
781360|NCT00788372|Primary|Number of Participants With Quality of Sleep|The quality of sleep was assessed by participants that how well they have slept from the previous assessment to current assessment time by the following 4 grades: can sleep well, can sleep moderately well, cannot sleep much and cannot sleep at all.|Week 52 or final evaluation (early discontinuation)|The FAS population included all participants with the exception of participants with violation of eligibility criteria, participants with no treatment with the patch of fentanyl and participants without efficacy data after initiation of patch application. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.||participants|||Number
781361|NCT00788372|Primary|Number of Participants With Total Painful Time Per Day|The participants assessed total painful time in 1 day by the following 5 grades: less than 4 hours, 4 hours to less than 8 hours, 8 hours to less than 12 hours, 12 hours or more and all day.|Week 52 or final evaluation (early discontinuation)|The FAS population included all participants with the exception of participants with violation of eligibility criteria, participants with no treatment with the patch of fentanyl and participants without efficacy data after initiation of patch application. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.||participants|||Number
781362|NCT00788372|Primary|Number of Participants With Pain Assessed by Categorical Scale for Pain|Pain intensity was measured by assessing the average intensity of pain experienced by the participant in daily living throughout the day by 4 grades: no pain at all, mild (slightly painful, but not worried), moderate (painful, but bearable) and severe (painful and unbearable).|Week 52 or final evaluation (early discontinuation)|The FAS population included all participants with the exception of participants with violation of eligibility criteria, participants with no treatment with the patch of fentanyl and participants without efficacy data after initiation of patch application. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.||participants|||Number
781363|NCT00788372|Primary|Pain Visual Analogue Scale Score|"Pain visual analog scale was used to assess the amount of pain experienced by the participant throughout the day by marking a slash through the line of a 100 millimeter (mm) scale measuring pain from no pain (0 mm) to worst possible pain (100 mm)."|Week 52 or end point (early discontinuation)|Full Analysis Set (FAS) population included all the participants with the exception of participants with violation of eligibility criteria, participants with no treatment with the patch of fentanyl and participants without efficacy data after initiation of patch application.||mm||Standard Deviation|Mean
781364|NCT00788372|Primary|Dependence Questionnaire (DQ)|The DQ is a clinician rated 5-item scale that evaluates dependence on drug and based on questions (Q). Based on participant's answer to Q in questionnaire, Investigator assessed whether drug dependence occurred. It comprises 5 Q which are: continuing drug for reason other than pain, using drug in more dosage than prescribed to have effect other than treatment of pain, have ever used drug with more dosage than prescribed for other purpose, anxiety with the thought of stopping drug for reason other than aggravation of symptoms by stopping this drug and feeling to violate law to get this drug.|Week 52 or end point (early discontinuation)|Safety population included all the participants who received at least one patch application of the investigational product. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.||units on a scale|||Number
781365|NCT00788372|Primary|Questionnaire of Opioid Withdrawal Symptoms|Questionnaire of opioid withdrawal symptoms is a clinician rated 11-item scale that primarily evaluates the physical components of opioid withdrawal and is based on questions and clinical observations. The total score of questionnaire of opioid withdrawal symptoms is the sum of all individual items, with less than (<) 5 points = no withdrawal, 5 to 12 points = mild withdrawal, 13 to 24 points = moderate withdrawal, 25 to 36 points = moderately severe withdrawal and greater than (>) 36 points = severe withdrawal.|Week 52 or endpoint (1 week after last treatment or early discontinuation)|Safety population included all the participants who received at least one patch application of the investigational product. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.||participants|||Number
781366|NCT00788593|Secondary|Change From Placebo Baseline in Body Mass Index (BMI) at End of Treatment|BMI was calculated by weight divided by height squared and measured as kilogram per square meter (kg/m^2). Mean change from baseline in BMI was calculated for end of treatment (6 days home treatment and 3-5 days hospital treatment) in first and second intervention periods.|Baseline, end of treatment (6 days home treatment and 3-5 days hospital treatment in first and second intervention periods)|"FAS included all participants who received at least one dose of the study medication. Here N (number of participants analyzed) represents number of participants who were evaluable for this outcome measure."||kg/m^2||Standard Deviation|Mean
781391|NCT00788957|Secondary|Part 2: Maximum Observed Drug Concentration During the Dosing Interval (Cmax) for Panitumumab||Pre-dose and 5 minutes after the completion of infusion at Weeks 1, 3, 5, 7, 13 and 23.|Part 2 participants with available pharmacokinetic data at each time point (indicated by n).||μg/mL||Standard Deviation|Mean
781367|NCT00788593|Secondary|Change From Placebo Baseline in Weight at End of Each Treatment Period|Mean change from baseline in weight was calculated for end of treatment (6 days home treatment and 3-5 days hospital treatment) in first and second intervention periods.|Baseline, end of treatment (6 days home treatment and 3-5 days hospital treatment in first and second intervention periods)|"FAS included all participants who received at least one dose of the study medication. Here N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure."||kilogram (kg)||Standard Deviation|Mean
781368|NCT00788593|Secondary|Change From Placebo Baseline in Percent Coefficient of Nitrogen Absorption (CNA) During Hospital Treatment|Percent CNA was calculated as [(nitrogen intake - nitrogen excretion)/nitrogen intake]*100 , determined in the stools collected during the 72-hour CNA determination period. Nitrogen intake was calculated as protein intake/6.2. Nitrogen excretion was measured as total fecal nitrogen. Mean percent CNA was calculated for 3 to 5 days of hospital treatment in first and second intervention periods.|Baseline, 3 to 5 days of hospital treatment in first and second intervention periods|"FAS included all participants who received at least one dose of the study drug. Here N (number of participants analyzed) represents number of participants who were evaluable for this outcome measure."||percent CNA||Standard Deviation|Mean
781369|NCT00788593|Secondary|Change From Placebo Baseline in Percent Coefficient of Fat Absorption (CFA) in High Dose EUR-1008 and Low Dose EUR-1008 During Hospital Treatment|Percent CFA was calculated as ([fat intake - fat excretion]/fat intake)*100, determined in the stools collected during the 72-hour CFA determination period. Mean percent CFA was calculated for 3 to 5 days of hospital treatment in first and second intervention periods.|Baseline, 3 to 5 days of hospital treatment in first and second intervention periods|"FAS included all participants who received at least 1 dose of the study medication. Here N (number of participants analyzed) signifies those participants for whom the CFA values were available."||percent CFA||Standard Deviation|Mean
781370|NCT00788593|Primary|Percent Coefficient of Fat Absorption (CFA) of Participants Treated With High Dose EUR-1008 and Low Dose EUR-1008|Percent CFA was calculated as ([fat intake - fat excretion]/fat intake)*100, determined in the stools collected during the 72-hour CFA determination period. Mean percent CFA was calculated for the 3 to 5 days of hospital treatment in first and second intervention periods.|3 to 5 days of hospital treatment in first and second intervention periods|"FAS included all participants who received at least 1 dose of the study medication. Here N (number of participants analyzed) signifies those participants for whom the CFA values were available."||percent CFA||Standard Deviation|Mean
781392|NCT00788957|Secondary|Part 1: Area Under the Drug Concentration-time Curve During a Dosing Interval (AUCtau) for Panitumumab and Rilotumumab||Week 5 (third dose) at pre-dose, 5 minutes after infusion and at 24, 48 and 96, and 168 hours post infusion.|Part 1 participants for whom intensive pharmacokinetic samples after the third dose (Week 5) were available.||day*μg/ml||Standard Deviation|Mean
781379|NCT00788710|Secondary|Average Elicited Pain Upon Sitting Over Days 1 to 3|Elicited pain upon sitting was measured on a 0- to 10-point scale: 0=no pain, to 10=pain as bad as you can imagine.|3 days|Full analysis set population||Score on a scale||Standard Error|Least Squares Mean
781380|NCT00788710|Secondary|Average Total Daily Dose of Morphine Over Days 1 to 3||3 days|Full analysis set population||milligrams (mg)||Standard Error|Least Squares Mean
781381|NCT00788710|Primary|Average Pain Intensity at Rest Over Days 1 to 3|Pain intensity at rest was measured on a 0- to 10-point scale: 0=no pain, to 10=pain as bad as you can imagine.|3 Days|Full analysis set population||Score on a scale||Standard Error|Least Squares Mean
781382|NCT00788775|Secondary|Best Overall Response|Best overall response (BOR) on treatment was based on RECIST 1.0 criteria. For target lesions, complete response (CR) is complete disappearance of all target lesions and partial response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. CR or PR confirmation required within 4 weeks. Progressive disease (PD) is at least a 20% increase in the sum LD of target lesions from smallest sum LD as reference or the appearance of one or more new lesions. Stable disease (SD) is neither meeting PR or PD. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions. CR is disappearance of all non-target lesions.|Disease was evaluated radiologically at baseline and every 8 weeks on treatment and long-term every 3 months until first progression, death or lost to follow-up. Mean treatment duration was 5.5 months (range 0-45; no/with CNS mets 7.4m/ 3m).|||participants|||Number
781383|NCT00788775|Secondary|Overall Survival|Overall survival (OS) is defined as the time from study entry to death or date last known alive.|Patients were followed long-term every 3 months until first progression, death or lost to follow-up. Median survival follow-up was 16.2 months (90%CI 11.7-17.7 months; no/with CNS mets 16.2m/ 11.7m).|The analysis dataset is comprised of treated patients.||months||90% Confidence Interval|Median
781384|NCT00788775|Secondary|Progression-Free Survival|Progression-free survival (PFS) based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study or death. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.|Disease was evaluated radiologically at baseline and every 8 weeks on treatment and long-term every 3 months until first progression, death or lost to follow-up. Mean treatment duration was 5.5 months (range 0-45; no/with CNS mets 7.4m/ 3m).|The analysis dataset is comprised of treated patients.||months||90% Confidence Interval|Median
781385|NCT00788775|Primary|4-month Progression-Free Survival Rate|4-month progression-free survival rate was defined as the proportion of patients absent death or progression based on Response Evaluation Criteria In Solid Tumors Criteria (RECIST) before 4 months. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.|Disease was evaluated radiologically at baseline and every 8 weeks on treatment; Treatment continued for 12 months unless disease progression or unacceptable toxicity. Relevant for this endpoint was disease status at 4 months.|The analysis dataset is comprised of treated patients.||proportion of patients||90% Confidence Interval|Number
781386|NCT00788957|Secondary|Part 2: Minimum Observed Drug Concentration During the Dosing Interval (Cmin) for Ganitumab|Concentration represents the Cmin from the previous dose (eg, Week 3 Cmin is the Cmin after the 1st dose).|Pre-dose at Weeks 3, 5, 7, 13 and 23.|Part 2 participants with available pharmacokinetic data at each time point (indicated by n).||μg/mL||Standard Deviation|Mean
781387|NCT00788957|Secondary|Part 2: Maximum Observed Drug Concentration During the Dosing Interval (Cmax) for Ganitumab||Pre-dose and 5 minutes after the completion of infusion at Weeks 1, 3, 5, 7, 13 and 23.|Part 2 participants with available pharmacokinetic data at each time point (indicated by n).||μg/mL||Standard Deviation|Mean
781388|NCT00788957|Secondary|Part 2: Minimum Observed Drug Concentration During the Dosing Interval (Cmin) for Rilotumumab|Concentration represents the Cmin from the previous dose (eg, Week 3 Cmin is the Cmin after the 1st dose).|Pre-dose at Weeks 3, 5, 7, 13 and 23.|Part 2 participants with available pharmacokinetic data at each time point (indicated by n).||μg/mL||Standard Deviation|Mean
781389|NCT00788957|Secondary|Part 2: Maximum Observed Drug Concentration During the Dosing Interval (Cmax) for Rilotumumab||Pre-dose and 5 minutes after the completion of infusion at Weeks 1, 3, 5, 7, 13 and 23.|Part 2 participants with available pharmacokinetic data at each time point (indicated by n).||μg/mL||Standard Deviation|Mean
781390|NCT00788957|Secondary|Part 2: Minimum Observed Drug Concentration During the Dosing Interval (Cmin) for Panitumumab|Concentration represents the Cmin from the previous dose (eg, Week 3 Cmin is the Cmin after the 1st dose).|Pre-dose at Weeks 3, 5, 7, 13 and 23.|Part 2 participants with available pharmacokinetic data at each time point (indicated by n).||μg/mL||Standard Deviation|Mean
781394|NCT00788957|Secondary|Number of Participants With Antibody Formation to Panitumumab, Rilotumumab and Ganitumab|Validated immunoassays were used to detect anti-panitumumab, anti-rilotumumab and anti-ganitumab binding antibodies.|From the first dose date to 30 days after the last dose of study drug, up to the data cutoff date of 08 February 2012. Median time on treatment was 5.2 months for Part 1, 2.8, 3.9 and 4.2 months for each Part 2 treatment arm respectively.|Safety analysis set participants with at least one post-baseline immunoassay result.||participants|||Number
781395|NCT00788957|Secondary|Number of Participants With Grade 3 or Higher Laboratory Toxicities|The severity of laboratory toxicities was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) version 3: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Fatal.|From the first dose date to 30 days after the last dose of study drug, up to the data cutoff date of 08 February 2012. Median time on treatment was 5.2 months for Part 1, 2.8, 3.9 and 4.2 months for each Part 2 treatment arm respectively.|Safety analysis set (all enrolled participants who received at least 1 dose of investigational product).||participants|||Number
781396|NCT00788957|Secondary|Number of Participants With Adverse Events (AEs)|A serious adverse event (SAE) is defined as an AE that is fatal, life threatening (places the participant at immediate risk of death), requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or other significant medical hazard. AEs were graded for severity according to the National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) version 3: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Fatal. AEs were assessed by the investigator for the relationship of the AE to each one or more of the investigational products by the question: “Is there a reasonable possibility that the event may have been caused by the investigational product?”|From the first dose date to 30 days after the last dose of study drug, up to the data cutoff date of 08 February 2012. Median time on treatment was 5.2 months for Part 1, 2.8, 3.9 and 4.2 months for each Part 2 treatment arm respectively.|Safety analysis set (all enrolled participants who received at least 1 dose of investigational product).||participants|||Number
781397|NCT00788957|Secondary|Overall Survival|The interval from the first dose of study therapy to the date of death. Participants still alive at the analysis data cutoff date were censored at their last contact date.|From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.|Efficacy analysis set||months||95% Confidence Interval|Median
781398|NCT00788957|Secondary|On-treatment Progression-free Survival|An event is defined as a radiographic progression or death that occurred from the first dose to 28 days since the last dose of study therapy. Participants who did not progress or die during this period were censored at their last evaluable disease assessment before the end of the 28-day period. Participants who received Part 3 treatment before 28 days since their last dose of study drug in Part 2 and did not have radiographic progression or die were censored at their last evaluable disease assessment prior to receiving therapy in Part 3. Radiographic progressions after start of a new anti-tumor therapy, including Part 3 treatment, or after 28 days since the last dose in Part 2 were excluded from the analysis. Participants who died with no prior radiographic disease progression during Part 3 treatment, but within the 28-day period since the last dose in Part 2 were considered as having an event.|From the date of first dose until 28 days after the last dose until the data cut-off date of 23 July 2010. Median time on treatment was 3.7, 4.9 and 5.1 months in each treatment arm respectively.|Efficacy analysis set||months||95% Confidence Interval|Median
781399|NCT00788957|Secondary|Progression-free Survival|The interval from the first dose of study therapy to the earlier date of disease progression (per modified-RECIST v1.0) or death. Participants who did not progress or die by the analysis data cutoff date were censored at their last evaluable disease assessment date prior to the earlier of the analysis data cutoff date, initiating a new line of anti-tumor therapy, and receiving study treatment in Part 3 where applicable. Participants enrolled into Part 3 or who started a new line of anti-tumor therapy before radiographic progression but subsequently died were considered as having an event with the event date same as the death date.|From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.|Efficacy analysis set||months||95% Confidence Interval|Median
781400|NCT00788957|Secondary|Part 2: Percentage of Participants With Disease Control|The percentage of participants with an overall objective response of CR, PR, or stable disease (SD). CR: Disappearance of all target and non-target and no new lesions. PR: At least a 30% decrease in the size of target lesions with no increase in non-target lesions, or, the disappearance of all target lesions and persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease (PD). SD: Neither sufficient shrinkage of target lesions to qualify for PR nor sufficient increase to qualify for PD and no progression of non-target lesions, or the persistence of one or more non-target lesion(s) not qualifying for either CR or PD.|From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.|Efficacy analysis set||percentage of participants||95% Confidence Interval|Number
781401|NCT00788957|Secondary|Part 2: Time to Response|The interval from the first dose of study therapy to the date of the first confirmed objective response, calculated only for participants with an objective response.|From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.|Efficacy analysis set; participants with an objective response of CR or PR.||months||95% Confidence Interval|Median
781402|NCT00788957|Secondary|Part 2: Duration of Response|The interval from the first visit of a confirmed objective response to disease progression as defined by the modified RECIST v1.0 criteria. Participants who did not progress by the earlier of the analysis data cutoff date, initiating a new line of anti-tumor therapy, and the start of Part 3 dosing where applicable were censored at their last evaluable disease assessment date prior to the end of reporting period. Progressive disease is defined as at least a 20% increase in the size of target lesions, or unequivocal progression of existing non-target lesions, or any new lesions.|From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.|Efficacy analysis set; participants with an objective response of CR or PR.||months||95% Confidence Interval|Median
781432|NCT00794664|Other Pre-specified|Triglycerides at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||mg/dL||Standard Deviation|Mean
781403|NCT00788957|Primary|Part 2: Percentage of Participants With an Objective Response|An objective response is defined as a confirmed complete (CR) or partial response (PR) no less than 4 weeks after the criteria for response are first met, determined by the investigator considering the radiologic response of all existing target and non-target lesions, evidence of new lesions, and cytology evaluation (as appropriate) according to the Modified-Response Evaluation Criteria In Solid Tumors (RECIST) v1.0 criteria: CR: Disappearance of all target and non-target and no new lesions. PR: At least a 30% decrease in the size of target lesions with no increase in non-target lesions, or, the disappearance of all target lesions and persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease. Participants without a post-baseline assessment were considered non-responders. Tumor assessments up to the initiation of another anti-tumor therapy including the Part 3 treatment, if applicable, were used.|From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.|Efficacy analysis set (enrolled participants who received at least one dose of respective investigational product in the corresponding parts of the study) with measurable baseline disease.||percentage of participants|||Number
781404|NCT00788957|Primary|Part 1: Number of Participants With Dose-limiting Toxicities (DLT)|A DLT is defined as any grade 3 or 4 rilotumumab-related or combination (panitumumab and rilotumumab)-related adverse event or laboratory abnormality that is deemed clinically significant by the investigator|7 weeks|The first 6 DLT evaluable participants, including participants who received at least 2 doses of panitumumab and rilotumumab as scheduled (ie, Week 1 and 3) and have a minimum 28 days follow-up for safety or, have received at least 1 dose of panitumumab and rilotumumab and had a DLT within the first 28 days on study.||participants|||Number
781405|NCT00794365|Primary|Percentage of Participants With 7-day Point Prevalence of Smoking Cessation at Week 12|Participants who abstained from smoking in last 7 days. Abstained = response of no to both Nicotine Use Inventory questions: “In last 7 days has subject 1) smoked any cigarettes (even a puff)?, and 2) used any other nicotine-containing products?”. Participants who discontinued study were counted as a smoker for the 7-day point prevalence from the timepoint of discontinuation through end of study.|Week 12|Intent-to-Treat (ITT): participants who took at least 1 dose of varenicline tablets.||percentage of participants||95% Confidence Interval|Number
781406|NCT00794365|Primary|Percentage of Participants With 7-day Point Prevalence of Smoking Cessation at Week 8|Participants who abstained from smoking in last 7 days. Abstained = response of no to both Nicotine Use Inventory questions: “In last 7 days has subject 1) smoked any cigarettes (even a puff)?, and 2) used any other nicotine-containing products?”. Participants who discontinued study were counted as a smoker for the 7-day point prevalence from the timepoint of discontinuation through end of study.|Week 8|Intent-to-Treat (ITT): participants who took at least 1 dose of varenicline tablets.||percentage of participants||95% Confidence Interval|Number
781407|NCT00794365|Primary|Percentage of Participants With 7-day Point Prevalence of Smoking Cessation at Week 4|Participants who abstained from smoking in last 7 days. Abstained = response of no to both Nicotine Use Inventory questions: “In last 7 days has subject 1) smoked any cigarettes (even a puff)?, and 2) used any other nicotine-containing products?”. Participants who discontinued study were counted as a smoker for the 7-day point prevalence from the timepoint of discontinuation through end of study.|Week 4|Intent-to-Treat (ITT): participants who took at least 1 dose of varenicline tablets.||percentage of participants||95% Confidence Interval|Number
781408|NCT00794469|Primary|Baseline Metabolic Rate|baseline metabolic rate|baseline|||kcal/d||Standard Deviation|Mean
781409|NCT00794469|Primary|Post-drinking Metabolic Rate|resting metabolic rate after drinking water|1 hour|||kcal/d||Standard Deviation|Mean
781410|NCT00794508|Secondary|Number of Participants Reaching the Normal Range of ADA Enzyme Activity|As measured by ADA enzyme activity in peripheral blood mononuclear cells|2 years|||participants|||Number
781411|NCT00794508|Secondary|Number of Participants With Greater Than 1% of Gene-Modified Cells in the Peripheral Blood|As measured by quantitative polymerase chain reaction in peripheral blood cells separated into mononuclear and granulocyte fractions.|2 years|||participants|||Number
781412|NCT00794508|Primary|Number of Participants With Adverse Events|"Examine the safety of the procedure: harvesting bone marrow, isolating CD34+ hematopoietic stem/progenitor cells, performing ex vivo gene transduction with the MND-ADA gamma-retroviral vector, giving 90 mg/m2 busulfan to make space in the bone marrow to aid engraftment, and re-infusing the autologous gene-modified cells."|2 years|||participants|||Number
781413|NCT00794547|Primary|Median Overall Survival|The second primary objective was to characterize the toxicity and response of patients treated with a combination of calcitriol, cisplatin and docetaxel. To assess the response, overall survival was determined.|5 years|22 patients were treated at the Maximum Tolerated Dose, including 6 phase I patients who received the MTD during the phase 1 component. 1 of 6 phase 1 patients was not evaluable due to toxicity. 1 patient (of 16) in the phase 2 study went to another therapy prior to the 30 day window and was excluded from analysis. 20 patients were analyzed.||months||95% Confidence Interval|Median
781414|NCT00794547|Primary|Median Time to Progression|The second primary objective was to characterize the toxicity and response of patients treated with a combination of calcitriol, cisplatin and docetaxel. To assess the response, median time to progression was determined. Progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.|5 years|22 patients were treated at the Maximum Tolerated Dose, including 6 phase I patients who received the MTD during the phase 1 component. 1 of 6 phase 1 patients was not evaluable due to toxicity. 1 patient (of 16) in the phase 2 study went to another therapy prior to the 30 day window and was excluded from analysis. 20 patients were analyzed.||months||95% Confidence Interval|Median
781415|NCT00794547|Primary|Number of Participants That Experience Grade 3 or Greater Neutropenia|The second primary objective was to characterize the toxicity and response of patients treated with a combination of calcitriol, cisplatin and docetaxel. Toxicity was assessed, in part, by noting the number of participants that experience grade 3 or greater neutropenia in each phase of the trial. Toxicities were recorded using NCI CTCAE (Common Terminology Criteria for Adverse Events) version 3.0 and were followed for 30 days after the date of withdrawal from study drug.|30 days after last dose|Thirty-four patients were enrolled (18 in phase I and 16 in phase II). 16 of 18 patients enrolled in the Phase 1 portion of the study were evaluable for toxicity. One patient in the phase II study went to another therapy prior to the 30 day window for a confirmatory scan and was thus excluded from analysis.||participants|||Number
781418|NCT00794547|Primary|MTD of Intravenous Calcitriol When Administered Prior to Fixed Dose Cisplatin 75mg/m2 and Docetaxel 75 mg/m2, Every 3 Weeks in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)|The primary objective was to determine the Maximum Tolerated Dose (MTD) of intravenous calcitriol when administered prior to fixed dose cisplatin 75mg/m2 and docetaxel 75 mg/m2, every 3 weeks in patients with advanced non-small cell lung cancer (NSCLC). Accrual duration for the study is 5 years.|5 years|Eighteen patients were enrolled, and 16 were evaluable for toxicity assessments. Two patients were not evaluable as they progressed prior to completion of cycle 1.||mcg/m^2|||Number
781419|NCT00794560|Secondary|Patient Satisfaction||at the end of the individual drug therapy, an average of 18 days||||||
781420|NCT00794560|Secondary|Compliance|objectively determined by syringe count Therapy durations varied individually depending on the indication of the drug therapy (days to weeks).|at the end of the individual drug therapy, an average of 18 days|||percentage of syringes||Standard Deviation|Mean
781421|NCT00794560|Primary|Drug Use Problems|During a home visit and at her/his individual injection time, each patient was monitored when self-administering an s.c. injection (directly observed therapy, DOT). Score minimum = -2.00; score maximum = +2.00 for the objective estimation of the application quality. Higher score values represent better outcomes.|during the individual drug therapy, an average of 18 days|||scores on a scale||Standard Deviation|Mean
781422|NCT00794664|Other Pre-specified|HDL-C at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||mg/dL||Standard Deviation|Mean
781423|NCT00794664|Other Pre-specified|Percentage Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Primary Efficacy Time Point (PET)|HDL-C was measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||percentage of baseline||Standard Deviation|Mean
781424|NCT00794664|Other Pre-specified|Apo-A1 at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||mg/dL||Standard Deviation|Mean
781425|NCT00794664|Other Pre-specified|Percent Change From Baseline in Apolipoprotein A1 (Apo-A1) at Primary Efficacy Time Point (PET)|Apo-A1 was measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||percentage of baseline||Standard Deviation|Mean
781426|NCT00794664|Other Pre-specified|Ratio of LDL-C to HDL-C at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||ratio||Inter-Quartile Range|Median
781427|NCT00794664|Other Pre-specified|Change From Baseline in Ratio of Low-density Lipoprotein Cholesterol (LDL-C) to High-density Lipoprotein Cholesterol (HDL-C) at Primary Efficacy Time Point (PET)|LDL-C and HDL-C were measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||percentage of baseline||Inter-Quartile Range|Median
781428|NCT00794664|Other Pre-specified|VLDL-C at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||mg/dL||Standard Deviation|Mean
781429|NCT00794664|Other Pre-specified|Percentage Change From Baseline in Very-Low-Density Lipoprotein Cholesterol (VLDL-C) at Primary Efficacy Time Point (PET)|VLDL-C was measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||percentage of baseline||Standard Deviation|Mean
781430|NCT00794664|Other Pre-specified|Lipoprotein(a) at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||mg/dL||Standard Deviation|Mean
781431|NCT00794664|Other Pre-specified|Percentage Change From Baseline in Lipoprotein(a) at Primary Efficacy Time Point (PET)|Lipoprotein(a) was measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||percentage of baseline||Standard Deviation|Mean
781433|NCT00794664|Other Pre-specified|Percentage Change From Baseline in Triglycerides at Primary Efficacy Time Point (PET)|Triglycerides were measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||percentage of baseline||Standard Deviation|Mean
781434|NCT00794664|Secondary|Non-HDL-C at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||mg/dL||Standard Deviation|Mean
781435|NCT00794664|Secondary|Percentage Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Primary Efficacy Time Point (PET)|Non-HDL-C was measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||percentage of baseline||Standard Deviation|Mean
781436|NCT00794664|Secondary|Total Cholesterol at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||mg/dL||Standard Deviation|Mean
781437|NCT00794664|Secondary|Percentage Change From Baseline in Total Cholesterol at Primary Efficacy Time Point (PET)|Total cholesterol was measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||percentage of baseline||Standard Deviation|Mean
781438|NCT00794664|Secondary|Apo-B at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||mg/dL||Standard Deviation|Mean
781439|NCT00794664|Secondary|Percent Change From Baseline in Apolipoprotein B (Apo-B) at Primary Efficacy Time Point|Apo-B was measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||percentage of baseline||Standard Deviation|Mean
781440|NCT00794664|Primary|LDL-C at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||mg/dL||Standard Deviation|Mean
781441|NCT00794664|Primary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Primary Efficacy Time Point|LDL-C was measured in mg/dL. Samples were taken following an overnight fast. For patients with triglycerides <400 mg/dL, LDL-C was obtained using Friedewald’s calculation; and for patients with triglycerides >=400 mg/dL, LDL-C was directly measured by the central laboratory using ultracentrifugation. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set (FAS). The FAS, which represents the practically-feasible intent-to-treat (ITT) population as delineated in ICH Guideline E9, consists of treated participants with a valid baseline and at least one post-baseline LDL-C measure.||percentage of baseline||Standard Deviation|Mean
781442|NCT00794677|Other Pre-specified|Percent Change of Non-high Density Lipoprotein Cholesterol||Fasting measurements after 6 weeks on ezetimibe vs placebo|Per protocol||percent||Standard Error|Mean
781443|NCT00794677|Other Pre-specified|Percent Change in High Density Lipoprotein Cholesterol||Fasting measurements after 6 weeks on ezetimibe vs placebo|Per protocol||percent||Standard Error|Mean
781444|NCT00794677|Other Pre-specified|Percent Change of Low Density Lipoprotein Cholesterol||Fasting measurements after 6 weeks on ezetimibe vs placebo|Per protocol||percent||Standard Error|Mean
781445|NCT00794677|Other Pre-specified|Percent Change of Apolipoprotein B||Fasting measurements after 6 weeks on ezetimibe vs placebo|Per protocol||percent||Standard Error|Mean
781446|NCT00794677|Other Pre-specified|Log (AUC of Plasma Triglyceride) After an Oral Bolus||Over 8 hours after 6 weeks of treatment with ezetimibe or placebo|Per protocol, one subject eliminated because the AUC was negative and cannot be log transformed||Log(mg/dl)||Standard Error|Mean
781447|NCT00794677|Other Pre-specified|Log (AUC of Plasma Total Cholesterol) After an Oral Bolus||Over 8 hours after 6 weeks of treatment with ezetimibe or placebo|Per protocol, restricted to changes that were nonnegative because there is no log for a negative number||Log(mg/dl)||Standard Error|Mean
781448|NCT00794677|Other Pre-specified|Log(Fasting Plasma Levels of Diet-derived Oxysterols (7-ketocholesterol))||Fasting measurements after 6 weeks on ezetimibe vs placebo|Per protocol||Log(mg/dl)||Standard Error|Mean
781450|NCT00794677|Primary|Log[Area-under-the-plasma-concentration-curve(AUC) 0-8 Hours 7-ketocholesterol] After an Oral Bolus|Log of Area-under-the-plasma-concentration curve (AUC 0-8hrs) of 7-ketocholesterol after an oral bolus in patients with primary hypercholesterolemia after treatment with ezetimibe versus placebo|Over 8 hours after 6 weeks of treatment with ezetimibe or placebo|per protocol||Log(mg/dl)||Standard Error|Mean
781451|NCT00794820|Secondary|Overall Survival (OS) Rate|OS was defined as the time from the initiation of treatment to last follow-up date or death. OS were calculated using Kaplan-Meier estimates, and survival estimates were compared among subgroups of participants using the log-rank test.|6 months to disease progression, period covered up to 12 years following treatment; Data cutoff for analysis was October 2014.|One of the 65 participants is not included in analysis, the participant went off study after two months of treatment.||Percentage of Participants|||Number
781452|NCT00794820|Secondary|Remission Duration/Time to Progression (TTP)|TTP was defined as time from initiation of treatment to primary refractory disease or CLL progression. TTP was censored for therapy-related myelodysplastic syndrome (t-MDS) or acute myelogenous leukemia (t-AML) and death in remission. TTP calculated using Kaplan-Meier estimates.|6 months to disease progression, period covered up to 12 years following treatment; Data cutoff for analysis was October 2014.|One of the 65 participants was not assessed for response to therapy therefore is not included in analysis. The participant went off study after two months of treatment and was not evaluable for response.||Months||Full Range|Median
781453|NCT00794820|Primary|Complete Remission (CR) Rate of FCR3 in Treatment-naïve Participants With Chronic Lymphocytic Leukemia (CLL) at 6 Months|CR Rate is defined as number of all treated participants with CR as defined by 2008 IWCLL update of NCI-WG response criteria: Complete remission (CR), requiring absence of peripheral blood clonal lymphocytes by immunophenotyping, absence of lymphadenopathy, absence of hepatomegaly or splenomegaly, absence of constitutional symptoms and satisfactory blood counts; Complete remission with incomplete marrow recovery (CRi), defined as CR above, but without normal blood counts; Partial remission (PR), defined as ≥ 50% fall in lymphocyte count, ≥ 50% reduction in lymphadenopathy or ≥ 50% reduction in liver or spleen, together with improvement in peripheral blood counts; Progressive disease (PD): ≥ 50% rise in lymphocyte count to > 5 x109/L, ≥ 50% increase in lymphadenopathy, ≥ 50% increase in liver or spleen size, Richter’s transformation, or new cytopenias due to CLL; Stable disease, defined as not meeting criteria for CR, CRi, PR or PD.|6 months|One of the 65 participants was not assessed for response to therapy therefore is not included in analysis. The participant went off study after two months of treatment and was not evaluable for response.||Percentage of Participants|||Number
781454|NCT00794924|Secondary|Improvement in Nutritional and Immunological Measurements||45 days||||||
781455|NCT00794924|Primary|Reduction in Number of Days of Either Constipation or Diarrhea in Comparison to the Control Group|Gastrointestinal motility was assessed by the number of days a patient was constipated or had diarrhea.|45 days of measuring the outcome|The number of participants was chosen in order to receive a difference by GEE statistical model with > 0.05 p value. The analysis was done per protocol.||days of constipation or diarrhea||Standard Deviation|Mean
781456|NCT00794963|Primary|Change in Weight||baseline and 8 months|4 participants in usual care arm did not return for follow-up and were not available for analysis; 1 participant in the integrated care group was lost to follow-up||pounds||Standard Deviation|Mean
781457|NCT00795002|Secondary|Disease-free Survival|This will be defined as the time between study entry and the first date that recurrent or progressive disease is objectively documented, or death from any cause occurs.|12 months||||||
781458|NCT00795002|Secondary|Toxicity|as assessed by NCI CTCAE v3.0|1 year||||||
781459|NCT00795002|Primary|Complete Response|Bone marrow showing less than 5% leukemic blasts with normal maturation of all cell lines, an ANC of at least 1000/uL and a platelet count of 100,000/uL, absence of blast in peripheral blood, absence of identifiable leukemic cells in the bone marrow, clearance of disease-associated cytogenetic abnormalities, and clearance of any previously existing extramedullary disease. Repeat marrow confirmation 4-6 weeks following the marrow documenting CR is not required due to the need for continued treatment in CR.|1 year|39 patients had been enrolled in each arm with two patients in each arm receiving incomplete therapy||participants|||Number
781460|NCT00795132|Secondary|Number of Participants Who Experienced Transplantation-related Mortality (TRM)|Cumulative incidence transplantation-related mortality (TRM)|24 months|All incidences of enrolled patients were analyzed.||participants|||Number
781461|NCT00795132|Secondary|Two Year Overall Survival|The probability that a given patient will be alive two years after transplantation.|24 months|All enrolled participants were analyzed.||probability||Standard Error|Mean
781462|NCT00795132|Primary|Number of High Risk Pediatric Patients With Successful Sustained Donor Engraftments|Assessed donor engraftment in very high risk pediatric patients.|24 months|All enrolled patients were analyzed except for the 3 patients who relapsed or died prior to engraftment.||participants|||Number
781463|NCT00795145|Secondary|Cohort 2: Number of Subjects With AEs and SAEs|All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product(s) were reported.|From the time the subject had taken at least one dose of study treatment up to 5 weeks|SAS||participants|||Number
781464|NCT00795145|Secondary|Cohort 2: Vss|Vss = (mean residence time [The average total time molecules of a given dose spend in the body] extrapolated to infinity) multiplied by CL|Predose, 30 minutes, 1, 2, 4, 8, 12 hours post-dose|PK parameter analysis population||L/kg||Standard Deviation|Mean
781465|NCT00795145|Secondary|Cohort 2: CL|Drug clearance = Dose / AUC inf|Predose, 30 minutes, 1, 2, 4, 8, 12 hours post-dose|PK parameter analysis population||mL/min/kg||Standard Deviation|Mean
781466|NCT00795145|Secondary|Cohort 2: Tmax and t1/2|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Tmax is the time to reach Cmax.|Predose, 30 minutes, 1, 2, 4, 8, 12 hours post-dose|PK parameter analysis population||hr||Full Range|Median
781467|NCT00795145|Secondary|Cohort 2: Cmax||Predose, 30 minutes, 1, 2, 4, 8, 12 hours post-dose|PK parameter analysis population||ug/mL||Standard Deviation|Mean
781468|NCT00795145|Secondary|Cohort 2: AUC Inf and AUC Last|"AUC inf = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time.
AUC last = Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)."|Predose, 30 minutes, 1, 2, 4, 8, 12 hours post-dose|PK parameter analysis population||ug *hr/mL||Standard Deviation|Mean
781471|NCT00795145|Primary|Cohort 2: Mean Time-Matched Difference in Time Corresponding to Beginning of Depolarization to Repolarization of the Ventricles, Corrected for Heart Rate Using Fridericia's Formula (QTcF Interval) Between Linezolid 600 mg and 1200 mg Compared to Placebo|The time corresponding to the beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for ventricular rate (VR) using the QT and VR from each electrocardiogram by Fridericia’s formula (QTcF = QT divided by cube root of VR in seconds). A measure of dispersion is not available.|0.5, 1, 2, 4, 8, 12, 24 hours post-dose|The pharmacokinetic (PK) parameter analysis population was defined as all subjects randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||milliseconds (msec)|||Number
781472|NCT00795145|Secondary|Cohort 1: Steady-State Volume of Distribution (Vss)|Vss = (mean residence time [The average total time molecules of a given dose spend in the body] extrapolated to infinity) multiplied by CL|predose, 30 minutes, and at 1 (end of infusion), 1.5, 2, 3, 4, 6, 8, 12, 24, and 46 hours after start of infusion|PK parameter analysis population||L/kg||Standard Deviation|Mean
781473|NCT00795145|Secondary|Cohort 1: Clearance of Linezolid (CL)|Drug clearance = Dose / AUC inf|predose, 30 minutes, and at 1 (end of infusion), 1.5, 2, 3, 4, 6, 8, 12, 24, and 46 hours after start of infusion|PK parameter analysis population||mL/minute (min)/kilogram (kg)||Standard Deviation|Mean
781474|NCT00795145|Secondary|Cohort 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) and Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|predose, 30 minutes, and at 1 (end of infusion), 1.5, 2, 3, 4, 6, 8, 12, 24, and 46 hours after start of infusion|PK parameter analysis population||hr||Full Range|Median
781475|NCT00795145|Secondary|Cohort 1: Maximum Observed Plasma Concentration (Cmax)||predose, 30 minutes, and at 1 (end of infusion), 1.5, 2, 3, 4, 6, 8, 12, 24, and 46 hours after start of infusion|PK parameter analysis population||ug/mL||Standard Deviation|Mean
781476|NCT00795145|Secondary|Cohort 1: Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC Inf) and Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC Last)|"AUC inf = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time.
AUC last = Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)."|predose, 30 minutes, and at 1 (end of infusion), 1.5, 2, 3, 4, 6, 8, 12, 24, and 46 hours after start of infusion|PK parameter analysis population||microgram (ug)*hours (hr)/mL||Standard Deviation|Mean
781477|NCT00795145|Primary|Cohort 1: Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)|All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product(s) were reported.|From the time the subject had taken at least one dose of study treatment up to 5 weeks|Safety Analysis Set (SAS): All subjects who received at least 1 dose of study medication.||participants|||Number
781478|NCT00795184|Primary|Comparative Histopathology-confirmed Measures of Per Lesion Sensitivity and Per Lesion Specificity, by Using pCLE Associated With WLE, or WLE Alone, for the Detection of High Grade Dysplasia and Early Carcinoma in Barrett’s Esophagus.|Comparative Histopathology-confirmed Measures of Per Lesion Sensitivity and Per Lesion Specificity, by Using Probe-based Confocal Laser Endomicroscopy (pCLE) Associated With White Light Endoscopy (WLE), or WLE Alone, for the Detection of High Grade Dysplasia and Early Carcinoma in Barrett’s Esophagus.|Centralized histopathology confirmation within 4-6 weeks|||percentage of lesions|Participants|95% Confidence Interval|Number
781479|NCT00795210|Secondary|Insulin Sensitivity|"insulin-stimulated glucose uptake as measured by euglycemic hyperinsulinemic clamp; M value (infusion rate with space correction, using method of DeFronzo) for the steady state between 100-120 minutes of clamp is given"|after two weeks treatment|Insulin stimulated glucose uptake data were unavailable for 4 subjects in the GH 2mg group. Two subjects did not have sufficient IV access and thus could not complete the clamp procedure. Two subjects did not reach target glucose and thus their data could not be used.||mg/kg/min||Standard Deviation|Mean
781480|NCT00795210|Primary|Overnight Mean Growth Hormone Secretion After 2 Weeks of Study Drug|Serum was sampled for growth hormone concentrations every 20 minutes between 20:00 (8pm) and 07:40 (7:40am). Subjects in GH 6mcg/kg/day and GH 2mg daily groups received their final dose of study drug approximately 36 hours prior to start of sampling. Subjects in Growth Hormone Releasing Hormone group received their final dose of study drug approximately 8 hours prior to start of sampling.|after 2 weeks treatment|Overnight GH data were unavailable for 1 subject in the GH 6mcg/kg group and thus are not included in analysis.||ng/mL||Inter-Quartile Range|Median
781481|NCT00795288|Secondary|Impact of Statin on Oxygen Extraction Fraction and Cerebral Metabolism During Peak Period of Vasospasm Risk|Oxygen extraction fraction (OEF) is the ratio of Oxygen delivery (ml/100 g/min) and oxygen utilization (ml/100 g/min). It describes the fraction of the oxygen that reaches the brain that it actually uses for energy production.|7-10 days after hemorrhage|||ratio||Standard Deviation|Mean
781482|NCT00795288|Primary|Cerebral Autoregulation During Peak Period of Vasospasm Risk|Fraction of patients with impaired static autoregulation (% change in MAP/% change in CVR) * 100 A value of <60 is considered abnormal.|7-10 days after hemorrhage|||participants|||Number
781483|NCT00795288|Primary|Resting Cerebral Blood Flow During Peak Period of Vasospasm Risk|Resting cerebral blood flow during peak period of vasospasm risk measured by PET|7-10 days after hemorrhage|"Of the total population enrolled complete data sets were available on 25. This was due to patient refusal to perform the PET study, logistical difficulties and technical problems.
be completed in seven due to logistical difficulties (n = 4) or patient refusal (n = 3). Two of the completed studies could not be analyzed for technical reasons"||mL/100 g/min||Standard Deviation|Mean
781484|NCT00795340|Secondary|Objective Tumor Response as Assessed by RECIST Criteria v1.1.|Every 6 weeks at the end of every 2 cycles during protocol treatment and every 12 weeks after protocol treatment until progression.|Every 6 weeks at the end of every 2 cycles during protocol treatment and every 12 weeks after protocol treatment until progression.|ITT||percentage of participants||95% Confidence Interval|Number
781485|NCT00795340|Secondary|Progression-free Survival|Medians of PFS and their confidence intervals by arm|at every 3 months visit throughout trial, a median of 12 months|ITT||months||95% Confidence Interval|Median
781486|NCT00795340|Primary|Overall Survival|Medians of survival time, and their confidence intervals.|at every 3 months visit throughout trial, a median of 13.1 months.|ITT||months||95% Confidence Interval|Median
781488|NCT00795509|Primary|Confirmation of the Incidence of All Treatment Related Adverse Events (TRAEs).|All observed or volunteered adverse events and the investigator’s opinion of the causal relationship to the study treatment were reported. Definition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product.|52 weeks|Safety analysis population included all enrolled participants who had received at least 1 confirmed, administration of Detorsitol.||participants|||Number
781489|NCT00795509|Primary|Adverse Drug Reaction Not Expected From the Japanese Package Insert. Number of Unlisted Treatment Related Adverse Events (TRAEs).|All observed or volunteered adverse events and the investigator’s opinion of the causal relationship to the study treatment were reported. Definition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert.|52 weeks|Safety analysis population included all enrolled participants who had received at least 1 confirmed, administration of Detorsitol.||participants|||Number
781490|NCT00795535|Primary|SDNN: Standard Deviation of the Normal-to-normal R-R Interval|A determination of HRV derived from the time domain of a standard electrocardiogram, primarily determined by measuring the randomness of the exact occurrence of when one R wave follows a preceding R wave.|Upon arrival to the hospital|||milliseconds (ms)||Standard Deviation|Mean
781491|NCT00795535|Primary|Life Saving Intervention in the Operating Room.|A patient was classified as having a life saving intervention in the operating room when two of three blinded trauma surgeons classified the patient as similar after review of each patient chart and final diagnoses in retrospect.|Upon arrival to the hospital|75 patients with complete HRV and trauma registry data||participants|||Number
781492|NCT00795535|Primary|Serious Injury|A patient was classified as seriously injured when two of three blinded trauma surgeons classified the patient as similar after review of each patient chart and final diagnoses in retrospect.|Upon arrival to the hospital|75 patients with complete HRV and trauma registry data||participants|||Number
781493|NCT00795535|Primary|Base Deficit </= -6|Indicator for volume deficit and resuscitation. Number of participants with Base Deficit </= -6 is reported. Base deficit is the absolute difference of the base deficit from its normal range (-2 to 2), and is used as an indicator for traumatic injuries. A base deficit </= - 6 signifies volume deficit and the need for volume resuscitation with fluids, blood or blood products either alone or in combination.|Upon arrival to the hospital|75 patients with complete HRV and trauma registry data||participants|||Number
781494|NCT00795600|Secondary|Number of Non-serious Adverse Events|Number of episodes reported during the trial.|Weeks 0-26|Full analysis set is all randomised subjects who were exposed at least one dose of the trial product.||events|||Number
781495|NCT00795600|Secondary|Number of Hypoglycaemic Episodes|Number of episodes reported during the trial.|Weeks 0-26|Full analysis set is all randomised subjects who were exposed at least one dose of the trial product.||episodes|||Number
781496|NCT00795600|Secondary|Absolute Change in PAI-1 (Plasminogen Activator Inhibitor-1)||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Three subjects from the Insulin Detemir group and one subject from the Insulin NPH group did not show a PAI-1 available value at week 0. Three subjects from each treatment group did not present a PAI-1 available value at week 26.||ng/L||Standard Error|Least Squares Mean
781497|NCT00795600|Secondary|Absolute Change in hsCRP (Highly Sensitive C Reactive Protein)|Absolute change in hsCRP was based on ANCOVA model for absolute change from week 0 to week 26 as response variable with treatment, sex and Metformin use as fixed factors, and hsCRP at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. One subject from each treatment group did not present a hsCRP available value at week 0. Two subjects from the Insulin Detemir group and three subjects from the Insulin NPH group did not show a hsCRP available value at week 26.||mg/L||Standard Error|Least Squares Mean
781498|NCT00795600|Secondary|Absolute Change in Hip Circumference|Absolute Change in Hip Circumferences was based on ANCOVA model for absolute change from week 0 to week 26 as response variable with treatment, sex, and Metformin use as fixed factors, and hip circumference at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. One subject in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in hip circumference at week 26.||cm||Standard Error|Least Squares Mean
781499|NCT00795600|Secondary|Absolute Change in Waist Circumference|Absolute change in waist circumference was based on ANCOVA model for absolute change from week 0 to week 26 as response variable with treatment, sex and Metformin use as fixed factors, and Waist at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. One subject in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in waist circumference at week 26.||cm||Standard Error|Least Squares Mean
781500|NCT00795600|Secondary|Absolute Change in Body Weight|Absolute change in body weight was based on ANCOVA model for absolute change from week 0 to week 26 as response variable with treatment, sex and Metformin use as fixed factors, and body weight at week 0 as covariable.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. One subject in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in body weight at week 26.||kg||Standard Error|Least Squares Mean
781501|NCT00795600|Secondary|Absolute Change in Potassium||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Three subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in Potassium at week 26.||mmol/L||Standard Deviation|Mean
781502|NCT00795600|Secondary|Absolute Change in Sodium||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in Sodium at week 26.||mmol/L||Standard Deviation|Mean
785301|NCT00836095|Secondary|Insertion Success Rate|Insertion success rate will be reported as the number of patients for whom the airway device was successfully inserted and ventilation was verified.|During intubation of the patient|||Number of successful airway insertions|||Number
781503|NCT00795600|Secondary|Absolute Change in Alkaline Phosphatase||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. One subject in the Insulin Detemir group did not present an albumin baseline value and another two at week 26 and four subjects in the Insulin NPH group did not present a value in the Alkaline Phosphatase at week 26.||IU/L||Standard Deviation|Mean
781504|NCT00795600|Secondary|Absolute Change in Aspartate Aminotransferase (ASAT)||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the ASAT at week 26.||IU/L||Standard Deviation|Mean
781505|NCT00795600|Secondary|Absolute Change in Alanine Aminotransferase (ALAT)||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the ALAT at week 26.||IU/L||Standard Deviation|Mean
781506|NCT00795600|Secondary|Absolute Change in Bilirubin Total||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the Bilirubin Total at week 26.||mg/dL||Standard Deviation|Mean
781507|NCT00795600|Secondary|Absolute Change in Albumin||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group did not present an albumin baseline value and another two at week 26 and four subjects in the Insulin NPH group did not present a value in the albumin at week 26.||mg/dL||Standard Deviation|Mean
781508|NCT00795600|Secondary|Absolute Change in Urea||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the Urea at week 26.||mg/dL||Standard Deviation|Mean
781509|NCT00795600|Secondary|Absolute Change in Creatine Phosphokinase||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the Creatine Phosphokinase at week 26.||IU/L||Standard Deviation|Mean
781510|NCT00795600|Secondary|Absolute Change in Creatinine||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the Creatinine at week 26.||mg/dL||Standard Deviation|Mean
781511|NCT00795600|Secondary|Absolute Change in Basophils||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. The comparison between visits could only be done with nine subjects in the Insulin Detemir group since only these patients had values available at week 0 and at week 26 while this applied to 22 subjects in the Insulin NPH group.||10^9 cells/L||Standard Deviation|Mean
781512|NCT00795600|Secondary|Absolute Change in Eosinophils||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. The comparison between visits could only be done with nine subjects in the Insulin Detemir group since only these patients had values available at week 0 and at week 26 while this applied to 22 subjects in the Insulin NPH group.||10^9 cells/L||Standard Deviation|Mean
781513|NCT00795600|Secondary|Absolute Change in Neutrophils||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. The comparison between visits could only be done with nine subjects in the Insulin Detemir group since only these patients had values available at week 0 and at week 26 while this applied to 22 subjects in the Insulin NPH group.||percentage||Standard Deviation|Mean
781514|NCT00795600|Secondary|Absolute Change in Monocytes||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Only one subject in the Insulin Detemir group presented values at week 26 in Monocytes, whilst no subjects showed available values at week 26 in the Insulin NPH group.||percentage||Standard Deviation|Mean
781515|NCT00795600|Secondary|Absolute Change in Lymphocytes||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Only one subject in the Insulin Detemir group presented values at week 26 in Lymphocytes, whilst no subjects showed available values at week 26 in the Insulin NPH group.||percentage||Standard Deviation|Mean
781516|NCT00795600|Secondary|Absolute Change in Leucocytes||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in Leucocytes at week 26.||10^9 cells/L||Standard Deviation|Mean
781517|NCT00795600|Secondary|Absolute Change in Erythrocytes||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in Erythrocytes at week 26.||percentage||Standard Deviation|Mean
781518|NCT00795600|Secondary|Absolute Change in Thrombocytes||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Only one subjects in the Insulin Detemir group presented values at week 26 in thrombocytes, whilst no subjects showed available values at week 26 in the Insulin NPH group.||percentage||Standard Deviation|Mean
781519|NCT00795600|Secondary|Absolute Change in Blood Volume (Haematocrit)||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the Haematocrit at week 26.||percentage||Standard Deviation|Mean
781520|NCT00795600|Secondary|Absolute Change in Haemoglobin||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the haemoglobin at week 26.||g/dL||Standard Deviation|Mean
781522|NCT00795600|Secondary|Absolute Change in Triglycerides||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Three patients in the Insulin Detemir group and six patients in the Insulin NPH group did not present a value in the triglycerides at week 26.||mg/dL||Standard Deviation|Mean
781523|NCT00795600|Secondary|Absolute Change in Very Low Density Lipoprotein (VLDL) Cholesterol||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Three patients in the Insulin Detemir group and seven patients in the Insulin NPH group did not present a value in the VLDL cholesterol at week 26.||mg/dL||Standard Deviation|Mean
781524|NCT00795600|Secondary|Absolute Change in Low Density Lipoprotein (LDL) Cholesterol||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Three subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the LDL cholesterol at week 26.||mg/dL||Standard Deviation|Mean
781525|NCT00795600|Secondary|Absolute Change in High Density Lipoprotein (HDL) Cholesterol||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Three subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the HDL cholesterol at week 26.||mg/dL||Standard Deviation|Mean
781526|NCT00795600|Secondary|Absolute Change in Total Cholesterol||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Three subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the total cholesterol at week 26.||mg/dL||Standard Deviation|Mean
781527|NCT00795600|Secondary|Absolute Change in Adiponectin|Absolute change in adiponectin as response variable with treatment, sex and Metformin use as fixed factors, and Adiponectic at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Six subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the adiponectin at week 26.||mcg/dL||Standard Error|Least Squares Mean
781528|NCT00795600|Secondary|Absolute Change in Fasting Plasma Glucose (FPG)|Absolute Change in Fasting Plasma Glucose as response variable with treatment, sex and Metformin use as fixed factors, and Fasting Plasma Glucose at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and six subjects in the Insulin NPH group did not present a value in the fasting plasma glucose at week 26.||mg/dL||Standard Error|Least Squares Mean
781529|NCT00795600|Secondary|Absolute Change in HbA1c (Glycosylated Haemoglobin)|Absolute Change in HbA1c as response variable with treatment, sex and Metformin use as fixed factors, and HbA1c at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the hbA1c at week 26.||percentage of glycosylated haemoglobin||Standard Error|Least Squares Mean
781530|NCT00795600|Secondary|Percentage Change in Liver/Spleen Attenuation Ratio|Percentage Change in Liver/Spleen Attenuation Ratio as response variable with treatment, sex and Metformin use as fixed factors, and Liver to Spleen Attenuation Ratio at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the liver to spleen attenuation ratio at week 26.||percent change||Standard Error|Least Squares Mean
781531|NCT00795600|Secondary|Absolute Change in Liver/Spleen Attenuation Ratio|Absolute change in Liver/Spleen Attenuation Ratio as response variable with treatment, sex and Metformin use as fixed factors, and Liver/Spleen Attenuation Ratio at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the liver to spleen attenuation ratio at week 26.||ratio||Standard Error|Least Squares Mean
781532|NCT00795600|Secondary|Percentage Change in Calculated Visceral/Subcutaneous Adipose Tissue Ratio|Percentage Change in Calculated Visceral/Subcutaneous Adipose Tissue Area as response variable with treatment, sex and Metformin use as fixed factors, and Calculated Visceral/Subcutaneous Adipose Tissue Area at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the calculated Visceral /Subcutaneous adipose tissue ratio at week 26.||percent change||Standard Error|Least Squares Mean
781533|NCT00795600|Secondary|Absolute Change in Calculated Visceral/Subcutaneous Adipose Tissue Ratio|Absolute change in Calculated Visceral/Subcutaneous Adipose Tissue Ratio as response variable with treatment, sex and Metformin use as fixed factors, and Calculated Visceral/Subcutaneous Adipose Tissue Area at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the calculated Visceral /Subcutaneous adipose tissue ratio at week 26.||ratio||Standard Error|Least Squares Mean
781534|NCT00795600|Secondary|Percentage Change in Subcutaneous Adipose Tissue Area|Percentage Change in Subcutaneous Adipose Tissue Area as response variable with treatment, sex and Metformin use as fixed factors, and Subcutaneous Adipose Tissue Area at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the subcutaneous adipose tissue area at week 26.||percent change||Standard Error|Least Squares Mean
781535|NCT00795600|Secondary|Absolute Change in Subcutaneous Adipose Tissue Area|Absolute change in subcutaneous adipose tissue area as response variable with treatment, sex and Metformin use as fixed factors, and subcutaneous adipose tissue area at week 0 as covariate|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the subcutaneous adipose tissue area at week 26.||cm^2||Standard Error|Least Squares Mean
781536|NCT00795600|Secondary|Percentage Change in Visceral Adipose Tissue Area|Percentage Change in Visceral Adipose Tissue Area as response variable with treatment, sex and Metformin use as fixed factors, and Visceral Adipose Tissue Area at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the visceral adipose tissue area at week 26.||percent change||Standard Error|Least Squares Mean
781537|NCT00795600|Secondary|Absolute Change in Visceral Adipose Tissue Area|Absolute change in visceral adipose tissue area as response variable with treatment, sex and Metformin use as fixed factors, and visceral adipose tissue area at week 0 as covariate|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the visceral adipose tissue area at week 26.||cm^2||Standard Error|Least Squares Mean
781538|NCT00795600|Secondary|Percentual Change in Calculated Trunk Fat Percentage|Percentual Change in Calculated Trunk Fat Percentage as response variable with treatment, sex and Metformin use as fixed factors, and Calculated Trunk Fat Percentage at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the calculated trunk fat percentage at week 26.||percent change||Standard Error|Least Squares Mean
781539|NCT00795600|Secondary|Absolute Change in Calculated Trunk Fat Percentage|Absolute change in calculated trunk fat percentage as response variable with treatment, sex and Metformin use as fixed factors, and calculated trunk fat percentage at week 0 as covariate|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the calculated trunk fat percentage at week 26.||percent of trunk fat (%)||Standard Error|Least Squares Mean
781540|NCT00795600|Secondary|Percentual Change in Calculated Whole Body Fat Percentage|Percentual Change in Calculated Whole Body Fat Percentage as response variable with treatment, sex and Metformin use as fixed factors, and Calculated Whole Body Fat Percentage at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the calculated whole body fat percentage at week 26.||percent change||Standard Error|Least Squares Mean
781541|NCT00795600|Secondary|Absolute Change in Calculated Whole Body Fat Percentage|Absolute change in calculated whole body fat percentage as response variable with treatment, sex and Metformin use as fixed factors, and calculated whole body fat percentage at week 0 as covariate|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the calculated whole body fat percentage at week 26.||percent of whole body fat (%)||Standard Error|Least Squares Mean
781542|NCT00795600|Secondary|Percentage Change in Trunk Lean Mass|Percentage Change in Trunk Lean Mass as response variable with treatment, sex and Metformin use as fixed factors, and Trunk Lean Mass at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the change in trunk lean mass at week 26.||percent change||Standard Error|Least Squares Mean
781543|NCT00795600|Secondary|Absolute Change in Trunk Lean Mass|Absolute change in trunk lean mass as response variable with treatment, sex and Metformin use as fixed factors, and trunk lean mass at week 0 as covariate|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the change in trunk lean mass at week 26.||grams (g)||Standard Error|Least Squares Mean
781544|NCT00795600|Secondary|Percentage Change in Whole Body Lean Mass|Percentage Change in Whole Body Lean Mass as response variable with treatment, sex and Metformin use as fixed factors, and whole Body Lean Mass at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the change in whole body lean mass at week 26.||percent change||Standard Error|Least Squares Mean
781545|NCT00795600|Secondary|Absolute Change in Whole Body Lean Mass|Absolute change in whole body lean mass as response variable with treatment, sex and Metformin use as fixed factors, whole body lean mass at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the change in whole body lean mass at week 26.||grams (g)||Standard Error|Least Squares Mean
781546|NCT00795600|Secondary|Percentage Change in Whole Body Fat Mass|Percentage Change in Whole Body Fat Mass as response variable with treatment, sex and Metformin use as fixed factors, and whole Body Fat Mass at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the change in whole body fat mass at week 26.||percent change||Standard Error|Least Squares Mean
781547|NCT00795600|Secondary|Absolute Change in Whole Body Fat Mass|Absolute change in whole body fat mass as response variable with treatment, sex and Metformin use as fixed factors, and trunk fat mass at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the change in whole body fat mass at week 26.||grams (g)||Standard Error|Least Squares Mean
781562|NCT00795886|Primary|Two Year Overall Survival|The probability that a given patient will be alive two years after transplantation. The Kaplan-Meier product limit method was used to compute the probability of overall survival to 2 years. Greenwood's formula was used to compute the standard error.|24 months after transplant|All patients enrolled in study.||probability||Standard Error|Mean
781548|NCT00795600|Primary|Absolute Change in Trunk Fat Mass|Absolute change in trunk fat mass as response variable with treatment, sex and Metformin use as fixed factors, and trunk fat mass at week 0 as covariate.|week 0, week 26|Per protocol (PP) population: All randomised and exposed subjects who completed the 26-week treatment without significantly deviating from the inclusion/exclusion criteria and the withdrawal criteria or other aspects of the protocol considered to potentially affect the efficacy results. Compared to the ITT population, two subjects were excluded.||grams (g)||Standard Error|Least Squares Mean
781549|NCT00795600|Primary|Absolute Change in Trunk Fat Mass|Absolute change in trunk fat mass as response variable with treatment, sex and Metformin use as fixed factors, and trunk fat mass at week 0 as covariate.|week 0, week 26|ITT analysis set using LOCF is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the change in trunk fat mass at week 26.||grams (g)||Standard Error|Least Squares Mean
781550|NCT00795600|Primary|Percentage Change in Trunk Fat Mass (Defined as Peripheral Fat Ratio)|Percentage of change of trunk fat mass as the dependent variable, baseline value (trunk fat mass at week 0) as covariate, treatment with metformin (yes/no) and gender (male/female) as effect and the treatment received (insulin detemir/insulin NPH) as the main factor.|week 0, week 26|Per protocol (PP) population: All randomised and exposed subjects who completed the 26-week treatment without significantly deviating from the inclusion/exclusion criteria and the withdrawal criteria or other aspects of the protocol considered to potentially affect the efficacy results. Compared to the ITT population, two subjects were excluded.||percent change||Standard Error|Least Squares Mean
781551|NCT00795600|Primary|Percentage Change in Trunk Fat Mass (Defined as Peripheral Fat Ratio)|Percentage of change of trunk fat mass as the dependent variable, baseline value (trunk fat mass at week 0) as covariate, treatment with metformin (yes/no) and gender (male/female) as effect and the treatment received (insulin detemir/insulin NPH) as the main factor.|week 0, week 26|Intention-To-Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the change in trunk fat mass at week 26.||percent change||Standard Error|Least Squares Mean
781552|NCT00795639|Secondary|Time to Clinical Worsening (TTCW)|TTCW defined as the number of days between first dose of study drug and the occurrence of a predefined clinical worsening event. Predefined clinical worsening events included: hospitalization for worsening PAH, on-study death, heart-lung or lung transplant, atrial septostomy or withdrawal due to the addition of any chronic medications for the treatment of worsening PAH.|Baseline, Weeks 4, 8 and 12 or ET|ITT; N=number of participants with analyzable data||days||Full Range|Median
781553|NCT00795639|Secondary|Number of Participants With Change From Baseline in World Health Organization (WHO) Functional Classification at Weeks 4, 8 and 12|WHO functional classification for PAH ranges from Class I (no limitation in physical activity, no dyspnea with normal activity) to Class IV (cannot perform a physical activity without any symptoms, dyspnea at rest). Improvement = reduction in functional class, deterioration = increase in functional class, no change = no change in functional class.|Baseline, Weeks 4, 8 and 12 or Early Termination (ET)|ITT; N=number of participants with analyzable data; n=number of participants with analyzable data at the specific time point||participants|||Number
781554|NCT00795639|Primary|Change From Baseline in Total Distance Walked During 6 Minute Walk Distance (6MWD) at Week 12|6 MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. Continuous pulse oximetry was conducted during the test for safety. Change is Week 12 results minus baseline results.|Baseline/Day 1 and Week 12|Intent to treat population (ITT): all participants who were randomized; missing value at Week 12 imputed with last non-missing value, including the non-missing value obtained at early termination based on last observation carried forward (LOCF)||Meters (m)||Full Range|Median
781555|NCT00795704|Secondary|Change From Baseline in Self-Monitoring Blood Glucose (SMBG) Averages|2-hour postprandial SMBG reported. A negative value indicates a decrease from baseline. A positive value indicates an increase from baseline.|Baseline and 3 months|Intention-to-treat with data submitted baseline and final.||mg/dL||Standard Deviation|Mean
781556|NCT00795704|Secondary|Number of Participants With Adverse Drug Reactions, Abnormal Metabolic Panel Levels, or Abnormal Liver Enzyme Levels|Sodium (>150 mmol/L), Potassium (>5 mmol/L), Bicarbonate (>34 mmol/L), Chloride (>110 mmol/L), Serum Creatinine (>1.2 mg/dL), Blood Urea Nitrogen (24 mg/dL), Calcium (>11 mg/L), Alanine Aminotransferase (>3 times baseline), Aspartate Aminotransferase (>3 times baseline) were collected at baseline, 1 month, and 3 months. Self-Reported adverse drug reactions are also reported.|Baseline, 1 month, and 3 months|||participants|||Number
781557|NCT00795704|Primary|Hemoglobin A1C||3 month minus baseline|intention-to-treat||percent||Standard Deviation|Mean
781558|NCT00795717|Secondary|Brachial Artery Reactivity|"To demonstrate the impact of omega-three fatty acid intake on BART (Brachial Artery Reactivity Test) at 12 weeks.
Brachial artery ultrasound measurements Brachial artery reactivity will be assessed by ultrasound and FMD will be calculated as the change in brachial artery diameter after release of suprasystolic blood pressure cuff inflation. A blood pressure cuff will be inflated on the upper arm to induce increase in blood flow, termed reactive hyperemia, which increases arterial diameter. The change in vessel diameter is determined by high-resolution ultrasound imaging. The endothelium-dependent FMD of the brachial artery is quantified as the maximum percent change in arterial diameter, expressed in units of % of brachial artery."|12 weeks|||% of brachial artery diameter||Standard Deviation|Mean
781559|NCT00795717|Secondary|Serum HDL Level||12 weeks|||mg/dl||Standard Deviation|Mean
781560|NCT00795717|Primary|Change in Baseline Mean Serum Triglyceride Level at Study End|Change in Baseline (time 0) Mean Serum Triglyceride levels after 12 weeks of treatment or placebo|Baseline and 12 weeks|Randomized, cross over design||mg/dl||Standard Deviation|Mean
781561|NCT00795769|Primary|Reduction in Rates of Nausea or Vomiting After Ondansetron (Compared to FHCRC Historical Rates)|Nausea Multinational Association of Supportive Care in Cancer Antiemesis Tool™ (MAT). Increased MAT scores represent worse outcome (score 0-10). Vomiting represented as present or absent.|Baseline up to 120 minutes|||Participants|||Count of Participants
781563|NCT00795886|Secondary|Percentage of Patients Developing Acute Graft vs. Host Disease (GVHD)|Cumulative incidence of Grade 2-4 acute GVHD at 180 days.|180 days|||percentage of participants||95% Confidence Interval|Number
781564|NCT00795886|Primary|Number of Participants With Transplant-related Mortality|Death not associated with relapse. We determined that if transplant related mortality(TRM) 25% at day 100 or if Grade III-IV (severe, life threatening, or disabling) acute GVHD was >30% a stopping rule would be triggered.|24 months after transplant|All participants enrolled in the trial.||participants|||Number
781565|NCT00795951|Secondary|Itching/Burning|Number of subjects who presented with itching/burning at patch removal|Day 2: 48 hours after patch application|||participants|||Number
781566|NCT00795951|Secondary|Adhesion|Number of subjects who presented with poor adhesion at patch removal|Day 2: 48 hours after application|||participants|||Number
781567|NCT00795951|Secondary|Irritation|Number of subjects who presented with irritation at patch removal|Visit 2: 48 hours after patch application|||participants|||Number
781568|NCT00795951|Secondary|Persistent Reactions|Number of subjects who presented with persistent reactions|appear 2-4 days after patch application and last through 7-14 days after application|||participants|||Number
781569|NCT00795951|Secondary|Late Reactions|Number of subjects who presented with late reactions|7-10 days after patch application|||participants|||Number
781570|NCT00795951|Primary|Diagnostic Performance: Quinoline Mix|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application|||participants|||Number
781571|NCT00795951|Primary|Diagnostic Performance: Tixocortol-21-pivalate|Number of subjects with positive reactions at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application|||participants|||Number
781572|NCT00795951|Primary|Diagnostic Performance: Budesonide|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application|||participants|||Number
781573|NCT00795951|Primary|Diagnostic Performance: Imidazolidinyl Urea|Number of subjects with positive reactions at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application|||participants|||Number
781574|NCT00795951|Primary|Diagnostic Performance: Diazolidinyl Urea|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application|||participants|||Number
781575|NCT00795951|Primary|Diagnostic Performance: Thiuram Mix|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application|||participants|||Number
781576|NCT00795951|Primary|Diagnostic Performance: Thimerosal|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application|||participants|||Number
781577|NCT00795951|Primary|Diagnostic Performance: Mercapto Mix|Number of subjects with positive reactions at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application|||participants|||Number
781578|NCT00795951|Primary|Diagnostic Performance: Formaldehyde|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application|||participants|||Number
781579|NCT00795951|Primary|Diagnostic Performance: p-Phenylenediamine|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application|||participants|||Number
781580|NCT00795951|Primary|Diagnostic Performance: Mercaptobenzothiazole|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application|||participants|||Number
781581|NCT00795951|Primary|Diagnostic Performance: Quaternium-15|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application|||participants|||Number
781582|NCT00795951|Primary|Diagnostic Performance: Cl+Me-Isothiazolinone|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application|||participants|||Number
781583|NCT00795951|Primary|Diagnostic Performance: Black Rubber Mix|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application|||participants|||Number
781584|NCT00795951|Primary|Diagnostic Performance: Carba Mix|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application|||participants|||Number
781585|NCT00795951|Primary|Diagnostic Performance: Epoxy Resin|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application|||participants|||Number
781586|NCT00795951|Primary|Diagnostic Performance: P-tert Butylphenol Formadehyde Resin|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application|||participants|||Number
781587|NCT00795951|Primary|Diagnostic Performance: Cobalt Dichloride|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application|||participants|||Number
781588|NCT00795951|Primary|Diagnostic Performance: Ethylenediamine Dihydrochloride|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application|||participants|||Number
781589|NCT00795951|Primary|Diagnostic Performance: Balsam of Peru|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application|||participants|||Number
781590|NCT00795951|Primary|Diagnostic Performance: Negative Control|Number of subjects with positive reactions recorded at visit 3 or visit 4.|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application|||participants|||Number
781591|NCT00795951|Primary|Diagnostic Performance: Paraben Mix|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application|||participants|||Number
781592|NCT00795951|Primary|Diagnostic Performance: Colophony|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application|||participants|||Number
781593|NCT00795951|Primary|Diagnostic Performance: Fragrance Mix|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application|||participants|||Number
781597|NCT00795951|Primary|Diagnostic Performance: Neomycin Sulfate|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application|The prevalence of allergic contact dermatitis varies greatly (≤1%-10%) in consecutive subjects. Therefore, estimates of sample size and study power are based on overall AE rates, which are generally similar across populations and test allergens and for which there is relevant historical data.||participants|||Number
781598|NCT00795951|Primary|Diagnostic Performance: Nickel Sulfate|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application|All completed subjects were included in the efficacy analysis.||participants|||Number
781599|NCT00796003|Secondary|Phase II: Number of Participants With Cytogenic Response - as Per International Working Group (IWG) Response Criteria 2000 (Major/Minor) and IWG 2006 (Complete/Partial)|IWG 2000 - Major: disappearance of cytogenetic abnormality; Minor: 50% or more reduction in abnormal metaphases. IWG 2006 - Complete: disappearance of the chromosomal abnormality without appearance of new ones; Partial: At least 50% reduction of the chromosomal abnormality.|Up to 1.5 years after the last participant enrolled|20 participants who had chromosomal abnormality were evaluated in Phase II for cytogenetic response. The IWG criteria requires 20 analyzable metaphases using conventional cytogenetic techniques.||Participants|||Number
781600|NCT00796003|Secondary|Phase II: Overall Improvement Rate: Number of Participants Who Achieved Complete Response (CR)+Partial Response (PR)+Hematological Improvement (HI) - as Per International Working Group (IWG) Response Criteria (2000)|IWG response criteria (2000) - CR: bone marrow evaluations (mCR) show < 5% blasts; no dysplasia; normal maturation of all cell lines and peripheral blood shows hemoglobin ≥ 11 g/dL; neutrophils ≥ 1,500/mL; platelets ≥ 100,000/mL; 0% blasts; no dysplasia and PR: same as CR, except blasts decrease by ≥ 50% or lower French-American-British (FAB) classification of Myelodysplastic Syndromes. HI: hemoglobin < 11 g/dL (erythroid); platelet < 100,000/mL; neutrophils < 1,000/mL.|Up to 1.5 years after the last participant enrolled|Full Analysis Set (FAS): 34 participants were included in this set||Participants|||Number
781601|NCT00796003|Secondary|Phase II: Median Duration of Overall Improvement|Median time duration for which participants achieved overall improvement (complete remission+partial remission+hematologic improvement).|Up to 1.5 years after the last participant enrolled|14 participants who achieved overall improvement were evaluated.||Days||Full Range|Median
781602|NCT00796003|Secondary|Phase II: Median Duration of Remission|Median time duration for which participants achieved remission (complete remission+partial remission).|Up to 1.5 years after the last participant enrolled|9 participants who achieved remission were evaluated.||Days||Full Range|Median
781603|NCT00796003|Secondary|Phase II: Median Time to Improvement|Median time required for the participants to achieve overall improvement (complete remission+partial remission+hematologic improvement)|Up to 1.5 years after the last participant enrolled|14 participants who achieved overall improvement were evaluated.||Days||95% Confidence Interval|Median
781604|NCT00796003|Secondary|Phase II: Median Time to Remission|Median time required for the participants to achieve remission (complete remission+partial remission).|Up to 1.5 years after the last participant enrolled|9 participants who achieved remission were evaluated.||Days||95% Confidence Interval|Median
781605|NCT00796003|Secondary|Phase I: Number of Participants Who Achieved Complete Remission (CR)+Partial Remission (PR)+Hematological Improvement (HI) - as Per International Working Group (IWG) Response Criteria (2000)|IWG response criteria (2000) - CR: bone marrow evaluations (mCR) show < 5% blasts; no dysplasia; normal maturation of all cell lines and peripheral blood shows hemoglobin ≥ 11 g/dL; neutrophils ≥ 1,500/mL; platelets ≥ 100,000/mL; 0% blasts; no dysplasia; PR: same as CR, except blasts decrease by ≥ 50% or lower French-American-British (FAB) classification of Myelodysplastic Syndromes; HI: hemoglobin < 11 g/dL (erythroid); platelet < 100,000/mL; neutrophils < 1,000/mL.|Up to 28 Days of treatment Cycle 1|Full Analysis Set (FAS): 9 participants were included in this set for Phase I||Participants|||Number
781606|NCT00796003|Secondary|Phase I: Area Under the Plasma Concentration-time Curve (AUC)|Area under the curve from time zero to extrapolated infinite time (AUC Infinity) and area under the curve from time zero to last quantifiable concentration (AUC Last).|Before dosing (Pre-dose), 30 min, 60 min (end of infusion), 65 min, 75 min, 90 min, 120 min, 180 min, 240 min after the start of decitabine infusion on Day 1 and Day 5 of 28-Days Cycle 1|Pharmacokinetic Population: 8 participants were evaluated for pharmacokinetic analysis||ng*h/mL||Standard Deviation|Mean
781607|NCT00796003|Secondary|Phase I: Maximum Observed Plasma Concentration of Decitabine (Cmax)||Before dosing (Pre-dose), 30 min, 60 min (end of infusion), 65 min, 75 min, 90 min, 120 min, 180 min, 240 min after the start of decitabine infusion on Day 1 and Day 5 of 28-Days Cycle 1|Pharmacokinetic Population: 8 participants were evaluated for pharmacokinetic analysis||ng/mL||Standard Deviation|Mean
781608|NCT00796003|Primary|Phase I and II: Number of Participants Who Experienced Adverse Events||Up to 1.5 years after the last participant enrolled|Safety Population: 9 participants in Phase I and 34 participants in Phase II were evaluated for safety||Participants|||Number
781609|NCT00796003|Primary|Phase II: Overall Remission Rate (ORR): Number of Participants Who Achieved Complete Remission (CR)+Partial Remission (PR) - as Per International Working Group (IWG) Response Criteria (2000)|IWG response criteria (2000) - CR: bone marrow evaluations show < 5% blasts; no dysplasia; normal maturation of all cell lines and peripheral blood shows hemoglobin ≥ 11 g/dL; neutrophils ≥ 1,500/mL; platelets ≥ 100,000/mL; 0% blasts; no dysplasia and PR: same as CR, except blasts decrease by ≥ 50% or lower French-American-British (FAB) classification of Myelodysplastic Syndromes.|Up to 1 years after the last participant enrolled|Full Analysis Set (FAS): 34 participants were included in this analysis set for Phase II||Participants|||Number
781610|NCT00796120|Secondary|Duration of Response (DOR)|The DOR is defined as the time from date of first documentation of response (CR or PR, whichever comes first) to the date of documented PD or death. PR=at least 30% reduction in the sum of the longest dimensions (LD) of all target lesions in reference to the baseline sum LD, CR =Disappearance of all non-target lesions.|Up to 20 months|Efficacy population included all participants randomly assigned to either treatment arm with externally confirmed pathological and molecular diagnosis of TRS. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.||days||95% Confidence Interval|Median
785350|NCT00825500|Primary|Pain-Relief at 2 Hours Post-treatment|Pain-Relief=pretreatment pain rating of 2 (moderate) or 3 (severe) and a rating of 0 (none) or 1 (mild) at the designated assessment time|2 hours|ITT with LOCF Population||Participants|||Count of Participants
781611|NCT00796120|Secondary|Overall Survival|Overall survival defined as time from the date of randomization to the date of death. For participants who were alive at the time of analysis, overall survival was censored at the last contact date.|Baseline up to End of Study (an average of 4 years)|Efficacy population included all participants randomly assigned to either treatment arm with externally confirmed pathological and molecular diagnosis of TRS.||months||95% Confidence Interval|Median
781612|NCT00796120|Secondary|Percentage of Participants With Objective Response|Tumor response was assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Partial Response (PR)=at least 30% reduction in the sum of the longest dimensions (LD) of all target lesions in reference to the baseline sum LD, Complete Response (CR) =Disappearance of all non-target lesions. Percentage of participants with objective tumor response was determined by the number of participants with PR or CR divided by the total number of response-evaluable participants.|Every 6 weeks during first 9 months of the study and thereafter every 9 weeks up to 20 months|Efficacy population included all participants randomly assigned to either treatment arm with externally confirmed pathological and molecular diagnosis of TRS.||percentage of participants||95% Confidence Interval|Number
781613|NCT00796120|Secondary|6-month Progression - Free Survival|Percentage of participants survived for 6 months from the start of study treatment without progression of disease. Progression of the disease was associated with increasing symptoms, including pain from new or progressing lesions. Delay in disease progression generally represents a clinical benefit to the participant.|6 months|Efficacy population included all participants randomly assigned to either treatment arm with externally confirmed pathological and molecular diagnosis of TRS.||percentage of participants||95% Confidence Interval|Number
781614|NCT00796120|Primary|Progression - Free Survival (PFS)|The PFS was assessed as median number of days from the date of randomization until the first documented sign of disease progression (increase in disease; radiographic, clinical, or both) or death due to any cause, whichever occurred earlier.|Every 6 weeks from randomization during the first 9 months and thereafter, every 9 weeks up to 20 months|Efficacy population included all participants randomly assigned to either treatment arm with externally confirmed pathological and molecular diagnosis of translocation-related sarcomas (TRS)||months||95% Confidence Interval|Median
781615|NCT00796224|Secondary|Adverse Events (AEs) and Serious AEs (SAEs)|All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product(s) was reported.|Baseline up to 28 days|All subjects who received at least 1 dose of study medication were included in the safety analyses.||participants|||Number
781616|NCT00796224|Secondary|Number of Participants With a Clinical Response|"Clinical response was assesed between Days 7 and 10, or when subjects discontinued the study prematurely (if applicable). Response was assessed by the investigator as cure or failure. Cure = Clinical signs and symptoms related to the acute illness have resolved, or clinical improvement is such that no additional therapy is necessary. Failure = One or more of the following:
Signs and symptoms related to the acute illness have persisted or worsened and additional therapy is necessary;
New clinical signs and symptoms of acute illness have developed and additional therapy is necessary"|Days 7,8,9 or 10|Any worsening of existing signs and symptoms, or new signs and symptoms, were documented as adverse events.||participants|||Number
781617|NCT00796224|Secondary|Serum Concentrations of Azithromycin ER (Test) and Azithromycin IR (Reference)||1,2,3,4,8,24,48,72 hours postdose|All subjects randomized and treated who had at least 1 of the pharmacokinetic parameters of primary interest.||ng/ml|||Number
781618|NCT00796224|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) and Plasma Decay Half Life (t1/2) of Azithromycin|Plasma decay half-life is the time measured for the plasma concentration to decrease by one-half.|Predose/0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose|All subjects randomized and treated who had at least 1 of the pharmacokinetic parameters of primary interest.||hr||Full Range|Median
781619|NCT00796224|Secondary|Maximum Observed Plasma Concentration (Cmax) of Azithromycin||Predose/0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose|All subjects randomized and treated who had at least 1 of the pharmacokinetic parameters of primary interest.||ng/ml||Standard Deviation|Mean
781620|NCT00796224|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC Inf)|AUCinf = AUClast + (Clast* divided by kel), where AUClast is calculated by Linear-Log trapezoidal method, Clast* is the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.|Predose/0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose|All subjects randomized and treated who had at least 1 of the pharmacokinetic parameters of primary interest.||ng*hr/ml||Standard Deviation|Mean
781621|NCT00796224|Primary|Area Under the Curve From Time Zero to 72 Hours (AUC72Hours)|AUC72 = Area under the plasma concentration versus time curve from time zero (pre-dose) to 72 hours.|Predose/0 to 72 Hours|All subjects randomized and treated who had at least 1 of the pharmacokinetic parameters of primary interest.||ng*hr/ml||Standard Deviation|Mean
781622|NCT00796302|Other Pre-specified|Clinical Global Impressions Scale for Severity of Illness|Using this clinician rating scale the severity of the illness is scored from 1= normal to 7= extremely ill. This scale was used at baseline and Weeks 1, 2, 3, 4, 5, 6, 7, 8, & 9. Only endpoint (week 9 or subject's last visit) Clinical Global Impressions Scale for Severity of Illness scores are reported below.|Measured at endpoint visit|ADHD and severe physical aggression; participants who completed a study endpoint visit and were given a Clinical Global Impressions Scale for Severity of Illness rating||participants|||Number
781623|NCT00796302|Other Pre-specified|Clinical Global Impressions Scale for Improvement|Using this clinician rating scale the patient's improvement is scored on a 7-point scale which ranges from “very much improved” (1), through “no change” (4), to “very much worse” (7). This scale was used at baseline and Weeks 1, 2, 3, 4, 5, 6, 7, 8, & 9. Only endpoint (week 9 or subject's last visit) Clinical Global Impressions Scale for Improvement scores are reported below.|Measured at endpoint visit|ADHD & severe physical aggression; participants who completed a study endpoint visit and were given a Clinical Global Impressions Scale for Improvement rating||participants|||Number
781654|NCT00796614|Secondary|Change From Baseline in Urine Volume at Week 14|Change in baseline urine volumes obtained by catheterisation as recorded in catheterisation diary at Week 14.|Baseline and Week 14|Full analysis set-catheter (FAS-CATH): This analysis set includes all patients in the treated set who received at least one dose of randomised treatment, were on a catheterisation regimen, and had at least one on-treatment catheterisation assessment.||mL||Standard Error|Least Squares Mean
781624|NCT00796302|Other Pre-specified|Antisocial Behavior Scale - Reactive Aggression Subscale|The Antisocial Behavior Scale (ABS) is a 28-item scale that contains 10 Proactive Aggression items and six Reactive Aggression items. Each item is rated on a 3-point scale, ranging from 1 (Never) to 3 (Very often). Thus, scores on the Reactive Aggression subscale can range from 6 through 18; with higher scores indicating more reactive aggression.|Measured at baseline and Week 9|ADHD & severe physical aggression||units on a scale||Standard Deviation|Mean
781625|NCT00796302|Primary|NCBRF-TIQ D-Total Score|"Parent ratings of aggression and hostility on the Nisonger Child Behavior Rating Form-Typical IQ (NCBRF-TIQ) D-Total Score. The NCBRF provides 1 prosocial subscale (Positive/Social) and 6 problem behavior subscales (Conduct Problem, Oppositional Behavior, Hyperactive, Inattentive, Overly Sensitive, and Withdrawn/Dysphoric). The NCBRF has excellent internal consistency, distinguishes between controls and subjects with DBDs. Conduct Problem and Oppositional Behavior subscales map closely to DSM-IV-TR symptoms of CD and ODD; they were scored together to form a variable called the D-Total.
For the NCBRF D-Total, higher scores reflect worse behavior. Each subscale is scored by taking the rating (0 [did not occur or was not a problem] to 3 [occurred a lot or was a very severe problem]) for all component items. The D-Total score was computed by adding the 6 scores from the Oppositional subscale and the 10 items from the Conduct Problem subscale. Thus D-Total scores could range from 0-69."|Measured at baseline and Weeks 3, 4, 5, 6, 7, 8, 9|ADHD & severe physical aggression||units on a scale||Standard Deviation|Mean
781626|NCT00796315|Primary|Cmax of Doxylamine|Maximum concentration of Doxylamine from 0 to 72 hours post-dose|72 Hours|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
781627|NCT00796315|Primary|AUC of Doxylamine|Area under the time-concentration curve for Doxylamine from 0 to 72 hours post-dose plus an extrapolated area from 72 hours to infinity.|72 Hours|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
781628|NCT00796328|Primary|Effective Dose of Phenylephrine at Which 90% of Subjects Have no Spinal Induced Hypotension|The effective dose at which 90% of subjects will have a “positive” response to a phenylephrine infusion, i.e. no spinal induced hypotension. We hypothesize that the ED90 will be between 40 – 60 mcg/min.|Spinal administration until delivery|||dose of phenylephrine|||Number
781629|NCT00796367|Primary|Percentage of Subjects With at Least 5% Weight Loss at End of Treatment, Week 108.||Baseline to End of Treatment|Intent-to-treat Last-observation-carried-forward (ITT-LOCF)||percent participants|||Number
781630|NCT00796367|Primary|Percent Weight Change at End of Treatment, Week 108.||From baseline to end of treatment|Intent-to-Treat Last observation carried forward (ITT-LOCF)||percent weight loss||Standard Error|Least Squares Mean
781631|NCT00796419|Secondary|Ventilator-free Days|The ‘ventilator free survival days’ in a 30-day period is a previously validated method of comparing groups with respect to mechanical ventilator requirements while adjusting for mortality. This variable represents the number of days in the 30-day period following baseline that the patient is alive and not requiring mechanical ventilation.|Day 30|||days||Inter-Quartile Range|Median
781632|NCT00796419|Secondary|Change in Oxygenation (PaO2/FiO2 Ratio)|Change in arterial oxygenation measured by arterial blood gas analysis. The partial pressure of O2 in arterial blood to fraction of inspired oxygen ratio (PaO2/FiO2) is a ratio of partial pressure arterial oxygen to fractional inspired inspired oxygen. This ratio is used as an indicator of hypoxemia (low blood oxygen). A PaO2/FiO2 ratio of 200-300 indicates mild ARDS, 100-200 indicates moderate ARDS, and less than 100 indicates severe ARDS.|Baseline, Day 1|||mmHg||Standard Deviation|Mean
781633|NCT00796419|Primary|Change in Extravascular Lung Water (EVLW)|Quantity of extravascular lung water (EVLW) measured by transpulmonary thermodilution. Higher measurements of EVLW per kilogram of body weight indicate increased lung injury. Normal values for EVLW are thought to be less than 10 mL/kg.|Baseline to Day 5 (120 hours)|||mL/kg||Standard Deviation|Mean
781634|NCT00796510|Secondary|Number of Participants in Each World Health Organization (WHO) Functional Class of Pulmonary Arterial Hypertension (PAH)|The WHO functional classes of PAH range from Class 1 (no limitation in physical activity) to Class IV (can not perform a physical activity without any symptoms).|Baseline, Week 12 and ET (up to Week 18)|Due to the premature termination only 3 participants were recruited into this study. No analyses were performed.||participants|||Number
781635|NCT00796510|Secondary|Change From Baseline in 6 Minute Walk Distance at Weeks 12 and 24|The walk distance was the total distance walked during the 6-minute test. Change is distance walked at week x minus distance walked at baseline.|Baseline, Weeks 12 up to Early Termination (ET) (up to Week 18)|Due to the premature termination only 3 participants were recruited into this study. No analyses were performed.||meters||Standard Deviation|Mean
781636|NCT00796510|Primary|Overall Survival|Overall survival is the duration from first dose to death. For participants who are lost to follow-up, survival was censored at the last date of follow-up.|Baseline and every 12 weeks up to Week 18|Due to the premature termination only 3 participants were recruited into this study. No analyses were performed.||weeks||Standard Deviation|Mean
781637|NCT00796523|Primary|Hours Per Day of Sleep|mean sleep time is the mean of 3 daily sleep times reported in a time period.|week 8|Results based on ITT; 16 subjects did not complete any diaries and are not included in the analysis||hours per day||Standard Deviation|Mean
781638|NCT00796523|Primary|Hours Per Day of Fuss/Cry|total hours per day of fuss, cry, and unsoothable crying.|week 8|If fewer than 3 diaries were completed for a given time period (that is, one or two of the days was missing or had more than 180 minutes unrecorded), then the average of only the completed diaries was used. Results are based on ITT; 16 subjects did not complete any diaries and are not included in the analysis||hours per day||Standard Deviation|Mean
781639|NCT00796523|Secondary|Parenting Stress Index|a continuous scale measuring stress with a range of 131 (low) to 320 (high); the average person's stress scores are between 188 and 252.|week 6|results based on ITT; 16 subjects did not complete any diaries or data collection instruments and are not included in the analysis||points on a scale||Standard Deviation|Mean
781655|NCT00796614|Secondary|Response With Regard to Hydroureter Was Defined as Improvement or Stabilisation Based Upon the Renal Ultrasound at Week 14 (End of Treatment) Compared to Baseline|"Hydroureter response was defined as stabilisation or improvement based on change from baseline in the presence or absence of hydroureter at the end of treatment (Week 14).
Response defined as stabilization or improvement of hydroureter measured by renal ultrasound compared to baseline by treatment group (Patients are classified according to the treatment they were taking at Week 14 or end of treatment) at Week 14."|Baseline and Week 14|Full analysis set-renal (FAS-RENAL)||Participants|||Number
781640|NCT00796549|Secondary|Assessment of Eastern Cooperative Oncology Group (ECOG) Performance Status|"Performance status assessed according to Eastern Cooperative Oncology Group (ECOG) performance status based on categories defined below :
0 : Fully active, able to carry on all pre-disease performance without restriction.
: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.
: Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours.
: Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours.
: Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair.
: Dead.
Note: The ECOG scores presented are assessed at the end of treatment not at baseline, hence the patients having ECOGs>2 are included."|End Of Treatment, up until 190 weeks|Treated set (TS).||percentage of participants|||Number
781641|NCT00796549|Secondary|Number of Participants With Clinical Relevant Findings in Laboratory Safety Parameters, Vital Signs and Left Ventricular Ejection Fraction|"Number of participants with clinical relevant findings in Laboratory safety parameters, vital signs and Left ventricular ejection fraction . Relevant findings or worsenings of baseline conditions were reported as Adverse Events.
There were no clinically relevant finding reported for Vital signs and Left ventricular ejection fraction (LVEF)."|First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks|Treated Set (TS).||percentage of participants|||Number
781642|NCT00796549|Secondary|Number of Participants With Clinical Relevant Finding in Gastrointestinal and Skin Disorder|The safety of patients was overall assessed in terms of adverse events (AEs), graded according to US NCI CTCAE version 3.0 [R04-0474], including skin reactions and gastrointestinal AEs.|First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks|Treated Set (TS).||Percentage of participants|||Number
781643|NCT00796549|Secondary|Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 15 (Cpre,ss,15)|Cpre,ss,15 represents the pre-dose concentration of afatinib in plasma at steady state on day 15.|Day 15|"Pharmacokinetic set (PK set) contains all patients who received study medication and have evaluable pharmacokinetic parameter data.
Data from patients who received the starting dose of 50 mg afatinib and were still on treatment and not dose-reduced on Day 15 are presented."||ng/mL||Geometric Coefficient of Variation|Geometric Mean
781644|NCT00796549|Secondary|Overall Survival (OS) Time|Overall survival time is defined as time from the date of start of treatment to the date of death.|Baseline until last vital status assessment 17JUN13|Treated set (TS).||Weeks||95% Confidence Interval|Median
781645|NCT00796549|Secondary|Progression Free Survival (PFS) Time|Progression Free Survival time defined as time from the start of treatment to the earliest of progression (RECIST), clinical progression (investigator), start of new anti-cancer treatment or death.|Every 8 weeks until last response assessment 28NOV12|Treated set (TS).||Weeks||95% Confidence Interval|Median
781646|NCT00796549|Secondary|Duration of Confirmed Disease Control|Duration of Disease Control is measured from the time of first Objective Response to the time of progression or death (or date of censoring for progression free survival) or respectively for SD as the time from date of randomization to date that disease progression.|Every 8 weeks until last response assessment 28NOV12|Treated set (TS).||Weeks||Standard Deviation|Mean
781647|NCT00796549|Secondary|Percentage of Participants With Disease Control (DC)|Percentage of participants with Objective response (OR) or stable disease (SD) as determined by RECIST version 1.0.|Every 8 weeks until last response assessment 28NOV12|Treated set (TS).||percentage of participants||95% Confidence Interval|Number
781648|NCT00796549|Secondary|Duration of Confirmed Objective Response (OR)|Duration of confirmed Objective Response is measured from the time of first Objective Response (OR) to the time of progression or death (or date of censoring for progression free survival).|Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks until last response assessment 28NOV12.|Treated set (TS).||Weeks||Standard Deviation|Mean
781649|NCT00796549|Secondary|Number of Participants With Objective Response (OR) Categorized by Time|Cumulative number of participants with objective response by time points with responders.|Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks until last response assessment 28NOV12.|Treated set (TS).||percentage of participants|||Number
781650|NCT00796549|Primary|Percentage of Participants With Best Objective Response|Percentage of participants with best objective response: confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.0.|Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks until last response assessment 28NOV12.|Treated set (TS). TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.||percentage of participants||95% Confidence Interval|Number
781651|NCT00796614|Secondary|Post Void Residual Volume at Week 14|Median change from baseline to Week 14 in post void residual (mL) by study treatment.|Baseline and Week 14.|Treated Set (TS). Number of particiapants Analysed are the number of participants whose data were available for this endpoint.||mL||Standard Deviation|Median
781652|NCT00796614|Secondary|Number of Participants With Clinically Relevant Abnormalities for Physical Examination, Vital Signs/Orthostatic Testing, Electorocardiogram (ECG), Laboratory Values, Urinalysis, Treatment Emergent AE's and Cognitive Testing.|"Number of participants with Clinically Relevant Abnormalities for Physical Examination, Vital Signs/Orthostatic testing (blood pressure, pulse and respiratory rate), Electrocardiogram (ECG), Laboratory Values inclusive of hormonal assays, vision testing, Cognitive Testing, Occurrence of treatment emergent adverse events, Premature discontinuation of study drug due to AE and Urinalysis.
Relevant findings or worsening of baseline conditions were reported as adverse events."|From first drug administration until 28 days after last study drug administration, upto 160 days|"Treated Set (TS).
All subjects began treatment with their low dose and then they were titrated to their randomised medium or high dose. Therefore some of the subjects were counted more than once for having reported adverse events with different doses of the study."||Participants|||Number
781653|NCT00796614|Secondary|Change From Baseline in Number of Times Patient Was Wet at Catheterisation|Change from baseline in number of times patient was wet at time of catheterisation as recorded in catheterisation diary.|Baseline and Week 14|Full analysis set-catheter (FAS-CATH)||Times patient wet at catheterization||Standard Error|Least Squares Mean
781656|NCT00796614|Secondary|Response With Regard to Hydronephrosis Was Defined as Improvement or Stabilisation Based Upon the Renal Ultrasound Grading at Week 14 (End of Treatment) Compared to Baseline|"Hydronephrosis response was defined as stabilisation or improvement of hydronephrosis measured by renal ultrasound at the end of treatment when compared to baseline, based on ultrasound grading.
The lower or same grade at end of treatment compared to baseline is considered an improvement or stabilization"|Baseline and Week 14|Full analysis set-renal (FAS-RENAL): This analysis set includes all patients in the treated set who received at least one dose of randomised treatment and had at least one on-treatment renal ultrasound measurement.||Participants|||Number
781657|NCT00796614|Secondary|Percentage Change From Baseline in LPP at Week 14 (End of Treatment)|Percent changes in detrusor leak point pressure (LPP) from baseline to the end of treatment at Week 14 between each dose group and the placebo group were compared for the FAS-LPP.|Baseline and Week 14.|Full analysis set-LPP (FAS-LPP), OT||Percentage change||Standard Error|Least Squares Mean
781658|NCT00796614|Secondary|Change From Baseline in LPP at Week 14 (End of Treatment)|Change from baseline in detrusor leak point pressure (LPP) at Week 14 (end of treatment) between each dose group and the placebo group was compared for the FAS-LPP.|Baseline and Week 14|Full analysis set-LPP (FAS-LPP), OT||cm H2O||Standard Error|Least Squares Mean
781659|NCT00796614|Primary|Response to Treatment Defined as Patients Who Decrease Their Detrusor Leak Point Pressure (LPP) to <40 cm H2O Based Upon Two Evaluations on the Same Day.|The primary endpoint was response to treatment defined as patients who decreased their detrusor leak point pressure (LPP) based upon two evaluations on the same day to less than 40 cm H2O at Week 14 (end of treatment). Detrusor leak point pressure (LPP) recorded in cm H2O was obtained using a standard urodynamic technique, a cystometrogram. On treatment (OT): Consist of all on treatment data. Observations measured ≤3 days of stopping treatment was considered as on treatment. Missing data in these analyses was not replaced or imputed.|Week 14|Full analysis set-LPP (FAS-LPP): Includes all patients in the treated set who received at least one dose of randomised. FAS-LPP contains same patients as TS.||Percentage of participants|||Number
781660|NCT00796627|Primary|Mean of Circulating Angiogenic Cells in the Blood of Individuals Who Have Sustained a Burn Injury|Tissue samples were harvested from healthy volunteers and participants who sustained burns. CACs were isolated and counted under fluorescence microscopy.|73 hours to 6 weeks post-operative|Data was only collected for the experimental arm for this outcome measure to assess the change in amount of CACs after burn injury as time progressed.||cells per standard well||Full Range|Mean
781661|NCT00796627|Primary|Mean of Circulating Angiogenic Cells in the Blood of Individuals Who Have Sustained a Burn Injury|Tissue samples were harvested from healthy volunteers and participants who sustained burns. CACs were isolated and counted under fluorescence microscopy.|49 to 72 hours post-operative|Data only collected for the experimental arm for this outcome measure to assess the change in amount of CACs after burn injury as time progressed.||cells per standard well||Full Range|Mean
781662|NCT00796627|Primary|Mean of Circulating Angiogenic Cells in the Blood of Individuals Who Have Sustained a Burn Injury|Tissue samples were harvested from healthy volunteers and participants who sustained burns. CACs were isolated and counted under fluorescence microscopy.|0 to 24 hours post-operative|Data was only collected for the experimental arm for this outcome measure to assess the change in amount of CACs after burn injury as time progressed.||cells per standard well||Full Range|Mean
781663|NCT00796627|Primary|The Quantification of Circulating Angiogenic Cells in the Blood of Individuals Who Are Healthy Volunteers Compared to Those in Individuals Who Have Sustained a Burn Injury|Tissue samples were harvested from healthy volunteers and participants who sustained burns. CACs were isolated and counted under fluorescence microscopy.|baseline|||cells per standard well||Full Range|Mean
781664|NCT00796653|Primary|Mahler Transitional Dyspnea Index Focal Score at 24 Weeks for Combined Analysis|This outcome measure describes the combined analysis of the trials NCT00793624 and NCT00796653. Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 24|Full analysis sets (FAS) of the trials NCT00793624 and NCT00796653. FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||score on a scale||Standard Error|Mean
781665|NCT00796653|Secondary|Absolute Plasma Concentrations|Absolute plasma concentrations of Olodaterol. Values presented are across visits and summarised into geometric means.|within 2 hours before first study drug administration and 10 minutes post-dose at week 6, 12 and 18|Pharmacokinetic set includes all patients in the treated set who had at least one valid olodaterol plasma concentration measurement after initial administration of study drug. This set is restricted to patients in either the Olodaterol 5 μg or 10 μg dose group.||pg/mL||Geometric Coefficient of Variation|Geometric Mean
781666|NCT00796653|Secondary|Changes in Safety Parameters Related to Treatment|Occurence of cardiac disorders and investigations related to treatment.|48 weeks|Treated set.||percentage of participants|||Number
781667|NCT00796653|Secondary|Number of Moderate Chronic Obstructive Pulmonary Disease (CPOD) Exacerbations|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations did not lead to hospitalization but included treatment with antibiotics and/or systemic steroids.|Baseline to end of study at 48 weeks.|Treated set- all patients who received at least one dose of study medication||Number of COPD ex. per patient year||Standard Error|Mean
781668|NCT00796653|Secondary|Number of COPD Exacerbations Requiring Hospitalization|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations required hospitalization.|Baseline to end of study at week 48 visit|Treated set- all patients who received at least one dose of study medication||Number of COPD ex. per patient year||Standard Error|Mean
781669|NCT00796653|Secondary|Number of COPD Exacerbations|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria.|Baseline to end of study at week 48 visit|Treated set- all patients who received at least one dose of study medication||Number of COPD ex. per patient year||Standard Error|Mean
781670|NCT00796653|Secondary|Time to First Moderate Chronic Obstructive Pulmonary Disease (CPOD) Exacerbation|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations did not lead to hospitalization but included treatment with antibiotics and/or systemic steroids. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor.|Baseline to end of study at 48 weeks.|||Days||95% Confidence Interval|Mean
781671|NCT00796653|Secondary|Time to First Chronic Obstructive Pulmonary Disease (CPOD) Exacerbation Leading to Hospitalization|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations required hospitalization. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor.|Baseline to end of study at 48 weeks.|||Days||95% Confidence Interval|Mean
781672|NCT00796653|Secondary|Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor.|Baseline to end of study at 48 weeks.|||Days||95% Confidence Interval|Mean
781673|NCT00796653|Secondary|Mahler Transitional Dyspnea Index Focal Score at 48 Weeks|Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 48|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||score on a scale||Standard Error|Least Squares Mean
781674|NCT00796653|Secondary|Mahler Transitional Dyspnea Index Focal Score at 40 Weeks|Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 40|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||score on a scale||Standard Error|Least Squares Mean
781675|NCT00796653|Secondary|Mahler Transitional Dyspnea Index Focal Score at 32 Weeks|Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 32|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||score on a scale||Standard Error|Least Squares Mean
781676|NCT00796653|Secondary|Mahler Transitional Dyspnea Index Focal Score at 18 Weeks|Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 18|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||score on a scale||Standard Error|Least Squares Mean
781677|NCT00796653|Secondary|Mahler Transitional Dyspnea Index Focal Score at 12 Weeks|Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 12|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||score on a scale||Standard Error|Least Squares Mean
781678|NCT00796653|Secondary|Mahler Transitional Dyspnea Index Focal Score at 6 Weeks|Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 6|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||score on a scale||Standard Error|Least Squares Mean
781679|NCT00796653|Secondary|Patient's Global Rating (PGR) at 48 Weeks|Patient's Global Rating (PGR) was a patient assessment of their health (respiratory condition) at each visit (compared to the day before they started study drug) and ranged from 1 (very much better) to 7 (very much worse).|Week 48|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||score on a scale||Standard Error|Least Squares Mean
781680|NCT00796653|Secondary|Patient's Global Rating (PGR) at 24 Weeks|Patient's Global Rating (PGR) was a patient assessment of their health (respiratory condition) at each visit (compared to the day before they started study drug) and ranged from 1 (very much better) to 7 (very much worse).|Week 24|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||score on a scale||Standard Error|Least Squares Mean
781681|NCT00796653|Secondary|Patient's Global Rating (PGR) at 12 Weeks|Patient's Global Rating (PGR) was a patient assessment of their health (respiratory condition) at each visit (compared to the day before they started study drug) and ranged from 1 (very much better) to 7 (very much worse).|Week 12|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||score on a scale||Standard Error|Least Squares Mean
781682|NCT00796653|Secondary|Patient's Global Rating (PGR) at 6 Weeks|Patient's Global Rating (PGR) was a patient assessment of their health (respiratory condition) at each visit (compared to the day before they started study drug) and ranged from 1 (very much better) to 7 (very much worse).|Week 6|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||score on a scale||Standard Error|Least Squares Mean
781683|NCT00796653|Secondary|Use of Rescue Medication at Week 24|Mean number of puffs of rescue medication used per day (daytime/nighttime/total)|Week 24|FAS||Number of puffs||Standard Error|Mean
781684|NCT00796653|Secondary|Peak Expiratory Flow Rate (PEFR) at Week 24|Weekly mean pre-dose morning and evening PEFR. Results are from non−MMRM ANCOVA models by week, with Last observation carried forward (LOCF) up to each week. Fixed effects include treatment, tiotropium, strata and baseline.|Week 24|FAS||L/min||Standard Error|Mean
781685|NCT00796653|Secondary|Peak FVC (0-3h) Response After 48 Weeks|Response was defined as change from baseline. Baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
781686|NCT00796653|Secondary|Peak FVC (0-3h) Response After 24 Weeks|Response was defined as change from baseline. Baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
781687|NCT00796653|Secondary|Peak FVC (0-3h) Response After 12 Weeks|Response was defined as change from baseline. Baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 12 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
781688|NCT00796653|Secondary|Peak FVC (0-3h) Response After 6 Weeks|Response was defined as change from baseline. Baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
781689|NCT00796653|Secondary|Peak FVC (0-3h) Response After 2 Weeks|Response was defined as change from baseline. Baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
781690|NCT00796653|Secondary|Trough FVC Response at Week 48|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 48.|FAS||Liter||Standard Error|Least Squares Mean
781691|NCT00796653|Secondary|Trough FVC Response at Week 40|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 40.|FAS||Liter||Standard Error|Least Squares Mean
781692|NCT00796653|Secondary|Trough FVC Response at Week 32|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 32.|FAS||Liter||Standard Error|Least Squares Mean
781693|NCT00796653|Secondary|Trough FVC Response at Week 24|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 24.|FAS||Liter||Standard Error|Least Squares Mean
781694|NCT00796653|Secondary|Trough FVC Response at Week 18|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 18.|FAS||Liter||Standard Error|Least Squares Mean
781695|NCT00796653|Secondary|Trough FVC Response at Week 12|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 12.|FAS||Liter||Standard Error|Least Squares Mean
781696|NCT00796653|Secondary|Trough FVC Response at Week 6|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 6.|FAS||Liter||Standard Error|Least Squares Mean
781697|NCT00796653|Secondary|Trough FVC Response at Week 2|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 2.|FAS||Liter||Standard Error|Least Squares Mean
781698|NCT00796653|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 48 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 48|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
781722|NCT00796653|Secondary|Saint George's Respiratory Questionnaire (SGRQ) Total Score at 24 Weeks|Saint George's Respiratory Questionnaire (SGRQ) measures the impact of COPD on overall health, daily life, and perceived well-being ranging from 0 (no limitations) to 100 (most limitations).|Baseline, Week 24|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||score on a scale||Standard Error|Least Squares Mean
781699|NCT00796653|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 24 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 24|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
781700|NCT00796653|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 12 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 12|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
781701|NCT00796653|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 6 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 6|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
781702|NCT00796653|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 2 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 2|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
781703|NCT00796653|Secondary|Peak FEV1 (0-3h) Response After 48 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
781704|NCT00796653|Secondary|Peak FEV1 (0-3h) Response After 24 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
781705|NCT00796653|Secondary|Peak FEV1 (0-3h) Response After 12 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 12 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
781706|NCT00796653|Secondary|Peak FEV1 (0-3h) Response After 6 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
781707|NCT00796653|Secondary|Peak FEV1 (0-3h) Response After 2 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
781708|NCT00796653|Secondary|Trough FEV1 Response at Week 48|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 48.|FAS||Liter||Standard Error|Least Squares Mean
781709|NCT00796653|Secondary|Trough FEV1 Response at Week 40|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 40.|FAS||Liter||Standard Error|Least Squares Mean
781710|NCT00796653|Secondary|Trough FEV1 Response at Week 32|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 32.|FAS||Liter||Standard Error|Least Squares Mean
781711|NCT00796653|Secondary|Trough FEV1 Response at Week 18|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 18.|FAS||Liter||Standard Error|Least Squares Mean
781712|NCT00796653|Secondary|Trough FEV1 Response at Week 12|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 12.|FAS||Liter||Standard Error|Least Squares Mean
781713|NCT00796653|Secondary|Trough FEV1 Response at Week 6|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 6.|FAS||Liter||Standard Error|Least Squares Mean
781758|NCT00796757|Secondary|OS - Percentage of Participants With an Event|OS was defined as the time period from the first bevacizumab infusion to death from any cause. Censoring at start of any subsequent antineoplastic therapy was not performed.|Day 0, every 2 weeks until disease progression or end of treatment visit (28 days after last bevacizumab infusion, every 3 months during follow-up, or a maximum of 2 years from enrollment of last participant|ITT population||percentage of participants|||Number
781714|NCT00796653|Secondary|Trough FEV1 Response at Week 2|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 2.|FAS||Liter||Standard Error|Least Squares Mean
781715|NCT00796653|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 48 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 48|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
781716|NCT00796653|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 12 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 12|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
781717|NCT00796653|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 6 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 6|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
781718|NCT00796653|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 2 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 2|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
781719|NCT00796653|Secondary|Saint George's Respiratory Questionnaire (SGRQ) Total Score at 24 Weeks for Combined Analysis|Saint George's Respiratory Questionnaire (SGRQ) measures the impact of COPD on overall health, daily life, and perceived well-being ranging from 0 (no limitations) to 100 (most limitations). This is a combined analysis of the data from NCT00793624 and NCT00796653 showing adjusted values using a MMRM model.|Baseline, Week 24|Full analysis sets (FAS) of the trials NCT00793624 and NCT00796653. FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||score on a scale||Standard Error|Least Squares Mean
781720|NCT00796653|Secondary|Saint George's Respiratory Questionnaire (SGRQ) Total Score at 12 Weeks|Saint George's Respiratory Questionnaire (SGRQ) measures the impact of COPD on overall health, daily life, and perceived well-being ranging from 0 (no limitations) to 100 (most limitations).|Baseline, Week 12|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||score on a scale||Standard Error|Least Squares Mean
781721|NCT00796653|Secondary|Saint George's Respiratory Questionnaire (SGRQ) Total Score at 48 Weeks|Saint George's Respiratory Questionnaire (SGRQ) measures the impact of COPD on overall health, daily life, and perceived well-being ranging from 0 (no limitations) to 100 (most limitations).|Baseline, Week 48|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||score on a scale||Standard Error|Least Squares Mean
781723|NCT00796653|Primary|Mahler Transitional Dyspnea Index Focal Score at 24 Weeks|Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 24|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||score on a scale||Standard Error|Least Squares Mean
781724|NCT00796653|Primary|Trough FEV1 Response at Week 24|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 24.|FAS||Liter||Standard Error|Least Squares Mean
781725|NCT00796653|Primary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 24 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 24|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
781726|NCT00796666|Secondary|Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Composite Physical Health|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Composite Physical Health score at Week x minus score at baseline.|Baseline, Weeks 12, 24 or ET|ITT; N=number of participants analyzed||units on a scale||Standard Deviation|Mean
781727|NCT00796666|Secondary|Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Composite Mental Health|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Composite Mental Health score at Week x minus score at baseline.|Baseline, Weeks 12, 24 or ET|ITT; N=number of participants analyzed||units on a scale||Standard Deviation|Mean
781728|NCT00796666|Secondary|Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Mental Health Domain|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Mental Health score at Week x minus score at baseline.|Baseline, Weeks 12, 24 or ET|ITT; N=number of participants analyzed||units on a scale||Standard Deviation|Mean
781729|NCT00796666|Secondary|Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Role Limitation Due to Emotional Problems Domain|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Role Limitations Due to Emotional Problems score at Week x minus score at baseline.|Baseline, Weeks 12, 24 or ET|ITT; N=number of participants analyzed||units on a scale||Standard Deviation|Mean
781730|NCT00796666|Secondary|Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Social Functioning Domain|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Social Functioning score at Week x minus score at baseline.|Baseline, Weeks 12, 24 or ET|ITT; N=number of participants analyzed||units on a scale||Standard Deviation|Mean
781731|NCT00796666|Secondary|Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Vitality Domain|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Vitality score at Week x minus score at baseline.|Baseline, Weeks 12, 24 or ET|ITT; N=number of participants analyzed||units on a scale||Standard Deviation|Mean
781732|NCT00796666|Secondary|Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - General Health Domain|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = General Health score at Week x minus score at baseline.|Baseline, Weeks 12, 24 or ET|ITT; N=number of participants analyzed||units on a scale||Standard Deviation|Mean
781733|NCT00796666|Secondary|Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Bodily Pain Domain|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Bodily Pain score at Week x minus score at baseline.|Baseline, Weeks 12, 24 or ET|ITT; N=number of participants analyzed||units on a scale||Standard Deviation|Mean
781734|NCT00796666|Secondary|Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Role Limitations Due to Physical Health Problems Domain|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Role Limitations Due to Physical Health Problems score at Week x minus score at baseline.|Baseline, Weeks 12, 24 or ET|ITT; N=number of participants analyzed||units on a scale||Standard Deviation|Mean
781735|NCT00796666|Secondary|Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Physical Functioning Domain|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Physical Functioning score at Week x minus score at baseline.|Baseline, Weeks 12, 24 and ET|ITT; N=number of participants analyzed||units on a scale||Standard Deviation|Mean
781736|NCT00796666|Secondary|Change From Baseline in World Health Organization (WHO) Functional Class in Participants With PAH at Weeks 12, 24, 48|WHO PAH Functional Classification of physical activity limitations: I (no limitation), II (slight limitation), III (marked limitations, comfortable at rest) and IV (unable to carry out any physical activity without symptoms). The change from baseline in WHO class was classified as Improved (decrease in functional class), No Change (functional class stayed the same), and Worsened (functional class increased). The change from baseline in WHO functional class at Week X was summarized with frequency count and percentage in each category based on imputed data for missing values at Week X.|Baseline, Weeks 12, 24 or ET|ITT||participant|||Number
781737|NCT00796666|Secondary|Change From Baseline in the Total Distance Walked During 6 Minute Walk Distance (6MWD)|6 MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. Continuous pulse oximetry was conducted during the test for safety. Change from baseline = score at Week x - score at baseline.|Baseline to Weeks 12 and 24|ITT; N=number of participants analyzed; Missing values at Weeks 12 and 24 imputed with the last non-missing 6MWD based on the last observation carried forward (LOCF) method||meters (m)||Standard Deviation|Mean
781738|NCT00796666|Primary|Time to Clinical Worsening (TTCW)|Clinical worsening defined as time between first dose of study drug and occurrence of death; or heart-lung/lung transplant; or hospitalization for worsening pulmonary atrial hypertension (PAH); or atrial septostomy; or withdrawal due to addition of chronic medications for treatment of worsening PAH: prostacyclin/prostacyclin analogues/phosphodiesterase-5inhibitors/alternative endothelin receptor antagonists/intravenous inotropes; or increase of calcium channel blockers or oxygen. TTCW measured as duration between study’s first dose date in and date when first clinical worsening event occurs.|Baseline, Weeks 12, 24 or Early Termination (ET)|Intent-to-Treat population (ITT): all participants who were randomized||Days||Full Range|Median
781739|NCT00796705|Secondary|Participants With an ACR 70 Response at Week 12|"The American College of Rheumatology (ACR) 70 Responder Index is defined as someone who achieved at least 70% improvement in the tender and swollen 28- joint count, and 70% improvement in at least three of the following the following 5 measures:
Patient's pain assessment (Visual Analogue Scale (VAS) 100 mm)
Patient's global assessment of disease activity (VAS 100 mm)
Physician's global assessment of disease activity (VAS 100 mm)
Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)
Acute phase reactant (CRP)"|Week 12|Intent-to-treat||participants|||Number
781740|NCT00796705|Secondary|Participants With an ACR 50 Response at Week 12|"The American College of Rheumatology (ACR) 50 Responder Index is defined as someone who achieved at least 50% improvement in the tender and swollen 28-joint count, and 50% improvement in at least three of the following 5 measures:
Patient's pain assessment (Visual Analogue Scale (VAS) 100 mm)
Patient's global assessment of disease activity (VAS 100 mm)
Physician's global assessment of disease activity (VAS 100 mm)
Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)
Acute phase reactant (CRP)"|Week 12|Intent-to-treat||participants|||Number
781741|NCT00796705|Secondary|Participants With an ACR 20 Response at Week 12|"The American College of Rheumatology (ACR) 20 Responder Index is defined as someone who achieved at least 20% improvement in the tender and swollen 28-joint count, and 20% improvement in at least three of the following 5 measures:
Patient's pain assessment (Visual Analogue Scale (VAS) 100 mm)
Patient's global assessment of disease activity (VAS 100 mm)
Physician's global assessment of disease activity (VAS 100 mm)
Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)
Acute phase reactant (CRP)"|Week 12|Intent-to-treat||participants|||Number
781742|NCT00796705|Secondary|Participants With a Decrease in Disease Activity Score Using C-reactive Protein (DAS28[CRP]) Value of >1.2 From Baseline to Week 12 (European League Against Rheumatism (EULAR) Definition of a Moderate Response)|The EULAR definition of a Moderate Response is a decrease from baseline in the DAS28[CRP] value of ≥ 1.2.|Baseline, Week 12|Intent-to-treat||participants|||Number
781743|NCT00796705|Secondary|Participants With a Disease Activity Score Using C-reactive Protein (DAS28[CRP]) Value < 2.6 (Remission) at Week 12|The DAS28 is a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (>5.1=high disease activity; <=3.2=low disease activity; <2.6=remission); a continuous variable which is a composite of 4 variables(the number of tender joints out of 28, the number of swollen joints out of 28 joints, serum C-reactive protein in mg/L (CRP) and subject assessment of disease activity measure on a visual analogue scale (VAS) of 100 mm).|Week 12|Intent-to-treat||participants|||Number
781824|NCT00797316|Secondary|Percentage of Participants With Blood Pressure Response at Week 8|Response is defined as a patient with msSBP < 140 mmHg or a decrease from baseline ≥ 20 mmHg in msSBP during eight weeks of treatment.|8 weeks|full analysis set||Percentage of Participants|||Number
781744|NCT00796705|Secondary|Participants With a Disease Activity Score Using C-reactive Protein (DAS28[CRP]) Value <= 3.2 (Low Disease Activity) at Week 12|The DAS28 is a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (>5.1=high disease activity; <=3.2=low disease activity; <2.6=remission); a continuous variable which is a composite of 4 variables(the number of tender joints out of 28, the number of swollen joints out of 28 joints, serum C-reactive protein in mg/L (CRP) and subject assessment of disease activity measure on a visual analogue scale (VAS) of 100 mm).|Week 12|Intent-to-treat||participants|||Number
781745|NCT00796705|Primary|Change in the Disease Activity Score Using C-reactive Protein (DAS28[CRP]) From Baseline to Week 12.|The DAS28 is a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (>5.1=high disease activity; <=3.2=low disease activity; <2.6=remission); a continuous variable which is a composite of 4 variables(the number of tender joints out of 28, the number of swollen joints out of 28 joints, serum C-reactive protein in mg/L (CRP) and subject assessment of disease activity measure on a visual analogue scale (VAS) of 100 mm).|Baseline, Week 12|Intent-to-treat||Scores on a scale||Standard Deviation|Mean
781746|NCT00796705|Primary|Change in the Disease Activity Score Using C-reactive Protein (DAS28[CRP]) From Baseline to Week 12 in Non-Switchers Versus Switchers.|The DAS28 is a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (>5.1=high disease activity; <=3.2=low disease activity; <2.6=remission); a continuous variable which is a composite of 4 variables(the number of tender joints out of 28, the number of swollen joints out of 28 joints, serum C-reactive protein in mg/L (CRP) and subject assessment of disease activity measure on a visual analogue scale (VAS) of 100 mm).|Baseline, Week 12|Intent-to-treat||Scores on a scale||Standard Deviation|Mean
781747|NCT00796718|Secondary|Percentage of Participants With Adverse Events|An adverse event was defined as any untoward medical occurrence in a participant administered the investigational product which does not necessarily have a causal relationship with this treatment.|Up to 15 weeks|All enrolled participants.||percentage of participants|||Number
781748|NCT00796718|Secondary|Percentage of Participants With Response to the Treatment Assessed 1 Month After Surgery (Complete Response, Partial Remission or No Response to the Treatment)|Complete response was defined as the disappearance of all target and non-target lesions. Partial remission was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of target lesions, taking as reference the baseline SLD, or the persistence of 1 or more non-target lesions. No response to treatment was defined as neither sufficient shrinkage to qualify for partial remission nor sufficient increase to qualify for progressive disease, compared to the baseline SLD.|Up to 15 weeks (assessed 1 month after surgery)|Participants with available data.||percentage of participants|||Number
781749|NCT00796718|Secondary|Percentage of Participants With Response to Treatment Assessed 4-6 Weeks After the Completion of Radiochemotherapy (Complete Response, Partial Remission or No Response to the Treatment)|Complete response was defined as the disappearance of all target and non-target lesions. Partial remission was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of target lesions, taking as reference the baseline SLD, or the persistence of 1 or more non-target lesions. No response to treatment was defined as neither sufficient shrinkage to qualify for partial remission nor sufficient increase to qualify for progressive disease, compared to the baseline SLD.|Up to 11 weeks (assessed 4-6 weeks after the completion of radiochemotherapy)|Participants with available data.||percentage of participants|||Number
781750|NCT00796718|Primary|Percentage of Participants With Pathological Complete Response|Pathological complete response was defined as the absence of viable tumor cells in the tumor specimen, including regional lymph nodes determined with standard histological procedures.|Up to 11 weeks (assessed at the time of post-treatment surgery)|Participants with available data.||percentage of participants|||Number
781751|NCT00796744|Secondary|The Time to Re-epithelialization of the Ulcer Site.|Average time to complete re-epithelialization of baseline ulcer area.|24 weeks|||Weeks||Standard Error|Mean
781752|NCT00796744|Secondary|The Rate of Re-epithelialization of the Ulcer Site.|The overall healing rate of the ulcers, based on the percent of unhealed ulcer area re-epithelialized per week.|12 weeks|||percent ulcer area re-epithelialized/wk||Standard Deviation|Mean
781753|NCT00796744|Secondary|The Proportion of Subjects in Each Treatment Group Reporting Adverse Events.||Duration of subject's participation (24 weeks)|Safety Population||patients|||Number
781754|NCT00796744|Primary|The Primary Efficacy Parameter Will be the Proportion of Ulcers Healed by 12 Weeks as Defined as 100 % Epithelialized With no Drainage.||Healing to occur within 12 weeks of first treatment|Intent-to-Treat Population||number of ulcers healed|||Number
781755|NCT00796757|Secondary|EQ-5D - Visual Analog Scale (VAS)|EQ-5D: participant-rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 millimeters (mm) (best imaginable health state); higher scores indicate a better health state. Participants were asked to rate their health state and mark the line; the distance from the left edge was recorded. For change from baseline a negative value represents a worsening in the health state and a positive value represents an improvement in the health state.|Screening/Baseline, Cycle 7, Cycle 25, Cycle 43, Cycle 61, and EOT|ITT population; n=number of participants assessed for the specified parameter at a given visit.||mm||Standard Deviation|Mean
781756|NCT00796757|Secondary|Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit|EQ-5D is a standardized, participant-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point visual analog scale (0=worst, 100=best). Answers from the questionnaire for each dimension (mobility, self-care, usual activity, pain/discomfort, and anxiety/depression) was classified into one of 2 categories: 'no problems' or 'any problems', and the percentage of participants in each category was determined.|Screening/Baseline, Cycle 7, Cycle 25, Cycle 43, Cycle 61, and End of Treatment (EOT)|ITT population; number (n) equals (=) number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
781757|NCT00796757|Secondary|OS - Time to Event|OS was defined as the time period from the first bevacizumab infusion to death from any cause. Censoring at start of any subsequent antineoplastic therapy was not performed.|Day 0, every 2 weeks until disease progression or end of treatment visit (28 days after last bevacizumab infusion, every 3 months during follow-up, or a maximum of 2 years from enrollment of last participant|ITT population||months||95% Confidence Interval|Median
781759|NCT00796757|Secondary|Overall Survival (OS) - Percentage of Participants Estimated to be Alive at 12 and 24 Months|OS at 12 and 24 months is the estimate of the percentages of participants expected to alive at 12 and 24 months based on Kaplan-Meier survival analysis of the survival data. Median OS was defined as the time period from the first bevacizumab infusion to death from any cause. Censoring at start of any subsequent antineoplastic therapy was not performed.|Day 0, every 2 weeks until disease progression or end of treatment visit (28 days after last bevacizumab infusion, every 3 months during follow-up, or a maximum of 2 years from enrollment of last participant|ITT population||percentage of participants||95% Confidence Interval|Number
781760|NCT00796757|Primary|PFS - Time to Event|PFS was defined as the time period from the first postbaseline assessment tumor assessment to evidence of disease progression or death from any cause, whichever occurred first. Disease progression included evaluation solely due to symptomatic deterioration or death due to any reason. Censoring at start of any subsequent antineoplastic therapy was not performed.|Baseline, every 8 weeks to Week 32 then every 12 weeks to disease progression or a maximum of 2 years from enrollment of last participant|ITT population||months||95% Confidence Interval|Median
781761|NCT00796757|Primary|PFS - Percentage of Participants With an Event|PFS was defined as the time period from the first postbaseline assessment tumor assessment to evidence of disease progression or death from any cause, whichever occurred first. Disease progression included evaluation solely due to symptomatic deterioration or death due to any reason. Censoring at start of any subsequent antineoplastic therapy was not performed.|Baseline, every 8 weeks to Week 32 then every 12 weeks to disease progression or a maximum of 2 years from enrollment of last participant|ITT population||percentage of participants|||Number
781762|NCT00796757|Secondary|Percentage of Participants With a Best Overall Response of Complete Reponse (CR) or Partial Response (PR)|Percentage of participants with objective response, termed responders, based assessment of confirmed CR or confirmed PR according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses were those that persisted on repeat imaging study greater than or equal to (≥)4 weeks after initial documentation of response. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal (short axis less than [<]10 millimeters [mm]). No new lesions. PR was defined as ≥30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.|Baseline, every 8 weeks to Week 32 then every 12 weeks to disease progression or a maximum of 2 years from enrollment of last participant|ITT population; only participants with measurable disease were included in the analysis.||percentage of participants|||Number
781763|NCT00796757|Primary|Progression-Free Survival (PFS) - Percentage of Participants Estimated to be Progression Free at 12 and 24 Months|PFS at 12 and 24 months is an estimate of the percentages of participants expected to be progression free at 12 and 24 months based on Kaplan-Meier survival analysis of the PFS data. PFS was defined as the time period from the first postbaseline tumor assessment to evidence of disease progression or death from any cause, whichever occurred first. Disease progression included evaluation solely due to symptomatic deterioration or death due to any reason. Censoring at start of any subsequent antineoplastic therapy was not performed.|12 and 24 months|ITT population||percentage of participants||95% Confidence Interval|Number
781764|NCT00796822|Secondary|Safety and Tolerability||Measured at Weeks 4 and 8||||||
781765|NCT00796822|Secondary|Metabolics (i.e., Fasting Lipid Profile, Glucose, Insulin)||Measured at baseline and Weeks 4 and 8||||||
781766|NCT00796822|Secondary|Inflammatory Biomarkers (i.e., MCP-1, sVCAM-1, IP-10, MMP-9, TIMP-1, PAI-1 Active, hsCRP)||Measured at baseline and Weeks 4 and 8||||||
781767|NCT00796822|Secondary|Immunologic Parameters (i.e., Activated CD8 Cell Percentage, CD4 Cell Count)||Measured at baseline and Weeks 4 and 8||||||
781768|NCT00796822|Primary|Change in Flow-mediated Dilation of the Brachial Artery|Flow-mediated dilation is nn in vivo measure of arterial endothelial function. We assessed changes in flow-mediated dilation from baseline to week 8.|Measured at baseline and Week 8|Number of remaining participants at week 8 with evaluable vascular ultrasonography. In the Pentoxifylline group, 10 participants were evaluated at week 8 but only 9 had evaluable ultrasonography.||absolute percentage||Standard Deviation|Mean
781769|NCT00796926|Secondary|Superior and Inferior Tear Meniscus Height|This is determined by anterior segment OCT visante system|6 weeks||||||
781770|NCT00796926|Secondary|Tear Osmolarity|This is measured by the TearLab (Ocusense) system|6 weeks||||||
781771|NCT00796926|Secondary|Meibography Grading||6 weeks||||||
781772|NCT00796926|Secondary|Schirmer I Reading||6 weeks||||||
781773|NCT00796926|Secondary|Tear Break Up Time (TBUT)||6 weeks||||||
781774|NCT00796926|Secondary|Corneal Fluorescein Staining Score|This is graded in the 5 zones of each cornea according to number of spots of corneal fluorescein staining, confluency of spots and presence of filaments if any|6 weeks||||||
781775|NCT00796926|Primary|Visual Analog Score (VAS)|Global score calculated from square root( square of (discomfort severityX Sqr(symptom frequency)) Scale from 0 to 100 higher value indicates more adverse symptoms each subscale severity or frequency also has same minimum and maximum|6 weeks|intention to treat||scores on a scale||Standard Deviation|Mean
781776|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Uric Acid - All Treated Population|Uric acid was measured as milligrams per deciliter (mg/dL). National Cancer Institute Common Terminology Criteria (CTC) v3.0 was used to determine Grade. GRADE (1): > 1.0 * ULN - 10.0; GRADE (4): > 10.0 mg/dL.|Day 1 to Week 48|Treated participants received at least one dose of a study drug.||participants|||Number
781777|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Total Lipase - All Treated Population|Total Lipase (as measured with a turbidimetric assay) was measured as units per liter (U/L). National Cancer Institute Common Terminology Criteria (CTC) v3.0 was used to determine Grade. GRADE (1): > 1.0 - 1.5 * ULN; GRADE (2): > 1.5 - 2.0 * ULN; GRADE (3): > 2.0 - 5.0 * ULN; GRADE (4): > 5.0 X ULN.|Day 1 to Week 48|Treated participants received at least one dose of a study drug.||participants|||Number
781825|NCT00797316|Secondary|Change From Baseline to Week 8 in Mean Sitting Diastolic Blood Pressure (msDBP)||8 weeks|Full analysis set||mm Hg||Standard Error|Least Squares Mean
781778|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Total Calcium (High) - All Treated Population|Total Calcium was measured as milligrams per deciliter (mg/dL). National Cancer Institute Common Terminology Criteria (CTC) v3.0 was used to determine Grade. GRADE (1): 8.0 - < LLN OR > ULN - 11.5; GRADE (2): 7.0 - < 8.0 > 11.5 - 12.5; GRADE (3): 6.0 - < 7.0 > 12.5 - 13.5; GRADE (4): < 6.0 > 13.5 mg/dL.|Day 1 to Week 48|Treated participants received at least one dose of a study drug.||participants|||Number
781779|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Total Amylase - All Treated Population|Amylase was measured as units per liter (U/L). National Cancer Institute Common Terminology Criteria (CTC) v3.0 was used to determine Grade. GRADE (1): > 1.0 - 1.5 * upper limits of normal (ULN); GRADE (2): > 1.5 - 2.0 * ULN; GRADE (3): > 2.0 - 5.0 * ULN; GRADE (4): > 5.0 * ULN.|Day 1 to Week 48|Treated participants received at least one dose of a study drug.||participants|||Number
781780|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Serum Potassium (High) - All Treated Population|Serum potassium was measured as milliequivalents per liter (mEq/L). National Cancer Institute Common Terminology Criteria (CTC) v3.0 was used to determine Grade. GRADE (1): 3.0 - < LLN OR > ULN - 5.5;; GRADE (2): > 5.5 - 6.0; GRADE (3): 2.5 - < 3.0 > 6.0 - 7.0; GRADE (4): < 2.5 mEq/L.|Day 1 to Week 48|Treated participants received at least one dose of a study drug.||participants|||Number
781781|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Total Bilirubin - All Treated Population|Total Bilirubin was measured as milligrams per deciliter (mg/dL). National Cancer Institute Common Terminology Criteria (CTC) v3.0 was used to determine Grade. GRADE (1): > 1.0 - 1.5 * upper limits of normal (ULN); GRADE (2): > 1.5 - 3.0 * ULN; GRADE (3): > 3.0 - 10.0 * ULN; GRADE (4): > 10.0 * ULN.|Day 1 to Week 48|Treated participants received at least one dose of a study drug.||participants|||Number
781782|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Alkaline Phosphatase - All Treated Population|Alkaline Phosphatase was measured as Units per Liter (U/L). National Cancer Institute Common Terminology Criteria (CTC) v3.0 was used to determine Grade. GRADE (1): > 1.0 - 2.5 * upper limits of normal (ULN); GRADE (2): > 2.5 - 5.0 * ULN; GRADE (3): > 5.0 - 20.0 * ULN; GRADE (4): > 20.0 * ULN.|Day 1 to Week 48|Treated participants received at least one dose of a study drug.||participants|||Number
781783|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Albumin - All Treated Population|Albumin was measured in grams per deciliter (g/dL). National Cancer Institute Common Terminology Criteria (CTC) v3.0 was used to determine Grade. GRADE (1): < LLN - 3.0; GRADE (2): < 3.0 - 2.0; GRADE (3): < 2.0 g/dL.|Day 1 to Week 48|||participants|||Number
781784|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Aspartate Aminotransferase (AST) - All Treated Population|AST was measured as Units per Liter (U/L). National Cancer Institute Common Terminology Criteria (CTC) v3.0 was used to determine Grade. GRADE (1): > 1.0 - 2.5 * upper limits of normal (ULN); GRADE (2): > 2.5 - 5.0 * ULN; GRADE (3): > 5.0 - 20.0 * ULN; GRADE (4): > 20.0 * ULN.|Day 1 to Week 48|||participants|||Number
781785|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Alanine Aminotransferase (ALT) - All Treated Population|ALT was measured as Units per Liter (U/L). National Cancer Institute Common Terminology Criteria (CTC) v3.0 was used to determine Grade. GRADE (1): > 1.0 - 2.5 * upper limits of normal (ULN); GRADE (2): > 2.5 - 5.0 * ULN; GRADE (3): > 5.0 - 20.0 * ULN; GRADE (4): > 20.0 * ULN.|Day 1 to Week 48|Treated participants received at least one dose of a study drug.||participants|||Number
781786|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Platelet Count - All Treated Population|Platelets were measured as *10^9 cells per liter (c/L). National Cancer Institute Common Terminology Criteria (CTC) v3.0 was used to determine Grade. GRADE (1): 75.0 - < LLN; GRADE (2): 50.0 - < 75.0; GRADE (3): 25.0 - < 50.0; GRADE (4): < 25.0.|Day 1 to Week 48|Treated participants received at least one dose of a study drug.||participants|||Number
781787|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Neutrophils Plus Bands - All Treated Population|Neutrophils plus bands (absolute) were measured as *10^3 cells per microliter (c/µL). National Cancer Institute Common Terminology Criteria (CTC) v3.0 was used to determine Grade. GRADE (1): 1.5 - < 2.0; GRADE (2): 1.0 - < 1.5; GRADE (3): 0.5 - < 1.0; GRADE (4): < 0.5.|Day 1 to Week 48|||participants|||Number
781788|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Neutrophils - All Treated Population|Neutrophils (absolute) are measured as *10^3 cells per microliter (c/µL). National Cancer Institute Common Terminology Criteria (CTC) v3.0 was used to determine Grade. GRADE (1): 1.5 - < 2.0; GRADE (2): 1.0 - < 1.5; GRADE (3): 0.5 - < 1.0; GRADE (4): < 0.5|Day 1 to Week 48|Treated participants received at least one dose of a study drug.||participants|||Number
781789|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst Common Terminology Criteria (CTC) Grade for Lymphocytes - All Treated Population|Lymphocytes (absolute) were measured as *10^3 cells per microliter (c/µL). National Cancer Institute Common Terminology Criteria (CTC) version (v) 3.0 was used to determine Grade. GRADE (1): 0.8 - < 1.5; GRADE (2): 0.5 - < 0.8; GRADE (3): 0.2 - < 0.5; GRADE (4): < 0.2|Day 1 to Week 48|Treated participants received at least one dose of a study drug.||participants|||Number
781790|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst Common Terminology Criteria (CTC) Grade for Leukocytes - All Treated Population|Leukocytes are measured as *10^3 cells per microliter (c/µL). National Cancer Institute Common Terminology Criteria (CTC) version (v) 3.0 was used to determine Grade. GRADE (1): 3.0 - < LLN; GRADE (2): 2.0 - < 3.0; GRADE (3): 1.0 - < 2.0; GRADE (4): < 1.0.|Day 1 to Week 48|Treated participants received at least one dose of a study drug.||participants|||Number
781791|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst Common Terminology Criteria (CTC) Grade for Hemoglobin - All Treated Population|Hemoglobin was measured in grams per deciliter (g/dL). National Cancer Institute Common Terminology Criteria (CTC) v3.0 was used to determine Grade. GRADE (1): 10.0 - less than (<) lower limit of normal (LLN); GRADE (2): 8.0 - < 10.0; GRADE (3): 6.5 - < 8.0; GRADE (4): < 6.5|Day 1 to Week 48|||participants|||Number
781792|NCT00796991|Secondary|Mean Baseline Change in Body Temperature at Weeks 16 and 48 - All Treated Population|Temperature was obtained while the participant was sitting down and was measured in degrees Fahrenheit (F). During the induction phase this vital sign was collected 30 minutes prior to dosing and every 30 minutes for the duration of the ipilimumab infusion. Temperature was recorded at Weeks 1, 4, 7, 10, 13, 16, 19, and 22 during the Induction Phase, and at Weeks 24, 36, and 48 during the Maintenance Phase.|Day 1 to Week 48|Treated participants received at least one dose of a study drug. N=number of treated participants who also had a temperature value available for analysis.||degrees F||Standard Deviation|Mean
781793|NCT00796991|Secondary|Mean Change From Baseline in Respiration Rate at Weeks 16 and 48 - All Treated Population|Respiration rate was obtained while the participant was sitting down and measured in breaths per minute (bpm). During the induction phase respiration rate was collected 30 minutes prior to dosing and every 30 minutes for the duration of the ipilimumab infusion. Respiration rate was recorded at Weeks 1, 4, 7, 10, 13, 16, 19, and 22 during the Induction Phase, and at Weeks 24, 36, and 48 during the Maintenance Phase.|Day 1 to Week 48|Treated participants received at least one dose of a study drug. N=number of treated participants who also had a Respiration rate value available for analysis.||bpm||Standard Deviation|Mean
781794|NCT00796991|Secondary|Mean Change From Baseline in Pulse Rate at Weeks 16 and 48 - All Treated Population|Pulse rate was obtained while the participant was sitting down and measured in beats per minute (bpm). During the induction phase pulse rate was collected 30 minutes prior to dosing and every 30 minutes for the duration of the ipilimumab infusion. Pulse rate was recorded at Weeks 1, 4, 7, 10, 13, 16, 19, and 22 during the Induction Phase, and at Weeks 24, 36, and 48 during the Maintenance Phase.|Day 1 to Week 48|Treated participants received at least one dose of a study drug. N=number of treated participants who also had a Pulse rate value available for analysis.||bpm||Standard Deviation|Mean
781795|NCT00796991|Secondary|Mean Change From Baseline at Weeks 16 and 48 in Diastolic and Systolic Blood Pressure - All Treated Population|Blood pressure was obtained while the participant was sitting down and was measured in millimeters of mercury (mmHg). During the induction phase blood pressure was collected 30 minutes prior to dosing and every 30 minutes for the duration of the ipilimumab infusion. Orthostatic blood pressure was to be measured when clinically indicated (for example, participant was experiencing lightheadedness, dizziness, syncope). Blood pressures were recorded at Weeks 1, 4, 7, 10,13, 16, 19, and 22 during the Induction Phase, and at Weeks 24, 36, and 48 during the Maintenance Phase.|Day 1 to Week 48|Treated participants received at least one dose of a study drug. N=number of treated participants who also had blood pressure value available for analysis.||mmHg||Standard Deviation|Mean
781796|NCT00796991|Secondary|Mean Absolute Lymphocyte Count (ALC) at Each Nominal Ipilimumab Induction Dose and at End of the Induction Period - Pharmacodynamic Population|Absolute lymphocyte counts were obtained from routine hematology panels from 28 days prior to the first treatment with any study medication through the end of the Induction-Dosing Period and were reported as number*10^3 cells per micro liter (x10^3 c/µL).|Day to Week 12|"Pharmacodynamic Population: All treated participants with one unambiguous date of first dose; and at least 1 ALC evaluation during the induction-dosing period. For each of these participants, all ALC evaluations from 28 days prior to first dose of any study medication to the end of the induction dosing are included.
period."||10^3 cells/µL||95% Confidence Interval|Mean
781797|NCT00796991|Secondary|Number of Participants With Adverse Events, Serious Adverse Events, Deaths, and Discontinuation Due to Adverse Events From Day 1 to Week 48 - All Treated Population|Adverse events (AEs) and Serious AEs (SAEs) were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse events version 3.0. Week 48 database lock was 27 July 2010.|Day 1 to Week 48|Treated participants received at least one dose of a study drug.||participants|||Number
781798|NCT00796991|Secondary|Number of Participants With Objective Response to Treatment and Disease Control Using mWHO Criteria - All Randomized Participants|Number of participants with an objective response to treatment excluded participants with a best overall response (BOR) of Stable Disease (SD). Disease control is non-progression of disease while on treatment. A participant was considered to have achieved disease control if he/she had a BOR of CR, PR, or SD in the absence of resected index lesions or new lesions while the participant was considered to have an objective response to treatment in he/she had a BOR of CR or PR in the absence of resected index lesions or new lesions.|Day 1 to Week 48|Randomized Population includes all participants randomized to a treatment arm||participants|||Number
781799|NCT00796991|Secondary|Number of Participants in Best Overall Response Categories Based on Immune Related (ir) Response Criteria (RC) - All Treated Participants|Assessments: Weeks 12, 16, 20, and 24. Participants with resected index or new lesions considered progressed in their disease. The immune-related (ir) response criteria (irRC) represents further modifications of mWHO criteria reflecting clinical experience with ipilimumab in which objective and durable responses (as per mWHO) were observed in participants following progression and without intervening alternative anti-cancer therapy. Immune-related (ir)Complete Response (irCR): Complete disappearance of all index lesions; ir Partial Response (irPR): Decrease, relative to baseline, of 50% or greater in sum of products of the two largest perpendicular diameters of all index and all new measurable lesions, in the absence of irCR; ir Stable Disease (irSD): Does not meet criteria for irCR or irPR, in the absence of progressive disease (PD); ir PD: At least 25% increase in Tumor Burden compared to sum of product diameters (SPD) at nadir. ir Unknown=participants overall response not known.|Day 1 to Week 48|Treated participants received at least one dose of a study drug.||participants|||Number
781800|NCT00796991|Secondary|Number of Participants in Best Overall Response Categories Based on Modified World Health Organization (mWHO) Criteria - All Treated Participants|Assessments for antitumor activity by physical exam and routine anatomic imaging were at Week 12 and confirmatory imaging at Weeks 16, 20, and 24. Participants with resected index or new lesions were considered progressed in their disease. Complete Response (CR): Complete disappearance of all index lesions; Partial Response (PR): Decrease, relative to baseline, of 50% or greater in the sum of the products of the two largest perpendicular diameters of all index lesions, in the absence of Complete Response; Stable Disease (SD): Does not meet criteria for complete or partial response, in the absence of progressive disease. Participants with PR or CR that was not confirmed after at least 4 weeks are scored as SD unless they have new primary lesions; Progressive Disease: At least 25% increase in the sum of products of all index lesions and/or the appearance of any new lesion(s). Unknown=the participants overall response was not known.|Day 1 to Week 48|Treated participants received at least one dose of a study drug.||participants|||Number
781801|NCT00796991|Secondary|Pharmacokinetic Parameter Volume of Distribution at Steady State (Vss) for Ipilimumab, Paclitaxel, Dacarbazine and Active Metabolite AIC - Pharmacokinetic Analysis Population|Vss reported in liters(L): derived from drug concentration versus time for ipilimumab (Day 43 only) and paclitaxel, dacarbazine, and AIC (Days 1, 43). Ipilimumab determined from plasma ELISA; LLOQ=0.8 µg/mL; ULOQ=25.6 µg/mL; sample times on Day 43=0 hour (h) predose, 1.5, 4.0, 24, 72, 168, 336, 504 h post dose; starting Day 162 every 12 weeks (Day 1 and 22= 0 h). Paclitaxel determined from plasma using LC/MS/MS detection; LLOQ=10 nanograms per milliliter (ng/mL); ULOQ=5000 ng/mL; sample times Day 1 and Day 43=0 h predose, 1.5, 3.0, 3.5, 5,5, 9.5, 24, 48 h postdose. Dacarbazine (DTIC) and AIC determined from plasma using liquid chromatography API tandem mass spectrometry (LC-API/MS/MS) detection; LLOQ for dacarbazine=10.0 ng/mL; ULOQ=5000 ng/mL; AIC LLOQ=0.05 µg/mL; ULOQ=25.0 µg/mL; sample times Day 1: 0 h predose, 1, 1.5, 2.5, 3.5, 5.5, 9.5, 24 h post dose.|Day 1 (0 h) to Day 43|N=participants who received study drug and with adequate PK profiles. N is presented for each study drug in each category below. Day 43=ipilimumab+paclitaxel/carboplatin or Day 43=ipilimumab+dacarbazine.||L||Geometric Coefficient of Variation|Geometric Mean
781802|NCT00796991|Primary|Area Under the Concentration Time Curve (AUC) From Time Zero to 21 Days [AUC(0-21d)] for Ipilimumab and AUC Time Zero Extrapolated to Infinity [AUC(INF)] for Paclitaxel, Dacarbazine and the Active Metabolite AIC - Pharmacokinetic Analysis Population|AUC=micrograms*hour(h) per mL (µg*h/mL): derived from drug concentration versus time for ipilimumab (Day 43 only) and paclitaxel, dacarbazine, and AIC (Days 1, 43). Ipilimumab determined from plasma ELISA; LLOQ=0.8 µg/mL; ULOQ=25.6 µg/mL; sample times on Day 43=0 hour (h) predose, 1.5, 4.0, 24, 72, 168, 336, 504 h post dose; starting Day 162 every 12 weeks (Day 1 and 22= 0 h). Paclitaxel determined from plasma using LC/MS/MS detection; LLOQ=10 nanograms per milliliter (ng/mL); ULOQ=5000 ng/mL; sample times Day 1 and Day 43=0 h predose, 1.5, 3.0, 3.5, 5,5, 9.5, 24, 48 h postdose. Dacarbazine (DTIC) and AIC determined from plasma using liquid chromatography API tandem mass spectrometry (LC-API/MS/MS) detection; LLOQ for dacarbazine=10.0 ng/mL; ULOQ=5000 ng/mL; AIC LLOQ=0.05 µg/mL; ULOQ=25.0 µg/mL; sample times Day 1: 0 h predose, 1, 1.5, 2.5, 3.5, 5.5, 9.5, 24 h post dose.|Day 1 (0 h) to Day 43|N=participants who received study drug and with adequate PK profiles. N is presented for each study drug in each category below. Day 1=paclitaxel/carboplatin or Day 1=dacarbazine; Day 43=ipilimumab+paclitaxel/carboplatin or Day 43=ipilimumab+dacarbazine.||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
781803|NCT00796991|Secondary|Pharmacokinetic Parameter of Clearance (CLT) for Ipilimumab, Paclitaxel, Dacarbazine and Active Metabolite AIC - Pharmacokinetic Analysis Population|CLT reported in milliliters/hour (mL/h): derived from drug concentration versus time for ipilimumab (Day 43 only) and paclitaxel, dacarbazine, and AIC (Days 1, 43). Ipilimumab determined from plasma ELISA; LLOQ=0.8 µg/mL; ULOQ=25.6 µg/mL; sample times on Day 43=0 hour (h) predose, 1.5, 4.0, 24, 72, 168, 336, 504 h post dose; starting Day 162 every 12 weeks (Day 1 and 22= 0 h). Paclitaxel determined from plasma using LC/MS/MS detection; LLOQ=10 nanograms per milliliter (ng/mL); ULOQ=5000 ng/mL; sample times Day 1 and Day 43=0 h predose, 1.5, 3.0, 3.5, 5,5, 9.5, 24, 48 h postdose. Dacarbazine (DTIC) and AIC determined from plasma using liquid chromatography API tandem mass spectrometry (LC-API/MS/MS) detection; LLOQ for dacarbazine=10.0 ng/mL; ULOQ=5000 ng/mL; AIC LLOQ=0.05 µg/mL; ULOQ=25.0 µg/mL; sample times Day 1: 0 h predose, 1, 1.5, 2.5, 3.5, 5.5, 9.5, 24 h post dose..|Day 1 (0 h) to Day 43|N=participants who received study drug and with adequate PK profiles. N is presented for each study drug in each category below. Day 1=paclitaxel/carboplatin or Day 1=dacarbazine; Day 43=ipilimumab+paclitaxel/carboplatin or Day 43=ipilimumab+dacarbazine.||mL/h||Geometric Coefficient of Variation|Geometric Mean
781804|NCT00796991|Secondary|Pharmacokinetic Parameter of Terminal Elimination Half Life (T-HALF) for Ipilimumab, Paclitaxel, Dacarbazine and Active Metabolite AIC - Pharmacokinetic Analysis Population|T(HALF) reported in hours (h): derived from drug concentration versus time for ipilimumab (Day 43 only) and paclitaxel, dacarbazine, and AIC (Days 1, 43). Ipilimumab determined from plasma ELISA; LLOQ=0.8 µg/mL; ULOQ=25.6 µg/mL; sample times on Day 43=0 hour (h) predose, 1.5, 4.0, 24, 72, 168, 336, 504 h post dose; starting Day 162 every 12 weeks (Day 1 and 22= 0 h). Paclitaxel determined from plasma using LC/MS/MS detection; LLOQ=10 nanograms per milliliter (ng/mL); ULOQ=5000 ng/mL; sample times Day 1 and Day 43=0 h predose, 1.5, 3.0, 3.5, 5,5, 9.5, 24, 48 h postdose. Dacarbazine (DTIC) and AIC determined from plasma using liquid chromatography API tandem mass spectrometry (LC-API/MS/MS) detection; LLOQ for dacarbazine=10.0 ng/mL; ULOQ=5000 ng/mL; AIC LLOQ=0.05 µg/mL; ULOQ=25.0 µg/mL; sample times Day 1: 0 h predose, 1, 1.5, 2.5, 3.5, 5.5, 9.5, 24 h post dose.|Day 1 (0 h) to Day 43|N=participants who received study drug and with adequate PK profiles. N is presented for each study drug in each category below. Day 1=paclitaxel/carboplatin or Day 1=dacarbazine; Day 43=ipilimumab+paclitaxel/carboplatin or Day 43=ipilimumab+dacarbazine.||h||Standard Deviation|Mean
781805|NCT00796991|Secondary|Pharmacokinetic Parameter of Time of Maximum Observed Concentration (Tmax) for Ipilimumab, Paclitaxel, Dacarbazine and Active Metabolite AIC - Pharmacokinetic Analysis Population|Tmax reported in hours (h): derived from drug concentration versus time for ipilimumab (Day 43 only) and paclitaxel, dacarbazine, and AIC (Days 1, 43). Ipilimumab determined from plasma ELISA; LLOQ=0.8 µg/mL; ULOQ=25.6 µg/mL; sample times on Day 43=0 hour (h) predose, 1.5, 4.0, 24, 72, 168, 336, 504 h post dose; starting Day 162 every 12 weeks (Day 1 and 22= 0 h). Paclitaxel determined from plasma using LC/MS/MS detection; LLOQ=10 nanograms per milliliter (ng/mL); ULOQ=5000 ng/mL; sample times Day 1 and Day 43=0 h predose, 1.5, 3.0, 3.5, 5,5, 9.5, 24, 48 h postdose. Dacarbazine (DTIC) and AIC determined from plasma using liquid chromatography API tandem mass spectrometry (LC-API/MS/MS) detection; LLOQ for dacarbazine=10.0 ng/mL; ULOQ=5000 ng/mL; AIC LLOQ=0.05 µg/mL; ULOQ=25.0 µg/mL; sample times Day 1: 0 h predose, 1, 1.5, 2.5, 3.5, 5.5, 9.5, 24 h post dose..|Day 1 (0 h) to Day 43|N=participants who received study drug and with adequate PK profiles. N is presented for each study drug in each category below. Day 1=paclitaxel/carboplatin or Day 1=dacarbazine; Day 43=ipilimumab+paclitaxel/carboplatin or Day 43=ipilimumab+dacarbazine.||h||Full Range|Median
781826|NCT00797316|Primary|Change From Baseline to Week 8 in Mean Sitting Systolic Blood Pressure (msSBP)||Baseline and Week 8|Full analysis set||mm Hg||Standard Error|Least Squares Mean
781827|NCT00797459|Secondary|Wrinkle Improvement at Day 14|This measure was performed by the validated GAIS tool (Global Asthetic Improvement Scale). The GAIS was completed by the participant at day 14. The GAIS is a qualitative 5 point scale evaluating Aesthetic Improvement (0=worse, 1=no change, 2=Improved, 3=Much Improved, 4=very much improved). Treatment success is defined as at least a one grade improvement (2, 3, or 4) from pre-treatment.|14 days after treatment when compared to baseline|||participants|||Number
781806|NCT00796991|Primary|Pharmacokinetic Parameter Maximum Observed Serum Concentration (Cmax) for Ipilimumab, Paclitaxel, Dacarbazine and the Active Metabolite for Dacarbazine, 5-aminoimidazole-4carboxamide (AIC)- Pharmacokinetic Analysis Population|Cmax=micrograms per milliliter (µg/mL): drug concentration versus time for ipilimumab (Day 43) and paclitaxel, dacarbazine, and AIC (Days 1, 43). Ipilimumab determined from plasma by Enzyme-linked Immunosorbent Assay (ELISA); lower level of quantitation (LLOQ)=0.8 µg/mL; upper limit of quantitation (ULOQ)=25.6 µg/mL; Day 43=0 hour (h) predose, 1.5, 4.0, 24, 72, 168, 336, 504 h post dose; from Day 162 on every 12 weeks (Day 1 and 22= 0 h). Paclitaxel determined using liquid chromatography tandem mass spectrometry (LC/MS/MS) detection; LLOQ=10 nanograms per milliliter (ng/mL); ULOQ=5000 ng/mL; Day 1 and Day 43=0 h predose, 1.5, 3.0, 3.5, 5,5, 9.5, 24, 48 h postdose. Dacarbazine (DTIC) and AIC determined from plasma using liquid chromatography atmospheric pressure ionization (API) tandem mass spectrometry (LC-API/MS/MS) detection; LLOQ for dacarbazine=10.0 ng/mL; ULOQ=5000 ng/mL; AIC LLOQ=0.05 µg/mL; ULOQ=25.0 µg/mL; Day 1: 0 h predose, 1, 1.5, 2.5, 3.5, 5.5, 9.5, 24 h post dose.|Day 1 (0 h) to Day 43|N=participants who received study drug and with adequate Pharmacokinetic (PK) profiles. N is presented for each study drug in each category below. Day 1=paclitaxel/carboplatin or Day 1=dacarbazine; Day 43=ipilimumab+paclitaxel/carboplatin or Day 43=ipilimumab+dacarbazine.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
781807|NCT00797108|Other Pre-specified|Number of Participants With Healthcare Resource Utilization|Healthcare resource utilization was to be evaluated using the assessment of the following: date and duration of index admission, duration of hospitalization, date of discharge, location of discharge, type/length of treatment inside and outside of the hospital, healthcare professional visits outside of the hospital, emergency room visits, and other hospitalizations.|Baseline up to 15 to 28 days after EOT|This assessment was not performed due to the small sample size and hence data for this outcome measure is not reported.|||||
781808|NCT00797108|Other Pre-specified|Population Pharmacokinetics|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study.|0.5 to 1 hours, 1.5 to 3 hours, 3 to 5 hours after initiation of first intravenous dose; 0.5 to 2.5 hours, 4 to 6 hours following administration of oral dose on the day of IV to oral switch (minimum of 2 days equivalent on intravenous dose)||||||
781809|NCT00797108|Other Pre-specified|Number of Participants With Categorical Change From Baseline in Vital Signs|Participants who met the categorical criteria for increase in vital signs data were reported. Categorical criteria for increase from baseline vital signs data: supine and sitting systolic blood pressure (BP) of greater than or equal to (>=) 30 millimeter of mercury (mmHg); supine and sitting diastolic BP of >=20 mmHg.|Baseline up to 15 to 28 days after EOT|ITT population included all randomized participants who received at least 1 dose of double blind study drug. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies participants evaluable for this measure for specified category for each arm, respectively.||participants|||Number
781810|NCT00797108|Other Pre-specified|Number of Participants With Abnormal Physical Examination Findings|A physical examination included an examination of the general appearance, skin, heart, head, eyes, ears, nose, throat, breasts, abdomen, musculoskeletal, neck, neurological, extremities, and others. Criteria for abnormal physical findings were based on investigator’s discretion.|Last observation (up to 15-28 days after EOT, approximately 38 days)|ITT population included all randomized participants who received at least 1 dose of double blind study drug.||participants|||Number
781811|NCT00797108|Other Pre-specified|Number of Participants With Abnormal Laboratory Test Findings|Criteria for laboratory abnormalities: hemoglobin (Hb), hematocrit, red blood cell (RBC) (less than [<] 0.8*lower limit of normal [LLN]); reticulocyte (absolute and percentage) (<0.5*LLN or greater than [>] 1.5*upper LN [ULN]); platelet (<0.5*LLN or >1.75*ULN); white blood cell (WBC) (<0.6*LLN or >1.5*ULN); lymphocyte, neutrophil (<0.8*LLN or >1.2*ULN); eosinophil, monocyte, basophil (>1.2*ULN); bilirubin (BR) (>1.5*ULN); aspartate and alanine aminotransferase, gamma-glutamyl transpeptidase, alkaline phosphatase, lactate dehydrogenase (>3.0*ULN); total protein, albumin (<0.8*LLN or >1.2*ULN);blood urea nitrogen, creatinine (>1.3*ULN); sodium (<0.95*LLN or >1.05*ULN); potassium, chloride, calcium, magnesium, bicarbonate (<0.9*LLN or >1.1*ULN); glucose (<0.6*LLN or >1.5*ULN); urine (pH [<4.5 or >8], glucose, protein, blood, ketone [>=1]). Total number of participants with abnormal laboratory values were reported.|Baseline up to 15 to 28 days after EOT|ITT population included all randomized participants who received at least 1 dose of double blind study drug. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||participants|||Number
781812|NCT00797108|Other Pre-specified|Number of Participants Who Died||Baseline up to 15 to 28 days after EOT|ITT population included all randomized participants who received at least 1 dose of double blind study drug.||participants|||Number
781813|NCT00797108|Secondary|Change From Baseline in Community Acquired Pneumonia (CAP) Symptom Questionnaire at Test of Cure (TOC) and Follow-up Visit|The CAP Symptom Questionnaire was a participant reported questionnaire administered by interview. It consisted of 12 items (coughing, chest pains, shortness of breath, sweating, chills, headache, nausea, muscle pain, lack of appetite, trouble concentrating, trouble sleeping, and fatigue). Depending on if the participant had or not had symptoms/problems, they were asked how much they had been bothered by the symptoms/problems over the previous 24 hours. CAP items were rated on the 6-point response scale (0 = participant did not have symptom/problem: 1 = not at all, 2 = a little, 3 = moderately, 4 = quite a bit, 5 = extremely; if the participant had the symptom/problem and were bothered). All 12 items score were summed and averaged to produce a CAP symptom score (range, 0 to 6). High values indicated poorer outcomes (higher symptom bothersomeness).|Baseline, TOC (7 to 14 days after end of treatment), Follow-up (15 to 28 days after EOT)|Clinically evaluable population. Here ‘n’ signifies participants evaluable for this measure at specified time points for each arm, respectively.||units on a scale||Standard Deviation|Mean
781828|NCT00797459|Primary|Treatment Difference in Pain as Measured by a Visual Analogue Scale|No pain is noted at 0 mm and worst pain is noted at 100 mm.|After Injection on Day of Treatment|This is a split-face design. Restylane and Restylane with Lidocaine was injected to different sides of the subject's face. A total of 60 subjects received both products. The study evaluated which side of the face had less pain, as measured by the Visual Analogue Scale (VAS).||Scores on a VAS Scale|Participants|Standard Deviation|Mean
782084|NCT00810771|Secondary|Self Efficacy.|Outcome measure measuring self-efficacy using 5-item measure, dichotomized into low vs. high self-efficacy (confidence) in getting screened.|3-5 days after Decider Guider intervention.|Data was not collected for Usual Care arm.||percentage of participants|||Number
781814|NCT00797108|Secondary|Number of Participants With Microbiological Response at Test of Cure (TOC) Visit|Microbiological response assessed at participant level. Eradication=the absence of the original pathogens from the post-treatment TOC culture of specimen from the original site of infection. Presumed eradication=the complete resolution of signs and symptoms associated with cessation of culturable specimen (for example, sputum). Persistence=the presence of the original pathogen in the post-treatment TOC culture specimen from the original site of infection. Presumed persistence=in a participant who was judged to be a clinical failure and a culture of specimen was not possible or was not done, it was presumed that there was persistence of the pathogen. Not applicable microbiologic response included participants that did not have post-treatment microbiologic cultures due to early discontinuation. Data reported for eradication is combination of eradication and presumed eradication data and data reported for persistence is combination of persistence and presumed persistence data.|7 to 14 days after EOT|Microbiologic clinically evaluable population included all microbiologic ITT participants (all ITT participants in whom a pathogen was isolated at baseline) who also met criteria for the clinically evaluable subset.||participants|||Number
781815|NCT00797108|Secondary|Percentage of Participants With Clinical Response at End of Treatment (EOT) and Follow-up Visit|CR was based primarily on global assessment of clinical presentation of participant made by investigator at evaluation time point. At EOT (Day 7 to 10) and follow-up (15 to 28 days after EOT), CR was evaluated as “cure”=resolution of clinical signs and symptoms related to the acute infection, or clinical improvement in which no additional antibiotics were deemed necessary when compared to baseline; “failure”=persistence or progression of baseline signs and symptoms of pneumonia, development of new pulmonary or extrapulmonary clinical findings consistent with active infection and those participants that were not assessed for clinical response due to early discontinuation; with additional CR evaluated as “improvement”= of few not all signs and symptoms of pneumonia when compared to baseline and no additional antibacterial treatment required at EOT and “indeterminate”=extenuating circumstances precluded classification to 1 of the above at follow-up.|EOT (Day 7 to 10) , Follow-up (15 to 28 days after EOT)|Clinically evaluable: all ITT participants who received at least 80% of study drug, no concomitant systemic antibiotic with activity against relevant pathogens, diagnosed with pneumonia as defined by protocol inclusion criteria, assignment of pneumonia severity index (PSI) score III (low: score range 71-90)-IV(high: score range 91-130).||percentage of participants|||Number
781816|NCT00797108|Primary|Percentage of Participants With Clinical Response at Test of Cure (TOC) Visit|Clinical response (CR) was based primarily on global assessment of clinical presentation of participant made by investigator at evaluation time point. At TOC (7 to 14 days after end of treatment [EOT]) CR was evaluated as “cure”=resolution of clinical signs and symptoms related to the acute infection, or clinical improvement in which no additional antibiotics were deemed necessary when compared to baseline; “failure”=persistence or progression of baseline signs and symptoms of pneumonia (for example: body temperature, white blood cell [WBC] count, respiratory rate, auscultatory findings, cough, sputum production), development of new pulmonary or extrapulmonary clinical findings consistent with active infection and those participants that were not assessed for clinical response due to early discontinuation; “indeterminate”=extenuating circumstances precluded classification to 1 of the above.|7 to 14 days after end of treatment|Clinically evaluable: all ITT participants who received at least 80% of study drug, no concomitant systemic antibiotic with activity against relevant pathogens, diagnosed with pneumonia as defined by protocol inclusion criteria, assignment of pneumonia severity index (PSI) score III (low: score range 71-90)-IV(high: score range 91-130).||percentage of participants|||Number
781817|NCT00797212|Secondary|Percentage of Participant Ratings for Overall Testing Experience With This Meter|Subjects completed a questionnaire rating their overall experience with the Apollo Blood Glucose Monitor System (User feedback on the system). The rating scale was 0 (Unacceptable) to 4 (Excellent).|One hour|per protocol||percent of participants|||Number
781818|NCT00797212|Secondary|Percentage of Participants Rated as <=3 (Labeling Comprehension)|"Study staff rated participants as to their success at performing meter testing. The rating scale was:
Successful
Successful after being referred to user instructions
Successful with verbal assistance or review of part of user instructions (Similar to review of a specific function during a Customer Service call.)
Unsuccessful (Incorrectly performed part of the testing regimen or required intervention by study staff.)"|One hour|per protocol||percent of participants|||Number
781819|NCT00797212|Primary|Number of AST Results Within +/- 15mg/dL or +/- 20% of Fingerstick (FS)Blood Glucose Results|Performance of the blood glucose monitoring system when the system is used for alternative site testing (AST) with samples from the palm and forearm compared with BGMS fingerstick capillary blood results obtained by an HCP|One hour|per protocol||number of AST Blood Glucose Results|||Number
781820|NCT00797277|Secondary|Change of the Agitation-Calmness Evaluation Scale (ACES) Score From Baseline to 120 Minutes After 1st Injection|Agitation was further assessed by the Agitation Calmness Evaluation Scale (ACES) (Copyright 1998, Eli Lilly and Company), a single-item scale developed by Eli Lilly and Company on which 1 indicates marked agitation; 2, moderate agitation; 3, mild agitation; 4, normal; 5, mild calmness; 6, moderate calmness; 7, marked calmness; 8, deep sleep; and 9, unable to be aroused.|from baseline to 120 minutes after first injection|Those receiving at least one IM injection||units on a scale||Standard Deviation|Mean
781821|NCT00797277|Primary|The Change of the Positive and Negative Symptom Scale Excited Component (PANSS-EC) Score From Baseline to 120 Minutes After First Injection|The primary efficacy measure was PANSS-EC, which was derived from the PANSS by its originators using a principal-components factor analysis, and includes the items of tension, uncooperativeness, hostility, poor impulse control and excitement.22 The score of each item ranges from 1 (normal) to 7 (most severe), with a total sum score ranging from 5 to 35. The changes in PANSS-EC from baseline to 2 hours after the first injection were compared.|from baseline to 120 minutes after first injection|Those receiving at least one IM injection||units on a scale||Standard Deviation|Mean
781822|NCT00797316|Secondary|Change From Baseline to Week 8 in Pulse Pressure||Baseline and Week 8|Full analysis set||mm Hg||Standard Error|Least Squares Mean
781823|NCT00797316|Secondary|Percentage of Patients Achieving Blood Pressure Control at Week 8|Blood pressure control is defined as a patient who achieves a target Blood Pressure of mean sitting Systolic Blood Pressure / mean sitting Diastolic Blood pressure < 140/90 mmHg.|8 weeks|Full analysis set||Percentage of Participants|||Number
781842|NCT00799292|Secondary|Operative Time and Complication Rates||Duration of procedures and immediate post-operative stay in hospital||||||
781829|NCT00797511|Secondary|Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL Polio Vaccine|Solicited Injection Site Reactions: Pain, Erythema/redness, Swelling, and Extensive swelling of vaccinated limb. Solicited Systemic Reactions: Fever (temperature ≥ 37.5ºC), Headache, Malaise, and Myalgia.|Day 0 up to Day 7 post-vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.||Participants|||Number
781830|NCT00797511|Primary|Geometric Mean Titers of Antibodies to Pertussis Antigens Following Vaccination With ADACEL Polio|Pre- and post-vaccination GMTs for the Pertussis toxoid (PT), Pertussis filamentous hemagglutinin (FHA), Pertussis pertactin (PRN), and Pertussis Fimbriae types 2 and 3 (FIM), all determined by enzyme-linked immunosorbent assay (ELISA).|Day 0 (pre-vaccination) and Day 28 post-vaccination|Geometric mean titers to the vaccine Pertussis antigens were assessed in the per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
781831|NCT00797511|Primary|Geometric Mean Titers (GMTs) of Antibodies to ADACEL Polio Vaccine Antigens Following Vaccination|Diphtheria antibody concentrations determined by diphtheria toxin neutralization assay; Tetanus antibody concentrations determined by enzyme-linked immunosorbent assay (ELISA).|Day 28 post-vaccination|Geometric mean titers were assessed in the per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
781832|NCT00797511|Primary|Number of Participants With Booster Response to Vaccine Pertussis Antigens Following Vaccination With ADACEL Polio (TdcP-IPV) Vaccine.|The anti-Pertussis concentration were determined by ELISA. The criteria for demonstrating booster response are: (i) Pre-vaccination antibody concentrations less than the lower limit of quantitation (LLOQ) for each anti-pertussis antibody (PT, FHA, FIM, and PRN) but a post-vaccination levels ≥ 4 x LLOQ; or (ii) Pre-vaccination antibody concentrations ≥ LLOQ but < 4 x LLOQ with a 4-fold rise rate; or (iii) Pre-vaccination antibody concentrations ≥ 4 x LLOQ but with a 2-fold rise rate.|Day 28 post-vaccination|Anti-Pertussis concentrations were assessed in the per-protocol population.||Participants|||Number
781833|NCT00797511|Primary|Number of Participants With Seroprotection to Vaccine Antigens Following Vaccination With ADACEL Polio (TdcP-IPV) Vaccine.|"Diphtheria concentrations determined by diphtheria toxin neutralization assay (Dip SN); Tetanus concentrations determined by enzyme-linked immunosorbent assay (ELISA).
Seroprotection titer levels were defined as: Anti-diphtheria antibody titers ≥0.1 international unit (IU) per milliliter (mL); Anti-tetanus antibody titers ≥0.01 IU/mL and ≥0.1 IU/mL; Anti-Polio (≥ 8 1/dilution)."|Day 28 post-vaccination|Anti-tetanus and anti-diphtheria concentrations were assessed in the per-protocol population.||Participants|||Number
781834|NCT00797563|Secondary|Number of Partipants Who Gave These Ratings for Overall Testing Experience With This Meter|Subjects completed a questionnaire rating their overall experience with the Apollo Blood Glucose Monitoring System (User feedback on the system). The rating scale was 0 (Unacceptable) to 4 (Excellent).|One hour|||number of participants|||Number
781835|NCT00797563|Secondary|Percentage of Participants Rated as <=3 (Labeling Comprehension)|"Study staff rated participants on their success at performing BG testing and Autolog feature after reading product labeling. The rating scale was:
Successful
Successful after being referred to user instructions
Successful with verbal assistance or review of part of user instructions (Similar to review of a specific function during a Customer Service call.)
Unsuccessful (Incorrectly performed part of the testing regimen or required intervention by study staff.)"|One hour|per protocol||percent of participants|||Number
781836|NCT00797563|Primary|Number of Capillary and Venous Results Within +/- 15mg/dL or +/- 20% of Laboratory Glucose Method|Subjects with diabetes and healthcare professionals (HCPs) used a new blood glucose monitoring system (BGMS) with subject capillary blood. HCPs used the new bgms with subject venous blood. All results were compared to a lab glucose method. The BGMS has programmed algorithms to provide results equivalent to either serum/plasma or whole blood glucose methods. Number of results were obtained by combining results from three lots of Contour Blood Glucose strips.|One hour|"One subject had a non-serious, non-device related anticipated adverse event (a low blood glucose concentration). The subject was treated and discontinued the study.
The tube collected for the capillary lab glucose assay from one subject was lost in processing, so 100 capillary and 101 venous samples were compared with the lab method."||number of blood glucose (BG) results|||Number
781837|NCT00799227|Secondary|Percentage of Patients With Fluorescein Leakage as Measured by Fluorescein Angiography (FA) in the Study Eye|Fluorescein leakage is measured in the study eye by FA. FA is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. The assessment of fluorescein leakage compared to baseline is categorized as Improved (leakage area decreased ≥ 10%), Unchanged (leakage area changed < 10%), and Worsened (leakage area increased ≥ 10%).|Baseline, Week 26|Intent to Treat: all enrolled patients||Percentage of Patients|||Number
781838|NCT00799227|Secondary|Percentage of Patients With at Least 10 Letters of Improvement in BCVA From Baseline in the Study Eye|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.|Baseline, Week 26|Intent to treat: all enrolled patients||Percentage of Patients|||Number
781839|NCT00799227|Secondary|Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase from baseline in the number of letters read correctly indicates improvement and a decrease from baseline in the number of letters read correctly indicates a worsening.|Baseline, Week 26|Intent to Treat: all enrolled patients||Letters Read Correctly||Standard Deviation|Mean
781840|NCT00799227|Primary|Change From Baseline in Central Retinal Thickness in the Study Eye|Central retinal thickness is assessed in the study eye by Optical Coherence Tomography (OCT). OCT is a laser-based, noninvasive, diagnostic system that provides high-resolution, three-dimensional images of the retina from which retinal thickness can be measured. A negative change from baseline in retinal thickness indicates an improvement and a positive change from baseline indicates a worsening.|Baseline, Week 26|Intent to Treat: all enrolled patients||Microns||Standard Deviation|Mean
781841|NCT00799292|Primary|Estimated Blood Loss|Estimated blood loss as mL|Duration of vaginal hysterectomy|||mL||Standard Deviation|Mean
781846|NCT00799409|Secondary|Hour 8.75 Packet Activity Decode the Mystery Sentence|Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).|Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.||Units on a scale||Standard Deviation|Mean
781847|NCT00799409|Secondary|Hour 8.75 Packet Activity Word Search|Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).|Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.||Units on a scale||Standard Deviation|Mean
781848|NCT00799409|Secondary|Hour 8.75 Packet Activity Complete Sentences Using Words Provided|Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).|Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.||Units on a scale||Standard Deviation|Mean
781849|NCT00799409|Secondary|Hour 8.75 Packet Activity Identify Multiple Meanings for Words|Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).|Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.||Units on a scale||Standard Deviation|Mean
781850|NCT00799409|Secondary|Hour 8.75 Packet Activity Alphabetize List of Words|Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).|Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.||Units on a scale||Standard Deviation|Mean
781851|NCT00799409|Secondary|Hour 8.75 Packet Activity Identify Root Word|Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).|Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.||Units on a scale||Standard Deviation|Mean
781852|NCT00799409|Secondary|Hour 8.75 Packet Activity Short Story With Questions for Comprehension|Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).|Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.||Units on a scale||Standard Deviation|Mean
781853|NCT00799409|Secondary|Hour 3.0 Grammar Task|This task, presented once during a laboratory school day, was designed to index “attention to detail” by determining how many grammatical mistakes each child could identify and circle in a brief paragraph. The errors were not difficult to identify and were designed to show attention to task, not comprehension. A higher number of errors identified, of those possible, was indicative of better attention - identification of grammatical errors(range: 0, 1 represents correct responses divided by the number of possible responses).|Hour 3.0 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.||Units on a scale||Standard Deviation|Mean
781854|NCT00799409|Secondary|Hour 5.5 Test of Variables of Attention (TOVA) Omissions Standard Score|The TOVA (range: unbounded) is a computerized, visual continuous performance test providing a measure of attention. The stimulus, presented for 100 milliseconds (ms) at the rate of 30 per minute, is a computer-presented square containing a square hole near the top (target) or bottom (non-target) edge. Higher scores indicated better performance, lower scores indicate worse performance. Clinical interpretation: scores below 80 are considered abnormal, 80-85 are considered borderline, and scores above 85 are considered within normal limits.|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.||Units on a scale||Standard Deviation|Mean
781905|NCT00799591|Secondary|Percentage of Participants With Microbiological Sampling Results During Treatment Phase With Tigecycline: Direct Examination|Microbiological sampling results categorized according to direct examination (identification of the class of germs).|Post-baseline (Day 1) through last dose of study treatment or up to 25 months|ITT population. N=number of participants with analyzable data at observation; participants may be represented in >1 category.||percentage of participants|||Number
781855|NCT00799409|Secondary|Hour 5.5 Wechsler Intelligence Scale for Children - 3rd ed. (WISC-III-PI) Digit Span Forwards|Each child individually was given a sequence of numbers with the sequence becoming progressively longer. The child was then asked to repeat the digits in the same sequence, either forwards or backwards. Each sequence length was attempted twice. The test was complete after failure on both trials of any sequence length. One point was awarded if the participant passed only 1 trial of a sequence length. Zero points were given if the participant failed both trials. The maximum raw scores were 16 forwards and 14 backwards. A higher score was indicative of better recall and attention (range: 0, 16).|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.||Correct Trials||Standard Deviation|Mean
781856|NCT00799409|Secondary|Hour 3.5 Dynamic Indicators of Basic Early Literacy Skills (DIBELS)|The DIBELS (range: 0, 376), used to assess reading fluency, consists of standardized, individually administered measures of early literacy development. These short (1 minute) fluency measures were developed based upon essential early literacy domains to assess development of phonological awareness, alphabetic understanding, and automaticity and fluency. Only the paragraph fluency component of an age/grade-appropriate DIBELS was used. A higher score indicated better performance, as it represented that the subject orally read a greater number of words correctly within the time allowed.|Hour 3.5 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.||Units on a scale||Standard Deviation|Mean
781857|NCT00799409|Secondary|Hour 7.5 Test of Handwriting Skills (Revised) (THS-R) Standard Score|The THS-R (range: unbounded) is a standardized, untimed assessment designed to evaluate neurosensory integration manifested in manuscript and cursive writing. The test includes subtests: writing from memory or dictation the letters of the alphabet in order, single digit-numbers out of order, selected words, and copying selected letters, words, and sentences. Each subtest was scored from zero (poorly formed letters) to 3 (perfectly formed letters). 100 is the normal mean; scores lower than 100 indicate performance worse than normal, scores above 100 indicate performance better than normal.|Hour 7.5 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.||Units on a scale||Standard Deviation|Mean
781858|NCT00799409|Secondary|Hour 8.75 Gray Silent Reading Test (GSRT) Reading Quotient|Gray Silent Reading Test (GSRT)Reading Quotient is a reliable, validated measure of reading comprehension administered in the group setting during the first half hour of the homework session (range: 0,unbounded). A higher score is preferable as it means more questions were answered correctly.|Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.||Units on a scale||Standard Deviation|Mean
781859|NCT00799409|Secondary|Hour 5.5 Wechsler Intelligence Scale for Children - 3rd ed. (WISC-III-PI) Digit Span Backwards|Each child individually was given a sequence of numbers with the sequence becoming progressively longer. The child was then asked to repeat the digits in the same sequence, either forwards or backwards. Each sequence length was attempted twice. The test was complete after failure on both trials of any sequence length. One point was awarded if the participant passed only 1 trial of a sequence length. Zero points were given if the participant failed both trials. The maximum raw scores were 16 forwards and 14 backwards. A higher score was indicative of better recall and attention (range: 0, 14).|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.||Correct Trials||Standard Deviation|Mean
781860|NCT00799409|Secondary|Hour 5.5 Test of Variables of Attention (TOVA) Commissions Standard Score|The TOVA (range: unbounded) is a computerized, visual continuous performance test providing a measure of attention. The stimulus, presented for 100 milliseconds (ms) at the rate of 30 per minute, is a computer-presented square containing a square hole near the top (target) or bottom (non-target) edge. Higher scores indicated better performance, lower scores indicate worse performance. Clinical interpretation: scores below 80 are considered abnormal, 80-85 are considered borderline, and scores above 85 are considered within normal limits.|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.||Units on a scale||Standard Deviation|Mean
781861|NCT00799409|Secondary|Hour 5.5 Wide Range Assessment of Memory and Learning (WRAML-2) Finger Windows Forwards|WRAML-2 (range: 0, 28) is designed to evaluate a child's ability to learn and to memorize information, consists of 9 subtests from which 4 summary indexes can be calculated: verbal memory index, visual memory index, learning index, and general memory index. During this test the investigator pointed to a longer and longer series of windows on a card at the rate of 1 location per second, and then the child was asked to reproduce the sequence exactly. One point was given for each correctly recalled sequence, and the test was discontinued after 3 consecutive errors.|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.||Correct Sequences||Standard Deviation|Mean
781862|NCT00799409|Secondary|Hour 5.5 Wide Range Assessment of Memory and Learning (WRAML-2) Finger Windows Backwards|WRAML-2 (range: 0, 28) is designed to evaluate a child’s ability to learn and to memorize information, consists of 9 subtests from which 4 summary indexes can be calculated: verbal memory index, visual memory index, learning index, and general memory index. During this test the investigator pointed to a longer and longer series of windows on a card at the rate of 1 location per second, and then the child was asked to reproduce the sequence exactly in reverse order. One point was given for each correctly recalled sequence, and the test was discontinued after 3 consecutive errors.|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.||Correct Sequences||Standard Deviation|Mean
781863|NCT00799409|Secondary|Hour 5.5 Test of Variables of Attention (TOVA) Reaction Time Variability Standard Score|The TOVA (range: unbounded) is a computerized, visual continuous performance test providing a measure of attention. The stimulus, presented for 100 milliseconds (ms) at the rate of 30 per minute, is a computer-presented square containing a square hole near the top (target) or bottom (non-target) edge. Higher scores indicated better performance, lower scores indicate worse performance. Clinical interpretation: scores below 80 are considered abnormal, 80-85 are considered borderline, and scores above 85 are considered within normal limits.|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.||Units on a scale||Standard Deviation|Mean
781864|NCT00799409|Secondary|Hour 5.5 Test of Variables of Attention (TOVA) Reaction Time Standard Score|The TOVA (range: unbounded) is a computerized, visual continuous performance test providing a measure of attention. The stimulus, presented for 100 milliseconds (ms) at the rate of 30 per minute, is a computer-presented square containing a square hole near the top (target) or bottom (non-target) edge. Higher scores indicated better performance, lower scores indicate worse performance. Clinical interpretation: scores below 80 are considered abnormal, 80-85 are considered borderline, and scores above 85 are considered within normal limits.|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.||Units on a scale||Standard Deviation|Mean
781865|NCT00799409|Secondary|Hour 5.5 Test of Variables of Attention (TOVA) ADHD Composite Cutoff Score|The TOVA (range: unbounded) is a computerized, visual continuous performance test providing a measure of attention. The stimulus, presented for 100 milliseconds (ms) at the rate of 30 per minute, is a computer-presented square containing a square hole near the top (target) or bottom (non-target) edge. Higher scores indicate better performance, lower scores indicate worse performance. Clinical interpretation: an ADHD scores of -1.80 or lower (<= -1.80) are considered not within normal limits scores above -1.80 (> -1.80) are considered inconclusive (meaning, neither like-ADHD nor like-normal).|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.||Units on a scale||Standard Deviation|Mean
781866|NCT00799409|Secondary|Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Composite (SKAMP-Composite)|The SKAMP scale measures the manifestations of ADHD using an independent observer (teacher) rating of the child's impairment in classroom behavior. A composite score (range: 0, 78) for the SKAMP variable (13 items total) was obtained by summing the SKAMP-D and SKAMP-A subscale scores. A lower score was preferable, as a higher score represented greater behavioral impairment.|Hour 4 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.||Units on a scale||Standard Deviation|Mean
781867|NCT00799409|Secondary|Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Attention (SKAMP-Attention)|The SKAMP scale measures the manifestations of ADHD using an independent observer (teacher) rating of the child's impairment in classroom behavior. The SKAMP-Attention (SKAMP-A) (range: 0, 42) is a sum of the ratings on 7 attention items (getting started, sticking with tasks, attending to an activity, making activity transitions, completing assigned tasks, performing work accurately, and being neat and careful while writing or drawing). Each item was rated on a 7-point impairment scale (0=normal, 6=maximum impairment), with higher scores indicating more severe symptoms.|Hour 4 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.||Units on a scale||Standard Deviation|Mean
781868|NCT00799409|Secondary|Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Deportment (SKAMP-Deportment)|The SKAMP scale measures the manifestations of ADHD using an independent observer (teacher) rating of the child's impairment in classroom behavior. The SKAMP-Deportment (SKAMP-D) (range: 0, 36) is a sum of ratings on 6 deportment items (interacting with other children, interacting with adults, remaining quiet, staying seated, complying with the teacher’s directions, and following the classroom rules). Each item was rated on a 7-point impairment scale (0=normal, 6=maximum impairment), with higher scores indicating more severe symptoms.|Hour 4 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.||Units on a scale||Standard Deviation|Mean
781869|NCT00799409|Primary|Hour 4 Permanent Product Math Test Correct Score (PERMP-Correct)|PERMP (range: 0, 400) is a measure of academic productivity in children up to 14 years of age. These seatwork math tasks provide an objective measure of attention and accuracy in calculations. The level of difficulty is established on a screening math pretest performed at Visit 2. The subsequent laboratory school day assessments employed a series of 10-minute math tests (5 pages of 80 math problem each for a total of 400 problems available). Children were graded on the number of correct problems. A higher number of problems correct, of those attempted, was indicative of greater accuracy.|Hour 4 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.||Problems correct||Standard Deviation|Mean
781870|NCT00799409|Primary|Hour 4 Permanent Product Math Test Attempted Score (PERMP-Attempted)|PERMP (range: 0, 400) is a measure of academic productivity in children up to 14 years of age. These seatwork math tasks provide an objective measure of attention and accuracy in calculations. The level of difficulty is established on a screening math pretest. The subsequent laboratory school day assessments employed a series of 10-minute math tests (5 pages of 80 math problem each for a total of 400 problems available). Children were graded on the number of attempted problems. A higher number of problems attempted was indicative of greater attention to detail (higher score is preferable)|Hour 4 of the of the Lab School Day during Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point. Intent-to-Treat for Placebo and Concerta columns in the primary and secondary results are comprised of the 36 children randomized to Placebo/CONCERTA (lab day 1/lab day 2) plus the 35 children randomized to CONCERTA/Placebo||Problems attempted||Standard Deviation|Mean
781871|NCT00799422|Secondary|Mean Change From Dispense (Day 0) in Lens Diameter at 1 Week|Lens diameter at dispense was as listed on product label: 14.0 mm. Lens diameter at 1 week was as measured after lens removal. A positive number indicated a widening of lens diameter.|Dispense (Day 0), 1 week|This reporting group includes all participants who completed all study visits.||mm||Standard Deviation|Mean
781872|NCT00799422|Secondary|Mean Change From Dispense (Day 0) in Lens Base Curve at 1 Week|Lens base curve at dispense was as listed on product label: 8.4 millimeters (mm). Lens base curve at 1 week was as measured after lens removal. A negative number represented a steepening of the base curve.|Dispense (Day 0), 1 week|This reporting group includes all participants who completed all study visits.||mm||Standard Deviation|Mean
781906|NCT00799591|Secondary|Percentage of Participants With Microbiological Sampling Results During Treatment Phase With Tigecycline: Positive Blood Culture|Microbiological sampling results categorized as a positive blood culture (presence of infection).|Post-baseline (Day 1) through last dose of study treatment or up to 25 months|ITT population. N=number of participants with analyzable data at observation.||percentage of participants|||Number
781873|NCT00799422|Primary|Mean Circumlimbal Conjunctival Staining Score|Circumlimbal conjunctival staining was expressed as the sum of the individual scores observed across all of the evaluated regions of the eye. The bulbar conjunctiva was assessed by the investigator utilizing a slit-lamp and lissamine green ophthalmic dye. Staining coverage was scored separately in each of four regions (nasal, temporal, inferior, and superior) using a 4-point clinical grading scale (grade 0-3), where Grade 0 = No staining present; Grade 1 = Slight staining present; Grade 2 = Moderate staining present; and Grade 3 = Dense staining present. The scores for the four regions were summed, with a sum score range of 0-12. A lower score represents a more desirable outcome.|1 week|This reporting group includes all participants who completed all study visits.||Units on a scale||Standard Deviation|Mean
781874|NCT00799435|Secondary|Changes in Left Ventricular Diastolic Stiffness, Serum Levels of Advanced Glycation End Products, Serum Biomarkers of Collagen Synthesis, and Serum Levels of Brain Natriuretic Peptide||Measured at Week 12||||||
781875|NCT00799435|Primary|Change in Aortic Stiffness, as Measured by the Change in the Mean Aortic Pulse Wave Velocity||Measured at Week 12||||||
781876|NCT00799474|Secondary|Knowledge of HPV|Assessed participants' knowledge of HPV by summing correct responses to nine HPV knowledge items. Questions addressed what diseases are associated with HPV, how HPV is transmitted, and how common HPV infection is. For each item, participants were classified as having answered the item correctly or incorrectly.|At time of interview|HPV knowledge items were only asked to those men who had heard of HPV prior to survey (n=430)||Correct Responses||Standard Deviation|Mean
781877|NCT00799474|Secondary|Awareness of HPV Vaccine|"Measured if participants had heard of HPV vaccine prior to survey. Participants were asked if they had heard to HPV vaccine prior to the survey and had response options of yes, no, and I don't know."|At time of interview|||Participants|||Number
781878|NCT00799474|Primary|Willingness to Receive the Human Papillomavirus (HPV) Vaccine|"Measured participants' willingness to receive HPV vaccine. Participants were asked how willing they would be to get HPV vaccine if it were approved for use in males. A 5-point scale ranging from definitely not willing to definitely willing was used to meausure willingness."|at time of interview|One man reported having received human papillomavirus (HPV) vaccine so he was not asked willingness items which made the analytic sample size n=608||Participants|||Number
781879|NCT00799487|Secondary|Hour 8.75 Packet Activity - Decode the Mystery Sentence|Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).|Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.||Units on a scale||Standard Deviation|Mean
781880|NCT00799487|Secondary|Hour 8.75 Packet Activity - Word Search|Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).|Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.||Units on a scale||Standard Deviation|Mean
781881|NCT00799487|Secondary|Hour 8.75 Packet Activity - Complete Sentences Using Words Provided|Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).|Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.||Units on a scale||Standard Deviation|Mean
781882|NCT00799487|Secondary|Hour 8.75 Packet Activity - Identify Multiple Meanings for Words|Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).|Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.||Units on a scale||Standard Deviation|Mean
781907|NCT00799591|Secondary|Percentage of Participants (> 10%) With Use of Other Antibiotics in Combination With Tigecycline Who Had Clinical Success at Follow-up Visit|Combinations of antibiotic treatments for participants treated with clinical success with tigecycline. Clinical success defined as lack of need to use new antibiotic or a surgical treatment not initially planned for initial infection.|Baseline (Inclusion), Follow-up Visit (7 days after last dose or at hospital discharge whichever occurred within 7 days after last dose) or up to 25 months|ITT population; N=number of participants treated with combinations of antibiotics with analyzable data at observation.||percentage of participants|||Number
781883|NCT00799487|Secondary|Hour 8.75 Packet Activity - Alphabetize List of Words|Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).|Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.||Units on a scale||Standard Deviation|Mean
781884|NCT00799487|Secondary|Hour 8.75 Packet Activity - Identiy Root Word|Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).|Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.||Units on a scale||Standard Deviation|Mean
781885|NCT00799487|Secondary|Hour 8.75 Packet Activity - Short Story With Questions for Comprehension|Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order)(range: 0, 1 represents correct responses divided by the number of possible responses).|Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.||Units on a scale||Standard Deviation|Mean
781886|NCT00799487|Secondary|Hour 3.0 Grammar Task|This task, presented once during a laboratory school day, was designed to index “attention to detail” by determining how many grammatical mistakes each child could identify and circle in a brief paragraph. The errors were not difficult to identify and were designed to show attention to task, not comprehension. A higher number of errors identified, of those possible, was indicative of better attention - identification of grammatical errors (range: 0, 1 represents correct responses divided by the number of possible responses).|Hour 3.0 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.||Units on a scale||Standard Deviation|Mean
781887|NCT00799487|Secondary|Hour 5.5 Test of Variables of Attention (TOVA) Omissions|The TOVA is a computerized, visual continuous performance test which provides measures of attention. The stimulus, presented for 100 milliseconds (ms) at the rate of 30 per minute, is a computer-presented square containing a square hole near the top (target) or bottom (non-target) edge. The first half of the TOVA requires that the child sustain attention while the second half requires inhibition of response to a non-target. Number of targets missed. Higher score is preferable (observed range: -419.4, 108.9).|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.||Targets missed||Standard Deviation|Mean
781888|NCT00799487|Secondary|Hour 5.5 Wechsler Intelligence Scale for Children - 3rd ed. (WISC-III-PI) Digit Span Forwards|Each child individually was given a sequence of numbers with the sequence becoming progressively longer. The child was then asked to repeat the digits in the same sequence, either forwards or backwards. Each sequence length was attempted twice. The test was complete after failure on both trials of any sequence length. One point was awarded if the participant passed only 1 trial of a sequence length. Zero points were given if the participant failed both trials. The maximum raw scores were 16 forwards and 14 backwards. A higher score was indicative of better recall and attention (range: 0, 16).|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.||Correct Sequences||Standard Deviation|Mean
781889|NCT00799487|Secondary|Hour 3.5 Dynamic Indicators of Basic Early Literacy Skills (DIBELS)|The DIBELS (observed range: 0, 212), used to assess reading fluency, consists of standardized, individually administered measures of early literacy development. These short (1 minute) fluency measures were developed based upon essential early literacy domains to assess development of phonological awareness, alphabetic understanding, and automaticity and fluency. Only the paragraph fluency component of an age/grade-appropriate DIBELS was used. Children read 3 stories and completed the forms. A higher score was preferable and indicated a greater number of words read correctly in the time allowed|Hour 3.5 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.||Units on a scale||Standard Deviation|Mean
781890|NCT00799487|Secondary|Hour 7.5 Test of Handwriting Skills (Revised) (THS-R)|The THS-R is a standardized, untimed assessment designed to evaluate neurosensory integration manifested in manuscript and cursive writing. The test includes the 10 subtests: writing from memory the upper- and lower-case letters of the alphabet in order, writing from dictation the upper and lower-case letters of the alphabet out of order, single digit-numbers out of order, selected words, and copying selected letters, words, and sentences. Each subtest was scored from zero (poorly formed letters) to 3 (perfectly formed letters). A higher score was preferable (observed range: 0, 118).|Hour 7.5 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.||Units on a scale||Standard Deviation|Mean
781891|NCT00799487|Secondary|Hour 8.75 Gray Silent Reading Test (GSRT)|Gray Silent Reading Test (GSRT) is a reliable, validated measure of reading comprehension administered in the group setting during the first half hour of the homework session (observed range: 0, 141). A higher score is preferable as it means more questions were answered correctly.|Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.||Units on a scale||Standard Deviation|Mean
781892|NCT00799487|Secondary|Hour 5.5 Wechsler Intelligence Scale for Children - 3rd ed. (WISC-III-PI) Digit Span Backwards|Each child individually was given a sequence of numbers with the sequence becoming progressively longer. The child was then asked to repeat the digits in the same sequence, either forwards or backwards. Each sequence length was attempted twice. The test was complete after failure on both trials of any sequence length. One point was awarded if the participant passed only 1 trial of a sequence length. Zero points were given if the participant failed both trials. The maximum raw scores were 16 forwards and 14 backwards. A higher score was indicative of better recall and attention (range: 0, 14).|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.||Correct Sequences||Standard Deviation|Mean
781893|NCT00799487|Secondary|Hour 5.5 Test of Variables of Attention (TOVA) Commissions|The TOVA is a computerized, visual continuous performance test which provides measures of attention. The stimulus, presented for 100 milliseconds (ms) at the rate of 30 per minute, is a computer-presented square containing a square hole near the top (target) or bottom (non-target) edge. The first half of the TOVA requires that the child sustain attention while the second half requires inhibition of response to a non-target. Responses to non-targets. Higher score is preferable (observed range: -82.4, 128.9).|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.||Responses to non-targets||Standard Deviation|Mean
781894|NCT00799487|Secondary|Hour 5.5 Wide Range Assessment of Memory and Learning (WRAML-2) Finger Windows Forwards|WRAML-2 (range: 0, 28) is designed to evaluate a child’s ability to learn and to memorize information, consists of 9 subtests from which 4 summary indexes can be calculated: verbal memory index, visual memory index, learning index, and general memory index. During this test the investigator pointed to a longer and longer series of windows on a card at the rate of 1 location per second, and then the child was asked to reproduce the sequence exactly. One point was given for each correctly recalled sequence, and the test was discontinued after 3 consecutive errors.|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.||Correct Sequences||Standard Deviation|Mean
781895|NCT00799487|Secondary|Hour 5.5 Wide Range Assessment of Memory and Learning (WRAML-2) Finger Windows Backwards|WRAML-2 (range: 0, 28) is designed to evaluate a child’s ability to learn and to memorize information, consists of 9 subtests from which 4 summary indexes can be calculated: verbal memory index, visual memory index, learning index, and general memory index. During this test the investigator pointed to a longer and longer series of windows on a card at the rate of 1 location per second, and then the child was asked to reproduce the sequence exactly in reverse order. One point was given for each correctly recalled sequence, and the test was discontinued after 3 consecutive errors.|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.||Correct Sequences||Standard Deviation|Mean
781896|NCT00799487|Secondary|Hour 5.5 Test of Variables of Attention(TOVA) Reaction Time Variability (Standard Deviation in Milliseconds (Msecs))|The TOVA is a computerized, visual continuous performance test which provides measures of attention. The stimulus, presented for 100 milliseconds (ms) at the rate of 30 per minute, is a computer-presented square containing a square hole near the top (target) or bottom (non-target) edge. The first half of the TOVA requires that the child sustain attention while the second half requires inhibition of response to a non-target. SD of response times (msecs) (observed range: -177.6, 132.9). Higher score indicates less variability.|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.||milliseconds||Standard Deviation|Mean
781897|NCT00799487|Secondary|Hour 5.5 Test of Variables of Attention (TOVA) Reaction Time (Msec)|The TOVA is a computerized, visual continuous performance test which provides measures of attention. The stimulus, presented for 100 milliseconds (ms) at the rate of 30 per minute, is a computer-presented square containing a square hole near the top (target) or bottom (non-target) edge. The first half of the TOVA requires that the child sustain attention while the second half requires inhibition of response to a non-target. Mean response latency in msecs (observed range: -75.4, 129.5). Higher score indicates faster reaction time.|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.||Milliseconds (msecs)||Standard Deviation|Mean
781898|NCT00799487|Secondary|Hour 5.5 Test of Variables of Attention (TOVA) ADHD Score|The TOVA is a computerized, visual continuous performance test which provides measures of attention. The stimulus, presented for 100 milliseconds (ms) at the rate of 30 per minute, is a computer-presented square containing a square hole near the top (target) or bottom (non-target) edge. The first half of the TOVA requires that the child sustain attention while the second half requires inhibition of response to a non-target (observed range: -15.2, 5.2). An ADHD score of less than -1.80 is suggestive of ADHD.|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.||Units on a scale||Standard Deviation|Mean
781899|NCT00799487|Secondary|Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Composite (SKAMP-Composite)|The SKAMP scale measures the manifestations of ADHD using an independent observer (teacher) rating of child impairment in classroom behavior. A composite score (range: 0, 78) for the SKAMP variable (13 items total) was obtained by summing the SKAMP-D and SKAMP-A subscale scores. A lower score was preferable, as a higher score represented greater behavioral impairment.|Hour 4 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.||Units on a scale||Standard Deviation|Mean
781900|NCT00799487|Secondary|Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Attention (SKAMP-Attention)|The SKAMP scale measures the manifestations of ADHD using an independent observer (teacher) rating of children impairment in classroom behavior. The SKAMP-Attention (SKAMP-A) (range: 0, 42) is a sum of the ratings on 7 attention items (getting started, sticking with tasks, attending to an activity, making activity transitions, completing assigned tasks, performing work accurately, and being neat and careful while writing or drawing). Each item was rated on a 7-point impairment scale (0=normal, 6=maximum impairment), with higher scores indicating more severe symptoms.|Hour 4 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.||Units on a scale||Standard Deviation|Mean
781901|NCT00799487|Secondary|Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Deportment (SKAMP-Deportment)|The SKAMP scale measures the manifestations of ADHD using an independent observer (teacher) rating of children impairment in classroom behavior. The SKAMP-Deportment (SKAMP-D) (range: 0,36) is a sum of ratings on 6 deportment items (interacting with other children, interacting with adults, remaining quiet, staying seated, complying with the teacher’s directions, and following the classroom rules). Each item was rated on a 7-point impairment scale (0=normal, 6=maximum impairment), with higher scores indicating more severe symptoms.|Hour 4 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.||Units on a scale||Standard Deviation|Mean
781902|NCT00799487|Primary|Hour 4 Permanent Product Math Test Correct Score (PERMP-Correct)|PERMP (range: 0, 400) is a measure of academic productivity. These seatwork math tasks provide an objective measure of attention and accuracy in calculations. The level of difficulty is established on a screening math pretest. The subsequent laboratory school day assessments employed a series of 10-minute math tests (5 pages of 80 math problem each for a total of 400 problems available). Children were graded on the number of correct problems. A higher number of problems correct, of those attempted, was indicative of greater accuracy.|Hour 4 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.||Problems correct||Standard Deviation|Mean
781903|NCT00799487|Primary|Hour 4 Permanent Product Math Test Attempted Score (PERMP-Attempted)|PERMP (range: 0, 400) is a measure of academic productivity. These seatwork math tasks provide an objective measure of attention and accuracy in calculations. The level of difficulty is established on a screening math pretest. The subsequent laboratory school day assessments employed a series of 10-minute math tests (5 pages of 80 math problem each for a total of 400 problems available). Children were graded on the number of attempted problems. A higher number of problems attempted was indicative of greater attention to detail (higher score is preferable.)|Hour 4 of the Double-Blind Assessment Period Lab School Day|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.||Problems attempted||Standard Deviation|Mean
781904|NCT00799578|Primary|Normalization or >50% of Serum ALT Levels From Baseline||6 months|||participants|||Number
781908|NCT00799591|Secondary|Percentage of Participants (> 10%) With Use of Other Antibiotics in Combination With Tigecycline Who Had Clinical Success at EOT|Combinations of antibiotic treatments for participants treated with clinical success with tigecycline. Clinical success defined as lack of need to use new antibiotic or a surgical treatment not initially planned for initial infection.|Baseline (Inclusion), End of Treatment (on the day of last dose of study treatment) or up to 25 months|ITT population; N=number of participants treated with combinations of antibiotics with analyzable data at observation.||percentage of participants|||Number
781909|NCT00799591|Secondary|Mean Duration (Days) of Treatment With Tigecycline||Baseline (Inclusion) through last dose of study treatment or up to 25 months|ITT population||days||Standard Deviation|Mean
781910|NCT00799591|Secondary|Percentage of Participants Per Tigecycline Loading Dose and Maintenance Dose|Tigecycline powder for solution 50 milligrams (mg) for intravenous (IV) infusion could be administered with an initial loading dose of 100 mg followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days. Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity.|Baseline (Inclusion) through last dose of study treatment or up to 25 months|ITT population||percentage of participants|||Number
781911|NCT00799591|Primary|Percentage of Participants Per Clinical Outcome (Success, Failure, or Undetermined) at Follow-up Visit|Clinical Success: lack of need to use new antibiotic or a surgical treatment not initially planned for initial infection. Failure: persistence of initial infection (required change of antibiotic or surgery), death related to infection (>48 hours after start of treatment with tigecycline), or premature cessation of treatment due to treatment-related Adverse Event. Undetermined: insufficient data for assessment, death not directly related to initial infection, death within first 48 hours of start of treatment with tigecycline, or additional antibiotic treatment for other than initial infection.|Follow-up Visit (7 days after last dose or at hospital discharge whichever occurred within 7 days after last dose) or up to 25 months|ITT population; N=number of participants with analyzable data at observation.||percentage of participants||95% Confidence Interval|Number
781912|NCT00799591|Primary|Percentage of Participants Per Clinical Outcome (Success, Failure, or Undetermined) at End of Treatment (EOT)|Clinical Success: lack of need to use new antibiotic or a surgical treatment not initially planned for initial infection. Failure: persistence of initial infection (required change of antibiotic or surgery), death related to infection (>48 hours after start of treatment with tigecycline), or premature cessation of treatment due to treatment-related Adverse Event. Undetermined: insufficient data for assessment, death not directly related to initial infection, death within first 48 hours of start of treatment with tigecycline, or additional antibiotic treatment for other than initial infection.|End of Treatment (on the day of last dose of study treatment) or up to 25 months|Intent-to-Treat (ITT): all participants included in the study who received at least 1 dose of study treatment.||percentage of participants||95% Confidence Interval|Number
781913|NCT00799604|Primary|The Mean Maximum Percent Change in Systolic Blood Pressure From Baseline Within 15 Minutes From the First Bolus Dose of Clevidipine (Treatment Period 1, Bolus 1 - Pre-anesthesia).|Blood Pressure was measured at 60, 45, 30, 0 seconds prior to first Bolus dose (Bolus 1), and every 5 seconds after Bolus 1 for 15 minutes. Baseline SBP of Bolus 1 is defined as, 'median of all measurements prior to or at the start of Bolus 1'. Locally weighted scatterplot smoothing (LOWESS) method was used to determine the minimum SBP value for each patient. Maximum percent change is defined as the maximum absolute change divided by the baseline value of bolus 1 and multiplied by 100.|From start to 15 minutes of Bolus 1 dose of clevidipine (pre-anesthesia).|Modified Intent-to-Treat (mITT) population: all enrolled patients who were deemed eligible for the study by meeting all inclusion and no exclusion criteria and were treated with clevidipine. The mITT population is the primary population for the analyses of efficacy.||percent change||Standard Deviation|Mean
781914|NCT00799604|Secondary|Change in Heart Rate After Bolus 1 (Pre-anesthesia).|The baseline heart rate was measured as the median of all the heart rate measurements within 60 seconds or at the start of the administration of Bolus 1.|Baseline up until the first 15 minutes following Bolus 1 (pre-anesthesia).|Safety population: all enrolled patients (irrespective of eligibility) who are dosed with clevidipine. The safety population will be the primary population used for the safety analyses.||beats per minute (bpm)||Standard Deviation|Mean
781915|NCT00799604|Secondary|The Median Time to 50%, and, When Available, 90% Recovery From Maximum SBP Effect Following the First Bolus Dose of Clevidipine for Patients Who Achieved the Endpoints (Treatment Period 1, Bolus 1 - Pre-anesthesia).|Analysis is of the time in minutes between the recorded time at the maximum absolute change and the time of the systolic blood pressure value at the first 50% recovery. The 50% recovery value is equal to the minimum recorded systolic blood pressure value plus 50% of the maximum amount of systolic blood pressure reduction (the Bolus 1 baseline value minus the value at the maximum absolute change).|Up to 15 minutes following the first bolus dose of clevidipine (pre-anesthesia).|Modified Intent-to-Treat (mITT) population: all enrolled patients who are eligible for the study and treated with clevidipine. The mITT population will be the primary population for the analyses of efficacy.||minutes||95% Confidence Interval|Median
781916|NCT00799604|Secondary|The Mean Percent Change in Systolic Blood Pressure From Baseline Over Time During the First 15 Minutes Following First Bolus Dose of Clevidipine (Treatment Period 1, Bolus 1 - Pre-anesthesia).|BP was measured at 60, 45, 30, 0 seconds prior to first Bolus dose (Bolus 1), and every 5 seconds after Bolus 1 for 15 minutes. Baseline SBP of Bolus 1 is defined as median of all measurements prior to or at the start of Bolus 1. SBP change (percent change) from baseline is calculated at each collection time point after bolus 1 dose for each patient.|From start to 15 minutes of Bolus 1 of clevidipine (pre-anesthesia).|Modified Intent-to-Treat (mITT) population: all enrolled patients who are eligible for the study and treated with clevidipine. The mITT population will be the primary population for the analyses of efficacy.||percent change||Standard Deviation|Mean
781917|NCT00799604|Secondary|The Median Time to 5%, 10%, and 15% Systolic Blood Pressure Reduction From Baseline Within 15 Minutes From the First Bolus Dose of Clevidipine (Treatment Period 1, Bolus 1 -Pre-anesthesia).|BP was measured at 60, 45, 30, 0 seconds prior to first Bolus dose (bolus 1), and every 5 seconds after Bolus 1 for 15 minutes. Baseline SBP of bolus 1 is defined as median of all measurements prior to or at the start of Bolus 1. The time at which first target SBP reduction (ex. 5%) from baseline was reached was identified for each patient using fitted values from LOWESS method. Kaplan-Meier method was used to estimate the median time. Patients who never reached 5%, 10% or 15% reduction, withdrew from study or changed antihypertensive within 15 minutes were censored.|From start to 15 minutes of Bolus 1 of clevidipine (pre-anesthesia).|Modified Intent-to-Treat (mITT) population: all enrolled patients who are eligible for the study and treated with clevidipine. The mITT population will be the primary population for the analyses of efficacy.||minutes||95% Confidence Interval|Median
781918|NCT00799604|Secondary|The Percentage of Patients With Systolic Blood Pressure ≤85 mm Hg Within 15 Minutes From the First Bolus Dose of Clevidipine (Treatment Period 1, Bolus 1 - Pre-anesthesia).|The percentage is calculated using the number of patients with a systolic blood pressure ≤85 mm Hg within 15 minutes from the initial Bolus 1 dose divided by the total number of patients who were treated with a Bolus 1 clevidipine, and multiplied by 100.|From start to 15 minutes of Bolus 1 dose of clevidipine (pre-anesthesia).|Modified Intent-to-Treat (mITT) population: all enrolled patients who are eligible for the study and treated with clevidipine. The mITT population will be the primary population for the analyses of efficacy.||percent patients||95% Confidence Interval|Number
781919|NCT00799604|Primary|The Mean Maximum Absolute Change in Systolic Blood Pressure From Baseline Within 15 Minutes From the First Bolus Dose of Clevidipine (Treatment Period 1, Bolus 1 - Pre-anesthesia).|Blood Pressure was measured at 60, 45, 30, 0 seconds prior to first Bolus dose (Bolus 1), and every 5 seconds after Bolus 1 for 15 minutes. Baseline SBP of Bolus 1 is defined as, 'median of all measurements prior to or at the start of Bolus 1'. Locally weighted scatterplot smoothing (LOWESS) method was used to determine the minimum SBP value for each patient. Maximum absolute change is the minimum SBP value within 15 minutes from bolus 1 minus baseline value.|From start to 15 minutes of Bolus 1 dose of clevidipine (pre-anesthesia).|Modified Intent-to-Treat (mITT) population: all enrolled patients who were deemed eligible for the study by meeting all inclusion and no exclusion criteria and were treated with clevidipine. The mITT population is the primary population for the analyses of efficacy.||mm Hg||Standard Deviation|Mean
781966|NCT00799773|Secondary|B-cell Depletion in Relation to ADAMTS-13 Activity and to ADAMTS-13 Antibody Levels and Disease Activity in Participants Who Receive Rituximab Versus Those Who do Not||Measured at Month 12|The STAR informed consent form told subjects their data would be combined with other subjects’ data in study reports. Because one treatment arm included only one subject, this subject’s data cannot be combined with other subjects’ data. Therefore, to protect subject confidentiality, results are not being released for this study.|||||
781957|NCT00799643|Secondary|Response Rates in Patients Initially Treated With Lifestyle Modification, Insulin Secretagogue, Metformin or Combination Therapy||24 and 48 weeks||||||
781958|NCT00799643|Secondary|Response Rates for Exceeding Hyperglycemic Targets Between Active and Placebo Treated Groups; Need for Rescue Therapy; Need for Discontinuation of Study Medication||24 and 48 weeks||||||
781959|NCT00799643|Secondary|Changes in WBC and Differential, High-sensitivity C Reactive Protein (hsCRP), Other Inflammatory Markers||24 and 48 weeks||||||
781960|NCT00799643|Secondary|Change in Lipids (Low-density Lipoprotein Cholesterol [LDL-C], Non-high-density Lipoprotein Cholesterol [Non-HDL-C], Triglycerides [TG], Total Cholesterol [TC], High-density Lipoprotein Cholesterol [HDL C], TC/HDL-C Ratio, and LDL-C/HDL-C Ratio)||48 weeks||||||
781961|NCT00799643|Secondary|Response Rates for Reduction in Fasting Glucose of ≥20 mg/dl, a Reduction in HbA1c of ≥0.5%, and a Reduction in HbA1c of ≥0.8%||24 and 48 weeks||||||
781962|NCT00799643|Secondary|Change From Baseline in Fasting Glucose Over Time.||48 weeks from baseline|Participants with complete data at both Baseline and 48 weeks||mg/dl||95% Confidence Interval|Mean
781963|NCT00799643|Primary|The Primary Outcome for the TINSAL-T2D Study is Change in HbA1c Level From Baseline to Week 48 From Baseline, Compared Between Treatment Groups.|HbA1c (%, percentage of HbA1c) change from baseline.|48 weeks from baseline|Participants with complete data at both Baseline and 48 weeks||HbA1c units are %||95% Confidence Interval|Mean
781964|NCT00799708|Secondary|Change From Baseline in Minor Gland Salivary Flow Rate After Treatment With 2 mg Estradiol vs Placebo at Day 7.|Change from baseline in unstimulated labial gland saliva flow rate at Day 7|Baseline and Day 7|All subjects with salivary flow rate measured at baseline and 7 days||μL/min||90% Confidence Interval|Least Squares Mean
781965|NCT00799708|Primary|Change From Baseline in Estrogen Receptor Beta (ERbeta) -Specific Gene Signature After Treatment With 2 mg, 0.5 mg, or no Estradiol (Placebo) at Day 7|Subset of genes on the log ratio intensity scale from a microarray platform – signature was pre-specified from an internally conducted study in knock-out mice treated with estrogens– quantified as a ratio of up regulated versus down regulated genes|Baseline and Day 7|All subjects with salivary gland tissue with RNA of acceptable quality based on pre-specified QC criteria||Fold change||Standard Error|Least Squares Mean
781967|NCT00799773|Secondary|Effect of Rituximab Levels on the Extent of B-cell Depletion (CD-19+ Cells)||Measured at Month 12|The STAR informed consent form told subjects their data would be combined with other subjects’ data in study reports. Because one treatment arm included only one subject, this subject’s data cannot be combined with other subjects’ data. Therefore, to protect subject confidentiality, results are not being released for this study.|||||
781968|NCT00799773|Secondary|Effect of Plasma Exchange on Rituximab Levels||Measured at Month 6|The STAR informed consent form told subjects their data would be combined with other subjects’ data in study reports. Because one treatment arm included only one subject, this subject’s data cannot be combined with other subjects’ data. Therefore, to protect subject confidentiality, results are not being released for this study.|||||
781969|NCT00799773|Secondary|Rituximab Response in Participants With Varying Levels of ADAMTS-13 Activity and Antibodies Against ADAMTS-13||Measured at Month 36|The STAR informed consent form told subjects their data would be combined with other subjects’ data in study reports. Because one treatment arm included only one subject, this subject’s data cannot be combined with other subjects’ data. Therefore, to protect subject confidentiality, results are not being released for this study.|||||
781970|NCT00799773|Secondary|Evaluating How Levels of ADAMTS-13 Enzyme and Autoantibody at Specific Time Points or Over the Course of the Study Correlate With Other Indicators of Disease Activity, Remission Rates, Rapidity of Achieving a Remission, and Recurrence Rate||Measured at Month 36|The STAR informed consent form told subjects their data would be combined with other subjects’ data in study reports. Because one treatment arm included only one subject, this subject’s data cannot be combined with other subjects’ data. Therefore, to protect subject confidentiality, results are not being released for this study.|||||
781971|NCT00799773|Secondary|Treatment-related Complications||Measured at Day 52|The STAR informed consent form told subjects their data would be combined with other subjects’ data in study reports. Because one treatment arm included only one subject, this subject’s data cannot be combined with other subjects’ data. Therefore, to protect subject confidentiality, results are not being released for this study.|||||
781972|NCT00799773|Secondary|All Cause Mortality||Measured at Month 36|The STAR informed consent form told subjects their data would be combined with other subjects’ data in study reports. Because one treatment arm included only one subject, this subject’s data cannot be combined with other subjects’ data. Therefore, to protect subject confidentiality, results are not being released for this study.|||||
781973|NCT00799773|Secondary|Incidence of Relapse Among Participants in the Two Study Groups Who Achieve Early Treatment Response||Measured at Month 36|The STAR informed consent form told subjects their data would be combined with other subjects’ data in study reports. Because one treatment arm included only one subject, this subject’s data cannot be combined with other subjects’ data. Therefore, to protect subject confidentiality, results are not being released for this study.|||||
781974|NCT00799773|Secondary|Relationship Between Clinical and Laboratory Data and Response to Treatment||Measured at Days 52 and 82|The STAR informed consent form told subjects their data would be combined with other subjects’ data in study reports. Because one treatment arm included only one subject, this subject’s data cannot be combined with other subjects’ data. Therefore, to protect subject confidentiality, results are not being released for this study.|||||
781975|NCT00799773|Secondary|Whether Participants Receiving Rituximab Achieve Early or Late Treatment Response Faster and Require Fewer Plasma Exchanges Than Participants Not Receiving Rituximab||Measured at Days 52 and 82|The STAR informed consent form told subjects their data would be combined with other subjects’ data in study reports. Because one treatment arm included only one subject, this subject’s data cannot be combined with other subjects’ data. Therefore, to protect subject confidentiality, results are not being released for this study.|||||
781976|NCT00799773|Secondary|Use of Non-study Treatment||Measured at Month 36|The STAR informed consent form told subjects their data would be combined with other subjects’ data in study reports. Because one treatment arm included only one subject, this subject’s data cannot be combined with other subjects’ data. Therefore, to protect subject confidentiality, results are not being released for this study.|||||
781977|NCT00799773|Primary|Role of Rituximab in Increasing Early Treatment Response in Participants With TTP Who Are Also Treated With Plasma Exchange and Corticosteroids||Measured at Day 52|The STAR informed consent form told subjects their data would be combined with other subjects’ data in study reports. Because one treatment arm included only one subject, this subject’s data cannot be combined with other subjects’ data. Therefore, to protect subject confidentiality, results are not being released for this study.|||||
781978|NCT00799825|Primary|Number of Subjects With Pregnancies and Pregnancy Outcomes.||Throughout the study (up to Month 12)|The analysis was based on pregnant subjects from the Total Vaccinated cohort, which included all subjects who received at least one dose of Cervarix vaccine in this study, for whom data were available.||Subjects|||Number
781979|NCT00799825|Primary|Number of Subjects With Any, Grade 3 and Related Medically Significant Conditions (MSCs)|MSCs = Adverse events (AEs) prompting emergency room/physician visits not related to common diseases or routine visits for physical examination/vaccination, or SAEs not related to common diseases. Common diseases include: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury. Any = Occurrence of any MSC regardless of intensity grade or relation to vaccination. Grade 3 = MSC which prevented normal, everyday activities. Related = MSC assessed by the investigator as related to the vaccination.|Throughout the study (up to Month 12)|The analyses were performed on the Total Vaccinated cohort, which included all subjects who received at least one dose of Cervarix vaccine in this study, for whom data were available.||Subjects|||Number
781980|NCT00799825|Primary|Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Any = Occurrence of any SAE regardless of intensity grade or relation to vaccination. Grade 3 = SAE which prevented normal, everyday activities. Related = SAE assessed by the investigator as related to the vaccination.|Throughout the study (up to Month 12)|The analyses were performed on the Total Vaccinated cohort, which included all subjects who received at least one dose of Cervarix vaccine in this study, for whom data were available.||Subjects|||Number
781981|NCT00799903|Secondary|Number of Participants With All-cause Mortality During the Time Period for Vital Status|The number of participants with all-cause mortality was assessed.|From randomization until death or study completion (up to 4.49 years/average of 3.65 years)|All Randomized (ITT) Population||Participants|||Count of Participants
785479|NCT00837148|Primary|Overall Objective Response|Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1)|at 18 weeks|||participants|||Number
781982|NCT00799903|Secondary|Number of Participants With First Occurrence of Any Component of the Composite of All-cause Mortality, Non-fatal MI, or Non-fatal Stroke During the Time Period for Follow-up of CV Events|Acute MI is defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI. Stroke=presence of a new focal neurologic deficit thought to be of vascular origin, with signs/symptoms lasting >24 hours or results in death (in <24 hours).|From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)|All Randomized (ITT) Population||Participants|||Count of Participants
781983|NCT00799903|Secondary|Number of Participants With First Occurrence of Stroke (Fatal/Non-fatal) During the Time Period for Follow-up of CV Events|Stroke is defined as the presence of a new focal neurologic deficit thought to be of vascular origin, with signs/symptoms lasting >24 hours or results in death (in <24 hours).|From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)|All Randomized (ITT) Population||Participants|||Count of Participants
781984|NCT00799903|Secondary|Number of Participants With First Occurrence of MI (Fatal/Non-fatal) During the Time Period for Follow-up of CV Events|Acute MI is defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI.|From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)|All Randomized (ITT) Population||Participants|||Count of Participants
781985|NCT00799903|Secondary|Number of Participants With CV Death During the Time Period for Follow-up of CV Events|CV death is defined as a death due to a CV cause, which included but was not limited to deaths resulting from stroke, arrhythmia, sudden death (witnessed/unwitnessed), MI, heart failure, pulmonary embolism, peripheral arterial disease, or complications of a CV procedure. Deaths not clearly attributable to non-CV causes are considered to be CV deaths.|From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)|All Randomized (ITT) Population||Participants|||Count of Participants
781986|NCT00799903|Secondary|Number of Participants With First Occurrence of Any Event in the Composite of Total Coronary Events (CHD Death, Non-fatal MI, Hospitalization for Unstable Angina, or Any Coronary Revascularization Procedure) During Time Period for FU of CV Events|CHD death, acute MI, and prior MI are defined in the previous secondary endpoint (major coronary events). Hospitalization for unstable angina=one of the following, but not fulfilling the criteria for MI: ischemic discomfort at rest associated with electrocardiogram (ECG) changes leading to hospitalization; ischemic discomfort at rest regardless of ECG changes leading to hospitalization and revascularization during the same admission; ischemic discomfort at rest in hospital associated with ECG changes; ischemic discomfort at rest in hospital without ECG changes resulting in revascularization during the same admission. NOTE: The event was not considered to be unstable angina if, after invasive/non-invasive testing or other diagnostic testing, the discomfort is found not to be caused by myocardial ischemia.|From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)|All Randomized (ITT) Population||Participants|||Count of Participants
781987|NCT00799903|Secondary|Number of Participants With First Occurrence of Any Event in the Composite of Major Coronary Events (Coronary Heart Disease [CHD] Death, Non-fatal MI, or Urgent Coronary Revascularization [CR] for MI) During the Time Period for Follow-up (FU) of CV Events|CHD death=occurrence of a fatal MI, death caused by documented cardiac arrest, death resulting from heart failure in a participant with known CHD, death from other forms of acute/chronic CHD, unwitnessed death of unknown origin, or sudden death. Acute MI=evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g.,silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI. Urgent CR for MI=ischemic discomfort at rest that prompted CR (percutaneous coronary intervention [PCI: any attempt at CR even if not successful] or coronary artery bypass graft) during the same hospitalization or resulted in hospital transfer for the purpose of CR.|From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)|All Randomized (ITT) Population||Participants|||Count of Participants
781988|NCT00799903|Primary|Number of Participants With First Occurrence of Any Component of the Composite of Major Adverse Cardiovascular Events (Cardiovascular [CV] Death, Non-fatal Myocardial Infarction [MI] or Non-fatal Stroke) During the Time Period for Follow-up of CV Events|CV death=death due to a CV cause, which included but was not limited to deaths resulting from stroke, arrhythmia, sudden death (witnessed/unwitnessed), MI, heart failure, pulmonary embolism, peripheral arterial disease, or complications of a CV procedure. Deaths not clearly attributable to non-CV causes are considered to be CV deaths. Acute MI=evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI. Stroke=presence of a new focal neurologic deficit thought to be of vascular origin, with signs/symptoms lasting >24 hours or results in death (in <24 hours).|From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)|All-randomized Intent-to-treat (ITT) population comprised of all randomized participants.||Participants|||Count of Participants
785522|NCT00837512|Primary|Onset Time (Tmax)|Average time to peak insulin concentration|0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4 hours|||Minutes||Standard Deviation|Mean
781989|NCT00800202|Secondary|Percentage of Participants Achieving a Best Overall Response of Complete Response or Partial Response as Assessed by the Investigator Using RECIST|Overall response defined as best response according to RECIST recorded from date of randomization until disease progression or recurrence. Complete Response (CR): disappearance of all target lesions; Partial response (PR): reduction by at least 30 percent (%) of sum of the longest diameters of each target lesion, taking initial sum of longest diameters as a reference. Participants with a missing response were considered non-responders. 95% CI for one sample binomial using Pearson-Clopper method.|Screening, Day 1 of Cycles 3 and 5 and every 2 cycles until end of treatment visit or disease progression or death up to 18 months after enrollment of last participant|ITT Population||percentage of participants||95% Confidence Interval|Number
781990|NCT00800202|Secondary|Time to Death|Time to death was determined as the number of months between the first dose of study treatment and the event of death by any cause. Overall survival was analyzed using the Kaplan-Meier method.|Day 1 of Cycles 1, 2, 3, 4, 5, 6 and every 3 weeks up to 18 months or until death|ITT Population; only participants with an event of death were included in the analysis.||months||95% Confidence Interval|Median
781991|NCT00800202|Secondary|Probability of Being Alive at 12 and 18 Months||Months 12 and 18|ITT Population||percent||95% Confidence Interval|Number
781992|NCT00800202|Secondary|Percentage of Participants Who Died||Day 1 of Cycles 1, 2, 3, 4, 5, 6 and every 3 weeks up to 18 months or until death|ITT Population||percentage of participants|||Number
781993|NCT00800202|Primary|Time to Disease Progression or Death|Tumor progression was defined as increase by at least 20% in the sum of the longest diameters of each target lesion, taking as a reference the smallest sum of the longest diameters, reported since the start of treatment, or appearance of one or more new lesions. Time to event was determined as the number of months between the first dose of study treatment and the first event of progression or death by any cause. PFS was analyzed using the Kaplan-Meier method in each treatment arm.|Screening, Day 1 of Cycles 3 and 5 and every 2 cycles until end of treatment visit or disease progression or death up to 18 months after enrollment of last participant|ITT Population; only participants with progression or death were included in the analysis.||months||95% Confidence Interval|Median
781994|NCT00800202|Primary|Percentage of Participants With Disease Progression or Death|Tumor progression was defined according to the RECIST criteria as increase by at least 20% in the sum of the longest diameters of each target lesion, taking as a reference the smallest sum of the longest diameters, reported since the start of treatment, or appearance of one or more new lesions. PFS (investigator assessed) was defined as the time between the first dose of study treatment and the first event of progression or death by any cause. Participants without an event were censored the last time they were known to be progression free. PFS was analyzed using the Kaplan-Meier method in each treatment arm.|Screening, Day 1 of Cycles 3 and 5 and every 2 cycles until end of treatment visit or disease progression or death up to 18 months after enrollment of last participant|ITT Population||percentage of participants|||Number
781995|NCT00800202|Primary|Percentage of Participants Achieving Progression-Free Survival (PFS) Without Disease Progression or Death at 6 Months|Tumor progression was defined according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 as increase by at least 20% in the sum of the longest diameters of each target lesion, taking as a reference the smallest sum of the longest diameters, reported since the start of treatment, or appearance of one or more new lesions. PFS (investigator assessed) was defined as the time between the first dose of study treatment and the first event of progression or death by any cause. Participants without an event were censored the last time they were known to be progression free. PFS was analyzed using the Kaplan-Meier method in each treatment arm.|6 months|ITT Population||percentage of participants||95% Confidence Interval|Number
781996|NCT00800254|Secondary|Functional Performance Measure: Stair-Climbing Test [SCT] at 1 Year Post-operatively|The SCT assesses the time it takes for a patient to ascend a flight of stairs, turn around, and descend the same flight of stairs.|1 year post-operatively|The Participant Flow represents overall study enrollment and withdrawals. In some cases, patients may have returned for testing, but been unable to complete every test due to time constraints, fatigue, or in some cases, inability.||seconds||Standard Deviation|Mean
781997|NCT00800254|Secondary|"Functional Performance Measure: Timed Up & Go Test [TUG] at 1 Year Post-operatively"|The TUG assesses time in seconds to rise from an armchair, walk 3 meters, turn around, and return to sitting in the same chair without physical assistance.|1 year post-operatively|The Participant Flow represents overall study enrollment and withdrawals. In some cases, patients may have returned for testing, but been unable to complete every test due to time constraints, fatigue, or in some cases, inability.||seconds||Standard Deviation|Mean
781998|NCT00800254|Secondary|Functional Performance Measure: Six-Minute Walk Test [6MWT]) at 1 Year Post-operatively|The 6MWT assesses the total distance in meters a patient walks at a self-selected pace over a 6 minute interval.|1 year post-operatively|The Participant Flow represents overall study enrollment and withdrawals. In some cases, patients may have returned for testing, but been unable to complete every test due to time constraints, fatigue, or in some cases, inability.||meters||Standard Deviation|Mean
781999|NCT00800254|Secondary|Functional Performance Measure: Stair-Climbing Test [SCT] at 3.5 Weeks Post-operatively|The SCT assesses the time it takes for a patient to ascend a flight of stairs, turn around, and descend the same flight of stairs.|3.5 weeks post-operatively|The Participant Flow represents overall study enrollment and withdrawals. In some cases, patients may have returned for testing, but been unable to complete every test due to time constraints, fatigue, or in some cases, inability.||seconds||Standard Deviation|Mean
782000|NCT00800254|Secondary|"Functional Performance Measure: Timed Up & Go Test [TUG] at 3.5 Weeks Post-operatively"|The TUG assesses time in seconds to rise from an armchair, walk 3 meters, turn around, and return to sitting in the same chair without physical assistance.|3.5 weeks post-operatively|The Participant Flow represents overall study enrollment and withdrawals. In some cases, patients may have returned for testing, but been unable to complete every test due to time constraints, fatigue, or in some cases, inability.||seconds||Standard Deviation|Mean
782001|NCT00800254|Secondary|Functional Performance Measure: Six-Minute Walk Test [6MWT]) at 3.5 Weeks Post-operatively|The 6MWT assesses the total distance in meters a patient walks at a self-selected pace over a 6 minute interval.|3.5 weeks post-operatively|The Participant Flow represents overall study enrollment and withdrawals. In some cases, patients may have returned for testing, but been unable to complete every test due to time constraints, fatigue, or in some cases, inability.||meters||Standard Deviation|Mean
782002|NCT00800254|Secondary|Change From Baseline in Isometric Quadriceps Muscle Torque 1-Year Post-operatively|A HUMAC NORM electromechanical dynamometer was used to measure isometric torque generation in quadriceps muscle stabilized with 60 degrees of knee flexion.|Baseline through 1 year|The Participant Flow represents overall study enrollment and withdrawals. In some cases, patients may have returned for testing, but been unable to complete every test due to time constraints, fatigue, or in some cases, inability.||change in N-m/kg||Standard Deviation|Mean
782003|NCT00800254|Primary|Change From Baseline in Isometric Quadriceps Muscle Torque 3.5 Weeks Post-operatively|A HUMAC NORM electromechanical dynamometer was used to measure isometric torque generation in quadriceps muscle stabilized with 60 degrees of knee flexion.|Baseline through 3.5 weeks|The Participant Flow represents overall study enrollment and withdrawals. In some cases, patients may have returned for testing, but been unable to complete every test due to time constraints, fatigue, or in some cases, inability.||change in N-m/kg||Standard Error|Mean
782004|NCT00800345|Secondary|Treatment Response|Treatment response was evaluated using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is >=30% decrease in the sum of the longest diameter (LD) of target lesions; Stable Disease (SD) is neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of >=20%; Progressive Disease (PD) is the increase in existing lesions or new lesions.|After every 2 cycles of treatment beginning on Cycle 1 Day 1, up to 38 months|||participants|||Number
782005|NCT00800345|Primary|Dose Limiting Toxicity (DLT)||Cycle 1 (28 days)|||participants|||Number
782006|NCT00800384|Secondary|Perioperative Complication Rate|A predefined set of expected complications attributed to defibrillation testing during implant procedure was analyzed in both groups.|30 days|Perioperative complication rate was assessed in patients undergoing ICD implant. Number of patients having experienced at least one of the predefined complications was assessed.||participants|||Number
782007|NCT00800384|Primary|First Occurrence of the Composite of Failed First Appropriate Clinical Shock From the Implantable Cardioverter Defibrillator (ICD) or Arrhythmic Death|The number of patients having experienced either an appropriate inefficient shock and/or arrhythmic death during the follow-up time frame of 3.1 years is compared between both groups.|Mean follow-up of 3.1 years|All patients were analyzed as per intention to treat. An on treatment analysis was performed in 1190 patients in the group without defibrillation testing and in 1165 patients in the group with defibrillation testing.||participants|||Number
782008|NCT00800436|Secondary|Terminal Elimination Half-Life (T1/2) of Trastuzumab|T1/2 of trastuzumab was measured as the time required for trastuzumab concentration to decrease by one-half. T1/2 was derived across all PK collections and expressed in hours.|Postdose from start of 1.5-hour infusion (1.5 and 3 hours for IV) (6, 8, 12 hours for SC) on Day 1; on Days 2, 3, 5, 8, 15, 22, 43, 85; additionally on Day 10 for SC and Day 35 for IV; and 5 months postdose (up to 5 months overall)|PK Population||hours||Standard Deviation|Mean
782009|NCT00800436|Secondary|Time to Maximum Serum Concentration (Tmax) of Trastuzumab|Tmax of trastuzumab was based on the Cmax derived across all post-dose PK collections and expressed in hours.|Postdose from start of 1.5-hour infusion (1.5 and 3 hours for IV) (6, 8, 12 hours for SC) on Day 1; on Days 2, 3, 5, 8, 15, 22, 43, 85; additionally on Day 10 for SC and Day 35 for IV; and 5 months postdose (up to 5 months overall)|PK Population||hours||Full Range|Median
782010|NCT00800436|Secondary|Maximum Observed Serum Concentration of Trastuzumab (Cmax)|Cmax of trastuzumab was derived across all post-dose PK collections and expressed in μg/mL.|Postdose from start of 1.5-hour infusion (1.5 and 3 hours for IV) (6, 8, 12 hours for SC) on Day 1; on Days 2, 3, 5, 8, 15, 22, 43, 85; additionally on Day 10 for SC and Day 35 for IV; and 5 months postdose (up to 5 months overall)|PK Population||μg/mL||Standard Deviation|Mean
782011|NCT00800436|Secondary|Trough Serum Concentration on Day 22 (CDay22) of Trastuzumab|CDay22 of trastuzumab was derived from the single PK collection on Day 22 and expressed in micrograms per milliliter (μg/mL).|Day 22|PK Population||μg/mL||Standard Deviation|Mean
782012|NCT00800436|Primary|Area Under the Concentration-Time Curve Extrapolated to Infinity (AUCinf) of Trastuzumab|AUCinf represents the area under the concentration-time curve of trastuzumab in serum over the time interval from 0 extrapolated to infinity. Values for AUCinf of trastuzumab were derived by non-compartmental analysis across all pharmacokinetic (PK) collections and expressed in days by micrograms per milliliter (days•μg/mL).|Predose (0 hours) and postdose from start of 1.5-hour infusion (1.5 and 3 hours for IV) (6, 8, 12 hours for SC) on Day 1; on Days 2, 3, 5, 8, 15, 22, 43, 85; additionally on Day 10 for SC and Day 35 for IV; and 5 months postdose (up to 5 months overall)|PK Population: All enrolled participants who adhered to the protocol (per protocol basis).||days•μg/mL||Standard Deviation|Mean
782013|NCT00800540|Secondary|Mean Change From Baseline in Peak Systolic Velocity in the Central Retinal Artery at Week 6|Peak systolic velocity in the central retinal artery was assessed using Color Doppler Imaging (CDI). Assessments were made at 7 time points over a 24-hour period.|Week 0, Week 6 (period-based)|This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT). The analysis is based on patient eye-matched image data received.||cm/s (centimeters per second)|Participants|Standard Error|Mean
782014|NCT00800540|Secondary|Mean Change From Baseline in Peak Systolic Velocity in the Ophthalmic Artery at Week 6|Peak systolic velocity in the ophthalmic artery was assessed using Color Doppler Imaging (CDI). Assessments were made at 7 time points over a 24-hour period.|Week 0, Week 6 (period-based)|This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT). The analysis is based on patient eye-matched image data received.||cm/s (centimeters per second)|Participants|Standard Error|Median
782015|NCT00800540|Secondary|Mean Change From Baseline in End Diastolic Velocity in the Ophthalmic Artery at Week 6|End diastolic velocity in the ophthalmic artery was assessed using Color Doppler Imaging (CDI). Assessments were made at 7 time points over a 24-hour period.|Week 0, Week 6 (period-based)|This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT). The analysis is based on patient eye-matched image data received.||cm/s (centimeters per second)|Participants|Standard Error|Mean
782085|NCT00810771|Secondary|Intent to Get Colorectal Cancer Screening.|Outcome measure measuring intent to get CRC screening using 5-item stage of readiness scale. Intent is measured by looking at the highest 2 items (I think I will get screened and I am committed to getting screened).|3-5 days after Decider Guider intervention.|Data was not collected for Usual Care arm.||percentage of participants|||Number
782016|NCT00800540|Secondary|Mean Change From Baseline in Vascular Resistance in the Ophthalmic Artery at 6 Weeks|Vascular resistance in the ophthalmic artery was assessed using Color Doppler Imaging (CDI). Assessments were made at 7 time points over a 24-hour period.|Week 0, Week 6 (period-based)|This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT). The analysis is based on patient eye-matched image data received.||cm/s (centimeters per second)|Participants|Standard Error|Mean
782017|NCT00800540|Secondary|Mean Change From Baseline in Vascular Resistance in the Central Retinal Artery at Week 6|Vascular resistance in the central retinal artery was assessed using Color Doppler Imaging (CDI). Assessments were made at 7 time points over a 24-hour period.|Week 0, Week 6 (period-based)|This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT). The analysis is based on patient eye-matched image data received.||cm/s (centimeters per second)|Participants|Standard Error|Mean
782018|NCT00800540|Secondary|Mean Change From Baseline in Systolic Blood Pressure at Week 6|Blood pressure is defined as the pressure exerted by circulating blood upon the walls of the blood vessels, that is, arterial pressure of the systemic circulation of blood. Systolic blood pressure refers to the maximum pressure, that is, the pressure while the heart is beating, and was measured at 7 timepoints in a 24-hour period using a calibrated sphygmomonometer. Higher blood pressure (outside the normal range) can be a risk factor for developing cardiovascular events, such as heart attack, stroke, or heart failure. Lower blood pressure (outside the normal range) can be a risk factor for dizziness or fainting.|Week 0, Week 6 (period-based)|This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT).||mmHg (millimeters of mercury)||Standard Error|Mean
782019|NCT00800540|Secondary|Mean Change From Baseline in Diastolic Blood Pressure at Week 6|Blood pressure is defined as the pressure exerted by circulating blood upon the walls of the blood vessels, that is, arterial pressure of the systemic circulation of blood. Diastolic blood pressure refers to the minimum pressure, that is, the pressure between heartbeats. Diastolic glood pressure was measured at 7 timepoints in a 24-hour period using a calibrated sphygmomonometer. Higher blood pressure (outside the normal range) can be a risk factor for developing cardiovascular events, such as heart attack, stroke, or heart failure. Lower blood pressure (outside the normal range) can be a risk factor for dizziness or fainting.|Week 0, Week 6 (period-based)|This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT).||mmHg (millimeters of mercury)||Standard Error|Mean
782020|NCT00800540|Secondary|Mean Change From Baseline in Intraocular Pressure (IOP) at Week 6|Intraocular pressure (IOP) is defined as the fluid pressure inside the eye. Intraocular pressure was measured with a calibrated pneumatonometer at 7 time points over a 24-hour period. High IOP (outside the normal range) can be a risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).|Week 0, Week 6 (period-based)|This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT).||mmHg (millimeters of mercury)|Participants|Standard Error|Mean
782021|NCT00800540|Secondary|Mean Change From Baseline in Mean Flow Value in the Inverotemporal Peripapillary Retina at Week 6|Retinal perfusion assessments were made using Heidelberg Retinal Flowmetry (HRF). Assessments were made at 4 timepoints over a 12-hour period. Intensity of blood flow was measured in arbitrary units, with a higher number indicating an increased blood flow. An increase in ocular blood flow may reduce the risk of glaucoma progression.|Week 0, Week 6 (period-based)|This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT). The analysis is based on patient eye-matched image data received.||Arbitrary Units|Participants|Standard Error|Mean
782022|NCT00800540|Secondary|Mean Change From Baseline in Mean Flow Value in the Superotemporal Peripapillary Retina at Week 6|Retinal perfusion assessments were made using Heidelberg Retinal Flowmetry (HRF). Assessments were made at 4 timepoints over a 12-hour period. Intensity of blood flow was measured in arbitrary units, with a higher number indicating an increased blood flow. An increase in ocular blood flow may reduce the risk of glaucoma progression.|Week 0, Week 6 (period-based)|This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT). The analysis is based on patient eye-matched image data received.||Arbitrary Units|Participants|Standard Error|Mean
782023|NCT00800540|Secondary|Mean Change From Baseline in Circadian Diastolic Ocular Perfusion Pressure at Week 6|Circadian diastolic ocular perfusion pressure (COPP) is defined as the variations in diastolic OPP during the day and night. Diastolic ocular perfusion pressure was calculated at 7 timepoints over a 24-hour period. Changes in the diastolic ocular perfusion pressure rhythm throughout the day (outside the normal range) may affect glaucoma progression.|Week 0, Week 6 (period-based)|This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT).||mmHg (millimeters of mercury)|Participants|Standard Error|Mean
782024|NCT00800540|Primary|Mean Change From Baseline in Overall Diastolic Ocular Perfusion Pressure at Week 6|Diastolic ocular perfusion pressure (DOPP) is defined as the difference between diastolic arterial pressure and intraocular pressure. Diastolic arterial pressure was measured with a calibrated automated sphygmomanometer. Intraocular pressure was measured with a calibrated pneumatonometer. A lower DOPP indicates a lower optic blood supply, which can be a risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).|Week 0, Week 6 (period-based)|This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT).||mmHg (millimeters of mercury)|Participants|Standard Error|Mean
782025|NCT00800683|Secondary|Clinically Relevant Drug-related Abnormalities for Blood Chemistry, Pulse Rate, Laboratory Parameters and ECG|Clinically relevant drug-related abnormalities for blood chemistry, pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as adverse events.|first administration of randomised treatment to ....|Clinically relevant drug-related abnormalities for blood chemistry, pulse rate, laboratory parameters and ECG||participants|||Number
782026|NCT00800683|Secondary|Change From Baseline in Antidiabetic Background Therapy Dose at 52 Weeks Compared to Baseline and Over Time|Number of patients with at least one change in daily dose, determined by at least a 10% increase in insulin.|Baseline and Week 52|Treated Set||Participants|||Number
782027|NCT00800683|Secondary|FPG Change From Baseline at week52|This change from baseline reflects the week 52 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs|Baseline and Week 52|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.||mg/dL||Standard Error|Least Squares Mean
782028|NCT00800683|Secondary|FPG Change From Baseline at Week 48|This change from baseline reflects the week 48 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs|Baseline and Week 48|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.||mg/dL||Standard Error|Least Squares Mean
782029|NCT00800683|Secondary|FPG Change From Baseline at Week 42|This change from baseline reflects the week 42 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs|Baseline and Week 42|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.||mg/dL||Standard Error|Least Squares Mean
782030|NCT00800683|Secondary|FPG Change From Baseline at Week 36|This change from baseline reflects the week 36 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs|Baseline and Week 36|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.||mg/dL||Standard Error|Least Squares Mean
782031|NCT00800683|Secondary|FPG Change From Baseline at Week 30|This change from baseline reflects the week 30 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs|Baseline and Week 30|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.||mg/dL||Standard Error|Least Squares Mean
782032|NCT00800683|Secondary|FPG Change From Baseline at Week 24|This change from baseline reflects the week 24 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs|Baseline and Week 24|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.||mg/dL||Standard Error|Least Squares Mean
782033|NCT00800683|Secondary|FPG Change From Baseline at Week 18|Model includes treatment, continuous baseline FPG , creatinine clearance , HbA1c and background of anti diabetic drugs|Baseline and Week 18|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.||mg/dL||Standard Error|Least Squares Mean
782034|NCT00800683|Secondary|FPG Change From Baseline at Week 12|This change from baseline reflects the week 12 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , creatinine clearance , HbA1c and background of anti diabetic drugs|Baseline and Week 12|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.||mg/dL||Standard Error|Least Squares Mean
782035|NCT00800683|Secondary|Percentage of Patients With HbA1c Lowering by 0.5% at Week 52|The percentage of patients with an HbA1c reduction from baseline >=0.5% at week 52 was calculated for each treatment arm. Non-completers were imputed as failure (NCF).|Baseline and Week 52|The Full Analysis Set (FAS) included all patients with a baseline and at least one on treatment HbA1c measurement available. Non-completers were considered as failure imputation (NCF).||Percentage of patients|||Number
782036|NCT00800683|Secondary|The Occurrence of a Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <7.0% After 52 Weeks of Treatment|The percentage of patients with an HbA1c value below 7.0% at week 52 was calculated for each treatment arm. Non-completers were imputed as failure (NCF). Analysis was only performed on patients with baseline HbA1c>=7%.|Baseline and Week 52|This population includes the FAS with baseline HbA1c>=7.0%. Non-completers were considered as failure imputation (NCF).||Percentage of patients|||Number
782037|NCT00800683|Secondary|The Occurrence of Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <6.5% After 52 Weeks of Treatment|The percentage of patients with an HbA1c value below 6.5% at week 52 was calculated for each treatment arm. Non-completers were imputed as failure (NCF). Analysis was only performed on patients with baseline HbA1c>=6.5%|Baseline and Week 52|This population includes the FAS with baseline HbA1c>=6.5%. Non-completers were considered as failure imputation (NCF).||Percentage of patients|||Number
782038|NCT00800683|Secondary|HbA1c Change From Baseline at Week 48|HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 48 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.|Baseline and Week 48|The Full Analysis Set (FAS) included all treated and randomised participants with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||Percent||Standard Error|Least Squares Mean
782039|NCT00800683|Secondary|HbA1c Change From Baseline at Week 42|HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 42 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.|Baseline and Week 42|The Full Analysis Set (FAS) included all treated and randomised participants with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||Percent||Standard Error|Least Squares Mean
782040|NCT00800683|Secondary|HbA1c Change From Baseline at Week 36|HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 36 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.|Baseline and Week 36|The Full Analysis Set (FAS) included all treated and randomised participants with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||Percent||Standard Error|Least Squares Mean
782721|NCT00807560|Primary|BMI Z Score|Z-score was calculated using the Baylor College of Medicine Children's Nutrition Research Center's online BMI calculator (https://www.bcm.edu/research/centers/childrens-nutrition-research-center/bodycomp/bmiz2.html).|baseline|||Z-score||Standard Deviation|Mean
782041|NCT00800683|Secondary|HbA1c Change From Baseline at Week 30|HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 30 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.|Baseline and Week 30|The Full Analysis Set (FAS) included all treated and randomised participants with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||Percent||Standard Error|Least Squares Mean
782042|NCT00800683|Secondary|HbA1c Change From Baseline at Week 24|HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.|Baseline and Week 24|The Full Analysis Set (FAS) included all treated and randomised participants with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||Percent||Standard Error|Least Squares Mean
782043|NCT00800683|Secondary|HbA1c Change From Baseline at Week 18|HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.|Baseline and Week 18|The Full Analysis Set (FAS) included all treated and randomised participants with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||Percent||Standard Error|Least Squares Mean
782044|NCT00800683|Secondary|HbA1c Change From Baseline at Week 52|HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 52 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.|Baseline and Week 52|The Full Analysis Set (FAS) included all treated and randomised participants with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||Percent||Standard Error|Least Squares Mean
782045|NCT00800683|Primary|HbA1c Change From Baseline at Week 12|HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline continuous HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.|Baseline and Week 12|The Full Analysis Set (FAS) included all treated and randomised participants with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||Percent||Standard Error|Least Squares Mean
782046|NCT00800735|Primary|Percentage of Participants Who Experienced at Least 1 Adverse Event.|An adverse event is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|Baseline through 24 weeks after the end of treatment (up to 72 weeks)|All enrolled patients.||Percentage of participants|||Number
782047|NCT00800839|Secondary|2-year Overall Survival|Overall Survival (OS) is defined as the interval between day of transplant and day of death.|First 25-35 days post transplant and then every 3 months for a maximum of 2 years|||percentage of participants||95% Confidence Interval|Number
782048|NCT00800839|Secondary|2-year Progression-Free Survival|Progression-free survival (PFS) is defined as the interval between day of transplant and day of death or disease progression.|First 25-35 days post transplant and then every 3 months for a maximum of 2 years|||percentage of participants||95% Confidence Interval|Number
782049|NCT00800839|Secondary|Rate of Engraftment|Engraftment defined as the evidence of donor derived cells (more than 5%) by bone marrow chimerism studies in the presence of neutrophil recovery by day 28 post stem cell (SC) infusion. Engraftment date is the first day of three (3) consecutive days that the ANC exceeds 0.5 x109/L. Delayed engraftment is defined as the evidence of engraftment beyond day 28 post SC infusion achieved after the administration of therapeutic (high dose) hematopoietic growth factors.|From engraftment to 60 days post transplant|||days||Full Range|Median
782050|NCT00800839|Primary|Day-100 Treatment-Related Mortality|Treatment-Related Mortality (TRM) was estimated from the date of transplant using the cumulative incidence method to account for competing risks. Disease progression or relapse death were considered competing risk for TRM.|100 days post transplant|||percentage of participants||95% Confidence Interval|Number
782051|NCT00800839|Primary|Cumulative Incidence of Grade III to IV Acute GVHD|Graft Versus Host Disease (GVHD) defined as grade 3 to 4 GVHD within first 100 days post transplant. Death or disease progression before diagnosis of GVHD were considered competing risks in the estimation of the incidence of acute GVHD.|100 days post transplant|||percentage of incidence||95% Confidence Interval|Number
782052|NCT00800839|Primary|Cumulative Incidence of Grade II to IV Acute GVHD|Graft Versus Host Disease (GVHD) defined as grade 2 to 4 GVHD within first 100 days post transplant. Death or disease progression before diagnosis of GVHD were considered competing risks in the estimation of the incidence of acute GVHD.|100 days post transplant|||percentage of incidence||95% Confidence Interval|Number
782053|NCT00800865|Primary|Ratio of pCDC2 Response in Skin Following Administration of Cytotoxic Therapy|Ratio of Phospho-CDC2 (pCDC2) response at 24, 32, and 48 hours compared to baseline, 24, and 32 hours post chemotherapy.|24, 32, and 48 hours post dose|||Ratio||90% Confidence Interval|Mean
782054|NCT00800865|Primary|Level of Biomarkers|Phospho-CDC2 (pCDC2) response in the skin following the administration of cytotoxic agents. pCDC2 levels were measured by immunohistochemistry (IHC).|Baseline, 24, 32, and 48 hours post dose|Actual number of participants analyzed in Part I varied from 13 to 15, depending on time point. Actual number of participants analyzed in Part II was 16 for all time points.||Percent pCDC2-positive cells||90% Confidence Interval|Geometric Mean
782081|NCT00810719|Secondary|Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 36 months|Two patients withdrew consent in the first cycle and were not evaluable for response.||percentage of participants|||Number
782055|NCT00800982|Primary|Psoriasis Area Severity Index. This Scale Ranges From 0-72, 0 Being no Disease, and 72 Being Most Severe. The Number of Patients Who Achieved 75% Improvement of Their Psoriasis at the End of 24 Weeks Are Indicated in the Outcomes Data Below.|Psoriasis area severity index was used to determine the number of patients in each treatment arm who had 75% improvement in their psoriasis. This scale uses the characteristics of the psoriasis, such as body surface area, redness, thickness, and scaling, to determine the severity score.|Weeks 12-24|All patients that completed the trial through week 24 were used for analysis.||participants|||Number
782056|NCT00801099|Secondary|Sustainability of the Intervention in This Setting||during 3 month of study phase||||||
782057|NCT00801099|Primary|Number of Participants With Surgical Site Infections||within 30 days postoperative|||participants|||Number
782058|NCT00801138|Secondary|Total Three-day Opioid Consumption in Oral Oxycodone Equivalent||Postoperative day 1, 2 and 3|||milligrams||Inter-Quartile Range|Median
782059|NCT00801138|Secondary|Median Maximum VAS Pain Scores at Rest|Visual Analogue Scale (VAS) pain scale is used to describe the severity or intensity of pain. It ranges from 0 to 10. Zero indicates“no pain at all” and ten indicates “worst pain imaginable.” , The higher of the score, the worse of the pain.|Postoperative day 1, 2 and 3|||units on a scale||Inter-Quartile Range|Median
782060|NCT00801138|Secondary|Time to First Report of Pain||Postoperative day 1, 2 and 3|||hours||Inter-Quartile Range|Median
782061|NCT00801138|Primary|The Duration of the Interscalene Nerve Block Which is Time to First Administration of Pain Medication After Block||Postoperative day 1, 2 and 3|||hours||Inter-Quartile Range|Median
782062|NCT00801229|Primary|"Participants Experiencing Collisions During Surprise Events in Driving Simulator"|"Initial results from a one hour driving simulation in the MIT AgeLab Driving Simulator as compared to second session in the simulator following a 6-week trial on Lisdexamfetamine or placebo. During the simulation, surprise events, designed to test the participant's attention and driving, occurred. This outcome presents the difference in number of collisions experience by individuals treated with Vyvanse or Placebo."|6 weeks|Participants who completed the protocol, including endpoint Driving Simulation assessment, were analyzed (61 in total).||participants|||Number
782063|NCT00801242|Secondary|Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables During One or More Cycles of Degarelix IAD Treatment|This outcome measure included incidence of markedly abnormal changes in safety laboratory values. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value during the trial. ULN=Upper limit of normal.|Up to 3 x 31 months|Safety Analysis Set.||participants|||Number
782064|NCT00801242|Secondary|Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight During One or More Cycles of Degarelix IAD Treatment|This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value during the trial.|Up to 3 x 31 months|Safety Analysis Set.||participants|||Number
782065|NCT00801242|Secondary|Sexual Function, as Assessed by the International Index of Erectile Function (IIEF) Scale, During the Induction Treatment and Off-treatment Periods During the First Cycle of IAD|The IIEF scale addresses the relevant domains of male sexual function (i.e. erectile function, orgasmic function, sexual desire, intercourse satisfaction and overall satisfaction). The IIEF scale is psychometrically sound, and has been linguistically validated in multiple languages. The IIEF scale demonstrates the sensitivity and specificity for detecting treatment-related changes in patients with erectile dysfunction. It consists of the following domains (number of items per domain; ranges from x to y: erectile function (6; 1-30), orgasmic function (2; 0-10), sexual desire (2; 2-10), intercourse satisfaction (3; 0-15) and overall satisfaction (2; 2-10). For all domains, a higher score represents a better sexual function.|Up to 31 months|FAS, Cycle 1.||units on a scale||Standard Deviation|Mean
782066|NCT00801242|Secondary|Quality of Life, as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Prostate Module (EORTC QLQ-PR25), During the Induction Treatment and Off-treatment Periods During the First Cycle of IAD|The EORTC QLQ-PR25 employs a modular approach towards assessing cancer patients´ health-related Quality of Life (QoL) and assesses urinary, bowel, and sexual symptoms and functioning, and the side-effects of hormonal treatment. It consists of 25 questions distributed on six domains (number of items per domain, ranges from x to y: urinary symptoms (8, 0-100), bother due to use of incontinence aid (1, 0-100), bowel symptoms (4, 0-100), hormonal treatment-related symptoms (6, 0-100), sexual activity (2, 0-100), and sexual functioning (4, 0-100). All raw domain scores are linearly transformed to a 0-100 scale, with higher scores reflecting either more symptoms (urinary, bowel, hormonal treatment-related symptoms) or higher levels of activity or functioning (sexual).|Up to 31 months|FAS, Cycle 1||units on a scale||Standard Deviation|Mean
782067|NCT00801242|Secondary|Number of Participants With Testosterone ≤0.5 ng/mL at the Last Visit of the Induction Period During the First Cycle of IAD||7 months|FAS, Cycle 1.||participants|||Number
782068|NCT00801242|Secondary|Median and Between Participant Variability of Time to Return to Testosterone >0.5 ng/mL (Above Castration Level) During the First Cycle of IAD After 7 Monthly Injections of Degarelix Induction Treatment|Blood samples for analyses of serum testosterone levels were collected at the Screening Visit, Month 4 and 7 of the induction period of Cycle 1 and the corresponding visits of any additional treatment cycles, every two months during the off-treatment period(s), and at the End-of-Trial Visit. Analyses were performed using Liquid-Liquid Extraction and Liquid Chromatography-Mass Spectrometry/Mass Spectrometry.|Up to 24 months after end of induction period|FAS, Off-treatment Cycle 1.||days||95% Confidence Interval|Median
782069|NCT00801242|Secondary|Percentage Change in PSA Serum Levels From Baseline to the Last Visit of the Induction Period During the First Cycle of IAD||7 months|FAS, Cycle 1.||percentage of baseline||Standard Deviation|Mean
782082|NCT00810719|Primary|Progression Free Survival|Defined as the time from first day of treatment to the first observation of disease progression or death due to any cause. If a patient has not progressed or died, progression-free survival is censored at the time of last follow-up. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Up to 36 months|||months||95% Confidence Interval|Median
782722|NCT00807560|Secondary|Height|This variable informs the calculation of the outcome variable of BMI Z score.|Baseline|||inches||Standard Deviation|Mean
782070|NCT00801242|Primary|Median and Between Participant Variability of Time to Prostate-specific Antigen (PSA) >4 ng/mL During the First Cycle of Intermittent Androgen Deprivation (IAD) After 7 Monthly Injections of Degarelix Induction Treatment|Blood samples for analyses of serum PSA levels were collected at the Screening Visit, and every two months during the course of the trial, and at the End-of-Trial Visit. Analyses were performed using chemiluminometric immunoassay.|Up to 24 months after end of induction period|FAS, Off-treatment Cycle 1, i.e. a subset of all FAS participants who completed the 7 months' induction treatment period of the first cycle and were enrolled in the off-treatment period (of the first cycle) and had at least one efficacy assessment (i.e. PSA or testosterone determination) during the off-treatment period.||days||95% Confidence Interval|Median
782071|NCT00810641|Primary|Treatment of Apogeotropic Horizontal Canal Benign Paroxysmal Positional Vertigo: A Randomized Clinical Trial|The immediate treatment response was determined by participating neurologists in each clinic without knowing the maneuver applied to each patient from 30 minutes to one hour after initial maneuver. The absence of both vertigo and nystagmus was required to determine a resolution.|one hour|Of the 157 patients enrolled in the study, three were lost for follow-up (dropout rate, 1.9%) and 154 were finally included for analyses.||participants||95% Confidence Interval|Number
782072|NCT00810693|Secondary|Living With Pulmonary Hypertension (LPH) Questionnaire - Change From Baseline to Week 12|The self-reported Living with Pulmonary Hypertension (LPH) questionnaire is designed to measure the effects of PH and PH-specific treatments on an individual’s quality of life. The LPH total score can range from 0 (best) to 105 (worst).|Baseline and week 12|Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered. Participants with a missing baseline were excluded from the analysis of the LPH questionnaire.||Scores on a scale||Standard Deviation|Mean
782073|NCT00810693|Secondary|EQ-5D Utility Score - Change From Baseline to Week 12|EQ-5D utility score is a Quality-of-Life participant reported outcome measure. The utility score is calculated based on five questions concerning problems with mobility, self-care, usual activities, pain/discomfort and anxiety/depression. An increase in the utility score represents an improvement in quality of life. The score ranges from -0.594 (worst answer in all five questions) to 1 (best answer in all five questions).|Baseline and week 12|Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered. Participants with a missing baseline were excluded from the analysis of the EQ5D utility score.||Scores on a scale||Standard Deviation|Mean
782074|NCT00810693|Secondary|Borg CR 10 Scale - Change From Baseline to Week 12|"The Borg CR10 Scale is a participant reported outcome measure used in clinical diagnosis of e.g. breathlessness and dyspnea. It documents the participant's exertion during a physical test. Low values indicate low levels of exertion; high values indicate more intense exertion reported by the participant. The score ranges from 0 (Nothing at all) to 10 (“Extremely strong – Maximal”)."|Baseline and week 12|Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered.||Scores on a scale||Standard Deviation|Mean
782075|NCT00810693|Secondary|Percentage of Participants With Clinical Worsening|The combined endpoint “time to clinical worsening”, made up of the following components, defined by the first occurrence: all-cause mortality; heart/lung transplantation; atrial septostomy; first hospitalization due to pulmonary hypertension; start of a new pulmonary hypertension treatment; persistent worsening of 6MWD or WHO functional class due to deterioration of PH .|At week 12|Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered.||Percentage of participants|||Number
782076|NCT00810693|Secondary|World Health Organization (WHO) Functional Class - Change From Baseline to Week 12|The WHO functional assessment of pulmonary arterial hypertension ranged from functional class I (participants with PH but without resulting limitation of physical activity) to class IV (participants with PH with inability to carry out any physical activity without symptoms. These participants manifest signs of right-heart failure.). Changes to a lower WHO functional class resemble improvement; changes to a higher functional class resemble deterioration of PAH.|Baseline and week 12|Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered. Participants with a missing baseline were excluded from the analysis of WHO functional class.||Percentage of participants|||Number
782077|NCT00810693|Secondary|N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) - Change From Baseline to Week 12|N-terminal pro-brain natriuretic peptide (NT-proBNP) levels in the blood are used for screening, diagnosis of acute congestive heart failure (CHF) and may be useful to establish prognosis in heart failure.|Baseline and week 12|Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one post-baseline measurement were included in the analysis of NT-proBNP.||pg/mL||Standard Deviation|Mean
782078|NCT00810693|Secondary|Pulmonary Vascular Resistance (PVR) - Change From Baseline to Week 12|The pulmonary vascular resistance (PVR) is a calculated hemodynamic parameter. PVR is derived from the directly measured parameters mean pulmonary arterial pressure (PAPmean) and pulmonary capillary wedge pressure (PCWP), divided by the cardiac output (CO). PVR and PAPmean are acquired during a right heart catheterization. CO is a calculated hemodynamic parameter, too. Formula: PVR = 80*(PAPmean - PCWP)/CO|Baseline and week 12|Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one post-baseline measurement were included in the analysis of PVR.||dyn*s*cm^-5||Standard Deviation|Mean
782079|NCT00810693|Primary|6 Minutes Walking Distance (6MWD) - Change From Baseline to Week 12|6-minute walking distance (6MWD) is a measure for the objective evaluation of a patient's functional exercise capacity.|Baseline and week 12|Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered.||Meters||Standard Deviation|Mean
782080|NCT00810719|Secondary|Overall Survival|Overall survival will be followed for survival every three months until documented progression, death or study termination. If a participant is still alive, survival time is censored at the time of last follow-up.|Up to 36 months|||months||95% Confidence Interval|Median
782083|NCT00810771|Secondary|If Colorectal Cancer Screening Screening (CRCS) Discussed With Provider.|"Outcome measure measuring percentage of participants discussing CRCS with provider using single question (yes/no): did you discuss Colorectal Cancer Screening with your provider?"|3-5 days after Decider Guider intervention.|Data was not collected for Usual Care arm.||percentage of participants|||Number
782086|NCT00810771|Secondary|Decisional Satisfaction|"Outcome measures measuring decisional satisfaction using 7-item scale categorized into low, moderate, high.
Decisional satisfaction is a measure that was first developed by Margaret Holmes Rover and colleagues (Med Decis Making. 1996 Jan-Mar;16(1):58-64) to assess the perspective of a patient involved in a medical decision with the decision making process. The measure includes questions related to overall satisfaction, and satisfaction with the amount of information received, involvement in, degree of consistency with values, and time to make the decision. The measure includes 5 questions each on a 5 point scale where higher scores = higher satisfaction. When scaled into one overall measure of decision satisfaction, lower scores = lower satisfaction and higher scores = higher satisfaction."|3-5 days after Decider Guider intervention.|Data was not collected for Usual Care arm.||Percentage of participants|||Number
782087|NCT00810771|Secondary|Colorectal Cancer Screening (CRCS) Knowledge and Attitudes.|Outcome measure measuring knowledge of CRCS using 8-item knowledge measure (all true/false questions) developed for study, scaled and categorized into low/moderate/high knowledge, where low = low knowledge and high = high knowledge.|3-5 days after Decider Guider intervention.|Data was not collected for Usual Care arm.||percentage of participants|||Number
782088|NCT00810771|Secondary|Number of Elements of Braddock's Informed Decision Making (IDM) Model Discussed With Provider|Outcome measure using 6 items measuring degree of participation in IDM. Scaled and recategorized into Low, Moderate and High level of IDM. The range is from 1 (low level of IDM) to 6 (high level of IDM).|3-5 days after Decider Guider intervention|Data was not collected for Usual Care arm.||Degree of participation||Full Range|Mean
782089|NCT00810771|Primary|Colorectal Cancer (CRC) Screening Rate.|The CRC Screening rate reports percentage of participant adherence with any Colorectal Cancer Screening test within 6 months of Decider Guider intervention. Decider Guider is a tool to help patients make an informed choice about colon cancer testing.|Within 6 months of Decider Guider intervention.|||percentage of participants|||Number
782090|NCT00810901|Secondary|Talked to Parents About Choice to be Organ Donor on License at 12 Months|Number of teens who talk had not talked to parents at baseline but reported they had talked to their parents about the choice to become an organ donor on their driver's license at 12 months|12 months|||participants||95% Confidence Interval|Number
782091|NCT00810901|Primary|Designated Organ Donor Status on Driver's License|Number of students who reported not being donor at baseline but were donor at 12 months follow-up|12 months|t-test||participants||95% Confidence Interval|Number
782092|NCT00811382|Secondary|Progression of AF and AT/AF Burden|The proportion of patients in sinus rhythm or with paroxysmal AF, persistant AF, or permanet AF at the end of the Follow-Up, without statistical evaluation and analysis of AF/AT (atrial tachycardia) burden based on the home monitoring data|12 months|Endpoint was not evaluated because of the insignificant result for the primary hypothesis and early study discontinuation due to low enrollment|||||
782093|NCT00811382|Secondary|Reverse Remodelling (LA Diameter, LVESV, Mitral Regurgitation)|Analysis of the change in left ventricular end-systolic volume, left atrial diameter, left ventricular EF, and the degree of mitral regurgitation from enrollment to the end of the follow-up in the two treatment arms|12 months|Endpoint was not evaluated because of the insignificant result for the primary hypothesis and early study discontinuation due to low enrollment|||||
782094|NCT00811382|Secondary|Heart Failure Clinical Composite Score (Packer Score)|Analysis of the fraction of patients with worsened composite clinical score in the two treatment arms.|12 months|Endpoint was not evaluated because of the insignificant result for the primary hypothesis and early study discontinuation due to low enrollment|||||
782095|NCT00811382|Primary|Days Lost|Clinical composite outcome based on the days lost due to cardiovascluar mortality, cardiovascular hospitalization and inappropriate ICD therapy during an observational period of 12 months.|12 months|||Days lost per patient||Standard Deviation|Mean
782096|NCT00811395|Secondary|Cerebral MRI Assessment: Total Volume of Gd-enhancing T1-lesions Per Scan|Total volume of Gd-enhancing T1-lesions per scan is obtained from the sum of the volumes of Gd-enhancing T1-lesions observed during the study divided by the total number of scans performed during the study.|48 weeks|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.||mililiters per scan|||Number
782097|NCT00811395|Primary|Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities [PCSA]|"PCSA values are abnormal values considered medically important by the Sponsor according to predefined criteria based on literature review.
Hepatic parameters thresholds were defined as follows:
Alanine Aminotransferase [ALT] >3, 5, 10 or 20 Upper Normal Limit [ULN];
Aspartate aminotransferase [AST] >3, 5, 10 or 20 ULN;
Alkaline Phosphatase >1.5 ULN;
Total Bilirubin [TB] >1.5 or 2 ULN;
ALT >3 ULN and TB >2 ULN;"|from first study drug intake in PDY6045/PDY6046 study up to 112 days after last intake in initial study or in the extension study, whichever occured last (64 weeks max)|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.||participants|||Number
782098|NCT00811395|Secondary|Cerebral MRI Assessment: Number of Gd-enhancing T1-lesions Per Scan (Poisson Regression Estimates)|"Number of Gd-enhancing T1-lesions per scan is obtained from the total number of Gd-enhancing T1-lesions observed during the study divided by the total number of scans performed during the study.
To account for the different number of scans among participants, two Poisson regression models with robust error variance were used (total number of Gd-enhancing T1-lesions as response variable, log-transformed number of scans as offset variable and:
Model 1 (IFN-β groups): Treatment group, region of enrollment, IFN-β dose level and baseline number of Gd-enhancing T1-lesions as covariates
Model 2 (GA groups): Treatment group, region of enrollment and baseline number of Gd-enhancing T1-lesions as covariates)"|48 weeks|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.||lesions per scan||95% Confidence Interval|Number
782112|NCT00811473|Secondary|Number of Patients Reaching Remission Where Remission is Defined as CDRS-R Total Score ≤28 at Final Assessment (Day 57).|The number of patients with remission from Days 8 to 57 was calculated. The CDRS-R is a 17-item scale with 3 items scored from 1-5 and 14 items scored from 1-7, where higher scores indicating more severe depression. The 17 item scores are summed to give the total score (total score range 17-113).|Days 8 to 57|||participants|||Number
782723|NCT00807560|Secondary|Hip Measurement|Hip measurement in inches. This is not a primary outcome variable.|up to 44 weeks|||inches||Standard Deviation|Mean
782724|NCT00807560|Secondary|Hip Measurement|Hip measurement in inches. This is not a primary outcome variable.|baseline|||inches||Standard Deviation|Mean
782099|NCT00811395|Secondary|Cerebral Magnetic Resonance Imaging [MRI] Assessment: Change From Baseline in Total Lesion Volume (Burden of Disease)|"Total lesion volume is the sum of the total volume of all T2-lesions and the total volume all T1-hypointense post-gadolinium lesions measured through T2/proton density scan analysis and gadolinium-enhanced T1 scan analysis.
Least-square means were estimated using two Mixed-effect models with repeated measures [MMRM] on cubic root transformed volume data:
Model 1 (IFN-β groups): treatment group, region of enrollment, IFN-β dose level, visit, treatment-by-visit interaction, baseline value (cubic root transformed), and baseline-by-visit interaction as factors;
Model 2 (GA groups): treatment group, region of enrollment, visit, treatment-by-visit interaction, baseline value (cubic root transformed), and baseline-by-visit interaction as factors."|baseline (before randomization in PDY6045 or PDY6046) and 48 weeks|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.||mililiters (mL)||Standard Error|Least Squares Mean
782100|NCT00811395|Secondary|Time to 12-week Sustained Disability Progression: Kaplan-Meier Estimates of the Rate of Disability Progression at Timepoints|"Probability of disability progression at 24 and 48 weeks was estimated using Kaplan-Meier method on the time to disability progression defined as the time from randomization to first EDSS increase. Participants free of disability progression were censored at the date of the last on-treatment EDSS evaluation.
Kaplan-Meier method consists in computing probabilities of non occurrence of event at any observed time of event and multiplying successive probabilities for time ≤t by any earlier computed probabilities to estimate the probability of being event-free for the amount of time t. Probability of event at time t is 1 minus the probability of being event-free for the amount of time t."|48 weeks|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.||percent probability||95% Confidence Interval|Number
782101|NCT00811395|Secondary|Overview of 12-week Sustained Disability Progression|"12-week sustained disability progression was defined as an increase from baseline of at least 1-point in EDSS score (at least 0.5-point for participants with baseline EDSS score >5.5) that persisted for at least 12 weeks.
If no disability progression was observed on or before last EDSS evaluation before study drug discontinuation, then the participant was considered as free of disability progression."|48 weeks|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.||participants|||Number
782102|NCT00811395|Primary|Overview of AE With Potential Risk of Occurence|"AE with potential risk of occurrence were defined as follows:
Hepatic disorders;
Immune effects, mainly effects on bone marrow and infection;
Pancreatic disorders;
Malignancy;
Skin disorders, mainly hair loss and hair thinning;
Pulmonary disorders;
Hypertension;
Peripheral neuropathy;
Psychiatric disorders;
Hypersensitivity."|from first study drug intake in PDY6045/PDY6046 study up to 112 days after last intake in initial study or in the extension study, whichever occured last (64 weeks max)|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.||participants|||Number
782103|NCT00811395|Secondary|Annualized Relapse Rate [ARR]: Poisson Regression Estimates|"ARR is obtained from the total number of confirmed relapses that occured during the treatment period divided by the sum of the treatment durations.
Each episode of relapse - appearance, or worsening of a clinical symptom that was stable for at least 30 days, that persisted for a minimum of 24 hours in the absence of fever - was to be confirmed by an increase in Expanded Disability Status Scale [EDSS] score or Functional System scores.
To account for the different treatment durations among participants, two Poisson regression models with robust error variance were used (total number of confirmed relapses as response variable, log-transformed treatment duration as offset variable and:
Model 1 (IFN-β groups): treatment group, region of enrollment and IFN-β dose level as covariates
Model 2 (GA groups): treatment group and region of enrollment as covariates)"|48 weeks|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.||relapses per year||95% Confidence Interval|Number
782104|NCT00811395|Primary|Overview of Adverse Events [AE]|AE are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.|from first study drug intake in PDY6045/PDY6046 study up to 112 days after last intake in initial study or in the extension study, whichever occured last (64 weeks max)|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.||participants|||Number
782105|NCT00811434|Secondary|Effeccts of Lactulose Treatment on MHE as Measaured by Cognitive Function|MHE as measured by failure of one or more cognitive test|before and after each treatment period|data not collected as planned|||||
782106|NCT00811434|Secondary|Health Related Quality of Life (HRQOL)|HRQOL administered to parents prior to treatment|baseline|data not collected as planned|||||
782107|NCT00811434|Primary|Incidence of Minimal Hepatic Encephalopathy (MHE) in Children With Cirrhosis|failure of one cognitive function test indicates presence of MHE|baseline|||participant|||Number
782108|NCT00811473|Secondary|The Proportion of Patients at Final Assessment (Day 57) With Improvement of Overall Bipolar Illness|The proportion of patients with improvement of overall bipolar illness at Day 57 was calculated. Improvement defined as a CGI-BP-C of “Much” or “Very much” improved in overall bipolar illness assessment.|Day 57|||Proportions|||Number
782109|NCT00811473|Secondary|CGI-BP-C Score at Final Assessment (Day 57)|The CGI-BP-C scale rates how much the patient’s illness has improved or worsened compared to the phase immediately preceding treatment and is scored on a scale from 1 to 8 (1=very much improved to 7=very much worse; 8=not applicable). CGI-BP-C scores >4 indicate worsening, while scores <4 indicate improvement.|Change from Baseline to day 57|||Scores on a scale||Standard Error|Least Squares Mean
782110|NCT00811473|Secondary|Change From Baseline to Final Assessment (Day 57) in the CGI-BP-S|The CGI-BP-S scale rates the severity of the patient’s illness at the time of assessment and is scored from 1 to 7 (1=normal, not ill to 7=very severely ill). Higher CGI-BP-S scores indicate greater illness severity.|Change from Baseline to Day 57|||Scores on a Scale||Standard Error|Least Squares Mean
782111|NCT00811473|Secondary|The Number of Patients With the Response, Where Response is Defined as ≥50% Reduction From Baseline to Final Assessment (Day 57) in CDRS-R Total Score|The number of patients reaching response from Days 8 to 57 was calculated. The CDRS-R is a 17-item scale with 3 items scored from 1-5 and 14 items scored from 1-7, where higher scores indicating more severe depression. The 17 item scores are summed to give the total score (total score range 17-113).|Days 8 to 57|||participants|||Number
782113|NCT00811473|Primary|Change in the Children Depression Rating Scale, Revised (CDRS-R) Total Score From Baseline to Final Assessment (Day 57)|Severity of depression in children and adolescents was calculated based on the 17-item CDRS-R scale (3 items scored from 1-5 and 14 items scored from 1-7, with higher scores indicating more severe depression). The 17 item scores are summed to give the total score (total score range 17-113).|Will be scored at all visits. the analysis is the change from baseline to the final assessment at day 57|||Scores on a scale||Standard Error|Least Squares Mean
782114|NCT00811564|Primary|Intraocular Pressure (IOP) at Week 12|Mean IOP at week 12. IOP is a measurement of the fluid pressure inside the eye.|Week 12|Intent-to-treat, which included all patients who started the study (randomized).||Millimeters of mercury (mm Hg)||Standard Deviation|Mean
782115|NCT00811577|Secondary|Histological Evaluation of Number of Alpha Smooth Muscle Actin Cells|Three trocar sites designated as anterior, lateral and posterior were randomized on each patient to receive AZX100 3 mg/cm or AZX100 10 mg/cm or placebo/cm at 9 days and 21 days following shoulder surgery. A skin punch biopsy was taken of each trocar site at 12 months. For exploratory purposes, the specimens were blindly scored in duplicate by a dermal pathologist for the estimated number of alpha-smooth muscle actin (α-SMA) positive cells per high powered field. Values ranged from 0 to several hundred. The number of α-SMA cells was assessed for exploratory purposes; therefore, at the time of this report, it was not known whether it was better to have a low or high α-SMA score.|12 months|This analysis was based on patient data from the AZX100/Placebo cohort (i.e., not including patients receiving placebo-only). In the ITT sample for the histology analyses, available sample sizes were 122 at Day 42 and 113 at Month 12 (including four subjects who withdrew from the study but were still followed for safety until Month 12).||Cells per high-powered field||Standard Deviation|Mean
782116|NCT00811577|Secondary|Histological Evaluation of Collagen|Three trocar sites designated as anterior, lateral and posterior were randomized on each patient to receive AZX100 3 mg/cm or AZX100 10 mg/cm or placebo/cm at 9 days and 21 days following shoulder surgery. A skin punch biopsy was taken of each trocar site at 12 months. The specimens were blindly scored in duplicate by a dermal pathologist for dermal collagen fiber density, maturity and orientation, where 0% was completely normal and 100% was completely abnormal.|12 months|This analysis was based on patient data from the AZX100/Placebo cohort (i.e., not including patients receiving placebo-only). In the ITT sample for the histology analyses, available sample sizes were 122 at Day 42 and 113 at Month 12 (including four subjects who withdrew from the study but were still followed for safety until Month 12).||Percent||Standard Deviation|Mean
782117|NCT00811577|Secondary|Between-group Mean Differences in Objective Measures Via 3D Photography (Volume)|Three trocar sites designated as anterior, lateral and posterior were randomized on each patient to receive AZX100 3 mg/cm, or AZX100 10 mg/cm, or placebo/cm at 9 days and 21 days following shoulder surgery. 3D digital photography of each trocar scar was used to calculate positive volume, negative volume, and total volume in millimeters cubed (mm^3) at 12 months. Positive volume included the scar volume that was calculated to be above the interpolated smooth skin surface. A smaller value was preferred. Negative volume included the volume of the scar calculated to be below the interpolated smooth skin surface. It was always a negative number; negative values (closer to zero) were more desirable. Total volume was calculated as the sum of positive volume and the absolute value of negative volume. Smaller values were more desirable.|12 months|Efficacy analysis was based on patient data from the AZX100/Placebo cohort (i.e., not including patients receiving placebo-only). In the ITT sample for the scar objective measures, available sample sizes were 122 at Day 42 and 113 at Month 12 (including four subjects who withdrew from the study but were still followed for safety until Month 12).||Millimeters cubed||Standard Deviation|Mean
782118|NCT00811577|Secondary|Between-group Mean Differences in Objective Measures Via 3D Photography (Elevation, Length, Width)|Three trocar sites designated as anterior, lateral and posterior were randomized on each patient to receive AZX100 3 mg/cm or AZX100 10 mg/cm or placebo/cm at 9 days and 21 days following shoulder surgery. 3D digital photography of each trocar scar was used to calculate scar length, width, minimum elevation, and maximum elevation in millimeters (mm) at 12 months. The minimum elevation value was calculated as the lowest point of the scar below the interpolated smooth skin surface. This was always a negative number. Negative values (closer to zero) were more desirable. The maximum elevation value was the highest point of the scar above the interpolated smooth skin surface. A smaller value was preferred.|12 months|Efficacy analysis was based on patient data from the AZX100/Placebo cohort (i.e., not including patients receiving placebo-only). In the ITT sample for the scar objective measures, available sample sizes were 122 at Day 42 and 113 at Month 12 (including four subjects who withdrew from the study but were still followed for safety until Month 12).||Millimeters||Standard Deviation|Mean
782119|NCT00811577|Secondary|Between-group Mean Differences in Visual Analog Scale Scores Rated by Independent Blinded Raters Using 3D Photography|Three trocar sites were randomized on each patient to receive AZX100 3 mg/cm or AZX100 10 mg/cm or saline placebo/cm at 9 days and 21 days after surgery. Twelve months after surgery, images of the trocar sites were longitudinally evaluated and rated using a standard 100 mm Visual Analog Scale (VAS) by two blinded independent dermatologists, with 0 being normal skin and 100 being the worst scar imaginable. Efficacy was based on the difference between VAS scores of placebo and 3 mg AZX100 and placebo and 10 mg AZX100 for each of the two raters separately. Data from both raters was not combined.|12 months|Efficacy analysis was based on patient data from the AZX100/Placebo cohort (i.e., not including patients receiving placebo-only). In the ITT sample for the VAS outcome, available sample sizes were 122 at Day 42 and 113 at Month 12 (including four subjects who withdrew from the study but were still followed for safety until Month 12).||Millimeters||Standard Deviation|Mean
782128|NCT00811642|Secondary|Number of Participants Who Had Clinical Response at 4 Weeks With Posaconazole Treatment|"EVALUATION OF PARTICIPANTS' CLINICAL RESPONSE BASED ON CRITERIA:
Complete Response: resolution of IFI attributable symptoms, signs and laboratory or etiological abnormalities, if present at enrollment.
Partial Response: clinically significant improvement in IFI attributable symptoms, signs and laboratory or etiological abnormalities, if present at enrollment, of which, one still had not achieved complete recession.
Stable disease: no progress in IFI attributable symptoms, if present at enrollment.
Failure: deterioration in IFI attributable clinical symptoms."|Treatment week 4|Pool of participants were from the FAS: included all randomized participants who received at least one dose of study drug and who had valid data of primary efficacy endpoint for at least one follow-up visit after treatment. Did not include the 3 participants from the SS population (n=62) who withdrew from the study.||Particpants|||Number
782120|NCT00811577|Primary|Differences Among the 3 Dosage Groups in the Patient (PSAS) and Observer (OSAS) Scar Assessment Scale (POSAS) Scores|Efficacy was based on the difference between mean POSAS scores of placebo and 3 mg AZX100, and placebo and 10 mg AZX100 12 months after shoulder surgery. Three trocar sites were randomized on each patient to receive AZX100 3 mg or AZX100 10 mg or placebo at 9 days and 21 days after shoulder surgery. PSAS results included patients' ratings on a scale of 1-10 (1 was normal skin or no complaints and 10 was the worst imaginable scar or the worst difference) for the following: Is the scar painful? Is the scar itching? Is the color of the scar different? Is the scar more stiff? Is the thickness of the scar different? Is the scar irregular? The possible minimum score was 6 and the maximum (worst) score was 60. OSAS results included observers' ratings on a scale of 1-10 (1 was normal skin and 10 was the worst scar imaginable) for vascularization, pigmentation, thickness, relief, and pliability. The possible minimum score was 5 and the possible maximum (worst) score was 50.|12 months|The efficacy analysis was based on patient data from the AZX100/Placebo cohort (i.e., not including the patients receiving placebo-only). In the ITT sample for the POSAS outcomes, available sample sizes were 122 at Day 42 and 113 at Month 12 (including 4 subjects who withdrew from the study but were still followed for safety until Month 12).||Units on a scale||Standard Deviation|Mean
782121|NCT00811590|Primary|The Size of Intestinal Polyps||24 months|Due to small enrollment number, analysis was not possible.|||||
782122|NCT00811642|Primary|Number of Participants Who Had Clinical Response at 12 Weeks With Posaconazole Treatment|"EVALUATION OF PARTICIPANTS' CLINICAL RESPONSE BASED ON CRITERIA:
Complete Response: resolution of Invasive Fungal Infection (IFI) attributable symptoms, signs and laboratory or etiological abnormalities, if present at enrollment.
Partial Response: clinically significant improvement in IFI attributable symptoms, signs and laboratory or etiological abnormalities, if present at enrollment, of which, one still had not achieved complete recession.
Stable disease: no progress in IFI attributable symptoms, if present at enrollment.
Failure: deterioration in IFI attributable clinical symptoms."|Treatment week 12|Pool of participants were from the Full Analysis Set (FAS): included all randomized participants who received at least one dose of study drug and who had valid data of primary efficacy endpoint for at least one follow-up visit after treatment. Did not include the 3 participants from the SS population (n=62) who withdrew from the study.||Participants|||Number
782123|NCT00811642|Secondary|Number of Participant Survivors at Week 14 of Post-Posaconazole Treatment Follow-up|Total number of participant deaths was assessed at the end of 2 week post-treatment follow-up (14 weeks). The total number of deaths was compared to the number of survivors at baseline.|Follow-up week 14|Pool of participants were from the FAS: included all randomized participants who received at least one dose of study drug and who had valid data of primary efficacy endpoint for at least one follow-up visit after treatment. Did not include the 3 participants from the SS population (n=62) who withdrew from the study.||Participants|||Number
782124|NCT00811642|Secondary|Number of Participants With Pathogenic Fungal Eradication at 12 Weeks With Posaconazole Treatment|"EVALUATION OF FUNGAL ERADICATION:
Participants' mycological response to therapy was assessed by the following:
Eradication: Negative culture or histologically documented absence of infecting
fungal pathogen from a primary site previously positive.
Presumed Eradication: Resolution of all IFI attributable symptoms, signs and laboratory or radiological abnormalities in which a repeat culture/biopsy was contraindicated.
Persistence: Continued isolation of fungal pathogen from a primary site previously positive or cytological documentation of presence of fungal pathogen."|Treatment week 12|Only FAS participants with positive fungal culture (of suspected site or blood) were evaluated. LOCF was used for missing data.||Participants|||Number
782125|NCT00811642|Secondary|Number of Participants With Pathogenic Fungal Eradication at 8 Weeks With Posaconazole Treatment|"EVALUATION OF FUNGAL ERADICATION:
Participants' mycological response to therapy was assessed by the following:
Eradication: Negative culture or histologically documented absence of infecting
fungal pathogen from a primary site previously positive.
Presumed Eradication: Resolution of all IFI attributable symptoms, signs and laboratory or radiological abnormalities in which a repeat culture/biopsy was contraindicated.
Persistence: Continued isolation of fungal pathogen from a primary site previously positive or cytological documentation of presence of fungal pathogen."|Treatment week 8|Only FAS participants with positive fungal culture (of suspected site or blood) were evaluated. LOCF was used for missing data.||Participants|||Number
782126|NCT00811642|Secondary|Number of Participants With Pathogenic Fungal Eradication at 4 Weeks With Posaconazole Treatment|"EVALUATION OF FUNGAL ERADICATION:
Participants' mycological response to therapy was assessed by the following:
Eradication: Negative culture or histologically documented absence of infecting
fungal pathogen from a primary site previously positive.
Presumed Eradication: Resolution of all IFI attributable symptoms, signs and laboratory or radiological abnormalities in which a repeat culture/biopsy was contraindicated.
Persistence: Continued isolation of fungal pathogen from a primary site previously positive or cytological documentation of presence of fungal pathogen."|Treatment week 4|Only FAS participants with positive fungal culture (of suspected site or blood) were evaluated. Last Observation Carried Forward (LOCF) was used for missing data.||Participants|||Number
782127|NCT00811642|Secondary|Number of Participants Who Had Clinical Response at 8 Weeks With Posaconazole Treatment|"EVALUATION OF PARTICIPANTS' CLINICAL RESPONSE BASED ON CRITERIA:
Complete Response: resolution of IFI attributable symptoms, signs and laboratory or etiological abnormalities, if present at enrollment.
Partial Response: clinically significant improvement in IFI attributable symptoms, signs and laboratory or etiological abnormalities, if present at enrollment, of which, one still had not achieved complete recession.
Stable disease: no progress in IFI attributable symptoms, if present at enrollment.
Failure: deterioration in IFI attributable clinical symptoms."|Treatment week 8|Pool of participants were from the FAS: included all randomized participants who received at least one dose of study drug and who had valid data of primary efficacy endpoint for at least one follow-up visit after treatment. Did not include the 3 participants from the SS population (n=62) who withdrew from the study.||Participants|||Number
782129|NCT00811655|Secondary|Overall Survival (OS)|Time in months from the date of stereotactic radiosurgery (SRS) to the date of death due to any cause. Patients alive as of the last follow-up had OS censored at the last follow-up date. Median OS was estimated using a Kaplan-Meier curve.|24 months after SRS|Intent-to-treat||Months||95% Confidence Interval|Median
782130|NCT00811655|Secondary|Number of Patients Who Died Due to Neurological Causes|Number of patients who died due to neurological causes defined as death attributable to the progression of neurological disease.|Within 24 months post-SRS|Intent-to-treat||participants|||Number
782131|NCT00811655|Secondary|Clinical Significance of Locally Recurrent Brain Metastases|Number of patients with clinical significance (mass effect, cognitive functioning, and other symptoms) of locally recurrent brain metastases at the time of their occurrence.|24 months post-SRS|There are no patients for this analysis because none had a local recurrence.|||||
782132|NCT00811655|Secondary|Preservation of Neurocognitive Functioning as Measure by the Mini-Mental State Exam (MMSE)|Cognition as measured by the change in the Mini-Mental State Exam (MMSE) scores from baseline. The MMSE is an 11-item measure that tests five areas of cognitive function: orientation, registration, attention and calculation, recall and language. The maximum score is 30. Change score = score post-SRS minus the score at baseline. Positive change scores indicate improved cognition.|Administered at baseline and every 3 months post-SRS|Data for this outcome was erroneously not gathered.|||||
782133|NCT00811655|Secondary|Quality of Life After Stereotactic Radiosurgery (SRS) as Measured by the Functional Assessment of Cancer Therapy-Brain (FACT-Br)|Quality of life as measured by the change in FACT-Br scores from baseline. The FACT-Br (version 4) is comprised of the Functional Assessment of Cancer Therapy-General (FACT-G), a 27-item core questionnaire evaluating the domains of physical, family/social, emotional and functional well-being, with the addition of 23 brain cancer specific questions. The FACT-G total score is the sum of the four FACT-G domain scores. The Brain Cancer Subscale (BrCS) is the sum of 19 brain cancer specific questions. The FACT-Br Trial Outcome Index (TOI) is the sum of the BrCS score and the physical and family/social domain scores. The FACT-Br total score is the sum of the FACT-G total score and the BrCS score. Change score = score post-SRS minus the score at baseline. Positive change scores indicate improved quality of life.|Administered at baseline and every 3 months post-SRS|Data for this outcome was erroneously not gathered.|||||
782134|NCT00811655|Secondary|Number of Patients With New Brain Metastases Outside of the Pre-operative Stereotactic Radiosurgery (SRS) Site|Number of patients with new brain metastases outside of the pre-operative stereotactic radiosurgery (SRS) site.|Within 24 months post-SRS|Intent-to-treat; 1 patient was not included in this analysis as they were unable to undergo surgery after SRS.||participants|||Number
782135|NCT00811655|Secondary|Volume of Adjacent Normal Brain Parenchyma Irradiated|Volume of adjacent normal brain parenchyma irradiated during stereotactic radiosurgery (SRS).|At time of SRS|Data for this outcome was not collected.|||||
782136|NCT00811655|Secondary|Number of Patients Receiving Salvage Whole-brain Radiotherapy, Stereotactic Radiosurgery (SRS), or Surgery|Number of patients receiving salvage whole-brain radiotherapy, stereotactic radiosurgery (SRS), or surgery|Within 24 months post-SRS|Intent-to-treat; 1 patient was not included in this analysis as they were unable to undergo surgery after SRS.||participants|||Number
782137|NCT00811655|Primary|Number of Patients With Local Recurrence at the Surgical Site Within 12 Months After Stereotactic Radiosurgery (SRS)|Number of patients with local recurrence at the surgical site within 12 months after stereotactic radiosurgery (SRS) as measured by magnetic resonance imaging (MRI). To determine local recurrence, we evaluated follow-up MRI’s for reappearance of a lesion in exactly the same site in the brain as the first lesion(s).|Within 12 months after SRS|Intent-to-treat; 1 patient was not included in this analysis as they were unable to undergo surgery after SRS.||Participants|||Number
782138|NCT00811720|Secondary|Liver Function Test Alanine Aminotransferase (ALAT)|ALAT values|Week 24|FAS||IU/L||Geometric Coefficient of Variation|Geometric Mean
782139|NCT00811720|Secondary|Liver Function Test Gamma-glutamyl Transferase (GGT)|GGT values|Week 24|FAS||IU/L||Geometric Coefficient of Variation|Geometric Mean
782140|NCT00811720|Secondary|Change in Clinical Status Using the CGI-I|The Clinical Global Impression - Global Improvement (CGI-I) provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).|Week 24|FAS||units on a scale||Standard Error|Mean
782141|NCT00811720|Secondary|Change From Baseline in Clinical Status Using CGI-S|The Clinical Global Impression - Severity of Illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients).|Baseline and Week 24|FAS||units on a scale||Standard Error|Mean
782142|NCT00811720|Secondary|Drinking Risk Level (RSDRL) Response|RSDRL response was defined as a downward shift from baseline in Drinking Risk Level (DRL); for patients at very high risk at Baseline: a shift to medium risk or below, and for patients at high or medium risk at Baseline: a shift to low risk or below.|Month 6|FAS||percentage of participants|||Number
782143|NCT00811720|Primary|Change From Baseline in the Monthly Total Alcohol Consumption (TAC)|TAC was defined as mean daily alcohol consumption in g/day over a month (28 days).|Baseline and Month 6|FAS||g||Standard Error|Mean
782144|NCT00811720|Primary|Change From Baseline in the Monthly Number of Heavy Drinking Days (HDDs)|Number of HDDs over a month (28 days), where one HDD was defined as a day with alcohol consumption ≥60 grams (g) for men and ≥40 g for women.|Baseline and Month 6|Full-analysis set (FAS) – all patients in the all-patients-treated set (APTS) who had at least one valid post-baseline assessment in the main treatment period of both co-primary efficacy variables (HDD and TAC) and had an average alcohol consumption at medium Drinking Risk Level (DRL) or above according to WHO criteria at Baseline.||days||Standard Error|Mean
782145|NCT00811733|Secondary|Number of Participants With the Indicated Infusion-related >=Grade 3 AE|Infusion-related AEs are the AEs that resulted from administration of study drug through infusion. AEs were graded using the Common Toxicity Criteria for AEs from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No AE or within normal limits; 1 = Mild AE; 2 = Moderate AE; 3 = Severe and undesirable AE; 4 = Life-threatening or disabling AE; 5 = Death related to AE.|From baseline up to approximately 5 years|Safety Population. Only those participants who experienced >=Grade 3 infusion-related AEs were assessed.||participants|||Number
782146|NCT00811733|Secondary|Number of Participants With the Indicated >=Grade 3 AEs|AEs were graded using the Common Toxicity Criteria for AEs from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No AE or within normal limits; 1 = Mild AE; 2 = Moderate AE; 3 = Severe and undesirable AE; 4 = Life-threatening or disabling AE; 5 = Death related to AE.|From baseline up to approximately 5 years|Safety Population. Only those participants who experienced a >=Grade 3 AE were assessed.||participants|||Number
782147|NCT00811733|Secondary|Number of Participants With the Indicated AEs Leading to Permanent Discontinuation of Study Drug and Withdrawal From Study|Certain AEs led to permanent discontinuation of study drug and hence resulted in their withdrawal from the study.|From baseline up to approximately 5 years|Safety Population. Only those participants who experienced an AE leading to their withdrawal from the study were assessed.||participants|||Number
782148|NCT00811733|Secondary|Number of Participants With the Indicated SAEs and Non-serious AEs Related to Study Drug|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The Investigator assessed whether the AE was possibly or probably related to study drug.|From baseline up to approximately 5 years|Safety Population. Only those participants who experienced a study drug-related AE were assessed.||participants|||Number
782149|NCT00811733|Secondary|Number of Participants With the Indicated SAEs Related to Study Drug|An SAE is any event occurring at any dose that results in any of the following: death, a life-threatening adverse drug experience (ADE; at immediate risk of death from the experience as it occurred), inpatient hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, or a congenital anomaly/birth defect. Medical events that may not result in death, be life threatening, or require hospitalization may be considered to be a serious ADEs when based upon appropriate medical judgment. Relatedness was based on the Investigator's medical judgement.|From baseline up to approximately 5 years|Safety Population. Only those participants who experienced an SAE categorized as being related to study drug were assessed.||participants|||Number
782150|NCT00811733|Secondary|Change From Baseline in Blood Counts (CD4+, CD19+, CD50) at Month 3 After Treatment|CD4+ and CD19+ are two key flow cytometry parameters, and total hemolytic complement (CD50) is a complement parameter. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Month 3|ITT Population: only participants with blood count data at both Baseline and Month 3 were included in the analysis.||cells per microliter (µL)||Full Range|Median
782151|NCT00811733|Secondary|Number of Participants With at Least One Confirmed Positive Post-ofatumumab HAHA Result|All human-antihuman antibody (HAHA) samples were first tested in a screening assay to identify potential HAHA positives. Next, samples that tested positive in the screening assay were further tested in the confirmation assay to determine the specificity of the signal to ofatumumab. Confirmed positive samples were reported as positive.|From baseline up to approximately 5 years|Safety Population. Only those participants with post-ofatumumab HAHA results were analyzed.||participants|||Number
782152|NCT00811733|Secondary|AUC(0-tau) and AUC(0-inf) of Ofatumumab|AUC(0-tau) is the area under the drug concentration-time curve over the dosing interval (one week). AUC(0-inf) is the area under the drug concentration-time curve from time zero extrapolated to infinite time. Blood samples for the quantification of ofatumumab were collected during each cycle and for up to 6 months after the end of each cycle.|From the first dose (Cycle 1 Day 1) up to 6 months after the end of the last cycle of treatment; blood collected on each dosing day, weekly up to Week 8, and every 4 weeks up to Week 24/Month 7|PK Population. Data were provided for the number of participants attending each visit for whom the parameter could be calculated..||micrograms X hours/milliliters (µg.h/mL)||95% Confidence Interval|Geometric Mean
782153|NCT00811733|Secondary|Cmax and Ctrough of Ofatumumab|Cmax is defined as the maximum observed drug concentration after administration, and Ctrough is defined as the drug concentration observed prior to the start of the next dose. Blood samples for the quantification of ofatumumab were collected during each cycle and for up to 6 months after the end of each cycle.|From the first dose (Cycle 1 Day 1) up to 6 months after the end of the last cycle of treatment; blood collected on each dosing day, weekly up to Week 8, and every 4 weeks up to Week 24/Month 7|PK Population. Data were provided for the number of participants attending each visit for whom the parameter could be determined.||micrograms/milliliter (µg/ml)||95% Confidence Interval|Geometric Mean
782154|NCT00811733|Secondary|Half-life of Ofatumumab|Half-life (t½) is defined as the time required for the concentration of the drug in plasma to decrease to one-half of its current value. Blood samples for the quantification of ofatumumab were collected during each cycle and for up to 6 months after the end of each cycle.|From the first dose (Cycle 1 Day 1) up to 6 months after the end of the last cycle of treatment; blood collected on each dosing day, weekly up to Week 8, and every 4 weeks up to Week 24/Month 7|PK Population. Data were provided for the number of participants for whom the parameter could be determined.||Days (d)||95% Confidence Interval|Geometric Mean
782155|NCT00811733|Secondary|Volume of Distribution at Steady State of Ofatumumab|Volume of distribution at steady state (Vss) is defined as the apparent volume of distribution of the drug in the body at steady state. Blood samples for the quantification of ofatumumab were collected during each cycle and for up to 6 months after the end of each cycle.|From the first dose (Cycle 1 Day 1) up to 6 months after the end of the last cycle of treatment; blood collected on each dosing day, weekly up to Week 8, and every 4 weeks up to Week 24/Month 7|PK Population. Data were provided for the number of participants for whom the parameter could be determined.||Liters (L)||95% Confidence Interval|Geometric Mean
782156|NCT00811733|Secondary|Clearance of Ofatumumab|Clearance (CL) is defined as the volume of plasma that is cleared of drug per unit of time. Blood samples for the quantification of ofatumumab were collected during each cycle and for up to 6 months after the end of each cycle.|From the first dose (Cycle 1 Day 1) up to 6 months after the end of the last cycle of treatment; blood collected on each dosing day, weekly up to Week 8, and every 4 weeks up to Week 24/Month 7|Pharmacokinetic (PK) Population: all participants from whom a PK sample was obtained and analyzed. Data were provided for the number of participants for whom the parameter could be determined.||milliliters/hour (ml/hr)||95% Confidence Interval|Geometric Mean
782157|NCT00811733|Secondary|Overall Survival|Overall survival is defined as the time from baseline until death due to any cause.|From baseline up to approximately 5 years|ITT Population. Only those participants who died during the study and during the follow-up period were assessed.|||||
782158|NCT00811733|Secondary|Time to Response for Responders|Time to response is defined as the time from baseline to the first response date.|From baseline up to approximately 5 years|ITT Population. Only participants classified as responders (CR, PR, and MR) were assessed.||days||95% Confidence Interval|Median
782198|NCT00811954|Secondary|Self-reported Adherence|Self-reported percentage of anti-HIV medications participant had taken during the last month at weeks 4, 24, 48, 96, and 144.|At Weeks 4, 24, 48, 96, and 144|Intention to treat: All participants with fasting self-reported adherence data were included.||percentage of prescribed medication||95% Confidence Interval|Mean
782159|NCT00811733|Secondary|Progression-free Survival|Time to disease progression is defined as the time from baseline to disease progression or death.|From baseline up to approximately 5 years|ITT Population. Participants who experienced disease progression or death were counted as events, and other participants were censored at the time of the last adequate assessment in the study.||days|events|Inter-Quartile Range|Median
782160|NCT00811733|Secondary|Duration of Response for All Responders (CR, PR, MR), as Assessed by the Investigator|Duration of response is defined as the time from the initial response to relapse/disease progression (DP) or death. DP for CR is defined as the reappearance of the IgM protein, new signs/symptoms attributable to WM, evidence of active disease or recurrence of bone marrow involvement by lymphoplasmacytic cells, or the appearance of any new lymph node >=1.5 centimeters on any axis. Progression for PR/MR is either a >=25% increase in IgM from the lowest attained response value or progression of lymphadenopathy, organomegaly, cytopenias, or other clinically significant signs/symptoms caused by WM.|From baseline up to approximately 5 years|ITT Population. Only those participants classified as responders were included in the analysis. Participants who had disease progression or death were counted as events, and other participants were censored at the date of the last adequate assessment in the study.||days|events|Inter-Quartile Range|Median
782161|NCT00811733|Secondary|Number of Participants With IgM Flare for Cycle 1 Response (Including the Redosing Cycle)|IgM is a basic antibody that is produced by B cells. It is the first antibody to appear in response to initial exposure to antigen. IgM flare is defined as an IgM level that increases by >25% from baseline (BL) and is associated with a response to treatment. Avoidance of IgM flare indicates the lack of an increase in IgM of >25% from BL.|Baseline and up to 27 months from the first dose of Cycle 1 (Study Day 1), and before Cycle 2 treatment|ITT Population. Only those participants who received Cycle 1 treatment (including the Redosing Cycle) were assessed.||participants|||Number
782162|NCT00811733|Secondary|Number of Participants With CR, PR, and MR for Cycle 1 (Excluding the Redosing Cycle), as Assessed by the Investigator|Response criteria were based on the Consensus Panel recommendations from the 2nd and 3rd International Workshop on WM. CR: Complete disappearance of serum monoclonal (SM) Immunoglobulin (Ig) E (IgE), measured centrally; resolution of adenopathy/organomegaly upon physical exam and computerized tomography (CT) scan; lymph nodes =<1.5 centimeters; absence of malignant cell by bone marrow histologic examination. PR: a >=50% reduction from baseline in the SM IgM concentration. MR: >=25%, but a <50% reduction of SM IgM from baseline.|Baseline and up to Study Week 16|ITT Population||participants|||Number
782163|NCT00811733|Secondary|Number of Participants With CR, PR, and MR for Cycle 1 (Including the Redosing Cycle), as Assessed by the Investigator|Response criteria were based on the Consensus Panel recommendations from the 2nd and 3rd International Workshop on WM. CR: Complete disappearance of serum monoclonal (SM) Immunoglobulin (Ig) E (IgE), measured centrally; resolution of adenopathy/organomegaly upon physical exam and computerized tomography (CT) scan; lymph nodes =<1.5 centimeters; absence of malignant cell by bone marrow histologic examination. PR: a >=50% reduction from baseline in the SM IgM concentration. MR: >=25%, but a <50% reduction of SM IgM from baseline.|Baseline and up to 27 months from the first dose of Cycle 1 (Study Day 1), and before Cycle 2 treatment|ITT Population||participants|||Number
782164|NCT00811733|Primary|Number of Participants With OR for Cycle 1 (Excluding the Redosing Cycle), as Assessed by the Investigator|OR (based on the Consensus Panel recommendations from the 2nd and 3rd International Workshop on WM) included Complete Response (CR), Partial Response (PR), or a Minor Response (MR). CR: Complete disappearance of serum monoclonal (SM) Immunoglobulin (Ig) E (IgE), measured centrally; resolution of adenopathy/organomegaly upon physical exam and computerized tomography (CT) scan; lymph nodes =<1.5 centimeters; absence of malignant cell by bone marrow histologic examination. PR: a >=50% reduction from baseline in the SM IgM concentration. MR: >=25%, but a <50% reduction of SM IgM from baseline.|Baseline and up to Study Week 16|ITT Population||participants|||Number
782165|NCT00811733|Primary|Number of Participants With Overall Response (OR) for Cycle 1 (Including the Redosing Cycle), as Assessed by the Investigator|OR (based on the Consensus Panel recommendations from the 2nd and 3rd International Workshop on WM) included Complete Response (CR), Partial Response (PR), or a Minor Response (MR). CR: Complete disappearance of serum monoclonal (SM) Immunoglobulin (Ig) E (IgE), measured centrally; resolution of adenopathy/organomegaly upon physical exam and computerized tomography (CT) scan; lymph nodes =<1.5 centimeters; absence of malignant cell by bone marrow histologic examination. PR: a >=50% reduction from baseline in the SM IgM concentration. MR: >=25%, but a <50% reduction of SM IgM from baseline.|Baseline and up to 27 months from the first dose of Cycle 1 (Study Day 1), and before Cycle 2 treatment|Intent-to-Treat (ITT) Population: all participants who were considered eligible for treatment and who had been exposed to study drug irrespective of the planned course of treatment.||participants|||Number
782166|NCT00811798|Primary|Number of Subjects Reporting Any Serious Adverse Event (SAE) and SAE(s) With a Causal Relationship to Vaccination as Assessed by the Investigator.|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|During the entire study period (Day 0 up to the telephone contact at Month 12).|||Subjects|||Number
782167|NCT00811850|Primary|Retrobulbar Blood Flow (End Diastolic Velocity) as Measured by Color Doppler Imaging in the Central Retinal Artery|End diastolic velocity (EDV) of retrobulbar blood flow as measured by color Doppler imaging (CDI) in the central retinal artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow of blood through a vessel. EDV is the maximum blood flow speed within a vessel at the end of diastole (minimum pressure exerted in a blood vessel in between heart beats).|1 Month|Intent-to-treat population, which consisted of all patients that started the study (randomized)||Centimeters per second (cm/s)||Standard Deviation|Mean
782168|NCT00811850|Primary|Retrobulbar Blood Flow (Peak Systolic Velocity) as Measured by Color Doppler Imaging in the Central Retinal Artery|Peak systolic velocity (PSV) of retrobulbar blood flow as measured by color Doppler imaging (CDI) in the central retinal artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow of blood through a vessel. PSV is the maximum blood flow speed within a vessel at the time of systole (maximum pressure exerted in a blood vessel).|1 Month|Intent-to-treat population, which consisted of all patients that started the study (randomized)||Centimeters per second (cm/s)||Standard Deviation|Mean
782725|NCT00807560|Secondary|Waist Measurement|Waist measurement in inches. This is not a primary outcome variable.|up to 44 weeks|||inches||Standard Deviation|Mean
782169|NCT00811850|Primary|Retrobulbar Blood Flow (End Diastolic Velocity) as Measured by Color Doppler Imaging in the Ophthalmic Artery|End diastolic velocity (EDV) of retrobulbar blood flow as measured by color Doppler imaging (CDI) in the ophthalmic artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow through a vessel. EDV is the maximum blood flow speed within a vessel at the end of diastole (minimum pressure exerted in a blood vessel in between heart beats).|1 Month|Intent-to-treat population, which consisted of all patients that started the study (randomized)||Centimeters per second (cm/s)||Standard Deviation|Mean
782170|NCT00811850|Primary|Retrobulbar Blood Flow (Peak Systolic Velocity) as Measured by Color Doppler Imaging in the Ophthalmic Artery|Peak systolic velocity (PSV) of retrobulbar blood flow as measured by color Doppler imaging (CDI) in the ophthalmic artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow of blood through a vessel. PSV is the maximum blood flow speed within a vessel at the time of systole (maximum pressure exerted in a blood vessel).|1 Month|Intent-to-treat population, which consisted of all patients that started the study (randomized)||Centimeters per second (cm/s)||Standard Deviation|Mean
782171|NCT00811850|Primary|Retrobulbar Blood Flow (End Diastolic Velocity) as Measured by Color Doppler Imaging in the Temporal Short Posterior Ciliary Artery|End diastolic velocity (EDV) of retrobulbar blood flow as measured by color Doppler imaging (CDI) in the temporal short posterior ciliary artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow of blood through a vessel. EDV is the maximum blood flow speed within a vessel at the end of diastole (minimum pressure exerted in a blood vessel in between heart beats).|1 Month|Intent-to-treat population, which consisted of all patients that started the study (randomized)||Centimeters per second (cm/s)||Standard Deviation|Mean
782172|NCT00811850|Primary|Retrobulbar Blood Flow (Peak Systolic Velocity) as Measured by Color Doppler Imaging in the Temporal Short Posterior Ciliary Artery|Peak systolic velocity (PSV) of retrobulbar blood as measured by color Doppler imaging (CDI) in the temporal short posterior ciliary artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow of blood through a vessel. PSV is the maximum blood flow speed within a vessel at the time of systole (maximum pressure exerted in the blood vessel).|1 Month|Intent-to-treat population, which consisted of all patients that started the study (randomized)||Centimeters per second (cm/s)||Standard Deviation|Mean
782173|NCT00811850|Primary|Retrobulbar Blood Flow (End Diastolic Velocity) as Measured by Color Doppler Imaging in the Nasal Short Posterior Ciliary Artery|End diastolic velocity (EDV) of retrobulbar blood flow as measured by color Doppler imaging (CDI) in the nasal short posterior ciliary artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow of blood through a vessel. EDV is the maximum blood flow speed within a vessel at the end of diastole (minimum pressure exerted in a blood vessel in between heart beats).|1 Month|Intent-to-treat population, which consisted of all patients that started the study (randomized)||Centimeters per second (cm/s)||Standard Deviation|Mean
782174|NCT00811850|Primary|Retrobulbar Blood Flow (Peak Systolic Velocity) as Measured by Color Doppler Imaging in the Nasal Short Posterior Ciliary Artery|Peak systolic velocity (PSV) of retrobulbar blood flow as measured by color Doppler imaging (CDI) in the nasal short posterior ciliary artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow of blood through a vessel. PSV is the maximum blood flow speed within a vessel at the time of systole (maximum pressure exerted in a blood vessel).|1 Month|Intent-to-treat population, which consisted of all patients that started the study (randomized)||Centimeters per second (cm/s)||Standard Deviation|Mean
782197|NCT00811941|Primary|Number of Patients With Adverse Events (AEs)|Overview of AEs|Serious Adverse Events: 52 weeks and a safety follow-up (visit/telephone call) scheduled for 4 weeks after completion of the study or after withdrawal from the study. Other Adverse Events: 52 weeks.|All-patients-treated set (APTS) – all patients in the APRS excluding those with no recorded investigational medicinal product (IMP) intake and all IMP returned||participants|||Number
782182|NCT00811941|Secondary|Liver Function Test Alanine Aminotransferase (ALAT)|ALAT values|Week 52|FAS||IU/L||Geometric Coefficient of Variation|Geometric Mean
782183|NCT00811941|Secondary|Liver Function Test Gamma-glutamyl Transferase (GGT)|GGT values|Week 52|FAS||IU/L||Geometric Coefficient of Variation|Geometric Mean
782184|NCT00811941|Secondary|Change in Clinical Status Using the CGI-I|The Clinical Global Impression - Global Improvement (CGI-I) provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7- point scale ranging from 1 (very much improved) to 7 (very much worse).|Week 52|FAS||units on a scale||Standard Error|Mean
782185|NCT00811941|Secondary|Change From Baseline in Clinical Status Using CGI-S|The Clinical Global Impression - Severity of Illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients).|Baseline and Week 52|FAS||units on a scale||Standard Error|Mean
782186|NCT00811941|Secondary|Drinking Risk Level (RSDRL) Response|RSDRL response was defined as a downward shift from baseline in Drinking Risk Level (DRL); for patients at very high risk at Baseline: a shift to medium risk or below, and for patients at high or medium risk at Baseline: a shift to low risk or below.|Month 13|FAS||percentage of participants|||Number
782187|NCT00811941|Secondary|Change From Baseline in the Monthly Total Alcohol Consumption (TAC)|TAC was defined as mean daily alcohol consumption in g/day over a month (28 days).|Baseline and Month 13|FAS||g||Standard Error|Mean
782188|NCT00811941|Secondary|Change From Baseline in the Monthly Number of Heavy Drinking Days (HDDs)|Number of HDDs over a month (28 days), where one HDD was defined as a day with alcohol consumption ≥60 g for men and ≥40 g for women.|Baseline and Month 13|FAS||days||Standard Error|Mean
782189|NCT00811941|Secondary|Liver Function Test Alanine Aminotransferase (ALAT)|ALAT values|Week 24|FAS||IU/L||Geometric Coefficient of Variation|Geometric Mean
782190|NCT00811941|Secondary|Liver Function Test Gamma-glutamyl Transferase (GGT)|GGT values|Week 24|FAS||IU/L||Geometric Coefficient of Variation|Geometric Mean
782191|NCT00811941|Secondary|Change in Clinical Status Using the CGI-I|The Clinical Global Impression - Global Improvement (CGI-I) provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7- point scale ranging from 1 (very much improved) to 7 (very much worse).|Week 24|FAS||units on a scale||Standard Error|Mean
782192|NCT00811941|Secondary|Change From Baseline in Clinical Status Using CGI-S|The Clinical Global Impression - Severity of Illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients).|Baseline and Week 24|FAS||units on a scale||Standard Error|Mean
782193|NCT00811941|Secondary|Drinking Risk Level (RSDRL) Response|RSDRL response was defined as a downward shift from baseline in Drinking Risk Level (DRL); for patients at very high risk at Baseline: a shift to medium risk or below, and for patients at high or medium risk at Baseline: a shift to low risk or below.|Month 6|FAS||percentage of participants|||Number
782194|NCT00811941|Primary|Change From Baseline in the Monthly Total Alcohol Consumption (TAC)|TAC was defined as mean daily alcohol consumption in g/day over a month (28 days).|Baseline and Month 6|FAS||g||Standard Error|Mean
782195|NCT00811941|Primary|Change From Baseline in the Monthly Number of Heavy Drinking Days (HDDs)|Number of HDDs over a month (28 days), where one HDD was defined as a day with alcohol consumption ≥60 grams (g) for men and ≥40 g for women.|Baseline and Month 6|Full-analysis set (FAS) - all patients in the APTS who had at least one valid post-baseline assessment in the main treatment period of both co-primary efficacy variables (HDD and TAC) and had an average alcohol consumption at medium Drinking Risk Level (DRL) or above according to WHO criteria at Baseline.||days||Standard Error|Mean
782196|NCT00811941|Primary|Percentage of Patients Who Withdrew Due to Intolerance to Treatment||Baseline to Week 52|All-patients-treated Set (APTS)||percentage of participants|||Number
782726|NCT00807560|Secondary|Waist Measurement|Waist measurement in inches. This is not a primary outcome variable.|baseline|||inches||Standard Deviation|Mean
782199|NCT00811954|Secondary|Change in Waist:Height Ratio From Baseline|Change was calculated as the waist:height ratio at week (48, 96, and 144) minus the baseline waist:height ratio.|Study entry to weeks 48, 96, and 144|Intention to treat: All participants with waist circumference data were included, complete-case approach.||cm:cm||95% Confidence Interval|Mean
782200|NCT00811954|Secondary|Change in Waist Circumference From Baseline|Change was calculated as the waist circumference (based on mid-waist circumference) at week (48, 96, and 144) minus the baseline waist circumference.|Study entry to weeks 48, 96, and 144|Intention to treat: All participants with waist circumference data were included, complete-case approach.||cm||95% Confidence Interval|Mean
782201|NCT00811954|Secondary|Change in Framingham 10-year Risk of MI or Coronary Death From Baseline|"Only risk score estimated with fasting lipid results were included. Change was calculated as the Framingham 10-year risk of MI or coronary death at week (48, 96, and 144) minus the baseline Framingham 10-year risk of MI or coronary death. Framingham 10-year risk of MI or coronary death was calculated using Hear Coronary Heart Disease (10-year risk) found at https://www.framinghamheartstudy.org/risk-functions/coronary-heart-disease/hard-10-year-risk.php.
Framingham 10-year risk of MI or coronary death was calculated according to age, laboratory values of total cholesterol and HDL cholesterol, smoking status, systolic blood pressure, and treatment for hypertension. The Framingham 10-year risk of MI or coronary death was calculated as: for males: <0 point (<1 percent risk) up to ≥17 points (≥30 percent risk); whereas for females: <9 points (<1 percent risk) up to ≥25 points (≥30 percent risk). Higher scores indicate high cardiovascular risk."|Study entry to weeks 48, 96, and 144|Intention to treat: All participants with fasting lipids data were included, complete-case approach.||percent risk||95% Confidence Interval|Mean
782202|NCT00811954|Secondary|Change in Fasting Plasma Glucose Level From Baseline|Only fasting results are included. Change was calculated as the fasting plasma glucose at week (48, 96, and 144) minus the baseline fasting plasma glucose.|Study entry to weeks 48, 96, and 144|Intention to treat: All participants with fasting lipids data were included, complete-case approach.||mg/dL||95% Confidence Interval|Mean
782203|NCT00811954|Secondary|Change in Fasting Triglycerides Level From Baseline|Only fasting results are included. Change was calculated as the fasting triglycerides at week (48, 96, and 144) minus the baseline fasting triglycerides.|Study entry to weeks 48, 96, and 144|Intention to treat: All participants with fasting lipids data were included, complete-case approach.||mg/dL||95% Confidence Interval|Mean
782204|NCT00811954|Secondary|Change in Fasting HDL Cholesterol Level From Baseline|Only fasting results are included. Change was calculated as the fasting HDL cholesterol at week (48, 96, and 144) minus the baseline fasting HDL cholesterol.|Study entry to weeks 48, 96, and 144|Intention to treat: All participants with fasting lipids data were included, complete-case approach.||mg/dL||95% Confidence Interval|Mean
782205|NCT00811954|Secondary|Change in Fasting Total Cholesterol Level From Baseline|Only fasting results are included. Change was calculated as the fasting total cholesterol at week (48, 96, and 144) minus the baseline fasting total cholesterol.|Study entry to weeks 48, 96, and 144|Intention to treat: All participants with fasting lipids data were included, complete-case approach.||mg/dL||95% Confidence Interval|Mean
782206|NCT00811954|Secondary|Incidence of Targeted Serious Non-AIDS Defining Events (Renal Failure, Liver Disease, Serious Metabolic Disorder, and CVD)|The incidence of targeted serious non-AIDS defining events was estimated as number of incident events over total person years of follow-up. Multiple new events for a single subject were counted toward events totals in estimation of event incidence; generalized estimating equations were used to estimation of robust standard errors for the incidence.|Study entry to off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable|Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment.||events per 100 person-years||95% Confidence Interval|Number
782207|NCT00811954|Secondary|Incidence of Death or AIDS Defining Events (CDC Category C)|The incidence of death or AIDS defining events (CDC category C) was estimated as number of incident events over total person years of follow-up. Multiple new events for a single subject were counted toward events totals in estimation of event incidence; generalized estimating equations were used to estimation of robust standard errors for the incidence.|Study entry to off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable|Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment.||events per 100 person-years||95% Confidence Interval|Number
782208|NCT00811954|Secondary|CD4+ T-cell Count Changes From Baseline|Change was calculated as the CD4+ T-cell count at week (24, 48, 96, and 144) minus the baseline CD4+ T-cell count|Study entry to weeks 24, 48, 96, and 144|Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment. Missing data were assumed missing completely at random.||cells/mm^3||95% Confidence Interval|Mean
782209|NCT00811954|Secondary|CD4+ T-cell Count|The absolute levels of CD4+ T-cell counts (cells/mm3)|At Weeks 24, 48, 96, and 144|Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment. Missing data were assumed missing completely at random.||cells/mm^3||95% Confidence Interval|Mean
782210|NCT00811954|Secondary|Presence of Mutations Associated With INI Resistance|The number of participants with INI resistance determined by the Stanford resistance scoring algorithm (Version 6.3). All sequencing was performed regardless of status on randomized treatment at the time of virologic failure; no sequencing was performed on subjects not meeting virologic failure.|At the virologic failure at any time throughout the study (up to 213 weeks)|Participants who met the criteria for virologic failure restricted to participants in the RAL group and random sample of participants in PI/RTV groups with successful sequencing at virologic failure.||participants|||Number
782211|NCT00811954|Secondary|Presence of Mutations Associated With ATV/RTV or DRV/RTV Resistance|The number of participants with ATV/RTV or DRV/RTV resistance determined by the Stanford resistance scoring algorithm (Version 6.3). All sequencing was performed regardless of status on randomized treatment at the time of virologic failure; no sequencing was performed on subjects not meeting virologic failure.|At the virologic failure at any time throughout the study (up to 213 weeks)|Participants who met the criteria for virologic failure with successful sequencing at virologic failure||participants|||Number
782727|NCT00807560|Secondary|Percent Completion|Percent of participants who completed the trial to assess feasibility and retention in the trial|at 44 weeks|||percentage of participants|||Number
782212|NCT00811954|Secondary|Presence of Mutations Associated With NRTI Resistance|The number of participants with NRTI resistance determined by the Stanford resistance scoring algorithm (Version 6.3). All sequencing was performed regardless of status on randomized treatment at the time of virologic failure; no sequencing was performed on subjects not meeting virologic failure.|At the virologic failure at any time throughout the study (up to 213 weeks)|Participants who met the criteria for virologic failure with successful sequencing at virologic failure||participants|||Number
782213|NCT00811954|Secondary|Cumulative Probability of Time to Loss of Virologic Response (TLOVR) by Week 96|"The Kaplan-Meier estimate of the cumulative probability of TROVR by week 96.
A composite TLOVR endpoint defined in the CDER of the FDA document Guidance for Industry - Antiretroviral Drugs Using Plasma HIV RNA Measurements - Clinical Consideration for Accelerated and Traditional Approval (Appendix B, pages 20) http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070968.pdf.
If participants never achieved a confirmed HIV-1 RNA≤200 cp/mL (on two consecutive visits) prior to death, permanent discontinuation of randomized treatment, or time of last available HIV-1 RNA evaluation, TLOVR was equal to 0; otherwise, TLOVR was the earliest time of permanent discontinuation of randomized treatment prior to study close-out period, time to confirmed levels >200 cp/mL, or time to death. If TLOVR is immediately preceded by a single missing scheduled visit or multiple consecutive missing scheduled visits, TLOVR is replaced by the first such missing visit."|From study entry to week 96|Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment.||cumulative probability per 100 persons||95% Confidence Interval|Number
782214|NCT00811954|Secondary|Cumulative Incidence of First Adverse Event by Week 96|"The cumulative incidence of first adverse event (with and without total bilirubin and creatine kinase and measured from study entry) by week 96 was estimated using methods for competing risks. Discontinuation of randomized treatment prior to an adverse event was considered a competing event.
The time to the first of any post-entry Grade 2, 3, or 4 sign or symptom, or Grade 3 or 4 laboratory abnormality while on randomization. The protocol required reporting of signs and symptoms and laboratory values as follow: all signs and symptoms grade ≥2 post-entry to week 48, signs and symptoms grade >3 after week 48, and laboratory values grade >3 and all signs, symptoms, and laboratory values that led to a change in treatment, regardless of grade throughout out all post-entry follow-up."|From study entry to week 96|As treated: Participants who had events occurring while on randomized treatment are included in this analysis: grade 2 events occurring in the after 48 weeks on study are excluded. Participants were analyzed per original assigned randomized treatment.||cumulative events per 100 persons||95% Confidence Interval|Number
782215|NCT00811954|Primary|Cumulative Incidence of Discontinuation of the RAL or PI Component of Randomized Treatment for Toxicity by Week 96|The cumulative incidence of discontinuation for toxicity by week 96 was estimated using competing risks with treatment discontinuation for other reasons considered as a competing event; participants completing the study on the RAL or PI component of their randomized regimen were considered censored at the earliest of the date of last patient contact and off study date.|From study entry to week 96|Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment.||cumulative events per 100 persons||95% Confidence Interval|Number
782216|NCT00811954|Primary|Cumulative Probability of First Virologic Failure by Week 96|"The Kaplan-Meier estimate of the cumulative probability of virologic failure by week 96.
Time to virologic failure was defined as the first time from study entry to the first of two consecutive HIV-1 RNA >1000 copies/mL at or after week 16 and before week 24, or >200 copies/mL at or after week 24. Week 16 is defined to occur between 14 (98 days) and 18 weeks (126 days) after study entry, week 24 is defined to occur between 22 (154 days) and 26 (182 days) after study entry, and week 96 is defined to occur between 88 (616 days) and 104 (728 days) after study entry."|From study entry to week 96|Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment.||cumulative probability per 100 persons||95% Confidence Interval|Number
782217|NCT00812006|Secondary|Treatment Satisfaction (TS)|Patient satisfaction was assessed on a paper diary by the participants. Level of satisfaction was rated as: completely satisfied, very satisfied, somewhat satisfied, neither satisfied nor dissatisfied, somewhat dissatisfied, very dissatisfied, or completely dissatisfied. The overall 24-hour assessment of study medication was dichotomized to Satisfaction (completely satisfied, very satisfied, somewhat satisfied) and Non-satisfaction (neither satisfied nor dissatisfied, somewhat dissatisfied, very dissatisfied, or completely dissatisfied) for analysis.|24 hours post dose|Full Analysis Set, which included all randomized participants who had at least one evaluable attack. To be considered an evaluable attack, the participant must have administered study treatment for this attack and have both a baseline severity measurement and post-dose satisfaction measurement at the 24-hour time point.||Attacks|||Number
782218|NCT00812006|Secondary|Normal Rating of Functional Disability (NRFD)|Level of functional disability was assessed on a paper diary by the participants. Level of functional disability was rated as: normal, mildly impaired, severely impaired, or unable to do activities, requires bedrest. Functional disability ratings was dichotomized to Normal and Not Normal (mildly impaired, severely impaired, or unable to do activities, requires bedrest) for analysis.|2 hours post dose|Full Analysis Set, which included all randomized participants who had at least one evaluable attack. To be considered an evaluable attack, the participant must have administered study treatment for this attack and have both a baseline severity measurement and at least one post-dose efficacy measurement at or prior to the 2-hour time point.||Attacks|||Number
782219|NCT00812006|Secondary|Pain Freedom (PF)|Headache pain severity, relative to the administration of study medication, was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild pain), 2 (moderate pain), or 3 (severe pain). Pain freedom (PF) is defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 0 (no pain) post dose.|2 hours post dose|Full Analysis Set, which included all randomized participants who had at least one evaluable attack. To be considered an evaluable attack, the participant must have administered study treatment for this attack and have both a baseline severity measurement and at least one post-dose efficacy measurement at or prior to the 2-hour time point.||Attacks|||Number
782523|NCT00805935|Secondary|Percentage of Participants With Ongoing Pregnancy at Week 9|Clinical pregnancy is the confirmation of the presence of intrauterine gestational sacs on pregnancy ultrasound examination.|approximately Day 65|Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication||Percentage of participants|||Number
782220|NCT00812006|Secondary|Sustained Pain Relief (SPR)|24-hour sustained pain relief (defined as pain relief at 2 hours post dose, with no administration of any rescue medication and with no occurrence of a moderate/severe headache during the respective period after dosing with the blinded study medication.|2 - 24 hours post dose|Full Analysis Set, which included all randomized participants who had at least one evaluable attack. To be considered an evaluable attack, the attack must have met the FAS criteria for PR at 2 hours post-dose, and from 2-24 hours the participant either answered 24-hour headache recurrence question or didn't have PR at any time or took rescue.||Attacks|||Number
782221|NCT00812006|Primary|Pain Relief (PR)|Pain severity was rated by the participants in a paper diary. Pain severity rating scale : 0 (no pain), 1 (mild pain), 2 (moderate pain), or 3 (severe pain). Pain relief (PR) is defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 1/0 post dose.|2 hours post dose|Full Analysis Set, which included all randomized participants who had at least one evaluable attack. To be considered an evaluable attack, the participant must have administered study treatment for this attack and have both a baseline severity measurement and at least one post-dose efficacy measurement at or prior to the 2-hour time point.||Attacks|||Number
782222|NCT00812097|Primary|Overall Mean Change in Circumferential Chest Size|Change in Chest Size was calculated by subtracting the chest circumference prior to surgery from the chest circumference measured at the end of the study|Change from baseline to 10 years post-baseline|All enrolled subjects are included.||inches||Standard Deviation|Mean
782223|NCT00812097|Primary|10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Explantation With or Without Replacement|Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest.|10 years|All enrolled subjects are included.||percentage of subjects||95% Confidence Interval|Number
782224|NCT00812097|Primary|10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Infection|Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest.|10 years|All enrolled subjects are included.||percentage of subjects||95% Confidence Interval|Number
782225|NCT00812097|Primary|10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Baker III, IV Capsular Contracture|"Baker III was identified as firm with visible distortion and Baker IV was identified as obvious spherical distortion. Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest."|10 years|All enrolled subjects are included.||percentage of subjects||95% Confidence Interval|Number
782226|NCT00812097|Primary|10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Any Reoperation|Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest.|10 years|All enrolled subjects are included.||percentage of subjects||95% Confidence Interval|Number
782227|NCT00812110|Primary|Number of Participants Who Received Influenza Vaccine.|Caregivers identified for participation were offered influenza vaccine. This describes the number who accepted vaccination|1 hour|||participants|||Number
782228|NCT00812110|Secondary|Background Rate of Influenza Vaccination in the Parents/Caregivers of High Risk Pediatric Patients in a Low Income Population?|Number of participants who received influenza vaccine the prior year.|16 months|||participants|||Number
782229|NCT00812253|Secondary|Cardiac Index||72 hours||||||
782230|NCT00812253|Secondary|Brain Natriuretic Peptide (BNP)|Brain natriuretic peptide (BNP) was measured at day 3|72 hours|||pg/ml||Inter-Quartile Range|Median
782231|NCT00812253|Secondary|Quality of Life||30 day||||||
782232|NCT00812253|Secondary|Heart Rate Variability||72 hours||||||
782233|NCT00812253|Secondary|Hospital Readmission|All-cause hospital readmission at 30 days after discharge|30 days|||participants|||Number
782234|NCT00812253|Primary|Hospital Length of Stay|Duration of hospitalization in days|Days|||days||Inter-Quartile Range|Median
782235|NCT00812331|Secondary|Terminal Elimination Half-life (t1/2,Term) of TMC435|The table below shows the terminal plasma half-life for TMC435 in participants analyzed by genotype of hepatitis C virus infection. The terminal plasma half-life of a drug is the time in hours required for the concentration of a drug in the body to fall to 50% after having reached a state of equilibrium following administration.|Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7|Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC435).||hours||Full Range|Median
782236|NCT00812331|Secondary|Elimination Rate Constant of TMC435|In the table below, median values for the elimination rate constant (the rate at which a drug is removed from the body expressed per unit of time, e.g., fraction/hour) for TMC435 are shown for participants by genotype of hepatitis C virus infection.|Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7|Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC435).||1/hour||Full Range|Median
782237|NCT00812331|Secondary|Area Under the Plasma Concentration-time Curve From Time of Administration up to the Last Time Point With a Measurable Concentration After Dosing (AUClast) of TMC435|The table below shows the area under the plasma concentration-time curve from time of administration up to the last time point with a measurable concentration after dosing (AUClast) on Day 7 for TMC435 by genotype of hepatitis C virus infection.|Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7|Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC435).||ng*h/mL||Full Range|Median
782238|NCT00812331|Secondary|Area Under the Plasma Concentration-time Curve From the Time of Administration up to 24 Hours After Dosing (AUC24h) of TMC435|The table below shows the area under the plasma concentration-time curve from the time of administration up to 24 hours after dosing (AUC24h) of TMC435 on Day 7 for all participants by genotype of hepatitis C virus infection.|Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7|Intent-to-treat (ITT) population - as all randomized participants who received at least 1 dose of study medication (TMC435).||ng*h/mL||Full Range|Median
782239|NCT00812331|Secondary|Fluctuation Index (FI) of TMC435|The table below shows the percentage of fluctuation (FI) (defined as the variation between maximum and minimum TMC435 plasma concentrations at steady-state) of TMC435 on Day 7 for participants by genotype of hepatitis C virus infection.|Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7|Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC435).||% fluctuation||Full Range|Median
782240|NCT00812331|Secondary|Average Steady-State Plasma Concentration (Css,av) of TMC435|The table below shows the average steady-state TMC435 plasma concentration (Css,av) for all participants by genotype of hepatitis C virus infection on Day 7 during the TMC435 treatment period.|Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7|Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC435).||ng/mL||Full Range|Median
782241|NCT00812331|Secondary|Time to Reach the Maximum Plasma Concentration (Tmax) of TMC435|The table below shows the median time in hours for all participants (by genotype of hepatitis C virus infection) to reach the maximum plasma concentration (tmax) of TMC435 following treatment.|Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7|Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC435).||hours||Full Range|Median
782242|NCT00812331|Secondary|Maximum Plasma Concentration (Cmax) of TMC435|The table below shows the median maximum plasma concentration (Cmax) for all participants by genotype of hepatitis C virus infection on Day 7 of the TMC435 treatment period.|Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7|Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC435).||ng/mL||Full Range|Median
782243|NCT00812331|Secondary|Minimum Plasma Concentration (Cmin) of TMC435|The table below shows the median minimum plasma concentration (Cmin) for all participants on Day 7 of the TMC435 treatment period.|Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7|Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC435).||ng/mL||Full Range|Median
782244|NCT00812331|Secondary|Predose Plasma Concentration (C0h) of TMC435|The table below shows the median predose plasma concentration (C0h) for all participants on Day 7 of the TMC435 treatment period.|Predose on Day 7|Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC435).||ng/mL||Full Range|Median
782245|NCT00812331|Secondary|Number of Participants Who Experienced Viral Breakthrough During TMC435 Treatment Period|The table below shows the number of participants who experienced viral breakthrough (defined as an increase greater than 1 log10 IU/mL in plasma level of hepatitis C virus [HCV] ribonucleic acid [RNA] from the lowest level reached, or a HCV RNA level greater than 100 IU/mL in participants who previously had HCV RNA levels undetectable [less than 25 IU/mL undetectable] or not quantifiable [less than 25 IU/mL detectable]) during the 7-day TMC435 treatment period.|During the 7-day of TMC435 treatment period|Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC435).||Participants|||Number
782246|NCT00812331|Secondary|Number of Participants With Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels Below the Limit of Quantification (Less Than 25 IU/mL) and Limit of Detection (Less Than 25 IU/mL Undetectable) During the TMC435 Treatment Period|The table below shows the number of participants with plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels below limit of quantification (less than 25 IU/mL) and limit of detection (less than 25 IU/mL undetectable), respectively, during the 7-day TMC435 treatment period.|Baseline, Day 3, Day 5 and Day 7|Intent-to-treat (ITT) Population - all randomized subjects who received at least 1 dose of study medication (TMC435)||Participants|||Number
782247|NCT00812331|Secondary|Number of Participants With a Decrease From Baseline of Greater Than or Equal to 2 log10 IU/mL in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) During the TMC435 Treatment Period|The table below shows the number of participants with a decrease from baseline of greater than or equal to 2 log10 IU/mL in HCV RNA during the 7-day TMC435 treatment period.|Baseline, Day 3, Day 5 and Day 7|Intent-to-treat (ITT) Population- all randomized subjects who received at least 1 dose of study medication (TMC435)||Participants|||Number
782248|NCT00812331|Primary|Change From Baseline in log10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels|The table below shows the mean changes from baseline in HCV RNA values (log10 IU/mL) per genotype on Day 3 and Day 7 during the TMC435 treatment period.|Baseline, Day 3, and Day 7|Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC435).||log10 IU/mL||Standard Error|Mean
782249|NCT00812461|Secondary|Liver Function Test Alanine Aminotransferase (ALAT)|ALAT values|Week 24|FAS||IU/L||Geometric Coefficient of Variation|Geometric Mean
782250|NCT00812461|Secondary|Liver Function Test Gamma-glutamyl Transferase (GGT)|GGT values|Week 24|FAS||IU/L||Geometric Coefficient of Variation|Geometric Mean
782251|NCT00812461|Secondary|Change in Clinical Status Using the CGI-I|The Clinical Global Impression - Global Improvement (CGI-I) provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).|Week 24|FAS||units on a scale||Standard Error|Mean
782252|NCT00812461|Secondary|Change From Baseline in Clinical Status Using CGI-S|The Clinical Global Impression - Severity of Illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients).|Baseline and Week 24|FAS||units on a scale||Standard Error|Mean
782253|NCT00812461|Secondary|Drinking Risk Level (RSDRL) Response|RSDRL response was defined as a downward shift from baseline in Drinking Risk Level (DRL); for patients at very high risk at Baseline: a shift to medium risk or below, and for patients at high or medium risk at Baseline: a shift to low risk or below.|Month 6|FAS||percentage of participants|||Number
782254|NCT00812461|Primary|Change From Baseline in the Monthly Total Alcohol Consumption (TAC)|TAC was defined as mean daily alcohol consumption in g/day over a month (28 days).|Baseline and Month 6|FAS||g||Standard Error|Mean
782368|NCT00813150|Secondary|Overall Survival (OS)|Time interval in months time from randomisation to death from any cause.|From the date of randomization until Month 49|Intent-to-treat (ITT): Participants received at least 1 dose of study medication were included in the ITT analysis set. Participants still alive at the end of the study or dropped out will be censored with the last available date.||Months||95% Confidence Interval|Median
782255|NCT00812461|Primary|Change From Baseline in the Monthly Number of Heavy Drinking Days (HDDs)|Number of HDDs over a month (28 days), where one HDD was defined as a day with alcohol consumption ≥60 grams (g) for men and ≥40 g for women.|Baseline and Month 6|Full-analysis set (FAS) - all patients in the all-patients-treated set (APTS) who had at least one valid post-baseline assessment in the main treatment period of both co-primary efficacy variables (HDD and TAC) and had an average alcohol consumption at medium Drinking Risk Level (DRL) or above according to WHO criteria at Baseline.||days||Standard Error|Mean
782256|NCT00812487|Secondary|Mean Glucose|mean sensor glucose|24 hours|||mg/dl||Standard Deviation|Mean
782257|NCT00812487|Secondary|Coefficient of Variation (CV)|CV is a measure of glycemic variability|24 hours|||percentage (mean glucose/SD)||Standard Deviation|Mean
782258|NCT00812487|Primary|Hospital Readmission|All-cause hospital readmission within 30 days|30 days|||participants|||Number
782259|NCT00812487|Primary|Hospital Length of Stay|Duration of hospitalization|participants were followed for the duration of hospital stay, median hospital stay 8 day|||days||Inter-Quartile Range|Median
782260|NCT00812487|Secondary|Glycemic Lability Index (GLI)|GLI is a measure of glycemic variability. GLI is the sum of the square of the difference between successive glucose measurements divided by the difference in time between measurements|24 hours|||(mg/dl)^2/hr*day-1||Inter-Quartile Range|Median
782261|NCT00812487|Secondary|Quality of Life|Quality of Life was measured using the Minnesota Living with Heart Failure Questionnaire, which is a 21 question survey that uses a likert scale of 0-5. Each item asks over the past 4 weeks whether they have had a particular symptom of heart failure and to classify the response as no symptoms (0) to having the symptom very much (5). Responses are summed for a total score (0-105).|30 days|||units on a scale||Inter-Quartile Range|Median
782262|NCT00812487|Secondary|Brain Natriuretic Peptide (BNP)|Laboratory analyses were performed by the study institution's Clinical Research Center using standard commercial kits|72 hours|||pg/ml||Inter-Quartile Range|Median
782263|NCT00812487|Secondary|High Sensitivity C-reactive Protein (Hs-CRP)|High sensitivity C-reactive Protein (hs-CRP) is a measure of inflammation. hsCRP (range 0-15 mg/L) was performed using Immunlite 1000 assay (Siemens; Erlangen, Germany).|72 hours|||mg/dl||Inter-Quartile Range|Median
782264|NCT00812487|Secondary|Pre-ejection Period (PEP)|Pre-ejection period (PEP) is the time between the onset of electrical depolarization of the ventricle and the opening of the aortic valve, a measure of sympathetic tone. It is obtained noninvasively using cardiac impedance obtained using a Bionex system (Mindware, Gahanna, OH). PEP is measured in milliseconds; lower values reflect higher sympathetic tone.|24 hours|||ms||Standard Deviation|Mean
782265|NCT00812487|Secondary|High Frequency Heart Rate Variability|High frequency heart rate variability (HF HRV)is a measure of cardiac autonomic tone. Electrocardiographic measures were obtained using a Bionex system (Mindware, Gahanna, OH). The electrocardiogram was performed in the standard lead II configuration. Software (Mindware, Gahanna, OH) was used to derive HF HRV. HF HRV was calculated using power spectral analysis.|24 hours|||ms^2||Inter-Quartile Range|Median
782266|NCT00812565|Secondary|Left and Right Hippocampal Cerebral Glucose Metabolism at Baseline and at Week 24|Cerebral glucose metabolism was measured in validated 3 dimensional statistic surface projection analysis (Cortex ID®, GE Healthcare), transversal/coronal/sagittal-slice analysis (HERMES BRASS), and voxel-wise whole brain analysis (SPM5) using [18F]fluorodeoxyglucose positron emission tomography.|Baseline to Week 24|Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.||µCi/mL||Standard Deviation|Mean
782267|NCT00812565|Secondary|Change From Screening in Whole Brain and Hippocampal Volume at Week 12 and Week 24|The volume of the whole brain and of the left and right hippocampus was measured using high-resolution structural coronal 3D heavily T1-weighted gradient-echo sequence magnetic resonance imaging. All evaluations were done centrally by Professor Frederik Barkhof at the Image Analysis Centre, VU Medical Center, Amsterdam, Netherlands. A negative change score indicates loss of brain volume.|Screening to Week 24|Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.||cm^3||Standard Deviation|Mean
782268|NCT00812565|Secondary|Change From Baseline in the Clinical Dementia Ratio, Sum of Boxes (CDR-SOB) Score at Week 12 and Week 24|A semi-structured interview was conducted by a physician, neuropsychologist, psychometrician, or certified study coordinator with the patient and a caregiver. Based on the results of the interview, the patient was rated on 6 domains of cognition and function: Memory, orientation, judgment/problem solving, community activities, home and hobbies, and personal care. Each domain is rated from 0 = no dementia; 0.5 = questionable dementia, mild cognitive impairment; 1 = mild dementia; 2 = moderate dementia; 3 = severe dementia. The total score ranges from 0 to 18 with a higher score indicating more dementia. A negative change score indicates improvement.|Baseline to Week 24|Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.||Units on a scale||Standard Deviation|Mean
782269|NCT00812565|Secondary|Change From Baseline in the Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADAS-ADL) Score at Week 12 and Week 24|The ADAS-ADL consists of 23 questions that measure the ability of a person to perform basic activities of daily living, such as eating, walking, bathing, grooming, and dressing. The test is administered by a neuropsychologist, psychometrician, or certified study coordinator. The total score ranges from 0 to 78 with a lower score indicating more impaired ability. A positive change score indicates improvement.|Baseline to Week 24|Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.||Units on a scale||Standard Deviation|Mean
782300|NCT00812929|Secondary|Assessment of Hematology Parameters: Mean Corpuscle Volume (MCV)|Blood samples were collected for the assessment of hematology parameter for MCV at pre dose and 25 hours and 30 minutes post dose. Participants had to fast for at least 8 hours prior to visit. During treatment periods, fasting continued until a light meal was allowed 1 hour post dose.|Pre dose and 25 hours and 30 minutes post dose of each treatment period|All Subjects Population. Only those participants with data available at the indicated time points were analyzed.||Femtoliter||Standard Deviation|Mean
782270|NCT00812565|Secondary|Change From Baseline in the Alzheimer’s Disease Assessment Scale, Cognitive Part (ADAS Cog) Score at Week 12 and Week 24|The ADAS cog consists of 11 items that assess cognitive areas that are often impaired in Alzheimer’s disease, specifically learning (word list), naming (objects), following commands (1 to 5 elements), ideational praxis (mail a letter), constructional praxis (copy 4 figures), orientation (person, time and place), recognition memory (from a second word list), and remembering test instructions (from the recognition subtest). The test includes 3 additional subjective scales that assess spoken language ability, word finding difficulty, and comprehension. The test is administered by a neuropsychologist, psychometrician, or certified study coordinator. The total score ranges from 0 to 70 with a higher score indicating greater cognitive impairment. A negative change score indicates improvement.|Baseline to Week 24|Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.||Units on a scale||Standard Deviation|Mean
782271|NCT00812565|Secondary|Change From Baseline in the Mini Mental Status Examination (MMSE) Score at Week 12 and Week 24|The MMSE test contains 30 questions that assess 8 cognitive domains (orientation to time, orientation to place, registration, attention and calculation, recall, language, repetition, and complex commands). The test is administered by a neuropsychologist, psychometrician, or certified study coordinator. The total score ranges from 0 (severe impairment) to 30 (no impairment), with a higher score indicating a better mental status. A positive change score indicates improvement.|Baseline to Week 24|Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.||Units on a scale||Standard Deviation|Mean
782272|NCT00812565|Secondary|Change From Baseline in Tau and Phosphorylated Tau in Cerebral Spinal Fluid 24-48 Hours After the Last Infusion|Samples for determining tau and phosphorylated tau in cerebral spinal fluid were processed at a central laboratory using commercially available kits from Innogenetics NV (INNOTEST® hTau Ag, INNOTEST PHOSPHO-TAU (181P); Gent, Belgium). To measure phosphorylated tau, tau phosphorylated at threonine 181 (pTau181) was determined.|Baseline to Week 23 Day 2 for participants who received infusions every 2 weeks and Baseline to Week 21 Day 2 for participants who received infusions every 4 weeks|Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.||pg/mL||Standard Deviation|Mean
782273|NCT00812565|Secondary|Change From Baseline in Anti-Aβ Autoantibodies in Cerebral Spinal Fluid 24-48 Hours After the Last Infusion|Samples for determining anti-Aβ autoantibodies in blood plasma were processed at a central laboratory using a commercially available kit from DRG Instruments GmbH, (EIA-5099; Marburg, Germany) using methods established at the Department of Neurology, Philipps-University, Marburg, Germany (Professor Dr. med. Richard Dodel). The kit includes 6 standard concentrations of anti-Aβ antibody against which the results of the assay are compared. The standards contain 1, 5, 15, 30, 60, and 120 Relative Units (RTU) which contain 0.03, 0.17, 0.5, 1, 2, and 4 mg IgG/mL, respectively.|Baseline to Week 23 Day 2 for participants who received infusions every 2 weeks and Baseline to Week 21 Day 2 for participants who received infusions every 4 weeks|Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.||RTU||Standard Deviation|Mean
782274|NCT00812565|Secondary|Change From Baseline in Aβ1-40 and Aβ1-42 in Cerebral Spinal Fluid 24-48 Hours After the Last Infusion|Samples for determining Aβ1-40 and Aβ1-42 in cerebral spinal fluid were processed at a central laboratory using a commercially available kit from Meso Scale Discovery (MSD 96-Well Multi-Spot Human/Rodent (4G8) Abeta Triplex Ultra-Sensitive Assay; Rockville, MD, USA).|Baseline to Week 23 Day 2 for participants who received infusions every 2 weeks and Baseline to Week 21 Day 2 for participants who received infusions every 4 weeks|Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.||pg/mL||Standard Deviation|Mean
782275|NCT00812565|Secondary|Change in the Area Under the Curve of Plasma Anti-Aβ Autoantibodies in the 2 or 4 Weeks After the Last Treatment Infusion From the Trough Level Prior to the Last Treatment Infusion|For participants who received infusions every 2 weeks, plasma samples were collected at the trough level at Week 22 and on Days 1, 4, 7, and 14 after Week 22. For participants who received infusions every 4 weeks, plasma samples were collected at the trough level at Week 20 and on Days 1, 4, 7, 14, 21, and 28 after Week 20. Samples for determining anti-Aβ autoantibodies in blood plasma were processed at a central laboratory using a commercially available kit from DRG Instruments GmbH, (EIA-5099; Marburg, Germany) using methods established at the Department of Neurology, Philipps-University, Marburg, Germany (Professor Dr. med. Richard Dodel). The kit includes 6 standard concentrations of anti-Aβ antibody against which the results of the assay are compared. The standards contain 1, 5, 15, 30, 60, and 120 Relative Units (RTU) which contain 0.03, 0.17, 0.5, 1, 2, and 4 mg IgG/mL, respectively.|Week 22 to Week 24 for participants who received infusions every 2 weeks and Week 20 to Week 24 participants who received infusions every 4 weeks|Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.||RTU*days||Standard Deviation|Mean
782276|NCT00812565|Secondary|Change in the Area Under the Curve of Plasma Aβ1-42 in the 2 or 4 Weeks After the Last Treatment Infusion From the Trough Level Prior to the Last Treatment Infusion|For participants who received infusions every 2 weeks, plasma samples were collected at the trough level at Week 22 and on Days 1, 4, 7, and 14 after Week 22. For participants who received infusions every 4 weeks, plasma samples were collected at the trough level at Week 20 and on Days 1, 4, 7, 14, 21, and 28 after Week 20. Samples for determining Aβ1-42 in blood plasma were processed at a central laboratory using a commercially available kit from Innogenetics NV (INNO-BIA plasma Aβ forms; Gent, Belgium).|Week 22 to Week 24 for participants who received infusions every 2 weeks and Week 20 to Week 24 participants who received infusions every 4 weeks|Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.||(pg/mL)*days||Standard Deviation|Mean
782277|NCT00812565|Secondary|Change in Plasma Concentration of Anti-Aβ Autoantibodies From Baseline to the End of the Study (Week 24)|Samples for determining anti-Aβ autoantibodies in blood plasma were processed at a central laboratory using a commercially available kit from DRG Instruments GmbH, (EIA-5099; Marburg, Germany) using methods established at the Department of Neurology, Philipps-University, Marburg, Germany (Professor Dr. med. Richard Dodel). The kit includes 6 standard concentrations of anti-Aβ antibody against which the results of the assay are compared. The standards contain 1, 5, 15, 30, 60, and 120 Relative Units (RTU) which contain 0.03, 0.17, 0.5, 1, 2, and 4 mg IgG/mL, respectively.|Baseline to Week 24|Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.||RTU||Standard Deviation|Mean
782278|NCT00812565|Secondary|Change in Plasma Concentration of Aβ1-40 and Aβ1-42 From Baseline to the End of the Study (Week 24)|Samples for determining Aβ1-40 and Aβ1-42 in blood plasma were processed at a central laboratory using a commercially available kit from Innogenetics NV (INNO-BIA plasma Aβ forms; Gent, Belgium).|Baseline to Week 24|Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.||pg/mL||Standard Deviation|Mean
782279|NCT00812565|Primary|Change in the Area Under the Curve of Plasma Aβ1-40 in the 2 or 4 Weeks After the Last Treatment Infusion From the Trough Level Prior to the Last Treatment Infusion|For participants who received infusions every 2 weeks, plasma samples were collected at the trough level at Week 22 and on Days 1, 4, 7, and 14 after Week 22. For participants who received infusions every 4 weeks, plasma samples were collected at the trough level at Week 20 and on Days 1, 4, 7, 14, 21, and 28 after Week 20. Samples for determining Aβ1-40 in blood plasma were processed at a central laboratory using a commercially available kit from Innogenetics NV (INNO-BIA plasma Aβ forms; Gent, Belgium).|Week 22 to Week 24 for participants who received infusions every 2 weeks and Week 20 to Week 24 participants who received infusions every 4 weeks|Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.||(pg/mL)*days||Standard Deviation|Mean
782280|NCT00812604|Secondary|The Mandibular Function.|The mandibular function, the maximal comfortable mandibular opening measured in millimeters at the subjects's maximum incisor to incisor mouth opening using a ruler.|4 weeks|||mm||Standard Deviation|Mean
782281|NCT00812604|Primary|The Efficacy in the Treatment of TMJ and Muscle Pain|"The efficacy in the treatment of TMJ and muscle pain is measured by a visual analogue scale (VAS).
The VAS consists of a 100 mm line, anchored with the extremes of pain intensity represented as “no pain ( 0 mm) and  worst pain possible ( 100 mm)."|4 weeks|||units on a scale||Standard Deviation|Mean
782282|NCT00812812|Secondary|Plasma Paroxetine Concentrations at 12 Hours and 24 Hours After Administration of Study Drug at Week 8 or Withdrawal|Summary statistics for the plasma paroxetine concentrations at each time point were calculated by the dosage just before blood sampling using data from participants in whom plasma samples were collected at either 12 hours (plus or minus 2 hours) or 24 hours (plus or minus 2 hours) after the last administration of the study drug at Week 8 or Withdrawal (up to Week 8).|Week 8 or Withdrawal (up to Week 8)|All participants who received paroxetine and in whom plasma samples were collected at either 12 hours (plus or minus 2 hours) or 24 hours (plus or minus 2 hours) after the last administration of the study drug at Week 8 or Withdrawal (up to Week 8).||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
782283|NCT00812812|Secondary|Change From Baseline in the Clinical Global Impression - Severity of Illness (CGI-SI) Score at Weeks 1, 2, 3, 4, 6, and 8|CGI-SI is assessed on an 8-grade scale: 0, not assessed; 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; and 7, among the most extremely ill. CGI-SI was assessed by the investigator. The change from Baseline in CGI-SI score was calculated as the score at Weeks 1, 2, 3, 4, 6, and 8 minus the score at Baseline.|Baseline and Weeks 1, 2, 3, 4, 6, and 8|FAS. The analysis was performed on the OC dataset. Participants whose observation was missing at a particular visit were not included in the analysis for that week. The analysis of data at Week 8 was also performed on the LOCF dataset.||scores on a scale||Standard Deviation|Mean
782284|NCT00812812|Secondary|Number of Clinical Global Impression - Global Improvement (CGI-GI) Responders at Weeks 1, 2, 3, 4, 6, and 8|CGI-GI is assessed on an 8-grade scale: 0, not assessed; 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; and 7, very much worse. CGI-GI was assessed by the investigator. Participants who were rated as 1 (very much improved) or 2 (much improved) were categorized as CGI-GI responders.|Weeks 1, 2, 3, 4, 6, and 8|FAS. The analysis was performed on the OC dataset. Participants whose observation was missing at a particular visit were not included in the analysis for that week. The analysis of data at Week 8 was also performed on the LOCF dataset.||participants|||Number
782285|NCT00812812|Secondary|Change From Baseline in the CDRS-R Total Score at Weeks 1, 2, 3, 4, and 6|The CDRS-R has been widely used for the evaluation of children and adolescents with major depressive disorder (MDD). The CDRS-R total score is the sum of the responses to 17 questions. Each question is graded on a 5- or 7-point scale. The highest possible score is 113 (the most severe measure of depression), and the lowest is 17 (not suffering from depression). CDRS-R scores were assessed by the investigator. The change from Baseline in the CDRS-R total score was calculated as the total score at Week 8 minus the total score at Baseline. The data were adjusted with the total score at Baseline.|Baseline and Weeks 1, 2, 3, 4, and 6|FAS. The analysis was performed on the observed case (OC) dataset. Participants whose observation was missing at a particular visit were not included in the analysis for that week.||scores on a scale||Standard Error|Least Squares Mean
782301|NCT00812929|Secondary|Assessment of Hematology Parameters: Mean Corpuscle Hemoglobin (MCH)|Blood samples were collected for the assessment of hematology parameter for MCH at pre dose and 25 hours and 30 minutes post dose. Participants had to fast for at least 8 hours prior to visit. During treatment periods, fasting continued until a light meal was allowed 1 hour post dose.|Pre dose and 25 hours and 30 minutes post dose of each treatment period|All Subjects Population. Only those participants with data available at the indicated time points were analyzed||Picograms||Standard Deviation|Mean
785024|NCT00834626|Secondary|Percentage of Participants Showing Decrease in Requirement of Oral Anti-diabetic Agents|Percentage of participants showing decrease in requirement of oral anti-diabetic agents taken earlier for treatment of Type-2 Diabetes, assessed at one year|one year|||Percentage of Participants|||Number
782286|NCT00812812|Primary|Change From Baseline in the Children's Depression Rating Scale -Revised (CDRS-R) Total Score at Week 8|The CDRS-R has been widely used for the evaluation of children and adolescents with major depressive disorder (MDD). The CDRS-R total score is the sum of the responses to 17 questions. Each question is graded on a 5- or 7-point scale. The highest possible score is 113 (the most severe measure of depression), and the lowest is 17 (not suffering from depression). CDRS-R scores were assessed by the investigator. The change from Baseline in the CDRS-R total score was calculated as the total score at Week 8 minus the total score at Baseline. The data were adjusted with the total score at Baseline.|Baseline and Week 8|Full Analysis Set (FAS): all participants who entered the treatment phase, but excluding participants without the target indication, participants who received no tablet of the treatment phase medication, or participants who had no post-baseline CDRS-R data. The analysis was performed on the last observation carried forward (LOCF) dataset.||scores on a scale||Standard Error|Least Squares Mean
782287|NCT00812877|Secondary|Pulp Vitality|No evidence of pulpal resorption or calcification or periradicular radiolucency|Up to two years|||participants|||Number
782288|NCT00812877|Primary|Tooth Survival|No recommendation for tooth extraction or root canal therapy. Only one tooth was enrolled/assessed per participant.|Up to two years|12 subjects were excluded in the Mineral Trioxide Aggregate group due to lack of follow-up (4 subjects were non-responsive; unable to contact 6 subjects; 2 subjects changed dentists) and 6 subjects were in the Calcium Hydroxide group (2 subjects were non-responsive; unable to contact 3 subjects; 1 subject was incarcerated).||participants|||Number
782289|NCT00812916|Secondary|Total Number of Ablated Complex Fractionated Atrial Electrogram (CFAE) Discrete Points|Does not include 2 outliers with >300 CFAE discrete points. Based on the user-defined definition of a CFAE complex, the system identifies the number of intervals between adjacent CFAE complexes and the cycle length of these intervals. This makes it possible to estimate the number of CFAE complexes within certain amplitude and duration values. A CFAE complex is defined by the system based on the intervals between the peaks. Therefore, clinically, the CFAE software includes an algorithm that enables detection of CFAE complexes. The automatic detection and distribution of CFAE signals is taking place during a 2.5 second intra-cardiac ECG recording. When the CFAE areas are completely eliminated, but the arrhythmia continues as organized atrial flutter or atrial tachycardia, the atrial tachy-arrhythmias may be mapped and ablated upon discretion of the investigator. Analyses occur post-procedure.|Procedural|Safety population with non-outlier endpoint reported||points||Standard Deviation|Mean
782290|NCT00812916|Secondary|Total Fluoroscopy Time|Mean total fluoroscopy time|Procedural|Safety population with fluoroscopy time reported||minutes||Standard Deviation|Mean
782291|NCT00812916|Secondary|Total Radiofrequency (RF) Duration|Total duration of all radiofrequency applications with exception of 12 outliers recording >150 minutes.|Procedural|Safety population with RF data reported||minutes||Standard Deviation|Mean
782292|NCT00812916|Secondary|Total Complex Fractionated Atrial Electrogram (CFAE) Mapping Time|Total of left and right atrium CFAE mapping times with exception of 9 outliers reporting total CFAE mapping time of >120 minutes|Procedural|Safety population with mapping time reported||minutes||Standard Deviation|Mean
782293|NCT00812916|Secondary|Total Ablation Time|Total time of ablation with exception of 10 outliers with >180 minutes of total ablation time reported|Procedural|Safety population with ablation time reported||minutes||Standard Deviation|Mean
782294|NCT00812916|Primary|Acute Success|Sinus rhythm achieved at end of ablation procedure without electrical or pharmaceutical cardioversion|End of procedure|Patients with CFAE-guided RF catheter ablation||percentage achieving success||95% Confidence Interval|Number
782295|NCT00812929|Secondary|Derived Pharmacokinetic (PK) Parameters for GSK2190915|PK samples were supposed to be collected at 10 minutes prior to the exercise challenge at 2 hours, 9.5 hours and 24 hours.|Pre dose, 2 hours, 3.5 hours, 9.5 hours, 11 hours and 24 hours following exercise challenge of each treatment period|PK Population was defined as participants in the ‘All Subjects’ Population for whom a PK sample was obtained and analyzed. Data was not collected for this outcome measure.|||||
782296|NCT00812929|Secondary|Percentage Change From Baseline in Urine Leukotriene E4 (LTE4)|Analysis of LTE4 levels in the urine samples indicated the extent of LTE4 inhibition following administration of GSK2190915 compared to Baseline. Baseline was the pre dose value. Change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.|Baseline (pre dose) up to 24 Hours post dose of each treatment period|PD Population. Only those participants available at the indicated time points were analyzed.||Percent change||Full Range|Median
782297|NCT00812929|Secondary|Percentage Change From Baseline in Blood Leukotriene B4 (LTB4)|Analysis LTB4 levels in the blood samples indicated the extent of LTB4 inhibition following administration of GSK2190915 compared to Baseline. Baseline was the pre dose value. Change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.|Baseline (pre dose) up to 24 Hours post dose of each treatment period|Pharmacodynamics (PD) Population was defined as participants in the ‘All Subjects’ Population for whom a PD sample (blood or urine) was obtained and analyzed. Only those participants available at the indicated time points were analyzed.||Percent change||Full Range|Median
782298|NCT00812929|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect and medically significant.|Up to follow up (7 to 21 days) following last dose|All Subjects Population.||Participants|||Count of Participants
782299|NCT00812929|Secondary|Assessment of Hematology Parameters: Red Blood Cell Count (RBC)|Blood samples were collected for the assessment of hematology parameter for RBC at pre dose and 25 hours and 30 minutes post dose. Participants had to fast for at least 8 hours prior to visit. During treatment periods, fasting continued until a light meal was allowed 1 hour post dose.|Pre dose and 25 hours and 30 minutes post dose of each treatment period|All Subjects Population. Only those participants with data available at the indicated time points were analyzed.||Cells x 10^12 per liter||Standard Deviation|Mean
782946|NCT00815659|Secondary|Interleukin 8 (IL-8) Level After 3 Months of Rosuvastatin Treatment|IL-8 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF (Last Observation Carried Forward) IL-8 levels of participants||pg/mL||Standard Deviation|Mean
782302|NCT00812929|Secondary|Assessment of Hematology Parameters: Hematocrit|Blood samples were collected for the assessment of hematology parameters for hematocrit at pre dose and 25 hours and 30 minutes post dose. Participants had to fast for at least 8 hours prior to visit. During treatment periods, fasting continued until a light meal was allowed 1 hour post dose.|Pre dose and 25 hours and 30 minutes post dose of each treatment period|All Subjects Population. Only those participants with data available at the indicated time points were analyzed.||Ratio||Standard Deviation|Mean
782303|NCT00812929|Secondary|Assessment of Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC)|Blood samples were collected for the assessment of hematology parameters for hemoglobin and MCHC at pre dose and 25 hours and 30 minutes post dose. Participants had to fast for at least 8 hours prior to visit. During treatment periods, fasting continued until a light meal was allowed 1 hour post dose.|Pre dose and 25 hours and 30 minutes post dose of each treatment period|All Subjects Population. Only those participants with data available at the indicated time points were analyzed.||G/L||Standard Deviation|Mean
782304|NCT00812929|Secondary|Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC)|Blood samples were collected for the assessment of hematology parameters for basophils, eosinophils, lymphocytes, monocytes, TN, platelet count, WBC at pre dose and 25 hours and 30 minutes post dose. Participants had to fast for at least 8 hours prior to visit. During treatment periods, fasting continued until a light meal was allowed 1 hour post dose.|Pre dose and 25 hours and 30 minutes post dose of each treatment period|All Subjects Population. Only those participants with data available at the indicated time points were analyzed.||Cells x 10^9 per liter||Standard Deviation|Mean
782305|NCT00812929|Secondary|Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN)|Blood samples were collected for the assessment of clinical chemistry parameters for calcium, chloride, glucose, potassium, sodium and urea/BUN at pre dose and 25 hours and 30 minutes post dose. Participants had to fast for at least 8 hours prior to visit. Participants fasted for glucose blood sample. During treatment periods, fasting continued until a light meal was allowed 1 hour post dose.|Pre dose and 25 hours and 30 minutes post dose of each treatment period|All Subjects Population. Only those participants with data available at the indicated time points were analyzed.||Millimole per liter (mmol/L)||Standard Deviation|Mean
782306|NCT00812929|Secondary|Assessment of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine|Blood samples were collected for the assessment of clinical chemistry parameters for direct bilirubin, total bilirubin and creatinine at pre dose and 25 hours and 30 minutes. Participants had to fast for at least 8 hours prior to visit. During treatment periods, fasting continued until a light meal was allowed 1 hour post dose.|Pre dose and 25 hours and 30 minutes post dose of each treatment period|All Subjects Population. Only those participants available at the indicated time points were analyzed.||Micromoles per liter (µmol/L)||Standard Deviation|Mean
782307|NCT00812929|Secondary|Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT)|Blood samples were collected for the assessment of clinical chemistry parameters for ALP, ALT, AST and GGT at pre dose and 25 hours and 30 minutes. Participants had to fast for at least 8 hours prior to visit. During treatment periods, fasting continued until a light meal was allowed 1 hour post dose.|Pre dose and 25 hours and 30 minutes post dose of each treatment period|All Subjects Population. Only those participants available at the indicated time points were analyzed.||International units per liter (IU/L)||Standard Deviation|Mean
782308|NCT00812929|Secondary|Assessment of Clinical Chemistry Parameters: Albumin, Total Protein|Blood samples were collected for the assessment of clinical chemistry parameters for albumin and total protein at pre dose and 25 hours and 30 minutes. Participants had to fast for at least 8 hours prior to visit. During treatment periods, fasting continued until a light meal was allowed 1 hour post dose.|Pre dose and 25 hours and 30 minutes post dose of each treatment period|All Subjects Population. Only those participants with data available at the indicated time points were analyzed.||Gram/liter (G/L)||Standard Deviation|Mean
782309|NCT00812929|Secondary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings|All participants rested for at least 10 minutes in the supine position prior to ECG recordings. ECG Baseline values for each treatment period was calculated using the mean value of triplicate pre dose readings. Triplicate readings were taken at least five minutes apart. Assessment was performed at pre dose, 2 hours, 9.5 hours, 24 hours prior to exercise challenge and 60 minutes following exercise challenge at 2 hours. Participants with not clinically significant (NCS) abnormal values were reported. Potential clinical importance range for the ECG parameters are as follows: absolute QTc interval >450 millisecond (msec), increase from Baseline QTc >60 msec, PR interval <110 and >220 msec and QRS interval <75 and >110 msec. No participants reported clinically significant abnormal values.|Pre dose, 2 hours, 9.5 hours and 24 hours prior to exercise challenge and 60 minutes following exercise challenge at 2 hours of each treatment period|All Subjects Population.||Participants|||Count of Participants
782310|NCT00812929|Secondary|Assessment of Vital Signs: Heart Rate (HR)|All participants rested for at least 10 minutes in the supine position prior to vital signs recordings. Vital signs Baseline values for HR for each treatment period were calculated using the mean value of triplicate pre dose readings. Triplicate readings were taken at least five minutes apart. Assessment was performed at pre dose, 2 hours, 9.5 hours and 24 hours prior to exercise challenge.|Pre dose, 2 hours, 9.5 hours and 24 hours prior to exercise challenge of each treatment period|All Subjects Population.||Beats per minute||Standard Deviation|Mean
782311|NCT00812929|Secondary|Assessment of Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|All participants rested for at least 10 minutes in the supine position prior to vital signs recordings. Vital signs Baseline values for SBP and DBP for each treatment period were calculated using the mean value of triplicate pre dose readings. Triplicate readings were taken at least five minutes apart. Assessment was performed at pre dose, 2 hours, 9.5 hours and 24 hours prior to exercise challenge.|Pre dose, 2 hours, 9.5 hours and 24 hours prior to exercise challenge of treatment period|All Subjects Population was defined as all participants who received at least one dose of study medication.||Millimeters of mercury (mmHg)||Standard Deviation|Mean
782524|NCT00805935|Secondary|Percentage of Participants With Clinical Pregnancy at Week 7|Clinical pregnancy is the confirmation of the presence of intrauterine gestational sacs on pregnancy ultrasound examination.|approximately Day 52|Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication||Percentage of participants|||Number
782312|NCT00812929|Secondary|Number of Participants Using a Short Acting Beta-2 Agonist (Rescue Medication) During 0 to 90 Minutes Following Exercise Challenge|Rescue medication was provided to participants at any time and it was strongly recommended for participants with a FEV1 decrease of at least 40% following exercise challenge compared to Baseline. Rescue medication was administered 0 to 90 minutes post exercise challenge. Statistical analysis was supposed to be performed using logistic regression, however, the data was too sparse to permit any formal statistical analysis.|0 to 90 minutes following exercise challenge of each treatment period|Efficacy Population.||Participants|||Count of Participants
782313|NCT00812929|Secondary|Time to FEV1 Recovery to Within 5 Percent of Baseline Following Exercise Challenge|"The time from maximal percentage change in FEV1 to recovery to within 5% of pre challenge Baseline (in minutes) was derived using actual sampling times. Time to FEV1 recovery= [SAS date/time of recovery(a) FEV1 – SAS date/time of FEV1 Maximum % Change0-60] / 60, where a is earliest recorded FEV1 either above pre-challenge Baseline or within 5% below pre challenge Baseline. Any unscheduled FEV1 measurements taken after last scheduled post challenge measurement was considered when deriving this endpoint. A corresponding censoring variable was derived for analysis to indicate whether recovery to within 5% of pre-challenge Baseline was achieved. The censoring variable was set to 1 if recovery to within 5% of Baseline was achieved. If recovery was not evident from data collected, time to recovery was calculated using the date/time of the last available post challenge FEV1 assessment and censoring variable was set to zero. Analysis was performed using a Cox proportional hazards model."|0 to 60 minutes following exercise challenge at 2, 9.5 and 24 hours post dose of each treatment period|Efficacy Population.||Minutes||95% Confidence Interval|Median
782314|NCT00812929|Secondary|Weighted Mean (WM) for FEV1 Percentage Change From Baseline Recorded During 0 to 60 Minutes Following Exercise Challenge (FEV1 WM0-60)|FEV1 was recorded in triplicate, with participant encouraged to inhale fully despite any presence of chest tightness. For FEV1, a pre-challenge Baseline was defined for each challenge time point as maximum of triplicate measurements performed prior to challenge.Weighted mean FEV1 percentage change recorded during 0-60 minutes post challenge was determined for each challenge, by dividing area under curve (AUC) for percent change from Baseline FEV1 measurements at 5, 10, 15, 30, 45 and 60 minutes post challenge by time interval. Actual times were used to determine time interval where available; otherwise planned relative time was used. If one or more FEV1 values were missing, AUC was calculated over time interval of available values. If intermittent values were missing over a participant’s profile,it was assumed to be linear between 2 available values for calculation of AUC. Analysis was performed using a mixed effects model, including period, treatment and covariates for predose FEV1.|Baseline (pre dose) and 0 to 60 minutes following exercise challenge at 2, 9.5 and 24 hours post dose of each treatment period.|Efficacy Population.||Percent change||Standard Error|Least Squares Mean
782315|NCT00812929|Secondary|Maximal Percentage Change From Pre-exercise Baseline FEV1 to the Minimum FEV1 Collected Within 60 Minutes Following the Exercise Challenge at 2 and 9.5 Hours Post Dose|FEV1 was recorded in triplicate, with participant encouraged to inhale fully despite any presence of chest tightness. For FEV1, a pre-challenge Baseline was defined for each challenge time point as maximum of triplicate measurements performed prior to challenge. The maximal percentage change within 60 minutes following exercise challenge was derived by taking minimum percentage change in FEV1 over 5, 10, 15, 30, 45 and 60 minutes post challenge. Percent change FEV1 = 100*(FEV1 – Pre-challenge FEV1)/ Pre-challenge FEV1. If the exercise challenge was not completed successfully (i.e. heart rate maintained at >=80% of the predicted value for 6 minutes), the FEV1 maximal percent change (0-60)was set to be missing. Analysis was performed using a mixed effects model, including period, treatment and covariates for predose FEV1. Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|Baseline (pre dose) and 60 minutes following the exercise challenge at 2 and 9.5 hours post dose of each treatment period.|Efficacy Population.||Percent change||Standard Error|Least Squares Mean
782316|NCT00812929|Primary|Maximal Percentage Change From Pre-exercise Baseline Forced Expiratory Volume in 1 Second (FEV1) to the Minimum FEV1 Collected Within 60 Minutes Following the Exercise Challenge at 24 Hours Post Dose|FEV1 was recorded in triplicate, with participant encouraged to inhale fully despite any presence of chest tightness. For FEV1, a pre-challenge Baseline was defined for each challenge time point as maximum of triplicate measurements performed prior to challenge. The maximal percentage change within 60 minutes following exercise challenge was derived by taking minimum (i.e., most negative) percentage change in FEV1 over 5, 10, 15, 30, 45 and 60 minutes post challenge. Percent change FEV1 = 100*(FEV1 – Pre-challenge FEV1)/ Pre-challenge FEV1. If the exercise challenge was not completed successfully (i.e. heart rate maintained at >=80% of the predicted value for 6 minutes), FEV1 maximal percent change (0-60)was set to be missing. Analysis was performed using a mixed effects model, including period, treatment and covariates for predose FEV1. Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|Baseline (pre dose) and 60 minutes following the exercise challenge at 24 hours post dose of each treatment period.|The ‘Efficacy Population’ was defined as all participants who received at least one dose of study medication and are not major protocol violators.||Percent change||Standard Error|Least Squares Mean
782317|NCT00812955|Other Pre-specified|Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to the Final Visit (Full Analysis Set)|The ABT-143 capsules 20/135 milligram, ABT-143 capsules 10/135 milligram, and ABT-143 capsules 5/135 milligram groups were compared to the simvastatin capsules 40 milligram group for mean percent change in high-density lipoprotein cholesterol from Baseline to the Final Visit for the full analysis set.|Baseline to 8 weeks|Full Analysis Set was used and defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for HDL-C. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.||percent change||Standard Error|Mean
782329|NCT00812968|Secondary|Duration of Erythroid Response|Duration of erythroid response was calculated as the time from the start of the first major or minor erythroid response to the end of the response. Similarly, duration of major erythroid response was calculated as the time from the start of the first major erythroid response to the end of the response. Response duration was censored at the last adequate assessment for patients who maintained response.|From the first dose of study drug through Week 156|Efficacy population with a erythroid response||weeks||95% Confidence Interval|Median
782318|NCT00812955|Other Pre-specified|Median Percent Change in Triglycerides From Baseline to the Final Visit (Full Analysis Set)|The ABT-143 capsules 20/135 milligram, ABT-143 capsules 10/135 milligram, and ABT-143 capsules 5/135 milligram groups were compared to the simvastatin capsules 40 milligram group for median percent change in triglycerides from Baseline to the Final Visit for the full analysis set.|Baseline to 8 weeks|Full Analysis Set was used and defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for triglycerides. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.||percent change||Inter-Quartile Range|Median
782319|NCT00812955|Secondary|Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C), With ABT-143 Capsules 5/135 Milligrams Versus Simvastatin Capsules 40 Milligrams (Full Analysis Set)|The mean percent change from Baseline to the Final Visit in low-density lipoprotein cholesterol, comparing the following treatment groups, ABT-143 capsules 5/135 milligrams versus simvastatin capsules 40 milligrams for the full analysis set.|Baseline to 8 weeks|Full Analysis Set was used and defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for LDL-C. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.||percent change||Standard Error|Mean
782320|NCT00812955|Secondary|Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C), With ABT-143 Capsules 10/135 Milligrams Versus Simvastatin Capsules 40 Milligrams (Full Analysis Set)|The mean percent change from Baseline to the Final Visit in low-density lipoprotein cholesterol, comparing the following treatment groups, ABT-143 capsules 10/135 milligrams versus simvastatin capsules 40 milligrams for the full analysis set.|Baseline to 8 weeks|Full Analysis Set was used and defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for LDL-C. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.||percent change||Standard Error|Mean
782321|NCT00812955|Primary|Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C) (Full Analysis Set)|"The mean percent change from Baseline to the Final Visit in low-density lipoprotein cholesterol, comparing the following two treatment groups:
ABT-143 capsules 20/135 milligrams versus simvastatin capsules 40 milligrams for the full analysis set."|Baseline to 8 weeks|Full Analysis Set was used and defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for LDL-C. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.||percent change||Standard Error|Mean
782322|NCT00812968|Secondary|Percentage of Bone Marrow Promyelocytes|Bone marrow morphology was assessed by the central hematologic reviewers based on the locally-prepared bone marrow smear slide and clot section.|Baseline, at the end of Cycle 3 (Day 85) and Cycle 6 (Day 169).|"Efficacy population with available bone marrow specimens at each time point (indicated by N)."||Percentage of promyelocytes||Full Range|Median
782323|NCT00812968|Secondary|Percentage of Bone Marrow Myeloblasts|Bone marrow morphology was assessed by the central hematologic reviewers based on the locally-prepared bone marrow smear slide and clot section.|Baseline, at the end of Cycle 3 (Day 85) and Cycle 6 (Day 169).|"Efficacy population with available bone marrow specimens at each time point (indicated by N)."||Percentage of myeloblasts||Full Range|Median
782324|NCT00812968|Secondary|Change From Baseline in Percentage of Bone Marrow Erythroblasts|Bone marrow morphology was assessed by the central hematologic reviewers based on the locally-prepared bone marrow smear slide and clot section.|Baseline, at the end of Cycle 3 (Day 85) and Cycle 6 (Day 169).|Efficacy population with available bone marrow specimens.||Percentage of Bone Marrow Erythroblasts||Full Range|Median
782325|NCT00812968|Secondary|Number of Participants With a Cytogenetic Response|"Cytogenetic (chromosome structure) abnormalities were assessed by a central cytogenetic reviewer based on prints and cytogenetic reports of the bone marrow sample from the central laboratory. Cytogenetic response was determined using the IWG (2000) criteria and categorized as either a major response or minor response. Twenty metaphases were analyzed for the determination of cytogenetic response.
A major response was defined as no detectable cytogenetic abnormality, if an abnormality was present at Baseline, sustained for consecutive 56 days during the treatment period. A minor response was defined as ≥ 50% reduction from Baseline in abnormal metaphases sustained for consecutive 56 days during the treatment period."|Response was assessed every 12 weeks through Week 156|Efficacy population||participants|||Number
782326|NCT00812968|Secondary|Number of Participants With a Platelet Response|"Platelet response was determined using the IWG (2000) criteria. Major response in patients with Baseline platelet count < 100,000/mm^3 is defined as a ≥ 30,000/mm^3 increase sustained for consecutive 56 days during the treatment period. In platelet-transfusion-dependent patients at Baseline a major response is defined as stabilization of platelet counts and platelet transfusion independence sustained for consecutive 56 days during the treatment period.
Minor response in patients with Baseline platelet count < 100,000/mm^3 is defined as a ≥ 50% increase in platelet count with an absolute increase > 10,000/mm^3 and < 30,000/mm^3 sustained for consecutive 56 days during the treatment period."|Response was assessed every 28 days through Week 156|Efficacy population with a Baseline platelet count of < 100,000/mm^3 or who were platelet-transfusion dependent at Baseline. There were no patients with platelet count of < 100,000/mm3 or who were platelet-transfusion dependent at Baseline, and thus platelet response was not evaluated.|||||
782327|NCT00812968|Secondary|Number of Participants With a Neutrophil Response|"Neutrophil response was determined using the IWG (2000) criteria. A major response for participants with a Baseline neutrophil count < 1,500/mm^3 is defined as a ≥ 100% increase or a ≥ 500/mm^3 increase, whichever is greater, sustained for consecutive 56 days during the treatment period.
A minor response for participants with a Baseline neutrophil count < 1,500/mm^3 is defined as a ≥ 100% increase, but an absolute increase < 500/mm^3, sustained for consecutive 56 days during the treatment period."|Response was assessed every 28 days through Week 156|Efficacy population with Baseline neutrophil count < 1,500/mm^3.||participants|||Number
782328|NCT00812968|Secondary|Change From Baseline in Hemoglobin Concentration|Change in hemoglobin concentration from Baseline to the maximum observed value during the major erythroid response period for major erythroid responders.|Baseline and from Day1 until the maximum observed value (up to 155 weeks)|Efficacy population with a erythroid response||g/dL||Full Range|Median
782330|NCT00812968|Secondary|Time to Erythroid Response|Time to erythroid response was calculated as the time from the first dose of study drug to the start of the first major or minor erythroid response. Similarly, time to major erythroid response was calculated as the time from the first dose of study drug to the start of the first major erythroid response.|From the first dose of study drug through Week 156|Efficacy population||weeks||Full Range|Median
782331|NCT00812968|Secondary|Number of Participants With a Erythroid Response|"Erythroid response was determined using the International Working Group (IWG) 2000 criteria, categorized as a major response or minor response.
A major response in patients with transfusion-dependent anemia (receiving ≥ 4.5 units of red blood cell (RBC) transfusion during 56 consecutive days at Baseline) is defined as RBC transfusion independence accompanied by a ≥1.0 g/dL increase from Baseline in hemoglobin sustained for 56 days consecutively during the treatment period. In patients with transfusion-independent anemia with hemoglobin < 10 g/dL at Baseline a major response is defined as a > 2.0 g/dL increase from Baseline in hemoglobin sustained for consecutive 56 days.
Minor response in patients with transfusion-dependent anemia defined as ≥ 50% decrease from Baseline in transfusion requirements sustained for consecutive 56 days, and in transfusion-independent patients as 1.0 to 2.0 g/dL increase from Baseline in hemoglobin sustained for consecutive 56 days."|Response was assessed every 28 days through Week 156.|Efficacy population: all patients who had a diagnosis of low- or intermediate-1-risk MDS associated with anemia based on confirmation by the central reviewers and received at least 1 dose of study drug.||participants|||Number
782332|NCT00812968|Secondary|Apparent Terminal Elimination Rate Constant of Lenalidomide|Apparent terminal elimination rate constant of lenalidomide determined after a single dose on Day 1 and multiple doses (Day 4).|Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.|PK population with available data||1/h||Geometric Coefficient of Variation|Geometric Mean
782333|NCT00812968|Secondary|Apparent Total Plasma Clearance (CL/F) of Lenalidomide|Apparent total plasma clearance (CL/F) of lenalidomide after a single dose on Day 1 and multiple doses (Day 4).|Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.|PK population with available data||mL/minute||Geometric Coefficient of Variation|Geometric Mean
782334|NCT00812968|Secondary|Apparent Volume of Distribution (VzF) of Lenalidomide|Apparent volume of distribution of lenalidomide after a single dose on Day 1 and multiple doses (Day 4).|Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.|PK population with available data||liters||Geometric Coefficient of Variation|Geometric Mean
782335|NCT00812968|Secondary|Terminal Half-life (T1/2) of Lenalidomide|The apparent terminal half-life is the time required for plasma concentration to decrease by 50% after pseudo-equilibrium of distribution has been reached, and calculated as the natural logarithm of 2 (0.693) / Apparent terminal rate constant (λz).|Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.|PK population with available data||hours||Geometric Coefficient of Variation|Geometric Mean
782336|NCT00812968|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC∞) of Lenalidomide|Area under the plasma concentration-time curve from time zero to infinity (AUC∞) of lenalidomide after a single dose on Day 1.|Day 1 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12 and 24 hours post-dose.|PK population with available data||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
782337|NCT00812968|Secondary|Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUCτ) of Lenalidomide|Area under the plasma concentration-time curve over the dosing interval (AUCτ) of lenalidomide after a single dose on Day 1 and multiple doses (Day 4).|Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12 and 24 hours post-dose.|PK population with available data||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
782338|NCT00812968|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUCt) of Lenalidomide|Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUCt) of lenalidomide after a single dose on Day 1 and multiple doses (Day 4).|Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.|PK population||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
782339|NCT00812968|Secondary|Time to Maximum Plasma Concentration (Tmax) of Lenalidomide|Time to maximum observed plasma concentration of lenalidomide after a single dose on Day 1 and multiple doses (Day 4).|Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.|PK population||hours||Full Range|Median
782340|NCT00812968|Secondary|Maximum Observed Plasma Concentration (Cmax) of Lenalidomide|Maximum observed plasma concentration of lenalidomide after a single dose on Day and after multiple doses (Day 4).|Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.|Pharmacokinetic (PK) population: all patients who adhered to the study treatment during the course of PK assessment (Days 1 to 5 of Cycle 1) and from whom blood and urine samples were collected.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
782341|NCT00812968|Primary|Number of Participants With Adverse Events (AE)|"An AE that resulted in any of the following outcomes was defined as a serious adverse event (SAE):
Death;
Life-threatening event;
Any inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability or incapacity;
Congenital anomaly or birth defect;
Any other important medical event.
The investigator determined the relationship of an AE to study drug based on the timing of the AE relative to drug administration and whether or not other drugs, therapeutic interventions, or underlying conditions could provide a sufficient explanation for the event.
The severity of an AE was evaluated by the investigator according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (Version 3.0) where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death."|After the first study dose until 28 days after completion of/discontinuation from the study (maximum time on study was 155 weeks).|Safety population: all patients who received at least 1 dose of study drug.||participants|||Number
782342|NCT00812981|Secondary|Number of Subjects With SAEs|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Day 0 up to Day 180)|The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects for whom safety data were available.||Participants|||Count of Participants
782657|NCT00806819|Secondary|Overall Survival (Key Secondary Endpoint)|Overall Survival (OS) defined as the duration from randomisation to death (irrespective of the reason of death). Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.|From randomisation until data cut-off (15 February 2013), Up to 30 months|RS||months||Inter-Quartile Range|Median
782343|NCT00812981|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Day 0 up to Day 51|The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects for whom safety data were available.||Participants|||Count of Participants
782344|NCT00812981|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the entire study period (from Day 0 up to Day 180)|The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects for whom safety data were available.||Participants|||Count of Participants
782345|NCT00812981|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 21-day follow-up period after the first vaccination and 30-day follow-up period after the second vaccination|The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects for whom safety data were available.||Participants|||Count of Participants
782346|NCT00812981|Secondary|Number of Subjects With Any AESIs|An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.|During the entire study period (from Day 0 up to Day 180)|The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects for whom safety data were available.||Participants|||Count of Participants
782347|NCT00812981|Secondary|Number of Subjects With Any Adverse Events of Specific Interest (AESIs)|An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.|From Day 0 up to 51 days after the first vaccination|The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects for whom safety data were available.||Participants|||Count of Participants
782348|NCT00812981|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, headache, myalgia, shivering, sweating and fever [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as causally related to the study vaccination.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom safety data were available and who had the symptom sheet filled in.||Participants|||Count of Participants
782349|NCT00812981|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom safety data were available and who had the symptom sheet filled in.||Participants|||Count of Participants
782350|NCT00812981|Secondary|Number of Seroconverted Subjects for Neutralizing Antibodies|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:28 and a post-vaccination titer ≥ 1:56 or a pre-vaccination titer ≥ 1:28 and at least a four-fold increase in post-vaccination titer. The flu strain assessed was A/Vietnam/1194/2004.|At Day 42 and Day 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.||Subjects|||Number
782351|NCT00812981|Secondary|Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value|Seropositivity cut-off values assessed were equal to or above (≥) 1:28 in the sera of subjects seronegative before vaccination. The flu strain assessed was A/Vietnam/1194/2004.|At Days 0, 42 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.||Subjects|||Number
782352|NCT00812981|Secondary|Titers for Serum Neutralising Antibodies Against A/Vietnam/1194/2004 Strain of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:28. The flu strain assessed was A/Vietnam/1194/2004.|At Days 0, 42 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.||Titers||95% Confidence Interval|Geometric Mean
782353|NCT00812981|Secondary|Number of Seroprotected Subjects for H5N1 HI Antibodies|A seroprotected subject was defined as a vaccinated subject with a serum HI titer equal to or above (≥) 1:40. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.|At Days 0, 42 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.||Subjects|||Number
782354|NCT00812981|Secondary|Seroconversion Factor (SCF) for H5N1 HI Antibodies|The seroconversion factor (SCF) was defined as the fold increase in H5N1 HI antibody GMTs post-vaccination compared to Day 0. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.|At Day 42 and Day 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.||Fold change||95% Confidence Interval|Geometric Mean
782355|NCT00812981|Secondary|Number of Seroconverted Subjects Against Two Strains of Influenza Disease|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer below (<) 1:10 and a post-vaccination titer equal to or above (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.|At Day 42 and Day 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.||Subjects|||Number
782356|NCT00812981|Secondary|Number of Subjects With H5N1 HI Antibody Concentrations Above the Cut-off Value|The cut-off values for the humoral immune response in terms of H5N1 HI antibodies were equal to or above (≥) 1:10. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.|At Days 0, 42 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.||Subjects|||Number
782357|NCT00812981|Secondary|Titers for Serum H5N1 HI Antibodies|Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.|At Day 0 and Day 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.||Titers||95% Confidence Interval|Geometric Mean
782358|NCT00812981|Primary|Titers for Serum H5N1 Haemagglutination-inhibition (HI) Antibodies|Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was A/Indonesia/05/2005.|At Day 42|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.||Titers||95% Confidence Interval|Geometric Mean
782359|NCT00813098|Secondary|Change From Baseline at Week 4 on the Global Improvement Score.|"The IBS Global Improvement Scale (IBS-GAI) asks Compared to the way you felt before you entered the study, have your IBS symptoms over the past 7 days been: 1-substantially worse, 2-moderately worse, 3-slightly worse, 4-no change, 5-slightly improved, 6-moderately improved, 7-substantially improved? The mean score for Week 4 was subtracted from the mean baseline score to obtain the mean change from baseline on the Global Improvement Score."|Baseline to Week 4|Per protocol population; Last observation carried forward.||Score on a scale||Standard Deviation|Mean
782360|NCT00813098|Secondary|Change From Baseline at Week 4 on the Severity of Bloating|"Subjects recorded in the daily diary the level of bloating they felt on a daily basis using a 100 mm visual analog scale (with 0 being not at all and 100 mm being worst possible). The mean score for Week 4 was subtracted from the baseline mean score to obtain the mean change from baseline in severity of bloating."|Baseline to Week 4|Per protocol population; Last observation carried forward.||Score on a scale||Standard Deviation|Mean
782361|NCT00813098|Secondary|Change From Baseline at Week 4 in Stool Frequency|Subjects recorded the number of times they passed stool on a daily basis in the daily diary. The mean for Week 4 was subtracted from the baseline mean to obtain the mean change from baseline in stool frequency.|Baseline to Week 4|Per protocol population; Last observation carried forward.||Number of daily stools||Standard Deviation|Mean
782362|NCT00813098|Secondary|Change From Baseline at Week 4 in Stool Consistency Scores|Stool consistency was evaluated using the 7-point Bristol Stool Scale in which a score of 1 indicates separate hard lumps, 2 indicates sausage shaped but lumpy, 3 indicates sausage-like with cracks on the surface, 4 indicates sausage-like but smooth and soft, 5 indicates soft blobs with clear cut edges, 6 indicates fluffy pieces with ragged edges, and 7 indicates watery with no solid pieces. The mean score for Week 4 was subtracted from the baseline mean score to obtain the mean change from baseline.|Baseline to Week 4|Per protocol population; Last observation carried forward.||Score on a scale||Standard Deviation|Mean
782363|NCT00813098|Secondary|Change From Baseline at Week 4 in Proportion of Days Per Week When Experiencing Urgency to Defecate|"To assess sensation of urgency to defecate on a daily basis, subjects recorded in their daily diary a response to the following question,Have you felt or experienced a sense of urgency to pass stool today? The mean score (proportion of days per week when the subject experienced an urge to defecate) for Week 4 was subtracted from the baseline mean score to determine the mean change from baseline."|Baseline to Week 4|Per protocol population; Last observation carried forward.||Score on a scale||Standard Deviation|Mean
782364|NCT00813098|Primary|Subjects Who Experienced Relief of IBS Pain and Discomfort at Week 4|"The primary efficacy endpoint was the proportion of subjects experiencing relief of IBS pain and discomfort at Week 4 as measured by the response to the question,In the past 7 days have you had adequate relief of your irritable bowel syndrome pain and discomfort?"|Week 4|Per protocol population; Last observation carried forward.||Participants|||Number
782365|NCT00813111|Secondary|Number of Participants With Adverse Events||30 days||||||
782366|NCT00813111|Primary|Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) With Activity (NRS-A) Pain Intensity Scores|"Assessments of postoperative pain included pain intensity at rest (using the NRS at rest [NRS-R] and with activity [using the NRS-A]) where the prescribed activity was raising both arms.
Pain intensity was assessed on a scale of 0 to 10, where 0=no pain and 10=worst possible pain."|through 72 hours|Note: 136 subjects were randomized and received study drug and were included in the analyses. 10 subjects were randomized but not dosed and 4 additional subjects failed screening, resulting in 122 subjects.||Units on a scale*hours||Standard Deviation|Mean
782367|NCT00813150|Secondary|Overall Response Rate (ORR) - International Myeloma Working Group (IMWG) Response Criteria|Percentage of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR) is reported in the below table. IMWG criteria- CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow; sCR: CR+Normal free light chain ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescencec; PR: ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90%; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100mg per 24 hour.|Up to 46 days after last bortezomib dose, or as soon as possible after early discontinuation of study treatment or before start of alternative anti-myeloma therapy|Intent-to-treat (ITT): Participants who received at least one dose of study medication and in whom the primary efficacy parameter could be assessed at least once under study medication.||Percentage of participants|||Number
782369|NCT00813150|Secondary|Progression-Free Survival (PFS)|PFS is defined as time from randomization to myeloma progression according to International Myeloma Working Group (IMWG) criteria or death from any cause. IMWG criteria: increase of ≥25 percent from lowest response level in Serum M-component and/or (the absolute increase must be ≥0.5 g/dL) Urine M-component and/or (the absolute increase must be ≥200 mg/24 hour. Only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain levels. The absolute increase must be >10 mg/dL. Bone marrow plasma cell percentage: the absolute percent must be ≥10 percent. Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas. Development of hypercalcemia (corrected serum calcium >11.5 mg/dL or 2.65mmol/L) that can be attributed solely to the plasma cell proliferative disorder. PFS included disease progression as well as death.|From the date of randomization until the disease progression or participant's death from any cause whichever occured first, as assessed up to 72 weeks after end of treatment visit (ie, 46 days after last dose of study medication)|Intent-to-treat (ITT): all participants who received at least one dose of study medication and in whom the primary efficacy parameter could be assessed at least once under study medication. Participants without progression and who are still alive at the end of the study or dropped out will be censored with the last available date.||Months||95% Confidence Interval|Median
782370|NCT00813150|Primary|Time to Progression of Disease|’Median time to progression of disease is assessed according to International Myeloma Working Group (IMWG) criteria or death from any cause. IMWG criteria: increase of >=25% from lowest level in Serum M-component or (the absolute increase must be >=0.5 gram per deciliter [g/dL]); Urine M component or (the absolute increase must be >=200 milligram per 24 hour. Only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain levels. The absolute increase >10 mg/dL. Bone marrow plasma cell percentage >=10%. Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing. Development of hypercalcemia. Participants who died or dropped out due to any reason without progression will be censored with the day of death or drop-out, respectively and who are alive at the end of the study without any progression was censored with the last available date.|From the date of randomization until the disease progression or participant's death from any cause whichever occurred first, as assessed up to 72 weeks after end of treatment visit (ie, 46 days after last dose of study medication)|Intent-to-treat (ITT): Participants who received at least one dose of study medication and in whom the primary efficacy parameter could be assessed at least once under study medication.||Months||95% Confidence Interval|Median
782371|NCT00813319|Primary|Total Doses Received of HPV Vaccine|As an additional primary outcome, we assessed the total number of vaccine doses received|measured at 7-months post randomization|||Doses|||Number
782372|NCT00813319|Secondary|STD Incidence|Number of participants who tested positive for any STD 7 months post randomization, information was gathered via medical chart abstraction|7 months post randomization|||participants|||Number
782373|NCT00813319|Primary|GARDASIL Vaccination Uptake and Compliance With Second and Third Doses|Number of participants who received at least 1 dose, 2 doses, 3 doses|measured at 7 months post-randomization|||participants|||Number
782374|NCT00813488|Secondary|Clinician Global Impression of Change (CGIC)Endpoint|"The CGIC is a standardized tool that measures the change in a patient's overall status rating since the start of the open-label extension period, in the opinion of the clinician.
The 7-point scale includes very much worse=-3, much worse=-2, minimally worse=-1,no change=0, minimally improved=+1, much improved=+2, and very much improved=+3. The CGIC was completed by the clinicians at visits 7, 8, and 9 (or early termination)."|End of open-label extension period|Open-Label Efficacy Assessment Set includes all subjects who were randomly assigned to the open-label treatments in the extension period and had an efficacy assessment for at least one of the efficacy questionnaires.||Units on a scale||Standard Deviation|Mean
782375|NCT00813488|Secondary|Clinician Global Impression of Change (CGIC) at Visit 9- 3 Months After Open Label Treatment|"The CGIC is a standardized tool that measures the change in a patient's overall status rating since the start of the open-label extension period, in the opinion of the clinician.
The 7-point scale includes very much worse=-3, much worse=-2, minimally worse=-1,no change=0, minimally improved=+1, much improved=+2, and very much improved=+3. The CGIC was completed by the clinicians at visits 7, 8, and 9 (or early termination), which correspond to 1, 2, or 3 months after the start of the open-label extension period."|3 months after start of open-label extension period|Open-Label Efficacy Assessment Set includes all subjects who were randomly assigned to the open-label treatments in the extension period and had an efficacy assessment for at least one of the efficacy questionnaires.||Units on a scale||Standard Deviation|Mean
782376|NCT00813488|Secondary|Clinician Global Impression of Change (CGIC) at Visit 8- 2 Months After Open Label Treatment|"The CGIC is a standardized tool that measures the change in a patient's overall status rating since the start of the open-label extension period, in the opinion of the clinician.
The 7-point scale includes very much worse=-3, much worse=-2, minimally worse=-1,no change=0, minimally improved=+1, much improved=+2, and very much improved=+3. Here it was assessed 2 months after the start of the open-label extension period.
The CGIC was completed by the clinicians at visits 7, 8, and 9 (or early termination)."|Two months after start of open-label extension period|Open-Label Efficacy Assessment Set includes all subjects who were randomly assigned to the open-label treatments in the extension period and had an efficacy assessment for at least one of the efficacy questionnaires.||Units on a scale||Standard Deviation|Mean
782377|NCT00813488|Secondary|Clinician Global Impression of Change at Visit 7- 1 Month After Open Label Treatment|"The CGIC is a standardized tool that measures the change in a patient’s overall status rating since the start of the open-label extension period, in the opinion of the clinician.
The 7-point scale includes very much worse=–3, much worse=–2, minimally worse=–1,no change=0, minimally improved=+1, much improved=+2, and very much improved=+3. The CGIC was completed by the clinicians at visits 7, 8, and 9 (or early termination) which correspond to 1, 2, or 3 months after the start of the open-label extension period."|One month after start of open-label extension|Open-Label Efficacy Assessment Set includes all subjects who were randomly assigned to the open-label treatments in the extension period and had an efficacy assessment for at least one of the efficacy questionnaires.||Unit on a scale||Standard Deviation|Mean
782947|NCT00815659|Secondary|Basal Interleukin 8 (IL-8) Level|IL-8 levels before (Visit 2-enrollment)|Baseline|Baseline IL-8 levels of participants||pg/mL||Standard Deviation|Mean
782378|NCT00813488|Secondary|Patient Global Impression of Change (PGIC) Endpoint|The PGIC is a standardized self-report tool that measures the change in a patient's overall status rating since the start of the open-label extension period. The 7-point scale includes very much worse= -3, much worse= -2, minimally worse= -1, no change=0, minimally improved= +1, much improved= +2, and very much improved= +3. Here it was assessed at the conclusion of the open-label extension period.|At conclusion of open-label extension period|Open-Label Efficacy Assessment Set includes all subjects who were randomly assigned to the open-label treatments in the extension period and had an efficacy assessment for at least one of the efficacy questionnaires.||Units on a scale||Standard Deviation|Mean
782379|NCT00813488|Secondary|Patient Global Impression of Change (PGIC) at Visit 9- 3 Months After Open Label Treatment|The PGIC is a standardized self-report tool that measures the change in a patient's overall status rating since the start of the open-label extension period. The 7-point scale includes very much worse= -3, much worse= -2, minimally worse= -1, no change=0, minimally improved= +1, much improved= +2, and very much improved= +3. Here it was assessed 3 months after the start of the open-label extension period.|3 months after start of open-label extension period|Open-Label Efficacy Assessment Set includes all subjects who were randomly assigned to the open-label treatments in the extension period and had an efficacy assessment for at least one of the efficacy questionnaires.||Units on scale||Standard Deviation|Mean
782380|NCT00813488|Secondary|Patient Global Impression of Change (PGIC) at Visit 8- 2 Months After Open Label Treatment|The PGIC is a standardized self-report tool that measures the change in a patient's overall status rating since the start of the open-label extension period. The 7-point scale includes very much worse= -3, much worse= -2, minimally worse= -1, no change=0, minimally improved= +1, much improved= +2, and very much improved= +3. Here it was assessed 2 months after the start of the open-label extension period.|2 months after start of open-label extension period|Open-Label Efficacy Assessment Set includes all subjects who were randomly assigned to the open-label treatments in the extension period and had an efficacy assessment for at least one of the efficacy questionnaires.||Units on scale||Standard Deviation|Mean
782381|NCT00813488|Secondary|Patient Global Impression of Change (PGIC) at Visit 7- 1 Month After Open Label Treatment|The PGIC is a standardized self-report tool that measures the change in a patient’s overall status rating since the start of the open-label extension period. The 7-point scale includes very much worse= –3, much worse= –2, minimally worse= –1, no change=0, minimally improved= +1, much improved= +2, and very much improved= +3. This was assessed 1 month after start of the open-label extension period.|One month after start of open-label treatment|Open-Label Efficacy Assessment Set includes all subjects who were randomly assigned to the open-label treatments in the extension period and had an efficacy assessment for at least one of the efficacy questionnaires.||Unit on a scale||Standard Deviation|Mean
782382|NCT00813488|Secondary|Breakthrough Pain Preference Questionnaire|The BTP preference questionnaire is a questionnaire used to measure patients’ preference for FBT or immediate-release oxycodone for management of BTP. The question is used to determine a patient’s preference between the study drugs given in the 2 double-blind treatment periods. The patient was asked to select 1 of the following: 1, a preference for study drug used in the 1st double-blind treatment period; 2, a preference for study drug used in the 2nd double-blind treatment period; or 3, no preference.|At Visit 6 ( up to 42 days depending upon how long it takes the patient to manage their BTP) after completion of both double-blind treatment periods.|Double-blind safety analysis set: 143 subjects who received both study drugs in this crossover study completed the Breakthrough Pain Preference Questionnaire after completing treatment||Participants|||Number
782383|NCT00813488|Secondary|Medication Performance Assessment 60 Minutes Post-treatment|The medication performance assessment assessed study drug performance on a 5-point categorical scale of 0-4 (0=poor, 1=fair,2=good, 3=very good, 4=excellent) 60 minutes after administration of study drug during the double-blind treatment periods and for the first 5 BTP episodes after each visit during the open-label extension period were recorded in the patient’s paper diary. Patients were asked “How well did your study medication perform in controlling this breakthrough pain episode?” The number of episodes rated for each category were recorded.|60 minutes post-treatment|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.||Episodes|Participants||Number
782384|NCT00813488|Secondary|Medication Performance Assessment 30 Minutes Post-treatment|The medication performance assessment assessed study drug performance on a 5-point categorical scale of 0-4 (0=poor, 1=fair,2=good, 3=very good, 4=excellent) 30 minutes after administration of study drug during the double-blind treatment periods and for the first 5 BTP episodes after each visit during the open-label extension period were recorded in the patient’s paper diary. Patients were asked “How well did your study medication perform in controlling this breakthrough pain episode?” The number of episodes rated for each category were recorded.|30 minutes post-treatment|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.||Episodes|Participants||Number
782385|NCT00813488|Secondary|Use of Standard Rescue Medication|Any use of standard rescue medication after the administration of study drug for relief of Breakthrough Pain (BTP) during the double-blind treatment phase was recorded in the patient’s diary. The number of breakthrough pain episodes for which study drug treatment was administered and which required rescue medication use was recorded.|Throughout the double-blind treatment period|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.||Episodes|Participants||Number
782461|NCT00813748|Primary|Treatment Received Following Adjudicated Anaphylactic Event – Case Participants|Treatment received following adjudicated anaphylactic event was classified as: antihistamine, epinephrine, inhaled beta agonists, systemic corticosteroids, and other. Number of participants in each treatment category is reported. Participants could have received more than 1 treatment.|Baseline (Enrollment Visit)|All enrolled participants.||participants|||Number
782386|NCT00813488|Secondary|Time to Meaningful Pain Relief (MPR) by Treatment <=60 Minutes|Time to MPR(subjective perception of meaningful reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes which time to MPR fell in that category was compared. Number of episodes in which MPR was achieved in 60 minutes or less was compared.|Time of study drug administration until 60 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.||Episodes|Participants||Number
782387|NCT00813488|Secondary|Time to Meaningful Pain Relief (MPR) by Treatment <=45 Minutes|Time to MPR(subjective perception of meaningful reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes which time to MPR fell in that category was compared. Number of episodes in which MPR was achieved in 45 minutes or less was compared.|From study drug administration until 45 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.||Episodes|Participants||Number
782388|NCT00813488|Secondary|Time to Meaningful Pain Relief (MPR) by Treatment <=30 Minutes|Time to MPR(subjective perception of meaningful reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes which time to MPR fell in that category was compared. Number of episodes in which MPR was achieved in 30 minutes or less was compared.|Time of study drug administration until 30 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.||Episodes|Participants||Number
782389|NCT00813488|Secondary|Time to Meaningful Pain Relief (MPR) by Treatment <=15 Minutes|Time to MPR(subjective perception of meaningful reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes which time to MPR fell in that category was compared. Number of episodes in which MPR was achieved in 15 minutes or less was compared.|Time of study drug administration until 15 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.||Episodes|Participants||Number
782390|NCT00813488|Secondary|Time to Meaningful Pain Relief (MPR) by Treatment <=10 Minutes|Time to MPR(subjective perception of meaningful reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes which time to MPR fell in that category was compared. Number of episodes in which MPR was achieved in 10 minutes or less was compared.|Time of study drug treatment until 10 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.||Episodes|Participants||Number
782391|NCT00813488|Secondary|Time to Meaningful Pain Relief (MPR) by Treatment - <= 5 Minutes|Time to MPR (subjective perception of meaningful reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point up to 60 minutes during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes which time to MPR fell in that category was compared.|From time study drug was taken until 5 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.||Episodes|Participants||Number
782392|NCT00813488|Secondary|Time to Any Pain Relief (APR) by Treatment <=60 Minutes|Time to APR (subjective perception of any reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point up to 60 minutes during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes which time to APR fell in that category was compared. Number of episodes where APR was achieved in 60 minutes or less was compared.|Time of study drug treatment until 60 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.||Episodes|Participants||Number
782462|NCT00813748|Primary|Total Omalizumab Doses Received When Adjudicated Anaphylactic Event Occurred – Case Participants|Omalizumab doses were classified as: 1 dose, 2 doses, 3 doses, 4-20 doses, 21-40 doses, 41-60 doses, >60 doses, and missing. Number of participants in each dose category is reported.|Baseline (Enrollment Visit)|All enrolled participants.||participants|||Number
782393|NCT00813488|Secondary|Time to Any Pain Relief (APR) by Treatment <=45 Minutes|Time to APR (subjective perception of any reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point up to 60 minutes during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes which time to APR fell in that category was compared. Number of episodes where APR was achieved in 45 minutes or less was compared.|Time of study drug treatment until 45 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.||Episodes|Participants||Number
782394|NCT00813488|Secondary|Time to Any Pain Relief (APR) by Treatment <=30 Minutes|Time to APR (subjective perception of any reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point up to 60 minutes during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes which time to APR fell in that category was compared. Number of episodes where APR was achieved in 30 minutes or less was compared.|Time of study drug administration till 30 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.||Episodes|Participants||Number
782395|NCT00813488|Secondary|Time to Any Pain Relief (APR) by Treatment <=15 Minutes|Time to APR (subjective perception of any reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point up to 60 minutes during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes which time to APR fell in that category was compared. Number of episodes where APR was achieved in 15 minutes or less was compared.|From study drug administration to 15 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.||Episodes|Participants||Number
782396|NCT00813488|Secondary|Time to Any Pain Relief (APR) by Treatment <=10 Minutes|Time to APR (subjective perception of any reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point up to 60 minutes during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes which time to APR fell in that category was compared. Number of episodes where APR was achieved in 10 minutes or less was compared.|From study drug treatment until 10 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.||Episodes|Participants||Number
782397|NCT00813488|Secondary|Time to Any Pain Relief (APR) by Treatment - <= 5 Minutes|Time to APR (subjective perception of any reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point up to 60 minutes during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes which time to APR fell in that category was compared. Number of episodes where APR was achieved in 5 minutes or less was compared.|From time study drug was taken until 5 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.||Episodes|Participants||Number
782398|NCT00813488|Secondary|Percent Total Pain Relief at 60 Minutes Posttreatment (%TOTPAR)|The PR score at set intervals after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete). The maximum TOTPAR score that could be achieved at 60 minutes is equal to 16; thus, %TOTPAR at 60 minutes is (TOTPAR60 /16) x 100.The % TOTPAR achieved 60 minutes after the administration of study drug was calculated during the double-blind treatment phase.|From 5 minutes through 60 minutes after study drug treatment|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.||Percentage change||Standard Deviation|Mean
782399|NCT00813488|Secondary|Total Pain Relief at 60 Minutes (TOTPAR60)|"The mean TOTPAR at 60 minutes will be calculated for each episode as the weighted sum of Pain Relief (PR) scores (5-point Likert scale, 0 = none to 4 = complete) at each assessment of PR (during the double-blind treatment period) until 60 minutes after study drug administration, as follows:
TOTPAR60 =(⅓ x PR5)+ (⅓ x PR10) +(⅓ x PR15)+ PR30 + PR45 + PR60. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry."|From 5 minutes to 60 minutes after dosing|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.||units on a scale|Participants|Standard Error|Least Squares Mean
782948|NCT00815659|Secondary|Interleukin 6 (IL-6) Level After 3 Months of Rosuvastatin Treatment|IL-6 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF (Last Observation Carried Forward) IL-6 levels of participants||pg/mL||Standard Deviation|Mean
782400|NCT00813488|Secondary|Pain Relief Score at 60 Minutes Post-treatment|The PR score 60 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete).|60 minutes after treatment with study drug|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.||Units on a scale||Standard Deviation|Mean
782401|NCT00813488|Secondary|Pain Relief Score at 45 Minutes Post-treatment|The PR score 45 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete).|45 minutes after treatment with study drug|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.||Units on a scale||Standard Deviation|Mean
782402|NCT00813488|Secondary|Pain Relief Score at 30 Minutes Post-treatment|The PR score 30 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete).|30 minutes after treatment with study drug|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.||Units on a scale||Standard Deviation|Mean
782403|NCT00813488|Secondary|Pain Relief Score at 15 Minutes Post-treatment|The PR score 15 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete).|15 minutes after treatment with study drug|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.||Units on a scale||Standard Deviation|Mean
782404|NCT00813488|Secondary|Pain Relief Score at 10 Minutes Post-treatment|The PR score 10 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete).|10 minutes after treatment with study drug|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.||Units on a scale||Standard Deviation|Mean
782405|NCT00813488|Secondary|Pain Relief (PR) Score at 5 Minutes Post-treatment|The PR score 5 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient’s diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete).|5 minutes after treatment|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.||Units on a scale||Standard Deviation|Mean
782406|NCT00813488|Secondary|Sum of Pain Intensity Difference at 60 Minutes Post-treatment (SPID60)|"PI scores were assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine during the double-blind treatment period. The SPID60 was derived from PID values. The SPID60 scores during the double-blind treatment phase were calculated as the time- weighted sum of the PID scores from 5 through 60 minutes,after the administration of the study drug.
SPID60 = SPID30 + PID45 + PID60. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry."|From 5 minutes after dosing through 60 minutes after dosing|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.||Units on a scale|Participants|Standard Error|Least Squares Mean
782407|NCT00813488|Secondary|Sum of Pain Intensity Difference at 30 Minutes Post-treatment (SPID30)|PI scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine. SPID30 were derived from PID values. The SPID30 scores during the double-blind treatment phase were calculated as the time- weighted sum of the PID scores from 5 through 30 minutes,after the administration of study drug. SPID30 = (⅓ x PID5) + (⅓ x PID10) + (⅓ x PID15) + PID30. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.|From 5 minutes after dosing through 30 minutes after dosing|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.||Units on a scale|Participants|Standard Error|Least Squares Mean
782427|NCT00813709|Secondary|Numbers of Participants With Binding Antibodies (BAb) and Neutralizing Antibody (NAb) at Month 60|BAbs are all antibodies which are capable of binding to the RNF irrespective of their binding site. NAbs are defined as a subgroup of BAbs which bind to the active sites of the RNF and therefore neutralize its potency. NAbs were detected using a viral cytopathic assay. BAbs were measured by using an ELISA.|Month 60|Data has been presented as per planned analysis for integrated DB population which included all participants who received at least one dose of DB treatment in REFLEX study 27025 (NCT00404352). 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure at this time point.||participants|||Number
782408|NCT00813488|Secondary|Percentage Change in Pain Intensity Difference (% PID) at 60 Minutes Post-treatment|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID60 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 60 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score.|Immediately pre-dose and 60 minutes after dosing|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.||Percentage change||Standard Deviation|Mean
782409|NCT00813488|Secondary|Percentage Change in Pain Intensity Difference (% PID) at 45 Minutes Post-treatment|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID45 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 45 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score.|Immediately pre-dose and 45 minutes after dosing|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.||Percentage change||Standard Deviation|Mean
782410|NCT00813488|Secondary|Percentage Change in Pain Intensity Difference (% PID) at 30 Minutes Post-treatment|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID30 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 30 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score.|Pre-dose and 30 minutes after dosing|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.||Percentage change||Standard Deviation|Mean
782411|NCT00813488|Secondary|Percentage Change in Pain Intensity Difference (% PID) at 15 Minutes Post-treatment|Pain intensity (PI) scores were assessed during the double-blind treatment period on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain. The PID15 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 15 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score.|Baseline (immediately pre-dose) and 15 minutes after dosing|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.||Percentage change||Standard Deviation|Mean
782412|NCT00813488|Secondary|Percentage Change in Pain Intensity Difference (% PID) at 10 Minutes Post-treatment|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain. The PID10 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 10 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score. This was assessed during the double-blind treatment period.|Immediately before treatment and 10 minutes after treatment.|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.||Percentage change||Standard Deviation|Mean
782413|NCT00813488|Secondary|Percentage Change in Pain Intensity Difference (% PID) at 5 Minutes Post-treatment|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID5 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 5 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score.|Immediately pre-dose and 5 minutes after dosing|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.||Percentage change||Standard Deviation|Mean
782414|NCT00813488|Secondary|Pain Intensity Difference (PID) at 60 Minutes Post-treatment|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID60 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 60 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.|Immediately pre-dose and 60 minutes after dosing|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.||Units on a scale|Participants|Standard Error|Least Squares Mean
782479|NCT00813761|Primary|Frequency of Daily Lens Dryness|Subjective measure of typical daily contact lens dryness reported at month 6 visit using a scale of 0 to 3. 0=Never, 1=Infrequently, 2=Frequently, 3=Constantly.|24 weeks|Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.||units on a scale||Standard Error|Least Squares Mean
782415|NCT00813488|Secondary|Pain Intensity Difference (PID) at 45 Minutes Post-treatment|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID45 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 45 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.|Immediately pre-dose and 45 minutes after dosing|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.||Units on a scale|Participants|Standard Error|Least Squares Mean
782416|NCT00813488|Secondary|Pain Intensity Difference (PID) at 30 Minutes Post-treatment|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID30 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 30 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.|Immediately pre-dose and 30 minutes after dosing|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.||Units on a scale|Participants|Standard Error|Least Squares Mean
782417|NCT00813488|Secondary|Pain Intensity Difference (PID) at 10 Minutes Post-treatment|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID10 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 10 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.|Immediately pre-dose and 10 minutes after dosing|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.||Units on a scale|Participants|Standard Error|Least Squares Mean
782418|NCT00813488|Secondary|Pain Intensity Difference (PID) at 5 Minutes Post-treatment|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID5 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 5 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.|Immediately pre-dose and 5 minutes after dosing|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.||Units on a scale|Participants|Standard Error|Least Squares Mean
782419|NCT00813488|Primary|Pain Intensity Difference (PID) at 15 Minutes Post-treatment (PID15)|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID15 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 15 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.|Immediately pre-dose and 15 minutes after dosing|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.||Units on scale|Participants|Standard Error|Least Squares Mean
782420|NCT00813592|Secondary|To Characterize the Safety and Tolerability of SOM230|Number of participants to experience adverse events|Monthly from study entry until subject taken off study, average 28 months|||participants|||Number
782421|NCT00813592|Secondary|To Determine the Clinical Benefit Rate (CR + PR + Stable Disease) of SOM230||November 2011||||||
782422|NCT00813592|Secondary|To Establish the Median PFS and Overall Survival (OS)||November 2011||||||
782423|NCT00813592|Secondary|To Establish the 6-month Progression-free Survival Rate||November 2011||||||
782424|NCT00813592|Secondary|To Determine the Duration of Response to SOM230||November 2011||||||
782425|NCT00813592|Primary|Objective Response Rate (ORR) of SOM230 Monotherapy in Meningioma|Measured the percentage of participants achieving a complete response or partial response as opposed to those participants with progressive disease or stable disease.|November 2011||||||
782426|NCT00813709|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Treatment Discontinuation|An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered. SAE: Any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition.|Month 24 up to Month 60|DB Safety Population 28981 (REFLEXION) included all the participants who discontinued DB treatment in REFLEX study 27025 (NCT00404352) and were enrolled in 28981 (REFLEXION) study and received at least one dose of DB treatment in this study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||participants|||Number
782428|NCT00813709|Secondary|Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Score at Month 60|The MSFC is a multidimensional clinical outcome measure which consists of three sub-tests; Timed 25-Foot Walk, 9-Hole Peg Test and Paced Auditory Serial Addition Test-3(PASAT-3). The Timed 25-Foot Walk is a quantitative measure of lower extremity function. The 9-Hole Peg Test is a quantitative measure of upper extremity (arm and hand) function. The PASAT is a measure of cognitive function that specifically assesses auditory information processing speed and flexibility, as well as calculation ability. Standardized results (Z-scores) of these sub-tests and the overall MSFC Z-score as an average of these three Z-scores was calculated. Higher Z-scores reflect better neurological function and a positive change from baseline indicates improvement. An increase in score indicates an improvement (range -3 to +3).|Baseline (Day 1 of Study 27025), Month 60|"Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352). n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."||Z-score||Standard Deviation|Mean
782429|NCT00813709|Secondary|Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Month 60|EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. The change in EDSS score at Month 60 was calculated as EDSS score at Month 60 minus EDSS score at baseline.|Baseline (Day 1 of Study 27025), Month 60|"Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352). n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."||units on a scale||Standard Deviation|Mean
782430|NCT00813709|Secondary|Percentage of Relapse-Free Participants at Month 60|A relapse was defined as the development of new or the exacerbation of existing neurological symptoms or signs, in the absence of fever, lasting for 24 hours and with a previous period for more than 30 days with a stable or an improving condition.|Month 60|Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352).||percentage of participants|||Number
782431|NCT00813709|Secondary|Change From Baseline in Paced Auditory Serial Addition Test 3 (PASAT-3) Score at Month 60|The PASAT is a measure of cognitive function that specifically assesses auditory information processing speed and flexibility, as well as calculation ability. Score ranges from ‘0-60’. Higher scores reflect better neurological function and a positive change from baseline indicates improvement.|Baseline (Day 1 of Study 27025), Month 60|"Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352). n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."||units on a scale||Standard Deviation|Mean
782432|NCT00813709|Secondary|Percentage of Participants With Conversion to McDonald Multiple Sclerosis (MS) at Month 60|The McDonald criteria use dissemination in time and space established by MRI findings to provide a clinical diagnosis for MS. Dissemination in time is established by a new T2 or Gd+ lesion found on a repeat MRI. Dissemination in space is established by the presence of any 3 of the following: 1 Gd+ lesion or 9 T2 bright lesions if there is no enhancement; greater than or equal to 1 infratentorial lesion; greater than or equal to 1 juxtacortical lesion; greater than or equal to 3 periventricular lesions.|Month 60|Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352).||percentage of participants|||Number
782433|NCT00813709|Secondary|Percent Change From Baseline in Brain Volume at Month 60|Percent Change in brain volume was measured by using MRI scans.|Baseline (Day 1 of Study 27025), Month 60|Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352). 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure at this time point.||percent change||Standard Deviation|Mean
782434|NCT00813709|Secondary|Change From Baseline in Time Constant 1 (T1) Hypointense Volume, and Time Constant 2 (T2) Lesion Volume at Month 60|Change from baseline in lesion volume was measured by using MRI scans for T1 hypointense lesions and T2 lesions.|Baseline (Day 1 of Study 27025), Month 60|"Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352). n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."||mm^3||Standard Deviation|Mean
782435|NCT00813709|Secondary|Number of Combined Unique Active (CUA) Lesions, New Time Constant 2 (T2) Lesions, New Gadolinium Enhanced (Gd+) Lesions and New T1 Lesions Per Participant Per Scan at Month 60|Number of CUA lesions, new T2 lesions, new Gd+ Lesions and new T1 lesions were measured by using MRI scans.|Month 60|"Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352). n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."||lesions||Standard Deviation|Mean
782436|NCT00813709|Secondary|Time to Confirmed Expanded Disability Status Scale (EDSS) Progression up to 60 Months|EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. A confirmed EDSS progression was defined EDSS greater than or equal to 1.0 point confirmed during a visit performed 6 months later. Time to confirmed EDSS progression was represented by Kaplan-Meier estimates of the cumulative percentage (%) of participants with confirmed EDSS progression.|Baseline (Day 1 of Study 27025) up to 60 Months|Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352).||% of participants with EDSS progression|||Number
782445|NCT00813709|Secondary|Percent Change From Baseline in Brain Volume at Month 36|Percent change in brain volume was measured by using MRI scans.|Baseline (Day 1 of Study 27025), Month 36|Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352). 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure at this time point.||percent change||Standard Deviation|Mean
782480|NCT00813761|Primary|Frequency of Eye Discomfort|Subjective measure of typical daily eye discomfort reported at month 6 visit using a scale of 0 to 3. 0=Never, 1=Infrequently, 2=Frequently, 3=Constantly.|24 weeks|Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.||units on a scale||Standard Error|Least Squares Mean
782437|NCT00813709|Secondary|Time to Conversion to Clinically Definite Multiple Sclerosis (CDMS) Defined by Either a Second Attack or a Sustained Increase (Greater Than or Equal to 1.5 Points) in the Expanded Disability Status Scale (EDSS) Score up to Month 60|CDMS was defined by the occurrence of a second attack or relapse over 60 months in participants who presented with clinically isolated syndrome (CIS) accompanied by an abnormal magnetic resonance imaging (MRI) scan. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to multiple sclerosis [MS]) was calculated. Time to conversion to CDMS was represented by Kaplan-Meier estimates of the cumulative percentage (%) of participants with CDMS.|Baseline (Day 1 of Study 27025) up to 60 Months|Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352).||Cumulative % of participants with CDMS||95% Confidence Interval|Number
782438|NCT00813709|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Treatment Discontinuation|An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered. SAE: Any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition.|Month 24 up to Month 36 (DB treatment period for study 28981 (REFLEXION)|DB Safety Population 28981 (REFLEXION) included all the participants who discontinued DB treatment in REFLEX study 27025 (NCT00404352) and were enrolled in 28981 (REFLEXION) study and received at least one dose of DB treatment in this study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||participants|||Number
782439|NCT00813709|Secondary|Numbers of Participants With Binding Antibodies (BAb) and Neutralizing Antibody (NAb) at Month 36|BAbs are all antibodies which are capable of binding to the investigational drug molecule (RNF) irrespective of their binding site. NAbs are defined as a subgroup of BAbs which bind to the active sites of the RNF and therefore neutralize its potency. NAbs were detected using a viral cytopathic assay. BAbs were measured by using an ELISA (Enzyme-linked immunosorbent assay).|Month 36|Data has been presented as per planned analysis for integrated DB population which included all participants who received at least one dose of DB treatment in REFLEX study 27025 (NCT00404352). 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure at this time point.||participants|||Number
782440|NCT00813709|Secondary|Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Score at Month 36|The MSFC is a multidimensional clinical outcome measure which consists of three sub-tests; Timed 25-Foot Walk, 9-Hole Peg Test and Paced Auditory Serial Addition Test-3(PASAT-3). The Timed 25-Foot Walk is a quantitative measure of lower extremity function. The 9-Hole Peg Test is a quantitative measure of upper extremity (arm and hand) function. The PASAT is a measure of cognitive function that specifically assesses auditory information processing speed and flexibility, as well as calculation ability. Standardized results (Z-scores) of these sub-tests and the overall MSFC Z-score as an average of these three Z-scores was calculated. Higher Z-scores reflect better neurological function and a positive change from baseline indicates improvement. An increase in score indicates an improvement (range -3 to +3).|Baseline (Day 1 of Study 27025), Month 36|"Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352). n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."||Z-score||Standard Deviation|Mean
782441|NCT00813709|Secondary|Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Month 36|EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. The change in EDSS score at Month 36 was calculated as EDSS score at Month 36 minus EDSS score at baseline.|Baseline (Day of Study 27025), Month 36|"Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352). n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."||units on a scale||Standard Deviation|Mean
782442|NCT00813709|Secondary|Percentage of Relapse-Free Participants at Month 36|A relapse was defined as the development of new or the exacerbation of existing neurological symptoms or signs, in the absence of fever, lasting for 24 hours and with a previous period for more than 30 days with a stable or an improving condition.|Month 36|Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352).||Percentage of participants|||Number
782443|NCT00813709|Secondary|Change From Baseline in Paced Auditory Serial Addition Test 3 (PASAT-3) Score at Month 36|The Paced Auditory Serial Addition Test (PASAT) is a measure of cognitive function that specifically assesses auditory information processing speed and flexibility, as well as calculation ability. Score ranges from ‘0-60’. Higher scores reflect better neurological function and a positive change from baseline indicates improvement.|Baseline (Day of Study 27025), Month 36|"Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352). n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."||units on a scale||Standard Deviation|Mean
782444|NCT00813709|Secondary|Percentage of Participants With Conversion to McDonald Multiple Sclerosis (MS) up to 36 Months|The McDonald criteria use dissemination in time and space established by MRI findings to provide a clinical diagnosis for MS. Dissemination in time is established by a new T2 or Gd+ lesion found on a repeat MRI. Dissemination in space is established by the presence of any 3 of the following: 1 Gd+ lesion or 9 T2 bright lesions if there is no enhancement; greater than or equal to 1 infratentorial lesion; greater than or equal to 1 juxtacortical lesion; greater than or equal to 3 periventricular lesions.|Baseline (Day 1 of Study 27025) up to CDMS conversion and/or up to 36 Months|Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352).||percentage of participants|||Number
782481|NCT00813761|Primary|Lens Comfort|Lens comfort at time of month 6 visit, using a scale of 0 to 10, where 10=excellent.|24 weeks|Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.||units on a scale||Standard Error|Least Squares Mean
782446|NCT00813709|Secondary|Change From Baseline in Time Constant 1 (T1) Hypointense Lesion Volume and Time Constant 2 (T2) Lesion Volume at Month 36|Change from baseline in lesion volume was measured by using MRI scans for T1 hypointense lesions and T2 lesions at Month 36|Baseline (Day 1 of Study 27025), Month 36|"Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352). n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."||cubic millimeter (mm^3)||Standard Deviation|Mean
782447|NCT00813709|Secondary|Number of Combined Unique Active (CUA) Lesions, New Time Constant 2 (T2) Lesions, New Gadolinium Enhanced (Gd+) Lesions and New Time Constant 1 (T1) Lesions Per Participant Per Scan at Month 36|Number of CUA lesions, new T2 lesions, new Gd+ lesions and new T1 lesions were measured by using MRI scans.|Month 36|Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352). 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure at this time point.||lesions||Standard Deviation|Mean
782448|NCT00813709|Secondary|Time to Confirmed Expanded Disability Status Scale (EDSS) Progression up to 36 Months|EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. A confirmed EDSS progression was defined EDSS greater than or equal to 1.0 point confirmed during a visit performed 6 months later. Time to confirmed EDSS progression was represented by Kaplan-Meier estimates of the cumulative percentage (%) of participants with confirmed EDSS progression.|Baseline (Day 1 of Study 27025) up to 36 Months|Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352).||% of participants with EDSS progression|||Number
782449|NCT00813709|Primary|Time to Conversion to Clinically Definite Multiple Sclerosis (CDMS) Defined by Either a Second Attack or a Sustained Increase (Greater Than or Equal to 1.5 Points) in the Expanded Disability Status Scale (EDSS) Score up to 36 Months|CDMS was defined by the occurrence of a second attack or relapse over 36 months in participants who presented with clinically isolated syndrome (CIS) accompanied by an abnormal magnetic resonance imaging (MRI) scan. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to multiple sclerosis [MS]) was calculated. Time to conversion to CDMS was represented by Kaplan-Meier estimates of the cumulative percentage (%) of participants with CDMS.|Baseline (Day 1 of Study 27025) up to 36 Months|Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352).||Cumulative % of participants with CDMS||95% Confidence Interval|Number
782450|NCT00813748|Primary|Number of Participants With ATA – Skin Testing Substudy|Participants with positive IgG ATA, negative IgG ATA, positive IgE ATA, and negative IgE ATA are reported.|Substudy Week 10|Skin test substudy: all enrolled participants. Here, number of participants analyzed signifies participants with available data for this outcome.||participants|||Number
782451|NCT00813748|Primary|Number of Participants With Positive Skin Reaction After Skin Prick Test – Skin Testing Substudy||Substudy Day 1|Skin test substudy: all enrolled participants. One participant discontinued prematurely from the skin test substudy before providing data and was excluded.||participants|||Number
782452|NCT00813748|Primary|Number of Participants With Anti-Therapeutic Antibodies (ATA) - Main Study|Participants with positive immunoglobulin G (IgG) ATA, negative IgG ATA, positive immunoglobulin E (IgE) ATA, and negative IgE ATA are reported.|Baseline (Enrollment Visit)|All enrolled participants. Here, number of participants analyzed signifies participants with available data for this outcome.||participants|||Number
782453|NCT00813748|Primary|Medications Within Two Weeks Prior to Blood Draw|Number of participants in each medication class is reported. Participants could have received more than 1 medication class.|Baseline (Enrollment Visit)|All enrolled participants.||participants|||Number
782454|NCT00813748|Primary|Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event – Case Participants|Number of participants in each medication class is reported. Participants could have received more than 1 medication class. NEC: Not Elsewhere Classified.|Baseline (Enrollment Visit)|All enrolled participants.||participants|||Number
782455|NCT00813748|Primary|Treatment Following Subsequent Unadjudicated Anaphylactic Events – Case Participants|Treatment received following subsequent unadjudicated anaphylactic event was classified as: antihistamine, epinephrine, inhaled beta agonists, systemic corticosteroids, and other. Number of participants in each treatment category is reported. Participants could have received more than 1 treatment.|Baseline (Enrollment Visit)|All enrolled participants. Here, number of participants analyzed signifies participants with available data for this outcome.||participants|||Number
782456|NCT00813748|Primary|Number of Participants With Subsequent Unadjudicated Anaphylactic Events – Case Participants||Baseline (Enrollment Visit)|All enrolled participants.||participants|||Number
782457|NCT00813748|Primary|Treatment Following Prior Unadjudicated Anaphylactic Events – Case Participants|Treatment received following prior unadjudicated anaphylactic events was classified as: antihistamine, epinephrine, inhaled beta agonists, systemic corticosteroids, and other. Number of participants in each treatment category is reported. Participants could have received more than 1 treatment.|Baseline (Enrollment Visit)|All enrolled participants. Here, number of participants analyzed signifies participants with available data for this outcome.||participants|||Number
782458|NCT00813748|Primary|Number of Participants With Prior Unadjudicated Anaphylactic Events – Case Participants||Baseline (Enrollment Visit)|All enrolled participants.||participants|||Number
782459|NCT00813748|Primary|Number of Participants Reinitiating Omalizumab After Adjudicated Anaphylactic Event – Case Participants||Baseline (Enrollment Visit)|All enrolled participants.||participants|||Number
782460|NCT00813748|Primary|Outcome Attributed to Adjudicated Anaphylactic Event – Case Participants|Outcomes of adjudicated anaphylactic event were classified as: death, life-threatening, required in-patient hospitalization or its prolongation, disabling, congenital anomaly/birth defect in offspring of participant, and other (outcome did not meet any of the above criteria, but may jeopardize the participant, and may require medical or surgical intervention to prevent one of the outcomes listed above). Number of participants in each outcome category is reported. Only outcomes with results are reported.|Baseline (Enrollment Visit)|All enrolled participants.||participants|||Number
782949|NCT00815659|Secondary|Basal Interleukin 6 (IL-6) Level|IL-6 levels before (Visit 2-enrollment)|Baseline|Baseline IL-6 levels of participants||pg/mL||Standard Deviation|Mean
782463|NCT00813748|Primary|Categorical Time From Last Omalizumab Dose to Adjudicated Anaphylactic Symptoms – Case Participants|Time from last omalizumab dose to adjudicated anaphylactic symptoms was classified as: less than (<) 30 minutes, 30-60 minutes, greater than (>) 60-90 minutes, >90-120 minutes, >120 minutes to 360 minutes, and missing. Number of participants in each time category is reported.|Baseline (Enrollment Visit)|All enrolled participants.||participants|||Number
782464|NCT00813748|Primary|Time From Last Omalizumab Dose to Adjudicated Anaphylactic Symptoms – Case Participants||Baseline (Enrollment Visit)|All enrolled participants. Here, number of participants analyzed signifies participants with available data for this outcome.||minutes||Full Range|Median
782465|NCT00813748|Primary|Number of Participants With Clinical Signs and Symptoms of Adjudicated Anaphylaxis Events – Case Participants|Clinical signs and symptoms of adjudicated anaphylaxis events included: Cutaneous/Subcutaneous/Mucosal, Respiratory (R), Cardiovascular (CV), and Gastrointestinal (GIT) signs and symptoms.|Baseline (Enrollment Visit)|All enrolled participants.||participants|||Number
782466|NCT00813761|Secondary|Physiological Responses|"Mean of physiological outcomes for those subjects who are identified as susceptible versus non-susceptible for Solution Induced Corneal Staining (SICS). Physiological findings are done through a slit lamp examination and are known as biomicroscopy measurements. Measures are given in terms of average score with a minimum of zero and a worse grade the higher the value with a range of 0 to 4, (tarsal roughness is 0-7 scale)."|24 weeks|All subjects, enrolled, randomized, and completed the study. Subjects where identified as 'stainers' or 'non-stainers' and outcomes were reported by this stratification.||units on a scale||Standard Deviation|Least Squares Mean
782467|NCT00813761|Secondary|Wearing Time and Comfortable Wearing Time|"Mean of physiological outcomes for those subjects who are identified as susceptible versus non-susceptible for Solution Induced Corneal Staining (SICS). Average wearing time and average comfortable wearing time."|24 weeks|All subjects, enrolled, randomized, and completed the study. Subjects where identified as 'stainers' or 'non-stainers' and outcomes were reported per this stratification.||hours||Standard Deviation|Least Squares Mean
782468|NCT00813761|Secondary|Intensity of Physiological Outcomes|"Mean of physiological outcomes for those subjects who are identified as susceptible versus non-susceptible to Solution Induced Corneal Staining (SICS). These measures are related to intensity of outcomes, i.e. discomfort, burning, dryness, etc. with lower scores being better on a scale of 1-5."|24 weeks|All subjects, enrolled, randomized, and completed the study. Subjects where identified as 'stainers' or 'non-stainers' and outcomes were reported per this stratification.||units on a scale||Standard Deviation|Least Squares Mean
782469|NCT00813761|Primary|Tarsal Roughness|The roughness of the inner lining of the eyelids, measured on a 0 to 7 scale. 0=Smooth, 1=Slightly uneven, 2=Uneven surface, 3=Uneven surface with loss of transparency & superficial vessels, 4=Small papillae, poor transparency, 5=Papillae greater than 0.5mm in size, no transparency, 6=Papillae greater than 0.5mm in size, vessels inside papillae, 7=Large papillae|24 weeks|Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.||units on a scale|eyes|Standard Error|Least Squares Mean
782470|NCT00813761|Primary|Upper Tarsal Redness|Redness of the blood vessels in the inner lining of the upper eyelid, on a scale of 0 to 4. 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe|24 weeks|Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.||units on a scale|eyes|Standard Error|Least Squares Mean
782471|NCT00813761|Primary|Lower Tarsal Redness|Redness of the blood vessels in the inner lining of the lower eyelid, on a scale of 0 to 4. 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe|24 weeks|Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.||units on a scale|eyes|Standard Error|Least Squares Mean
782472|NCT00813761|Primary|Bulbar Redness|Redness of the blood vessels in the tissues overlaying the white of the eye, on a scale of 0 to 4. 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe|24 weeks|Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.||units on a scale|eyes|Standard Error|Least Squares Mean
782473|NCT00813761|Primary|Limbal Redness|Redness at the transition zone between the white of the eye and the clear window of the eye, the cornea, on a scale of 0 to 4. 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe|24 weeks|Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.||units on a scale|eyes|Standard Error|Least Squares Mean
782474|NCT00813761|Primary|Average Corneal Fluorescein Staining Area|corneal staining measured over 5 areas, averaged, and graded as a single score average on a scale of 0 to 10, 0=0%, 1=10%, 2=20%, 3=30%, 4=40%, 5=50%, 6=60%, 7=70%, 8=80%, 9=90%, 10=100%.|24 weeks|Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.||units on a scale|Eyes|Standard Error|Least Squares Mean
782475|NCT00813761|Primary|Average Corneal Fluorescein Type Staining|staining measured over five sectors of the cornea and classified as a type of staining on a scale of 0 to 4. 0=None, 1=Micropunctate, 2=Macropunctate, 3=Coalesced Macropunctate, 4=Patch.|24 weeks|Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.||units on a scale|Eyes|Standard Error|Least Squares Mean
782476|NCT00813761|Primary|Frequency of Tearing|Subjective measure of typical daily tearing related to lens wear reported at month 6 visit using a scale of 0 to 3. 0=Never, 1=Infrequently, 2=Frequently, 3=Constantly.|24 weeks|Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.||units on a scale||Standard Error|Least Squares Mean
782477|NCT00813761|Primary|Frequency of Itching|Subjective measure of typical daily eye burning and stinging reported at month 6 visit using a scale of 0 to 3. 0=Never, 1=Infrequently, 2=Frequently, 3=Constantly.|24 weeks|Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.||units on a scale||Standard Error|Least Squares Mean
782478|NCT00813761|Primary|Frequency of Eye Burning/Stinging|Subjective measure of typical daily eye burning and stinging reported at month 6 visit using a scale of 0 to 3. 0=Never, 1=Infrequently, 2=Frequently, 3=Constantly.|24 weeks|Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.||units on a scale||Standard Error|Least Squares Mean
782482|NCT00813761|Primary|Average Daily Comfortable Wear Time|Average hours per day that contact lens were worn comfortably.|24 weeks|Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.||Hours||Standard Error|Least Squares Mean
782484|NCT00805545|Primary|Endometritis and Wound Infection|In non-pregnant patients having certain types of surgery with a high risk of infection, prophylactic antibiotics are routinely administered before the surgical procedure begins to ensure that a high level of antibiotic is present in tissue prior to the time that maximum bacterial contamination occurs. However, there has been concern about exposing the fetus in utero to antibiotics. The question to be addressed was whether preoperative antibiotics (as opposed to antibiotics administered after clamping of the umbilical cord) benefitted the mother without increasing risk for the baby.|Patients were followed from the time of surgery until 6 weeks postpartum.|All 194 patients who received preoperative antibiotics and who completed the study were analyzed. All 197 patients who received post-cord clamping antibiotics and who completed the study were analyzed.||patients infected||95% Confidence Interval|Number
782485|NCT00805675|Secondary|Characterization of Very Early Viral Kinetics Through Half-live of Free Virus|"The underlying bi‐phasic model of viral kinetics can be described as follows:
V(t) (1 )pI(t) cV(t)I(t) (1 ) (T I(t))V(t) I(t)where V denotes serum viral load, I productively infected cells, ε the efficiency factor of blocking virus production, p the viral production rate, c the viral clearance rate, η the efficiency factor of blocking de novo infection, β the de novo infection rate, Tg comprise all infected and uninfected target cells, and δ the rate of infected cell loss"|Week 12|The Intent to Treat (ITT) data set consisted of the participants that had been randomized and had taken the investigational drug at least once.||Hours||Standard Deviation|Mean
782486|NCT00805675|Secondary|Characterization of Very Early Viral Kinetics Through Efficiency Factor of Blocking Virus Production.|"The underlying bi‐phasic model of viral kinetics can be described as follows:
V(t) (1 )pI(t) cV(t) I(t) (1 ) (T I(t))V(t) I(t) where V denotes serum viral load, I productively infected cells, ε the efficiency factor of blocking virus production, p the viral production rate, c the viral clearance rate, η the efficiency factor of blocking de novo infection, β the de novo infection rate, Tg comprise allinfected and uninfected target cells, and δ the rate of infected cell loss"|Week 12|The Intent to Treat (ITT) data set consisted of the participants that had been randomized and had taken the investigational drug at least once.||Percentage||Standard Deviation|Mean
782487|NCT00805675|Secondary|Characterization of Very Early Viral Kinetics Through Rate of Infected Cell Loss|"The underlying bi‐phasic model of viral kinetics can be described as follows:
V(t) (1 )pI(t) cV(t)I(t) (1 ) (T I(t))V(t) I(t)where V denotes serum viral load, I productively infected cells, ε the efficiency factor of blocking virus production, p the viral production rate, c the viral clearance rate, η the efficiency factor of blocking de novo infection, β the de novo infection rate, Tg comprise all infected and uninfected target cells, and δ the rate of infected cell loss"|Week 12|The Intent to Treat (ITT) data set consisted of the participants that had been randomized and had taken the investigational drug at least once.||day^-1||Standard Deviation|Mean
782488|NCT00805675|Secondary|Characterization of Very Early Viral Kinetics Through Viral Clearance|"The underlying bi‐phasic model of viral kinetics can be described as follows:
V(t) (1 )pI(t) cV(t)I(t) (1 ) (T I(t))V(t) I(t)where V denotes serum viral load, I productively infected cells, ε the efficiency factor of blocking virus production, p the viral production rate, c the viral clearance rate, η the efficiency factor of blocking de novo infection, β the de novo infection rate, Tg comprise all infected and uninfected target cells, and δ the rate of infected cell loss"|Week 12|The Intent to Treat (ITT) data set consisted of the participants that had been randomized and had taken the investigational drug at least once.||day^-1||Standard Deviation|Mean
782489|NCT00805675|Secondary|Characterization of Very Early Viral Kinetics Through Estimated Viral Load|"The underlying bi‐phasic model of viral kinetics can be described as follows:
V(t) (1 )pI(t) cV(t)I(t) (1 ) (T I(t))V(t) I(t)where V denotes serum viral load, I productively infected cells, ε the efficiency factor of blocking virus production, p the viral production rate, c the viral clearance rate, η the efficiency factor of blocking de novo infection, β the de novo infection rate, Tg comprise all infected and uninfected target cells, and δ the rate of infected cell loss"|Week 12|The Intent to Treat (ITT) data set consisted of the participants that had been randomized and had taken the investigational drug at least once.||log10 copies/ml||Standard Deviation|Mean
782490|NCT00805675|Secondary|"Percentage of Patients Who Achieve Hepatitis B e Antigen (HBeAg) Loss and HBeAg Seroconversion at Week 12"|"HBeAg loss is defined as the loss of detectable serum HBeAg in a patient who was HBeAg positive at baseline. HBeAg seroconversion is defined as HBeAg loss with detectable Hepatitis B 'e' antibody (HBeAb). HBeAg stands for hepatitis B e antigen. This antigen is a protein from the hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the person is infectious and is able to spread the virus to other people."|Week 12|The Intent to Treat (ITT) data set consisted of the participants that had been randomized and had taken the investigational drug at least once. Note: In this analysis 1 patient HBeAg loss in the Telbivudine 600 mg and Tenofovir 300 mg Treatment Group.||Percentage of Participants|||Number
782491|NCT00805675|Secondary|Percentage of Patients Who Are Polymerase Chain Reaction(PCR)Negative at Week 12|Polymerase Chain Reaction (PCR) Negative is defined as HBV DNA levels <25 copies/ml.|Week 12|The Intent to Treat (ITT) data set consisted of the participants that had been randomized and had taken the investigational drug at least once. (1 pat DNA<169 cps/ml)||Percentage of Participants|||Number
782492|NCT00805675|Secondary|Change in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Level From Baseline to Weeks 2, 4 and 8.|Baseline HBV DNA is defined as the last pre-dose assessment of HBV DNA. Serum HBV DNA determinations were performed at a central laboratory through use of the COBAS TaqMan™ HBV DNA assay (Roche Molecular Systems, Pleasanton, CA, USA) which utilized the Real-time polymerase chain reaction (PCR) method and automated extraction by Cobas Ampliprep (threshold for detection 12 IU/mL). The Screening serum HBV DNA values must be ≥ 7 log10 copies/mL by COBAS TaqMan™ HBV DNA assay.|Baseline, Week 2, Week 4, Week 8|The Intent to Treat (ITT) data set consisted of the participants that had been randomized and had taken the investigational drug at least once.||log10 copies/mL||Standard Deviation|Mean
782505|NCT00805766|Secondary|CDAI Change at Each Evaluation Time Point in the Increased Dose Period|To confirm the decrease in median CDAI at week 8 by ≥ 50 points compared to the CDAI score at week 0 in the increased dose period. In the indication of CDAI change, decrease in CDAI was expressed by positive numbers. CDAI is a research tool used to quantify the symptoms of patients with Crohn’s disease. CDAI scores generally range from 0 to 600 points. Clinical remission = CDAI < 150 points. Moderate disease = CDAI 220 - 450 points. Severe disease = CDAI > 450 points.|every 4 weeks for up to 40 weeks|||units on a scale||Full Range|Median
782493|NCT00805675|Primary|Change in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Level From Baseline to Week 12.|Baseline HBV DNA is defined as the last pre-dose assessment of HBV DNA. Serum HBV DNA determinations were performed at a central laboratory through use of the COBAS TaqMan™ HBV DNA assay (Roche Molecular Systems, Pleasanton, CA, USA) which utilized the Real-time polymerase chain reaction (PCR) method and automated extraction by Cobas Ampliprep (threshold for detection 12 IU/mL). The Screening serum HBV DNA values must be ≥ 7 log10 copies/mL by COBAS TaqMan™ HBV DNA assay.|Baseline, Week 12|The Intent to Treat (ITT) data set consisted of the participants that had been randomized and had taken the investigational drug at least once.||log10 copies/mL||Standard Deviation|Mean
782494|NCT00805740|Secondary|Time to Death|Time to death (days) was assessed as date of death minus first treatment date plus 1.|Baseline up to 6-week follow-up (6 weeks after EOT)|Safety analysis set included all randomized participants who received at least 1 dose of study drug.||days||Full Range|Median
782495|NCT00805740|Secondary|Percentage of Participants With All-cause Mortality|All-cause mortality during study therapy and at follow-up visits reported as unique death at EOT, 2 week follow-up and 6 week follow-up.|Baseline to EOT (Day 14 to 42), After EOT to 2-week follow-up (2 weeks after EOT), After 2-week follow-up to 6-week follow-up (6 weeks after EOT)|Safety analysis set included all randomized participants who received at least 1 dose of study drug.||percentage of participants|||Number
782496|NCT00805740|Secondary|Time to Negative Blood Culture|Negative blood culture referred to absence of Candida sp. in the blood sample of participants who had a positive blood culture at baseline. Time to negative blood culture (days) was calculated as date of first negative blood culture minus first treatment date plus 1.|Baseline up to 6-week follow-up (6 weeks after EOT)|A sub-set of MITT population included only those participants who had a positive blood culture for Candida species at baseline.||days||Full Range|Median
782497|NCT00805740|Secondary|Percentage of Participants With New Infection|New Infection: participant presenting with clinical failure with the emergence of new Candida sp. at the original site of infection or at a distant site of infection. Clinical failure: no significant improvement in signs and symptoms, or death due to Candida infection. Participants must have had received at least 3 doses of study drug to be classified as a failure.|2-week follow-up (2 weeks after EOT), 6-week follow-up (6 weeks after EOT)|MITT population included all participants who received at least 1 dose of study drug and had a positive culture for Candida species.||percentage of participants|||Number
782498|NCT00805740|Secondary|Percentage of Participants With Relapse|Relapse was defined as any baseline Candida sp. isolated following eradication (documented or presumed) or culture data not available for participants with a clinical response of failure after a previous response of success. Prophylactic treatment with oral antifungal agents was not sufficient to document a relapse.|2-week follow-up (2 weeks after EOT), 6-week follow-up (6 weeks after EOT)|MITT population included all participants who received at least 1 dose of study drug and had a positive culture for Candida species.||percentage of participants|||Number
782499|NCT00805740|Secondary|Percentage of Participants With Clinical Response|A participant had a successful clinical response if there was clinical response of cure or improvement. Clinical response of cure: resolution of signs and symptoms attributed to Candida infection; no additional systemic or oral antifungal treatment required to complete the course of therapy. Clinical response of improvement: significant, but incomplete resolution of signs and symptoms of Candida infection; no additional systemic or oral antifungal treatment required.|Day 10|MITT population included all participants who received at least 1 dose of study drug and had a positive culture for Candida species.||percentage of participants||95% Confidence Interval|Number
782500|NCT00805740|Secondary|Percentage of Participants With Response Based on Clinical Cure and Microbiological Success|A participant had a successful response if there was clinical response of cure and microbiological success (eradication or presumed eradication). Clinical response of cure: resolution of signs and symptoms attributed to Candida infection; no additional systemic or oral antifungal treatment required to complete the course of therapy. Microbiological eradication or presumed eradication: baseline pathogen not isolated from original site culture, or culture data not available for a participant with successful clinical outcome.|EOT (Day 14 to 42), 2-week follow-up (2 weeks after EOT), 6-week follow-up (6 weeks after EOT)|MITT population. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. Here, ‘n’ signifies those participants who were evaluable for this measure at given time points for each group respectively.||percentage of participants|||Number
782501|NCT00805740|Secondary|Percentage of Participants With Global Response at 2-week and 6-week Follow-up Visit|Participants had successful global response if there was clinical response of cure/improvement,microbiological eradication/presumed eradication.Clinical cure:resolution of signs/symptoms (s/s) of Candida infection;no additional systemic/oral antifungal treatment needed.Clinical improvement:significant,but incomplete resolution of s/s of Candida infection;no additional systemic/oral antifungal treatment needed.Microbiological eradication/presumed eradication:baseline pathogen not isolated from original site culture,or culture data not available for participant with successful clinical outcome.|2-week follow-up (2 weeks after end of treatment [EOT]), 6-week follow-up (6 weeks after EOT)|MITT population included all participants who received at least 1 dose of study drug and had a positive culture for Candida species. Only participants who completed therapy or who had global response of failure at EOT were evaluable for 2- and 6-week follow-up analysis.||percentage of participants||95% Confidence Interval|Number
782502|NCT00805740|Primary|Percentage of Participants With Global Response at End of Treatment (Day 14 To Day 42)|Participants had successful global response if there was clinical response of cure/improvement,microbiological eradication/presumed eradication.Clinical cure:resolution of signs/symptoms (s/s) of Candida infection;no additional systemic/oral antifungal treatment needed.Clinical improvement:significant,but incomplete resolution of s/s of Candida infection;no additional systemic/oral antifungal treatment needed.Microbiological eradication/presumed eradication:baseline pathogen not isolated from original site culture,or culture data not available for participant with successful clinical outcome.|End of Treatment (Day 14 to Day 42)|Modified Intent-To-Treat (MITT) population included all participants who received at least 1 dose of study drug and had a positive culture for Candida species (sp.).||percentage of participants||95% Confidence Interval|Number
782503|NCT00805766|Secondary|Antibody to TA-650 Determination||Weeks 24 and 40||||||
782504|NCT00805766|Secondary|Serum Concentration of TA-650 at Each Time Point||every 4 weeks for up to 40 weeks||||||
782508|NCT00805766|Primary|Median Crohn's Disease Activity Index (CDAI) Change From Week 0 to Week 8 in the Increased Dose Period|To confirm the decrease in median CDAI at week 8 by ≥ 50 points compared to the CDAI score at week 0 in the increased dose period. In the indication of CDAI change, decrease in CDAI was expressed by positive numbers. CDAI is a research tool used to quantify the symptoms of patients with Crohn’s disease. CDAI scores generally range from 0 to 600 points. Clinical remission = CDAI < 150 points. Moderate disease = CDAI 220 - 450 points. Severe disease = CDAI > 450 points.|Week 0 to Week 8|||units on a scale||95% Confidence Interval|Median
782509|NCT00805792|Secondary|Change in Time to Complete Neuropsychological Trail Making Tests A and B at 90 Days Post-stroke|The Trail-making test consists of two parts in which the subject is instructed to connect a set of 25 dots as fast as possible while still maintaining accuracy. It can provide information about visual search speed, scanning, speed of processing, mental flexibility, as well as executive functioning. There are two parts to the test: A, in which the targets are all numbers (1,2,3, etc.)and the test taker needs to connect them in sequential order, and B, in which the subject alternates between numbers and letters (1, A, 2, B, etc.).|baseline, 90 days post-stroke|||seconds||Standard Error|Mean
782510|NCT00805792|Secondary|Change in Mean Score on Mini Mental State Exam at 90 Days Post-stroke|The mini–mental state examination (MMSE) is a 30-point questionnaire test that is used to screen for cognitive impairment. The questionnaire samples functions including arithmetic, memory and orientation to time and place. Scores range from 0 to 30. Any score greater than or equal to 25 points is effectively normal (intact). Below this, scores can indicate severe (≤9 points), moderate (10-20 points) or mild (21-24 points) cognitive impairment.|baseline, 90 days post-stroke|||units on a scale||Standard Error|Mean
782511|NCT00805792|Secondary|Change in Mean Barthel Index of Activities of Daily Living Score at 90 Days Post-stroke|The Barthel Index of Activities of Daily Living (ADLs) measures functional disability by quantifying patient performance in 10 activities of daily life. These activities can be grouped according to self-care (feeding, grooming, bathing, dressing, bowel and bladder care, and toilet use) and mobility (ambulation, transfers, and stair climbing). 5-point increments are used in scoring, with a maximal score of 100 indicating that a patient is fully independent in physical functioning, and a lowest score of 0 representing a totally dependent bed-ridden state.|baseline, 90 days post-stroke|||units on a scale||Standard Error|Mean
782512|NCT00805792|Secondary|Change in Mean National Institutes of Health Stroke Scale (NIHSS) Score at 90 Days Post-stroke|The National Institutes of Health Stroke Scale (NIHSS) is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent’s ability to answer questions and perform activities. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items. The range of scores is from 0 (normal) to 42 (profound effect of stroke on patient).|baseline, 90 days post-stroke|||units on a scale||Standard Error|Mean
782513|NCT00805792|Primary|Percent of Participants With National Institutes of Health Stroke Scale (NIHSS) Score = 0 or 1 at Day 90|The National Institutes of Health Stroke Scale (NIHSS) is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent’s ability to answer questions and perform activities. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items. The range of scores is from 0 (normal) to 42 (profound effect of stroke on patient).|90 days post-stroke|Intention-to-treat analysis, all treated participants (n=33). Unobserved because of death (n=3) or loss to follow up (N=2) treated as nonresponse.||percentage of participants|||Number
782514|NCT00805870|Primary|Interleukin-6 Measured in Blood|Interleukin-6 is an indirect indicator of muscle inflammation.|6 days|Number of subjects that completed the protocol. Analysis was per protocol||pg/mL||Standard Deviation|Mean
782515|NCT00805870|Primary|Creatine Kinase Activity Measured in Blood|Creatine kinase activity is an indirect indicator of muscle damage.|6 days|Number of subjects that completed the protocol. Analysis was per protocol.||IU/L||Standard Deviation|Mean
782516|NCT00805870|Primary|Muscle Soreness of the Quadriceps Using an Algometer Strain Gauge|The required amount of force applied to the quadriceps to elicit pain or discomfort.|6 days|Number of subjects that completed the protocol. Analysis was per protocol.||lbs||Standard Deviation|Mean
782517|NCT00805870|Primary|Quadriceps Muscle Strength|Quadriceps muscle strength is the maximal amount of force that the quadriceps muscles can produce during isometric knee extension exercise.|6 days|Number of subjects that completed the protocol. Analysis was per protocol.||lbs||Standard Deviation|Mean
782518|NCT00805935|Secondary|Participants With Treatment Emergent Adverse Events|"Number of participants with adverse events (AEs) that started after first treatment. Severity used a three point scale:
mild=awareness of signs/symptoms, but no disruption of usual activity moderate=event sufficient to affect usual activity (disturbing) severe=event causes inability to work or perform usual activities (unacceptable) Relatedness to study treatment used a four point scale: unrelated, unlikely, possible, probable.
Seriousness refers to death, hospitalization, a life-threatening experience, persistent or significant disability/incapacity, or congenital anomaly."|Week 1 to week12|Safety population all randomized and treated participants. The safety population is identical intent-to- treat (ITT) population in this study||Participants|||Number
782519|NCT00805935|Secondary|Number of Live Births Resulting From the In Vitro Fertilization Process|Number of live births resulting from the IVF process|Approximately 10 months|Database was locked prior to most participants giving birth.||Live births|||Number
782520|NCT00805935|Secondary|Progesterone Levels at Human Chorionic Gonadotropin (hCG) Administration|Blood tests were sent to a central laboratory to obtain progesterone levels.|approximately day 16|||ng/mL||Standard Deviation|Mean
782521|NCT00805935|Secondary|Human Chorionic Gonadotropin (hCG) Levels at Day 6|Blood tests were sent to a central laboratory to obtain hCG levels.|Day 6|Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication||mIU/ml||Standard Deviation|Mean
782522|NCT00805935|Secondary|Estradiol Levels at Day 6|Estradiol monitoring during fertility therapy assesses follicular growth and is useful in monitoring the treatment. Blood tests sent to a central laboratory to obtain estradiol levels.|Day 6|Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication||pg/mL||Standard Deviation|Mean
782525|NCT00805935|Secondary|Percentage of Participants With Biochemical Pregnancy at Approximately Day 38|Biochemical pregnancy is a positive β-hCG pregnancy test 12-14 days post embryo transfer.|approximately day 38 (Day 14 post embryo transfer)|Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication||Percentage of participants|||Number
782526|NCT00805935|Secondary|Number of Embryos Frozen|The number of embryos that were not transferred but instead were frozen for future use.|approximately day 24|Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication||Embryos||Standard Deviation|Mean
782527|NCT00805935|Secondary|Number of Embryos Transferred at Three Stages of Development Before Implantation|"The number of embryos, morulas and blastocysts transferred to the study participant on either day 3 or day 5 following fertilization. Embryos represent the earliest development stage and contain 2-8 cells.
Morulas, the next stage, continued cellular cleavage results in a 16-30 cell solid sphere. Morula further develop into blastocyst, which contains 70-100 cells in a hollow spherical shape."|approximately day 24|Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication||Embryos||Standard Deviation|Mean
782528|NCT00805935|Secondary|Percentage of Oocytes Fertilized of the Total Number of Oocytes Retrieved|The fertilization rate for each participant was the percentage of the number of oocytes inseminated of the total number of oocytes retrieved.|approximately day 19|Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication||Percentage of oocytes retrieved|||Number
782529|NCT00805935|Secondary|Number of Oocytes Retrieved at Day 18|The mean number of oocytes retrieved approximately 36 hours after hCG (Novarel®) administration and fertilized (by insemination or intra cytoplasmic sperm injection (ICSI)) according to site-specific procedures.|approximately day 18|Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication||Oocytes||Standard Deviation|Mean
782530|NCT00805935|Secondary|Number of Follicles Observed at Day 15|The mean number of follicles observed in both ovaries at the last transvaginal ultrasound in the stimulation phase.|approximately day 15|Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication||Follicles||Standard Deviation|Mean
782531|NCT00805935|Primary|Participants With Cycle Cancellation Due to Risk of Ovarian Hyperstimulation Syndrome (OHSS) Between Weeks 1 - 3|A count of participants whose discontinuation was clearly documented on the study completion/termination form as cycle cancellation for risk of ovarian hyperstimulation syndrome (OHSS).|weeks 1-3|Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication||Participants|||Number
782532|NCT00805961|Secondary|To Assess the Complete Response Rate of Patients With Glioblastoma Multiforme Following Treatment With This Novel Multimodality Regimen||18 months||||||
782533|NCT00805961|Secondary|To Assess the Overall Survival of Patients With Glioblastoma Multiforme Following Treatment With This Novel Multimodality Regimen||18 months|||Months||95% Confidence Interval|Number
782534|NCT00805961|Secondary|To Assess the Toxicity of This Novel Multimodality Regimen||18 months|Information provided in the AEs section|||||
782535|NCT00805961|Primary|Progression-free Survival (PFS)||18 months|||Months||95% Confidence Interval|Median
782536|NCT00806026|Secondary|Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP) at Week 12|WPAI: 6 question participant rated questionnaire to determine degree to which SHP affected work productivity while at work and outside of work. Four scores are derived: percentage of absenteeism and presenteeism (reduced productivity while at work), overall work impairment score combining absenteeism and presenteeism, percentage of impairment in activities performed outside of work. Score range: 0 (not affected/no impairment) to 10 (completely affected/impaired). WPAI outcomes expressed as impairment percentages with higher numbers indicating greater impairment and less productivity.|Week 12|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, 'n' is signifying those participants who were evaluable for particular category for each group respectively.||Percentage of impairment||Standard Deviation|Mean
782537|NCT00806026|Secondary|Medical Outcomes Study-Short Form 36 (SF-36) at Week 12|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being (physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health); 2 summary scores (physical and mental component); and self evaluated change in health status (summary of health status). The score for subscale scores and 2 summary score is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Summary of health status is a 5-point Likert scale ranging from “0=much worse now” to “4=much better now”. Higher subscale and summary score reflect better health status.|Week 12|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.||Units on a Scale||Standard Deviation|Mean
782538|NCT00806026|Secondary|Restless Legs Syndrome-Quality of Life Scale (RLS-QoL) at Week 12|RLS QoL: Participant rated instrument used to assess the impact of RLS on quality of life and health status function (symptom severity, daily activity, social functioning, sleep, concentrating and decision making, traveling, sexual activity, and work) yielding a summary score ranging from 0-100. Higher scores reflect better quality of life.|Week 12|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.||Units on Scale||Standard Deviation|Mean
782539|NCT00806026|Secondary|Profile of Mood State (POMS) at Week 12|POMS are participant-rated instrument comprising 6 sub-scales (tension-anxiety, depression-dejection, anger-hostility, vigor-activity, fatigue-inertia, and confusion-bewilderment) and each subscale comprising 5 items, on ‘How you feel right now?’ (Scale: 0=not at all, 1=a little, 2=moderately, 3=quite a bit, 4=extremely). All items were rated in the same direction except for vigor-activity. A total score is obtained for each scale. The range of total score is 0 – 100, with higher score indicating more mood disturbance.|Week 12|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to lack of sufficient knowledge as how to analyze mood data inferentially in RLS population.|||||
782540|NCT00806026|Secondary|Number of Participants With Medical Outcomes Study-Sleep Scale (MOS-SS)- Optimal Sleep at Week 12|MOS-SS: Participant rated instrument to assess sleep quantity, quality; comprised of 12 items yielding 7 subscale scores: sleep disturbance, snoring, awakening short of breath/ headache, sleep adequacy, somnolence, sleep quantity, optimal sleep, 2 composite index scores: sleep problems Index I, II. Optimal sleep subscale scores range: 0-1; Optimal sleep = 1 if 'Average hours sleep' = 7 or 8, is 0 if 'Average hours sleep' is non-missing and less than 7, and is missing if 'Average hours sleep' is missing. Higher scores reflect better sleep outcomes.|Week 12|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.||Participants|||Number
782541|NCT00806026|Secondary|Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 12|MOS-SS: Participant rated instrument to assess sleep quantity, quality; comprised of 12 items yielding 7 subscale scores: sleep disturbance, snoring, awakening short of breath/headache, sleep adequacy, somnolence, sleep quantity, optimal sleep, 2 composite index scores: sleep problems Index I, II. Sleep adequacy data was reported at week 12 and not for first 12 weeks (average). Subscale scores range: 0-100; exception quantity of sleep (range 0-24 hours). With exception of sleep quantity and sleep adequacy, higher scores reflect poorer sleep outcomes.|Week 12|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, 'n' is signifying those participants who were evaluable for particular category for each group respectively.||Units on a Scale||Standard Deviation|Mean
782542|NCT00806026|Secondary|Clinical Global Impressions-Severity (CGI-S) at Week 12|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal-not ill at all) to 7 (among the most extremely ill participants). Higher score = more affected.|Week 12|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.||Units on a Scale||Standard Deviation|Mean
782543|NCT00806026|Secondary|Severity of Augmentation Symptoms at Week 12|ASRS measures severity of augmentation and consist of three items to be completed by clinician. Clinician would score participants’ answers by comparing post-baseline evaluations to those at baseline. ASRS total score range: 0-24, with higher score indicating more severe augmentation.|Week 12|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.||Units on a Scale||Standard Deviation|Mean
782544|NCT00806026|Secondary|Change From Baseline in Limb Pain-VAS at Week 12|100 mm line (VAS) marked by participant. Intensity of pain range (over past week): 0 mm = no pain to 100 mm = worst possible pain. Change = observation mean minus baseline mean.|Baseline, Week 12|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.||mm||Standard Error|Least Squares Mean
782545|NCT00806026|Secondary|Limb Pain-Visual Analog Scale (Limb Pain-VAS)|100 millimeter (mm) line (Visual Analog Scale) marked by participant. Intensity of pain range (over past week): 0 mm = no pain to 100 mm = worst possible pain.|Baseline|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.||mm||Standard Deviation|Mean
782546|NCT00806026|Secondary|Change From Baseline in RLS-NDI at Week 12|The RLS-NDI is a participant-rated instrument designed to assess daytime performance as related to RLS and the participant’s previous night’s sleep. The instrument consists of 14 items that encompass 5 domains: tiredness; emotional functioning; social functioning; cognitive functioning; and activities of daily living. There is also 1 global item assessing overall well -being. Each item is scored on a 0-10 numeric rating scale. Total score is the sum of scores from question 1 to 14. The total score ranges from 0 to 140 where higher scores indicate a more severe impact.|Baseline, Week 12|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.||Units on a Scale||Standard Error|Least Squares Mean
782547|NCT00806026|Secondary|RLS-Next Day Impact (RLS-NDI)|The RLS-NDI is a participant-rated instrument designed to assess daytime performance as related to RLS and the participant’s previous night’s sleep. The instrument consists of 14 items that encompass 5 domains: tiredness; emotional functioning; social functioning; cognitive functioning; and activities of daily living. There is also 1 global item assessing overall well -being. Each item is scored on a 0-10 numeric rating scale. Total score is the sum of scores from question 1 to 14. The total score ranges from 0 to 140 where higher scores indicate a more severe impact.|Baseline|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.||Units on a Scale||Standard Deviation|Mean
782548|NCT00806026|Secondary|Subjective Sleep Questionnaire (SSQ): Quality of Sleep Subscale Score at Week 12|SSQ: Participant-rated instrument used to assess previous night’s sleep profile. It is used to measure sleep quantity and quality and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), total WASO (1 item), quality of sleep (1 item). Quality of sleep subscale: numerical rating completed by the participant 30 minutes after waking; recall period is the night before. Quality of sleep subscale score ranges from 0-100. Higher score indicates better quality of sleep.|Week 12|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.||Units on a scale||Standard Deviation|Mean
782549|NCT00806026|Secondary|Subjective Sleep Questionnaire (SSQ): Number of Awakenings Subscale Score at Week 12|SSQ: Participant-rated instrument used to assess previous night’s sleep profile. It is used to measure sleep quantity and quality and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), total WASO (1 item), quality of sleep (1 item). Number of awakenings subscale: numerical rating completed by the participant 30 minutes after waking; recall period is the night before. Number of awakenings subscale score ranges from 0-30. Lower value indicates better sleep.|Week 12|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.||awakenings||Standard Deviation|Mean
782550|NCT00806026|Secondary|Subjective Sleep Questionnaire (SSQ): Hours of Sleep Subscale Score at Week 12|SSQ: Participant-rated instrument used to assess previous night’s sleep profile. It is used to measure sleep quantity and quality and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), total WASO (1 item), quality of sleep (1 item). Hours of sleep subscale: numerical rating completed by the participant 30 minutes after waking; recall period is the night before. Hours of sleep subscale score ranges from 0-16 hours. Higher value indicates better sleep.|Week 12|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.||hours||Standard Deviation|Mean
782551|NCT00806026|Secondary|Subjective Sleep Questionnaire (SSQ): Latency Subscale Score at Week 12|SSQ: Participant-rated instrument used to assess previous night’s sleep profile. It is used to measure sleep quantity and quality and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), total WASO (1 item), quality of sleep (1 item). Latency subscale (in minutes): numerical rating completed by the participant 30 minutes after waking; recall period is the night before. Latency subscale score ranges from 0-840 minutes. Lower value indicates better sleep.|Week 12|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.||minutes||Standard Deviation|Mean
782552|NCT00806026|Secondary|Change From Baseline in SSQ: Subjective WASO at Week 12|SSQ: Participant-rated instrument used to assess previous night’s sleep profile. It is used to measure sleep quantity and quality and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), total WASO (1 item), quality of sleep (1 item). WASO is time spent awake from sleep onset to final awakening. Total WASO subscale (in minutes): numerical rating completed by the participant 30 minutes after waking; recall period is the night before. Total WASO subscale score ranges from 0-1440 minutes. Lower value indicates better sleep.|Baseline, Week 12|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.||minutes||Standard Error|Least Squares Mean
782553|NCT00806026|Secondary|Subjective Sleep Questionnaire (SSQ): Subjective Waking After Sleep Onset (WASO)|SSQ: Participant-rated instrument used to assess previous night’s sleep profile. It is used to measure sleep quantity and quality and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), total WASO (1 item), quality of sleep (1 item). WASO is time spent awake from sleep onset to final awakening. Total WASO subscale (in minutes): numerical rating completed by the participant 30 minutes after waking; recall period is the night before. Total WASO subscale score ranges from 0-1440 minutes. Lower value indicates better sleep.|Baseline|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.||minutes||Standard Deviation|Mean
782554|NCT00806026|Primary|Percentage of Participants With Augmentation|Augmentation was worsening of RLS symptoms, attributable to a specific long-term therapeutic intervention for RLS. Percentage of participants with augmentation was evaluated by centralized evaluation board using a set of assessment criteria for potential augmentation which included structured interview for diagnosis of augmentation during RLS treatment (SIDA-RLS), augmentation severity rating scale (ASRS), clinical judgment. ASRS measures severity of augmentation and consist of three items to be completed by clinician. Clinician would score participants’ answers by comparing post-baseline evaluations to those at baseline. ASRS total score range: 0-24, with higher score indicating more severe augmentation.|Baseline up to Week 52|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.||Percentage of participants|||Number
782555|NCT00806026|Primary|Percentage of Participants Responding to Treatment at Week 12|"CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. Responders were defined as participants who report CGI-I score of very much improved or much improved."|Week 12|ITT population. Last observation carried forward (LOCF) method was used. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.||Percentage of participants|||Number
782556|NCT00806026|Primary|Change From Baseline in the RLS Symptom Severity at Week 12|IRLS is psychometrically and clinically valid and reliable clinician-administered instrument used to assess the severity of RLS. It assesses RLS symptom severity and impact on daily living and is comprised of 10 items, scored on 0 to 4 scale, where lower score indicates lower symptom severity/impact on living. Two subscale scores are symptom severity (6 items) ranging from 0-24 (lower score indicates lower symptom severity) and impact on daily living (3 items) ranging from 0-12 (lower score indicates lower impact on living). Item 3 is unrelated to the other items. The global score is calculated from all 10 items, range from 0 to 40, where lower scores reflect lower severity and better quality of life.|Baseline, Week 12|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.||Units on a Scale||Standard Error|Least Squares Mean
782557|NCT00806026|Primary|Restless Legs Syndrome (RLS) Symptom Severity|International Restless Legs Syndrome Study Group Rating Scale (IRLS) is psychometrically and clinically valid and reliable clinician-administered instrument used to assess the severity of RLS. It assesses RLS symptom severity and impact on daily living and is comprised of 10 items, scored on 0 to 4 scale, where lower score indicates lower symptom severity/impact on living. Two subscale scores are symptom severity (6 items) ranging from 0-24 (lower score indicates lower symptom severity) and impact on daily living (3 items) ranging from 0-12 (lower score indicates lower impact on living). Item 3 is unrelated to the other items. The global score is calculated from all 10 items, range from 0 to 40, where lower scores reflect lower severity and better quality of life.|Baseline|Intent-to-treat (ITT) population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.||Units on a Scale||Standard Deviation|Mean
782558|NCT00806078|Primary|The Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity. (AUC Inf)|AUC inf is calculated as the sum of the AUC 0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant.It is calculated to evaluate the bioequivalence of the two dosing methods|After dosing at time points 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, and 48 hours|Analysis was performed per protocol||ng-h/ml||Standard Deviation|Mean
782559|NCT00806078|Primary|Area Under the Concentration Time Curve From Zero to t. (AUC 0-t)|The area under the plasma concentration versus time curve from zero to the last measurable plasma concentration as calculated by the linear trapezoidal method. Calculated to determine whether the 2 methods of administration are bioequivalent.|After dosing at time points 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, and 48 hours|Analysis was performed per protocol||ng·h/mL||Standard Deviation|Mean
782560|NCT00806078|Primary|Maximum Observed Plasma Concentration (Cmax)|The highest concentration of drug in plasma after a dose. Measured to evaluate the bioequivalence of the two dosing methods|After dosing at time points 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, and 48 hours|Analysis was performed per protocol||ng per mL||Standard Deviation|Mean
782561|NCT00806195|Secondary|Number of Subjects Who Reported Unsolicited Adverse Events After Any Vaccination|Safety data with medically attended events were collected throughout the study in the non-detailed safety groups and from Day 8 onwards for the detailed safety groups.|Day 1 (2 months of age) to 18 months of age|Analysis was done on as treated safety population.||Subjects|||Number
782562|NCT00806195|Secondary|Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination|To compare the percentage of subjects who reported local and systemic solicited adverse events from day 1 to day 7 after each vaccination with MenACWY-CRM197 given concomitantly with routine vaccinations to the routine vaccinations alone group.|15 minutes to Day 7|Analysis was done on as treated safety population.||percentages of subjects|||Number
782563|NCT00806195|Secondary|Percentages of Subjects With At Least One Serious Adverse Event During the Entire Study Period|To compare the percentages of subjects presenting at least one serious adverse event (SAE) through 6 months post-final dose in subjects who received MenACWY-CRM197 vaccine concomitantly with routine vaccinations to the percentages of subjects who received routine vaccinations alone.|Day 1 (2 months of age) to 18 months of age|Analysis was done on as treated safety population.||Percentages of subjects|||Number
782564|NCT00806195|Primary|Percentages of Subjects With At Least One Severe Systemic Reaction After Any Vaccination|"To compare the percentages of subjects who reported at least one severe systemic reaction after any vaccination of MenACWY-CRM197 (detailed) plus routine vaccines (detailed) group to that observed in the routine vaccines alone (detailed) group administered at 2, 4, 6, and 12 months of age.
Detailed - infants who provided reactogenicity and all Adverse Events (AEs) for 7 days, Serious Adverse Events (SAEs) and medically attended AEs."|15 minutes to Day 7 after any vaccination administered at 2, 4, 6 and 12 months of age|Analysis was done on As Treated Safety Population - Subjects who received at least one study dose and provided postbaseline safety data, and that subjects would be included in the group for the vaccination actually received (i.e., analyzed as treated).||Percentages of subjects|||Number
782565|NCT00806221|Secondary|Development of Eczema||1 and 2 year time points|||Participants|||Count of Participants
782566|NCT00806221|Primary|Compliance With Protocol||over two years|||participants|||Number
782567|NCT00806221|Primary|Incidence of Skin Infection||1 and 2 year timepoints|||Participants|||Count of Participants
782568|NCT00806221|Primary|Incidence of Skin Irritation||1 and 2 year time points|||Participants|||Count of Participants
782569|NCT00806234|Secondary|Change in Low Density Lipoprotein (LDL) Cholesterol Level||From Baseline to Week 24|||mg/dL||Standard Error|Least Squares Mean
782570|NCT00806234|Secondary|Triglyceride Levels||Change from baseline to 24 weeks|||mg/dL||Standard Error|Least Squares Mean
782571|NCT00806234|Secondary|Change in Whole Body Insulin Sensitivity Index||Change from baseline to 24 weeks|||mU/L||Standard Error|Least Squares Mean
782572|NCT00806234|Primary|Body Mass Index (BMI) Z-score Change||Change from baseline to 24 weeks|||Z Score||Standard Error|Least Squares Mean
782950|NCT00815659|Secondary|Interleukin 1 (IL-1) Level After 3 Months of Rosuvastatin Treatment|IL-1 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF (Last Observation Carried Forward) IL-1 levels of participants||pg/mL||Standard Deviation|Mean
782573|NCT00806260|Primary|Measure of Psychomotor Function Using Speed and Coordination on the CogScreen Pathfinder Number (PFN) Test in Subjects Treated With VI-0521 Compared to Placebo in Periods 2 and 3.|"CogScreen-Psychomotor Edition (CogScreen-PM) consists of a series of computerized cognitive tasks, each self-contained and presented with instructions and a practice segment. The test battery takes about 20-25 minutes to perform. Performance on the test will be measured as the median reaction time for correct responses (PFNRTC) and coordination errors (PFNCOOR) before and after treatment. The measures of the tests are:
(a) response speed, the median response time to complete each sequential step (PFNRTC); (b) response accuracy (PF Number Accuracy [PFNACC]); and (c) a coordination measure indicating the respondent’s proximity to the center of the target numbers and letters (PF Number Coordination [PFNCOOR]). PF measures number sequencing skills, immediate memory, psychomotor speed and coordination, and visual scanning.
The normal range for PFN scores is 1.17-2.16. Scores that are higher than this range indicate some level of psychomotor impairment."|Hour 2 and Hour 6|Intent-to-treat (ITT) ITT population includes participants who completed Periods 1, 2 and 3. Subjects that were discontinued due to adverse events, failed drug/alcohol screens, non-compliance, etc. are not included in this analysis.||scores on a scale||Standard Error|Least Squares Mean
782574|NCT00806260|Primary|Measure of Psychomotor Function Using Speed and Coordination on the CogScreen Pathfinder Number (PFN) Test in Subjects Treated With Alcohol Compared to Alcohol Placebo in Period 1.|"CogScreen-Psychomotor Edition (CogScreen-PM) consists of a series of computerized cognitive tasks, each self-contained and presented with instructions and a practice segment. The test battery takes about 20-25 minutes to perform. Performance on the test will be measured as the median reaction time for correct responses (PFNRTC) and coordination errors (PFNCOOR) before and after treatment. The measures of the tests are:
(a) response speed, the median response time to complete each sequential step (PFNRTC); (b) response accuracy (PF Number Accuracy [PFNACC]); and (c) a coordination measure indicating the respondent’s proximity to the center of the target numbers and letters (PF Number Coordination [PFNCOOR]). PF measures number sequencing skills, immediate memory, psychomotor speed and coordination, and visual scanning.
The normal range for PFN scores is 1.17-2.16. Scores that are higher than this range indicate some level of psychomotor impairment."|at breath alcohol levels 0.10%, 0.07%, and 0.04%|modified-intent-to-treat (mITT)||scores on a scale||Standard Error|Least Squares Mean
782589|NCT00806390|Primary|Ejection Fraction by MUGA|Because of the inability to enroll an adequate number of patients, (only 15 out of a planned 50) no data analysis was collected or performed.|Pre and post anthracycline treatment||||||
782590|NCT00806403|Secondary|Stroke||30 days|Analysis made on intention to treat (ITT) basis.||Participants|||Number
782591|NCT00806403|Secondary|Reinfarction||30 days|Analysis made on intention to treat (ITT) basis.||Participants|||Number
782592|NCT00806403|Primary|Number of Patients With Thrombolysis In Myocardial Infarction (TIMI) Flow Grade 3|Thrombolysis In Myocardial Infarction (TIMI) flow grade in the infarct related artery 5-7 days after inclusion.|5-7 days after inclusion|Patient were analyzed on intention to treat (ITT) basis. The per protocol angiography on day 5-7 after inclusion was used for analysis of Thrombolysis In Myocardial Infarction (TIMI) flow grade in the infarct related coronary artery.||participants|||Number
782593|NCT00806403|Secondary|Death||30 days|Analysis was made on intention to treat (ITT) basis.||participants|||Number
782594|NCT00806403|Primary|Number of Patients With ST-segment Elevation Resolution Equal or More Than 50%|ST-segment elevation resolution was measured in the lead with most prominent ST elevation at time of inclusion|120 minutes after inclusion|Analysis was made on intention to treat(ITT) basis.Patients with electrocardiograms (ECGs) suitable for analysis at inclusion and at 120 minutes therafter were included in the analysis.||participants|||Number
782595|NCT00806416|Primary|Part II : The Pharmacokinetic Parameters Cmax of Vitamin D in Combination Tablet Relative to Vitamin D Tablet|Serum vitamin D3 pharmacokinetic parameter Cmax (maximum concentration observed in serum) after treatmen on Day 1was calculated following single-dose administration of a 70 mg alendronate/2800-IU vitamin D3 combination tablet or 2800-IU vitamin D3 tablet. Serum for each treatment period was collected at -24, -18, -12, -6, and 0 hours predose, and 2, 3, 5, 7, 9, 12, 16, 24, 36, 48, 72, 96, and 120 hours postdose.|On Day 1 across the 120-hour plasma collection period (Periods 1 and 2).|||ng/mL||Standard Deviation|Least Squares Mean
782951|NCT00815659|Secondary|Basal Interleukin 1 (IL-1) Level|IL-1 levels before (Visit 2-enrollment)|Baseline|Baseline IL-1 levels of participants||pg/mL||Standard Deviation|Mean
782596|NCT00806416|Primary|Part II : The Pharmacokinetic Parameters AUC0-120 hr of Vitamin D in Combination Tablet Relative to Vitamin D Tablet|"Serum vitamin D3 pharmacokinetic parameter AUC0-120 hr (area under the serum concentration-time curve) after treatment on Day 1was calculated following single-dose administration of a 70 mg alendronate/2800-IU vitamin D3 combination tablet or 2800-IU vitamin D3 tablet.
Serum for each treatment period was collected at -24, -18, -12, -6, and 0 hours predose, and 2, 3, 5, 7, 9, 12, 16, 24, 36, 48, 72, 96, and 120 hours postdose."|On Day 1 across the 120-hour plasma collection period (Periods 1 and 2).|Twenty-eight (28) subjects (excluding 2 that were enrolled but did not complete both study periods) were included in the statistical analysis.||ng*hr/mL||Standard Deviation|Least Squares Mean
782597|NCT00806416|Primary|Part 1: The Total Urinary Excretion of Alendronate With Alendronate/Vitamin D Combination Tablet Relative to Alendronate Tablet|Urinary excretion of alendronate was determined over a 36-hour period following single-dose administration of a 70 mg alendronate/2800-IU vitamin D3 combination tablet or 70 mg alendronate alone tablet. Urine for each treatment period was collected at -2 to 0 hours predose, 0 to 8, 8 to 24, and 24 to 36 hours postdose.|On Day 1 across the 36-hour urinary collection period (Periods 1 and 2).|Two hundred-seven (207) subjects (excluding 7 that were enrolled but did not complete both study periods) were included in the statistical analysis.||micrograms (μg)||Standard Deviation|Least Squares Mean
782598|NCT00806442|Secondary|Urinary Leukotriene Levels|Urinary leukotriene levels in plant seed oil vs. placebo|6 weeks|one participant was missing some urinary leukotriene data||ng/ml||95% Confidence Interval|Mean
782599|NCT00806442|Secondary|Night-time Wakenings|Average number of night-time wakenings in plant seed oil vs. placebo|6 weeks|one participant is missing some night-time wakening data||average number of night-time wakenings||95% Confidence Interval|Mean
782600|NCT00806442|Secondary|Day-time Symptoms of Bronchial Asthma|"Day-time symptom scores in plant seed oil vs. placebo. 0 = Absent: No symptoms
= Mild: Symptom did not interfere with normal daily activity or sleep
= Moderate: Symptom was sufficient to interfere with normal daily activity or sleep
= Severe: Symptom was so severe as to prevent normal daily activity or sleep
These numbers were used for 1. Shortness of breath 2. Chest tightness 3. Wheezing 4. Cough 5. Phlegm/Mucus.
The total score is the sum of the 5 item scores, for a range of 0-15. A higher score represents more severe symptoms. Each participant's score is the average of varying numbers of diary cards. The treatment phase visits at 6 weeks consisted of 3 weeks of diary cards with a +/- 5 day window. The baseline visits had 2 weeks of diary cards with a +/- 5 day window. The treatment phase measures are adjusted for the baseline measures."|6 weeks|||units on a scale||95% Confidence Interval|Mean
782601|NCT00806442|Secondary|Frequency of Rescue Use of Short Acting Beta-2 Agonists|Average number of puffs of albuterol daily in plant seed oil vs. placebo|6 weeks|one participant is missing some data on this measure||Avg number of puffs of albuterol daily||95% Confidence Interval|Mean
782602|NCT00806442|Secondary|Peak Flow Rate (PEFR)|Morning Peak Flow Rate in plant seed oil vs. placebo|6 weeks|||liters/minute||95% Confidence Interval|Mean
782603|NCT00806442|Secondary|Positive FEV1 Percent Predicted Change Among C Allele Carriers and A Homozygotes|Number of participants with positive change in FEV1 % predicted (>0%) among C allele carriers and A homozygotes in each arm|6 weeks on each treatment assignment|Patients who are C allele carriers or A homozygotes||Participants|||Count of Participants
782604|NCT00806442|Primary|Forced Expiratory Volume in 1 Second (FEV1)|Forced expiratory volume in 1 second (FEV1) in plant seed oil vs. placebo|6 weeks|Includes participants that completed the study.||liters||95% Confidence Interval|Mean
782605|NCT00806494|Secondary|Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12|KHQ: Self-administered questionnaire containing 21 questions scored in 9 domains (general health perception, incontinence impact, role limitations, physical limitations, social limitations, personal relationships, emotions, sleep/energy, severity of urinary symptoms). Each domain was a categorical scale that was converted to a numeric score. All domains transformed to a range of 0 to 100, where 0=best outcome/response and 100=worst outcome/response. Change=mean score at Week 12 minus mean score at baseline, negative change from baseline=improvement.|Baseline, Week 12|FAS. n=number of participants with analyzable data.||Score on Scale||95% Confidence Interval|Mean
782606|NCT00806494|Secondary|Percentage of Participants Reporting Satisfaction on the Treatment Satisfaction Questionnaire (TSQ) at Week 12|TSQ: Independent component of the overactive bladder TSQ. Self- administered, 1-item measure of participant satisfaction for participants receiving treatment for OAB. The 5 categorical responses were grouped to ‘Satisfied’ (including ‘very satisfied’ and ‘somewhat satisfied’) and ‘Dissatisfied’ (including ‘very dissatisfied’,‘somewhat dissatisfied’, and ‘neither dissatisfied nor satisfied’). Percentage of participants reporting satisfaction included those with categorical responses of ‘very satisfied’ and ‘somewhat satisfied’.|Week 12 (or Early Withdrawal)|FAS. N=number of participants with analyzable data.||Percentage of Participants|||Number
782607|NCT00806494|Secondary|Number of Participants With Each Categorical Response at Week 12 for Benefit, Satisfaction and Willingness to Continue (BSW) Questionnaire|BSW: 3-item questionnaire to assess participants perception of effect of treatment in terms of treatment benefit, satisfaction with treatment, and participants willingness to continue treatment. Response to each item recorded in dichotomous fashion (Benefit: yes/no, yes - little benefit/much benefit; Satisfaction: yes/no, yes - a little satisfied/very satisfied, no - a little dissatisfied/very dissatisfied; Willingness to continue: yes/no, yes - a little bit willing/very willing, no - a little unwilling/very unwilling).|Week 12 (or Early Withdrawal)|FAS, LOCF.||Participants|||Number
782608|NCT00806494|Secondary|Change From Baseline in the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) Score at Week 12|ICIQ-SF: self-administered questionnaire for assessment and quantification of incontinence and its impact on quality of life. ICIQ score=sum of the responses to 3 questions: How often do you leak urine? (range: 0=never to 5=all the time); How much urine do you usually leak? (range: 0=none to 6=a large amount); Overall, how much does leaking urine interfere with your everyday life? (range: 0=not at all to 10=a great deal). Score range=0 (low bother from urine leakage) to 21 (maximum bother). Negative change (decrease) from baseline in score value=reduced level of bother.|Baseline, Week 12|FAS. N=number of participants with analyzable data.||Score on Scale||95% Confidence Interval|Mean
782738|NCT00807846|Secondary|Change From Baseline in DBP at Week 4.|Value at 4 weeks minus value at baseline.|4 weeks|"Safety population included all randomized participants who received at least one dose of study medication. The Safety Analysis set was used to analyze all BP measurements.
For early terminations the LOCF was used to impute missing data."||mmHg||Standard Error|Least Squares Mean
782609|NCT00806494|Secondary|Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Weeks 4 and 12|OAB-q symptom bother scale (8 items) is part of the OAB-q. Symptom bother score=sum of scores for items 1 to 8 (each symptom bother item measured on 6-point Likert scale ranging from 1 (not at all) to 6 (a very great deal). Lowest possible raw score=8; highest possible score=48. Data analyzed based on transformation of score to a 0 to 100 scale: (Actual total raw score - lowest possible value of raw score)/raw score range * 100. 0=no symptom bother, 100=high symptom bother. Change=mean score at observation minus mean score at baseline, negative change in score=improvement.|Baseline, Week 4 and Week 12|FAS. N=number of participants with baseline score. n=number of participants analyzed at specified timepoint. Missing data at Week 12 imputed using LOCF approach.||Score on Scale||95% Confidence Interval|Mean
782610|NCT00806494|Secondary|Change From Baseline in Urgency Perception Scale (UPS) at Weeks 4 and 12|UPS: self-administered, single-item questionnaire to measure participant’s perception of urinary urgency (rated on 3-point scale: 1=usually not able to hold urine; 3=usually able to finish what I am doing before going to toilet without leaking). Score change=score at observation minus score at baseline; re-scaled to 3-point categorical variables (improvement [Increase of 1 or more points in difference of scores]; no change [score difference=0]; deterioration [Negative difference of scores], based on UPS score, with number of participants in each of the 3-point categories.|Baseline, Week 4 and Week 12|FAS; n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.||Participants|||Number
782611|NCT00806494|Secondary|Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Weeks 4 and 12|PPBC: self-administered, single-item, questionnaire to describe perception of participants bladder-related problems (rated on 6-point scale: 1=no problems at all, 2=some very minor, 3=some minor, 4=some moderate, 5=severe, 6=many severe problems). Score change=score at observation minus score at baseline; re-scaled to 4-point categorical variables (major improvement [score difference <=-2]; minor improvement [score difference =-1]; no change [score difference = 0]; deterioration [score difference >=1]), based on PPBC score.|Baseline, Week 4 and Week 12|FAS; n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.||Participants|||Number
782612|NCT00806494|Secondary|Change From Baseline in Mean Number of Incontinence Pads Used Per 24 Hours at Weeks 4 and 12|The mean number of incontinence pads used per 24 hours was calculated as the total number of incontinence pads used divided by the total number of diary days collected at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of incontinence pads used relative to baseline=improvement.|Baseline, Week 4 and Week 12|FAS. n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.||Number of Incontinence Pads||95% Confidence Interval|Mean
782613|NCT00806494|Secondary|Percentage Change From Baseline in SUEs Per 24 Hours at Weeks 4 and 12|Percentage change from baseline in SUEs was calculated as the change in mean number of SUEs per 24 hours at that visit divided by the baseline mean number of SUEs per 24 hours, multiplied by 100.|Baseline, Week 4 and Week 12|FAS; participants reporting this symptom at baseline (participants with SUEs >0 per 24 hours during the 3-day baseline diary period. n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.||Percentage Change||95% Confidence Interval|Mean
782614|NCT00806494|Secondary|Change From Baseline in Mean Number of Severe Urgency Episodes (SUEs) Per 24 Hours at Weeks 4 and 12|SUEs were defined as those with a USS rating of >=4 in the diary. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Mean number of SUEs per 24 hours was calculated as total number of SUEs divided by total number of diary days collected at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of SUEs relative to baseline=improvement.|Baseline, Week 4 and Week 12|FAS; participants reporting this symptom at baseline (participants with SUEs >0 per 24 hours during the 3-day baseline diary period). n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.||Number of Episodes||95% Confidence Interval|Mean
782615|NCT00806494|Secondary|Percentage Change From Baseline in NUEs Per 24 Hours at Weeks 4 and 12|Percentage change from baseline in NUEs was calculated as change in mean number of NUEs per 24 hours at that visit divided by the baseline mean number of NUEs per 24 hours, multiplied by 100.|Baseline, Week 4 and Week 12|FAS; participants reporting this symptom at baseline (participants with NUEs >0 per 24 hours during the 3-day baseline diary period). n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.||Percentage Change||95% Confidence Interval|Mean
782616|NCT00806494|Secondary|Change From Baseline in Mean Number of Nocturnal Urgency Episodes (NUEs) Per 24 Hours at Weeks 4 and 12|"NUEs were defined as those with a USS rating of >=3 in the diary, occurring between the time the participant goes to bed and the time he/she arises to start the next day. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine).
Mean number of NUEs per 24 hours was calculated as total number of NUEs divided by total number of diary days collected at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of NUEs relative to baseline=improvement."|Baseline, Week 4 and Week 12|FAS; participants reporting this symptom at baseline (participants with NUEs >0 per 24 hours during the 3-day baseline diary period). n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.||Number of Episodes||95% Confidence Interval|Mean
782617|NCT00806494|Secondary|Percentage Change From Baseline in Urgency Episodes Per 24 Hours at Weeks 4 and 12|Percentage change from baseline in urgency episodes was calculated as change in mean number of urgency episodes per 24 hours at that visit divided by the baseline mean number of urgency episodes per 24 hours, multiplied by 100.|Baseline, Week 4 and Week 12|FAS; participants reporting this symptom at baseline (participants with urgency episodes >0 per 24 hours during the 3-day baseline diary period). n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.||Percentage Change||95% Confidence Interval|Mean
782628|NCT00806585|Secondary|Change From Baseline in Body Weight at Week 24|Fasting weight was assessed at baseline and after 24 weeks of study drug administration and was measured after voiding, with shoes and socks off, wearing clinic gown to reduce variability and maintain consistency. Same standardized digital scale was used throughout the study.|Baseline and Week 24|Full Analysis Set (FAS) Population defined as all participants who received at least 1 dose of study drug and had endpoint data (both baseline and post-randomization)||kg||Standard Error|Least Squares Mean
782618|NCT00806494|Secondary|Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Weeks 4 and 12|Urgency episodes were defined as those with a USS rating of >=3 in the diary. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Mean number of urgency episodes per 24 hours was calculated as total number of urgency episodes divided by total number of diary days collected at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of urgency episodes relative to baseline=improvement.|Baseline, Week 4 and Week 12|FAS; participants reporting this symptom at baseline (number of participants with urgency episodes >=3 per 24 hours during the 3-day baseline diary period). n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.||Number of Episodes||95% Confidence Interval|Mean
782619|NCT00806494|Secondary|Percentage Change From Baseline in UUI Episodes Per 24 Hours at Weeks 4 and 12|Percentage change from baseline in UUI episodes was calculated as change in mean number of UUI episodes per 24 hours at that visit divided by the baseline mean number of episodes per 24 hours, multiplied by 100.|Baseline, Week 4 and Week 12|FAS; participants reporting this symptom at baseline (number of participants with UUI episodes >0 per 24 hours during the 3-day baseline diary period). n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.||Percentage Change||95% Confidence Interval|Mean
782620|NCT00806494|Secondary|Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 4 and 12|"UUI episodes were defined as those with a Urinary Sensation Scale (USS) rating of 5 in the diary. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine).
Mean number of UUI episodes per 24 hours was calculated as total number of micturitions with USS rating of 5 divided by total number of diary days collected at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of UUI episodes relative to baseline=improvement."|Baseline, Week 4 and Week 12|FAS; participants reporting this symptom at baseline (number of participants with UUI episodes >0 per 24 hours during the 3-day baseline diary period). n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.||Number of Episodes||95% Confidence Interval|Mean
782621|NCT00806494|Secondary|Percentage Change From Baseline in Nocturnal Micturitions Per 24 Hours at Weeks 4 and 12|Percentage change from baseline in nocturnal micturitions was calculated as change in mean number of nocturnal micturitions per 24 hours at that visit divided by the baseline mean number of nocturnal micturitions per 24 hours, multiplied by 100.|Baseline, Week 4 and Week 12|FAS; participants reporting this symptom at baseline (participants with nocturnal >0 micturitions per 24 hours during the 3-day baseline diary period). n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.||Percentage Change||95% Confidence Interval|Mean
782622|NCT00806494|Secondary|Change From Baseline in Mean Number of Nocturnal Micturitions Per 24 Hours at Weeks 4 and 12|Nocturnal micturitions were defined as those occurring between the time the subject went to bed and the time he or she arose to start the next day. The mean number of nocturnal micturitions per 24 hours was calculated as the total number of nocturnal micturitions divided by the total number of diary days collected at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of nocturnal micturitions relative to baseline=improvement.|Baseline, Week 4 and Week 12|FAS; participants reporting this symptom at baseline (participants with nocturnal >0 micturitions per 24 hours during the 3-day baseline diary period). n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.||Number of episodes||95% Confidence Interval|Mean
782623|NCT00806494|Secondary|Percentage Change From Baseline in the Number of Micturitions Per 24 Hours at Weeks 4 and 12|Percentage change from baseline in micturitions was calculated as change in mean number of micturitions per 24 hours at that visit divided by the baseline mean number of micturitions per 24 hours, multiplied by 100.|Baseline, Week 4 and Week 12|FAS. n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.||Percentage Change||95% Confidence Interval|Mean
782624|NCT00806494|Secondary|Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4|The number of micturitions was measured by the 3-day bladder diary completed for the 3 consecutive days preceding each clinic visit. The mean number of micturitions per 24 hours was calculated as the sum of all micturitions recorded in the diary divided by the number of days the diary was completed at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of micturitions relative to baseline=improvement.|Baseline, Week 4|FAS. N=number of participants with analyzable data.||Number of Episodes||95% Confidence Interval|Mean
782625|NCT00806494|Primary|Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12|The number of micturitions was measured by the 3-day bladder diary completed for the 3 consecutive days preceding each clinic visit. The mean number of micturitions per 24 hours was calculated as the sum of all micturitions recorded in the diary divided by the number of days the diary was completed at that visit. Change=mean at observation minus mean at baseline. Negative change, more specifically (ie), a decrease in number of micturitions relative to baseline=improvement.|Baseline, Week 12|Full analysis set (FAS)=participants who took at least one dose of study drug and provided baseline and post-baseline data for at least 1 efficacy endpoint. N=number of participants with analyzable data. Missing data at Week 12 were imputed using last (valid post-baseline) observation carried forward (LOCF) approach.||Number of Episodes||95% Confidence Interval|Mean
782626|NCT00806546|Primary|Subject Self-examination of Skin Irritation|For each patch application, subjects performed a self-examination of skin irritation using a 5-point scale (0=no redness; 1=minimal skin redness; 2=moderate skin redness with sharp borders; 3=intense skin redness with or without swelling; 4=intense skin redness with blisters or broken skin).|24 hours post patch application|Per protocol, all subjects who applied at least one NP101 study patch were included in the safety population.||scores on a scale|Participants|Standard Deviation|Mean
782627|NCT00806585|Secondary|Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24|HbA1c reported as a % and was measured at baseline and after 24 weeks of study drug administration|Baseline and Week 24|Full Analysis Set (FAS) Population defined as all participants who received at least 1 dose of study drug and did not lack of any endpoint data (both baseline and post-randomization)||Percentage Change||Standard Error|Least Squares Mean
782784|NCT00808080|Secondary|If Phase I Has Successfully Shown the Target Dose to be Below the MTD Continue Enrolling Until 38 Patients Have Received the Target Dose. Patients Will be Monitored for Safety and Efficacy.||2.5 years estimated||||||
782629|NCT00806585|Secondary|Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12|LDL-C calculated by the method of Friedewald equation at baseline and after 12 weeks of study drug administration|Baseline and Week 12|Full Analysis Set (FAS) Population defined as all participants who received at least 1 dose of study drug and had endpoint data (both baseline and post-randomization)||Percentage Change||Standard Error|Least Squares Mean
782630|NCT00806585|Primary|Change From Baseline in Sitting Systolic Blood Pressure (SiSBP) at Week 12|Participant remained in the sitting position for at least 5 minutes before any blood pressure readings were recorded. Systolic and diastolic blood pressures were determined by taking 6 replicate measurements obtained 1 to 2 minutes apart. First reading was discarded and the average the last 5 measurement was recorded.|Baseline and Week 12|Full Analysis Set (FAS) Population defined as all participants who received at least 1 dose of study drug and had endpoint data (both baseline and post-randomization)||mmHg||Standard Error|Least Squares Mean
782631|NCT00806585|Primary|Change From Baseline in Sitting Diastolic Blood Pressure (SiDBP) at Week 12|Participant remained in the sitting position for at least 5 minutes before any blood pressure readings were recorded. Systolic and diastolic blood pressures were determined by taking 6 replicate measurements obtained 1 to 2 minutes apart. First reading was discarded and the average of the last 5 measurement was recorded.|Baseline and Week 12|Full Analysis Set (FAS) Population defined as all participants who received at least 1 dose of study drug and had endpoint data (both baseline and post-randomization)||mmHg||Standard Error|Least Squares Mean
782632|NCT00806598|Primary|Overall Response|Complete response (CR) was defined as normalization of peripheral blood and bone marrow with <5% blasts, a peripheral absolute neutrophil count (ANC) >/= 1 * 10^9/l, hemoglobin >/= 100g/l, and a platelet count >/= * 10^9/l, Partial Response (PR) was defined as transfusion independence with a peripheral blood ANC >=/ 0.05 * 10^9/l, a platelet count >/= 20 * 10^9/l, and a hemoglobin >/= 40 g/l. Hematologic improvement was defined as a clinically relevant increase in hemoglobin, platelets or absolute neutrophil count.|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first. Assessed first at 3 months on study, continuing monthly up to 3 years.|Of the 48 participants who received treatment 46 were evaluable for response.||participants|||Number
782633|NCT00806624|Secondary|Evaluation of All Clinical and Laboratory Safety Data.||6 months||||||
782634|NCT00806624|Secondary|Evaluation of Effects on Pharmacodynamic Biomarkers||6 months||||||
782635|NCT00806624|Secondary|Evaluation of Plasma Concentration of DU-176||6 months||||||
782636|NCT00806624|Secondary|Evaluation of Effects on Biomarkers of Thrombus Formation||6 months||||||
782637|NCT00806624|Secondary|Evaluation of Incidence of Major Adverse Cardiovascular Events: Stroke, Systemic Embolic Event, Myocardial Infarction, Cardiovascular Death, and Hospitalization for Any Cardiac Condition||6 months||||||
782638|NCT00806624|Primary|Incidence of All Bleeding|Incidence of all bleeding (major, clinically relevant non-major and minor) in two fixed dosage of DU-176b in comparison with warfarin as active control in subjects with non-valvular AF.|6 months|The Safety Analysis Set was defined as all subjects who received at least one dose of study drug and had at least one post-dose safety assessment. The primary endpoint were analyzed for the subjects who proceeded to the treatment period in the Safety Analysis Set.||percentage of subjects with bleeds||95% Confidence Interval|Number
782639|NCT00806676|Primary|Percentage of Patients 16-21 Years of Age With a Kidney Transplant Achieving Seropositivity (IgG Assay) at Blood Draw 2||Month 7|||percentage of participants||95% Confidence Interval|Number
782640|NCT00806676|Primary|Percentage of Patients 9-15 Years of Age With a Kidney Transplant Achieving Seropositivity (IgG Assay) at Blood Draw 2||Month 7|Some patients did not complete all 3 blood draws because of (1) previous vaccination at primary care physician’s office, which precluded blood draws 1 and/or 2; (2) inconsistent clinic visits, which precluded the 2nd or 3rd blood draw; and/or (3) administrative censoring in July 2012.||percentage of participants||95% Confidence Interval|Number
782641|NCT00806676|Primary|Percentage of Patients 16-21 Years of Age on Dialysis Achieving Seropositivity (IgG Assay) at Blood Draw 2||Month 7|Some patients did not complete all 3 blood draws because of (1) previous vaccination at primary care physician’s office, which precluded blood draws 1 and/or 2; (2) inconsistent clinic visits, which precluded the 2nd or 3rd blood draw; and/or (3) administrative censoring in July 2012.||percentage of participants||95% Confidence Interval|Number
782642|NCT00806676|Primary|Percentage of Patients 9-15 Years of Age on Dialysis Achieving Seropositivity (IgG Assay) at Blood Draw 2||Month 7|Some patients did not complete all 3 blood draws because of (1) previous vaccination at primary care physician’s office, which precluded blood draws 1 and/or 2; (2) inconsistent clinic visits, which precluded the 2nd or 3rd blood draw; and/or (3) administrative censoring in July 2012.||percentage of participants||95% Confidence Interval|Number
782643|NCT00806676|Primary|Percentage of Patients 16-21 Years of Age With CKD Achieving Seropositivity (IgG Assay) at Blood Draw 2||Month 7|Some patients did not complete all 3 blood draws because of (1) previous vaccination at primary care physician’s office, which precluded blood draws 1 and/or 2; (2) inconsistent clinic visits, which precluded the 2nd or 3rd blood draw; and/or (3) administrative censoring in July 2012.||percentage of participants||95% Confidence Interval|Number
782644|NCT00806676|Primary|Percentage of Patients 9-15 Years of Age With CKD Achieving Seropositivity (IgG Assay) at Blood Draw 2|The primary outcome was antibody response to each of four HPV genotypes contained within the HPV vaccine at the time periods specified for the blood draws. Antibody levels, measured by Merck GmbH, were initially determined using the competitive Luminex immunoassay(cLIA; Merck GmbH), the assay used in the original licensing studies. Seropositivity was defined as being above thresholds set at 20, 16, 20, and 24 milliMerck units for HPV genotypes 6, 11, 16, and 18, respectively, as determined in phase 2 studies among patients who were immunocompetent. Antibody levels were reanalyzed using the newer, more sensitive IgG cLIA in stored serum from blood draws 2 and 3. Seropositivity for this assay was defined as being above thresholds set at 15, 15, 7, and 10 milliMerck units for HPV genotypes 6, 11, 16, and 18, respectively.|Month 7|Some patients did not complete all 3 blood draws because of (1) previous vaccination at primary care physician’s office, which precluded blood draws 1 and/or 2; (2) inconsistent clinic visits, which precluded the 2nd or 3rd blood draw; and/or (3) administrative censoring in July 2012.||percentage of participants||95% Confidence Interval|Number
785025|NCT00834626|Secondary|Percentage of Participants Not Requiring Insulin|After this Metabolic surgery, usually no Insulin is required by patient after 1 month, and definitely not after 3 months|1 year|||Percentage of Participants|||Number
782645|NCT00806819|Secondary|Incidence and Intensity of Adverse Events|"Incidence and intensity of adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The worst CTCAE grade per patient is reported and MedDRA version 15.1 used.
Serious signs and symptoms of progressive disease were reported as an adverse event in analysis of this endpoint."|From the first drug administration until 28 days after the last drug administration, up to 36 months|Treated set uncut - all randomised patients who were documented to have taken at least 1 dose of study medication . Patients were allocated to the treatment groups according to the treatment actually received.||% of participants|||Number
782646|NCT00806819|Secondary|Dose Normalised Predose Plasma Concentration at Steady State (Cpre,ss,Norm) of Nintedanib and of Its Metabolites BIBF 1202 and BIBF 1202 Glucuronide|Geometric mean of dose normalised predose plasma concentration (Cpre,ss,norm) of nintedanib and of its metabolites BIBF 1202 and BIBF 1202 glucuronide evaluated at steady state based on course 2 and 3. If only one value was available and valid, then this value was used for calculation of Cpre,ss,norm.|Before the administration of nintedanib or placebo and between a window of 30 mins to an hour after administration of trial drug during Course 2 and between 1 and 3 hours after administration of trial drug during Course 3|Pharmacokinetic set- all patients in the treated set who were documented to have received at least 1 dose of nintedanib and who had at least 1 valid drug plasma concentration available||ng/mL/mg||Geometric Coefficient of Variation|Geometric Mean
782647|NCT00806819|Secondary|Quality of Life (QoL)|"QoL was measured by standardised questionnaires (EQ-5D, EORTC QLQ-C30, EORTC QLQ-LC13). The EORTC QLQ-C30 comprises of 30 questions, using both multi-item scales and single-item measures. EORTC LC-13 comprises of 13 questions incorporating 1 multi-item scale and a series of single items. The following were the main points of interest: Time to deterioration of cough (QLQ-LC13 question 1), Time to deterioration of dyspnoea (QLQ-LC13, composite of questions 3 to 5), Time to deterioration of pain (QLQ- C30, composite of questions 9 and 19). Time to deterioration of cough, dyspnoea and pain was defined as the time to a 10-point increase from the baseline score.
Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve."|From randomisation until data cut-off (15 February 2013), Up to 30 months|RS||Months||Inter-Quartile Range|Median
782648|NCT00806819|Secondary|Clinical Improvement.|"Clinical improvement was defined as the time from randomisation to deterioration in body weight and/or Eastern Cooperative Oncology group performance score (ECOG PS) whichever occurred first.
Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve."|From randomisation until data cut-off (15 February 2013), Up to 30 months|RS||Months||Inter-Quartile Range|Median
782649|NCT00806819|Secondary|Change From Baseline in Tumour Size|Percentage change from baseline in tumour size is defined as decrease in the sum of the longest diameter of the target lesion. Presented means are in fact adjusted best means percentage changes generated from ANOVA model adjusted for baseline ECOG PS (0 vs. 1), tumour histology (adenocarcinoma vs. non-adenocarcinoma), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no) This endpoint was analysed based on the central independent reviewer as well as the investigator.|From randomisation until data cut-off (15 February 2013), Up to 30 months|RS||percentage of change in tumor size in mm||95% Confidence Interval|Mean
782650|NCT00806819|Secondary|Duration of Disease Control|"The duration of disease control was defined as the time from randomisation to the date of disease progression or death (which ever occurs first) for patients with disease control. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.
This endpoint was analysed based on the central independent reviewer as well as the investigator."|From randomisation until data cut-off (15 February 2013), Up to 30 months|RS||Months||Inter-Quartile Range|Median
782651|NCT00806819|Secondary|Disease Control|"Disease control was defined as a best overall response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) and evaluated according to the modified RECIST criteria version 1.0.
This endpoint was analysed based on the central independent reviewer as well as the investigator."|From randomisation until data cut-off (15 February 2013), Up to 30 months|RS||% of participants|||Number
782652|NCT00806819|Secondary|Time to Confirmed Objective Tumour Response|"Time to confirmed objective response is defined as time from randomisation to the date of first documented (CR) or (PR) and evaluated according to the modified RECIST criteria version 1.0. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.
This endpoint was analysed based on the central independent reviewer as well as the investigator."|From randomisation until data cut-off (15 February 2013), Up to 30 months|RS||Months||Inter-Quartile Range|Median
782653|NCT00806819|Secondary|Duration of Confirmed Objective Tumour Response|"The duration of objective response is the time from first documented (CR) or (PR) to the time of progression or death and evaluated according to the modified RECIST criteria version 1.0. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.
This endpoint was analysed based on the central independent reviewer as well as the investigator."|From randomisation until data cut-off (15 February 2013), Up to 30 months|RS||Months||Inter-Quartile Range|Median
782654|NCT00806819|Secondary|Objective Tumor Response|Confirmed objective response is defined as confirmed Complete Response (CR) and Partial Response (PR) and evaluated according to the modified RECIST criteria version 1.0. This endpoint was analysed based on the central independent reviewer as well as the investigator|From randomisation until data cut-off (15 February 2013), Up to 30 months|Randomised Set||% of participants|||Number
782655|NCT00806819|Secondary|Follow-up Analysis of Progression Free Survival (PFS) as Assessed by Investigator|Follow-up analysis was conducted at the time of overall survival analysis. Progression Free Survival (PFS) as assessed by investigator according to the modified RECIST (version 1.0) criteria. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.|From randomisation until data cut-off (15 February 2013), Up to 30 months|RS||Months||Inter-Quartile Range|Median
782656|NCT00806819|Secondary|Follow-up Analysis of Progression Free Survival (PFS) as Assessed by Central Independent Review|Follow-up analysis was conducted at the time of overall survival analysis. Progression Free Survival (PFS) as assessed by central independent review according to the modified RECIST (version 1.0) criteria. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.|From randomisation until data cut-off (15 February 2013), Up to 30 months|RS||Months||Inter-Quartile Range|Median
782785|NCT00808080|Primary|6 Dose Cohorts for Safety Monitoring. Each Cohort is Assessed for DLT for One Month After Autologous Cultured CTL Infusion Prior to Enrolling the Next Cohort.||2.5 years estimated|Not Applicable as none of the enrolled patients became eligible for infusion|||||
782658|NCT00806819|Primary|Progression Free Survival (PFS) as Assessed by Central Independent Review|"Progression Free Survival (PFS) as assessed by central independent review according to the modified RECIST (version 1.0) criteria. Progression free survival (PFS) is defined as the duration of time from date of randomisation to date of progression or death (whatever occurs earlier).
Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve."|From randomisation until cut-off date 9 July 2012|RS||months||Inter-Quartile Range|Median
782659|NCT00806988|Secondary|Major Adverse Cardiac Event, Including Death, Stroke, Worsening Heart Failure (+1 New York Heart Association [NYHA] Class), Congestive Heart Failure Hospitalization, or Mitral Valve Re-intervention||Measured at Month 24|||Participants|||Count of Participants
782660|NCT00806988|Primary|Degree of Left Ventricular Remodeling, as Assessed by Left Ventricular End Systolic Volume Index (LVESVI)||Measured at Month 12|||ml per square meter||Standard Deviation|Mean
782661|NCT00807001|Secondary|Antiviral Activity at Day 4. Change in Plasma HCV RNA (Hepatitis C Virus Ribonucleic Acid)|Measures how much virus is in the blood.|Baseline to 4 days|efficacy evaluable population = a) must have received all 3 doses of study drug b) must have baseline and at least one post-baseline HCV RNA determination||log10 IU/mL||Standard Deviation|Mean
782662|NCT00807001|Primary|Number of Subjects With Any Adverse Event (Side Effect) and the Severity of Those Adverse Events|Monitoring of adverse events, physical examination, routine safety laboratory parameters and electrocardiograms. 1=mild, 2=moderate, 3=severe, 4=potentially life-threatening|17 days|Safety population consisted of all subjects who received at least one dose of study drug.||participants|||Number
782663|NCT00807014|Secondary|Number of Participants in the Indicated Categories for Overall Tolerance at Week 12/Early Termination|Participants were evaluated for overall tolerance to study drug by the investigator at the end of the study (Week 12 or Early Termination). Participants were given the tolerance grades of poor, fair, good, or excellent.|Week 12 or Early Termination|ITT Population. Some participants had no data available and were thus excluded from analysis.||participants|||Number
782664|NCT00807014|Secondary|Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Itching and Burning|Tolerance symptoms of itching and burning were evaluated at each visit by participants. Possible scores were: 0=absent, 1=mild intermittent, 2=mild persistent, 3=moderate intermittent, 4=moderate persistent, 5=severe intermittent, and 6=severe persistent.|Baseline (Week 0); Weeks 1, 2, 4, 8, and 12|ITT Population. Missing values were imputed using the LOCF method (i.e., the last available observation was used to estimate subsequent missing data points).||scores on a scale||Standard Deviation|Mean
782665|NCT00807014|Secondary|Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Peeling, Erythema, and Dryness|Tolerance symptoms of peeling (flaking), erythema (redness of skin), and dryness were evaluated at each visit by the investigator. Possible scores were: 0=absent, 1=mild intermittent, 2=mild persistent, 3=moderate intermittent, 4=moderate persistent, 5=severe intermittent, and 6=severe persistent.|Baseline (Week 0); Weeks 1, 2, 4, 8, and 12|ITT Population. Missing values were imputed using the LOCF method (i.e., the last available observation was used to estimate subsequent missing data points).||scores on a scale||Standard Deviation|Mean
782666|NCT00807014|Secondary|Mean Acne Grades at Baseline and Weeks 1, 2, 4, 8, and 12 Assessed by the Leeds Revised Acne Grading System|The acne grade on the participant’s face was assessed by the investigator using the LRAG, a photographic scale allowing for the assessment of the clinical status for acne severity for the face, back, and chest. It consists of a 12-grade scale (1, least severe; 12, most severe) for inflammatory visible lesions (les.). For non-inflammatory les., this scale comprises 3 photos of les. of increasing severity (grades 1-3). The scale provides a qualitative assessment of superficial/visible les. and provides consistency and inter-/intra-rater reliability. Grading was performed prior to les. counting.|Baseline (Week 0); Weeks 1, 2, 4, 8, and 12|ITT Population. Missing values were imputed using the LOCF method.||scores on a scale||Standard Deviation|Mean
782667|NCT00807014|Secondary|Mean Scores for Self-evaluation of Acne Improvement at Weeks 1, 2, 4, 8, and 12 Compared to the Start of Treatment (Prior to Week 1)|Participants self-evaluated their acne improvement on a 3-point scale: 1=worsened, 2=no changes, and 3=improved.|Start of treatment and Weeks 1, 2, 4, 8, and 12|ITT Population. Missing values were imputed using the LOCF method. Only those participants contributing data at the indicated time points were analyzed.||scores on a scale||Standard Deviation|Mean
782668|NCT00807014|Secondary|Mean Scores for Global Change in Acne Improvement at Weeks 1, 2, 4, 8, and 12 Compared to the Start of Treatment (Prior to Week 1)|Global change in acne improvement was assessed by the investigator on a 7-point scale: 1=greatly worsened, 2=significantly worsened, 3=slightly worsened, 4=no change, 5=slightly improved, 6=significantly improved, or 7=greatly improved. Global change at the indicated week was assessed in terms of change from the previous week. Change at Week 2, for example, was an assessment of change from Week 1.|Start of treatment and Weeks 1, 2, 4, 8, and 12|ITT Population. Missing values were imputed using the LOCF method. Only those participants contributing data at the indicated time points were analyzed.||scores on a scale||Standard Deviation|Mean
782669|NCT00807014|Secondary|Correlation Between Skindex-29 Questionnaire Scores and Total Lesion Counts From Baseline to Week 2|Analyses were performed to determine whether there was a correlation between the total lesion count and either the global or subdomain Skindex-29 questionnaire scores. Correlations between the Skindex-29 questionnaire scores and total lesion count from Baseline to Week 2 were assessed using Spearman’s correlation coefficients, which ranges from -1 to 1. A score of 0 denotes no correlation, a score approaching 1 denotes correlation, and a score approaching -1 denotes inverse correlation.|Baseline (Week 0) and Week 2|ITT Population. Missing values were imputed using the LOCF method. One participant in the Differin group had no data available and was thus excluded from analysis.||Correlation coefficient|||Number
782680|NCT00807092|Secondary|Change in MAGE (Mean Amplitude of Glycaemic Excursions) Assessed by CGMS|MAGE is a parameter to monitor the intraday blood glucose excursions. It was calculated using CGMS data and as the arithmetic mean of glycaemic excursion with the criterion that both segments (ascending and descending parts) of the glycaemic excursion exceed of the value of one standard deviation of respective 24-hour blood glucose value. The direction of calculation (peak-to-nadir or nadir-to-peak) was established by the direction of the first excursion. The arithmetic mean of the glycaemic excursion of day 1 and day 2 was the value of MAGE for each CGMS|Week 0, Week 6|The full analysis set using LOCF (Last Observation Carried Forward) consists of all randomised subjects who had been exposed to at least one dose of the trial products.||mmol/L||Standard Error|Least Squares Mean
782670|NCT00807014|Secondary|Mean Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory, Non-inflammatory, and Total Lesion Counts|Lesions were counted on the entire face (defined as the area from the upper part of the jaw to the lower part of the hairline), excluding maculae and non-inflammatory lesions located on the nose or chin. Inflammatory lesions (IL) included papules, pustules, nodules, and cysts. Non-inflammatory lesions (NIL) included closed comedones (whiteheads) and open comedones (blackheads). Total lesion count was calculated as the sum of IL and NIL. Percent change from Baseline was calculated as the values at Weeks 1, 2, 4, 8, and 12 minus the value at Baseline divided by Baseline value * 100.|Baseline (Week 0) and Weeks 1, 2, 4, 8, and 12|ITT Population. Missing values were imputed using the LOCF method. Some participants had no baseline lesions of an individual type; percent change from baseline is undefined for these participants. All participants, however, had at least one type of lesion; thus, all participants in the ITT Population were analyzed for total lesion count.||percent change in lesions||Standard Deviation|Mean
782671|NCT00807014|Secondary|Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory, Non-inflammatory, and Total Lesion Counts|Lesions were counted on the entire face (defined as the area from the upper part of the jaw to the lower part of the hairline), excluding maculae and non-inflammatory lesions located on the nose or chin. Inflammatory lesions included papules, pustules, nodules, and cysts. Non-inflammatory lesions included closed comedones (whiteheads) and open comedones (blackheads). The total lesion count was calculated as the sum of inflammatory and non-inflammatory lesions. Change from Baseline was calculated as the values at Weeks 1, 2, 4, 8, and 12 minus the value at Baseline (Week 0).|Baseline (Week 0) and Weeks 1, 2, 4, 8, and 12|ITT Population. Missing values were imputed using the LOCF method.||lesions||Standard Deviation|Mean
782672|NCT00807014|Secondary|Mean Change From Baseline to Week 12 for the Indicated Domain Scores and the Global Score of the Participant-completed Skindex-29 QoL Questionnaire|Skindex-29 is a self-administered QoL questionnaire comprised of 29 items scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 items), symptomatic (7 items), and functional (12 items), with domain scores ranging from 0 to 40, 28, and 48, respectively. Lower scores = better QoL. A Global Score (range 0-100) was derived by multiplying the sum of the points for all 29 items by a constant (0.862). Change from Baseline was calculated as the value at Week 2 minus the value at Baseline (Week 0).|Baseline (Week 0) and Week 12|ITT Population. Missing values were imputed using the LOCF method (i.e., the last available observation was used to estimate subsequent missing data points). One participant in the Differin arm had no QoL data available and was thus excluded from analysis.||scores on a scale||Standard Deviation|Mean
782673|NCT00807014|Primary|Mean Change From Baseline to Week 2 in the Global Score of the Participant-completed Skindex-29 Quality of Life (QoL) Questionnaire|Skindex-29 is a self-administered QoL questionnaire comprised of 29 items scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 items), symptomatic (7 items), and functional (12 items), with domain scores ranging from 0 to 40, 28, and 48, respectively. Lower scores = better QoL. A Global Score (range 0-100) was derived by multiplying the sum of the points for all 29 items by a constant (0.862). Change from Baseline was calculated as the value at Week 2 minus the value at Baseline (Week 0).|Baseline (Week 0) and Week 2|Intent-to-Treat (ITT) Population: all randomized participants (par.) who applied >= 1 dose of study product. Missing values were imputed using the last observation carried forward (LOCF, i.e., the last available observation was used to estimate subsequent missing data points) method. 1 par. in the Differin arm had no QoL data and was not analyzed.||scores on a scale||Standard Deviation|Mean
782674|NCT00807040|Secondary|All-cause Mortality||Measured at Month 24|||Participants|||Count of Participants
782675|NCT00807040|Primary|Degree of Left Ventricular Remodeling, as Assessed by Left Ventricular End Systolic Volume Index (LVESVI)||Measured at Month 12|||ml per square meter of body-surface area||Standard Deviation|Mean
782676|NCT00807092|Secondary|Hypoglycaemia Based on Self-reported Episodes|Total number of hypoglycaemic episodes occurring in the trial after baseline (week 0) until the end of treatment (week 6). Hypoglycaemic episodes are classified as major, minor or symptoms only: Major if the subject was unable to treat her/himself; minor if subject was able to treat her/himself and self monitored blood glucose (SMBG) was below 2.8 mmol/L; symptoms only if subject was able to treat her/himself and with no blood glucose measurement or SMBG higher than or equal to 2.8 mmol/L.|Weeks 0-6|Safety analysis set consists of all randomised subjects who were exposed to at least one dose of trial product(s).||episodes|||Number
782677|NCT00807092|Secondary|Duration of Hypoglycaemic Events Based on CGMS|The CGMS device recorded blood glucose levels every 10 seconds then stored a smoothed average over 5 minutes. The range of blood glucose detection was 2.2-22 mmol/l. Hypoglycaemia was defined as blood glucose readings below 3.5 mmol/l or below 2.5 mmol/l, respectively. The duration of the hypoglycaemic episodes was quantified by accumulating the total time the CGMS profiles stays below the defined threshold (i.e. below 3.5 mmol/l or below 2.5 mmol/l, respectively).|72-hour monitoring period at Week 0 and Week 6|Safety analysis set consists of all randomised subjects who were exposed to at least one dose of trial product(s).||Hours||Standard Error|Least Squares Mean
782678|NCT00807092|Secondary|Change in Glycosylated Haemoglobin (HbA1c)||Week -2, week 6|The full analysis set using LOCF (Last Observation Carried Forward) (if a measurement on the withdrawal visit was available) consists of all randomised subjects who had been exposed to at least one dose of the trial products.||percentage point change||Standard Error|Least Squares Mean
782679|NCT00807092|Secondary|Change in GA (Glycated Albumin)|Glycated Albumin is used as a general glycaemic control parameter. Analysed by laboratory. GA was measured at baseline (week 0) and end of treatment (week 6). Change in GA at end of treatment (week 6) from baseline (week 0) was assessed.|Week -2, week 6|The full analysis set using LOCF (Last Observation Carried Forward) (if a measurement on the withdrawal visit was available) consists of all randomised subjects who had been exposed to at least one dose of the trial products.||percentage point change||Standard Error|Least Squares Mean
782681|NCT00807092|Secondary|Change in Prandial Blood Glucose Increment|Subjects were asked to perform 8-point SMBG profiles using the provided blood glucose meter on one day within 72 hours CGMS monitoring period at week 0 and week 6 respectively. Prandial increment was the difference between the blood glucose (BG) value measured 120 minutes after meal and the BG value measured before meal.|Week 0, Week 6|The full analysis set using LOCF (Last Observation Carried Forward) consists of all randomised subjects who had been exposed to at least one dose of the trial products.||mmol/L||Standard Error|Least Squares Mean
782682|NCT00807092|Secondary|Change in 8-point SMBG (Self-monitored Blood Glucose) Profiles|Subjects were asked to perform 8-point SMBG profiles using the provided blood glucose meter on one day within 72 hours CGMS monitoring period at week 0 and week 6. Change in blood glucose level at end of treatment (week 6) from baseline (week 0) at each time point was to be assessed respectively. Blood glucose levels were measured at the following 8 time points: Before each meal (breakfast, lunch and dinner), 120 minutes after the start of each meal, at bedtime and at 3 am in the morning.|Week 0, Week 6|The full analysis set using LOCF (Last Observation Carried Forward) consists of all randomised subjects who had been exposed to at least one dose of the trial products||mmol/L||Standard Error|Least Squares Mean
782683|NCT00807092|Secondary|Change in FPG (Fasting Plasma Glucose)|FPG was analysed by local laboratories at baseline (week 0) and end of treatment (week 6). Change in FPG at end of treatment (week 6) from baseline (week 0) was to be assessed.|Week 0, Week 6|The full analysis set using LOCF (Last Observation Carried Forward) (if a measurement on the withdrawal visit was available) consists of all randomised subjects who had been exposed to at least one dose of the trial products.||mmol/L||Standard Error|Least Squares Mean
782684|NCT00807092|Secondary|Change in Mean FBG Assessed by CGMS|The blood glucose profiles were monitored by CGMS for 72 hours at baseline (week 0) and at end of treatment (week 6). Change in mean FBG from baseline (week 0) was assessed. FBG was read on the CGMS glucose curves at 06:00 each morning over the 72 hours. The arithmetic mean of day 1 and day 2 was used as the value of mean FBG for each CGMS period.|Week 0, week 6|||mmol/L||Standard Error|Least Squares Mean
782685|NCT00807092|Secondary|Mean FBG (Fasting Blood Glucose) Assessed by CGMS|The blood glucose profiles were monitored by CGMS for 72 hours at end of treatment (week 6). Mean FBG assessed by CGMS at 6 weeks. FBG was read on the CGMS glucose curves at 06:00 each morning over the 72 hours. The arithmetic mean of day 1 and day 2 was used as the value of mean FBG for each CGMS period.|Week 6|The full analysis set using LOCF (Last Observation Carried Forward) consists of all randomised subjects who had been exposed to at least one dose of the trial products.||mmol/L||Standard Error|Least Squares Mean
782686|NCT00807092|Secondary|Change in Mean IAUC for Postprandial Glucose (0-4 Hours) After Each Meal (Breakfast, Lunch, Dinner) Assessed by CGMS|The blood glucose profiles were monitored by CGMS for 72 hours at baseline (week 0) and end of treatment (week 6). IAUC (0-4 hours) after each meal at 6 weeks and change in IAUC (0-4 hours) from baseline (week 0) after each meal were to be assessed. The arithmetic mean of day 1 and day 2 for each meal-specific incremental area (breakfast, lunch, dinner) was calculated.|Week 0, Week 6|The full analysis set using LOCF (Last Observation Carried Forward) consists of all randomised subjects who had been exposed to at least one dose of the trial products.||mmol/L||Standard Error|Least Squares Mean
782687|NCT00807092|Primary|Change in IAUC (Incremental Area Under the Curve) for Postprandial Glucose (0-4 Hours) Over 3 Main Meals|The blood glucose profiles were monitored by CGMS (Continuous Glucose Monitoring System) for 72 hours at baseline (week 0) and end of treatment (week 6). IAUC was calculated using the trapezoidal method. The arithmetic mean of IAUC (3 meal-specific incremental areas) of day 1 and day 2 was used as the value of IAUC for each CGMS period|Week 0, week 6|The full analysis set using LOCF (Last Observation Carried Forward) consists of all randomised subjects who had been exposed to at least one dose of the trial products.||mmol/L||Standard Error|Least Squares Mean
782688|NCT00807209|Primary|Amount of Rescue PCA Fentanyl Administered for Breakthrough Pain During the First 72 Hours.|The primary outcome metric was to be the amount of rescue epidural fentanyl administered for breakthrough pain during the first 72 hours postoperatively. Patient-controlled analgesia (PCA) fentanyl intake was to be summarized for each treatment group as time to first use of rescue PCA fentanyl, amount of PCA fentanyl administered over 72 hours, and total amount of PCA fentanyl administered through a number of time intervals. However, efficacy analyses were not performed because the study was terminated early after only three subjects were enrolled.|72 hours|||micrograms|||Number
782689|NCT00807235|Secondary|Number of Participants With Air Leak||28 days|"This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed.
All enrolled infants analyzed (intent-to-treat)."||participants|||Number
782690|NCT00807235|Secondary|Incidence of Mortality||28 days|"This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed.
All enrolled infants analyzed (intent-to-treat)."||participants|||Number
782691|NCT00807235|Secondary|Number of Participants With Acquired Sepsis||28 days|"This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed.
All enrolled infants analyzed (intent-to-treat)."||participants|||Number
782692|NCT00807235|Secondary|Number of Participants With Pulmonary Hemorrhage||28 days|"This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed.
All enrolled infants analyzed (intent-to-treat)."||participants|||Number
782693|NCT00807235|Secondary|Number of Participants With Necrotizing Enterocolitis (NEC)||28 days|"This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed.
All enrolled infants analyzed (intent-to-treat)."||participants|||Number
782694|NCT00807235|Secondary|Number of Participants With Patent Ductus Arteriosus (PDA)||28 days|"This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed.
All enrolled infants analyzed (intent-to-treat)."||participants|||Number
782695|NCT00807235|Secondary|Number of Participants With Intraventricular Hemorrhage (IVH)/Periventricular Leukomalacia (PVL)||28 days|"This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed.
All enrolled infants analyzed (intent-to-treat)."||participants|||Number
782696|NCT00807235|Secondary|Number of Participants Alive and Without BPD||28 days|"This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed.
All enrolled infants analyzed (intent-to-treat)."||participants|||Number
782697|NCT00807235|Secondary|Number of Participants With Bronchopulmonary Dysplasia (BPD)||28 days|"This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed.
All enrolled infants analyzed (intent-to-treat)."||participants|||Number
782698|NCT00807235|Secondary|Time to Meet Failure Criteria|Failure criteria defined as rescue with bolus surfactant and mechanical ventilation|Through 28 days|"This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed.
All enrolled infants analyzed (intent-to-treat). Time in days calculated for neonates who met failure criteria (3 for Regimen 1, 2 for Regimen 2)"||days||Standard Deviation|Mean
782715|NCT00807560|Secondary|BMI Percentile|Body Mass Index percentile. This is not a primary outcome variable.|baseline|||percentile||Standard Deviation|Mean
782699|NCT00807235|Secondary|Arterial Alveolar (a/A) O₂Ratio|a/A ratio is a relative way to judge the lungs ability to transport O₂. It compares the partial pressure of O₂in the alveoli (A) to the partial pressure of O₂in the artery (a). It is calculated by dividing the partial pressure of O₂in the artery, abbreviated PaO2, by the partial pressure of O₂in the alveoli using the alveolar gas equation, abbreviated PAO2. A value of 0.80 or above is normal, a value of 0.60 or below may be incompatible with spontaneous breathing, and a value below 0.22 indicates severe lung disease.|72 hours|"This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed.
All enrolled infants analyzed (intent-to-treat)."||mm Hg over mm Hg (ratio of pressures)||Standard Deviation|Mean
782700|NCT00807235|Secondary|Area Under the Curve (AUC) for Fraction of Inspired Oxygen (FiO₂)|AUC for FiO₂calculated using the trapezoidal rule. Missing data imputed using last observation carried forward|0.5, 1, 2, 4, 6, 12, 18, 24, 36, 48, 60, 72 hours|"This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed.
All enrolled infants analyzed (intent-to-treat)."||percent O₂*hours||Standard Deviation|Mean
782701|NCT00807235|Primary|Number of Participants With Respiratory Distress Syndrome||24 hours|"This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed.
All enrolled infants analyzed (intent-to-treat)."||participants|||Number
782702|NCT00807248|Secondary|Clinical Global Impression - Global Improvement (CGI-I)|The CGI-I provides the clinician’s impression of the patient’s improvement (or worsening). The clinician assesses the patient’s condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).|at Week 8|At Week 8 (FAS, LOCF, ANCOVA)||Scores on a scale||Standard Error|Mean
782703|NCT00807248|Secondary|Clinical Global Impression - Severity of Illness (CGI-S)|The CGI-S provides the clinician’s impression of the patient’s current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient’s current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients).|Mean change from baseline to Week 8|Mean change from baseline to Week 8 (FAS, LOCF, ANCOVA)||Scores on a scale||Standard Error|Mean
782704|NCT00807248|Secondary|SDS: Social Subscale|The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment.|Mean change from baseline to Week 8|Mean change from baseline to Week 8 (FAS, LOCF, ANCOVA)||Scores on a scale||Standard Error|Mean
782705|NCT00807248|Secondary|SDS: Work Subscale|The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment.|Mean change from baseline to Week 8|Mean change from baseline to Week 8 (FAS, LOCF, ANCOVA)||Scores on a scale||Standard Error|Mean
782706|NCT00807248|Secondary|Sheehan Disability Scale (SDS): Family Subscale|The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment.|Mean change from baseline to Week 8|Mean change from baseline to Week 8 (FAS, LOCF, ANCOVA)||Scores on a scale||Standard Error|Mean
782707|NCT00807248|Secondary|Insomnia Severity Index (ISI)|The ISI is both a brief screening measure of insomnia and an outcomes measure for use in treatment research. It is a brief self-report instrument measuring the patient’s perception of his or her insomnia, and it comprises 7 items. Each item is rated on a 0-4 scale and the total score ranges from 0 to 28. 0 = no symptoms and 28 = severe symptoms.|Mean change from baseline to Week 8|Mean change from baseline to Week 8 (FAS, LOCF, ANCOVA)||Scores on a scale||Standard Error|Mean
782708|NCT00807248|Secondary|Hospital Anxiety and Depression Scale (HADS)|The HADS is a patient-rated scale designed to screen for anxiety and depressive states in medical patients. It consists of two sub-scales: the D-scale measures depression and the A-scale measures anxiety. Each sub-scale contains 7 items, and each item is rated from 0 (absent) to 3 (maximum severity). The score of each sub-scale ranges from 0 to 21, and are analysed separately. The total HADS score ranges from 0 to 42.|Mean change from baseline to Week 8|Mean change from baseline to Week 8 (FAS, LOCF, ANCOVA)||Scores on a scale||Standard Error|Mean
782709|NCT00807248|Secondary|MADRS|The MADRS is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at 2-point intervals. The total score of the 10 items ranges from 0 to 60.|From baseline to Week 8|Mean change from baseline to Week 8 (FAS, LOCF, ANCOVA)||Scores on a scale||Standard Error|Least Squares Mean
782710|NCT00807248|Primary|Montgomery and Åsberg Depression Rating Scale (MADRS)|The MADRS is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at 2-point intervals. The total score of the 10 items ranges from 0 to 60.|Baseline to 8 weeks|Mean change from baseline to Week 8: Full-analysis Set (FAS), Last Observation Carried Forward (LOCF), Analysis of Covariance (ANCOVA)||Scores on a scale||Standard Error|Mean
782711|NCT00807365|Primary|Change in Lean Body Mas||2 years|Study terminated prior to collection of data|||||
782712|NCT00807456|Primary|Bone Level Changes at the Lingual Aspect From Implant Placement (Baseline) to 16 Weeks After Implant Placement|Clinical measurements after implant installation and after 16 weeks to determine bone levels at the buccal and lingual aspects in relation to a fixed landmark on the implant (the rim (R), i.e. the interface between the micro-threaded part and the shoulder at the marginal portion of the implants.The assessments were made using a periodontal probe and distances were measured to the nearest 0.5 mm. Negative value denotes loss of bone.|At baseline and 16 weeks|||millimeter|Participants|Standard Deviation|Mean
782713|NCT00807560|Secondary|BMI Percentile|Body Mass Index percentile. This is not a primary outcome variable.|up to 44 weeks|||percentile||Standard Deviation|Mean
782714|NCT00807560|Primary|BMI Z Score|Z-score was calculated using the Baylor College of Medicine Children's Nutrition Research Center's online BMI calculator (https://www.bcm.edu/research/centers/childrens-nutrition-research-center/bodycomp/bmiz2.html)|up to 44 weeks|||Z-score||Standard Deviation|Mean
782728|NCT00807573|Primary|Objective Response Rate (CR + PR by RECIST) Paclitaxel, Pemetrexed, and Bevacizumab in Patients With Advanced Non-Small Lung Cancer Who Have Received no Prior Treatment for Metastatic Disease.|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|2 years|||participants|||Number
782729|NCT00807846|Other Pre-specified|Change From Baseline in Assessment of ABPM for Heart Rate at Week 6/Final Visit (Sensitivity Analysis Excluding One Participant)|A summary of ABPM 24-hour averages for heart rate is presented in this Outcome Measure. One of the participant in the Naproxen ABPM Arm had clinically implausible high BP values at Baseline. Due to the low number of participants in each Arm (12 and 11) these values had a significant impact on the mean baseline values for the Naproxen Arm. As a result, an additional sensitivity analysis was conducted, excluding this participant (Participant ID 10031002).|6 weeks/Final Visit|Safety population included all randomized participants who received at least one dose of study medication. A total of 22 out of 24 participants were analyzed in this sensitivity analysis. Two participants were excluded, one due to outlying BP values at Baseline and another due to the device failure to collect 11 out of 24 readings).||bpm||Standard Deviation|Mean
782730|NCT00807846|Other Pre-specified|Change From Baseline in Assessment of ABPM for SBP and DBP Pressure at Week 6/Final Visit (Sensitivity Analysis Excluding One Participant)|A summary of ABPM 24-hour averages for SBP and DBP are presented in this Outcome Measure. One of the participant in the Naproxen ABPM Arm had clinically implausible high BP values at Baseline. Due to the low number of participants in each Arm (12 and 11) these values had a significant impact on the mean baseline values for the Naproxen Arm. As a result, an additional sensitivity analysis was conducted, excluding this participant (Participant ID 10031002).|6 weeks/Final Visit|Safety population included all randomized participants who received at least one dose of study medication. A total of 22 out of 24 participants were analyzed in this sensitivity analysis. Two participants were excluded, one due to outlying BP values at Baseline and another due to the device failure to collect 11 out of 24 readings).||mmHg||Standard Deviation|Mean
782731|NCT00807846|Other Pre-specified|Change From Baseline in Assessment of ABPM for Heart Rate at Week 6/Final Visit|Ambulatory BP measurements were obtained from 24 participants (in addition to the BP measurements obtained by the cuff technique) participating in the exploratory 24-hour ABPM sub-study. A summary of ABPM 24-hour averages for heart rate is presented in this Outcome Measure.|6 weeks/Final Visit|Safety population included all randomized participants who received at least one dose of study medication. For one participant in Naproxen Arm the device failed to collect 11 out of 24 readings at Week 6 and this participant was not included in analysis. ABPM data were analyzed for 12 and 11 participants in Celecoxib and Naproxen Arms respectively.||bpm (beats per minute)||Standard Deviation|Mean
782732|NCT00807846|Other Pre-specified|Change From Baseline in Assessment of Ambulatory Blood Pressure Monitoring (ABPM) for SBP and DBP at Week 6/Final Visit|Ambulatory BP measurements were obtained from 24 participants(in addition to the BP measurements obtained by the cuff technique) participating in the exploratory 24-hour ABPM sub-study. BP was monitored by a 24 hour Ambulatory BP device provided by a central vendor.|6 weeks/Final Visit|Safety population included all randomized participants who received at least one dose of study medication. For one participant in Naproxen Arm the device failed to collect 11 out of 24 readings at Week 6 and this participant was not included in analysis. ABPM data were analyzed for 12 and 11 participants in Celecoxib and Naproxen Arms respectively.||mmHg||Standard Deviation|Mean
782733|NCT00807846|Secondary|Number of Participants With >= 30% Improvement in the Participant's Global Assessment of Overall Well-being at Week 6/Final Visit.|Participants, ≥8 years of age at the baseline, evaluated their own overall well-being at Baseline and at Week 6 (or Final Visit) by placing one vertical line on the VAS. The VAS ranges from 0 to 100, with 0 being ‘very well’ and 100 being ‘very poor’.|Week 6/Final Visit|MITT population was used. Additional 3 participants aged <8 yrs at Baseline in Naproxen Arm provided self-assessments. In Celecoxib Arm, 2 participants (>=8 yrs) not provided self-assessment and 2 (>=8 yrs) provided but they were not from MITT and were excluded; additional 1 participant (<8 yrs) provided self-assessment and included in analysis.||Participants|||Number
782734|NCT00807846|Secondary|Change From Baseline in Participant's Assessment of Overall Well-being at Week 6/Final Visit.|Participants, ≥8 years of age at the baseline, evaluated their own overall well-being at Baseline and at Week 6 (or Final Visit) by placing one vertical line on the VAS. The VAS ranges from 0 to 100, with 0 being ‘very well’ and 100 being ‘very poor’.|6 weeks|MITT population was used. Additional 3 participants aged <8 yrs at Baseline in Naproxen Arm provided self-assessments. In Celecoxib Arm, 2 participants (>=8 yrs) not provided self-assessment and 2 (>=8 yrs) provided but they were not from MITT and were excluded; additional 1 participant (<8 yrs) provided self-assessment and included in analysis.||mm||Standard Error|Least Squares Mean
782735|NCT00807846|Secondary|Number of Participants With >= 30% Improvement in the Parent’s Global Assessment of Overall Well-being at Week 6/Final Visit.|The parent/legal guardian evaluated the participant's overall well-being at Baseline and at Week 6 (or Final Visit) by placing one vertical line on the visual analog scale (VAS). The VAS ranged from 0 to 100, with 0 being ‘very well’ and 100 being ‘very poor.|Week 6/Final Visit|The MITT Population included all randomized participants who received at least one dose of study medication and had at least one post-baseline efficacy measurement.||Participants|||Number
782736|NCT00807846|Secondary|Change From Baseline in Parent's Assessment of Overall Well-being at Week 6/Final Visit.|The parent/legal guardian evaluated the participant's overall well-being at Baseline and at Week 6 (or Final Visit) by placing one vertical line on the visual analog scale (VAS). The VAS ranged from 0 to 100, with 0 being ‘very well’ and 100 being ‘very poor.|6 weeks|Modified-Intent-to-Treat (MITT) Population included all randomized participants who received at least one dose of study medication and had at least one post-baseline efficacy measurement.||mm (millimeter)||Standard Error|Least Squares Mean
782737|NCT00807846|Secondary|Change From Baseline in DBP at Week 6/Final Visit|Value at 6 weeks/Final Visit minus value at baseline.|6 weeks|"Safety population included all randomized participants who received at least one dose of study medication. The Safety Analysis set was used to analyze all BP measurements.
For early terminations the LOCF was used to impute missing data."||mmHg||Standard Error|Least Squares Mean
782739|NCT00807846|Secondary|Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2.|Value at 2 weeks minus value at baseline.|2 weeks|"Safety population included all randomized participants who received at least one dose of study medication. The Safety Analysis set was used to analyze all BP measurements.
For early terminations the LOCF was used to impute missing data."||mmHg||Standard Error|Least Squares Mean
782740|NCT00807846|Secondary|Change From Baseline in SBP at Week 4.|Value at 4 weeks minus value at baseline.|4 weeks|"Safety population included all randomized participants who received at least one dose of study medication. The Safety Analysis set was used to analyze all BP measurements.
For early terminations the LOCF was used to impute missing data."||mmHg||Standard Error|Least Squares Mean
782741|NCT00807846|Secondary|Change From Baseline to Week 2 in SBP.|Value at 2 weeks minus value at baseline.|2 weeks|"Safety population included all randomized participants who received at least one dose of study medication. The Safety Analysis set was used to analyze all BP measurements.
For early terminations the LOCF was used to impute missing data."||mmHg||Standard Error|Least Squares Mean
782742|NCT00807846|Primary|Change From Baseline in Systolic Blood Pressure (SBP) at Week 6/Final Visit|Value at 6 weeks minus value at baseline.|6 Weeks/Final Visit|"Safety population included all randomized participants who received at least one dose of study medication. The Safety Analysis set was used to analyze all BP (blood pressure) measurements.
For early terminations the last observation carried forward (LOCF) was used to impute missing data."||mmHg (millimeter of mercury)||Standard Error|Least Squares Mean
782743|NCT00807885|Secondary|Time Required to Infuse 1000 mL Fluid||from start of Lactated Ringer's (LR) infusion until 1000 mL LR infused|ITT (all treated subjects)||hours||Standard Deviation|Mean
782744|NCT00807885|Secondary|Time Needed to Successfully Place Subcutaneous Catheter/Button||from start of first attempt until completion of catheter/button placement|ITT (all treated subjects)||seconds||Full Range|Median
782745|NCT00807885|Secondary|Attempts Needed to Successfully Place Subcutaneous Catheter/Button||from start of first attempt until completion of catheter/button placement|ITT (all treated subjects)||participants|||Number
782746|NCT00807885|Primary|Technical Challenges|Protocol-specified challenges encountered during subcutaneous (SC) hylenex administration and/or SC infusion of Lactated Ringer's solution, including SC catheter kinking, catheter/button dislodgement, catheter/button pull-out, infusion pump alarm, other pump failure, healthcare provider intervention to secure/maintain SC infusion eg, re-taping, catheter/button manipulation, etc, and any other type of technical challenge encountered|throughout subcutaneous hylenex and fluid administration period (continuous)|ITT (all treated subjects)||participants|||Number
782747|NCT00807937|Secondary|Change in Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) Percent Maximum Total Score|"Q-LES-Q total score is the sum of the first 14 times of Q-LES-Q, and this total score is converted to a % maximum total score by : Q-LES-Q total score /70 x 100%, Larger values indicate a higher perceived quality of life enjoyment and satisfaction.
Change : percentage at week 4 minus percentage at randomization"|Baseline to week 4|||percentage||Standard Error|Least Squares Mean
782748|NCT00807937|Secondary|Change in Somatic Symptoms as Measured by HAM-A Somatic Cluster Score|The HAM-A Somatic cluster score 0-28 units consists of 7 questions scored on scale of 0-4 (0=Not present, 4=Very severe ) . Higher scores indicate higher levels of psychic anxiety disorder.|Baseline to week 4|||Units on scale||Standard Error|Least Squares Mean
782749|NCT00807937|Secondary|Change in Psychic Anxiety Factor as Measured by HAM-A Psychic Cluster Score|"The HAM-A psychic anxiety cluster score 0-28 units consists of 7 questions scored on scale of 0-4 (0=Not present, 4=Very severe) . Higher scores indicate higher levels of psychic anxiety disorder.
Change: score at week 4 minus score at randomization"|Baseline to week 4|||Units on scale||Standard Error|Least Squares Mean
782750|NCT00807937|Secondary|Change in Hospital Anxiety and Depression Scale for Anxiety (HADS-A) Total Score|HADS-A total score 0-21 units, 0 is the best, Higher total scores indicate a higher severity of the mood or anxiety disorder Change : score at week 4 minus score at randomization|Baseline to week 4|||Units on scale||Standard Error|Least Squares Mean
782751|NCT00807937|Primary|Change in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score|HAM-A total score 0-56 units, 14 questions scored on scale of 0-4 (0= Not present, 4=Very severe) . Higher HAM-A scores indicate higher levels of anxiety Change : score at week 4 minus score at randomization|Baseline to week 4|||Units on scale||Standard Error|Least Squares Mean
782752|NCT00807989|Secondary|Seizure Free Rate for 52 Weeks at Initial Target Dose||52 weeks|||participants|||Number
782753|NCT00807989|Secondary|Seizure Free Rate for 24 Weeks at Initial Target Dose||24 weeks|||participants|||Number
782754|NCT00807989|Primary|Retention Rate After 52 Weeks Maintenance Period|* Retention rate means completion rate (CR), the proportion of patients who have completed the 60-week study as planned.|52 weeks|||participants|||Number
782755|NCT00808015|Other Pre-specified|Concomitant Drug Treatments||Baseline through Last observed study visit (Week 12 or ET)|FAS included all participants who received at least 1 dose of study medication.||Participants|||Number
782756|NCT00808015|Other Pre-specified|Median Duration of Treatment of Varenicline|The duration was defined as the total number of dosing days from first to last day of each study treatment.|Baseline through last observed study visit (Week 12 or ET)|FAS population included all participants who received at least 1 dose of study treatment. Missing values were excluded from analysis.||Days||Full Range|Median
782757|NCT00808015|Other Pre-specified|Average Daily Dose of Varenicline||Days 1-3, Days 4-7, Day 8 through last observed study visit (Week 12 or ET)|FAS population included all participants who received at least 1 dose of study treatment. Missing values were excluded from analysis. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.||mg||Full Range|Median
782758|NCT00808015|Other Pre-specified|Varenicline Prescription Status|Prescribed status was assessed using the following question in consent record form: Would a maintenance period of the drug be prescribed to the participant after this study ends (Yes/No). Missing values were recorded as 'unknown'.|After last observed study visit (Week 12 or ET)|FAS population included all participants who received at least 1 dose of study medication.||participants|||Number
782836|NCT00814775|Primary|To Compare the Time Required for Successful Intubation Between the Fastrach and CTrach LMA Devices in Patients With a Mallampati Score III and IV Without Use of Fiberoptic Bronchoscopy||from start of intubation to successfully intubated|||seconds||Inter-Quartile Range|Median
782759|NCT00808015|Secondary|Average Weekly Number of Cigarettes Smoked at Last Observed Study Visit|The average number of cigarettes smoked per day over the last 7 days was collected as a part of nicotine use inventory assessment through consent record form module which included a questionnaire: Did the participant smoke any cigarettes (even a puff) in last 7 days (Yes/No) and Did the participant use any other tobacco products (example- pipe, cigars, chew, snuff) in last 7 days (Yes/No).|Last observed study visit (Week 12 or ET)|FAS population included all participants who received at least 1 dose of study medication during study. Missing observations were not imputed and hence the participants analyzed were those without missing values (N=518).||cigarettes||Full Range|Median
782760|NCT00808015|Secondary|CO Level at Last Observed Study Visit|The CO level was measured from exhaled air of the participant using CO analyzer at the last observed study visit which was the last available CO level recorded after baseline. The CO level was only measured if it was a part of the usual practice at the site.|Last observed study visit (Week 12 or ET)|FAS population included all participants who received at least 1 dose of study medication during study. Missing observations were not imputed and hence the participants analyzed were those without missing values (N=115).||ppm||Standard Deviation|Mean
782761|NCT00808015|Secondary|Percentage of Participants With Smoking Abstinence Status From Week 3 to Week 11|Four criteria used for derivation of smoking abstinence status: if participant smoked any cigarettes (even a puff) in last 7 days (Yes/No); if participant used any other tobacco products in last 7 days (Yes/No); average number of cigarettes smoked per day over last 7 days (in cigarettes/day); CO level (positive: if more than 10 ppm; negative : if 0-10 ppm).Smoking abstinence status was determined as: smoking: if participant responded positively to at least 1 of above 4; quit: if participant responded negatively to all 4; unknown: if participant had missing information for all 4.|Week 3 through Week 11|At Week t (t = 3 to 11), the analysis population was “Observed Cases minus Week t” (OC minus Week t), that is (i-e), participants in FAS excluding missing values at the time point in question where OC was the subset of participants in FAS with observed (not missing) values.||percentage of participants|||Number
782762|NCT00808015|Secondary|Percentage of Participants With Smoking Abstinence Before Last Observed Study Visit|Four criteria used for derivation of smoking abstinence status: if participant smoked any cigarettes (even a puff) in last 7 days (Yes/No); if participant used any other tobacco products in last 7 days (Yes/No); average number of cigarettes smoked per day over last 7 days (in cigarettes/day); CO level (positive: if more than 10 ppm; negative : if 0-10 ppm).Smoking abstinence status was determined as: smoking: if participant responded positively to at least 1 of above 4; quit: if participant responded negatively to all 4; unknown: if participant had missing information for all 4.|Last observed study visit (Week 12 or early termination [ET])|FAS included all participants who received at least 1 dose of study medication.||percentage of participants||95% Confidence Interval|Number
782763|NCT00808015|Primary|Percentage of Participants With Smoking Abstinence at Week 12|Four criteria used for derivation of smoking abstinence status: if participant smoked any cigarettes (even a puff) in last 7 days (Yes/No); if participant used any other tobacco products in last 7 days (Yes/No); average number of cigarettes smoked per day over last 7 days (in cigarettes/day); CO level (positive: if more than 10 ppm; negative : if 0-10 ppm).Smoking abstinence status was determined as: smoking: if participant responded positively to at least 1 of above 4; quit: if participant responded negatively to all 4; unknown: if participant had missing information for all 4.|Week 12|Full analysis set (FAS) included all participants who received at least 1 dose of study medication||percentage of participants||95% Confidence Interval|Number
782764|NCT00808028|Other Pre-specified|Immunogloblulin G (IgG) Measured by Geometric Mean Titer (GMT) for Sub Family A and Sub Family B||Before Vaccination 1, 1 month after vaccination 2, 1 month after vaccination 3|mITT population included all randomized participants who received at least 1 vaccination and had at least 1 valid and determinate assay result. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.||Titer||95% Confidence Interval|Geometric Mean
782765|NCT00808028|Secondary|Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level||1 month before vaccination 1, 1 month after vaccination 2, 3|mITT population included all randomized participants who received at least 1 vaccination and had at least 1 valid and determinate assay result. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.||Percentage of participants|||Number
782766|NCT00808028|Primary|Percentage of Participants With Atleast One Adverse Event (AE): Stage 2||6 month after vaccination 3 up to 48 months|Safety population included participants who received at least 1 dose of study vaccine.||Percentage of participants|||Number
782767|NCT00808028|Primary|Percentage of Participants With Atleast One Adverse Event (AE): Stage 1||Vaccination 1 upto 1 Month after vaccination 3|Safety population included participants who received at least 1 dose of study vaccine.||Percentage of participants|||Number
782768|NCT00808028|Primary|Percentage of Participants With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 3||Before vaccination 1 up to 1 month after vaccination 3|mITT population included all randomized participants who received at least 1 vaccination and had at least 1 valid and determinate assay result. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.||Percentage of participants|||Number
782769|NCT00808028|Primary|Percentage of Participants With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 2||Before vaccination 1 up to 1 month after vaccination 2|mITT population included all randomized participants who received at least 1 vaccination and had at least 1 valid and determinate assay result. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.||Percentage of participants|||Number
782770|NCT00808067|Secondary|Annualized Rate of Subjects With Intra-Cranial Hemorrhage (ICH)|Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.|up to 43 months|SAF-FAS interval||percentage of subject-years|||Number
782771|NCT00808067|Secondary|Annualized Rate of Subjects With Any Bleeds (Major Plus Minor)|Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.|up to 43 months|SAF-FAS interval||percentage of subject-years|||Number
782772|NCT00808067|Secondary|Annualized Rate of Subjects With Minor Bleeds|"Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
Minor bleeds were clinical bleeds that did not fulfill the criteria for major bleeds. Minor bleeds were classified as associated with study medication discontinuation (temporary or permanent) or not."|up to 43 months|SAF-FAS interval||percentage of subject-years|||Number
782773|NCT00808067|Secondary|Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE), Pulmonary Embolism (PE), Myocardial Infarction (MI), All Cause Death and Major Bleed|Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.|up to 43 months|SAF-FAS interval||percentage of subject-years|||Number
782774|NCT00808067|Secondary|Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE), Pulmonary Embolism (PE), Myocardial Infarction, Vascular Death|Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.|up to 43 months|SAF-FAS interval||percentage of subject-years|||Number
782775|NCT00808067|Secondary|Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE) and All Cause Death|Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.|up to 43 months|SAF-FAS interval||percentage of subject-years|||Number
782776|NCT00808067|Secondary|Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE)|Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.|up to 43 months|SAF-FAS interval||percentage of subject-years|||Number
782777|NCT00808067|Secondary|Death, Annualized Rate of Subject Death|"Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
Deaths were classified as being vascular (sudden/arrhythmic, pump failure death, or other vascular, including bleeding) or non-vascular, due to other specified causes (e.g., malignancy), or of unknown etiology."|up to 43 months|SAF-FAS interval||percentage of subject-years|||Number
782778|NCT00808067|Secondary|Deep Vein Thrombosis, Annualized Rate of Subjects With DVT|"Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
Deep Vein Thrombosis (DVT) was generally documented by one of the following:
abnormal compression ultrasound (CUS),
an intraluminal filling defect on venography."|up to 43 months|SAF-FAS interval||percentage of subject-years|||Number
782779|NCT00808067|Secondary|Acute Myocardial Infarction (MI), Annualized Rate of Subjects With MI|"Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
a. In subjects not undergoing PCI or CABG a subject should have fulfilled at least 2 of the following: i. Typical prolonged severe chest pain or related symptoms or signs suggestive of MI. ii. Elevation of troponin or CK-MB to more than upper level of normal (ULN) or, if CK-MB was elevated at baseline, re-elevation to more than 50% increase above the previous level. iii. Development of significant Q-waves in at least 2 adjacent ECG leads. b. After percutaneous coronary intervention (within 24h). c. After coronary artery bypass grafting (within 72h). d. Silent myocardial infarction. e. Myocardial infarction could also have been demonstrated at autopsy."|up to 43 months|SAF-FAS interval||percentage of subject-years|||Number
782780|NCT00808067|Secondary|Pulmonary Embolism (PE), Annualized Rate of Subjects With PE|"Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
Pulmonary Embolism was generally documented by one of the following:
an intraluminal filling defect in segmental or more proximal branches on spiral CT scan
an intraluminal filling defect or an extension of an existing defect or a sudden cutoff of vessels more than 2.5 mm in diameter on the pulmonary angiogram
a perfusion defect of at least 75% of a segment with a local normal ventilation result (high-probability) on ventilation/perfusion lung scan (VPLS)
inconclusive spiral CT, pulmonary angiography or lung scintigraphy with demonstration of DVT in the lower extremities by compression ultrasound or venography."|up to 43 months|SAF-FAS interval||percentage of subject-years|||Number
782781|NCT00808067|Secondary|Non CNS Systemic Embolism (SEE), Annualized Rate of Subjects With Non-CNS SEE|"Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
Systemic embolism was an acute vascular occlusion of the extremities or any organ (kidneys, mesenteric arteries, spleen, retina or grafts), and was to be documented by angiography, surgery, scintigraphy, or autopsy."|up to 43 months|SAF-FAS interval||percentage of subject-years|||Number
782782|NCT00808067|Secondary|Stroke, Annualized Rate of Subjects With Stroke|"Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
Stroke was an acute onset of a focal neurological deficit of presumed vascular origin lasting for 24 hours or more or resulting in death. The stroke was categorized as ischemic or hemorrhagic or cause unknown based on computerized tomography (CT), magnetic resonance (MR) scanning or autopsy. Fatal stroke was defined as death from any cause within 30 days of stroke. Severity of stroke was assessed by modified Rankin score at discharge from hospital"|up to 43 months|SAF-FAS interval||percentage of subject-years|||Number
782783|NCT00808067|Primary|Major Bleeding, Annualized Rate of Subjects With Major Bleeds|"Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
Major bleeding must have satisfied one or more of the following criteria:
Bleeding associated with a reduction in hemoglobin of at least 20 g/L
Required transfusion of at least 2 units of blood or packed cells
Symptomatic bleeding in a critical area or organ: intraocular, intraspinal, intramuscular with compartment syndrome, retroperitoneal, intra-articular, pericardial, gastrointestinal
Major bleed were classified as life-threatening if they met one or more of the following criteria:
Reduction in hemoglobin of at least 50 g/L
Transfusion of at least 4 units of blood or packed cells
Symptomatic intracranial bleeding, either subdural or intracerebral
Associated with hypotension requiring use of intravenous inotropic agents
Required surgical intervention to stop bleeding
Resulted in death"|up to 43 months|SAF-FAS interval||percentage of subject-years|||Number
782837|NCT00814788|Secondary|Overall Survival|Overall survival was estimated using the Kaplan-Meier method.|Up to 3 years|||months||95% Confidence Interval|Median
782786|NCT00813800|Secondary|Young Mania Rating Scale (YMRS) at 12 Weeks|YMRS is an eleven-item, multiple choice diagnostic questionnaire which psychiatrists use to measure the severity of manic episodes in patients already diagnosed with mania. Lowest score = 0, normal subject; Highest score = 60, highly manic subject. For this scale the following scores are associated with these grades of severity: mania (YMRS = 20), hypomania (YMRS = 12), under 5 is classified as non-manic. Young RC, Biggs JT, Ziegler Ve, Meyer DA. A rating scale for mania: reliability, validity and sensitivity. BR J Psychiatry 1978; 133:429-435.|12 weeks|Intention to Treat (ITT)||Units on a Scale||Standard Deviation|Mean
782787|NCT00813800|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS) at 12 Weeks|MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. Each item on the MADRS is scaled 0 through 6. Lowest score = 0, would indicate no depressive symptoms. Highest score = 60, indicating extreme depression. MADRS score > 20 is syndromal depression. Montgomery SA, Asberg M. A new depression scale designed to be sensitive to change. Br J Psychiatry 1979; 134:382-389.|12 weeks|Intention to Treat (ITT)||Units on a Scale||Standard Deviation|Mean
782788|NCT00813800|Primary|Carbon Monoxide Breath Level at 12 Weeks|Measured by expired breath in parts per million (ppm)|12 weeks|Intention to Treat (ITT)||ppm||Standard Deviation|Mean
782789|NCT00813813|Secondary|Change in Mental Component Summary Quality of Life Measure Assessed by Short Form SF-36 at 12 Months From Baseline|The 36-item Short Form Health Survey (SF-36) is a patient reported outcome survey that evaluates functional health and well-being. The survey is converted into two summary measures (the Physical Component - PCS and Mental Component- MCS) that are scored from 0 to 100 (where 100 indicates the highest level of health).|12 Months|FAS Population||units on a scale||Standard Deviation|Mean
782790|NCT00813813|Secondary|Change in Physical Component Summary of Quality of Life Measure Assessed by Short-Form 36 at 12 Months From Baseline|The 36-item Short Form Health Survey (SF-36) is a patient reported outcome survey that evaluates functional health and well-being. The survey is converted into two summary measures (the Physical Component - PCS and Mental Component- MCS) that are scored from 0 to 100 (where 100 indicates the highest level of health).|12 Months|FAS Population||units on a scale||Standard Deviation|Mean
782791|NCT00813813|Secondary|Change in Pain Visual Analog Scale (VAS) at 12 Months From Baseline|The Visual Analog Scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line (that is approximately 10 cm long) with 'No Pain' (score of 0 = 0 cm) listed on the left and 'Very severe pain' (score of 10=10cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their back.|12 months|FAS Population||units on a scale||Standard Deviation|Mean
782792|NCT00813813|Primary|Treatment Emergent Adverse Events- Relationship to Study Drug|Number of patients with Treatment Emergent Adverse Events that were designated as related or possibly related to Study Drug.|Through a 12 month period and annual telephone contact at 24 and 36 months for subject health status follow-up|Safety Population||participants|||Number
782793|NCT00813813|Secondary|Change in Function Assessed by Oswestry Disability Index Change at 12 Months From Baseline|The Oswestry Disability Index (ODI) is a 10-category (Pain Intensity, Personal Care, Lifting, Walking, Sitting, Standing, Sleeping, Sex Life, Social Life, Traveling) disability measurement scale with a graded response from 0 to 5, with 0 being the best score (no impairment) to 5 being the worst score (significant impairment). ODI score for a subject is calculated by adding the scores and converting the score to a 100 point scale.|12 months|FAS Population||units on a scale||Standard Deviation|Mean
782794|NCT00813813|Primary|Neurological Assessment for Motor Function and Reflexes/Sensory|"Neurological Assessment for Motor Function and Reflexes/Sensory- Number of patients with Clinically Significant Abnormal results at 12 months.
For Motor Function, Clinically Significant Abnormal results are determined by the surgeon investigator and are further classified by grade: 0= No Movement, 1= Flicker/trace of contraction, 2=Active movement when gravity removed, 3= Active movement against gravity, 4= Active Movement against gravity and resistance.
For Reflexes/Sensory, Clinically Significant Abnormal results are determined by the surgeon investigator and are based on exams of the Knee, Ankle, L3-L5 Dermatone, and S1 Dermatome. Tension signs are evaluated with a straight leg raise to determine at which point, if any, sciatic pain occurs."|12 months|Safety Population||participants|||Number
782795|NCT00813904|Secondary|Number of Participants With AEs by Maximum Severity|An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. AE severity was assessed using Common Terminology Criteria for Adverse Events, Version 13.0: Grade 1=mild; Grade 2=moderate; Grade 3=severe; Grade 4=life-threatening; Grade 5=fatal.|Baseline to Day 29, continuously|All participants who received treatment with rThrombin.||Participants|||Number
782796|NCT00813904|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Adverse Events (AEs), Treatment-related Adverse Events, and AEs Leading to Discontinuation|An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. Treatment-related=possibly, probably, or certainly related to and of unknown relationship to study treatment.|Baseline through Day 29, continuously|All participants who received treatment with rThrombin.||Participants|||Number
782797|NCT00813904|Primary|Number or Participants With Antirecombinant Thrombin (rThrombin) Product Antibody at Baseline and Day 29|Immunogenicity of rThrombin product was evaluated using an enzyme-linked immunosorbent assay for detection of antirThrombin product antibody and a neutralizing antibody assay to characterize the potential of antibodies to rThrombin product to neutralize the activity of human plasma-derived thrombin.|At baseline and Day 29|Participants who received treatment with rThrombin and had data available from both baseline and Day 29 antibody assessments.||Participants|||Number
782798|NCT00813917|Primary|7-day Point Prevalence All Tobacco Abstinence|7-day point prevalence all tobacco abstinence at week 12 (end of treatment)confirmed by urine cotinine less than 50ng/ml|12 weeks - end of treatment|||participants|||Number
782838|NCT00814788|Secondary|Progression-free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Up to 2 years|||months||95% Confidence Interval|Median
782799|NCT00813943|Secondary|Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) and Lab Parameters||Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)|Any clinically significant abnormal ECG and lab finding was planned to be reported as AE only so they have been captured in the below mentioned adverse event section|||||
782800|NCT00813943|Secondary|Number of Participants With AEs Belonging to Standardized Medical Dictionary for Regulatory Activities (MedDRA) Queries (SMQs) Thromboembolic Events and Hemorrhage With NCI−CTC Toxicity Grade 3 or 4|Thromboembolic events (standardized MedDRA query [SMQ]) Grade 3 or 4 AEs encompassed hemiparesis and cerebrovascular accident, pulmonary embolism, and deep vein thrombosis. Thromboembolic events (SMQ) of any grade and of Grade 3 or 4 were generally more frequent in the Cilengitide + Temozolomide/Radiotherapy group than in the Temozolomide/Radiotherapy group but were still in the expected range of this patient population The severity of AEs was assessed according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTCAE) (version 3.0): Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening or disabling. Note: Death (Grade 5) was regarded as an outcome.|Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)|Safety population included all the participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. According to trial design safety data in trial arms (Cilengitide vs Control) were collected based on different visit frequency and different safety surveillance period.||Participants|||Number
782801|NCT00813943|Secondary|Number of Participants With Adverse Events (AEs), Serious AEs, Treatment-Related AEs, Treatment-Related Serious AEs, AEs Leading to Death, Treatment-Related AEs Leading to Death, AEs of Grade 3 or 4 and Treatment-Related AEs of Grade 3 or 4|An AE is defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. Treatment-emergent AEs are the events between first dose of study drug and up to 28 days after last dose of study treatment. A Serious AE is an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. Treatment-related AEs are the AEs which are suspected to be reasonably related to the study treatment (cilengitide, or radiotherapy, or temozolomide) as per investigator assessment. The severity of AEs was assessed according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTCAE) (Version 3.0): Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening or disabling. Note: Death (Grade 5) was regarded as an outcome.|Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)|Safety population included all the participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. According to trial design safety data in trial arms (Cilengitide vs Control) were collected based on different visit frequency and different safety surveillance period.||Participants|||Number
782802|NCT00813943|Secondary|Apparent Volume of Distribution During the Terminal Phase (Vz) and Apparent Volume of Distribution at Steady State (Vss)|The Vz (after single dose) and Vss (after repeated doses) for cilengitide were calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2. Cilengitide plasma concentrations were determined after dosing on Day 1 (single dose) and Day 5 (repeated doses) of Week 1.|Days 1 and 5 of Week 1|"Only Cilengitide (5-times) + Temozolomide + Radiotherapy group was analyzed for this outcome measure as per planned analysis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure."||liter||Standard Deviation|Mean
782803|NCT00813943|Secondary|Plasma Clearance (CL)|The CL for cilengitide was calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2. Cilengitide plasma concentrations were determined after dosing on Day 1 (single dose) and Day 5 (repeated doses) of Week 1.|Days 1 and 5 of Week 1|"Only Cilengitide (5-times) + Temozolomide + Radiotherapy group was analyzed for this outcome measure as per planned analysis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure."||milliliter per minute||Standard Deviation|Mean
782804|NCT00813943|Secondary|Mean Residence Time From Time 0 to Infinity (MRT [0-infinity])|The MRT (0-infinity) for cilengitide was calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2. Cilengitide plasma concentrations were determined after dosing on Day 1 (single dose) and Day 5 (repeated doses) of Week 1.|Days 1 and 5 of Week 1|"Only Cilengitide (5-times) + Temozolomide + Radiotherapy group was analyzed for this outcome measure as per planned analysis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure."||hour||Standard Deviation|Mean
782805|NCT00813943|Secondary|Apparent Terminal Rate Constant|The apparent terminal rate constant for cilengitide was calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2. Cilengitide plasma concentrations were determined after dosing on Day 1 (single dose) and Day 5 (repeated doses) of Week 1.|Days 1 and 5 of Week 1|"Only Cilengitide (5-times) + Temozolomide + Radiotherapy group was analyzed for this outcome measure as per planned analysis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure."||per hour||Standard Deviation|Mean
782806|NCT00813943|Secondary|Plasma Concentration at Pre-dose (Cpre) and Plasma Concentration at End of Infusion (CT)|The Cpre and CT for cilengitide were calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2. Cilengitide plasma concentrations were determined after dosing on Day 1 (single dose) and Day 5 (repeated doses) of Week 1.|Days 1 and 5 of Week 1|"Only Cilengitide (5-times) + Temozolomide + Radiotherapy group was analyzed for this outcome measure as per planned analysis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. One participant had implausible pre-dose concentration."||ng/mL||Standard Deviation|Mean
782807|NCT00813943|Secondary|Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC [0-infinity]) and Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC [0-24])|The AUC (0-infinity) and AUC (0-24) for cilengitide were calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2. Cilengitide plasma concentrations were determined after dosing on Day 1 (single dose) and Day 5 (repeated doses) of Week 1.|Days 1 and 5 of Week 1|"Only Cilengitide (5-times) + Temozolomide + Radiotherapy group was analyzed for this outcome measure as per planned analysis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure."||hour*ng/mL||Standard Deviation|Mean
782808|NCT00813943|Secondary|Time to Maximum Plasma Concentration (Tmax) and Terminal Elimination Half-Life (t1/2)|The Tmax and t1/2 for cilengitide were calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2. Cilengitide plasma concentrations were determined after dosing on Day 1 (single dose) and Day 5 (repeated doses) of Week 1.|Days 1 and 5 of Week 1|"Only Cilengitide (5-times) + Temozolomide + Radiotherapy group was analyzed for this outcome measure as per planned analysis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure."||hours||Standard Deviation|Mean
782809|NCT00813943|Secondary|Maximum Observed Plasma Concentration (Cmax)|The Cmax for cilengitide was calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2. Cilengitide plasma concentrations were determined after dosing on Day 1 (single dose) and Day 5 (repeated doses) of Week 1.|Days 1 and 5 of Week 1|"Only Cilengitide (5-times) + Temozolomide + Radiotherapy group was analyzed for this outcome measure as per planned analysis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure."||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
782810|NCT00813943|Secondary|Progression Free Survival (PFS) Time - Investigator and Independent Read|The PFS time is defined as the duration from randomization to either first observation of progressive disease (PD) or occurrence of death due to any cause. Investigator read is the assessment of all imaging by the treating physician at the local trial site. Independent Read is the assessment of all imaging centrally by an Independent Review Committee (IRC).|Time from randomization to disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date, (07 Feb 2013)|ITT population included all the participants who were randomized to study treatment.||Months||95% Confidence Interval|Median
782811|NCT00813943|Primary|Overall Survival (OS) Time|The OS time is defined as the time (in months) from randomization to death or last day known to be alive. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.|Time from randomization to death or last day known to be alive, reported between day of first participant randomized, that is, Jun 2009 until cut-off date, (07 Feb 2013)|ITT population included all the participants who were randomized to study treatment.||Months||95% Confidence Interval|Median
782812|NCT00813982|Primary|Overall Vision|Overall vision was interpreted by the subject and recorded on a questionnaire as a single, retrospective evaluation of 1-week wear time. Overall vision was evaluated by eye and rated on a 10-point scale, with 1 being poor and 10 being excellent.|1 week|Per Protocol. Two participants were excluded from analysis due to major protocol deviations as determined by masked review. One participant was not analyzed due to discontinuation.||Units on a Scale||Standard Deviation|Mean
782813|NCT00813995|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Change from baseline at Week 24 is defined as Week 24 minus Week 0.|Baseline and Week 24|Full Analysis Set (defined as a subset of all randomized participants who received at least one dose of double-blind study medication, and had both a baseline [randomization] measurement and a post-randomization measurement) using last observation carried forward for missing data.||mg/dL||95% Confidence Interval|Least Squares Mean
782814|NCT00813995|Secondary|Change From Baseline in 2-hour Post-meal Glucose (PMG) at Week 24|Change from baseline at Week 24 is defined as Week 24 minus Week 0.|Baseline and Week 24|Full Analysis Set (defined as a subset of all randomized participants who received at least one dose of double-blind study medication, and had both a baseline [randomization] measurement and a post-randomization measurement) using last observation carried forward for missing data.||mg/dL||95% Confidence Interval|Least Squares Mean
782815|NCT00813995|Secondary|Change From Baseline in Hemoglobin A1c (A1C) at Week 24 for Participants on Metformin 1700 mg/Day|A1C is measured as percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.|Baseline and Week 24|Full Analysis Set (defined as a subset of all randomized participants who received at least one dose of double-blind study medication, and had both a baseline [randomization] measurement and a post-randomization measurement) using last observation carried forward for missing data.||Percent||95% Confidence Interval|Least Squares Mean
782816|NCT00813995|Secondary|Change From Baseline in Hemoglobin A1c (A1C) at Week 24 for Participants on Metformin 1000 mg/Day|A1C is measured as percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.|Baseline and Week 24|Full Analysis Set (defined as a subset of all randomized participants who received at least one dose of double-blind study medication, and had both a baseline [randomization] measurement and a post-randomization measurement) using last observation carried forward for missing data.||Percent||95% Confidence Interval|Least Squares Mean
782817|NCT00813995|Primary|Change From Baseline in Hemoglobin A1c (A1C) at Week 24|A1C is measured as percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.|Baseline and Week 24|Full Analysis Set (defined as a subset of all randomized participants who received at least one dose of double-blind study medication, and had both a baseline [randomization] measurement and a post-randomization measurement) using last observation carried forward for missing data.||Percent||95% Confidence Interval|Least Squares Mean
782818|NCT00814710|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Following first vaccination (Month 0) throughout the entire study period (month 3)|Analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||subjects|||Number
782819|NCT00814710|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|"An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms"|Within 31 days (day 0-30) after vaccination|Analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||subjects|||Number
782839|NCT00814788|Primary|PSA Response Rate|The PSA response rate was defined as a 30% reduction in the PSA level from baseline. PSA Working Group consensus criteria combined with radiographic studies were used to determine the proportion of patients with PSA decline.|Up to 2 years|||Participants|||Count of Participants
782820|NCT00814710|Secondary|Number of Subjects With Solicited Local and General Symptoms|Solicited local symptoms included pain, redness and swelling. Solicited general symptoms included drowsiness, fever (equal to or above 38 degrees Celsius and above 39 degrees Celsius), irritability and loss of appetite.|Within 4 days (day 0-3) after vaccination|Analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects. However, the total number of subjects analyzed in this Total Vaccinated cohort included all subjects having returned their symptom sheets.||subjects|||Number
782821|NCT00814710|Secondary|Number of Seroprotected Subjects (Anti-PRP Above the Cut-off of 1.0 µg/mL)|Anti-PRP antibody concentration equal to or greater than 1.0 µg/mL.|One month after primary immunization (month 3)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.||subjects|||Number
782822|NCT00814710|Primary|Concentration of Antibody Against Protein D (PD)|Concentrations were expressed as GMCs GSK’s 22F-inhibition in enzyme-linked-immunosorbent assay (ELISA) units per milliliter (EL.U/mL).|One month after primary immunization (month 3)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.||EL.U/mL||95% Confidence Interval|Geometric Mean
782823|NCT00814710|Secondary|Number of Seroprotected Subjects (Anti-DT, Anti-TT, Anti-PRP, Anti-HBs)|"Seroprotection was defined as:
Anti-DT antibody concentration equal to or greater than 0.1 IU/mL. Anti-TT antibody concentration equal to or greater than 0.1 IU/mL. Anti-PRP antibody concentration equal to or greater than 0.15 µg/mL Anti-HBs antibody concentration greater than or equal to 10 mIU/mL."|One month after primary immunization (month 3)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.||subjects|||Number
782824|NCT00814710|Secondary|Number of Subjects Seropostive for B. Pertussis|Seropositivity was defined as and antibody concentration equal to or greater than 15 EL.U/mL.|One month after primary immunization (month 3)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.||subjects|||Number
782825|NCT00814710|Secondary|Concentration of Antibody Against Hepatitis B (Anti-HBs)|Concentration was expressed as GMC in milli international units per milliliter (mIU/mL).|One month after primary immunization (month 3)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.||mIU/mL||95% Confidence Interval|Geometric Mean
782826|NCT00814710|Secondary|Concentration of Antibody Against Bordetella Pertussis (B. Pertussis)|Concentration was expressed as GMC in EL.U/mL.|One month after primary immunization (month 3)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.||EL.U/mL||95% Confidence Interval|Geometric Mean
782827|NCT00814710|Secondary|Concentration of Antibodies Against Diphteria (Anti-DT) and Tetanus (Anti-TT)|Concentrations were expressed as GMCs in international units per milliliter (IU/mL).|One month after primary immunization (month 3)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.||IU/mL||95% Confidence Interval|Geometric Mean
782828|NCT00814710|Secondary|Concentration of Antibody Against Polyribosyl-ribitol Phosphate (PRP)|Concentration is expressed as GMC in µg/mL.|One month after primary immunization (month 3)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.||µg/mL||95% Confidence Interval|Geometric Mean
782829|NCT00814710|Secondary|Number of Subjects Seropositive for Protein D (PD)|Seropositivity for PD was defined greater than or equal to 100 EL.U/mL.|One month after primary immunization (month 3)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.||subjects|||Number
782830|NCT00814710|Secondary|Number of Subjects Seropositive for Pneumococcal Serotypes|"Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Cross-reactive pneumococcal serotypes included 6A and 19A.
Seropositivity was defined as a titer equal to or greater than 0.05 µg/mL"|One month after primary immunization (month 3)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.||subjects|||Number
782831|NCT00814710|Secondary|Concentrations of Antibodies Against Pneumococcal Cross-reactive Serotypes|Concentrations were expressed as GMCs in µg/mL. Pneumococcal cross-reactive serotypes included 6A and 19A.|One month after primary immunization (month 3)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.||µg/mL||95% Confidence Interval|Geometric Mean
782832|NCT00814710|Secondary|Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes Equal to or Above Cut-off Value|"Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Cross-reactive pneumococcal serotypes included 6A and 19A.
The cut-off was defined as 0.20 microgram per milliliter (µg/mL)."|One month after primary immunization|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.||subjects|||Number
782833|NCT00814710|Secondary|Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes|"Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
Cross-reactive pneumococcal serotypes included 6A and 19A.
Opsonophagocytic activity was defined as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay was an opsonic titer equal to or greater than 8."|One month after primary immunization (month 3)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.||subjects|||Number
782834|NCT00814710|Primary|Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes|"Concentrations were expressed as Geometric Mean Concentrations (GMCs) in microgram per milliliter (µg/mL).
Pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F."|One month after primary immunization (month 3)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.||µg/mL||95% Confidence Interval|Geometric Mean
782835|NCT00814775|Primary|To Compare the Time Required for Successful Intubation Between the Fastrach and CTrach LMA Devices in Patients With a Mallampati Score III and IV Use of Fiberoptic Bronchoscopy||60 seconds|||seconds||Inter-Quartile Range|Median
782840|NCT00814801|Secondary|Change From Baseline in the Mental Function Impairment Scale (MENFIS)|MENFIS is a Clinician's Interview-Based Impression of Change (CIBIC) plus-Japan subscale that rates the patient's severity for mental function impairment. This seven-point scale varies from 0 (= absolutely no impairment) to 6 (=complete impairment).|Baseline and 24 weeks|Intent-to-treat (ITT) population. Last observation carried forward (LOCF) end point.||Scores on a scale||Standard Deviation|Mean
782841|NCT00814801|Secondary|Change From Baseline in the Behavioral Pathology in Alzheimer's Disease Rating Scale (Behave-AD)|Behave-AD is a CIBIC plus-J subscale that rates the patient's severity of psychotic symptoms. This four-point scale varies from 0 (=none) to 3 (= serious).|Baseline and 24 weeks|Intent-to-treat (ITT) population. Last observation carried forward (LOCF) end point.||Scores on a scale||Standard Deviation|Mean
782842|NCT00814801|Secondary|Change From Baseline in the Disability Assessment for Dementia (DAD)|Each of the 40 item of the DAD is scored as 1 point= Yes, 0 point= No, or non applicable= N/A. A total score (minimum=0; maximum=40) is the sum of points for each questions converted out 100. Items rated as Not Applicable (N/A) are not considered for the total score. The final score is a percentage that gives an appreciation of global function in activity of daily life (ADL). Higher scores represent less disability in ADL while lower scores indicate more dysfunction.|Baseline and 24 weeks|Intent-to-treat (ITT) population. Last observation carried forward (LOCF) end point.||Scores on a scale||Standard Deviation|Mean
782843|NCT00814801|Primary|Distribution of Clinician's Interview-Based Impression of Change Plus - Japan (CIBIC Plus-J)|"CIBIC plus-J is the Japanese version of the Clinician's Interview-based Impression of Change plus the caregiver's input (CIBIC plus). It is a seven-point categorical assessment scale for evaluating the efficacy of antidementia drugs, ranging from markedly improved” to “markedly worse”."|24 weeks|Intent-to-treat (ITT) population. Last observation carried forward (LOCF) end point.||patients|||Number
782844|NCT00814801|Primary|Change From Baseline in the Alzheimer's Disease Assessment Scale - Japan Cognitive Subscale (ADAS-J Cog)|ADAS-J cog is the Japanese version of the cognitive function subscale of the Alzheimer's disease assessment scale (ADAS). This scale is used to detect changes in cognitive function in individuals with Alzheimer disease on the basis of three domains: memory, language and behavior. The minimum score is zero (0) and means well cognitive function. The maximum total score is 70 points, and the larger the score, the more severe the degree of impairment.|Baseline and 24 weeks|Intent-to-treat (ITT) population. Last observation carried forward (LOCF) end point.||Scores on a scale||Standard Deviation|Mean
782845|NCT00814879|Secondary|Mean Change in Total Bilirubin (mg/dL) From Baseline|mean change in total bilirubin from baseline|baseline and 48 weeks|||mg/dL||Standard Deviation|Mean
782846|NCT00814879|Secondary|Cholesterol|Total cholersterol (mg/dL)|baseline, week 24, week 48|||mg/dL||Standard Deviation|Mean
782847|NCT00814879|Secondary|CD4+ Cell Count||Week 48|||cells/mm^3||Standard Deviation|Mean
782848|NCT00814879|Secondary|CD4+ Cell Count||Weeks 24|||cells/mm^3||Standard Deviation|Mean
782849|NCT00814879|Secondary|Number of Patients With < 400 Copies HIV RNA/mL at Week 48||48 weeks|||participants|||Number
782850|NCT00814879|Primary|Number of Patients Reaching Virologic Failure at Week 48.|Virologic failure was defined by protocol as a plasma HIV RNA >50 c/mL on 2 consecutive occasions >7 days apart or > 10 000 c/mL on one occasion (in the absence of an intercurrent infection or recent immunization).|48 Weeks|||participants|||Number
782851|NCT00814892|Secondary|Progression Free Survival (PFS)|PFS based on radiographic criteria was defined as the time from registration to the time of radiographic progression. A confirmed progression was defined as one for which radiological evidence of a new lesion is found following CT and/or bone scans.|Up to 3 years|Since only two participants were accrued, patient confidentiality prevents the reporting of these two participants.|||||
782852|NCT00814892|Secondary|Change From Baseline in Quality of Life (QOL) as Measured by the EORTC QLQ-C30 Questionnaire|"European Orgnisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30 for cancer patients composed of 5 functional scales, 3 symptom scales, a global health status QOL scale, and six single items. Scores for each scale/item were calculated according to the questionnaire's scoring algorithm and range in 0 to 100, with high score represents high healthy level of functioning, high QOL or high level of symptomatology/problems. Change: Scores at cycle 1 minus scores at baseline.
Change from baseline in QOL will also be evaluated at cycle 6, 10, 15 and every 6 months during observation phase."|Baseline and cycle 1|Since only two participants were accrued, patient confidentiality prevents the reporting of these two participants.|||||
782853|NCT00814892|Secondary|Duration of PSA-based Response|"PSA-based response was defined as a PSA decline of at least 50%, which must be confirmed by a second PSA value in 4 or more weeks later.
The duration of PSA-based response are measured from the first time point at which the PSA has declined by at least 50% (which must eventually be confirmed by a second value) until PSA has increased back to 50% of the original on-study value."|Up to 3 years|Since only two participants were accrued, patient confidentiality prevents the reporting of these two participants.|||||
782854|NCT00814892|Secondary|Time to Prostate-specific Antigen (PSA) Progression|"In patients whose PSA has not decreased, progressive disease is a 25% increase over the baseline (on-study) and an increase in the absolute-value PSA level by at least 5 ng/mL, which is confirmed by a second value. In patients whose PSA has decreased but has not reached response criteria, progressive disease would be considered to have occurred when PSA increases 25% over the nadir, provided that the increase is a minimum of 5 ng/mL and is confirmed.
The start of the time to PSA progression is the day treatment is initiated. If at least a 50% decline in PSA has been achieved, the end date is the time the PSA has increased 50% above the nadir at a minimum of 5 ng/mL (this is the same as the parameter for PSA response). For patients without a PSA decrease of this magnitude (or no decrease in PSA), the end point for progression will be calculated at the time a 25% increase in PSA has been achieved (see above). All end dates require a confirmatory PSA."|Registration to PSA progression (Up to 3 years)|Since only two participants were accrued, patient confidentiality prevents the reporting of these two participants.|||||
782855|NCT00814892|Secondary|Time to Prostate-cancer Specific Mortality||Registration to Prostate-cancer specific mortality (Up to 3 years)|Since only two participants were accrued, patient confidentiality prevents the reporting of these two participants.|||||
782876|NCT00814983|Secondary|Rate of Immune Recovery|The time to recovery of T-cell subset, B cell and NK cell recovery will be monitored along with T-Cell proliferative response to mitogens.|3 years|No analysis was performed since the experimental arm was not opened|||||
782856|NCT00814892|Secondary|Number of Participants With Severe Adverse Events|Severe adverse events were defined as grade 3 or higher, regardless of attribution to study drugs. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.|Every cycle during treatment (up to 14 cycles)|Since only two participants were accrued, patient confidentiality prevents the reporting of these two participants.|||||
782857|NCT00814892|Primary|Number of Participants Who Are Progression Free at One Year|Progression free was defined as being free of radiographically detectable disease/metastases at one year after registration and having a prostate-specific antigen (PSA) level <200.0 ng/mL.|One year|Since only two participants were accrued, patient confidentiality prevents the reporting of these two participants.|||||
782858|NCT00814970|Secondary|Percentage of Participants Free From Strut Fractures|Defined as percent free from strut fractures. Percentage based on number of stents implanted with flat plate x-ray follow-up at the 36 month timepoint.|36 Months|Intention-to-Treat||percentage of participants|Participants||Number
782859|NCT00814970|Secondary|Major Adverse Event (MAE) Rate|Major Adverse Events (MAE) defined as device and/or procedure related death (or any death occurring post-procedure through Day 30), target limb loss and target lesion or target vessel revascularization at the 36 month timepoint.|36 Months|Intention-to-Treat||percentage of participants|||Number
782860|NCT00814970|Secondary|Percentage of Participants Free From Strut Fractures|Defined as percent free from strut fractures. Percentage based on number of stents implanted with flat plate x-ray follow-up at the 24 month timepoint.|24 Months|Intention-to-Treat (ITT)||percentage of participants|Participants||Number
782861|NCT00814970|Secondary|Major Adverse Event (MAE) Rate|Major Adverse Events (MAE) defined as device and/or procedure related death (or any death occurring post-procedure through Day 30), target limb loss and target lesion or target vessel revascularization at the 24 month timepoint.|24 Months|Intention-to-Treat||percentage of participants|||Number
782862|NCT00814970|Secondary|Clinically-driven Target Lesion Revascularization (TLR) Rate|Defined as those revascularizations in which the subject has ischemic symptoms consistent with changes within the target lesion as demonstrated by: a change (decrease from post-procedure) in the Rutherford scale by at least one category, or a change (decrease from post-procedure) in ABI/TBI >= 0.15|12 Months|Intention-to-Treat (ITT)||percentage of participants|||Number
782863|NCT00814970|Secondary|Percentage of Participants Free From Strut Fractures|Defined as percent free from strut fractures. Percentage based on number of stents implanted with flat plate x-ray follow-up.|12 Months|Intention-to-Treat (ITT)||percentage of participants|Participants||Number
782864|NCT00814970|Secondary|Change in Quality of Life - Decrease in Rutherford Class >= 1 Category|Decline in Rutherford class ≥ 1 category at 30 days when compared to pre-procedure according to the Rutherford Scale Classification. The Rutherford Classification is a categorical scale (0 - 6) used by clinicians to assess the degree of peripheral arterial disease in a person. The scale begins with 0 (no symptoms) and ends with 6 (worse case symptoms).|30 Days|Intention-to-Treat (ITT)||percentage of participants|||Number
782865|NCT00814970|Secondary|Change in Quality of Life - Increase in Ankle-brachial Index (ABI) or Toe-brachial Index (TBI) >= 0.15|Increase in ABI/TBI ≥ 0.15 at 12 months from pre-procedure. An increase in ABI/TBI of 0.15 or greater is considered by clinicians to be a significant improvement.|12 Months|Intention-to-Treat (ITT)||percentage of participants|||Number
782866|NCT00814970|Secondary|Change in Quality of Life - Improvement in Rutherford Class by >= 1 Category|Improvement in Rutherford class by ≥ 1 category increase at 12 months from pre-procedure according to the Rutherford Scale Classification. The Rutherford Classification is a categorical scale (0 - 6) used by clinicians to assess the degree of peripheral arterial disease in a person. The scale begins with 0 (no symptoms) and ends with 6 (worse case symptoms).|12 months|Intention-to-Treat (ITT)||percentage of participants|||Number
782867|NCT00814970|Secondary|Secondary Patency Rate|Defined as vessel patency resulting from any procedure that restores patency.|12 Months|Intention-to-Treat (ITT)||percentage of participants|||Number
782868|NCT00814970|Secondary|Assisted Primary Patency|Defined as vessel patency resulting from a procedure performed in the treated segment.|12 months|Intention-to-Treat (ITT)||percentage of participants|||Number
782869|NCT00814970|Secondary|Procedure Success|The outcome is based on the angiographic evidence of <30% final residual stenosis of the target lesion after stent implantation and no occurrence of a procedure-related Major Adverse Events (MAE) prior to hospital discharge.|At time of deployment to time of hospital discharge|Intention-to-Treat (ITT)||percentage of lesions treated|||Number
782870|NCT00814970|Secondary|Lesion Success|The outcome is based on the angiographic evidence of <30% final residual stenosis of the target lesion using either the Complete SE SFA Stent System or other standard percutaneous devices.|At time of deployment to the end of the treatment procedure (removal of vascular sheath from the patient).|Intention-to-Treat (ITT)||percentage of lesions treated|||Number
782871|NCT00814970|Secondary|Device Success|The outcome is based on the angiographic evidence of <30% final residual stenosis of the target lesion using only the assigned device.|At time of deployment to the end of the treatment procedure (removal of vascular sheath from the patient).|Intention-to-Treat (ITT)||percentage of lesions treated|||Number
782872|NCT00814970|Secondary|Major Adverse Event (MAE) Rate|Major Adverse Events (MAE) defined as device and/or procedure related death (or any death occurring post-procedure through Day 30), target limb loss and target lesion or target vessel revascularization at the 6 month timepoint.|6 Months|Intention-to-Treat (ITT)||percentage of participants|||Number
782873|NCT00814970|Secondary|Major Adverse Event (MAE) Rate|Major Adverse Events (MAE) defined as device and/or procedure related death (or any death occurring post-procedure through Day 30), target limb loss and target lesion or target vessel revascularization at the 30 day timepoint.|30 days|Intention-to-Treat (ITT)||percentage of participants|||Number
782874|NCT00814970|Primary|Primary Patency Rate|Primary patency defined as uninterrupted patency with no procedures performed on or at the margins of the treated segment, with no restenosis ≥ 50% as documented by peak systolic velocity ratio ≥2.0 as assessed by duplex ultrasound (DUS).|12 Months|Intention-to-Treat (ITT)||percentage of participants|||Number
782875|NCT00814970|Primary|Major Adverse Event (MAE) Rate|Major Adverse Events (MAE) defined as device and/or procedure related death (or any death occurring post-procedure through Day 30), target limb loss and target lesion or target vessel revascularization.|12 Months|Intent-to-Treat Population||percentage of participants|||Number
782879|NCT00815035|Secondary|Incidence of All Serious Adverse Events During the Study|All serious adverse events during the blinded and open-label phases of the study were recorded and reported as a safety outcome.|61 months for those randomized to active peanut OIT and 73 months for those randomized to placebo for the initial 12 months of the study.|The initial 10-11 months of the study were blinded. After unblinding, subjects completing the blinded phase continued on open label peanut OIT for the duration of the study.||number of discrete SAE events|||Number
782880|NCT00815035|Secondary|The Percentage of Subjects Who Are Successfully Able to Escalate up to the 4000 mg Maximum Maintenance Dose of Peanut Protein OIT During the 60 Month Desensitization Phase of the Study|During the desensitization phase of the study, subjects under go an initial day escalation up to a maximum of 6 mg of peanut protein. They then undergo biweekly dose escalation over approximately 10 months up to a maximum dose of 4000 mg of peanut protein. This outcome reports the percentage of subjects that achieve this.|approximately 40 weeks (10 months)|Open label phase includes subjects initially randomized to placebo and then subsequently crossed over to open label treatment. Subjects initially randomized to Peanut OIT maintained their dose and did not re-escalate for the purposes of this outcome.||percentage of patients|||Number
782881|NCT00815035|Secondary|The Percentage of Subjects Who Tolerated the Initial-day Escalation to 6 mg of Peanut|The first day of peanut OIT dosing involved multiple increasing doses of peanut flour in what was called an initial escalation day up to a maximum dose of 6 mg of peanut protein. The secondary outcome measure assessed the percentage of subjects were successfully able to reach this 6 mg dose.|first day of peanut OIT dosing|Open label phase includes subjects initially randomized to placebo and then subsequently crossed over to open label treatment. Subjects initially randomized to Peanut OIT maintained their dose and did not repeat this 6 mg initial-day escalation.||percentage of participants|||Number
782882|NCT00815035|Secondary|The Percentage of Subjects Achieving Full Desensitization as Defined by a Negative DBPCFC After 60 Months of Peanut OIT Therapy.|Upon completion of 60 months of peanut OIT treatment, subjects underwent a double-blind placebo controlled food challenge (DBPCPFC) to assess desensitization. The secondary clinical efficacy outcome of the study was the percentage of peanut allergic subjects who completed a 5 gm peanut protein double-blind placebo controlled food challenge (DBPCPFC) without developing symptoms after completing peanut OIT therapy.|60 months for those randomized to active treatment and 72 months for those randomized to placebo for the initial 12 months of therapy|Subjects completing 60 months of OIT treatment and completing the DBPCFC on the last day of treatment were analyzed.||percentage of participants|||Number
782883|NCT00815035|Primary|Percentage of Subjects Achieving Tolerance as Defined by a Negative DBPCFC 4 Weeks After Discontinuation of Peanut OIT Therapy.|Upon completion of 60 months of peanut OIT treatment, subjects discontinued peanut OIT for 4 weeks. The primary clinical efficacy outcome of the study was the percentage of peanut allergic subjects who completed a 5 gm peanut protein double-blind placebo controlled food challenge (DBPCPFC) without developing symptoms 4 weeks after discontinuing peanut OIT.|61 months for those randomized to active treatment and 73 months for those randomized to placebo for the initial 12 months of therapy|Subjects completing 60 months of OIT treatment, then passing the DBPCFC on the last day of treatment, then completing the DBPCFC after 1 month off of treatment were analyzed.||percentage of participants|||Number
782884|NCT00815087|Secondary|Questionnaire of Life Quality||1 to 3 months||||||
782885|NCT00815087|Primary|The Change From Baseline and Cut Point VFSS in Velocity of Displacement of Hyoid Bone at 1 to 3 Months|A parameter of the VFSS assessment was velocity of displacement of hyoid bone on 5mL thin barium sulfate bolus, which was defined as the displacement divided by the duration. The outcome measure time frame was based on VFSS assessment with the range between one to three months due to subjects received 1 to 3 times per week. We will provide the mean time frame, which is 2 months.|Averaged 2 months|||cm/s||Standard Deviation|Mean
782886|NCT00815191|Primary|Intraoperative Distal Esophageal (Core) Temperature||at 1 hour|||°C||Standard Error|Mean
782887|NCT00815295|Secondary|Phase 2 - Mean Change From Baseline in Quality of Life - Functional Assessment of Cancer Therapy - Head and Neck (FACT-H&N)|The outcome measure is the mean change in the Trial Outcome Index (TOI) between baseline and each follow-up assessment measured by the FACT-H&N. The instrument consists of 39 items to assess physical (PWB), social and family (SWB), emotional (EWB), functional well-bing (FWB) and additional head and neck specific concerns (HNCS). Using a 5-point Likert type scale, responses to individual items range from 0 (not at all) to 4 (Very Much) with higher scores indicating better quality of life. The TOI is the sum of PWB (7 items), FWB (7 items) and HNCS scores (12 items). TOI ranges from 0 to 140.|5 years|QOL data were not consistently collected and can not be analyzed.|||||
782888|NCT00815295|Secondary|Median Progression-Free Survival (PFS)|Time in months from the start of study treatment to the date of first progression (PD) according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, or death due to any cause. Per RECIST, a PD is indicated when there is at least a 20% increase in the sum of the longest diameters from target lesions relative to the smallest sum recorded since treatment is initiated. Median PFS was estimated using a Kaplan-Meier curve, and is the time at which 50% of patients remain alive without disease progression.|5 years|||months||95% Confidence Interval|Number
782889|NCT00815295|Secondary|Median Survival|Time in months from the start of study treatment to date of death due to any cause. Median survival was estimated using a Kaplan-Meier curve and is the time point at which 50% of patients remain alive.|5 years|Patients assigned to receive 400 mg of Sorafenib within the phase I or II component of the study are included in the analysis. 4 patients who had a Cetuximab hypersensitivity reaction on day 1 and then terminated treatment are excluded from the analyses.||months||95% Confidence Interval|Number
782890|NCT00815295|Primary|Tumor Control Rate|The proportion of patients for whom the best overall response is complete response (CR), partial response (PR) or stable disease (SD). A CR occurs when all lesions disappear; whereas, a PR is indicated when there is at least a 30% decrease in the sum of the longest diameters (LD) of the target lesion. A PD (progressive disease) occurs when there is at least a 20% increase in the sum of the LD relative to the smallest sum LD recorded since treatment is initiated. Disease is considered stable if there is no response and no PD. If follow-up assessments are not available, the best overall response is unevaluable.|1 year|Patients assigned to receive 400 mg of Sorafenib within the phase I or II component of the study are included in the analysis. 4 patients who had a Cetuximab hypersensitivity reaction on day 1 and then terminated treatment are excluded from the analyses.||percentage of participants||95% Confidence Interval|Number
782891|NCT00815295|Primary|Phase 1 - Maximum Tolerated Dose (MTD) of Sorafenib Administered With Cetuximab (400 mg/m2 Loading Dose Followed by 250 mg/m2 Weekly)|The MTD is based upon dose-limiting (DLTs) experienced during Cycle 1 of treatment. The MTD is the maximum dose level at which 0/6 or 1/6 patients experience DLT. Using Common Toxicity Criteria for Adverse EVents (CTCAE) version 3.0, DLTs are defined as any Grade 4 hematologic toxicity, or Grade 3 or 4 non-hematologic toxicity. A DLT will not be considered to have occurred in the case of a grade 3 or 4 allergic reaction due to cetuximab.|Cycle 1 (28 Days)|All patients treated on either dose level 1 or 2 as part of the phase I study.||mg|||Number
782892|NCT00815308|Secondary|Number of Participants With K-ras Gene Mutation|DNA was extracted from tumor specimens.Screened for the presence of KRAS codon 12 and 13 mutations using a PCR clamping and melting curve technique. PCR amplification of the wild-type KRAS sequence was suppressed in this process by the incorporation in the reaction mix of a locked nucleic-acid oligomer16 spanning codons 12 and 13 of the KRAS gene. Post-PCR hybridization and melting curve analysis using fluorescently tagged oligonucleotides incorporated in the original PCR reaction permitted the identification and discrimination of distinct KRAS codon 12 and 13 missense mutations.|07/29/2010-09/30/2010|||participants|||Number
782893|NCT00815308|Secondary|Participants With Progression Free Survival (PFS)||Recurrence or metastasis from the date of diagnosis||08/2013||||
782894|NCT00815308|Secondary|Participants With Overall Survival (OS) at 3 Year||3 year from the date of diagnosis||08/2013||||
782895|NCT00815308|Secondary|Participants With Overall Survival (OS) at 1 Year||1 year from the date of diagnosis||08/2011||||
782896|NCT00815308|Secondary|Number of Participants With Toxicity|All patients were regularly monitored for possible adverse events, which were graded according to National Cancer Institute Common Toxicity Criteria version 3.0.|Every week during treatment and 1 month after therapy|||participants|||Number
782897|NCT00815308|Primary|Number of Participants With Overall Response Rate (RR)|The overall response rate was defined as the numbers of patients with a complete response (CR) or partial response (PR). CR was defined as no target lesion at follow-up computed tomography scan and barium swallow examination 3–6 weeks after completion of chemo-radiation. PR was defined at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|1 to 3 month after therapy|||participants|||Number
782898|NCT00815347|Secondary|Asthma Control Test Questionnaire|Patient reported outcome minimum 5 (no symptoms) maximum 25 (severe symptoms)|end of each dosing period|||scores on a scale||Standard Deviation|Mean
782899|NCT00815347|Other Pre-specified|Ability to Taper Systemic Steroids Among Those Patients Who Are on Systemic Steroids at Study Entry.||17 weeks||||||
782900|NCT00815347|Other Pre-specified|Requirement for Urgent Medical Care for Asthma.||17 weeks||||||
782901|NCT00815347|Other Pre-specified|Requirement for Escalation of Controller Medication.||17 weeks||||||
782902|NCT00815347|Secondary|Rescue Beta-agonist||end of each dosing period|||puffs of rescue inhaler||Standard Deviation|Mean
782903|NCT00815347|Secondary|FEV1||end of dosing period|||liters||Standard Deviation|Mean
782904|NCT00815347|Primary|Symptom Scores|Symptom score could range from a minimum of 7 (no symptoms) to 35 (severe symptoms)|Last 7 days of each dosing period|||score on a scale||Standard Deviation|Mean
782905|NCT00815347|Primary|Peak Flow||last 7 days of each dosing period|Data not analyzed, study terminated early|||||
782906|NCT00815347|Primary|Change in FEV1||1, 2, 4 hours after dosing|||liters||95% Confidence Interval|Mean
782907|NCT00815360|Secondary|Mean Central Foveal Thickness (CFT) on Optical Coherence Tomography (OCT) in Microns at 6 Months||6 months|||units on a scale (microns)|Participants|95% Confidence Interval|Mean
782908|NCT00815360|Primary|Mean Change in Best Corrected Visual Acuity (BCVA), as Assessed by the Number of Letters Read Correctly on the ETDRS Eye Chart at a Starting Test Distance of 4 Meters From Baseline to Month 6.||6 months|We included 30 treatment-naïve eyes of 22 patients (8 bilateral patients) aged ≥ 18 years of age, with Type 1 or 2 diabetes mellitus and visual impairment secondary to diabetic macular edema associated with peripheral nonperfusion on UWFA.||Letters of visual acuity on ETDRS chart|Participants|95% Confidence Interval|Mean
782909|NCT00815490|Primary|Accuracy of Sensor|A scatterplot is created with the forehead sensor saturation on the y-axis and the measured blood saturation on the x-axis. The line of identity is drawn representing the ideal points, meaning that the forehead sensor saturation is always the same as the blood saturation. The dispersion of the actual data points around this line of identity can be measured using a statistical calculation called Arithmetic Root Mean Square or ARMS. The smaller the ARMS the closer the data points lie around the line of identity, representing a more accurate sensor.|Data collected from individual participants over 1 hour timeframe. Data from cohort of subjects collected over 6 month period.|Multiple data points from each individual were pooled and presented as group data.||percentage saturation||Full Range|Mean
782910|NCT00815516|Secondary|Plasma Micafungin Concentration||15 minutes post intravenous infusion (IV), 4-8 hours post IV and 15-24 hours post IV|The pharmacokinetics (PK) analysis set, including those infants who received any amount of study drug, have at least one study drug concentration, and have dosing and blood collection date and time data sufficient for inclusion in a population pharmacokinetic analysis.||ng/mL||Standard Deviation|Mean
782911|NCT00815516|Secondary|Follow-up Status for Infants With End-organ Assessments|"End-organ dissemination was assessed through abdominal ultrasound and/or computed tomography (CT), echocardiogram, head imaging and retinal exam. Each specific finding, documented by 1 of these techniques, was evaluated as follows:
Improvement: Improvement in size, number or density of identified lesions. Complete response was not expected but may have been documented.
Stabilization: Minor improvement or no change in size, number or density of identified lesions.
Worsening: Increase in size or number of identified lesions."|Baseline and 30 days after the last dose of study drug (maximum of 72 days)|Full analysis set participants with end-organ assessments||percentage of participants|||Number
782912|NCT00815516|Secondary|Mycological Response One Week After Last Dose of Study Drug|"Mycological response assessments were based on the following definitions and assessed by the DRP:
Eradication: Culture or histologically documented absence of the infecting Candida species from all positive normally sterile sites during therapy, documented by 2 negative samples, drawn at least 24 h apart; for Candida meningitis and/or candiduria, 1 negative culture.
Persistence: Continued isolation or histological documentation from a normally sterile site."|One week after the last dose of study drug (maximum of 49 days)|Full analysis set||percentage of participants|||Number
782913|NCT00815516|Secondary|Mycological Response at End of Study Drug Therapy|"Mycological response assessments were based on the following definitions and assessed by the DRP:
Eradication: Culture or histologically documented absence of the infecting Candida species from all positive normally sterile sites during therapy, documented by 2 negative samples, drawn at least 24 h apart; for Candida meningitis and/or candiduria, 1 negative culture.
Persistence: Continued isolation or histological documentation from a normally sterile site."|End of study drug therapy; maximum of 42 days|Full analysis set||percentage of participants|||Number
782914|NCT00815516|Secondary|Clinical Response One Week After Last Dose of Study Drug|"Clinical response assessments were based on the following definitions and assessed by the DRP:
Complete Response: Resolution of all attributable signs related to fungal infection, if present at baseline.
Partial Response: Improvement in attributable signs related to the fungal infection, if present at baseline.
Stabilization: Minor improvement or no change in attributable signs related to the fungal infection, if present at baseline, and infant continued on therapy without deterioration.
Progression: Deterioration in attributable signs related to the fungal infection, if present at baseline; or if death occurred presumably related to a fungal infection."|Baseline and one week after the last dose of study drug (maximum of 49 days)|Full analysis set participants with clinical signs and symptoms related to the fungal Infection at Baseline||percentage of participants|||Number
782915|NCT00815516|Secondary|Clinical Response at the End of Study Drug Therapy|"Clinical response assessments were based on the following definitions and assessed by the DRP:
Complete Response: Resolution of all attributable signs related to fungal infection, if present at baseline.
Partial Response: Improvement in attributable signs related to the fungal infection, if present at baseline.
Stabilization: Minor improvement or no change in attributable signs related to the fungal infection, if present at baseline, and infant continued on therapy without deterioration.
Progression: Deterioration in attributable signs related to the fungal infection, if present at baseline; or if death occurred presumably related to a fungal infection."|Baseline and end of study drug therapy; maximum of 42 days|Full analysis set participants with clinical signs and symptoms related to the fungal Infection at Baseline||percentage of participants|||Number
782916|NCT00815516|Secondary|Time to Positive Clinical Response|"Time to a positive clinical response is defined as the time from the first dose to the day during the treatment period that a positive clinical response (defined as a complete response or partial response) is observed for the first time, assessed by the Investigator.
Complete Response is defined as the resolution of all attributable signs related to fungal infection, if present at baseline and Partial Response is defined as improvement in attributable signs related to the fungal infection, if present at baseline.
Infants without positive responses and who survived were censored at one day post the end of treatment. Infants without positive responses who died before completing the treatment period, or were lost to follow-up during the treatment were censored at their death or last contact day."|From first dose up to 30 days after the last dose of study drug (maximum of 72 days)|Full analysis set participants with clinical signs and symptoms related to the fungal Infection at Baseline||days||95% Confidence Interval|Median
782917|NCT00815516|Secondary|Percentage of Participants With Recurrent Fungal Infections|A recurrent infection is defined as a systemic fungal infection in an infant with eradication at the end of study drug therapy, who developed positive blood cultures or a mycologically confirmed deep-seated Candida infection, with the same species as the enrolling infection.|Up to 30 days after the last dose of study drug (maximum of 72 days)|Participants in the full analysis set with eradication at the end of study drug therapy.||percentage of participants||95% Confidence Interval|Number
782918|NCT00815516|Secondary|Percentage of Participants With Emergent Fungal Infections|"An emergent fungal infection is defined as
An invasive fungal infection which is detected at any time during the study that is a non-Candida organism, or
An invasive fungal infection which is detected during the treatment or post-treatment period with a Candida species identified other than those detected at Baseline. If this occurred within 96 hours of the first dose of study drug, the infection was considered part of the final diagnosis of enrolling infection and not an emergent infection."|Up to 30 days after the last dose of study drug (maximum of 72 days)|Full analysis set||percentage of participants||95% Confidence Interval|Number
782919|NCT00815516|Secondary|Fungal-free Survival One Week After Last Dose of Study Drug in Infants With End-organ Dissemination|Fungal-free survival was assessed by an independent data review panel (DRP). Fungal-free survival is defined as the percentage of participants alive one week after last dose of study drug with a mycological response of eradication based upon the DRP assessment and no requirement for alternative systemic antifungal therapy for continued treatment.|One week after the last dose of study drug (maximum of 49 days)|Participants in the full analysis set with end-organ dissemination||percentage of participants||95% Confidence Interval|Number
782920|NCT00815516|Secondary|Fungal-free Survival at End of Study Drug Therapy in Infants With End-organ Dissemination|Fungal-free survival was assessed by an independent data review panel (DRP). Fungal-free survival is defined as the percentage of participants alive at the end of study drug therapy with a mycological response of eradication based upon the DRP assessment and no requirement for alternative systemic antifungal therapy for continued treatment.|The end of study drug therapy; maximum of 42 days|Participants in the full analysis set with end-organ dissemination||percentage of participants||95% Confidence Interval|Number
782921|NCT00815516|Secondary|Time to Mycological Clearance of Invasive Candidiasis|"Time to mycological clearance of invasive candidiasis is defined as the time from first dose to the day of mycological eradication for baseline invasive candidiasis infection.
Eradication was defined as a culture or histologically documented absence of the infecting Candida species from all positive normally sterile sites during therapy, documented by 2 negative samples, drawn at least 24 hours apart, or for for Candida meningitis and/or candiduria, 1 negative culture.
Infants without eradication during the treatment period and who survived were censored at one day after the end of treatment. Infants without eradication who died before completing the treatment period or were lost to follow-up during the treatment were censored at their death or last contact day."|From first dose up to 30 days after the last dose of study drug (maximum of 72 days)|Full analysis set||days||95% Confidence Interval|Median
782952|NCT00815659|Primary|Number of Patients Who Reached Target Level of Non-HDL-cholesterol After 3 Months of Rosuvastatin Treatment|Number of patients who reached target level of non-HDL-cholesterol after 3 months of rosuvastatin treatment|3 months (from enrollment to last visit)|Non-HDL cholesterol target levels <130 mg/dL, calculated over patients with lipid measurement performed at both visits||Participants|||Number
782922|NCT00815516|Primary|Fungal-free Survival|"Fungal-free survival was assessed by an independent data review panel (DRP). Fungal-free survival is defined as the percentage of participants alive at one week following the last dose of study drug with a mycological response of eradication and no requirement for alternative systemic antifungal therapy for continued treatment.
Eradication was defined as culture or histologically documented absence of the infecting Candida species from all positive normally sterile sites during therapy, documented by 2 negative samples, drawn at least 24 hours apart, or for Candida meningitis and/or candiduria, 1 negative culture."|One week after the last dose of study drug (maximum of 49 days)|Full Analysis Set (all randomized infants who were administered any amount of study drug)||percentage of participants||95% Confidence Interval|Number
782923|NCT00815659|Secondary|Number of Patients With Adverse Events|Number of patients with any adverse events in 3 months of rosuvastatin treatment|3 months (from enrollment to last visit)|Number of patients with any adverse events in 3 months||Participants|||Number
782924|NCT00815659|Secondary|Small HDL Subfraction Level After 3 Months of Rosuvastatin Treatment|Small HDL subfraction levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF (Last Observation Carried Forward) Small HDL subfraction levels of participants||mg/mL||Standard Deviation|Mean
782925|NCT00815659|Secondary|Basal Small HDL Subfraction Level|Small HDL subfraction levels before (Visit 2-enrollment)|Baseline|Baseline Small HDL subfraction of participants||mg/mL||Standard Deviation|Mean
782926|NCT00815659|Secondary|Intermediate HDL Subfraction Level After 3 Months of Rosuvastatin Treatment|Intermediate HDL subfraction levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF (Last Observation Carried Forward) Intermediate HDL subfraction levels of participants||mg/mL||Standard Deviation|Mean
782927|NCT00815659|Secondary|Basal Intermediate HDL Subfraction Level|Intermediate HDL subfraction levels before (Visit 2-enrollment)|Baseline|Baseline Intermediate HDL subfraction of participants||mg/mL||Standard Deviation|Mean
782928|NCT00815659|Secondary|Large HDL Subfraction Level After 3 Months of Rosuvastatin Treatment|Large HDL subfraction levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF (Last Observation Carried Forward) Large HDL subfraction levels of participants||mg/mL||Standard Deviation|Mean
782929|NCT00815659|Secondary|Basal Large HDL Subfraction Level|Large HDL subfraction levels before (Visit 2-enrollment)|Baseline|Baseline Large HDL subfraction of participants||mg/mL||Standard Deviation|Mean
782930|NCT00815659|Secondary|LDL-7 Level After 3 Months of Rosuvastatin Treatment|LDL-7 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF (Last Observation Carried Forward) LDL-7 levels of participants||mg/mL||Standard Deviation|Mean
782931|NCT00815659|Secondary|Basal LDL-7 Level|LDL-7 levels before (Visit 2-enrollment)|Baseline|Baseline LDL-7 levels of participants||mg/mL||Standard Deviation|Mean
782932|NCT00815659|Secondary|LDL-6 Level After 3 Months of Rosuvastatin Treatment|LDL-6 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF (Last Observation Carried Forward) LDL-6 levels of participants||mg/mL||Standard Deviation|Mean
782933|NCT00815659|Secondary|Basal LDL-6 Level|LDL-6 levels before (Visit 2-enrollment)|Baseline|Baseline LDL-6 levels of participants||mg/mL||Standard Deviation|Mean
782934|NCT00815659|Secondary|LDL-5 Level After 3 Months of Rosuvastatin Treatment|LDL-5 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF (Last Observation Carried Forward) LDL-5 levels of participants||mg/mL||Standard Deviation|Mean
782935|NCT00815659|Secondary|Basal LDL-5 Level|LDL-5 levels before (Visit 2-enrollment)|Baseline|Baseline LDL-5 levels of participants||mg/mL||Standard Deviation|Mean
782936|NCT00815659|Secondary|LDL-4 Level After 3 Months of Rosuvastatin Treatment|LDL-4 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF(Last Observation Carried Forward) LDL-4 levels of participants||mg/mL||Standard Deviation|Mean
782937|NCT00815659|Secondary|Basal LDL-4 Level|LDL-4 levels before (Visit 2-enrollment)|Baseline|Baseline LDL-4 levels of participants||mg/mL||Standard Deviation|Mean
782938|NCT00815659|Secondary|LDL-3 Level After 3 Months of Rosuvastatin Treatment|LDL-3 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF (Last Observation Carried Forward) LDL-3 levels of participants||mg/mL||Standard Deviation|Mean
782939|NCT00815659|Secondary|Basal LDL-3 Level|LDL subfractions are light (LDL1 and 2), intermediate (LDL3) and small dense LDL (LDL 4, 5, 6 and 7). Small dense LDL (sdLDL)-cholesterol that expresses greater atherogenicity than large buoyant LDL. Large LDL particles are the least likely to cause plaque formation, because LDL particles have to be approximately 25 nm in diameter or smaller to penetrate the artery walls. High sdLDL and decreased large HDL fraction are more common in patients with coronary heart disease than in controls|Baseline|Baseline LDL-3 levels of participants||mg/mL||Standard Deviation|Mean
782940|NCT00815659|Secondary|High Sensitivity C-reactive Protein (Hs-CRP) Level After 3 Months of Rosuvastatin Treatment|hs-CRP levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF (Last Observation Carried Forward) High Sensitivity C-reactive protein (Hs-CRP) levels of participants||mg/mL||Standard Deviation|Mean
782941|NCT00815659|Secondary|Basal High Sensitivity C-reactive Protein (Hs-CRP) Level|hs-CRP levels before (Visit 2-enrollment)|Baseline|Baseline High Sensitivity C-reactive protein (Hs-CRP) levels of participants||mg/mL||Standard Deviation|Mean
782942|NCT00815659|Secondary|Tumor Necrosis Factor (TNF) Level After 3 Months of Rosuvastatin Treatment|TNF levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF (Last Observation Carried Forward) Tumor Necrosis Factor (TNF) levels of participants||pg/mL||Standard Deviation|Mean
782943|NCT00815659|Secondary|Basal Tumor Necrosis Factor (TNF) Level|TNF levels before (Visit 2-enrollment)|Baseline|Baseline Basal Tumor Necrosis Factor (TNF) levels of participants||pg/mL||Standard Deviation|Mean
782944|NCT00815659|Secondary|Interleukin 10 (IL-10) Level After 3 Months of Rosuvastatin Treatment|IL-10 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF (Last Observation Carried Forward) IL-10 levels of participants||pg/mL||Standard Deviation|Mean
782953|NCT00815659|Primary|Number of Patients Who Reached Target Level of HDL-cholesterol After 3 Months of Rosuvastatin Treatment|Number of patients who reached target level of HDL-cholesterol after 3 months of rosuvastatin treatment|3 months (from enrollment to last visit)|HDL cholesterol target levels for males >40 mg/dL, for females > 50 mg/dL, calculated over patients with lipid measurement performed at both visits||Participants|||Number
782954|NCT00815659|Primary|Number of Patients Who Reached Target Level of LDL-cholesterol After 3 Months of Rosuvastatin Treatment|Number of patients who reached target level of LDL-cholesterol after 3 months of rosuvastatin treatment. Target level: LDL-cholesterol: <100 mg/dL; HDL-cholesterol: For males >40 mg/dL, for females >50 mg/dL; non-HDL-cholesterol: <130 mg/dL|3 months (from enrollment to last visit)|LDL cholesterol levels < 100 mg/dL, calculated over patients with lipid measurement performed at both visits||Participants|||Number
782955|NCT00815659|Primary|Triglyceride Level After 3 Months of Rosuvastatin Treatment|Triglycerides after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF (Last Observation Carried Forward) triglyceride levels of participants||mg/dL||Standard Deviation|Mean
782956|NCT00815659|Primary|Basal Triglyceride Level|Triglyceride levels before (mean of visit 1 - screening and Visit 2 - enrollment)|Baseline|Baseline triglyceride levels of participants||mg/dL||Standard Deviation|Mean
782957|NCT00815659|Primary|Total Cholesterol Level After 3 Months of Rosuvastatin Treatment|Total cholesterol after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF (Last Observation Carried Forward) total cholesterol levels of participants||mg/dL||Standard Deviation|Mean
782958|NCT00815659|Primary|Basal Total Cholesterol Level|Baseline|Total cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment)|Baseline total cholesterol levels of participants||mg/dL||Standard Deviation|Mean
782959|NCT00815659|Primary|LDL-cholesterol Level After 3 Months of Rosuvastatin Treatment|LDL- cholesterol levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF (Last Observation Carried Forward) LDL levels of participants||mg/dL||Standard Deviation|Mean
782960|NCT00815659|Primary|Basal LDL-cholesterol Level|LDL-cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment)|Baseline|Baseline LDL levels of participants||mg/dL||Standard Deviation|Mean
782961|NCT00815659|Primary|HDL-cholesterol Level After 3 Months of Rosuvastatin Treatment|HDL- cholesterol levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF (Last Observation Carried Forward) HDL levels of participants||mg/dL||Standard Deviation|Mean
782962|NCT00815659|Primary|Basal HDL-cholesterol Level|HDL-cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment)|Baseline|||mg/dL||Standard Deviation|Mean
782963|NCT00815685|Secondary|Number of Participants With Proteasome Activity That Was Inhibited in the Range of 6%-29%.|There is no expected range for “normal” activity since there is not currently a clinical indication for these molecular markers. Comparison of ranges can be made between groups (such as those that received treatment and not). This was an exploration of potential in the pilot study and further research is indicated to better understand the metabolic abnormalities observed in cancer cachexia as well as potential benefits of using agents such as EPA.|6 weeks per patient|Participants with available pre and post-treatment serum samples.||Participants|||Number
782964|NCT00815685|Primary|Change in Serum Albumin|Change in protein status at 6 weeks after initial diagnosis of weight loss of >5% body weight as indicated by morphological, biochemical and immunological intermediate biomarkers.|6 weeks per patient|||g/dL||Full Range|Median
782965|NCT00815698|Secondary|Recurrence|recurrence means recurrence of the hernia defined as a new lump in the inguinal region diagnosed by a surgeon to be a new inguinal hernia.|12 months after surgery|||participants|||Number
782966|NCT00815698|Primary|Pain, Numbness and Discomfort in the Groin|The primary endpoint was a combined measure that evaluated the prevalence of symptoms considered moderate or severe. These symptoms included moderate to severe chronic pain and/or numbness and/or groin discomfort at the 12-month visit.|12 months after surgery|||participants|||Number
782967|NCT00815776|Secondary|Change From Baseline In Craniomandibular Index (CMI) Scores At 3 Months (In A Scale)|The Craniomandibular Index (CMI) is designed to provide a basis for evaluating the severity of Temporomandibular Disorder (TMD) signs and symptoms. The assessment involves asking questions related to the condition of Mandibular Movement, TMJ noise, and palpations of the extraoral muscle, neck muscle, TMJ capsule and intraoral muscle. The answers to all of the questions are combined to calculate a score from 0 to 1 in which 0 represents no TMD signs and symptoms and 1 represents the most severe TMD signs and symptoms.|Change from Baseline in Craniomandibular Index (CMI) Score at Three Months Post-Baseline (in a scale)|"The arm that includes 0 (Mouth Splint Group) is included in the Primary Outcome Measure."||Units on a scale||Standard Deviation|Mean
782968|NCT00815776|Primary|Number of Subjects With Adverse Events|Subjects were assessed for adverse events from the baseline visit through study completion (3 months post-baseline). Adverse events were categorized by the investigator for severity and relationship to treatment.|From Baseline through 3 months post-baseline visit.|||Participants|||Number
782969|NCT00815776|Primary|Change From Baseline In Craniomandibular Index (CMI) Scores At 3 Months (In A Scale)|The Craniomandibular Index (CMI) is designed to provide a basis for evaluating the severity of Temporomandibular Disorder (TMD) signs and symptoms. The assessment involves asking questions related to the condition of Mandibular Movement, TMJ noise, and palpations of the extraoral muscle, neck muscle, TMJ capsule and intraoral muscle. The answers to all of the questions are combined to calculate a score from 0 to 1 in which 0 represents no TMD signs and symptoms and 1 represents the most severe TMD signs and symptoms.|Change from Baseline in Craniomandibular Index (CMI) Scores at 3 months (in a scale)|"The arm that includes 0 (Jaw Exercise) is reported in Seconary Outcome Measure Table."||Units on a scale||Standard Deviation|Mean
782970|NCT00815919|Secondary|Overall and cGVHD Progression-free Survival by 1 Year After Therapy||2 years|||percentage of participants||95% Confidence Interval|Number
782971|NCT00815919|Secondary|Proportion of cGVHD Patients Requiring Prednisone by 1 Year After Therapy|Participants who were still being followed 1 year after the start of therapy had their prednisone dose recorded.|1 year after the start of study treatment|Participants who were still being followed 1 year after the start of therapy.||participants|||Number
782972|NCT00815919|Secondary|The Toxicity of a 15 Week Course of Bortezomib Plus Prednisone in Patients With cGVHD|Participants' toxicities were graded based on the CTCAE version 3.0. The toxicities were then given an attribution to the velcade treatment: unrelated, unlikely, possible, probable, definite.|Toxicities were collected from the start of treatment through 15 weeks of therapy or end of study treatmetn|||participants|||Number
782973|NCT00815919|Secondary|Proportion of Patients Tolerating >50% Steroid Dose Reduction After a 15 Week Course of Bortezomib Plus Prednisone in Patients With cGVHD|The participants' total daily steroid dose was recorded at baseline and after a 15 week course of treatment. Starting at a dose of 0.5-1 mg/kg, dose reduction of steroids was permitted after 1 cycle of therapy. The suggested taper was 10-25% every 1-2 weeks. .|After 15 weeks of bortezomib plus prednisone therapy|Of the overall 22 patients, 18 patients completed 3 cycles (15 weeks) of therapy||participants|||Number
782974|NCT00815919|Primary|Overall Response Rate After a 15 Week Course of Bortezomib Plus Prednisone in Patients With cGVHD|"Participants had their cGVHD evaluated per NIH consensus criteria:
Complete response: resolution of all reversible manifestations of cGVHD.
Partial response: a decrease ≥ 1 point on a 3-point organ-specific scale or 2 points or more on a 10-point global scale without progression in any organ sites.
Stable disease: no evidence of cGVHD response without evidence of progressive cGVHD.
Progressive cGVHD: increase of ≥ 1 point on an organ-specific 3-point scale, addition of a new immunosuppressive agent prior to the completion of 15 weeks of combination therapy, or requirement an increase in the total daily dose of corticosteroids above a participant’s baseline corticosteroid dose during the 15-week combined treatment period.
Mixed response: a response in primary sites of cGVHD involvement but interval progressive cGVHD in other organs or sites.
Responses were not scored for oral or ocular cGVHD, since topical therapies were permitted during the study."|Patients had their cGVHD assessed at Baseline and at 15 weeks or end of therapy|||participants|||Number
782975|NCT00816023|Secondary|Treatment-emergent Adverse Events||Over the duration of the study.|Analysis conducted on Safety population, defined as all subjects randomized and received any study drug. Treatment groups are based on actual treatment received.||participants|||Number
782976|NCT00816023|Primary|Cumulative Volume of Packed Red Blood Cells Transfused at 12 Hours Post Surgery||Start of surgery up to 12 hours after the end of surgery|The Modified Intent to Treat population was the basis of this analysis, defined as all randomized subjects who received any amount of study drug and analyzed according to the planned treatment assignment.||mL||Standard Deviation|Mean
782977|NCT00816036|Secondary|Prescription of Recommended Pharmacotherapy for Smoking Cessation||Assessed within 72 hours of hospital discharge|||participants|||Number
782978|NCT00816036|Secondary|Referrals to Quitline||Assessed within 72 hours of hospital discharge|||participants|||Number
782979|NCT00816036|Primary|7-day Point-prevalence Smoking Abstinence (6-month)|This is the number of patients who reported not have smoked cigarettes over the 7 days prior to the 6-month follow-up interview.|6 months post enrollment|This is the total number of subjects who completed 6 month follow-up (complete case analysis).||participants|||Number
782980|NCT00816101|Secondary|Erythema at Week 3|"At each weekly follow up visit, wound erythema was evaluated by the clinician on a scale of 0-4, with 0 being No erythema, 1 being Very slight erythema, 2 being Well defined erythema, 3 being Moderate to severe erythema and 4 being Severe erythema to slight eschar formation"|3 Weeks|||Erythema Scores on a Scale||Standard Deviation|Mean
782981|NCT00816101|Secondary|Number of Patients Reporting Pain|Participants recorded their subjective pain level on a 0-10 Numeric Pain Chart 3x/day (0=no pain, 10=worst pain imaginable), until they had no pain for 3 consecutive days. Participants were also given a Patient Medication Log to complete at home to record RX and OTC medication they took to relieve pain. They were instructed to write the medication name, dosage, and amount of pills they took, as well as time taken, every day they took pain medication. Participants reporting pain had an associated score.|3 Weeks|||Participants|||Number
782982|NCT00816101|Primary|Number of Patients Who Experienced 50% or Greater Wound Healing|Participants were assessed to see whether or not the wound area was reduced by at least 50%, and the number of such participants is reported|3 Weeks|||Participants|||Number
782983|NCT00816166|Primary|Successful Outcome: No Stroke or Hard TIA in the Same Territory Within 12 Months|"The primary effectiveness endpoint was a composite of the two following outcomes:
Stroke in the same territory (distal to the target lesion) as the presenting event within 12 months of randomization
Hard Transient Ischemic Attack (TIA) in the same territory (distal to the target lesion) as the presenting event from day 2 through month 12 post-randomization
A subject was deemed to be a primary endpoint success if neither of these outcomes occurred.
The Kaplan-Meier success rate at 12-months post-operatively was calculated with Kaplan-Meier time-to-event methodology, where the time variable for patients who were successful (no stroke within 12 months or hard TIA between 2 days and 12 months) was censored at the time of last follow-up, and the time variable for patients who were not successful (had a stroke within 12 months or hard TIA between 2 days and 12 months) was censored at the time of the first event (stroke with 12 months or hard TIA between 2 days and 12 months)."|One Year|Analyses were based on an intent-to-treat (ITT) population, defined as enrolled subjects who met the inclusion/exclusion criteria and who were randomized post angiogram. Stent and Medical Therapy Group subjects were analyzed according to their ITT randomized group regardless of treatment received.||percent probability||95% Confidence Interval|Number
782984|NCT00816348|Primary|Level of Bilirubin|measurement of bilirubin level weekly. Available data reported.|week 2, 3,4,and 8|||mg/dL||Standard Deviation|Mean
782985|NCT00816400|Secondary|Overall Survival|Overall survival (OS) is defined as the time from the start of treatment with MEDI-575 until death. For the participants who were alive at the end of study or lost to follow-up, OS was censored on the last date when participants were known to be alive.|From the start of treatment with MEDI-575 until death or end of study, up to 33 months|Efficacy evaluable population. N= number of participants analyzed for this outcome measure||Months||95% Confidence Interval|Median
783024|NCT00816829|Primary|Apneas|Total number of episodes of apneas (i.e. cessation of breathing for at least 10 seconds) from central, obstructive or mixed origin during sleep during one night after one month of treatment|at one month of treatment|The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 on fenofibrate).||Number of apneas||Full Range|Median
785026|NCT00834639|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||µg*h/mL||Standard Deviation|Mean
782986|NCT00816400|Secondary|Progression-free Survival|Progression-free survival (PFS) is defined as time from the start of treatment with MEDI-575 until the documentation of disease progression or death due to any cause, whichever occurred first. Disease progression is defined according to RECIST guidelines (ie, at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions). PFS was censored on the date of last tumor assessment documenting absence of tumor progression for participants who have no documented progression and were still alive prior to data cutoff, dropout, or the initiation of alternate anticancer treatment. PFS was censored on the first date of treatment for the participants with no tumor assessments after the start of MEDI-575 treatment.|Start of treatment with MEDI-575 until the documentation of disease progression or death due to any cause whichever occurs first, up to 24 months|Efficacy evaluable population. N= number of participants analyzed for this outcome measure||Months||95% Confidence Interval|Median
782987|NCT00816400|Secondary|Time to Progression|Time to progression (TTP) is defined as time from the start of treatment with MEDI-575 until the documentation of disease progression. Disease progression is defined according to RECIST guidelines (ie, at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions). The TTP was censored on the date of last tumor assessment documenting absence of tumor progression for participants who have no documented progression prior to data cutoff, dropout, or the initiation of alternate anticancer treatment. TTP was censored on the first date of treatment for the participants with no tumor assessments after the start of MEDI-575 treatment.|Start of treatment with MEDI-575 until the documentation of disease progression, up to 24 months|Efficacy evaluable population. N= number of participants analyzed for this outcome measure||Months||95% Confidence Interval|Median
782988|NCT00816400|Secondary|Duration of Response|Duration of response is defined as the duration from the first documentation of objective response to the first documented disease progression. Disease progression is defined according to RECIST guidelines (ie, at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions). The duration of response was censored on the date of last tumor assessment documenting absence of disease progression for participants who have no documented progression prior to data cutoff, dropout, or the initiation of alternate anticancer treatment. Duration of response was calculated for the subgroup of participants with an objective response.||Efficacy evaluable population with an objective response. Duration of response was not estimable as there were no participants with an objective response.|||||
782989|NCT00816400|Secondary|Time to Response|Time to response was measured from the start of treatment with MEDI-575 to the first documentation of objective response (confirmed CR or PR). The time to response is assessed only for the participants who have achieved the objective response.||Efficacy evaluable population with an objective response. Time to response was not estimable as there were no participants with an objective response.|||||
782990|NCT00816400|Secondary|Percentage of Participants With Objective Response|Objective response rate is defined as the proportion of participants with confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. Confirmed responses are those that persist on repeat imaging study at least 4 weeks after the initial documentation of response. The CR is defined as disappearance of all target and non-target lesions, and normalization of tumor marker level. The PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|From study entry through the end of the study, up to 34 months|Efficacy evaluable population: All participants who have received any treatment of MEDI-575 and at least one tumor assessment after the initiation of MEDI-575.||Percentage of participants||95% Confidence Interval|Number
782991|NCT00816400|Secondary|Number of Participants Positive for Anti-drug Antibodies Formation for MEDI-575 at Any Visit|Blood samples for immunogenicity assessments were collected from participants prior to the initiation of infusion of each treatment cycle of MEDI-575. Anti-MEDI-575 antibodies were analyzed using the electro-chemiluminescence (ECL) based method. Only the number of participants positive for anti-MEDI-575 antibodies at any visit are presented.|Preinfusion on Cycle 1 Day 1 and 30 days after the last dose, up to 112 weeks|Safety population||Participants|||Number
782992|NCT00816400|Secondary|PK of MEDI-575 After the First Dose: Dose-normalized Area Under the Serum Concentration-time Curve (AUCτ/Dose)|The AUCτ/dose was obtained directly from the measured concentration-time curves. The concentration-time curve is the result of blood sampling at specified time points and its measured concentration of MEDI-575.|For 0.5/3, 6, 9, 12, 15 mg/kg: Cycle 1: Day 1 (pre- and end of infusion, 2 and 6 hours post infusion), Days 2, 3 and 8 (pre-dose); For 25 and 35 mg/kg: Cycle 1: Day 1 (pre- and end of infusion, 2 and 6 hours post infusion), Days 2, 3, 8 and 15.|All the participants who received first dose of MEDI-575 and from whom PK blood samples were collected and evaluated. Excluded participants were for whom it cannot be calculated (either number of doses received was less than 2 or standard deviation equals 0.000) or where dosing interval is more than 7 days or samples only collected up to 14 days.||μg·day/mL/mg||Standard Deviation|Mean
782993|NCT00816400|Secondary|PK of MEDI-575 After the First Dose: Area Under the Serum Concentration-time Curve Over the Dosing Interval (AUCτ)|The AUCτ was obtained directly from the measured concentration-time curves. The concentration-time curve is the result of blood sampling at specified time points and its measured concentration of MEDI-575.|For 0.5/3, 6, 9, 12, 15 mg/kg: Cycle 1: Day 1 (pre- and end of infusion, 2 and 6 hours post infusion), Days 2, 3 and 8 (pre-dose); For 25 and 35 mg/kg: Cycle 1: Day 1 (pre- and end of infusion, 2 and 6 hours post infusion), Days 2, 3, 8 and 15.|All the participants who received first dose of MEDI-575 and from whom PK blood samples were collected and evaluated. Excluded participants were for whom it cannot be calculated (either number of doses received was less than 2 or standard deviation equals 0.000) or where dosing interval is more than 7 days or samples only collected up to 14 days.||μg·day/mL||Standard Deviation|Mean
783025|NCT00816829|Primary|Sleep Time With Oxygen Saturation Below 90%|Percentage of Sleep time with oxygen saturation below 90% (measured by oximetry). Marker of consequences of apneas/hypopneas on arterial oxygenation during sleep during one night after one month of treatment. Higher percentage are worst for the patients.|at one month of treatment|The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 on fenofibrate).||Percentage of sleep time||Full Range|Median
782994|NCT00816400|Secondary|PK of MEDI-575 After the First Dose: Trough Serum Concentration (Ctrough)|The Ctrough ie, measured concentration at the end of a dosing interval (taken directly before next dose administration) of MEDI-575 was obtained directly from the measured concentration-time curves. The concentration-time curve is the result of blood sampling at specified time points and its measured concentration of MEDI-575.|For 0.5/3, 6, 9, 12, 15 mg/kg: Cycle 1: Day 1 (pre- and end of infusion, 2 and 6 hours post infusion), Days 2, 3 and 8 (pre-dose); For 25 and 35 mg/kg: Cycle 1: Day 1 (pre- and end of infusion, 2 and 6 hours post infusion), Days 2, 3, 8 and 15.|All the participants who received first dose of MEDI-575 and from whom PK blood samples were collected and evaluated. Excluded participants were for whom it cannot be calculated (either number of doses received was less than 2 or standard deviation equals 0.000) or where dosing interval is more than 7 days or samples only collected up to 14 days.||μg/mL||Standard Deviation|Mean
782995|NCT00816400|Secondary|PK of MEDI-575 After the First Dose: Dose-normalized Maximum Serum Concentration (Cmax/Dose)|The Cmax/dose after the first dose of MEDI-575 was obtained directly from the measured concentration-time curves. The concentration-time curve is the result of blood sampling at specified time points and its measured concentration of MEDI-575.|For 0.5/3, 6, 9, 12, 15 mg/kg: Cycle 1: Day 1 (pre- and end of infusion, 2 and 6 hours post infusion), Days 2, 3 and 8 (pre-dose); For 25 and 35 mg/kg: Cycle 1: Day 1 (pre- and end of infusion, 2 and 6 hours post infusion), Days 2, 3, 8 and 15.|All the participants who received first dose of MEDI-575 and for whom PK blood samples were collected and evaluated.||μg/mL/mg||Standard Deviation|Mean
782996|NCT00816400|Secondary|PK of MEDI-575 After the First Dose: Time to Maximum Concentration (Tmax)|The time to reach maximum serum concentration after the first dose of MEDI-575 was obtained directly from the measured concentration-time curves. The concentration-time curve is the result of blood sampling at specified time points and its measured concentration of MEDI-575.|For 0.5/3, 6, 9, 12, 15 mg/kg: Cycle 1: Day 1 (pre- and end of infusion, 2 and 6 hours post infusion), Days 2, 3 and 8 (pre-dose); For 25 and 35 mg/kg: Cycle 1: Day 1 (pre- and end of infusion, 2 and 6 hours post infusion), Days 2, 3, 8 and 15.|All the participants who received first dose of MEDI-575 and for whom PK blood samples were collected and evaluated.||Day||Standard Deviation|Mean
782997|NCT00816400|Secondary|Pharmacokinetics (PK) of MEDI-575 After the First Dose: Observed Maximum Serum Concentration (Cmax)|The concentration of MEDI-575 quantitatively determined in serum samples using a validated electrochemiluminescence (ECL) PK assay. The Cmax after the first dose was obtained directly from the measured concentration-time curves. The concentration-time curve is the result of blood sampling at specified time points and its measured concentration of MEDI-575.|For 0.5/3, 6, 9, 12, 15 mg/kg: Cycle 1: Day 1 (pre- and end of infusion, 2 and 6 hours post infusion), Days 2, 3 and 8 (pre-dose); For 25 and 35 mg/kg: Cycle 1: Day 1 (pre- and end of infusion, 2 and 6 hours post infusion), Days 2, 3, 8 and 15.|All the participants who received first dose of MEDI-575 and for whom PK blood samples were collected and evaluated.||Micrograms per milliliter (μg/mL)||Standard Deviation|Mean
782998|NCT00816400|Primary|Maximum Tolerated Dose (MTD)|For the dose escalation phase, a minimum of 21 evaluable participants (3 participants each in Dose Cohorts 1 through 7) were required for this study if Dose Limiting Toxicities (DLTs) do not occur. If a DLT does occur among the first 3 participants in a cohort, 3 additional participants were to be added to the cohort; 3 more participants were to be added to a cohort to determine the MTD if only 3 participants have been previously treated at that dose. The MTD is the maximum dose at which no more than 1 out of 6 participants experienced a DLT. A DLT is defined as any grade 3 or higher hematologic toxicity or any grade 3 or higher non-hematologic toxicity except grade 3 fever (in the absence of neutropenia) or grade 3 rigors/chills.|From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks|MTD evaluable population includes all participants in the dose escalation phase who have received at least 1 full cycle of MEDI-575 and have completed the safety follow-up through the DLT-evaluation period, or who experienced a DLT. The MTD dose was not evaluated as there were no DLTs reported in this study.||Milligrams per kilogram (mg/kg)|||Number
782999|NCT00816400|Primary|Treatment-emergent Adverse Events Related to Vital Sign Parameters|Vital signs (temperature, blood pressure, pulse rate, and respiratory rate) were performed throughout the study. The TEAEs related to vital signs in participants were reported.|From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks|Safety population||Participants|||Number
783000|NCT00816400|Primary|Treatment-emergent Adverse Events Related to Electrocardiogram Evaluations|All 12-lead electrocardiograms (ECGs) performed during the study were obtained in triplicate (ie, 3 ECGs were obtained within a 5-minute time interval) and analyzed. ECG parameters included heart rate (high and low), QT interval, QTcB (corrected QT interval per Bazett's formula), and QTcF (corrected QT interval per Fridericia's formula). Number of participants with TEAEs related to ECG after the start of study drug were reported.|From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks|Safety population||Participants|||Number
783001|NCT00816400|Primary|Treatment-emergent Adverse Events Related to Laboratory Parameters|Laboratory evaluations of blood and urine samples were performed, including hematology (complete blood count, differential, and platelet count); serum chemistry (SrChem) aspartate transaminase (AST), alanine transaminase, total bilirubin, creatinine, alkaline phosphatase, sodium, potassium, chloride, phosphorus, calcium, glucose, magnesium, albumin, and lactate dehydrogenase); and routine urinalysis. Number of participants with TEAEs related to laboratory evaluations were reported.|From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks|Safety population||Participants|||Number
783002|NCT00816400|Primary|Number of Participants With Serious Adverse Events|A serious AE (SAE) is any AE that results in death, is immediately life threatening, require (or prolong) inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event that may jeopardize the participant or may require medical intervention to prevent one of the outcomes listed above. Treatment-emergent SAEs that emerged after start of study drug were reported. Participants were counted only once for each event and by the highest event severity, regardless of how many events the participant experienced. The SAEs were summarized using MedDRA version 14.1.|From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks|Safety population||Participants|||Number
785027|NCT00834639|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||µg*h/mL||Standard Deviation|Mean
783003|NCT00816400|Primary|Number of Participants With Adverse Events|An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. Treatment-emergent AEs (TEAEs) are events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug, for the period extending to 30 days after the last dose of study drug. Participants were counted only once for each event and by the highest event severity, regardless of how many events the participant experienced. The AEs were summarized using Medical Dictionary for Regulatory Activities (MedDRA) version 14.1.|From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks|Safety population: All participants who have received any treatment of MEDI-575||Participants|||Number
783004|NCT00816556|Secondary|Change in Serum Estradiol (E2) Levels Between Baseline, 2 Weeks, and 12 Weeks||baseline, 2 weeks, 12 weeks|||pg/ml||Standard Deviation|Mean
783005|NCT00816556|Secondary|Change in Serum Estrone (E1) Levels Between Baseline, 2 Weeks, and 12 Weeks||baseline, 2 weeks, 12 weeks|||pg/ml||Standard Deviation|Mean
783006|NCT00816556|Primary|Change in Vulvovaginal Atrophy Questionnaire (VVAQ) Scores From Baseline to Week 12|The VVAQ consists of three questions asking the participant to rate the severity and how bothersome each of the symptoms of atrophic vaginitis are (dryness, itching, and burning). It is graded 0 through 10. A higher number indicates less severe and less bothersomeness of the symptom, that is, 0= very severe or bothersome, 10= least severe or bothersome.|baseline, 12 weeks|||units on a scale||Standard Deviation|Mean
783007|NCT00816595|Secondary|Progression-free Survival|The Kaplan-Meier method will be used to estimate progression-free survival distribution. Progression-free survival is defined as the time from registration to the time of progression or death, whichever occurs first.|Assessed up to 5 years from registration|One patient on Arm A was treated at an incorrect dose level and was not evaluable for this endpoint. On Arm B, one patient did not have correct eligibility reported, one patient did not complete an assessment, and one patient was incorrectly treated. The primary endpoint is based on 32 Arm A and 30 Arm B patients.||months||95% Confidence Interval|Median
783008|NCT00816595|Secondary|Overall Survival|The Kaplan-Meier method will be used to estimate overall survival distributions Overall survival is measured as the time from registration to the time of death due to any cause.|Assessed up to 5 years from registration|One patient on Arm A was treated at an incorrect dose level and was not evaluable for this endpoint. On Arm B, one patient did not have correct eligibility reported, one patient did not complete an assessment, and one patient was incorrectly treated. The primary endpoint is based on 32 Arm A and 30 Arm B patients.||months||95% Confidence Interval|Median
783009|NCT00816595|Primary|Complete and Overall Response Rate|"A Complete Response (CR) requires all of the following for 2 months:
Absence of lymphadenopathy by physical examination (PE)
No hepato- or splenomegaly by PE
Neutrophils >1500/ul, Platelets >100,000/ul. Hemoglobin >11.0 gm/dl, Peripheral blood lymphocytes <4000/uL
Nodular Partial Response (nPR) is defined as a patient qualified for a CR, but regenerative nodules are histologically present on bone marrow samples.
A Clinical Complete Response (CCR) is defined as a patient qualified for a CR, but bone marrow samples are not available.
A Partial Response (PR) requires 50% reduction in 2 of the following: peripheral blood lymphocytes, or the sum of the products of the maximal perpendicular diameters, or the size of liver and/or spleen; and a 50% increase in neutrophils, platelets, or hemoglobin.
Overall response rate is calculated as the number of patients receiving CR, CCR, nPR, or PR as their objective status divided by the total number of evaluable patients."|Evaluated after 6 cycles (up to 196 days)|One patient on Arm A was treated at an incorrect dose level and was not evaluable for this endpoint. On Arm B, one patient did not have correct eligibility reported, one patient did not complete an assessment, and one patient was incorrectly treated. The primary endpoint is based on 32 Arm A and 30 Arm B patients.||percentage of patients|||Number
783010|NCT00816777|Secondary|Overall Survival||1 year||||||
783011|NCT00816777|Secondary|Performance Status (ECOG)||1 year||||||
783012|NCT00816777|Secondary|Change in Tumor Marker||1 year||||||
783013|NCT00816777|Secondary|Hepatic Progression Free Survival||1 year||||||
783014|NCT00816777|Secondary|Local Tumor Response (Extent of Necrosis in the Treated Lesions)||1 year||||||
783015|NCT00816777|Secondary|Tumor Response (RECIST)||1 year||||||
783016|NCT00816777|Secondary|Toxicity, Adverse Events and Serious Adverse Events (NCI CTCAE v3.0)||6 weeks||||||
783017|NCT00816777|Primary|Progression Free Survival||1 year||||||
783018|NCT00816829|Primary|Index of Hypopneas|Average number of hypopneas per hour of sleep during one night after one month of treatment.|at one month of treatment|The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 on fenofibrate).||Number per hour of sleep||Full Range|Median
783019|NCT00816829|Primary|Index of Apneas|Average number of apneas per hour of sleep during one night after one month of treatment.|at one month of treatment|The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 on fenofibrate).||Number per hour of sleep||Full Range|Median
783020|NCT00816829|Primary|Central Apneas|Total number of central apneas (i.e. apneas with no respiratory effort present) during sleep during one night after one month of treatment.|at one month of treatment|The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 on fenofibrate).||Number of central apneas||Full Range|Median
783021|NCT00816829|Primary|Mixed Apneas|Total number of mixed apneas (i.e. sleep apneas that have both obstructive and central component) during sleep during one night after one month of treatment.|at one month of treatment|The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 on fenofibrate).||Number of mixed apneas||Full Range|Median
783022|NCT00816829|Primary|Index Apnea/Hypopnea|Average number of apneas and/or hypopneas per hour of sleep during one night after one month of treatment.|at one month of treatment|The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 on fenofibrate).||Number per hour of sleep||Full Range|Median
783023|NCT00816829|Primary|Hypopneas|Total number of episodes of hypopneas (i.e. 50% to 80% reduction in airflow with a decrease of 3-4% in arterial oxygen saturation) during sleep during one night after one month of treatment.|at one month of treatment|The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 on fenofibrate).||Number of hypopneas||Full Range|Median
783026|NCT00816829|Primary|Desaturations|Total number of desaturation events (i.e. defined as a decrease by 3 - 4% in oxygen saturation) during sleep during one night after one month of treatment.|at one month of treatment|The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 in fenofibrate).||Number of desaturations||Full Range|Median
783027|NCT00816829|Primary|Obstructive Apneas|Total number of obstructive apneas during sleep during one night after one month of treatment (i.e. an occlusion of the airways accompanied by ineffective respiratory efforts).|at one month of treatment|The analysis was performed using the total sample of randomized subjects (16 on placebo and 18 on fenofibrate).||Number of obstructive apneas||Full Range|Median
783028|NCT00816907|Secondary|Change in Hemoglobin A1c From Baseline to 16 Weeks|glycosylated hemoglobin|16 weeks|participants who took assigned treatment||percent||95% Confidence Interval|Least Squares Mean
783029|NCT00816907|Secondary|Change in Fasting Insulin From Baseline to 16 Weeks|Fasting insulin|16 weeks|participants who took assigned treatment||mU/L||95% Confidence Interval|Mean
783030|NCT00816907|Secondary|Change in Fasting Glucose From Baseline to 16 Weeks|fasting blood glucose|16 weeks|participants who took assigned treatment||mg/dL||95% Confidence Interval|Least Squares Mean
783031|NCT00816907|Secondary|Change in Triglycerides From Baseline to 16 Weeks|serum triglycerides|16 weeks|participants who took assigned treatment||mg/dL||95% Confidence Interval|Least Squares Mean
783032|NCT00816907|Secondary|Change in LDL Cholesterol From Baseline to 16 Weeks|low-density lipoprotein|16 weeks|participants who took assigned treatment||mg/dL||95% Confidence Interval|Least Squares Mean
783033|NCT00816907|Secondary|Change in HDL Cholesterol From Baseline to 16 Weeks|high-density lipoprotein|16 weeks|randomized participants who took assigned treatment||mg/dL||95% Confidence Interval|Least Squares Mean
783034|NCT00816907|Secondary|Change in Total Cholesterol From Baseline to 16 Weeks|Total cholesterol|16 weeks|randomized participants who took assigned treatment||mg/dL||95% Confidence Interval|Mean
783035|NCT00816907|Primary|Mean Difference in Body Weight Change Between Participants Assigned to Metformin and Participants Assigned to Placebo|Mean difference in body weight change between participants assigned to metformin and participants assigned to placebo from baseline to last study visit (up to 16 weeks)|Measured at the last study visit|Evaluable population that took assigned study treatment||kilograms||95% Confidence Interval|Mean
783036|NCT00798096|Secondary|Duration of Overall Response is the Time From First Documentation of Complete or Partial Response, Whichever Occurs Earlier, to Discontinuation of Study Drug.|Duration of Overall Response is the time from first documentation of Complete or Partial Response (Cheson 2007), whichever occurs earlier, to discontinuation of study drug.|Serial tumor assessments were taken at baseline (within 28 days of the start of treatment), and re-evaluated at Day 57, and every 8weeks therafter or to confirm response . (Maximum duration of treatment 182 days, Maximum duration of follow-up 217 days)|||Days||Standard Deviation|Median
783037|NCT00798096|Secondary|Overall Response Rate (ORR) is the Proportion of Patients With a Best Response of Complete Response (CR) or Partial Response (PR).|Overall response rate (ORR) is the proportion of patients with a best response of Complete Response (CR) or Partial Response (PR).|Serial tumor assessments were taken at baseline (within 28 days of the start of treatment), and re-evaluated at Day 57, and every 8weeks therafter or to confirm response . (Maximum duration of treatment 182 days, Maximum duration of follow-up 217 days)|||Participants|||Number
783038|NCT00798096|Secondary|Clinical Benefit Rate is the Proportion of Patients With Best Response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD).|Clinical benefit rate is the proportion of patients with best response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD).|Serial tumor assessments were taken at baseline (within 28 days of the start of treatment), and re-evaluated at Day 57, and every 8weeks therafter or to confirm response . (Maximum duration of treatment 182 days, Maximum duration of follow-up 217 days)|||Participants|||Number
783039|NCT00798096|Primary|The Primary Efficacy Endpoint for This Study is Overall Regressive Response Rate (ORRR): Proportion of Patients With a Best Response of Complete Response (CR), Partial Response (PR), or Regressive Stable Disease (RSD).|Overall regressive response rate (ORRR) is the proportion of patients with a best response of Complete Response (CR), Partial Response (PR) (per Cheson 2007), or Regressive Stable Disease (RSD) defined as regressive disease that does not meet the criteria for partial response.|Serial tumor assessments were taken at baseline (within 28 days of the start of treatment), and re-evaluated at Day 57, and every 8weeks therafter or to confirm response . (Maximum duration of treatment 182 days, Maximum duration of follow-up 217 days)|||Participants|||Number
783040|NCT00798135|Secondary|Time to Progression.|This is calculated as time till progression from treatment start until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months. If a patient did not progress, they were censored at the last evaluation visit. The median time till progression is calculated with its 95% confidence interval.|up to 100 months|All patients in the study.||Months||95% Confidence Interval|Median
783041|NCT00798135|Secondary|Number of Patients With Adverse Events Grade 3 or 4 That Are Related to Study Treatment|Number of patients with Adverse Events grade 3 or 4 that are related to study treatment. This will look into the safety of the study drug.|up to 100 months|All patients in the study.||Participants|||Number
783042|NCT00798135|Primary|Pharmacokinetics (PK) of Oral Itraconazole|To determine the pharmacokinetics (PK) of oral itraconazole in patients with MBC by measuring mean trough plasma levels at steady state at weeks 2 and 4.|pre-dose at Weeks 2 and 4|All patients with results available.||ng/mL||Standard Deviation|Mean
783043|NCT00798161|Secondary|Use of Rescue Therapy|The use of rescue therapy (SUs, thiazolidinediones [TZDs], or insulin) was permitted only during the randomised treatment period of the trial (i.e. Visits 3 to 7), and was to be administered only if a patient had a ‘confirmed’ glucose level after an overnight fast.|24 weeks|Percentage of patients requiring rescue therapy||percentage of participants|||Number
783044|NCT00798161|Secondary|FPG Change From Baseline at Week 24 for Open-label Patients|This change from baseline reflects the Week 24 FPG minus the baseline FPG. Mean is unadjusted.|Baseline and week 24|The open label set (OLS) included all patients with baseline HbA1c too high to be randomised and were assigned open-label medication, also with a baseline on treatment HbA1c value. The Open label Set (OLS) included all patients treated with at least one dose on open-label L2.5+M1000 medication.||mg/dL||Standard Deviation|Mean
783045|NCT00798161|Secondary|HbA1c Change From Baseline at Week 24 for Open-label Patients|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percentage. Mean is unadjusted.|Baseline and week 24|The open label set (OLS) included all patients with baseline HbA1c too high to be randomised and were assigned open-label medication, also with an on treatment HbA1c value. The Open label Set (OLS) included all patients treated with at least one dose on open-label L2.5+M1000 medication.||Percent||Standard Deviation|Mean
783046|NCT00798161|Secondary|Adjusted Means for 2h Post-Prandial Glucose (PPG) Change From Baseline at Week 24|This change from baseline reflects the Week 24 2h PPG minus the baseline 2h PPG. Means are treatment adjusted for baseline HbA1c, baseline 2h PPG and previous anti-diabetic medication.|Baseline and week 24|Meal tolerance test (MTT) set (patients with adequate MTT results available at the beginning and end of the randomised treatment period)||mg/dL||Standard Error|Mean
783047|NCT00798161|Secondary|Percentage of Patients With HbA1c Lowering by 0.5% at Week 24|The percentage of patients with an HbA1c reduction from baseline greater than 0.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c reduction less than 0.5%.|Baseline and week 24|The FAS included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Non-completers were considered as failure imputation (NCF).||percentage of patients|||Number
783048|NCT00798161|Secondary|Percentage of Patients With HbA1c < 6.5% at Week 24|The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 6.5%|Baseline and Week 24|The FAS included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Non-completers were considered as failure imputation (NCF).||percentage of patients|||Number
783049|NCT00798161|Secondary|Percentage of Patients With HbA1c <6.5% at Week 24|The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 6.5%. Only patients with baseline HbA1c =< 6.5%|Baseline and Week 24|FAS treated and randomised patients with baseline HbA1c >= 6.5%. Non-completers were considered as failure imputation (NCF).||percentage of patients|||Number
783050|NCT00798161|Secondary|Percentage of Patients With HbA1c<7.0 at Week 24|The percentage of patients with an HbA1c value below 7% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 7%.|Baseline and Week 24|The FAS included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Non-completers were considered as failure imputation (NCF).||percentage of patients|||Number
783051|NCT00798161|Secondary|Percentage of Patients With HbA1c <7.0% at Week 24|The percentage of patients with an HbA1c value below 7% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 7%.|Baseline and Week 24|FAS treated and randomised patients with baseline HbA1c >= 7.0%. Non-completers were considered as failure imputation (NCF).||percentage of patients|||Number
783052|NCT00798161|Secondary|FPG Change From Baseline at Week 18|This change from baseline reflects the Week 18 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 18|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.||mg/dL||Standard Error|Mean
783053|NCT00798161|Secondary|FPG Change From Baseline at Week 12|This change from baseline reflects the Week 12 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 12|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.||mg/dL||Standard Error|Mean
783054|NCT00798161|Secondary|FPG Change From Baseline at Week 6|This change from baseline reflects the Week 6 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 6|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.||mg/dL||Standard Error|Mean
783055|NCT00798161|Secondary|FPG Change From Baseline at Week 2|This change from baseline reflects the Week 2 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 2|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.||mg/dL||Standard Error|Mean
783056|NCT00798161|Secondary|FPG Change From Baseline at Week 24|This change from baseline reflects the Week 24 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 24|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.||mg/dL||Standard Error|Mean
783057|NCT00798161|Secondary|HbA1c Change From Baseline at Week 18|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 18|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||Percent||Standard Error|Mean
783058|NCT00798161|Secondary|HbA1c Change From Baseline at Week 12|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 12|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||Percent||Standard Error|Mean
783059|NCT00798161|Secondary|HbA1c Change From Baseline at Week 6|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 6 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 6|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||Percent||Standard Error|Mean
783060|NCT00798161|Primary|HbA1c Change From Baseline at Week 24|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 24|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||Percent||Standard Error|Mean
783061|NCT00798304|Primary|Percentage of Participants With at Least One Adverse Event (AE)||From signing of informed consent form to completion of study (up to 2 years)|||percentage of participants|||Number
783062|NCT00798304|Other Pre-specified|Serum Bactericidal Assay (SBA) GMTs for Additional MnB Test Strains||1 month after Dose 2, Dose 3; before Dose 4; 1, 6, 12, 18, 24, 36, 48 months after Dose 4|Results were not reported for this outcome measure because the study was terminated prior to the first scheduled post-vaccination blood draw and no immunogenicity data were collected.|||||
783063|NCT00798304|Other Pre-specified|Percentage of Participants Achieving SBA Titer Levels >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Additional MnB Test Strains||1 month after Dose 2, Dose 3; before Dose 4; 1, 6, 12, 18, 24, 36, 48 months after Dose 4|Results were not reported for this outcome measure because the study was terminated prior to the first scheduled post-vaccination blood draw and no immunogenicity data were collected.|||||
783064|NCT00798304|Other Pre-specified|Percentage of Participants Achieving Response >=1:4 for Additional Meningococcal Serogroup B (MnB) Test Strain-specific SBA Titer||1 month after Dose 2, Dose 3; before Dose 4; 1, 6, 12, 18, 24, 36, 48 months after Dose 4|Results were not reported for this outcome measure because the study was terminated prior to the first scheduled post-vaccination blood draw and no immunogenicity data were collected.|||||
783065|NCT00798304|Secondary|Percentage of Participants Achieving at Least 1:4, 1:8, 1:16, 1:32, 1:64, 1:128 rLP2086-specific SBA Titer to 1 Subfamily A Strain and 1 Subfamily B Strain||1 month after Dose 2, Dose 3; before Dose 4|Results were not reported for this outcome measure because the study was terminated prior to the first scheduled post-vaccination blood draw and no immunogenicity data were collected.|||||
783066|NCT00798304|Secondary|Serum Bactericidal Assay (SBA) Geometric Mean Titers (GMTs) for 1 Subfamily A Strain and 1 Subfamily B Strain||1 month after Dose 2, Dose 3; before Dose 4|Results were not reported for this outcome measure because the study was terminated prior to the first scheduled post-vaccination blood draw and no immunogenicity data were collected.|||||
783067|NCT00798304|Primary|Percentage of Participants Achieving at Least 1:4 rLP2086-specific Serum Bactericidal Assay (SBA) Titer to 1 Subfamily A Strain and 1 Subfamily B Strain||1 month after Dose 3|Results were not reported for this outcome measure because the study was terminated prior to the first scheduled post-vaccination blood draw and no immunogenicity data were collected.|||||
783068|NCT00798317|Secondary|Proportion of Subjects With Total Posterior Vitreous Detachment (PVD) at Day 28|Proportion of subjects with total PVD at Day 28, as determined by masked investigator assessment of B-scan ultrasound.|Day 28|Intention-To-Treat (ITT), Last Observation Carried Forward LOCF)||percentage of participants|||Number
783069|NCT00798317|Primary|Proportion of Subjects With Nonsurgical Resolution of Focal Vitreomacular Adhesion at Day 28|Proportion of subjects with nonsurgical resolution of focal vitreomacular adhesion at Day 28, as determined by masked Central Reading Centre (CRC) Optical Coherence Tomography(OCT)evaluation.|Day 28|Intention-To-Treat (ITT), Last Observation Carried Forward LOCF)||percentage of participants|||Number
783070|NCT00798369|Secondary|Amount of Rescue Medication Taken for Each Treatment Group|Participants who had difficulty in tolerating their pain after the 6-hour post-dose pain assessments and during the first 7 study days were allowed to take a maximum of 30 mg prednisolone (or equivalent dose of prednisone [30 mg]) orally once a day for a maximum of 5 days. In addition, participants could use 500 mg acetaminophen (paracetamol) and/or 30 mg codeine as needed during the first 7 study days. A maximum of 1 g/dose or 3 g/day of acetaminophen and 30 mg/dose or 180 mg/day of codeine was allowed during the first 7 days of the study.|7 days after study drug administration|The Full Analysis Set (FAS) consisted of all participants as randomized that had at least one post baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, participants were analyzed according to the treatment they were assigned to at randomization.||mg||Standard Deviation|Mean
783071|NCT00798369|Primary|The Dose of Canakinumab for Treatment of Acute Flares in Gout Patients That Leads to the Same Efficacy as Triamcinolone Acetonide With Respect to Pain Intensity on a 0-100 mm Visual Analog Scale (VAS)|Mean target dose at 24, 48 and 72 hours. Four models: Emax, Logistic, Linear in log-dose, Linear were selected to describe the potential dose-response curve and hence estimate the target dose of canakinumab using baseline Visual Analog Scale (VAS) and Body Mass Index (BMI) as covariates. Target dose was defined as the dose for which the efficacy is equivalent to the efficacy of triamcinolone acetonide 40 mg and was identified by assessing the dose response relationship with regards to the pain intensity in the target joint measured on a 0- 100 mm VAS (0= no pain and 100= unbearable pain).|at 24,48 and 72 hours post-baseline|The Full Analysis Set (FAS) consisted of all participants as randomized that had at least one post baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, participants were analyzed according to the treatment they were assigned to at randomization.||mg||95% Confidence Interval|Number
783072|NCT00798369|Secondary|Serum Amyloid Protein (SAA) Levels at 72 Hours, 7days, 4 Weeks and 8 Weeks Post Dose for Each Treatment Group|"Serum amyloid A (SAA) were determined in serum at all visits (Visits 1-5) in order to identify the presence of inflammation, to determine its severity, and to monitor response to treatment.
ANCOVA with treatment group, protein level at baseline and BMI at baseline as covariates."|at 72 hours and 7 days, 4 and 8 weeks post-dose|The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one post-baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.||mg/L||Standard Error|Least Squares Mean
783084|NCT00798434|Secondary|Change From Baseline in EQ-5D- Each Dimension Score at Week 12|EQ-5D: participant rated questionnaire to assess HRQL in terms of a single utility score. Health State Profile component assessed level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicated better health state; 3 indicated worst health state. Scoring formula assigned utility value for each domain in profile. Score was transformed and results in total score could have ranged from -0.594 to 1.000; Change = observation minus baseline, where higher scores indicated a better health state.|Baseline and Week 12|Not analyzed||Scores on a scale||Standard Deviation|Mean
783073|NCT00798369|Secondary|High Sensitivity C-reactive Protein (hsCRP) at 72 Hours, 7days, 4 Weeks and 8 Weeks Post Dose for Each Treatment Group|"High sensitivity C-reactive protein (hsCRP) was determined in serum at all visits (Visits 1-5) in order to identify the presence of inflammation, to determine its severity, and to monitor response to treatment.
ANCOVA with treatment group, protein level at baseline and BMI at baseline as covariates."|at 72 hours and 7 days, 4 and 8 weeks post-dose|The Full Analysis Set (FAS) consisted of all participants as randomized that had at least one post baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, participants were analyzed according to the treatment they were assigned to at randomization.||mg/L||Standard Error|Least Squares Mean
783074|NCT00798369|Secondary|The Time to 50% Reduction of Baseline Pain Intensity in the Target Joint|The median time in days to at least 50% reduction in Pain intensity from baseline as measured by Visual Analog Scale (VAS) for each treatment group. Participants scored their pain intensity in the target joint on a 0-100 mm VAS, ranging from no pain (0) to unbearable pain (100).|Baseline, within 7 days after randomization|The Full Analysis Set (FAS) consisted of all participants as randomized that had at least one post baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, participants were analyzed according to the treatment they were assigned to at randomization.||Days||95% Confidence Interval|Median
783075|NCT00798369|Secondary|Percentage of Participants With an Excellent or Good Response With Regards to the Patient's Global Assessment of Response to Treatment|Participants scored their global assessment of response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Slight and Poor.|at 72 hours post-baseline|The Full Analysis Set (FAS) consisted of all participants as randomized that had at least one post-baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, participants were analyzed according to the treatment they were assigned to at randomization.||Percentage of Participants|||Number
783076|NCT00798369|Secondary|The Change in Pain Intensity in the Target Joint Following Canakinumab Administration Compared to Triamcinolone Acetonide|The change in pain intensity from baseline to 72 hours and 7 days post dose as measured on a 0-100 mm Visual Analog Scale(VAS): 0= no pain and 100= severe pain. Analysis of Covariance (ANCOVA) with treatment group, VAS at baseline and Body mass Index (BMI) at baseline as covariates. Change from baseline = (post-baseline measurement – baseline).|Baseline,at 72 hrs post-dose and 7 days post-dose|Full Analysis Set consisting of all participants with data for baseline and the given time point for each arm/group. Assessments up to Day 8, with 1 missing pain intensity value had it imputed. LOCF method was applied to impute post-dose measurements. Missing baseline values were replaced by the median baseline assessment||Units on a scale||Standard Error|Least Squares Mean
783077|NCT00798434|Other Pre-specified|Change From Baseline in Mean Number of UUI Episodes Per 24 Hours at Week 24|UUI episodes defined as those with USS rating of 5 (unable to hold; leak urine) in the diary. Change = observation minus baseline, where lower scores were an improvement/decrease in UUI episodes.|Baseline and Week 24|FAS; N=participants with evaluable data.||Episodes per 24 hours||Full Range|Median
783078|NCT00798434|Other Pre-specified|Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 24|Micturitions include episodes of voluntary micturition and episodes of UUI. UUI episodes defined as those micturitions with USS rating of 5 (unable to hold; leak urine) in the diary in participants with UUI at baseline. Change = observation minus baseline, where lower scores were an improvement/decrease in micturitions.|Baseline and Week 24|FAS; N=participants with evaluable data.||Micturitions per 24 hours||Standard Deviation|Mean
783079|NCT00798434|Other Pre-specified|Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Week 24|Nocturnal micturitions were defined as micturitions with USS rating 1-5 that occurred between the time the participant went to bed and the time he or she arose to start the next day. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. Calculated as number of nocturnal micturitions divided by number of diary days collected at that visit. Change = observation minus baseline, where lower scores were an improvement/decrease in nocturnal micturitions.|Baseline and Week 24|FAS; N=participants with evaluable data.||Micturitions per 24 hours||Standard Deviation|Mean
783080|NCT00798434|Other Pre-specified|Change From Baseline in Mean Number of Severe Micturition-Related Urgency Episodes Per 24 Hours at Week 24|Severe micturition-related urgency episodes defined as those with the USS rating >=4. USS rating of 4: Severe feeling of urgency and 5: Unable to hold; leak urine. Change = observation minus baseline, where lower scores were an improvement/decrease in micturition-related urgency episodes.|Baseline and Week 24|FAS; N=participants with evaluable data.||Episodes per 24 hours||Standard Deviation|Mean
783081|NCT00798434|Other Pre-specified|Change From Baseline in Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 24|Number of micturition-related urgency episodes per 24 hours calculated as number of micturitions with USS rating of >=3 divided by number of days that diary data was collected at that visit. USS rating of 3: Moderate feeling of urgency, 4: Severe feeling of urgency, 5: Unable to hold; leak urine). Change = observation minus baseline, where lower scores were an improvement/decrease in micturition-related urgency episodes.|Baseline and Week 24|FAS; N=participants with evaluable data.||Episodes per 24 hours||Standard Deviation|Mean
783082|NCT00798434|Other Pre-specified|Percentage of Participants With Improvement at Week 24|Patient Treatment Benefit Scale (PTBS): single-item scale assessed fesoterodine efficacy and safety in participants with overactive bladder. Participants asked to compare their present condition with their condition before start of trial: “My condition has been: 1=Greatly Improved; 2=Improved; 3=Not Changed; 4=Worsened, During Treatment.” Treatment Response was set to “Yes” if the first 2 categories (1 or 2) of the scale selected and “No” if the last 2 categories (3 or 4) were selected. Improvement was defined as a rating of 1 or 2.|Pre-baseline and Week 24|Not analyzed||Percentage of participants|||Number
783083|NCT00798434|Secondary|Change From Baseline in Mini Mental State Examination (MMSE) at Week 12|MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranged from 0 - 30, higher score indicated better cognitive state. Change = observation minus baseline where higher scores indicated better cognitive functioning.|Baseline and Week 12|FAS||Scores on a scale||Standard Deviation|Mean
783143|NCT00798655|Primary|Probability of Progression-free Survival (PFS) at 2 Years||Up to 90 months for cohort; individual patients up to 24 months after study treatment|Patients who received 60-66 Gy over 6-7 weeks) concurrent with cisplatin 30 mg/m^2 and at least once dose of panitumumab 2.5 mg/kg.||percentage of participants||95% Confidence Interval|Number
783085|NCT00798434|Secondary|Change From Baseline in EQ-5D- Health State Profile Utility Score at Week 12|EQ-5D: participant rated questionnaire to assess HRQL in terms of single index value. Visual Analogue Scale (VAS) component rated current health state on scale from 0 (worst imaginable health state) to 100 (best imaginable health state). For each question, scores categorized into 3 levels of response, level 1=no health problems, 2=some problems and 3= extreme problems, and health state profile utility score derived from these, which could range from 1 prefect health to -0.594 worst possible health. Change = observation minus baseline, where higher scores indicated a better health state.|Baseline and Week 12|FAS; N=participants with evaluable data; n=participants with evaluable data a specified time point.||Scores on a scale||Standard Deviation|Mean
783086|NCT00798434|Secondary|Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12|KHQ: self-administered questionnaire contained 21 questions scored in 9 domains (general health perception, incontinence impact, role limitations, physical limitations, social limitations, personal relationships, emotions, sleep/energy, severity of urinary symptoms). Range: 0-100, where 0=best outcome/response and 100=worst outcome/response. Change = observation minus baseline, where lower scores indicated better outcome/response.|Baseline and Week 12|FAS; N=participants with evaluable data at sites in the United Kingdom only; n=participants with evaluable data for specific KHQ category. LOCF method used for statistical analyses of the FAS (change from baseline to Week 12).||Scores on a scale||Standard Deviation|Mean
783087|NCT00798434|Secondary|Change From Week 12 in OAB-S Scale for OAB Medication Expectation at Week 24|OAB-S: evaluated OAB medication expectations, daily life with OAB, and satisfaction with OAB medication. Included 3 stand-alone items that assessed overall expectation, satisfaction, and willingness to continue treatment. Medication expectation coded on scale 1=Greatly exceeds my expectations to 5=Does not meet my expectations at all. Coding reversed by subtracting initial response value from 6, so higher final response value associated with better fulfilment of OAB medication expectations.|Weeks 12 and 24|FAS; N=participants with evaluable data. LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12).||Scores on a scale||Standard Deviation|Mean
783088|NCT00798434|Secondary|Change From Week 12 in Overactive Bladder Satisfaction (OAB-S) Scale for Satisfaction With OAB Control at Week 24|OAB-S: validated self-administered instrument that evaluated OAB medication expectations, daily life with OAB, and satisfaction with OAB medication and included 3 stand-alone items that assessed overall expectation, satisfaction, and willingness to continue treatment. Satisfaction coded on scale of 1-5: (1-very satisfied to 5-very dissatisfied). Coding reversed algorithmically and results transformed: total score range 0-100. Higher final response value associated with better satisfaction. Change = score at Week 24 minus score at Week 12 where higher scores indicated better satisfaction.|Weeks 12 and 24|FAS; N=participants with evaluable data. LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12).||Scores on a scale||Standard Deviation|Mean
783089|NCT00798434|Secondary|Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24|OAB-q: self-administered, 33-item, questionnaire assessed how much participant bothered by bladder symptoms during previous week. Each item rated by participant on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Raw scores transformed to 0-100 score where higher scores were less favorable outcome. Questions 1-8 constituted symptom severity/bother score. Questions 9-33 constitute HRQL component, which included domains of coping, concern, sleep, and social function. Change = observation minus baseline and higher scores were an improvement.|Baseline and Weeks 4, 8, 12, and 24|FAS; N=participants with evaluable data; n=participants with evaluable data at specific time point. LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12). Change from baseline to Week 24 not analyzed.||Scores on a scale||Standard Deviation|Mean
783090|NCT00798434|Secondary|Change From Baseline in Overactive Bladder Satisfaction Questionnaire (OAB-q) Total Score at Weeks 4, 8, 12, and 24|OAB-q: self-administered, 33-item, questionnaire assessed how much participant was bothered by selected bladder symptoms during previous week. Each item rated by participant on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Raw scores transformed to a score from 0-100 where higher scores represented less favorable outcome. Change = observation minus baseline and higher scores were an improvement.|Baseline and Weeks 4, 8, 12, and 24|FAS; N=participants with evaluable data; n=participants with evaluable data at specific time point. LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12). Change from baseline to Week 24 not analyzed.||Scores on a scale||Standard Deviation|Mean
783091|NCT00798434|Secondary|Change From Baseline in Overactive Bladder Satisfaction Questionnaire (OAB-q) Symptom/Bother Score at Weeks 4, 8, 12, and 24|OAB-q: self-administered, 33-item, questionnaire assessed how much participant was bothered by selected bladder symptoms during previous week. Each item rated by participant on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Raw scores transformed to a score from 0-100 where higher scores represented less favorable outcome. Change = baseline minus observation and higher scores were an improvement.|Baseline and Weeks 4, 8, 12, and 24|FAS; N=participants with evaluable data; n=participants with evaluable data at specific time point. LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12). Change from baseline to Week 24 not analyzed.||Scores on a scale||Standard Deviation|Mean
783092|NCT00798434|Secondary|Change From Baseline in PPUS at Week 24|PPUS: self-administered, single-item, questionnaire that measured the participant’s perception of urinary urgency. It was sensitive to changes in perceptions of urinary urgency over time. Scale of 0 (usually not able to hold urine), 1 (usually able to hold urine [without leaking] until reaching toilet if go to toilet immediately), or 2 (usually able to finish what he/she was doing before going to toilet [without leaking]). Change = observation minus baseline. Improvement in PPUS defined as increase of 1 or more points in difference of scores relative to baseline.|Baseline and Week 24|Not analyzed||Participants|||Number
783093|NCT00798434|Secondary|Change From Baseline in PPUS at Week 12|PPUS: self-administered, single-item, questionnaire that measured the participant’s perception of urinary urgency. It was sensitive to changes in perceptions of urinary urgency over time. Scale of 0 (usually not able to hold urine), 1 (usually able to hold urine [without leaking] until reaching toilet if go to toilet immediately), or 2 (usually able to finish what he/she was doing before going to toilet [without leaking]). Change = observation minus baseline. Improvement in PPUS defined as increase of 1 or more points in difference of scores relative to baseline.|Baseline and Week 12|FAS; N=participants with evaluable data; LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12).||Participants|||Number
783094|NCT00798434|Secondary|Change From Baseline in PPUS at Week 8|PPUS: self-administered, single-item, questionnaire that measured the participant’s perception of urinary urgency. It was sensitive to changes in perceptions of urinary urgency over time. Scale of 0 (usually not able to hold urine), 1 (usually able to hold urine [without leaking] until reaching toilet if go to toilet immediately), or 2 (usually able to finish what he/she was doing before going to toilet [without leaking]). Change = observation minus baseline. Improvement in PPUS defined as increase of 1 or more points in difference of scores relative to baseline.|Baseline and Week 8|FAS; N=participants with evaluable data||Participants|||Number
783095|NCT00798434|Secondary|Change From Baseline Patient Perception of Urgency Scale (PPUS) at Week 4|PPUS: self-administered, single-item, questionnaire that measured the participant’s perception of urinary urgency. It was sensitive to changes in perceptions of urinary urgency over time. Scale of 0 (usually not able to hold urine), 1 (usually able to hold urine [without leaking] until reaching toilet if go to toilet immediately), or 2 (usually able to finish what he/she was doing before going to toilet [without leaking]). Change = observation minus baseline. Improvement in PPUS defined as increase of 1 or more points in difference of scores relative to baseline.|Baseline and Weeks 4|FAS; N=participants with evaluable data||Participants|||Number
783096|NCT00798434|Secondary|Change From Baseline in PPBC at Week 24|PPBC: self-administered, single-item, questionnaire that asked participants to describe their perception of their bladder-related problems. PPBC assessment rated on a 6-point scale: 1=no problems at all, 2=some very minor problems, 3=some minor problems, 4=moderate problems, 5=severe problems, 6=many severe problems. Change = observation minus baseline. Results categorized as Deterioration (score difference ≥1), No Change (score difference=0), Improvement (score difference <0).|Baseline and Week 24|Not analyzed||Participants|||Number
783097|NCT00798434|Secondary|Change From Baseline in PPBC at Week 12|PPBC: self-administered, single-item, questionnaire that asked participants to describe their perception of their bladder-related problems. PPBC assessment rated on a 6-point scale: 1=no problems at all, 2=some very minor problems, 3=some minor problems, 4=moderate problems, 5=severe problems, 6=many severe problems. Change = observation minus baseline. Results categorized as Deterioration (score difference ≥1), No Change (score difference=0), Improvement (score difference <0).|Baseline and Week 12|FAS; N=participants with evaluable data; LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12).||Participants|||Number
783098|NCT00798434|Secondary|Change From Baseline in PPBC at Week 8|PPBC: self-administered, single-item, questionnaire that asked participants to describe their perception of their bladder-related problems. PPBC assessment rated on a 6-point scale: 1=no problems at all, 2=some very minor problems, 3=some minor problems, 4=moderate problems, 5=severe problems, 6=many severe problems. Change = observation minus baseline. Results categorized as Deterioration (score difference ≥1), No Change (score difference=0), Improvement (score difference <0).|Baseline and Week 8|FAS; N=participants with evaluable data||Participants|||Number
783099|NCT00798434|Secondary|Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4|PPBC: self-administered, single-item, questionnaire that asked participants to describe their perception of their bladder-related problems. PPBC assessment rated on a 6-point scale: 1=no problems at all, 2=some very minor problems, 3=some minor problems, 4=moderate problems, 5=severe problems, 6=many severe problems. Change = observation minus baseline. Results categorized as Deterioration (score difference ≥1), No Change (score difference=0), Improvement (score difference less than [<]0).|Baseline and Week 4|FAS; N=participants with evaluable data||Participants|||Number
783100|NCT00798434|Secondary|Percentage of Participants With Improvement at Week 12|Patient Treatment Benefit Scale (PTBS): single-item scale assessed fesoterodine efficacy and safety in participants with overactive bladder. Participants asked to compare their present condition with their condition before start of trial: “My condition has been: 1=Greatly Improved; 2=Improved; 3=Not Changed; 4=Worsened, During Treatment.” Improvement was defined as a rating of 1 or 2.|Week 12|FAS; N=participants with evaluable data. LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12).||Percentage of participants|||Number
783101|NCT00798434|Secondary|Change From Baseline in Number of Skin Protective Agents Used by Participants at Weeks 4, 8, and 12|Skin protective agents included incontinence pads, barrier creams, and powders. Change = observation minus baseline, where lower scores were an improvement/decrease in protective skin agents used.|Baseline and Weeks 4, 8, and 12|FAS; N=participants with evaluable data; n=participants with evaluable data at specific time point. LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12).||Skin protective agents||Standard Deviation|Mean
783102|NCT00798434|Secondary|Percentage of Participants Who Were Incontinent at Baseline and Became Dry|Percentage of participants who had at least 1 UUI episode during baseline period and were dry (no UUI episodes) in the 3 days prior to study visits at week 8 and 12. UUI episodes defined as those with USS rating of 5 (unable to hold; leak urine) in the diary.|Weeks 8 to 12|FAS; N=number of participants with evaluable data. LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12).||Percentage of participants|||Number
783103|NCT00798434|Secondary|Change From Baseline in Daily Sum Rating in USS at Weeks 4, 8, and 12|USS total range 1 to 5 (1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine). Change = observation minus baseline, where lower scores were an improvement/decrease in urinary sensation.|Baseline and Weeks 4, 8, and 12|FAS; N=participants with evaluable data; n=participants with evaluable data at specific time point. LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12).||Scores on a scale||Standard Deviation|Mean
783104|NCT00798434|Secondary|Percent Change From Baseline of UUI Episodes Per 24 Hours at Weeks 4, 8, and 12|UUI episodes defined as those with the USS rating of 5 (unable to hold; leak urine)in the diary. Change = observation minus baseline, where lower scores were an improvement/decrease in UUI episodes.|Baseline and Weeks 4, 8, and 12|FAS; N=participants with evaluable data; n=participants with evaluable data at specific time point. LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12).||Percent change||Full Range|Median
783165|NCT00798889|Primary|Duration of Treatment||Baseline up to Day 28 after last dose of study treatment|The intent-to-treat population included all participants who were enrolled in the study and received at least 1 dose of study medication.||Days||Full Range|Median
783105|NCT00798434|Secondary|Change From Baseline in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 4, 8, and 12|UUI episodes defined as those with USS rating of 5 (unable to hold; leak urine) in the diary. Change = observation minus baseline, where lower scores were an improvement/decrease in UUI episodes.|Baseline and Weeks 4, 8, and 12|FAS; N=participants with evaluable data; n=participants with evaluable data at specific time point. LOCF method used for statistical analyses of the FAS (change from baseline to Week 12).||Episodes per 24 hours||Full Range|Median
783106|NCT00798434|Secondary|Percent Change From Baseline in Nocturnal Micturitions Per 24 Hours at Weeks 4, 8, and 12|Nocturnal micturitions defined as micturitions with USS rating 1-5 that occurred between time participant went to bed and time he or she arose to start the next day. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. Change = observation minus baseline, where lower scores were an improvement/decrease in nocturnal micturitions.|Baseline and Weeks 4, 8, and 12|FAS; n=participants with evaluable data at specific time point. LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12).||Percent change||Full Range|Median
783107|NCT00798434|Secondary|Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Weeks 4, 8, and 12|Nocturnal micturitions defined as micturitions with USS rating 1-5 that occurred between time participant went to bed and time he or she arose to start the next day. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. Calculated as number of nocturnal micturitions divided by number of diary days collected at that visit. Change = observation minus baseline, where lower scores were an improvement/decrease in nocturnal micturitions.|Baseline and Weeks 4, 8, and 12|FAS; n=participants with evaluable data at specific time point. LOCF method used for statistical analyses of the FAS (change from baseline to Week 12).||Micturitions per 24 hours||Standard Deviation|Mean
783108|NCT00798434|Secondary|Percent Change From Baseline in Micturitions Per 24 Hours at Weeks 4, 8, and 12|Micturitions included episodes of voluntary micturition and episodes of UUI. Change = observation minus baseline, where lower scores were an improvement/decrease in micturitions.|Baseline and Weeks 4, 8, and 12|FAS; n=participants with evaluable data at specific time point. LOCF method used for statistical analyses of the FAS (change from baseline to Week 12).||Percent change||Full Range|Median
783109|NCT00798434|Secondary|Change From Baseline in Mean Number of Micturitions Per 24 Hours at Weeks 4, 8, and 12|Micturitions included episodes of voluntary micturition and episodes of UUI, defined as those micturitions with USS rating of 5 (unable to hold; leak urine) in the diary of participants with UUI at baseline. Change = observation minus baseline, where lower scores were an improvement/decrease in micturitions.|Baseline and Weeks 4, 8, and 12|FAS; n=participants with evaluable data at specific time point. LOCF method used for statistical analyses of the FAS (change from baseline to Week 12).||Micturitions per 24 hours||Standard Deviation|Mean
783110|NCT00798434|Secondary|Percent Change From Baseline of Severe Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12|Severe micturition-related urgency episodes defined as those with USS rating >=4. USS rating of 4: Severe feeling of urgency and 5: Unable to hold; leak urine. Change = observation minus baseline, where lower scores were an improvement/decrease in severity of micturition-related urgency.|Baseline and Weeks 4, 8, and 12|FAS; N=participants with evaluable data; n=participants with evaluable data at specific time point. LOCF method used for statistical analyses of the FAS (change from baseline to Week 12).||Percent change||Full Range|Median
783111|NCT00798434|Secondary|Change From Baseline in Mean Number of Severe Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12|Severe micturition-related urgency episodes defined as those with the USS rating >=4. USS rating of 4: Severe feeling of urgency and 5: Unable to hold; leak urine. Change = observation minus baseline, where lower scores were an improvement/decrease in severity of micturition-related urgency episodes.|Baseline and Weeks 4, 8, and 12|FAS; N=participants with evaluable data; n=participants with evaluable data at specific time point. LOCF method used for statistical analyses of the FAS (change from baseline to Week 12).||Episodes per 24 hours||Standard Deviation|Mean
783112|NCT00798434|Secondary|Percent Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12|Micturition-related urgency episodes per 24 hours defined as those with USS Scale rating of >=3 marked for corresponding micturition in diary. USS rating of 3: Moderate feeling of urgency, 4: Severe feeling of urgency, 5: Unable to hold; leak urine. Percent change calculated as: 100* (Urgency Episode at Week x - baseline)/baseline. Change = observation minus baseline, where lower scores were an improvement/decrease in micturition-related urgency episodes.|Baseline and Weeks 4, 8, and 12|FAS;N=participants with evaluable data; n=participants with evaluable data at specific time point. LOCF method used for statistical analyses of the FAS (change from baseline to Week 12).||Percent change||Full Range|Median
783113|NCT00798434|Primary|Change From Baseline in Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 12|Number of micturition-related urgency episodes per 24 hours calculated as number of micturitions with USS rating of greater than or equal to (>=) 3 divided by number of days that diary data was collected at that visit. USS ranged 1 to 5 (1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine). Change = observation minus baseline, where lower scores were an improvement/decrease in micturition-related urgency episodes.|Baseline and Week 12|Full Analysis Set (FAS)=randomized participants who took at least 1 dose of double-blind (DB) treatment, had baseline and post-baseline efficacy data for at least 1 endpoint and at least 1 time point during DB treatment; number of participants analyzed (n)=participants with evaluable data at the specified time point.||Episodes per 24 hours||Standard Deviation|Mean
783114|NCT00798486|Secondary|Number of Participants Who Provided These Ratings For Overall Testing Experience With A1C Test Kit|Subjects rated features of the A1C Test Kit, including 'Overall Testing Experience'. The rating scale was 4 (Excellent) to 1 (Poor).|One hour|||number of participants|||Number
783115|NCT00798486|Secondary|Percentage of Subjects Who Experienced First Time Failures (FTF) During Testing|"For the comprehension analysis, subjects were divided into 2 groups. One group (n=56 subjects) was given both written (Quick Reference Guide) and DVD instruction material. The other group (n=54 subjects) was given only written instruction material. First time failure (FTF) was defined as:
The subject could not use the product without HCP assistance.
The subject could not complete the test. User error rendered one or more parts unusable.
The subject completed the test after one or more mistakes; the result was an error code instead of a numerical value."|One hour|||percentage of subjects|||Number
783116|NCT00798486|Secondary|Average Within Subject Coefficient of Variation CV (PRECISION)|The average Coefficient of Variation (CV) was computed by calculating the square of the CV for each pair of A1c self-test results, averaging this square value over the number of subjects included in the analysis, and then taking the square root.|One hour|Precision Coefficient of Variation (CV)was analyzed using meter results from subject data that had numeric values for duplicate A1c self-tests. Subject data was not used in this outcome measure analysis when there had been a protocol deviation or when one (or both) A1c self-tests resulted in an error code.||average percentage CV|||Number
783117|NCT00798486|Primary|Number of A1C Results Either Equal To Or Within +/- 13.5% of the Laboratory Method (ACCURACY)|This outcome measure reports the number of A1c test results for which the percent difference (absolute value) between results from the subject meter and the laboratory method was less than or equal to 13.5%.|One hour|||number of A1c results|||Number
783118|NCT00798577|Secondary|Microbiological Culture Evaluation/Eradication Percent - Staphylococcus Aureus, Steptococcus Pneumoniae, and Enterobacter Cloacae|Eradication percent (absence of specified bacteria) of each bacteria identified at Day 1|24 hours after administration of first dose|No patients in the Vigamox group had Staphylococcus aureus, Steptococcus pneumoniae, or Enterobacter cloacae identified at Day 1.||Percent bacteria eradicated|||Number
783119|NCT00798577|Secondary|Microbiological Culture Evaluation/Eradication Percent - Eradication of All Other Isolates and Corynform-like|Eradication percent (absence of specified bacteria) of each bacteria identified at Day 1|24 hour after administration of first dose|No patients in the Placebo group had Corynform-like bacteria (or other types of bacteria) identified at Day 1||Percent bacteria eradicated|||Number
783120|NCT00798577|Secondary|Microbiological Culture Evaluation/Eradication Percent - Enterobacter Faecalis and Candida Albicans|Eradication percent (absence of specified bacteria) of each bacteria identified at Day 1|24 hours after administration of first dose|||Percent bacteria eradicated|||Number
783121|NCT00798577|Secondary|Exploratory Evaluation of Changes in Ocular Signs and Symptoms|"Number of patients who had clinical resolution (0 on all scales below) from baseline (Day 1) to Day 2 in ocular and symptoms of bacterial conjunctivitis:
Bulbar Conjunctival Injection – 0 (none) to 4 (Severe) scale. Conjunctival Discharge (Mucopurulent) - 0 (none) to 3 (Severe) scale. Lid Erythema – 0 (none) to 3 (Severe) scale. Lid Swelling – 0 (none) to 3 (Severe) scale. Palpebral Conjunctiva – 0 (none) to 3 (Severe) scale. Foreign Body Sensation - 0 (none) to 3 (Severe) scale. Tearing - 0 (none) to 3 (Severe) scale. Photophobia - 0 (none) to 3 (Severe) scale."|Baseline (Day 1) to Day 2|||Participants|||Number
783122|NCT00798577|Primary|Exploratory Outcomes From Digital Photography|Photographs were taken before and after treatment. Outcome is the number of patients whose photographs showed a subjective visual change based upon an exploratory review of patient photographs in signs of bacterial conjunctivitis before and after treatment.|24 hours after administration of first dose|||Participants|||Number
783123|NCT00798590|Secondary|Compare the Number of Hypoglycemic Events Between GLP-1/Placebo Treatment||2 years|The PI left the institution and this study was terminated due to noncompliance with our Institutional Review Board. Outcome measure data, if collected, is unknown since no data are available.|||||
783124|NCT00798590|Primary|To Compare the Composite Overall Amount of Insulin Used With GLP-1 vs. Placebo to Reach and Maintain the ICU-specific Target Glucose Range.||2 years|The PI left the institution and this study was terminated due to noncompliance with our Institutional Review Board. Outcome measure data, if collected, is unknown since no data are available.|||||
783125|NCT00798603|Secondary|Change From Baseline to Cycle 5 in Nausea Assessed by Treatment-specific Adverse Events Scale|The single-item nausea question was on a 10-points scale with 0=no nausea and 10=as bad as you can imagine. The item scores was translated onto a 0 to 100 point scale, with lower values indicating worse symptoms. Change from baseline to cycle 5 was calculated by subtracting the baseline scores from the scores at cycle 5.|Baseline and Cycle 5|All participants who met the eligibility criteria, have started the study treatment and had baseline and cycle 5 nausea data.||units on a scale||Full Range|Median
783126|NCT00798603|Secondary|Change From Baseline to Cycle 3 in Nausea Assessed by Treatment-specific Adverse Events Scale|The single-item nausea question was on a 10-points scale with 0=no nausea and 10=as bad as you can imagine. The item scores was translated onto a 0 to 100 point scale, with lower values indicating worse symptoms. Change from baseline to cycle 3 was calculated by subtracting the baseline scores from the scores at cycle 3.|Baseline and Cycle 3|All participants who met the eligibility criteria, have started the study treatment and had baseline and cycle 3 nausea data.||units on a scale||Full Range|Median
783127|NCT00798603|Secondary|Change From Baseline to Cycle 5 in Neuropathy Assessed by Treatment-specific Adverse Events Scale|The single-item neuropathy question was on a 10-points scale with 0=no numbness or tingling in fingers and toes and 10=worst numbness or tingling in fingers and toes imaginable. The item scores was translated onto a 0 to 100 point scale, with lower values indicating worse symptoms. Change from baseline to cycle 5 was calculated by subtracting the baseline scores from the scores at cycle 5.|Baseline and Cycle 5|All participants who met the eligibility criteria, have started the study treatment and had baseline and cycle 5 neuropathy data.||units on a scale||Full Range|Median
783128|NCT00798603|Secondary|Change From Baseline to Cycle 3 in Neuropathy Assessed by Treatment-specific Adverse Events Scale|The single-item neuropathy question was on a 10-points scale with 0=no numbness or tingling in fingers and toes and 10=worst numbness or tingling in fingers and toes imaginable. The item scores was translated onto a 0 to 100 point scale, with lower values indicating worse symptoms. Change from baseline to cycle 3 was calculated by subtracting the baseline scores from the scores at cycle 3.|Baseline and Cycle 3|All participants who met the eligibility criteria, have started the study treatment and had baseline and cycle 3 neuropathy data.||units on a scale||Full Range|Median
783129|NCT00798603|Secondary|Change From Baseline to Cycle 5 in Fatigue Assessed by Treatment-specific Adverse Events Scale|The single-item fatigue question was on a 10-points scale with 0=no fatigue and 10=as bad as you can imagine. The item scores was translated onto a 0 to 100 point scale, with lower values indicating worse symptoms. Change from baseline to cycle 5 was calculated by subtracting the baseline scores from the scores at cycle 5.|Baseline and Cycle 5|All participants who met the eligibility criteria, have started the study treatment and had baseline and cycle 5 fatigue data.||units on a scale||Full Range|Median
785028|NCT00834639|Primary|Cmax (Maximum Observed Concentration)|Bioequivalence based on Cmax.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||µg/mL||Standard Deviation|Mean
783130|NCT00798603|Secondary|Change From Baseline to Cycle 3 in Fatigue Assessed by Treatment-specific Adverse Events Scale|The single-item fatigue question was on a 10-points scale with 0=no fatigue and 10=as bad as you can imagine. The item scores was translated onto a 0 to 100 point scale, with lower values indicating worse symptoms. Change from baseline to cycle 3 was calculated by subtracting the baseline scores from the scores at cycle 3.|Baseline and Cycle 3|All participants who met the eligibility criteria, have started the study treatment and had baseline and cycle 3 fatigue data.||units on a scale||Full Range|Median
783131|NCT00798603|Secondary|Change From Baseline to Cycle 5 in Overall Quality of Life Assessed by Linear Analogue Self Assessment (LASA)|The overall quality of life (QOL) question was on a 10-points scale with 0=as bad as it can be and 10=as good as it can be. The QOL scores was translated onto a 0 to 100 point scale, with lower values indicating worse symptoms. Change from baseline to cycle 5 was calculated by subtracting the baseline scores from the scores at cycle 5.|Baseline and Cycle 5|All participants who met the eligibility criteria, have started the study treatment and had baseline and cycle 5 LASA data.||units on a scale||Full Range|Median
783132|NCT00798603|Secondary|Change From Baseline to Cycle 3 in Overall Quality of Life Assessed by Linear Analogue Self Assessment (LASA)|The overall quality of life (QOL) question was on a 10-points scale with 0=as bad as it can be and 10=as good as it can be. The QOL scores was translated onto a 0 to 100 point scale, with lower values indicating worse symptoms. Change from baseline to cycle 3 was calculated by subtracting the baseline scores from the scores at cycle 3.|Baseline and Cycle 3|All participants who met the eligibility criteria, have started the study treatment and had baseline and cycle 3 LASA data.||units on a scale||Full Range|Median
783133|NCT00798603|Secondary|Change From Baseline to Cycle 5 in Quality of Life (QOL) as Assessed by the Lung Cancer Symptom Scale|Lung Cancer Symptom Scale (LCSS) consist of 9 items that assess the symptoms of lung cancer during the past days on a 10-points scale with 0 as no symptoms and 10 as worse symptoms. The individual item score was translated onto a 0-100 point scale with lower values indicating worse symptoms. An average of the aggregate score of all 9 items was used for a total score. Change from baseline to cycle 5 was calculated by subtracting the baseline scores from the scores at cycle 5.|Baseline and Cycle 5|All participants who met the eligibility criteria, have started the study treatment and had baseline and cycle 5 LCSS data.||units on a scale||Full Range|Median
783134|NCT00798603|Secondary|Change From Baseline to Cycle 3 in Quality of Life (QOL) as Assessed by the Lung Cancer Symptom Scale|Lung Cancer Symptom Scale (LCSS) consist of 9 items that assess the symptoms of lung cancer during the past days on a 10-points scale with 0 as no symptoms and 10 as worse symptoms. The individual item score was translated onto a 0-100 point scale with lower values indicating worse symptoms. An average of the aggregate score of all 9 items was used for a total score. Change from baseline to cycle 3 was calculated by subtracting the baseline scores from the scores at cycle 3.|Baseline and Cycle 3|All participants who met the eligibility criteria, have started the study treatment and had baseline and cycle 3 LCSS data.||units on a scale||Full Range|Median
783135|NCT00798603|Secondary|Overall Survival|Overall survival was defined as the time from study enrollment to the time of death from any cause. Overall survival will be censored at the date of the last follow-up visit for patients who are still alive or lost to follow-up.|Up to 5 years|All participants who met the eligibility criteria and have started the study treatment.||months||95% Confidence Interval|Median
783136|NCT00798603|Secondary|Progression-free Survival|Progression-free survival was defined as the time from study enrollment to the first date of disease progression or death as a result of any cause, whichever occurs first. Progression-free survival will be censored at the date of the last contact for patients who are still alive and who have not had disease progression.|Up to 5 years|All participants who met the eligibility criteria and have started the study treatment.||months||95% Confidence Interval|Median
783137|NCT00798603|Secondary|Time to Treatment Failure|Time to treatment failure was defined to be the time from date of registration to the date at which the patient is removed from the treatment due to progression, toxicity, refusal or death from any cause.|Up to 5 years|All participants who met the eligibility criteria and have started the study treatment.||months||95% Confidence Interval|Median
783138|NCT00798603|Secondary|Number of Grade 3 or Higher Adverse Events Occurring in >=10% of Patients|Adverse events were assessed by Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grading: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death.|Up to 2.5 years|All participants who received treatment.||particpants|||Number
783139|NCT00798603|Secondary|Duration of Response|Duration of response for responders was defined as the time from the date of the first objective status assessment of a confirmed CR or PR to the first date of disease progression. Duration of response will be censored at the date of last post-therapy follow-up visit for responders who have not had disease progression. Duration of response will be calculated for all evaluable patients who have achieved an objective confirmed response.|Up to 5 years|All participants who met the eligibility criteria, have started the study treatment and had confirmed CR or PR.||months||95% Confidence Interval|Median
783140|NCT00798603|Secondary|Proportion of Confirmed Tumor Response Defined as an Objective Status of Complete Response or Partial Response on Two Consecutive Evaluations|"Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria:
Complete Response (CR): disappearance of all target and non-target lesions and no new lesions.
Partial Response (PR): disappearance of all target lesions, persistence of one or more non-target lesions, and no new lesions; or at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD, no appearance of one/more new lesions, unequivocal progression of existing non-target lesions, and no new lesions."|Duration of study until progression (up to 5 years)|All participants who met the eligibility criteria, have started the study treatment and have post-baseline disease assessments.||percentage of participants||95% Confidence Interval|Number
783141|NCT00798603|Primary|Progression-free Survival at 6 Months|Estimated using the Binomial point estimator (number of successes divided by the total number of evaluable patients). A patient is classified as a success if alive and progression-free at 6 months.|6 months|The first 55 participants who met the eligibility criteria and have started the study treatment.||percentage of participants||95% Confidence Interval|Number
783142|NCT00798655|Secondary|Probability of 2-year Overall Survival||Up to 90 months for cohort; individual patients up to 24 months|Patients who received 60-66 Gy over 6-7 weeks) concurrent with cisplatin 30 mg/m^2 and at least once dose of panitumumab 2.5 mg/kg.||percentage of participants||95% Confidence Interval|Number
783144|NCT00798707|Other Pre-specified|Discontinuation-Emergent Signs and Symptoms (DESS) Total Score|DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of “new symptoms” and “old (but worse) symptoms” (1) and 0 for “old and unchanged symptom,” “absent,” or “old symptom but improved” for a total possible range of 0 to 43. A higher score indicates more symptoms.|Week 8 to 10 (or ET)|Analysis included completers for exposure (those whose exposure duration was at least 53 days) among safety population. 'n' is participants who received drug and were evaluated for measure at timepoint for each group respectively.||Units on a scale||Standard Deviation|Mean
783145|NCT00798707|Other Pre-specified|Number of Participants With Categorical Scores on the C-SSRS at FOT Evaluation (Week 8 or ET)|C-SSRS mapped into C-CASA(1-7) to assess whether participant:completed suicide(1),suicide attempt(2)(response of “Yes” on “Actual Attempt”),preparatory acts toward imminent suicidal behavior (3)(“Yes” on “Preparatory Acts or Behavior”),suicidal ideation (4)(“Yes” on “Wish to be dead”,“Non-Specific Active Suicidal Thoughts”,“Active Suicidal Ideation with methods without Intent to Act or Some Intent to Act,without Specific Plan or with Specific Plan and Intent),any suicidal behavior or ideation,self-injurious behaviour(7)(“Yes” on “Has subject engaged in Non-suicidal Self-Injurious Behavior”).|Week 8 (or ET)|The safety population included all participants randomly assigned to treatment who had taken at least 1 dose of double-blind study drug.||Participants|||Number
783146|NCT00798707|Other Pre-specified|Percentage of Participants With Sexual Dysfunction at FOT Evaluation (Week 8 or ET)|ASEX scale includes 5 questions that evaluate sexual function exclusively during the week prior to completion in the following areas: libido, excitability and ability to reach orgasm. Sexual dysfunction=an ASEX total score of 19 or greater, or a score of 5 or greater on any item, or a score of 4 or greater on any 3 items. Participants who have had no sexual activity during the prior week should be instructed to not complete questions 3 through 5.|Week 8 (or ET)|The safety population included all participants randomly assigned to treatment who had taken at least 1 dose of double-blind study drug.||Percentage of Participants|||Number
783147|NCT00798707|Other Pre-specified|Change From Baseline in WHO-5 Total Score at FOT Evaluation (Week 8 or ET)|WHO-5 evaluates positive psychological well-being. WHO-5 consists of 5 questions and each is rated on a 6-point scale. The total score ranges from 0 to 25 (0= worst possible quality of life; 25=best possible quality of life).|Baseline and Week 8 (or ET)|ITT Population: all randomly assigned participants with baseline primary efficacy evaluation had taken at least 1 dose of double-blind drug and 1 primary efficacy evaluation after first dose of double-blind drug. If participant had missing value at any visit, LOCF method of imputation was used.||Units on a scale||Standard Error|Mean
783148|NCT00798707|Other Pre-specified|Change From Baseline in SDS at FOT Evaluation (Week 8 or ET)|SDS: a self-administered tool that measures functional impairment in 3 domains: Work/School, Social Life, and Family Life/Home Responsibilities. The participant rates the extent to which each of these domains is impaired by his/her symptoms using a 10 point visual analog scale: (0=not at all impaired, 10=extremely impaired) for a total maximum score of 30.|Baseline and Week 8 (or ET)|ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation,had taken at least 1 dose of double-blind study drug,had at least 1 primary efficacy evaluation after first dose of double-blind drug.'n' is participants who received drug and were evaluated for measure at timepoint for each group respectively.||Units on a scale||Standard Error|Mean
783149|NCT00798707|Other Pre-specified|Population Pharmacokinetics for Desvenlafaxine Plasma Concentrations|Relationship of demographic variables (age, gender, food, race, creatinine, aspartate aminotransaminase, alanine transaminase, bilirubin and concomitant medications) were examined by fitting measured DVS plasma concentrations to a 1 compartment model with first order absorption. Demographic variables were examined for clearance (CL/F), volume of distribution (V/F), Steady Area under Curve (AUC) using nonlinear mixed effects modeling. Final parameter estimates for demographic factors effecting CL/F, V/F and AUC were determined.|Week 2, 4 and 8 (or ET)|PK population; data was insufficient examine the effect of demographic variables on the PK of desvenlafaxine. Parameter values were calculated for variables altering CL/F, AUC and V/F. Population parameters from nonlinear mixed effects modeling were not summarized as descriptive statistics.||nanogram(ng)/mL||Standard Deviation|Mean
783150|NCT00798707|Secondary|Number of Participants With a Response on the CGI-I Score at FOT Evaluation (Week 8 or ET)|CGI-I responder was defined as a participant with a score of 1 (very much improved) or 2 (much improved) on the CGI-I. CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Week 8 (or ET)|ITT Population: all randomly assigned participants with baseline primary efficacy evaluation had taken at least 1 dose of double-blind drug and 1 primary efficacy evaluation after first dose of double-blind drug. If participant had missing value at any visit, LOCF method of imputation was used.||Participants|||Number
783151|NCT00798707|Secondary|Number of Participants With a Response on the MADRS Score at FOT Evaluation (Week 8 or ET)|A MADRS responder was defined as a participant with a 50% or greater decrease from baseline in MADRS score. It measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Week 8 (or ET)|ITT Population: all randomly assigned participants with baseline primary efficacy evaluation had taken at least 1 dose of double-blind drug and 1 primary efficacy evaluation after first dose of double-blind drug. If participant had missing value at any visit, LOCF method of imputation was used.||Participants|||Number
783152|NCT00798707|Secondary|Number of Participants in Remission Based on the HAM-D17 at FOT Evaluation (Week 8 or ET)|Remission was defined as a HAM-D17 score of less than or equal to 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe, for a maximum total score of 50.|Week 8 (or ET)|ITT Population: all randomly assigned participants with baseline primary efficacy evaluation had taken at least 1 dose of double-blind drug and 1 primary efficacy evaluation after first dose of double-blind drug. If participant had missing value at any visit, LOCF method of imputation was used.||Participants|||Number
783153|NCT00798707|Secondary|Number of Participants With a Response on the HAM-D17 at FOT Evaluation (Week 8 or ET)|A HAM-D17 responder was defined as a participant with a 50% or greater decrease from baseline in HAM-D17 score. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe, for a maximum total score of 50.|Week 8 (or ET)|ITT Population: all randomly assigned participants with baseline primary efficacy evaluation had taken at least 1 dose of double-blind drug and 1 primary efficacy evaluation after first dose of double-blind drug. If participant had missing value at any visit, LOCF method of imputation was used.||Participants|||Number
783154|NCT00798707|Secondary|Change From Baseline in HAM-D6 Total Score at FOT Evaluation (Week 8 or ET)|HAM-D6: a standardized, clinician-administered rating scale that assesses 6 items characteristically associated with major depression and is a subset of HAM-D17. HAM-D6 score ranges from 0-22. The scale uses HAM-D17 items: 1, 2, 7, 8, 10 and 13. Item 13 is scored 0-2 and all others are scored 0-4.|Baseline and Week 8 (or ET)|ITT Population: all randomly assigned participants with baseline primary efficacy evaluation had taken at least 1 dose of double-blind drug and 1 primary efficacy evaluation after first dose of double-blind drug. If participant had missing value at any visit,LOCF method of imputation was used.||Units on a scale||Standard Error|Mean
783155|NCT00798707|Secondary|Change From Baseline in MADRS Total Score at FOT Evaluation (Week 8 or ET)|MADRS measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline and Week 8 (or ET)|ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study drug, and had at least 1 primary efficacy evaluation after first dose of double-blind study drug. If participant had a missing value at any visit, LOCF method of imputation was used.||Units on a scale||Standard Error|Mean
783156|NCT00798707|Secondary|Change From Baseline in Mean CGI-S Score at FOT Evaluation (Week 8 or ET)|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected.|Baseline and Week 8 (or ET)|ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study drug, and had at least 1 primary efficacy evaluation after first dose of double-blind study drug. If participant had a missing value at any visit, LOCF method of imputation was used.||Units on a scale||Standard Error|Mean
783157|NCT00798707|Secondary|Number of Participants With Categorical Scores on CGI–Improvement (CGI-I) at FOT Evaluation (Week 8 or ET)|CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Week 8 (or ET)|ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study drug, and had at least 1 primary efficacy evaluation after first dose of double-blind study drug. If participant had a missing value at any visit, LOCF method of imputation was used.||Participants|||Number
783158|NCT00798707|Primary|Change From Baseline in HAM-D17 Total Score at the Final On-therapy (FOT)Evaluation (Week 8 or ET)|HAM-D17: a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe, for a maximum total score of 50.|Baseline and Week 8 (or ET)|Intent-To-Treat (ITT) Population:all randomly assigned participants with baseline primary efficacy evaluation, had taken at least 1 dose of double-blind drug and 1 primary efficacy evaluation after first dose of double-blind drug. If participant had missing value at any visit, last observation carried forward (LOCF) method of imputation was used.||Units on a scale||Standard Error|Mean
783159|NCT00798720|Secondary|Toxicity|Graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0|30 days post-treatment|||participants|||Number
783160|NCT00798720|Secondary|Median Overall Survival||5 years|||months||95% Confidence Interval|Median
783161|NCT00798720|Secondary|Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by MRI, CT, or chest x-ray: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR+PR.|Until disease progression, up to 2 years|||participants|||Number
783162|NCT00798720|Primary|Three-month Progression-free Survival|"Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since the treatment started or the appearance of one or more new lesions."|Three-months post-treatment|||percentage of participants||95% Confidence Interval|Number
783163|NCT00798759|Secondary|Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Ocular Surface Disease Index (OSDI) Score|The OSDI is a 12-question validated questionnaire (resultant overall 0-100 score) used to measure ocular symptoms, visual function, and environmental factors that may affect a patient's vision, where 0 = normal and 100 = severe. The OSDI questionnaire was administered at both visits and completed by the patient with no assistance from the office staff, physician, or anyone else. The baseline OSDI score was subtracted from the 12-week OSDI score and reported as change. A negative number represents a perceived improvement in ocular health.|Day 0, Day 84|Intent-to-Treat: All patients who received test article and completed the trial.||Units on a scale||Standard Error|Mean
783164|NCT00798759|Primary|Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Tear Film Break-Up Time (TFBUT)|Tear film break-up time was assessed by the same examiner both visits using the same slitlamp/settings. Examiner instilled fluorescein onto the patient's eye, after which the patient blinked several times, then kept the eye open. Immediately thereafter, the examiner used a stopwatch to time the occurrence of the first break in the fluorescein film. Three consecutive measurements were taken and averaged for actual TBUT. TBUT at Baseline (Day 0) was subtracted from TBUT at 12 weeks (Day 84) and reported as change. A higher number represents a lengthening in the tear film break up time.|Day 0, Day 84|Intent-to-Treat: All patients who received test article and completed the trial.||Seconds||Standard Error|Mean
783166|NCT00798967|Secondary|Absolute Change in PN/I.V. Volume From Baseline to Last Time Point|Absolute change in the volume of PN/I.V. from baseline (Week 0) to the visit when the last data point was collected (week 4 through week 24, or earlier if the subject discontinued early).|Week 0 to last visit when data was collected.|Intent-to-Treat (ITT) was defined for efficacy analyses which included all randomized patients.||Liters/Week||Standard Deviation|Mean
783167|NCT00798967|Primary|Responder|Comparison of subjects treated with teduglutide to placebo who achieve a 20 to 100% reduction from baseline in weekly parenteral nutrition/intravenous fluid (PN/I.V.) volume at weeks 20 and 24.|Weeks 20 and 24|Percentages were based on the number of subjects in the Intent to Treat (ITT) population.||subjects|||Number
783168|NCT00804570|Secondary|Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Total Score at Week 16 Endpoint|The GSRS is a clinician-administered scale used to assess upper and lower gastrointestinal physical symptoms. 15 items covering domains of abdominal pain, reflux syndrome, indigestion syndrome, diarrhea syndrome, and constipation syndrome were assessed with a 1-week recall period. Total scores range from 0-45. Higher scores indicate greater severity of symptoms. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, gender, family history, visit, baseline, gender*family history, treatment*visit, baseline*visit. An unstructured covariance structure was used.|Baseline, Week 16|Participants with a baseline and post-baseline value.||units on a scale||Standard Error|Least Squares Mean
783169|NCT00804570|Secondary|Number of Participants With Clinical Institute Withdrawal Assessment for Alcohol Scale (CIWA-Ar)≥10 at Any Time From Baseline Through Week 16 Endpoint|The revised CIWA-Ar scale measured the severity of alcohol withdrawal by rating 10 signs and symptoms: nausea; tremor; autonomic hyperactivity; anxiety; agitation; tactile, visual, and auditory disturbances; headache; and disorientation. Total scores range from 0-67. Higher scores indicate greater severity of withdrawal.|Baseline through Week 16|Participants who took at least one dose of study drug.||participants|||Number
783170|NCT00804570|Secondary|Change From Baseline in Orthostatic Pulse Rate at Week 16 Endpoint|Orthostatic pulse rate is the pulse rate measured within 3 minutes of standing. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, baseline, treatment*visit. An unstructured covariance structure was used.|Baseline, Week 16|Participants who took at least one dose of study drug.||beats per minute||Standard Error|Least Squares Mean
783171|NCT00804570|Secondary|Change From Baseline in Orthostatic Blood Pressure (BP) at Week 16 Endpoint|Orthostatic BP is the BP measured within 3 minutes of standing. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, baseline, treatment*visit. An unstructured covariance structure was used.|Baseline, Week 16|||mmHg||Standard Error|Least Squares Mean
783172|NCT00804570|Secondary|Percentage of Participants With Treatment-Emergent Adverse Events (TEAE)|Percentage of participants had one or more TEAEs during treatment period. TEAE is a worsening or new occurrence of adverse event during treatment compared to baseline.|Baseline through Week 16|Participants who took at least one dose of study drug.||percentage of participants|||Number
783173|NCT00804570|Secondary|Percentage of Participants Discontinuation Due to Adverse Events (AEs)|Percentage of participants discontinued study due to one or more AEs.|Baseline through Week 16|Participants who took at least one dose of study drug.||percentage of participants|||Number
783174|NCT00804570|Secondary|Change From Baseline in QTc Fridericia's Correction Interval (QTcF) Measured by Electrocardiograms at Week 16 Endpoint|Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, baseline, treatment*visit. An unstructured covariance structure was used.|Baseline, Week 16|Participants who took at least one dose of study drug.||milliseconds||Standard Error|Least Squares Mean
783175|NCT00804570|Secondary|Change From Baseline in Supine Pulse Rate at Week 16 Endpoint|Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, baseline, treatment*visit. An unstructured covariance structure was used.|Baseline, Week 16|Participants who took at least one dose of study drug.||beats per minute (bpm)||Standard Error|Least Squares Mean
783176|NCT00804570|Secondary|Change From Baseline in Supine Blood Pressure (BP) at Week 16 Endpoint|Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, baseline, treatment*visit. An unstructured covariance structure was used.|Baseline, Week 16|Participants who took at least one dose of study drug.||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
783177|NCT00804570|Secondary|Population Pharmacokinetic (PK) - Apparent Volume of Distribution|Plasma concentrations were analyzed using population PK methodology with non-linear mixed effect modeling (NONMEM) software.|Over 16 weeks|Participants who took study drug and contributed PK sample.||Liter (L)||Standard Error|Mean
783178|NCT00804570|Secondary|Population Pharmacokinetic (PK) - Apparent Clearance|Plasma concentrations were analyzed using population PK methodology with non-linear mixed effect modeling (NONMEM) software.|Over 16 weeks|Participants who took study drug and contributed PK sample.||Liter/hour (L/hr)||Standard Error|Mean
783179|NCT00804570|Secondary|Change From Baseline in Endicott Work Productivity Scale (EWPS) Total Score at Week 16 Endpoint|EWPS is a self-rated work productivity scale that assesses such topics as work hours, work missed, and behaviors and feelings related to the workplace. The EWPS will be completed only by subjects who work outside the home. There are 25 items and total scores range from 0-100. Higher scores indicate poorer productivity. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, gender, family history, visit, baseline, gender*family history, treatment*visit, baseline*visit. An unstructured covariance structure was used.|Baseline, Week 16|Participants with a baseline and post-baseline value.||units on a scale||Standard Error|Least Squares Mean
783180|NCT00804570|Secondary|Change From Baseline in Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) Total Score at Week 16 Endpoint|Q-LES-Q-SF is a self-report instrument that assesses the degree of enjoyment and satisfaction in daily life activities. The domains include: social relationships, living or house situation, and physical health. Total scores range from 14-70. Higher scores indicate better quality of life. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, gender, family history, visit, baseline, gender*family history, treatment*visit, baseline*visit. An unstructured covariance structure was used.|Baseline, Week 16|Participants with a baseline and post-baseline value.||units on a scale||Standard Error|Least Squares Mean
783210|NCT00804648|Primary|Stinging on Instillation|Assessed from subject response to survey question asking about tolerability of medicine upon instillation, using a 0 through 7 scale, with 0=complete comfort and 7=worst pain imaginable.|following 3 days of treatment|||Units on a scale||Standard Deviation|Mean
783181|NCT00804570|Secondary|Change From Baseline in Thoughts About Abstinence Scale at Week 16 Endpoint|Thoughts About Abstinence Scale was to measure participant's commitment to abstinence. It includes 3 items on a scale of 1-10: own desire to stop drinking (1=no desire to quit); own expectation of success in quitting (1=lowest expectation of success); how difficult to quit and remain abstinent (1=lowest amount of difficulty); and their goal related to alcohol use (scale of 1-7: 1=having no goal, up to total abstinence at 6 [7 was none of 6 above]). Least Squares (LS) Mean value was controlled for treatment, pooled investigator, gender, family history, baseline, gender*family history.|Baseline, Week 16|Participants with a baseline and post-baseline value.||units on a scale||Standard Error|Least Squares Mean
783182|NCT00804570|Secondary|Change From Baseline in Barratt Impulsivity Scale-11 (BIS-11) Total Score at Week 16 Endpoint|The BIS-11 is a 30-item, self-administered impulsivity scale. Motor, cognitive, and non-planning domains are assessed and a total score is computed. This scale has previously been used in substance-abusing populations. Total scores range from 30-120. Higher scores indicate greater severity of symptoms. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, gender, family history, baseline, gender*family history.|Baseline, Week 16|Participants with a baseline and post-baseline value.||units on a scale||Standard Error|Least Squares Mean
783183|NCT00804570|Secondary|Change From Baseline in Beck Anxiety Inventory (BAI) Total Score at Week 16 Endpoint|BAI is a 21-item patient-completed questionnaire designed to assess the characteristics of anxiety. Participant was asked to rate how much he or she has been bothered by each symptom over the past week. Each item is rated on a 4-point scale (0=not present; 3=present in the extreme). Total scores range from 0 to 63. The higher the score, the more severe the anxiety symptoms. LS Mean value was controlled for treatment, pooled investigator, gender, family history, visit, baseline, gender*family history, treatment*visit, baseline*visit. An unstructured covariance structure was used.|Baseline, Week 16|Participants with a baseline and post-baseline value.||units on a scale||Standard Error|Least Squares Mean
783184|NCT00804570|Secondary|Change From Baseline in Beck Depression Inventory II (BDI-II) Total Score at Week 16 Endpoint|The BDI-II contains 21 items that characterize how the subject was feeling in the past 2 weeks. There is a 4-point scale for each item ranging from 0 to 3 (0=no depression; 3=very depressed). Total scores range from 0-63. Higher scores indicate greater severity of depression. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, gender, family history, baseline, gender*family history, treatment*visit, baseline*visit. An unstructured covariance structure was used.|Baseline, Week 16|Participants with a baseline and post-baseline value.||units on a scale||Standard Error|Least Squares Mean
783185|NCT00804570|Secondary|Ratio of Geometric Means Over Baseline in Aspartate Transaminase (AST) Level at Week 16 Endpoint|AST is a potential biomarker for LY2196044 efficacy as decreases reflect decreased alcohol consumption. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, gender, family history, baseline, gender*family history, treatment*visit, baseline*visit. An unstructured covariance structure was used.|Week 16|Participants with a baseline and post-baseline value.||ratio||Standard Error|Geometric Mean
783186|NCT00804570|Secondary|Ratio of Geometric Means Over Baseline in Percent Carbohydrate-Deficient Transferrin (%CDT) Level at Week 16 Endpoint|Gamma-Glutamyltransferase (GGT) and %CDT will be used as biochemical markers of alcohol consumption. A combination of GGT and %CDT improves the sensitivity of detecting excessive alcohol consumption as compared to either marker alone, or other traditional markers. Elevated levels indicate heavy alcoholism. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, gender, family history, baseline, gender*family history, treatment*visit, baseline*visit. An unstructured covariance structure was used.|Week 16|Participants with a baseline and post-baseline value.||ratio||Standard Error|Geometric Mean
783187|NCT00804570|Secondary|Ratio of Geometric Means Over Baseline in Gamma-Glutamyltransferase (GGT) Level at Week 16 Endpoint|GGT and carbohydrate-deficient transferrin (%CDT) will be used as biochemical markers of alcohol consumption. A combination of GGT and %CDT improves the sensitivity of detecting excessive alcohol consumption as compared to either marker alone, or other traditional markers. Elevated levels indicate heavy alcoholism. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, gender, family history, baseline, gender*family history, treatment*visit, baseline*visit. An unstructured covariance structure was used.|Week 16|Participants with a baseline and post-baseline value.||ratio||Standard Error|Geometric Mean
783188|NCT00804570|Secondary|Change From Baseline in Drinker Inventory of Consequences (DrInC) - Recent Consequences (DrInC-2R) Total Score at Week 16 Endpoint|DrInC is a self-administered, 50-item questionnaire designed to measure adverse consequences of alcohol abuse in 5 areas: Interpersonal, Physical, Social, Impulsive, and Intrapersonal. DrInC-2R provides a measurement since the last interview. Total scores range from 0-150, and higher scores indicate greater severity of symptoms. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, gender, family history, baseline, gender*family history, treatment*visit, baseline*visit. Subject was treated as a random effect. An unstructured covariance structure was used.|Baseline, Week 16|Participants with a baseline and post-baseline value.||units on a scale||Standard Error|Least Squares Mean
783189|NCT00804570|Secondary|Change From Baseline in Obsessive Compulsive Drinking Scale (OCDS) Total Score at Week 16 Endpoint|Cravings will be assessed using the OCDS. The OCDS is a 14-item self-rating instrument. Total scores range from 0-40. Higher scores indicate more obsessive and craving. Least Squares (LS) Mean value was controlled for treatment, site, visit, gender, history, baseline, gender*history, treatment*visit, baseline*visit, gender*treatment, gender*treatment*visit. Subject was treated as a random effect. An unstructured covariance structure was used.|Baseline, Week 16|Participants with a baseline and post-baseline value.||units on a scale||Standard Error|Least Squares Mean
783190|NCT00804570|Secondary|Change From Baseline in Drinks Per Heavy Drinking Day at Week 16 Endpoint|The Timeline Followback Method assesses the subject’s daily drinking by means of a calendar that covers a specific time period and was used to assess the number of drinks consumed on heavy drinking days. Heavy drinking is defined as ≥4 drinks/day for women and ≥5 drinks/day for men. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, gender, family history, treatment*visit, gender*family history, baseline, and baseline*visit. An unstructured covariance structure was used.|Baseline, Week 16|Participants with a baseline and post-baseline value.||number of drinks/heavy drinking day||Standard Error|Least Squares Mean
785074|NCT00834964|Secondary|Cmax - O-Desmethylvenlafaxine in Plasma|Informational Purposes Only|Blood samples collected over 24 hour period|Data from first 24 completed subjects were included in the statistical analysis per protocol.||ng/mL||Standard Deviation|Mean
783191|NCT00804570|Secondary|Change From Baseline in Drinks Per Drinking Day at Week 16 Endpoint|The Timeline Followback Method assesses the subject’s daily drinking by means of a calendar that covers a specific time period and was used to assess the number of drinks consumed on the days the participant drank. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, gender, family history, treatment*visit, gender*family history, baseline, and baseline*visit. An unstructured covariance structure was used.|Baseline, Week 16|Participants with a baseline and post-baseline value.||number of drinks/drinking day||Standard Error|Least Squares Mean
783192|NCT00804570|Secondary|Change From Baseline in Percentage of Days Abstinent at Week 16 Endpoint|The Timeline Followback Method assesses the subject’s daily drinking by means of a calendar that covers a specific time period and was used to assess the percentage of days abstinent. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, gender, family history, treatment*visit, gender*family history, baseline, and baseline*visit. An unstructured covariance structure was used.|Baseline, Week 16|Participants with a baseline and post-baseline value.||percentage of days||Standard Error|Least Squares Mean
783193|NCT00804570|Secondary|Change From Baseline in Drinks Per Day at Week 16 Endpoint|The Timeline Followback Method assesses the subject’s daily drinking by means of a calendar that covers a specific time period and was used to assess the number of drinks consumed per day. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, gender, family history, treatment*visit, gender*family history, baseline, and baseline*visit. An unstructured covariance structure was used.|Baseline, Week 16|Participants with a baseline and post-baseline value.||number of drinks/day||Standard Error|Least Squares Mean
783194|NCT00804570|Primary|Percentage of Heavy Drinking Days at Week 16 Endpoint|The Timeline Followback Method assesses the subject’s daily drinking by means of a calendar that covers a specific time period and was used to assess the number of heavy drinking days. Heavy drinking is defined as ≥4 drinks/day for women and ≥5 drinks/day for men. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, gender, family history, treatment*visit, gender*family history, baseline, and baseline*visit. An unstructured covariance structure was used.|Week 16|Participants with a baseline and post-baseline value.||percentage of days||Standard Error|Least Squares Mean
783195|NCT00804596|Secondary|Number of Capillary Blood Results Within +/- 15mg/dL or +/- 20% of Laboratory Glucose Method|Subjects with diabetes and healthcare professionals (HCPs) used a new Blood Glucose Monitoring System (BGMS) with subject capillary blood. The BGMS has programmed algorithms to provide results equivalent to either serum/plasma or whole blood glucose methods; this study evaluated results equivalent to plasma lab methods. All results were compared to a lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were obtained in duplicate from subjects using three lots of Contour Blood Glucose strips, evenly distributed among the subjects.|1-2 hours|Since each subject provided two blood glucose (BG) meter results, 2x74 (or 148) subject BG test results were possible. For each subject blood sample, a healthcare professional (HCP) provided two BG meter results so that 2x74 (or 148) BG results were possible for HCP test results.||Number of Duplicate Results (n=74x2)|||Number
783196|NCT00804596|Primary|Percentage of Participants Rated as <=3 (Comprehension of Labeling)|"Study staff rated participants on their success at performing Blood Glucose (BG) testing and other system features after subjects read product labeling. The rating scale was:
Successful in performing tasks correctly without assistance
Successful after being referred to user instructions
Successful after verbal assistance or review of part of user instructions (Similar to review of a specific function during a Customer Service call.)
Unsuccessful (Incorrectly performed part of the testing regimen or required intervention by study staff.)"|1-2 hours|per protocol||percentage of participants|||Number
783199|NCT00804648|Secondary|Visual Acuity|The visual acuity score is a count of the number of letters the subject successfully read from the eye chart. The higher the score, the better the vision.|following 3 days of treatment|||number of letters||Standard Deviation|Mean
783200|NCT00804648|Secondary|Conjunctival Staining - Temporal Count|Assessed by investigator using a slit lamp and counting number of spots.|following 3 days of treatment|||number of spots||Standard Deviation|Mean
783201|NCT00804648|Secondary|Conjunctival Staining - Temporal Grade|Assessed by investigator using a slit lamp and Oxford Scheme, grading 0,1,2,3,4,5 according to pictures provided. The higher the grade the worse the staining.|following 3 days of treatment|||Units on a scale||Standard Deviation|Mean
783202|NCT00804648|Secondary|Conjunctival Staining - Nasal Count|Assessed by investigator using slit lamp and counting number of spots.|following 3 days of treatment|||number of spots||Standard Deviation|Mean
783203|NCT00804648|Secondary|Conjunctival Staining - Nasal Grade|Assessed by investigator using a slit lamp and the Oxford Scheme, grading 0,1,2,3,4,5 according to pictures provided. The higher the grade the worse the staining.|following 3 days of treatment|||Units on a scale||Standard Deviation|Mean
783204|NCT00804648|Secondary|Basic Schirmer's|Schirmer's measures basic tear function. The higher the number, the less dry the eye.|following 3 days of treatment|||mm of moisture||Standard Deviation|Mean
783205|NCT00804648|Secondary|Intraoclular Pressure||following 3 days of treatment|||mm of mercury||Standard Deviation|Mean
783206|NCT00804648|Secondary|Corneal Staining Count|Assessed by the investigator using a slit lamp, counting the number of spots.|following 3 days of treatment|||Number of spots||Standard Deviation|Mean
783207|NCT00804648|Secondary|Corneal Staining Grade|Assessed by the investigator using a slit lamp and Oxford Scheme, grading 0,1,2,3,4,5. The higher the grade the worse the staining.|following 3 days of treatment|||Units on a scale||Standard Deviation|Mean
783208|NCT00804648|Secondary|Tear Film Break-up Time||following 3 days of treatment|||Seconds||Standard Deviation|Mean
783209|NCT00804648|Secondary|Conjunctival Hyperemia|Assessed by investigator using a slit lamp and a photographic grading scale. Photographs were graded: grade 0, grade 1, grade 2, grade 3. The higher the graded the worse the hyperemia.|following 3 days of treatment|||Units on a scale||Standard Deviation|Mean
783211|NCT00804687|Secondary|Change From Baseline in Minimal Cross-Sectional Area (MCA) at 1, 2, 3, 4, 5, 6, 7 and 8 Hours After Drug Administration at Day 1|The MCA was measured using AcR which is an objective measurement of nasal congestion that assesses nasal cavity geometry (that is, MCA) and changes in the dimensions of the nasal cavity. Change from Baseline in MCA is the value at particular time point minus value at Baseline.|Baseline, 1, 2, 3, 4, 5, 6, 7 and 8 hours after drug administration at Day 1 of each treatment period|The ITT population included all participants who received at least one dose of study medication and had at least one post-baseline AcR efficacy assessment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.||square centimeter (cm^2)||Standard Deviation|Mean
783212|NCT00804687|Secondary|Change From Baseline in Total Nasal Symptom Score (TNSS) at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5 and 8 Hours After Drug Administration at Day 1|The TNSS was the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Participants assessed each individual symptoms on a scale of 0-3 where: 0=absent, 1=mild, 2=moderate and 3=severe. TNSS score ranges from 0 to 12 and higher scores indicate worsening. Change from Baseline in TNSS is the value at particular time point minus value at Baseline.|0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5 and 8 hours after drug administration at Day 1 of each treatment period|The ITT population included all participants who received at least one dose of study medication and had at least one post-baseline AcR efficacy assessment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.||units on a scale||Standard Deviation|Mean
783213|NCT00804687|Secondary|Baseline Adjusted Area Under the Curve (AUC) of Total Nasal Symptom Score (TNSS)|The TNSS was the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Participants assessed each individual symptoms on a scale of 0-3 where: 0=absent, 1=mild, 2=moderate and 3=severe. TNSS score ranges from 0 to 12 and higher scores indicate worsening. The AUC of TNSS was used as response variable to assess the treatment effect. AUC was adjusted for Baseline TNSS scores. Baseline TNSS was defined as the symptom scores for each treatment period at pre-dose (approximately 2 hour before EEC entry).|2, 1.5, 1, 0.5 hour before drug administration and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5 and 8 hours after drug administration at Day 1 of each treatment period|The ITT population included all participants who received at least one dose of study medication and had at least one post-baseline AcR efficacy assessment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.||units on a scale * hours||Standard Deviation|Mean
783214|NCT00804687|Primary|Baseline Adjusted Area Under the Curve (AUC) of Minimal Cross-Sectional Area (MCA) of Nasal Cavity by Acoustic Rhinometry|The AcR was an objective measurement of nasal congestion that assessed nasal cavity geometry (that is, MCA) and changes in dimensions of nasal cavity. The AUC of MCA was used as response variable to assess treatment effect. AUC was adjusted for Baseline MCA scores. Baseline MCA was defined as minimum mean MCA at pre-dose (approximately 2 hours before Environmental Exposure Chamber [EEC] entry) resulting from 3 measurements on both, left and right nostrils in each of the treatment periods. The AUC of MCA was baseline-adjusted, by subtracting the Baseline value from each of the post-treatment times before calculating the AUC.|2 and 0.5 hour before drug administration and 1, 2, 3, 4, 5, 6, 7 and 8 hours after drug administration at Day 1 of each treatment period|Intent to treat (ITT) population included all participants who received at least one dose of study medication and had at least one post-baseline AcR efficacy assessment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.||square centimeter*hour (cm^2*h)||Standard Deviation|Mean
783215|NCT00804713|Other Pre-specified|TST Results for the Population for Which All 4 Tests Have Valid Results and no Borderline Results||48-72 hours after adminstration|||participants|||Number
783216|NCT00804713|Other Pre-specified|Battey Skin Test Result|Battey skin test positive results defined as >= 100 mm reaction. The number of subjects is 1781 (less than the original 1978) because we analyzed only those who had valid results by all 4 tests to have a fair comparison. Additionally, we excluded those subject who had a borderline T-Spot result, as we were not able to make valid comparisons with these results.|48-72 hours after administration|||participants|||Number
783217|NCT00804713|Other Pre-specified|T-Spot Result|Positive T-Spot results. The number of subjects is 1781 (less than the original 1978) because we analyzed only those who had valid results by all 4 tests to have a fair comparison. Additionally, we excluded those subject who had a borderline T-Spot result, as we were not able to make valid comparisons with these results.|48-72 hours|||participants|||Number
783218|NCT00804713|Secondary|Positive QFT-GIT Result|The number of subjects is 1781 (less than the original 1978) because we analyzed only those who had valid results by all 4 tests to have a fair comparison. Additionally, we excluded those subject who had a borderline T-Spot result, as we were not able to make valid comparisons with these results.|48-72 hours after enrollment|||participants|||Number
783219|NCT00804713|Primary|TST Induration Will be Interpreted Relative to Risk, in Accordance With Published CDC Guidelines.|"Risk stratification and test result. Risk was stratified by the use of risk factors identified by questionnaire according to the 5, 10 and 15 mm criteria (CDC Morbidity and Mortality Weekly Report Recommendations and Reports 2000. Targeted Testing for Latent Tuberculosis Infection.)
The number of 1803 is used here because that is the number for which valid results were available for all 4 tests.
The number presented in each category is the number of participants that had positive results.
We are only presented a risk stratified interpretation for the TST (not the QFT, T-spot, and BST) because that is the only test for which this methodology is accepted in scientific and medical use. It is also the only test for which we had pre-specified the use of this methodology in the protocol."|48-72 hrs post administration|||participants|||Number
783223|NCT00804908|Secondary|Time to Neurological/Brain Metastases Progression|Time to neurological/brain metastases progression, defined as the number of days from the date of randomization to the date the participant experienced an event of neurological/brain metastases progression, was estimated using Kaplan-Meier methodology. Point estimates and 95% CIs for the quartiles for the distribution are provided. All events of progression were included, regardless of whether the event occurred while the participant was still taking study drug. If a participant did not experience an event, data were censored at the date of the last available brain CT scan. For participants with no postbaseline brain CT scans, data were censored at randomization. Per protocol, because neither the ABT-888 20 mg BID + TMZ nor ABT-888 40 mg BID + TMZ groups were statistically significantly better than the Placebo + TMZ group for the primary endpoint of PFS, confirmatory statistical testing was not continued for any secondary endpoints, regardless of the observed P values.|Every 2 cycles (8 weeks) until disease progression was observed or another reason for discontinuation of assessments was identified by the investigator. The maximum observed followup duration at the progression-free survival analysis time was 9.7 months.|ITT population defined as all randomized participants.||days||95% Confidence Interval|Number
783224|NCT00804908|Secondary|Disease Control Rate|The disease control rate was defined as the percentage of participants who had at least stable disease (complete response, partial response, or stable disease) through the end of Week 8. Per protocol, because neither the ABT-888 20 mg BID + TMZ nor ABT-888 40 mg BID + TMZ treatment groups were statistically significantly better than the Placebo + TMZ treatment group for the primary endpoint of PFS, confirmatory statistical testing was not continued for any secondary endpoints, regardless of the observed P values.|Week 8|ITT population defined as all randomized participants.||percentage of participants||95% Confidence Interval|Number
783225|NCT00804908|Secondary|Time to Disease Progression|The distribution of time to disease progression, as determined by the central imaging center (radiological)/ investigator (clinical), was estimated for each treatment group using Kaplan-Meier methodology. Point estimates and 95% CIs for the quartiles for the PFS distribution are provided. Per protocol, because neither the ABT-888 20 mg BID + TMZ nor ABT-888 40 mg BID + TMZ treatment groups were statistically significantly better than the Placebo + TMZ treatment group for the primary endpoint of PFS, confirmatory statistical testing was not continued for any secondary endpoints, regardless of the observed P values.|Every Cycle (28 Days), until disease progression was observed or another reason for discontinuation of assessments was identified by the investigator. The maximum observed followup duration at the progression-free survival analysis time was 9.7 months.|ITT population defined as all randomized participants.||days||95% Confidence Interval|Number
783226|NCT00804908|Secondary|Objective Response Rate|The objective response rate was defined as the percentage of participants with a confirmed CR or PR per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by computed tomography (CT) scan: complete response (CR), disappearance of all target lesions; partial response (PR), ≥30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Per protocol, because neither the ABT-888 20 mg BID + TMZ nor ABT-888 40 mg BID + TMZ treatment groups were statistically significantly better than the Placebo + TMZ treatment group for the primary endpoint of PFS, confirmatory statistical testing was not continued for any secondary endpoints, regardless of the observed P values.|Every 2 cycles (8 weeks) until disease progression was observed or another reason for discontinuation of assessments was identified by the investigator. The maximum observed followup duration at the progression-free survival analysis time was 9.7 months.|All subjects in the ITT population (defined as all randomized participants) with measurable disease.||percentage of participants||95% Confidence Interval|Number
783227|NCT00804908|Secondary|6-month Progression-Free Survival Rate|The 6-month progression-free survival rate was defined as the percentage of participants without disease progression at 6 months.The distribution of 6-month progression-free survival rate, as determined by the central imaging center (radiological)/ investigator (clinical), was estimated using Kaplan-Meier methodology. Point estimates and 95% CIs for the quartiles for the PFS distribution are provided. Per protocol, because neither the ABT-888 20 mg BID + TMZ nor ABT-888 40 mg BID + TMZ treatment groups were statistically significantly better than the Placebo + TMZ treatment group for the primary endpoint of PFS, confirmatory statistical testing was not continued for any secondary endpoints, regardless of the observed P values.|Every Cycle (28 Days) until disease progression was observed or another reason for discontinuation of assessments was identified by the investigator. The maximum observed followup duration at the progression-free survival analysis time was 9.7 months.|ITT population defined as all randomized participants.||percentage of participants||95% Confidence Interval|Number
783228|NCT00804908|Secondary|12-Month Overall Survival (OS) Rate|The 12-month overall survival rate was defined as the percentage of participants surviving at 12 months. The distribution of 12-month OS rate was estimated using Kaplan-Meier methodology. Point estimates and 95% CIs for the quartiles for the PFS distribution are provided. Per protocol, because neither the ABT-888 20 mg BID + TMZ nor ABT-888 40 mg BID + TMZ treatment groups were statistically significantly better than the Placebo + TMZ treatment group for the primary endpoint of PFS, confirmatory statistical testing was not continued for any secondary endpoints, regardless of the observed P values.|Per protocol, survival was to be assessed every 4 weeks or as needed after participant is registered as off-study for up to 18 months. The maximum observed follow-up at the overall survival analysis time was 21.0 months.|ITT population defined as all randomized participants.||percentage of participants||95% Confidence Interval|Number
783229|NCT00804908|Secondary|Overall Survival (OS): Time to Event|OS was defined as the number of days from the date the participant was randomized to the date of death. All deaths were included, whether the participant was still taking or had discontinued study drug. If a participant had not died and was lost to follow-up, then data were censored at the last study visit or contact date, or date the participant was last known to be alive, whichever was later; if the participant was not lost to follow-up, then data were censored at the last study visit or contact date, whichever was later. The distribution of OS was estimated for each treatment group using Kaplan-Meier methodology. Point estimates and 95% CIs for the quartiles for the OS distribution are provided. Per protocol, because neither the ABT-888 20 mg BID + TMZ nor ABT-888 40 mg BID + TMZ groups were statistically significantly better than the Placebo + TMZ group for the primary endpoint of PFS, confirmatory statistical testing was not continued for any secondary endpoints.|Per protocol, survival follow-up information was to be obtained every 3 months for up to 18 months after the final visit for the subject. The maximum observed follow-up at the overall survival analysis time was 21.0 months.|ITT population defined as all randomized participants.||days||95% Confidence Interval|Number
783230|NCT00804908|Primary|Progression-Free Survival (PFS): Time to Event|PFS: the number of days from the date that the participant was randomized to the date the participant experienced a confirmed event of disease progression (radiological, as determined by the central imaging center; or clinical, as determined by the investigator), or to the date of death (all causes of mortality) if disease progression was not reached. All events were included whether the participant was still taking or had discontinued study drug. Events of death were included for participants who had not experienced a confirmed event of disease progression, provided the death occurred within 8 weeks of the last available disease progression assessment. The distribution of PFS, as determined by the central imaging center (radiological)/ investigator (clinical), was estimated for each treatment group using Kaplan-Meier methodology. Point estimates and 95% confidence intervals (95% CIs) for the quartiles for the PFS distribution are provided.|Every Cycle (28 Days) until disease progression was observed or another reason for discontinuation of assessments was identified by the investigator. The maximum observed followup duration at the progression-free survival analysis time was 9.7 months.|ITT population defined as all randomized participants.||days||95% Confidence Interval|Number
783231|NCT00804986|Secondary|Percent of Participants Domain Scores Indicating No Problems on European Quality of Life (EuroQol) at Baseline and Week 12 Endpoint|The EuroQoL Questionnaire – 5 Dimension (EQ-5D) is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 is generated for each domain. For each participant, the outcome rating on the 5 domains will be mapped to a single index through an algorithm. The index ranges between 0 and 1, with the higher score indicating a better health state perceived by the participant.|Baseline, 12 Weeks|||percentage of participants|||Number
783232|NCT00804986|Secondary|Change in European Quality of Life (EuroQol)- Visual Analog Scale From Baseline to Week 12 Endpoint|Participant chooses where they think their current health state lies on a 10 centimeter line between two anchors (0 - worst imaginable health state and 10 - best imaginable health state). The possible range of scores is 0 to 100 and represents millimeters on the 10 centimeter line. A higher score is associated with better health state. LSMean adjusted for baseline, baseline HbA1c (less than 8.5% versus greater than or equal to 8.5%), metformin use, treatment.|baseline, 12 weeks|Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement, last observation carried forward (LOCF) up to visit 9 (week 12)||millimeters||Standard Error|Least Squares Mean
783233|NCT00804986|Secondary|Change in Diabetes Symptom Checklist-Revised (DSC-R) Average Score From Baseline to Week 12 Endpoint|DSC-R assesses the presence and perceived burden of diabetes-related symptoms using the following subscales: hypoglycemic, hyperglycemic, psychological, cardiovascular, neurological, ophthalmological. Participants evaluate symptoms based on a 5-point Likert-type scale, ranging from 1=not at all troublesome to 5=extremely troublesome. Higher scores indicated greater severity of symptoms within a domain, or poorer perceived health, respectively. LSMean adjusted for baseline, baseline HbA1c (less than 8.5% versus greater than or equal to 8.5%), metformin use, treatment.|baseline, 12 weeks|Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement, last observation carried forward (LOCF) up to visit 9 (week 12)||units on a scale||Standard Error|Least Squares Mean
783234|NCT00804986|Secondary|Change in Impact of Weight on Quality of Life - Lite (IWQoL-Lite) Average Score From Baseline to Week 12 Endpoint|Impact of Weight on Quality of Life (IWQoL) - Lite Version consists of 31 items from 5 subscales: physical functioning, self-esteem, sexual life, public distress, and work as well as a total score. Individual item scoring ranges from 0 (never true) to 4 (always true) with total score range from 0 to 124. Higher scores on the subscales and total score correspond with lower levels of functioning or greater negative effect. LSMean adjusted for baseline, baseline HbA1c (less than 8.5% versus greater than or equal to 8.5%), metformin use, treatment.|baseline, 12 weeks|Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement, last observation carried forward (LOCF) up to visit 9 (week 12)||units on a scale||Standard Error|Least Squares Mean
783235|NCT00804986|Secondary|Change in Fasting Weight From Baseline to Week 12 Endpoint|LSMean adjusted for baseline, treatment, visit, treatment-by-visit interaction.|baseline, 12 weeks|Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement.||kilograms (kg)||95% Confidence Interval|Least Squares Mean
783236|NCT00804986|Secondary|Change in Fasting Lipids From Baseline to Week 12 Endpoint|Fasting lipids were measured after overnight fasting of at least 8 hours. Lipids analyzed include triglycerides, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and total-cholesterol. LSMean adjusted for baseline and treatment.|baseline, 12 weeks|Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement. The last post-baseline measurement was carried forward if the value at week 12 was missing.||millimole per liter (mmol/L)||Standard Error|Least Squares Mean
783237|NCT00804986|Secondary|Change in C-peptide Area Under the Curve (AUC) From Baseline to Week 12 Endpoint|An oral glucose tolerance test (OGTT) was used to assess changes in insulin secretory response. The area under the C-peptide concentration versus time curve was calculated using the linear-trapezoidal method. Area under the curve (AUC) for C-peptide represents the area that is under the curve of C-peptide values when they are plotted over time. Larger AUC values represent a greater average C-peptide value over time. LSMean adjusted for baseline, treatment, visit, treatment-by-visit interaction.|baseline, 12 weeks|Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement.||picomole per minute per liter||95% Confidence Interval|Least Squares Mean
783238|NCT00804986|Secondary|Change in Insulin Total Area Under the Curve (AUC) From Baseline to Week 12 Endpoint|An oral glucose tolerance test (OGTT) was used to assess changes in insulin secretory response. The area under the insulin concentration versus time curve was calculated using the linear-trapezoidal method. Area under the curve (AUC) for insulin represents the area that is under the curve of insulin values when they are plotted over time. Larger AUC values represent a greater average insulin value over time. LSMean adjusted for baseline, treatment, visit, treatment-by-visit interaction.|baseline, 12 weeks|Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement.||picomole per minute per liter||95% Confidence Interval|Least Squares Mean
783239|NCT00804986|Secondary|Change in Total Glucose Area Under the Curve (AUC) From Baseline to Week 12 Endpoint|An oral glucose tolerance test (OGTT) was used to assess changes in glucose tolerance. The area under the plasma glucose concentration versus time curve was calculated using the linear-trapezoidal method. Area under the curve (AUC) for glucose represents the area that is under the curve of glucose values when they are plotted over time. Larger AUC values represent a greater average glucose value over time. LSMean adjusted for baseline, treatment, visit, treatment-by-visit interaction.|baseline, 12 weeks|Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement.||milligrams per minute per deciliter||95% Confidence Interval|Least Squares Mean
783240|NCT00804986|Secondary|Change in 7-Point Self-Monitored Glucose From Baseline to Week 12 Endpoint|Self-monitored glucose levels measured at 7 timepoints during the day. Timepoints include: fasting pre-breakfast, 2 hours post breakfast, prior to lunch, 2 hours post lunch, prior to dinner, 2 hours post dinner, and prior to bed. LSMean adjusted for baseline, treatment, visit, treatment-by-visit interaction.|baseline, 12 weeks|Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement.||milligrams per deciliter (mg/dL)||95% Confidence Interval|Least Squares Mean
783241|NCT00804986|Secondary|Total Average Concentration (Cavg) of LY2428757|Average concentration (Cavg) is calculated as the AUC0-168 (area under the plasma concentration vs. time curve during one dosing interval of 168 hours) divided by 168 hours. The numbers presented reflect the average LY2428757 drug concentration circulating in the body over 168 hours (one dosing interval).|4 weeks, 6 weeks, 8 weeks, 10 weeks|All randomized participants||nanograms per milliliter (ng/mL)|||Number
783242|NCT00804986|Secondary|Number of Participants With Detectable Antibodies To LY2428757 At Any Time During The Study|Blood samples were collected from all randomized participants to test for the development of antibodies binding to LY2428757. If a participant developed a positive anti-LY2428757 antibody titer, appropriate medical management was to be utilized at the discretion of the sponsor and investigator, if deemed necessary.|baseline through 16 weeks|All randomized participants||participants|||Number
783243|NCT00804986|Secondary|Change in Visual Analogue Scales (VAS) For Appetite and Satiety From Baseline to Week 12 Endpoint|The VAS scales for appetite (hunger) and satiety (how full) were recorded on a scale with range of possible scores from 0 to 100 represented in millimeters on a 10 centimeter line. For appetite, participant chooses where they think their appetite lies on a 10 centimeter line between two anchors (0 - not at all hungry and 10 - extremely hungry). For satiety, participant chooses where they think their satiety lies on a 10 centimeter line between two anchors (0 - not at all full and 10 - extremely full). LSMean adjusted for baseline, treatment, visit, treatment-by-visit interaction.|baseline, 12 weeks|Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement.||millimeters (mm)||Standard Error|Least Squares Mean
783244|NCT00804986|Primary|Change in Hemoglobin A1C (HbA1c) From Baseline to Week 12 Endpoint|LSMean adjusted for baseline HbA1c, metformin use, treatment, visit, treatment-by-visit interaction.|baseline, 12 weeks|Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement.||percentage of glycosylated hemoglobin||95% Confidence Interval|Least Squares Mean
783245|NCT00805025|Secondary|Responsiveness of the Respiratory Domain of the QOL-B as Assessed by the Anchor-based Minimal Clinically Important Difference (MCID) Following Categorization of Level of Change Using the Global Rating of Change Questionnaire (GRCQ)|"The anchor-based method measured the participant's perception of change at Day 28 using the GRCQ, which assesses improving/worsening symptoms. Distribution of ratings was categorized as no change (-1 to 1), minimal change (≥ 1.1 to < 3.1 or ≤ -1.1 to > -3.1), moderate change (≥ 3.1 to < 5.1 or ≤ -3.1 to > -5.1) or large change (≥ 5.1, ≤ -5.1). The GRCQ evaluated change in respiratory symptoms on a visual analog scale from -7 (worsening) to +7 (improvement). The following algorithm was used to obtain the mean change:
If the corresponding GRCQ score was in the “no change” group, then change from baseline QOL-B = Observed QOL-B change from baseline score; if > 1, then change from baseline QOL-B score = Observed QOL-B change from baseline score; if < -1, the change from baseline QOL-B score = (-1) * Observed QOL-B change from baseline score.
Then the mean change from baseline of QOL-B respiratory symptoms score of the minimal change category group is the anchor-based MCID."|Day 0 to Day 28|Participants who were evaluable for MCID and had both GRCQ and QOL-B change values at Day 28 (Visit 4) in any GRCQ domain were analyzed.||units on a scale||Standard Deviation|Mean
783246|NCT00805025|Primary|Convergent Validity of the Respiratory Domain of the QOL-B|Convergent validity was assessed at Day -14 by examining the correlations between relevant QOL-B domains and other indicators of health status: a bronchiectasis severity score based on high-resolution computerised tomography (HRCT) scan results, forced expiratory volume in 1 second (FEV1) percent predicted, 6-minute walk test (6MWT) results, and St. George's Respiratory Questionnaire (SGRQ) symptoms scores. Correlations with absolute values of 0.30 to 0.50 indicated moderate evidence of convergent validity.|Day -14|Participants were analyzed for respiratory domain score at Day 0 against each of the other variables; those with data for both the respiratory domain score and each variable are reported.||Pearson correlation coefficient|||Number
783247|NCT00805025|Primary|Reliability of the Respiratory Domain of the Quality of Life Questionnaire-Bronchiectasis (QOL-B)|"Test-retest reliability is a measure of the stability or reproducibility of a measure over a period of time during which status on the underlying construct has not changed, and is measured by the intraclass correlation of scores obtained at 2 time points within that period. Test-retest reliability of respiratory symptoms was calculated for response at Day -14 and Day 0. Reliability of the participants' QOL-B responses was assessed from an Intraclass Correlation Coefficient (ICC). A score of ≥ 0.70 would indicate strong reliability.
The QOL-B respiratory symptoms score was transformed onto a scale of 0-100, with higher scores representing a better quality of life."|Day -14 to Day 0|Participants who were treated and had any QOL-B measurements at both Screening and Day 0 (Visits 1 and 2) were analyzed.||Intraclass Correlation Coefficient|||Number
783248|NCT00805038|Secondary|Impediments to Successful Intervention||18-24 months||||||
783249|NCT00805038|Primary|Number of Steps Completed in Transplant Process|Many kidney failure patients, particularly minorities and women, face barriers in completing the steps required to obtain a transplant. These sequential steps include: medical suitability, interest in transplant, referral to a transplant center, first visit to center, transplant workup, successful candidate, waiting list or identify living donor, and receive transplant. We calculated the number of transplant process steps completed by both groups.|18-24 months|ITT analysis. Last observation carried forward for preliminary analyses.||steps per participant||95% Confidence Interval|Mean
783250|NCT00805142|Secondary|Patient’s Global Impression of Change (PGI-C)|PGI-C is a participant rated instrument to measure participant's change in overall status of general condition including pain on a 7-point scale; range from 1 (very much improved) to 7 (very much worse).|Day 19|The PPS included all participants enrolled excluding those with a major protocol violation. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure.||participants|||Number
783251|NCT00805142|Secondary|Sleep Questionnaire Regarding the Quality of Sleep|The sleep questionnaire is a 4-item questionnaire evaluating the condition of the sleep of the participant on the previous night. Participants rated overall sleep quality on a scale ranging from excellent to very poor.|Pre-dose (Day 1) and Day 20|The PPS included all participants enrolled excluding those with a major protocol violation. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure.||participants|||Number
783252|NCT00805142|Secondary|Sleep Questionnaire Regarding Number of Awakenings|The sleep questionnaire is a 4-item questionnaire evaluating the condition of the sleep of the participant on the previous night . Participants were asked to provide the number of times they awoke at night.|Pre-dose (Day 1) and Day 20|The PPS included all participants enrolled excluding those with a major protocol violation. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure.||awakenings||Standard Deviation|Mean
783253|NCT00805142|Secondary|Sleep Questionnaire Regarding Time to Sleep and Total Time Slept|The sleep questionnaire is a 4-item questionnaire evaluating the condition of the sleep of the participant on the previous night. The participants were asked about the time taken by them to fall asleep previous night after bedtime and the total time they slept during previous night.|Pre-dose (Day 1) and Day 20|THe PPS included all participants enrolled excluding those with a major protocol violation. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure.||minutes||Standard Deviation|Mean
783254|NCT00805142|Secondary|Number of Participants Who Discontinued Study Treatment Because of Any Adverse Event (AE) or Lack of Efficacy|The AE is an undesirable or unwanted consequence that occurred during the course of the clinical trial, but not necessarily because of study drug.The AEs included the onset of new symptoms, worsening of the frequency or severity of the symptom compared with Baseline, and abnormal findings including abnormal laboratory test values in the diagnostic examination. The participants who discontinued because of lack of efficacy were those in which satisfactory analgesia was not maintained.|Baseline up to 7 days after last dose of study treatment|The PPS included all participants enrolled excluding those with a major protocol violation.||participants|||Number
783255|NCT00805142|Secondary|Rescue Doses|The immediate release (IR) oral opioids were used as rescue doses in the participants with lack of efficacy or to have relief from severe pain. In case of opioid-switching participants rescue doses were continued without any change in the preceding doses or the type throughout the study. The IR morphine HCl was used as the rescue dose for opioid-naive participants. The upper limit of rescue doses was specified for each daily dose of tapentadol PR. There was no change in the dose of rescue medication during maintenance period for opioid-naive participants.|Day 12, 13, 14, 15, 16, 17, 18 and 19|The PPS included all participants enrolled excluding those with a major protocol violation. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure.||mg per day||Standard Deviation|Mean
783256|NCT00805142|Secondary|Pain Assessment Using Visual Analog Scale (VAS) Score|Pain VAS assesses the pain intensity experienced by the participant on a 100 millimeter (mm) VAS, where responses range from a response of no pain (score of 0 mm) to severest pain imaginable (score of 100 mm). The participant indicated the pain by marking the applicable place with slash (/) and the investigator then measured the length from left edge to the slash.|Baseline and Day 19|The PPS included all participants enrolled excluding those with a major protocol violation. Missing values were imputed using last observed carried forward (LOCF) method.||mm||Standard Deviation|Mean
783257|NCT00805142|Secondary|Pain Assessment Using 24-hour Numerical Rating Scores (NRS) Scale|Pain intensity scores were measured on 11 point NRS, where 0 = no pain and 10 = severest pain imaginable. The pain intensity at Baseline was the average of scores on two consecutive morning doses (Day -1 and Day 0) and on Day 20 only a single observation was recorded.|Baseline (Average of Day -1 and Day 0 morning scores), Day 20|The PPS included all participants enrolled excluding those with a major protocol violation.||units on a scale||Standard Deviation|Mean
783258|NCT00805142|Secondary|Percentage of Participants Who Achieve Dose Adjustment|Percentage of participants who achieved dose adjustment included those participants whose dose was adjusted during the titration period period and entered the fixed dose maintenance period. Titration period (3-14 days) was the duration between start of treatment to the day before the initial dose in the maintenance period. Maintenance period (15-19 days) was the duration between the first dose and the final assessment in the maintenance period.|Day 3 up to Day 14|The PPS included all participants enrolled excluding those with a major protocol violation.||percentage of participants||95% Confidence Interval|Number
783259|NCT00805142|Primary|Percentage of Participants With Sustained Pain Control for 5 Day Fixed Dose Phase|Percentage of participants with sustained pain control for 5 day fixed dose phase were the participants who completed 5 day maintenance period, whose mean Numerical Rating Scale (NRS) score during the fixed dose phase and which was assessed immediately before giving each dose was less than 4 and the number of rescue doses per day for fixed dose phase was 2 or less. Pain intensity scores were recorded 0 to 30 minutes before dose on 11 point NRS where 0 = no pain and 10 = severest pain imaginable.|Day 15 up to Day 19|Per protocol set (PPS) included all participants enrolled excluding those with a major protocol violation. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure.||percentage of participants||95% Confidence Interval|Number
783274|NCT00805285|Secondary|C Reactive Protein|Higher values indicated increased disease activity|Week 0 and 8||||||
783275|NCT00805285|Secondary|Adverse Events||0, 2, 4, 6, 8, 11, 14, 20, 26, and 52 weeks|||Adverse events|||Number
783276|NCT00805285|Secondary|ACTH Stimulation Test|An increase in cortisol after stimulation by ACTH is normal. Blood cortisol after ACTH stimulation should be greater than 18 - 20 mcg/dL, depending on the dose of cosyntropin used.|Week 16||||||
783277|NCT00805285|Primary|Short Inflammatory Bowel Disease Questionnaire (SIBDQ)|Scores range from 10-70 where higher scores indicated better quality of life.|Week 0 and 8||||||
783278|NCT00805285|Primary|Simple Clinical Colitis Disease Activity (SCCAI)|Scores range from 0-19. Higher scores indicated increased disease severity. A score less than 3 is consistent with clinical remission.|0, 2, 4, 6, and 8 weeks||||||
783279|NCT00805389|Secondary|Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR)|The analysis of the mRNA levels of 14 target genes was performed using whole blood, in the first 140 subjects from the 2 subsets recruited at the Immune Health (IH) centre in La Louvière, Belgium, by microarray/ Polymerase Chain Reaction (PCR) array/ quantitative PCR. Among the target genes were Nuclear Factor Of Activated T-Cells, Cytoplasmic, Calcineurin-Dependent 2 (NFATC2) and Interferon-gamma (IFN-γ).|At Days 0, 1, 14, 30, 31, 33 and 37|The ATP cohort for innate immunogenicity up to Day 60 included all evaluable subjects, who complied with the vaccination schedule, for whom data concerning immunogenicity outcome measures were available and for whom innate immunogenicity data were available for at least one post-vaccination time point.||cells/mL||Full Range|Median
783280|NCT00805389|Secondary|Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR)|The analysis of the mRNA levels of 14 target genes was performed using whole blood, in the first 140 subjects from the 2 subsets recruited at the Immune Health (IH) centre in La Louvière, Belgium, by microarray/ Polymerase Chain Reaction (PCR) array/ quantitative PCR. Among the target genes were Prostaglandin-Endoperoxide Synthase 2 (PTGS2), Dual Specificity Phosphatase 1 (DUSP1).|At Days 0, 1, 14, 30, 31, 33 and 37|The ATP cohort for innate immunogenicity up to Day 60 included all evaluable subjects, who complied with the vaccination schedule, for whom data concerning immunogenicity outcome measures were available and for whom innate immunogenicity data were available for at least one post-vaccination time point.||cells/mL||Full Range|Median
783281|NCT00805389|Secondary|Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR)|The analysis of the mRNA levels of 14 target genes was performed using whole blood, in the first 140 subjects from the 2 subsets recruited at the Immune Health (IH) centre in La Louvière, Belgium, by microarray/ Polymerase Chain Reaction (PCR) array/ quantitative PCR. Among the target genes were Chemokine Ligand 10 (CXCL10), Interleukin-1B (IL-1B).|At Days 0, 1, 14, 30, 31, 33 and 37|The ATP cohort for innate immunogenicity up to Day 60 included all evaluable subjects, who complied with the vaccination schedule, for whom data concerning immunogenicity outcome measures were available and for whom innate immunogenicity data were available for at least one post-vaccination time point.||cells/mL||Full Range|Median
783282|NCT00805389|Secondary|Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR)|The analysis of the mRNA levels of 14 target genes was performed using whole blood, in the first 140 subjects from the 2 subsets recruited at the Immune Health (IH) centre in La Louvière, Belgium, by microarray/ Polymerase Chain Reaction (PCR) array/ quantitative PCR. Among the target genes were Interleukin-12A (IL-12A), Marker Of Proliferation Ki-67 (MKI67).|At Days 0, 1, 14, 30, 31, 33 and 37|The ATP cohort for innate immunogenicity up to Day 60 included all evaluable subjects, who complied with the vaccination schedule, for whom data concerning immunogenicity outcome measures were available and for whom innate immunogenicity data were available for at least one post-vaccination time point.||cells/mL||Full Range|Median
783283|NCT00805389|Secondary|Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR)|The analysis of the mRNA levels of 14 target genes was performed using whole blood, in the first 140 subjects from the 2 subsets recruited at the Immune Health (IH) centre in La Louvière, Belgium, by microarray/ Polymerase Chain Reaction (PCR) array/ quantitative PCR. Among the target genes were Interferon Regulatory Factor 1 (IRF1), MX Dynamin-Like GTPase 1(MX1).|At Days 0, 1, 14, 30, 31, 33 and 37|The ATP cohort for innate immunogenicity up to Day 60 included all evaluable subjects, who complied with the vaccination schedule, for whom data concerning immunogenicity outcome measures were available and for whom innate immunogenicity data were available for at least one post-vaccination time point.||cells/mL||Full Range|Median
785576|NCT00838162|Secondary|Maximum Plasma Concentration (Cmax) of TMC310911||Day 1 and Day 14|Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC310911)||ng/mL||Standard Deviation|Mean
783284|NCT00805389|Secondary|Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR)|The analysis of the mRNA levels of 14 target genes was performed using whole blood, in the first 140 subjects from the 2 subsets recruited at the Immune Health (IH) centre in La Louvière, Belgium, by microarray/ Polymerase Chain Reaction (PCR) array/ quantitative PCR. Among the target genes were Fas associated factor 1 (FAF1), Signal Transducer And Activator Of Transcription 1(STAT1).|At Days 0, 1, 14, 30, 31, 33 and 37|The ATP cohort for innate immunogenicity up to Day 60 included all evaluable subjects, who complied with the vaccination schedule, for whom data concerning immunogenicity outcome measures were available and for whom innate immunogenicity data were available for at least one post-vaccination time point.||cells/mL||Full Range|Median
783285|NCT00805389|Secondary|Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR)|The analysis of the mRNA levels of 14 target genes was performed using whole blood, in the first 140 subjects from the 2 subsets recruited at the Immune Health (IH) centre in La Louvière, Belgium, by microarray/ Polymerase Chain Reaction (PCR) array/ quantitative PCR. Among the target genes were Tumor Necrosis Factor (TNF), Tumor Necrosis Factor Receptor Superfamily (TNFRSF9).|At Days 0, 1, 14, 30, 31, 33 and 37|The ATP cohort for innate immunogenicity up to Day 60 included all evaluable subjects, who complied with the vaccination schedule, for whom data concerning immunogenicity outcome measures were available and for whom innate immunogenicity data were available for at least one post-vaccination time point.||cells/mL||Full Range|Median
783286|NCT00805389|Secondary|Gene Expression Signature Related to the Immune Response to the GSK223192A, Fendrix™ and Engerix-B™ Vaccines.|Gene expression signature related to the immune response to the GSK223192A, Fendrix™ and Engerix-B™ vaccines will be measured by microarray/Polymerase Chain Reaction (PCR) array/quantitative PCR, using whole blood. This outcome will be assessed in the first 140 subjects in Subsets 1 and 2 recruited at the Immune Health (IH) Centre in La Louvière, Belgium. Results for this outcome measure will be posted when available.|At Days 0, 0+ (Day 0 + 3 to 6 hours), 1, 30, 30+ (Day 30 + 3 to 6 hours), 31, 33 and 37.||12/2050||||
783287|NCT00805389|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs) and SAEs Related to Study Vaccination|A SAE was defined as a medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = occurrence of SAE(s) in a subject regardless of assessment of relationship to study vaccination. Related SAE(s) = occurrence of occurrence of SAE(s) in a subject assessed by the investigators as causally related to the study vaccination.|During the entire study period, from Day 0 to study end, at Day 360 for subjects not in Subsets 1 & 2 and at Day 390 for subjects in Subsets 1 & 2.|Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects.||Participants|||Count of Participants
783288|NCT00805389|Secondary|Number of Subjects Reporting Any and Related Adverse Events of Specific Interest (AESIs)|AESIs included Autoimmune Disease (AID), neurological/demyelinating events, rheumatic and connective diseases, autoimmune endocrine diseases, inflammatory bowel diseases, autoimmune blood disorders, inflammatory skin disorders, and other autoimmune/inflammatory events. Any AESI(s) = occurrence of any AESI(s) in a subject regardless of assessment of relationship to study vaccination. Related AESI(s) = Occurrence of AESI(s) in a subject assessed by the investigator as causally related to the study vaccination.|During the entire study period, from Day 0 to study end, at Day 360 for subjects not in Subsets 1 & 2 and at Day 390 for subjects in Subsets 1 & 2.|Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects.||Participants|||Count of Participants
783289|NCT00805389|Secondary|Number of Subjects Reporting Any, Grade 3 and/or Related Unsolicited Adverse Events (AEs) Following Booster Vaccination|An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an AE regardless of intensity grade or relationship to study vaccination. Grade 3 = occurrence of an AE that prevented normal activity. Related = occurrence of an AE assessed by the investigators as causally related to the study vaccine. This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.|Within the 31-day (Days 0-30) follow up period following booster vaccination with HBsAg antigens|Analysis was done on the Booster Total Vaccinated cohort which included all HLA Subsets 1 and 2 subjects who received the booster dose of HBsAg.||Participants|||Count of Participants
783290|NCT00805389|Secondary|Number of Subjects Reporting Any, Grade 3 and/or Related Unsolicited Adverse Events (AEs) Following Primary Vaccination|An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an AE regardless of intensity grade or relationship to study vaccination. Grade 3 = occurrence of an AE that prevented normal activity. Related = occurrence of an AE assessed by the investigators as causally related to the study vaccine.|Within the 31-day (Days 0-30) follow up period following primary vaccination with the GSK223192A, Fendrix™ or Engerix-B™ vaccine|Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects.||Participants|||Count of Participants
783291|NCT00805389|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination.|Solicited general symptoms assessed were Fatigue, Fever – oral temperature equal to or above (>=) 37.5 degrees Celsius (°C) –, Gastrointestinal symptoms (Gastr.), Headache, Malaise and Myalgia. Any = occurrence of a general symptom regardless of its intensity grade or relationship to vaccination. Related = occurrence of a general symptom assessed by the investigator to be causally related to vaccination. Grade 3 fever = oral temperature above (>) 39.0 °C. Grade 3 for Gastr., Headache, Malaise and Myalgia = occurrence of the specified solicited general symptom which prevented normal activity. This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.|Within the 7-day (Days 0-6) follow up period following booster vaccination with HBsAg antigens|Analysis was done on the Booster Total Vaccinated cohort which included all HLA Subsets 1 and 2 subjects who received the booster dose of HBsAg, on subjects for whom results were available for the timepoint/outcome analyzed.||Participants|||Count of Participants
783292|NCT00805389|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Booster Vaccination.|Solicited local symptoms assessed were pain, redness and swelling. All solicited local symptoms were considered as related to study vaccination. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling above (>) 50 millimeters (mm). Occurrence of a solicited local symptoms collected post-vaccination was a priori considered as related to vaccination. This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.|Within the 7-day (Days 0-6) follow up period following booster vaccination with HBsAg antigens|Analysis was done on the Booster Total Vaccinated cohort which included all HLA Subsets 1 and 2 subjects who received the booster dose of HBsAg, on subjects for whom results were available for the timepoint/outcome analyzed.||Participants|||Count of Participants
783293|NCT00805389|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination.|Solicited general symptoms assessed were Fatigue, Fever – oral temperature equal to or above (>=) 37.5 degrees Celsius (°C) –, Gastrointestinal symptoms (Gastr.), Headache, Malaise and Myalgia. Any = occurrence of a general symptom regardless of its intensity grade or relationship to vaccination. Related = occurrence of a general symptom assessed by the investigator to be causally related to vaccination. Grade 3 fever = oral temperature above (>) 39.0 °C. Grade 3 for Gastr., Headache, Malaise and Myalgia = occurrence of the specified solicited general symptom which prevented normal activity.|Within the 14-day (Days 0-13) follow up period following primary vaccination with the GSK223192A, Fendrix™ or Engerix-B™ vaccine.|Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, with analysis performed solely on subjects with results from post-primary vaccination available.||Participants|||Count of Participants
783294|NCT00805389|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Primary Vaccination.|Solicited local symptoms assessed were pain, redness and swelling. All solicited local symptoms were considered as related to study vaccination. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling above (>) 50 millimeters (mm). Occurrence of a solicited local symptoms collected post-vaccination was a priori considered as related to vaccination.|Within the 14-day (Days 0-13) follow up period following primary vaccination with the GSK223192A, Fendrix™ or Engerix-B™ vaccines.|Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, with analysis performed solely on subjects with results from post-primary vaccination available.||Participants|||Count of Participants
783295|NCT00805389|Secondary|Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase|Subjects were assessed with regard to their normal (Nor.) and abnormal (Abn.) levels for the above parameters of red blood cells (RBC), platelets (PLA), haemoglobin (HGB), alanine aminotransferase (ALT), aspartate aminotransferase (AST), serum creatinine (S-CREA), urea and lactate dehydrogenase (LDH) at the Day 360 baseline versus their status post vaccination (Day 390). This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.|At Days 360 and 390.|Analysis was done on the Booster Total Vaccinated cohort which included all HLA Subsets 1 and 2 subjects who received the booster dose of HBsAg.||Participants|||Count of Participants
783296|NCT00805389|Secondary|Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase|Subjects were assessed with regard to their normal (Nor.) and abnormal (Abn.) levels for the above parameters of red blood cells (RBC), platelets (PLA), haemoglobin (HGB), alanine aminotransferase (ALT), aspartate aminotransferase (AST), serum creatinine (S-CREA), urea and lactate dehydrogenase (LDH) at the Day 0 baseline versus their status post vaccination (Day 180 or 360). Day 180 or 360 results were chosen based on assessment of grading of the abnormality observed, with results for higher grading being tabulated.|post vaccination (up to Day 360).|Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.||Participants|||Count of Participants
783297|NCT00805389|Secondary|Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase|Subjects were assessed with regard to their normal (Nor.) and abnormal (Abn.) levels for the above parameters of red blood cells (RBC), platelets (PLA), haemoglobin (HGB), alanine aminotransferase (ALT), aspartate aminotransferase (AST), serum creatinine (S-CREA), urea and lactate dehydrogenase (LDH) at the Day 0 baseline versus their status post vaccination (Day 60).|At Day 0 and up to Day 60.|Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.||Participants|||Count of Participants
783298|NCT00805389|Secondary|Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase.|Subjects were assessed with regard to their normal (Nor.) and abnormal (Abn.) levels for the above parameters of white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), C-reactive protein (CRP) and creatine phosphokinase (CPK) at the Day 360 baseline versus their status post vaccination (Day 390). This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.|At Days 360 and 390.|Analysis was done on the Booster Total Vaccinated cohort which included all HLA Subsets 1 and 2 subjects who received the booster dose of HBsAg.||Participants|||Count of Participants
783299|NCT00805389|Secondary|Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase.|Subjects were assessed with regard to their normal (Nor.) and abnormal (Abn.) levels for the above parameters of white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), C-reactive protein (CRP) and creatine phosphokinase (CPK) at the Day 0 baseline versus their status post vaccination (Day 180 or 360). Day 180 or 360 results were chosen based on assessment of grading of the abnormality observed, with results for higher grading being tabulated.|Post vaccination (up to Day 360)|Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.||Subjects|||Number
783300|NCT00805389|Secondary|Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase.|Subjects were assessed with regard to their normal (Nor.) and abnormal (Abn.) levels for the above parameters of white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), C-reactive protein (CRP) and creatine phosphokinase (CPK) at the Day 0 baseline versus their status post vaccination (Day 60). This outcome measure concerns all subjects except subjects part of the HLA Subsets 1 and 2.|At Day 0 and up to Day 60.|Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.||Participants|||Count of Participants
783301|NCT00805389|Secondary|Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase.|Subjects were assessed with regard to their normal (Nor.) and abnormal (Abn.) levels for the above parameters of white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), C-reactive protein (CRP) and creatine phosphokinase (CPK) at the Day 0 baseline versus their status post vaccination (Day 60). This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.|At Day 0 and up to Day 60.|Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.||Participants|||Count of Participants
783302|NCT00805389|Secondary|Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase|Analysis of levels of serum creatinine (S-CREA), urea and lactate dehydrogenase (LDH) were assessed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. Levels are presented as normalized levels vs. the IH center. Normalization was performed as follows: (Raw result – lower limit normal (LLN) at the IH center) divided by (Upper Limit Normal (ULN) at the IH center minus LLN at the IH center). This outcome measure presents the raw data collected in absolute count, expressed in IH Center normalized levels based on absolute count data (IH normalized abs. count).|At Days 0, 30, 37 and 60.|Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.||cells/mL||Inter-Quartile Range|Median
783303|NCT00805389|Secondary|Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase|Analysis of levels of haemoglobin (Hgb), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were assessed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. Levels are presented as normalized levels vs. the IH center. Normalization was performed as follows: (Raw result – lower limit normal (LLN) at the IH center) divided by (Upper Limit Normal (ULN) at the IH center minus LLN at the IH center). This outcome measure presents the raw data collected in absolute count, expressed in IH Center normalized levels based on absolute count data (IH normalized abs. count).|At Days 0, 30, 37 and 60.|Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.||cells/mL||Inter-Quartile Range|Median
783304|NCT00805389|Secondary|Normalized Levels of Red Blood Cells and Platelets|Analysis of levels of red blood cells (RBC) and platelets (PLA) were assessed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. Levels are presented as normalized levels vs. the IH center. Normalization was performed as follows: (Raw result – lower limit normal (LLN) at the IH center) divided by (Upper Limit Normal (ULN) at the IH center minus LLN at the IH center). This outcome measure presents the raw data collected in absolute count, expressed in IH Center normalized levels based on absolute count data (IH normalized abs. count).|At Days 0, 30, 37 and 60.|Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.||cells/mL||Inter-Quartile Range|Median
783305|NCT00805389|Secondary|Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils|Levels of white blood cells (WBC) as absolute counts, neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS) and basophils (BAS) were assessed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. This outcome measure presents the raw data collected in percent (%), expressed in IH Center normalized levels based on raw data in % (IH normalized %), and concerns all subjects except subjects part of the HLA Subsets 1 and 2.|At Days 0, 30, 37 and 60.|Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.||IH normalized ratio||Inter-Quartile Range|Median
783306|NCT00805389|Secondary|Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils|Levels of white blood cells (WBC) as absolute counts, neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS) and basophils (BAS) were assessed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. This outcome measure presents the raw data collected in percent (%), expressed in IH Center normalized levels based on raw data in % (IH normalized %), and concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.|At Days 0, 0+ (Day 0 + 3 to 6 hours), 1, 30, 30+ (Day 30 + 3 to 6 hours), 31, 33, 37 and 60.|Analysis was done on the According-to-Protocol (ATP) cohort for innate immunogenicity to Day 60, which included all evaluable subjects with immunogenicity and innate response (=early immune response [i.e. cytokines in serum, gene expression signature, white blood cells counts]) results available for at least one post-vaccination time point.||IH normalized ratio||Inter-Quartile Range|Median
783307|NCT00805389|Secondary|Normalized Levels of C-reactive Protein (CRP)|Analysis of levels of CRP was performed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. Levels are presented as normalized levels vs. the IH center. Normalization was performed as follows: (Raw result – lower limit normal (LLN) at the IH center) divided by (Upper Limit Normal (ULN) at the IH center minus LLN at the IH center). This outcome measure concerns all subjects except subjects part of the HLA Subsets 1 and 2.|At Days 0, 30 and 37.|Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.||IH Center normalized levels||Inter-Quartile Range|Median
783554|NCT00819039|Secondary|Number of Participants With Vomiting Frequency in Study Part 2||Up to 24 Hours|The Full Analysis Set (FAS) population was used for all efficacy evaluations and included those participants who received a full dose of active study therapy, had surgery, and had at least one post-treatment efficacy assessment.||Participants|||Number
783308|NCT00805389|Secondary|Normalized Levels of White Blood Cells (WBC) and of Creatine Phosphokinases (CPK)|Analysis of levels of CPK and WBC was performed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. Levels are presented as normalized levels vs. the IH center. Normalization was performed as follows: (Raw result – lower limit normal (LLN) at the IH center) divided by (Upper Limit Normal (ULN) at the IH center minus LLN at the IH center). This outcome measure concerns all subjects except subjects part of the HLA Subsets 1 and 2.|At Days 0, 30, 37 and 60.|Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.||IH Center normalized ratio||Inter-Quartile Range|Median
783309|NCT00805389|Secondary|Normalized Levels of C-reactive Protein (CRP)|Analysis of levels of CRP was performed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. Levels are presented as normalized levels vs. the IH center. Normalization was performed as follows: (Raw result – lower limit normal (LLN) at the IH center) divided by (Upper Limit Normal (ULN) at the IH center minus LLN at the IH center). This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.|At Days 0, 0+ (Day 0 + 3 to 6 hours), 1, 30, 30+ (Day 30 + 3 to 6 hours), 31, 33 and 37.|Analysis was done on the According-to-Protocol (ATP) cohort for innate immunogenicity to Day 60, which included all evaluable subjects with immunogenicity and innate response (=early immune response [i.e. cytokines in serum, gene expression signature, white blood cells counts]) results available for at least one post-vaccination time point.||IH Center normlized ratio||Inter-Quartile Range|Median
783310|NCT00805389|Secondary|Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK)|Analysis of levels of CPK and WBC was performed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. Levels are presented as normalized levels vs. the IH center. Normalization was performed as follows: (Raw result – lower limit normal (LLN) at the IH center) divided by (Upper Limit Normal (ULN) at the IH center minus LLN at the IH center). This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.|At Days 0, 0+ (Day 0 + 3 to 6 hours), 1, 30, 30+ (Day 30 + 3 to 6 hours), 31, 33, 37 and 60.|Analysis was done on the According-to-Protocol (ATP) cohort for innate immunogenicity to Day 60, which included all evaluable subjects with immunogenicity and innate response (=early immune response [i.e. cytokines in serum, gene expression signature, white blood cells counts]) results available for at least one post-vaccination time point.||IH Center normalized ratio||Inter-Quartile Range|Median
783311|NCT00805389|Secondary|Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum|Concentrations of IFN-g, IL-1 beta (IL-1B), IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha (TNF-a), IFN-g-inducible protein-10 (IP-10) and monocyte chemotactic protein (MCP)-1 Concentrations of the IFN-g, IL-1B, IL-5, IL-6, IL-10, TNF-a, IP-10 and MCP-1 cytokines in serum were measured by Cytokine bead assay (CBA) and expressed in picograms per milliliter (pg/mL). This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.|At Days 0, 0+ (Day 0 + 3 to 6 hours), 1, 30,30+ (Day 30 + 3 to 6 hours), 31, 33 and 37.|Analysis was done on the According-to-Protocol (ATP) cohort for innate immunogenicity to Day 60, which included all evaluable subjects with immunogenicity and innate response (=early immune response [i.e. cytokines in serum, gene expression signature, white blood cells counts]) results available for at least one post-vaccination time point.||pg/mL||Inter-Quartile Range|Median
783312|NCT00805389|Secondary|Number of Hepatitis B (HB)-Specific Memory B Cells|The number of HB-specific memory B-cells (HB mem-B cells), per million cells – expressed through tabulation of interquartile range data – was measured by B-cell Enzyme-Linked Immunosorbent Spot (ELISPOT) using Peripheral Blood Mononuclear Cells (PBMCs). This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.|At Days 180 and 360|Analysis was done on the According-to-Protocol (ATP) cohort for persistence which included all subjects from the ATP cohort for adaptive immunogenicity up to Day 60 for whom adaptive immunogenicity data were available for at least one post-vaccination time point (Day 180 or Day 360).||HB mem-B cells (per million cells)||Inter-Quartile Range|Median
783313|NCT00805389|Secondary|Number of Hepatitis B (HB)-Specific Memory B Cells|The number of HB-specific memory B-cells (HB mem-B cells), per million cells – expressed through tabulation of interquartile range data – was measured by B-cell Enzyme-Linked Immunosorbent Spot (ELISPOT) using Peripheral Blood Mononuclear Cells (PBMCs). This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.|At Days 0, 30, 37, 44 and 60.|Analysis was done on the According-to-Protocol (ATP) cohort for adaptive immunogenicity to Day 60, which included all evaluable subjects for whom T cell, antibody and memory B cell response data were available for at least one amongst the Day 0, 14, 30, 44, or 60 time points.||HB mem-B cells (per million cells)||Inter-Quartile Range|Median
783314|NCT00805389|Secondary|Anti-Hepatitis B (Anti-HB) Antibody Concentrations in Serum, as Measured by Chemi Luminescence Immuno Assay (CLIA)|Anti-HBs antibody concentrations in serum were measured by CLIA Assay. Concentrations were presented as geometric mean concentrations, in milli-International Units per milliliter (mIU/mL). Analysis was initially planned to be performed by Enzyme-Linked Immunosorbent Assay (ELISA). A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). Following these laboratory quality issues, GSB Biologicals decided to stop testing with the HBs in-house ELISA and to have the anti-HB analysis performed using the new validated CLIA assay. This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.|At Days 0, 374 and 390|Analysis was done on the Booster According-to-Protocol (ATP) cohort for immunogenicity which included all subjects from subsets 1 and 2 who received a booster vaccination at Day 360 for whom adaptive immunogenicity data were available for at least one post-booster time point.||mIU/mL||95% Confidence Interval|Geometric Mean
783342|NCT00811018|Primary|Percentage of Participants With Elevated International Normalize Ratio (INR)|Elevated INR in participants who took warfarin, warfarin derivatives, other anticoagulant and no anticoagulants. Elevated INR defined as > 3.5. Percentage calculated using number of participants with INR data as the denominator.|Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months|Safety Population||percentage of participants|||Number
783315|NCT00805389|Secondary|Anti-Hepatitis B (Anti-HB) Antibody Concentrations in Serum, as Measured by Chemi Luminescence Immuno Assay (CLIA)|Anti-HBs antibody concentrations in serum were measured by CLIA Assay. Concentrations were presented as geometric mean concentrations, in milli-International Units per milliliter (mIU/mL). Analysis was initially planned to be performed by Enzyme-Linked Immunosorbent Assay (ELISA). A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). Following these laboratory quality issues, GSB Biologicals decided to stop testing with the HBs in-house ELISA and to have the anti-HB analysis performed using the new validated CLIA assay. This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.|At Days 0, 180 and 360|Analysis was done on the According-to-Protocol (ATP) cohort for persistence which included all subjects from the ATP cohort for adaptive immunogenicity up to Day 60 for whom adaptive immunogenicity data were available for at least one post-vaccination time point (Day 180 or Day 360).||mIU/mL||95% Confidence Interval|Geometric Mean
783316|NCT00805389|Secondary|Anti-Hepatitis B (Anti-HB) Antibody Concentrations in Serum, as Measured by Chemi Luminescence Immuno Assay (CLIA)|Anti-HBs antibody concentrations in serum were measured by CLIA Assay. Concentrations were presented as geometric mean concentrations, in milli-International Units per milliliter (mIU/mL). Analysis was initially planned to be performed by Enzyme-Linked Immunosorbent Assay (ELISA). A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). Following these laboratory quality issues, GSB Biologicals decided to stop testing with the HBs in-house ELISA and to have the anti-HB analysis performed using the new validated CLIA assay. This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.|At Days 0, 30, 44, and 60|Analysis was done on the According-to-Protocol (ATP) cohort for adaptive immunogenicity to Day 60, which included all evaluable subjects for whom T cell, antibody and memory B cell response data were available for at least one amongst the Day 0, 14, 30, 44, or 60 time points.||mIU/mL||95% Confidence Interval|Geometric Mean
783317|NCT00805389|Secondary|Number of Hepatitis B (HB)-Specific Cluster of Differentiation 8 (CD8+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile|The number of HB-specific CD8+ T cells (per million cells) expressing Th1 and/or Th2 cytokine profile was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs). Since T helper cells are all CD4 T cell, no Th1/ Th2 cytokine profile was performed for CD8 T cells.|At Days 0, 14, 30, 44, 60, 180||12/2050||||
783318|NCT00805389|Secondary|Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile|The number of HB-specific CD4+ T cells (per million cells) expressing Th1 and/or Th2 cytokine profile was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs).|At Days 0 and 180|Analysis was done on the According-to-Protocol (ATP) cohort for persistence which included all subjects from the ATP cohort for adaptive immunogenicity up to Day 60 for whom adaptive immunogenicity data were available for at least one post-vaccination time point (Day 180 or Day 360).||HB-CD4+ T cells (per million cells)||Inter-Quartile Range|Median
783319|NCT00805389|Secondary|Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile|The number of HB-specific CD4+ T cells (per million cells) expressing Th1 and/or Th2 cytokine profile was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs).|At Days 0, 14, 30, 44 and 60|Analysis was done on the According-to-Protocol (ATP) cohort for adaptive immunogenicity to Day 60, which included all evaluable subjects for whom T cell, antibody and memory B cell response data were available for at least one amongst the Day 0, 14, 30, 44, or 60 time points.||HB-CD4+ T cells (per million cells)||Inter-Quartile Range|Median
783320|NCT00805389|Secondary|Number of Hepatitis B (HB)-Specific Cluster of Differentiation 8 (CD8+) T Cells|The number of HB-CD8+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD-40L), Interleukin(IL)-2, Interferon-gamma (IFN-g), and Tumor Necrosis Factor-alpha (TNF-a) was measured by Intracellular Cytokine Staining (ICS), using whole blood. This analysis was performed solely on eligible subjects enrolled at the Centre for Vaccinology (CEVAC) in Ghent, Belgium.|At Days 0, 14, 30, 44, 60 and 180|Analysis was done on the According-to-Protocol (ATP) cohort for adaptive immunogenicity to Day 60, which included all evaluable subjects for whom T cell, antibody and memory B cell response data were available for at least one amongst the Day 0, 14, 30, 44, or 60 time points.||HB-CD8+ T cells (per million cells)||Inter-Quartile Range|Median
783321|NCT00805389|Secondary|Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells|The number of HB-CD4+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD-40L), Interleukin(IL)-2, Interferon-gamma (IFN-g), and Tumor Necrosis Factor-alpha (TNF-a) was measured by Intracellular Cytokine Staining (ICS), using whole blood. This analysis was performed solely on eligible subjects enrolled at the Centre for Vaccinology (CEVAC) in Ghent, Belgium.|At Days 0, 14, 30, 33, 37, 44 and 60|Analysis was done on the According-to-Protocol (ATP) cohort for adaptive immunogenicity to Day 60, which included all evaluable subjects for whom T cell, antibody and memory B cell response data were available for at least one amongst the Day 0, 14, 30, 44, or 60 time points.||HB-CD4+ T cells (per million cells)||Inter-Quartile Range|Median
783322|NCT00805389|Secondary|Number of Hepatitis B (HB)-Specific Cluster of Differentiation 8 (CD8+) T Cells|The number of HB-CD8+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD-40L), Interleukin(IL)-2, Interferon-gamma (IFN-g), Tumor Necrosis Factor-alpha (TNF-a), IL-13 and IL-17 was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs).|At Days 0, 360 and 374|Analysis was done on the Booster According-to-Protocol (ATP) cohort for immunogenicity which included all subjects from subsets 1 and 2 who received a booster vaccination at Day 360 for whom adaptive immunogenicity data were available for at least one post-booster time point.||HB-CD8+ T cells (per million cells)||Inter-Quartile Range|Median
783343|NCT00811018|Primary|Percentage of Participants With Anticoagulant Use|Participants with anticoagulant use before first dose or participants with anticoagulant use from first dose of sitaxsentan.|Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months|Safety Population||percentage of participants|||Number
783323|NCT00805389|Secondary|Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells.|The number of HB-CD4+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD-40L), Interleukin(IL)-2, Interferon-gamma (IFN-g), Tumor Necrosis Factor-alpha (TNF-a), IL-13 and IL-17 was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs).|At Days 0, 360 and 374|Analysis was done on the Booster According-to-Protocol (ATP) cohort for immunogenicity which included all subjects from subsets 1 and 2 who received a booster vaccination at Day 360 for whom adaptive immunogenicity data were available for at least one post-booster time point.||HB-CD4+ T cells (per million cells)||Inter-Quartile Range|Median
783324|NCT00805389|Secondary|Number of Hepatitis B (HB)-Specific Cluster of Differentiation 8 (CD8+) T Cells.|The number of HB-CD8+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD-40L), Interleukin(IL)-2, Interferon-gamma (IFN-g), Tumor Necrosis Factor-alpha (TNF-a), IL-13 and IL-17 was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs).|At Days 0, 180 and 360|Analysis was done on the According-to-Protocol (ATP) cohort for persistence which included all subjects from the ATP cohort for adaptive immunogenicity up to Day 60 for whom adaptive immunogenicity data were available for at least one post-vaccination time point (Day 180 or Day 360).||HB-CD8+ T cells (per million cells)||Inter-Quartile Range|Median
783325|NCT00805389|Secondary|Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells .|The number of HB-CD4+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD-40L), Interleukin(IL)-2, Interferon-gamma (IFN-g), Tumor Necrosis Factor-alpha (TNF-a), IL-13 and IL-17 was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs).|At Days 0, 180 and 360|Analysis was done on the According-to-Protocol (ATP) cohort for persistence which included all subjects from the ATP cohort for adaptive immunogenicity up to Day 60 for whom adaptive immunogenicity data were available for at least one post-vaccination time point (Day 180 or Day 360).||HB-CD4+ T cells (per million cells)||Inter-Quartile Range|Median
783326|NCT00805389|Secondary|Number of Hepatitis B (HB)-Specific Cluster of Differentiation 8 (CD8+) T Cells.|The number of HB-CD8+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD40L), Interleukin (IL)-2, Interferon-gamma (IFN-g), Tumor Necrosis Factor-alpha (TNF-a), IL-13 and IL-17 was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs).|At Days 0, 14, 30, 44, and 60|Analysis was done on the According-to-Protocol (ATP) cohort for adaptive immunogenicity to Day 60, which included all evaluable subjects for whom T cell, antibody and memory B cell response data were available for at least one amongst the Day 0, 14, 30, 44, or 60 time points.||HB-CD8+ T cells (per million cells)||Inter-Quartile Range|Median
783327|NCT00805389|Primary|Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells .|The number of HB-CD4+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD40L), Interleukin (IL)-2, Interferon-gamma (IFN-g), Tumor Necrosis Factor-alpha (TNF-a), IL-13 and IL-17 was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs). Results for the Day 44 time point are the primary results among the outcome measure results presented.|At Days 0, 14, 30, 44 and 60|Analyses were performed on the According-to-Protocol cohort for adaptive immunogenicity up to Day 60, which included all evaluable subjects who complied with the vaccination schedule and for whom T cell, antibody and memory B cell response data were available for at least one amongst the Day 0, 14, 30, 44, or 60 time points.||HB-CD4+ T cells (per million cells)||Inter-Quartile Range|Median
783328|NCT00805467|Secondary|HAQ-DI Score|Health Assessment Questionnaire - Disability Index, a measure of physical function. The HAQ-DI score is calculated by summing the category scores from 8 sub-categories (ie, scores for patient ability in dressing and grooming, rising, eating, walking, hygeine, reach, grip and common daily activities) and dividing by the number of categories completed. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability. A HAQ-DI response is a reduction from baseline in HAQ-DI greater than or equal to the minimally important difference (0.22). BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, OR = odds ratio, PO = orally, QD = once a day.|3 years|Number of participants are those with baseline data. Baseline defined at entry into qualifying study or at entry into this study if more than 14 days since last dose in qualifying study. As no imputation was applied, the numbers at subsequent visits are lower.||Scores on a Scale||Standard Deviation|Mean
783329|NCT00805467|Secondary|DAS28-CRP Score|The Disease Activity Score 28 using C-Reactive Protein (DAS28-CRP) is a measure of disease activity in rheumatoid arthritis (RA) and assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), CRP level (a measure of inflammation in the blood), and the patient's global assessment of health (ranging from very good to very bad). These measures are then fed into a complex mathematical formula to produce the overall DAS on a scale from 1 to 10, where scores greater than 5.1 are considered to indicate active disease, scores less than 3.2 are considered to indicate with well controlled disease, and scores less than 2.6 are considered to indicate remission. bid = twice daily, CRP = C-reactive protein, DAS28 = Disease Activity Score based on a 28 joint count, n/a = not applicable, qd = once daily|3 years|Number of participants are those with baseline data. Baseline defined at entry into qualifying study or at entry into this study if more than 14 days since last dose in qualifying study. As no imputation was applied, the numbers at subsequent visits are lower.||scores on a scale||Standard Deviation|Mean
783330|NCT00805467|Primary|Percentage of Patients Who Had at Least 1 Treatment Emergent Adverse Event in Any Category|AE = adverse event, bid = twice daily, IP = investigational product, qd = once daily, SAE = serious adverse event|Entry in extension to end of study, up to a maximum of 5 years. (Variable by subject - median duration of 3 years)|The full analysis set includes those patients who received at least 1 dose of investigational product, and were summarised according to treatment first received in this study (intention-to-treat principle).||% of patients|||Number
783344|NCT00811018|Primary|Percentage of Participants With Laboratory Test Abnormalities (Urinalysis)|Urinalysis data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.|Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months|Safety Population; N=number of participants with normal observation at baseline; n=number of participants with normal baseline and an abnormality meeting specific criteria for the specific lab||percentage of participants|||Number
783331|NCT00805480|Secondary|Percentage of Participants in Each Investigator Global Assessment (IGA) Category|The IGA scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe and 5 = very severe.|Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, EOS (up to week 56)|PD analysis set participants, who had values at each week category, were included in the analysis. As such, the population at each week varies from the PD population in the participant flow. The PD analysis set included participants who had at least one dose of study medication and had no major protocol deviations.||Percentage of participants|||Number
783332|NCT00805480|Secondary|Percentage of Participants With at Least 75% or 90% Improvement From Baseline in PASI|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, EOS (up to week 56)|PD analysis set: The PD analysis set included participants who had at least one dose of study medication and had no major protocol deviations which could impact the PD analysis. At weeks 28, 36, 44 and 48, only 28 of the 29 participants in the AIN457 10mg/kg X3 group had values for analysis.||Percentage of participants|||Number
783333|NCT00805480|Secondary|Percentage of Participants With at Least 50% Improvement From Baseline in PASI|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, end of study (EOS) (up to week 56)|PD analysis set: The PD analysis set included participants who had at least one dose of study medication and had no major protocol deviations which could impact the PD analysis. At weeks 28, 36, 44 and 48, only 28 of the 29 participants in the AIN457 10mg/kg X3 group had values for analysis.||Percentage of participants|||Number
783334|NCT00805480|Primary|Percentage of Participants Who Had Not Relapsed at Any Time in the Trial|This outcome measure shows the proportion of participants in each of the AIN457 treatment groups who were relapse free throughout the study up to and including week 56.|Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 56|PD analysis set participants (AIN457 groups only), who had not yet relapsed were included in the analysis at each time point. As a result, the number of participants at risk for relapse may decrease as the number of weeks on study increases. The PD set included participants who had at least one dose of study medication and no protocol deviations.||Percentage of participants|||Number
783335|NCT00805480|Primary|Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).|Baseline, Week 12|Participants from the PD Analysis Set, who had both baseline and week 12 values, were included in the analysis. As such, the population for each treatment group is different from the PD population in the participant flow. The PD analysis set included participants who had at least one dose of study medication and had no protocol deviations.||scores on a scale||Standard Deviation|Mean
783336|NCT00805493|Primary|Pediatric Anxiety Scale|A standard measure of severity of anxiety over the previous week. The score ranges from a total of 0-25, with 0 being absence of symptoms and impairment, and 25 being marked symptoms and severe impairment. The outcome measure for each participant is the change in PARS, that is, the difference at week 8 compared to baseline (when medication-free).|Weekly for 8 weeks|||units on a scale||Standard Deviation|Mean
783337|NCT00805493|Primary|Clinical Global Impression--Improvement|This is a clinician rated measure that is a standard in pharmacological trials. the scores range from 1 to 8 with 5 being unchanged, 1 being completely recovered and 8 being markedly worse.|8 week trial with the study running for about 4 years.|||units on a scale||Standard Deviation|Mean
783338|NCT00811018|Primary|Percentage of Participants With Abnormal Partial Thromboplastin Time (PTT)|PTT data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.|Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months|Data not summarized, study terminated early||percentage of participants|||Number
783339|NCT00811018|Primary|Percentage of Participants With Abnormal Prothrombin Time (PT)|PT data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.|Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months|Data not summarized, study terminated early||percentage of participants|||Number
783340|NCT00811018|Primary|Percentage of Participants With Vital Sign Results of Potential Clinical Importance|Vital signs include sitting blood pressure, respiration rate, heart rate and temperature. Potential clinical importance determined according to investigator clinical judgement.|Day 1, Weeks 28,60,72,84,96,104, Transition visit, every 6 months Post Transition, up to 82 months|Data not summarized, study terminated early||percentage of participants|||Number
783341|NCT00811018|Primary|Percentage of Participants With Electrocardiography (ECG) Results of Potential Clinical Importance|Standard 12-lead ECG results determined to be of potential clinical importance according to investigator clinical judgement.|Weeks 28,60,72,84,96,104, Transition Visit up to 82 months|Data not summarized, study terminated early||percentage of participants|||Number
783417|NCT00817219|Primary|Adverse Drug Reactions|The number of participants experiencing each type of adverse drug reaction. Adverse drug reactions were defined as adverse events for which the investigator had not described the causal relationship to trial medication as “not related”.|Week 4|||participants|||Number
783345|NCT00811018|Primary|Percentage of Participants With Laboratory Test Abnormalities (Chemistry)|Chemistry data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.|Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months|Safety Population; N=number of participants with normal observation at baseline; n=number of participants with normal baseline and an abnormality meeting specific criteria for the specific lab||percentage of participants|||Number
783346|NCT00811018|Primary|Percentage of Participants With Laboratory Test Abnormalities (Hematology)|Hematology data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.|Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months|Safety Population; N=number of participants with normal observation at baseline; n=number of participants with normal baseline and an abnormality meeting specific criteria for the specific lab||percentage of participants|||Number
783347|NCT00811018|Primary|Percentage of Participants With Total Bilirubin > 1.5 x ULN|Total builirubin data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.|Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months|Safety Population||percentage of participants|||Number
783348|NCT00811018|Primary|The Percentage of Participants Who Experience an ALT and AST Value > 3.0 x ULN|ALT and AST data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.|Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months|Safety Population||percentage of participants|||Number
783349|NCT00811018|Primary|The Percentage of Participants Who Experience an Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) Value Greater Than (>) 3.0 Times (x) the Upper Limit of Normal Range (ULN)|ALT and AST data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.|Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months|Safety Population||percentage of participants|||Number
783350|NCT00811018|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product were reported.|Day 1 up to 82 months|Safety Population: all enrolled participants who took at least one dose of sitaxsentan 100 mg during the study||participants|||Number
783351|NCT00811057|Secondary|The Secondary Outcome Measure of This Research is the Days Gained After Treatment to Delivery|Days gained after treatment to delivery|after delivery of the infant|||days||Standard Deviation|Mean
783352|NCT00811057|Primary|The Primary Outcome Measure of This Research is to Compare the Efficacy of the Three Clinically Used Tocolytic Agents in a Prospective Study That Will Allow Direct Comparison of Outcomes in Women With Confirmed Preterm Labor.|Gestational age at delivery in weeks.|3-5 days after delivery|||weeks||Standard Deviation|Mean
783353|NCT00811070|Secondary|Overall Survival (OS) Rate - Part 2|OS was based on Kaplan-Meier method. Survival was defined as the time period from the date of first dose of bosutinib to the date of death, censored at the participant's last contact date. Percent of participants with OS were estimated.|Date of first dose of study drug up to Week 336 in primary second line participants; up to Week 192 in advanced second line and exploratory third line participants|All treated population was defined as all participants who received at least 1 dose of bosutinib.||percentage of participants||95% Confidence Interval|Number
783354|NCT00811070|Secondary|Progression-free Survival (PFS) Rate - Part 2|PFS was based on Kaplan-Meier estimates. PFS was defined as time in weeks from start of study treatment to treatment discontinuation due to disease progression as assessed by the investigator. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from death case report forms (CRFs). Percent of participants with PFS were estimated.|Date of first dose of study drug up to Week 336 in primary second line participants; up to Week 192 in advanced second line and exploratory third line participants|All treated population was defined as all participants who received at least 1 dose of bosutinib.||percentage of participants||95% Confidence Interval|Number
783355|NCT00811070|Secondary|Time to Treatment Failure (TTF) Rate - Part 2|TTF was the interval from the date of first dose of bosutinib until the earlier date of progression or death (any cause), withdrawal from treatment owing to an AE, subject refusal, or loss to follow-up (censored at the last contact date), or further anti-tumor therapy before documented progression (whichever occurred first). TTF rate indicates the probability of no treatment failure. Percent of participants with no treatment failure were estimated.|Date of first dose of study drug up to Week 336 in primary second line participants; up to Week 192 in advanced second line and exploratory third line participants|All treated population was defined as all participants who received at least 1 dose of bosutinib.||percentage of participants||95% Confidence Interval|Number
783356|NCT00811070|Secondary|Duration of Overall Hematologic Response (OHR) in Accelerated Phase/Blast Phase Third-line Cohort - Part 2|The duration of OHR was defined as the interval from the first date of response until the first date of confirmed loss of response. Duration of response in weeks =(date of confirmed loss of first attained response - date of first attained response)/7.|Baseline up to Week 192|Subset of participants who had the response among all treated population and who was in accelerated or blast phase in the third-line cohort||weeks||95% Confidence Interval|Median
783357|NCT00811070|Secondary|Time to Achieve Overall Hematologic Response (OHR) in Accelerated Phase/Blast Phase Third-line Cohort - Part 2|The time to OHR was measured from the date of first dosing to the first date of response. Time to response in weeks = (event date - first dose date plus 1)/7, where the event date is the non-missing date of the first attained response or last assessment date of a participant.|Baseline up to Week 192|Subset of participants who had the response among all treated population and who was in accelerated or blast phase in the third-line cohort||weeks||95% Confidence Interval|Median
783418|NCT00817336|Secondary|Visual P1||6 weeks|includes subjecst with valid visual p1 data||micro volts||Standard Deviation|Mean
785577|NCT00838162|Secondary|Mean Changes From Baseline in CD4+ Cell Count||Baseline (Day 1), Day 8, Day 15|Intent-to-treat (ITT) Population - all randomized participants who received at least 1 dose of study medication (TMC310911)||x 1000000 cells/L||Standard Error|Mean
783358|NCT00811070|Secondary|Percentage of Participants With Overall Hematologic Response (OHR) Up to Week 192 in Accelerated Phase/Blast Phase Third-line Cohort - Part 2|OHR included CHR, no evidence of leukemia (NEL), minor hematologic response (MiHR) or return to chronic phase (RCP), participants had to meet at least 1 of this criterion. Criteria for RCP: disappearance of features defining AP/BP, but still in CP and persistence of clonal evolution. Criteria for MiHR: <15% blasts in blood and bone marrow, <30% blasts+promyelocytes in blood and bone marrow, <20% basophils in blood, no extramedullary disease other than liver/spleen. Criteria for CHR and NEL: <20% basophils in blood, no extramedullary involvement including liver/spleen, no peripheral blasts or promyelocytes, myelocytes + metamyelocytes <5% in blood, <5% (NEL) and <=5% (CHR) marrow blasts, 0.5*10^9 <= Absolute neutrophil count (ANC) <1.0*10^9/L (NEL) and ANC>=1.0*10^9/L (CHR), 20*10^9 <=platelets<100 *10^9/L (NEL) and platelets>=100 but <450x10^9/L (CHR), white blood cells <=institutional upper limit of the normal range.|Baseline up to Week 192|Subset of the third-line cohort who was in accelerated or blast phase||percentage of participants|||Number
783359|NCT00811070|Secondary|Duration of Complete Hematologic Response (CHR) in Advanced Phase Second-line Cohort - Part 2|The duration of CHR was defined as the interval from the first date of response until the first date of confirmed loss of response. Duration of response in weeks =(date of confirmed loss of first attained response - date of first attained response)/7.|Baseline up to Week 192|Subset of participants who had the response among all treated population||weeks||95% Confidence Interval|Median
783360|NCT00811070|Secondary|Time to Achieve Complete Hematologic Response (CHR) in Advanced Phase Second-line Cohort - Part 2|The time to CHR was measured from the date of first dosing to the first date of response. Time to response in weeks = (event date - first dose date plus 1)/7, where the event date is the non-missing date of the first attained response or last assessment date of a participant.|Baseline up to Week 192|Subset of participants who had the response among all treated population.||weeks||95% Confidence Interval|Median
783361|NCT00811070|Secondary|Percentage of Participants With Complete Hematologic Response (CHR) up to Week 192 in Advance Phase Second-line Cohort - Part 2|CHR response was considered to be achieved if participants met all of the following criteria: White Blood Cells =< institutional upper limit of normal, no peripheral blood blasts or promyelocytes, myelocytes+metamyelocytes <5% in blood, absolute neutrophil count >=1.0*10^9 per liter (/L), platelets >=100 but <450*10^9/L, <20% basophils in blood and no extramedulary involvement (including hepato- or splenomegaly), =<5% BM blasts.|Baseline up to Week 192|All treated population was defined as all participants who received at least 1 dose of bosutinib.||percentage of participants||95% Confidence Interval|Number
783362|NCT00811070|Secondary|Duration of Major Cytogenetic Response (MCyR) in Chronic Phase Second-line and Third-line Cohort - Part 2|Duration of MCyR was defined as the interval from the date of the earliest demonstration of a response, until the earliest date of loss of that response. Duration of response in weeks = (date of confirmed loss of first attained response minus date of first attained response)/7 days.|204 weeks in the second-line participants and 48 weeks in the third-line participants|Subset of participants who had the response among all treated population||weeks||95% Confidence Interval|Median
783363|NCT00811070|Secondary|Time to Major Cytogenetic Response (MCyR) in Chronic Phase Second-line and Third-line Cohort - Part 2|"Time to MCyR was the interval from the date of first dose of study medication until the first date of achieving a given response.
Time to response in weeks = (event date minus first dose date plus 1)/7, where the event date is the non-missing date of the first attained response or last cytogenetic assessment date of a participants."|204 weeks in the second-line participants and 48 weeks in the third-line participants|Subset of participants who had the response among all treated population||weeks||95% Confidence Interval|Median
783364|NCT00811070|Secondary|Percentage of Participants With Major Cytogenetic Response (MCyR) at Week 24 in Chronic Phase Third-line Cohort - Part 2|Cytogenetic response (CyR) is based on the prevalence of Philadelphia positive (Ph+) cells. Major cytogenetic response was categorized as either complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). CCyR was achieved when there was 0 percent (%) Ph+ cells and PCyR was achieved when 1 to 35% Ph+ cells.|Week 24|All treated population was defined as all participants who received at least 1 dose of bosutinib.||percentage of participants||95% Confidence Interval|Number
783365|NCT00811070|Secondary|Percentage of Participants With Major Cytogenetic Response (MCyR) at Week 24 - Part 1|Cytogenetic response (CyR) is based on the prevalence of Philadelphia positive (Ph+) cells. Major cytogenetic response was categorized as either complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). CCyR was achieved when there was 0 percent (%) Ph+ cells and PCyR was achieved when 1 to 35% Ph+ cells.|Week 24|All treated population was defined as all participants who received at least 1 dose of bosutinib.||percentage of participants||95% Confidence Interval|Number
783366|NCT00811070|Secondary|Percentage of Participants With Maintained Major Cytogenetic Response (MCyR) at Week 24 in Chronic Phase Second-line and Third-line Cohort - Part 2|"Cytogenetic response (CyR) is based on the prevalence of Philadelphia positive (Ph+) cells. Major cytogenetic response was categorized as either complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). CCyR was achieved when there was 0 percent (%) Ph+ cells and PCyR was achieved when 1 to 35% Ph+ cells.
The responder for maintained MCyR included 'participants without baseline response who had a response at a specified time' and 'participants with baseline response who had a post-baseline response either maintained or improved at a specified time'."|Week 24|All treated population was defined as all participants who received at least 1 dose of bosutinib.||percentage of participants||95% Confidence Interval|Number
783367|NCT00811070|Primary|Percentage of Participants With Major Cytogenetic Response (MCyR) at Week 24 in Chronic Phase Second-line Cohort - Part 2|Cytogenetic response (CyR) is based on the prevalence of Philadelphia chromosome positive (Ph+) cells. Major cytogenetic response was categorized as either complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). CCyR was achieved when there was 0 percent (%) Ph+ cells and PCyR was achieved when 1 to 35% Ph+ cells.|Week 24|All treated population was defined as all participants who received at least 1 dose of bosutinib.||percentage of participants||95% Confidence Interval|Number
783368|NCT00811070|Secondary|Accumulation Ratio (R) - Part 1|R=accumulation ratio (AUCss on Day 15/AUC[0-24] on Day 1)|Before and 1, 2, 3, 4, 6, 8, 24 and 48 hours after administration on Day 1, and before and 1, 2, 3, 4, 6, 8, and 24 hours after administration on Day 15|The pharmacokinetic parameter population was defined as all participants who received at least 1 dose of bosutinib and had at least 1 of the pharmacokinetic parameters of interest.||ratio||Standard Deviation|Mean
783369|NCT00811070|Secondary|Apparent Volume of Distribution (Vz/F) - Part 1|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|Before and 1, 2, 3, 4, 6, 8, 24 and 48 hours after administration on Day 1|The pharmacokinetic parameter population was defined as all participants who received at least 1 dose of bosutinib and had at least 1 of the pharmacokinetic parameters of interest.||liter||Standard Deviation|Mean
783370|NCT00811070|Secondary|Apparent Oral Clearance (CL/F) - Part 1|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. CL/F on Day 15 was assessed as the steady state CL/F.|Before and 1, 2, 3, 4, 6, 8, 24 and 48 hours after administration on Day 1, and before and 1, 2, 3, 4, 6, 8, and 24 hours after administration on Day 15|"The pharmacokinetic parameter population was defined as all participants who received at least 1 dose of bosutinib and had at least 1 of the pharmacokinetic parameters of interest.
n= number of participants analyzed."||L/hr||Standard Deviation|Mean
783371|NCT00811070|Secondary|Area Under the Concentration-Time Curve (AUC) - Part 1|Area under the plasma concentration time-curve from zero to infinity. AUC on Day 15 was assessed as the steady state AUC.|Before and 1, 2, 3, 4, 6, 8, 24 and 48 hours after administration on Day 1, and before and 1, 2, 3, 4, 6, 8, and 24 hours after administration on Day 15|"The pharmacokinetic parameter population was defined as all participants who received at least 1 dose of bosutinib and had at least 1 of the pharmacokinetic parameters of interest.
n= number of participants analyzed."||nanogram*hour per milliliter (ng•hr/mL)||Standard Deviation|Mean
783372|NCT00811070|Secondary|Plasma Decay Half-Life (t1/2) - Part 1|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Before and 1, 2, 3, 4, 6, 8, 24 and 48 hours after administration on Day 1|The pharmacokinetic parameter population was defined as all participants who received at least 1 dose of bosutinib and had at least 1 of the pharmacokinetic parameters of interest.||hour||Standard Deviation|Mean
783373|NCT00811070|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) - Part 1||Before and 1, 2, 3, 4, 6, 8, 24 and 48 hours after administration on Day 1, and before and 1, 2, 3, 4, 6, 8, and 24 hours after administration on Day 15|"The pharmacokinetic parameter population was defined as all participants who received at least 1 dose of bosutinib and had at least 1 of the pharmacokinetic parameters of interest.
n= number of participants analyzed."||hour||Full Range|Median
783374|NCT00811070|Secondary|Maximum Observed Plasma Concentration (Cmax) - Part 1||Before and 1, 2, 3, 4, 6, 8, 24 and 48 hours after administration on Day 1, and before and 1, 2, 3, 4, 6, 8, and 24 hours after administration on Day 15|"The pharmacokinetic parameter population was defined as all participants who received at least 1 dose of bosutinib and had at least 1 of the pharmacokinetic parameters of interest.
n= number of participants analyzed."||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
783375|NCT00811070|Primary|Maximum Tolerated Dose (MTD) - Part 1|MTD was defined as highest dose level for which no more than 1 participant in a dose cohort experienced DLT.|Baseline up to Day 28 (Part 1 )|Participants enrolled in Part 1 of the study were analyzed for DLT. Two participants (1 each in the 400 mg and 500 mg) who discontinued the treatment by Day 28 due to non-safety reasons were excluded from the analysis.||mg|||Number
783376|NCT00811070|Primary|Number of Participants With Dose-Limiting Toxicity (DLT) - Part 1|DLT was defined as any of the following events occurring during the first 28 days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 clinically-relevant non-hematologic toxicity.|Baseline up to Day 28 (Part 1 )|Participants enrolled in Part 1 of the study were analyzed for DLT. Two participants (1 each in the 400 mg and 500 mg) who discontinued the treatment by Day 28 due to non-safety reasons were excluded from the analysis.||Participants|||Number
783377|NCT00811135|Secondary|Duration of Response (DR)|DR was defined as the time from the first recorded response (CR/PR) to the date of first documented progression or death. CR: disappearance of all target lesions and non-target lesions and normalization of tumor marker level. PR: at least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD. Progression: at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. DR was estimated using Kaplan-Meier methods.|Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)|ITT population||months||95% Confidence Interval|Median
783378|NCT00811135|Secondary|Number of Participants With Response|Participants who had CR or PR were considered as responders. CR: disappearance of all target and non-target lesions and normalization of tumor marker level; PR: at least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.|Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)|ITT population||participants|||Number
783379|NCT00811135|Secondary|Time to Progression (TTP)|TTP was defined as the time from enrollment to first documented disease progression (at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions).|Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)|ITT population||months||95% Confidence Interval|Median
783380|NCT00811135|Secondary|Number of Participants With Time to Progression (TTP)|TTP was defined as the time from enrollment to first documented disease progression (at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions). TTP was estimated using Kaplan-Meier methods.|Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)|ITT population||participants|||Number
783381|NCT00811135|Secondary|Overall Survival (OS)|OS was defined as the time from enrollment to death from any cause where enrollment was defined as successfully passed screening visit, enrolled in the study and received first dose of study treatment. OS was estimated using Kaplan-Meier methods.|Screening until death (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)|ITT population||months||95% Confidence Interval|Median
783382|NCT00811135|Secondary|Number of Participants With Overall Survival (OS)|OS was defined as the time from enrollment to death from any cause where enrollment was defined as successfully passed screening visit, enrolled in the study and received first dose of study treatment.|Screening until death (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)|ITT population||participants|||Number
783383|NCT00811135|Secondary|Progression Free Survival (PFS)|PFS was defined as the time from enrollment to time of first documented disease progression or death due to any cause, whichever occurred first. Progression: at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. PFS was estimated using Kaplan-Meier methods.|Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)|ITT population||months||95% Confidence Interval|Median
783384|NCT00811135|Secondary|Number of Participants With Disease Progression or Death|Disease progression was defined as at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)|ITT population||participants|||Number
783385|NCT00811135|Primary|Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR)|Tumor response was assessed using the Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.0. BOR was defined as the best response recorded for a participant from the start of treatment until disease progression/recurrence. Percentage of participants with a BOR of confirmed CR or PR (responders) was reported. CR: disappearance of all target and non-target lesions and normalization of tumor marker level; PR: at least a 30 percent (%) decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Confirmed responses were those which were confirmed by a repeat assessment, performed 4 weeks after the criteria for response first met.|Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)|ITT population||percentage of participants||95% Confidence Interval|Number
783386|NCT00811174|Secondary|Therapeutic Efficacy (Number of Infections, Number of Missed Days at School/ Work, Number of Hospitalisation Days, and Use of Antibiotics)||12 months|Due to premature termination of the study, data were unavailable and no analysis was done.|||||
783387|NCT00811174|Secondary|Pre-next-dose Levels of IgG Subclasses (IgG1, IgG2, IgG3, IgG4) and Pre-next-dose Levels of Specific Antibodies Against Defined Infectious Agents||before treatement 10 and 13 (of 13 or 17 treatments) and at the end|Due to premature termination of the study, data were unavailable and no analysis was done.|||||
783388|NCT00811174|Secondary|Pre-next-dose Levels of Serum Total IgG||before each treatment|Due to premature termination of the study, data were unavailable and no analysis was done.|||||
783389|NCT00811174|Secondary|Assessment of Viral Safety||Every three months|Due to premature termination of the study, data were unavailable and no analysis was done.|||||
783390|NCT00811174|Secondary|Laboratory Parameters (Hematology, Clinical Chemistry, Direct Coombs Test and Urin Analysis)||at each treatment date (every three to four weeks)|Due to premature termination of the study, data were unavailable and no analysis was done.|||||
783391|NCT00811174|Secondary|Vital Signs||during each treatment|Due to premature termination of the study, data were unavailable and no analysis was done.|||||
783392|NCT00811174|Primary|Pharmacokinetics of Serum Total IgG and IgG Subclasses (IgG1, IgG2, IgG3 and IgG4) and Pharmacokinetics of Specific Antibodies Against Defined Infectious Agents Comparing Octagam 5% Treatment With Octagam 10% Treatment|Pharmacokinetics of serum total IgG and IgG subclasses (IgG1, IgG2, IgG3 and IgG4) and pharmacokinetics of specific antibodies against defined infectious agents comparing Octagam 5% treatment with Octagam 10% treatment|after 6 months of treatment|Due to premature termination of the study, data were unavailable and no analysis was done.|||||
783393|NCT00811174|Primary|Adverse Events|Occurrence of Adverse Events|During infusion or within 72 hours after end of infusion|||participants|||Number
783394|NCT00811252|Secondary|Risk of Suicidality Using C-SSRS Scores|The Columbia-Suicide Severity Rating Scale (C-SSRS) was developed by researchers at Columbia University as a tool to systematically assess suicidal ideation and behaviour in patients during participation in a clinical study. The C-SSRS is composed of questions that address suicidal behaviour and questions that address suicidal ideation, with sub-questions that assess severity. The tool was administered via an interview with the patient.|Up to 8 weeks|C-SSRS Data by Columbia Classification Algorithm for Suicide Assessment (C-CASA) Category (APTS)||participants|||Number
783395|NCT00811252|Secondary|Proportion of Remitters at Week 8 (Remission Defined as a MADRS Total Score <=10)||Week 8|FAS; LOCF||percentage of patients|||Number
783396|NCT00811252|Secondary|Proportion of Responders at Week 8 (Response Defined as a >=50% Reduction in the HAM-D-24 Total Score)||Week 8|FAS; LOCF||percentage of patients|||Number
783397|NCT00811252|Secondary|Change From Baseline in GDS Total Score After 8 Weeks of Treatment|The Geriatric Depression Scale (GDS) is a patient self-rating scale designed for the screening of depression in the elderly. It has also been validated as a measure of depression severity. The original version consists of 30 questions with a yes/no answer. In this study, the short 15-item version was used. The total score ranges from 0 to 15, with 15 representing maximum severity.|Baseline and Week 8|FAS; observed cases (OC); ANCOVA||units on a scale||Standard Error|Mean
783398|NCT00811252|Secondary|Change in Clinical Status Using CGI-I Score at Week 8|The Clinical Global Impression - Global Improvement (CGI-I) is a 7-point scale rated from 1 (very much improved) to 7 (very much worse). The investigator rated the patient's overall improvement relative to baseline, whether or not, in the opinion of the investigator, this was entirely due to the drug treatment.|Week 8|FAS; LOCF; ANCOVA||units on a scale||Standard Error|Mean
783399|NCT00811252|Secondary|Change From Baseline in CGI-S Score After 8 Weeks of Treatment|The Clinical Global Impression - Severity of Illness (CGI-S) is a 7-point scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The investigator should use his/her total clinical experience with this patient population to judge how mentally ill the patient is at the time of rating.|Baseline and Week 8|FAS; LOCF; ANCOVA||units on a scale||Standard Error|Mean
783400|NCT00811252|Secondary|Change From Baseline in HAM-A Total Score After 8 Weeks of Treatment|The Hamilton Anxiety Rating Scale (HAM-A) consists of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behaviour at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic, and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total score from 0 to 56. The higher the score, the more severe.|Baseline and Week 8|FAS; LOCF; ANCOVA||units on a scale||Standard Error|Mean
783401|NCT00811252|Secondary|Change From Baseline in MADRS Total Score After 8 Weeks of Treatment|The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe.|Baseline and Week 8|FAS; LOCF; ANCOVA||units on a scale||Standard Error|Mean
783402|NCT00811252|Secondary|Change From Baseline in HAM-D-24 Total Score After 1 Week of Treatment||Baseline and Week 1|FAS; LOCF; ANCOVA||units on a scale||Standard Error|Mean
783403|NCT00811252|Secondary|Change From Baseline in HAM-D-24 Total Score After 2 Weeks of Treatment||Baseline and Week 2|FAS; LOCF; ANCOVA||units on a scale||Standard Error|Mean
783404|NCT00811252|Secondary|Change From Baseline in HAM-D-24 Total Score After 4 Weeks of Treatment||Baseline and Week 4|FAS; LOCF; ANCOVA||units on a scale||Standard Error|Mean
783405|NCT00811252|Secondary|Change From Baseline in HAM-D-24 Total Score After 6 Weeks of Treatment||Baseline and Week 6|FAS; LOCF, ANCOVA||units on a scale||Standard Error|Mean
783406|NCT00811252|Primary|Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment|The Hamilton Depression Scale - 24 Items (HAM-D-24) measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 76. The higher the score, the more severe.|Baseline and Week 8|Full-analysis set (FAS) – all patients in the all-patients-treated set (APTS) who had at least one valid post-baseline assessment of the primary efficacy variable; last observation carried forward (LOCF); analysis of covariance (ANCOVA)||units on a scale||Standard Error|Mean
783407|NCT00817206|Primary|Composite Endpoint for Efficacy Failure Within 12 Months of Randomization: Death, Graft Failure, Biopsy-proven Acute Rejection or Loss to Follow-up.||12 months|"One patient in each arm were randomized but not treated. Only treated patients (modified ITT population) is included in the primary outcome measure.
One patient death is listed under the Prograf arm; this patient died during follow up and did completet the study."||participants|||Number
783408|NCT00817219|Secondary|PASI 50 at Week 4.|PASI 50 is at least 50% reduction in PASI from baseline. PASI is Psoriasis Area and Severity Index and is based on the investigator'sassessment of extent and severity of the disease. It can range from 0 (best) to 64.8(worst). The PASI used in this trial is modified to exclude assessment of the head, as trial treatment is not used here.|Week 4|||participants|||Number
783409|NCT00817219|Secondary|PASI 75 at Week 4.|PASI 75 is at least 75% reduction in PASI from baseline. PASI is Psoriasis Area and Severity Index and is based on the investigator's assessment of extent and severity of the disease. It can range from 0 (best) to 64.8(worst). The PASI used in this trial is modified to exclude assessment of the head, as trial treatment is not used here.|4 weeks|||participants|||Number
783410|NCT00817219|Secondary|Percentage Change in PASI From Baseline to Week 4.|PASI is Psoriasis Area and Severity Index and is based on the investigator's assessment of extent and severity of the disease. It can range from 0 (best) to 64.8(worst). The PASI used in this trial is modified to exclude assessment of the head, as trial treatment is not used here.|Baseline and 4 weeks|||percentage||95% Confidence Interval|Mean
783411|NCT00817219|Secondary|“Controlled Disease”(i.e., “Clear” or “Very Mild”) According to the Patient’s Global Assessment of Disease Severity at Week 4.|The patient made an assessment of the disease severity using a 5-point scale (Clear, Very Mild, Mild, Moderate, and Severe).|Week 4|||participants|||Number
783412|NCT00817219|Secondary|“Controlled Disease”(i.e., “Clear” or “Almost Clear”) According to the Investigator’s Global Assessment of Disease Severity at Week 4.|The investigator made an assessment of the disease severity (Plaque thickening, Scaling and Erythema) using a 6-point scale (Clear, Almost clear, Mild, Moderate, Severe, and Very severe). This assessment represented the average lesion severity on the trunk and limbs.|Week 4|||participants|||Number
783413|NCT00817219|Primary|Change in Urinary Calcium:Creatinine Ratio From Baseline to End of Treatment.||Baseline and 4 Weeks|||mmol/g||Standard Deviation|Mean
783414|NCT00817219|Primary|Change in Albumin Corrected Serum Calcium From Baseline to End of Treatment||Baseline and 4 weeks|||mmol/L||Standard Deviation|Mean
783415|NCT00817219|Primary|Serum Cortisol Concentration of ≤18 mcg/dL at 30 and 60 Minutes After ACTH-challenge at End of Treatment|The ACTH(Adrenocorticotropic hormone)-challenge test involves injecting a synthetic subunit of ACTH into the patient,and measuring the cortisol produced by the adrenal glands 30 and 60 minutes after the injection.|Week 4|One participant did not provide data for the ACTH-challenge test following the start of treatment, thus only 32 participants were included in this analysis||participants|||Number
783416|NCT00817219|Primary|Serum Cortisol Concentration of ≤18 mcg/dL at 30 Minutes After ACTH-challenge at End of Treatment|The ACTH(Adrenocorticotropic hormone)-challenge test involves injecting a synthetic subunit of ACTH into the patient,and measuring the cortisol produced by the adrenal glands 30 and 60 minutes after the injection.|Week 4|One participant did not provide data for the ACTH-challenge test following the start of treatment, thus only 32 participants were included in this analysis||participants|||Number
783419|NCT00817336|Secondary|MATRICS|MATRICS assessing 7 domains (Speed of Processing, Attention/Vigilance, Working Memory, Verbal Learning, Visual Learning, Reasoning and Problem Solving, and Social Cognition. Raw scores are converted into a composite T-score (normative mean = 50; standard deviation = 10), where higher values indicated less impairment.|6 weeks|Final score after six weeks||T score||Standard Deviation|Mean
783420|NCT00817336|Primary|MMN Amplitude|Final MMN amplitude|6 weeks|Includes 11 subjects with analyzable MMN data||micro volts||Standard Deviation|Mean
783421|NCT00817336|Primary|PANSS Total|Positive and Negative Symptom Scale (PANSS) range 30-210|6 weeks|Final score end of six weeks||units on a scale||Standard Deviation|Mean
783422|NCT00817479|Primary|Increase in MKP1/DuSP1 mRNA Expression Level|Increase in MKP1/DuSP1 mRNA expression level is calculated as fold change = post / pre|>= 30 min|Eighteen of the 20 randomized patients received treatment. Eight of the treated patients were unevaluable because there was not enough tissue available during surgery for experimental studies; the remaining 10 patients had adequate tissue samples at baseline and at least at 30 minutes following dexamethasone/normal saline administration.||fold change||Standard Error|Mean
783423|NCT00817479|Primary|Increase in SGK1 mRNA Expression Level|Increase in SGK1 mRNA expression level is calculated as fold change = post / pre|>= 30 min|Eighteen of the 20 randomized patients received treatment. Eight of the treated patients were unevaluable because there was not enough tissue available during surgery for experimental studies; the remaining 10 patients had adequate tissue samples at baseline and at least at 30 minutes following dexamethasone/normal saline administration.||fold change||Standard Error|Mean
783424|NCT00818441|Secondary|Trough Plasma Concentrations (Ctrough) of Dacomitinib|Results for Ctrough were summarized as per the dose received during given cycle: no dose (treatment interruption at any cycle due to treatment-related toxicity), dacomitinib 15 mg (dacomitinib 15 mg at any cycle due to treatment-related toxicity at higher doses), 30 mg (dacomitinib 30 mg at any cycle as starting dose or dose reduction due to treatment-related toxicity at higher doses), 45 mg (dacomitinib 45 mg at any cycle as starting dose or dose escalation due to satisfactory toleration of dacomitinib 30 mg treatment).|Predose on C1D14, C2D1, C3D1, C4D1|Pharmacokinetic (PK) analysis set: all participants who received at least 1 dose of study medication at selected PK sites from whom at least 1 PK sample were obtained. 'N' (number of participants analyzed) = participants who were evaluable for this measure at any time point. n = participants evaluable at given time points for specified dose.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
783425|NCT00818441|Secondary|European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Score|QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, other pain, and medicine for pain ). Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results are reported for coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, and other pain. Improvement was defined as a mean decrease from baseline of ≤10. Worsened was defined as a mean increase from baseline of ≥10. Stable was a mean change from baseline of <10.|Baseline (C1D1) up to C75|PRO analysis set: participants who received >=1 dose of study medication (as-treated population), had baseline PRO assessments, >=1 on-study assessment submitted. n=participants evaluable at specified time points for given parameter.||number of participants|||Number
783426|NCT00818441|Secondary|European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status (GHS), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulties). Most questions used 4- point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). For GHS, functional scales, symptom scales and single items, scores were averaged, transformed to 0-100 scale; higher score=better level of functioning/health or greater degree of symptoms. Improvement was defined as a mean increase from baseline of ≥10 for GHS and functional scales or a mean decrease from baseline of ≤10 for symptom scales. Worsened was defined as a mean decrease from baseline of ≤10 for GHS and functional scales or a mean increase from baseline of ≥10 for symptom scales. Stable was a mean change from baseline of <10.|Baseline (Cycle [C]1 Day 1), up to C75|Patient reported Outcome (PRO) analysis set:participants who received at least (>=) 1 dose of study medication (as-treated population), had baseline PRO assessments, >=1 on-study assessment submitted. 'N' (number of participants analyzed)=participants evaluable for this measure.n=participants evaluable at specified time points for given parameter.||number of participants|||Number
783427|NCT00818441|Secondary|Overall Survival (OS)|Time in months from the start of study treatment to date of death due to any cause. OS was calculated as (the death date or last alive date minus the date of first dose of study medication plus 1) divided by 30.44. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Randomization until death or last date known to be alive.|As-enrolled population included all participants who were enrolled in the study.||months||95% Confidence Interval|Median
783428|NCT00818441|Secondary|Duration of Response (DR)|Time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause, whichever occurs first. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to any cause [if not reached, censored date] minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.44. DR was calculated for a subgroup of participants with a confirmed objective tumor response.|Baseline until progression or initiation of new anti-cancer therapy or death, assessed at baseline, at the end of Cycle 1, Cycle 2, and then every other cycle.|DR was calculated for a subgroup of participants from the response-evaluable population, who had confirmed objective tumor response (CR or PR).||months||95% Confidence Interval|Median
783462|NCT00818623|Secondary|Number of Participants With Testosterone Level ≤0.5 ng/mL for at Least 28 Days|The table shows the number of participants with testosterone level ≤0.5 ng/mL for at least 28 days.|Two - six months|ITT population.||participants|||Number
783429|NCT00818441|Secondary|Best Overall Response (BOR)|BOR: best response recorded from treatment start until disease progression/recurrence based on RECIST v1.0. Complete Response (CR): disappearance of all lesions. Partial Response (PR): >=30% decrease in sum of longest diameters of target lesions taking as reference baseline sum of longest diameters, associated to non-progressive disease response for non target lesions. PD: >=20% increase in sum of longest diameters of target lesions taking as reference smallest sum of longest diameters since treatment start, or appearance of >=1 new lesion, or unequivocal progression in non-target lesions. Stable disease (SD): neither shrinkage for CR/PR nor increase for PD taking as reference smallest sum of longest diameters since treatment start. CR and PR had to be confirmed on a follow up imaging assessment >=4 weeks after the initial objective documentation of the response. SD must have met the SD criteria at least once after start of treatment in a minimum interval of 6 weeks.|Baseline until progression or initiation of new anti-cancer therapy or death, assessed at baseline, at the end of Cycle 1, Cycle 2, and then every other cycle.|Response-evaluable population included all enrolled participants who received at least 1 dose of study medication, had an adequate baseline tumor assessment, and had at least 1 on-study tumor assessment after the first dosing.||participants|||Number
783430|NCT00818441|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time in months from the first dosing date to the date of first documentation of progression or death due to any cause, whichever occurs first. PFS was calculated as (first event date [if not reached, censored date as the last known event-free date] minus first dosing date plus 1) divided by 30.44. PD: >= 20% increase in the sum of the longest dimensions of the target lesions taking as a reference the smallest sum of the longest dimensions recorded since the start of treatment, or the appearance of 1 or more new lesions. Documentation of progression was determined from objective disease assessment based on RECIST v1.0 criteria.|Baseline until progression or initiation of new anti-cancer therapy or death, assessed at baseline, at the end of Cycle 1, Cycle 2, and then every other cycle.|As-enrolled population included all participants who were enrolled in the study.||months||95% Confidence Interval|Median
783431|NCT00818441|Secondary|Progression-Free Survival (PFS) at Month 4: Cohort B|PFS at Month 4 was defined as percentage of patients who were alive and event free (event defined as PD or death due to any cause, whichever occurs first) at 4 months after the first dose of study treatment. Documentation of progression was based on RECIST v1.0 criteria. PD: >=20% increase in the sum of the longest dimensions of the target lesions taking as a reference the smallest sum of the longest dimensions recorded since the start of treatment, or the appearance of 1 or more new lesions, or unequivocal progression in non-target lesions.|Baseline up to Month 4|||percent chance of being event-free||95% Confidence Interval|Number
783432|NCT00818441|Primary|Progression-Free Survival (PFS) at Month 4: Cohort A|PFS at Month 4 was defined as percentage of participants who were alive and event free (event defined as progressive disease [PD] or death due to any cause, whichever occurs first) at 4 months after the first dose of study treatment. Documentation of progression was based on Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0) criteria. PD = greater than or equal to (>=) 20 percent (%) increase in the sum of the longest dimensions of the target lesions taking as a reference the smallest sum of the longest dimensions recorded since the start of treatment, or the appearance of 1 or more new lesions, or unequivocal progression in non-target lesions.|Baseline up to Month 4|As-enrolled population included all participants who were enrolled in the study.||percentage of participants||95% Confidence Interval|Number
783433|NCT00818454|Secondary|Peak FEV1 Response|Change from baseline after 4 weeks in peak Forced Expiratory Volume response|Test day baseline and test day peak FEV1, after 4 weeks|These analyses were done on FAS2. FAS2 is all patients who were dispensed study medication, were documented to have taken at least one dose of investigational treatment, and had a non-missing Visit 7 baseline value and non-missing responses for both peak FEV1 and FEV1 AUC0-6 at Visit 7.||liters||Standard Error|Least Squares Mean
783434|NCT00818454|Secondary|FEV1 AUC0-6 Response (Parallel Part of the Study)|Change from baseline after 4 weeks in Forced Expiratory Volume Area Under the Curve from 0 to 6 hours|Test day baseline and test day FEV1 AUC 0-6, after 4 weeks|These analyses were done on FAS2. FAS2 is all patients who were dispensed study medication, were documented to have taken at least one dose of investigational treatment, and had a non-missing Visit 7 baseline value and non-missing responses for both peak FEV1 and FEV1 AUC0-6 at Visit 7.||liters||Standard Error|Least Squares Mean
783435|NCT00818454|Secondary|Puffs Open-label Albuterol Used During Night (Crossover Part of the Study)|Change from baseline in weekly mean of puffs of open-label albuterol used during night|Baseline, 4 weeks|Full analysis set 1 (FAS1) consisted of all patients who were dispensed study medication, were documented to have taken at least one dose of investigational treatment, and had non-missing Visit 3 baseline values and non-missing responses for both peak FEV1 and FEV1 AUC0-6 at Visit 3.||Puffs||Standard Error|Least Squares Mean
783436|NCT00818454|Secondary|Puffs Open-label Albuterol Used During Day (Crossover Part of the Study)|Change from baseline in weekly mean of puffs of open-label albuterol used during day|Baseline, 4 weeks|Full analysis set 1 (FAS1) consisted of all patients who were dispensed study medication, were documented to have taken at least one dose of investigational treatment, and had non-missing Visit 3 baseline values and non-missing responses for both peak FEV1 and FEV1 AUC0-6 at Visit 3.||Puffs||Standard Error|Least Squares Mean
783437|NCT00818454|Secondary|Puffs Study Medication Used During Night (Crossover Part of the Study)|Change from baseline in weekly mean of puffs of blinded study medication (albuterol HFA or combivent CFC) used during night|Baseline, 4 weeks|Full analysis set 1 (FAS1) consisted of all patients who were dispensed study medication, were documented to have taken at least one dose of investigational treatment, and had non-missing Visit 3 baseline values and non-missing responses for both peak FEV1 and FEV1 AUC0-6 at Visit 3.||Puffs||Standard Error|Least Squares Mean
783438|NCT00818454|Secondary|Puffs Study Medication Used During Day (Crossover Part of the Study)|Change from baseline in weekly mean of puffs of blinded study medication (albuterol HFA or combivent CFC) used during day|Baseline, 4 weeks|Full analysis set 1 (FAS1) consisted of all patients who were dispensed study medication, were documented to have taken at least one dose of investigational treatment, and had non-missing Visit 3 baseline values and non-missing responses for both peak FEV1 and FEV1 AUC0-6 at Visit 3.||Puffs||Standard Error|Least Squares Mean
783463|NCT00818623|Primary|Time From Dosing Until Testosterone Levels >0.5 ng/mL|Intent-to-treat (ITT) population. This outcome measure is based on one testosterone value >0.5 ng/mL at Day 28 onwards.|3 months|ITT population.||days||95% Confidence Interval|Median
783439|NCT00818454|Secondary|Asthma Control Questionnaire (Crossover Part of the Study)|Change from baseline after 4 weeks in ACQ score. Worst score - 6(most severe), best score - 0 (no symptoms)|Baseline, 4 weeks|Full analysis set 1 (FAS1) consisted of all patients who were dispensed study medication, were documented to have taken at least one dose of investigational treatment, and had non-missing Visit 3 baseline values and non-missing responses for both peak FEV1 and FEV1 AUC0-6 at Visit 3.||Scores on scale||Standard Error|Least Squares Mean
783440|NCT00818454|Secondary|Mini Asthma Quality of Life Questionnaire (Crossover Part of the Study)|Change from baseline after 4 weeks in Mini-AQLQ score. Worst score - 1 (most severe), best score - 7 (less severe)|Baseline, 4 weeks|Full analysis set 1 (FAS1) consisted of all patients who were dispensed study medication, were documented to have taken at least one dose of investigational treatment, and had non-missing Visit 3 baseline values and non-missing responses for both peak FEV1 and FEV1 AUC0-6 at Visit 3.||Scores on scale||Standard Error|Least Squares Mean
783441|NCT00818454|Primary|Peak FEV1 Response (Crossover Part of the Study)|Change from baseline after 4 weeks in peak Forced Expiratory Volume response|Test day baseline and test day peak FEV1, after 4 weeks|Full analysis set 1 (FAS1) consisted of all patients who were dispensed study medication, were documented to have taken at least one dose of investigational treatment, and had non-missing Visit 3 baseline values and non-missing responses for both peak FEV1 and FEV1 AUC0-6 at Visit 3.||liters||Standard Error|Least Squares Mean
783442|NCT00818454|Primary|FEV1 AUC0-6 Response (Crossover Part of the Study)|Change from baseline after 4 weeks in Forced Expiratory Volume Area Under (FEV1 AUC) the Curve from 0 to 6 hours.|Test day baseline and test day FEV1 AUC 0-6, after 4 weeks|Full analysis set 1 (FAS1) consisted of all patients who were dispensed study medication, were documented to have taken at least one dose of investigational treatment, and had non-missing Visit 3 baseline values and non-missing responses for both peak FEV1 and FEV1 AUC0-6 at Visit 3.||liters||Standard Error|Least Squares Mean
783443|NCT00818519|Secondary|Percentage of Participants Classified as “Improved” According to the Investigator’s Overall Improvement Rating and on the Participant’s Overall Self-Assessment Rating|"The proportion of participants rated as “improved” comprises those with complete remission, excellent, marked, or moderate improvement according to the Investigator’s Overall Improvement Rating and those with excellent, good, or fair improvement the Participant’s Overall Self-Assessment Rating. No improvement or deterioration (worsening of disease signs and symptoms compared to Baseline in the view of investigator/subject) comprise not improved status."|At Cycle 6 (Day 15±3 days of Treatment Cycle 6, 28 days per cycle)|FAS (due to missing data number of participants differs from number at Baseline)||Percentage of participants|||Number
783444|NCT00818519|Secondary|Percent Change From Cycle 6 to Baseline in Lesion Count of Closed Comedones|Acne lesions were counted by the trained designee over the entire face. All closed comedones were to be identified and separately counted. The percent change from Cycle 6 to Baseline was calculated as (closed comedone count at Baseline - closed comedone count at Cycle 6)/(closed comedone count at Baseline)*100, so that improvement is indicated by a larger percent change.|Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline|FAS (due to missing data number of participants differs from number at Baseline)||Percent change||Standard Deviation|Mean
783445|NCT00818519|Secondary|Percent Change From Cycle 6 to Baseline in Lesion Count of Open Comedones|Acne lesions were counted by the trained designee over the entire face. All open comedones were to be identified and separately counted. The percent change from Cycle 6 to Baseline was calculated as (open comedone count at Baseline -open comedone count at Cycle 6)/(open comedone count at Baseline)*100, so that improvement is indicated by a larger percent change.|Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline|FAS (due to missing data number of participants differs from number at Baseline)||Percent change||Standard Deviation|Mean
783446|NCT00818519|Secondary|Percent Change From Cycle 6 to Baseline in Lesion Count of Nodules|Acne lesions were counted by the trained designee over the entire face. All nodules were to be identified and separately counted. The percent change from Cycle 6 to Baseline was calculated as (nodule count at Baseline - nodule count at Cycle 6)/(nodule count at Baseline)*100, so that improvement is indicated by a larger percent change.|Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline|FAS (due to missing data number of participants differs from number at Baseline)||Percent change||Standard Deviation|Mean
783447|NCT00818519|Secondary|Percent Change From Cycle 6 to Baseline in Lesion Count of Pustules|Acne lesions were counted by the trained designee over the entire face. All pustules were to be identified and separately counted. The percent change from Cycle 6 to Baseline was calculated as (pustule count at Baseline - pustule count at Cycle 6)/(pustule count at Baseline)*100, so that improvement is indicated by a larger percent change.|Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline|FAS (due to missing data number of participants differs from number at Baseline)||Percent change||Standard Deviation|Mean
783448|NCT00818519|Secondary|Percent Change From Cycle 6 to Baseline in Lesion Count of Papules|Acne lesions were counted by the trained designee over the entire face. All papules were to be identified and separately counted. The percent change from Cycle 6 to Baseline was calculated as (papule count at Baseline - papule count at Cycle 6)/(papule count at Baseline)*100, so that improvement is indicated by a larger percent change.|Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline|FAS (due to missing data number of participants differs from number at Baseline)||Percent change||Standard Deviation|Mean
783449|NCT00818519|Secondary|Percent Change From Cycle 6 to Baseline in Inflammatory Lesion Count (Papules, Pustules, and Nodules), Non-inflammatory Lesion Count|Acne lesions were counted by the trained designee over the entire face. All types of lesions were to be identified and separately counted, i.e., non-inflammatory open and closed comedones, and inflammatory papules, pustules, and nodules. The percent change from Cycle 6 to Baseline was calculated as (lesion count at Baseline - lesion count at Cycle 6)/(lesion count at Baseline)*100, so that improvement is indicated by a larger percent change.|Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline|FAS (due to missing data number of participants differs from number at Baseline)||Percent change||Standard Deviation|Mean
783464|NCT00818649|Secondary|Correlation of Cell Alterations With Clinical Response|Analysis of Natural Killer (NK) Cell Activating and Inhibitory Receptor Alterations, NK Cell Receptor Ligand Alterations, HLA Class I Expression on Target Cells (Myeloid Blasts), and NK-mediated Cell Killing|Pre-Study and After 3 Cycles|Natural Killer cell studies were discontinued after the first 3 patients because the results were not helpful. So, secondary outcome measures were not completed.|||||
783450|NCT00818519|Secondary|Percentage of Participants Classified as “0” or “1” on the 6-point ISGA (Investigator Static Global Assessment) Scale at Cycle 6|ISGA scale 0: Normal, clear skin with no evidence of acne vulgaris; 1: Skin is almost clear: few non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving, not pink-red), no nodular lesions; 2: Few inflammatory lesions, little inflammation, some comedones, no nodular lesions; 3: Non-inflammatory lesions predominate, several inflammatory lesions, one small nodular lesion maybe present; 4: Many inflammatory lesions, up to many comedones, up to a few nodular lesions; 5: Numerous highly inflammatory lesions predominate, many papules and pustules or nodular lesions|Cycle 6 (Day 15±3 days of Treatment Cycle 6)|FAS, all participants with data for Cycle 6||Percentage of participants|||Number
783451|NCT00818519|Secondary|Percentage of Participants Classified as “0” or “1” on the 6-point ISGA (Investigator Static Global Assessment) Scale at Cycle 3|ISGA scale 0: Normal, clear skin with no evidence of acne vulgaris; 1: Skin is almost clear: few non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving, not pink-red), no nodular lesions; 2: Few inflammatory lesions, little inflammation, some comedones, no nodular lesions; 3: Non-inflammatory lesions predominate, several inflammatory lesions, one small nodular lesion maybe present; 4: Many inflammatory lesions, up to many comedones, up to a few nodular lesions; 5: Numerous highly inflammatory lesions predominate, many papules and pustules or nodular lesions|Cycle 3 (Day 15±3 days of Treatment Cycle 3)|FAS, all participants with data for Cycle 3||Percentage of participants|||Number
783452|NCT00818519|Secondary|Percentage of Participants Classified as “0” or “1” on the 6-point ISGA (Investigator Static Global Assessment) Scale at Cycle 1|ISGA scale 0: Normal, clear skin with no evidence of acne vulgaris; 1: Skin is almost clear: few non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving, not pink-red), no nodular lesions; 2: Few inflammatory lesions, little inflammation, some comedones, no nodular lesions; 3: Non-inflammatory lesions predominate, several inflammatory lesions, one small nodular lesion maybe present; 4: Many inflammatory lesions, up to many comedones, up to a few nodular lesions; 5: Numerous highly inflammatory lesions predominate, many papules and pustules or nodular lesions|Cycle 1 (Day 15±3 days of Treatment Cycle 1)|FAS, all participants with data for Cycle 1||Percentage of participants|||Number
783453|NCT00818519|Secondary|Percentage of Participants Classified as “0” or “1” on the 6-point ISGA (Investigator Static Global Assessment) Scale at Screening Visit|ISGA scale 0: Normal, clear skin with no evidence of acne vulgaris; 1: Skin is almost clear: few non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving, not pink-red), no nodular lesions; 2: Few inflammatory lesions, little inflammation, some comedones, no nodular lesions; 3: Non-inflammatory lesions predominate, several inflammatory lesions, one small nodular lesion maybe present; 4: Many inflammatory lesions, up to many comedones, up to a few nodular lesions; 5: Numerous highly inflammatory lesions predominate, many papules and pustules or nodular lesions|Screening visit|Full analysis set at screening||Percentage of participants|||Number
783454|NCT00818519|Primary|Percent Change From Cycle 6 to Baseline in the Total Lesion Count (Open and Closed Comedones, Papules, Pustules, and Nodules) in the PPS (Per Protocol Set)|Acne lesions were counted by the trained designee over the entire face. All types of lesions were to be identified and separately counted, i.e., non-inflammatory open and closed comedones, and inflammatory papules, pustules, and nodules. The percent change from Cycle 6 to Baseline was calculated as (total lesion count at Baseline - total lesion count at Cycle 6)/(total lesion count at Baseline)*100, so that improvement is indicated by a larger percent change.|Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline|PPS||Percent change||Standard Deviation|Mean
783455|NCT00818519|Primary|Percent Change From Cycle 6 to Baseline in the Total Lesion Count (Open and Closed Comedones, Papules, Pustules, and Nodules) in the FAS (Full Analysis Set)|Acne lesions were counted by the trained designee over the entire face. All types of lesions were to be identified and separately counted, i.e., non-inflammatory open and closed comedones, and inflammatory papules, pustules, and nodules. The percent change from Cycle 6 to Baseline was calculated as (total lesion count at Baseline - total lesion count at Cycle 6)/(total lesion count at Baseline)*100, so that improvement is indicated by a larger percent change.|Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline|FAS||Percent change||Standard Deviation|Mean
783456|NCT00818623|Secondary|Participants With Markedly Abnormal Change in Vital Signs and Body Weight|Vital signs and body weight included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of participants in each group with normal baseline and markedly abnormal value post-baseline.|3 months|ITT population. The first value in the category represents the actual clinical reading and the second is the change from baseline for blood pressure (units: millimeters of mercury) and heart rate (units:beats per minute). The weight category includes participants whose percent weight change from baseline fit the stated ranges.||participants|||Number
783457|NCT00818623|Secondary|Evaluation of Liver Function Tests|The figures presents the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases >3x ULN and ALT increases >3x ULN with concurrently increased bilirubin >1.5 ULN.|3 months|||participants|||Number
783458|NCT00818623|Secondary|Time to 90% Reduction in Prostate-specific Antigen Levels|The time to 90% prostate-specific antigen (PSA) reduction from baseline was defined as the number of days from dosing to the first visit where a 90% reduction in PSA level was reached.|3 months|ITT population. Participants who did not achieve the actual level of reduction were censored as of the time from dosing for the last available observation.||days||Full Range|Median
783459|NCT00818623|Secondary|Time to 50% Reduction in Prostate-specific Antigen Levels|The time to 50% prostate-specific antigen (PSA) reduction from baseline was defined as the number of days from dosing to the first visit where a 50% reduction in PSA level was reached.|3 months|ITT population. Patients who did not achieve the actual level of reduction were censored as of the time from dosing for the last available observation.||days||Full Range|Median
783460|NCT00818623|Secondary|Time to Testosterone Castration (Testosterone ≤0.5 ng/mL)|Time to testosterone castration was calculated as the number of days from dosing to the first scheduled visit when testosterone was less than 0.5 ng/mL.|3 months|ITT population||days||Full Range|Median
783461|NCT00818623|Secondary|Number of Participants With Testosterone Level ≤0.5 ng/mL for at Least 84 Days|The table shows the number of participants with testosterone level ≤0.5 ng/mL for at least 84 days.|3 months|ITT population.||participants|||Number
783465|NCT00818649|Secondary|Correlative Laboratory Studies|Analysis of Natural Killer (NK) Cell Activating and Inhibitory Receptor Alterations, NK Cell Receptor Ligand Alterations, HLA Class I Expression on Target Cells (Myeloid Blasts), and NK-mediated Cell Killing|Pre-Study and After 3 Cycles|Natural Killer cell studies were discontinued after the first 3 patients because the results were not helpful, and thus the secondary outcome measures were not completed.|||||
783466|NCT00818649|Primary|Number of Patients by Best Clinical Response|Assessed by the International Working Group response criteria: Complete Remission - <5% myeloblasts with normal maturation of all cell lines; Partial Remission - bone marrow blasts decreased by > 50% over pre-treatment but still >5%; and Hematologic Improvement - hemoglobin increase by > 1.5g/dl or decreased transfusions by at least 4/8 week period, platelet absolute increase of >30 X 10^9/L for those starting at >20 X 10^9/L . For those < 20 X 10^9 /L at baseline increase by 100%.|At Completion of Course 3 (Day 63)|Evaluable patients are defined as those who completed at least 1 cycle of therapy; 8 had acute myeloid leukemia, 4 had myelodysplastic syndrome.||Patients|||Number
783467|NCT00818662|Secondary|Number of Participants Experiencing a Clinically Significant Rash|Participants requiring systemic therapy or discontinuation from further treatment|Throughout the study period, approximately 4 years|Safety Analysis Set||participants|||Number
783468|NCT00818662|Secondary|Number of Participants Experiencing a Clinically Significant Decrease in Hemoglobin (>1.5 g/dL) Between Consecutive Visits||Throughout the study period, approximately 4 years|Safety Analysis Set||participants|||Number
783469|NCT00818662|Secondary|Number of Infusions Discontinued, Slowed, or Interrupted Due to an Adverse Event (AE)||Throughout each infusion period|Safety Analysis Set||Adverse events|Participants||Number
783470|NCT00818662|Secondary|Number of Infusions With Causally Associated Non-serious Adverse Events (Non-SAEs) and/or Serious Adverse Events (SAEs)|Each adverse event (AE) that was considered related to investigational product (IP) was linked to the most recent infusion administered|Throughout the study period, approximately 4 years|Safety Analysis Set||Infusions|Participants||Number
783471|NCT00818662|Secondary|Number of Infusions Temporally Associated With Non-serious Adverse Events (Non-SAEs) and/or Serious Adverse Events (SAEs)|Refers to non-SAEs and/or SAEs occurring during infusion or within 72 hours of completion of infusion (regardless of causality)|During or within 72 hours of completion of an infusion|Safety Analysis Set||Infusions|Participants||Number
783472|NCT00818662|Secondary|Number of Participants Experiencing Any Serious Adverse Events (SAEs), by System Organ Class|Related and unrelated SAEs|Throughout the study period, approximately 4 years|Safety Analysis Set||participants|||Number
783473|NCT00818662|Secondary|Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class|Related and unrelated non-SAEs|Throughout the study period, approximately 4 years|Safety Analysis Set||participants|||Number
783474|NCT00818662|Secondary|Number of Participants Experiencing Study Product-related Serious Adverse Events (SAEs), by System Organ Class||Throughout the study period, approximately 4 years|Safety Analysis Set||participants|||Number
783475|NCT00818662|Secondary|Number of Participants Experiencing Study Product-related Non-serious Adverse Events (Non-SAEs), by System Organ Class||Throughout the study period, approximately 4 years|Safety Analysis Set||participants|||Number
783476|NCT00818662|Secondary|Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Clock Drawing Test|In this test, which assesses constructional ability, visuoperception, and executive functioning, the participant is given a blank sheet of paper and asked to draw the face of a clock showing the numbers and 2 hands set to ‘ten after eleven.’ Results are presented as score obtained (range 0 to 5, with 0 indicating the greatest impairment).|Baseline & 18 months|Per-Protocol Analysis Set with both baseline and month 18 assessments.||Scores on a scale||Standard Deviation|Mean
783477|NCT00818662|Secondary|Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Trail-Making Test (TMT), Part B|This test, which has 2 parts, is used to assess processing speed, visuomotor and perceptual scanning skills, and executive function. In Part A, 25 circles each containing a number between 1 and 25 are randomly placed on a sheet of paper, and the participant is asked to draw a line as quickly as possible between each circle in ascending numerical order. In Part B, 25 circles are again randomly placed on a sheet of paper; however, in this test 13 of the circles contain the numbers 1 through 13, and the remaining 12 circles contain the letters A through L. In this test, the participant must draw a line as quickly as possible between the circles in alternating between numbers and letters in ascending order (e.g., 1 to A, A to 2, 2 to B,…). Total values for TMT Part B range between 0 and 300 seconds. Results are presented as time to complete; therefore, higher numbers indicate greater impairment.|Baseline & 18 months|Per-Protocol Analysis Set with both baseline and month 18 assessments.||seconds||Standard Deviation|Mean
783478|NCT00818662|Secondary|Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Trail-Making Test (TMT), Part A|This test, which has 2 parts, is used to assess processing speed, visuomotor and perceptual scanning skills, and executive function. In Part A, 25 circles each containing a number between 1 and 25 are randomly placed on a sheet of paper, and the participant is asked to draw a line as quickly as possible between each circle in ascending numerical order. In Part B, 25 circles are again randomly placed on a sheet of paper; however, in this test 13 of the circles contain the numbers 1 through 13, and the remaining 12 circles contain the letters A through L. In this test, the participant must draw a line as quickly as possible between the circles in alternating between numbers and letters in ascending order (e.g., 1 to A, A to 2, 2 to B,…). Total values for TMT Part A range between 0 and 150 seconds. Results are presented as time to complete; therefore, higher numbers indicate greater impairment.|Baseline & 18 months|Per-Protocol Analysis Set with both baseline and month 18 assessments.||seconds||Standard Deviation|Mean
783479|NCT00818662|Secondary|Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Animals Category Fluency|In this test, which assesses semantic verbal fluency, participants are given 1 minute to name as many items in the category “animals” as possible. To receive credit that word cannot be a mythical animal, but can be an animal species; breed; male, female, or infant name for a species (e.g., bull, cow, calf); in addition, names for birds, fish, reptiles, and insects receive credit. Results are presented as total number correct; therefore, lower numbers indicate greater impairment.|Baseline & 18 months|Per-Protocol Analysis Set with both baseline and month 18 assessments.||correct responses||Standard Deviation|Mean
783480|NCT00818662|Secondary|Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Wechsler Adult Intelligence Scale- Revised (WAIS-R) Digit Symbol Substitution|WAIS–R digit symbol substitution test assesses attention, psychomotor speed, complex scanning, visual tracking, and immediate memory. This test consists of 4 rows each with 25 small blank squares; above each square is a number between 1 and 9. At the top is a ‘key,’ which pairs each number (1 through 9) with an unfamiliar symbol. The participant has 90 seconds to work as quickly as possible (left to right across the rows) to fill in each blank square with the appropriate symbol based on the number above the square. Results are presented as total number correct; therefore, lower numbers indicate greater impairment.|Baseline & 18 months|Per-Protocol Analysis Set with both baseline and month 18 assessments.||correct responses||Standard Deviation|Mean
783481|NCT00818662|Secondary|Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: FAS Verbal Fluency|In the FAS assessment of phenomic verbal fluency, participants are given 1 minute each to name as many words as they can that begin with a specified letter (F, A, S). To receive credit, words must be verifiable in a dictionary, cannot be proper nouns, and cannot be the same word or variations of the same word (e.g., the same word with a different ending, such as ‘acts,’ ‘acted,’ ‘acting’). Results are presented as total number correct; therefore, lower numbers indicate greater impairment.|Baseline & 18 months|Per-Protocol Analysis Set with both baseline and month 18 assessments.||correct responses||Standard Deviation|Mean
783482|NCT00818662|Secondary|Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Wechsler Adult Intelligence Scale- Revised (WAIS-R) Digit Span Backward|This test assesses working memory and attention, the rater asks the participant to repeat single-digit number sequences of increasing length, which are read aloud by the rater (in forward or backward order). Two trials are presented for each sequence length, and the test is ended when the participant misses both trials at a given sequence length. The WAIS-R score ranged from 0-14. Results are presented as total number correct; therefore, lower numbers represent greater impairment.|Baseline & 18 months|Per-Protocol Analysis Set with both baseline and month 18 assessments.||correct responses||Standard Deviation|Mean
783483|NCT00818662|Secondary|Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Wechsler Adult Intelligence Scale- Revised (WAIS-R) Digit Span Forward|This test assesses working memory and attention, the rater asks the participant to repeat single-digit number sequences of increasing length, which are read aloud by the rater (in forward or backward order). Two trials are presented for each sequence length, and the test is ended when the participant misses both trials at a given sequence length. The WAIS-R score ranged from 0-14. Results are presented as total number correct; therefore, lower numbers represent greater impairment.|Baseline & 18 months|Per-Protocol Analysis Set with both baseline and month 18 assessments.||correct responses||Standard Deviation|Mean
783484|NCT00818662|Secondary|Change From Baseline at 18 Months in the Logsdon Quality of Life in Alzheimer's Disease (QOL-AD) Assessment- Caregiver Response|The QOL AD is a validated, 13-item instrument developed specifically for individuals with dementia. The assessment rates the participant's quality of life for physical, emotional, interpersonal, and environmental domains. The QOL-AD total score ranged 13-52. Lower scores on the QOL AD are associated with a lower quality of life.|Baseline & 18 months|Intent-to-Treat Analysis Set with both baseline and month 18 assessments.||Scores on a scale||Standard Deviation|Mean
783485|NCT00818662|Secondary|Change From Baseline at 18 Months in the Logsdon Quality of Life in Alzheimer's Disease (QOL-AD) Assessment- Participant Response|The QOL AD is a validated, 13-item instrument developed specifically for individuals with dementia. The assessment rates the participant’s quality of life for physical, emotional, interpersonal, and environmental domains. The QOL-AD total score ranged 13-52. Lower scores on the QOL AD are associated with a lower quality of life.|Baseline & 18 months|Intent-to-Treat Analysis Set with both baseline and month 18 assessments.||Scores on a scale||Standard Deviation|Mean
783486|NCT00818662|Secondary|Change From Baseline at 18 Months in the Neuropsychiatric Inventory (NPI) Assessment|The NPI is a validated instrument used to assess behavioral psychopathology in AD; it evaluates the frequency and severity of 12 neuropsychiatric features including delusions, hallucinations, dysphoria, anxiety, agitation/aggression, euphoria, disinhibition, irritability/lability, apathy, aberrant motor activity, sleep and night-time behavior change, and appetite and eating change. The NPI total score ranged 0-144, with higher scores indicating greater impairment.|Baseline & 18 months|Intent-to-Treat Analysis Set with both baseline and month 18 assessments.||Scores on a scale||Standard Deviation|Mean
783487|NCT00818662|Secondary|Change From Baseline at 18 Months in the Modified Mini-Mental State Examination (3MS) Examination|The 3MS is a comprehensive validated instrument that provides a 100 point composite rating for spatial and temporal orientation, verbal recall, simple attention, working memory, naming, repetition, comprehension, writing and constructional abilities. Scores range from 0 to 100 with lower values indicating greater impairment.|Baseline & 18 months|Intent-to-Treat Analysis Set with both baseline and month 18 assessments.||Scores on a scale||Standard Deviation|Mean
783488|NCT00818662|Secondary|Change From Baseline at 18 Months in Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Assessment|"The ADCS-CGIC is a validated categorical measure of change in a participant's clinical condition between baseline and follow-up visits; it is used to assess global clinical status. The ADCS CGIC score is based on direct examination of the participant and an interview of the caregiver. The rater should refer to the baseline ADCS-CGIC worksheets in making a rating.
A skilled and experienced clinician who is blinded to treatment assignment rates the participant on a 7-point Likert scale, ranging from 1 (marked improvement) to 7 (marked worsening).
Very much better
Much better
A little better
Same
A little worse
Much worse
Very much worse"|Baseline & 18 Months|Intent-to-Treat Analysis Set with both baseline and month 18 assessments.||participants|||Number
783489|NCT00818662|Secondary|Change From Baseline at 9 Months in Alzheimer’s Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Assessment|"The ADCS-CGIC is a validated categorical measure of change in a participant’s clinical condition between baseline and follow-up visits; it is used to assess global clinical status. The ADCS CGIC score is based on direct examination of the participant and an interview of the caregiver. The rater should refer to the baseline ADCS-CGIC worksheets in making a rating.
A skilled and experienced clinician who is blinded to treatment assignment rates the participant on a 7-point Likert scale, ranging from 1 (marked improvement) to 7 (marked worsening).
Very much better
Much better
A little better
Same
A little worse
Much worse
Very much worse"|Baseline & 9 Months|Intent-to-Treat Analysis Set with both baseline and month 9 assessments.||participants|||Number
783490|NCT00818662|Secondary|Change From Baseline at 9 Months in Alzheimer´s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)|"The ADCS-ADL scale is a validated tool to assess instrumental and basic activities of daily living based on a 23 item structured interview of the caregiver or qualified study partner.
Scores on the ADCS-ADL range from 0-78 with lower scores indicating greater impairment; hence decreases from baseline reflect potential functional deterioration."|Baseline & 9 Months|Intent-to-Treat Analysis Set with both baseline and month 9 assessments.||Scores on a scale||Standard Deviation|Mean
783491|NCT00818662|Secondary|Change From Baseline at 9 Months in the Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog)|"The ADAS-Cog is a validated psychometric instrument that evaluates memory (word recall, word recognition), attention, reasoning (following commands), language (naming, comprehension), orientation, ideational praxis (placing letter in envelope) and constructional praxis (copying geometric designs). This test was administered by experienced raters certified by Alzheimer's Disease Cooperative Study (ADCS) at each site.
Scores on the ADAS-Cog range from 0-70 with higher scores indicating greater impairment; hence increases from baseline reflect potential cognitive deterioration."|Baseline & 9 months|Intent-to-Treat Analysis Set with both baseline and month 9 assessments.||Scores on a scale||Standard Deviation|Mean
783492|NCT00818662|Primary|Change From Baseline at 18 Months in Alzheimer´s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)|"The ADCS-ADL scale is a validated tool to assess instrumental and basic activities of daily living based on a 23 item structured interview of the caregiver or qualified study partner.
Scores on the ADCS-ADL range from 0-78 with lower scores indicating greater impairment; hence decreases from baseline reflect potential functional deterioration."|Baseline & 18 Months|Intent-to-Treat Analysis Set with both baseline and month 18 assessments.||Scores on a scale||Standard Deviation|Mean
783493|NCT00818662|Primary|Change From Baseline at 18 Months in the Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog)|"The ADAS-Cog is a validated psychometric instrument that evaluates memory (word recall, word recognition), attention, reasoning (following commands), language (naming, comprehension), orientation, ideational praxis (placing letter in envelope) and constructional praxis (copying geometric designs). This test was administered by experienced raters certified by Alzheimer’s Disease Cooperative Study (ADCS) at each site.
Scores on the ADAS-Cog range from 0-70 with higher scores indicating greater impairment; hence increases from baseline reflect potential cognitive deterioration."|Baseline & 18 months|Intent-to-Treat Analysis Set with both baseline and month 18 assessments.||Scores on a scale||Standard Deviation|Mean
783494|NCT00818753|Secondary|Number of Participants With Bleeding Events|Bleeding is categorized using the TIMI criteria as major or minor bleeding. The time window for inclusion of bleeding events was up until 3 days post-procedure or discharge (whichever occurred first).|First administration until 7-14 days after PCI (Percutaneous Coronary Intervention)|Treated set. All randomised patients who were documented to have taken at least 1 dose of study drug.||participants|||Number
783495|NCT00818753|Secondary|Percentage of Participants Who Experienced Catheter Related Thrombi Not Resulting in Clinical Complications Including Guide-catheter (Wire) Thrombosis|Investigator reported outcome|From 22 to 165 minutes|Full analysis set. All patients who were treated with randomised medication and underwent a cardiac intervention||Percentage of participants|||Number
783496|NCT00818753|Secondary|Percentage of Participants Who Experienced Abrupt Vessel Closure, New Thrombus With Reduced Reflow or no Reflow|Investigator reported outcome|From 22 to 165 minutes|Full analysis set. All patients who were treated with randomised medication and underwent a cardiac intervention||Percentage of participants|||Number
783497|NCT00818753|Secondary|Percentage of Participants Who Experienced Catheter Related Thrombi Requiring Rescue Anticoagulation Therapy|Investigator reported outcome|From 22 to 165 minutes|Full analysis set. All patients who were treated with randomised medication and underwent a cardiac intervention||Percentage of participants|||Number
783498|NCT00818753|Primary|Percentage of Participants Who Require Anticoagulation and/or Have Clinical Signs of Catheter Related Thrombosis|Investigator reported outcome|From 22 to 165 minutes|Full analysis set (FAS). All patients who were treated with randomised medication and underwent a cardiac intervention||Percentage of participants|||Number
783499|NCT00818766|Secondary|All-Cause Mortality|All-cause mortality is the number of deaths that occurred during the study period, regardless of the cause.|Up to 28 days after surgery|ITT Population included all participants who were randomized and received their allocated intervention. 1 participant in the antibiotic arm and 2 participants in the placebo arm were randomized twice but are only counted once (per first randomization) in the ITT Population.||Participants|||Count of Participants
783500|NCT00818766|Secondary|Number of Participants With Allergic Reactions|The number of participants with an allergic reaction to a drug.|Up to 28 days after surgery|ITT Population included all participants who were randomized and received their allocated intervention. 1 participant in the antibiotic arm and 2 participants in the placebo arm were randomized twice but are only counted once (per first randomization) in the ITT Population.||Participants|||Count of Participants
783501|NCT00818766|Secondary|Time to Removal of Chest Tubes|Time to removal of chest tubes is the number of days from the time of chest tube placement to time they were removed.|From day of surgery to removal of chest tubes (up to 33 days)|ITT Population included all participants who were randomized and received their allocated intervention. 1 participant in the antibiotic arm and 2 participants in the placebo arm were randomized twice but are only counted once (per first randomization) in the ITT Population.||days||Full Range|Median
783502|NCT00818766|Secondary|Length of Hospital Stay|The length of hospital stay is the number of days the participant remained in the hospital.|From day of surgery to discharge (up to 35 days)|ITT Population included all participants who were randomized and received their allocated intervention. 1 participant in the antibiotic arm and 2 participants in the placebo arm were randomized twice but are only counted once (per first randomization) in the ITT Population.||days||Full Range|Median
783503|NCT00818766|Secondary|Number of Participants Who Needed Reoperation|The number of participants who needed reoperations for any reason from the time after the first surgery to the end of the 28-day follow-up period.|Up to 28 days after surgery|ITT Population included all participants who were randomized and received their allocated intervention. 1 participant in the antibiotic arm and 2 participants in the placebo arm were randomized twice but are only counted once (per first randomization) in the ITT Population.||Participants|||Count of Participants
783504|NCT00818766|Secondary|Number of Participants Who Received Additional Antibiotics for Any Reason Within 28 Days After Surgery|The number of participants who needed any additional non-study antibiotics for any reason after randomization.|Up to 28 days after surgery|ITT Population included all participants who were randomized and received their allocated intervention. 1 participant in the antibiotic arm and 2 participants in the placebo arm were randomized twice but are only counted once (per first randomization) in the ITT Population.||Participants|||Count of Participants
783505|NCT00818766|Primary|Number of Participants Who Experienced Clostridium (C) Difficile Colitis|"C. Difficile Colitis:
Positive for C difficile toxin assay results and any 1 of the following:
new diarrhea
ileus or toxic megacolon
leukopenia (WBC count of <4000/µL) or leukocytosis (WBC count of >11000/µL)
findings from sigmoidoscopy, colonoscopy, or histopathologic examination consistent with C difficile infection"|Up to 28 days after surgery|ITT Population included all participants who were randomized and received their allocated intervention. 1 participant in the antibiotic arm and 2 participants in the placebo arm were randomized twice but are only counted once (per first randomization) in the ITT Population.||Participants|||Count of Participants
783506|NCT00818766|Primary|Number of Participants Who Experienced Empyema|"Empyema:
Positive pleural culture result or purulence within the thoracic space and leukocytosis or fever (>38°C)."|Up to 28 days after surgery|ITT Population included all participants who were randomized and received their allocated intervention. 1 participant in the antibiotic arm and 2 participants in the placebo arm were randomized twice but are only counted once (per first randomization) in the ITT Population.||Participants|||Count of Participants
783507|NCT00818766|Primary|Number of Participants Who Experienced Pneumonia|"Pneumonia:
A new infiltrate on chest x-ray associated with at least three of the following:
fever (>38°C)
purulent sputum
leukopenia (white blood cell [WBC] count of <4000/µL) or leukocytosis (WBC count of >11000/µL)
sputum culture with pathogenic bacteria
increased oxygen requirements"|Up to 28 days after surgery|ITT Population included all participants who were randomized and received their allocated intervention. 1 participant in the antibiotic arm and 2 participants in the placebo arm were randomized twice but are only counted once (per first randomization) in the ITT Population.||Participants|||Count of Participants
783508|NCT00818766|Primary|Number of Participants Who Experienced Surgical Site Infection|"Surgical Site Infection:
Superficial surgical site infection - involves only skin or subcutaneous tissue around incision and has at least one of the following criteria:
purulent drainage
organisms isolated from aseptically obtained culture
pain or tenderness, localized swelling, redness or heat and the incision deliberately opened by a surgeon
diagnosis of a superficial wound infection by a surgeon
Deep surgical site infection - involves deep soft tissues e.g. fascia or muscle and has at least one of the following:
purulent drainage from the incision but not from the organ/space of the surgical site
deep incision spontaneously dehisces or deliberately opened by surgeon when patient has at least one of following signs or symptoms - fever (>38°C), localized pain or tenderness.
an abscess or evidence of infection involving incision is found on direct examination, histopathologic or radiographic examination
diagnosis of a deep wound infection"|Up to 28 days after surgery|ITT Population included all participants who were randomized and received their allocated intervention. 1 participant in the antibiotic arm and 2 participants in the placebo arm were randomized twice but are only counted once (per first randomization) in the ITT Population.||Participants|||Count of Participants
783509|NCT00818766|Primary|Number of Participants Who Experienced At Least One Postoperative Infectious Complication|Infectious complications include: surgical site infection, empyema, pneumonia, and the occurrence of Clostridium difficile colitis within 28 days of surgery. Participants are only counted once regardless of how many different infectious complications they had.|Up to 28 days after surgery|Intent-to-Treat (ITT) Population included all participants who were randomized and received their allocated intervention. 1 participant in the antibiotic arm and 2 participants in the placebo arm were randomized twice but are only counted once (per first randomization) in the ITT Population.||Participants|||Count of Participants
783515|NCT00818805|Secondary|Change in Total Score in Ocular Symptom Questionnaire||15-180 min.||||||
783516|NCT00818805|Primary|Change in “Ocular Itching” Score (5-point Scale) in Subjective Symptom Questionnaire|Ocular itching score was assessed using a 5 point scale, with 1 meaning no itching and 4 meaning worst itching.|0-180 minutes after entering the examination room|||Units on a scale||Standard Deviation|Mean
783517|NCT00818883|Secondary|Percentage of Participants Who Reached Their Trough, Sitting, Clinic Systolic and Diastolic Blood Pressure Targets, Defined as <140/90 mm Hg Without Diabetes or Chronic Kidney Disease or <130/80 mm Hg With Diabetes or Chronic Kidney Disease|Percentage of participants who achieve both a clinic systolic and diastolic blood pressure response measured at each week indicated, defined as <140/90 mm Hg for participants without diabetes or chronic kidney disease or <130/80 mm Hg for participants with diabetes or chronic kidney disease[GFR <60 mL/min/1.73 m2 or urinary albumin:creatinine ratio (UACR) >200 mg albumin/g creatinine at Screening.] Systolic/diastolic blood pressure is the average of the 3 serial trough sitting systolic/diastolic blood pressure measurements.|Week 2, Week 4, Week 6, Week 8 and Week 10.|Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.||percentage of participants|||Number
783540|NCT00818961|Secondary|Non-relapse Mortality at Day 100|patients are evaluable for their cause of death at Day 100|Day 100|36 patients underwent hematopoietic stem cell transplant and therefore were eligible for evaluation of non-relapse mortality at Day 100||participants|||Number
783541|NCT00818961|Secondary|Overall Survival at 1 Year|Evaluation of overall survival at 1 year (# of patients who are alive at 1 year post-transplant)|1 year|36 patients underwent hematopoietic stem cell transplant and therefore were eligible for evaluation of overall survival at one year post-transplant||participants|||Number
783518|NCT00818883|Secondary|Percentage of Participants Who Reached Their Trough, Sitting, Clinic Diastolic Blood Pressure Target, Defined as <90 mm Hg for Participants Without Diabetes or Chronic Kidney Disease or <80 mm Hg for Participants With Diabetes or Chronic Kidney Disease.|Percentage of participants who achieve a clinic diastolic blood pressure response measured at each week indicated, defined as <90 mm Hg for participants without diabetes or chronic kidney disease or <80 mm Hg for participants with diabetes or chronic kidney disease. Diastolic blood pressure is the average of the 3 serial trough sitting diastolic blood pressure measurements.|Week 2, Week 4, Week 6, Week 8 and Week 10.|Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.||percentage of participants|||Number
783519|NCT00818883|Secondary|Percentage of Participants Who Reached Their Trough, Sitting, Clinic Systolic Blood Pressure Targets, Defined as <140 mm Hg for Participants Without Diabetes or Chronic Kidney Disease or <130 mm Hg for Participants With Diabetes or Chronic Kidney Disease|Percentage of participants who achieve a clinic systolic blood pressure response measured at each week indicated, defined as <140mm Hg without diabetes or chronic kidney disease or <130/mm Hg with diabetes or chronic kidney disease. Systolic blood pressure is the average of the 3 serial trough sitting systolic blood pressure measurements.|Week 2, Week 4, Week 6, Week 8 and Week 10.|Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.||percentage of participants|||Number
783520|NCT00818883|Secondary|Change From Baseline in the Mean Diastolic Blood Pressure at 0 to 12 Hours After Dosing as Measured by Ambulatory Blood Pressure Monitoring.|The change in the 12-hour mean diastolic blood pressure measured at each visit including final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline, Week 6 and Week 10.|Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
783521|NCT00818883|Secondary|Change From Baseline in the Mean Systolic Blood Pressure at 0 to 12 Hours After Dosing as Measured by Ambulatory Blood Pressure Monitoring|The change in the 12-hour mean systolic blood pressure measured at each visit including final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline, Week 6 and Week 10.|Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
783522|NCT00818883|Secondary|Change From Baseline in the Mean Nighttime (12 AM to 6 AM) Diastolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean diastolic blood pressure measured at each visit indicated including final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline, Week 6 and Week 10.|Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
783523|NCT00818883|Secondary|Change From Baseline in the Mean Nighttime (12 AM to 6 AM) Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean systolic blood pressure measured at each visit indicated including final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline, Week 6 and Week 10.|Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
783524|NCT00818883|Secondary|Change From Baseline in the Mean Daytime (6 AM to 10 PM) Diastolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean diastolic blood pressure measured at each visit including final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline, Week 6 and Week 10.|Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
783525|NCT00818883|Secondary|Change From Baseline in the Mean Daytime (6 AM to 10 PM) Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean systolic blood pressure measured at each visit including final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline, Week 6 and Week 10.|Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
783542|NCT00818961|Primary|Survival at Day 100|Survival at Day 100|100 day|36 patients underwent hematopoietic stem cell transplant and therefore were eligible for evaluation of overall survival at 100 days||participants|||Number
783555|NCT00819039|Secondary|Number of Participants With Complete Response Up to 48 Hours Following Surgery in Study Part 2|Complete response was defined as no vomiting and no use of rescue medication in 0-48 hours post-surgery.|Up to 48 Hours|The Full Analysis Set (FAS) population was used for all efficacy evaluations and included those participants who received a full dose of active study therapy, had surgery, and had at least one post-treatment efficacy assessment.||Participants|||Number
783526|NCT00818883|Secondary|Change From Baseline in 24-hour Mean Diastolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean diastolic blood pressure measured at each visit indicated including final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline, Week 6 and Week 10.|Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
783527|NCT00818883|Secondary|Change From Baseline in 24-hour Mean Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean systolic blood pressure measured at each visit indicated including final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline, Week 6 and Week 10.|Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
783528|NCT00818883|Secondary|Change From Baseline in Mean Trough Diastolic Blood Pressure (22 to 24 Hours After Dosing) as Measured by Ambulatory Blood Pressure Monitoring.|The change in trough diastolic blood pressure measured at each week indicated including final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline, Week 6 and Week 10.|Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
783529|NCT00818883|Secondary|Change From Baseline in Mean Trough Systolic Blood Pressure (22 to 24 Hours After Dosing) as Measured by Ambulatory Blood Pressure Monitoring.|The change in trough systolic blood pressure measured at each week indicated including final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline, Week 6 and Week 10.|Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
783530|NCT00818883|Secondary|Change From Baseline in Trough, Sitting, Clinic Diastolic Blood Pressure|The change in sitting trough clinic diastolic blood pressure measured at each week indicated including final visit relative to baseline. Diastolic blood pressure is the average of the 3 serial trough sitting systolic blood pressure measurements.|Baseline, Week 6 and Week 10.|Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
783531|NCT00818883|Primary|Change From Baseline in Trough, Sitting, Clinic Systolic Blood Pressure|The change in sitting trough clinic systolic blood pressure measured at each week indicated including final visit relative to baseline. Systolic blood pressure is the average of the 3 serial trough sitting systolic blood pressure measurements.|Baseline, Week 6 and Week 10.|Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
783532|NCT00818961|Secondary|Number of Patients Experiencing Veno-occlusive Disease (VOD) Post-transplant|Patients will be evaluated up to 4 years post transplant|4 years|36 patients underwent hematopoietic stem cell transplant and therefore were eligible for evaluation of VOD post-transplant||participants|||Number
783533|NCT00818961|Secondary|Number of Patients Experiencing Chronic Graft Versus Host Disease||>100 days post-transplant|35 patients survive past 100 days post-transplant and therefore were eligible for evaluation of chronic graft versus host disease||participants|||Number
783534|NCT00818961|Secondary|Number of Patients Experiencing Grade 2-4 Acute Graft-versus-host Disease Post-transplant|patients experiencing acute graft versus host disease post-transplant|patients were followed for 2 years|36 patients underwent hematopoietic stem cell transplant and therefore were eligible for evaluation of acute graft versus host disease post-transplant.||participants|||Number
783535|NCT00818961|Secondary|Number of Patients Requiring the Use of Donor Leukocyte Infusion (DLI) for Early Mixed T-cell Chimerism|DLI is used for patients with mixed chimerism following transplant|Day 100|36 patients underwent hematopoietic stem cell transplant and therefore were eligible for donor leukocyte infusions for mixed chimerism following transplant||participants|||Number
783536|NCT00818961|Secondary|Platelet Engraftment|The number of patients experiencing platelet engraftment post-transplant|Day 100|36 patients underwent hematopoietic stem cell transplant and therefore were eligible for evaluation of platelet engraftment.||participants|||Number
783537|NCT00818961|Secondary|Neutrophil Recovery|The number of patients experiencing neutrophil recovery post transplant|Day 100|36 patients underwent hematopoietic stem cell transplant and therefore were eligible for evaluation of neutrophil recovery||participants|||Number
783538|NCT00818961|Secondary|Complete Donor Chimerism|Complete donor chimerism (defined as >/= 95% donor cells in peripheral blood CD3+ and CD33+ was measured.|2 years|36 patients underwent hematopoietic stem cell transplant and therefore were eligible for evaluation of donor chimerism||participants|||Number
783539|NCT00818961|Secondary|Non-relapse Mortality at 1 Year Post-transplant|Number of patients who died of non-relapse causes at one year. this is in clusive of all patients who were transplanted on study even though only 10 patients died at by 1 year time point. This outcome will be referenced in the donor chimerism outcome. Only 26/36 patients were eligible for this time point as that is all that were alive.|1 year|36 patients underwent hematopoietic stem cell transplant. 10 patients died prior to 1 year post-transplant and were eligible for evaluation of non-relapse mortality at 1 year post-transplant||participants|||Number
783543|NCT00819013|Secondary|Number of Participants With Seropositivity to Hepatitis B Core Antigen Pre- and Post-Vaccination 1 With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.|"Seropositivity with ELISA was defined as a Pre- or post-vaccination antibody titer ≥ 100. Seropositivity with the Commercial Kit method was defined as a positive pre- or post-vaccination response.
Seropositivity were assessed by means of enzyme linked immunosorbent assay (ELISA) and the Commercial Kit methods"|Day 0 and Day 15 through Month 10 Post-vaccination 1|Seropositivity to Hepatitis B core antigen was assessed in participants who had no detectable anti-M2e antibodies on Day 0, received injections on Days 0 and 30, completed the Day 60 visit, and had antibody assessments on Day 60, per-protocol population.||Participants|||Number
783544|NCT00819013|Secondary|Geometric Mean Titers (GMTs) of Anti-Hepatitis B Core Antibodies Using Immunoglobulin G (IgG) ELISA Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.|Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA)|Day 0 and Day 15 through Month 10 post-vaccination 1|Antibody responses were assessed in participants who had no detectable anti-M2e antibodies on Day 0, received injections on Days 0 and 30, completed the Day 60 visit, and had antibody assessments on Day 60, Per-Protocol Population.||1/diultion (1/dil)||95% Confidence Interval|Geometric Mean
783545|NCT00819013|Secondary|Geometric Mean Titer Ratios of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.|Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA).|Day 0 and Day 60 Post-vaccination 1|Geometric mean titers (GMTs) and GMT ratios of Anti-M2e antigen were assessed in participants who had no detectable anti-M2e antibodies on Day 0, received injections on Days 0 and 30, completed the Day 60 visit, and had antibody assessments on Day 60, per-protocol population.||Ratio||95% Confidence Interval|Geometric Mean
783546|NCT00819013|Secondary|Geometric Mean Titers of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.|"Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA).
A GMT value of 50.0 indicates a titer at or below the lowest limit of quantitation (LLOQ)."|Day 0 and Day 60 Post-vaccination 1|Geometric mean titers (GMTs) and GMT ratios of Anti-M2e antigen were assessed in participants who had no detectable anti-M2e antibodies on Day 0, received injections on Days 0 and 30, completed the Day 60 visit, and had antibody assessments on Day 60, per-protocol population.||1/dilution (1/dil)||95% Confidence Interval|Geometric Mean
783547|NCT00819013|Secondary|Number of Participants With Seroconversion to M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.|Seroconversion was defined as an antibody Titer ≥ 100. Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA)|Day 0 and Day 60 Post-vaccination 1|Seroconversion to M2e antigens were assessed in participants who had no detectable anti-M2e antibodies on Day 0, received injections on Days 0 and 30, completed the Day 60 visit, and had antibody assessments on Day 60, per-protocol population.||Participants|||Number
783548|NCT00819013|Primary|Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine.|"Antibody responses to the respective vaccines were assessed by means of enzyme linked immunosorbent assay (ELISA).
A GMT value of 50.0 indicates a titer at or below the lowest limit of quantitation (LLOQ)"|Day 15 through Month 10 Post-vaccination 1|Geometric mean titers of the respective vaccine antibodies were assessed in participants who had no detectable anti-M2e antibodies on Day 0, received injections on Days 0 and 30, completed the Day 60 visit, and had antibody assessments on Day 60, Per-protocol population; per-protocol population.||1/dilution (1/dil)||95% Confidence Interval|Geometric Mean
783549|NCT00819013|Primary|Number of Participants With Seroconversion to M2e Antigen During Initial Treatment and Follow Up Period After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine|Seroconversion was defined as an end point anti M2e antibody titer ≥ 100. Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA)|Day 15 through Month 10 Post-vaccination 1|Seroconversion to M2e antigen was assessed participants who had no detectable anti-M2e antibodies on Day 0, received injections on Days 0 and 30, completed the Day 60 visit, and had antibody assessments on Day 60, Per-protocol population.||Participants|||Number
783550|NCT00819013|Secondary|Number of Participants With Signs and Symptoms of Influenza After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.|Participants who reported signs and symptoms of influenza were tested using nasal pharyngeal swabs, with secretions cultured using susceptible tissue culture cell lines. Positive cultures were confirmed as influenza using immunofluorescence techniques with influenza strain specific antibodies.|Month 4 through Month 10 post-vaccination 1|Influenza signs and symptoms were assessed in participants who had no detectable anti-M2e antibodies on Day 0, received injections on Days 0 and 30, completed the Day 60 visit, and had antibody assessments on Day 60, Per-Protocol Population.||Participants|||Number
783551|NCT00819013|Primary|Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.||Day 0 through Day 60 post-vaccination 1|Laboratory parameters were assessed in participants who received the initial injection and had at least one post-baseline immunogenicity assessment, regardless of the time of follow-up or protocol deviations (Intent-to-treat Population).||Participants|||Number
783552|NCT00819013|Primary|Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.|Solicited Injection Site Adverse Events: Erythema, Induration, Pain, Pruritus, Swelling, Rash. Solicited Systemic Adverse Events: Lymph Node Pain, Pyrexia (Temperature), Chills, Constipation, Diarrhoea, Fatigue, Headache, Malaise, Myalgia, Nausea, Vomiting, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Creatinine Increased, Haemoglobin Decreased, Platelet Count Decreased, White Blood Cell Count Increased.|Day 0 through Day 7 post-vaccination|Safety assessments were on participants who received the initial injection and had at least one post-baseline immunogenicity assessment, regardless of the time of follow-up or protocol deviations - Intent to Treat Population.||Participants|||Number
783553|NCT00819013|Primary|Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine.||Day 0 through Day 60 post-vaccination|Safety assessments were on participants who received the initial injection and had at least one post-baseline immunogenicity assessment, regardless of the time of follow-up or protocol deviations - Intent to Treat Population.||Participants|||Number
783556|NCT00819039|Secondary|Number of Participants With No Vomiting Up to 48 Hours Following Surgery Ini Study Part 2||Up to 48 Hours|The Full Analysis Set (FAS) population was used for all efficacy evaluations and included those participants who received a full dose of active study therapy, had surgery, and had at least one post-treatment efficacy assessment.||Participants|||Number
783557|NCT00819039|Secondary|Number of Participants With Complete Response Up to 24 Hours Following Surgery in Study Part 2|Complete response was defined as no vomiting and no use of rescue medication in 0-24 hours post-surgery.|Up to 24 Hours|The Full Analysis Set (FAS) population was used for all efficacy evaluations and included those participants who received a full dose of active study therapy, had surgery, and had at least one post-treatment efficacy assessment.||Participants|||Number
783558|NCT00819039|Secondary|Number of Participants With No Vomiting Up to 24 Hours Following Surgery in Study Part 2||Up to 24 Hours|The Full Analysis Set (FAS) population was used for all efficacy evaluations and included those participants who received a full dose of active study therapy, had surgery, and had at least one post-treatment efficacy assessment.||Participants|||Number
783559|NCT00819039|Primary|Number of Participants Discontinuing Study Treatment Due to AEs||Day 1|The population consists of all participants that received at least one dose of study medication.||Participants|||Number
783560|NCT00819039|Primary|Number of Participants Experiencing Adverse Events (AEs)||Up to 21 Days Post-Surgery|The population consists of all participants that received at least one dose of study medication.||Participants|||Number
783561|NCT00819039|Primary|Plasma Concentration of Aprepitant at 48 Hours (C48 hr) Following a Single Oral Dose in Study Part 1|The mean plasma concentration of aprepitant was evaluated in participants at 48 hours following a single oral dose.|48 Hours Post-Dose|The population consisted of all participants that received at least one dose of study medication and for which C48 hr data were available.||ng/mL||Standard Deviation|Mean
783562|NCT00819039|Primary|Plasma Concentration of Aprepitant at 24 Hours (C24 hr) Following a Single Oral Dose in Study Part 1|Blood samples were collected from participants for the analysis of C24 hr at 24 hours after dosing. N/A indicates that >50% of measurements were below the lower level of quantitaion (LLOQ).|24 Hours Post-Dose|The population consisted of all participants that received at least one dose of study medication and for which C24 hr data were available.||ng/mL||Standard Deviation|Mean
783563|NCT00819039|Primary|Time to Maximum Plasma Concentration (Tmax) of Aprepitant Following a Single Oral Dose in Study Part 1|Blood samples were collected from participants for the analysis of Tmax up to 48 hours after dosing.|48 Hours Post-Dose|The population consisted of all participants that received at least one dose of study medication and for which Tmax data were available.||Hours||Full Range|Median
783564|NCT00819039|Primary|Maximum Plasma Concentration (Cmax) of Aprepitant Following a Single Oral Dose in Study Part 1|Blood samples were collected from participants for the analysis of Cmax up to 48 hours after dosing.|48 Hours Post-Dose|The population consisted of all participants that received at least one dose of study medication and for which Cmax data were available.||ng/mL||Standard Deviation|Mean
783565|NCT00819039|Primary|Area Under the Curve From 0-48 (AUC0-48) of Aprepitant Following a Single Oral Dose in Study Part 1|Blood samples of 0.5 mL were collected from participants for the analysis of AUC0-48 at specified time points: pre-dose, and 1, 2, 3, 4, 8, 12, 24, and 48 hours post aprepitant single dose.|Pre-dose, and 1, 2, 3, 4, 8, 12, 24, and 48 hours post-dose|The population consisted of all participants that received at least one dose of study medication and for which AUC0-48 data were available.||hr*ug/ml||Standard Deviation|Mean
783566|NCT00819052|Secondary|Trough Plasma Concentration|Trough plasma concentrations of Nevirapine at steady state after multiple oral administrations of Nevirapine treatments from day 1 (visit 2) to week 48 (visit 9).|Day 1 to week 48|All patients with evaluable PK data.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
783567|NCT00819052|Secondary|Genotypic Resistance Associated With Virologic Failure|"Genotypic resistance associated with virologic failure.
This endpoint was not analysed due to lack of data."|48 weeks|All patients in the treated set who experienced virologic failure.|||||
783568|NCT00819052|Secondary|Time to Loss of Virologic Response|Kaplan-Meier Estimates of time to loss of virologic response defined as the time between the start of treatment and the time of treatment failure, up to and including the time when the last patient was on treatment for 48 weeks.|48 weeks|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment.||days||95% Confidence Interval|Median
783569|NCT00819052|Secondary|New AIDS or AIDS-related Progression Event or Death||144 weeks|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment.||participants|||Number
783570|NCT00819052|Secondary|Occurence of Hepatic Events||144 weeks|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment.||participants|||Number
783571|NCT00819052|Secondary|Occurence of Rashes|drug-related rashes by severity|144 weeks|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment.||participants|||Number
783572|NCT00819052|Secondary|Changes in Safety Parameters Related to Treatment|Occurence of investigations related to treatment|until week 144|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment.||participants|||Number
783573|NCT00819052|Secondary|Change From Baseline in VL (HIV-1 Viral Load) at Each Visit||week 48, 60, 72, 84, 96, 108, 120, 132, 144, last available visit|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment, Observed Cases.||copies/mL||Standard Deviation|Mean
783574|NCT00819052|Secondary|Proportion of Virologic Response (Viral Load <400 Copies/mL) Trough Week 144|Endpoint was the number of patients with a sustained virologic response through week 144|week 144|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants present at week 144.||participants|||Number
783575|NCT00819052|Secondary|Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Last Available Visit, Observed Cases, Full Analysis Set Population||baseline, last available visit (up to 144 weeks)|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants with CD4 counts at baseline and last visit (up to 144 weeks).||cells/cubic millimeter||Standard Deviation|Mean
783576|NCT00819052|Secondary|Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 144, Observed Cases, Full Analysis Set Population||baseline, week 144|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants with CD4 counts at baseline and week 144.||cells/cubic millimeter||Standard Deviation|Mean
783577|NCT00819052|Secondary|Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 132, Observed Cases, Full Analysis Set Population||baseline, week 132|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants with CD4 counts at baseline and week 132.||cells/cubic millimeter||Standard Deviation|Mean
783578|NCT00819052|Secondary|Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 120, Observed Cases, Full Analysis Set Population||baseline, week 120|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants with CD4 counts at baseline and week 120.||cells/cubic millimeter||Standard Deviation|Mean
783579|NCT00819052|Secondary|Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 108, Observed Cases, Full Analysis Set Population||baseline, week 108|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants with CD4 counts at baseline and week 108.||cells/cubic millimeter||Standard Deviation|Mean
783580|NCT00819052|Secondary|Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 96, Observed Cases, Full Analysis Set Population||baseline, week 96|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants with CD4 counts at baseline and week 96.||cells/cubic millimeter||Standard Deviation|Mean
783581|NCT00819052|Secondary|Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 84, Observed Cases, Full Analysis Set Population||baseline, week 84|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants with CD4 counts at baseline and week 84.||cells/cubic millimeter||Standard Deviation|Mean
783582|NCT00819052|Secondary|Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 72, Observed Cases, Full Analysis Set Population||baseline, week 72|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants with CD4 counts at baseline and week 72.||cells/cubic millimeter||Standard Deviation|Mean
783583|NCT00819052|Secondary|Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 60, Observed Cases, Full Analysis Set Population||baseline, week 60|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants with CD4 counts at baseline and week 60.||cells/cubic millimeter||Standard Deviation|Mean
783584|NCT00819052|Secondary|Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 48, Observed Cases, Full Analysis Set Population||baseline, week 48|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants with CD4 counts at baseline and week 48.||cells/cubic millimeter||Standard Deviation|Mean
783585|NCT00819052|Secondary|Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population|Endpoint was the number of patients with a sustained virologic response at their last available visit|last available visit, up to 144 weeks|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to patients present at last visit (up to 144 weeks).||participants|||Number
783586|NCT00819052|Secondary|Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population|Endpoint was the number of patients with a sustained virologic response through week 144|week 144|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to patients present at week 144.||participants|||Number
783587|NCT00819052|Secondary|Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population|Endpoint was the number of patients with a sustained virologic response through week 132|week 132|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to patients present at week 132.||participants|||Number
783588|NCT00819052|Secondary|Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population|Endpoint was the number of patients with a sustained virologic response through week 120|week 120|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to patients present at week 120.||participants|||Number
783589|NCT00819052|Secondary|Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population|Endpoint was the number of patients with a sustained virologic response through week 108|week 108|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to patients present at week 108.||participants|||Number
783590|NCT00819052|Secondary|Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population|Endpoint was the number of patients with a sustained virologic response through week 96|week 96|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to patients present at week 96.||participants|||Number
783591|NCT00819052|Secondary|Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population|Endpoint was the number of patients with a sustained virologic response through week 84|week 84|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to patients present at week 84.||participants|||Number
783592|NCT00819052|Secondary|Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population|Endpoint was the number of patients with a sustained virologic response through week 72|week 72|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to patients present at week 72.||participants|||Number
783593|NCT00819052|Secondary|Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population|Endpoint was the number of patients with a sustained virologic response through week 60|week 60|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to patients present at week 60.||participants|||Number
783594|NCT00819052|Secondary|Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population|Endpoint was the number of patients with a sustained virologic response through week 48|week 48|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants present at week 48.||participants|||Number
783595|NCT00819052|Secondary|Comparison of CD4 Count (Cells/Cubic Millimeter) Change From Baseline at Week 24, Observed Cases, Full Analysis Set Population||baseline, week 24|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment.The population was restricted to participants who had CD4 count at baseline and week 24.||cells/cubic millimeter||Standard Error|Least Squares Mean
783596|NCT00819052|Secondary|Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 24, Observed Cases, Full Analysis Set Population||baseline, week 24|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants who had CD4 count at baseline and week 24.||cells/cubic millimeter||Standard Deviation|Mean
783597|NCT00819052|Secondary|Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 12, Observed Cases, Full Analysis Set Population||baseline, week 12|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants who had CD4 count at baseline and week 12.||cells/cubic millimeter||Standard Deviation|Mean
783598|NCT00819052|Secondary|Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 8, Observed Cases, Full Analysis Set Population||baseline, week 8|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants who had CD4 count at baseline and week 8.||cells/cubic millimeter||Standard Deviation|Mean
783599|NCT00819052|Secondary|Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 4, Observed Cases, Full Analysis Set Population||baseline, week 4|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants who had CD4 count at baseline and week 4.||cells/cubic millimeter||Standard Deviation|Mean
783600|NCT00819052|Secondary|Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 2, Observed Cases, Full Analysis Set Population||baseline, week 2|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants who had CD4 count at baseline and week 2.||cells/cubic millimeter||Standard Deviation|Mean
783601|NCT00819052|Secondary|Summary of CD4 Count (Cells/Cubic Millimeter) at Baseline, Full Analysis Set Population||week 0|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants who had CD4 count at baseline.||cells/cubic millimeter||Standard Deviation|Mean
783602|NCT00819052|Secondary|Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population||week 0 to 24|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment||proportion of participants|||Number
783603|NCT00819052|Secondary|Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population|Endpoint was the number of patients with a sustained virologic response through week 24|week 24|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment||participants|||Number
783604|NCT00819052|Secondary|Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population|Endpoint was the number of patients with a sustained virologic response through week 12|week 12|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment||participants|||Number
783605|NCT00819052|Secondary|Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population|Endpoint was the number of patients with a sustained virologic response through week 8|week 8|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment||participants|||Number
783606|NCT00819052|Secondary|Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population|Endpoint was the number of patients with a sustained virologic response through week 4|week 4|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment||participants|||Number
783607|NCT00819052|Secondary|Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population|Endpoint was the number of patients with a sustained virologic response through week 2|week 2|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment||participants|||Number
783608|NCT00819052|Primary|Comparison of Virologic Response at Week 24 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population|Primary endpoint was the number of patients with a sustained virologic response through week 24|week 24|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment||participants|||Number
783609|NCT00819091|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 12|Change from baseline reflects the Week 12 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG and previous anti-diabetic medication.|Baseline, week 12|Full Analysis Set includes all randomized patients with baseline and on-treatment value of FPG. Last observation carried forward (LOCF) was used as the imputation rule.||mg/dL||Standard Error|Least Squares Mean
783610|NCT00819091|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 6|Change from baseline reflects the Week 6 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG and previous anti-diabetic medication.|Baseline, week 6|Full Analysis Set includes all randomized patients with baseline and on-treatment value of FPG. Last observation carried forward (LOCF) was used as the imputation rule.||mg/dL||Standard Error|Least Squares Mean
783611|NCT00819091|Secondary|Mixed Model Repeated Measurements Analysis of Change From Baseline in HbA1c at Week 18|HbA1c is measured as a percent. The change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline, week 18|FAS patients. Mixed Model Repeated Measurements (MMRM) analysis of Observed Cases (OC).||percent||Standard Error|Least Squares Mean
783612|NCT00819091|Secondary|Mixed Model Repeated Measurements Analysis of Change From Baseline in HbA1c at Week 12|HbA1c is measured as a percent. The change from baseline reflects the Week 12 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline, week 12|FAS patients. Mixed Model Repeated Measurements (MMRM) analysis of Observed Cases (OC).||percent||Standard Error|Least Squares Mean
783613|NCT00819091|Secondary|Mixed Model Repeated Measurements Analysis of Change From Baseline in HbA1c at Week 6|HbA1c is measured as a percent. The change from baseline reflects the Week 6 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline, week 6|FAS patients. Mixed Model Repeated Measurements (MMRM) analysis of Observed Cases (OC).||percent||Standard Error|Least Squares Mean
783614|NCT00819091|Secondary|Percentage of Patients With HbA1c Lowering by at Least 0.5% From Baseline at Week 18|An efficacy response is defined as HbA1c lowered by 0.5% or more at 18 weeks. A non-response is defined as HbA1c not lowered by 0.5% or more at 18 weeks.|Baseline, week 18|FAS patients. Non-completers were considered as failure imputation (NCF).||percentage of participants|||Number
783615|NCT00819091|Secondary|Percentage of Patients With Absolute Efficacy Response (HbA1c < 6.5%) at Week 18|An absolute efficacy response is defined as HbA1c < 6.5% at 18 weeks. A non-response is defined as HbA1c >= 6.5% at 18 weeks.|week 18|FAS patients with baseline HbA1c >= 6.5%. Non-completers were considered as failure imputation (NCF).||percentage of participants|||Number
783616|NCT00819091|Secondary|Percentage of Patients With Absolute Efficacy Response (HbA1c < 7%) at Week 18|An absolute efficacy response is defined as HbA1c < 7.0% at 18 weeks. A non-response is defined as HbA1c >= 7.0% at 18 weeks.|week 18|FAS patients with baseline HbA1c >= 7.0%. Non-completers were considered as failure imputation (NCF).||Percentage of Patients|||Number
783617|NCT00819091|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 18|Change from baseline reflects the Week 18 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG and previous anti-diabetic medication.|Baseline, week 18|Full Analysis Set includes all randomized patients with baseline and on-treatment value of FPG. Last observation carried forward (LOCF) was used as the imputation rule.||mg/dL||Standard Error|Least Squares Mean
783618|NCT00819091|Primary|Change From Baseline in HbA1c (Glycosylated Hemoglobin) at Week 18|HbA1c is measured as a percent. The change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline, week 18|Full Analysis Set includes all randomized patients with baseline and on-treatment value of HbA1c. Last observation carried forward (LOCF) was used as the imputation rule.||percent||Standard Error|Least Squares Mean
783619|NCT00819156|Secondary|The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight|Vital sign and body weight values at the end of the trial are compared to baseline values. The table represents the number of patients in each group with normal baseline values and markedly abnormal end-of-study values.|Day 364|ITT population||participants|||Number
783620|NCT00819156|Secondary|The Number of Patients With Abnormal Liver Function Tests|The number of patients who had abnormal (defined as above upper limit of normal range(ULN)) alanine aminotransferase(ALT), aspartate aminotransferase levels, and bilirubin levels. Also includes the number of patients who had ALT increases >3x ULN, and patients with ALT increases >3x ULN with concurrent increases in bilirubin >1.5 ULN.|364 days|ITT population||participants|||Number
783621|NCT00819156|Secondary|Median Values for Follicle Stimulation Hormone||Day 0 (Baseline), Days 1, 3, 7, 14, and 364|ITT population||international units / liter||Full Range|Median
783622|NCT00819156|Secondary|Median Values for Serum Luteinizing Hormone||Day 0 (Baseline), Days 1, 3, 7, 14, and 364|ITT population||international units / liter||Full Range|Median
783623|NCT00819156|Secondary|Median Values of Di-Hydrotestosterone||Day 0 (Baseline), Days 1, 3, 7, 14, and 364|ITT population||picogram / milliliter||Full Range|Median
783624|NCT00819156|Secondary|Median Prostate-specific Antigen Levels||Day 0 (Baseline), Days 3, 7, 14, and 364|ITT population||nanogram / milliliter||Full Range|Median
783625|NCT00819156|Secondary|Median Serum Testosterone Levels||Day 0 (Baseline), Days 1,3,7,14, and 364|ITT population||nanogram/milliliter||Full Range|Median
783626|NCT00819156|Secondary|Days to Prostate-Specific Antigen Progression|Median days to prostate-specific antigen increase of >= 50 percent and >=5 nanograms/milliliter compared to nadir on two consecutive visits at least two weeks apart.|Day 0 (post dose) to Day 364|Number of patients with PSA progression in the six groups n=0,3,1,4,4,2. Since no patients in the 200/80 group experience PSA progression the Days to progression could not be calculated.||days||Full Range|Median
783627|NCT00819156|Secondary|Days to 90 Percent Reduction in Prostate-Specific Antigen|Median number of days after the first dose of Degarelix when the prostate-specific antigen levels fell to 90 percent of the baseline value.|Day 0 (post dose) to Day 364|ITT population||days||Full Range|Median
783628|NCT00819156|Secondary|Days to 50 Percent Reduction in Prostate-Specific Antigen|Median number of days after the first dose of Degarelix when the prostate-specific antigen levels fell to 50 percent of the baseline value.|Day 0 (post dose) to Day 364|ITT population||days||Full Range|Median
783629|NCT00819156|Secondary|Number of Patients With Testoterone <=0.5 Nanogram/Milliliter at Day 3.|The number of patients who achieved the <=0.5 nanogram/milliliter level for serum testosterone after 3 days.|Day 3|ITT population.||participants|||Number
783631|NCT00819156|Secondary|Number of Patients With Testosterone Level <=0.5 Nanogram/Milliliter From Day 28 to Day 364 for Patients With Testosterone <=0.5 Nanogram/Milliliter at Day 28|Number of patients who maintained a castration level of testosterone (<=0.5 Nanogram/Milliliter) while on a maintenance dose of Degarelix from Day 28 - 364.|Day 28 - 364|ITT population of patients with testoterone measurements <=0.5 nanogram/milliliter at Day 28.||participants|||Number
783632|NCT00819156|Primary|Number of Patients With Testosterone <=0.5 Nanograms/Milliliter From Day 28 to Day 364|Number of patients who achieved a testosterone level considered a castration level.|12 months|ITT population.||participants|||Number
783633|NCT00819182|Other Pre-specified|Intervention Adherence|Number of breathing practice sessions per participant over the 16 week study period.|16 weeks|||Total practice sessions in 16 weeks||Standard Deviation|Mean
783634|NCT00819182|Other Pre-specified|Intervention Performance|Physiological recordings of number of breaths per minute to verify correct performance of paced respiration for this participant group only. Assessment was conducted at the week 16 post-randomization timepoint.|16 weeks|||Breaths Per Minute||Standard Deviation|Mean
783635|NCT00819182|Other Pre-specified|Intervention Performance|Physiological recordings of number of breaths per minute to verify correct performance of paced respiration for this participant group only. Assessment was conducted in a single visit scheduled 2 weeks post-randomization for the paced respiration group.|2 weeks|||Breaths Per Minute||Standard Deviation|Mean
783636|NCT00819182|Primary|Hot Flash Bother|Self-reported rating using a scale from 0 (not at all bothersome) to 10 (extremely bothersome). Calculated as 24 hour averages at 16 week timepoint.|16 weeks|Analysis based on all randomized participants.||Scores on a scale||Standard Deviation|Mean
783637|NCT00819182|Primary|Hot Flash Severity|Self-reported rating using a scale from 0 (not at all severe) to 10 (extremely severe). Calculated as 24 hour averages at 16 week timepoint.|16 weeks|Analysis based on all randomized participants.||Scores on a scale||Standard Deviation|Mean
783638|NCT00819182|Secondary|Sleep Disturbance|Self-report using the Pittsburgh Sleep Quality Index which is composed of 19-items to assess sleep quality and disturbances during the past week. Scores range from 0-21 with higher scores indicating poorer sleep quality and more sleep disturbance.|16 weeks|||Global Sleep Disturbance Score||Standard Deviation|Mean
783639|NCT00819182|Secondary|Mood Disturbance|Self-report using the well-validated Profile of Mood States-Short Form questionnaire. Six subscales are computed. Total scores are computed using the formula Depression-Dejection + Tension-Anxiety + Anger-Hostility + Fatigue-Inertia + Confusion-Bewilderment + (24 - Vigor-Activity). Total scores range from 0 to 124 with higher scores indicating higher mood disturbance.|16 weeks|||Scores on a scale||Standard Deviation|Mean
783640|NCT00819182|Secondary|Perceived Control Over Hot Flashes|Self-report using well-validated, standardized questionnaire composed of 15 items with response option ratings of 1-4. Scores were summed with potential range of 15-60. Lower scores indicated less control over hot flashes; higher scores indicate higher perceived control over hot flashes.|16 weeks|Analysis based on all randomized participants.||Scores on a scale||Standard Deviation|Mean
783641|NCT00819182|Secondary|Hot Flash Related Daily Interference|Self-report using well-validated, standardized questionnaire. Subject rated interference on scale items from 0 to 10. Total score range was 0-100 with higher scores indicating greater interference with daily life.|16 weeks|Analysis based on all randomized participants.||Scores on a scale||Standard Deviation|Mean
783642|NCT00819182|Primary|Hot Flash Frequency|Prospective, real-time electronic diary used by participants for a minimum of 24 hours to a maximum of 7 days. Duration of use was determined by participant choice.|16 weeks|Analysis based on all randomized participants.||Hot flashes per 24 hr||Standard Deviation|Mean
783643|NCT00819234|Secondary|Number of Participants With Treatment Emergent Positive Anti-leptin Antibody Titers at Week 52 and at Follow up by Metreleptin Dose - Intent to Treat Population|Baseline refers to Day 1. If Day 1 value was missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 was used. Follow up occurred on Days 3 - 28 after treatment ended. Serum titer determinations for antibodies to metreleptin were made using a validated electrochemical luminescence (ECLA) bridging assay. Antibody titers were assessed according to the following dilutions: 0, 5, 25, 125, 625, 3125, 15625, and 78125. Participants were considered to have a positive titer to treatment-emergent antibodies to metreleptin at a given visit if they had a titer >=5 following a negative or missing titer at baseline or if they had a titer that had increased by at least 2 dilutions from a detectable level at baseline.|Baseline to end of treatment follow up|N for Week 52 presented above. For Follow up: N=18,58,68,11,7,8.||participants|||Number
783644|NCT00819234|Secondary|Number of Chemistry Laboratory Values of Potential Clinical Importance Observed From DFA102E Baseline to Week 52 - Intent to Treat Population|Baseline defined in study DFA102E as Week 28. Criteria for laboratory values of potential clinical importance for obese and overweight (BMI>=25 kg/m^2) participants: Total bilirubin High (H) > 2 mg/dL; Plasma or serum glucose fasting or non-fasting H > 200 mg/dL, low (L) < 60 mg/dL; Albumin L <2.5 g/dL; Creatine kinase H > 3*Upper limit of Normal (ULN); Sodium L <130 milliequivalents per liter (mEq/L), H > 150 mEq/L; potassium L<3.0 mEq/L, H> 5.5 mEq/L;bicarbonate L<18 mEq/L, H>35 mEq/L;calcium L <8mg/dL, H> 11 mg/dL; triglycerides H> 500 mg/dL; Cholesterol L < 100 mg/dL, H > 350 mg/dL; Alkaline phosphatase H > 3*ULN; Gamma-glutamyltransferase H>3*ULN; creatinine males > 1.6 mg/dL, females > 1.4 mg/dL; alanine aminotransferase H > 3*ULN; aspartate aminotransferase H > 3*ULN; urea nitrogen H > 45 mg/dL; uric acid males > 10.0 mg/dL, females > 8.0 mg/dL; Phosphorus L < 1.0 mg/dL H > 6.0 mg/dL. Laboratory values obtained at Weeks 28, 36, 44, and 52; number of values a|Baseline to Week 52|All Enrolled participants who received at least one injection of any study medication in Study DFA102E; had laboratory data available. Number analyzed presented above is at Week 52; Number analyzed at Week 28: N= 31, 35, 36, 28, 13, 14, 13, 29, 37, 37.||Number of Laboratory values|||Number
783645|NCT00819234|Secondary|Number of Hematology or Urinalysis Laboratory Values of Potential Clinical Importance Observed From Baseline of DFA102E to Week 52 - Intent to Treat Population|Baseline defined as Week 28 (first week of study DFA102E). Hematology: Hematocrit males <36%, females <30%. Hemoglobin males <12 g/dL, females <10 g/dL. White blood cell count (WBC) H >18,000/µL; L <1,500/µL. Urinalysis: Urine protein H >= 3+ or >= 500 mg/dL. Urine glucose H >= 3+ or >= 500 mg/dL. Urine ketones >= 3+ or Large. Laboratory values were obtained at Weeks 28, 36, 44, and 52. Numbers of values are cumulative across the extension|Baseline to Week 52|Enrolled and received at least 1 injection of any treatment; participants had laboratory data available; platelet counts: n=19 in second arm (not 20); n=20 in fourth arm (not 22); n=11 in fifth arm (not 12);||number of laboratory values|||Number
783646|NCT00819234|Secondary|Mean Change From DFA102 Screening at Week 52 in Study DFA102E for Electrocardiogram Parameters - Intent to Treat Population|A 12-Lead electrocardiogram (ECG) was obtained. The PR interval, which is the time from beginning of the P wave to the beginning of the QRS complex (Note: QRS complex is a name for the combination of 3 of the graphical deflections seen in an ECG); QRS interval, which is time from the beginning to the end of the QRS complex; QT interval (measure between Q wave and T wave in the heart's electrical cycle); and QT interval corrected for heart rate using Fridericia's formula (QTcF) were measured in milliseconds (msec).|Screening to Week 52|Enrolled and received at least 1 injection of any treatment; had ECG data available at Week 52.||msec||Standard Deviation|Mean
783647|NCT00819234|Secondary|Mean Change in Heart Rate From Baseline of DFA102 at Week 52 of DFA102E - Intent to Treat Population|Baseline refers to Day 1 of original study DFA102. If Day 1 value was missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 was used. Heart rate was measured while the participant was sitting and was measured in beats per minute (bpm).|Baseline to Week 52|Enrolled and received at least 1 injection of any treatment; had data available.||bpm||Standard Deviation|Mean
783648|NCT00819234|Secondary|Mean Change in Systolic and Diastolic Blood Pressure From Baseline of DFA102 at Week 52 of DFA102E - Intent to Treat Population|Baseline refers to Day 1 of original study DFA102. If Day 1 value was missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 was used. Blood pressure was taken while the participant was sitting and was measured in millimeters of mercury (mm Hg).|Baseline (Day 1) to Week 52|Enrolled and received at least 1 injection of any treatment; had data available.||mm Hg||Standard Deviation|Mean
783649|NCT00819234|Secondary|Total Trough Concentration of Plasma Leptin at Baseline and at Weeks 40, 52, and End of Treatment Follow up - Week 52 Stable Evaluable Population|Mean fasting plasma total leptin concentration (nanograms per milliliter; ng/mL) change from baseline over time by pooled metreleptin dose (sex, baseline BMI category, and baseline value). Baseline defined as Day 1 in DFA102 study and Week 28 in study DFA102E. If Day 1 value was missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 was used. Follow up occurred 3-28 days after end of treatment. Leptin concentrations were measured using a validated immunoenzymetric assay utilizing polyclonal capture antibody, monoclonal detection antibody, and colorimetric readout by Amylin Pharmaceuticals, Inc. Week 52 Stable Evaluable: Enrolled and received at least 1 injection of any treatment (ITT); treatment regimens same in both DFA102/DFA102E (stable); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock); no major deviations during original study/extension.|Baseline to end of treatment follow up|number (n) of participants who are Week 52 evaluable in a stable treatment sequence (received the same treatment in both DFA102 and DFA102E) and who had follow up data. Week 52 in Metreleptin 2.5 mg arm n=55 (all others n=56); Week 40 in Metreleptin 5 mg arm n=66 (all others n=68)||ng/mL||Standard Error|Geometric Mean
783650|NCT00819234|Secondary|Mean Absolute Change From Original Study DFA102 Screening to Week 52 in Extension Study DFA102E in the Epworth Sleepiness Scale (ESS) Total Score – Week 52 Evaluable Population|The Epworth Sleepiness Scale (ESS) is an eight-item questionnaire that assesses sleep propensity in daily situations of increasing sleepiness on a four-point scale with 0=would never doze and 3=high chance of dozing. Lower scores show improvement. Values were obtained for this questionnaire on Visit 3 in the screening period in DFA102 and at Weeks 28, 40, and 52 in DFA102E.|Screening to Week 52|Enrolled and received at least 1 injection of any treatment (ITT); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock); no major deviations during original study/extension. Additional exclusions based on clinical review of the data prior database lock.||units on a scale||Standard Deviation|Mean
783651|NCT00819234|Secondary|Mean Absolute Change From Original Study DFA102 Screening to Week 52 in Extension Study DFA102E in Hospital Anxiety and Depression Scale (HADS) Total Scores – Week 52 Evaluable Population|The HADS is a questionnaire that uses 14 items to assess both anxiety and depression over the past week. The odd numbered items constitute the anxiety subscale, and the even numbered items constitute the depression subscale. The individual response scores for each subscale component are added together to obtain the individual subscale scores. The minimum and maximum score for each subscale is 0 and 21, respectively. Lower scores show improvement. Values were obtained for this questionnaire on Visit 3 in the screening period in DFA102 and at Weeks 28, 40, and 52 in DFA102E.|Screening to Week 52|Enrolled and received at least 1 injection of any treatment (ITT); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock); no major deviations during original study/extension. Additional exclusions based on clinical review of the data prior database lock.||units on a scale||Standard Deviation|Mean
783652|NCT00819234|Secondary|Mean Absolute Change From Original Study DFA102 Screening to Week 52 in Extension Study DFA102E in Binge Eating Scale (BES) Total Score - Week 52 Evaluable Population|The Binge Eating Scale (BES) is a 16-item questionnaire that assesses the behavioral and cognitive correlates of binge eating, including participants' perceived self-control over eating behavior using a range of 1 to 4 with 1=positive perceptions and 4= negative perceptions. Lower scores show improvement. The minimum and maximum score for the BES instrument is 0 and 55, respectively; the higher the score the worse the outcome. Values were obtained for this questionnaire on Visit 3 in the screening period in DFA102 and at Weeks 28, 40, and 52 in DFA102E.|Screening to Week 52|Enrolled and received at least 1 injection of any treatment (ITT); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock); no major deviations during original study/extension. Additional exclusions based on clinical review of the data prior database lock.||units on a scale||Standard Deviation|Mean
783653|NCT00819234|Secondary|Mean Absolute Change From Original Study DFA102 Screening at Week 52 in Extension Study DFA102E in Susceptibility to Eating Questionnaire (SEQ) Item Scores – Week 52 Evaluable Population|The eating questionnaire is an exploratory measure of appetite, satiety, and perceived control over portion size using 10 items, with each response measured on a 100 mm visual analogue scale (VAS). Ranges vary from: Never to Very Often; Not at All Difficult to Extremely Difficult; Not at all Strong to Very Strong). Lower scores show improvement. The Eating Questionnaire instructed participants to rate their responses to these items over the past 7 days. Values were obtained for this questionnaire on Visit 3 in the screening period in DFA102 and at Weeks 28, 40, and 52 in DFA102E.|Screening to Week 52|Enrolled and received at least 1 injection of any treatment (ITT); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock); no major deviations during original study/extension. Additional exclusions based on clinical review of the data prior database lock.||units on a scale||Standard Deviation|Mean
783654|NCT00819234|Secondary|Number of Participants Achieving at Least 5%, 10% and 15% Body Weight Loss From Extension Study DFA102E Baseline (Week 28) to Week 52 - Week 52 Evaluable Population|Baseline in extension study was Week 28; if value was missing or after the first dose in DFA102E, the last available value on or prior to Week 28 was used. Percent change in body weight from baseline was categorized: Change greater than (>) 0% (Body weight gain); Change less than, equal to (<=) 0 to > -5% (No body weight change or body weight loss <5%); Change <= -5% (Body weight loss greater than, equal to (>=)5%); Change <= -5% to > -10% (Body weight loss >=5% and <10%); Change <= -10% (Body weight loss ≥10%); Change <= -10% to > -15% (Body weight loss >=10% and <15%); Change <= -15% (Body weight loss >=15%).|Baseline (Week 28) to Week 52|Participants analyzed had non-missing data at Week 52. Week 52 Evaluable Population: ITT participants (received at least 1 injection); remained in the study through Week 52; complied with the protocol (per sponsor prior to database lock); no major deviations; some may have been excluded based on a clinical review of the data prior to database lock.||participants|||Number
783655|NCT00819234|Secondary|Number of Participants Achieving at Least 5%, 10%, and 15% of Body Weight Loss From Original Study DFA102 Baseline to Week 52 in Extension Study DFA102E - Week 52 Evaluable Population|Baseline is Day 1 in original study DFA102. If Day 1 value was missing or after the first dose of drug, the last available value on or prior to Day 1 was used. Percent change in body weight from baseline was categorized: Change greater than (>) 0% (Body weight gain); Change less than, equal to (<=) 0 to > -5% (No body weight change or body weight loss <5%); Change <= -5% (Body weight loss greater than, equal to (>=)5%); Change <= -5% to > -10% (Body weight loss >=5% and <10%); Change <= -10% (Body weight loss ≥10%); Change <= -10% to > -15% (Body weight loss >=10% and <15%); Change <= -15% (Body weight loss >=15%).|Baseline (Day 1) to Week 52|Number analyzed with non-missing data at Week 52. Week 52 Evaluable Population: All ITT participants (received at least 1 injection);remained in the study through Week 52; complied with the protocol (per sponsor prior to database lock);no major deviations; some may have been excluded based on a clinical review of the data prior to database lock.||participants|||Number
783656|NCT00819234|Secondary|LS Mean Absolute Change From Baseline in Original Study DFA102 to Week 52 in Extension Study DFA102E in Total Insulin - Week 52 Evaluable Treatment Stable Population|Total insulin was measured in micro international units per milliliter (µIU/mL). Baseline is Day 1 in original study DFA102. If Day 1 value was missing or after the first dose of drug, the last available value on or prior to Day 1 was used. Week 52, treatment stable evaluable population: those participants who enrolled and received at least 1 injection of any treatment (ITT); treatment regimens same in both DFA102/DFA102E (stable); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock).|Baseline to Week 52|n=number of participants with non-missing data in each treatment group. ITT population (received at least 1 injection) with treatment regimens same in DFA102/DFA102E (stable treatment); completed Week 52; no major protocol deviations in DFA102/102E.||µIU/mL||95% Confidence Interval|Least Squares Mean
783657|NCT00819234|Secondary|LS Mean Absolute Change From Baseline in Original Study DFA102 to Week 52 in Extension Study DFA102E for Glucose and Lipids - Week 52 Evaluable Treatment Stable Population|Glucose, total cholesterol, triglycerides, low density lipoprotein (LDL), and high density lipoprotein (HDL) were measured in milligrams per deciliter (mg/dL). Baseline was Day 1 in original study DFA102, Week 52 was in extension study DFA102E. If Day 1 value was missing or after the first dose of drug, the last available value on or prior to Day 1 was used. Week 52, treatment stable evaluable population: those participants who enrolled and received at least 1 injection of any treatment (ITT); treatment regimens same in both DFA102/DFA102E (stable); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock).|Baseline (Day 1) to Week 52|n=number of participants with non-missing data in each treatment group by test. glucose n=20,20,27,19; total cholesterol n=21,20,27,19; triglycerides n=21,20,27,19; LDL/HDL n=21,20,27,19. ITT population with treatment regimens same in DFA102/DFA102E (stable); completed Week 52; no major protocol deviations in DFA102 or DFA102E.||mg/dL||95% Confidence Interval|Least Squares Mean
783658|NCT00819234|Secondary|LS Mean Percent Change in Body Weight From Baseline of Original Study DFA102 at Week 12, and at Weeks 28, 36, 44, and 52 in the Extension Study DFA102E - Week 52 Evaluable Treatment Stable Population|Baseline is Day 1 in study DFA102. If Day 1 value was missing or after the first dose of drug, the last available value on or prior to Day 1 was used. Baseline in the Extension Study was Week 28. Week 52, treatment stable evaluable population: those participants who enrolled and received at least 1 injection of any treatment (ITT); treatment regimens same in both DFA102/DFA102E (stable); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock).|Baseline to Week 52|n=number of participants with non-missing data at this visit in each treatment group. Week 12 n=21,20,27,19; Week 28 n=21,20,27,19; Week 36 n=21,20,27,19; Week 44 n=21,20,27,19; Week 52 n=21,20,27,19. ITT population with treatment regimens same in DFA102/DFA102E; completed Week 52; no major protocol deviations in DFA102/102E.||Percentage of change in weight||95% Confidence Interval|Least Squares Mean
783659|NCT00819234|Secondary|LS Mean Absolute Change in Waist Circumference From Baseline in the Original Study to Week 52 in the Extension Study - Week 52 Evaluable Stable Population|Baseline is the baseline in the original study DFA102 (Day 1). If Day 1 value was missing or after the first dose of drug, the last available value on or prior to Day 1 was used. Waist circumference was measured in centimeters (cm). Week 52, treatment stable evaluable population: those participants who enrolled and received at least 1 injection of any treatment (ITT); treatment regimens same in both DFA102/DFA102E (stable); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock); no major deviations during original study/extension. Additional exclusions based on clinical review of the data prior database lock.|Baseline to Week 52|n=number of participants with non-missing waist circumference data at this visit in each treatment group. Week 12 n=21,20,27,19; Week 28 n=21,20,26,19; Week 36 n=21,20,27,19; Week 44 n=20,20,27,19; Week 52 n=21,19,27,19.ITT population with treatment regimens same in DFA102/DFA102E; completed Week 52; no major protocol deviations in DFA102/102E.||cm||95% Confidence Interval|Least Squares Mean
783675|NCT00819286|Primary|CT Scan Evaluation of Sternal Bone Healing|Quantitative evaluation of sternal bone healing at 5 anatomical locations along the sternum using a 6 point quantitative scale (0= no healing and 5= complete healing)|3 and 6 Months|Patients were randomized to receive a CT scan at either 3 or 6 months. All patients who received a CT scan were included in the analysis.||units on a scale||Standard Deviation|Mean
783660|NCT00819234|Secondary|Fasting Total Leptin Concentration by Visit and Pooled Metreleptin Stable Treatment by Metreleptin Dose - Week 52 Stable Evaluable Population|Baseline is Day 1 in original study DFA102, baseline in DFA102E is Week 28. Follow up is 3 - 28 days after the end of treatment period. As total leptin is measured, placebo arm was not included in the evaluation. Fasting total leptin is measured in nanograms per milliliter (ng/mL). The assay for measuring total plasma leptin is not specific for metreleptin and detects both endogenous leptin and exogenous metreleptin.|Original Study Baseline to Extension Week 52 and follow up|Enrolled and received at least 1 injection of metreleptin; treatment regimens same in both DFA102/DFA102E (stable population); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock); no major deviations during original study/extension.||ng/mL||Standard Error|Geometric Mean
783661|NCT00819234|Secondary|LS Mean Absolute Change in Body Weight From Original Study Baseline (Day 1) at Weeks 12, 28, 36, 44, and 52 - Evaluable Treatment Stable Population|Original study DFA102 (NCT00673387) baseline refers to Visit 5 (Day 1). If Day 1 value was missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 was used. Weeks 12 and 28 were in original study (Week 28 was baseline for extension study), while Weeks 36, 44, and 52 were in the extension study. Body weight was measured in kilograms (kg).|Original baseline to Week 52|Enrolled and received at least 1 injection of any treatment (ITT); treatment regimens same in both DFA102/DFA102E (stable); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock); no major deviations during original study/extension. Additional exclusions based on clinical review of the data prior database lock.||kg||95% Confidence Interval|Least Squares Mean
783662|NCT00819234|Primary|LS Mean Percent Change in Body Weight From Original Study DFA102 (NCT00673387) Baseline (Day 1) at Week 52 in Extension Study DFA102E - Evaluable Treatment Stable Population|Original study DFA102 (NCT00673387) baseline refers to Visit 5 (Day 1). If Day 1 value was missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 was used. Least Squares (LS) Mean based on a repeated measures mixed model with treatment, sex, DFA102 baseline BMI category, nominal week, treatment by nominal week interaction as factors, and DFA102 baseline weight value as a covariate, with a heterogeneous compound symmetry error covariance structure within each treatment group. Stable population consists of all ITT participants (received at least one injection of treatment) who had the same treatment group assignment in Study DFA102 and Study DFA102E, ie, ITT participants who were in Study DFA102 treatment groups Placebo, Pramlintide 360 + Metreleptin 1.25, Pramlintide 360 + Metreleptin 2.5 and Pramlintide 360 + Metreleptin 5.0.|Original Study Baseline to Week 52|Enrolled and received at least 1 injection of any treatment (ITT); treatment regimens same in both DFA102/DFA102E (stable); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock); no major deviations during original study/extension. Additional exclusions based on clinical review of the data prior database lock.||percentage of change in weight||95% Confidence Interval|Least Squares Mean
783663|NCT00819247|Secondary|Percentage Change in Vital Signs and Body Weight|Percentage changes in vital signs (systolic and diastolic blood pressure and pulse) and body weight at the end of trial as compared to baseline.|Baseline and Six months|Safety population.||percentage||Full Range|Median
783664|NCT00819247|Secondary|The Number of Participants With Abnormal Liver Function Tests|The number of participants who had abnormal [defined as above upper limit of normal range (ULN)] alanine aminotransferase (ALT), participants with ALT increases > 3x ULN, and participants with ALT increases > 3x ULN with concurrent increases in bilirubin > 1.5 ULN.|Six months|Randomized (Safety) population||participants|||Number
783665|NCT00819247|Secondary|Number of Participants With Normal Prostate-specific Antigen Levels During the Study|The number of participants whose prostate-specific antigen levels at weeks 12 and 24 were <= 4 nanogram/millliliter (normal level).|Weeks 12, 24|Per Protocol Population||participants|||Number
783666|NCT00819247|Secondary|Number of Participants Who Met the Withdrawl Criteria for Prostate-specific Antigen|Participants who met at least one of the three criteria for inadequate response on prostate-specific antigen levels (PA). (1) >=25 percent and/or 50 nanogram/milliliter compared to baseline (2) reduction of <=50% compared to baseline at week 12 (3) increase of >=10 nanogram/milliliter compared to nadir from week 4.|Six months|per protocol population||participants|||Number
783667|NCT00819247|Secondary|Number of Participants Not Meeting a Testosterone Withdrawal Criterion Between Weeks 4-24|Participants with one testoterone value > 1.0 nanogram/millliliter or two consecutive values between 0.5-1.0 nanogram/milliliter were withdrawn from the study due to insufficient response.|Weeks 4-24|Per protocol population||participants|||Number
783668|NCT00819247|Secondary|Number of Participants With Testosterone < 0.5 Nanogram/Milliliter at All Visits Between Weeks 4-24||Weeks 4-24|Per protocol population||participants|||Number
783669|NCT00819247|Primary|Number of Participants With Testosterone <0.5 Nanogram/Milliliter||Weeks 1,2,4,8,12,16,20,24|Per protocol population||participants|||Number
783670|NCT00819260|Secondary|Hematoma|A collection of blood or uncontrolled bleeding that necessitates a return to the operating room in the first day after surgery.|first day after surgery|entire study population||participants|||Number
783671|NCT00819260|Secondary|Pain Level in Surgical Sites|An 11-point visual analog scale was used to obtain subjective pain levels from patients. 0 being no pain and 10 being worst pain imaginable.|first week after surgery|all study participants||units on a scale||Standard Deviation|Median
783672|NCT00819260|Secondary|Volume of Drainage in Surgical Drains|An index was created to allow comparison between patients whose drain indwell times were different. This was created by taking total volume of drainage per breast drain and dividing it by the number of hours the drain was in place. The units are milliliters per hour.|within one week of surgery|All participants in the study.||mL/hour||Standard Deviation|Median
783673|NCT00819260|Primary|Time for Operation|Time to complete the breast reduction per breast.|day of surgery|Women over the age of 18 who are not pregnant with symptomatic breast hypertrophy who underwent breast reduction surgery.||minutes||Standard Deviation|Median
783674|NCT00819286|Primary|Activity Based Total Visual Analog Pain Score|"Postoperative VAS pain scores (scale of 0-10 for each; 0= no pain, 10= worst pain imaginable) were evaluated as a function of resting, coughing, sneezing and general movement. The sum of these was used to derive an Activity Based Total Visual Analog Pain Score, (scale of 0-40; 0= no pain, 40= worst pain imaginable). For this primary endpoint analysis, the total score at 6 months was evaluated."|6 months|All patients with VAS pain data at 6 months were included in the analysis of the primary endpoint Activity Based Total Visual Analog Pain Score.||units on a scale||Standard Deviation|Mean
783705|NCT00819403|Secondary|Biomarkers of Inflammation||6 weeks|||mg/dl||Standard Deviation|Mean
783706|NCT00819403|Primary|Ex Vivo Effects of Treatment With Vytorin Versus Zocor for 6 Weeks on Platelet Alpha Thrombin PAR-1 Receptor Expression|Measured using whole blood flow cytometry|6 weeks|Based on power calculations||ng/dl||Standard Deviation|Mean
783707|NCT00819507|Secondary|Change in Transepidermal Water Loss|A measure of water flux out the skin using a small non-invasive probe. Values can range between 0-no water loss and over 100-severe water loss. This measure indicates the degree of skin barrier permeability with lower values indicating lower permeability (improved skin barrier function).|2 weeks|||G/m^2/hr||Standard Deviation|Mean
783708|NCT00819507|Primary|Change in Eczema Severity and Area Index|The eczema area and severity index (EAS I) is a validated composite score measuring physical signs of atopic dermatitis. The scale ranges from 0-72. The components measuring severity are four signs/symptoms of atopic dermatitis: erythema, population, excoriation and lichenification on a scale of 0-3 for each body of the four body regions (head/neck, trunk, arms, legs). The component measuring area is a body surface area measurement of each region. The area and severity of each body region is weighted based on size of region which are added together for the complete score. The score for each patient's with scores between 0 and 7 are considered mild ,between 7 and 21 are considered moderate, and greater than 21 are considered severe. In this study the change in EASI score between baseline and end of study (baseline EASI subtracted from end of study EASI) was calculated as a final outcome data point.|2 Weeks|||units||Standard Deviation|Mean
783709|NCT00819585|Secondary|Physician’s Global Assessment of Response to Therapy on a 5-point Likert Scale for Each Canakinumab Treatment Arm as Compared to Colchicine|To evaluate the efficacy of canakinumab as compared to colchicine with regards to the Physician’s global assessment of response to therapy on a 5-point Likert scale up to 16 weeks after randomization. The study physician made a global assessment of the patient’s response to treatment using a 5-point Likert scale: Very good, Good, Fair, Poor, Very poor. Physician’s global assessment was performed at the visits like Day 15 (Visit 3), Day 29 (Visit 4), Day 57 (Visit 5), Day 85 (Visit 6), Day 113 (Visit 7), and Day 141 (Visit 8). The category ‘Not assessed’ combines the missing and 'not done'.|At Day 15, Day 29, Day 57, Day 85, Day 113 and Day 141|The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one post-baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.||Participants|||Number
783710|NCT00819585|Primary|The Mean Number of Gout Flares for Each Treatment Arm|The primary efficacy variable was number of gout flares per participant per arm. Mean number of gout flares per treatment arm was derived from this primary variable. A gout flare was defined as an increase in participant-reported gout pain in the most affected joint during a gout attack. The target dose was defined as the minimum single dose that leads to at least the same expected efficacy as the expected efficacy of the comparator colchicine with respect to the mean number of gout flares. Four dose-response models (linear, linear in log-dose, logistic and emax) were chosen.|16 weeks after randomization|The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one post-baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.||gout flares||Standard Deviation|Mean
783729|NCT00819741|Secondary|Biochemistry: Alanine Aminotransferase (ASAT)|The number of subjects having a change in Aspartate Aminotransferase (ASAT) from 'Normal' or 'Abnormal, not clinically significant' to 'Abnormal, clinically significant'. 'Abnormal, Clinically significant' is an abnormality that suggests a disease and/or organ toxicity and is of a severity, which requires active management.|Week -2, week 16|Safety analysis set was defined as all randomised and exposed subjects.||Subjects|||Number
783711|NCT00819585|Secondary|Patient's Global Pain Intensity on 5-point Likert Scale up to Day 7 During All Gout Flares for Each Canakinumab Treatment Arm as Compared to Colchicine|"Participants were handed out a diary at baseline (Visit 2), Day 15 (Visit 3), Day 29 (Visit 4), Day 57 (Visit 5), Day 85 (Visit 6), Day 113 (Visit 7), and Day 141 (Visit 8) to record information on a daily basis during a gout flare. The patients were to score their current amount of acute gout pain in the joint on a 5-point Likert scale 1=None, 2=Mild, 3=Moderate, 4=Severe, 5=Extreme.
on the day of onset of the gout flare and
in the morning of the 6 following days"|up to 16 weeks after randomization|The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one post-baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.||Units on a scale||Standard Deviation|Mean
783712|NCT00819585|Secondary|Patient’s Global Pain Intensity on a 0-100 mm Visual Analog Scale (VAS) up to Day 7 During All Gout Flares for Each Canakinumab Treatment Arm as Compared to Colchicine|"The pain intensity on a 0-100 mm VAS scale, ranging from no pain (0) to unbearable pain (100) in the affected joint (Scores on the 100-mm linear scale were measured to the nearest millimeter from the left)
on the day of onset of the gout flare and
in the morning of the 6 following days"|up to 16 weeks after randomization|The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one post-baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.||Units on a scale||Standard Deviation|Mean
783713|NCT00819585|Secondary|The Percentage of Participants With Gout Flare at Different Time Points for Each Canakinumab Treatment Arm as Compared to Colchicine|A gout flare was defined as an increase in participant-reported gout pain in the most affected joint during a gout attack. The start of a gout flare was defined as that day when the patient reported increased pain in the most affected joint for the first time in the patient diary. The end of a gout flare was defined as the patient’s confirmation in the diary that the patient felt he/she had recovered from the gout flare or the acute gout pain had disappeared (whichever was first).|2 days, 4 days, 6 days, 2 weeks, 4 weeks, 6 weeks, 10 weeks and 16 weeks|The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one post-baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.||Percentage of participants||95% Confidence Interval|Number
783714|NCT00819585|Secondary|The Percentage of Participants With Gout Flares for Each Canakinumab Treatment Arm as Compared to Colchicine|The percentage of participants experiencing at least one gout flare within 16 weeks after randomization. A gout flare was defined as an increase in patient-reported gout pain in the most affected joint during a gout attack. The start of a gout flare was defined as that day when the patient reported increased pain in the most affected joint for the first time in the patient diary. The end of a gout flare was defined as the patient’s confirmation in the diary that the patient felt he/she had recovered from the gout flare or the acute gout pain had disappeared (whichever was first).|16 weeks after randomization|The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one post-baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.||Percentage of participants|||Number
783715|NCT00819585|Secondary|The Mean Number of Gout Flares for the Repeat Dose Regimen of Canakinumab as Compared to the Single Doses of Canakinumab||up to 16 weeks after randomization|The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one post-baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.||gout flares per patient||Standard Error|Least Squares Mean
783716|NCT00819637|Secondary|Pharmacokinetics of Arformoterol in This Clinical Setting||5 hours||||||
783717|NCT00819637|Secondary|All of the Primary and Secondary Endpoints Partitioned by the Presenting PFT in Quartiles and the Presenting S Albuterol Levels in Quartiles||5 hours||||||
783718|NCT00819637|Secondary|Percent of Patients in Each Group Requiring Additional Therapies After the First Hour of Study Drug Treatments|2 subjects were enrolled. Neither required additional asthma treatment after the 1st hour of study drug teatments.|5 hours||||||
783719|NCT00819637|Secondary|Percent of Responders (Defined as Those Discharged Following Treatment Who Did Not Require Additional Therapy in the ED)|The 2 subjects enrolled were both discharged home after study protocol completion, with no further treatment required in the ED setting.|5 hours||||||
783720|NCT00819637|Secondary|The Time Required to Achieve a FEV1 and PEFR > 60% Predicted for Each Dose (Individual and Cumulative)||5 hours||||||
783721|NCT00819637|Secondary|The Time to Onset of a 15% Improvement in FEV1 for Each Dose (Individual and Cumulative) and Total Dose of Study Medication to Reach This||5 hour||||||
783722|NCT00819637|Secondary|The Peak Change (Liters) and Peak Percent Change From Baseline in the FEV1 and PEFR (Absolute and Percent Predicted) Following Each Dose of Study Drug||1 hour||||||
783723|NCT00819637|Secondary|The Mean Change From Baseline in the FEV1 and PEFR (Absolute and Percent Predicted) Following Each Dose of Study Drug||1 hour||||||
783724|NCT00819637|Secondary|The Mean Percent Change From Baseline in the FEV1 and PEFR (Absolute and Percent Predicted) Following Each Dose of Study Drug||1 hour||||||
783725|NCT00819637|Primary|The Averaged Mean Percent Change From Baseline FEV1 and PEFR (Percent Predicted and Absolute) After the 3 Doses of Study Drug||1 hour|As the study was terminated with 2 subjects enrolled, those 2 subjects were used for the limited statistical analysis.||percent change||95% Confidence Interval|Median
783726|NCT00819637|Secondary|Number of Participants Treated With Arformoteral in Acute Asthma Exacerbation as a Measure of Safety and Tolerability.||5 hours||||||
783727|NCT00819637|Secondary|Most Effective Dose of Inhalation Arformoterol for Treating Acute Bronchospasm in Asthmatics by Evaluating the Averaged Mean Percent Change From Baseline % Predicted FEV1 After 3 Doses of Study Medication in Each of the 3 Groups||1 hour||||||
783728|NCT00819741|Secondary|Haematology: Haemoglobin|Haemoglobin was measured. The number of subjects having a change in Haemoglobin measurement from 'Normal' or 'Abnormal, not clinically significant' to 'Abnormal, clinically significant' 'Abnormal, Clinically significant' is an abnormality that suggests a disease and/or organ toxicity and is of a severity, which requires active management.|Week -2, week 16|Safety analysis set was defined as all randomised and exposed subjects.||Subjects|||Number
783730|NCT00819741|Secondary|Biochemistry: Alanine Aminotransferase (ALAT)|The number of subjects having a change in Alanine Aminotransferase (ALAT) from 'Normal' or 'Abnormal, not clinically significant' to 'Abnormal, clinically significant'. 'Abnormal, Clinically significant' is an abnormality that suggests a disease and/or organ toxicity and is of a severity, which requires active management.|Week -2, week 16|Safety analysis set was defined as all randomised and exposed subjects.||Subjects|||Number
783731|NCT00819741|Secondary|ECG (ElectroCardioGram)|The number of subjects having a electrocardiogram (ECG) that changed from 'Normal' or 'Abnormal, not clinically significant' to 'Abnormal, clinically significant'. 'Abnormal, Clinically significant' is an abnormality that suggests a disease and/or organ toxicity and is of a severity, which requires active management.|Week -2, week 16|Safety analysis set was defined as all randomised and exposed subjects.||Subjects|||Number
783732|NCT00819741|Secondary|Physical Examinations|The number of subjects having a physical examination event that changed from 'Normal' or 'Abnormal, not clinically significant' to 'Abnormal, clinically significant'. Physical examination included cardiovascular system, respiratory system, musculoskeletal system, nervous system and abdomen.|Week -2, week 16|Safety analysis set was defined as all randomised and exposed subjects.||Subjects|||Number
783733|NCT00819741|Secondary|Change in Blood Pressure|Calculated as the mean change in diastolic and systolic blood pressure after 16 weeks of treatment|Week 0, week 16|Safety analysis set was defined as all randomised and exposed subjects.||mmHg||Standard Deviation|Mean
783734|NCT00819741|Secondary|Hypoglycaemic Episodes|Number of hypoglycaemic episodes from Week 0 to Week 16, defined as major, minor or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|Weeks 0-16|Safety analysis set was defined as all randomised and exposed subjects.||episodes|||Number
783735|NCT00819741|Secondary|Change in 2-hour Postprandial Serum C-peptide|Calculated as an estimate of the mean change in 2-hour postprandial serum C-peptide after 16 weeks of treatment|Week 0, week 16|Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product. A total of 100 subjects (50 per study group) out of the total subjects were randomly selected in the trial. Four trial sites were selected for the subgroup study.||ng/ml||Standard Error|Least Squares Mean
783736|NCT00819741|Secondary|Change in Fasting Serum C-peptide|Calculated as an estimate of the mean change in fasting serum C-peptide after 16 weeks of treatment|Week 0, week 16|Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product. A total of 100 subjects (50 per study group) out of the total subjects were randomly selected in the trial. Four trial sites were selected for the subgroup study.||ng/ml||Standard Error|Least Squares Mean
783737|NCT00819741|Secondary|Change in 2-hour Postprandial Serum Insulin|Calculated as an estimate of the mean change in 2-hour postprandial serum insulin after 16 weeks of treatment.|Week 0, week 16|Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product. A total of 100 subjects (50 per study group) out of the total subjects were randomly selected in the trial. Four trial sites were selected for the subgroup study.||mU/L||Standard Error|Least Squares Mean
783738|NCT00819741|Secondary|Change in Fasting Serum Insulin|Calculated as an estimate of the mean change in fasting serum insulin after 16 weeks of treatment.|Week 0, week 16|Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product. A total of 100 subjects (50 per study group) out of the total subjects were randomly selected in the trial. Four trial sites were selected for the subgroup study.||mU/L||Standard Error|Least Squares Mean
783739|NCT00819741|Secondary|Change in 7-point Plasma Glucose Profile|Calculated as an estimate of the mean change in 7-point (before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, bedtime) plasma glucose profile after 16 weeks of treatment.|Week 0, week 16|Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product.||mmol/L||Standard Error|Least Squares Mean
783740|NCT00819741|Secondary|Change in 2-hour Postprandial Plasma Glucose|Calculated as an estimate of the mean change in 2-hour postprandial plasma glucose following a standard test meal after 16 weeks of treatment|Week 0, week 16|Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product.||mmol/L||Standard Error|Least Squares Mean
783741|NCT00819741|Secondary|Change in Fasting Plasma Glucose|Calculated as an estimate of the mean change in fasting plasma glucose after 16 weeks of treatment.|week 0, week 16|Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product.||mmol/L||Standard Error|Least Squares Mean
783742|NCT00819741|Primary|Change in Glycosylated Haemoglobin A1c (HbA1c)|Calculated as an estimate of the mean change in HbA1c after 16 weeks of treatment.|week -2 (screening), week 16|Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product.||percentage (%) of total haemoglobin||Standard Error|Least Squares Mean
783743|NCT00819767|Secondary|Change in Resting vs. Peak Heart Rate Systolic Blood Pressure (SBP) From Week 8 (End of Active Treatment) to 24-hours After a Missed Dose|The difference in resting vs. peak (85% of maximal predicted) heart rate (HR) SBP was calculated by measuring SBP before and during exercise on a standardized treadmill test, conducted according to the Bruce Protocol. The SBP at rest vs peak HR was recorded at Week 8 (end of active treatment) and Week 8 + 2 days (48-hrs after last dose; 24-hrs after missed dose); the change in rest vs. peak SBP between these timepoints is reported. The analysis included the rest to peak increase in SBP at baseline as a covariate.|Week 8 (Last dose; end of active treatment) and Week 8 + 2 days (48-hours after the last dose; 24 hours after a missed dose). Blood Pressure measurements were taken at rest and at peak heart rate at both timepoints.|The Full Analysis Set (FAS) consisted of all patients who were randomized and took at least one dose of study drug.||mmHg||Standard Error|Least Squares Mean
783790|NCT00820573|Primary|Objective: Comparisons of the Effects of Co-administration of Sitagliptin and Metformin Alone or in Combination Versus Placebo on Baseline Endogenous Glucose Production (EGP).|Baseline endogenous glucose production prior to a mixed meal tolerance test (placebo) and following 6 weeks of either sitagliptin, metformin or sitagliptin plus metformin combination therapy in all 16 participants|6 weeks|||mg/kg.min||Standard Error|Mean
783744|NCT00819767|Secondary|Change in Resting vs. Peak Heart Rate Systolic Blood Pressure (SBP) From Baseline to Week 8|The difference in resting vs. peak (85% of the maximal predicted) heart rate (HR) SBP was calculated by measuring SBP before and during exercise on a standardized treadmill test, conducted according to the Bruce Protocol. Treadmill speed and incline were increased every 3 minutes until the patient was exhausted or peak HR was reached. The SBP at rest vs peak HR was recorded at Baseline and at Week 8 (end of active treatment); the change in SBP between these timepoints is reported. The analysis included the rest to peak increase in SBP at baseline as a covariate.|Baseline and Week 8 (end of active treatment). Blood Pressure measurements were taken at rest and at peak heart rate at both timepoints.|The Full Analysis Set (FAS) consisted of all patients who were randomized and took at least one dose of study drug.||mmHg||Standard Error|Least Squares Mean
783745|NCT00819767|Primary|Change in Resting vs. Peak Heart Rate Systolic Blood Pressure (SBP) From Baseline to Week 8 After a Missed Dose|The difference in resting vs. peak (85% of maximal predicted) heart rate (HR) SBP was calculated by measuring SBP before and during exercise on a standardized treadmill test, conducted according to the Bruce Protocol. Treadmill speed and incline were increased every 3 minutes until the patient was exhausted or peak HR was reached. The SBP at rest vs peak HR was recorded at Baseline and at Week 8 + 2 days (24-hrs after a missed dose); the change in rest vs. peak SBP between these timepoints is reported. The analysis included the rest to peak increase in SBP at baseline as a covariate.|Baseline and Week 8 + 2 days (48-hours after the last dose; 24 hours after a missed dose). Blood Pressure measurements were taken at rest and at peak heart rate at both timepoints.|The Full Analysis Set (FAS) consisted of all patients who were randomized and took at least one dose of study drug. The Exercise Evaluable Set (EES) included all patients included in the FAS for whom the treadmill test values for SBP at peak were available at baseline and after a missed dose.||mmHg||Standard Error|Least Squares Mean
783746|NCT00819780|Secondary|Number of Participants With Adverse Events (AEs)|Severity was graded using Common Terminology Criteria for Adverse Events (CTCAE) v3.0, with the exception of some dermatology/skin adverse events that were graded using CTCAE v3.0 with modifications. Fatal adverse events are classified as grade 5. Serious adverse events include any event that is fatal, life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or other significant medical hazard. Treatment-related AEs were those that the investigator considered a reasonable possibility that might have been caused by study drug.|The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 8.0 months for Panitumumab Plus mFOLFOX arm and 7.3 months for Bevacizumab Plus mFOLFOX6 arm.|Safety analysis set, which included all randomized participants who received at least 1 dose of protocol treatment (ie, panitumumab, bevacizumab, or any component of mFOLFOX6).||participants|||Number
783747|NCT00819780|Secondary|Percentage of Participants With an Objective Response for Participants With Wild-type RAS / BRAF|Objective response was defined as having a confirmed complete response (CR) or partial response (PR) during first-line treatment, based on the investigator’s review of scans using a modified-RECIST v1.0. A complete or partial response was confirmed no less than 4-weeks after the criteria for response were first met. Complete Response: Disappearance of all target and non-target lesions and no new lesions. Partial Response: At least a 30% decrease in the sum of the longest diameter (SLD) of target lesions and no progression of non-target lesions and no new lesions, or the disappearance of all target lesions with persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease and no new lesions.|From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.|Wild-type RAS/BRAF Investigator Tumor Response Analysis Set, defined as the subset of participants in the Wild-type RAS/BRAF Efficacy Analysis Set who had at least 1 unidimensionally measurable lesion per modified RECIST 1.0 per the local investigator.||percentage of participants||95% Confidence Interval|Number
783748|NCT00819780|Secondary|Percentage of Participants With an Objective Response for Participants With Wild-type RAS|"Objective response was defined as having a confirmed complete response (CR) or partial response (PR) during first-line treatment, based on the investigator’s review of scans using a modified-RECIST v1.0. A complete or partial response was confirmed no less than 4-weeks after the criteria for response were first met.
Complete Response: Disappearance of all target and non-target lesions and no new lesions. Partial Response: At least a 30% decrease in the sum of the longest diameter (SLD) of target lesions and no progression of non-target lesions and no new lesions, or the disappearance of all target lesions with persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease and no new lesions."|From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.|Wild-type RAS Investigator Tumor Response Analysis Set, defined as the subset of participants in the Wild-type RAS Efficacy Analysis Set who had at least 1 unidimensionally measurable lesion per modified RECIST 1.0 per the local investigator.||percentage of participants||95% Confidence Interval|Number
783749|NCT00819780|Secondary|Overall Survival in Participants With Wild-type RAS / BRAF|Overall survival was defined as the time from randomization to the date of death, with participants alive or lost to follow-up at the analysis data cutoff date censored at their last contact date.|From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.|Wild-type RAS/BRAF Efficacy Analysis Set was defined as a subset of Wild-type KRAS Exon 2 Efficacy Analysis Set with wild-type KRAS exon 2, 3, and 4, NRAS exon 2, 3, 4, and BRAF exon 15.||months||95% Confidence Interval|Median
783750|NCT00819780|Secondary|Overall Survival in Participants With Wild-type RAS|Overall survival was defined as the time from randomization to the date of death, with participants alive or lost to follow-up at the analysis data cutoff date censored at their last contact date.|From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.|Wild-type RAS Efficacy Analysis Set, defined as a subset of Wild-type KRAS Exon 2 Efficacy Analysis Set including all randomized participants with wild-type KRAS exon 2, 3, 4, NRAS exon 2, 3, and 4.||months||95% Confidence Interval|Median
783791|NCT00820612|Primary|Post-ERCP Pancreatitis|Subjects were diagnosed with post-ERCP pancreatitis if they experienced new upper abdominal pain, pancreatic enzyme elevation at least three times the upper limit of normal 24 hours after the procedure, and hospitalization of at least two nights.|5 days|100% completed follow-up||participants|||Number
783792|NCT00820664|Secondary|Mean Gene Expression Intensity After 4 Weeks of Either 0.5 or 2 mg Estrace Compared to Placebo.||4 weeks||||||
783751|NCT00819780|Secondary|Progression-free Survival (PFS) in Participants With Wild-type RAS / V-raf Murine Sarcoma Viral Oncogene Homolog B1 (BRAF)|PFS was defined as the time from the date of randomization to the date of first disease progression, or death within 60 days after the last evaluable tumor assessment or randomization date (whichever was later). Participants not meeting the criteria by the cutoff date were censored at the last evaluable tumor assessment date. Tumor response was evaluated by the investigator per modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 every 8 weeks until radiographic disease progression. Progression is defined as at least a 20% increase in the size of target lesions, unequivocal progression of existing non-target lesions, or any new lesions.|From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.|Wild-type RAS/BRAF Efficacy Analysis Set was defined as a subset of Wild-type KRAS Exon 2 Efficacy Analysis Set with wild-type KRAS exon 2, 3, and 4, NRAS exon 2, 3, 4, and BRAF exon 15.||months||95% Confidence Interval|Median
783752|NCT00819780|Secondary|Progression-free Survival (PFS) in Participants With Wild-type Rat Sarcoma Viral Oncogene Homolog (RAS)|PFS was defined as the time from the date of randomization to the date of first disease progression, or death within 60 days after the last evaluable tumor assessment or randomization date (whichever was later). Participants not meeting the criteria by the cutoff date were censored at the last evaluable tumor assessment date. Tumor response was evaluated by the investigator per modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 every 8 weeks until radiographic disease progression. Progression is defined as at least a 20% increase in the size of target lesions, unequivocal progression of existing non-target lesions, or any new lesions.|From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.|Wild-type RAS Efficacy Analysis Set, defined as a subset of Wild-type KRAS Exon 2 Efficacy Analysis Set including all randomized participants with wild-type KRAS exon 2, 3, 4, NRAS exon 2, 3, and 4.||months||95% Confidence Interval|Median
783753|NCT00819780|Secondary|Resection Rate|The resection rate was defined as the percentage of participants with a surgical procedure that resulted in partial reduction or complete eradication of all metastatic disease.|From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.|Intent-to-treat analysis set||percentage of participants||95% Confidence Interval|Number
783754|NCT00819780|Secondary|Time to Initial Objective Response|For participants with a confirmed objective response, the time from randomization to the date of first confirmed objective response. Assessments are based on the investigator’s review of scans using a modified-RECIST v1.0. An objective response is defined as a best tumor response of complete or partial response. A complete or partial response was confirmed no less than 4-weeks after the criteria for response were first met.|From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.|Evaluable for Local Tumor Response Analysis Set: Responders||months||Inter-Quartile Range|Median
783755|NCT00819780|Secondary|Time to Disease Progression|Time to progression (TTP) is defined as the time from randomization to the date of radiologic disease progression per modified RECIST 1.0 criteria. Participants not meeting criteria for disease progression by the analysis data cutoff date were censored at their last evaluable disease assessment date. Progression is defined as at least a 20% increase in the size of target lesions, unequivocal progression of existing non-target lesions, or any new lesions.|From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.|Intent-to-treat analysis set||months||95% Confidence Interval|Median
783756|NCT00819780|Secondary|Duration of Response|For participants with a confirmed objective response, the time from first confirmed objective response to radiologic disease progression per modified RECIST 1.0 criteria or death. For participants who responded and have not progressed or died, duration of response was censored at their last evaluable disease assessment date.|From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.|Evaluable for Local Tumor Response Analysis Set: Responders||months||95% Confidence Interval|Median
783757|NCT00819780|Secondary|Percentage of Participants With an Objective Response|Objective response was defined as having a confirmed complete response (CR) or partial response (PR) during first-line treatment, based on the investigator’s review of scans using a modified-RECIST v1.0. A complete or partial response was confirmed no less than 4-weeks after the criteria for response were first met. Complete Response: Disappearance of all target and non-target lesions and no new lesions. Partial Response: At least a 30% decrease in the sum of the longest diameter (SLD) of target lesions and no progression of non-target lesions and no new lesions, or the disappearance of all target lesions with persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease and no new lesions.|From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.|Evaluable for Local Tumor Response Analysis Set, defined as the subset of participants in the ITT Analysis Set who had at least 1 unidimensionally measurable lesion per modified RECIST 1.0 per the local investigator.||percentage of participants||95% Confidence Interval|Number
783758|NCT00819780|Secondary|Overall Survival|Overall survival was defined as the time from randomization to the date of death, with participants alive or lost to follow-up at the analysis data cutoff date censored at their last contact date.|From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.|Intent-to-treat analysis set||months||95% Confidence Interval|Median
783759|NCT00819780|Primary|Progression-free Survival (PFS)|PFS was defined as the time from the date of randomization to the date of first disease progression, or death within 60 days after the last evaluable tumor assessment or randomization date (whichever was later). Participants not meeting the criteria by the cutoff date were censored at the last evaluable tumor assessment date. Tumor response was evaluated by the investigator per modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 every 8 weeks until radiographic disease progression. Progression is defined as at least a 20% increase in the size of target lesions, unequivocal progression of existing non-target lesions, or any new lesions.|From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.|Intent-to-treat (ITT) analysis set (all randomized participants)||months||95% Confidence Interval|Median
783760|NCT00819832|Primary|Phase 2: Change in CTCB From Baseline to Post-treatment||CTCB evaluation performed from baseline through surgery +24 hours to post 7 days (+/- 2 days)||||||
784096|NCT00822185|Secondary|Vatreptacog Alfa Clot Activity- Initial Volume of Distribution (VD)||during 1-2 days after drug administration|PK analysis set included all the subjects not violating the protocol in a manner that was judged to affect PK endpoint evaluation.||mL/kg||Geometric Coefficient of Variation|Geometric Mean
783761|NCT00819832|Primary|Phase 1: Time to Maximal Circulating Tumor Cell Burden (CTCB)|Increase in number of cancer cells in patient’s blood after standard kyphoplasty or vertebroplasty treatment of broken back bones that may have been caused by cancer measured by CTCB evaluation from peripheral blood (10cc) collected at 8 varying time points for a total of 100 cc collected over the 7 day period of time (10, 30, and 60 minutes, and then at 2 hours, and between 6-8 hours, 10-18 hours, 20-28 hours, and 7 days after the surgery).|Pre-procedure baseline blood draws through post surgery 24 hours followed at 7 days (+/- 2 days)|Study terminated by sponsor; No data analysis done on limited amount of data gathered.|||||
783762|NCT00819910|Secondary|Mean Levels of Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) at Initial Visit and Final Visit|The mean Levels of AST and ALT measured at initial visit (Day 0) and final visit (Week 12) annotated as AST 1, AST 12, and ALT 1 and ALT 12, respectively.|12 weeks from initial visit (day 0) to final visit (12 weeks)|||mg/dl||Standard Deviation|Mean
783763|NCT00819910|Secondary|Post-treatment Percent Change in Apolipoprotein A-I (Apo AI), Apolipoprotein A-II (Apo AII) and Apolipoprotein C-III (Apo CIII) Levels|Post-treatment median change in Apo AI, Apo AII and Apo CIII levels reported in mg/dL with Interquartile ranges provided|12 weeks from initial visit (day 0) to final visit (12 weeks)|||% Change||Inter-Quartile Range|Median
783764|NCT00819910|Secondary|Post-treatment Percent Change in Low-Density Lipoprotein (LDL) Levels|The reported percent change is the difference between LDL levels obtained on initial visit (day 0) and LDL levels obtained at final visit (week 12) as per protocol|12 weeks from initial visit (day 0) to final visit (12 weeks)|||% change||Standard Deviation|Mean
783765|NCT00819910|Secondary|Post-treatment Percent Change in High-Density Lipoprotein (HDL) Levels|The reported percent change is the difference between HDL levels obtained on initial visit (day 0) and HDL levels obtained at final visit (week 12) as per protocol|12 weeks from initial visit (day 0) to final visit (12 weeks)|||% change||Standard Deviation|Mean
783766|NCT00819910|Primary|Percent Change in Triglyceride (TG) Levels Post Treatment|The reported percent change is the difference between TG levels obtained on initial visit (day 0) and TG levels obtained at final visit (week 12) as per protocol|12 weeks from initial visit (day 0) to final visit (12 weeks)|Mean percent change post treatment ( unit %). TG was measured using mg/dL units||% change||Standard Deviation|Mean
783767|NCT00820222|Secondary|Number of Participants Expressing Glucocorticoid Receptor, Phosphatase and Tensin Homolog (PTEN), Phosphatidylinositide 3-kinase (PI3K)/AKT, Protein 53 (P53), Insulin-like Growth Factor-1 (IGF-1), and Genes Involved in Cell Cycle Regulation|Because the study terminated early, pharmacogenetic and biomarker analyses were not performed.|Baseline|ITT Population|||||
783768|NCT00820222|Secondary|Number of Participants With Qualitative and Quantitative Toxicities|"Qualitative and quantitative toxicities were measured as AEs. See the outcome measure entitled Number of participants with the indicated Grade 3 or Grade 4 Adverse Events (AEs) occurring in >=2 participants in either treatment arm and the AE module of this results summary for a list of AEs occurring in the study. An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment."|From the first dose of study medication until 30 days after the last dose of study treatment (average of 10 months)|Safety Population|||||
783769|NCT00820222|Secondary|Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events (AEs) Occurring in >=2 Participants in Either Treatment Arm|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The Investigator assessed whether the AE was related to study drug. AEs were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0=No AE or within normal limits; 1=Mild AE; 2=Moderate AE; 3=Severe and undesirable AE; 4=Life-threatening or disabling AE; 5=Death related to AE.|From the first dose of study medication until 30 days after the last dose of study treatment (average of 10 months)|Safety Population: all participants in the ITT Population who received at least one dose of investigational product, based on the actual treatment received if this differed from that to which the participant was randomized||participants|||Number
783770|NCT00820222|Secondary|Number of Participants With CNS Progression at Any Time|CNS progression was documented by a brain scan and was indicated by the investigator on the follow-up electronic Case Report Form. CNS relapse is defined as the appearance of >=1 enhancing lesion measuring >=6 mm on T1W MRI without CNS symptoms that were considered to be unequivocal based on all relevant radiological features (e.g., associated T2W signal abnormality); the appearance of any enhancing lesion on T1W MRI with CNS symptoms; unequivocal finding of leptomeningeal disease, with or without symptoms; and unequivocal finding of multifocal intraparenchymal lesions with or without symptoms. In the event of the appearance of a <6 mm lesions(s) without CNS lesions, or equivocal findings potentially suggesting leptomeningeal disease, these findings were followed with a subsequent scan within 6 weeks. If unequivocal progression was determined with the subsequent scan and/or CNS symptoms occurred, then CNS relapse crieria were met.|From the time of randomization until death due to any cause (average of 10 months)|M-ITT Population||participants|||Number
783771|NCT00820222|Secondary|Duration of Response|Duration of response is defined as the time from the first documented evidence of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of the LD of the target lesions, compared with the baseline sum LD) until the first documented sign of PD (at least a 20% increase in the sum of the LD of target lesions, compared with the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions) or death due to breast cancer. In the absence of confirmation of death, survival time was to be censored at the time of the last investigator contact.|From the time of the first documented confirmed complete or partial response until disease progression or death, if sooner (average of 10 months)|ITT Population. Only those participants with CR or PR showing PD or death due to breast cancer were analyzed.||months||95% Confidence Interval|Median
783820|NCT00797862|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Week 24|Systolic Blood pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and 24 weeks of study treatment. Analysis used a repeated measures ANCOVA model with treatment, visit and region as factors, treatment by visit interaction and baseline msSBP as a covariate.|Baseline to 24 weeks|The analysis population included participants in the Full Analysis Set, (randomized participants who received at least one dose of study drug) for whom efficacy data was available for this outcome measure.||mmHg||Standard Error|Least Squares Mean
783772|NCT00820222|Secondary|Number of Participants With Clinical Benefit (CB)|CB is defined as the number of participants with evidence of confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of the LD of the target lesions, compared with the baseline sum LD) at any time or stable disease (SD, neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD [defined as at least a 20% increase in the sum of the LD of target lesions, compared with the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions] based on investigator assessment), for at least 24 weeks.|From randomization until disease progression, death, or discontinuation from the study (average of 10 months)|ITT Population. Only those participants enrolled under protocol amendment 3 were required to have PR or CR confirmation. Those participants enrolled under protocol amendments 1 and 2 were considered to have a “confirmed” response at the time of the first PR or CR regardless of follow-up scans.||participants|||Number
783773|NCT00820222|Secondary|Number of Participants With Overall Response (OR), as Assessed by the Investigator|OR is defined as the number of participants with either a confirmed complete response (CR; disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of the LD of the target lesions, compared with the baseline sum LD). CR and PR were assessed per Response Evaluation Criteria in Solid Tumors (RECIST). To be assigned a status of PR or CR, a confirmatory disease assessment was to be performed 28 days (4 weeks) or greater after the criteria for response were first met. In addition, a bone scan must have been obtained to rule out the presence of new bone lesions or progression of existing bone lesions, even if the participant had no bone lesions present at Baseline. If a bone scan was performed at the time of initial response or near the time of response, the bone scan did not need to be repeated.|From randomization until disease progression, death, or discontinuation from the study (average of 10 months)|ITT Population. Only those participants enrolled under protocol amendment 3 were required to have PR or CR confirmation. Those participants enrolled under protocol amendments 1 and 2 were considered to have a “confirmed” response at the time of the first PR or CR regardless of follow-up scans.||participants|||Number
783774|NCT00820222|Secondary|Overall Survival|Overall survival is defined as the time from randomization until death due to any cause or to the date of censor. In the absence of confirmation of death, survival time was to be censored at the time of the last investigator contact.|From randomization until death due to any cause (average of 10 months)|ITT Population||months||95% Confidence Interval|Median
783775|NCT00820222|Secondary|Time to First CNS Progression, Defined as the Time From Randomization Until the Date of Documented CNS Progression as the First Site of Relapse|CNS relapse is defined as the appearance of >=1 enhancing lesion measuring >=6 mm on T1W MRI without CNS symptoms that were considered to be unequivocal based on all relevant radiological features (e.g., associated T2W signal abnormality); the appearance of any enhancing lesion on T1W MRI with CNS symptoms; unequivocal finding of leptomeningeal disease (defined as the dissemination of cancer throughout the spinal fluid), with or without symptoms; and unequivocal finding of multifocal intraparenchymal lesions with or without symptoms. In the event of the appearance of a <6 mm lesions(s) without CNS lesions, or equivocal findings potentially suggesting leptomeningeal disease, these findings were followed with a subsequent scan within 6 weeks. If unequivocal progression was determined with the subsequent scan and/or CNS symptoms occurred, then CNS relapse crieria were met.|From randomization until the date of documented CNS progression (average of 10 months)|M-ITT Population. Only those participants who had no Baseline CNS metastases and who had CNS progression by radiographic confirmation (per Response Evaluation Criteria in Solid Tumors, 1.0: a 20% increase in the sum of the longest diameter [LD] of target lesions or the appearance of >=1 new lesions) were included in this analysis.||months||Standard Deviation|Mean
783776|NCT00820222|Secondary|Progression Free Survival (PFS), as Assessed by the Investigator|PFS is defined as the interval between the date of randomization and the earliest date of progressive disease (PD), or death due to any cause. PD is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, compared with the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions based on investigator assessment of both CNS and non-CNS for response.|From randomization until disease progression, death, or discontinuation from the study (average of 10 months)|Intent-to-Treat (ITT) Population: all participants who were randomized to study treatment regardless of whether or not treatment was administered||months||95% Confidence Interval|Median
783777|NCT00820222|Primary|Number of Participants With Central Nervous System (CNS) Metastases (as Assessed by Independent Review) as the Site of First Relapse|CNS relapse is defined as the appearance of >=1 enhancing lesion measuring >=6 millimeters (mm) on T1Weighted (T1W) Magnetic Resonance Imaging (MRI) without CNS symptoms that were considered to be unequivocal based on all relevant radiological features (e.g., associated T2W signal abnormality); the appearance of any enhancing lesion on T1W MRI with CNS symptoms; unequivocal finding of leptomeningeal disease (defined as the dissemination of cancer throughout the spinal fluid), with or without symptoms; and unequivocal finding of multifocal intraparenchymal lesions with or without symptoms. In the event of the appearance of a <6 mm lesions(s) without CNS lesions, or equivocal findings potentially suggesting leptomeningeal disease, these findings were followed with a subsequent scan within 6 weeks. If unequivocal progression was determined with the subsequent scan and/or CNS symptoms occurred, then CNS relapse crieria were met.|From randomization until disease progression, death, or discontinuation from the study (average of 10 months)|Modified Intent-to-Treat (M-ITT) Population: all participants who were randomized to study treatment regardless of whether or not treatment was administered and who had no Baseline CNS metastases per Independent Review Committee (IRC) assessment||participants|||Number
783778|NCT00820248|Secondary|Overall Survival Rate|"Overall survival is defined as the time interval between the date of randomization to date of death from any cause (calculated in months). Otherwise, survival is censored at the last date that the patient is known to be alive.
Number of death and alive patients will be reported."|6.2 years|||Participants|||Count of Participants
783779|NCT00820248|Primary|Progression-free Survival (PFS) Rate|"The progression event is defined by first event of the following,
Local-regional progression or recurrence Distant metastasis Non-protocol RT, chemotherapy, or biologic therapy without documentation of the site of failure Surgery of primary site with tumour present/unknown Neck dissection with tumour present/unknown, > 15 weeks from end of RT Death due to study cancer or from unknown causes or any other reason
Number of patients with and without progression event will be reported."|6.2 years|||Participants|||Count of Participants
783780|NCT00820443|Secondary|Metal Ion Analysis; Unilateral Only; Serum Chromium|Serum cobalt and chromium are recommended as the optimal tests for evaluation of joint implant wear, patients with CoM implants have elevated serum chromium and cobalt concentrations. Clinically important implant wear is indicated when serum chromium exceeds 15 ng/mL and cobalt exceeds 10 ng/mL; these symptomatic patients are likely to have significant implant deterioration. serum cobalt and chromium are highest in the first year after implant. In subsequent years, and after run-in wear (initial wear of a hip implant that produces the greatest amount of metal ion release), cobalt and chromium concentrations decline, then reach steady state around 3 years after implant|24 months|Only Unilateral participants were collected the Metal Ion data, and due to missing values/assessments/data, not all of the unilateral participants had Metal Ion data at 24 months, only 44 of them were evaluated.||ug/L||Standard Deviation|Mean
783781|NCT00820443|Secondary|Metal Ion Analysis (Unilateral Only):Serum Cobalt|Serum cobalt and chromium are recommended as the optimal tests for evaluation of joint implant wear, patients with CoM implants have elevated serum chromium and cobalt concentrations. Clinically important implant wear is indicated when serum chromium exceeds 15 ng/mL and cobalt exceeds 10 ng/mL; these symptomatic patients are likely to have significant implant deterioration. serum cobalt and chromium are highest in the first year after implant. In subsequent years, and after run-in wear (initial wear of a hip implant that produces the greatest amount of metal ion release), cobalt and chromium concentrations decline, then reach steady state around 3 years after implant.|24 months|Only Unilateral participants were collected the Metal Ion data, and due to missing values/assessments/data, not all of the unilateral participants had Metal Ion data at 24 months, only 44 of them were evaluated.||ug/L||Standard Deviation|Mean
783782|NCT00820443|Secondary|WOMAC Raw Total Score|The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints The WOMAC measures five items for pain (score range 0–20), two for stiffness (score range 0–8), and 17 for functional limitation (score range 0–68). Physical functioning questions cover everyday activities such as stair use, standing up from a sitting or lying position, standing, bending, walking, getting in and out of a car, shopping, putting on or taking off socks, lying in bed, getting in or out of a bath, sitting, and heavy and light household duties Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations (range is 0-96).|24 months|Due to missing values/assessments/data, not all of the participants were evaluated at 24 months, only 175 participants were evaluated at 24 months.||units on a scale||Standard Deviation|Mean
783783|NCT00820443|Secondary|The Secondary Measures of the UCLA Functional Assessments|"UCLA: University of California LosAngeles Activity Score
UCLA score is a validated scoring system for hip replacement outcome, The single item UCLA scale asks patients to rate their activity level from 1 to 10, with 1 defined as “no physical activity” and 10 defined as “regular participation in impact sports”. The score is the higher the better."|24 months|Due to missing values/assessments/data, not all of the participants were evaluated at 24 months, only 177 participants were evaluated at 24 months.||units on a scale (10 points)||Standard Deviation|Mean
783784|NCT00820443|Primary|Primary Endpoint/Measures: Success at 24 Months|"The patient success definition is measured at the 24 month interval by the following:
Harris Hip Score (HHS) of > 80 • < 2mm radiolucency (width) in any Gruen (stem) or DeLee/Charnley (cup) zone and no more than mild pain.
No revision or removal of any part of the device for aseptic reasons prior to or on day 730 following the index surgical procedure.
A patient must meet all three criteria in the definition to be considered a success. A patient who does not meet all three criteria will be deemed a failure.
The Harris hip score, is used to measure the outcome of total hip arthroplasty. Eight sections on the HIP are rated by the patient: pain, distance walked, activities, public transportation, support, limp, stairs and sitting. Total scores are out of 100 and grouped as follows: 90 - 100 Excellent,80 - 90 Good,70 - 79 Fair,60 - 69 Poor.< 60 Failed.Any score above 60 is acceptable, although the higher the score, the better the patient's overall adjustment after the surgery"|24 Month|Patients with Harris Hip Score (HHS) of > 80 Because there isn't complete radiographic data,the composite primary outcome is not analyzed at 24 month as in protocol. Only the number of patients who has HHS score greater that 80 is entered.Due to missing values/assessments/data, not all of the participants were evaluated at 24 months, only 197.||participants|||Number
783785|NCT00820534|Secondary|Size of the Cold Sore|The size of the cold sore was measured as follows : a standardized photograph was taken before treatment and compared to a photograph taken 72 hours after the first treatment application. The difference was calculated for each participant within each treatment arm.|72 hours|||square mm||95% Confidence Interval|Mean
783786|NCT00820534|Primary|Clinical Assessment Performed by the Investigator and Skin Temperature at the Cold Sore.|Number of participants where the classical cold sore lesion was prevented at 72 hours after first treatment application.Lesion defined as having been prevented if clinical assessment is prodrome, macule or healed and skin temperature of the cold sore is negative (temperature difference of less than 0.5°C between initial site of cold sore and opposite side).|72 hours|||participants|||Number
783787|NCT00820573|Secondary|Changes in Plasma Glucose Post-MTT After Each Six Weeks of Therapy Compared to Baseline|The absolute values of mean plasma glucose post-meal (360 minutes)were determined after each specific 6 week treatment and these absolute values after each specific sequence therapy were compared amongst all groups.|360 min|power calculation based on previous data||mg/dl||Standard Error|Mean
783788|NCT00820573|Primary|Average of Plasma Glucose During Mixed Meal Tolerance Test (MTT) Compared to Baseline Plasma Glucose to Post Therapy (6-weeks).|The degree of suppression of baseline endogenous glucose production was measured in absolute values and as a percent of basal values at the end of each 6-week therapeutic period. The absolute values obtained in each sequence study group (both basal and post-meal) were compared amongst all groups.|6 weeks|power calculations with data from previous similar studies||mg/kg.min||Standard Error|Mean
783789|NCT00820573|Secondary|Fasting Plasma Glucose 6 Weeks After Therapy|Basal pasma glucose was determined with the glucose oxidase method after each specific 6 week treatment. The absolute values obtained of basal plasma glucose at the end of each 6-week therapeutic period in each sequence study group (both basal and post-meal) were compared amongst all groups.|6 weeks|All 16 participants were analyzed using ANOVA to compare results after each 6 week period of exposure to therapeutic agent(s)||mg/dl||Standard Error|Mean
783793|NCT00820664|Primary|Immunohistochemistry (IHC) Proliferative Effects Measurement|Ratio of the total number of positively stained cell nuclei to the total number of cell nuclei. Proliferating endometrial cells express the Ki-67 antigen. The ratio was converted to a percent proliferating cells by taking the number of Ki-67 positive stained nuclei in a given field and dividing by the total number of nuclei in that field and multiplying by 100. At least 5 high power fields were scored in this manner and an aggregate percent Ki-67 positive cells was reported. Square root transformation was taken to make it approximately normally distributed for an ANOVA model to apply.|4 weeks|Though 29 subjects were enrolled, only 20 subjects had biopsy samples that were deemed adequate for Ki-67 immunohistochemical analysis at Week 4.||Square root of % positive stained cells||95% Confidence Interval|Least Squares Mean
783794|NCT00820755|Primary|Percentage of Participants With 1-year Overall Survival|The OS time is defined as the time from trial inclusion to death. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whichever is earlier. Percentage of participants who were still alive until one year after the last participant was included (March 2010).|Time from trial inclusion to death or last day known to be alive, reported between day of first participant included, that is, Jan 2009 until one year after the last participant was included (March 2010)|ITT maintenance analysis set included all participants who were included in ITT (all the participants enrolled in this study) analysis set, judged to be progression-free (based on CT or MRI scan) by the Investigator and randomized to maintenance therapy.||percentage of participants||95% Confidence Interval|Number
783795|NCT00820755|Secondary|Percentage of Participants With Disease Control for the Whole Study Period|The disease control rate is defined as the percentage of participants having achieved complete response or partial response or stable disease as the unconfirmed best overall response according to IRC assessment in combination therapy phase and radiological assessments (based on RECIST Version 1.0 criteria) in the maintenance therapy phase.|Evaluations were performed every 2 cycles during combination therapy and 6-weekly during maintenance therapy period until progression and at end of both periods, reported between day of first participant included, Jan 2009 until cut-off date (17 Dec 2011)|ITT maintenance analysis set included all participants who were included in ITT (all the participants enrolled in this study) analysis set, judged to be progression-free (based on CT or MRI scan) by the Investigator and randomized to maintenance therapy.||percentage of participants||95% Confidence Interval|Number
783796|NCT00820755|Secondary|Percentage of Participants With Disease Control in the Combination Therapy Phase|The disease control rate is defined as the percentage of participants having achieved complete response or partial response or stable disease as the unconfirmed BOR according to IRC assessment.|Evaluations were performed every 2 cycles during combination therapy period until progression and at the end of combination therapy period, reported between day of first participant included, that is, Jan 2009, until cut-off date, (17 Dec 2011)|ITT analysis set included all participants enrolled in this study.||percentage of participants||95% Confidence Interval|Number
783797|NCT00820755|Secondary|Percentage of Participant With Best Unconfirmed Tumor Response for the Whole Study Period|The response rate is defined as the percentage of participants having achieved CR and PR as the BOR according to IRC assessment in combination therapy phase and radiological assessments (based on response evaluation criteria in solid tumors [RECIST] Version 1.0) in the maintenance therapy phase. As per RECIST v1.0 for target lesions and assessed by MRI: CR = Disappearance of all target lesions; PR = at least 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Evaluations were performed every 2 cycles during combination therapy and 6-weekly during maintenance therapy period until progression and at end of both periods, reported between day of first participant included, Jan 2009 until cut-off date (17 Dec 2011)|ITT maintenance analysis set included all participants who were included in ITT (all the participants enrolled in this study) analysis set, judged to be progression-free (based on CT or MRI scan) by the Investigator and randomized to maintenance therapy.||percentage of participants||95% Confidence Interval|Number
783798|NCT00820755|Secondary|Percentage of Participants With Best Unconfirmed Tumor Response in the Combination Therapy Phase|The response rate is defined as the percentage of participants having achieved complete response (CR) or partial response (PR) as the unconfirmed best overall response (BOR) according to centrally reviewed investigator assessments based on an independent review charter (IRC). As per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: CR = Disappearance of all target lesions; PR = at least 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Evaluations were performed every 2 cycles during combination therapy period until progression and at the end of combination therapy period, reported between day of first participant included, that is, Jan 2009, until cut-off date, (17 Dec 2011)|ITT analysis set included all participants enrolled in this study.||percentage of participants||95% Confidence Interval|Number
783799|NCT00820755|Secondary|Time to Treatment Failure (From Randomization to Cetuximab Maintenance Regimen Until Death)|Time from randomization in cetuximab maintenance regimen to date of either first occurrence of progression, discontinuation of treatment due to progression or adverse event, withdrawal of consent or lost to follow up, start of further anticancer therapy, or death, whichever is earlier. Participants without events are censored either at the time of their last drug intake, or on the day of randomization (Day 1 of maintenance therapy) if they received no study drug.|Time from randomization in cetuximab maintenance regimen to treatment failure or last drug intake, reported between day of first participant randomized, that is, May 2009 until cut-off date (17 Dec 2011)|ITT maintenance analysis set included all participants who were included in ITT (all the participants enrolled in this study) analysis set, judged to be progression-free (based on CT or MRI scan) by the Investigator and randomized to maintenance therapy.||months||95% Confidence Interval|Median
783800|NCT00820755|Secondary|Time to Treatment Failure|Time to treatment failure is defined as the time from trial inclusion to date of either first occurrence of progression, discontinuation of treatment due to progression or adverse event, withdrawal of consent or lost to follow up, start of further anticancer therapy, or death, whichever is earlier. Participants without events are censored either at the time of their last drug intake, or on the day of inclusion (Day 1) if they received no study drug.|Time from trial inclusion to treatment failure or last drug intake, reported between day of first participant included, that is, Jan 2009 until cut-off date (17 Dec 2011)|ITT maintenance analysis set included all participants who were included in ITT (all the participants enrolled in this study) analysis set, judged to be progression-free (based on CT or MRI scan) by the Investigator and randomized to maintenance therapy.||months||95% Confidence Interval|Median
783801|NCT00820755|Secondary|Overall Survival (OS) Time (From Randomization to Cetuximab Maintenance Regimen Until Death)|The OS time is defined as the time from randomization in cetuximab maintenance regimen to death. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whichever is earlier.|Time from randomization in cetuximab maintenance regimen to death or last day known to be alive, reported between day of first participant randomized, that is, May 2009 until cut-off date (17 Dec 2011)|ITT maintenance analysis set included all participants who were included in ITT (all the participants enrolled in this study) analysis set, judged to be progression-free (based on CT or MRI scan) by the Investigator and randomized to maintenance therapy.||months||95% Confidence Interval|Median
783802|NCT00820755|Primary|Overall Survival (OS) Time|The OS time is defined as the time from trial inclusion to death. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whichever is earlier.|Time from trial inclusion to death or last day known to be alive, reported between day of first participant included, that is, Jan 2009 until cut-off date (17 Dec 2011)|Intention-to-treat (ITT) maintenance analysis set included all participants who were included in ITT (all the participants enrolled in this study) analysis set, judged to be progression-free (based on computer tomography [CT] or magnetic resonance imaging [MRI] scan) by the Investigator and randomized to maintenance therapy.||months||95% Confidence Interval|Median
783803|NCT00820872|Primary|Proportion of Patients Experiencing Grade 3 or 4 Diarrhea as Measured by NCI CTCAE v3.0||Up to 10 years|All evaulable patients||percentage of patients|||Number
783804|NCT00797667|Primary|Percentage of Participants Who Had Study Drug Discontinued During the Study Due to an Adverse Event|Participants were assessed throughout the study for adverse events and recorded adverse events in a daily dairy. An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an adverse event. The percentage of participants who discontinued study was summarized.|up to 12 weeks|All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.||Percentage of Participants|||Number
783805|NCT00797667|Primary|Percentage of Participants Who Experienced an Adverse Event|Participants were assessed throughout the study for adverse events and recorded adverse events in a daily dairy. An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an adverse event.|up to 14 days after last dose of study drug (up to 12 weeks)|All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.||Percentage of Participants|||Number
783806|NCT00797667|Secondary|Change From Baseline in the Mean Number of Days Per Month Requiring Rescue Medication|Participants completed a diary each evening just before going to bed. Information recorded included: date of assessment, administration of study medication, medication to treat breakthrough migraines and other headaches, associated symptoms, duration of headache pain, headache severity, and side effects. Participants use of medication to treat a breakthrough migraine/headache was considered rescue medication. The number of days per month requiring rescue medication was calculated.|Baseline and Week 12|Full Analysis Set (FAS), which included all randomized patients who took at least one dose of study medication and had at least one post-randomization efficacy measurement.||Days per month||95% Confidence Interval|Mean
783807|NCT00797667|Secondary|Change From Baseline in the Mean Monthly Migraine Attacks|Participants entered information about the number of migraine headaches, symptoms, headache pain duration and severity, use of medication, and side effects into a diary each evening just before going to bed. This information was used to determine the mean monthly migraine days; a migraine day was defined as any day in which a qualified headache was accompanied with associated symptoms.( i.e., aura, photophobia, phonophobia, nausea, or vomiting) started, ended, or recurred. A migraine attack was defined as any migraine headache that occurs within 2 consecutive calendar days. Pain persisting for more than 2 days after its initial onset was considered a new, distinct migraine attack. The number of migraine attacks that occurred per month was calculated. Mean monthly rate was adjusted to 28 days.|Baseline and Week 12|Full Analysis Set (FAS), which included all randomized patients who took at least one dose of study medication and had at least one post-randomization efficacy measurement.||attacks per month||95% Confidence Interval|Mean
783808|NCT00797667|Secondary|Percentage of Participants With at Least a 50% Reduction in Mean Monthly Headache Days|Participants entered information about the number of migraine headaches, symptoms, headache pain duration and severity, use of medication, and side effects into a diary each evening just before going to bed. This information was used to determine the mean monthly headache days; a headache day was defined as any day in which a qualified headache (>=30 minute duration or requiring acute treatment) started, ended, or recurred. Headache pain persisting for more than 1 calendar day after initial onset was considered an occurrence of multiple distinct headache days. Mean monthly rate was adjusted to 28 days. The percentage of participants who had at least a 50% reduction in mean monthly headache days during the 12 weeks treatment period was summarized|Week 12|Full Analysis Set (FAS), which included all randomized patients who took at least one dose of study medication and had at least one post-randomization efficacy measurement.||Percentage of Participants||95% Confidence Interval|Number
783838|NCT00814138|Secondary|MG-ADL 12 Month Change|The MG-ADL is an 8 item scale developed to assess myasthenia gravis symptoms. Score will range from 0 (normal - no MG symptoms) to 24 (severe MG symptoms)|Change from Baseline to Month 12|||units on a scale||95% Confidence Interval|Mean
784587|NCT00824746|Secondary|Progression - Free Survival of Patients Retreated With Gefitinib|Progression is defined, using RECIST (V1.1), as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline using CT scan every 8 weeks.|two year|||days||95% Confidence Interval|Median
783809|NCT00797667|Primary|Change From Baseline in Mean Monthly Migraine Days|Participants entered information about the number of migraine headaches, symptoms, headache pain duration and severity, use of medication, and side effects into a diary each evening just before going to bed. This information was used to determine the mean monthly migraine days; a migraine day was defined as any day in which a qualified headache( i.e., aura, photophobia, phonophobia, nausea, or vomiting) started, ended, or recurred. Migraine pain persisting for more than 1 calendar day after initial onset was considered an occurrence of multiple distinct migraine days. Mean monthly rate was adjusted to 28 days.|Baseline and Week 12|Full Analysis Set (FAS), which included all randomized patients who took at least one dose of study medication and had at least one post-randomization efficacy measurement.||Days per month||95% Confidence Interval|Mean
783810|NCT00797667|Primary|Change From Baseline in Mean Monthly Headache Days|Participants entered information about the number of migraine headaches, symptoms, headache pain duration and severity, use of medication, and side effects into a diary each evening just before going to bed. This information was used to determine the mean monthly headache days; a headache day was defined as any day in which a qualified headache (>=30 minute duration or requiring acute treatment) started, ended, or recurred. Headache pain persisting for more than 1 calendar day after initial onset was considered an occurrence of multiple distinct headache days. Mean monthly rate was adjusted to 28 days.|Baseline and Week 12|Full Analysis Set (FAS), which included all randomized patients who took at least one dose of study medication and had at least one post-randomization efficacy measurement.||Days per month||95% Confidence Interval|Mean
783811|NCT00797797|Secondary|Change From Baseline in Visual Analog Scale (VAS) 1-week Pain Recall at End of Study|The secondary efficacy measure was the change from Visit 2 (Week 0) in the 1-week pain recall at Visit 6 (Week 11) or End of Study, measured using a 100-mm VAS assessment of pain (0 indicating no pain and 100 indicating the worst possible pain).|Baseline (0 weeks) and End of Randomized Treatment Period (11 weeks)|||mm||Standard Error|Least Squares Mean
783812|NCT00797797|Primary|Patient Global Impression of Change (PGIC) Responder Rate at End of Study|The primary efficacy parameter was the PGIC responder rate, defined as the percentage of patients who rated themselves as “very much improved” or “much improved” (ie, having a score of 1 or 2 on the 7-point scale) for the PGIC at end of study (Visit 6 or Early Termination) compared to Visit 1.|End of Randomized treatment period (11 weeks)|All efficacy analyses are based on the Intent-to-Treat population, defined as all randomized patients who received at least one dose of randomized study drug and had at least one post-baseline PGIC assessment.||participants|||Number
783813|NCT00797823|Secondary|Percent of Time Venous Blood Glucose <70 mg/dl||1 year|||percent of time||Standard Error|Mean
783814|NCT00797823|Primary|Effectiveness of Closed Loop Diabetes Control|Effectiveness of closed loop diabetes control will be measured by mean glucose.|1 year|The number of participants for analysis was determined was per protocol.||mg/dl||Standard Error|Mean
783815|NCT00797862|Post-Hoc|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Week 32|Systolic Blood pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and 32 weeks of study treatment. Change at week 32 used a separate repeated measures ANCOVA model containing Week 8, 16, 24 & 32 data. Treatment, visit and region were factors in the model, treatment by visit interaction and baseline msSBP was a covariate.|Baseline to 32 weeks|The analysis population included participants in the Full Analysis Set, (randomized participants who received at least one dose of study drug) for whom efficacy data was available for this outcome measure.||mmHg||Standard Error|Least Squares Mean
783816|NCT00797862|Secondary|Percentage of Participants Achieving Overall Blood Pressure Control at 8, 16, 24 and 32 Weeks Endpoints|Systolic & Diastolic Blood Pressure were measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and after 8, 16 , 24 and 32 weeks. Outcome is reported as percentage of participants achieving overall blood pressure control (msSBP <140 mmHg and msDBP <90 mmHg) at weeks 8, 16, 24 & 32 endpoints.|Baseline to week 8, 16, 24 and 32 endpoints|The analysis population included participants in the Full Analysis Set, (randomized participants who received at least one dose of study drug) for whom efficacy data was available for this outcome measure. Last post-baseline observation was carried forward to each visit for the analysis of blood pressure control.||Percentage of Participants|||Number
783817|NCT00797862|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Week 24|Diastolic Blood pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and 24 weeks of study treatment. Analysis used a repeated measures ANCOVA model with treatment, visit and region, as factors, treatment by visit interaction and baseline msDBP as a covariate.|Baseline to 24 weeks|The analysis population included participants in the Full Analysis Set, (randomized participants who received at least one dose of study drug) for whom efficacy data was available for this outcome measure.||mmHg||Standard Error|Least Squares Mean
783818|NCT00797862|Secondary|Overall Mean Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) Over 8, 16, and 24 Weeks|Diastolic Blood pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and over 8, 16 and 24 weeks of study treatment. The overall mean change in msDBP from baseline was estimated over three time points: Week 8, Week 16, and Week 24. Analysis used a repeated measures ANCOVA model with treatment, visit and regions as factors, treatment by visit interaction and baseline msDBP as a covariate.|Baseline, 8 weeks, 16 weeks and 24 weeks|The analysis population included participants in the Full Analysis Set, (randomized participants who received at least one dose of study drug) for whom efficacy data was available for this outcome measure.||mmHg||Standard Error|Least Squares Mean
783819|NCT00797862|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Week 32|Diastolic Blood Pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and 32 weeks of study treatment. Change at Week 32 used a separate repeated measures ANCOVA model containing Week 8, 16, 24 and 32 data. Treatment, visit and region were factors in the model, treatment by visit interaction and baseline msDBP a covariate.|Baseline to 32 weeks|The analysis population included participants in the Full Analysis Set, (randomized participants who received at least one dose of study drug) for whom efficacy data was available for this outcome measure.||mmHg||Standard Error|Least Squares Mean
783821|NCT00797862|Primary|Overall Mean Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) Over 8, 16 and 24 Weeks|Systolic Blood Pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and over 8, 16 and 24 weeks of study treatment. The overall mean change in msSBP from baseline was estimated over three time points: Week 8, Week 16, and Week 24. Analysis used a repeated measures Analysis of Covariance (ANCOVA) model with treatment, visit, and region as factors, treatment by visit interaction and baseline msSBP as a covariate.|Baseline, 8 weeks, 16 weeks, and 24 weeks|The analysis population included participants in the Full Analysis Set, (randomized participants who received at least one dose of study drug) for whom efficacy data was available for this outcome measure.||mmHg||Standard Error|Least Squares Mean
783822|NCT00797966|Secondary|Percentage of Participants With CGI-I Response From End of Phase A (Week 8 Visit).|CGI-I response is defined as CGI-I of 1 [very much improved] or 2 [much improved].|Week 9, 10, 11, 12, 13 and 14.|ITT dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||percentage of participants|||Number
783823|NCT00797966|Secondary|Percentage of Participants With MADRS Remission From End of Phase A (Week 8 Visit).|A MADRS remission was defined as MADRS Total Score </= 10 and >/= 50% reduction in MADRS Total Score from end of Phase A (Week 8 visit).|Week 8 to each of Week 9, 10, 11, 12, 13 and 14.|ITT dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||Percentage of participants|||Number
783824|NCT00797966|Secondary|Percentage of Participants With MADRS Response From End of Phase A (Week 8 Visit).|A MADRS response was defined as >/= 50% reduction in MADRS Total Score from end of Phase A (Week 8 visit).|Week 8 to each of Week 9, 10, 11, 12, 13 and 14.|ITT dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||Percentage of participants|||Number
783825|NCT00797966|Secondary|Clinical Global Impression-Improvement Scale (CGI-I) Score at Each Study Week Visit in Phase B.|CGI-I items are: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse. The score of 0 (= not assessed) will be set to missing. The CGI-I is therefore a 7-point scale from 1 through 7. CGI-I was assessed at each visit in Phase B, and improvement is judged with respect to the participant's condition at baseline. CGI-I was also assessed at each visit in Phase B, but in that phase improvement is judged with respect to the partcipant's condition at the end of Phase A.|Week 8 to each of Week 9, 10, 11, 12, 13 and 14.|ITT dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||Units on a scale||Standard Deviation|Mean
783826|NCT00797966|Secondary|Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Hamilton Depression Rating Scale (HAM-D17) Score.|The HAM-D17 is utilized as a secondary assessment of a participant's level of depression. The HAM-D (17-Item) consists of 17 items. Eight items are rated on a 0 to 2 scale (items 4, 5, 6, 12, 13, 14, 16 and 17), while nine items (items 1, 2, 3, 7, 8, 9, 10, 11, and 15) are rated on a 0 to 4 scale (twice the weight of the other items). For all of these items, 0 is the “best” rating and the highest score (2 or 4) is the “worst” rating. The possible total scores are from 0 to 52.|Week 8 to Week 14|ITT dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||Units on a scale||Standard Error|Least Squares Mean
783827|NCT00797966|Secondary|Change From End of Phase A (Week 8 Visit) for Every Study Week Visit in Phase B in Inventory of Depressive Symptomatology (Self-Report) (IDS-SR) Total Score.|"The IDS-SR is a 30-item self-report measure used to assess core diagnostic depressive symptoms as well as atypical and melancholic symptom features of major depressive disorders. The IDS-SR consists of 30 items, all rated on a 0 to 3 scale with 0 being the best rating and 3 being the worst rating. The IDS-SR Total Score is the sum of ratings of 28 item scores. The possible IDS-SR Total Score ranges from 0 to 84. The IDS-SR Total Score was un-evaluable if less than 23 of the 28 items are recorded. If the number of items was at least 23 and at most 27, the IDS-SR Total Score will be the mean of the recorded items multiplied by 28 and then rounded to the first decimal place."|Week 8 to each of Week 9, 10, 11, 12, 13 and 14|ITT dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||Units on a scale||Standard Deviation|Mean
783828|NCT00797966|Secondary|Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Mean Q-LES-Q-SF Item 16 Score (Overall Life Satisfaction).|The Q-LES-Q (Short Form) is a self-report measure designed to enable physicians to easily obtain sensitive measures of the degree of enjoyment and satisfaction experienced by participants in various areas of daily functioning. Each item is scored on a five-point scale, with 1= Very Poor; 2=Poor; 3=Fair; 4=Good; 5=Very Good. Lower scores indicating less enjoyment or satisfaction with the activity. According to the scoring system suggested for this questionnaire, item 16 (Overall Life Satisfaction) will yield a separate subscore.|Week 8 to Week 14|ITT dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||Units on a scale||Standard Deviation|Mean
783829|NCT00797966|Secondary|Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Mean Q-LES-Q-SF Item 15 Score (Satisfaction With Medication).|The Q-LES-Q (Short Form) is a self-report measure designed to enable physicians to easily obtain sensitive measures of the degree of enjoyment and satisfaction experienced by participants in various areas of daily functioning. Each item is scored on a five-point scale, with 1= Very Poor; 2=Poor; 3=Fair; 4=Good; 5=Very Good. Lower scores indicating less enjoyment or satisfaction with the activity. According to the scoring system suggested for this questionnaire, item 15 (Satisfaction with Medication) will yield a separate subscore.|Week 8 to Week 14|ITT dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||Units on a scale||Standard Deviation|Mean
783830|NCT00797966|Secondary|Change From End of Phase A (Week 8 Visit) in Mean CGI-S Score for Every Study Week Visit in Phase B Other Than the Week 14 Visit.|CGI-S items are: 0 = not assessed, 1 = normal, not at all ill, 2 = borderline mentally ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill patients. The score 0 (= not assessed) was set to missing. The CGI-S was therefore a 7-point scale from 1 through 7. CGI-S was assessed at screening, baseline and each subsequent visit from Week 1 through Week 14.|Week 8 to each of Week 9, 10, 11, 12 and 13.|ITT dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||Units on a scale||Standard Deviation|Mean
783831|NCT00797966|Secondary|Change From End of Phase A (Week 8 Visit) in MADRS Total Score for Every Study Week Visit in Phase B Other Than the Week 14 Visit.|The MADRS is utilized as the primary efficacy assessment of a patient’s level of depression. The MADRS consists of 10 items, all rated on a 0 to 6 scale with 0 being the “best” rating and 6 being the “worst” rating. The MADRS Total Score is the sum of ratings for all 10 items. The possible Total scores are from 0 to 60. The MADRS Total Score was unevaluable if less than 8 of the 10 items are recorded. If 8 or 9 of the 10 items were recorded, the MADRS Total Score was the mean of the recorded items multiplied by 10 and then rounded to the first decimal place.|Week 8 to each of Week 9, 10, 11, 12 and 13.|ITT dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||Units on a scale||Standard Deviation|Mean
783832|NCT00797966|Secondary|Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Sheehan Disability Scale (SDS) Mean Score (the Mean of 3 Individual Item Scores).|The Sheehan Disability Scale (SDS) is a self-rated instrument used to measure the effect of the participant's symptoms on work/school, social life, and family/home responsibilities. For each of the three items, scores range from 0 through 10. The number most representative of how much each area was disrupted by symptoms is marked along the line from 0 = not at all, to 10 = extremely. For the work/school item, no response was to be entered if the participant did not work or go to school for reasons unrelated to the disorder and a response therefore not being applicable. The Mean SDS Score will be calculated over the three item scores. All three item scores need to be available with the exception of the work/school item score when this item is not applicable.|Week 8 to Week 14|ITT dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||Units on a scale||Standard Error|Least Squares Mean
783833|NCT00797966|Secondary|Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Mean Quality of Life, Enjoyment, and Satisfaction Questionnaire - Short Form (QLES-Q-SF) Subscale Score - the Overall General Subscore (Sum of First 14 Items).|The Q-LES-Q is a self-report measure to enable physicians to obtain sensitive measures of the degree of enjoyment and satisfaction experienced by participants in various areas of daily functioning. Each item is scored on a five-point scale, with 1= Very Poor; 2=Poor; 3=Fair; 4=Good; 5=Very Good. Lower scores indicating less enjoyment or satisfaction with the activity. The Overall-General Subscore will be defined by summing the scores on all 14 items and expressing it as the percent of the maximum possible score. When expressing the total score as a percentage, if items are left blank the range will be modified to reflect the number of items scored. Raw score is sum of non-missing ratings from items 1 to 14. Minimum score is number of non-missing items. Maximum score is 5*(minimum score). Range is maximum score minus minimum score. Total score is 100*(Raw score minus minimum score)/ Range, rounded to nearest integer.|Week 8 to Week 14|ITT dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||Percentage of maximum possible score||Standard Error|Least Squares Mean
783834|NCT00797966|Secondary|Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Mean Clinical Global Impression - Severity of Illness Scale (CGI-S) Score.|CGI-S items are: 0 = not assessed, 1 = normal, not at all ill, 2 = borderline mentally ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill patients. The score 0 (= not assessed) was set to missing. The CGI-S was therefore a 7-point scale from 1 through 7. CGI-S was assessed at screening, baseline and each subsequent visit from Week 1 through Week 14.|Week 8 to Week 14|ITT dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||Units on a scale||Standard Error|Least Squares Mean
783835|NCT00797966|Primary|Change From the End of Phase A (Week 8 Visit) to the End of Phase B (Week 14 Visit) in Montgomery Asberg Depression Rating Scale (MADRS) Total Score.|The MADRS is utilized as the primary efficacy assessment of a participant's level of depression. The MADRS consists of 10 items, all rated on a 0 to 6 scale with 0 being the “best” rating and 6 being the “worst” rating. The MADRS Total Score is the sum of ratings for all 10 items. The possible Total scores are from 0 to 60. The MADRS Total Score was unevaluable if less than 8 of the 10 items are recorded. If 8 or 9 of the 10 items were recorded, the MADRS Total Score was the mean of the recorded items multiplied by 10 and then rounded to the first decimal place.|Week 8 to Week 14|Intent-to-Treat (ITT) dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The Last Observation Carried Forward (LOCF) method was used to impute missing data.||Units on a scale||Standard Error|Least Squares Mean
783836|NCT00798018|Primary|Visual Analogue Scale(0-100mm) by the Subject.|visual analogue scale (VAS) was used to evaluate the post-intubation sore throat. The VAS was a well-recongnized standard tool for rating of pain. The VAS measures exactly 100 mm. 0 means no pain and 100 means the worst pain that one can image. Patient marks a point on the line that matches the amount of pain he or she feels.|6 hours, 12 hours, 24 hours, 48 hours after extubation|||mm||Standard Deviation|Mean
783837|NCT00814138|Secondary|MG Composite Change Over 12 Months|This scale is composed of components of the QMG, MG-ADL and the MMT. These components have been shown to be the most responsive in previous clinical trials. Each item in the QMG, MG-ADL and the MMT was weighed (Rasch analysis performed) and then assigned a score. Score would range from 0 (no effects from the myasthenia gravis) to a score of 50. A participant with a score of 50 wwould be in the hospital on a ventilator.|Change from Baseline to Month 12|||units on a scale||95% Confidence Interval|Mean
783839|NCT00814138|Secondary|MGQOL 12 Month Change|This test is a 15 item patient-reported scale indicating how myasthenia gravis affects the quality of life. Each item is graded as how true each statement has been over the past 7 days. The scale is 0=Not at all, 1= a little bit, 2= somewhat, 3= quite a bit and 4= very much. The numbers are then added to produce a total score. The MGQOL score would range from 0 (no MG symptoms that affected their quality of life) to a score of 60 (MG symptoms affected they quality of life very much).|Change from Baseline to Month 12|||units on a scale||95% Confidence Interval|Mean
783840|NCT00814138|Secondary|Manual Muscle Testing 12 Month Change|This measurement was developed to measure the strength of muscle groups in the face, neck, arms and legs. Measurement is made by grading the amount of weakness. Participants are graded as having normal, mild (25%) weakness, moderate (50%) weakness or severe (75%) weakness and 4 = paralyzed/unable to do. Normal would receive a score of 0, mild would receive a score of 1, moderate would receive a score of 2, severe would receive a score of 3 and unable to perform would receive a score of 4. Range would be from 0 (no weakness) to 76 (complete paralysis).|Change from Baseline to Month 12|||units on a scale||95% Confidence Interval|Mean
783841|NCT00814138|Secondary|Quantitative Myasthenia Gravis (QMG) Score|The QMG is a 13 item ordinal scale which measures ocular, bulbar, extremity fatigue and strength, along with respiratory function. The scale is from 0 - 3 for each item, with 0 meaning normal and 3 is severe. Total score can range from 0 to 39.|Change from Baseline to Month 12|||units on a scale||95% Confidence Interval|Mean
783842|NCT00814138|Secondary|Average Prednisone Daily Dose (mg/Day)|Participants were asked to fill out the amount of prednisone they took every day on a paper diary.|Total length of time daily dose information was collected, i.e. 9 months.|||mg/day||95% Confidence Interval|Mean
783843|NCT00814138|Primary|Total Prednisone Dose Area Under the Curve|The primary outcome measure was the nine-month prednisone area under the dose-time curve (AUDTC, months 4-12). The AUDTC was chosen because it accounted for changes in the prednisone dose that could occur frequently during a month.|9 months|Myasthenia Gravis patients aged 18 and older that were acetylcholine antibody positive with a myasthenia gravis foundation score of Grade II, III or IV.||mg*Months||95% Confidence Interval|Number
783844|NCT00814164|Secondary|A Preliminary Relationship Between Treatment Outcome and Biologic Parameters||4 years|Due to the study's early termination and sponsor's withdrawal of support, data were not collected for this assessment.|||||
783845|NCT00814164|Secondary|Difference in Disease-free and Overall Survival Based on Clofarabine Triphosphate Levels||4 years|Due to the study's early termination and sponsor's withdrawal of support, data were not collected for this assessment.|||||
783846|NCT00814164|Secondary|Difference in Disease-free and Overall Survival According to Multi-drug Resistance Protein Expression||4 years|Due to the study's early termination and sponsor's withdrawal of support, data were not collected for this assessment.|||||
783847|NCT00814164|Secondary|Difference in Disease-free and Overall Survival According to p53R2 Protein Sizes||4 years|Due to the study's early termination and sponsor's withdrawal of support, data were not collected for this assessment.|||||
783848|NCT00814164|Secondary|Differences in Disease-free and Overall Survival Between Patients Whose Cells do or do Not Demonstrate Apoptosis Following Clofarabine and Daunorubicin Hydrochloride Therapy||4 years|Due to the study's early termination and sponsor's withdrawal of support, data were not collected for this assessment.|||||
783849|NCT00814164|Secondary|Overall Survival|Overall survival was defined as time from date of treatment initiation until date of death due to any cause.|4 years|All treated and eligible patients||months||95% Confidence Interval|Median
783850|NCT00814164|Secondary|Disease-free Survival|Disease-free survival was defined as time from first objective documentation of CR or CRp until the date of first objective documentation of disease relapse or death due to any cause, whichever occurs first.|5 years|All treated and eligible patients who had first objective documentation of CR or CRp.||months||95% Confidence Interval|Median
783851|NCT00814164|Primary|Complete Remission (CR)|Complete Response/Remission (CR) was defined on morphologic criteria at a single response assessment as follows: A bone marrow aspirate or biopsy of < 5% blasts, with evidence of normal hematopoiesis; Absence of Auer rods in the blast that are present; Absence of extramedullary disease [imaging required only if obtained pretreatment for known site(s) of disease]; If applicable and available, absence of a unique phenotype determined at the pretreatment specimen, as assessed by immunophenotyping; Recovery of peripheral counts (platelets ≥100x109/L, and ANC ≥1.0x109/L). Peripheral count recovery must be documented no earlier than 7 days prior to, and no later than 14 days following, the bone marrow assessment that provides evidence of the CR. Complete Response/Remission without platelet recovery (CRp) was defined as all criteria for CR except for thrombocytopenia (platelet count ≥75x109/L).|2 years|All treated and eligible patients||percentage of participant||95% Confidence Interval|Number
783852|NCT00814177|Primary|Number of Patients With Prothrombin Time Results Within the Therapeutic Range After 2 Weeks|"The number of patients with follow-up INRs within the therapeutic range was compared for patients with a single dose skipped/reduced/added versus patients with no change of dose."|2 weeks|||participants|||Number
783853|NCT00814255|Secondary|Percent Change in or Time to Doubling of Serum Creatinine||Baseline and 6 months|No data were collected.|||||
783854|NCT00814255|Secondary|Percent Change in Proteinuria||Baseline and 6 months|No data were collected.|||||
783855|NCT00814255|Secondary|Number of Participants With Adverse Events||Up to 7 months|||participants|||Number
783856|NCT00814255|Secondary|Patient Satisfaction Score Using the Treatment Satisfaction Questionnaire for Medication (TSQM Questionnaire)|Patient Satisfaction Score Using the Treatment Satisfaction Questionnaire for Medication (TSQM Questionnaire)|Baseline and 6 months|No data were collected.|||||
783857|NCT00814255|Primary|Number of Participants With a Reduction in Proteinuria at 6 Months by > 50% of the Value at Screening AND Stable GFR Defined as Greater Than 75 ml/Min/1.73m2 in Those With an Initial Value Above 90 OR Within 25% of Baseline for Remaining Patients|Number of participants with a reduction in proteinuria at 6 months by > 50% of the value at screening AND stable GFR defined as greater than 75 ml/min/1.73m2 in those with an initial value above 90 OR within 25% of baseline for remaining patients.|baseline and 6 months|One participant was assigned to the rosiglitazone arm before the drug was replaced with the galactose arm. This participant was not included in the analysis.||participants|||Number
783906|NCT00814320|Secondary|Number of Participants Who Developed Neutralizing Antibodies to Recombinant Human Hyaluronidase (rHuPH20)||Throughout the study period (17 months)|Safety Analysis Data Set||Number of participants|||Number
783858|NCT00814307|Secondary|Work Limitations Questionnaire (WLQ) Score at Month 6|WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0[no loss] to 100[complete loss of work]).|Month 6|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given parameter for each group respectively.||units on a scale||Standard Deviation|Mean
783859|NCT00814307|Secondary|Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3|WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0[no loss] to 100[complete loss of work]).|Baseline, Month 3|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.||units on a scale||Standard Deviation|Mean
783860|NCT00814307|Other Pre-specified|Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Global Assessment of Arthritis|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm Visual Analog Scale where 0 = very well and 100 = very poorly."|2 weeks|FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||days|||Number
783861|NCT00814307|Other Pre-specified|Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Assessment of Arthritis Pain|Participants assessed the severity of their arthritis pain using a 100 millimeter (mm) visual analog scale (VAS). The scale ranged from 0 (no pain) to 100 (most severe pain), measurement on a scale corresponds to the magnitude of their pain.|2 weeks|FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||days|||Number
783862|NCT00814307|Secondary|Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 6|Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance.|Month 6|FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
783863|NCT00814307|Secondary|Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline and Month 3|Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance.|Baseline, Month 3|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.||units on a scale||Standard Deviation|Mean
783864|NCT00814307|Secondary|Number of Hours Per Days as Assessed Using RA-HCRU at Month 6|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported.|Month 6|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.||hours per day||Standard Deviation|Mean
783865|NCT00814307|Secondary|Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported.|Baseline, Month 3|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.||hours per day||Standard Deviation|Mean
783866|NCT00814307|Secondary|Number of Days as Assessed Using RA-HCRU at Month 6|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains.Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.|Month 6|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.||days||Standard Deviation|Mean
783867|NCT00814307|Secondary|Number of Days as Assessed Using RA-HCRU at Baseline and Month 3|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains.Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.|Baseline, Month 3|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.||days||Standard Deviation|Mean
783868|NCT00814307|Secondary|Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.|Month 6|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.||events||Standard Deviation|Mean
783869|NCT00814307|Secondary|Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.|Baseline, Month 3|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.||events||Standard Deviation|Mean
783870|NCT00814307|Secondary|Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6|Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost:visit to doctor,non-medical practitioner,nursing home,hospital,surgery,emergency room(ER) treatment,diagnostic tests, over-night stay,home healthcare services, aids/devices used. Indirect costs associated with functional disability:employment status,willingness to work,work disability due to RA,sick leave,part time work,ability to perform chores,chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale;higher score=higher medical cost.|Month 6|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.||units on a scale||Standard Deviation|Mean
783871|NCT00814307|Secondary|Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3|Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost:visit to doctor,non-medical practitioner,nursing home,hospital,surgery,emergency room(ER) treatment,diagnostic tests, over-night stay,home healthcare services, aids/devices used. Indirect costs associated with functional disability:employment status,willingness to work,work disability due to RA,sick leave,part time work,ability to perform chores,chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale;higher score=higher medical cost.|Baseline, Month 3|FAS population. Participants with at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint were included. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.||units on a scale||Standard Deviation|Mean
783872|NCT00814307|Secondary|Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Month 6|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Month 6|FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
783873|NCT00814307|Secondary|Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Baseline and Month 3|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Baseline, Month 3|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.||units on a scale||Standard Deviation|Mean
783874|NCT00814307|Secondary|Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 6|FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.|Month 6|FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
783875|NCT00814307|Secondary|Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline and Month 3|FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.|Baseline, Month 3|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.||units on a scale||Standard Deviation|Mean
783876|NCT00814307|Secondary|Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6|MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported.|Month 6|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||participants|||Number
784588|NCT00824772|Secondary|Postoperative Cumulative Fentanyl Consumption||48hr after surgery|||mcg||Standard Deviation|Mean
784589|NCT00824772|Primary|Postoperative Cumulative Fentanyl Consumption||24 hr after surgery|||mcg||Standard Deviation|Mean
783877|NCT00814307|Secondary|Medical Outcome Study Sleep Scale (MOS-SS) at Month 6|Participant-rated 12 item questionnaire assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no). 9 item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score minus lowest possible score divided by possible raw score range*100);total score range:0-100,higher score=more intensity of attribute.|Month 6|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
783878|NCT00814307|Secondary|Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Month 3|MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported.|Baseline, Month 3|FAS population. 'n'=participants evaluable at given time point for each group respectively.||participants|||Number
783879|NCT00814307|Secondary|Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3|Participant-rated 12 item questionnaire assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no). 9 item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score minus lowest possible score divided by possible raw score range*100);total score range:0-100,higher score=more intensity of attribute.|Baseline, Month 3|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.||units on a scale||Standard Deviation|Mean
783880|NCT00814307|Secondary|36-Item Short-Form Health Survey (SF-36) at Month 6|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; Physical Component Score and Mental Component Score. Total score range for the summary scores = 0- 100, where higher score represents higher level of functioning.|Month 6|FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
783881|NCT00814307|Secondary|36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; Physical Component Score and Mental Component Score. Total score range for the summary scores = 0- 100, where higher score represents higher level of functioning.|Baseline, Month 3|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.||units on a scale||Standard Deviation|Mean
783882|NCT00814307|Secondary|Physician Global Assessment (PGA) of Arthritis Pain at Month 4, 5 and 6|Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.|Month 4, 5, 6|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.||mm||Standard Deviation|Mean
783883|NCT00814307|Secondary|Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3|Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.|Baseline, Week 2, Month 1, 2, 3|FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'n'=participants evaluable at given time point for each group respectively.||mm||Standard Deviation|Mean
783884|NCT00814307|Secondary|Patient Global Assessment (PtGA) of Arthritis Pain at Month 4, 5 and 6|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm Visual Analog Scale where 0 = very well and 100 = very poorly."|Month 4, 5, 6|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.||mm||Standard Deviation|Mean
783885|NCT00814307|Secondary|Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm Visual Analog Scale where 0 = very well and 100 = very poorly."|Baseline, Week 2, Month 1, 2, 3|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.||mm||Standard Deviation|Mean
783886|NCT00814307|Secondary|Patient Assessment of Arthritis Pain at Month 4, 5 and 6|Participants assessed the severity of their arthritis pain using a 100 mm visual analog scale (VAS). The scale ranged from 0 (no pain) to 100 (most severe pain), measurement on a scale corresponds to the magnitude of their pain.|Month 4, 5, 6|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.||mm||Standard Deviation|Mean
783907|NCT00814320|Secondary|Median Rate of AEs Temporally Associated or Related to Study Drug Per Infusion|"Temporally associated defined as during infusion or within 72 hours of completion of infusion.
Related defined as determined by investigator to be at least possibly related to study drug (immune globulin intravenous [IGIV], 10% or recombinant human hyaluronidase [rHuPH20]).
Expressed as a percentage."|Throughout the study period (17 months)|Safety Analysis Data Set||Percentage of AE|Participants|95% Confidence Interval|Median
783887|NCT00814307|Secondary|Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3|Participants assessed the severity of their arthritis pain using a 100 millimeter (mm) visual analog scale (VAS). The scale ranged from 0 (no pain) to 100 (most severe pain), measurement on a scale corresponds to the magnitude of their pain.|Baseline, Week 2, Month 1, 2, 3|FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'n'=participants evaluable at given time point for each group respectively.||mm||Standard Deviation|Mean
783888|NCT00814307|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 4, 5 and 6|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 functional categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3, 0=least functional difficulty and 3=extreme functional difficulty.|Month 4, 5, 6|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.||units on a scale||Standard Deviation|Mean
783889|NCT00814307|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2 and 3|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 functional categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3, 0=least functional difficulty and 3=extreme functional difficulty.|Baseline, Week 2, Month 1, 2, 3|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.||units on a scale||Standard Deviation|Mean
783890|NCT00814307|Secondary|Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 4, 5 and 6|DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Month 4, 5, 6|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.||units on a scale||Standard Deviation|Mean
783891|NCT00814307|Secondary|Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1, 2 and 3|DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (milligram per liter [mg/L]). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Baseline, Week 2, Month 1, 2, 3|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.||units on a scale||Standard Deviation|Mean
783892|NCT00814307|Secondary|Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 6|DAS28-4 (ESR) calculated from swollen joint count (SJC) and tender/painful joint count (TJC) using 28 joint count, erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) less than or equal to (=<) 3.2 implied low disease activity, greater than (>) 3.2 to 5.1 implied moderate to high disease activity and less than (<) 2.6=remission.|Month 6|FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
783893|NCT00814307|Secondary|Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline and Month 3|DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PtGA of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Baseline, Month 3|FAS population. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.||units on a scale||Standard Deviation|Mean
783894|NCT00814307|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 4, 5 and 6|ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.|Month 4, 5, 6|FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||percentage of participants|||Number
783895|NCT00814307|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 2, Month 1, 2 and 3|ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.|Week 2, Month 1, 2, 3|FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||percentage of participants|||Number
783896|NCT00814307|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 4, 5 and 6|ACR50 response: greater than or equal to >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.|Month 4, 5, 6|FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||percentage of participants|||Number
783897|NCT00814307|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 2, Month 1, 2 and 3|ACR50 response: greater than or equal to >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.|Week 2, Month 1, 2, 3|FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||percentage of participants|||Number
783898|NCT00814307|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 4, 5 and 6|ACR20 response: >= 20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Month 4, 5, 6|FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||percentage of participants|||Number
783899|NCT00814307|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 2, Month 1 and 2|ACR20 response: >= 20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 2, Month 1, 2|FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||percentage of participants|||Number
783900|NCT00814307|Primary|Percentage of Participant With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 3|DAS28-4 (ESR) calculated from swollen joint count (SJC) and tender/painful joint count (TJC) using 28 joint count, erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) less than or equal to (=<) 3.2 implied low disease activity, greater than (>) 3.2 to 5.1 implied moderate to high disease activity and less than (<) 2.6=remission.|Month 3|FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||percentage of participants|||Number
783901|NCT00814307|Primary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 functional categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3, 0=least functional difficulty and 3=extreme functional difficulty.|Baseline, Month 3|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
783902|NCT00814307|Primary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 3|ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Month 3|Full Analysis Set (FAS): all randomized participants who received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. ‘N’ (number of participants analyzed)=participants evaluable for this measure.||percentage of participants|||Number
783903|NCT00814320|Secondary|Percentage of Participants Who Experienced a Hemoglobin Drop of >2.0 g/dL, With Evidence of Hemolysis on Further Analysis|Further analysis for incidences of potential hemolysis included direct Coombs’ test, free hemoglobin, serum haptoglobin, LDH, urine hemosiderin and microscopic urinalysis|Throughout the study period (17 months)|||Percentage of participants|||Number
783904|NCT00814320|Secondary|Number of Participants Who Experienced a Hemoglobin Drop of >2.0 g/dL, With Evidence of Hemolysis on Further Analysis|Further analysis for incidences of potential hemolysis included direct Coombs’ test, free hemoglobin, serum haptoglobin, LDH, urine hemosiderin and microscopic urinalysis|Throughout the study period (17 months)|||Number of participants|||Number
783905|NCT00814320|Secondary|Percentage of Participants Who Developed Neutralizing Antibodies to Recombinant Human Hyaluronidase (rHuPH20)||Throughout the study period (17 months)|Safety Analysis Data Set||Percentage of participants|||Number
783908|NCT00814320|Secondary|Percentage of Infusions Tolerated With IV and SC Administration at Dose Used in Study Epoch 2 (SC/rHuPH20 Treatment)|"Epoch 2: subcutaneous (SC) administration of immune globulin intravenous (IGIV), 10% with recombinant human hyaluronidase (rHuPH20) after ramp-up.
Dose used in Epoch 2 (after ramp-up) was 108% of dose used in intravenous (IV) administration of IGIV, 10%.
The percentage of affected infusions is calculated per subject and then summarized by the median of all subjects analysed."|Throughout the study period (17 months)|Safety Analysis Data Set||Percentage of infusions|Participants|95% Confidence Interval|Median
783909|NCT00814320|Secondary|Percentage of Infusions Associated With ≥1 AE Related to Either or Both Study Drugs|"Percentage of Infusions Associated With ≥1 AE Related to immune globulin intravenous (IGIV), 10%, [administered via intravenous (IV) or subcutaneous (SC) route], recombinant human hyaluronidase (rHuPH20) or both.
The percentage of affected infusions is calculated per subject and then summarized by the median of all subjects analysed."|Throughout the study period (17 months)|Safety Analysis Data Set||Percentage of infusions|Participants|95% Confidence Interval|Median
783910|NCT00814320|Secondary|Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z)|"Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used:
Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe
Preferred terms abbreviated:
Resp.-Respiratory WBC - White blood cells"|Throughout the study period (17 months)|Safety Analysis Data Set||Number of AEs per participant|||Number
783911|NCT00814320|Secondary|Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M)|"Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used:
Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe"|Throughout the study period (17 months)|Safety Analysis Data Set||Number of AEs per participant|||Number
783912|NCT00814320|Secondary|Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F)|"Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used:
Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe
Preferred terms abbreviated:
ADHD-Attention Deficit/Hyperactivity Disorder BP-Blood Pressure COPD- Chronic Obstructive Pulmonary Disease"|Throughout the study period (17 months)|Safety Analysis Data Set||Number of AEs per participant|||Number
783913|NCT00814320|Secondary|Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z)|"Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used:
Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); ; RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe
Preferred terms abbreviated:
Resp.-Respiratory WBC - White blood cells"|Throughout the study period (17 months)|Safety Analysis Data Set||Number of AEs per infusion|Participants||Number
783914|NCT00814320|Secondary|Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M)|"Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used:
Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe"|Throughout the study period (17 months)|Safety Analysis Data Set||Number of AEs per infusion|Participants||Number
783915|NCT00814320|Secondary|Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F)|"Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used:
Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe
Preferred terms abbreviated:
ADHD-Attention Deficit/Hyperactivity Disorder BP-Blood Pressure COPD- Chronic Obstructive Pulmonary Disease"|Throughout the study period (17 months)|Safety Analysis Data Set||Number of AEs per infusion|Participants||Number
783916|NCT00814320|Secondary|Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z)|"Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used:
Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe
Preferred terms abbreviated:
Resp.-Respiratory WBC - White blood cells"|Throughout the study period (17 months)|Safety Analysis Data Set||Number of AEs|||Number
783917|NCT00814320|Secondary|Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M)|"Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used:
Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe"|Throughout the study period (17 months)|Safety Analysis Data Set||Number of AEs|||Number
783930|NCT00814320|Secondary|Percentage of Participants Reporting ≥1 Temporally Associated Moderate or Severe AEs|"Percentage of participants reporting at least 1 Moderate or Severe AE (including and excluding infections) during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up (during infusion) or within 72 hours of completion of infusion (temporally associated)"|During infusion or within 72 hours of completion of infusion|Safety Analysis Data Set||Percentage of participants|||Number
783918|NCT00814320|Secondary|Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F)|"Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used:
Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe
Preferred terms abbreviated:
ADHD-Attention Deficit/Hyperactivity Disorder BP-Blood Pressure COPD- Chronic Obstructive Pulmonary Disease"|Throughout the study period (17 months)|Safety Analysis Data Set||Number of AEs|||Number
783919|NCT00814320|Secondary|Frequency of Dose Corrections (If IgG Trough Levels <4.5 g/L) for Each Study Epoch (IV and SC/rHuPH20 Treatment)|Frequency of dose corrections based on immune globulin G (IgG) trough levels <4.5 g/L IgG, if any, for intravenous (IV) (Epoch 1) and subcutaneous with recombinant human hyaluronidase (SC/rHuPH20) after ramp-up (Epoch 2) administration of immune globulin intravenous (IGIV), 10% Defined/calculated as the number of participants requiring dose adjustments divided by the number of participants, for each respective data set.|Throughout the study period (17 months)|Safety Analysis Data Set||Percentage of participants|||Number
783920|NCT00814320|Secondary|Rate of AEs Determined to be Related to the Study Drug by the Investigator Per Infusion|Rate of related AEs defined as the total number of AEs determined by the investigator to be related to the study drug (immune globulin intravenous [IGIV], 10% or recombinant human hyaluronidase [rHuPH20]), that occur at any time during the study divided by the total number of infusions|Throughout the study period (17 months)|Safety Analysis Data Set||Number of AEs per infusion|Participants|95% Confidence Interval|Median
783921|NCT00814320|Secondary|Rate of AEs Determined to be Related to the Study Drug by the Investigator Per Participant|Rate of related AEs defined as the total number of AEs determined by the investigator to be related to the study drug (immune globulin intravenous [IGIV], 10% or recombinant human hyaluronidase [rHuPH20]), that occur at any time during the study divided by the total number of participants|Throughout the study period (17 months)|Safety Analysis Data Set||Number of AEs per participant||95% Confidence Interval|Median
783922|NCT00814320|Secondary|Percentage of Participants With ≥1 Local AE At Any Time During the Study|Percentage of participants With ≥1 local AE (including and excluding infections) after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up at any time during the study|During infusion or within 72 hours of completion of infusion|Safety Analysis Data Set||Percentage of participants|||Number
783923|NCT00814320|Secondary|Percentage of Participants With ≥1 Local AE During Infusion or Within 72 Hours of Completion of Infusion|Percentage of participants With ≥1 local AE (including and excluding Infections) during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up (during infusion) or within 72 hours of completion of infusion|During infusion or within 72 hours of completion of infusion|Safety Analysis Data Set||Percentage of participants|||Number
783924|NCT00814320|Secondary|Percentage of Infusions Associated With ≥1 Local AE At Any Time During the Study|Percentage of intravenous (IV) and subcutaneous (SC) infusions with recombinant human hyaluronidase (rHuPH20) after ramp-up of immune globulin intravenous (IGIV), 10% associated with ≥1 local AE (including and excluding infections) at any time during the study|At any time during the study|Safety Analysis Data Set||Percentage of infusions|Participants|95% Confidence Interval|Median
783925|NCT00814320|Secondary|Percentage of Infusions Associated With ≥1 Local AE (Including and Excluding Infections) During Infusion or Within 72 Hours of Completion of Infusion|Percentage of IV and SC (with recombinant human hyaluronidase [rHuPH20]) infusions associated with ≥1 local AE (including and excluding infections) during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with rHuPH20 after ramp-up (during infusion) or within 72 hours of completion of infusion|During infusion or within 72 hours of completion of infusion|Safety Analysis Data Set||Percentage of infusions|Participants|95% Confidence Interval|Median
783926|NCT00814320|Secondary|Percentage of Participants With ≥1 Systemic AE (Including and Excluding Infections) During Infusion or Within 72 Hours of Completion of Infusion|Percentage of participants with ≥1 systemic AE (including and excluding Infections) during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up (during infusion) or within 72 hours of completion of infusion|During infusion or within 72 hours of completion of infusion|Participants exposed to either or both study drugs||Percentage of participants|||Number
783927|NCT00814320|Secondary|Percentage of Infusions Associated With ≥1 Systemic AE During Infusion or Within 72 Hours of Completion of Infusion|Percentage of intravenous (IV) and subcutaneous (SC) infusions associated with ≥1 systemic AE (including and excluding infections) during administration of immune globulin intravenous (IGIV), 10% given via IV or SC route with recombinant human hyaluronidase (rHuPH20) after ramp-up (during infusion) or within 72 hours of completion of infusion|During infusion or within 72 hours of completion of infusion|Safety Analysis Data Set||Percentage of infusions|Participants|95% Confidence Interval|Median
783928|NCT00814320|Secondary|Percentage of SC Doses of IGIV, 10% and rHuPH20 Tolerated at 1 Infusion Site|"Percentage of subcutaneous (SC) doses of immune globulin intravenous (IGIV), 10% and recombinant human hyaluronidase (rHuPH20) tolerated at 1 infusion site.
An infusion was deemed as tolerated if there were no serious adverse drug reactions (ADRs), no non-serious moderate or severe local ADRs that prevented completion of the infusion, and no non-serious moderate or severe systemic ADRs during or within 60 minutes of completion of the infusion."|During infusion or within 60 minutes of completion of the infusion|Safety Analysis Data Set||Percentage of infusions||95% Confidence Interval|Median
783929|NCT00814320|Secondary|Percentage of Infusions Resulting in ≥1 Temporally Associated Moderate or Severe AEs Within 72 Hours of Completion of Infusion|"Percentage of infusions resulting in at least 1 moderate or severe AE (including and excluding infections) during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up (during infusion) or within 72 hours of completion of infusion (temporally associated)"|During infusion or within 72 hours of completion of infusion|Safety Analysis Data Set||Percentage of infusions|Participants|95% Confidence Interval|Median
783931|NCT00814320|Secondary|Percentage of Infusions Resulting in ≥1 Temporally Associated AEs|"Percentage of infusions resulting in at least 1 AE (including and excluding infections) during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up (during infusion) or within 72 hours of completion of infusion (temporally associated)"|During infusion or within 72 hours of completion of infusion|Safety Analysis Data Set||Percentage of infusions|Participants||Number
783932|NCT00814320|Secondary|Percentage of Participants Reporting ≥1 Temporally Associated AEs|"Percentage of participants reporting at least 1 AE (including and excluding infections) during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up (during infusion) or within 72 hours of completion of infusion (temporally associated)"|During infusion or within 72 hours of completion of infusion|Safety Analysis Data Set||Percentage of participants|||Number
783933|NCT00814320|Secondary|Rate of Temporally Associated AEs Per Infusion|Rate of all AEs (including and excluding infections) per infusion that began during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up (during infusion) or within 72 hours of completion of an infusion (“temporally associated”)|During infusion or within 72 hours of completion of infusion|Safety Analysis Data Set (SADS)||Number of AEs per infusion|Participants|95% Confidence Interval|Median
783934|NCT00814320|Secondary|Percentage of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Interrupted or Stopped for Tolerability Concerns or for Adverse Events (AEs)|"Percentage of infusions for which the infusion rate was reduced and/or the infusion interrupted or stopped during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up for tolerability concerns or for adverse events (AEs).
IV administration of IGIV, 10%: 365 infusions; SC administration of IGIV, 10% with rHuPH20: 1129 infusions"|Throughout the study period (17 months)|Safety Analysis Data Set||Percentage of infusions|Participants||Number
783935|NCT00814320|Secondary|Percentage of Participants for Which the Infusion Rate Was Reduced and/or the Infusion Interrupted or Stopped for Tolerability Concerns or for Adverse Events (AEs)|"Percentage of participants for which the infusion rate was reduced and/or the infusion interrupted or stopped during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up for tolerability concerns or for adverse events (AEs).
An infusion was deemed as tolerated if there are no serious Adverse Drug Reactions (ADR), no non-serious moderate or severe local ADRs that prevent completion of the infusion and no non-serious moderate or severe systemic ADRs during infusion or within 60 minutes of completion of the infusion."|Throughout the study period (17 months)|Safety Analysis Data Set||Percentage of participants|||Number
783936|NCT00814320|Secondary|Rate of Days in Hospital|"Monthly rate of days in hospital after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up.
Point estimates and 95% CIs for the monthly rates will be calculated using a Poisson model and the same methodology including allowance for over-dispersion as described for the primary outcome measures.
The lengths of the month will be defined as average length of the month in the Gregorian calendar, namely (365*400+100-3)/(400*12)= 30.436875 days."|Monthly, for up to 17 months|Full Analysis Data Set||Days per month||95% Confidence Interval|Number
783937|NCT00814320|Secondary|Rate of Acute Physician Visits|"Monthly rate of acute physician visits after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up.
Point estimates and 95% CIs for the monthly rates will be calculated using a Poisson model and the same methodology including allowance for over-dispersion as described for the primary outcome measures.
The lengths of the month will be defined as average length of the month in the Gregorian calendar, namely (365*400+100-3)/(400*12)= 30.436875 days."|Monthly, for up to 17 months|Full Analysis Data Set||Visits per month||95% Confidence Interval|Number
783938|NCT00814320|Secondary|Rate of Days on Antibiotics|"Monthly rate of days on antibiotics after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up.
Point estimates and 95% CIs for the monthly rates were calculated using a Poisson model and the same methodology including allowance for over-dispersion as described for the primary outcome measures.
The lengths of the month was defined as average length of the month in the Gregorian calendar, namely (365*400+100-3)/(400*12)= 30.436875 days."|Monthly, for up to 17 months|Full Analysis Data Set||Days on antibiotics per month||95% Confidence Interval|Number
783939|NCT00814320|Secondary|Rate of Days Off School or Work|"Monthly rate of days off school or work after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up.
Point estimates and 95% CIs for the monthly rates were calculated using a Poisson model and the same methodology including allowance for over-dispersion as described for the primary outcome measures.
The lengths of the month were defined as average length of the month in the Gregorian calendar, namely (365*400+100-3)/(400*12)= 30.436875 days."|Monthly, for up to 17 months|Full Analysis Data Set||Days off per month||95% Confidence Interval|Number
783940|NCT00814320|Secondary|Time to Maximum H. Influenzae Antibody Concentration (T-max) for Participants Aged 12 Years and Older|Time to Maximum influenza (haemophilus influenzae) antibody Concentration (T-max) after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:
Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*
*Measurements at Day 28 for the 4-week treatment interval only"||Days||95% Confidence Interval|Median
784097|NCT00822185|Secondary|Vatreptacog Alfa Clot Activity- Apparent Volume of Distribution at Steady State (Vss)||during 1-2 days after drug administration|PK analysis set included all the subjects not violating the protocol in a manner that was judged to affect PK endpoint evaluation. Two (2) subject did not contribute to PK evaluation.||mL/kg||Geometric Coefficient of Variation|Geometric Mean
783941|NCT00814320|Secondary|H. Influenzae Antibody Terminal Half Life (T1/2) for Participants Aged 12 Years and Older|"Terminal half life (T1/2) for influenza (haemophilus influenzae) antibody after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older.
Terminal half life is the time it takes for the plasma concentration or the amount of influenza antibody in the body to be reduced by 50% during the terminal phase."|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:
Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*
*Measurements at Day 28 for the 4-week treatment interval only"||Days||95% Confidence Interval|Median
783942|NCT00814320|Secondary|H. Influenzae Antibody Maximum Plasma Concentration (C_max) for Participants Aged 12 Years and Older|Maximal influenza (haemophilus influenzae) antibody concentration after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:
Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*
*Measurements at Day 28 for the 4-week treatment interval only"||μg/mL||95% Confidence Interval|Median
783943|NCT00814320|Secondary|H. Influenzae Antibody Clearance (CL) for Participants Aged 12 Years and Older|"Influenza (haemophilus influenzae) antibody Clearance after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older.
Clearance (CL) is provided after administration of IGIV,10% given via IV route. Apparent Clearance is provided after administration of IGIV, 10% given via SC route with rHuPH20.
Clearance (CL) and apparent clearance are determined by weight adjusted dose divided by total AUC."|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval];SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:
Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*
*Measurements at Day 28 for the 4-week treatment interval only"||L/kg/day||95% Confidence Interval|Median
783944|NCT00814320|Secondary|H. Influenzae Antibody Area Under the Curve (AUC)/Week for Participants Aged 12 Years and Older|"Influenza (haemophilus influenzae) antibody Area under the Curve (AUC) AUC/week after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older.
The AUC between adjacent infusions was calculated by the trapezoidal rule. Linear interpolation/extrapolation was used to calculate the AUC for the exact duration of the infusion intervals (21 days for 3-week treatment interval or 28 days for 4-week treatment interval)."|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval];SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:
Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*
*Measurements at Day 28 for the 4-week treatment interval only"||μg*days/mL||95% Confidence Interval|Median
783945|NCT00814320|Secondary|H. Influenzae Antibody Minimum Plasma Concentration (C_min) for Participants Aged 12 Years and Older|Minimal influenza (haemophilus influenzae) antibody concentration after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:
Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*
*Measurements at Day 28 for the 4-week treatment interval only"||μg/mL||95% Confidence Interval|Median
783946|NCT00814320|Secondary|Time to Maximum Tetanus Antibody Concentration (T-max) for Participants Aged 12 Years and Older|Time to Maximum tetanus (clostridium tetani toxoid) antibody Concentration (T-max) after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:
Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*
*Measurements at Day 28 for the 4-week treatment interval only"||Days||95% Confidence Interval|Median
783947|NCT00814320|Secondary|Tetanus Antibody Maximum Plasma Concentration (C_max) for Participants Aged 12 Years and Older|Maximum tetanus (clostridium tetani toxoid) antibody concentration after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:
Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*
*Measurements at Day 28 for the 4-week treatment interval only"||IU/mL||95% Confidence Interval|Median
784020|NCT00814580|Secondary|Sleep Quality: Feeling Alert During Daytime Hours? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)|"Over the past 7 days patients reported Feeling alert during daytime hours by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7)."|Baseline and 7 Days|Oxycodone IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).||participants|||Number
783948|NCT00814320|Secondary|Tetanus Antibody Terminal Half Life (T1/2) for Participants Aged 12 Years and Older|"Terminal half life (T1/2) for tetanus (clostridium tetani toxoid) antibody after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older.
Terminal half life is the time it takes for the plasma concentration or the amount of tetanus antibody in the body to be reduced by 50% during the terminal phase"|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:
Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*
*Measurements at Day 28 for the 4-week treatment interval only"||Days||95% Confidence Interval|Median
783949|NCT00814320|Secondary|Tetanus Antibody Clearance (CL) for Participants Aged 12 Years and Older|"Tetanus (clostridium tetani toxoid) antibody Clearance after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older.
Clearance (CL) is provided after administration of IGIV,10% given via IV route. Apparent Clearance is provided after administration of IGIV, 10% given via SC route with rHuPH20.
Clearance (CL) and apparent clearance are determined by weight adjusted dose divided by total AUC."|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval];SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:
Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*
*Measurements at Day 28 for the 4-week treatment interval only"||nL/IU/day||95% Confidence Interval|Median
783950|NCT00814320|Secondary|Tetanus Antibody Area Under the Curve (AUC)/Week for Participants Aged 12 Years and Older|"Tetanus (clostridium tetani toxoid) antibody Area under the Curve (AUC) AUC/week after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older.
The AUC between adjacent infusions was calculated by the trapezoidal rule. Linear interpolation/extrapolation was used to calculate the AUC for the exact duration of the infusion intervals (21 days for 3-week treatment interval or 28 days for 4-week treatment interval)."|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval];SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:
Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*
*Measurements at Day 28 for the 4-week treatment interval only"||IU*days/mL||95% Confidence Interval|Median
783951|NCT00814320|Secondary|Tetanus Antibody Minimum Plasma Concentration (C_min) for Participants Aged 12 Years and Older|Minimal tetanus (clostridium tetani toxoid) antibody concentration after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:
Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*
*Measurements at Day 28 for the 4-week treatment interval only"||IU/mL||95% Confidence Interval|Median
783952|NCT00814320|Secondary|Time to Maximum IgG Concentration (T-max) for Participants Aged 12 Years and Older|Time to Maximum Immunoglobulin (IgG) Concentration (T-max) after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:
Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*
*Measurements at Day 28 for the 4-week treatment interval only"||Days||95% Confidence Interval|Median
783953|NCT00814320|Secondary|IgG Terminal Half Life (T1/2) for Participants Aged 12 Years and Older|"Terminal half life (T1/2) for immunoglobulin (IgG) after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older.
Terminal half life is the time it takes for the plasma concentration or the amount of immunoglobulin in the body to be reduced by 50% during the terminal phase"|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:
Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*
*Measurements at Day 28 for the 4-week treatment interval only"||Days||95% Confidence Interval|Median
783954|NCT00814320|Secondary|IgG Maximum Plasma Concentration (C_max) for Participants Aged 12 Years and Older|Maximum immunoglobulin (IgG) concentration after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:
Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*
*Measurements at Day 28 for the 4-week treatment interval only"||g/L||95% Confidence Interval|Median
784098|NCT00822185|Secondary|Vatreptacog Alfa Clot Activity- Total Clearance (CL)||during 1-2 days after drug administration|PK analysis set included all the subjects not violating the protocol in a manner that was judged to affect PK endpoint evaluation. Two (2) subjects did not contribute to data.||mL/h/kg||Geometric Coefficient of Variation|Geometric Mean
783955|NCT00814320|Secondary|IgG Clearance (CL) for Participants Aged 12 Years and Older|"Immunoglobulin (IgG) Clearance after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older.
Clearance (CL) is provided after administration of IGIV,10% given via IV route. Apparent Clearance is provided after administration of IGIV, 10% given via SC route with rHuPH20.
Clearance and apparent clearance are determined by weight adjusted dose divided by total AUC."|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval];SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:
Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*
*Measurements at Day 28 for the 4-week treatment interval only"||mL/kg/day||95% Confidence Interval|Median
783956|NCT00814320|Secondary|IgG Area Under the Curve (AUC)/Week for Participants Aged 12 Years and Older|"Immunoglobulin (IgG) Area under the Curve (AUC) AUC/week after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older.
The AUC between adjacent infusions was calculated by the trapezoidal rule. Linear interpolation/extrapolation was used to calculate the AUC for the exact duration of the infusion intervals (21 days for 3-week treatment interval or 28 days for 4-week treatment interval)."|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval];SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:
Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*
*Measurements at Day 28 for the 4-week treatment interval only"||g*days/L||95% Confidence Interval|Median
783957|NCT00814320|Secondary|IgG Minimum Plasma Concentration (C_min) for Participants Aged 12 Years and Older|Minimal immunoglobulin (IgG) concentration after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and Older|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:
Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*
*Measurements at Day 28 for the 4-week treatment interval only"||g/L||95% Confidence Interval|Median
783958|NCT00814320|Secondary|Antibody Levels to Hepatitis B|Antibody levels to hepatitis B after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) with recombinant human hyaluronidase (rHuPH20) at end of IV treatment and end of SC treatment with rHuPH20|IV: At baseline; SC/rHuPH20: at baseline then at infusion #1 at ramp-up and at infusions #5, 9, 13 (for 3-week treatment interval) and infusions #4, 7, 10 (for 4-week treatment interval), SC: end of SC treatment and at end of study visit|Participants in the Full Analysis Data Set with available specific antibody test results||mIU/mL||95% Confidence Interval|Median
783959|NCT00814320|Secondary|Antibody Levels to Measles|Antibody levels to measles after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) at end of IV treatment and end of SC treatment with rHuPH20|IV: At baseline; SC/rHuPH20: at baseline then at infusion #1 at ramp-up and at infusions #5, 9, 13 (for 3-week treatment interval) and infusions #4, 7, 10 (for 4-week treatment interval), SC: end of SC treatment and at end of study visit|Participants in the Full Analysis Data Set with available specific antibody test results||Titer||95% Confidence Interval|Median
783960|NCT00814320|Secondary|Antibody Levels to Haemophilus Influenzae|Antibody levels to Haemophilus influenzae after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) at end of IV treatment and end of SC treatment with rHuPH20|IV: At baseline; SC/rHuPH20: at baseline then at infusion #1 at ramp-up and at infusions #5, 9, 13 (for 3-week treatment interval) and infusions #4, 7, 10 (for 4-week treatment interval), SC: end of SC treatment and at end of study visit|Participants in Full Analysis Data Set with available specific antibody test results||μg/mL||95% Confidence Interval|Median
783961|NCT00814320|Secondary|Antibody Levels to Tetanus (Clostridium Tetani Toxoid)|Antibody levels to Tetanus (Clostridium tetani toxoid) after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) at end of IV treatment and end of SC treatment with rHuPH20|IV: At baseline; SC/rHuPH20: at baseline then at infusion #1 at ramp-up and at infusions #5, 9, 13 (for 3-week treatment interval) and infusions #4, 7, 10 (for 4-week treatment interval), SC: end of SC treatment and at end of study visit|Participants in Full Analysis Data Set with available specific antibody test results||IU/mL||95% Confidence Interval|Median
783962|NCT00814320|Secondary|Trough Levels of IgG Subclasses After Administration of IGIV, 10% Given Via IV or SC With rHuPH20|Trough levels of immunoglobulin (IgG) subclasses after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up by IgG subclasses 1 to 4 at end of IV treatment and end of SC treatment with rHuPH20 IgG subclass 1 (IgG 1) IgG subclass 2 (IgG 2) IgG subclass 3 (IgG 3) IgG subclass 4 (IgG 4)|IgG subclasses (1-4) trough levels measured at baseline and on day of each 3- or 4-week infusion for infusion for IV and SC (except during ramp up for SC) and at end of study visit|Participants who have been exposed to either or both study drugs with available IgG subclass trough level measurements||mg/dL||95% Confidence Interval|Median
783963|NCT00814320|Secondary|Trough Levels of IgG After Administration of IGIV, 10% Given Via IV or SC With rHuPH20|Trough levels of immunoglobulin (IgG) after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up|IgG trough levels measured at baseline and on day of each 3- or 4-week infusion for IV and SC (except during ramp up for SC) and at end of study visit.|Full Analysis Data Set||g/L||95% Confidence Interval|Median
784603|NCT00826267|Secondary|Number of Participants Who Achieved Clinical Benefit (CB)|CB was defined as CR, PR or stable disease (SD) and was assessed according to RECIST criteria regardless of treatment status.|Tumour assessments were performed at screening, day 22 and day 43.|TS||Participants|||Number
783964|NCT00814320|Secondary|Annual Rate of All Infections Per Participant|"Annual rate of all infections per participant after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up.
Point estimates and 95% CIs for the annual rates will be calculated using a Poisson model and the same methodology including allowance for over-dispersion as described for the primary endpoint."|Throughout the study period (17 months)|Full Analysis Data Set||Estimated infections/year||95% Confidence Interval|Number
783965|NCT00814320|Secondary|Bioavailability (AUC) of IgG After SC Administration of IGIV, 10%, Given With and Without rHuPH20|"Bioavailability of immunoglobulin (IgG) after subcutaneous (SC) administration of immune globulin intravenous (IGIV), 10%, with and without recombinant human hyaluronidase (rHuPH20) (from current study 160603 and study 160601, respectively), as measured by ratio of AUC of IgG per dose/kg with versus without rHuPH20.
Expressed as a percentage.
This was analysed for participants in Stratum A , participants in Stratum B and for all participants who received IGIV, 10% via SC administration (Stratum A plus Stratum B):
Stratum A: Participants who provided data both on SC with AND without rHuPH20 ie, participants who participated in both studies 160601 and 160603; Stratum B: Participants who provided data on SC with OR without rHuPH20, but not on both (participants who participated in study 160601 OR 160603, but not in both studies)."|PK: 160603 (IV: before infusion (inf.) #4 [3-week treatment interval] or inf. #3 [4-week treatment interval];SC: before last SC inf.) 1 hour pre-inf. ≤28 days (+/-2 days) post-inf.; 160601- 1 hour pre-inf. (before inf. #8) ≤7 days (+/-1 day) post-inf.|Participants in the Full Analysis Data Set aged ≥ 12 years from the current study (160603) and prior Baxter study 160601 who received IGIV, 10% via SC administration||Percentage||90% Confidence Interval|Number
783966|NCT00814320|Secondary|Bioavailability (Trough Levels) of IgG After Administration of IGIV, 10% Given Via IV or SC With rHuPH20 in Participants Aged 2 to < 12 Years|Bioavailability expressed as pharmacokinetic (PK) equivalence of immunoglobulin (IgG) in terms of trough levels after administration of immune globulin intravenous (IGIV), 10% given via subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up to intravenous (IV) route, i.e. ratio of AUC/week of SC/rHuPH20 versus IV administration of IGIV, 10%. Expressed as a percentage.|IgG trough levels measured at baseline and on day of each 3- or 4-week infusion for infusion for IV and SC (except during ramp-up for SC) and at end of study visit|Participants aged 2 to < 12 years exposed to either or both study drugs with available IgG trough level measurements||Percentage||95% Confidence Interval|Number
783967|NCT00814320|Secondary|Bioavailability (AUC) of IgG After Administration of IGIV, 10% Given Via IV or SC With rHuPH20 in Participants ≥12 Years|Bioavailability expressed as pharmacokinetic (PK) equivalence of immunoglobulin (IgG) in terms of ratio of Area Under the Concentration Curve (AUC)/Week after administration of immune globulin intravenous (IGIV), 10% given via subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up to intravenous (IV) route, i.e. ratio of AUC/week of SC/rHuPH20 versus IV administration of IGIV, 10%. Expressed as a percentage.|PK AUC evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval];SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion|"Participants ≥ 12 years exposed to either or both study drugs with AUC measurements at the following time points:
Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*
*Measurements at Day 28 for the 4-week treatment interval only"||Percentage||90% Confidence Interval|Number
783968|NCT00814320|Primary|Validated Acute Serious Bacterial Infection (VASBI) Rate|"Serious acute bacterial infections include bacteremia/sepsis, bacterial meningitis, osteomyelitis/septic arthritis, bacterial pneumonia, and visceral abscess that are caused by a recognized bacterial pathogen.
VASBI rate is the mean number of VASBIs per participant per year, recorded for SC Administration of IGIV, 10%, with rHuPH20 after ramp-up, only.
The mean number of VASBIs per participant per year and the 99% upper confidence limit for the acute serious bacterial infection rate were calculated using a Poisson model to account for the length of the observation periods per participant."|Throughout the study period (17 months)|||Estimated infections/year|||Number
783969|NCT00814333|Primary|Cessation of Epistaxis||baseline, day 4-6|No participants started treatment on this study. Study was closed before any study related procedures were administered.|||||
783970|NCT00814346|Secondary|Change in Brain Morphology in the MC and CNE Groups as Determined by the Change in Voxel Size|Evolution of brain morphology (degree of cortical atrophy) after 18 months with EGb761, using MRI voxel based morphometry|From Baseline (Month 0) to Month 18|ITT population.||mm3||Full Range|Median
783971|NCT00814346|Secondary|Incidence of Adverse Events (AEs)|"The relationship of an adverse event to the study medication will be classified according to the following criteria:
Related : reports including good reasons and sufficient information (e.g. temporal relationship, dose-response relationship, pharmacology, positive de-challenge and/or re-challenge) to assume a causal relationship with the study drug in the sense that it is plausible, conceivable, or likely
Not related: reports including good reasons and sufficient information (e.g. no temporal relationship and/or attributable to concurrent disease or other drugs) to rule out a causal relationship with the study drug."|Up to Month 18|Safety population. CNE patients withdrew during the double-blind phase and were also not included in the safety population for open phase (17 months).||participants|||Number
783972|NCT00814346|Secondary|Number of Subjects Conversion to Alzheimer’s Dementia Diagnosed According to NINCDS-ADRDA (Diagnostic of Alzheimer’s)|The most widely accepted diagnostic criteria for probable AD are those offered by the National Institute of Neurological and Communicative Disorders and Stroke and by the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA; McKhann et al., 1984). These criteria include the presence of dementia established by clinical examination and confirmed by neuropsychological testing. The dementia is described as involving multiple, progressive cognitive deficits in older persons in the absence of disturbances of consciousness, presence of psychoactive substances, or any other medical, neurological, or psychiatric conditions that might in and of themselves account for these progressive deficits.|At Month 18|ITT population. N=Number of subjects with assessment.||participants|||Number
783973|NCT00814346|Secondary|Number of Subjects Conversion to Alzheimer’s Dementia Diagnosed According to the DSM IV (Diagnostic of Dementia)|The Diagnostic and Statistical Manual of Mental Disorders: 4th Edition of the American Psychiatric Association (DSM-IV, 1994) also outlines diagnostic criteria for dementia of the Alzheimer's type that are generally consistent with the NINCDS-ADRDA criteria.|At Month 18|ITT population. N=Number of subjects with assessment.||participants|||Number
783974|NCT00814346|Secondary|Change in Cognitive Tests-Time to Perform TMT in MC and CNE Groups|"TMT is a neuropsychological test of visual attention and task switching. The task requires a subject to 'connect-the-dots' of 25 consecutive numbers (1,2,3,etc.) on a sheet of paper or computer screen. The goal of the subject is to finish the test as quickly as possible and the time taken to complete the test is used as the primary performance metric (in seconds). The maximum time allowed is 300 seconds. A negative change score indicates improvement.
First, in the TMT A, the subject has to connect numbers increasingly as fast as possible.The TMT B requires the subject to connect and letters in an alternating pattern (1-A-2-B-3-C, etc.) in as little time as possible."|From Baseline (Month 0) to Month 18|ITT population. N=Number of subjects with assessment.||Seconds||Full Range|Median
783975|NCT00814346|Secondary|Change in Cognitive Tests-Age-Adjusted WAIS in MC and CNE Groups|"Wechsler Adult Intelligence Scale (WAIS) In this test subjects are asked to say how two seemingly dissimilar items might in fact be similar (14 item couples). This test involves especially abstract thinking and concept capacities.
Cognitive Tests-Age-Adjusted Wechsler Adult Intelligence Scale (WAIS): 19 tests on similarities. The items 1 to 5 are graded from 1 (good) to 0 (bad), and the items 6 to 19 are graded from 2 (good) to 0 (bad). Item 6 and 7 can be repeated. At the end, the worst total score is 0, the best total score is 33."|From Baseline (Month 0) to Month 18|ITT population. N=Number of subjects with assessment.||Age adjusted score||Full Range|Median
783976|NCT00814346|Secondary|Change in Cognitive Tests-Age-Adjusted Logical Memory (MEM III) in MC and CNE Groups|"Subjects are asked to memorize two short stories, one consisting of 24, the other one of 26 information units. After the stories have been read aloud by the investigator, subjects are asked to enounce all items of information they can remember (free recall). Correctly reported items are added for each story. This test applies analytical capacities, as well as auditive and verbal synthesis, working memory and episodic memory.
Score range from 0(worst) to 75 (better)."|From Baseline (Month 0) to Month 18|ITT population. N=Number of subjects with assessment.||Age adjusted score||Full Range|Median
783977|NCT00814346|Secondary|Change in Cognitive Tests in MC and CNE Groups - Total Immediate Recall and Delayed Recall Scores of FCSRT|"Free and Cued Selective Reminding Test (FCSRT) Assessment of verbal episodic memory. By this test performances in free recalls, cued recalls and in a recognition task can be analysed, because the process of encoding is controlled.
Subjects are asked to remember a list of 16 words. Three tasks of free and cued recalls, as well as one recognition task and one delayed recall give the scores.
Total recall is obtained by the addition of cued recalls to free recalls. Maximum score is 48 for immediate: 16 words X 3 corresponding to immediate free recall + immediate cued recall + immediate recognition test.
Maximum score is 64 (better score) when delayed recall : 16 words X 4 . The minimum score is 0 (worse)."|From Baseline (Month 0) to Month 18|ITT population. N=Number of subjects with assessment.||Recall score||Full Range|Median
783978|NCT00814346|Secondary|Change in Cognitive Tests-Cube Drawing Test Score in MC and CNE Groups|"Cube drawing: Subjects are asked to draw a cube by heart. In case of failure, a model of a cube is given to the subjects to copy.
The score system ranges from 0 (worse score) to 6 (best score). Score calculation is following: 1 point by face with 4 sides, 2 points for each face where each angle should be respected."|From Baseline (Month 0) to Month 18|ITT population. N=Number of subjects with assessment.||Cube drawing test score||Full Range|Median
783979|NCT00814346|Secondary|Change in Cognitive Tests-Clock Drawing Test Score in MC and CNE Groups|Clock drawing test is a visuo-constructive task, where subjects are asked to draw the face of a clock in a pre-drawn circle and then to draw in the arms to denote 16:45 (a quarter to five). The drawing can then be evaluated by a quantitative scoring method, which is based on the degree of completion of the drawing. The scoring system ranges from 0 to 6 with higher scores reflecting a greater number of errors and more impairment.|From Baseline (Month 0) to Month 18|ITT population. N=Number of subjects with assessment.||Clock drawing test score||Full Range|Median
783980|NCT00814346|Secondary|Change in Cognitive Tests-MMSE Score in MC and CNE Groups|MMSE is a brief screening instrument used to assess cognitive function in elderly participants. It assesses orientation, memory, attention, ability to name objects, follow verbal and written commands, write a sentence, and copy figures. Total score ranges from 0 to 30, with a lower score indicating greater disease severity.|From Baseline (Month 0) to Month 18|ITT population. N=Number of subjects with assessment.||MMSE Score||Full Range|Median
783981|NCT00814346|Secondary|Change in Cognitive Tests-Verbal Fluency in MC and CNE Groups|"Subjects completed a verbal fluency test. Higher scores represent higher levels of verbal fluency. Minimum score=0 and Maximum score= N/A.
Letter fluency: this task consists of enouncing as many words as possible that begin with a given letter of the alphabet. Participants are not allowed to use proper names.
Categorical fluency: in this task participants are asked to list as many words as possible that belong to a given semantic category (e.g. animals, fruits, towns) Each condition foresees 60 sec of word generation time. The score corresponds to the number of words correctly given. The verbal fluency task measures semantic storage and executive retrieval functions."|From Baseline (Month 0) to Month 18|ITT population. N=Number of subjects with assessment.||Number of good answers||Full Range|Median
783982|NCT00814346|Secondary|Change in Cognitive Tests-GDS Score in MC and CNE Groups|The Geriatric Depression Scale is a self-administered depression scale, which was developed as a basic screening measure for depression in older adults. By “yes” or “no” answers, scores permit to classify patients into groups of “severely depressed” (score of 21 to 30), “moderately depressed” (score of 11 to 20) and “normal” (score of 0 to10). It takes10 to 15 minutes to administer.|From Baseline (Month 0) to Month 18|ITT population. N=Number of subjects with assessment.||GDS Score||Full Range|Median
783983|NCT00814346|Secondary|Change in Cognitive Tests-CDR Score in MC and CNE Groups|CDR is a structured interview to collect information regarding subject's memory in a standard way from both the patient and the helper. Scores are calculated using below scale; q CDR=No dementia (score: 0), q CDR=Very mild dementia (score: 0.5), q CDR=Mild dementia (score: 1), q CDR=Moderate dementia (score: 2) and q CDR=Severe dementia (score: 3)|From Baseline (Month 0) to Month 18|ITT population. N=Number of subjects with assessment.||CDR overall score||Full Range|Median
784021|NCT00814580|Secondary|Sleep Quality: Feeling Alert During Daytime Hours? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)|"Over the past 7 days patients reported Feeling alert during daytime hours by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7)."|Baseline and 7 Days|Tapentadol IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).||participants|||Number
783984|NCT00814346|Secondary|Number of Subjects Conversion to Alzheimer’s Dementia Diagnosed According to NINCDS-ADRDA (Diagnostic of Alzheimer’s)|The most widely accepted diagnostic criteria for probable AD are those offered by the National Institute of Neurological and Communicative Disorders and Stroke and by the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA; McKhann et al., 1984). These criteria include the presence of dementia established by clinical examination and confirmed by neuropsychological testing. The dementia is described as involving multiple, progressive cognitive deficits in older persons in the absence of disturbances of consciousness, presence of psychoactive substances, or any other medical, neurological, or psychiatric conditions that might in and of themselves account for these progressive deficits.|At Month 9|ITT population. N=Number of subjects with assessment.||participants|||Number
783985|NCT00814346|Secondary|Number of Subjects Conversion to Alzheimer’s Dementia Diagnosed According to the DSM IV (Diagnostic of Dementia)|"The Diagnostic and Statistical Manual of Mental Disorders: 4th Edition of the American Psychiatric Association (DSM-IV, 1994) also outlines diagnostic criteria for dementia of the Alzheimer's type that are generally consistent with the NINCDS-ADRDA criteria.
National Institute of Neurological and Communicative Diseases and Stroke / Alzheimer’s Disease and Related Disorders Association (NINCDS/ADRDA)"|At Month 9|ITT population. N=Number of subjects with assessment||participants|||Number
783986|NCT00814346|Secondary|Change in Cognitive Tests-Time to Perform Trail Making Test (TMT) in MC and CNE Groups|"TMT is a neuropsychological test of visual attention and task switching. The task requires a subject to 'connect-the-dots' of 25 consecutive numbers (1,2,3,etc.) on a sheet of paper or computer screen. The goal of the subject is to finish the test as quickly as possible and the time taken to complete the test is used as the primary performance metric (in seconds). The maximum time allowed is 300 seconds. A negative change score indicates improvement.
First, in the TMT A, the subject has to connect numbers increasingly as fast as possible.
The TMT B requires the subject to connect and letters in an alternating pattern (1-A-2-B-3-C, etc.) in as little time as possible."|From Baseline (Month 0) to Month 9|ITT population. N=Number of subjects with assessment.||Seconds||Full Range|Median
783987|NCT00814346|Secondary|Change in Cognitive Tests-Age-Adjusted Wechsler Adult Intelligence Scale (WAIS) in MC and CNE Groups|"Wechsler Adult Intelligence Scale (WAIS) In this test subjects are asked to say how two seemingly dissimilar items might in fact be similar (14 item couples). This test involves especially abstract thinking and concept capacities.
Cognitive Tests-Age-Adjusted Wechsler Adult Intelligence Scale (WAIS): 19 tests on similarities. The items 1 to 5 are graded from 1 (good) to 0 (bad), and the items 6 to 19 are graded from 2 (good) to 0 (bad). Item 6 and 7 can be repeated. At the end, the worst total score is 0, the best total score is 33."|From Baseline (Month 0) to Month 9|ITT population. N=Number of subjects with assessment.||Age adjusted score||Full Range|Median
783988|NCT00814346|Secondary|Change in Cognitive Tests-Age-Adjusted Logical Memory (MEM III) in MC and CNE Groups|"Subjects are asked to memorize two short stories, one consisting of 24, the other one of 26 information units. After the stories have been read aloud by the investigator, subjects are asked to enounce all items of information they can remember (free recall). Correctly reported items are added for each story. This test applies analytical capacities, as well as auditive and verbal synthesis, working memory and episodic memory.
Score range from 0(worst) to 75 (better)."|From Baseline (Month 0) to Month 9|ITT population. N=Number of subjects with assessment.||Age adjusted score||Full Range|Median
783989|NCT00814346|Secondary|Change in Cognitive Tests in MC and CNE Groups - Total Immediate Recall and Delayed Recall Scores of the Free and Cued Selective Reminding Test (FCSRT)|"Free and Cued Selective Reminding Test (FCSRT) Assessment of verbal episodic memory. By this test performances in free recalls, cued recalls and in a recognition task can be analysed, because the process of encoding is controlled.
Subjects are asked to remember a list of 16 words. Three tasks of free and cued recalls, as well as one recognition task and one delayed recall give the scores.
Total recall is obtained by the addition of cued recalls to free recalls. Maximum score is 48 for immediate: 16 words X 3 corresponding to immediate free recall + immediate cued recall + immediate recognition test.
Maximum score is 64 (better score) when delayed recall : 16 words X 4 . The minimum score is 0 (worse)."|From Baseline (Month 0) to Month 9|ITT population. N=Number of subjects with assessment.||Recall score||Full Range|Median
783990|NCT00814346|Secondary|Change in Cognitive Tests-Cube Drawing Test Score in MC and CNE Groups|"Cube drawing: Subjects are asked to draw a cube by heart. In case of failure, a model of a cube is given to the subjects to copy.
The score system ranges from 0 (worse score) to 6 (best score). Score calculation is following: 1 point by face with 4 sides, 2 points for each face where each angle should be respected."|From Baseline (Month 0) to Month 9|ITT population. N=Number of subjects with assessment.||Cube drawing test score||Full Range|Median
783991|NCT00814346|Secondary|Change in Cognitive Tests-Clock Drawing Test Score in MC and CNE Groups|Clock drawing test is a visuo-constructive task, where subjects are asked to draw the face of a clock in a pre-drawn circle and then to draw in the arms to denote 16:45 (a quarter to five). The drawing can then be evaluated by a quantitative scoring method, which is based on the degree of completion of the drawing. The scoring system ranges from 0 to 6 with higher scores reflecting a greater number of errors and more impairment.|From Baseline (Month 0) to Month 9|ITT population. N=Number of subjects with assessment.||Clock drawing test score||Full Range|Median
783992|NCT00814346|Secondary|Change in Cognitive Tests-Mini Mental Status Examination (MMSE) Score in MC and CNE Groups|MMSE is a brief screening instrument used to assess cognitive function in elderly participants. It assesses orientation, memory, attention, ability to name objects, follow verbal and written commands, write a sentence, and copy figures. Total score ranges from 0 to 30, with a lower score indicating greater disease severity.|From Baseline (Month 0) to Month 9|ITT population. N=Number of subjects with assessment.||MMSE Score||Full Range|Median
783993|NCT00814346|Primary|Change in Brain Glucose Metabolism Measured Using 18-Fluorodeoxyglucose Positron Emission Tomography (18FDG-PET)|"Following statistical parametric mapping (SPM) analyses were performed by the Commissariat à l’Energie Atomique (CEA):
The comparison between treatment groups separately for each group of elderly subjects (CNE and MC groups only)
The comparison between the two groups of elderly subjects (CNE and MC groups only) by treatment group
FDG PET demonstrates reductions in the cerebral glucose metabolism that may occur a few years before the overt clinical manifestation of disease.
SUVBSA2 = [Brain radioactivity (Bq/cc)] / [Injected dose (MBq)/BSA2] x [Blood glucose (g/l)]
BSA2(m^2) = 0.007184 x Height (cm)^0.35 x weight (kg)^0.80
Standardized Uptake Value (SUV) Body Surface Area (BSA)"|From Baseline (Month 0) to Week 4 (Month 1) - Double blind phase|Intention to treat (ITT) population: All treated CNE and MC patients||SUVBSA2||Full Range|Median
783994|NCT00814346|Secondary|Change in Cognitive Tests-Verbal Fluency in MC and CNE Groups|"Subjects completed a verbal fluency test. Higher scores represent higher levels of verbal fluency. Minimum score=0 and Maximum score= N/A.
Letter fluency: this task consists of enouncing as many words as possible that begin with a given letter of the alphabet. Participants are not allowed to use proper names.
Categorical fluency: in this task participants are asked to list as many words as possible that belong to a given semantic category (e.g. animals, fruits, towns) Each condition foresees 60 sec of word generation time. The score corresponds to the number of words correctly given. The verbal fluency task measures semantic storage and executive retrieval functions."|From Baseline (Month 0) to Month 9|ITT population. N=Number of subjects with assessment.||Number of good answers||Full Range|Median
783995|NCT00814346|Secondary|Change in Cognitive Tests-Geriatric Depression Scale (GDS) Score in MC and CNE Groups|The Geriatric Depression Scale is a self-administered depression scale, which was developed as a basic screening measure for depression in older adults. By “yes” or “no” answers, scores permit to classify patients into groups of “severely depressed” (score of 21 to 30), “moderately depressed” (score of 11 to 20) and “normal” (score of 0 to10). It takes10 to 15 minutes to administer.|From Baseline (Month 0) to Month 9|ITT population. N=Number of subjects with assessment.||GDS Score||Full Range|Median
783996|NCT00814346|Secondary|Change in Cognitive Tests-Clinical Dementia Rating (CDR) Score in MC and CNE Groups|CDR is a structured interview to collect information regarding subject's memory in a standard way from both the patient and the helper. Scores are calculated using below scale; q CDR=No dementia (score: 0), q CDR=Very mild dementia (score: 0.5), q CDR=Mild dementia (score: 1), q CDR=Moderate dementia (score: 2) and q CDR=Severe dementia (score: 3).|From Baseline (Month 0) to Month 9|ITT population. N=Number of subjects with assessment.||CDR overall score||Full Range|Median
783997|NCT00814346|Secondary|Change in Brain Glucose Metabolism in the MC and CNE Groups|"Brain glucose metabolism measured by 18FDG PET
SUVBSA2 = [Brain radioactivity (Bq/cc)] / [Injected dose (MBq)/BSA2] x [Blood glucose (g/l)]
BSA2(m^2) = 0.007184 x Height (cm)^0.35 x weight (kg)^0.80"|From Baseline (Month 0) to Month 18|ITT population. N=Number of subjects with assessment.||SUVBSA2||Full Range|Median
783998|NCT00814463|Secondary|Overall Survival||12 months||||||
783999|NCT00814463|Secondary|Rate of Death Due to Neurologic Causes||12 months||||||
784000|NCT00814463|Secondary|Clinical Significance (if Any) of Locally Recurrent Brain Metastasis at the Time of Their Occurrence (Mass Effect, Cognitive Functioning, and Other Symptoms)||12 months||||||
784001|NCT00814463|Secondary|Preservation of Neurocognitive Function as Measured by the Mini-Mental State Exam||Every 3 months for 12 months.||||||
784002|NCT00814463|Secondary|Quality of Life as Measured by the FACT-Br Subscales||Every 3 months for 12 months||||||
784003|NCT00814463|Secondary|Rate of New Brain Metastases Outside of the Adjuvant SRS Site||12 months||||||
784004|NCT00814463|Secondary|Rate of Salvage Whole-brain Radiotherapy, Stereotactic Radiosurgery (SRS), or Surgery||12 months||||||
784005|NCT00814463|Primary|Recurrence Rate at the Surgical Site as Measured by MRI|The number of months for local recurrence via MRI|12 months|||Months|||Number
784006|NCT00814489|Primary|Number of Subjects With Any Hematological Laboratory Abnormalities|"Hematological parameters assessed in blood samples include red blood cells (RBC), white blood cells (WBC - including Basophils (BAS), neutrophils (NEU), lymphocytes (LYM), eosinophils (EOS) and monocytes (MON)), blood platelets (PLA) and Hemoglobin (HEM). Abnormalities reported include values outside the normal ranges.
This outcome presents results for BAS, NEU, LYM, EOS and MON. Time points were presented as before (Pre) or after (Post) Dose 1, 2 or 3."|During a 7-day follow up period after vaccine dose 1 and 2 and at Days 180, 300 and 420.|The analysis was based on the Total Vaccinated Cohort, which included all subjects with at least one study vaccine administration documented.||Subjects|||Number
784007|NCT00814489|Primary|Number of Subjects With Any Hematological Laboratory Abnormalities|"Hematological parameters assessed in blood samples include red blood cells (RBC), white blood cells (WBC - including Basophils (BAS), neutrophils (NEU), lymphocytes (LYM), eosinophils (EOS) and monocytes (MON), blood platelets (PLA) and Hemoglobin (HEM). Abnormalities reported include values outside the normal ranges.
This outcome presents results for RBC, WBC High and Low, PLA and HEM. Time points were presented as before (pre) or after (post) doses 1, 2 or 3."|During a 7-day follow up period after vaccine dose 1 and 2 and at Days 180, 300 and 420.|The analysis was based on the Total Vaccinated Cohort, which included all subjects with at least one study vaccine administration documented.||Subjects|||Number
784008|NCT00814489|Secondary|Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.|"The mean number was calculated for CD8+ cells stimulated by protein D (PD), pneumococcal histidine triad D (PhtD) and pneumolysin toxoid (dPly) and expressing the following citokine combinations:
C1= at least interleukin 2 (IL2), tumor necrosis factor alpha (TNFa) and/or interferon-gamma (IFNg) and C2= at least interleukin 17 (IL17)."|Prior to first vaccination (Day 0), at 14 days post vaccination 1 (Day 14) and 2 (Day 74) and at Day 480.|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received at least one dose of study vaccine/comparator and for whom data concerning immunogenicity measures were available.||T-cells/million cells||Standard Deviation|Mean
784009|NCT00814489|Secondary|Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.|"The mean number was calculated for CD4+ cells stimulated by protein D (PD), pneumococcal histidine triad D (PhtD) or pneumolysin toxoid (dPly), identified as producing T-lymphocyte Helper 1 cells (Th1) versus Th2 cytokines (interferon-gamma (IFN-g) and interleukin-13 (IL-13) respectively, as measured by intracellular staining (ICS) on Peripheral Blood Mononuclear Cells (PBMCs). The outcome presents results for cells producing the following combinations:
Th1=IFN-g, Th 2=IL13 and/or IL5 and Th17=IL17."|Prior to first vaccination (Day 0), at 14 days post vaccination 1 (Day 14) and 2 (Day 74) and at Day 480.|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received at least one dose of study vaccine/comparator and for whom data concerning immunogenicity measures were available.||T-cells/million cells||Standard Deviation|Mean
784022|NCT00814580|Secondary|Sleep Quality: Wake up Feeling Tired and Worn Out? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)|"Over the past 7 days patients reported Wake up feeling tired and worn out by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7)."|Baseline and 7 Days|Oxycodone IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).||participants|||Number
784010|NCT00814489|Secondary|Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD)|Concentrations were given as Geometric Mean Concentrations (GMCs). The cut-off values were 112 Luminex Units per milliliter (LU/mL) for Anti-PD, 391 LU/mL for Anti-PhtD and 591 LU/mL for Anti-Ply.|Days 0, 30, 60, 90, 180 and 420.|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received at least one dose of study vaccine/comparator and for whom data concerning immunogenicity measures were available.||LU/mL||95% Confidence Interval|Geometric Mean
784011|NCT00814489|Primary|Number of Subjects With Any Biochemical Laboratory Abnormalities|"Biochemical parameters assessed in blood samples include alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA) and urea (URE).
Abnormalities reported include values outside the normal ranges. Time points were presented as before (Pre) or after (Post) Dose 1, 2 or 3."|During a 7-day follow up period after vaccine dose 1 and 2 and at Days 180, 300 and 420|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one study vaccine administration documented.||Subjects|||Number
784012|NCT00814489|Primary|Number of Subjects With Any Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination.|From Day 0 to Day 420|The analysis was based on the Total Vaccinated Cohort, which included subjects with at least one study vaccine administration documented.||Subjects|||Number
784013|NCT00814489|Primary|Number of Subjects With Any Unsolicited Adverse Events (AE)|"An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event."|During a 30-day (Days 0-29) follow up period after any vaccination|The analysis was based on the Total Vaccinated Cohort, which included all subjects with at least one study vaccine administration documented.||Subjects|||Number
784014|NCT00814489|Primary|Number of Subjects With Any Solicited Local and General Symptoms|"Solicited local symptoms assessed were pain, redness and swelling. Any solicited local symptom was defined as occurrence of any solicited local symptom regardless of intensity grade.
Solicited general symptoms assessed were fatigue, gastrointestinal, headache, malaise, myalgia and temperature Any temperature was defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C). For other symptoms: Any = any general symptom reported irrespective of intensity grade and relationship to vaccination."|During a 7-day follow up period after any vaccination|The analysis was based on the Total Vaccinated Cohort, which included all subjects with at least one study vaccine administration documented.||Subjects|||Number
784015|NCT00814502|Secondary|Measures of Aggression, Psychosis, General Clinical Status, Cognitive Measures, Mood Symptoms|"Rating Scale for Aggressive Behavior in the Elderly (RAGE, 0-61); higher is worse.
Disruptive Behavior Rating Scales (DBRS, 0-105); higher is worse.
Neuropsychiatric Inventory (NPI, 0-144) – measures 12 different domains of neuropsychiatric symptoms such as delusions, hallucinations, anxiety, depression, apathy, etc.; higher is worse.
Montgomery-Asberg Depression Rating Scale (MADRS, 0-90); higher is worse.
Mini-mental state examination (MMSE, 0-30); higher is better.
The time period was different for each patient, it was their duration of hospitalization. The first 48 hours patients were not on the study drug, so the reported least squares mean is an estimate of the mean for the subsequent time period where the patients received different therapies. These means are corrected for differences that might have existed during the first 48 hours. The results would be similar to the results attained from considering the mean during the firs"|post-intervention, up to 3 weeks|||units on a scale||Standard Error|Least Squares Mean
784016|NCT00814502|Primary|Sleep Minutes|"Total sleep minutes during the down period. The down interval signifies the period of time (in minutes) at night when subjects are in bed and trying to sleep.
The time period was different for each patient, it was their duration of hospitalization. The first 48 hours patients were not on the study drug, so the reported least squares mean is an estimate of the mean for the subsequent time period where the patients received different therapies. These means are corrected for differences that might have existed during the first 48 hours. The results would be similar to the results attained from considering the mean during the first 48 hours as a baseline covariate in an Analysis of Covariance, but would be more robust to missing data."|post-intervention, up to 3 weeks|||sleep minutes||Standard Error|Least Squares Mean
784017|NCT00814502|Primary|Sleep Efficiency|"Sleep efficiency during the down interval. The down interval signifies the period of time (in minutes) at night when subjects are in bed and trying to sleep. Sleep efficiency is calculated as (100*sleep minutes)/[time interval from sleep onset (as defined by the sleep latency) to sleep offset (the end of the last sleep episode in the Down interval)].
The time period was different for each patient, it was their duration of hospitalization. The first 48 hours patients were not on the study drug, so the reported least squares mean is an estimate of the mean for the subsequent time period where the patients received different therapies. These means are corrected for differences that might have existed during the first 48 hours. The results would be similar to the results attained from considering the mean during the first 48 hours as a baseline covariate in an Analysis of Covariance, but would be more robust to missing data."|Post-intervention, up to 3 weeks|||percentage of sleep (see above)||Standard Error|Least Squares Mean
784018|NCT00814580|Secondary|Sleep Quality: Feeling Well Rested? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)|"Over the past 7 days patients reported Feeling well rested by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7)."|Baseline and 7 Days|Oxycodone IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).||participants|||Number
784019|NCT00814580|Secondary|Sleep Quality: Feeling Well Rested? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)|"Over the past 7 days patients reported Feeling well rested by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7)."|Baseline and 7 Days|Tapentadol IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).||participants|||Number
784093|NCT00822172|Primary|Safety of Combining Cilostazol With L-carnitine by Evaluating Laboratory Abnormalities and Adverse Events (AEs).||Day 0 to Day 210||||||
784023|NCT00814580|Secondary|Sleep Quality: Wake up Feeling Tired and Worn Out? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)|"Over the past 7 days patients reported Wake up feeling tired and worn out by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7)."|Baseline and 7 Days|Tapentadol IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).||participants|||Number
784024|NCT00814580|Secondary|Sleep Quality: Pain Interferes With Sleep? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)|"Over the past 7 days patients reported Pain interferes with sleep by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7)."|Baseline and 7 Days|Oxycodone IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).||participants|||Number
784025|NCT00814580|Secondary|Sleep Quality: Pain Interferes With Sleep? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)|"Over the past 7 days patients reported Pain interferes with sleep by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7)."|Baseline and 7 Days|Tapentadol IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).||participants|||Number
784026|NCT00814580|Secondary|Sleep Quality: Trouble Staying Asleep? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)|"Over the past 7 days patients reported Trouble staying asleep by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7)."|Baseline and 7 Days|Oxycodone IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).||participants|||Number
784027|NCT00814580|Secondary|Sleep Quality: Trouble Staying Asleep? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)|"Over the past 7 days patients reported Trouble staying asleep by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7)."|Baseline and 7 Days|Tapentadol IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).||participants|||Number
784028|NCT00814580|Secondary|Sleep Quality: Wake up Several Times During Night? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)|"Over the past 7 days patients reported Wake up several times during night by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7)."|Baseline and 7 Days|Oxycodone IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).||participants|||Number
784029|NCT00814580|Secondary|Sleep Quality: Wake up Several Times During Night? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)|"Over the past 7 days patients reported Wake up several times during night by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7)."|Baseline and 7 Days|Tapentadol IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).||participants|||Number
784030|NCT00814580|Secondary|Sleep Quality: Trouble Falling Asleep? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)|"Over the past 7 days patients reported trouble falling asleep by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7)."|Baseline and 7 Days|Oxycodone IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).||participants|||Number
784031|NCT00814580|Secondary|Sleep Quality: Trouble Falling Asleep? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)|"Over the past 7 days patients reported trouble falling asleep by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7)."|Baseline and 7 Days|Tapentadol IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).||participants|||Number
784032|NCT00814580|Secondary|Summary of Medical Resource Utilization – Number of Other Types of Contacts With Healthcare Professionals|Information associated with contacts with a healthcare professional was collected by the investigator and study staff for all subjects throughout the study.|7 Days|Intent-to-Treat Population||Number of participants|||Number
784033|NCT00814580|Secondary|Summary of Medical Resource Utilization – Number of Calls by the Subject to Study Site Personnel|Information associated with contacts with a healthcare professional was collected by the investigator and study staff for all subjects throughout the study.|7 Days|Intent-to-Treat Population||Number of calls|||Number
784034|NCT00814580|Secondary|Clinician Global Impression of Change (CGIC) at End of Study|Clinician Global Impression of Change (CGIC) was defined as the 7-point numeric scale, where 1=very much improved to 7=very much worse.|7 Days|Intent-to-Treat Population||percentage of participants|||Number
784035|NCT00814580|Secondary|Patient Global Impression of Change (PGIC) at End of Study|Patient Global Impression of Change (PGIC) was defined as the 7-point numeric scale, where 1=very much improved to 7=very much worse.|7 Days|Intent-to-Treat Population||percentage of participants|||Number
784036|NCT00814580|Secondary|Subject Satisfaction With Treatment|Treatment satisfaction was measured using a 7-point scale where 1 = very satisfied and 7 = very dissatisfied|7 Days|Intent-to-Treat Population||percentage of participants|||Number
784037|NCT00814580|Secondary|Summary and Analysis of the Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) (With Imputation) Over 7 Days|The Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) was derived from Sum of TOTPAR and SPID. The range of SPRID over 7 days is from -1440 to 2016. A higher value in SPRID indicated greater pain relief.|7 Days|The modified Intent-to-Treat(mITT) population was defined as all randomized subjects who took at least one dose of study drug within 24 hours of randomization and had a baseline pain intensity score >= 4 on an 11-point numeric rating scale (NRS).||Scores on a scale||Standard Deviation|Mean
784038|NCT00814580|Secondary|Summary and Analysis of the Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) (With Imputation) Over 3 Days (72 Hours)|The Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) was derived from Sum of TOTPAR and SPID. The range of SPRID over 3 days is from -720 to 1008. A higher value in SPRID indicated greater pain relief.|3 Days (72hours)|The modified Intent-to-Treat(mITT) population was defined as all randomized subjects who took at least one dose of study drug within 24 hours of randomization and had a baseline pain intensity score >= 4 on an 11-point numeric rating scale (NRS).||Scores on a scale||Standard Deviation|Mean
785106|NCT00835042|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) of Moexipril.|Bioequivalence based on AUC0-t.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
784039|NCT00814580|Secondary|Summary and Analysis of the Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) (With Imputation) Over 2 Days (48 Hours)|The Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) was derived from Sum of TOTPAR and SPID. The range of SPRID over 2 days is from -480 to 672. A higher value in SPRID indicated greater pain relief.|2 Days (48 hours)|The modified Intent-to-Treat(mITT) population was defined as all randomized subjects who took at least one dose of study drug within 24 hours of randomization and had a baseline pain intensity score >= 4 on an 11-point numeric rating scale (NRS).||Scores on a scale||Standard Deviation|Mean
784040|NCT00814580|Secondary|Summary and Analysis of Total Pain Relief (TOTPAR) (With Imputation) Over 7 Days|Pain Relief was defined as a 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum over all pain relief up to Day 7, 8 AM. The range of TOTPAR over 7 days is from 0 to 576. A higher value in TOTPAR indicated greater pain relief.|7 Days|The modified Intent-to-Treat(mITT) population was defined as all randomized subjects who took at least one dose of study drug within 24 hours of randomization and had a baseline pain intensity score >= 4 on an 11-point numeric rating scale (NRS).||Scores on a scale||Standard Deviation|Mean
784041|NCT00814580|Secondary|Summary and Analysis of Total Pain Relief (TOTPAR) (With Imputation) Over 3 Days (72hours)|Pain Relief was defined as a 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum over all pain relief up to hour 72. The range of TOTPAR over 3 days is from 0 to 288. A higher value in TOTPAR indicated greater pain relief.|3 Days (72hours)|The modified Intent-to-Treat(mITT) population was defined as all randomized subjects who took at least one dose of study drug within 24 hours of randomization and had a baseline pain intensity score >= 4 on an 11-point numeric rating scale (NRS).||Scores on a scale||Standard Deviation|Mean
784042|NCT00814580|Secondary|Summary and Analysis of Total Pain Relief (TOTPAR) (With Imputation) Over 2 Days (48 Hours)|Pain Relief was defined as a 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum over all pain relief up to hour 48. The range of TOTPAR over 2 days is from 0 to 192. A higher value in TOTPAR indicated greater pain relief.|2 Days (48 hours)|The modified Intent-to-Treat(mITT) population was defined as all randomized subjects who took at least one dose of study drug within 24 hours of randomization and had a baseline pain intensity score >= 4 on an 11-point numeric rating scale (NRS).||Scores on a scale||Standard Deviation|Mean
784043|NCT00814580|Secondary|Summary and Analysis of Sum of Pain Intensity Difference (SPID) (With Imputation) Over 7 Days|Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID over 7 Days was calculated as the time-weighted Sum of PID scores up to Day 7, 8 AM. The range is from -1440 to 1440. The higher value in SPID indicates greater pain relief.|7 Days|The modified Intent-to-Treat(mITT) population was defined as all randomized subjects who took at least one dose of study drug within 24 hours of randomization and had a baseline pain intensity score >= 4 on an 11-point numeric rating scale (NRS).||Scores on a scale||Standard Deviation|Mean
784044|NCT00814580|Secondary|Summary and Analysis of Sum of Pain Intensity Difference (SPID) (With Imputation) Over 2 Days (48 Hours)|Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID48 was calculated as the time-weighted Sum of PID scores over 48 hours. The range of SPID48 is from -480 to 480. The higher value in SPID indicates greater pain relief.|2 Days (48 hours)|The modified Intent-to-Treat(mITT) population was defined as all randomized subjects who took at least one dose of study drug within 24 hours of randomization and had a baseline pain intensity score >= 4 on an 11-point numeric rating scale (NRS).||Scores on a scale||Standard Deviation|Mean
784045|NCT00814580|Secondary|Summary of 50% Responder Rate (With Imputation) on Day 7|The 50% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 50% from baseline in pain intensity at Day 7 (average of Day 6 PM and Day 7 AM). If a subject has only the Day 6 PM value or Day 7 AM value, then response rate will be based on the non-missing value. If a subject withdraws or uses rescue medication before Day 6 PM then BOCF will be imputed. LOCF may be used if no value afterward.|Day 7|Modified Intent-to-Treat Population||percentage of participants|||Number
784046|NCT00814580|Secondary|Summary of 50% Responder Rate (With Imputation) on Day 3|The 50% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 50% from baseline in pain intensity at Day 3 (average of Day 3 PM and Day 4 AM). If a subject has only the Day 3 PM value or Day 4 AM value, then response rate will be based on the non-missing value. If a subject withdraws or uses rescue medication before Day 3 PM then BOCF will be imputed. LOCF may be used if no value afterward.|Day 3|Modified Intent-to-Treat Population||percentage of participants|||Number
784047|NCT00814580|Secondary|Summary of 30% Responder Rate (With Imputation) on Day 7|The 30% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 30% from baseline in pain intensity at Day 7 (average of Day 6 PM and Day 7 AM). If a subject has only the Day 6 PM value or Day 7 AM value, then response rate will be based on the non-missing value. If a subject withdraws or uses rescue medication before Day 6 PM then BOCF will be imputed. LOCF may be used if no value afterward.|Day 7|Modified Intent-to-Treat Population||percentage of participants|||Number
784048|NCT00814580|Secondary|Summary of 30% Responder Rate (With Imputation) on Day 3|The 30% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 30% from baseline in pain intensity at Day 3 (average of Day 3 PM and Day 4 AM). If a subject has only the Day 3 PM value or Day 4 AM value, then response rate will be based on the non-missing value. If a subject withdraws or uses rescue medication before Day 3 PM then Baseline Observation Carried Forward (BOCF) will be imputed. Last Observation Carried Forward (LOCF) may be used if no value afterward.|Day 3|Modified Intent-to-Treat Population||percentage of participants|||Number
784094|NCT00822172|Primary|The Effect of Cilostazol Combined With L-carnitine on Change in Peak Walking Time (PWT) Compared to Cilostazol Alone From Baseline/Day 0 to Day 180 in Subjects With Peripheral Artery Disease (PAD) Limited by Intermittent Claudication (IC).||Day 0 to Day 180|The mITT population included all randomized subjects who received at least 1 dose of study medication and completed at least 1 post randomization Exercise Treadmill Test (ETT).||minutes||Standard Deviation|Log Mean
784049|NCT00814580|Secondary|Summary of Kaplan-Meier Estimates for Time to Achieve 30% Reduction in Pain Intensity From Baseline|From date of first administration of study medication to time to achieve adequate 30% reduction in pain intensity from baseline score. Censored observations included subjects who completed or discontinued from the study without a 30% reduction in pain intensity from baseline score. If a subject discontinued due to lack of efficacy (including rescue medication), the subject was censored on Day 7, 12 PM.|7 Days|Modified Intent-to-Treat Population||Hours||95% Confidence Interval|Median
784050|NCT00814580|Secondary|Summary of Kaplan-Meier Estimates for Time to Achieve 50% Reduction in Pain Intensity From Baseline|From date of first administration of study medication to time to achieve adequate 50% reduction in pain intensity from baseline score. Censored observations included subjects who completed or discontinued from the study without a 50% reduction in pain intensity from baseline score. If a subject discontinued due to lack of efficacy (including rescue medication), the subject was censored on Day 7, 12 PM.|7 Days|Modified Intent-to-Treat Population||Hours||95% Confidence Interval|Median
784051|NCT00814580|Primary|Summary and Analysis of Sum of Pain Intensity Difference (SPID) (With Imputation) Over 3 Days (72 Hours)|Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID72 was calculated as the time-weighted Sum of PID scores over 72 hours. The range of SPID72 is from -720 to 720. The higher value in SPID indicates greater pain relief.|3 Days (72 hours)|The modified Intent-to-Treat(mITT) population was defined as all randomized subjects who took at least one dose of study drug within 24 hours of randomization and had a baseline pain intensity score >= 4 on an 11-point numeric rating scale (NRS).||Scores on a scale||Standard Deviation|Mean
784052|NCT00814632|Primary|Global Response Assessment|"The primary efficacy measure was a Global Response Assessment (GRA), a subject completed questionnaire that measures improvement in overall symptoms. The GRA is a 7-point scale the allows the subject to respond to the question: As compared to when you started the study, overall how do you feel? The responses are: Markedly Improved - 7, Moderately Improved - 6, Mildly Improved - 5, Same - 4, Mildly Worse - 3, Moderately Worse - 2, Markedly Worse - 1.
The primary outcome showing response to treatment was the number of subjects that were moderately or markedly improved on the GRA scale."|12 weeks|||participants|||Number
784053|NCT00814658|Secondary|The Neuropsychiatric Inventory (NPI) at Baseline, Week 8, and Week 24|The NPI evaluates 12 neuropsychiatric domains: delusions, hallucinations, dysphoria, anxiety, aggression, euphoria, dis-inhibition, irritability/lability, apathy, aberrant motor activity, eating disorders, and night-time behavior disturbances. For present domains, the severity and frequency of the behavior are determined. Frequency is rated 1 (rarely) to 4 (very often) and Severity is scored 1 (mild) to 3 (severe). The product scores vary from 1 (mild and rarely) to 12 (very often and severe). Total scores vary from 0 (no present domain) to 144 (all domains are present, are often and severe).|Baseline, Week 8, Week 24|Intent to Treat population, which consisted of all participants who used at least 1 study medication dose, had at least 1 evaluation after started use, and with evaluable data at each measurement time point.||scores on a scale||Standard Deviation|Mean
784054|NCT00814658|Secondary|The Clinical Global Impression (CGI) at Week 4, Week 8, Week 16, and Week 24|The Clinical Global Impression (CGI) is a scale to assess treatment response in patients with mental disorders. The Clinical Global Impression Improvement scale (CGI-I) requires the clinician to rate how much the patient's illness has improved or worsened relative to a baseline state. A patient's illness is compared to change over time and rated as: very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse.|Week 4, Week 8, Week 16, Week 24|Intent to Treat population, which consisted of all participants who used at least 1 study medication dose, had at least 1 evaluation after started use, and with evaluable data at each measurement time point.||participants|||Number
784055|NCT00814658|Secondary|The Alzheimer’s Disease Assessment Scale – Cognitive Subscale (ADAS-Cog) at Baseline, Week 8, and Week 24|The ADAS-Cog is a psychometric instrument that evaluates memory, attention, reasoning, language, orientation and praxis using an 11-point Assessment Scale. It has a minimum score of 0 and a maximum severity score of 70, and a higher score indicates more impairment.|Baseline, Week 8, Week 24|Intent to Treat population, which consisted of all participants who used at least 1 study medication dose, had at least 1 evaluation after started use, and with evaluable data at each measurement time point.||scores on a scale||Standard Deviation|Mean
784056|NCT00814658|Primary|The Quality of Life Assessment for Patients With Alzheimer’s Disease (QoL- AD) Total Scores, Based on the Caregiver's Opinion, at Baseline, Week 8, Week 24|The Quality of Life assessment scale for patients with Alzheimer’s disease (QoL-AD), according to the opinion of the caregiver is a 13-item scale with four possible scores for each question (score 1: poor and score 4: excellent). It evaluates the opinion of the caregiver about the patient's quality of life. Total score ranges from 13 to 52. Higher scores represent a better outcome.|Baseline, Week 8, Week 24|Intent to Treat population, which consisted of all participants who used at least 1 study medication dose, had at least 1 evaluation after started use, and with evaluable data at each measurement time point.||scores on a scale||Standard Deviation|Mean
784057|NCT00814658|Primary|The Quality of Life Assessment for Patients With Alzheimer’s Disease (QoL- AD) Total Scores at Baseline, Week 8, Week 24|The Quality of Life assessment scale for patients with Alzheimer’s disease (QoL-AD) is a 13-item scale with four possible scores for each question (score 1: poor and score 4: excellent). Total score ranges from 13 to 52. Higher scores represent a better outcome.|Baseline, Week 8, Week 24|Intent to Treat population, which consisted of all participants who used at least 1 study medication dose, had at least 1 evaluation after started use, and with evaluable data at each measurement time point.||scores on a scale||Standard Deviation|Mean
784058|NCT00814658|Primary|The Quality of Life Assessment for Caregivers of Patients With Alzheimer’s Disease (QoL- AD) Total Scores at Baseline, Week 8, Week 24|The Quality of Life assessment scale for caregivers of patients with Alzheimer’s disease (QoL-AD) is a 13-item scale with four possible scores for each question (score 1: poor and score 4: excellent). It evaluates the caregivers own perceived quality of life. Total score ranges from 13 to 52. Higher scores represent a better outcome.|Baseline, Week 8, Week 24|Intent to Treat population, which consisted of all participants who used at least 1 study medication dose, had at least 1 evaluation after started use, and with evaluable data at each measurement time point.||scores on a scale||Standard Deviation|Mean
784059|NCT00814658|Primary|Reaction Time for Word Recognition and Learning Test at Baseline, Week 8, and Week 24|The reaction time for word recognition and learning test is a computerized attention test that evaluates the patient’s reaction time. This test is similar to the Face Recognition test procedure using Words. The recognition procedure was repeated three times to evaluate a learning effect. The reaction time, assessed per patient, was averaged at each time point for each patient e.g., at baseline, Week 8 and Week 24. This test is part of the Computerized Neuropsychological Test Battery (CNTB).|Baseline, Week 8, Week 24|Intent to Treat population, which consisted of all participants who used at least 1 study medication dose, had at least 1 evaluation after started use, and with evaluable data at each measurement time point.||milliseconds||Standard Deviation|Mean
784060|NCT00814658|Primary|Reaction Time for Face Recognition Test at Baseline, Week 8, and Week 24|The face recognition test is a computerized attention test in which ten unfamiliar faces were presented simultaneously on the computer screen for ten seconds to be remembered. After that, a single face was shown and the patient had to press the button one if he/she remembered or, otherwise, button five. It consisted of a random presentation of ten pre-exposed faces and ten new faces as distracters. The reaction time, assessed per patient, was averaged at each time point for each patient e.g., at baseline, Weeks 8 and 24. This test is part of the Computerized Neuropsychological Test Battery.|Baseline, Week 8, Week 24|Intent to Treat population, which consisted of all participants who used at least 1 study medication dose, had at least 1 evaluation after started use, and with evaluable data at each measurement time point.||milliseconds||Standard Deviation|Mean
784061|NCT00814658|Primary|Reaction Time for Two-choice Reaction Time Test at Baseline, Week 8, and Week 24|The Two-choice reaction time test is a computerized attention test in which the numbers one or five were presented in the center of the computer screen in a random order. The patient had to press the correspondent button in the response box as quickly as possible. The patient’s right finger was put over the button five and the left finger over button one before the test begun. The reaction time, assessed 100 times per patient, was averaged at each time point for each patient e.g., at baseline, Week 8 and Week 24.This test is part of the Computerized Neuropsychological Test Battery (CNTB).|Baseline, Week 8, Week 24|Intent to Treat population, which consisted of all participants who used at least 1 study medication dose, had at least 1 evaluation after started use, and with evaluable data at each measurement time point.||milliseconds||Standard Deviation|Mean
784062|NCT00814658|Primary|Reaction Time for Simple Reaction Time Test at Baseline, Week 8, and Week 24|The Simple Reaction Time is a computerized attention test that evaluates the patient’s reaction time. The number one was presented in the center of the computer screen and the patient had to press this number in the response box as quickly as possible. The reaction time, assessed 100 times per patient, was averaged at each time point for each patient e.g., at baseline, Week 8 and Week 24. The patient’s finger was put over button one before the test begun. This test is part of the Computerized Neuropsychological Test Battery (CNTB).|Baseline, Week 8, Week 24|Intent to Treat population, which consisted of all participants who used at least 1 study medication dose, had at least 1 evaluation after started use, and with evaluable data at each measurement time point.||milliseconds||Standard Deviation|Mean
784063|NCT00814671|Secondary|To Compare Lowenstein Jensen and Bactec MGIT Media With Respect to Proportion of Participants With 8-week Culture Conversion and Time to Culture Conversion||8 weeks||||||
784064|NCT00814671|Secondary|To Determine if Rifapentine Exposures Are Associated With Safety||10 weeks||||||
784065|NCT00814671|Secondary|To Determine if Rifapentine Exposures Are Associated With Microbiological Activity||8 weeks||||||
784066|NCT00814671|Secondary|To Describe the Pharmacokinetics of Rifapentine Administered at Once Daily Doses of 450 mg and 600 mg in the Context of Multidrug Intensive Phase TB Treatment||4 weeks||||||
784067|NCT00814671|Secondary|To Evaluate the Microbiological Activity of Rifapentine Administered at Once Daily Doses of 450 mg and 600 mg in the Context of Multidrug Intensive Phase TB Treatment, Based on Time to Culture Growth in MGIT Liquid Media||8 weeks||||||
784068|NCT00814671|Secondary|To Evaluate the Microbiological Activity of Rifapentine Administered at Once Daily Doses of 450 mg and 600 mg in the Context of Multidrug Intensive Phase TB Treatment, Based on Time to Sputum Culture Conversion||8 weeks||||||
784069|NCT00814671|Primary|To Estimate the Frequency of Side Effects of Rifapentine Administered at Once Daily Doses of 450 mg and 600 mg in the Context of Multidrug Intensive Phase TB Treatment|discontinuation of treatment|10 weeks|safety analysis population||percentage of participants|||Number
784070|NCT00814671|Primary|To Estimate the Microbiological Activity of Rifapentine Administered at Once Daily Doses of 450 mg and 600 mg Based on Proportion of Participants With Culture Conversion||8 weeks|per protocol||percentage of participants w/LJ cx con|||Number
784071|NCT00814697|Primary|Cognitive Assessment Task Scores Before, During and After rTMS.|"Cognitive assessment tasks - Boston Diagnostic Aphasia Examination (BDAE), CFL Category naming (CFL), Mini-Mental State Examination (MMSE) - were administered and scored according to standard procedures before, during and 4 weeks after rTMS.
Higher scores are associated with better cognition; No absolute cut-offs were used here as the outcomes were not categorically assessed.
Total possible score ranges by test, lowest to highest:
BDAE - 0 to 15 CFL - 0 to 62 MMSE - 0 to 30 Full range data and means presented below represents range of scores at 4-weeks post-rTMS treatments."|6 weeks|||units on a scale||Full Range|Mean
784072|NCT00821041|Secondary|Beliefs and Attitudes About Sleep||6 weeks||||||
784073|NCT00821041|Secondary|Pre-Sleep Arousal|Pre-sleep Arousal Scale (cognitive subscale). 8-item measure of cognitive hyperarousal associated with insomnia. The subscale score can range from 8 to 40, with higher scores indicating more hyperarousal.|6 weeks|||PSA Scale||Standard Deviation|Mean
784074|NCT00821041|Primary|Sleep Quality|Sleep Quality was assessed by taking the average of two items: “How well do you feel this morning?” And “How enjoyable was your sleep last night?” (0 = not at all, 4 = very).|6 weeks|||0-4 scale of sleep quality||Standard Deviation|Mean
784095|NCT00822185|Secondary|Vatreptacog Alfa Clot Activity- Mean Residence Time (MRT)|Mean residence time of the unchanged drug in the systemic circulation|during 1-2 days after drug administration|PK analysis set included all the subjects not violating the protocol in a manner that was judged to affect PK endpoint evaluation. One (1) subject did not contribute to PK evaluation.||hours||Geometric Coefficient of Variation|Geometric Mean
784075|NCT00821093|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of the Study (Week 12 + 1 Day, Day 85)|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1 and FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening as covariates.|24 hours post-dose at the end of the study (Week 12 + 1 day, Day 85)|Full analysis set: All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).||Liters||Standard Error|Least Squares Mean
784076|NCT00821093|Primary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 5 Minutes to 11 Hours 45 Minutes Post-dose at the End of the Study (Week 12, Day 84)|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; 1, 2, 3, 4, and 8 hours; 11 hours 10 minutes and 11 hours 45 minutes post-dose at the end of the study (Week 12, Day 84). Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included baseline FEV1 and FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening as covariates.|From 5 minutes to 11 hours 45 minutes post-dose at the end of the study (Week 12, Day 84)|Full analysis set: All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).||Liters||Standard Error|Least Squares Mean
784077|NCT00821119|Secondary|Bronchopulmonary Dysplasia|The incidence of bronchopulmonary dysplasia was calculated based on the number of infants surviving to 36 weeks postmenstrual age and diagnosed with bronchopulmonary dysplasia, according to the definiton of bronchopulmonary dysplasia currently used in the neonatal Unit.|at 36 weeks gestational age|The number of preterm infants surviving to 36 weeks postmenstrual age were eligible for analysis||participants|||Number
784078|NCT00821119|Primary|Mechanical Ventilation Within the First 72h of Life in the Two Study Groups.(NIPPV vs NCPAP)|The primary outcome of the study was the need for intubation within the first 72 hours (h) of life.The need for intubation was made by the attending neonatologist, according to the strict protocol of intubation for ventilation, used in the neonatal Unit|first 3 days of life(72hours)|We estimated a 20% absolute reduction in the need of using endotraqueal ventilation with the early use of NIPPV. A sample size of 100 infants per group was calculated with a power of 80% and an alpha error of 5%.||participants|||Number
784079|NCT00821119|Primary|Need for Endotracheal Ventilation in the First 72 hs of Life|number of participants that needed endotracheal ventilation (failed non invasive ventilation) in the first 72 hours of life|first 72 hs of life|40 - 45% of our previous preterm infants on NCPAP for RDS needed intubation and mechanical ventilation within the first 72h of life. We estimated a 20% absolute reduction in the need of using ETT ventilation with the early use of NIPPV. A sample size of 100 infants per group was calculated with a power of 80% and an alpha error of 5%.||participants|||Number
784080|NCT00821184|Secondary|Improvement of Symptom Severity||3 months||||||
784081|NCT00821184|Primary|Change From Baseline in the Number of Incontinence Episodes Per 24 Hours Measured by Voiding Diaries.||0 week - 12 weeks|||incontinence episodes per 24 hours||Full Range|Mean
784082|NCT00821236|Primary|1 Month Postoperative Lasik Visual Acuity|Visual acuity measured without glasses or contact lenses. LogMar is a method of measuring visual acuity. Generally speaking, the U.S. population is familiar with 20/20 visual acuity reference. Samples of LogMar equivalent values would be 20/20=0.0 LogMar, 20/25=0.1 LogMar, 20/16=-0.1, etc.|1 Month Postoperative|||LogMar||Standard Deviation|Mean
784083|NCT00821236|Primary|1 Week Postoperative Lasik Uncorrected Visual Acuity|Visual acuity measured withouth glasses or contact lenses. LogMar is a method of measuring visual acuity. Generally speaking, the U.S. population is familiar with 20/20 visual acuity reference. Samples of LogMar equivalent values would be 20/20=0.0 LogMar, 20/25=0.1 LogMar, 20/16=-0.1, etc.|1 week post op|||LogMar||Standard Deviation|Mean
784084|NCT00821236|Primary|1 Day Postoperative Lasik Uncorrected Visual Acuity|Visual acuity measured without glasses or contact lenses. LogMar is a method of measuring visual acuity. Generally speaking, the U.S. population is familiar with 20/20 visual acuity reference. Samples of LogMar equivalent values would be 20/20=0.0 LogMar, 20/25=0.1 LogMar, 20/16=-0.1, etc.|1 Day|||LogMar||Standard Deviation|Mean
784085|NCT00822094|Secondary|Rate of Stem Cell Transplant|Number of patients transferred for stem cell transplant|Up to 1 year from randomization|Efficacy Evaluable Analysis Set: All randomized participants who received at least one dose of study medication.||Participants|||Count of Participants
784086|NCT00822094|Secondary|Rate of Aplasia|Patients with Aplasia During Study|Up to 1 year from randomization|Efficacy Evaluable Analysis Set: All randomized participants who received at least one dose of study medication.||Participants|||Count of Participants
784087|NCT00822094|Secondary|Remission Duration|Remission duration was measured from the time the criteria for CR were first met until the first date that disease relapse was objectively documented or until subject death.|Following achievement of CR and up to 1 year from randomization|Efficacy Evaluable Analysis Set: All randomized participants who received at least one dose of study medication.||days||Full Range|Median
784088|NCT00822094|Secondary|Event Free Survival|Progression EFS median|Up to 1 year from randomization|Efficacy Evaluable Analysis Set: All randomized participants who received at least one dose of study medication.||days||95% Confidence Interval|Median
784089|NCT00822094|Secondary|Complete Remission Rate||Following 1st induction, following 2nd induction if applicable|Efficacy Evaluable Analysis Set: All randomized participants who received at least one dose of study medication.||Participants|||Count of Participants
784090|NCT00822094|Primary|Proportion of Subjects Surviving at 1 Year|The proportion of subjects surviving at 1 year was evaluated separately for each arm by the number of subjects alive at 1 year divided by the total number of subjects.|Up to 1 year from randomization|Efficacy Evaluable Analysis Set - All randomized participants who received at least one dose of study medication.||Participants|||Count of Participants
784091|NCT00822172|Secondary|The Effect of the Combination of Cilostazol and L-carnitine on Claudication Onset Time (COT) and Quality of Life (QOL), as Measured Using the Walking Impairment Questionnaire (WIQ) and SF-36v2® at Days 90 and 180.||Day 0 to Days 90 and 180||||||
784092|NCT00822172|Secondary|The Combination of Cilostazol and L-carnitine on PWT Compared to Cilostazol Alone From Baseline/Day 0 to Day 90 in Subjects With Peripheral Artery Disease (PAD) Limited by Intermittent Claudication (IC).||Day 0 to Day 90||||||
784099|NCT00822185|Secondary|Vatreptacog Alfa Clot Activity: Terminal Half-life (t1/2)||during 1-2 days after drug administration|PK analysis set included all the subjects not violating the protocol in a manner that was judged to affect PK endpoint evaluation. One (1) subject did not contribute to data.||hours||Geometric Coefficient of Variation|Geometric Mean
784100|NCT00822185|Secondary|Vatreptacog Alfa Clot Activity- Terminal Slope (λz)||during 1-2 days after drug administration|PK analysis set included all the subjects not violating the protocol in a manner that was judged to affect PK endpoint evaluation. One (1) subject did not contribute to PK evaluation.||1/h||Geometric Coefficient of Variation|Geometric Mean
784101|NCT00822185|Secondary|Vatreptacog Alfa Clot Activity: Back Extrapolated Estimate of the Initial FVIIa Activity (C0)||during 1-2 days after drug administration|PK analysis set included all the subjects not violating the protocol in a manner that was judged to affect PK endpoint evaluation.||IU/mL||Geometric Coefficient of Variation|Geometric Mean
784102|NCT00822185|Secondary|Vatreptacog Alfa Clot Activity: FVIIa Activity Measured 5 Min After Administration of NN1731 (C5min)||during 1-2 days after drug administration|PK analysis set included all the subjects not violating the protocol in a manner that was judged to affect PK endpoint evaluation.||IU/mL||Geometric Coefficient of Variation|Geometric Mean
784103|NCT00822185|Secondary|Vatreptacog Alfa Clot Activity: Maximum FVIIa Activity (Cmax)||during 1-2 days after drug administration|PK analysis set included all the subjects not violating the protocol in a manner that was judged to affect PK endpoint evaluation.||IU/mL||Geometric Coefficient of Variation|Geometric Mean
784104|NCT00822185|Secondary|Vatreptacog Alfa Clot Activity: Area Under the FVIIa Activity-time Curve From Time 0 h to Infinity (AUC 0-inf)|AUC0-inf = AUC0-t + (Ct / λz), Where Ct is the last quantifiable activity and t the time of Ct.|during 1-2 days after drug administration|PK analysis set included all the subjects not violating the protocol in a manner that was judged to affect PK endpoint evaluation. One (1) subject did not contribute to PK evaluation.||(IU*h)/mL||Geometric Coefficient of Variation|Geometric Mean
784105|NCT00822185|Secondary|Vatreptacog Alfa Clot Activity: Area Under the FVIIa Activity-time Curve From Time 0 to 24 h (AUC0-24)|Blood samples were collected at following time points: -30 min, -20 min, -10 min, 5 min, 10 min, 20 min, 30 min, 1 h, 2h, 3h, 4h, 5h, 8h, 12h and 24h to calculate area under the curve.|during 1-2 days after drug administration|PK analysis set included all the subjects not violating the protocol in a manner that was judged to affect PK endpoint evaluation. One (1) subject did not contribute to PK evaluation.||(IU*h)/mL||Geometric Coefficient of Variation|Geometric Mean
784106|NCT00822185|Secondary|Vatreptacog Alfa Clot Activity: Area Under the FVIIa Activity-time Curve From Time 0 and up Until the Last Quantifiable Activity (AUC0-t)|AUC0-t was computed using the linear trapezoid rule. Plasma FVIIa clot activity at time 0 was calculated by log linear interpolation.|during 1-2 days after drug administration|PK analysis set included all the subjects not violating the protocol in a manner that was judged to affect PK endpoint evaluation.||(IU*h)/mL||Geometric Coefficient of Variation|Geometric Mean
784107|NCT00822185|Primary|Subjects With Anti-Vatreptacog Alfa Antibody|Post-dosing samples from subjects were evaluated for the presence of Anti-Vatreptacog alfa antibody|between dosing, 2-3 weeks after dosing, and 11-13 weeks after dosing|Safety analysis set included all the randomised subjects who received at least one dose of the trial product.||participants|||Number
784108|NCT00822185|Primary|Safety (Physical Examination, Vital Signs, ECG, Haematology, Biochemistry, Urinalysis, Coagulation Factors, Coagulation-related Parameters, Injection Site Tolerability and Adverse Events (AE))|Any safety issue was reported as AE|between dosing and 2-3 weeks after dosing|Safety analysis set included all the randomised subjects who received at least one dose of the trial product.||number of events|||Number
784109|NCT00822237|Primary|Percent of Participants Who Achieved Varicella Immunogenicity After a Single Dose of VARIVAX (2007 Process).|"Percent of participants with varicella antibody titer ≥ 5 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) units/mL in participants with baseline varicella antibody titer < 1.25 gpELISA units/mL.
Results for the VARIVAX (1999 Process) arm are not included in this table because the primary outcome measure is for the VARIVAX (2007 Process) arm only."|6 weeks following first vaccination|Per protocol population||Percent of participants|||Number
784110|NCT00822328|Primary|Modification of the Composition of the Intestinal Microflora: Clostridium Perfringens|"Fecal specimens were obtained from all 24 healthy volunteers at week 0, 1, 2, 3, 4, 5, 6.
Clostridium perfringens was cultured.Bacterial colonies were counted."|week 0, 1, 2, 3, 4, 5, 6.|||log10 CFU/g||Standard Deviation|Log Mean
784111|NCT00822328|Secondary|Modification of the Composition of the Intestinal Microflora: Escherichia Coli, Lactobacillus Spp., Lactobacillus Casei Shirota|"Fecal specimens were obtained from all 24 healthy volunteers at week 0, 1, 2, 3, 4, 5, 6.
Bacterial colonies were cultured and counted."|at week 0, 1, 2, 3, 4, 5, 6||03/2009||||
784112|NCT00822328|Primary|Modification of the Composition of the Intestinal Microflora: Bifidobacterium|Fecal specimens were obtained from all 24 healthy volunteers at week 0, 1, 2, 3, 4, 5, 6. Bifidobacterium was cultured. Bacterial colonies were counted.|week 0, 1, 2, 3, 4, 5, 6.|The number of participants for analysis was per protocol analysis.||log10 CFU/g||Standard Deviation|Log Mean
784113|NCT00822354|Primary|Raynaud's Condition Score (RCS) Visual Analog Scale (VAS)|The VAS is a 100 millimeter (mm) line where 0 mm (left boundary) represents no difficulty with Raynaud's disease, and 100 mm (right boundary) represents extreme difficulty with Raynaud's disease. The subject makes a vertical mark on the VAS to indicate difficulty experienced that day with Raynaud's disease. The RCS is the distance from the left boundary to the vertical mark in mm. Results are reported from data collected at Baseline/Week 0, Week 4, Week 5, and Week 9 visits. In subjects receiving tadalafil followed by placebo: Baseline/Week 0 data is Pre-treatment, Week 4 data corresponds to Week 4 of treatment, Week 5 data is Pre-placebo, and Week 9 data corresponds to Week 4 of placebo. In subjects receiving placebo followed by tadalafil: Baseline/Week 0 data is Pre-placebo, Week 4 data corresponds to Week 4 of placebo, Week 5 data is Pre-treatment, and Week 9 data corresponds to Week 4 of treatment.|9 weeks|Two of the ten enrolled subjects were excluded from analysis: one subject due to early withdrawal, and a second subject to avoid bias due to bilateral subclavian stent placement midway through the study.||millimeters||Full Range|Median
784253|NCT00823719|Secondary|Number of Participants With CR, as Assessed by the Investigator|CR is defined as the complete disappearance of all detectable clinical evidence of disease and disease-related symptoms.|From Day 14 (Study Day 56) to Day 21 (approximately Study Day 63) of treatment Cycle 3, or earlier in the case of early withdrawal or missing response assessment for Cycle 3|PP Population||participants|||Number
784114|NCT00822354|Secondary|Capillary Diameter|Results are reported from data collected at Baseline/Week 0, Week 4, Week 5, and Week 9 visits. In subjects receiving tadalafil followed by placebo: Baseline/Week 0 data is Pre-treatment, Week 4 data corresponds to Week 4 of treatment, Week 5 data is Pre-placebo, and Week 9 data corresponds to Week 4 of placebo. In subjects receiving placebo followed by tadalafil: Baseline/Week 0 data is Pre-placebo, Week 4 data corresponds to Week 4 of placebo, Week 5 data is Pre-treatment, and Week 9 data corresponds to Week 4 of treatment.|9 weeks|Two of the ten enrolled subjects were excluded from analysis: one subject due to early withdrawal, and a second subject to avoid bias due to bilateral subclavian stent placement midway through the study. For subject 8, Baseline/Week 0 data was used for both Pre-treatment and Pre-placebo, and Week 2 data was used for Week 4 of placebo.||micrometers||Full Range|Median
784115|NCT00822354|Secondary|Digital Blood Pressure|Results are reported from data collected at Baseline/Week 0, Week 4, Week 5, and Week 9 visits. In subjects receiving tadalafil followed by placebo: Baseline/Week 0 data is Pre-treatment, Week 4 data corresponds to Week 4 of treatment, Week 5 data is Pre-placebo, and Week 9 data corresponds to Week 4 of placebo. In subjects receiving placebo followed by tadalafil: Baseline/Week 0 data is Pre-placebo, Week 4 data corresponds to Week 4 of placebo, Week 5 data is Pre-treatment, and Week 9 data corresponds to Week 4 of treatment.|9 weeks|Two of the ten enrolled subjects were excluded from analysis: one subject due to early withdrawal, and a second subject to avoid bias due to bilateral subclavian stent placement midway through the study. For subject 10, Week 2 data was used for Week 4 of placebo because digital blood pressure data was not obtained at the Week 4 visit.||mm Hg||Full Range|Median
784116|NCT00822354|Primary|Raynaud Severity Visual Analog Score (VAS)|The VAS is a 100 millimeter (mm) line where 0 mm (left boundary) represents Raynaud's disease of low severity, and 100 mm (right boundary) represents extremely severe Raynaud's disease. The subject makes a vertical mark on the VAS to indicate the severity of Raynaud's disease over the past two weeks. The Raynaud's severity score is the distance from the left boundary to the vertical mark in mm. Results are reported from data collected at Baseline/Week 0, Week 4, Week 5, and Week 9 visits. In subjects receiving tadalafil followed by placebo: Baseline/Week 0 data is Pre-treatment, Week 4 data corresponds to Week 4 of treatment, Week 5 data is Pre-placebo, and Week 9 data corresponds to Week 4 of placebo. In subjects receiving placebo followed by tadalafil: Baseline/Week 0 data is Pre-placebo, Week 4 data corresponds to Week 4 of placebo, Week 5 data is Pre-treatment, and Week 9 data corresponds to Week 4 of treatment.|9 weeks|Two of the ten enrolled subjects were excluded from analysis: one subject due to early withdrawal, and a second subject to avoid bias due to bilateral subclavian stent placement midway through the study.||millimeters||Full Range|Median
784117|NCT00822354|Primary|Duration of Raynaud's Phenomenon Attacks|Subjects kept a daily record of the number of Raynaud's phenomenon attacks they experienced per day and the duration of each attack. Results are reported from data collected at Baseline/Week 0, Week 4, Week 5, and Week 9 visits. In subjects receiving tadalafil followed by placebo: Baseline/Week 0 data is Pre-treatment, Week 4 data corresponds to Week 4 of treatment, Week 5 data is Pre-placebo, and Week 9 data corresponds to Week 4 of placebo. In subjects receiving placebo followed by tadalafil: Baseline/Week 0 data is Pre-placebo, Week 4 data corresponds to Week 4 of placebo, Week 5 data is Pre-treatment, and Week 9 data corresponds to Week 4 of treatment.|9 weeks|Two of the ten enrolled subjects were excluded from analysis: one subject due to early withdrawal, and a second subject to avoid bias due to bilateral subclavian stent placement midway through the study. For subject 2, Week 5 data was used for both Pre-treatment and Pre-placebo because Baseline/Week 0 visit data was not obtained.||minutes||Full Range|Median
784118|NCT00822354|Primary|Number of Raynaud's Phenomenon Attacks Per Day|Subjects kept a daily record of the number of Raynaud's phenomenon attacks they experienced per day. Results are reported from data collected at Baseline/Week 0, Week 4, Week 5, and Week 9 visits. In subjects receiving tadalafil followed by placebo: Baseline/Week 0 data is Pre-treatment, Week 4 data corresponds to Week 4 of treatment, Week 5 data is Pre-placebo, and Week 9 data corresponds to Week 4 of placebo. In subjects receiving placebo followed by tadalafil: Baseline/Week 0 data is Pre-placebo, Week 4 data corresponds to Week 4 of placebo, Week 5 data is Pre-treatment, and Week 9 data corresponds to Week 4 of treatment.|9 weeks|Two of the ten enrolled subjects were excluded from analysis: one subject due to early withdrawal, and a second subject to avoid bias due to bilateral subclavian stent placement midway through the study. For subject 2, Week 5 data was used for both Pre-treatment and Pre-placebo because Baseline/Week 0 visit data was not obtained.||Raynaud's attacks per day||Full Range|Median
784119|NCT00822510|Primary|Spiritual Well Being|Measures if spiritual beliefs using a 7-item scale that ranges from 7-70. Higher score equals greater spiritual wellbeing.|3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks)|||units on scale||Standard Deviation|Mean
784120|NCT00822510|Primary|Social Well Being|Measures social well-being using the 9 item Social Well-being scale, ranging from 9-90. Higher score indicates increased social well-being.|3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks)|||units on scale||Standard Deviation|Mean
784121|NCT00822510|Primary|Multidimensional Fatigue Inventory|Measure of physical well-being, specifically fatigue, using the Multidimensional Fatigue Scale. Scores range from 0-80 with higher scores indicative of more fatigue.|3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks)|||units on scale||Standard Deviation|Mean
784122|NCT00822510|Primary|Negative Affect|Positive and Negative Affect Scale is a 20 item scale that measures positive and negative affect subscales. Scores range from 10-50 on each subscale with higher score indicating more positive affect.|3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks)|||units on scale||Standard Deviation|Mean
784123|NCT00822510|Primary|Positive Affect|Positive and Negative Affect Scale is a 20 item scale that measures positive and negative affect subscales. Scores range from 10-50 on each subscale with higher score indicating more positive affect.|3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks)|||units on scale||Standard Deviation|Mean
784124|NCT00822510|Primary|Perceived Stress|Perceived stress scale is a 10-item scale with a range of 0-40. Higher scores indicate more stress.|3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks)|||units on scale||Standard Deviation|Mean
784604|NCT00826267|Primary|Objective Response (OR)|Objective response (complete or partial) was assessed according to RECIST 1.0 criteria.|Tumour assessments were performed at screening, day 22 and day 43.|Treated set (TS). TS consisted of all patients who received at least one dose of study medication.||Percentage of participants||95% Confidence Interval|Number
784125|NCT00822510|Primary|Center for Epidemiological Studies-Depression Scale|Depression was measured by the 20-item Center for Epidemiological Studies-Depression (CES-D) scale, Range is 0-60. Scores are added together with higher score greater depression.|3 points in time, baseline, T2=T1+8 weeks, T3=T2 plus 8 weeks|Badger, T.A., Segrin, C., Figueredo, A.J., Harrington, J., Sheppard, K., Passalacqua, S., Pasvogel, A., & Bishop, M. (2011) Psychosocial Interventions to Improve Quality of Life in Prostate Cancer Survivors and their Intimate or Family Partners. Quality of Life Research. 20 (6), 833-844 [epub Dec 2010]. PMID: 21170682; PMCID: PMC3117079||units on scale||Standard Deviation|Mean
784126|NCT00822523|Secondary|"Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 200 ms Window)."|"Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in an inactive location at the ipsilateral medial malleolus after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Mean Rectified Voltage with 200 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used."|Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement|Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements.||percent change from baseline||Standard Deviation|Mean
784127|NCT00822523|Secondary|"Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 500 ms Window)."|"Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in an inactive location at the ipsilateral medial malleolus after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Mean Rectified Voltage with 500 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used."|Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement|Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements.||percent change from baseline||Standard Deviation|Mean
784128|NCT00822523|Secondary|"Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 1000 ms Window)."|"Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in an inactive location at the ipsilateral medial malleolus after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Mean Rectified Voltage with 1000 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used."|Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement|Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements.||percent change from baseline||Standard Deviation|Mean
784129|NCT00822523|Secondary|"Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 200 ms Window)."|"Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in an inactive location at the ipsilateral medial malleolus after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Root Mean Squared with 200 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used."|Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement|Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements.||percent change from baseline||Standard Deviation|Mean
784142|NCT00822523|Primary|"Change in Measured Force (Change From Baseline) (Using Strain Gauges) of Dorsiflexion of Digits 2 and 3 (Force of EDB) After vs. Before Botulinum Toxin Injection Into EDB"|The force of dorsiflexion of the combination of digits 2 and 3 (at the same time using a single loop) of the foot were measured using a strain gauge after and before the administration of Botulinum Neurotoxin type A (BoNT/A) or placebo. The baseline value was the mean of the 3 values for force obtained prior to injection of BoNT/A. The baseline was compared with the subsequent values.|Baseline (3 times) then following single injection of botulinum toxin into EDB with testing at Day 1, Day 2, Day 4, Day 14, Day 21, and Month 4|||kg||Standard Deviation|Mean
784240|NCT00823719|Secondary|Number of Participants With the Indicated AEs Associated With Decreased Hemoglobin Counts|Anaemia is defined as a pathological deficiency in the oxygen-carrying component of the blood, measured in unit volume concentrations of hemoglobin, red blood-cell volume, or red blood-cell number. Pancytopenia is defined as inadequate blood-cell formation by bone marrow, resulting in a lack of all blood-cell types.|Study Day 1 to approximately Study Day 63|Safety Population||participants|||Number
784130|NCT00822523|Secondary|"Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 500 ms Window)."|"Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in an inactive location at the ipsilateral medial malleolus after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Root Mean Squared with 500 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used."|Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement|Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements.||percent change from baseline||Standard Deviation|Mean
784131|NCT00822523|Secondary|"Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 1000 ms Window)."|"Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in an inactive location at the ipsilateral medial malleolus after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Root Mean Squared with 1000 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used."|Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement|Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements.||percent change from baseline||Standard Deviation|Mean
784132|NCT00822523|Secondary|Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 200 ms Window).|Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in the standard location at the base of the ipsilateral 5th toe after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Mean Rectified Voltage with 200 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used.|Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement|Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements.||percent change from baseline||Standard Deviation|Mean
784133|NCT00822523|Secondary|Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 500 ms Window).|Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in the standard location at the base of the ipsilateral 5th toe after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Mean Rectified Voltage with 500 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used.|Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement|Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements.||percent change from baseline||Standard Deviation|Mean
784134|NCT00822523|Secondary|Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 1000 ms Window).|Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in the standard location at the base of the ipsilateral 5th toe after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Mean Rectified Voltage with 1000 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used.|Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement|Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements.||percent change from baseline||Standard Deviation|Mean
784158|NCT00822900|Secondary|Potentially Associated Adverse Events: Deep Venous Thrombosis (DVT)|DVT - Events were defined based on a positive Doppler ultrasound exam|within 6 months|||participants|||Number
784159|NCT00822900|Secondary|Potentially Associated Adverse Events: Acute Ischemic Stroke|Acute ischemic stroke - Events were defined based on either positive computed tomography (CT) scanning, magnetic resonance imaging (MRI), or neurologist diagnosis of cerebrovascular accident (CVA)|within 6 months|||participants|||Number
784135|NCT00822523|Secondary|Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 200 ms Window).|Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in the standard location at the base of the ipsilateral 5th toe after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Root Mean Squared with 200 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used.|Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement|Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements.||percent change from baseline||Standard Deviation|Mean
784136|NCT00822523|Secondary|Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 500 ms Window).|Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in the standard location at the base of the ipsilateral 5th toe after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Root Mean Squared with 500 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used.|Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement|Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements.||percent change from baseline||Standard Deviation|Mean
784137|NCT00822523|Secondary|Percent Change of the Surface Electromyogram (SEMG) MRV-500 From EDB After vs. Before Botulinum Toxin Injection Into EDB.|Measure the percent change of the Surface Electromyogram (SEMG) as measured by the Mean Rectified Voltage (MRV) with a window of 500 ms from extensor digitorum brevis (EDB) with the reference electrode in the standard location at the base of the ipsilateral 5th toe after injection of BoNT/A into EDB compared with before injection of BoNT/A or placebo. Each MRV represents the mean of 3 individual measurements of the MRV at that timepoint with measurements at least 60 seconds apart. In order to facilitate comparison from one subject to the next, the MRV is then converted into percent change from baseline for that subject.|Baseline (mean of 3 measurement on the same day of testing) then following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4|||percent change from baseline||Standard Deviation|Mean
784138|NCT00822523|Secondary|Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 1000 ms Window).|Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in the standard location at the base of the ipsilateral 5th toe after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Root Mean Squared with 1000 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used.|Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement|Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements.||percent change from baseline||Standard Deviation|Mean
784139|NCT00822523|Secondary|Number of Participants With Serious Adverse Effects to onabotulinumtoxinA (Botulinum Type A Neurotoxin)||At each visit for nerve conduction studies following injection of onabotulinumtoxinA (botulinum type A neurotoxin) into EDB (Day 0; Day 4; Day 14; Month 4)|||participants|||Number
784140|NCT00822523|Secondary|Difference in Force From Day 14 to Day 21|The force of dorsiflexion of the combination of digits 2 and 3 (at the same time using a single loop) of the foot were measured using a strain gauge after and before the administration of Botulinum Neurotoxin type A (BoNT/A). The force at each day of testing was the mean of the 3 values for force obtained on that day. Value is percent change from baseline. Comparison is made between the percent change from baseline force and the force on Day 14 in each group vs. the percent change from baseline force and the force on Day 21 in each group.|Force measured at Day 14 after BoNT/A injction into EDB and Force measured at Day 21 after BoNT/A injction into EDB.|||percent change from baseline||Standard Deviation|Mean
784141|NCT00822523|Secondary|Stability of Baseline Measurements of Force|The force of dorsiflexion of the combination of digits 2 and 3 (at the same time using a single loop) of the foot were measured using a strain gauge on three different days prior to injection of BoNT/A or placebo. On each of the three days of baseline testing, the force was defined as the mean of three different measurements, separated by at least 1 minute from another measurement.|Baseline 1 (mean of 3 measurement on the same day of testing) compared with Baseline 2 (mean of 3 measurement on the same day of testing) on a second day compared with Baseline 3 (mean of 3 measurement on the same day of testing)|Normal controls at baseline before BoNT/A injected||kg||Standard Deviation|Mean
784160|NCT00822900|Secondary|Potentially Associated Adverse Events: Pulmonary Embolism|Pulmonary embolism - Events were defined based on either positive chest computed tomography (CT) scanning or ventilation/perfusion lung scan (V/Q).|within 6 months|||participants|||Number
784161|NCT00822900|Secondary|Potentially Associated Adverse Events: Phlebitis/Thrombophlebitis|Phlebitis/Thrombophlebitis (not due to infiltration or misplacement of the IV)|within 6 months|||participants|||Number
784143|NCT00822588|Primary|Number of Participants in Need for Bank Blood Transfusion|"Bank blood transfusions were given in both groups after assessment of independent assessor, by using a transfusion trigger. All transfusions were recorded in a transfusion log and summarized at discharge. The total number of patients per group in need for any bank blood transfusion was compared.
The participant were followed for the duration of hospital stay, an average of 6 days (SD 3 days)"|At discharge|Per protocol group. Major protocol deviations were excluded: Incorrect treatment, no treatment or exclusion criteria fulfilled.||Participants|||Number
784144|NCT00822679|Secondary|Changes in Objective and Subjective Measures of Sleep||4 days||||||
784145|NCT00822679|Primary|Changes in Circulating Inflammatory Cytokines (Interleukin [IL]-1B, IL-6, IL-10, and Tumor Necrosis Alpha [TNF-α]) and Pro-coagulant Mediators (Soluble P-selectin and CD40 Ligand).|Not performed. Zero subjects were randomized. Many potential participants screen-failed.|2 days|Not performed. Zero subjects were randomized. Many potential participants screen-failed.|||||
784146|NCT00822692|Primary|Recurrence Rates of Abscesses|Number of patient with a new abscess in same or different location as previous lesion|30 days after incision and drainage|||participants|||Number
784147|NCT00822757|Other Pre-specified|GMFR in Antibody Concentration From Baseline|An assessment of the kinetics of the immune response in the V710 group over time from baseline measurement and all postvaccination time points (Days 10, 14, 28, and 84). The calculation of GMFR is based on the ratio of IgG Titers (geometric mean concentrations in which the units of measure are µg/mL) pre/all (10, 14, 28, and 84) days postvac.|Prevaccination to Days 10, 14, 28, and 84 postvaccination|||Ratio||95% Confidence Interval|Geometric Mean
784148|NCT00822757|Other Pre-specified|GMFR by Age|Participants whose geometric mean fold–rise (GMFR) in anti-0657n IgG was measured among two age groups (18 to 59 years of age and 60 to 70 years of age)14 days after a single dose of the lyophilized formulation of V710 (60 Mcg) by a LUMINEX™ assay for IgG antibodies directly binding to the 0657nI S.aureus antigen. The calculation of GMFR is based on the ratio of IgG Titers (geometric mean concentrations in which the units of measure are µg/mL) pre/14 days postvac.|Prevaccination to 14 days postvaccination|||Ratio||95% Confidence Interval|Geometric Mean
784149|NCT00822757|Primary|Geometric Mean Fold-rise (GMFR) After the Administration of the Lyophilized Formulation of V710 (60 mcg).|Participants whose geometric mean fold–rise (GMFR) in anti-0657n IgG was measured 14 days after a single dose of the lyophilized formulation of V710 (60 mcg) by a LUMINEX™ assay for IgG antibodies directly binding to the 0651nI S. aureus antigen. The calculation of GMFR is based on the ratio of IgG Titers (geometric mean concentrations in which the units of measure are µg/mL) prevaccination (pre)/14 days postvaccination (postvac).|Prevaccination to 14 days postvaccination|||Ratio||95% Confidence Interval|Geometric Mean
784150|NCT00822770|Secondary|Response Rate (Engraftment Versus Graft Failure)|Engraftment: first day of three (3) consecutive days that Absolute neutrophil count (ANC) exceeds 0.5 X 109/L. Subsequent chimerism studies must demonstrate the presence of donor derived cells. Graft Failure: failure to achieve an ANC >0.5 X 109/L for 3 consecutive days within 28 days after transplantation or a decline of ANC <0.5 x 109/L for three consecutive days after initial documented engraftment unless this is correlated with progression / recurrence of the underlying malignancy.|100 Days post engraftment||||||
784151|NCT00822770|Secondary|Time to Failure|Time to treatment failure defined as either disease recurrence or death, measured in months.|Baseline till disease progression/death, up to 1 year.||||||
784152|NCT00822770|Primary|Maximum Tolerated Dose (MTD) Plerixafor|MTD dose of Plerixafor in combination with a fixed dose of Filgrastim where dose limiting toxicity defined as any grade 4 non-hematologic toxicity observed within 28 days from Day 0 (day of transplant).|28 day cycle (Plerixafor Day -7 to Day -4)|||mg/kg|||Number
784153|NCT00822900|Secondary|Potentially Associated Adverse Events: Myocardial Infarction (MI)|Myocardial infarction - Events were defined based on serial cardiac enzyme elevation consistent with MI and/or new ST elevation on electrocardiogram (ECG) consistent with MI. Potentially associated adverse events (those events which are included as outcome measures) were specifically defined per the protocol, and the classification of an event as a PAAE was determined by the site. The reported name of the associated event, however, was subject to clinical judgement and case details; these were then further coded by the Principal Investigator. Since these data points do not share the same definition, there is no reason to expect perfect concordance. (For example, the potentially associated adverse event of myocardial infarction may include MedDRA codes other than myocardial infarction.)|within 6 months|||participants|||Number
784154|NCT00822900|Secondary|Potentially Associated Adverse Events: Central Nervous System (CNS) Infection|CNS infection - Events must have met Centers for Disease Control and Prevention (CDC) definition of CNS infection. The definition includes intracranial infection, Meningitis, ventriculitis, and spinal abscess without meningitis.|within 6 months|||participants|||Number
784155|NCT00822900|Secondary|Potentially Associated Adverse Events: Pneumonia|Events must have met Centers for Disease Control and Prevention (CDC) definition of pneumonia. There are three specific types of pneumonia: clinically defined pneumonia, pneumonia with specific laboratory findings, and pneumonia in immunocompromised patients. There are specific algorithms to identify each pneumonia, which include x-ray findings, fever with no other cause, leukopenia or leukocytosis, altered mental status with no other cause (adults >70 years old), new onset of purulent sputum, change in character of sputum, increase respiratory secretions, increase suctioning requirements, new onset or worsening cough, dyspnea, tachypnea, rales, bronchial breath sounds, or worsening gas exchange, increased oxygen requirements, or increased ventilator demand). Also, labs can identify pneumonia such as positive growth in blood culture, positive Gram stain, and histopathologic exam evidence.|within 6 months|||participants|||Number
784156|NCT00822900|Secondary|Potentially Associated Adverse Events: Sepsis|Sepsis - Events must have met Centers for Disease Control and Prevention (CDC) definition of sepsis. The definition includes that a patient ≤1 year of age has at least 1 of the following clinical signs or symptoms with no other recognized cause: fever (>38°C rectal), hypothermia (<37°C rectal), apnea, or bradycardia, and blood culture not done or no organisms detected in blood and no apparent infection at another site and physician institutes treatment for sepsis.|within 6 months|||participants|||Number
784157|NCT00822900|Secondary|Potentially Associated Adverse Events: Unexplained Increased Liver-enzyme Level|Unexplained increased liver enzymes (e.g. not due to liver injury ) - Events were defined based on aspartate transaminase (AST) and alanine transaminase (ALT) levels > 500 U/L and/or total bilirubin levels > 2.0 mg/dL.|within 6 months|||participants|||Number
784164|NCT00822900|Primary|Favorable Outcome as Determined by the Glasgow Outcome Scale-Extended (GOSE)|A measure of functional recovery: A GOS-E score of 1 indicates death, 2 indicates a vegetative state, 3 or 4 indicates severe disability, 5 or 6 indicates moderate disability, and 7 or 8 indicates good recovery. Favorable outcome was defined via stratified dichotomy based on the severity of the initial injury. For subjects with a severe injury, a GOS-E of 3 or higher were considered to be a favorable outcome; for subjects with moderate-to-severe injury, a GOS-E of 5 or higher was considered to be a favorable outcome; for subjects with a moderate injury, a GOS-E of 7 or higher was considered to be a favorable outcome.|6 months post randomization|The primary analysis was conducted according to intention to treat.||participants|||Number
784165|NCT00822926|Secondary|NRS Score Three Weeks After Injection|Pain scores were measured at baseline, 3 weeks after placebo, and 3 weeks after botox. Scores range from 0 (no pain) to 10 (severe, disabling pain).|3 weeks after injection|A total of 3 participants completed the study (1 received Placebo first then Botox, 2 received Botox first then Placebo). Each of those 3 participants received both Placebo and Botox, as represented in the overall number of participants analyzed for both treatments.||Units on a scale||Standard Deviation|Mean
784166|NCT00822926|Secondary|Improvement in Psychosocial Function as Assessed by Outcomes as Dictated by the IMMPACT Guidelines|The Beck Depression Inventory was used to assess psychosocial function. Scores were measured at baseline, their final questionnaire following the first injection visit, and their final questionnaire following their second injection visit. Scores range from 0-63, with lower scores representing less severe depression symptoms and higher scores representing more severe depression symptoms.|Duration of trial (2-20 months, depending on how long pain relief lasts)|A total of 3 participants completed the study (1 received Placebo first then Botox, 2 received Botox first then Placebo). Each of those 3 participants received both Placebo and Botox, as represented in the overall number of participants analyzed for both treatments.||Units on a scale||Standard Deviation|Mean
784167|NCT00822926|Primary|Time to Analgesic Failure|Participants completed the Pain Numeric Rating Scale everyday after the injections. Outcome measure represents the number of days before pain returned to baseline levels.|Duration of trial (2-20 months, depending on how long pain relief lasts)|A total of 3 participants completed the study (1 received Placebo first then Botox, 2 received Botox first then Placebo). Each of those 3 participants received both Placebo and Botox, as represented in the overall number of participants analyzed for both treatments.||days||Standard Deviation|Mean
784168|NCT00823043|Primary|Subject Reported Blurred Vision|Subjects reported their vision was blurred after they put the drops in their eyes using the following scale: 0=never, 1=rarely, 2=sometimes, 3=frequently, 4=always.|Upon instillation|||Units on a Scale||Standard Deviation|Mean
784169|NCT00823043|Primary|Subject Reported Light Sensitivity|Subjects reported light hurt their eyes after they put the drops in their eyes using the following scale: 0=never, 1=rarely, 2=sometimes, 3=frequently, 4=always.|Upon instillation|Analysis includes all subjects that answered this question. One subject from each arm did not answer this question.||Units on a Scale||Standard Deviation|Mean
784170|NCT00823043|Primary|Subject Reported Tearing|Subjects reported tearing after they put the drops in their eyes using the following scale:0=never, 1=rarely, 2=sometimes, 3=frequently, 4=always.|Upon instillation.|||Units on a Scale||Standard Deviation|Mean
784171|NCT00823043|Primary|Subject Reported Burning/Stinging|Subjects reported burning/stinging after they put the drops in their eyes using the following scale: 0=never, 1=rarely, 2=sometimes, 3=frequently, 4=always.|Upon instillation|||Units on a Scale||Standard Deviation|Mean
784172|NCT00823069|Secondary|Number of Subjects Showing Wrinkle Improvement at Day 14|This measure was performed by the validated GAIS tool (Global Asthetic Improvement Scale). The GAIS was completed by the participant at day 14. The GAIS is a qualitative 5 point scale evaluating Aesthetic Improvement (0=worse, 1=no change, 2=Improved, 3=Much Improved, 4=very much improved). Treatment success is defined as at least a one grade improvement (2, 3, or 4) from pre-treatment.|14 days after treatment when compared to baseline|||Participants|||Number
784173|NCT00823069|Primary|Treatment Difference in VAS (Perlane Side - Perlane-L Side) With Difference in VAS >= 10 mm||After Injection on Day of Treatment|This is a split-face design. Perlane and Perlane with Lidocaine was applied to different sides of the subject's face. A total of 60 subjects received both products. The study evaluated which side of the face has less pain, as measured by the Visual Analogue Scale (VAS). Least pain on VAS scale is at 0 mm mark and worst pain is 100 mm mark.||Participants||95% Confidence Interval|Number
784174|NCT00823082|Secondary|Length of Hospital Stay|Length of hospital stay (days) in both groups was defined as the discharge date minus the surgery date plus 1 day, during a maximum of 70 days after ICU admission.|During ICU stay (maximum 70 days)|||days||Inter-Quartile Range|Median
784175|NCT00823082|Secondary|Mechanical Ventilation Duration||During ICU stay (maximum 70 days)|Intent-to-treat set||Days||Inter-Quartile Range|Median
784176|NCT00823082|Secondary|Percentage of Subjects With Renal Dysfunction|Percentage of subjects with renal dysfunction defined as an increase of serum creatinine levels to >2.0 and twice the baseline level or need for renal replacement therapy|During ICU stay (maximum 70 days)|Intent-to-treat set||Percentage of participants|||Number
784177|NCT00823082|Secondary|Percentage of Subjects With Low Cardiac Syndrome|Percentage of subjects with low cardiac syndrome defined as the need for major inotropic support or intra-aortic balloon pump|During ICU stay (maximum 70 days)|Intent-to-treat set. Three subjects in the Antithrombin III treatment group and 1 subject in the Control group were missing this data.||percentage of participants|||Number
784178|NCT00823082|Secondary|Percentage of Subjects Needing Surgical Re-exploration|Percentage of subjects needing surgical re-exploration resulting from bleeding|During ICU stay (maximum 70 days)|Intent-to-treat set. Two subjects in the Antithrombin III treatment group and 2 subjects in the Control group were missing this data.||percentage of participants|||Number
784179|NCT00823082|Secondary|Need for Blood Products|Number of units of packed red blood cells, fresh frozen plasma, and/or platelets needed|During ICU stay (maximum 70 days)|Intent-to-treat set||Units||Standard Error|Least Squares Mean
784180|NCT00823082|Secondary|Postoperative Blood Loss in First 12 Hours|Blood loss defined as the amount of blood collected in the cardiotomy reservoir from ICU admission through the following 12 hours|ICU admission through 12 hours post-operative|Intent-to-treat set. One subject in the Antithrombin III treatment group was missing this data.||mL||Standard Error|Least Squares Mean
784181|NCT00823082|Secondary|Heparin Resistance|Percentage of subjects with heparin resistance defined as failure to reach an activated clotting time >450 seconds after a dose of up to 400 IU/kg of heparin, or failure to maintain this activated clotting time value despite heparin supplementations of 100 IU/kg per each dose with an interval of at least 30 minutes between doses|Immediately after anesthesia induction|Intent-to-treat set. One subject in the Antithrombin III treatment group was missing this data.||percentage of participants|||Number
784182|NCT00823082|Secondary|In-hospital Postoperative Mortality||70 days after ICU admission (maximum)|Intent-to-treat set. One subject in the control group was missing this data.||percentage of participants|||Number
784183|NCT00823082|Secondary|ICU Stay Duration||During ICU stay (maximum 70 days)|Intent-to-treat set. One subject in the control group was missing this data.||days||Inter-Quartile Range|Median
784184|NCT00823082|Secondary|Percentage of Patients With Thromboembolic Events|Percentage of subjects with thromboembolic events defined as perioperative myocardial infarction, stroke, mesenteric infarction, peripheral thromboembolism and pulmonary embolism|During ICU stay (maximum 70 days)|Intent-to-treat set||percentage of participants|||Number
784185|NCT00823082|Secondary|Percentage of Subjects With Adverse Neurologic Outcome|Percentage of subjects with adverse neurologic outcome defined as: coma, stroke or psychotic behaviors lasting >12 hours after extubation|During ICU stay (maximum 70 days)|Intent-to-treat set||percentage of participants|||Number
784186|NCT00823082|Secondary|Percentage of Subjects With Postoperative Myocardial Infarction|Percentage of subjects with postoperative myocardial infarction defined through enzymatic criteria plus new Q-waves at the electrocardiogram|During ICU stay (maximum 70 days)|Intent-to-treat set||percentage of participants|||Number
784187|NCT00823082|Primary|Percentage of Subjects With ATIII Levels of 58% or Higher at ICU Admission|Percentage of subjects with ATIII levels of 58% functional activity or higher at ICU admission|ICU admission|Intent-to treat set and Per-protocol set||percentage of participants|||Number
784188|NCT00823082|Primary|Postoperative ATIII Levels at the ICU Admission|Measurement of postoperative ATIII functional activity at ICU admission|ICU admission|Intent-to-treat set and Per-protocol set||IU||Standard Deviation|Mean
784189|NCT00823095|Secondary|The Secondary Endpoint Measure is a Reduction on Wound Size.|reduction in bioburden as assessed by number of cfu's per cm2 on culture|28 days post enrollment|Data not available for this study due to dissolution of company contracted to perform analysis.|||||
784190|NCT00823095|Primary|The Primary Endpoint is the Eradication of the Bio-burden as Measured by a Reduction in Culture Growth to ≤ +2.||at 28 days post enrollment|Data not available for this study due to dissolution of company contracted to perform study analysis|||||
784191|NCT00823199|Post-Hoc|Uric Acid Level||Baseline to 4 weeks|2 subjects had missing data||mg/dL||Standard Deviation|Mean
784192|NCT00823199|Secondary|Simpson Angus Scale for Parkinsonism|Measures drug induced parkinsonism, score 0 (best, no Parkinsonism) to 36 (worst)|baseline and 4 weeks|||score on scale||Standard Deviation|Mean
784193|NCT00823199|Primary|Change in Positive and Negative Syndrome Scale (PANSS) Measures Symptoms of Schizophrenia|Symptom scale Score 30 (best, no symptoms of schizophrenia) to 210 (worst)|baseline and 4 weeks|Two subjects withdrew before the first week's evaluation||scores on a scale||Standard Deviation|Mean
784194|NCT00823212|Secondary|Acute Technical Success|Defined as successful delivery and deployment of the study stent to the target vessel, without balloon rupture or stent embolization; expressed per stent|Acute-At time of index procedure|Analysis was intention to treat (all patients in the study).||percentage of stents|Stents||Number
784195|NCT00823212|Secondary|Clinical Procedural Success|Defined as mean lesion diameter stenosis <30% with visually assessed TIMI 3 flow and without the occurrence of in-hospital myocardial infarction (MI), target vessel revascularization (TVR), or cardiac death|In hospital|Analysis was intention to treat (all patients in study).||percentage of participants|||Number
784196|NCT00823212|Secondary|Composite of All Death, All Myocardial Infarction (MI), All Target Vessel Revascularization (TVR)|See above for definitions of MI and TVR.|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
784197|NCT00823212|Secondary|Composite of All Death, All Myocardial Infarction (MI), All Target Vessel Revascularization (TVR)|See above for definitions of MI and TVR.|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
784198|NCT00823212|Secondary|Composite of All Death, All Myocardial Infarction (MI), All Target Vessel Revascularization (TVR)|See above for definitions of MI and TVR|30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
784199|NCT00823212|Secondary|Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days).|>30 days-1 year|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
784200|NCT00823212|Secondary|Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days).|>24 hr-30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
784201|NCT00823212|Secondary|Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days).|24 hours|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
784202|NCT00823212|Secondary|Target Vessel Revascularization (TVR)|TVR is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
784203|NCT00823212|Secondary|Target Vessel Revascularization (TVR)|TVR is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
784204|NCT00823212|Secondary|Target Vessel Revascularization (TVR)|Target vessel revascularization is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.|30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
784205|NCT00823212|Secondary|Target Lesion Revascularization (TLR)|TLR is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
784206|NCT00823212|Secondary|Target Lesion Revascularization (TLR)|TLR is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
784207|NCT00823212|Secondary|Target Lesion Revascularization (TLR)|Target lesion revascularization is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.|30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
784208|NCT00823212|Secondary|All Death or Myocardial Infarction (MI)|Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) >3x normal (peri-percutaneous coronary intervention [PCI]) or >2x normal (spontaneous) with elevated CK-MB, or troponin >3x normal (peri-PCI) or >2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin >5x normal|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
784209|NCT00823212|Secondary|All Death or Myocardial Infarction (MI)|Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) >3x normal (peri-percutaneous coronary intervention [PCI]) or >2x normal (spontaneous) with elevated CK-MB, or troponin >3x normal (peri-PCI) or >2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin >5x normal|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
784210|NCT00823212|Secondary|All Death or Myocardial Infarction (MI)|Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) >3x normal (peri-percutaneous coronary intervention [PCI]) or >2x normal (spontaneous) with elevated CK-MB, or troponin >3x normal (peri-PCI) or >2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin >5x normal|30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
784211|NCT00823212|Secondary|Cardiac Death or Myocardial Infarction (MI)|Cardiac death is defined as Death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded; see definition of MI above|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
784615|NCT00826540|Secondary|Feasibility of Study Treatment|Will be evaluated based on the number of patients who are able to > tolerate the regimen, how long they tolerate it and whether they elect to stop treatment.|Up to 2 years||||||
784212|NCT00823212|Secondary|Cardiac Death or Myocardial Infarction (MI)|Cardiac death is defined as death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded; see definition of MI above|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
784213|NCT00823212|Secondary|Cardiac Death or Myocardial Infarction (MI)|Cardiac death is defined as death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded; see definition of MI above|30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
784214|NCT00823212|Secondary|Non-cardiac Death|Defined as a death not due to cardiac causes (see definition of cardiac death above)|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
784215|NCT00823212|Secondary|Non-cardiac Death|Defined as a death not due to cardiac causes (see definition of cardiac death above)|6 Months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
784216|NCT00823212|Secondary|Non-cardiac Death|Defined as a death not due to cardiac causes (see definition of cardiac death above)|30 Days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
784217|NCT00823212|Secondary|Cardiac Death Related to the Target Vessel|Cardiac death is defined as Death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
784218|NCT00823212|Secondary|Cardiac Death Related to the Target Vessel|Cardiac death is defined as Death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
784219|NCT00823212|Secondary|Cardiac Death Related to the Target Vessel|Cardiac death is defined as Death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded|30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
784220|NCT00823212|Secondary|All Cause Mortality||12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
784221|NCT00823212|Secondary|All Cause Mortality||6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
784222|NCT00823212|Secondary|All Cause Mortality||30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of patients|||Number
784223|NCT00823212|Secondary|Myocardial Infarction (MI) Related to the Target Vessel|Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) >3x normal (peri-percutaneous coronary intervention [PCI]) or >2x normal (spontaneous) with elevated CK-MB, or troponin >3x normal (peri-PCI) or >2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin >5x normal|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
784224|NCT00823212|Secondary|Myocardial Infarction (MI) Related to the Target Vessel|Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) >3x normal (peri-percutaneous coronary intervention [PCI]) or >2x normal (spontaneous) with elevated CK-MB, or troponin >3x normal (peri-PCI) or >2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin >5x normal|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
784241|NCT00823719|Secondary|Number of Participants With the Indicated Adverse Events (AEs) Associated With Neutropenia|Neutropenia is defined as an abnormal decrease in the number of neutrophils (type of white blood cell in blood) in the blood. Febrile neutropenia is the development of fever in participants with neutropenia. Pancytopenia is defined as inadequate blood-cell formation by bone marrow, resulting in a lack of all blood-cell types.|Study Day 1 to approximately Study Day 63|Safety Population||participants|||Number
784225|NCT00823212|Secondary|Myocardial Infarction (MI) Related to the Target Vessel|Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) >3x normal (peri-percutaneous coronary intervention [PCI]) or >2x normal (spontaneous) with elevated CK-MB, or troponin >3x normal (peri-PCI) or >2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin >5x normal|30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
784226|NCT00823212|Secondary|Target Vessel Failure (TVF)|TVF is defined as any ischemia-driven revascularization of the target vessel, MI (Q-wave and non–Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
784227|NCT00823212|Secondary|Target Vessel Failure (TVF)|TVF is defined as any ischemia-driven revascularization of the target vessel, MI (Q-wave and non–Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
784228|NCT00823212|Secondary|Target Vessel Failure (TVF)|TVF is defined as any ischemia-driven revascularization of the target vessel, MI (Q-wave and non–Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.|30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
784229|NCT00823212|Secondary|Target Lesion Failure (TLF)|TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non–Q-wave) related to the target vessel, or cardiac death related to the target vessel.|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
784230|NCT00823212|Secondary|Target Lesion Failure (TLF)|TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non–Q-wave) related to the target vessel, or cardiac death related to the target vessel.|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
784231|NCT00823212|Secondary|Target Lesion Failure (TLF)|TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non–Q-wave) related to the target vessel, or cardiac death related to the target vessel.|30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||Percentage of participants|||Number
784232|NCT00823212|Primary|Target Lesion Failure (TLF)|Defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non–Q-wave) related to the target vessel, or cardiac death related to the target vessel.|12-month post index procedure|The primary analysis set for the non-inferiority testing of the primary endpoint, 12-month TLF, is the per-protocol analysis set. All randomized participants who received their assigned treatment are included in the per-protocol analysis set.||percentage of participants|||Number
784233|NCT00823264|Primary|Time of Elimination of Phenytoin in Patients With Elevated Phenytoin Levels|We enrolled patients with elevated phenytoin levels into the study with greater than 30 ug/cc. The treatment arm received multiple doses of activated charcoal and the control arm received no activated charcoal. We obtained serum phenytoin levels every 6 hours for 24 hours then once every 24 hours. The time to reach a subtoxic level was determined in each arm by looking at serum phenytoin levels and documenting when it was below 25 ug/cc.|Serum phenytoin levels were obtained every 6 hours for 24 hours then once every 24 hours|||hours||Inter-Quartile Range|Median
784234|NCT00823303|Primary|Confirmed Hypercalcemia|Serum Calcium 10.5 mg/dL or higher, confirmed by repeat measurement.|24 week treatment period|||participants|||Number
784235|NCT00823472|Secondary|Number of Cumulus Oocyte Complexes Obtained||one year|||oocytes||Standard Deviation|Mean
784236|NCT00823472|Primary|Proportion of Top Embryos Per OPU.||1 year|ITT||percentage embryos|||Number
784237|NCT00823615|Primary|Corrected Near Binocular Visual Measurement in Normal Illumination Reported as Binocular Near Visual Acuity|Tested while reading charts at 40 cm with both eyes together in normal lighting. This outcome is measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 equates to 20/20 Snellen acuity and is considered normal. Positive logMAR values indicate poorer vision and negative values denote better visual acuity.|After 1 week of wear|Per protocol. Analysis excluded major protocol deviations as determined by masked review.||LogMAR||Standard Deviation|Mean
784238|NCT00823615|Primary|Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity|Tested while reading charts distant to the subject with both eyes together in normal lighting. This outcome is measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 equates to 20/20 Snellen acuity and is considered normal. Positive logMAR values indicate poorer vision and negative values denote better visual acuity.|After 1 week of wear|Per protocol. Analysis excluded major protocol deviations as determined by masked review.||LogMAR||Standard Deviation|Mean
784239|NCT00823719|Secondary|Number of Participants With the Indicated AEs Associated With Decreased Platelet Counts|Thrombocytopenia is defined as an abnormal decrease in the number of platelets in circulatory blood. Pancytopenia is defined as inadequate blood-cell formation by bone marrow, resulting in a lack of all blood-cell types.|Study Day 1 to approximately Study Day 63|Safety Population||participants|||Number
784616|NCT00826540|Secondary|Overall Survival|The distribution of overall survival will be estimated using Kaplan-Meier methodology.|Time from registration to death, assessed up to 2 years||||||
784242|NCT00823719|Secondary|Number of Participants Who Were Positive and Negative for Human Anti-human Antibodies (HAHA) at the Indicated Time Points|Human anti-human antibodies (HAHA) indicate immune response to the administered human monoclonal antibody in a two-step assay. A positive screening result is confirmed in a second step. Negative Conclusive is subset of Negative and is a negative HAHA test result with an ofatumumab concentration <200 µg/mL in a pharmacokinetic sample collected at the same time as the HAHA sample. Data are presented when a HAHA sample was collected. WD, withdrawal; FU, follow up.|Study Day 1 up to approximately Study Day 63|Safety Population. Data are presented for those participants who contributed a sample.||participants|||Number
784243|NCT00823719|Secondary|Volume of Distribution at Steady State (Vss) of Ofatumumab|Vss is the apparent volume of distribution when plasma concentrations are measured under steady state conditions. At steady state, the plasma concentration-time profile of the drug is similar after each dose.|Study Day 1 up to Study Day 85 (up to 12 weeks)|Pharmacokinetic Population||Liters||Geometric Coefficient of Variation|Geometric Mean
784244|NCT00823719|Secondary|Terminal Phase Half-life (t1/2) of Ofatumumab|t1/2 is defined as terminal phase half-life, which is the time required for the amount of the drug in the body to decrease by half.|Study Day 1 up to Study Day 85 (up to 12 weeks)|Pharmacokinetic Population||hr||Geometric Coefficient of Variation|Geometric Mean
784245|NCT00823719|Secondary|Trough Plasma Concentration (Ctrough) of Ofatumumab Prior to Second Infusion (Cycle 1 Day 8), Third Infusion (Cycle 2), and Last Infusion (Cycle 3)|Ctrough is defined as the trough plasma concentration, which is the measured concentration at the end of a dosing interval (taken directly before the start of the next infusion).|Cycle 1 Day 8 (Study Day 8; up to 8 hours prior to infusion start), Cycle 2 (Study Day 22; up to 7 hours prior to infusion start), Cycle 3 (Study Day 43; up to 6 hours prior to infusion start)|Pharmacokinetic Population. Data for participants who switched chemotherapy regimen are not included in the summaries by chemotherapy after the switch but are included in the total summaries. Data are provided for the number of participants attending each visit. Results are reported by first dose group and combined, as appropriate.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
784246|NCT00823719|Secondary|Maximum Plasma Concentration (Cmax) of Ofatumumab at the First Infusion (Cycle 1 Day 1), Second Infusion (Cycle 1 Day 8), and Last Infusion (Cycle 3)|Cmax is defined as the maximum concentration of drug in plasma samples for the dosing occasion.|Cycle 1 Day 1 (Study Day 1; up to 48 hours), Cycle 1 Day 8 (Study Day 8; up to 24 hours), Cycle 3 (Study Day 43; up to 48 hours)|Pharmacokinetic Population. Data for participants who switched chemotherapy regimen are not included in the summaries by chemotherapy after the switch but are included in the total summaries. Data are provided for the number of participants attending each visit. Results are reported by first dose group and combined, as appropriate.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
784247|NCT00823719|Secondary|Clearance (CL) of Ofatumumab|CL is the clearance of drug from plasma, which is defined as the volume of plasma from which drug is removed per unit time.|Study Day 1 up to Study Day 85 (up to 12 weeks)|Pharmacokinetic Population||mL/hr||Geometric Coefficient of Variation|Geometric Mean
784248|NCT00823719|Secondary|Area Under the Concentration-time Curve During the Dosing Interval (AUC(0-tau)) of Ofatumumab at the Last Infusion (Cycle 3)|AUC(0-tau) is the area under the plasma concentration-time curve from time zero (0) over the dosing interval, tau, and is a measure of drug exposure. Tau is 21 days (504 hours) in this study.|Cycle 3 (Study Day 43; 3 weeks)|Pharmacokinetic Population. Data for participants who switched chemotherapy regimen are not included in the summaries by chemotherapy after the switch but are included in the total summaries. Data are provided for the number of participants attending each visit. Results are reported by first dose group and combined, as appropriate.||µg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
784249|NCT00823719|Secondary|Area Under the Concentration-time Curve From Time Zero to Infinity, AUC(0-inf), of Ofatumumab at the First Infusion (Cycle 1, Day 1) and the Last Infusion (Cycle 3)|AUC is defined as the area under the ofatumumab (Ofa) concentration-time curve as a measure of drug exposure. AUC(0-inf) is AUC from the start of infusion extrapolated to infinite time. Results are reported by first dose group and combined, as appropriate.|Cycle 1 Day 1 (Study Day 1; up to 1 week) and Cycle 3 (Study Day 43; up to 6 weeks)|Pharmacokinetic Population: all participants (par.) exposed to ofatumumab from whom a pharmacokinetic sample was obtained and analyzed. Data for par. who switched chemotherapy regimen are not included in the summaries by chemotherapy after the switch but are included in the total summaries. Data are provided for the par. attending each visit.||µg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
784250|NCT00823719|Secondary|Overall Survival|Overall survival is defined as the interval of time between the date of treatment start and the date of death due to any cause. For participants who did not die, time of death was censored at the date of last contact.|From Day 14 (Study Day 56) to Day 21 (approximately Study Day 63) of treatment Cycle 3, or earlier in the case of early withdrawal or missing response assessment for Cycle 3|PP Population||days||95% Confidence Interval|Median
784251|NCT00823719|Secondary|Progression-free Survival (PFS)|PFS is defined as the interval of time between the date of treatment start and the earlier of the date of disease progression and the date of death due to any cause. Disease progression was based on the assessments locally by investigators for the disease under study. Disease progression was based on imaging data or clinical assessment data (if radiologic assessment data were not possible or assessment was not performed).|From Day 14 (Study Day 56) to Day 21 (approximately Study Day 63) of treatment Cycle 3, or earlier in the case of early withdrawal or missing response assessment for Cycle 3|PP Population||days||95% Confidence Interval|Median
784252|NCT00823719|Secondary|Number of Participants With the Ability to Mobilize at Least 2 Million Cluster of Differentiation (CD)34+ Cells Per Kilogram (kg) From Peripheral Blood|CD34+ cells are a mixture of stem cells and white blood cells of various degrees of maturity. Stem cell mobilization is the process of stimulating the hematopoietic stem cells (CD34+) to move out of the bone marrow and into the bloodstream, where they can be collected via a process called apheresis. Successful mobilization was defined as the collection of >2x10^6 CD34+ cells/kg. Only those participants, who commenced mobilization, following the administration of ofatumumab in combination with either ICE or DHAP combination chemotherapy, were assessed.|During treatment Cycle 2 (Study Days 22-42) and/or Cycle 3 (Study Days 43-63)|Stem Cell Mobilization Population. All participants in the PP Population in whom stem cell mobilization was attempted and CD34+ cell data are available.||participants|||Number
784254|NCT00823719|Primary|Number of Participants With Overall Response (OR), as Assessed by the Investigator|Responders with OR included participants with complete response (CR) and partial response (PR). This was based on adequate responses from the investigator assessment after the completion of treatment. CR: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms. PR: at least a 50% decrease from baseline in the sum of the product of the diameters of target lesions.|From Day 14 (Study Day 56) to Day 21 (approximately Study Day 63) of treatment Cycle 3, or earlier in the case of early withdrawal or missing response assessment for Cycle 3|Per protocol (PP) Population: all participants who received at least one dose of ofatumumab. Participants with major protocol deviations that could have impacted the efficacy outcome, and participants not exposed to ofatumumab or without CD20+ aggressive lymphoma were excluded from assessment. CD, cluster of differentiation.||participants|||Number
784255|NCT00823797|Secondary|Overall Survival|*inclusive of subjects still alive at time of last reporting.|Until death or last reported survival|||months||95% Confidence Interval|Median
784256|NCT00823797|Secondary|Toxic Death|Defined as death that is possibly, probably, or definitely attributed to bendamustine hydrochloride.|Up to 30 days after completion of study treatment|||Participants|||Count of Participants
784257|NCT00823797|Secondary|PFS|Defined as the time from date of initial therapy to first objective documentation of tumor progression or death.|Up to progression or death, whichever came first, assessed up to 108 months|||months||95% Confidence Interval|Median
784258|NCT00823797|Primary|PFS-6|Defined as the proportion of patients who remain alive and free of any disease progression at 6 months. PFS over time will be estimated using the Kaplan-Meier method with standard errors estimated using Greenwood's formula.|At 6 months|||Participants|||Count of Participants
784259|NCT00823823|Secondary|Compartment Syndrome or Neurovascular Compromise, Saw Burns and/or Lacerations|The number of participants that experienced compartment syndrome or neurovascular compromise, saw burn and/or laceration within four weeks post-randomization.|Up to 4 weeks post-randomization|All subjects who completed the four-week follow-up period with no protocol violations.||participants|||Number
784260|NCT00823823|Primary|Loss of Radius Fracture Reduction|The number of participants that experienced radiographic loss of reduction by four weeks post-randomization.|4 weeks post-randomization|All subjects who completed the four-week follow-up period with no protocol violations.||participants|||Number
784261|NCT00823836|Secondary|Percentage of Participants Remaining in the Study on the Indicated Days During the Long-term Phase in the Ropinirole PR-Ropinirole PR Group|The percentage of participants remaining in the study was presented by Kaplan-Meier method, where premature discontinuation (i.e., withdrawal before Week 54) was the event, and participants who had completed the study were censored.|0-385 days (up to Week 54)|Long-FAS. Data were evaluated only at the time point at which they had been collected.||percentage of participants|||Number
784262|NCT00823836|Secondary|"Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at Off) at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group"|"The Modified Hoehn & Yahr criteria are measured on the following 8-point scale for disease severity: 0, No signs of disease; 1, Unilateral disease; 1.5, Unilateral plus axial involvement; 2, Bilateral disease; 2.5, Mild bilateral disease; 3, Mild to moderate bilateral disease; 4, Severe disability; and 5, Wheelchair bound or bedridden unless aided. Off state is defined as the state at which PD symptoms are not adequately controlled by the drug."|Weeks 0 and 54|"Long-FAS. Only participants who had off state were included in the analysis. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis for Week 54."||participants|||Number
784263|NCT00823836|Secondary|"Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at On) at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group"|"The Modified Hoehn & Yahr criteria are measured on the following 8-point scale for disease severity: 0, No signs of disease; 1, Unilateral disease; 1.5, Unilateral plus axial involvement; 2, Bilateral disease; 2.5, Mild bilateral disease; 3, Mild to moderate bilateral disease; 4, Severe disability; and 5, Wheelchair bound or bedridden unless aided. On state is defined as the state at which PD symptoms are well controlled by the drug."|Weeks 0 and 54|Long-FAS. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis for Week 54.||participants|||Number
784264|NCT00823836|Secondary|Mean Change From Week 0 in Awake Time Spent “On” With Troublesome Dyskinesias at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group|"On state is defined as the state at which PD symptoms are well controlled by the drug. Troublesome dyskinesia is defined as dyskinesia that interferes with the participant's daily activity. Mean change from Week 0 in On time with troublesome dyskinesias (actual hours) was calculated as On time with troublesome dyskinesias (hours) at Week 54 minus On time with troublesome dyskinesias (hours) at Week 0."|Weeks 0 and 54|Long-FAS. Participants who had 0 hour as On time with troublesome dyskinesias at Week 0 were excluded from the analysis. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis.||hours||Standard Deviation|Mean
784265|NCT00823836|Secondary|Mean Change From Week 0 in Percentage of Awake Time Spent “Off” at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group|"Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Off time is measured as a proportion using the following formula: (Sum of two days off time [hours]/Sum of two days awake time [hours]) x 100. Change from Week 0 in Off time is measured using the following formula: Off time (proportion) at Week 54 minus Off time (proportion) at Week 0."|Weeks 0 and 54|Long-FAS. Participants who had 0 hour as Off time at Week 0 were excluded from the analysis. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis.||percentage of time||Standard Deviation|Mean
784339|NCT00824005|Secondary|Incidence of a Major Adverse Cardiac Event|"Incidence of major adverse cardiac events (new MI, rehospitalization for PCI in coronary artery territories that were treated, death, or rehospitalization for acute coronary syndrome and for congestive heart failure).
(Incidence rate)"|Measured at Baseline and Month 6|Incidence of major adverse cardiac events between baseline and 6 months. (Incidence rate)||events|||Number
784266|NCT00823836|Secondary|Mean Change From Week 0 in Awake Time Spent “Off” at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group|"Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Mean change from Week 0 in Off time (actual hours) was calculated as Off time (hours) at Week 54 minus Off time (hours) at Week 0."|Weeks 0 and 54|Long-FAS. Participants who had 0 hour as Off time at Week 0 were excluded from the analysis. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis.||hours||Standard Deviation|Mean
784267|NCT00823836|Secondary|"Percentage of Responders in Percent Change From Week 0 in Awake Time Spent Off at Week 54 in the Long-term Phase"|"Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Responders were defined as participants with a 20 percent or greater reduction on percent change from Week 0 in Off time (percentage)."|Week 54|Long-FAS. Participants who had 0 hour as Off time at Week 0 were excluded from the analysis. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis.||percentage of participants|||Number
784268|NCT00823836|Secondary|"Percentage of Responders in Change From Week 0 in Awake Time Spent Off at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group"|"Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Responders were defined as participants with a 20 percent or greater reduction in change from Week 0 in Off time (percentage)."|Week 54|Long-FAS. Participants who had 0 hour as Off time at Week 0 were excluded from the analysis. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis.||percentage of participants|||Number
784269|NCT00823836|Secondary|Percentage of Responders on the CGI-I at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group|The CGI-I assesses the participant's improvement or worsening of PD from baseline with the following eight grades: 0 = Not Assessed, 1 = Very Much Improved, 2 = Much Improved, 3 = Minimally Improved, 4 = No Change, 5 = Minimally Worse, 6 = Much Worse, and 7 = Very Much Worse. Responders are defined as those participants with scores of very much improved or much improved.|Week 54|Long-FAS. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis.||percentage of participants|||Number
784270|NCT00823836|Secondary|Japanese UPDRS Part IV Total Score at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group|The Japanese UPDRS assesses the status of PD patients objectively. Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications.|Weeks 0 and 54|Long-FAS. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis for Week 54.||scores on a scale||Standard Deviation|Mean
784271|NCT00823836|Secondary|Japanese UPDRS Part III Total Score at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group|The Japanese UPDRS assesses the status of PD patients objectively. Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms.|Weeks 0 and 54|Long-FAS. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis for Week 54.||scores on a scale||Standard Deviation|Mean
784272|NCT00823836|Secondary|"Japanese UPDRS Part II (at Off) Total Score at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group"|"The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. Off state is defined as the state at which PD symptoms are not adequately controlled by the drug."|Weeks 0 and 54|"Long-FAS. Only participants who had off state were included in the analysis. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis for Week 54."||scores on a scale||Standard Deviation|Mean
784273|NCT00823836|Secondary|"Japanese UPDRS Part II (at On) Total Score at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group"|"The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. On state is defined as the state at which PD symptoms are well controlled by the drug."|Weeks 0 and 54|Long-FAS. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis for Week 54.||scores on a scale||Standard Deviation|Mean
784274|NCT00823836|Secondary|Japanese UPDRS Part I Total Score at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group|The Japanese UPDRS assesses the status of PD patients objectively. Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms.|Weeks 0 and 54|Long-FAS. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis for Week 54.||scores on a scale||Standard Deviation|Mean
784292|NCT00823836|Secondary|Japanese UPDRS Part I Total Score at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase|The Japanese UPDRS assesses the status of PD patients objectively. Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms.|Week 24 and FAP (from Week 26 up to Week 32)|Switching-FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included in the analysis for the FAP.||scores on a scale||Standard Deviation|Mean
784275|NCT00823836|Secondary|Mean Change From Week 0 in the Japanese UPDRS Part IV Total Score at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group|The Japanese UPDRS assesses the status of PD patients objectively. Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications. Mean change from Week 0 was calculated as the total score at Week 54 minus the total score at Week 0.|Weeks 0 and 54|Long-FAS. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis.||scores on a scale||Standard Deviation|Mean
784276|NCT00823836|Secondary|Mean Change From Week 0 in the Japanese UPDRS Part III Total Score at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group|The Japanese UPDRS assesses the status of PD patients objectively. Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. Mean change from Week 0 was calculated as the total score at Week 54 minus the total score at Week 0.|Weeks 0 and 54|Long-FAS. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis.||scores on a scale||Standard Deviation|Mean
784277|NCT00823836|Secondary|"Mean Change From Week 0 in the Japanese UPDRS Part II (at Off) Total Score at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group"|"The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Mean change from Week 0 was calculated as the total score at Week 54 minus the total score at Week 0."|Weeks 0 and 54|"Long-FAS. Only participants who had off state were included in the analysis. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis."||scores on a scale||Standard Deviation|Mean
784278|NCT00823836|Secondary|"Mean Change From Week 0 in the Japanese UPDRS Part II (at On) Total Score at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group"|"The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. On state is defined as the state at which PD symptoms are well controlled by the drug. Mean change from Week 0 was calculated as the total score at Week 54 minus the total score at Week 0."|Weeks 0 and 54|Long-FAS. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis.||scores on a scale||Standard Deviation|Mean
784279|NCT00823836|Secondary|Mean Change From Week 0 in the Japanese UPDRS Part I Total Score at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group|The Japanese UPDRS assesses the status of PD patients objectively. Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms. Mean change from Week 0 was calculated as the total score at Week 54 minus the total score at Week 0.|Weeks 0 and 54|Long-FAS. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis.||scores on a scale||Standard Deviation|Mean
784280|NCT00823836|Secondary|Percentage of Responders on the Japanese UPDRS Part III Total Score at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group|Thirty percent responders were defined as participants with a 30 percent or greater reduction from Week 0 (Baseline) in the Japanese UPDRS Part III total score. Twenty percent responders were defined as participants with a 20 percent or greater reduction from Week 0 in the Japanese UPDRS Part III total score.|Week 54|Long-FAS: participants who were included in the FAS and entered into the Long-term Phase. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis.||percentage of participants|||Number
784281|NCT00823836|Secondary|Percentage of Participants Remaining in the Study on the Indicated Days During the PR/XR Switching Phase in the Ropinirole IR-Ropinirole PR Group|The percentage of participants remaining in the study was presented by Kaplan-Meier method, where premature discontinuation (i.e., withdrawal before Week 32) was the event, and participants who had completed the phase were censored.|0-89 days within the PR/XR Switching Phase (between Weeks 24 and 32)|Switching-FAS. Data were evaluated only at the time point at which they had been collected.||percentage of participants|||Number
784282|NCT00823836|Secondary|Percentage of Participants Remaining in the Study on the Indicated Days During the PR/XR Switching Phase in the Ropinirole PR-Ropinirole PR Group|The percentage of participants remaining in the study was presented by Kaplan-Meier method, where premature discontinuation (i.e., withdrawal before Week 32) was the event, and participants who had completed the phase were censored.|0-89 days within the PR/XR Switching Phase (between Weeks 24 and 32)|Switching-FAS. Data were evaluated only at the time point at which they had been collected.||percentage of participants|||Number
784283|NCT00823836|Secondary|"Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at Off) at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase"|"The Modified Hoehn & Yahr criteria are measured on the following 8-point scale for disease severity: 0, No signs of disease; 1, Unilateral disease; 1.5, Unilateral plus axial involvement; 2, Bilateral disease; 2.5, Mild bilateral disease; 3, Mild to moderate bilateral disease; 4, Severe disability; and 5, Wheelchair bound or bedridden unless aided. Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Only participants who had off state were included in the analysis."|Week 24 and FAP (from Week 26 up to Week 32)|Switching-FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included in the analysis for the FAP.||participants|||Number
784284|NCT00823836|Secondary|"Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at On) at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase"|"The Modified Hoehn & Yahr criteria are measured on the following 8-point scale for disease severity: 0, No signs of disease; 1, Unilateral disease; 1.5, Unilateral plus axial involvement; 2, Bilateral disease; 2.5, Mild bilateral disease; 3, Mild to moderate bilateral disease; 4, Severe disability; and 5, Wheelchair bound or bedridden unless aided. On state is defined as the state at which PD symptoms are well controlled by the drug."|Week 24 and FAP (from Week 26 up to Week 32)|Switching-FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included in the analysis for the FAP.||participants|||Number
784285|NCT00823836|Secondary|Mean Change From Week 24 in Awake Time Spent “On” With Troublesome Dyskinesias at FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase|"On state is defined as the state at which PD symptoms are well controlled by the drug. Troublesome dyskinesia is defined as dyskinesia that interferes with the participant's daily activity. Mean change from Week 24 on On time with troublesome dyskinesias (actual hours) was calculated as On time with troublesome dyskinesias (hours) at FAP minus On time with troublesome dyskinesias (hours) at Week 24. Participants who had 0 hour as On time with troublesome dyskinesias at Week 24 were excluded from the analysis."|Week 24 and FAP (from Week 26 up to Week 32)|Switching-FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were also not included in the analysis.||hours||Standard Deviation|Mean
784286|NCT00823836|Secondary|Mean Change From Week 24 in Percentage of Awake Time Spent “Off” at FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase|"Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Off time is measured as a proportion using the following formula: (Sum of two days off time [hours]/Sum of two days awake time [hours]) x 100. Change from Week 24 in Off time is measured using the following formula: Off time (proportion) at FAP minus Off time (proportion) at Week 24. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included in the analysis."|Week 24 and FAP (from Week 26 up to Week 32)|Switching-FAS. Participants who had 0 hour as Off time at Week 24 were excluded from the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values.||percentage of time||Standard Deviation|Mean
784287|NCT00823836|Secondary|Mean Change From Week 24 in Awake Time Spent “Off” at FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase|"Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Mean change from Week 24 in Off time (actual hours) was calculated as Off time (hours) at FAP minus Off time (hours) at Week 24. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included in the analysis."|Week 24 and FAP (from Week 26 up to Week 32)|Switching-FAS. Participants who had 0 hour as Off time at Week 24 were excluded from the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values.||hours||Standard Deviation|Mean
784288|NCT00823836|Secondary|Japanese UPDRS Part IV Total Score at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase|The Japanese UPDRS assesses the status of PD patients objectively. Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications. One participant whose observation could not be obtained at Week 24 was not included in the analysis for Week 24.|Week 24 and FAP (from Week 26 up to Week 32)|Switching-FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included in the analysis for the FAP.||scores on a scale||Standard Deviation|Mean
784289|NCT00823836|Secondary|Japanese UPDRS Part III Total Score at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase|The Japanese UPDRS assesses the status of PD patients objectively. Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. One participant whose observation could not be obtained at Week 24 was not included in the analysis for Week 24.|Week 24 and FAP (from Week 26 up to Week 32)|Switching-FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included in the analysis for the FAP.||scores on a scale||Standard Deviation|Mean
784290|NCT00823836|Secondary|"Japanese UPDRS Part II (at Off) Total Score at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase"|"The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Only participants who had off state were included in the analysis."|Week 24 and FAP (from Week 26 up to Week 32)|Switching-FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included in the analysis for the FAP.||scores on a scale||Standard Deviation|Mean
784291|NCT00823836|Secondary|"Japanese UPDRS Part II (at On) Total Score at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase"|"The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. On state is defined as the state at which PD symptoms are well controlled by the drug."|Week 24 and FAP (from Week 26 up to Week 32)|Switching-FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included in the analysis for the FAP.||scores on a scale||Standard Deviation|Mean
784293|NCT00823836|Secondary|Mean Change From Week 24 in the Japanese UPDRS Part IV Total Score at FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase|The Japanese UPDRS assesses the status of PD patients objectively. Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications. Mean change from Week 24 was calculated as the total score at FAP minus the total score at Week 24.|Week 24 and FAP (from Week 26 up to Week 32)|Switching-FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included in the analysis.||scores on a scale||Standard Deviation|Mean
784294|NCT00823836|Secondary|Mean Change From Week 24 in the Japanese UPDRS Part III Total Score at FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase|The Japanese UPDRS assesses the status of PD patients objectively. Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. Mean change from Week 24 was calculated as the total score at FAP minus the total score at Week 24.|Week 24 and FAP (from Week 26 up to Week 32)|Switching-FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included in the analysis.||scores on a scale||Standard Deviation|Mean
784295|NCT00823836|Secondary|"Mean Change From Week 24 in the Japanese UPDRS Part II (at Off) Total Score at FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase"|"The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. Off state is where PD symptoms are not adequately controlled by the drug. Mean change from Week 0 was calculated as the total score at FAP minus the total score at Week 0. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included in the analysis."|Week 24 and FAP (from Week 26 up to Week 32)|"Switching-FAS. Only participants who had off state were included in the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values."||scores on a scale||Standard Deviation|Mean
784296|NCT00823836|Secondary|"Mean Change From Week 24 in the Japanese UPDRS Part II (at On) Total Score at FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase"|"The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. On state is defined as the state at which PD symptoms are well controlled by the drug. Mean change from Week 24 was calculated as the total score at FAP minus the total score at Week 24."|Week 24 and FAP (from Week 26 up to Week 32)|Switching-FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included in the analysis.||scores on a scale||Standard Deviation|Mean
784297|NCT00823836|Secondary|Mean Change From Week 24 (Period Baseline) in the Japanese UPDRS Part I Total Score at FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase|The Japanese UPDRS assesses the status of PD patients objectively. Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms. Mean change from Week 24 was calculated as the total score at FAP minus the total score at Week 24. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included.|Week 24 and FAP (from Week 26 up to Week 32)|Switching-FAS: participants who were included in the FAS and progressed to the PR/XR Switching Phase. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values.||scores on a scale||Standard Deviation|Mean
784298|NCT00823836|Secondary|Percentage of Participants Remaining in the Study on the Indicated Days During the Non-Inferiority Verification Phase in the Ropinirole IR-Ropinirole PR Group|The percentage of participants remaining in the study was presented by Kaplan-Meier method, where premature discontinuation (i.e., withdrawal before Week 24) was the event, and participants who had completed the phase were censored.|0-175 days (up to Week 24)|FAS. Data were evaluated only at the time point at which they had been collected.||percentage of participants|||Number
784299|NCT00823836|Secondary|Percentage of Participants Remaining in the Study on the Indicated Days During the Non-Inferiority Verification Phase in the Ropinirole PR-Ropinirole PR Group|The percentage of participants remaining in the study was presented by Kaplan-Meier method, where premature discontinuation (i.e., withdrawal before Week 24) was the event, and participants who had completed the phase were censored.|0-175 days (up to Week 24)|FAS. Data were evaluated only at the time point at which they had been collected.||percentage of participants|||Number
784300|NCT00823836|Secondary|"Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at Off) at Week 0 and FAP (up to Week 24) in the Non-Inferiority Verification Phase"|"The Modified Hoehn & Yahr criteria are measured on the following 8-point scale for disease severity: 0, No signs of disease; 1, Unilateral disease; 1.5, Unilateral plus axial involvement; 2, Bilateral disease; 2.5, Mild bilateral disease; 3, Mild to moderate bilateral disease; 4, Severe disability; and 5, Wheelchair bound or bedridden unless aided. Off state is defined as the state at which PD symptoms are not adequately controlled by the drug."|Week 0 and FAP (up to Week 24)|"FAS. Only participants who had off state were included in the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis for the FAP."||participants|||Number
784326|NCT00823979|Secondary|Lersivirine Success Percentage With Reference to Median Minimum Observed Plasma Concentration (Cmin)|Simple quartile exposure analysis of success rate (viral load <50 copies/mL) versus median Cmin assesses the exposure response relationship. Percentage of participants with HIV-1 RNA level <50 copies/mL at median Cmin quartile were planned to be reported.|Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48|Due to the sparsity of the data, the ability to interpret the pharmacokinetic/pharmacodynamic (PK/PD) results was limited, thus the data was not reported.|||||
784301|NCT00823836|Secondary|"Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at On) at Week 0 and FAP (up to Week 24) in the Non-Inferiority Verification Phase"|"The Modified Hoehn & Yahr criteria are measured on the following 8-point scale for disease severity: 0, No signs of disease; 1, Unilateral disease; 1.5, Unilateral plus axial involvement; 2, Bilateral disease; 2.5, Mild bilateral disease; 3, Mild to moderate bilateral disease; 4, Severe disability; and 5, Wheelchair bound or bedridden unless aided. On state is defined as the state at which PD symptoms are well controlled by the drug."|Week 0 and FAP (up to Week 24)|FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis for the FAP.||participants|||Number
784302|NCT00823836|Secondary|"Mean Change From Week 0 in Percentage of Awake Time Spent On With Troublesome Dyskinesias at FAP (up to Week 24) in the Non-Inferiority Verification Phase"|"On time with troublesome dyskinesias is measured as a proportion using the following formula: (Sum of two days On time with troublesome dyskinesias [hours]/Sum of two days awake time [hours]) x 100. Change from Week 0 in On time with troublesome dyskinesias is measured using the following formula: On time with troublesome dyskinesias (proportion) at FAP minus On time with troublesome dyskinesias (proportion) at Week 0. Participants who had only one observation for On time with troublesome dyskinesias were not included in the analysis."|Week 0 and FAP (up to Week 24)|FAS. Participants who had 0 hour as On time with troublesome dyskinesias at Week 0 were excluded from the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis.||percentage of time||Standard Deviation|Mean
784303|NCT00823836|Secondary|"Mean Change From Week 0 in Awake Time Spent On With Troublesome Dyskinesias at FAP (up to Week 24) in the Non-Inferiority Verification Phase"|"On state is defined as the state at which PD symptoms are well controlled by the drug. Troublesome dyskinesia is defined as dyskinesia that interferes with the participant's daily activity. Mean change from Week 0 in On time with troublesome dyskinesias (actual hours) was calculated as On time with troublesome dyskinesias (hours) at FAP minus On time with troublesome dyskinesias (hours) at Week 0. Participants who had only one observation for On time with troublesome dyskinesias were not included in the analysis."|Week 0 and FAP (up to Week 24)|FAS. Participants who had 0 hour as On time with troublesome dyskinesias at Week 0 were excluded from the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis.||hours||Standard Deviation|Mean
784304|NCT00823836|Secondary|Mean Change From Week 0 in Percentage of Awake Time Spent “On” at FAP (up to Week 24) in the Non-Inferiority Verification Phase|"On state is defined as the state at which PD symptoms are well controlled by the drug. On time is measured as a proportion using the following formula: (Sum of two days On time [hours]/Sum of two days awake time [hours]) x 100. Change from Week 0 in On time is measured using the following formula: On time (proportion) at FAP minus On time (proportion) at Week 0. Participants who had only one observation for On time were not included in the analysis."|Week 0 and FAP (up to Week 24)|FAS. Participants who had 0 hour as On time at Week 0 were excluded from the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis.||percentage of time||Standard Deviation|Mean
784305|NCT00823836|Secondary|"Mean Change From Week 0 in Awake Time Spent On at FAP (up to Week 24) in the Non-Inferiority Verification Phase"|"On state is defined as the state at which PD symptoms are well controlled by the drug. Mean Change from Week 0 in On time (actual hours) was calculated as On time (hours) at FAP minus On time (hours) at Week 0. Participants who had only one observation for On time were not included in the analysis."|Week 0 and FAP (up to Week 24)|FAS. Participants who had 0 hour as On time at Week 0 were excluded from the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis.||hours||Standard Deviation|Mean
784306|NCT00823836|Secondary|"Mean Percent Change From Week 0 in Percentage of Awake Time Spent Off at FAP (up to Week 24) in the Non-Inferiority Verification Phase"|"Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Off time is measured as a proportion using the following formula: (Sum of two days off time [hours]/Sum of two days awake time [hours]) x 100. Percent change from Week 0 in Off time (proportion) is measured using the following formula: (Change from Week 0 in Off time [proportion]/Off time [proportion] at Week 0) x 100."|Week 0 and FAP (up to Week 24)|FAS. Participants who had 0 hour as Off time at Week 0 were excluded from the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis.||percent change||Standard Deviation|Mean
784307|NCT00823836|Secondary|"Mean Change From Week 0 in Percentage of Awake Time Spent Off at FAP (up to Week 24) in the Non-Inferiority Verification Phase"|"Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Off time is measured as a proportion using the following formula: (Sum of two days off time [hours]/Sum of two days awake time [hours]) x 100. Change from Week 0 in Off time is measured using the following formula: Off time (proportion) at FAP minus Off time (proportion) at Week 0."|Week 0 and FAP (up to Week 24)|FAS. Participants who had 0 hour as Off time at Week 0 were excluded from the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis.||percentage of time||Standard Deviation|Mean
784308|NCT00823836|Secondary|"Mean Change From Week 0 in Awake Time Spent Off at FAP (up to Week 24) in the Non-Inferiority Verification Phase"|"Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Mean change from Week 0 in Off time (actual hours) was calculated as Off time (hours) at FAP minus Off time (hours) at Week 0."|Week 0 and FAP (up to Week 24)|FAS. Participants who had 0 hour as Off time at Week 0 were excluded from the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis.||hours||Standard Deviation|Mean
784309|NCT00823836|Secondary|"Percentage of Responders in Percent Change From Week 0 in Awake Time Spent Off at FAP (up to Week 24) in the Non-Inferiority Verification Phase"|"Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Responders were defined as participants with a 20 percent or greater reduction in percent change from Week 0 in Off time (percentage)."|FAP (up to Week 24)|FAS. Participants who had 0 hour as Off time at Week 0 were excluded from the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis.||percentage of participants|||Number
784310|NCT00823836|Secondary|"Percentage of Responders in Change From Week 0 in Awake Time Spent Off at FAP (up to Week 24) in the Non-Inferiority Verification Phase"|"Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Responders were defined as participants with a 20 percent or greater reduction on change from Week 0 in Off time (percentage)."|FAP (up to Week 24)|FAS. Participants who had 0 hour as Off time at Week 0 were excluded from the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis.||percentage of participants|||Number
784311|NCT00823836|Secondary|Percentage of Responders on the Clinical Global Impression-Improvement (CGI-I) at FAP (up to Week 24) in the Non-Inferiority Verification Phase|The CGI-I assesses the participant's improvement or worsening of PD from Baseline with the following eight grades: 0 = Not Assessed, 1 = Very Much Improved, 2 = Much Improved, 3 = Minimally Improved, 4 = No Change, 5 = Minimally Worse, 6 = Much Worse, and 7 = Very Much Worse. Responders are defined as those participants with scores of very much improved or much improved.|FAP (up to Week 24)|FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis.||percentage of participants|||Number
784312|NCT00823836|Secondary|Japanese UPDRS Part IV Total Score at Week 0 and FAP (up to Week 24) in the Non-inferiority Verification Phase|The Japanese UPDRS assesses the status of PD patients objectively. Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications.|Week 0 and FAP (up to Week 24)|FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis for the FAP.||scores on a scale||Standard Deviation|Mean
784313|NCT00823836|Secondary|Japanese UPDRS Part III Total Score at Week 0 and FAP (up to Week 24) in the Non-inferiority Verification Phase|The Japanese UPDRS assesses the status of PD patients objectively. Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms.|Week 0 and FAP (up to Week 24)|FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis for the FAP.||scores on a scale||Standard Deviation|Mean
784314|NCT00823836|Secondary|"Japanese UPDRS Part II (at Off) Total Score at Week 0 and FAP (up to Week 24) in the Non-inferiority Verification Phase"|"The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. Off state is defined as the state at which PD symptoms are not adequately controlled by the drug."|Week 0 and FAP (up to Week 24)|"FAS. Only participants who had off state were included in the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis for the FAP."||scores on a scale||Standard Deviation|Mean
784315|NCT00823836|Secondary|"Japanese UPDRS Part II (at On) Total Score at Week 0 and FAP (up to Week 24) in the Non-inferiority Verification Phase"|"The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. On state is defined as the state at which PD symptoms are well controlled by the drug."|Week 0 and FAP (up to Week 24)|FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis for the FAP.||scores on a scale||Standard Deviation|Mean
784316|NCT00823836|Secondary|Japanese UPDRS Part I Total Score at Week 0 and FAP (up to Week 24) in the Non-inferiority Verification Phase|The Japanese UPDRS assesses the status of PD patients objectively. Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms.|Week 0 and FAP (up to Week 24)|FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis for the FAP.||scores on a scale||Standard Deviation|Mean
784317|NCT00823836|Secondary|Mean Change From Week 0 in the Japanese UPDRS Part IV Total Score at FAP (up to Week 24) in the Non-Inferiority Verification Phase|The Japanese UPDRS assesses the status of PD patients objectively. Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications. Mean change from Week 0 was calculated as the total score at FAP minus the total score at Week 0.|Week 0 and FAP (up to Week 24)|FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 and who had only one observation for the part IV total score were not included in the analysis.||scores on a scale||Standard Deviation|Mean
784327|NCT00823979|Secondary|Population Pharmacokinetics (PK) of Lersivirine|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48||||||
784318|NCT00823836|Secondary|"Mean Change From Week 0 in the Japanese UPDRS Part II (at Off) Total Score at Week 24 in the Non-Inferiority Verification Phase"|"The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Mean change from Week 0 was calculated as the total score at FAP minus the total score at Week 0. Particpants with only one observation for the part II (at Off) total score were not included in the analysis."|Week 0 and FAP (up to Week 24)|"FAS. Only participants who had Off state were included in the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis."||scores on a scale||Standard Deviation|Mean
784319|NCT00823836|Secondary|"Mean Change From Week 0 in the Japanese UPDRS Part II (at On) Total Score at FAP (up to Week 24) in the Non-Inferiority Verification Phase"|"The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. On state is defined as the state at which PD symptoms are well controlled by the drug. Mean change from Week 0 was calculated as the total score at FAP minus the score at Week 0."|Week 0 and FAP (up to Week 24)|"FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 and who had only one observation for the part II (at On) total score were not included in the analysis."||scores on a scale||Standard Deviation|Mean
784320|NCT00823836|Secondary|Mean Change From Week 0 in the Japanese UPDRS Part I Total Score at FAP (up to Week 24) in the Non-Inferiority Verification Phase|The Japanese UPDRS assesses the status of PD patients objectively. Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms. Mean change from Week 0 was calculated as the total score at FAP minus the total score at Week 0.|Week 0 and FAP (up to Week 24)|FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 and who had only one observation for the part I total score were not included in the analysis.||scores on a scale||Standard Deviation|Mean
784321|NCT00823836|Secondary|Percentage of Responders on the Japanese UPDRS Part III Total Score at FAP (up to Week 24) in the Non-Inferiority Verification Phase|Thirty percent responders were defined as participants with a 30 percent or greater reduction from Week 0 in the Japanese UPDRS Part III total score. Twenty percent responders were defined as participants with a 20 percent or greater reduction from Week 0 in the Japanese UPDRS Part III total score. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 and who had only one measurement for the part III total score were not included in the analysis.|FAP (up to Week 24)|FAS: participants who were progressed to the Non-Inferiority Verification Phase but excluding those who did not have the target indication, those who had not received at least one dose of investigational product, and those whose measured data in efficacy were not available after treatment initiation.||percentage of participants|||Number
784322|NCT00823836|Primary|Mean Change From Week 0 (Baseline) in the Japanese Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score at the Final Assessment Point (FAP) (up to Week 24) in the Non-Inferiority Verification Phase|The Japanese UPDRS assesses the status of Parkinson's Disease (PD) patients objectively. Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. Mean change from Week 0 was calculated as the total score at FAP minus the total score at Week 0. Participants who withdrew before Week 2 and who had only one observation for the part III total score were not included in the analysis.|Week 0 and FAP (up to Week 24)|Per Protocol Set (PPS): participants with exclusion from the Full Analysis Set (FAS) of those violating the study protocol and assessed to be excluded from the assessment of drug efficacy. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2.||scores on a scale||Standard Deviation|Mean
784323|NCT00823901|Primary|Mean Change in Number of Inflammatory Lesions From Baseline to Week 12|The number of inflammatory lesions (papules and pustules) on the face were counted by a dermatologist at baseline and week 12 for each participant. Change in the number of inflammatory lesions is defined as week 12 values minus the baseline values of the participant. Last observation carried forward (LOCF) method was used for missing values.|Baseline, week 12|Intent to treat (ITT) population. Participants who were randomized but only had baseline visit (never began treatment) were excluded from the analysis. Last observation carried forward (LOCF) was also used.||lesions||Standard Deviation|Mean
784324|NCT00823966|Primary|Number of Participants Who Improved in Number of HIV- Ribonucleic Acid (RNA) Copies, Cluster of Differentiation 4(CD4) Count, and Not Progress in HIV Classification: Centers for Disease Control and Prevention Clinical Category (CDC Category).|"Improvement of number of HIV-RNA copies; Improvement is measured by general evaluation of decrease in HIV-RNA copies.
Improvement of CD4 counts; Improvement is measured by general evaluation of increase in CD4 counts.
Not progress in HIV classification (severity of CDC category); Subjects were classified based on the severity of CDC category as mild (Category A), moderate (Category B), and severe (Category C). No change categories from Category A to Category B / Category C, or from Category B to Category C in CDC category."|One year|The efficacy analysis population included all subjects from the safety analysis population in whom the efficacy of this drug could be evaluated.||participants|||Number
784325|NCT00823966|Primary|Number of Participants Who Reported Unlisted Adverse Drug Reaction.|Adverse drug reaction that is not listed in the Japanese Package Insert(Same as Local product Document).|One Year|The safety analysis population included enrolled subjects who had received at least 1 confirmed, administration of delavirdine mesylate.||participants|||Number
784328|NCT00823979|Secondary|Number of Participants With Laboratory Test Abnormalities|Laboratory analysis included blood chemistry, hematology and urinalysis.|Baseline up to Week 48 or early termination|Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||participants|||Number
784329|NCT00823979|Secondary|Number of Participants With Non-nucleoside Reverse Transcriptase Inhibitors (NNRTI) Resistance-Associated Mutations (RAMs) and/or Phenotypic Susceptibility at Time of Treatment Failure Through Week 48|Genotypic and phenotypic resistance to NNRTIs based on International Acquired Immunodeficiency Syndrome (AIDS) Society, United States of America (IAS-USA) RAM guidelines were evaluated using Monogram Biosciences PhenoSenseGT Assay at Baseline. This was then repeated for all participants with HIV-1 viral load >500 copies/mL at treatment failure, up to Week 48.|Baseline through Week 48|Virology analysis set included a subset of participants from TLOVR50 failures who had valid genotypic or phenotypic susceptibility testing result and with plasma HIV-1 RNA >500 copies/mL at baseline and treatment failure.||participants|||Number
784330|NCT00823979|Secondary|Change From Baseline in Cluster of Differentiation 4 (CD4+) Percentage Lymphocyte Counts at Week 24, 48, 96|Blood samples for immunological status assessed by CD4+ lymphocyte count. Baseline value was calculated as the average of the measurements collected prior to and including Day 1 pre-dose.|Baseline, Week 24, 48, 96|ITT population included all randomized participants who received at least 1 dose of study drug. Missing values were imputed using LOCF. Participants with missing baseline or no CD4+ count available on treatment imputed as no or zero change from baseline.||percentage of total lymphocytes||Standard Deviation|Mean
784331|NCT00823979|Secondary|Change From Baseline in Cluster of Differentiation 4 (CD4+) Absolute Lymphocyte Counts at Week 24, 48 and 96|Blood samples for immunological status assessed by CD4+ lymphocyte count. Baseline value was calculated as the average of the measurements collected prior to and including Day 1 pre-dose.|Baseline, Week 24, 48, 96|ITT population included all randomized participants who received at least 1 dose of study drug. Missing values were imputed using LOCF. Participants with missing baseline or no CD4+ count available on treatment imputed as no or zero change from baseline.||cells per microliter (cells/mcL)||Standard Deviation|Mean
784332|NCT00823979|Secondary|Percentage of Participants With Response as Determined by the Time to Loss of Virologic Response (TLOVR50) Algorithm at Week 24, 48 and 96|TLOVR50 response (50 denotes lower limit of quantification [LLOQ] of assay=50 copies/mL): compliment to TLOVR50 failure. TLOVR50 failure based on observed HIV-1 RNA levels and failure events (death; permanent discontinuation of drug; lost to follow-up; new ARV drug; met treatment failure [TF] criteria). TF: an increase of at least (>=)3 times the baseline plasma HIV-1 RNA level at Week 2 or thereafter; failure to achieve HIV-1 RNA level <50 copies/mL at Week 24; starting at Week 2, an increase in HIV-1 RNA level to detectable levels (>50 copies/mL); HIV-1 RNA <1 log10 decrease from baseline at Week 4 or thereafter. TF were confirmed by second measurement >=14 days after first. Baseline value was calculated as the average of the measurements collected prior to and including Day 1 pre-dose.|Week 24, 48, 96|ITT.Participants who died,discontinued,lost to follow-up,switched/changed dose of ARV drug not allowed by protocol,had missing plasma HIV-1 RNA data at 24,48 weeks were considered to have plasma HIV-1 RNA>=50 copies/mL;were referred as failure. Due to early termination of study,decision was made not to derive TLOVR50 responder analysis for Week 96.||percentage of participants|||Number
784333|NCT00823979|Secondary|Time-Averaged Difference (TAD) in log10 Transformed HIV-1 RNA Levels at Week 24, 48 and 96|TAD was calculated as (area under the curve of HIV-1 RNA levels [log10 copies/mL] from baseline to the time point of interest divided by time period in weeks) minus baseline HIV-1 RNA level (log10 copies/mL). Baseline value calculated as average of measurements collected at prior to and including Day 1 pre-dose. Due to early termination of the study decision was made not to derive TAD results for Week 96.|Week 24, 48, 96|ITT population. Participant discontinued before a visit of interest: TAD imputed as zero; not discontinued but observation was missing at visit: TAD to the last non-missing timepoint; not discontinued and missing values between baseline and visit: ignore missing values; missing baseline or no HIV-1 RNA level assessment: TAD imputed as zero.||log10 copies/mL||Standard Deviation|Mean
784334|NCT00823979|Secondary|Change From Baseline in log10 Transformed HIV-1 RNA Levels at Week 24, 48 and 96|Plasma HIV-1 RNA level was determined by the Roche Amplicor HIV-1 Monitor standard assay (version 1.5). For the log10 scale, all the HIV-1 RNA levels were log10 transformed prior to the average calculations. Baseline value calculated as average of measurements collected prior to and including Day 1 pre-dose.|Baseline, Week 24, 48, 96|ITT population. Participant discontinued before a visit of interest: value imputed as zero; not discontinued but observation is missing: last observation carried forward (LOCF) imputation used; missing baseline or no HIV-1 RNA level assessment: value imputed as zero.||log10 copies/mL||Standard Deviation|Mean
784335|NCT00823979|Secondary|Percentage of Participants With HIV-1 RNA Levels <400 Copies/mL at Week 24, 48 and 96|Plasma HIV-1 RNA level was determined by the Roche Amplicor HIV-1 Monitor standard assay (version 1.5).|Week 24, 48, 96|ITT population. Participants who died,discontinued,lost to follow-up,switched/changed dose of ARV drug not allowed by protocol,had missing plasma HIV-1 RNA data at 24, 48, 96 weeks were considered to have plasma HIV-1 RNA >=400 copies/mL and referred to as failure. n=participants evaluable at specified time point for each arm group, respectively.||percentage of participants|||Number
784336|NCT00823979|Secondary|Percentage of Participants With HIV-1 RNA Levels <50 Copies/mL at Week 48 and 96|Plasma HIV-1 RNA level was determined by the Roche Amplicor HIV-1 Monitor standard assay (version 1.5).|Weeks 48, 96|ITT population. Participants who died, discontinued,lost to follow-up,switched/changed dose of ARV drug not allowed by protocol,had missing plasma HIV-1 RNA data at 48, 96 weeks were considered to have plasma HIV-1 RNA >=50 copies/mL and were referred to as failure. n=participants evaluable at specified time point for each arm group, respectively.||percentage of participants|||Number
784337|NCT00823979|Primary|Percentage of Participants With Human Immunodeficiency Virus Type 1 Ribonucleic Acid (HIV-1 RNA) Levels Less Than (<) 50 Copies/Milliliter (mL) at Week 24|Plasma HIV-1 RNA level was determined by the Roche Amplicor HIV-1 Monitor standard assay (version 1.5).|Week 24|ITT population. Participants who died, discontinued, lost to follow-up, switched/changed dose of anti-retro viral (ARV) drug not allowed by protocol, had missing plasma HIV-1 RNA data at 24 weeks were considered to have plasma HIV-1 RNA >=50 copies/mL and were referred to as failure.||percentage of participants|||Number
784338|NCT00824005|Secondary|Reduction in Fixed Perfusion Defect(s)Via SPECT|Fixed total defect is the stress total defect minus the reversible component.|Measured at Baseline and Month 6|Only participants with both baseline and six month fixed defect data available are included.||percentage of defect that is fixed||Standard Deviation|Mean
784340|NCT00824005|Secondary|LV Diastolic Dimension|Left ventricular (LV) diastolic dimension as assessed by contrast echocardiography|Measured at Baseline and Month 6|Only participants with both baseline and six month LV diastolic data available are included.||mL||Standard Deviation|Mean
784341|NCT00824005|Secondary|Serum BNP Levels in Patients With CHF|Serum b-type natriuretic peptide (BNP) levels in patients with congestive heart failure (CHF). A minority number of patients had pro-BNP collected versus regular BNP; these numbers are reported in the analysis population description.|Measured at Baseline and Month 6|Only participants with both baseline and six month BNP data available are included.||IUs||Standard Deviation|Mean
784342|NCT00824005|Secondary|Exercise Time and Level|Exercise time and level as assessed via six minute walk test. (change in number of feet walked)|Measured at Baseline and Month 6|Only participants with both baseline and six month 6 minute walk data available are included.||feet||Standard Deviation|Mean
784343|NCT00824005|Secondary|Number of Participants With a Decrease in Anti-anginal Medication|Number of participants with a decrease in anti-anginal medication (nitrates needed weekly)|Measured at Baseline and Month 6|Only participants with both baseline and six month anti-anginal medication data available are included.||participants|||Number
784344|NCT00824005|Secondary|Clinical Improvement in NYHA Classification|"Clinical improvement in New York Heart Association (NYHA) classification. The NYHA scale ranges from 1 (best)Mild- no limitation of physical activity due to heart failure to 4 (worst) Severe-Unable to carry out any physical activity without discomfort due to heart failure. Patients receive a rating of 1-4 for their heart failure symptoms. Results reflect the mean change in the total score over time."|Measured at Baseline and Month 6|Only participants with both baseline and six month NYHA class data available are included.||units on a scale||Standard Deviation|Mean
784345|NCT00824005|Secondary|Clinical Improvement in CCS Classification (Angina Pectoris)|"Clinical improvement in Canadian Cardiovascular Society (CCS) functional classification of angina pectoris. The CCS scale ranges from Class I (best)able to conduct ordinary daily activity without causing angina to Class IV (worst) Inability to perform any physical activity without discomfort; anginal symptoms may be present at rest. Patients receive a rating of 1-4 for their anginal symptoms. Results reflect the mean change in the total score over time."|Measured at Baseline and Month 6|Only participants with both baseline and six month CCS data available are included.||units on a scale||Standard Deviation|Mean
784346|NCT00824005|Secondary|Regional Wall Motion by Echocardiography|Movement of the left ventricular wall measured in mm from baseline to six months.|Measured at Baseline and Month 6|Only participants with both baseline and six month wall motion data available are included.||mm||Standard Deviation|Mean
784347|NCT00824005|Secondary|Regional Blood Flow Improvement by MRI (in Eligible Patients)|Regional blood flow improvement as measured by cardiac MRI (in patients who are not contraindicated)|Measured at Baseline and Month 6|The small number of patients without contraindications for MRI (n=17) precluded performing informative analysis on the MRI data.|||||
784348|NCT00824005|Secondary|Regional Wall Motion by MRI (in Eligible Patients)|Regional wall motion as measured by cardiac MRI (in patients who are not contraindicated)|Measured at Baseline and Month 6|The small number of patients without contraindications for MRI (n=17) precluded performing informative analysis on the MRI data.|||||
784349|NCT00824005|Primary|Change in Reversible Defect Size|Adenosine myocardial perfusion (SPECT) tests were collected at baseline and 6 months to identify change in ischemic (reversible) defects. SPECT imaging was performed at rest and after adenosine infusion over 4 minutes. To enhance the detection of viability on resting images, sublingual nitroglycerin was administered 15 minutes before injecting technetium Tc 99m sestamibi for the resting image.|Measured at Baseline and Month 6|Only participants with both baseline and six month reversible defect data available are included.||percentage of reversible defect||Standard Deviation|Mean
784350|NCT00824005|Primary|Change in Left Ventricular End Systolic Volume (LVESV)as Assessed Via Echo|Echocardiographic measurements were performed by an echocardiographic core laboratory. LVESVs were calculated by the modified biplane Simpson method, using myocardial contrast to enhance endocardial definition. To account for patient body surface area, LVESV indices are reported.|Measured at Baseline and Month 6|Only participants with both baseline and six month LVESV data available are included.||mL/m2||Standard Deviation|Mean
784351|NCT00824005|Primary|Change in Maximal Oxygen Consumption (VO2max)|The VO2(max) is assessed using the Naughton treadmill protocol.|Measured at Baseline and Month 6|Only participants with both baseline and 6 month VO2max data available are included.||mL/kg/min||Standard Deviation|Mean
784352|NCT00824044|Primary|QEEG Metrics (ATR, EEG Bispectrum, Cordance Estimates)||12 weeks||||||
784353|NCT00824044|Primary|Hamilton Depression Rating Scale (HAM-D-17) Scores|The Hamilton Depression Rating Scale is a clinician-rated scale used to rate depression severity. The maximum score is a 50 and the minimum score is a 0, where higher scores indicate greater severity. Scores from 14 to 18 indicate moderately severe depression.|12 weeks|The number of participants for analysis was based on the number of participants who completed treatment (12 weeks of CBT or medication)||units on a scale||Standard Deviation|Mean
784354|NCT00824070|Primary|The Aqueous Humor Drug Concentration.|An aqueous humor specimen was collected from the study eye for determination of drug concentration 60 min after study drug instillation.|Visit 2, 1-14 days following screening visit|Statistical Analysis of AH Drug Concentration. Modified intent to treat population (mITT). Subjects with non-missing data.||µg/mL|Participants|Standard Deviation|Mean
784355|NCT00824161|Secondary|Overall Survival|Overall survival is defined as the period from the date of first dose of TAS-109 to death date.|From the initial treatment until 12 months after enrollment of the last patient.|Analysis was Intent to Treat(ITT) population.||months||95% Confidence Interval|Median
784356|NCT00824161|Secondary|Antitumor Activity|Per RECIST Criteria and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall response rate was defined as percentage of patients of CR plus PR in ITT population.|From the date of initial treatment until the date of the first objective documentation of PD or death from any cause.|Intent to treatment(ITT)||percentage of CR plus PR patients||95% Confidence Interval|Number
784357|NCT00824161|Primary|Percentage of Progression Free Survival|The primary endpoint was percentage of progression free survival as defined by the percentage of patients without progressive disease(PD)or death, whichever came first, at 3 months of therapy.|From date of randomization until date of the first documented progressive disease (PD) or death from any cause, whichever came first, assessed up to 3 months.|Analysis was Intent to treatment(ITT) population.||percentage of PFS patients||95% Confidence Interval|Number
784358|NCT00824265|Secondary|Time of Occurrence of Cmax (Tmax) of Ofatumumab|Blood samples were collected from participants who received ofatumumab plus fludarabine and cyclophosphamide predose and 0.5 h after the end of the ofatumumab infusion at treatment Cycle 1 and Cycle 4.|Cycle 1 Week 1, Cycle 1 Week 2, Cycle 4|PK Population: Participants for whom a pharmacokinetic sample was obtained were analyzed, only participants available at the specified time points were analyzed(represented by n=X in the category titles)||Hour||95% Confidence Interval|Geometric Mean
784359|NCT00824265|Secondary|Maximum Concentration (Cmax) and Observed Drug Concentration Prior to the Next Dose (Ctrough) of Ofatumumab|Blood samples were collected to assess the plasma concentration of ofatumumab.Cmax and Ctrough were determined. Blood samples were collected from participants who received ofatumumab plus fludarabine and cyclophosphamide predose and 0.5 h after the end of the ofatumumab infusion at treatment Cycle 1 and Cycle 4 (Days 1, 8, and 85). In addition, predose samples were collected prior to ofatumumab administration at Cycles 2, 3, 5, and 6 (Days 29, 57, 113, and 141).|Cycle 1 Week 1, Cycle 1 Week 2, Cycles 2,3,4,5|PK Population: Participants for whom a pharmacokinetic sample was obtained were analyzed, only participants available at the specified time points were analyzed(represented by n=X in the category titles)||Micrograms per milliliter||95% Confidence Interval|Geometric Mean
784360|NCT00824265|Secondary|Mean Area Under the Time-concentration Curve (AUC) Curve Over the Dosing Interval (AUC[0-tau]) of Ofatumumab|Area under the time-concentration curve (AUC) over the dosing interval (AUC[0-tau]) was evaluated. Blood samples were collected from participants who received ofatumumab plus fludarabine and cyclophosphamide predose and 0.5 h after the end of the ofatumumab infusion at treatment Cycle 1 and Cycle 4 (Days 1, 8, and 85). In addition, predose samples were collected prior to ofatumumab administration at Cycles 2, 3, 5, and 6 (Days 29, 57, 113, and 141).|Cycle 1 Week 1, Cycle 1 Week 2, Cycles 2,3,4,5,6|PK Population: Participants for whom a pharmacokinetic sample was obtained were analyzed, only participants available at the specified time points were analyzed(represented by n=X in the category titles)||hour*nanogram/mililiter (h*ng/mL)||95% Confidence Interval|Geometric Mean
784361|NCT00824265|Secondary|Mean of Health Change Questionnaire (HCQ)|The HCQ consists of a single question in which the participant is asked if he/she has experienced any change in his/her health overall since beginning the study. For HCQ, values from 1 to 9 were assigned to the 9 responses in the HCQ questionnaire, ranging from 1 for ‘my health is a great deal better’ to 9 for ‘my health is a great deal worse’ since the beginning of the study. Lower scores represent better conditions.|Screening, Cycle 3 Day 1, and 1 M and every 3 month post last dose up to 24 month.|ITT Population. Only those participants available at the specified time points were analyzed.||Unit on a scale||Standard Deviation|Mean
784362|NCT00824265|Secondary|Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score|EORTC QLQ-C30, a self-reported, cancer-specific instrument assessing 15 domains: physical, role, emotional, cognitive and social functioning, pain,fatigue, nausea and vomiting, insomnia, loss of appetite, constipation, diarrhea, and dyspnea, financial difficulties and a global health status/quality of life (QOF). Functional and symptoms scales were measured on four point Likert scale where 1 = not at all and 4 = very much. Pat. assessed at Screening; Cycle 4 Day 1 and during follow-up 1 M and every 3 M up to 24 months. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Clinically meaningful changes or minimally important differences (MIDs)have been previously established for the EORTC QLQ C30, and categorized as ‘small’ if the mean change in scores is 5-10 points, ‘moderate’ if 10-20 points, and ‘large’ if >20points.|Screening, Cycle 3 Day 1, and 1 M and every 3 month post last dose up to 24 month.|ITT Population. Only those participants available at the specified time points were analyzed||Scores on a scale||Standard Deviation|Mean
784363|NCT00824265|Secondary|Change From Baseline in Patient Reported Outcome (PRO) as Assessed by EuroQoL Five-Dimension (EQ-5D) Score at Indicated Visit|EQ-5D is comprised of a 5-item health status measure and a visual analogue scale (VAS) and is used to generate two scores: the utility score and the thermometer score. The utility score measures mobility, self-care, usual activities, pain, discomfort, and anxiety/depression. Responses to each of the 5 health states are measured on a 3-point scale (level 1 = no problem; level 2 = some or moderate problem(s) and level 3 = unable, or extreme problems). Responses are typically converted into health utilities or valuations on a scale ranging from 0 (death) to 1 (perfect health). The thermometer score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. A Negative health status describes health state worse than death.Baseline is the most recent, non-missing value prior to or on the first study drug dose date.|Screening, Cycle 3 Day 1, and 1 M and every 3 month post last dose up to 24 month.|ITT Population. Only those participants available at the specified time points were analyzed.||Score on a scale||Standard Deviation|Mean
784364|NCT00824265|Secondary|Changes in Patient Reported Outcome (PRO) Measures and Scores for European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)|The EORTC QLQ-CLL16 is comprised of 16 questions that address 5 domains of health-related quality of life (HRQoL) important in CLL. There are 4 multi-item scales – fatigue (2 items), treatment side effects ([TSE], 4 items), disease symptoms (disease effects scale [DES], 4 items), and infection scale [IS] (4 items) – and single item scales (social activities [Social Problems (SP) Scale] and future health worries[Future Health (FH) Scale].). These are measured on a four point scale where 1 = not at all and 4 = very much. These scores are transformed to give a rating from 0 – 100, where 0 =no symptoms or problems and 100 = a severe symptoms or problems. EORTC QLQ-CLL16 was assessed at Screening; Cycle 4 Day 1 and during follow-up 1 M and every 3 M up to 24 months. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value was obtained at randomization.|Screening, Cycle 3 Day 1, and 1 M and every 3 month post last dose up to 24 month.|Participants||scores on a scale||Standard Deviation|Mean
784394|NCT00824291|Primary|Change From Baseline in Hamilton Depression Scale (HAM-D) at Week 12|HAM-D, clinician-rated interview, measures presence of depressive symptoms in 17 areas (symptoms such as depressed mood, guilt feelings, suicide, sleep disturbances, anxiety levels and weight loss). Total score ranges from 0 to 52; higher scores indicate more depression. Change from baseline: mean at observation minus mean at baseline.|At Baseline and Week 12.|Intent-to-treat (ITT) analysis set, Last Observation Carried Forward (LOCF)||Scores on a scale||Standard Error|Mean
784365|NCT00824265|Secondary|Prognostic and Biological Markers Correlating With Clinical Response|Blood samples were collected for the assessment of the following prognostic markers at BL: immunoglobulin heavy chain variable region(IgVH) homology; Zeta-Chain-Associated Protein Kinase 70(ZAP70), VH3-21 usage; Cytogenetics (by fluorescent in situ hybridization [FISH]); beta 2 microglobulin. Cox-regression model was used to explore the relationship between progression-free survival and the following explanatory variables: treatment group, cytogenetics (analyzed by FISH included 6q-,11q-, +12q, 17p-, 13q-) , ZAP-70 (positive, negative or intermediate), VH3-21 usage (Yes and No), IgVH homology (>98%, 97%-98% and <97%), beta 2 microglobulin (>3500 microgram per liter [µg/L] and <=3500 µg/L). For each covariate, a hazard ratio <1 indicates a lower risk on the first effect tested compared with the other effects tested. Cytogenetics Group (based on >=20%)=cytogenetics (CY G).|From randomization up to 5 years after last dose of study drug|ITT Population. Only those participants available at the specified time points were analyzed.||Participants|||Number
784366|NCT00824265|Secondary|Change From Baseline in Cell Counts, CD5- CD19+|CD5- CD19+ cells were counted by flow cytometry at Screening (baseline) at Cycle 1 Day1, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1 during treatment period and after last dose of study drug at 1 M and then every three month up to 45 M during follow up period. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus. Baseline is defined as the assessment closest to but prior to first dose (e.g. Day 1 if available otherwise screening). Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Screening, Cycle 1 Day1, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1 and after last dose at 1 M and then every three month up to 45 M during Follow-up Period|Safety Population||cells/uL||Standard Deviation|Mean
784367|NCT00824265|Secondary|Change From Baseline in Cluster of Differentiation (CD) Cell Counts, CD5+ and CD19+|CD5+ and CD19+ cells were counted by flow cytometry at Screening (Baseline) on Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1 during the treatment period and after last dose of study drug at 1 M and then every three month follow up up to 45 M. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus. Baseline is defined as the assessment closest to but prior to first dose (e.g. day 1 if available, otherwise, screening). Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Screening, Cycle 1 Day1, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1 and after last dose at 1 M and then every three months up to 45 M during Follow-up Period|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).||cells/uL||Standard Deviation|Mean
784368|NCT00824265|Secondary|Mean Level of Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM|Immunoglobulins, or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Low levels indicate immuno-suppression. Blood samples were collected from each participant and IgA, IgG, and IgM were measured at Baseline, and 1M and 6M after last dose during follow up period.|Baseline, 1M and 6M follow up|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).||Gram per liter||Standard Deviation|Mean
784369|NCT00824265|Secondary|Number of Participants Who Received no Transfusion or at Least One Transfusion During the Study|Participants who received no transfusion and at least one transfusion during the study are presented. Participants who took any blood products or blood supportive care product are included.|From randomization up to 5 years after last dose of study drug|Safety Population||Participants|||Number
784370|NCT00824265|Secondary|Number of Participants With at Least One Grade 3/Grade 4 Myelosuppression (Anemia, Neutropenia, and Thrombocytopenia)|Participants with at least one Grade 3 or Grade 4 myelosuppression (anemia, neutropenia, and thrombocytopenia) are presented. Myelosuppression is defined as the decrease in the ability of the bone marrow to produce blood cells. AEs were graded according to NCI common terminology criteria for adverse events (CTCAE) grade, version 3.0 (1, mild; 2, moderate; 3, severe; 4, life-threatening/disabling; 5, death).|From first dose of study medication to 60 days after the last dose of study medication (for an AE), or up to 5 years after the last dose of study drug or until the time of the next anti-CLL therapy (for SAE)|Safety Population||Participants|||Number
784371|NCT00824265|Secondary|Number of Participants With Drug Related AEs and SAEs of Maximum Severity of Grade 3 or Higher|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Maximum severity grades were evaluated according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version 3.0 (1, mild; 2, moderate; 3, severe; 4, life-threatening/disabling; 5, death).|From first dose of study medication to 60 days after the last dose of study medication (for an AE), or up to 5 years after the last dose of study drug or until the time of the next anti-CLL therapy (for SAE)|Safety Population||Participants|||Number
784372|NCT00824265|Secondary|Number of Participants With Autoimmune Hemolytic Anaemia (AIHA)|"AIHA is a condition where the body's immune system fails to recognize red blood cells as self and begins destroying these red blood cells. The number of participants experienced AIHA are presented."|From first dose of study medication to 60 days after the last dose of study medication (for an AE), or up to 5 years after the last dose of study drug or until the time of the next anti-CLL therapy (for SAE)|Safety Population||Participants|||Number
784373|NCT00824265|Secondary|Number of Participants With a Human Anti-human Antibody (HAHA) Positive Result at Indicated Time Points|Serum samples for analysis of HAHA were collected at Baseline (Screening), after 3 cycles were compelted, after 1 M and 6 M post last dose. All samples were first tested in a screening step; positive samples from the screening were further evaluated in a confirmation test. The confirmed positive samples were reported as HAHA-positive.|From start of study drug until 60 days after the last dose of study medication|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles)||Participants|||Number
784374|NCT00824265|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury.|From first dose of study medication to 60 Days after the last dose of study medication (for an AE), or up to 5 years after the last dose of study drug or until the time of the next anti-CLL therapy (for SAE)|Safety Population: Participants who received at least one dose of a study drug.||Participants|||Number
784375|NCT00824265|Secondary|Number of Participants Who Were Negative for MRD Assessed by Investigator|MRD refers to small number of leukemic cells that remain in the participant during treatment or after treatment at the time the participant achieved a confirmed CR. MRD analysis was performed for the participants who were suspected of achieving a primary endpoint CR. MDR was performed by flow cytometry on a bone marrow or peripheral blood sample taken at least 2 months after final treatment. MRD negative was defined as less than one CLL cell per 10000 leukocytes.|From randomization up to 5 years after last dose of study drug|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).||Participants|||Number
784376|NCT00824265|Secondary|Number of Participants Who Were Negative for Minimal Residual Disease (MRD) Assessed by IRC|MRD refers to small number of leukemic cells that remain in the participant during treatment or after treatment at the time the participant achieved a confirmed CR. MRD analysis was performed for the participants who were suspected of achieving a primary endpoint CR. MDR was performed by flow cytometry on a bone marrow or peripheral blood sample taken at least 2 months after final treatment. MRD negative was defined as less than one CLL cell per 10000 leukocytes.|From randomization up to 5 years after last dose of study drug|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).||Participants|||Number
784377|NCT00824265|Secondary|Percentage of Participants With the Best OR, as Assessed by the Investigator|OR is defined as the number of participants achieving an objective response (complete response [CR], CR with incomplete bone marrow recovery [CRi], partial response [PR], and nodular PR [nPR]). CR (all the criteria at least 2 months after last treatment): no lymphadenopathy (Ly) > 1.5 cm/ hepatomegaly/ splenomegaly/ constitutional symptoms; neutrophils >1500 per microliter (µL), platelets (PL) >100,000/µL, hemoglobin (Hb) >11 grams/deciliter (g/dL), lymphocytes (LC) <4000/µL, bone marrow (BM) sample must be normocellular for age, <30% LC, no lymphoid nodule. CRi: CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to CLL but related to drug toxicity. PR: >=50% decrease in LC, Ly, size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline (BL), Hb >11 g/dL or 50% improvement over BL. nPR: persistent nodules BM.|From randomization up to 5 years after last dose of study drug|ITT Population||Percentage of participants|||Number
784378|NCT00824265|Secondary|Percentage of Participants With the Best Overall Response (OR), as Assessed by the IRC|OR is defined as the number of participants achieving an objective response (complete response [CR], CR with incomplete bone marrow recovery [CRi], partial response [PR], and nodular PR [nPR]). CR (all the criteria at least 2 months after last treatment): no lymphadenopathy (Ly) > 1.5 cm/ hepatomegaly/ splenomegaly/ constitutional symptoms; neutrophils >1500 per microliter (µL), platelets (PL) >100,000/µL, hemoglobin (Hb) >11 grams/deciliter (g/dL), lymphocytes (LC) <4000/µL, bone marrow (BM) sample must be normocellular for age, <30% LC, no lymphoid nodule. CRi: CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to CLL but related to drug toxicity. PR: >=50% decrease in LC, Ly, size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline (BL), Hb >11 g/dL or 50% improvement over BL. nPR: persistent nodules BM.|From randomization up to 5 years after last dose of study drug|ITT Population||Percentage of participants|||Number
784379|NCT00824265|Secondary|Number of Participants With no B-Symptoms or at Least One B-symptoms Over the Time|Participants with no B-symptoms (B-Sy) (no night sweat, no weight loss, no fever and no extreme fatigue) and at least one indicated B-sy(night sweats, weight loss, fever or extreme fatigue) were presented at Screening, Cycle 1 Day 1, Cycle 2 Day1, Cycle 3 Day1, Cycle 4 Day1, Cycle 5 Day1, Cycle 6 Day 1 and during follow up period at 1 M after study drug therapy, then every 3 M up to 5 year (up to 60 months).|Screening, Cycle1 Day 1, Cycle 2 Day1, Cycle 3 Day1, Cycle 4 Day1, Cycle 5 Day1, Cycle 6 Day 1 and During at 1M after study drug therapy, then every 3 M up to 5 year (up to 60 months)|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).||Participants|||Number
784380|NCT00824265|Secondary|Number of Participants With Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status|The ECOG performance status scales and criteria are used by doctors and researchers to assess how a participant's disease is progressing, how the disease affects the daily living, and determines appropriate treatment and prognosis. ECOG performance status are measured at Cycle 2 Day1, Cycle 3 Day1, Cycle 4 Day1, Cycle 5 Day1 and Cycle 6 Day1. During follow period, 1 M after study drug therapy, then every 3 month up to 5 year (up to 60 months). Improvement is defined as a decrease from baseline by at least one step on the ECOG performance status scale (yes/no).|Cycle 2 Day1, Cycle 3 Day1, Cycle 4 Day1, Cycle 5 Day1, Cycle 6 Day1, follow up (FU) at 1Month (M) after study drug therapy, then every 3 month up to 5 year (up to 60 months)|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).||Participants|||Number
784381|NCT00824265|Secondary|Time to Next Therapy|Time to next therapy is defined as the time from randomization until the start of the next-line of treatment.|From the start of study drug until the start of the next anti-CLL therapy (up to 5 years after the last dose of study drug)|ITT Population||Months||95% Confidence Interval|Median
784395|NCT00824369|Secondary|CD4+ Cell Count (Percentage) at Baseline, Month 6 and Month 12|Participant's immunological status assessed by CD4+ lymphocyte count.|Baseline, Month 6 and Month 12|Analysis population consisted of all participants who were enrolled in this study. Only available data were used.||Percentage of total lymphocytes||Standard Deviation|Mean
784396|NCT00824369|Secondary|Absolute Cluster of Differentiation 4+ (CD4+) Cell Count (Cells/uL) at Baseline, Month 6 and Month 12|Participant's immunological status assessed by CD4+ lymphocyte count.|Baseline, Month 6 and Month 12|Analysis population consisted of all participants who were enrolled in this study. Only available data were used.||cells/uL||Standard Deviation|Mean
784382|NCT00824265|Secondary|Time to Progression, as Assessed by the IRC|Time to progression is defined as the time from the date of randomization to PD. PD requires at least one of the following: lymphadenopathy, appearance of any new lesion such as enlargerd lymph nodes (>1.5 cm) spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site; an increase by 50% or more in the previously noted enlargement of the liver or spleen, an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter, transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukaemia.|From randomization up to 5 years after the last dose of study drug|ITT Population.||Months||95% Confidence Interval|Median
784383|NCT00824265|Secondary|Duration of Response (DOR), as Assessed by the IRC|DOR is defined as the time from the initial response (CR, CRi, nPR, or PR) to the first documented sign of PD or death due to any cause. PD requires at least one of the following: lymphadenopathy, appearance of any new lesion such as enlargerd lymph nodes (>1.5 cm) spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site; an increase by 50% or more in the previously noted enlargement of the liver or spleen, an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter, transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukaemia.|From time of initial response to disease progression or death, whichever came first (up to 5 years after the last dose of study drug)|ITT Population. Par with unknown or missing responses were considered as non-responders, only responders were included in this analysis.||Months||95% Confidence Interval|Median
784384|NCT00824265|Secondary|Time to Response, as Assessed by the IRC|Time to response is defined as the time from randomization to the first response. Complete Response/remission(CR) all the criteria at least 2 months after last treatment: no lymphadenopathy(Ly) > 1.5 cm/ hepatomegaly/spleenomegaly/constitutional symptoms; neutrophils >1500 per microliter(µL), platelets(PL) >100,000/µL, hemoglobin(Hb) >11 grams/deciliter(g/dL), lymphocytes(LC) <4000/µL, bone marrow(BM) sample must be normocellular for age, <30% LC, no lymphoid nodule. Incomplete bone marrow recovery(CRi): CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to CLL but related to drug toxicity. Partial Remission/response(PR): >=50% decrease in LC, Ly, size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline(BL), Hb >11 g/dL or 50% improvement over BL. Nodular PR(nPR): persistent nodules BM.|From randomization up to 5 years after last dose of study drug|ITT Population. Participants with unknown or missing responses were considered as non-responders. Only responders were included in the analysis.||Months||95% Confidence Interval|Median
784385|NCT00824265|Secondary|Overall Survival (OS)|Overall survival is defined as the time from randomization to death due to any cause. Each participant was followed at the time when the last IRC-assessed PFS events occurred. Participants who had not died were censored at the date of last contact.|From randomization up to 5 years after last dose of study drug|ITT Population.||Months||95% Confidence Interval|Median
784386|NCT00824265|Primary|Progression-free Survival (PFS), as Assessed by the Independent Review Committee (IRC)|PFS is defined as the interval of time between the date of randomization and the earlier of the date of disease progression (progressive disease,PD) and the date of death due to any cause. PD requires at least one of the following: lymphadenopathy, appearance of any new lesion such as enlargerd lymph nodes (>1.5 cm) spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site; an increase by 50% or more in the previously noted enlargement of the liver or spleen, an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter, transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukaemia.|From randomization up to 5 years after last dose of study drug|Intent-to-Treat (ITT) Population: all participants randomized and received study drug.||Months||95% Confidence Interval|Median
784387|NCT00824291|Secondary|Change From Baseline on Stress and Social Support Scales at Week 12|Stress and Social Support Scales: self-administered rating scale where item 1 is the stress vulnerability scale measuring how much the subject was set back by stressful events on an 11-point scale ranging from 0 (not at all) to 10 (extremely) and item 2 is an 11-point scale ranging from 0 to 100 percent of the amount of support the subject received from relatives and friends.|At Baseline and Week 12.|ITT, LOCF||Scores on a scale||Standard Error|Mean
784388|NCT00824291|Secondary|Change From Baseline on Worry Anxiety Tension Scale (WATS) at Week 12|WATS: a self-administered, 3-question rating scale assesses worry, anxiety, and tension. Each item was a visual analog scale on which the participant circles a number from 0 to 10. Higher scores indicated worse function. WATS total score was the sum of the 3 items. If 1 item was missing, the total score would be missing.|At Baseline and Week 12.|ITT, LOCF||Scores on a scale||Standard Error|Mean
784389|NCT00824291|Secondary|Change From Baseline in Adjusted Mean on Montgomery-Asberg Depression Rating Scale (MADRS) at Week 12|Measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|At Baseline and Week 12.|ITT, LOCF||Scores on a scale||Standard Error|Mean
784390|NCT00824291|Secondary|Change From Baseline on Work and Activities Item of HAM-D17 at Week 12|The Work and Activities Item of the HAM-D17 is item 7 of HAM-D17. Scoring range from 0 to 4.|At Baseline and Week 12.|ITT, LOCF||Scores on a scale||Standard Error|Mean
784391|NCT00824291|Secondary|Clinical Global Impressions Scale - Severity of Illness (CGI-S) at Week 12|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Change: score at observation minus score at baseline.|At Baseline and Week 12.|ITT, LOCF||Scores on a scale|||Number
784392|NCT00824291|Secondary|Clinical Global Impression Scale - Improvement (CGI- I) Score at Week 12|CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. Change = score at observation minus score at baseline.|At Baseline and Week 12.|ITT, LOCF||Scores on a scale|||Number
784393|NCT00824291|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 12|Participant rated scale was used to assess the effect of the participant’s symptoms on their work/social/family life. Total scores range from 0 to 30 with higher values indicating greater disruption in the participant’s work/social/family life. Individual item scores range from 0 to 10.|At Baseline and Week 12.|ITT, LOCF||Scores on a scale||Standard Error|Mean
784397|NCT00824369|Secondary|Number of Participants With HIV 1 RNA Level <50 Copies/mL or Below the Lower Limit of Quantification (LLOQ) of the Assay at Baseline, Month 6, Month 12 and Last Visit|Number of participants with HIV-1 RNA level <50 copies/mL plasma or below the lower limit of quantification (LLOQ) of the Assay were noted at Baseline, Month 6, Month 12 and Last visit. The lower limit of quantification (LLOQ) of the HIV 1 RNA assays ranged from 20 to 70 copies/mL as the assay was performed by local labs.|Baseline, Month 6, Month 12 and Last visit|Analysis population consisted of all participants who were enrolled in this study. Only available data were used.||Number of participants|||Number
784398|NCT00824369|Secondary|Number of Participants With Human Immunodeficiency Virus - 1 (HIV 1) Ribonucleic Acid (RNA) Level <50 Copies/mL at Baseline, Month 6, Month 12 and Last Visit|Number of participants with HIV-1 RNA level <50 copies/mL plasma was noted at baseline, month 6, month 12 and last visit.|Baseline, Month 6, Month 12 and Last visit|Analysis population consisted of all participants who were enrolled. The lower limit of quantification of the HIV 1 RNA assays ranged from 20-70 copies/mL as they were performed by local labs. Participants where the HIV-RNA level was with a LLOQ > 50 copies/mL were not included in the analysis at the visit of interest. Only available data was used.||Number of participants|||Number
784399|NCT00824369|Primary|Number of Participants With Treatment-emergent Adverse Events, Serious Adverse Events and Participants Who Discontinued Due to Adverse Events|The numbers of participants with treatment emergent adverse events, serious adverse events or discontinuation due to adverse events was reported.|End of Study visit or the Early Termination visit|Safety population consisted of all participants who were enrolled in this study.||Number of participants|||Number
784400|NCT00824382|Secondary|AUC0-1,ss|Area under the concentration curve from 0 to 1 hour at steady state using trapezoid rule, only calculated if >1/3 of the patients have available pharmacokinetic parameters, thus not applicable for Olodaterol 2mcg group|visit at week 4|Treated set which is however restricted to patients with evaluable data for this endpoint (Patients in which all plasma concentration values were below limit of quantification (BLQ), were excluded from the analysis and were not included into the total number of participants affected for this outcome measure)||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
784401|NCT00824382|Secondary|AUC0-1|Area under the concentration curve from 0 to 1 hour using trapezoid rule, only calculated if >1/3 of the patients have available pharmacokinetic parameters,thus not applicable for Olodaterol 2mcg group|after first inhalated administration|Treated set which is however restricted to patients with evaluable data for this endpoint (Patients in which all plasma concentration values were below limit of quantification (BLQ), were excluded from the analysis and were not included into the total number of participants affected for this outcome measure)||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
784402|NCT00824382|Secondary|Cmax,ss (Maximum Measured Concentration of the Analyte in Plasma at Steady State)|Cmax,ss only calculated if >1/3 of the patients have available pharmacokinetic parameters, thus not applicable for the Olodaterol 2 mcg|visit at week 4|Treated set which is however restricted to patients with evaluable data for this endpoint (Patients in which all plasma concentration values were below limit of quantification (BLQ), were excluded from the analysis and were not included into the total number of participants affected for this outcome measure)||pg/mL||Geometric Coefficient of Variation|Geometric Mean
784403|NCT00824382|Secondary|Cmax (Maximum Measured Concentration of the Analyte in Plasma)|Cmax only calculated if >1/3 of the patients have available pharmacokinetic parameters,thus not applicable for the Olodaterol 2 mcg|after first inhalated administration|Treated set which is however restricted to patients with evaluable data for this endpoint (Patients in which all plasma concentration values were below limit of quantification (BLQ), were excluded from the analysis and were not included into the total number of participants affected for this outcome measure)||pg/mL||Geometric Coefficient of Variation|Geometric Mean
784404|NCT00824382|Secondary|Difference From Baseline in Potassium|Difference from baseline in Potassium (normalized values). Normalization means that the values from different laboratories are transformed in such a way that they are directly comparable.|Baseline, Week 4|Treated set.||mmol/L||Standard Deviation|Mean
784405|NCT00824382|Secondary|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis, ECG and Physical Examination|Clinical relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis, ECG and Physical examination. New abnormal findings or worsenings of baseline conditions were reported as Adverse Events related to treatment (cardiac disorders and investigations).|4 weeks|Treated set.||percentage of participants|||Number
784406|NCT00824382|Secondary|Weekly Mean Number of Occasions of Rescue Therapy After 4 Weeks|Weekly mean number of occasions of rescue therapy used per day (PRN salbutamol )|Week 4|The full analysis set (FAS) for 4 weeks treatment period which is however restricted to patients with evaluable data for this endpoint - analysis with imputation||Number of puffs||Standard Error|Mean
784407|NCT00824382|Secondary|Weekly Mean Evening PEFR After 4 Weeks|"PEFR measurements were recorded by means of a patient diary on a daily basis. This diary was used to record the twice daily PEFs,
Evening measurements were performed at bedtime.The highest of three readings for each measurement were recorded."|Week 4|The full analysis set (FAS) for 4 weeks treatment period which is however restricted to patients with evaluable data for this endpoint - analysis with imputation||Liter/minute||Standard Error|Least Squares Mean
784408|NCT00824382|Secondary|Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) After 4 Weeks|"PEFR measurements were recorded by means of a patient diary on a daily basis. This diary was used to record the twice daily PEFs,
Morning measurements were performed immediately upon arising before administration of trial and/or rescue medication.The highest of three readings for each measurement were recorded."|Week 4|The full analysis set (FAS) for 4 weeks treatment period which is however restricted to patients with evaluable data for this endpoint - analysis with imputation||Liter/minute||Standard Error|Least Squares Mean
784409|NCT00824382|Secondary|Forced Expiratory Volume in 1 Second (FEV1) (Unsupervised) Area Under Curve 6-12 h (AUC 6-12h) Response After 4 Weeks|"Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Means are adjusted using a model with treatment (trt), baseline as fixed effects and centre as random effect.
FEV1 AUC 6-12h was calculated from 6-12 hours post-dose using the trapezoidal rule, divided by the observation time (6h) to report in liters."|Baseline and after 4weeks treatment|The full analysis set (FAS) for 4 weeks treatment period which is however restricted to patients with evaluable data for this endpoint - analysis with imputation||Liter||Standard Error|Least Squares Mean
784410|NCT00824382|Secondary|Forced Expiratory Volume in 1 Second (FEV1) (Unsupervised) Area Under Curve 0-6h (AUC 0-6h) Response After 4 Weeks|"Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Means are adjusted using a model with treatment (trt), baseline as fixed effects and centre as random effect.
FEV1 AUC 0-6h was calculated from 0-6 hours post-dose using the trapezoidal rule, divided by the observation time (6h) to report in liters."|baseline and after 4weeks treatment|The full analysis set (FAS) for 4 weeks treatment period which is however restricted to patients with evaluable data for this endpoint - analysis with imputation||Liter||Standard Error|Least Squares Mean
784411|NCT00824382|Secondary|FVC Peak(0-3) Response|The change from baseline in FVC peak(0-3) response after 4 weeks of treatment.|baseline and after 4 weeks treatment|The full analysis set (FAS) for 4 weeks treatment period - analysis with imputation||Liter||Standard Error|Least Squares Mean
784412|NCT00824382|Secondary|FVC AUC(0-3) Response|"The change from baseline in FVC AUC(0-3) response after 4 weeks of treatment. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in liters.
Due to normalization the unit is liters."|baseline and after 4 weeks treatment|The full analysis set (FAS) for 4 weeks treatment period - analysis with imputation||Liter||Standard Error|Least Squares Mean
784413|NCT00824382|Secondary|Trough FVC Response at Week 4|The change from baseline in Trough FVC after 4 weeks of treatment|baseline and after 4 weeks treatment|The full analysis set (FAS) for 4 weeks treatment period - analysis with imputation||Liter||Standard Error|Least Squares Mean
784414|NCT00824382|Secondary|FEV1 Peak(0-3) Response at 4 Weeks|The change from baseline in FEV1 peak(0-3) after 4 weeks of treatment.|baseline and after 4 weeks treatment|The full analysis set (FAS) for 4 weeks treatment period - analysis with imputation||Liter||Standard Error|Least Squares Mean
784415|NCT00824382|Secondary|FEV1 AUC(0-3) Response at 4 Weeks|"The change from baseline in FEV1 AUC(0-3) after 4 weeks of treatment. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in liters.
Due to normalization the unit is liters."|baseline and after 4 weeks treatment|The full analysis set (FAS) for 4 weeks treatment period - analysis with imputation||Liter||Standard Error|Least Squares Mean
784416|NCT00824382|Secondary|Trough FEV1 Response at Week 2|Trough FEV1 is defined as the mean of the two FEV1 values (performed at -1 hour and -10 minutes prior to next test-drug inhalation) at the end of the dosing interval, 24 hours post-drug administration. Trough FEV1 response is defined as the change from baseline in trough FEV1. Baseline trough FEV1 is the mean of the two pre-treatment FEV1 values measured at Visit 2 prior to administration of the first dose of study medication|baseline and after 2 weeks treatment|The full analysis set (FAS) - analysis with imputation||Liter||Standard Error|Least Squares Mean
784417|NCT00824382|Primary|Trough FEV1 Response at Week 4|The change from baseline in trough FEV1 after 4 weeks of treatment. Trough FEV1 is defined as the mean of the two FEV1 values (performed at -1 hour and -10 minutes prior to next test-drug inhalation) at the end of the dosing interval, 24 hours post-drug administration. Trough FEV1 response is defined as the change from baseline . Baseline trough FEV1 is the mean of the two pre-treatment FEV1 values measured at Visit 2 prior to administration of the first dose of study medication.|baseline and after 4 weeks treatment|The full analysis set (FAS) for 4 weeks treatment period - analysis with imputation||Liter||Standard Error|Least Squares Mean
784418|NCT00824408|Secondary|Vss of Pemetrexed|Vss - apparent volume of distribution at steady state following IV administration of pemetrexed|5 minutes before pemetrexed infusion, at the end of the infusion and 1.5 hours (h), 2.5h, 4.5h and 25.5h after the end of pemetrexed infusion|PK set including patients with evaluable data||Litres||Geometric Coefficient of Variation|Geometric Mean
784419|NCT00824408|Secondary|CL of Pemetrexed|CL - total clearance of pemetrexed in plasma after IV administration|5 minutes before pemetrexed infusion, at the end of the infusion and 1.5 hours (h), 2.5h, 4.5h and 25.5h after the end of pemetrexed infusion|PK set including patients with evaluable data||mL/min||Geometric Coefficient of Variation|Geometric Mean
784420|NCT00824408|Secondary|Cmax of Pemetrexed|Cmax - maximum measured concentration of pemetrexed in plasma|5 minutes before pemetrexed infusion, at the end of the infusion and 1.5 hours (h), 2.5h, 4.5h and 25.5h after the end of pemetrexed infusion|PK set including patients with evaluable data||ng/mL||Geometric Coefficient of Variation|Geometric Mean
784421|NCT00824408|Secondary|Vss of Volasertib|Vss - apparent volume of distribution at steady state following IV administration of volasertib|5 minutes (min) before the start of Volasertib infusion and 1 hour (h), 2h, 4h, 24h, 168h and 336h after the start of Volasertib infusion|PK set including patients with evaluable data||Litres||Geometric Coefficient of Variation|Geometric Mean
784422|NCT00824408|Secondary|Total Clearance (CL) of Volasertib|CL - total clearance of volasertib in plasma after IV administration|5 minutes (min) before the start of Volasertib infusion and 1 hour (h), 2h, 4h, 24h, 168h and 336h after the start of Volasertib infusion|PK set including patients with evaluable data||mL/min||Geometric Coefficient of Variation|Geometric Mean
784423|NCT00824408|Secondary|Cmax of Volasertib|Cmax - maximum measured concentration of volasertib in plasma.|5 minutes (min) before the start of Volasertib infusion and 1 hour (h), 2h, 4h, 24h, 168h and 336h after the start of Volasertib infusion|Pharmacokinetic (PK) set, which included all patients in the treated set with volasertib monotherapy or combined with pemetrexed and provided at least 1 blood sample for measurement of volasertib (BI 6727) or pemetrexed. Including patients with evaluable data||ng/mL||Geometric Coefficient of Variation|Geometric Mean
784424|NCT00824408|Secondary|Frequency of Patients With Possible Clinically Significant Abnormalities|Frequency of patients with possible clinically significant abnormalities|From first drug infusion until 21 days after last drug infusion, up to 1100 days|On-treatment for lab||participants|||Number
784425|NCT00824408|Secondary|Occurence of DLT|"Occurence of Dose-limiting toxicity (DLT). A DLT was defined as one or more of the following:
treatment-related CTCAE Grade 3 or 4 nonhematological toxicity (except emesis or diarrhea responding to supportive treatment).
treatment-related CTCAE Grade 4 neutropenia for ≥7 days and/or complicated by infection.
CTCAE Grade 4 thrombocytopenia."|Patients were treated for repeated 21-day treatment cycles until disease progression or intolerability of the trial drug, whichever occurred first.|Treated set, run-in phase, first course only||participants|||Number
785107|NCT00835042|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma) of Moexipril.|Bioequivalence based on Cmax.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
784426|NCT00824408|Secondary|Occurrence and Intensity of AEs Graded According to CTCAE.|All patients were carefully monitored during and after each treatment cycle. Adverse events (AEs) were recorded and were graded according to the National Cancer Institute – Common Terminology Criteria for Adverse Events (CTCAE).|From first drug infusion until 21 days after last drug infusion, up to 1100 days|Treated set, which included all patients who were dispensed and were documented to have taken at least one dose of investigational treatment.||participants|||Number
784427|NCT00824408|Secondary|Duration of Overall Response|The duration of overall response was measured from the time measurement criteria were met for CR or PR (whichever was first recorded) until the first date that recurrent or progressive disease (PD) was objectively documented (taking as reference for PD the smallest measurements recorded since treatment began). The duration of overall CR was measured from the time measurement criteria were first met for CR until the first date that recurrent disease was objectively documented. Duration of disease control is presented here.|From the time measurement criteria were met for CR or PR (whichever was first recorded) until the first date that recurrent or progressive disease was objectively documented|Randomized phase II set||weeks||Inter-Quartile Range|Median
784428|NCT00824408|Secondary|Overall Survival (OS)|Overall survival (OS) was defined as the duration of time from randomization to time of death.|From randomization until time of death|Randomized phase II set, including only patients who died.||months||95% Confidence Interval|Median
784429|NCT00824408|Secondary|Objective Tumor Response, Defined as Complete Response (CR), and Partial Response (PR), Evaluated According to RECIST Criteria.|Objective tumor response, defined as complete response (CR), and partial response (PR), evaluated according to RECIST criteria. Evaluation of target lesions: Complete Response (CR): disappearance of all target lesions. Partial Response (PR): ≥30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Evaluation of nontarget lesions: Complete Response (CR): disappearance of all nontarget lesions.|From first drug infusion until 21 days after last drug infusion, up to 1100 days|Randomized set||percentage of participants|||Number
784430|NCT00824408|Primary|Progression Free Survival (PFS) Time From the Date of Randomization to Date of Disease Progression or Death, Whichever Occurred First.|"Disease progression was defined according to the Response Evaluation Criteria in Solid Tumours (RECIST)) criteria. Progression-free survival time was calculated as the duration from the date of randomization to the date of disease progression or death, whichever occured first. For patients with known date of progression (or death): PFS [days] = min (date of progression, date of death) - date of randomization + 1 day. For patients without progression or death, PFS was censored at the last imaging date that showed no disease progression: PFS [days, censored] = date of last imaging showing no progression - date randomization + 1 day.
The number of participants analysed displays the number of patients with an event (progression)."|From randomization until disease progression or death|Randomized phase II set, which included all patients who were randomized as part of phase II of the study (not the run in phase)||months||95% Confidence Interval|Median
784431|NCT00824421|Secondary|Plasma Concentration of Lersivirine at 24 Hour|The observed plasma concentration at 24 hours post-dose (C 24h).|24 hrs post-dose on Week 4|PKSSAS included all randomized Lersivirine participants who further consented to participate in the PK sub-study, received the study medication on the day of the PK sub-study and had sufficient PK data for analysis.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
784432|NCT00824421|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Lersivirine||0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 24 hrs post-dose on Week 4|PKSSAS included all randomized Lersivirine participants who consented to participate in the PK sub-study, received the study medication on the day of the PK sub-study and had sufficient PK data for analysis.||hr||Full Range|Median
784433|NCT00824421|Secondary|Maximum Observed Plasma Concentration (Cmax) of Lersivirine||0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 24 hrs post-dose on Week 4|PKSSAS included all randomized Lersivirine participants who consented to participate in the PK sub-study, received the study medication on the day of the PK sub-study and had sufficient PK data for analysis.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
784434|NCT00824421|Secondary|Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC[0-24]) of Lersivirine|AUC (0-24)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose (0-24). Only participants from Lersivirine treatment arms were planned to be analyzed for Pharmacokinetic (PK) sub-study.|0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 24 hours (hrs) post-dose on Week 4|Pharmacokinetic sub-study analysis set (PKSSAS) included all randomized Lersivirine participants who consented to participate in the PK sub-study, received the study medication on the day of the PK sub-study and had sufficient PK data for analysis.||nanogram*hour/milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
784435|NCT00824421|Secondary|Lersivirine Success Percentage With Reference to Median Minimum Observed Plasma Concentration (Cmin)|Simple quartile exposure analysis of success rate (viral load <50 copies/mL) versus median Cmin assesses the exposure response relationship. Percentage of participants with HIV-1 RNA level <50 copies/mL at median Cmin quartile were planned to be reported.|Week 2, 4, 8, 12, 16, 24, 32, 40, 48|Due to the sparsity of the data, it was deemed that the interpretation of the pharmacokinetic/pharmacodynamic (PK/PD) results would be questionable, thus data was not analyzed.|||||
784436|NCT00824421|Secondary|Population Pharmacokinetic (PK) of Lersivirine|Data for this outcome measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the participant flow and baseline characteristics modules.|Week 2, 4, 8, 12, 16, 24, 32, 40, 48||||||
784437|NCT00824421|Secondary|Number of Participants With Laboratory Test Abnormalities|Laboratory analysis included hematology, blood chemistry, serum and urine pregnancy test, hepatitis testing and urinalysis. Laboratory values that met the criteria of the Division of Acquired Immuno Deficiency Syndrome (DAIDS) grade 1 (mild, symptoms causing no or minimal interference with usual social and functional activities) or greater were considered as abnormal.|Baseline up to Week 96 or early termination|Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||participants|||Number
785118|NCT00835081|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
784438|NCT00824421|Secondary|Number of Participants With NRTI and NNRTI Resistance-Associated Mutations (RAMs) at Time of Treatment Failure Through Week 24, 48 and 96|Phenotypic resistance and genotypic resistance was assessed for all participants at Day 1 predose, and was evaluated for nucleotide reverse transcriptase inhibitors (NRTIs), and non-NRTIs (NNRTIs) resistance-associated mutations at time of treatment failure using Monogram GenoSeq and/or PhenoSenseGT assays. This was then repeated for all participants with HIV-1 viral load more than 500 copies/mL at treatment failure, up to Week 96.|Day 1 (pre-dose) through Week 24, 48, 96|Virology analysis set (TLOVR50 failures) included all participants who meet the TLOVR50 failure definition. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies participants evaluable for this measure at specified time point for each group, respectively.||participants|||Number
784439|NCT00824421|Secondary|Change From Baseline in Cluster of Differentiation (CD4+) Percentage Cell Count at Week 24, 48 and 96|Baseline value was calculated as the average of all the measurements collected prior to and including Day 1 pre-dose.|Baseline, Week 24, 48, 96|ITT population included all randomized participants who received at least 1 dose of study medication. LOCF method was used to impute missing values. No or zero change from baseline was imputed for participants with missing baseline or no CD4+ count available on treatment.||percentage of total lymphocytes||Standard Deviation|Mean
784440|NCT00824421|Secondary|Change From Baseline in Cluster of Differentiation (CD4+) Absolute Cell Count at Week 24, 48 and 96|Baseline value was calculated as the average of all the measurements collected prior to and including Day 1 pre-dose.|Baseline, Week 24, 48, 96|ITT population included all randomized participants who received at least 1 dose of study medication. LOCF method was used to impute missing values. No or zero change from baseline was imputed for participants with missing baseline or no CD4+ count available on treatment.||cells per microliter (cells/mcL)||Standard Deviation|Mean
784441|NCT00824421|Secondary|Percentage of Participants With Response as Determined Using the Time-to Loss of Virologic Response (TLOVR50) Algorithm at Week 24, 48 and 96|TLOVR50 response is compliment to TLOVR50 failure. TLOVR50 failure based on observed HIV-1 RNA levels and failure events (death; permanent discontinuation of drug; lost to follow-up; met treatment failure [TF] criteria). TF: an increase to at least 3 times baseline plasma HIV-1 RNA level at Week 2 or thereafter; failure to achieve HIV-1 RNA level <50 copies/mL at Week 24; starting at Week 2, an increase in HIV-1 RNA level to detectable levels (>50 copies/mL). TF criteria’s defined above were confirmed by second measurement at least 14 days after first. In 'TLOVR50', '50' denotes the lower limit of quantification (LLOQ) of assay (which is 50 copies/mL). Baseline value was calculated as the average of all the measurements collected prior to and including Day 1 pre-dose.|Week 24, 48, 96|ITT population included all randomized participants who received at least 1 dose of study medication. Missing value was imputed per the TLOVR algorithm.||percentage of participants|||Number
784442|NCT00824421|Secondary|Time-Averaged Difference (TAD) in Log 10 Transformed HIV-1 RNA Levels at Week 24, 48 and 96|TAD was calculated as area under the curve of HIV-1 RNA levels (log10 copies/mL) from baseline to the time point of interest divided by time period in weeks minus baseline HIV-1 RNA level (log10 copies/mL). Baseline value was calculated as the average of all the measurements collected prior to and including Day 1 pre-dose.|Baseline up to Week 24, 48, 96|ITT population. Participant discontinued before a visit of interest: value imputed as zero; not discontinued but observation was missing: value calculated to the last non-missing timepoint; not discontinued and missing values between baseline and visit: ignore missing values; missing baseline or no HIV-1 RNA level assessment: value imputed as zero.||log10 copies/mL||Standard Deviation|Mean
784443|NCT00824421|Secondary|Change From Baseline in Log 10 Transformed HIV-1 RNA Levels at Week 24, 48 and 96|For the log 10 scale, all the HIV-1 RNA levels were log 10 transformed prior to the average calculations. Baseline value was calculated as the average of all the measurements collected prior to and including Day 1 pre-dose.|Baseline, Week 24, 48, 96|ITT population. Participant discontinued before a visit of interest: value imputed as zero; not discontinued but observation is missing: Last observation carried forward (LOCF) imputation used; missing baseline or no HIV-1 RNA level assessment: value imputed as zero.||log 10 copies/mL||Standard Deviation|Mean
784444|NCT00824421|Secondary|Percentage of Participants With Less Than 400 Copies/mL of HIV-1 RNA at Week 24, 48 and 96|Plasma HIV-1 RNA level was determined by validated Roche Amplicor HIV-1 Monitor standard assay.|Week 24, 48, 96|ITT population included all randomized participants who received at least 1 dose of study medication. Participants who had been discontinued from the study, were lost to follow-up, or had missing HIV-1 RNA level data at a visit were considered to have HIV-1 RNA levels >=400 copies/mL and were referred to as non-completer = failure.||percentage of participants|||Number
784445|NCT00824421|Secondary|Percentage of Participants With Less Than 50 Copies/mL of HIV-1 RNA at Week 24 and 96|Plasma HIV-1 RNA level was determined by validated Roche Amplicor HIV-1 Monitor standard assay.|Week 24, 96|ITT population included all randomized participants who received at least 1 dose of study medication. Participants who had been discontinued from the study, were lost to follow-up, or had missing HIV-1 RNA level data at a visit were considered to have HIV-1 RNA levels >=50 copies/mL and were referred to as non-completer = failure.||percentage of participants|||Number
784446|NCT00824421|Primary|Percentage of Participants With Less Than 50 Copies Per Milliliter (Copies/mL) of Human Immunodeficiency Virus Type 1 Ribonucleic Acid (HIV-1 RNA) at Week 48|Plasma HIV-1 RNA level was determined by validated Roche Amplicor HIV-1 Monitor standard assay.|Week 48|ITT population included all randomized participants who received at least 1 dose of study medication. Participants who had been discontinued from the study, were lost to follow-up, or had missing HIV-1 RNA level data at a visit were considered to have HIV-1 RNA levels >=50 copies/mL and were referred to as non-completer = failure.||percentage of participants|||Number
784447|NCT00824434|Secondary|Technical Success|Successful delivery and deployment of the study stent to the target lesion, without balloon rupture or embolization, summarized per stent.|Acute-At time of index procedure|Intention to treat||percentage of stents attempted|Participants||Number
784448|NCT00824434|Secondary|Clinical Procedural Success|Mean lesion diameter stenosis < 30% with TIMI 3 flow without the occurrence of in-hospital cardiac death, MI, or TVR|Duration of hospital stay (usually 1-2 days)|Analysis was intention to treat||percentage of participants|||Number
784617|NCT00826540|Secondary|Response Rate|Simple frequency analysis will be conducted to see if response rate is related to prior treatment and the selected tumor biomarkers. Descriptive statistics will be used to investigate how prior treatment affects various other measures as well.|Up to 2 years||||||
784449|NCT00824434|Secondary|Definite + Probable Stent Thrombosis Based on Academic Research Consortium (ARC) Definition|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days).|>30 days-1 year|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
784450|NCT00824434|Secondary|Definite + Probable Stent Thrombosis Based on Academic Research Consortium (ARC) Definition|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days).|>24 hr-30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
784451|NCT00824434|Secondary|Definite + Probable Stent Thrombosis Based on Academic Research Consortium (ARC) Definition|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days).|24 hours|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
784452|NCT00824434|Secondary|Target Vessel Failure (TVF)|Target vessel failure (TVF) is defined as any ischemia-driven revascularization of the target vessel, myocardial infarction (MI, Q-wave and non–Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
784453|NCT00824434|Secondary|Target Lesion Failure (TLF)|Target lesion failure (TLF) is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non–Q-wave) related to the target vessel, or cardiac death related to the target vessel.|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
784454|NCT00824434|Secondary|Target Vessel Revascularization (TVR)|Target vessel revascularization (TVR) is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
784455|NCT00824434|Secondary|Target Vessel Revascularization (TVR)|Target vessel revascularization (TVR) is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.|30 Days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
784456|NCT00824434|Secondary|Target Lesion Revascularization (TLR)|Target lesion revascularization (TLR) is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.|12 Months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
784457|NCT00824434|Secondary|Target Lesion Revascularization (TLR)|Target lesion revascularization (TLR) is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.|30 Days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
784458|NCT00824434|Secondary|All-cause Mortality||12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
784459|NCT00824434|Secondary|Myocardial Infarction (MI)|New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase myoglobin band(CK-MB) or troponin >upper limit of normal(ULN); if no new Q-waves total CK levels >3×ULN (peri-percutaneous coronary intervention [PCI]) or >2×ULN (spontaneous) with elevated CK-MB or troponin >3×ULN (peri-PCI) or >2×ULN (spontaneous) plus ≥one of the following: ECG changes indicating new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5×ULN|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
784460|NCT00824434|Secondary|Occurance of Post-procedure Incomplete Stent Apposition|Percentage of participants who experience incomplete stent apposition as determined immediately post-procedure by intravascular ultrasound|Post-procedure|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device) and who underwent intravascular ultrasound to determine extent of stent apposition||percentage of participants|||Number
784461|NCT00824434|Secondary|In-stent Late Loss|In-stent late loss by quantitative coronary angiography in workhorse target lesions (visual reference vessel diameter [RVD] ≥2.5 mm and ≤4.25 mm and visual lesion length ≤24 mm)|9 months|Analysis was intention to treat; all patients in the study with workhorse lesions (visual reference vessel diameter [RVD] ≥2.5 mm and ≤4.25 mm and visual lesion length ≤24 mm) underwent clinical follow up to provide the information needed for this endpoint.||millimeters||Standard Deviation|Mean
784462|NCT00824434|Primary|Cardiac Events (Composite)|Percentage of patients who had a myocardial infarction, cardiac death, target lesion revascularization, or stent thrombosis (defined as definite or probable per the Academic Research Consortium [ARC] definitions); see below for definitions of individual components.|30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
784463|NCT00824460|Secondary|Change From Baseline in Serum-phosphate Levels at Week 5||5 weeks after baseline|"For this Secondary Outcome, FAS population was used, which consists of all randomized subjects who received at least 1 dose of study treatment and had at least 1 post-baseline efficacy evaluation (while on treatment).
Number of participants analyzed at this time point includes all subjects that had a serum-phosphate measurement at Week 5."||mmol/L||Standard Deviation|Mean
784464|NCT00824460|Secondary|Change From Baseline in Serum-phosphate Levels at Week 4||4 weeks after baseline|"For this Secondary Outcome, FAS was used, which consists of all randomized subjects who received at least 1 dose of study treatment and had at least 1 post-baseline efficacy evaluation (while on treatment).
Number of participants analyzed at this time point includes all subjects that had serum-phosphate measured at Week 4."||mmol/L||Standard Deviation|Mean
784465|NCT00824460|Secondary|Change From Baseline in Serum-phosphate Levels at Week 2||2 weeks after baseline|"For this Secondary Outcome, FAS was used, which consists of all randomized subjects who received at least 1 dose of study treatment and had at least 1 post-baseline efficacy evaluation (while on treatment).
Number of participants analyzed at this time point includes all subjects that had serum-phosphate measured at Week 2."||mmol/L||Standard Deviation|Mean
784466|NCT00824460|Primary|Change From Baseline in Serum-phosphate Levels at the End of Treatment.||6 weeks after baseline|For the Primary Outcome, data from the Full Analysis Set (FAS) was used. The FAS consists of all randomised subjects who received at least 1 dose of study treatment and had at least 1 post-baseline efficacy evaluation (while on treatment).||mmol/L||Standard Deviation|Mean
784467|NCT00824473|Secondary|Change From Baseline on Direct Visual Nasal Exams to 14 Days|Examination of head and neck (scale: None, Mild, Moderate, Severe) for Epistaxis, Mucosal Edema, Nasal Discharge, Mucosal erythema, Mucosal Bleeding, and Crusting of mucosa. Nasal irratation was rated: 0 = None, Grade 1A = focal irritation, Grade 1B = superficial mucosal erosion, Grade 2 = moderate mucosal erosion,Grade 3 = ulceration, Grade 4 = septal perforation|baseline and 14 days|||Participants|||Number
784468|NCT00824473|Secondary|Change From Baseline to Visit 4 in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Compared to Placebo in Subjects 18 Years of Age and Older|"A 28-item RQLQ was completed on Day 1 and Day 14 or Early temination. The RQLQ consists of 7 domains rated on a 7 point scale with 0 being not troubled by the allergy symptoms, and 6 being extremely troubled/all of the time.
Scores for a series of subsclaes are not combined for a total overall score, rather domain score will be calculated from the mean score of all items in the domain. Overall score will be calculated from the mean score of all items."|14 Days|||Units on a Scale||Standard Deviation|Least Squares Mean
784469|NCT00824473|Secondary|Change From Baseline in 12-hour Reflective Total Ocular Symptom Score and Instantaneous Total Ocular Symptom Score for the Entire 14-day Study Period Compared to Placebo (AM and PM Combined)|"reflective and instantaneous symptom scores (itchy eyes, watery eyes and red eyes) were assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible TOSS score is 9 per day.
Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate."|baseline to14 Days|||Scores on a scale||Standard Deviation|Least Squares Mean
784470|NCT00824473|Secondary|Change From Baseline in Instantaneous Total Nasal Symptom Score for the Entire 14-day Study Period Compared to Placebo (AM and PM Combined)|"instantaneous (subjects rate how they feel right now) total nasal symptom score consisting of runny nose, itchy nose, nasal congestion, and sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible score is 24 per day.
Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate."|baseline to 14 Days|||scores on a scale||Standard Deviation|Least Squares Mean
784471|NCT00824473|Secondary|Mean Change From Baseline in Instantaneous Total Nasal Symptom Sscore (AM) for the Entire 14-day Study Period Compared to Placebo|"End of 24 hour dosing interval: This endpoint is change from baseline in instantaneous (tNSS) for the 14-day study period compared to placebo to observe if the duration of efficacy lasts 24 hours on a day to day basis. Instantaneous tNSS consists of runny nose, itchy nose, nasal congestion, and sneezing. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe.
Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and baseline as a covariate."|baseline to 14 Days|||Score on a scale||Standard Deviation|Least Squares Mean
784472|NCT00824473|Primary|Change From Baseline in 12-hour Reflective Total Nasal Symptom Score(rTNSS)for the Entire 14-day Study Period Compared to Placebo (AM and PM Combined)at 14 Days|"rTNSS consisting of runny nose, itchy nose, nasal congestion, and sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. (maximum 12 points per assessment.) Total possible score is 24 per day.
Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate."|baseline and 14 days|||Scores on a scale||Standard Deviation|Least Squares Mean
784499|NCT00818116|Primary|Uncorrected and Best Corrected Visual Acuities (Near and Distance)|Measurement of uncorrected (without spectacles or other visual corrective devices) and best-corrected (with spectacles or other visual corrective devices)visual acuity at both near and distance. Visual Acuity (VA) is measured in logMAR. LogMAR is the “logarithm of the minimum angle of resolution”. A lower logMAR value indicates better visual acuity.|6 Months Following Cataract Surgery|||logMAR||Standard Deviation|Mean
784473|NCT00817531|Primary|Clinical Efficacy|The clinical response was assessed using RECIST and based on the changes in the longest diameter of the target lesion measured. Complete Response (CR), Disappearance of the target lesion; Partial Response (PR), >=30% decrease in the diameter of target lesion compared to baseline; Progressive disease (PD), >= 20% increase in the diameter of target lession, taking as reference the smallest diameter recorded since the baseline measurement or the appearance of new lesion; Stable disease (SD), neither sufficient shrinkage as PR or sufficient increase as PD.|Assessment at pre-surgery or 3 to 4 weeks of treatment.|All patients started the treatment will be included in the analysis||participants|||Number
784474|NCT00817596|Primary|Demonstrate That Prometra Programmable Pump System Accurately and Safely Delivers Medication in the Intrathecal Space, as Programmed.|"Accuracy was determined by calculation of the delivered to programmed drug volume (DP) ratio. The DP ratio was calculated as the ratio of delivered drug volume (the volumetrically determined delivered drug volume) to the programmed drug volume (the volume of drug that was programmed to be delivered) summed cumulatively for all fill/refills, including any unscheduled visits per patient.
The delivered drug volume over all (scheduled and unscheduled) valid fill/refill sessions was summed together per patient as the numerator and the programmed drug volume over all valid fill/refill sessions was summed together per patient as the denominator to provide a per-patient DP ratio."|6 months - acute study|Sample size was based on previous testing and data from similar devices. With a population of 60 subjects the 90% CI would be 95 ± 7, or 0.88 to 1.02. Therefore, approximately 60 patients with 6-months of data will provide adequate data to demonstrate accuracy, although up to 110 patients may be implanted to account for patient drop-outs.||% of programmed vol. actually delivered||90% Confidence Interval|Mean
784475|NCT00817778|Secondary|S-C-Peptide (AUC0-24)/24, Change From Baseline to End of Treatment|Log ratio (End of treatment/Baseline) has been analysed in a mixed-effect ANOVA model, using treatment as fixed effect and log(Baseline) as covariate. Resulting estimates have been back-transformed from the log-scale and then multiplied by 100 to obtain the relative ratio (end of treatment/placebo) in percent.|Baseline is the day before first dose, end of treatment is last day of treatment|||Relative ratio in percent||95% Confidence Interval|Least Squares Mean
784476|NCT00817778|Secondary|S-Insulin (AUC0-24)/24, Change From Baseline to End of Treatment|Log ratio (End of treatment/Baseline) has been analysed in a mixed-effect ANOVA model, using treatment as fixed effect and log(Baseline) as covariate. Resulting estimates have been back-transformed from the log-scale and then multiplied by 100 to obtain the relative ratio (end of treatment/placebo) in percent.|Baseline is the day before first dose, end of treatment is last day of treatment|||Relative ratio in percent||95% Confidence Interval|Least Squares Mean
784477|NCT00817778|Secondary|P-Glucose (AUC0-24)/24, Change From Baseline to End of Treatment|Log ratio (End of treatment/Baseline) has been analysed in a mixed-effect ANOVA model, using treatment as fixed effect and log(Baseline) as covariate. Resulting estimates have been back-transformed from the log-scale and then multiplied by 100 to obtain the relative ratio (end of treatment/placebo) in percent.|Baseline is the day before first dose, end of treatment is last day of treatment|||Relative ratio in percent||95% Confidence Interval|Least Squares Mean
784478|NCT00817778|Secondary|Apparent Oral Clearance of AZD1656||Measured last day of treatment|||L/h||Full Range|Geometric Mean
784479|NCT00817778|Secondary|Terminal Elimination Half-life of AZD1656||Measured following the afternoon dose last day of treatment|||h||Full Range|Geometric Mean
784480|NCT00817778|Secondary|Time to Reach Maximum Plasma Concentration of AZD1656||Measured last day of treatment|||h||Full Range|Median
784481|NCT00817778|Secondary|Maximum Plasma Concentration of AZD1656|Dose-adjusted to a morning dose of 50 mg due to titrated doses|Measured last day of treatment|||umol/L||Standard Deviation|Geometric Mean
784482|NCT00817778|Secondary|Area Under the Plasma Concentration vs Time Curve (AUC0-24) of AZD1656|Dose-adjusted to a total daily dose of 100 mg due to titrated doses|Measured last day of treatment|||umol*h/L||Standard Deviation|Geometric Mean
784483|NCT00817778|Primary|Clinically Relevant Change of Laboratory Variables|Number of participants with clinically relevant change of laboratory variables (clinical chemistry, haematology and urinalysis parameters|Measured regularly from day before first dose to day after last dose|||Participants|||Number
784484|NCT00817778|Primary|Weight, Change From Baseline to End of Treatment||Baseline is the day before first dose, end of treatment is last day of treatment|||kg||Standard Deviation|Mean
784485|NCT00817778|Primary|Pulse, Change From Baseline to End of Treatment||Baseline is pre-dose first day of dosing, end of treatment is the morning following the treatment period|||beats/min||Standard Deviation|Mean
784486|NCT00817778|Primary|Diastolic Blood Pressure, Change From Baseline to End of Treatment||Baseline is pre-dose first day of dosing, end of treatment is the morning following the treatment period|||mmHg||Standard Deviation|Mean
784487|NCT00817778|Primary|Systolic Blood Pressure, Change From Baseline to End of Treatment||Baseline is pre-dose first day of dosing, end of treatment is the morning following the treatment period|||mmHg||Standard Deviation|Mean
784488|NCT00817804|Secondary|Blood Pressure|Systolic and diastolic blood pressure|30 minutes||||||
784489|NCT00817804|Secondary|Heart Rate|Beats per minute that the patient's heart is beating|30 minutes||||||
784490|NCT00817804|Secondary|Minute Ventilation|Liters per minute that the patient breathes|30 minutes||||||
784491|NCT00817804|Secondary|Respiratory Rate|Breathing rate in breaths per minute|30 minutes||12/2011||||
784492|NCT00817804|Secondary|Saturation of Arterial Oxygen||30 minutes||12/2011||||
784493|NCT00817804|Primary|Breathing Comfort|Comfort on visual analog scale 0 - 100, 0 is best|30 minutes|Analysis was per protocol||visual analog scale||Standard Error|Mean
784494|NCT00817843|Primary|Treatment Difference in (Postprandial-Fasting) FMD|A comparison of the postprandial minus fasting change in FMD under treatment with simvastatin 80 mg versus simvastatin 10/10 mg|After 6 weeks of treatment|Analyses were performed in randomized patients who received ≥1 dose of study treatment and who had a post-randomization analysis measurement||% (change FMD)||Standard Error|Mean
784495|NCT00817843|Secondary|Preprandial Endopat Measurement||after 6 weeks of treatment (crossover)||||||
784496|NCT00817843|Secondary|Preprandial Endothelial Function Measured by FMD||after 6 weeks of treatment (crossover)||||||
784497|NCT00817843|Secondary|Postprandial Endopat Measurement||after 6 weeks of treatment (crossover)||||||
784498|NCT00817999|Primary|% Platelet Inhibition|% platelet inhibition measured by Verify Now|6 hours|||percentage of platelet inhibition||Standard Deviation|Mean
784500|NCT00818168|Secondary|Assessment of Disease Activity by Means of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at the Time of Enrollment and at the First Infusion|The BASDAI score was calculated based on the responses to questions 1-6, with each component rated on a scale of 0 (best) to 10 (worst) based on the severity of various characteristics. A decrease in BASDAI over time indicated improvement in disease activity. The score corresponded to the sum of the point values from questions 1-4 and the mean of the point values from questions 5 and 6, subsequently divided by five. BASDAI was calculated at the time of enrollment (baseline) and at the time of first infusion.|Baseline and time of first infusion|Data was analyzed for all AS patients whose data was entered into the database and finalized by signature of the physician.||Units on a scale||Standard Deviation|Mean
784501|NCT00818168|Primary|Number of Participants Who Had a Chest X-ray as Part of TB Screening for Active or Latent Tuberculosis Before Starting Treatment|"In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). If done according to guidelines, complete TB screening comprised a TB screening test and a chest X-ray. The number of participants who had a frontal chest X-ray was presented in three categories:
Yes
Missing"|Baseline|Data was analyzed for all AS patients whose data was entered into the database and finalized by signature of the physician.||Participants|||Number
784502|NCT00818168|Primary|Number of Participants Who Had the In-vitro TB Test as the First Screening Test for Active or Latent Tuberculosis Before Starting|"In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). The number of participants who had the in-vitro TB test (cellular blood test, i.e. gamma interferon release assays) as the first screening test was presented in three categories:
Yes
Missing (represents no entry, but may mean another test was performed as first screening test and documented)"|Baseline|Data was analyzed for all AS patients whose data was entered into the database and finalized by signature of the physician.||Participants|||Number
784503|NCT00818168|Primary|Number of Participants Who Had the Tine Test as the First Screening Test for Active or Latent Tuberculosis Before Starting Treatment|"In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). The number of participants who had the Tine test (multiple puncture tuberculin skin test) as the first screening test was presented in three categories:
Yes
Missing (represents no entry, but may mean another test was performed as first screening test and documented)"|Baseline|Data was analyzed for all AS patients whose data was entered into the database and finalized by signature of the physician.||Participants|||Number
784504|NCT00818168|Primary|Number of Participants Who Had the Mendel Mantoux Test as the First Screening Test for Active or Latent Tuberculosis (TB) Before Starting Treatment|"In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). The number of participants who had the Mendel Mantoux test (tuberculin sensitivity skin test by intradermal injection) as the first screening test was presented in three categories:
Yes
Missing (represents no entry, but may mean another test was performed as first screening test and documented)"|Baseline|Data was analyzed for all AS patients whose data was entered into the database and finalized by signature of the physician.||participants|||Number
784505|NCT00818207|Secondary|Percentage of Participants With Long Term Quit Rate (LTQR) Through Weeks 26 to 52|"LTQR was adjudicated if the following conditions were met: the participant self-reported tobacco abstinence for the previous 7 days with a negative response to the following questions: Have you smoked any cigarettes (even a puff) in the last 7 days? and Have you used any nicotine-containing product (such as chew, snuff, pipe, cigar) other than a NRT (SCT) in the last 7 days? and had no more than 6 cumulative days of using nicotine containing products from Weeks 26 to 52"|Week 26 to Week 52|ITT||Percentage of Participants|||Number
784506|NCT00818207|Secondary|Percentage of Participants With 7-Day PP of Abstinence at Week 13|"PP tobacco abstinence was adjudicated if the participant self-reported tobacco abstinence for the previous 7 days with a negative response to the following questions: Have you smoked any cigarettes (even a puff) in the last 7 days? and Have you used any nicotine-containing product (such as chew, snuff, pipe, cigar) other than a NRT (SCT) in the last 7 days?"|Week 13|ITT||Percentage of Participants|||Number
784507|NCT00818207|Secondary|Percentage of Participants With Continuous Abstinence (CA) at Weeks 26, 39, and 52|"CA from smoking was adjudicated if the following conditions were met:(a) self-reported continuous tobacco abstinence during the defined time point with a negative response to the questions Have you smoked any cigarettes (even a puff) since the last contact/visit? at every visit from Week 26 through Week 52 (Weeks 26, 39, and 52) and Have you used any nicotine-containing product (such as chew, snuff, pipe, cigar) other than an NRT (SCT) since the last contact/visit? and (b) urine cotinine test results were neither positive (greater than or equal to [≥]200 ng/mL) nor missing."|Week 26, Week 39, and Week 52|ITT||Percentage of Participants|||Number
784508|NCT00818207|Secondary|Percentage of Participants With Biochemically Confirmed 7-Day PP Abstinence From Tobacco|"PP tobacco abstinence was adjudicated if the following conditions were met:(a) self-reported tobacco abstinence for the previous 7 days with a negative response to the questions Have you smoked any cigarettes (even a puff) in the last 7 days? and Have you used any nicotine-containing product (such as chew, snuff, pipe, cigar) other than an NRT (SCT) in the last 7 days? confirmed by negative urine cotinine test results (defined as cotinine levels less than [<]200 nanograms per milliliter [ng/mL])."|Week 26|ITT||Percentage of Participants|||Number
784509|NCT00818207|Primary|Percentage of Participants With 7-Day Point Prevalence (PP) of Abstinence|"Percentage of participants who self-reported tobacco abstinence for the previous 7 days (7-day PP) with a negative response to the following questions: Have you smoked any cigarettes (even a puff) in the last 7 days? and Have you used any nicotine-containing product (such as chew, snuff, pipe, cigar) other than a Nicotine Replacement Therapy (NRT) (smoking cessation treatment [SCT]) in the last 7 days?"|Week 26|Intent to Treat (ITT) Population: all randomized participants||Percentage of Participants|||Number
784510|NCT00818246|Secondary|Number of Adverse Events.|Signs of erythema, edema, scaling/crusting, bronzing, textural changes, hyperpigmentation, and hypopigmentation were monitored.|Adverse reactions were monitored throughout the study and up to 4 weeks.|Intention to treat (ITT)||Number of adverse events|||Number
784511|NCT00818246|Primary|Percent Change From Baseline in Microtopographic Profilometry Rz Values (Rhytid Depth and Severity.|Phaseshift Rapid In vivo Measurement Of Skin (PRIMOS) readings. Analysis of the data in the image is used to generate Microtopographic profilometry Rz values (peak to valley analysis) to quantify rhytid depth and severity.|Baseline and 4 weeks|Per Protocol||Percent change post-treatment||95% Confidence Interval|Mean
784512|NCT00818246|Secondary|Change From Baseline in Units on the Fitzpatrick Classification System (FCS) Scale for Degree of Wrinkling.|Clinical qualitative assessment was performed by three blinded medical observers through the evaluation of digital photographs. The photographs were analyzed for clinical improvement using the Fitzpatrick Classification System (FCS)subtype scale for degree of wrinkling (rhytids). Their assessment was rated on a five-point scale and scored as follows; 0=none; 1=mild; 2=moderate; 3=good; 4=excellent.|Baseline and 4 weeks|Per Protocol||Change in units on the FCS scale||95% Confidence Interval|Mean
784513|NCT00818246|Primary|Percent Change From Baseline in Microtopographic Profilometry Ra Values (Skin Roughness).|Phaseshift Rapid In vivo Measurement Of Skin (PRIMOS) readings. Analysis of the data in the image is used to generate Microtopographic profilometry Ra values (skin surface roughness).|Baseline and 4 weeks|Per Protocol||Percent change post-treatment||95% Confidence Interval|Mean
784514|NCT00818259|Primary|Number of Participants Discontinuing Study Drug Due to an AE|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. The number of participants who discontinued from the study due to an AE are summarized.|Day 1 up to Day 3|The ASaT population consisted of all randomized participants who received at least one dose of study drug.||Participants|||Number
784515|NCT00818259|Secondary|Plasma Concentration and PK Parameters of Dexamethasone in Participants From Birth to 1 Year of Age|Blood samples for PK assessment were to be collected at the following time points: Parts II and V - Pre-dose and 1.5, 3, 4, 6, 8 and 24 hr post start of chemotherapy; Parts III and IV - Immediately after infusion of dexamethsone and 0.5, 1.5, 3, 8 and 24 hr post start of chemotherapy.|Up to 24 hours post dexamethasone dose|This population was to consist of all participants from birth to 1 year of age who received at least one dose of dexamethasone and were evaluable for this PK parameter. These analyses were not conducted; enrollment of this cohort was not opened as enrollment of participants from birth to <6 months of age into Part II was unsuccessful.|||||
784516|NCT00818259|Primary|Number of Participants Experiencing Adverse Events (AEs)|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Participants were monitored for the occurrence AEs for up to 14 days after last dose of study drug.|Up to 14 days after last dose of study drug (Up to 17 days)|The All Subjects as Treated (ASaT) population consisted of all randomized participants who received at least one dose of study drug.||Participants|||Number
784517|NCT00818259|Primary|Tmax for Fosaprepitant|Tmax is a measure of the amount of time after dosing to when the maximum concentration of fosaprepitant was achieved. Blood samples for PK assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hr post fosaprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy.|Up to 72 hours post fosaprepitant dose|The population consisted of all participants who received at least one dose of fosaprepitant & were evaluable for this PK parameter. No PK analyses were performed on the Part 1A-fosaprepitant 115 mg/aprepitant group; blood samples from this group were not handled correctly. Part IIA, Part IIB, Part III & Part IV groups received no fosaprepitant.||hr||Standard Deviation|Mean
784518|NCT00818259|Primary|Cmax for Fosaprepitant|Cmax is a measure of the maximum amount of fosaprepitant in the plasma. Blood samples for PK assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hr post fosaprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy.|Up to 72 hours post fosaprepitant dose|The population consisted of all participants who received at least one dose of fosaprepitant & were evaluable for this PK parameter. No PK analyses were performed on the Part 1A-fosaprepitant 115 mg/aprepitant group; blood samples from this group were not handled correctly. Part IIA, Part IIB, Part III & Part IV groups received no fosaprepitant.||ng/mL||Standard Deviation|Mean
784519|NCT00818259|Primary|Apparent Terminal Half-life (t1/2) for Aprepitant|t1/2 is the amount of time from dosing until half of the aprepitant was metabolized from the body. Fosaprepitant is a prodrug for aprepitant and is rapidly converted to aprepitant after IV administration. Blood samples for PK assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hr post fosaprepitant dose; Part IB - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy; Parts II and IV - Pre-dose and 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post aprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy.|Up to 72 hours post fosaprepitant/aprepitant dose|The population consisted of all participants who received at least one dose of fosaprepitant and/or aprepitant and were evaluable for this PK parameter. No PK assessements were performed on the Part III-ondansetron group; this group received no aprepitant.||hr||Standard Deviation|Mean
784520|NCT00818259|Primary|Time to Cmax (Tmax) for Aprepitant|Tmax is a measure of the amount of time after dosing to when the maximum concentration of aprepitant was achieved. Fosaprepitant is a prodrug for aprepitant and is rapidly converted to aprepitant after IV administration. Blood samples for PK assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hr post fosaprepitant dose; Part IB - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy; Parts II and IV - Pre-dose and 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post aprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy.|Up to 72 hours post fosaprepitant/aprepitant dose|The population consisted of all participants who received at least one dose of fosaprepitant and/or aprepitant and were evaluable for this PK parameter. No PK assessements were performed on the Part III-ondansetron group; this group received no aprepitant.||hr||Standard Deviation|Mean
784532|NCT00818389|Secondary|Vital Capacity (VC) (Percent of Predicted Normal)|Secondary efficacy was measured by comparing the rate of decline of mean VC by treatment group.|9 months: Baseline to study termination (January 2009- October 2009)|||Percent of predicted normal||Standard Error|Mean
784521|NCT00818259|Primary|Maximum Plasma Concentration (Cmax) for Aprepitant|Cmax is a measure of the maximum amount of aprepitant in the plasma. Fosaprepitant is a prodrug for aprepitant and is rapidly converted to aprepitant after IV administration. Blood samples for PK assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hr post fosaprepitant dose; Part IB - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy; Parts II and IV - Pre-dose and 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post aprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy.|Up to 72 hours post fosaprepitant/aprepitant dose|The population consisted of all participants who received at least one dose of fosaprepitant and/or aprepitant and were evaluable for this PK parameter. No PK assessements were performed on the Part III-ondansetron group; this group received no aprepitant.||ng/mL||Standard Deviation|Mean
784522|NCT00818259|Primary|Area Under the Time-Concentration Curve From 0 to 24 Hours (AUC 0-24hr) for Aprepitant|AUC is a measure of the amount of aprepitant in the plasma. Fosaprepitant is a prodrug for aprepitant and is rapidly converted to aprepitant after IV administration. Blood samples for pharmacokinetic (PK) assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hours (hr) post fosaprepitant dose; Part IB - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8 and 24 hr post start of chemotherapy; Parts II and IV - Pre-dose and 1.5, 3, 4, 6, 8 and 24 hr post aprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 1.5, 3, 4, 6, 8 and 24 hr post start of chemotherapy.|Up to 24 hours post fosaprepitant/aprepitant dose|The population consisted of all participants who received at least one dose of fosaprepitant and/or aprepitant and were evaluable for this PK parameter. No PK assessements were performed on the Part III-ondansetron group; this group received no aprepitant.||hr*ng/mL||Standard Deviation|Mean
784523|NCT00818272|Primary|Number of Participants Who Had a Chest X-ray as Part of TB Screening for Active or Latent Tuberculosis Before Starting Treatment|"In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). If done according to guidelines, complete TB screening comprised a TB screeing test and a chest X-ray. The number of participants who had a frontal chest X-ray was presented in three categories:
Yes
Missing"|Baseline|||Participants|||Number
784524|NCT00818272|Primary|Number of Participants Who Had the In-vitro TB Test as the First Screening Test for Active or Latent Tuberculosis Before Starting Treatment|"In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). The number of participants who had the in-vitro TB test (cellular blood test, i.e. gamma interferon release assays) as the first screening test was presented in three categories:
Yes
Missing (represents no entry, but may mean another test was performed as first screening test and documented)"|Baseline|||Participants|||Number
784525|NCT00818272|Primary|Number of Participants Who Had the Tine Test as the First Screening Test for Active or Latent Tuberculosis Before Starting Treatment|"In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). The number of participants who had the Tine test (multiple puncture tuberculin skin test) as the first screening test was presented in three categories:
Yes
Missing (represents no entry, but may mean another test was performed as first screening test and documented)"|Baseline|||Participants|||Number
784526|NCT00818272|Secondary|Assessment of Disease Activity by Means of the Crohn's Disease Activity Index (CDAI) at the Time of Enrollment and at the First Infusion|The CDAI score is used to quantify the symptoms of participants with CD. The CDAI incorporates 8 items added together that are indicators of disease severity. Scores range from 0 to 600; higher scores indicate worse disease activity. Participants with scores below 150 have inactive disease whereas those with scores above 450 are considered critically ill. A decrease in CDAI over time indicates improvement in disease activity. CDAI was calculated at the time of enrollment (baseline) and at the time of first infusion.|Baseline and time of first Infusion|Data was analyzed for all CD participants whose data had been entered in the database and finalized by signature of the physician. 90 out of 148 participants available at enrollment completed the CDAI and 42 out of the 128 available participants at first infusion after screening (beginning of 2 year observation period) completed the CDAI.||Score on a scale||Standard Deviation|Mean
784527|NCT00818272|Primary|Number of Participants Who Had the Mendel Mantoux Test as the First Screening Test for Active or Latent Tuberculosis (TB) Before Starting Treatment|"In order to increase the attending physician’s awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). The number of participants who had the Mendel Mantoux test (tuberculin sensitivity skin test by intradermal injection) as the first screening test was presented in three categories:
Yes
Missing (represents no entry, but may mean another test was performed as first screening test and documented)"|Baseline|||Participants|||Number
784528|NCT00818324|Other Pre-specified|Change From Baseline (CFB) in Lissamine Green Conjunctival Staining (LGCS) Score|LGCS indicates the damage to the conjunctival epithelium. Per the National Eye Institute/Industry Workshop report, the conjunctiva was divided into 6 fractions, each of which was given a staining score from 0 to 3, and the total score was calculated (0-18). 0 is better. Baseline scores and those obtained at each examination time point were compared (paired t-test).|Baseline, Week2, Week4, Week28, Week52|||LGCS score||Standard Deviation|Mean
784529|NCT00818324|Primary|Change From Baseline (CFB) in Fluorescein Corneal Staining (FCS) Score|FCS indicates the damage to the corneal epithelium. Per the National Eye Institute/Industry Workshop report, the cornea was divided into 5 fractions, each of which was given a staining score from 0 to 3, and the total score was calculated (0-15). 0 is better. Baseline scores and those obtained at each examination time point were compared (paired t-test).|Baseline, Week2, Week4, Week28, Week52|||FCS score||Standard Deviation|Mean
784530|NCT00818337|Secondary|Number of Aspirin Resistant Who Became Responders After Increase to Aspirin 325 mg|Aspirin resistance was defined as ARU > 550|2 weeks|||participants|||Number
784531|NCT00818337|Primary|Number of Women Aspirin Resistant|Aspirin responsive unit (ARU) > 550 was considered to be aspirin resistant and correlates to less than 50% inhibition of platelet aggregation.|Baseline|||participants|||Number
784533|NCT00818389|Primary|Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised Questionnaire (ALSFRS-R)|ALSFRS-R is a self-administered ordinal rating scale questionnaire (rating 0-4 for each question,4 is most functional,0-48 total)of 12 functional activities. The most functional total score is 48. ALSFRS-R done at baseline and weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 & 52, dependent on enrollment duration. Number of subjects who failed by treatment group was evaluated. Failure was defined as 6-point drop in ALSFRS-R or death from baseline.|9 months: Baseline to study termination (January 2009 - October 2009)|||Participants|||Number
784534|NCT00818389|Secondary|Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised Questionnaire(ALSFRS-R)|ALSFRS-R is a self-administered ordinal rating scale questionnaire (rating 0-4 for each question,4 is most functional,0-48 total)of 12 functional activities. The most functional total score is 48. ALSFRS-R done at baseline and weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 & 52, dependent on enrollment duration. Secondary efficacy was evaluated by comparing the mean rate of decline of ALSFRS-R score by treatment group.|9 months: Baseline to study termination (January 2009 - October 2009)|||Scores on a scale||Standard Error|Mean
784535|NCT00824512|Secondary|Visual Assessment Scale (VAS) of Global Impression - Investigator|The VAS used a 10-cm scoring scale in which values were reported in mm such that 0=bad and 100=good. Total score range on VAS is from 0 to 100.|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.||mm||Full Range|Median
784536|NCT00824512|Secondary|Visual Assessment Scale (VAS) of Global Impression - Parents|The VAS used a 10-cm scoring scale in which values were reported in mm such that 0=bad and 100=good. Total score range on VAS is from 0 to 100.|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.||mm||Full Range|Median
784537|NCT00824512|Secondary|Visual Assessment Scale (VAS) of Global Impression - Patient|The VAS used a 10-cm scoring scale in which values were reported in mm such that 0=bad and 100=good. Total score range on VAS is from 0 to 100.|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.||mm||Full Range|Median
784538|NCT00824512|Secondary|Choice Reaction Time Test- Movement Time|The choice reaction time test was used to assess cognitive functioning. On random presentation of one of six signal lights, the patient was asked to respond as quickly and accurately as possible by removing their index finger of the dominant hand from the bottom key and pressing whichever of the top six keys was indicated by the signal. Reaction time was the time elapsed between the presentation of the stimulus and the release of the finger and movement time was defined as the time elapsed between release of the finger and pressure of the second key.|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.||millisecond||Full Range|Median
784539|NCT00824512|Secondary|Choice Reaction Time Test- Reaction Time|The choice reaction time test was used to assess cognitive functioning. On random presentation of one of six signal lights, the patient was asked to respond as quickly and accurately as possible by removing their index finger of the dominant hand from the bottom key and pressing whichever of the top six keys was indicated by the signal. Reaction time was the time elapsed between the presentation of the stimulus and the release of the finger and movement time was defined as the time elapsed between release of the finger and pressure of the second key.|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.||millisecond||Full Range|Median
784540|NCT00824512|Secondary|Nine Hole Peg Test (Nondominant Hand)|The nine hole peg test was used to assess cognitive function and in particular, fine motor coordination. The patient was asked to place nine pegs in nine holes and was scored on the amount of time it took to place and remove all nine pegs.|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.||seconds||Full Range|Median
784541|NCT00824512|Secondary|Nine Hole Peg Test (Dominant Hand)|The nine hole peg test was used to assess cognitive function and in particular, fine motor coordination. The patient was asked to place nine pegs in nine holes and was scored on the amount of time it took to place and remove all nine pegs.|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.||seconds||Full Range|Median
784542|NCT00824512|Secondary|Timed 25-foot Walk Test||Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.||seconds||Full Range|Median
784543|NCT00824512|Secondary|ICARS (Oculomotor Disorders Score)|The ICARS was used to measure the general clinical symptoms of Friedreich ataxia using four subscales including Oculomotor Disorders. Oculomotor Disorders score range from 0 to 6 (Higher scores indicate higher levels of impairment).|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.||score on a scale||Full Range|Median
785119|NCT00835081|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
784544|NCT00824512|Secondary|ICARS (Speech Disorders Score)|The ICARS was used to measure the general clinical symptoms of Friedreich ataxia using four subscales including Speech Disorders. Speech Disorders Score range from 0 to 8 (Higher scores indicate higher levels of impairment).|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.||score on a scale||Full Range|Median
784545|NCT00824512|Secondary|ICARS (Kinetic Function Score)|The ICARS was used to measure the general clinical symptoms of Friedreich ataxia using four subscales including Kinetic Function. Kinetic Function score range from 0 to 52 (Higher scores indicate higher levels of impairment).|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.||score on a scale||Full Range|Median
784546|NCT00824512|Secondary|ICARS (Posture and Gait Disturbance Score)|The ICARS was used to measure the general clinical symptoms of Friedreich ataxia using four subscales including Posture and gait disturbances. Posture and gait disturbances score range from 0 to 34 (Higher scores indicate higher levels of impairment).|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.||score on a scale||Full Range|Median
784547|NCT00824512|Secondary|International Cooperative Ataxia Rating Scale [ICARS] (Total Score)|The ICARS was used to measure the general clinical symptoms of Friedreich ataxia using four subscales (i.e. Posture and gait disturbances, Kinetic functions, Speech disorders, & Oculomotor disorders). Scores for each subscale quantify the extent of ataxia in each clinically important area and subscale scores are also summed to give a total score ranging from 0 to 100, with 100 indicative of the most severely affected outcome.|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.||score on a scale||Full Range|Median
784548|NCT00824512|Secondary|Metabolism Efficacy Index|The metabolism efficacy index was derived as Normalised work x creatine phosphorylation rate (sec-1). [Normalised work was derived as Work developed during the exercise/(60 X Maximum cross section of muscle-1100)]. Greater values of Metabolism Efficacy index indicate improvement in skeletal muscle energetics while lower values indicate the reverse. Negative values obtained using the formula indicated severe levels of muscle weakness.|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.||per second||Full Range|Median
784549|NCT00824512|Secondary|Normalised Work Developed During the Exercise|"Normalised work developed during the exercise was derived as Work developed during the exercise/([60 X Maximum cross section of muscle]-1100).
Normalised work measured using Phosphorus 31 Nuclear Magnetic Resonance (P-31 NMR)spectroscopy."|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.||Joules/cm^2||Full Range|Median
784550|NCT00824512|Secondary|Developed Force During the Exercise Bout|Developed force during the exercise bout measured using Phosphorus 31 Nuclear Magnetic Resonance (P-31 NMR)spectroscopy|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.||Joules||Full Range|Median
784551|NCT00824512|Secondary|Muscle Trophicity: Maximum Cross Section of Muscle|Muscle trophicity measured using Phosphorus 31 Nuclear Magnetic Resonance (P-31 NMR)spectroscopy and calculated based on maximum cross section of muscle (cm^2)|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.||cm^2||Full Range|Median
784552|NCT00824512|Secondary|Muscle Reoxygenation Rate Post Exercise.|Muscle reoxygenation rate post exercise was assessed using Myoglobin Hydrogen-1 Nuclear Magnetic Resonance spectroscopy.|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.||per second||Full Range|Median
784553|NCT00824512|Secondary|Perfusion-time Integral During the First 9 Minutes Post Exercise.|The integral of 'peak perfusion' over a period of 9 minutes post exercise.|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.||mL/100 g of tissue||Full Range|Median
784554|NCT00824512|Secondary|Time to Peak Perfusion||Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.||seconds||Full Range|Median
784555|NCT00824512|Secondary|Peak Post Exercise Perfusion|Peak post exercise perfusion (mL/mn/100 g of tissue) was assessed using Arterial spin labelling combined with Nuclear Magnetic Resonance imaging.|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.||ml/mn/100 g of tissue||Full Range|Median
784556|NCT00824512|Primary|Creatine Rephosphorylation Rate Post Exercise|Creatine Rephosphorylation Rate post exercise measured using Phosphorus 31 Nuclear Magnetic Resonance (P-31 NMR)spectroscopy and calculated with correction according to muscular pH.|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.||pH per second||Full Range|Median
784557|NCT00824538|Secondary|Effect of Sunitinib Malate on OTC in Peripheral Blood||one year||||||
784558|NCT00824538|Secondary|Relapse-free and Overall Survival||up to 3 years||12/2013||||
784559|NCT00824538|Secondary|Participants Affected by Toxicities as Assessed by NCI CTCAE v3.0||up to 7 months|||participants|||Number
784560|NCT00824538|Secondary|Number of Patients Who Are Able to Tolerate Sunitinib Malate for 6 Months and Complete the Study||6 months|||participants|||Number
784561|NCT00824538|Primary|Percent Change From Baseline in Disseminated Tumor Cells (DTC) in Bone Marrow|DTCs were detected by immunomagnetic enrichment and flow cytometry (IE/FC) and measured in cells/mL|Baseline, 6 months|||percentage of change||Full Range|Mean
784562|NCT00824564|Secondary|Number of Participants With Deep Vein Thrombosis (DVT) Post Surgery|DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling and warmth.|Day 5 post-surgery|FAS included all participants who were randomized to study treatment and received at least one dose of study medication.||Participants||95% Confidence Interval|Number
784563|NCT00824564|Secondary|Change From Baseline in Hemoglobin Levels at End of Surgery, 1 hr Post-surgery, and Mornings of Day 1, Day 2, Day 4, Day 7 or Early Termination (ET) Post-surgery||Baseline through end of surgery, 1 hr post-surgery, and mornings of Day 1, Day 2, Day 4, Day 7 or ET post-surgery|FAS included all participants who were randomized to study treatment and received at least one dose of study medication.||gram/deciliter (g/dl)||Standard Deviation|Mean
784564|NCT00824564|Secondary|Number of Participants Receiving Transfusions|A uniform transfusion protocol was maintained for all participants in the study. Transfusion to be triggered at 8.0 milligram/deciliter (mg/dl) hemoglobin or haematocrit value of 24 percent.|Up to day 7 post-surgery|FAS included all participants who were randomized to study treatment and received at least one dose of study medication.||Participants||95% Confidence Interval|Number
784565|NCT00824564|Secondary|Total Blood Loss Assessed by Gross’ Formula|Gross’s formula for estimating total blood loss: Estimated blood volume*[(Hematocrit initial - Hematocrit final)/ Hematocrit average]; where estimated blood volume equals body weight in kilograms (kg) *70 mL/kg.|Day 7 post-surgery|FAS included all participants who were randomized to study treatment and received at least one dose of study medication.||mL||Standard Deviation|Mean
784566|NCT00824564|Secondary|Post-operative Blood Loss|Post-operative blood loss was defined as the sum of the drainage volumes measured over post-operative days 1, 2, and at drain removal. It was measured by weighing the drapes/ dressings or swabs prior to soaking to measure difference in weight and checking drain collectors until drains were removed.|1, 4, 8 and 24 hours post-surgery|FAS included all participants who were randomized to study treatment and received at least one dose of study medication.||mL||Standard Deviation|Mean
784567|NCT00824564|Secondary|Intra-operative Blood Loss|Intra-operative blood loss was measured by weighing the drapes/ dressings or swabs prior to soaking to measure difference in weight and checking drain collectors until drains were removed.|Day 1 (End of surgery)|FAS included all participants who were randomized to study treatment and received at least one dose of study medication.||mL||Standard Deviation|Mean
784568|NCT00824564|Primary|Total Blood Loss|Total blood loss was defined as the sum of intra-operative and post-operative blood loss. It was measured by weighing the drapes/ dressings or swabs prior to soaking to measure difference in weight and checking drain collectors until drains were removed.|Baseline through Day 7 post-surgery|Full analysis set (FAS) included all participants who were randomized to study treatment and received at least one dose of study medication.||Milliliters (mL)||Standard Deviation|Mean
784569|NCT00824616|Primary|Number of Participants Who Experienced One or More Episodes of Hypoglycemia (Symptomatic or Asymptomatic)|Hypoglycemic episodes - with or without symptoms - are defined as a fingerstick glucose measurement of ≤70 mg/dL (3.9 mmol/L). Excludes data after initiation of glycemic rescue therapy.|From first dose of study drug (Week 0) to last dose of study drug (Week 20)|All Participants as Treated Population, which consisted of all randomized participants who took at least one dose of study drug (MK-0941 or Placebo).||participants|||Number
784570|NCT00824616|Primary|Change From Baseline in Hemoglobin A1c (HbA1c) Level|HbA1c level is a blood test measurement of the amount (percent) of hemoglobin that is glycated (or has glucose on it). HbA1c level is related to the average blood glucose concentration over the previous 2-3 months, with a higher HbA1c level indicating a higher amount of average plasma glucose. A negative number for change from baseline in HbA1c level means a reduction in HbA1c level and indicates better control of average plasma glucose levels.|Baseline (Day 1) and End of Treatment (Week 20)|Full Analysis Set Population, which consisted of all randomized participants who took at least one dose of study drug (MK-0941 or Placebo) and had a baseline or post-randomization measurement.||% HbA1c||95% Confidence Interval|Least Squares Mean
784571|NCT00824655|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 7 Days of the Toddler Dose (12 Months of Age)|Systemic events (any fever ≥ 38 degrees C, decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may have been represented in more than 1 category.|Day 1 through 7 after vaccination|Safety Population; n = number of participants reporting yes for at least 1 day or no for all days for the specific characteristic||Percentage of participants|||Number
784572|NCT00824655|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 7 Days of the Infant Dose (5 Months of Age)|Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may have been represented in more than 1 category.|Day 1 through 7 after vaccination|Safety Population; n = number of participants reporting yes for at least 1 day or no for all days for the specific characteristic||Percentage of participants|||Number
784573|NCT00824655|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days of the Toddler Dose (12 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may have been represented in more than 1 category.|Day 1 through Day 7 after vaccination|Safety Population; n = number of participants reporting yes for at least 1 day or no for all days for the specific characteristic||Percentage of participants|||Number
784574|NCT00824655|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (5 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may have been represented in more than 1 category.|Day 1 through Day 7 after vaccination|Safety Population: all participants who received at least 1 dose of the study vaccine; n = number of participants reporting yes for at least 1 day or no for all days for the specific characteristic||Percentage of participants|||Number
784575|NCT00824655|Secondary|GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured Before the Toddler Dose|Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) presented. GMC (13vPnC) and corresponding 2-sided 95% CIs evaluated. GMCs calculated using all participants with available data for the specified blood draw.|12 months of age (prior to toddler dose)|Evaluable Toddler Immunogenicity Population||mcg/mL||95% Confidence Interval|Geometric Mean
784576|NCT00824655|Secondary|GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured 1 Month After the Infant Dose|Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. GMCs calculated using all participants with available data for the specified blood draw.|1 Month after the infant series (6 months of age)|Evaluable Infant Immunogenicity Population||mcg/mL||95% Confidence Interval|Geometric Mean
784577|NCT00824655|Secondary|Percentage of Participants Achieving a Serotype-specific IgG Antibody Greater Than or Equal To (≥) 0.35 Mcg/mL, 1 Month After the Infant Dose|Percentage of participants achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.|1 Month after the infant series (6 months of age)|Evaluable Infant Immunogenicity Population: eligible participants who received study vaccine at the expected dose(s), blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations.||Percentage of participants||95% Confidence Interval|Number
784578|NCT00824655|Primary|Geometric Mean Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose|Antibody geometric mean concentration (GMC) as measured by micrograms per milliliter (mcg/mL) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. GMCs were calculated using all participants with available data for the specified blood draw.|1 month after the toddler dose (13 months of age)|Evaluable Toddler Immunogenicity Population: eligible participants who received study vaccine at the expected dose(s), blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations.||mcg/mL||95% Confidence Interval|Geometric Mean
784579|NCT00824720|Primary|Visual Acuity - Left Eye|This outcome measures visual acuity in logMARs. logMAR is the logarithm of the minimum angle of resolution (logMAR. The ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.|at 14 days|||logMARs||Standard Deviation|Mean
784580|NCT00824720|Primary|Visual Acuity - Right Eye|This outcome measures visual acuity in logMARs. logMAR is the logarithm of the minimum angle of resolution (logMAR). The ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.|at 14 days|||logMAR units||Standard Deviation|Mean
784581|NCT00824720|Secondary|Intraocular Pressure (IOP)||from baseline to 14 days|The analysis population includes all subjects with a plug insertion that completed the study per protocol.||mmHg||Standard Deviation|Mean
784582|NCT00824733|Secondary|Combination of PF-03512676 and Trastuzumab Induces MIP-1 (Macrophage Inflammatory Protein 1), MCP-1 (Monocyte Chemoattract Protein 1) and RANTES.||up to 18 weeks|The study was terminated early due to poor patient accrual and no data was collected and analyzed.|||||
784583|NCT00824733|Secondary|Progression-free Survival for Patients With Metastatic Breast Cancer That Are Receiving Trastuzumab Plus PF-03512676|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|up to 18 weeks|||weeks||Full Range|Median
784584|NCT00824733|Primary|PF-03512676 Augments Antibody Mediated Cytoxicity (ADCC)Against Trastuzumab-coated Target Cells in Metastatic HER2 Overexpressing Breast Cancer.||up to 18 weeks|Samples were not analyzed for primary endpoint due to the sample numbers being too small. No data were collected from the samples.|||||
784585|NCT00824746|Secondary|Overall Survival||2 years|||days||95% Confidence Interval|Median
784586|NCT00824746|Primary|Disease Control(DC) Rate of Gefitinib Retreatment Per RECIST Criteria (V1.1) and Assessed by CT|Evaluation of treatment response by computed tomography (CT) was performed after the first 4 weeks according to version 1.1 of the guidelines set out by Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Disease control rate (DCR) was defined as the percentage sum of best tumor response of complete response (CR), partial response (PR), and stable disease (SD).|8 weeks|we analysed the data of 23 patients who were enrolled to this study(intention-to-treat (ITT) population).||percentage of participant with DC||95% Confidence Interval|Number
784590|NCT00824824|Primary|Presence of Retinal Vascular Dysregulation (RVD)|We determined whether RVD was present in the following way. The difference between the retinal blood flow measured while reclining for 30 minutes and the baseline retinal blood flow measured while seated was calculated. In a previous study, we found that among healthy subjects the change in the blood flow while reclining compared to baseline was +6.5% ± 12%. For this study, we defined the normal range of blood flow autoregulation as ± 2 standard deviations about the mean percentage change found in the control group in the initial study (6.5% ± 24.0%); that is, as -17.5% to +30.5%. Participants with a change in retinal blood flow induced by posture change outside this range were randomized to either dorzolamide-timolol fixed combination BID OU or brimonidine-timolol fixed combination BID OU for 6 weeks.|6 weeks post treatment|21 participants were tested for RVD after 6 weeks of timolol treatment. Of the 21 participants who were tested, 7 had RVD and were randomized to Dorzolamide-Timolol and Brimonidine-Timolol; 14 had normal autoregulation. One participant was removed from the analysis in the Brimonidine-Timolol arm due to technical difficulties with equipment.||Participants|||Number
784591|NCT00826176|Secondary|Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.8|Neuromuscular functioning was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade.|Start of administration of sugammadex to recovery from neuromuscular blockade|The Full Analysis Set (FAS) consisted of all subjects who received sugammadex and had at least one efficacy measurement. One treated Chinese subject did not have any efficacy data and was thus excluded from the FAS. Hence, 114 Chinese Asian and 36 European Caucasian subjects were included in the FAS.||minutes||95% Confidence Interval|Geometric Mean
784592|NCT00826176|Secondary|Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.7|Neuromuscular functioning was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade.|Start of administration of sugammadex to recovery from neuromuscular blockade|The Full Analysis Set (FAS) consisted of all subjects who received sugammadex and had at least one efficacy measurement. One treated Chinese subject did not have any efficacy data and was thus excluded from the FAS. Hence, 114 Chinese Asian and 36 European Caucasian subjects were included in the FAS.||minutes||95% Confidence Interval|Geometric Mean
784593|NCT00826176|Primary|Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.9|"Neuromuscular functioning was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.9. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade, with a value of 1.0 representing full recovery.
Analysis of recovery in Chinese subjects was the primary objective; Caucasian subjects and between-group analyses were secondary."|Start of administration of sugammadex to recovery from neuromuscular blockade|The Full Analysis Set (FAS) consisted of all subjects who received sugammadex and had at least one efficacy measurement. One treated Chinese subject did not have any efficacy data and was thus excluded from the FAS. Hence, 114 Chinese Asian and 36 European Caucasian subjects were included in the FAS.||minutes||95% Confidence Interval|Geometric Mean
784594|NCT00826202|Secondary|Pittsburgh Sleep Quality Index Score|The Pittsburgh Sleep Quality Index (PSQI) consists of 19 self-rated questions and five questions rated by the bed partner or roommate. The latter five questions are used for clinical information only, are not tabulated in the scoring of the PSQI. The 19 self-rated questions assess a wide variety of factors relating to sleep quality, including estimates of sleep duration and latency and of the frequency and severity of specific sleep-related problems. These I9 items are grouped into seven component scores, each weighted equally on a 0-3 scale. The seven component scores are then summed to yield a global PSQI score, which has a range of 0-21; higher scores|16 weeks|Completers at NYSPI and NKI sites||final score||Standard Deviation|Mean
784595|NCT00826202|Primary|Scale of Prodromal Symptoms (SOPS) Negative Scale|The SOPS Negative symptom scale consists of six Negative Symptom items. Each item has a severity scale rating from 0 (Never, Absent) to 6 (Severe/Extreme). The severity of the prodromal state is judged according to the sum of the ratings from each of the SOPS items and ranges from 0 to 36.|16 weeks|||SOPS negative final score||Standard Deviation|Mean
784596|NCT00826202|Secondary|IL6 Levels|Final IL6 levels (pg/ml) in available subjects|16 weeks|||final IL6 level (pg/ml))||Standard Deviation|Mean
784597|NCT00826202|Secondary|Scale of Prodromal Symptoms (SOPS) Total|The SOPS Total consists of five Positive Symptom items, six Negative Symptom items, four Disorganization Symptom items, and four General Symptom items. Each item has a severity scale rating from 0 (Never, Absent) to 6 (Severe/Extreme—and Psychotic, for the positive items). The severity of the prodromal state is judged according to the sum of the ratings from each of the SOPS items and ranges from 0 to 114.|16 weeks|||units on a scale||Standard Deviation|Mean
784598|NCT00826228|Secondary|P1NP|amino-terminal propeptide of type I collagen (P1NP)|Baseline to 6 months|Only 8 of the total 12 participants enrolled had serum available for testing||% change from baseline||Standard Deviation|Mean
784599|NCT00826228|Primary|BMD at Left Total Hip|Bone mineral density (gm/cm2) of the total hip region of interest on the left|Baseline to 6 months|||% change in BMD (gm/cm2) from baseline||Standard Deviation|Mean
784600|NCT00826267|Secondary|Changes in Biomarker in Tumour Biopsies|Changes in the biomarkers (Phospho-MAP-Kinase (MAPK), Total MAPK expression, EGFR, HER2, Phospho-EGFR and -HER2, Proliferation marker (Ki67 and p27), Apoptotic index (cleaved caspase 3), Phosphate and tensin homolog (PTEN), HER2 homodimerisation by HERmark assay and Phospho AKT) from biopsy tissue.|Screening, day 22, day 43|TS. The small number of available biomarker samples in this study did not allow for a meaningful statistical analysis.|||||
784601|NCT00826267|Secondary|Plasma Concentration of Afatinib|Individual drug plasma concentrations of afatinib after multiple oral administrations at day 7|Day 7|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
784602|NCT00826267|Secondary|Change From Baseline in the Diameter of the Primary Target Lesion.|Change was based on the primary lesion only rather that the sum of the target lesions as most patients had only one lesion.|3 weeks or 6 weeks|TS||millimeters||Standard Error|Least Squares Mean
784605|NCT00826280|Secondary|Change From Baseline in Diastolic Blood Pressure|"Baseline is the last non-missing measurement on or before first dose of regadenoson.
Change is calculated as the time point minus baseline."|Baseline, Day 5 (-3 min), Day 5 (+3 min), Day 5 (+15 min)|The number of participants analyzed per arm represents Safety Analysis Set (SAF) all randomized patients who received at least one dose of regadenoson. The number of participants included in the calculation for each visit is noted in the category titles, as “N”.||mmHg||Full Range|Median
784606|NCT00826280|Secondary|Change From Baseline in Systolic Blood Pressure|"Baseline is the last non-missing measurement on or before first dose of regadenoson.
Change is calculated as the time point minus baseline."|Baseline, Day 5 (-3 min), Day 5 (+3 min), Day 5 (+15 min)|The number of participants analyzed per arm represents Safety Analysis Set (SAF) all randomized patients who received at least one dose of regadenoson. The number of participants included in the calculation for each visit is noted in the category titles, as “N”.||mmHg||Full Range|Median
784607|NCT00826280|Secondary|Change From Baseline in Heart Rate|"Baseline is the last non-missing measurement on or before first dose of regadenoson
Change is calculated as the time point minus baseline."|Baseline, Day 5 (-3 min), Day 5 (+3 min), Day 5 (+15 min)|The number of participants analyzed per arm represents Safety Analysis Set (SAF) all randomized patients who received at least one dose of regadenoson. The number of participants included in the calculation for each visit is noted in the category titles, as “N”.||Beats per minute||Full Range|Median
784608|NCT00826280|Secondary|Change in Summed Difference Score Across All 17 Segments Assessed by Computerized Quantitation|"The Summed Difference Score was calculated as the difference in the Summed Stress Score across the 17 segments (scan run under stress condition) minus the Summed Rest Score across the 17 segments (scan run under rest conditions).
Change in SDS was calculated as the SDS for regadenoson with caffeine/placebo stress scan (Day 5) minus the SDS for regadenoson only stress scan (Day 3).
The full range of the SDS is -68 to 68, where 0 represents no change between Summed Stress Score and Summed Rest Score. A higher positive score indicates more severe coronary artery disease (CAD)."|Day 3 and Day 5|The number of participants analyzed per arm represents Full Analysis Set (FAS), all randomized subjects with interpretable MPI scans. The number of participants included in the calculation for each visit is noted in the category titles, as “N”.||Summed Difference Score||Standard Deviation|Mean
784609|NCT00826280|Secondary|Change in Number of Reversible Defects Assessed by Computerized Quantitation|"Each segment of the 17-Segment Model was assessed for radiotracer uptake on a scale of 0 (normal uptake) to 4 (absent uptake). Segments were counted as having a reversible defect if the stress score was greater than the rest score and the stress score was ≥ 2.
Change was calculated as the number of reversible defects using regadenoson with caffeine/placebo (Day 5) minus the number of reversible defects using regadenoson alone (Day 3)."|Day 3 and Day 5|The number of participants analyzed per arm represents Full Analysis Set (FAS), all randomized subjects with interpretable MPI scans. The number of participants included in the calculation for each visit is noted in the category titles, as “N”.||Reversible Defects||Standard Deviation|Mean
784610|NCT00826280|Secondary|Change in Summed Difference Score (SDS) Across All 17 Segments|"The Summed Difference Score was calculated as the difference in the Summed Stress Score across the 17 segments (scan run under stress condition) minus the Summed Rest Score across the 17 segments (scan run under rest conditions).
Change in SDS was calculated as the SDS for regadenoson with caffeine/placebo stress scan (Day 5) minus the SDS for regadenoson only stress scan (Day 3).
The full range of the SDS is -68 to 68, where 0 represents no change between Summed Stress Score and Summed Rest Score. A higher positive score indicates more severe coronary artery disease (CAD)."|Day 3 and Day 5|"The number of participants analyzed represents Full Analysis Set (FAS), which included all randomized subjects with interpretable MPI scans.
The number of participants per arm is consistent for all categories of the data table."||Sum Difference Score||Standard Deviation|Mean
784611|NCT00826280|Primary|Change in Number of Reversible Defects|"Each segment of the 17-Segment Model was assessed for radiotracer uptake on a scale of 0 (normal uptake) to 4 (absent uptake). Segments were counted as having a reversible defect if the stress score was greater than the rest score and the stress score was ≥ 2.
Change was calculated as the number of reversible defects using regadenoson with caffeine/placebo (Day 5) minus the number of reversible defects using regadenoson alone (Day 3)."|Day 3 and Day 5|"The number of participants analyzed represents Full Analysis Set (FAS), which included all randomized subjects with interpretable Myocardial Perfusion Imaging (MPI) scans.
The number of participants per arm is consistent for all categories of the data table."||Reversible Defects||Standard Deviation|Mean
784612|NCT00826449|Secondary|Phase II: Progression-Free Survival (PFS) Rate|A modified Thall, Simon, and Estey (1995) design used in the phase II study to monitor the proportion of patients with NSCLC who are alive and progression free (PFS) at twelve weeks after commencing treatment with dasatinib and erlotinib.|12 Weeks|Of the 35 participants in the Phase II portion of the study, one participant received one day of therapy therefore was not evaluable for efficacy analyses; a second participant discontinued study treatment.||Percentage of Participants|||Number
784613|NCT00826449|Secondary|Phase II: Number of Participant With Response According to Response Evaluation Criteria in Solid Tumors (RECIST)|Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria. Patients who have a partial or complete response or stable disease are defined as progression free. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least 30% decrease in sum of longest diameter (LD) of target lesions, reference baseline sum LD; Progressive Disease (PD): At least 20% increase in sum of LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase.|12 Weeks|One participant only received one day of therapy therefore was not evaluable for efficacy analyses; a second participant discontinued study treatment.||participants|||Number
784614|NCT00826449|Primary|Phase I: Maximum Tolerable Dose (MTD) of Dasatinib Given With Erlotinib Hydrochloride|MTD defined as the highest dose level in which 6 patients have been treated with less than 2 instances of dose limiting toxicity (DLT). Dose-limiting toxicity (DLT) defined using NCI Common Terminology Common Terminology Criteria for Adverse Events (CTCAE) version 3 as: grade 3 or higher non-hematologic toxicity (excluding initial nausea and vomiting), grade 4 neutropenia, febrile neutropenia, or grade 4 thrombocytopenia. Grade 3-4 nausea and vomiting that cannot be controlled within 2 weeks with anti-emetics considered a DLT.|Baseline and at Day 21|||mg/day|||Number
784618|NCT00826540|Primary|Progression-free Survival Rate|"The primary endpoint of this trial is progression free survival at 3 months. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be considered evaluable. Patients lost to follow-up before 3 months (e.g., progression, refusing further treatment, etc.) will be considered treatment failures. All eligible patients will be followed until death or a minimum of 3 years. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients.
Progression is defined as at least a 20% increase in the sum of longest liameter of target lesions taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions."|At 3 months|||percentage of participants||95% Confidence Interval|Number
784619|NCT00826618|Secondary|The Incidence of Ocular and Non-ocular Adverse Events Will be Evaluated Through Month 24.||2 years||||||
784620|NCT00826618|Secondary|The Mean Change in Foveal Retinal Thickness From Baseline at 7 Days, and at 30, 60, 90, 120 Days, and 12 Months Will be Computed Using a T-test.||1 year||||||
784621|NCT00826618|Secondary|The Percentage of Patients With 15 Letters (3 Lines) of Visual Acuity Improvement at 30, 60, 90, 120 Days, and 12 Months.||1 year||||||
784622|NCT00826618|Secondary|The Mean Change in Best Corrected Visual Acuity (BCVA) (Assessed by the ETDRS Chart at 4 Meters) From Baseline at 12 Months Will be Computed With a T-test.||1 year||||||
784623|NCT00826618|Primary|Change From Baseline in Early Treatment Diabetic Retinopathy Study (ETDRS at 4 Meters) at 12 Months.|Mean change in best corrected visual acuity (assessed by the ETDRS chart at 4 m) from baseline at 12 months following first intravitreal injection of ranibizumab was 12.2 ETDRS letters (P = 0.015).|1 year|||Change in ETDRS Letters||Standard Deviation|Mean
784624|NCT00826800|Primary|To Determine the Pathologic Complete Response (Path CR) Rate in Patients With Locally Advanced (Stage II or III) Colon Cancer to FOLFOX-bevacizumab Administered as Neoadjuvant.||3 years|||participants|||Number
784625|NCT00826943|Primary|Likert Score Rating Global Sedation|"Likert score range 1 to 9 (no sedation to extreme sedation). Highers scores indicate increased sedation. This was measured on days days 5, 12, 17, 24, 29, and 36 of the study.
This was mean data for all interventions."|duration of study (36 days)|per protocol||Likert score||Standard Deviation|Mean
784626|NCT00826943|Primary|Modified Epworth Sleepiness Scale|"Epworth Sleepiness Scale ratings (0 to 24); higher scores = increased sedation. This was measured over the 36 days of the study (at the end of each washout period and each intervention period); measured on days 5, 12, 17, 24, 29, and 36.
This was mean data for all interventions."|36 days of the study|per protocol||units on a scale||Standard Deviation|Mean
784627|NCT00826943|Secondary|Total Four Symptom Scores (Allergy Symptoms)|"Total Four Symptom Scores (TFSS) ranging 0 to 12. Increased scores indicate increased symptoms. This was measured on days 5, 12, 17, 24, 29, and 36 of the study. The mean TFSS for patients receiving placebo, cetirizine, and levocetirizine was then calculated.
This was mean data for all interventions."|same as primary outcome measure (obtain on days 5, 12, 17, 24, 29, and 36)|||TFSS scores||Standard Deviation|Mean
784628|NCT00827073|Primary|Number of Bacterial Species in Pre-antibiotic Administration and in Post Study Medication Swabs||(1) Pre-antibiotics swab and (2) Post-study medication (pre surgery)|||bacterial spceies||Standard Deviation|Mean
784629|NCT00827073|Primary|Change in Ln(Bacterial Colony Count) From Pre-antibiotic Administration to Post Study Medication Swabs|Within 3 hours from time of culture acquisition, the samples will be vortexed for 30 seconds and 100µl aliquots will be plated onto 5% sheep blood and chocolate agar plates. These plates will be incubated with 5% carbon dioxide at 35˚ C for 72 hours. After 72 hours all plates will be read for colony count and identification of all isolates will be performed using routine microbiological methods. The natural log of bacterial bacterial colony count will be used for the outcome measure.|(1) Pre-antibiotics swab, and (2) Post-study medication (pre surgery)|||Ln(bacterial colony count)||Standard Deviation|Mean
784630|NCT00827099|Secondary|Number of Patients Who Survive Following Treatment on This Protocol|Patients will be followed until death|Through Death|This study was terminated early. No participants were analyzed.||participants|||Number
784631|NCT00827099|Secondary|Number of Patients Who Experience Disease Relapse Post-transplant|Patients will have routine restaging to assess disease response at Day 100, 6 months, 1 year, 18 months and 24 months. If disease relapse is suspected, the patient will be evaluated at that time.|Day 100, 6 months, 1 year, 18 months, 24 months|This study was terminated early. No participants were analyzed.||participants|||Number
784632|NCT00827099|Secondary|Number of Patients Who Experience Acute and Chronic Graft-vs-host Disease After Transplant.|Patients will be evaluated regularly for the development of graft versus host disease both acute & chronic.|Day 30|This study was terminated early. No participants were analyzed.||participants|||Number
784633|NCT00827099|Secondary|Percentage of Donor and Host Chimerism of Each Cord Blood Unit|Evaluate the percentages of donor and host chimerism at multiple times post-transplant including Day 30, Day 60, Day 90 and monthly thereafter if the patient is not considered to have full chimerism.|day 30, day 60, day 90|This study was terminated early. No participants were analyzed.||percentage of chimerism|||Number
784634|NCT00827099|Secondary|Number of Patients That Engrafted Blood Counts by 30 Days After Transplant|Number of patients whose Absolute Neutrophil Count (ANC) recovered to >500 x10^3/uL for at least 3 consecutive days after transplant|Day 30|||participants|||Number
784635|NCT00827099|Primary|Number of Participants With 100 Day Transplant-related Mortality (TRM)|100 Day TRM is death within 100 days from transplant related complications|100 days|||participants|||Number
784636|NCT00827112|Secondary|Number of Participants With HIV-1 RNA Tropism Status Using Trofile Assay|Viral tropism was determined using the trofile assay with enhanced sensitivity for participants with HIV-1 RNA greater than equal to 1000 copies/mL. The enhanced trofile assay had the sensitivity to detect 100 percent of spiked samples when C-X-C chemokine receptor type 4 {CXCR4} [X4]-using HIV-1 RNA represented 0.3 percent of the total viral population.|Baseline to Week 96 or Time of treatment Failure|FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement.||Participants|||Number
784686|NCT00827606|Secondary|Percentage of Participants With Overall Expected Maturation and Development Consistent With Expectations as Assessed by the Investigator||Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36 (or early termination)|FAS; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
784637|NCT00827112|Secondary|Number of Participants With Phenotypic Resistance|Phenotypic resistance was assessed for all participants at screening and was evaluated for PIs, NRTIs, and NNRTIs using Monogram GenoSeq and/or PhenoSenseGT assays. This was then repeated for all participants with HIV-1 viral load more than 500 copies/mL either at treatment failure or at early termination, up to Week 96.|Week 96 or Time of treatment failure|FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement.||Participants|||Number
784638|NCT00827112|Secondary|Number of Participants With Genotypic Resistance|Genotypic resistance was assessed for all participants at screening and was evaluated for protease inhibitors (PIs), Nucleotide reverse transcriptase inhibitors (NRTIs), and non-NRTIs (NNRTIs) using Monogram GenoSeq and/or PhenoSenseGT assays. This was then repeated for all participants with HIV-1 viral load more than 500 copies/mL either at treatment failure or at early termination, up to Week 96.|Week 96 or Time of treatment failure|FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement.||Participants|||Number
784639|NCT00827112|Secondary|Change From Baseline in Cluster of Differentiation 8+T Lymphocyte (CD8) Cell Count at Weeks 16, 24, 48 and 96||Baseline, Week 16, Week 24, Week 48, Week 96|FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement. Here “n” signified participants who received the study drug and evaluated at the time point.||cells/mcL||Standard Deviation|Mean
784640|NCT00827112|Secondary|Change From Baseline in Cluster of Differentiation 4+T Lymphocyte (CD4) Cell Counts at Weeks 16, 24, 48 and 96||Baseline, Week 16, Week 24, Week 48, Week 96|FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement. Here “n” signified participants who received the study drug and evaluated at the time point.||cells/microliter (cells/mcL)||Standard Deviation|Mean
784641|NCT00827112|Secondary|Time-Averaged Difference (TAD) in log10 Viral Load|TAD was calculated as area under the curve of HIV divided by time period minus baseline HIV where HIV was denoted as HIV-1 RNA (log10 copies/mL).|Week 16, Week 24, Week 48, Week 96|FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement. Here N (Number of participants analyzed) signified participants evaluable for the measure.||log10 copies/mL||Standard Error|Mean
784642|NCT00827112|Secondary|Time to Loss of Virological Response (TLOVR)|TLOVR (virological failure) was defined as the time from first dose of study treatment (Day 1) until the time of virologic failure using the time to loss of virologic response algorithm.|Baseline through Week 96|FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement.||Days||Standard Error|Mean
784643|NCT00827112|Secondary|Percentage of Participants With Less Than 400 Copies/mL of HIV-1 RNA||Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, Week 96|FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement. Here “n” signified participants who received the study drug and evaluated at the time point.||Percentage of participants||95% Confidence Interval|Number
784644|NCT00827112|Secondary|Percentage of Participants With Less Than 50 Copies/mL of HIV-1 RNA||Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, Week 96|FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement. Here “n” signified participants who received the study drug and evaluated at the time point.||Percentage of participants||95% Confidence Interval|Number
784645|NCT00827112|Secondary|Change From Baseline in Plasma log10 Viral Load at Weeks 16, 24, 48 and 96||Baseline, Week 16, Week 24, Week 48, Week 96|FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement. Here “n” signified participants who received the study drug and evaluated at the time point.||log10 copies/ml||Standard Deviation|Mean
784646|NCT00827112|Secondary|Average Observed Plasma Concentration (Cavg) of Maraviroc|Cavg was described as area under the plasma concentration-time profile from time zero to time 24 hours (AUC24) divided by the dosing interval (AUC24/ 24).|Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose)|PK parameter analysis population included first 15 participants treated with maraviroc.||ng/mL||Standard Deviation|Mean
784647|NCT00827112|Secondary|Minimum Observed Plasma Concentration (Cmin) of Maraviroc||Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose)|PK parameter analysis population included first 15 participants treated with maraviroc.||ng/mL||Full Range|Median
784648|NCT00827112|Secondary|Maximum Observed Plasma Concentration (Cmax) of Maraviroc||Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose)|Pharmacokinetic (PK) parameter analysis population included first 15 participants treated with maraviroc.||nanogram (ng)/mL||Full Range|Median
784649|NCT00827112|Secondary|Change From Baseline in HIV-1 RNA Levels of First 15 Participants at Days 4, 7, 10 and 14|Plasma HIV-1 RNA levels were evaluated for first 15 participants enrolled at United States (U.S) sites only.|Baseline , Days 4, 7, 10 and 14|First 15 participants who were enrolled at U.S sites and had taken the study drug .||copies/mL||Standard Deviation|Mean
784650|NCT00827112|Secondary|HIV-1 RNA Levels at Baseline||Baseline|FAS population included those participants who had taken at least one dose of the study drug, had baseline and at least one post baseline measurement.||copies/mL||Standard Deviation|Mean
784651|NCT00827112|Primary|Percentage of Participants With Plasma Human Immuno Deficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) Levels Less Than 50 Copies/Milliliter (mL)||Week 48|Full Analysis Set (FAS) population included those participants who had taken at least one dose of the study drug, had baseline and at least one post baseline measurement.||Percentage of participants||95% Confidence Interval|Number
784652|NCT00827242|Secondary|Change From Baseline to 12 Weeks, Postvoid Residual (PVR) Volume|The amount of urine remaining in the bladder after void completion.|Baseline, 12 weeks|The analysis population was defined as all randomized subjects who started study medication, and had non-missing data at baseline and at endpoint (considered the last non-missing post-baseline value).||mL||Standard Deviation|Mean
784687|NCT00827606|Primary|Percent Change From Baseline in Age: Females|Investigator assessment of age during the study.|Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; only female participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.||percent change||Standard Deviation|Mean
784653|NCT00827242|Secondary|Change From Baseline to 12 Weeks, Voided Volume (Vcomp) by Uroflowmetry|Vcomp was defined as the volume of urine voided (measured in mL using standard calibrated flowmeter). At each visit, a uroflowmetry assessment was considered valid and the data were included in the statistical analyses only if the prevoid total bladder volume (assessed by ultrasound) was >=150 to <=550 mL and the Vcomp was >=125 mL.|Baseline, 12 weeks|The analysis population was defined as all randomized subjects who started study medication, and had non-missing data at baseline and at endpoint (considered the last non-missing post-baseline value).||mL||Standard Deviation|Mean
784654|NCT00827242|Secondary|Change From Baseline to 12 Weeks, Mean Flow Rate (Qmean) by Uroflowmetry|Qmean was defined as the mean urine flow rate (measured in mL/sec using standard calibrated flowmeter). At each visit, a uroflowmetry assessment was considered valid and the data were included in the statistical analyses only if the prevoid total bladder volume (assessed by ultrasound) was >=150 to <=550 mL and the Vcomp was >=125 mL.|Baseline, 12 weeks|The analysis population was defined as all randomized subjects who started study medication, and had non-missing data at baseline and at endpoint (considered the last non-missing post-baseline value).||mL/sec||Standard Deviation|Mean
784655|NCT00827242|Secondary|Change From Baseline to 12 Weeks, Peak Flow Rate (Qmax) by Uroflowmetry|Qmax was defined as the peak urine flow rate (measured in milliliters per second [mL/sec] using standard calibrated flowmeter). At each visit, a uroflowmetry assessment was considered valid and the data were included in the statistical analyses only if the prevoid total bladder volume (assessed by ultrasound) was >=150 to <=550 milliliters (mL) and the voided volume (Vcomp) was >=125 mL.|Baseline, 12 weeks|The analysis population was defined as all randomized subjects who started study medication, and had non-missing data at baseline and at endpoint (considered the last non-missing post-baseline value).||mL/sec||Standard Deviation|Mean
784656|NCT00827242|Secondary|Change From Baseline to 12 Weeks, International Index of Erectile Function (IIEF)- Erectile Function (EF) Domain Scores|Self-reported EF. Scores range from 0 (low or no EF) to 5 (high EF) on 6 questions (1-5, 15 of the IIEF). EF Domain scores range from 0 to 30. LS mean of change from baseline to endpoint is from an ANCOVA. The model includes terms for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|The analysis population was defined as all randomized subjects who started study medication, and had non-missing data at baseline and at least one post-baseline measurement. Measures were taken only for those subjects who reported they were sexually active and reported erectile dysfunction. The LOCF imputation technique was employed.||Units on a Scale||Standard Error|Least Squares Mean
784657|NCT00827242|Secondary|Change From Baseline to 4 Weeks, International Prostate Symptom Score (IPSS)|The IPSS Total Score is obtained by combining the scores of the responses to Question 1 through Question 7. Each question is scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. LS mean of change from baseline to endpoint is from an ANCOVA. The model includes terms for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 4 Weeks|The analysis population includes all subjects who were randomized, started study medication, and had non-missing data at baseline and Week 4.||Units on a Scale||Standard Error|Least Squares Mean
784658|NCT00827242|Secondary|Change From Baseline to 1 Week, International Prostate Symptom Score (IPSS)|The IPSS Total Score is obtained by combining the scores of the responses to Question 1 through Question 7. Each question is scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. LS mean of change from baseline to endpoint is from an ANCOVA. The model includes terms for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 1 week|The analysis population includes all subjects who were randomized, started study medication, and had non-missing data at baseline and Week 1.||Units on a Scale||Standard Error|Least Squares Mean
784659|NCT00827242|Secondary|Clinical Global Impression of Improvement (CGI-I), Number of Participants in 7 Response Categories|Measures clinician's perception of patient improvement at the time of assessment compared with the start of treatment. Scores range from 1 (very much better) to 7 (very much worse).|12 weeks|All values are based on the number of subjects in the analysis population with non-missing data.||Participants|||Number
784660|NCT00827242|Secondary|Patient Global Impression of Improvement (PGI-I), Number of Participants in 7 Response Categories|A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).|12 weeks|The analysis population includes all subjects who were randomized, started study medication, and had non-missing data.||Participants|||Number
784661|NCT00827242|Secondary|Change From Baseline to 12 Weeks, International Prostate Symptom Score (IPSS) Quality of Life (QoL) Index|Assessment of QoL by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible). LS mean of change from baseline to endpoint is from an ANCOVA. The model includes terms for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|The analysis population was defined as all randomized subjects who started study medication, and had non-missing data at baseline and at least one post-baseline measurement. The LOCF imputation technique was employed.||Units on a Scale||Standard Error|Least Squares Mean
784662|NCT00827242|Secondary|Change From Baseline to 12 Weeks, International Prostate Symptom Score (IPSS) Nocturia Question|Measures nocturia (the need to get up at night to urinate). Scores range from 0 (few episodes of nocturia) to 5 (frequent episodes of nocturia). LS mean of change from baseline to endpoint is from an ANCOVA. The model includes terms for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|The analysis population was defined as all randomized subjects who started study medication, and had non-missing data at baseline and at least one post-baseline measurement. The LOCF imputation technique was employed.||Units on a Scale||Standard Error|Least Squares Mean
784672|NCT00827372|Secondary|Change in Impedance or ECF Volume in the Arm|"Arm impedance was reported at two baseline readings and for Cycle 2, Day 1.
To assess the degree of improvement in arm edema as measured by changes in arm impedance (ECF volume using an automated device lymphometer). Data reported is the ratio of the impedance in the affected versus unaffected arm"|Baseline, and Cycle 2, Day 1|All patients with non-missing results. This includes 8 patients at the first baseline, 10 patients at the second baseline, and 7 patients at Cycle 2, Day 1.||ratio||Standard Deviation|Median
784663|NCT00827242|Secondary|Change From Baseline to 12 Weeks, International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore|IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 0 (few obstructive symptoms) to 5 (frequent obstructive symptoms), thus the 4 questions of the obstructive score range from 0 to 20. LS mean of change from baseline to endpoint is from an ANCOVA. The model includes terms for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|The analysis population was defined as all randomized subjects who started study medication, and had non-missing data at baseline and at least one post-baseline measurement. The LOCF imputation technique was employed.||Units on a Scale||Standard Error|Least Squares Mean
784664|NCT00827242|Secondary|Change From Baseline to 12 Weeks, International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore|IPSS irritative subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. Scores range from 0 (few irritative symptoms) to 5 (frequent irritative symptoms), thus the 3 questions of the irritative subscore range from 0 to 15. LS mean of change from baseline to endpoint is from an ANCOVA. The model includes terms for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|The analysis population was defined as all randomized subjects who started study medication, and had non-missing data at baseline and at least one post-baseline measurement. The LOCF imputation technique was employed.||Units on a Scale||Standard Error|Least Squares Mean
784665|NCT00827242|Secondary|Change From Baseline to 12 Weeks, Benign Prostatic Hyperplasia (BPH) Impact Index|The BII is a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores range from 0 to 13; higher scores represent increased perceived impact of benign prostatic hyperplasia-lower urinary tract symptoms on overall health. LS mean of change from baseline to endpoint is from an ANCOVA. The model includes terms for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|The analysis population includes all subjects who were randomized, started study medication, and had non-missing data at baseline and Week 12. For the 12 week analysis, the LOCF imputation technique was used.||Units on a Scale||Standard Error|Least Squares Mean
784666|NCT00827242|Secondary|Change From Baseline to 4 Weeks, Benign Prostatic Hyperplasia (BPH) Impact Index|The BPH Impact Index (BII) is a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores range from 0 to 13; higher scores represent increased perceived impact of benign prostatic hyperplasia-lower urinary tract symptoms on overall health. LS mean of change from baseline to endpoint is from an ANCOVA. The model includes terms for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 4 weeks|The analysis population includes all subjects who were randomized, started study medication, and had non-missing data at baseline and Week 4.||Units on a Scale||Standard Error|Least Squares Mean
784667|NCT00827242|Primary|Change From Baseline to 12 Weeks, International Prostate Symptom Score (IPSS)|The IPSS Total Score is obtained by combining the scores of the responses to Question 1 through Question 7. Each question is scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|The analysis population was defined as all subjects who were randomized, started study medication, and had non-missing data at baseline and at least one post-baseline visit. The Last Observation Carried Forward (LOCF) imputation technique was employed.||Units on a Scale||Standard Error|Least Squares Mean
784668|NCT00827255|Secondary|Schirmer's Test at Month 12|Schirmer's test at month 12. The Schirmer's tear test is performed on the eye with or without anesthesia (numbing eye drop). The amount of tears produced by the eye in 5 minutes is measured in millimeters by means of a graduated paper scale. Data not reported due to limited number of patients with Schirmer's test data recorded.|Month 12|ITT population, which consisted of all patients included in the study with Schirmer's testing data available at baseline. Data not reported due to limited number of patients with Schirmer's test data recorded.||Millimeters per five minutes (mm/5min)||Standard Deviation|Mean
784669|NCT00827255|Primary|Percentage of Patients With Complete Clearing of Corneal Staining at Month 12|Percentage of patients with complete clearing of corneal staining at month 12. Corneal staining is evaluated following administration of fluorescein dye into the eye. Complete clearing is defined as the absence of corneal staining.|Month 12|ITT population, which consisted of all patients included in the study, with documented presence of corneal staining at baseline. For this outcome measure, a total of 18 patients had documented corneal staining at baseline.||Percentage of Patients|||Number
784670|NCT00827372|Secondary|Clinical Benefit as Assessed by Quality of Life Questionnaire (FACT-B+4 Lymphedema Questions)|"The quality of life questionnaire (FACT-B+4 lymphedema questions) was given at various timepoints during the study. The values for the subscales are given for baseline, Cycle 1:Day 1, Cycle 2:Day 1, and Cycle 6:Day 1.
Physical Well-Being (PWB; sum of 7 items, point range 0-28) Social /Family Well-Being (SWB, sum of 7-items, point range 0-28) Emotional Well-Being (EWB; sum of 6-items, point range 0-24) Functional Well-Being (FWB; sum of 7-items, point range 0-28) Additional Concerns (BCS; sum of 9-items, point range 0-36) Arm subscale (AS; sum of 5-items, point range 0-20) -- This was not collected in Cycle 1 or 2.
Fact-B+4 score=Sum of PWB, SWB, EWB, FWB, BCS, AS, point range 0-164 Trial Outcome Index=Sum of PWB, FWB, BCS, point range 0-92 Fact-G score=sum of PWB, SWB, EWB, FWB, point range 0-108 Fact-B score=sum of PWB, SWB, EWB, FWB, BCS, point range 0-144 Note: The higher the score, the better the outcome"|Baseline through Cycle 6, Day 1|All patients with non-missing results. There were 10 patients at baseline/Cycle 1, Day 1, 7 patients at Cycle 2, Day 1, and 2 patients who completed the 6 cycles of treatment.||Units on a scale||Standard Deviation|Mean
784671|NCT00827372|Secondary|Number of Patients With Trt Related Grade 2+ AEs|This is the number of patients who had greater than or equal to Grade 2 Adverse Events related to treatment. This also includes the number of patients who had treatment related Grade 2 or greater Adverse Events that lasted more than 2 weeks (14 days) and excluded events of hypertension (labeled as 'special').|End of Treatment|All treated patients||participants|||Number
784849|NCT00821951|Secondary|Target Lesion Response||1 Year||||||
784673|NCT00827372|Secondary|Changes in Interstitial Fluid Pressure (ECF Volume) in the Arm|"Interstitial fluid pressure was reported at 24 hours. This is the difference in the last-first reading, affected arm.
To assess the degree of improvement in arm edema as measured by changes in interstitial fluid pressure (ECF volume using an automated device lymphometer)"|First 24 hours after drug was administered|All patients with non-missing results at both baseline and at 24 hours.||mm Hg||Standard Deviation|Mean
784674|NCT00827372|Primary|Change in Volume Ipsilateral Lymphedema in Arm|The primary endpoint will be change in excess arm volume (affected arm volume minus unaffected arm volume) compared to baseline. This will be done at Cycle 2 (29 days) and Cycle 6 (174 days).|Baseline through Cycle 6, Day 1|All patients with non-missing results. There were 10 patients at baseline, 7 patients at Cycle 2, Day 1, and 2 patients who completed the 6 cycles of treatment.||mL||Standard Deviation|Mean
784675|NCT00827502|Primary|Number of Subjects With an Investigator Assessment of Clinical Outcome (Cure/Improvement/Failure) at End of Study|Cure: Disappearance of all pre-treatment signs and symptoms of infection; Improvement: Improvement in, or partial disappearance of signs and symptoms without requiring further antibacterial therapy. Subjects who discontinued study drug for reasons other than lack of clinical response, i.e., despite clinical improvement, were included in this category; and Failure: No change in, or worsening of baseline signs and symptoms requiring modification of treatment, ie, addition of or switch to another systemic antibacterial therapy. An unknown response or missing value was considered clinical failure.|Baseline to 2 weeks|The efficacy evaluable (EVAL) population included subjects in the FAS having at least 1 definitive follow up global response assessment to treatment of URTIs.||Participants|||Number
784676|NCT00827502|Secondary|Cost (in Indian Rupees) Per Participant of Utilizations Including General Consultations, Medications, Chest X-ray, Complete Blood Count, and Erythrocyte Sedimentation Rate|Cost (in Indian Rupees) per participant of utilizations including general consultations over the study; each medication over the study (study drug, analgesics, antipyretics, anti-inflammatory drugs, vitamins, other study medication), radiological tests over the study (chest X-ray); and clinical laboratory tests over the study (complete blood count and erythrocyte sedimentation rate).|Baseline to 3 months|FAS||cost (in Indian Rupees) per participant||Full Range|Median
784677|NCT00827502|Primary|Number of Subjects With an Investigator Assessment of Clinical Outcome (Success/Failure) at End of Study|Success: Cure (disappearance of all pre-treatment signs and symptoms of infection) or improvement in or partial disappearance of signs and symptoms not requiring further treatment at end of study; Failure: No change in, or worsening of baseline signs and symptoms requiring modification of treatment, ie, addition of or switch to another systemic antibacterial therapy. Unknown or missing values were considered as failure.|Baseline to 2 weeks|The full analysis set (FAS) included all subjects who received at least one dose of study medication.||participants|||Number
784678|NCT00827541|Secondary|Number of Participants With Eradication of Microbiological Pathogens|Evaluation of eradication after treatment with tigecycline included following microbiological pathogens: E. coli ESBL; K. pneumoniae ESBL; Bacteroides species RClin; S. aureus (MRSA); Enterococcus species (VRE); Enterobacter species RCef3; Serratia species RCef3; Proteus species ESBL; P. aeruginosa RCarb; A. baumannii RCarb.|Week 12|Data was not analyzed since the number of samples obtained for culture was very low.||participants|||Number
784679|NCT00827541|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Any untoward medical occurrence in a participant who received study treatment was considered an AE without regard to possibility of causal relationship. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a SAE: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Up to Week 12|Safety population included all evaluable participants who received at least one dose of study medication and had at least one evaluation visit.||participants|||Number
784680|NCT00827541|Secondary|Number of Participants With Susceptible Microbiological Pathogens|Evaluation of susceptibility to the tigecycline treatment included: Escherichia coli Extended Spectrum Beta Lactamases (E. coli ESBL); Klebsiella pneumoniae (K. pneumoniae) ESBL; Bacteroides species resistant to clindamycin (RClin); Staphylococcus aureus (S. aureus) methicillin resistant S. aureus (MRSA); vancomycin resistant Enterococcus (VRE) species; Resistant to third generation cephalosporins (RCef3) Enterobacter species; RCef3 Serratia species; Proteus species ESBL; carbapenem resistant (RCarb) Pseudomonas aeruginosa (P. aeruginosa); Acinetobacter baumannii (A. baumannii) RCarb.|Baseline and Week 12|Data was not summarized since the number of susceptibility tests to tigecycline during the study was extremely low.||participants|||Number
784681|NCT00827541|Secondary|Percentage of Participants With Clinical Response of Cure|Cure was defined as complete resolution of infection symptoms and clinical signs of the disease to the extent that no further antibiotic treatment was required, as assessed by the attending physician.|Days 2-5, 7-14 and 21-28 during treatment and Days 1-3 after end of treatment|Intent-To-Treat (ITT) population included all evaluable participants who had at least one dose of study medication and one evaluation visit. 'n' signifies those participants who were evaluated for this measure at specified time points for each group respectively.||percentage of participants|||Number
784682|NCT00827567|Primary|Time to Progression(TTP)|Progression is defined by RESIST criteria as any new lesion or the sum of target lesions increasing by 20% over baseline|Each patient assessed at 8 weeks from start of study drug||||||
784683|NCT00827606|Secondary|Percentage of Participants by Study Drug Compliance Category|Compliance to study drug was categorized as <80%, 80% - 120%, and greater than (>) 120%.|Months 1, 2, 3, 6, 12, 18, 24, 30, and 36 (or early termination)|Safety Analysis Set: all participants who received at least 1 dose of study drug; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
784684|NCT00827606|Primary|Percent Change From Baseline in FMD|Percent (%) FMD was calculated as (hyperemic diameter minus resting diameter) divided by the resting diameter multiplied by 100.|Months 6, 12, 18, 24, 30 and 36/ET|FMD Set; n=number of participants assessed for the specified parameter at a given visit.||percent change||Standard Deviation|Mean
784685|NCT00827606|Primary|Flow-Mediated Dilatation (FMD) During the Study|Percent (%) FMD was calculated as (hyperemic diameter minus resting diameter) divided by the resting diameter multiplied by 100. Change from baseline was also determined.|Baseline, Months 6, 12, 18, 24, 30 and 36/ET|FMD Set: all participants enrolled in the FMD study who had at least baseline FMD measurements. n=number of participants assessed for the specified parameter at a given visit.||% FMD||Standard Deviation|Mean
784688|NCT00827606|Primary|Age (Years) During the Study: Females|Investigator assessment of age during the study. Change from baseline was also determined.|Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; only female participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.||years||Standard Deviation|Mean
784689|NCT00827606|Primary|Percent Change From Baseline in Age: Males|Investigator assessment of age during the study.|Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; only male participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.||percent change||Standard Deviation|Mean
784690|NCT00827606|Primary|Age (Years) During the Study: Males|Investigator assessment of age during the study. Change from baseline was also determined.|Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; only male participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.||years||Standard Deviation|Mean
784691|NCT00827606|Primary|Percent Change From Baseline in BMI: Females|Investigator assessment of BMI changes during the study.|Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; only female participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.||percent change||Standard Deviation|Mean
784692|NCT00827606|Primary|BMI (kg/m^2) During the Study: Females|Investigator assessment of BMI changes during the study. Change from baseline was also determined.|Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; only female participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.||kg/m^2||Standard Deviation|Mean
784693|NCT00827606|Primary|Percent Change From Baseline in BMI: Males|Investigator assessment of BMI changes during the study.|Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; only male participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.||percent change||Standard Deviation|Mean
784694|NCT00827606|Primary|Body Mass Index (BMI in kg Per Square Meter [kg/m^2]) During the Study: Males|Investigator assessment of BMI changes during the study. Change from baseline was also determined.|Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; only male participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.||kg/m^2||Standard Deviation|Mean
784695|NCT00827606|Primary|Percent Change From Baseline in Weight: Females|Investigator assessment of weight changes during the study.|Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; only female participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.||percent change||Standard Deviation|Mean
784696|NCT00827606|Primary|Weight (kg) During the Study: Females|Investigator assessment of weight changes during the study. Change from baseline was also determined.|Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; only female participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.||kg||Standard Deviation|Mean
784697|NCT00827606|Primary|Percent Change From Baseline in Weight: Males|Investigator assessment of weight changes during the study.|Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; only male participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.||percent change||Standard Deviation|Mean
784698|NCT00827606|Primary|Weight (Kilograms [kg]) During the Study: Males|Investigator assessment of weight changes during the study. Change from baseline was also determined.|Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; only male participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.||kg||Standard Deviation|Mean
784699|NCT00827606|Primary|Percent Change From Baseline in Height: Females|Investigator assessment of height changes during the study.|Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; only female participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.||percent change||Standard Deviation|Mean
784700|NCT00827606|Primary|Height (cm) During the Study: Females|Investigator assessment of height changes during the study. Change from baseline was also determined.|Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; only female participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.||cm||Standard Deviation|Mean
784701|NCT00827606|Primary|Percent Change From Baseline in Height: Males|Investigator assessment of height changes during the study.|Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; only male participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.||percent change||Standard Deviation|Mean
784702|NCT00827606|Primary|Height (Centimeters [cm]) During the Study: Males|Investigator assessment of height changes during the study. Change from baseline was also determined.|Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; only male participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.||cm||Standard Deviation|Mean
784703|NCT00827606|Primary|Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage|Tanner_Stage was assessed based on 2 components by gender, pubic hair and breasts for females and pubic hair and genitalia for males. If these values of components were not same, then the Tanner_Stage had the higher value of 2 components for each gender by visit.|Baseline, Months 6, 12, 18, 24, 30, and 36/ET|FAS; n=number of participants assessed for the specific parameter at a given visit.||participants|||Number
784704|NCT00827606|Primary|Percent Change From Baseline in Apo B|Assessments were performed in the fasting state (minimum 10-hour fast).|Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; n=number of participants assessed for the specified parameter at a given visit.||percent change||Standard Deviation|Mean
784705|NCT00827606|Primary|Apoliprotein B (Apo B; g/L) During the Study|Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.|Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; n=number of participants assessed for the specified parameter at a given visit.||g/L||Standard Deviation|Mean
784706|NCT00827606|Primary|Percent Change From Baseline in Apo A-1|Assessments were performed in the fasting state (minimum 10-hour fast).|Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; n=number of participants assessed for the specified parameter at a given visit.||percent change||Standard Deviation|Mean
784850|NCT00821951|Primary|The Primary Endpoint of the Study is to Establish the Maximum Tolerated Dose of Vorinostat When Given Concurrently With Palliative Radiation.|maximum tolerated dose of vorinostat when given concurrently with radiation|1 Year|All participants who received any drug||mg|||Number
784707|NCT00827606|Primary|Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study|Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.|Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; n=number of participants assessed for the specified parameter at a given visit.||g/L||Standard Deviation|Mean
784708|NCT00827606|Primary|Percent Change From Baseline in VLDL|Assessments were performed in the fasting state (minimum 10-hour fast).|Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; n=number of participants assessed for the specified parameter at a given visit.||percent change||Standard Deviation|Mean
784709|NCT00827606|Primary|Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study|Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.|Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; n=number of participants assessed for the specified parameter at a given visit.||mMol/L||Standard Deviation|Mean
784710|NCT00827606|Primary|Percent Change From Baseline in Trigylcerides|Assessments were performed in the fasting state (minimum 10-hour fast).|Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; n=number of participants assessed for the specified parameter at a given visit.||percent change||Standard Deviation|Mean
784711|NCT00827606|Primary|Trigylcerides (mMol/L) During the Study|Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.|Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; n=number of participants assessed for the specified parameter at a given visit.||mMol/L||Standard Deviation|Mean
784712|NCT00827606|Primary|Percent Change From Baseline in Total Cholesterol|Assessments were performed in the fasting state (minimum 10-hour fast).|Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; n=number of participants assessed for the specified parameter at a given visit.||percent change||Standard Deviation|Mean
784713|NCT00827606|Primary|Total Cholesterol (mMol/L) During the Study|Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.|Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; n=number of participants assessed for the specified parameter at a given visit.||mMol/L||Standard Deviation|Mean
784714|NCT00827606|Primary|Percent Change From Baseline in HDL-C|Assessments were performed in the fasting state (minimum 10-hour fast).|Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; n=number of participants assessed for the specified parameter at a given visit.||percent change||Standard Deviation|Mean
784715|NCT00827606|Primary|High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study|Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.|Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; n=number of participants assessed for the specified parameter at a given visit.||mMol/L||Standard Deviation|Mean
784716|NCT00827606|Primary|Percent Change From Baseline in LDL-C|Assessments were performed in the fasting state (minimum 10-hour fast).|Months 1, 2, 3, 6, 12, 18, 24, 30 and 36 (or ET)|FAS; n=number of participants assessed for the specified parameter at a given visit.||percent change||Standard Deviation|Mean
784717|NCT00827606|Primary|Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study|Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.|Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36 (or early termination [ET])|FAS; n (number) equals (=) number of participants assessed for the specified parameter at a given visit.||mMol/L||Standard Deviation|Mean
784718|NCT00827632|Secondary|Pharmacokinetics of 15 Obese Weight and 15 Normal Weight Women on Combined Oral Contraceptives.||24 hours during week 3 of follow-up cycle||||||
784719|NCT00827632|Secondary|Possible Changes in Lipid or Carbohydrate Metabolism in Obese Versus Normal Weight Oral Contraceptive (OC) Users.||Screening and follow-up 1||||||
784720|NCT00827632|Primary|Risk of Oral Contraceptive (OC) Failure Due to Less Contraceptive-mediated Ovarian Suppression.|"Perpendicular diameter, ethinyl estradiol, and progesterone values were used to create Hoogland Scores. Hoogland Scores were used to assess ovarian suppression during OC use. The Hoogland Score comprises 6 grades (Because of small numbers, grades 5 and 6 were combined):
no activity
potential activity
nonactive follicle-like structure
active follicle-like structure
luteinized unruptured follicle
ovulation
Each participant received a score from 1-6 to indicate the level of ovarian suppression; total number of participants were tallied for each Hoogland score."|Up to 8 biweekly visits from start of OCP therapy|Two hundred twenty-six women enrolled, 150 consistent OCP users were retained for the main analysis (96 normal weight and 54 obese).||Participants|||Number
784721|NCT00827827|Primary|Change in Non-Paretic Limb Step Length (Fastest)|This and other measures come from Instrumented Walkway (Gait Rite)|Baseline, 3 Months|All participants for whom measurement was recorded at Baseline and 3 months||cm||Standard Error|Mean
784722|NCT00827827|Primary|Change in Non-Paretic Limb Step Length (Self-Selected)|This and other measures come from Instrumented Walkway (Gait Rite)|Baseline, 3 Months|All participants for whom measurement was recorded at Baseline and 3 months||cm||Standard Error|Mean
784723|NCT00827827|Primary|Change in Paretic Limb Step Length (Fastest)|This and other measures come from Instrumented Walkway (Gait Rite)|Baseline, 3 months|All participants for whom measurement was recorded at Baseline and 3 months||cm||Standard Error|Mean
784724|NCT00827827|Primary|Change in Paretic Limb Step Length (Self-Selected)|This and other measures come from Instrumented Walkway (Gait Rite)|Baseline, 3 Months|All participants for whom measurement was recorded at Baseline and 3 months||cm||Standard Error|Mean
784725|NCT00827827|Primary|Change in Non-Paretic Limb Step Time (Fastest)|This and other measures come from Instrumented Walkway (Gait Rite)|Baseline, 3 Months|All participants for whom measurement was recorded at Baseline and 3 months||seconds||Standard Error|Mean
784726|NCT00827827|Primary|Change in Non-Paretic Limb Step Time (Self-Selected)|This and other measures come from Instrumented Walkway (Gait Rite)|Baseline, 3 months|All participants for whom measurement was recorded at Baseline and 3 months||seconds||Standard Error|Mean
784727|NCT00827827|Primary|Change in Paretic Limb Step Time (Fastest)|This and other measures come from Instrumented Walkway (Gait Rite)|Baseline, 3 Months|All participants for whom measurement was recorded at Baseline and 3 months||seconds||Standard Error|Mean
784728|NCT00827827|Primary|Change in Paretic Limb Step Time (Self-Selected)|This and other measures come from Instrumented Walkway (Gait Rite)|Baseline, 3 months|All participants for whom measurement was recorded at Baseline and 3 months||seconds||Standard Error|Mean
785120|NCT00835081|Primary|Cmax (Maximum Observed Concentration)|Bioequivalence based on Cmax.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
784729|NCT00827827|Primary|Change in Berg Balance Scale|This measure is a 14 item scale, with each item scored (0-4) and summed for a maximum score of 56 points. Range is 0-56 and higher values represent a better outcome.|Baseline, 3 months|All participants for whom a Berg Score was recorded at Baseline and 3 months||Scores on a scale||Standard Error|Mean
784730|NCT00827827|Primary|Change in Peak Aerobic Capacity (VO2 Peak)||Baseline, 3 Months|All participants for whom Peak Aerobic Capacity was recorded during Graded Treadmill Test at Baseline and 3 months||mls/kg/min||Standard Error|Mean
784731|NCT00827827|Primary|Change in 10 Meter Walking Speed (Fastest)||Baseline, 3 Months|All participants for whom 10 Meter walking Speed (Fastest-Safe) was recorded at Baseline and 3 months||meters/ second||Standard Error|Mean
784732|NCT00827827|Primary|Change in 10 Meter Walking Speed (Self-Selected)||Baseline, 3 months|All participants for whom 10 Meter walking Speed (Self-Selected) was recorded at Baseline and 3 months||meters/ second||Standard Error|Mean
784733|NCT00827827|Primary|Change in 6-minute Walk Distance||Baseline, 3 Months|All participants for whom 6-minute walk distance was recorded at Baseline and 3 months||feet||Standard Error|Mean
784734|NCT00827827|Primary|Change in Leg Muscle Endurance (Non-Paretic Side)|Tests how training impacts the total number of submaximal repetitions a participant can perform according to standardized cadence (at the same absolute level of resistance, pre and post).|Baseline, 3 months|All participants for whom muscle endurance measurements were recorded at Baseline and 3 months||repetitions||Standard Error|Mean
784735|NCT00827827|Primary|Change in Leg Muscle Endurance (Paretic Side)|Tests how training impacts the total number of submaximal repetitions a participant can perform according to standardized cadence (at the same absolute level of resistance, pre and post).|Baseline, 3 Months|All participants for whom muscle endurance measurements were recorded at Baseline and 3 months||repetitions||Standard Error|Mean
784736|NCT00827827|Primary|Change in 1-RM Muscle Strength (Leg Extension, Non-Paretic Side)||Baseline, 3 Months|All participants for whom strength measurements were recorded at Baseline and 3 months||lbs||Standard Error|Mean
784737|NCT00827827|Primary|Change in 1-RM Muscle Strength (Leg Extension, Paretic Side)||Baseline, 3 Months|All participants for whom strength measurements were recorded at Baseline and 3 months||lbs||Standard Error|Mean
784738|NCT00827827|Primary|Change in 1-RM Muscle Strength (Leg Press, Non-Paretic Side)||Baseline, 3 months|All participants for whom strength measurements were recorded at Baseline and 3 months||lbs||Standard Error|Mean
784739|NCT00827827|Primary|Change in 1-repetition Maximum (RM) Muscle Strength (Leg Press, Paretic Side)||Baseline, 3 months|All participants for whom strength measurements were recorded at Baseline and 3 months||lbs||Standard Error|Mean
784740|NCT00827918|Secondary|Mean Change From Baseline in PANSS Negative Subscale at Week 4|PANSS Negative scale assesses emotional withdrawal, lack of motivation, and similar symptoms. The Negative scale has 7 items with an anchored Likert scale from 1 to 7 to score each item. Values of 2 and above indicate the presence of progressively more severe symptoms. A total score ranges from 7 to 49.|Baseline and Week 4|Randomized participants with any PANSS negative subscale measurements between baseline and Week 4.||Units on a scale||95% Confidence Interval|Least Squares Mean
784741|NCT00827918|Secondary|Mean Change From Baseline in PANSS Positive Subscale at Week 4|PANSS Positive scale assesses hallucinations, delusions and related symptoms. The Positive scale has 7 items with an anchored Likert scale from 1 to 7 to score each item. Values of 2 and above indicate the presence of progressively more severe symptoms. A total score ranges from 7 to 49.|Baseline and Week 4|Randomized participants with any PANSS positive subscale measurements between baseline and Week 4.||Units on a scale||95% Confidence Interval|Least Squares Mean
784742|NCT00827918|Secondary|Mean Change From Baseline in Clinical Global Impression – Severity of Illness Scale (CGI-S) at Week 4|CGI-S is a commonly used measure of symptom severity in treatment studies of participants with mental disorders. CGI-S is a 7-point scale that requires the clinician to rate the severity of the participant's illness at the time of assessment, relative to the clinician's past experience with participants who have the same diagnosis. Considering total clinical experience, a participant is assessed on severity of mental illness at the time of rating 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; or 7 = extremely ill.|Baseline and Week 4|Randomized participants with any CGI-S measurements between baseline and Week 4.||Units on a scale||95% Confidence Interval|Least Squares Mean
784743|NCT00827918|Secondary|Percentage of Participants With Response at Week 4|Responders were defined as participants who demonstrated ≥ 20% improvement from baseline on the PANSS total score. PANSS measure is composed of 3 scales: Positive scale, Negative scale, and General Psychopathology scale. Positive scale assesses hallucinations, delusions and related symptoms; Negative scale assesses emotional withdrawal, lack of motivation, and similar symptoms; and General Psychopathology scale addresses other symptoms such as anxiety, somatic concern and disorientation. The PANSS has 30 items in its 3 scales and an anchored Likert scale from 1 to 7 is used to score each item. Values of 2 and above indicate the presence of progressively more severe symptoms. The Positive scale has 7 items with a score from 7 to 49, the Negative scale has 7 items with a score from 7 to 49, and the General Psychopathology scale has 16 items with a score from 16 to 112. A total score is the sum of the 3 scores for the 3 scales.|Week 4|Randomized participants with a PANSS measurement at Week 4.||Percentage of participants|||Number
784744|NCT00827918|Primary|Number of Participants Who Discontinued Study Drug Due to an Adverse Event|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the study drug.|Up to 4 Weeks|All participants included in the All Patients as Treated (APaT) population received at least one dose of study treatment and were evaluated for safety.||Participants|||Number
784745|NCT00827918|Primary|Number of Participants Who Experienced at Least One Adverse Event|An adverse event (AE) is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the study drug.|Up to 6 Weeks|All participants included in the All Patients as Treated (APaT) population received at least one dose of study treatment and were evaluated for safety.||Participants|||Number
785075|NCT00834964|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Venlafaxine in Plasma|Bioequivalence based on AUC0-t|Blood samples collected over 24 hour period|Data from first 24 completed subjects were included in the statistical analysis per protocol.||ng*h/mL||Standard Deviation|Mean
784746|NCT00827918|Primary|Mean Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) at Week 4|PANSS is a medical scale used for measuring symptom severity of participants with schizophrenia. PANSS measure is composed of 3 scales: Positive scale, Negative scale, and General Psychopathology scale. Positive scale assesses hallucinations, delusions and related symptoms; Negative scale assesses emotional withdrawal, lack of motivation, and similar symptoms; and General Psychopathology scale addresses other symptoms such as anxiety, somatic concern and disorientation. The PANSS has 30 items in its 3 scales and an anchored Likert scale from 1 to 7 is used to score each item. Values of 2 and above indicate the presence of progressively more severe symptoms. The Positive scale has 7 items with a score from 7 to 49, the Negative scale has 7 items with a score from 7 to 49, and the General Psychopathology scale has 16 items with a score from 16 to 112. A total score is the sum of the 3 scores for the 3 scales.|Baseline and Week 4|Randomized participants with any PANSS measurements between Baseline and Week 4.||Units on a scale||95% Confidence Interval|Least Squares Mean
784747|NCT00827931|Secondary|Number of Participants With Deep Vein Thrombosis (DVT) Post Surgery|DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling and warmth.|Day 7 post-surgery|FAS population included all randomized participants in compliance with the intent-to-treat analysis principle. Participants who had no post-baseline data for a given endpoint was not included in the analysis of that endpoint.||Participants|||Number
784748|NCT00827931|Secondary|Hemoglobin Levels||End of surgery, Day 1, Day 2, Day 4 and Day 7/End of treatment (EoT) post-surgery|FAS population included all randomized participants in compliance with the intent-to-treat analysis principle. Participants who had no post-baseline data for a given endpoint was not included in the analysis of that endpoint.||Gram/Deciliter (g/dL)||Standard Deviation|Mean
784749|NCT00827931|Secondary|Percentage of Participants Receiving Transfusions|A uniform transfusion protocol was maintained for all participants in the study. Transfusion to be triggered at 8.0 milligram/deciliter (mg/dL) hemoglobin or hematocrit value of 24 percent.|Up to Day 7 post-surgery|FAS population included all randomized participants in compliance with the intent-to-treat analysis principle. Participants who had no post-baseline data for a given endpoint was not included in the analysis of that endpoint.||Percentage of participants||95% Confidence Interval|Number
784750|NCT00827931|Secondary|Total Blood Loss as Assessed by the Gross’ Formula|Gross’ formula for estimating total blood loss: Estimated blood volume multiplied by (*) [(hematocrit initial minus hematocrit final) divided by hematocrit average]; where estimated blood volume equals body weight in kilograms (kg) *70 mL/kg.|Baseline through Day 2 post-surgery|FAS population included all randomized participants in compliance with the intent-to-treat analysis principle. Participants who had no post-baseline data for a given endpoint was not included in the analysis of that endpoint.||mL||Standard Deviation|Mean
784751|NCT00827931|Secondary|Total Blood Loss|Total blood loss was defined as the sum of intra-operative and post-operative blood loss. It was measured by weighing the drapes/ dressings or swabs prior to soaking to measure difference in weight and checking drain collectors until drains were removed.|Baseline through Day 2 post-surgery|FAS population included all randomized participants in compliance with the intent-to-treat analysis principle. Participants who had no post-baseline data for a given endpoint was not included in the analysis of that endpoint.||mL||Standard Deviation|Mean
784752|NCT00827931|Secondary|Intra-operative Blood Loss|Intra-operative blood loss was measured by weighing the drapes/ dressings or swabs prior to soaking to measure difference in weight and checking drain collectors until drains were removed.|Day 1 (End of surgery)|FAS population included all randomized participants in compliance with the intent-to-treat analysis principle. Participants who had no post-baseline data for a given endpoint was not included in the analysis of that endpoint.||mL||Standard Deviation|Mean
784753|NCT00827931|Primary|Post-operative Blood Loss|Post-operative blood loss was defined as the sum of the drainage volumes measured over post-operative days 1, 2, and at drain removal. It was measured by weighing the drapes/ dressings or swabs prior to soaking to measure difference in weight and checking drain collectors until drains were removed.|Post-operation, Day 1, Day 2 up to drain removal|Full Analysis Set (FAS) population included all randomized participants in compliance with the intent-to-treat analysis principle. Participants who had no post-baseline data for a given endpoint was not included in the analysis of that endpoint.||milliliter (mL)||Standard Deviation|Mean
784754|NCT00827944|Secondary|Other Post-operative Complications||M12 after surgery|As Treated population||participants|||Number
784755|NCT00827944|Secondary|Return to Work and to Normal Daily Activities||Effective date|The analysis were performed on an As Treated (AT) population, with a 5% significance level.||days||Standard Error|Mean
784756|NCT00827944|Secondary|Wound Complications and Hernia Recurrences||M12 after surgery|The analysis were performed on an As Treated (AT) population, with a 5% significance level.||participants|||Number
784757|NCT00827944|Primary|Pain Assessment During the First Three Months and at One Year After Surgery Using a Surgical Pain Scales (SPS)|Surgical pain scales (=SPS) completed by patient during consultation or will be sent to the patient with instructions to complete it and send it back by mailing. The score of evaluation will be reported in mm, specifying if pain occurs at rest, during normal activities, during exercise. The score is ranged from 0 (no pain) to 150 mm (the worst pain yu have never known).|M3, M12 after surgery|The analysis were performed on an As Treated population (AT), with a 5% significance level.||units on a scale||Standard Deviation|Mean
784758|NCT00827944|Primary|Pain Assessment During the First Three Months and at One Year After Surgery Using a Visual Analogue Scale (VAS)|Pain assessment during patient follow up after surgery using VAS score. VAS going from 0 mm (no pain) to 150 mm (worst conceivable pain) is presented to the patient who draw a vertical line on the scale to indicate the average amount of pain at the time of consultation or at home.|M3, M12 after surgery|The analysis were performed on an As Treated (AT)population, with a 5% significance level.||units on a scale||Standard Deviation|Mean
784759|NCT00827944|Secondary|Chronic Pain Defined as Pain Lasting More Than 3 Months Using VAS Score|Chronic pain defined as pain lasting more than 3 months using VAS score. A VAS going from 0 mm (no pain) to 150 mm (worst conceivable pain) is presented to the patient who draw a vertical line on the scale to indicate the average amount of pain at the time of consultation or at home.|3 months after surgery|||participants|||Number
784760|NCT00827944|Secondary|Foreign Body Sensation|Foreign body sensation using a specific questionnaire at M1, M3, M12 months after surgery. Questionnaire will be completed by patient during consultation or will be sent to the patient with instructions to complete it and send it back by mailing.|M1, M3, M12 months after surgery|The analysis were performed on an As Treated population, with a 5% significance level.||participants|||Number
784761|NCT00827983|Secondary|Implantation Rate|Implantation rate was defined as the mean of the total number of gestational sacs seen divided by the total number of embryos transferred. Values are reported as a percentage.|Four to five weeks after oocytes retrieval|All the patients who had at least one embryo transferred||percentage of embryos transferred||Standard Deviation|Mean
784762|NCT00827983|Secondary|Delivery Rate and Live Birth Rate||nearly 9 month after treatment start|all the randomised patients were included in the analysis||percentage of randomised patients|||Number
784763|NCT00827983|Primary|Ongoing Pregnancy Rate at the End of the Study||10 weeks after treatment start|ITT population was analysed (i.e. all the randomised patients)||percentage of randomized patient|||Number
784764|NCT00828061|Secondary|Change From Baseline at Hour 8 in the Percent of Total Cells That Are Eosinophils|Comparison of the Change in the Percent of Total Cells That Are Eosinophils Measured in Nasal Lavage After a Single Dose of 10 mg or 25 mg Prednisone Relative to Placebo|Baseline and Hour 8 post nasal allergen challenge|All Patients with Slide Quality ≤ 3 (Slide Quality measured on a 6 point scale with values > 3 indicating a level of debris that interferes with cell typing and counting).||Percentage of cells that are eosinophils||95% Confidence Interval|Least Squares Mean
784765|NCT00828061|Primary|Fold Change From Baseline at Hour 8 in Interleukin 5 (IL-5) Concentration|Comparison of the Change in Allergen-induced Interleukin 5 (IL-5) as Measured in Nasal Exudates After a Single Dose of Low or High Dose of Oral Prednisone Relative to Placebo|Baseline and Hour 8 post nasal allergen challenge|All Patients as Treated||Fold Change||95% Confidence Interval|Geometric Mean
784766|NCT00828074|Secondary|Toxicity Profile|Number of Participants with Treatment-Related Grade 3 & 4 Toxicities for Sorafenib and Vinorelbine Combination|28 days following the last course of treatment|||participants|||Number
784767|NCT00828074|Secondary|Overall Survival|Estimated using the product-limit method of Kaplan and Meier.|Until death from any cause, up to 5 years.|All patients treated at the phase II vinorelbine dose (6 in the phase I portion, 35 in the phase II portion).||Months||95% Confidence Interval|Median
784768|NCT00828074|Secondary|Objective Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response Rate defined as percentage of patients achieving a Best Response of either CR or PR.|After 2 cycles of treatment, up to 2 years.|All patients treated at the phase II vinorelbine dose (6 in the phase I portion, 35 in the phase II portion). Patients who complete 2 cycles of treatment or who terminate treatment for reasons of toxicity, or who progress prior to the completion of 2 cycles of therapy on the Phase II portion of the study.||percentage of participants|||Number
784769|NCT00828074|Secondary|Progression-free Survival|Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Until disease progression, up to 5 years.|All patients treated at the phase II vinorelbine dose (6 in the phase I portion, 35 in the phase II portion).||Months||95% Confidence Interval|Median
784770|NCT00828074|Secondary|Progression-free Survival Rate at 4 Months|Estimated using the product-limit method of Kaplan and Meier.Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|4 months following the last course of treatment|All patients treated at the phase II vinorelbine dose (6 in the phase I portion, 35 in the phase II portion).||percentage of participants|||Number
784771|NCT00828074|Primary|Recommended Phase II Dose|The maximum tolerated dose (MTD) of Vinorelbine is based on toxicities observed during the first cycle and is defined as the highest dose tested in which fewer than 33% of patients experience an attributable DLT to the study drug, when at least 6 patients are treated at that dose and are evaluable for toxicity. Dose escalations proceeded according to a standard 3+3 design.|4 weeks from start of treatment, up to 2 years|All patients observed for 28 days while receiving a full course of therapy or who experienced a DLT. Patients withdrawing before completion of the first course, for reasons other than DLT, were replaced.||mg/m^2|||Number
784772|NCT00828074|Primary|Number of Participants With at Least One Dose Limiting Toxicity in Phase I|Dose Limiting Toxicity (DLT) defined as any treatment-related grade 3 or greater non-hematologic toxicity (excluding alopecia, controllable nausea and vomiting, and serum triglycerides < 1,500 mg/dL which recover within 1 week), grade 4 or greater thrombocytopenia, grade 4 or greater febrile neutropenia requiring hospitalization, or treatment delay of > 2 weeks as a result of unresolved toxicity during the first cycle of therapy.|4 weeks from start of treatment, up to 2 years|All patients receiving treatment were evaluated for DLT.||participants with DLTs|||Number
784773|NCT00828113|Primary|Number of Participants Not Smoking in the Previous 7 Days, Confirmed by Expired Carbon Monoxide Reading < 10 Parts Per Million at Week 52|Self-report of no smoking (not even a puff) in the previous seven days confirmed by an expired carbon monoxide reading of < 10 parts per million as assessed at Week 52|7-day point prevalence|Participants randomized at 12 weeks who continued in the study to Week 52 and provided CO-verified smoking status.||participants|||Number
784774|NCT00828139|Secondary|Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs|Adverse Events (AEs) are reported by CTCAE Version 3.0. Only adverse events that are possibly, probably or definitely related to study drug are reported. The events listed here are not necessary to be included in Serious Adverse Event. A serious event could be death, life-threatening, hospitalization, disability or permanent damage, congenital anomaly...Grade 3 through 5 adverse event may not meet the criterion of serious adverse event.|Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.|Eligible patients who had received the protocol treatments were included in the adverse event summaries. Ant CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.||Participants|||Number
784775|NCT00828139|Secondary|Response Rate (Confirmed and Unconfirmed, Complete and Partial Responses)|"The number of confirmed and unconfirmed complete and partial responses in the subset of patients with measurable disease per RECIST 1.0. Estimated to within at least 17% (95% confidence interval).
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by magnetic resonance imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|Disease assessment for response were performed every 6 weeks, up to 2 years.|||proportion of participants||90% Confidence Interval|Number
784776|NCT00828139|Secondary|Overall Survival|Estimated to within at least 15% (95% confidence interval).|Weekly, up to 2 years.|||months||90% Confidence Interval|Median
784777|NCT00828139|Primary|Progression-free Survival (PFS)|"From the date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause.
Progression is defined as 20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline. Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided). Appearance of any new lesion/site. Death due to disease without prior documentation of progression and without symptomatic deterioration."|Disease assessments were performed every 6 weeks, up to 2 years.|||Months||90% Confidence Interval|Median
784778|NCT00828178|Secondary|Effect on Markers of Inflammation: ICAM and VCAM by Omega-3 Versus Placebo.|The inflammatory markers (sICAM-1 and sVCAM-1) were assessed and compared before and after treatment. change from baseline were reported.|pre-treatment(baseline) and post-treatment (after 12 weeks)|||ng/ml||Standard Deviation|Mean
784779|NCT00828178|Secondary|Effect of Omega-3 Versus Placebo on Disease Activity in SLE.|"The assessment measured change in disease activities using SELENA-SLEDAI (Systemic Lupus Erythematosus Disease Activity Index Selena Modification - range 0-105) and PGA (Physician Global Assessment - range 0-3) comparing pre-treatment(baseline) vs post-treatment (after 12 weeks).
SELENA-SLEDAI - range 0-105, high score indicates high disease activity - weighted sum of sub-scale is used as total score.
PGA - range 0-3, high score indicates high disease activity."|pre-treatment(baseline) and post-treatment (after 12 weeks)|||Units on a scale||Standard Deviation|Mean
784780|NCT00828178|Primary|Effect on Brachial Artery Flow Dilation by Omega-3 Versus Placebo.|The assessment measured mean brachial artery diameter at pre-treatment(baseline) and post-treatment (after 12 weeks).|12 weeks|Patients who successfully completed the trial.||cm||Standard Deviation|Mean
784781|NCT00828191|Secondary|Delivery Rate||nearly 9 months after treatment start|All randomized patients||percentage of randomized patients|||Number
784782|NCT00828191|Secondary|Implantation Rate|Implantation rate was defined as the number of gestational sacs divided by the number of embryos transferred (%). This value was calculated for all the patients who had at least one embryo transferred.|4-5 weeks after treatment start|Patient who had at least one embryo transferred.||percentage of embryos transferred||Standard Deviation|Mean
784783|NCT00828191|Primary|Ongoing Pregnancy Rate||10 weeks after treatment start|All randomized patients were included in the analysis||percentage of randomized patients|||Number
784784|NCT00828204|Other Pre-specified|Mean Pain Score After Injection|Participants scored their pain level after the use of the manual prefilled syringe on Day 1 and the Avonex single-use autoinjector on Days 8, 15, and 22 on a scale ranging from 0 (no pain) to 10 (extremely painful).|Day 1, Day 8, Day 15, Day 22|Participants in the Main and Initial Subsets who received at least 1 dose of Avonex injection using the Avonex single-use autoinjector. Missing data were not imputed.||scores on a scale||Standard Deviation|Mean
784785|NCT00828204|Other Pre-specified|Percentage of Participants Who Indicated a Preference for the Avonex Single-use Autoinjector Over the Manual Avonex Prefilled Syringe|Participants were asked whether they preferred using the Avonex single-use autoinjector over the manual Avonex prefilled syringe. Preference was defined as participants answering yes to the following question: Do you prefer this single-use autoinjector over the manual injection?|Day 23|Participants who received at least 1 injection with autoinjector and had a complete questionnaire. Missing data were not imputed.||percentage of participants|||Number
784786|NCT00828204|Other Pre-specified|Percentage of Participants Who Indicated No Difficulty With the Injection Procedure of the Manual Injection or the Avonex Single-use Autoinjector|"Participants assessed whether they had experienced any difficulty with the procedure in preparing, injecting, removing, and disposing process after each injection with the Avonex single-use autoinjector by answering yes or no to the following question: Did you have any difficulty with your injection? The percentage of participants answering no to this question for both the manual injection on Day 1 and the autoinjector on Days 8. 15 and 22 are presented."|Day 1, Day 8, Day 15, Day 22|Participants in the Main Subset who received at least one injection with the Avonex single-use autoinjector and submitted an assessment of injection procedure form. Missing data were not imputed. n=number of participants with assessment at the given timepoint.||percentage of participants|||Number
784787|NCT00828204|Other Pre-specified|Mean Score for Initial Subset on Autoinjector Instructions Grading Scale|"Participants in the Initial Subset were asked to answer the question How satisfied are you with the presentation of the autoinjector instructions? on a rating scale of 0 (extremely dissatisfied) to 10 (extremely satisfied)."|Day 8|Participants in the Initial Subset who received at least one injection with the Avonex single-use autoinjector and completed the grading scale.||scores on a scale||Standard Deviation|Mean
784788|NCT00828204|Other Pre-specified|Percentage of Participants Who Rated the Avonex Single-use Autoinjector Printed and DVD Training Materials as Very Effective|Participants evaluated how effective the printed and DVD instructions were in educating how to use the Avonex single-use autoinjector. Participants could choose one of the following descriptive answers: not effective at all, somewhat ineffective, neutral, somewhat effective, or very effective.|Day 8, Day 15, Day 22|Participants in the Main Subset who received at least one injection with the Avonex Single-use Autoinjector and submitted an assessment form. n=the number of subjects completing the assessment form at the given timepoint. Missing data were not imputed.||percentage of participants|||Number
784851|NCT00821964|Secondary|Incidence of Reduction of Serum TGF-beta Levels as Assessed by ELISA and Correlation With Th1 Adaptive Immunity and Clinical Response|Incidence of reduction of serum TGF-beta levels as assessed by ELISA and correlation with Th1 adaptive immunity and clinical response is defined as a reduction of at least 25% from baseline value to the value measured at week 13.|Baseline and at weeks 13 and 24||||||
784789|NCT00828204|Other Pre-specified|Mean Score for Ease of Use Grading Scale|Participants scored the ease of use of the Avonex manual injector (Day 1) and single-use autoinjector (Days 8, 15, 22) using a scale that ranged from 0 (extremely difficult) to 10 (extremely easy).|Day 1, Day 8, Day 15, Day 22|Participants who received at least one injection with the Avonex Single-use Autoinjector. Missing data were not imputed. n=number of participants who received an injection and had an assessment at the given timepoint.||scores on a scale||Standard Deviation|Mean
784790|NCT00828204|Other Pre-specified|Percentage of Participants With No Erythema, Induration, or Tenderness, and Normal Temperature at the Injection Site After Injection With the Avonex Single-use Autoinjector|The clinician/investigator evaluated the injection site for erythema, induration, and tenderness as none, mild, moderate, or severe after the use of the Avonex single-use autoinjector. Temperature at the injection site was evaluated as normal, warm, or hot. Those participants having no erythema, induration, or tenderness, and normal temperature at the injection site after injection are presented.|Day 1, Day 8 through 22 (highest severity reported between Days 8 and 22)|Participants who received at least one injection with the Avonex single-use autoinjector. Missing data were not imputed.||percentage of participants|||Number
784791|NCT00828204|Other Pre-specified|Number of Participants in the Initial Subset Who Were Satisfied With the Avonex Single-Use Autoinjector|"Number of participants in the Initial Subset who answered yes to the question Were you satisfied with this single-use injector? on the Subject Satisfaction Questionnaire."|Day 23|Participants in the Initial Subset who received at least 1 injection with autoinjector who had a complete Subject Satisfaction Questionnaire.||participants|||Number
784792|NCT00828204|Primary|Percentage of Participants in the Main Subset With Overall Success Using the Avonex Single-Use Autoinjector|A trainer/observer documented the participant's ability to self-inject with the Avonex single-use autoinjector and completed an observation form. Overall success in using the device for each participant was defined as no failures occurring in any step (ie, device set-up, self-administration of injection, and capping/disposal of the device) during the participant's use of the single-use Avonex autoinjector.|Day 22|Participants in the Main Subset who received an injection of Avonex prefilled syringe as a manual IM injection, at least 1 injection of Avonex prefilled syringe using the autoinjector, and had a completed Observation Form were included in the analysis. Missing data were not imputed. All analyses are based on observed data.||percentage of participants||95% Confidence Interval|Number
784793|NCT00828295|Secondary|Proportion of Patients With Complete Response 0-24 Hours|Complete Response defined as no vomiting, no retching, and no use of rescue medication|0-24 hours|Full Analysis Set||percentage of patients||95% Confidence Interval|Number
784794|NCT00828295|Primary|Proportion of Patients With no Emetic Episodes in the Overall Time Period 0-72 Hours Post-operatively||0-72 hours post-operatively|The Full Analysis Set (FAS) included all randomized patients, who received the study drug, had general anesthesia and surgery. Following the intent-to-treat principle, patients were assigned to the study treatment group according to the treatment to which they were randomized.||percentage of patients||95% Confidence Interval|Number
784795|NCT00828308|Primary|Prostate-Specific Antigen (PSA) Response|Decrease in PSA:number of participants with decreased serum PSA level after 12 weeks of ixabepilone|after 12 weeks of ixabepilone|||participants|||Number
784796|NCT00828321|Secondary|AUC0-72 (Area Under the Concentration-time Curve From Time Zero to Time 72 Hours)of Ramiprilat.|Informational comparison of AUC0-72 values for the metabolite Ramiprilat.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
784797|NCT00828321|Secondary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)of Ramiprilat.|Informational comparison of Cmax values for the metabolite Ramiprilat.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg/mL||Standard Deviation|Mean
784798|NCT00828321|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)of Ramipril.|Bioequivalence based on AUC0-t for Ramipril.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
784799|NCT00828321|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)of Ramipril|Bioequivalence based on AUC0-t of Ramipril.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
784800|NCT00828321|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)of Ramipril|Bioequivalence based on Cmax of Ramipril.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg/mL||Standard Deviation|Mean
784801|NCT00828347|Primary|Number of Participants With iPTH Levels Maintained at the Target Levels of 60-180 pg/mL iPTH Level||Participants were followed for 24 weeks|||participants|||Number
784802|NCT00828412|Primary|Change From Baseline in Three Item Severity Score|The average of the sum of scores for erythema, edema/papulation, and excoriation for two target lesions. Scoring on a scale of 0 to 3 (none to severe). Maximum score is 9.|Baseline to 6 weeks|All subjects with data were included in the analysis. No imputation was done for missing data.||units on a scale||Standard Deviation|Mean
784803|NCT00828464|Secondary|Change in Subject’s Visual Analogue Assessment Scale From Baseline to Day 15|Mean change in subject’s visual analogue assessment scale from baseline to day 15. At each visit, the subject is requested to rate the changes in their skin on the hands on a 1 to 10 scale with 0 being poor and 10 being excellent.|Baseline, Day 15|ITT||Units on a scale||Standard Deviation|Mean
784804|NCT00828464|Secondary|Proportion of Subjects at Day 15 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Wrists|"Proportion of Subjects at Day 15 with at least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI)for All Symptoms Present at Baseline Wrists.
The proportion of participants is being reported as a percentage of participants.
Each hand was divided into five areas [fingertips, fingers (except the tips), palms, back of hands and wrists]. For each of these areas the intensity of the 6 following clinical signs: erythema, induration, papulation, vesicles, fissuring, scaling and oedema was graded as follows: 0, no skin changes; 1, mild disease; 2, moderate and 3, severe."|Baseline, Day 15|ITT||Percentage of Participants|||Number
785076|NCT00834964|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Venlafaxine in Plasma|Bioequivalence based on AUC0-inf|Blood samples collected over 24 hour period|Data from first 24 completed subjects were included in the statistical analysis per protocol.||ng*h/mL||Standard Deviation|Mean
784805|NCT00828464|Secondary|Proportion of Subjects at Day 8 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Wrists|"Proportion of Subjects at Day 8 with at least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Wrists.
The proportion of participants is being reported as a percentage of participants.
Each hand was divided into five areas [fingertips, fingers (except the tips), palms, back of hands and wrists]. For each of these areas the intensity of the 6 following clinical signs: erythema, induration, papulation, vesicles, fissuring, scaling and oedema was graded as follows: 0, no skin changes; 1, mild disease; 2, moderate and 3, severe."|Baseline, Day 8|ITT||Percentage of Participants|||Number
784806|NCT00828464|Secondary|Proportion of Subjects at Day 15 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Back of Hands|"Proportion of Subjects at Day 15 with at least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Back of Hands.
The proportion of participants is being reported as a percentage of participants.
Each hand was divided into five areas [fingertips, fingers (except the tips), palms, back of hands and wrists]. For each of these areas the intensity of the 6 following clinical signs: erythema, induration, papulation, vesicles, fissuring, scaling and oedema was graded as follows: 0, no skin changes; 1, mild disease; 2, moderate and 3, severe."|Baseline, Day 15|ITT||Percentage of Participants|||Number
784807|NCT00828464|Secondary|Proportion of Subjects at Day 8 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Back of Hands|"Proportion of Subjects at Day 8 with at least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Back of Hands.
The proportion of participants is being reported as a percentage of participants.
Each hand was divided into five areas [fingertips, fingers (except the tips), palms, back of hands and wrists]. For each of these areas the intensity of the 6 following clinical signs: erythema, induration, papulation, vesicles, fissuring, scaling and oedema was graded as follows: 0, no skin changes; 1, mild disease; 2, moderate and 3, severe."|Baseline, Day 8|ITT||Percentage of Participants|||Number
784808|NCT00828464|Secondary|Proportion of Subjects at Day 15 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Palm of Hands|"Proportion of Subjects at Day 15 with at least a 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Palm of Hands The proportion of participants is being reported as a percentage of participants.
Each hand was divided into five areas [fingertips, fingers (except the tips), palms, back of hands and wrists]. For each of these areas the intensity of the 6 following clinical signs: erythema, induration, papulation, vesicles, fissuring, scaling and oedema was graded as follows: 0, no skin changes; 1, mild disease; 2, moderate and 3, severe."|Baseline, Day 15|ITT||Percentage of Participants|||Number
784809|NCT00828464|Secondary|Proportion of Subjects at Day 8 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Palm of Hands|"Proportion of Subjects at Day 8 with at least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline - Palm of Hands.
The proportion of participants is being reported as a percentage of participants.
Each hand was divided into five areas [fingertips, fingers (except the tips), palms, back of hands and wrists]. For each of these areas the intensity of the 6 following clinical signs: erythema, induration, papulation, vesicles, fissuring, scaling and oedema was graded as follows: 0, no skin changes; 1, mild disease; 2, moderate and 3, severe."|Baseline, Day 8|ITT||Percentage of Participants|||Number
784810|NCT00828464|Secondary|Proportion of Subjects With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Fingers|"Proportion of Subjects at day 8 with at least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline - Fingers
The proportion of participants is being reported as a percentage of participants.
Each hand was divided into five areas [fingertips, fingers (except the tips), palms, back of hands and wrists]. For each of these areas the intensity of the 6 following clinical signs: erythema, induration, papulation, vesicles, fissuring, scaling and oedema was graded as follows: 0, no skin changes; 1, mild disease; 2, moderate and 3, severe."|Baseline, Day 8|ITT||Percentage of Participants|||Number
784811|NCT00828464|Secondary|Proportion of Subjects at Day 15 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline - Fingers|"Proportion of Subjects at day 15 with at least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Fingers.
The proportion of participants is being reported as a percentage of participants.
Each hand was divided into five areas [fingertips, fingers (except the tips), palms, back of hands and wrists]. For each of these areas the intensity of the 6 following clinical signs: erythema, induration, papulation, vesicles, fissuring, scaling and oedema was graded as follows: 0, no skin changes; 1, mild disease; 2, moderate and 3, severe."|Baseline, Day 15|ITT||Percentage of Participants|||Number
784812|NCT00828464|Secondary|Proportion of Subjects at Day 8 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Finger Tips|"Proportion of Subjects at day 8 with at least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Finger Tips
The proportion of participants is being reported as a percentage of participants.
Each hand was divided into five areas [fingertips, fingers (except the tips), palms, back of hands and wrists]. For each of these areas the intensity of the 6 following clinical signs: erythema, induration, papulation, vesicles, fissuring, scaling and oedema was graded as follows: 0, no skin changes; 1, mild disease; 2, moderate and 3, severe."|Baseline, Day 8|ITT||Percentage of Participants|||Number
784813|NCT00828464|Secondary|Proportion of Subjects at Day 15 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Finger Tips|"Proportion of subjects at day 15 with at least 1-Grade improvement in the Hand Eczema Severity Index Score (HESI) for all symptoms present at baseline - Finger Tips. The proportion of participants is being reported as a percentage of participants.
Each hand was divided into five areas [fingertips, fingers (except the tips), palms, back of hands and wrists]. For each of these areas the intensity of the 6 following clinical signs: erythema, induration, papulation, vesicles, fissuring, scaling and oedema was graded as follows: 0, no skin changes; 1, mild disease; 2, moderate and 3, severe."|Baseline, Day 15|ITT||Percentage of Participants|||Number
784814|NCT00828464|Secondary|Change in Subject’s Visual Analogue Assessment Scale|Mean change in subject’s visual analogue assessment scale from baseline to day 8. At each visit, the subject is requested to rate the changes in their skin on the hands on a 1 to 10 scale with 0 being poor and 10 being excellent.|Baseline, Day 8|ITT. Twenty-nine of the 30 subjects enrolled on this study had results for this endpoint on day 8. Thirty of the 30 subjects enrolled had results for this same assessment at the day 15 visit.||Units on a scale||Standard Deviation|Mean
784815|NCT00828464|Primary|Proportion of Subjects With at Least 1-grade Improvement From Baseline to Day 15 in Investigator's Static Global Assessment Score (ISGA) Score|"Proportion of Subjects with at least a 1-Grade Improvement from Baseline to Day 15 In Investigator's Static Global Assessment Score (ISGA) - Chronic Hand Dermatitis Please note that the proportion of participants is being reported as a percentage of participants.
ISGA grades:
Score = 0 (Clear) Score = 1 (Almost Clear) Score = 2 (Mild) Score = 3 (Moderate) Score = 4 (Severe)"|Baseline, Day 15|Intent-to-treat (ITT).||Percentage of Participants|||Number
784816|NCT00828464|Secondary|Proportion of Subjects Who Achieve at Least a 1-grade Improvement Based on the ISGA at Day 8.|"Please note that the proportion of participants is being reported as a percentage of participants.
Investigator's Static Global Assessment Score (ISGA) At least 1-grade improvement (%) at Day 8
ISGA grades:
Score = 0 (Clear) Score = 1 (Almost Clear) Score = 2 (Mild) Score = 3 (Moderate) Score = 4 (Severe)"|Baseline, Day 8|ITT||Percentage of Participants|||Number
784817|NCT00828516|Primary|Change From Baseline in Patient-specified and Reported Symptoms on the Measure Yourself Medical Outcome Profile|MYMOP is a questionnaire widely used for evaluating interventions based on holistic and participative principles. It enables respondants to specify and measure the treatment outcomes that are important to them.|Before the 13th acupuncture treatment|This was the number of participants who continued to, and completed, Series 2 of the treatments||units on a scale||Standard Deviation|Mean
784818|NCT00828516|Primary|Change From Baseline in Patient-specified and Reported Symptoms on the Measure Yourself Medical Outcome Profile (MYMOP)|MYMOP is a questionnaire widely used for evaluating interventions based on holistic and participative principles. It enables respondants to specify and measure the treatment outcomes that are important to them.|Before 7th acupuncture treatment|All participants completing 6 acupuncture treatments were analysed||units on a scale||Standard Deviation|Mean
784819|NCT00828542|Secondary|Maternal (Clinical and Metabolic) and Neonatal (Clinical) Safety Regarding the Use of the Etonogestrel Implant During the Immediate Postpartum Period and the First 12 Weeks Postpartum|Evaluation during the immediate postpartum period was performed at the hospital 24–48 h after delivery, in the morning and after a 12-h fast. Women and newborns were both weighed (Kg), and the blood pressure (mmHg), waist circumference (WC) (cm) and height (m) of the women were each measured by the same observer. Peripheral blood samples (20 mL) were collected and processed within 2 h after being collected. After clotting the serum, samples were centrifuged at room temperature for 10 min, and the sera were stored at −80°C until they were used for the simultaneous determination of all variables except for the complete blood count, which was performed before clotting. The following variables were analyzed: fasting serum glucose; total cholesterol (TC), high density lipoprotein (HDL) cholesterol, and triglycerides (TG), and low density lipoprotein (LDL) cholesterol|12 weeks||||||
784820|NCT00828542|Primary|Etonogestrel-releasing Contraceptive Subdermal Implant Inserted During the Immediate Puerperium Effects on the Hemostatic System of Healthy Women Over a Period of Twelve Weeks|"Activated protein C (APC) resistance is the most important marker of coagulation system in women using hormonal contraceptive methods.
APC resistance was determined by testing the effect of APC on the endogenous thrombin potential (ETP) using the Calibrated Automated Thrombogram® (CAT) assay. The sensitivity ratio or APC (APCsr) of each plasma sample was determined in the presence or absence of approximately 4 nM APC (Enzyme Research Laboratories, Swansea, United Kingdom). The APC concentration was adjusted to maintain the residual thrombin generation activity in normal pooled plasma at approximately 10%. Normal pooled plasma was run in parallel on each plate.
The normalized ratio (nAPCsr) was determined by dividing the APCsr of an individual sample by the APCsr of the pooled plasma.
Thus, nAPCsr >1.0 indicated APC resistance."|12 weeks|||ratio||Standard Deviation|Mean
784821|NCT00828568|Primary|Number of Participants in Intention-to-treat (ITT)Population With 100% Clearance of Actinic Keratosis (AK) Lesions Identified at Baseline|"Uses ITT population. Three patients (1 Imiquimod 5% Taro and 2 Imiquimod Aldara) did not have a follow-up visit after dosing and were excluded from ITT. Three patients (2 Imiquimod 5% Taro and 1 Imiquimod Aldara) were not evaluable at the 24-week visit and were not in the analysis.
Each patient is assessed at 24 weeks. Actinic keratosis (AK) lesions that were identified and measured at baseline are reevaluated at the conclusion of the study. If all lesions that were identified at baseline are no longer present and there are no new lesions, the patient is 100% clear of AK lesions."|24 weeks|Intention to Treat (ITT) Population||Participants|||Number
784822|NCT00828568|Secondary|Patients Reporting at Least One Adverse Event|For all patients who received a single dose, adverse events were collected at each follow-up visit. Any patient reporting a single or multiple adverse events at any visit was conisdered to have had at least one adverse event.|24 weeks|Safety group includes all patients who received a single dose||Participants|||Number
784823|NCT00828568|Primary|Number of Participants With 100% Clearance of Actinic Keratosis Lesions: Comparison of Taro Imiquimod 5% and Aldara-Imiquimod 5%|"Uses per protocol (PP) population.
Each patient is assessed at 24 weeks. Actinic keratosis (AK) lesions that were identified and measured at baseline are reevaluated at the conclusion of the study. If all lesions that were identified at baseline are no longer present and there are no new lesions, the patient is 100% clear of AK lesions."|24 weeks|Per Protocol (PP) population||Participants|||Number
784824|NCT00821327|Secondary|Ovarall Survival (OS)|OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.|2 years|ITT population||months||95% Confidence Interval|Median
784825|NCT00821327|Secondary|Progression-free Survival|"PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date.
Progression (PD) is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions."|2 years|ITT population||Month||Full Range|Median
784826|NCT00821327|Primary|Objective Response Rate (ORR, CR+PR) in Patients With Advanced/Metastatic UC Treated With the Combination of Gemcitabine, Cisplatin, and Sunitinib.|Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.|2 years|All eligible patients who meet the protocol-specified efficacy analyses requirements and who have received at least 1 dose of study drug.||Percentage of participants||95% Confidence Interval|Number
784827|NCT00821431|Secondary|Healing Measured by Number of Subjects Healed During the 12 Week Study Period||12 weeks|||Number of subjects healed|||Number
784828|NCT00821431|Primary|Safety Measured by the Number of Subjects With Adverse Events (Including Any Deterioration of Ulcer)||12 Weeks|||Number of Subjects with Adverse Events|||Number
784829|NCT00821509|Primary|Cumulative Number of Reported Episodes of Infectious Disease in the Arm Over the Total Number of Follow-up Weeks in the Arm|Participants reported weekly through an internet questionnaire symptoms of respiratory tract (RTI) or gastrointestinal tract infections (GTI). Individual weekly reports were combined in a single continuum and successive days with either RTI or GTI symptoms were designated as disease episodes due. Numbers of RTI, GTI and either episodes in each trial arm were calculated, and for the respective proportion, were divided by the total number of weekly reports collected in the arm.|At the end of the study period (16 months)|Number of participants given is the number at the onset. There were both lost-to-follow-up and new recruits. The analysis is, however, based on episodes of days-off in entire arm during the entire follow-up time rather than on individual participants||Disease episodes|Participants||Number
784830|NCT00821509|Primary|Cumulative Number of Reported Days-off Episodes in the Arm Due to Own Infectious Disease Over the Total Number of Follow-up Weeks in the Arm|Participants reported weekly through an internet questionnaire symptoms of respiratory tract (RTI) or gastrointestinal tract infections (GTI) as well as whether they were working (if expected) or not, daily for the previous calendar week. Individual weekly reports were combined in a single continuum and successive days with both symptoms and absence from work were designated as days-off episodes due to own infectious disease. Number of these episodes in each trial arm was calculated and for the respective proportion, was divided by the total number of weekly reports collected in the arm.|At the end of the entire study period (16 months)|Number of participants given is the number at the onset. There were both lost-to-follow-up and new recruits. The analysis is, however, based on episodes of days-off in entire arm during the entire follow-up time rather than on individual participants||sick-leave episodes|Participants||Number
784831|NCT00821587|Primary|Hepatitis C Viral Level|Undetectable or <100 COPIES/ML|6 months after completion of interferon based therapy|Randomization was performed using computer-generated random numbers. 150 patients were eligible and 39 met entry criteria for enrollment in the study. Subjects with HCV recurrence (Ishak Stage2) were randomized to TAC or to change to CsA before initiation of therapy with PEGa-2a and ribavirin for 48 weeks for genotype-1,or 24 weeks for genotype-3.||Participants|||Number
784832|NCT00821678|Secondary|Received at Least 8 Sessions of Exposure Based Therapy|0 - received <8 sessions of exposure based therapy; 1 - received >=8 sessions of exposure based therapy|12 months|||participants|||Number
784833|NCT00821678|Secondary|Medication Adherence, Defined as Taking Medication <80% of Days|0 - taking medication <80% of days; 1 - taking medications >=80%|6 months|||participants|||Number
784834|NCT00821678|Secondary|Satisfaction With Care (ECHO)||6 months||12/2016||||
784835|NCT00821678|Secondary|Change in Continuous Measure of Quality of Life (QWB)|range - 0-1 (higher score represents greater wellbeing)|6 months||12/2016||||
784836|NCT00821678|Secondary|Change in Continuous Measure of Health Status (SF12V PCS)|range - 0-100 (higher score represents greater physical health status)|6 months|||units on a scale||Standard Deviation|Mean
784837|NCT00821678|Secondary|Change in Continuous Measure of Alcohol Use (Audit Score)|range - 0-12 (higher score represents greater severity)|6 months|||units on a scale||Standard Deviation|Mean
784838|NCT00821678|Secondary|Change in Continuous Measure of Depression Symptom Severity (SCL-20)|range - 0-4 (higher score represents greater severity|6 months|||units on a scale||Standard Deviation|Mean
784839|NCT00821678|Primary|Change in PTSD Symptom Severity (PDS)|range - 0-51 (higher score represents greater severity)|Baseline, 6 months|||units on a scale||Standard Deviation|Mean
784840|NCT00821821|Secondary|mRS, NIHSS, Barthel Index||throughout study||||||
784841|NCT00821821|Secondary|Plasma MCI-186 Pharmacokinetics|The geometric mean values of MCI-186 plasma concentration at the end of the infusion (at 72h) in cohorts 1 and 2 were determined.|72 hours|The subjects with reliable measured values for plasma concentration were selected for pharmacokinetic analysis: 5 subjects in MCI-186 Cohort 1 and 11 subjects in MCI-186 Cohort 2.||ng / ml||Geometric Coefficient of Variation|Geometric Mean
784842|NCT00821821|Primary|Number of Participants That Experienced Adverse Events|Additional Outcome Measures are included in Tables for Serious Adverse Events and Other Adverse Events to report their numbers and frequency.|87days|||participants|||Number
784843|NCT00821873|Primary|MRI to Evaluate Success of Outcome.|"The CR-Plug to repair the harvest site defect left during the OATS procedure, the harvest site will be evaluated at 24 months post-operatively.
The MRI scans were evaluated by a radiologist for several categories and these were then scored and transformed to an index, resulting in an outcome score ranging from 0-100 In this scale, 0 is the worst possible and 100 is the best possible score."|24 months|||units on a scale||Standard Deviation|Mean
784844|NCT00821886|Secondary|Overall Survival|Defined as the time between Day 1 Cycle 1 to date of death from any cause.|approximately 48 months|||months||95% Confidence Interval|Number
784845|NCT00821886|Secondary|Disease-free Survival|Defined as the interval from the first date of study treatment until the date of tumor recurrence or death from any cause|expected average 18 months|||months||95% Confidence Interval|Median
784846|NCT00821886|Secondary|Number of Subjects With Adverse Events as a Measure of Safety and Toxicity|Assessment based on the frequency of treatment-related adverse events according to NCI CTCAE criteria v3.0.|Day 1 of each 3 week cycle up to 6 cycles , and every 9 weeks post-surgery until treatment discontinuation|Includes eligible patients||participants|||Number
784847|NCT00821886|Primary|Pathologic Complete Response (pCR)|Proportion of patients who do not exhibit residual invasive breast cancer in breast or axillary lymph nodes at time of surgery|average18 months|Patients who underwent surgery per protocol||participants|||Number
784848|NCT00821951|Secondary|Vorinostat Modification of the DNA Damage Response in Patient Samples||1 Year||||||
784852|NCT00821964|Secondary|Endogenous Immunity to Common Breast Tumor Antigens (HER2, IGFBP-2, Topoisomerase II-alpha, and p53) in Peripheral Blood as Assessed by IFN-gamma and ELISPOT Assay|Peripheral blood will be obtained at baseline, after cycle 3 (end of study treatment) and at week 24 (end of study) to assess the immune response. A positive antigen-specific T cell immune response will be defined as a T cell precursor frequency more robust than 1:20,000 PBMC if the patients did not have a detectable response prior to treatment. In patients with a pre-existent immune response, the development of an immune response twice baseline will constitute augmentation.|Baseline and at weeks 13 and 24||||||
784853|NCT00821964|Primary|Pathologic Response by Immunohistochemical (IHC)as Assessed by Skin Punch Biopsy of the Target Lesion|This is done by IHC staining reviewed by a pathologist. This is done by comparing the baseline to the post-treatment biopsy tissue. Yes equals absence of residual disease.|Pre-and post-treatment|||Participants|||Count of Participants
784854|NCT00821964|Primary|Safety and Systemic Toxicity as Assessed by a Review of Medical History, Physical Exam, Systems, Performance Status, and Clinical Labs (CBC and CMP)|"Evaluated according to the Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 and monitoring of adverse events will be done per Food and Drug Administration (FDA) and National Cancer Institute (NCI) guidelines for the time frame below.
Patients had a physical exam, per the time frame below, where the patient would be asked if they experienced any events under the following CTCAE categories:
Constitutional (Fatigue) Neurological (Neuropathy (sensory or motor)) Cardiac (Arrhythemia) Pulmonary (Cough, Pharyngitis) GI (Constipation, Diarrhea, Mucositis, Vomiting) Dermatology (Ulceration, Hairloss/alopecia) Pain (Headache, other pain) Syndrome (Flu-like) Visual Changes Hearing/Auditory Edema Other (General)
In addition they were asked the severity of the event so that a clinician could grade the event."|Baseline and weeks 5, 9 13, 16, 20, and 24|||Participants|||Count of Participants
784855|NCT00821964|Primary|Anti-tumor Effects of Imiquimod as Assessed by Modified World Health Organization (WHO) Criteria|"Tumor responses will be determined using the sum of the products of the largest perpendicular dimensions. Target lesions will be evaluated by the following response criteria: complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD).
Evaluation of target lesions per modified WHO response criteria:
Complete response (CR): complete clearance (100%) of target lesion(s)
Partial response (PR): ≥ 50% decrease in target lesion size
Stable disease (SD): < 50% decrease in target lesion size
Progressive (PD): ≥ 25% increase in target lesion size Overall Response Rate (ORR) determined at end of study treatment which was 1 week after cycle #3, unless patient was withdrawn from study. If patient was withdrawn from study, then ORR was determined after their last cycle of treatment received."|Baseline and then every 4 weeks until week 24|||Participants|||Count of Participants
784856|NCT00828711|Secondary|Time to Onset of Active Labor||Interval from study drug administration to active labor (average 12 hours)|Kaplan-Meier Estimates for Time to Onset of Active Labor presented (Modified Intention-to-Treat population). Subjects who never went into active labor during the first hospitalization were censored using the longest time interval from study drug administration to delivery (Censored subjects = MVI 100: 5; MVI 150: 7; MVI 200: 8)||minutes||95% Confidence Interval|Median
784857|NCT00828711|Secondary|Time of Maximum Plasma Concentration (Tmax), Maximum Plasma Concentration (Cmax), Area Under the Curve (AUC) and Terminal Half Life of Misoprostol Acid.|The timepoints over which the pharmacokinetic measurements were assessed, and deemed as accurate and appropriate, were as follows: 0 hours (baseline), 2, 4, 6, 8, 10 and 14 hours after insertion of the study drug, immediately prior to removal of the study drug and 0.5, 1 and 2 hours after removal of the study drug.|From study drug insertion up to 2 hours post study drug removal|The plan was to enrol 24 subjects to the pharmacokinetic (PK) arm of the study. Only 3 subjects enrolled in the PK arm; there were too few subjects and too few samples available. Due to insufficient data, no statistical analysis was possible. Only misoprostol acid levels for each blood sampling timepoint for each subject was determined.||PK Parameters|||Number
784858|NCT00828711|Secondary|Use of Oxytocin|Percentage of participants in receipt of Oxytocin for induction after study drug removal is accurate and appropriate for this outcome measure.|At least 30 minutes after study drug removal|Percentage of subjects who required pre-delivery oxytocin is presented (Modified Intention-to-Treat population).||percentage of participants||95% Confidence Interval|Number
784859|NCT00828711|Secondary|Cervical Ripening Using Composite Measure of Success|"Cervical ripening success was defined by achievement of one or more of the following by 12 hours after study drug administration:
Increase from baseline in modified Bishop score ≥3; or
Achievement of modified Bishop score of ≥6; or
Vaginal delivery."|12 hours after insertion of drug|Percentage of subjects with cervical ripening success at 12 hours is presented (Modified Intention-to-Treat population).||percentage of participants||95% Confidence Interval|Number
784860|NCT00828711|Secondary|Proportion of Cesarean Delivery||Interval from study drug administration to cesarean delivery (average 24 hours)|Percentage of subjects who had a cesarean delivery during the first hospitalization (safety population) is presented.||percentage of participants||95% Confidence Interval|Number
784861|NCT00828711|Secondary|Rate of Adverse Events|All adverse events were rated by the Investigator as mild, moderate or severe and classified as having no relationship, possible relationship or a probable relationship to the study drug. These assessments were deemed as accurate and appropriate for the reporting of all serious and non serious adverse events.|From study drug administration to hospital discharge (approximately 48 - 72 hours)|The percentage of subjects with adverse events are presented for the Intrapartum (before delivery), postpartum (maternal) and neonatal periods.||percentage of participants|||Number
784862|NCT00828711|Secondary|Time to Vaginal Delivery||Interval from study drug administration to delivery (average 24 hours)|Kaplan-Meier Estimates are based on Modified Intention-to-Treat (MITT) population.Subjects who had a cesarean, discharged prior to delivery or withdrew consent during first hospitalization were censored (MVI 100: 37, MVI 150: 39, MVI 200: 31) using the longest time interval from study drug administration to cesarean or to Labor & Delivery discharge||minutes||95% Confidence Interval|Median
784863|NCT00828711|Primary|Proportion of Women Delivering Vaginally||Interval from study drug administration to 24 hours|Analysis based on Modified Intention-to-Treat (MITT) population who delivered vaginally. Percentage of subjects who delivered vaginally is presented.||percentage of participants||95% Confidence Interval|Number
785077|NCT00834964|Primary|Cmax - Maximum Observed Concentration - Venlafaxine in Plasma|Bioequivalence based on Cmax|Blood samples collected over 24 hour period|Data from first 24 completed subjects were included in the statistical analysis per protocol.||ng/mL||Standard Deviation|Mean
784864|NCT00828750|Secondary|Percentage of Participants Initiating Rescue Medication/Treatment During On-Therapy|Rescue therapy included new ITP medication, an increased dose of a concomitant ITP medication from Baseline (B/L), platelet transfusion, and splenectomy.|From Baseline (Day 1) to last dose of eltrombopag/early withdrawal visit (up to 981 days)|FAS||percentage of participants|||Number
784865|NCT00828750|Secondary|Percentage of Participants With a Reduction in Use of Baseline Idiopathic Thrombocytopenic Purpura (ITP) Medication|Concomitant ITP medications included drugs such as steroids and immunosuppressive drugs. Reduction of concomitant ITP medication was defined as a reduction in dose and/or frequency of administration.|From Baseline (Day 1) to last dose of eltrombopag/early withdrawal visit (up to 981 days)|FAS. A total of 15 participants who received at least one concomitant ITP medication at Baseline were included in the analysis.||percentage of participants|||Number
784866|NCT00828750|Secondary|Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication|Any bleeding(s) with an onset on or after the start date of study medication was recorded as a bleeding episode(s).|Baseline; Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112, 116, 120, 124, 128, 132, and 136; and last visit/early withdrawal visit (up to Day 982)|FAS. The number of participants analyzed varies by week because some participants prematurely withdrew and the timing of the evaluation differs among participants.||percentage of participants|||Number
784867|NCT00828750|Secondary|Median Number of Maximum Continuous Weeks of Maintaining Platelet Counts Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count at Three-Month Intervals|Maximum continuous week is measured as the longest period (weeks) for which a participant continuously maintained platelet counts greater than or equal to 50 Gi/L and greater than or equal to twice the Baseline count.|3, 6, 9, 12, 15, 18, 21, 24, 27, and 30 months (13, 26, 39, 52, 65, 78, 91, 104, 117, and 130 weeks)|FAS. The number of participants analyzed varies by category of months (weeks) on study medication because the duration of study medication differs among participants.||weeks||Full Range|Median
784868|NCT00828750|Secondary|Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)|Maximum continuous week (MCW) is measured as the longest period (weeks) for which a participant continuously maintained platelet counts greater than or equal to 50 Gi/L and greater than or equal to twice the Baseline count.|From Baseline (Day 1) to last dose of eltrombopag/early withdrawal visit (up to 981 days)|FAS. The number of participants analyzed varies by category of weeks on study medication because the duration of study medication differs among participants.||percentage of participants|||Number
784869|NCT00828750|Secondary|Median Platelet Counts|Platelet counts were measured by blood draw.|Baseline; Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112, 116, 120, 124, 128, 132, and 136; and last visit/early withdrawal visit (up to Day 982)|FAS. The number of participants analyzed varies by week because some participants prematurely withdrew and the timing of the measurement differs among participants.||Gi/L||Full Range|Median
784870|NCT00828750|Secondary|Percentage of Participants Achieving a Platelet Count Greater Than or Equal to 50 Giga Unit (10^9) Per Liter (Gi/L) and Less Than or Equal to 400 Gi/L|Platelet counts were measured by blood draw.|Baseline; Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112, 116, 120, 124, 128, 132, and 136; and last visit/early withdrawal visit (up to Day 982)|Full Analysis Set (FAS): all participants with the exception of those who did not receive any dose of study medication and those with no valid measurements of platelet count on therapy. The number of participants analyzed varies by week because some participants prematurely withdrew and the timing of the measurement differs among participants.||percentage of participants|||Number
784871|NCT00828750|Primary|Number of Participants Experiencing an Adverse Event (AE) and/or Serious Adverse Event (SAE) Within the Indicated Category|An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medical product, whether or not related to the product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or its prolongation, results in disability/incapacity, is a congenital anomaly/birth defect, or is another event considered serious. A drug-related AE is any AE that was judged to have a relationship with the study medication by the investigator. The severity of an AE is based on the investigator's clinical judgment.|From Baseline (Day 1) to last dose of eltrombopag/early withdrawal visit (up to 981 days)|Safety Population (SP): all participants who received at least one dose of study medication||participants|||Number
784872|NCT00828841|Secondary|Overall Survival by Histology||Survival was measured from the date of randomization to date of death due to any cause, assessed up to 36 months. Subjects who were alive at the date of last contact were censored at the date of last contact.|Subjects were stratified by histology prior to randomization to a treatment arm.||Months||95% Confidence Interval|Median
784873|NCT00828841|Secondary|1-year Survival by Treatment Arm||Survival was measured from the date of randomization to date of death due to any cause, assessed up to 36 months. Subjects who were alive at the date of last contact were censored at the date of last contact.|||percentage of participants||95% Confidence Interval|Number
784874|NCT00828841|Primary|Overall Survival by Treatment Arm||Survival was measured from the date of randomization to date of death due to any cause, assessed up to 36 months. Subjects who were alive at the date of last contact were censored at the date of last contact.|Two subjects in Arm A were censored due to negative event intervals.||Months||95% Confidence Interval|Median
784875|NCT00833755|Primary|Change in Duration of Supra-threshold Pain Tolerance|"Using QST, we detected the duration (seconds) of tolerance to supra-threshold heat pain stimulation. In this test, subjects were asked to tolerate, as long as he or she could, heat stimulation preset at 47°C for a maximum of 60 seconds. They were given the computer mouse to stop the test if they reached their limit before 60 seconds. If they stopped the test before the 60 seconds, the time that they stopped it was recorded.
This test was repeated 3 times and an average duration was calculated. The duration could range from a minimum of 0 seconds to a maximum of 60 seconds."|Baseline at visit 1, post inufsion at visit 1, and at visit 2 which was 1 week after visit 1|Only subjects who experienced pain relief after the infusion were scheduled for visit 2. This is why the overall # of participants analyzed differs from the # of baseline participants.||seconds||Standard Deviation|Mean
784876|NCT00833755|Primary|Change in Temperature of Pain Tolerance|"Using QST, we measured the change in pain tolerance which was the maximum thermal stimulation intensity (in °C) tolerable. In this test, the subject was instructed to press the computer mouse to stop stimulation when the thermode reached the maximal tolerable temperature.
This test was repeated 3 times and an average temperature was calculated. The temperatures could range from a minimum of 0°C to 53°C."|Baseline at visit 1, post inufsion at visit 1, and at visit 2 which was 1 week after visit 1|Only subjects who experienced pain relief after the infusion were scheduled for visit 2. This is why the overall # of participants analyzed differs from the # of baseline participants.||Degrees Celsius||Standard Deviation|Mean
784877|NCT00833755|Primary|Change in Temperature of Pain Threshold|"We measured the change in pain threshold using Quantitative Sensory Testing (QST). QST refers to a set of quantitative testing of individual responses to mechanical, thermal, and/or electrical stimulation. In this study, pain threshold was the thermal stimulation intensity (in°C) first perceived as painful. To measure this, a contact thermode was attached onto the dorsal surface of the forearm. By pressing a computer mouse button, each subject was able to stop stimulation when they first perceived a painful stimulation from the thermode as the temperature increased 1°C/s.
This test was repeated 3 times and an average temperature was calculated. The temperatures could range from a minimum of 0°C to 53°C."|Baseline at visit 1, post inufsion at visit 1, and at visit 2 which was 1 week after visit 1|Only subjects who experienced pain relief after the infusion were scheduled for visit 2. This is why the overall # of participants analyzed differs from the # of baseline participants.||Degrees Celsius||Standard Deviation|Mean
784878|NCT00833781|Secondary|IL2 and IFN Gamma Production||Baseline to week 14|Results from these assays were too variable to be interpretable.|||||
784879|NCT00833781|Primary|Change From Baseline to Week 14 in ELISPOT Response to Gag and Nef|Immunogenicity was measure by interferon gamma enzyme-linked immunospot (ELISPOT) assay. The number of spot forming cells per million PBMC was determined at each time point. The fold ratio represents week 14 value divided by value at baseline.|Baseline and 14 weeks|||fold ratio||Full Range|Median
784880|NCT00833781|Secondary|T Cell Proliferation||Baseline to week 14|||fold change||95% Confidence Interval|Mean
784881|NCT00833781|Primary|Safety of the DC Vaccine (as Measured by Frequency of Adverse Events)|Number of participants with grade 3 or 4 adverse events related to vaccination|After vaccination|||participants|||Number
784882|NCT00833794|Secondary|Discontinuation Due to Adverse Events|The number of patients who discontinued due to adverse events (AEs). An AE is defined as any untoward medical event that occurs during the course of a clinical investigation in which a patient is administered a pharmaceutical or other therapeutic product. Its occurrence does not necessarily imply a causal relationship with the treatment.|12 weeks|Full analysis population: all randomized patients who received at least one dose of the randomized study medication regardless of the status of the post-dosing assessment.||participants|||Number
784883|NCT00833794|Secondary|Discontinuation Due to Lack of Efficacy|The number of patients who discontinued due to lack of efficacy was reported.|12 weeks|Full analysis population: all randomized patients who received at least one dose of the randomized study medication regardless of the status of the post-dosing assessment.||participants|||Number
784884|NCT00833794|Secondary|Time to Response|Response was defined as a decrease of ≥1 point in an 11-point PINRS (11-point pain intensity numerical rating scale ranging from 0: no pain to 10: worst possible pain) from baseline to the last visit. The time to response was estimated using Kaplan-Meier analysis and a 95% CI for the median time was calculated.|12 weeks|Full analysis population: all randomized patients who received at least one dose of the randomized study medication regardless of the status of the post-dosing assessment.||days||95% Confidence Interval|Median
784885|NCT00833794|Secondary|Physician Global Impression of Change at the End of the Study (Week 12 or Time of Discontinuation)|This assessment of overall impression of study drug is made using a 7-point categorical scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse)|week 12|Full analysis population: all randomized patients who received at least one dose of the randomized study medication regardless of the status of the post-dosing assessment.||participants|||Number
784886|NCT00833794|Secondary|Patient Global Impression of Change at the End of the Study (Week 12 or Time of Discontinuation)|This assessment of overall status integrates the effect of the treatment on pain, side effects, and the patient's expectation of pain relief. It is made using a 7-point categorical scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse)|12 weeks|Full analysis population: all randomized patients who received at least one dose of the randomized study medication regardless of the status of the post-dosing assessment.||participants|||Number
784887|NCT00833794|Secondary|WOMAC Physical Function Subscale Score at the End of the Study (Week 12 or Time of Discontinuation)|Mean WOMAC Physical Function Subscale score at week 12. The WOMAC scale is a 24-item questionnaire divided in 3 subscales, using a 5-point Likert-scale ranging from no difficulty to extreme difficulty (0-none; 1-slight; 2-moderate; 3-severe; 4-extreme). The WOMAC Physical Function subscale results from the sum of 17 physical function questions and the maximum possible score is 68.|12 weeks|Full analysis population: all randomized patients who received at least one dose of the randomized study medication regardless of the status of the post-dosing assessment.||Points on a scale||Standard Deviation|Mean
784888|NCT00833794|Secondary|WOMAC Pain Subscale Score at the End of the Study (Week 12 or Time of Discontinuation)|Mean WOMAC Pain Subscale score at week 12. The WOMAC scale is a 24-item questionnaire divided in 3 subscales, using a 5-point Likert-scale ranging from no difficulty to extreme difficulty (0-none; 1-slight; 2-moderate; 3-severe; 4-extreme). The WOMAC pain subscale results from the sum of 5 pain questions. The maximum total score is 20.|12 weeks|Full analysis population: all randomized patients who received at least one dose of the randomized study medication regardless of the status of the post-dosing assessment.||Points on a scale||Standard Deviation|Mean
784889|NCT00833794|Secondary|Pain Intensity Score Stratified by Dose, at the End of the Study (Week 12 or Time of Discontinuation)|Pain Intensity Score (an 11-point pain intensity numerical rating scale ranging from 0: no pain to 10: worst possible pain) was stratified by final dose level, at week 12 or time of discontinuation. The final optimum dose level based upon efficacy and tolerability was kept for the entire study. The mean score was calculated.|12 weeks|Full analysis population: all randomized patients who received at least one dose of the randomized study medication regardless of the status of the post-dosing assessment.||Points on a scale||Standard Deviation|Mean
784890|NCT00833794|Secondary|Pain Intensity Score (11-point PINRS) After 6 Weeks of Maintenance Treatment|The Pain Intensity Score is an 11-point pain intensity numerical rating scale ranging from 0: no pain to 10: worst possible pain|6 weeks|Full analysis population: all randomized patients who received at least one dose of the randomized study medication regardless of the status of the post-dosing assessment.||Points on a scale||Standard Deviation|Mean
784891|NCT00833794|Primary|Pain Intensity Score as Measured by the 11-point Pain Intensity-Numerical Rating Scale Score at the End of the Study (Week 12 or Time of Discontinuation)|The Pain Intensity Score is an 11-point pain intensity numerical rating scale ranging from 0: no pain to 10: worst possible pain. The mean score at the end of the study (week 12 or time of discontinuation) was calculated.|12 weeks|Full analysis population: all randomized patients who received at least one dose of the randomized study medication regardless of the status of the post-dosing assessment.||Points on a scale||Standard Deviation|Mean
784892|NCT00833833|Primary|Phase 2: Percentage of Participants With Progression-Free Survival (PFS) Events as of the 01 April 2011 Cut-off|"Percentage of participants with the progression-free survival events: disease progression and death. Disease progression was assessed by the Independent Response Adjudication Committee (IRAC).
Data collection is ongoing and future data results will be included as available."|up to 67 weeks|"Intent to treat population.
Data collection is ongoing and future data results will be included as available."||percentage of participants|||Number
784893|NCT00833833|Secondary|Phase 2: Kaplan-Meier Estimates of Overall Survival as of the 01 April 2011 Cut-off|"Overall survival was defined as the time between randomization and death. Participants who die, regardless of the cause of the death, were considered to have had an event. All participants who were lost to follow-up prior to the end of the trial or who were withdrawn from the trial were censored at the time of last contact. Participants who were still being treated were censored at the last available date the subject was known to be alive, or clinical cut-off date if it was earlier.
Data collection is ongoing and future data results will be included as available."|up to 70 weeks|"ITT population.
Data collection is ongoing and future data results will be included as available."||weeks||95% Confidence Interval|Median
784894|NCT00833833|Secondary|Phase 2: Time to Response as of the 01 April 2011 Cut-off|"Time to myeloma response is defined as the time from randomization to the time the response criteria for complete response (CR) or partial response (PR) are first met.
Response was assessed by the Independent Response Adjudication Committee (IRAC) using European Group for Blood and Bone Marrow Transplant (EBMT) criteria as described previously.
Data collection is ongoing and future data results will be included as available."|up to 70 weeks|"Responders (participants achieving CR or PR) from ITT population.
Data collection is ongoing and future data results will be included as available."||weeks||Full Range|Median
784895|NCT00833833|Secondary|Phase 2: Kaplan-Meier Estimates of Duration of Response as of the 01 April 2011 Cut-off|"Duration of myeloma response is defined as the time from when the response criteria are first met for partial response (PR) or better, until the first date the response criteria are met for progressive disease (PD) or until the participant dies from any cause, whichever occurs first. Duration of response for participants last known to be alive with no progression after a complete response (CR) or PR was censored at the date of last adequate response assessment. Participants with confirmed responses that occur after receiving any other anti-myeloma therapy (except for adding dexamethasone to the pomalidomide treatment arm), including radiation therapy initiated after baseline, was censored at the last adequate assessment prior to the initiation of such treatment.
Response was assessed by the Independent Response Adjudication Committee (IRAC) using European Group for Blood and Bone Marrow Transplant (EBMT) criteria as described in the previous outcome."|up to 70 weeks|"Responders (participants with a complete response or partial response) from the ITT population.
Data collection is ongoing and future data results will be included as available."||weeks||95% Confidence Interval|Median
784896|NCT00833833|Secondary|Phase 2: Summary of Best Myeloma Response As Assessed by Independent Response Adjudication Committee (IRAC) Using European Group for Blood and Bone Marrow Transplant (EBMT) Criteria as of the 01 April 2011 Cut-off|"IRAC used EBMT criteria to assess myeloma response:
Complete Response (CR)-absence of serum and urine monoclonal paraprotein for 6 weeks, plus no increase in size or number of lytic bone lesions, plus other factors)
Partial Response (PR)-not all CR criteria, plus >=50% reduction in serum monoclonal paraprotein plus others
Minimal Response (MR)- 25-49% reduction in serum monoclonal paraprotein plus others
Stable Disease (SD)- not MR or progressive disease (PD)
Progressive Disease (PD)- reappearance of monoclonal paraprotein, lytic bone lesions, other
Not Evaluable (NE).
Data collection is ongoing and future data results will be included as available."|up to 70 weeks|"Intent to treat population.
Data collection is ongoing and future data results will be included as available."||percentage of participants|||Number
784897|NCT00833833|Secondary|Phase 2: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) as of the 01 April 2011 Cut-off|"Relation to study drug was assessed by the Investigator as either suspected or not suspected. Counts represent the suspected relationship. Severity was assessed using National Cancer Institute Common Toxicity Terminology Criteria for Adverse Events version 3.0 (NCI CTCAE v3.0): 1= Mild 2= Moderate 3= Severe 4= Life-threatening and 5= Death related to AE. Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above.
Data collection is ongoing and future data results will be included as available."|Up to week 70|"Safety population.
Data collection is ongoing and future data results will be included as available."||percentage of participants|||Number
784909|NCT00833898|Secondary|Plasma Inflammatory Marker Interleukin 6 (IL-6)|Inflammatory markers increase in association with stress. IL-6 is an inflammatory marker that will be assessed using high sensitivity IL-6 assays.|Baseline (prior to transplant) and 3 post transplant|Caregiver Control group missing responses (n = 11). Caregiver Intervention group: missing responses (n = 4).||ln(pg/mL)||95% Confidence Interval|Mean
784910|NCT00833898|Secondary|Plasma Inflammatory Marker Interleukin 1 Beta (IL-1 Beta)|Inflammatory markers increase in association with stress. IL-1 beta is an inflammatory marker that will be determined in plasma using multiplex array technology.|Baseline (prior to transplant) and 3 post transplant|Wilcoxon signed rank t-test||pg/mL||Standard Deviation|Median
785155|NCT00835211|Primary|AUCinf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUCinf|Blood samples collected over 12 hour period|AUC0-inf could not be estimated for one subject in the reference arm.||pg*h/mL||Standard Deviation|Mean
784898|NCT00833833|Secondary|Phase 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) While on Both Pomalidomide and Dexamethasone as of the 01 April 2011 Cut-off|"TEAEs that occurred during Phase 1 after dexamethasone was added to pomalidomide treatment.
Relation to study drug was assessed by the Investigator as either suspected or not suspected. Counts represent the suspected relationship. Severity was assessed using National Cancer Institute Common Toxicity Terminology Criteria for Adverse Events version 3.0 (NCI CTCAE v3.0): 1= Mild 2= Moderate 3= Severe 4= Life-threatening and 5= Death related to AE. Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above.
Data collection is ongoing and future data results will be included as available."|Up to week 126|"Safety population.
Data collection is ongoing and future data results will be included as available."||percentage of participants|||Number
784899|NCT00833833|Secondary|Phase 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) While on Single-Agent Pomalidomide as of the 01 April 2011 Cut-off|"Relation to study drug was assessed by the Investigator as either suspected or not suspected. Counts represent the suspected relationship. Severity was assessed using National Cancer Institute Common Toxicity Terminology Criteria for Adverse Events version 3.0 (NCI CTCAE v3.0): 1= Mild 2= Moderate 3= Severe 4= Life-threatening and 5= Death related to AE. Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above.
Data collection is ongoing and future data results will be included as available."|Up to week 104|"Safety population.
Data collection is ongoing and future data results will be included as available."||percentage of participants|||Number
784900|NCT00833833|Primary|Phase 2: Kaplan-Meier Estimates of Progression-free Survival (PFS) as of the 01 April 2011 Cut-off|"Progression free survival (PFS) is the time from randomization to the first documentation of disease progression or death from any cause during study, whichever occurs earlier. Disease progression was assessed by the Independent Response Adjudication Committee (IRAC).
For the primary PFS analysis, participants who withdrew for any reason or received another antimyeloma therapy (except adding dexamethasone to the Phase 2: Pomalidomide arm) without documented PD (as determined by the IRAC review) were censored on the date of their last adequate response assessment, prior to receiving any other anti-myeloma therapy. Subjects who were still active at the time of the data cut-off date without PD (as determined by the IRAC) were censored on the date of their last adequate response assessment.
Data collection is ongoing and future data results will be included as available."|up to 67 weeks|"Intent to treat population.
Data collection is ongoing and future data results will be included as available."||weeks||95% Confidence Interval|Median
784901|NCT00833833|Primary|Phase 1: Participants With Dose-Limiting Toxicities (DLT) in Cycle 1|"The maximum tolerated dose was defined as the highest dose level at which no more than 1 of 6 participants experiences a DLT within the first 28-day cycle.
DLTs were defined as:
Grade 4 neutropenia or thrombocytopenia
Febrile neutropenia
Grade 3 or 4 nausea, vomiting or diarrhea despite optimal symptomatic treatment
Serum transaminase > 20 * upper limit of normal (ULN)
Serum transaminase > 5 * ULN for >= 7 days
Delay of the start of cycle 2 by >7 days due to pomalidomide-related adverse event"|Up to Day 28 (Cycle 1)|Safety population||participants|||Number
784906|NCT00833898|Secondary|Plasma Inflammatory Marker Tumor Necrosis Factor (TNF)|Inflammatory markers increase in association with stress. TNF is an inflammatory marker that will be determined in plasma using multiplex array technology.|Baseline (prior to transplant) and 3 post transplant|Wilcoxon signed rank t-test||pg/mL||Standard Deviation|Median
784907|NCT00833898|Secondary|Plasma Inflammatory Marker Interleukin 10 (IL-10)|Inflammatory markers increase in association with stress. IL-10 is an anti inflammatory marker that will be determined in plasma using multiplex array technology.|Baseline (prior to transplant) and 3 post transplant|Wilcoxon signed rank t-test||pg/mL||Standard Deviation|Median
784908|NCT00833898|Secondary|Plasma Inflammatory Marker Interleukin 4 (IL-4)|Inflammatory markers increase in association with stress. IL-4 is an anti inflammatory marker that will be determined in plasma using multiplex array technology.|Baseline (prior to transplant) and 3 post transplant|Wilcoxon signed rank t-test||pg/mL||Standard Deviation|Median
784951|NCT00834132|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)- Azithromycin in Plasma|Bioequivalence based on AUC0-t|Blood samples collected over 168 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
784911|NCT00833898|Secondary|Plasma C-reactive Protein (CRP)|Plasma c-reactive (CRP) is an acute phase reactant that has been found to be predictive of cardiovascular disease. Is is also an inflammatory marker that will be assessed using high sensitivity CRP assays.|Baseline (prior to transplant) and 3 post transplant|Caregiver Control group missing responses (n = 7). Caregiver Intervention group: missing responses (n = 6).||ln(mg/L)||95% Confidence Interval|Mean
784912|NCT00833898|Secondary|Host Defense Assessed by Natural Killer (NK) Cell Cytotoxicity|The activity of natural killer (NK) cells is modified by psychosocial and behavioral states (Cacioppo et al., 1998; Irwin et al., 1991; Kiecolt-Glaser et al., 1991; Kiecolt-Glaser, 1999; Kiecolt-Glaser, McGuire, Robles, et al., 2002a; Kiecolt-Glaser, McGuire, Robles, et al., 2002b). Natural cytotoxicity will be determined toward K562 target cell lines as previously described (Laudenslager et al., 1998; Scanlan, et al., 1995). Percent lysis at each effector to target ratio will be found from the median value of each triplicate determination and from which the percent lysis/NK + cell will be determined for 20% lysis (lytic units/NK+ cell).|Baseline (prior to transplant), 1 and 3 post transplant|Caregiver Control group missing responses (n = 8). Caregiver Intervention group: missing responses (n = 2).||ln(% Lysis/NK+ Cell)||95% Confidence Interval|Mean
784913|NCT00833898|Secondary|Area Under the Curve for Salivary DHEA (AUCd)|The AUCd will be determined between awaking, 30 minutes after awaking, prior to lunch, and 10 hours after awaking from saliva samples collected using a special filter collection device applied in this study. This area will be an estimate of total DHEA released during this time period.|Baseline (prior to transplant), 1 and 3 post transplant|Caregiver Control group missing responses (n = 16). Caregiver Intervention group: missing responses (n = 14).||ln[(nmol/L)*hour]||95% Confidence Interval|Mean
784914|NCT00833898|Secondary|Area Under the Curve for Salivary Cortisol (AUCc)|The AUCc will be determined between awaking, 30 minutes after awaking, prior to lunch, and 10 hours after awaking from saliva samples collected using a special filter collection device applied in this study. This area will be an estimate of total cortisol released during this time period.|Baseline (prior to transplant), 1 and 3 post transplant|Caregiver Control group missing responses (n = 16). Caregiver Intervention group: missing responses (n = 14).||ln[(nmol/L)*hour]||95% Confidence Interval|Mean
784915|NCT00833898|Secondary|The Slope of the Diurnal Decline (SlopeD) in Salivary Dehydroepiandrosterone (DHEA)|The SlopeD has been noted to be affected by affective disorders such as depression. From diurnal saliva collections at each phase we will fit curves between awake, before lunch, and +10 hours after awaking to characterize the diurnal change in salivary DHEA.|Baseline (prior to transplant), 1 and 3 post transplant|Caregiver Control group missing responses (n = 16). Caregiver Intervention group: missing responses (n = 15).||ln[(nmol/L)/hour]||95% Confidence Interval|Mean
784916|NCT00833898|Secondary|The Slope of the Diurnal Decline in Salivary Cortisol (SlopeC)|The SlopeC has been noted to be affected by stressful experiences. From diurnal saliva collections at each phase we will fit curves between awake, before lunch, and 10 hours after awaking to characterize the diurnal change in salivary cortisol (SlopeC).|Baseline (prior to transplant), 1 and 3 post transplant|Caregiver Control group missing responses (n = 12). Caregiver Intervention group: missing responses (n = 12).||ln[(nmol/L)/hour]||95% Confidence Interval|Mean
784917|NCT00833898|Secondary|Stress as Measured by the Impact of Events Scale (IES)|The Impact of Events Scale (IES), a widely accepted measure for evaluating intrusive thoughts regarding an event or situation. The scale consists of 15 items (7 measuring intrusive thoughts and 8 measuring avoidance) scored on a 5-point Likert Scale. Minimum score (best value)=0. Maximum score (worst value)=75. Scores over 20 indicate significant levels of PTS-like symptoms. The IES is anchored to the caregiving experience.|Baseline (prior to transplant), 1 and 3 post transplant|Caregiver Control group missing responses (n = 4). Caregiver Intervention group: missing responses (n = 2).||units on a scale||95% Confidence Interval|Mean
784918|NCT00833898|Secondary|Physical Component Summary Via the Short-Form 36-Item Health Survey Version 2.0 (SF-36P)|The Short-Form 36-Item Health Survey Version 2.0 (SF-36) is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; as well as the social functioning, vitality, and general health. Scores are based on a scale from 0 to 100, with higher scores defining more favorable health state.|Baseline (prior to transplant), 1 and 3 post transplant|Caregiver Control group missing responses (n = 4). Caregiver Intervention group: missing responses (n = 4).||units on a scale||95% Confidence Interval|Mean
784919|NCT00833898|Secondary|Mental Component Summary Via the Short-Form 36-Item Health Survey Version 2.0 (SF-36M)|The Short-Form 36-Item Health Survey Version 2.0 (SF-36) is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Role emotional, social functioning and mental health contribute to mental component; as well as the social functioning, vitality, and general health. Scores are based on a scale from 0 to 100, with higher scores defining more favorable health state.|Baseline (prior to transplant), 1 and 3 post transplant|Caregiver Control group missing responses (n = 4). Caregiver Intervention group: missing responses (n = 4).||units on a scale||95% Confidence Interval|Mean
784920|NCT00833898|Secondary|Sleep as Assessed by the Pittsburgh Sleep Quality Inventory (PSQI) Total Score|The Pittsburgh Sleep Quality Index (PSQI) is a self-rated scale to measure quality of sleep via questions regarding sleep latency, duration, efficiency, disturbances, use of sleep medication, and daytime dysfunction. Scores range from 0 to 21, where scores greater than 5 indicate poor sleep quality.|Baseline (prior to transplant), 1 and 3 post transplant|Caregiver Control group missing responses (n = 3). Caregiver Intervention group: missing responses (n = 1).||units on a scale||95% Confidence Interval|Mean
784921|NCT00833898|Secondary|Stress as Measured by Caregiver Burden Using the Caregiver Reaction Assessment (CRA)|The Caregiver Reaction Assessment (CRA) is a measure of caregiver burden. This instrument contains 24 items reflecting the total caregiver situation in the past month. The scale refers to the caregiver. Minimum score (best value)=5. Maximum score (worst value)=25. Higher values reflect the experience of a higher burden.|Baseline (prior to transplant), 1 and 3 post transplant|Caregiver Control group missing responses (n = 5). Caregiver Intervention group: missing responses (n = 1).||units on a scale||95% Confidence Interval|Mean
785156|NCT00835211|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 12 hour period|Data from all subjects who completed the study were included in the statistical analysis.||pg/mL||Standard Deviation|Mean
784922|NCT00833898|Secondary|Total Mood Disturbance (TMD) Score Using the Profile of Mood States (POMS)|POMS stands for the Profile of Mood States. The POMS consists of 65 adjectives rated by subjects on a 5-point scale and six factors that derive from this scale are: 1) tension-anxiety, 2) depression-dejection, 3) anger-hostility, 4) fatigue-inertia, 5) vigor-activity and 6) Confusion-bewilderment. A Total Mood Disturbance (TMD) can be calculated by adding the scores for Tension, Depression, Anger, Fatigue and Confusion and then subtracting the score for Vigour. The range for the Total Mood Disturbance (TMD) score is 0 – 200, with higher score indicating more mood disturbance.|Baseline (prior to transplant), 1 and 3 post transplant|Caregiver Control group missing responses (n = 4). Caregiver Intervention group: missing responses (n = 1).||units on a scale||95% Confidence Interval|Mean
784923|NCT00833898|Secondary|State Anxiety as Measured by the Spielberger State-Trait Anxiety Inventory (STAI)|The State and Trait Anxiety Inventory (STAI) is a validated self-reporting instrument used to assess anxiety in adults. The inventory consists of 2 scales, state anxiety, which evaluates how the subject feels currently (transient anxiety), and trait anxiety, which evaluates how the subject feels generally (general tendency towards anxiety). Each scale consists of 20 questions, and a higher score indicates greater anxiety. Scores range from 20 (no anxiety) to 80 (maximum anxiety).|Baseline (prior to transplant), 1 and 3 post transplant|Caregiver Control group missing responses (n = 3). Caregiver Intervention group: missing responses (n = 1).||units on a scale||95% Confidence Interval|Mean
784924|NCT00833898|Secondary|Depression Measured by the Center for Epidemiological Studies Depression Scale (CESD)|The Center for Epidemiological Studies Depression Scale (CES-D) is a self-report 20-item scale designed to measure current depressive symptoms. Scores range from 0-60, with a score at or above 16 reflecting significant depressive symptomatology.|Baseline (prior to transplant), 1 and 3 post transplant|Caregiver Control group missing responses (n = 5). Caregiver Intervention group: missing responses (n = 2).||units on a scale||95% Confidence Interval|Mean
784925|NCT00833898|Primary|Physiological - Cortisol Awakening Response (CAR)|Saliva will be collected using SPIT booklets containing four separate filter papers corresponding to collection times separated by waxed paper. Subjects will be asked to moisten a filter paper 1) immediately after waking, 2) 30 min later, 3) before lunch and 4) 10 hours after waking. They will be asked to collect these samples on three days typical for their schedules at each phase of the. They will indicate the time of each collection. Filters will dry in the booklet. Saliva samples will be aggregated across the three sampling days at each study phase to better reflect the typical pattern for each subject (see Smyth et al, 1997). The change from awakening to 30 minutes in cortisol (CAR) will be characterized by the change between waking and 30 min.|Baseline (prior to transplant), 1 and 3 post transplant|Caregiver Control group missing responses (n = 15). Caregiver Intervention group: missing responses (n = 15).||ln(nmol/L)||95% Confidence Interval|Mean
784926|NCT00833898|Primary|Behavioral - Stress Level as Measured by the Perceived Stress Scale (PSS)|The Perceived Stress Scale (PSS) measures the overall level of stress. This instrument contains 14 items accessing overall appraisals of stress in the past month. Minimum score (best value)=0. Maximum score (worst value)=56. A higher score indicates greater stress.|Baseline (prior to transplant), 1 and 3 post transplant|Caregiver Control group missing responses (n = 4). Caregiver Intervention group: missing responses (n = 2).||units on a scale||95% Confidence Interval|Mean
784927|NCT00833911|Primary|Number of Patients Having Experienced an Adverse Event During the 6-12 Month Open-Label Safety Participation|Spontaneous reports of adverse events were recorded for the entire study population, the 6-months safety population and the 12-months safety population|6 months and 12 months|"All patients having taken 1 dose of 300 mg Tramadol HCl OAD at a minimum are being assessed for adverse event occurence for up to 12 months.
6-months safety: patients who completed at least 175 days on treatment.
12-months safety: patients who completed at least 350 days on treatment."||participants|||Number
784928|NCT00833924|Primary|Patients With Device Failures|"Device success at 12-month is defined as:
Technical Success (successful access of the aneurysm site, deployment of the graft in the intended location, and patency of the graft at the time of deployment completion intra-operatively), and freedom from the following at 12 months: Type I or type III endoleaks requiring re-intervention, Aneurysm rupture or conversion to open surgical repair, and Aneurysm enlargement greater than 0.5 cm."|12-month|There were 5 patients died, and 2 patients withdrew.||participants|||Number
784929|NCT00833924|Primary|Patients With Major Adverse Events (MAE)|MAE is defined as any occurrence of all-cause death, Q-wave myocardial infarction (MI), renal failure requiring dialysis, paralysis, stroke, bowel ischemia, or re-intubation.|30-day|1 patient experienced a re-intubation, which was adjudicated by the CEC as not related to AAA repair (related to a pre-existing condition).||participants|||Number
784930|NCT00833937|Primary|AUC0-t - Area Under the Concentration-Time Curve From Time Zero to Time of Last Non-Zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
784931|NCT00833937|Primary|AUC0-Inf - Area Under the Concentration-Time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
784932|NCT00833937|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
784933|NCT00833976|Secondary|Tolerability of Omega-3 Fatty Acid Capsules (Lovaza)|At each of the visits, participants completed a questionnaire to determine tolerability of the omega-3 fatty acid capsules (Lovaza).|16 weeks|All participants who took at least one dose of the study medication were included in the analyzable population.||Participants|||Count of Participants
784934|NCT00833976|Secondary|Change in Total Cholesterol From Baseline to 16 Weeks||16 weeks|Although only 14 participants completed the triall, 16 were included in the analyzable population. The 2 participants who are analyzable but not completers were lost to follow-up. They were included in the analysis since they still had 2 measurements time points. These 16 participants all had adherence values, as determined by pill count, of ≥75%||mg/dL||Standard Deviation|Mean
784952|NCT00834132|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Azithromycin in Plasma|Bioequivalence based on AUC0-inf|Blood samples collected over 168 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
784935|NCT00833976|Primary|Change in Triglycerides From Baseline to 16 Weeks||16 weeks|Although only 14 participants completed the triall, 16 were included in the analyzable population. The 2 participants who are analyzable but not completers were lost to follow-up. They were included in the analysis since they still had 2 measurements time points. These 16 participants all had adherence values, as determined by pill count, of ≥75%||mg/dL||Standard Deviation|Mean
784936|NCT00834041|Primary|Apparent Plasma Clearance (CL/F) at Day 8 in 6-11 and 12-17 Year Old Patients|Blood samples (1 mL) for pharmacokinetic (PK) evaluation were drawn pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 10, and 24 hours following administration of aliskiren on Day 1 and Day 8. The pre-dose PK evaluations were collected in a fasted state (7-12 hours without food or beverage except water). PK parameters were calculated from plasma concentration-time data and actual recorded sampling times for each patient, using non-compartmental methods with the software program WinNonlin Pro v5.2.|Day 8|Pharmacokinetic population: All patients who had evaluable aliskiren concentration data.||mL/h/kg||Standard Deviation|Mean
784937|NCT00834041|Primary|Area Under the Plasma Concentration-time Curve (AUC0-τ) in One Dosing Interval (24 h) at Day 1 and Day 8 in 6-11 and 12-17 Year Old Patients|Blood samples (1 mL) for pharmacokinetic (PK) evaluation were drawn pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 10, and 24 hours following administration of aliskiren on Day 1 and Day 8. The pre-dose PK evaluations were collected in a fasted state (7-12 hours without food or beverage except water). PK parameters were calculated from plasma concentration-time data and actual recorded sampling times for each patient, using non-compartmental methods with the software program WinNonlin Pro v5.2.|Day 1 and Day 8|Pharmacokinetic population: All patients who had evaluable aliskiren concentration data.||h*ng/mL||Standard Deviation|Mean
784938|NCT00834041|Secondary|Change in Mean Sitting Systolic and Diastolic Blood Pressure (msSBP and msDBP) From Baseline to the End of Treatment (Day 9) in 6-11 and 12-17 Year Old Patients|Blood pressure (BP) measurements were made with a mercury sphygmomanometer or an automated blood pressure measuring device. Sitting BP was measured 3 times at 2-3 minute intervals after the patient had been sitting for 5 minutes. Means of the 3 measurements were calculated. A negative change in BP indicates lowered BP.|Baseline to end of treatment (Day 9)|Full Analysis Set (FAS): All randomized patients, excluding mis-randomized patients.||mmHg||Standard Deviation|Mean
784939|NCT00834041|Secondary|Change in Plasma Renin Activity From Baseline on Day 1, Day 8, and Day 9|Blood samples (2 mL) for pharmacodynamics evaluation of plasma renin activity were drawn pre-dose and at 2 and 10 hours following the dose of study medication on Day 1 and at pre-dose and at 2, 10, and 24 hours post-dose on Day 8-9.|Baseline to 2 and 10 hours post-dose on Day 1; pre-dose, 2, 10, and 24 hours post-dose on Day 8-9|Full Analysis Set (FAS): All randomized patients, excluding mis-randomized patients. Data was not available for all patients at all time points. For each time point, n = the number of subjects for whom data was available for each treatment group.||ng/mL/h||Standard Deviation|Mean
784940|NCT00834041|Primary|Maximum Plasma Concentration (Cmax) at Day 1 and Day 8 in 6-11 and 12-17 Year Old Patients|Blood samples (1 mL) for pharmacokinetic (PK) evaluation were drawn pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 10, and 24 hours following administration of aliskiren on Day 1 and Day 8. The pre-dose PK evaluations were collected in a fasted state (7-12 hours without food or beverage except water). PK parameters were calculated from plasma concentration-time data and actual recorded sampling times for each patient, using non-compartmental methods with the software program WinNonlin Pro v5.2.|Day 1 and Day 8|Pharmacokinetic population: All patients who had evaluable aliskiren concentration data.||ng/ml||Standard Deviation|Mean
784941|NCT00834067|Secondary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) of Moexiprilat.|Informational comparison of AUC0-inf values for the metabolite Moexiprilat.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
784942|NCT00834067|Secondary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) of Moexiprilat.|Informational comparison of AUC0-t values for the metabolite Moexiprilat.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
784943|NCT00834067|Secondary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma) of Moexiprilat.|Informational comparison of Cmax values for the metabolite Moexiprilat.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
784944|NCT00834067|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) of Hydrochlorothiazide.|Bioequivalence based on AUC0-inf.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
784945|NCT00834067|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) of Hydrochlorothiazide.|Bioequivalence based on AUC0-t.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
784946|NCT00834067|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma) of Hydrochlorothiazide.|Bioequivalence based on Cmax.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
784947|NCT00834067|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) of Moexipril.|Bioequivalence based on AUC0-inf.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
784948|NCT00834067|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) of Moexipril.|Bioequivalence based on AUC0-t.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
784949|NCT00834067|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma) of Moexipril.|Bioequivalence based on Cmax.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
784950|NCT00834080|Primary|Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study.|A TEAE is any adverse event (AE), whether or not considered drug-related, that develops or worsens in severity after study drug administration begins (ie, from the first administration through the end of the follow-up period).|2 years (Baseline to end of study)|The Safety Population, defined as all subjects who received at least 1 dose (injection) of study drug, was used for presentation and analysis of both safety and efficacy data.||participants|||Number
784954|NCT00834171|Primary|Mean Elevated Intraocular Pressure (IOP) During Treatment|Mean elevated IOP during treatment. IOP is a measurement of the fluid pressure inside the eye. IOP was recorded any time an elevation of IOP (increase of 5 mmHg or more) occurred while using study treatment. The median duration of treatment at the time of observed IOP elevation was 55 days.|55 days|Intent to treat, which included all patients in the study.||Millimeters of mercury (mmHg)||Standard Deviation|Mean
784955|NCT00834197|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 120 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
784956|NCT00834197|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 120 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
784957|NCT00834197|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Cmax.|Blood samples collected over a 120 hour period.|All participants that completed the study had their samples analyzed.||pg/mL||Standard Deviation|Mean
784958|NCT00834210|Secondary|Change From Baseline in Non-Inflammatory Lesion Counts (Open and Closed Comedones) at Week 12|"Change from baseline in non-inflammatory lesion counts(open/closed comedones) at week 12. Comedones are small bumps on the skin (lesions) caused by acne and found at the opening of a skin pore. Open comedones (also known as blackheads) have a microscopic opening to the skin surface, while closed comedones (also known as whiteheads or pimples) lack the opening to the skin. A negative number change from baseline indicates a reduction in lesion counts (improvement)."|Baseline, Week 12|Intent-to-treat (ITT), which included all patients who started the study (randomized).||Number of lesions||Standard Deviation|Mean
784959|NCT00834210|Secondary|Change From Baseline in Overall Disease Severity at Week 12|Change from baseline in overall disease severity at week 12. The overall disease severity was evaluated by the investigator using a 7-point scale to rate the overall acne severity (lesions, inflammation, facial redness and skin condition), where 0=no acne lesions and 6=most severe acne. A negative number change from baseline indicates a reduction in overall acne disease severity (improvement).|Baseline, Week 12|Intent-to-treat (ITT), which included all patients who started the study (randomized).||Scores on a scale||Standard Deviation|Mean
784960|NCT00834210|Secondary|Change From Baseline in Investigator Global Assessment at Week 12|Change from baseline in the Investigator Global Assessment (IGA) at week 12. The IGA is a 5-point scale used by the investigator to assess overall acne severity, where 0 equals clear skin (no evidence of acne) and 4 equals severe acne. A negative number change from baseline indicates a reduction in acne severity (improvement).|Baseline, Week 12|Intent-to-treat (ITT), which included all patients who started the study (randomized)||Scores on a scale||Standard Deviation|Mean
784961|NCT00834210|Primary|Change From Baseline in Inflammatory Lesion Counts (Papules,Pustules, and Nodules) at Week 12|Change from baseline in inflammatory lesion count (papules, pustules and nodules) at week 12. Papules and nodules are round, solid elevations of the skin with no visible fluid; papules are smaller (less than 5 or 10 millimeters in width and depth) and nodules are larger (greater than 5 or 10 millimeters in width and depth). Pustules are small elevations of the skin containing cloudy material. A negative number change from baseline indicates a reduction in lesion counts (improvement).|Baseline, Week 12|Intent-to-treat (ITT), which included all patients who started the study (randomized).||Number of Lesions||Standard Deviation|Mean
784962|NCT00834236|Primary|Number of Participants With Accurate Diagnosis for Gastric Cancer|Normal subject group: number of the subjects with normal alpha 1-antitrypsin level in gastric juice Gastric cancer group: number of the subjects with elevated alpha 1-antitrypsin level in gastric juice|2 months|||participants|||Number
784963|NCT00834249|Secondary|AUC0-t - O-desmethylvenlafaxine in Plasma|Informational Purposes Only|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
784964|NCT00834249|Secondary|AUC0-inf - O-desmethylvenlafazine in Plasma|Informational Purposes Only|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
784965|NCT00834249|Secondary|Cmax - O-Desmethylvenlafaxine in Plasma|Informational Purposes Only|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
784966|NCT00834249|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Venlafaxine in Plasma|Bioequivalence based on AUC0-t|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
784967|NCT00834249|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Venlafaxine in Plasma|Bioequivalence based on AUC0-inf|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
784968|NCT00834249|Primary|Cmax - Maximum Observed Concentration - Venlafaxine in Plasma|Bioequivalence based on Cmax|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
784969|NCT00834275|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
784970|NCT00834275|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
784971|NCT00834275|Primary|Cmax (Maximum Observed Concentration)|Bioequivalence based on Cmax.|Blood samples collected over a 12 hour period|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
784972|NCT00834288|Secondary|Plateau Time (T75%Cmax)|Time over which plasma concentrations were above 75% Cmax on day 5. 24h = 24 hours.|24 hours (day 5)|||hours||Standard Deviation|Mean
784973|NCT00834288|Secondary|Half-value Duration (HVD)|Time over which plasma concentrations were above one half Cmax on day 5. 24h = 24 hours.|24 hours (day 5)|||hours||Standard Deviation|Mean
784974|NCT00834288|Secondary|Percentage Swing|"Percentage swing is a pharmacokinetic parameter recommended by the FDA for submission and is calculated as follows:((Cmax,ss - Cmin,ss)/Cmin,ss)*100. It was calculated over 24 hours on day 5.
Where:
Cmax,ss = Maximum concentration at steady state; Cmin,ss = Minimum concentration at steady state."|24 hours (day 5)|||percentage of fluctuation||Standard Deviation|Mean
784975|NCT00834288|Secondary|Percentage Peak-trough Fluctuation (% PTF)|"Percentage peak-trough fluctuation over 24 hours (24h) at steady state on day 5.
Percent peak-to-trough fluctuation is calculated as (Cmax - Cmin)/Cav*100, where Cmax is the maximum observed concentration, Cmin is the minimum observed concentration and Cav is the average concentration over 24 hours (where Cav = AUCss/24)."|24 hours (day 5)|||percentage of fluctuation||Standard Deviation|Mean
784976|NCT00834288|Secondary|Time to Peak Exposure (Tmax)|Time to peak exposure over 24 hours (24h) at steady state on day 5.|24 hours (day 5)|||hours||Full Range|Median
784977|NCT00834288|Secondary|Minimum Plasma Concentration at Steady State(Cmin,ss)|Minimum plasma concentration over 24 hours (24h) at steady state on day 5. ss = steady state.|24 hours (day 5)|||ng/mL||Standard Deviation|Mean
784978|NCT00834288|Secondary|Maximum Plasma Concentration at Steady State(Cmax,ss)|Maximum plasma concentration over 24 hours (24h) at steady state, on day 5. ss = steady state.|24 hours (day 5)|||ng/mL||Standard Deviation|Mean
784979|NCT00834288|Primary|Area Under the Plasma Concentration Versus Time Data Pairs at Steady State (AUCss)|"Area under the plasma concentration versus time data pairs over 24 hours (24h) at steady state, on day 5.
ss = steady state. AUCss is also known as AUCtau."|24 hours (day 5)|||ng*h/mL||Standard Deviation|Mean
784980|NCT00834340|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration|Bioequivalence based on AUC0-t|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
784981|NCT00834340|Primary|AUCinf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUCinf|Blood samples collected over 24 hour period|The parameter of AUCinf could not be estimated for one subject.||ng*h/mL||Standard Deviation|Mean
784982|NCT00834340|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
784983|NCT00834366|Secondary|t1/2|Apparent terminal elimination half-life|48 hours|||hours||Standard Deviation|Mean
784984|NCT00834366|Primary|Cmax|Maximum plasma concentration|48 hours|||ng/mL||Standard Deviation|Mean
784985|NCT00834366|Primary|AUC(0-Inf)|Area under plasma concentration versus time curve extrapolated to infinity. Unit is ng.h/mL. h=hour.|48 hours|||ng.h/mL||Standard Deviation|Mean
784986|NCT00834366|Secondary|Tmax|Time to the maximum concentration|48 hours|||hours||Full Range|Median
784987|NCT00834366|Primary|AUC(0-t)|Area under plasma concentration versus time curve to the last measurable concentration. Unit is ng.h/mL. h=hours.|48 hours|||ng.h/mL||Standard Deviation|Mean
784988|NCT00834405|Primary|AUC0-72 - Area Under the Concentration-time Curve From Time Zero to 72 Hours Post-dose (Per Participant) - Metabolite A77 1726|Bioequivalence based on AUC0-72|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
784989|NCT00834405|Primary|Cmax - Maximum Observed Concentration - Metabolite A77 1726 in Plasma|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
784990|NCT00834418|Primary|AUC0-72 - Area Under the Concentration-time Curve From Time Zero to 72 Hours Post-dose - Metabolite A77 1726|Bioequivalence based on AUC0-72|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
784991|NCT00834418|Primary|Cmax - Maximum Observed Concentration - Metabolite A77 1726 in Plasma|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
784992|NCT00834431|Primary|AUC0-inf = Area Under the Concentration-time Curve From Time Zero to Infinity.|Bioequivalence based on AUC0-inf.|Blood samples collected over a 16 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
784993|NCT00834431|Primary|AUC0-t = Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration (Per Participant)|Bioequivalence based on AUC0-t.|Blood samples collected over a 16 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
784994|NCT00834431|Primary|Cmax = Maximum Observed Concentration.|Bioequivalence based on Cmax.|Blood samples collected over a 16 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
784995|NCT00834444|Primary|AUC0-inf = Area Under the Concentration-time Curve From Time Zero to Infinity.|Bioequivalence based on AUC0-inf.|Blood samples collected over a 16 hour period.|All participants that completed the study had their samples analyzed. Data from one withdrawn subject was also included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
784996|NCT00834444|Primary|AUC0-t = Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration (Per Participant)|Bioequivalence based on AUC0-t.|Blood samples collected over a 16 hour period.|All participants that completed the study had their samples analyzed. Data from one withdrawn subject was also included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
784997|NCT00834444|Primary|Cmax = Maximum Observed Concentration.|Bioequivalence based on Cmax.|Blood samples collected over a 16 hour period.|All participants that completed the study had their samples analyzed. Data from one withdrawn subject was also included in the statistical analysis.||ng/mL||Standard Deviation|Mean
784998|NCT00834483|Secondary|Visual Analog Score, Cosmesis|"Overall cosemesis was graded by patient and surgeon. This is based on a 1-6 scale, with a 6 being a perfect score based upon satisfaction with the wound cosmesis.
1 is an unacceptable or poor perspective in regards to wound cosmesis."|6 months|Power analysis described above||units on a scale (1 is a low score)||Full Range|Mean
784999|NCT00834483|Secondary|Cost-analysis|Cost savings included the material costs and then we factored in the time savings in the OR. The OR time was based upon the average cost per minute to work in one of our ORs|1 year|Power analysis was performed as above.||Dollars||Standard Deviation|Mean
785000|NCT00834483|Primary|Closure Time|We performed a prospective, randomized clinical trial to evaluate the efficacy of using a bidirectional barbed suture compared with traditional sutures in the deep closure of primary total hip (25) and knee (35) arthroplasties. Complications, time to closure, and length of surgery were evaluated.|6 months|A power analysis was performed based on mean closure times by the 2 surgeons and determined that a sample size of 23 patients in each group would provide 90% power to detect a 50% difference in closure time. To account for patients being lost to FU, we enrolled 29 to the traditional closure group and 31 to the barbed closure group||Average time in minutes||Full Range|Mean
785001|NCT00834522|Primary|AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)]|Bioequivalence based on AUC0-t|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
785002|NCT00834522|Primary|AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)]|Bioequivalence based on AUC0-inf|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
785003|NCT00834522|Primary|Cmax (Maximum Observed Concentration)|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
785004|NCT00834535|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 14 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
785005|NCT00834535|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 14 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
785006|NCT00834535|Primary|Cmax (Maximum Observed Concentration)|Bioequivalence based on Cmax.|Blood samples collected over a 14 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
785007|NCT00834561|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 120 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
785008|NCT00834561|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 120 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
785009|NCT00834561|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 120 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
785010|NCT00834574|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 14 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
785011|NCT00834574|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 14 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
785012|NCT00834574|Primary|Cmax (Maximum Observed Concentration)|Bioequivalence based on Cmax.|Blood samples collected over a 14 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
785013|NCT00834587|Primary|AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Metformin|Bioequivalence based on AUC0-t|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
785014|NCT00834587|Primary|AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Metformin|Bioequivalence based on AUC0-inf|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis. Data from one completed subject could not be used to estimate AUC0-inf.||ng*h/mL||Standard Deviation|Mean
785015|NCT00834587|Primary|Cmax (Maximum Observed Concentration) - Metformin in Plasma|Bioequivalence based on Cmax|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
785016|NCT00834587|Primary|AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)] - Glipizide|Bioequivalence based on AUC0-t|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
785017|NCT00834587|Primary|AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Glipizide|Bioequivalence based on AUC0-inf|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
785018|NCT00834587|Primary|Cmax (Maximum Observed Concentration) - Glipizide in Plasma|Bioequivalence based on Cmax|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
785019|NCT00834613|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
785020|NCT00834613|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
785021|NCT00834613|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Cmax.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
785022|NCT00834626|Secondary|Percentage of Participants Achieving Remission in Hypertension|Percentage of participants achieving remission in hypertension, that is blood pressure less than 130/80 mm Hg without any anti-hypertensive medication|1 year|||Percentage of Participants|||Number
785029|NCT00834678|Primary|Progression-free Survival at 6 Months and 12 Months (Phase II)|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Up to two years|||months||95% Confidence Interval|Mean
785030|NCT00834678|Secondary|Relationship of EGFR Expression or Amplification, Basal-like Tumors, and DNA Damage-repair Checkpoint Activation With ORR, CBR, DR, and OS||up to two years|Correlative studies to assess EGFR expression and gene amplification, were planned, but not performed because of early trial termination.|||||
785031|NCT00834678|Secondary|Overall Survival (OS) Rate||from time of study enrollment until death, for up to 2 years|||months||95% Confidence Interval|Median
785032|NCT00834678|Secondary|Duration of Response (DR)||Up to two years|||months to progression||95% Confidence Interval|Median
785033|NCT00834678|Secondary|Clinical Benefit Rate (CBR)||Up to two years||||||
785034|NCT00834678|Secondary|Objective Response Rate (ORR)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to two years|||patients|||Number
785035|NCT00834678|Primary|Dose-limiting Toxicity (Phase I)||Up to two years|||patients|||Number
785036|NCT00834678|Primary|Maximum-tolerated Dose of Erlotinib Hydrochloride (Phase I)|28 day cycle included intravenous erlotinib on days 15-21.|Up to two years|||mg|||Number
785037|NCT00834678|Primary|Maximum-tolerated Dose of Bendamustine Hydrochloride (Phase I)|28 day cycle included intravenous bendamustine on days 1 and 2.|Up to two years|||mg/m^2|||Number
785038|NCT00834717|Primary|AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)]|Bioequivalence based on AUC0-t|Bl;ood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
785039|NCT00834717|Primary|Auc0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)]|Bioequivalence based on AUC0-inf|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
785040|NCT00834717|Primary|Cmax (Maximum Observed Concentration)|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
785041|NCT00834743|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
785042|NCT00834743|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
785043|NCT00834743|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Cmax.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
785044|NCT00834756|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of the Last Non-zero Concentration (Per Participant) - Azithromycin in Plasma|Bioequivalence based on AUC0-t|Blood samples collected over 168 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
785045|NCT00834756|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Azithromycin in Plasma|Bioequivalence based on AUC0-inf|Blood samples collected over 168 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
785046|NCT00834756|Primary|Cmax - Maximum Observed Concentration - Azithromycin in Plasma|Bioequivalence based on Cmax|Blood samples collected over 168 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
785047|NCT00834795|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Carvedilol in Plasma|Bioequivalence based on AUC0-t|Blood samples collected over 60 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
785048|NCT00834795|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Carvedilol in Plasma|Bioequivalence based on AUC0-inf|Blood samples collected over 60 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
785049|NCT00834795|Primary|Cmax - Maximum Observed Concentration - Carvedilol in Plasma|Bioequivalence based on Cmax|Blood samples collected over 60 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
785050|NCT00834808|Secondary|t1/2|Apparent terminal elimination half-life|48 hours|||hours||Standard Deviation|Mean
785051|NCT00834808|Secondary|Tmax|Time to maximum plasma concentration|48 hours|||hours||Full Range|Median
785052|NCT00834808|Primary|Cmax|Maximum plasma concentration.|48 hours|||ng/mL||Standard Deviation|Mean
785053|NCT00834808|Primary|AUC(0-inf)|Area under the plasma concentration versus time curve extrapolated to infinity. h = hours|48 hours|||ng.h/mL||Standard Deviation|Mean
785054|NCT00834808|Primary|AUC(0-t)|"Area under the plasma concentration versus time curve to the last measurable concentration.
h = hours"|48 hours|||ng.h/mL||Standard Deviation|Mean
785055|NCT00834834|Secondary|Number of Participants With Suicide Events|Data on suicidal behavior was collected with the Columbia Suicide History Interview (CSHI), a semi-structured interview developed by our group. It is used to elicit history of the individual’s actual suicide attempts , as well as specific questions concerning the circumstances surrounding any suicidal behavior and its degree of medical lethality. In addition to obtaining measurements of actual suicide attempts, the CSHI also captures suicide-related behaviors such as aborted and interrupted suicide attempts. An actual suicide attempt is operationally defined by the CSHI as a self-injurious act performed with at least some intent to die.|measured after 6 months of treatment|||participants|||Number
785056|NCT00834834|Primary|Suicide Events|Data on suicidal behavior was collected with the Columbia Suicide History Interview (CSHI), a semi-structured interview developed by our group. It is used to elicit history of the individual’s actual suicide attempts , as well as specific questions concerning the circumstances surrounding any suicidal behavior and its degree of medical lethality. In addition to obtaining measurements of actual suicide attempts, the CSHI also captures suicide-related behaviors such as aborted and interrupted suicide attempts. An actual suicide attempt is operationally defined by the CSHI as a self-injurious act performed with at least some intent to die.|Measured after 6 months of treatment|||suicide events|||Number
785057|NCT00834873|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Carvedilol in Plasma|Bioequivalence based on AUC0-t|Blood samples collected over 60 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
785058|NCT00834873|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Carvedilol in Plasma|Bioequivalence based on AUC0-inf|Blood samples collected over 60 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
785059|NCT00834873|Primary|Cmax - Maximum Observed Concentration - Carvedilol in Plasma|Bioequivalence based on Cmax|Blood samples collected over 60 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
785060|NCT00834886|Primary|To Investigate the Efficacy on Sleep Onsel Latency of Bright Light Therapy and Melatonin Treatment Using a 4 Armed Placebo Controlled Design. Main Outcome Measures: Sleep Log, Actigraphy and Psychological Tests.|Actigraphy, sleep onset latency (SOL). An actigraph is a wrist-worn movement sensor that objectively record motor activity. Participants used an event button to mark bed time and rise time. The actiwatch is waterproof and participants were instructed not to take it off at any time during the data collection peroid.|1 day after 2-week treatment ended|||Minutes||Standard Deviation|Mean
785061|NCT00834886|Primary|To Investigate the Efficacy on Subjective Sleepiness of Bright Light Therapy and Melatonin Treatment Using a 4 Armed Placebo Controlled Design. Main Outcome Measures: Sleep Log, Actigraphy and Psychological Tests.|"Subjective sleepiness; Karolinska sleepiness scale (KSS). The KSS is a scale in which the subjects rate their concurrent sleepiness level. The scale is verbally anchored with steps ranging from 1 (very alert) to 9 (very sleepy, fighting sleep, effort to stay awake)."|1 day after 2-week treatment ended|All participants in the four arms||units on a scale||Standard Deviation|Mean
785062|NCT00834886|Primary|To Investigate the Efficacy on Rise Time of Bright Light Therapy and Melatonin Treatment Using a 4 Armed Placebo Controlled Design. Main Outcome Measures: Sleep Log, Actigraphy and Psychological Tests.|"Sleep diary, rise time (when participants rise from bed in the morning, self-report) before and after a randomized controlled 4 armed treatment study including a follow-up 3 months later.
Midnight is 0000; in the outcome measure table the value is given in minutes after midnight.
i.e. 530 equals 08:50 in the morning."|1 day after two-week treatment ends|||Minutes||Standard Deviation|Mean
785063|NCT00834899|Primary|Change in Platelet Count|Change in platelet counts occurring anytime from randomization up to day 35 (final follow-up visit).|Up to 35 days|||x 10^9/L||Full Range|Median
785064|NCT00834899|Secondary|Effect of Eptifibatide on Duration of Hospitalization|The duration of hospitalization will be defined as the period from randomization to the time an order for discharge from the hospital is written.|Up to 7 days|Intention to treat||Days||Full Range|Median
785065|NCT00834899|Secondary|Effect of Eptifibatide on Duration of Acute Pain Episodes|"The duration of the pain episode will be defined as the time from randomization to termination of the pain episode. The pain episode will be considered terminated when the patient states that the crisis is resolved (defined as being ready to go home on oral analgesics) or all of the following criteria are met:
Pain relief (pain scores ≤ 40) maintained for at least 2 consecutive readings (assessed using a visual analog scale with measurements from 0 - 100, where 0 is no pain and 100 is worst imaginable pain).
No parenteral analgesics have been administered for at least 12 hours.
Ability to walk normally (unless he/she was unable to walk for some other reason prior to the crisis onset)."|Up to 7 days|Intention to treat||Days||Full Range|Median
785066|NCT00834899|Primary|1) Major Bleeding Episodes|Major bleeding episodes are defined as any episode, such as gastrointestinal bleeding or intracranial bleed that typically leads to hospitalization or other prolonged bleeding requiring a blood transfusion|Up to 35 days|Intention to treat||participants|||Number
785067|NCT00834912|Secondary|t1/2|Apparent terminal elimination half-life (t1/2)|48 hours|Data from all randomized subjects who completed at least 2 periods of the study are presented. The pharmacokinetic variable T1/2 of one subject for Tramadol HCl 300 mg (Confab Laboratories) fasting were not used in the analyses due to the morphology of the plasma concentration-time curves.||hours||Standard Deviation|Mean
785068|NCT00834912|Secondary|Tmax|Time to maximum plasma concentration (Tmax)|48 hours|Data from all randomized subjects who completed at least 2 periods of the study are presented.||hours||Full Range|Median
785069|NCT00834912|Primary|Cmax|Maximum plasma concentration (Cmax)|48 hours|Data from all randomized subjects who completed at least 2 periods of the study are presented.||ng/mL||Standard Deviation|Mean
785070|NCT00834912|Primary|AUC(0-∞)|"The area under the plasma concentration (AUC) curve was estimated by extrapolating to infinity AUC0–t. The extrapolation to infinity was done by regression with the last log-transformed data to estimate the terminal area by means of the line that maximized R’2 (coefficient of determination). The units are ng.h/mL.
h=hours"|48 hours|Data from all randomized subjects who completed at least 2 periods of the study are presented. The pharmacokinetic variables AUC(0-∞) of one subject for Tramadol HCl 300 mg (Confab Laboratories) fasting were not used in the analyses due to the morphology of the plasma concentration-time curves.||ng.h/mL||Standard Deviation|Mean
785071|NCT00834912|Primary|AUC(0-t)|Area under the plasma concentration (AUC) versus time curve to the last measurable concentration.|48 hours|Data from all randomized subjects who completed at least 2 periods of the study are presented.||ng.h/mL||Standard Deviation|Mean
785072|NCT00834964|Secondary|AUC0-t - O-Desmethylvenlafaxine in Plasma|Informational Purposes Only|Blood samples collected over24 hour period|Data from first 24 completed subjects were included in the statistical analysis per protocol.||ng*h/mL||Standard Deviation|Mean
785073|NCT00834964|Secondary|AUC0-inf - O-Desmethylvenlafaxine in Plasma|Informational Purposes Only|Blood samples collected over 24 hour period|Data from first 24 completed subjects were included in the statistical analysis per protocol.||ng*h/mL||Standard Deviation|Mean
785078|NCT00834977|Secondary|AUC0-t - Benazaprilat|AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration (per participant)|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
785079|NCT00834977|Primary|AUC0-t - Benazepril|Bioequivalence based on AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration (per participant)|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis||ng*h/mL||Standard Deviation|Mean
785080|NCT00834977|Primary|AUC0-inf - Benazepril|Bioequivalence based on AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis||ng*h/mL||Standard Deviation|Mean
785081|NCT00834977|Secondary|AUC0-inf - Benazeprilat|AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
785082|NCT00834977|Secondary|Cmax - Benazeprilat|Cmax - Maximum observed concentration|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
785083|NCT00834977|Primary|Cmax - Benazepril|Bioequvialence based on Cmax - Maximum observed concentration|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
785084|NCT00834977|Primary|AUC0-t - Amlodipine|Bioequivalence based on AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration (per participant)|Blood samples collected over 168 hour period|One subject was excluded from all statistical analysis for Amlodipine based on a pre-dose plasma concentration greater than 5% of the Cmax value.||pg*h/mL||Standard Deviation|Mean
785085|NCT00834977|Primary|AUC0-inf - Amlodipine|Bioequivalence based on AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)|Blood samples collected over 168 hour period|One subject was excluded from all statistical analysis for Amlodipine based on a pre-dose plasma concentration greater than 5% of the Cmax value.||pg*h/mL||Standard Deviation|Mean
785086|NCT00834977|Primary|Cmax - Amlodipine|Bioequivalence based on Cmax - Maximum observed concentration|Blood samples collected over 168 hour period|One subject was excluded from all statistical analysis for Amlodipine based on a pre-dose plasma concentration greater than 5% of the Cmax value.||pg/mL||Standard Deviation|Mean
785087|NCT00834990|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||µg*h/mL||Standard Deviation|Mean
785088|NCT00834990|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||µg*h/mL||Standard Deviation|Mean
785089|NCT00834990|Primary|Cmax (Maximum Observed Concentration)|Bioequivalence based on Cmax.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||µg/mL||Standard Deviation|Mean
785090|NCT00835003|Secondary|Pediatric Admission and Morbidity||From birth until 2 years of age||||||
785091|NCT00835003|Secondary|Pediatric Admission and Morbidity||2 months post partum||||||
785092|NCT00835003|Secondary|Post Partum Depression||2 months||||||
785093|NCT00835003|Secondary|Maternal Satisfaction With Timing of Elective Caesarean Section||2 months||||||
785094|NCT00835003|Secondary|Maternal Fever, Wound Infection, Need of Wound Operative Revision and Antibiotics, Duration of Admission||30 days||||||
785095|NCT00835003|Secondary|Maternal Haemorrhage in ml or Organ Laceration During Caesarean Section.||30 days||||||
785096|NCT00835003|Secondary|Duration of Neonatal Treatment With Ventilator, CPAP, Oxygen and/or Antibiotics||30 days||||||
785097|NCT00835003|Secondary|Neonatal Diagnoses||30 days||||||
785098|NCT00835003|Primary|Neonatal Admission After Elective Caesarean Section||48 hours|||participants|||Number
785099|NCT00835042|Secondary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) of Moexiprilat.|Informational comparison of AUC0-inf values for the metabolite Moexiprilat.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
785100|NCT00835042|Secondary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) of Moexiprilat.|Informational comparison of AUC0-t values for the metabolite Moexiprilat.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
785101|NCT00835042|Secondary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma) of Moexiprilat.|Informational comparison of Cmax values for the metabolite Moexiprilat.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
785102|NCT00835042|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) of Hydrochlorothiazide.|Bioequivalence based on AUC0-inf.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
785103|NCT00835042|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) of Hydrochlorothiazide.|Bioequivalence based on AUC0-t.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
785104|NCT00835042|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma) of Hydrochlorothiazide.|Bioequivalence based on Cmax.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
785105|NCT00835042|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) of Moexipril.|Bioequivalence based on AUC0-inf.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
785108|NCT00835068|Secondary|Subjective Assessment of Ease of Use by Participant|Participants assessed ease of use of BeneFIX as very good, good, moderate and bad at each follow-up visit. Results were summarized for the latest (most recent), worst and best assessment of BeneFIX done by the participant.|Baseline up to Year 4.75|Efficacy population. Efficacy population included only those participants who were previously treated with BeneFIX.||participants|||Number
785109|NCT00835068|Secondary|Subjective Assessment of Efficacy by Physician|Participating physician assessed efficacy of BeneFIX as very good, good, moderate and bad at follow-up visit. Results were summarized for the latest (most recent), worst and best assessment of BeneFIX done by the physician.|Baseline up to Year 4.75|Efficacy population. Efficacy population included only those participants who were previously treated with BeneFIX.||participants|||Number
785110|NCT00835068|Secondary|Dose Per Injection of BeneFIX|Dose per injection during prophylaxis and on demand period were reported. All periods with at least one injection per week were considered as prophylaxis period. All prophylaxis periods of less than a month were reviewed and cross-checked with the treatment scheme planned at the previous visit to confirm if they were real prophylaxis periods or preventive injections periods. On demand treatment period included the total duration of follow up excluding duration of both prophylaxis and preventive injection treatment scheme. Participants may be represented in more than 1 category.|Baseline up to Year 4.75|Efficacy population. Efficacy population included only those participants who were previously treated with BeneFIX. Here, ‘n’ signifies participants evaluable for this measure during the specified treatment period.||IU/kg||Standard Deviation|Mean
785111|NCT00835068|Secondary|Subjective Assessment of Efficacy by Participant|Participants assessed efficacy of BeneFIX as very good, good, moderate and bad at each follow-up visit. Results were summarized for the latest (most recent), worst and best assessment of BeneFIX done by the participant.|Baseline up to Year 4.75|Efficacy population. Efficacy population included only those participants who were previously treated with BeneFIX.||participants|||Number
785112|NCT00835068|Secondary|Total Consumption of BeneFIX|Total consumption of BeneFIX included consumption during prophylaxis, on demand, during bleeding episodes, preventive injections, surgeries or immune tolerance.|Baseline up to Year 4.75|Safety population included all participants who received at least one dose of BeneFIX. Participants with at least one follow-up visit were evaluable for this outcome measure.||International Unit (IU)||Standard Deviation|Mean
785113|NCT00835068|Secondary|Number of Bleeding Episodes Requiring Treatment by Injection|Number of injections (1, 2, 3 or greater than or equal to [>= 4]) required to treat the bleeding episodes during prophylaxis and on demand period were reported. All periods with at least one injection per week were considered as prophylaxis period. All prophylaxis periods of less than a month were reviewed and cross-checked with the treatment scheme planned at the previous visit to confirm if they were real prophylaxis periods or preventive injections periods. On demand treatment period included the total duration of follow up excluding duration of both prophylaxis and preventive injection treatment scheme.|Baseline up to Year 4.75|Efficacy population. Efficacy population included only those participants who were previously treated with BeneFIX. Here, 'number of bleeding episodes analyzed' signifies episodes evaluable for this measure. ‘n’ signifies those bleeding episodes with injection data available during specified period.||bleeding episodes|Participants||Number
785114|NCT00835068|Secondary|Number of Bleeding Episodes|Number of bleeding episode during prophylaxis and on demand period were reported. All periods with at least one injection per week were considered as prophylaxis period. All prophylaxis periods of less than a month were reviewed and cross-checked with the treatment scheme planned at the previous visit to confirm if they were real prophylaxis periods or preventive injections periods. On demand treatment period included the total duration of follow up excluding duration of both prophylaxis and preventive injection treatment scheme. Efficacy population included only those participants who were previously treated with BeneFIX. Here, ‘n’ signifies participants evaluable for this measure during the specified treatment period. Participants may be represented in more than 1 category.|Baseline up to Year 4.75|Efficacy population: participants with basal FIX activity less than or equal to (<=) 1 percent (%) with real exposure days in diary at least 70% of planned exposure days for prophylaxis period, and without FIX inhibitor before or during study (no FIX inhibitor history at baseline; FIX inhibitor titer <0.6 Bethesda Unit [BU] during follow up).||bleeding episodes|||Number
785115|NCT00835068|Primary|Number of Participants With Events of Special Interest|Events of special interest included allergic reactions, red blood cell (RBC) agglutination phenomena, lack of efficacy/low recovery, thrombotic events and onset of factor IX (FIX) inhibitor. Participants may be represented in more than 1 category.|Baseline up to Year 4.75|Safety population included all participants who received at least one dose of BeneFIX.||participants|||Number
785116|NCT00835068|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) by Relationship After Safety Amendment|AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug as per participating physician. AEs included SAEs as well as non-serious AEs which occurred after the safety amendment. After the safety amendment, all AEs/SAEs were collected irrespective of their relationship to BeneFIX.|Year 3.5 up to 4.75|Safety population included all participants who received at least one dose of BeneFIX. Previously untreated participants were not evaluable for this outcome measure due to discontinuation prior to safety amendment.||participants|||Number
785117|NCT00835068|Primary|Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) Prior to Safety Amendment|A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included SAEs as well as non-serious AEs which occurred prior to safety amendment. Prior to safety amendment, only AEs/SAEs deemed related to BeneFIX as per participating physician were collected.|Baseline up to Year 3.5|Safety population included all participants who received at least one dose of BeneFIX.||participants|||Number
785121|NCT00835120|Secondary|Change in Clinical Global Impressions-Bipolar Version (CGI-BP)|The CGI-BP asks the clinician one question: “Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?” which is rated on the following seven-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients.|Week 0 - Week 8|||units on a scale||Standard Error|Least Squares Mean
785122|NCT00835120|Secondary|Remission Rates Based on IDS-CR, QIDS-SR, and MADRS Scores|A participant is considered in remission if their total score on the MADRS is > 7, their total score on the QIDS-SR16 > 6 and/or their total score on the IDS-CR is > 12 at Week 8.|Week 0 - Week 8|||participants|||Number
785123|NCT00835120|Secondary|Response Rates on the IDS-CR, Montgomery Asberg Depression Rating Scale (MADRS) and Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR)|A participant is considered to have responded if their total score on either the MADRS or QIDS-SR16 decreases by at least 50% between their Week 0 visit and Week 8 visit.|Week 0 - Week 8|||participants|||Number
785124|NCT00835120|Secondary|Change in Quick Inventory of Depressive Symptoms-Self Report (QIDS-SR16) Total Score|The QIDS-SR16 is a 16-item, self report assessment. Total scores can range from 0 to 27, with higher scores indicating a worse outcome|Week 0 - Week 8|||units on a scale||Standard Error|Least Squares Mean
785125|NCT00835120|Primary|Change in the Inventory of Depressive Symptomatology-Clinician Rated (IDS-CR) Score|Inventory of Depressive Symptoms-Clinician rated, 30 item (IDS-C30) score change from baseline to study endpoint. IDS-C30 total scores can range from 0 to 84, with higher scores indicating a worse outcome|Week 0 - Week 8|||units on a scale||Standard Error|Least Squares Mean
785126|NCT00835146|Primary|AUC0-72 (Area Under the Concentration-time Curve From Time Zero to Time of 72 Hours)|Bioequivalence based on AUC0-72.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
785127|NCT00835146|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Cmax.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
785128|NCT00835159|Primary|Incidence of POD|Is the incidence of POD not affected by rivastigmine treatment or not.|72 hours postoperatively|||participants|||Number
785129|NCT00835172|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
785130|NCT00835172|Primary|AUCinf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUCinf|Blood samples collected over 24 hour period|The parameter of AUCinf could not be estimated for three subjects.||ng*h/mL||Standard Deviation|Mean
785131|NCT00835172|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
785132|NCT00835185|Secondary|Kirsten Rat Sarcoma (KRAS) Mutation Status|Tumor tissues collected prior to study drug administration were evaluated for the presence or absence of KRAS mutations by a retrospective analysis.|Baseline|All enrolled participants who had assessment of tumor tissue samples at baseline.||participants|||Number
785133|NCT00835185|Secondary|Change From Baseline in Tumor Size||Baseline, 29 Months|Zero participants were analyzed, the outcome measure was registered in error.|||||
785134|NCT00835185|Secondary|Vss at Study Day 1 of Cycles 2 Through 6||Day 1 Cycles 2 through 6 predose and 1 hour postdose|Zero participants were analyzed, Vss results were not collected.|||||
785135|NCT00835185|Secondary|CL at Study Day 1 of Cycles 2 Through 6||Day 1 Cycles 2 through 6 predose and 1 hour postdose|Zero participants were analyzed, CL results were not collected.|||||
785136|NCT00835185|Secondary|t1/2 at Study Day 1 of Cycles 2 Through 6||Day 1 Cycles 2 through 6 predose and 1 hour post dose|Zero participants were analyzed, t1/2 results were not collected.|||||
785137|NCT00835185|Secondary|Area Under the Curve (AUC) at Study Day 1 of Cycles 2 Through 6||Day 1 Cycles 2 through 6 predose and 1 hour postdose|Zero participants were analyzed, AUC results were not collected.|||||
785138|NCT00835185|Secondary|Cmax at Study Day 1 of Cycles 2 Through 6||Day 1 Cycles 2 through 6 predose and 1 hour postdose|Zero participants were analyzed, Cmax results were not collected.|||||
785139|NCT00835185|Secondary|Volume of Distribution (Vss) of IMC-11F8 at Study Day 1 of Cycle 1|Vss is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug at steady-state.|Cycle 1 Day 1 predose, immediately after infusion, and 1, 2, 4, 24, 72, 96, 144, 168 and 236 hours postdose|All enrolled participants who received any quantity of study drug and had PK data available to calculate Vss.||milliliters (mL)||Geometric Coefficient of Variation|Geometric Mean
785140|NCT00835185|Secondary|Clearance (CL) of IMC-11F8 at Study Day 1 of Cycle 1|CL is the volume of plasma (or blood) from which the drug is completely removed, or cleared, in a given time.|Cycle 1 Day 1 predose, immediately after infusion, and 1, 2, 4, 24, 72, 96, 144, 168 and 236 hours postdose|All enrolled participants who received any quantity of study drug and had PK data available to calculate CL.||milliliters/hour (mL/h)||Geometric Coefficient of Variation|Geometric Mean
785141|NCT00835185|Secondary|Half-Life (t1/2) of IMC-11F8 at Study Day 1 of Cycle 1|The t1/2 is the time measured for the plasma concentration of the drug to decrease by one half.|Cycle 1 Day 1 predose, immediately after infusion, and 1, 2, 4, 24, 72, 96, 144, 168 and 236 hours postdose|All enrolled participants who received any quantity of study drug and had PK data available to calculate t1/2.||hours (h)||Full Range|Geometric Mean
785142|NCT00835185|Secondary|Area Under the Concentration-Time Curve From Time 0 to Infinity [AUC(0-∞)] of IMC-11F8 at Study Day 1 of Cycle 1||Cycle 1 Day 1 predose, immediately after infusion, and 1, 2, 4, 24, 72, 96, 144, 168 and 236 hours postdose|All enrolled participants who received any quantity of study drug and had PK data available to calculate AUC(0-∞).||micrograms*hour/milliliter (µg*h/mL)]||Geometric Coefficient of Variation|Geometric Mean
785143|NCT00835185|Secondary|Maximum Concentration (Cmax) of IMC-11F8 at Study Day 1 of Cycle 1||Cycle 1 Day 1 predose, immediately after infusion, and 1, 2, 4, 24, 72, 96, 144, 168 and 236 hours postdose|All enrolled participants who received any quantity of study drug and had pharmacokinetic (PK) data available to calculate Cmax.||micrograms/milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
785144|NCT00835185|Secondary|Serum Anti-IMC-11F8 Antibody Assessment (Immunogenicity)|A participant was considered to have an anti-IMC-11F8 response if there were 2 consecutive positive samples or if the final sample tested is positive. Participants with a baseline sample positive for anti-IMC-11F8 antibodies were considered unevaluable for immunogenicity. A sample was considered positive for IMC-11F8 antibodies if it exhibited a post-baseline treatment emergent antibody level that exceeded the upper 95% confidence interval of the mean determined from the normal anti-IMC 11F8 level found in healthy treatment-naïve individuals.|Baseline up to last day of treatment plus 45 days after last treatment (127 weeks)|All participants who received any amount of study drug and were IMC-11F8 antibody negative at baseline.||participants|||Number
785145|NCT00835185|Secondary|Duration of Response|The duration of response was defined as the time from first confirmed CR or PR to the first time of PD or death due to any cause. CR, PR and PD were defined using RECIST v1.0 criteria. CR was defined as the disappearance of all target and non-target lesions; PR was defined as a ≥30% decrease in the sum of the LD of the target lesions, taking as reference the baseline sum of the LD; PD was defined as a ≥20% increase in the sum of LD of target lesions, taking as reference the smallest sum of the LD recorded since treatment started or the appearance of new lesions and/or unequivocal progression of existing nontarget lesions. Participants with CR or PR who had no PD or death at the time of the data inclusion cutoff, the duration of response was censored at their last contact.|Time of response to time of measured PD or death up to 30 months|All enrolled participants who received any quantity of study drug and had confirmed CR or PR. Participants censored =2.||months||95% Confidence Interval|Median
785146|NCT00835185|Secondary|Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) or Death|The number of participants who experienced AEs, SAEs or death during the study and within 30 days of last dose. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.|First dose to end of treatment and 30-day post treatment follow-up up to 31 months|All enrolled participants who received any quantity of study drug.||participants|||Number
785147|NCT00835185|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time from date of first dose to the first observation of disease progression or death due to any cause. Progressive disease (PD) was determined using RECIST v1.0 criteria. PD was defined as ≥20% increase in the sum of LD of target lesions, taking as reference the smallest sum of the LD recorded since treatment started or the appearance of new lesions and/or unequivocal progression of existing nontarget lesions. PFS was estimated by the Kaplan-Meier method. Participants who had no PD or death at the time of the data inclusion cutoff, PFS was censored at their last tumor assessment prior to the earliest of the following events: 2 or more missed visits, additional cancer treatment or the end of the follow-up period.|First dose to measured PD or death up to 30 months|All enrolled participants who received any quantity of study drug. Participants censored =13.||months||95% Confidence Interval|Median
785148|NCT00835185|Secondary|Overall Survival (OS)|OS was defined as the duration from the date of first dose to the date of death from any cause. OS was estimated by the Kaplan-Meier method. Participants who were alive at the time of the data inclusion cutoff or lost to follow-up, OS was censored at the last contact.|First dose to date of death from any cause up to 30 months|All enrolled participants who received any quantity of study drug. Participants censored =14.||months||95% Confidence Interval|Median
785149|NCT00835185|Primary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response )|CR and PR defined using Response Evaluation Criteria In Solid Tumors (RECIST) version (v) 1.0 criteria. CR was defined as the disappearance of all target and non-target lesions and PR defined as a ≥30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD. Percentage of participants was calculated as: (total number of participants with CR or PR from start of the treatment until disease progression or recurrence) / (total number of participants treated) * 100.|Up to 30 Months|All enrolled participants who received any quantity of study drug.||percentage of participants||95% Confidence Interval|Number
785150|NCT00835198|Secondary|Change From Baseline in Non-Inflammatory Lesion Counts (Open and Closed Comedones) at Week 12|"Change from baseline in non-inflammatory lesion counts (open/closed comedones) at week 12. Comedones are small bumps on the skin (lesions) caused by acne and found at the opening of a skin pore. Open comedones (also known as a blackheads) have a microscopic opening to the skin surface, while closed comedones (also known as whiteheads or pimples) lack the opening to the skin. A negative number change from baseline indicates a reduction in lesion counts (improvement)."|Baseline, Week 12|Intent-to-treat (ITT), which included all patients who started the study (randomized).||Number of lesions||Standard Deviation|Mean
785151|NCT00835198|Secondary|Change From Baseline in Overall Disease Severity at Week 12|Change from baseline in overall disease severity at week 12. The overall disease severity was evaluated by the investigator using a 7-point scale to rate the overall acne severity (lesions, inflammation, facial redness and skin condition), where 0=no acne lesions and 6=most severe acne. A negative number change from baseline indicates a reduction in overall acne disease severity (improvement).|Baseline, Week 12|Intent-to-treat (ITT), which included all patients who started the study (randomized).||Scores on a scale||Standard Deviation|Mean
785152|NCT00835198|Secondary|Change From Baseline in Investigator Global Assessment at Week 12|Change from baseline in the Investigator Global Assessment (IGA) at week 12. The IGA is a 5-point scale used by the investigator to assess overall acne severity, where 0 equals clear skin (no evidence of acne) and 4 equals severe acne. A negative number change from baseline indicates a reduction in acne severity (improvement).|Baseline, Week 12|Intent-to-treat (ITT), which included all patients who started the study (randomized).||Scores on a scale||Standard Deviation|Mean
785153|NCT00835198|Primary|Change From Baseline in Inflammatory Lesion Counts (Papules, Pustules and Nodules) at Week 12|Change from baseline in inflammatory lesion counts (papules, pustules and nodules) at week 12. Papules and nodules are round, solid elevations of the skin with no visible fluid; papules are smaller (less than 5 or 10 millimeters in width and depth) and nodules are larger (greater than 5 or 10 millimeters in width and depth). Pustules are small elevations of the skin containing cloudy material. A negative number change from baseline indicates a reduction in lesion counts (improvement).|Baseline, Week 12|Intent-to-treat (ITT), which included all patients who started the study (randomized).||Number of Lesions||Standard Deviation|Mean
785154|NCT00835211|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 12 hour period|Data from all subjects who completed the study were included in the statistical analysis.||pg*h/mL||Standard Deviation|Mean
785158|NCT00835237|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|An SAE is any untoward medical occurrence that: results in death, is lifethreatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|From the vaccintation up to Day 182|||subjects|||Number
785159|NCT00835237|Primary|Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibodies Concentration|Concentration for anti-PT, anti-FHA and anti-PRN antibodies given as geometric mean concentration (GMC) in Enzyme-Linked Immuno Sorbent Assay (ELISA) units per millilitre (EL.U/mL)|Before (PRE) and one month after vaccination (POST)|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results||EL.U/mL||95% Confidence Interval|Geometric Mean
785160|NCT00835237|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Within the 31-day (Day 0-30) post-vaccination period|||subjects|||Number
785161|NCT00835237|Secondary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed include fatigue, gastrointestinal symptoms, headache, and fever|Within the 4-day (Day 0-3) post-vaccination period|Analysis was performed on the Total Vaccinated cohort on subjects with available results||subjects|||Number
785162|NCT00835237|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling.|Within the 4-day (Day 0-3) post-vaccination period|Analysis was performed on the Total Vaccinated cohort on subjects with available results||subjects|||Number
785163|NCT00835237|Secondary|Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentrations Above the Cut-off, Using Alternative Definitions.|"Vaccine response defined as:
For initially seronegative subjects (< 5 EL.U/mL ), antibody concentration ≥ 10 EL.U/mL one month after vaccination.
For initially seropositive subjects (≥ 5 EL.U/mL), antibody concentration one month after vaccination ≥ 2 fold the pre-vaccination antibody concentration."|One month after vaccination|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results||subjects|||Number
785164|NCT00835237|Secondary|Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentrations Above the Cut-off|"Booster response defined as :
For initially seronegative subjects (< 5 EL.U/mL), antibody concentration ≥ 20 EL.U/mL one month after vaccination.
For initially seropositive subjects (≥ 5 EL.U/mL) with pre-vaccination antibody concentration < 20 EL.U/mL: antibody concentration one month after vaccination ≥ 4 fold the pre-vaccination antibody concentration.
For initially seropositive subjects (≥ 5 EL.U/mL) with pre-vaccination antibody concentration ≥ 20 EL.U/mL : antibody concentration one month after vaccination ≥ 2 fold the pre-vaccination antibody concentration."|One month after vaccination|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results||subjects|||Number
785165|NCT00835237|Secondary|Number of Subjects With Vaccine Response for Anti-T and Anti-D Antibodies Concentrations Above the Cut-off|"Booster response defined as :
For initially seronegative subjects (< 0.1 IU/mL), antibody concentration ≥ 0.4 IU/mL one month after vaccination.
For initially seropositive subjects (≥ 0.1 IU/mL): antibody concentration one month after vaccination ≥ 4 fold the pre-vaccination antibody concentration."|One month after vaccination|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results||subjects|||Number
785166|NCT00835237|Secondary|Anti-T and Anti-D Antibody Concentrations|Concentrations for anti-T and anti-D antibodies given as GMC in IU/mL.|Before (PRE) and one month after vaccination (POST)|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results||IU/mL||95% Confidence Interval|Geometric Mean
785167|NCT00835237|Primary|Number of Subjects With Antibody Concentration Against Vaccine Antigens, Above a Protocol Defined Cut-off Value|"Antibodies against vaccine antigens assessed were: anti-diphtheria (anti-D) and anti-tetanus (anti-T).
Anti-D antibody cut-off value assessed was ≥ 0.1 International Unit per milliliter (IU/mL)
Anti-T antibody cut-off values assessed were ≥ 0.1 IU/mL and ≥ 1.0 IU/mL"|One month after vaccination.|Analysis was performed on the According-To-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available results||subjects|||Number
785168|NCT00835263|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 120 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
785169|NCT00835263|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 120 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
785170|NCT00835263|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 120 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
785171|NCT00835276|Primary|AUC0-inf = Area Under the Concentration-time Curve From Time Zero to Infinity.|Bioequivalence based on AUC0-inf.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
785172|NCT00835276|Primary|AUC0-t = Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration (Per Participant)|Bioequivalence based on AUC0-t.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
785173|NCT00835276|Primary|Cmax = Maximum Observed Concentration.|Bioequivalence based on Cmax.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
785174|NCT00835341|Secondary|Cancer-free Survival Time for Patients With Oral Epithelial Dysplasia||from 3 months to 124 months||||||
785193|NCT00835484|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 14 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
785194|NCT00835484|Primary|Cmax (Maximum Observed Concentration)|Bioequivalence based on Cmax.|Blood samples collected over a 14 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
785175|NCT00835341|Primary|The Number of Participants With Both Clinical and Histological Evidence of Malignant Transformation of Oral Epithelial Dysplasia|The follow-up examination was carried out with a 3-month interval. Re-biopsy was done as clinically indicated, e.g. the lesion recurs or has tendency for malignant development. Pathologic diagnosis was made by at least two pathologists without the knowledge of baseline p16 methylation, based on the World Health Organization's criteria, at Peking University School of Stomatology. The number of participants with malignant transformation of oral dysplasia was calculated based on the number of participants with oral dysplasia progressed to carcinoma by the end of the trial in each cohorts.|from 3 months to 124 months|||participants|||Number
785176|NCT00835354|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
785177|NCT00835354|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
785178|NCT00835354|Primary|Cmax (Maximum Observed Concentration)|Bioequivalence based on Cmax.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
785179|NCT00835367|Secondary|AUC0-t - Benazeprilat|AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration (per participant)|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
785180|NCT00835367|Primary|AUC0-t - Benazepril|Bioequivalence based on AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration (per participant)|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
785181|NCT00835367|Primary|AUC0-inf - Benazepril|Bioequivalence based on AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
785182|NCT00835367|Secondary|AUC0-inf - Benazeprilat|AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
785183|NCT00835367|Secondary|Cmax - Benazeprilat|Cmax - Maximum observed concentration|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
785184|NCT00835367|Primary|Cmax - Benazepril|Bioequivalence based on Cmax - Maximum observed concentration|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
785185|NCT00835367|Primary|AUC0-t - Amlodipine|Bioequivalence based on AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration (per participant)|Blood samples collected over 168 hour period|One subject was excluded from all statistical analysis for Amlodipine based on a pre-dose plasma concentration greater than 5% of the Cmax value.||pg*h/mL||Standard Deviation|Mean
785186|NCT00835367|Primary|AUC0-inf - Amlodipine|Bioequivalence based on AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)|Blood samples collected over 168 hour period|One subject was excluded from all statistical analysis for Amlodipine based on a pre-dose plasma concentration greater than 5% of the Cmax value.||pg*h/mL||Standard Deviation|Mean
785187|NCT00835367|Primary|Cmax - Amlodipine|Bioequivalence based on Cmax - Maximum observed concentration|Blood samples collected over 168 hour period|One subject was excluded from all statistical analysis for Amlodipine based on a pre-dose plasma concentration greater than 5% of the Cmax value.||pg/mL||Standard Deviation|Mean
785188|NCT00835380|Secondary|Serious Adverse Experiences and Systemic Adverse Experiences Occurring Within 14 Days After Each Vaccination, and Injection-site Complaints Occurring Day 1 Through Day 5 After Each Vaccination|All adverse experiences were collected from the time the consent form was signed through 14 days following the first vaccination(s) and from the time of the second vaccination through 14 days thereafter. The parent/legal guardian of each participant were requested to record injection-site adverse experiences and monitor the subject’s temperature daily on the Vaccination Report Card for Day 1 thereafter for 4 additional calendar days, and record all systemic adverse experiences that occur during the 14-day period after each injection.|For serious adverse experiences and systemic adverse experiences: 14 days follow-up after each dose of vaccination; For injection-site adverse experiences: 5 days follow-up after each dose of vaccination|Safety population, defined as all subjects who were vaccinated at least one dose and had safety follow-up data||participants|||Number
785189|NCT00835380|Primary|Hepatitis A Virus (HAV) Seroconversion Rate, i.e. the Percentage of Subjects Who Were Seronegative at Baseline and Developed Seropositive at Month 7 After Administration of a 2-dose Regime of Vaccines.|"Seroconversion rate = (number of subjects with seronegative at baseline and developed seropositive at Month 7)/(number of subjects with seronegative at baseline regardless HAV serum status at Month 7). Measure serum HAV (hepatitis A virus) antibody at Day 0 prior to vaccination and at Month 7 after administration of a 2-dose regimen of vaccines.
HAV antibody titers were determined by Wantai ELISA kit for serum antibody response to HAV. Seropositive was defined as HAV antibody titer ≥ 50 mIU/mL. Seronegative was defined as HAV antibody titer < 50 mIU/mL."|Collect blood sample for HAV antibody testing at Day 0 prior to vaccination, and Month 7 (4 weeks after administration of a 2-dose regimen of vaccines at Month 6)|Per-protocol population, defined as all HAV-susceptible subjects who completed the vaccination regimen within acceptable day ranges, had 2 valid serology results on Day 0 and Month 7, and met all inclusion/exclusion criteria.||Percentage of Participants|||Number
785190|NCT00835406|Primary|Bioequivalence Based on Ae0-36|Ae0-36 = cumulative urine excretion|Urine collected over 36 hour period|||ng/mL||Standard Deviation|Geometric Mean
785191|NCT00835406|Primary|Bioequivalence Based on Rmax|Rmax = maximum rate of urinary excretion|Urine collected over 36 hour period|||ng/mL||Standard Deviation|Geometric Mean
785195|NCT00835497|Primary|AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)]- Metformin|Bioequivalence based on AUC0-t|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
785196|NCT00835497|Primary|AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Metformin|Bioequivalence based on AUC0-inf|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
785197|NCT00835497|Primary|Cmax (Maximum Observed Concentration) - Metformin in Plasma|Bioequivalence based on Cmax|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
785198|NCT00835497|Primary|AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)] - Glipizide|Bioequivalence based on AUC0-t|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
785199|NCT00835497|Primary|AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)]- Glipizide|Bioequivalence based on AUC0-inf|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
785200|NCT00835497|Primary|Cmax (Maximum Observed Concentration) - Glipizide in Plasma|Bioequivalence based on Cmax|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
785201|NCT00835510|Primary|Therapeutic Cure Non-Inferiority Comparison of Butenafine Cream and Lotrimin Ultra|Patient was cured both by symptoms (Clinical Cure) and by the results of fungal testing (Mycological Cure).|42 days|Patients with negative cultures excluded. Use per protocol population||Participants|||Number
785202|NCT00835510|Secondary|Safety and Adverse Event Profile||42 days||||||
785203|NCT00835510|Secondary|Clinical Cure|"The following 8 signs and symptoms are rated at each visit:
Erythema Fissuring Maceration Vesiculation Desquamation/scaling Exudation Pruritus Stinging/Burning
Each symptom is evaluated using the following scale:
0 = None- Complete absence of any sign or symptom
= Mild – obvious but minimal involvement
= Moderate – something that is easily noted
= Severe – quite marked
Clinical cure is defined as a score of 2 (moderate) or less for erythema and a total score for seven other signs and symptoms less than 2."|42 days|ITT population||Participants|||Number
785204|NCT00835510|Secondary|Mycologic Cure|Negative KOH and fungal culture at day 42|42 days|ITT population||Participants|||Number
785205|NCT00835510|Secondary|Therapeutic Cure|Subject with clinical and mycological cure at day 7|7 days|ITT Population||Participants|||Number
785206|NCT00835510|Primary|Therapeutic Cure - Superiority Analysis|"Therapeutic Cure requires both Clinical Cure and Mycological Cure.
Clinical Cure was based on the following signs and symptoms: fissuring, erythema, maceration, vesiculation, scaling, exudation, pruritus, burning. Each clinical symptom was evaluated using a 0-3 point rating scale: none=0, mild=1, moderate=2 or severe=3. If the score for erythema was ≤ 2 and the sum for all of the other 7 signs and symptoms was <2 then the patient was considered a Clinical Cure.
Mycological Cure: The potassium hydroxide (KOH) and the fungal culture were both negative."|42 days|Patients with negative cultures at baseline are excluded. Efficacy ITT analysis includes all patients with positive baseline cultures, who received at least one dose of medication, had a follow-up visit and had data for the day 42 visit.||Participants|||Number
785207|NCT00835536|Primary|AUC0-72 (Area Under the Concentration-time Curve From Time Zero to Time of 72 Hours)|Bioequivalence based on AUC0-72.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
785208|NCT00835536|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Cmax.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
785209|NCT00835549|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 14 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
785210|NCT00835549|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 14 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
785211|NCT00835549|Primary|Cmax (Maximum Observed Concentration)|Bioequivalence based on Cmax.|Blood samples collected over a 14 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
785212|NCT00835575|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 120 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
785213|NCT00835575|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 120 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
785214|NCT00835575|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Cmax.|Blood samples collected over a 120 hour period.|All participants that completed the study had their samples analyzed.||pg/mL||Standard Deviation|Mean
785215|NCT00835588|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 16 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
785216|NCT00835588|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 16 hour period|Data from all subjects who completed the study were included in the statistical analysis. Not all subjects data could be used to estimate AUC0-inf.||ng*h/mL||Standard Deviation|Mean
785217|NCT00835588|Primary|Cmax - Maximum Observed Concentration - Pantoprazole in Plasma|Bioequivalence based on Cmax|Blood samples collected over 16 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
785219|NCT00835614|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
785220|NCT00835614|Primary|Cmax (Maximum Observed Concentration)|Bioequivalence based on Cmax.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
785221|NCT00835640|Primary|AUC0-inf = Area Under the Concentration-time Curve From Time Zero to Infinity.|Bioequivalence based on AUC0-inf.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
785222|NCT00835640|Primary|AUC0-t = Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration (Per Participant)|Bioequivalence based on AUC0-t.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
785223|NCT00835640|Primary|Cmax = Maximum Observed Concentration.|Bioequivalence based on Cmax.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
785224|NCT00835666|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
785225|NCT00835666|Primary|AUCinf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUCinf|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
785226|NCT00835666|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
785227|NCT00835679|Secondary|Number of Patients With the Given Severity of Post-operative Complications Within the Specified Duration||From day 15 (day of surgery) to 30 days after surgery|No patients accrued to Cohorts B, C, and D, which were to receive the study drugs. Nine patients were accrued in Cohort A; these patients received no study drugs and were to determine normal levels of selected biomarkers.No patients received any study drugs. This study was closed prematurely due to slow accrual.|||||
785228|NCT00835679|Secondary|Number of Patients With the Given Severity of Adverse Event Within a Specified Duration|Number of patients with each grade of adverse event (AE) during the specified timeframe using the Common Terminology Criteria for AEs guide, grades 1-5 with one being mild, five is death.|weekly to day 15, and at followup on day 30|No patients accrued to Cohorts B, C, and D, which were to receive the study drugs. Nine patients were accrued in Cohort A; these patients received no study drugs and were to determine normal levels of selected biomarkers. No patients were accrued to Cohorts B, C, D. This study was closed prematurely due to slow accrual.|||||
785229|NCT00835679|Secondary|Patients With Reduction of Biomarkers in Tumor Tissue|Patients with pre-to-post treatment reduction at least 1 scoring level from baseline on preoperative-day 15 in at least 1 biomarker: total & phi-EGFR, phi-MAPK, phi-Akt, Ki67, phi-FAK, phi-paxillin, phi-Src, capase 3. Determined by 0-4-scale scoring with score determined by percentage of tumor cells positively stained for biomarker in question: minimum 0 (0%), 1 (1-24%), 2 (25-49%), 3 (50-74%), and maximum 4 (75-100%)|study entry to day 15|No patients accrued to Cohorts B, C, and D, who were to receive the study drugs. Nine patients were accrued in Cohort A; these patients received no study drugs and were to determine normal levels of selected biomarkers. No biomarkers were determined; no data available. This study was closed prematurely due to slow accrual.|||||
785230|NCT00835679|Primary|Patients With a Biologic Response|Patients who experienced a pre-to-post treatment reduction of at least 1 scoring level from baseline on preoperative-day 15 in at least 1 biomarker of the pathway being inhibited: epidermal growth factor (EGFR) for Cohort B, sarcoma (Src) for Cohort C, and both EGFR and Src for Cohort D. Blood for these biomarkers will be taken on day of baseline and pre-operatively on day 15. Determined by 0-4-scale scoring with score determined by percentage of tumor cells positively stained for pathway in question: minimum 0 (0%), 1 (1-24%), 2 (25-49%), 3 (50-74%), and maximum 4 (75-100%).|on baseline and preoperatively on day of surgery (day 15)|No patients accrued to Cohorts B, C, and D, who were to receive the study drugs. Nine patients were accrued in Cohort A; these patients received no study drugs and were to determine normal levels of selected biomarkers. No biomarkers were determined; no data available. This study was closed prematurely due to slow accrual.|||||
785231|NCT00835692|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
785232|NCT00835692|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-t|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
785233|NCT00835692|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
785234|NCT00835705|Primary|AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)] - Clavulanic Acid|Bioequivalence based on AUC0-t|Blood samples collected over 10 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
785235|NCT00835705|Primary|AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Clavulanic Acid|Bioequivalence based on AUC0-inf|Blood samples collected over 10 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
785236|NCT00835705|Primary|Cmax (Maximum Observed Concentration) - Clavulanic Acid|Bioequivalence based on Cmax|Blood samples collected over 10 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
785237|NCT00835705|Primary|AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)] - Amoxicillin|Bioequivalence based on AUC0-t|Blood samples were collected over 10 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
785238|NCT00835705|Primary|AUC0-inf - [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Amoxicillin|Bioequivalence based on AUC0-inf|Blood samples were collected over 10 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
785239|NCT00835705|Primary|Cmax (Maximum Observed Concentration) - Amoxicillin|Bioequivalence based on Cmax|Blood samples were collected over 10 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
785247|NCT00835796|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
785248|NCT00835796|Primary|AUCinf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUCinf|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
785249|NCT00835796|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
785250|NCT00835861|Secondary|Number of Babies With Adverse Neonatal Outcomes|Resuscitation in the delivery room, preterm birth < 37 weeks, neonatal intensive care unit care, birth injury or diagnosis of neonatal complication, glucose infusion, antibiotics, or phototherapy.|Delivery until hospital discharge|"For 1 infant in the metformin group, the adverse neonatal outcome data was missing."||number of babies|||Number
785251|NCT00835861|Secondary|Number of Episodes Maternal Hypoglycemia|Maternal glucose < 60 mg/dL|Baseline throughout pregnancy until time of delivery|||Number of episodes|||Number
785252|NCT00835861|Secondary|Percent of Glucose Values at or Below Postprandial Goal (<130 mg/dL)|NUMBER OF ASSESSMENTS OF POSTPRANDIAL GLUCOSE VALUES <130|Baseline throughout pregnancy until time of delivery|||percent of glucose values|||Number
785253|NCT00835861|Secondary|Percent of Glucose Values at or Below Fasting Goal (<95 mg/dL)|NUMBER OF ASSESSMENTS OF FASTING GLUCOSE VALUES <95|Baseline throughout pregnancy until time of delivery|||percent of glucose values|||Number
785254|NCT00835861|Secondary|Glycosylated Hemoglobin (HbA1c) by Pregnancy Trimester||1st, 2nd, and 3rd trimester|||percentage of glycosolated hemoglobin||Inter-Quartile Range|Median
785255|NCT00835861|Secondary|Number of Babies With Neonatal Hypoglycemia|Initial neonatal glucose < 40 mg/dL|Time of delivery through hospital discharge|For 1 infant in each group, the initial neonatal glucose value was missing.||Number of babies|||Number
785256|NCT00835861|Secondary|Maternal Weight Gain||Baseline throughout pregnancy until last prenatal visit.|||kg/week||Inter-Quartile Range|Median
785257|NCT00835861|Secondary|Number of Patients With Obstetric Complications|Maternal complications were stillbirths, major malformations, shoulder dystocia, or postpartum hemorrhage requiring transfusion.|Throughout pregnancy until hospital discharge following delivery.|||participants|||Number
785258|NCT00835861|Primary|Blood Glucose Measurements|Patients self monitored glucose measures throughout pregnancy to aid glycemic control. Fasting morning measures and postprandial measures were taken at 1 hour after breakfast, lunch, and dinner.|Daily fasting and 1-hr post prandial measures were taken from time of enrollment until delivery|For 1 infant in each group, the initial neonatal glucose value was missing.||mg/dL||Inter-Quartile Range|Median
785259|NCT00835900|Secondary|Rates of Smoking Cessation.|To parallel most clinical trials of varenicline, we focused on CO-verified (<11 parts per million) continuous abstinence (not even one puff) during the final 4 weeks of treatment (i.e., post-quit weeks 8 through 11). Participants lost to follow-up were coded as smokers.|12 weeks after quit date.|ITT||Participants|||Count of Participants
785260|NCT00835900|Primary|Change in Smoking Behavior|Change in cigarettes per day from Week 2 to Week 5|Change in cigarettes per day from Week 2 to Week 5|ITT||Change in Cigarettes Per Day||Standard Error|Mean
785261|NCT00835926|Primary|Percentage of Participants With Serum Hemagglutination Inhibition Antibody Titers ≥ 40 Post-Vaccination With Fluzone®|Hemagglutination inhibition antibodies is a measure of the serum antibody to the influenza virus in the vaccine as determined by the hemagglutinin inhibition (HAI) assay|Day 21 Post-vaccination|The Fluzone® antibody titers were analyzed in the per-protocol immunogenicity population.||Percentage of Participants|||Number
785262|NCT00835926|Primary|Percentage of Participants With a ≥ 4-Fold Rise in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination With Fluzone®|Hemagglutination inhibition antibodies is a measure of the serum antibody to the influenza virus in the vaccine as determined by the hemagglutinin inhibition (HAI) assay.|Day 21 Post-vaccination|The vaccine antibody fold rise analysis was in the per-protocol immunogenicity population.||Percentage of Participants|||Number
785263|NCT00835926|Primary|Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Before and After Vaccination With Fluzone®|Hemagglutination inhibition antibodies is a measure of the serum antibody to the influenza virus in the vaccine as determined by the hemagglutinin inhibition (HAI) assay.|Day 0 and Day 21 Post-vaccination|The Geometric mean titers were analyzed in the per-protocol immunogenicity population.||Titers||95% Confidence Interval|Geometric Mean
785264|NCT00835926|Primary|Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone®|"Solicited injection site reactions: Erythema, bruising, induration, and Pain at injection site.
Solicited systemic reaction: Fever (temperature), chills, rash, headache, cough, runny nose, nausea, vomiting, diarrhea, malaise, myalgia, and arthralgia"|Days 0 to 3 Post-vaccination|Safety analysis was on all enrolled and vaccinated participants, intent-to-treat population.||Percentage of Participants|||Number
785265|NCT00835978|Secondary|PFS in Subgroups That Were Defined by Vascular Endothelial Growth Factor A (VEGFA) or Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) Polymorphisms|PFS, defined as the time from randomization to first documentation of objective tumor progression or to death due to any cause, in subgroups that were defined by VEGFA or VEGFR3 polymorphisms. Estimates of the PFS curves from the Kaplan-Meier method were presented.|At baseline - Beginning of the lead-in period (Cycle 1 Day 1)|The Safety Analysis (SA) population consisted of all participants who received at least one dose of study medication with treatment assignments designated according to actual study treatment received.||Months||95% Confidence Interval|Median
785266|NCT00835978|Secondary|ORR in Subgroups That Were Defined by Vascular Endothelial Growth Factor A (VEGFA) or Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) Polymorphisms|ORR, defined as proportion of participants with CR or PR according to RECIST, in subgroups that were defined by VEGFA or VEGFR3 polymorphisms.|At baseline - Beginning of the lead-in period (Cycle 1 Day 1)|The Safety Analysis (SA) population consisted of all participants who received at least one dose of study medication with treatment assignments designated according to actual study treatment received.||Percentage of participants||95% Confidence Interval|Number
785267|NCT00835978|Secondary|Comparison of Ratio of CECs in Blood: CD31+/CD146+ at Each Time Point to Baseline|CECs are noninvasive marker of vascular damage, remodeling, and dysfunction. Samples were collected and following proteins were analyzed: CD31+/CD146+ CECs, CD31+/CD146+ MFI PDGFR-beta, CD31+/CD146+ MFI pPDGFR-beta, CD31+/CD146+ pVEGFR, CD31+/CD146+ MFI VEGFR. The ratio of plasma levels of the biomarkers at the selected time point vs baseline is reported.|At end of the lead-in period (Cycle 1 Day 15), Cycle 2 Day 15 and End of therapy (EOT)|The Biomarker Analysis Set included participants receiving at least one dose of treatment, with a Cycle 1 Day 1 biomarker result for at least one biomarker.||Ratio||Standard Deviation|Mean
785268|NCT00835978|Secondary|Circulating Endothelial Cells (CECs) in Blood: CD31+/CD146+|CECs are noninvasive marker of vascular damage, remodeling, and dysfunction. Samples were collected and following proteins were analyzed: CD31+/CD146+ CECs, CD31+/CD146+ MFI PDGFR-beta, CD31+/CD146+ MFI pPDGFR-beta, CD31+/CD146+ pVEGFR, CD31+/CD146+ MFI VEGFR. The ratio of plasma levels of the biomarkers at the selected time point vs baseline is reported.|At baseline - Beginning of the lead-in period (Cycle 1 Day 1)|The Biomarker Analysis Set included participants receiving at least one dose of treatment, with a Cycle 1 Day 1 biomarker result for at least one biomarker.||Fluorescent Intensity Unit (FIU)||Standard Deviation|Mean
785269|NCT00835978|Secondary|Comparison of the Ratio of CECs in Blood: CD146+/CD105+ at Each Time Point to Baseline|CECs are noninvasive marker of vascular damage, remodeling, and dysfunction. Samples were collected and following proteins were analyzed: CD146+/CD105+ CECs, CD146+/CD105+ MFI platelet derived growth factor receptor (PDGFR)-beta, CD146+/CD105+ MFI phospho-PDGFR (pPDGFR)-beta, CD146+/CD105+ phospho-VEGFR (pVEGFR), CD146+/CD105+ MFI VEGFR. The ratio of plasma levels of the biomarkers at the selected time point vs baseline is reported.|At end of the lead-in period (Cycle 1 Day 15), Cycle 2 Day 15 and End of therapy (EOT)|The Biomarker Analysis Set included participants receiving at least one dose of treatment, with a Cycle 1 Day 1 biomarker result for at least one biomarker.||Ratio||Standard Deviation|Mean
785270|NCT00835978|Secondary|Comparison of Circulating Endothelial Cells (CECs) in Blood: Cluster of Differentiation (CD)146+/CD105+ at Baseline|CECs are noninvasive marker of vascular damage, remodeling, and dysfunction. Samples were collected and following proteins were analyzed: CD146+/CD105+ CECs, CD146+/CD105+ mean fluorescence intensity (MFI) platelet derived growth factor receptor (PDGFR)-beta, CD146+/CD105+ MFI phospho-PDGFR (pPDGFR)-beta, CD146+/CD105+ phospho-Vascular endothelial growth factor receptor (pVEGFR), CD146+/CD105+ MFI VEGFR. The ratio of plasma levels of the biomarkers at the selected time point vs baseline is reported.|At baseline - Beginning of the lead-in period (Cycle 1 Day 1)|The Biomarker Analysis Set included participants receiving at least one dose of treatment, with a Cycle 1 Day 1 biomarker result for at least one biomarker.||Fluorescent Intensity Unit (FIU)||Standard Deviation|Mean
785271|NCT00835978|Secondary|Change From Baseline in Diastolic Blood Pressure|Value at respective visit minus value at baseline.|At screening (D-14 to D-1); lead-in period: Cycle 1 - Day 1 and Day 15; Cycle 2 - Day 1 and Day 15; Cycle 3 & subsequent cycles Day 1; end of study and follow-up 28 days after last dose.|The SA population consists of all participatns who received at least one dose of study medication.||mmHg||Standard Deviation|Mean
785272|NCT00835978|Secondary|Change From Baseline in Systolic Blood Pressure|Value at respective visit minus value at baseline|At screening (D-14 to D-1); lead-in period: Cycle 1 - Day 1 and Day 15; Cycle 2 - Day 1 and Day 15; Cycle 3 & subsequent cycles Day 1; end of study and follow-up 28 days after last dose.|The SA population consists of all participatns who received at least one dose of study medication.||mmHg||Standard Deviation|Mean
785302|NCT00836095|Primary|Insertion Time|The insertion time will be the measured time that it takes the anesthesiologist to insert the airway and verify ventilation of the patient's airway. Data reported will be time in seconds ± the standard deviation.|During intubation of the patient|||seconds||Standard Deviation|Mean
785361|NCT00825734|Secondary|Objective Response Rate|Objective Response will be evaluated in this study using the Response Evaluation Criteria in Solid Tumors (RECIST).|every 9 weeks until discontinuation of treatment|Includes patients treated at the Phase II dose who were evaluable for response||patients|||Number
785273|NCT00835978|Secondary|Apparent Volume of Distribution During the Elimination Phase (Vz/F) for Axitinib|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vz/F is influenced by the fraction absorbed. Vz/F for steady-state axitinb was evaluated on Cycle 2 Day 15.|C2D15: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose|The pharmacokinetic (PK) population included all participants who were treated and had at least 1 concentration on 1 PK assessment day. The PK parameter analysis data set included all participants treated who had at least 1 estimated PK parameter of primary interest.||L||95% Confidence Interval|Geometric Mean
785274|NCT00835978|Secondary|Apparent Oral Clearance (CL/F) of Axitinib|Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed (F). Clearance is defined as the volume of blood from which drug can be completely removed per unit of time. CL/F for steady-state axitinib was evaluated on Cycle 2 Day 15.|C2D15: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose|The pharmacokinetic (PK) population included all participants who were treated and had at least 1 concentration on 1 PK assessment day. The PK parameter analysis data set included all participants treated who had at least 1 estimated PK parameter of primary interest.||L/hr||95% Confidence Interval|Geometric Mean
785275|NCT00835978|Secondary|Plasma Decay Half-Life (t1/2) for Axitinib|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Plasma decay half life for steady-state axitinib was evaluated on Cycle 2 Day 15.|C2D15: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose|The pharmacokinetic (PK) population included all participants who were treated and had at least 1 concentration on 1 PK assessment day. The PK parameter analysis data set included all participants treated who had at least 1 estimated PK parameter of primary interest.||hr||Standard Deviation|Mean
785276|NCT00835978|Secondary|Area Under the Curve From Time Zero to 24 Hours[AUC(0-24)] for Axitinib|Area under the plasma concentration time-curve from zero 24 hours[AUC(0-24). AUC(0-24) for steady-state axitinib was evaluated on Cycle 2 Day 15. Results were normalized to axitinib 7 mg dose for active titration arm and axitinib 5 mg dose for placebo titration arm.|C2D15: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose|The pharmacokinetic (PK) population included all participants who were treated and had at least 1 concentration on 1 PK assessment day. The PK parameter analysis data set included all participants treated who had at least 1 estimated PK parameter of primary interest.||ng.hr/mL||95% Confidence Interval|Geometric Mean
785277|NCT00835978|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Axitinib|Area under the plasma concentration time-curve from zero to the last measurable concentration (AUClast). AUClast for steady-state axitinib was evaluated on Cycle 2 Day 15. Results were normalized to axitinib 7 mg dose for active titration arm and axitinib 5 mg dose for placebo titration arm.|C2D15: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose|The pharmacokinetic (PK) population included all participants who were treated and had at least 1 concentration on 1 PK assessment day. The PK parameter analysis data set included all participants treated who had at least 1 estimated PK parameter of primary interest.||ng.hr/mL||95% Confidence Interval|Geometric Mean
785278|NCT00835978|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) for Axitinib,|Tmax for steady-state axitinib was evaluated on Cycle 2 Day 15.|C2D15: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose|The pharmacokinetic (PK) population included all participants who were treated and had at least 1 concentration on 1 PK assessment day. The PK parameter analysis data set included all participants treated who had at least 1 estimated PK parameter of primary interest.||hrs||Full Range|Median
785279|NCT00835978|Secondary|Maximum Observed Plasma Concentration (Cmax) of Axitinib|Cmax for steady-state axitinib was evaluated on Cycle 2 Day 15. Results were normalized to axitinib 7 mg dose for active titration arm and axitinib 5 mg dose for placebo titration arm. Results were normalized to axitinib 7 mg dose for active titration arm and axitinib 5 mg dose for placebo titration arm.|Cycle 2 Day 15 (C2D15): pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose|The pharmacokinetic (PK) population included all participants who were treated and had at least 1 concentration on 1 PK assessment day. The PK parameter analysis data set included all participants treated who had at least 1 estimated PK parameter of primary interest.||ng/mL||95% Confidence Interval|Geometric Mean
785280|NCT00835978|Secondary|Overall Survival (OS)|OS was defined as the time from date of the first dose of the study medication to date of death due to any cause. For participants who did not die, their survival times were to be censored at the last date they were known to be alive.|Baseline up to disease progression, death, or withdrawal; performed at baseline and repeated every 8 weeks for 24 weeks, then every 12 weeks.|The Full Analysis (FA) population included all randomized participants who received study drug or different drug to which they were randomized. The Safety Analysis (SA) population included all non-randomized patients who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.||Months||95% Confidence Interval|Median
785281|NCT00835978|Secondary|Duration of Response (DR)|DR was defined as the time from the first documentation of objective tumor response (complete response - CR or Partial response - PR) to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first. The median values were estimated based on Kaplan-Meier method. 95% confidence interval was based on the Brookmeyer and Crowley method.|Baseline up to disease progression, death, or withdrawal; performed at baseline and repeated every 8 weeks for 24 weeks, then every 12 weeks|Subset of Full Analysis (FA) and Safety Analysis (SA) patients who achieved confirmed complete or partial response. FA included all randomized patients and was based on randomized treatment assignment regardless of whether or not study drug was administered. SA included all non randomized patients who received at least one dose of study medication.||Months||95% Confidence Interval|Median
785282|NCT00835978|Secondary|Progression-Free Survival (PFS)|The time from first dose administration to first documentation of objective tumor progression or to death due to any cause. PFS in each arm was assessed using the Kaplan-Meier method and estimates of the PFS curves from the Kaplan-Meier method were presented.|Baseline up to disease progression, death, or withdrawal; performed at baseline and repeated every 8 weeks for 24 weeks, then every 12 weeks.|The Full Analysis (FA) population included all randomized participants who received study drug or different drug to which they were randomized. The Safety Analysis (SA) population included all non-randomized patients who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.||Months||95% Confidence Interval|Median
785283|NCT00835978|Primary|Objective Response Rate (ORR) - Percentage of Participants With Objective Response|ORR was defined as the proportion of participants with objective response based assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR was defined as complete disappearance of all target lesions and non-target disease. No new lesions. PR was defined as >=30% decrease on study under baseline of the sum of longest diameters of all target lesions. No unequivocal progression of non-target disease. No new lesions.|Baseline up to disease progression, death, or withdrawal; performed at baseline and repeated every 8 weeks for 24 weeks, then every 12 weeks.|The Full Analysis (FA) population included all randomized participants who received study drug or different drug to which they were randomized. The Safety Analysis (SA) population included all non-randomized patients who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.||Percentage of Participants||95% Confidence Interval|Number
785284|NCT00835991|Primary|AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)] - Metformin|Bioequivalence based on AUC0-t|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
785285|NCT00835991|Primary|AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Metformin|Bioequivalence based on AUC0-inf|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
785286|NCT00835991|Primary|Cmax (Maximum Observed Concentration) - Metformin|Bioequivalence based on Cmax|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
785287|NCT00835991|Primary|AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)] - Glyburide|Bioequivalence based on AUC0-t|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
785288|NCT00835991|Primary|AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Glyburide|Bioequivalence based on AUC0-inf|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
785289|NCT00835991|Primary|Cmax (Maximum Observed Concentration) - Glyburide|Bioequivalence based on Cmax|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
785290|NCT00836004|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
785291|NCT00836004|Primary|AUCinf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUCinf|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
785292|NCT00836004|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
785293|NCT00836017|Secondary|Pain Numeric Rating Scale Score|Patients rated their level of pain during the past 24 hours using an 11-point scale where: 0=no pain to 10= pain as bad as you can imagine. A lower number score indicated a lower amount of pain.|Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks)|Participants with data available for this outcome measure at all visits.||score on a scale||Standard Deviation|Mean
785294|NCT00836017|Secondary|Percentage of Participants With Improvement in the Patient Global Impression of Change|The patient evaluated the change in their present condition compared to Baseline using a 7-point scale where: 1= very much improved to 7= very much worse. The percentage of participants with responses: 1=very much improved, 2=much improved or 3=minimally improved is reported.|Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks)|Participants with data available for this outcome measure at all visits.||percentage of participants|||Number
785295|NCT00836017|Secondary|Percentage of Participants With Improvement in Clinicians Global Impression of Change|The physician evaluated the change in the patient’s present condition compared to Baseline using a 7-point scale where: 1= very much improved to 7= very much worse. The percentage of participants where the physician's response was: 1=very much improved, 2=much improved or 3=minimally improved is reported.|Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks)|All participants with data available for this outcome measure at all visits.||percentage of participants|||Number
785296|NCT00836017|Secondary|Percentage of Participants With Cervical Dystonia (CD) Severity Mild|The physician assessed the patient’s severity of CD using a 3-point scale: mild, moderate or severe. The percentage of participants with CD Severity Mild is reported.|Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks)|All participants with data available for this outcome measure at all visits.||percentage of participants|||Number
785297|NCT00836017|Primary|Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score|TWSTRS is an assessment scale used to measure the impact of cervical dystonia on patients. The score is comprised of 3 subscales: Severity, Disability, and Pain, each of which is scored independently. The total of these 3 subscales comprises the TWSTRS total score which is scored from 0 (least symptoms) to 85 (worst symptoms). Higher scores indicate a greater degree of symptom severity.|4-6 weeks after treatment 3 (Up to 104.3 weeks)|All participants with data available for this outcome measure at all visits.||score on a scale||Standard Deviation|Mean
785298|NCT00836056|Primary|Bioequivalence Based on AUC0-t|AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
785299|NCT00836056|Primary|Bioequivalence Based on AUCinf|AUCinf - Area under the concentration-time curve from time zero to infinity (extrapolated)|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
785300|NCT00836056|Primary|Bioequivalence Based on Cmax|Cmax - Maximum Observed Concentration|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
785303|NCT00824850|Primary|Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4)|Percentage of participants achieving predefined OPA antibody titer ≥1:8 for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A) along with the exact, 2-sided 95% CIs based on the observed percentage of participants. The lowest titer that can be determined using the standard OPA assay is a titer of 1:8 limit of detection (LOD) and is the same for each serotype-specific OPA assay.|Day 7 (Visit 4)|Evaluable Immunogenicity population; N=number of participants with a determinate OPA antibody titer to the serotypes.||observed percentage of participants||95% Confidence Interval|Number
785304|NCT00824850|Primary|Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)|Percentage of participants achieving predefined OPA antibody titer ≥1:8 for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A) along with the exact, 2-sided 95% CIs based on the observed percentage of participants. The lowest titer that can be determined using the standard OPA assay is a titer of 1:8 limit of detection (LOD) and is the same for each serotype-specific OPA assay.|Day 28 (Visit 5)|Evaluable Immunogenicity population; N=number of participants with a determinate OPA antibody titer to the serotypes.||observed percentage of participants||95% Confidence Interval|Number
785305|NCT00824850|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 4 Days After Vaccination|Systemic events reported using the diary card during the 4-day reactogenicity period after vaccination. Temperature scaled as Fever ≥38 but ≤39 degrees Celsius (C) (mild), >39 but ≤40 degrees C (moderate), or >40 degrees C (severe). Presence of Decreased appetite, Irritability, Increased sleep, Decreased sleep, Rash, and Hives; also scaled as Mild (easily tolerated, minimal discomfort; not interfering with activities), Moderate (sufficiently discomforting to interfere with normal activities), or Severe (may prevent normal activities and require medical intervention).|Baseline up to 4 days after vaccination on Day 1|Safety population; N=number of participants with analyzable data for reactogenicity events (reported Yes for at least 1 day or No for all days).||percentage of participants|||Number
785306|NCT00824850|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 4 Days After Vaccination|Local reactions reported using the diary card during the 4-day reactogenicity period after vaccination. Tenderness at injection site scaled as Any (tenderness present) or Significant (present and interfered with limb movement). Redness and swelling at injection site scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); or Severe (> 7.0 cm). Participants may be represented in >1 category.|Baseline up to 4 days after vaccination on Day 1|Safety population included all participants who received the vaccine. N=number of participants with analyzable data for reactogenicity events (reported Yes for at least 1 day or No for all days).||percentage of participants|||Number
785307|NCT00824850|Secondary|Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4)|Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMTs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Day 7 (Visit 4)|Evaluable Immunogenicity population; GMTs were calculated using all participants with available data for the specified blood draw. N=number of participants with a determinate OPA antibody titer for the serotypes.||Titer||95% Confidence Interval|Geometric Mean
785308|NCT00824850|Secondary|Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5)|Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMTs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Day 28 (Visit 5)|Evaluable Immunogenicity population; GMTs were calculated using all participants with available data for the specified blood draw. N=number of participants with a determinate OPA antibody titer for the serotypes.||Titer||95% Confidence Interval|Geometric Mean
785309|NCT00824850|Secondary|Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4)|Pneumococcal IgG GMCs measured as Mcg/mL for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMCs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Day 7 (Visit 4)|Evaluable Immunogenicity population; GMCs were calculated using all participants with available data for the specified blood draw. N=number of participants with a determinate OPA antibody concentration for the serotypes.||Mcg/mL||95% Confidence Interval|Geometric Mean
785310|NCT00824850|Secondary|Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5)|Pneumococcal IgG GMCs measured as Mcg/mL for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMCs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Day 28 (Visit 5)|Evaluable Immunogenicity population; GMCs were calculated using all participants with available data for the specified blood draw. N=number of participants with a determinate OPA antibody concentration for the serotypes.||Mcg/mL||95% Confidence Interval|Geometric Mean
785330|NCT00825162|Secondary|Frequency and Intensity of Unsolicited Adverse Events (UAEs)|UAE stands for Unsolicited Adverse Event.|30 days after each study vaccination|The Safety Population comprised all participants who received CSL's IVV and provided at least one safety assessment after vaccination.||Participants|||Number
785348|NCT00825344|Primary|Numerical Rating Scale Pain Score|0-10 pain score through 24-hours post-surgery. 0 is no pain and 10 is the worse pain imaginable. The primary outcome reported measure is the average of 4 scores, each comprised of 6-hour time intervals during the 24hour period.|24 hours|||units on a scale||Standard Deviation|Mean
785311|NCT00824850|Secondary|Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4|Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMTs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Baseline (Visit 1), Day 7 (Visit 4)|Evaluable Immunogenicity population; GMTs calculated using all participants with available data at both the prevaccination and postvaccination blood draws. N=number of participants with valid and determinate assay results for both the prevaccination and postvaccination blood draw.||Titer||95% Confidence Interval|Geometric Mean
785312|NCT00824850|Secondary|Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4|Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMTs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Baseline (Visit 1), Day 7 (Visit 4)|Evaluable Immunogenicity population; GMTs calculated using all participants with available data at both the prevaccination and postvaccination blood draws. N=number of participants with valid and determinate assay results for both the prevaccination and postvaccination blood draw.||Titer||95% Confidence Interval|Geometric Mean
785313|NCT00824850|Secondary|Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5|Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMTs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Baseline (Visit 1), Day 28 (Visit 5)|Evaluable Immunogenicity population; GMTs calculated using all participants with available data at both the prevaccination and postvaccination blood draws. N=number of participants with valid and determinate assay results for both the prevaccination and postvaccination blood draw.||Titer||95% Confidence Interval|Geometric Mean
785314|NCT00824850|Secondary|Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5|Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMTs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Baseline (Visit 1), Day 28 (Visit 5)|Evaluable Immunogenicity population; GMTs calculated using all participants with available data at both the prevaccination and postvaccination blood draws.||Titer||95% Confidence Interval|Geometric Mean
785315|NCT00824850|Secondary|Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4|Pneumococcal IgG GMCs measured as Mcg/mL for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMCs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Baseline (Visit 1), Day 7 (Visit 4)|Evaluable Immunogenicity population; GMCs calculated using all participants with available data at both the prevaccination and postvaccination blood draws. N=number of participants with valid and determinate assay results for both the prevaccination and postvaccination blood draw.||Mcg/mL||95% Confidence Interval|Geometric Mean
785316|NCT00824850|Secondary|Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4|Pneumococcal IgG GMCs measured as Mcg/mL for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMCs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Baseline (Visit 1), Day 7 (Visit 4)|Evaluable Immunogenicity population; GMCs calculated using all participants with available data at both the prevaccination and postvaccination blood draws.||Mcg/mL||95% Confidence Interval|Geometric Mean
785317|NCT00824850|Secondary|Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5|Pneumococcal IgG GMCs measured as Mcg/mL for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMCs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Baseline (Visit 1), Day 28 (Visit 5)|Evaluable Immunogenicity population; GMCs calculated using all participants with available data at both the prevaccination and postvaccination blood draws.||Mcg/mL||95% Confidence Interval|Geometric Mean
785318|NCT00824850|Secondary|Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5|Pneumococcal IgG GMCs measured as Mcg/mL for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMCs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Baseline (Visit 1), Day 28 (Visit 5)|Evaluable Immunogenicity population. GMCs calculated using all participants with available data at both the prevaccination and postvaccination blood draws.||Mcg/mL||95% Confidence Interval|Geometric Mean
785345|NCT00825318|Primary|Mean Arterial Blood Pressure||Prestudy Phase (retrospective analysis, 3 months), Daily Ultrafiltration Phase (4 weeks), Return Phase (4 weeks)|||mm Hg||Full Range|Mean
785346|NCT00825344|Secondary|Chronic Post-surgical Pain|Patients with persistent post-surgical pain|Up to 12 months|||participants|||Number
785347|NCT00825344|Secondary|Analgesic Usage|Number of oxycodone/ acetaminophen tablets consumed through 24 hours post-surgery|24 hours|||tablets||Standard Deviation|Mean
785319|NCT00824850|Primary|Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4)|Percentage of participants achieving predefined OPA antibody titer ≥ serotype-specific lower limit of quantification (LLOQ) using modified microcolony assays for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A) along with the exact, 2-sided 95% CIs based on the observed percentage of participants. LLOQ for each serotype: 1=1:8, 3=1:12, 4=1:21, 5=1:29, 6A=1:37, 6B=1:43, 7F=1:210, 9V=1:345, 14=1:35, 18C=1:31, 19A=1:18, 19F=1:48, 23F=1:13.|Day 7 (Visit 4)|Evaluable Immunogenicity population; N=number of participants with a determinate OPA antibody titer to the serotypes.||observed percentage of participants||95% Confidence Interval|Number
785320|NCT00824850|Primary|Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)|Percentage of participants achieving predefined OPA antibody titer ≥ serotype-specific lower limit of quantification (LLOQ) using modified microcolony assays for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A) along with the exact, 2-sided 95% CIs based on the observed percentage of participants. LLOQ for each serotype: 1=1:8, 3=1:12, 4=1:21, 5=1:29, 6A=1:37, 6B=1:43, 7F=1:210, 9V=1:345, 14=1:35, 18C=1:31, 19A=1:18, 19F=1:48, 23F=1:13.|Day 28 (Visit 5)|Evaluable Immunogenicity population; N=number of participants with a determinate OPA antibody titer to the serotypes.||observed percentage of participants||95% Confidence Interval|Number
785321|NCT00824850|Primary|Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4)|Percentage of participants achieving predefined IgG antibody threshold ≥0.35 Mcg/mL for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A) along with the exact, 2-sided 95% CIs based on the observed percentage of participants.|Day 7 (Visit 4)|Evaluable Immunogenicity population; N=number of participants with a determinate IgG antibody concentration for the serotypes.||observed percentage of participants||95% Confidence Interval|Number
785322|NCT00824850|Primary|Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)|Percentage of participants achieving predefined IgG antibody threshold ≥0.35 micrograms per milliliter (Mcg/mL) for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A) along with the exact, 2-sided 95% confidence intervals (CIs) based on the observed percentage of participants.|Day 28 (Visit 5)|Evaluable Immunogenicity population: eligible participants based on all inclusion and exclusion criteria, had a baseline blood sample collection performed (Visit 1), received 1 dose of 13vPnC, and had Visit 5 blood sample collection performed, and at least 1 valid and determinate assay result at Visit 1 and also at Visit 5.||observed percentage of participants||95% Confidence Interval|Number
785323|NCT00825162|Secondary|Frequency of New Onsets of Chronic Illness||180 days after the last study vaccination|The Safety Population comprised all participants who received CSL's IVV and provided at least one safety assessment after vaccination.||Participants|||Number
785324|NCT00825162|Secondary|Frequency of Serious Adverse Events||180 days after the last study vaccination|The Safety Population comprised all participants who received CSL's IVV and provided at least one safety assessment after vaccination.||Participants|||Number
785325|NCT00825162|Primary|Duration of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years)|Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, and malaise.|7 days post-vaccination|The Safety Population comprised all participants who received CSL’s IVV at Visit 1 and provided at least one safety assessment after vaccination. For the safety analysis of solicited AEs after the second vaccination, only those participants who received a second vaccination and provided safety follow-up after the second vaccination were included.||Days||Standard Deviation|Mean
785326|NCT00825162|Primary|Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years)|Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, and malaise.|7 days post-vaccination|The Safety Population comprised all participants who received CSL’s IVV at Visit 1 and provided at least one safety assessment after vaccination. For the safety analysis of solicited AEs after the second vaccination, only those participants who received a second vaccination and provided safety follow-up after the second vaccination were included.||Participants|||Number
785327|NCT00825162|Primary|Duration of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years)|Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, and malaise.|7 days post-vaccination|The Safety Population comprised all participants who received CSL’s IVV at Visit 1 and provided at least one safety assessment after vaccination. For the safety analysis of solicited AEs after the second vaccination, only those participants who received a second vaccination and provided safety follow-up after the second vaccination were included.||Days||Standard Deviation|Mean
785328|NCT00825162|Primary|Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years)|Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, and malaise.|7 days post-vaccination|The Safety Population comprised all participants who received CSL’s IVV and provided at least one safety assessment after vaccination. For the safety analysis of solicited AEs after the second vaccination, only those participants who received a second vaccination and provided safety follow-up after the second vaccination were included.||Participants|||Number
785329|NCT00825162|Primary|Duration of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years)|Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, loss of appetite, and irritability.|7 days post-vaccination|The Safety Population comprised all participants who received CSL’s IVV and provided at least one safety assessment after vaccination. For the safety analysis of solicited AEs after the second vaccination, only those participants who received a second vaccination and provided safety follow-up after the second vaccination were included.||Days||Standard Deviation|Mean
785331|NCT00825162|Primary|Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years)|Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, loss of appetite, and irritability.|7 days post-vaccination|The Safety Population comprised all participants who received CSL’s IVV and provided at least one safety assessment after vaccination. For the safety analysis of solicited AEs after the second vaccination, only those participants who received a second vaccination and provided safety follow-up after the second vaccination were included.||Participants|||Number
785332|NCT00825175|Primary|Time Performing Upright Play Skills|20 minute session of playing in upright. This is video recorded and behavior coded|bi-monthly; starting when child can pull to stand and ending at walking onset||||||
785333|NCT00825175|Primary|Gait Parameters||1 month after walking onset||||||
785334|NCT00825175|Primary|Pattern of Gross Motor Development|Age in months at walking development as indicated by the Gross Motor Function Measure, a standardized test of gross motor development.|monthly; starting when child can pull to stand and ending when the test determined that the child was walking.|analysis was on protocol||months||Standard Deviation|Mean
785335|NCT00825227|Secondary|Change in the Brief Fatigue Inventory (BFI) Global Score|The Brief Fatigue Inventory (BFI) measures severity of fatigue and impact of fatigue on daily functioning in past 24 hours. It is a 9-item questionnaire that uses an 11-point scale (0-10) to assess severity. Question 3 asks for worst level of fatigue during past 24-hours. 0 represents no fatigue, 10 represents as bad as you can imagine. The global score (0 to 90) determined by adding each item was to be assessed. Study was terminated as a result of a business decision after only a few patients were enrolled and therefore efficacy results were not analyzed and are not reported.|Duration of up to 8 weeks total (Screening and Double-Blind)||||||
785336|NCT00825227|Secondary|Percentage of Days With Severe Fatigue, From Patient Responses to the Brief Fatigue Inventory (BFI) Assessment Questionnaire|The Brief Fatigue Inventory (BFI) measures severity of fatigue and impact of fatigue on daily functioning in past 24 hours. It is a 9-item questionnaire that uses an 11-point scale (0-10) to assess severity. 0 represents no fatigue, 10 represents as bad as you can imagine. The percentage of days with severe fatigue as assessed by the BFI was to be assessed. Study was terminated as a result of a business decision after only a few patients were enrolled and therefore efficacy results were not analyzed and are not reported.|Duration of up to 8 weeks total (Screening and Double-Blind)||||||
785337|NCT00825227|Primary|Change Over Time in the Patient's Daily Ratings of Their Worst Fatigue Severity (as Assessed for the Past 24 Hours), Obtained From the Patient's Responses on the Brief Fatigue Inventory (BFI) Questionnaire|Brief Fatigue Inventory (BFI) measures fatigue severity and impact on function on 11-point scale (0-10). Primary outcome measure is average daily rating of BFI question 3: worst level of fatigue over past 24-hours. 0 = no fatigue, 10 = worst imaginable. Study was terminated after only a few patients enrolled and therefore efficacy results were not analyzed and are not reported. Maximum response (most fatigue) would score 10 and minimum response (least fatigue) would score 0. Change was measured from Baseline (cycle 1) to cycle 2. Changes based on matching baseline period with cycle 2 period.|Recorded once daily by the Patient, for up to 8 weeks total (Screening and Double-Blind)|Study was discontinued after only 6 subjects were enrolled due to a business decision, so no outcome analysis was done.||units on a scale||Standard Deviation|Mean
785338|NCT00825266|Secondary|NYHA (New York Heart Association Classification) Changes|"New York Heart Classification(NYHA) changes measured at 16 weeks compared with baseline.
NYHA Classification:
NYHA class I:no symptoms and no limitation in ordinary physical activity NYHA class II:Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity NYHA class III:Marked limitation in activity due to symptoms, even during less-than-ordinary activity, NYHA class IV:Severe limitations. Experiences symptoms even while at rest. {Higher NYHA class represent worse symptoms}"|Baseline and 16 weeks|||NYHA class|||Number
785339|NCT00825266|Secondary|6 Minute Walk Test|6 minute walk test measures the distance that a patient can walk on a flat, hard surface in a period of 6 minutes.It assess the disease severity of the subject at 16 week compared to the baseline.|Baseline and 16 weeks|||meters|||Number
785340|NCT00825266|Primary|Insulin Resistance Profile Change - Triglyceride:HDL Cholesterol Ratio|insulin resistance measured -triglyceride: HDL cholesterol ratio measures at 16 weeks compared with baseline.|baseline and 16 weeks|||ratio|||Number
785341|NCT00825305|Secondary|Percentages of Participants With Seroconversion (Rabies Virus Neutralizing Antibody Concentrations Equal and Above 0.5 IU/ml) on Days 7, 14 and 42.|Percentages of participants with seroconversion (defined as rabies virus neutralizing antibody concentrations equal and above 0.5 IU/ml) on days 7, 14 and 42.|7 days, 14 days and 42 days|Due to the Chinese registration requirements, only a subset of subjects bloodsamples were drawn and immunogenicity was evaluated. The per protocol population of this subset was analyzed.||percentages of participants||95% Confidence Interval|Mean
785342|NCT00825305|Primary|Number of Participants Who Reported a Local or Systemic Reaction After Any Vaccination|Specified local and systemic reactions were solicited for 7 days after each vaccination. Number of participants were calculated who reported a local or systemic reaction after any of the vaccinations.|7 days after each vaccination|Safety was analyzed for the safety set. One enrolled subject was not vaccinated and not included in the safety set because of inappropriate inclusion.||participants|||Number
785343|NCT00825305|Secondary|Rabies Virus Neutralizing Antibody Concentrations on Day 7 and Day 42.|Rabies virus neutralizing antibody concentrations the abbreviated Zagreb regimen compared with the conventional Essen regimen. Results are presented on log2 scale. For results on original geometric (multiplicative) scale please raise numbers to the basis of 2.|7 days and 42 days|Due to the Chinese registration requirements, only a subset of subjects bloodsamples were drawn and immunogenicity was evaluated. The per protocol population of this subset was analyzed.||IU/ml||95% Confidence Interval|Log Mean
785344|NCT00825305|Primary|Rabies Virus Neutralizing Antibody Concentrations on Day 14.|Rabies virus neutralizing antibody concentrations of the abbreviated Zagreb regimen compared with the conventional Essen regimen. Results are presented on log2 scale. For results on original geometric (multiplicative) scale please raise numbers to the basis of 2.|14 days|Due to the Chinese registration requirements, only a subset of subjects bloodsamples were drawn and immunogenicity was evaluated. The per protocol population of this subset was analyzed.||IU/mL||95% Confidence Interval|Log Mean
785349|NCT00825500|Secondary|Photophobia Free|Free of Photophobia at 2 Hours Post-treatment|2 hours|ITT with LOCF Population||Participants|||Count of Participants
785351|NCT00825565|Primary|Physician Assessment of Individual Signs|"In addition to skin blistering and erosions, people with EB experience other symptoms, such as erythema on unblistered skin, wound oozing, weeping, and crusting. These symptoms may vary with area of the body evaluated.
This scale evaluates the following signs: Blistering and erosions, oozing/weeping/crusting, pruritis, erythema on unblistered surrounding skin, pain, milia Each of these signs will be scored in 4 body areas: head/neck, upper limbs, trunk, lower limbs The following scale is used:0 = clear 1 = almost clear 2 = mild 3 = moderate 4 = severe"|baseline and then every 4 weeks for a total of 12 weeks||||||
785352|NCT00825565|Primary|Physician Global Assessment of Severity (PGAS)|"The FDA has suggested that a global measure of severity might be the best way to assess EB from visit to visit. Assessment score may be influenced by other clinical observations in addition to the percentage of body affected by blistering and erosions. The assessment was intended to be a global impression.
This scale produced a score with the following correlations:
0 = clear (no blistering/erosions) 1-2 = almost clear (infrequent blistering and erosions) 3-4 = mild disease (up to 15% of body affected) 5-6 = moderate disease (between 16-25% of body affected) 7-8 = severe disease (between 26-50% of body affected) 9-10 = very severe disease (greater than 50% of body affected)"|baseline and then every 4 weeks for a total of 12 weeks||||||
785353|NCT00825565|Primary|Target Wound Size Reduction or Closure|"EB patients may have chronic wounds which are resistant to healing. Wound size may be very large and the probability of total wound closure with currently available treatments is unlikely. Reduction in the size of wounds may be clinically important to the rate of infection and pain. If a patient has a reduction in the size of wounds which are refractory to healing, this may be seen as a positive outcome. Wound size reduction is one of the primary assessments used to determine the efficacy of the study cream.
Wounds which had been present for at least several weeks prior to study entry were measured by using VISITRAK Digital, a Smith and Nephew wound tracing and measurement system that will calculate the length and width of the lesion (class 1 medical device; FDA listing designation E142354FDA). Only one target lesion per patient was used for the study assessment. At each subsequent study until the final visit, the target lesion was evaluated using VISITRAK Digital."|baseline and then every 4 weeks for a total of 12 weeks|Subjects who used allantoin 3% cream on the target wound daily up to full closure of that wound were included in the analysis.||number of unhealed target wounds|||Number
785354|NCT00825565|Primary|Blister/Erosion Reduction Based on Change in Body Surface Area (BSA) Coverage|"A common measure of the degree of involvement in skin disease is the Body Surface Area Index (BSAI). This measure is also commonly used in psoriasis studies. It is a global measure of disease spread with weighting factors."|baseline and then every 4 weeks for a total of 12 weeks|Subjects who used allantoin 3% cream for an entire month prior to the BSA monthly assessment were included in the analysis.||percentage of BSA involvement||Standard Deviation|Mean
785355|NCT00825630|Primary|Urea Breath Test Result (DOB > 5 is Positive)After Different Time Periods From When PPI (Proton Pump Inhibitor) Was Stopped.|Negative value is defined as delta over baseline (DOB) less than 5. The subjects who were positive (DOB>=5) for H.Pylori and after PPI for 10 days repeated a breath with a negative (DOB<5) were considered false negatives. The breath test has been cleared by the FDA in a 510(k) and has > 96% accuracy.|17 days|Analysis was done on an ITT basis and approximately 25 subjects per group were anticipated in order to obtain a general evaluation of which PPI is will cause the least amount of false negatives.The actual amount of subjects in each group will depend upon the availability of the different PPIs through the course of the study.||participants|||Number
785356|NCT00825682|Secondary|The General Sleep Disturbance Scale (GSDS), Compiled by Lee (1992) and Translated Into Hebrew by Dr. Dorit Pud (2007)|"examines several aspects of sleep disorders and includes 21 items that describe feelings and behaviors associated with sleep during the last week. It uses a 0 (never) to 7 (every day) Likert scale on questions like feeling nervous during the day; falling asleep while unplanned and using sleeping pills.
A total sleep disturbance score was calculated as the average of all 21 items (ranging between 0 and 7), higher scores indicating a worse outcome."|Beginning of study (initiation of radiation therapy and reflexology), 5 weeks after start (end of radiation therapy), 10 weeks after start|The final analysis included 34 women in the experimental group and 20 in the control group.||Scores on a scale||Standard Deviation|Mean
785357|NCT00825682|Secondary|The Multidimensional Quality of Life Scale Cancer MQOLS-CA Was Written by Padilla (1992) and Translated Into Hebrew by Dorit Pud (2007).|"The questionnaire includes 33 items describing different forms in which the disease may affect patient's quality of life. For each item, subjects are asked to mark the number that best describes their feelings right now, in a Likert scale ranging between 0 and 10. Items include happiness feelings, anxiety levels, how affected are the social ties because of the disease, etc.
A total quality of life score was calculated as the average of all 33 items (ranging between 0 and 10), higher scores indicating a better quality of life."|Beginning of study (initiation of radiation therapy and reflexology), 5 weeks after start (end of radiation therapy), 10 weeks after start|The final ananlysis included 34 women in the experimental group, and 20 women in the control group.||Scores on a scale||Standard Deviation|Mean
785358|NCT00825682|Primary|The Lee Fatigue Scale|"The Lee Fatigue Scale consists of 18 items related to fatigue and energy: 13 items in the fatigue subscale and 5 items in the energy subscale. The mean of the 13 items in the fatigue subscale (range from 0-10) and the mean of the 5 items in the energy subscale (range from 0-10) are calculated. Higher scores indicate higher levels of perceived fatigue and energy . Items in the energy subscale were recoded, and a Lee fatigue total score was calculated as the average of all 18 items (ranging between 0 and 10), higher scores indicating higher levels of fatigue.
The Cronbach's Alpha reliability coefficient of the English version of the questionnaire is 0.77 . The questionnaire's validity and reliability have been established in cancer patients."|Beginning of study (initiation of radiation therapy and reflexology), 5 weeks after start (end of radiation therapy), 10 weeks after start|The final analysis included 33 women in the experimental group and 20 in the control group.||units on a scale||Standard Deviation|Mean
785359|NCT00825734|Secondary|Number of Patients With Adverse Events as a Measure of of Safety and Tolerability|Assessments are made through analysis of reported incidence of treatment-emergent AEs and SAEs.|every 9 weeks until treatment discontinuation or unacceptable toxicity|Patients treated at the Phase II dose||participants|||Number
785360|NCT00825734|Secondary|Overall Survival (OS)|Measured from Day 1 of study drug administration to date of death due to any cause.|every 9 weeks until treatment discontinuation or death on study|Includes patients treated at the Phase II dose||months||95% Confidence Interval|Median
785362|NCT00825734|Secondary|6-month Progression-Free Survival|Measured from Day 1 of study drug administration to disease progression as defined by RECIST v1.1, or death on study. Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|every 9 weeks, up to 6 months|Includes patients treated at the Phase II dose||percentage of participants|||Number
785363|NCT00825734|Primary|Progression-Free Survival (PFS)|Measured from Day 1 of study drug administration to disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) - progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|every 9 weeks until treatment discontinuation or death on study|Includes patients treated at the Phase II dose||months||95% Confidence Interval|Median
785364|NCT00825786|Secondary|Total Opioid Consumption|In morphine equivalent dose|postoperative day 1 to day 3|||mg||Inter-Quartile Range|Median
785365|NCT00825786|Secondary|Duration of Analgesia|Time from the complete onset of sensory block until first request for an analgesic|from surgery date to postoperative day 1|||hours||Inter-Quartile Range|Median
785366|NCT00825786|Secondary|Maximum Verbal Response Score (VRS) With Movement|The severity of postoperative pain was assessed by an observer blinded to treatment using a 0- to 10-point verbal response score (VRS): 0 = no pain and 10 = worst|through post operative day 3|||mm||Inter-Quartile Range|Median
785367|NCT00825786|Secondary|Maximum Verbal Response Score (VRS) With Rest|The severity of postoperative pain was assessed by an observer blinded to treatment using a 0- to 10-point verbal response score (VRS): 0 = no pain and 10= worst pain|through post operative day 3|||mm||Inter-Quartile Range|Median
785368|NCT00825786|Secondary|Time to Onset of First Sensory Block||during surgery|||minutes||Inter-Quartile Range|Median
785369|NCT00825786|Secondary|Time to Complete Motor Block||during surgery from induction time to end case time|||minutes||Inter-Quartile Range|Median
785370|NCT00825786|Primary|Duration of Analgesia.|The primary outcomes will be the onset time, onset of surgical block, and duration of analgesia.|During surgery: postoperative day 0|||minute||Inter-Quartile Range|Median
785371|NCT00825812|Secondary|Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.7 and 0.8.|Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade.|start of administration of sugammadex/neostigmine to recovery from neuromuscular blockade|The Full Analysis Set population included all subjects who received randomized treatment and had at least one efficacy measurement. In the event of missing data, imputed data were used for analysis.||minutes||95% Confidence Interval|Geometric Mean
785372|NCT00825812|Primary|Time From Start of Administration of Investigational Medicinal Product (IMP) to Recovery of the T4/T1 Ratio to 0.9.|"Neuromuscular functioning was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation was to continue until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached >= 0.9. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade, with a value of 1.0 representing full recovery.
The primary analysis was the comparison between sugammadex & neostigmine among Chinese subjects; other comparisons were secondary."|start of administration of sugammadex/neostigmine to recovery from neuromuscular blockade|"The Full Analysis Set (FAS) population included all subjects who received randomized treatment and had at least one efficacy measurement. In the event of missing data, imputed data were used for analysis.
291 subjects received IMP, of whom two had no efficacy measurements at all. Hence the FAS consisted of 289 subjects."||minutes||95% Confidence Interval|Geometric Mean
785373|NCT00825825|Secondary|Number of Voxels Showing Greater Activation Following Escitalopram Compared With Citalopram When Affective Words Are Contrasted With a Fixation Stimulus.|Activation was measured using BOLD fMRI in response to affective words contrasted with activation in response to a neutral fixation stimulus. The response following two weeks of escitalopram was compared to the response following two weeks of citalopram. The cluster of differential activation was located in the left primary visual cortex.|2 weeks|Participants were only included in the analysis if they had complete data for all 3 fMRI scans and motion was within acceptable limits. Participants also had to have detectable plasma levels of R-citalopram and S-citalopram in order to be included in the final analysis.||voxels|||Number
785374|NCT00825825|Secondary|Number of Voxels Showing Greater Activation Following Placebo Compared With Citalopram When Affective Words Are Contrasted With a Fixation Stimulus.|Activation was measured using BOLD fMRI in response to affective words contrasted with activation in response to a neutral fixation stimulus. The response following two weeks of placebo was compared to the response following two weeks of citalopram. The cluster of differential activation was located in the right lingual gyrus and right superior lateral occipital cortex.|2 weeks|Participants were only included in the analysis if they had complete data for all 3 fMRI scans and motion was within acceptable limits. Participants also had to have detectable plasma levels of R-citalopram and S-citalopram in order to be included in the final analysis.||voxels|||Number
785375|NCT00825825|Secondary|Number of Voxels Showing Greater Activation Following Escitalopram Compared With Placebo When Affective Faces Are Presented in a Covert Stimulus Presentation and Contrasted With a Fixation Stimulus.|Activation was measured using BOLD fMRI in response to affective (happy and fearful) faces presented in a covert or masked presentation and contrasted with activation in response to a neutral fixation stimulus. The response following two weeks of escitalopram was compared to the response following two weeks of placebo. The cluster of differential activation was located in the right inferior lateral occipital cortex.|2 weeks|Participants were only included in the analysis if they had complete data for all 3 fMRI scans and motion was within acceptable limits. Participants also had to have detectable plasma levels of R-citalopram and S-citalopram in order to be included in the final analysis.||voxels|||Number
785397|NCT00836277|Secondary|Overall Survival (OS)||Up to 45 months (cohort)|||months||95% Confidence Interval|Median
785398|NCT00836277|Secondary|Progression-free Survival (PFS)|Survival time the is free of disease progression. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Up to 45 months (cohort)|||months||95% Confidence Interval|Median
785376|NCT00825825|Secondary|Number of Voxels Showing Greater Activation Following Citalopram Compared With Placebo When Affective Faces Are Presented in a Covert Stimulus Presentation and Contrasted With a Fixation Stimulus.|Activation was measured using BOLD fMRI in response to affective (happy and fearful) faces presented in a covert or masked presentation and contrasted with activation in response to a neutral fixation stimulus. The response following two weeks of citalopram was compared to the response following two weeks of placebo. The cluster of differential activation was located in the right lateral occipital cortex.|2 weeks|Participants were only included in the analysis if they had complete data for all 3 fMRI scans and motion was within acceptable limits. Participants also had to have detectable plasma levels of R-citalopram and S-citalopram in order to be included in the final analysis.||voxels|||Number
785377|NCT00825825|Secondary|Number of Voxels Showing Greater Activation Following Citalopram Compared With Placebo When Affective Faces Are Presented in a Covert Stimulus Presentation and Contrasted With a Fixation Stimulus.|Activation was measured using BOLD fMRI in response to affective (happy and fearful) faces presented in a covert or masked presentation and contrasted with activation in response to a neutral fixation stimulus. The response following two weeks of citalopram was compared to the response following two weeks of placebo. The cluster of differential activation was located in the right occipital fusiform gyrus.|2 weeks|Participants were only included in the analysis if they had complete data for all 3 fMRI scans and motion was within acceptable limits. Participants also had to have detectable plasma levels of R-citalopram and S-citalopram in order to be included in the final analysis.||voxels|||Number
785378|NCT00825825|Secondary|Number of Voxels Showing Greater Activation Following Escitalopram Compared With Citalopram When Faces and a Fixation Stimulus Are Presented in an Overt Presentation.|Activation was measured using BOLD fMRI in response to affective faces and a fixation stimulus presented in an overt or unmasked presentation. The response following two weeks of escitalopram was compared to the response following two weeks of citalopram. The cluster of differential activation was located in the right insular cortex.|2 weeks|Participants were only included in the analysis if they had complete data for all 3 fMRI scans and motion was within acceptable limits. Participants also had to have detectable plasma levels of R-citalopram and S-citalopram in order to be included in the final analysis.||voxels|||Number
785379|NCT00825825|Primary|Number of Voxels Showing Greater Activation Following Escitalopram Compared With Citalopram When Happy and Fearful Faces Are Presented in a Rapid Covert Stimulus Presentation.|Activation was measured using BOLD fMRI in response to happy and fearful faces presented in a rapid covert or masked presentation. The response following two weeks of escitalopram was compared to the response following two weeks of citalopram. The cluster of differential activation was located in the left middle temporal gyrus.|two weeks|Participants were only included in the analysis if they had complete data for all 3 fMRI scans and motion was within acceptable limits. Participants also had to have detectable plasma levels of R-citalopram and S-citalopram in order to be included in the final analysis.||voxels|||Number
785380|NCT00825916|Secondary|Between-group Mean Differences in Objective Measures Obtained Via 3D Photography (Volume)|This secondary outcome included measurements based on 3D photography of the scar surface at Month 12 and included positive volume, negative volume, and total volume. All volume measurements were made relative to the interpolated smooth skin surface. A value closer to zero was preferred, because zero was equal to the normal skin surface. Positive volume was calculated as the volume of the scar above the interpolated smooth skin surface. Negative volume was calculated as the volume of the scar below the smooth interpolated skin surface, and was always a negative number. Total volume was calculated as the sum of positive volume and the absolute value of negative volume. Smaller values were more desirable.|12 months|In this early phase study, the efficacy and safety analyses were performed using an evaluable subject sample, which included all subjects who received study agent and provided some efficacy or safety data.||Millimeters cubed||Standard Deviation|Mean
785381|NCT00825916|Secondary|Between-group Mean Differences in Objective Measures Obtained Via 3D Photography (Elevation, Length, Width)|This secondary outcome included scar measurements based on 3D photography of the scar surface at Month 12 and included maximum length, maximum width perpendicular to maximum length, and minimum, maximum and mean elevation. All elevation measurements were made relative to the interpolated smooth skin surface. A value closest to zero was preferred because zero was equal to the normal skin surface. The minimum elevation value was calculated as the lowest point of the scar below the interpolated smooth skin surface and was always a negative number. A more negative number was worse because it indicated a deeper measurement below the interpolated smooth skin surface. The maximum elevation value was calculated as the highest point of the scar above the interpolated smooth skin surface. A larger number was worse because it indicated a higher peak above the interpolated smooth skin surface. The mean elevation of the scar relative to the interpolated smooth skin surface was also calculated.|12 months|In this early phase study, the efficacy and safety analyses were performed using an evaluable subject sample, which included all subjects who received study agent and provided some efficacy or safety data.||Millimeters||Standard Deviation|Mean
785382|NCT00825916|Secondary|Between-group Mean Differences in Visual Analog Scale (VAS) Scores by Independent Blinded Raters|At 12 months, two independent dermatologists who were blinded to study treatment evaluated the scar images using a Visual Analog Scale (VAS) of 0-100 millimeters (mm), with 0 being normal skin and 100 being the worst scar imaginable. The scars were presented in longitudinal (chronological) order. Efficacy was based on the difference between VAS scores of placebo and 3 mg AZX100, and placebo and 10 mg AZX100 for each of the two raters separately. Data from the two raters was not combined.|12 months|In this early phase study, the efficacy and safety analyses were performed using an evaluable subject sample, which included all subjects who received study agent and provided some efficacy or safety data.||Millimeters||Standard Deviation|Mean
785416|NCT00836472|Primary|Cmax (Maximum Observed Concentration) - Metformin|Bioequivalence based on Cmax|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
785417|NCT00836472|Primary|AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)] - Glyburide|Bioequivalence based on AUC0-t|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
785608|NCT00838682|Secondary|Surgery|"This sencodary endpoint surgery is the operation for bleeding control of peptic ulcer bleeding such as gastric or duodenal primary closure, and subtotal gastrectomy with/without vagotomy."|6wk|intention to treat (ITT)||participants|||Number
785383|NCT00825916|Primary|Differences Among the 3 Dosage Groups in the Patient (PSAS) and Observer (OSAS) Scar Assessment Scale (POSAS) Scores|Efficacy was based on the difference between mean POSAS scores of placebo, 3 mg AZX100, and 10 mg AZX100 12 months after surgery. This gave four comparisons to placebo: patient or observer and 3 mg and 10 mg AZX100. PSAS included patients' ratings on a scale of 1-10 (1 was normal skin or no complaints and 10 was the worst imaginable scar or the worst difference) for the following: Is the scar painful? Is the scar itching? Is the color of the scar different? Is the scar more stiff? Is the thickness of the scar different? Is the scar irregular? The possible minimum score was 6 and the maximum (worst) score was 60. OSAS included observers' ratings on a scale of 1-10 (1 was normal skin and 10 was the worst scar imaginable) for vascularization, pigmentation, thickness, relief, and pliability. The possible minimum score was 5 and the possible maximum (worst) score was 50.|12 Months|In this early phase study, the efficacy and safety analyses were performed using an evaluable subject sample, which included all subjects who received study agent and provided some efficacy or safety data.||Units on a scale||Standard Deviation|Mean
785384|NCT00825994|Secondary|Change in Hot Flash Daily Interference Scale (HFRDIS)|Vasomotor symptoms (hot flashes) were tracked by using a self-report Hot Flash Related Daily Interference Scale (HFRDIS). The HFRDIS is a 10-item self-report questionnaire in which subjects rate the degree to which hot flashes interfere with daily activities and quality-of-life during the prior week. Each item is rated on a scale from 0 (does not interfere) to 10 (completely interferes) for a total score range of 0-100 (higher score indicates greater symptom burden/interference).|8 weeks|Of 31 women who consented to participate per protocol 24 were eligible. Of these 24 eligible participants, three women withdrew and one was a placebo responder. 20 women started omega-3 fatty acid treatment and 19 completed the study. Of these 20, 15 women had hot flashes at baseline and could be included in the hot flash analysis.||units on a scale||Standard Deviation|Mean
785385|NCT00825994|Primary|Change in MADRS Score|"The instrument used to measure mood at each visit was the Montgomery-Åsberg Depression Rating Scale (MADRS).
The MADRS is a widely used 10-item clinician-rated scale that describes the severity of depressive symptoms (range 0-60, higher score indicates greater symptom burden)."|8 weeks|Of 31 women who consented to participate per protocol 24 were eligible. Of these 24 eligible participants, three women withdrew and one was a placebo responder. 20 women started omega-3 fatty acid treatment and 19 completed the study.||units on a scale||Standard Deviation|Mean
785386|NCT00826007|Primary|Hypoglycemia Incidence|Blood glucose values <70 mg/dl|perioperative period|||participants|||Number
785387|NCT00826111|Secondary|Change in Insomnia Severity Index Score From Baseline to Week 10|The Insomnia Severity Index is a 7 item scale that assesses difficulty sleeping and effect on quality of life with item scores from 0-4. The total score range is 0 to 28 with higher scores indicating higher levels of impairment and distress.|baseline and 10 weeks|||scores on a scale||Standard Deviation|Mean
785388|NCT00826111|Secondary|Change in Hamilton Anxiety Rating Scale Score From Baseline to Week 10|The Hamilton Anxiety Rating Scale is a 14 item ordinal scale that assesses symptoms of anxiety with ratings from 0-4. The score range is 0 to 56, with a higher score indicating higher levels of anxiety. A score of 15 was designated as the cut-off for enrollment in the study.|baseline and 10 weeks|Participants who completed 10 weeks and one participant who completed 6 weeks (using last observation carried forward) were included in this analysis.||scores on a scale||Standard Deviation|Mean
785389|NCT00826111|Secondary|Change in Hamilton Depression Rating Scale Score From Baseline to Week 10|The Hamilton Depression Rating Scale is a 21 item scale that assesses symptoms of depression with items rated on a scale of 0-4 or 0-2. The total score range is 0 to 65. A score of 7 or lower is generally considered to be an absence of depressive symptoms. A score of 18 was considered to be the cut-off for enrollment in this study, as this indicates clinically significant depression. A higher score represents greater severity of depressive symptoms.|baseline and 10 weeks|||scores on a scale||Standard Deviation|Mean
785390|NCT00826111|Secondary|Change in Thalamic GABA From Baseline to Week 1|GABA levels were measured in the left thalamus using single voxel magnetic resonance spectroscopy. In order to normalize the data, the GABA values were expressed as a ratio to levels of creatine, since creatine levels are not expected to vary significantly.|baseline and 1 week|||ratio (GABA to creatine)||Standard Deviation|Mean
785391|NCT00826111|Secondary|Change in Anterior Cingulate Cortex GABA From Baseline to Week 1|GABA levels were measured in the anterior cingulate cortex using single voxel magnetic resonance spectroscopy. In order to normalize the data, the GABA values were expressed as a ratio to levels of creatine, since creatine levels are not expected to vary significantly.|baseline and 1 week|||ratio (GABA to creatine)||Standard Deviation|Mean
785392|NCT00826111|Secondary|Change in Thalamic Glutamate From Baseline to Week 1|Glutamate levels were measured in the left thalamus using single voxel magnetic resonance spectroscopy. In order to normalize the data, the glutamate values were expressed as a ratio to levels of creatine, since creatine levels are not expected to vary significantly.|baseline and 1 week|||ratio (glutamate to creatine)||Standard Deviation|Mean
785393|NCT00826111|Secondary|Change in Anterior Cingulate Cortex Glutamate From Baseline to Week 1|Glutamate levels were measured in the anterior cingulate cortex using single voxel magnetic resonance spectroscopy. In order to normalize the data, the glutamate values were expressed as a ratio to levels of creatine, since creatine levels are not expected to vary significantly.|baseline and 1 week|||ratio (glutamate to creatine)||Standard Deviation|Mean
785394|NCT00826111|Primary|Change in Thalamic Glutamine From Baseline to Week 1|Glutamine levels were measured by single voxel magnetic resonance spectroscopy in the left thalamus. In order to normalize the data, the glutamine values were expressed as a ratio to levels of creatine, since creatine levels are not expected to vary significantly.|baseline and 1 week|Participants were included in the analysis if they had usable spectroscopy data from baseline and week 1 and were not considered to have any confounding issues such as an abnormal structural MRI.||ratio (glutamine to creatine)||Standard Deviation|Mean
785395|NCT00826111|Primary|Change in Anterior Cingulate Cortex Glutamine From Baseline to Week 1.|Glutamine levels were measured by single voxel magnetic resonance spectroscopy. In order to normalize the data, the glutamine values were expressed as a ratio to levels of creatine, since creatine levels are not expected to vary significantly.|baseline and 1 week|Participants who had usable MRS data from both the baseline and week 1 scans were included in the analysis. Participants whose data was considered unreliable were excluded.||ratio (glutamine to creatine)||Standard Deviation|Mean
785396|NCT00836277|Secondary|1-year (Overall) Survival Rate||1 year|||percentage of participants|||Number
785399|NCT00836277|Primary|Clinical Benefit Rate (CBR)|Using RECIST v1.0 criteria, clinical benefit rate (CBR) = # participants with (PR) + # participants with (CR) + # participants with (SD) / # participants with (PR) + # participants with (CR) + # participants with (SD) + # participants with (PD). This proportion was subsequently multiplied by 100. RECIST v1.0 criteria for Target Lesions is defined as: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Up to 14 months|||percentage of participants||95% Confidence Interval|Number
785400|NCT00836277|Primary|Response Rate (RR)|Response rate (RR) = the # participants with partial response (PR) + # participants with (CR) / # participants with (PR) + # participants with (CR ) + # participants with (SD) + # participants with (PD). This proportion was subsequently multiplied by 100. RECIST v1.0 criteria for Target Lesions was used: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started|Up to 14 months|||percentage of participants||95% Confidence Interval|Number
785401|NCT00836342|Secondary|Skin Carotenoid Levels in Subjects With History of Basal Cell Carcinoma Versus Control Group||baseline|||Raman spectrocopy intensity counts||Standard Deviation|Mean
785402|NCT00836342|Secondary|Skin Carotenoid Levels in Subjects With History of Squamous Cell Carcinoma Versus Subjects With History of Basal Cell Carcinoma||baseline|||Raman spectroscopy intensity counts||Standard Deviation|Mean
785403|NCT00836342|Primary|Skin Carotenoid Levels in Subjects With History of Squamous Cell Carcinoma Versus Control Subjects|Mean carotenoid levels in subjects with a history of squamous cell carcinoma were compared to mean carotenoid levels in control subjects without a history of nonmelanoma skin cancer.|baseline|Participants that passed inclusion criteria and consented for skin carotenoid measurement were analyzed.||Raman spectroscopy intensity counts||Standard Deviation|Mean
785404|NCT00836355|Secondary|Modified Rankin Scale Score||Baseline, and approximately one week and 3 months later|This trial was terminated early because of logistical challenges in data collection. No outcome measures data was able to be collected.|||||
785405|NCT00836355|Secondary|NIH Stroke Scale Scores||Baseline and after approximately one week|This trial was terminated early because of logistical challenges in data collection. No outcome measures data was able to be collected.|||||
785406|NCT00836355|Primary|Indices of Salvaged Ischemic Penumbra and of Final Infarct Volume Based on Quantitative Volumetric Analyses of Pre- and Post-treatment Perfusion-weighted and Diffusion-weighted Brain MR Imaging||Within approximately 7 days of stroke onset|Although all participants completed the study, none of them had the necessary MRIs performed to gather outcome measure data. The study was closed once it was determined that logistically, it was not possible to complete the study at that point in time.|||||
785407|NCT00836407|Secondary|To Measure Tumor Marker Kinetics (CA 19-9) in Patients Receiving Treatment.||4 years||||||
785408|NCT00836407|Secondary|To Explore an Association Between Immune-related Adverse Events (IRAEs) and ORR.||4 years||||||
785409|NCT00836407|Secondary|To Estimate Overall Response Rate (ORR), Immune Related Best Overall Response Rate (irBOR), Progression Free Survival (PFS), and Duration of Response in Patients Receiving Treatment.||4 years||||||
785410|NCT00836407|Secondary|Overall Survival (OS)||4 years|||Months||95% Confidence Interval|Median
785411|NCT00836407|Primary|Determine if Ipilimumab Alone or in Combination With Pancreatic Tumor Vaccine Has an Acceptable Safety Profile (Less Than 33% Unacceptable Toxicity) in Subjects With Locally Advanced, Unresectable or Metastatic Pancreatic Adenocarcinoma|Unnacceptable toxicities are defined as drug related > grade 4 AEs or grade 3 AE including IRAEs not improving to < grade 2 under therapy within 2 weeks. In addition, > grade 2 eye pain or reduction of visual acuity that does not respond to topical therapy and does not improve to < grade 1 severity within 2 weeks of starting therapy, or requires systemic therapy is an unacceptable toxicity.|4 years|||Percent|||Number
785412|NCT00836433|Secondary|Change in Facility Fall Rates|Change in the risk-adjusted facility fall rates in the 6 months post intervention(s) compared to the 6 months before the intervention(s).|6 months|"This is a facility level analysis of the fall rates in the 4 facilities randomized to FALLS alone compared to the 4 receiving CONNECT + FALLS. Within these groups, medical records from 293 and 358 residents with falls were abstracted to calculate the fall rates, therefore the number of participants analyzed is not the same as the flow module."||change in falls per bed per year|Participants||Number
785413|NCT00836433|Primary|Fall-related Process Measures|The proportion of applicable fall quality indicators documented for residents with falls during the study period. Quality indicators are specific fall risk assessment or prevention activities including orthostatic blood pressure assessment, vision assessment, environmental modification (bedroom, bathroom), footwear change, physical or occupational therapy referral, psychoactive medication reduction.|6 months|Note that the number of participants analyzed is not the same as the number of participants in the flow module. This is because this outcome measure is based not on the consented staff participants in the intervention, but resident charts abstracted in the pre and post intervention periods (waiver of consent obtained).||proportion of indicators completed||Standard Deviation|Mean
785414|NCT00836472|Primary|AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Metformin|Bioequivalence based on AUC0-t|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
785415|NCT00836472|Primary|AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Metformin|Bioequivalence based on AUC0-inf|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
785418|NCT00836472|Primary|AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Glyburide|Bioequivalence based on AUC0-inf|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
785419|NCT00836472|Primary|Cmax (Maximum Observed Concentration) - Glyburide|Bioequivalence based on Cmax|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
785420|NCT00836498|Secondary|Part II: Percentage of Participants With a >=3-fold Rise From Baseline of Serum Anti-rotavirus IgA and SNA Responses to Rotavirus Serotypes G1, G2, G3, G4 and P1A|Part II was not conducted due to study termination; this report summarizes study results from Part I only.|Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3||||||
785421|NCT00836498|Secondary|Part II: Geometric Mean Titers (GMTs) of Serum Neutralizing Antibody (SNA) Responses to G1, G2, G3, G4, and P1A|Part II was not conducted due to study termination; this report summarizes study results from Part I only.|Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3||||||
785422|NCT00836498|Secondary|Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype P1A[8]||Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo|"All endpoints exclude protocol violators & participants with invalid data based on laboratory determinations.
Analyses of endpoints based on a Per-protocol (PP) population: participants who received at least one dose study designed material and had at least one valid assay result within study specified time window & were not protocol violators."||titers||95% Confidence Interval|Geometric Mean
785423|NCT00836498|Secondary|Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G4||Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo|"All endpoints exclude protocol violators & participants with invalid data based on laboratory determinations.
Analyses of endpoints based on a Per-protocol (PP) population: participants who received at least one dose study designed material and had at least one valid assay result within study specified time window & were not protocol violators."||titers||95% Confidence Interval|Geometric Mean
785424|NCT00836498|Secondary|Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G3||Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo|"All endpoints exclude protocol violators & participants with invalid data based on laboratory determinations.
Analyses of endpoints based on a Per-protocol (PP) population: participants who received at least one dose study designed material and had at least one valid assay result within study specified time window & were not protocol violators."||titers||95% Confidence Interval|Geometric Mean
785425|NCT00836498|Primary|Part II: Geometric Mean Titer (GMT) of Serum Anti-rotavirus Immunoglobulin A (IgA)|Part II was not conducted due to study termination; this report summarizes study results from Part I only.|Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3||||||
785426|NCT00836498|Secondary|Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G2||Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo|"All endpoints exclude protocol violators & participants with invalid data based on laboratory determinations.
Analyses of endpoints based on a Per-protocol (PP) population: participants who received at least one dose study designed material and had at least one valid assay result within study specified time window & were not protocol violators."||titers||95% Confidence Interval|Geometric Mean
785427|NCT00836498|Secondary|Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G1||Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo|"All endpoints exclude protocol violators & participants with invalid data based on laboratory determinations.
Analyses of endpoints based on a Per-protocol (PP) population: participants who received at least one dose study designed material and had at least one valid assay result within study specified time window & were not protocol violators."||titers||95% Confidence Interval|Geometric Mean
785428|NCT00836498|Primary|Part II: Number of Participants With Serious Adverse Experiences|Part II was not conducted due to study termination; this report summarizes study results from Part I only.|Up to 180 days following the third dose of RotaTeq™ and/or placebo||||||
785429|NCT00836498|Primary|Part II: Number of Participants With Nonserious Adverse Experiences|Part II was not conducted due to study termination; this report summarizes study results from Part I only.|Up to 42 days following any dose of RotaTeq™ and/or placebo||||||
785430|NCT00836498|Primary|Part I: Geometric Mean Titers (GMT) of Serum Anti-rotavirus Immunoglobulin A (IgA)|GMTs of serum anti-rotavirus IgA responses after 1, 2, or 3 doses of RotaTeq™ or placebo.|Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo|"All endpoints exclude protocol violators & participants with invalid data based on laboratory determinations.
Analyses of endpoints based on a Per-protocol (PP) population: participants who received at least one dose study designed material and had at least one valid assay result within study specified time window & were not protocol violators."||titers||95% Confidence Interval|Geometric Mean
785431|NCT00836498|Primary|Part I: Number of Participants With Serious Adverse Experiences (SAEs)|"All randomized participants were contacted via telephone or in-center visit on Days 7, 14, 28, and 42 after each dose. Participants received a Vaccination Report Card (VRC) at each vaccination visit as well as instructions for recording AEs. Participants were also instructed to record potential acute gastroenteritis episodes (AGEs) that occurred within 42 days after any dose on the report card.
SAEs were followed by passive surveillance (in which either participants self reported or information was collected at participants' last visit) for 180 days following the final dose."|Up to 180 days following the third dose of RotaTeq™ or placebo|"All randomized participants who received at least one dose of RotaTeq™ or placebo are included in the summaries.
Number of participants with one or more adverse experience."||participants|||Number
785432|NCT00836498|Primary|Part I: Number of Participants With Nonserious and Serious Adverse Experiences (AEs)|All randomized participants were contacted via telephone or in-center visit on Days 7, 14, 28, and 42 after each dose. Participants received a Vaccination Report Card (VRC) at each vaccination visit as well as instructions for recording AEs. Participants were also instructed to record potential acute gastroenteritis episodes (AGEs) that occurred within 42 days after any dose on the report card.|Up to 42 days following any dose of RotaTeq™ or placebo|"All randomized participants who received at least one dose of RotaTeq™ or placebo are included in the summaries.
Number of participants with one or more adverse experience."||participants|||Number
785434|NCT00836641|Primary|Immunogenicity of Pneumococcal Vaccination|we performed pneumococcal serotype specific ELISA according to WHO's criteria for protective threshold values (>0.35 µg/ml).|12 months|we performed a power calculation in advance. To demonstrate a difference wit p<0.05, we would require 30 subjects per arm each. Thus and to allow potential drop-outs, we included 35 subjects per arm.||[µg/ml]||95% Confidence Interval|Geometric Mean
785435|NCT00836693|Secondary|Global Assessment Question (GAQ) Question 2 at 12 Week Endpoint|GAQ Question 2: Choose the one number which best describes how you perceive your sexual life is now, compared to how it was before you began taking medication in this study. Responses range from 1=very much better to 7=very much worse.|Week 12|The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.||participants|||Number
785436|NCT00836693|Secondary|Global Assessment Question (GAQ) Question 1 at 12 Week Endpoint|GAQ Question 1: Choose the one number which best describes how you perceive your ability to achieve and maintain your erections now, compared to how it was before you began taking medication in this study. Responses range from 1=very much better to 7=very much worse.|Week 12|The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.||participants|||Number
785437|NCT00836693|Secondary|"Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 5 Percentage of Yes Responses"|"Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 5. Were you satisfied overall with this sexual experience? Data are presented as the mean percentage of yes responses per participant."|Baseline, 12 weeks|The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.||percentage of yes responses||Standard Deviation|Mean
785438|NCT00836693|Secondary|"Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 4 Percentage of Yes Responses"|"Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 4. Were you satisfied with the hardness of your erection? Data are presented as the mean percentage of yes responses per participant."|Baseline, 12 weeks|The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.||percentage of yes responses||Standard Deviation|Mean
785439|NCT00836693|Secondary|"Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 1 Percentage of Yes Responses"|"Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 1. Were you able to achieve at least some erection (some enlargement of the penis)?  Data are presented as the mean percentage of yes responses per participant."|Baseline, 12 weeks|The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.||percentage of yes responses||Standard Deviation|Mean
785440|NCT00836693|Secondary|Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Overall Satisfaction (OS)|Self-reported overall satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 2 questions of the IIEF-OS domain range from 0 to 10.|Baseline, 12 weeks|The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.||units on a scale||Standard Deviation|Mean
785441|NCT00836693|Secondary|Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Intercourse Satisfaction (IS)|Self-reported intercourse satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction) to 5 (high satisfaction), thus the 3 questions of the IIEF-IS domain range from 0 to 15.|Baseline, Week 12|The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.||units on a scale||Standard Deviation|Mean
785442|NCT00836693|Secondary|Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Sexual Desire (SD)|Self-reported overall satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 2 questions of the IIEF-SD domain range from 0 to 10.|Baseline, 12 weeks|The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.||units on a scale||Standard Deviation|Mean
785443|NCT00836693|Secondary|Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Orgasmic Functions (OF)|Self-reported overall satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction) to 5 (high satisfaction), thus the 2 questions of the IIEF-OF domain range from 0 to 10.|Baseline, Week 12|The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.||units on a scale||Standard Deviation|Mean
785444|NCT00836693|Secondary|Change From Baseline to 12 Week Endpoint in Total and Subdomain Scores of the Self-Esteem and Relationship (SEAR) Questionnaire|SEAR measures improvement in self-esteem and relationship satisfaction. Questionnaire consists of two domains, Sexual Relationship (items 1-8) and Confidence (items 9-14). All questions except negatively worded questions 8 and 11 are scored from 1=almost never/never to 5=almost always/always. Questions 8 and 11 were reverse scored, thus a higher score signifies a more favorable response for all 14 items. Overall score is transformed into a 0 (least favorable) to 100 (most favorable) scale.|Baseline, Week 12|The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.||units on a scale||Standard Deviation|Mean
785445|NCT00836693|Secondary|The Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire at 12 Week Endpoint|The subject questionnaire consists of 11 questions. Each question is rated on a scale of 0 (extremely low treatment satisfaction) to 4 (extremely high treatment satisfaction). The EDITS summary score will be obtained by adding each individual result for all questions, dividing by the number of questions answered (mean satisfaction score), and multiplying by 25, thus obtaining a score that ranges from 0 (extremely low treatment satisfaction) to 100 (extremely high satisfaction).|Week 12|The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.||units on a scale||Standard Deviation|Mean
785446|NCT00836693|Secondary|Change From Baseline to 12 Week Endpoint in the Frequency of Spontaneous Morning Erections Captured by Patient Diary|The morning erection diary allows the participant to record whether he experienced an erection on waking. The participant is to complete the morning erection diary every morning during the run-in, treatment and follow-up periods. The percentage of mornings the participant reported an erection is analysed.|Baseline, 12 weeks|The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.||percent||Standard Deviation|Mean
785609|NCT00838682|Secondary|Rebleeding After 3 Days|Rebleeding after 3 days was assessed by checking the patients from day 3 to discharge and bleeding event or regular follow-up after discharge to week 6.|6wk|intention to treat (ITT)||participants|||Number
785447|NCT00836693|Secondary|Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Percentage Volumetric Change|NPT was measured using electrobioimpedance volumetric assessment (NEVA). The NEVA device measures a man's erections during the night. The percent of volume change of the penis during erections is measured and recorded for each erection. Data presented are mean percentage of volumetric change from baseline to Week 12.|Baseline, Week 12|The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.||percent of volumetric change||Standard Deviation|Mean
785448|NCT00836693|Secondary|Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Duration of Erectile Events Per Night|NPT was measured using electrobioimpedance volumetric assessment (NEVA). The NEVA device measures a man's erections during the night. The duration of erections are measured and recorded. Data presented are the duration of erectile events at baseline and the change from baseline to Week 12.|Baseline, Week 12|The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.||minutes||Standard Deviation|Mean
785449|NCT00836693|Secondary|Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Number of Erectile Events Per Night|NPT was measured using electrobioimpedance volumetric assessment (NEVA). The NEVA device measures a man's erections during the night. The man wears the device for three nights prior to visit 2 (baseline), visit 5 (end of randomised treatment) and visit 6 (end of follow-up). Data are entered for the 2 nights prior to the visit. During the night the man may have multiple erections. The number of erections is recorded.|Baseline, Week 12|The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.||Number of events per night||Standard Deviation|Mean
785450|NCT00836693|Primary|Sexual Encounter Profile (SEP) Diary, Question 3 Change From Baseline to Week 12 in Percentage of Yes Responses|"Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 3. Did your erection last long enough for you to have successful intercourse? Data are presented as the mean percentage of yes responses per participant."|Baseline, 12 weeks|The efficacy analysis of the three primary efficacy variables (IIEF-EF, SEP Question 2, and SEP Question 3) was performed on all randomized subjects who had at least one baseline and one post-baseline observation on all three variables.||percentage of yes responses||Standard Deviation|Mean
785451|NCT00836693|Primary|Change From Baseline in Question 2 of the Patient Sexual Encounter Profile (SEP) Diary at Week 12 in Percentage of Yes Responses|"Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 2. Were you able to insert your penis into your partner's vagina? Data are presented as the mean percentage of yes responses per participant."|Baseline, Week 12|The efficacy analysis of the three primary efficacy variables (IIEF-EF, SEP Question 2, and SEP Question 3) was performed on all randomized subjects who had at least one baseline and one post-baseline observation on all three variables.||percentage of yes responses||Standard Deviation|Mean
785452|NCT00836693|Primary|Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) at Week 12|Self-reported erectile function over the past 4 weeks. Scores range from 0 (low or no erectile function) to 5 (high erectile function) on 6 questions (1-5, 15 of the IIEF). Total Erectile Function Domain scores range from 0 to 30.|Baseline, Week 12|The efficacy analysis of the three primary efficacy variables (IIEF-EF, SEP Question 2, and SEP Question 3) was performed on all randomized subjects who had at least one baseline and one post-baseline observation on all three variables.||units on a scale||Standard Deviation|Mean
785453|NCT00836706|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration|Bioequivalence based on AUC0-t|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
785454|NCT00836706|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
785455|NCT00836706|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
785456|NCT00836719|Secondary|Change in Brain NAA Level as Measured by MR Spectroscopy|percent change from baseline to exit in NAA levels adjusted for creatine levels|6 months|||percentage change from baseline||95% Confidence Interval|Mean
785457|NCT00836719|Primary|Number of Participants Experiencing Serious Adverse Events||six months|||participants|||Number
785458|NCT00836745|Secondary|Number of Participants Who Required Management of Other Adverse Events|An adverse event is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Number of participants who required dose modifications and other measures for the management of other adverse events were to be presented.|Baseline up to 1 year from start of first dose|Safety analysis set included all enrolled participants who started treatment with sunitinib.||participants|||Number
785459|NCT00836745|Secondary|Number of Participants Who Required Management of Skin and Subcutaneous Tissue Related Adverse Events|An adverse event is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Number of participants who required dose modifications and other measures for the management of skin and subcutaneous tissue related adverse events were presented.|Baseline up to 1 year from start of first dose|Safety analysis set included all enrolled participants who started treatment with sunitinib.||participants|||Number
785460|NCT00836745|Secondary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to response evaluation criteria in solid tumors (RECIST). Confirmed responses were those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR defined as the disappearance of all lesions (target and/or non- target). PR those with at least 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Baseline until disease progression or discontinuation from study treatment (up to 1 year from start of first dose)|Per protocol (PP) analysis set included all enrolled participants who had the disease under study, measurable disease and an adequate baseline disease assessment, and who started sunitinib treatment.||percentage of participants||95% Confidence Interval|Number
785610|NCT00838682|Primary|Rebleeding Within 3 Days||day 3|intention to treat (ITT)||participants|||Number
785461|NCT00836745|Primary|Progression Free Survival (PFS)|PFS defined as the time (in weeks) from the date of first dose of sunitinib to the date of first documentation of objective tumor progression or death due to any cause, whichever occurs first. Date of first documentation of progression was based on radiological assessment of tumor measurements. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7.|Baseline until disease progression or death due to any cause or discontinuation from study treatment (up to 1 year from start of first dose)|Data was not analyzed since PFS for all participants was censored either due to inadequate baseline assessments, absence of on-study disease assessment, or being on follow-up for progression.|||||
785462|NCT00836875|Secondary|Time to Death||Baseline up to 1 month post treatment|Safety population; only participants who died were included in the analysis.||days||Full Range|Median
785463|NCT00836875|Secondary|Attributable Mortality - Number of Participant Deaths|Number of participant deaths attributable to study drug reported at Week 6 and at EOT (up to Week 12).|Weeks 6 and EOT (up to Week 12)|Safety population||participants|||Number
785464|NCT00836875|Secondary|All-Cause Mortality - Number of Participant Deaths|Number of participant deaths reported at Week 6 and at EOT (up to Week 12).|Week 6 and EOT (up to Week 12)|Safety population||participants|||Number
785465|NCT00836875|Secondary|Percentage of Participants With a Global Response of Success|Percentage of participants with global response of success at Weeks 6 and at EOT (up to Week 12). Global response of success was defined as a participant who achieved a complete or partial global response per the investigator. Complete response was defined as resolution of all clinical signs and symptoms PLUS resolution of 90 percent (%) or more of the lesions visible on radiological studies and attributed to invasive aspergillosis (IA) at Baseline. Partial response was defined as clinical improvement PLUS 50% to <90% resolution of the radiological lesions attributed to IA at Baseline.|Weeks 6 and End of Treatment (EOT; up to Week 12)|Modified intent to treat (MITT) population: all participants receiving at least 1 dose of study drug and diagnosed with proven or probable aspergillosis (defined by modified European Organization for Research and Treatment of Cancer Mycoses Study Group [EORTC/MSC] criteria) or microbiologically confirmed scedosporium or fusarium infection.||percentage of participants||95% Confidence Interval|Number
785466|NCT00836875|Primary|Number of Participants With Adverse Events (AEs)||Baseline, daily while hospitalized, Days 7, 14, 28, 42, 84, and 114, at end of treatment, and up to 1 month post treatment|Safety population||participants|||Number
785467|NCT00836901|Primary|AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Clavulanic Acid|Bioequivalence based on AUC0-t|Blood samples collected over 10 hour period|Data from all subjects who completed the study were included in the statistical analysis||ng*h/mL||Standard Deviation|Mean
785468|NCT00836901|Primary|AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Clavunlanic Acid|Bioequivalence based on AUC0-inf|Blood samples collected over 10 hour period|Data from all subjects who completed the study were included in the statistical analysis||ng*h/mL||Standard Deviation|Mean
785469|NCT00836901|Primary|Cmax (Maximum Observed Concentration) - Clavulanic Acid|Bioequivalence based on Cmax|Blood samples were collected over 10 hour period|Data from all subjects who completed the study were included in the statistical analysis||ng/mL||Standard Deviation|Mean
785470|NCT00836901|Primary|AUC0-t - [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)] - Amoxicillin|Bioequivalence based on AUC0-t|Blood samples collected over 10 hour period|Data from all subjects who completed the study were included in the statistical analysis||ng*h/mL||Standard Deviation|Mean
785471|NCT00836901|Primary|AUC0-inf - [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Amoxicillin|Bioequivalence based on AUC0-inf|Blood samples collected over 10 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
785472|NCT00836901|Primary|Cmax (Maximum Observed Concentration) - Amoxicillin|Bioequivalence based on Cmax|Blood samples collected over 10 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
785473|NCT00836953|Other Pre-specified|Percentage of Participants With at Least a 4-fold Rise in Reciprocal Hemagglutination Inhibition Titers (Seroconversion)|Seroconversion defined as the percentage of participants with ≥ 4-fold increases in reciprocal hemagglutination inhibition titer from pre- to post-vaccination.|Day 0 and Day 14 Post-dose 2|Immunogenicity analysis was on all enrolled and vaccinated subjects with adequate sera for testing, per-protocol population.||Percentage of Participants|||Number
785474|NCT00836953|Other Pre-specified|Percentage of Participants With Pre- and Post-Vaccination Reciprocal Hemagglutination Inhibition Titers ≥ 40 (Seroprotection)|Seroprotection defined as percentage of participants with reciprocal hemagglutination inhibition titers ≥40 pre- and post-vaccination.|Day 0 and Day 14 after Dose 2|Immunogenicity analysis was on all enrolled and vaccinated subjects with adequate sera for testing, per-protocol population.||Percentage of Participants|||Number
785475|NCT00836953|Primary|Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination|Solicited local reactions: Erythema (redness), induration, bruising and pain at the injection site. Solicited systemic reactions: Fever (temperature), irritability, crying, lethargy, appetite decreased, diarrhea, vomiting and rash.|Day 0 to 3 post-vaccination|Safety analysis was on all enrolled and vaccinated subjects with available reaction data, intent-to-treat population||Participants|||Number
785476|NCT00837031|Secondary|Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death|Length of time, in months, that patients were alive from their first date of protocol treatment until death|18 months|||months||95% Confidence Interval|Median
785477|NCT00837031|Secondary|Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease|The length of time, in months, that patients were alive from their first date of protocol treatment until worsening of their disease|18 months|||months||95% Confidence Interval|Median
785478|NCT00837031|Primary|Six-Month Overall Survival (OS) Probability, the Percentage of Patients Estimated to be Alive Six Months After Beginning Protocol Treatment|The percentage of patients who were alive 6 months after beginning treatment|6 months|||percentage of participants||95% Confidence Interval|Number
785480|NCT00837161|Secondary|Discomfort Level|Patient's self-assessed discomfort level on a 4-point scale, with: 0 = no pain; 1 = mild; 2 = moderate; 3 = severe.|Treatment Day: Baseline, Recovery, Discharge; Follow-up: 24 hours, 48 hours, 72 hours, 1 week, 2 weeks|"Subjects were included into analysis at a given time point if they had not received hysterectomy yet prior to that time point.
Analysed subject numbers were:
from baseline up to including 72 hours: 11 subjects (per protocol population); at 1 week: 6 subjects; at 2 weeks: 4 subjects;"||units on a scale||Full Range|Mean
785481|NCT00837161|Secondary|Numerical Range Scale (NRS) of Pain Level|Pain Scores obtained by patient self-assessment on a 0-10 scale, with 0 corresponding to no pain and 10 corresponding to maximum pain.|Treatment Day: Baseline, Recovery, Discharge; Follow-up: 24 hours, 48 hours, 72 hours, 1 week, 2 weeks|"Subjects were included into analysis at a given time point if they had not received hysterectomy yet prior to that time point.
Analysed subject numbers were:
from baseline up to including 72 hours: 11 subjects (per protocol population); at 1 week: 6 subjects; at 2 weeks: 4 subjects;"||units on a scale||Full Range|Mean
785482|NCT00837161|Secondary|Length of Time to Return to Normal Activities|Length of time to return to normal activity measured in number of days from HIFU treatment. Assessed by patient interviews during follow-up.|end of follow-up (date of hysterectomy, at latest day 30 after treatment)]|per protocol||days||Full Range|Mean
785483|NCT00837161|Secondary|HIFU Treatment Equals Location Per Hysterectomy|Count the number of participants in which both of the following conditions are satisfied: the fibroid treated area as shown on MRI images during treatment is the same as displayed on fibroids from histology slices after hysterectomy, and no unintended lesions are visible in the uterus.|Day 0, Hysterectomy|All participants who underwent hysterectomy following MR-HIFU treatment were included in this endpoint measure. Patients who refused hysterectomy were not included.||participants|||Number
785484|NCT00837161|Primary|Treatment-related Adverse Events (AE) Per Subject Resulting From HIFU Treatment of the Uterine Fibroids|The number of treatment-related Adverse Events (AE) reported during the study, divided by the total number of treated subjects. This corresponds to the mean number of treatment-related Adverse Events per subject. Relatedness of an AE to the treatment was judged case-by-case by the investigator.|end of follow-up (date of hysterectomy, at latest day 30 after treatment)|Safety was assessed per protocol; all 11 participants were evaluated for adverse events after HIFU treatment.||treatment-related AE/patient||Full Range|Mean
785485|NCT00837200|Primary|Study Specific Measure (Number of Participants Taken Off Study)||16 weeks|||participants|||Number
785486|NCT00837200|Primary|Study Specific Measure (Response)||16 Weeks|||participants|||Number
785487|NCT00837200|Primary|Tumor Response|"Leukemias mainly w/peripheral blood counts/diff every 2 wks/CLL, CT scan before initiation of study, 2nd CT after EOT, no CT at FU
Lymphomas restaged w/CT scans of chest/abdomen/pelvis or PET/CT scans after 2 cycles
MM monitored w/tumor markers monthly Quantitative immunoglobulins/SPEP w/quantitative M component in MM pts producing full antibody, UPEP w/ quantitative Bence-Jones in MM pts producing only light chains/Serum free light chains obtained all pts/Skeletal surveys at baseline Tumor responses:CR complete resolution of all detectable clinical/radiographic evidence of disease, disappearance of all disease related symptoms, and normalization of biochemical abnormalities for at least 6 wks following treatment and no BM infiltration;PR reduction of all measurable lesions by 50% or more/no new lesions;SD not fulfilling PR criteria/no evidence disease progression;PD increase original tumor mass by more than 25% lesion/new lesion
Stable disease > 2mo was a response"|16 weeks|||participants|||Number
785488|NCT00837213|Secondary|Percentage of Particpants With IGA Score at Week 16|"Investigator Global Assessment (IGA) at Week 16 based on the Investigator Global Assessment
IGA:
0 - Clear
0.5 - Clear/almost clear
Almost Clear
1.5- Almost Clear/Mild
Mild
2.5- Mild/Moderate
Moderate
3.5- Moderate/Severe"|Baseline, Week 16|Subjects who completed week 16||Percent of participants|||Number
785489|NCT00837213|Primary|Change in Investigator Global Assessment (IGA)|"Change in Investigator Global Assessment (IGA) Average values chest and back.
IGA scale:
0 - Clear
0.5 - Clear/almost clear
Almost Clear
1.5- Almost Clear/Mild
Mild
2.5- Mild/Moderate
Moderate
3.5- Moderate/Severe"|Baseline, Weeks 4, 8,12, and 16|ITT||Units on a scale||Standard Deviation|Mean
785490|NCT00837213|Secondary|Percent Change in Total Lesions (Chest and Back) From Baseline to Week 12|Percent change in total lesions (chest and back) from baseline to Week 12|Week 12|ITT||Percent change||Standard Deviation|Mean
785491|NCT00837213|Secondary|Percent Change in Non-inflammatory Lesions (Chest and Back) From Baseline to Week 12|Percent change in non-inflammatory lesions (chest and back) from baseline to Week 12|Baseline, Week 12|ITT||Percent change||Standard Deviation|Mean
785492|NCT00837213|Secondary|Percent (%) Change in Inflammatory Lesion Counts (Chest and Back) From Baseline to Week 12|Percent change in inflammatory lesion counts (chest and back)from Baseline to Week 12|Baseline, Week 12|ITT||Percent Change||Standard Deviation|Mean
785493|NCT00837213|Primary|Percent Change in Total Acne Lesion Counts From Baseline to Week 16|Percent change from baseline to week 16 in total acne lesions (inflammatory + non-inflammatory)|Baseline, Week 16|ITT||Percent Change||Standard Deviation|Mean
785494|NCT00837213|Primary|Percent (%) Change in Non-inflammatory Acne Lesions From Baseline to Week 16.|Percent change in Non-inflammatory acne lesions (whiteheads and blackheads)(chest and back) from baseline to week 16.|Baseline, Week 16|ITT||Percent Change||Standard Deviation|Mean
785495|NCT00837213|Primary|Percent Change in Inflammatory Acne Lesions From Baseline to Week 16|Percent change from baseline to week 16 in inflammatory acne lesions (pustules/papules)(chest and back)|Baseline, Week 16|ITT||Percent change||Standard Deviation|Mean
785496|NCT00837252|Secondary|Change in Urinary Cortisol Level at Month 6 Compared to Baseline|The amount of cortisol found in urine was assessed from each participant at baseline and at Month 6. The mean change from baseline to Month 6 is reported here in micrograms.|6 Months|||µg||Standard Deviation|Mean
785497|NCT00837252|Secondary|Change in Urinary Cortisol Level at Month 3 Compared to Baseline|The amount of cortisol found in urine was assessed from each participant at baseline and at Month 3. The mean change from baseline to Month 3 is reported here in micrograms.|3 Months|||µg||Standard Deviation|Mean
785498|NCT00837252|Secondary|Change in Serum Testosterone Level at Month 6 Compared to Baseline|The concentration of testosterone in blood serum was assessed from each participant at baseline and at Month 6. The mean change from baseline to Month 6 is reported here in nanograms of testosterone per decaliter of serum.|6 Months|||ng/dL||Standard Deviation|Mean
785499|NCT00837252|Secondary|Change in Serum Testosterone Level at Month 3 Compared to Baseline|The concentration of testosterone in blood serum was assessed from each participant at baseline and at Month 3. The mean change from baseline to Month 3 is reported here in nanograms of testosterone per decaliter of serum.|3 Months|||ng/dL||Standard Deviation|Mean
785500|NCT00837252|Secondary|Change in Serum Dihydrotestosterone (DHT) Concentration at Month 6 Compared to Baseline|The concentration of dihydrotestosterone (DHT) in blood serum was assessed from each participant at baseline and at Month 6. The mean change from baseline to Month 6 is reported here in picograms of DHT per milliliter of serum.|6 Months|Only the 3 patients who were rechallenged with finasteride after Month 3 were included in this analysis.||pg/mL||Standard Deviation|Mean
785501|NCT00837252|Secondary|Change in Serum Dihydrotestosterone (DHT) Concentration at Month 3 Compared to Baseline|The concentration of dihydrotestosterone (DHT) in blood serum was assessed from each participant at baseline and at Month 3. The mean change from baseline to Month 3 is reported here in picograms of DHT per milliliter of serum.|3 Months|||pg/mL||Standard Deviation|Mean
785502|NCT00837252|Secondary|Change in Subretinal Fluid Volume at Month 6 Compared to Baseline|"Subretinal fluid volume was calculated after manually outlining the inner and outer borders of the subretinal fluid packet in the optical coherence tomography (OCT) images using the Edit Segmentation function of the Cirrus HD-OCT software. In cases where a pigment epithelial detachment was present, the volume of the pigment epithelial detachment was included in the calculation of subretinal fluid volume."|6 Months|||µL||Standard Deviation|Mean
785503|NCT00837252|Secondary|Change in Subretinal Fluid Volume at Month 3 Compared to Baseline|"Subretinal fluid volume was calculated after manually outlining the inner and outer borders of the subretinal fluid packet in the optical coherence tomography (OCT) images using the Edit Segmentation function of the Cirrus HD-OCT software. In cases where a pigment epithelial detachment was present, the volume of the pigment epithelial detachment was included in the calculation of subretinal fluid volume."|3 Months|||µL||Standard Deviation|Mean
785504|NCT00837252|Secondary|Change in Center-Subfield Macular Thickness at Month 6 Compared to Baseline|Central-subfield macular thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|6 months|||µm||Standard Deviation|Mean
785505|NCT00837252|Secondary|Change in Center-Subfield Macular Thickness at Month 3 Compared to Baseline|Central-subfield macular thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|3 months|||µm||Standard Deviation|Mean
785506|NCT00837252|Secondary|Change in Visual Acuity at Month 6 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. This acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters the Snellen measurement is 20/20.|6 months|||ETDRS letters||Standard Deviation|Mean
785507|NCT00837252|Primary|Change in Visual Acuity at Month 3 Compared to Baseline.|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. This acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters the Snellen measurement is 20/20.|3 months|||ETDRS letters||Standard Deviation|Mean
785508|NCT00837330|Primary|Commonly Reported and Notable Adverse Events|Incidence and severity of ocular adverse events, as identified by indirect and direct examination. Examples include 30 letter loss, major subretinal hemorrhage, involving 75% or more of clinical macula (arcade to arcade), disease-related vitreous hemorrhage, injection-related endopthalmitis, retinal detachment, vitreous hemorrhage, study drug/procedure related uveitis, incidence and severity of other adverse events, as identified by physical examination, subject reporting, and changes in vital signs.|2 years|||participants|||Number
785516|NCT00837447|Primary|Change in Knee Society Knee Score|"change in knee score will be compared with baseline and follow up of 3 years. The knee society knee score range from 0 to 100 points, 100 being the best possible outcome.
Baseline-NexGen (CR) knee socre:29 points Baseline-NexGen (CR-Flex) knee socre:29 points Follow up of 3 years-NexGen (CR) knee socre: 93.7 points Follow up of 3 years-NexGen (CR-Flex) knee socre: 93.9 points"|baseline and 3 years|||scores on a scale||Standard Deviation|Mean
785517|NCT00837486|Other Pre-specified|Therapy-related Adverse Events|Adverse events related to the device, implant procedure, and/or stimulation are reported. Events with a prevalence of greater than 5% of subjects are reported. This measure describes the experience of all study participants (both Active and Control Groups combined), and includes the operative, blinded-treatment,and the long-term open-label follow-up phases combined. Active Group participants began therapy after randomization, while Control Group participants began therapy after 16 weeks of sham stimulation.|from enrollment to study closure (average follow-up of 36 months)|All enrolled participants are included in the analysis.||participants|||Number
785518|NCT00837486|Other Pre-specified|Long-term Open-label Responders|This measure is for long-term, open-label stimulation. Response is defined as at least a 50% improvement (decline) in MADRS score. Responder rate is the proportion of participants who experience response. All enrolled participants are included in the analysis, even if they withdrew early. Participants that withdrew early are counted as non-responders.|at the 24-month visit|29 participants started the the Long-Term Follow-up Phase and 24 completed the phase, but all 30 enrolled participants are included in the analysis. Participants that withdrew early are counted as non-responders.||participants|||Number
785519|NCT00837486|Secondary|Quality of Life Change|Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF); total score can range from 0 to 100 with higher scores indicating a better quality of life. Improvement is measured by the groups' mean change in Q-LES-Q-SF score. An improvement is represented by an increase in Q-LES-Q-SF (a positive change).|Baseline to 16 weeks|One active group subject did not receive the allocated treatment, and is not included in the primary and secondary efficacy outcome analyses.||change from baseline score||Standard Deviation|Mean
785520|NCT00837486|Secondary|Depression Change|Montgomery-Åsberg Depression Rating Scale (MADRS); total score can range from 0 (no symptoms) to 60 (severe depression). Improvement is measured by the groups' mean percent change in MADRS score. An improvement is represented by a decline in MADRS (a negative percent change).|Baseline to 16 weeks|One active group subject did not receive the allocated treatment, and is not included in the primary and secondary efficacy outcome analyses.||percentage change from baseline||Standard Deviation|Mean
785521|NCT00837486|Primary|Responders|Montgomery-Åsberg Depression Rating Scale (MADRS); total score can range from 0 (no symptoms) to 60 (severe depression). Response is defined as at least a 50% improvement (decline) in MADRS score. Responder rate is the proportion of participants who experience response.|Baseline to 16 weeks|29 of the 30 subjects are included in this analysis. One active group subject did not receive the allocated treatment, and is not included in the primary and secondary efficacy outcome analyses.||participants|||Number
785523|NCT00837577|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12|Change from baseline measurement, where the baseline measurement was obtained at randomization (Week 0) before receiving study medication.|Baseline and Week 12|Full Analysis Set (FAS) defined as all randomized participants except those participants who did not provide written consent, who were found to be ineligible for the study, or have not taken any study drug during the study period.||mg/dL||95% Confidence Interval|Least Squares Mean
785524|NCT00837577|Secondary|Change From Baseline in 2-hour Postprandial Glucose at Week 12|Change from baseline measurement, where the baseline measurement was obtained at randomization (Week 0) before receiving study medication.|Baseline and Week 12|Full Analysis Set (FAS) defined as all randomized participants except those participants who did not provide written consent, who were found to be ineligible for the study, or have not taken any study drug during the study period.||mg/dL||95% Confidence Interval|Least Squares Mean
785525|NCT00837577|Primary|Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12|Change from baseline measurement, where the baseline measurement was obtained at randomization (Week 0) before receiving study medication. This study used Japan Diabetes Society (JDS)-certified HbA1c values, the standard at the time when the study was conducted (HbA1c [National Glycohemoglobin Standardization Program; NGSP] = HbA1c (JDS-HbA1c [%]) + 0.4%).|Baseline and Week 12|Full Analysis Set (FAS) defined as all randomized participants except those participants who did not provide written consent, who were found to be ineligible for the study, or have not taken any study drug during the study period.||Percentage of glycosylated hemoglobin||95% Confidence Interval|Least Squares Mean
785526|NCT00837616|Secondary|Serum Estrone Sulfate Concentrations After Using Oral Versus Transdermal 17B Estradiol Replacement for 12 Months||12 months|||pg/mL||Standard Error|Mean
785527|NCT00837616|Secondary|Serum Estrone Concentrations After Using Oral Versus Transdermal 17B Estradiol Replacement for 12 Months||12 months|||pg/mL||Standard Error|Mean
785528|NCT00837616|Primary|Characterize PK/PD and Relative Biological Potency of Different Oral vs TD Estrogen Preparations||6 weeks||||||
785529|NCT00837616|Primary|Change in Fat Free Mass From Baseline at 12 Months||12 months|||kg||Standard Error|Mean
785530|NCT00837616|Primary|Change in Percent Fat Mass From Baseline in 12 Months||12 months|||percent fat mass||Standard Error|Mean
785531|NCT00837616|Primary|Change in Body Mass Index From Baseline at 12 Months||12 months|||kg/m2||Standard Error|Mean
785532|NCT00837616|Secondary|Serum 17B Estradiol Concentrations After Using Oral Versus Transdermal 17B Estradiol Replacement for 12 Months||12 months|||pg/ml||Standard Error|Mean
785533|NCT00837616|Secondary|Rates of Lipid Oxidation After Using Oral Versus Transdermal 17B Estradiol Replacement for 12 Months||12 months|||Kcal/Fat Free Mass/day||Standard Error|Mean
785534|NCT00837616|Secondary|Lipids Concentrations After Using Oral Versus Transdermal 17B Estradiol Replacement for 12 Months||12 months|||mg/dl||Standard Error|Mean
785535|NCT00837616|Secondary|Changes in Insulin Growth Factor-I From Baseline at 12 Months||12 months|||ng/ml||Standard Error|Mean
785536|NCT00837616|Primary|Change in Weight From Baseline at 12 Months||12 months|||kilograms||Standard Error|Mean
785537|NCT00837759|Secondary|Change in ZnT8 Autoantibody Titer||6 months following the protocol subject's randomization/treatment initiation|||Titers||Standard Error|Mean
785538|NCT00837759|Secondary|Change in Anti-IA2 Titer||6 months following the protocol subject's randomization/treatment initiation|||Titers||Standard Error|Mean
785539|NCT00837759|Secondary|Change in Anti-GAD Autoantibody Titers||6 months following the protocol subject's randomization/treatment initiation|||Titers||Standard Error|Mean
785540|NCT00837759|Secondary|Change in Insulin Dose||6 months following the protocol subject's randomization/treatment initiation|||U/kg/day||Standard Deviation|Mean
785541|NCT00837759|Secondary|Glycemia Control (Change in HbA1c Level)||6 months following the protocol subject's randomization/treatment initiation|Only 3 subjects completed study||Percentage||Standard Deviation|Mean
785542|NCT00837759|Primary|Change in C-peptide||6 months following the protocol subject's randomization/treatment initiation|Only 3 subjects completed study||ng/mL||Standard Deviation|Mean
785543|NCT00837824|Secondary|Plasma Globotriaosylceramide (GL-3)|This outcome measure evaluated the mean plasma GL-3 values for all patients to see if it decreased while on Fabrazyme. Normal plasma GL-3 level is defined as ≤ 7.03 µg/mL.|Evaluated at Baseline, Month 3, and Final Visit|"Fabrazyme 1mg/kg every 2 weeks: ITT population – 11 patients at baseline, 7 patients at Month 3, and 9 patients at Final Visit had Plasma GL-3 values.
Fabrazyme 3mg/kg every 2 weeks: ITT population - 9 patients at baseline, 2 patients at Month 3, and 7 patients at Final Visit had Plasma GL-3 values"||µg/mL||Standard Deviation|Mean
785544|NCT00837824|Primary|Time to Clinically Significant Progression of Cardiac Disease, Cerebrovascular Disease, and/or Death Among Fabry Patients With Severe Kidney Disease|The trial was terminated early due to inadequate study design. During the study period of 7 months, only 1 patient had a clinical event, a stroke, in the Fabrazyme 1 mg/kg treatment arm. The time to event was determined from first dose of Fabrazyme to the date of event.|7 months|Intent-to-Treat (ITT) Population-consisted of all 20 patients enrolled in the trial. The original sample size was 120 patients. Due to early termination, only 20 patients were enrolled in this trial. No imputation of data was performed. During the 7 months study period, only 1 patient had a clinical event in the Fabrazyme 1 mg/kg treatment arm.||Days|||Number
785545|NCT00837876|Secondary|Number of Patients With Worst Grade Toxicities|Number of patients with worst-grade toxicity at each of five grades (grade 1 to 5, with 5 most severe) following NCI Common Toxicity Criteria: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, disabling, 5 = death.|every 4 weeks and every 8 weeks in follow-up to resolution of toxicity|All patients who received treatment with the study drugs. One patient did not receive treatment.||participants|||Number
785546|NCT00837876|Secondary|Number of Patients With Progression-free Survival|Participants with progression-free survival at 4 months.|at 4 months|Patients with progression-free survival at 4 months. The remaining 17 patients were not available for evaluation at 4 months due to toxicity (5), disease progression (5), patient withdrawal (1),respiratory failure (1), study drug held more than 28 days (1), and no study drug (1.||participants|||Number
785659|NCT00828984|Secondary|Change in E-cadherin Expression as Measured in Endoscopically Normal (Non-ACF) Mucosal Biopsies||6 months - baseline|The study population includes men and women of all races and ethnicities who are scheduled to undergo colonoscopy for a history of colonic neoplasia (within the past 6 years of either colonic adenoma ≥ 5 mm or carcinoma).||ng/ml||Standard Deviation|Mean
785547|NCT00837876|Secondary|Response Rate|Per RECIST criteria v. 1.0: measurable lesions: CR disappearance of target lesions, PR > 30% decrease in the sum of the longest diameter (LD) of target lesions, PD > 20% increase in the sum of the LD of target lesions or appearance of new lesions, SD neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions|at 4 months|Participants who received treatment for 4 or more months. The remaining 10 participants received treatment for less than 4 months and were not evaluable.||participants|||Number
785548|NCT00837876|Primary|Number of Patients With Progression-free Survival|Number of patients with progression-free survival at 8 weeks|at 8 weeks|Patients who received treatment for >= 8 weeks. 14 study patients were treated for < 8 weeks due to toxicity (5), disease progression (5), did not receive study drug (1), respiratory failure (1), drug held more than 28 days (1), patient withdrawal (1). The remaining 13 participants did not have a progression-free survival at 8 weeks.||participants|||Number
785549|NCT00837967|Primary|Vital Sign (Pulse Rate)- Average Trapezoidal Area Under the Curve (AUC)|The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.|up to 740 min after start dosing for each treatment day|||beats/min||Standard Deviation|Mean
785550|NCT00837967|Primary|Vital Sign (Blood Pressure)- Average Trapezoidal Area Under the Curve (AUC)|The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.|up to 740 min after start dosing for each treatment day|||mmHg||Standard Deviation|Mean
785551|NCT00837967|Primary|Electrocardiogram (ECG)- Average Trapezoidal Area Under the Curve (AUC)|The mean AUC of QTcF (ECG interval measured from the beginning of the Q wave to the end of the T wave, corrected for heart rate using Fridericia’s formula)was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.|up to 740 min after start dosing for each treatment day|||ms||Standard Deviation|Mean
785552|NCT00837967|Primary|Blood Glucose - Average Concentration From Trapezoidal Area Under the Curve (AUC)|The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.|up to 140 min after start dosing for each treatment day|||mg/dLiters||Standard Deviation|Mean
785553|NCT00837967|Primary|Serum Potassium - Average Concentration From Trapezoidal Area Under the Curve (AUC)|The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.|up to 740 min after start dosing for each treatment day|||mEq/L||Standard Deviation|Mean
785554|NCT00837967|Primary|Adverse Events|Total number of adverse events|3 days|||adverse events|||Number
785555|NCT00838097|Secondary|Number of Participants With Non-serious Adverse Drug Reactions (ADRs)|"An ADR was defined as an undesirable medical occurrence or worsening of a pre-existing medical condition that the investigator considered associated with the use of darbepoetin alfa. A non-serious ADR was one in which none of the following applied:
Fatal
Life threatening
Required or prolonged in-patient hospitalization
A persistent or significant disability/incapacity, or
A congenital anomaly/birth defect."|2 years|Full analysis set||participants|||Number
785556|NCT00838097|Secondary|Parathyroid Hormone Level by Three Monthly Intervals||Baseline, Months 3, 6, 9, 12, 15, 18, 21, and 24|Full analysis set||pmol/L||Inter-Quartile Range|Median
785557|NCT00838097|Secondary|Weight Adjusted Darbepoetin Alfa Monthly Dose by Monthly Intervals|Baseline dose = the daily dose equivalent x 30, where the daily dose equivalent = the last available dose prior to or at Day 1 / reported intended frequency.|Baseline and Months 1 to 24|Full analysis set||μg/kg/month||95% Confidence Interval|Geometric Mean
785558|NCT00838097|Secondary|Hemoglobin Concentration by Three Monthly Intervals||Baseline, Months 3, 6, 9, 12, 15, 18, 21, and 24|Full analysis set||g/dL||95% Confidence Interval|Mean
785559|NCT00838097|Primary|Number of Participants With Serious Adverse Drug Reactions (SADR), Serious Adverse Events (SAEs) or Events of Medical Interest (EMIs)|An ADR was defined as an undesirable medical occurrence or worsening of a pre-existing medical condition that the investigator considered associated with the use of darbepoetin alfa. An AE is any untoward medical occurrence or worsening of a pre-existing condition whether or not considered to have a causal relationship with darbepoetin alfa. An SADR or SAE is any ADR or AE that is either: • Fatal • Life threatening • Requires or prolongs in-patient hospitalization • A persistent or significant disability/incapacity, or • A congenital anomaly/birth defect. An EMI is defined as one of the following pre-specified AEs: Thromboembolic Events (eg, venous thrombosis, embolism, vascular occlusion) • Seizures • Severe hypertension (Investigator discretion accompanied by recorded blood pressure) • Cardiovascular events (eg, cardiac arrhythmia, myocardial ischaemia/infarction, heart failure) • Pure red cell aplasia (PRCA) • Hypersensitivity reactions (eg, rash, urticaria, anaphylaxis).|2 years|Full Analysis Set||participants|||Number
785560|NCT00838110|Primary|Percentage of Participants With Adverse Events (AEs) in Cohort 2|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|Baseline up to Week 16 (follow-up)|Cohort 2 analysis set included all those participants in the SAS (all participants who received at least one dose of study medication, including partial doses) who were randomized into cohort 2 of the study.||percentage of participants|||Number
785561|NCT00838110|Primary|Percentage of Participants With Adverse Events (AEs) in Cohort 1|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|Baseline up to Week 30 (follow-up)|Cohort 1 analysis set included all those participants in the SAS (all participants who received at least one dose of study medication, including partial doses) who were randomized into cohort 1 of the study.||percentage of participants|||Number
785562|NCT00838110|Primary|Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 2|For hematology, liver function, renal function, electrolytes, clinical chemistry, abnormality was reported if the observed value was more than or less than X times the ULN or LLN respectively; X=specified in categories of each parameter in the measured values section. For urinalysis of glucose, ketones, protein, blood, abnormality was reported if result was >=1 in qualitative test of respective parameters, indicating levels in urine were abnormal. Urine pH and specific gravity abnormality reported if pH >8 and specific gravity <1.003 or >1.030.|Baseline up to Week 16 (follow-up)|Cohort 2 analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure for each group respectively. Here, 'n' signifies those participants who were evaluable for particular category for each group respectively.||percentage of participants|||Number
785563|NCT00838110|Primary|Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 1|For hematology, liver function, renal function, electrolytes, clinical chemistry, abnormality was reported if the observed value was more than or less than X times the upper limit of normal (ULN) or lower limit of normal (LLN) respectively; X=specified in categories of each parameter in the measured values section. For urinalysis of glucose, ketones, protein, blood, abnormality was reported if result was >=1 in qualitative test of respective parameters, indicating levels in urine were abnormal. Urine pH and specific gravity abnormality reported if pH >8 and specific gravity <1.003 or >1.030.|Baseline up to Week 30 (follow-up)|Cohort 1 analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure for each group respectively. Here, 'n' signifies those participants who were evaluable for particular category for each group respectively.||percentage of participants|||Number
785564|NCT00838110|Primary|Percentage of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings in Cohort 2|Abnormal ECG findings included maximum value of >=300 msec, maximum increase of >=25% for baseline value of >200 msec and maximum increase of >=50% for baseline value of <=200 msec for PR interval; maximum value of >=200 msec, maximum increase of >=25% for baseline value of >100 msec and maximum increase of >=50% for baseline value of <=100 msec for QRS interval; maximum value of >=500 msec for QT interval; maximum value of 450 to <480, 480 to <500 and >=500 msec, increase of >=30 to <60 and >=60 msec for QT interval corrected using Fridericia’s formula (QTcF interval).|Baseline up to Week 16 (follow-up)|Cohort 2 analysis set included all those participants in the SAS (all participants who received at least one dose of study medication, including partial doses) who were randomized into cohort 2 of the study. Here, 'n' signifies those participants who were evaluable for particular category for each group respectively.||percentage of participants|||Number
785565|NCT00838110|Primary|Percentage of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings in Cohort 1|Abnormal ECG findings included maximum value of >=300 millisecond (msec), maximum increase of >=25% for baseline value of >200 msec and maximum increase of >=50% for baseline value of <=200 msec for PR interval (int); maximum value of >=200 msec, maximum increase of >=25% for baseline value of >100 msec and maximum increase of >=50% for baseline value of <=100 msec for QRS interval; maximum value of >=500 msec for QT interval; maximum value of 450 to <480, 480 to <500 and >=500 msec, increase of >=30 to <60 and >=60 msec for QT interval corrected using Fridericia’s formula (QTcF interval).|Baseline up to Week 30 (follow-up)|Cohort 1 analysis set included all those participants in the SAS (all participants who received at least one dose of study medication, including partial doses) who were randomized into cohort 1 of the study. Here, 'n' signifies those participants who were evaluable for particular category for each group respectively.||percentage of participants|||Number
785566|NCT00838110|Primary|Percentage of Participants With Abnormal Clinically Significant Vital Signs in Cohort 2|Abnormal clinically significant vital signs included absolute systolic BP values: <90 mmHg, maximum increase or decrease of >=30 mmHg from baseline; absolute diastolic BP values: <50 mmHg, maximum increase or decrease of >=20 mmHg from baseline; absolute heart rate values: >120 bpm.|Baseline up to Week 16 (follow-up)|Cohort 2 analysis set included all those participants in the SAS (all participants who receive at least one dose of study medication, including partial doses) who were randomized into cohort 2 of the study. Here, 'n' signifies those participants who were evaluable for particular category for each group respectively.||percentage of participants|||Number
785567|NCT00838110|Primary|Percentage of Participants With Abnormal Clinically Significant Vital Signs in Cohort 1|Abnormal clinically significant vital signs included absolute systolic blood pressure (BP) values: less than (<) 90 millimeter of mercury (mmHg), maximum increase or decrease of greater than or equal to (>=) 30 mmHg from baseline; absolute diastolic BP value: <50 mmHg, maximum increase or decrease of >=20 mmHg from baseline; absolute heart rate values: >120 beats per minute (bpm).|Baseline up to Week 30 (follow-up)|Cohort 1 analysis set included all those participants in the safety analysis set (SAS) (all participants who receive at least one dose of study medication, including partial doses) who were randomized into cohort 1 of the study. Here, 'n' signifies those participants who were evaluable for particular category for each group respectively.||percentage of participants|||Number
785568|NCT00838136|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 120 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
785569|NCT00838136|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 120 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
785570|NCT00838136|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 120 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
785571|NCT00838162|Secondary|Fluctuation Index of TMC310911|Fluctuation index, ie, percentage fluctuation: variation between maximum (Cmax) and minimum (Cmin) plasma concentration at steady-state, calculated as: 100 x ([Cmax-Cmin]/Css,av). Css,av is an average steady-state plasma concentration.|Day 14|Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC310911)||Percent ng/mL||Standard Deviation|Mean
785572|NCT00838162|Secondary|Average Steady-state Plasma Concentration (Css,av) of TMC310911||Day 14|Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC310911).||ng/mL||Standard Deviation|Mean
785573|NCT00838162|Secondary|Predose Plasma Concentration (C0h) of TMC310911||Day 2, Day 3, Day 4, Day 6, Day 8, Day 10, Day 12 and Day 14|Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC310911).||ng/mL||Standard Deviation|Mean
785574|NCT00838162|Secondary|Area Under the Plasma Concentration-time Curve (AUC12) From the Time of Administration of TMC310911 up to 12 Hours After Dosing||Day 1 and Day 14|Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC310911)||ng.h/mL||Standard Deviation|Mean
785575|NCT00838162|Secondary|Time to Reach the Maximum Plasma Concentration (Tmax) of TMC310911||Day 1 and Day 14|Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC310911)||hours||Full Range|Median
785578|NCT00838162|Secondary|Number of Participants With Virologic Response at Any Timepoint During the 14-day Treatment Period|Virologic response is a viral load test result below a chosen threshold value (less than 50 copies/mL, less than 400 copies/mL, or at least 1 log drop in viral load) at any timepoint during a 14-day treatment of 4 different dose regimens of TMC310911 coadministered with 100 mg ritonavir.|14 days|Intent-to-treat (ITT) Population- all randomized participants who received at least 1 dose of study medication (TMC310911)||Participants|||Number
785579|NCT00838162|Primary|Mean Changes From Baseline in Plasma log10 Human Immunodeficiency Virus Type 1 Ribonucleic Acid (HIV-1 RNA)|The antiviral activity of TMC310911 is measured by the change in viral load from baseline in the 14 days of treatment following initiation of treatment with 4 different dosing regimens of TMC310911 coadministered with ritonavir.|Baseline (Day 1), Day 8, Day 15|Intent-to treat (ITT) population- participants who received at least 1 dose of study medication (TMC310911).||log10 copies/mL||Standard Error|Mean
785580|NCT00838201|Primary|Overall Survival Through Month 24||24 months|Full Analysis Set||Participants|||Number
785581|NCT00838279|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 120 hour period|Two subjects did not complete the study, and there was an issue with dosing of one subject (the whole tablet was not consumed for one of the periods) therefore there are 29 data sets that were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
785582|NCT00838279|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 120 hour period|Two subjects did not complete the study, and there was an issue with dosing of one subject (the whole tablet was not consumed for one of the periods) therefore there are 29 data sets that were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
785583|NCT00838279|Primary|Cmax - Maximum Observed Concentration|Bioequivalence basd on Cmax|Blood samples collected over 120 hour period|Two subjects did not complete the study, and there was an issue with dosing of one subject (the whole tablet was not consumed for one of the periods) therefore there are 29 data sets that were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
785584|NCT00838331|Primary|The Effects of Storage-related RBC Changes on Acetylcholine-stimulated (NO-mediated) Forearm Blood Flow.|The primary outcome measures are changes in forearm blood flow (FBF) in recipients of fresh or stored RBC transfusions in response to acetylcholine. Secondary measures include changes in FBF with acetylcholine with or without L-NMMA, and changes in FBF with forearm exercise. In addition, flow mediated dilation (FMD) measurements will also be used to assess changes in brachial artery diameter before and after fresh vs aged RBC transfusions.|5 years|||mL / 100 mL / min||Standard Deviation|Mean
785585|NCT00838513|Secondary|Pharmacokinetics (PK) and Pharmacodynamics (PD); Minimum and Maximum Blood Concentration||Induction Phase for 4 weeks followed by Maintenance Phase starting on Week 5 through 26 weeks or longer.|PK parameters Cmin and Cmax were estimated using a population PK model developed from the observed PK concentration data.||micrograms/mil||Standard Deviation|Mean
785586|NCT00838513|Secondary|Percentage of Patients With Platelet Count Normalization|Platelet count normalization was defined as the platelet count observed to be ≥150 x 10^9/L on at least two consecutive measurements which span a period of at least four weeks Not specified.|Through End of Study, Median Exposure 156 Weeks|The tabulations of the proportion of patients who achieved platelet count normalization through end of study were performed for the ITT population. Exact binomial 95% confidence intervals were produced for the analysis.||Percentage of Participants||95% Confidence Interval|Number
785587|NCT00838513|Secondary|Platelet Count Change From Baseline to 156 Weeks||From Baseline to 156 Weeks|Change from baseline platelet counts were analyzed for the ITT population using a repeated measurement ANOVA model. A least squares (LS) mean for the change from baseline was produced for each study day for which a measurement of platelet count was scheduled. Significance of change was assessed at the 5% level at each time point.||10^9 cells/L||95% Confidence Interval|Least Squares Mean
785588|NCT00838513|Secondary|TMA Intervention Rate|TMA Intervention Rate (# PE/PI and # Dialysis Events/Patient/Day) in the eculizumab treatment period (from baseline through end of study) for PE/PI and (from the fifteenth day following the first eculizumab dose through end of study) for new dialysis events was compared with the TMA Intervention Rate during the pre-eculizumab treatment period.|Through End of Study, Median Exposure 156 Weeks|A signed rank test assessed differences in magnitudes of change in TMA intervention rate between the pre-eculizumab treatment period and during eculizumab treatment period for ITT population.||#events/patient/day||Standard Deviation|Mean
785589|NCT00838513|Secondary|Percentage of Patients With Complete TMA Response|The proportion of patients who achieved a Complete TMA Response from baseline through end of study with eculizumab was determined. Complete TMA Response was defined as Hematologic Normalization plus improvement in renal function (defined as (≥25% reduction from baseline in serum creatinine), which was sustained for two consecutive measurements over a period of at least four weeks.|Through End of Study, Median Exposure 156 Weeks|Tabulations of the proportion of patients who achieved a complete TMA response from baseline through end of study were performed. For this endpoint, for any relevant proportions, exact binomial 95% confidence intervals were produced.||Percentage of Participants||95% Confidence Interval|Number
785590|NCT00838513|Secondary|Percentage of Patients With Hematologic Normalization|Hematologic Normalization was defined as normalization of both platelet count and lactic dehydrogenase (LDH) sustained for at least two consecutive measurements which spanned a period of at least four weeks.|Through End of Study, Median Exposure 156 Weeks|Tabulations of the proportion of patients who achieved a hematologic normalization through end of study were performed for the ITT population. Exact 95% binomial confidence intervals were produced for the analysis.||Percentage of Participants||95% Confidence Interval|Number
785591|NCT00838513|Secondary|Percentage of Patients With TMA Event-free Status|TMA Event-free status is defined as the absence for at least 12 weeks of [1] decrease in platelet count of > 25% from the Platelet Count Pre-PT Baseline Set Point; [2] PT while the patient is receiving eculizumab, and [3] new dialysis.|Through End of Study, Median Exposure 156 Weeks|The tabulations of the proportions of patients who achieved a TMA Event-Free status through 26 weeksend of study were performed for the ITT population. Exact binomial 95% confidence intervals were produced for the analysis.||Percentage of Participants||95% Confidence Interval|Number
785592|NCT00838513|Secondary|Percentage of Patients With Platelet Count Normalization|Platelet count normalization was defined as the platelet count observed to be ≥150 x 10^9/L on at least two consecutive measurements which span a period of at least four weeks|Through 26 Weeks|The tabulations of the proportion of patients who achieved platelet count normalization through 26 weeks were performed for the ITT population. Exact binomial 95% confidence intervals were produced for the analysis.||Percentage of Participants||95% Confidence Interval|Number
785593|NCT00838513|Secondary|Platelet Count Change From Baseline to 26 Weeks||From Baseline to 26 Weeks|Change from baseline platelet counts were analyzed for the ITT population using a repeated measurement ANOVA model. A least squares (LS) mean for the change from baseline was produced for each study day for which a measurement of platelet count was scheduled. Significance of change was assessed at the 5% level at each time point.||10^9 cells/L||95% Confidence Interval|Least Squares Mean
785594|NCT00838513|Secondary|TMA Intervention Rate|TMA Intervention Rate (# PE/PI and # Dialysis Events/Patient/Day) in the eculizumab treatment period (from baseline through 26 weeks) for PE/PI and (from the fifteenth day following the first eculizumab dose through 26 weeks) for new dialysis events was compared with the TMA Intervention Rate during the pre-eculizumab treatment period.|Through 26 weeks|A signed rank test assessed differences in magnitudes of change in TMA intervention rate between the pre-eculizumab treatment period and during eculizumab treatment period for ITT population.||#events/patient/day||Standard Deviation|Mean
785595|NCT00838513|Primary|Percentage of Patients With Complete TMA Response|The proportion of patients who achieved a Complete TMA Response from baseline through 26 weeks of treatment with eculizumab was determined. Complete TMA Response was defined as Hematologic Normalization plus improvement in renal function (defined as (≥25% reduction from baseline in serum creatinine), which was sustained for two consecutive measurements over a period of at least four weeks.|Through 26 weeks|Tabulations of the proportion of patients who achieved a complete TMA response from baseline through 26 weeks were performed. For this endpoint, for any relevant proportions, exact binomial 95% confidence intervals were produced.||Percentage of Participants||95% Confidence Interval|Number
785596|NCT00838513|Primary|Percentage of Patients With Hematologic Normalization|Hematologic Normalization was defined as normalization of both platelet count and lactic dehydrogenase (LDH) sustained for at least two consecutive measurements which spanned a period of at least four weeks.|Through 26 weeks|Tabulations of the proportion of patients who achieved a hematologic normalization through 26 weeks were performed for the ITT population. Exact binomial 95% confidence intervals were produced for the analysis.||Percentage of Participants||95% Confidence Interval|Number
785597|NCT00838513|Primary|Percentage of Patients With TMA Event-free Status|TMA Event-free status is defined as the absence for at least 12 weeks of [1] decrease in platelet count of > 25% from the Platelet Count Pre-PT Baseline Set Point; [2] PT while the patient is receiving eculizumab, and [3] new dialysis.|Through 26 weeks|The tabulations of the proportions of patients who achieved a TMA Event-Free status through 26 weeks were performed for the ITT population. Exact binomial 95% confidence intervals were produced for the analysis.||Percentage of Participants||95% Confidence Interval|Number
785598|NCT00838526|Secondary|Secondary Outcome Measures Will Include: Adverse Events, Electrocardiograms (ECGs), Laboratory Evaluations (Hematology, Blood Chemistry, Urinalysis, and Gastrin), Gastric Biopsies, Physical Exam, and Vital Signs.|Information presented within Adverse Event information.|Baseline to Week 26||||||
785599|NCT00838526|Primary|Percentage of Participants With Maintenance of Complete Healing of eGERD at Week 26|"eGERD (erosive gastroesophageal reflux disease) healing measured by the Time-to-Relapse of Oesophageal Erosions using an Esophagogastroduodenoscopy (EGD). Lesions were identified and graded using the following Los Angeles (LA) classification of Oesophagitis: Not Present: No breaks (erosions) in the esophageal mucosa (however, edema, erythema, or friability may be present).
Grade A: One or more mucosal breaks not more than 5mm in maximum length. Grade B: One or more mucosal breaks more than 5mm in maximum length, but not continuous between the tops of 2 mucosal folds.
Grade C: Mucosal breaks continuous between the tops of 2 or more mucosal folds, but involving less than 75% of the esophageal circumference.
Grade D: Mucosal breaks involving at least 75% of the esophageal circumference."|Baseline to Week 26|Intent-to-Treat (ITT) Population - all randomized subjects who received at least 1 dose of study drug.||Percentage of Participants|||Number
785600|NCT00838526|Secondary|Percentage of Participants With Investigator-recorded Sustained Resolution of Heartburn at Week 26|Heartburn or other GERD-associated symptoms (regurgitation, epigastric or chest pain, dysphagia, belching, bloating, early satiety, other) was based on a 4-point Likert scale that included the following: None (No symptoms); Mild (Awareness of symptoms but easily tolerated); Moderate (Discomforting symptom sufficient to cause interference with normal activities including sleep); Severe (Incapacitating symptom, inability to perform normal activities).|Baseline to Week 26|ITT||Percentage of Participants|||Number
785601|NCT00838578|Primary|Number of Participants With Serious and Other (Non-Serious) Adverse Events According to the CTCAE v.3.0||Until disease progression, death, or withdrawal post initial KRN330 treatment, assessed up to 100 months|ITT population||participants|||Number
785602|NCT00838630|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration|Bioequivalence based on AUC0-t|Blood samples collected over 96 hour period|Data from subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
785603|NCT00838630|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 96 hour period|Data from subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
785604|NCT00838630|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 96 hour period|Data from subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
785605|NCT00838682|Other Pre-specified|Duration of Hospital Stay||6wk|intention to treat (ITT)||days||Standard Deviation|Mean
785606|NCT00838682|Other Pre-specified|Mean Units of Blood Transfusion|In order to compare the total amount of blood transfusion, mean units of blood transfusion was used.|day 3|intention to treat (ITT)||Mean units of blood transfusion||Standard Deviation|Mean
785607|NCT00838682|Secondary|Death||6wk|intention to treat (ITT)||participants|||Number
785611|NCT00838903|Secondary|Change From Baseline in Body Weight at Week 156|The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. This analysis used observed body weight values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|Baseline and Week 156|ITT Population with observed values. Only those participants who were available at the indicated time points were analyzed.||Kilograms||Standard Deviation|Mean
785612|NCT00838903|Secondary|Change From Baseline in Body Weight at Week 104|The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The LOCF method was used to impute missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue were treated as missing and replaced with prerescue values. Based on ANCOVA: change = treatment + Baseline weight + Baseline HbA1c category + prior myocardial infarction history + age category + region.|Baseline and Week 104|ITT Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 104.||Kilograms||Standard Error|Least Squares Mean
785613|NCT00838903|Secondary|Time to Hyperglycemia Rescue|Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue.The conditions for hyperglycemic rescue were as follows: FPG >=280 milligrams/deciliter (mg/dL) between >=Week 2 and <Week 4; FPG >=250 mg/dL between >=Week 4 and <Week 12; HbA1c >=8.5% and a <=0.5% reduction from Baseline between >=Week 12 and <Week 24; HbA1c >=8.5% between >=Week 24 and <Week 48; HbA1c >=8.0% between >= Week 48 and <Week 156. Participants could have been rescued at any time on or after Week 2. Time to hyperglycemia rescue is defined as the time between the date of the first dose of study medication and the date of hyperglycemia rescue plus 1 day, or the time between the date of the first dose of study medication and the date of the last visit during the active treatment period plus 1 day for participants not requiring rescue. This time was divided by 7 to express the result in week|From the start of study medication until the end of the treatment (up to Week 156)|ITT Population. Only those participants with a value at Baseline and at the specified visit were analyzed.||Weeks||95% Confidence Interval|Median
785614|NCT00838903|Secondary|Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156|The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <7%, and <7.5% at Week 156) were assessed.|Week 156|ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed.||Participants|||Number
785615|NCT00838903|Secondary|Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 104|The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <7%, and <7.5% at Week 52) were assessed.|Week 104|ITT Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 104.||Participants|||Number
785616|NCT00838903|Secondary|Change From Baseline in FPG at Week 156|The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed FPG values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|Baseline and Week 156|ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed.||Millimoles per liter (mmol/L)||Standard Deviation|Mean
785617|NCT00838903|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 104|The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. The LOCF method was used to impute missing post-Baseline FPG values. FPG values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on ANCOVA: change = treatment + Baseline FPG + Baseline HbA1c category + prior myocardial infarction history + age category + region.|Baseline and Week 104|Intent-to-Treat (ITT) Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 104.||Millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
785618|NCT00838903|Secondary|Change From Baseline in HbA1c at Week 156|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed HbA1c values, excluding those obtained after hyperglycemia rescue; no missing data imputation was performed .|Baseline and Week 156|Intent-to-Treat (ITT) Population with observed values. Only those par. with a value at Baseline and at the specified visit were analyzed.||Percentage of HbA1c in the blood||Standard Deviation|Mean
785619|NCT00838903|Primary|Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 104|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The BL HbA1c value is defined as the last non-missing value before the start of treatment. Change from BL was calculated as the value at Week 104 minus the value at BL. Based on analysis of covariance (ANCOVA): change = treatment + BL HbA1c + prior myocardial infarction history + age category + region. Difference of least squares means (albiglutide – placebo, albiglutide – sitagliptin, albiglutide - glimepiride) is from the ANCOVA model. The last observation carried forward (LOCF) method was used to impute missing post-Baseline HbA1c values; the last non-missing post-BL on-treatment measurement was used to impute the missing measurement. HbA1c values obtained after hyperglycemic rescue were treated as missing and were replaced with pre-rescue values.|Baseline and Week 104|Intent-to-Treat (ITT) Population with LOCF: all randomized par. who received >=1 dose of study medication and who had a BL assessment and >=1 post-BL assessment of HbA1c. Only par. with a value at BL and at the specified visit were analyzed. Values were carried forward for par. who were rescued or discontinued from active treatment before Week 104.||Percentage of HbA1c in the blood||Standard Error|Least Squares Mean
785620|NCT00838916|Secondary|Albiglutide Plasma Concentrations at Week 8 and Week 24|Albiglutide plasma concentration data was analyzed at Week 8 pre-dose, Week 8 post-dose, Week 24 pre-dose and Week 24 post-dose. All participants receiving albiglutide were initiated on a 30 mg weekly dosing regimen; however, beginning at Week 4, uptitration of albiglutide was allowed based on glycemic response. As such, albiglutide plasma concentrations achieved at each sampling time represent a mixed population of participants receiving either 30 mg or 50 mg weekly for various durations.|Weeks 8 and 24|ITT population. Only those participants with a PK sample available for analysis at the indicated time points were analyzed.||nanograms/milliliter (ng/mL)||Standard Deviation|Mean
785621|NCT00838916|Secondary|Change From Baseline in Glucose Profile Measured by 24-hour Area Under Curve (AUC) at Week 52|A 24-hour glucose profile was collected at Baseline and Week 52 at a subset of sites in a subset of participants per treatment group using the continuous glucose monitoring device. Glucose measurements were obtained at 5 minute increments in the 24-hour period. The area under the curve (AUC) was determined using the trapezoidal method on the measurements obtained during the first 24 hours of continuous monitoring. This analysis used observed values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed. The Baseline value is the last non-missing value before the start of treatment.|Baseline and Week 52|Glucose Profile Substudy Population: all participants who participated in the 24-hour glucose profile substudy . Only those participants with a value at Baseline and Week 52 were analyzed.||Millimoles per hour per liter (mmol.h/L)||Standard Deviation|Mean
785622|NCT00838916|Secondary|Change From Baseline in Body Weight at Week 156|The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight.|Baseline and Week 156|ITT Population with observed values. Only those participants who were available at the indicated time points were analyzed. This analysis used observed body weight values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.||Kilograms||Standard Deviation|Mean
785623|NCT00838916|Secondary|Change From Baseline in Body Weight at Week 52|The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The LOCF method was used to impute missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue were treated as missing and replaced with prerescue values. Based on ANCOVA: change = treatment + Baseline weight + Baseline HbA1c category + prior myocardial infarction history + age category + region + current antidiabetic therapy.|Baseline and Week 52|ITT Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 52.||Kilograms||Standard Error|Least Squares Mean
785624|NCT00838916|Secondary|Time to Hyperglycemia Rescue|Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue. The conditions for hyperglycemia rescue were as follows: FPG >=280 milligrams/deciliter (mg/dL) between >=Week 2 and <Week 4; FPG >=250 mg/dL between >=Week 4 and <Week 12; HbA1c >=8.5% and a <=0.5% reduction from Baseline between >=Week 12 and <Week 24; HbA1c >=8.5% between >=Week 24 and <Week 48; HbA1c >=8.0% between >= Week 48 and <Week 156. Participants could have been rescued at any time on or after Week 2. Time to hyperglycemia rescue is defined as the time between the date of the first dose of study medication and the date of hyperglycemia rescue plus 1 day, or the time between the date of the first dose of study medication and the date of the last visit during the active treatment period plus 1 day for participants not requiring rescue. This time was divided by 7 to express the result in weeks.|From the start of study medication until the end of the treatment (up to Week 156)|ITT Population. Only those participants with a value at Baseline and at the specified visit were analyzed.||Weeks||95% Confidence Interval|Median
785625|NCT00838916|Secondary|Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156|The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <7%, and <7.5% at Week 156) were assessed.|Week 156|ITT Population with observed values. Only those par. with a value at Baseline and at the specified visit were analyzed. This analysis used observed HbA1c values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.||Participants|||Number
785626|NCT00838916|Secondary|Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 52|The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <7%, and <7.5% at Week 52) were assessed.|Week 52|ITT Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 52.||Participants|||Number
785627|NCT00838916|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 156|The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Week 156|ITT Population with observed values. Only those par. with a value at Baseline and at the specified visit were analyzed. This analysis used observed FPG values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.||Millimoles per liter (mmol/L)||Standard Deviation|Mean
785628|NCT00838916|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52|The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. The LOCF method was used to impute missing post-Baseline FPG values. FPG values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on ANCOVA: change = treatment + Baseline FPG + Baseline HbA1c category + prior myocardial infarction history + age category + region + current antidiabetic therapy.|Baseline and Week 52|Intent-to-Treat (ITT) Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 52.||Millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
785660|NCT00828984|Secondary|Change in SNAIL Expression as Measured in Endoscopically Normal (Non-ACF) Mucosal Biopsies||6 months - baseline|The study population includes men and women of all races and ethnicities who are scheduled to undergo colonoscopy for a history of colonic neoplasia (within the past 6 years of either colonic adenoma ≥ 5 mm or carcinoma).||ng/ml||Standard Deviation|Mean
785629|NCT00838916|Secondary|Change From Baseline in HbA1c at Week 156|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed HbA1c values, excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|Baseline and Week 156|ITT Population with observed values. Only those par. with a value at Baseline and at the specified visit were analyzed.||Percentage of HbA1c in the blood||Standard Deviation|Mean
785630|NCT00838916|Primary|Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The BL HbA1c value is defined as the last non-missing value before the start of treatment. Change from BL was calculated as the value at Week 52 minus the value at BL. Based on analysis of covariance (ANCOVA): change = treatment + BL HbA1c + prior myocardial infarction history + age category + region + current antidiabetic therapy. Difference of least squares means (albiglutide – insulin glargine) is from the ANCOVA model. The last observation carried forward (LOCF) method was used to impute missing post-Baseline HbA1c values; the last non-missing post-BL on-treatment measurement was used to impute the missing measurement. HbA1c values obtained after hyperglycemic rescue were treated as missing and were replaced with pre-rescue values.|Baseline and Week 52|Intent-to-Treat (ITT) Population with LOCF: all randomized par. who received >=1 dose of study medication and who had a BL assessment and >=1 post-BL assessment of HbA1c. Only par. with a value at BL and at the specified visit were analyzed. Values were carried forward for par. who were rescued or discontinued from active treatment before Week 52.||Percentage of HbA1c in the blood||Standard Error|Least Squares Mean
785631|NCT00838929|Primary|Maximum Tolerated Dose (MTD) and Recommended Phase II Dose (RP2D) of Vorinostat and Radiotherapy in Patients With Brain Metastases.|"To determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of Vorinostat and radiotherapy in patients with brain metastases.
The maximum tolerated dose (MTD) will be one dose below the DLT occurring in at least 1 out of 3 subjects.
Dose level -2: 50 mg PO qd (to be used in de-escalation if toxicity occurs) Dose level -1: 100 mg PO qd (to be used in de-escalation if toxicity occurs) Dose level I: 200 mg PO qd (initial starting dose) Dose level II: 300 mg PO qd Dose level III: 400 mg PO qd"|Weekly during treatment On Last day of treatment (30 days after last drug dose) Follow-up (every 3 months)|||mg|||Number
785632|NCT00838981|Secondary|Average Number of Days Using a Substance Within Treatment||up to 90 days|||days||Standard Deviation|Mean
785633|NCT00838981|Primary|Average Maximum Days Abstinent||up to 84 days|||days||Standard Deviation|Mean
785634|NCT00838981|Primary|Average Number of Positive Urine Tests|thrice weekly urine tests|up to 12 weeks.|||urine tests||Standard Deviation|Mean
785635|NCT00839072|Secondary|Area Under the Concentration-time Curve From 0 to 24 Hours [AUC0-24]||24 hours|The dataset for pharmacokinetic analysis comprised the 20 subjects who completed both study periods.||ng*h/mL||Standard Deviation|Mean
785636|NCT00839072|Secondary|Apparent Terminal Elimination Half-Life [T½el]|The elimination half-life (T½el) of trazodone in plasma (time it takes for the concentration of trazodone to fall to half), expressed in hours.|72 hours post-dose|The dataset for pharmacokinetic analysis comprised the 20 subjects who completed both study periods.||Hours||Standard Deviation|Mean
785637|NCT00839072|Secondary|Time of Maximum Measured Plasma Concentration (Tmax)||72 hours post-dose|The dataset for pharmacokinetic analysis comprised the 20 subjects who completed both study periods.||hours||Full Range|Median
785638|NCT00839072|Primary|Bioequivalence Based on AUC∞|AUC∞ = Area under the concentration-time curve extrapolated to infinity|72 hours post-dose|The dataset for pharmacokinetic analysis comprised the 20 subjects who completed both study periods.||ng*h/mL||Standard Deviation|Mean
785639|NCT00839072|Primary|Bioequivalence Based on AUCT|AUCT = Area under the concentration-time curve from 0 to the time of the last quantifiable concentration|72 hours post-dose|The dataset for pharmacokinetic analysis comprised the 20 subjects who completed both study periods.||ng*h/mL||Standard Deviation|Mean
785640|NCT00839072|Primary|Bioequivalence Based on Cmax|Cmax = Maximum plasma concentration Measured in nanograms per millilitre (ng/mL)|72 hours post-dose|The dataset for pharmacokinetic analysis comprised the 20 subjects who completed both study periods.||ng/mL||Standard Deviation|Mean
785641|NCT00839098|Primary|Wheelchair Occupancy|Wheelchair occupancy was measured by the sum of duration that the seat of the wheelchair was occupied. The results of the difference between the baseline and week 7-8 (last 2 weeks) were shown here.|Every 2 weeks for 8 weeks following acquisition of wheelchair|Only the data of the participants who completed the study protocol and use the wheelchair were included in the data analysis.||hours||Standard Deviation|Mean
785642|NCT00839098|Primary|Power Wheelchair Usage|Power wheelchair usage was measured by the sum of distances that the power wheelchair traveled (km) divided by the duration of the wheelchair being occupied a day (hr). The result of the difference between the baseline and week 7-8 (last 2 weeks) was shown here.|Every 2 weeks for 8 weeks following acquisition of wheelchair|Only the data of the participants who completed the study protocol and use the wheelchair were included in the data analysis.||km/hour||Standard Deviation|Mean
785643|NCT00839098|Primary|Frequency of Power Seat Function Usage|Frequency of power seat function usage was measured by the number of times of changing tilt and recline angles averaged by the duration that the participant occupied the wheelchair per day. The results of the difference between the baseline and week 7-8 (last 2 weeks) were shown here.|Every 2 weeks for 8 weeks following acquisition of wheelchair|Only the data of the participants who completed the study protocol and use the wheelchair were included in the data analysis.||times/hour||Standard Deviation|Mean
785644|NCT00839098|Secondary|Questionnaire Responses: Independence in Community|This outcome was measured in three aspects: Physical Independence, Cognitive Independence, and Mobility, using the three of the subscales of Craig Handicap Assessment and Reporting Technique Scale. The scores of each subscale has to be calculated with specific formula and weight based on the manual. The range of each subscale score are: Physical Independence: 28-100; Cognitive Independence: 15-100; and Mobility: 16-100. A higher score indicates greater independence. The analyzed results of the difference between the measurements at the end of 2nd week and 8th week were shown here.|At the end of 2nd (end of baseline) week and 8th week (end of intervention period) following acquisition of wheelchair|Only the data of the participants who completed the study protocol and use the wheelchair were included in the data analysis.||units on a scale||Standard Deviation|Mean
785645|NCT00839098|Secondary|Questionnaire Responses: Psychological Impacts of Assistive Devices Scale|This tool is to measure perceived psychological impact of using an assistive device. It consists of three subscales, Competence (12 items), Adaptability (6 items), and Self-esteem (8 items). Each item is scored on a likert scale from -3 (decreases) to + 3 (increases). The total score is the sum of all 26 items, ranging from -78 to 78. A higher positive score indicates more positive impact. A negative score indicates negative impact. The differences between the measurements taken at the end of 2nd week (end of baseline) and the end of 8th week (end of intervention period) are reported here to show the intervention effect.|At the end of every two weeks|Only the data of the participants who completed the study protocol and use the wheelchair were included in the data analysis.||units on a scale||Standard Deviation|Mean
785646|NCT00839098|Secondary|Questionnaire Responses: Tool for Assessing Wheelchair Discomfort (TAWC)|General Discomfort Assessment (GD) and Discomfort Intensity Rating (DI) are two sub-scales of TAWC. Higher scores indicate greater discomfort. GD consists of 8 discomfort statements and 5 comfort statements. The statements are rated on a seven point Likert scale, from strongly disagree to strongly agree of points from 1-7 (total score: 13-91). DI includes seven body areas (back, neck, buttocks, legs, arms, feet, and hands) and overall discomfort level, rated for a degree of discomfort intensity on a scale of 0 (no discomfort) to 10 (severe discomfort). Space is also included for the user to list additional body areas. DI scores may range from 0 to more than 80, depending on whether the participant reported additional areas of discomfort. Although GD and DI were measured daily, the data were average for each two-week period. The average GD and DI of the difference between the baseline and week 7-8 (last 2 weeks) were shown here.|Every 2 weeks for 8 weeks following acquisition of wheelchair|||units on a scale||Standard Deviation|Mean
785647|NCT00839098|Primary|Compliance Rate|Compliance rate is a measure of compliance with the recommendation of using powered seating functions (moderate or maximum range of tilt, at least once every hour, for 2 minutes). The participant had to follow the recommended position, duration, and frequency to be considered as compliant and performed successful repositioning exercise. The compliance rate of a participant was the number of successful repositioning exercise divided by the sum of the number of successful repositioning exercise and missed repositioning exercise. The result of the difference between the baseline and week 7-8 (last 2 weeks) was shown here.|Every 2 weeks for 8 weeks following acquisition of wheelchair|Only the data of the participants who completed the study protocol and use the wheelchair were included in the data analysis.||Percentage of participants' compliance||Standard Deviation|Mean
785648|NCT00828945|Primary|Percentage of Participants With Response Achieving Targeted LDL-cholesterol Level at Month 12|Participants with “Yes” or “No” responses to a question which stated “Have you reached your target LDL-cholesterol level?”. LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test.|Month 12|The FAS included all enrolled participants who met all inclusion criteria.||Percentage of participants|||Number
785649|NCT00828945|Primary|Percentage of Participants With Response Achieving Targeted LDL-cholesterol Level at Month 6|Participants with “Yes” or “No” responses to a question which stated “Have you reached your target LDL-cholesterol level?”. LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test.|Month 6|The FAS included all enrolled participants who met all inclusion criteria.||Percentage of participants|||Number
785650|NCT00828945|Primary|Percentage of Participants With Response Achieving Targeted LDL-cholesterol Level at Week 8|Participants with “Yes” or “No” responses to a question which stated “Have you reached your target LDL-cholesterol level?”. LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test.|Week 8|The FAS included all enrolled participants who met all inclusion criteria.||Percentage of participants|||Number
785651|NCT00828945|Primary|Percentage of Participants With LDL Lower Than 2.5 mmol/L at Month 12|LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test.|Month 12|The FAS included all enrolled participants who met all inclusion criteria.||Percentage of participants||95% Confidence Interval|Number
785652|NCT00828945|Primary|Percentage of Participants With LDL Lower Than 2.5 mmol/L at Month 6|LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test.|Month 6|The FAS included all enrolled participants who met all inclusion criteria.||Percentage of participants||95% Confidence Interval|Number
785653|NCT00828945|Primary|Percentage of Participants With LDL Lower Than 2.5 mmol/L at Week 8|LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test.|Week 8|The FAS included all enrolled participants who met all inclusion criteria.||Percentage of participants||95% Confidence Interval|Number
785654|NCT00828945|Primary|Percentage of Participants With Positive Response on Self-estimated Treatment Compliance at Month 12|Participants with “Yes” response to a question which stated “Have you been taking at least 90% of your medication for hyperlipidemia?”.|Month 12|The FAS included all enrolled participants who met all inclusion criteria.||Percentage of participants||95% Confidence Interval|Number
785655|NCT00828945|Primary|Percentage of Participants With Positive Response on Self-estimated Treatment Compliance at Month 6|Participants with “Yes” response to a question which stated “Have you been taking at least 90% of your medication for hyperlipidemia?”.|Month 6|The FAS included all enrolled participants who met all inclusion criteria.||Percentage of participants||95% Confidence Interval|Number
785656|NCT00828945|Primary|Percentage of Participants With Positive Response on Self-estimated Treatment Compliance at Week 8|Participants with “Yes” response to a question which stated “Have you been taking at least 90% of your medication for hyperlipidemia?”.|Week 8|The FAS included all enrolled participants who met all inclusion criteria.||Percentage of participants||95% Confidence Interval|Number
785657|NCT00828945|Primary|Percentage of Participants With Positive Response on Increased Motivation After Awareness at Month 12|Participants with “Yes” response to a question which stated “The awareness of my disease has increased my motivation for taking my medication for hyperlipidemia?”.|Month 12|The FAS included all enrolled participants who met all inclusion criteria.||Percentage of participants||95% Confidence Interval|Number
785658|NCT00828945|Primary|Percentage of Participants With Positive Response on Increased Motivation Using a Self-test at Month 12|Participants with “Yes” response to a question which stated “The self-test have increased my motivation for taking my medication for hyperlipidemia?”. The self test done for assessment of LDL levels using CARE diagnostica LDL-cholesterol test.|Month 12|The Full Analysis Set (FAS) included all enrolled participants who met all inclusion criteria.||Percentage of participants||95% Confidence Interval|Number
785661|NCT00828984|Secondary|Change in Mucosal Apoptosis (Cleaved Caspase-3) as Measured in Endoscopically Normal (Non-ACF) Mucosal Biopsies|Change in activated caspase-3 (apoptosis) expression as measured in endoscopically normal (non-ACF) mucosal biopsies|6 months - baseline|The study population includes men and women of all races and ethnicities who are scheduled to undergo colonoscopy for a history of colonic neoplasia (within the past 6 years of either colonic adenoma ≥ 5 mm or carcinoma).||ng/ml||Standard Deviation|Mean
785662|NCT00828984|Secondary|Change in Ki-67 (Proliferation) Expression as Measured in Endoscopically Normal (Non-ACF) Mucosal Biopsies|To determine the effect of PEG 3350 on mucosal epithelial proliferation (Ki-67)|6 months - baseline|To determine the effect of PEG 3350 on aberrant crypt foci (ACF) number and to compare the reduction in ACF number between the low dose (8g PEG 3350 / day) and higher dose (17g PEG 3350 / day) groups.||ng/ml||Standard Deviation|Mean
785663|NCT00828984|Secondary|Change in ACF Count as Measured in Endoscopically Normal (Non-ACF) Mucosal Biopsies|To determine the effect of PEG 3350 on aberrant crypt foci (ACF) number and to compare the reduction in ACF number between the low dose (8g PEG 3350 / day) and higher dose (17g PEG 3350 / day) groups|6 months - baseline|The study population includes men and women of all races and ethnicities who are scheduled to undergo colonoscopy for a history of colonic neoplasia (within the past 6 years of either colonic adenoma ≥ 5 mm or carcinoma).||Aberrant Crypt Foci||Standard Deviation|Mean
785664|NCT00828984|Primary|Difference (After Treatment Minus Before Treatment) of EGFR Expression|Evaluate the effect of polyethylene glycol (PEG) 3350 (administered at 8g or 17g/day for six months) versus placebo on EGFR expression.|6 months - baseline|The study population includes men and women of all races and ethnicities who are scheduled to undergo colonoscopy for a history of colonic neoplasia (within the past 6 years of either colonic adenoma ≥ 5 mm or carcinoma).||ng/ml||Standard Deviation|Mean
785665|NCT00829010|Secondary|Number of Subjects With Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|From study start at Month 0 (6 weeks of age and above) up to study end at Month 23 (24-27 months of age)|The Total Vaccinated cohort included all subjects with at least one vaccine dose administration documented.||Subjects|||Number
785666|NCT00829010|Secondary|Number of Subjects With Unsolicited AEs.|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within the 31-day (Days 0-30) post Synflorix booster vaccination period|The Total Vaccinated cohort included all subjects with at least one vaccine dose administration documented.||Subjects|||Number
785667|NCT00829010|Secondary|Number of Subjects With Unsolicited AEs.|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within the 31-day (Days 0-30) post-primary vaccination period|The Total Vaccinated cohort included all subjects with at least one vaccine dose administration documented.||Subjects|||Number
785668|NCT00829010|Secondary|Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs).|"Solicited general AEs = drowsiness, irritability, loss of appetite and fever (axillary ≥ 37.5 degrees Celsius). Any= Incidence of any symptom regardless of intensity grade or relationship to vaccination. Grade 3:
drowsiness = prevented normal activity. irritability = crying that could not be comforted/ prevented normal activity. loss of appetite = not eating at all. Fever = temperature > 39.5°C Related = symptom assessed by the investigator as related to the vaccination."|During the 4-day (Days 0-3) period following booster vaccination with Synflorix vaccine|The Total Vaccinated cohort included all subjects who received at least one vaccine dose administration, with analysis done solely on subjects for whom post-vaccination results about solicited symptoms were available.||Subjects|||Number
785669|NCT00829010|Secondary|Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs).|Solicited local AEs assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimetre.|During the 4-day (Days 0-3) period following booster vaccination with Synflorix vaccine|The Total Vaccinated cohort included all subjects who received at least one vaccine dose administration, with analysis done solely on subjects for whom post-vaccination results about solicited symptoms were available.||Subjects|||Number
785670|NCT00829010|Secondary|Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs).|"General AEs = diarrhoea, drowsiness, irritability, loss of appetite, vomiting and fever (axillary ≥ 37.5 degrees Celsius). Any= Incidence of any symptom regardless of intensity grade or relationship to vaccination. Grade 3:
drowsiness = prevented normal activity. irritability = crying that could not be comforted/ prevented normal activity. loss of appetite = not eating at all. diarrhoea: ≥ 6 looser than normal stools/day. vomiting: ≥ 3 episodes of vomiting/day. Fever = > 39.5°C Related = symptom assessed by the investigator as related to the vaccination."|During the 4-day (Days 0-3) post-primary vaccination period across doses|The Total Vaccinated cohort included all subjects who received at least one vaccine dose administration, with analysis done solely on subjects for whom post-vaccination results about solicited symptoms were available.||Subjects|||Number
785671|NCT00829010|Secondary|Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs).|Solicited local AEs assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimetre.|During the 4-day (Days 0-3) post-primary vaccination period across doses|The Total Vaccinated cohort included all subjects who received at least one vaccine dose administration, with analysis done solely on subjects for whom post-vaccination results about solicited symptoms were available.||Subjects|||Number
785740|NCT00829309|Primary|Cmax - Maximum Observed Concentration - Pravastatin in Plasma|Bioequivalence based on Cmax|Blood samples collected over 16 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
785672|NCT00829010|Secondary|Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs|Acquisition of new H. influenza* (HI) and S. pneumonia(SP) strains, identified in the nasopharynx at each swab time point: Month (Mth) 3 (18 weeks of age), Mth 8 (9-10 Months of age), Mth 9 (10-11 Months of age), Mth 11 (12-13 Months of age), Mth 14 (15-18 Months of age), Mth 15 (16-19 Months of age) and Mth 23 (24-27 Months of age). *Data presented included only results from samples confirmed as positive for Hi/Non Typeable Hi after differentiation from H. haemolyticus by PCR assay|up to study end at Month 23 (24-27 months of age)|The Total Vaccinated cohort included all subjects with at least one vaccine dose administration documented||Subjects|||Number
785673|NCT00829010|Secondary|Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx.|Positive cultures of H. influenza* (HI) and S. pneumonia(SP) and other bacterial pathogens such as Moraxella catarrhalis(MC), Group A streptococci and Staphylococcus aureus (SA), identified in the nasopharynx at each swab time point: Month (Mth) 0 (Pre-vaccination time point at 6-12 weeks of age), Mth 3 (18 weeks of age), Mth 8 (9-10 Months of age), Mth 9 (10-11 Months of age), Mth 11 (12-13 Months of age), Mth 14 (15-18 Months of age), Mth 15 (16-19 Months of age) and Mth 23 (24-27 Months of age). *Data presented included only results from samples confirmed as positive for Hi/Non Typeable Hi after differentiation from H. haemolyticus by Polymerase Chain Reaction (PCR) assay|up to study end at Month 23 (24-27 months of age)|The Total Vaccinated cohort included all subjects with at least one vaccine dose administration documented||Swabs|||Number
785674|NCT00829010|Secondary|Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples|Salivary antibodies against selected common bacterial protein antigens. Salivary samples (1.0 mL) were collected by using an Oracol™ device consisting of a sponge (2 cm3) placed on a stick that was used to brush the teeth and gums to absorb the saliva. Salivary samples were sent to RMPRU (or GSK Biologicals’ designated validated laboratory) where the sponge was centrifuged to extract the saliva and that was immediately stored at -70°C. The cut-off of the assay was 2.3 U/mL for anti-LytC IgA and 2.2 U/mL for anti PhtD IgA.|up to study end at Month 23 (24-27 months of age)|The Total Vaccinated cohort included all subjects with at least one vaccine dose administration documented||U/mL||95% Confidence Interval|Geometric Mean
785675|NCT00829010|Secondary|Concentrations of Antibodies Against Measles|Concentrations of antibodies are presented as GMCs expressed as milli-International units per milliliter (mIU/mL).The cut-off of the assay is 150 mIU/mL.|1 month following administration of the 1st and 2nd vaccine dose (at Months 9 and 15)|The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.||mIU/mL||95% Confidence Interval|Geometric Mean
785676|NCT00829010|Secondary|Concentrations of Antibodies Against Rotavirus Immunoglobulin A (Rotavirus IgA), by Rotarix Vaccination Status.|Concentrations of antibodies are presented as GMCs expressed as units per millilitre (U/mL). The cut-off of the assay is 20 U/mL. Data were collected for subjects who received 1, 2 doses or no Rotarix dose during the study.|1 month after the administration of the second vaccine dose (at Month 3)|The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.||U/mL||95% Confidence Interval|Geometric Mean
785677|NCT00829010|Secondary|Concentrations of Antibodies Against Hepatitis B Surface Antigen (HBs) by ELISA.|"Concentrations of antibodies were presented as GMCs expressed as milli-International units per milliliter (mIU/mL). The cut-off of the assay was 10 mIU/mL.
As a decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL), the table showed results following partial or complete retesting/reanalysis"|1 month after the booster dose of DTPw-HBV/Hib vaccine (at Month 15)|The ATP cohort for immunogenicity at 15-18 months included evaluable subjects from the ATP cohort for Immunogenicity who received the DTPw-HBV/Hib vaccine and for whom assay results were available for antibodies against at least 1 vaccine antigen component after this booster dose vaccine.||mIU/mL||95% Confidence Interval|Geometric Mean
785678|NCT00829010|Secondary|Concentrations of Antibodies Against Hepatitis B Surface Antigen (HBs) by ELISA|"Concentrations of antibodies are presented as GMCs expressed as milli-International units per milliliter (mIU/mL). The cut-off of the assay is 10 mIU/mL.
As a decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL), the table showed results following partial or complete retesting/reanalysis"|1 month following primary immunization (at Month 3)|According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.||mIU/mL||95% Confidence Interval|Geometric Mean
785679|NCT00829010|Secondary|Concentrations of Antibodies Against Polyribosyl-ribitol Phosphate (PRP)|Concentrations of antibodies are presented as GMCs expressed as microgram per millilitre (µg/mL). The cut-off of the assay is 0.15 µg/mL.|1 month after the booster vaccination (at Month 15)|The ATP cohort for immunogenicity at 15 -18 months included evaluable subjects from the ATP cohort for Immunogenicity who received the DTPw-HBV/Hib vaccine and for whom assay results were available for antibodies against at least 1 vaccine antigen component after this booster dose vaccine.||µg/mL||95% Confidence Interval|Geometric Mean
785680|NCT00829010|Secondary|Concentrations of Antibodies Against Polyribosyl-ribitol Phosphate (PRP)|Concentrations of antibodies are presented as GMCs expressed as microgram per millilitre (µg/mL). The cut-off of the assay is 0.15 µg/mL.|1 month following primary immunization (at Month 3)|The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.||µg/mL||95% Confidence Interval|Geometric Mean
785759|NCT00829530|Secondary|AUC0-72 (Area Under the Concentration-time Curve From Time Zero to Time of 72 Hours)for Ramiprilat.|Informational comparison of AUC0-72 values for the metabolite Ramiprilat.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
785681|NCT00829010|Secondary|Concentrations of Antibodies Against Bordetella Pertussis (BPT) by ELISA .|Concentrations of antibodies are presented as GMCs expressed as ELISA units per millilitre (EL.U/mL). The cut-off of the assay is 15 EL.U/mL.|1 month after the booster dose of DTPw-HBV/Hib vaccine (at Month 15)|The ATP cohort for immunogenicityat 15-18 months included evaluable subjects from the ATP cohort for Immunogenicity who received the DTPw-HBV/Hib vaccine and for whom assay results were available for antibodies against at least 1 vaccine antigen component after this booster dose vaccine.||EL.U/mL||95% Confidence Interval|Geometric Mean
785682|NCT00829010|Secondary|Concentrations of Antibodies Against Bordetella Pertussis (BPT) by ELISA.|Concentrations of antibodies are presented as GMCs expressed as ELISA units per millilitre (EL.U/mL). The cut-off of the assay is 15 EL.U/mL.|1 month following primary immunization (at Month 3)|The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.||EL.U/mL||95% Confidence Interval|Geometric Mean
785683|NCT00829010|Secondary|Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT).|Concentrations of antibodies are presented as GMCs expressed as International units per millilitre (IU/mL). The cut-off of the assay is 0.1IU/mL.|1 month after the booster dose of DTPw-HBV/Hib vaccine (at Month 15)|The According-To-Protocol cohort for immunogenicity at 15-18 months included evaluable subjects from the ATP cohort for Immunogenicity who received the DTPw-HBV/Hib vaccine and for whom assay results were available for antibodies against at least 1 vaccine antigen component after this booster dose vaccine.||IU/mL||95% Confidence Interval|Geometric Mean
785684|NCT00829010|Secondary|Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT).|Concentrations of antibodies are presented as GMCs expressed as International units per millilitre (IU/mL) The cut-off of the assay is 0.1IU/mL.|1 month following primary immunization (at Month 3)|The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.||IU/mL||95% Confidence Interval|Geometric Mean
785685|NCT00829010|Secondary|Concentrations of Antibodies Against Protein D (PD) by ELISA.|Concentrations of antibodies are presented as GMCs expressed as ELISA units per milliliter (EL.U/mL). The cut-off of the assay was 100 EL.U/mL. Data were collected post-Dose 4 at Month 23 for the HIV+/+, HIV+/- and HIV- (3+1) groups and post-Dose 3 at Month 23 for HIV- (3+0) and HIV- (2+1) groups.|up to study end at Month 23 (24-27 months of age)|The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.||EL.U/mL||95% Confidence Interval|Geometric Mean
785686|NCT00829010|Secondary|Concentrations of Antibodies Against Protein D (PD) by ELISA|Concentrations of antibodies are presented as GMCs expressed as ELISA units per milliliter (EL.U/mL). The cut-off of the assay was 100 EL.U/mL. Data were collected post-Dose 3 at Month 3 and post-Dose 4 at Month 9 for the HIV+/+, HIV+/- and HIV- (3+1) groups,post-Dose 3 at Month 3 and at Month 9 for HIV- (3+0) group, and post-Dose 2 at Month 3 and post-Dose 3 at Month 9 for the HIV- (2+1) Group.|At Month 3 and at Month 9|The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.||EL.U/mL||95% Confidence Interval|Geometric Mean
785687|NCT00829010|Secondary|Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A.|Cross-reactive pneumococcal vaccine serotypes assessed were 6A and 19A. Data were collected post-Dose 4 at Month 23 for the HIV+/+, HIV+/- and HIV- (3+1) groups and post-Dose 3 at Month 23 for HIV- (3+0) and HIV- (2+1) groups. Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results are presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay is an opsonic titer of 8.|up to study end at Month 23 (24-27 months of age)|The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.||Titers||95% Confidence Interval|Geometric Mean
785688|NCT00829010|Secondary|Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A.|Cross-reactive pneumococcal vaccine serotypes assessed were 6A and 19A. Data were collected post-Dose 3 at Month 3 and post-Dose 4 at Month 9 for the HIV+/+, HIV+/- and HIV- (3+1) groups,post-Dose 3 at Month 3 and at Month 9 for HIV- (3+0) group, and post-Dose 2 at Month 3 and post-Dose 3 at Month 9 for the HIV- (2+1) Group. Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results are presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay is an opsonic titer of 8.|At Month 3 and at Month 9|ATP cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.||Titers||95% Confidence Interval|Geometric Mean
785689|NCT00829010|Secondary|Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A.|Concentrations were given in microgram per millilitre (µg/mL) and were expressed in geometric mean antibody concentrations. Cross-reactive pneumococcal vaccine serotypes assessed were 6A and 19A. Data were collected post-Dose 4 at Month 23 for the HIV+/+, HIV+/- and HIV- (3+1) groups and post-Dose 3 at Month 23 for HIV- (3+0) and HIV- (2+1) groups. The cut-off of the assay is 0.05 µg/mL.|up to study end at Month 23 (24-27 months of age)|The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.||µg/mL||95% Confidence Interval|Geometric Mean
785690|NCT00829010|Secondary|Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A.|Concentrations were given in microgram per millilitre (µg/mL) and were expressed in geometric mean antibody concentrations. Cross-reactive pneumococcal vaccine serotypes assessed were 6A and 19A. Data were collected post-Dose 3 at Month 3 and post-Dose 4 at Month 9 for the HIV+/+, HIV+/- and HIV- (3+1) groups,post-Dose 3 at Month 3 and at Month 9 for HIV- (3+0) group, and post-Dose 2 at Month 3 and post-Dose 3 at Month 9 for the HIV- (2+1) Group. The cut-off of the assay is 0.05 µg/mL.|At Month 3 and Month 9|The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.||µg/mL||95% Confidence Interval|Geometric Mean
785691|NCT00829010|Secondary|Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes.|Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Data were collected post-Dose 4 at Month 23 for the HIV+/+, HIV+/- and HIV- (3+1) groups and post-Dose 3 at Month 23 for HIV- (3+0) and HIV- (2+1) groups. Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results are presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay is an opsonic titer of 8.|up to study end at Month 23 (24-27 months of age)|The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.||Titers||95% Confidence Interval|Geometric Mean
785692|NCT00829010|Secondary|Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes.|Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Data were collected post-Dose 3 at Month 3 and post-Dose 4 at Month 9 for the HIV+/+, HIV+/- and HIV- (3+1) groups,post-Dose 3 at Month 3 and at Month 9 for HIV- (3+0) group, and post-Dose 2 at Month 3 and post-Dose 3 at Month 9 for the HIV- (2+1) Group. Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results are presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay is an opsonic titer of 8.|At Month 3 and at Month 9|The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.||Titers||95% Confidence Interval|Geometric Mean
785693|NCT00829010|Secondary|Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.|Concentrations were given in microgram per millilitre (µg/mL) and were expressed in geometric mean antibody concentrations. Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Data were collected post-Dose 4 at Month 23 for the HIV+/+, HIV+/- and HIV- (3+1) groups and post-Dose 3 at Month 23 for HIV- (3+0) and HIV- (2+1) groups. The cut-off of the assay is 0.05 µg/mL.|up to study end at Month 23 (24-27 months of age)|The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.||µg/mL||95% Confidence Interval|Geometric Mean
785694|NCT00829010|Secondary|Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.|Concentrations were given in microgram per millilitre (µg/mL) and were expressed in geometric mean antibody concentrations. Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Data were collected post-Dose 3 at Month 3 and post-Dose 4 at Month 9 for the HIV+/+, HIV+/- and HIV- (3+1) groups, post-Dose 3 at Month 3 and at Month 9 for HIV- (3+0) group, and post-Dose 2 at Month 3 and post-Dose 3 at Month 9 for the HIV- (2+1) Group. The cut-off of the assay is 0.05 µg/mL.|At Month 3 and Month 9|The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.||µg/ml||95% Confidence Interval|Geometric Mean
785695|NCT00829010|Primary|Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL).|Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.|1 month following primary immunization (post-Dose 3 at Month 3 for the HIV+/+ Group, HIV+/- Group, HIV- (3+1) Group, HIV- (3+0) Group and post-Dose 2 at Month 3 for the HIV- (2+1) Group)|The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.||Subjects|||Number
785696|NCT00829036|Primary|Mean Percent (Prototype / Baseline) Time|The outcome measure for each subject is the mean of the (Prototype Time / Baseline Time) across 12 trials. The outcome measure for the experiment is the mean of 24 individual subject mean scores. This mean outcome measure is expressed as a percentage of the mean Baseline Time, where improved performance is represented by a percentage that is less than 100 percent of the Baseline Time. The lower the percentage, the better the performance improvement.|2 hours|Power Analysis: Using Repeated Measures ANOVA for the 24 participants assuming a minimum correlation between repeated measures of .7, we chose our analyses will be sensitive to a medium between factor effect size of f=.33 with power set to .80 and alpha level set to .05.||Percentage of Baseline Performance Time||Standard Deviation|Mean
785697|NCT00829049|Secondary|Median Percent Change From Baseline in Inflammatory Lesion Counts (Papules/Pustules, Nodules) at Week 16|Median percent change from baseline in inflammatory lesion counts (papules/pustules, nodules) at Week 16. Papules and nodules are round, solid elevations of the skin with no visible fluid; papules are smaller (less than 5 to 10 millimeters in width and depth) and nodules are larger (greater than 5 to 10 millimeters in width and depth). Pustules are small elevations of the skin containing cloudy material. A negative number change from baseline indicates a reduction in lesion counts (improvement).|Baseline, Week 16|Intent to Treat population included all randomized patients. The number of patients that were analyzed reflects the actual number of patients for which data were available for this outcome measure.||Percent Change||Full Range|Median
785698|NCT00829049|Secondary|Percentage of Patients With >= 2 Grade Improvement in the Overall Disease Severity Score at Week 12|Percentage of patients with >= 2 grade improvement (decrease in score) in the overall disease severity score at Week 12. The overall disease severity score was evaluated by the investigator using a 7-point scale to rate the overall acne severity (lesions, inflammation, facial redness, and skin condition), where 0=no acne lesions and 6=most severe acne.|Week 12|Intent to Treat population included all randomized patients. The number of patients that were analyzed reflects the actual number of patients for which data were available for this outcome measure.||Percentage of patients|||Number
785699|NCT00829049|Secondary|Percentage of Patients With >= 1 Grade Improvement in the Investigator Global Assessment at Week 16|Percentage of patients with >= 1 grade improvement (decrease in score) in the Investigator Global Assessment (IGA) at Week 16. The IGA is a 5-point scale used by the investigator to assess overall acne severity, where 0 equals clear skin (no evidence of acne) and 4 equals severe acne.|Week 16|Intent to Treat population included all randomized patients. The number of patients that were analyzed reflects the actual number of patients for which data were available for this outcome measure.||Percentage of patients|||Number
785700|NCT00829049|Primary|Median Percent Change From Baseline in the Non-Inflammatory Lesion Counts (Open and Closed Comedones) at Week 12|Median percent change from baseline in the non-inflammatory lesion counts (open and closed comedones) at Week 12. Comedones are small bumps on the skin (lesions) caused by acne and found at the opening of a skin pore. Open comedones (also known as blackheads) have a microscopic opening to the skin surface, while closed comedones (also known as whiteheads or pimples) lack the opening to the skin. A negative number change from baseline indicates a reduction in lesion counts(improvement).|Baseline, Week 12|Intent to Treat population included all randomized patients. The number of patients that were analyzed reflects the actual number of patients for which data were available for this outcome measure.||Percent Change||Full Range|Median
785701|NCT00829166|Secondary|Time to Symptom Progression|"Time to symptom progression was defined as the time from randomization to the first documentation of a >/= 5-point decrease from baseline in the scoring of responses as measured by the FACT-B questionnaire with the TOI-PFB subscale. The FACT-B TOI-PFB subscale contained 24 items from 3 subsections of the FACT-B questionnaire: Physical well-being, functional well-being, and additional concerns for breast cancer participants (BCS). All items in the questionnaire were rated by the participant on a 5-point scale ranging from 0 (not at all) to 4 (very much). The total score ranged from 0 to 96 with higher score indicating better perceived quality of life. The median time to symptom progression was estimated using Kaplan-Meier method. The 95% CI was computed using the method of Brookmeyer and Crowley."|From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)|ITT population included all randomized participants on the basis of the treatment assigned at randomization. Only female participants with a Baseline assessment and at least 1 follow-up assessment were included in the analysis.||Months||95% Confidence Interval|Median
785702|NCT00829166|Secondary|Percentage of Participants With Symptom Progression|"Symptom progression was defined as the documentation of a >/= 5-point decrease from baseline in the scoring of responses as measured by the Functional Assessment of Cancer Therapy-for participants with Breast Cancer (FACT-B) questionnaire with the Trial Outcomes Index-Physical/Functional/Breast (TOI-PFB) subscale. The FACT-B TOI-PFB subscale contained 24 items from 3 subsections of the FACT-B questionnaire: Physical well-being, functional well-being, and additional concerns for breast cancer participants (breast cancer subscale [BCS]). All items in the questionnaire were rated by the participant on a 5-point scale ranging from 0 (not at all) to 4 (very much). The total score ranged from 0 to 96 with higher score indicating better perceived quality of life. The percentage of participants with symptom progression was reported."|From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)|ITT population included all randomized participants on the basis of the treatment assigned at randomization. Only female participants with a Baseline assessment and at least 1 follow-up assessment were included in the analysis.||percentage of participants|||Number
785703|NCT00829166|Secondary|Time to Treatment Failure|"Time to treatment failure was defined as the time from randomization to discontinuation of treatment for any reason, including PD (per investigator review), treatment toxicity, or death from any cause. For Lapatinib + Capecitabine arm, a participant was considered as treatment failure only if both drugs were discontinued with treatment failure date as the later of the 2 discontinuation dates. For TLs, PD was defined as >/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions. For non-TLs, PD was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. The median time to treatment failure was estimated using Kaplan-Meier method. The 95% CI was computed using the method of Brookmeyer and Crowley."|From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)|ITT population included all randomized participants on the basis of the treatment assigned at randomization.||Months||95% Confidence Interval|Median
785704|NCT00829166|Secondary|Percentage of Participants With Treatment Failure|"Treatment failure was defined as discontinuation of treatment for any reason, including PD (per investigator review), treatment toxicity, or death from any cause. For Lapatinib + Capecitabine arm, a participant was considered as treatment failure only if both drugs were discontinued. For TLs, PD was defined as >/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions. For non-TLs, PD was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. Percentage of participants with treatment failure was reported."|From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)|ITT population included all randomized participants on the basis of the treatment assigned at randomization.||percentage of participants|||Number
785713|NCT00829166|Primary|Percentage of Participants Who Died: Final Analysis|The percentage of participants who died from any cause was reported. The results reported are from the final analysis. The final analysis is descriptive.|From the date of randomization through the data cut-off date of 31 Dec 2014 (up to 5 years, 11 months)|ITT population included all randomized participants on the basis of the treatment assigned at randomization.||percentage of participants|||Number
785760|NCT00829530|Secondary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)for Ramiprilat.|Informational comparison of Cmax values for the metabolite Ramiprilat.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg/mL||Standard Deviation|Mean
785705|NCT00829166|Secondary|Percentage of Participants With Clinical Benefit as Assessed by an IRC|Tumor response was assessed by an IRC according to modified RECIST. Participants were considered as experienced clinical benefit if they had an OR or maintained stable disease (SD) for at least 6 months from randomization. OR: CR or PR determined on 2 consecutive tumor assessments >/=4 weeks apart. For TLs, CR: disappearance of all TLs; PR: >/=30% decrease in the SLD of TLs, taking as reference the baseline SLD; PD: >/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or appearance of 1 or more new lesions; and SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. For non-TLs, CR: disappearance of all non-TLs; PR/SD: persistence of 1 or more non-TLs; and PD: appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. Participants without a post-baseline tumor assessment were considered non-responders. The 95% CI was computed using Blyth-Still Casella exact CI method.|From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)|ITT population included all randomized participants on the basis of the treatment assigned at randomization. Only participants with measurable disease at Baseline were included in the analysis.||percentage of participants||95% Confidence Interval|Number
785706|NCT00829166|Secondary|Duration of Objective Response (DOR) as Assessed by an IRC|Tumor response was assessed by an IRC according to modified RECIST. DOR was defined as the time from first documented OR to first documented PD or death from any cause, whichever occurred earlier. OR was defined as a CR or PR determined on 2 consecutive tumor assessments at least 4 weeks apart. For TLs, CR was defined as the disappearance of all TLs; PR was defined as >/=30% decrease in the SLD of TLs, taking as reference the baseline SLD; and PD was defined as >/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions. For non-TLs, CR was defined as the disappearance of all non-TLs; PR was defined as the persistence of 1 or more non-TLs; and PD was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. The 95% CI was computed using the method of Brookmeyer and Crowley.|From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)|ITT population included all randomized participants on the basis of the treatment assigned at randomization. Only participants with an objective response were included in the analysis.||Months||95% Confidence Interval|Median
785707|NCT00829166|Secondary|Percentage of Participants With Objective Response (OR) as Assessed by an IRC|Tumor response was assessed by an IRC according to modified RECIST. OR was defined as the percentage of participants with a complete response (CR) or partial response (PR). All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as TLs and recorded at baseline. A sum of the longest diameter for all TLs was calculated as baseline SLD. For TLs, a CR was defined as the disappearance of all TLs and a PR was defined as >/= 30% decrease in the SLD of TLs, taking as reference the baseline SLD. For non-TLs, a CR was defined as the disappearance of all non-TLs and a PR was defined as the persistence of 1 or more non-TLs. Confirmation of response at a consecutive tumor assessment at least 4 weeks apart was required. Participants without a post-baseline tumor assessment were considered non-responders. The percentage of participants with CR or PR by IRC was reported. The 95% CI was computed using Blyth-Still Casella exact CI method.|From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)|ITT population included all randomized participants on the basis of the treatment assigned at randomization. Only participants with measurable disease at baseline were included in the analysis.||percentage of participants||95% Confidence Interval|Number
785708|NCT00829166|Secondary|PFS as Assessed by the Investigator|Tumor response was assessed by the investigator according to modified RECIST. All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as TLs and recorded at baseline. A sum of the longest diameter for all TLs was calculated as baseline SLD. PD for TLs was defined as >/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions. PD for non-TLs was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. PFS was defined as the time from randomization to first documented PD by Investigator or death from any cause (whichever occurred earlier). The median duration of PFS was estimated using Kaplan-Meier method. The 95% CI was computed using the method of Brookmeyer and Crowley.|From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)|ITT population included all randomized participants on the basis of the treatment assigned at randomization.||Months||95% Confidence Interval|Median
785709|NCT00829166|Secondary|Percentage of Participants With PD or Death as Assessed by the Investigator|PD was assessed by the investigator using modified RECIST. All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as TLs and recorded at baseline. A sum of the longest diameter for all TLs was calculated as baseline SLD. PD for TLs was defined as >/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions. PD for non-TLs was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. The percentage of participants who died or experienced PD by Investigator was reported.|From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)|ITT population included all randomized participants on the basis of the treatment assigned at randomization.||percentage of participants|||Number
785710|NCT00829166|Primary|Percentage of Participants Who Were Alive at Year 2|2 year survival was defined as the percentage of participants alive 2 years after starting treatment. The results reported are from the final analysis.|Year 2|ITT population included all randomized participants on the basis of the treatment assigned at randomization.||percentage of participants||95% Confidence Interval|Number
785711|NCT00829166|Primary|Percentage of Participants Who Were Alive at Year 1|1 year survival was defined as the percentage of participants alive 1 year after starting treatment. The results reported are from the final analysis.|Year 1|ITT population included all randomized participants on the basis of the treatment assigned at randomization.||percentage of participants||95% Confidence Interval|Number
785712|NCT00829166|Primary|Overall Survival: Final Analysis|OS was defined as the time from the date of randomization to the date of death from any cause. The median duration of OS was estimated using Kaplan-Meier method. The 95% CI was computed using the method of Brookmeyer and Crowley. The results reported are from the final analysis. The final analysis is descriptive.|From the date of randomization through the data cut-off date of 31 Dec 2014 (up to 5 years, 11 months)|ITT population included all randomized participants on the basis of the treatment assigned at randomization.||Months||95% Confidence Interval|Median
785714|NCT00829166|Primary|Overall Survival: Second Interim Analysis (Co-primary Endpoint)|OS was defined as the time from the date of randomization to the date of death from any cause. The median duration of OS was estimated using Kaplan-Meier method. The 95% CI was computed using the method of Brookmeyer and Crowley. The results are reported from second interim analysis, which deemed to be the confirmatory.|From the date of randomization through the data cut-off date of 31 Jul 2012 (up to 3 years, 5 months)|ITT population included all randomized participants on the basis of the treatment assigned at randomization.||Months||95% Confidence Interval|Median
785715|NCT00829166|Primary|Percentage of Participants Who Died: Second Interim Analysis|The percentage of participants who died from any cause was reported. The results are reported from second interim analysis, which deemed to be the confirmatory.|From the date of randomization through the data cut-off date of 31 Jul 2012 (up to 3 years, 5 months)|ITT population included all randomized participants on the basis of the treatment assigned at randomization.||percentage of participants|||Number
785716|NCT00829166|Primary|Progression-free Survival (PFS) as Assessed by an IRC (Co-primary Endpoint)|Tumor response was assessed by an IRC according to modified RECIST. All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as TLs (on the basis of their size and their suitability for accurate repeated measurements either by imaging or clinically) and recorded at baseline. A sum of the longest diameter for all TLs was calculated as baseline SLD. All other lesions were identified as non-TLs and recorded at baseline. PD for TLs: >/= 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or appearance of 1 or more new lesions. PD for non-TLs: appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. PFS: time from randomization to first documented PD by IRC or death from any cause (whichever occurred earlier). The median duration of PFS was estimated using Kaplan-Meier method. The 95% confidence interval (CI) was computed using the method of Brookmeyer and Crowley.|From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)|ITT population included all randomized participants on the basis of the treatment assigned at randomization.||Months||95% Confidence Interval|Median
785717|NCT00829166|Primary|Percentage of Participants With PD or Death as Assessed by an Independent Review Committee (IRC)|PD was assessed by an IRC using modified Response Evaluation Criteria in Solid Tumors (RECIST). All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as target lesions (TLs) and recorded at baseline. TLs should be selected on the basis of their size (those with the longest diameter) and their suitability for accurate repeated measurements either by imaging or clinically. A sum of the longest diameter for all TLs was calculated as baseline sum longest diameter (SLD). All other lesions (or sites of disease) should be identified as non-TLs and recorded at baseline. PD for TLs was defined as greater than or equal to (>/=) 20 percent (%) increase in SLD, taking as reference smallest SLD recorded since treatment started or appearance of 1 or more new lesions. PD for non-TLs was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. Percentage of Participants with PD by IRC or death from any cause was reported.|From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)|ITT population included all randomized participants on the basis of the treatment assigned at randomization.||percentage of participants|||Number
785718|NCT00829179|Primary|Change in Exhaled Nitric Oxide From Baseline to Week 12|The primary outcome measure was the change in exhaled nitric oxide levels between baseline and week 12. 12 week value minus baseline value. (Baseline was -1 week, ie 1 week prior to the start of study drug)|13 weeks|||parts per billion (ppb)||Standard Deviation|Mean
785719|NCT00829244|Secondary|Pregnancy Outcome - Number of Participants With Pregnancy and Their Outcome|Pregnancy outcomes are live outcome (live infant) and non-live outcome (non-live infant) or unknown outcome (subject lost to follow-up).|up to 9 month (following the end of treatment)|The modified ITT population included all participants randomized into trial who received at least 1 dose of GONAL-f®, and who completed primary efficacy assessment (total number of oocytes retrieved per participant following GONAL-f® stimulation and hCG injection). Participants were analyzed based on treatment they received.||participants|||Number
785720|NCT00829244|Secondary|Number of Participants With OHSS|OHSS is a syndrome which can manifest with enlarged ovaries, advanced ascites with increased vascular permeability, pleural fluid accumulation, hemoconcentration, and increased blood clotting.|Start of treatment until Day 15-20 Post-hCG|Safety population included all the participants who were randomized.||participants|||Number
785721|NCT00829244|Secondary|Percentage of Participants With Clinical Pregnancy|Clinical pregnancy is defined by the number of sacs and hearts with activity per ultrasound scan performed on Day 35-42 post-hCG.|Day 35-42 Post-hCG|The modified ITT population included all participants randomized into trial who received at least 1 dose of GONAL-f®, and who completed primary efficacy assessment (total number of oocytes retrieved per participant following GONAL-f® stimulation and hCG injection). Participants were analyzed based on treatment they received.||percentage of participants|||Number
785722|NCT00829244|Secondary|Serum Progesterone (P4) Levels||End of stimulation cycle (approximately 28 days)|The modified ITT population included all participants randomized into trial who received at least 1 dose of GONAL-f®, and who completed primary efficacy assessment (total number of oocytes retrieved per participant following GONAL-f® stimulation and hCG injection). Participants were analyzed based on treatment they received.||nmol/L||Standard Deviation|Mean
785723|NCT00829244|Secondary|Number of Participants With Multiple Pregnancies|Multiple pregnancy was defined as 2 or more fetal hearts with activity.|Day 35-42 Post-hCG|The modified ITT population. Number of participants analyzed (N) signifies those participants who were evaluated for this outcome measure.||participants|||Number
785724|NCT00829244|Secondary|Implantation Rate|Implantation rate was measured as the number of gestational sacs observed divided by the number of embryos transferred multiplied by 100.|Day 35-42 Post-hCG|The modified ITT population included all participants randomized into trial who received at least 1 dose of GONAL-f®, and who completed primary efficacy assessment (total number of oocytes retrieved per participant following GONAL-f® stimulation and hCG injection). Participants were analyzed based on treatment they received.||percent sacs per embryo||Standard Deviation|Mean
785739|NCT00829309|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 16 hour period|Data from all subjects who completed the study were included in the statistical analysis. Data from one subject could not be included in the AUC0-inf calculation for Pravachol®.||ng*h/mL||Standard Deviation|Mean
785725|NCT00829244|Secondary|Number of Participants With Fetal Sacs and Fetal Hearts|Number of participants with fetal sacs and fetal hearts (with activity) as seen on an ultrasound scan to confirm clinical pregnancy.|Day 35-42 Post-hCG|The modified ITT population included all participants randomized into trial who received at least 1 dose of GONAL-f®, and who completed primary efficacy assessment (total number of oocytes retrieved per participant following GONAL-f® stimulation and hCG injection). Participants were analyzed based on treatment they received.||participants|||Number
785726|NCT00829244|Secondary|Percentage of Participants With Biochemical Pregnancies|Biochemical pregnancy was defined as a pregnancy diagnosed only by the detection of hCG in serum and that does not develop into a clinical pregnancy.|Start of treatment until Day 15-20 Post-hCG|The modified ITT population included all participants randomized into trial who received at least 1 dose of GONAL-f®, and who completed primary efficacy assessment (total number of oocytes retrieved per participant following GONAL-f® stimulation and hCG injection). Participants were analyzed based on treatment they received.||percentage of participants|||Number
785727|NCT00829244|Secondary|Number of Participants With Cancelled Cycles Due to Excessive or Inadequate Response to Treatment|Number of participants with cancelled cycles due to excessive or inadequate response was evaluated. An excessive response: greater than or equal to 25 oocytes which could put the participant at risk of OHSS; An inadequate response: defined as 3 or less follicles of greater than or equal to 12 millimeter (mm) developing following at least 7 days of GONAL-f® treatment.|Start of treatment until Day 15-20 post-hCG|All the randomized participants were analyzed for this outcome measure (N=200).||Participants|||Number
785728|NCT00829244|Secondary|Total Number of GONAL-f® Stimulation Treatment Days||Start of treatment until end of stimulation cycle (approximately 28 days)|The modified ITT population included all participants randomized into trial who received at least 1 dose of GONAL-f®, and who completed primary efficacy assessment (total number of oocytes retrieved per participant following GONAL-f® stimulation and hCG injection). Participants were analyzed based on treatment they received.||days||Standard Deviation|Mean
785729|NCT00829244|Secondary|Mean GONAL-f® Daily Dose||Start of treatment until end of stimulation cycle (approximately 28 days)|The modified ITT population included all participants randomized into trial who received at least 1 dose of GONAL-f®, and who completed primary efficacy assessment (total number of oocytes retrieved per participant following GONAL-f® stimulation and hCG injection). Participants were analyzed based on treatment they received.||IU||Standard Deviation|Mean
785730|NCT00829244|Secondary|Total GONAL-f® Dose||Start of treatment until end of stimulation cycle (approximately 28 days)|The modified ITT population included all participants randomized into trial who received at least 1 dose of GONAL-f®, and who completed primary efficacy assessment (total number of oocytes retrieved per participant following GONAL-f® stimulation and hCG injection). Participants were analyzed based on treatment they received.||IU||Standard Deviation|Mean
785731|NCT00829244|Primary|Number of Oocytes Retrieved Per Participant|Mean number of oocytes retrieved on the day of ovum pick up (OPU) was calculated. Oocyte retrieval is a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body.|34-38 hours post-recombinant human choriogonadotropin (hCG) (OPU)|The modified Intention-To-Treat (ITT) population included all participants randomized into trial who received at least 1 dose of GONAL-f®, and who completed primary efficacy assessment (total number of oocytes retrieved per participant following GONAL-f® stimulation and hCG injection). Participants were analyzed based on treatment they received.||oocytes||Standard Deviation|Mean
785732|NCT00829283|Secondary|BMI|The body mass index is a value derived from the mass and height of an individual. The BMI is defined as the body mass divided by the square of the body height, and is universally expressed in units of kg/m^2.|12 months follow-up post-treatment|||kg/m^2||Standard Deviation|Mean
785733|NCT00829283|Primary|Number of Subjects Who Reached Binge Eating Remission|Binge Remission (abstinence from binge eating)|12 months follow-up|||participants|||Number
785734|NCT00829296|Secondary|Change in Pulse Pressure Amplification|To examine the effect of nebivolol versus metoprolol succinate in Type 2 hypertensive diabetic patients on other measures of central conduit artery function such as pulse pressure amplification (central pulse pressure /brachial pulse pressure).|Baseline and 26 Weeks|Nine patients (4 in the Metoprolol and 5 in the Nebivolol group) discontinued the study medications early in the 26-week follow-up and did not undergo final assessment. Given that our interest was on efficacy, thus, results were reported only on those 61 patients (32 in the Metoprolol and 29 in the Nebivolol group) who completed the study.||ratio||Standard Deviation|Mean
785735|NCT00829296|Secondary|Change in Augmentation Index|Augmentation index is defined as the percentage of the central pulse pressure which is attributed to the reflected pulse wave and, therefore, reflects the degree to which central arterial pressure is augmented by wave reflection.|Baseline and 26 Weeks|Nine patients (4 in the Metoprolol and 5 in the Nebivolol group) discontinued the study medications early in the 26-week follow-up and did not undergo final assessment. Given that our interest was on efficacy, thus, results were reported only on those 61 patients (32 in the Metoprolol and 29 in the Nebivolol group) who completed the study.||percent (%)||Standard Deviation|Mean
785736|NCT00829296|Secondary|Change in Pulse Wave Velocity (PWV)|To examine the effect of nebivolol versus metoprolol succinate in Type 2 hypertensive diabetic patients on other measures of central conduit artery function such as pulse wave velocity.|Baseline and 26 Weeks|Nine patients (4 in the Metoprolol and 5 in the Nebivolol group) discontinued the study medications early in the 26-week follow-up and did not undergo final assessment. Given that our interest was on efficacy, thus, results were reported only on those 61 patients (32 in the Metoprolol and 29 in the Nebivolol group) who completed the study.||m/s||Standard Deviation|Mean
785737|NCT00829296|Primary|Change in Central Systolic Blood Pressure (SBP)|Changes in aortic impedance in patients on nebivolol vs. metoprolol succinate in Type 2 hypertensive diabetic patients as measured by the change from baseline in central systolic blood pressure.|Baseline and 26 Weeks|Nine patients (4 in the Metoprolol and 5 in the Nebivolol group) discontinued the study medications early in the 26-week follow-up and did not undergo final assessment. Given that our interest was on efficacy, thus, results were reported only on those 61 patients (32 in the Metoprolol and 29 in the Nebivolol group) who completed the study.||mmHg||Standard Deviation|Mean
785738|NCT00829309|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 16 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
785741|NCT00829387|Secondary|Beck Depression Inventory (BDI)|"Estimated mean change in depressive symptoms from baseline to 36 weeks post-baseline comparing CBT to Education.
0 (do not endorse) to 3 (highly endorse). no/minimal depressive symptoms =<10; mild-moderate depressive symptoms = 10-18; moderate-severe depressive symptoms = 19-29 severe depressive symptoms = 30-63. The higher the score, the more depressive symptoms endorsed"|baseline to 36 weeks post-baseline [follow-up]|Not everyone that has baseline data completed 36 week post treatment data; making the number of participants analyzed different than reported for baseline data only.||units on a scale||95% Confidence Interval|Mean
785742|NCT00829387|Secondary|The Interference Subscale of the Multidimensional Pain Inventory (MPI)|"Secondary outcome is the estimated mean change in pain interference from baseline to 36 weeks post-baseline comparing CBT to Education.
Pain Interference at the time of assessment; 0 = no interference to 6 = extreme interference. The higher the average number calculated for the subscale, the higher the perceived interference pain has on vocational, social/recreational, and family/martital functioning."|baseline to 36 weeks post-baseline [follow-up]|Not everyone that has baseline data completed 36-week follow up treatment data; making the number of participants analyzed different than reported for baseline data only.||units on a scale||95% Confidence Interval|Mean
785743|NCT00829387|Primary|Numeric Rating Scale (NRS) Pain Intensity|"Primary outcome is the estimated mean change in pain intensity ratings from baseline to 36 weeks post-baseline comparing CBT and Educational arms
Average pain intensity rating over the last 7 days; 0 (no pain at all) to 10 (worst pain imaginable); the higher the number, the greater percieved pain intensity."|baseline to 36 weeks post-baseline [follow-up]|Not everyone that has baseline data completed 36-week follow up treatment data; making the number of participants analyzed different than reported for baseline data only.||units on a scale||95% Confidence Interval|Mean
785744|NCT00829387|Secondary|Beck Depression Inventory (BDI)|"Estimated mean change in depressive symptoms from baseline to 12 weeks post-baseline combaring CBT and ED.
0 (do not endorse) to 3 (highly endorse). no/minimal depressive symptoms =<10; mild-moderate depressive symptoms = 10-18; moderate-severe depressive symptoms = 19-29 severe depressive symptoms = 30-63. The higher the score, the more depressive symptoms endorsed."|baseline to 12 weeks post-baseline [post-treatment]|Not everyone that has baseline data completed 12-week post treatment; making the number of participants analyzed differant than reported for baseline data only.||units on a scale||95% Confidence Interval|Mean
785745|NCT00829387|Secondary|The Interference Subscale of the Multidimensional Pain Inventory (MPI)|"Secondary outcome is the estimated mean change in pain interference from baseline to 12 weeks post-baseline comparing CBT to Education.
Pain Interference at the time of assessment; 0 = no interference to 6 = extreme interference. The higher the average number calculated for the subscale, the higher the perceived interference pain has on vocational, social/recreational, and family/martital functioning."|baseline to 12 weeks post-baseline [post-treatment]|Not everyone that has baseline data completed 12-week post treatment data; making the number of participants analyzed different than reported for baseline data only.||units on a scale||95% Confidence Interval|Mean
785746|NCT00829387|Primary|Numeric Rating Scale (NRS) Pain Intensity|"Primary outcome is the estimated mean change in pain intensity ratings from baseline to 12 weeks post-baseline comparing CBT and Educational arms
Average pain intensity rating over the last 7 days; 0 (no pain at all) to 10 (worst pain imaginable). The higher the score, the more perceived pain a participant reported."|baseline to 12 weeks post-baseline [post-treatment]|Not everyone that completed baseline data completed 12 week post treatment assessments; making the number of participants analyzed different than reported for baseline data only.||units on a scale||95% Confidence Interval|Mean
785747|NCT00829426|Primary|Bioequivalence Based on AUC0-t|AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration|Blood samples collected over 72 hour period|||ng*h/mL||Standard Deviation|Mean
785748|NCT00829426|Primary|Bioequivalence Based on AUC0-inf|AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)|Blood samples collected over 72 hour period|||ng*h/mL||Standard Deviation|Mean
785749|NCT00829426|Primary|Bioequivalence Based on Cmax|Cmax - Maximum Observed Concentration|Blood samples collected over 72 hour period|||ng/mL||Standard Deviation|Mean
785750|NCT00829439|Primary|Maximum Dose of Levodopa/Carbidopa That Can be Tolerated (Without Any Dose Limiting Toxicity) by at Least 3 Subjects.||1 week|||mg/kg/day|||Number
785751|NCT00829452|Secondary|AUC0-72 (Area Under the Concentration-time Curve From Time Zero to Time of 72 Hours) for Ramiprilat.|Informational comparison of AUc0-72 values for the metabolite Ramiprilat.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
785752|NCT00829452|Secondary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)for Ramiprilat.|Informational comparison of Cmax values for the metabolite Ramiprilat.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg/mL||Standard Deviation|Mean
785753|NCT00829452|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) for Ramipril.|Bioequivalence based on AUC0-inf.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
785754|NCT00829452|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) for Ramipril.|Bioequivalence based on AUC0-t.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
785755|NCT00829452|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)for Ramipril.|Bioequivalence based on Cmax.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg/mL||Standard Deviation|Mean
785756|NCT00829504|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
785757|NCT00829504|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
785758|NCT00829504|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Cmax.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed.||pg/mL||Standard Deviation|Mean
785761|NCT00829530|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)for Ramipril.|Bioequivalence based on AUC0-inf.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
785762|NCT00829530|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)for Ramipril.|Bioequivalence based on AUC0-t.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
785763|NCT00829530|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)for Ramipril.|Bioequivalence based on Cmax.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg/mL||Standard Deviation|Mean
785764|NCT00829621|Primary|Presence of BMP-2 in Effluent Collected in IVAC Canister|Presence of BMP-2 in effluent collected in IVAC canister|12-hours, 24-hours, 36-hours, and 48-hours after IVAC application|||participants|||Number
785765|NCT00829673|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 16 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
785766|NCT00829673|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 16 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
785767|NCT00829673|Primary|Cmax (Maximum Observed Concentration)|Bioequivalence based on Cmax.|Blood samples collected over a 16 hour period.|All participants that completed the study had their samples analyzed.||pg/mL||Standard Deviation|Mean
785768|NCT00829686|Secondary|Recurrence Rates|recurrence of abscess in previous or new location within 30 days|30 days|||participants|||Number
785769|NCT00829686|Primary|Clinical Improvement at 7 Days After Incision and Drainage|improving wound without evidence of fever, worsening cellulitis or induration|7 days|||participants|||Number
785770|NCT00829712|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 16 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
785771|NCT00829712|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 16 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
785772|NCT00829712|Primary|Cmax (Maximum Observed Concentration)|Bioequivalence based on Cmax.|Blood samples collected over a 16 hour period.|All participants that completed the study had their samples analyzed.||pg/mL||Standard Deviation|Mean
785773|NCT00829738|Secondary|Assessment of the Tolerability of Pantoprazole at Final Visit|Physician's assessment on a scale with 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory|14 days|Patients included and treated with at least one application of pantoprazole (without imputation of missing values), intention to treat||percentage of participants|||Number
785774|NCT00829738|Secondary|Assessment of Pantoprazole at Final Visit: Efficacy Regarding Irritable Bowel Syndrome|Physician's assessment on a scale with 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory|14 days|Patients included and treated with at least one application of pantoprazole (without imputation of missing values), intention to treat||percentage of participants|||Number
785775|NCT00829738|Secondary|Irritable Bowel Syndrome: Assessment of the Severity of Constipation|Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe|14 days|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat||units on a scale||Standard Deviation|Mean
785776|NCT00829738|Secondary|Irritable Bowel Syndrome: Assessment of the Severity of Diarrhoea|Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe|14 days|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat||units on a scale||Standard Deviation|Mean
785777|NCT00829738|Secondary|Irritable Bowel Syndrome: Assessment of the Severity of Lower Abdominal Pain|Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe|14 days|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat||units on a scale||Standard Deviation|Mean
785778|NCT00829738|Secondary|Assessment of Pantoprazole at Final Visit: Efficacy Regarding Dyspeptic Symptoms|Physician's assessment on a scale with 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory|14 days|Patients included and treated with at least one application of pantoprazole (without imputation of missing values), intention to treat||percentage of participants|||Number
785779|NCT00829738|Secondary|Functional Dyspepsia Symptoms: Assessment of the Severity of Nausea|Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe|14 days|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat||units on a scale||Standard Deviation|Mean
785780|NCT00829738|Secondary|Functional Dyspepsia Symptoms: Assessment of the Severity of Sensation of Fullness|Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe|14 days|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat||units on a scale||Standard Deviation|Mean
785781|NCT00829738|Secondary|Functional Dyspepsia Symptoms: Assessment of the Severity of Upper Abdominal Pain|Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe|14 days|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat||units on a scale||Standard Deviation|Mean
785782|NCT00829738|Primary|Assessment of Pantoprazole at Final Visit: Efficacy Regarding Reflux Symptoms|Physician's assessment on a scale with 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory|14 days|Patients included and treated with at least one application of pantoprazole (without imputation of missing values), intention to treat||percentage of participants|||Number
785783|NCT00829738|Primary|Reflux-associated Gastrointestinal Symptoms: Assessment of the Severity of Painful Swallowing|Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe|14 days|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat||units on a scale||Standard Deviation|Mean
785784|NCT00829738|Primary|Reflux-associated Gastrointestinal Symptoms: Assessment of the Severity of Eructation/Sour Eructation|Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe|14 days|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat||units on a scale||Standard Deviation|Mean
785785|NCT00829738|Primary|Reflux-associated Gastrointestinal Symptoms: Assessment of the Severity of Heartburn|Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe|14 days|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat||units on a scale||Standard Deviation|Mean
785786|NCT00829764|Primary|AUC0-inf = Area Under the Concentration-time Curve From Time Zero to Infinity.|Bioequivalence based on AUC0-inf.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
785787|NCT00829764|Primary|AUC0-t = Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration.|Bioequivalence based on AUC0-t.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
785788|NCT00829764|Primary|Cmax = Maximum Observed Concentration.|Bioequivalence based on Cmax.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
785789|NCT00829790|Primary|AUC0-inf = Area Under the Concentration-time Curve From Time Zero to Infinity.|Bioequivalence based on AUC0-inf.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
785790|NCT00829790|Primary|AUC0-t = Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration.|Bioequivalence based on AUC0-t.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
785791|NCT00829790|Primary|Cmax = Maximum Observed Concentration.|Bioequivalence based on Cmax.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
785792|NCT00829829|Secondary|Number of Gout Flare Days With Participant’s Pain Score of 5 or More (From Daily Diary) Per Participant From Day 1 to Day 112 (Week 16)|Participants were asked to complete a telephone diary by calling the IVRS daily beginning at the baseline visit (Day 1) through the follow-up visit (Day 141) and reported their general well-being, gout symptoms, and weekly study drug administrations. At the onset of pain from a gout flare, participants were to answer additional diary questions regarding their gout flare and had to continue daily flare assessments until they reported the flare had ended. If a flare occurred just prior to the follow-up visit (Day 141), participants were to continue completing the daily diary until the flare resolved. Gout flare pain was assessed on a scale from 0 to 10 (with 0=no pain and 10=severe pain) within the past 24 hours.|Day 1 to Day 112 (Week 16)|Full analysis set (FAS) that included all randomized participants who received any study medication and was based on the treatment allocated by IIVRS at randomization (as randomized).||Gout flare days||Standard Deviation|Mean
785793|NCT00829829|Secondary|Number of Gout Flare Days Per Participant From Day 1 to Day 112 (Week 16)|Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain, and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Number of gout flare days per participant was reported for this outcome measure.|Day 1 to Day 112 (Week 16)|Full analysis set (FAS) that included all randomized participants who received any study medication and was based on the treatment allocated by IIVRS at randomization (as randomized).||Gout flare Days||Standard Deviation|Mean
785794|NCT00829829|Secondary|Percentage of Participants With at Least Two Gout Flares From Day 1 to Day 112 (Week 16)|Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain, and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Percentage of participants with at least two gout flares was reported for this outcome measure.|Day 1 to Day 112 (Week 16)|Full analysis set (FAS) that included all randomized participants who received any study medication and was based on the treatment allocated by IIVRS at randomization (as randomized).||percentage of participants|||Number
785795|NCT00829829|Secondary|Percentage of Participants With at Least One Gout Flare From Day 1 to Day 112 (Week 16)|Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain; and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Percentage of participants with at least one gout flare was reported for this outcome measure.|Day 1 to Day 112 (Week 16)|Full analysis set (FAS) that included all randomized participants who received any study medication and was based on the treatment allocated by IIVRS at randomization (as randomized).||percentage of participants|||Number
785796|NCT00829829|Secondary|Number of Modified Gout Flares Per Participant From Day 1 to Day 112 (Week 16)|Modified gout flare was defined using modified definition of a gout flare as participant-reported articular pain typical of a gout attack that was deemed to require treatment with anti-inflammatory therapy. Number of modified gout flares per participant were reported for this outcome measure.|Day 1 to Day 112 (Week 16)|Full analysis set (FAS) that included all randomized participants who received any study medication and was based on the treatment allocated by IVRS at randomization (as randomized).||modified gout flares||Standard Deviation|Mean
785816|NCT00830024|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
785817|NCT00830024|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
785797|NCT00829829|Primary|Number of Gout Flares Per Participant Assessed From Day 1 to Day 112 (Week 16)|A gout flare was defined as participant reported acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Number of gout flares per participant was reported for this outcome measure. For drop-outs, only flares occurred before Day 112 were counted, regardless whether the flares occurred during the treatment period or not.|Day 1 to Day 112 (Week 16)|Full analysis set (FAS) that included all randomized participants who received any study medication and was based on the treatment allocated by IIVRS at randomization (as randomized).||Number of Gout flares per participant||Standard Deviation|Mean
785798|NCT00829868|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 12 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
785799|NCT00829868|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 12 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
785800|NCT00829868|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 12 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
785801|NCT00829933|Secondary|Pharmacodynamic Biomarkers (F1+2, TAT, and D-dimer )||12 weeks||||||
785802|NCT00829933|Secondary|Plasma DU-176 Concentration||12 weeks||||||
785803|NCT00829933|Secondary|Pharmacodynamic Parameters (PT, PT-INR, and APTT)|PT - prothrombin time INR - International Normalized Ratio APTT - Activated Partial Thromboplastin time|12 weeks||||||
785804|NCT00829933|Secondary|Incidence of Adverse Events and Adverse Reactions Identified During the Period From the Entry to the Treatment Period Until Completion or Termination of the Treatment||12 weeks||||||
785805|NCT00829933|Secondary|Incidence of Thromboembolic Events (Cerebral Infarction and Systemic Embolism) Identified During the Period From the Entry to the Treatment Period Until Completion or Termination of the Treatment.||12 weeks||||||
785806|NCT00829933|Primary|Incidence of Bleeding Events (Major Bleeding, Clinically Relevant Non-major Bleeding and Minor Bleeding ) Identified During the Period From the Entry Into the Treatment Period Until Completion or Termination of the Treatment.|The primary endpoint was the incidence of bleeding events (major bleeding, clinically relevant non-major bleeding, or minor bleeding) that occurred during the treatment period.|12 weeks|Primary endpoint analyzed for subjects who proceeded to treatment period in FAS.||percent of subjects with bleeding event||95% Confidence Interval|Number
785807|NCT00829985|Secondary|Percent of Participants With the Occurrence of Adverse Events (AE)|Percent of participants who experienced at least one adverse event|Participant enrollment to end of study (up to 6 months post-baseline)|Safety population||percentage of population|||Number
785808|NCT00829985|Secondary|Change in IgE Fragment Antibody Binding (FAB) Activity (60 Micrograms/mL Cockroach Allergen Extract)|Outcome is the change in mean IgE fragment antibody binding (FAB) activity, baseline to post-baseline. Serum from sensitized donor incubated with 60 micrograms/mL of cockroach allergen extract in presence or absence of equal volume of sera from study participants to assess allergen-IgE binding. (Presence of sera from those who previously received allergen-specific immunotherapy, viz., study participants post-baseline, expected to inhibit allergen-IgE complex binding.) This change is an indicator of immune modulation, however its clinical significance is unclear.|Baseline through 6-months of treatment|Intent-to-treat||Percent antibody binding||95% Confidence Interval|Mean
785809|NCT00829985|Secondary|Change in IgE Fragment Antibody Binding (FAB) Activity (30 Micrograms/mL Cockroach Allergen Extract)|Outcome is the change in mean IgE fragment antibody binding (FAB) activity, baseline to post-baseline. Serum from sensitized donor incubated with 30 micrograms/mL of cockroach allergen extract in presence or absence of equal volume of sera from study participants to assess allergen-IgE binding. (Presence of sera from those who previously received allergen-specific immunotherapy, viz., study participants post-baseline, expected to inhibit allergen-IgE complex binding.) This change is an indicator of immune modulation, however its clinical significance is unclear.|Baseline through 6-months of treatment|Intent-to-treat||Percent antibody binding||95% Confidence Interval|Mean
785810|NCT00829985|Secondary|Difference in German Cockroach-Specific Serum IgG4 Over Time|Outcome is the ratio of geometric means for baseline German cockroach-specific serum Immunoglobulin subclass 4 (IgG4) vs. post-baseline German cockroach-specific serum IgG4. This ratio is an indicator of immune modulation, however its clinical significance is unclear.|Baseline through 6-months of treatment|Intent-to-treat||Ratio||95% Confidence Interval|Geometric Mean
785811|NCT00829985|Primary|Difference in German Cockroach-Specific Serum IgE Over Time|Outcome is the ratio of geometric means for baseline German cockroach-specific serum Immunoglobulin E (IgE) vs. post-baseline German cockroach-specific serum IgE. This result is an indicator of immune modulation over time, however its clinical significance is unclear.|Baseline through 6-months of treatment|Intent-to-treat||Ratio||95% Confidence Interval|Geometric Mean
785812|NCT00829998|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 10 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
785813|NCT00829998|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 10 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
785814|NCT00829998|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 10 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
785815|NCT00830024|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
785818|NCT00830037|Secondary|Proteinuria|Proteinuria was estimated using measurements of urinary protein and creatinine before iron administration at baseline and at periodic intervals thereafter. Mean change from baseline log urinary protein/creatinine ratio (g/g) is reported at 2 years.|Baseline, 2 years|||g/g||95% Confidence Interval|Mean
785819|NCT00830037|Primary|Mean Rate of Decline in mGFR in the Two Groups - Oral and IV Iron|Plasma clearance of iothalamate was measured by administering an IV bolus of 5 mL of iothalamate meglumine and sampling 2 mL of blood at 0, 5, 10, 20, 30, 45, 60, 90, 120, 150, 180, 240, and 300 min after injection. Iothalamate was measured by high-performance liquid chromatography. Plasma clearance was calculated using a two-pool model using validated pharmacokinetic software. The mean modeled iothalamate mGFR slope (e.g., change from baseline to 2 years) in each group (IV iron vs. oral iron) was then calculated after adjustment for baseline log urinary protein/creatinine ratio.|Baseline, 2 years|Modeled iothalamate mGFR slope (e.g., change from baseline to 2 years) was calculated for each group (IV iron vs. oral iron) after adjustment for baseline log urinary protein/creatinine ratio.||Slope (ml/min per 1.73m2 per year)|||Number
785820|NCT00830076|Secondary|Incremental Post-prandial 4-hour Weighted Mean Plasma Glucose Concentrations|Meal was given 2 hours postdose. Blood samples for determination of glucose concentration were collected (4 hours postmeal) on Day 2 in each treatment period.|6 hours postdose (4 hours postmeal) on Day 2|||mg/dL||95% Confidence Interval|Least Squares Mean
785821|NCT00830076|Secondary|β-cell Sensitivity|"β-cell sensitivity was defined as the incremental post-prandial
4-hour area under the curve (AUC) for insulin secretion rate (ISR) normalized by the incremental post-prandial 4-hour plasma glucose AUC."|6 hour post-dose (4 hour postmeal) on Day 2|Beta-cell sensitivity was not calculated for 1 participant following the administration of sitagliptin alone and metformin alone due to missing insulin data.||(ng/min)/(mg/dL)*10^ -3||95% Confidence Interval|Least Squares Mean
785822|NCT00830076|Primary|Incremental Post-prandial 4-hour Weighted Mean Active Glucagon-like Peptide-1 (GLP-1) Plasma Concentrations|Meal was given 2 hours postdose. Blood samples for determination of active GLP-1 concentration were collected (4 hours postmeal) on Day 2 in each treatment period.|6 hours postdose (4 hours postmeal) on Day 2|||picomolar||95% Confidence Interval|Least Squares Mean
785823|NCT00830115|Secondary|Assessment of the Tolerability of Pantoprazole at Final Visit|Assessment on a scale: 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory|7 days|Patients included and treated with at least one application of pantoprazole (without imputation of missing values), intention to treat||Participants|||Number
785824|NCT00830115|Secondary|Assessment of the Efficacy of Pantoprazole at Final Visit|Assessment on a scale: 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory|7 days|Patients included and treated with at least one application of pantoprazole (without imputation of missing values), intention to treat||Participants|||Number
785825|NCT00830115|Secondary|Physician's Assessment of Painful Swallowing|Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe|7 days|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat||Units on a scale||Standard Deviation|Mean
785826|NCT00830115|Secondary|Physician's Assessment of Acid Eructation|Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe|7 days|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat||Units on a scale||Standard Deviation|Mean
785827|NCT00830115|Secondary|Physician's Assessment of Heartburn|Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe|7 days|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat||Units on a scale||Standard Deviation|Mean
785828|NCT00830115|Secondary|Patient's Assessment of Nausea for the Last 24 Hours (Diaries)|Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired|7 days|"All patients included and treated, intention to treat, missing values not imputed ('as observed').
Number of valid cases:
Day 0 = 809
Day 1 = 798
Day 2 = 776
Day 3 = 761
Day 4 = 743
Day 5 = 738
Day 6 = 732"||Units on a scale||Standard Deviation|Mean
785829|NCT00830115|Secondary|Patient's Assessment of Lower Abdominal/Digestive Complaints for the Last 24 Hours (Diaries)|Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired|7 days|"All patients included and treated, intention to treat, missing values not imputed ('as observed').
Number of valid cases:
Day 0 = 798
Day 1 = 782
Day 2 = 769
Day 3 = 759
Day 4 = 752
Day 5 = 739
Day 6 = 738"||Units on a scale||Standard Deviation|Mean
785830|NCT00830115|Secondary|Patient's Assessment of Upper-abdominal/Stomach Complaints for the Last 24 Hours (Diaries)|Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired|7 days|"All patients included and treated, intention to treat, missing values not imputed ('as observed').
Number of valid cases:
Day 0 = 887
Day 1 = 867
Day 2 = 846
Day 3 = 823
Day 4 = 801
Day 5 = 784
Day 6 = 773"||Units on a scale||Standard Deviation|Mean
785831|NCT00830115|Secondary|Patient's Assessment of Acid Complaints for the Last 24 Hours (Diaries)|Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired|7 days|"All patients included and treated, intention to treat, missing values not imputed ('as observed').
Number of valid cases:
Day 0 = 903
Day 1 = 891
Day 2 = 877
Day 3 = 843
Day 4 = 823
Day 5 = 791
Day 6 = 781"||Units on a scale||Standard Deviation|Mean
785832|NCT00830115|Secondary|Patient's Assessment of General Well-being for the Last 24 Hours (Diaries)|Assessment on a scale: Severity from 1=Excellent to 10=Extremely bad|7 days|"All patients included and treated, intention to treat, missing values not imputed ('as observed').
Number of valid cases:
Day 0 = 908
Day 1 = 906
Day 2 = 890
Day 3 = 876
Day 4 = 861
Day 5 = 842
Day 6 = 834"||Units on a scale||Standard Deviation|Mean
785833|NCT00830115|Primary|Physician's Assessment of Sleep Disturbances|Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe|7 days|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat||Units on a scale||Standard Deviation|Mean
785834|NCT00830115|Primary|Patient's Assessment of Sleep Disturbances for the Last 24 Hours (Diaries)|Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired|7 days|"All patients included and treated, intention to treat, missing values not imputed ('as observed').
Number of valid cases:
Day 0 = 846
Day 1 = 841
Day 2 = 828
Day 3 = 817
Day 4 = 800
Day 5 = 791
Day 6 = 790"||Units on a scale||Standard Deviation|Mean
785882|NCT00830206|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 168 hour period|One subject was excluded from statistical analysis due to emesis during sample collection period.||ng*h/mL||Standard Deviation|Mean
785835|NCT00830115|Primary|Patient's Assessment of Stanford Sleepiness Scale for the Last 24 Hours (Diaries)|Assessment on a scale from 1=Feeling active, vital, alert, or wide awake to 7=No longer fighting sleep, sleep onset soon, having dream-like thoughts|7 days|"All patients included and treated, intention to treat, missing values not imputed ('as observed').
Number of valid cases:
Day 0 = 869
Day 1 = 868
Day 2 = 867
Day 3 = 864
Day 4 = 863
Day 5 = 859
Day 6 = 862"||Units on a scale||Standard Deviation|Mean
785836|NCT00830128|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) - Subscale Score at Endpoint|"FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment.
Change = mean FIQ scores at observation minus mean scores at baseline."|Baseline, Week 52 or Study Discontinuation|All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
785837|NCT00830128|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) - Total Scores at Endpoint|"FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment.
Change = mean FIQ scores at observation minus mean scores at baseline."|Baseline, Week 52 or Study Discontinuation|All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
785838|NCT00830128|Secondary|Medical Outcomes Study (MOS) Sleep Scale - Optimal Sleep at Endpoint|MOS-Sleep is a patient-rated questionnaire to assess sleep quality and quantity. Optimal sleep component is derived from Sleep Quantity average hours of sleep each night during the past 4 weeks. Number of participants with response = YES if sleep quantity is 7 or 8 hours per night or response = NO if sleep quantity is < 7 hours per night.|Week 52 or Study Discontinuation|All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment.||Paticipants|||Number
785839|NCT00830128|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Overall Sleep Problems Index at Endpoint|"MOS: patient rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Overall Sleep Problems Index rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score means worse symptoms.
Change = mean scores at observation minus mean scores at baseline."|Baseline, Week 52 or Study Discontinuation|All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
785840|NCT00830128|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Somnolence at Endpoint|"MOS: patient rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Somnolence subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score means worse symptoms.
Change = mean scores at observation minus mean scores at baseline."|Baseline, Week 52 or Study Discontinuation|All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
785841|NCT00830128|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Quantity of Sleep at Endpoint|"MOS: patient rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Quantity of Sleep subscales rated 0 to 24 (number of hours slept). A higher score means greater quantity of sleep.
Change = mean scores at observation minus mean scores at baseline."|Baseline, Week 52 or Study Discontinuation|All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment.||hours||Standard Deviation|Mean
785842|NCT00830128|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Sleep Adequacy at Endpoint|"MOS: patient rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Sleep Adequacy subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score means greater sleep adequacy.
Change = mean scores at observation minus mean scores at baseline."|Baseline, Week 52 or Study Discontinuation|All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
785843|NCT00830128|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Awaken Short of Breath or With a Headache at Endpoint|"MOS: patient rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Awaken Short of Breath or With a Headache subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score means worse symptoms.
Change = mean scores at observation minus mean scores at baseline."|Baseline, Week 52 or Study Discontinuation|All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
785883|NCT00830206|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 168 hour period|One subject was excluded from statistical analysis due to emesis during sample collection period.||ng/mL||Standard Deviation|Mean
785884|NCT00830219|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
785844|NCT00830128|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Snoring at Endpoint|"MOS: patient rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Snoring subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score means worse symptoms.
Change = mean scores at observation minus mean scores at baseline."|Baseline, Week 52 or Study Discontinuation|All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
785845|NCT00830128|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Sleep Disturbance at Endpoint|"MOS: patient rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Sleep Disturbance subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score means greater sleep disturbance.
Change = mean scores at observation minus mean scores at baseline."|Baseline, Week 52 or Study Discontinuation|All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
785846|NCT00830128|Secondary|Change From Baseline in Pain Visual Analog Scale (Pain VAS) Score at Endpoint|"The pain VAS is a horizontal line; 100 mm in length, self-administered by the patient to rate pain from 0 (no pain) to 100 (worst possible pain). The score indicates the pain intensity during the past 1 week before a visit.
Change = mean scores at observation minus mean scores at baseline."|Baseline, Week 52 or Study Discontinuation|All participants who have taken at least 1 dose of the study medication, regardless of compliance with the study medication, and have at least 1 postbaseline efficacy assessment.||mm||Standard Deviation|Mean
785847|NCT00830128|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|Any untoward medical occurrence in a participant who received study drug was considered an adverse event (AE), without regard to possibility of causal relationship. Treatment-emergent adverse events: those which occurred or worsened after baseline. An AE resulting in any of the following outcomes, was considered to be a serious adverse event: death; lifethreatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect.|Up to 53 weeks|All participants who received at least 1 dose of the study medication.||Participants|||Number
785848|NCT00830167|Secondary|Change From Baseline in Pain Visual Analog Scale (Pain VAS) Score at Endpoint|The pain VAS is a horizontal line; 100 mm in length, self-administered by the patient to rate pain from 0 (no pain) to 100 (worst possible pain). The score indicates the pain intensity during the past 1 week before a visit. Change = mean scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.||Scores on a scale||Standard Error|Least Squares Mean
785849|NCT00830167|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Depression|Change: Mean HADS score at observation minus Mean at baseline. HADS anxiety and depression subscale scores range from 0 to 21, with higher scores indicating greater severity of the subscale condition.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.||Scores on a scale||Standard Error|Least Squares Mean
785850|NCT00830167|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety|Change: Mean HADS score at observation minus Mean at baseline. HADS anxiety and depression subscale scores range from 0 to 21, with higher scores indicating greater severity of the subscale condition.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.||Scores on a scale||Standard Error|Least Squares Mean
785851|NCT00830167|Secondary|Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Mental Health|Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.||Scores on a scale||Standard Error|Least Squares Mean
785852|NCT00830167|Secondary|Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Vitality|Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.||Scores on a scale||Standard Error|Least Squares Mean
785862|NCT00830167|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Morning|FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.||Scores on a scale||Standard Error|Least Squares Mean
785853|NCT00830167|Secondary|Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Role Limitations-Emotional|Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.||Scores on a scale||Standard Error|Least Squares Mean
785854|NCT00830167|Secondary|Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Social Functioning|Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.||Scores on a scale||Standard Error|Least Squares Mean
785855|NCT00830167|Secondary|Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- General Health Perception|Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.||Scores on a scale||Standard Error|Least Squares Mean
785856|NCT00830167|Secondary|Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Bodily Pain|Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.||Scores on a scale||Standard Error|Least Squares Mean
785857|NCT00830167|Secondary|Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Role Limitations-Physical|Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.||Scores on a scale||Standard Error|Least Squares Mean
785858|NCT00830167|Secondary|Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Physical Functioning|Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.||Scores on a scale||Standard Error|Least Squares Mean
785859|NCT00830167|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Depression|FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.||Scores on a scale||Standard Error|Least Squares Mean
785860|NCT00830167|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Anxious|FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.||Scores on a scale||Standard Error|Least Squares Mean
785861|NCT00830167|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Stiffness|FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.||Scores on a scale||Standard Error|Least Squares Mean
785881|NCT00830206|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 168 hour period|One subject was excluded from statistical analysis due to emesis during sample collection period.||ng*h/mL||Standard Deviation|Mean
785863|NCT00830167|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Tiredness|FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.||Scores on a scale||Standard Error|Least Squares Mean
785864|NCT00830167|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Pain|FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.||Scores on a scale||Standard Error|Least Squares Mean
785865|NCT00830167|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Housework|FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.||Scores on a scale||Standard Error|Least Squares Mean
785866|NCT00830167|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Work Miss|FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.||Scores on a scale||Standard Error|Least Squares Mean
785867|NCT00830167|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Feel Good|FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.||Scores on a scale||Standard Error|Least Squares Mean
785868|NCT00830167|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Physical Function|FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.||Scores on a scale||Standard Error|Least Squares Mean
785869|NCT00830167|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Total Scores|FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.||Scores on a scale||Standard Error|Least Squares Mean
785870|NCT00830167|Secondary|Change From Baseline in Sleep Quality Score at Endpoint|Change: Mean sleep quality score at endpoint minus mean at baseline. Sleep quality scores range from 0-10 with higher scores indicating decreased sleep quality.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.||Scores on a scale||Standard Error|Least Squares Mean
785871|NCT00830167|Secondary|Medical Outcomes Study (MOS) Sleep Scale - Number of Participants With Optimal Sleep at Endpoint|MOS-Sleep is a patient-rated questionnaire to assess sleep quality and quantity. Optimal sleep component is derived from Sleep Quantity average hours of sleep each night during the past 4 weeks. Optimal sleep was defined as sleep quantity of 7 or 8 hours per night.|Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.||Participants|||Number
785872|NCT00830167|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Overall Sleep Problems Index|MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Overall Sleep Problems Index subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of overall sleep problems. Change = mean scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.||Scores on a scale||Standard Error|Least Squares Mean
785873|NCT00830167|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Somnolence|MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Somnolence subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of somnolence. Change = mean scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.||Scores on a scale||Standard Error|Least Squares Mean
785874|NCT00830167|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Sleep Adequacy|MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Sleep Adequacy subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of sleep adequacy. Change = mean scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.||Scores on a scale||Standard Error|Least Squares Mean
785875|NCT00830167|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Quantity of Sleep|MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Quantity of Sleep subscales rated 0 to 24 (number of hours slept). A higher score indicates greater quantity of sleep. Change = mean scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.||Scores on a scale||Standard Error|Least Squares Mean
785876|NCT00830167|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Awaken Short of Breath or With a Headache|MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Awaken Short of Breath or With a Headache subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of the symptom. Change = mean scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.||Scores on a scale||Standard Error|Least Squares Mean
785877|NCT00830167|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Snoring|MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Snoring subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of snoring. Change = mean scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.||Scores on a scale||Standard Error|Least Squares Mean
785878|NCT00830167|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Sleep Disturbance|MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Sleep Disturbance subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of sleep disturbance. Change = mean scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.||Scores on a scale||Standard Error|Least Squares Mean
785879|NCT00830167|Secondary|Percentage of Participants Who Was Categorized as “Improved (Very Much Improved, Much Improved, or a Minimally Improved)” According to the Patient Global Impressions of Change (PGIC)|PGIC was defined as participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Change was defined as a score of 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse) , 6 (much worse) or 7 (very much worse) on the scale.|Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication.||Percentage of participants|||Number
785880|NCT00830167|Primary|Change From Baseline for Numerical Rating Scale (NRS) Pain Scores at Endpoint-LOCF (Last Observation Carried Forward) Relative to Baseline|Change from baseline in mean NRS-Pain scores at endpoint-LOCF. Daily pain scores were assessed on an 11-point numerical rating scale <(NRS)-Pain> ranging from 0 (no pain) to 10 (worst possible pain).|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.||Scores on a scale||Standard Error|Least Squares Mean
785885|NCT00830219|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
785886|NCT00830219|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Cmax.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed.||pg/mL||Standard Deviation|Mean
785887|NCT00830232|Secondary|Subclinical Cerebral Embolization Assessed by Brain Diffusion-weighted MRI||within 24 hours after carotid artery stenting||||||
785888|NCT00830232|Secondary|Composite of Any Stroke, Myocardial Infarction or Death||within 30 days after the carotid stenting procedure||||||
785889|NCT00830232|Primary|Transcranial Doppler Counts of Micro-embolic Signals in the Ipsilateral Middle Cerebral Artery.|Bilateral transcranial Doppler scan monitoring of the anterior and middle cerebral arteries was performed using a PMD150-ST3 digital transcranial Doppler pulsed-wave ultrasound scan system (Spencer Technologies, Seattle, Wash) with 2-MHz probes located over the temporal bones above the zygomatic arch. Isolated microembolic signals (MES) were identified from Doppler spectras according to the criteria given by the Consensus Committee of the Ninth International Cerebral Hemodynamic Symposium. If the number of MES was too high to be counted separately, heartbeats with microemboli were counted as microembolic showers. To avoid confusion, MES detected during contrast injection were excluded from the analysis. For analysis purposes, the procedure was divided into the following phases: lesion crossing, filter deployment, IVUS examination, predilation, stent deployment, postdilatation (when applicable), and filter removal.|First 24 hours after implantation of carotid stent|||Micro-emboli||Inter-Quartile Range|Median
785890|NCT00830258|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 16 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
785891|NCT00830258|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 16 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
785892|NCT00830258|Primary|Cmax - Maximum Observed Concentration - Pravastatin in Plasma|Bioequivalence based on Cmax|Blood samples collected over 16 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
785893|NCT00830284|Secondary|Safety - Airleak, Cardiac Compromise, Respiratory Acidosis.||4 hours|||Participants|||Count of Participants
785894|NCT00830284|Primary|PaO2 + PaCO2 of 400 or Higher.||2 hours|||Participants|||Count of Participants
785895|NCT00830310|Primary|Change in Treatment Adherence as Measured by the Morisky Scale|The minimum score is 0 and the maximum score is 4. A higher score implies poorer treatment adherence.|From Baseline to 3 months|Number of participants for analysis was based on all available data at the three month time point.||units on a scale||Standard Error|Mean
785896|NCT00830310|Primary|Change in Treatment Non-adherence as Measured by the Tablets Routine Questionnaire (TRQ) (Past Week)|"Treatment nonadherence is measured as a percentage of medications not taken within the past week at time of assessment.
The minimum score is 0 and the maximum score is 100. A higher score implies poorer treatment adherence."|From Baseline to 3 months|Number of participants for analysis was based on all available data at the three month time point.||percentage of medications not taken||Standard Error|Mean
785897|NCT00830310|Secondary|Change in Symptoms of Bipolar Disorder as Measured by the Brief Psychiatric Rating Scale (BPRS)|The minimum score is 18 and the maximum score is 126. A higher score implies a worse condition.|From Baseline to 3 months|Number of participants for analysis was based on all available data at the three month time point.||units on a scale||Standard Error|Mean
785898|NCT00830310|Secondary|Change in Symptoms of Bipolar Disorder as Measured by the Hamilton Depression Rating Scale (HAM-D)|The minimum score is 0 and the maximum score is 52. A higher score implies a worse condition.|From Baseline to 3 months|Number of participants for analysis was based on all available data at the three month time point.||units on a scale||Standard Error|Mean
785899|NCT00830310|Secondary|Change in Functional Status as Measure by the Global Assessment of Functioning Scale (GAF)|The minimum score is 1 and the maximum score is 100. A higher score implies higher functioning.|From Baseline to 3 months|Number of participants for analysis was based on all available data at the three month time point.||units on a scale||Standard Error|Mean
785900|NCT00830310|Secondary|Change in Overall Treatment Attitudes as Measured by the Drug Attitude Inventory (DAI)|The minimum score is 0 and the maximum score is 10. A higher score implies a better attitude.|From Baseline to 3 months|Number of participants for analysis was based on all available data at the three month time point.||units on a scale||Standard Error|Mean
785901|NCT00830310|Secondary|Change in Global Psychopathology as Measured by the Clinical Global Impression Scale (CGI)|The minimum possible score is 1 and the maximum score is 7. A higher score implies a worse condition.|From Baseline to 3 months|Number of participants for analysis was based on all available data at the three month time point.||units on a scale||Standard Error|Mean
785902|NCT00830310|Secondary|Change in Symptoms of Bipolar Disorder as Measured by the Young Mania Rating Scale (YMRS)|The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition.|From Baseline to 3 months|Number of participants for analysis was based on all available data at the three month time point.||units on a scale||Standard Error|Mean
785903|NCT00830310|Primary|Change in Treatment Non-adherence as Measured by the Tablets Routine Questionnaire (TRQ) (Past Month)|"Treatment non-adherence is measured as a percentage of medications not taken within the past month at time of assessment.
The minimum score is 0 and the maximum score is 100. A higher score implies poorer treatment adherence."|From Baseline to 3 months|Number of participants for analysis was based on all available data at the three month time point.||percentage of medication not taken||Standard Error|Mean
785904|NCT00830336|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 168 hour period|Samples for two subjects who completed the study were not analyzed per protocol due to emesis during the sample collection period.||ng*h/mL||Standard Deviation|Mean
785905|NCT00830336|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 168 hour period|Samples for two subjects who completed the study were not analyzed per protocol due to emesis during the sample collection period.||ng*h/mL||Standard Deviation|Mean
785906|NCT00830336|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 168 hour period|Samples for two subjects who completed the study were not analyzed per protocol due to emesis during the sample collection period.||ng/mL||Standard Deviation|Mean
785907|NCT00830362|Primary|Single Item Craving Test Session Difference Scores|Mean of the difference of Session 1 and Session 2 cocaine craving scores (Session 2-Session 1). Found by using our Single Item Craving (SIC) scale. A study team member asks the participant to verbally report the level of craving they were experiencing using values between 0 and 100, with 0 representing no craving and 100 extreme craving. The difference score was found by subtracting session 1 mean SICs during cue exposure from session 2 mean SICs during cue exposure. Therefore the mean of the difference could have ranged anywhere from -100 to 100. Negative mean difference scores reflect a decrease in craving for cocaine from session 1 (test) to session 2 (retrieval). The lower the mean difference score, the greater the decrease in craving.|Both days of cue exposure|||units on a scale||Standard Error|Mean
785908|NCT00830375|Primary|Yale Brown Obsessive Compulsive Scale Modified for CB (CB-YBOCS)|The CB-YBOCS is a reliable and valid, 10-item, clinician-administered scale that rates buying symptoms within the last seven days, on a severity scale from 0 to 4 for each item (total scores range from 0 to 40 with higher scores reflecting greater illness severity). Scores ranging from 0 to 10 reflect minimal or mild symptoms; scores from 11 to 20 suggest moderate symptoms; severe symptoms are associated with scores from 21 to 30; and scores greater than 30 reflect extreme buying symptoms|from study start to study end (8-weeks) and is Investigator rated|Reported scores are Mean and standard deviation for Subjects last visit (Week 8 or last-observation carried forward).||units on a scale||Standard Deviation|Mean
785909|NCT00830388|Secondary|To Assess the Safety of Ketoconazole 2% Foam for the Treatment of Tinea Versicolor Based on the Occurrence of Adverse Events.|Adverse events were used to assess safety.|4 weeks|||events|||Number
785910|NCT00830388|Primary|The Effect of Ketoconazole 2% Foam for the Treatment of Tinea Versicolor|Eleven participants were tested for the microscopic presence of yeast. At four weeks, all participants were re-tested and deemed positive if yeast continued to be present microscopically.|4 weeks|||participants|||Number
785911|NCT00830440|Secondary|Count of Subjects With Decrease in HbA1c Values From Baseline to Week 12||Baseline to Week 12 of treatment|Type 2 Diabetes Subjects||Participants|||Count of Participants
785912|NCT00830440|Secondary|% of Subjects Achieving at Least a 10% Change in Excess Weight From Baseline to 12 Weeks|The percent excess weight loss calculated using the Metropolitan Life Tables (MET). The actual amount of excess weight loss (EWL) was examined through the percent of actual weight change from baseline.|12 weeks|||% participants|||Number
785913|NCT00830440|Primary|Total Weight Change From Baseline at 12 Weeks in kg||12 weeks|26 subjects received the device. 2 subjects had the device removed before 12 weeks.||kg||Standard Deviation|Mean
785914|NCT00830596|Primary|Response to Sudden Load Response Times|Changes in sensorimotor function, as measured by response to sudden load in patients with LBP from baseline to 2 weeks. The adjusted within-group mean changes from baseline to two week follow-up are detailed below for for Response to sudden load [RTSL] (ant. COP=anterior movement in center of pressure, L=left side of erector spinae, R=right side of erector spinae)|Baseline and 2 weeks|||ms||95% Confidence Interval|Mean
785915|NCT00830596|Primary|Response to Sudden Load, Peak Muscle Response Per Side|Changes in sensorimotor function, as measured by response to sudden load in patients with LBP from baseline to 2 weeks. The adjusted within-group mean changes from baseline to two week follow-up are detailed below for for Response to sudden load [RTSL] (ant. COP=anterior movement in center of pressure, L=left side of erector spinae, R=right side of erector spinae)|Baseline and 2 weeks|||% muscle response||95% Confidence Interval|Mean
785916|NCT00830596|Primary|Response to Sudden Load, Anterior Movement in Center of Pressure Excursion in SL|Changes in sensorimotor function, as measured by response to sudden load in patients with LBP from baseline to 2 weeks. The adjusted within-group mean changes from baseline to two week follow-up are detailed below for Response to sudden load [RTSL], ant. COP=anterior movement in center of pressure|Baseline and 2 weeks|||mm||95% Confidence Interval|Mean
785917|NCT00830596|Primary|Postural Sway Speed|"Changes in sensorimotor function, as measured by postural sway speed in patients with LBP from baseline to 2 weeks. The adjusted within-group mean changes from baseline to two week follow-up are detailed below for:
Sway Speed=overall center of pressure traveling distance divided by time."|Baseline and 2 weeks|||mm/s||95% Confidence Interval|Mean
785918|NCT00830596|Primary|Postural Sway|"Changes in sensorimotor function, as measured by postural sway in patients with LBP from baseline to 2 weeks. The adjusted within-group mean changes from baseline to two week follow-up are detailed below for:
Postural sway (AP=mean excursion in the anterior-posterior direction, ML= mean excursion in the medial-to-lateral direction."|Baseline and 2 weeks|||mm||95% Confidence Interval|Mean
785919|NCT00830765|Primary|Weeks Gestation at Birth Among Patients Receiving the Active Drug.|Weeks gestation at birth, the interval to delivery, or neonatal morbitity.|Through delivery, until discharge up to 40 weeks gestation|Intention to treat analysis in both groups||weeks||Standard Deviation|Mean
785920|NCT00831233|Secondary|Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables|The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) levels of safety laboratory variables. Only the laboratory variables that had at least on participant with one abnormal value are presented, many more variables were included in the trial.|Baseline to 12 weeks of treatment|FAS.||participants|||Number
785921|NCT00831233|Secondary|Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight|This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value.|Baseline to 12 weeks of treatment|FAS. One participant in the degarelix group did not have any assessment of vital signs or body weight (the number of participants in this group is thus 26).||participants|||Number
785922|NCT00831233|Secondary|Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit|The IPSS questionnaire included an additional single question to assess the participant’s QoL in relation to his urinary symptoms. The question was: ‘If you were to spend the rest of your life with your urinary condition the way it is now, how would you feel about that?’ The possible answers to this question ranged from ‘delighted’ (a score of ‘0’) to ‘terrible’ (a score of ‘6’). The figures in the tables present the change (ie decrease) in IPSS QoL score, i.e. the bigger the decrease the better QoL.|After treatment of 4, 8 and 12 weeks compared to Baseline|FAS, OC.||score on scale||Standard Deviation|Mean
785923|NCT00831233|Secondary|Percentage Change From Baseline in Prostate-specific Antigen (PSA) Concentration at Each Visit||After treatment of 4, 8 and 12 weeks compared to Baseline|FAS, LOCF.||percentage||Full Range|Median
785924|NCT00831233|Secondary|Number of Participants With Testosterone <=0.5 Nanograms/Milliliter at Each Visit||After treatment of 4, 8 and 12 weeks compared to Baseline|FAS, OC.||participants|||Number
785925|NCT00831233|Secondary|Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12|TRUS is a method of measuring the size of the prostate.|After 12 weeks treatment compared to Baseline|FAS, Observed Cases (OC).||mL||Standard Deviation|Mean
785926|NCT00831233|Secondary|Change From Baseline in Residual Volume (Vresidual) at Each Visit|Uroflowmetry was used to quantify the residual volume (Vresidual; mL)|After treatment of 4, 8 and 12 weeks compared to Baseline|FAS, LOCF.||mL||Standard Deviation|Mean
785927|NCT00831233|Secondary|Change From Baseline in Maximum Urine Flow (Qmax) at Each Visit|Uroflowmetry was used to quantify the maximum urine flow (Qmax; mL/sec)|After treatment of 4, 8 and 12 weeks compared to Baseline|FAS, LOCF.||mL/sec||Standard Deviation|Mean
785928|NCT00831233|Secondary|Change From Baseline in Total IPSS at Weeks 4 and 8|The IPSS is a tool commonly used to assess the severity of lower urinary tract symptoms (LUTS), and to monitor the progress of the disease once treatment has been initiated. The participant completes a questionnaire containing 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5. The total score is then classified according to the following scale: 0 to 7 = mildly symptomatic; 8 to 19 = moderately symptomatic; and 20 to 35 = severely symptomatic.|After treatment of 4 and 8 weeks compared to Baseline|FAS, LOCF.||score on scale||Standard Deviation|Mean
785929|NCT00831233|Primary|Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12|The IPSS is a tool commonly used to assess the severity of lower urinary tract symptoms (LUTS), and to monitor the progress of the disease once treatment has been initiated. The participant completes a questionnaire containing 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5. The total score is then classified according to the following scale: 0 to 7 = mildly symptomatic; 8 to 19 = moderately symptomatic; and 20 to 35 = severely symptomatic.|After treatment of 12 weeks compared to Baseline|Full Analysis Set (FAS) + Per Protocol (PP) Analysis Set, Last Observation Carried Forward (LOCF).||score on scale||Standard Deviation|Mean
785930|NCT00831272|Primary|Clinical Response to Naltrexone, as Measured by a Reduction in the Percent Days of Heavy Drinking Days (as Defined by >5 Drinks/Day for Males; >4 for Females) During the 12 Weeks of the Trial.||12 weeks|Repeated weekly measures of drinking outcomes were compared using generalized estimating equation models (GEE). The explanatory variables of primary interest comprised binary indicators for intervention group, genotype, and their interaction, a linear trend for time, and terms for interactions involving time and the group and genotype factors.||percentage of heavy drinking days||Standard Deviation|Mean
785931|NCT00831311|Secondary|Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®|"Solicited systemic reactions: Pyrexia (temperature), Somnolence, Irritability, Anorexia, Vomiting not otherwise specified (NOS), Diarrhea NOS, and Crying were assessed in each participant following vaccination.
Grade 3 reactions defined as: Pyrexia (temperature), ≥ 39.1°C; Somnolence, sleeping most of the time; Irritability, continuously irritable for ≥ 3 hours; Anorexia, refused most or all feeds; Vomiting NOS, frequent vomiting and inability to have any oral intake; Diarrhea NOS, multiple liquid stools without any solid material; and Crying, persistent, inconsolable cry ≥ 3 hours and/or high-pitched cry."|Day 0 up to Day 7 post-vaccination|Safety was assessed on the safety analysis (intent-to- treat) population.||Participants|||Number
785932|NCT00831311|Secondary|Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B®|Solicited injection site reactions - erythema, edema, induration, and pain were assessed in each participant at the DTaP-IPV-Hep B-PRP~T and ENGERIX B® injection sites.|Day 0 up to Day 7 post-vaccination|Safety was assessed on the safety analysis (intend-to-treat) population.||Participants|||Number
785933|NCT00831311|Secondary|Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™|Solicited injection site reactions - erythema, edema, induration, and pain were assessed in each participant at the DTaP-IPV-Hep B-PRP~T and PENTAXIM™ injection sites|Day 0 up to Day 7 post-vaccination|Safety was assessed on the safety analysis (intent-to- treat) population.||Participants|||Number
785934|NCT00831311|Primary|Geometric Mean Titers of Anti-Polio Types 1, 2, and 3 Antibodies Before and Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®|Geometric mean titers to the Polio Antigens were assessed by means of microneutralization assay for anti-polio types 1, 2, and 3 before the first vaccination (at Day 0) and 1 month post-vaccination 3 (Day 150).|Day 150 (1 month post-vaccination 3)|Geometric mean titers to the Polio Antigens were assessed in the per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
785935|NCT00831311|Primary|Geometric Mean Titers of Anti-Tetanus Before and Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®|Geometric mean titers to Tetanus antigen was assessed by means of enzyme immunoassay (EIA) before the first vaccination (at Day 0) and 1 month after the third vaccination (Day 150).|Day 150 (1 month post-vaccination 3)|Geometric mean titers to the vaccine antigens were assessed in the per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
786194|NCT00833690|Secondary|Serum Urate|From blood sample drawn prior to enrollment|Screening Visits, up to 45 days prior to Baseline Visit. Specifically, Screening Visit 1 occurred between day -45 and -4; Screening Visit 2 occurred between day -43 and -2.|||mg/dL||Standard Deviation|Mean
785936|NCT00831311|Primary|Percentage of Participants With Seroprotection for Anti-Hepatitis B, Anti-Polyribosyl Ribitol Phosphate (PRP), Anti-Tetanus, Anti-Diphtheria, and Anti-Polio Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®|"Immunogenicity was assessed by radioimmunoassay (RIA) for anti-hepatitis B (HBs) and anti-PRP antibodies, enzyme immunoassay (EIA) for anti-tetanus, serum neutralization (SN) for anti-diphtheria, and microneutralization for anti-polio type 1, 2, and 3 antibodies.
Seroprotection was defined as titers ≥ 10 mIU/mL for anti-Hepatitis Bs, ≥ 0.15 μg/mL for anti-PRP, ≥ 0.01 IU/mL for anti-tetanus and anti-diphtheria, and ≥ 8 1/dil for anti-polio types 1, 2, and 3 at 30 days after the third vaccination."|Day 150 (1 month post-vaccination 3)|Seroprotection to the vaccine antigens was assessed in the per-protocol population.||Percentage of Participants|||Number
785937|NCT00831311|Primary|Percentage of Participants With Seroconversion for Anti-pertussis Toxoid and Anti-filamentous Hemagglutinin Antibodies Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®|Seroconversion was assessed by means of enzyme immunoassay (EIA) for anti-pertussis toxoid (PT) and anti-filamentous hemagglutinin (FHA) antibodies. Seroconversion was defined as ≥ 4 fold increase in antibody titers from Day 0 to 30 days after the third vaccination.|1 month post last vaccination|Seroconversion for anti-pertussis toxoid and anti-filamentous hemagglutinin antibodies was assessed in the per-protocol population.||Percentage of Participants|||Number
785938|NCT00831389|Post-Hoc|Overall Incidence of Hypoglycemia|Tally of episodes where either plasma glucose (PG) < 60 mg/dL, or supplemental glucose was administered to prevent imminent PG < 60 mg/dL. Maximum tally of hypoglycemic events within any 30 minute period is 1.|Begins at 6:00 of in-patient visit day 2 and ends at 6:00 of day 4; 48 hours total.|All subjects were used for final analysis||hypoglycemic events||Inter-Quartile Range|Median
785939|NCT00831389|Secondary|Percentage of Time Plasma Glucose (PG) is Below the Euglycemic Range.|For each subject and study phase, the percentage of the PG curve < 70 mg/dL. Linear interpolations furnished the data between the actual sampled PG to address potential sample influence bias arising from non-uniform sampling intervals.|Begins at 6:00 of in-patient visit day 2 and ends at 6:00 of day 4; 48 hours total.|All subjects were used for final analysis||percentage of time||Inter-Quartile Range|Median
785940|NCT00831389|Secondary|Percentage of Time Plasma Glucose (PG) is Above the Euglycemic Range.|For each subject and study phase, the percentage of the PG curve > 180 mg/dL. Linear interpolations furnished the data between the actual sampled PG to address potential sample influence bias arising from non-uniform sampling intervals.|Begins at 6:00 of in-patient visit day 2 and ends at 6:00 of day 4; 48 hours total.|All subjects were used for final analysis||percentage of time||Inter-Quartile Range|Median
785941|NCT00831389|Secondary|Percentage of Time Plasma Glucose (PG) is Within the Euglycemic Range.|For each subject and arm, the percentage of the PG curve such that 70 <= PG curve <= 180 mg/dL. Linear interpolations furnished the data between the actual sampled PG to address potential sample influence bias arising from non-uniform sampling intervals.|Begins at 6:00 of in-patient visit day 2 and ends at 6:00 of day 4; 48 hours total.|All subjects were used for final analysis||percentage of time||Inter-Quartile Range|Median
785942|NCT00831389|Secondary|Overnight Nadir Plasma Glucose (PG)|For each subject and study phase, the overnight nadir PG for each of two nights were determined. The mean of these two nadirs became the one nadir overnight PG value representing each subject and study phase.|Union of the two 8-hour overnight periods beginning at 22:00 on in-patient visit days 2 & 3, ending at 6:00 on the subsequent day. The union of the two periods was 960 minutes (min) for all subjects, both study phases.|All subjects were used for final analysis||mg/dL||Inter-Quartile Range|Median
785943|NCT00831389|Secondary|Nadir Plasma Glucose (PG) Immediately Following Exercise|The PG nadir observed following the start of exercise|Begins at start of exercise, at or after 15:00 on the in-patient visit day randomly assigned each subject for exercise; ends at start of the subsequent meal. Median period: 121 minutes (min), interquartile range (IQR): 15 min, range: 93 to 133 min.|All subjects were used for final analysis||mg/dL||Inter-Quartile Range|Median
785944|NCT00831389|Secondary|Peak Post-prandial Plasma Glucose (PG)|For each subject and study phase, the six peak PG following each of the six meals were determined. The median of these six peaks became the one peak post-prandial PG value representing each subject and study phase.|Union of 6 meal periods (3 per day on study days 2 & 3). A meal period runs from meal start to start of next meal, or 22:00 for 3rd meal of the day. Union of 6 periods median: 1666 minutes (min), interquartile range (IQR): 15 min, range: 1638 to 1680 min.|All subjects were used for final analysis||mg/dL||Inter-Quartile Range|Median
785945|NCT00831389|Primary|Incidence of Nocturnal Hypoglycemia Following Exercise|Tally of episodes where either plasma glucose (PG) < 60 mg/dL, or supplemental glucose was administered to prevent imminent PG < 60 mg/dL. Maximum tally of hypoglycemic events within any 30 minute period is 1.|Begins at 22:00 on the in-patient visit day randomly assigned each subject for exercise; ends at 6:00 of the subsequent day. Period was 480 minutes (min) for all subjects, both study phases.|All subjects were used for final analysis||hypoglycemic events||Inter-Quartile Range|Median
785946|NCT00831389|Primary|Incidence of Hypoglycemia Immediately Following Exercise|Tally of episodes where either plasma glucose (PG) < 60 mg/dL, or supplemental glucose was administered to prevent imminent PG < 60 mg/dL. Maximum tally of hypoglycemic events within any 30 minute period is 1.|Begins at end of exercise, at or after 16:15 on the in-patient visit day randomly assigned each subject for exercise; ends at 22:00 of same day. Median period: 333 minutes (min), interquartile range (IQR): 28 min, range: 262 to 344 min.|All subjects were used for final analysis||hypoglycemic events||Inter-Quartile Range|Median
785947|NCT00831389|Primary|Plasma Glucose (PG) Response to Exercise|PG at start of exercise minus the subsequent PG nadir|Begins at start of exercise, at or after 15:00 on the in-patient visit day randomly assigned each subject for exercise; ends at start of the subsequent meal. Median period: 121 minutes (min), interquartile range (IQR): 15 min, range: 93 to 133 min.|All subjects were used for final analysis||mg/dL||Inter-Quartile Range|Median
785975|NCT00831675|Primary|Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation|"Solicited local reactions: Erythema, bruising, induration, pain at injection site.
Solicited systemic reactions: Fever (temperature), irritability, crying, lethargy, appetite decreased, diarrhea, vomiting, rash collected daily for four days after each injection."|Days 0-3 Post-dose|Safety analysis was on all enrolled and vaccinated subjects with available reaction data, intent-to-treat population||Participants|||Number
786221|NCT00839241|Secondary|Hemoglobin||Baseline|||g/dL||Standard Deviation|Mean
785948|NCT00831415|Primary|Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)|Any untoward medical occurrence in a participant who received study treatment was considered an AE without regard to possibility of causal relationship. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be an SAE: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly.|Baseline (Extension Study) up to Day 329 or 15 days after last dose of study treatment|Safety population: all enrolled participants who received at least 1 dose of study treatment in this extension study.||percentage of participants|||Number
785949|NCT00831415|Secondary|Change From Baseline in Clinical Global Impression-Severity of Illness [CGI-S] Score|CGI-S is a 7-point clinician rated scale to assess severity of current illness state. Range is 1 (normal - not ill at all) to 7 (among the most extremely ill). Higher score = more affected.|Baseline (Extension Study) up to Day 308 or FOT Evaluation|ITT; LOCF and Observed cases (non-missing data); (n)=number of participants with analyzable data at observation.||scores on a scale||95% Confidence Interval|Mean
785950|NCT00831415|Secondary|Number of Participants With Categorical Scores on Clinical Global Impression-Improvement (CGI-I)|CGI-I is a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Day 308 or FOT Evaluation|ITT; LOCF. Improvement measured against CGI-I baseline (Day -1) data in Core study (NCT00798707 [3151A1-3359 / B2061003]).||participants|||Number
785951|NCT00831415|Primary|Change From Baseline in Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score|"HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on either a 3-point (0 to 2) or a 5-point scale (0 to 4) with 0=none/absent and 4=most severe, for a maximum total score of 50. Higher scores indicate greater severity. FOT evaluation is defined as the last on-therapy evaluation, regardless of the number of days on therapy. Analysis on Observed cases (non-missing data) and Last observation carried forward (LOCF); LOCF method of imputation for any missing value at any visit."|Baseline (Extension Study) up to Day 308 or Final On-Therapy (FOT) Evaluation|Intent to treat (ITT): all enrolled participants who received at least 1 dose of study treatment in Extension Study and at least 1 available post-baseline evaluation for any endpoint; (n)=number of participants with analyzable data at observation.||scores on a scale||95% Confidence Interval|Mean
785952|NCT00831428|Secondary|Mini Nasal Lavage||This test will be performed prior to entering the pool, and on exiting the pool||||||
785953|NCT00831428|Secondary|Skin Prick Test||This test will be performed once on a district and once on a national squad training day||||||
785954|NCT00831428|Secondary|Nasal Nitric Oxide||This test will be performed prior to entering the pool, and on exiting the pool||||||
785955|NCT00831428|Primary|Tidal Nitric Oxide||This test will be performed prior to entering the pool, and on exiting the pool|Data from all participants was analysed||ppb||95% Confidence Interval|Geometric Mean
785956|NCT00831428|Secondary|Sport-based Challenge||This test will be performed once on a district and once on a national squad training day||||||
785957|NCT00831428|Secondary|Mannitol Challenge||This test will be performed once on a district and once on a national squad training day||||||
785958|NCT00831441|Secondary|Event Rate of All Bleeding Reported by the Investigator During the Treatment Period - Treated Participants|Bleeding events were adjudicated by the Adjudication Committee and classified according to Thrombolysis in Myocardial Infarction (TIMI) major, minor, minimal, and International Society on Thrombosis and Hemostasis (ISTH) major and clinically relevant non-major bleeding (CRNM) criteria. The adjudicated results based on TIMI and ISTH classifications, and programmatically identified events (not adjudicated) according to Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) classification were used in the analyses of bleeding endpoints. GUSTO Bleed Criteria included Severe or life-threatening: Intracranial hemorrhage, or bleeding that causes hemodynamic compromise requiring intervention; Moderate: Bleeding that requires a blood transfusion, but does not result in hemodynamic compromise; Mild: Bleeding that does not meet criteria for either severe or moderate bleeding. Treatment Period=events with onset from first dose to last dose plus 2 days.|From first dose to first occurrence of event (Bleeding) during Treatment Period (first dose to last dose + 2 days), up to March 2011, approximately 2 years|All participants who received at least one dose of blinded study drug and signed informed consent were analyzed.||percentage of participants/100-pt years|||Number
785959|NCT00831441|Secondary|Event Rate of Confirmed Major Bleeding or Clinically Relevant Non-Major Bleeding (CRNM) Using ISTH Criteria During the Treatment Period - Treated Participants|ISTH Major bleed: acute clinically overt bleeding accompanied by one or more of the following: A decrease in Hgb of 2 g/dL or more over 24 hours; A transfusion of 2 or more units of packed RBCs; Bleeding that occurs in at least one of the following critical sites: intracranial, intraspinal, intraocular (within the corpus of the eye), pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal; Bleeding that was fatal. CRNM: acute clinically overt bleeding that did not satisfy additional criteria required for the bleeding event to be defined as a major bleeding event and meets at least one of the following: Hospital admission for bleeding; Physician guided medical or surgical treatment for bleeding; Change in anti-thrombotic treatment (anticoagulant or antiplatelet) therapy. Bleeding events were adjudicated by the Adjudication Committee. Treatment Period=events with onset from first dose to last dose plus 2 days.|From first dose to first occurrence of event (ISTH major or CRNM bleed) during Treatment Period (first dose to last dose + 2 days), up to March 2011, approximately 2 years|All participants who received at least one dose of blinded study drug and signed informed consent were analyzed.||percentage of participants/100-pt years|||Number
785976|NCT00831701|Secondary|Number of Participants Requiring Active Treatment|The number of participants requiring active treatment was recorded. Shock wave lithotrypsy (SWL), ureterorenoscopy (URS) or insertion of an ureteral catheter were considered as active treatment.|21 days|||participants|||Number
785977|NCT00831701|Secondary|Maximum Daily Pain Score|All patients kept a diary to record the score of every painful episode on a 10-cm visual analogue scale (0= no pain at all; 10= strongest pain one can imagine).|Until stone expulsion or up to 21 days|||Units on a scale||Full Range|Median
786222|NCT00839241|Secondary|TNF-Alpha||Day 8 postop|||pg/mL||Standard Deviation|Mean
786223|NCT00839241|Secondary|TNF-Alpha||Day 5 postop|||pg/mL||Standard Deviation|Mean
785960|NCT00831441|Secondary|Event Rate of Confirmed Major Bleeding Using International Society on Thrombosis and Hemostasis (ISTH) Criteria During the Treatment Period - Treated Participants|ISTH Criteria: Acute clinically overt bleeding defined as new onset, visible bleeding or signs or symptoms suggestive of bleeding confirmed by imaging techniques, which can detect the presence of blood (eg, ultrasound, CT, MRI). Major bleeding: acute clinically overt bleeding accompanied by one or more of the following: A decrease in Hgb of 2 g/dL or more over 24 hours; A transfusion of 2 or more units of packed red blood cells (RBCs); Bleeding that occurs in at least one of the following sites: intracranial, intraspinal, intraocular (within the corpus of the eye; thus, a conjunctival bleed is not an intraocular bleed), pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal; Bleeding that was fatal. Bleeding events were adjudicated by the Adjudication Committee. Event rate was percent of participants with an event (number with event/number randomized) per 100-pt years. Treatment Period=events with onset from first dose to last dose plus 2 days.|From first dose to first occurrence of event (ISTH major bleed) during Treatment Period (first dose to last dose + 2 days), up to March 2011, approximately 2 years|All participants who received at least one dose of blinded study drug and signed informed consent were analyzed.||percentage of participants/100-pt years|||Number
785961|NCT00831441|Primary|Event Rate of Confirmed Major Bleeding Using Thrombolysis in Myocardial Infarction (TIMI) Criteria During the Treatment Period - Treated Participants|TIMI Major Bleed Criteria: Fatal bleeding, intracranial hemorrhage, and clinically overt bleeding with a hemoglobin (Hgb) drop of ≥ 5 grams per deciliter (g/dL), or ≥15% absolute decrease in hematocrit. To account for transfusions, Hgb measurements were adjusted for transfusions. A transfusion of 1 unit of blood was assumed to result in an increase by 1 g/dL in Hgb or 3% in hematocrit. Event rate was percent of participants with an event of Major Bleed as per TIMI (number of participants with event/number randomized) per 100 patient (100-pt) years. Only events confirmed by the adjudication committee were included in the analyses. Treatment Period=events with onset from first dose to last dose plus 2 days.|From first dose to first occurrence of event (TIMI major bleeding) during Treatment Period (first dose to last dose + 2 days), up to March 2011, approximately 2 years|All participants who received at least one dose of blinded study drug and signed informed consent were analyzed.||percentage of participants/100-pt years|||Number
785962|NCT00831441|Secondary|Event Rate of Composite of All-Cause Death, Myocardial Infarction, or Stroke During the Intended Treatment Period - Randomized Participants|"Cause of death was determined by the principal condition that caused the death, not the immediate mode of death.
CV death: included deaths due to CV causes. Non-CV death: included non-CV deaths caused primarily by a malignancy, infection, bleeding, trauma, non-CV system organ failure, or non-CV surgery. Unknown: included deaths that were not attributable to one of the above categories of CV death or to a non-CV cause. MI accounted whether the participant had a recent PCI or CABG surgery. Diagnosis of stroke required a new, non-traumatic, focal neurological deficit of sudden onset, lasting at least 24 hours that was not due to a readily identifiable non-vascular cause. Only events confirmed by the adjudication committee were included in analyses. Intended Treatment Period: Day of randomization (Day 1) to efficacy cut-off date (notification of study termination)."|Randomization (Day 1) to first event (All Cause Death, MI, or Stroke), up to March 2011, approximately 2 years|All randomized participants were analyzed.||percentage of participants/100-pt years|||Number
785963|NCT00831441|Secondary|Event Rate of Composite of Cardiovascular Death, Fatal Bleed, Myocardial Infarction, or Stroke During the Intended Treatment Period - Randomized Participants|Event rate was percent of participants with an event of CV death, fatal bleed, MI, or stroke (number of participants with event/number randomized) per 100 patient (100-pt) years. Only events confirmed by the adjudication committee were included in the analyses. CV death included deaths due to CV causes; Diagnosis of stroke required a new, non-traumatic, focal neurological deficit of sudden onset, lasting at least 24 hours that was not due to a readily identifiable non-vascular cause; Fatal bleeding defined as bleeding that Adjudication Committee determined was the primary cause of death or contributed directly to death; MI took into account whether the participant had a recent PCI or CABG surgery. Intended Treatment Period: Day of randomization (Day 1) to efficacy cut-off date (notification of study termination).|Randomization (Day 1) to first event (CV death, Fatal Bleed, MI, or stroke), up to March 2011, approximately 2 years|All randomized participants were analyzed.||percentage of participants/100-pt years|||Number
785964|NCT00831441|Secondary|Event Rate of Composite of Cardiovascular Death, Myocardial Infarction, Unstable Angina, or Ischemic Stroke During the Intended Treatment Period - Randomized Participants|Event rate was percent of participants with an event of CV death, MI, unstable angina (UA), or ischemic stroke (number of participants with event/number randomized) per 100-pt years. Only events confirmed by the adjudication committee were included in the analyses. Each type of event was counted once per participant, but participants could have been counted in multiple categories. Intended Treatment Period: Day of randomization (Day 1) to efficacy cut-off date (notification of study termination).|Randomization (Day 1) to first event (CV death, MI, UA, Ischemic Stroke, up to March 2011, approximately 2 years|All randomized participants were analyzed.||percentage of participants/100-pt years|||Number
785965|NCT00831441|Secondary|Event Rate of Stent Thrombosis During the Intended Treatment Period - Randomized Participants|Stent thrombosis: Definite stent thrombosis considered to have occurred by either angiographic or pathological confirmation; Probable stent thrombosis considered to have occurred in the following cases: any unexplained death within the first 30 days after stent implantation; irrespective of the time after the procedure, any MI that was related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause; Possible stent thrombosis considered to have occurred with any unexplained death from 30 days after intracoronary stenting until end of study (in Year 2). Event rate was percent of participants with an event of stent thrombosis (number with event/number randomized) per 100-pt years. Only events confirmed by the adjudication committee were included in the analyses. Intended Treatment Period: Day of randomization (Day 1) to efficacy cut-off notice of study termination.|Randomization (Day 1) to first event (stent thrombosis), up to March 2011, approximately 2 years|All randomized participants were analyzed.||percentage of participants/100-pt years|||Number
785978|NCT00831701|Secondary|Required Analgesics|Oral diclophenac (up to 3x50 mg pills) as first-line and oral metamizole (up to 8x 500mg pills)as second-line on-demand analgesics were prescribed. All patients were requested to record the required amount of pills per day|Until stone expulsion or up to 21 days|||pills per day||Inter-Quartile Range|Median
786224|NCT00839241|Secondary|TNF-Alpha||Baseline|||pg/mL||Standard Deviation|Mean
785966|NCT00831441|Secondary|Event Rate of Myocardial Infarction (MI) During the Intended Treatment Period - Randomized Participants|MI took into account whether the participant had a recent percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery. Selected key criteria: Elevation of cardiac biomarkers (eg, Creatine Kinase MB fraction (CKMB), Troponin T, Troponin I) above the upper reference limit (URL) plus ischemic symptoms, ECG changes, or imaging evidence of new loss of viable myocardium or new regional wall motion abnormality; Death of CV etiology with new ST-segment elevation or left bundle branch block (LBBB) or fresh intracoronary thrombus by angiography or at autopsy occurring before biomarkers could be obtained or before their appearance in the blood; Following a PCI, elevation of cardiac biomarkers more than 3*URL; Following CABG surgery, elevation of cardiac biomarkers more than 5*URL; New, significant (≥0.04 s) Q waves in ≥2 contiguous leads; Pathologic findings of acute MI. Intended Treatment Period: Day of randomization (Day 1) to efficacy cut-off notice.|Randomization (Day 1) to first event (MI), up to March 2011, approximately 2 years|All randomized participants were analyzed.||percentage of participants/100-pt years|||Number
785967|NCT00831441|Secondary|Event Rate of Stroke During the Intended Treatment Period - Randomized Participants|Event rate was percent of participants with an event of stroke (number of participants with event/number randomized) per 100 patient (100-pt) years. Only events confirmed by the adjudication committee were included in the analyses. Diagnosis of stroke required a new, non-traumatic, focal neurological deficit of sudden onset, lasting at least 24 hours that was not due to a readily identifiable non-vascular cause (ie, brain tumor). All strokes were classified as hemorrhagic (documentation on imaging (eg computed tomography scan or magnetic resonance imaging) of hemorrhage in the cerebral parenchyma, or a subdural or subarachnoid hemorrhage), non-hemorrhagic/ischemic stroke, ischemic stroke with hemorrhagic conversion, or type unknown. Intended Treatment Period: the period that started on the day of randomization (Day 1) and ended at the efficacy cut-off date (notification of study termination).|Randomization (Day 1) to first event (stroke), up to March 2011, approximately 2 years|All randomized participants were analyzed.||percentage of participants/100-pt years|||Number
785968|NCT00831441|Secondary|Event Rate of Unstable Angina (UA) During the Intended Treatment Period - Randomized Participants|Unstable Angina (UA) defined as worsening or recurrent severe or repetitive angina symptoms at rest lasting at least 10 minutes with at least 2 of the following: New and dynamic electrocardiogram (ECG) changes; angina symptoms leading to inpatient hospitalization; angina symptoms leading to an unplanned or urgent cardiac catheterization, with or without revascularization, that showed evidence of hemodynamically and clinically significant stenosis. Event rate was percent of participants with an event of unstable angina (number of participants with event/number randomized) per 100 patient (100-pt) years. Only events confirmed by the adjudication committee were included in the analyses. Intended Treatment Period: the period that started on the day of randomization and ended at the efficacy cut-off date (cut-off date: the date all sites were informed that study drug should be discontinued for all participants, 18 November 2010).|Randomization (Day 1) to first event of UA, up to March 2011, approximately 2 years|All randomized participants were analyzed.||percentage of participants/100-pt years|||Number
785969|NCT00831441|Primary|Event Rate of Cardiovascular Death, Myocardial Infarction, or Ischemic Stroke During the Intended Treatment Period - Randomized Participants|Event rate was percent of participants with an event of cardiovascular (CV) death, myocardial infarction (MI), or ischemic stroke (number of participants with event/number randomized) per 100 patient (100-pt) years. Study was terminated early and last patient, last visit was in Year 2. Only events confirmed by the adjudication committee were included in the analyses. CV death included deaths due to CV causes (eg, cardiogenic shock, heart failure, arrhythmia/sudden death, cardiac rupture, ischemic stroke, pulmonary embolism, venous/arterial thrombotic events) and other sudden deaths for which an alternative cause was not identified. Intended Treatment Period: the period that started on the day of randomization and ended at the efficacy cut-off date (cut-off date: the date all sites were informed that study drug should be discontinued for all participants, 18 November 2010).|Randomization (Day 1) to first event (CV death, MI, ischemic stroke), up to March 2011, approximately 2 years|All randomized participants were analyzed.||percentage of participants/100-pt years|||Number
785970|NCT00831480|Primary|Disease Progression Diagnosed by Biopsy|Clinical progression validated by biopsy of metastatic site. Progression-free survival (PFS) will be measured from the post-op treatment start date to either the date the patient is first recorded as having disease progression, or the date of death if the patient dies due to any causes before progression. If a patient is lost to follow-up or removed for toxicities, the patient will be censored as of the last date of contact. Patients who start a new treatment before they progress will be censored as of the date of start of the new treatment. If a patient has not progressed or died, PFS is censored at the date of last follow-up. Patients removed from therapy with everolimus due to toxicities will not be included in the PFS estimation.|up to one year|||participants|||Number
785971|NCT00831493|Primary|Maximum Tolerated Dose (MTD) of Vorinostat + Chemoradiation|MTD is maximum dose at which 6 patients are treated and there is at most 1 patient with dose limiting toxicities (DLT). Toxicities graded according to the Common Terminology Criteria for Adverse events (CTCAE).|Toxicity assessment at 6 weeks following chemoradiation (6 weeks)|Analysis per protocol; Of the three participants enrolled only two were eligible for MTD calculation.||mg|||Number
785972|NCT00831675|Other Pre-specified|Percentage of Participants With a 4-Fold Increase in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination (Seroconversion)|Seroconversion defined as the percentage of participants with a ≥ 4-fold increases in titer from pre- to post-vaccination with Fluzone®.|Day 14 post-vaccination|Seroconversion were evaluated in the per-protocol population.||Percentage of Participants|||Number
785973|NCT00831675|Other Pre-specified|Percentage of Participants With at Least a 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination (Seroprotection)|Seroprotection defined as percentage of participants with reciprocal hemagglutination inhibition titers ≥40 post-vaccination with Fluzone®.|14 days post-vaccination|Seroprotection were evaluated in the per-protocol population||Percentage of Participants|||Number
785974|NCT00831675|Other Pre-specified|Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-Vaccination With Fluzone® Vaccine 2004-2005 Pediatric Formulation||14 days post-vaccination|GMTs were evaluated in the per-protocol population||Titers||95% Confidence Interval|Geometric Mean
786225|NCT00839241|Secondary|Interleukin-10||Day 8 postop|||pg/mL||Standard Deviation|Mean
786226|NCT00839241|Secondary|Interleukin-10||Day 5 postop|||pg/mL||Standard Deviation|Mean
786227|NCT00839241|Secondary|Interleukin-10||Baseline|||pg/mL||Standard Deviation|Mean
785979|NCT00831701|Secondary|Time to Stone Passage|The patient-defined time of stone expulsion was considered the event for time to stone passage. Patients with unnoticed stone expulsion were censored at the date of last positive stone status, and those who discontinued the therapy were censored at the date of last medication intake. Kaplan-Meier estimates were computed for time to stone passage.|21 days|||days||Inter-Quartile Range|Median
785980|NCT00831701|Primary|Number of Participants With Stone Expulsion|The primary end point was the number of patients per group experiencing stone expulsion until day 21, as confirmed by low-dose abdominal computed tomography (CT).|21 days|||Participants|||Number
785981|NCT00831753|Secondary|Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.|"Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability.
Grade 3 reactions were defined as: Pain, cries when injected limb is moved or movement of injected limb is reduced; Erythema and Swelling ≥ 5 cm; Pyrexia > 39.5ºC; Vomiting ≥ 6 episodes per 24 hour or requiring parenteral hydration; Crying, > 3 hours; Somnolence, sleeping most of the time or difficult to wake up; Anorexia refuses ≥ 3 feeds/meals or refuses most feeds/meals; Irritability inconsolable."|Day 0 up to Day 7 after each injection|Solicited reactions were assessed in all participants who received at least one dose of investigational or control vaccine, according to the vaccine actually received (Safety Analysis Population).||Participants|||Number
785982|NCT00831753|Secondary|Geometric Mean Titers (GMTs) of Antibodies to Vaccine Antigens After a Primary Series of Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.|Antibody titers were measured by chemiluminescence detection for hepatitis B (Hep B), by Farr type radioimmunoassay for Haemophilus influenzae type b (PRP), and by toxin neutralization test for diphtheria.|Day 150 (1 month after dose 3)|Antibody GMTs were assessed in all participants who did not have any protocol violation that might have interfered with primary criteria evaluation (Per-Protocol Population).||Titers (1/dilutions)||95% Confidence Interval|Geometric Mean
785983|NCT00831753|Primary|Number of Participants Achieving Seroprotection to Vaccine Antigens After a Primary Series Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.|"Antibody titers were measured by chemiluminescence detection for hepatitis B (Hep B), by Farr type radioimmunoassay for Haemophilus influenzae type b (PRP), and by toxin neutralization test for diphtheria. Seroprotection criteria were defined as:
Criteria 1: Anti-Hep B titer ≥ 10 mIU/mL; Anti-PRP titer ≥ 0.15 µg/mL; Anti-diphtheria titer ≥ 0.01 IU/mL.
Criteria 2: Anti-Hep B titer ≥ 100 mIU/mL; Anti-PRP titer ≥ 1 µg/mL; Anti-diphtheria titer or ≥ 0.1 IU/mL."|Day 150 (1 month after dose 3)|Seroprotection was assessed in all participants who did not have any protocol violation that might have interfered with primary criteria evaluation (Per-Protocol Population).||Participants|||Number
785984|NCT00831753|Primary|Number of Participants Achieving Seroprotection for Anti Hep-B After a Primary Series of Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™|Anti-hepatitis B (Hep B) antibodies were measured by chemiluminescence detection. Seroprotection was defined as a titer ≥ 10 mIU/mL.|Day 150 (1 month after dose 3)|Seroprotection against Hep B was assessed in all participants who did not have any protocol violation that might have interfered with primary criteria evaluation (Per-Protocol Population).||Participants|||Number
785985|NCT00831766|Other Pre-specified|Median Relapse-Free Survival (RFS)|Relapse-Free Survival (RFS), defined for those patients who have achieved CR or CRi as the time from study entry to disease progression, relapse or death due to any cause, whichever is earlier, will be analyzed similarly. Descriptive analysis was planned for this measure.|24 Months||||||
785986|NCT00831766|Other Pre-specified|Median Overall Survival (OS)|Overall Survival (OS), defined for those patients who have achieved CR or CRi as the time from study entry to disease progression, relapse or death due to any cause, whichever is earlier, to be analyzed similarly. Descriptive analysis was planned for this measure.|24 Months||||||
785987|NCT00831766|Other Pre-specified|Rate of Cytogenetic Remission Following Induction Therapy|Rate of cytogenetic remission following induction therapy. Descriptive analysis was planned for this measure.|24 Months||||||
785988|NCT00831766|Secondary|Median Progression-Free Survival (PFS)|Progression-free survival (PFS), defined as the time from study entry to disease progression, relapse, or death due to any cause, whichever is earlier, will be summarized with the Kaplan-Meier curve.|24 months||02/2018||||
785989|NCT00831766|Secondary|Rate of Lenalidomide Related Toxicity During Maintenance Therapy|Rate of toxicities of lenalidomide as maintenance therapy according to the National Cancer Institute Common Toxicity Criteria (CTC) V3.|24 months||02/2018||||
785990|NCT00831766|Primary|Phase II: Complete Response Rate of Participants Treated at Maximum Tolerated Dose (MTD)|Percentage of participants achieving CR/CRi. Complete Response (CR) plus Complete Response with Incomplete Count Recovery (CRi) rates. Response rates (CR + CRi) of lenalidomide following idarubicin and cytarabine induction therapy in older patients with previously untreated AML. A CR designation requires that the patient achieve the morphologic leukemia-free state and have an absolute neutrophil count of more than 1,000/μL and platelets of 100,000/μL. CRi: After chemotherapy, patients fulfill all of the criteria for CR except for residual neutropenia (1,000/μL) or thrombocytopenia (100,000/μL).|24 months|All participants treated at MTD||percentage of participants|||Number
785991|NCT00831766|Primary|Phase I: Recommended Phase II Dose|For the Phase I component, no formal statistical analysis was planned. The primary endpoint is to determine the maximum tolerated dose (MTD) and recommended Phase II dose of lenalidomide given in combination with standard idarubicin + cytarabine induction therapy.|18 months|Phase I participants.||mg/day|||Number
785992|NCT00831779|Secondary|Adjusted Mean Change From Baseline in Insulin Secretion at Week 12 (Last Observation Carried Forward [LOCF])|Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Measurements were obtained during the randomization visit and Week 12 in the double-blind period.|From Baseline to Week 12|All randomized participants who received study medication and had nonmissing values at baseline and Week 12 (LOCF)||mU/L*min||Standard Error|Mean
786060|NCT00832572|Secondary|Assess Participant Quality of Life Utilizing the Short Form 36 Health Survey (SF-36v2) Questionnaire|The participant quality of life assessed utilizing the SF-36v2 questionnaire|Baseline to Week 6|Study was stopped and no analyses were performed on the secondary outcome measures.|||||
785993|NCT00831779|Primary|Adjusted Mean Percent Change From Baseline in Insulin Sensitivity at Week 12 (Last Observation Carried Forward [LOCF])|Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Measurements were obtained during the randomization visit and Week 12 in the double-blind period.|From Baseline to Week 12|All randomized participants who received study medication and had nonmissing values at baseline and Week 12 (LOCF)||% Change of Baseline Insulin Sensitivity||Standard Error|Mean
785994|NCT00831844|Primary|Disease Response|Response rates will be calculated as the percent of patients whose best response is a Complete Response (CR) or Partial Response (PR).|First six treatment cycles - 24 weeks|Grp 2, 12 enrolled 1 ineligible, 1 progressive disease prior to first dose of therapy. Grp 3, 21 enrolled, 1 ineligible. Grp 5, 14 enrolled, 1 ineligible. Grp 8, 10 enrolled, 1 not evaluable (patient didn't receive any drug).||patient|||Number
785995|NCT00831987|Primary|Percentage of Participants With at Least a 4-Fold Increase in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination||Day 21 post-vaccination|||Percentage of Participants|||Number
785996|NCT00831987|Primary|Percentage of Participants With at Least 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination||21 Days post-vaccination|||Percentage of Participants|||Number
785997|NCT00831987|Primary|Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-Vaccination With Fluzone® Vaccine|GMTs and their 95% Confidence Intervals for each of the 3 antigens pre- and post-vaccination with Fluzone® 2004-2005 formulation.|Day 0 and Day 21 Post-Vaccination|Geometric Mean Titers were assessed in the per-protocol population||Titers||95% Confidence Interval|Geometric Mean
785998|NCT00831987|Primary|Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination|"Solicited local reactions: Erythema (redness), Induration, Bruising, and Pain at the injection site.
Solicited systemic events: Fever (temperature), Chills, Rash, Headache, Cough, Runny nose, Nausea, Vomiting, Diarrhea, Malaise, Myalgia, and Arthralgia"|0 to 3 days post-vaccination|||Percentage of Participants|||Number
785999|NCT00832000|Secondary|Short Form 36 - Mental Composite Score|The SF-36 is a standard quality of life instrument. The mental composite score represents the the mental burden on quality of life and is a summary of questions related to mental impact of a disease or condition (mental function, role emotional, vitality, and mental health). The score is nomralized to the population and ranges from 0-100, with the US normal value of 50. A lower score represents a greater impact of quality of life.|The end of period 1 (week 4) and period 2 (week 9)|Modified intention to treat analysis (n=57). 2 subjects were excluded from analysis due to failure call the IVR system in either period. Treatment group estimates by period are taken from the mixed model, the number above reflecting the number who contributed to the model point estimate. Confidence intervals are bootstrap confidence intervals.||units on a scale||95% Confidence Interval|Mean
786000|NCT00832000|Secondary|Short Form 36 - Physical Composite Score|The SF-36 is a standard quality of life instrument. The physical composite score represents the the physical burden on quality of life and is a summary of questions related to physical impact of a disease or condition (physical function, role physical, bodily pain, and general health). The score is nomralized to the population and ranges from 0-100, with the US normal value of 50. A lower score represents a greater impact of quality of life.|Particiapnts who experienced weakness on mexiletine in either period 1 or period 2.|All participants with SF-36 physical composite values in either period 1 or period 2 were included in analysis. The treatment-specific group mean is taken from the mixed model. Confidence intervals are bootstrap confidence intervals.||units on a scale||95% Confidence Interval|Mean
786001|NCT00832000|Secondary|Individualized Neuromuscular Quality of Life Scale - Summary Score|Quality of life scale for patinets with neuromuscular disorders. The INQoL summary score is a weighted average made up of 5 subdomains (activities, social relationships, independence, emotions, and body image) which document the impact of a disease on a patients' quality of life. Scores range from 0-100, and can be interpreted as the percent of maximal detrimental impact on quality of life. A higher score indicates more detrimental impact.|The end of period 1 (week 4) and period 2 (week 9)|All participants with INQoL summary score values in either period 1 or period 2 were included in analysis. The treatment-specific group mean is taken from the mixed model. Confidence intervals are bootstrap confidence intervals.||units on a scale||95% Confidence Interval|Mean
786002|NCT00832000|Secondary|Compound Motor Action Potentials After Long Exercise Test|Compound muscle action potential (CMAP) after long periods of exercise as a percentage of baseline.|The end of period 1 (week 4) and period 2 (week 9)|All participants with long exercise test values in either period 1 or period 2 were included in analysis. The treatment-specific group mean is taken from the mixed model. Confidence intervals are bootstrap confidence intervals.||percentage of baseline CMAP amplitude||95% Confidence Interval|Mean
786003|NCT00832000|Secondary|Graded Myotonia by Needle Electromyography - Right Tibialis Anterior|Measured the amount of myotonia present on needle exam by assigning a number 1-3, with 1 being minimal amount of myotonia on needle stick and 3 being maximal amount of myotonia present on needle stick.|The end of period 1 (week 4) and period 2 (week 9)|All participants with graded needle EMG of the RTA values in either period 1 or period 2 were included in analysis. The treatment-specific group mean is taken from the mixed model. Confidence intervals are bootstrap confidence intervals.||units on a scale||95% Confidence Interval|Mean
786004|NCT00832000|Secondary|Clinical Eye Closure Myotonia Evaluation (Seconds)|Time to open the eyes after forced eye closure as measured on a stopwatch.|The end of period 1 (week 4) and the end of period 2 (week 9)|All participants with clinical eye closure myotonia values in either period 1 or period 2 were included in analysis. The treatment-specific group mean is a geometric-like mean. Confidence intervals are bootstrap confidence intervals.||Seconds||95% Confidence Interval|Mean
786005|NCT00832000|Secondary|Clinical Hand Grip Myotonia Evaluation (Seconds)|The time to open the fist after a forced handgrip as measured on a stopwatch.|The end of period 1 (week 4) and the end of period 2 (week 9)|All participants with clinical handgrip myotonia values in either period 1 or period 2 were included in analysis. The treatment-specific group mean is a geometric-like mean. Confidence intervals are bootstrap confidence intervals.||Seconds||95% Confidence Interval|Mean
786061|NCT00832572|Primary|Reduction in Neuropathic Pain|Reduction in patient-reported neuropathic pain (by 2 numeric levels as measured by the Numeric Pain Scale)|Baseline to Week 6|Study was stopped and no analysis was performed on the primary outcome measure.|||||
786006|NCT00832000|Secondary|Graded Myotonia by Needle Electromyography - Right Abductor Digiti Minimi|Measured the amount of myotonia present on needle exam by assigning a number 1-3, with 1 being minimal amount of myotonia on needle stick and 3 being maximal amount of myotonia present on needle stick.|The end of period 1 (week 4) and period 2 (week 9)|All participants with graded needle EMG of the RADM values in either period 1 or period 2 were included in analysis. The treatment-specific group mean is taken from the mixed model. Confidence intervals are bootstrap confidence intervals.||units on a scale||95% Confidence Interval|Mean
786007|NCT00832000|Secondary|Compound Motor Action Potentials After Short Exercise Test|The maximal post-exercise compound muscle action potential (CMAP) after short periods of exercise as a percent of the baseline measurement.|The end of period 1 (week 4) and period 2 (week 9)|All participants with short exercise test values in either period 1 or period 2 were included in analysis. The treatment-specific group mean is taken from the mixed model. Confidence intervals are bootstrap confidence intervals.||percentage of baseline CMAP amplitude||95% Confidence Interval|Mean
786008|NCT00832000|Secondary|Quantitative Measure of Hand Grip Myotonia (Seconds)|Maximum voluntary contractions following forced right hand grip were recorded and the time to relax from 90% to 5% of average maximal force was determined using automated analysis software.|The end of period 1 (week 4) and period 2 (week 9)|All participants with quantitative handgrip myotonia values in either period 1 or period 2 were included in analysis. The treatment-specific group mean is a geometric-like mean using log (t+0.1) 'normalizing' transformation. Confidence intervals are bootstrap confidence intervals.||seconds||95% Confidence Interval|Mean
786009|NCT00832000|Secondary|Patient Reported Tiredness on the IVR|Tiredness measured on a 1-9 scale, 1 being minimal, 9 the worst ever experienced. 0=no symptom reported. For analysis the average severity of tiredness for each participant was calculated from daily calls made in weeks 3-4 of each period.|Weeks 3-4 of each period|49 partipants who experienced tiredness in either period 1 or period 2 were included in analysis. All treatment group means are extracted from the mixed effects model. Confidence intervals are bootstrap confidence intervals.||units on a scale||95% Confidence Interval|Mean
786010|NCT00832000|Secondary|Patient Reported Weakness on the IVR|Weakness measured on a 1-9 scale, 1 being minimal, 9 the worst ever experienced. 0=no symptom reported. For analysis the average severity of weakness for each participant was calculated from daily calls made in weeks 3-4 of each period.|Weeks 3-4 of each period|44 partipants who experienced weakness in either period 1 or period 2 were included in analysis. All treatment group means are extracted from the mixed effects model. Confidence intervals are bootstrap confidence intervals.||units on a scale||95% Confidence Interval|Mean
786011|NCT00832000|Secondary|Patient Reported Pain on the IVR|Pain measured on a 1-9 scale, 1 being minimal, 9 the worst ever experienced. 0=no symptom reported. For analysis the average severity of pain for each participant was calculated from daily calls made in weeks 3-4 of each period.|Weeeks 3-4 of each period|48 partipants who experienced pain in either period 1 or period 2 were included in analysis. All treatment group means are extracted from the mixed effects model. Confidence intervals are bootstrap confidence intervals.||units on a scale||95% Confidence Interval|Mean
786012|NCT00832000|Primary|Patient-reported Stiffness on the IVR|Stiffness measured on a 1-9 scale, 1 being minimal, 9 the worst ever experienced. 0=no symptom reported. For analysis the average severity of stiffness for each participant was calculated from daily calls made in weeks 3-4 of each period.|Weeks 3-4 of each period|Modified intention to treat analysis (n=57). 2 subjects were excluded from analysis due to failure call the IVR system in either period. Treatment group estimates by period are taken from the mixed model, the number above reflecting the number who contributed to the model point estimate. Confidence intervals are bootstrap confidence intervals.||units on a scale||95% Confidence Interval|Mean
786013|NCT00832078|Secondary|Haematuria||After each catheterisation||||||
786014|NCT00832078|Secondary|Preference||At study termination||||||
786015|NCT00832078|Secondary|Handling||After each catheterisation||||||
786016|NCT00832078|Primary|Discomfort|Discomfort measured on a Visual Analog Scale (VAS) from 0 (no discomfort) to 10 (worst imaginable discomfort)|After each catheterisation|The number analized was the number of participants catherised with each catheter at least onze during the study(SC or SCCM)||units on a scale||Standard Deviation|Mean
786017|NCT00832091|Secondary|Wound Healing (Wound Closure Without Drainage) by Applying Tβ4 Gel Once Daily for up to 84 Days to Patients With Venous Stasis (VS) Ulcers|Wound healing effectiveness of Tβ4 gel applied once daily for up to 84 days to patients expressed as the number of patients whose wound had closed without drainage at the end of the study, Day 84|Up to 84 days|Analysis per protocol, Intent-to-treat (ITT), using Last Observation Carried Forward (LOCF)||Participants|||Number
786018|NCT00832091|Primary|Safety and Tolerability of Thymosin Beta 4 (Tβ4) Applied to Patients With Venous Stasis (VS) Ulcers for up to 84 Days|All Treatment-Emergent (TE) Serious Adverse Events (SAEs) and Adverse Events (AEs) by treatment with Tβ4 gel at the combined 3 doses in the safety population with Venous Stasis (VS) ulcers for up to 84 days. TEAE is defined as a side effect that begins or that worsens in severity after the application of at least one dose of Tβ4 gel on the venous stasis ulcer. A pre-existing condition is not considered an AE, but if it worsens during the study, then it may be considered an AE|Up to 84 days|Analysis per protocol, ITT, using LOCF||SAEs and AEs|||Number
786019|NCT00832117|Secondary|Number of Participants With Laboratory Abnormalities Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria|Grade (Gr) 1=Mild, 2=Moderate, 3=Severe/medically significant, 4=Life-threatening. Hemoglobin Gr1 <LLN - 10.0 g/dL; Gr2 <10.0 - 8.0 g/dL; Gr3 <8.0 - 6.5 g/dL; Gr4 <6.5 g/dL. White Blood Cell Count (WBC) Gr1 <lower limit of normal (LLN) - 3000/mm^3; Gr2 <3000 - 2000/mm^3; Gr3 <2000 - 1000/mm^3; Gr4 <1000/mm^3. Absolute Neutrophil Count (ANC) Gr 1 <LLN - 1500/mm^3; Gr 2 <1500 - 1000/mm^3; Gr3 <1000 - 500/mm^3; Gr 4 <500/mm^3. Platelets Gr1 <LLN - 75,000/mm^3; Gr2 <75,000 - 50,000/mm^3; Gr3 <50,000 - 25,000/mm^3; Gr4 <25,000/mm^3. Normal ranges vary by local laboratory.|Assessed at screening and weekly during treatment. Median time on study therapy was 18 weeks (range: 6-69 weeks) for ixa 32 mg/m^2+cis 60 mg/m^2 arm; 6 weeks (range: 3-18 weeks) for ixa 32mg/m^2+cis 80 mg/m^2.|All treated participants||participants|||Number
786062|NCT00832585|Secondary|Change in Physician Global Assessment (PGA) Score From Baseline (Week 1) to Week 16.|The Physician Global Assessment (PGA) evaluates the overall severity of Atopic Dermatitis (AD) at a given time using a four point scale (0=clear, 0.5=clear to mild, 1=mild, 1.5=mild to moderate, 2=moderate, 2.5=moderate to severe, and 3=severe).|Week 1 to week 16|||Scores on a scale||Full Range|Median
786020|NCT00832117|Secondary|Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria|AE=any new untoward medical occurrence/worsening of a preexisting medical condition that does not necessarily have a causal relationship with treatment. SAE=any untoward medical event that results in death, persistent/significant incapacity, drug dependency or abuse; is life-threatening, an important medical event, a congenital anomaly/birth defect; requires/prolongs inpatient hospitalization. Treatment related=possibly, probably, or certainly related to and of unknown relationship to study treatment. Grade 1=Mild, 2=Moderate, 3=Severe/medically significant, 4=Life-threatening.|Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on study therapy was 18 weeks (range: 6-69 weeks) for ixa 32 mg/m^2+cis 60 mg/m^2 arm; 6 weeks (range: 3-18 weeks) for ixa 32mg/m^2+cis 80 mg/m^2.|All treated participants||participants|||Number
786021|NCT00832117|Secondary|Duration of Response in Participants With Non-small Cell Lung Cancer (NSCLC)|The duration of response will be computed for all treated subjects whose best response is either partial response (PR) or complete response (CR). The duration of response is measured from the time (in months) measurement criteria are first met for PR or CR, whichever is recorded first, until the date of documented progressive disease or death. Subjects who neither relapse nor die will be censored on the date of their last tumor assessment.|The duration of response is measured from the time (in months) measurement criteria are first met for PR or CR, whichever is recorded first, until the date of documented progressive disease or death. (Duration of study was approximately 21 months.)|This outcome measure was not analyzed as the indication for NSCLC is no longer being pursued.|||||
786022|NCT00832117|Secondary|Percentage of Participants With Response|Response in participants with non-small cell lung cancer (NSCLC) was defined as the number of subjects in whose best response is partial response (PR) or complete response (CR) (see Outcome Measure 3 for definitions) divided by the total number of response evaluable subjects.|At End-of-Treatment visit. Median time on study therapy was 18 weeks (range: 6-69 weeks) for ixa 32 mg/m^2+cis 60 mg/m^2 arm; 6 weeks (range: 3-18 weeks) for ixa 32mg/m^2+cis 80 mg/m^2 arm.|This outcome measure was not analyzed as the indication for NSCLC is no longer being pursued.|||||
786023|NCT00832117|Primary|Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D) of Cisplatin in Combination With Ixabepilone, 32 mg/m^2|The MTD is defined as the highest dose level in which dose limiting toxicities (DLTs) during the first 21 days of the first treatment cycle are observed in less than 1 out of 3 or less than 2 out of 6 treated subjects with at least 2 subjects experiencing DLT at the next higher dose level.|Within the first 21 days of first cycle|All subjects who received at least 1 dose of either ixabepilone or carboplatin||mg/m^2|||Number
786024|NCT00832117|Secondary|Number of Participants With Best Response As Assessed With Response Evaluation Criteria in Solid Tumors (RECIST)|Complete Response(CR):Disappearance of all clinical/radiological evidence of target lesions (TL) & all nontarget lesions (NTL) + no new lesions (NWL). Partial Response(PR):CR of TL + persistence of >=1 NTL (NonCR/NonPD) + no NWL; OR >=30% decrease in sum of longest diameter(LD) of all TL + CR or NonCR/NonPD in NTL + no NWL. Progressive Disease (PD):>=20% increase in sum of LD of TL regardless of NTL & NWL status; or unequivocal progression of NTL regardless of TL & NWL status; or NWL regardless of TL & NTL status. Stable Disease(SD): Neither PD nor PR in TL + CR or NonCR/NonPD in NTL + no NWL.|At End-of-Treatment visit. Median time on study therapy was 18 weeks (range: 6-69 weeks) for ixa 32 mg/m^2+cis 60 mg/m^2 arm; 6 weeks (range: 3-18 weeks) for ixa 32mg/m^2+cis 80 mg/m^2 arm.|All treated participants||participants|||Number
786025|NCT00832117|Primary|Participants Experiencing Dose Limiting Toxicity (DLT)|DLT=any of the following treatment-related events:Grade(Gr)3/4 diarrhea despite the use of adequate/maximal medical intervention and/or prophylaxis;other Gr3 or greater nonhematological toxicity requiring removal from further study therapy;delayed recovery from treatment-related toxicity delaying scheduled retreatment for >3 weeks;Gr4 neutropenia (absolute neutrophil count <500 cells/mm^3) for >=5 consecutive days or Gr3/4 neutropenia of any duration with sepsis or fever >38.5°C;thrombocytopenia <25,000 cells/mm^3 or bleeding requiring platelet transfusion. Grades defined in Outcome Measure 7.|Within the first 21 days of first cycle|all treated participants||participants|||Number
786026|NCT00832130|Primary|Tear Break-up Time|Tear break-up time measured under a slit lamp biomicroscope following instillation of fluorescein dye in the eye. Time was measured in seconds with a maximum of 20. Higher tear break-up time indicates better tear film stability.|Baseline, 2 Weeks and 4 Weeks|Results presented are for the Per Protocol population. 4 Weeks data for the Warm Compress Control group are after crossover.||Seconds|Participants|Standard Deviation|Mean
786027|NCT00832130|Secondary|Discomfort Evaluation (Discomfort/Pain Score)|Subject-reported numeric score reflecting low or high intensity. Scores ranged from 0 to 10, with 0 being no discomfort or pain and 10 being intolerable pain.|Treatment and 1 Day|Results presented are of the Intent to Treat population. Only the Manual Mini group underwent a 1 day assessment.||Scores on a scale|Participants|Standard Deviation|Mean
786028|NCT00832130|Secondary|(LogMAR) Best Spectacle Corrected Visual Acuity|Measurement of BSCVA at a distance using a logMAR chart under standard illumination. The logMAR ranged from -0.30 to 1.0. A lower logMAR value is a better visual acuity.|Baseline, 2 Weeks and 4 Weeks|Results presented are of the Intent to Treat population. 2 Weeks data for the Control group are after control treatment, but before crossover treatment. 4 Weeks data for the Control group are after crossover treatment.||LogMAR|Participants|Standard Deviation|Mean
786029|NCT00832130|Secondary|Intraocular Pressure|Intraocular pressure (IOP) was evaluated by Goldmann applanation tonometry. Change in IOP from Baseline was assessed to confirm safety.|Baseline through 4 Weeks|Results presented are of the Intent to Treat population. Post-Treatment results for the Control group are before crossover treatment. 4 Weeks results for the Control group are after crossover treatment.||mmHg|Participants|Standard Deviation|Mean
786030|NCT00832130|Secondary|Ocular Surface Staining (Corneal Staining Sum Score)|Corneal staining score in five corneal regions, evaluated on a scale from 0 (none), 1 (mild), 2 (moderate) to 3 (severe). The sum of the five corneal staining scores was on a scale from 0 to 15. A lower grade indicates less corneal surface desiccation.|Baseline through 4 Weeks|Results presented are of the Intent to Treat Population. 4 Weeks data for the Control group are after treatment crossover.||Scores on a scale|Participants|Standard Deviation|Mean
786228|NCT00839241|Secondary|Interleukin-6||Day 8 postop|||pg/mL||Standard Deviation|Mean
786229|NCT00839241|Secondary|Interleukin-6||Day 5 postop|||pg/mL||Standard Deviation|Mean
786230|NCT00839241|Secondary|Interleukin-6||Baseline|||pg/mL||Standard Deviation|Mean
786031|NCT00832130|Secondary|Dry Eye Symptoms (Total SPEED Score)|Standard Patient Evaluation of Eye Dryness questionnaire. Assessment of subjects' frequency and severity of dry eye symptoms. The total score was calculated as the sum scores for all symptoms over a range of 0 to 28. A lower total SPEED score represents less frequent and/or less severe symptoms.|Baseline, 2 Weeks and 4 Weeks|Results presented are for the Per Protocol population. 4 Weeks data for the Warm Compress Control group are after crossover.||Scores on a scale|Participants|Standard Deviation|Mean
786032|NCT00832130|Primary|Incidence of Device-related Adverse Events|Number of eyes for which a device-related AE occurred|Baseline through 4 Weeks|Results presented are of the Intent to Treat Population.||Events|Participants||Number
786033|NCT00832130|Primary|Meibomian Gland Assessment (Total Meibomian Gland Secretion Score)|Evaluation of secretion characteristics from the gland orifices along the lower eyelid. Assessment was based on the grading scale: 3 (clear liquid secretion), 2 (cloudy liquid secretion), 1 (inspissated), 0 (no secretion). The total meibomian gland secretion score was the sum of the grades for all 15 glands with a range of 0 to 45.|Baseline, 2 Weeks and 4 Weeks|Results presented are for the Per Protocol population. 4 Weeks data for the Warm Compress Control group are after crossover.||Scores on a scale|Participants|Standard Deviation|Mean
786034|NCT00832260|Secondary|Percentage of Patients in Whom ACap™ Confirm Algorithm is Recommended at a Pulse Width of 0.4 Milliseconds (ms) During All Follow-ups (Implant, Staples Removal, 3, 6, 9 and 12 Months).||12 months|||percentage of patients|||Number
786035|NCT00832260|Primary|Percentage of Patients in Whom ACap™ Confirm Algorithm is Programmed Safely to ON During the First 12 Months.||12 months|||percentage of patients|||Number
786036|NCT00832299|Secondary|Observation of Overall Pathologic Response Rate, Correlation of Pathologic Staging With Pre-op Ultrasound and Pelvic MRI Staging Observed Toxicities Patterns of Disease Relapse Disease-free Survival Overall Survival||5 years||||||
786037|NCT00832299|Primary|Pathologic Complete Response||3-6 months|Because only 2 subjects were enrolled, no analysis was performed. There is no data to report.|||||
786038|NCT00832338|Primary|Pathologic Response to Pre-operative Docetaxel and Cytoxan (TC)|"Patients were assessed for surgery after 6 cycles of TC (18 weeks). Pathologic stage was determined based on size of tumor and degree of lymph node involvement at the time of surgery, whereas clinical stage pre-operatively was determined by clinical assessment and imaging.
If pathologic stage was the same as clinical stage, it was called stable; if it was higher, upstaged (worse outcome); if lower, downstaged (better outcome). Pathologic stage was determined by Emory board-certified pathologists."|At time of definitive surgery|Staging information was not collected for two patients.||Participants|||Count of Participants
786039|NCT00832377|Other Pre-specified|Baseline IOP|"Baseline IOP was measured at ~9 AM of first day of treatment period.
IOP was measured in both eyes and the eye with the higher IOP was used for the participant."|Baseline|||mmHg||Standard Deviation|Mean
786040|NCT00832377|Secondary|Mean Change in IOP 8 Hours After the Study Drug Administration at Week 12 Compared to Baseline IOP|"The therapeutic goal of normal tension glaucoma treatment includes lowering IOP to prevent progression of damage in optic nerves or vision. In this trial, IOP was measured with the same tonometer throughout the study. A decreased IOP from baseline is considered an improvement.
IOP was measured in both eyes and the eye with the higher IOP was used for the participant."|Baseline and 12 weeks|||mmHg||Standard Deviation|Mean
786041|NCT00832377|Secondary|Mean Change in Trough IOP Measured Right Before Study Drug Administration at Week 12 Compared to Baseline IOP.|"The therapeutic goal of normal tension glaucoma treatment includes lowering IOP to prevent progression of damage in optic nerves or vision. In this trial, IOP was measured with the same tonometer throughout the study. A decreased IOP from baseline is considered an improvement.
IOP was measured in both eyes and the eye with the higher IOP was used for the participant."|Baseline and 12 weeks|||mmHg||Standard Deviation|Mean
786042|NCT00832377|Primary|Mean Change in the Peak Intraocular Pressure (IOP) Measured Two Hours After Study Drug Administration at Week 12 Compared to Baseline IOP.|"The therapeutic goal of normal tension glaucoma treatment includes lowering IOP to prevent progression of damage in optic nerves or vision. In this trial, IOP was measured with the same tonometer throughout the study. A decreased IOP from baseline is considered an improvement.
IOP was measured in both eyes and the eye with the higher IOP was used for the participant."|Baseline and 12 weeks|||mmHg||Standard Deviation|Mean
786043|NCT00832390|Primary|Change From Baseline in A1C at Week 24|"Week 24 A1C minus baseline (Week 0) A1C. The unit for A1C is percent. Thus, this measure represents a difference of percent values."|Baseline and 24 Weeks|||Percent Difference||95% Confidence Interval|Mean
786044|NCT00832416|Secondary|Percentage of Participants Who Dropped Out From Trial by Dropout Reason|Reasons for withdrawal from the trial were collected and the percentage of participants who dropped out from trial were calculated by dropout reason|12 weeks|Safety population: all randomized patients who received at least one dose of the assigned study medication.||percentage of participants|||Number
786045|NCT00832416|Primary|Percentage Difference Between WOMAC Physical Function Subscale Score From Baseline to the End of the Study (Week 12)|Percentage of difference in WOMAC Physical Function Subscale score between baseline and week 12. The WOMAC scale is a 24-item questionnaire divided in 3 subscales, using a 100mm visual analog scale ranging from no pain (0mm) to extreme pain (100mm). The WOMAC Physical Function subscale results from the sum of 17 questions.|Baseline to week 12|The analysis was performed using the full analysis population (All randomized patients who received at least one dose of the assigned study medication and had at least one post Baseline assessment of any functional scale). Missing Values at Last Visit Imputed by Individual Last Post Baseline Value.||Percentage difference||Standard Deviation|Mean
786046|NCT00832416|Secondary|Investigator Global Rating of Pain Relief|"The Investigator Global Rating of Pain is a 3-item Likert-scale to answer the following question: How do you rate this patient’s overall pain relief with the drug? with 3 possible answers: very effective, effective, or ineffective."|12 weeks|The analysis was performed using the full analysis population (All randomized patients who received at least one dose of the assigned study medication and had at least one post Baseline assessment of any functional scale). Last Individual value.||participants|||Number
786231|NCT00839241|Secondary|Interleukin-4||Day 8 postop|||pg/mL||Standard Deviation|Mean
786232|NCT00839241|Secondary|Interleukin-4||Day 5 postop|||pg/mL||Standard Deviation|Mean
786233|NCT00839241|Secondary|Interleukin-4||Baseline|||pg/mL||Standard Deviation|Mean
786234|NCT00839241|Secondary|Interleukin-2||Day 8 postop|||pg/mL||Standard Deviation|Mean
786047|NCT00832416|Secondary|Multiple Dose Effect Using 24-hour VAS Pain Questionnaire|Patients rated their knee pain by marking a 100mm Visual Analogue Scale, ranging from no pain (0mm) to extreme pain (100mm).|12 weeks|The analysis was performed using the full analysis population (All randomized patients who received at least one dose of the assigned study medication and had at least one post Baseline assessment of any functional scale). Missing Values at Last Visit Imputed by Individual Last Post Baseline Value.||mm||Standard Deviation|Mean
786048|NCT00832416|Secondary|Percentage Difference in WOMAC Physical Function Subscale Score From Baseline to Intervening Visits (Visits 2-4)|Percentage of difference in WOMAC Physical Function Subscale score between baseline and intervening visits 2-4. The WOMAC scale is a 24-item questionnaire divided in 3 subscales. The WOMAC Physical Function Subscale comprises 17 questions each rated on a 100mm visual analog scale (VAS) ranging from no pain (0mm) to extreme pain (100mm).|Week 0, week 3, week 6|The analysis was performed using the full analysis population (All randomized patients who received at least one dose of the assigned study medication and had at least one post Baseline assessment of any functional scale). Missing Values at Last Visit Imputed by Individual Last Post Baseline Value.||Percentage difference||Standard Deviation|Mean
786049|NCT00832416|Secondary|Percentage Difference in WOMAC Pain Subscale Score From Baseline to Intervening Visits (Visits 2-4)|Percentage of difference in WOMAC Pain Subscale score between baseline and intervening visits 2-4. The WOMAC scale is a 24-item questionnaire divided in 3 subscales, using a 100mm visual analog scale ranging from no pain (0mm) to extreme pain (100mm). The WOMAC Pain Subscale results from the sum of 5 questions.|Week 0, week 3, week 6|The analysis was performed using the full analysis population (All randomized patients who received at least one dose of the assigned study medication and had at least one post Baseline assessment of any functional scale). Missing Values at Last Visit Imputed by Individual Last Post Baseline Value.||Percentage difference||Standard Deviation|Mean
786050|NCT00832416|Primary|Percentage Difference Between WOMAC Pain Subscale Score From Baseline to the End of the Study (Week 12)|Percentage of difference in WOMAC Pain Subscale score between baseline and week 12. The WOMAC scale is a 24-item questionnaire divided in 3 subscales, using a 100mm visual analog scale ranging from no pain (0mm) to extreme pain (100mm). The WOMAC Pain Subscale results from the sum of 5 questions.|Baseline to week 12|The analysis was performed using the full analysis population (All randomized patients who received at least one dose of the assigned study medication and had at least one post Baseline assessment of any functional scale). Missing Values at Last Visit Imputed by Individual Last Post Baseline Value.||Percentage difference||Standard Deviation|Mean
786051|NCT00832416|Primary|Patient Global Rating of Pain for the Study Period (12 Weeks)|"3-item Likert-scale: How do you rate overall pain relief with the drug? with 3 possible answers: very effective, effective, or ineffective. The average of ratings at visits 2-5 was calculated as median, rounded up to the closest integer."|12 weeks|The analysis was performed using the full analysis population (All randomized patients who received at least one dose of the assigned study medication and had at least one post Baseline assessment of any functional scale). Last Individual value.||participants|||Number
786052|NCT00832455|Other Pre-specified|Pediatric Asthma Caregiver’s Quality of Life Questionnaire (PACQLQ)|"The change in the quality of life of the caregivers of patients treated with montelukast for the control of asthma used in combination with inhaled corticosteroids, using the Pediatric Asthma Caregiver’s Quality of Life Questionnaire (PACQLQ).
PACQLQ score ranges between 1 (severe impairment) and 7 (no impairment) where a higher score indicates better quality of life. An average change in overall score ≥0.7 is considered clinically significant. Changes between visits and baseline are described."|Weeks 4, 8, and 12|420 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. The following results are based on the 411 patients who completed week 4, the 247 who completed week 8, and the 373 patients who completed week 12.||Units on a Scale||Standard Deviation|Mean
786053|NCT00832455|Other Pre-specified|Patient Global Satisfaction|At week 0, 4, 8 and 12, patients were asked to complete a single question describing how satisfied they were regarding their asthma controller medication.|Week 0, 4, 8 and 12|420 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. The following results are based on the 411 patients who completed week 4, the 247 who completed week 8, and the 373 patients who completed week 12.||Participants|||Number
786054|NCT00832455|Other Pre-specified|Physician Global Satisfaction|At week 0, 4, 8 and 12, physicians were asked to complete a single question describing how satisfied they were regarding the asthma controller medication for each of their enrolled patients.|week 0, 4, 8 and 12|420 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. The following results are based on the 411 patients who completed week 4, the 247 who completed week 8, and the 373 patients who completed week 12.||Participants|||Number
786055|NCT00832455|Secondary|Asthma Control Questionnaire (ACQ)|ACQ is a questionnaire consisting of seven 7-point Likert scale questions describing frequency and severity of asthma symptoms. Score ranges between 0 (well-controlled) and 6 (extremely poorly controlled); a score of ≤0.75 indicates well controlled symptoms.|Week 0, 4, and 12|420 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. The following results are based on the 411 patients who completed week 4, the 247 who completed week 8, and the 373 patients who completed week 12.||Participants|||Number
786056|NCT00832455|Primary|Asthma Control Questionnaire (ACQ)|ACQ is a questionnaire consisting of seven 7-point Likert scale questions describing frequency and severity of asthma symptoms. Score ranges between 0 (well-controlled) and 6 (extremely poorly controlled); a score of ≤0.75 indicates well controlled symptoms.|Week 0, 4, and 12|420 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. The following results are based on the 411 patients who completed week 4 and the 373 patients who completed week 12.||Participants|||Number
786059|NCT00832572|Secondary|Response to Thermal and Mechanical Stimuli|The participant response to thermal and mechanical stimuli as measured by the Hargreaves and Von Frey tests|Baseline to Week 6|Study was stopped and no analyses were performed on the secondary outcome measures.|||||
786235|NCT00839241|Secondary|Interleukin-2||Day 5 postop|||pg/mL||Standard Deviation|Mean
786063|NCT00832585|Primary|Change in Eczema Area Severity Index (EASI) Score From Baseline (Week 1) to Week 16.|The Eczema Area Severity Index (EASI) measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) using 0=none, 1=mild, 2=moderate, 3=severe. Head/neck, upper limbs, trunk, lower limbs are rated from 1 to 6 (0=no eruption, 1=1-9%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89%, 6=90-100%). The proportional factor for the head/neck =.01, upper limbs=.02, trunk=.03 and lower limbs=.04. The algorithm for calculating the EASI is the sum of E+I+Ex+L multiplied by the area, multiplied by the proportional factor. The total score is the sum of the four body-region scores, max=72, min=0.|Week 1 to week 16|8 (4 female and 4 male) atopic patients, ranging in age from 24 to 54 yrs of age, were screened for the study. 5 patients were enrolled for 12 wks of treatment, but only 3 completed the study.||Scores on a scale.||Full Range|Median
786064|NCT00832624|Primary|Change From Baseline in HbA1c (Hemoglobin A1c) at Week 18|Glycosylated hemoglobin (HbA1c) was to be measured as the percentage of hemoglobin that has glucose bound to it; however, the study was terminated early therefore no laboratory tests were performed, and no outcome data was collected.|Baseline and Week 18|The study was terminated early and no data were analyzed for this outcome.|||||
786070|NCT00832650|Secondary|Mean Proportion of Bowel Movements With Satisfaction Per Day|The number of stools with satisfaction of “Yes” divided by the total number of stools passed on each notional day. Mean of 3 days.|Day 11 to 13|ITT, all randomized subjects with analyzeable data. Imputation by individual mean for missing data if at least one observation was observed in last 3 days.||mean proportion||Standard Deviation|Mean
786071|NCT00832650|Secondary|Average Score of Ease of Passage During Defecation Per Day|Calculated by averaging the values given for the ease of passage at each visit to the toilet on each notional day. Mean of 3 days. Range of possible scores: 1 (Manual disimpaction) to 7 (Incontinent).|Day 11 to 13|ITT, all randomized subjects with analyzeable data. Imputation by individual mean for missing data if at least one observation was observed in last 3 days.||score on a scale||Standard Deviation|Mean
786072|NCT00832650|Secondary|Mean Score of Stool Consistency Per Day|Calculated by averaging the values of the stool form given at each visit to the toilet on each notional day. Mean of 3 days. Range of possible scores: 1 (hard lumps) to 7 (watery).|Day 11 to 13|ITT, all randomized subjects with analyzeable data. Imputation by individual mean for missing data if at least one observation was observed in last 3 days.||score on a scale||Standard Deviation|Mean
786073|NCT00832650|Secondary|Mean Number of Stools Per Day|Number of stools passed on each notional day where each visit to the toilet counts as one stool (only) unless nothing is passed. Mean of 3 days.|Day 11 to 13|ITT, all randomized subjects with analyzeable data. Imputation by individual mean for missing data if at least one observation was observed in last 3 days.||stools||Standard Deviation|Mean
786074|NCT00832650|Secondary|Time to Gastric Emptying|Ascending colon emptying t½ was estimated by power exponential analysis of the proportionate emptying over time of counts from the colon.|Day 12: 2 hours, 4 hours|ITT included all randomized subjects. Imputation by overall mean for missing data.||minutes||Standard Deviation|Mean
786075|NCT00832650|Secondary|Colonic Filling at 6 Hours|A surrogate marker of small bowel transit time.|Day 12|ITT included all randomized subjects. Imputation by overall mean for missing data.||percentage||Standard Deviation|Mean
786236|NCT00839241|Secondary|Interleukin-2||Baseline|||pg/mL||Standard Deviation|Mean
786237|NCT00839241|Secondary|Interferon Gamma||Day 8 postop|||pg/mL||Standard Deviation|Mean
786238|NCT00839241|Secondary|Interferon Gamma||Day 5 postop|||pg/mL||Standard Deviation|Mean
786239|NCT00839241|Secondary|Interferon Gamma||Baseline|||pg/mL||Standard Deviation|Mean
786076|NCT00832650|Secondary|Colonic Transit at 48 Hours|Colonic transit: Geometric centre at 48 hours (GC48) was estimated using geometric mean of counts in ascending (AC), transverse (TC), descending (DC) and rectosigmoid (RS) colon and stool (weighted by factors of 1 to 5 respectively). To calculate the geometric centre, the proportion of colonic counts in each colonic region was multiplied by its weighing factor: (% AC *1 + % TC *2 + % DC *3 + % RS *4 + % stool * 5 ) divided by 100.|Day 14 (Day 12 48 hours post-meal)|ITT included all randomized subjects. Imputation by overall mean for missing data.||counts||Standard Deviation|Mean
786077|NCT00832650|Secondary|Proximal Colonic Emptying Time|Estimated by power exponential analysis of the proportionate emptying over time of counts from the colon.|Day 12 to 14|ITT included all randomized subjects. Imputation by overall mean for missing data.||hours||Standard Deviation|Mean
786078|NCT00832650|Primary|Colonic Transit at 24 Hours|Colonic transit: Geometric centre at 24 hours (GC24) was estimated using geometric mean of counts in ascending (AC), transverse (TC), descending (DC) and rectosigmoid (RS) colon and stool (weighted by factors of 1 to 5 respectively). To calculate the geometric centre, the proportion of colonic counts in each colonic region was multiplied by its weighing factor: (% AC *1 + % TC *2 + % DC *3 + % RS *4 + % stool * 5 ) divided by 100.|Day 13 (Day 12 24 hours post-meal)|Intent to treat (ITT) included all randomized subjects. Imputation by overall mean for missing data.||counts||Standard Deviation|Mean
786079|NCT00832819|Secondary|To Evaluate the Safety and Tolerability of E7080 in Combination With Carboplatin and Paclitaxel.|Refer safety section for safety analysis|Throughout the study until 30 days after last dose||||||
786080|NCT00832819|Secondary|Pharmacokinetics and Pharmacodynamics of E7080 in Combination With Carboplatin and Paclitaxel.||At various time points until Day 22 of Cycle 1||||||
786081|NCT00832819|Primary|Maximum Tolerated Dose (MTD)|Tolerability was confirmed by the frequency of occurrence of Dose Limiting Toxicities (DLTs) observed by the end of Cycle 1 in 6 participants.|7 days during the run-in period (Cycle 0) and 3 weeks (21 days) from Cycle 1|DLTs were analyzed on the Safety Analysis Set; however subjects with 75% or less treatment compliance for E7080 in Cycle 1 or those who discontinued the study and had no confirmed data on tolerability up to Cycle 1 Day 22 were excluded from this analysis.||mg BID|||Number
786082|NCT00832819|Secondary|Anti-tumor Effect of E7080 in Combination With Carboplatin and Paclitaxel.||At Screening, on Day 22 of every even cycle, and at discontinuation||||||
786083|NCT00832871|Other Pre-specified|Overall Survival|The time from patient entry into the protocol to death by any cause.|5 years|||Months||Standard Deviation|Median
786084|NCT00832871|Secondary|Toxicity Associated With Adrenal Insufficiency|Toxicity will be evaluated per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Frequency and severity of adverse events will be tabulated using counts the following events of interest, which are related to possible adrenal insufficiency: nausea, vomiting, lethargy, dizziness, fatigue, anorexia, and skin rash. Any grade of these events that are self-reported by patients as well as events identified by physician assessment (e.g. physical exam) will be included.|Up to 8 weeks after the end of study treatment|All patients received at least one dose of study medication and are included in this analysis.||percentage of participants|||Number
786085|NCT00832871|Primary|Duration of Response|The time from the date of response (not the beginning of treatment unless there is stable disease) to disease progression. Response and progression are evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|5 years|Only one patient achieved stable disease. This patient's duration of response could therefore be reported. The other three patients progressed on treatment.||days||Full Range|Median
786086|NCT00832975|Secondary|Cardiovascular Mortality Hospitalization Rate Due to Cardiovascular Reasons or Heart Failure||24 months|||Patients|||Number
786087|NCT00832975|Primary|Slow Ventricular Tachycardia Episodes Devices Detected (Between 120-150 Bpm and > 30sec) Atrial Fibrillation (AF) Episodes Devices Detected (> 30 Sec)|Slow Ventricular Tachycardia episodes will be considered as a tachycardia episodes detected by the device between 120-150 bpm and with more than 30sec of duration AF Episodes will be considered only when their duration is >30sec|24 months|157 patients were analyzed: 118 completed 2 years of Follow Up (FU) and 39 patients were terminated before completing it||Episodes|||Number
786088|NCT00833027|Secondary|Change From Baseline in HbA1c at Week 12|HbA1c is measured as percent. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the Week 0 HbA1c percent|Baseline and Week 12|Includes all patients who received at least one dose of study medication and have a Week 12 measure.||Percent||Standard Deviation|Mean
786089|NCT00833027|Primary|Change From Baseline in HbA1c at Week 24|HbA1c is measured as percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent|Baseline and Week 24|Includes all patients who received at least one dose of study medication and have a Week 24 measure.||Percent||Standard Deviation|Mean
786090|NCT00833040|Primary|Time-weighted SPID30|time-weighted SPID30 is the sum of the pain intensity difference (PID) over the 30 minute time period. A pain intensity score of 0 (no pain) to 10 (worse possible pain) is recorded at pre-dose, 10, 15, 30, 45, and 60 minutes post-dose. The pain score at each assessment time through 30 minutes is subtracted from the baseline pain score to provide the total sum score or SPID30. A higher SPID30 is better and indicates a reduction in pain intensity compared to the baseline score.|30 minutes after dosing|Intent to treat population defined as all patients who took at least one dose of study drug||units on a scale||Standard Error|Least Squares Mean
786130|NCT00833482|Primary|Cmax and Cmin of Voriconazole, Administered With and Without Atazanavir/Ritonavir, in EM Participants|Cmax=maximum observed plasma concentration; Cmin=minimum observed plasma concentration; EM=extensive metabolizers, or participants with functional CYP2C19 alleles.|Predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdoseDays 3 and 30 of a 30-day cycle|All participants who were healthy, who had functional CYP2C19 alleles, who received any study drug, and who had concentration-time data available.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
786091|NCT00833053|Secondary|Euro-Qol 5 Dimension (EQ-5D) Change From Baseline at Week 28|The EQ-5D is a descriptive system comprised of the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Participants are asked to indicate his/her health state by selecting the most appropriate statement in each of the 5 dimensions. This selection results in a 1-digit number expressing the level selected for that dimension. The digits for 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1-5 have no arithmetic properties and should not be used as a cardinal score.|Baseline, Week 28|The study was terminated early with only 15% subjects of the original planned size. Accordingly, secondary efficacy analyses were cancelled due to such a small subject population.|||||
786092|NCT00833053|Secondary|Dermatology Life Quality Index (DLQI) at Week 28|The DLQI is a 10-item questionnaire. Scores range from 0-10 with 0 indicating high quality of life and 10 indicating poor quality of life.|Week 28|The study was terminated early with only 15% subjects of the original planned size. Accordingly, secondary efficacy analyses were cancelled due to such a small subject population.|||||
786093|NCT00833053|Secondary|Change From Baseline in Mean Participant Raw PASI Scores at Week 28|The PASI score is a measure of the average redness, thickness, and scaliness of psoriasis lesions. Each lesion is graded on a 0–4 scale, weighted by the area of involvement, with increasing scores indicating increasing severity.|Baseline, Week 28|The study was terminated early with only 15% subjects of the original planned size. Accordingly, secondary efficacy analyses were cancelled due to such a small subject population.|||||
786094|NCT00833053|Secondary|Number of Participants With A PASI-100 Response at Week 28|The PASI score is a measure of the average redness, thickness, and scaliness of psoriasis lesions. Each lesion is graded on a 0–4 scale, weighted by the area of involvement, with increasing scores indicating increasing severity. The PASI-100 response indicates the number of participants achieving a 100% reduction compared to baseline in PASI score.|Baseline, Week 28|The study was terminated early with only 15% subjects of the original planned size. Accordingly, secondary efficacy analyses were cancelled due to such a small subject population.|||||
786095|NCT00833053|Secondary|Number of Participants With A PASI-90 Response at Week 28|The PASI score is a measure of the average redness, thickness, and scaliness of psoriasis lesions. Each lesion is graded on a 0–4 scale, weighted by the area of involvement, with increasing scores indicating increasing severity. The PASI-90 response indicates the number of participants achieving a 90% reduction compared to baseline in PASI score.|Baseline, Week 28|The study was terminated early with only 15% subjects of the original planned size. Accordingly, secondary efficacy analyses were cancelled due to such a small subject population.|||||
786096|NCT00833053|Secondary|Number of Participants With A PASI-50 Response at Week 28|The PASI score is a measure of the average redness, thickness, and scaliness of psoriasis lesions. Each lesion is graded on a 0–4 scale, weighted by the area of involvement, with increasing scores indicating increasing severity.The PASI-50 response indicates the number of participants achieving a 50% reduction compared to baseline in PASI score.|Baseline, Week 28|The study was terminated early with only 15% subjects of the original planned size. Accordingly, secondary efficacy analyses were cancelled due to such a small subject population.|||||
786097|NCT00833053|Primary|Number of Participants With A Psoriasis Area and Sensitivity Index (PASI)-75 Response at Week 28|The Psoriasis Area and Sensitivity Index (PASI) is a measure of the average redness, thickness, and scaliness of psoriasis lesions. Each lesion is graded on a 0–4 scale, weighted by the area of involvement, with increasing scores indicating increasing severity. The PASI-75 response indicates the number of participants achieving a 75% reduction in PASI score compared to baseline.|Baseline, Week 28|||Participants|||Number
786098|NCT00833092|Primary|Global Pittsburgh Sleep Quality Index|Improvement in the Pittsburgh Global Sleep Quality Index (PGQI). The index is based on a score of 0 to 21, the lower the score on the index the better the subject perceives their sleep.|9 weeks|Data from 4 participants (3 on sugar pill, 1 on magnesium) were omitted from statistical analysis because of protocol violations discovered near end of study.||score on a scale||Standard Error|Mean
786099|NCT00833248|Secondary|Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables|The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) levels of safety laboratory variables. Only the laboratory variables that had at least one percentage of participants in either group with abnormal value are presented, more variables were included in the study.|Baseline to 12 weeks of treatment|Safety analysis set.||participants|||Number
786100|NCT00833248|Secondary|Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight|This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value.|Baseline to 12 weeks of treatment|Safety analysis set.||participants|||Number
786101|NCT00833248|Secondary|Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit|The IPSS questionnaire included an additional single question to assess the participant's QoL in relation to his urinary symptoms. The question was: 'If you were to spend the rest of your life with your urinary condition the way it is now, how would you feel about that?' The possible answers to this question ranged from 'delighted' (a score of '0') to 'terrible' (a score of '6').|After treatment of 4, 8, and 12 weeks compared to Baseline|FAS, OC.||scores on a scale||Standard Deviation|Mean
786102|NCT00833248|Secondary|Change From Baseline in Serum Oestradiol Levels During the Study||After treatment of 4, 8, and 12 weeks compared to Baseline|FAS, OC.||nanogram per deciliter||Full Range|Median
786103|NCT00833248|Secondary|Change From Baseline in Serum Prostate-Specific Antigen (PSA) Levels During the Study||After treatment of 4, 8, and 12 weeks compared to Baseline|FAS, OC.||nanograms per milliliter||Full Range|Median
786104|NCT00833248|Secondary|Change From Baseline in Serum Testosterone Levels During the Study||After treatment of 4, 8, and 12 weeks compared to Baseline|FAS, OC.||nanograms per milliliter||Full Range|Median
786131|NCT00833482|Primary|Tmax of Voriconazole, Administered With and Without Atazanavir/Ritonavir, in EM Participants|Tmax=time to maximum concentration; EM=extensive metabolizers, or participants with functional CYP2C19 alleles.|Predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdoseDays 3 and 30 of a 30-day cycle|All participants who were healthy, who had functional CYP2C19 alleles, who received any study drug, and who had concentration-time data available.||Hours||Full Range|Median
786105|NCT00833248|Secondary|Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 4, 8, and 12|The IPSS is a tool commonly used to assess the severity of lower urinary tract symptoms (LUTS), and to monitor the progress of the disease once treatment has been initiated. The participant completes a questionnaire containing 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5. The total score is then classified according to the following scale: 0 to 7 = mildly symptomatic; 8 to 19 = moderately symptomatic; and 20 to 35 = severely symptomatic.|After treatment of 4, 8, and 12 weeks compared to Baseline|FAS, OC.||scores on a scale||Standard Deviation|Mean
786106|NCT00833248|Primary|Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Per Protocol Analysis Set)|TRUS is a method of measuring the size of the prostate.|After treatment of 12 weeks compared to Baseline|FAS, OC.||milliliter||Standard Deviation|Mean
786107|NCT00833248|Primary|Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Full Analysis Set)|TRUS is a method of measuring the size of the prostate.|After treatment of 12 weeks compared to Baseline|FAS, Observed Case (OC) i.e. only participants with a reported value were included in the analysis.||milliliter||Standard Deviation|Mean
786108|NCT00833365|Secondary|Plasma Catecholamines, Glucose, and Lactate Levels 1 and 6 Hours After Ibuprofen Administration||1 and 6 hours|Due to early termination of the study, labs were not analyzed.|||||
786109|NCT00833365|Primary|Number of PDA Closures Related to Treatment With Ibuprofen|Closure of the Patent Ductus in response to early or late treatment of ibuprofen was evaluated by echocardiogram. There is only one event (closure) possible per participant.|Within 48 hrs of ibuprofen round|Premature infants born at 23+3 weeks to 29+4 weeks with positive patent ductus arteriosus on cardiac echogram were randomized to early or late treatment with ibuprofen. 2 babies which had been originally randomized to the late treatment arm never got ibuprofen and are not included in analysis.||closures related to treatment|||Number
786110|NCT00833417|Secondary|Percentage of Patients With Absence of Residual Basal Cell Carcinoma (BCC) in Patients With Locally Advanced BCC|In patients with locally advanced BCC, the histopathological effect of vismodegib was determined in tissue biopsies obtained at baseline and following vismodegib treatment. Reported are the percentage of patients with pathology confirmed BCC in baseline biopsy who had an absence of residual BCC post-baseline as assessed by an independent pathological review.|From baseline through end of the study, up to 90 weeks|Efficacy-evaluable population: All treated patients for whom the independent pathologist’s interpretation of archival tissue or baseline biopsies was consistent with basal cell carcinoma. Only locally advanced BCC patients with available post-baseline biopsy assessed by an independent pathologist were included in the analysis.||Percentage of participants|||Number
786111|NCT00833417|Secondary|Change From Baseline in Short Form 36 (SF-36) Health Survey Scores|The SF-36 Health Survey (Version 2) uses patient-reported symptoms on 8 subscales to assess health-related quality of life (HRQoL). The Physical Component Summary (PCS) score summarizes the subscales Physical Functioning, Role−Physical, Bodily Pain, and General Health. The Mental Component Summary (MCS) score summarizes the subscales Vitality, Social Functioning, Role−Emotional, and Mental Health. Each score was scaled from 0 to 100. A positive change score indicates better HRQoL.|Baseline, Week 12, Week 24, and at the end of the study or early termination visit, up to 90 weeks|Efficacy-evaluable population: All treated patients for whom the independent pathologist’s interpretation of archival tissue or baseline biopsies was consistent with basal cell carcinoma.||Units on a scale||95% Confidence Interval|Mean
786112|NCT00833417|Secondary|Overall Survival|Overall survival was defined as the time from the initial dose of vismodegib until death from any cause.|From study initiation (enrollment of first patient) through 9 months following the first treatment of the last enrolled patient (clinical cutoff date of 26 November 2010), up to 90 weeks|Efficacy-evaluable population: All treated patients for whom the independent pathologist’s interpretation of archival tissue or baseline biopsies was consistent with basal cell carcinoma.||Months||95% Confidence Interval|Median
786113|NCT00833417|Secondary|Progression-free Survival (PFS) Determined by the Independent Review Facility|PFS was defined as the time from start of treatment to the earliest documented disease progression (PD) or death. Metastatic BCC - PD: ≥ 20% increased sum of the longest diameter (SLD) of targets from nadir, or 1 or more new lesions. Locally advanced BCC - PD: any of: (1) ≥ 20% increased SLD from nadir (radiography or externally visible dimension); (2) new ulceration; (3) new lesions (radiography or physical exam); (4) progression of non-target lesions by radiography.|From study initiation (enrollment of first patient) through 9 months following the first treatment of the last enrolled patient (clinical cutoff date of 26 November 2010), up to 90 weeks|Efficacy-evaluable population: All treated patients for whom the independent pathologist’s interpretation of archival tissue or baseline biopsies was consistent with basal cell carcinoma.||Months||95% Confidence Interval|Median
786114|NCT00833417|Secondary|Duration of Objective Response (OR) Determined by the Independent Review Facility|Duration of OR was defined as the time from the initial CR or PR to the earliest documented disease progression (PD) or death. Metastatic BCC - PD: ≥ 20% increased sum of the longest diameter (SLD) of targets from nadir, or 1 or more new lesions. Locally advanced BCC - PD: any of: (1) ≥ 20% increased SLD from nadir (radiography or externally visible dimension); (2) new ulceration; (3) new lesions (radiography or physical exam); (4) progression of non-target lesions by radiography.|From study initiation (enrollment of first patient) through 9 months following the first treatment of the last enrolled patient (clinical cutoff date of 26 November 2010), up to 90 weeks|Efficacy-evaluable population: All treated patients for whom the independent pathologist’s interpretation of archival tissue or baseline biopsies was consistent with basal cell carcinoma.||Months||95% Confidence Interval|Median
786132|NCT00833482|Secondary|Tmax of Ritonavir, Administered As Atazanavir/Ritonavir With and Without Voriconazole, in EM Participants|Tmax=time to maximum concentration; EM=extensive metabolizers, or participants with functional CYP2C19 alleles.|Predose and at 1, 2, 3, 4, 5, 7, 9,13, and 24 hours postdose on Days 20 and 30 of a 30-day cycle|All participants who were healthy, who had functional CYP2C19 alleles, who received any study drug, and who had concentration-time data available.||Hours||Full Range|Median
786240|NCT00839241|Primary|Natural Killer Cells (Proportion of Lymphocytes, Measured With Flow Cytometry)||Day 8 postop|||Percent||Standard Deviation|Mean
786241|NCT00839241|Primary|Natural Killer Cells (Proportion of Lymphocytes, Measured With Flow Cytometry)||Day 5 postop|||Percent||Standard Deviation|Mean
786115|NCT00833417|Primary|Objective Response (OR) Determined by the Independent Review Facility|OR=complete (CR) or partial response (PR). Metastatic-CR:Disappearance of all targets. PR:≥30% decreased sum of longest diameter (SLD) of targets compared to baseline (B). Locally advanced-Response=No progressive disease (PD) and ≥30% decreased SLD from baseline (radiography [R]) or ≥30% decreased SLD from B (externally visible dimension [EVD]) or completely resolved ulceration. CR:Response with no residual BCC on tumor biopsy (otherwise response was PR). PD:Any of ≥20% increased SLD from nadir (R or EVD), new ulceration, new lesions (R or physical exam) or non-target lesion progression by R.|From study initiation (enrollment of first patient) through 9 months following the first treatment of the last enrolled patient (clinical cutoff date of 26 November 2010), up to 90 weeks|Efficacy-evaluable population: All treated patients for whom the independent pathologist’s interpretation of archival tissue or baseline biopsies was consistent with basal cell carcinoma.||Percentage of participants||95% Confidence Interval|Number
786116|NCT00833443|Post-Hoc|End of Treatment Methamphetamine Abstinence||12 weeks|||participants|||Number
786117|NCT00833443|Secondary|Treatment Retention||12 weeks|||days||Standard Deviation|Mean
786118|NCT00833443|Primary|End of Treatment Methamphetamine Abstinence|Methamphetamine abstinence confirmed via urine drug screens during the final two weeks of treatment (weeks 11 and 12)|12 weeks|||participants|||Number
786119|NCT00833443|Primary|Treatment Effectiveness Score|The mean number of methamphetamine-free urine drug screens provided by participants in each group (range 0-36)|12 weeks|||urine drug screens||Standard Deviation|Mean
786120|NCT00833469|Secondary|Change in Beck Anxiety Inventory (BAI)|Beck Anxiety Inventory (BAI): The BAI is a 21-item self-report questionnaire measuring typical symptoms of anxiety during the past week (range 0-63, higher score indicates greater anxiety).|8 weeks|Of 7 subjects consented, 5 were eligible after V1. Before V2, 1 subject dropped and 1 was LTF. Three subjects completed the study.||units on a scale||Standard Deviation|Mean
786121|NCT00833469|Secondary|Change in Edinburgh Postnatal Depression Scale (EPDS)|The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report used to measure postpartum depression (range 0-30, higher score indicates greater symptom burden). A score of >9 is indicative of perinatal major depression.|8 weeks|Of 7 subjects consented, 5 were eligible after V1. Before V2, 1 subject dropped and 1 was LTF. Three subjects completed the study.||units on a scale||Standard Deviation|Mean
786122|NCT00833469|Primary|Change in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS)|The Montgomery-Åsberg Depression Rating Scale is a widely used 10-item clinician-rated scale that describes the severity of depressive symptoms (range 0-60, higher score indicates greater symptom burden).|8 weeks|Of 7 subjects consented, 5 were eligible after V1. Before V2, 1 subject dropped and 1 was LTF. Three subjects completed the study.||units on a scale||Standard Deviation|Mean
786123|NCT00833482|Secondary|Number of Participants With Abnormalities in Vital Signs||Within 21 days of Day 1 and on Days -1, 1, 3, 11, 21, and 31 (at discharge)|All participants who received study drug.||Participants|||Number
786124|NCT00833482|Secondary|Number of Participants With Investigator-identified Abnormalities in Electrocardiogram Results Not Present Prior to Administration of Study Drug and Considered Not Relevant and Not AEs by Investigator|volt=voltage; LVH=left ventricular hypertrophy|Within 21 days of Day 1 and on Days -1, 21, and 31 (at discharge)|All participants who received study drug.||Participants|||Number
786125|NCT00833482|Secondary|Number of Participants With Marked Abnormalities in Hematology Laboratory Test and Urinalysis Results|LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Safety criteria: Neutrophils + bands: If <.85*LLN or >1.15*ULN or ULN or if preRX<LLN, use <0.85*preRX or >ULN; if preRX>ULN, use >1.15*preRX or <LLN. Lymphocytes, relative: If <0.85*LLN or >1.15*ULN, or if preRX <LLN, use <0.85*preRX or >ULN; if preRX >ULN, use >1.15*preRX or <LLN. Blood, urine: If >= 2+, or if preRX >=1+, use >=2*preRX. White blood cells, urine: If >=2+, or if preRX >=2+, use >=4+. Red blood cells, urine: If >=2+ or if preRX >=2+, use >=4+. Not all categories were evaluated for each arm.|Within 21 days of Day 1 and on Days 3, 10, 20, 26, and 31 (at discharge)|All participants who received study drug.||Participants|||Number
786126|NCT00833482|Secondary|Number of Participants With Marked Abnormalities in Serum Chemistry Test Results|LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Safety criteria: AST and ALT: If >1.25*ULN, or if preRX>ULN, use >1.25*preRX. Total and direct bilirubin: If >1.1*ULN or if preRX>ULN, use >1.25*preRX. Creatinine: If >1.33*preRX. Serum glucose, fasting: If preRX<LLN, use <.8*preRX or >ULN; if preRX>ULN, use >2*preRX or <LLN. Creatinine kinase: If >1.5*ULN or preRX>ULN, use >1.5*or preRX. Lactose dehydrogenase: If >1.25*ULN or preRX>ULN, use >1.5*preRX.|Within 21 days of Day 1 and on Days 3, 10, 20, 26, and 31 (at discharge)|All participants who received study drug.||Participants|||Number
786127|NCT00833482|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Any AE|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|Days 1 to 31 (discharge), continuously|All participants who received study drug.||Participants|||Number
786128|NCT00833482|Secondary|AUC(TAU) of Ritonavir, Administered As Atazanavir/Ritonavir With and Without Voriconazole, in EM Participants|AUC(TAU)=area under the plasma concentration-time curve in 1 dosing interval; EM=extensive metabolizers, or participants with functional CYP2C19 alleles.|Predose and at 1, 2, 3, 4, 5, 7, 9,13, and 24 hours postdose on Days 20 and 30 of a 30-day cycle|All participants who were healthy, who had functional CYP2C19 alleles, who received any study drug, and who had concentration-time data available.||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
786129|NCT00833482|Primary|AUC(TAU)of Voriconazole, Administered With and Without Atazanavir/Ritonavir, in EM Participants|AUC(TAU)=area under the plasma concentration-time curve in 1 dosing interval; EM=extensive metabolizers, or participants with functional CYP2C19 alleles.|Predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdoseDays 3 and 30 of a 30-day cycle|All participants who were healthy, who had functional CYP2C19 alleles, who received any study drug, and who had concentration-time data available.||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
786166|NCT00833690|Secondary|Change in Serum Urate|Change from an Average of Baseline and Screening Visits|Visit 12 from Baseline (i.e., between -45 days and +24 months)|||mg/dL||Standard Deviation|Mean
786133|NCT00833482|Secondary|Cmax and Cmin of Ritonavir, Administered As Atazanavir/Ritonavir With and Without Voriconazole, in EM Participants|Cmax=maximum observed plasma concentration; Cmin=minimum observed plasma concentration; EM=extensive metabolizers, or participants with functional CYP2C19 alleles.|Predose and at 1, 2, 3, 4, 5, 7, 9,13, and 24 hours postdose on Days 20 and 30 of a 30-day cycle|All participants who were healthy, who had functional CYP2C19 alleles, who received any study drug, and who had concentration-time data available.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
786134|NCT00833482|Primary|Area Under the Plasma Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] of Atazanavir Administered as Atazanavir/Ritonavir With and Without Voriconazole, in EM Participants|EM=extensive metabolizers, or participants with functional CYP2C19 alleles.|Predose and at 1, 2, 3, 4, 5, 7, 9,13, and 24 hours postdose on Days 20 and 30 of a 30-day cycle|All participants who were healthy, who had functional CYP2C19 alleles, who received any study drug, and who had concentration-time data available.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
786135|NCT00833482|Primary|Time to Maximum Concentration (Tmax) of Atazanavir, Administered as Atazanavir/Ritonavir With and Without Voriconazole, in EM Participants|EM=extensive metabolizers, or participants with functional CYP2C19 alleles.|Predose and at 1, 2, 3, 4, 5, 7, 9,13, and 24 hours postdose on Days 20 and 30 of a 30-day cycle|All participants who were healthy, who had functional CYP2C19 alleles, who received any study drug, and who had concentration-time data available.||Hours||Full Range|Median
786136|NCT00833482|Primary|Maximum Observed Plasma Concentration (Cmax) and Minimum Observed Plasma Concentration (Cmin) of Atazanavir, Administered as Atazanavir/Ritonavir With and Without Voriconazole, in Participants Who Are Extensive Metabolizers (EM)|EM participants are those with functional CYP2C19 alleles.|Predose and at 1, 2, 3, 4, 5, 7, 9,13, and 24 hours postdose on Days 20 and 30 of a 30-day cycle|All participants who were healthy, who had functional CYP2C19 alleles, who received any study drug, and who had concentration-time data available.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
786137|NCT00833521|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
786138|NCT00833521|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
786139|NCT00833521|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
786140|NCT00833547|Primary|Sleep Spindle Density During Stage 2 Sleep as Measured by Polysomnography|2 baseline nights (Days 1 &2); 2 experimental nights (Days 3 &4)|during two nights in an inpatient Clinical Research Center|||spindles per minute during Stage 2 sleep||Standard Deviation|Mean
786141|NCT00833547|Primary|Overnight Change on Finger Tapping Task|"The finger tapping task involves pressing four numerically labeled keys on a standard computer keyboard with the fingers of the left hand, repeating a five element sequence (4-1-3-2-4) as quickly and accurately as possible for 30s. During both training and test sessions, participants alternated tapping and resting for 30s for a total of 12 tapping trials. The measure was the number of correct sequences per trial. Overnight change was the percent change in correct sequences from the last three training trials to the first three test trials the following morning."|Train on Day 3 and Test on Day 4 of study (experimental nights)|||percent change||Standard Deviation|Mean
786142|NCT00833560|Secondary|Percentage of Participants With Complete Response + Partial Response in Relation to Cytogenetic Subgroups (Per-protocol Set)|Response rate was defined as the percentage of participants with response of combined CR+PR according to the EBMT criteria. As per the EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein and no increase in size or number of lytic bone lesions; PR is defined as not all CR criteria and 50 percentage or more reduction in serum monoclonal paraprotein. Percentage of participants with complete or partial response that carried the indicated cytogenetic marker is reported. Same participant could count in more than one category due to multiple responses possible.|Up to Day 63|"Per-protocol analysis set. N (number of participants analyzed) signifies participants with complete or partial response. n signifies number of participants who were evaluable for each specified category (participants that carried the indicated cytogenetic marker)."||Percentage of participants|||Number
786143|NCT00833560|Secondary|Percentage of Participants With Complete Response + Partial Response in Relation to Cytogenetic Subgroups (Efficacy Set)|Response rate was defined as the percentage of participants with response of combined CR+PR according to the EBMT criteria. As per the EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein and no increase in size or number of lytic bone lesions; PR is defined as not all CR criteria and 50 percentage or more reduction in serum monoclonal paraprotein. Percentage of participants with complete or partial response that carried the indicated cytogenetic marker is reported. Same participant could count in more than one category due to multiple responses possible|Up to Day 63|"Efficacy analysis set. N (number of participants analyzed) signifies participants with complete or partial response. n signifies number of participants who were evaluable for each specified category (participants that carried the indicated cytogenetic marker)."||Percentage of participants|||Number
786144|NCT00833560|Secondary|Participants With Complete Response (CR) + Partial Response (PR) (Per-protocol Analysis Set)|CR and PR are defined by the local investigator according to the current European Group for Blood and Marrow Transplantation (EBMT) criteria. According to EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein + no increase in size or number of lytic bone lesions; and PR is defined as not all CR criteria + 50 percentage or more reduction in serum monoclonal paraprotein.|Up to Day 63|Per-protocol analysis set: It includes the participants who completed the entire clinical study without major protocol violations.||Participants|||Number
786167|NCT00833690|Secondary|Change in Serum Urate|Change from an Average of Baseline and Screening Visits|Visit 11 from Baseline (i.e., between -45 days and +21 months)|||mg/dL||Standard Deviation|Mean
786168|NCT00833690|Secondary|Change in Serum Urate|Change from an Average of Baseline and Screening Visits|Visit 10 from Baseline (i.e., between -45 days and +18 months)|||mg/dL||Standard Deviation|Mean
786242|NCT00839241|Primary|Natural Killer Cells (Proportion of Lymphocytes, Measured With Flow Cytometry)||Baseline|||Percent||Standard Deviation|Mean
786145|NCT00833560|Primary|Participants With Complete Response (CR) + Partial Response (PR) (Efficacy Set)|CR and PR are defined by the local investigator according to the current European Group for Blood and Marrow Transplantation (EBMT) criteria. According to EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein + no increase in size or number of lytic bone lesions; and PR is defined as not all CR criteria + 50 percentage or more reduction in serum monoclonal paraprotein.|Up to Day 63|Efficacy analysis set: Participants of the safety analysis set (who received bortezomib at least once independently of accordance to the protocol) who had an evaluable investigator based assessment of success of therapy at the end of study visit (ie, assessment by local investigator as CR, PR, minimal response, stable disease, progressive disease).||Participants|||Number
786146|NCT00833586|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Terbinafine in Plasma|Bioequivalence based on AUC0-t|Blood samples collected over 144 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
786147|NCT00833586|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Terbinafine in Plasma|Bioequivalence based on AUC0-inf|Blood samples collected over 144 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
786148|NCT00833586|Primary|Cmax - Maximum Observed Concentration - Terbinafine in Plasma|Bioequivalence based on Cmax|Blood samples collected over 144 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
786149|NCT00833638|Secondary|Sexual Encounter Profile Diary Question 3, Percentages of Yes Responses During the Double-blind Period and the Open-label Period for Participants Who Didn't Respond to Tadalafil 2.5 mg During Double-blind Period|"Assessed were percentages of successful intercourse attempts relative to the total number of intercourse attempts in both treatment periods. A successful attempt was defined by a yes response to the sexual encounter profile diary question #3: Did your erection last long enough for you to have successful intercourse?"|14 days double-blind and 14 days open-label|Modified intent-to-treat population consisting of all subjects who received tadalafil 2.5 mg in the double-blind study period and did not respond to treatment in that treatment period, who have at least 1 baseline observation and who took at least 1 dose of tadalafil 5 mg in the open-label period followed by at least 1 intercourse attempt.||percentage successful attempts||Standard Deviation|Mean
786150|NCT00833638|Secondary|Sexual Encounter Profile Diary Question 3, Percentages of Yes Responses in the Double-blind Period and the Open-label Period for Participants Who Were Assigned to Tadalafil 5 mg in the Double-blind Treatment Period|"Assessed were percentages of successful intercourse attempts relative to the total number of intercourse attempts over the 14-day open-label treatment period compared with the 14-day double-blind treatment period by dose group during the double-blind treatment period. A successful attempt was defined by a yes response to the sexual encounter profile diary question #3: Did your erection last long enough for you to have successful intercourse?"|14-day double-blind and 14-day open-label|Modified intent-to-treat population consisting of all subjects who have at least 1 baseline observation, who took tadalafil 5 mg during the double-blind treatment period, and who took at least 1 dose of tadalafil 5 mg followed by at least 1 intercourse attempt during the open-label period.||percentage successful attempts||Standard Deviation|Mean
786151|NCT00833638|Secondary|Sexual Encounter Profile Diary Question 3, Percentages of Yes Responses in the Double-blind Period and the Open-label Period for Participants Who Were Assigned to Tadalafil 2.5 mg in the Double-blind Treatment Period|"Assessed were percentages of successful intercourse attempts relative to the total number of intercourse attempts over the 14-day open-label treatment period compared with the 14-day double-blind treatment period by dose group during the double-blind treatment period. A successful attempt was defined by a yes response to the sexual encounter profile diary question #3: Did your erection last long enough for you to have successful intercourse?"|14-day double-blind and 14-day open-label|Modified intent-to-treat population consisting of all subjects who have at least 1 baseline observation and who took at least 1 dose of study drug followed by at least 1 intercourse attempt, and who recorded SEP diary data for it within the first 4 days of therapy following randomization.||percentage successful attempts||Standard Deviation|Mean
786152|NCT00833638|Secondary|Sexual Encounter Profile Diary Question 3, Percentages of Yes Responses During the Double-blind and Open-label Periods for Participants Who Were Assigned to Placebo in the Double-blind Treatment Period|"Assessed were percentages of successful intercourse attempts relative to the total number of intercourse attempts over the 14-day open-label treatment period compared with the 14-day double-blind treatment period by dose group during the double-blind treatment period. A successful attempt was defined by a yes response to the sexual encounter profile diary question #3: Did your erection last long enough for you to have successful intercourse?"|14 days double-blind and 14 days open-label|Modified intent-to-treat population consisting of all subjects who have at least 1 baseline observation and who took at least 1 dose of study drug followed by at least 1 intercourse attempt, and who recorded SEP diary data for it within the first 4 days of therapy following randomization.||percentage successful attempts||Standard Deviation|Mean
786153|NCT00833638|Secondary|Sexual Encounter Profile Diary Question 3, Daily Cumulative Percentage of Successful Intercourse Attempts|"Assessed was the cumulative precentage of successful intercourse attempts (successful attempts relative to the total number of intercourse attempts) over the 14-day double-blind treatment period. A successful attempt was defined by a yes response to the sexual encounter profile diary question #3: Did your erection last long enough for you to have successful intercourse? Data are presented as the proportion of intercourse attempts for which participants answered yes relative to the total number of intercourse attempts. Total number of attempts = TNA."|14 days during double-blind period|Modified intent-to-treat population consisting of all subjects who have at least 1 baseline observation and who took at least 1 dose of study drug followed by at least 1 intercourse attempt, and who recorded SEP diary data for it within the first 4 days of therapy following randomization.||percentage of total number of attempts|||Number
786169|NCT00833690|Secondary|Change in Serum Urate|Change from an Average of Baseline and Screening Visits|Visit 09 from Baseline (i.e., between -45 days and +15 months)|||mg/dL||Standard Deviation|Mean
786170|NCT00833690|Secondary|Change in Serum Urate|Change from an Average of Baseline and Screening Visits|Visit 08 from Baseline (i.e., between -45 days and +12 months)|||mg/dL||Standard Deviation|Mean
786154|NCT00833638|Secondary|Sexual Encounter Profile Diary Question 3, the Overall Distribution of Time to Onset by Yes Responses|"Assessed was the median time to onset of efficacy (day when 50% of participants have had at least 1 successful intercourse attempt) within the first 4 days of therapy based on a yes response to the sexual encounter profile diary question 3: Did your erection last long enough for you to have successful intercourse? Data are based on participants who responded yes. For the placebo group, onset of efficacy was not reached within the first 4 days of therapy, therefore, the analysis timeframe was expanded for this group to determine the median time to onset of efficacy."|4 days double-blind period|Included in the analysis were all subjects with successful intercourse within the first 4 days of treatment, who have at least 1 baseline observation and who took at least 1 dose of study drug followed by at least 1 intercourse attempt, and who recorded SEP diary data for it within the first 4 days of therapy following randomization.||days||Standard Error|Median
786155|NCT00833638|Secondary|Sexual Encounter Profile Diary Question Number 5, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses|"Assessed was the mean change from baseline in the percentage of yes responses to the Sexual Encounter Profile Diary question number 5: Were you satisfied overall with this sexual experience? Data are presented as the mean percentage of participants who answered yes."|Baseline and 14 days double-blind period|Modified intent-to-treat population consisting of all subjects who have at least 1 baseline observation and who took at least 1 dose of study drug followed by at least 1 intercourse attempt, and who recorded SEP diary data for it within the first 4 days of therapy following randomization.||percentage of participants||Standard Error|Least Squares Mean
786156|NCT00833638|Secondary|Sexual Encounter Profile Diary Question Number 4, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses|"Assessed was the mean change from baseline in the percentage of yes responses to the Sexual Encounter Profile Diary question number 4: Were you satisfied with the hardness of your erection? Data are presented as the mean percentage of participants who answered yes."|Baseline and 14 days double-blind period|Modified intent-to-treat population consisting of all subjects who have at least 1 baseline observation and who took at least 1 dose of study drug followed by at least 1 intercourse attempt, and who recorded SEP diary data for it within the first 4 days of therapy following randomization.||percentage of participants||Standard Error|Least Squares Mean
786157|NCT00833638|Secondary|Sexual Encounter Profile Diary Question Number 3, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses|"Assessed was the mean change from baseline in the percentage of yes responses to the Sexual Encounter Profile Diary question number 3: Did your erection last long enough for you to have successful intercourse? Data are presented as the mean percentage of participants who answered yes."|Baseline and 14 days double-blind period|Modified intent-to-treat population consisting of all subjects who have at least 1 baseline observation and who took at least 1 dose of study drug followed by at least 1 intercourse attempt, and who recorded SEP diary data for it within the first 4 days of therapy following randomization.||percentage of participants||Standard Error|Least Squares Mean
786158|NCT00833638|Secondary|Sexual Encounter Profile Diary Question Number 2, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses|"Assessed was the mean change from baseline in the percentage of yes responses to the Sexual Encounter Profile Diary question number 2: Were you able insert your penis into your partner's vagina? Data are presented as the mean percentage of participants who answered yes."|Baseline and 14 days double-blind period|Modified intent-to-treat population consisting of all subjects who have at least 1 baseline observation and who took at least 1 dose of study drug followed by at least 1 intercourse attempt, and who recorded SEP diary data for it within the first 4 days of therapy following randomization.||percentage of participants||Standard Error|Least Squares Mean
786159|NCT00833638|Secondary|Sexual Encounter Profile Diary Question Number 1, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses|"Assessed was the mean change from baseline in the percentage of yes responses to the Sexual Encounter Profile Diary question number 1: Were you able to achieve at least some erection (some enlargement of the penis)? Data are presented as the mean percentage of participants who answered yes."|Baseline and 14 days double-blind period|Modified intent-to-treat population consisting of all subjects who have at least 1 baseline observation and who took at least 1 dose of study drug followed by at least 1 intercourse attempt, and who recorded SEP diary data for it within the first 4 days of therapy following randomization.||percentage of participants||Standard Error|Least Squares Mean
786160|NCT00833638|Primary|Earliest Onset Day Measured by Cumulative Percentage of Participants With Yes Response to Sexual Encounter Profile Diary Question 3|Cumulative percentage of participants achieving successful intercourse, as measured by “yes” responses to Sexual Encounter Profile diary question 3 (SEP3). SEP3 asks if the participant's erection lasted long enough to have successful intercourse.|4 days during double-blind period|Modified intent-to-treat population consisting of all participants who have at least 1 baseline observation and who took at least 1 dose of study drug followed by at least 1 intercourse attempt, and who recorded SEP diary data for it within the first 4 days of therapy following randomization.||cumulative percentage of participants|||Number
786161|NCT00833664|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Terbinafine in Plasma|Bioequivalence based on AUC0-t|Blood samples collected over 144 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
786162|NCT00833664|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Terbinafine in Plasma|Bioequivalence based on AUC0-inf|Blood samples collected over 144 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
786163|NCT00833664|Primary|Cmax - Maximum Observed Concentration - Terbinafine in Plasma|Bioequivalence based on Cmax|Blood samples collected over144 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
786164|NCT00833690|Secondary|Change in Serum Urate|Change from Last Visit on Study Drug|Safety Visit (SV) from End of Study Drug Visit (ESD); i.e., between +263 and +760 days)|||mg/dL||Standard Deviation|Mean
786165|NCT00833690|Secondary|Change in Serum Urate|Change from an Average of Baseline and Screening Visits|Safety Visit (SV) from Baseline (i.e., between -45 days and +760 days [+1 month after ESD Visit])|||mg/dL||Standard Deviation|Mean
786195|NCT00833690|Secondary|CSF Urate as a Proportion of Baseline Serum Urate (Males)|Although CSF urate was not measured at baseline, the change of CSF urate from baseline may be indirectly estimated by the ratio of CSF urate (at the 12 week visit when a lumbar puncture was performed) to the serum urate measured in the same subject at baseline. Baseline serum urate and CSF urate concentrations are directly correlated with one another (i.e., individuals with higher serum urate concentrations tend to have higher CSF urate concentrations) even though the concentration of urate in CSF is typically ~10% of that in serum. The ratio of CSF urate to baseline serum urate can be expressed as the percentage of the value of urate concentration measured in serum at baseline that is measured in CSF (at week 12).|12 weeks|||percentage of baseline serum urate||Standard Deviation|Mean
786196|NCT00833690|Secondary|CSF Urate as a Proportion of Baseline Serum Urate (Females)|Although CSF urate was not measured at baseline, the change of CSF urate from baseline may be indirectly estimated by the ratio of CSF urate (at the 12 week visit when a lumbar puncture was performed) to the serum urate measured in the same subject at baseline. Baseline serum urate and CSF urate concentrations are directly correlated with one another (i.e., individuals with higher serum urate concentrations tend to have higher CSF urate concentrations) even though the concentration of urate in CSF is typically ~10% of that in serum. The ratio of CSF urate to baseline serum urate can be expressed as the percentage of the value of urate concentration measured in serum at baseline that is measured in CSF (at week 12).|12 weeks|||percentage of baseline serum urate||Standard Deviation|Mean
786197|NCT00833690|Secondary|CSF Urate as a Proportion of Baseline Serum Urate (All Patients)|Although CSF urate was not measured at baseline, the change of CSF urate from baseline may be indirectly estimated by the ratio of CSF urate (at the 12 week visit when a lumbar puncture was performed) to the serum urate measured in the same subject at baseline. Baseline serum urate and CSF urate concentrations are directly correlated with one another (i.e., individuals with higher serum urate concentrations tend to have higher CSF urate concentrations) even though the concentration of urate in CSF is typically ~10% of that in serum. The ratio of CSF urate to baseline serum urate can be expressed as the percentage of the value of urate concentration measured in serum at baseline that is measured in CSF (at week 12).|12 weeks|||percentage of baseline serum urate||Standard Deviation|Mean
786198|NCT00833690|Secondary|CSF Urate (Males)||12 weeks|||mcg/dL||Standard Deviation|Mean
786199|NCT00833690|Secondary|CSF Urate (Females)||12 weeks|||mcg/dL||Standard Deviation|Mean
786200|NCT00833690|Secondary|CSF Urate (All Patients)|Urate concentration in cerebrospinal fluid (CSF)|12 weeks|||mcg/dL||Standard Deviation|Mean
786201|NCT00833690|Primary|Tolerability|Defined as the extent to which assigned treatment could continue without prolonged dose reduction (>48 consecutive days or >73 cumulative days, which is 10% of total 2-year follow-up) due to AEs, and was assessed after 6 and 24 months on study drug. Units of measure are percentage points (i.e., % of participants in the group).|24 months|||percentage of participants|||Number
786202|NCT00833690|Primary|Tolerability|Defined as the extent to which assigned treatment could continue without prolonged dose reduction (>48 consecutive days or >73 cumulative days, which is 10% of total 2-year follow-up) due to adverse experiences (AEs), and was assessed after 6 and 24 months on study drug. Units of measure are percentage points (i.e., % of participants in the group).|6 months|||percentage of participants|||Number
786203|NCT00833703|Primary|Number of Participants According to Bleeding Type/Etiology|For all reported bleeding events, the type and the etiology of the bleeding event were collected. Participants who experienced bleeding events during the 'on-treatment period' were counted by bleeding type and etiology.|Up to a maximum of 6 months|The analysis was performed on the same population as previously (i.e. ITT population).||participants|||Number
786204|NCT00833703|Secondary|Number of Participants With Shunt Thrombosis Requiring Intervention or Deaths|"Outcome events, shunt thrombosis requiring intervention or death, experienced during the study period were recorded.
Participants were counted excluding the events that occured after the participant's protocol study end (occurrence of shunt thrombosis, next surgical procedure for correction of the congenital heart disease, death, or 18 months of age, whichever came first)."|Up to a maximum of 6 months|The analysis was performed on the Intent-to-treat (ITT) population that consisted of all included participants. Participants were analyzed in the treatment arm allocated at randomization into the CLARINET study.||participants|||Number
786205|NCT00833703|Primary|Number of Participants With Bleeding Events|"All bleeding events experienced during the study period were collected as for any Adverse Event.
The 'on-treatment' period was defined as the period from inclusion in the extension study up to 28 days after treatment discontinuation, and participants who experienced bleeding events during that period were counted."|Up to a maximum of 6 months|The analysis was performed on the Intent-to-treat (ITT) population that consisted of all included participants. Participants were analyzed in the treatment arm allocated at randomization into the CLARINET study.||participants|||Number
786206|NCT00839241|Secondary|Lymphocytes||Day 8 postop|||percentage of white blood cells||Standard Deviation|Mean
786207|NCT00839241|Secondary|Lymphocytes||Day 5 postop|||percentage of white blood cells||Standard Deviation|Mean
786208|NCT00839241|Secondary|Lymphocytes||Day 1 postop|||percentage of white blood cells||Standard Deviation|Mean
786209|NCT00839241|Secondary|Lymphocytes||Baseline|||percentage of white blood cells||Standard Deviation|Mean
786210|NCT00839241|Secondary|Leucocyte Particle Concentration||Day 8 postop|||10^3/uL||Standard Deviation|Mean
786211|NCT00839241|Secondary|Leucocyte Particle Concentration||Day 5 postop|||10^3/uL||Standard Deviation|Mean
786212|NCT00839241|Secondary|Leucocyte Particle Concentration||Day 1 postop|||10^3/uL||Standard Deviation|Mean
786213|NCT00839241|Secondary|Leucocyte Particle Concentration||Baseline|||10^3/uL||Standard Deviation|Mean
786214|NCT00839241|Secondary|Erythrocyte Volume Fraction||Day 8 postop|||percentage of blood volume||Standard Deviation|Mean
786215|NCT00839241|Secondary|Erythrocyte Volume Fraction||Day 5 postop|||percentage of blood volume||Standard Deviation|Mean
786216|NCT00839241|Secondary|Erythrocyte Volume Fraction||Day 1 postop|||percentage of blood volume||Standard Deviation|Mean
786217|NCT00839241|Secondary|Erythrocyte Volume Fraction||Baseline|||percentage of blood volume||Standard Deviation|Mean
786218|NCT00839241|Secondary|Hemoglobin||Day 8 postop|||g/dL||Standard Deviation|Mean
786219|NCT00839241|Secondary|Hemoglobin||Day 5 postop|||g/dL||Standard Deviation|Mean
786220|NCT00839241|Secondary|Hemoglobin||Day 1 postop|||g/dL||Standard Deviation|Mean
786246|NCT00839306|Primary|Percentage of Participants With Maintenance of Complete Healing of eGERD at Week 26|"eGERD (erosive gastroesophageal reflux disease) healing measured by the Time-to-Relapse of Oesophageal Erosions using an Esophagogastroduodenoscopy (EGD). Lesions were identified and graded using the following Los Angeles (LA) classification of Oesophagitis: Not Present: No breaks (erosions) in the oesophageal mucosa (however, edema, erythema, or friability may be present).
Grade A: One or more mucosal breaks not more than 5mm in maximum length. Grade B: One or more mucosal breaks more than 5mm in maximum length, but not continuous between the tops of 2 mucosal folds.
Grade C: Mucosal breaks continuous between the tops of 2 or more mucosal folds, but involving less than 75% of the esophageal circumference.
Grade D: Mucosal breaks involving at least 75% of the esophageal circumference."|Baseline to Week 26|Intent-to-Treat (ITT) Population - all randomized subjects who received at least 1 dose of study drug.||Percentage of Participants|||Number
786247|NCT00839306|Secondary|Percentage of Participants With Investigator-recorded Sustained Resolution of Heartburn at Week 26|Heartburn or other GERD-associated symptoms (regurgitation, epigastric or chest pain, dysphagia, belching, bloating, early satiety, other) was based on a 4-point Likert scale that included the following: None (No symptoms); Mild (Awareness of symptoms but easily tolerated); Moderate (Discomforting symptom sufficient to cause interference with normal activities including sleep); Severe (Incapacitating symptom, inability to perform normal activities).|Baseline to Week 26|ITT||Percentage of Participants|||Number
786248|NCT00839319|Primary|Intratesticular Testosterone (ITT-T)||10 days|||IU/L||Inter-Quartile Range|Median
786249|NCT00839319|Primary|Serum Follicle Stimulating Hormone (FSH)||10 days|||IU/L||Inter-Quartile Range|Median
786250|NCT00839319|Primary|Serum Luteinizing Hormone (LH)||10 days|||IU/L||Inter-Quartile Range|Median
786251|NCT00839319|Primary|Serum Testosterone (T)||10 days|Analysis per protocol. Due to nonnormality, the data were expressed as medians and 25th and 75 percentiles. Analysis of both baseline and end of treatment hormone concentrations performed on 31 subjects who completed all study procedures and who suppressed serum LH below the lower limit of normal at end of treatment.||nmol/liter||Inter-Quartile Range|Median
786252|NCT00839423|Secondary|Proportion of Remitters at Week 6 (Remission is Defined as a MADRS Total Score <=10)||Week 6|FAS, LOCF||percentage of patients|||Number
786253|NCT00839423|Secondary|Proportion of Responders at Week 6 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline)||Week 6|FAS, LOCF||percentage of patients|||Number
786254|NCT00839423|Secondary|Change in Clinical Status Using CGI-I Score at Week 6|The Clinical Global Impression - Global Improvement (CGI-I) is a 7-point scale rated from 1 (very much improved) to 7 (very much worse). The investigator rated the patient's overall improvement relative to baseline, whether or not, in the opinion of the investigator, this was entirely due to the drug treatment.|Week 6|FAS, LOCF||units on a scale||Standard Error|Mean
786255|NCT00839423|Secondary|Change From Baseline in CGI-S Score After 6 Weeks of Treatment|The Clinical Global Impression - Severity of Illness (CGI-S) is a 7-point scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The investigator should use his/her total clinical experience with this patient population to judge how mentally ill the patient is at the time of rating.|Baseline and Week 6|FAS, LOCF||units on a scale||Standard Error|Mean
786256|NCT00839423|Secondary|Change From Baseline in HAM-A Total Score After 6 Weeks of Treatment|The Hamilton Anxiety Rating Scale (HAM-A) consists of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behaviour at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic, and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total score from 0 to 56. The higher the score, the more severe.|Baseline and Week 6|FAS, LOCF||units on a scale||Standard Error|Mean
786257|NCT00839423|Secondary|Change From Baseline in HAM-D 24 Total Score After 6 Weeks of Treatment|The 24-item Hamilton Depression Rating Scale (HAM-D) is based on the 21-item HAM-D plus an additional 3 items (helplessness, hopelessness, and worthlessness). The observer makes his/her assessment on the basis of a specific statement, content, tone, facial expression, and gestures of the patient during the interview, and scores each item from 0 to 2 or 0 to 4. Total score from 0 to 76. The higher the score, the more severe.|Baseline and Week 6|FAS, LOCF||units on a scale||Standard Error|Mean
786258|NCT00839423|Secondary|Change From Baseline in MADRS Total Score After 1 Week of Treatment||Baseline and Week 1|FAS, LOCF. Please note that 1 patient in each Vortioxetine group did not have a valid MADRS assessment at Week 1, but were included in the analysis because they had a valid MADRS assessment after Week 1.||units on a scale||Standard Error|Mean
786259|NCT00839423|Primary|Change From Baseline in MADRS Total Score After 6 Weeks of Treatment|The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe.|Baseline and Week 6|Full-analysis set (FAS) – all patients in the all-patients-treated set (APTS) who had at least one valid baseline and one valid post-baseline assessment of the MADRS total score; Last Observation Carried Forward (LOCF)||units on a scale||Standard Error|Mean
786260|NCT00839436|Other Pre-specified|Change: CD4/CD8 T Cell Cts After CYT107; in Immunophenotype (Naive, Memory, Regulatory T Cell Subsets) & Amp; Antigen-specific T Cell Function After CYT107; in T Cell Activation/Proliferation Status & Amp; TCR Repertoire After CYT107; ...||48 weeks per patient with a 3-4 year enrollment period||||||
786261|NCT00839436|Primary|Adverse Events and Toxicities Associated With CYT107.||48 weeks per patient with a 3-4 year enrollment period|||Events|||Number
786262|NCT00841269|Secondary|A Secondary Outcome Measure Includes a Change in YMRS Score||1 year||||||
786263|NCT00841269|Primary|The Primary Neuroimaging Outcome Will be Changes in 3T MRS B-NTP in the Anterior Cingulate.||1 year||||||
786264|NCT00841269|Primary|Mean Scores in Children's Depression Rating Scale (CDRS-R), Assessed Before and After 6 Week Uridine Treatment|The CDRS-R is a 17-item scale, with items rated for severity on a 5 point scale for 3 items and on a 7 point scale for 14 items (possible total score from 17 to 113). Ratings are completed by a clinician via interviews with the child or parent. Scores ≥40 are indicative of depression, whereas scores ≤28 is often used to define remission.|1 year|||Units on a scale||Full Range|Mean
786265|NCT00841321|Secondary|Secondary Outcome: Measures of Self-report as Well as Family Reports of Subject's Cognitive Deficits and Assessment of Social Integration.|"The Perceived Deficits Questionnaire (PDQ), a standardized questionnaire in which the subject reports on his or her cognitive function; Measure total score Range (0 best - 80 worse) Multiple Sclerosis Neuropsychological Screening Questionnaire (MSNQ), in which the family member who was most aware of the participant's cognitive deficits reports on the subject's cognitive deficits; measure total score range (0 best - 60 worse) 'and the Community Integration Questionnaire (CIQ) in which the subject reports his or her degree of social integration; range (0 worst - 32 best); measure total score.
Sub-scales for these 3 measures were not used for outcome measures only total scores."|12 weeks|||units on a scale||Standard Deviation|Mean
786266|NCT00841321|Primary|Primary Outcome is Performance on the Interference Condition of the Stroop, the Long Delay Free Recall Portion of the California Verbal Learning Test II, the 2 Second Paced Auditory Serial Addition Test and the Controlled Oral Word Association Test.|"Performance at exit adjusted for baseline performance on 4 neuropsychological tests:
STROOP(Victoria version):Tests attention&executive function. Outcome is the interference condition condition; time needed to name the colors in which words (which are names of colors) are printed. Words and colors are mismatched.
CaliforniaVerbalLearningTest- II: Tests verbal/learning/memory. Outcome number of words (shopping list) remembered after 20 min delay with no cues.
PacedAuditorySerialAdditionTest:Tests working memory/sustained attention. Outcome is the number of correct responses to recording giving numbers every 2 sec. Last 2 numbers must be added together before the next number.
ControlledOralWordAssociationTest:Tests letter fluency. Outcome number of words produced in one minute for each of 3 letters.
Measures reported as Z-scores based on the available population norms for each test; range -infinite +infinite; 0 average; -1=1std below average; +1=1std above average."|12 weeks|Data of all 120 participants was analyzed. For subjects with missing exit values (1 placebo, 2 ginkgo) the baseline measures were carried forward in the analysis.||z-scores||Standard Deviation|Mean
786267|NCT00841412|Primary|Quality of Feeding Assistance Care Processes|"Research staff observed each participant during six meals per study phase. Research staff documented the total amount of staff time spent providing feeding assistance and each type of assistance per resident per meal. These data were used to construct standardized feeding assistance care quality indicators wherein the number of resident meal observations was variable. For example, one indicator was defined as: Percentage of meals during which resident intake was below 50% and staff offered and alternative to the served meal. Thus, the denominator for total number of observed meals scored varied by indicator. There were multiple indicators; thus, there is inadequate space to provide an adequate description of each measure and the corresponding scoring rules here. Please refer to published papers for a complete description of all outcome measures."|3 month intervention and 3 month follow up periods|Each participants was observed during six scheduled meals per person per study phase. A total of 130 participants completed all study phases and had complete data for analyses.||percentage of meal observations|Participants||Number
786268|NCT00841542|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 168 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
786269|NCT00841542|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 168 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
786270|NCT00841542|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 168 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
786271|NCT00841555|Secondary|Time Spent in a Karnofsky Performance Status of 60-100%|Time spent in a KPS ≥70 was calculated from the date of diagnosis of Karonofsky Performance Status decline (KPS<70) or censored at the last date the patient was known with KPS ≥70. The KPS higher scores indicates normal activity status.|up to 12-16 months|Kaplan-Meier analysis for time spent in a Karnofsky performance status (KPS) ≥70||months||95% Confidence Interval|Median
786272|NCT00841555|Secondary|Survival Time|All patients will be followed to death. Active follow-up with disease evaluation with scans will be terminated if the patient’s physician deems it in the patient’s interest not to continue or upon patient request.|up to 2 years|||months||95% Confidence Interval|Median
786273|NCT00841555|Secondary|Time to Neuroradiological Evidence of Tumor Recurrence or Progression|As a small phase I study, no inferential statistical tests of hypotheses are planned. Data collected will be providing descriptive summary statistics. However, these estimates will allow statistically sound experimental designs and sample size calculations for subsequent studies of therapeutic effect.|up to 12-16 months||||||
786274|NCT00841555|Primary|Maximum Tolerated Dose(MTD)of Temozolomide(TMZ)|This study is designed as a phase I dose escalation trial using the Standard Method of dose escalation of three patients per dose level to determine the MTD of TMZ (up to 75 mg/m 2 /day) when TMZ is used with HIMRT for patients with glioblastoma multiforme(GBM) or Anaplastic Astrocytoma(AA)of the brain. The 3 dose levels will be evaluated using the standard method to determine if either represents an MTD based on DLT. If DLT is not observed at all doses level, the greater of the three levels will be recommended for phase II evaluations of treatment effect.|up to 12-16 months|||mg/m^2|||Number
786275|NCT00841659|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 120 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
786276|NCT00841659|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 120 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
786277|NCT00841659|Primary|Cmax - Maximum Observed Concentration (of Paroxetine in Plasma)|Bioequivalence based on Cmax|Blood samples collected over 120 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
786278|NCT00841672|Secondary|Blood Pressure Control|Percentage of patients achieving blood pressure control (msSBP < 140 mm Hg and msDBP < 90 mm Hg) at end of study|End of study (Week 8)|Full Analysis Set - analysis set was the FAS excluding patients from one center due to Good Clinical Practices (GCP) issues||Percentage of participants|||Number
786279|NCT00841672|Secondary|Diastolic Blood Pressure Response|Percentage of patients achieving a mean sitting diastolic blood pressure response (msDBP < 90 mmHg or a reduction ≥ 10 mmHg from the baseline) from baseline to end of study (Week 8)|Baseline to end of study (Week 8)|Full Analysis Set - analysis set was the FAS excluding patients from one center due to Good Clinical Practices (GCP) issues All randomized patients who received the study medication. The measurement at Week 8 was used unless it was not available, in which case, the last observation carried forward was used.||Percentage of participants|||Number
786280|NCT00841672|Secondary|Systolic Blood Pressure Response|Percentage of patients achieving a mean sitting systolic blood pressure response (msSBP < 140 mmHg or a reduction => 20 mmHg from the baseline) from baseline to end of study (Week 8)|Baseline to end of study (Week 8)|Full Analysis Set - analysis set was the FAS excluding patients from one center due to GCP issues||Percentage of participants|||Number
786281|NCT00841672|Secondary|Mean Sitting Diastolic Blood Pressure (msDBP)|Change in mean sitting diastolic blood pressure (msDBP) from baseline to end of study (Week 8)|Baseline to end of study (Week 8)|Full Analysis Set - analysis set was the FAS excluding patients from one center due to Good Clinical Practices (GCP) issues||mm Hg||Standard Error|Least Squares Mean
786282|NCT00841672|Primary|Mean Sitting Systolic Blood Pressure (msSBP)|Change in mean sitting systolic blood pressure (msSBP) from baseline to end of study (Week 8)|Baseline to end of study (Week 8)|Full Analysis Set - analysis set was the FAS excluding patients from one center due to Good Clinical Practices (GCP) issues||mm Hg||Standard Error|Least Squares Mean
786283|NCT00841698|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 120 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
786284|NCT00841698|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 120 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
786285|NCT00841698|Primary|Cmax - Maximum Observed Concentration (of Paroxetine in Plasma)|Bioequivalence based on Cmax|Blood samples collected over 120 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
786286|NCT00841763|Secondary|Percentages of Participants Achieving Seroconversion or Significant Increase in Antibody Titers, After Two Doses of the Adjuvanted Pandemic H5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.|To evaluate the immunogenicity of two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1), each containing 7.5µg of H5N1 antigen, against the heterologous A/turkey/Turkey/1/2005 strain, in terms of percentage of subjects achieving significant increase or at least 4-Fold increase in antibody titers from baseline as measured by HI, MN and SRH assays.|3 weeks after vaccination (day 43/day 22 and day 64/day 22)|This analysis was performed on the Full Analysis Set population.||Percentages of participants||95% Confidence Interval|Number
786287|NCT00841763|Secondary|Percentages of Participants Achieving Geometric Mean Titers ≥ 40 and Geometric Mean Areas ≥ 25mm2, After Two Doses of the Adjuvanted Pandemic H5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain|"To evaluate the immunogenicity of two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1), each containing 7.5µg of H5N1 antigen, against the heterologous A/turkey/Turkey/1/2005 strain, in terms of percentage of subjects achieving Geometric Mean Titers ≥ 40 and Geometric Mean Areas (GMA) ≥ 25mm2 as determined by HI, MN and SRH assays.
GMA: For each vaccine group, least squares GMAs (for SRH data), associated 2-sided 95% confidence interval and median, minimal, and maximal titer value were determined for study day 22,43 and 64."|3 weeks after vaccination (day 22, day 43, day 64)|This analysis was performed on the Full Analysis set population.||Percentages of participants||95% Confidence Interval|Number
786288|NCT00841763|Secondary|Geometric Mean Ratios After Two Doses of the Adjuvanted Pandemic H5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.|To evaluate the immunogenicity of two doses of the adjuvanted pandemic H5N1 Vaccine (MF59-eH5N1), each containing 7.5µg of H5N1 antigen, in terms of Geometric Mean Ratios (GMRs) against the heterologous A/turkey/Turkey/1/2005 strain, as determined by HI,MN and SRH assays.|3 weeks after vaccination (day 43/day 22 and day 64/day 22)|This analysis was performed on the Full Analysis set population.||Ratios||95% Confidence Interval|Geometric Mean
786289|NCT00841763|Secondary|Geometric Mean Areas After Two Doses of the Adjuvanted Pandemic H5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.|"To evaluate the immunogenicity of two doses of MF59-eH5N1, each containing 7.5µg of H5N1 antigen, in terms of Geometric Mean Areas (GMAs) against the heterologous A/turkey/Turkey/1/2005 strain, as determined by SRH assay.
GMA: For each vaccine group, least squares GMAs (for SRH data), associated 2-sided 95% confidence interval and median, minimal, and maximal titer value were determined for study day 22,43 and 64."|3 weeks after vaccination (day 22, day 43, day 64)|This analysis was performed on the Full Analysis Set population.||Areas (mm^2)||95% Confidence Interval|Geometric Mean
786290|NCT00841763|Secondary|Geometric Mean Titers After Two Doses of the Adjuvanted Pandemic H5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.|To evaluate the immunogenicity of two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1), each containing 7.5µg of H5N1 antigen, in terms of Geometric Mean Titers (GMTs) against the heterologous A/turkey/Turkey/1/2005 strain, as determined by HI and MN assays.|3 weeks after vaccination (day 22, day 43, day 64)|This analysis was performed on the Full Analysis set population.||Titers||95% Confidence Interval|Geometric Mean
786291|NCT00841763|Secondary|Percentages of Participants Achieving Seroconversion or Significant Increase in Antibody Titer After Two Doses of the Adjuvanted Pandemic H5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain|To evaluate the immunogenicity of two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1), each containing 7.5µg of H5N1 antigen, against the homologous A/Vietnam/1194/2004 strain, in terms of percentage of subjects achieving significant increase or at least 4-Fold increase in antibody titer from baseline, as measured by HI, MN and SRH assays.|3 weeks after vaccination (day 43/day22 and day 64/day22)|This analysis was performed on the Full Analysis Set population||Percentages of participants||95% Confidence Interval|Number
786382|NCT00842751|Primary|Serum Estradiol Concentration|Area under the curve of serum estradiol|0,1,2,4,8,and 12-hour post dose|All participants received all treatment, and is therefore, included in the analysis population for all three treatment groups.||ng*hr/dL||Inter-Quartile Range|Geometric Mean
786292|NCT00841763|Secondary|Percentages of Participants Achieving Geometric Mean Titers ≥ 40 and Geometric Mean Areas ≥ 25mm2, After Two Doses of the Adjuvanted Pandemic H5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain)|"To evaluate the immunogenicity of two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1), each containing 7.5µg of H5N1 antigen, against the homologous A/Vietnam/1194/2004 strain, in terms of percentage of subjects achieving Geometric Mean Titers ≥ 40 and Geometric Mean Areas (GMA) ≥ 25mm2, as determined by HI, MN and SRH assays.
GMA: For each vaccine group, least squares GMAs (for SRH data), associated 2-sided 95% confidence interval and median, minimal, and maximal titer value were determined for study day 22,43 and 64."|3 weeks after vaccination (day 22, day 43, day 64)|The analysis was performed on the Full Analysis Set (FAS) of the Immunogenicity Subset.||Percentages of participants||95% Confidence Interval|Number
786293|NCT00841763|Secondary|Geometric Mean Ratios After Two Doses of the Adjuvanted Pandemic H5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain|To evaluate the immunogenicity of two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1), each containing 7.5µg of H5N1 antigen,in terms of Geometric Mean Ratio(GMRs) against the homologous A/Vietnam/1194/2004 strain, as determined by HI, MN and SRH assays.|3 weeks after vaccination (day 43/day22, day 64/day43)|The analysis was performed on the Full Analysis Set (FAS) of the Immunogenicity Subset.||Ratios||95% Confidence Interval|Geometric Mean
786294|NCT00841763|Secondary|Geometric Mean Areas After Two Doses of the Adjuvanted Monovalent Influenza Virus Vaccine (aH5N1)|"To evaluate the immunogenicity of two doses of the adjuvanted monovalent influenza virus vaccine (aH5N1), in terms of Geometric Mean Areas (GMAs) as determined by Single Radial Haemolysis(SRH) assay.
GMA: For each vaccine group, least squares GMAs (for SRH data), associated 2-sided 95% confidence interval and median, minimal, and maximal titer value were determined for study day 22,43 and 64."|3 weeks after vaccination (day22, day 43, day 64)|The analysis was performed on the Full Analysis Set (FAS) of the Immunogenicity Subset.||Areas (mm^2)||95% Confidence Interval|Geometric Mean
786295|NCT00841763|Secondary|Geometric Mean Titers After Two Doses of the Adjuvanted Pandemic H5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain|To evaluate the immunogenicity of two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1), each containing 7.5µg of H5N1 antigen,in terms of Geometric Mean Titers(GMTs) against the homologous A/Vietnam/1194/2004 strain, as determined by hemagglutination Inhibition(HI) assay and Microneutralization(MN) assay.|3 weeks after vaccination (day 22, day 43, day 64)|The analysis was performed on the Full Analysis Set (FAS) of the Immunogenicity Subset.||Titers||95% Confidence Interval|Geometric Mean
786296|NCT00841763|Secondary|The Number of Participants With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic H5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine|To evaluate the safety and tolerability profile of two dose of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1) as compared with the MF59-adjuvanted seasonal trivalent influenza vaccine (MF59-eTIV), in terms of the number of participants who reported local and systemic reactions up to 7 days after each vaccination per vaccination group.|Up to 7 days after each vaccination|The analysis was performed on the Safety set population||Participants|||Number
786297|NCT00841763|Primary|Number of Participants With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic Influenza Vaccine|To assess the safety and tolerability profile of two doses of the MF59-adjuvanted A/Vietnam/1194/2004 (H5N1 Clade 1) pandemic influenza vaccine (MF59-eH5N1), each containing 7.5 μg of H5N1 antigen in terms of the number of participants who reported local and systemic reactions up to 7 days after each vaccination per vaccination group.|Up to 7 days after each vaccination|The analysis was performed on the Safety Set population||Participants|||Number
786298|NCT00841776|Secondary|Median Change in Noninflammaotry Acne Counts|Median Change in Noninflammaotry Acne Counts|Baseline, Weeks 2, 4, 8, 12, and 16|||Noninflammatory lesion counts||Inter-Quartile Range|Median
786299|NCT00841776|Secondary|Median Change in Inflammatory Acne Lesion Counts|Median Change in Inflammatory Acne Lesion Counts|Baseline, Weeks 2, 4, 8, 12, and 16|ITT||Lesion Counts||Inter-Quartile Range|Median
786300|NCT00841776|Secondary|Median Change in Total Acne Lesions|Median Change in Total Acne Lesions|Baseline, Weeks 2, 4, 8, 12, and 16|ITT||Total Acne Lesion Counts||Inter-Quartile Range|Median
786301|NCT00841776|Secondary|Median Change in Erythromycin-resistant P. Acne Counts|Total colony forming units of erythromycin-resistant p. acnes.|Baseline, Weeks 2, 4, 8, 12, and 16|ITT||Erythromycin-resistant P. acne counts||Inter-Quartile Range|Median
786302|NCT00841776|Secondary|Median Change in Clindamycin Resistant P. Acne.|Median change in total colony forming units of clindamycin resistant p. acne.|Baseline, Weeks 2, 4, 8, 12, 16|ITT||Clindamycin- resistant P. acne counts||Inter-Quartile Range|Median
786303|NCT00841776|Primary|Median Change in Total Propionibacterium Acne (P.Acne) Counts|Median change in total colony forming units of propionibacterium acne (P.acne) will be counted.|Baseline, Weeks 2, 4, 8, 12, & 16|||P. acne counts||Inter-Quartile Range|Median
786304|NCT00841815|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 168 hour period|Data from all subjects who completed the study were included in the statistical analysis||ng*h/mL||Standard Deviation|Mean
786305|NCT00841815|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 168 hour period|Data from all subjects who completed the study were included in the statistical analysis||ng*h/mL||Standard Deviation|Mean
786306|NCT00841815|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 168 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
786307|NCT00841906|Secondary|The Secondary Objective of This Study is to Compare the Measurements of the Alice PDx When Patients Complete the Set-up of the Device at Home and When Patients Are Set up by a Sleep Technician in the Sleep Laboratory.|"The Alice PDx incorporates a unique Good Study Indicator (GSI). The GSI is a predicated on airflow and oximeter signal quality and displays the amount of good quality data needed for a study to be complete and valid. The GSI visually displays the amount of good quality data in 25-percent increments on the Alice PDx screen. For purposes of this secondary objective this number was compared from participants who set-up and wore the device at home and those that wore the device in a sleep lab set up by a sleep technician."|overnight|||percentage of good Study Indicator||Standard Deviation|Mean
786308|NCT00841906|Primary|This Study Will Compare Different Measurements Recorded by the Alice PDx to the Measurement Data Recorded by Its Predicate Device the Alice 5 System and Validate Its Equivalence.|This study will compare different measurements recorded which include Time in Bed, Stage N1, Stage N2, Stage N3, REM, Sleep Onset Latency, Total Sleep Time, Wake Time in Bed and Wake After Sleep Onset by the Alice PDx to the measurement data recorded by its predicate device the Alice 5 System and validate its equivalence.|Lab Night|All participants that completed the overnight portion of the study were analyzed.||minutes||Standard Deviation|Mean
786309|NCT00841906|Primary|This Study Will Compare the Central Apnea Index, Hypopnea Index, Mixed Apnea Index and Obstructive Apnea Index Recorded by the Alice PDx to the Physiological Data Recorded by Its Predicate Device the Alice 5 System and Validate Its Equivalence.||Lab Night|All participants that completed the overnight portion of the study were analyzed.||events/hour||Standard Deviation|Mean
786310|NCT00841906|Primary|This Study Will Compare the Apnea Hypopnea Index Recorded by the Alice PDx to the Physiological Data Recorded by Its Predicate Device the Alice 5 System and Validate Its Equivalence.||Lab Night|All participants that completed the overnight portion of the study were analyzed.||events||Standard Deviation|Mean
786311|NCT00841971|Secondary|Need for Additional Antifungal Therapy||90 days post enrollment|||participants|||Number
786312|NCT00841971|Primary|Frequency of Fungal Infection||90 days post enrollment|||participants|||Number
786313|NCT00842023|Other Pre-specified|Serum Levels of Cystatin-C|Cystatin-C is a protease inhibitor and a sensitive endogenous marker of renal function.|Baseline, 24 hours, 48 hours|Only participants with available data were assessed for this outcome measure.||ng/mL||Standard Deviation|Mean
786314|NCT00842023|Other Pre-specified|Inflammatory Markers|Interleukin-6|48 hours|Only participants with available data were assessed for this outcome measure.||pg/mL||Standard Error|Mean
786315|NCT00842023|Primary|Renal Function by Serum Creatinine|Serum creatinine values and changes in serum creatinine|Baseline, 24 hours, 48 hours|||mg/dL||Standard Deviation|Mean
786316|NCT00842075|Secondary|Weight Change After 28 Days Intervention Period|Mean weight change after 28 days intervention period|28 days|||kg||Standard Deviation|Mean
786317|NCT00842075|Primary|HbA1c Value After 28 Days|HbA1c values 28 days after randomization|28|pilot study||HbA1c %||Standard Deviation|Mean
786383|NCT00842751|Primary|Serum Dihydrotestosterone Concentration|Area under the curve of serum dihydrotestosterone|0,1,2,4,8,and 12-hour post dose|All participants received all treatment, and is therefore, included in the analysis population for all three treatment groups.||ng*hr/dL||Inter-Quartile Range|Geometric Mean
786335|NCT00842231|Primary|Reading Acuity and Speed|Reading Acuity and Speed differences between subjects tested with full correction and spherical equivalent (SE) correction. Reading Acuity was measured using the Radner reading charts, which are logarithmically scaled at different acuity levels (print sizes), and expressed in terms of logRAD (logrithmic Reading Acuity Determination). Reading speed was measured in words per minute (wpm). The results were presented as Average Reading Speed by Print Size (logRAD).|Day of Study Visit|Data was collected for 40 eyes in 40 subjects. Only one operative eye of each subject was included in the study. If both eyes qualified, the dominant eye was selected.||words per minute||95% Confidence Interval|Least Squares Mean
786336|NCT00842231|Primary|Contrast Sensitivity|Contrast Sensitivity (CS) differences between subjects tested with full correction & spherical equivalent (SE) correction. CS is the measurement of one's ability to detect slight changes in luminance before it becomes indistinguishable. CS is measured in logarithmic units by means of an illuminated box, the CSV 1000 by Vector Vision. Testing was performed under photopic conditions (no glare) & mesopic conditions (with & without glare), and was measured at four spatial frequencies of 3, 6, 9, and 12 cycles per degree (cpd). A higher value for the logarithmic units translates to better CS.|Day of Study Visit|Data was collected for 40 eyes in 40 subjects. Only one operative eye of each subject was included in the study. If both eyes qualified, the dominant eye was selected.||Logrithmic Units||Standard Deviation|Mean
786337|NCT00842231|Primary|High and Low Contrast Acuity|Visual acuity differences between subjects tested with full correction and spherical equivalent (SE) correction at contrast levels of 9% and 25% (low contrast acuity) and 100% (high contrast acuity). LogMAR is the “logarithm of the minimum angle of resolution”. A lower logMAR value indicates better VA. These measurements were performed under photopic conditions by means of 9%, 25%, and 100% contrast ETDRS (Early Treatment Diabetic Retinopathy Study) charts (Vector Vision).|Day of study visit|Data was collected for 40 eyes in 40 subjects. Only one operative eye of each subject was included in the study. If both eyes qualified, the dominant eye was selected.||logMAR||Standard Deviation|Mean
786338|NCT00842244|Secondary|Progression-Free Survival (PFS)|"Time in months from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death). PD was a>=20% increase in sum of the longest dimensions of target lesions taking as a reference the smallest sum of the longest dimensions recorded since the treatment started, or the appearance of 1 or more new lesions."|Baseline up to disease progression or withdrawal, assessed on Day 21 of every other cycle starting from Cycle 2 up to Day 784|Efficacy analysis set included all enrolled participants who received at least 1 dose of study medication, had measurable disease at baseline (according to RECIST criteria version 1.0), and had at least 1 tumor assessment during study.||months||95% Confidence Interval|Median
786339|NCT00842244|Secondary|Duration of Response (DR)|Time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response. CR = disappearance of all target lesions. PR = at least 30% decrease in sum of the longest dimensions of target lesions taking the baseline sum of the longest dimensions as a reference.|Baseline up to disease progression or withdrawal, assessed on Day 21 of every other cycle starting from Cycle 2 up to Day 784|Analysis set included a subset of efficacy analysis set who had confirmed objective tumor response.||months||95% Confidence Interval|Median
786340|NCT00842244|Secondary|Percentage of Participants With Objective Response (OR)|Number of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed response are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are those with disappearance of all target lesions. PR are those with at least 30 percent (%) decrease in sum of the longest dimensions of target lesions taking the baseline sum of the longest dimensions as a reference.|Baseline up to disease progression or withdrawal, assessed on Day 21 of every other cycle starting from Cycle 2 up to Day 784|Efficacy analysis set included all enrolled participants who received at least 1 dose of study medication, had measurable disease at baseline (according to RECIST criteria version 1.0), and had at least 1 tumor assessment during study.||percentage of participants||95% Confidence Interval|Number
786341|NCT00842244|Secondary|Drug Metabolizing Enzyme Genotyping|Genetic variants of uridine diphosphate (UDP)- glucuronosyl transferase 1A1 (UGT1A1) gene which were assessed for genotyping included UGT1A1*60, UGT1A1-3156, UGT1A1 Promoter thymine adenine (TA) repeat (UGT1A1*28, UGT1A1*36, UGT1A1*37), UGT1A1*6 and UGT1A1*27.|Day 1 of Cycle 1|Results are not reported because data was reported in individual participant listing but not statistically summarized for the analysis.|||||
786342|NCT00842244|Secondary|Volume of Distribution (Vz) for Cisplatin|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Clearance for cisplatin (assessed by estimating total platinum in plasma ultrafiltrate) in presence of steady-state axitinib was evaluated on Cycle 1 Day 1 and in absence of axitinib (cisplatin alone) on Cycle 2 Day 1.|0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 hrs post-cisplatin infusion start on C1D1, C2D1|Pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||Liter||95% Confidence Interval|Geometric Mean
786343|NCT00842244|Secondary|Apparent Volume of Distribution (Vz/F) for Axitinib, Capecitabine and Capecitabine's Metabolites|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vz/F is influenced by the fraction absorbed. Vz/F for axitinib in absence of chemotherapy (axitinib alone) was evaluated on Cycle 1 Day -1 and in combination with chemotherapy on Cycle 1 Day 1. Vz/F for capecitabine in presence of steady-state axitinib was evaluated on Cycle 1 Day 1 and in absence of axitinib (capecitabine alone) on Cycle 2 Day 1.|0 (pre-dose), 1, 2, 3, 4, 6, 8 hrs post-axitinib dose on C1D-1, C1D1; 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hrs post-capecitabine dose on C1D1, C2D1|Pharmacokinetic parameter analysis set. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' = participants evaluable for specified study drug's PK parameter alone or in combination. Results are not reported for capecitabine metabolites because Vz/F could not be accurately estimated.||Liter||95% Confidence Interval|Geometric Mean
786344|NCT00842244|Secondary|Clearance (CL) for Cisplatin|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. It is defined as the volume of blood from which drug can be completely removed per unit of time. Clearance for cisplatin (assessed by estimating total platinum in plasma ultrafiltrate) in presence of steady-state axitinib was evaluated on Cycle 1 Day 1 and in absence of axitinib (cisplatin alone) on Cycle 2 Day 1.|0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 hrs post-cisplatin infusion start on C1D1, C2D1|Pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||Liter/hr||95% Confidence Interval|Geometric Mean
786345|NCT00842244|Secondary|Apparent Oral Clearance (CL/F) for Axitinib, Capecitabine and Capecitabine's Metabolites|Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed (F). Clearance is defined as the volume of blood from which drug can be completely removed per unit of time. CL/F for axitinib in absence of chemotherapy (axitinib alone) was evaluated on Cycle 1 Day -1 and in combination with chemotherapy on Cycle 1 Day 1. CL/F for capecitabine in presence of steady-state axitinib was evaluated on Cycle 1 Day 1 and in absence of axitinib (capecitabine alone) on Cycle 2 Day 1.|0 (pre-dose), 1, 2, 3, 4, 6, 8 hrs post-axitinib dose on C1D-1, C1D1; 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hrs post-capecitabine dose on C1D1, C2D1|Pharmacokinetic parameter analysis set. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' = participants evaluable for specified study drug's PK parameter alone or in combination. Results are not reported for capecitabine metabolites because CL/F could not be accurately estimated.||Liter/hr||95% Confidence Interval|Geometric Mean
786346|NCT00842244|Secondary|Plasma Decay Half-Life (t1/2) for Axitinib, Capecitabine, Capecitabine's Metabolites and Cisplatin|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Plasma decay half life for axitinib in absence of chemotherapy (axitinib alone) was evaluated on Cycle 1 Day -1 and in combination with chemotherapy on Cycle 1 Day 1. Plasma decay half life for cisplatin (assessed by estimating total platinum in plasma ultrafiltrate), capecitabine and capecitabine’s metabolites (5-FU, 5-DFUR and 5-DFC) in presence of steady-state axitinib were evaluated on Cycle 1 Day 1 and in absence of axitinib (cisplatin/capecitabine alone) on Cycle 2 Day 1.|0 (pre-dose), 1, 2, 3, 4, 6, 8 hrs post-axitinib dose on C1D-1, C1D1; 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hrs post-capecitabine dose C1D1, C2D1; 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 hrs post-cisplatin infusion start C1D1, C2D1|Pharmacokinetic parameter analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here, 'n' signifies those participants who were evaluable for specified study drug's PK parameter alone or in combination.||hrs||Standard Deviation|Mean
786347|NCT00842244|Secondary|Area Under the Curve From Time Zero Extrapolated to Infinite Time [AUC (0 - ∞)] for Axitinib, Capecitabine, Capecitabine's Metabolites and Cisplatin|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) extrapolated to infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). AUC (0 - ∞) for axitinib in absence of chemotherapy (axitinib alone) was evaluated on Cycle 1 Day -1 and in combination with chemotherapy on Cycle 1 Day 1. AUC (0 - ∞) for cisplatin (assessed by estimating total platinum in plasma ultrafiltrate), capecitabine and capecitabine’s metabolites (5-FU, 5-DFUR and 5-DFC) in presence of steady-state axitinib were evaluated on Cycle 1 Day 1 and in absence of axitinib (cisplatin/capecitabine alone) on Cycle 2 Day 1. Results for axitinib were normalized to axitinib 5 mg dose, results for capecitabine and its metabolites (5-FU, 5-DFUR and 5-DFC) were normalized to Cycle 1 Day 1 capecitabine dose and results for cisplatin were normalized to Cycle 1 Day 1 cisplatin dose.|0 (pre-dose), 1, 2, 3, 4, 6, 8 hrs post-axitinib dose on C1D-1, C1D1; 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hrs post-capecitabine dose C1D1, C2D1; 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 hrs post-cisplatin infusion start C1D1, C2D1|Pharmacokinetic parameter analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here, 'n' signifies those participants who were evaluable for specified study drug's PK parameter alone or in combination.||ng*hr/mL||95% Confidence Interval|Geometric Mean
786348|NCT00842244|Secondary|Area Under the Curve From Time Zero to 24 Hours [AUC (0-24)] for Axitinib|AUC (0-24) = Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours. AUC (0-24) for axitinib in absence of chemotherapy (axitinib alone) was evaluated on Cycle 1 Day -1 and in combination with chemotherapy on Cycle 1 Day 1. Results for axitinib were normalized to axitinib 5 mg dose.|0 (pre-dose), 1, 2, 3, 4, 6, 8 hrs post-axitinib dose on C1D-1, C1D1|Pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||ng*hr/mL||95% Confidence Interval|Geometric Mean
786384|NCT00842751|Primary|Maximum Testosterone Concentration|Area under the curve of serum testosterone Pharmacokinetic measures time-weighted mean concentration calculated as area under the concentration curve (AUC) divided by time from initiation of dosing for the morning dose and corrected for differences in baseline hormone concentration.|0,1,2,4,8,and 12-hour post dose|All participant received all treatments and is, therefore, included in the analysis population for all groups.||ng*hr/dL||Inter-Quartile Range|Geometric Mean
786349|NCT00842244|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Capecitabine, Capecitabine's Metabolites and Cisplatin|Area under the plasma concentration time-curve from zero to the last measurable concentration (AUClast). AUClast for cisplatin (assessed by estimating total platinum in plasma ultrafiltrate), capecitabine and capecitabine’s metabolites (5-FU, 5-DFUR, 5-DFC) in presence of steady-state axitinib were evaluated on Cycle 1 Day 1 and in absence of axitinib (cisplatin/capecitabine alone) on Cycle 2 Day 1. Results for capecitabine and its metabolites (5-FU, 5-DFUR and 5-DFC) were normalized to Cycle 1 Day 1 capecitabine dose and results for cisplatin were normalized to Cycle 1 Day 1 cisplatin dose.|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hrs post-capecitabine dose C1D1, C2D1; 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 hrs post-cisplatin infusion start C1D1, C2D1|Pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||nanogram*hour/milliliter (ng*hr/mL)||95% Confidence Interval|Geometric Mean
786350|NCT00842244|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) for Axitinib, Capecitabine, Capecitabine's Metabolites and Cisplatin|Tmax for axitinib in absence of chemotherapy (axitinib alone) was evaluated on Cycle 1 Day -1 and in combination with chemotherapy on Cycle 1 Day 1. Tmax for cisplatin (assessed by estimating total platinum in plasma ultrafiltrate), capecitabine and capecitabine’s metabolites (5-FU, 5-DFUR and 5-DFC) in presence of steady-state axitinib were evaluated on Cycle 1 Day 1 and in absence of axitinib (cisplatin/capecitabine alone) on Cycle 2 Day 1.|0 (pre-dose), 1, 2, 3, 4, 6, 8 hrs post-axitinib dose on C1D-1, C1D1; 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hrs post-capecitabine dose C1D1, C2D1; 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 hrs post-cisplatin infusion start C1D1, C2D1|Pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. Here, 'n' signifies those participants who were evaluable for specified study drug's PK parameter alone or in combination.||hrs||Full Range|Median
786351|NCT00842244|Secondary|Maximum Observed Plasma Concentration (Cmax) for Axitinib, Capecitabine, Capecitabine's Metabolites and Cisplatin|Cmax for axitinib in absence of chemotherapy (axitinib alone) was evaluated on Cycle 1 Day -1 and in combination with chemotherapy on Cycle 1 Day 1. Cmax for cisplatin (assessed by estimating total platinum in plasma ultrafiltrate), capecitabine and capecitabine’s metabolites (5-fluorouracil [5-FU], 5-deoxy-5-fluorouridine [5-DFUR] and 5-deoxy-5-fluorocytidine [5-DFC]) in presence of steady-state axitinib were evaluated on Cycle 1 Day 1 and in absence of axitinib (cisplatin/capecitabine alone) on Cycle 2 Day 1. Results for axitinib were normalized to axitinib 5 mg dose, results for capecitabine and its metabolites (5-FU, 5-DFUR and 5-DFC) were normalized to Cycle 1 Day 1 capecitabine dose and results for cisplatin were normalized to Cycle 1 Day 1 cisplatin dose.|0 (pre-dose), 1, 2, 3, 4, 6, 8 hrs post-axitinib dose on Cycle 1 (C1) Day -1 (D-1), C1D1; 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hrs post-capecitabine dose C1D1, C2D1; 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 hrs post-cisplatin infusion start C1D1, C2D1|Pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. Here, 'n' signifies those participants who were evaluable for specified study drug's PK parameter alone or in combination.||nanogram/milliliter (ng/mL)||95% Confidence Interval|Geometric Mean
786352|NCT00842244|Other Pre-specified|Maximum Tolerated Dose (MTD) of Axitinib (AG-013736) in Combination With Cisplatin and Capecitabine|MTD = highest dose at which no more than 30 percent (%) of 12 participants experience DLT during Cycle 1. DLT = GR2 proteinuria; GR3 NHT (excluding alopecia and those that can be controlled with appropriate treatment)for >=7 days, GR3 thrombocytopenia with active bleeding; GR >=3 febrile NP/NP infection; GR 3 or 4 nausea, vomiting or diarrhea despite anti-emetics, anti-diarrheals; GR4 NHT, thrombocytopenia, NP for >=7 days; >= 1/2 teaspoon per day hemoptysis; any treatment-related toxicity with >3 consecutive days of capecitabine or 5 consecutive days of axitinib missed doses per cycle; delayed toxicity recovery >14 days.|Baseline up to Day 21 of Cycle 1|DLT analysis set: participants who received first cycle of study treatment and did not temporarily or permanently discontinue or miss more than 5 consecutive days of axitinib (AG-13736) or more than 3 consecutive days of capecitabine for reasons other than DLTs within first cycle.||mg|||Number
786353|NCT00842244|Primary|Number of Participants With Cycle 1 Dose-limiting Toxicities (DLTs)|DLT = Grade (GR) 2 proteinuria; GR3 nonhematological toxicity (NHT) (excluding alopecia and those that can be controlled with appropriate treatment) for greater than or equal to (>=)7 days, GR3 thrombocytopenia with active bleeding; GR >=3 febrile neutropenia (NP) or NP infection; GR 3 or 4 nausea, vomiting or diarrhea despite anti-emetics, anti-diarrheals; GR4 NHT, thrombocytopenia, NP for >=7 days; >= 1/2 teaspoon per day hemoptysis; any treatment related toxicity with >3 consecutive days of capecitabine or 5 consecutive days of axitinib missed doses per cycle; delayed toxicity recovery >14 days.|Baseline up to Day 21 of Cycle 1|DLT analysis set: participants who received first cycle of study treatment and did not temporarily or permanently discontinue or miss more than 5 consecutive days of axitinib (AG-13736) or more than 3 consecutive days of capecitabine for reasons other than DLTs within first cycle.||participants|||Number
786354|NCT00842257|Secondary|Disease Control Rate as Defined by RECIST Criteria|Disease Control Rate as defined by RECIST criteria. The number patients achieving stable disease, partial response, or complete response at some point during follow-up.|3 years|One patient withdrawn for an infusion reaction prior to first re-staging CT scans.||Participants|||Count of Participants
786355|NCT00842257|Secondary|Median Overall Survival|The duration of time from start of treatment to time of death or otherwise the date of last tumor assessment. Median survival was calculated using Kaplan Meier suvival analysis.|3 years|||Months||Full Range|Median
786356|NCT00842257|Secondary|Median Progression Free Survival (PFS)|The duration of time from start of treatment to time of radiologic disease progression per RECIST or death, or otherwise the date of last tumor assessment. Median PFS was calculated using Kaplan Meier suvival analysis. Progressive disease is defined as having at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|3 years|One patient withdrawn due to an infusion reaction prior to first re-staging CT scans.||Months||Full Range|Median
786385|NCT00842829|Secondary|Participants With Adverse Events (AE) Summarized by Treatment Period|Participants with treatment-emergent adverse events are summarized by each treatment period. Relation to study drug was assessed by the investigator. The 'Any AE' category below includes serious adverse events.|Day 1-7 (Titration Period). Day 8-15 (Treatment Period), Days 16-688 (Continuation Period)|Safety analysis set||participants|||Number
786357|NCT00842257|Primary|Response Rate of Single Agent Panitumumab Among Patients With KRAS Wild-type Colorectal Cancer Previously Treated With Cetuximab.|"The response rate of single agent panitumumab among patients with KRAS wild-type (Kirsten rat sarcoma viral oncogene homolog) colorectal cancer previously treated with cetuximab. Inclusive of three patients with clinical progression prior to first re-staging CT scans. Response rate evaluated using RECIST (Response Evaluation Criteria In Solid Tumors). Best overall response is recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started).
RECIST:
Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD (longest diameter) of target lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions"|3 years|One patient withdrawn for an infusion reaction prior to first re-staging CT scans.||Participants|||Count of Participants
786358|NCT00842335|Secondary|Days to Progression|Progression: At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum of LD recorded since the treatment started or the appearance of one or more new lesions|Up to 112 days (four 28-day cycles) or longer if the patient is benefiting from treatment|The efficacy analyses were performed using all patients, who had at least one post-treatment evaluation for tumor assessment (N=17). The overall response was based on the number of cycles of treatment before the participant experienced progressive disease.||days||Full Range|Median
786359|NCT00842335|Secondary|Overall Clinical Response by Cycle|"Stable disease: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD since the treatment started.
Progressive disease: At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum of LD recorded since the treatment started or the appearance of one or more new lesions"|Up to 112 days ( four 28-day cycles)|All 18 participants were analyzed.||participants|||Number
786360|NCT00842335|Secondary|Number of Participants Reaching Maximum Tolerated Dose|Number of participants withdrawn from study due to adverse events|Up to 112 days (up to four 28-day cycles) or longer if the patient is benefiting from treatment|Only one subject withdrew due to an adverse event.||participants|||Number
786361|NCT00842335|Primary|Maximum Tolerated Dose (MTD) of JI-101|"The primary objective of this study was to determine the maximum tolerated dose (MTD) of JI-101 when administered orally in patients with advanced solid tumors.
The MTD was established based on safety data from Cycle 1. Patients who completed 21 days of treatment in Cycle 1 were considered to have completed the study for the determination of MTD.
Patients were eligible to continue treatment with JI-101 until they experienced disease progression or unacceptable treatment-related toxicity. Unacceptable treatment-related toxicity was defined as a clinically significant AE or abnormal laboratory value assessed as unrelated to disease progression, intercurrent illness, or concomitant medications, and that was attributed to JI 101."|28 days (1 cycle)|"Full Analysis Population (FAS) or Modified Intent-to-Treat (mITT) Population: All patients enrolled into the study who received JI-101 and completed at least 21 days of dosing in Cycle 1 comprised the FAS.
Safety Population: Included all patients who received at least one dose of study drug. This population was used for all safety analyses."||mg|||Number
786362|NCT00842348|Secondary|Progression Free Survival (PFS): Kaplan-Meier Estimate|"The time from randomisation in Study 726 to the first occurrence of either disease progression (measured using Response Evaluation Criteria In Solid Tumours [RECIST] criteria) or death in Study 726 or in Study 729, or equivalently, the Progression Free Survival (PFS) time.
Tumour assessments for the placebo group after switching to open label lanreotide Autogel were excluded for the purpose of this analysis. Estimation of the median was based on the Kaplan-Meier method."|Throughout the study (every 24 weeks and at completion/withdrawal visit)|Intention-to-treat (ITT) population: all patients randomised in the original protocol Study 726 (regardless of whether they continued into the extension Study 729). The ITT population was analysed using patients as randomised in Study 726.||weeks||95% Confidence Interval|Median
786363|NCT00842348|Primary|Adverse Events|"Adverse events (AEs) that were ongoing from Study 726 at the time of entry into Study 729 were transcribed into the case report form (CRF) for Study 729 with a start date corresponding to the original report of this AE in Study 726. All new AEs that started after the last visit in Study 726 (i.e. irrespective of whether the AE had onset before or after giving informed consent for Study 729) were recorded Study 729.
An AE was considered as a treatment emergent adverse event (TEAE) for Study 729 if:
It was not present prior to receiving the first dose of study treatment in Study 729; or,
It was present prior to receiving the first dose of study treatment in Study 729 but the intensity increased after the first dose of study treatment in Study 729.
Adverse event data are presented in the AE section."|Throughout the study until the completion/early discontinuation visit.|Safety population: all patients who received at least one dose of lanreotide Autogel in Study 729.||participants with any TEAEs|||Number
786364|NCT00842361|Secondary|Systolic BP (Blood Pressure)|Values at baseline (Week 0) and at Week 6|Week 0, Week 6.|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. Missing data is imputed using last observation carried forward (LOCF).||mmHg||Standard Deviation|Mean
786365|NCT00842361|Secondary|Diastolic BP (Blood Pressure)|Values at baseline (Week 0) and at Week 6|Week 0, Week 6|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. Missing data is imputed using last observation carried forward (LOCF).||mmHg||Standard Deviation|Mean
786366|NCT00842361|Secondary|Electrocardiogram (ECG) Worsening|The number of subjects having an electrocardiogram (ECG) that changed from 'Normal' or 'Abnormal, not clinically significant' to 'Abnormal, clinically significant'. 'Abnormal, Clinically significant' is an abnormality that suggests a disease and/or organ toxicity and is of a severity, which requires active management.|Week 0, Week 6|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. Missing data is imputed using last observation carried forward (LOCF).||participants|||Number
786367|NCT00842361|Secondary|Change in Body Weight|Change from baseline in body weight after 6 weeks of treatment|Week 0, Week 6|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. Missing data is imputed using last observation carried forward (LOCF).||kg||Standard Deviation|Mean
786368|NCT00842361|Secondary|Number of Treatment Emergent Adverse Events (AEs)|Corresponds to number of adverse events. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject’s daily activities. Moderate: marked symptoms, moderate interference with subject’s daily activities. Severe: considerable interference with subject’s daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.|Week 0 to Week 6 + 5 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||events|||Number
786369|NCT00842361|Primary|Rate of Nocturnal Major and Minor Hypoglycaemic Episodes|Rate of nocturnal major and minor hypoglycaemic episodes per patient year (1year=365.25days) of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose ≤ 55 mg/dL. Episodes were defined as nocturnal if the time of onset was between 23:00 and 05:59 (both inclusive).|Week 0 to Week 6 + 5 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||Episodes /year of patient exposure|||Number
786370|NCT00842361|Primary|Rate of Major and Minor Hypoglycaemic Episodes|Rate of major and minor hypoglycaemic episodes per patient year (1year=365.25days) of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose ≤ 55 mg/dL.|Week 0 to Week 6 + 5 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||Episodes /year of patient exposure|||Number
786371|NCT00842543|Primary|Percent Change From Baseline in Beta-Carotene in Overweight and Lean Boys|Value at 6 months minus value at baseline. Beta-carotene is a component of the body’s natural defense system against every day oxidative stress. Beta-carotene concentrations were measured by reverse-phase high-performance liquid chromatography with photodiode array detection between 220-600 nm.|Baseline and 6 months|||Percent Change||Standard Error|Least Squares Mean
786372|NCT00842543|Primary|Beta-carotene Levels Between Overweight and Lean Boys at Baseline|Value at baseline. Beta-carotene is a component of the body’s natural defense system against every day oxidative stress. Beta-carotene concentrations were measured by reverse-phase high-performance liquid chromatography with photodiode array detection between 220-600 nm.|Baseline|||mM/L||Inter-Quartile Range|Median
786373|NCT00842608|Secondary|Mortality||ICU, in-hospital, 30-days post hospitalization|||Participants|||Count of Participants
786374|NCT00842608|Secondary|Hospital Length of Stay Post Randomization||Participants were followed for the duration of hospital stay, an average of 11 days|||days||Standard Deviation|Mean
786375|NCT00842608|Primary|Days Free of Delirium and Coma||Admission through day 8 of stay|||days||Standard Deviation|Mean
786376|NCT00842712|Secondary|Randomized Part: Time to Treatment Failure|Time to treatment failure was defined as the time from first administration of trial treatment until the date of the first occurrence of one of the events defining treatment failure: Progressive Disease (PD) assessed by the investigator, discontinuation of treatment due to PD, discontinuation of treatment due to an adverse event (AE), start of any new anticancer therapy, or withdrawal of consent or death within 60 days of the last tumor assessment or first administration of trial treatment. Time to treatment failure was assessed according to modified World Health Organization (WHO) criteria by Independent Review Committee (IRC).|Time from randomization until treatment failure or last tumor assessment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date,(26 Jun 2013)|ITT population included all participants who were randomized to trial treatment.||months||95% Confidence Interval|Median
786377|NCT00842712|Secondary|Randomized Part: Best Overall Response (BOR) Rate|The BOR rate is defined as the percentage of participants having achieved confirmed complete response (CR) or partial response (PR) as the best overall response, based on radiological assessments (based on response evaluation criteria in solid tumors [RECIST]) as assessed by Independent Review Committee (IRC): CR = disappearance of all target lesions; PR = at least 30% decrease in the sum of the longest diameter of target lesions.|Time from randomization until disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date,(26 Jun 2013)|ITT population included all participants who were randomized to trial treatment.||percentage of participants||95% Confidence Interval|Number
786378|NCT00842712|Secondary|Randomized Part: Overall Survival (OS) Time|The OS time is defined as the time (in months) from randomization to death or last day known to be alive. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.|Time from randomization until death or last day known to be alive, reported between day of first participant randomized, that is, Feb 2009 until cut-off date,(26 Jun 2013)|ITT population included all participants who were randomized to trial treatment.||months||95% Confidence Interval|Median
786379|NCT00842712|Secondary|Randomized Part: Progression Free Survival (PFS) Time - Investigator Read|The PFS time is defined as the duration from randomization to either first observation of progressive disease (PD) or occurrence of death due to any cause. Investigator read is the assessment of all imaging by the treating physician at the local trial site.|Time from randomization until disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date, (26 Jun 2013)|ITT population included all participants who were randomized to trial treatment.||months||95% Confidence Interval|Median
786380|NCT00842712|Primary|Randomized Part: Progression Free Survival (PFS) Time - Independent Read|The PFS time is defined as the duration from randomization to either first observation of progressive disease (PD) or occurrence of death due to any cause. Independent Read is the assessment of all imaging centrally by an Independent Review Committee (IRC).|Time from randomization until disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date, (26 Jun 2013)|Intent-to-treat (ITT) population included all participants who were randomized to trial treatment.||months||95% Confidence Interval|Median
786381|NCT00842712|Primary|Safety run-in Part: Number of Participants With Dose Limiting Toxicities (DLTs)||Up to Week 3|DLT population included all participants who completed first 3 weeks of treatment (first chemotherapy cycle) or who discontinued treatment due to any DLT during the first 3 weeks of treatment in the safety-run-in part.||participants|||Number
786386|NCT00842829|Secondary|Participant's Global Impression of Change at the End of the Treatment Period|Global impression of change was assessed using the question 'Since the start of the study, my overall status is?'. The answer was based on a 7-point scale (1=Very much improved, 2=Much improved, 3=Minimally improved, 4=No change, 5=Minimally worse, 6=Much worse, and 7=Very much worse). This assessment was performed at the end of the Treatment Period (or early termination).|approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with a response||participants|||Number
786387|NCT00842829|Secondary|Participant's Global Assessment of Ease of Use at the End of the Treatment Period|Ease of use was assessed using the question ‘Did you find this treatment easy/convenient to use for treatment of your breakthrough pain episodes?’. The answer was based on a 4-point numerical scale (0=Poor, 1=Fair, 2=Easy, 3=Very Easy). This assessment was performed at the end of the Treatment Period (or early termination).|approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with a response||participants|||Number
786388|NCT00842829|Secondary|Participant's Global Assessment of Satisfaction (Do You Understand the Instructions?) at the End of the Treatment Period|"Responses to the Patient Satisfaction questionnaire question, Do you understand the instructions?, were captured on a five-point scale from 0=not at all to 4=very much."|approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with a response||participants|||Number
786389|NCT00842829|Secondary|Participant's Global Assessment of Satisfaction (Do You Feel Safe Taking This Medication?) at the End of the Treatment Period|"Responses to the Patient Satisfaction questionnaire question, Do you feel safe taking this medication?, were captured on a five-point scale from 0=not at all to 4=very much."|approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with a response||participants|||Number
786390|NCT00842829|Secondary|Participant's Global Assessment of Satisfaction (Do You Find This Medication Comfortable to Take in Public?) at the End of the Treatment Period|"Responses to the Patient Satisfaction questionnaire question, Do you find this medication comfortable to take in public?, were captured on a five-point scale from 0=not at all to 4=very much."|approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with a response||participants|||Number
786391|NCT00842829|Secondary|Participant's Global Assessment of Satisfaction (Is This Medication Easy to Take?) at the End of the Treatment Period|"Responses to the Patient Satisfaction questionnaire question, Is this medication easy to take?, were captured on a five-point scale from 0=not at all to 4=very much."|approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with a response||participants|||Number
786392|NCT00842829|Secondary|Participant's Global Assessment of Satisfaction (Does This Medication Provide Adequate Relief?) at the End of the Treatment Period|"Responses to the Patient Satisfaction questionnaire question, Does this medication provide adequate relief?, were captured on a five-point scale from 0=not at all to 4=very much."|approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with a response||participants|||Number
786393|NCT00842829|Secondary|Participant's Global Assessment of Satisfaction (Does This Medication Work Fast?) at the End of the Treatment Period|"Responses to the Patient Satisfaction questionnaire question, Does this medication work fast?, were captured on a five-point scale from 0=not at all to 4=very much."|approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with a response||participants|||Number
786394|NCT00842829|Secondary|Participant's Global Assessment of Satisfaction (Does This BTP Medication Relieve Your Pain Quickly so You Can Get Back to Sleep?) at the End of the Treatment Period|"Responses to the Patient Satisfaction questionnaire question, Does this BTP medication relieve your pain quickly so you can get back to sleep?, were captured on a five-point scale from 0=not at all to 4=very much."|approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with a response||participants|||Number
786395|NCT00842829|Secondary|Participant's Global Assessment of Satisfaction (Satisfied With BTP Treatment?) at the End of the Treatment Period|"Responses to the Patient Satisfaction questionnaire question, Satisfied with the BTP Treatment?, were captured on a five-point scale from 0=not at all to 4=very much."|approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with a response||participants|||Number
786396|NCT00842829|Secondary|Change From Baseline to End of Treatment Period (Approximately Day 15) in the Brief Pain Inventory 7-item (BPI-7S) Questionnaire: Global Score|Participants completed the BPI-7S questionnaire to indicate their quality of life and functional status between study time points. For each subscale, the participant rated their responses from 0=Does not interfere through to 10=Completely interferes. The Global Score is the sum of the subscales (total scale is 0-70). A negative change from baseline represents an improvement.|Day 0 (baseline), approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with both baseline and Treatment Period responses||units on a scale||Standard Deviation|Mean
786397|NCT00842829|Secondary|Change From Baseline to End of Treatment Period (Approximately Day 15) in the Brief Pain Inventory 7-item (BPI-7S) Questionnaire Subscale: Enjoyment of Life|"Participants completed the BPI-7S questionnaire to indicate their quality of life and functional status between study time points. For each subscale, the participant rated their responses from 0=Does not interfere through to 10=Completely interferes. A negative change from baseline represents an improvement.
This subscale assesses enjoyment of life."|Day 0 (baseline), approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with both baseline and Treatment Period responses||units on a scale||Standard Deviation|Mean
786398|NCT00842829|Secondary|Change From Baseline to End of Treatment Period (Approximately Day 15) in the Brief Pain Inventory 7-item (BPI-7S) Questionnaire Subscale: Sleep|"Participants completed the BPI-7S questionnaire to indicate their quality of life and functional status between study time points. For each subscale, the participant rated their responses from 0=Does not interfere through to 10=Completely interferes. A negative change from baseline represents an improvement.
This subscale assesses sleep."|Day 0 (baseline), approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with both baseline and Treatment Period responses||units on a scale||Standard Deviation|Mean
786409|NCT00842946|Primary|Number of Participants in Remission (Per Structured Clinical Interview for DSM-IV Axis I Disorders (SCID))|"The SCID (First, Spitzer, Gibbon, & Williams, 1996) is an extensively utilized structured diagnostic interview based on DSM-IV criteria. Estimates of interrater reliability range from moderate to high for most Axis I disorders (e.g., Williams et al., 1992; Zanarini
& Frankenburg, 2001)."|6-weeks post-treatment|||participants|||Number
786399|NCT00842829|Secondary|Change From Baseline to End of Treatment Period (Approximately Day 15) in the Brief Pain Inventory 7-item (BPI-7S) Questionnaire Subscale: Relations With Other People|"Participants completed the BPI-7S questionnaire to indicate their quality of life and functional status between study time points. For each subscale, the participant rated their responses from 0=Does not interfere through to 10=Completely interferes. A negative change from baseline represents an improvement.
This subscale assesses relations with other people."|Day 0 (baseline), approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with both baseline and Treatment Period responses||units on a scale||Standard Deviation|Mean
786400|NCT00842829|Secondary|Change From Baseline to End of Treatment Period (Approximately Day 15) in the Brief Pain Inventory 7-item (BPI-7S) Questionnaire Subscale: Normal Work|"Participants completed the BPI-7S questionnaire to indicate their quality of life and functional status between study time points. For each subscale, the participant rated their responses from 0=Does not interfere through to 10=Completely interferes. A negative change from baseline represents an improvement.
This subscale assesses normal work."|Day 0 (baseline), approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with both baseline and Treatment Period responses||units on a scale||Standard Deviation|Mean
786401|NCT00842829|Secondary|Change From Baseline to End of Treatment Period (Approximately Day 15) in the Brief Pain Inventory 7-item (BPI-7S) Questionnaire Subscale: Walking Ability|"Participants completed the BPI-7S questionnaire to indicate their quality of life and functional status between study time points. For each subscale, the participant rated their responses from 0=Does not interfere through to 10=Completely interferes. A negative change from baseline represents an improvement.
This subscale assesses walking ability."|Day 0 (baseline), approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with both baseline and Treatment Period responses||units on a scale||Standard Deviation|Mean
786402|NCT00842829|Secondary|Change From Baseline to End of Treatment Period (Approximately Day 15) in the Brief Pain Inventory 7-item (BPI-7S) Questionnaire Subscale: Mood|"Participants completed the BPI-7S questionnaire to indicate their quality of life and functional status between study time points. For each subscale, the participant rated their responses from 0=Does not interfere through to 10=Completely interferes. A negative change from baseline represents an improvement.
This subscale assesses mood."|Day 0 (baseline), approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with both baseline and Treatment Period responses||units on a scale||Standard Deviation|Mean
786403|NCT00842829|Secondary|Change From Baseline to End of Treatment Period (Approximately Day 15) in the Brief Pain Inventory 7-item (BPI-7S) Questionnaire Subscale: General Activity|"Participants completed the BPI-7S questionnaire to indicate their quality of life and functional status between study time points. For each subscale, the participant rated their responses from 0=Does not interfere through to 10=Completely interferes. A negative change from baseline represents an improvement.
This subscale assesses general activity."|Day 0 (baseline), approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with both baseline and Treatment Period responses||units on a scale||Standard Deviation|Mean
786404|NCT00842829|Secondary|Participant Assessment of Medication Performance During the Treatment Period|Participants assessed the performance of FBT at 30 minutes and 60 minutes after dosing each episode during the treatment period. For each episode, the participant answered the question ‘How well did your study medication perform in controlling the breakthrough pain episode?’ on a 5-point Likert-type scale (poor=0, fair=1, good=2, very good=3, and excellent=4).|approximately Day 8-15|Safety analysis set of participants with a response at the time point (30 or 60 minutes) post dose.||BTP episodes|Participants||Number
786405|NCT00842829|Secondary|Breakthrough Pain (BTP) Episodes Requiring the Use of Rescue Medication During the Titration Period and the Treatment Period|The number of breakthrough pain (BTP) episodes in which the participant did not obtain effective pain relief from study medication and took a rescue medication.|Days 1 to up to Day 7 (Titration Period); approximately Day 8 up to Day 15 (Treatment Period)|Safety analysis set consisting of participants who took at least one dose of study drug during the relevant study period.||BTP episodes|Participants||Number
786406|NCT00842829|Secondary|Number of Participants Reaching An Effective Dose As Assessed by the Participant During the Titration Period|Number of participants for which an effective dose of FBT was reached as judged by each participant. The effective dose was the dose that, for 2 consecutive break-through pain (BTP) episodes, provided adequate analgesia within the first 30 minutes after administration of study drug and that minimized undesirable effects. The assessment was performed by the participant and was reported in the titration-period diary. The next BTP episode was used to confirm the effective dose, and if confirmed, the effective dose was used for all following BTP episodes.|Day 1 up to Day 7|Titration safety analysis set consisting of participants who took at least one dose of study medication.||participants|||Number
786407|NCT00842829|Secondary|Kaplan-Meier Estimates for Time to Meaningful Pain Relief As Assessed by Participants During the Treatment Period For Overall Breakthrough Pain (BTP) Episodes|Overall episode data analyzed all values of time to meaningful pain relief taken over all BTP episodes during the treatment period. If meaningful pain relief was not achieved within 60 minutes of FBT intake, or if rescue medication was taken, the event was censored. Meaningful pain relief was left to the judgment of participants, who used a stopwatch and recorded the time from treatment until pain relief in a patient diary.|approximately Day 8-15|Safety analysis set consisting of participants who received at least one dose of study drug during the Treatment Period, and who recorded the time to pain relief in the patient diary.||minutes|Participants|Inter-Quartile Range|Median
786408|NCT00842829|Primary|Percentage of Participants Reaching an Effective Fentanyl Buccal Tablet (FBT) Dose As Assessed by the Participant During the Titration Period|The effective dose was the dose that, for 2 consecutive break-through pain (BTP) episodes, provided adequate analgesia within the first 30 minutes after administration of study drug and that minimized undesirable effects. The assessment was performed by the participant and was reported in the titration-period diary. The next BTP episode was used to confirm the effective dose, and if confirmed, the effective dose was used for all following BTP episodes.|Day 1 up to Day 7|Titration safety analysis set consisting of participants who took at least one dose of study medication.||percentage of treated participants|||Number
786632|NCT00843986|Secondary|Change in Renal Function From Baseline at Hours 24, 48 and 72 as Assessed by Urine Creatinine Clearance|Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination.|Baseline, 24 Hours, 48 Hours and 72 Hours|Study was terminated – assessment of this Outcome Measure was not performed.|||||
786410|NCT00842985|Primary|CANTAB:CAmbridge Neuropsychological Test Automated Battery RVIP: Rapid Visual Information Processing|"CANTAB RVIP is one component of this computerized battery and is a measure of sustained attention with a working memory component.
This study used two subscales of the RVIP.
RVP A' ( Target sensitivity, a measure of the ability to detect sequences.) The range is from 0-1; bad to good.
RVP B'' ( Response bias, which is a measure of the tendency to respond regardless of whether a target is present.
The range is from -1 to +1 ; bad to good
The numbers represent probabilities as units on a scale."|Once for each test session (4 total).|Subjects who completed all four treatment sessions. Three of these 15 subjects were not analyzed due to validity concerns of the cognitive data for at least one of the four testing sessions.||units on a scale||Standard Deviation|Mean
786411|NCT00843024|Other Pre-specified|Mean Body Mass Index of Participants at Baseline Categorized by Age Group|The mean body mass index of participants at baseline was calculated for all participants in the 12 to 14 year and 15 to 17 year age groups. Body mass index is calculated as: weight (kilograms [kg]) divided by height (meters [m]^2).|Baseline|ITT Population||Kilograms per meters squared (kg/m^2)||Standard Deviation|Mean
786412|NCT00843024|Other Pre-specified|Mean Weight of Participants at Baseline Categorized by Age Group|The mean weight of participants at baseline was calculated for all participants in the 12 to 14 year and 15 to 17 year age groups.|Baseline|ITT Population||Kilograms (kg)||Standard Deviation|Mean
786413|NCT00843024|Other Pre-specified|Number of Participants of the Indicated Race Categorized by Age Group|The race of participants at baseline was reported for all participants in the 12 to 14 year and 15 to 17 year age groups.|Baseline|ITT Population||Participants|||Number
786414|NCT00843024|Other Pre-specified|Number of Female and Male Participants Categorized by Age Group|The gender of participants at baseline was reported for all participants in the 12 to 14 year and 15 to 17 year age groups.|Baseline|ITT Population||Participants|||Number
786415|NCT00843024|Other Pre-specified|Number of Participants Randomized to Double-blind Treatment in the Indicated Age Categories at Baseline|The number of participants receiving double-blind treatment were reported according to age.|Baseline|ITT Population||Participants|||Number
786416|NCT00843024|Other Pre-specified|Mean Age of Participants at Baseline Categorized by Age Group|The mean age of participants at baseline was calculated for all participants in the 12 to 14 year and 15 to 17 year age groups.|Baseline|ITT Population||Years||Standard Deviation|Mean
786417|NCT00843024|Secondary|Number of Participants Nausea-free at 2 Hours Post-dose|The number of participants who did not have nausea at 2 hours post dose was analzyed.|2 hours after single dose of double-blind treatment (Randomization through Week 13)|ITT Population. Participants were not included in pain-related analyses if their baseline pain was not moderate or severe, and were not included in analyses of pain or symptoms if they had no post-baseline evaluation of the relevant pain or symptom up to the time point analyzed.||participants|||Number
786418|NCT00843024|Secondary|Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points|Rescue medication was defined as an additional medication taken by participants for the treatment of migraine pain or associated symptoms within 24 hours of dosing with double-blind treatment. In addition to participants who rescued from 2 to 24 hours post-dose, inclusive, this outcome measure also included nine protocol violators who rescued < 2 hours post-treatment.|Dosing to 24 hours after single dose of double-blind treatment (Randomization through Week 13)|ITT Population. Participants were not included in pain-related analyses if their baseline pain was not moderate or severe, and were not included in analyses of pain or symptoms if they had no post-baseline evaluation of the relevant pain or symptom up to the time point analyzed.||participants|||Number
786419|NCT00843024|Secondary|Number of Participants Who Used Rescue Medication From 2 to 24 Hours Post Dose|Rescue medication was defined as an additional medication taken by participants for the treatment of migraine pain or associated symptoms within 24 hours of dosing with investigational product. Permitted rescue medications included oral naproxen sodium (maximum 15 mg/kg), oral over-the-counter pain reliever, and anti-emetics. This outcome measure included only participants who rescued from 2 to 24 hours post-dose, inclusive.|2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)|ITT Population. Participants were not included in pain-related analyses if their baseline pain was not moderate or severe, and were not included in analyses of pain or symptoms if they had no post-baseline evaluation of the relevant pain or symptom up to the time point analyzed.||participants|||Number
786420|NCT00843024|Secondary|Number of Participants Sustained Nausea-free From 2-24 Hours|Participants with sustained freedom from nausea were those with an absence of nausea from 2 to 24 hours post-dose without the use of rescue medication.|2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)|ITT Population. Participants were not included in pain-related analyses if their baseline pain was not moderate or severe, and were not included in analyses of pain or symptoms if they had no post-baseline evaluation of the relevant pain or symptom up to the time point analyzed.||participants|||Number
786421|NCT00843024|Secondary|Number of Participants Sustained Phonophobia-free From 2-24 Hours|Participants with sustained freedom from phonophobia were those with an absence of phonophobia (sensitivity to sound) from 2 to 24 hours post-dose without the use of rescue medication.|2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)|ITT Population. Participants were not included in pain-related analyses if their baseline pain was not moderate or severe, and were not included in analyses of pain or symptoms if they had no post-baseline evaluation of the relevant pain or symptom up to the time point analyzed.||participants|||Number
786422|NCT00843024|Secondary|Number of Participants Sustained Photophobia-free From 2-24 Hours|Participants with sustained freedom from photophobia were those with an absence of photophobia (sensitivity to light) from 2 to 24 hours post-dose without the use of rescue medication.|2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)|ITT Population. Participants were not included in pain-related analyses if their baseline pain was not moderate or severe, and were not included in analyses of pain or symptoms if they had no post-baseline evaluation of the relevant pain or symptom up to the time point analyzed.||participants|||Number
786573|NCT00830804|Secondary|Changes in Fasting Total Cholesterol, High-density Lipoprotein and Triglyceride at Week 24|Results report the week 24 change from week 0 (week 24 - week 0) fasting total cholesterol, high-density lipoprotein and triglyceride.|From start of study treatment through week 24|Only those participants who started study treatment and who had fasting lipid measurements at week 24 and week 0 were included in the analysis.||mg/dL||Inter-Quartile Range|Median
786423|NCT00843024|Secondary|Number of Participants Pain-free at 1 Hour Post-dose|Participants with a pain-free response at 1 hour post-dose were considered as those who had a reduction in migraine headache pain from moderate (a score of 2) or severe (a score of 3) at baseline to none (a score of 0) post-treatment, without the use of rescue medication prior to or at 1 hour post dose.|1 hour after single dose of double-blind treatment (Randomization through Week 13)|ITT Population. Participants were not included in pain-related analyses if their baseline pain was not moderate or severe, and were not included in analyses of pain or symptoms if they had no post-baseline evaluation of the relevant pain or symptom up to the time point analyzed.||participants|||Number
786424|NCT00843024|Secondary|Number of Participants Phonophobia-free at 2 Hours Post-dose|The number of participants who did not have phonophobia (sensitivity to sound) at 2 hours post dose was analzyed.|2 hours after single dose of double-blind treatment (Randomization through Week 13)|ITT Population. Participants were not included in pain-related analyses if their baseline pain was not moderate or severe, and were not included in analyses of pain or symptoms if they had no post-baseline evaluation of the relevant pain or symptom up to the time point analyzed.||participants|||Number
786425|NCT00843024|Secondary|Number of Participants Photophobia-free at 2 Hours Post-dose|The number of participants who did not have photophobia (sensitivity to light) at 2 hours post dose was analyzed.|2 hours after single dose of double-blind treatment (Randomization through Week 13)|ITT Population. Participants were not included in pain-related analyses if their baseline pain was not moderate or severe, and were not included in analyses of pain or symptoms if they had no post-baseline evaluation of the relevant pain or symptom up to the time point analyzed.||participants|||Number
786426|NCT00843024|Secondary|Number of Participants Sustained Pain-free From 2-24 Hours|Participants with sustained pain-freedom were defined as those with pain-freedom at 2 hours post-dose that was maintained up to 24 hours post-treatment without the use of rescue medication.|2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)|ITT Population. Participants were not included in pain-related analyses if their baseline pain was not moderate or severe, and were not included in analyses of pain or symptoms if they had no post-baseline evaluation of the relevant pain or symptom up to the time point analyzed.||participants|||Number
786427|NCT00843024|Primary|Number of Participants Who Were Pain Free at 2 Hours Post-dose|Participants were evaluated (self-assessment) for pain intensity by using a 4-point rating scale: 0=none, 1=mild, 2=moderate, and 3=severe. Participants with pain-free response were considered as those who had a reduction in migraine headache pain from moderate (score=2) or severe (score=3) at baseline to none (score=0) post-treatment, without the use of rescue medication (additional medication taken by participants for the treatment of migraine pain or associated symptoms) prior to or at 2 hours post-dose.|2 hours after single dose of double-blind treatment (Randomization through Week 13)|ITT Population: participants who took a dose of double-blind randomized treatment and provided some assessment of their migraine pain or associated symptoms. Participants were not included in this analysis if their baseline pain was not moderate or severe, or if they had no post-baseline evaluation of pain up to the time point analyzed.||participants|||Number
786428|NCT00843050|Secondary|Time to Progression|It is defined as the time from day 1 of the study drug administration until the first date of progressive disease.|End of study treatment|The efficacy population includes all patients who have completed at least two cycles of P276-00 therapy and have tumor measurements.||years||Standard Deviation|Mean
786429|NCT00843050|Secondary|Duration of Response|It is defined as the time from when the measurement criteria are met for complete or partial response until the first date that recurrent or progressive disease is objectively or clinically documented.|End of the study treatment|The efficacy population includes all patients who have completed at least two cycles of P276-00 therapy and have tumor measurements.||proportion of participants||Inter-Quartile Range|Median
786430|NCT00843050|Primary|Best Overall Objective Response Rate|The primary efficacy endpoint is the proportion of subjects achieving an objective response. The proportion of patients achieving an objective response is the best overall objective response rate.|End of every 2 cycles and end of the study treatment|The efficacy population includes all patients who have completed at least two cycles of P276-00 therapy and have tumor measurements.||proportion of participants||Standard Deviation|Mean
786431|NCT00843115|Secondary|Change From Baseline in Subject's Anxiety/Depression at Week 12 LOCF|"EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including anxiety/depression (none, moderate or extreme anxiety/depression). Analysis of difference between the proportion of subjects with any problem and “no problem” at baseline versus at Week 12 LOCF"|baseline, Week 12 LOCF|Intent to Treat (ITT)LOCF: All Subjects who did not have a response for post baseline assessment were not included in analysis||Participants|||Number
786432|NCT00843115|Secondary|Change From Baseline in Subject's Anxiety/Depression at Week 12|"EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including anxiety/depression(none, moderate or extreme anxiety/depression). Analysis of difference between the number of subjects with any problem and “no problem” at baseline versus at Week 12."|baseline, Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis||Participants|||Number
786433|NCT00843115|Secondary|Change From Baseline in Subject's Pain/Discomfort at Week 12 LOCF|"EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including discomfort(no pain, moderate pain, extreme pain). Analysis of difference between the proportion of subjects with any problem at baseline versus Week 12 LOCF"|Week 12 LOCF|Intent to Treat (ITT)LOCF: All Subjects who did not have a response for post baseline assessment were not included in analysis||Participants|||Number
786434|NCT00843115|Secondary|Change From Baseline in Subject's Pain/Discomfort at Week 12|"EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including discomfort(no pain, moderate pain, extreme pain). Analysis of difference between the number of subjects with any problem and “no problem” at baseline versus at Week 12."|baseline, Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis||Participants|||Number
787087|NCT00840099|Primary|Bioequivalence Based on AUC0-t for Clavulanic Acid|AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration|Blood samples collected over 14 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
786435|NCT00843115|Secondary|Change From Baseline in Subject's Usual Activities at Week 12 LOCF|"EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including usual activities (no problem, some problem, unable to perform). Analysis of difference between the number of subjects with any problem and “no problem” at baseline versus at Week 12 LOCF"|baseline, 12 Weeks LOCF|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis||Participants|||Number
786436|NCT00843115|Secondary|Change From Baseline in Subject's Usual Activities at Week 12|"EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including usual activities(no problem, some problem, unable to perform). Analysis of difference between the number of subjects with any problem and “no problem” at baseline versus at Week 12."|baseline, Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis||Participants|||Number
786437|NCT00843115|Secondary|Change From Baseline in Subject's Self-Care at Week 12 LOCF|"EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including self-care (no problem, some problems, unable to wash or dress). Analysis of difference between the number of subjects with any problem and “no problem” at baseline versus at Week 12 LOCF."|baseline, 12 Weeks LOCF|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis||Participants|||Number
786438|NCT00843115|Secondary|Change From Baseline in Subject's Self-Care at Week 12|"EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including self-care (no problem, some problems, unable to wash or dress). Analysis of difference between the number of subjects with any problem and no problem at baseline versus at Week 12"|baseline, Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis||participants|||Number
786439|NCT00843115|Secondary|Change From Baseline in Subject's Mobility at Week 12 LOCF|"EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including mobility (no problem walking, some problems walking, confined to bed). Analysis of difference between the proportion of subjects with any problem at baseline versus Week 12 LOCF"|Week 12 LOCF|Intent to Treat (ITT) LOCF: All Subjects who did not have a response for post baseline assessment were not included in analysis||Participants|||Number
786440|NCT00843115|Secondary|Change From Baseline in Subject's Mobility at Week 12|"EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including mobility (no problem walking, some problems walking, confined to bed). Analysis of difference between the number of subjects with any problem and no problem at baseline versus at Week 12."|baseline, 12 Weeks|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis||participants|||Number
786441|NCT00843115|Secondary|LOCF Change From Baseline in Visual Analog Scale (VAS) of Subject's Overall Health Included in EuroQuality of Life-5 Domains (EQoL-5D) Questionnaire|EuroQuality of Life-5 Domains (EQoL-5D) Questionnaire includes a visual analogue scale (VAS) of subject's overall health with 0 (worst state) to 100 (best state). Change: mean score at Week 12 minus mean score at baseline.|baseline, 12 Weeks LOCF|Intent to Treat (ITT)LOCF: (n=318; number of subjects responding).||score on scale||Standard Deviation|Mean
786442|NCT00843115|Secondary|Change From Baseline in Visual Analog Scale (VAS) of Subject's Overall Health Included in EuroQuality of Life-5 Domains (EQoL-5D)Questionnaire|EuroQuality of Life-5 Domains (EQoL-5D)Questionnaire includes a visual analogue scale (VAS) of subject's overall health with 0 (worst state) to 100 (best state). Change: mean score at Week 12 minus mean score at baseline.|baseline, 12 Weeks|Intent to Treat (ITT): (n=286; number of subjects responding).||score on scale||Standard Deviation|Mean
786443|NCT00843115|Secondary|LOCF Change From Baseline Total Score in EuroQuality of Life-5 Domains (EQoL-5D)|EQoL-5D: measures index of health & defines it in 5 Domains: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each evaluated on 3-point scale yielding 243 potential combinations converted to utility values ranging from -0.59(worst state) to 1 (perfect state). Change:Week 12 mean score minus baseline mean score|baseline, 12 Weeks LOCF|Intent to Treat (ITT) LOCF: (n=321; number of subjects responding)||score on scale||Standard Deviation|Mean
786444|NCT00843115|Secondary|Change From Baseline Total Score in EuroQuality of Life-5 Domains (EQoL-5D)|EQoL-5D: measures index of health and defines it in 5 Domains:mobility,self-care,usual activities, pain/discomfort, anxiety/depression. Each domain evaluated on 3-point scale yielding 243 potential combinations; converted to utility values ranging from -0.59(worst state) to 1 (perfect state). Change: Week 12 mean score minus baseline mean score|baseline, 12 Weeks|Intent to Treat (ITT) (n=290; number of subjects responding)||score on scale||Standard Deviation|Mean
786445|NCT00843115|Secondary|Correlation Analysis: LOCF Change From Baseline in Combined Patient and Caregiver Quality of Life in Alzheimer's Disease (QoL-AD) Questionnaire Total Score Versus the Number of Treatment Emergent Adverse Events (TEAEs)|QoL- AD: physical health, energy, mood, living situation, memory, family, marriage, friends, chores, fun, money, self, and life as a whole. Likert scale, 1 (poor) - 4 (excellent), possible total 13 to 52. Ratings from patient and the caregiver combined and correlated with number of treatment emergent adverse events.|baseline, 12 Weeks LOCF|Intent to Treat (ITT) LOCF: (n=231; number of patients responding)||Pearson Product Correlation Coefficient|||Number
786446|NCT00843115|Secondary|Correlation Analysis: Change From Baseline in Combined Patient and Caregiver Quality of Life in Alzheimer's Disease(QoL-AD) Questionnaire Total Score Versus Number of Treatment Emergent Adverse Events (TEAEs)|QoL- AD: physical health, energy, mood, living situation, memory, family, marriage, friends, chores, fun, money, self, and life as a whole. Likert scale, 1 (poor) - 4 (excellent), possible total 13 to 52. Patient and the caregiver totals combined and correlated to number of treatment emergent adverse events.|baseline, 12 Weeks|Intent to Treat (ITT). (n=207 number of subjects responding)||Pearson Product Correlation Coefficient|||Number
786485|NCT00843284|Primary|Daily Average Pain Scores|Change is observed value at final visit (Week 8 or discontinuation) minus baseline value. Daily average pain score is measured using a 10-point Likert scale where 0 = no pain to 10 = pain as bad as you can imagine.|Baseline, Final Visit (Week 8 or discontinuation)|Full analysis set (FAS). Full analysis set was derived from the set of all enrolled subjects who were administered the study medication and had post baseline documentation of efficacy. Last observation carried forward (LOCF) method was used.||scores on scale||Standard Deviation|Mean
786447|NCT00843115|Secondary|LOCF Change From Baseline in Combined Patient and Caregiver Health Related Quality of Life (Alzheimer's Disease) (HR QoL-AD) Questionnaire Total Scores|Hr QoL- AD: physical health, energy, mood, living situation, memory, family, marriage, friends, chores, fun, money, self, and life as a whole. Likert scale, 1 (poor) - 4 (excellent), possible total 13 to 52. Separate ratings from both the patient and the caregiver. Change: mean score at Week 12 minus mean score at baseline.|baseline, 12 Week LOCF|Intent to Treat (ITT)LOCF: (n=231; number of subjects responding)||score on scale||Standard Deviation|Mean
786448|NCT00843115|Secondary|Change From Baseline in Combined Patient and Caregiver Health Related Quality of Life (Alzheimer's Disease) (HR QoL-AD) Questionnaire Total Scores|Hr QoL- AD: physical health, energy, mood, living situation, memory, family, marriage, friends, chores, fun, money, self, and life as a whole. Likert scale, 1 (poor) - 4 (excellent), possible total 13 to 52. Separate ratings from both the patient and the caregiver. Change: mean score at Week 12 minus mean score at baseline.|baseline, 12 Weeks|Intent to Treat (ITT). (n= 207; number of subjects who responded)||score on scale||Standard Deviation|Mean
786449|NCT00843115|Secondary|Correlation Between LOCF Change From Baseline in Mini-Mental State Examination (MMSE) Score and LOCF Change From Baseline in Combined Patient and Caregiver Health Related Quality of Life (Alzheimer's Disease) (HR QoL-AD) Questionnaire Total Score|MMSE cognitive function. Total 0 - 30, higher score, better cognitive state. Hr QoL- AD: physical health, energy, mood, living situation, memory, family, marriage, friends, chores, fun, money, self, and life as a whole. Likert scale, 1 (poor) - 4 (excellent), possible total 13 to 52. Separate ratings from both the patient and the caregiver|baseline, Week 12 LOCF|Intent to Treat (ITT) LOCF: (n=231; number of subjects responding).||Pearson Product Correlation Coefficient|||Number
786450|NCT00843115|Secondary|Correlation Between Change From Baseline in Mini-Mental State Examination (MMSE) Score and Change From Baseline in Combined Patient and Caregiver Health Related Quality of Life (Alzheimer's Disease) (HR QoL-AD) Questionnaire Total Score|MMSE cognitive function: Total 0 - 30, higher score, better cognitive state. Hr QoL- AD: physical health, energy, mood, living situation, memory, family, marriage, friends, chores, fun, money, self, and life as a whole using scale: 1 (poor) - 4 (excellent), possible total 13 - 52. Separate ratings from both patient and caregiver.|baseline, 12 Weeks|Intent to Treat (ITT); n=207 (number of subjects who responded)||Pearson Product Correlation Coefficient|||Number
786451|NCT00843115|Secondary|Last Observation Carried Forward (LOCF) Change From Baseline in Mini-Mental State Examination (MMSE) Total Scores at Week 12|MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranges from 0 - 30, higher score indicates better cognitive state. Change: mean score at Week 12 minus mean score at baseline|baseline, Week 12 LOCF|Intent to Treat (ITT) LOCF: (n=318; number of subjects responding)||score on scale||Standard Deviation|Mean
786452|NCT00843115|Secondary|Change From Baseline in Mini-Mental State Examination (MMSE) Total Scores at Week 12|MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranges from 0 - 30, higher score indicates better cognitive state. Change: mean score at Week 12 minus mean score at baseline.|baseline, Week 12|Intent to Treat (ITT): (n=288; number of subjects responding)||score on scale||Standard Deviation|Mean
786453|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Severity in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Severity symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis||participants|||Number
786454|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Caregiver in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Caregiver symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis||participants|||Number
786455|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Apathy in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Apathy symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis||participants|||Number
786456|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Delusions in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Delusions symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis||participants|||Number
786457|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Anxiety in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Anxiety symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis||participants|||Number
786458|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Mood in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Mood symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis||participants|||Number
786459|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Agitation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Agitation symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis||participants|||Number
786460|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Telephoning in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Telephoning symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis||participants|||Number
786461|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Dressing in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Dressing symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis||participants|||Number
786462|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Hygiene in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Hygiene symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis||participants|||Number
786463|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Domestic Activities in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Domestic Activities symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis||participants|||Number
786464|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Leisure in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Leisure symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis||participants|||Number
786465|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Insight in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Insight symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis||participants|||Number
786466|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Judgment in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Judgment symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis||participants|||Number
786467|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Spatial Orientation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Spatial Orientation symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to categories: Improved/Stabilized=4,5,6; Worsened=2,3|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis||participants|||Number
786468|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Asphasia in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Asphasia symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded toCategories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis||participants|||Number
786469|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Temporal Orientation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Temporal Orientation symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis||Participants|||Number
786470|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Remembering in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Remembering symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded toCategories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis||participants|||Number
786471|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Repetitiveness in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Repetitiveness symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis||Participants|||Number
786472|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Attention in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Attention symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline and Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT) : All subjects who did not have a response for post baseline assessment were not included in analysis.||Participants|||Number
786473|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Cognitive Activation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Cognitive Activation symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis.||participants|||Number
786474|NCT00843167|Secondary|Treatment Compliance|For treatment compliance, participants who take >=80% of the prescribed pills will be considered to be treatment-compliant.|Baseline and end of study (up to 8 weeks)|||participants|||Number
786475|NCT00843167|Primary|Change in Histone Deacetylase (HDAC) Activity as Assessed in Peripheral Blood Mononuclear Cells (PBMC) at Baseline and After Completion of Study Therapy|PBMC HDAC activity was evaluated using the positive control, sodium butyrate.HDAC activity is expressed relative to PBMC protein content and negative control.|Baseline and End of Study (up to 8 weeks)|PBMCs available pre-/post-intervention.||pmol/min/mg protein||Standard Error|Mean
786476|NCT00843167|Primary|Change in Ki-67 as Assessed at Baseline and After Completion of Study Therapy|Ki-67 was measured through immunohistochemistry method. A modified H-score was recorded, which involved semi-quantitative assessment of both staining intensity (graded as 1-3 with 1 representing weak staining, 2 moderate staining, and 3 strong staining) and percentage of positive cells. The range of the H-score was 0-300. The maximum score indicates the strongest expression, the minimum score indicates no expression of positive tumor area.|Baseline and end of study (up to 8 weeks)|Maximum two observations (pre- and post- treatments) were expected per participant. Linear mixed effect models were used to calculate adjusted least square means (LSMEANS) and 95% confidence intervals,& to test the statistical significance of the difference between pre- and post- treatments within each group, as well as between treatment groups.||Log 2 (H-score)||95% Confidence Interval|Least Squares Mean
786477|NCT00843167|Primary|Change in Isothiocyanate in Urine Samples as Assessed at Baseline and After Completion of Study Therapy|Isothiocyante including sulforaphane in micromolar (µM) concentration was measured following standard chemical measurement procedures and divided by the creatinine values in millimolar (mM) concentration.|Baseline and end of study (up to 8 weeks)|||µM/mM creatinine||Standard Error|Mean
786478|NCT00843180|Secondary|Days to Recovery Neutrophil Count|number of days to recovery neutrophil count >500 cells per microliter for 2 consecutive days (range, up to 100 days, censored at 100 days)|hospital stay|||number of days||95% Confidence Interval|Mean
786479|NCT00843180|Secondary|Days of Hospital Stay|days of hospital stay after bone marrow transplant (up to 100 days; participant observation was censored after 100 days)|days of hospital stay after bone marrow transplant|ITT||number of days||95% Confidence Interval|Mean
786480|NCT00843180|Secondary|Number of Vomiting Episodes|number of vomiting episodes as reported by nurses per occurence (no upper limit)|day -7 to +21 around transplant date|ITT||number of episodes||95% Confidence Interval|Mean
786481|NCT00843180|Primary|Number of Days With Pain Scores >3 Measured on Numeric Rating Scale (Range 0-10; 0 for no Pain; 10 for Worst Pain Imaginable)|days of pain >3 by nurses notes based on pain scores on numeric rating scale (up to 28 days)|7 days pre to 21 days post transplant = 28 days|ITT no imputations||days||95% Confidence Interval|Mean
786482|NCT00843284|Secondary|Patient Global Improvement of Change (PGIC) at Final Visit (Week 8 or Discontinuation)|"Patient Global Improvement of Change (PGIC) indicates the change of severity of conditions from baseline, graded from very much improved to very much worse."|Final Visit (Week 8 or discontinuation)|Full analysis set (FAS). Full analysis set was derived from the set of all enrolled subjects who were administered the study medication and had post baseline documentation of efficacy. Last observation carried forward (LOCF) method was used.||participants|||Number
786483|NCT00843284|Secondary|Clinician Global Improvement of Change (CGIC) at Final Visit (Week 8 or Discontinuation)|"Clinician Global Improvement of Change (CGIC) indicates the change of the severity of the condition from baseline, graded from very much improved to very much worse."|Final Visit (Week 8 or discontinuation)|Full analysis set (FAS). Full analysis set was derived from the set of all enrolled subjects who were administered the study medication and had post baseline documentation of efficacy. Last observation carried forward (LOCF) method was used. Three subjects were not included in the analysis due to incomplete case report forms.||participants|||Number
786484|NCT00843284|Primary|Pain Related Sleep Interference|Change is observed value at final visit (Week 8 or discontinuation) minus baseline value. Pain related sleep interference is measured by a 10-point Likert scale where 0 = does not interfere with sleep, and 10 = completely interferes with sleep|Baseline, Final Visit (Week 8 or discontinuation)|Full analysis set (FAS) was derived from the set of all enrolled subjects who were administered the study medication and had post baseline documentation of efficacy. Last observation carried forward (LOCF) method was used.||scores on a scale||Standard Deviation|Mean
786518|NCT00843778|Secondary|Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 8|The ISRQ is scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Scores range from 0 to 10. Subjects receiving hospital nurse injection at this visit completed the ISRQ questionnaire.|Week 8|Of the 130 subjects in the Full Analysis Set, 34 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.||units on a scale||Standard Deviation|Mean
786486|NCT00843284|Secondary|Anxiety and Depression Symptoms|The presence of anxiety and depression symptoms were measured, based on how often the subject felt a certain emotion over the past week. Q1:Have you felt calm and relaxed? Q2: Have you felt full of energy? Q3: Have you felt discouraged and sad? Final Visit = Week 8 or time of discontinuation.|Baseline, Final Visit (Week 8 or discontinuation)|Full analysis set (FAS). Full analysis set was derived from the set of all enrolled subjects who were administered the study medication and had post baseline documentation of efficacy. Last observation carried forward method (LOCF) was used.||participants|||Number
786487|NCT00843310|Primary|Toxicity, Time to Progression & Progression Free Survival|"Toxicity will be scored using CTCAE version 3.0 for toxicity and adverse event reporting.
Progressive Disease: requires any one or more of the following:
Increase of ≥25% from baseline in Serum M-component and/or (the absolute increase must be ≥0.5 g/dl)b
Urine M-component and/or (the absolute increase must be ≥200 mg/24 h
Only in patients without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels. The absolute increase must be >10 mg/dl.
Bone marrow plasma cell percentage: the absolute % must be ≥10%c
Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas
Development of hypercalcemia (corrected serum calcium >11.5 mg/dl or 2.65 mmol/l) that can be attributed solely to the plasma cell proliferative disorder"|every 28 days during therapy and every month after therapy for 2 years|No data are available because data were not collected. Pi left the institution and slow accrual did not allow for sufficient data collection prior to PI leaving institution. No data were analyzed.|||||
786488|NCT00843349|Primary|Percentage Changes in Parathyroid Hormone (PTH) Levels|Nonfasting blood was assessed over a period of 12 weeks. Endpoint was percentage changes in PTH levels from baseline.|Week 0 - 12|All participants that completed their respective intervention periods were selected for analysis.||percentage of change from baseline||Standard Deviation|Mean
786489|NCT00843349|Primary|Percentage Changes in Fibroblast Growth Factor-23 (FGF-23) Levels|Nonfasting blood was assessed over a period of 12 weeks. The primary endpoint was percentage change in FGF-23 levels from baseline.|Week 0 - 12|All participants that completed their respective intervention periods were selected for analysis.||percentage of change from baseline||Standard Deviation|Mean
786490|NCT00843466|Primary|Investigator Global Assessment|Changes in global disease severity on a scale from 0-4 with 0 being clear and 4 being severe|Wk 4|||units on a scale||95% Confidence Interval|Mean
786491|NCT00843479|Secondary|GLP-1 Area Under the Curve (AUC)|Area under the curve of glucagon-like peptide (GLP-1) concentrations (measured by ELISA kit) from time 0 to 180 min during a standard meal tolerance test, calculated by the trapezoidal rule.|1 month from screening visit|||pg/ml/min||Standard Deviation|Mean
786492|NCT00843479|Secondary|Serum Dipeptidyl Peptidase IV (DPP-IV) Concentration|measured in fasting serum sample by ELISA kit|within 1 month from screening visit|||pg/ml||Standard Deviation|Mean
786493|NCT00843479|Primary|Distinctive Beta-cell Function From the Arginine Stimulation Test in Normoglycemic Subjects After Sixty-five Years Old in Comparison With Middle-age Normoglycemic Subjects.|Distinctive beta-cell function as measured by the disposition index - based on the acute insulin response from the arginine stimulation test versus glucose infusion rate adjusted by free fat mass from hyperglycemic clamp - in normoglycemic subjects after sixty-five years old in comparison with middle-age normoglycemic subjects.|within 1 month from screening visit|||(μmol∙kg-1.min-1)||Standard Error|Mean
786494|NCT00843479|Primary|Adaptive Beta-cell Insulin Production. The Product of Meal Tolerance Test-derived Insulinogenic Index (IGI) for Clamp-derived Insulin Sensitivity Index (ISI) in Normoglycemic Subjects After 65 Years Old in Comparison With Middle-age Normoglycemic Subjects|Beta-cell function was determinated as the beta-cell secretion measured by meal tolerance test adjusted by insulin sensitivity assessed by the hyperglycemic clamp test:Insulinogenic Index/Insulin Sensitivity Index adjusted by free fat mass|within 1 month from screening visit|||(μmol∙kg-1min-1)||Standard Deviation|Mean
786495|NCT00843479|Primary|Glucose Infusion Rate|Whole-body insulin sensitivity, as estimated by the mean glucose infusion rate corrected for fat-free mass(FFM){mg*[kg(FFM)^-1]*min*10} at last 60 min of 180-min hyperglycemic clamp|within 1 month from screening visit|||mg*[kg(FFM)^-1]*min*10||Standard Deviation|Mean
786496|NCT00843479|Primary|Homeostasis Model Assessment Insulin Resistance (HOMA-IR) Index|Insulin sensitivity index calculated as HOMA-IR = (Glucose * Insulin) / 22.5, where glucose is mmol/L and insulin is mili-units (mU)/L. Higher values indicate lower insulin sensitivity.|within 1 month from screening visit|minimum number required to find a significant difference between groups considering the intra-subject variation||units on a scale||Standard Deviation|Mean
786497|NCT00843492|Secondary|Participants With Any Incidence of Any Bleeding Event as Adjudicated by a CAC) From Day 1 to Complete Mobilization and From Day 1 up to the Final Visit or Contact|All episodes of bleeding, except minor bruising, skin hematomas not greater than 5 centimeters in diameter, self-limited epistaxis (bleeding through the nose), and self-limited gingival (gum) bleeding, were adjudicated by an independent CAC. The committee members were unaware of the participants' treatment assignment.|Day 1 to complete mobilization plus 4 days (average of 37.7 study days); Day 1 up to final visit or contact (average of 66.3 study days)|As-Treated Population||participants|||Number
786498|NCT00843492|Secondary|Number of Participants With Minor Bleeding From Day 1 to Complete Mobilization and From Day 1 up to the Final Visit or Contact|Minor bleeding is defined as clinically overt bleeding events that do not meet the criteria for major or clinically relevant non-major bleeding. All episodes of bleeding were adjudicated by an independent CAC. The committee members were unaware of the participants' treatment assignment.|Day 1 to complete mobilization plus 4 days (average of 37.7 study days); Day 1 up to final visit or contact (average of 66.3 study days)|As-Treated Population||participants|||Number
786499|NCT00843492|Secondary|Number of Participants With Clinically Relevant Non-major Bleeding From Day 1 to Complete Mobilization and From Day 1 up to the Final Visit or Contact|Clinically relevant non-major bleeding that does not qualify as major is defined as bleeding leading to treatment discontinuation, and/or epistaxis (bleeding through the nose) that lasts for more than 5 minutes or necessitates intervention (e.g., packing), spontaneous macroscopic haematuria (blood in urine), gastrointestinal haemorrhage, haemoptysis (coughing up blood), or subcutaneous haematoma (localized collection of blood) > 100 centimeters squared. All episodes of bleeding were adjudicated by an independent CAC. The committee members were unaware of the participants' treatment assignment.|Day 1 to complete mobilization plus 4 days (average of 37.7 study days); Day 1 up to final visit or contact (average of 66.3 study days)|As-Treated Population||participants|||Number
786500|NCT00843492|Secondary|Number of Participants With Major Bleeding From Day 1 to Complete Mobilization and From Day 1 up to the Final Visit or Contact|Major bleeding is defined as bleeding that results in a fatality, symptomatic bleeding in a critical area or organ, bleeding causing a fall in hemoglobin level of 20 grams/liter (1.24 millimoles/liter) or more compared with the pre-randomization hemoglobin level, or bleeding that leads to a transfusion of two or more units of whole blood or red blood cells. All episodes of bleeding were adjudicated by an independent CAC. The committee members were unaware of the participants' treatment assignment.|Day 1 to complete mobilization plus 4 days (average of 37.7 study days); Day 1 up to final visit or contact (average of 66.3 study days)|As-Treated Population: all participants who received at least one dose of study treatment||participants|||Number
786501|NCT00843492|Secondary|Number of Participants With Confirmed VTE and Death up to the Final Visit or Contact|The number of participants with VTE (defined as asymptomatic deep vein thrombosis [DVT: the formation of a blood clot in a deep vein] detected by systematic compression ultrasonography, symptomatic DVT, or symptomatic fatal or non-fatal pulmonary embolism [PE]) and death was assessed. An embolism is a clot in the blood that forms and blocks a blood vessel. A PE is a blood clot that has travelled from elsewhere in the body through the blood stream to block the main artery of the lung or one of its branches.|Day 1 to 5 weeks (plus or minus 1 week) after complete mobilization (average of 67.8 study days)|ITT Population||participants|||Number
786502|NCT00843492|Secondary|Number of Participants With Any Adjudicated Components of VTE, Asymptomatic DVT, Symptomatic DVT, Symptomatic PE, and Death|All components of the primary endpoint were considered separately: any VTE; symptomatic (providing no evidence of disease existence) DVT (the formation of a blood clot in a deep vein) detected by systematic compression ultrasonography; symptomatic(providing evidence of disease existence) DVT; symptomatic PE (blood clot that has travelled from elsewhere in the body through the blood stream to block the main artery of the lung of one of its branches); and death.|Day 1 to complete mobilization plus 2 days (average of 35.7 study days)|ITT Population. Only those participants contributing data at the indicated time points were analyzed.||participants|||Number
786503|NCT00843492|Primary|Number of Participants With Venous Thromboembolism (VTE) or Death up to the Time of Complete Mobilization|VTE is defined as asymptomatic deep vein thrombosis (DVT: the formation of a blood clot in a deep vein) detected by systematic compression ultrasonography, symptomatic DVT, or symptomatic fatal or non-fatal pulmonary embolism (PE). An embolism is a clot in the blood that forms and blocks a blood vessel. A pulmonary embolism is a blood clot that has travelled from elsewhere in the body through the blood stream to block the main artery of the lung or one of its branches. All venous thromboembolic events and deaths were adjudicated by the independent Central Adjudication Committee (CAC).|Day 1 to complete mobilization plus 2 days (average of 35.9 study days)|Intent-to-Treat (ITT) Population: all randomized participants with a VTE status or experiencing death. Participants without evaluation of the primary endpoint in the timeframe requested by the protocol were considered as missing data and therefore not included in the primary efficacy analysis.||participants|||Number
786504|NCT00843622|Secondary|Continuous Smoking Cessation|Continuous cessation according to self-report and CO in exhaled air of 8 ppm or less att all clinical visits|6-16 weeks||||||
786505|NCT00843622|Secondary|Point Prevalence Smoking Cessation|7-day point prevalence smoking cessation verified by CO in exhaled air of 8 ppm or less|6, 16, 28 weeks||||||
786506|NCT00843622|Secondary|Biomarkers||Baseline, week 6, 16, and 28||||||
786507|NCT00843622|Secondary|Fagerström Test for Nicotine Dependence||Baseline, week 16 and 28||||||
786508|NCT00843622|Secondary|Minnesota Nicotine Withdrawal Scale||Baseline, week 6, 10, 16 and 28||||||
786509|NCT00843622|Primary|Continuous Rate of Smoking Cessation by Self-report and Confirmed by Expired Air Carbon Monoxide Less or Equal Than 8 Ppm||Week 6-28|||participants|||Number
786510|NCT00843635|Secondary|Number of Participants Experiencing Adverse Events|Assessment of Treatment-related Side Effects. Number of participants experiencing adverse events|From Day 1 to Day 20|||participants|||Number
786511|NCT00843635|Secondary|Optimal Dosing Schedule for Tadalafil||Baseline, End of Treatment at Time of Surgery.|Optimal dosing schedule of Tadalafil not determined due to no proven superiority of one dosing arm over the other.|||||
786512|NCT00843635|Primary|Ratio of Tumor-specific T-cell Concentration in the Blood|Ratio of the number of tumor specific T cells in the blood, per treatment group, from Baseline to End of Treatment at Time of Surgery.|Baseline, End of Treatment at Time of Surgery|Data for 31 patients were analyzed.||ratio from baseline||Inter-Quartile Range|Median
786513|NCT00843635|Primary|Ratio of T-reg Cell Concentration in the Blood|Ratio of the number of regulatory T cells in the blood, per treatment group, from Baseline to End of Treatment at Time of Surgery..|Baseline, End of Treatment at Time of Surgery|||ratio from baseline||Inter-Quartile Range|Median
786514|NCT00843635|Primary|Ratio of MDSC Concentration in the Blood|Ratio of the number of Myeloid Derived Suppressor Cells (MDSC) in the Blood, per treatment group, from Baseline to End of Treatment at Time of Surgery.|Baseline, End of Treatment at time of Surgery|||ratio from baseline||Inter-Quartile Range|Median
786515|NCT00843713|Primary|Endothelial Function Measured by Brachial Artery Flow-mediated Dilation(FMD)|Measurements in the change of brachial artery diameter from pre and post treatment.|24 weeks|||millimeters||Inter-Quartile Range|Median
786516|NCT00843778|Secondary|Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 12|The ISRQ is scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Scores range from 0 to 10. Subjects receiving hospital nurse injection at this visit completed the ISRQ questionnaire.|Week 12|Of the 130 subjects in the Full Analysis Set, 37 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.||units on a scale||Standard Deviation|Mean
786517|NCT00843778|Secondary|Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 10|The ISRQ is scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Scores range from 0 to 10. Subjects receiving hospital nurse injection at this visit completed the ISRQ questionnaire.|Week 10|Of the 130 subjects in the Full Analysis Set, 37 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.||units on a scale||Standard Deviation|Mean
787131|NCT00840866|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
786519|NCT00843778|Secondary|Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 6|The ISRQ is scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Scores range from 0 to 10. Subjects receiving hospital nurse injection at this visit completed the ISRQ questionnaire.|Week 6|Of the 130 subjects in the Full Analysis Set, 36 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.||units on a scale||Standard Deviation|Mean
786520|NCT00843778|Secondary|Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 4|The ISRQ is scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Scores range from 0 to 10. Subjects receiving hospital nurse injection at this visit completed the ISRQ questionnaire.|Week 4|Of the 130 subjects in the Full Analysis Set, 35 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.||units on a scale||Standard Deviation|Mean
786521|NCT00843778|Secondary|Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 2|The ISRQ is scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Scores range from 0 to 10. Subjects receiving hospital nurse injection at this visit completed the ISRQ questionnaire.|Week 2|Of the 130 subjects in the Full Analysis Set, 36 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.||units on a scale||Standard Deviation|Mean
786522|NCT00843778|Secondary|Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 0|The ISRQ is scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Scores range from 0 to 10. Subjects receiving hospital nurse injection at this visit completed the ISRQ questionnaire.|Week 0|Of the 130 subjects in the Full Analysis Set, 31 subjects are included in the analysis of this outcome measure, based upon the number of subjects receiving hospital nurse injection at this visit, with an available assessment score at the visit.||units on a scale||Standard Deviation|Mean
786523|NCT00843778|Secondary|Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 12|The six domains of the POST SIAQ are feelings about injections, self-image, self-confidence, injection-site reactions, ease of use, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit.|Week 12|Of the 130 subjects in the Full Analysis Set, 74 or 75 subjects are included in the analysis of each subscale measure, based upon the number of subjects self-injecting at the visit, with the available subscale score at the visit. For each subscale of the questionnaire, N, Mean and SD are presented for non-missing values.||units on a scale||Standard Deviation|Mean
786524|NCT00843778|Secondary|Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 10|The six domains of the POST SIAQ are feelings about injections, self-image, self-confidence, injection-site reactions, ease of use, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit.|Week 10|Of the 130 subjects in the Full Analysis Set, 72, 73 or 74 subjects are included in the analysis of each subscale measure, based upon the number of subjects self-injecting at the visit, with the available subscale score at the visit. For each subscale of the questionnaire, N, Mean and SD are presented for non-missing values.||units on a scale||Standard Deviation|Mean
786525|NCT00843778|Secondary|Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 8|The six domains of the POST SIAQ are feelings about injections, self-image, self-confidence, injection-site reactions, ease of use, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit.|Week 8|Of the 130 subjects in the Full Analysis Set, 78, 79 or 80 subjects are included in the analysis of each subscale measure, based upon the number of subjects self-injecting at the visit, with the available subscale score at the visit. For each subscale of the questionnaire, N, Mean and SD are presented for non-missing values.||units on a scale||Standard Deviation|Mean
786526|NCT00843778|Secondary|Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 6|The six domains of the POST SIAQ are feelings about injections, self-image, self-confidence, injection-site reactions, ease of use, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit.|Week 6|Of the 130 subjects in the Full Analysis Set, 66, 67 or 68 subjects are included in the analysis of each subscale measure, based upon the number of subjects self-injecting at the visit, with the available subscale score at the visit. For each subscale of the questionnaire, N, Mean and SD are presented for non-missing values.||units on a scale||Standard Deviation|Mean
786527|NCT00843778|Secondary|Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 4|The six domains of the POST SIAQ are feelings about injections, self-image, self-confidence, injection-site reactions, ease of use, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit.|Week 4|Of the 130 subjects in the Full Analysis Set, 82 or 83 subjects are included in the analysis of each subscale measure, based upon the number of subjects self-injecting at the visit, with the available subscale score at the visit. For each subscale of the questionnaire, N, Mean and SD are presented for non-missing values.||units on a scale||Standard Deviation|Mean
786547|NCT00830791|Secondary|Plasma Glucose Concentration After Administration of a Single Oral Dose of 20 mg of MK-0941 to Participants With Moderate Renal Insufficiency Versus Matched Controls|The glucose concentration-time profile was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Moderate renal insufficiency was defined as a 24-hour CLCR of 30 to < 50 mL/min/1.73m^2.|Up to 12 Hours Post-Dose|This study was discontinued early and this evaluation was not conducted.|||||
786528|NCT00843778|Secondary|Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 2|The six domains of the POST SIAQ are feelings about injections, self-image, self-confidence, injection-site reactions, ease of use, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit.|Week 2|Of the 130 subjects in the Full Analysis Set, 80 or 81subjects are included in the analysis of each subscale measure, based upon the number of subjects self-injecting at the visit, with the available subscale score at the visit. For each subscale of the questionnaire, N, Mean and SD are presented for non-missing values.||units on a scale||Standard Deviation|Mean
786529|NCT00843778|Secondary|Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 0|The six domains of the POST SIAQ are feelings about injections, self-image, self-confidence, injection-site reactions, ease of use, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit.|Week 0 of this study (C87080 [NCT00843778])|Of the 130 subjects in the Full Analysis Set, 65 or 66 subjects are included in the analysis of each subscale measure, based upon the number of subjects self-injecting at the visit, with the available subscale score at the visit. For each subscale of the questionnaire, N, Mean and SD are presented for non-missing values.||units on a scale||Standard Deviation|Mean
786530|NCT00843778|Secondary|Mean PRE-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 0|The three domains of the PRE SIAQ are feelings about injections, self-confidence, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10. Subjects self-injecting completed this pre-self-injection questionnaire. The PRE-SIAQ is taken before the subject's first injection.|Week 0 of this study (C87080 [NCT00843778])|Of the 130 subjects in the Full Analysis Set, 66 subjects are included in the analysis of each subscale measure, based upon the number of subjects self-injecting at the visit, with the available subscale score at the visit. For each subscale of the questionnaire, N, Mean and SD are presented for non-missing values.||units on a scale||Standard Deviation|Mean
786531|NCT00843778|Secondary|Percentage of Subjects Willing to Self-inject at Week 0|The percentage of subjects willing to self-inject at Week 0 will be presented using the Full Analysis Set.|Week 0 of this study (C87080 [NCT00843778])|Full Analysis Set||percentage of participants|||Number
786532|NCT00843778|Secondary|Percentage of Subjects With Positive Anti-Certolizumab Pegol (CZP) Antibody Status at Any Time From Baseline of the Feeder Study C87076 to the Completion/Withdrawal Visit of the Extension Study|Antibody positive is defined as Anti-CZP antibody levels > 2.4 units/mL at any visit.|Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136)|Safety Set||percentage of participants|||Number
786533|NCT00843778|Secondary|Geometric Mean of Plasma Concentration of Certolizumab Pegol at Week 24 Visit|Plasma Samples for determination of Certolizumab Pegol were taken prior to Certolizumab Pegol administration. Values below the limit of quantification of 0.41 μg/mL will be set to half the limit of quantification for the summaries (0.205 μg/mL).|Week 24|Of the 130 subjects in the Safety Set, 89 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.||μg/mL||95% Confidence Interval|Geometric Mean
786534|NCT00843778|Secondary|Change From Baseline in PtGADA (Patient's Global Assessment of Disease Activity) at Completion/Withdrawal Visit|Change from Baseline in Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS) (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as the value at Completion/Withdrawal minus the Baseline value. A negative value in change from Baseline indicates an improvement.|Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to Week approximately 136)|Of the 130 subjects in the Full Analysis Set, 119 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.||units on a scale||Standard Deviation|Mean
786535|NCT00843778|Secondary|Change From Baseline in FAS (Fatigue Assessment Scale) at Completion/Withdrawal Visit|"Change from Baseline in Fatigue Assessment Scale (0 to 10, 0 is No Fatigue and 10 is Fatigue as bad as you can imagine) is computed as the value at Completion/Withdrawal minus the Baseline value. A negative value in change from Baseline indicates an improvement."|Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136)|Of the 130 subjects in the Full Analysis Set, 117 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.||units on a scale||Standard Deviation|Mean
786536|NCT00843778|Secondary|Change From Baseline in PtAAP (Patient's Assessment of Arthritis Pain) at Completion/Withdrawal Visit|Change from Baseline in Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS) (0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain) is computed as the value at Completion/Withdrawal minus the Baseline value. A negative value in change from Baseline indicates an improvement.|Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136)|Of the 130 subjects in the Full Analysis Set, 102 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.||units on a scale||Standard Deviation|Mean
786537|NCT00843778|Secondary|Change From Baseline in HAQ-DI (Health Assessment Questionnaire-Disability Index) at Completion/Withdrawal Visit|HAQ-DI is derived based on the mean of individual scores in 8 categories of daily living activities (using 20 questions). Each question is scored 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do). Thus, the mean also has a range from 0-3. Change from Baseline is computed as the value at Completion/Withdrawal minus the Baseline value. A negative value in change from Baseline indicates an improvement.|Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136)|Of the 130 subjects in the Full Analysis Set, 119 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.||units on a scale||Standard Deviation|Median
786538|NCT00843778|Secondary|Percentage of Subjects With ACR70 (American College of Rheumatology 70 % Improvement) Response at Completion/Withdrawal Visit|ACR70 response is defined for subjects with at least 70 % improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire- Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity, 5) Physician's Global Assessment of Disease Activity.|Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136)|Of the 130 subjects in the Full Analysis Set, 124 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.||percentage of participants|||Number
786539|NCT00843778|Secondary|Percentage of Subjects With ACR50 (American College of Rheumatology 50 % Improvement) Response at Completion/Withdrawal Visit|ACR50 response is defined for subjects with at least 50 % improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire- Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity, 5) Physician's Global Assessment of Disease Activity.|Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136)|Of the 130 subjects in the Full Analysis Set, 124 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.||percentage of participants|||Number
786540|NCT00843778|Secondary|Percentage of Subjects With ACR20 (American College of Rheumatology 20 % Improvement) Response at Completion/Withdrawal Visit|ACR20 response is defined for subjects with at least 20 % improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire- Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity, 5) Physician's Global Assessment of Disease Activity.|Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136)|Of the 130 subjects in the Full Analysis Set, 124 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.||percentage of participants|||Number
786541|NCT00843778|Secondary|Percentage of Subjects With SDAI (Simplified Disease Activity Index) Remission (SDAI ≤3.3) at Completion/Withdrawal Visit|SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm), and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. <= 3.3 (Remission), >3.3 - <= 11 Low, > 11 - <= 26 Moderate, > 26 High.|Completion/Withdrawal Visit (up to approximately Week 136)|Of the 130 subjects in the Full Analysis Set, 120 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.||percentage of participants|||Number
786542|NCT00843778|Secondary|Percentage of Subjects With CDAI (Clinical Disease Activity Index) Remission (CDAI ≤2.8) at Completion/Withdrawal Visit|CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm), and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. A lower CDAI score indicating improvement in activity and a higher score indicating a decline activity.|Completion/Withdrawal Visit (up to approximately Week 136)|Of the 130 subjects in the Full Analysis Set, 122 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.||percentage of participants|||Number
786543|NCT00843778|Secondary|Percentage of Subjects With DAS28[ESR] (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Remission (DAS28[ESR] < 2.6) at Completion/Withdrawal Visit|DAS28(ESR) is calculated using the tender joint count (TJC), swollen joint count (SJC) erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity. < 2.6 (Remission), > = 2.6 - < =3.2 Low, > 3.2 - < = 5.1 Moderate, > 5.1 High.|Completion/Withdrawal Visit (up to approximately Week 136)|Of the 130 subjects in the Full Analysis Set, 114 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.||percentage of participants|||Number
786544|NCT00843778|Primary|Percentage of Subjects With At Least One Treatment-emergent Serious Adverse Event (SAE) During The Study Period|A Serious Adverse Event is any untoward medical occurrence that at any dose results in death, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity is a congenital anomaly/birth defect.|From Entry Visit up to approximately 144 weeks|Safety Set||percentage of participants|||Number
786545|NCT00843778|Primary|Percentage of Subjects Reporting At Least One Treatment-emergent Adverse Event (TEAE) During The Study Period|A TEAE is defined as any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any phase of a clinical trial including Pretreatment, Run-In, Wash-Out, or Follow-Up Phases. A TEAE is defined as being independent of assumption of any causality (eg, to trial or concomitant medication, primary or concomitant disease, or trial design). TEAEs are all AEs in which the onset and time is after the first study drug administration in C87080, up to 70 days after the last injection.|From Entry Visit up to approximately 144 weeks|Safety Set||percentage of participants|||Number
786546|NCT00830791|Secondary|Plasma Glucose Concentration After Administration of a Single Oral Dose of 5 mg of MK-0941 to Participants With Severe Renal Insufficiency Versus Matched Controls|The glucose concentration-time profile was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and severe renal insufficiency who received 5 mg of MK-0941 versus controls with normal renal function who received 5 mg of MK-0941. Severe renal insufficiency was defined as a 24-hour CLCR of < 30 mL/min/1.73m^2.|Up to 12 Hours Post-Dose|This study was discontinued early and this evaluation was not conducted.|||||
786548|NCT00830791|Secondary|Plasma Glucose Concentration After Administration of a Single Oral Dose of 20 mg of MK-0941 to Participants With Mild Renal Insufficiency Versus Matched Controls|The glucose concentration-time profile was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and mild renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Mild renal insufficiency was defined as a 24-hour CLCR of > 50 to 80 mL/min/1.73m^2.|Up to 12 Hours Post-Dose|This study was discontinued early and this evaluation was not conducted.|||||
786549|NCT00830791|Secondary|CLCR After Administration of a Single Oral Dose of 5 mg of MK-0941 to Participants With Severe Renal Insufficiency Versus Matched Controls|CICR was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and severe renal insufficiency that received 5 mg of MK-0941 versus controls with normal renal function that received 5 mg of MK-0941. Severe renal insufficiency was defined as a 24-hour CLCR of < 30 mL/min/1.73m^2.|36-Hours Post-Dose|This study was discontinued early and this evaluation was not conducted.|||||
786550|NCT00830791|Secondary|CLCR After Administration of a Single Oral Dose of 20 mg of MK-0941 to Participants With Moderate Renal Insufficiency Versus Matched Controls|CICR was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency that received 20 mg of MK-0941 versus controls with normal renal function that received 20 mg of MK-0941. Moderate renal insufficiency was defined as a 24-hour CLCR of 30 to 50 mL/min/1.73m^2.|36-Hours Post-Dose|This study was discontinued early and this evaluation was not conducted.|||||
786551|NCT00830791|Secondary|CLCR After Administration of a Single Oral Dose of 20 mg of MK-0941 to Participants With Mild Renal Insufficiency Versus Matched Controls|CICR was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and mild renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Mild renal insufficiency was defined as a 24-hour CLCR of > 50 to 80 mL/min/1.73m^2.|36-Hours Post-Dose|This study was discontinued early and this evaluation was not conducted.|||||
786552|NCT00830791|Secondary|Fe After Administration of a Single Oral Dose of 5 mg of MK-0941 Among Participants With Severe Renal Insufficiency Versus Matched Controls|Fe was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency that received 5 mg of MK-0941 versus controls with normal renal function that received 5 mg of MK-0941. Severe renal insufficiency was defined as a 24-hour CLCR of < 30 mL/min/1.73m^2.|36-Hours Post-Dose|This study was discontinued early and this evaluation was not conducted.|||||
786553|NCT00830791|Secondary|Fe After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Moderate Renal Insufficiency Versus Matched Controls|Fe was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency that received 20 mg of MK-0941 versus controls with normal renal function that received 20 mg of MK-0941. Moderate renal insufficiency was defined as a 24-hour CLCR of 30 to 50 mL/min/1.73m^2.|36-Hours Post-Dose|This study was discontinued early and this evaluation was not conducted.|||||
786554|NCT00830791|Secondary|Amount of MK-0941 Excreted Unchanged in the Urine (Fe) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Mild Renal Insufficiency Versus Matched Controls|Fe was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and mild renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Mild renal insufficiency was defined as a 24-hour CLCR of > 50 to 80 mL/min/1.73m^2.|36-Hours Post-Dose|This study was discontinued early and this evaluation was not conducted.|||||
786555|NCT00830791|Secondary|T 1/2 After Administration of a Single Oral Dose of 5 mg of MK-0941 Among Participants With Severe Renal Insufficiency vs Matched Controls|T 1/2 was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and severe renal insufficiency who received 5 mg of MK-0941 versus controls with normal renal function who received 5 mg of MK-0941. Severe renal insufficiency was defined as a 24-hour CLCR of > 30 mL/min/1.73m^2.|72-Hours Post-Dose|This study was discontinued early and participants were not treated with the 5 mg dose.|||||
786556|NCT00830791|Secondary|T 1/2 After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Moderate Renal Insufficiency vs Matched Controls|T 1/2 was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency that received 20 mg of MK-0941 versus controls with normal renal function that received 20 mg of MK-0941. Moderate renal insufficiency was defined as a 24-hour CLCR of 30 to 50 mL/min/1.73m^2.|72-Hours Post-Dose|||Hours||Standard Deviation|Geometric Mean
786557|NCT00830791|Secondary|Time to Apparent Half Life (T 1/2) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Mild Renal Insufficiency vs Matched Controls|T 1/2 was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and mild renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Mild renal insufficiency was defined as a 24-hour CLCR of > 50 to 80 mL/min/1.73m^2.|72-Hours Post-Dose|||Hours||Standard Deviation|Geometric Mean
786558|NCT00830791|Secondary|Tmax After Administration of a Single Oral Dose of 5 mg of MK-0941 Among Participants With Severe Renal Insufficiency vs Matched Controls|Tmax was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and severe renal insufficiency who received 5 mg of MK-0941 versus controls with normal renal function who received 5 mg of MK-0941. Severe renal insufficiency was defined as a 24-hour CLCR of > 30 mL/min/1.73m^2.|72-Hours Post-Dose|This study was discontinued early and participants were not treated with the 5 mg dose.|||||
786559|NCT00830791|Secondary|Tmax After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Moderate Renal Insufficiency vs Matched Controls|Tmax was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Moderate renal insufficiency was defined as a 24-hour CLCR of 30 to 50 mL/min/1.73m^2.|72-Hours Post-Dose|||Hours||95% Confidence Interval|Geometric Mean
786560|NCT00830791|Secondary|Time to Maximum Plasma Concentration (Tmax) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Mild Renal Insufficiency vs Matched Controls|Tmax was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and mild renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Mild renal insufficiency was defined as a 24-hour CLCR of > 50 to 80 mL/min/1.73m^2.|72-Hours Post-Dose|||Hours||95% Confidence Interval|Geometric Mean
786561|NCT00830791|Secondary|Cmax After Administration of a Single Oral Dose of 5 mg of MK-0941 Among Participants With Severe Renal Insufficiency vs Matched Controls|Cmax was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and severe renal insufficiency who received 5 mg of MK-0941 versus controls with normal renal function who received 5 mg of MK-0941. Severe renal insufficiency was defined as a 24-hour CLCR of > 30 mL/min/1.73m^2.|72-Hours Post-Dose|This study was discontinued early and participants were not treated with the 5 mg dose.|||||
786562|NCT00830791|Secondary|Cmax After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Moderate Renal Insufficiency vs Matched Controls|Cmax was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Moderate renal insufficiency was defined as a 24-hour CLCR of 30 to 50 mL/min/1.73m^2.|72-Hours Post-Dose|||nM||95% Confidence Interval|Geometric Mean
786563|NCT00830791|Primary|Plasma AUC (0-infinity) After Administration of a Single Oral Dose of 5 mg of MK-0941 Among Participants With Severe Renal Insufficiency vs Matched Controls|Plasma AUC (0-infinity) was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and severe renal insufficiency taking a single oral dose of 5 mg of MK-0941 versus controls with normal renal function taking a single oral dose of 5 mg of MK-0941. Severe renal insufficiency was defined as a 24-hour CLCR of > 30 mL/min/1.73m^2.|72-Hours Post-Dose|This study was discontinued early and participants were not treated with the 5 mg dose.|||||
786564|NCT00830791|Primary|Plasma AUC (0-infinity) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among With Moderate Renal Insufficiency vs Matched Controls|Plasma AUC (0-infinity) was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency taking a single oral dose of 20 mg of MK-0941 versus controls with normal renal function taking a single oral dose of 20 mg of MK-0941. Moderate renal insufficiency was defined as a 24-hour CLCR of 30 to 50 mL/min/1.73m^2.|72-Hours Post-Dose|||nM per Hour||95% Confidence Interval|Geometric Mean
786565|NCT00830791|Primary|Plasma Area Under the Curve (AUC [0-infinity]) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Mild Renal Insufficiency vs Matched Controls|Plasma AUC (0-infinity) was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and mild renal insufficiency taking a single oral dose of 20 mg of MK-0941 versus controls with normal renal function taking a single oral dose of 20 mg of MK-0941. Mild renal insufficiency was defined as a 24-hour creatinine clearance (CLCR) of > 50 to 80 mL/min/1.73m^2.|72 Hours Post-Dose|||nM per Hour||95% Confidence Interval|Geometric Mean
786566|NCT00830791|Secondary|Maximum Plasma Concentration (Cmax) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Mild Renal Insufficiency vs Matched Controls|Cmax was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and mild renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Mild renal insufficiency was defined as a 24-hour CLCR of > 50 to 80 mL/min/1.73m^2.|72-Hours Post-Dose|||nM||95% Confidence Interval|Geometric Mean
786567|NCT00830804|Secondary|Plasma Trough Concentration of Darunavir|Plasma trough concentrations (ng/ml) of Darunavir (DRV) below the detection limit (50 ng/ml) were replaced by half the corresponding lower limit of quantitation. Geometric mean of trough concentrations obtained within the prescribed trough time (within 20-28 hours after the last DRV dose) was computed for each participant. For participants who experienced virologic failure (see primary outcome measure definition), only those concentrations on or before virologic failure confirmation were used in the geometric mean computation.|From start of study treatment to week 52|Participants who started study treatment and who have at least one DRV plasma trough concentration obtained within 20-28 hours after the last DRV dose were included in the analysis.||ng/ml||Inter-Quartile Range|Median
786568|NCT00830804|Secondary|Plasma Trough Concentration of Raltegravir|Plasma trough concentrations (ng/ml) of Raltegravir (RAL) below the detection limit (10 ng/ml) were replaced by half the corresponding lower limit of quantitation. Geometric mean of trough concentrations obtained within the prescribed trough time (within 9-15 hours after the last RAL dose) was computed for each participant. For participants who experienced virologic failure (see primary outcome measure definition), only those concentrations on or before virologic failure confirmation were used in the geometric mean computation.|From start of study treatment to week 52|Participants who started study treatment and who have at least one RAL plasma trough concentration obtained within 9-15 hours after the last RAL dose were included in the analysis.||ng/ml||Inter-Quartile Range|Median
786569|NCT00830804|Secondary|Change in CD4 Count at Week 48|Results report the week 48 change from baseline (week 48 - baseline) in CD4 count. Baseline CD4 count was computed as the mean of CD4 count values at pre-entry and study entry.|From start of study treatment through week 48|Only those participants who started study treatment and who have values at baseline and at week 48 were included in the analysis.||cells/mm3||Inter-Quartile Range|Median
786570|NCT00830804|Secondary|Change in Fasting Low-density Lipoprotein at Week 48|Results report the week 48 change from week 0 (week 48 - week 0) fasting low-density lipoprotein (LDL). For participants whose calculated fasting LDL and direct fasting LDL were both reported, only the calculated fasting LDL was used. Direct fasting LDL was reported when the participant had high fasting triglyceride.|From start of study treatment through week 48|Only those participants who started study treatment and who had fasting lipid measurements at week 48 and week 0 were included in the analysis.||mg/dL||Inter-Quartile Range|Median
786571|NCT00830804|Secondary|Changes in Fasting Total Cholesterol, High-density Lipoprotein and Triglyceride at Week 48|Results report the week 48 change from week 0 (week 48 - week 0) fasting total cholesterol, high-density lipoprotein and triglyceride.|From start of study treatment through week 48|Only those participants who started study treatment and who had fasting lipid measurements at week 48 and week 0 were included in the analysis.||mg/dL||Inter-Quartile Range|Median
786572|NCT00830804|Secondary|Change in Fasting Low-density Lipoprotein at Week 24|Results report the week 24 change from week 0 (week 24 - week 0) fasting low-density lipoprotein (LDL). For participants whose calculated fasting LDL and direct fasting LDL were both reported, only the calculated fasting LDL was used. Direct fasting LDL was reported when the participant had high fasting triglyceride.|From start of study treatment through week 24|Only those participants who started study treatment and who had fasting lipid measurements at week 24 and week 0 were included in the analysis.||mg/dL||Inter-Quartile Range|Median
786574|NCT00830804|Secondary|Number of Participants With Perfect Overall Adherence by Self Report|"At each study visit, adherence was measured in terms of the number of missed doses each participant had over a 4-day recall for each drug. Adherence for all study visit weeks were combined for an overall measure of adherence. Participants who had zero missed doses on all weeks in all drugs while on study were classified as having an overall perfect adherence."|From one week after starting study treatment to week 52|All participants who started study treatment were included in the analysis.||participants|||Number
786575|NCT00830804|Secondary|Number of Participants With Protease Drug Resistance at Virologic Failure|Results report the number of participants who had protease resistance mutation(s) detected at the time of virologic failure.|From 12 weeks after starting study treatment to week 52|Only those participants who had virologic failure (see primary outcome measure for definition) and who had successful protease genotyping at failure were included in the analysis.||participants|||Number
786576|NCT00830804|Secondary|Number of Participants With Integrase Drug Resistance at Virologic Failure|Results report the number of participants who had integrase resistance mutation(s) detected at the time of virologic failure.|From 12 weeks after starting study treatment to week 52|Only those participants who had virologic failure (see primary outcome measure for definition) and who had successful integrase genotyping at failure were included in the analysis.||participants|||Number
786577|NCT00830804|Secondary|Number of Participants With Pretreatment Drug Resistance|Results report the number of participants who had resistance to non-nucleoside reverse transciptase inhibitors (NNRTI), nucleoside reverse transciptase inhibitors (NRTI) and protease inbitors (PI) based on genotypic resistance testing done prior to participant's entry into the study. Participants are classified into one (and only one category) based on the maximum number of drug class resistance seen for the participant.|At screening|All participants who started study treatment were included in the analysis.||participants|||Number
786578|NCT00830804|Secondary|Proportion of Participants Who Experienced Signs/Symptoms or Laboratory Toxicities Grade 3 or Higher, or of Any Grade Which Led to a Permanent Change or Discontinuation of Study Treatment|Signs, symptoms and laboratory values were graded according to the Division of AIDS Adverse Event Grading System. Results report the percentage of participants who had grade 3 or higher events, or events of any grade which led to a permanent change or discontinuation of study treatment, which occurred any time from start of treatment to end of treatment.|From start of study treatment to week 52|All participants who started study treatment were included in the analysis.||proportion of participants||95% Confidence Interval|Number
786579|NCT00830804|Secondary|Proportion of Participants With Plasma HIV-1 RNA <50 Copies/ml or <200 Copies/ml at Week 48|Results report the percentage of participants with plasma HIV-1 RNA <50 copies/ml or <200 copies/ml at week 48.|From start of study treatment to week 48|All participants who started study treatment were included. An intent-to-treat approach was used ignoring participants who were off study treatment or with missing HIV-1 RNA at week 48.||proportion of participants||95% Confidence Interval|Number
786580|NCT00830804|Secondary|Proportion of Participants With Plasma HIV-1 RNA < 50 Copies/ml or <200 Copies/ml at Week 24|Results report the percentage of participants with plasma HIV-1 RNA < 50 copies/ml or <200 copies/ml at week 24.|From start of study treatment to week 24|All participants who started study treatment were included. An intent-to-treat approach was used ignoring participants who were off-study or with missing HIV-1 RNA at week 24.||proportion of participants||95% Confidence Interval|Number
786581|NCT00830804|Secondary|Change in Plasma HIV-1 RNA From Baseline to Week 1|Results report the week 1 change from baseline (week 1 - baseline) in HIV-1 RNA. Baseline HIV-1 RNA was computed as the mean of the log10 HIV-1 RNA values at pre-entry and study entry.|Baseline and week 1|Analyis was based on an intent-to-treat approach, ignoring whether a participant was on or off study treatment at the time the sample for HIV-1 RNA was obtained.||log10 copies/ml||Inter-Quartile Range|Median
786582|NCT00830804|Secondary|Proportion of Participants With Virologic Failure or Off Study Treatment Regimen or Death at or Prior to Week 24|The proportion of participants with virologic failure (see primary outcome measure for definition) and/or premature treatment discontinuation/modification and/or death was estimated using Kaplan-Meier method. An adaptation of Greenwood's variance estimate was used in constructing the confidence interval.|From start of study treatment to Week 24|All participants who started study treatment were included in the analysis.||Proportion of participants||95% Confidence Interval|Number
786583|NCT00830804|Primary|Proportion of Participants With Virologic Failure After Initiating RAL Plus DRV/RTV at or Prior to Week 24|Virologic failure is defined as: at week 12, confirmed plasma HIV-1 RNA >= 1000 copies/ml or confirmed rebound from the week 4 value by >0.5 log10 copies/ml (for subjects with week 4 value <= 50 copies/ml, confirmed rebound to >50 copies/ml); at week 24 or later, confirmed value > 50 copies/ml. Viral load confirmation was scheduled 7-35 days after initial virologic failure. The proportion was estimated using Kaplan-Meier method. An adaptation of Greenwood's variance estimate was used in constructing the confidence interval.|From start of study treatment to week 24|All participants who started study treatment were included. The intent-to-treat approach was used, ignoring whether a participant was on or off treatment at the time of HIV-1 RNA measurement and censoring follow-up if a participant was lost-to-follow-up without previously meeting the definition of virologic failure.||Proportion of participants||95% Confidence Interval|Number
786584|NCT00830947|Primary|The Rate of Orthodontic Movement of a Maxillary Canine Tooth Being Distalized to Close an Extraction Space.||Time to Space Closure, an average of 22 weeks|||mm/week||Standard Deviation|Mean
786585|NCT00830960|Secondary|Risk of CV Death, Nonfatal MI, Nonfatal Stroke, UTVR, or Recurrent Myocardial Ischemia Requiring Hospitalization (Analyzed Individually)|Risk of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Urgent Target Vessel Revascularization (UTVR), or Recurrent Myocardial Ischemia Requiring Hospitalization (Analyzed Individually)|30 days and 90 days|As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed; thus zero participants were analyzed.||participants|||Number
786628|NCT00843986|Secondary|Assessment of Dyspnea at Baseline, Hours 6, 12, 24 and 48 Using a Relative Dyspnea Assessment|"Dyspnea is defined as the sensation of uncomfortable or difficult breathing.
Changes in Dyspnea were assessed using the following 7-point Likert scale:
1-Markedly worse; 2-Moderately worse; 3-Mildly worse; 4-No change; 5-Mildly improved; 6-Moderately improved; 7-Markedly better/improved.
Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination."|Baseline, 6 Hours, 12 Hours, 24 Hours and 48 Hours|Study was terminated – assessment of this Outcome Measure was not performed.|||||
786586|NCT00830960|Secondary|Genetic Variation Related to Drug Metabolism and Transport Substudy Result Summary|"The primary hypothesis for the genetics substudy was that CYP2C19 genetic variation has a significant effect on pharmacodynamic (PD) response to clopidogrel but not on PD response to prasugrel per change in PRU as measured by the Accumetrics VerifyNow P2Y12 device.
Participants were classified by CYP2C19 genotype into predicted metabolic phenotypes according to literature-based functional predictions. These classifications were clustered into 2 groups: extensive metabolizer (EM) and reduced metabolizer (RM).
A higher value for change in PRU indicates a greater level of platelet inhibition."|Baseline to 4 hours post-loading dose (LD), 30 days and 90 days during maintenance dose (MD) phase|"Pharmacodynamic analysis set is subset of FAS (≥1 genetics sample, ≥1 dose of study drug, ≥1 post-baseline PRU measurement, no significant protocol violations). Genetics subset LD population never used glycoprotein (GP) IIb/IIIa inhibitor during index hospitalization.
Participants classified as EM or RM. Invalid measurements of PRU were excluded."||Change in PRU||Standard Deviation|Mean
786587|NCT00830960|Secondary|Inpatient Healthcare Resource Utilization|Healthcare resource utilization data were modeled from historical analyses to determine initial hospitalization costs, total 30-day medical care costs, and total 90-day medical care costs.|Initial hospitalization, 30 days, 90 days|As a consequence of the overall low number of reported clinical events, inpatient healthcare resource utilization data were not analyzed; thus zero participants were analyzed.||participants|||Number
786588|NCT00830960|Secondary|Incidence of CABG-related TIMI Major or Minor Bleeding.||Randomization through end of study (90 days)|"Safety Analysis Set (SAS): all randomized participants with at least 1 dose of study drug
In 10 participants, study drug discontinued due to planned CABG. 1 participant had CABG reported on revascularization case report form (CRF); no reports of CABG bleeding event"||participants|||Number
786589|NCT00830960|Secondary|Incidence of Non-coronary Artery Bypass Graft (CABG) Related Thrombolysis in Myocardial Infarction (TIMI) Life-threatening (a Subset of Non-CABG-related TIMI Major Bleeding), Major, Minor, and Minimal Bleeding|"Bleeding events were classified and analyzed in accordance with the TIMI criteria definitions.
Major bleeding: any intracranial hemorrhage (ICR) OR any clinically overt bleeding (including bleeding evident on imaging studies) associated with a fall in hemoglobin (Hgb) of ≥5 grams/deciliter (gm/dL) from baseline.
Minor bleeding: any clinically overt bleeding associated with a fall in Hgb of ≥3 but <5 gm/dL from baseline.
Insignificant bleeding: any bleeding event that does not meet criteria for a Major or Minor bleed."|Randomization through end of study (90 days)|"Safety analysis set (SAS): all randomized participants with at least 1 dose of study drug
Two (2) participants had no event date; time from start of therapy to event was missing and thus they were not included in this table."||participants|||Number
786590|NCT00830960|Secondary|Risk of All-cause Death in Primary Cohort and Low Weight/Elderly Cohort|Risk was defined as the number of participants with events of all-cause death.|Randomization through end of study (90 days)|Full Analysis Set (FAS): all randomized subjects who received at least 1 dose of study drug||Participants|||Number
786591|NCT00830960|Secondary|Risk of Definite, Probable, or Possible Stent Thrombosis Per Academic Research Consortium (ARC) Definition|"Risk was defined as the number of participants with events of definite, probable, or possible stent thrombosis.
As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed."|90 days|As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed; thus zero participants were analyzed.||participants|||Number
786592|NCT00830960|Secondary|Risk of Definite or Probable Stent Thrombosis Per ARC (Academic Research Consortium) Definition|"Risk was defined as the number of participants with events of definite or probable stent thrombosis.
As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed."|30 days and 90 days|As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed; thus zero participants were analyzed.||participants|||Number
786593|NCT00830960|Secondary|Risk of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Urgent Target Vessel Revascularization (UTVR), or Recurrent Myocardial Ischemia Requiring Hospitalization (Analyzed Individually)|Risk was defined as the number of participants with events of CV death, nonfatal MI, nonfatal stroke, UTVR, or recurrent myocardial ischemia requiring hospitalization.|30 days and 90 days|As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed; thus zero participants were analyzed.||participants|||Number
786594|NCT00830960|Secondary|Risk of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, or Recurrent Myocardial Ischemia Requiring Hospitalization|"Risk was defined as the number of events of CV death, nonfatal MI, nonfatal stroke or recurrent myocardial ischemia requiring hospitalization.
Recurrent myocardial ischemia requiring hospitalization: rehospitalization for symptoms of myocardial ischemia at rest with either new ST-segment deviation ≥1 mm, or performance of a coronary revascularization procedure percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) during the same hospital stay.
As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed."|30 days and 90 days|As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed; thus zero participants were analyzed.||Participants|||Number
786595|NCT00830960|Secondary|Risk of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Urgent Target Vessel Revascularization (UTVR)|"Risk was defined as the number of participants with events of CV death, nonfatal MI, or UTVR.
UTVR: percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) for recurrent ischemia. Revascularization must have included the vessel(s) dilated at the initial procedure.
As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed."|30 days and 90 days|As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed; thus zero participants were analyzed.||Participants|||Number
786629|NCT00843986|Secondary|Termination of Study Drug Due to an Adverse Event or Intolerability|Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination.|48.5 Hours|Study was terminated – assessment of this Outcome Measure was not performed.|||||
786630|NCT00843986|Secondary|Incidence of Use of Rescue Therapy or Other Intervention (Including Dialysis) Because of Worsening Renal Function|Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination.|Day 9|Study was terminated – assessment of this Outcome Measure was not performed.|||||
786596|NCT00830960|Secondary|Risk of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Non-fatal Stroke|"Risk was defined as the number of participants with events of CV death, nonfatal MI, or nonfatal stroke.
CV death: death caused by CV event or not clearly attributable to non-CV causes.
Nonfatal MI: per adapted American College of Cardiology definition.
Nonfatal stroke: rapid onset of new, persistent neurologic deficit lasting more than 24 hours; either ischemic or hemorrhagic based on imaging data, if available, or uncertain cause if imaging data was not available.
As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed."|30 days and 90 days|As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed; thus zero participants were analyzed.||participants|||Number
786597|NCT00830960|Primary|Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at 30 Days During Maintenance Dose (MD) Administration in Primary Cohort|"Efficacy analyses are analyzed and presented separately for the loading dose (LD) and MD phase. This primary outcome analysis compares PRU for the 3 prasugrel MDs (10 mg, 7.5 mg, and 5 mg) with the clopidogrel 75-mg MD at 30 days post-MD in the primary cohort (participants who weighed ≥60 kg and were <75 years).
ADP-induced PRU serves as a biomarker of clinical efficacy, with lower values indicating greater P2Y12 platelet inhibition.
Observed PRU values are presented with statistical comparisons of LS mean difference between prasugrel and clopidogrel."|At 30 days during MD therapy|"Per protocol set (PPS) MD population
PPS: all randomized participants who had at least 1 dose of study drug, ≥1 post-baseline platelet aggregation measurement, and no significant protocol violations
MD population: received percutaneous coronary intervention (PCI) for index event"||PRU||Standard Deviation|Mean
786598|NCT00830960|Secondary|Summary of Myocardial Infarction (MI), Stroke, Stent Thrombosis and Urgent Target Vessel Revascularization (UTVR) in Primary Cohort and Low Weight/Elderly Cohort|"Nonfatal MI: American College of Cardiology (ACC) definition Nonfatal stroke: rapid onset of new, persistent neurologic deficit lasting >24 hours; classified as either ischemic or hemorrhagic based on imaging data, if available, or uncertain cause if imaging data was not available.
Stent thrombosis: defined as definite, probable, or possible, based on Academic Research Consortium definitions.
UTVR: percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) for recurrent ischemia. Revascularization must have included the vessel(s) dilated at the initial procedure"|Randomization through end of study (90 days)|"Full analysis set (FAS)
FAS: all randomized subjects who received at least 1 dose of study drug"||Participants|||Number
786599|NCT00830960|Secondary|Percent Inhibition of Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) During the Maintenance Dose (MD) Phase at 30 Days and 90 Days in Primary Cohort and Low Weight/Elderly Cohort|A higher percentage (percent inhibition least squares mean [LS mean]) represents greater platelet inhibition.|30 days and at 90 days during MD therapy|"Per Protocol Set (PPS) MD population
PPS: all randomized participants who had at least 1 dose of study drug, ≥1 post-baseline platelet aggregation measurement, and no significant protocol violations
MD population: received percutaneous coronary intervention (PCI) for index event"||Percent inhibition|||Number
786600|NCT00830960|Secondary|Percent Inhibition of Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) at 30 Minutes, 2 Hours, and 4 Hours Post-Loading Dose (LD) in Primary in Primary Cohort and Low Weight/Elderly Cohort|A higher percentage (percent inhibition least squares mean [LS mean]) represents greater platelet inhibition.|30 minutes, 2 hours, and 4 hours following LD administration|Per Protocol Set (PPS) LD population PPS: all randomized participants with at least 1 dose study drug, ≥1 post-baseline platelet aggregation measurement, no significant protocol violations LD population: never used glycoprotein (GP) IIb/IIIa inhibitor during index hospitalization, received percutaneous coronary intervention (PCI) for index event||Percent inhibition|||Number
786601|NCT00830960|Secondary|Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at During Maintenance Dose (MD) Phase at 30 Days and 90 Days in Primary Cohort and Low Weight/Elderly Cohort|"Efficacy analyses analyzed and presented separately for loading dose (LD) and MD phase. Analysis compares PRU for 3 prasugrel MDs (10 mg, 7.5 mg, and 5 mg) with clopidogrel 75-mg MD at 30 days post-MD.
Data for Primary Cohort at 30 days post-LD, already presented in second Primary Outcome Measure, are also presented here.
ADP-induced PRU serves as a biomarker of clinical efficacy, with lower values indicating greater P2Y12 platelet inhibition.
Observed PRU values are presented with statistical comparisons of least squares (LS) mean difference between prasugrel and clopidogrel."|At 30 Days and 90 days during MD therapy|Per Protocol Set (PPS) MD population PPS: all randomized participants who had at least 1 dose of study drug, ≥1 post-baseline platelet aggregation measurement, and no significant protocol violations in MD population: received percutaneous coronary intervention (PCI) for index event||PRU||Standard Deviation|Mean
786602|NCT00830960|Secondary|Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at 30 Minutes, 2 and 4 Hours Post-Loading Dose (LD) in Primary (≥60 kg and <75 Years) and Low Weight/Elderly (<60 kg or ≥75 Years) Cohorts.|"Efficacy analyses analyzed and presented separately for LD and maintenance dose (MD) phase. Analysis compares PRU for prasugrel LDs (30 mg and 60 mg) with clopidogrel 300-mg LD at 30 minutes post-LD.
Data for Primary Cohort at 4 hours post-LD, already presented in first Primary Outcome Measure, are also presented here.
ADP-induced PRU serves as biomarker of clinical efficacy, with lower values indicating greater P2Y12 platelet inhibition.
Observed PRU values presented with statistical comparisons of least-squares mean (LS mean) difference between prasugrel and clopidogrel."|At 30 minutes, 2 hours, and 4 hours following LD administration|"Per Protocol Set (PPS) LD population PPS: all randomized participants with at least 1 dose study drug, ≥1 post-baseline platelet aggregation measurement, no significant protocol violations
LD population: never used glycoprotein (GP)IIb/IIIa inhibitor during index hospitalization, received percutaneous coronary intervention (PCI) for index event"||PRU||Standard Deviation|Mean
786631|NCT00843986|Secondary|Change in Renal Function From Baseline at Hours 24, 48 and Day 9 (or Day of Discharge) as Assessed by Serum Creatinine Concentration and Calculated Creatinine Clearance|"Calculated creatinine clearance is only calculated through hour 72 using the MDRD equation.
MDRD = Modification of Diet in Renal Disease
The MDRD equation is a standard calculation for estimated glomerular filtration rate.
Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination."|Baseline, 24 Hours, 48 Hours and Day 9|Study was terminated – assessment of this Outcome Measure was not performed.|||||
786603|NCT00830960|Primary|Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-mediated Platelet Aggregation (P2Y12 Reaction Units; PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at 4 Hours Post-Loading Dose (LD) in Primary Cohort (≥60 kg and <75 Years)|"ADP-induced PRU represents the rate and extent of ADP-stimulated platelet aggregation and serves as a biomarker of clinical efficacy, with lower values indicating greater P2Y12 platelet inhibition.
Observed PRU values are presented with statistical comparisons of difference in least squares mean (LS mean) PRU values between prasugrel and clopidogrel.
Efficacy analyses are analyzed and presented separately for the LD and maintenance dose (MD) phase."|At 4 hours following LD administration|"Per Protocol Set (PPS) LD population
PPS: all randomized participants with ≥1 dose study drug, ≥1 post-baseline platelet aggregation measurement, no significant protocol violations
LD population: never used glycoprotein (GP) IIb/IIIa inhibitor during index hospitalization and received percutaneous coronary intervention (PCI) for index event"||PRU||Standard Deviation|Mean
786604|NCT00831129|Secondary|Change in Body Mass Index|change in body mass index between baseline and 6 month|Baseline and 6 months|||kg/m2||Standard Deviation|Mean
786605|NCT00831129|Secondary|Change in Adiponectin|change in Adiponectin between baseline and 6 month|Baseline and 6 months|||μg/ml||Standard Deviation|Mean
786606|NCT00831129|Secondary|Change in Homeostatic Model Assessment for Insulin Resistance|change in homeostatic model assessment for insulin resistance between baseline and 6 month|Baseline and 6 months|||HOMA units||Standard Deviation|Mean
786607|NCT00831129|Secondary|Change in Insulin|change in Insulin between baseline and 6 month|Baseline and 6 months|||IU/ml||Standard Deviation|Mean
786608|NCT00831129|Secondary|Change in Fasting Blood Glucose|change in fasting blood glucose between baseline and 6 month|Baseline and 6 months|||mg/dl||Standard Deviation|Mean
786609|NCT00831129|Secondary|Change in Glycosylated Haemoglobin|change in glycosylated haemoglobin between baseline and 6 month|Baseline and 6 months|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
786610|NCT00831129|Secondary|Change in High-density Lipoprotein|change in high-density lipoprotein between baseline and 6 month|Baseline and 6 months|||mg/dl||Standard Deviation|Mean
786611|NCT00831129|Secondary|Change in Triglycerides|change in Triglycerides between baseline and 6 month|Baseline and 6 months|||mg/dl||Standard Deviation|Mean
786612|NCT00831129|Secondary|Change in Low-density Lipoprotein|change in low-density lipoprotein between baseline and 6 month|Baseline and 6 months|||mg/dl||Standard Deviation|Mean
786613|NCT00831129|Secondary|Change in (Ambulatory Blood Pressure Monitoring) Diastolic Blood Pressure|change in (ambulatory blood pressure monitoring) diastolic blood pressure between baseline and 6 month|Baseline and 6 months|||mm Hg||Standard Deviation|Mean
786614|NCT00831129|Secondary|Change in (Ambulatory Blood Pressure Monitoring) Systolic Blood Pressure|change in (ambulatory blood pressure monitoring) systolic blood pressure between baseline and 6 month|Baseline and 6 months|||mm Hg||Standard Deviation|Mean
786615|NCT00831129|Secondary|Change in Office Diastolic Blood Pressure|change in office diastolic blood pressure between baseline and 6 month|Baseline and 6 months|||mm Hg||Standard Deviation|Mean
786616|NCT00831129|Secondary|Change in Office Systolic Blood Pressure|change in office systolic blood pressure between baseline and 6 month|Baseline and 6 months|||mm Hg||Standard Deviation|Mean
786617|NCT00831129|Secondary|Change in Malondialdehyde|change in Malondialdehyde between baseline and 6 month|Baseline and 6 months|||nM||Standard Deviation|Mean
786618|NCT00831129|Secondary|Change in Urinary Isoprostane|change in urinary isoprostane between baseline and 6 month|Baseline and 6 months|||ng/ml||Standard Deviation|Mean
786619|NCT00831129|Primary|Change in High-sensitivity C-reactive Protein|change in high-sensitivity C-reactive between baseline and 6 month|Baseline and 6 months|||mg/dl||Standard Deviation|Mean
786620|NCT00843830|Secondary|Number of Patients That Respond to Treatment|To evaluate the anti-tumor response as determined by RECIST criteria|10 weeks|The primary objective could not be evaluated. The study was closed early secondary to inability to obtain grant funding to conduct.|||||
786621|NCT00843830|Primary|The Percentage of Participants That Patients Complete Radiation Therapy, All Three Vaccinations, and Evaluation for Tumor Response Four Weeks After the Third Vaccination.|The primary objective of this study was to evaluate the safety and feasibility of this combined modality protocol in patients with metastatic pancreatic carcinoma. The treatment will be deemed feasible if 80% or more patients complete radiation therapy, all three vaccinations, and evaluation for tumor response four weeks after the third vaccination.|10 weeks|The primary objective could not be evaluated. The study was closed early secondary to inability to obtain grant funding to conduct.|||||
786622|NCT00843843|Secondary|Psychomotor Vigilance|Fastest 10% reaction time (msec)|after short or long nights|Means||msec||Standard Deviation|Mean
786623|NCT00843843|Primary|Dim Light Melatonin Onset (Hours)|Gold standard marker of circadian timing|12 days from baseline to final dim light melatonin onset|||hours||Standard Deviation|Mean
786624|NCT00843986|Secondary|Total Urine Output at Hours 6, 12, 24, 48 and 72|Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination.|6 Hours, 12 Hours, 24 Hours, 48 Hours and 72 Hours|Study was terminated – assessment of this Outcome Measure was not performed.|||||
786625|NCT00843986|Secondary|Total Loop Diuretic Use Through 48 Hours|Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination.|48 Hours|Study was terminated – assessment of this Outcome Measure was not performed.|||||
786626|NCT00843986|Secondary|Change From Baseline in Body Weight at Hours 24, 48 and 72 and Days 6 and 9 (or Day of Discharge)|Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination.|Baseline, 24 Hours, 48 Hours, 72 Hours, Day 6 and Day 9|Study was terminated – assessment of this Outcome Measure was not performed.|||||
786627|NCT00843986|Secondary|Assessment of Dyspnea at Baseline, Hours 6, 12, 24 and 48 Using a Provocative Dyspnea Assessment|"Dyspnea is defined as the sensation of uncomfortable or difficult breathing.
The Provocative Dyspnea Assessment assesses dyspnea and changes in dyspnea from Baseline on a 5-point Likert scale at 5 different positions and assigns a Dyspnea Severity Score that ranges from 1 (worst severity) to 25 (least severity).
Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination."|Baseline, 6 Hours, 12 Hours, 24 Hours and 48 Hours|Study was terminated – assessment of this Outcome Measure was not performed.|||||
786633|NCT00843986|Primary|Assessment of Dyspnea at 24 Hours as Determined by a 7-point Likert Scale|"Dyspnea is defined as the sensation of uncomfortable or difficult breathing.
Changes in Dyspnea were assessed using the following 7-point scale: 1-Markedly worse; 2-Moderately worse; 3-Mildly worse; 4-No change; 5-Mildly improved; 6-Moderately improved; 7-Markedly better/improved.
Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination."|24 Hours|Study was terminated – assessment of this Outcome Measure was not performed.|||||
786634|NCT00843986|Primary|Change in Renal Function From Baseline at 72 Hours Assessed by Calculated Creatinine Clearance (MDRD Equation)|"MDRD = Modification of Diet in Renal Disease
The MDRD equation is a standard calculation for estimated glomerular filtration rate.
Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination."|Baseline and 72 Hours|Study was terminated – assessment of this Outcome Measure was not performed.|||||
786635|NCT00844051|Secondary|Rates of Absenteeism Among Children Attending Schools With and Without School-based Influenza Vaccination Programs||1 year|||days per 100 school days||Standard Deviation|Mean
786636|NCT00844051|Primary|Rates of Confirmed Influenza Illness in Vaccinated and Non-vaccinated Children Attending Schools With and Without School-based Influenza Vaccination Programs||1 year|||flu+ per 1000 children|||Number
786637|NCT00844090|Primary|Change in HbA1c Over Baseline|measure of longer term glycemic control. A1c measured at baseline 6 weeks and 6 months|6 months from baseline|per protocol||percentage of HbA1c||Standard Deviation|Median
786638|NCT00845897|Secondary|Barefoot Plantar Pressure|Novel emed pressure platform was used for data collection. A two-step method of data collection was used and a minimum of two trials of each foot were recorded. The plantar pressure map was divided into 3 horizontal masks using Percent Mask software and peak plantar pressure was determined for the forefoot region. Results are expressed in N/cm^2.|pre-injection, 2 weeks post injection, post healing, and 3 and 6 months post healing|||Peak Plantar Pressure (N/cm^2) changes||Standard Deviation|Mean
786639|NCT00845897|Primary|Plantar Flexor Muscle Strength|Concentric plantar flexor torque was assessed using the Biodex System 3 Pro Orthopedic Testing & Rehabilitation dynamometer. Plantar flexor peak torque was measured at 60 deg/sec, which is comparable to the angular velocity of the ankle joint during the stance phase of walking. Three trials of each foot were completed. Peak torque was calculated as the average of the two highest torque values across trials and results were expressed as Nm. A positive value represents an increase in torque while a negative value represents a decrease in torque.|Pre-treatment, 2 weeks after injection, upon ulcer healing, 3 months and 6 months after ulcer healing|||Plantar Flexor Torque (Nm)||Standard Deviation|Mean
786640|NCT00845975|Secondary|Spielberger State-Trait Anxiety Inventory (STAI)- Trait Portion|The Trait portion of the State-Trait Anxiety Inventory (STAI-T) evaluates an individual’s tendency to get anxious and how they respond to stress. The STAI-T has 20 items rated on a 4-point frequency of occurrence scale of 1=Almost Never, 2=Sometimes, 3=Moderately So, and 4=Very Much So. The individual scores are summed to get the total STAI-T score. The higher the total score, the more anxious the individual, and the lower the total score, the less anxious the individual. Change in STAI-T score is calculated as the STAI-T score at 4 weeks after baseline evaluation minus the STAI-T score at baseline. A positive (+) change in STAI-T score indicates that the anxiety has worsened. A negative (-) change in STAI-T score indicates the depression has lessened. A change in STAI-T score of -8 or greater indicates a meaningful lessening of anxiety and is positive for study success.|baseline and 4 weeks|||units on a scale||Standard Deviation|Mean
786641|NCT00845975|Secondary|Beck Depression Inventory-II (BDI-II)|The Beck Depression Inventory®-II (BDI®–II) is a 21-item questionnaire used to assess depression. Most items are rated on a 4-point scale from 0 to 3, and a few items are rated on a 7-point scale. Individual item scores are added to get a total score from 0 to 63. The higher the total score, the more severe the depression, and the lower the total score, the less severe the depression. Change in BDI®–II score is calculated as the BDI®–II score 4 weeks after baseline evaluation minus the BDI®–II score at baseline. A positive (+) change in BDI®–II score indicates that the depression has worsened. A negative (-) change in BDI®–II score indicates the depression has lessened. A change in BDI®–II score of -6 or greater indicates a meaningful lessening of depression and is positive for study success.|baseline and 4 weeks|||units on a scale||Standard Deviation|Mean
786642|NCT00845975|Primary|Total Score on the Tinnitus Handicap Inventory (THI).|The Tinnitus Handicap Inventory (THI) is a 25-item questionnaire to assess how tinnitus affects an individual’s life. Each question is responded to as ‘yes’ (4 points); ‘sometimes’ (2 points) or ‘no’ (0 points). The individual scores for the 25 questions are added to get a total THI score from 0 to 100. The higher the total THI score, the greater the negative impact tinnitus has on the individual’s life. Change in total THI score is calculated as total THI score after the one week procedure administration phase minus total THI score at baseline. A positive (+) change in total THI score indicates the negative impact of tinnitus on the individual’s everyday life has worsened. A negative (-) change indicates the negative impact of tinnitus on the individual’s everyday life has improved (lessened). A change in total THI score of -20 or greater indicates a meaningful lessening of the impact of tinnitus on the individual’s life and is positive for study success.|baseline and one week|||units on a scale||Standard Deviation|Mean
786643|NCT00846027|Secondary|Overall Survival|Overall survival is defined as the time from the first dose of study medication until death.|Baseline to the end of the study (up to 2 years 10 months)|Intent-to-treat population: All participants who were enrolled in the study.||Months||95% Confidence Interval|Median
786644|NCT00846027|Secondary|Duration of the Objective Response|Duration of the objective response is defined as the time from a complete or partial response to disease progression or death due to disease.|Baseline to the end of the study (up to 2 years 10 months)|Intent-to-treat population: All participants who were enrolled in the study. Only participants who had a response were included in the analysis.||Months||95% Confidence Interval|Median
786677|NCT00846495|Primary|Number of Migraine Attacks in Participants Using Frovatriptan in a Preemptive Treatment Paradigm vs. Daily Topiramate|Compare number of migraine attacks reported by participants using frovatriptan in a preemptive treatment paradigm vs. daily topiramate during Treatment Period Month 2|Treatment Month 2|Number of Units Analyzed is equivalent to number of migraine attacks reported during 2nd Treatment Month.||Migraine attacks|Participants|Standard Deviation|Mean
787378|NCT00850174|Secondary|AUC0-inf - 10-hydroxy-carbazepine Metabolite|Results of Metabolite for informational purposes only|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
786645|NCT00846027|Secondary|Percentage of Participants With an Objective Response|An objective response was defined as a complete or partial response determined on 2 consecutive occasions ≥ 4 weeks apart using Response Evaluation Criteria in Solid Tumors (RECIST). Complete response was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must be < 10 mm on the short axis. Partial response was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum.|Baseline to the end of the study (up to 2 years 10 months)|Intent-to-treat population: All participants who were enrolled in the study. Only participants who had a response evaluation were included in the analysis.||Percentage of participants||95% Confidence Interval|Number
786646|NCT00846027|Primary|Progression-free Survival|Progression-free survival was defined as the time from enrollment in the study to the first documented disease progression using Response Evaluation Criteria In Solid Tumors (RECIST) or death from any cause, whichever occurred first.|Baseline to the end of the study (up to 2 years 10 months)|Intent-to-treat population: All participants who were enrolled in the study.||Months||95% Confidence Interval|Median
786647|NCT00846066|Primary|Percent Change From Baseline in Practice of Oral Health Based on Pre and Post Study Chart Audit at 6 Months|The mean percent change in the documentation of oral health components at a well child visit. This was done by an audit of a random selection of 5 charts of patients who came in for well child visits, completed by each resident at baseline and at 6 months later.We scored this utilizing a 4 item checklist each correct item was scored as 1 (25%), with a maximum of 4(100%). The percentage change used the following formula {(mean score at 6 months-mean score at baseline)/mean score at baseline}*100%|At baseline and 6 months|Analysis per protocol. Subjects dropped from analysis because charts not available within the time frame of the study and incomplete data.||Percent change||Standard Deviation|Mean
786648|NCT00846066|Primary|Percent Change From Baseline in Opinions Regarding Incorporating Oral Health Into a Well Child Visit at 4 Months|"Opinions regarding incorporating oral health into a well child visit was measured by self administered surveys. The surveys used a 4 point Likert scale from 1 for (strongly disagree) to 4 for (strongly agree). Mean percentage change in the agree and strongly agree responses by the residents was compared between both groups. The percentage change equals {(mean score at 4 months-mean score at baseline)/ mean score at baseline} *100%"|Baseline and 4 months|||Percent change||Standard Deviation|Mean
786649|NCT00846066|Primary|Percent Change From Baseline in Confidence at 4 Months|"Confidence was measured by self-administered surveys regarding knowledge and practice of oral health. The surveys used a 4 point Likert scale (1=not confident, 4=very confident).The mean percent of change in the responses of very confident was compared between both groups. The percentage change equals {(mean score at 4 months-mean score at baseline)/ mean score at baseline} *100%"|Baseline and 4 months|Only completed paired (pre/post intervention) surveys were analyzed||Percent change.||Standard Deviation|Mean
786650|NCT00846066|Primary|Mean Percentage of Correct Skills|Skills were observed by pediatric dentists for each resident utilizing a six item checklist 3 months after the intervention (HOT) was completed.Each correct skill demonstrated was scored as 1 (16.67%) with a maximum of 6 representing 100%.The mean pecentage of correct skills were measured by direct observation by a pediatric dentist among the WBT alone and WBT+HOT groups|3 months after Hands-on Training (HOT)|||Percentage of correct skills||Standard Deviation|Mean
786651|NCT00846287|Secondary|Change in FEV1|Spirometry was taken which measures FEV1 (in Litres), before administration of an intervention and again 2 hours after administration of an intervention. The change in FEV1 (Litres) from pre-nebulizer inhalation to post-nebulizer inhalation was compared.|2 hours|As per protocol||Litres||Standard Deviation|Median
786652|NCT00846287|Primary|Change in Total Ventilation Volume|"Subjects had hyperpolarized helium-3 MR scans completed before administration of an intervention and 2 hours after administration. These images were compared as described:
The change in the total ventilation volume (Litres) measured in the hyperpolarized helium-3 MR image from pre-nebulizer inhalation to post-nebulizer inhalation."|2 hours|Analysis per protocol.||Litres||Standard Deviation|Mean
786653|NCT00846365|Secondary|Percentage of Participants Who Achieve a Clinic Diastolic AND Systolic Blood Pressure Response, Defined as <140/90 mm Hg for Participants Without Diabetes or Chronic Kidney Disease (CKD) or <130/80 mm Hg for Participants With Diabetes or CKD|Percentage of participants who achieve both a clinic diastolic blood pressure response, defined as <140/90 mm Hg for participants without diabetes or chronic kidney disease (CKD) or <130/80 mm Hg for participants with diabetes or CKD at each time frame relative to baseline.|Baseline, Week 2, Week 4, Week 6 and Week 8.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.||percentage of participants|||Number
786654|NCT00846365|Secondary|Percentage of Participants Who Achieve a Clinic Diastolic Blood Pressure Response, Defined as Defined as <90 mm Hg for Participants Without Diabetes or CKD or <80 mm Hg for Participants With Diabetes or CKD|Percentage of participants who achieve a clinic diastolic blood pressure response, defined as defined as <90 mm Hg for participants without diabetes or CKD or <80 mm Hg for participants with diabetes or CKD at each time frame relative to baseline.|Baseline, Week 2, Week 4, Week 6 and Week 8.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.||percentage of participants|||Number
786655|NCT00846365|Secondary|Percentage of Participants Who Achieve a Clinic Systolic Blood Pressure Response, Defined as <140 mm Hg for Participants Without Diabetes or CKD or <130 mm Hg for Participants With Diabetes or CKD|Percentage of participants who achieve a clinic systolic blood pressure response, defined as <140 mm Hg for participants without diabetes or CKD or <130 mm Hg for participants with diabetes or CKD at each time frame relative to baseline.|Baseline, Week 2, Week 4, Week 6 and Week 8.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.||percentage of participants|||Number
787379|NCT00850174|Secondary|Cmax - 10-hydroxy-carbazepine in Plasma|Results of Metabolite for Informational Purposes Only|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
786656|NCT00846365|Secondary|Change From Baseline in 12-hr Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 0 to 12 hours-after-dosing mean diastolic blood pressure measured at Week 4 and Week 8 to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The mean consists of the average (arithmetic mean) of measurements collected at each time frame and includes all observations recorded over the subsequent 12 hours.|Baseline, Week 4 and Week 8.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.||mmHg||Standard Error|Least Squares Mean
786657|NCT00846365|Secondary|Change From Baseline in 12-hr Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 0 to 12 hours-after-dosing mean Systolic Blood Pressure measured at Week 4 and Week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night The mean consists of the average (arithmetic mean) of measurements collected at each time frame and includes all observations recorded over the subsequent 12 hours.|Baseline, Week 4 and Week 8.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.||mmHg||Standard Error|Least Squares Mean
786658|NCT00846365|Secondary|Change From Baseline in Nighttime Mean (12am to 6am) Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the nighttime, while asleep (12am to 6am) mean diastolic blood pressure measured at Week 4 and Week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average (arithmetic mean) of measurements recorded between the hours of 12 AM (inclusive) and 6 AM (exclusive) included in the 24-hour mean calculations.|Baseline, Week 4 and Week 8.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.||mmHg||Standard Error|Least Squares Mean
786659|NCT00846365|Secondary|Change From Baseline in Nighttime Mean (12am to 6am) Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring|The change in the nighttime, while asleep (12am to 6am) mean systolic blood pressure measured at Week 4 and Week 8 to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of measurements recorded between the hours of 12 AM (inclusive) and 6 AM (exclusive) included in the 24-hour mean calculations.|Baseline, Week 4 and Week 8.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.||mmHg||Standard Error|Least Squares Mean
786660|NCT00846365|Secondary|Change From Baseline in Daytime Mean (6am to 10pm) Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the daytime, while awake (6am to 10pm) mean diastolic blood pressure measured at Week 4 and Week 8relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of measurements recorded between the hours of 6 AM (inclusive) and 10 PM (exclusive) included in the 24-hour mean calculations.|Baseline, Week 4 and Week 8.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.||mmHg||Standard Error|Least Squares Mean
786661|NCT00846365|Secondary|Change From Baseline in Daytime Mean (6am to 10pm) Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the daytime, while awake (6am to 10pm) mean systolic blood pressure measured at Week 4 and Week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night Daytime mean is the average of measurements recorded between the hours of 6 AM (inclusive) and 10 PM (exclusive) included in the 24-hour mean calculations.|Baseline, Week 4 and Week 8.|Full analysis set , all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.||mmHg||Standard Error|Least Squares Mean
786662|NCT00846365|Secondary|Change From Baseline in 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 0 to 24-hours-after-dosing mean diastolic blood pressure measured at Week 4 and Week 8 relative to baseline. . Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The mean consists of the average of measurements collected over the subsequent 24 hours.|Baseline, Week 4 and Week 8.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.||mmHg||Standard Error|Least Squares Mean
786663|NCT00846365|Secondary|Change From Baseline in 24-hour Mean Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring.|The change in the 24-hour mean systolic blood pressure at week4 and week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline, Week 4 and Week 8.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.||mmHg||Standard Error|Least Squares Mean
786678|NCT00846521|Primary|Mean Percentage of Glucose Values ≥ 140 mg/dl Over 72 Hours of Glucose Readings Measured With a Continuous Glucose Monitor||After 6 Weeks (post treatment)|The number of participants who completed the study were analyzed||percentage of glucose excursions ≥ 140||Standard Deviation|Mean
786664|NCT00846365|Secondary|Change From Baseline in Trough Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough systolic blood pressure measured at week 4 and week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Trough is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline, Week 4 and Week 8.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.||mmHg||Standard Error|Least Squares Mean
786665|NCT00846365|Secondary|Change From Baseline in Trough Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough systolic blood pressure measured at week 4 and week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Trough is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline, Week 4 and Week 8.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.||mmHg||Standard Error|Least Squares Mean
786666|NCT00846365|Secondary|Change From Baseline in Trough, Sitting, Clinic Diastolic Blood Pressure|The change in trough diastolic blood pressure measured at week 4 and week 8 relative to baseline. Diastolic blood pressure is the average of the 3 serial trough sitting diastolic blood pressure measurements.|Baseline, Week 4 and Week 8.|Full analysis set , all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.||mmHg||Standard Deviation|Least Squares Mean
786667|NCT00846365|Secondary|Change From Baseline to Week 4 in Trough, Sitting, Clinic Systolic Blood Pressure.|The change in trough systolic blood pressure measured at week 4 relative to baseline. Systolic blood pressure is the average of the 3 serial trough sitting systolic blood pressure measurements.|Baseline and Week 4.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.||mmHg||Standard Deviation|Least Squares Mean
786668|NCT00846365|Primary|Change From Baseline to Week 8 in Trough, Sitting, Clinic Systolic Blood Pressure.|The change in trough systolic blood pressure measured at week 8 or final visit relative to baseline. Systolic blood pressure is the average of the 3 serial trough sitting systolic blood pressure measurements.|Baseline and Week 8.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.||mmHg||Standard Deviation|Least Squares Mean
786669|NCT00846391|Primary|Change From Baseline in 24-hour Weighted Mean Glucose (WMG) at Week 4|"The 24-hour WMG is derived from multiple glucose values collected during both fasting and post-meal periods. A weighted rather than a simple mean is used to avoid overrepresentation of post-meal glucose values.
Blood samples for glucose were to be collected immediately prior to (sample -10 minutes), and 0, 15, 30, 60, 90, 120, and 180 minutes after each meal, and overnight (at midnight, 3 AM, and 5 AM) and fasting at 7 AM. Patients were to be domiciled for approximately 26 hours at the site where standard meals were provided and physical activity monitored."|Baseline and Week 4|The analysis population included all patients with a baseline value and Week 4 value for this outcome.||mg/dL||Standard Deviation|Mean
786670|NCT00846495|Secondary|Cost of Frovatriptan vs. Topiramate as Preventive Treatment of Migraine|Average cost of study medication taken by each subject. Measured in dollars.|Treatment Months 1 and 2|||Dollars (US)||Standard Deviation|Mean
786671|NCT00846495|Secondary|Adverse Events Associated With Study Medications|Includes Adverse Events at or above 5% frequency per group.|Treatment Months 1 and 2|||Adverse Events|Participants||Number
786672|NCT00846495|Secondary|Participant Satisfaction With Study Medications|"Participant satisfaction is measured by the Patient Perception of Migraine Questionnaire (PPMQ). Questions were categorized within 6 dimensions: Efficacy, Functionality, Ease of Use, Cost, Bothersomeness of Side Effects, and Total Score. Scores range from 0 to 100. Higher scores represent better satisfaction.
Participants completed the PPMQ 24 hours following each first dose of frovatriptan."|Treatment Month 2|||Score on a Scale||Standard Deviation|Mean
786673|NCT00846495|Secondary|Quality of Life in Subjects Utilizing Each Treatment Paradigm|Quality of Life is measured by the Migraine Specific Quality of Life Questionnaire (MSQ), which includes 3 dimensions: Role Function Restrictive (degree to which performance of daily activities is limited), Role Function Preventive (degree to which performance of daily activities is interrupted), and Emotional Function (frustration and helplessness due to migraine). Scores range from 0 to 100. For each dimension, a higher score indicates a better health status. Participants completed the MSQ at Randomization, and after Treatment Months 1 and 2.|Randomization, End of Treatment Month 1, End of Treatment Month 2|||Score on a Scale||Standard Deviation|Mean
786674|NCT00846495|Secondary|Participants With Greater Than 50% Reduction in Migraine Attacks and Headache Days Per Month Utilizing Each Treatment Paradigm|Compare number of participants with greater than 50% reduction in migraine attacks and headache days from Baseline to Treatment Months 1 and 2|2 Months|||Participants|||Number
786675|NCT00846495|Secondary|Number of Headache Days Each Month Following Initiation of Treatment With Study Medication|Measure the change in number of headache days reported by participants during each treatment month following initiation of treatment with study medication|2 Months|Number of Units Analyzed is equivalent to number of headache days reported during Treatment Months 1 and 2.||Headache Days|Participants|Standard Deviation|Mean
786676|NCT00846495|Primary|Number of Headache Days Reported by Participants Using Frovatriptan in a Preemptive Treatment Paradigm vs. Daily Topiramate to Prevent Migraine|Measure the change in number of headache days between participants using frovatriptan in a preemptive treatment paradigm vs. daily topiramate to prevent migraine|Treatment Month 2|||Headache Days||Standard Deviation|Mean
786679|NCT00846521|Primary|Mean Percentage of Glucose Values ≥ 140 mg/dl Over 72 Hours of Glucose Readings Measured With a Continuous Glucose Monitor||At baseline (before treatment)|The number of participants who completed the study were analyzed||percentage of glucose excursions ≥ 140||Standard Deviation|Mean
786680|NCT00846547|Primary|Irritability Subscale of the Aberrant Behavior Checklist, Community Version|The Aberrant Behavior Checklist-Community Edition (ABC-C) is a 58-item questionnaire composed of five different independent subscales. The questionnaire is completed by the parent/caregiver and lists aberrant behaviors and asks about the severity of the problem. ABC-Irritability is one of the subscales and comprises of 15 items. Minimum score is 0, maximum is 45. A decreased score indicates few aberrant behaviors and clinical improvement. The entire ABC-C assessment is administered at baseline and then at the end of each Intervention Period (4 weeks after Baseline).|At 8 weeks during the treatment period|||Points on a scale||Standard Error|Least Squares Mean
786681|NCT00846573|Primary|Hyperpolarized Helium-3 MR Images|We have applied hyperpolarized 3He MR imaging to a range of subject with various disorders. We have developed our scanning techniques so as to acquire optimized images for each disorder.|15 second breath-hold|We recruited participants of each category until we were satisfied with the images we obtained.||participants|||Number
786682|NCT00846586|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose at the End of Treatment (Week 12)|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, and 4 hours post-dose at the end of treatment (Week 12). Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|From 5 minutes to 4 hours post-dose at the end of treatment (Week 12)|Full analysis set (FAS): All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).||Liters||Standard Error|Least Squares Mean
786683|NCT00846586|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose on Day 1|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, and 4 hours post-dose on Day 1. Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|From 5 minutes to 4 hours post-dose on Day 1|Full analysis set (FAS): All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).||Liters||Standard Error|Least Squares Mean
786684|NCT00846586|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose on Day 2|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 23 hours 10 minutes and 23 hours 45 minutes post-dose on Day 2. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|24 hours post-dose on Day 2|Full analysis set (FAS): All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).||Liters||Standard Error|Least Squares Mean
786685|NCT00846586|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 8 Hours Post-dose on Day 1|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, 4, 6, and 8 hours post-dose on Day 1. Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|From 5 minutes to 8 hours post-dose on Day 1|Full analysis set (FAS): All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).||Liters||Standard Error|Least Squares Mean
786686|NCT00846586|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Treatment (Week 12 + 1 Day, Day 85)|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of the study (Week 12 + 1 day, Day 85). The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|24 hours post-dose at the end of treatment (Week 12 + 1 day, Day 85)|Full analysis set (FAS): All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).||Liters||Standard Error|Least Squares Mean
786687|NCT00846586|Primary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 8 Hours Post-dose at the End of Treatment (Week 12)|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, 4, 6, and 8 hours post-dose at the end of the study (Week 12, Day 84). Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|From 5 minutes to 8 hours post-dose at the end of treatment (Week 12, Day 84)|Full analysis set (FAS): All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).||Liters||Standard Error|Least Squares Mean
786694|NCT00846768|Secondary|Pharmacokinetics (PK): Fraction of Analyte Eliminated in Urine at Steady State From Time Point 0 Hours to Time Point 24 Hours|Fraction of analyte eliminated in urine at steady state from time point 0 hours to time point 24 hours after dosing in week 3. The start of inhalation was used as time point 0 for calculation of pharmacokinetic parameters. Descriptive statistics were calculated only if N>=16 had concentrations within the validated concentration range.|3 weeks|"All evaluable subjects. A subject was considered to be not evaluable if the subject had a protocol violation relevant to the evaluation of PK parameters or had insufficient data.
This endpoint was only calculated for the two qd dose regimens, therefore the number of patients in the Olo 2 Mcg Bid Arm and the Olo 5 Mcg Bid Arm is 0."||percent||Geometric Coefficient of Variation|Geometric Mean
786695|NCT00846768|Secondary|Pharmacokinetics (PK): Fraction of Analyte Eliminated in Urine at Steady State From Time Point 0 Hours to Time Point 12 Hours|"Fraction of analyte eliminated in urine at steady state from time point 0 hours to time point 12 hours after dosing in week 3 (after the morning dose for the bid dose regimens). The start of inhalation was used as time point 0 for calculation of pharmacokinetic parameters.
Descriptive statistics were calculated only if N>=16 had concentrations within the validated concentration range."|3 weeks|All evaluable subjects. A subject was considered to be not evaluable if the subject had a protocol violation relevant to the evaluation of PK parameters or had insufficient data.||percent||Geometric Coefficient of Variation|Geometric Mean
786696|NCT00846768|Secondary|Pharmacokinetics (PK): Amount of Analyte That is Eliminated in Urine at Steady State From the Time Point 0 Hours to Time Point 24 Hours|Amount of analyte that is eliminated in urine at steady state from the time point 0 hours to time point 24 hours after dosing in week 3. The start of inhalation was used as time point 0 for calculation of pharmacokinetic parameters. Descriptive statistics were calculated only if N>=16 had concentrations within the validated concentration range.|3 weeks|"All evaluable subjects. A subject was considered to be not evaluable if the subject had a protocol violation relevant to the evaluation of PK parameters or had insufficient data.
This endpoint was only calculated for the two qd dose regimens, therefore the number of patients in the Olo 2 Mcg Bid Arm and the Olo 5 Mcg Bid Arm is 0."||ng||Geometric Coefficient of Variation|Geometric Mean
786697|NCT00846768|Secondary|Pharmacokinetics (PK): Amount of Analyte That is Eliminated in Urine at Steady State From the Time Point 0 Hours to Time Point 12 Hours|"Amount of analyte that is eliminated in urine at steady state from the time point 0 hours to time point 12 hours after dosing in week 3 (after the morning dose for the bid dose regimens). The start of inhalation was used as time point 0 for calculation of pharmacokinetic parameters.
Descriptive statistics were calculated only if N>=16 had concentrations within the validated concentration range."|3 weeks|All evaluable subjects. A subject was considered to be not evaluable if the subject had a protocol violation relevant to the evaluation of PK parameters or had insufficient data.||ng||Geometric Coefficient of Variation|Geometric Mean
786698|NCT00846768|Secondary|Pharmacokinetics (PK): Concentration of the Analyte in Plasma Measured at 0.167 Hours Post Dosing at Steady State|Steady state concentration of the analyte in plasma measured at 0.167 hours post dosing in week 3. The start of inhalation was used as time point 0 for calculation of pharmacokinetic parameters. Descriptive statistics were calculated only if N>=16 had concentrations within the validated concentration range.|3 weeks|"All evaluable subjects. A subject was considered to be not evaluable if the subject had a protocol violation relevant to the evaluation of PK parameters or had insufficient data. In the Olo 2 mcg Bid Arm, there were only 14 patients with values within the validated concentration range."||pg/mL||Geometric Coefficient of Variation|Geometric Mean
786699|NCT00846768|Secondary|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis, ECG and Physical Examination|Clinical relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsenings of baseline conditions were reported as Adverse Events related to treatment (cardiac disorders and investigations).|3 weeks|Treated set.||percentage of participants|||Number
786700|NCT00846768|Secondary|Trough FVC Response|Response was defined as change from baseline. Study baseline trough FVC was defined as the mean of the available pre-dose trough FVC values prior to first dose of treatment. Trough values were the mean of values obtained 23h and 23 h 50 min after the last dose of study drug after three weeks of treatment .|Baseline, 3 weeks|Full analysis set (FAS). FAS is defined as all randomised and treated patients with baseline (pre-dose) data and evaluable post-dose data for at least one period.||Liter||Standard Error|Least Squares Mean
786701|NCT00846768|Secondary|Peak FVC (0-3h) Response After 3 Weeks|Response was defined as change from baseline. Study baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after the last dose after three weeks of treatment.|Baseline, 3 weeks|Full analysis set (FAS). FAS is defined as all randomised and treated patients with baseline (pre-dose) data and evaluable post-dose data for at least one period.||Liter||Standard Error|Least Squares Mean
786702|NCT00846768|Secondary|FVC Area Under Curve 0-24 h (AUC 0-24h) Response After 3 Weeks of Treatment|Response was defined as change from baseline. Baseline FVC AUC (0-24) was defined as the AUC performed on the baseline visit, prior to the first dose of randomized treatment. FVC AUC 0-24h was calculated from 0-24 hours post-dose using the trapezoidal rule, divided by the observation time (24h) to report in litres.|Day0:-0:10,0:30,1,2,3,4,6,8,10,11:50h relative to planned morning dose on day1, 0:30,1,2,10,11,11:50h relative to planned evening dose on day1; Day21:-0:10,0:30,1,2,3,4,6,8,10,11:50h relative to morning dose,0:30,1,2,10,11,11:50h relative to evening dose|Full analysis set (FAS). FAS is defined as all randomised and treated patients with baseline (pre-dose) data and evaluable post-dose data for at least one period.||Liter||Standard Error|Least Squares Mean
786703|NCT00846768|Secondary|FVC Area Under Curve 12-24 h (AUC 12-24h) Response After 3 Weeks of Treatment|Response was defined as change from baseline. Baseline FVC AUC (12-24) was defined as the AUC performed on the baseline visit, prior to the first dose of randomized treatment. FVC AUC 12-24h was calculated from 12-24 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|Day 0: -0:10, 0:30, 1, 2, 10, 11, 11:50 h relative to planned evening dose on day 1; Day 21: -0:10, 0:30, 1, 2, 10, 11, 11:50 h relative to evening dose|Full analysis set (FAS). FAS is defined as all randomised and treated patients with baseline (pre-dose) data and evaluable post-dose data for at least one period.||Liter||Standard Error|Least Squares Mean
786704|NCT00846768|Secondary|FVC Area Under Curve 0-12 h (AUC 0-12h) Response After 3 Weeks of Treatment|Response was defined as change from baseline. Baseline FVC AUC (0-12) was defined as the AUC performed on the baseline visit, prior to the first dose of randomized treatment. FVC AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|Day 0: -0:10, 0:30, 1, 2, 3, 4, 6, 8, 10, 11:50 h relative to planned morning dose on day 1; Day 21: -0:10, 0:30, 1, 2, 3, 4, 6, 8, 10, 11:50 h relative to morning dose|Full analysis set (FAS). FAS is defined as all randomised and treated patients with baseline (pre-dose) data and evaluable post-dose data for at least one period.||Liter||Standard Error|Least Squares Mean
786705|NCT00846768|Secondary|Trough FEV1 Response|Response was defined as change from baseline. Study baseline trough FEV1 was defined as the mean of the available pre-dose trough FEV1 values prior to first dose of treatment. Trough values were the mean of values obtained 23h and 23 h 50 min after the last dose of study drug after three weeks of treatment .|Baseline, 3 weeks|Full analysis set (FAS). FAS is defined as all randomised and treated patients with baseline (pre-dose) data and evaluable post-dose data for at least one period.||Liter||Standard Error|Least Squares Mean
786706|NCT00846768|Secondary|Peak FEV1 (0-3h) Response After 3 Weeks|Response was defined as change from baseline. Study baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after the last dose after three weeks of treatment.|Baseline, 3 weeks|Full analysis set (FAS). FAS is defined as all randomised and treated patients with baseline (pre-dose) data and evaluable post-dose data for at least one period.||Liter||Standard Error|Least Squares Mean
786707|NCT00846768|Secondary|FEV1 Area Under Curve 0-24 h (AUC 0-24h) Response After 3 Weeks of Treatment|Response was defined as change from baseline. Baseline FEV1 AUC (0-24) was defined as the AUC performed on the baseline visit, prior to the first dose of randomized treatment. FEV1 AUC 0-24h was calculated from 0-24 hours post-dose using the trapezoidal rule, divided by the observation time (24h) to report in litres.|Day0:-0:10,0:30,1,2,3,4,6,8,10,11:50h relative to planned morning dose on day1,0:30,1,2,10,11,11:50h relative to planned evening dose on day1; Day21:-0:10,0:30,1,2,3,4,6,8,10,11:50h relative to morning dose,0:30,1,2,10,11,11:50h relative to evening dose|Full analysis set (FAS). FAS is defined as all randomised and treated patients with baseline (pre-dose) data and evaluable post-dose data for at least one period.||Liter||Standard Error|Least Squares Mean
786708|NCT00846768|Primary|FEV1 Area Under Curve 12-24 h (AUC 12-24h) Response After 3 Weeks of Treatment|Response was defined as change from baseline. Baseline FEV1 AUC (12-24) was defined as the AUC performed on the baseline visit, prior to the first dose of randomized treatment. FEV1 AUC 12-24h was calculated from 12-24 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|Day 0: -0:10, 0:30, 1, 2, 10, 11, 11:50 h relative to planned evening dose on day 1; Day 21: -0:10, 0:30, 1, 2, 10, 11, 11:50 h relative to evening dose|Full analysis set (FAS). FAS is defined as all randomised and treated patients with baseline (pre-dose) data and evaluable post-dose data for at least one period.||Liter||Standard Error|Least Squares Mean
786709|NCT00846768|Primary|FEV1 Area Under Curve 0-12 h (AUC 0-12h) Response After 3 Weeks of Treatment|Response was defined as change from baseline. Baseline FEV1 AUC (0-12) was defined as the AUC performed on the baseline visit, prior to the first dose of randomized treatment. FEV1 AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|Day 0: -0:10, 0:30, 1, 2, 3, 4, 6, 8, 10, 11:50 h relative to planned morning dose on day 1; Day 21: -0:10, 0:30, 1, 2, 3, 4, 6, 8, 10, 11:50 h relative to morning dose|Full analysis set (FAS). FAS is defined as all randomised and treated patients with baseline (pre-dose) data and evaluable post-dose data for at least one period.||Liter||Standard Error|Least Squares Mean
786710|NCT00846807|Secondary|Percentage of Patients With Single Components of Composite of sVTE and All-cause Mortality||From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa|TS||Percentage of participants||95% Confidence Interval|Number
786711|NCT00846807|Secondary|Volume of Wound Drainage (Post-operative)|Total volume of wound drainage is calculated as sum of volume drainage from end of surgery until first dose of Pradaxa plus volume drainage from first dose of Pradaxa and onwards.|From end of surgery (before first dosing) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa|TS||ml||Standard Deviation|Mean
786712|NCT00846807|Secondary|Percentage of Patients With Major Extra-surgical Site Bleedings||From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa|TS||Percentage of participants||95% Confidence Interval|Number
786713|NCT00846807|Primary|Percentage of Patients With Symptomatic Venous Thromboembolic Events (sVTE) and All Cause Mortality|The co-primary efficacy variable sVTE was defined as the composite of documented symptomatic proximal and distal deep vein thrombosis (DVT) and documented symptomatic non-fatal pulmonary embolism (PE).|From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa|TS||Percentage of participants||95% Confidence Interval|Number
786714|NCT00846807|Primary|Percentage of Patients With Major Bleeding Events (MBE) During Treatment Period|Major bleeding events were defined according to the modified McMaster criteria, and were classified by the investigator as Major bleeding event or Any bleeding event. The criteria for MBE's were: fatal; clinically overt associated with loss of haemoglobin >=20g/L in excess of what was expected; clinically overt leading to the transfusion of >=2 units packed cells or whole blood in excess of what was expected; symptomatic retroperitoneal, intracranial, intraocular or intraspinal; requiring treatment cessation; leading to re-operation|From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa|Treated Set (TS) comprises all patients who completed the surgery and received at least 1 dose of dabigatran etexilate.||Percentage of participants||95% Confidence Interval|Number
786742|NCT00847197|Secondary|Percent Change From Baseline in Triglycerides (mg/dL)||Baseline and 4 Weeks|The Full Analysis Set (FAS) population served as the primary population for the analysis of efficacy data. FAS is a subset of all randomized participants with following reasons for exclusion: 1. failure to receive at least 1 dose of study treatment 2. lack of any post-randomization endpoint data subsequent to at least 1 dose of study treatment.||Percent Change||Standard Deviation|Mean
786715|NCT00846846|Secondary|Composites of (Cardiac) Death and (Large) Non-fatal Myocardial Infarctions.|Total death and and number of patients with all non-fatal myocardial infarction. Cardiac death and number of patients with all non-fatal myocardial infarction. Total death and number of patients with large non-fatal myocardial infarction. Cardiac death and number of patients with large non-fatal myocardial infarction.|3 years|Main secondary endpoint results for the ITT population are similar to the primary endpoint analysis, a total of nine hundred and forty seven (947) ITT patients had sufficient follow-up or an event to be included in the main secondary endpoint analyses.||percentage of participants||95% Confidence Interval|Number
786716|NCT00846846|Primary|To Evaluate Overall Stent Thrombosis Rate of the Endeavor® Zotarolimus Eluting Coronary Stent System in a Patient Population Requiring Stent Implantation|The primary endpoint rate of ARC-defined definite or probable stent thrombosis at 3 years.|3 years|Of the one thousand and eighteen (1018) ITT patients, a total of nine hundred and forty seven (947) patients were included in the primary endpoint analysis. These patients had at least 1050 days of follow-up or had experienced stent thrombosis prior to 1080 days.||percentage of participants||95% Confidence Interval|Number
786717|NCT00846885|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
786718|NCT00846885|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
786719|NCT00846885|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Cmax.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
786720|NCT00847002|Secondary|Reduction in Leg Volume||12 weeks|The study was stopped early due to lack of enrollment statistical analysis was not completed.|||||
786721|NCT00847002|Primary|Wound Healing||12 weeks|The study was stopped early due to lack of enrollment statistical analysis was not completed.|||||
786722|NCT00847015|Secondary|The Time to Disease Progression in Patients With Muscle Invasive Urothelial Carcinoma of the Bladder Treated With Neoadjuvant GCS Followed by Radical Cystectomy.|The time to disease progression is measured from the time of initiation of chemotherapy until the first date that systemic recurrence is objectively documented. Systemic recurrence for this trial is defined as either metastatic or local pelvic recurrence.|2 years|||months||95% Confidence Interval|Median
786723|NCT00847015|Secondary|The Pathologic Response Rate (<pT2) of Neoadjuvant GCS Regimen in Patients With Muscle-invasive Bladder Cancer.|is defined as the absence of muscle invasive carcinoma (<pT2 disease) and the absence of microscopic lymph node metastases (N0) on the final cystectomy specimen.|2 years|||percentage of participants||95% Confidence Interval|Number
786724|NCT00847015|Primary|The Pathologic Complete Response Rate (<pT0) of Neoadjuvant GCS Regimen in Patients With Muscle-invasive Bladder Cancer.|Complete pathologic response to neoadjuvant GCS is the primary endpoint is defined as the absence of carcinoma (pT0 disease) and the absence of microscopic lymph node metastases (N0) on the final cystectomy specimen.|2 years|||percentage of participants||95% Confidence Interval|Number
786725|NCT00847132|Secondary|Change in Depression Symptoms From Baseline to 6 Months|Depression symptoms measured by the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a 9-item scale that measures depression severity. Each question asks how often the subject experiences symptoms of depression and offers four answers: 0 = Not at all, 1 = Several days, 2 = More than half the days, 3 = Nearly every day. Scores are totaled and range from 0-27. To be considered depressed, subjects had to (a) have a total score of 10 or more, (b) answer five questions with a score of 2 or 3, and (c) one of the five questions had to be question 1 or question 2 (or both). Anyone who did not meet these criteria were not considered depressed.|Baseline, 6 weeks, 12 weeks, 6 months|||units on a scale||95% Confidence Interval|Mean
786726|NCT00847132|Primary|Rates of Adequate Depression Treatment at Discharge|"Adequate treatment was defined a priori as either: (1) discharge prescription of an antidepressant at a clinically effective dose based on manufacturers’ package labeling and treatment guidelines for the treatment of depression or (2) referral to a mental health treatment provider for psychotherapy (unless pre-planned as less than six sessions).
Timeframe of 5 days after enrollment was determined by calculating the median length of hospitalization for all subjects."|5 days after enrollment|||percentage of participants|||Number
786727|NCT00847145|Secondary|Number of Subjects Reporting Solicited Systemic Reactions During 8-28 Days Following MMRV Vaccination at 12 Months of Age|Safety was assessed as the number of subjects who reported solicited systemic reactions from day 8 through day 28 after the MMRV vaccination concomitantly with rMenB+OMV NZ at 12 months of age (groups 12B12M, 12M12B14B, 12B12M_C) or after MMRV vaccination alone without rMenB+OMV NZ at 12 months (Group 12M13B15B). For the safety analysis purpose, Groups 12B12M (1a) and 12B12M (3a) are combined as Group 12B12M.|From day 8 to day 28 after MMRV vaccination.|Analysis performed on the Safety population.||Subjects|||Number
786728|NCT00847145|Secondary|Number of Subjects Reporting Solicited Local Reactions During the 7 Days Following MMRV Vaccination at 12 Months of Age|Safety was assessed as the number of subjects who reported solicited local reactions from day 1 through day 7 after the MMRV vaccination concomitantly with rMenB+OMV NZ at 12 months of age (groups 12B12M, 12M12B14B, 12B12M_C) or after MMRV vaccination alone without rMenB+OMV NZ at 12 months (Group 12M13B15B). For the safety analysis purpose, Groups 12B12M (1a) and 12B12M (3a) are combined as Group 12B12M.|From day 1 to day 7 after MMRV vaccination.|Analysis performed on the Safety population.||Subjects|||Number
786729|NCT00847145|Secondary|Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination|Safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 through day 7 after rMenB+OMV NZ vaccination administered with a two-dose catch-up schedules (groups 12M13B15B and 12M12B14B).|From day 1 to day 7 after each rMenB+MV NZ vaccination.|Analysis performed on the Safety population.||Subjects|||Number
786780|NCT00847613|Other Pre-specified|Association Between Genomic and Metabonomic Variation||Month 24||02/2013||||
787088|NCT00840099|Primary|Bioequivalence Based on AUC0-inf for Clavulanic Acid|AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)|Blood samples collected over 14 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
786730|NCT00847145|Secondary|Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age|Safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 through day 7 after rMenB+OMV NZ vaccination administered at 12 months. For the safety analysis purpose, Groups 12B12M (1a) and 12B12M (3a) are combined as Group 12B12M and Groups 12B13M (1b) and 12B13M (3b) are combined as Group 12B13M.|From day 1 to day 7 after each rMenB+OMV NZ vaccination.|Analysis performed on the Safety population.||Subjects|||Number
786731|NCT00847145|Secondary|Percentages of Subjects With Bactericidal Titers ≥ 1:5 (95% CI) Against Strain M10713 One Month After the Fourth (Booster) Dose Given at 12 Months|The immune response was measured as percentages of subjects with SBA ≥ 1:5 (95% CI) against strain M10713, one month after the fourth (booster) dose given at 12 months of age (groups 12B12M (1a), 12B13M (1b).|One month after the fourth (booster) dose.|The analysis was done on the SBA PP Booster population.||Percentages of Subjects||95% Confidence Interval|Number
786732|NCT00847145|Secondary|ELISA Geometric Mean Concentration Against Vaccine Antigen 287-953 After Two-dose Catch-up in Toddlers|The immune response against vaccine antigen 287-953was measured by ELISA one month after the first dose and one month after the second dose of a two-dose catch-up regimens (12M13B15B and 12M12B14B) in toddlers.|One month after the first dose and one month after the second dose.|The analysis was done on the SBA PP Catch-up population.||IU/mL||95% Confidence Interval|Geometric Mean
786733|NCT00847145|Secondary|ELISA Geometric Mean Concentration Against Vaccine Antigen 287-953 One Month After the Fourth (Booster) Dose Given at 12 Months|The immune response against vaccine antigen 287-953 was measured by ELISA, one month after the fourth (booster) dose given at 12 months of age (groups 12B12M (1a), 12B13M (1b).|One month after the fourth (booster) dose.|The analysis was done on the SBA PP Booster population.||IU/mL||95% Confidence Interval|Geometric Mean
786734|NCT00847145|Secondary|Percentages of Subjects With SBA Titers ≥1:5 After a Two-dose Catch-up Schedule or Two-dose Schedule|The immunogenicity of a two-dose catch-up schedule of rMenB+OMV NZ given at 13 and 15 months (12M13B15B) or 12 and 14 months (12M12B14B) to naïve toddlers was assessed as percentages of subjects with SBA titers ≥1:5 one month after the second dose.|One month after the second dose.|||Percentages of Subjects||95% Confidence Interval|Number
786735|NCT00847145|Secondary|SBA GMTs After a Two-dose Catch-up Schedule or Two-dose Schedule|The immunogenicity of a two-dose catch-up schedule of rMenB+OMV NZ given at 13 and 15 months (12M13B15B) or 12 and 14 months (12M12B14B) to naïve toddlers was assessed by SBA GMTs one month after the second dose.|One month after the second dose.|The analysis was done on the SBA PP Catch-up population.||Titers||95% Confidence Interval|Geometric Mean
786736|NCT00847145|Secondary|Geometric Mean Titers After Receiving the Booster Dose and Single Dose of rMen+OMV NZ Vaccination (Induction of Immunological Memory)|The immunogenicity was assessed to demonstrate the induction of immunological memory in subjects who were previously received three doses of rMenB+OMV NZ as measured by SBA GMT response in comparison to the fourth dose of rMenB+OMV NZ at 12 months of age ( 12B12M(1a) group) to the response in subjects (12M12B14B 0 who received a single dose of rMenB+OMV NZ vaccine.|one month after booster (fourth) dose vaccination and pre-fourth dose vaccination|This analysis was done on the PP population.||Titers||95% Confidence Interval|Geometric Mean
786737|NCT00847145|Secondary|Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Previously Receiving the Three Doses of rMenB+OMV NZ Vaccination (Persistence)|Immunogenicity was assessed to evaluate the persistence in terms of percentages of subjects with hSBA titers ≥ 1:5, previously received three doses of rMenB+OMV NZ directed against N meningitidis serogroup B reference strains H44/76, NZ98/254 and 5/99.|One month post vaccination and pe-booster (fourth) dose vaccination|The analysis was done on PP population.||Percentages of subjects||95% Confidence Interval|Number
786738|NCT00847145|Secondary|Geometric Mean Titers at 12 Months of Age (Predose 4) After Previously Receiving the Three Doses of rMenB+OMV NZ (Persistence)|The immunogenicity was assessed as the persistence of bactericidal antibodies at 12 months of age (pre-dose 4) who previously received three doses of rMenB+OMV NZ in the parent study as measured by hSBA GMTs directed against N meningitidis serogroup B reference strains H44/76, NZ98/254 and 5/99.|one month after third vaccination and pre dose fourth (booster) vaccination|||Titers||95% Confidence Interval|Geometric Mean
786739|NCT00847145|Secondary|The Geometric Mean Titers After Receiving the Booster Dose of rMenB+OMV NZ Vaccination|The human serum bactericidal antibody (hSBA) titer responses, one month after receiving booster dose or rMenB+OMV NZ vaccination, are reported as geometric mean titers (GMTs).|one month after booster (fourth) vaccination.|This analysis was done on PP population.||Titers||95% Confidence Interval|Geometric Mean
786740|NCT00847145|Secondary|Percentages of Subjects With Antibody Response After Receiving the MMRV Vaccination|"Immunogenicity was assessed to demonstrate non-inferiority in terms of percentages of subjects as measured by antibody responses against MMRV vaccine when given concomitantly with the booster (fourth) dose of rMenB+OMV NZ vaccine at 12 months of age when compared to MMRV vaccine when given alone.
The specified cut-off levels for the vaccine antigens : for measles antigen is ≥255mIU/mL, Mumps antigen is ≥10 Enzyme Linked Immunosorbent Assay(ELISA) Antibody(Ab) units, Rubella antigen is ≥10 IU/mL, Varicella antigen is ≥1.25 glycoprotein (gp) ELISA units/ml (seroconversion) and varicella antigen is ≥5 gp ELISA units/ml (seroprotection."|one month after booster (fourth) dose|This analysis was done on Per Protocol (PP) population.||Percentages of subjects||95% Confidence Interval|Number
786741|NCT00847145|Primary|Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Receiving the Booster Dose of rMenB+OMV NZ Vaccination|Immunogenicity was assessed in terms of the percentage of subjects as measured by serum bactericidal antibody titers ≥1:5 the lower limit of the two-sided 95% confidence interval (CI) was ≥75%, directed against N.meningitidis serogroup B reference strains H44/76-SL , NZ98/254, 5/99, one month after the booster (fourth) dose of meningococcal B vaccine with or without the concomitant Measles, Mumps, Rubella, Varicella (MMRV) vaccine in toddlers who were previously vaccinated with three doses of Meningococcal B vaccine.|one month after the booster (fourth) dose|The analysis was done on Per Protocol (PP) population – subjects who received all doses of vaccine in parent & present study, provided evaluable serum samples at 1 month after booster dose or 1 month after 2nd dose, blood draw at 1 month after 3rd injection at 6 months in parent & visit 1 blood draw in present study, had no major protocol violation||Percentages of subjects||95% Confidence Interval|Number
786743|NCT00847197|Primary|Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) (mg/dL)||Baseline and Week 4|The Full Analysis Set (FAS) population served as the primary population for the analysis of efficacy data. FAS is a subset of all randomized participants with following reasons for exclusion: 1. failure to receive at least 1 dose of study treatment 2. lack of any post-randomization endpoint data subsequent to at least 1 dose of study treatment.||Percent Change||Standard Deviation|Mean
786744|NCT00847197|Primary|Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) (mg/dL)||Baseline and Week 4|The Full Analysis Set (FAS) population served as the primary population for the analysis of efficacy data. FAS is a subset of all randomized participants with following reasons for exclusion: 1. failure to receive at least 1 dose of study treatment 2. lack of any post-randomization endpoint data subsequent to at least 1 dose of study treatment.||Percent Change||Standard Deviation|Mean
786745|NCT00847210|Primary|Apparent Volume of Distribution (Vz/F) Pharmacokinetic Parameter.|Vz/F is the distribution of a drug between plasma and the rest of the body following oral administration, calculated as CL/F divided by λz.|After 7 days of dosing.|All participants who had Vz/F estimated were included in the analysis for this parameter. One participant in the 30 mg group was excluded from the PK analysis because most of the PK samples were not collected, and hence no PK parameters were estimable. There was no imputation for missing values. No statistical tests were performed.||L||Standard Deviation|Mean
786746|NCT00847210|Primary|Terminal Elimination Rate Constant (λz) Pharmacokinetic Parameter.|Terminal elimination rate constant (λz) is the rate at which drugs are eliminated from the body.|After 7 days of dosing.|All participants who had λz estimated were included in the analysis. One participant in the 30 mg group was excluded from the PK analysis because most of the PK samples were not collected, and hence no PK parameters were estimable. There was no imputation for missing values. No statistical tests were performed.||1/hr||Standard Deviation|Mean
786747|NCT00847210|Primary|Oral Clearance (CL/F) Pharmacokinetic Parameter.|CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided AUC(0-24), expressed in L/hr.|After 7 days of dosing.|All participants who had CL/F estimated were included in the analysis. One participant in the 30 mg group was excluded from the PK analysis because most of the PK samples were not collected, and hence no PK parameters were estimable. There was no imputation for missing values. No statistical tests were performed.||liter/hr||Standard Deviation|Mean
786748|NCT00847210|Primary|Terminal Phase Elimination Half-life (T1/2) Pharmacokinetic Parameter.|Terminal Phase Elimination Half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.|After 7 days of dosing.|All participants who had T1/2 estimated were included in the analysis for this parameter. One participant in the 30 mg group was excluded from the PK analysis because most of the PK samples were not collected, and hence no PK parameters were estimable. No statistical tests were performed.||hours||Standard Deviation|Mean
786749|NCT00847210|Primary|AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Postdose Pharmacokinetic Parameter.|AUC(0-24) is measure of Area Under the Curve over the dosing interval (tau) (AUC(0-tau]), where tau is the length of the dosing interval - 24 hours in this study).|After 7 days of dosing.|All participants who had AUC(0-24) estimated were included in the analysis for this parameter. One participant in the 30 mg group was excluded from the PK analysis because most of the PK samples were not collected, and hence no PK parameters were estimable. There was no imputation for missing values.||ng*hr/mL/mg||Standard Deviation|Mean
786750|NCT00847210|Primary|AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration Pharmacokinetic Parameter.|Area Under the Plasma Concentration Versus Time Curve (AUC(0-tlqc)) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]).|After 7 days of dosing.|All participants who had AUC(0-tlqc) estimated were included in the analysis for this parameter. One participant in the 30 mg group was excluded from the PK analysis because most of the PK samples were not collected, and hence no PK parameters were estimable. There was no imputation for missing values.||ng*hr/mL/mg||Standard Deviation|Mean
786751|NCT00847210|Primary|Cmax: Maximum Observed Plasma Concentration Pharmacokinetic Parameter.|Maximum Observed Plasma Concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|After 7 days of dosing.|All participants who had Cmax estimated were included in the analysis for this parameter. One participant in the 30 mg group was excluded from the PK analysis because most of the PK samples were not collected, and hence no PK parameters were estimable. There was no imputation for missing values.||ng/mL||Standard Deviation|Mean
786752|NCT00847210|Primary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) Pharmacokinetic Parameter|Tmax: Time to reach the Maximum Plasma Concentration (Cmax), equal to time (hours) to Cmax, as observed on Day 7.|After 7 days of dosing.|All participants who had Tmax estimated were included in the analysis for this parameter. One participant in the 30 mg group was excluded from the pharmacokinetic (PK) analysis because most of the PK samples were not collected, and hence no PK parameters were estimable. There was no imputation for missing values.||hours||Standard Deviation|Mean
786753|NCT00847288|Secondary|Compare the Time to Initiation of Clinical Action With or Without an OptiVol Threshold Crossing Between Monthly and Quarterly Review of Cardiac Compass Trends With OptiVol||1 year|||months||95% Confidence Interval|Median
786754|NCT00847288|Secondary|Identify Patient Groups Who Are More Likely to Have Clinical Actions Triggered by Monthly Rather Than Quarterly Reviews|The binary outcome of having clinical actions taken (Yes/No) is recorded within one month interval for the monthly review group, and within three months interval for the quarterly review group. To make the endpoints of both groups comparable, data from monthly review group are converted as they were collected quarterly. For example, the month 1, 2 and 3 visits of monthly review group are combined as one visit. If there is at least one action taken in any of these three monthly visits, the action taken variable for the combined visit will be recorded as 'yes'. Unscheduled visits in both groups are lumped to the next quarterly time point.|1 year|||percentage of visits with action|Participants|95% Confidence Interval|Mean
786867|NCT00847704|Primary|Fugl-Meyer Assessment of the Lower Extremity|Gold standard for motor impairment in individuals with stroke. A scale measuring tone, range-of-motion and synergies of the lower limb with a range of 0-34, higher scores referring to improved motor ability. The assessment includes 7 subscales, the scores of which are summed to arrive at a total score.|Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up|||units on a scale||Standard Deviation|Mean
786755|NCT00847288|Secondary|Compare Changes in Subject Self-care Over Time in the Monthly Review Arm vs. Quarterly Review Arm|"There are 3 summary scale scores for the Self-Care of Heart Failure Index (SCHFI) form: self-care maintenance score (Section A), management score (Section B), and confidence score (Section C). Each scale score is standardized to a 0 to 100 range, with 0 indicating the worst and 100 indicating the best performance for each scale score.
Here, changes in each scale score between 6 month follow-up and baseline and between 12 month follow-up and baseline are the secondary outcome measures. Specifically, change at 6 (or 12) month follow-up is calculated as a scale score at 6 (or 12) month follow-up subtracts that at baseline. These changes range from -100 to 100 with 0 indicating no change at all, -100 indicating maximum decrease and 100 indicating maximum increase that is possible from baseline for a self-care scale score."|1 year|"For each component, the subject needs to have baseline and 6 (or 12) month measurements to calculate the changes. Subjects included for the each component are as following:
Maintenance (or Confidence): 720 and 675 for monthly and quarterly arms at 6 mo, respectively, 640 and 588 at 12 mo. Management, 166 and 141 at 6 mo, 166 and 104 at 12 mo."||units on a scale||Standard Deviation|Mean
786756|NCT00847288|Primary|Compare the Time to Initiation of Clinical Action Prompted by an OptiVol Threshold Crossing Between Monthly and Quarterly Review of Cardiac Compass Trends With OptiVol||1 year|All patients enrolled in the study, who have eligible study device, signed inform consent, signed HIPAA, and have at least one OptiVol threshold crossing post the start date, were included in this analysis.||months||95% Confidence Interval|Median
786757|NCT00847301|Secondary|Volume of Wound Drainage (Post-operative)|Volume of Wound Drainage after surgery|From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa|Treated set with moderate renal impairment: this patient set included all patients with CrCl 30 - 50 mL/min who received at least one 1 of dabigatran etexilate.||ml||Standard Deviation|Mean
786758|NCT00847301|Secondary|Percentage of Patients With Major Extra-surgical Site Bleedings|Percentage of Patients With Major Extra-surgical Site Bleedings|From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa|Treated set with moderate renal impairment: this patient set included all patients with CrCl 30 - 50 mL/min who received at least one 1 of dabigatran etexilate.||percentage of Participants||95% Confidence Interval|Number
786759|NCT00847301|Primary|Percentage of Patients With Symptomatic Venous Thromboembolic Events (sVTE) and All Cause Mortality|The co-primary efficacy variable sVTE was defined as the composite of documented symptomatic proximal and distal deep vein thrombosis (DVT) and documented symptomatic non-fatal pulmonary embolism (PE) and All Cause Mortality.|From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa|Treated set with moderate renal impairment: this patient set included all patients with CrCl 30 - 50 mL/min who received at least one 1 of dabigatran etexilate.||percentage of Participants||95% Confidence Interval|Number
786760|NCT00847301|Primary|Percentage of Patients With Major Bleeding Events (MBE)|Major bleeding events were defined according to the modified McMaster criteria, and were classified by the investigator as Major bleeding event or Any bleeding event. The criteria for MBE's were: fatal; clinically overt associated with loss of haemoglobin >=20g/L in excess of what was expected; clinically overt leading to the transfusion of >=2 units packed cells or whole blood in excess of what was expected; symptomatic retroperitoneal, intracranial, intraocular or intraspinal; requiring treatment cessation; leading to re-operation|From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa|Treated set with moderate renal impairment: this patient set included all patients with CrCl 30 - 50 mL/min who received at least one 1 of dabigatran etexilate.||percentage of participants||95% Confidence Interval|Number
786761|NCT00847301|Secondary|Documented Symptomatic Proximal DVT, Documented Symptomatic Distal DVT, Documented Symptomatic Nonfatal Pulmonary Embolism and All-cause Mortality|Percentage of participant with documented symptomatic proximal DVT (deep vein thrombosis), documented symptomatic distal DVT, documented symptomatic nonfatal pulmonary embolism and all-cause mortality|From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa|Treated set with moderate renal impairment: this patient set included all patients with CrCl 30 - 50 mL/min who received at least one 1 of dabigatran etexilate.||percentage of participants||95% Confidence Interval|Number
786762|NCT00847405|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
786763|NCT00847405|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
786764|NCT00847405|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Cmax.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
786765|NCT00847509|Primary|[F-18]FLT PET Scan for Early Assessment of Tumor Response to Radiation or Chemoradiotherapy Compared to [F-18] FDG PET Scan|The sponsor decided not to further develop [F-18]FLT. Therefore, no further analysis was performed.|3-5 weeks after the start of radiation or chemo radio therapy||||||
786766|NCT00847535|Primary|Number of Participants That Experienced AMDC Product-related Adverse Events|"If an immune response after injection or any urinary retention occurred and seemed suspicious, the physicians were consulted to determine whether the effect was likely related to the AMDC product.
No adverse events reported during the study were adjudicated as AMDC product-related."|12 months|||participants|||Number
786767|NCT00847535|Primary|Injection Procedure-related Adverse Events|"AMDC treatment was administered via intrasphincteric injection. Injection procedure-related events were defined as systemic responses to the injection procedure or genitourinary events occurring within 30 days of the injection procedure that could be attributed to cystoscopy or catheterization. Since these events could be attributed to the injection procedure, results are considered independent of AMDC dose received.
All injection procedure-related events self-resolved or were easily treated."|30 days|||Number of events|||Number
786768|NCT00847535|Primary|Number of Participants That Experienced Injection Procedure-related Adverse Events|"AMDC treatment was administered via intrasphincteric injection. Injection procedure-related events were defined as systemic responses to the injection procedure or genitourinary events occurring within 30 days of the injection procedure that could be attributed to cystoscopy or catheterization. Since these events could be attributed to the injection procedure, results are considered independent of AMDC dose received.
All injection procedure-related events self-resolved or were easily treated."|30 days|Sixty-four patients underwent intrasphincteric injection of AMDC.||participants|||Number
786769|NCT00847535|Primary|Biopsy Procedure-related Adverse Events|"Biopsy was required to generate AMDC products. Biopsy procedure-related events were defined as systemic responses to the biopsy procedure or injury at the biopsy site. Since biopsy occurred prior to AMDC treatment, results are presented independent of AMDC dose received.
All biopsy procedure-related events either self-resolved or were easily treated."|at biopsy or between biopsy and treatment|||Number of events|||Number
786770|NCT00847535|Primary|Number of Participants That Experienced Biopsy Procedure-related Adverse Events|"Biopsy was required to generate AMDC products. Biopsy procedure-related events were defined as systemic responses to the biopsy procedure or injury at the biopsy site. Since biopsy occurred prior to AMDC treatment, results are presented independent of AMDC dose received.
All biopsy procedure-related events either self-resolved or were easily treated."|at biopsy or between biopsy and treatment|During the study, 66 patients underwent a total of 78 biopsies.||participants|||Number
786771|NCT00847561|Primary|Anxiety Disorders Interview Schedule for Diagnostic and Statistical Manual for Psychological Disorders-IV, Child and Parent Versions (C/P-ADIS)|"The C/P-ADIS is a semi-structured diagnostic interview used to assess symptoms of anxiety, depression, and behavioral issues.
This interview will be administered by a trained staff member and will utilize information from both parents and children.
This interview will be used to determine the presence or absence of an anxiety disorder for children in this study."|12 months post-treatment|||participants with anxiety diagnosis|||Number
786772|NCT00847587|Secondary|Crematocrit of Human Milk|Determination of creamatocrit is a simple method for estimating the fat & energy content of human milk based on the centrifugation of milk in a hematocrit centrifuge. The method for creamatocrit measurement was as described by Lucas et al (LucasA, GibbsJA, LysterRL, BaumJD. Creamatocrit: simple clinical technique for estimating fat concentration and energy value of human milk. BritMedJnl1978;1:1018-20)using a standard hematocrit centrifuge, standard hematocrit glass capillary tube, & vernier calipers. Measurements were performed in duplicate and the mean for each measurement used for analysis.|6 weeks postpartum|Both intent-to-treat and per-protocol analyses were performed. Per-protocol analysis is presented to demonstrate the more conservative analysis for the primary outcomes in a noninferiority study.||Percent creamatocrit||Standard Deviation|Mean
786773|NCT00847587|Primary|Time to Lactogenesis Stage II|The primary outcome, time to lactogenesis stage II in hours, was documented by maternal perception as previously described and validated in the literature. Subjects were asked, “Has your milk come in? Some women experience this as a prickly feeling or tingling in the breast, dripping from the other nipple when nursing, milk running from the baby’s mouth, or gulping by the baby. ” If the response was positive, subjects were then asked, “When did your milk come in?” and the response recorded to the nearest hour.|5 days postpartum|||hours||Standard Deviation|Mean
786774|NCT00847613|Secondary|Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 12, 18 and 24|Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance.|Month 12, 18, 24|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. Data for time points after Month 12 shall be reported after completion of the end-of-study analysis.||units on a scale||Standard Deviation|Mean
786775|NCT00847613|Secondary|Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 6|Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance.|Baseline, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
786776|NCT00847613|Other Pre-specified|Change From Baseline in Body Temperature at Month 1, 3, 6, 9, 12, 15, 18, 21 and 24||Baseline, Month 1, 3, 6, 9, 12, 15, 18, 21, 24|Data for this pre-specified outcome measure was collected and reported in individual participant listings as per planned analysis but not statistically summarized.|||||
786777|NCT00847613|Other Pre-specified|Change From Baseline in Heart Rate at Month 1, 3, 6, 9, 12, 15, 18, 21 and 24||Baseline, Month 1, 3, 6, 9, 12, 15, 18, 21, 24|Data for this pre-specified outcome measure was collected and reported in individual participant listings as per planned analysis but not statistically summarized.|||||
786778|NCT00847613|Other Pre-specified|Change From Baseline in Blood Pressure (BP) at Month 9, 12, 15, 18, 21 and 24|BP: pressure exerted by the blood upon the walls of the blood vessels and especially arteries, usually measured on the radial artery using a sphygmomanometer. Systolic BP: the highest arterial blood pressure of a cardiac cycle occurring immediately after systole of the left ventricle of the heart. Diastolic BP: the lowest arterial blood pressure of a cardiac cycle occurring during diastole of the heart.|Baseline, Month 9, 12, 15, 18, 21, 24|Safety analysis set: all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed)=participants evaluable for the measure. 'n'=participants evaluable at given time points for each group respectively. Data for time points after Month 12 will be reported after completion of end-of-study analysis.||mmHg||Standard Deviation|Mean
786779|NCT00847613|Other Pre-specified|Change From Baseline in Blood Pressure (BP) at Month 1, 3 and 6|BP: pressure exerted by the blood upon the walls of the blood vessels and especially arteries, usually measured on the radial artery using a sphygmomanometer. Systolic BP: the highest arterial blood pressure of a cardiac cycle occurring immediately after systole of the left ventricle of the heart. Diastolic BP: the lowest arterial blood pressure of a cardiac cycle occurring during diastole of the heart.|Baseline, Month 1, 3, 6|Safety analysis set: all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed)=participants evaluable for the measure. 'n'=participants evaluable at given time points for each group respectively. Data for time points after Month 12 will be reported after completion of end-of-study analysis.||millimeters of mercury (mmHg)||Standard Deviation|Mean
786781|NCT00847613|Other Pre-specified|Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 at Month 9, 12, 15, 18, 21 and 24|DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Month 9, 12, 15, 18, 21, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.||percentage of participants|||Number
786782|NCT00847613|Other Pre-specified|Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 at Month 1, 3 and 6|DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method.||percentage of participants|||Number
786783|NCT00847613|Other Pre-specified|Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than or Equal to 3.2 at Month 9, 12, 15, 18, 21 and 24|DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Month 9, 12, 15, 18, 21, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.||percentage of participants|||Number
786784|NCT00847613|Other Pre-specified|Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than or Equal to 3.2 at Month 1, 3 and 6|DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method.||percentage of participants|||Number
786785|NCT00847613|Other Pre-specified|Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 9, 12, 15, 18, 21 and 24|DAS28-4 (ESR) was calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Month 9, 12, 15, 18, 21, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.||percentage of participants|||Number
786786|NCT00847613|Other Pre-specified|Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 1, 3 and 6|DAS28-4 (ESR) was calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method.||percentage of participants|||Number
786787|NCT00847613|Other Pre-specified|Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than or Equal to 3.2 at Month 9, 12, 15, 18, 21 and 24|DAS28-4 (ESR) was calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Month 9, 12, 15, 18, 21, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.||percentage of participants|||Number
786788|NCT00847613|Other Pre-specified|Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than or Equal to 3.2 at Month 1, 3 and 6|DAS28-4 (ESR) was calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method.||percentage of participants|||Number
786789|NCT00847613|Other Pre-specified|Percentage of Participants With Sustained Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6|DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission. Participants with sustained DAS28-4 (ESR) response less than 2.6 for 2, 3, 4 and 5 consecutive visits were analyzed up to Month 12.|Baseline through Month 12, Month 24|FAS population. Data up to Month 12 reported. For time period after Month 12, data will be reported after completion of the end-of-study analysis.||percentage of participants|||Number
786790|NCT00847613|Other Pre-specified|Percentage of Participants With Sustained Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6|DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission. Participants with sustained DAS28-3 (CRP) response less than 2.6 for 2, 3, 4 and 5 consecutive visits were analyzed up to Month 12.|Baseline through Month 12, Month 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data up to Month 12 reported. For time period after Month 12, data will be reported after completion of the end-of-study analysis.||percentage of participants|||Number
786791|NCT00847613|Other Pre-specified|Percentage of Participants With Sustained American College of Rheumatology 70% (ACR70) Response|ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP. Participants with sustained ACR70 response for 2, 3, 4 and 5 consecutive visits were analyzed up to Month 12.|Baseline through Month 12, Month 24|FAS population: all randomized participants who received at least 1 dose of study medication. Data up to Month 12 reported. For time period after Month 12, data will be reported after completion of the end-of-study analysis.||percentage of participants|||Number
786792|NCT00847613|Other Pre-specified|Percentage of Participants With Sustained American College of Rheumatology 50% (ACR50) Response|ACR50 response: >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP. Participants with sustained ACR50 response for 2, 3, 4 and 5 consecutive visits were analyzed up to Month 12.|Baseline through Month 12, Month 24|FAS population: all randomized participants who received at least 1 dose of study medication. Data up to Month 12 reported. For time period after Month 12, data will be reported after completion of the end-of-study analysis.||percentage of participants|||Number
786793|NCT00847613|Other Pre-specified|Percentage of Participants With Sustained American College of Rheumatology 20% (ACR20) Response|ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP. Participants with sustained ACR20 response for 2, 3, 4 and 5 consecutive visits were analyzed up to Month 12.|Baseline through Month 12, Month 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data up to Month 12 reported. For time period after Month 12, data will be reported after completion of the end-of-study analysis.||percentage of participants|||Number
786794|NCT00847613|Secondary|Number of Hours Per Day as Assessed RA-HCRU at Month 12, 18 and 24|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported.|Month 12, 18, 24|FAS. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.||hours per day||Standard Deviation|Mean
786795|NCT00847613|Secondary|Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported.|Baseline, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.||hours per day||Standard Deviation|Mean
786796|NCT00847613|Secondary|Number of Days as Assessed Using RA-HCRU at Month 12, 18 and 24|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains.Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.|Month 12, 18, 24|FAS. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.||days||Standard Deviation|Mean
786797|NCT00847613|Secondary|Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains.Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.|Baseline, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.||days||Standard Deviation|Mean
786798|NCT00847613|Secondary|Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.|Month 12, 18, 24|FAS. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.||events||Standard Deviation|Mean
786799|NCT00847613|Secondary|Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.|Baseline, Month 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.||events||Standard Deviation|Mean
786800|NCT00847613|Secondary|Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24|Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost:visit to doctor,non-medical practitioner,nursing home,hospital,surgery,emergency room(ER) treatment,diagnostic tests, over-night stay,home healthcare services, aids/devices used. Indirect costs associated with functional disability:employment status,willingness to work,work disability due to RA,sick leave,part time work,ability to perform chores,chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale;higher score=higher medical cost.|Month 12, 18, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively. Data for time points after Month 12 shall be reported after completion of the end-of-study analysis.||units on a scale||Standard Deviation|Mean
786801|NCT00847613|Secondary|Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6|Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, non-medical practitioner, nursing home, hospital, surgery, emergency room(ER) treatment, diagnostic tests, over-night stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family, friends or housekeeper. Assessment was based on 0 to 2-point scale; higher score=higher medical cost.|Baseline, Month 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
786802|NCT00847613|Secondary|Work Limitations Questionnaire (WLQ) Score at Month 12, 18 and 24|WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0[no loss] to 100[complete loss of work]).|Month 12, 18, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.||units on a scale||Standard Deviation|Mean
786803|NCT00847613|Secondary|Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6|WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0[no loss] to 100[complete loss of work]).|Baseline, Month 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
786804|NCT00847613|Secondary|Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Month 12, 18 and 24|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Month 12, 18, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data reported for Month 12. For time points after Month 12, data will be reported after completion of the end-of-study analysis.||units on a scale||Standard Deviation|Mean
786822|NCT00847613|Secondary|Modified Total Sharp Scores (mTSS) at Month 12 and 24|mTSS = sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Month 12, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data for Month 24 will be reported after completion of the end-of-study analysis.||units on a scale||Standard Deviation|Mean
786805|NCT00847613|Secondary|Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Baseline, Month 3 and 6|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Baseline, Month 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
786806|NCT00847613|Secondary|Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 12, 18 and 24|FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.|Month 12, 18, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data reported for Month 12. For time points after Month 12, data will be reported after completion of the end-of-study analysis.||units on a scale||Standard Deviation|Mean
786807|NCT00847613|Secondary|Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline, Month 1, 3, and 6|FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.|Baseline, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
786808|NCT00847613|Secondary|Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24|MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported.|Month 12, 18, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data reported for Month 12. For time points after Month 12, data will be reported after completion of the end-of-study analysis.||participants|||Number
786809|NCT00847613|Secondary|Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24|Participant-rated 12 item questionnaire to assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no). 9 item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score(RS) minus lowest possible score divided by possible RS range*100);total score range:0-100,higher score=more intensity of attribute.|Month 12, 18, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.||units on a scale||Standard Deviation|Mean
786810|NCT00847613|Secondary|Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6|MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported.|Baseline, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.||participants|||Number
786811|NCT00847613|Secondary|Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6|Participant-rated 12 item questionnaire to assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no). 9 item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score(RS) minus lowest possible score divided by possible RS range*100);total score range:0-100,higher score=more intensity of attribute.|Baseline, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
786823|NCT00847613|Secondary|Modified Total Sharp Scores (mTSS) at Baseline|mTSS = sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Baseline|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
786812|NCT00847613|Secondary|36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.|Month 9, 12, 15, 18, 21, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.||units on a scale||Standard Deviation|Mean
786813|NCT00847613|Secondary|36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.|Baseline, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
786814|NCT00847613|Secondary|Physician Global Assessment (PGA) of Arthritis at Month 9, 12, 15, 18, 21 and 24|Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.|Month 9, 12, 15, 18, 21, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.||mm||Standard Deviation|Mean
786815|NCT00847613|Secondary|Physician Global Assessment (PGA) of Arthritis at Baseline, Month 1, 3 and 6|Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.|Baseline, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.||mm||Standard Deviation|Mean
786816|NCT00847613|Secondary|Patient Global Assessment (PtGA) of Arthritis Pain at Month 9, 12, 15, 18, 21 and 24|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS where 0 = very well and 100 = very poorly."|Month 9, 12, 15, 18, 21, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.||mm||Standard Deviation|Mean
786817|NCT00847613|Secondary|Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Month 1, 3, and 6|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS where 0 = very well and 100 = very poorly."|Baseline, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.||mm||Standard Deviation|Mean
786818|NCT00847613|Secondary|Patient Assessment of Arthritis Pain at Month 9, 12, 15, 18, 21 and 24|Participants rated the severity of arthritis pain on a 0 to 100 mm visual analogue scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.|Month 9, 12, 15, 18, 21, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.||mm||Standard Deviation|Mean
786819|NCT00847613|Secondary|Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 and 6|Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) visual analogue scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.|Baseline, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.||mm||Standard Deviation|Mean
786820|NCT00847613|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 9, 12, 15, 18, 21 and 24|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0=least difficulty and 3=extreme difficulty.|Month 9, 12, 15, 18, 21, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.||units on a scale||Standard Deviation|Mean
786821|NCT00847613|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Month 1, 3 and 6|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0=least difficulty and 3=extreme difficulty.|Baseline, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
786864|NCT00847704|Secondary|Spasticity (Modified Ashworth) Scale|Measure of the total Ashworth scoring for increased muscle tone in the ankle flexors, ankle extensors, knee flexors, and knee extensors in the affected leg of stroke subjects. The scale range is from 0-5, with higher levels representing more exaggerated tone.|Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up|||units on a scale||Standard Deviation|Mean
786824|NCT00847613|Secondary|Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR])|DAS28-3 (ESR) was calculated from the number of SJC and TJC using the 28 joints count and ESR (mm/hr). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (ESR) <=3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Baseline, Month 1, 3, 6, 9, 12, 15, 18, 21, 24|Since DAS28-3 (ESR) was determined to provide no new information over DAS28-4 (ESR) and DAS28-3 (CRP), there was a change in planned analysis and data was not analyzed for DAS28-3 (ESR).|||||
786825|NCT00847613|Secondary|Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])|DAS28-4 (CRP) was calculated from SJC and TJC using the 28 joints count, CRP [mg/L] and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 [CRP] <=3.2 implied low disease activity, DAS28-4 [CRP] >3.2 to 5.1 implied moderate to high disease activity and DAS28 <2.6 implied remission.|Baseline, Month 1, 3, 6, 9, 12, 15, 18, 21, 24|Since DAS28-4 (CRP) was determined to provide no new information over DAS28-4 (ESR) and DAS28-3 (CRP), there was a change in planned analysis and data was not analyzed for DAS28-4 (CRP).|||||
786826|NCT00847613|Secondary|Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 9, 12, 15, 18, 21 and 24|DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Month 9, 12, 15, 18, 21, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.||units on a scale||Standard Deviation|Mean
786827|NCT00847613|Secondary|Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 1, 3 and 6|DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Baseline, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
786828|NCT00847613|Secondary|Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9, 12, 15, 18, 21 and 24|DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 indicated low disease activity, >3.2 to 5.1 indicated moderate to high disease activity and <2.6 = remission.|Month 9, 12, 15, 18, 21, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.||units on a scale||Standard Deviation|Mean
786829|NCT00847613|Secondary|Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Month 1, 3 and 6|DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Baseline, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
786830|NCT00847613|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 9, 12, 15, 18, 21 and 24|ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.|Month 9, 12, 15, 18, 21, 24|FAS population. 'N' (number of participants analyzed)signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method. Data for time points after Month 12 shall be reported after completion of the end-of-study analysis.||percentage of participants|||Number
786831|NCT00847613|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 1, 3 and 6|ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.|Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed)signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method.||percentage of participants|||Number
786832|NCT00847613|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 9, 12, 15, 18, 21 and 24|ACR50 response: greater than or equal to >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.|Month 9, 12, 15, 18, 21, 24|FAS population. 'N' (number of participants analyzed)signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method. Data for time points after Month 12 shall be reported after completion of the end-of-study analysis.||percentage of participants|||Number
786833|NCT00847613|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 1, 3 and 6|ACR50 response: greater than or equal to >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.|Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed)signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method.||percentage of participants|||Number
786834|NCT00847613|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 9, 12, 15, 18, 21 and 24|ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.|Month 9, 12, 15, 18, 21, 24|FAS population. 'N' (number of participants analyzed)signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method. Data for time points after Month 12 shall be reported after completion of the end-of-study analysis.||percentage of participants|||Number
786835|NCT00847613|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 1 and 3|ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.|Month 1, 3|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method.||percentage of participants|||Number
786836|NCT00847613|Primary|Percentage of Participant With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 6|DAS28-4 (ESR) calculated from swollen joint count (SJC) and tender/painful joint count (TJC) using 28 joint count, erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) less than or equal to (=<) 3.2 implied low disease activity, greater than (>) 3.2 to 5.1 implied moderate to high disease activity and less than (<) 2.6=remission. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.|Month 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method.||percentage of participants|||Number
786837|NCT00847613|Primary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, reach, grip, hygiene and common activities over past week. Each item scored on 4-point scale, 0 to 3: 0=no difficulty; 1=some difficulty;2=much difficulty; 3=unable to do. Overall score was computed as sum of domain sc ores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis.|Baseline, Month 3|FAS included all randomized participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
786838|NCT00847613|Primary|Changes From Baseline in Modified Total Sharp Score (mTSS) at Month 6|mTSS = sum of erosion and Joint Space Narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change: scores at observation minus score at baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.|Baseline, Month 6|Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Error|Least Squares Mean
786839|NCT00847613|Primary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6|ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP). For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.|Month 6|Full Analysis Set (FAS): all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using Non-responder Imputation (NRI) method.||percentage of participants|||Number
786840|NCT00847626|Secondary|Percentage of Participants Who Achieve Both a Clinic Systolic and Diastolic Blood Pressure Response at Week 8.|Percentage of participants who achieve both a clinic systolic and diastolic blood pressure response measured at week 8, defined as systolic blood pressure less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg AND diastolic blood pressure less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg . Systolic/diastolic blood pressure is based on the average of the 3 serial trough clinic sitting systolic/diastolic blood pressure measurements.|Baseline and Week 8.|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.||percentage of participants|||Number
786841|NCT00847626|Secondary|Percentage of Participants Who Achieve a Clinic Diastolic Blood Pressure Response at Week 8, Defined as Clinic Diastolic Blood Pressure <90 mm Hg and/or a Reduction of ≥10 mm Hg From Baseline.|Percentage of participants who achieve a clinic diastolic blood pressure response measured at week 8, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg. Diastolic blood pressure is the average of the 3 serial trough sitting clinic diastolic blood pressure measurements.|Baseline and Week 8.|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.||percentage of participants|||Number
786842|NCT00847626|Primary|Change From Baseline to Week 8 in Trough, Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring (Pairwise Analysis)|The change in trough systolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 8.|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
786843|NCT00847626|Secondary|Percentage of Participants Who Achieve a Clinic Systolic Blood Pressure Response at Week 8, as Defined by Clinic Systolic Blood Pressure <140 mm Hg and/or a Reduction of ≥20 mm Hg From Baseline.|Percentage of participants who achieve a clinic systolic blood pressure response measured at week 8, defined as less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Systolic blood pressure is the average of the 3 serial trough sitting clinic systolic blood pressure measurements.|Baseline and Week 8|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.||percentage of participants|||Number
786844|NCT00847626|Secondary|Change From Baseline to Week 8 in the Mean Diastolic Blood Pressure at 0 to 12 Hours After Dosing, as Measured by Ambulatory Blood Pressure Monitoring.|The change in the 12-hour mean diastolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 8.|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
786845|NCT00847626|Secondary|Change From Baseline to Week 8 in the Mean Systolic Blood Pressure at 0 to 12 Hours After Dosing, as Measured by Ambulatory Blood Pressure Monitoring.|The change in the 12-hour mean systolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 8|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
786846|NCT00847626|Secondary|Change From Baseline to Week 8 in the Mean Nighttime (12 AM to 6 AM) Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean diastolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 8.|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
786847|NCT00847626|Secondary|Change From Baseline to Week 8 in the Mean Nighttime (12 AM to 6 AM) Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean systolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 8.|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
786848|NCT00847626|Secondary|Change From Baseline to Week 8 in the Mean Daytime (6 AM to 10 PM) Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean diastolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 8.|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
786849|NCT00847626|Secondary|Change From Baseline to Week 8 in the Mean Daytime (6 AM to 10 PM) Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean systolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 8.|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
786865|NCT00847704|Secondary|Stroke Impact Scale|"The Stroke Impact Scale is a self-assessment questionnaire concerning activities of daily living. There are 8 sub-scales, each of which is summed as a raw score (range of 0-100) and then transformed as follows:
Transformed Scale=[(Actual raw score-lowest possible raw score)/Possible raw score range]x100.
Thus, the maximum possible score for the entire measure is 800. A higher score indicates a higher level of functioning."|Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up|||units on a scale||Standard Deviation|Mean
786850|NCT00847626|Secondary|Change From Baseline to Week 8 in the 24-hour Mean Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring|The change in 24-hour mean diastolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 8.|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
786851|NCT00847626|Secondary|Change From Baseline to Week 8 in the 24-hour Mean Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring|The change in 24-hour mean systolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 8.|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
786852|NCT00847626|Secondary|Change From Baseline to Week 8 in the Mean Trough Diastolic Blood Pressure (22 to 24 Hours After Dosing), as Measured by Ambulatory Blood Pressure Monitoring.|The change in trough diastolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 8.|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
786853|NCT00847626|Secondary|Change From Baseline to Week 8 in Trough, Sitting, Clinic Diastolic Blood Pressure|The change in trough diastolic blood pressure measured at final visit or week 8 relative to baseline. Diastolic blood pressure is the average of the 3 serial trough clinic sitting diastolic blood pressure measurements.|Baseline and Week 8.|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
786854|NCT00847626|Secondary|Change From Baseline to Week 8 in Trough Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring in Black Participants (Pairwise Analysis)|The change in trough systolic blood pressure in black participants as measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 8.|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
786855|NCT00847626|Secondary|Change From Baseline to Week 8 in Trough Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring in Black Participants (Pooled Analysis)|The change in trough systolic blood pressure in black subjects measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 8.|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
786856|NCT00847626|Secondary|Change From Baseline to Week 8 in Trough, Sitting, Clinic Systolic Blood Pressure|The change in trough systolic blood pressure measured at final visit or week 8 relative to baseline. Systolic blood pressure is the arithmetic mean of the 3 serial trough sitting systolic blood pressure measurements.|Baseline and Week 8|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
786857|NCT00847626|Primary|Change From Baseline to Week 8 in Trough, Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring (Pooled Analysis)|The change in trough systolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 8.|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
786858|NCT00847665|Secondary|Length of Mechanical Ventilation (MV)|Time from initiation to withdrawal of mechanical ventilation. Days|ICU length of stay|||days||Inter-Quartile Range|Median
786859|NCT00847665|Secondary|Workload of Nurses|Time actually spent to manual repositioning by nurses team, in minutes/day|icu length of stay|||minutes per day||Inter-Quartile Range|Median
786860|NCT00847665|Secondary|ICU Mortality|ICU mortality (number of death in ICU)|ICU length of stay (an average of 28 days)|||participants|||Number
786861|NCT00847665|Primary|Incidence of Pressure Ulcer (PU) Grade ≥ II|Pressure ulcers were categorized according to the EPUAP-classification system. A grade I PU is non-blanchable erythema, a grade II is an abrasion or blister, a grade III is a superficial ulcer and a grade IV is a deep ulcer|Intensive Care Unit (ICU) length of stay (days)|Intention to treat||participants|||Number
786862|NCT00847704|Secondary|Active Motion Test|Tracking task. Active joint position control between dorsiflexion/plantarflexion (change-score from average of first 3 training sessions and last 3 training sessions). The score is based on the amount of time that the participant is able to position the joint in a 3 deg-wide target zone presented on a video screen.|First 3 training sessions (week 1-2); Last 3 training sessions (week 9-10)|||Seconds||Standard Deviation|Mean
786863|NCT00847704|Secondary|Strength Test|Measurement of ankle dorsiflexion/plantarflexion isometric strength (change-score from average of first 3 training sessions and last 3 training sessions).|First 3 training sessions (week 1-2); Last 3 training sessions (week 9-10)|||Newton meters||Standard Deviation|Mean
786868|NCT00847808|Secondary|Change From Baseline in Patient Assessment of Upper Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM) - Total Score in Participants Who Remain Well-controlled.|PAGI-SYM is a 20-item self-reported questionnaire that measures symptom severity of upper gastrointestinal disorders across six subscales (nausea/vomiting, fullness/early satiety, bloating, upper abdominal pain, lower abdominal pain, heartburn/regurgitation) which are summarized by individual subscale scores and a total score. The items are rated on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (very severe). Higher scores indicate higher symptom severity and thus negative changes from baseline indicate decrease in symptom severity.|Baseline and Week 6.|Values are from the Full Analysis Set.||units on a scale||Standard Deviation|Mean
786869|NCT00847808|Secondary|Change From Baseline in Patient Assessment of Upper Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM) - Heartburn/Regurgitation Subscale in Participants Who Remain Well-controlled.|PAGI-SYM is a 20-item self-reported questionnaire that measures symptom severity of upper gastrointestinal disorders across six subscales (nausea/vomiting, fullness/early satiety, bloating, upper abdominal pain, lower abdominal pain, heartburn/regurgitation) which are summarized by individual subscale scores and a total score. The items are rated on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (very severe). Higher scores indicate higher symptom severity and thus negative changes from baseline indicate decrease in symptom severity.|Baseline and Week 6.|Values are from the Full Analysis Set.||units on a scale||Standard Deviation|Mean
786870|NCT00847808|Secondary|Change From Baseline in Patient Assessment of Upper Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM) - Lower Abdominal Pain Subscale in Participants Who Remain Well-controlled.|PAGI-SYM is a 20-item self-reported questionnaire that measures symptom severity of upper gastrointestinal disorders across six subscales (nausea/vomiting, fullness/early satiety, bloating, upper abdominal pain, lower abdominal pain, heartburn/regurgitation) which are summarized by individual subscale scores and a total score. The items are rated on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (very severe). Higher scores indicate higher symptom severity and thus negative changes from baseline indicate decrease in symptom severity.|Baseline and Week 6.|Values are from the Full Analysis Set.||units on a scale||Standard Deviation|Mean
786871|NCT00847808|Secondary|Change From Baseline in Patient Assessment of Upper Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM) - Upper Abdominal Pain Subscale in Participants Who Remain Well-controlled.|PAGI-SYM is a 20-item self-reported questionnaire that measures symptom severity of upper gastrointestinal disorders across six subscales (nausea/vomiting, fullness/early satiety, bloating, upper abdominal pain, lower abdominal pain, heartburn/regurgitation) which are summarized by individual subscale scores and a total score. The items are rated on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (very severe). Higher scores indicate higher symptom severity and thus negative changes from baseline indicate decrease in symptom severity.|Baseline and Week 6.|Values are from the Full Analysis Set.||units on a scale||Standard Deviation|Mean
786872|NCT00847808|Secondary|Change From Baseline in Patient Assessment of Upper Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM) - Bloating Subscale in Participants Who Remain Well-controlled.|PAGI-SYM is a 20-item self-reported questionnaire that measures symptom severity of upper gastrointestinal disorders across six subscales (nausea/vomiting, fullness/early satiety, bloating, upper abdominal pain, lower abdominal pain, heartburn/regurgitation) which are summarized by individual subscale scores and a total score. The items are rated on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (very severe). Higher scores indicate higher symptom severity and thus negative changes from baseline indicate decrease in symptom severity.|Baseline and Week 6.|Values are from the Full Analysis Set.||units on a scale||Standard Deviation|Mean
786873|NCT00847808|Secondary|Change From Baseline in Patient Assessment of Upper Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM) - Fullness/Early Satiety Subscale in Participants Who Remain Well-controlled.|PAGI-SYM is a 20-item self-reported questionnaire that measures symptom severity of upper gastrointestinal disorders across six subscales (nausea/vomiting, fullness/early satiety, bloating, upper abdominal pain, lower abdominal pain, heartburn/regurgitation) which are summarized by individual subscale scores and a total score. The items are rated on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (very severe). Higher scores indicate higher symptom severity and thus negative changes from baseline indicate decrease in symptom severity.|Baseline and Week 6.|Values are from the Full Analysis Set.||units on a scale||Standard Deviation|Mean
786874|NCT00847808|Secondary|Change From Baseline in Patient Assessment of Upper Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM) - Nausea/Vomiting Subscale in Participants Who Remain Well-controlled.|PAGI-SYM is a 20-item self-reported questionnaire that measures symptom severity of upper gastrointestinal disorders across six subscales (nausea/vomiting, fullness/early satiety, bloating, upper abdominal pain, lower abdominal pain, heartburn/regurgitation) which are summarized by individual subscale scores and a total score. The items are rated on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (very severe). Higher scores indicate higher symptom severity and thus negative changes from baseline indicate decrease in symptom severity.|Baseline and Week 6.|Values are from the Full Analysis Set.||units on a scale||Standard Deviation|Mean
786875|NCT00847808|Secondary|Change From Baseline in the Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QOL) - Total Score in Participants Who Remain Well-controlled.|PAGI-QOL is a 30-item self-reported instrument assessing health-related quality of life impact of upper gastrointestinal disorders. It includes 30 items across five subscales (daily activities, clothing, diet/food habits, relationship, psychological well-being and distress), scored on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (all the time). For reporting purposes, the scores are reversed and higher scores reflect improved quality of life and positive changes from baseline indicate improved quality of life.|Baseline and Week 6.|Values are from the Full Analysis Set.||units on a scale||Standard Deviation|Mean
786895|NCT00848016|Secondary|Progression-free Survival|The progression-free survival is defined as the time from registration to the date of progression or death, whichever comes first. The distributions of progression-free survival time will be estimated using the method of Kaplan-Meier.|From registration to progression or death, whichever occurs first, up to 2 years.|||months||95% Confidence Interval|Number
787089|NCT00840099|Primary|Bioequivalence Based on Cmax for Clavulanic Acid|Cmax - Maximum Observed Concentration|Blood samples collected over 14 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
786876|NCT00847808|Secondary|Change From Baseline in the Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QOL) - Psychological Well-being Subscale in Participants Who Remain Well-controlled.|PAGI-QOL is a 30-item self-reported instrument assessing health-related quality of life impact of upper gastrointestinal disorders. It includes 30 items across five subscales (daily activities, clothing, diet/food habits, relationship, psychological well-being and distress), scored on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (all the time). For reporting purposes, the scores are reversed and higher scores reflect improved quality of life and positive changes from baseline indicate improved quality of life.|Baseline and Week 6.|Values are from the Full Analysis Set.||units on a scale||Standard Deviation|Mean
786877|NCT00847808|Secondary|Change From Baseline in the Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QOL) - Relationship Subscale in Participants Who Remain Well-controlled.|PAGI-QOL is a 30-item self-reported instrument assessing health-related quality of life impact of upper gastrointestinal disorders. It includes 30 items across five subscales (daily activities, clothing, diet/food habits, relationship, psychological well-being and distress), scored on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (all the time). For reporting purposes, the scores are reversed and higher scores reflect improved quality of life and positive changes from baseline indicate improved quality of life.|Baseline and Week 6.|Values are from the Full Analysis Set.||units on a scale||Standard Deviation|Mean
786878|NCT00847808|Secondary|Change From Baseline in the Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QOL) - Diet and Food Habits Subscale in Participants Who Remain Well-controlled.|PAGI-QOL is a 30-item self-reported instrument assessing health-related quality of life impact of upper gastrointestinal disorders. It includes 30 items across five subscales (daily activities, clothing, diet/food habits, relationship, psychological well-being and distress), scored on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (all the time). For reporting purposes, the scores are reversed and higher scores reflect improved quality of life and positive changes from baseline indicate improved quality of life.|Baseline and Week 6.|Values are from the Full Analysis Set.||units on a scale||Standard Deviation|Mean
786879|NCT00847808|Secondary|Change From Baseline in the Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QOL) - Clothing Subscale in Participants Who Remain Well-controlled.|PAGI-QOL is a 30-item self-reported instrument assessing health-related quality of life impact of upper gastrointestinal disorders. It includes 30 items across five subscales (daily activities, clothing, diet/food habits, relationship, psychological well-being and distress), scored on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (all the time). For reporting purposes, the scores are reversed and higher scores reflect improved quality of life and positive changes from baseline indicate improved quality of life.|Baseline and Week 6.|Values are from the Full Analysis Set.||units on a scale||Standard Deviation|Mean
786880|NCT00847808|Secondary|Change From Baseline in the Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QOL) - Daily Activities Subscale in Participants Who Remain Well-controlled.|PAGI-QOL is a 30-item self-reported instrument assessing health-related quality of life impact of upper gastrointestinal disorders. It includes 30 items across five subscales (daily activities, clothing, diet/food habits, relationship, psychological well-being and distress), scored on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (all the time). For reporting purposes, the scores are reversed and higher scores reflect improved quality of life and positive changes from baseline indicate improved quality of life.|Baseline and Week 6.|Values are from the Full Analysis Set.||units on a scale||Standard Deviation|Mean
786881|NCT00847808|Primary|Proportion of Participants Who Remain Well Controlled After Switching From Their Current Twice-daily Proton Pump Inhibitor Therapy to Dexlansoprazole MR.|Well-controlled participants were defined to be participants who completed the study having at least 23 days of evaluable diary entries between Days 15 and 42, inclusive, and had ≤4 occurrences of heartburn during this period.|Week 3 through Week 6|Values are from the Full Analysis Set.||percent of participants|||Number
786882|NCT00847886|Secondary|Percentage of Change From Baseline in Absolute Total Lymphocyte Count at Day 15|Baseline was defined as pre-dose on Day 1.|Day 15|||Percent||Standard Deviation|Mean
786883|NCT00847886|Secondary|Half-life of LX3305 in Plasma in the Presence of MTX||Day 15|This outcome was not measured in the Methotrexate + LX3305 placebo subjects.||hours||Standard Deviation|Mean
786884|NCT00847886|Secondary|Time to Maximum Plasma Concentration of LX3305 in the Presence of MTX||Day 15|This outcome was not measured in the Methotrexate + LX3305 placebo subjects.||hours||Full Range|Median
786885|NCT00847886|Secondary|Maximum Plasma Concentration of LX3305 in the Presence of MTX||Day 15|This outcome was not measured in the Methotrexate + LX3305 placebo subjects.||ng/mL||Standard Deviation|Mean
786886|NCT00847886|Primary|Amount of 7-OH-MTX Excreted in the Urine||Day 15|||µg||Standard Deviation|Mean
786887|NCT00847886|Primary|Time to Reach Maximum Plasma Concentration of 7-OH-MTX||Day 15|||hours||Full Range|Median
786888|NCT00847886|Primary|7-Hydroxymethotrexate (7-OH-MTX) Maximum Plasma Concentration|7-OH-MTX is the primary metabolite of methotrexate.|Day 15|||ng/mL||Standard Deviation|Mean
786889|NCT00847886|Primary|Amount of Methotrexate Excreted in the Urine||Day 15|||µg||Standard Deviation|Mean
786890|NCT00847886|Primary|Half-life of Methotrexate in Plasma||Day 15|||hours||Standard Deviation|Mean
786891|NCT00847886|Primary|Time to Reach Maximum Plasma Concentration of Methotrexate||Day 15|||hours||Full Range|Median
786892|NCT00847886|Primary|Methotrexate Maximum Plasma Concentration||Day 15|||ng/mL||Standard Deviation|Mean
786896|NCT00848016|Secondary|Overall Survival|The overall survival time is defined as the time from registration to date of last follow-up or death due to any cause. Estimated using the method of Kaplan-Meier.|From registration to date of last follow-up or death due to any cause, assessed up to 2 years|||months||95% Confidence Interval|Median
786897|NCT00848016|Primary|The Proportion of Patients Who Achieve a Confirmed Objective Response to Treatment, Either Partial Response (PR) or Complete Response (CR) as Defined by Response Evaluation Criteria In Solid Tumors (RECIST) Criteria|"In order for a patient to be a confirmed objective responder, they must achieve a PR or CR on consecutive evaluations, at least 4 weeks apart. The proportion of patients who achieve a confirmed objective response to treatment will be estimated by the standard binomial estimator, i.e., the number of successes divided by the total number of evaluable patients.
Complete Response (CR): Disappearance of all target lesions and normalization of tumor biomarkers.
Partial Response (PR): At least a 30% decrease in the sum of the longest dimension (LD) of target lesions taking as reference the baseline sum LD."|Up to 2 years|||percentage of participants||95% Confidence Interval|Number
786898|NCT00848042|Secondary|Response in Targeted Tumors.||6 months|Data was not collected/analyzed|||||
786899|NCT00848042|Primary|Number of Participants With Any Adverse Device Effects Considered Attributable to AuroShell Particle Administration|Includes all participants that experienced an adverse device effect that were rated probable or definitely related to AuroShell particle infusion|up to 6 months|per protocol||participants|||Number
786900|NCT00848081|Secondary|Uroflowmetry (Qmax) Change From Baseline|Change from baseline to endpoint in Qmax. Qmax is defined as the peak urine flow rate (measured in milliliters per second [mL/second] using standard calibrated flowmeter).|Baseline, 12 Weeks|All randomized subjects with non-missing data.||milliliters per second||Standard Deviation|Mean
786901|NCT00848081|Secondary|Postvoid Residual Volume (PVR) Change From Baseline|Change from baseline to endpoint in PVR volume. PVR is obtained by measuring with ultrasound the remaining urine in the bladder after urination.|Baseline, 12 Weeks|All randomized subjects who had non-missing baseline and endpoint data.||milliliters||Standard Deviation|Mean
786902|NCT00848081|Secondary|International Prostate Symptom Score (IPSS) Change From Baseline|Change from baseline to endpoint in IPSS Score. The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.|Baseline, 12 Weeks|Primary Analysis Population-included all subjects who were randomized and took at least one dose of study medication and had non-missing baseline and endpoint data.||units on a scale||Standard Deviation|Mean
786903|NCT00848081|Secondary|Number of Participants With Positive Orthostatic Vital Signs Test; Shift From Any Pre-Randomization to Any Post-Randomization Visit|A positive orthostatic test is defined as at least one of the following 4 criteria being met at any pre-randomization or post-randomization visit: (1) reduction in systolic blood pressure of >= 20 mmHg from the supine to standing position;(2)reduction in diastolic blood pressure of >=10 mmHg from the supine to standing position;(3)increase in heart rate of >= 20 bpm from the supine to standing position; or (4)Unable to remain standing. A negative orthostatic test is defined as none of the above 4 criteria (1, 2, 3, or 4) being met at any pre-randomization or post-randomization visit.|Baseline through 12 Weeks|All randomized subjects in the analysis population with non-missing data.||Participants|||Number
786904|NCT00848081|Primary|Number of Men With Treatment-emergent Dizziness|The primary safety measure is the proportion (reported in numbers) of subjects experiencing treatment-emergent dizziness to include the Medical Dictionary for Regulatory Activities (MedDRA) preferred terms of dizziness, dizziness postural, and procedural dizziness. Treatment-emergent dizziness is defined as any of the predefined terms of dizziness that is first reported or worsens in severity after baseline.|Baseline through 12 Weeks|Primary Analysis Population-included all subjects who were randomized and took at least one dose of study medication.||Participants|||Number
786905|NCT00848107|Primary|Formation of New Ulcers|The number and percentage of subjects who developed new ulcers during the study were summarized.|18 months (or last study visit)|Efficacy was assessed by the change in net ulcer burden and in the total ulcer number from Baseline at each of the follow-up visits and the percentage of subjects with formation of new ulcers during the study. Assessments performed after discontinuation of study drug were excluded from the summaries.||participants|||Number
786906|NCT00848107|Primary|Total Ulcer Number- Mean Change From Time of Study Entry for Each Scheduled Visit Assessment|The total ulcer number includes all ulcers designated as “active”, “indeterminate”, or “new” for a given visit. The mean change in the total number of ulcers present from time of study entry was summarized for each scheduled visit assessment.|Baseline and Months 1, 3, 6, 9, 12, and 18|Efficacy was assessed by the change in net ulcer burden and in the total ulcer number from Baseline at each of the follow-up visits and the percentage of subjects with formation of new ulcers during the study. Assessments performed after discontinuation of study drug were excluded from the summaries.||number of ulcers||Standard Deviation|Mean
786907|NCT00848107|Secondary|Patient Function and Quality of Life Measure: Cochin Hand Function Scale (CHFS)-Mean Change From Study Entry in CHFS Score at Each Scheduled Assessment|The CHFS score is derived from 18 validated questions that assess functional disability and handicap due to hand involvement in rheumatoid arthritis. Each answer is scored on a scale with possible integer responses of 0(without difficulty) to 5 (impossible). The CHFS score is simply the sum of all 18 questions, divided by the number of questions actually answered, multiplied by 18. At least 10 of the 18 questions must have been answered in order for CHFS to be calculated. Therefore, CHFS score values can range from 0 (least limitation) to 90 (most limitation), with improvements in function or reduction of limitation indicated a decreased score value. The mean change from study entry in CHFS scores at each scheduled assessment are summarized.|Baseline and Months 1, 3, 6, and 12|Efficacy was assessed by the change in net ulcer burden and in the total ulcer number from Baseline at each of the follow-up visits and the percentage of subjects with formation of new ulcers during the study. Assessments performed after discontinuation of study drug were excluded from the summaries.||units on a scale||Standard Deviation|Mean
786908|NCT00848107|Primary|Net Ulcer Burden- Mean Change From Time of Study Entry for Each Scheduled Visit Assessment|Net ulcer burden at any given assessment was defined as the number of “new” or “active” ulcers at that assessment, plus the number of “indeterminate” ulcers at that assessment that had previously been classified as either “active” or “new” at any earlier assessment during the study. The mean change in net ulcer burden from time of study entry was summarized for each scheduled visit assessment.|Baseline and Months 1, 3, 6, 9, 12, and 18|Efficacy was assessed using data obtained at each visit, if available, from all subjects enrolled in this study. Assessments performed after discontinuation of study drug were excluded from the summaries.||ulcers||Standard Deviation|Mean
786909|NCT00848107|Secondary|Patient Function and QOL Measure: Scleroderma Health Assessments Questionnaire (SHAQ)- Mean Change From Study Entry in SHAQ Component Scores at Each Scheduled Assessment|The SHAQ consists of 20 health assessment questionnaire questions with integer responses of 0 (without any difficulty) to 3 (unable to do), and five scleroderma-specific visual analog scale (VAS) domains (Overall Disease Activity, Raynaud’s Phenomenon, Finger Ulcers, Breathing, and Intestinal Problems) with values ranging from 0.0 to 15.0 centimeters. The questions are divided into eight component domains: Dressing & Grooming, Arising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Each domain score is calculated by summing the domain responses and dividing by the number of questions in that domain. Each VAS domain score is calculated by dividing the value in centimeters by 5. SHAQ component and VAS domain score ranges from 0 (least limitation) to 3 (most limitation). The aggregate SHAQ score is calculated by dividing the sum of all domain scores by 13, with a score ranging from 0 (least limitation) to 3 (most limitation).|Baseline and Months 1, 3, 6, and 12|Efficacy was assessed by the change in net ulcer burden and in the total ulcer number from Baseline at each of the follow-up visits and the percentage of subjects with formation of new ulcers during the study. Assessments performed after discontinuation of study drug were excluded from the summaries.||units on a scale||Standard Deviation|Mean
786910|NCT00848120|Secondary|Time to Onset of ACR20/50/70 Response|Time to onset of ACR 20/50/70 response was calculated as the number of weeks from the administration of the first dose of study drug until the date of first achievement of ACR 20/50/70 per criteria.|Weeks 4, 8, 12, 16, 20, and 24|ITT Population||weeks||Inter-Quartile Range|Median
786911|NCT00848120|Secondary|Percentage of Participants With Low Disease Activity at Week 24 Assessed Using DAS28-ESR|DAS28-ESR calculated from the number of swollen joints and tender joints using the 28 joints count, the ESR (mm/hour) and Patient's Global Assessment of disease activity (participant rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 >2.6 and <3.2=low disease activity.|Week 24|ITT Population||percentage of participants|||Number
786912|NCT00848120|Secondary|Percentage of Participants With Disease Remission at Week 24 Assessed Using DAS28-ESR|DAS28-ESR calculated from the number of swollen joints and tender joints using the 28 joints count, the ESR (mm/hour) and Patient's Global Assessment of disease activity (participant rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 <2.6=remission.|Week 24|ITT Population||percentage of participants|||Number
786913|NCT00848120|Secondary|Disease Activity Score Based on 28 Joint Count - Erythrocyte Sedimentation Rate (DAS28-ESR) at Baseline and Week 24|DAS28-ESR calculated from the number of swollen joints and tender joints using the 28 joints count, the ESR (millimeters per hour [mm/hour]) and Patient's Global Assessment of disease activity (participant rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 less than or equal to (≤)3.2 equals (=) low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity.|Baseline and Week 24|ITT Population||units on a scale||Standard Deviation|Mean
786914|NCT00848120|Secondary|Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Baseline and Week 24|FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participants response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the health status.|Baseline and Week 24|ITT Population||units on a scale||Standard Deviation|Mean
786915|NCT00848120|Secondary|HAQ Disability Index (HAQ-DI) Score at Baseline and Week 24|HAQ-DI is a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Each domain has at least 2 component questions. There are 4 possible responses for each component 0=without any difficulty 1=with some difficulty 2=with much difficulty 3=unable to do. To calculate HAQ-DI the participant must have a domain score for at least 6 of 8 domains. The HAQ-DI is the sum of the scores, divided by the number of domains that have a score (in range 6-8) for a total possible score minimum/maximum 0 (best) to 3 (worst).|Baseline and Week 24|ITT Population||units on a scale||Standard Deviation|Mean
786916|NCT00848120|Secondary|Percentage of Participants Achieving ACR 70% Improvement (ACR70 Response) at Week 24|ACR70 response: ≥70% improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: 1) Physician's global assessment of disease activity, 2) participant assessment of disease activity, 3) Patient Assessment of Pain (VAS), 4) participant assessment of functional disability via a HAQ, and 5) ESR at each visit.|Week 24|ITT Population||percentage of participants|||Number
786917|NCT00848120|Secondary|Percentage of Participants Achieving ACR 50% Improvement (ACR50 Response) at Week 24|ACR50 response: ≥50% improvement in tender or swollen joint counts and 50% improvement in 3 of the following 5 criteria: 1) Physician's global assessment of disease activity, 2) participant assessment of disease activity, 3) Patient Assessment of Pain (VAS), 4) participant assessment of functional disability via a HAQ, and 5) ESR at each visit.|Week 24|ITT Population||percentage of participants|||Number
786918|NCT00848120|Primary|Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Percent (%) Improvement (ACR20 Response) at Week 24|ACR20 response: greater than or equal to (≥) 20% improvement in tender or swollen joint counts and 20% improvement in 3 of the following 5 criteria: 1) Physician's global assessment of disease activity, 2) participant assessment of disease activity, 3) Patient Assessment of Pain (visual analog scale [VAS]), 4) participant assessment of functional disability via a Health Assessment Questionnaire (HAQ), and 5) erythrocyte sedimentation rate (ESR) at each visit.|Week 24|ITT population||percentage of participants|||Number
786919|NCT00848172|Secondary|PK: AUC After OA|Area under the curve of PA plasma levels after administration|5 to 300 min post dose|||hr*ng/ml||Standard Deviation|Mean
786920|NCT00848172|Secondary|TMax Octanoic Acid|Time to plasma peak OA|between 5 and 300 min post dose|||min||Standard Deviation|Mean
786950|NCT00848250|Secondary|IL-8 (Interleukin-8)||Baseline (pre-surgery) to postoperative day 1|||pg/mL||Standard Error|Mean
786951|NCT00848250|Secondary|IL-6 (Interleukin-6)||Baseline (pre-surgery) to postoperative day 1|||pg/ml||Standard Error|Mean
786921|NCT00848172|Secondary|Normalized Tremor Power, 300 Min After Administration, Weighted Condition, Dominant Hand, OA vs Placebo|As described at the section for the primary outcome, normalized accelerometric tremor accelerometry was measured at other time-points to describe a time-course of effect. This stated secondary outcome compared normalized (baseline = 1) accelerometric at the last time-point 300 min post dose after OA vs Placebo. Ratios of tremor power at 300 min divided by tremor power at baseline used for outcome measure calculation.|300 min post dose|||ratio||Inter-Quartile Range|Median
786922|NCT00848172|Primary|Normalized Accelerometric Tremor Power, Dominant Hand, 80min After Administration, Weighted Condition|Postural tremor was measured using accelerometry with a motion sensor (accelerometer) placed at the dorsum of each hand, and tremor recorded simultaneously with surface-electromyography of wrist flexors and extensors for 2 minutes at each time-point. The recording was repeated with 1 lbs weight added to each wrist, which was described to record the central tremor component. The primary outcome measure was defined as tremor power of the central tremor component (after the addition of weight) 80 minutes after administration, measured at the dominant hand, normalized to baseline (baseline = 1), and comparing octanoic acid vs. placebo. Ratio of tremor power at 80 min divided by tremor power at baseline used for outcome measure calculation.|80 min after administration of the study drug on day 1 and 2 of Visit 2|2 patients were excluded from primary outcome measure analysis because of one subject was withdrawn prior to drug administration due to an SAE, and one subject did not exhibit a central tremor component (primary measure), on the day of administration.||ratio||Inter-Quartile Range|Median
786923|NCT00848185|Primary|VEGF Protein and mRNA Levels|VEGF concentration in follicular fluid and VEGF mRNA expression in granulosa cells from patients who received either GnRH agonist instead of hCG|1 year|||pg/ml||Standard Deviation|Mean
786924|NCT00848198|Secondary|Referent Values for Ocular Surface Disease Index|Ocular Surface Disease Index (OSDI) Questionnaire was used for symptoms assessment and the index is calculated based on the responses given by the subject. A cutoff of 15/100 score was used to differentiate between normal and dry eye subjects. A score of 0 confirms no dry eye symptoms are present, while a maximum of 100 indicates the maximum severity of symptoms experienced by subjects.|Single visit|||Score||Standard Deviation|Mean
786925|NCT00848198|Secondary|Referent Values for Meibomian Gland Grading|Meibomian gland dysfunction was assessed to grade the quality, expressibility, and volume of gland secretion, according to Bron/Foulks scoring system. A score of 0 indicates full integrity of these glands while the maximum of 27, is used for severe damage.|Single visit|||Grade||Standard Deviation|Mean
786926|NCT00848198|Secondary|Referent Values for Conjunctival Staining|Conjunctival staining is used to identify and evaluate dead or injured conjunctival cells. Conjunctival staining was performed 2.5 to 3.0 minutes after instillation of 10 μL of a 1% sodium lissamine green dye. Conjunctival staining followed the National Eye Institute/Industry Workshop scale. A cutoff threshold of grade >3/12 was used to differentiate normal from dry eye subjects. A score of 0 indicates no damage of conjunctival cells, while the maximum for the most severe damage is 12.|Single visit|||Grade||Standard Deviation|Mean
786927|NCT00848198|Secondary|Referent Values for Corneal Staining|Corneal Staining is used to identify and evaluate ocular surface and corneal damages. It was evaluated under cobalt blue illumination 2.5 to 3.0 minutes after fluorescein instillation. Staining amplitude followed the National Eye Institute/Industry Workshop scale. The cutoff threshold >4/15 was used to differentiate normals from dry eye subjects. A score of 0 indicates no damage of ocular surface/cornea, while the maximum for the most severe damage is 15.|Single visit|||Grade||Standard Deviation|Mean
786928|NCT00848198|Secondary|Referent Values for Tear Film Breakup Time||Single visit|||seconds||Standard Deviation|Mean
786929|NCT00848198|Secondary|Referent Values for Schirmer Test||Single visit|||mm||Standard Deviation|Mean
786930|NCT00848198|Secondary|Referent Values for Tear Osmolarity||Single visit|||mOsm/L||Standard Deviation|Mean
786931|NCT00848198|Primary|Diagnostic Test Data for Disease Using Ocular Surface Disease Index Threshold > 15/100|Ocular Surface Disease Index (OSDI) Questionnaire was used for symptoms assessment. A cutoff of 15/100 score was used to differentiate between normal and dry eye subjects. The clinical tools most commonly used in grading dry eye severity are symptomatology (e.g. questionnaires such as the Ocular Surface Disease Index (OSDI) or McMonnies Dry Eye Questionnaire), tear osmolarity, tear film breakup time (TBUT), fluoresceine or lissamine green staining of the cornea and conjunctiva, meibomiam secretion scoring, and the Schirmer test.To convert all the various clinical measurements into a common unit system, based on their breakpoints provided by the Dry Eye Workshop (DEWS), a composite score was created. Its scale being between 0 (representing the least evidence of disease) and 1 (representing the most evidence of disease).|Single visit|||participants|||Number
786932|NCT00848198|Primary|Diagnostic Test Data for Disease Using Meibomian Gland Grading Threshold > Grade 5/27|Meibomian dysfunction was assessed to grade the quality, expressibility, and volume of gland secretion, according to Bron/Foulks scoring system. A cutoff threshold of grade 5/27 was used to differentiate normal from dry eye subjects. The clinical tools most commonly used in grading dry eye severity are symptomatology (e.g. questionnaires such as the Ocular Surface Disease Index (OSDI) or McMonnies Dry Eye Questionnaire), tear osmolarity, tear film breakup time (TBUT), fluoresceine or lissamine green staining of the cornea and conjunctiva, meibomiam secretion scoring, and the Schirmer test.To convert all the various clinical measurements into a common unit system, based on their breakpoints provided by the Dry Eye Workshop (DEWS), a composite score was created. Its scale being between 0 (representing the least evidence of disease) and 1 (representing the most evidence of disease).|Single visit|||participants|||Number
786933|NCT00848198|Primary|Diagnostic Test Data for Disease Using Conjunctival Staining Threshold > Grade 3/12|Conjunctival staining was performed 2.5 to 3.0 minutes after instillation of 10 μL of a 1% sodium lissamine green dye. Conjunctival staining followed the National Eye Institute/Industry Workshop scale. A cutoff threshold of grade >3/12 was used to differentiate normal from dry eye subjects. The clinical tools most commonly used in grading dry eye severity are symptomatology (e.g. questionnaires such as the Ocular Surface Disease Index (OSDI) or McMonnies Dry Eye Questionnaire), tear osmolarity, tear film breakup time (TBUT), fluoresceine or lissamine green staining of the cornea and conjunctiva, meibomiam secretion scoring, and the Schirmer test. To convert all the various clinical measurements into a common unit system, based on their breakpoints provided by the Dry Eye Workshop (DEWS), a composite score was created. Its scale being between 0 (representing the least evidence of disease) and 1 (representing the most evidence of disease).|Single visit|||participants|||Number
786934|NCT00848198|Primary|Diagnostic Test Data for Disease Using Corneal Staining Threshold > Grade 4/15|Corneal Staining was evaluated under cobalt blue illumination 2.5 to 3.0 minutes after fluorescein instillation. Staining amplitude followed the National Eye Institute/Industry Workshop scale. The cutoff threshold >4/15 was used to differentiate normals from dry eye subjects. The clinical tools most commonly used in grading dry eye severity are symptomatology (e.g. questionnaires such as the Ocular Surface Disease Index (OSDI) or McMonnies Dry Eye Questionnaire), tear osmolarity, tear film breakup time (TBUT), fluoresceine or lissamine green staining of the cornea and conjunctiva, meibomiam secretion scoring, and the Schirmer test.To convert all the various clinical measurements into a common unit system, based on their breakpoints provided by the Dry Eye Workshop (DEWS), a composite score was created. Its scale being between 0 (representing the least evidence of disease) and 1 (representing the most evidence of disease).|Single visit|||participants|||Number
786935|NCT00848198|Primary|Diagnostic Test Data for Disease Using Tear Film Breakup Time Threshold < 5 Seconds|Tear film breakup time was measured by instilling 5μL of a 2% sodium fluoresceine solution and calculating the average of three consecutive breakup times, manually determined with a stopwatch. The cutoff of <5 seconds was used to differentiate normal from dry eye subjects. The clinical tools most commonly used in grading dry eye severity are symptomatology (e.g. questionnaires such as the Ocular Surface Disease Index (OSDI) or McMonnies Dry Eye Questionnaire), tear osmolarity, tear film breakup time (TBUT), fluoresceine or lissamine green staining of the cornea and conjunctiva, Meibomiann secretion scoring, and the Schirmer test. To convert all the various clinical measurements into a common unit system, based on their breakpoints provided by the Dry Eye Workshop (DEWS), a composite score was created. Its scale being between 0 (representing the least evidence of disease) and 1 (representing the most evidence of disease).|Single visit|||participants|||Number
786936|NCT00848198|Primary|Diagnostic Test Data for Disease Using Schirmer Test Threshold < 7 mm|"A 5-minute Schirmer test was performed with sterile strips without anesthetic (Tear Flo). The cutoff threshold of <7mm was used to differentiating normal from mild subjects.
The clinical tools most commonly used in grading dry eye severity are symptomatology (e.g. questionnaires such as the Ocular Surface Disease Index (OSDI) or McMonnies Dry Eye Questionnaire), tear osmolarity, tear film breakup time (TBUT), fluoresceine or lissamine green staining of the cornea and conjunctiva, meibomiam secretion scoring, and the Schirmer test. To convert all the various clinical measurements into a common unit system, based on their breakpoints provided by the Dry Eye Workshop (DEWS), a composite score was created. Its scale being between 0 (representing the least evidence of disease) and 1 (representing the most evidence of disease)."|Single visit|||participants|||Number
786937|NCT00848198|Primary|Diagnostic Test Data for Disease Using Tear Osmolarity Threshold > 308 mOsm/L|"Tear osmolarity was measured with a laboratory-on-a-chip, to simultaneously collect and analyze the electrical impedance of a 50 nL tear sample from the interior lateral meniscus (TearLab Osmolarity System). A cutoff threshold of more than 308 mOsm/L was used for differentiating normal from mild to moderate subjects.
The clinical tools most commonly used in grading dry eye severity are symptomatology (e.g. questionnaires such as the Ocular Surface Disease Index (OSDI) or McMonnies Dry Eye Questionnaire), tear osmolarity, tear film breakup time (TBUT), fluoresceine or lissamine green staining of the cornea and conjunctiva, meibomiam secretion scoring, and the Schirmer test.To convert all the various clinical measurements into a common unit system, based on their breakpoints provided by the Dry Eye Workshop (DEWS), a composite score was created. Its scale being between 0 (representing the least evidence of disease) and 1 (representing the most evidence of disease)."|Single visit|||participants|||Number
786938|NCT00848211|Primary|CD4+ T-cell Count|Change in CD4+ T-cell count from baseline|baseline and 20 weeks|||cells/mm3||Standard Error|Log Mean
786939|NCT00848211|Secondary|Determination of Anti-Tat Antibodies|Determination of change in anti-Tat antibody level|baseline and 16 weeks|||ng/mL||Full Range|Median
786940|NCT00848211|Primary|HIV Viral Load|Change in HIV viral load from baseline|baseline and 20 weeks|||HIV RNA copies/mL||Standard Error|Log Mean
786941|NCT00848237|Primary|Adverse Event Incidence|Adverse and Serious Adverse event with Definite device relationship|12 month|||participants|||Number
786942|NCT00848237|Primary|Patient Quality of Life Questionnaire Results: Change From Baseline to 12 Month|Patient who completed both baseline and follow-up Quality of Life: Scores (0-10) of quality of life at baseline and 12 month follow-up were measured and changes were calculated ( 12 months minus baseline) in: concerns about the condition of esophagus, negative impact on life and esophageal cancer worry. Scale range is 0-10, 0 is min and 10 is max. Higher value represent worse outcome (such as higher concern about the condition of esophagus, negative impact on life and higher esophageal cancer worry).|12 month|943 subjects completed both baseline and follow up quality of life life survey||units on a scale||Standard Deviation|Mean
786943|NCT00848237|Primary|Percentage of Patients With Sub-squamous Intestinal Metaplasia at 1 Year Follow up|Percentage of patients at 1 year follow-up with sub-squamous intestinal metaplasia, with or without dysplasia, that is covered completely by an intact layer of squamous epithelium with no communication with the surface|1 year|||percentage of patients with SSIM|||Number
786944|NCT00848237|Primary|Histological Clearance Rate for Dysplasia (CE-D)|percentage of patients with baseline dysplasia who have no histological evidence of dysplasia at 1 year follow-up|1 year|4118 provided biopsies at least 1 year post RFA and non dysplasia subjects from 4118 were removed for CE-D analysis||percentage of participants|||Number
786945|NCT00848237|Primary|Histological Clearance Rate for Intestinal Metaplasia (CE-IM)|Percentage of patients with no histological evidence of intestinal metaplasia at 1 year follow-up|1 year|4118 provided biopsies at least 1 year post RFA||percentage of participants|||Number
786946|NCT00848237|Primary|Endoscopic Clearance Rate for Barrett's Esophagus-Percentage of Patients With no Endoscopically Visible Barrett's Esophagus at 1 Year Follow-up|% of patients with 100 % resolution at 1 year follow-up. This endpoint is a visual and not reliable or accurate. A better measure of clearance of Barrett's esophagus is based on biopsies.|1 year|4011 subjects provided the answers||percentage of participants|||Number
786947|NCT00848250|Secondary|Postoperative Renal Function|Acute kidney injury occurring|Baseline (prior to surgery) to postoperative day 1|||Percentage of subject with AKI|||Number
786948|NCT00848250|Secondary|Postoperative Bleeding|Chest tube output at 4 and 24 hours after completion of surgery|24 hours|||mL/kg||Standard Error|Mean
786949|NCT00848250|Secondary|(MAP) Mean Arterial Blood Pressure||Baseline (prior to surgery) to postoperative day 1|||mmHg||Standard Error|Mean
786954|NCT00848354|Secondary|Change From Baseline in SF-36 Health Survey Social Functioning Domain Score at Week 8, Week 16, and Week 24|The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores – physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.|Week 8, Week 16, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||units on a scale||Standard Error|Least Squares Mean
786955|NCT00848354|Secondary|Change From Baseline in SF-36 Health Survey Role Limitations Due to Physical Health Domain Score at Week 8, Week 16, and Week 24|The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores – physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.|Week 8, Week 16, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||units on a scale||Standard Error|Least Squares Mean
786956|NCT00848354|Secondary|Change From Baseline in SF-36 Health Survey Physical Functioning Domain Score at Week 8, Week 16, and Week 24|The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores – physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.|Week 8, Week 16, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||units on a scale||Standard Error|Least Squares Mean
786957|NCT00848354|Secondary|Change From Baseline in SF-36 Health Survey Mental Health Domain Score at Week 8, Week 16, and Week 24|The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores – physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.|Week 8, Week 16, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||units on a scale||Standard Error|Least Squares Mean
786958|NCT00848354|Secondary|Change From Baseline in SF-36 Health Survey General Health Perceptions Domain Score at Week 8, Week 16, and Week 24|The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores – physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.|Week 8, Week 16, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||units on a scale||Standard Error|Least Squares Mean
786959|NCT00848354|Secondary|Change From Baseline in SF-36 Health Survey Role Limitations Due to Emotional Problems Domain Score at Week 8, Week 16, and Week 24|The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores – physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.|Week 8, Week 16, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||units on a scale||Standard Error|Least Squares Mean
786960|NCT00848354|Secondary|Change From Baseline in SF-36 Health Survey Bodily Pain Domain Score at Week 8, Week 16, and Week 24|The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores – physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.|Week 8, Week 16, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||units on a scale||Standard Error|Least Squares Mean
787132|NCT00840866|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
786961|NCT00848354|Secondary|Change From Baseline in SF-36 Health Survey Physical Component Score at Week 50, Week 76, Week 102, and Week 128|The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores – physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.|Week 50, Week 76, Week 102, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).||units on a scale||Standard Deviation|Mean
786962|NCT00848354|Secondary|Change From Baseline in SF-36 Health Survey Physical Component Score at Week 8, Week 16, and Week 24|The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores – physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.|Week 8, Week 16, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||units on a scale||Standard Error|Least Squares Mean
786963|NCT00848354|Secondary|Change From Baseline in SF-36 Health Survey Mental Component Score at Week 50, Week 76, Week 102, and Week 128|The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores – physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.|Week 50, Week 76, Week 102, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).||units on a scale||Standard Deviation|Mean
786964|NCT00848354|Secondary|Change From Baseline in SF-36 Health Survey Mental Component Score at Week 8, Week 16, and Week 24|The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores – physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.|Week 8, Week 16, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||units on a scale||Standard Error|Least Squares Mean
786965|NCT00848354|Secondary|Change From Baseline in SF-36 Health Survey Vitality Domain Score at Week 50, Week 76, Week 102, and Week 128|The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores – physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.|Week 50, Week 76, Week 102, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).||units on a scale||Standard Deviation|Mean
786966|NCT00848354|Secondary|Change From Baseline in SF-36 Health Survey Vitality Domain Score at Week 8, Week 16, and Week 24|The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores – physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.|Week 8, Week 16, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||units on a scale||Standard Error|Least Squares Mean
786967|NCT00848354|Secondary|Change From Baseline in CRP at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. CRP was analysed at a central laboratory.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||mg / dL||Standard Error|Least Squares Mean
786968|NCT00848354|Secondary|Change From Baseline in Westergren ESR at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hour. A higher rate is consistent with inflammation. ESR was performed at the investigative site using an ESR kit supplied by the centralized laboratory.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).||mm/hour||Standard Deviation|Mean
786969|NCT00848354|Secondary|Change From Baseline in Westergren ESR at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hour. A higher rate is consistent with inflammation. ESR was performed at the investigative site using an ESR kit supplied by the centralized laboratory.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||mm/hour||Standard Error|Least Squares Mean
786970|NCT00848354|Secondary|Change From Baseline in Erosion Score Using vdH mTSS at Week 24|mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Each x-ray visit included 4 films, each of which were read by 2 readers. The mTSS was calculated by the images scored for erosions and JSN. An increase in mTSS from Baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Week 24|xITT population included all participants who took at least 1 dose of study drug and had evaluable radiographic data at Baseline and Week 24.||units on a scale||Standard Error|Least Squares Mean
786971|NCT00848354|Secondary|Change From Baseline in Joint Space Narrowing Score Using vdH mTSS at Week 24|mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Each x-ray visit included 4 films, each of which were read by 2 readers. The mTSS was calculated by the images scored for erosions and JSN. An increase in mTSS from Baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Week 24|xITT population included all participants who took at least 1 dose of study drug and had evaluable radiographic data at Baseline and Week 24.||units on a scale||Standard Error|Least Squares Mean
786972|NCT00848354|Secondary|Change From Baseline in Fatigue VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|The participants had to indicate on a 100 mm-VAS (0 mm: no fatigue, 100 mm: a great deal of fatigue) how much of a problem had fatigue or tiredness been for them in the preceding week.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).||mm||Standard Deviation|Mean
786973|NCT00848354|Secondary|Change From Baseline in Fatigue VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|The participants had to indicate on a 100 mm-VAS (0 mm: no fatigue, 100 mm: a great deal of fatigue) how much of a problem had fatigue or tiredness been for them in the preceding week.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||mm||Standard Error|Least Squares Mean
786974|NCT00848354|Secondary|Change From Baseline in Pain VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|The participants had to indicate on a 100 mm-VAS (0 mm: no pain, 100 mm: pain as bad as it could be) the amount of pain they experienced over the preceding 2-3 days.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).||mm||Standard Deviation|Mean
786975|NCT00848354|Secondary|Change From Baseline in Pain VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|The participants had to indicate on a 100 mm-VAS (0 mm: no pain, 100 mm: pain as bad as it could be) the amount of pain they experienced over the preceding 2-3 days.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||mm||Standard Error|Least Squares Mean
786976|NCT00848354|Secondary|Change From Baseline in General Health VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|The participants had to indicate on a 100 mm-VAS (0 mm: very well, 100 mm: extremely bad) in general how they rated their health over the preceding 2-3 weeks.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).||mm||Standard Deviation|Mean
786977|NCT00848354|Secondary|Change From Baseline in General Health VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|The participants had to indicate on a 100 mm-VAS (0 mm: very well, 100 mm: extremely bad) in general how they rated their health over the preceding 2-3 weeks.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||mm||Standard Error|Least Squares Mean
786978|NCT00848354|Secondary|Change From Baseline in Duration of Morning Stiffness at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|The duration of morning stiffness was determined over the preceding 2 days using a 2-question worksheet.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).||min||Standard Deviation|Mean
786979|NCT00848354|Secondary|Change From Baseline in Duration of Morning Stiffness at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|The duration of morning stiffness was determined over the preceding 2 days using a 2-question worksheet.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||min||Standard Error|Least Squares Mean
786980|NCT00848354|Secondary|Change From Baseline in Subject Global Assessment Score at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|The participant assessed overall arthritis activity on a scale from 0 (no disease activity) to 10 (extreme disease activity).|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).||units on a scale||Standard Deviation|Mean
786981|NCT00848354|Secondary|Change From Baseline in Subject Global Assessment Score at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24|The participant assessed overall arthritis activity on a scale from 0 (no disease activity) to 10 (extreme disease activity).|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||units on a scale||Standard Error|Least Squares Mean
786982|NCT00848354|Secondary|Change From Baseline in Physician Global Assessment Score at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|The participant`s global disease activity was estimated over the preceding 2-3 days on a scale from 0 (no disease activity) to 10 (extreme disease activity) by the physician.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).||units on a scale||Standard Deviation|Mean
786983|NCT00848354|Secondary|Change From Baseline in Physician Global Assessment Score at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|The participant`s global disease activity was estimated over the preceding 2-3 days on a scale from 0 (no disease activity) to 10 (extreme disease activity) by the physician.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||units on a scale||Standard Error|Least Squares Mean
786984|NCT00848354|Secondary|Change From Baseline in Swollen Joint Counts at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|Swollen joint count is a physical assessment of the ACR-specified 66 joint set for swelling. Each joint is rated as either swollen or not swollen with the total number of swollen joints reported as the score. Score range is from 0-66 with lower scores indicating the better outcome.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).||units on a scale||Standard Deviation|Mean
786985|NCT00848354|Secondary|Change From Baseline in Swollen Joint Counts at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|Swollen joint count is a physical assessment of the ACR-specified 66 joint set for swelling. Each joint is rated as either swollen or not swollen with the total number of swollen joints reported as the score. Score range is from 0-66 with lower scores indicating the better outcome.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||units on a scale||Standard Error|Least Squares Mean
786986|NCT00848354|Secondary|Change From Baseline in Painful Joint Counts at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|Painful joint count is a physical assessment of the ACR-specified 68 joint set for tenderness/pain. Each joint is rated as either painful or not painful with the total number of painful joints reported as the score. Score range is from 0-68 with lower scores indicating the better outcome.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).||units on a scale||Standard Deviation|Mean
786987|NCT00848354|Secondary|Change From Baseline in Painful Joint Counts at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|Painful joint count is a physical assessment of the ACR-specified 68 joint set for tenderness/pain. Each joint is rated as either painful or not painful with the total number of painful joints reported as the score. Score range is from 0-68 with lower scores indicating the better outcome.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||units on a scale||Standard Error|Least Squares Mean
786988|NCT00848354|Secondary|Percentage of Participants Achieving DAS28 Improvement of ≥1.2 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant`s general health using a 100 mm-VAS. DAS28<3.2: low disease activity, DAS28<2.6: remission.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).||percentage of participants|||Number
786989|NCT00848354|Secondary|Percentage of Participants Achieving DAS28 Improvement of ≥1.2 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant`s general health using a 100 mm-VAS. DAS28<3.2: low disease activity, DAS28<2.6: remission.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||percentage of participants|||Number
787090|NCT00840099|Primary|Bioequivalence Based on AUC0-t for Amoxicillin|AUC0-t - Area under the concentration-time curve from time zero to the time of last non-zero concentration|Blood samples collected over 14 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
786990|NCT00848354|Secondary|Percentage of Participants Achieving DAS28 Improvement of ≥0.6 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant`s general health using a 100 mm-VAS. DAS28<3.2: low disease activity, DAS28<2.6: remission.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).||percentage of participants|||Number
786991|NCT00848354|Secondary|Percentage of Participants Achieving DAS28 Improvement of ≥0.6 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant`s general health using a 100 mm-VAS. DAS28<3.2: low disease activity, DAS28<2.6: remission.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||percentage of participants|||Number
786992|NCT00848354|Secondary|Percentage of Participants Achieving DAS28<3.2 (Low Disease Activity) Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant`s general health using a 100 mm-VAS. DAS28<3.2: low disease activity, DAS28<2.6: remission.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).||percentage of participants|||Number
786993|NCT00848354|Secondary|Percentage of Participants Achieving DAS28<3.2 (Low Disease Activity) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant`s general health using a 100 mm-VAS. DAS28<3.2: low disease activity, DAS28<2.6: remission.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||percentage of participants|||Number
786994|NCT00848354|Secondary|Percentage of Participants Achieving DAS28<2.6 (Remission) Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant`s general health using a 100 mm-VAS. DAS28<3.2: low disease activity, DAS28<2.6: remission.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).||percentage of participants|||Number
786995|NCT00848354|Secondary|Percentage of Participants Achieving DAS28<2.6 (Remission) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant`s general health using a 100 mm-VAS. DAS28<3.2: low disease activity, DAS28<2.6: remission.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||percentage of participants|||Number
786996|NCT00848354|Secondary|Percentage of Participants Achieving Good DAS28-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Good DAS28-based EULAR response was defined as: DAS28-value ≤3.2 and DAS28-improvement from Baseline >1.2.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).||percentage of participants|||Number
786997|NCT00848354|Secondary|Percentage of Participants Achieving Good DAS28-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Good DAS28-based EULAR response was defined as: DAS28-value ≤3.2 and DAS28-improvement from Baseline >1.2.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||percentage of participants|||Number
786998|NCT00848354|Secondary|Percentage of Participants Achieving Moderate/Good DAS28-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|"DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Moderate or good DAS28-based EULAR response was defined as:
DAS28-value ≤5.1 and DAS28-improvement from Baseline >0.6
DAS28-value >5.1 and DAS28-improvement from Baseline >1.2"|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).||percentage of participants|||Number
787008|NCT00848354|Secondary|Percentage of Participants Achieving DAS<1.6 (Remission) Response at Week 24|DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant`s general health using a 100 mm-VAS. DAS<2.4: low disease activity, DAS<1.6: remission.|Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||percentage of participants|||Number
786999|NCT00848354|Secondary|Percentage of Participants Achieving Moderate/Good DAS28-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|"DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Moderate or good DAS28-based EULAR response was defined as:
DAS28-value ≤5.1 and DAS28-improvement from Baseline >0.6
DAS28-value >5.1 and DAS28-improvement from Baseline >1.2"|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||percentage of participants|||Number
787000|NCT00848354|Secondary|Percentage of Participants Achieving Good DAS-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|DAS-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Good DAS-based EULAR response was defined as: DAS-value ≤2.4 and DAS-improvement from Baseline >1.2.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).||percentage of participants|||Number
787001|NCT00848354|Secondary|Percentage of Participants Achieving Good DAS-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|DAS-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Good DAS-based EULAR response was defined as: DAS-value ≤2.4 and DAS-improvement from Baseline >1.2.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||percentage of participants|||Number
787002|NCT00848354|Secondary|Percentage of Participants Achieving Moderate/Good Disease DAS-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|"DAS-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Moderate or good DAS-based EULAR response was defined as:
DAS-value ≤3.7 and DAS-improvement from Baseline >0.6
DAS-value >3.7 and DAS-improvement from Baseline >1.2"|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).||percentage of participants|||Number
787003|NCT00848354|Secondary|Percentage of Participants Achieving Moderate/Good DAS-Based European League Against Rheumatism (EULAR) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|"DAS-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Moderate or good DAS-based EULAR response was defined as:
DAS-value ≤3.7 and DAS-improvement from Baseline >0.6
DAS-value >3.7 and DAS-improvement from Baseline >1.2"|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||percentage of participants|||Number
787004|NCT00848354|Secondary|Percentage of Participants Achieving DAS Improvement of ≥1.2 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant`s general health using a 100 mm-VAS. DAS<2.4: low disease activity, DAS<1.6: remission.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).||percentage of participants|||Number
787005|NCT00848354|Secondary|Percentage of Participants Achieving DAS Improvement of ≥1.2 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant`s general health using a 100 mm-VAS. DAS<2.4: low disease activity, DAS<1.6: remission.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||percentage of participants|||Number
787006|NCT00848354|Secondary|Percentage of Participants Achieving DAS Improvement of ≥0.6 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant`s general health using a 100 mm-VAS. DAS<2.4: low disease activity, DAS<1.6: remission.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).||percentage of participants|||Number
787007|NCT00848354|Secondary|Percentage of Participants Achieving DAS Improvement of ≥0.6 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant`s general health using a 100 mm-VAS. DAS<2.4: low disease activity, DAS<1.6: remission.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||percentage of participants|||Number
787026|NCT00848367|Primary|Frequency of Binge Eating in the Past 28 Days||Pre and Post treatment, 6 months and 1 year|||days||Standard Deviation|Mean
787009|NCT00848354|Secondary|Percentage of Participants Achieving DAS<2.4 (Low Disease Activity) Response at Week 24|DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant`s general health using a 100 mm-VAS. DAS<2.4: low disease activity, DAS<1.6: remission.|Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||percentage of participants|||Number
787010|NCT00848354|Secondary|Change From Baseline in DAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant`s general health using a 100 mm-VAS. DAS≤2.4 indicates low disease activity and DAS<1.6 remission.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).||units on a scale||Standard Deviation|Mean
787011|NCT00848354|Secondary|Change From Baseline in Disease Activity Score (DAS) at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|DAS calculated from number of painful joints using the ritchie articular index (RAI), number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant`s general health using a 100 mm-VAS. DAS≤2.4 indicates low disease activity and DAS<1.6 remission.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||units on a scale||Standard Error|Least Squares Mean
787012|NCT00848354|Secondary|Percentage of Participants Achieving ACR70 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|ACR70 response: greater than or equal to 70 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 70 percent improvement from Baseline in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; participant's self-assessed disability (disability index of HAQ); and ESR.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).||percentage of participants|||Number
787013|NCT00848354|Secondary|Percentage of Participants Achieving ACR70 Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|ACR70 response: greater than or equal to 50 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 70 percent improvement from Baseline in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; participant's self-assessed disability (disability index of HAQ); and CRP.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||percentage of participants|||Number
787014|NCT00848354|Secondary|Percentage of Participants Achieving ACR20 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|ACR20 response: greater than or equal to 20 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 20 percent improvement from Baseline in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; participant's self-assessed disability (disability index of HAQ); and ESR.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).||percentage of participants|||Number
787015|NCT00848354|Secondary|Percentage of Participants Achieving ACR20 Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|ACR20 response: greater than or equal to 20 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 20 percent improvement from Baseline in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; participant's self-assessed disability (disability index of HAQ); and CRP.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||percentage of participants|||Number
787016|NCT00848354|Secondary|Percentage of Participants Achieving ACR50 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|ACR50 response: greater than or equal to 50 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 50 percent improvement from Baseline in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; participant's self-assessed disability (disability index of HAQ); and ESR.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).||percentage of participants|||Number
787027|NCT00839527|Secondary|Change From Baseline in Body Weight at Week 104 and Week 156|The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. This analysis used observed body weight values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|Baseline, Week 104, and Week 156|ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed (represented by n=X, X, X in the category titles).||Kilograms||Standard Deviation|Mean
787017|NCT00848354|Secondary|Percentage of Participants Achieving ACR50 Response at Week 2, Week 4, Week 8, Week 12, Week 16, and Week 20|ACR50 response: greater than or equal to 50 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 50 percent improvement from Baseline in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; participant's self-assessed disability (disability index of HAQ); and CRP.|Week 2, Week 4, Week 8, Week 12, Week 16, and Week 20|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||percentage of participants|||Number
787018|NCT00848354|Secondary|Summary of Changes in Therapy at the Beginning of Phase 2|The investigators were allowed to alter each participant`s therapy at the beginning of Phase 2. Continuations, discontinuations and additions made to Phase 1 treatment regimen were summarized.|Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used. One participant was randomized to etanercept but received SSZ in Phase 1.||participants|||Number
787019|NCT00848354|Secondary|Change From Baseline in DAS28 at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|DAS28 calculated from the number of swollen joints and painful joints using the 28 joints count, the ESR (mm/hour) and the participant`s general health using a 100 mm-VAS. DAS28<3.2 indicates low disease activity and DAS28<2.6 remission.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).||units on a scale||Standard Deviation|Mean
787020|NCT00848354|Secondary|Change From Baseline in Disease Activity Score Based on a 28-joint Count (DAS28) at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|DAS28 calculated from the number of swollen joints and painful joints using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour; mm/hour) and the participant`s general health using a 100 mm-visual analog scale (VAS). DAS28<3.2 indicates low disease activity and DAS28<2.6 remission.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||units on a scale||Standard Error|Least Squares Mean
787021|NCT00848354|Secondary|Change From Baseline in Van Der Heijde Modified Total Sharp Score (vdH mTSS), Annualized, at Week 24|mTSS: sum of erosion and joint space narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Each x-ray visit included 4 films, each of which were read by 2 readers. The mTSS was calculated by the images scored for erosions and JSN. An increase in mTSS from Baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Baseline and Week 24|Radiographic intent-to-treat (xITT) population included all participants who took at least 1 dose of study drug and had evaluable radiographic data at Baseline and Week 24.||units on a scale||Standard Error|Least Squares Mean
787022|NCT00848354|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Score at Week 24|The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores – physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.|Baseline and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||Units on a scale||Standard Error|Least Squares Mean
787023|NCT00848354|Secondary|Change From Baseline in HAQ Score at Week 24|HAQ: self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ score range: 0-3: without any difficulty: 0, with some difficulty: 1, with much difficulty: 2, unable to do: 3. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25: normal functioning; 0.25-0.5: mild functional limitation; 0.5-1: moderate functional limitation; more than 1: significant functional limitation.|Baseline and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||Units on a scale||Standard Error|Least Squares Mean
787024|NCT00848354|Primary|Percentage of Participants Achieving American College of Rheumatology 50 (ACR50) Response at Week 24|ACR50 response: greater than or equal to 50 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 50 percent improvement from Baseline in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; participant's self-assessed disability (disability index of the Health Assessment Questionnaire; HAQ); and C-Reactive Protein (CRP).|Week 24|Modified intent-to-treat (mITT) population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. Last Observation carried forward (LOCF) method was used.||Percentage of participants|||Number
787025|NCT00848367|Secondary|Depression Symptoms|Early response to treatment is indicated by a reduction in depression symptoms measured by The Beck Depression Inventory II (BDI-II; Beck, Steer, & Brown, 1996). The BDI-II is scored by summing the ratings for the 21 items. Each item is rated on a 4-point scale ranging from 0 to 3. The range for this scale is 0-63. Higher scores represent more depressive symptoms. We included cases that were missing up to 8 missing items and calculated scores for participants with missing items by taking the weighted mean and multiplying by 21.|Pre and Post treatment, 6 months and 1 year|||units on a scale||Standard Deviation|Mean
787028|NCT00839527|Secondary|Change From Baseline in Body Weight at Week 52|The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The LOCF method was used to impute missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values. Based on ANCOVA: change = treatment + Baseline weight + Baseline HbA1c category + prior myocardial infarction history + age category + region.|Baseline and Week 52|ITT Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 52.||Kilograms||Standard Error|Least Squares Mean
787029|NCT00839527|Secondary|Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156|The number of participants who acheieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <7%, and <7.5% at Week 156) was assessed.|Week 156|ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed. This analysis used observed HbA1c values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.||Participants|||Number
787030|NCT00839527|Secondary|Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 52|The number of participants who acheieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <7%, and <7.5% at Week 52) was assessed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 52.|Week 52|ITT Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed.||Participants|||Number
787031|NCT00839527|Secondary|Time to Hyperglycemia Rescue|Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue. The conditions for hyperglycemia rescue were as follows: FPG >=280 milligrams/deciliter (mg/dL) between >=Week 2 and <Week 4; FPG >=250 mg/dL between >=Week 4 and <Week 12; HbA1c >=8.5% and a <=0.5% reduction from Baseline between >=Week 12 and <Week 24; HbA1c >=8.5% between >=Week 24 and <Week 48; HbA1c >=8.0% between >= Week 48 and <Week 156. Participants could have been rescued at any time on or after Week 2. Time to hyperglycemia rescue is defined as the time between the date of the first dose of study medication and the date of hyperglycemia rescue plus 1 day, or the time between the date of the first dose of study medication and the date of the last visit during the active treatment period plus 1 day for participants not requiring rescue. This time was divided by 7 to express the result in weeks.|From the start of study medication until the end of the treatment (up to Week 156)|ITT Population||Weeks||95% Confidence Interval|Median
787032|NCT00839527|Secondary|Change From Baseline in FPG at Week 104 and Week 156|The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed FPG values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|Baseline, Week 104, and Week 156|ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed (represented by n=X, X, X in the category titles).||Millimoles per liter (mmol/L)||Standard Deviation|Mean
787033|NCT00839527|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52|The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. The LOCF method was used to impute missing post-Baseline FPG values. FPG values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on ANCOVA: change = treatment + Baseline FPG + Baseline HbA1c category + prior myocardial infarction history + age category + region.|Baseline and Week 52|Intent-to-Treat (ITT) Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 52.||Millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
787034|NCT00839527|Secondary|Change From Baseline in HbA1c at Week 104 and Week 156|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed HbA1c values, excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|Baseline, Week 104, and Week 156|ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed (represented by n=X, X, X in the category titles).||Percentage of HbA1c in the blood||Standard Deviation|Mean
787035|NCT00839527|Primary|Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The BL HbA1c value is defined as the last non-missing value before the start of treatment. Change from BL was calculated as the value at Week 52 minus the value at BL. Based on analysis of covariance (ANCOVA): change = treatment + BL HbA1c + prior myocardial infarction history + age category + region. The last observation carried forward (LOCF) method was used to impute missing post-BL HbA1c values; the last non-missing post-BL on-treatment measurement was used to impute the missing measurement. HbA1c values obtained after hyperglycemic rescue were treated as missing and were replaced with pre-rescue values. Nine par. with post-BL values obtained >14 days after the last dose or after hyperglycemic rescue were included in the analysis population but were not analyzed for this endpoint.|Baseline and Week 52|Intent-to-Treat (ITT) Population with LOCF: all randomized par. who received >=1 dose of study medication and who had a BL assessment and >=1 post-BL assessment of HbA1c. Only par. with a value at BL and at the specified visit were analyzed. Values were carried forward for par. who were rescued or discontinued from active treatment before Week 52.||Percentage of HbA1c in the blood||Standard Error|Least Squares Mean
787066|NCT00839930|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration|Bioequivalence based on AUC0-t|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
787133|NCT00840866|Primary|Cmax (Maximum Observed Concentration)|Bioequivalence based on Cmax.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
787036|NCT00839540|Primary|Serum Cidal Activity as Tested Against Various Candida Isolates and Reported as Ex-vivo Effect (Log Inhibition of Growth)|"Serum cidal activity of serum collected at different timepoints from the patients will be tested against various Candida isolates and the ex-vivo effect reported as log inhibition (logrithmic measurement of the decrease in microbiological growth).
These Candida isolates had a range of minimum inhibitory concentrations (MIC) to Caspofungin (C) and Micafungin (M)."|Pre-treatment, 1.5 hour (h), 12 h and 24 h after receiving the drug|Each subject received drug and had serum samples drawn at pre-treatment, 1.5h, 12h, and 24h after dosing.||Log inhibition|Participants||Number
787037|NCT00839800|Secondary|Asthma Control Questionnaire (ACQ)|The ACQ developed by Juniper and colleagues (Juniper et al 1999) was used without the FEV1 and Beta 2-agonist questions. The Asthma Control Questionnaire has 5 questions that are assessed on a 7-point scale from 0 to 6 where 0 represents good control and 6 represents poor control. The overall score is the mean of the five responses. At least 4 out of the 5 questions must have been answered to provide a value. The mean of the overall score for Weeks 4 to 52 was presented here.|4, 12, 24, 36 and 52 weeks after randomization|The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.||units on a scale||Standard Deviation|Mean
787038|NCT00839800|Secondary|Percentage of Asthma-control Days (no Asthma Symptoms, no Awakenings, and no As-needed Use)|An asthma-control day was defined as a a night and day with no asthma symptoms, no awakenings due to asthma symptoms, and no as-needed medication use. The mean value from the treatment period was presented here.|52-week treatment period|The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.||percentage of asthma-control days||Standard Deviation|Mean
787039|NCT00839800|Secondary|Percentage of As-needed-free Days|An as-needed-free day is defined as a night and day with no use of as-needed medication. The mean value from the treatment period was presented here.|52-week treatment period|The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.||percentage of as-needed-free days||Standard Deviation|Mean
787040|NCT00839800|Secondary|Symptom-free Days (no Symptoms and no Awakenings)|A symptom-free day was defined as a day without daytime or night-time symptoms and without night-time awakenings due to asthma symptoms. The mean value was presented here.|52-week treatment period|The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.||symptom-free days||Standard Deviation|Mean
787041|NCT00839800|Secondary|The Percentage of Participants Who Had Experienced First Mild Asthma Exacerbations|Mild asthma exacerbation was defined as morning PEF ≥20% below baseline, daily as-needed medication use ≥2 inhalations above baseline, or a night with awakening due to asthma symptoms. The percentage of participants who had experienced mild asthma exacerbation(s) at the end of the study was presented here.|up to 52 weeks|The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.||percentage of participants|||Number
787042|NCT00839800|Secondary|Nights With Awakening(s) Due to Asthma Symptoms|The mean value from the treatment period was presented here.|52-week treatment period|The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.||Nights With Awakening(s)||Standard Deviation|Mean
787043|NCT00839800|Secondary|Asthma Symptom Score|The mean value from the treatment period for Total Asthma Symptom Score (total score: 0 is best - no asthma symptoms; 6 is worst).|52-week treatment period|The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.||units on a scale||Standard Deviation|Mean
787044|NCT00839800|Secondary|Use of As-needed Medication|The mean value of total daily number of inhalations from the treatment period for use of as-needed medication (daytime, night-time).|52-week treatment period|The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.||inhalations/day||Standard Deviation|Mean
787045|NCT00839800|Secondary|Forced Expiratory Volume in One Second (FEV1)|The mean value for Weeks 4, 12, 24, 36 and 52 was analysed.|4, 12, 24, 36 and 52 weeks after randomization|The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.||Liter (L)||Standard Deviation|Geometric Mean
787046|NCT00839800|Secondary|Evening PEF|The mean value from a 52-week treatment period.|2-week run-in period (14 - 18 days before randomization - week 0) and a 52-week treatment period|The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.||L/min||Standard Deviation|Mean
787047|NCT00839800|Secondary|Morning Peak Expiratory Flow (PEF)|The mean value from a 52-week treatment period.|52-week treatment period|The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.||Liter/minute (L/min)||Standard Deviation|Mean
787048|NCT00839800|Secondary|Number of Asthma Exacerbations|Asthma exacerbation was defined as deterioration in asthma leading to oral GCS treatment, hospitalization, or ER treatment. Number of asthma exacerbations during 52 weeks treatment was presented here.|up to 52 weeks|The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.||Asthma exacerbations|||Number
787049|NCT00839800|Primary|The Percentage of Participants Who Had Experienced Asthma Exacerbation(s) at the End of the Study|Asthma exacerbation was defined as deterioration in asthma leading to oral glucocorticosteroid [GCS] treatment, hospitalization, or emergency room [ER] treatment.|week 52|The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.||percentage of participants|||Number
787050|NCT00839917|Other Pre-specified|Percentage of Participants With Fever (≥101.0°F [38.3°C] Axillary or ≥103.0°F [39.4°C] Rectal)||Through 6 weeks postvaccination|The safety population included all participants who received study vaccination||percentage of participants|||Number
787051|NCT00839917|Other Pre-specified|Percentage of Participants With Injection-site Adverse Experiences|An adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience. An injection-site adverse experience is an adverse experience that occurs at the injection site only.|Through 5 days postvaccination|The safety population included all participants who received study vaccination||percentage of participants|||Number
787067|NCT00839930|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
787052|NCT00839917|Other Pre-specified|Percentage of Participants With Injection-site Adverse Experiences|An adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience. An injection-site adverse experience is an adverse experience that occurs at the injection site only.|Through 6 weeks postvaccination|The safety population included all participants who received study vaccination||percentage of participants|||Number
787053|NCT00839917|Other Pre-specified|Percentage of Participants With Any Systemic Adverse Experience|"An adverse experience is defined as any unfavorable and unintended change in the
structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience. A systemic adverse experience is any adverse experience other than injection-site adverse experiences."|Through 6 weeks postvaccination|The safety population included all participants who received study vaccination||percentage of participants|||Number
787054|NCT00839917|Other Pre-specified|Percentage of Participants With Zoster-like Rash||Through 6 weeks postvaccination|The safety population included all participants who received study vaccination||percentage of participants|||Number
787055|NCT00839917|Other Pre-specified|Percentage of Participants With Rubella-like Rash||Through 6 weeks postvaccination|The safety population included all participants who received study vaccination||percentage of participants|||Number
787056|NCT00839917|Other Pre-specified|Percentage of Participants With Varicella-like Rash||Through 6 weeks postvaccination|The safety population included all participants who received study vaccination||percentage of participants|||Number
787057|NCT00839917|Other Pre-specified|Percentage of Participants With Measles-like Rash||Through 6 weeks postvaccination|The safety population included all participants who received study vaccination||percentage of participants|||Number
787058|NCT00839917|Secondary|Geometric Mean Titer of VZV (gpELISA) Antibodies|Mean VZV antibody response at 6 weeks after vaccination for participants initially seronegative (<5 gpELISA Units/mL) to VZV at baseline|6 weeks postvaccination|Analysis was performed on the per-protocol population, defined as all participants who had both pre- and post-vaccination blood samples, were seronegative at baseline, and followed all protocol procedures. Too few participants were enrolled in the study to perform non-inferiority analysis for this outcome measure.||gpELISA units/mL||90% Confidence Interval|Geometric Mean
787059|NCT00839917|Secondary|Geometric Mean Titer of Rubella Antibodies|Mean rubella antibody response at 6 weeks postvaccination for participants initially seronegative (<10 IU/mL) to rubella at baseline|6 weeks postvaccination|Analysis was performed on the per-protocol population, defined as all participants who had both pre- and post-vaccination blood samples, were seronegative at baseline, and followed all protocol procedures. Too few participants were enrolled in the study to perform non-inferiority analysis for this outcome measure.||IU/mL||90% Confidence Interval|Geometric Mean
787060|NCT00839917|Secondary|Geometric Mean Titer of Mumps Antibodies|Mean mumps antibody response at 6 weeks after vaccination for participants initially seronegative (<10 Units/mL) to mumps at baseline|6 weeks postvaccination|Analysis was performed on the per-protocol population, defined as all participants who had both pre- and post-vaccination blood samples, were seronegative at baseline, and followed all protocol procedures. Too few participants were enrolled in the study to perform non-inferiority analysis for this outcome measure.||Units/mL||90% Confidence Interval|Geometric Mean
787061|NCT00839917|Secondary|Geometric Mean Titer of Measles Antibodies|Mean measles antibody response at 6 weeks after vaccination for participants initially seronegative (<255 mIU/mL) to measles at baseline|6 weeks postvaccination|Analysis was performed on the per-protocol population, defined as all participants who had both pre- and post-vaccination blood samples, were seronegative at baseline, and followed all protocol procedures. Too few participants were enrolled in the study to perform non-inferiority analysis for this outcome measure.||mIU/mL||90% Confidence Interval|Geometric Mean
787062|NCT00839917|Primary|Percentage of Participants With Varicella-zoster Virus (VZV) Antibody Levels ≥5 Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Units/mL|Antibody response to VZV at 6 weeks after vaccination for participants initially seronegative (<5 gpELISA units/mL) to VZV at baseline|6 weeks postvaccination|Analysis was performed on the per-protocol population, defined as all participants who had both pre- and post-vaccination blood samples, were seronegative at baseline, and followed all protocol procedures. Too few participants were enrolled in the study to perform non-inferiority analysis for this outcome measure.||percentage of participants||90% Confidence Interval|Number
787063|NCT00839917|Primary|Percentage of Participants With Rubella Antibody Levels ≥10 IU/mL|Antibody response to rubella at 6 weeks after vaccination for participants initially seronegative (<10 IU/mL) to rubella at baseline|6 weeks postvaccination|Analysis was performed on the per-protocol population, defined as all participants who had both pre- and post-vaccination blood samples, were seronegative at baseline, and followed all protocol procedures. Too few participants were enrolled in the study to perform non-inferiority analysis for this outcome measure.||percentage of participants||90% Confidence Interval|Number
787064|NCT00839917|Primary|Percentage of Participants With Mumps Antibody Levels ≥10 Mumps Antibody Units/mL|Antibody response to mumps at 6 weeks after vaccination for participants initially seronegative (<10 units/mL) to mumps at baseline|6 weeks postvaccination|Analysis was performed on the per-protocol population, defined as all participants who had both pre- and post-vaccination blood samples, were seronegative at baseline, and followed all protocol procedures. Too few participants were enrolled in the study to perform non-inferiority analysis for this outcome measure.||percentage of participants||90% Confidence Interval|Number
787065|NCT00839917|Primary|Percentage of Participants With Measles Antibody Levels ≥255 mIU/mL|Antibody response to measles at 6 weeks after vaccination for participants initially seronegative (<255 mIU/mL) to measles at baseline|6 weeks postvaccination|Analysis was performed on the per-protocol population, defined as all participants who had both pre- and post-vaccination blood samples, were seronegative at baseline, and followed all protocol procedures. Too few participants were enrolled in the study to perform non-inferiority analysis for this outcome measure.||percentage of participants||90% Confidence Interval|Number
787071|NCT00839956|Secondary|Time to Disease Progression in Patients Who Progressed|Patients will be followed for initial response to therapy and for progression of disease. Response criteria will be scored according to International Myeloma Working Group uniform response criteria.|Up to 5 years|One subject withdrew from the study within first week of study therapy and changed to different therapy and is not included in this outcome measure.||years||Full Range|Median
787072|NCT00839956|Primary|Toxicity as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0|The first three months of therapy will be used as the time period in which toxicity will be evaluated and stopping rules for unacceptable toxicity will be implemented. Rules for stopping the study will be based on the rate of withdrawal due to significant toxicity (grade IV, non-hematological, non-metabolic, nonperipheral neuropathy).|The first three months of therapy|No patients met stopping rules for significant toxicity in the first three months of therapy.||Participants|||Count of Participants
787073|NCT00839982|Secondary|Overall Survival|Median overall survival|Up to 5 years|||median months||Full Range|Median
787074|NCT00839982|Secondary|Disease Free Survival|Median disease-free survival|Up to 5 years|||median months||Full Range|Median
787075|NCT00839982|Secondary|Treatment Response|CR = no evidence of leukemia with complete blood count recovery (ANC >1,000 and PLTS >100k) CRi = no evidence of leukemia but with incomplete blood count recovery|Up to 5 years|||Participants|||Count of Participants
787076|NCT00839982|Primary|Maximum Tolerated Dose|We identified 20 mg/d for 5 d as the maximum tolerated dose (MTD) of oral clofarabine.|up to 5 years|||mg/day|||Number
787077|NCT00839982|Primary|Number of Patients With Dose Limiting Toxicity|Dose limiting toxicity (DLT) consists of grade 3-4 non-hematologic toxicity at least possibly related to study drug. Exceptions include neutropenic fever; drug-related fever; alopecia; anorexia; inadequately treated nausea, vomiting and/or diarrhea; and grade 3/4 increase in ALT, AST, or bilirubin recovering to < grade 2 by 7 days. Prolonged grade 2 myelosuppression lasting longer than 49 days in patients who don't proceed to additional cytotoxic therapy is considered a DLT. The MTD or recommended phase II dose is the highest dose level at which no more than 1 patient out of 6 experiences DLT.|Outcomes by day 30|||Participants|||Count of Participants
787078|NCT00840060|Primary|Number of Verb Structures Per Utterance|Samples were transcribed and segmented by utterance. Utterances were analyzed for novel verb structures. Structures were included if they were produced more than one time.|Pre-treatment, post-treatment, 1-month follow-up|||Novel verb structures per utterance||Standard Deviation|Mean
787079|NCT00840060|Primary|Language Sample Analysis|Samples were transcribed and segmented by utterance. Each was coded categorically. Reported measures include percentage of utterances at the interpretive/inferential label, percentage of utterances with one or more t-unit (i.e., noun phrase + verb phrase), percentage of utterances that required copula (is/are) or auxiliary (is/are) that were produced.|Language samples were obtained pre-treatment, post-treatment, and at one-month follow-up.|Language samples were collected for all children participating in either treatment condition.||Percentage of utterances||Standard Deviation|Mean
787080|NCT00840073|Secondary|AUC0-72 - Trandolaprilat|Informational Purposes Only|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis. Data from two subjects who did not complete was also included in statistical analysis since the 72 hour blood draw that was missed does not affect the results for Trandolapril.||ng*h/mL||Standard Deviation|Mean
787081|NCT00840073|Secondary|Cmax - Trandolaprilat|Informational Purposes Only|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis. Data from two subjects who did not complete was also included in statistical analysis since the 72 hour blood draw that was missed does not affect the results for Trandolapril.||ng/mL||Standard Deviation|Mean
787082|NCT00840073|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis. Data from two subjects who did not complete was also included in statistical analysis since the 72 hour blood draw that was missed does not affect the results for Trandolapril.||ng*h/mL||Standard Deviation|Mean
787083|NCT00840073|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis. Not all data from completed subjects could be used to determine AUC0-inf.||ng*h/mL||Standard Deviation|Mean
787084|NCT00840073|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis. Data from two subjects who did not complete was also included in statistical analysis since the 72 hour blood draw that was missed does not affect the results for Trandolapril.||ng/mL||Standard Deviation|Mean
787085|NCT00840086|Secondary|Frequency of Adverse Events (AEs)|Adverse event was defined as events occurring after administration of trial product. Severe AEs: considerable interference with subject's daily activities, unacceptable. Moderate AEs: Marked symptoms, moderate interference with the patient’s daily activities. Mild AEs: No or transient symptoms, no interference with the patient’s daily activities. Serious AEs: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalization, persistent/significant disability/incapacity/congenital anomaly/birth defect.|The adverse events were collected throughout the trial, corresponding to an average of 188 days per subject|Safety analysis set includes all subjects who received at least one dose of the investigational product.||events|||Number
787086|NCT00840086|Primary|The Incidence Rate of FVIII Inhibitors (Greater Than or Equal to 0.6 Bethesda Units (BU))|The incidence rate of FVIII inhibitors was calculated by including all patients with inhibitors in the nominator and including all patients with a minimum 50 exposure plus any patients with less than 50 exposures but with inhibitors in denominator.|The adverse events were collected throughout the trial, corresponding to an average of 188 days per subject.|The safety analysis set includes all 150 subjects who received at least one dose of the investigational product. The analysis of the primary endpoint included all subjects with at least 50 exposure days and/or with inhibitors. A total of 148 subjects had 50 exposure days (EDs).||N with Inhibitors / N with ≥50 EDs|||Number
787091|NCT00840099|Primary|Bioequivalence Based on AUC0-inf for Amoxicillin|AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)|Blood samples collected over 14 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
787092|NCT00840099|Primary|Bioequivalence Based on Cmax for Amoxicillin|Cmax - Maximum Observed Concentration|Blood samples collected over 14 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
787093|NCT00840203|Secondary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|AUC0-t results for N-Acetylmesalamine metabolite|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
787094|NCT00840203|Secondary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|AUC0-inf results for N-Acetylmesalamine metabolite|Blood samples collected over 48 hour period|AUC0-inf was not able to be estimated for all completing subjects||ng*h/mL||Standard Deviation|Mean
787095|NCT00840203|Secondary|Cmax - Maximum Observed Concentration|Cmax results for N-Acetylmesalamine metabolite|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
787096|NCT00840203|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
787097|NCT00840203|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 48 hour period|AUC0-inf was not able to be estimated for all completing subjects||ng*h/mL||Standard Deviation|Mean
787098|NCT00840203|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
787099|NCT00840216|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration|Bioequivalence based on AUC0-t|Blood samples collected over 36 hour period|Data from subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
787100|NCT00840216|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 36 hour period|Data from subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
787101|NCT00840216|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 36 hour period|Data from subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
787102|NCT00840281|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 12 hour period.|||ng*h/mL||Standard Deviation|Mean
787103|NCT00840281|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 12 hour period.|||ng*h/mL||Standard Deviation|Mean
787104|NCT00840281|Primary|Cmax (Maximum Observed Concentration)|Bioequivalence based on Cmax.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
787105|NCT00840294|Secondary|Overall Infectious Complication Rate Following Prostate Biopsy|To assess the impact of ciprofloxacin on the overall infectious complication rate following prostate biopsy|Within 24 hours of biopsy|Subjects with complete data are included.||percentage of participants||95% Confidence Interval|Number
787106|NCT00840294|Primary|Change in PSA Level From Baseline|"To assess the impact of ciprofloxacin on the change in PSA from baseline/randomization to prostate biopsy which occurs 21-45 days after randomization.
Due to the skewness of the data, the log transformation was used and the outcome used was the log(PSA level post-treatment, at time of biopsy) - log(PSA level baseline)."|At baseline and 21-45 days after randomization|Subjects with complete data are included||log ng/mL||Standard Deviation|Mean
787107|NCT00840411|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration|Bioequivalence based on AUC0-t|Blood samples collected over 36 hour period|Data from subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
787108|NCT00840411|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 36 hour period|AUCinf could not be estimated for some subjects.||ng*h/mL||Standard Deviation|Mean
787109|NCT00840411|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 36 hour period|Data from subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
787110|NCT00840450|Secondary|Progression-free-survival at 12 Months|This defined as the percentage of participants who had progression free survival at 12 months from the beginning of the treatment.|up to 12 months|Based on intent-to-treat population.||percentage of participants|||Number
787111|NCT00840450|Secondary|Progression-free-tolerance|This is defined as the percentage of participants who continued on treatment with no progression at 12 weeks since the start of treatment.A patient will be considered to have progression-free-tolerance if she does not drop out due to toxicity and does not have disease progression or die by the completion of 12 weeks on treatment.|12 weeks|Based on intent-to-treat population.||percentage of participants|||Number
787112|NCT00840450|Primary|the Best Overall Clinical Response|This is defined as the percentage of participants who had either a complete response (CR) or a partial response (PR) as the best overall response according to Response Evaluation Criteria in Solid Tumors (RECIST) for measurable disease or CA-125 criteria for non-measurable disease. The response is evaluated at 12 weeks of treatment.|12 weeks|The analysis is based on the intent-to-treat population.||percentage of participants|||Number
787113|NCT00840476|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 96 hour period|The data from two completed subjects was not included in the statistical analysis due to pre-dose concentrations greater than 5% of the individuals Cmax value.||µg*h/mL||Standard Deviation|Mean
787114|NCT00840476|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 96 hour period|The data from two completed subjects was not included in the statistical analysis due to pre-dose concentrations greater than 5% of the individuals Cmax value.||µg*h/mL||Standard Deviation|Mean
787115|NCT00840476|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 96 hour period|The data from two completed subjects was not included in the statistical analysis due to pre-dose concentrations greater than 5% of the individuals Cmax value.||µg/mL||Standard Deviation|Mean
787116|NCT00840632|Secondary|AUC0-t - Trandolaprilat|Informational Purposes Only|Blood samples collected over 72 hour period|||pg*h/mL||Standard Deviation|Mean
787117|NCT00840632|Secondary|AUC0-inf - Trandolaprilat|Informational Purposes Only|Blood samples collected over 72 hour period|||pg*h/mL||Standard Deviation|Mean
787118|NCT00840632|Secondary|Cmax - Trandolaprilat|Informational Purposes Only|Blood samples collected over 72 hour period|||pg/mL||Standard Deviation|Mean
787119|NCT00840632|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.||pg*h/mL||Standard Deviation|Mean
787120|NCT00840632|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.||pg*h/mL||Standard Deviation|Mean
787121|NCT00840632|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.||pg/mL||Standard Deviation|Mean
787122|NCT00840658|Secondary|Change (Baseline to 4-, 8-, and 12-months) in the a) Proportional Odds of Higher Receptive Needle Sharing and b) Mean Score of the Injection Risk Index (IRI).|"For a) we asked: “In the past month, how often have you used a needle or syringe that you knew or suspected had been used before by someone else?” (possible responses: 1=never, 2=sometimes, 3=about half the time, 4=often, 5=always), with a higher response indicating a higher risk.
Analyzed using ordinal logistic regression with frequency of receptive needle sharing as outcome variable and intervention group, time point, and interaction between the two as main effects of interest.
For b)IRI calculated based on: receptive needle sharing, sharing a bottlecap/spoon/cooker, sharing cotton filter for a needle, or rinse water after someone else has used it, and using a used syringe to divide drugs. Score constructed by calculating average score between responses to injection risk indicators, with higher score representing higher risk. We analyzed using gamma regression with IRI as outcome and intervention group, time point and interaction between the two as main effects of interest"|12 months, with measuring points at baseline and at 4, 8, and 12 months past baseline||11/2012||||
787123|NCT00840658|Secondary|Change (Baseline to 4-, 8-, and 12-months) in the a)Mean Number of Unprotected Sex Acts With Clients and b)Ratio of Unprotected Sex Acts With Clients (Relative to the Number of Sex Acts With Clients.|The analytic method used for a) was negative binomial regression with the number of unprotected sex acts with clients as the outcome variable and intervention group, time point (baseline, 4-, 8-, and 12-months), and the interaction between the two as the main effects of interest. Similarly, for part b) we used negative binomial regression, except that in this case log(total number of sex acts with clients) was used as an offset variable in order to create the ratio of unprotected sex acts (relative to total number of sex acts).|12 months, with measuring points at baseline and at 4, 8, and 12 months past baseline||11/2012||||
787124|NCT00840658|Primary|Combined HIV/STI 12-month Incidence Rates of HIV, Syphilis, Chlamydia, Gonorrhea and Trichomonas Vaginalis.|"Combined incidence for HIV/STI was calculated over the 12-month study period and included only those who a) had at least one follow-up visit and b) at baseline tested negative for HIV and any of the aforementioned STIs.
In the calculations we accounted for the time each participant spent at risk of HIV/any STI during the follow-up period, by using available information on each participant for each time point (i.e. baseline, 4-, 8-, and 12-months was used).
The analytic method used for this outcome analysis was Poisson regression with robust variance estimation. The outcome variable was a binary variable indicating whether a participant has contracted HIV or a new STI during the 12-month follow-up period. The primary factor of interest was the intervention group. The log (“time spent at risk of HIV/any STI”) was used as an offset variable in order to account for the time spent at risk of HIV/any STI by each participant."|12 months, with measuring points at baseline and at 4, 8, and 12 months past baseline|||incidence density per 100 person years|||Number
787125|NCT00840840|Primary|Bioequivalence Based on AUC0-t for Clavulanic Acid|AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration|Blood samples collected over 14 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/h/mL||Standard Deviation|Mean
787126|NCT00840840|Primary|Bioequivalence Based on AUC0-inf for Clavulanic Acid|AUC0-inf - Area under the concentration-time curve from zero to infinity (extrapolated)|Blood samples collected over 14 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
787127|NCT00840840|Primary|Bioequivalence Based on Cmax for Clavulanic Acid|Cmax - Maximum Observed Concentration|Blood samples collected over 14 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
787128|NCT00840840|Primary|Bioequivalence Based on AUC0-t for Amoxicillin|AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration|Blood samples collected over 14 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
787129|NCT00840840|Primary|Bioequivalence Based on AUC0-inf for Amoxicillin|AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)|Blood samples collected over 14 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
787130|NCT00840840|Primary|Bioequivalence Based on Cmax for Amoxicillin|Cmax - Maximum Observed Concentration|Blood samples collected over 14 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
787134|NCT00840879|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 96 hour period|One subject had a pre-dose concentration greater than 5% of the individuals Cmax value and was excluded from the statistical analysis. Data from all other subjects who completed the study was used in the statistical analysis.||µg*h/mL||Standard Deviation|Mean
787135|NCT00840879|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 96 hour period|One subject had a pre-dose concentration greater than 5% of the individuals Cmax value and was excluded from the statistical analysis. Data from all other subjects who completed the study was used in the statistical analysis.||µg*h/mL||Standard Deviation|Mean
787136|NCT00840879|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 96 hour period|One subject had a pre-dose concentration greater than 5% of the individuals Cmax value and was excluded from the statistical analysis. Data from all other subjects who completed the study was used in the statistical analysis.||µg/mL||Standard Deviation|Mean
787137|NCT00840996|Secondary|12-item Short Form Survey (SF-12) Physical Health Composite Score|Physical health composite score ranges from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.|90 days post operative|Include the participants who finished the Acute SF 12 health survey at 90 days follow-up||units on a scale||Inter-Quartile Range|Median
787138|NCT00840996|Secondary|12-item Short Form Survey (SF-12) Physical Health Composite Score|Physical health composite score ranges from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.|30 days post operative|Include the participants who finished the Acute SF 12 health survey at 30 days follow-up||units on a scale||Inter-Quartile Range|Median
787139|NCT00840996|Secondary|Duration of Hospitalization|Length of hospital stay will be recorded in days.|At discharge|3 patients in the placebo group did not have duration of hospital stay recorded.||days||Inter-Quartile Range|Median
787140|NCT00840996|Secondary|Postoperative Nausea and Vomiting (PONV)|Postoperative Nausea and Vomiting (PONV)will be noted during day one and day two postoperative.|post op day one and two or till hospital discharge|We only have 39 and 36 patients for comparison of PONV at day two after surgery, since the rest were discharged by that time||participants|||Number
787141|NCT00840996|Secondary|Number of Participants With Any Major 30-day Post Operative Complications|The occurrence in an individual of one or more the following major complications, including pneumonia, respiratory failure, prolonged use or need for reinsertion of chest tube, cardiac arrest, arrhythmia, congestive heart failure, stroke, intravascular coagulopathy, thromboembolic disease (pulmonary embolism), injury to great vessels, delirium, monoplegia or paraplegia, upper gastrointestinal bleeding, gastrointestinal block, ureteral obstruction, syndrome of inappropriate antidiruretic hormone secretion, wound infection requiring debridement, sepsis, and readmission.|30 days after surgery|||participants|||Number
787142|NCT00840996|Primary|Opioid Medication Requirement, mg in IV Morphine Equivalent|Opioid consumption during the initial 48 postoperative hours was converted to IV morphine sulfate equivalents|through postoperative day 2 (or discharge, if earlier)|||mg IV morphine equivalent||Standard Deviation|Mean
787143|NCT00840996|Primary|Mean Pain Scores|The pain score as measured by verbal response scores (scale ranging from 0 to 10 with 0=no pain; 10=worst pain) every 30 minutes during post anesthesia care unit stay, then per nursing floor protocol (roughly every 4-6 hours).|From admission to the post anesthesia care unit through postoperative day 2 (or discharge, if earlier).|||verbal response scores||Standard Deviation|Mean
787144|NCT00841035|Primary|Epidermal Growth Factor Receptor Signaling(EGFR) in the Presence of Pancreatic Tumor Related to the Mechanism to Erlotinib.|It was our belief that we would need a comprehensive analysis of a dynamic panel of biomarkers relevant to EGFR signaling as well as the erlotinib mechanism of action it seems more useful in that sense. Furthermore,the ability limited of pancreatic cancer tissue sampling precluded biomarker correlation assays.These could not be worked out in either a xenograft model or in in-vitro conditions.|During the trial only||||||
787145|NCT00841035|Secondary|The Secondary Objectives Include Analysis of Recurrence-free and Overall Survival and the Development of a Predictive Assay for Response to Erlotinib Based on Selected Bio-markers in Endoscopic Ultrasound-Fine-needle Aspiration Specimens.|The measurement was to be the average length of time before recurrence of disease and the overall survival time. As well as time from recurrence to death in subjects.This time will be measure in months till recurrence and them months to death.|End of the study|Due to the closure of the study before this endpoint could be met, there are no subjects analyzed.|||||
787146|NCT00841087|Secondary|Systolic Blood Pressure (BP)|Mean values at baseline (Week 0) and at Week 6|Week 0, Week 6|Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.||mmHg||Standard Deviation|Mean
787147|NCT00841087|Secondary|Diastolic Blood Pressure (BP)|Mean values at baseline (Week 0) and at Week 6|Week 0, Week 6|Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.||mmHg||Standard Deviation|Mean
787148|NCT00841087|Secondary|Electrocardiogram (ECG)|The number of subjects having a electrocardiogram (ECG) that changed from 'Normal' or 'Abnormal, not clinically significant' to 'Abnormal, clinically significant'. 'Abnormal, Clinically significant' is an abnormality that suggests a disease and/or organ toxicity and is of a severity, which requires active management.|Week 0, Week 6|The Safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||participants|||Number
787149|NCT00841087|Secondary|Change in Body Weight|Observed change from baseline in body weight after 6 weeks of treatment|Week 0, Week 6|The Safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||kg||Standard Deviation|Mean
787198|NCT00848926|Secondary|Complete Remission Rate by Independent Review Group|Percentage of participants who achieved a best response of CR (disappearance of all evidence of disease) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.|up to 12 months|Intention to treat||percent of participants||95% Confidence Interval|Number
787380|NCT00850174|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Oxcarbazepine|Bioequivalence based on AUC0-t|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
787150|NCT00841087|Secondary|Number of Treatment Emergent Adverse Events (AEs)|Corresponds to number of adverse events. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject’s daily activities. Moderate: marked symptoms, moderate interference with subject’s daily activities. Severe: considerable interference with subject’s daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.|Week 0 to Week 6 + 5 days follow up|The Safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||events|||Number
787151|NCT00841087|Primary|Rate of Nocturnal Major and Minor Hypoglycaemic Episodes|Observed rate of nocturnal major and minor hypoglycaemic episodes per patient year (1year=365.25days) of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose ≤ 55 mg/dL. Episodes were defined as nocturnal if the time of onset was between 23:00−05:59 (both inclusive).|Week 0 to Week 6 + 5 days follow up|The Safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||Episodes /year of patient exposure|||Number
787152|NCT00841087|Primary|Rate of Major and Minor Hypoglycaemic Episodes|Observed rate of major and minor hypoglycaemic episodes per patient year (1year=365.25days) of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose ≤ 55 mg/dL.|Week 0 to Week 6 + 5 days follow up|The Safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||Episodes /year of patient exposure|||Number
787153|NCT00841204|Primary|Sulindac Sulfide, an Active Metabolite of Sulindac, Concentration in the Nevi||8 weeks|All randomized participants were included in the analysis except one participant in the sulindac arm did not provide nevi sample for analysis||µg/g tissue||Standard Deviation|Mean
787154|NCT00841204|Primary|Sulindac Sulfone, an Active Metabolite of Sulindac, Concentration in the Nevi||8 weeks|All randomized participants were included in the analysis except one participant in the sulindac arm did not provide nevi sample for analysis||µg/g tissue||Standard Deviation|Mean
787155|NCT00841204|Primary|Sulindac Concentration in the Nevi (Moles)||8 weeks|All randomized participants were included in the analysis except one participant in the sulindac arm did not provide nevi sample for analysis||µg/g tissue||Standard Deviation|Mean
787156|NCT00841204|Secondary|Association Between Plasma and Target Tissue Drug Levels||8 weeks||||||
787157|NCT00841204|Secondary|Sulindac Effects on Vascular Endothelial Growth Factor (VEGF) Expression in Atypical Nevi||8 weeks||||||
787158|NCT00841204|Secondary|Sulindac Effects on Apoptosis in Atypical Nevi||8 weeks||||||
787159|NCT00848484|Secondary|Mean Change From Baseline After 2 Weeks of Treatment in the Attention/Processing Speed Composite Score|The Attention/Processing Speed Composite Score was comprised of the following tests: Identification Task and the Detection Task from the CogState Schizophrenia Battery and the Symbol Coding test from the BACS. The composite score was calculated by averaging all of the available standardized tests scores for the specified tests. The possible minimum and maximum scores for change from baseline at two weeks of treatment for the endpoint are -287.15 and 287.15, respectively.|Baseline and Week 2|Full Analysis Set (FAS): The FAS population was a subset of all randomized patients which included randomized patients who received at least one dose of study treatment and had at least one measurement in any of the two treatment periods.||T-score based on normative data||95% Confidence Interval|Least Squares Mean
787160|NCT00848484|Secondary|Mean Change From Baseline After 2 Weeks of Treatment in the Working Memory Composite Score|The Working Memory Composite Score was comprised of the following tests: Two-Back Memory Task from the CogState Schizophrenia Battery and the Digit Sequencing test from the BACS. The composite score was calculated by averaging all of the available standardized tests scores for the specified tests. The possible minimum and maximum scores for change from baseline at two weeks of treatment for the endpoint are -27.06 and 27.06, respectively.|Baseline and Week 2|Full Analysis Set (FAS): The FAS population was a subset of all randomized patients which included randomized patients who received at least one dose of study treatment and had at least one measurement in any of the two treatment periods.||T-score based on normative data||95% Confidence Interval|Least Squares Mean
787161|NCT00848484|Secondary|Mean Change From Baseline After 2 Weeks of Treatment in the Episodic Memory Composite Score|The Episodic Memory Composite Score was comprised of the following tests: Continuous Paired Associate Learning Task and One Card Learning Task from the CogState Schizophrenia Battery and the Verbal Memory test from the BACS. The composite score was calculated by averaging all of the available standardized tests scores for the specified tests. The possible minimum and maximum scores for change from baseline at two weeks of treatment for the endpoint are -207.06 and 207.06, respectively.|Baseline and Week 2|Full Analysis Set (FAS): The FAS population was a subset of all randomized patients which included randomized patients who received at least one dose of study treatment and had at least one measurement in any of the two treatment periods.||T-score based on normative data||95% Confidence Interval|Least Squares Mean
787162|NCT00848484|Secondary|Mean Change From Baseline After 2 Weeks of Treatment in the Executive Functioning Composite Score|The Executive Functioning Composite Score was comprised of the following tests: Groton Maze Learning Task from the CogState Schizophrenia Battery and Tower of London, Semantic Fluency and Letter Fluency tests from the BACS. The composite score was calculated by averaging all of the available standardized tests scores for the specified tests. The possible minimum and maximum scores for change from baseline at two weeks of treatment for the endpoint are -253.4 and 253.4, respectively.|Baseline and Week 2|Full Analysis Set (FAS): The FAS population was a subset of all randomized patients which included randomized patients who received at least one dose of study treatment and had at least one measurement in any of the two treatment periods.||T-score based on normative data||95% Confidence Interval|Least Squares Mean
787199|NCT00848926|Primary|Objective Response Rate by Independent Review Group|Percentage of participants who achieved a best response of complete remission (CR, disappearance of all evidence of disease) or partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.|up to 12 months|Intention to treat||percent of participants||95% Confidence Interval|Number
787528|NCT00844194|Secondary|Number of Patients With a Reduction in BPI Average Pain at Week 12||Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Participants|||Number
787163|NCT00848484|Secondary|Mean Change From Baseline After 2 Weeks of Treatment in the CogState Composite Score|CogState Schizophrenia Battery was used to evaluate cognitive impairment, as measured by the mean change from baseline after 2 weeks of treatment in the composite score. The composite score was comprised of 4 modules from the CogState Schizophrenia Battery: Identification Task, Detection Task, One Card Learning Task and Groton Maze Learning Task. Composite score was calculated by averaging all available standardized tests scores for the specified tests. The possible minimum and maximum scores for change from baseline at 2 weeks of treatment for the endpoint are -347.5 and 347.5, respectively.|Baseline and week 2|Full Analysis Set (FAS): The FAS population was a subset of all randomized patients which included randomized patients who received at least one dose of study treatment and had at least one measurement in any of the two treatment periods.||T-score based on normative data||95% Confidence Interval|Least Squares Mean
787164|NCT00848484|Primary|Mean Change From Baseline in the Composite Score From the Brief Assessment of Cognition in Schizophrenia (BACS) Battery After 2 Weeks of Treatment|The Brief Assessment of Cognition in Schizophrenia (BACS) was used to evaluate cognitive impairment, as measured by the mean change from baseline after 2 weeks of treatment in the composite score. The BACS composite score was calculated by averaging scores from the BACS subtests, including Verbal Memory, Digit Sequencing, Token Motor, Symbol Coding, Verbal Fluency (Semantic Fluency and Letter Fluency) and Tower of London. The possible minimum and maximum scores for change from baseline at two weeks of treatment for the endpoint are -111.5 and 111.5, respectively.|Baseline and Week 2|Full Analysis Set (FAS): The FAS population was a subset of all randomized patients which included randomized patients who received at least one dose of study treatment and had at least one measurement in any of the two treatment periods.||T-score based on normative data||95% Confidence Interval|Least Squares Mean
787165|NCT00848497|Secondary|Change in the EPIC (Expanded Prostate Cancer Index Composite) Score 6 Months After the Initial Screening Visit.|EPIC is scored from 0 -100,lower EPIC score= worse, higher EPIC score= better|Basline and 6 months|"Baseline = 98
5 months = 87"||units on a scale|||Number
787166|NCT00848497|Secondary|Change in the ADAM (Androgen Deficiency in the Aging Male)Score 6 Months After the Initial Screening Visit.|ADAM scores of one evaluated patient. ADAM is 10 questions (“yes” or “no” answers) and if you answer yes to question 1 or 7 or “yes” to any 3 questions you are said to test “positive” to the ADAM questionnaire.|Baseline and 6 months|Baseline = Positive 5 months = Positive||number of yes answers|||Number
787167|NCT00848497|Secondary|Change in the IIEF (International Index of Erectile Function) Score 6 Months After the Initial Screening Visit.|There are 15 questions, each divided into 5 domains. Maximum score is 75 = best function, and minimum is 5 = worst function|Baseline and 6 months|Baseline = 5 5 months = 6||units on a scale|||Number
787168|NCT00848497|Primary|Change in SHIM (Sexual Health Inventory for Males) Score at 6 Months After Initial Screening Visit.|SHIM range is 0-25. 0= no sexual activity;1-7 severe ED; 8-11 Moderate ED; 12-16 Mild to Moderate ED; 17-21 Mild ED|Baseline and 6 months|Baseline = 0 5 months = 0||units on a scale|||Number
787169|NCT00848510|Secondary|Progression-Free Survival (PFS) Time|PFS was defined as the time from first study drug intake until radiological progression (based on RECIST Version 1.0) or death due to any cause. Only deaths within 84 days of last tumor assessment are considered. Subjects without event were censored on the date of last tumor assessment. Investigator read was the assessment of all imaging by the treating physician at the local trial site.|Time from first study drug intake to disease progression, death or last tumor assessment until end of trial visit (4 weeks after last dose administration)|The safety analysis set included all subjects who received at least one dose of IMP administration.||months||Full Range|Median
787170|NCT00848510|Primary|Whole Tumor Volume and Enhancing Tumor Volume|Tumor volume (three-dimensional measurement) and the enhancing fraction of the tumor, which provides a gross measure of the proportion of the tumor that has a measurable level of perfusion, were assessed using DCE-MRI.|Screening 1, screening 2, Week 1 Day 2, Week 1 Day 5, and Week 2 Day 1|The DCE-MRI analysis set included all subjects who had at least one valid predose scan and at least one valid postdose (that is, after the infusion) scan.||Cubic millimeter (mm^3)||Standard Deviation|Mean
787171|NCT00848510|Primary|Initial Area Under the DCE-MRI Contrast Agent Concentration Time Curve After 60 Seconds (IAUC60)|IAUC 60 was used to give a gross indication of the delivery and uptake of contrast agent within the tumor (indicating the degree of perfusion and endothelial permeability. IAUC60 was measured using DCE-MRI.|Screening 1, screening 2, Week 1 Day 2, Week 1 Day 5, and Week 2 Day 1|The DCE-MRI analysis set included all subjects who had at least one valid predose scan and at least one valid postdose (that is, after the infusion) scan.||(Millimoles/liter)*sec||Standard Deviation|Mean
787172|NCT00848510|Primary|Blood Plasma Volume and Extravascular/Extracellular Volume|Blood plasma volume and extracellular/extravascular volume was measured using DCE-MRI.|Screening 1, screening 2, Week 1 Day 2, Week 1 Day 5, and Week 2 Day 1|The DCE-MRI analysis set included all subjects who had at least one valid predose scan and at least one valid postdose (that is, after the infusion) scan.||milliliter||Standard Deviation|Mean
787173|NCT00848510|Secondary|Number of Subjects With Positive Binding Abituzumab Antibodies|Subjects were defined as abituzumab positive if at least one positive result of antibodies against abituzumab was observed. In all other cases, subjects were defined as abituzumab negative.|Day 1 of Weeks 1, 3, 5, 6, 7, 8, and week 11 and end of study (EOS) visit (4 weeks after last dose administration)|"The immunogenicity analysis set included all subjects who received at least one dose of study drug administration and provided sufficient data from the antibodies samples. 'N' (number of subjects analyzed) signifies the subjects evaluable for this outcome measure. n signifies the number of subjects evaluable for each time point, respectively."||Subjects|||Number
787174|NCT00848510|Secondary|Number of Subjects With Worsened Post Baseline Shift in ECOG Performance Status Score|The number of subjects who experienced worse post baseline shift were assessed as per ECOG performance status score recorded during the treatment. The ECOG score is categorized as Grade 0, 1, 2, 3 and 4 where Grade 0=fully active, Grade 1=restricted in physically strenuous activity, Grade 2=unable to carry out any work activities, Grade 3=capable of only limited self-care and Grade 4=completely disabled.|Up to 4 weeks after last dose administration|The safety analysis set included all subjects who received at least one dose of IMP administration.||Subjects|||Number
787448|NCT00844194|Secondary|Change of Fasting Blood Glucose From Baseline at Week 12|Ancova analysis controlling for baseline and insulin intake|Baseline and Week 12|All patients receiving at least one dose of study medication and having data of fasting blood glucose at baseline and at week 12.||mg/dL||95% Confidence Interval|Least Squares Mean
787175|NCT00848510|Secondary|Number of Subjects With Best Overall Response, Tumor Response and Clinical Benefit|Tumor response was assessed by the Investigator, based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 criteria. Tumor response was defined as the presence of a “best overall response” of complete response (CR) or partial response (PR). CR: Disappearance of all target and non-target lesions and/or normalization of serum levels of tumor markers. PR: At least a 30 percent decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of the LD of target lesions. The qualification of a CR or of a PR needed a confirmation by a second computed tomography (CT) scan at least 4 weeks after the first scan. Best overall response was derived programmatically as the best response recorded from the first investigation medicinal product administration until disease progression. Clinical benefit was defined as the presence of a “best overall response” of complete response or partial response or stable disease lasting at least 6 weeks.|Up to 4 years|The full analysis set included all subjects who received at least one dose of IMP administration. “N” signifies the total number of participants evaluable for this outcome measure. Same subjects may be reported in more than one category.||Subjects|||Number
787176|NCT00848510|Secondary|Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death|An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/ significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs were the AEs that occurred between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|From the initiation of the trial treatment until 30 days after last administration of trial treatment.|The safety analysis set included all subjects who received at least one dose of IMP administration.||Subjects|||Number
787177|NCT00848510|Primary|Volume Transfer Coefficient of Contrast Agent Across the Capillary Walls|Volume transfer coefficient was defined as the volume transfer coefficient of contrast agent across the capillary wall, reflecting endothelial permeability and blood flow. Volumetric transfer coefficient was measured by dynamic contrast enhanced magnetic resonance imaging (DCE-MRI). DCE-MRI is a noninvasive quantitative method of investigating microvascular structure and function by tracking the pharmacokinetics of injected low molecular weight contrast agents as they pass through tumor vasculature.|Screening 1, screening 2, Week 1 Day 2, Week 1 Day 5, and Week 2 Day 1|The DCE-MRI analysis set included all subjects who had at least one valid predose scan and at least one valid postdose (that is, after the infusion) scan.||min^-1||Standard Deviation|Mean
787178|NCT00848510|Primary|Number of Subjects With Dose Limiting Toxicities (DLTs)|Toxicity was graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. A DLT was defined as any Grade 3 or 4 haematological or non-haematological toxicity occurring during the first 4 weeks of treatment (that is, until the beginning of Week 5, with the exception of Grade 3 asymptomatic increase in liver function tests (aspartate aminotransferase [AST], alanine aminotransferase [ALT], and alkaline phosphatase [ALP]) returning to Baseline within 7 days.), at any dose level, for which a causal relationship to the investigative medicinal product could not be ruled out by the Investigator and/or the Sponsor.|Up to Week 4|Dose escalation analysis set included all subjects in the safety analysis set who experienced any DLT during the DLT observation period, regardless of the number of investigational medicinal product (IMP) administrations and subjects who received the IMP at Weeks 1, 3, and 5 for Cohort 1 and at Weeks 1 and 3 for all other cohorts.||Subjects|||Number
787179|NCT00848536|Primary|Mean Intraocular Pressure at 4:00 pm|"For an individual patient, two consecutive IOP measurements for each eye were taken. The mean IOP values for each individual patient's eye were rounded up to the next whole number if the value was ≥ 0.5 mmHg
All IOP measurements were performed with a Goldmann applanation tonometer. All IOP measurements for any individual subject were to be performed preferably by the same operator using the same tonometer.
Mean IOP for the patient's worse eye at baseline was used in the primary endpoint analysis. If both eyes were equal, then the right eye was selected for analysis"|3 months (measured at 4:00 pm)|Per-Protocol. Patients who received study medication, satisfied pre-randomization criteria and satisfied protocol criteria at the specific time point were considered evaluable for PP analysis.||mmHg||Standard Error|Least Squares Mean
787180|NCT00848536|Primary|Mean Intraocular Pressure at 11:00 am|"For an individual patient, two consecutive IOP measurements for each eye were taken. The mean IOP values for each individual patient's eye were rounded up to the next whole number if the value was ≥ 0.5 mmHg
All IOP measurements were performed with a Goldmann applanation tonometer. All IOP measurements for any individual subject were to be performed preferably by the same operator using the same tonometer.
Mean IOP for the patient's worse eye at baseline was used in the primary endpoint analysis. If both eyes were equal, then the right eye was selected for analysis"|3 months (measured at 11:00 am)|Per-Protocol. Patients who received study medication, satisfied pre-randomization criteria and satisfied protocol criteria at the specific time point were considered evaluable for PP analysis.||mmHg||Standard Error|Least Squares Mean
787181|NCT00848536|Primary|Mean Intraocular Pressure at 9:00 am|"For an individual patient, two consecutive IOP measurements for each eye were taken. The mean IOP values for each individual patient’s eye were rounded up to the next whole number if the value was ≥ 0.5 mmHg
All IOP measurements were performed with a Goldmann applanation tonometer. All IOP measurements for any individual subject were to be performed preferably by the same operator using the same tonometer.
Mean IOP for the patient’s worse eye at baseline was used in the primary endpoint analysis. If both eyes were equal, then the right eye was selected for analysis"|3 months (measured at 9:00 am)|Per-Protocol. Patients who received study medication, satisfied pre-randomization criteria and satisfied protocol criteria at the specific time point were considered evaluable for PP analysis.||mmHg||Standard Error|Least Squares Mean
787233|NCT00849121|Secondary|The Number of Participants Who Are Metastasis-free at One Year.|The number of subjects who are metastatic-free at one year after starting study treatment will be tabulated for each arm. CT Scans and Bone Scans will be obtained at one year to determine whether metastatic disease is present.|one year from study entry|||participants|||Number
787393|NCT00850395|Secondary|Physician's Assessment of Efficacy|Number of participants with each grade of efficacy as assessed by the physician was reported on the 5 point categorical scale: excellent, very good, good, fair, poor.|Month 12|FAS population included all participants who received at least one dose (including partial doses) of study medication.||participants|||Number
787182|NCT00848549|Secondary|Change From Baseline in Quality of Life Assessed by Quality of Life in Epilepsy-Problems Questionnaire (QOLIE-31-P) Overall Score at Each Visit|The QOLIE-31-P is a 31-item questionnaire evaluating a participant's QOL perception in 7 domains: seizure worry,emotional well being,energy/fatigue, cognitive functioning, medication effects, social functioning,overall QOL. The overall score is derived by weighing and then summing the 7 domain scores. Precoded numeric values for some domains are such that a higher number reflects a more favorable health state; others are such that a higher number reflects a less favorable state. Precoded values are converted to 0-100 point scores; higher converted scores always reflect better QOL.|Weeks 0, 26, 52, 78 and 117|ITT Population||Score on a scale||Standard Deviation|Mean
787183|NCT00848549|Secondary|Percentage of Participants That Are Seizure Free for at Least 24 Month Consecutive Period in the Base Study and Extension Phase|The number of participants that have remained seizure free for at least a 24 month consecutive period from the start of the Flexible Dosing Period (FDP: the period following the Titration Period and leading into the Maintenance Period) in the base study through the treatment period of this study. Seizure freedom was defined as the absence of all seizure regardless of seizure type.|Week 5 to Week 109 (in base study) and Month 1 to Month 27 (in extension phase)|310 ITT Population||Percentage of Participants||95% Confidence Interval|Number
787184|NCT00848549|Secondary|Time to Drop-out Due to Adverse Event (AE)|"Adverse events in study subjects included any change in the subject’s condition.
This includes symptoms, physical findings, or clinical syndromes. All AEs that occurred after signing of informed consent through the last visit and for 15 days following study drug discontinuation were captured on the AE Case Report Form (CRF)."|Week 1 to Week 109 (in base study) and Month 1 to Month 27 (in extension study)|310 ITT Population (33 participants were discontinued in the Zonisamide arm and 35 were discontinued in the Carbamazepine arm; these were the participants evaluated for this outcome)||Days||Standard Deviation|Mean
787185|NCT00848549|Secondary|Time to Drop-out Due to Lack of Efficacy|Lack of efficacy was if the subject had poor seizure control (defined as experiencing a seizure despite being on the maximum dose for = 2 weeks). The subject could withdraw at any time due to lack of efficacy.|Week 1 to Week 109 (in core study) and Month 1 to Month 27 (in extension study)|310 ITT Population (combined ITT Population from basecore study and extension phase). 24 participants were discontinued in each arm due to lack of efficacy; these were the participants that were evaluated in this outcome.||Days||Standard Deviation|Mean
787186|NCT00848549|Primary|Percentage of Participants Remaining in the Study at Each Visit|The retention rate is defined as the percentage of subjects remaining on the study at each visit, starting from the first dose of study drug in the extension phase.|At 3, 6, 9, 12, 15, 18, 21, 24, and 27 months|The Intent-to-Treat (ITT) Population is defined as all subjects who received at least one dose of investigational product(IP)||Percentage of Participants||95% Confidence Interval|Number
787187|NCT00848926|Secondary|Time of Maximum Serum Concentration|Time of maximum serum concentration from 0 to 21 days following the first dose of brentuximab vedotin|3 weeks|All participants who received treatment||days||Full Range|Median
787188|NCT00848926|Secondary|Maximum Serum Concentration|Maximum serum concentration from 0 to 21 days following the first dose of brentuximab vedotin|3 weeks|All participants who received treatment||microgram/mL||Geometric Coefficient of Variation|Geometric Mean
787189|NCT00848926|Other Pre-specified|B Symptom Resolution|Percentage of participants with lymphoma-related symptoms (B symptoms: fever, night sweats, or weight loss >10%) at baseline who achieved resolution of all B symptoms at any time during the treatment period.|up to 12 months|Participants with B symptoms at baseline||percent of participants||95% Confidence Interval|Number
787190|NCT00848926|Secondary|Area Under the Curve|Area under the serum concentration-time curve from time 0 to 21 days following the first dose of brentuximab vedotin|3 weeks|All participants who received treatment||day * microgram/mL||Geometric Coefficient of Variation|Geometric Mean
787191|NCT00848926|Secondary|Chemistry Laboratory Abnormalities >/= Grade 3|Counts of study participants with post-baseline chemistry laboratory abnormalities of Grade 3 or greater per NCI CTCAE version 3.0. Participants with multiple occurrences of a laboratory abnormality within a category are counted once in that category.|up to 12 months|All participants who received treatment||participants|||Number
787192|NCT00848926|Secondary|Hematology Laboratory Abnormalities >/= Grade 3|Counts of study participants with post-baseline hematology laboratory abnormalities of Grade 3 or greater per NCI CTCAE version 3.0. Participants with multiple occurrences of a laboratory abnormality within a category are counted once in that category.|up to 12 months|All participants who received treatment||participants|||Number
787193|NCT00848926|Secondary|Adverse Events by Severity, Seriousness, and Relationship to Treatment|Counts of participants who had adverse events or treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose). Serious adverse events are reported from the time of informed consent. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death). Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an adverse event within a category are counted once within the category.|up to 12 months|All participants who received treatment||participants|||Number
787194|NCT00848926|Secondary|Overall Survival|Time from start of study treatment to date of death due to any cause.|up to approximately 6 years|Intention to treat||months||95% Confidence Interval|Median
787195|NCT00848926|Secondary|Progression-free Survival by Kaplan-Meier Analysis|Time from start of study treatment to disease progression per independent review group or death due to any cause.|up to approximately 4 years|Intention to treat||months||95% Confidence Interval|Median
787196|NCT00848926|Secondary|Duration of Objective Response in Participants With Complete Remission by Kaplan-Meier Analysis|Duration of response from start of first objective tumor response (CR or PR) by independent review group to disease progression or death due to any cause in participants with CR.|up to approximately 4 years|Participants with complete remission among the intention to treat population||months||95% Confidence Interval|Median
787197|NCT00848926|Secondary|Duration of Objective Response by Kaplan-Meier Analysis|Duration of objective response (CR + PR) by independent review group, defined as time of initial response until disease progression or death.|up to approximately 4 years|Participants with objective response among the intention to treat population||months||95% Confidence Interval|Median
787200|NCT00848965|Secondary|Glucocorticoid (GC) Receptor Biomarker Levels in Nasal Epithelial Scraping Samples: 18S, B-actin, DUSP_1_T1, FKBP5, GAPDH, GILZ, PLAU, PTGS2, and RGS2|AROS Applied Biotechnology (AB) analyzed the nasal epithelial scrapings of participants and generated TaqMan (type of chemistry developed by AB to detect polymerase chain reaction [PCR] products) messenger ribonucleic acid (mRNA) biomarker expression data for 7 steroid-responsive genes (DUSP_1_TI, FKBP5, GILZ, PLAU, CCL2, PTGS2, and RGS2) and 3 housekeeping reference genes (GAPDH, 18S, and b-actin). Preliminary analysis of the mRNA abundance data was performed by Discovery Statistics. mRNA abundance data were normalized to the scores of GAPDH and 18S housekeeping genes. B-actin was not used.|Day 1 (pre-dose) and Day 8 of each study period (Periods 1-4); up to Day 158|All Subjects Population. The data presented are an average of the data collected on Day 1 and Day 8 of each treatment period. Only those participants contributing data at the indicated time points were analyzed.||RNA copies detected per 50 ng total RNA||95% Confidence Interval|Geometric Mean
787201|NCT00848965|Secondary|Glucocorticoid (GC) Receptor Biomarker Levels in Nasal Epithelial Scraping Samples: CCL2|AROS Applied Biotechnology (AB) analyzed the nasal epithelial scrapings of participants and generated TaqMan (type of chemistry developed by AB to detect polymerase chain reaction [PCR] products) messenger ribonucleic acid (mRNA) biomarker expression data for CCL2, a steroid-responsive gene. Preliminary analysis of the mRNA abundance data was performed by Discovery Statistics. mRNA abundance data were normalized to the scores of GAPDH and 18S housekeeping genes. B-actin was not used. CCL2 data are presented by period to show the treatment-by-period interaction. ng, nanograms.|Day 1 (pre-dose) and Day 8 of each study period (Periods 1-4); up to Day 158|All Subjects Population. The data presented for each period are an average of the data collected on Day 1 and Day 8 of each period. Only those participants contributing data at the indicated time points were analyzed.||Copies of RNA detected per 50ng of total||95% Confidence Interval|Geometric Mean
787202|NCT00848965|Secondary|Weighted Mean Global Symptom Score (GSS) at 5 Hours Post-dose (1-4 Hours Post-start of Challenge)|GSS (total score=0-30) is calculated as the sum of sneeze, nasal itch, rhinorrhea, nasal obstruction, cough, itchy throat, itchy ears, watery eyes, itchy eyes, and red eyes SSs, each of which was scored on a categorical scale from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), as was measured at pre-challenge, and then every 15 mins from 0.25 to 4 hours post-start of challenge chamber. Weighted mean global symptom score was evaluated by dividing the value of the area under the response time curve between 1 and 4 hours (calculated by trapezoidal rule) by the time interval of available data.|Day 8 of each study period (Periods 1-4); up to Day 158|All Subjects Population. Only those participants contributing data at the indicated time points were analyzed.||scores on a scale||Standard Deviation|Mean
787203|NCT00848965|Secondary|Weighted Mean Eye Symptom Score at 2-5 Hours Post-dose (1-4 Hours Post-start of Challenge)|The eye symptom score (total score of 0 [none] to 9 [severe]) was calculated as the sum of the symptom scores for watery eyes, itchy eyes, and red eyes, each of which was scored on a categorical scale from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), and was measured at pre-challenge, and then every 15 minutes from 0.25 to 4 hours post-start of challenge chamber. Weighted mean eye symptom score was calculated by dividing the value of the area under the response time curve between 1 and 4 hours (calculated by trapezoidal rule) by the time interval of available data.|Day 8 of each study period (Periods 1-4); up to Day 158|All Subjects Population. Only those participants contributing data at the indicated time points were analyzed.||scores on a scale||Standard Deviation|Mean
787204|NCT00848965|Secondary|Weighted Mean Nasal Secretion at 2-5 Hours Post-dose (1-4 Hours Post-start of Challenge)|Nasal secretion was measured by weighing tissues used by participants. Wet tissue weight assessments were made pre-challenge, and then every 30 minutes from 0.5 to 4 hours post start of challenge chamber throughout the study. Weighted mean nasal secretion was calculated by dividing the value of the area under the response time curve between 1 and 4 hours (calculated by trapezoidal rule) by the time interval of available data.|Day 8 of each study period (Periods 1-4); up to Day 158|All Subjects Population. Only those participants contributing data at the indicated time points were analyzed.||grams (g)||Standard Deviation|Mean
787205|NCT00848965|Secondary|Weighted Mean Nasal Airflow at 2-5 Hours Post-dose (1-4 Hours Post-start of Challenge)|Allergic rhinitis decreases the passage of air through the nose (nasal airflow) by increasing the nasal airway resistance. Rhinomanometry is used as an objective measurement of airway resistance. Nasal airflow was measured using active anterior rhinomanometry at pre-challenge, and then every 30 minutes from 0.5 to 4 hours post start of VCC. Weighted mean nasal airflow was calculated by dividing the value of the area under the response time curve between 1 and 4 hours (calculated by trapezoidal rule) by the time interval of available data.|Day 8 of each study period (Periods 1-4); up to Day 158|All Subjects Population. Only those participants contributing data at the indicated time points were analyzed.||Milliliters per second (mL/s)||Standard Deviation|Mean
787206|NCT00848965|Primary|Weighted Mean Total Nasal Symptom Score (TNSS) at 2-5 Hours Post-dose (1-4 Hours Post-start of Challenge [PSC]) in the Vienna Challenge Chamber (VCC)|The TNSS (score of 0-12), defined as the sum of the symptom scores for nasal obstruction, rhinorrhea, nasal itch, and sneeze (each scored on 0-3 scale [0=none, 1=mild, 2=moderate, 3=severe]) was measured at pre-challenge, and then every 15 minutes from 0.25 to 4 hours PSC. In the VCC, aerosolized allergen is administered in a sealed chamber to evaluate the efficacy of antihistamines/other treatments. Weighted mean TNSS was calculated by dividing the value of the area under the response time curve between 1 and 4 hours (calculated by trapezoidal rule) by the time interval of available data.|Day 8 of each study period (Periods 1-4); up to Day 158|All Subjects Population: all participants randomized to receive at least one dose of study treatment. Only those participants contributing data at the indicated time points were analyzed.||scores on a scale||Standard Deviation|Mean
787207|NCT00849017|Secondary|Albiglutide Plasma Concentration at Weeks 8 and 24|Albiglutide plasma concentration data was analyzed at Week 8 pre-dose, Week 8 post dose, Week 24 pre-dose and Week 24 post-dose. All participants who received albiglutide were initiated on a 30mg weekly dosing regimen; however, beginning at Week 12, participants in the albiglutide 50 mg treatment group were uptitrated to receive albiglutide 50 mg for the remainder of the study.|Weeks 8 and 24|ITT population. Only those participants with a PK sample available for analysis at the indicated time points were analyzed.||nanograms/milliliter (ng/mL)||Standard Deviation|Mean
787381|NCT00850174|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Oxcarbazepine|Bioequivalence based on AUC0-inf|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis. AUC0-inf was not able to be estimated from all data sets.||ng*h/mL||Standard Deviation|Mean
787208|NCT00849017|Secondary|Change From Baseline in Postprandial Blood Glucose Profile Parameters-4 Hour Insulin AUC and 4 Hour Proinsulin AUC|Changes from Baseline at Week 52 in postprandial parameters after a mixed-meal (MM) tolerance test were analyzed. Post prandial blood glucose parameters analyzed were: 4-hour insulin AUC (4 hr Ins AUC), and 4-hour proinsulin AUC (4 hr pro-Ins AUC). The AUC was determined using the trapezoidal method using measurements until 4 hours following the meal. The standardized AUC is the total AUC divided by elapsed time. Those parameters were analyzed analogous to the primary endpoint using an ANCOVA model with treatment group as a factor, and corresponding Baseline postprandial profile as a continuous covariate. This analysis used observed values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|Baseline and Week 52|MM Population: all participant who participated in the MM tolerance test substudy and who had valid baseline assessments and Week 52 assessments for at least 1 of the MM lab parameters of insulin, proinsulin. The MM tolerance test was performed only in those participants who additionally consented to participate in.||picomoles/Liter (pmol/L)||Standard Error|Least Squares Mean
787209|NCT00849017|Secondary|Change From Baseline in Postprandial Blood Glucose Profile Parameter- 4 Hour Blood Glucose AUC|Changes from Baseline at Week 52 in postprandial parameters after a mixed-meal (MM) tolerance test were analyzed. Post prandial blood glucose parameter analyzed was: 4 hour blood glucose area under urve AUC The AUC was determined using the trapezoidal method using measurements until 4 hours following the meal. The standardized AUC is the total AUC divided by elapsed time. Those parameters were analyzed analogous to the primary endpoint using an ANCOVA model with treatment group as a factor, and corresponding Baseline postprandial profile as a continuous covariate. This analysis used observed values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|Baseline and Week 52|MM Population: all participants who participated in the MM tolerance test substudy and who had valid baseline assessments and Week 52 assessments for at least 1 of the MM lab parameter of glucose. The MM tolerance test was performed only in those participants who additionally consented to participate in.||Nanomoles/Liter (nmol/L)||Standard Error|Least Squares Mean
787210|NCT00849017|Secondary|Change From Baseline in Postprandial Blood Glucose Profile Parameter-4 Hour C-peptide AUC|Changes from Baseline at Week 52 in postprandial parameters after a mixed-meal (MM) tolerance test were analyzed. Post prandial blood glucose parameter analyzed was 4 hour c-peptide AUC. The AUC was determined using the trapezoidal method using measurements until 4 hours following the meal. The standardized AUC is the total AUC divided by elapsed time. Those parameters were analyzed analogous to the primary endpoint using an ANCOVA model with treatment group as a factor, and corresponding Baseline postprandial profile as a continuous covariate. This analysis used observed values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|Baseline and Week 52|MM Population: all participants who participated in the MM tolerance test substudy and who had valid Baseline assessments and Week 52 assessments for at least 1 of the MM lab parameter of C-peptide.||Nanomoles/Liter (nmol/L)||Standard Error|Least Squares Mean
787211|NCT00849017|Secondary|Change From Baseline in Body Weight at Week 156|The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight.|Baseline and Week 156|ITT Population with observed values. Only those participants who were available at the indicated time points were analyzed. This analysis used observed body weight values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.||Kilograms||Standard Deviation|Mean
787212|NCT00849017|Secondary|Change From Baseline in Body Weight at Week 52|The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The LOCF method was used to impute missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue were treated as missing and replaced with prerescue values. Based on ANCOVA: change = treatment + Baseline weight + prior myocardial infarction history + age category + region + current antidiabetic therapy.|Baseline and Week 52|ITT Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 52.||Kilograms||Standard Error|Least Squares Mean
787213|NCT00849017|Secondary|Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156|The number of participants who acheieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <7%, and <7.5% at Week 156) were assessed.|Week 156|ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed. This analysis used observed HbA1c values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.||Participants|||Number
787214|NCT00849017|Secondary|Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 52|The number of participants who acheieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <7%, and <7.5% at Week 52) were assessed.|Week 52|ITT Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 52.||Participants|||Number
787215|NCT00849017|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 156|The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline FPG minus the Baseline FPG.|Baseline and Week 156|ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed. This analysis used observed FPG values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.||Millimoles per liter (mmol/L)||Standard Deviation|Mean
787216|NCT00849017|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52|The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. The LOCF method was used to impute missing post-Baseline FPG values. FPG values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on ANCOVA: change = treatment + Baseline weight + prior myocardial infarction history + age category + region + current antidiabetic therapy.|Baseline and Week 52|Intent-to-Treat (ITT) Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 52.||Millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
787217|NCT00849017|Secondary|Time to Hyperglycemia Rescue|Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue. The conditions for hyperglycemia rescue were as follows: FPG >=280 milligrams/deciliter (mg/dL) between >=Week 2 and <Week 4; FPG >=250 mg/dL between >=Week 4 and <Week 12; HbA1c >=8.5% and a <=0.5% reduction from Baseline between >=Week 12 and <Week 24; HbA1c >=8.5% between >=Week 24 and <Week 48; HbA1c >=8.0% between >= Week 48 and <Week 156. Participants could have been rescued at any time on or after Week 2. Time to hyperglycemia rescue is defined as the time between the date of the first dose of study medication and the date of hyperglycemia rescue plus 1 day, or the time between the date of the first dose of study medication and the date of the last visit during the active treatment period plus 1 day for participants not requiring rescue. This time was divided by 7 to express the result in weeks.|From the start of study medication until the end of the treatment (up to Week 156)|IIT Population. Only those participants with a value at Baseline and at the specified visit were analyzed.||Weeks||95% Confidence Interval|Median
787218|NCT00849017|Secondary|Change From Baseline in HbA1c at Weeks 104 and 156|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed HbA1c values, excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|Baseline and Weeks 104 and 156|ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Percentage of HbA1c in the blood||Standard Deviation|Mean
787219|NCT00849017|Primary|Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52|Glycated hemoglobin (HbA1c) is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The BL HbA1c is defined as the last non-missing value before the start of treatment. Change from BL was calculated as the value at Week 52 minus the value at BL. The analysis was performed using an Analysis of Covariance (ANCOVA) model with treatment group, region, history of prior myocardial infarction (yes versus no), and age category (<65 years versus ≥65 years) as factors and Baseline HbA1c as a continuous covariate. The last observation carried forward (LOCF) method was used to impute missing post-BL HbA1c values; the last non-missing post-BL on-treatment measurement was used to impute the missing measurement. HbA1c values obtained after hyperglycemic rescue were treated as missing and were replaced with pre-rescue values.|Baseline and Week 52|Intent-to-Treat (ITT) Population with LOCF: all randomized par. who received >=1 dose of study medication and who had a BL assessment and >=1 post-BL assessment of HbA1c. Only par. with a value at BL and at the specified visit were analyzed. Values were carried forward for par. who were rescued or discontinued from active treatment before Week 52.||Percentage of HbA1c in the blood||Standard Error|Least Squares Mean
787220|NCT00849056|Secondary|Change From Baseline in Body Weight at Week 156|The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight.|Baseline and Week 156|ITT Population with observed values. Only those participants who were available at the indicated time points were analyzed. This analysis used observed body weight values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.||Kilograms||Standard Deviation|Mean
787221|NCT00849056|Secondary|Change From Baseline in Body Weight at Week 52|The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The LOCF method was used to impute missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue were treated as missing and replaced with prerescue values. Based on ANCOVA: change = treatment + Baseline weight + prior myocardial infarction history + age category + region + current antidiabetic therapy.|Baseline and Week 52|ITT Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 52.||Kilograms||Standard Error|Least Squares Mean
787222|NCT00849056|Secondary|Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156|The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <6.5%, and <7.0% at Week 156) were assessed.|Week 156|ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed. This analysis used observed HbA1c values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.||Participants|||Number
787223|NCT00849056|Secondary|Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 52|The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <6.5%, and <7.0% at Week 52) were assessed.|Week 52|ITT Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 52.||Participants|||Number
787224|NCT00849056|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 156|The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline FPG minus the Baseline FPG.|Baseline and Week 156|ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed. This analysis used observed FPG values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.||Millimoles per liter (mmol/L)||Standard Deviation|Mean
787234|NCT00849121|Secondary|The Number of Participants Who Experience at Least a Two-fold Increase in the PSA Doubling Time During the Treatment Period.|The number of subjects who experience at least a two-fold increase in the PSA doubling time will be documented for each study arm. The PSA doubling time will be calculated using all PSA values obtained starting on Treatment Day 0 and continuing to end of treatment period and compared to the PSA doubling time collected at study entry prior to beginning study treatment.|Starting at Treatment Day 0 and continuing every 4-6 weeks until end of treatment period, an average of 2 years|||participants|||Number
787382|NCT00850174|Primary|Cmax - Maximum Observed Concentration - Oxcarbazepine in Plasma|Bioequivalence based on Cmax|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
787225|NCT00849056|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52|The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. The LOCF method was used to impute missing post-Baseline FPG values. FPG values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on ANCOVA: change = treatment + Baseline weight + prior myocardial infarction history + age category + region + current antidiabetic therapy.|Baseline and Week 52|Intent-to-Treat (ITT) Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 52.||Millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
787226|NCT00849056|Secondary|Time to Hyperglycemia Rescue|Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue. The conditions for hyperglycemia rescue were as follows: FPG >=280 milligrams/deciliter (mg/dL) between >=Week 2 and <Week 4; FPG >=250 mg/dL between >=Week 4 and <Week 12; HbA1c >=8.5% and a <=0.5% reduction from Baseline between >=Week 12 and <Week 24; HbA1c >=8.5% between >=Week 24 and <Week 48; HbA1c >=8.0% between >= Week 48 and <Week 156. Participants could have been rescued at any time on or after Week 2. Time to hyperglycemia rescue is defined as the time between the date of the first dose of study medication and the date of hyperglycemia rescue plus 1 day, or the time between the date of the first dose of study medication and the date of the last visit during the active treatment period plus 1 day for participants not requiring rescue. This time was divided by 7 to express the result in weeks.|From the start of study medication until the end of the treatment (up to Week 156)|ITT Population. Only those participants with a value at Baseline and at the specified visit were analyzed.||Weeks||95% Confidence Interval|Median
787227|NCT00849056|Primary|Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The BL HbA1c value is defined as the last non-missing value before the start of treatment. Change from BL was calculated as the value at Week 52 minus the value at BL. Based on analysis of covariance (ANCOVA): change = treatment + BL HbA1c + prior myocardial infarction history + age category + region + current antidiabetic therapy. The last observation carried forward (LOCF) method was used to impute missing post-BL HbA1c values; the last non-missing post-BL on-treatment measurement was used to impute the missing measurement. HbA1c values obtained after hyperglycemic rescue were treated as missing and were replaced with pre-rescue values. One Intent-to-Treat (ITT) participant (par.) had all post-BL HbA1c measurements occur after hyperglycemic rescue. This par. is included in the ITT Population counts but did not contribute to this analysis.|Baseline and Week 52|Intent-to-Treat (ITT) Population with LOCF: all randomized par. who received >=1 dose of study medication and who had a BL assessment and >=1 post-BL assessment of HbA1c. Only par. with a value at BL and at the specified visit were analyzed. Values were carried forward for par. who were rescued or discontinued from active treatment before Week 52.||Percentage of HbA1c in the blood||Standard Error|Least Squares Mean
787228|NCT00849056|Secondary|Change From Baseline in HbA1c at Weeks 104 and 156|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed HbA1c values, excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|Baseline and Weeks 104 and 156|ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed (represented by n=X, X in the category titles).||Percentage of HbA1c in the blood||Standard Deviation|Mean
787229|NCT00849108|Primary|Cohort 2: Diagnostic Efficacy of One-day Rest/Stress BMS747158 PET MPI Specificity (SP) vs SPECT MPI Specificity|Diagnostic efficacy of one-day rest/stress BMS747158 PET MPI is measured by specificity as compared to single photon emission computed tomography (SPECT)MPI in the detection of coronary artery disease (CAD)using angiography or three-month cardiac events as the truth standard.|Dosing Visit|intent to treat, received at least one dose of BMS747158||Proportion of True Negative Cases|||Number
787230|NCT00849108|Primary|Cohort 1: Determination of Ratio of Stress Dose to Rest Dose|The stress flurpiridaz dose for subsequent same-day rest-stress efficacy studies was determined as a multiple of the rest dose by computer modeling. Images derived only from rest flurpiridaz administration were blended using image analysis with images derived only from administration of flurpiridaz following exercise or adenosine stress. The blending fraction that resulted in negligible change in reader interpretation of defect severity was determined for each subject. The minimum value that met this criterion for all subjects was used to calculate the ratio of the stress dose to the rest dose as a function of the delay between administration of the two doses for both adenosine stress and exercise stress separately. No statistical analysis was performed.|Dosing visit|Subjects with demonstrated partially or completely reversible defects on prior SPECT who received at least one stress and one rest dose of flurpiridaz F 18, on separate days.||Fraction of rest added to stress image|||Number
787231|NCT00849108|Primary|Cohort 2: Diagnostic Efficacy of One-day Rest/Stress BMS747158 PET MPI Sensitivity (SN) vs SPECT MPI Sensitivity|Diagnostic efficacy of one-day rest/stress BMS747158 PET MPI is measured by sensitivity as compared to single photon emission computed tomography (SPECT)MPI in the detection of coronary artery disease (CAD)using angiography or three-month cardiac events as the truth standard.|Dosing visit|intent to treat, received at least one dose of BMS747158||Proportion of True Positive Cases|||Number
787232|NCT00849108|Primary|Cohort 1: Determination of Rest Dose: Dose Acquistion Time Product|The rest flurpiridaz dose to be used for subsequent efficacy studies was determined by a modeling method that simulated a range of injected doses using a single fixed injected dose at rest in each subject and a range of acquisition durations. From this, a dose acquisition time product (DATP was determined for each subject that specified the minimal dose for a given acquisition duration that yielded an image in that subject that was negligibly affected by photon counting statistics. Descriptive statistics were used to identify an appropriate rest dose for the population. No other statistical tests were performed|Dosing visit|Intent to treat, received at least one rest dose of BMS 747158||MBq X Minutes||Standard Deviation|Mean
787383|NCT00850200|Secondary|Assess Disease Control and Survival Outcomes||During radiation therapy; then after radiation, every 3 months for the first year, then every 6 months for the next 4 years, then annually||||||
787235|NCT00849121|Primary|Number of Participants Who Experience at Least a 3-fold Higher PAP-specific T-cell Frequency or Proliferation Index at One Year Compared to Baseline.|The number of patients with a T-cell immune response will be determined for each study arm. An immune response will be defined as a PAP-specific T-cell frequency or proliferation index at 1 year that is at least 3-fold higher than the baseline T-cell frequency or proliferation index.|Baseline and 1 year.|||participants|||Number
787236|NCT00849121|Primary|Number of Participants With > = Grade 2 Autoimmune Events or >=Toxicities at Least Possibly Related to pTVG-HP With GM-CSF Study Treatment.|The number and severity of toxicity incidents occurring between the pre-treatment and the final off-study evaluation will be collected and assigned an attribution. The toxicities observed will be summarized in terms of types and severities by the NCI Common Terminology Criteria version 3 for each study arm. The number of subjects experiencing grade 2 or higher autoimmune events or grade 3 or higher toxicities felt to be at least possibly related to pTVG-HP with GM-CSF study treatment will be compared between the two arms.|From the time the patient begins treatment until 30 days after the last treatment with pTVG-HP vaccine, up to a maximum of 2 years|||participants|||Number
787237|NCT00849147|Secondary|Infections|Number of infections; infections will be reported by anatomic site, date of onset, organism and resolution, if any. Patients will be followed for infection for 1 year post-transplant.|Measured at Year 1|36 patients incurred a total number of 108 infection events.||participants|||Number
787238|NCT00849147|Secondary|Treatment-related Mortality (TRM)||Measured at 6 months and 1 year|||percentage of participants||95% Confidence Interval|Number
787239|NCT00849147|Secondary|Progression-free Survival|Progression-free survival is defined as the minimum time interval of the times to relapse/recurrence, to death or to last follow-up.|Measured at Year 1|||percentage of participants||95% Confidence Interval|Number
787240|NCT00849147|Secondary|Chronic GVHD||Measured at Year 1|||percentage of participants||95% Confidence Interval|Number
787241|NCT00849147|Secondary|Acute Graft-versus-host Disease (GVHD)||Measured at Day 100|||percentage of participants||95% Confidence Interval|Number
787242|NCT00849147|Secondary|Donor Cell Engraftment|Marrow or Blood Sample. Donor cell engraftment is defined as donor chimerism ≥ 5% on Day ≥ 56 after transplantation. Chimerism should be evaluated on Days ~28, ~56, ~180, and ~365 after transplantation. Chimerism may be evaluated in whole blood or mononuclear fraction.|Measured at Day 56|||participants|||Number
787243|NCT00849147|Secondary|Platelet Recovery|Platelet Recovery to 50K|Measured at Days 56, 90, and 100|||percentage of participants||95% Confidence Interval|Number
787244|NCT00849147|Secondary|Platelet Recovery|Platelet Recovery to 20K|Measured at Days 56, 90, and 100|||percentage of participants||95% Confidence Interval|Number
787245|NCT00849147|Secondary|Secondary Graft Failure|Secondary graft failure is defined as initial recovery followed by neutropenia with < 5% donor chimerism. If no chimerism assays were performed and absolute neutrophil count is < 500/mm3, then it will be counted as a secondary graft failure.|Measured at Day 100|||participants|||Number
787246|NCT00849147|Secondary|Primary Graft Failure|Primary graft failure is defined as < 5% donor chimerism on all measurements.|Measured at Day 67|||participants|||Number
787247|NCT00849147|Secondary|Neutrophil Recovery|Cumulative incidence of neutrophil recovery >500/μL at day +56|Measured at Days 28, 56, 90, and 100|||percentage of participants||95% Confidence Interval|Number
787248|NCT00849147|Primary|Overall Survival at 180 Days From the Time of Transplant||Measured at Month 6 and Year 1|||percentage of participants||95% Confidence Interval|Number
787249|NCT00849186|Secondary|Response Rate After 90 Days of Treatment With SM||90 days|All treated and eligible patients||proportion of participants||95% Confidence Interval|Number
787250|NCT00849186|Primary|Safety of Surgery After 90 Days of Treatment With SM|Incident Rate: Intraoperative Complication Rate|90 days|All treated and eligible patients||proportion of participants||95% Confidence Interval|Number
787251|NCT00849186|Primary|Safety of Sunitinib Malate (SM)|Incident Rate: The proportion of the population who experience a grade 3 or higher endpoint-relevant toxic event within 3 months of the beginning of treatment.|90 days|All treated and eligible patients||proportion of participants||95% Confidence Interval|Number
787252|NCT00849212|Secondary|Percent Change in Total Seizure Frequency Per 28 Days From Baseline (Maintenance Period) ; LOCF|The percent change in seizure frequency per 28 days during the maintenance period was collected via patient diary cards. This was calculated using the last observation carried forward (LOCF) method.|Baseline (Day -28 to Day 0), Week 1 to Week 10|"Efficacy analysis set:
Population after excluding : (a) Patients who do not meet the inclusion criteria, (b) Patients who meet the exclusion criteria which affect efficacy evaluation of E2007, (c) Patients untreated,(d) Patients with no evaluable data on efficacy,(e) Patients with <80% treatment compliance"||Percent change||Full Range|Median
787253|NCT00849212|Primary|Maximum Tolerated Dose (MTD)|MTD was defined by participants. For participants who completed treatment, MTD was dose at last administration. For subjects who discontinued due to adverse event (AE), the MTD depended on the number of days within down-titration. If these criteria were not applied, the MTD was determined based on suggestions from the Tolerability and Safety Evaluation Committee.|10 weeks (Titration and Maintenance Periods)|Safety analysis set||Participants|||Number
787254|NCT00849251|Primary|Maximum Tolerated Dose of This Combination of Drugs as Assessed by the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (Cohort 1). [Dexamethasone MTD]|If 3 patients of cohort 1 require dose reduction of one or more of the medications for toxicity attributed to the drug or drugs, then the starting dose level will be reduced for that drug or drugs for future patients. The initial dosing of drugs for cohort 2 will be permitted to be one dose level above the maximal tolerated doses of cohort 1. Note that this Outcome Measure will only describe the MTD for dexamethasone. Dexamethasone could not be reported with the MTD for the other three drugs due to a different Unit of Measure.|Up to 90 days after initiation of study treatment|Patients with relapsed multiple myeloma who received cyclophosphomide, bortezomib, liposomal doxorubicin and dexamethasone. Note that this Outcome Measure will only describe the MTD for dexamethasone. Dexamethasone could not be reported with the MTD for the other three drugs due to a different Unit of Measure.||mg|||Number
787255|NCT00849251|Primary|Disease Response Rate (Cohort II)|Disease response using Blade Multiple Myeloma Response Criteria in newly diagnosed (Cohort II) patients who completed at least one cycle of treatment. There were 24 evaluable patients in Cohort II.|up to 28 days after last cycle of treatment|Newly diagnosed patients (cohort II)||Participants|||Count of Participants
787256|NCT00849251|Primary|Maximum Tolerated Dose of This Combination of Drugs as Assessed by the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (Cohort 1) [MTD Cyclophosphamide, MTD Bortezmib, MTD Docxorubicin]|If 3 patients of cohort 1 require dose reduction of one or more of the medications for toxicity attributed to the drug or drugs, then the starting dose level will be reduced for that drug or drugs for future patients. The initial dosing of drugs for cohort 2 will be permitted to be one dose level above the maximal tolerated doses of cohort 1. Note that this Outcome Measure shows MTD for cyclophosphamide, bortezomib and doxorubicin. MTD for dexamethasone is include in a separate table due to the different Unit of Measure.|Up to 90 days after initiation of study treatment|Patients with relapsed multiple myeloma who received cyclophosphomide, bortezomib, liposomal doxorubicin and dexamethasone. Note that the MTD for dexamethasone is in a separate table due to the different dosing unit.||mg/m2|||Number
787257|NCT00849290|Secondary|To Evaluate the Efficacy of APC8015F in Delaying Prostate Specific Antigen Doubling Time and on Overall Clinical Response||periodically over 24 months||||||
787258|NCT00849290|Primary|Safety of APC8015F by Review of Reported Adverse Events|All subjects who received at least one infusion of APC8015F (N = 109) were included in the safety analysis set and were followed for safety. Refer to Serious Adverse Events and Other Adverse Events.|periodically over 24 months|All participants who received at least one infusion of APC8015F||participants|||Number
787259|NCT00849381|Primary|Number of Subjects With Pregnancies and Pregnancy Outcomes|The pregnancy outcomes reported included elective termination, live birth and spontaneous abortion, all of which occurred with no apparent congenital (congenit.) anomalies (anom.) Note: Results from one non-compliant center (NCC) are also presented separately.|During the entire study period (up to Month 12)|The analysis was based on the subjects with positive pregnancy results in the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of Cervarix vaccine in this study and for whom data were available.||Subjects|||Number
787260|NCT00849381|Primary|Number of Subjects With Any, Grade 3 and Related Medically Significant Conditions (MSCs)|MSCs include adverse events prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|During the entire study period (up to Month 12)|||Subjects|||Number
787261|NCT00849381|Primary|Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)|"SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Note: Results from one center where compliance issues were discovered are presented also separately."|During the entire study period (up to Month 12)|||Subjects|||Number
787262|NCT00849472|Secondary|Number of Participants With Recurrence Events|The number of participants with recurrence events during the 24 months after study entry are reported. A recurrence event is defined as invasive local (evidence of invasive/in situ breast cancer [except LCIS] in the ipsilateral breast [IB]/skin of the breast), regional (development of tumor in the ipsilateral [IP] internal mammary, IP supraclavicular, IP infraclavicular, and/or IP axillary nodes, as well as the soft tissue of the IP axilla, following surgery), or distant (evidence of tumor in all areas, with the exception of those described for local and regional recurrence) breast cancer recurrence during the 24 months after study entry.|up to 24 months after study entry|Evaulable Population, excluding participants with recurrence before study entry||participants|||Number
787263|NCT00849472|Secondary|Number of Participants With the Indicated Radiotherapy-related Complications||up to 24 months after study entry|Treated Population||participants|||Number
787264|NCT00849472|Secondary|Participants With Normal Thyroid Stimulating Hormone (TSH) Levels at Baseline Who Had an Elevated TSH Level at Least Once During the Study and During the Individual Study Periods|The number of participants with normal thyroid function at Baseline who had an elevation in TSH during the study were recorded. TSH elevation was derived based on local laboratory ranges.|up to 24 months after study entry|Treated Population. Data are presented for only those participants who remained in the study during the indicated period and had their blood drawn for assessment.||participants|||Number
787265|NCT00849472|Secondary|Number of Participants With Cardiac Toxicity (Per CTCAE Version 3.0) During the Postoperative Pazopanib Period|The number of participants with cardiac toxicity was defined as those who had cardiac events of Grades (G) 3 and 4 leftventricular dysfunction (LVD) (CTCAE Version 3.0) and/or who had definite or probable cardiac death. Grade refers to the severity of the AE: G 1, mild AE; G 2, moderate AE; G 3, severe AE; G 4, life-threatening/disabling AE; G 5, death related to the AE. A G3 LVD event is defined as symptomatic congestive heart failure (CHF) responsive to intervention. A G4 event is defined as poorly controlled refractory CHF; ventricular assist device or heart transplant indicated.|From the start of the study until the end of the postoperative pazopanib period, which coincides with the start of the end of treatment period (an average of 310.8 days [standard deviation of 85.29 days] after study entry)|Treated Population: Only those members of the Treated Population who started the postoperative pazopanib period were assessed.||Participants|||Number
787266|NCT00849472|Secondary|Number of Participants With Cardiac Toxicity (Per CTCAE Version 3) at the Completion of the AC and Weekly Paclitaxel (WP) + Pazopanib Preoperative Periods|The number of participants with cardiac toxicity was defined as those who had cardiac events of Grades (G) 3 and 4 leftventricular dysfunction (LVD) (CTCAE Version 3.0) and/or who had definite or probable cardiac death. Grade refers to the severity of the AE: G 1, mild AE; G 2, moderate AE; G 3, severe AE; G 4, life-threatening/disabling AE; G 5, death related to the AE. A G3 LVD event is defined as symptomatic congestive heart failure (CHF) responsive to intervention. A G4 event is defined as poorly controlled refractory CHF; ventricular assist device or heart transplant indicated.|From the start of the study until the preoperative evaluation (an average of 203.0 days [standard deviation of 23.19 days] after study entry).|Treated Population||Participants|||Number
787290|NCT00849693|Secondary|Change From Baseline in Clinical Global Impressions of Severity (CGI-Severity) Scale at Week 10 Endpoint|CGI-Severity evaluates the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). LS means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment*visit, age category*visit and baseline*visit.|Baseline, Week 10|Participants with both a baseline and at least one post-baseline value.||units on a scale||Standard Error|Least Squares Mean
787267|NCT00849472|Secondary|Number of Participants With Cardiac Toxicity (Per Common Terminology Criteria for Adverse Events Version 3) at the Completion of the AC Period|The number of participants with cardiac toxicity was defined as those who had cardiac events of Grades (G) 3 and 4 leftventricular dysfunction (LVD) (CTCAE Version 3.0) and/or who had definite or probable cardiac death. Grade refers to the severity of the AE: G 1, mild AE; G 2, moderate AE; G 3, severe AE; G 4, life-threatening/disabling AE; G 5, death related to the AE. A G3 LVD event is defined as symptomatic congestive heart failure (CHF) responsive to intervention. A G4 event is defined as poorly controlled refractory CHF; ventricular assist device or heart transplant indicated.|From the start of the study until the preoperative evaluation (an average of 86.2 days [standard deviation of 5.76 days] after study entry)|Treated Population: all participants who entered the study and received at least one dose of any study medication||Participants|||Number
787268|NCT00849472|Secondary|Invasive Recurrence-free Interval (IRFI)|IRFI was assessed as the time from study entry until the diagnosis of the first invasive local (evidence of invasive/in situ breast cancer [except LCIS] in the ipsilateral breast [IB]/skin of the breast), regional (development of tumor in the ipsilateral [IP] internal mammary, IP supraclavicular, IP infraclavicular, and/or IP axillary nodes, as well as the soft tissue of the IP axilla, following surgery), or distant (evidence of tumor in all areas, with the exception of those described for local and regional recurrence) breast cancer recurrence during the 24 months after study entry.|up to 24 months after study entry|Evaulable Population. Participants with recurrence before study entry were excluded from analysis.||months||95% Confidence Interval|Median
787269|NCT00849472|Secondary|Number of Participants With Clinical CR (cCR) in the Breast and Nodes at the Completion of the AC and Weekly Paclitaxel (WP) + Pazopanib Preoperative Periods|cCR was determined by tumor assessments performed by palpation. All clinical response assessments were to be performed by physical examination of the breast and the axilla. cCR was defined as the resolution of all target and non-target lesions identified at Baseline and no new lesions or other signs of disease progression. The criteria to be used for the determination of progressive disease were at the investigator's discretion.|From the start of the study until the preoperative evaluation (an average of 203.0 days [standard deviation of 23.19 days] after study entry)|Evaluable Population||Participants|||Number
787270|NCT00849472|Secondary|Number of Participants With Clinical Complete Response (cCR) in the Breast and Nodes at the Completion of the Doxorubicin and Cyclophosphamide (AC) Period|cCR was determined by tumor assessments performed by palpation. All clinical response assessments were to be performed by physical examination of the breast and the axilla. cCR was defined as the resolution of all target and non-target lesions identified at Baseline and no new lesions or other signs of disease progression. The criteria to be used for the determination of progressive disease were at the investigator's discretion.|From the start of the study until an average of 86.2 days (standard deviation of 5.76 days) after study entry|Evaluable Population||Participants|||Number
787271|NCT00849472|Secondary|Number of Participants With Pathologic Complete Response (pCR) in the Breast|pCR was defined as no histologic evidence of invasive tumor cells in the surgical breast specimen.|From the start of the study until the time of surgery (average of 221.9 [standard deviation of 23.65 days] days after study entry)|Evaluable Population||Participants|||Number
787272|NCT00849472|Primary|Number of Participants With Pathologic Complete Response (pCR) in the Breast and Nodes|pCR was defined as no histologic evidence of invasive tumor cells in the surgical breast specimen, axillary nodes, or sentinel node identified after neoadjuvant chemotherapy.|From the start of the study until the time of surgery (average of 221.9 days [standard deviation of 23.65 days] after study entry)|Evaluable Population: all participants who entered the study and received at least one dose of pazopanib.||Participants|||Number
787273|NCT00849485|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||mcg*h/mL||Standard Deviation|Mean
787274|NCT00849485|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||mcg*h/mL||Standard Deviation|Mean
787275|NCT00849485|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||mcg/mL||Standard Deviation|Mean
787276|NCT00849524|Secondary|Determine Pharmacodynamic Parameters in Patients Treated With Repeat Intranodal Injections of Ad-ISF35.||2 years (evaluation will be approx. 4 months per patient)|The study was not completed due to unavailability of the study drug, and therefore data were not collected for this Outcome Measure.|||||
787277|NCT00849524|Secondary|Determine the Safety of Repeat Administration of Ad-ISF35 Injected Directly Into Lymph Nodes of Patients With CLL/SLL.||2 years (evaluation will be approx. 1 year per patient)|The study was not completed due to unavailability of the study drug, and therefore data were not collected for this Outcome Measure.|||||
787278|NCT00849524|Primary|Determine and Monitor Clinical and Biological Responses in Patients Treated With Repeat Intranodal Injections of Ad-ISF35.||2 years (evaluation will be approx. 4 months per patient)|The study was not completed due to unavailability of the study drug, and therefore data were not collected for this Outcome Measure.|||||
787279|NCT00849680|Primary|Immune Response by Levels of Unfractionated Gag, Pol, and Nef-specific IFN-gamma Following a 2-dose Vaccine Regimen|"Participants expressing HIV antigens (gag, pol and nef) secrete antigen specific interferon-gamma (IFN-gamma). Levels of unfractionated gag, pol, and nef-specific IFN-gamma were to be measured using an Enzyme Linked Immunospot Assay (ELISPOT), which measures spot forming cells per 10^6 peripheral blood mononuclear cells (SFC per million PBMCs).
No immunogenicity analyses were performed because the results from a previous study, V520-023 (NCT00095576), which used the same vaccine as the one used in this study (NCT00849680) proved it was not efficacious."|4 weeks after booster injection|No immunogenicity analyses were performed because the results from a previous study, V520-023 (NCT00095576), which used the same vaccine as the one used in this study (NCT00849680) proved it was not efficacious.|||||
787384|NCT00850200|Secondary|Assess Improvement and Other Dosimetric Endpoints||Prior to starting radiation therapy||||||
787449|NCT00844194|Secondary|Suicidal Thoughts or Behaviours by HAMD-17 at Week 12||Week 12|All patients receiving at least one dose of study medication and having data at week 12.||Participants|||Number
787280|NCT00849680|Primary|Immune Response by Levels of Unfractionated Gag, Pol, and Nef-specific IFN-gamma Following a 3-dose Vaccine Regimen|Participants expressing HIV antigens (gag, pol and nef) secrete antigen specific interferon-gamma (IFN-gamma). Levels of unfractionated gag, pol, and nef-specific IFN-gamma were to be measured using an Enzyme Linked Immunospot Assay (ELISPOT), which measures spot forming cells per 10^6 peripheral blood mononuclear cells (SFC per million PBMCs).|4 weeks after booster injection|No immunogenicity analyses were performed because the results from a previous study, V520-023 (NCT00095576), which used the same vaccine as the one used in this study (NCT00849680) proved it was not efficacious.|||||
787281|NCT00849680|Primary|Number of Participants With Laboratory Adverse Experiences|"Laboratory AEs were based on a grading system considering the severity of abnormal laboratory values in participants and reflect any unfavorable and unintentional change in function, or chemistry of the body.
All laboratory AEs were collected up to 29 days after any vaccine dose."|up to 260 weeks after first vaccination|Participants administered at least one dose of study vaccine. One participant who was lost to follow-up, and another one participant who discontinued as he comply with the protocol are not included.||Participants|||Number
787282|NCT00849680|Primary|Number of Participants With Adverse Experiences|"Adverse experiences (AE) collected include serious and non serious systemic AEs, and injection-site AEs.
Systemic and Laboratory AEs include any unfavorable & unintended change in the structure, function, or chemistry of the body.
Injection-site AEs include any swelling, redness, pain or tenderness at the injection site. All injection site AEs were collected up to 5 days after any vaccine dose."|up to 260 weeks after first vaccination|||Participants|||Number
787283|NCT00849693|Secondary|Percentage of Participants With Potentially Clinically Significant (PCS) Changes in Systolic Blood Pressure (BP), Diastolic BP, Pulse, and Weight Any Time Week 10 Through Week 36|PCS increase in systolic and diastolic BP was defined as increase of ≥5 mm Hg from baseline (BL) high value to a value above the 95th percentile at post-BL; PCS increase of pulse was defined as >140 and increase of ≥15 from BL high value for age 7-11 and >120 and increase of ≥15 from BL high value for age 12-17; PCS decrease of pulse was defined as <60 and a decrease of ≥25 from BL low value for age 7-11 and <50 and a decrease of ≥15 from BL low value for age 12-17; PCS decrease of weight was defined as decrease of at least 3.5% from BL low value.|Week 10 through Week 36|Participates with normal value before week 10 and at least one non-missing post-Week 10 value, and who are at risk for the specific PCS criteria.||percentage of participants|||Number
787284|NCT00849693|Secondary|Percentage of Participants With Potentially Clinically Significant (PCS) Changes in Systolic Blood Pressure (BP), Diastolic BP, Pulse, and Weight Any Time Baseline Through Week 10|PCS increase in systolic and diastolic BP was defined as increase of ≥5 millimeter mercury (mm Hg) from baseline (BL) high value to a value above the 95th percentile at post-BL; PCS increase of pulse was defined as >140 and increase of ≥15 from BL high value for age 7-11 and >120 and increase of ≥15 from BL high value for age 12-17; PCS decrease of pulse was defined as <60 and a decrease of ≥25 from BL low value for age 7-11 and <50 and a decrease of ≥15 from BL low value for age 12-17; PCS decrease of weight was defined as decrease of at least 3.5% from BL low value.|Baseline through Week 10|Participants with normal baseline value and at least one post-baseline value, and who were at risk for the specific PCS criteria.||percentage of participants|||Number
787285|NCT00849693|Secondary|Number of Participants With Potentially Clinically Significant Hepatic Laboratory Results Any Time Week 10 Through Week 36|Total number of participants with any abnormal post-baseline value, based on all values at scheduled and unscheduled visits. Potentially clinically significant hepatic laboratory results at any time are defined as ALT ≥3 x ULN, ALT ≥5 x ULN and ALT ≥10 x ULN, as well as ALT≥3 x ULN and Total Bilirubin ≥2 x ULN.|Week 10 through Week 36|Participants with normal ALT value (ALT<1 x ULN) at last non-missing visit before Week 10 and at least one non-missing post-Week 10 value.||participants|||Number
787286|NCT00849693|Secondary|Number of Participants With Potentially Clinically Significant Hepatic Laboratory Results Any Time Baseline Through Week 10|Total number of participants with any abnormal post-baseline value, based on all values at scheduled and unscheduled visits. Potentially clinically significant hepatic laboratory results at any time are defined as alanine transaminase (ALT) ≥3 x upper limit of normal (ULN), ALT ≥5 x ULN and ALT ≥10 x ULN, as well as ALT ≥3 x ULN and Total Bilirubin ≥2 x ULN.|Baseline through Week 10|Participants with normal ALT value (ALT<1 x ULN) at last non-missing baseline visit and at least one non-missing post-baseline value.||participants|||Number
787287|NCT00849693|Secondary|Number of Participants With Suicidal Ideation or Suicidal Behavior Week 10 Through Week 36|"Columbia Suicide Rating Scale (C-SSRS) captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior: a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a yes answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Treatment Emergent Suicidal Ideation is worsening or new occurrence of events during treatment compared to lead-in baseline (Week 7-10)."|Week 10 through Week 36|Participants with a baseline and at least one post-baseline C-SSRS suicidal ideation or suicidal behavior score and who are at risk for treatment emergent suicidal ideation or behavior.||participants|||Number
787288|NCT00849693|Secondary|Number of Participants With Suicidal Ideation or Suicidal Behavior Baseline Through Week 10|"Columbia Suicide Rating Scale (C-SSRS) captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior: a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a yes answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Treatment Emergent Suicidal Ideation is worsening or new occurrence of events during treatment compared to lead-in baseline (Week -1 to 0)."|Baseline through Week 10|Participants with a baseline and at least one post-baseline C-SSRS suicidal ideation or suicidal behavior score and who are at risk for treatment emergent suicidal ideation or behavior.||participants|||Number
787289|NCT00849693|Secondary|Change From Week 10 in Clinical Global Impressions of Severity (CGI-Severity) Scale at Week 36 Endpoint|CGI-Severity evaluates the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). LS means are adjusted for baseline, pooled investigator, age category, visit, age category*visit and baseline*visit.|Week 10, Week 36|Participants with value during treatment phase and at least one post-Week 10 value.||units on a scale||Standard Error|Least Squares Mean
787291|NCT00849693|Secondary|Change From Week 10 in Children's Depression Rating Scale-Revised (CDRS-R) Subscale Score at Week 36 Endpoint|CDRS-R Subscale scores include Mood (Sum of items 8, 11, 14, 15), Somatic (Sum of items 4-7, 16, 17), Subjective (Sum of items 9, 10, 12, 13) and Behavior (Sum of items 1-3). Mood and Subjective subscale scores range from 4 to 28; Somatic subscale scores range from 6 to 36; Behavior subscale scores range from 3 to 21. Higher score indicates greater severity of disease. LS means are adjusted for baseline, pooled investigator, age category, visit, age category*visit and baseline*visit.|Week 10, Week 36|Participants with value during treatment phase and at least one post-Week 10 value.||units on a scale||Standard Error|Least Squares Mean
787292|NCT00849693|Secondary|Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Subscale Score at Week 10 Endpoint|CDRS-R Subscale scores include Mood (Sum of items 8, 11, 14, 15), Somatic (Sum of items 4-7, 16, 17), Subjective (Sum of items 9, 10, 12, 13) and Behavior (Sum of items 1-3). Mood and Subjective subscale scores range from 4 to 28; Somatic subscale scores range from 6 to 36; Behavior subscale scores range from 3 to 21. Higher score indicates greater severity of disease. LS means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment*visit, age category*visit and baseline*visit.|Baseline, Week 10|Participants with both a baseline and at least one post-baseline values.||units on a scale||Standard Error|Least Squares Mean
787293|NCT00849693|Secondary|Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 10 Endpoint|CDRS-R Total score measure the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. Least Square (LS) means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment*visit, age category*visit and baseline*visit.|Baseline, Week 10|Participants with both a baseline and at least one post-baseline value.||units on a scale||Standard Error|Least Squares Mean
787294|NCT00849693|Secondary|Change From Week 10 in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 36 Endpoint|CDRS-R Total score measure the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. LS means are adjusted for baseline, pooled investigator, age category, visit, age category*visit and baseline*visit.|Week 10, Week 36|Participants with value during treatment phase and at least one post-Week 10 value.||units on a scale||Standard Error|Least Squares Mean
787295|NCT00849693|Primary|Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 10 Endpoint|CDRS-R Total score measure the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. Least Square (LS) means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment*visit, age category*visit and baseline*visit.|Baseline, Week 10|Participants with both a baseline and at least one post-baseline value.||units on a scale||Standard Error|Least Squares Mean
787296|NCT00849797|Secondary|AUC0-t - 10-Hydroxy-Carbazepine Metabolite|Informational Purposes Only|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
787297|NCT00849797|Secondary|AUC0-inf - 10-Hydroxy-Carbazepine Metabolite|Informational Purposes Only|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
787298|NCT00849797|Secondary|Cmax - 10-hydroxy-carbazepine in Plasma|Informational Purposes Only|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
787299|NCT00849797|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Oxcarbazepine|Bioequivalence based on AUC0-t|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
787300|NCT00849797|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Oxcarbazepine|Bioequivalence based on AUC0-inf|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
787301|NCT00849797|Primary|Cmax - Maximum Observed Concentration - Oxcarbazepine in Plasma|Bioequivalence based on Cmax|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
787302|NCT00849810|Primary|Primary Outcome is Pre- and Post-treatment Ambulatory Blood Pressure.||4 weeks (pre- and post-treatment)|||mm HG||Standard Deviation|Mean
787303|NCT00849862|Primary|AUC0-t - Area Under Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||mcg*h/mL||Standard Deviation|Mean
787304|NCT00849862|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||mcg*h/mL||Standard Deviation|Mean
787305|NCT00849862|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||mcg/mL||Standard Deviation|Mean
787327|NCT00849875|Secondary|Overall Survival (OS) by Gene Signature|OS was defined as the time from first treatment to the date of death. OS analysis was performed using the non-parametric Kaplan-Meier method. Each patient was censored out at the time of death.|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of the GSK2132231A product.||Months||95% Confidence Interval|Median
787450|NCT00844194|Secondary|Suicidal Thoughts or Behaviours by HAMD-17 at Week 6||Week 6|All patients receiving at least one dose of study medication and having data at week 6.||Participants|||Number
787306|NCT00849875|Secondary|Number of Patients With Any Serious Adverse Events (SAEs) and With AEs by Maximum Grade|SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a patient, is a Grade 4 AE according to the CTCAE, version3.0. Events which were part of the natural course of the disease under study were captured as part of the clinical activity outcome variables in this study; therefore did not need to be reported as SAEs. Progression/recurrence of the tumor was recorded as part of the clinical assessment data collection, and deaths due to progressive disease was recorded on a specific form, but not as an SAE. SAEs reported are here below tabulated irrespective of grade (any), as well as graded by maximum grade reported according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. Maximum grade reported and tabulated were Grade 1 (G1), G2, G3, G4 and G5.|Within the 31-day follow-up period post treatment administration.|The Total Treated population included all patients who have received at least one dose of GSK2132231A.||Subjects|||Number
787307|NCT00849875|Secondary|Number of Patients With Any Adverse Events (AEs) and With AEs by Maximum Grade|An AE was any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs reported are here below tabulated irrespective of grade (any), as well as graded by maximum grade reported according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. Maximum grade reported and tabulated were Grade 1 (G1), G2, G3, G4 and G5.|Within the 31-day follow-up period post treatment administration.|The Total Treated population included all patients who have received at least one dose of GSK2132231A.||Subjects|||Number
787308|NCT00849875|Secondary|Number of Patients With Abnormal Platelets(PLT) Values by Maximum Grade|The status of each patient as regards PLT laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0) and G1. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of GSK2132231A.||Subjects|||Number
787309|NCT00849875|Secondary|Number of Patients With Abnormal Partial Thromboplastin Time (PTT) Values by Maximum Grade|The status of each patient as regards PTT laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0) and G1. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of GSK2132231A.||Subjects|||Number
787310|NCT00849875|Secondary|Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade|The status of each patient as regards NEU laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0). CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of GSK2132231A.||Subjects|||Number
787311|NCT00849875|Secondary|Number of Patients With Abnormal Lymphopenia (LYM) Values by Maximum Grade|The status of each patient as regards LYM laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0) and G1. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of GSK2132231A.||Subjects|||Number
787312|NCT00849875|Secondary|Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade|The status of each patient as regards LEU laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0) and G1. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of GSK2132231A.||Subjects|||Number
787313|NCT00849875|Secondary|Number of Patients With Abnormal Hyponatremia (hNA) Values by Maximum Grade|The status of each patient as regards hNA laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0) and G1. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of GSK2132231A.||Subjects|||Number
787314|NCT00849875|Secondary|Number of Patients With Abnormal Hypokalemia (hKA) Values by Maximum Grade|The status of each patient as regards hKA laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0) and G1. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of GSK2132231A.||Subjects|||Number
787315|NCT00849875|Secondary|Number of Patients With Abnormal Hypocalcemia(hCA) Values by Maximum Grade|The status of each patient as regards hCA laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Unknown (UNK), Grade 0 (G0) and G1. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of GSK2132231A.||Subjects|||Number
787316|NCT00849875|Secondary|Number of Patients With Abnormal Hypoalbuminemia(hAL) Values by Maximum Grade|The status of each patient as regards hAL laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Unknown (UNK), Grade 0 (G0) and G1. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of GSK2132231A.||Subjects|||Number
787317|NCT00849875|Secondary|Number of Patients With Abnormal Hypernatremia (HNA) Values by Maximum Grade|The status of each patient as regards HNA laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0) and G1. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of GSK2132231A.||Subjects|||Number
787318|NCT00849875|Secondary|Number of Patients With Abnormal Hyperkalemia (HKA) Values by Maximum Grade|The status of each patient as regards HKA laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0), G1 and G2. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of GSK2132231A.||Subjects|||Number
787319|NCT00849875|Secondary|Number of Patients With Abnormal Hypercalcemia (HCA) Values by Maximum Grade|The status of each patient as regards HCA laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Unknown (UNK), Grade 0 (G0) and G1. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of GSK2132231A.||Subjects|||Number
787320|NCT00849875|Secondary|Number of Patients With Abnormal Hemoglobin (HGB) Values by Maximum Grade|The status of each patient as regards HGB laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0) and G1. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of GSK2132231A.||Subjects|||Number
787321|NCT00849875|Secondary|Number of Patients With Abnormal Gamma-glutamyl Transpeptidase (GGT) Values by Maximum Grade|The status of each patient as regards GGT laboratory values at baseline (SCR) up to study end(SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0), G1 and G3. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of GSK2132231A.||Subjects|||Number
787322|NCT00849875|Secondary|Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade|The status of each patient as regards CREA laboratory values at baseline (SCR) up to study end(SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0). CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of GSK2132231A.||Subjects|||Number
787323|NCT00849875|Secondary|Number of Patients With Abnormal Bilirubine (BIL) Values by Maximum Grade.|The status of each patient as regards BIL laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Unknown (UNK) and Grade 0 (G0). CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of GSK2132231A.||Subjects|||Number
787324|NCT00849875|Secondary|Number of Patients With Abnormal Alkaline Phosphatase (ALK) Values by Maximum Grade|The status of each patient as regards ALK laboratory values at baseline (SCR) up to study end(SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0) and G1. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of GSK2132231A.||Subjects|||Number
787325|NCT00849875|Secondary|Number of Patients With Abnormal Aspartate Aminotransferase (AST) Values by Maximum Grade|The status of each patient as regards AST laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0) and G1. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of GSK2132231A.||Subjects|||Number
787326|NCT00849875|Secondary|Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade|The status of each patient as regards ALT laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0), G1 and G2. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of the GSK2132231A product.||Subjects|||Number
787328|NCT00849875|Secondary|Progression-free Survival (PFS) After Slow Progressive Disease (SPD) by Gene Signature|PFS after initial SPD was defined and calculated as the time from the time point at which the disease was the most advanced during the treatment to either a new progression of the disease or the date to death, whichever occurred first as another secondary outcome of this study. In that case, the largest diameter during the course of treatment was to be used as reference measurement. This outcome was defined to take into account the delay to induce an active immune response and the strict rules set up in this study to allow pursuing investigational treatment in case of SPD. PFS after SPD analysis was performed using the non-parametric Kaplan-Meier method.|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of the GSK2132231A product.||Months||95% Confidence Interval|Median
787329|NCT00849875|Secondary|Progression-free Survival (PFS) by Gene Signature|PFS was defined and calculated as the time from first treatment to either the first progression of the disease or the date of death, whichever occurred first. In case a patient went off protocol treatment, the date of first documented progression (if applicable) was to be used as date of progression. Patients still alive with no evidence of disease progression at the time of their last visit or for whom date of first documented progression was not applicable, were censored at the time of the last examination. PFS analysis was performed using the non-parametric Kaplan-Meier method.|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of the GSK2132231A product.||Months||95% Confidence Interval|Median
787330|NCT00849875|Secondary|Progression-free Survival (PFS) for the Overall Population|PFS was defined and calculated as the time from first treatment to either the first progression of the disease or the date of death, whichever occurred first. In case a patient went off protocol treatment, the date of first documented progression (if applicable) was to be used as date of progression. Patients still alive with no evidence of disease progression at the time of their last visit or for whom date of first documented progression was not applicable, were censored at the time of the last examination. PFS analysis was performed using the non-parametric Kaplan-Meier method.|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of the GSK2132231A product.||Months||95% Confidence Interval|Median
787331|NCT00849875|Secondary|Time to Treatment Failure (TTF), by Gene Signature|TTF was defined as withdrawal from treatment with the MAGE-A3 ASCI study product due to disease progression or death. TTF analysis was performed using the non-parametric Kaplan-Meier method.|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of the GSK2132231A product.||Months||95% Confidence Interval|Median
787332|NCT00849875|Secondary|Number of Patients With Mixed Response (MxR) to MAGE-A3 ASCI Study Treatment|Assessment was done based on a set of MLs identified at baseline as TLs and NTLs followed up until disease progression. MLs were assessed as regards matching below MxR definitions. In case of evaluability per RECIST: a) MxR Type 1= at least (a.l.) 30% decrease in LD in a.l. one TL measured at baseline. Such response occurring in SD/PD status of LD of TL and without appearance of one or more new lesions = SD/PD with TL regression; b) MxR Type 2: appearance of one or more new lesions occurring in SD/PR status of LD of TL, and = SD/PR with new lesion. In case of non-evaluability per RECIST: a) MxR Type 1 = a clear decrease in diameters occurring in a.l. one TL measured at baseline. Such response occurring in SD/PD status of LD of (baseline) TL and without appearance of one or more new lesions = SD/PD with TL regression; b) MxR Type 2 = appearance of one or more new lesions occurring in SD/PR status of LD of TL = SD/PR with new lesion.|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of the GSK2132231A product.||Patients|||Number
787333|NCT00849875|Secondary|Duration of Stable Disease (SD) Response to MAGE-A3 ASCI Study Treatment|Assessment was done based on a set of MLs identified at baseline as TLs and NTLs followed up until disease progression. Stable disease was defined as follows: 1) In case of target lesions (TL) greater than or equal to (≥) 20 mm: neither sufficient shrinkage to qualify for Partial Response nor sufficient increase to qualify for Progressive Disease, taking as references the sum of Longest Diameter (LD) of TL recorded previously but not necessarily at baseline; 2) In case of TL both less than 20 mm and ≥ 20 mm: Neither sufficient shrinkage to qualify as a PR nor sufficient increase to qualify as PD, taking as references the smallest sum LD since the start of the treatment. The minimal time interval required between 2 measurements for determination of SD was at least 12 weeks.|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of the GSK2132231A product.||Months||95% Confidence Interval|Median
787334|NCT00849875|Secondary|Number of Patients With Stable Disease (SD) Response to MAGE-A3 ASCI Study Treatment|Assessment was done based on a set of MLs identified at baseline as TLs and NTLs followed up until disease progression. TLs and NTLs were assessed as regards matching or not SD-related definitions, 1) SD definitions per Response Evaluation Criteria in Solid Tumors (RECIST) criteria for TLs >= 20 mm and TLs both >= and < 20 mm: a) for TLs: SD = Neither sufficient shrinkage to qualify as a PR nor sufficient increase to qualify as PD, taking as references the smallest sum LD since treatment start. and b) for NTLs: SD = Persistence of one or more NTL; 2) following below criteria for TLs < 20mm e. a. a) for TLs: PR/SD = Neither sufficient shrinkage to qualify for CR nor sufficient increase, to qualify for PD taking as references the smallest sum LD since treatment start, and b) for NTLs: PR/SD = Persistence of one or more NTL.|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of the GSK2132231A product.||patients|||Number
787335|NCT00849875|Secondary|Number of Patients With Objective Tumor Response (OR) to MAGE-A3 ASCI Study Treatment|Response assessment was done based on a set of measurable lesions (MLs) identified at baseline as target lesions (TLs), and followed up until disease progression. Up to 5 MLs per organ & 10 in total were identified as TLs and measured at baseline, selected based on size (those with the longest diameter [LD]) and measurability; a sum of LDs for all TLs was calculated and reported as baseline sum LD, which was used to characterize objective tumor response (OR), OR being defined as either complete response (CR) and/or partial response (PR) post MAGE-A3 ASCI treatment. After identification, MLs and TLs were assessed as regards CR and PR definitions per Response Evaluation Criteria in Solid Tumors (RECIST) criteria: CR = Disappearance of all extranodal target lesions. All pathological lymph nodes must have decreased to <10 mm in short axis; PR = At least a 30% decrease in the SLD of target lesions, taking as reference the baseline sum diameters.|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of the GSK2132231A product.||patients|||Number
787337|NCT00849875|Primary|Number of Patients With Treatment Response for Anti-PD|Treatment response defined as: For initially seronegative patients: post-administration antibody concentration ≥ 100 EL.U/mL For initially seropositive patients: post-administration antibody concentration ≥ 2 fold the pre-vaccination antibody concentration|Post Dose 4 at Week 13 (W13).|The ATP population for Immunogenecity included all eligible patients, who have received at least the first 4 GSK2132231A doses concomitantly to the standard chemotherapy regimen and provided a valid result for immunogenecity measurement within the 4 weeks following the 4th dose.||Patients|||Number
787338|NCT00849875|Primary|Concentrations of Antibodies Against Protein D (Anti-PD)|Anti-PD antibody concentrations were presented ad geometric mean concentrations (GMTs) and expressed in ELISA units per millilitre (EL.U/mL).|Post Dose 4 at Week 13 (W13).|The ATP population for Immunogenecity included all eligible patients, who have received at least the first 4 GSK2132231A doses concomitantly to the standard chemotherapy regimen and provided a valid result for immunogenecity measurement within the 4 weeks following the 4th dose.||EL.U/mL||95% Confidence Interval|Geometric Mean
787339|NCT00849875|Primary|Number of Patients With Treatment Response for Anti-MAGE-A3 Antibodies|Treatment response defined as: For initially seronegative patients: post-administration antibody concentration ≥ 27 EL.U/mL For initially seropositive patients: post-administration antibody concentration ≥ 2 fold the pre-vaccination antibody concentration|Post Dose 4 at Week 13 (W13).|The ATP population for Immunogenecity included all eligible patients, who have received at least the first 4 GSK2132231A doses concomitantly to the standard chemotherapy regimen and provided a valid result for immunogenecity measurement within the 4 weeks following the 4th dose.||Patients|||Number
787340|NCT00849875|Primary|Anti-MAGE-A3 Antibody Concentrations|Anti-MAGE-A3 antibody concentrations were presented as geometric mean concentrations (GMTs) and expressed in ELISA units per millilitre (EL.U/mL)|Post Dose 4 at Week 13 (W13).|The ATP population for Immunogenecity included all eligible patients, who have received at least the first 4 GSK2132231A doses concomitantly to the standard chemotherapy regimen and provided a valid result for immunogenecity measurement within the 4 weeks following the 4th dose.||EL.U/mL||95% Confidence Interval|Geometric Mean
787341|NCT00849875|Primary|Number of Seroconverted Patients for Melanoma Antigen (Anti-MAGE-A3)|Seroconversion was defined as a concentration of antibodies assessed that was greater than the cut-off value for a patient whose concentration of such antibodies was below the cut-off level before the initiation of treatment. Seroconverted patients were those patients with anti-MAGE-A3 antibody concentrations ≥ 27.|Post Dose 4 at Week 13 (W13).|The Total Treated population included all patients who have received at least one dose of the GSK2132231A product.||Patients|||Number
787342|NCT00849875|Primary|Number of Patients Reported With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Events which were part of the natural course of the disease under study (i.e., disease progression, recurrence) were captured as part of the clinical activity outcome variables in this study; therefore these did not need to be reported as SAEs. Progression/recurrence of the tumor in a patient was recorded as part of the clinical assessment data collection, and deaths due to progressive disease was recorded on a specific form, but not as an SAE. However, if the investigator considered that there was a causal relationship between treatment or protocol design/procedures and the disease progression/recurrence, then the event was reported as an SAE. Any new primary cancer (non-related to the cancer under study) was reported as an SAE.|During the entire study period, up to 5 years|The Total Treated population included all patients who have received at least one dose of the GSK2132231A product.||Patients|||Number
787343|NCT00849875|Primary|Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade.|The assessed AEs were ASCI-related grade 3/4 adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. An unsolicited AE covers any untoward medical occurrence in a clinical investigation patient temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Related = AE assessed by the investigator as related to the treatment.|Within the 31-day (Days 0-30) post-administration period.|The Total Treated population included all patients who have received at least one dose of the GSK2132231A product.||Patients|||Number
787344|NCT00849901|Secondary|Percentage of Participants With Potentially Clinically Significant (PCS) Changes in Systolic Blood Pressure (BP), Diastolic BP, Pulse, and Weight Any Time Week 10 Through Week 36|PCS increase in systolic and diastolic BP was defined as increase of ≥ 5mm Hg from baseline (BL) high value to a value above the 95th percentile at post-BL; PCS increase of pulse was defined as >140 and increase of ≥15 from BL high value for age 7-11 and >120 and increase of ≥15 from BL high value for age 12-17; PCS decrease of pulse was defined as <60 and a decrease of ≥25 from BL low value for age 7-11 and <50 and a decrease of ≥15 from BL low value for age 12-17; PCS decrease of weight was defined as decrease of at least 3.5% from BL low value.|Week 10 through Week 36|Participants with normal value at last non-missing visit before Week 10 and at least one non-missing post-Week 10 value, and who are at risk for the specific PCS criteria.||percentage of participants|||Number
787345|NCT00849901|Secondary|Percentage of Participants With Potentially Clinically Significant (PCS) Changes in Systolic Blood Pressure (BP), Diastolic BP, Pulse, and Weight Any Time Baseline Through Week 10|PCS increase in systolic and diastolic BP was defined as increase of ≥5 millimeter mercury (mm Hg) from baseline (BL) high value to a value above the 95th percentile at post-BL; PCS increase of pulse was defined as >140 and increase of ≥15 from BL high value for age 7-11 and >120 and increase of ≥15 from BL high value for age 12-17; PCS decrease of pulse was defined as <60 and a decrease of ≥25 from BL low value for age 7-11 and <50 and a decrease of ≥15 from BL low value for age 12-17; PCS decrease of weight was defined as decrease of at least 3.5% from BL low value.|Baseline through Week 10|Participants with normal baseline value and at least one post-baseline value, and who were at risk for the specific PCS criteria.||percentage of participants|||Number
787385|NCT00850200|Primary|Comparison of Normal Tissue Exposed to Greater Than or Equal to 4 Gy/CGE With Use of Proton Therapy Compared to Both Intensity Modulated Radiotherapy (IMRT) and Conventional Therapy.||Immediately proceeding completion of each of the three treatment plans|||percentage of body receiving 4 Gy||Full Range|Median
787346|NCT00849901|Secondary|Number of Participants With Potentially Clinically Significant Hepatic Laboratory Results Any Time Week 10 Through Week 36|Total number of participants with any abnormal post-baseline value, based on all values at scheduled and unscheduled visits. Potentially clinically significant hepatic laboratory results at any time are defined as alanine transaminase (ALT) ≥3 x upper limit of normal (ULN), ALT ≥5 x ULN and ALT ≥10 x ULN, as well as ALT ≥3 x ULN and Total Bilirubin ≥2 x ULN.|Week 10 through Week 36|Participants with normal ALT value (ALT<1 x ULN) at last non-missing visit before Week 10 and at least one non-missing post-Week 10 value.||participants|||Number
787347|NCT00849901|Secondary|Number of Participants With Potentially Clinically Significant Hepatic Laboratory Results Any Time Baseline Through Week 10|Total number of participants with any abnormal post-baseline value, based on all values at scheduled and unscheduled visits. Potentially clinically significant hepatic laboratory results at any time are defined as alanine transaminase (ALT) ≥3 x upper limit of normal (ULN), ALT ≥5 x ULN and ALT ≥10 x ULN, as well as ALT ≥3 x ULN and Total Bilirubin ≥2 x ULN.|Baseline through Week 10|Participants with normal ALT value (ALT <1 x ULN) at last non-missing baseline visit and at least one non-missing post-baseline value.||participants|||Number
787348|NCT00849901|Secondary|Number of Participants With Suicidal Ideation or Suicidal Behavior Week 10 Through Week 36|"Columbia Suicide Rating Scale (C-SSRS) captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior: a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a yes answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Treatment Emergent Suicidal Ideation is worsening or new occurrence of events during treatment compared to lead-in baseline (Week 7-10)."|Week 10 through Week 36|Participants with at least one post-baseline C-SSRS suicidal ideation or suicidal behavior score and who are at risk for treatment emergent suicidal ideation or behavior.||participants|||Number
787349|NCT00849901|Secondary|Number of Participants With Suicidal Ideation or Suicidal Behavior Baseline Through Week 10|"Columbia Suicide Rating Scale (C-SSRS) captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior: a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a yes answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Treatment Emergent Suicidal Ideation is worsening or new occurrence of events during treatment compared to lead-in baseline (Week -1 - 0)."|Baseline through Week 10|Participants with at least one post-baseline C-SSRS suicidal ideation or suicidal behavior score and who are at risk for treatment emergent suicidal ideation or behavior.||participants|||Number
787350|NCT00849901|Secondary|Change From Week 10 in Clinical Global Impressions of Severity (CGI-Severity) Scale at Week 36 Endpoint|CGI-Severity evaluates the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). LS means are adjusted for baseline, pooled investigator, age category, visit, age category*visit and baseline*visit.|Week 10, Week 36|Participants with value during treatment phase and at least one post-Week 10 value.||units on a scale||Standard Error|Least Squares Mean
787351|NCT00849901|Secondary|Change From Baseline in Clinical Global Impressions of Severity (CGI-Severity) Scale at Week 10 Endpoint|CGI-Severity evaluates the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). LS means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment*visit, age category*visit and baseline*visit.|Baseline, Week 10|Participants with both a baseline and at least one post-baseline value.||units on a scale||Standard Error|Least Squares Mean
787352|NCT00849901|Secondary|Change From Week 10 in Children's Depression Rating Scale-Revised (CDRS-R) Subscale Score at Week 36 Endpoint|CDRS-R Subscale scores include Mood (Sum of items 8, 11, 14, 15), Somatic (Sum of items 4-7, 16, 17), Subjective (Sum of items 9, 10, 12, 13) and Behavior (Sum of items 1-3). Mood and Subjective subscale scores range from 4 to 28; Somatic subscale scores range from 6 to 36; Behavior subscale scores range from 3 to 21. Higher score indicates greater severity of disease. LS means are adjusted for baseline, pooled investigator, age category, visit, age category*visit and baseline*visit.|Week 10, Week 36|Participants with value during treatment phase and at least one post-Week 10 value.||units on a scale||Standard Error|Least Squares Mean
787353|NCT00849901|Secondary|Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Subscale Score at Week 10 Endpoint|CDRS-R Subscale scores include Mood (Sum of items 8, 11, 14, 15), Somatic (Sum of items 4-7, 16, 17), Subjective (Sum of items 9, 10, 12, 13) and Behavior (Sum of items 1-3). Mood and Subjective subscale scores range from 4 to 28; Somatic subscale scores range from 6 to 36; Behavior subscale scores range from 3 to 21. Higher score indicates greater severity of disease. LS means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment*visit, age category*visit and baseline*visit.|Baseline, Week 10|Participants with both a baseline and at least one post-baseline value.||units on a scale||Standard Error|Least Squares Mean
787354|NCT00849901|Secondary|Change From Week 10 in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 36 Endpoint|CDRS-R Total score measure the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. LS means are adjusted for baseline, pooled investigator, age category, visit, age category*visit and baseline*visit.|Week 10, Week 36|Participants with value during treatment phase and at least one post-Week 10 value.||units on a scale||Standard Deviation|Least Squares Mean
787355|NCT00849901|Primary|Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 10 Endpoint|CDRS-R Total score measure the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. Least Square (LS) means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment*visit, age category*visit and baseline*visit.|Baseline, Week 10|Participants with both a baseline and at least one post-baseline value.||units on a scale||Standard Error|Least Squares Mean
787358|NCT00849940|Primary|Accuracy of NIRS Sensor to Estimate Hepatic Tissue Oxygen Saturation|The hepatic tissue oxygen saturation (%) is determined from simultaneous arterial and venous blood samples processed through a blood gas machine. The blood oxygen saturation of the samples are entered into an equation to yield the best estimate of hepatic tissue oxygen saturation. This value is then compared to the NIRS oxygen saturation (%) displayed on the monitor. Accuracy is used to describe how close the NIRS oxygen saturation is to the hepatic tissue oxygen saturation. It can be expressed in terms of shots on target: bias (%) = how close are the shots to the bulls eye and precision (%) is how close are the shots to each other.|Data collected from individual participants over 4 hour timeframe.|Weight 2.9 - 25.4 kg; age 0.04 - 10.2 years represent the values of the participants analyzed.||percentage of oxygen saturation||Standard Deviation|Mean
787359|NCT00849940|Primary|Accuracy of NIRS Sensor to Estimate Intestine Tissue Oxygen Saturation|The intestine tissue oxygen saturation (%) is determined from simultaneous arterial and venous blood samples processed through a blood gas machine. The blood oxygen saturation of the samples are entered into an equation to yield the best estimate of intestine tissue oxygen saturation. This value is then compared to the NIRS oxygen saturation (%) displayed on the monitor. Accuracy is used to describe how close the NIRS oxygen saturation is to the intestine tissue oxygen saturation. It can be expressed in terms of shots on target: bias (%) = how close are the shots to the bulls eye and precision (%) is how close are the shots to each other.|Data collected from individual participants over 4 hour timeframe.|Weight 2.9 - 24.0 kg; age 0.04 - 9.8 years represent the values of the participants analyzed.||percentage of oxygen saturation||Standard Deviation|Mean
787360|NCT00849940|Primary|Accuracy of NIRS Sensor to Estimate Flank Tissue Oxygen Saturation|"The flank tissue oxygen saturation (%) is determined from simultaneous arterial and venous blood samples processed through a blood gas machine. The blood oxygen saturation of the samples are entered into an equation to yield the best estimate of flank tissue oxygen saturation. This value is then compared to the NIRS oxygen saturation (%) displayed on the monitor. Accuracy is used to describe how close the NIRS oxygen saturation is to the flank tissue oxygen saturation. It can be expressed in terms of shots on target: bias (%) = how close are the shots to the bulls eye and precision (%) is how close are the shots to each other.
oxygen saturation when measured displayed NIRS value of the tissue sensor placed over the flank to a reference CO-oximetry model, reported as bias and precision. The model is weighted as 30:70 arterial: central venous oxygen saturation when measured by blood gas co-oximetry."|Data collected from individual participants over 4 hour timeframe.|Weight range 3.9 - 49.5 kg; age 0.2 - 12.3 years represent the values of the participants analyzed.||percentage of oxygen saturation||Standard Deviation|Mean
787361|NCT00850031|Secondary|Improvement of Near Uncorrected Visual Acuity|Mean subjective rating via questionnaire on 1 to 7 rating scale (1= very dissatisfied and 7 = very satisfied).|12 months|||units on a scale||Standard Deviation|Mean
787362|NCT00850031|Primary|Improvement in Uncorrected Near Visual Acuity|Percent of subjects who achieved UCNVA of 20/40 or better.|12 months|||percentage of participants|||Number
787363|NCT00850070|Secondary|Parent Global Assessment (PGA) Scale||Baseline, 8 weeks, and 16 weeks||||||
787364|NCT00850070|Secondary|Social Responsiveness Scale (SRS)|The SRS is a 65-item scale used to measure the severity of symptoms in ASD as they occur in natural social settings. The SRS is comprised of 1 Total scale and 5 subscales that generate raw scores that can be converted to standard T-scores (with mean of 50 and standard deviation of 10) for gender and rater type; standard scores were selected for use in this study. A total T-score of 76 or higher is considered severe and strongly associated with a clinical diagnosis of autistic disorder. A t-score of 60-75 is in the mild to moderate range and considered typical for children with mild or 'high-functioning' ASD, while a T-score of 59 or less suggests an absence of ASD symptoms. A total raw score of >75 were associated with a sensitivity value of .85 and a specificity value of .75 for ASD. Difference in scores between baseline and week 16 were used as an indicator of change.|Primary outcome assessment used two time points, baseline and 16 weeks.|Intent-to-treat analysis; all subjects included. Includes mean at 16-week outcome.||units on a scale||Standard Deviation|Mean
787365|NCT00850070|Primary|Clinical Global Impression -- Severity (CGI-S) Scale|The CGI-S assessed the number of participants with improved severity illness on the CGI-S scale. This is a summary judgment made by a trained clinician of symptom severity. It is a 7-point scale that rates the severity of the patient's illness at time of assessment with 1 - normal, not at all, to 7 - extremely ill. Mixed-effects regression models via SPSS MIXED determined the main effects attributed to differences by group (BH4 and placebo), time (treated as categorical at levels baseline, 8 weeks, and 16 weeks) and the group-by-time interaction. We used random intercept and trend modeling that accounts for each individual's initial level of symptom severity/functioning and rate of change/time|Baseline, 8 weeks, and 16 weeks. Primary outcome assessment used 2 time points, baseline and 16 weeks.|This was an Intent-to-Treat Analysis with Last Observation Carried Forward.Analyses looked at number of children who improved (from markedly, severely or extremely ill to markedly, mildly or no illness) at 16-week time frame.||participants|||Number
787366|NCT00850070|Secondary|Aberrant Behavior Checklist (ABC) - Inappropriate Speech|Subscale assessing echolalia & other odd speech. Higher subscale scores indicate more symptoms. 4 items comprise the subscale, with range of scores from 0-4. Total score range on this subscale is 0 to 16. Scores are averaged to compute overall score. Difference in scores between baseline and week 16 were used as indicator of change.|Primary outcome assessment used two time points, baseline and 16 weeks.|Intent to treat analysis||units on a scale||Standard Deviation|Mean
787367|NCT00850070|Secondary|Adverse Events Scale||Every 1-2 weeks for 16 weeks||||||
787368|NCT00850070|Secondary|Connor's Preschool ADHD Questionnaire||Baseline, 8 weeks, and 16 weeks||||||
787369|NCT00850070|Secondary|Children's Yale Brown Obsessive Compulsive Scale (C-YBOCS)||Baseline, 8 weeks, and 16 weeks||||||
787392|NCT00850395|Secondary|Number of Participants Taking Concomitant Therapy|Participants taking HIV/AIDS concomitant medication at Month 12, at Baseline and Month 12 were reported. It included Emtricitabine/tenofovir disoproxil fumarate(FTC/TDF),Raltegravir(RAL), Ritonavir (RTV), Darunavir(DRV), Kaletra, Atazanavir sulfate(ATV), Abacavir sulfate/lamivudine(ABC/LAM), Tenofovir disoproxil fumarate(TDF), Etravirine(ETR), Lamivudine (LAM), Zidovudine W/lamivudine(ZDV W/LAM), Nevirapine(NVP), Saquinavir mesilate(SQV), Trizivir(TZV), Zidovudine(ZDV), Abacavir sulfate(ABC), Emtricitabine(FTC),Entecavir(ETV).|Baseline, Month 12|FAS population included all participants who received at least one dose (including partial doses) of study medication.||participants|||Number
787370|NCT00850070|Secondary|Vineland Adaptive Behavior Scale-II.|the Vineland-2 is a semi-structured interview designed to assess communicatino, daily living, socialization and motor skills. The Vineland-2 is comprised of a total Adaptive Composite scale; we chose to use 10 subscales that specifically address functional domains relevant for a young ASD sample - Receptive Communication, Expressive Communication, Personal Daily Living Skills, Domestic Daily Living Skills, Community Daily Living Skills, Interpersonal Relations, Play Skills, Coping Skills, Gross Motor Skills, Fine Motor Skills. Scales generate raw or sum, V-, and age-equivalent scores; raw scores were selected for use in the study. Raw score ranges from 0 to 108 depending on the scale. Total raw scale range is from 0 to 766. Subscale scores are averaged to create the total adaptive behavior composite. Higher subscale scores indicate more skills. Difference between baseline and week 16 was used as an indicator of change.|Primary outcome assessment used two time points, baseline and 16 weeks.|Intent-to-treat analysis; all subjects included. Includes mean at 16-week outcome.||units on a scale||Standard Deviation|Mean
787371|NCT00850070|Secondary|Preschool Language Scale-Fourth Edition (PLS-4). Assesses Expressive and Receptive Language Skills in Ages Birth Through 6 Years, 11 Months.|Measures expressive & receptive language and total scores in ages birth to 6 years 11 months. The scales generate raw, standard, and age-equivalent scores; raw scores for the total scale were selected for use in this study. Total is average of subscales. Minimum raw score = 0, maximum = 130. Higher scores indicate better language abilities. Mixed-effects regression models via SPSS MIXED determined the main effects attributed to differences by group (BH4 and placebo), time (treated as categorical at levels baseline, 8 weeks, and 16 weeks) and the group-by-time interaction. For the outcome effect, the difference between baseline and 16 weeks was determined as an indicator for change.|Primary outcome assessment examined the difference in scores between baseline and week 16.|Intent-to-treat analysis; all subjects included. Difference in scores between baseline and 16 weeks was used as treatment outcome.||units on a scale||Standard Deviation|Mean
787372|NCT00850070|Primary|Clinical Global Impression -- Improvement (CGI-I) Scale|The CGI-I assessed the number of participants showing much or very much improvement on the CGI-I scale. This is a summary judgment made by a trained clinician based on observed and reported behaviors of the child compared to baseline. It is a 7-point scale from very much worse (1) to very much improved (7). Chi-square analyses were used to assess change in CHI-I scores (by group, post-test). Mixed-effects regression models via SPSS MIXED determined the main effects attributed to differences by group (BH4 and placebo), time (treated as categorical at levels baseline, 8 weeks, and 16 weeks) and the group-by-time interaction. We used random intercept and trend modeling that accounts for each individual's initial level of symptom severity/functioning and rate of change/time|Weekly for 4 weeks, then monthly, with 16-week end point. Primary outcome assessment used two time points, baseline and 16 weeks.|This was an Intent-to-Treat Analysis with Last Observation Carried Forward.Analyses looked at percentage of children who improved (showing much or very much improved ratings) at 16-week time frame.||participants|||Number
787373|NCT00850096|Secondary|Overall Glycemic Control|Continuous glucose monitoring (CGM) data from patients at the last weeks of study (week 5-6) were averaged for assessment of glycemic control under the treatment of either Nasulin or placebo.|5-6 weeks|47 patients were randomized to the placebo/oral antidiabetic arm while 47 others were randomized to the Nasulin/oral antidiabetic arm of the study. Forty-four patients in the placebo + oral antidiabetic arm and 45 patients in the Nasulin + oral antidiabetic arm completed the study.||mg/dl||Standard Error|Mean
787374|NCT00850096|Primary|Continuous Glucose Monitoring (CGM)|Continuous glucose monitoring (CGM) data from patients receiving either Nasulin or placebo were collected and compared at baseline and the last two weeks of the study, and changes (week 5-6 minus baseline) in the mean percentage of time spend in euglycemia (70 to 180 mg/dl blood glucose) (MPTEU) were assessed from baseline Week 0 to Week 5-6.|Baseline and 5-6 weeks|47 patients were randomized to the placebo/oral antidiabetic arm while 47 others were randomized to the Nasulin/oral antidiabetic arm of the study. Forty-four patients in the placebo + oral antidiabetic arm and 45 patients in the Nasulin + oral antidiabetic arm completed the study.||Percentage of day (24h) in euglycemia||Standard Error|Mean
787375|NCT00850135|Secondary|Pregnancy and Delivery Characteristics for Participants With AUC-130 <= 22,000 and AUC-130 > 22,000|"For our secondary outcome analyses,we chose to focus on AUC-130 because 130 mg/dL is a common threshold used when treating gestational diabetics. In addition, 130 mg/dL was the threshold used in an earlier pilot study performed at our institution because it had the best correlation with birth weight percentile.
Secondary outcomes were compared between these two groups using the chi-square test. Data were analyzed using Stata 11.2. AUC-130 values were divided into “high” and “low” at a cutoff of 22,000, which was the 90th percentile of AUC-130 values."|CGM measured 7 days at beginning of pregnancy,birth weight measured a time of delivery|A total of 57 patients were enrolled from two clinical sites. Of these patients, 44 were screened with the 1-hour 50-g GCT; 9 were screened with 2-hour 75-g GTT. Complete data on secondary outcomes was available for 43 patients with 1-hour 50-g GCT and these were analyzed.||participants|||Number
787376|NCT00850135|Primary|Correlation Between Glucose AUC and Birth Weight.|For each patient’s CGM data, we calculated the total area under the curve (AUC) for values above the predefined cutoffs of 110, 120, 130, 140, and 180 mg/dL. Patients wore the CGM for different amounts of time; therefore, the total AUC for the entire duration of CGM use was divided by the number of 24-hour periods of data collection. We called these normalized values “AUC-110,” “AUC-120,” “AUC-130,” “AUC-140,” and “AUC-180,” and they reflect both the magnitude and duration of hyperglycemic excursions above the predetermined thresholds in an average 24-hour period. Birth weight percentile was determined using birth weight data derived from 1999 and 2000 United States Natality datasets. The correlation coefficient (r) was calculated between birth weight percentiles and each of the following: AUC-110, AUC-120, AUC-130, AUC-140, AUC-180, and 1-hour GCT result.|CGM measured 7 days at beginning of pregnancy,birth weight measured a time of delivery|"A total of 57 patients were enrolled from two clinical sites. Two patients did not have monitoring or delivery data.
Two patients who had an existing diagnosis of diabetes were excluded. The remaining 53 patients were analyzed."||correlation coefficient|||Number
787377|NCT00850174|Secondary|AUC0-t - 10-hydroxy-carbazepine Metabolite|Results of metabolite for informational purposes only|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
787451|NCT00844194|Secondary|Suicidal Thoughts or Behaviours by HAMD-17 at Week 2||Week 2|All patients receiving at least one dose of study medication and having data at week 2.||Participants|||Number
787386|NCT00850343|Secondary|Change From Baseline in Modified Total Sharp Score (mTSS)|"X-ray images of extremities (posteroanterior views of both hands and dorsoplantar views of both feet) were independently assessed by at least two radiographic readers.
The degree of joint destruction was graded by assessing bone erosion in 44 joints and joint space narrowing (JSN) in 42 joints.
The joint erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints in the feet. Each joint was scored, according to the surface area involved, from 0 (no erosion) to 5 (complete collapse of bone). The score for erosion ranges from 0 to 160 in the hands and from 0 to 120 in the feet (the maximum erosion score for a joint in the foot is 10). The JSN score summarizes the severity of JSN in 30 joints of the hands and 12 joints of the feet. JSN, including subluxation, was scored from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. The mTSS ranges from 0 (normal) to 448 (worst)."|Baseline (of Study 275-08-003), Week 0 (of this study) and Week 100|Full analysis set with available mTSS data. Linear extrapolation method was used.||units on a scale||Standard Deviation|Mean
787387|NCT00850343|Secondary|Change From Baseline in Disease Activity Score (DAS) 28|"The DAS28 measures the severity of disease at a specific time and is derived from the following variables:
28 tender joint count;
28 swollen joint count;
Erythrocyte sedimentation rate (ESR);
Patient's global assessment of disease activity.
To obtain the tender joint count and swollen joint count, 28 joints of the shoulder, elbow, wrist, metacarpophalangeal joints, thumb interphalangeal joints, proximal interphalangeal joints, and knee joints were examined.
The data before study drug administration of 275-08-003 Study was utilized for Baseline.
DAS28(ESR) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible ESR. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score of 3.2 or less indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission."|Baseline (of Study 275-08-003), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)|"The full analysis set (FAS) included all randomized participants who received at least one dose of study drug with at least one post-baseline efficacy data point. Last observation carried forward (LOCF) was used. N indicates the number of participants with available data at each time point."||units on a scale||Standard Deviation|Mean
787388|NCT00850343|Secondary|Percentage of Participants With American College of Rheumatology 70% (ACR70) Response|"A participant was an ACR70 responder if the following 3 criteria for improvement from Baseline (before study drug administration in Study 275-08-003) were met:
≥ 70% improvement in 68 tender joint count;
≥ 70% improvement in 66 swollen joint count; and
≥ 70% improvement in at least 3 of the 5 following parameters:
Patient's assessment of arthritis pain (measured on a 100 mm visual analog scale [VAS]);
Patient's global assessment of disease activity (measured on a 100 mm VAS);
Physician's global assessment of disease activity (measured on a 100 mm VAS);
Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));
C-Reactive Protein (CRP)."|Baseline (of Study 275-08-003), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)|The full analysis set (FAS) included all randomized participants who received at least one dose of study drug with at least one post-baseline efficacy data point. Last observation carried forward (LOCF) was used.||percentage of participants||95% Confidence Interval|Number
787389|NCT00850343|Secondary|Percentage of Participants With American College of Rheumatology 50% (ACR50) Response|"A participant was an ACR50 responder if the following 3 criteria for improvement from Baseline (before study drug administration in Study 275-08-003) were met:
≥ 50% improvement in 68 tender joint count;
≥ 50% improvement in 66 swollen joint count; and
≥ 50% improvement in at least 3 of the 5 following parameters:
Patient's assessment of arthritis pain (measured on a 100 mm visual analog scale [VAS]);
Patient's global assessment of disease activity (measured on a 100 mm VAS);
Physician's global assessment of disease activity (measured on a 100 mm VAS);
Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));
C-Reactive Protein (CRP)."|Baseline (of Study 275-08-003), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)|The full analysis set (FAS) included all randomized participants who received at least one dose of study drug with at least one post-baseline efficacy data point. Last observation carried forward (LOCF) was used.||percentage of participants||95% Confidence Interval|Number
787390|NCT00850343|Secondary|Percentage of Participants With American College of Rheumatology 20% (ACR20) Response|"A participant was an ACR20 responder if the following 3 criteria for improvement from Baseline (before study drug administration in Study 275-08-003) were met:
≥ 20% improvement in 68 tender joint count;
≥ 20% improvement in 66 swollen joint count; and
≥ 20% improvement in at least 3 of the 5 following parameters:
Patient's assessment of arthritis pain (measured on a 100 mm visual analog scale [VAS]);
Patient's global assessment of disease activity (measured on a 100 mm VAS);
Physician's global assessment of disease activity (measured on a 100 mm VAS);
Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));
C-Reactive Protein (CRP)."|Baseline (of Study 275-08-003), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)|The full analysis set (FAS) included all randomized participants who received at least one dose of study drug with at least one post-baseline efficacy data point. Last observation carried forward (LOCF) was used.||percentage of participants||95% Confidence Interval|Number
787391|NCT00850343|Primary|Number of Participants With Adverse Events|"An adverse event (AE) is any untoward medical occurrence in a participant administered study drug which did not necessarily have a causal relationship with the treatment. In this study, events that occurred between the time of informed consent and the start of study medication were included in the adverse events for Study 275-08-003. Any event existing prior to the initiation of study treatment that was aggravated after initiation of study treatment was handled as a new event. The investigator assessed the severity of each AE as follows:
Mild: No disruption of normal daily activities; Moderate: Affected normal daily activities; Severe: Inability to perform daily activities.
A serious adverse event is an AE that results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect."|From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.|All participants who received at least one study drug administration were included in the safety analysis population (SAF).||participants|||Number
787394|NCT00850395|Secondary|Number of Participants With Human Immunodeficiency Virus (HIV) Response|Response was defined as a HIV-1 RNA count of less than 50 copies/mL.|Month 12|FAS population included all participants who received at least one dose (including partial doses) of study medication.||participants|||Number
787395|NCT00850395|Secondary|Change From Baseline in Acquired Immune Deficiency Syndrome (AIDS) Clinical Trials Group (ACTG) Symptom Distress Module (SDM) Overall Score at Months 6 and 12|SDM consists of the 20 items questionnaire, each item rated from 0 to 4 where 0 (complete absence of symptom) and 4 (very bothersome symptom). Overall score calculated as the sum of the scores for each of the 20 items of the questionnaire and ranged from 0 (best health) and 80 (worst health). A positive change from baseline indicates a decline in a participant’s quality of life over that period.|Baseline, Months 6, 12|FAS population. 'N' (number of participants analyzed) signifies participants evaluable for this measure. ‘n’ signifies participants evaluable at specified time point. Missing values were imputed only for Month 12 as zero for those participants who either discontinued prematurely before the final visit or had missing baseline measurements.||units on a scale||Standard Deviation|Mean
787396|NCT00850395|Primary|Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 12|Participants were classified based on the severity as mild (Category A), moderate (Category B), and severe (Category C).|Month 12|FAS population included all participants who received at least one dose (including partial doses) of study medication. Missing values were imputed as zero for those participants who either discontinued prematurely before the final visit or had missing baseline measurements.||participants|||Number
787397|NCT00850395|Primary|Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 6|Participants were classified based on the severity as mild (Category A), moderate (Category B), and severe (Category C).|Month 6|FAS population included all participants who received at least one dose (including partial doses) of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||participants|||Number
787398|NCT00850395|Primary|Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 3|Participants were classified based on the severity as mild (Category A), moderate (Category B), and severe (Category C).|Month 3|FAS population included all participants who received at least one dose (including partial doses) of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||participants|||Number
787399|NCT00850395|Primary|Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 12||Baseline, Month 12|FAS population included all participants who received at least one dose (including partial doses) of study medication. Missing values were imputed as zero for those participants who either discontinued prematurely before the final visit or had missing baseline measurements.||cells/mcL||Standard Deviation|Mean
787400|NCT00850395|Primary|Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 6||Baseline, Month 6|FAS population included all participants who received at least one dose (including partial doses) of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||cells/mcL||Standard Deviation|Mean
787401|NCT00850395|Primary|Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 3||Baseline, Month 3|FAS population included all participants who received at least one dose (including partial doses) of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||cells/mcL||Standard Deviation|Mean
787402|NCT00850395|Primary|Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 12||Baseline, Month 12|FAS population included all participants who received at least one dose (including partial doses) of study medication. Missing values were imputed as zero for those participants who either discontinued prematurely before the final visit or had missing baseline measurements.||copies/mL||Standard Deviation|Mean
787403|NCT00850395|Primary|Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 6||Baseline, Month 6|FAS population included all participants who received at least one dose (including partial doses) of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||copies/mL||Standard Deviation|Mean
787404|NCT00850395|Primary|Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 3||Baseline, Month 3|Full Analysis Set (FAS) population included all participants who received at least one dose (including partial doses) of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||copies/mL||Standard Deviation|Mean
787405|NCT00850421|Secondary|To Assess the Effect of BOTX Injections on the Frequency and Intensity of Migraine Episodes in Subjects With Episodic Migraine Headache.||190 days||||||
787406|NCT00850421|Secondary|To Determine Whether Quality of Life is Improved in Subjects Treated With BOTOX Injections for Episodic Migraine Headache.||190 days||||||
787407|NCT00850421|Primary|To Determine Whether Resource Utilization is Decreased in Subjects Treated With BOTOX Injections for Episodic Migraine Headache.||190 days|Mid-enrollment statistical review determined study should not continue, due to recently published BOTOX efficacy data and study design defecits.|||||
787408|NCT00850460|Primary|Individualized Short Form-36 (SF-36) Mean Scores (Physical Component) From Week 0 to Week 8|Scores from the self-administered SF-36 (Physical component) questionnaire were measured at the start (Week 0) of the study and at the end (Week 8) among patients in the placebo- and statin-treated group. Mean scores range from 0 (minimum) - 100 (maximum) with higher mean scores reflecting better outcomes. Measures reported are the means of Week 0 and week 8, measures of dispersion is the range of scores.|Week 0 to Week 8|Three patients from each group completed the questionnaire portion of the study at Week 0 and Week 8.||units on a scale||Full Range|Mean
787409|NCT00850460|Primary|Individualized Neuromuscular Quality of Life (INQoL) Mean Scores From Week 0 to Week 8|Scores from the self-administered INQoL questionnaire will be compared at the start of the study (Week 0) and at the end (Week 8) between the statin-treated group and the placebo group. Scores range from 0-100, with 100 being a better outcome. Measures reported are the means of Week 0 and week 8, measures of dispersion is the range of the results (3 per group).|Week 0 to Week 8|Three patients from each group completed the questionnaire portion of the study at Week 0 and Week 8.||units on a scale||Full Range|Mean
787410|NCT00850499|Secondary|Overall Response Rate|The proportion of subjects who achieve CR, CRu, or partial response (PR) relative to the response evaluable population. Disease response and progression were evaluated according to the modified IWRC criteria by radiographic imaging and other procedures as necessary.|Up to 8 cycles (1 cycle is 35 days: 280 days)|Received at least one dose of study drug||participants|||Number
787411|NCT00850499|Primary|Complete Response Rate|The proportion of response-evaluable subjects who achieved a confirmed complete response (CR) or complete response unconfirmed (CRu). Disease response and progression were evaluated according to modified International Workshop Response Criteria (IWRC) criteria by radiographic imaging and other procedures as necessary.|Up to 8 cycles (1 cycle is 35 days: 280 days)|Received at least one dose of study drug||participants|||Number
787412|NCT00850538|Primary|Number of Participants With Viable Specimens for Genetic Analysis||Tissue samples collected at time of surgery|||participants|||Number
787413|NCT00850564|Secondary|Insulin Stimulated Glucose Utilization|Insulin stimulated glucose uptake (M) is the amount of glucose (measured in mg per kg body weight per minute) taken up during the steady state period of a euglycemic hyperinsulinemic clamp. This measure was calculated for minutes 100-120 of euglycemic hyperinsulinemic clamp procedure at 2 weeks (i.e., after 2 weeks treatment with growth hormone releasing hormone). The measurement at 2 weeks is given here, and, in the statistics section, is statistically compared with the measurement before treatment.|at 2 weeks (i.e., after 2 weeks of treatment)|||mg/kg/min||Standard Error|Mean
787414|NCT00850564|Primary|Mean Overnight Growth Hormone|Outcome is mean overnight growth hormone at 2 weeks (i.e., following 2 weeks of treatment with growth hormone releasing hormone). Growth hormone was measured overnight (from 8pm-7:40am) by frequent blood sampling, and the mean is the average of these frequent measurements. The mean measurement at 2 weeks is given here, and, in the statistics section, is statistically compared with the mean measurement before treatment.|at 2 weeks (i.e., after 2 weeks of treatment)|analysis of 13 participants who completed both baseline and 2 week visits||mcg/L||Standard Error|Mean
787415|NCT00850603|Primary|Geometric Mean Titers (GMTs) for Each Meningococcal Serogroup at Baseline and 28 Days Post-vaccination.|GMTs and their 95% confidence interval to the vaccine meningococcal serogroups at Day 0 and Day 28 post-vaccination.|Baseline (Day 0) and Day 28 post-vaccination|Geometric mean titers were determined in the per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
787416|NCT00850603|Secondary|Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination.|Participants with solicited local and systemic reactions and intensity within 7 days following vaccination with Menomune®|Day 0 to 7 days post-vaccination|||Participants|||Number
787417|NCT00850603|Primary|Percentage of Participants With ≥ 4-Fold Rise in Antibody Titers|Percentage of participants with a 4-fold rise in Serum bactericidal assay using baby rabbit complement (SBA-BR) antibody titers to each meningococcal serogroup from baseline to Day 28 post-vaccination.|Baseline to 28 days post vaccination|4-Fold rise analysis was in the per-protocol population with valid serology data||Percentage of participants|||Number
787418|NCT00850720|Primary|NO Outcomes - Study Terminated Without Data.||Study terminated - no data.||||||
787419|NCT00850759|Primary|Street-crossing Ability|average count of hits/close calls per participant in virtual environment, out of 30 crossings|post-training and again 6 months later|||number of hits/close calls||Standard Deviation|Mean
787420|NCT00850889|Secondary|Subject Assessment of Improvement From Baseline in Nasolabial Fold (NLF) Severity|Subject determination of improvement in NLF severity score on 5-point NLF Severity Scale (0 = None; 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Extreme) two weeks after treatment with Juvéderm with Lidocaine in one NLF and Restylane in the other NLF|Day 0, Day 14|||units on a scale||Standard Deviation|Mean
787421|NCT00850889|Secondary|Investigator Assessment of Improvement Since Baseline in Nasolabial Fold (NLF) Severity|Investigator determination of improvement in NLF severity score on 5-point NLF Severity Scale (0 = None; 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Extreme) two weeks after treatment with Juvéderm with Lidocaine in one NLF and Restylane in the other NLF|Day 0, Day 14|||units on a scale||Standard Deviation|Mean
787422|NCT00850889|Secondary|Comparative Pain|A 5-point scale (-2 = Juvéderm with Lidocaine less painful than Restylane; -1 = Juvéderm with Lidocaine slightly less painful than Restylane; 0 = No difference; 1 = Juvéderm with Lidocaine slightly more painful than Restylane; 2 = Juvéderm with Lidocaine more painful than Restylane). Subjects selected one category from the scale; the percentage of subjects that selected each category is presented.|1 day|||percent of participants|||Number
787423|NCT00850889|Primary|Procedural Pain Score|Subjects evaluated the pain associated with the procedure on an 11-point scale, where 0 is no pain and 10 is the worst pain imaginable.|1 day|||units on a scale||Standard Deviation|Mean
787424|NCT00850993|Secondary|Change From Baseline in Unadjusted Total Serum Bilirubin (TSB) at 48 Hours (ITT Population|Change from Baseline in Unadjusted TSB at 48 Hours (ITT Population)|48 hrs|||TSB (mg/dL)||95% Confidence Interval|Least Squares Mean
787425|NCT00850993|Primary|The Primary Efficacy Endpoint Was the Change in Adjusted Total Serum Bilirubin (TSB) From Baseline to 48 Hours After Treatment.|"The primary efficacy endpoint was the change in adjusted TSB from baseline to 48 hours after treatment.
The adjusted Total Serum Bilirubin (TSB) was a calculation of the percentage difference of the TSB level from the age-specific threshold for PT initiation per the AAP Guidelines, ie, an indication of the distance below the PT threshold at the time."|48 hours after injection|Intent-to-treat population (ITT): Defined as all patients who were randomly assigned treatment in the clinical study, had received stannsoporfin or placebo, and had at least 1 post baseline TSB measurement during the first 48 hours after treatment. Patients were summarized based on randomized treatment.||adjusted TSB (% of Threshold)||95% Confidence Interval|Least Squares Mean
787426|NCT00851006|Secondary|31-phosphorus Magnetic Resonance Spectroscopy Phosphocreatine Metabolite|Phosphocreatine Metabolite is a phosphorylated creatine molecule that plays a role in the production of the energy in the body. Phosphocreatine (PCr) metabolite was quantified by calculating the ratio of PCr over total phosphorus resonance from 31-Phosphorus Magnetic Resonance Spectroscopy.|8 weeks|||ratio of PCr and total phosphorus||Standard Deviation|Mean
787427|NCT00851006|Primary|Mean Children's Depression Rating Scale (CDRS-R) [Reference: Poznanski EO et al. Preliminary Studies of the Reliability and Validity of the Children's Depression Rating Scale. J Am Acad Child Psychiatry. 1984 Mar;23(2):191-7.]|The CDRS-R is a 17-item scale, with items ranging from 1 to 5 or 1 to 7 (possible total score from 17 to 113), rated by a clinician via interviews with the child or parent. Scores ≥40 are indicative of depression, whereas scores ≤28 is often used to define remission|8 weeks|"This outcome measure was not assessed in the Healthy Controls. Only subjects in treatment group were evaluated with CDRS-R and received scores."||Units on a scale||Standard Deviation|Mean
787444|NCT00844194|Secondary|Change of Pulse Rate From Baseline at Week 12||Baseline and Week 12|All patients receiving at least one dose of study medication.||beats per minute (bpm)||Standard Deviation|Mean
787428|NCT00851084|Secondary|Immunogenicity of Intravenous (IV) Aflibercept|The antidrug antibody (ADA) assay was evaluated for participants receiving aflibercept.|Any time post baseline and 90 days after the last infusion of aflibercept, according to baseline status|Participants treated with aflibercept and evaluable for antibody assessment.||participants|||Number
787429|NCT00851084|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAE)|Summary of treatment-emergent adverse events in the safety population. The National Cancer Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE), version 3.0 was used in this study to grade the severity of AEs.|From the date of the first randomization up to 30 days after the treatment discontinuation or until TEAE was resolved or stabilized|Of the total 235 patients included in the safety population, 116 patients received mFOLFOX6 and 119 patients received mFOLFOX6 + aflibercept. One patient, randomly assigned to the mFOLFOX6 arm did not receive any study treatment and was therefore excluded from the safety analyses.||participants|||Number
787430|NCT00851084|Secondary|Overall Survival (OS)|"Overall survival was defined as the time from the date of randomization to the date of death due to any cause. In absence of confirmation of death, survival time was censored at the earliest between the last date the patient was known to be alive and the study cutoff date.
The study was not powered for comparison of OS between the two arms (non-comparative, open-label study)."|From the date of the first randomization until the study data cut-off date, 14 April 2011 (approximately 26 months)|Intent-to-treat population (ITT) – all participants who gave informed consent and were randomized. Of the 268 screened participants, 236 were randomly assigned to treatments, whereas 32 participants were screen failures.||months|Participants|95% Confidence Interval|Median
787431|NCT00851084|Secondary|Overall Objective Response Rate (ORR)|"Summary of overall objective response rate based on tumor assessment by the Independent Review Committee (IRC) as per Response Evaluation Criteria in Solid Tumours (RECIST) criteria. ORR was defined as the proportion of patients with confirmed Complete Response (CR) or confirmed Partial Response (PR) relative to the total number of patients in the analysis population.
Per RECIST v 1.0 target lesions evaluation and assessed by tumor imaging: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): >=30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
The study was not powered for comparison of ORR between the two arms (non-comparative, open-label study)."|From the date of the first randomization until the study data cut-off date, 14 April 2011 (approximately 26 months)|Evaluable Patient population.||percentage of participants||95% Confidence Interval|Number
787432|NCT00851084|Secondary|Progression Free Survival (PFS)|"PFS was defined as the time from the date of randomization to the date of tumor progression or death from any cause, whichever occurred first. PFS was based on tumor assessment by the Independent Review Committee (IRC). PFS was estimated from Kaplan-Meier Curves.
The study was not powered for comparison of PFS between the two arms (non-comparative, open-label study).
Progression was defined using Response Evaluation Criteria In Solid Tumors (RECIST v1.0), as at least a 20 percent increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non target-lesions."|From the date of the first randomization until the study data cut-off date, 14 April 2011 (approximately 26 months)|Evaluable patient (EP) population. A total of 55 patients (32 in the mFOLFOX6 group and 23 in the mFOLFOX6 + aflibercept group) were without an event at the cutoff date for the PFS analysis by IRC.||Months|Participants|95% Confidence Interval|Median
787433|NCT00851084|Primary|Progression Free Survival (PFS) Rate at 12 Months|PFS rate at 12 months was defined as the percentage of patients alive without disease progression at 12 months after randomization. The primary efficacy analysis was based on assessment by the Independent Review Committee (IRC). The study was not powered for comparison of PFS rate at 12 months between the two arms (non-comparative, open-label study). Progression was defined using Response Evaluation Criteria In Solid Tumors (RECIST v1.0), as at least a 20 percent increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non target-lesions.|12 months|Analyses of PFS rate was performed in the evaluable patient (EP) population as the primary analysis population. Overall, 9 patients from the randomized population were excluded from the EP population.||percentage of participants||95% Confidence Interval|Number
787434|NCT00851279|Primary|Percentage of Participants Free From VT at 1 Year Post-Treatment|In order to qualify for inclusion in the chronic success statistic, patients must first be an acute success and must have had no VTs identified in their ICD history post ablation therapy.|1 Year follow-up|||percentage of participants free from VT|||Number
787435|NCT00851318|Secondary|Change From Baseline in Modified Total Sharp Score (mTSS)|"X-ray images of extremities (posteroanterior views of both hands and dorsoplantar views of both feet) were independently assessed by at least two radiographic readers.
The degree of joint destruction was graded by assessing bone erosion in 44 joints and joint space narrowing (JSN) in 42 joints.
The joint erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints in the feet. Each joint was scored, according to the surface area involved, from 0 (no erosion) to 5 (complete collapse of bone). The score for erosion ranges from 0 to 160 in the hands and from 0 to 120 in the feet (the maximum erosion score for a joint in the foot is 10). The JSN score summarizes the severity of JSN in 30 joints of the hands and 12 joints of the feet. JSN, including subluxation, was scored from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. The mTSS ranges from 0 (normal) to 448 (worst)."|Baseline (of Study 275-08-001), Week 0 (of this study) and Week 100|Full analysis set with available mTSS data. Linear extrapolation method was used.||units on a scale||Standard Deviation|Mean
787445|NCT00844194|Secondary|Change of Diastolic Blood Pressure From Baseline at Week 12||Baseline and Week 12|All patients receiving at least one dose of study medication.||mmHg||Standard Deviation|Mean
787446|NCT00844194|Secondary|Change of Systolic Blood Pressure From Baseline at Week 12||Baseline and Week 12|All patients receiving at least one dose of study medication.||mmHg||Standard Deviation|Mean
787447|NCT00844194|Secondary|Change of Glycosylated Hemoglobin A1c (HbA1c) From Baseline at Week 12|Ancova analysis controlling for baseline and insulin intake|Baseline and Week 12|All patients receiving at least one dose of study medication and having data of HbA1c at baseline and at week 12.||percent||95% Confidence Interval|Least Squares Mean
787452|NCT00844194|Secondary|Suicidal Thoughts by BDI-II at Week 12||Week 12|All patients receiving at least one dose of study medication and having data at week 12.||Participants|||Number
787436|NCT00851318|Secondary|Change From Baseline in Disease Activity Score (DAS) 28|"The DAS28 measures the severity of disease at a specific time and is derived from the following variables:
28 tender joint count;
28 swollen joint count;
Erythrocyte sedimentation rate (ESR);
Patient's global assessment of disease activity.
To obtain the tender joint count and swollen joint count, 28 joints of the shoulder, elbow, wrist, metacarpophalangeal joints, thumb interphalangeal joints, proximal interphalangeal joints, and knee joints were examined.
The data before study drug administration of 275-08-001 Study was utilized for Baseline.
DAS28(ESR) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible ESR. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score of 3.2 or less indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission."|Baseline (of Study 275-08-001), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)|The full analysis set (FAS) included all randomized participants who received at least one dose of study drug with at least one post-baseline efficacy data point. Last observation carried forward (LOCF) was used.||units on a scale||Standard Deviation|Mean
787437|NCT00851318|Secondary|Percentage of Participants With American College of Rheumatology 70% (ACR70) Response|"A participant was an ACR70 responder if the following 3 criteria for improvement from Baseline (before study drug administration in Study 275-08-001) were met:
≥ 70% improvement in 68 tender joint count;
≥ 70% improvement in 66 swollen joint count; and
≥ 70% improvement in at least 3 of the 5 following parameters:
Patient's assessment of arthritis pain (measured on a 100 mm visual analog scale [VAS]);
Patient's global assessment of disease activity (measured on a 100 mm VAS);
Physician's global assessment of disease activity (measured on a 100 mm VAS);
Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));
C-Reactive Protein (CRP)."|Baseline (of Study 275-08-001), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)|The full analysis set (FAS) included all randomized participants who received at least one dose of study drug, with at least one post-baseline efficacy data point. Last observation carried forward (LOCF) was used.||percentage of participants||95% Confidence Interval|Number
787438|NCT00851318|Secondary|Percentage of Participants With American College of Rheumatology 50% (ACR50) Response|"A participant was an ACR50 responder if the following 3 criteria for improvement from Baseline (before study drug administration in Study 275-08-001) were met:
≥ 50% improvement in 68 tender joint count;
≥ 50% improvement in 66 swollen joint count; and
≥ 50% improvement in at least 3 of the 5 following parameters:
Patient's assessment of arthritis pain (measured on a 100 mm visual analog scale [VAS]);
Patient's global assessment of disease activity (measured on a 100 mm VAS);
Physician's global assessment of disease activity (measured on a 100 mm VAS);
Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));
C-Reactive Protein (CRP)."|Baseline (of Study 275-08-001), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)|The full analysis set (FAS) included all randomized participants who received at least one dose of study drug with at least one post-baseline efficacy data point. Last observation carried forward (LOCF) was used.||percentage of participants||95% Confidence Interval|Number
787439|NCT00851318|Secondary|Percentage of Participants With American College of Rheumatology 20% (ACR20) Response|"A participant was an ACR20 responder if the following 3 criteria for improvement from Baseline (before study drug administration in Study 275-08-001) were met:
≥ 20% improvement in 68 tender joint count;
≥ 20% improvement in 66 swollen joint count; and
≥ 20% improvement in at least 3 of the 5 following parameters:
Patient's assessment of arthritis pain (measured on a 100 mm visual analog scale [VAS]);
Patient's global assessment of disease activity (measured on a 100 mm VAS);
Physician's global assessment of disease activity (measured on a 100 mm VAS);
Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));
C-Reactive Protein (CRP)."|Baseline (of Study 275-08-001), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)|The full analysis set (FAS) included all randomized participants who received at least one dose of study drug with at least one post-baseline efficacy data point. Last observation carried forward (LOCF) was used.||percentage of participants||95% Confidence Interval|Number
787440|NCT00851318|Primary|Number of Participants With Adverse Events|"An adverse event (AE) is any untoward medical occurrence in a participant administered study drug which did not necessarily have a causal relationship with the treatment. In this study, events that occurred between the time of informed consent and the start of study medication were included in the adverse events for Study 275-08-001. Any event existing prior to the initiation of study treatment that was aggravated after initiation of study treatment was handled as a new event. The investigator assessed the severity of each AE as follows:
Mild: No disruption of normal daily activities; Moderate: Affected normal daily activities; Severe: Inability to perform daily activities.
A serious adverse event is an AE that results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect."|From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.|All participants who received at least one study drug administration were included in the safety analysis population (SAF).||participants|||Number
787441|NCT00851409|Secondary|"The Evaluation of Pharmacokinetic/ Pharmacodynamic (PK/PD)Parameters."|"PK/PD parameters will be based on concentration time curves after the 1st and 8th rhC1INH administration.(ratio visit 8/ visit 1, based on the area under the curve from baseline up to 4 hours after administration (AUC 0-4)"|8 weeks|||ratio||95% Confidence Interval|Geometric Mean
787442|NCT00851409|Primary|HAE Attacks/Week|"Prior to the treatment period, patients enrolled in the study, were asked about the amount of HAE attacks in the past 2 years, (calculated to attacks/week), this number is defined as Historical. During the treatment period, patients received a dose of 50 IU/kg of rhC1INH administered by slow IV injection over 4 to 5 minutes, once a week during an eight week period. The amount of attacks during this period is defined as Prophylaxis (calculated to attacks/week)."|8 weeks|||attacks/week||95% Confidence Interval|Mean
787443|NCT00844194|Primary|Change of Brief Pain Inventory (BPI) Average Interference Score From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. The BPI average interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787455|NCT00844194|Secondary|Change in Hamilton Depression Score From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. A lower score corresponds to a lower level of depression. The score ranges from 0 to 52.|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787456|NCT00844194|Secondary|Change in Hamilton Depression Score From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. A lower score corresponds to a lower level of depression. The score ranges from 0 to 52.|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores of a scale||Standard Deviation|Mean
787457|NCT00844194|Secondary|Change in Hamilton Depression Score From Baseline to Week 2|The change from baseline reflects the week 2 value minus the baseline value. A lower score corresponds to a lower level of depression. The score ranges from 0 to 52.|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787458|NCT00844194|Secondary|Change in Clinical Global Impression - Severity Pain From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. The score of the Clinical global impression ranges from 1 (not ill at all) to 7 (extremely ill).|Baseline and Week 12|||Scores of a scale||Standard Deviation|Mean
787459|NCT00844194|Secondary|Change in Clinical Global Impression - Severity Pain From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. The score of the Clinical global impression ranges from 1 (not ill at all) to 7 (extremely ill).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787460|NCT00844194|Secondary|Change in Clinical Global Impression - Severity Pain From Baseline to Week 2|The change from baseline reflects the week 2 value minus the baseline value. The score of the Clinical global impression ranges from 1 (not ill at all) to 7 (extremely ill).|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787461|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): General Activities From Baseline to Week 12|Frequency with which the patient engages in general activities. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787462|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): General Activities From Baseline to Week 6|Frequency with which the patient engages in general activities. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787463|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Social Activities From Baseline to Week 12|Frequency with which the patient engages in social activities. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787464|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Social Activities From Baseline to Week 6|Frequency with which the patient engages in social activities. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787465|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Outdoor Work From Baseline to Week 12|Frequency with which the patient engages in outdoor work. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787466|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Outdoor Work From Baseline to Week 6|Frequency with which the patient engages in outdoor work. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787467|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Household Chores From Baseline to Week 12|Frequency with which the patient engages in household chores. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787468|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Household Chores From Baseline to Week 6|Frequency with which the patient engages in household chores. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787482|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Support From Baseline to Week 6|Appraisal of support received from spouse, family and significant others. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (no support) to 6 (very much support).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787469|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Degree to Which Significant Others Display Distracting Responses to the Patient's Pain Behaviors and Complaints From Baseline to Week 12|Degree to which significant others display distracting responses to the patient's pain behaviors and complaints. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787470|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Degree to Which Significant Others Display Distracting Responses to the Patient's Pain Behaviors and Complaints From Baseline to Week 6|Degree to which significant others display distracting responses to the patient's pain behaviors and complaints. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787471|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Solicitous Responses From Baseline to Week 12|Degree to which significant others display solicitous responses to the patient's pain behaviors and complaints. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787472|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Solicitous Responses From Baseline to Week 6|Degree to which significant others display solicitous responses to the patient's pain behaviors and complaints. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787473|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Negative Responses From Baseline to Week 12|Degree to which significant others display negative responses to the patient's pain behaviors and complaints. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787474|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Negative Responses From Baseline to Week 6|Degree to which significant others display negative responses to the patient's pain behaviors and complaints. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787475|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Affective Distress From Baseline to Week 12|Affective distress, including ratings of depressed mood, irritability, and tension. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (no distress) to 6 (extreme distress).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787476|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Affective Distress From Baseline to Week 6|Affective distress, including ratings of depressed mood, irritability, and tension. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (no distress) to 6 (extreme distress).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787477|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Life Control From Baseline to Week 12|Perceived life control and ability to solve problems and feelings of personal mastery and competence. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (no control) to 6 (extreme control).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787478|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Life Control From Baseline to Week 6|Perceived life control and ability to solve problems and feelings of personal mastery and competence. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (no control) to 6 (extreme control).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787479|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Pain Severity From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (no control) to 6 (extreme control).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787480|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Pain Severity From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (not at all strong) to 6 (very strong).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787481|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Support Which the Patient Received From Baseline to Week 12|Appraisal of support received from spouse, family and significant others. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (no support) to 6 (very much support).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787483|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Interference of Pain From Baseline to Week 12|Pain-related life interference (with family and marital functioning, work, social activities). The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (no interference) to 6 (extreme interference).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787484|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Interference of Pain (With Subjective Well-being) From Baseline to Week 6|Pain-related life interference (with family and marital functioning, work, social activities). The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (no interference) to 6 (extreme interference).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787485|NCT00844194|Secondary|Change in Short Form Health Survey (SF-12) - Mental Component Summary From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. A lower score corresponds to a lower level of mental health. Values can range from 0 to 100.|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787486|NCT00844194|Secondary|Change in Short Form Health Survey (SF-12) - Mental Component Summary From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. A lower score corresponds to a lower level of mental health. Values can range from 0 to 100.|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787487|NCT00844194|Secondary|Change in Short Form Health Survey (SF-12) - Physical Component Summary From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. A lower score corresponds to a lower level of physical health. Values can range from 0 to 100.|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787488|NCT00844194|Secondary|Change in Short Form Health Survey (SF-12) - Physical Component Summary From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. A lower score corresponds to a lower level of physical health. Values can range from 0 to 100.|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787489|NCT00844194|Secondary|Change in HADS Depression Total Score From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. The HADS depression total score ranges from 0 (no depression) to 21 (extreme depression).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787490|NCT00844194|Secondary|Change in HADS Depression Total Score From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. The HADS depression total score ranges from 0 (no depression) to 21 (extreme depression).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787491|NCT00844194|Secondary|Change in HADS Depression Total Score From Baseline to Week 2|The change from baseline reflects the week 2 value minus the baseline value. The HADS depression total score ranges from 0 (no depression) to 21 (extreme depression).|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787492|NCT00844194|Secondary|Change in HADS Anxiety Total Score From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. The HADS anxiety total score ranges from 0 (no anxiety) to 21 (extreme anxiety).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787493|NCT00844194|Secondary|Change in HADS Anxiety Total Score From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. The HADS anxiety total score ranges from 0 (no anxiety) to 21 (extreme anxiety).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787494|NCT00844194|Secondary|Change in Hospital Anxiety and Depression Scale (HADS) Anxiety Total Score From Baseline to Week 2|The change from baseline reflects the week 2 value minus the baseline value. The HADS anxiety total score ranges from 0 (no anxiety) to 21 (extreme anxiety).|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787495|NCT00844194|Secondary|Change in Beck Depression Inventory Total Score (BDI-II) From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. The BDI-II total score ranges from 0 to 63, with a higher score indicating a higher level of depression.|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787496|NCT00844194|Secondary|Change in Beck Depression Inventory Total Score (BDI-II) From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. The BDI-II total score ranges from 0 to 63, with a higher score indicating a higher level of depression.|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787527|NCT00844194|Secondary|Change in Pain During Treatment (BPI) From Baseline to Week 2|The change from baseline reflects the pain at week 2 minus the pain at baseline. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787497|NCT00844194|Secondary|Change in Beck Depression Inventory Total Score (BDI-II) From Baseline to Week 2|The change from baseline reflects the week 2 value minus the baseline value. The BDI-II total score ranges from 0 to 63, with a higher score indicating a higher level of depression.|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787498|NCT00844194|Secondary|Patient Global Impression - Improvement (PGI-I) at Week 12|The investigator judged the improvement of the patient's global impression during treatment. The score ranges from 1 (very much better) to 7 (very much worse).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787499|NCT00844194|Secondary|Patient Global Impression - Improvement (PGI-I) at Week 6|The investigator judged the improvement of the patient's global impression during treatment. The score ranges from 1 (very much better) to 7 (very much worse).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787500|NCT00844194|Secondary|Patient Global Impression - Improvement (PGI-I) at Week 2|The investigator judged the improvement of the patient's global impression during treatment. The score ranges from 1 (very much better) to 7 (very much worse).|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787501|NCT00844194|Secondary|Change in Interference of Pain With Enjoyment of Life (BPI) From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787502|NCT00844194|Secondary|Change in Interference of Pain With Enjoyment of Life (BPI) From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787503|NCT00844194|Secondary|Change in Interference of Pain With Enjoyment of Life (BPI) From Baseline to Week 2|The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787504|NCT00844194|Secondary|Change in Interference of Pain With Sleep (BPI) From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787505|NCT00844194|Secondary|Change in Interference of Pain With Sleep (BPI) From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787506|NCT00844194|Secondary|Change in Interference of Pain With Sleep (BPI) From Baseline to Week 2|The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787507|NCT00844194|Secondary|Change in Interference of Pain With Relations to Other People (BPI) From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787508|NCT00844194|Secondary|Change in Interference of Pain With Relations to Other People (BPI) From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787509|NCT00844194|Secondary|Change in Interference of Pain With Relations to Other People (BPI) From Baseline to Week 2|The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787510|NCT00844194|Secondary|Change in Interference of Pain With Normal Work (BPI) From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787511|NCT00844194|Secondary|Change in Interference of Pain With Normal Work (BPI) From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787512|NCT00844194|Secondary|Change in Interference of Pain With Normal Work (BPI) From Baseline to Week 2|The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787513|NCT00844194|Secondary|Change in Interference of Pain With Walking Ability (BPI) From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787514|NCT00844194|Secondary|Change in Interference of Pain With Walking Ability (BPI) From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787515|NCT00844194|Secondary|Change in Interference of Pain With Walking Ability (BPI) From Baseline to Week 2|The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787516|NCT00844194|Secondary|Change in Interference of Pain With Mood (BPI) From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787517|NCT00844194|Secondary|Change in Interference of Pain With Mood (BPI) From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787518|NCT00844194|Secondary|Change in Interference of Pain With Mood (BPI) From Baseline to Week 2|The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787519|NCT00844194|Secondary|Change in Interference of Pain With General Activity (BPI) From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787520|NCT00844194|Secondary|Change in Interference of Pain With General Activity (BPI) From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787521|NCT00844194|Secondary|Change in Interference of Pain With General Activity (BPI) From Baseline to Week 2|The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787522|NCT00844194|Secondary|Change in Relief of Pain (BPI) From the Week Before Baseline to the Week Before Week 12|The change from baseline reflects the week 12 value minus the baseline value. The relief of pain ranges from 0% (no relief) to 100% (complete relief).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||scores on a scale||Standard Deviation|Mean
787523|NCT00844194|Secondary|Change in Relief of Pain (BPI) From the Week Before Baseline to the Week Before Week 6|The change from baseline reflects the week 6 value minus the baseline value. The relief of pain ranges from 0% (no relief) to 100% (complete relief).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||scores on a scale||Standard Deviation|Mean
787524|NCT00844194|Secondary|Change in Relief of Pain (BPI) From the Week Before Baseline to the Week Before Week 2|The change from baseline reflects the week 2 value minus the baseline value. The relief of pain ranges from 0% (no relief) to 100% (complete relief).|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||scores on a scale||Standard Deviation|Mean
787525|NCT00844194|Secondary|Change in Pain During Treatment (BPI) From Baseline to Week 12|The change from baseline reflects the pain at week 12 minus the pain at baseline. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787526|NCT00844194|Secondary|Change in Pain (BPI) From Baseline to Week 6|The change from baseline reflects the pain at week 6 minus the pain at baseline. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787529|NCT00844194|Secondary|Number of Patients With a Reduction in BPI Average Pain at Week 6||Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Participants|||Number
787530|NCT00844194|Secondary|Number of Patients With a Reduction in BPI Average Pain at Week 2||Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Participants|||Number
787531|NCT00844194|Secondary|Change in Average Pain (BPI) From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787532|NCT00844194|Secondary|Change in Average Pain During Treatment (BPI) From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787533|NCT00844194|Secondary|Change in Average Pain (BPI) From Baseline to Week 2|The change from baseline reflects the week 2 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787534|NCT00844194|Secondary|Change in Least Pain (BPI) From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787535|NCT00844194|Secondary|Change in Least Pain During Treatment (BPI) From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787536|NCT00844194|Secondary|Change in Least Pain (BPI) From Baseline to Week 2|The change from baseline reflects the week 2 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787537|NCT00844194|Secondary|Change in Worst Pain (BPI) From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787538|NCT00844194|Secondary|Change in Worst Pain (BPI) From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787539|NCT00844194|Secondary|Change in BPI Worst Pain During Treatment From Baseline to Week 2|The change from baseline reflects the week 2 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787540|NCT00844194|Secondary|Change of Brief Pain Inventory (BPI) Average Interference Score From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. The BPI average interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787541|NCT00844194|Primary|Change of Brief Pain Inventory (BPI) Average Interference Score From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. The BPI average interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
787542|NCT00844298|Secondary|Overall Survival||2 years||||||
787543|NCT00844298|Secondary|Disease(Relapse)-Free Survival||2 years||||||
787544|NCT00844298|Primary|Proportion of Patients Achieving Hematologic and Molecular Complete Remission (CR) After Induction Therapy|approximate time: at the recovery of cytopenia|1 month|||percentage of analyzable subjects|||Number
787545|NCT00844376|Secondary|Plasma Elimination Half-life (t1/2)|Mean of t1/2 = terminal elimination half-life of atorvastatin (test vs reference); measured in hours.|5 days|||hr||Standard Deviation|Mean
787546|NCT00844376|Secondary|Time to Reach Maximum Plasma Concentration (Tmax)|Median of Tmax = time to maximum plasma concentration (Cmax) (test vs reference); measured in hours (hr).|5 days|||hr||Full Range|Median
787547|NCT00844376|Secondary|Terminal Phase Rate Constant (Kel)|Geometric mean of Kel= termination phase rate constant for atorvastatin (test vs reference); measured as 1 per hour (1/hr).|5 days|||1/hr||Full Range|Geometric Mean
787548|NCT00844376|Primary|Maximum Observed Plasma Concentration (Cmax)|Geometric mean of Cmax = maximum observed plasma concentration of atorvastatin (test vs reference); measured in nanograms per milliliter (ng/mL).|5 days|||ng/mL||Full Range|Geometric Mean
788088|NCT00855595|Secondary|Percent Change From Baseline in IL Count at Weeks 2, 4, 6, 8 and 12 (LOCF)|NOTE: Negative mean values represent an improvement (decrease of inflammatory lesions)|Baseline and Week 2, 4, 6, 8 and 12|FAS||Percent of inflammatory lesions||Standard Deviation|Mean
787549|NCT00844376|Secondary|Area Under the Curve From Predose (Time Zero) to Last Quantifiable Concentration (AUClast)|Geometric mean of AUClast = area under the plasma concentration-time curve from time zero (0) to the last measurable concentration of atorvastatin (test vs reference); measured as ng.hr/mL|5 days|||ng.hr/mL||Full Range|Geometric Mean
787550|NCT00844376|Primary|Area Under the Curve From Predose (Time Zero) to Extrapolated Infinite Time (AUC Infinity)|Geometric means of AUC infinity (AUCinf) = area under the plasma concentration-time curve from time zero (0) extrapolated to infinite time; measured in ng.hr/mL of atorvastatin (test vs reference).|5 days|||ng.hr/mL||Full Range|Geometric Mean
787551|NCT00844376|Primary|Area Under the Curve From Predose (Time Zero) to 48 Hours Post-dose (AUC48)|Geometric means of AUC48 = area under the plasma concentration-time profile from time zero (0) to 48 hours postdose of atorvastatin (test versus [vs] reference); measured in nanograms times hour per milliliter (ng.hr/mL).|5 days|||ng.h/mL||Full Range|Geometric Mean
787552|NCT00844415|Secondary|Occurences of Clinical Outcome|Occurrences of clinical outcomes including recurrent venous thrombolic event (VTE), post thrombotic syndrome (PTS), pulmonary emboli (PEs), and total and VTE related mortality objectively assessed for example by ultrasound, venography or computed chromatography (CT) scan (based on the thrombus location). Number of patients with particular clinical outcome are reported.|3 days|TS||Participants|||Number
787553|NCT00844415|Secondary|Patients With Clinically Relevant Changes in Any Laboratory Parameter, Electrocardiogram (ECG) or Vital Signs|Changes in any laboratory parameter, ECG or vital signs were judged clinically relevant by the investigator.|Baseline and 3 days|TS||Participants|||Number
787554|NCT00844415|Secondary|Ecarin Clotting Time (ECT)|Measurement of ECT was performed locally and centrally using validated assays. Descriptive statistics is only performed for the centrally measured ECT.|Day 3|TS with non-sparse data||seconds||Standard Deviation|Mean
787555|NCT00844415|Secondary|aPTT Locally Measured|Measurement of aPTT was performed locally and centrally using validated assays.|Day 3|TS with non-sparse data||seconds||Standard Deviation|Mean
787556|NCT00844415|Secondary|Activated Partial Thromboplastin Time (aPTT) Centrally Measured|Measurement of aPTT was performed locally and centrally using validated assays.|Day 3|TS with non-sparse data||seconds||Standard Deviation|Mean
787557|NCT00844415|Primary|TT Locally Measured|Measurement of TT was performed locally and centrally by Hemoclot Thrombin Inhibitor clotting assay.|Day 3|TS with non-sparse data||seconds||Standard Deviation|Mean
787558|NCT00844415|Primary|Thrombin Time (TT) Centrally Measured|Measurement of TT was performed locally and centrally by Hemoclot Thrombin Inhibitor clotting assay.|Day 3|TS with non-sparse data||seconds||Standard Deviation|Mean
787559|NCT00844415|Primary|Plasma Concentration of Total Dabigatran|Plasma concentration of total dabigatran measured at 72 hours after first dose|Day 3|TS with non-sparse data||ng/ml||Geometric Coefficient of Variation|Geometric Mean
787560|NCT00844415|Primary|Plasma Concentration of Free Dabigatran|Plasma concentration of free dabigatran measured at 72 hours after first dose|3 days|Treated Set. Descriptive statistics for the concentration measurement could only be calculated for the subgroups of patients receiving the same sequence of doses. Statistics were only reported for groups with at least 3 patients (non-sparse data).||ng/ml||Geometric Coefficient of Variation|Geometric Mean
787561|NCT00844415|Primary|Number of Patients With Adverse Events|Patients with treatment drug related adverse events (DRAEs) and serious adverse events (SAEs) are reported separately for on-treatment and post-treatment period. Events were considered „on-treatment“ if occurring within 72 hours after last drug administration.|From Screening until 30 days after first drug administration (end of trial visit)|TS||Participants|||Number
787562|NCT00844415|Primary|Number of Patients With Bleeding Events (Major and Minor)|"Patients were carefully assessed for signs and symptoms of bleeding. Bleeding was to be classified as major or minor. Major bleeding had to satisfy one or more of the following criteria:
Overt bleeding associated with a decrease in haemoglobin of at least 2 g/dL in 24 hours, Overt bleeding requiring a transfusion of red blood cells, Overt bleeding which was retroperitoneal, intracranial, intraocular, or intraarticular, any overt bleeding deemed by the attending physician to require discontinuation of study medication. Minor bleeds were clinical bleeds that did not fulfill the criteria for major bleeds."|From Screening until 30 days after first drug administration (end of trial visit)|Treated set (TS). This patient set includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.||Participants|||Number
787563|NCT00844428|Secondary|Pharmacokinetics (PK) and Pharmacodynamics (PD); Minimum and Maximum Blood Concentration||Induction Phase for 4 weeks followed by Maintenance Phase starting on Week 5 through 26 weeks or longer.|PK parameters Cmin and Cmax were estimated using a population PK model developed from the observed PK concentration data.||micrograms/mil||Standard Deviation|Mean
787564|NCT00844428|Secondary|Percentage of Patients With Platelet Count Normalization|Platelet count normalization was defined as the platelet count observed to be ≥150 x 10^9/L on at least two consecutive measurements which span a period of at least four weeks Not specified.|Through End of Study, Median Exposure 156 Weeks|The tabulations of the proportion of patients who achieved platelet count normalization through end of study were performed for the ITT population. Exact binomial 95% confidence intervals were produced for the analysis.||Percentage of Participants||95% Confidence Interval|Number
787565|NCT00844428|Secondary|Platelet Count Change From Baseline to 156 Weeks||From Baseline to 156 Weeks|Change from baseline platelet counts were analyzed for the ITT population using a repeated measurement ANOVA model. A least squares (LS) mean for the change from baseline was produced for each study day for which a measurement of platelet count was scheduled. Significance of change was assessed at the 5% level at each time point.||10^9 cells/L||95% Confidence Interval|Least Squares Mean
787566|NCT00844428|Secondary|TMA Intervention Rate|TMA Intervention Rate (# PE/PI and # Dialysis Events/Patient/Day) in the eculizumab treatment period (from baseline through end of study) for PE/PI and (from the fifteenth day following the first eculizumab dose through end of study) for new dialysis events was compared with the TMA Intervention Rate during the pre-eculizumab treatment period.|Through End of Study, Median Exposure 156 Weeks|A signed rank test assessed differences in magnitudes of change in TMA intervention rate between the pre-eculizumab treatment period and during eculizumab treatment period for ITT population.||#events/patient/day||Standard Deviation|Mean
787567|NCT00844428|Secondary|Percentage of Patients With Complete TMA Response|The proportion of patients who achieved a Complete TMA Response from baseline through end of study with eculizumab was determined. Complete TMA Response was defined as Hematologic Normalization plus improvement in renal function (defined as (≥25% reduction from baseline in serum creatinine), which was sustained for two consecutive measurements over a period of at least four weeks.|Through End of Study, Median Exposure 156 Weeks|Tabulations of the proportion of patients who achieved a complete TMA response from baseline through end of study were performed. For this endpoint, for any relevant proportions, exact binomial 95% confidence intervals were produced.||Percentage of Participants||95% Confidence Interval|Number
787568|NCT00844428|Secondary|Percentage of Patients With Hematologic Normalization|Hematologic Normalization was defined as normalization of both platelet count and lactic dehydrogenase (LDH) sustained for at least two consecutive measurements which spanned a period of at least four weeks.|Through End of Study, Median Exposure 156 Weeks|Tabulations of the proportion of patients who achieved a hematologic normalization through end of study were performed for the ITT population. Exact 95% binomial confidence intervals were produced for the analysis.||Percentage of Participants||95% Confidence Interval|Number
787569|NCT00844428|Secondary|Percentage of Patients With TMA Event-free Status|TMA Event-free status is defined as the absence for at least 12 weeks of [1] decrease in platelet count of > 25% from the Platelet Count Pre-PT Baseline Set Point; [2] PT while the patient is receiving eculizumab, and [3] new dialysis.|Through End of Study, Median Exposure 156 Weeks|The tabulations of the proportions of patients who achieved a TMA Event-Free status through 26 weeks were performed for the ITT population. Exact binomial 95% confidence intervals were produced for the analysis.||Percentage of Participants||95% Confidence Interval|Number
787570|NCT00844428|Secondary|Percentage of Patients With Platelet Count Normalization|Platelet count normalization was defined as the platelet count observed to be ≥150 x 10^9/L on at least two consecutive measurements which span a period of at least four weeks|Through 26 Weeks|The tabulations of the proportion of patients who achieved platelet count normalization through 26 weeks were performed for the ITT population. Exact binomial 95% confidence intervals were produced for the analysis.||Percentage of Participants||95% Confidence Interval|Number
787571|NCT00844428|Secondary|Platelet Count Change From Baseline to 26 Weeks||From Baseline to 26 Weeks|Change from baseline platelet counts were analyzed for the ITT population using a repeated measurement ANOVA model. A least squares (LS) mean for the change from baseline was produced for each study day for which a measurement of platelet count was scheduled. Significance of change was assessed at the 5% level at each time point.||10^9 cells/L||95% Confidence Interval|Least Squares Mean
787572|NCT00844428|Secondary|TMA Intervention Rate|TMA Intervention Rate (# PE/PI and # Dialysis Events/Patient/Day) in the eculizumab treatment period (from baseline through 26 weeks) for PE/PI and (from the fifteenth day following the first eculizumab dose through 26 weeks) for new dialysis events was compared with the TMA Intervention Rate during the pre-eculizumab treatment period.|Through 26 weeks|A signed rank test assessed differences in magnitudes of change in TMA intervention rate between the pre-eculizumab treatment period and during eculizumab treatment period for ITT population.||#events/patient/day||Standard Deviation|Mean
787573|NCT00844428|Primary|Percentage of Patients With Complete TMA Response|The proportion of patients who achieved a Complete TMA Response from baseline through 26 weeks of treatment with eculizumab was determined. Complete TMA Response was defined as Hematologic Normalization plus improvement in renal function (defined as (≥25% reduction from baseline in serum creatinine), which was sustained for two consecutive measurements over a period of at least four weeks.|Through 26 weeks|Tabulations of the proportion of patients who achieved a complete TMA response from baseline through 26 weeks were performed. For this endpoint, for any relevant proportions, exact binomial 95% confidence intervals were produced.||Percentage of Participants||95% Confidence Interval|Number
787574|NCT00844428|Primary|Percentage of Patients With Hematologic Normalization|Hematologic Normalization was defined as normalization of both platelet count and lactic dehydrogenase (LDH) sustained for at least two consecutive measurements which spanned a period of at least four weeks.|Through 26 weeks|Tabulations of the proportion of patients who achieved a hematologic normalization through 26 weeks were performed for the ITT population. Exact binomial 95% confidence intervals were produced for the analysis.||Percentage of Participants||95% Confidence Interval|Number
787575|NCT00844428|Primary|Percentage of Patients With TMA Event-free Status|TMA Event-free status is defined as the absence for at least 12 weeks of [1] decrease in platelet count of > 25% from the Platelet Count Pre-PT Baseline Set Point; [2] PT while the patient is receiving eculizumab, and [3] new dialysis.|Through 26 weeks|The tabulations of the proportions of patients who achieved a TMA Event-Free status through 26 weeks were performed for the ITT population. Exact binomial 95% confidence intervals were produced for the analysis.||Percentage of Participants||95% Confidence Interval|Number
787576|NCT00844480|Secondary|BMD at Other Skeletal Sites|BMD at spine, femoral neck, distal femur, proximal tibia, heel|6 months|heel measurements were not performed||percentage of baseline BMD||Standard Deviation|Mean
787577|NCT00844480|Primary|Bone Mass Density (BMD) at Total Hip|bone mineral density measured by DXA at the total hip|6 months|||%change in BMD from baseline||Standard Deviation|Mean
787578|NCT00844519|Primary|Percent Change in FMD|endothelial function as assessed by measured flow-mediated vasodilation (FMD) of the brachial artery|Baseline, 24 weeks|||percent change in FMD||Standard Deviation|Mean
787579|NCT00844532|Secondary|Changes in Quality of Life Measures: Mental Component Summary|"This measure indicates the absolute change between two timepoints represented by the mean.
SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient’s point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|Baseline and 3 years|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||scores on a scale||Standard Deviation|Mean
787580|NCT00844532|Secondary|Changes in Quality of Life Measures: Mental Component Summary|"This measure indicates the absolute change between two timepoints represented by the mean.
SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient’s point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|Baseline and 2 years|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||scores on a scale||Standard Deviation|Mean
787581|NCT00844532|Secondary|Changes in Quality of Life Measures: Mental Component Summary|"This measure indicates the absolute change between two timepoints represented by the mean.
SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient’s point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|Baseline and 9 months|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||scores on a scale||Standard Deviation|Mean
787582|NCT00844532|Secondary|Changes in Quality of Life Measures: Mental Component Summary|"This measure indicates the absolute change between two timepoints represented by the mean.
SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient’s point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|Baseline and 1 month|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||scores on a scale||Standard Deviation|Mean
787583|NCT00844532|Secondary|Changes in Quality of Life Measures: Physical Component Summary|"This measure indicates the absolute change between two timepoints represented by the mean.
SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient’s point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|Baseline and 3 years|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||scores on a scale||Standard Deviation|Mean
787584|NCT00844532|Secondary|Changes in Quality of Life Measures: Physical Component Summary|"This measure indicates the absolute change between two timepoints represented by the mean.
SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient’s point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|Baseline and 2 years|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||scores on a scale||Standard Deviation|Mean
787585|NCT00844532|Secondary|Changes in Quality of Life Measures: Physical Component Summary|"This measure indicates the absolute change between two timepoints represented by the mean.
SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient’s point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|Baseline and 9 months|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||scores on a scale||Standard Deviation|Mean
787586|NCT00844532|Secondary|Changes in Quality of Life Measures: Physical Component Summary|"This measure indicates the absolute change between two timepoints represented by the mean.
SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient’s point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|Baseline and 1 month|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||score on a scale||Standard Deviation|Mean
787587|NCT00844532|Secondary|Stent Thrombosis|Stent thrombosis is defined as a total occlusion documented by DUS and/or arteriography at the stent site with or without symptoms that occurs ≤ 30 days post index procedure.|1 month|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.||percentage of limbs|Participants|95% Confidence Interval|Number
787588|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Embolic Events|Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery|3 years|ITT population.This analysis represents those subjects who were event free at this time point.||percentage of participants|||Number
787589|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Embolic Events|Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery|2 years|ITT population.This analysis represents those subjects who were event free at this time point.||percentage of participants|||Number
787590|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Embolic Events|Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery|18 months|ITT population.This analysis represents those subjects who were event free at this time point.||percentage of participants|||Number
787591|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Embolic Events|Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery.|1 month and 9 months|ITT population.This analysis represents those subjects who were event free at this time point.||percentage of participants|||Number
787592|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)|Amputation is defined as the removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.|3 years|ITT population.This analysis represents those subjects with target limbs who were event free at this time point.||percentage of limbs|Participants||Number
787593|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)|Amputation is defined as the removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.|2 years|ITT population.This analysis represents those subjects with target limbs who were event free at this time point.||percentage of limbs|Participants||Number
787594|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)|Amputation is defined as the removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.|18 months|ITT population.This analysis represents those subjects with target limbs who were event free at this time point.||percentage of limbs|Participants||Number
787595|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)|Amputation is defined as the removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.|1 month and 9 months|ITT population.This analysis represents those subjects with target limbs who were event free at this time point.||percentage of limbs|Participants||Number
787596|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)|The term myocardial infarction should be used when there is evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.|3 years|ITT population.This analysis represents those subjects who were event free at this time point.||percentage of participants|||Number
787597|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)|The term myocardial infarction should be used when there is evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.|2 years|ITT population.This analysis represents those subjects who were event free at this time point.||percentage of participants|||Number
787598|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)|The term myocardial infarction should be used when there is evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.|18 months|ITT population.This analysis represents those subjects who were event free at this time point.||percentage of participants|||Number
787599|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)|The term myocardial infarction should be used when there is evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.|1 month and 9 months|ITT population.This analysis represents those subjects who were event free at this time point.||percentage of participants|||Number
787600|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Death (All Cause)|Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years|3 years|ITT population. This analysis represents those subjects who were event free at this time point.||percentage of participants|||Number
787601|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Death (All Cause)|Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years|2 years|ITT population.This analysis represents those subjects who were event free at this time point.||percentage of participants|||Number
787602|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Death (All Cause)|Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years|18 months|ITT population. This analysis represents those subjects who were event free at this time point.||percentage of participants|||Number
787603|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Death (All Cause)|Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years|1 month and 9 months|ITT population. This analysis represents those subjects who were event free at this time point.||percentage of participants|||Number
787604|NCT00844532|Secondary|Restenosis|Defined as ≥ 50% stenosis at follow-up.|3 years|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||percentage of limbs|Participants|95% Confidence Interval|Number
787605|NCT00844532|Secondary|Restenosis|Defined as ≥ 50% stenosis at follow-up.|2 years|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||percentage of limbs|Participants|95% Confidence Interval|Number
787606|NCT00844532|Secondary|Restenosis|Defined as ≥ 50% stenosis at follow-up.|9 months|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||percentage of limbs|Participants|95% Confidence Interval|Number
787607|NCT00844532|Secondary|Primary Stent Patency|Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure.|3 years|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||percentage of limbs|Participants||Number
787608|NCT00844532|Secondary|Primary Stent Patency|Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure.|2 years|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||percentage of limbs|Participants||Number
787609|NCT00844532|Secondary|Primary Stent Patency|Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure.|9 months|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||percentage of limbs|Participants||Number
787610|NCT00844532|Secondary|Primary Stent Patency|Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure.|1 month|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||percentage of limbs|Participants||Number
787611|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)|Any revascularization of a target extremity vessel (distal to the superior border of the inguinal ligament on the ipsilateral side) with or without evidence of vessel diameter stenosis ≥ 50% determined by DUS or arteriography, and with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category).|3 years|ITT population.This analysis represents those subjects with vessels in the extremity with the target lesions, who were event free at this timepoint.||percentage of limbs|Participants||Number
787612|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)|Any revascularization of a target extremity vessel (distal to the superior border of the inguinal ligament on the ipsilateral side) with or without evidence of vessel diameter stenosis ≥ 50% determined by DUS or arteriography, and with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category).|2 years|ITT population. This analysis represents those subjects with vessels in the extremity with the target lesions, who were event free at this timepoint.||percentage of limbs|Participants||Number
787659|NCT00844532|Primary|Major Adverse Event (MAE) Rate|Defined as death, myocardial infarction (MI), clinically-driven target lesion revascularization, and limb loss (major amputation only) on the treated side(s).|9 months|Intent to treat (ITT) population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||percentage of participants||95% Confidence Interval|Number
787613|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)|Any revascularization of a target extremity vessel (distal to the superior border of the inguinal ligament on the ipsilateral side) with or without evidence of vessel diameter stenosis ≥ 50% determined by DUS or arteriography, and with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category).|18 months|ITT population. This analysis represents those subjects with vessels in the extremity with the target lesions, who were event free at this timepoint.||percentage of limbs|Participants||Number
787614|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)|Any revascularization of a target extremity vessel (distal to the superior border of the inguinal ligament on the ipsilateral side) with or without evidence of vessel diameter stenosis ≥ 50% determined by DUS or arteriography, and with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category).|1 month and 9 months|ITT population. This analysis represents those subjects with vessels in the extremity with the target lesions, who were event free at this timepoint.||percentage of limbs|Participants||Number
787615|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (CD-TVR) for the Treated Limb(s)|Revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography).|3 years|ITT population. This analysis represents those subjects with lesions in the target vessel who were event free at this timepoint.||percentage of target vessels|Participants||Number
787616|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (CD-TVR) for the Treated Limb(s)|Revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography).|2 years|ITT population.This analysis represents those subjects with lesions in the target vessel who were event free at this timepoint.||percentage of target vessels|Participants||Number
787617|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (CD-TVR) for the Treated Limb(s)|Revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography).|18 months|ITT population.This analysis represents those subjects with lesions in the target vessel who were event free at this timepoint.||percentage of target vessels|Participants||Number
787618|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (CD-TVR) for the Treated Limb(s)|Revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography).|1 month and 9 months|ITT population. This analysis represents those subjects with lesions in the target vessel who were event free at this timepoint.||percentage of target vessels|Participants||Number
787619|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)|Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) defined: Any revascularization of the target vessel, outside of the target lesion, with or without evidence of diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target vessel.)|3 years|ITT population.This analysis represents those subjects with lesions in the target vessel who were event free at this timepoint.||percentage of target vessels|Participants||Number
787620|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)|Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) defined: Any revascularization of the target vessel, outside of the target lesion, with or without evidence of diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target vessel.)|2 years|ITT population. This analysis represents those subjects with lesions in the target vessel who were event free at this timepoint.||percentage of target vessels|Participants||Number
787621|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)|Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) defined: Any revascularization of the target vessel, outside of the target lesion, with or without evidence of diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target vessel.)|18 months|ITT population.This analysis represents those subjects with lesions in the target vessel who were event free at this timepoint.||percentage of target vessels|Participants||Number
787622|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)|Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) defined: Any revascularization of the target vessel, outside of the target lesion, with or without evidence of diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target vessel.)|1 month and 9 months|ITT population.This analysis represents those subjects with lesions in the target vessel who were event free at this timepoint.||percentage of target vessels|Participants||Number
787623|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)|Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a PTA balloon or stent into a study stent, that has <50% stenosis, while treating a non-target lesion in the target vessel).|3 years|ITT population.This analysis represents those subjects with target lesions who were event free at this timepoint.||percentage of target lesions|Participants||Number
787624|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)|Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a PTA balloon or stent into a study stent, that has <50% stenosis, while treating a non-target lesion in the target vessel).|2 years|ITT population.This analysis represents those subjects with target lesions who were event free at this timepoint.||percentage of target lesions|Participants||Number
787625|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)|Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a PTA balloon or stent into a study stent, that has <50% stenosis, while treating a non-target lesion in the target vessel).|18 months|ITT population.This analysis represents those subjects with target lesions who were event free at this timepoint.||percentage of target lesions|Participants||Number
787626|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)|Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a percutaneous transluminal angioplasty (PTA) balloon or stent into a study stent, that has <50% stenosis, while treating a non-target lesion in the target vessel).|1 month and 9 months|ITT population.This analysis represents those subjects with target lesions who were event free at this timepoint.||percentage of target lesions|Participants||Number
787627|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)|Target lesion revascularization was defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).|3 years|ITT population.This analysis represents those subjects with target lesions who were event free at this timepoint.||percentage of target lesions|Participants||Number
787628|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)|Target lesion revascularization was defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).|2 years|ITT population.This analysis represents those subjects with target lesions who were event free at this timepoint.||percentage of target lesions|Participants||Number
787629|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)|Target lesion revascularization was defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).|18 months|ITT population.This analysis represents those subjects with target lesions who were event free at this timepoint.||percentage of target lesions|Participants||Number
787630|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)|Target lesion revascularization was defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by duplex ultrasonography (DUS) or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).|1 month and 9 months|ITT population.This analysis represents those subjects with target lesions who were event free at this timepoint.||percentage of target lesions|Participants||Number
787631|NCT00844532|Secondary|Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s)|"Change in Rutherford Becker Clinical Category:
Worsening Rutherford Becker Clinical Category:
Deterioration (an increase) in the Rutherford Becker Clinical Category by at least two categories from baseline and subsequently from the earliest post-procedural measurement or to a category 5 or 6.
Improved Rutherford Becker Clinical Category:
An improvement (a decrease) in the Rutherford Becker Clinical Category of at least one category from baseline and subsequently from the earliest post-procedural measurement."|Between baseline and 3 years|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.||Percentage of Limbs|Participants||Number
787632|NCT00844532|Secondary|Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s)|"Change in Rutherford Becker Clinical Category:
Worsening Rutherford Becker Clinical Category:
Deterioration (an increase) in the Rutherford Becker Clinical Category by at least two categories from baseline and subsequently from the earliest post-procedural measurement or to a category 5 or 6.
Improved Rutherford Becker Clinical Category:
An improvement (a decrease) in the Rutherford Becker Clinical Category of at least one category from baseline and subsequently from the earliest post-procedural measurement."|Between baseline and 2 years|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.||Percentage of Limbs|Participants||Number
787633|NCT00844532|Secondary|Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s)|"Change in Rutherford Becker Clinical Category:
Worsening Rutherford Becker Clinical Category:
Deterioration (an increase) in the Rutherford Becker Clinical Category by at least two categories from baseline and subsequently from the earliest post-procedural measurement or to a category 5 or 6.
Improved Rutherford Becker Clinical Category:
An improvement (a decrease) in the Rutherford Becker Clinical Category of at least one category from baseline and subsequently from the earliest post-procedural measurement."|Between baseline and 9 months|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.||Percentage of Limbs|Participants||Number
788089|NCT00855595|Secondary|Nominal Change From Baseline in IL Count at Weeks 4, 6, 8 and 12 (LOCF)|NOTE: Negative mean values represent an improvement (decrease of inflammatory lesions)|Baseline and Week 4, 6, 8 and 12|FAS||Inflammatory lesions||Standard Deviation|Mean
787634|NCT00844532|Secondary|Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s)|"Change in Rutherford Becker Clinical Category:
Worsening Rutherford Becker Clinical Category:
Deterioration (an increase) in the Rutherford Becker Clinical Category by at least two categories from baseline and subsequently from the earliest post-procedural measurement or to a category 5 or 6.
Improved Rutherford Becker Clinical Category:
An improvement (a decrease) in the Rutherford Becker Clinical Category of at least one category from baseline and subsequently from the earliest post-procedural measurement."|Between baseline and 1 month|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.||Percentage of Limbs|Participants||Number
787635|NCT00844532|Secondary|Rutherford Becker Clinical Category for the Treated Limb(s)|"The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.
Category and Clinical Description:
0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable"|3 years|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.||Percentage of Limbs|Participants||Number
787636|NCT00844532|Secondary|Rutherford Becker Clinical Category for the Treated Limb(s)|"The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.
Category and Clinical Description:
0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable"|2 years|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.||Percentage of Limbs|Participants||Number
787637|NCT00844532|Secondary|Rutherford Becker Clinical Category for the Treated Limb(s)|"The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.
Category and Clinical Description:
0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable"|9 months|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.||Percentage of Limbs|Participants||Number
787638|NCT00844532|Secondary|Rutherford Becker Clinical Category for the Treated Limb(s)|"The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.
Category and Clinical Description:
0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable"|1 month|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.||Percentage of Limbs|Participants||Number
787639|NCT00844532|Secondary|Rutherford Becker Clinical Category for the Treated Limb(s)|"The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.
Category and Clinical Description:
0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable"|Pre-Procedure|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.||Percentage of Limbs|Participants||Number
787640|NCT00844532|Secondary|Walking Impairment Questionaire Scores|Measured by the Walking Impairment Questionnaire (WIQ)|3 years|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.The highest score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.||scores on a scale||Standard Deviation|Mean
787641|NCT00844532|Secondary|Walking Impairment Questionaire Scores|Measured by the Walking Impairment Questionnaire (WIQ)|2 years|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.The highest score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.||scores on a scale||Standard Deviation|Mean
787642|NCT00844532|Secondary|Walking Impairment Questionaire Scores|Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best).|9 months|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point. The highest score for each domain is 100%, which indicates no difficulty.Lowest possible score for each domain is 0%, which indicates inability to perform the activity.||scores on a scale||Standard Deviation|Mean
787643|NCT00844532|Secondary|Walking Impairment Questionaire Scores|Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best).|1 month|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.The highest score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.||scores on a scale||Standard Deviation|Mean
787660|NCT00844545|Secondary|Pharmacokinetics (PK) and Pharmacodynamics (PD); Minimum and Maximum Blood Concentration||Induction Phase for 4 weeks followed by Maintenance Phase starting on Week 5 through 26 weeks or longer.|PK parameters Cmin and Cmax were estimated using a population PK model developed from the observed PK concentration data||micrograms/mil||Standard Deviation|Mean
788090|NCT00855595|Secondary|Number of Inflammatory Lesions at Weeks 2, 4, 6, 8 and 12 (LOCF)||Week 2, 4, 6, 8 and 12|FAS||Inflammatory lesions||Standard Deviation|Mean
787644|NCT00844532|Secondary|Walking Impairment Questionaire Scores|Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best).|Pre-procedure|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.||score on a scale||Standard Deviation|Mean
787645|NCT00844532|Secondary|Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)|The changes in thigh brachial index is the ratio of change between the pre-procedure measure and the stated timepoint measure.|3 years|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.||Ratio|Participants|Standard Deviation|Mean
787646|NCT00844532|Secondary|Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)|The changes in thigh brachial index is the ratio of change between the pre-procedure measure and the stated timepoint measure.|2 years|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.||Ratio|Participants|Standard Deviation|Mean
787647|NCT00844532|Secondary|Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)|The changes in thigh brachial index is the ratio of change between the pre-procedure measure and the stated timepoint measure.|9 months|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.||Ratio|Participants|Standard Deviation|Mean
787648|NCT00844532|Secondary|Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)|The changes in thigh brachial index is the ratio of change between the pre-procedure measure and the stated timepoint measure.|1 month|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.||Ratio|Participants|Standard Deviation|Mean
787649|NCT00844532|Secondary|Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)|The changes in thigh brachial index is the ratio of change between the pre-procedure measure and the stated timepoint measure.|Post-procedure|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.||Ratio|Participants|Standard Deviation|Mean
787650|NCT00844532|Secondary|Thigh Brachial Index (TBI) for the Treated Limb(s)|The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.|3 years|Per target limb analysis. ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.||Ratio|Participants|Standard Deviation|Mean
787651|NCT00844532|Secondary|Thigh Brachial Index (TBI) for the Treated Limb(s)|The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.|2 years|Per target limb analysis. ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.||Ratio|Participants|Standard Deviation|Mean
787652|NCT00844532|Secondary|Thigh Brachial Index (TBI) for the Treated Limb(s)|The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.|9 months|Per target limb analysis. ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.||Ratio|Participants|Standard Deviation|Mean
787653|NCT00844532|Secondary|Thigh Brachial Index (TBI) for the Treated Limb(s)|The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.|1 month|Per target limb analysis.ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.||Ratio|Participants|Standard Deviation|Mean
787654|NCT00844532|Secondary|Thigh Brachial Index (TBI) for the Treated Limb(s)|The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.|Post-procedure|Per target limb analysis. ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.||Ratio|Participants|Standard Deviation|Mean
787655|NCT00844532|Secondary|Thigh Brachial Index (TBI) for the Treated Limb(s)|The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.|Pre-procedure|Per target limb analysis. ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.||Ratio|Participants|Standard Deviation|Mean
787656|NCT00844532|Secondary|Procedure Success|Procedure success is defined, per patient basis, as technical success without any of the following complications; death due to all causes, myocardial infarction (MI), major amputation of the treated limb(s), stent thrombosis and target lesion revascularization (TLR) within two (2) days after the index procedure or at hospital discharge, whichever is sooner.|Beginning of index procedure to 2 days post-index procedure or discharge, whichever is sooner|ITT population||percentage of participants||95% Confidence Interval|Number
787657|NCT00844532|Secondary|Technical Success|Technical success is defined, on per target lesion basis, device success and attainment of a final in-stent residual stenosis of < 30% by QA or as reported by the investigator, if QA is not available.|acute: from beginning of index procedure to end of index procedure.|ITT population||percentage of target lesions|Participants|95% Confidence Interval|Number
787658|NCT00844532|Secondary|Device Success|On a per device basis, the achievement of successful delivery and deployment of the trial device(s) at the intended location(s) and successful withdrawal of the delivery catheter(s).|acute: from beginning of index procedure to end of index procedure.|Intent to treat (ITT) population. Included 192 study stents implanted plus 1 study stent inserted in subjects vasculature, but not implanted due to device malfunction. 1 study stent was excluded from device success because the chosen size was not appropriate, therefore the stent was not implanted.||percentage of devices|Participants|95% Confidence Interval|Number
787661|NCT00844545|Secondary|TMA Intervention Rate|TMA Intervention Rate (# PE/PI and # Dialysis Events/Patient/Day) in the eculizumab treatment period (from baseline through end of the study) for PE/PI and (from the fifteenth day following the first eculizumab dose through end of the study) for new dialysis events was compared with the TMA Intervention Rate during the pre-eculizumab treatment period.|Through End of Study, Median Exposure 100.29 Weeks|A signed rank test assessed differences in magnitudes of change in TMA intervention rate between the pre-eculizumab treatment period and during eculizumab treatment period for ITT population.||# events/patient/day||Standard Deviation|Mean
787662|NCT00844545|Secondary|Percentage of Patients With Complete TMA Response|The proportion of patients who achieved a Complete TMA Response from baseline through end of the study was determined. Complete TMA Response was defined as Hematologic Normalization plus improvement in renal function (defined as ≥25% reduction from baseline in serum creatinine), which was sustained for two consecutive measurements over a period of at least four weeks.|Through End of Study, Median Exposure 100.29 Weeks|Tabulations of the proportion of patients who achieved a complete TMA response from baseline through end of study were performed. For this endpoint, for any relevant proportions, exact binomial confidence intervals were produced.||Percentage of Participants||95% Confidence Interval|Number
787663|NCT00844545|Secondary|Percentage of Patients With Hematologic Normalization|Hematologic Normalization was defined as normalization of both platelet count and lactic dehydrogenase (LDH) sustained for at least two consecutive measurements which spanned a period of at least four weeks.|Through End of Study, Median Exposure 100.29 Weeks|Tabulations of the proportion of patients who achieved a hematologic normalization through end of study were performed for the ITT population. Exact binomial confidence intervals were produced for the analysis.||Percentage of Participants||95% Confidence Interval|Number
787664|NCT00844545|Secondary|Percentage of Patients With Platelet Count Normalization|Platelet Count Normalization was defined as the platelet count observed to be ≥150 x 10^9/L on at least two consecutive measurements which span a period of at least four weeks.|Through End of Study, Median Exposure 100.29 Weeks|The Tabulations of the proportion of patients who achieved platelet count normalization through end of the study were performed for the ITT population. Exact binomial confidence intervals were produced for the analysis.||Percentage of Participants||95% Confidence Interval|Number
787665|NCT00844545|Secondary|Platelet Count Change From Baseline to 156 Weeks||From Baseline to 156 Weeks|Change from baseline platelet counts were analyzed for the ITT population using a repeated measurement ANOVA model. A least squares (LS) mean for the change from baseline was produced for each study day for which a measurement of platelet count was scheduled. Significance of change was assessed at the 5% level at each time point.||10^9 cells/L||95% Confidence Interval|Least Squares Mean
787666|NCT00844545|Secondary|TMA Intervention Rate|TMA Intervention Rate (# PE/PI and # Dialysis Events/Patient/Day) in the eculizumab treatment period (from baseline through 26 weeks) for PE/PI and (from the fifteenth day following the first eculizumab dose through 26 weeks) for new dialysis events was compared with the TMA Intervention Rate during the pre-eculizumab treatment period.|Through 26 weeks|A signed rank test assessed differences in magnitudes of change in TMA intervention rate between the pre-eculizumab treatment period and during eculizumab treatment period for ITT population.||# events/patient/day||Standard Deviation|Mean
787667|NCT00844545|Secondary|Percentage of Patients With Complete TMA Response|The proportion of patients who achieved a Complete TMA Response from baseline through 26 weeks of treatment with eculizumab was determined. Complete TMA Response was defined as Hematologic Normalization plus improvement in renal function (defined as as ≥25% reduction from baseline in serum creatinine), which was sustained for two consecutive measurements over a period of at least four weeks.|Through 26 weeks|Tabulations of the proportion of patients who achieved a complete TMA response from baseline through 26 weeks were performed. For this endpoint, for any relevant proportions, exact binomial confidence intervals were produced.||Percentage of Participants||95% Confidence Interval|Number
787668|NCT00844545|Primary|Percentage of Patients With Hematologic Normalization|Hematologic Normalization was defined as normalization of both platelet count and lactic dehydrogenase (LDH) sustained for at least two consecutive measurements which spanned a period of at least four weeks.|Through 26 weeks|Tabulations of the proportion of patients who achieved a hematologic normalization through 26 weeks were performed for the ITT population. Exact binomial confidence intervals were produced for the analysis.||Percentage of Participants||95% Confidence Interval|Number
787669|NCT00844545|Primary|Percentage of Patients With Platelet Count Normalization|The primary objective of the study (per protocol) was to assess the effect of eculizumab to reduce TMA as measured by platelet count change from baseline (BL) during the Treatment Period (26 weeks) in patients with plasma therapy (PT)-resistant aHUS (protocol defined), including assessment of the proportion of patients who achieved Platelet Count Normalization from baseline through 26 weeks. Platelet Count Normalization was defined as the platelet count observed to be ≥150 x 10^9/L on at least two consecutive measurements which span a period of at least four weeks.|Through 26 weeks|The Tabulations of the proportion of patients who achieved platelet count normalization through 26 weeks were performed for the ITT population. Exact binomial confidence intervals were produced for the analysis.||Percentage of Participants||95% Confidence Interval|Number
787670|NCT00844545|Primary|Platelet Count Change From Baseline to 26 Weeks||From Baseline to 26 weeks|Change from baseline platelet counts were analyzed for the ITT population using a repeated measurement ANOVA model. A least squares (LS) mean for the change from baseline was produced for each study day for which a measurement of platelet count was scheduled. Significance of change was assessed at the 5% level at each time point.||10^9 cells/L||95% Confidence Interval|Least Squares Mean
787671|NCT00844558|Secondary|Change in Chair Stand Time|Measured as the total time (in seconds) required to stand five times from a seated position in a standardized chair without using arms.|0,3,6,and 12 months|||seconds||95% Confidence Interval|Mean
787672|NCT00844558|Secondary|Change in Stair Climb Time, Secs|Functional limitations specific to ascending stairs were assessed with a times stair climb, using a standard eight-stair flight (stair height = 19 cm)|0,3,6, and 12 months|||seconds||95% Confidence Interval|Mean
787673|NCT00844558|Secondary|Change in Long Distance Corridor Walk (LDCW) Time, Secs|The LDCW included both 2-min walk distance and 400-m walk time. This measure has been shown to be predictive of changes in community mobility. Per the LDCW protocol, for participants unable to walk 400 m, gait speed was estimated from the 2-min walk distance, so that all participant data were on the same scale.|0,3,6 and 12 months|||seconds||95% Confidence Interval|Mean
787674|NCT00844558|Secondary|Change in KOOS Symptoms|"This instrument has been found to be a reliable and responsive measure in older adults with knee OA as well as sensitive to changes in pain and knee-related symptoms over 6- and 12-mo periods.
Scored from 0 to 100 with 100 indicating no symptoms."|0,3,6 and 12 months|||units on a scale||95% Confidence Interval|Mean
787675|NCT00844558|Secondary|Change in Knee Osteoarthritis Injury and Outcome Scale (KOOS) Pain|"This is a 42-item self-administered questionnaire that covers five patient-relevant dimensions, including pain and knee-related symptoms. This instrument has been found to be a reliable and responsive measure in older adults with knee OA as well as sensitive to changes in pain and knee-related symptoms over 6- and 12-mo periods.
Scored from 0 to 100 with 100 indicating no pain."|0,3,6 and 12 months|||units on a scale||95% Confidence Interval|Mean
787676|NCT00844558|Primary|Change in Basic Lower Limb Function (Late Life Function Index) Late Life Function and Disability Instrument|"This is a questionnaire that evaluates self-reported difficulty in a person's ability to do discrete actions or activities primarily involving standing, stooping and fundamental walking activities without the help of others. Factors that may influence difficulty in task performance include pain, fatigue, fear, weakness, soreness, ailments, health conditions and disabilities.
Scored from 14 to 70 with scores approaching 70 signifying high levels in ability to perform activities primarily involving standing, stooping, and fundamental walking (without assistance), and scores approaching 14 signifying low levels in ability to perform activities primarily involving standing, stooping, and fundamental walking (without assistance)."|0,3,6, and 12 months|||units on a scale||95% Confidence Interval|Mean
787677|NCT00844597|Post-Hoc|Adverse Events >15%|Adverse events that occurred in >15% of overall patient population across dose level arms.|27 Weeks|Safety Population||Events|||Number
787678|NCT00844597|Primary|Treatment Emergent Adverse Events|Number of Patients with Treatment Emergent Adverse Events|from Baseline to Follow up (27 weeks)|Safety Population||participants|||Number
787679|NCT00844597|Secondary|Efficacy of Eteplirsen Over 12 Weeks of Dosing|Efficacy was defined as an estimated change in the percentage of dystrophin positive fibers (assessed by IHC) at Week 14 from Baseline after 12 weekly doses of eterplirsen. This outcome measure represents the number of patients to show an increase in the percentage of dystrophin-positive fibers.|Biopsies were taken at Baseline and Week 14|Per Protocol Population - Included all patients who received all 12 doses of study treatment.||participants|||Number
787680|NCT00844597|Secondary|Pharmacokinetics - Mean Peak Plasma Concentration of AVI-4658 After Administration|Standard Pharmacokinetic parameters estimated using non-compartmental modeling of plasma concentration data.|Samples were taken: 30 minutes pre dose; and at 5 (±1), 15 (±2), 30 (±5), 60 (±5), and 90 (±5) minutes; and 2, 4, 6, 8, 12, and 24 hours (all ± 15 minutes) post dose at Weeks 1, 6, and 12|PK Evaluable Population: Included all patients who provided at least 1 PK sample. The reportable PK population included those patients with at least Cmax, Tmax, and AUC0-24 computed from 1 or more of the 3 sampling days (1st, 6th, 12th dose [Weeks 1, 6, and 12]).||ng/mL||Standard Deviation|Mean
787681|NCT00844597|Primary|Safety and Tolerability|Number of subjects with 1 or more Treatment Emergent Adverse Event that are possibly related to the investigational drug|Baseline to 6 months|Safety Population - Any patient who received at least one dose of the study drug.||participants|||Number
787682|NCT00844649|Other Pre-specified|Number of Participants With Dose Delays/Doses Not Given|The number of dose delays or doses not given experienced by participants during the treatment period. Dose delays are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities. Treatment delays of no longer than 21 days allowed participants to recover from acute toxicity, otherwise participants were discontinued from further treatment except in the event of peripheral neuropathy.|Up to 666 days|Treated Population||number of dose delays|||Number
787683|NCT00844649|Other Pre-specified|Number of Participants With Dose Interruptions|The number of participants with dose interruptions experienced by participants that occurred during the treatment period. Dose interruptions are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities.|Maximum time on treatment was 666 days|Safety population, includes participants who received at least one study treatment||participants|||Number
787684|NCT00844649|Other Pre-specified|Number of Participants With Dose Reductions|The number of participants with dose reductions occurring during the treatment period. Dose reductions are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities.|Maximum time on treatment was 666 days|Treated Population||participants|||Number
787685|NCT00844649|Other Pre-specified|Participants With Treatment Emergent Adverse Events (AE)|A Treatment Emergent Adverse Event (TEAE) is as any AE occurring or worsening on or after the first treatment of any study drug, and within 30 days after the last dose of the last study drug. Severity grades according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE) on a 1-5 scale: Grade 1= Mild AE, Grade 2= Moderate AE, Grade 3= Severe AE, Grade 4= Life-threatening or disabling AE, Grade 5=Death related to AE.|Study drug initiation through 30 days after the last dose of study drug or EOS, whichever is later; Up to 696 days|Treated patient population||participants|||Number
787686|NCT00844649|Secondary|Percentage of Participants Who Achieved an Objective Confirmed Overall Response by Independent Radiological Review (IRR)|Objective tumor response was summarized as the percentage of participants who achieved a confirmed complete (CR) or partial response (PR) based on an independent blinded radiology assessment of response using Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. Using RECIST Version 1.0, participants were to achieve either a complete response (CR) defined as the disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation or partial response (PR) defined as at least a 30% decrease in the sum of the longest diameters of target lesions and no progression in non-target lesions based on confirmed responses from the investigator assessment of best overall response during study treatment.|Assessment every 4 weeks after initial response; Day 1 to data cut off of 17 Sept 2013; maximum time on study 37 months|Intent to Treat population (ITT population) consisted of all randomized participants.||percentage of participants||95% Confidence Interval|Number
787687|NCT00844649|Secondary|Progression-free Survival (PFS) by Independent Radiological Review (IRR)|Progression-free survival was defined as the time from the date of randomization to the date of disease progression, or death (any cause) on or prior to the clinical cutoff date, whichever occurred earlier. Participants who did not have disease progression or had not died were censored at the date of the last tumor assessment, on or prior to the clinical cutoff, and the patient was progression free. If a patient began a new anti-cancer treatment prior to documented disease progression (or death), the patient was censored at the date of last assessment when the patient was documented as progression free prior to the intervention. Patients with two or more consecutive missing response assessments prior to a visit with documented progression (or death) were censored at the last date of tumor assessment when the patient was documented to be progression free. PFS was summarized using Kaplan-Meier methods.|Randomization until disease progression or death from any cause; Until the data cut off of 17 Sept 2012. The maximum time in follow up was 37 months.|Intent to Treat population (ITT population) consisted of all randomized participants.||months||95% Confidence Interval|Median
787688|NCT00844649|Primary|Overall Survival (OS)|Overall survival was defined as the time from the date of randomization to the date of death from all causes. Participants who did not die were censored at the last known time the participant was alive. Patient survival was summarized using Kaplan-Meier methods.|From randomization to death; until the data cut off 17 Sept 2012. The maximum time in follow up was 37 months.|Intent to Treat population (ITT population) consisted of all randomized participants.||months||95% Confidence Interval|Median
787689|NCT00844714|Primary|Flow-mediated Vasodilation (FMD)|endothelial function as assessed by flow-mediated vasodilation of the brachial artery|12 weeks, 24 weeks|||percentage change in diameter||Inter-Quartile Range|Median
787690|NCT00844753|Primary|Percentage of Participants Who Were Autism Spectrum Disorder Respondents|"Respondents were defined as having ≥30% decrease on the HSQ and CGI-I≤2). The 25-item HSQ was adapted by the Research Units on Pediatric Psychopharmacology Autism Network to evaluate behavioral noncompliance in children with autism spectrum disorder (ASD). The Home Situations Questionnaire – Pervasive Developmental Disorder (HSQ) is a 25-item parent rating scale assessing noncompliance. Parents are asked to indicate whether each item is a problem and, if so, its severity from 1 (mild) to 9 (severe). The School Situations Questionnaire (SSQ) is a 9-item teacher rating scale that assesses noncompliance. The SSQ is a companion instrument to the HSQ and uses the same rating scale.
The Clinical Global Impressions Scale (CGI) includes subscales for severity of illness and global improvement. The Severity scale is scored from 1 (normal) to 7 (extremely ill),"|week 10|||percentage of participants|||Number
787691|NCT00844753|Primary|Percentage of Participants Who Were Attention Deficit Hyperactivity Disorder (ADHD) Respondents|Respondents were defined as having ≥30% decrease on the SNAP and CGI-I<=2). The Swanson, Nolan, and Pelham (SNAP)–IV Parent and Teacher Rating Scales were used to measure ADHD and oppositional symptoms at home and school. The SNAP-IV ADHD section contains items for each of the 18 Diagnostic and Statistical Manual of Mental Disorders-IV symptoms of ADHD rated from 0 (not at all) to 3 (very much). The Clinical Global Impressions Scale (CGI) includes subscales for severity of illness and global improvement. The Severity scale is scored from 1 (normal) to 7 (extremely ill), with a rating of ≥4 required for inclusion. The Improvement score ranged from 1 (very much improved) through 4 (no change) to 7 (very much worse). The CGI was completed by a blinded rater based on parent/child interview and review of completed parent and school behavior problem questionnaires at each study visit.|week 10|||percentage of participants|||Number
787692|NCT00844805|Secondary|Percentage of Participants That Achieved ASAS-20 Response at Week 28 in the Treatment Phase|"ASAS-20 response was defined as ≥20% improvement in response according to following criteria:
• An improvement of ≥20% from baseline and an absolute improvement from
baseline of ≥10 mm in at least 3 of the following 4 domains (patient global assessment, pain, function,and inflammation)
• Absence of deterioration from baseline (≥20% and an absolute change of
≥10 mm) in the potential remaining domain."|Week 28|The Intent-to-Treat Population consisted of all participants who were randomized, took at least one dose of study medication, and had at least one post-baseline efficacy assessment.||Percentage of Participants|||Number
787693|NCT00844805|Secondary|Percentage of Participants That Achieved ASAS-40 Response at Week 28 in the Treatment Phase|ASAS domains were measured on a VAS of 0 to 100 mm (with 0 being the very best situation and 100 being the very worse situation). ASAS-40 response was defined as ASAS achieving ≥40% improvement in 3 of the 4 domains (patient global assessment, total back pain, function, and inflammation), with an absolute improvement of ≥20 mm and no deterioration in the remaining domain.|Week 28|The Intent-to-Treat Population consisted of all participants who were randomized, took at least one dose of study medication, and had at least one post-baseline efficacy assessment.||Percentage of Participants|||Number
787694|NCT00844805|Secondary|Number of Participants Who Achieved ASAS Partial Remission That Experienced Disease Flare With Naproxen Maintenance Treatment in the Follow-Up Phase|"The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) employs a VAS of 0mm (best) to 100mm (worst). Disease flare was defined as reaching a BASDAI of ≥30 mm during two consecutive visits after Week 28 until Week 52.
ASAS domains were measured on a VAS of 0 to 100 mm (with 0 being the very best situation and 100 being the very worse situation). ASAS partial remission criteria was defined as reaching ≤20 mm in all 4 ASAS domains (i.e., patient global assessment, total back pain, function, and inflammation)."|Week 52|The Intent-to-Treat Population consisted of all subjects who were randomized, took at least one dose of study medication, and had at least one post-baseline efficacy assessment.||Participants|||Number
787695|NCT00844805|Secondary|Median Duration of Maintaining ASAS Partial Remission in the Follow-Up Phase|ASAS domains were measured on a VAS of 0 to 100 mm (with 0 being the very best situation and 100 being the very worse situation). ASAS partial remission criteria is defined as reaching ≤20 mm in all 4 ASAS domains (i.e., patient global assessment, total back pain, function, and inflammation).|Week 52|The Intent-to-Treat Population consisted of all participants who were randomized to treatment, took at least one dose of study medication, and had at least one post-baseline efficacy assessment.||Weeks||Full Range|Median
787789|NCT00845663|Secondary|Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Swelling|Categorized answer ranges from not at all to extremely.|Immediately after injection, 1 hour and 24 hours after injection|Intent-to-treat population||Participants|||Number
787790|NCT00845663|Secondary|Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Redness|Categorized answer ranges from not at all to extremely.|Immediately after injection, 1 hour and 24 hours after injection|Intent-to-treat population||Participants|||Number
787696|NCT00844805|Secondary|Number of Participants With Complete Absence of Active Inflammatory Lesions at the Spine and Sacroiliac Joint at Treatment Week 52|"MRI scans (T1 for chronic changes and STIR for active changes) of the whole spine was performed to determine the Berlin MRI Spine Score. The Berlin MRI scoring for the spine was assessed on a scale of 0 (best) to 3 (worst) for a maximum total score of 69, with 0 = no inflammatory lesions; 1 = minor bone marrow edema; 2 = moderate bone marrow edema; 3 = major bone marrow edema; or N = non readable. Complete absence of active spinal inflammatory lesions was defined as a Berlin MRI Score = 0.
Each sacroiliac joint was divided into four quadrants. An activity score of 0 (best) to 3 (worst) was assessed for every quadrant of the left and right sacroiliac joint separately for a total maximum score of 24, with with 0 = no inflammatory lesions; 1 = minor bone marrow edema; 2 = moderate bone marrow edema; 3 = major bone marrow edema; or N = non readable. Complete absence of active sacroiliac inflammatory lesions was defined as a Score = 0."|Week 52|The Intent-to-Treat Population consisted of all participants who were randomized, took at least one dose of study medication, and had at least one post-baseline efficacy assessment.||Participants|||Number
787697|NCT00844805|Secondary|Number of Participants With Complete Absence of Active Inflammatory Lesions at the Sacroiliac Joint at Treatment Week 52|EaEach sacroiliac joint was divided into four quadrants. An activity score of 0 (best) to 3 (worst) was assessed for every quadrant of the left and right sacroiliac joint separately for a total maximum score of 24, with with 0 = no inflammatory lesions; 1 = minor bone marrow edema; 2 = moderate bone marrow edema; 3 = major bone marrow edema; or N = non readable. Complete absence of active sacroiliac inflammatory lesions was defined as a Score = 0.|Week 52|The Intent-to-Treat Population consisted of all participants who were randomized, took at least one dose of study medication, and had at least one post-baseline efficacy assessment.||Participants|||Number
787698|NCT00844805|Secondary|Number of Participants With Complete Absence of Active Inflammatory Lesions at the Spine at Treatment Week 52|MRI scans (T1 for chronic changes and STIR for active changes) of the whole spine was performed to determine the Berlin MRI Spine Score. The Berlin MRI scoring for the spine was assessed on a scale of 0 (best) to 3 (worst) for a maximum total score of 69, with 0 = no inflammatory lesions; 1 = minor bone marrow edema; 2 = moderate bone marrow edema; 3 = major bone marrow edema; or N = non readable. Complete absence of active inflammatory lesions was defined as a Berlin MRI Score = 0.|Week 52|The Intent-to-Treat Population consisted of all participants that were randomized, took at least one dose of study medication, and had at least one post-baseline efficacy assessment.||Participants|||Number
787699|NCT00844805|Secondary|Number of Participants With Complete Absence of Active Inflammatory Lesions at the Spine and Sacroiliac Joint at Treatment Week 28|"MRI scans (T1 for chronic changes and STIR for active changes) of the whole spine was performed to determine the Berlin MRI Spine Score. The Berlin MRI scoring for the spine was assessed on a scale of 0 (best) to 3 (worst) for a maximum total score of 69, with 0 = no inflammatory lesions; 1 = minor bone marrow edema; 2 = moderate bone marrow edema; 3 = major bone marrow edema; or N = non readable. Complete absence of active inflammatory lesions was defined as a Berlin MRI Score = 0.
Each sacroiliac joint was divided into four quadrants. An activity score of 0 (best) to 3 (worst) was assessed for every quadrant of the left and right sacroiliac joint separately for a total maximum score of 24, with with 0 = no inflammatory lesions; 1 = minor bone marrow edema; 2 = moderate bone marrow edema; 3 = major bone marrow edema; or N = non readable. Complete absence of active sacroiliac inflammatory lesions was defined as a Score = 0."|Week 28|The Intent-to-Treat Population consisted of all participants who were randomized, took at least one dose of study medication, and had at least one post-baseline efficacy assessment.||Participants|||Number
787700|NCT00844805|Secondary|Number of Participants With Complete Absence of Active Inflammatory Lesions at the Sacroiliac Joint at Treatment Week 28|Each sacroiliac joint was divided into four quadrants. An activity score of 0 (best) to 3 (worst) was assessed for every quadrant of the left and right sacroiliac joint separately for a total maximum score of 24, with with 0 = no inflammatory lesions; 1 = minor bone marrow edema; 2 = moderate bone marrow edema; 3 = major bone marrow edema; or N = non readable. Complete absence of active inflammatory lesions at the sacroiliac joints was defined as a Score = 0.|Week 28|The Intent-to-Treat Population consisted of all participants who were randomized, took at least one dose of study medication, and had at least one post-baseline efficacy assessment.||Participants|||Number
787701|NCT00844805|Secondary|Number of Participants With Complete Absence of Active Inflammatory Lesions at the Spine at Treatment Week 28|MRI scans (T1 for chronic changes and STIR for active changes) of the whole spine was performed to determine the Berlin MRI Spine Score. The Berlin MRI scoring for the spine was assessed on a scale of 0 (best) to 3 (worst) for a maximum total score of 69, with 0 = no inflammatory lesions; 1 = minor bone marrow edema; 2 = moderate bone marrow edema; 3 = major bone marrow edema; or N = non readable. Complete absence of active inflammatory lesions was defined as a Berlin MRI Score = 0.|Week 28|The Intent-to-Treat Population consisted of all participants who were randomized, took at least one dose of study medication, and had at least one post-baseline efficacy assessment.||Participants|||Number
787702|NCT00844805|Secondary|Change From Baseline in the Sacroiliac Overall Score at Week 52|Each sacroiliac joint was divided into four quadrants. An activity score of 0 (best) to 3 (worst) was assessed for every quadrant of the left and right sacroiliac joint separately for a total maximum score of 24, with with 0 = no inflammatory lesions; 1 = minor bone marrow edema; 2 = moderate bone marrow edema; 3 = major bone marrow edema; or N = non readable.|Baseline, Week 28|The number of participants represented those with a screening value and a value at treatment Week 28.||Units on a Scale||Inter-Quartile Range|Median
787703|NCT00844805|Secondary|Change From Baseline of Berlin MRI Spine Overall Score at Week 52|MRI scans (T1 for chronic changes and STIR for active changes) of the whole spine was performed to determine the Berlin MRI Spine Score. The Berlin MRI scoring for the spine was assessed on a scale of 0 (best) to 3 (worst) for a maximum total score of 69, with 0 = no inflammatory lesions; 1 = minor bone marrow edema; 2 = moderate bone marrow edema; 3 = major bone marrow edema; or N = non readable.|Baseline, Week 52|The number of participants represents those with a Week 28 values and those with a Week 52 value.||Units on a Scale||Inter-Quartile Range|Median
787791|NCT00845663|Secondary|Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Itching|Categorized answer ranges from not at all to extremely.|Immediately after injection, 1 hour and 24 hours after injection|Intent-to-treat population||Participants|||Number
787792|NCT00845663|Secondary|Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Cold Sensation|Categorized answer ranges from not at all to extremely.|Immediately after injection, 1 hour and 24 hours after injection|Intent-to-treat population||Participants|||Number
787704|NCT00844805|Secondary|Change From Baseline in the Sacroiliac Overall Score at Week 28|Each sacroiliac joint was divided into four quadrants. An activity score of 0 (best) to 3 (worst) was assessed for every quadrant of the left and right sacroiliac joint separately for a total maximum score of 24, with with 0 = no inflammatory lesions; 1 = minor bone marrow edema; 2 = moderate bone marrow edema; 3 = major bone marrow edema; or N = non readable.|Baseline, Week 28|The number of participants represented those with a screening value and a value at treatment Week 28.||Units on a Scale||Inter-Quartile Range|Median
787705|NCT00844805|Secondary|Change From Baseline of Berlin Magnetic Resonance Imaging (MRI) Spine Overall Score at Week 28|MRI scans (T1 for chronic changes and short tau inversion recovery [STIR] for active changes) of the whole spine was performed to determine the Berlin MRI Spine Score. The Berlin MRI scoring for the spine was assessed on a scale of 0 (best) to 3 (worst) for a maximum total score of 69, with 0 = no inflammatory lesions; 1 = minor bone marrow edema; 2 = moderate bone marrow edema; 3 = major bone marrow edema; or N = non readable.|Baseline, Week 28|The number of participants represented those with a screening value and a value at treatment Week 28.||Units on a Scale||Inter-Quartile Range|Median
787706|NCT00844805|Secondary|Percentage of Participants Maintaining the ASAS Partial Remission Criteria at Week 52 By Treatment Assignment in the Treatment Phase|ASAS domains were measured on a VAS of 0 to 100 mm (with 0 being the very best situation and 100 being the very worst situation). ASAS partial remission criteria is defined as reaching ≤20 mm in all 4 ASAS domains (i.e., patient global assessment, total back pain, function, and inflammation).|Week 52|The Intent-to-Treat Population consisted of all participants who were randomized, took at least one dose of study medication, and had at least one post-baseline efficacy assessment.||Percentage of Participants|||Number
787707|NCT00844805|Secondary|Number of Participants Maintaining the ASAS Partial Remission Criteria at Week 52 By Treatment Assignment in the Follow-Up Phase|ASAS domains were measured on a VAS of 0 to 100 mm (with 0 being the very best situation and 100 being the very worst situation). ASAS partial remission criteria is defined as reaching ≤20 mm in all 4 ASAS domains (i.e., patient global assessment, total back pain, function, and inflammation).|Week 52|The Intent-to-Treat Population consisted of all participants who were randomized, took at least one dose of study medication, and had at least one post-baseline efficacy assessment.||Participants|||Number
787708|NCT00844805|Primary|Number of Participants Achieving the Assessment in Ankylosing Spondylitis (ASAS) Partial Remission Criteria at Week 28|ASAS domains were measured on a visual analog scale (VAS) of 0 to 100 mm (with 0 being the very best situation and 100 being the very worst situation). ASAS partial remission criteria is defined as reaching ≤20 mm in all 4 ASAS domains (i.e., patient global assessment, total back pain, function, and inflammation).|Week 28|The Intent-to-Treat Population consisted of all participants who were randomized, took at least one dose of study medication, and had at least one post-baseline efficacy assessment.||Participants|||Number
787709|NCT00844831|Secondary|Small Intestinal Bacterial Overgrowth (SIBO)|SIBO was measured before and after treatment.|28 days|||participants|||Number
787710|NCT00844831|Secondary|Small Bowel and Colon Transit Time by SmartPill® Transit Study||28 days|We were unable to obtain the smart pills for this section of the protocol.|||||
787711|NCT00844831|Primary|Presence of Small Intestinal Bacterial Overgrowth|Percent of patients with bacterial overgrowth before and after treatment.|28 days|ITT||Participants|||Count of Participants
787712|NCT00844844|Secondary|Pharmacokinetics (PK) and Pharmacodynamics (PD); Minimum and Maximum Blood Concentration||Induction Phase for 4 weeks followed by Maintenance Phase starting on Week 5 through 26 weeks or longer|PK parameters Cmin and Cmax were estimated using a population PK model developed from the observed PK concentration data||micrograms/mil||Standard Deviation|Mean
787713|NCT00844844|Secondary|TMA Intervention Rate|TMA Intervention Rate (# PE/PI and # Dialysis Events/Patient/Day) in the eculizumab treatment period (from baseline through end of the study) for PE/PI and (from the fifteenth day following the first eculizumab dose through end of the study) for new dialysis events was compared with the TMA Intervention Rate during the pre-eculizumab treatment period.|Through End of Study, Median Exposure 100.29 Weeks|A signed rank test assessed differences in magnitudes of change in TMA intervention rate between the pre-eculizumab treatment period and during eculizumab treatment period for ITT population.||# events/patient/day||Standard Deviation|Mean
787714|NCT00844844|Secondary|Percentage of Patients With Complete TMA Response|The proportion of patients who achieved a Complete TMA Response from baseline through end of the study was determined. Complete TMA Response was defined as Hematologic Normalization plus improvement in renal function (defined as ≥25% reduction from baseline in serum creatinine), which was sustained for two consecutive measurements over a period of at least four weeks.|Through End of Study, Median Exposure 100.29 Weeks|Tabulations of the proportion of patients who achieved a complete TMA response from baseline through end of study were performed. For this endpoint, for any relevant proportions, exact binomial confidence intervals were produced.||Percentage of Participants||95% Confidence Interval|Number
787715|NCT00844844|Secondary|Percentage of Patients With Hematologic Normalization|Hematologic Normalization was defined as normalization of both platelet count and lactic dehydrogenase (LDH) sustained for at least two consecutive measurements which spanned a period of at least four weeks.|Through End of Study, Median Exposure 100.29 Weeks|Tabulations of the proportion of patients who achieved a hematologic normalization through end of study were performed for the ITT population. Exact binomial confidence intervals were produced for the analysis.||Percentage of Participants||95% Confidence Interval|Number
787716|NCT00844844|Secondary|Percentage of Patients With Platelet Count Normalization|Platelet Count Normalization was defined as the platelet count observed to be ≥150 x 10^9/L on at least two consecutive measurements which span a period of at least four weeks.|Through End of Study, Median Exposure 100.29 Weeks|The Tabulations of the proportion of patients who achieved platelet count normalization through end of the study were performed for the ITT population. Exact binomial confidence intervals were produced for the analysis.||Percentage of Participants||95% Confidence Interval|Number
787717|NCT00844844|Secondary|Platelet Count Change From Baseline to 156 Weeks||From Baseline to 156 Weeks|Change from baseline platelet counts were analyzed for the ITT population using a repeated measurement ANOVA model. A least squares (LS) mean for the change from baseline was produced for each study day for which a measurement of platelet count was scheduled. Significance of change was assessed at the 5% level at each time point.||10^9 cells/L||95% Confidence Interval|Least Squares Mean
787718|NCT00844844|Secondary|TMA Intervention Rate|TMA Intervention Rate (# PE/PI and # Dialysis Events/Patient/Day) in the eculizumab treatment period (from baseline through 26 weeks) for PE/PI and (from the fifteenth day following the first eculizumab dose through 26 weeks) for new dialysis events was compared with the TMA Intervention Rate during the pre-eculizumab treatment period.|Through 26 weeks|A signed rank test assessed differences in magnitudes of change in TMA intervention rate between the pre-eculizumab treatment period and during eculizumab treatment period for ITT population.||# events/patient/day||Standard Deviation|Mean
787719|NCT00844844|Secondary|Percentage of Patients With Complete TMA Response|The proportion of patients who achieved a Complete TMA Response from baseline through 26 weeks of treatment with eculizumab was determined. Complete TMA Response was defined as Hematologic Normalization plus improvement in renal function (defined as ≥ 25% reduction from baseline in serum creatinine), which was sustained for two consecutive measurements over a period of at least four weeks.|Through 26 weeks|Tabulations of the proportion of patients who achieved a complete TMA response from baseline through 26 weeks were performed. For this endpoint, for any relevant proportions, exact binomial confidence intervals were produced.||Percentage of Participants||95% Confidence Interval|Number
787720|NCT00844844|Primary|Percentage of Patients With Hematologic Normalization|Hematologic Normalization was defined as normalization of both platelet count and lactic dehydrogenase (LDH) sustained for at least two consecutive measurements which spanned a period of at least four weeks.|Through 26 weeks|Tabulations of the proportion of patients who achieved a hematologic normalization through 26 weeks were performed for the ITT population. Exact binomial confidence intervals were produced for the analysis.||Percentage of Participants||95% Confidence Interval|Number
787721|NCT00844844|Primary|Percentage of Patients With Platelet Count Normalization|The primary objective of the study (per protocol) was to assess the effect of eculizumab to reduce TMA as measured by platelet count change from baseline (BL) during the Treatment Period (26 weeks) in patients with plasma therapy (PT)-resistant aHUS (protocol defined), including assessment of the proportion of patients who achieved Platelet Count Normalization from baseline through 26 weeks. Platelet Count Normalization was defined as the platelet count observed to be ≥150 x 10^9/L on at least two consecutive measurements which span a period of at least four weeks.|Through 26 weeks|The Tabulations of the proportion of patients who achieved platelet count normalization through 26 weeks were performed for the ITT population. Exact binomial confidence intervals were produced for the analysis.||Percentage of Participants||95% Confidence Interval|Number
787722|NCT00844844|Primary|Platelet Count Change From Baseline to 26 Weeks||From Baseline to 26 weeks|Change from baseline platelet counts were analyzed for the ITT population using a repeated measurement ANOVA model. A least squares (LS) mean for the change from baseline was produced for each study visit for which a measurement of platelet count was scheduled. Significance of change was assessed at the 5% level at each time point.||10^9 cells/L||95% Confidence Interval|Least Squares Mean
787723|NCT00844857|Other Pre-specified|Change From Baseline in Electrocardiogram (ECG) QTcF Interval Up to Week 8|QTcF is defined as ECG QT interval corrected for heart rate using the Fridericia correction factor.|Baseline, Week 8|Population analyzed M-ITT Population: all randomized participants who took at least 1 dose of study drug and excluding participants from 2 GCP noncompliant sites and QTcF at baseline and at least 1 post-baseline measurement; LOCF.||millisecond (msec)||Standard Error|Least Squares Mean
787724|NCT00844857|Other Pre-specified|Change From Baseline in Prolactin Up to Week 8|Prolactin LS mean was adjusted for baseline and treatment.|Baseline, Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug and excluding participants from 2 GCP noncompliant sites and prolactin at baseline and at least 1 post-baseline measurement; LOCF.||microgram/Liter (μg/L)||Standard Error|Least Squares Mean
787725|NCT00844857|Other Pre-specified|Change From Baseline in Alanine Aminotransferase/Serum Glutamic-Pyruvic Transaminase (ALT/SGPT) Up to Week 8|ALT/SGPT LS mean was adjusted for baseline and treatment.|Baseline, Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug and excluding participants from 2 GCP noncompliant sites and ALT/SGPT at baseline and at least 1 post-baseline measurement; LOCF.||units/Liter (U/L)||Standard Deviation|Least Squares Mean
787726|NCT00844857|Other Pre-specified|Change From Baseline in Fasting Metabolic Parameters Up to Week 8|Fasting glucose, fasting cholesterol and fasting triglycerides. LS means were adjusted for baseline and treatment.|Baseline, Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug excluding participants from 2 GCP noncompliant sites and fasting glucose, cholesterol and triglycerides at baseline and at least 1 post-baseline measurement; LOCF.||millimoles/liter (mmol/L)||Standard Error|Least Squares Mean
787727|NCT00844857|Other Pre-specified|Change From Baseline in Weight Up to Week 8|Weight LS mean was adjusted for baseline and treatment.|Baseline, Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug and excluding participants from 2 GCP noncompliant sites and weight at baseline and at least 1 post-baseline measurement; LOCF.||kilogram (kg)||Standard Error|Least Squares Mean
787728|NCT00844857|Other Pre-specified|Change From Baseline in the Quality of Life Questionnaire for Children and Adolescents (KINDL) Kid and Kiddo Combined Scale Up to Week 8|The KINDL consists of 24 Likert-scale items. Kid-KINDL was administered to ages 8-11 and Kiddo-KINDL to ages 12-16. Total scores were standardized to a 0 (lowest quality of life) to 100 (highest quality of life). LS mean was adjusted for baseline, country, and treatment.|Baseline, Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug excluding participants from 2 GCP noncompliant sites and had KINDL Kid and Kiddo results at baseline and at least 1 post-baseline measurement. Due to small number of 10- and 11-year olds results from the 2 versions were pooled; LOCF.||units on a scale||Standard Error|Least Squares Mean
787738|NCT00844857|Secondary|Change From Baseline in the YMRS Total Score at Week 8|The YMRS is an 11-item scale measuring the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total scores ranges: 0 to 60. LS mean was adjusted for baseline, country, treatment, visit, and treatment * visit interaction.|Baseline, Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug and excluding participants from 2 GCP noncompliant sites who had YMRS total scores with a baseline and at least 1 post-baseline measurement.||units on a scale||Standard Error|Least Squares Mean
787729|NCT00844857|Other Pre-specified|Percentage of Participants With at Least One Treatment-Emergent Incident of Dyskinesia Up to Week 8|Dyskinesia was measured using the Abnormal Involuntary Movement Scale (AIMS) a 12-item scale designed to record the occurrence of dyskinetic movements. Items 1 through 10 are rated on a 5-point scale: 0 (no dyskinetic movements) to 4 (severe dyskinetic movements). Items 11 and 12 are yes/no questions regarding the dental condition of a patient. Total score (0-40) is obtained by adding the scores of the first 10 items. An abnormal result is defined as having a score ≥3 for at least 1 of the first 7 items or a score ≥2 for at least two of the first 7 items.|Baseline, Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug and excluding participants from 2 GCP noncompliant sites; LOCF.||percentage of participants|||Number
787730|NCT00844857|Other Pre-specified|Percentage of Participants With at Least One Treatment-Emergent Incident of Parkinsonism Up to Week 8|Parkinsonism was measured using the Simpson-Angus Scale with a total scores range from 0 to 40. A score > 3 was considered abnormal. Simpson-Angus Scale consists of 10 items, each rated on a 5-point scale, 0 (complete absence of the condition) to 4 (presence of the condition in extreme form).|Baseline, Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug and excluding participants from 2 GCP noncompliant sites; LOCF.||percentage of participants|||Number
787731|NCT00844857|Secondary|Change From Baseline in the Quality of Life Questionnaire for Children and Adolescents (KINDL) Parent Scale Up to Week 8|The KINDL consists of 24 Likert-scale items. Total scores were standardized to a 0 (lowest quality of life) to 100 (highest quality of life). LS mean was adjusted for baseline, country, and treatment.|Baseline, Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug and excluding participants from 2 GCP noncompliant sites and KINDL Parent Scale at baseline and at least 1 post-baseline measurement; LOCF.||units on a scale||Standard Error|Least Squares Mean
787732|NCT00844857|Secondary|Change From Baseline in Symptoms of Attention-Deficit/Hyperactivity Disorder Up to Week 8|Attention Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version (ADHDRS-IV-PI): Investigator Administered and Scored measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Scores range: 0 to 54. The LS mean was adjusted for baseline and treatment.|Baseline up to Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug and excluding participants from 2 GCP noncompliant sites and ADHDRS-IV-PI results at baseline and at least 1 post-baseline measurement; LOCF.||units on a scale||Standard Error|Least Squares Mean
787733|NCT00844857|Secondary|Percentage of Participants With at Least One Incident of Worsening of Mania Up to Week 8|Worsening of mania was defined as YMRS score of ≥20 and a CGI severity of mania score of ≥ 5 at the same visit. The YMRS is an 11-item scale measuring severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe) with remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60. CGI measures severity of the participant's overall severity of bipolar symptoms and scores range from 1 (normal) to 7 (among the most extremely ill participants).|Baseline up to Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug and excluding participants from 2 GCP noncompliant sites with YMRS and CGI total scores at baseline and at least 1 post-baseline measurement; LOCF.||percentage of participants|||Number
787734|NCT00844857|Secondary|Percentage of Participants With Treatment Emergent Suicidal Ideation or Behavior Up to Week 8|"Columbia-Suicide Severity Rating Scale (C-SSRS) captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Percentage of participants with suicidal ideation, behavior, and acts are provided. Suicidal ideation: a yes answer to any 1 of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation. Suicidal behavior: a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal act: a yes answer to actual attempt or completed suicide."|Baseline up to Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug and excluding participants from 2 GCP noncompliant sites; LOCF.||percentage of participants|||Number
787735|NCT00844857|Secondary|Percentage of Participants With at Least One Treatment-Emergent Incident of Akathisia Up to Week 8|Akathisia was measured using the Barnes Akathisia Rating Scale where the global scores range from 0 (absent) to 5 (severe) and a score ≥ 2 is considered abnormal.|Baseline up to Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug excluding participants from 2 GCP noncompliant sites; LOCF.||percentage of participants|||Number
787736|NCT00844857|Secondary|Change From Baseline in the CDRS-R Total Score Up to Week 8|CDRS-R Total score measure the presence and severity of depression in children and consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. Rating of 1 indicates normal function. Total scores range from 17 to 113. In general, scores < 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. LS mean was adjusted for baseline, country, and treatment.|Baseline, Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug and excluding participants from 2 GCP noncompliant sites who had CDRS-R total scores at baseline and at least 1 post-baseline measurement; LOCF.||units on a scale||Standard Error|Least Squares Mean
787737|NCT00844857|Secondary|Change From Baseline in the Clinical Global Impression Scale - Bipolar Version (CGI-BP) Score at Week 8|CGI-BP measures severity of illness for bipolar illness. Scores range: 1 (normal, not ill at all) to 7 (among the most extremely ill patients). LS mean was adjusted for baseline, country, treatment, visit, and treatment * visit interaction.|Baseline, Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug and excluding participants from 2 GCP noncompliant sites and who had CGI-BP total scores at baseline and at least 1 post-baseline measurement.||units on a scale||Standard Error|Least Squares Mean
787793|NCT00845663|Secondary|Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Burning Sensation|Categorized answer ranges from not at all to extremely.|Immediately after injection, 1 hour and 24 hours after injection|Intent-to-treat population||Participants|||Number
787739|NCT00844857|Secondary|Percentage of Participants in Each Improvement Category Up to Week 8|CDRS-R scores: No/low improvement is < 25 percent (%) of maximum reduction from baseline. Mild improvement: maximum reduction from baseline on CDRS-R score ≥ 25% up to <50% and YMRS elevated mood score ≤ 2. Moderate improvement: maximum reduction from baseline on CDRS-R score ≥50% and <75% and YMRS elevated mood score ≤ 2. Major improvement: maximum reduction from baseline on CDRS-R score ≥75% and YMRS elevated mood score ≤ 2. CDRS-R measures presence/severity of depression in children. Scale is 17 items scored 1-to-5- or 1-to-7. Rating of 1 indicates normal function. Scores range: 17 to 113. Scores < 20 absence of depression, scores 20 to 30 borderline depression, scores 40 to 60 indicate moderate depression. YMRS is an 11-item scale that measures severity of manic episodes. Four items rated 0 (symptoms not present) to 8 (symptom extremely severe). Remaining items rated 0 (symptoms not present) to 4 (symptom extremely severe). Score range: 0 to 60.|Baseline up to Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug and excluding participants from 2 GCP noncompliant sites and who had both CDRS-R and YMRS total scores with a baseline and at least 1 post-baseline measurement; LOCF.||percentage of participants|||Number
787740|NCT00844857|Secondary|Percentage of Participants With Response Up to Week 8|Response is defined as a CDRS-R total score greater than or equal to (≥)50% reduction from baseline and YMRS elevated mood score ≤2. CDRS-R Total score measure the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. Rating of 1 indicates normal function. Scores range: 17 to 113. In general, <20 indicate an absence of depression, scores 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptoms not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptoms not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.|Baseline up to Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug and excluding participants from 2 GCP noncompliant sites and who had all of CDRS-R and YMRS total scores at baseline and at least 1 post-baseline measurement; LOCF||percentage of participants|||Number
787741|NCT00844857|Secondary|Percentage of Participants With Remission Up to Week 8|Remission is defined as a CDRS-R total score less than or equal to (≤)28, and Young Mania Rating Scale (YMRS) total score ≤ 8 and Clinical Global Impressions-Bipolar Version (CGI-BP) total score ≤3. CDRS-R is a 17-item scale measuring presence/severity of depression in children and is scored on a 1-to-5- or 1-to-7-point scale. Rating of 1 indicates normal function. Scores range: 17 to 113. Scores <20 indicate an absence of depression, scores 20 to 30 indicate borderline depression, scores 40 to 60 indicate moderate depression. The YMRS is an 11-item scale measuring severity of manic episodes; 4 items are rated on a scale from 0 (symptoms not present) to 8 (symptom extremely severe) with remaining items rated on a scale from 0 (symptoms not present) to 4 (symptom extremely severe). YMRS score ranges from 0 to 60. CGI-BP measures participant's overall severity of bipolar symptoms. Scores range: 1 (normal, not at all ill ) to 7 (among the most extremely ill participants).|Baseline up to Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug and excluding participants from 2 GCP noncompliant sites and who had both the CDRS-R, YMRS and CGI-BP total scores at baseline and at least 1 post-baseline measurement; Last Observation Carried Forward (LOCF)||percentage of participants|||Number
787742|NCT00844857|Primary|Change From Baseline in the Children's Depression Rating Scale Revised (CDRS-R) Total Score at Week 8|CDRS-R Total score measures the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. Least Square (LS) mean was adjusted for baseline, country, treatment, visit, and treatment times (*) visit interaction.|Baseline, Week 8|Population analyzed was the Modified Intention-to-Treat (M-ITT) Population: defined as all randomized participants who took at least 1 dose of study drug and excluding participants from 2 Good Clinical Practice (GCP) noncompliant sites and who had a baseline and at least 1 post-baseline CDRS-R measurement.||units on a scale||Standard Error|Least Squares Mean
787743|NCT00844883|Secondary|Efficacy - Factors Associated With Overall Survival (OS) After Combination Treatment With Sorafenib and TACE|Overall survival was assessed with Kaplan-Meier estimates of survival, and the Mantel-Cox log-rank test was used to determine differences in survival.|3 years|||Hazard ratio||95% Confidence Interval|Number
787744|NCT00844883|Secondary|Efficacy - Overall Survival (OS) After Combination Treatment With Sorafenib and TACE|"Overall survival was assessed with Kaplan-Meier estimates of survival, and the Mantel-Cox log-rank test was used to determine differences in survival.
All 50 patients were included in survival analyses as all 50 received at least one dose of sorafenib."|3 years|||months||Inter-Quartile Range|Median
787745|NCT00844883|Secondary|Efficacy - Median TTP After Combination Treatment With Sorafenib and TACE|"Time to progression (TTP) - defined as the time from initiation of therapy to disease progression (radiological). Median TTP calculated for all subjects and stratified by Barcelona Clinic Liver Cancer (BCLC) staging.
46 patients out of 50 were reviewed for this outcome. 3 patients were excluded because they underwent liver transplantation and 1 patient was excluded for hepatic resection."|3 years|Median TTP stratified by BCLC staging; 3 patients had BCLC stage A disease, 14 with stage B, and 29 with stage C.||months||Inter-Quartile Range|Median
787746|NCT00844883|Secondary|Efficacy Assessed by European Association for the Study of the Liver (EASL) Criteria to Determine Response and Disease Control Rate|"Efficacy as assessed by radiographic tumor response using the EASL criteria at baseline and at 6 months post the initiation of treatment.
Complete response (CR): 100% tumor necrosis Partial Response (PR): more than 50% tumor necrosis Progressive Disease (PD): increase in tumor enhancement by more than 25% Stable Disease (SD): Cases that do not qualify for one of the above criteria"|6 months|32 out of the 50 patients had imaging assessable by EASL criteria at 6 months - 18 out of the original 50 had exited prior to this time point or did not have applicable imaging.||Participants|||Count of Participants
787768|NCT00845130|Primary|Quantify the Effect of Chronic Hyperglycemia on Cellular Uptake of Vitamin C Across the Blood-brain Barrier|Concentrations of vitamin C after IV infusion of Vitamin C were measured in the brains of patients with type 2 diabetes and healthy controls to examine whether the concentrations are different between two groups.|2 hour post infusion|Data from one healthy subject were not usable due to subject's movement during MRI scan.||µmol/g tissue||Standard Deviation|Mean
787747|NCT00844883|Secondary|Efficacy Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) to Determine Response and Disease Control Rate|"Efficacy as assessed by radiographic tumor response using the RECIST criteria at baseline and at 6 months post the initiation of treatment. 33 out of the original 50 patients were evaluable at this time point, with 17 out of the 50 exiting prior to 6 months or were not assessable by RECIST criteria.
Complete response (CR): Disappearance of all lesions targeted with therapy Partial Response (PR): at least 30% decrease in sum of longest diameter (LD) of targeted lesions Progressive Disease (PD): at least 20% increase in the sum of LD of targeted lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR or sufficient increase to qualify for PD"|6 months|33 out of the original 50 patients were evaluable for this outcome, with 17 out of the original 50 exiting prior to 6 months or were not assessable by RECIST criteria.||Participants|||Count of Participants
787748|NCT00844883|Primary|Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.|Treatment toxicities assessed by CTCAE v3.0 were stratified by cycle - patients on Cycle 1, and patients on Cycles 2-5 or more.|2 years (Cycles 2-5+)|39 patients were reviewed for toxicities for Cycle 2-5+. 11 patients out of the original 50 exited the study prior to Cycle 2.||# of participants with adverse events|||Number
787749|NCT00844883|Primary|Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.|Treatment toxicities assessed by CTCAE v3.0 were stratified by cycle - patients on Cycle 1, and patients on Cycles 2-5 or more. 50 patients were reviewed for toxicities for Cycle 1, and all 50 patients experienced at least one adverse event during this time period.|6 weeks (Cycle 1)|||# of participants with adverse events|||Number
787750|NCT00844896|Primary|Change From Baseline in Burn Outcomes Questionnaire Short Form (5-18 Year Old Version) From Six Months.|Burn Outcomes Questionnaire (American Burn Association/Shriners Hospitals for Children) Short Form (5-18 Year Old Version) is a 3-item questionnaire with scores ranging from 0-18. A higher score is indicative of worse outcomes. Used for five year olds in the study. Change in scores were observed from baseline to six month follow-up.|baseline and six month follow-up|Intention to Treat (ITT)||units on a scale||Standard Deviation|Mean
787751|NCT00844896|Primary|DEF Participation|Outcomes in this measure were quantified by the number of participants in either intervention (DEF-only or COPE+DEF). During the study, DEF intervention was part of the standard of care for all patients at Shriners Hospitals for Children-Boston and thus every participant in this study had been evaluated using DEF to determine distress, emotional and family support.|Baseline|Intentional to treat (ITT)||participants|||Number
787752|NCT00844896|Primary|Change From Baseline in Stanford Acute Stress Reaction Questionnaire at Six Months|Stanford Acute Stress Reaction Questionnaire is a 31-question self-report measure for acute stress in parents. Scores range from 0-155 with a higher score indicative of worse outcomes. Change in scores were observed from baseline to six month follow-up.|Baseline and six-month follow-up|Intention to treat (ITT)||units on a scale||Standard Deviation|Mean
787753|NCT00844896|Primary|Change From Baseline in Hospital Emotional Support Form From Six Months|Hospital Emotional Support Form is a 12-question form that rates parents/caregivers need for in-hospital emotional support. Scores range from 11-24, with a lower score indicative of worse outcomes. Change in scores were observed from baseline to six month follow-up.|Baseline and six-month follow-up|Intention to treat (ITT)||units on a scale||Standard Deviation|Mean
787754|NCT00844896|Primary|Change From Baseline in PTSD Semi-Structured Interview at Six Months|Posttraumatic Stress Disorder Semi-Structured Interview is based on DSM-IV criteria, with a higher score indicative of increased symptoms of PTSD. The total rating was scored from 19 questions in three clusters of symptoms, with a score range of 0-38. Change in scores were observed from baseline to six month follow-up.|Baseline and six-month follow-up|Intention to treat (ITT)||units on a scale||Standard Deviation|Mean
787755|NCT00844896|Primary|Change From Baseline in Child Stress Reaction Checklist Short Form at Six Month|Child Stress Reaction Checklist Short Form is a 9-item parent-rated checklist. Scores range from 0-18 with a higher score indicative of worse outcomes. Change in scores were observed from baseline to six month follow-up|Baseline and six month follow-up|Intention to treat (ITT)||units on a scale||Standard Deviation|Mean
787756|NCT00844896|Primary|Change From Baseline in Parenting Stress Index at Six Months|Parenting Stress Index is a 12-item parent-rated questionnaire which employs a 1-5 Likert scale. Scores range from 12-60, with a lower score indicative of worse outcomes and a cutoff of 15. Change in scores were observed from baseline to six month follow-up.|Baseline and six month follow-up|Intention to treat (ITT)||units on a scale||Standard Deviation|Mean
787757|NCT00844896|Primary|Change From Baseline in Pediatric Symptom Checklist at Six Months|Pediatric Symptom Checklist is an 18-item psychosocial checklist in which symptoms are rated from 0 (never) to 2 (often) and the last question is rated as yes or no (0 or 1). Items are summed and the score can range from 0-35, with a higher score indicative of more symptoms and a worse outcome. Change in scores were observed from baseline to six month follow-up|Baseline and six month follow-up|Intention to Treat (ITT)||units on a scale||Standard Deviation|Mean
787758|NCT00844896|Primary|Change From Baseline in Burn Outcomes Questionnaire Short Form (0-4 Year Old Version) at Six Months|Burn Outcomes Questionnaire (American Burn Association/Shriners Hospitals for Children) Short Form (0-4 year old version). Parent-rated questionnaire that focuses on child's pain and parent's worry. Scores range from 5-24, with a higher score indicative of worse outcomes. Change in scores was measured from baseline to six month follow-up|Baseline and six month follow-up|Intention to Treat (ITT)||units on a scale||Standard Deviation|Mean
787769|NCT00845130|Primary|Concentration of Vitamin C in Type 2 Diabetic Patients.|Concentrations of vitamin C were measured in the brains of type 2 Diabetic patients and healthy controls.|Pre-Vitamin C infusion|Determine cerebral concentrations of vitamin C. Data from one healthy subject were not usable due to subject's movement during MRI scan.||umol/g tissue||Standard Deviation|Mean
787794|NCT00845663|Secondary|Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Pain|Categorized answer ranges from not at all to extremely.|Immediately after injection, 1 h and 24 h after injection|Intent-to-treat population||Participants|||Number
787759|NCT00845000|Secondary|Mean Peak Walking Speed|Walking speed assessment began with the participant being seated in an armless chair. Then while being timed, the participant stood up with their arms crossed on their chest and walked 6 meters, turned around, returned to the chair and sat. Timing was stopped when the participant’s buttocks hit the chair and the total time was recorded. If the participant could not arise in 60 seconds, 60 seconds was entered in this line of the report form and the participant was tested again but allowed to push off to get out of the chair. Sixty seconds was the maximum time allowed to complete the walking assessment, thus 60 seconds was recorded as the time if they could not complete the task within this time limit. Walking speed was assessed at Hours 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7.0 and 8. The peak walking speed was recorded for each participant regardless of what timepoint the score was achieved. The mean peak walking speed was calculated using the individual peak values.|Hours 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0 of each treatment period|All participants who received at least 1 dose of study drug and had available data for endpoint. Results pooled by study drug and not by randomly assigned sequence.||Seconds||Standard Deviation|Mean
787760|NCT00845000|Secondary|Mean Peak Tremor Score|Tremor was scored on a scale of 0 (absent), 1 (mild, 2 (moderate), 3 (severe) and 4 (incapacitating) for seven body parts (face, neck, trunk, each arm and each leg) based on the worse tremor observed during the time spent with participant while taking other study measurements(vital signs, drawing samples, performing the tapping and walking tasks). Scores were assessed at Hours 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0. The tremor score was the sum of scores for seven body parts. The peak tremor score was recorded for each participant regardless of what timepoint the score was achieved. The total possible score for an individual at each timepoint could range from 0 to 28 with higher scores indicating more effects of the tremors. The mean peak tremor score was calculated using the individual peak values.|Hours 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0 of each treatment period|All participants who received at least 1 dose of study drug and had available data for endpoint. Results pooled by study drug and not by randomly assigned sequence.||Score on a scale||Standard Deviation|Mean
787761|NCT00845000|Secondary|Mean Peak Finger Tapping Score|Tapping was measured with two manual counters with keys that were depressed to register a count. The participant alternately tapped each counter using the index finger of the more affected hand for 60 seconds and was not allowed to use more than one finger to tap. The participant was instructed to tap as rapidly as possible while being timed for 60 seconds. The counts were recorded for the two counters at Hours 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0. The peak tapping score was recorded for each participant regardless of what timepoint the score was achieved. The mean peak finger tapping score was calculated using the individual peak values.|Hours 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0 of each treatment period|All participants who received at least 1 dose of study drug and had available data for endpoint. Results pooled by study drug and not by randomly assigned sequence.||taps per 60 seconds||Standard Deviation|Mean
787762|NCT00845000|Primary|Mean Peak Dyskinesia Score|Dyskinesia was scored on a scale of 0 (absent), 1 (mild) , 2 (moderate), 3 (severe) and 4 (incapacitating) for seven body parts (face, neck, trunk, each arm and each leg) based on the worse dyskinesia noted during the entire measurement time. Scores were assessed at Hours 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0. The dyskinesia score was the sum of the scores for the seven body parts. The peak dyskinesia score was recorded for each participant regardless of what timepoint the score was achieved. The total possible score for an individual at each timepoint could range from 0 to 28 with higher scores indicating greater effects of the dyskinesia. The mean peak dyskinesia score was calculated using the individual peak values.|Hours 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0 of each treatment period|All participants who received at least 1 dose of study drug and had available data for endpoint. Results pooled by study drug and not by randomly assigned sequence.||Score on a scale||Standard Deviation|Mean
787763|NCT00845065|Secondary|Mean Log Change From Baseline to TW 4 in Viral Load by Visit|HCV-RNA levels were quantified using the Roche Cobas Taqman 1.0 assay; lower limit of detection of 15 international units [IU]/mL. Changes in HCV-RNA IU/ml were expressed on a log10 scale.|From Baseline to TW 4|FAS Population||log10 (IU/mL)||Standard Deviation|Mean
787764|NCT00845065|Secondary|Number of Participants With Undetectable HCV-RNA at Follow-up Week 12||Follow-up Week 12|FAS Population||Participants|||Number
787765|NCT00845065|Secondary|Percentage of Participants With Early Virologic Response (EVR) Who Achieved SVR|EVR was defined as the time to the first undectectable HCV-RNA result at Treatment Week (TW) 2, 4, 8, or 12. Participants with a detectable, but not quantifiable HCV-RNA result at TW 12 may have undergone retesting. Participants with a detectable result on retesting were to be discontinued per the 12-week futility rule. Participants with an undetectable result on retesting were allowed to continue on treatment, and the detectable but not quantifiable result was to be considered a false positive.|Day 1 to Treatment Week 12|FAS Population||Percentage of Participants|||Number
787766|NCT00845065|Secondary|SVR Rate in the Modified Intent-to-Treat (mITT) Population|SVR rate was the percentage of participants treated with at least one dose of study medication (Boceprevir/PEG2a/Ribavirin or PEG2a/Ribavirin). Participants who discontinued study drugs during the 4-week PEG2a/Ribavirin lead-in period were not included in the mITT population.|Follow-up Week 24|mITT Population: all randomized participants who received at least one dose of study medication (Boceprevir/PEG2a/Ribavirin or PEG2a/Ribavirin). Participants who discontinued study drugs during the 4-week PEG2a/Ribavirin lead-in period were not included. FU W12 value was LOCF, if last SVR value at or after FU W24 was not available.||Percentage of Participants|||Number
787767|NCT00845065|Primary|Sustained Virologic Response (SVR) Rate in Full Analysis Set (FAS) Population.|SVR rate was the percentage of participants treated with at least one dose of study medication (PEG2a, Ribavirin, or Boceprevir/Placebo) who had achieved SVR. SVR was defined as undetectable Hepatitis C Virus-Ribonucleic Acid (HCV RNA).|Follow-up Week 24|FAS Population: all randomized participants who received at least one dose of study medication (PEG2a, Ribavirin, or Boceprevir/Placebo). Follow-up (FU) Week (W) 12 value was Last Observation Carried Forward (LOCF), if last SVR value at or after FU W24 was not available.||Percentage of Participants|||Number
787773|NCT00845195|Primary|Mean Change in Instantaneous Total Ocular Symptom Scores (iTOSS) From Baseline|Responses to patient-completed diaries for instantaneous Total Ocular Symptom Scores (iTOSS). TOSS is composed of 3 individual assessments of ocular symptoms (itching/burning, tearing/watering, redness) each of the 3 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 3 assessments are then added together for a composite score (TOSS score), the maximum of which could be 9 . Instantaneous scores were assessed at the time of daily dosing.|14 days minus baseline|The analysis was per protocol. 15 patients were not included in the analysis.||Units on a scale||Standard Deviation|Mean
787774|NCT00845195|Primary|Mean Change in Instantaneous Total Nasal Symptom Scores (iTNSS) From Baseline|Responses to patient-completed diaries for instantaneous Total Nasal Symptom Scores (iTNSS). TNSS is composed of 4 individual assessments, which included runny nose, itchy nose, stuffy nose, and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are then added together for a composite score (TNSS score), the maximum of which could be 12 . Instantaneous scores were assessed at the time of daily dosing.|14 days minus baseline|The analysis was per protocol. 15 patients were not included in the analysis.||Units on a scale||Standard Deviation|Mean
787775|NCT00845195|Primary|Mean Change in Reflective Total Ocular Symptom Scores (rTOSS) From Baseline|Responses to patient-completed diaries for reflective Total Ocular Symptom Scores (rTOSS). TOSS is composed of 3 individual assessments of ocular symptoms (itching/burning, tearing/watering, redness) each of the 3 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 3 assessments are then added together for a composite score (TOSS score), the maximum of which could be 9 . Reflective scores were assessed from the hour since the last dose of study medication.|14 days minus baseline|The analysis was per protocol. 15 patients were not included in the analysis.||Units on a scale||Standard Deviation|Mean
787776|NCT00845195|Primary|Mean Change in Reflective Total Nasal Symptom Score (rTNSS) From Baseline|Responses to patient-completed diaries for reflective Total Nasal Symptom Scores (rTNSS). TNSS is composed of 4 individual assessments, which included runny nose, itchy nose, stuffy nose, and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are then added together for a composite score (TNSS score), the maximum of which could be 12 . Reflective scores were assessed from the hour since the last dose of study medication.|14 days minus baseline|The analysis was per protocol. 15 patients were not included in the analysis.||Units on a scale||Standard Deviation|Mean
787777|NCT00845429|Secondary|Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine.|"Solicited Injection Site Reactions: Pain, erythema or redness, swelling, ecchymosis, and induration.
Solicited Systemic Reactions: Fever (temperature), headache, malaise, myalgia, and rigors."|Day 0 up to Day 7 post-vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.||Participants|||Number
787778|NCT00845429|Primary|Percentage of Participants Achieving Seroconversion or Significant Increase at Day 21 Following Vaccination With Influenza Vaccine.|"Seroconversion: For participants with a Day 0 pre-vaccination titer < 10 (1/dil), titer ≥ 40 (1/dil) on Day 21.
Significant Increase: For participants with a Day 0 pre-vaccination titer ≥ 10 (1/dil), ≥ 4-fold increase of titer on Day 21."|Day 21 post-vaccination|Seroconversion and significant increase in Influenza vaccine antibodies were assessed in the full analysis set population.||Percentage of Participants|||Number
787779|NCT00845429|Primary|Percentage of Participants With Seroprotection to Each of the Influenza Vaccine Antigen Before and Post-vaccination.|Seroprotection was defined as a titer ≥ 40 1/dil, and determined in participants with a valid serology result for the particular Flu strain, including results reported as less than lower limit of quantitation (LLOQ)|Day 21 post-vaccination|Seroprotection was assessed in the full analysis set population.||Percentage of Participants|||Number
787780|NCT00845429|Primary|Summary of the Pre- and Post-Vaccination Geometric Mean Titers (GMTs) for Each of the Influenza Vaccine Antigens.||Days 0 and 21 post-vaccination|Geometric mean titers were assessed in the full analysis set population.||Titers||95% Confidence Interval|Geometric Mean
787781|NCT00845481|Primary|The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Diprosalic Ointment|The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst)|Baseline and 3 weeks|||Scores on a scale||Standard Error|Mean
787782|NCT00845481|Primary|The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Dermovat Ointment|The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst)|Baseline and 3 weeks|||Scores on a scale||Standard Error|Mean
787783|NCT00845481|Primary|The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Daivobet Ointment Vehicle|The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst)|Baseline and 3 weeks|||Scores on a scale||Standard Error|Mean
787784|NCT00845481|Primary|The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Elocon Ointment|The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst)|Baseline and 3 weeks|||Scores on a scale||Standard Error|Mean
787785|NCT00845481|Primary|The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Betnovat® Ointment|The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst)|Baseline and 3 weeks|||Scores on a scale||Standard Error|Mean
787786|NCT00845481|Primary|The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Daivobet® Ointment|The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst)|Baseline and 3 weeks|||Scores on a scale||Standard Error|Mean
787787|NCT00845663|Secondary|Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Hardening|Categorized answer ranges from not at all to extremely.|Immediately after injection, 1 hour and 24 hours after injection|Intent-to-treat population||Participants|||Number
787788|NCT00845663|Secondary|Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Bruising|Categorized answer ranges from not at all to extremely.|Immediately after injection, 1 hour and 24 hours after injection|Intent-to-treat population||Participants|||Number
787797|NCT00845663|Secondary|Injection Pain Assessment on a Visual Analog Scale (VAS) Per Formulation and Per Time Point as Well as Change From Baseline (=Immediately After Injection) at One Hour After Injection|Visual Analog Scale (VAS) ranges from 0 (no pain at all) to 100 mm (max. pain).|Immediately after injection and 1 hour after injection|Intent-to-treat population||Units on a scale||Standard Deviation|Mean
787798|NCT00845663|Secondary|Number of Subjects With Anti-certolizumab Pegol Antibody Plasma Level >2.4 Units/mL||After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12|Per Protocol Population||Participants|||Number
787799|NCT00845663|Secondary|Apparent Volume of Distribution (Vz/F)||After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12|Per Protocol Population||L||Full Range|Geometric Mean
787800|NCT00845663|Secondary|Apparent Total Body Clearance (CL/F)||After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12|Per Protocol Population||mL/day||Full Range|Geometric Mean
787801|NCT00845663|Secondary|Time Corresponding to Cmax (Tmax)||After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12|Per Protocol Population||days||Full Range|Median
787802|NCT00845663|Secondary|Apparent Terminal Elimination Half-life (t1/2)||After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12|Per Protocol Population||days||Full Range|Median
787803|NCT00845663|Secondary|Apparent Terminal Elimination Rate Constant (λz)||After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12|Per Protocol Population||1/day||Standard Deviation|Mean
787804|NCT00845663|Secondary|Lowest Quantifiable Concentration Time (LQCT)||After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12|Per Protocol Population||days||Full Range|Median
787805|NCT00845663|Secondary|Time Point Where Log-linear Elimination Phase Begins (TLIN)|TLIN describes timepoint for start of elimination phase determined on the basis of a linear regression model of the log-transformed concentration data.|After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12|Per Protocol Population||days||Full Range|Median
787806|NCT00845663|Primary|Maximum Plasma Concentration (Cmax)||After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12|Per Protocol Population||microgram/mL||Full Range|Geometric Mean
787807|NCT00845663|Primary|Area Under the Plasma Drug Concentration-time Curve From Time 0 to the Last Quantifiable Point (AUC(0-t))||After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12|Per Protocol Population||microgram*day/mL||Full Range|Geometric Mean
787808|NCT00845663|Primary|Area Under the Plasma Drug Concentration-time Curve From Time 0 to Infinity (AUC)||After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12|Per Protocol Population||microgram *day/mL||Full Range|Geometric Mean
787809|NCT00845676|Secondary|Association of SVR With Entry HCV RNA, Entry ALT, Entry CD4, and IL28B Genotype|Predictors of SVR, including early HCV RNA response to treatment as they relate to SVR|24 weeks||||||
787810|NCT00845676|Secondary|Safety and Tolerability of Treatment|Number of participants with treatment-associated problems|48 weeks||||||
787811|NCT00845676|Primary|Sustained Virologic Response (SVR)|Proportion of subjects achieving a sustained virologic response (SVR), defined as undetectable HCV RNA 24-weeks after completion of treatment|24 weeks|||percentage of participants|||Number
787812|NCT00845702|Primary|Percent of Non Assessable Renal Artery Segments|For each examination (TOF and Dotarem MRA) the percent of non-assessable segment will be compared|1 to 7 days|The study has been prematurely terminated, and the planned analyses were not done|||||
787813|NCT00845728|Secondary|Rate of COPD Exacerbations|COPD exacerbations were defined as :Worsening of 2 or more major symptoms for at least 2 consecutive days: dyspnea; sputum volume; suputum purulence AND requiring treatment with systemic corticosteroids and/or antibiotics OR Worsening of any 1 major symptom together with any 1 of the following minor symptoms for at least 2 consecutive days: Sore throat; colds; fever without other cause; increased cough; increase wheeze AND requiring treatment with systemic glucocorticosteroids and/or antibiotics. The rate was analyzed using a linear model assuming a negative binomial distribution for the PPS-E. The time at risk for a patient was defined as the length of time the patient was in the study and the log(length of time in the study) was used as the offset variable in the model.|52 weeks|Per-Protocol Set for Exacerbations (PPS-E). This set included Full Analysis Set (FAS) patients without any major protocol deviations or non-protocol deviation criteria that could affect the respective analysis of efficacy.||Exacerbations per patient per year|||Number
787814|NCT00845728|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1).|The primary objective of the study was to demonstrate the non-inferiority of indacaterol vs. tiotropium with respect to 24 hour post dose (trough) FEV1 after 12 weeks of treatment in patients with severe COPD. Trough FEV1 was defined as the average of the 23 hours 10 min and the 23 hours 45 min post dose values. Trough FEV1 was analyzed using a mixed model for the PPS-S. The model contained treatment as a fixed effect with the baseline FEV1, FEV1 prior to inhalation and FEV1 15 min post-inhalation of salbutamol/albuterol (components of SABA reversibility at Visit 2), FEV1 prior to inhalation and FEV1 60 min post-inhalation of ipratropium (components of anti-cholinergic reversibility at Visit 3) as covariates. Smoking history (current or ex-smoker) was included as a factor in the model.|12 weeks|Per-Protocol Set for Spirometry (PPS-S) This set included Full Analysis Set (FAS) patients without any major protocol deviations or non-protocol deviation criteria that could affect the respective analysis of efficacy.||Liters||Standard Error|Least Squares Mean
787815|NCT00845832|Secondary|Change From Baseline to Week 48 in Participant’s Assessment of Pain|Participant's Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm = no pain and 100 mm = maximum pain. The participant marked the line according to their assessment and the distance from the left edge was measured.|Baseline and Week 48|Data were not collected because the study was terminated early.|||||
787816|NCT00845832|Secondary|Change From Baseline to Week 48 in Participant’s Global Assessment of Disease Activity|Participant's Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity and 100 mm = maximum disease activity. The participant marked the line according to their assessment and the distance from the left edge was measured.|Baseline and Week 48|Data were not collected because the study was terminated early.|||||
787817|NCT00845832|Secondary|Change From Baseline to Week 48 in Physician’s Global Assessment of Disease Activity|Physician Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity and 100 mm= maximum disease activity. The physician marked the line according to their assessment and the distance from the left edge was measured.|Baseline and Week 48|Data were not collected because the study was terminated early.|||||
787820|NCT00845832|Secondary|Change From Baseline to Week 48 in Health Assessment Questionnaire (HAQ)|The Stanford Health Assessment Questionnaire disability index specific for rheumatoid arthritis was completed by the participants for efficacy assessments.|Baseline and Week 48|Data were not collected because the study was terminated early.|||||
787821|NCT00845832|Secondary|Change From Baseline to Week 48 in SJC and TJC|An assessment of 28 joints for swelling and tenderness will be made. Joints will be assessed and classified as swollen (1)/not swollen (0) and tender(1)/not tender (0) by pressure and joint manipulation on physical examination. Joint prosthesis, arthrodesis or fused joints were not taken into consideration for swelling or tenderness. The 28 joints assessed comprise shoulders (2 joints), elbows (2 joints), wrists (2 joints), metacarpophalangeal joints on digits 1-5 (10 joints), interphalangeal on digit 1 (2 joints), proximal interphalangeal joints on digits 2-5 (8 joints), and knees (2 joints).|Baseline and Week 48|Data were not collected because the study was terminated early.|||||
787822|NCT00845832|Secondary|Simplified Disease Activity Index (SDAI) Scores|The SDAI is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), Participant and Physician assessed global disease activity (assessed on 0-100 mm VAS; higher scores = greater affection due to disease activity), and ESR (mm/hour). SDAI total score ranged from 0 to 86. Higher scores indicated greater disease activity.|Baseline and Weeks 4, 8, 12, 16, 20, 24, 32, 40, and 48|Data were not collected because the study was terminated early.|||||
787823|NCT00845832|Secondary|Clinical Disease Activity Index Scores|"The Clinical Disease Activity Index (CDAI) score was calculated according to the following formula: CDAI = SJC + TJC + GH/10 + EGA/10
Where:
SJC = swollen joint count based on 28 joints; TJC = tender joint count based on 28 joints; GH = Participant’s global assessment of disease activity; EGA = evaluator’s (physician’s) global assessment of disease activity. CDAI scores range from 0-76 and the following cut-off points for different disease activity states have been used: high disease activity >22; moderate disease activity >10 and ≤22; LDA >2.8 and ≤10; and remission ≤ 2.8. No imputation used for TJC, SJC, Patient's Global Assessment of Disease Activity VAS and Physicians global assessment of disease activity VAS."|Baseline and Weeks 4, 8, 12, 16, 20, 24, 32, 40 and 48|ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint.||units on a scale||Standard Deviation|Mean
787824|NCT00845832|Secondary|Change From Baseline in DAS28-ESR|"The DAS28-ESR score is a measure of the participant's disease activity. It is based on the TJC (28 joints), SJC (28 joints), participant's global assessment of disease activity (mm), and ESR (mm/hour). DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst).
DAS28-ESR scores were calculated as follows: DAS28-ESR = (0.56 * √TJC)+(0.28 * √SJC)+(0.70 * ln(ESR))+(0.014 * GH).
No imputation used for tender and swollen joint counts, ESR, and patient's global assessment of disease activity VAS."|Weeks 4, 8, 12, 16, 20, 24, 32, 40 and 48|ITT Population; number (n) = number of participants analyzed at the specified visit.||units on a scale||Standard Deviation|Mean
787825|NCT00845832|Secondary|Percentage of Participants by European League Against Rheumatism (EULAR) Response Category at Week 16|DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline (greater than) >1.2 with DAS28 ≤3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to ≤5.1 or DAS28-ESR >5.1 or change from baseline >0.6 to ≤1.2 with DAS28 ≤5.1; nonresponders: change from baseline ≤0.6 or change from baseline >0.6 and ≤1.2 with DAS28 >5.1.|Week 16|ITT Population; No imputation used for TJC, SJC, ESR, and PtGA. EULAR response was set to missing when the DAS28 score was missing.||percentage of participants|||Number
787826|NCT00845832|Secondary|Percentage of Participants Achieving Remission at Week 16 Assessed Using DAS28-ESR|The DAS28-ESR score is a measure of the participant's disease activity. It is based on the TJC (28 joints), SJC (28 joints), participant's global assessment of disease activity (mm), and ESR (mm/hour). DAS28-ESR is expressed on a unit on a scale with the minimum score=0 (best) to maximum score=10 (worst). Remission was defined as DAS28-ESR less than (<) 2.6|Week 16|ITT Population; LOCF used for TJC, ESR, and PtGA. If the DAS28-ESR value was missing then remission or LDA was missing.||percentage of participants|||Number
787827|NCT00845832|Primary|Percentage of Participants Achieving Low Disease Activity (LDA) at Week 16 Assessed Using Disease Activity Score Based on 28 Joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR)|"The Disease Activity Score based on 28 joint count (DAS28) and Erythrocyte Sedimentation Rate (ESR), is a measure of the participant's disease activity. It is based on the Tender Joint Count (TJC [28 joints]), Swollen Joint Count (SJC [28 joints]), participant's global assessment of disease activity (PtGA) Visual Analog Scale (VAS) in millimeters (mm), and ESR in millimeters per hour (mm/hour). DAS28-ESR scores range from 0 - 10. Definition of LDA was based on DAS28-ESR scores. To achieve LDA the DAS28-ESR had to be (less than or equal to) ≤ 3.2.
DAS28-ESR equals (=) (0.56 times (*) (square root)√ TJC plus (+) (0.28 * √ SJC + (0.70 * ln(ESR))+(0.014 * (Global Health) GH)
Where:
TJC = based on 28 joints SJC = based on 28 joints ESR = erythrocyte sedimentation rate in mm/hour GH = participant’s global assessment of disease activity ln = natural log"|Week 16|Intent-to-Treat (ITT) Population: all randomized participants who received any part of an infusion of study medication. Last observation carried forward (LOCF) used for TJC and SJC, ESR and PtGA. If DAS28-ESR value was missing LDA was missing.||percentage of participants|||Number
787828|NCT00845845|Secondary|Magnetic Resonance Imaging (MRI) as an Assessment of Hepatic Steatosis in Patients With Biopsy-proven Nonalcoholic Steatohepatitis (NASH)||24 weeks|This study was terminated on October 12, 2010 due to low enrollment. Primary analyses were never completed.|||||
787829|NCT00845845|Primary|Omega-3 Fatty Acid Supplementation and Its Effect on Hepatic Steatosis and Other Factors Associated With the Development of Nonalcoholic Steatohepatitis (NASH)||24 weeks|This study was terminated on October 12, 2010 due to low enrollment. Primary analyses were never completed.|||||
787875|NCT00851721|Secondary|Abnormal Activated Partial Thromboplastin Time (aPTT) Assay Results|The normal reference range of values for aPTT is 22.8 – 31 seconds.|Screening visit, Month 3, Month 6, Month 9, and Termination visit|Safety Analysis Set Participants with Clinically Significant Laboratory Results||seconds||Inter-Quartile Range|Median
787876|NCT00851721|Secondary|The Number of Bleeding Episode (BE) Which Required 1, 2, 3, or ≥4 Infusions to Control Bleeding||12 months ± 14 days|"Additional Evaluations for Bleeding Episodes Analysis Set
- Consists of all participants with at least 1 bleeding episode treated with investigational product, FEIBA NF."||Bleeding Episodes (BEs)|||Number
787830|NCT00845858|Other Pre-specified|The Pre-specified Endpoint is the Change From Baseline to Week 4 of the Treatment Period in the Modified Gastroparesis Cardinal Symptom Index-Daily Diary (mGCSI-DD) Total Score by Gender.|"Change from Baseline to Week 4 of the treatment period in the mGCSI-DD total score in Female subjects receiving metoclopramide nasal spray versus Female subjects receiving placebo.
The mGCSI-DD is a patient reported outcome measure of gastroparesis symptom severity composed of 4 individual symptoms (listed below) with each symptom graded on a scale from 0 (none) to 5 (very severe).
Nausea (feeling sick to your stomach as if you were going to vomit or throw up)
Early satiety (not able to finish a normal sized meal)
Bloating (feeling like you need to loosen clothes)
Upper abdominal pain (above the navel) The mGCSI-DD daily score is a mean of the 4 individual symptom scores. The total score is a mean of the daily scores for the observation period.
A mean change (improvement) of >1 category (for example, moderate to mild or severe to moderate) is considered to be clinically meaningful."|4 weeks|||units on a scale||Standard Deviation|Mean
787831|NCT00845858|Primary|The Primary Efficacy Endpoint is the Change From Baseline to Week 4 of the Treatment Period in the Modified Gastroparesis Cardinal Symptom Index-Daily Diary (mGCSI-DD) Total Score.|"Change from Baseline to Week 4 of the treatment period in the mGCSI-DD total score in male and female subjects receiving metoclopramide nasal spray versus subjects receiving placebo.
The mGCSI-DD is a patient reported outcome measure of gastroparesis symptom severity composed of 4 individual symptoms (listed below) with each symptom graded on a scale from 0 (none) to 5 (very severe).
Nausea (feeling sick to your stomach as if you were going to vomit or throw up)
Early satiety (not able to finish a normal sized meal)
Bloating (feeling like you need to loosen clothes)
Upper abdominal pain (above the navel) The mGCSI-DD daily score is a mean of the 4 individual symptom scores. The total score is a mean of the daily scores for the observation period.
A mean change (improvement) of >1 category (for example, moderate to mild or severe to moderate) is considered to be clinically meaningful."|4 weeks|ITT||units on a scale||Standard Deviation|Mean
787832|NCT00851552|Secondary|Safety||2 years|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.|||||
787833|NCT00851552|Primary|Antitumor Efficacy in Terms of Overall, Complete, and Partial Response Rates and Time to Progression at Weeks 9 and 21||at weeks 9 and 21|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.|||||
787834|NCT00851591|Secondary|Secondary Outcome Variables Are to Include Milk-fat Content and Protein Content.||day 0; day 8||||||
787835|NCT00851591|Primary|The Main Outcome Variable of This Study is the Quantity of Milk Produced.|The single value was calculated average from day 0 and day 8.|"Day 0 , Day 8"|Analysis was per protocol.||mL/hr||Standard Deviation|Mean
787836|NCT00851630|Secondary|HIV RNA Level < 50 Copies/ml|The number of subjects with plasma HIV RNA level <50 copies/ml.|104 Weeks|Intent to Treat, missing = failure.||Participants|||Number
787837|NCT00851630|Secondary|Plasma HIV Ribonucleic Acid (RNA) Level < 400 Copies/ml|The number of subjects with plasma HIV RNA level <400 copies/ml.|104 Weeks|Intention to Treat Analysis, missing = failure.||Participants|||Number
787838|NCT00851630|Primary|Tuberculosis-immune Reconstitution Inflammatory Syndrome Events|Tuberculosis-immune reconstitution inflammatory syndrome was defined by the protocol as: a) new persistent fevers (temperature >101.5 degrees Fahrenheit) developing after the initiation of antiretroviral therapy, and not believed to be associated with antiretroviral therapy and without an identifiable source, b) marked worsening or emergence of intrathoracic lymphadenopathy, pulmonary infiltrates or pleural effusions on radiologic examination, or c) worsening or emergence of lymphadenopathy on serial examinations or worsening of other tuberculous lesions.|104 weeks|Intention to treat.||Events|||Number
787839|NCT00851630|Primary|Number of Serious Adverse Events (SAEs)|Feasibility and safety of fixed dose combination zidovudine/lamivudine/abacavir in HIV-infected subjects with tuberculosis in a resource-limited setting as assessed by the number of serious adverse events. Serious adverse events included any untoward medical occurrence that resulted in death, was considered life-threatening, required inpatient hospitalization or prolongation of existing hospitalization beyond what was required in the study, or resulted in persistent or resulted in significant disability/incapacity.|104 weeks|Intention to treat.||Events|||Number
787840|NCT00851643|Primary|Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase B|A vaccinated participant was considered seropositive for a given HPV type if her serum antibody titer by cLIA for the HPV type was greater than the serostatus cutoff. The serostatus cutoffs for HPV Types 6, 11, 16, 18, 31, 45, 52, and 58 were 20, 20, 20, 20, 16, 16, 20, and 16 mMU/mL, respectively.|4 weeks postdose 3 (Phase B)|"PPI population: All participants who were not protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 and PCR-negative Day 1 through Month 7
for the relevant HPV type(s), and had a valid Month 7 serology result collected in the appropriate day range."||Participants|||Number
787841|NCT00851643|Primary|Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase A|A vaccinated participant was considered seropositive for a given HPV type if her serum antibody titer by cLIA for the HPV type was greater than the serostatus cutoff. The serostatus cutoffs for HPV Types 6, 11, 16, 18, 31, 45, 52, and 58 were 20, 20, 20, 20, 16, 16, 20, and 16 mMU/mL, respectively.|4 weeks postdose 3 (Phase A)|"PPI population: All participants who were not protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 and PCR-negative Day 1 through Month 7
for the relevant HPV type(s), and had a valid Month 7 serology result collected in the appropriate day range."||Participants|||Number
787842|NCT00851643|Primary|Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase B|The quadrivalent HPV (GARDASIL™) vaccine has types 6, 11, 16, 18, and the octavalent HPV has types 6, 11, 16, 18, 31, 45, 52, and 58. Serum antibody titres to the HPV type were obtained using cLIA after vaccination with GARDASIL™ or the octavalent HPV vaccine. GMTs were calculated and are reported as the antibody concentration in milli-Merck Units per milliliter (mMU/mL) of neutralizing monoclonal antibody equivalent.|4 weeks postdose 3 (Phase B)|"PPI population: All participants who were not protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 and PCR-negative Day 1 through Month 7
for the relevant HPV type(s), and had a valid Month 7 serology result collected in the appropriate day range."||mMU/mL||95% Confidence Interval|Geometric Mean
787877|NCT00851721|Secondary|Total Weight Adjusted Dose to Control a Bleeding Episode||12 months ± 14 days|"Additional Evaluations for Bleeding Episodes Analysis Set
- Consists of all participants with at least 1 bleeding episode treated with investigational product, FEIBA NF."||Units/kg||Inter-Quartile Range|Median
787843|NCT00851643|Primary|Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase A|The quadrivalent HPV (GARDASIL™) vaccine has types 6, 11, 16, 18, and the octavalent HPV has types 6, 11, 16, 18, 31, 45, 52, and 58. Serum antibody titres to the HPV type were obtained using a competitive Luminex immunoassay (cLIA) after vaccination with GARDASIL™ or the octavalent HPV vaccine. GMTs were calculated and are reported as the antibody concentration in milli-Merck Units per milliliter (mMU/mL) of neutralizing monoclonal antibody equivalent.|4 weeks postdose 3 (Phase A)|Per Protocol Immunogenicity (PPI) population: participants who were not protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 and polymerase chain reaction (PCR)-negative Day 1 through Month 7 for the relevant HPV type(s), had a valid Month 7 serology result collected in the appropriate day range.||mMU/mL||95% Confidence Interval|Geometric Mean
787844|NCT00851682|Secondary|Successful MRI Guidance of Transrectal Ultrasound Biopsy in Patients.|Ultrasound guidance of transrectal ultrasound biopsy was not attempted.|At time of treatment||||||
787845|NCT00851682|Primary|Improved Accuracy of Prostate Cancer Detection by MRI Scan.|Data obtained as part of this study could not be analyzed in a meaningful way due to problems with correlation between the cancerous tissue identified by histology and tissue imaging from imaging.|At time of treatment||||||
787846|NCT00851721|Secondary|Health-Related Quality of Life (HRQoL) - General Pain Assessment Using a Visual Analogue Scale (VAS) in Pediatrics <12 Years Old|"General pain was assessed using the children’s VAS pain scale (a facial expression scale with one end marked as no pain and the opposite end marked as the worst possible pain). Assessments were done at the screening, 6 months, and termination visits.
Scores on the children's VAS scale are presented as:
No Pain
Mild Pain
Moderate pain
Severe pain
Very severe pain
Unlike the VAS pain assessment for pain of bleeding episodes (Outcome above), this general pain assessment did not take use of analgesics into account.
Change in VAS scores at 6 months and study termination were also compared relative to Baseline/Screening scores (ie, (Baseline/Screening VAS score) - (VAS score at 6 months and study termination)."|Baseline, 6 months and 12 months ± 14 days|Health-Related Quality of Life (HRQoL) Intent-to-Treat Analysis Dataset - comprised of all participants <12 years old who were randomized, had any available assessments at any available study visits (baseline, 6-month, and 12-month) as defined in the protocol||participants|||Number
787847|NCT00851721|Secondary|Health-Related Quality of Life (HRQoL) - General Pain Assessment Using a Visual Analogue Scale (VAS) in Adults and Adolescents ≥12 Years Old|"General pain was assessed using a VAS pain scale at screening, 6 months, and at termination. Unlike the VAS pain assessment for pain of bleeding episodes (Outcome above), this general pain assessment did not take use of analgesics into account. For the pain scale, a higher number indicates worse pain.
The visual analog scale ranges from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (=0) and 'Best imaginable health state' (=100). A positive change from baseline indicates improvement.
Change in VAS scores at 6 months and study termination were also compared relative to Baseline/Screening scores (ie, (Baseline/Screening VAS score) - (VAS score at 6 months and study termination)."|Baseline, 6 months and 12 months ± 14 days|Health-Related Quality of Life (HRQoL) Intent-to-Treat Analysis Dataset - comprised of all participants ≥12 years old who were randomized, had any available assessments at any available study visits (baseline, 6-month, and 12-month) as defined in the protocol||Scores on a scale||Standard Deviation|Mean
787848|NCT00851721|Secondary|Hemophilia-specific Quality of Life Questionnaire for Children and Adolescents < 16 Years Old (Haemo-QoL) - Child's Evaluation|"The Haemo-QoL is a quality of life (QoL) assessment instrument for children and adolescents with haemophilia. As a hemophilia-specific instrument, this measure assesses very specific aspects of dealing with hemophilia. The areas covered by this instrument are: Physical Health (PH), Sports & School (S&S), Dealing with Hemophilia (Dealing), Family, Feeling, Relationships (R'ships), Treatment, View, Outlook for the Future (Future), Friends, Others, and Support. A Haemo-QoL Total Score (Total) was also calculated. For the Haemo-QoL, higher scores indicate a worse quality of life. Scores on a scale range between 0 and 100.
Haemo-QoL scores at screening, 6 months, and at termination visit were collected. Changes in scores at 6 months and termination were also calculated."|12 months ± 14 days|Health-Related Quality of Life (HRQoL) Intent-to-Treat Analysis Dataset - comprised of all participants <16 years old, had any available assessments at any available study visits (baseline, 6-month, and 12-month) as defined in the protocol||Scores on a scale||Standard Deviation|Mean
787849|NCT00851721|Secondary|Hemophilia-specific Quality of Life Questionnaire for Children and Adolescents < 16 Years Old (Haemo-QoL) - Parent's Evaluation|"The Haemo-QoL is a quality of life (QoL) assessment instrument for children and adolescents with haemophilia. As a hemophilia-specific instrument, this measure assesses very specific aspects of dealing with hemophilia. The areas covered by this instrument are: Physical Health (PH), Sports & School (S&S), Dealing with Hemophilia (Dealing), Family, Feeling, Relationships (R'ships), Treatment, View, Outlook for the Future (Future), Friends, Others, and Support. A Haemo-QoL Total Score (Total) was also calculated. For the Haemo-QoL, higher scores indicate a worse quality of life. Scores on a scale range between 0 and 100.
Haemo-QoL scores at screening, 6 months, and at termination visit were collected. Changes in scores at 6 months and termination were also calculated."|12 months ± 14 days|Health-Related Quality of Life (HRQoL) Intent-to-Treat Analysis Dataset - for all participants <16 years old who were randomized, had any available assessments at any available study visits (baseline, 6-month, and 12-month) as defined in the protocol||Scores on a scale||Standard Deviation|Mean
787850|NCT00851721|Secondary|Hemophilia-specific Quality of Life Questionnaire for Adults (Haem-A-QoL) ≥ 16 Years Old|"The Haem-A-QoL instrument has been developed and used in Hemophilia A patients. As a hemophilia-specific instrument, this measure assesses very specific aspects of dealing with hemophilia. The areas covered by this instrument are: Physical Health (PH), Sports & Leisure (S&L), School & Work (W&S), Dealing with Hemophilia (Dealing), Family Planning (FP), Feeling, Relationships (R'ships), Treatment, View, and Outlook for the Future (Future). A Haem-A-QoL Total Score (Total) was also calculated. For the Haem-A-QoL, higher scores indicate a worse quality of life. Scores on a scale range between 0 and 100.
Haem-A-QoL scores at screening, 6 months, and at termination visit were collected. Changes in scores at 6 months and termination were also calculated."|12 months ± 14 days|Health-Related Quality of Life (HRQoL) Intent-to-Treat Analysis Dataset for all participants ≥ 16 years old who were randomized, had any available assessments at any available study visits (baseline, 6-month, and 12-month) as defined in the protocol||Scores on a scale||Standard Deviation|Mean
787851|NCT00851721|Secondary|Health-Related Quality of Life (HRQoL): EuroQoL (Quality of Life)-5 Dimensions (EQ-5D) Index Scores|"EQ-5D is a participant answered questionnaire scoring 5 dimensions - mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ-5D total score ranges from 0 (worst health state) to 1 (perfect health state) and 1 reflects the best outcome.
EQ-5D Index scores based on EQ-5D questionnaire were calculated for participants ≥14 years of age, at screening, 6 months, and at termination visit. Changes in scores at 6 months and termination were also calculated.
A relatively higher score represents better quality of life."|12 months ± 14 days|HRQoL Intent-to-Treat Analysis Dataset - comprised of all participants ≥14 years of age who were randomized, had any available assessments at any available study visits (baseline, 6- month, and 12-month) as defined in the protocol||Scores on a scale||Standard Deviation|Mean
787852|NCT00851721|Secondary|Pharmacoeconomics: Annual Total Number of Days Lost (Work or School)||12 months ± 14 days|Pharmacoeconomic Analysis Set||Days||Standard Deviation|Mean
787853|NCT00851721|Secondary|Pharmacoeconomics: Annual Total Length of Hospitalization for Indwelling Line||12 months ± 14 days|Pharmacoeconomic Analysis Set||Days||Standard Deviation|Mean
787854|NCT00851721|Secondary|Pharmacoeconomics: Annual Total Length of Hospitalization for Bleeding||12 months ± 14 days|Pharmacoeconomic Analysis Set||Days||Standard Deviation|Mean
787855|NCT00851721|Secondary|Pharmacoeconomics: Annual Number of Physician’s Office Visits||12 months ± 14 days|Pharmacoeconomic Analysis Set||Physician's office visits||Standard Deviation|Mean
787856|NCT00851721|Secondary|Pharmacoeconomics: Annual Number of Emergency Room Visits||12 months ± 14 days|Pharmacoeconomic Analysis Set||Emergency room visits||Standard Deviation|Mean
787857|NCT00851721|Secondary|Pharmacoeconomics: Annual Number of Hospitalizations for Indwelling Line||12 months ± 14 days|Pharmacoeconomic Analysis Set||hospitalizations||Standard Deviation|Mean
787858|NCT00851721|Secondary|Pharmacoeconomics: Annual Number of Hospitalizations for Bleeding||12 months ± 14 days|Pharmacoeconomic Analysis Set||hospitalizations||Standard Deviation|Mean
787859|NCT00851721|Secondary|Pharmacoeconomics: Annual Days Lost Due to Bleeding (Work or School)||12 months ± 14 days|Intent to Treat Analysis Set||days||Standard Deviation|Mean
787860|NCT00851721|Secondary|Absolute Changes in Inhibitor Titer of Hemophilia B Participants With Shifts in Factor IX (FIX) Inhibitor Titer Levels|"Absolute Changes in Inhibitor Titer (or no change in low or high titer status):
Inhibitor Titer went from Low (≤5 BU) to Low (≤5 BU)
Inhibitor Titer went from Low (≤5 BU) to High (>5 BU)
Inhibitor Titer went from High (>5 BU) to Low (≤5 BU)
Inhibitor Titer went from High (>5 BU) to High (>5 BU)"|12 months ± 14 days|"Safety Analysis Set
- Hemophilia B study participants"||Bethesda Units (BU)||Inter-Quartile Range|Median
787861|NCT00851721|Secondary|Absolute Changes in Inhibitor Titer of Hemophilia A Participants With Shifts in Factor VIII (FVIII) Inhibitor Titer Levels|"Absolute Changes in Inhibitor Titer (or no change in low or high titer status):
Inhibitor Titer went from Low (≤5 BU) to Low (≤5 BU)
Inhibitor Titer went from Low (≤5 BU) to High (>5 BU)
Inhibitor Titer went from High (>5 BU) to Low (≤5 BU)
Inhibitor Titer went from High (>5 BU) to High (>5 BU)"|12 months ± 14 days|"Safety Analysis Set
- Hemophilia A study participants"||Bethesda Units (BU)||Inter-Quartile Range|Median
787862|NCT00851721|Secondary|Number of Related Thromboembolic Adverse Events (AEs)||12 months ± 14 days|Safety Analysis Set||Related thromboembolic AEs|||Number
787863|NCT00851721|Secondary|Rate of Related Adverse Events (AEs) During or Within 1 Hour of Infusion Per Year||12 months ± 14 days|Safety Analysis Set||Related AEs within/during 1hr per year||Inter-Quartile Range|Median
787864|NCT00851721|Secondary|Rate of Related Adverse Events (AEs) Per Year||12 months ± 14 days|Safety Analysis Set||Related AEs per year||Inter-Quartile Range|Median
787865|NCT00851721|Secondary|Viral Serology From Screening Visit and Study Termination Visit: Parvovirus B19 IgM Antibody [IV]|"Normal range (0 - 0.89 IV); High (> 0.89 IV)
- Parvovirus B19 IgM Antibody [IV] (Parvo IgM Ab)"|12 months ± 14 days|Safety Analysis Set||participants|||Number
787866|NCT00851721|Secondary|Viral Serology From Screening Visit and Study Termination Visit: Parvovirus B19 IgG Antibody [IV]|"Normal range (0 - 0.89 IV); High (> 0.89 IV)
- Parvovirus B19 IgG Antibody [IV] (Parvo IgG Ab)"|12 months ± 14 days|Safety Analysis Set||participants|||Number
787867|NCT00851721|Secondary|Viral Serology From Screening Visit and Study Termination Visit: HIV-1/2 Antibody (Ab)||12 months ± 14 days|Safety Analysis Set||participants|||Number
787868|NCT00851721|Secondary|Viral Serology From Screening Visit and Study Termination Visit: Hepatitis A, Hepatitis B, and Hepatitis C|"Hepatitis A Virus Antibody (HAV Ab)
Hepatitis B Virus Core Antibody (HBcAb)
Hepatitis B Virus Surface Antibody (HBsAb)
Hepatitis B Virus Surface Antigen (HBsAg)
Hepatitis C Virus (HCV)"|12 months ± 14 days|Safety Analysis Set||participants|||Number
787869|NCT00851721|Secondary|Abnormal Thrombin-Antithrombin III (TAT) Assay Results|The normal reference range of values for TAT is 1-4.1 ug/L.|Screening visit, Month 3, Month 6, Month 9, and Termination visit|Safety Analysis Set Participants with Clinically Significant Laboratory Results||ug/L||Inter-Quartile Range|Median
787870|NCT00851721|Secondary|Abnormal Prothrombin Time Assay Results|The normal reference range of values for PT is 9.7-12.3 sec.|Screening visit, Month 3, Month 6, Month 9, and Termination visit|Safety Analysis Set Participants with Clinically Significant Laboratory Results||seconds||Inter-Quartile Range|Median
787871|NCT00851721|Secondary|Abnormal Prothrombin Fragment F 1.2 Assay Results|The normal reference range of values for prothrombin fragment F 1.2 is 69-229 pmol/L.|Screening visit, Month 3, Month 6, Month 9, and Termination visit|Safety Analysis Set Participants with Clinically Significant Laboratory Results||pmol/L||Inter-Quartile Range|Median
787872|NCT00851721|Secondary|Abnormal Fibrin Degradation Products (FDP) Assay Results|The normal reference range of values for FDP is 0-5 ug/mL.|Screening visit, Month 3, Month 6, Month 9, and Termination visit|Safety Analysis Set Participants with Clinically Significant Laboratory Results||ug/mL||Inter-Quartile Range|Median
787873|NCT00851721|Secondary|Abnormal Fibrinogen Assay Results|The normal reference range of values for fibrinogen is 200-400 mg/dL.|Screening visit, Month 3, Month 6, Month 9, and Termination visit|Safety Analysis Set Participants with Clinically Significant Laboratory Results||mg/dL||Inter-Quartile Range|Median
787874|NCT00851721|Secondary|Abnormal D-Dimer Assay Results|The normal reference range of values for D-dimers is <500 ng/mL.|Screening visit, Month 3, Month 6, Month 9, and Termination visit|Safety Analysis Set Participants with Clinically Significant Laboratory Results||ng/mL||Inter-Quartile Range|Median
787878|NCT00851721|Secondary|Assessment of Hemostasis for Treatment of Bleeding Episodes- Overall Efficacy Rating at 24 Hours|"Number of rAHF-PFM-treated bleeding episodes with an assessment of hemostasis (4-point ordinal scale):
Excellent: Full pain relief & bleeding cessation within ~24 hours of 1 infusion. Additional infusions may have been given to maintain hemostasis;
Good: Definite pain relief and/or improvement in bleeding within ~24 hours after infusion. Possibly requires >1 infusion for complete resolution;
Fair: Probable or slight relief of pain & slight improvement in bleeding within
~24 hours after infusion. Requires >1 infusion for complete resolution;
None: No improvement or condition worsens"|24 ± 1 h post-infusion|Bleeding Episodes Analysis Set Consists of all participants who experienced a bleeding episode (BE)||bleeding episodes|||Number
787879|NCT00851721|Secondary|Assessment of Hemostasis for Treatment of Bleeding Episodes- Overall Efficacy Rating at 6 Hours|"Number of rAHF-PFM-treated bleeding episodes with an assessment of hemostasis (4-point ordinal scale):
Excellent: Full pain relief & bleeding cessation within ~6 hours of 1 infusion. Additional infusions may have been given to maintain hemostasis;
Good: Definite pain relief and/or improvement in bleeding within ~6 hours after infusion. Possibly requires >1 infusion for complete resolution;
Fair: Probable or slight relief of pain & slight improvement in bleeding within
~6 hours after infusion. Requires >1 infusion for complete resolution;
None: No improvement or condition worsens"|6 h ± 30 min post-infusion|Bleeding Episodes Analysis Set Consists of all participants who experienced a bleeding episode (BE)||bleeding episodes|||Number
787880|NCT00851721|Secondary|Assessment of Clinical Symptoms - Range of Motion (ROM)|ROM was measured using a goniometer for 3 key joints (ie, ankles, knees, and elbows) at screening, month 6, and termination (end of study visit)|12 months ± 14 days|Safety Analysis Set||degrees||Inter-Quartile Range|Median
787881|NCT00851721|Secondary|Assessment of Clinical Symptoms - Visual Analog Scale (VAS): Pain in Pediatrics (<12 Years Old)|"Pain caused by a bleeding episode (BE) in pediatric participants (<12 years old) was measured at pre-infusion (pre-inf) and at 6 ± 0.5 h and 24 ± 1 h post-infusion (post-inf) (after the last infusion given to treat a bleeding episode) using the children’s VAS pain scale (a facial expression scale with one end marked as no pain and the opposite end marked as the worst possible pain). For analysis purposes, if short acting analgesics (duration of activity approximately 6 ± 0.5 h) were used, pain was assigned the highest possible score (worst possible pain).
Scores on the children's VAS scale are presented as:
No Pain
Mild Pain
Moderate pain
Severe pain
Very severe pain"|12 months ± 14 days|Additional evaluations for bleeding episodes in the intent-to-treat analysis dataset: consists of all participants with at least 1 bleeding episode treated with investigational product.||Bleeding episodes|Bleeding episodes (BEs)||Number
787882|NCT00851721|Secondary|Assessment of Objective Clinical Symptoms- Visual Analog Scale (VAS): Pain in Adolescents and Adults (≥12 Years Old)|"Pain caused by a bleeding episode in adolescents and adults (≥12 years old) was measured at pre-infusion (pre-inf) and at 6 ± 0.5 hours (h) and 24 ± 1 h post-infusion (post-inf) (after the last infusion given to treat a bleeding episode) on the VAS pain scale in millimeters from 0 (no pain) to 100 (worst possible pain). For analysis purposes, if short acting analgesics (duration of activity approximately 6 ± 0.5 h) were used, pain was assigned the highest possible score (100). Pain assessment occurred after each infusion related to single bleeding episodes. In case participants required an additional infusion within 24h, pain was assessed 6 ± 0.5 h and 24 ±1 h following the subsequent infusion.
Change in VAS scores at 6 ± 0.5 h and 24 ±1 h post-infusion were also compared relative to pre-infusion VAS scores (ie, (pre-infusion VAS score) - (post-infusion VAS score))."|Throughout the study period, 12 months ± 14 days|Additional evaluations for bleeding episodes in the intent-to-treat analysis dataset: consists of all participants with at least 1 bleeding episode treated with investigational product.||Scores on a scale|Bleeding episodes|Inter-Quartile Range|Median
787883|NCT00851721|Secondary|Number of New Target Joints|Target Joints are defined as ≥4 bleeds/6 months in any one of the following joints: ankles, knees, elbows and hips|12 months ± 14 days|"Efficacy Intent to Treat Analysis Dataset:
Dataset consists of data from all randomized participants. Dataset includes those who discontinued FEIBA NF but did not withdraw informed consent and were willing to continue providing data. For these participants, only the data collected before FEIBA NF discontinuation is included."||new target joints|||Number
787884|NCT00851721|Secondary|Differences in Mean Transformed Annualized Bleeding Rate Between On-Demand and Prophylaxis Treatment Regimens: New Target Joints|"Annualized bleed rates (ABRs) were transformed using the square root of the number of bleeding episodes observed (X bleeds/year), X′ = √(X + 0.5). This transformation was performed to stabilize the variance and align the sample distribution with the assumption of normality inherent in using a two-sample, two-sided t-test.
The difference in mean transformed ABRs was used to perform statistical tests and generate p-values at a significance level of 5%"|12 months ± 14 days|"Efficacy Intent to Treat Analysis Dataset:
Dataset consists of data from all randomized participants. Dataset includes those who discontinued FEIBA NF but did not withdraw informed consent and were willing to continue providing data. For these participants, only the data collected before FEIBA NF discontinuation is included."||(bleeds/year)^(1/2)||Standard Deviation|Mean
787885|NCT00851721|Secondary|Annualized Bleeding Rate for New Target Joints|Target joints are ≥4 bleeds/6 months in any one of the following joints: ankles, knees, elbows, and hips; a target joint bleeding episode refers to an individual anatomical location.|12 months ± 14 days|"Efficacy Intent to Treat Analysis Dataset:
Dataset consists of data from all randomized participants. Dataset includes those who discontinued FEIBA NF but did not withdraw informed consent and were willing to continue providing data. For these participants, only the data collected before FEIBA NF discontinuation is included."||Bleeds per year||Inter-Quartile Range|Median
787886|NCT00851721|Secondary|Differences in Mean Transformed Annualized Bleeding Rate Between On-Demand and Prophylaxis Treatment Regimens by Bleeding Etiology, and Bleeding Type|"Annualized bleed rates were transformed using the square root of the number of bleeding episodes observed (X bleeds/year), X′ = √(X + 0.5). This transformation was performed to stabilize the variance and align the sample distribution with the assumption of normality inherent in using the t-test.
The difference in mean transformed ABRs was used to perform statistical tests and generate p-values at a significance level of 5%
Participants were Randomized to Receive 1 of the 2 Following Treatment Regimens:
On-Demand: FEIBA NF dose & dosing interval as prescribed by treating physician
Prophylaxis: 85 ± 15 U/kg of FEIBA NF every other day during 12-month prophylactic period"|12 months ± 14 days|Efficacy Intent to Treat Analysis Dataset||(bleeds/year)^(1/2)||Standard Deviation|Mean
787887|NCT00851721|Secondary|Annualized Bleeding Rate by Treatment Regimen, Bleeding Etiology, and Bleed Type|Spontaneous includes unknown/undermined etiology|12 months ± 14 days|"Efficacy Intent to Treat Analysis Dataset:
Dataset consists of data from all randomized participants. Dataset includes those who discontinued FEIBA NF but did not withdraw informed consent and were willing to continue providing data. For these participants, only the data collected before FEIBA NF discontinuation is included."||Bleeds per year||Inter-Quartile Range|Median
787888|NCT00851721|Primary|Reduction in Annualized Bleeding Episode Rate (ABR) Among Participants Receiving Prophylactic Treatment as Compared to Those Treated On-demand|"Participants were Randomized to Receive 1 of the 2 Following Treatment Regimens:
On-Demand: FEIBA NF dose & dosing interval as prescribed by treating physician
Prophylaxis: 85 ± 15 U/kg of FEIBA NF every other day during 12-month prophylactic period
Annualized rate of bleeding episodes was calculated as:
(Number of bleeding episodes/observed treatment period in days) * 365.25"|12 months ± 14 days|"Efficacy Intent to Treat Analysis Dataset:
Dataset consists of data from all randomized participants. Dataset includes those who discontinued FEIBA NF but did not withdraw informed consent and were willing to continue providing data. For these participants, only the data collected before FEIBA NF discontinuation is included."||bleeds/year||Inter-Quartile Range|Median
787889|NCT00851786|Secondary|VZV-specific Cellular Immune Responses by Intracellular Cytokine Staining and/or ELISPOT Assays in the First 40 Subjects Entering in Each CD4 Stratum at the Opening of Stage II||Within 6 weeks following one or two doses of ZOSTAVAX||||||
787890|NCT00851786|Secondary|VZV Antibodies as Measured by gpELISA|VZV antibody titer measured by gpELISA after one or two doses of ZOSTAVAX/placebo|Within 6 weeks following one or two doses of ZOSTAVAX|Subjects with both baseline gpELISA result and at least one post vaccination gpELISA result available||log gpELISA antibody titer||Standard Deviation|Mean
787891|NCT00851786|Primary|Number of Participants With Composite Safety Endpoint of the Occurrence of Serious Adverse Events (SAEs) or Division of AIDS (DAIDS) Grade 3 and 4 Signs and Symptoms, Excluding SAEs Related to Trauma|Although the study was designed as a randomized trial, it was not powered to detect safety related differences between treatment arms. The safety of ZOSTAVAX was determined by comparing the number of subjects from the active arm who experienced safety endpoint to the number from a pre-specified decision rule, which was calculated based on a similar population and calibrated using the number of safety endpoints observed from the placebo arm. The pre-specified decision rule is that ZOSTAVAX would be considered to have acceptable safety if no more than 18 subjects experience a study-defined composite safety endpoint.|During the 6 week study period after receipt of any dose of ZOSTAVAX|Subjects who received at least one dose of study vaccine/placebo||participants|||Number
787892|NCT00851799|Secondary|Fold Change in Percent Expression of CD38+HLADR+ on CD8+ (Percent) From Study Entry to Weeks 24 and 96|Percent expression of CD38+HLADR+ on CD8+ was measured at study entry and weeks 24 and 96 (unit of measure percent). Fold change from study entry to week 24 or week 96 was calculated as (week 24 value or week 96 value) / (study entry value).|Study entry, weeks 24 and 96|Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.||Fold change||Inter-Quartile Range|Median
787893|NCT00851799|Secondary|Fold Change in Percent Expression of CD38+HLADR+ on CD4+ (Percent) From Study Entry to Weeks 24 and 96|Percent expression of CD38+HLADR+ on CD4+ was measured at study entry and weeks 24 and 96 (unit of measure percent). Fold change from study entry to week 24 or week 96 was calculated as (week 24 value or week 96 value) / (study entry value).|Study entry, weeks 24 and 96|Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.||Fold change||Inter-Quartile Range|Median
787894|NCT00851799|Secondary|Fold Change in Soluble CD163 From Study Entry to Weeks 48 and 96|Soluble CD163 was measured at study entry and weeks 48 and 96 (unit of measure ng/ml). Fold change from study entry to week 48 or week 96 was calculated as (week 48 value or week 96 value) / (study entry value). Results identified above or below the limit of quantification were imputed at the quantification limit of the respective assay.|Study entry, weeks 48 and 96|Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.||Fold change||Inter-Quartile Range|Median
787895|NCT00851799|Secondary|Fold Change in Soluble CD14 From Study Entry to Weeks 48 and 96|Soluble CD14 was measured at study entry and weeks 48 and 96 (unit of measure ng/ml). Fold change from study entry to week 48 or week 96 was calculated as (week 48 value or week 96 value) / (study entry value). Results identified above or below the limit of quantification were imputed at the quantification limit of the respective assay.|Study entry, weeks 48 and 96|Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.||Fold change||Inter-Quartile Range|Median
787896|NCT00851799|Secondary|Fold Change in Interleukin-6 (IL-6) From Study Entry to Weeks 48 and 96|IL-6 was measured at study entry and weeks 48 and 96 (unit of measure pg/ml). Fold change from study entry to week 48 or week 96 was calculated as (week 48 value or week 96 value) / (study entry value). Results identified above or below the limit of quantification were imputed at the quantification limit of the respective assay.|Study entry, weeks 48 and 96|Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.||Fold change||Inter-Quartile Range|Median
787897|NCT00851799|Secondary|Fold Change in High Sensitivity C-reactive Protein (hsCRP) From Study Entry to Weeks 48 and 96|hsCRP was measured at study entry and weeks 48 and 96 (unit of measure ug/ml). Fold change from study entry to week 48 or week 96 was calculated as (week 48 value or week 96 value) / (study entry value). Results identified above or below the limit of quantification were imputed at the quantification limit of the respective assay.|Study entry, weeks 48 and 96|Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.||Fold change||Inter-Quartile Range|Median
787910|NCT00851799|Secondary|Percent Change in Trunk Fat From Study Entry to Week 96|Trunk fat was evaluated by dual-energy x-ray absorptiometry (DXA) scans at study entry and week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100.|Study entry, week 96|Intention to treat; all eligible participants with available data were included in the analysis. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.||percent||Inter-Quartile Range|Median
787898|NCT00851799|Secondary|Fold Change in D-dimer From Study Entry to Weeks 48 and 96|D-dimer was measured at study entry and weeks 48 and 96 (unit of measure ug/ml). Fold change from study entry to week 48 or week 96 was calculated as (week 48 value or week 96 value) / (study entry value). Results identified above or below the limit of quantification were imputed at the quantification limit of the respective assay.|Study entry, weeks 48 and 96|Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.||Fold change||Inter-Quartile Range|Median
787899|NCT00851799|Secondary|Change in Fasting Insulin Level From Study Entry to Weeks 4, 24, 48 and 96|Insulin (unit of measure uIU/dL) was measured at study entry and weeks 4, 24, 48 and 96; all results reflect measures captured from participants who reported fasting for at least 8 hours prior to assessment. Change was calculated as (fasting result during at week 4, 24, 48 or 96) - (fasting result at study entry).|Study entry, weeks 4, 24, 48 and 96|Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.||uIU/dL||Inter-Quartile Range|Median
787900|NCT00851799|Secondary|Change in Fasting Glucose Level From Study Entry to Weeks 4, 24, 48 and 96|Glucose (unit of measure mg/dL) was measured at study entry and weeks 4, 24, 48 and 96; all results reflect measures captured from participants who reported fasting for at least 8 hours prior to assessment. Change was calculated as (fasting result during at week 4, 24, 48 or 96) - (fasting result at study entry).|Study entry, weeks 4, 24, 48 and 96|Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.||mg/dL||Inter-Quartile Range|Median
787901|NCT00851799|Secondary|Change in Fasting Calculated Low-density Lipoprotein Cholesterol (LDL-C) From Study Entry to Weeks 4, 24, 48 and 96|Calculated LDL-C (unit of measure mg/dL) was measured at study entry and weeks 4, 24, 48 and 96 from participants who reported fasting for at least 8 hours prior to assessment; all results were centrally laboratory tested in batch. Change in calculated LDL-C was calculated as (week 4, 24, 48 or 96 result) - (study entry result).|Study entry, weeks 4, 24, 48 and 96|Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.||mg/dL||Inter-Quartile Range|Median
787902|NCT00851799|Secondary|Change in Fasting High-density Lipoprotein Cholesterol (HDL-C) From Study Entry to Weeks 4, 24, 48 and 96|HDL cholesterol (unit of measure mg/dL) was measured at study entry and weeks 4, 24, 48 and 96 from participants who reported fasting for at least 8 hours prior to assessment; all results were centrally laboratory tested in batch. Change in HDL-C was calculated as (week 4, 24, 48 or 96 result) - (study entry result).|Study entry, weeks 4, 24, 48 and 96|Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.||mg/dL||Inter-Quartile Range|Median
787903|NCT00851799|Secondary|Change in Fasting Triglyceride (TG) From Study Entry to Weeks 4, 24, 48 and 96|Triglyceride (TG, unit of measure mg/dL) was measured at study entry and weeks 4, 24, 48 and 96 from participants who reported fasting for at least 8 hours prior to assessment; all results were centrally laboratory tested in batch. Change in TG was calculated as (week 4, 24, 48 or 96 result) - (study entry result).|Study entry, weeks 4, 24, 48 and 96|Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.||mg/dL||Inter-Quartile Range|Median
787904|NCT00851799|Secondary|Change in Fasting Total Cholesterol (TC) From Study Entry to Weeks 4, 24, 48 and 96|Total cholesterol (TC, unit of measure mg/dL) was measured at study entry and weeks 4, 24, 48 and 96 from participants who reported fasting for at least 8 hours prior to assessment; all results were centrally laboratory tested in batch. Change in TC was calculated as (week 4, 24, 48 or 96 result) - (study entry result).|Study entry, weeks 4, 24, 48 and 96|Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.||mg/dL||Inter-Quartile Range|Median
787905|NCT00851799|Secondary|Change in CD4+ T-cell Count From Study Entry to Weeks 24, 48, 96 and 144|Change was calculated as (CD4+ T-cell count at week 24, 48, 96, or 144) - (CD4+ T-cell count at study entry).|Study entry to weeks 24, 48, 96, and 144|Intention to treat; all eligible participants with available data were included. Missing data were assumed missing completely at random. Participants were analyzed per original assigned randomized treatment in ACTG A5257.||cell/mm^3||Inter-Quartile Range|Median
787906|NCT00851799|Secondary|CD4+ T-cell Count at Study Entry and Weeks 24, 48, 96 and 144|The absolute levels of CD4+ T-cell counts (cells/mm^3) measured at study entry and weeks 24, 48, 96 and 144.|Study entry, weeks 24, 48, 96 and 144|Intention to treat; all eligible participants with available data were included. Missing data were assumed missing completely at random. Participants were analyzed per original assigned randomized treatment in ACTG A5257.||cell/mm^3||Inter-Quartile Range|Median
787907|NCT00851799|Secondary|Percent Change in Subcutaneous Abdominal Fat (SAT) From Study Entry to Week 96|Subcutaneous abdominal fat (SAT) was evaluated by single slice abdominal computerized tomography scans at study entry and week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100.|Study entry, week 96|Intention to treat; all eligible participants with available data were included in the analysis. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.||percent||Inter-Quartile Range|Median
787908|NCT00851799|Secondary|Percent Change in Visceral Abdominal Fat (VAT) From Study Entry to Week 96|Visceral abdominal fat (VAT) was evaluated by single slice abdominal computerized tomography scans at study entry and week 96. The percent change was calculated as as ((week 96 value - study entry value) / study entry value)) x 100.|Study entry, week 96|Intention to treat; all eligible participants with available data were included in the analysis. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.||percent||Inter-Quartile Range|Median
787909|NCT00851799|Secondary|Percent Change in Lean Mass From Study Entry to Week 96|Lean mass was evaluated by dual-energy x-ray absorptiometry (DXA) scans at study entry and week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100.|Study entry, week 96|Intention to treat; all eligible participants with available data were included in the analysis. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.||percent||Inter-Quartile Range|Median
787911|NCT00851799|Secondary|Percent Change in Total Limb Fat From Study Entry to Week 96|Total limb fat was evaluated by dual-energy x-ray absorptiometry (DXA) scans at study entry and week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100.|Study entry, week 96|Intention to treat; all eligible participants with available data were included in the analysis. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.||percent||Inter-Quartile Range|Median
787912|NCT00851799|Secondary|Percent Change in Bone Mineral Density (BMD) of the Total Body From Study Entry to Week 96|Bone mineral density (BMD) of the total body was evaluated by dual-energy x-ray absorptiometry (DXA) scans at study entry and study week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100.|Study entry, week 96|Intention to treat; all eligible participants with available data were included in the analysis. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.||percent||Inter-Quartile Range|Median
787913|NCT00851799|Secondary|Percent Change in Bone Mineral Density (BMD) of the Lumber Spine From Study Entry to Week 96|Bone mineral density (BMD) of the lumber spine was evaluated by dual-energy x-ray absorptiometry (DXA) scans at study entry and study week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100.|Study entry, week 96|Intention to treat; all eligible participants with available data were included in the analysis. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.||percent||Inter-Quartile Range|Median
787914|NCT00851799|Secondary|Percent Change in Bone Mineral Density (BMD) of the Hip From Study Entry to Week 96|Bone mineral density (BMD) of the hip was evaluated by dual-energy x-ray absorptiometry (DXA) scans at study entry and study week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100.|Study entry, week 96|Intention to treat; all eligible participants with available data were included in the analysis. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257||percent||Inter-Quartile Range|Median
787915|NCT00851799|Secondary|Change in Absolute Flow Mediated Dilation (FMD) From Study Entry to Weeks 4, 24 and 48|The change in absolute FMD was defined as the maximum absolute FMD from the RH 60 and 90 second measurements, from study entry to weeks 4, 24, and 48 (unit of measure millimeters). All results reflect measures captured from participants who reported fasting and not smoking for at least 8 hours prior to FMD assessments.|Study entry, weeks 4, 24 and 48|Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.||mm||Standard Deviation|Mean
787916|NCT00851799|Secondary|Change in Brachial Artery Flow Mediated Dilation (FMD) From Study Entry to Weeks 4 and 48|"Brachial artery flow mediated dilation was measured by brachial artery reactivity tests. All results reflect measures captured from participants who reported fasting and not smoking for at least 8 hours prior to FMD assessments.
The change from study entry to weeks 4 and 48 in brachial artery FMD (%) was defined as the maximum FMD (%) calculated from resting heart rate (RH) 60 seconds and RH 90 seconds, relative to resting brachial artery diameter."|Study entry, weeks 4 and 48|Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.||percent||95% Confidence Interval|Mean
787917|NCT00851799|Primary|Change in Brachial Artery (BA) Flow Mediated Dilation (FMD) From Study Entry to Week 24|"Brachial artery flow mediated dilation was measured by brachial artery reactivity tests. All results reflect measures captured from participants who reported fasting and not smoking for at least 8 hours prior to FMD assessments.
The change from study entry to week 24 in brachial artery FMD (%) was defined as the maximum FMD (%) calculated from resting heart rate (RH) 60 seconds and RH 90 seconds, relative to resting brachial artery diameter."|Study entry, week 24|Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.||percent||Inter-Quartile Range|Median
787918|NCT00851799|Primary|Annual Rate of Change in Right Common Carotid Artery Intima-media Thickness (CIMT)|"Right common carotid artery intima-media thickness was measured by ultrasound scan at study entry and weeks 48, 96 and 144.
The annual rate of change in right common carotid artery intima-media thickness (CIMT) was estimated over 144 weeks from study entry using mixed effects linear regression model that adjusted for screening HIV-1 RNA level and Framingham risk score stratification factors."|Study entry, week 144|Intention to treat; all eligible participants were included in the analysis. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.||micron/year||95% Confidence Interval|Mean
787919|NCT00854308|Secondary|Duration of Overall Response||Date of initial response until date of progression or death on study. (Up to 20 months)|All randomized intent-to-treat patients. Analyses of duration of response were not performed because of the small number of patients with objective responses.|||||
787920|NCT00854308|Primary|Progression-free Survival in Patients With Met Diagnostic-Positive Tumors|"Progression-free survival (PFS) in participants with Met Diagnostic-Positive tumors as determined by immunohistochemistry.
PFS was defined as the time from randomization to the first occurrence of progression or relapse (as per Response Evaluation Criteria in Solid Tumors (RECIST 1.0) and assessed by the site radiologist or investigator) or death on study from any cause (within 30 days of last treatment)."|Time from randomization to the first occurrence of progression/relapse or death on study. (Up to 20 months)|All randomized intent-to-treat patients with Met Diagnostic-Positive tumors.||months||95% Confidence Interval|Median
787921|NCT00854308|Secondary|Percentage of Participants With Objective Response in Patients With Met Diagnostic-Positive Tumors|"Objective response (OR); partial and complete response as determined using RECIST 1.0 in patients with Met Diagnostic-Positive Tumors as determined by immunohistochemistry.
Partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter.
Complete response was defined as disappearance of all target lesions."|Start of treatment until disease progression/recurrence or death on study. (Up to 20 months)|All randomized intent-to-treat patients with Met Diagnostic-positive tumors.||Percentage of participants||95% Confidence Interval|Number
788084|NCT00855595|Secondary|Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 2|IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information).|At Week 2|FAS||Percentage of participants|||Number
787922|NCT00854308|Secondary|Percentage of Participants With Objective Response|"Objective response (partial and complete response as determined using RECIST 1.0).
Partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter.
Complete response was defined as disappearance of all target lesions."|Start of treatment until disease progression/recurrence or death on study. (Up to 20 months)|All randomized intent-to-treat patients.||Percentage of participants||95% Confidence Interval|Number
787923|NCT00854308|Primary|Progression-free Survival|Progression-free survival was defined as the time from randomization to the first occurrence of progression or relapse (as per Response Evaluation Criteria in Solid Tumors (RECIST 1.0) and assessed by the site radiologist or investigator) or death on study from any cause (within 30 days of last treatment).|Time from randomization to the first occurrence of progression/relapse or death on study. (Up to 20 months)|All randomized intent-to-treat patients.||months||95% Confidence Interval|Number
787924|NCT00854360|Secondary|Change From Baseline in Morning 24-hour Reflective Non-nasal Symptom Score Over the Two-week Treatment Period|"Participants recorded the severity of their symptoms (itching/burning eyes, tearing/watering eyes, redness of eyes and itching of ears or palate) for the past 24 hours each morning using the following scale:
0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (awareness of sign/symptom, bothersome but tolerable); 3=severe (symptoms hard to tolerate, interfere with daily activities or sleeping).
Total non-nasal symptom score (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from Baseline score indicates symptom improvement."|Baseline (Day -6 to 0) and Days 1-15 (2-week Treatment Period)|The non-nasal population included only those participants with adequate non-nasal symptoms during the Run-in Period as defined by a mean daily 24-hour reflective score of 6 or greater for the 24-hour reflective non-nasal symptom score, over the last 7 days of the Run-in Period.||units on a scale||Standard Error|Least Squares Mean
787925|NCT00854360|Secondary|Change From Baseline in Morning 24-hour Reflective Ocular Symptom Score Over the Two-week Treatment Period|"Participants recorded the severity of their symptoms (itching/burning eyes, tearing/watering eyes and redness of eyes) for the past 24 hours each morning using the following scale:
0=absent (no sign/symptoms); 1=mild (sign/symptom present, minimal awareness, easily tolerated); 2=moderate (awareness of sign/symptom, bothersome but tolerable); 3=severe (sign/symptom hard to tolerate, interfere with daily activities or sleeping).
The total ocular symptom score (sum of 3 symptom scores) ranges from 0 to 9 (worst symptoms). A negative change from Baseline score indicates symptom improvement."|Baseline (Day -6 to 0) and Days 1-15 (2-week Treatment Period)|The ocular population included only those participants with adequate ocular symptoms during the Run-in Period as defined by a mean daily 24-hour reflective score of 4 or greater for the 24-hour reflective ocular symptom score, over the last 7 days of the Run-in Period.||units on a scale||Standard Error|Least Squares Mean
787926|NCT00854360|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)|The adult RQLQ has 28 questions in 7 domains (activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional). Participants were asked to recall their experiences during the previous week and to give their responses on a 7-point scale (0 = Least severe to 6 = Extremely severe). The overall RQLQ score is the mean of all 28 responses, and ranges from 0 to 7. A negative change from Baseline score indicates symptom improvement.|Baseline and Week 2|The RQLQ population included only those participants over the age of 18 years with an impaired quality of life at Baseline as defined by a RQLQ score at the Randomization Visit of 3.0 or greater.||units on a scale||Standard Error|Least Squares Mean
787927|NCT00854360|Secondary|Change From Baseline in Morning Instantaneous Total Nasal Symptom Score (iTNSS) Over the Two-week Treatment Period|Change from Baseline in the morning patient-reported instantaneous TNSS. Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) over the past 10 minutes (prior to the assessment) in the morning on a scale from 0 (mild symptoms) to 3 (severe symptoms). The total nasal symptom score (sum of the 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from Baseline score indicates symptom improvement.|Baseline (Day -6 to 0) and Days 1-15 (2-week Treatment Period)|Intent to treat population.||units on a scale||Standard Error|Least Squares Mean
787928|NCT00854360|Secondary|Change From Baseline in Average AM and PM Instantaneous Total Nasal Symptom Score (iTNSS) Over the Two Week Treatment Period|"Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) over the 10 minutes prior to the assessment, twice daily (AM & PM) using the following scale:
0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (awareness of symptom, bothersome but tolerable); 3=severe (symptoms hard to tolerate, interfere with daily activities and/or sleeping). The total nasal symptom score (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from Baseline score indicates symptom improvement."|Baseline (Day -6 to 0) and Days 1-15 (2-week Treatment Period)|Intent to treat population.||units on a scale||Standard Error|Least Squares Mean
787929|NCT00854360|Primary|Change From Baseline in Average AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Two-week Treatment Period|"Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) over the past 12 hours twice daily (AM & PM) using the following scale:
0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (awareness of sign/symptom, bothersome but tolerable); 3=severe (sign/symptoms hard to tolerate, interfere with daily activities and/or sleeping).
The total nasal symptom score (sum of the 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from Baseline score indicates symptom improvement."|Baseline (Day -6 to 0) and Days 1-15 (2-week Treatment Period)|The Intent-to-treat population included all randomized patients who received at least one dose of randomized study medication and had at least one post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
787930|NCT00854373|Secondary|Pregnancy|Fetal heart motion by transvaginal ultrasound|6 weeks after embryo transfer|||percentage of participants|||Number
787931|NCT00854373|Secondary|Mature Oocyte Recovery Rate|Likelihood of obtaining an oocyte from a single mature-sized follicle on each ovary.|36 hours after hCG trigger|||percentage of follicles|||Number
787985|NCT00855218|Primary|Time to Progression (TTP) – Independent Radiological Review (Primary Analysis)|TTP is defined as the time (days) from randomization to radiological confirmed disease progression. Participants without progression at the time of analysis were censored at their last date of tumor evaluation.|From randomization of the first participant until 28 months later (cut-off date)|Intent-to-treat (ITT)||Days||95% Confidence Interval|Median
787932|NCT00854373|Primary|Mean Fertilization Proportion (2PN/Oocytes Collected)|Number of normally fertilized oocytes (2PNs) divided by the total number of oocytes collected (i.e., not just the number of inseminated MII oocytes). This accounted for the possibility of both an enhanced oocyte maturation and improved fertilization of the mature oocytes. This also permitted inclusion of both IVF and intracytoplasmic sperm injection (ICSI) cycles in a way that allowed for evaluation of collective fertilization rates (i.e., typically, the denominator in IVF in calculating fertilization rate is all eggs collected, but in ICSI it is calculated using only the number of MII oocytes injected).|24 hours after IVF or intracytoplasmic sperm injection (ICSI)|Intention to treat||percentage of oocytes||Standard Deviation|Mean
787933|NCT00854581|Primary|Number of Patients Who Achieved Complete Response or Partial Response According to Molecular Response Criteria|To determine the effect of valproic acid therapy on persistent clonal disease in patients in complete or stable partial remission.|3, 6 and 12 months.|||participants|||Number
787934|NCT00854581|Secondary|Overall Survival|Overall survival (OS) will be measured from the date of initiation of study treatment until date of death from any cause. In the absence of death, the follow-up will be censored at date of last contact (censored observation).|Measured from the date of initiation of study treatment until date of death from any cause.||||||
787935|NCT00854581|Secondary|Failure-free Survival|Failure-free survival (FFS) will be measured from the date of treatment initiation until date of documented disease progression, relapse after response, or death from any cause. For patients alive and free of relapse or progression, follow-up time will be censored at the last documented date of failure-free status.|measured from the date of treatment initiation until date of documented disease progression, relapse after response, or death from any cause.||||||
787936|NCT00854581|Primary|To Investigate Whether AZT Functions as an Inhibitor of NF-kB in Vivo by Analyzing Serially Collected Leukemic Samples During the First 48 Hours of Treatment With AZT Only.||3, 6 and 12 months.||||||
787937|NCT00854581|Primary|To Analyze Clones From Patients Who Relapse to Determine Whether Antiviral Escape is Associated With Expression of IRF-4, c-Rel or Other Molecular Events (p53, p16 Mutations) Including Expansion of Novel Clones.||3, 6 and 12 months.||||||
787938|NCT00854581|Primary|Presence of Minimal Residual Disease at 3 and 6 Months of Maintained Remission and at 1 Year Post Initiation of Therapy||3, 6 and 12 months.||||||
787939|NCT00854581|Primary|To Investigate Whether the Lack of IRF-4 and/or c-Rel is Associated With Response (CR or PR) to Zidovudine (AZT) and IFN Alpha-2b Therapy.||3, 6 and 12 months.||||||
787940|NCT00854594|Secondary|Attitudes Toward Healthcare Teams Scale and Subscales|A validated scale developed to assess attitudes towards teams in a healthcare setting with three subscales to assess attitudes toward team value, attitudes toward team efficiency, and attitudes towards physician's shared role on a team. Each of the 21 items is rated 1 to 6, ranging from 'Strongly Disagree' to 'Strongly Agree'. The scale was considered 'complete' for analysis among providers who answered at least 7 of the 21 items. Items were reverse-coded as specified in the subscale development publication. Averages across completed items were calculated within provider. Higher values corresponded with more positive attitudes towards teams.|22 months (post-intervention)|Providers within sites randomized to control and intervention arms were surveyed after the intervention period; 20 control arm providers and 29 intervention arm providers completed the attitude scale of the survey.||units on a scale||Standard Deviation|Mean
787941|NCT00854594|Primary|Provider Abilities Scale - Subscale From the Midwest (MW) Clinicians' Network|"Providers asked to indicate their level of confidence on an 11-point scale, with 0 indicating 'not at all confident' and 10 indicating 'extremely confident' for the following activities:
Instruct patients on home glucose monitoring
Teach foot care
Teach insulin administration
Instruct patients about diet
Help patients make changes in their diets that you have recommended
Instruct patients about regular exercise
Help patients make changes in their exercise habits that you have recommended
Identify candidates for long-acting insulin
Interpret glucose patterns
Adjust insulin in insulin-treated patients with poor glycemic control
Do you feel comfortable knowing whether to titrate basal insulin versus bolus insulin
Manage patients with poor glycemic control
Initiate insulin therapy (NPH or insulin glargine and aspart)
Apply principles of diabetes care in a team setting
Averages of provider efficacy were calculated across all activities."|22 months (post-intervention)|Providers within sites randomized to control and intervention arms were surveyed after the intervention period; 20 control arm providers and 29 intervention arm providers completed the ability items of the survey.||units on a scale||Standard Deviation|Mean
787942|NCT00854594|Primary|Provider Abilities Scale - Subscale From the Midwest (MW) Clinicians' Network|"Providers asked to indicate their level of confidence on an 11-point scale, with 0 indicating 'not at all confident' and 10 indicating 'extremely confident' for the following activities:
Instruct patients on home glucose monitoring
Teach foot care
Teach insulin administration
Instruct patients about diet
Help patients make changes in their diets that you have recommended
Instruct patients about regular exercise
Help patients make changes in their exercise habits that you have recommended
Identify candidates for long-acting insulin
Interpret glucose patterns
Adjust insulin in insulin-treated patients with poor glycemic control
Do you feel comfortable knowing whether to titrate basal insulin versus bolus insulin
Manage patients with poor glycemic control
Initiate insulin therapy (NPH or insulin glargine and aspart)
Apply principles of diabetes care in a team setting
Averages of provider efficacy were calculated across all activities."|Baseline|Providers within sites randomized to control and intervention arms were surveyed at baseline; 39 control arm providers and 55 intervention arm providers completed the ability items of the survey.||units on a scale||Standard Deviation|Mean
787943|NCT00854594|Secondary|Attitudes Toward Healthcare Teams Scale and Subscales|A validated scale developed to assess attitudes towards teams in a healthcare setting with three subscales to assess attitudes toward team value, attitudes toward team efficiency, and attitudes towards physician's shared role on a team. Each of the 21 items is rated 1 to 6, ranging from 'Strongly Disagree' to 'Strongly Agree'. The scale was considered 'complete' for analysis among providers who answered at least 7 of the 21 items. Items were reverse-coded as specified in the subscale development publication. Averages across completed items were calculated within provider. Higher values corresponded with more positive attitudes towards teams.|Baseline|Providers within sites randomized to control and intervention arms were surveyed at baseline; 39 control arm providers and 53 intervention arm providers complete the attitude scale of the survey.||units on a scale||Standard Deviation|Mean
787986|NCT00855309|Primary|Number of Participants Experiencing Incidence of Nephrotoxicity, Defined as a Serum Creatinine ≥ 2 Times the Patient's Baseline||24 hours|||participants|||Number
787944|NCT00854607|Secondary|Average of the Z-scores of the SLSSL Fitted to the Fungal Biomarkers GM and βDG Over the First 6 Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 12.|After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of biomarkers GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual SLSSL divided by the overall SD. The average Z-scores of the SLSSL for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.|Weeks 1 through 6|Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and had a clinical outcome determined at Week 12.||Average Z-Score||Standard Deviation|Mean
787945|NCT00854607|Secondary|Average of the Z-scores of the SLSSL Fitted to the Fungal Biomarkers GM and βDG Over the First 6 Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 6.|After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of biomarkers GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual SLSSL divided by the overall SD. The average Z-scores of the SLSSL for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.|Weeks 1 through 6|Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and had a clinical outcome determined at Week 6.||Average Z-Score||Standard Deviation|Mean
787946|NCT00854607|Secondary|Average of the Z-scores of the TWA of Fungal Biomarkers GM and βDG Over the First 6 Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 12.|After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual TWA divided by the overall SD. The average of the Z-scores of the TWA for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.|Weeks 1 through 6|Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and had a clinical outcome determined at Week 12.||Average Z-Score||Standard Deviation|Mean
787947|NCT00854607|Secondary|Average of the Z-scores of the TWA of Fungal Biomarkers GM and βDG Over the First 6 Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 6.|After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual TWA divided by the overall SD. The average of the Z-scores of the TWA for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.|Weeks 1 through 6|Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and had a clinical outcome determined at Week 6.||Average Z-Score||Standard Deviation|Mean
787948|NCT00854607|Secondary|Average of the Z-scores of the SLSSL Fitted to the Fungal Biomarkers GM and βDG Over the First Week of Treatment for R and NonR to Anti-fungal Treatment at Week 12.|After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of biomarkers GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual SLSSL divided by the overall SD. The average Z-scores of the SLSSL for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.|Week 1|Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and had a clinical outcome determined at Week 12.||Average Z-Score||Standard Deviation|Mean
787949|NCT00854607|Secondary|Average of the Z-scores of the SLSSL Fitted to the Fungal Biomarkers GM and βDG Over the First Week of Treatment for R and NonR to Anti-fungal Treatment at Week 6.|After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of biomarkers GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual SLSSL divided by the overall SD. The average Z-scores of the SLSSL for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.|Week 1|Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and had a clinical outcome determined at Week 6.||Average Z-Score||Standard Deviation|Mean
787950|NCT00854607|Secondary|Average of the Z-scores of the TWA of Fungal Biomarkers GM and βDG Over the First Week of Treatment for R and NonR to Anti-fungal Treatment at Week 12.|After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual TWA divided by the overall SD. The average of the Z-scores of the TWA for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.|Week 1|Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and had a clinical outcome determined at Week 12.||Average Z-Score||Standard Deviation|Mean
787987|NCT00855335|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Up to follow up period (16 weeks after postpartum)|Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication.||Participants|||Number
787951|NCT00854607|Secondary|Average of the Z-scores of the TWA of Fungal Biomarkers GM and βDG Over the First Week of Treatment for R and NonR to Anti-fungal Treatment at Week 6.|After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual TWA divided by the overall SD. The average of the Z-scores of the TWA for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.|Week 1|Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and had a clinical outcome determined at Week 6.||Average Z-Score||Standard Deviation|Mean
787952|NCT00854607|Secondary|Average of the Z-scores of %CFB of Fungal Biomarkers GM and βDG Over the First Two Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 12.|After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for biomarker analysis of GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual %CFB divided by the overall SD. The average of the Z-scores of the %CFB for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.|Weeks 1 and 2|Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and had a clinical outcome determined at Week 12.||Average Z-Score||Standard Deviation|Mean
787953|NCT00854607|Secondary|Average of the Z-scores of the TWA of the CFB of Fungal Biomarkers GM and βDG Over the First Two Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 12.|After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual TWA CFB divided by the overall SD. The average of the Z-scores of the TWA CFB for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.|Weeks 1 and 2|Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and had a clinical outcome determined at Week 12.||Average Z-Score||Standard Deviation|Mean
787954|NCT00854607|Secondary|Average of the Z-scores of the SLSSL Fitted to the Fungal Biomarkers GM and βDG Over the First Two Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 12.|After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for biomarker analysis of GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual SLSSL divided by the overall SD. The average Z-scores of the SLSSL for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.|Weeks 1 and 2|Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and had a clinical outcome determined at Week 12.||Average Z-Score||Standard Deviation|Mean
787955|NCT00854607|Secondary|Average of the Z-scores of the Percent Changes From Baseline (%CFB) of Fungal Biomarkers GM and βDG Over the First Two Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 6.|After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for biomarker analysis of GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual %CFB divided by the overall SD. The average of the Z-scores of the %CFB for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.|Weeks 1 and 2|Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and had a clinical outcome determined at Week 6.||Average Z-Score||Standard Deviation|Mean
787956|NCT00854607|Secondary|Average of the Z-scores of the TWA of the Changes From Baseline (CFB) of Fungal Biomarkers GM and βDG Over the First Two Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 6.|After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual TWA CFB divided by the overall SD. The average of the Z-scores of the TWA CFB for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.|Weeks 1 and 2|Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and had a clinical outcome determined at Week 6.||Average Z-Score||Standard Deviation|Mean
787957|NCT00854607|Secondary|Average of the Z-scores of the Slopes of Least-Squares Straight Lines (SLSSL) Fitted to the Fungal Biomarkers GM and βDG Over the First Two Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 6.|After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of biomarkers GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual SLSSL divided by the overall SD. The average Z-scores of the SLSSL for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.|Weeks 1 and 2|Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and had a clinical outcome determined at Week 6.||Average Z-Score||Standard Deviation|Mean
787988|NCT00855335|Secondary|Number of Infants With Human Immunodeficiency Virus (HIV) Positive Test Result|The infants were evaluated for HIV positive tests using HIV polymerase chain reaction test (PCR).|Birth to age 16 weeks|Infants population whose mothers were included in Intent-to-treat (ITT) analysis set and who were enrolled in this study and took at least one dose of study medication. 'N' signifies number of infants who were born and had HIV test data available.||infants|||Number
787958|NCT00854607|Primary|Average of the Z-scores of the Time-Weighted Averages (TWA) of Fungal Biomarkers Galactomannan (GM) and (1,3)-β-D-glucan (βDG) Over the First Two Weeks of Treatment for Responders (R) and Non-Responders (NonR) to Anti-fungal Treatment at Week 6.|After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for biomarker analysis of GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual TWA divided by the overall standard deviation (SD). The average of the Z-scores of the TWA for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.|Weeks 1 and 2|Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and whose clinical outcome was determined at Week 6.||Average Z-Score||Standard Deviation|Mean
787959|NCT00854620|Primary|Time-to-progression (TTP)||12 months|||months||Full Range|Median
787960|NCT00854724|Primary|Amount of Alcohol Consumed||During a 90 minute drinking session|||Number of drinks consumed||Standard Error|Mean
787961|NCT00854906|Secondary|Ocular Surface Disease Index (OSDI) Questionnaire|The Ocular Surface Disease Index (OSDI) is a validated 12-item questionnaire used in dry eye studies. The OSDI Scale ranges from 0= Normal to 100= Severe. Subcategories include problems--all of the time, most of the time, half of the time,and none of the time.|1 week|By comparing the KTBUT and the FTBUT to the Ocular Surface Disease Index (OSDI) questionnaire score of each participant, we will be able to evaluate the difference in tear break up time using these items. The OSDI was given once before the participant's KTBUT and FTBUT was measured.||participants||Standard Deviation|Mean
787962|NCT00854906|Primary|Difference Between Keratometric Tear Break Up Time (KTBUT) and Fluorescein Tear Break Up Time (FTBUT)|This outcome measures the difference in tear break up time using a keratometer and fluorescein dye.|1 day|The number of participants for analysis was determined if each participant met all of the study protocol's inclusion and exclusion criteria. KTBUT and FTBUT were measured on all study participants.||time in seconds|Participants|Standard Deviation|Mean
787963|NCT00855062|Secondary|24-week Change of Center for Epidemiologic Studies Depression (CES-D) Score|"The outcome is the total CES-D score at week 24 - the total CES-D score at baseline.
The total CES-D score is based on 20 CES-D items, such as I was bothered by things that usually don't bother me and I did not feel like eating, my appetite was poor. Patients were asked to answer each item by 4 scales: (1) Rarely, (2) Sometimes, (3) Occasionally, and (4) Most of the time. After 4 negative items were multiplied by -1, the total CES-D score is a simple sum of all items.
The min and Max are 0 and 60, respectively. Higher scores indicate more severe depressive symptoms."|At baseline and week 24|The analysis includes participants with CES-D scores at baseline and week 24.||scores on a scale||Standard Deviation|Mean
787964|NCT00855062|Secondary|24-week Change of HIV RNA Plasma Viral Loads (Log10 Transformed)|The outcome is the HIV RNA plasma viral loads (Log10 transformed) at week 24 - the viral loads (Log10 transformed) at baseline.|At baseline and week 24|The analysis includes participants with HIV RNA viral loads at baseline and week 24.||copies/mL||Inter-Quartile Range|Median
787965|NCT00855062|Secondary|24-week Change of Instrumental Activities of Daily Living|The outcome is a new dichotomous variable: no change/worse vs. better at 24 weeks compared to baseline.|At baseline and week 24|The analysis includes participants with IADL scores at baseline and week 24.||percentage of participants|||Number
787966|NCT00855062|Secondary|48-week Change of CD4 Cell Counts|The outcome is defined as CD4 cell count at week 48 - CD4 cell count at baseline. The unit is cells/mm^3.|At baseline and week 48|This analysis used the participants with CD4 cell counts at baseline and week 48.||cells/mm^3||Standard Deviation|Mean
787967|NCT00855062|Secondary|24-week Change of CD4 Cell Counts|The outcome is defined as CD4 cell count at week 24 - CD4 cell count at baseline. The unit is cells/mm^3.|At baseline and week 24|This analysis used the participants with CD4 cell counts at baseline and week 24.||cells/mm^3||Standard Deviation|Mean
787968|NCT00855062|Secondary|Time From Treatment Initiation to the Development of a Grade ≥ 2 Toxicity and/or Sign and Symptoms|The outcome is the time of first Grade ≥ 2 toxicity and/or sign and symptoms from treatment initiation up to 48 weeks. The grade was determined by clinicians and an Grade ≥ 2 event means moderate, severe, life-threatening, or death event.|Time of first Grade ≥ 2 toxicity and/or sign and symptom event up to 48 weeks|This analysis includes every randomized participants. A total of 22 minocycline and 21 placebo participants reported at least one Grade ≥ 2 toxicity and/or sign and symptoms during 48 weeks.||participants with an event|||Number
787969|NCT00855062|Secondary|Time From Treatment Initiation to the Development of a Grade ≥ 2 Toxicity and/or Sign and Symptoms.|The outcome is the time to first Grade ≥ 2 toxicity and/or sign and symptoms from study treatment initiation up to week 24. The grade was determined by clinicians and an Grade ≥ 2 event means moderate, severe, life-threatening, or death event.|Time of initial Grade ≥ 2 toxicity and/or sign and symptom event up to week 24|This analysis includes every randomized participants. A total of 21 minocycline and 20 placebo participants reported at least one Grade ≥ 2 toxicity and/or sign and symptoms during 24 weeks||participants with an event|||Number
787970|NCT00855062|Secondary|24-week Change of Karnofsky Performance Score|The outcome is a new dichotomous variable: no change/worse vs. better at 24 weeks compared to baseline.|At baseline and week 24|This analysis includes the participants with Karnofsky performance score at baseline and week 24.||percentage of participants|||Number
787971|NCT00855062|Secondary|24-week Change of Memorial Sloan Kettering (MSK) HIV Dementia Stage|The outcome is a new dichotomous variable: no change/worse vs. better at 24 weeks compared to baseline.|At baseline and week 24|The descriptive statistics were based on observed data. Since all participants reported there were no change in the MSK score at week 24, no statistical test was conducted.||participants|||Number
787989|NCT00855335|Secondary|Plasma Concentration of Drug in the Cord Plasma and Maternal Plasma Samples Collected at the Time of Delivery|The drug concentrations were evaluated in the cord plasma and maternal plasma samples collected at the time of delivery.|On day of delivery - Intrapartum (Visit 6)|Population analyzed included participants who received at least one dose of study drug with one PK blood sample available. Arms were created to report data separately for the treatments. Here ‘N’ signifies number of participants evaluable for this outcome measure and n signifies number of participants evaluable for specific categories in each arm.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
787972|NCT00855062|Primary|24-week Change of Uganda Neuropsychological Test Battery Summary Measure (U NP Sum)|"The U NP Sum is defined as the average of z scores for 9 neuropsychological test subcomponents in the neuropsychological test battery (i.e. the average of norm-adjusted (z) scores for Grooved Pegboard Dominant Hand, Grooved Pegboard Non-dominant Hand, Color Trails 1, Color Trails 2, Symbol Digit, WHO-UCLA Verbal Learning test Trial 5, WHO-UCLA Verbal Learning test delayed recall, Digit Span forward and Digit Span backward). The outcome is defined as U NP Sum at week 24 - U NP Sum at baseline."|At baseline and week 24|The descriptive statistics are based on per protocol analysis. For the statistical analysis, ITT analysis was used and the missing U NP Sums at week 24 were imputed using a multiple regression imputation method. The number of participants analyzed for the ITT analysis was 73 (36 for Minocycline and 37 for Placebo).||z-score||Standard Deviation|Mean
787973|NCT00855166|Other Pre-specified|Adjusted Percent Change in Bone Mineral Density (BMD) at Total Hip|To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 102 weeks of double-blind treatment on Bone Mineral Density at total hip as measured by Dual Energy X-ray Absorptiometry.|Baseline to Week 102|Safety Analysis Set (all participants who received at least one dose of double-blind study medication)||Percent||95% Confidence Interval|Least Squares Mean
787974|NCT00855166|Other Pre-specified|Adjusted Percent Change in Bone Mineral Density (BMD) at Femoral Neck|To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 102 weeks of double-blind treatment on Bone Mineral Density at femoral neck as measured by Dual Energy X-ray Absorptiometry.|Baseline to Week 102|Safety Analysis Set (all participants who received at least one dose of double-blind study medication)||Percent||95% Confidence Interval|Least Squares Mean
787975|NCT00855166|Other Pre-specified|Adjusted Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-4)|To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 102 weeks of double-blind treatment on Bone Mineral Density at lumbar spine (L1-4) as measured by Dual Energy X-ray Absorptiometry.|Baseline to Week 102|Safety Analysis Set (all participants who received at least one dose of double-blind study medication)||Percent||95% Confidence Interval|Least Squares Mean
787976|NCT00855166|Secondary|Proportion of Participants With Body Weight Decrease ≥5%|To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 24 weeks of double-blind treatment on body weight decrease ≥5%. Least Squares Mean represents the percent of participants adjusted for body weight baseline value.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values||Percentage of participants||95% Confidence Interval|Least Squares Mean
787977|NCT00855166|Secondary|Adjusted Mean Change in Body Fat Mass|To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 24 weeks of double-blind treatment on total body fat mass measured by dual energy X-ray absorptiometry.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values||kg||95% Confidence Interval|Least Squares Mean
787978|NCT00855166|Secondary|Adjusted Mean Change in Waist Circumference|To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 24 weeks of double-blind treatment on waist circumference.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values||cm||95% Confidence Interval|Least Squares Mean
787979|NCT00855166|Primary|Adjusted Mean Change in Total Body Weight|To evaluate the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin on total body weight after 24 weeks of oral administration of double-blind treatment.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values||kg||95% Confidence Interval|Least Squares Mean
787980|NCT00855218|Secondary|Tumor Response – Investigator Assessment|Tumor Response was defined as the number of participants with a confirmed Complete Response (CR)=disappearance of all clinical and radiological tumor lesions, Partial Response (PR)= at least 30% decrease in sum of the longest diameters (LD) of tumor lesions, Stable Disease (SD)= neither sufficient shrinkage to qualify for PR nor sufficient increase for progressive disease, or Progressive Disease (PD)=at least 20% increase in the sum of LD of measured lesions, observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.|From randomization of the first participant until 28 months later (cut-off date)|Intent-to-treat (ITT)||Participants|||Number
787981|NCT00855218|Secondary|Tumor Response - Independent Radiological Review|Tumor Response was defined as the number of participants with a confirmed Complete Response (CR)=disappearance of all clinical and radiological tumor lesions, Partial Response (PR)= at least 30% decrease in sum of the longest diameters (LD) of tumor lesions, Stable Disease (SD)= neither sufficient shrinkage to qualify for PR nor sufficient increase for progressive disease, or Progressive Disease (PD)=at least 20% increase in the sum of LD of measured lesions, observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.|From randomization of the first participant until 28 months later (cut-off date)|Intent-to-treat (ITT)||Participants|||Number
787982|NCT00855218|Secondary|Time to Vascular Invasion/Extrahepatic Spread (TTVI/ES)|Time to vascular invasion/extrahepatic spread (TTVI/ES) was defined as the time (days) from randomization to vascular invasion/extrahepatic spread. Participants without vascular invasion/extrahepatic spread at the time of analysis were censored at their last date of tumor evaluation.|From randomization of the first participant until 28 months later (cut-off date)|Intent-to-treat (ITT)||Days||95% Confidence Interval|Median
787983|NCT00855218|Secondary|Time to Untreatable Progression (TTUP)|Time to untreatable progression (TTUP) was defined as the time (days) from randomization to untreatable progression. Participants without untreatable progression at the time of analysis were censored at their last date of tumor evaluation.|From randomization of the first participant until 28 months later (cut-off date)|Intent-to-treat (ITT)||Days||95% Confidence Interval|Median
787984|NCT00855218|Secondary|Overall Survival (OS)|Overall Survival (OS) was defined as the time (days) from randomization to death due to any cause. Participants still alive at the time of analysis were censored at their last date of last contact.|From randomization of the first participant until 28 months later (cut-off date)|Intent-to-treat (ITT)||Days||95% Confidence Interval|Median
788000|NCT00855439|Other Pre-specified|Intra-epidermal Nerve Fiber Density|Exploratory endpoint: Regeneration of intra-epidermal nerve fibers after denervation by capsiacin.|12 months|Subset of study population||nerve fibers per mm of skin||Standard Deviation|Mean
787990|NCT00855335|Secondary|Number of Participants With Resistance at Virological Failure|Resistance analysis was determined using genotypic and phenotypic analysis at the time of virological failure. For participants with a baseline viral load greater than (>) 200 copies/mL, virologic failure was defined as follows: HIV ribonucleic acid (RNA) levels that did not fall by at least 0.5 log 4 weeks after Baseline; viral load >1000 copies/mL (at 2 successive visits) by gestational weeks 34-38; or viral load >200 copies/mL (at 2 successive visits) after reaching a viral load less than or equal to (<=) 200 copies/mL. For participantss with a baseline viral load <=200 copies/mL, virologic failure was defined as viral load of >200 copies/mL (at 2 successive visits) at any point during the study.|Up to follow-up phase (16 weeks after postpartum)|Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication.||Participants|||Number
787991|NCT00855335|Secondary|Mean Change From Baseline in CD4+ Cell Count|Mean Change From Baseline in CD4+ Cell Count were assessed for immunology testing.|Baseline, 4 weeks after baseline, 2nd and 3rd trimesters of pregnancy and postpartum (2-5 weeks and 6-12 weeks)|Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. Here 'N' signified number of participants evaluated for this outcome measure and 'n' signifies number of participants who were evaluable at each specific timepoint for each arm respectively.||10^6 Cells/Liter||Standard Error|Mean
787992|NCT00855335|Secondary|Mean Change From Baseline in Log10 Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Viral Load Value|Mean change from baseline in log 10 HIV-1 RNA VL was assessed up to postpartum (6-12 weeks).|Baseline, 4 weeks after baseline, 2nd and 3rd trimesters of pregnancy and postpartum (2-5 weeks and 6-12 weeks)|Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. Here ‘N’ signifies number of participants evaluable for this outcome measure and 'n' signifies number of participants who were evaluable at each specific timepoint for each arm respectively.||Log 10 copies per milliliter (copies/mL)||Standard Error|Mean
787993|NCT00855335|Secondary|Number of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Plasma Viral Load (<) 50 Copies/Milliliter (mL)|Number of participants were assessed with a viral load (VL) lesser than (<) 50 HIV-1 RNA copies/ mL over time.|Up to postpartum (6-12 weeks)|Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. Here ‘N’ signifies number of participants evaluable for this outcome measure.||Participants|||Number
787994|NCT00855335|Primary|Area Under the Plasma Concentration-Time Curve From Time of Administration to 24 Hours Post-dose (AUC0-24h)|The AUC (0-24) is the area under the plasma concentration-time curve from time zero to 24 hours post dose. The selected arms were based on the dosing frequency (once daily).|Predose, 1, 2, 3, 4, 6, 9, 12, and 24 hours postdose at Weeks 24-28 (Visit 4, 2nd trimester), 34-38 (visit 5, 3rd trimester) and 6-12 weeks postpartum (visit 8)|Population analyzed included participants who received at least one dose of study drug with one PK blood sample available. Arms were created to report data separately for the treatments. Here ‘N’ signifies number of participants evaluable for this outcome measure and n signifies number of participants evaluable at specific timepoint for each arm.||nanogram*hour per milliliter (ng*h/mL)||Standard Deviation|Mean
787995|NCT00855335|Primary|Area Under the Plasma Concentration-Time Curve From Time of Administration to 12 Hours Post-dose (AUC0-12h)|The AUC (0-12) is the area under the plasma concentration-time curve from time zero to 12 hours post dose. The selected arms were based on the dosing frequency (twice daily).|Predose, 1, 2, 3, 4, 6, 9, 12 hours postdose at Weeks 24-28 (Visit 4, 2nd trimester), 34-38 (visit 5, 3rd trimester) and 6-12 weeks postpartum (visit 8)|Population analyzed included participants who received at least one dose of study drug with one PK blood sample available. Arms were created to report data separately for the treatments. Here ‘N’ signifies number of participants evaluable for this outcome measure and n signifies number of participants evaluable at specific timepoint for each arm.||nanogram*hour per milliliter (ng*h/mL)||Standard Deviation|Mean
787996|NCT00855335|Primary|Time to Reach the Maximum Plasma Concentration (Tmax)|The Tmax is defined as actual sampling time to reach maximum observed plasma concentration.|Predose, 1, 2, 3, 4, 6, 9, 12, and 24 hours postdose at Weeks 24-28 (Visit 4, 2nd trimester), 34-38 (visit 5, 3rd trimester) and 6-12 weeks postpartum (visit 8)|Population analyzed included participants who received at least one dose of study drug with one PK blood sample available. Arms were created to report data separately for the treatments. Here ‘N’ signifies number of participants evaluable for this outcome measure and n signifies number of participants evaluable at specific timepoint for each arm.||hour (h)||Full Range|Median
787997|NCT00855335|Primary|Maximum Plasma Concentration (Cmax)|The Cmax is the maximum observed plasma concentration.|Predose, 1, 2, 3, 4, 6, 9, 12, and 24 hours postdose at Weeks 24-28 (Visit 4, 2nd trimester), 34-38 (visit 5, 3rd trimester) and 6-12 weeks postpartum (visit 8)|Population analyzed included participants who received at least one dose of study drug with one PK blood sample available. Arms were created to report data separately for the treatments. Here ‘N’ signifies number of participants evaluable for this outcome measure and n signifies number of participants evaluable at specific timepoint for each arm.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
787998|NCT00855335|Primary|Minimum Plasma Concentration (Cmin)|The Cmin is the minimum observed plasma concentration.|Predose, 1, 2, 3, 4, 6, 9, 12, and 24 hours postdose at Weeks 24-28 (Visit 4, 2nd trimester), 34-38 (visit 5, 3rd trimester) and 6-12 weeks postpartum (visit 8)|Population analyzed included participants who received at least one dose of study drug with one PK blood sample available. Arms were created to report data separately for the treatments. Here ‘N’ signifies number of participants evaluable for this outcome measure and n signifies number of participants evaluable at specific timepoint for each arm.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
787999|NCT00855335|Primary|Predose (Trough) Plasma Concentration (C0h)|C0h is defined as the predose (trough) plasma concentration or concentration prior to study drug administration.|Predose on Weeks 24-28 (Visit 4, 2nd trimester), 34-38 (visit 5, 3rd trimester) and 6-12 weeks postpartum (visit 8)|Population analyzed included participants who received at least one dose of study drug with one PK blood sample available. Arms were created to report data separately for the treatments. Here ‘N’ signifies number of participants evaluable for this outcome measure and n signifies number of participants evaluable at specific timepoint for each arm.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
788001|NCT00855439|Secondary|Cardiac Autonomic Neuropathy|resting heart rate as marker of autonomic function at rest|18 month|||beats per minute||Standard Deviation|Mean
788003|NCT00855439|Primary|Confirmed Clinical Neuropathy (CCN)|CCN was defined by a composite score comprised of at least two positive responses among symptoms, sensory signs, or absent or hypoactive reflexes consistent with a distal symmetrical polyneuropathy (16), and at least one abnormal nerve conduction study result in two anatomically distinct nerves, e.g. the sural sensory and peroneal motor nerves (defined as a amplitude < 5 μV and a conduction velocity < 40 m/sec for the sural nerve and an amplitude < 2.5 μV and a conduction velocity < 40 m/sec for the peroneal nerve).|18 Months|||participants|||Number
788004|NCT00855465|Other Pre-specified|Mean Ventricular Rate (VRmean) - Change From Baseline to Week 16|Ventricular rate was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of ECG parameters.||beats per minute (bpm)||Standard Deviation|Mean
788005|NCT00855465|Other Pre-specified|Mean RR Duration (RRmean) - Change From Baseline to Week 16|RR duration was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position.|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of ECG parameters.||ms||Standard Deviation|Mean
788006|NCT00855465|Other Pre-specified|Mean QTcF Duration (Fridericia's Correction Formula, QTcF) - Change From Baseline to Week 16|Fridericia-corrected QTcF duration was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position.|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of ECG parameters.||ms||Standard Deviation|Mean
788007|NCT00855465|Other Pre-specified|Mean QTcB Duration (Bazett's Correction Formula, QTcB) - Change From Baseline to Week 16|Bazett-corrected QTcB duration was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position.|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of ECG parameters.||ms||Standard Deviation|Mean
788008|NCT00855465|Other Pre-specified|Mean QT Duration (QTmean) - Change From Baseline to Week 16|QT duration was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position.|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of ECG parameters.||ms||Standard Deviation|Mean
788009|NCT00855465|Other Pre-specified|Mean QRS Duration (QRSmean) - Change From Baseline to Week 16|QRS duration was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position.|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of ECG parameters.||ms||Standard Deviation|Mean
788010|NCT00855465|Other Pre-specified|Mean PR Duration (PRmean) - Change From Baseline to Week 16|PR duration was evaluated as part of the 12-lead electrocardiogram. electrocardiograms (ECGs) were recorded after the participant had been at rest for 15 minutes in a supine position.|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of ECG parameters.||ms||Standard Deviation|Mean
788011|NCT00855465|Other Pre-specified|Oxygen Saturation (SaO2) - Change From Baseline to Week 16|Oxygen saturation (SaO2) is measured as part of the capillary or arterial blood gas analysis. Normal blood oxygen saturation is considered 95-100 percent. If possible, no supplementary oxygen was given during the resting period and while blood samples were drawn.|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of blood gas parameters.||Percentage of oxygen saturation||Standard Deviation|Mean
788012|NCT00855465|Other Pre-specified|Arterial Partial Oxygen Pressure (PaO2) - Change From Baseline to Week 16|Arterial partial pressure of oxygen (PaO2) is performed as part of the capillary or arterial blood gas analysis. If possible, no supplementary oxygen was given during the resting period and while blood samples were drawn.|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of blood gas parameters.||mmHg||Standard Deviation|Mean
788013|NCT00855465|Other Pre-specified|Arterial Partial Pressure of Carbon Dioxide (PaCO2) - Change From Baseline to Week 16|Arterial partial pressure of carbon dioxide (PaCO2) is performed as part of the capillary or arterial blood gas analysis. If possible, no supplementary oxygen was given during the resting period and while blood samples were drawn.|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of blood gas parameters.||mmHg||Standard Deviation|Mean
788085|NCT00855595|Secondary|Percentage of Participants With IGA Based Patient Response at Weeks 2, 4, 6, 8 and 12 (LOCF)|IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information) / Patient response is defined as an IGA score of clear, minimal, or mild (0, 1, or 2)|Weeks 2, 4, 6, 8 and 12|FAS||Percentage of participants|||Number
788014|NCT00855465|Other Pre-specified|Triacylglycerol Lipase - Change From Baseline to Week 16|Triacylglycerol lipase is a standard clinical chemistry parameter. Normal range: 7 to 60 U/L|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.||U/L||Standard Deviation|Mean
788015|NCT00855465|Other Pre-specified|Cystatin C - Change From Baseline to Week 16|Cystatin C is a biomarker. Normal range: 0.53 to 1.01 ng/mL|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.||ng/ml||Standard Deviation|Mean
788016|NCT00855465|Other Pre-specified|Urea (BUN) - Change From Baseline to Week 16|Urea (blood urea nitrogen, BUN) is a standard clinical chemistry parameter. Normal range: 4 to 25 mg/dL|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.||mg/dL||Standard Deviation|Mean
788017|NCT00855465|Other Pre-specified|Urate - Change From Baseline to Week 16|Urate is a standard clinical chemistry parameter. Normal range: 4.0 to 8.5 mg/dL (males, 16-59 years), 3.4 to 8.7 mg/dL (males, >60 years) 2.5 to 7.5 mg/dL (females)|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.||mg/dL||Standard Deviation|Mean
788018|NCT00855465|Other Pre-specified|Potassium - Change From Baseline to Week 16|Potassium is a standard clinical chemistry parameter. Normal range: 3.5 to 5.3 mmol/L|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.||mmol/L||Standard Deviation|Mean
788019|NCT00855465|Other Pre-specified|Hematocrit - Change From Baseline to Week 16|Hematocrit is a standard clinical hematology parameter. Normal range: 40 to 52% (males), 36 to 46% (females)|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.||Volume percentage of red blood cells||Standard Deviation|Mean
788020|NCT00855465|Other Pre-specified|Hemoglobin - Change From Baseline to Week 16|Hemoglobin is a standard clinical hematology parameter. Normal range: 13.5 to 17.5 g/dL (males), 12.0 to 16.0 g/dL (females)|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.||g/dL||Standard Deviation|Mean
788021|NCT00855465|Other Pre-specified|Neutrophils - Change From Baseline to Week 16|Neutrophils is a standard clinical hematology parameter. Normal range: 1.6 to 7.4*10^9 cells/L|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.||*10^9 cells/L||Standard Deviation|Mean
788022|NCT00855465|Other Pre-specified|Lymphocytes - Change From Baseline to Week 16|Total lymphocytes is a standard clinical hematology parameter. Normal range: 1.0 to 4.0*10^9 cells/L|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.||*10^9 cells/L||Standard Deviation|Mean
788023|NCT00855465|Other Pre-specified|Leukocytes (WBC) - Change From Baseline to Week 16|Leukocytes (white blood cells, WBC) is a standard clinical hematology parameter. Normal range: 4.0 to 10.7*10^9 cells/L|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.||*10^9 cells/L||Standard Deviation|Mean
788024|NCT00855465|Other Pre-specified|Erythrocytes (RBC) - Change From Baseline to Week 16|Erythrocytes (red blood cells, RBC) is a standard clinical hematology parameter. Normal range: 4.6 to 5.8*10^12 cells/L (males), 4.1 to 5.2*10^12 cells/L (females)|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.||*10^12 cells/L||Standard Deviation|Mean
788025|NCT00855465|Other Pre-specified|Creatine Kinase (CK) - Change From Baseline to Week 16|Creatine Kinase is a standard clinical chemistry parameter. Normal range: 35 to 232 U/L (males), 26 to 145 U/L (females)|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.||U/L||Standard Deviation|Mean
788026|NCT00855465|Other Pre-specified|Creatinine Clearance - Change From Baseline to Week 16|Creatinine clearance is a standard clinical chemistry parameter. Normal range: 90 to 140 mL/min (males), 80 to 125 mL/min (females)|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.||mL/min||Standard Deviation|Mean
788091|NCT00855595|Primary|Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) at Week 2 (LOCF: Last Observation Carried Forward)|NOTE: Negative mean values represent an improvement (decrease of inflammatory lesions)|Baseline and Week 2|Full analysis set (FAS)||Inflammatory lesions||Standard Deviation|Mean
788027|NCT00855465|Other Pre-specified|Creatinine - Change From Baseline to Week 16|Creatinine is a standard clinical chemistry parameter. Normal range: 0.25 to 1.20 mg/dL (males), 0.46 to 1.00 mg/dL (females)|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.||mg/dL||Standard Deviation|Mean
788028|NCT00855465|Other Pre-specified|Bilirubin - Change From Baseline to Week 16|Bilirubin is a standard clinical chemistry parameter. Normal range: 0.1 to 1.2 mg/dL|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.||mg/dL||Standard Deviation|Mean
788029|NCT00855465|Other Pre-specified|Alkaline Phosphatase (AP) - Change From Baseline to Week 16|Alkaline phosphatase (AP) is a standard clinical chemistry parameter. Normal range: 40 to 129 U/L (males), 35 to 104 U/L (females)|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.||U/L||Standard Deviation|Mean
788030|NCT00855465|Other Pre-specified|Aspartate Aminotransferase (AST) - Change From Baseline to Week 16|Aspartate Aminotransferase (AST) is a standard clinical chemistry parameter. Normal range: 0 to 41 U/L.|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.||U/L||Standard Deviation|Mean
788031|NCT00855465|Other Pre-specified|Alanine Aminotransferase (ALT) - Change From Baseline to Week 16|Alanine Aminotransferase (ALT) is a standard clinical chemistry parameter. Normal range: 0 to 45 U/L.|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.||U/L||Standard Deviation|Mean
788032|NCT00855465|Other Pre-specified|Heart Rate (HR) - Change From Baseline to Week 16|Heart rate (HR) is a directly non-invasively measured hemodynamic parameter. Range allowed in this study at Visit 0 and/or Visit 1 before randomization: 50 -105 beats per minute (bpm) at rest.|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered.||Beats/min||Standard Deviation|Mean
788033|NCT00855465|Other Pre-specified|Diastolic Blood Pressure (DBP) - Change From Baseline to Week 16|Diastolic systemic arterial blood pressure (DBP) is a directly non-invasively measured hemodynamic parameter. Range allowed in this study at Visit 0 and/or Visit 1 before randomization: <= 110 mmHg.|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered.||mmHg||Standard Deviation|Mean
788034|NCT00855465|Other Pre-specified|Systolic Blood Pressure (SBP) - Change From Baseline to Week 16|Systolic systemic arterial blood pressure (SBP) is a directly non-invasively measured hemodynamic parameter. Range allowed in this study at Visit 0 and/or Visit 1 before randomization: 95 – 180 mmHg.|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered.||mmHg||Standard Deviation|Mean
788035|NCT00855465|Other Pre-specified|Cardiac Index (CI) - Change From Baseline to Week 16|The cardiac index (CI) is a calculated hemodynamic parameter. CI is derived from the directly measured parameters cardiac output (CO), divided by the body surface area (BSA). BSA is a calculated parameter, using the subject’s height and weight in the DuBois formula. Formula: BSA = (W [kg]*0.425)*(H [cm]*0.725)*0.007184 (m^2)|Baseline and week 16|"Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered.
Only participants with a baseline and at least one post-baseline measurement were included in the analysis of CI."||L/min/m^2||Standard Deviation|Mean
788036|NCT00855465|Other Pre-specified|Mean Pulmonary Artery Pressure (PAPmean) - Change From Baseline to Week 16|Mean pulmonary arterial pressure (PAPmean) is a directly measured hemodynamic parameter. PAPmean is recorded during a right heart catheterization.|Baseline and week 16|"Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered.
Only participants with a baseline and at least one post-baseline measurement were included in the analysis of PAPmean."||mmHg||Standard Deviation|Mean
788037|NCT00855465|Other Pre-specified|All Caused Mortality|"All cause mortality (including cardiovascular mortality) was one component of the composite endpoint time to clinical worsening."|At visit 6 (week 16)|Intent to Treat (ITT) - a randomized subject was valid for ITT analyses if at least one dose of study medication was administered.||Participants|||Number
788038|NCT00855465|Secondary|Living With Pulmonary Hypertension (LPH) Questionnaire - Change From Baseline to Week 16|The self-reported Living with Pulmonary Hypertension (LPH) questionnaire is designed to measure the effects of PH and PH-specific treatments on an individual’s quality of life. The LPH total score can range from 0 (best) to 105 (worst).|Baseline and week 16|Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered. Participants with a missing baseline were excluded from the analysis of the LPH questionnaire.||Scores on a scale||Standard Deviation|Mean
788039|NCT00855465|Secondary|EQ-5D Utility Score - Change From Baseline to Week 16|EQ-5D utility score is a Quality-of-Life participant reported outcome measure. The utility score is calculated based on five questions concerning problems with mobility, self-care, usual activities, pain/discomfort and anxiety/depression. An increase in the utility score represents an improvement in quality of life. The score ranges from -0.594 (worst answer in all five questions) to 1 (best answer in all five questions).|Baseline and week 16|Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered. Participants with a missing baseline were excluded from the analysis of the EQ5D utility score.||Scores on a scale||Standard Deviation|Mean
788491|NCT00857818|Secondary|Median Changes in Body Mass Index From Baseline||Baseline to Weeks 4, 8, and 16|Due to low enrollment, the study was terminated early. This endpoint was not analyzed because there were insufficient data to draw meaningful conclusions.|||||
788040|NCT00855465|Secondary|Borg CR 10 Scale - Change From Baseline to Week 16|"The Borg CR10 Scale is a participant reported outcome measure used in clinical diagnosis of e.g. breathlessness and dyspnea. It documents the participant's exertion during a physical test. Low values indicate low levels of exertion; high values indicate more intense exertion reported by the participant. The score ranges from 0 (Nothing at all) to 10 (“Extremely strong – Maximal”)."|Baseline and week 16|Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered.||Scores on a scale||Standard Deviation|Mean
788041|NCT00855465|Secondary|Percentage of Participants With Clinical Worsening|The combined endpoint “time to clinical worsening”, made up of the following components, defined by the first occurrence: all-cause mortality; heart/lung transplantation; rescue endarterectomy; first hospitalization due to pulmonary hypertension; start of a new pulmonary hypertension treatment; persistent worsening of 6MWD or WHO functional class due to deterioration of PH.|At week 16|Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered.||Percentage of participants|||Number
788042|NCT00855465|Secondary|World Health Organization (WHO) Functional Class - Change From Baseline to Week 16|The WHO functional assessment of pulmonary arterial hypertension ranged from functional class I (Patients with PH but without resulting limitation of physical activity) to class IV (Patients with PH with inability to carry out any physical activity without symptoms. These patients manifest signs of right-heart failure.). Changes to a lower WHO functional class resemble improvement; changes to a higher functional class resemble deterioration of PAH.|Baseline and week 16|Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered. Participants with a missing baseline were excluded from the analysis of WHO functional class.||Percentage of Participants|||Number
788043|NCT00855465|Secondary|N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) - Change From Baseline to Week 16|N-terminal pro-brain natriuretic peptide (NT-proBNP) levels in the blood are used for screening, diagnosis of acute congestive heart failure (CHF) and may be useful to establish prognosis in heart failure.|Baseline and week 16|Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one post-baseline measurement were included in the analysis of NT-proBNP.||pg/mL||Standard Deviation|Mean
788044|NCT00855465|Secondary|Pulmonary Vascular Resistance (PVR) - Change From Baseline to Week 16|The pulmonary vascular resistance (PVR) is a calculated hemodynamic parameter. PVR is derived from the directly measured parameters mean pulmonary arterial pressure (PAPmean) and pulmonary capillary wedge pressure (PCWP), divided by the cardiac output (CO). PVR and PAPmean are acquired during a right heart catheterization. CO is a calculated hemodynamic parameter, too. Formula: PVR = 80*(PAPmean - PCWP)/CO|Baseline and week 16|Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one post-baseline measurement were included in the analysis of PVR.||dyn*s*cm^-5||Standard Deviation|Mean
788045|NCT00855465|Primary|6 Minutes Walking Distance (6MWD) - Change From Baseline to Week 16|6-minute walking distance (6MWD) is a measure for the objective evaluation of a participant's functional exercise capacity.|Baseline and week 16|Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered.||Meters||Standard Deviation|Mean
788046|NCT00855582|Secondary|Change From Baseline in Uroflowmetry Parameters - Voided Volume (Vcomp) at Week 12 Endpoint|Vcomp is defined as the volume of urine voided (measures in mL using a standard calibrated flowmeter). At each visit, a uroflowmetry assessment was considered valid and the data were included in the statistical analyses only if the prevoid total bladder volume (assessed by ultrasound) was >=150 to <=550 milliliters (mL) and the voided volume (Vcomp) was >= 125 mL.|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value.||mL||Standard Deviation|Mean
788047|NCT00855582|Secondary|Change From Baseline in Uroflowmetry Parameters - Mean Urine Flow Rate (Qmean) at Week 12 Endpoint|Qmean is defined as the average urine flow rate (measured in milliliters per second [mL/second] using standard calibrated flowmeter). At each visit, a uroflowmetry assessment was considered valid and the data were included in the statistical analyses only if the prevoid total bladder volume (assessed by ultrasound) was >=150 to <=550 milliliters (mL) and the voided volume (Vcomp) was >= 125 mL.|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value.||mL/sec||Standard Deviation|Mean
788048|NCT00855582|Secondary|Change From Baseline in Uroflowmetry Parameters - Peak Urine Flow Rate (Qmax) at Week 12 Endpoint|Qmax is defined as the peak urine flow rate (measured in milliliters per second [mL/sec] using standard calibrated flowmeter). At each visit, a uroflowmetry assessment was considered valid and the data were included in the statistical analyses only if the prevoid total bladder volume (assessed by ultrasound) was >=150 to <=550 milliliters (mL) and the voided volume (Vcomp) was >= 125 mL.|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value.||mL/sec||Standard Deviation|Mean
788049|NCT00855582|Secondary|Erectile Function General Assessment Questionnaire (EF-GAQ)|The EF-GAQ consisted of two questions: (1) Has the treatment you have been taking during this study improved your erections? and (2) If yes, has the treatment improved your ability to engage in sexual activity? Each question has a Yes/No response.|12 weeks|Participants started study medication, and had non-missing data.||participants with yes response|||Number
788050|NCT00855582|Secondary|Clinician Global Impression of Improvement (CGI-I) at Week 12 Endpoint|A scale that measures clinician's rating of the total change in the patient's urinary symptoms at endpoint compared with the start of treatment. Scores range from 1 (very much better) to 7 (very much worse).The data are presented as the number of participants in each of the seven categories: very much better (1); much better (2); a little better (3); no change (4); a little worse (5); much worse (6); very much worse (7).|12 weeks|Participants started study medication, and had non-missing data.||participants|||Number
788051|NCT00855582|Secondary|Patient Global Impression of Improvement (PGI-I) at Week 12 Endpoint|A scale that measures the patient's perception of urinary symptoms at endpoint compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). The data are presented as the number of participants in each of the seven categories: very much better (1); much better (2); a little better (3); no change (4); a little worse (5); much worse (6); very much worse (7).|12 weeks|Participants started study medication, and had non-missing data.||participants|||Number
788052|NCT00855582|Secondary|Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 5|"Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 5, Were you satisfied overall with this sexual experience? Data are presented as the mean percentage of yes responses per the number of sexual attempts for a participant during a study period. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction."|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value.||percentage of yes responses||Standard Error|Least Squares Mean
788053|NCT00855582|Secondary|Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 4 at Week 12 Endpoint|"Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 4, Were you satisfied with the hardness of your erection? Data are presented as the mean percentage of yes responses per the number of sexual attempts for a participant during a study period. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction."|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value.||percentage of yes responses||Standard Error|Least Squares Mean
788054|NCT00855582|Secondary|Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 2 at Week 12 Endpoint|"Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 2, Were you able to insert your penis into your partner's vagina? Data are presented as the mean percentage of yes responses per the number of sexual attempts for a participant during a study period. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction."|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value.||percentage of yes responses||Standard Error|Least Squares Mean
788055|NCT00855582|Secondary|Change From Baseline in International Index of Erectile Function Question 4 at Week 12 Endpoint|IIEF Question 4 asks whether how often a subject was able to maintain an erection after penetration over the past 4 weeks. Scores range from 0 (did not attempt intercourse) to 5 (almost always or always). Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||units on a scale||Standard Error|Least Squares Mean
788056|NCT00855582|Secondary|Change From Baseline in International Index of Erectile Function Question 3 at Week 12 Endpoint|IIEF Question 3 asks how often a subject was able to penetrate his partner over the past 4 weeks. Scores range from 0 (did not attempt intercourse) to 5 (almost always or always). Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||units on a scale||Standard Error|Least Squares Mean
788057|NCT00855582|Secondary|Change From Baseline in International Index of Erectile Function - Intercourse Satisfaction Domain at Week 12 Endpoint|Self-reported intercourse satisfaction over the past 4 weeks. Calculated as the sum of IIEF Questions 6, 7 and 8. Each question is scored from 0 through 5 with a possible total score of 0 through 15. Higher score represent greater satisfaction. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||units on a scale||Standard Deviation|Least Squares Mean
788058|NCT00855582|Secondary|Change From Baseline in International Index of Erectile Function - Overall Satisfaction Domain at Week 12 Endpoint|Self-reported overall satisfaction over the past 4 weeks. Calculated as the sum of IIEF Questions 13 and 14. Each question is scored from 1 through 5, with a possible total score of 2 through 10. Higher scores represent greater satisfaction. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||units on a scale||Standard Deviation|Least Squares Mean
788059|NCT00855582|Secondary|Change From Baseline in International Prostate Symptom Score Quality of Life (QoL) at Week 12 Endpoint|Assessment of quality of life (QoL) by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible). Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||units on a scale||Standard Error|Least Squares Mean
788060|NCT00855582|Secondary|Change From Baseline in International Prostate Symptom Score Nocturia Question at Week 12|The IPSS Nocturia question (Question 7) measures the number of times needed to get up at night to urinate. Scores range from 0 (none) to 5 (5 or more times). Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||units on a scale||Standard Error|Least Squares Mean
788086|NCT00855595|Secondary|Percentage of Participants With Investigator’s Global Assessment (IGA) Based Therapeutic Success at Weeks 2, 4, 6, 8 and 12 (LOCF)|IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information) / Therapeutic success is defined as an IGA score of clear or minimal (0 or 1).|Weeks 2, 4, 6, 8 and 12|FAS||Percentage of participants|||Number
788061|NCT00855582|Secondary|Change From Baseline in International Prostate Symptom Score Storage (Irritative) Subscore at Week 12 Endpoint|IPSS irritative subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. The irritative subscore ranges from 0 to 15 with a higher score representing more irritative symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||units on a scale||Standard Error|Least Squares Mean
788062|NCT00855582|Secondary|Change From Baseline in International Prostate Symptom Score Voiding (Obstructive) Subscore at Week 12 Endpoint|IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. The obstructive subscore ranges from 0 to 20 with a higher score representing greater obstruction. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||units on a scale||Standard Error|Least Squares Mean
788063|NCT00855582|Secondary|Change From Baseline in BPH Impact Index (BII) at Week 4 and 8 Endpoint|The BII is a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores range from 0 to 13; higher scores represent increased perceived impact of benign prostatic hyperplasia-lower urinary tract symptoms on overall health. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 4 weeks, 8 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||units on a scale||Standard Error|Least Squares Mean
788064|NCT00855582|Secondary|Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 3 at Week 4 and Week 8 Endpoint|"Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 3, Did your erection last long enough for you to have successful intercourse? Data are presented as the mean percentage of yes responses per the number of sexual attempts for a participant during a study period. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction."|Baseline, 4 weeks, 8 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value.||percentage of yes responses||Standard Error|Least Squares Mean
788065|NCT00855582|Secondary|Change From Baseline in International Index of Erectile Function - Erectile Function (IIEF-EF) Domain at Week 4 and Week 8 Endpoint|Self-reported erectile function over the past 4 weeks. Questions 1-5 were scored from 0-5, and Question 15 from 1 to 5. Erectile Function Domain scores range from 1 to 30; lower numerical scores represent greater severity of erectile dysfunction. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 4 weeks, 8 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||units on a scale||Standard Error|Least Squares Mean
788066|NCT00855582|Secondary|Change From Baseline in International Prostate Symptom Score (IPSS) at Week 4 and Week 8 Endpoint|The total IPSS is obtained by combining the scores of the responses to component questions 1 through 7. Each question is scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 4 weeks, 8 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||units on a scale||Standard Error|Least Squares Mean
788067|NCT00855582|Secondary|Change From Baseline in Modified IPSS (mIPSS) at Week 2 Endpoint|The Modified IPSS is the total IPSS collected at 2 weeks post-baseline. The total IPSS is obtained by combining the scores of the responses to component questions 1 through 7. Each question is scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from ANCOVA. The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 2 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||units on a scale||Standard Error|Least Squares Mean
788068|NCT00855582|Secondary|Change From Baseline in BPH Impact Index (BII) at Week 12 Endpoint (2.5 mg)|The BII is a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores range from 0 to 13; higher scores represent increased perceived impact of benign prostatic hyperplasia-lower urinary tract symptoms on overall health. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||units on a scale||Standard Deviation|Least Squares Mean
788069|NCT00855582|Secondary|Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 3 at Week 12 Endpoint (2.5 mg)|"Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 3, Did your erection last long enough for you to have successful intercourse? Data are presented as the mean percentage of yes responses per the number of sexual attempts for a participant during a study period. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction."|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value.||percentage of yes responses||Standard Error|Least Squares Mean
788070|NCT00855582|Secondary|Change From Baseline in Benign Prostatic Hyperplasia (BPH) Impact Index (BII) at Week 12 Endpoint (5 mg)|The BII is a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores range from 0 to 13; higher scores represent increased perceived impact of benign prostatic hyperplasia-lower urinary tract symptoms on overall health. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||units on scale||Standard Error|Least Squares Mean
788071|NCT00855582|Secondary|Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 3 at Week 12 Endpoint (5 mg)|"Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 3, Did your erection last long enough for you to have successful intercourse? Data are presented as the mean percentage of Yes responses per the number of sexual attempts for a participant during a study period. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction."|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value.||percentage of Yes responses||Standard Error|Least Squares Mean
788072|NCT00855582|Primary|Change From Baseline in International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score at Week 12 Endpoint (2.5 mg)|Self-reported erectile function over the past 4 weeks. Questions 1-5 were scored from 0-5, and Question 15 from 1 to 5. Erectile Function Domain scores range from 1 to 30; lower numerical scores represent greater severity of erectile dysfunction. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||units on a scale||Standard Error|Least Squares Mean
788073|NCT00855582|Primary|Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12 Endpoint (2.5 mg)|The total IPSS is obtained by combining the scores of the responses to component questions 1 through 7. Each question is scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||units on a scale||Standard Error|Least Squares Mean
788074|NCT00855582|Primary|Change From Baseline in International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score at Week 12 Endpoint (5 mg)|Self-reported erectile function over the past 4 weeks. Questions 1-5 were scored from 0-5, and Question 15 from 1 to 5. Erectile Function Domain scores range from 1 to 30; lower numerical scores represent greater severity of erectile dysfunction. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||units on a scale||Standard Error|Least Squares Mean
788075|NCT00855582|Primary|Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12 Endpoint (5 mg)|The total IPSS is obtained by combining the scores of the responses to component questions 1 through 7. Each question is scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||units on a scale||Standard Error|Least Squares Mean
788076|NCT00855595|Other Pre-specified|Patient Opinion of Local Tolerability||Week 12|Participants in the FAS who took part in this evaluation.||Percentage of Participants|||Number
788077|NCT00855595|Secondary|Patient Opinion of Cosmetic Acceptability at End of Study (Week 12)||Week 12|Participants in the FAS who took part in this evaluation.||Percentage of participants|||Number
788078|NCT00855595|Secondary|Patient Rating of Overall Improvement at End of Study (Week 12)||Week 12|Participants in the FAS who took part in this evaluation.||Percentage of participants|||Number
788079|NCT00855595|Secondary|Investigator Rating of Overall Improvement at End of Study (Week 12)||Week 12|Participants in the FAS who took part in this evaluation.||Percentage of participants|||Number
788080|NCT00855595|Secondary|Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 12|IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information).|At Week 12|FAS||Percentage of participants|||Number
788081|NCT00855595|Secondary|Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 8|IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information).|At Week 8|FAS||Percentage of participants|||Number
788082|NCT00855595|Secondary|Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 6|IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information).|At Week 6|FAS||Percentage of participants|||Number
788083|NCT00855595|Secondary|Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 4|IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information).|At Week 4|FAS||Percentage of participants|||Number
788092|NCT00855738|Secondary|Percent of Participants With Cessation of Occupation, Requirement of Caregiver, or Admission to Intensive Care Unit|Percent of participants with cessation of usual occupation, requirement of an informal caregiver, and who required admission to the intensive care unit (ICU).|Month 6|FAS; LOCF.||percent of participants|||Number
788093|NCT00855738|Secondary|Change From Baseline to Month 6 in Total Number of Days Hospitalized Because of Epilepsy|Numerical assessment of change in total number of days hospitalized because of epilepsy during the study.|Baseline to Month 6|FAS; LOCF. N=number of subjects with evaluable data.||Days||Standard Deviation|Mean
788094|NCT00855738|Secondary|Change From Baseline to Month 6 in Visits to a Specialist or the Emergency Room Because of Epilepsy|Numerical assessment of change in the number of visits to a specialist or the emergency room because of epilepsy needed during the study.|Baseline to Month 6|FAS; LOCF. Costs involved in health and non-health resources needed during the study were not analyzed as planned with this endpoint. N=number of subjects with visits to a specialist because of epilepsy.||visits||Standard Deviation|Mean
788095|NCT00855738|Secondary|Percent of Participants Indicating Optimal Sleep on the Optimal Sleep Subscale: Medical Outcomes Study Sleep Scale (MOS-SS)|MOS-SS: subject rated instrument used to assess the key constructs of sleep; assesses sleep quantity and quality and is comprised of 12 items yielding 7 subscale scores and 2 composite index scores. Optimal sleep subscale is derived from sleep quantity average hours of sleep over the past 4 weeks; percent of participants with response YES (optimal) if sleep quantilty was 7-8 hours of sleep per night.|Baseline, Month 6|FAS; LOCF.||percent of participants|||Number
788096|NCT00855738|Secondary|Change in Sleep Disturbances From Baseline to Month 6: Medical Outcomes Study Sleep Scale (MOS-SS)|Subject rated instrument to assess key constructs of sleep; assesses sleep quality and quantity. Consists of a 6-item and 9-item overall sleep problems index measuring time to fall asleep and sleep duration in past 4 weeks; 5 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath, somnolence, and adequacy. Transformed scores range = 0 to 100; higher score indicates greater intensity of attribute. Two additional subscales = sleep quantity (range 0-24 hours) and optimal sleep (number of participants with optimal sleep 7-8 hours per night).|Baseline to Month 6|FAS LOCF. Change from baseline in Optimal sleep is not shown as changes from baseline were only evaluated for continuous parameters. N=number of subjects with evaluable data.||scores on scale||Standard Deviation|Mean
788097|NCT00855738|Secondary|Change From Baseline to Months 3 and 6 in Health Condition: Euro Quality of Life Scale (EQ-5D) Visual Analog Scale (VAS)|Assessment of the health condition of the subjects using the EQ-5D VAS: subject rated questionnaire to assess health-related quality of life in terms of a single index value. Using the VAS subjects rated current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.|Baseline, Month 3, Month 6|FAS LOCF. N=number of subjects with evaluable data.||scores on scale||Standard Deviation|Mean
788098|NCT00855738|Secondary|Change From Baseline to Month 6 in Quality of Life 10 Domains (QOLIE-10)|QOLIE-10: 10-item questionnaire evaluates health-related quality of life in individuals with epliepsy. Comprised of 7 components: seizure worry, overall quality of life, emotional well-being, energy, cognitive functioning, medication effects (physical and mental effects), and social function (work, driving, social function). Total score rated 0 to 100; higher score = higher quality of life.|Baseline to Month 6|FAS; LOCF. N=number of subjects with evaluable data.||scores on scale||Standard Deviation|Mean
788099|NCT00855738|Secondary|Change From Baseline to Month 6 in the Hospital Anxiety and Depression Scale (HADS)|HADS: subject rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.|Baseline to Month 6|FAS; LOCF. N=number of subjects with evaluable data.||scores on scale||Standard Deviation|Mean
788100|NCT00855738|Secondary|Percent of Participants That Reduced, Maintained and Increased the Doses of the Initial Treatment Administered in Monotherapy||Baseline through Month 6 (or end of treatment)|FAS; LOCF. N= number of subjects with initial treatment administered as monotherapy.||percent of participants|||Number
788101|NCT00855738|Secondary|Percent of Participants That Reduced, Maintained and Increased Their Doses of New Antiepileptic Drugs (AED)||Baseline to Month 6 (or end of treatment)|FAS; LOCF.||percent of participants||95% Confidence Interval|Number
788102|NCT00855738|Secondary|Percent of Participants Reaching Monotherapy|Percent of participants who started on more than one treatment (bitherapy) and reached monotherapy by end of study.|Baseline through Month 6 (or end of study)|FAS; LOCF. N=number of participants who started on bitherapy.||percent of partipants||95% Confidence Interval|Number
788103|NCT00855738|Secondary|Treatment Satisfaction Evaluated by Patient Global Impression of Change Visual Analog Scale (VAS)|Patient Global Impression of Change VAS: subject rated instrument to measure subject's change in overall status; range from 0 (much better) to 10 (much worse).|Baseline, Month 3, Month 6|FAS; LOCF. The scale for this endpoint was not collected and results were not analyzed as planned.||scores on scale||Standard Deviation|Mean
788104|NCT00855738|Secondary|Time to Discontinuation Due to Other Reasons||Baseline, Month 3, Month 6|FAS; LOCF. Due to the low number of participants who discontinued due to other reasons, the time to exit analyses was not performed.||days||Full Range|Median
788105|NCT00855738|Secondary|Time to Discontinuation Due to Safety, Tolerability, or Treatment Compliance||Baseline, Month 3, Month 6|FAS; LOCF. Due to the low number of participants who discontinued due to safety, tolerability or compliance with treatment, the time to exit analysis was not performed.||days||Inter-Quartile Range|Median
788106|NCT00855738|Secondary|Time to Discontinuation Due to Lack of Efficacy||Baseline, Month 3, Month 6|FAS; LOCF. As no participants discontinued due to lack of efficacy, the time to exit analysis was not performed.||days||Inter-Quartile Range|Median
788107|NCT00855738|Secondary|Percent of Participants Who Continued on Study Medication to Month 6|Retention rate: percent of participants who continued on study medication throughout the 6 Month period after inclusion in the study.|Baseline to Month 6|FAS; LOCF.||percent of participants|||Number
788108|NCT00855738|Secondary|Time to First Seizure|Number of days to first seizure after baseline.|Baseline to Month 6 (or end of treatment)|FAS LOCF. N=number of subjects with evaluable data.||days||Standard Deviation|Mean
788109|NCT00855738|Secondary|Percent of Days Without Crisis During the Study|Crisis was defined as the total number of seizures during the study, the seizures at month 3 plus the seizures at month 6. The percent of days without crisis is number of days of study (date of last visit minus date of baseline visit) without crisis divided by number of days of study, multiplied by 100.|Baseline through Month 6 (or end of treatment)|The percentage of days without crisis during the study was not evaluable because a diary with the daily number of crises was not collected.||percentage of days|||Number
788110|NCT00855738|Secondary|Percent Change From Baseline in the Median Number of Seizures During the Last 3 Months of Treatment||Baseline, Month 3, Month 6 (last 3 months of treatment)|FAS LOCF. N=number of subjects with evaluable data.||percent change||Inter-Quartile Range|Median
788111|NCT00855738|Secondary|Percent of Seizure-free Participants During the Last 3 Months Before Discontinuation||Baseline, Month 3, Month 6 (last 3 months of treatment)|FAS; LOCF. N=number of subjects with evaluable data.||percent of participants||95% Confidence Interval|Number
788112|NCT00855738|Secondary|Percent of Participants With Reduction in Number of Seizures >=25% and >=75% During the Last 3 Months of Treatment|Percent of participants with reduction in number of seizures >=25% and >=75% during the last 3 months of treatment before discontinuation (assessed at Month 3 and Month 6) versus the 3 month period before the baseline visit.|Baseline, Month 3, Month 6 (last 3 months of treatment)|FAS; LOCF. N=number of subjects with evaluable data.||percent of participants||95% Confidence Interval|Number
788113|NCT00855738|Primary|Percent of Participants Classified as Responders|Responder = decrease in number of seizures by >=50 percent (%) during the last 3 months of treatment before discontinuation (assessed at Month 3 and Month 6) versus the number of seizures that occurred during the 3 months before the baseline visit (baseline).|Baseline, Month 3, Month 6 (last 3 months of treatment)|Full Analysis Set (FAS): intent-to-treat population = those who took at least 1 dose of study medication and had post-baseline data for at least 1 efficacy endpoint. Last Observation Carried Forward (LOCF) captures last 3 months of treatment for subjects who discontinued between Month 3 and Month 6 only. N=number of subjects with evaluable data.||percent of participants||95% Confidence Interval|Number
788114|NCT00855816|Primary|Change Scores for Criteria D Items on the CAPS Structured Clinical Interview|"Change in total score for all criterion D items on the Clinician-Administered PTSD Scale for DSM-IV, from baseline to post-treatment.
Total Criterion D subscore = sum of all frequency (0-4) and intensity (0-4) ratings of 5 PTSD hyperarousal symptoms.
Range: 0 to 40, with higher scores indicating more severe (frequent and/or intense) symptoms.
Change score calculated as: CAPS D score time 2 - CAPS D score time 1. Greater negative change scores indicate greater reduction in symptom severity (aka symptom improvement)."|Baseline and 8 weeks|||units on a scale||Standard Deviation|Mean
788115|NCT00855842|Primary|Length of Medical Abortion|This is the time elapsed from the first dose of misoprostol (the agent to induce abortion) and expulsion of the fetus|hours since the start of medical abortion|||hours||Standard Deviation|Mean
788116|NCT00855868|Primary|Differences in Standard Uptake Value Ratio (SUVR) for Frontal Cortex/Cerebellum and Whole Brain/Cerebellum of the Positron Emission Tomography (PET) Scan With [18F]-AV-45 for Probable Alzheimer's Disease (AD) Versus Cognitively Normal Subjects.|Standardized Uptake Value ratio (SUVR) as measured in this study indicates the ratio of tracer uptake in the frontal cortex relative to the cerebellum or the ratio of tracer uptake in the whole brain relative to the cerebellum.|28 d|||SUVR||Standard Deviation|Mean
788117|NCT00855894|Secondary|Percentage of Patients With Disease Control (DC) at Day 56|DC was defined as a CR, a PR, or stable disease (SD) as determined by the investigator and based on CT using RECIST. A CR was defined as the disappearance of all target (TL) and non-target lesions (nTL). A PR was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline sum longest diameter, or the persistence of 1 or more nTLs and/or maintenance of a tumor marker level (TML) above normal limits. For TLs, SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum longest diameter (SSLD) since treatment started. For nTLs, SD was defined as the persistence of 1 or more lesions and/or maintenance of a TML above normal limits. PD was defined as ≥ 20% increase in the SLD of TLs, taking as reference the SSLD recorded since treatment started, the appearance of 1 or more new lesions, or the unequivocal progression of existing nTLs.|Baseline to Day 56|All 41 patients treated with erlotinib and pertuzumab.||Percentage of patients||95% Confidence Interval|Number
788118|NCT00855894|Secondary|Percentage of Patients With an Objective Response (OR)|OR was defined as a complete response (CR) or a partial response (PR) as determined by the investigator and based on computed tomography (CT) using Response Evaluation Criteria in Solid Tumors (RECIST) on 2 consecutive occasions at least 4 weeks apart. A complete response was defined as the disappearance of all target and non-target lesions and normalization of tumor marker level. A partial response was defined as ≥ 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter, or the persistence of 1 or more non-target lesions and/or the maintenance of a tumor marker level above the normal limits.|Baseline to the end of the study (up to 3 years)|All 41 patients treated with erlotinib and pertuzumab.||Percentage of patients||95% Confidence Interval|Number
788119|NCT00855894|Secondary|Overall Survival (OS)|Overall survival was defined as the time from the date of first dosing with pertuzumab and erlotinib until the date of patient death from any cause.|Baseline to the end of the study (up to 3 years)|All 41 patients treated with erlotinib and pertuzumab. Patients who had not died at the time of analysis for OS were censored at the date of last contact.||Months||95% Confidence Interval|Median
788130|NCT00855959|Secondary|Night-time Awakenings Due to Asthma Symptoms|Change in Night-time awakenings due to asthma symptoms from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)|6 weeks|||awakenings||Standard Deviation|Mean
788131|NCT00855959|Secondary|Use of Rescue Medication (Total)|Change in Use of rescue medication (Total) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)|6 weeks|||puffs||Standard Deviation|Mean
788132|NCT00855959|Secondary|Use of Rescue Medication (Night-time)|Change in Use of rescue medication (Night-time) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)|6 weeks|||puffs||Standard Deviation|Mean
788120|NCT00855894|Secondary|Progression-free Survival (PFS)|PFS was defined as the time from the first dosing with pertuzumab and erlotinib to the first occurrence of disease progression (PD), as determined by the investigator and based on computed tomography using Response Evaluation Criteria in Solid Tumors (RECIST), or death from any cause, whichever comes first. PD was defined as ≥ 20% increase in the sum of the longest diameter of target lesions (TL), taking as reference the smallest sum longest diameter recorded since treatment started, the unequivocal progression of existing non-target lesions (non-TL), or the appearance of 1 or more new lesions. TLs were selected on the basis of their size (those with the longest diameter) and their suitability for accurate repeated measurements by imaging techniques or clinically. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, were identified as TLs. All other lesions (or sites of disease) were identified as non-TLs.|Baseline to the end of the study (up to 3 years)|All 41 patients treated with erlotinib and pertuzumab. Patients who had not progressed or died at the time of analysis for PFS were censored at the date of their last tumor assessment.||Months||95% Confidence Interval|Median
788121|NCT00855894|Primary|Percentage of Patients With a 2-deoxy-2-[18F]Fluoro-D-glucose-positron Emission Tomography (FDG-PET) Response at Day 56 in All Patients and in Epidermal Growth Factor Receptor (EGFR) Mutant and Wild-type Subgroups|The assessment of FDG-PET response was performed by a central reading site. PET response was based on the maximum standard uptake value (SUVmax) of up to 5 regions of interest (ROI). The tumor ROIs were identified for each patient on pretreatment FDG-PET scans and corresponded to a subset of the target lesions identified for Response Evaluation Criteria for Solid Tumors (RECIST) analysis. Specifically, the SUVmax of each ROI on the on-treatment scans was compared with the SUVmax on the corresponding pretreatment scan and the percent change was calculated. When there was more than 1 ROI, the overall percent change in SUVmax was the arithmetic mean of the percent changes in SUVmax for each of the ROIs (mSUVmax). An PET response is defined as a decrease of ≥ 20% in mSUVmax. EGFR mutation status was assessed in tumor tissue samples taken from each patient.|Baseline to Day 56|All 41 patients treated with pertuzumab and erlotinib were evaluable for analysis. Patients with a missing Day 56 assessment were deemed non-responders. Tumor tissue samples were only available for 32 patients for EGFR mutation status analysis.||Percentage of patients||95% Confidence Interval|Number
788122|NCT00855920|Secondary|Change From Baseline in Patient's Assessment of Pain Using a 5-Point Likert Scale (PAP-LS) in Index Joint at 24 Hours|Participants were asked to complete a daily diary entry and assessed their pain in the past 24 hours using 5-point Likert Scale of 0 (None) to 4 (extreme pain), where; 0= none, 1= mild pain, 2= moderate pain, 3= severe pain, or 4= extreme pain.|Baseline (Day 1) to 24 hours|Full analysis set (FAS) that included all randomized participants who received any study drug and had at least 1 post-baseline assessment. Here, number of participants analyzed=participants with available data for this endpoint.||units on a scale||Standard Deviation|Mean
788123|NCT00855920|Secondary|Change From Baseline in Patient's Assessment of Pain Using a 5-Point Likert Scale (PAP-LS) in Index Joint at 48 Hours|Participants were asked to complete a daily diary entry and assessed their pain in the past 24 hours using 5-point Likert Scale of 0 (None) to 4 (extreme pain), where; 0= none, 1= mild pain, 2= moderate pain, 3= severe pain, or 4= extreme pain.|Baseline (Day 1) to 48 hours|Full analysis set (FAS) that included all randomized participants who received any study drug and had at least 1 post-baseline assessment. Here, number of participants analyzed=participants with available data for this endpoint.||units on a scale||Standard Deviation|Mean
788124|NCT00855920|Secondary|Change From Baseline in Patient's Assessment of Pain Using a 5-Point Likert Scale (PAP-LS) in Index Joint at 72 Hours|Participants were asked to complete a daily diary entry and assessed their pain in the past 24 hours using 5-point Likert Scale of 0 (None) to 4 (extreme pain), where; 0= none, 1= mild pain, 2= moderate pain, 3= severe pain, or 4= extreme pain.|Baseline (Day 1) to 72 hours|Full analysis set (FAS) that included all randomized participants who received any study drug and had at least 1 post-baseline assessment. Here, number of participants analyzed=participants with available data for this endpoint.||units on a scale||Standard Deviation|Mean
788125|NCT00855920|Primary|Change From Baseline in Patient's Assessment of Pain Using a 5-Point Likert Scale (PAP-LS) in Index Joint to Averaged PAP-LS at 24, 48 and 72 Hours|Participants were asked to complete a daily diary entry and assessed their pain in the past 24 hours using 5-point Likert Scale of 0 (None) to 4 (extreme pain), where; 0= none, 1= mild pain, 2= moderate pain, 3= severe pain, or 4= extreme pain. Change in PAP-LS in the index joint from baseline (Day 1) to the averaged PAP-LS values at 24, 48 and 72 hours was reported in this outcome measure (averaged PAP value= [PAP at 24 hours + PAP at 48 hours + PAP at 72 hours]/3).|Pre-dose on Day 1 (Baseline); post-dose at 4, 8, 12, 24, 48, 72 hours and then daily up to Day 13 or until gout flare ends|Full analysis set (FAS) that included of all randomized participants who received any study drug and had at least 1 post-baseline assessment.||units on a scale||Standard Deviation|Mean
788126|NCT00855933|Primary|Whole Mouth Lobene Modified Gingival Index Between the Brushing Only Group and the Brushing + Flossing Group [30 Days] Units on the MGI Scale|"A whole-mouth average Lobene Modified Gingival Index was calculated by summing the scores and dividing by the number of sites graded (excludes missing teeth & sites not graded). Whole mouth average can range from 0 (normal) to 4 (severe inflammation).
For each tooth, six gingival areas (distobuccal, buccal, mesiobuccal, mesiolingual, lingual, and distolingual) were scored using the following scale: 0=Normal (Absence of inflammation, 1=Mild inflammation (slight change in color, little change in texture) of any portion of but not the entire marginal or papillary gingival unit, 2=Mild inflammation criteria as above but involving the entire marginal or papillary gingival unit, 3=Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the marginal or papillary gingival unit, 4=Severe inflammation (marked redness, edema and/or hypertrophy, spontaneous bleeding or ulceration) of the marginal or papillary gingival unit."|4 weeks|||units on a scale||Standard Error|Mean
788127|NCT00855959|Secondary|Number of Participants With Adverse Events (AEs)|Number of participants with AEs reported during the period on Pulmicort Respules|6 weeks|||Participants|||Number
788128|NCT00855959|Secondary|Forced Vital Capacity (FVC)|Change in Forced Vital Capacity (FVC) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)|6 weeks|||L||Standard Deviation|Mean
788129|NCT00855959|Secondary|Forced Expiratory Volume in 1 Second (FEV 1.0)|Change in Forced Expiratory Volume in 1 second (FEV 1.0) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)|6 weeks|||L||Standard Deviation|Mean
788133|NCT00855959|Secondary|Use of Rescue Medication (Daytime)|Change in Use of rescue medication (Daytime) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)|6 weeks|||puffs||Standard Deviation|Mean
788134|NCT00855959|Secondary|Asthma Symptom Score (Total); Score of 0-3 (0 = no Asthma Symptoms - 3 = Severe Symptoms)|Change in Asthma symptom score (Total) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)|6 weeks|||Scores on a scale||Standard Deviation|Mean
788135|NCT00855959|Secondary|Asthma Symptom Score (Night-time); Score of 0-3 (0 = no Asthma Symptoms - 3 = Severe Symptoms)|Change in Asthma symptom score (Night-time) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)|6 weeks|||Scores on a scale||Standard Deviation|Mean
788136|NCT00855959|Secondary|Asthma Symptom Score (Daytime); Score of 0-3 (0 = no Asthma Symptoms - 3 = Severe Symptoms)|Change in Asthma symptom score (Daytime) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)|6 weeks|||Scores on a scale||Standard Deviation|Mean
788137|NCT00855959|Secondary|Evening Peak Expiratory Flow (ePEF)|Change in evening peak expiratory flow (ePEF) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)|6 weeks|||L/min||Standard Deviation|Mean
788138|NCT00855959|Primary|Morning Peak Expiratory Flow (mPEF)|Change in morning peak expiratory flow (mPEF) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)|6 weeks|||L/min||Standard Deviation|Mean
788139|NCT00856024|Secondary|Percent of Participants Who Achieved Early Virologic Response (EVR)|EVR was defined as HCV RNA negative after 12 weeks of treatment.|Week 12|Number of participants with data||Percent of participants||95% Confidence Interval|Number
788140|NCT00856024|Secondary|Percent of Participants Who Achieved Rapid Virologic Response (RVR)|RVR was defined as HCV RNA negative after 4 weeks of treatment.|Week 4|Number of participants with data||Percent of participants||95% Confidence Interval|Number
788141|NCT00856024|Primary|Percent of Participants Who Were Compliant to Treatment in the First 12 Weeks|The participant was considered compliant if he/she had administered 80% of the doses of pegylated interferon alpha 2b and 80% of the doses of ribavirin that were prescribed by the physician in the first 12 weeks of treatment.|First 12 weeks of treatment|All enrolled participants||Percent of participants||95% Confidence Interval|Number
788142|NCT00856050|Primary|Progression Free Survival Rate at 12 Weeks|Data below are reported as progression free rate (%).|12 weeks|27 patients were enrolled, and 26 patients received at least one dose of study medication and were included in the analysis.||percentage of participants||90% Confidence Interval|Number
788143|NCT00856180|Secondary|Overall Survival (OS)|OS estimated using Kaplan-Meier methods is defined as the time from study entry to death or date last known alive.|Participants were followed long-term for survival every 3 months from the end of treatment until death or lost to follow-up. Median follow-up was 23 months in this study cohort.|The analysis dataset is comprised of all treated participants.||months||95% Confidence Interval|Median
788144|NCT00856180|Secondary|Progression-Free Survival (PFS)|PFS estimated using Kaplan-Meier methods is defined as the duration of time from the start of bevacizumab alone to documented disease progression (PD) requiring removal from the study or death. If participant ultimately received both bevacizumab and cyclophosphamide then it was the time until PD on both agents. Per RECIST 1.0 for target lesions, PD is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or appearance of new lesions. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Serologic PD is rise in CA-125 or previously normal CA-125 that rises to >/=2xULN documented, both requiring 2nd confirmation. Participants who were event-free were censored at the date of their last disease evaluation.|Radiologic disease assessments occurred every 2 cycles/6 weeks on treatment and every 3 months in follow-up until PD, death or lost to follow-up. Median treatment duration was 7.5 months (range 0.7-20.7) and survival follow-up 23 months..|The analysis dataset is comprised of all treated participants.||months||95% Confidence Interval|Median
788145|NCT00856180|Secondary|Clinical Benefit Response Rate|Clinical benefit response rate is defined as the proportion of participants who achieve confirmed stable disease (SD) or better on treatment based on RECIST 1.0 criteria. Per RECIST 1.0 for target lesions, complete response (CR) is disappearance of all target lesions and partial response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. Progressive disease (PD) is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started. SD is neither PR nor PD. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|Radiologic disease assessments occurred every 2 cycles/6 weeks on treatment. Median treatment duration for this study cohort was 7.5 months (range 0.7-20.7).|The analysis dataset is comprised of all treated participants.||proportion of participants||90% Confidence Interval|Number
788146|NCT00856180|Primary|Grade 3-5 Gastrointestinal Perforation|All grade 3-5 gastrointestinal perforation events based on CTCAEv3 as reported on case report forms.|Assessed each cycle/3 weeks throughout treatment from time of first dose and up to day 30 post-treatment. Median treatment duration for this study cohort was 7.5 months (range 0.7-20.7).|The analysis dataset is comprised of all treated participants.||proportion of participants||90% Confidence Interval|Number
788168|NCT00856297|Secondary|Number of Subjects Who Reported Medically Attended Adverse Events, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine|Safety was assessed in terms of number of subjects with medically attended AEs within 28 days after vaccination with one dose of either MenACWY-CRM conjugate or licensed comparator vaccine.|28 days postvaccination|Analysis was done on safety population - subjects who received vaccination with MenACWY-CRM conjugate vaccine, provided post-baseline safety data and provide safety follow-up information for any period during the 28 day follow-up.||subjects|||Number
788307|NCT00856843|Secondary|Mean Change in Serum Chemistry (mEq/L)|Mean changes from Baseline to Post-preparation for the following analytes will be compared between treatment groups: bicarbonate, chloride, magnesium, potassium, sodium. Baseline lab samples were allowed to be drawn within 15 days of the post-preparation (Visit 2) lab draw.|up to 15 days|||mEq/L||Standard Deviation|Mean
788147|NCT00856180|Primary|Therapy Completion Rate|The therapy completion rate is defined as the proportion of participants who completed at least 3 months/4 cycles of therapy. Participants were treated until disease progression on the combination regimen or unacceptable toxicity. Clinical response was evaluated based on RECIST 1.0 criteria for measurable disease (MD) participants and Gynecologic Cancer Intergroup (GCIG) CA-125 (Rustin) criteria for non-MD participants. Per RECIST 1.0 for target lesions, PD is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or appearance of new lesions. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Serologic PD is rise in CA-125 or previously normal CA125 that rises to >/=2xULN documented, both requiring 2nd confirmation.|Serologic and radiologic disease assessments occurred every 2 cycles/6 weeks on treatment. Median treatment duration for this study cohort was 7.5 months (range 0.7-20.7).|The analysis dataset is comprised of all treated participants.||proportion of participants||80% Confidence Interval|Number
788148|NCT00856193|Secondary|Number of Participants Who Experienced Adverse Events (AEs), Serious Adverse Events (SAEs)|According to FDA 21CFR 314.80, a serious adverse event (SAE) is described as any adverse event that leads to death, is life threatening , causes or prolongs hospitalization, results in a congenital anomaly, or any other important medical event not described above. See Adverse Events module for details.|Day 14|Safety Population||Participants|||Number
788149|NCT00856193|Secondary|Forced Expiratory Volume in One Second (FEV1) AUC 12-24 Hours on Day 14|Forced Expiratory Volume in one second (FEV1) was calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change is FEV1 from pre-dose (day 1) to the readings taken 12-24 hours post dose on day 14. The variable was analyzed with an analysis-of-covariance model which included baseline FEV1 value as a covariate.|From Day 1 to 12 hours-24 hours after drug administration on Day 14|Efficacy analysis set||Liters||Standard Error|Least Squares Mean
788150|NCT00856193|Secondary|Forced Expiratory Volume in One Second (FEV1) AUC 0-12 Hours on Day 14|Forced Expiratory Volume in one second (FEV1) was calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change is FEV1 from pre-dose (day 1) to the readings taken 0-12 hours post dose on day 14. The variable was analyzed with an analysis-of-covariance model which included baseline FEV1 value as a covariate.|From day 1 to 0 -12 hours after drug administration on Day 14|Efficacy analysis set||Liters||Standard Error|Least Squares Mean
788151|NCT00856193|Primary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve (AUC) 0-24 Hours on Day 14|Forced Expiratory Volume in one second (FEV1) was calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change is FEV1 from predose (day 1) to the readings taken 0-24 hours post dose on day 14. The variable was analyzed with an analysis-of-covariance model which included baseline FEV1 value as a covariate.|From Day 1 to 0-24 hours after drug administration on Day 14|Efficacy analysis set||Liters||Standard Error|Least Squares Mean
788152|NCT00856206|Secondary|Number of Gout Flare Days Per Participant From Day 1 to Day 112 (Week 16)|A gout flare was defined as participant reported acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Number of gout flares per participant was reported for this outcome measure. Flare days were counted up to Week 16, regardless of whether or not the flares occurred during the treatment period.|Day 1 to Day 112 (Week 16)|FAS that included all randomized participants who received any study medication, and was based on the treatment allocated by the IVRS at randomization (as randomized). Here, number of participants analyzed=participants with available data for this endpoint.||Gout flare Days||Standard Deviation|Mean
788153|NCT00856206|Secondary|Percentage of Participants With at Least Two Flares From Day 1 to Day 112 (Week 16)|A gout flare was defined as participant reported acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Percentage of participants with at least two gout flare was reported for this outcome measure. For drop-outs, only flares occurred before Day 112 were counted, regardless whether the flares occurred during the treatment period or not.|Day 1 to Day 112 (Week 16)|FAS that included all randomized participants who received any study medication, and was based on the treatment allocated by the IVRS at randomization (as randomized).||percentage of participants|||Number
788154|NCT00856206|Secondary|Percentage of Participants With at Least One Flare From Day 1 to Day 112 (Week 16)|A gout flare was defined as participant reported acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Percentage of participants with at least one gout flare was reported for this outcome measure. For drop-outs, only flares occurred before Day 112 were counted, regardless whether the flares occurred during the treatment period or not.|Day 1 to Day 112 (Week 16)|FAS that included all randomized participants who received any study medication, and was based on the treatment allocated by the IVRS at randomization (as randomized).||percentage of participants|||Number
788155|NCT00856206|Secondary|Number of Gout Flares Per Participant Assessed From Day 1 to Day 112 (Week 16)|A gout flare was defined as participant reported acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Number of gout flares per participant was reported for this outcome measure. For drop-outs, only flares occurred before Day 112 were counted, regardless whether the flares occurred during the treatment period or not.|Day 1 to Day 112 (Week 16)|Full analysis set (FAS) that included all randomized participants who received any study medication, and was based on the treatment allocated by the Interactive voice response system (IVRS) at randomization (as randomized). Here, number of participants analyzed=participants with available data for this endpoint.||Gout flares||Standard Deviation|Mean
788156|NCT00856206|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)|Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on-treatment period (time from the administration of first dose of study drug up to 35 days after the last dose of study drug). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.|Baseline up to Week 20|Safety analysis set that included all participants who received any study drug and safety analyses were based on the treatment received.||percentage of participants|||Number
788157|NCT00856232|Primary|Time to Relief (Min)|Time to relief is a measure of time reported by a stopwatch the patients were provided in the beginning of the study, which showed elapsed time in minutes for patients to perceive that they no longer had a headache.|study duration|||Minutes||Standard Deviation|Mean
788158|NCT00856232|Secondary|Length of Stay in the Emergency Department(Min)|Length of stay was reported as time elapsed in minutes from subject's arrival as a patient to the Emergency Department to patient's discharge from the Emergency Department.|Study duration|||Minutes||Standard Deviation|Mean
788159|NCT00856245|Secondary|Progression Free Survival (PFS) and Overall Survival (OS)|Response will be determined by Response Evaluation Criteria in Solid Tumors (RECIST v1.0) criteria where applicable and/or biopsy proven relapse/progression of disease.|up to 60 months|Of the 14 patients that had harvestable cells, 3 chose to delay transplant. The remaining 11 patients underwent Autologous stem cell transplantation (Auto-SCT).||months||Full Range|Median
788160|NCT00856245|Primary|Rate of PCR Negativity|Number of participants that are tumor free by PCR (Polymerase Chain Reaction) analysis post-transplant.|up to 7 days|21 patients were initially enrolled; 2 were withdrawn after signing informed consent per physician decision. Of the remaining 19: 5 did not have harvestable stem cells; 14 completed stem cell collection and PCR evaluation.||Participants|||Count of Participants
788182|NCT00856323|Primary|Self-reported Methamphetamine Use in Previous 30 Days.|Mean number of days (of the past 30) of methamphetamine use.|3-months after baseline|53 enrolled and 2 were withdrawn.||days||Standard Deviation|Mean
788492|NCT00857818|Secondary|Mean Changes in Weight From Baseline||Baseline to Weeks 4, 8, and 16|Due to low enrollment, the study was terminated early. This endpoint was not analyzed because there were insufficient data to draw meaningful conclusions.|||||
788169|NCT00856297|Secondary|Number of Subjects With New Medical Diagnoses of Chronic Diseases, After One Dose of Either MenACWY-CRM Conjugate Vaccine or Licensed Comparator|Safety was assessed in terms of number of subjects with new diagnoses of chronic diseases, among subjects who had previously received one dose of either MenACWY-CRM conjugate vaccine or licensed comparator vaccine.|Day 1 to 5 years|Analysis was done on safety follow-up population - subjects enrolled at 5 years were included in the safety follow-up for 24 hours after blood draw and for analysis of medical history to identify new onset of chronic diseases.||subjects|||Number
788170|NCT00856297|Secondary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events|Safety was assessed as the number of subjects who had previously been vaccinated in the parent study with MenACWY-CRM or licensed comparator who reported solicited local and systemic adverse events within 7 days after the administration of a booster dose of MenACWY-CRM conjugate vaccine at 3 year time point.|Day 1 to Day 7|Analysis was done on the solicited safety dataset, i.e. the subjects in the exposed population who provided postvaccination safety data.||subjects|||Number
788171|NCT00856297|Secondary|Persistence of hSBA Geometric Mean Titers (GMTs) in Subjects After One Dose of MenACWY-CRM Conjugate Vaccine|Persistence of immune response at two years following administration of one dose of MenACWY-CRM conjugate vaccine in subjects who previously received one dose of either MenACWY-CRM conjugate or licensed comparator vaccine, as measured by hSBA GMTs against N meningitidis serogroups A, C, W and Y.|2 years postvaccination|Analysis was done on PP post booster persistence population - subjects who provided one evaluable serum sample at baseline at any visit (3 years and 5 years) and had no major protocol deviations.||titers||95% Confidence Interval|Geometric Mean
788172|NCT00856297|Secondary|Percentages of Subjects With hSBA Titers≥ 1:4 and ≥ 1:8 in Subjects After One Dose of MenACWY-CRM Conjugate Vaccine|Persistence of immune response at two years following administration of one dose of MenACWY-CRM conjugate vaccine in subjects who previously received one dose of either MenACWY-CRM conjugate or licensed comparator vaccine, as measured by hSBA titers≥ 1:4 and ≥ 1:8 against N meningitidis serogroups A, C, W and Y.|2 years postvaccination|Analysis was done on PP post booster persistence population - subjects who provided one evaluable serum sample at baseline at any visit (3 years and 5 years) and had no major protocol deviations.||percentages of subjects||95% Confidence Interval|Number
788173|NCT00856297|Secondary|Percentages of Subjects With hSBA Titers≥ 1:4 and ≥ 1:8 After a Booster Dose of MenACWY-CRM Conjugate Vaccine|Immune response at one month after one dose of MenACWY-CRM conjugate vaccine in subjects who had previously received one dose of MenACWY-CRM conjugate vaccine or licensed comparator vaccine, as measured by percentages of subjects with hSBA Titers≥ 1:4 and ≥ 1:8 against N meningitidis serogroups A, C, W and Y.|1 month post booster vaccination|Analysis was done on PP post booster persistence population - subjects who provided one evaluable serum sample at baseline at any visit (3 years and 5 years) and had no major protocol deviations.||percentages of subjects||95% Confidence Interval|Number
788174|NCT00856297|Secondary|hSBA Geometric Mean Titers (GMT) in Subjects With No Previous Meningococcal Vaccination|Immune response of age-matched subjects with no previous meningococcal vaccination, as measured by hSBA geometric mean titers (GMTs) against N meningitidis serogroups A, C, W and Y.|day 1|Analysis was done on PP persistence population (Naive subjects) - subjects who provided one evaluable serum sample at baseline and had no major protocol deviations.||titers||95% Confidence Interval|Geometric Mean
788175|NCT00856297|Secondary|Percentages of Subjects With No Previous Meningococcal Vaccination With hSBA Titers≥ 1:4 and ≥ 1:8|Immune response of age-matched naive subjects with no previous meningococcal vaccination, as measured by the percentages of subjects with hSBA titers≥ 1:4, and ≥ 1:8 against N meningitidis serogroups A, C, W and Y.|day 1|Analysis was done on PP persistence population - subjects who provided one evaluable serum sample at baseline and had no major protocol deviations.||percentages of subjects||95% Confidence Interval|Number
788176|NCT00856297|Secondary|hSBA Geometric Mean Titers (GMTs), After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine|Immune response of one dose of MenACWY-CRM conjugate vaccine compared to that of one dose of licensed comparator vaccine at 21 months, 3 years and 5 years after vaccination, as measured by the hSBA Geometric Mean Titers (GMTs) against N meningitidis serogroups A, C, W and Y.|21 months, 3 years and 5 years postvaccination|Analysis was done on PP persistence population - subjects who provided one evaluable serum sample at baseline at any visit (21 months, 3 years and 5 years) and had no major protocol deviations.||titers||95% Confidence Interval|Geometric Mean
788177|NCT00856297|Secondary|Percentages of Subjects With hSBA Titers≥ 1:4, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine|Immune response of one dose of MenACWY-CRM conjugate vaccine compared to that of one dose of licensed comparator vaccine at 21 months, 3 years and 5 years after vaccination, as measured by the percentages of subjects with hSBA titers≥ 1:4 against N meningitidis serogroups A, C, W and Y.|21 months, 3 years and 5 years postvaccination|Analysis was done on PP persistence population - subjects who provided one evaluable serum sample at baseline at any visit (21 months, 3 years and 5 years) and had no major protocol deviations.||percentages of subjects||95% Confidence Interval|Number
788178|NCT00856297|Primary|Percentages of Subjects With Human Complement Serum Bactericidal Activity (hSBA) Titers≥ 1:8, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine|Immune response of one dose of MenACWY-CRM conjugate vaccine compared to that of one dose of licensed comparator vaccine at 21 months, 3 years and 5 years after vaccination, as measured by the percentages of subjects with human complement serum bactericidal activity (hSBA) titers≥ 1:8 directed against N meningitidis serogroups A, C, W and Y.|21 months, 3 years and 5 years postvaccination|Analysis was done on PP persistence population - subjects who provided one evaluable serum sample at baseline at any visit (21 months, 3 years and 5 years) and had no major protocol deviations.||percentages of subjects||95% Confidence Interval|Number
788179|NCT00856323|Secondary|Post-Exposure Prophylaxis Medication Adherence|Median medication adherence rate, defined as the proportion of pills taken relative to the number of pills prescribed (i.e., # of pills taken / # of pills prescribed).|28-days|35 participants initiated PEP||proportional medication adherence||Inter-Quartile Range|Median
788180|NCT00856323|Secondary|HIV-related Sexual Risk Behaviors in Previous 30 Days.|Self-reported episodes of Unprotected Anal Intercourse in the previous 30 days.|3-months after baseline|53 enrolled and 2 were withdrawn.||episodes||Standard Deviation|Mean
788181|NCT00856323|Secondary|Description of Incident STI Infections.|Proportional 3-month incidence of syphilis, rectal gonorrhea, pharyngeal gonorrhea, and rectal Chlamydia.|Baseline and 3-months|53 enrolled and 2 were withdrawn.||Proportion of Participants||Full Range|Mean
788183|NCT00856349|Secondary|Relationship of Subject Characteristics and Geographical Regions With Shock Reduction Programming Utilization|Characterization of shock reduction programming utilization by subject characteristics and geographical regions|Overall study (20 months on average)|Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints, with final programming data available post-TPR distribution.||percentage of participants|||Number
788184|NCT00856349|Secondary|Barriers to Utilization of Shock Reduction Programming|Characterization of barriers to physician utilization of shock reduction programming|24 months follow-up visit|Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.||% of subjects not programmed to target|Participants||Number
788185|NCT00856349|Secondary|Actions Taken Following a Shock|Characterization of actions taken by the subject immediately following a device shock|Overall study (20 months on average)|Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.||percentage of subjects with shocks|Participants||Number
788186|NCT00856349|Secondary|Reasons for Inappropriate Shocks|Reasons for inappropriate shocks observed during the study|Overall study (20 months on average)|Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.||percentage of inappropriate shocks|Participants||Number
788187|NCT00856349|Secondary|Lead Integrity Alert (LIA) Performance|Causes for LIA triggers reported during the study|Overall study (20 months on average)|Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.||percentage of subjects with LIA triggers|Participants||Number
788188|NCT00856349|Primary|Change in Shock Reduction Programming Adoption|"Change in percentage of subjects programmed to evidence-based target from baseline (pre-TPR distribution) to last follow-up (post-TPR distribution).
Shock-reduction programming parameters:
LIA (Lead Integrity Alert): Uploadable algorithm with the ability to increase the time between a lead fracture and potential delivery of an unnecessary shock.
SVT (Supraventricular Tachycardia) Limit: The maximum cycle length that Wavelet and PR logic will be applied to arrhythmias.
VF NID PP: Number of intervals to detect (NID) an arrhythmia in the VF zone for primary prevention (PP) patients.
VF NID SP: Number of intervals to detect (NID) an arrhythmia in the VF zone for secondary prevention (SP) patients.
Wavelet: Discriminator to help determine if arrhythmia is ventricular or supraventricular in single chamber ICDs.
PR Logic: Discriminator to help determine if arrhythmia is ventricular or supraventricular in dual chamber ICDs and CRT-Ds."|Overall study (20 months on average)|Subjects with paired baseline and follow-up programming data||percentage of participants|||Number
788189|NCT00856388|Secondary|3 yr Overall Survival|3 yr Overall Survival estimated using the Kaplan-Meier method.|Up to 4.5 years|All treated and eligible patients||percentage of participants||95% Confidence Interval|Number
788190|NCT00856388|Secondary|1 yr Extenstive Chronic GVHD|"1 yr Extensive Chronic GVHD
Summarized using standard descriptive statistics along with corresponding 95% confidence intervals."|Up to 4.5 years|All treated and eligible who survived to day 100 and were eligible to get chronic GVHD||percentage of participants||95% Confidence Interval|Number
788191|NCT00856388|Secondary|Acute GVHD Grade III-IV|"Acute GVHD grade III-IV
Summarized using standard descriptive statistics along with corresponding 95% confidence intervals."|Up to day 100|All treated and eligible patients||percentage of participants||95% Confidence Interval|Number
788192|NCT00856388|Secondary|Rate of Complete Donor Chimerism - Blood|"Rate of Complete Donor Chimerism - Blood
Summarized using standard descriptive statistics."|Day 100|All treated and eligible patients, who were able to complete testing||percentage of participants|||Number
788193|NCT00856388|Secondary|Rate of Complete Donor Chimerism - Blood|"Rate of Complete Donor Chimerism - Blood
Summarized using standard descriptive statistics."|Day 30|All treated and eligible patients, who were able to complete testing||percentage of participants|||Number
788194|NCT00856388|Secondary|Median Time to Platelet Engraftment|"Median Time to Platelet Engraftment
Summarized using standard descriptive statistics along with corresponding 95% confidence intervals."|Day 100|All treated and eligible patients||Days||Full Range|Median
788195|NCT00856388|Secondary|Median Time to ANC Engraftment|"Median Time to ANC Engraftment
Summarized using standard descriptive statistics along with corresponding 95% confidence intervals."|Days 30|All treated and eligible patients||Days||Full Range|Median
788196|NCT00856388|Primary|Day 100 TRM|Day 100 Treatment Related Mortality An exact 95% confidence interval will be provided.|First 100 days|All treated and eligible patients||percentage of participants||95% Confidence Interval|Number
788197|NCT00856414|Secondary|Percentage of Patients Reporting Self-Perception of Age (SPA)|"Percentage of patients reporting their SPA. SPA is measured by a questionnaire. Patients were asked to compare their facial appearance to their current age. Response options were Looking younger, Looking current age, and Looking older. Results for each response are presented for Baseline and Day 14."|Baseline, Day 14|Intent to Treat defined as all patients who started the study||Percentage of patients|||Number
788198|NCT00856414|Secondary|Change From Baseline in Patient Satisfaction as Measured by Facial Line Outcome (FLO) Questionnaire Score|Change from baseline in patient satisfaction as measured by FLO questionnaire comprised of 11 items that assess subject's perceptions about specific aspects of their facial lines for the previous 7 days. Each question is scored on a 11-point scale (0=not at all, 5=somewhat, 10=very much) and the sums are converted to the total FLO score. The minimum total FLO score is 0 (worst) and the maximum total FLO score is 100 (best). The total FLO score was calculated at baseline and Day 14. A positive number change from baseline indicates an improvement.|Baseline, Day 14|Intent to Treat defined as all patients who started the study||Scores on a Scale||Standard Deviation|Mean
788199|NCT00856414|Secondary|Average Subject Assessment Score in Improvement of Appearance of Frown Lines|Average subject assessment score in improvement of appearance of frown lines (lines between the eyebrows) as measured by a 7-point scale (1=very much improved and 7=very much worse)on a daily basis. The average scores over the 1st diary week (1-7 days) and the 2nd diary week (8-14 days) are presented.|14 Days|Intent to Treat defined as all patients who started the study||Scores on a Scale||Standard Deviation|Mean
788200|NCT00856414|Primary|The First Visit Onset of Efficacy as Measured by Subject Assessment|"The first visit onset of efficacy as measured by subject assessment. Onset is determined by a yes/no answer to the question Since being injected, have you noticed any effect on the appearance of your frown lines (lines between the eyebrows)? at days 2, 3, 4, 7, and 14."|14 Days|Intent to Treat defined as all patients who started the study||Number of Days||Standard Deviation|Mean
788201|NCT00856414|Primary|The First Visit Onset of Efficacy as Measured by Physician Assessment|"The first visit onset of efficacy as measured by physician assessment. Onset is determined by a yes/no answer to the question Since injecting the patient, have you noticed any effect on the appearance of the patient's frown lines (lines between the eyebrows)? at days 2, 3, 4, 7, and 14."|14 Days|Intent to Treat defined as all patients who started the study||Number of Days||Standard Deviation|Mean
788202|NCT00856492|Secondary|Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Up to 28 weeks|All participants receiving at least some protocol treatment||Participants|||Number
788203|NCT00856492|Secondary|Event-free Survival|Time from registration to first instance of any of the following events: progression prior to surgery, recurrence post-surgery or death from any cause.|Disease assessed every 4 weeks while on treatment then every 6 months for one year then annually for four years from registration or until recurrence|Pre-specified analysis of Arm 1 vs. Arm 2/3 to compare effect of bevacizumab||participants|||Number
788204|NCT00856492|Secondary|Overall Survival|Time from registration to death due to any cause|Disease assessed every 4 weeks while on treatment then every 6 months for one year then annually for four years from registration.|Pre-specified analysis of Arm 1 vs. Arm 2/3 to compare effect of bevacizumab||deaths|||Number
788205|NCT00856492|Primary|Number of Patients With Pathological Complete Response Rate|Pathologic complete response (pCR), commonly defined as the absence of residual invasive cancer in both the breast and axillary lymph nodes, has emerged as a surrogate endpoint for disease-free and overall survival, as the achievement of a pCR is associated with a favorable long-term prognosis in all breast cancer subtypes.|pre-study pathology vs. post-chemo surgery pathology (approx. 39-42 weeks post-randomization)|Pre-specified analysis of Arm 1 vs. Arm 2/3 to compare effect of bevacizumab||Participants|||Count of Participants
788206|NCT00856518|Primary|Swallow-related Quality of Life (SWAL-QOL)|The SWAL-QOL is a validated and standardized tool that measures burden; symptom status including pharyngeal, oral, and saliva; fear; and mental health subdomains. Responses are determined according to an ordinal scale where 1 equals a severe problem and 5 equals no problem. The SWAL-QOL provides an overall score as well as subscale scores. Subjects rate quality of life as follows (expressed as percentage of the possible perfect score): little to no impact (81% - 100%), mild impact (61% - 80%), moderate impact (41% - 60%), severe impact (21% - 40%), and profound impact (0% - 20%).|at baseline and after 5-week of EMST exercise|Out of the total 42 recruited study participants, ten either did not show up for the SWAL-QOL test or only partially answered the questionnaire. Thus, 32 remaining participants (n = 19 for EMST, and n = 13 for Sham) were reported.||percentage of possible perfect score||Standard Deviation|Mean
788207|NCT00856518|Primary|Penetration-Aspiration Scale Score|"The Penetration-Aspiration Scale (PAS) was used to measure swallow safety. PAS is an 8 point ordinal scale for quantification of penetration and aspiration. PAS measures the depth to which material enters the airway and if the material is expelled following penetration or aspiration. Categorical groupings of PAS scores include normal to mild (1-2), moderate (3-5) and severe (6-8, indicating that material has passed into the lower airway). These PAS scores may be useful in denoting clinically significant changes (e.g. moderate to mild) resulting from treatment or disease progression. The following table reports the percentage of participants (out of the respective total group participants in EMST and Sham) with changed PAS score of 1 point or more (improving or worsening) and without PAS score changes from pre- to post treatment. The data represent an exploratory quantification without statistical analysis."|at baseline and again after 5-week EMST exercise|Out of the 42 recruited patients, 8 failed to complete the PAS test either at baseline or post training testing. Therefore, 34 subjects were reported for the PAS test (n = 20 for EMST, n = 14 for sham).||percentage of group participants|||Number
788208|NCT00856518|Primary|Maximum Expiratory Pressure (MEP)|Expiratory pressure generating capacity assessed via handheld manometer.|at baseline and again after 5-week EMST exercise|Out of the 42 recruited patients, 6 withdrew following the baseline MEP testing, citing travel or loss of interest as the reason. Therefore, 36 subjects were reported for the MEP test (n = 20 for EMST, n = 16 for sham).||cm H2O||Standard Deviation|Mean
788209|NCT00856544|Secondary|Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 12|Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance.|Month 12|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
788210|NCT00856544|Secondary|Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 6|Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance.|Baseline, Month 3, 6|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
788211|NCT00856544|Secondary|Number of Hours Per Day as Assessed RA-HCRU at Month 12|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported.|Month 12|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.'n' signifies those participants who were evaluable for given parameters for each group respectively.||hours per day||Standard Deviation|Mean
788212|NCT00856544|Secondary|Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported.|Baseline, Month 3, 6|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.'n' signifies those participants who were evaluable for each parameter at given time points for each group respectively.||hours per day||Standard Deviation|Mean
788213|NCT00856544|Secondary|Number of Days as Assessed Using RA-HCRU at Month 12|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains.Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.|Month 12|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for given parameters for each group respectively.||days||Standard Deviation|Mean
788214|NCT00856544|Secondary|Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains.Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.|Baseline, Month 3, 6|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.'n' signifies those participants who were evaluable for each parameter at given time points for each group respectively.||days||Standard Deviation|Mean
788215|NCT00856544|Secondary|Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.|Month 12|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure for given parameters for each group respectively.||events||Standard Deviation|Mean
788216|NCT00856544|Secondary|Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.|Baseline, Month 3, 6|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.'n' signifies those participants who were evaluable for each parameter at given time points for each group respectively.||events||Standard Deviation|Mean
788217|NCT00856544|Secondary|Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12|Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost:visit to doctor,non-medical practitioner,nursing home,hospital,surgery,emergency room(ER) treatment,diagnostic tests, over-night stay,home healthcare services, aids/devices used. Indirect costs associated with functional disability:employment status,willingness to work,work disability due to RA,sick leave,part time work,ability to perform chores,chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale;higher score=higher medical cost.|Month 12|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for given parameters for each group respectively.||units on a scale||Standard Deviation|Mean
788218|NCT00856544|Secondary|Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6|Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost:visit to doctor, non-medical practitioner, nursing home, hospital, surgery, emergency room(ER) treatment, diagnostic tests, over-night stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability:employment status, willingness to work, work disability due to RA, sick leave,part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale;higher score=higher medical cost.|Baseline, Month 3, 6|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.'n' signifies those participants who were evaluable for each parameter at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
788219|NCT00856544|Secondary|Work Limitations Questionnaire (WLQ) Score at Month 12|WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: time management scale (5-items); physical demands scale (6-item); mental-interpersonal demands scale (9-items); output demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work loss index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0[no loss] to 100[complete loss of work]).|Month 12|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for given parameters for each group respectively.||units on a scale||Standard Deviation|Mean
788220|NCT00856544|Secondary|Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6|WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: time management scale (5-items); physical demands scale (6-item); mental-interpersonal demands Scale (9-items); output demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work loss index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0[no loss] to 100[complete loss of work]).|Baseline, Month 3, 6|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for each parameter at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
788287|NCT00848783|Secondary|Overall Survival Rate; Toxicity; Evaluation of Sites of Relapse of Failing Patients||every 4 months for the first 2 years, every 6 months for years 3 and 4, then every 12 months for up to 10 years||||||
788522|NCT00858013|Secondary|Fasting Glucose|fasting glucose (mg/dL) at 24 months|at 24 months|data of participants who finished 24 months of follow-up||mg/dL||Standard Deviation|Mean
788221|NCT00856544|Other Pre-specified|Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Assessment of Arthritis Pain|Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.|2 weeks|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||days|||Number
788222|NCT00856544|Other Pre-specified|Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Global Assessment of Arthritis|"Patient global assessment of arthritis: participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS where 0 = very well and 100 = very poorly."|2 weeks|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||days|||Number
788223|NCT00856544|Secondary|Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Month 12|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Month 12|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
788224|NCT00856544|Secondary|Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Baseline, Month 3 and 6|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Baseline, Month 3, 6|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
788225|NCT00856544|Secondary|Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 12|FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.|Month 12|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
788226|NCT00856544|Secondary|Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline, Month 1, 3, and 6|FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.|Baseline, Month 1, 3, 6|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
788227|NCT00856544|Secondary|Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12|MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported.|Month 12|FAS population included participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||participants|||Number
788228|NCT00856544|Secondary|Medical Outcome Study (MOS) Sleep Scale at Month 12|Participant-rated 12 item questionnaire to assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no). 9 item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score(RS) minus lowest possible score divided by possible RS range*100);total score range:0-100,higher score=more intensity of attribute.|Month 12|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
788229|NCT00856544|Secondary|Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6|MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported.|Baseline, Month 1, 3, 6|FAS population included participants who received at least 1 dose of study medication. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.||participants|||Number
788230|NCT00856544|Secondary|Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6|Participant-rated 12 item questionnaire to assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no). 9 item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score(RS) minus lowest possible score divided by possible RS range*100);total score range:0-100,higher score=more intensity of attribute.|Baseline, Month 1, 3, 6|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
788231|NCT00856544|Secondary|36-Item Short-Form Health Survey (SF-36) at Month 9 and 12|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.|Month 9, 12|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for the measure at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
788232|NCT00856544|Secondary|36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.|Baseline, Month 1, 3, 6|FAS population included participants who received at least 1 dose of study medication. Here, 'n' is signifying those participants who were evaluable for the measure at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
788233|NCT00856544|Secondary|Physician Global Assessment (PGA) of Arthritis at Month 9 and 12|Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.|Month 9, 12|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||mm||Standard Deviation|Mean
788234|NCT00856544|Secondary|Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6|Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.|Baseline, Week 2, Month 1, 2, 3, 4.5, 6|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.||mm||Standard Deviation|Mean
788235|NCT00856544|Secondary|Patient Global Assessment (PtGA) of Arthritis Pain at Month 9 and 12|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS where 0 = very well and 100 = very poorly."|Month 9, 12|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||mm||Standard Deviation|Mean
788236|NCT00856544|Secondary|Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS where 0 = very well and 100 = very poorly."|Baseline, Week 2, Month 1, 2, 3, 4.5, 6|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.||mm||Standard Deviation|Mean
788237|NCT00856544|Secondary|Patient Assessment of Arthritis Pain at Month 9 and 12|Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.|Month 9, 12|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||mm||Standard Deviation|Mean
788238|NCT00856544|Secondary|Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6|Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) visual analogue scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.|Baseline, Week 2, Month 1, 2, 3, 4.5, 6|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.||mm||Standard Deviation|Mean
788239|NCT00856544|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 9 and 12|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0=least difficulty and 3=extreme difficulty.|Month 9, Month 12|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
788288|NCT00848783|Primary|Number of Patients With One-year Recurrence-free Survival|This is defined as the patients who did not have recurrence of cancer at 1 year since the start of induction chemotherapy.|1 year|Based on intent-to-treat population.||participants|||Number
788289|NCT00856778|Secondary|Physician Questionnaire - Virtue® Was Easy to Position Over the Bulbous Urethra||At implant|||percentage of responses|||Number
788240|NCT00856544|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0=least difficulty and 3=extreme difficulty.|Baseline, Week 2, Month 1, 2, 3, 4.5, 6|FAS population. N (number of participants analyzed)=participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.||units on a scale||Standard Deviation|Mean
788241|NCT00856544|Secondary|Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR])|DAS28-3 (ESR) was calculated from the number of SJC and TJC using the 28 joints count and ESR (mm/hr). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (ESR) <=3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Baseline, Month 3, 6, 12|Since DAS28-3 (ESR) was determined to provide no new information over DAS28-4 (ESR) and DAS28-3 (CRP), there was a change in planned analysis and data was not analyzed for DAS28-3 (ESR).|||||
788242|NCT00856544|Secondary|Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])|DAS28-4 (CRP) was calculated from SJC and TJC using the 28 joints count, CRP [mg/L] and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 [CRP] <=3.2 implied low disease activity, DAS28-4 [CRP] >3.2 to 5.1 implied moderate to high disease activity and DAS28 <2.6 implied remission.|Baseline, Week 2, Month 1, 2, 3, 4.5, 6, 9, 12|Since DAS28-4 (CRP) was determined to provide no new information over DAS28-4 (ESR) and DAS28-3 (CRP), there was a change in planned analysis and data was not analyzed for DAS28-4 (CRP).|||||
788243|NCT00856544|Secondary|Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 12|DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Month 12|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
788244|NCT00856544|Secondary|Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 3 and 6|DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Baseline, Month 3, 6|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
788245|NCT00856544|Secondary|Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9 and 12|DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Month 9, 12|FAS population included participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
788246|NCT00856544|Secondary|Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6|DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Week 2, Month 1, 2, 3, 4.5, 6|FAS population included participants who received at least 1 dose of study medication. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
788247|NCT00856544|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 9 and 12|ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.|Month 9, 12|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal, advancement to active treatment before Month 6 were imputed using NRI method.||percentage of participants|||Number
788248|NCT00856544|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Week 2, Month 1, 2, 3, 4.5 and 6|ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.|Week 2, Month 1, 2, 3, 4.5, 6|FAS population. 'N' (number of participants analyzed)=participants who were evaluable for this measure. Missing values due to withdrawal from study or advancement to active treatment, before Month 6 was imputed using NRI method.||percentage of participants|||Number
788290|NCT00856778|Secondary|Physician Questionnaire - Virtue® Procedure Was as Easy as Competitive Therapies||At implant|||percentage of responses|||Number
788291|NCT00856778|Secondary|Physician Questionnaire - Virtue® Surgical Procedure Was Straightforward||At implant|||percentage of responses|||Number
788249|NCT00856544|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 9 and 12|ACR50 response: >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.|Month 9, 12|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed)signifies those participants who were evaluable for this measure. Missing values due to withdrawal, advancement to active treatment before Month 6 were imputed using NRI method.||percentage of participants|||Number
788250|NCT00856544|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Week 2, Month 1, 2, 3, 4.5 and 6|ACR50 response: >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.|Week 2, Month 1, 2, 3, 4.5, 6|FAS population. N (number of participants analyzed)=participants who were evaluable for this measure. Missing values due to withdrawal from study or advancement to active treatment, before Month 6 was imputed using NRI method.||percentage of participants|||Number
788251|NCT00856544|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 9 and 12|ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.|Month 9, 12|FAS population. 'N' (number of participants analyzed)=participants who were evaluable for this measure. Missing values due to withdrawal from study or advancement to active treatment, before Month 6 was imputed using NRI method.||percentage of participants|||Number
788252|NCT00856544|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Week 2, Month 1, 2, 3, 4.5 and 6|ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.|Week 2, Month 1, 2, 3, 4.5, 6|FAS population. N (number of participants analyzed)=participants who were evaluable for this measure. Missing values due to withdrawal from study or advancement to active treatment, before Month 6 was imputed using NRI method.||percentage of participants|||Number
788253|NCT00856544|Primary|Percentage of Participants Achieving Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])Less Than 2.6 at Month 6|DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, erythrocyte sedimentation rate (ESR) (millimeters/hour[mm/hour]) and patient's global assessment (PtGA) of disease activity(participant rated arthritis activity assessment). Total score range:0-9.4, higher score=more disease activity. DAS28-4 (ESR) less than or equal to (<=)3.2 implied low disease activity, greater than (>)3.2 to 5.1 implied moderate to high disease activity, less than (<)2.6=remission. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.|Month 6|FAS population included all randomized participants who received at least 1 dose of study medication. N (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal, advancement to active treatment before Month 6 were imputed using NRI method.||percentage of participants|||Number
788254|NCT00856544|Primary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities:dress/groom;arise;eat; walk;reach;grip; hygiene;common activities over past week. Each item scored on 4-point scale from 0-3:0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3:0=least difficulty and 3=extreme difficulty. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis.|Baseline, Month 3|FAS population included all randomized participants who received at least 1 dose of study medication. N (number of participants analyzed)=participants who were evaluable for this measure. Here ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
788255|NCT00856544|Primary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6|ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count (TJC); >= 20% improvement in swollen joint count (SJC); and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP). For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.|Month 6|Full analysis set (FAS) population included all randomized participants who received at least 1 dose of study medication. N (number of participants analyzed)=participants who were evaluable for this measure. Missing values due to withdrawal, advancement to active treatment before Month 6 were imputed using non-responder imputation (NRI) method.||percentage of participants|||Number
788256|NCT00856557|Secondary|Rate of Contextual Planning|Proportion of patient encounters in which the physician's plan of care addressed contextual factors identified in the audio recordings|During initial patient recordings|||proportion of physician's patients||Standard Deviation|Mean
788257|NCT00856557|Secondary|Rate of Contextual Probing|Proportion of encounters in which physician probed contextual red flags expressed by patients and identified via audio recordings.|During initial patient recordings|||proportion of physician's patients||Standard Deviation|Mean
788258|NCT00856557|Primary|Health Outcome Improvement Rate|A target health outcome improvement for each patient is prospectively defined at the first visit in which a contextual red flag is noted. The study outcome is what proportion of a physician's patients achieve their target health outcome improvement as documented in the medical record at 9 months post first visit.|After 9 months of the recorded visit|||proportion of physician's patients||Standard Deviation|Mean
788292|NCT00856778|Secondary|Assess Change in Pad Use||12 months post-implant|||pads/24 hours||Standard Deviation|Mean
788259|NCT00856583|Secondary|Number of Participants With Discontinuation of Treatment for Any Reason Other Than Study Closure|The analysis was based on time from start of study drug until stop of study drug for any reason other than sponsor closure of the study|As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months|The analysis population included all patients who took at least one dose of study drug.||participants|||Number
788260|NCT00856583|Secondary|Number of Participants With Hospitalisations, Excluding Hospitalisations Related to the Primary Psychiatric Disease|The analysis was based on time from start of study drug to first hospitalisation during the WRT+30 days period|As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months|The analysis population included all patients who took at least one dose of study drug.||participants|||Number
788261|NCT00856583|Secondary|Number of Participants With Suicide Attempts (Fatal and Non-fatal) - MedDRA|The analysis was based on all suicides and suicide attempts from the WRT+30 days period using the classification based upon MedDRA terminology, that is, as reported by the investigator|As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months|||participants|||Number
788262|NCT00856583|Secondary|Number of Participants With Suicide Attempts (Fatal and Non-fatal) - ISC|"The analysis was based on all suicides and suicide attempts from the WRT+30 days period using the classification performed by the ISC.
The ISC reviewed and classified those adverse events which resulted in death or hospitalisation or were possible suicide attempts and this review was blinded to exposure. The definition of cardiac death was intentionally wide; sudden or unexplained deaths were assumed to be cardiac if there was no non-cardiac explanation. To ensure consistent evaluation and classification, the ISC decided a priori to classify all instances of self harm as possible suicide."|As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months|The analysis population included all patients who took at least one dose of study drug.||participants|||Number
788263|NCT00856583|Secondary|Cause-specific Mortality: Number of Participants With Other Than Cardiac Deaths and Completed Suicides - MedDRA|The analysis was based on all deaths from the WRT+30 days period using the classification based upon MedDRA terminology, that is, as reported by the investigator|As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months|||participants|||Number
788264|NCT00856583|Secondary|Cause-specific Mortality: Number of Participants With Completed Suicides - MedDRA|The analysis was based on all deaths from the WRT+30 days period using the classification based upon MedDRA terminology, that is, as reported by the investigator|As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months|||participants|||Number
788265|NCT00856583|Secondary|Cause-specific Mortality: Number of Participants With Cardiac Deaths - MedDRA|The analysis was based on all deaths from the WRT+30 days period using the classification based upon the Medical Dictionary for Regulatory Activities (MedDRA) terminology, that is, as reported by the investigator|As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months|||participants|||Number
788266|NCT00856583|Secondary|Cause-specific Mortality: Number of Participants With Other Than Cardiac Deaths and Completed Suicides - ISC|"The analysis was based on all deaths from the WRT+30 days period using the classification performed by the ISC.
The ISC reviewed and classified those adverse events which resulted in death or hospitalisation or were possible suicide attempts and this review was blinded to exposure. The definition of cardiac death was intentionally wide; sudden or unexplained deaths were assumed to be cardiac if there was no non-cardiac explanation. To ensure consistent evaluation and classification, the ISC decided a priori to classify all instances of self harm as possible suicide."|As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months|||participants|||Number
788267|NCT00856583|Secondary|Cause-specific Mortality: Number of Participants With Completed Suicides - ISC|"The analysis was based on all deaths from the WRT+30 days period using the classification performed by the ISC.
The ISC reviewed and classified those adverse events which resulted in death or hospitalisation or were possible suicide attempts and this review was blinded to exposure. The definition of cardiac death was intentionally wide; sudden or unexplained deaths were assumed to be cardiac if there was no non-cardiac explanation. To ensure consistent evaluation and classification, the ISC decided a priori to classify all instances of self harm as possible suicide."|As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months|||participants|||Number
788268|NCT00856583|Primary|Second Primary Outcome: Number of Participants With Cardiac Events, Including Arrhythmias, Requiring Hospitalisation|Second primary endpoint: a serious adverse event where the patient was hospitalised and for which the Independent Safety Committee (ISC) classified the event as a cardiac event with documented arrhythmia. The analysis of this outcome was not performed due to low number of events. The presented analysis is a replacement analysis using all cardiac events, including arrhythmias, that required hospitalisation|As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months|The analysis population included all patients who took at least one dose of study drug.||participants|||Number
788293|NCT00856778|Secondary|Assess Change in Pad Use|Patients reported the average number of pads used in a 24 hour period over the 4 weeks prior to the assessment.|Baseline|There are 97 subjects with outcome 9 (baseline pad use). Of the 98 subjects implanted, one is missing the baseline assessment of pad use.||pads/24 hours||Standard Deviation|Mean
788308|NCT00856843|Secondary|Mean Change in Serum Chemistry (mg/dL)|Mean changes from Baseline to Post-preparation for the following analytes will be compared between treatment groups: blood urea nitrogen, calcium, creatinine, phosphorus. Baseline lab samples were allowed to be drawn within 15 days of the post-preparation (Visit 2) lab draw.|up to 15 days|||mg/dL||Standard Deviation|Mean
788269|NCT00856583|Secondary|Cause-specific Mortality: Number of Participants With Cardiac Deaths - ISC|"The analysis was based on all deaths from the WRT+30 days period using the classification performed by the ISC.
The ISC reviewed and classified those adverse events which resulted in death or hospitalisation or were possible suicide attempts and this review was blinded to exposure. The definition of cardiac death was intentionally wide; sudden or unexplained deaths were assumed to be cardiac if there was no non-cardiac explanation. To ensure consistent evaluation and classification, the ISC decided a priori to classify all instances of self harm as possible suicide."|As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months|The analysis population included all patients who took at least one dose of study drug.||participants|||Number
788270|NCT00856583|Primary|Number of Participants With All-cause Mortality|The analysis was based on all deaths from the Whole Randomised Treatment (WRT)+30 days period and the Only Randomised Treatment (ORT) period, respectively|As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months|The analysis population included all patients who took at least one dose of study drug.||participants|||Number
788271|NCT00856635|Secondary|To Evaluate Changes on Additional OCT Parameters and Other Visual Function and Clinical Parameters.||6 months||||||
788272|NCT00856635|Primary|Retinal Nerve Fiber Layer Thickness at Baseline and Month 6|Axonal loss in the optic nerve (due to optic neuritis) was assessed by measuring retinal nerve fiber thickness of the affected eye using optical coherence tomography (OCT) at Baseline and Month 6.|Baseline and Month 6|The modified ITT intent-to-treat (mITT) analysis set included all patients who had been randomized to the study, received at least one dose of study drug, had a baseline OCT evaluation, and had at least one non-missing post-baseline OCT evaluation.||µm||Standard Deviation|Mean
788273|NCT00856661|Secondary|Modified Ranking Scale Score (Using the Ordinal Scale)|Please see outcomes measure one for detailed description of the mRS scale|Day 90|Two and three patients from the desmoteplase and placebo group, respectively, had no valid functional assessment done. Hence, the full analysis set consisted of 124 and 128 patients, respectively.||Scores on a scale||Standard Error|Least Squares Mean
788274|NCT00856661|Secondary|Composite of mRS & NIHSS Response (Percentage of Participants With mRS Scores 0-2 and (NIHSS <= 1 or NIHSS Decrease >= 8)|Please see outcomes measure one and two for detailed description of the scales|Day 90|Two and three patients from the desmoteplase and placebo group, respectively, had no valid functional assessment done. Hence, the full analysis set consisted of 124 and 128 patients, respectively.||Percentage of participants|||Number
788275|NCT00856661|Secondary|National Institutes of Health Stroke Scale (NIHSS) Score. (Percentage of Participants With NIHSS Scores <=1 or NIHSS Decrease >=8)|The NIHSS is a clinician-rated, 15-item scale designed to assess the severity of stroke-related neurological deficits: level of consciousness, eye movements, visual fields, facial symmetry, motor strength (arm and leg), coordination, sensation, language (aphasia and dysarthria), and neglect. Each item is rated on a 3-, 4-, or 5-point scale ranging from 0 (normal) to the maximum score (extremely severe symptoms). The total score of the 15 items ranges from 0 to 42, where lower scores indicate less impairment.|90 days|Two and three patients from the desmoteplase and placebo group, respectively, had no valid functional assessment done. Hence, the full analysis set consisted of 124 and 128 patients, respectively.||Percentage of participants|||Number
788276|NCT00856661|Primary|Modified Rankin Scale Score (mRS) (Percentage of Participants With mRS Scores 0-2)|The mRS is a clinician-rated scale designed to provide a global assessment of the patients dependency after stroke. The scale consists of a single item measuring the patient’s function based on the ability to perform daily activities. The patient is rated on a 7-point scale from 0 to 6, where a score of 5 corresponds to severe disability, and 6 to death. Assessment of a pre-stroke mRS score is based on an interview addressing the status of the patient prior to the stroke|Day 90|Two and three patients from the desmoteplase and placebo group, respectively, had no valid functional assessment done. Hence, the full analysis set consisted of 124 and 128 patients, respectively.||Percentage of participants|||Number
788277|NCT00856726|Secondary|Fractional Excretion of Calcium|change in urinary fractional excretion of calcium from baseline to six hours|six hours|adult volunteers||percentage of fractional excretion||Standard Deviation|Mean
788278|NCT00856726|Secondary|Parathyroid Hormone|change in parathyroid hormone from baseline to six hours|six hours|adult volunteers||pg/ml||Standard Deviation|Mean
788279|NCT00856726|Secondary|Serum Calcium|change in serum calcium from baseline to six hours|six hours|adult volunteers||mg/dL||Standard Deviation|Mean
788280|NCT00856726|Secondary|Serum Phosphorus|change in serum phosphorus from baseline to six hours|six hours|adult volunteers||mg/dL||Standard Deviation|Mean
788281|NCT00856726|Secondary|Fibroblast Growth Factor 23|The change in fibroblast growth factor 23 concentrations from baseline to six hours|six hours|adult volunteers||relative units (RU)/ml||Standard Deviation|Mean
788282|NCT00856726|Primary|Urinary Phosphorus Excretion|Fractional excretion of phosphorus (the fraction of phosphorus filtered by the kidney which is excreted in the urine)|six hours|||percentage of fractional excretion||Standard Deviation|Mean
788283|NCT00856739|Primary|Cartilage Thickness|Medial/lateral thickness ratio|baseline or first and only visit.|Overweight and obese were combined based on similarities found in literature. Subjects were excluded based on MRI evidence of cartilage defects, osteophytes, ligament tears, meniscal tears, or bone marrow edema.||mm/mm||Standard Deviation|Mean
788284|NCT00856739|Primary|Gait Knee Adduction Moment||baseline or first and only visit.|Obese were compared to healthy weight subjects. No overweight subjects were used in this analysis. Subjects were excluded based on MRI evidence of cartilage defects, osteophytes, ligament tears, meniscal tears, or bone marrow edema.||percent body weight (N)*height (m)||Standard Deviation|Mean
788294|NCT00856778|Secondary|Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Function|The UCLA-RAND Incontinence Index is from a section within the RAND 36-item Health Survey v2 (SF-36 v2) and UCLA Prostate Cancer Index and measures a patient’s urinary habits over the 4 weeks prior to questionnaire completion and consists of 6 questions. Two scores are produced, the Urinary Bother and Urinary Function scores. The Urinary Bother score ranges from 0 to 100 with lower scores indicating worse symptoms of urinary bother. The Urinary Function score ranges from 0 to 100 with lower scores indicating worse urinary function.|12 months post implant|||units on a scale||Standard Deviation|Mean
788295|NCT00856778|Secondary|Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Function|The UCLA-RAND Incontinence Index is from a section within the RAND 36-item Health Survey v2 (SF-36 v2) and UCLA Prostate Cancer Index and measures a patient’s urinary habits over the 4 weeks prior to questionnaire completion and consists of 6 questions. Two scores are produced, the Urinary Bother and Urinary Function scores. The Urinary Bother score ranges from 0 to 100 with lower scores indicating worse symptoms of urinary bother. The Urinary Function score ranges from 0 to 100 with lower scores indicating worse urinary function.|Baseline|There are 97 subjects with outcome 7 (Urinary function at baseline). Of the 98 subjects implanted, 1 is missing the baseline Urinary Function assessment.||units on a scale||Standard Deviation|Mean
788296|NCT00856778|Secondary|Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Bother|The UCLA-RAND Incontinence Index is from a section within the RAND 36-item Health Survey v2 (SF-36 v2) and UCLA Prostate Cancer Index and measures a patient’s urinary habits over the 4 weeks prior to questionnaire completion and consists of 6 questions. Two scores are produced, the Urinary Bother and Urinary Function scores. The Urinary Bother score ranges from 0 to 100 with lower scores indicating worse symptoms of urinary bother. The Urinary Function score ranges from 0 to 100 with lower scores indicating worse urinary function.|12 months post implant|||units on a scale||Standard Deviation|Mean
788297|NCT00856778|Secondary|Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Bother|The UCLA-RAND Incontinence Index is from a section within the RAND 36-item Health Survey v2 (SF-36 v2) and UCLA Prostate Cancer Index and measures a patient’s urinary habits over the 4 weeks prior to questionnaire completion and consists of 6 questions. Two scores are produced, the Urinary Bother and Urinary Function scores. The Urinary Bother score ranges from 0 to 100 with lower scores indicating worse symptoms of urinary bother. The Urinary Function score ranges from 0 to 100 with lower scores indicating worse urinary function.|Baseline|There are 97 subjects with outcome 5 (Urinary bother at baseline). Of the 98 subjects implanted, 3 are missing the baseline Urinary Bother assessment.||units on a scale||Standard Deviation|Mean
788298|NCT00856778|Secondary|Assess Change in Subject Satisfaction Through ICIQ|The ICIQ-UI Short Form (International Consultation on Incontinence Questionnaire – Urinary Incontinence Short Form) is a brief self-assessment instrument applicable to all incontinent patients worldwide that measures the severity of urinary incontinence. The score ranges from 0 to 21 with higher number indicative of worse Urinary Incontinence severity.|12 months post implant|There are 73 subjects with outcome 4 (ICIQ at 12 months). Of the 74 subjects with 12 months follow-up, 1 is missing the 12 month ICIQ assessment.||units on a scale - ICIQ Score||Standard Deviation|Mean
788299|NCT00856778|Secondary|Assess Change in Subject Satisfaction Through ICIQ|The ICIQ-UI Short Form (International Consultation on Incontinence Questionnaire – Urinary Incontinence Short Form) is a brief self-assessment instrument applicable to all incontinent patients worldwide that measures the severity of urinary incontinence. The score ranges from 0 to 21 with higher number indicative of worse Urinary Incontinence severity.|Baseline|There are 95 subjects with outcome 3 (ICIQ at baseline). Of the 98 subjects implanted, 3 are missing the baseline ICIQ assessment.||units on a scale - ICIQ Score||Standard Deviation|Mean
788300|NCT00856778|Primary|Assess Change in 24-hour Pad Weight. Definition of Success: >50% With Outcome of Improved, Much Improved, Very Much Improved, or Cured (Dry).|"Endpoint definition: Improved = 25-49% reduction of pad weight, Much Improved = 50-89% reduction of pad weight, Very Much Improved = <12 grams or 90% reduction in pad weight, Cured = Dry. Definition of Success: >50% responding very much better or much better."|12 months|"The study was not fully enrolled and therefore underpowered for the planned analyses.
There are 71 subjects with outcome 2 (pad weight endpoint). Of the 74 with 12 months follow-up, 3 are missing the pad weight improvement assessment."||% of subjects successful||95% Confidence Interval|Number
788301|NCT00856778|Primary|Patient Satisfaction Using the Patient Global Impression of Improvement (PGI-I)|"Patient satisfaction using the Patient Global Impression of Improvement (PGI-I. Definition of Success: >50% responding very much better or much better."|12 months post implant|The study was not fully enrolled and therefore underpowered for the planned analyses.||% of subjects successful||95% Confidence Interval|Number
788302|NCT00856791|Secondary|Number of Adverse Events|The number of adverse events and their severity rating will be classified according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events, version 3.0.|6 months|||Adverse event|||Number
788303|NCT00856791|Primary|Progression Free Survival|Progression-free survival, defined as the number of days from the first day of study drug dosing to the day of documented disease progression or death, as assessed using RECIST (Response Evaluation Criteria in Solid Tumors) guidelines according to Therasse P, Arbuck SF, Eisenhauer EA, et al. (2000) J Natl Cancer Inst. 92:205-216. Progressive disease is defined as at least a 20% increase in the sum of the longest diameter (LD)of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|6 months|||day|||Number
788304|NCT00856830|Secondary|Progression Free Survival|Using the Response Evaluation Criteria in Solid Tumors (RECIST 2000), progression is defined as 20% or greater increase from the baseline tumor parameters or new lesions.|7 months|||months||95% Confidence Interval|Median
788305|NCT00856830|Primary|Number of Patients With Adverse Events - Phase II|The degree of toxicity as defined by The National Cancer Institute Common Toxicity Criteria version 3.|9 weeks|||participants|||Number
788306|NCT00856830|Primary|Number of Participants Experiencing Dose Limiting Toxicity Regimen A - Phase I|The determination of the dose limiting toxicity as defined by The National Cancer Institute Common Toxicity Criteria version 3 as follows: grade 4 neutropenia >5 days; grade 3/4 febrile neutropenia; grade 4 thrombocytopenia; or grade >2 non-hematologic toxicities (except for nausea/vomiting, alopecia, or fatigue).|9 weeks|||participants|||Number
788309|NCT00856843|Secondary|Subject Symptom Scores|Expected preparation related symptoms of Abdominal Cramping, Abdominal Bloating, Nausea and Overall discomfort were rated by each subject from 1 - 5 (1=none, 2=mild, 3=bothersome, 4=distressing, 5=severely distressing).|2 days|||units on a scale||Standard Deviation|Mean
788310|NCT00856843|Secondary|Assessment of Residual Fluid - Sigmoid Colon/Rectum|The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.|2 days|||percentage of participants|||Number
788311|NCT00856843|Secondary|Assessment of Residual Fluid - Descending Colon|The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.|2 days|||percentage of participants|||Number
788312|NCT00856843|Secondary|Assessment of Residual Fluid - Transverse Colon|The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.|2 days|||percentage of participants|||Number
788313|NCT00856843|Secondary|Assessment of Residual Fluid - Ascending Colon|The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.|2 days|||percentage of participants|||Number
788314|NCT00856843|Secondary|Assessment of Residual Fluid - Cecum|The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.|2 days|||percentage of participants|||Number
788315|NCT00856843|Secondary|Assessment of Residual Stool - Sigmoid Colon/Rectum|The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess.|2 days|||percentage of participants|||Number
788316|NCT00856843|Secondary|Assessment of Residual Stool - Descending Colon|The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess.|2 days|||percentage of participants|||Number
788317|NCT00856843|Secondary|Assessment of Residual Stool - Transverse Colon|The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess.|2 days|||percentage of participants|||Number
788318|NCT00856843|Secondary|Assessment of Residual Stool - Ascending Colon|The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess.|2 days|||percentage of participants|||Number
788319|NCT00856843|Secondary|Assessment of Residual Stool - Cecum|The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess.|2 days|||percentage of participants|||Number
788320|NCT00856843|Primary|Efficacy: Percentage of Patients With Successful Preparations Based on a 4 Point Scale|Blinded colonoscopists rated cleansing quality as either Excellent, Good, Fair or Poor. Scores of Excellent or Good were considered Successful preparations.|2 days|||percentage of participants|||Number
788321|NCT00856908|Secondary|S-C-Peptide (AUC0-24)/24, Change From Baseline to End of Treatment|Log ratio (End of treatment/Baseline) has been analysed in an ANCOVA model, using treatment as fixed factor and log(Baseline) as covariate. Resulting estimates have been back-transformed from the log-scale and then multiplied by 100 to obtain the relative ratio (end of treatment/placebo) in percent. Changes in percent have been obtained by subtraction by 100.|Baseline is the day before first dose, end of treatment is last day of treatment|||relative change in percent||95% Confidence Interval|Least Squares Mean
788322|NCT00856908|Secondary|S-Insulin (AUC0-24)/24, Change From Baseline to End of Treatment|Log ratio (End of treatment/Baseline) has been analysed in an ANCOVA model, using treatment as fixed factor and log(Baseline) as covariate. Resulting estimates have been back-transformed from the log-scale and then multiplied by 100 to obtain the relative ratio (end of treatment/placebo) in percent. Changes in percent have been obtained by subtraction by 100|Baseline is the day before first dose, end of treatment is last day of treatment|||relative change in percent||95% Confidence Interval|Least Squares Mean
788323|NCT00856908|Secondary|P-Glucose (AUC0-24)/24, Change From Baseline to End of Treatment|Log ratio (End of treatment/Baseline) has been analysed in an ANCOVA model, using treatment as fixed factor and log(Baseline) as covariate. Resulting estimates have been back-transformed from the log-scale and then multiplied by 100 to obtain the relative ratio (end of treatment/placebo) in percent. Changes in percent have been obtained by subtraction by 100.|Baseline is the day before first dose, end of treatment is last day of treatment|||relative change in percent||95% Confidence Interval|Least Squares Mean
788324|NCT00856908|Secondary|Apparent Oral Clearance of AZD1656||Measured last day of treatment|||L/h||Full Range|Mean
788325|NCT00856908|Secondary|Terminal Elimination Half-life of AZD1656||Measured following the evening dose last day of treatment|||h||Full Range|Mean
788326|NCT00856908|Secondary|Time to Reach Maximum Plasma Concentration of AZD1656||Measured last day of treatment|||h||Full Range|Median
788327|NCT00856908|Secondary|Maximum Plasma Concentration of AZD1656|Dose-adjusted to a morning dose of 50 mg due to titrated doses|Measured following the morning dose last day of treatment|||umol/L||95% Confidence Interval|Geometric Mean
788328|NCT00856908|Secondary|Area Under the Plasma Concentration vs Time Curve (AUC0-24) of AZD1656|Dose-adjusted to a total daily dose of 100 mg due to titrated doses|Measured last day of treatment|||umol*h/L||95% Confidence Interval|Geometric Mean
788329|NCT00856908|Primary|Clinically Relevant Change of Laboratory Variables|Number of participants with clinically relevant change of laboratory variables (clinical chemistry, haematology and urinalysis parameters|Measured regularly from day before first dose to day after last dose|||Participants|||Number
788330|NCT00856908|Primary|Weight, Change From Baseline to End of Treatment||Baseline is the day before first dose, end of treatment is last day of treatment|||kg||Standard Deviation|Mean
788331|NCT00856908|Primary|Pulse, Change From Baseline to End of Treatment||Baseline is pre-dose first day of dosing, end of treatment is the morning following the treatment period|||beats/min||Standard Deviation|Mean
788332|NCT00856908|Primary|Diastolic Blood Pressure, Change From Baseline to End of Treatment||Baseline is pre-dose first day of dosing, end of treatment is the morning following the treatment period|||mmHg||Standard Deviation|Mean
788333|NCT00856908|Primary|Systolic Blood Pressure, Change From Baseline to End of Treatment||Baseline is pre-dose first day of dosing, end of treatment is the morning following the treatment period|||mmHg||Standard Deviation|Mean
788334|NCT00856934|Secondary|Pain|Pain evaluated on a Visual Analog Scale (VAS) from 0 (no pain) to 10 (extreme pain), specifically during dressing replacement.|Post operative day 5|||VAS Pain Score||Standard Deviation|Mean
788335|NCT00856934|Primary|Complete Wound Healing|Time required for complete epithelialization in days|Post operative day 5 and every other day thereafter|||Days||Standard Deviation|Mean
788336|NCT00856973|Secondary|Change in School Tardiness/Attendance Reports at Week 12 (Hours)|School tardiness/attendance reports were to be collected when subject was actively enrolled in school (fall and spring semesters only; summer school, camps or other school attendance was not recorded.) The School Tardiness Report captured the number of days that the subject was tardy to school, had partial attendance at school or was completely absent from school. Data were collected for the 30-day period prior to Baseline, 6-week period prior to Week 6, 6-week period prior to Week 12.|Baseline (Day 0) to Week 12|Intent to treat population||Hours||Standard Error|Least Squares Mean
788337|NCT00856973|Secondary|Change in School Tardiness/Attendance Reports at Week 12 (Days)|School tardiness/attendance reports were to be collected when subject was actively enrolled in school (fall and spring semesters only; summer school, camps or other school attendance was not recorded.) The School Tardiness Report captured the number of days that the subject was tardy to school, had partial attendance at school or was completely absent from school. Data were collected for the 30-day period prior to Baseline, 6-week period prior to Week 6, 6-week period prior to Week 12.|Baseline (Day 0) to Week 12|Intent to treat population||Days||Standard Error|Least Squares Mean
788338|NCT00856973|Secondary|Change From Baseline to Week 12 in Subjective Number of Awakenings After Sleep Onset (NAASO).|A Sponsor produced sleep questionnaire asked the subject or parent/guardian to report information about the subject’s sleep and daytime functioning since the last visit. This questionnaire provided a subjective assessment of NAASO over a pre-defined time period.|Baseline (Day 0) to Week 12|Intent to treat population with both baseline and Week 12 Subjective Number of Awakenings After Sleep Onset (NAASO)||Number of Awakenings||Standard Error|Least Squares Mean
788339|NCT00856973|Secondary|Change From Baseline to Week 12 in Pediatric Quality-of-Life Scale (Short Form-10).|The SF 10 Health Survey for Children is a 10 item care-giver completed assessment designed to measure children’s health-related quality of life. The scale asked questions about the child’s physical wellness, feelings, behavior, and activities at school and with family and friends. The SF 10 Physical and Psychosocial summary measures were scored such that higher scores indicated more favorable functioning.|Baseline (Day 0) to Week 12|Intent to treat population with both baseline and Week 12 Pediatric Quality-of-Life Scale (Short Form-10)||units on a scale||Standard Error|Least Squares Mean
788340|NCT00856973|Secondary|Change From Baseline to Week 12 in Coding Copy Subtest / Digit Symbol Substitution Test (DSST) Scaled Score.|These tests are standardized information processing tasks to assess recognition and recoding of sensory information. The subject was given 90 seconds to complete as many substitutions of symbols as possible according to a code provided on top of the sheet. The Coding Copy Subtest A was used for subjects 6-7 years of age and the Coding Copy Subtest B was used for subjects 8-16 years of age, and the DSST was used for subjects 17 years of age. The score is the number of squares filled in correctly. Individuals are measured against their own pre-treatment baseline to determine levels of impairment using the scaled score. Higher scores mean less impairment (or potentially improvement) as the number of correct substitutions generally improves as cognition improves. Scaled scores are used to account for age differences among test takers. Scaled scores range from 1 to 19, and higher scores indicate higher cognitive function.|Baseline (Day 0) to Week 12|Intent to treat population with both baseline and Week 12 Coding Copy Subtest / Digit Symbol Substitution Test (DSST) Scaled Score||Score||Standard Error|Least Squares Mean
788341|NCT00856973|Secondary|Change From Baseline to Week 12 in Pediatric Daytime Sleepiness Scale (PDSS) Total Score.|The PDSS is a validated measure of excessive sleepiness specifically designed for use in school aged children. The scale allowed for measurement of sleepiness across several relatively sedentary activities and provided a means to unmask sleepiness that may not be recognized during more active situations. It consisted of 8 items that assessed the frequency of a sleep related behavior (eg, how often do you fall asleep or get drowsy during class periods; are you usually alert most of the day; how often do you think you need more sleep) using a 5-point Likert type scale (0 = never, 4 = always). All items were summed to obtain the PDSS total score. PDSS data were used for efficacy evaluation as well as for the evaluation of residual effects.The overall PDSS scores range from a low of 0 where the individual is endorsing each item at the lowest level of sleepiness to a high of 32 where the individual is endorsing each item at the highest level of sleepiness.|Baseline (Day 0) to Week 12|Intent to treat population with both baseline and Week 12 in Pediatric Daytime Sleepiness Scale (PDSS) Total Score||units on a scale||Standard Error|Least Squares Mean
788342|NCT00856973|Secondary|Change From Baseline to Week 11 in Total Sleep Time (TST) Measured by Actigraphy Monitoring in the Actigraphy Population.|A central scoring facility was used to derive the actigraphy sleep parameter of Total Sleep Time (TST). Actigraphy data were used for additional efficacy evaluation as well as for the evaluation of rebound and withdrawal effects.|Baseline (Day 0) to Week 11|The Actigraphy population included subjects in the ITT population for whom actigraphy data had been collected. All efficacy analyses of actigraphy data were performed using this population||Minutes||Standard Error|Least Squares Mean
788343|NCT00856973|Secondary|Change From Baseline to Week 11 in Subjective WASO From Actigraphy Population.|A central scoring facility was used to derive the actigraphy sleep parameters Wake Time After Sleep Onset (WASO). Actigraphy data were used for additional efficacy evaluation as well as for the evaluation of rebound and withdrawal effects.|Baseline (Day 0) to Week 11|Actigraphy population which included subjects in the ITT population for whom actigraphy data had been collected. All efficacy analyses of actigraphy data were performed using this population||Minutes||Standard Error|Least Squares Mean
788344|NCT00856973|Secondary|Change From Baseline to Week 11 in Subjective Sleep Latency (SL) Measured by Actigraphy Monitoring in the Actigraphy Population.|A central scoring facility was used to derive the actigraphy sleep parameter of Sleep Latency (SL). Actigraphy data were used for additional efficacy evaluation as well as for the evaluation of rebound and withdrawal effects.|Baseline (Day 0) to Week 11|The Actigraphy population included subjects in the ITT population for whom actigraphy data had been collected. All efficacy analyses of actigraphy data were performed using this population||Minutes||Standard Error|Least Squares Mean
788345|NCT00856973|Secondary|Change From Baseline to Week 12 in Subjective Total Sleep Time (TST).|A Sponsor produced sleep questionnaire asked the subject or parent/guardian to report information about the subject’s sleep and daytime functioning since the last visit. This questionnaire provided a subjective assessment of TST over a pre-defined time period. TST is subjective total sleep time.|Baseline (Day 0) to Week 12|Intent to treat population with both baseline and Week 12 subjective Total Sleep Time||Minutes||Standard Error|Least Squares Mean
788346|NCT00856973|Secondary|Change From Baseline to Week 12 in PSG Defined Total Sleep Time (TST)|A central scoring facility was used to derive the PSG sleep parameter of Total Sleep Time (TST) from the epochs and stages collected via the PSG recordings. The PSG parameters provided an objective assessment of the subject’s sleep on a given night. Total sleep time was defined as the number of non-wake epochs from the beginning of recording to the end of recording divided by 2. If total recording time was greater than 960 epochs (480 minutes), total sleep time was calculated from the PSG truncated at 480 minutes.|Baseline (Day 0) to Week 12|Intent to treat population with both baseline and Week 12 PSG defined Total Sleep Time||Minutes||Standard Error|Least Squares Mean
788347|NCT00856973|Secondary|Change From Baseline to Week 12 in PSG Defined Number of Awakenings After Sleep Onset (NAASO).|A central scoring facility was used to derive the PSG sleep parameter of Number of Awakenings after Sleep Onset (NAASO). The PSG parameters provided an objective assessment of the subject’s sleep on a given night. Number of awakenings: The number of times, after onset of persistent sleep, that there was a wake entry of at least one-minute duration. Each awakening must have been separated by an epoch of non rapid eye movement (NREM) sleep stage 2, 3/4, or rapid eye movement (REM) sleep.|Baseline (Day 0) to Week 12|Intent to treat population with both baseline and Week 12 PSG defined of Awakenings After Sleep Onset||Number of Awakenings after sleep onse||Standard Error|Least Squares Mean
788348|NCT00856973|Secondary|Change From Baseline to Week 12 in PSG Defined Sleep Efficiency (SE)|A central scoring facility was used to derive the PSG sleep parameter of Sleep Efficiency (SE) from the epochs and stages collected via the PSG recordings. The PSG parameters provided an objective assessment of the subject’s sleep on a given night. Sleep efficiency: (total sleep time)/(total recording time) x 100. For this endpoint, total sleep time was defined as the number of non-wake epochs from the beginning of recording to the end of recording divided by 2. If total recording time was greater than 960 epochs (480 minutes), total sleep time was calculated from the PSG truncated at 480 minutes.|Baseline (Day 0) to Week 12|Intent to treat population with both baseline and Week 12 PSG defined sleep efficiency||percentage of SE||Standard Error|Least Squares Mean
788349|NCT00856973|Secondary|Change From Baseline to Week 12 in Subjective Wake Time After Sleep Onset (WASO).|A Sponsor produced sleep questionnaire asked the subject or parent/guardian to report information about the subject’s sleep and daytime functioning since the last visit. This questionnaire provided a subjective assessment of WASO over a pre-defined time period. WASO is the aggregate duration of awakenings from the time subjects fall asleep until last awakening. Wake time after sleep onset (WASO; minutes): The number of wake epochs after the onset of persistent sleep to the end of the recording, divided by 2.|Baseline (Day 0) to Week 12|Intent to treat population with both baseline and Week 12 subjective WASO||Minutes||Standard Error|Least Squares Mean
788350|NCT00856973|Secondary|Change From Baseline to Week 12 in Subjective SL (Sleep Latency)|A Sponsor produced sleep questionnaire asked the subject or parent/guardian to report information about the subject’s sleep and daytime functioning since the last visit. This questionnaire provided a subjective assessment of SL over a pre-defined time period. SL is subjective time to fall asleep.|Baseline (Day 0) to Week 12|Intent to treat population with both baseline and Week 12 Subjective sleep latency||Minutes||Standard Error|Least Squares Mean
788351|NCT00856973|Secondary|Change From Baseline (Day 0) to Week 12 in Conners' ADHD Inattention Rating Scale.|The Conners’ 3 –Parent Short Form was completed by the parent and provided an assessment of Attention-Deficit/ Hyperactivity Disorder (ADHD) and the most common comorbid problems and disorders in children and adolescents. It is a multi-informant assessment of children and adolescents between 6 and 18 years of age that took into account home, social and school settings. The short version of the Conners’ 3 –Parent Short Form was a subset of items from the full-length form, and included the Conners’ 3 Content Scales of Inattention, Hyperactivity/Impulsivity, Learning Problems, Executive Functioning, Aggression, and Peer/Family Relations. The scale scores were presented as standardized age and gender based t scores. Inattention score was used for this endpoint. The lowest scale score is 40 (best) and the highest is 90 (worse)].|Baseline (Day 0) to Week 12|Intent to treat population with both baseline and Week 12 Conners’ ADHD Inattention rating scale||units on a scale||Standard Error|Least Squares Mean
788352|NCT00856973|Secondary|Change From Baseline in CGI-Child at Week 12|The CGI - I Child was completed by the investigator based on interviews and interactions with the subject and represented the subject’s assessment of improvement in his/her symptoms since the start of the study. A 7 point scale was used for improvement with numeric values assigned to each of the responses: very much improved (1), much improved (2), minimally improved (3), no change (4), minimally worse (5), much worse (6), and very much worse (7).|Baseline (Day 0) to Week 12|Intent to treat population with Week 12 CGI Improvement from Child||Units on a scale||Standard Error|Least Squares Mean
788353|NCT00856973|Secondary|Change From Baseline in Clinical Global Improvement (CGI)-Parent/Caregiver at Week 12|The CGI-I Parent/Caregiver was completed by the investigator based on interviews and interactions with the subject’s parent or caregiver and represented their assessment of severity and improvement in the subject’s symptoms since the start of the study. A 7 point scale was used for improvement with numeric values assigned to each of the responses: very much improved (1), much improved (2), minimally improved (3), no change (4), minimally worse (5), much worse (6), and very much worse (7).|Baseline (Day 0) to Week 12|Intent to treat population with Week 12 CGI Improvement from Parent/Caregiver||Units on a scale||Standard Error|Least Squares Mean
788354|NCT00856973|Secondary|Change From Baseline (Day 0) to Week 12 in PSG Defined Wake Time After Sleep Onset (WASO)|A central scoring facility was used to derive the PSG sleep parameters Wake Time After Sleep Onset (WASO) from the epochs and stages collected via the PSG recordings. Each epoch is 30 seconds. The PSG parameters provided an objective assessment of the subject’s sleep on a given night. Change from BL at Week 12 in WASO was derived from Week 12 WASO subtracted by BL WASO. Wake time after sleep onset (WASO; minutes): The number of wake epochs after the onset of persistent sleep to the end of the recording, divided by 2.|Baseline (Day 0) to Week 12|Intent to treat population with both baseline and Week 12 WASO||Minutes||Standard Error|Least Squares Mean
788373|NCT00856986|Secondary|Mean Changes From Randomisation in Cholesterol Lipids at Week 52.|Cholesterol Lipids cover: Total Cholesterol, Low-density Lipoprotein Cholesterol (LDL-C), Very Low Density Lipoprotein Cholesterol (VLDL-C), High Density Lipoprotein Cholesterol (HDL-C)|Week 0, Week 52|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)||mmol/L||Standard Error|Least Squares Mean
788355|NCT00856973|Primary|Change From Baseline to the End of the Double- Blind Treatment Period (Week 12) in Polysomnography (PSG) Defined Latency to Persistent Sleep (LPS).|A central scoring facility was used to derive the PSG sleep parameters Latency to Persistent Sleep (LPS) from the epochs and stages collected via the PSG recordings. Each epoch is 30 seconds. The PSG parameters provided an objective assessment of the subject’s sleep on a given night. Change from BL at Week 12 in LPS was derived from Week 12 LPS subtracted by BL LPS. Latency to persistent sleep (LPS; minutes): time from lights out to the first of 20 consecutive epochs (10 minutes) of non-wake, as determined by PSG recordings.|Baseline (Day 0) to Week 12|Intent to treat (ITT) population with both baseline and week 12 LPS. ITT refers to only the subjects who were randomized AND had taken at least one dose of study drug during the doubleblind treatment period.||minutes||Standard Error|Least Squares Mean
788356|NCT00856986|Secondary|Hypoglycaemic Episodes Weeks 0-52|Number of hypoglycaemic episodes from Week 0 to Week 52, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|Week 0-52|The Safety Analysis Set included all exposed subjects. An outlier subject from the lira 1.8 group, who experienced an extreme number of minor and symptoms only hypoglycaemic episodes was excluded from this analysis||episodes|||Number
788357|NCT00856986|Secondary|Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26|Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|weeks 0-26|The Safety Analysis Set included all exposed subjects. An outlier subject from the lira 1.8 group, who experienced an extreme number of minor and symptoms only hypoglycaemic episodes was excluded from this analysis.||episodes|||Number
788358|NCT00856986|Secondary|Adverse Events From Run-in (Week -12) to Week 52||Run-in (week -12) to Week 52|The Safety Analysis Set included all exposed subjects||events|||Number
788359|NCT00856986|Secondary|Mean Change From Randomisation in Blood Pressure (Systolic and Diastolic) at Week 52.||Week 0, Week 52|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)||mmHg||Standard Error|Least Squares Mean
788360|NCT00856986|Secondary|Mean Change From Randomisation in Blood Pressure (Systolic and Diastolic) at Week 26.||Week 0 (Randomisation), Week 26|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)||mmHg||Standard Error|Least Squares Mean
788361|NCT00856986|Secondary|Mean Change From Randomisation in Waist to Hip Ratio at Week 52|Waist to Hip Ratio is calculated by dividing Waist circumference with Hip circumference|Week 0, Week 52|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)||cm/cm||Standard Error|Least Squares Mean
788362|NCT00856986|Secondary|Mean Change From Randomisation in Waist to Hip Ratio at Week 26|Waist to Hip Ratio is calculated by dividing Waist circumference with Hip circumference|Week 0 (Randomisation), Week 26|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)||cm/cm||Standard Error|Least Squares Mean
788363|NCT00856986|Secondary|Mean Change From Randomisation in Hip Circumference at Week 52||Week 0, week 52|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)||cm||Standard Error|Least Squares Mean
788364|NCT00856986|Secondary|Mean Change From Randomisation in Hip Circumference at Week 26||Week 0 (Randomisation), Week 26|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)||cm||Standard Error|Least Squares Mean
788365|NCT00856986|Secondary|Mean Change From Randomisation in Waist Circumference at Week 52.||Week 0, Week 52|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)||participants||Standard Error|Least Squares Mean
788366|NCT00856986|Secondary|Mean Change From Randomisation in Waist Circumference at Week 26.||Week 0 (Randomisation), Week 26|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)||cm||Standard Error|Least Squares Mean
788367|NCT00856986|Secondary|Mean Change From Randomisation in Body Weight at Week 52||Week 0, Week 52|The FAS (Full Analysis Set) using LOCF (last observation carried forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)||kg||Standard Error|Least Squares Mean
788368|NCT00856986|Secondary|Mean Change From Randomisation in Body Weight at Week 26||Week 0 (Randomisation), Week 26|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)||kg||Standard Error|Least Squares Mean
788369|NCT00856986|Secondary|Mean Change From Randomisation in Lipids: Free Fatty Acids (FFA) at Week 52||Week 0, Week 52|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)||mmol/L||Standard Error|Least Squares Mean
788370|NCT00856986|Secondary|Mean Change From Randomisation in Lipids: Free Fatty Acids (FFA) at Week 26||Week 0 (Randomisation), Week 26|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)||mmol/L||Standard Error|Least Squares Mean
788371|NCT00856986|Secondary|Mean Change From Randomisation in Lipids: Triglycerides at Week 52||Week 0, Week 52|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)||mmol/L||Standard Error|Least Squares Mean
788372|NCT00856986|Secondary|Mean Change From Randomisation in Lipids: Triglycerides at Week 26||Week 0 (Randomisation), Week 26|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)||mmol/L||Standard Error|Least Squares Mean
788374|NCT00856986|Secondary|Mean Changes From Randomisation in Cholesterol Lipids at Week 26.|Cholesterol Lipids cover: Total Cholesterol, Low-density Lipoprotein Cholesterol (LDL-C), Very Low Density Lipoprotein Cholesterol (VLDL-C), High Density Lipoprotein Cholesterol (HDL-C)|Week 0 (Randomisation), Week 26|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)||mmol/L||Standard Error|Least Squares Mean
788375|NCT00856986|Secondary|Mean Change From Randomisation in Fasting C-peptide at Week 52.||Week 0, Week 52|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)||mmol/L||Standard Error|Least Squares Mean
788376|NCT00856986|Secondary|Mean Change From Randomisation in Fasting C-peptide at Week 26.||Week 0 (Randomisation), Week 26|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)||mmol/L||Standard Error|Least Squares Mean
788377|NCT00856986|Secondary|Mean Change From Randomisation in Fasting Pro-insulin at Week 52||Week 0, Week 52|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)||pmol/L||Standard Error|Least Squares Mean
788378|NCT00856986|Secondary|Mean Change From Randomisation in Fasting Pro-insulin at Week 26.||Week 0 (Randomisation), Week 26|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)||pmol/L||Standard Error|Least Squares Mean
788379|NCT00856986|Secondary|Mean Change From Randomisation in Fasting Insulin at Week 52||Week 0 (Randomisation), Week 52|Data on fasting insulin could not be obtained for the insulin detemir+liraglutide 1.8 mg+metformin (Detemir + Lira 1.8 group) treated subjects due to cross-reactivity between insulin detemir and the insulin assay. Data from both goups were therefore not further investigated by ANCOVA why no data is presented for this endpoint.|||||
788380|NCT00856986|Secondary|Mean Change From Randomisation in Fasting Insulin at Week 26||Week 0 (Randomisation), Week 26|Data on fasting insulin could not be obtained for the insulin detemir+liraglutide 1.8 mg+metformin (Detemir + Lira 1.8 group) treated subjects due to cross-reactivity between insulin detemir and the insulin assay. Data from both goups were therefore not further investigated by ANCOVA why no data is presented for this endpoint.|||||
788381|NCT00856986|Secondary|Mean Change From Randomisation in 7-point Plasma Glucose Profile (Self-measured) at Week 52|Calculated as an estimate of the change in mean prandial increment of plasma glucose after breakfast, lunch and dinner (from baseline (week 0) to 52 weeks), respectively. Prandial increments of plasma glucose were calculated as the difference between glucose values measured before and after each of these three meals, respectively.|Week 0, Week 52|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)||mmol/L||Standard Error|Least Squares Mean
788382|NCT00856986|Secondary|Mean Change From Randomisation in 7-point Plasma Glucose Profile (Self-measured) at Week 26|Calculated as an estimate of the change in mean prandial increment of plasma glucose after breakfast, lunch and dinner (from baseline/randomisation (week 0) to 26 weeks), respectively. Prandial increments of plasma glucose were calculated as the difference between glucose values measured before and after each of these three meals, respectively.|Week 0 (Randomisation), Week 26|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)||mmol/L||Standard Error|Least Squares Mean
788383|NCT00856986|Secondary|Mean Change From Randomisation in Fasting Plasma Glucose at Week 52||Week 0, Week 52|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)||mmol/L||Standard Error|Least Squares Mean
788384|NCT00856986|Secondary|Mean Change From Randomisation in Fasting Plasma Glucose at Week 26||Week 0 (Randomisation), Week 26|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)||mmol/L||Standard Error|Least Squares Mean
788385|NCT00856986|Secondary|Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (Values Before Intensification as LOCF)||Week 0, Week 52|The FAS (Full Analysis Set) includes LOCF of last observation before intensification for randomised Lira 1.8 mg treatment group subjects who were intensified.||Percentage point of total HbA1c||Standard Error|Least Squares Mean
788386|NCT00856986|Secondary|Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (for Intensified Subjects in Original Treatment Group)||Week 0, Week 52|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)||Percentage point of total HbA1c||Standard Error|Least Squares Mean
788387|NCT00856986|Primary|Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 26.||Week 0 (Randomisation), week 26|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)||Percentage point of total HbA1c||Standard Error|Least Squares Mean
788418|NCT00857246|Secondary|Rate of Potentially Curative Surgery|This is defined as the percentage of patients who underwent curative surgery (surgery to remove all cancerous tissue).|4 months from the beginning of the induction treatment|patients who underwent surgery||percentage of participants|||Number
788419|NCT00857246|Secondary|Rate of Clearance of Nodal Involvement Among Patients Who Have Received the Induction Therapy|This is defined as the percentage of patients whose nodal involvement of cancer has been cleared based on surgery results.|4 months from the beginning of the induction treatment|Evaluable patients (known pre-treatment clinical and post-treatment pathologic stages)||percentage of participants|||Number
788523|NCT00858013|Secondary|HbA1c|HbA1c (%) at 24 months|at 24 months|data of participants who finished 24 months of follow-up||% HbA1c||Standard Deviation|Mean
789149|NCT00861471|Secondary|Time to PSA Progression|Time to PSA pregression is defined as the time at which therapy statred and ends when the PSA increased by 50% above the nadir confirmed on a second determination.|up to 2 years|Based on intent-to-treat population||days||95% Confidence Interval|Mean
788408|NCT00857233|Primary|Percentage of Patients Who Withdrew Due to Intolerance to Treatment||Baseline to Week 24|APTS||percentage of participants|||Number
788409|NCT00857233|Secondary|Long-term Efficacy of Memantine on Functioning Using the Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) 19-item Version Total Score|"Change from Baseline on the ADCS-ADL 19-item version total score. Analysed by descriptive methods only.
ADCS-ADL- 19 items version for moderate to severe AD will measure patient's functioning. This battery of ADL questions is used here to measure the functional capabilities of patients with dementia. The inventory is done by interviewing a person in close contact with the patient and covers the most usual and consistent performance of the patient over the preceding 4 weeks. Total score is from 0 to 54. The higher score, the lower impairment."|Baseline and Week 24|APTS; OC||Scores on a scale||Standard Deviation|Mean
788410|NCT00857233|Secondary|Long-term Efficacy of Memantine on Global Condition Using the Clinician's Interview-Based Impression of Change-Plus Version (CIBIC-plus).|"CIBIC-plus. Improvement evaluated with reference to Baseline. Analysed by descriptive methods only.
CIBIC-plus is a global rating that is derived through an independent, comprehensive interview with the patient and caregiver by a rater who is barred from knowledge of all other psychometric test scores conducted as part of this protocol as well as from reported safety data. The rating is made on a 7-point scale ranging from 1 = marked improvement to 7 = marked worsening. A score of 4 indicates no change."|Week 24|APTS; OC||Scores on a scale||Standard Deviation|Mean
788411|NCT00857233|Secondary|Long-term Efficacy of Memantine on Cognition Using the Severe Impairment Battery (SIB) Total Score.|"Change from Baseline in the SIB total score. Analysed by descriptive methods only.
SIB is a validated scale used to assess cognitive function in patients with moderate to severe dementia. Items are single words or one-step commands combined with gestures. Nine domains are assessed, and the total score is between 0 and 100. A lower total score reflects the loss of cognitive function."|Baseline and Week 24|APTS; OC||Scores on a scale||Standard Deviation|Mean
788412|NCT00857233|Secondary|Long-term Efficacy of Memantine on Behavioural Symptoms Using the Neuropsychiatric Inventory (NPI) - 12 Items Version Total Score.|"Change from Baseline in the NPI total score. Analysed by descriptive methods only.
NPI is a validated scale that assesses behavioural disturbances in patients with dementia. The 12 item version consists of 10 behavioural and 2 neurovegetative areas. It provides both a total score as well as scores for a number of sub-scales. The frequency, severity and caregiver distress for each domain are measured. The NPI is based upon responses obtained from the caregiver. The total score is from 0 to 144. A higher score reflects more frequency and severity of the disturbances."|Baseline and Week 24|APTS; Observed cases (OC)||Scores on a scale||Standard Deviation|Mean
788413|NCT00857233|Primary|Number of Patients With Adverse Events (AEs)|Overview of AEs|Baseline to Week 24|Completers from lead-in study 10158 were eligible for this open-label extension study. We analysed the All-patients-treated Set (APTS) - all patients who took at least one dose of investigational medicinal product (IMP)||participants|||Number
788414|NCT00857246|Secondary|Median Overall Survival (Adjuvant Therpary)|This is the length of time from the start of treatment that half of the patients are still alive.|up to 5 years|Patients who received at least one cycle of adjuvant therapy||months||Full Range|Median
788415|NCT00857246|Secondary|Median Overall Survival (Induction Treatment and Curative Surgery)|This is the length of time from the start of treatment that half of the patients are still alive.|up to 5 years|Patients who completed induction treatment and underwent curative surgery||months||Full Range|Median
788416|NCT00857246|Secondary|Safety of the Induction Regimen|This describes the number of patients who experienced grade 3 and higher adverse events related to the regimen.|4 months from the beginning of the induction|Patients who had at least a dose of treatment||participants|||Number
788417|NCT00857246|Secondary|"Rate of Down-staging From Pre-operative Clinical Staging"|This is defined as the percentage of patients who had a reduction from T3/T4 disease.|4 months from the beginning of the induction treatment|Evaluable patients (known pre-treatment clinical and post-treatment pathologic stages)||percentage of participants|||Number
789187|NCT00861692|Primary|Number of Patients With Thrombosis (New and Extended)||During and 30 days after argatroban treatment|||participants|||Number
788420|NCT00857246|Primary|Clinical Response Rate of an Induction Regimen Consisting of Irinotecan, Cisplatin and Cetuximab|Clinical response rate is defined as the percentage of patients who responded to the induction regimen. The response is determined based on endoscopic ultrasonography (EUS) staging pre-treatment and post-treatment, CT scans pre- and post- operatively, and initial clinical stage (based on these tests) compared with the pathologic stage. Any “down-staging” of T or N stage is considered to be a result of induction therapy and counted as a clinical response.|4 months from the beginning of the induction regimen|Evaluable patients (known pre-treatment clinical and post-treatment pathologic stages)||percentage of paticipants|||Number
788421|NCT00857259|Secondary|Change in Visual Acuity From Baseline to Week 4 in Patients Treated With Everolimus|Best corrected visual acuity (BCVA) was assessed on both eyes. BCVA measurements were taken in sitting position using Early Treatment Diabetic Retinopathy Study (ETDRs)-like visual acuity testing charts at an initial testing distance specific to test charts. BCVA is measured from the number of letters the patient can read on the eye chart.|Baseline and week 4|The Per Protocol Analysis Set (PPAS)consisted of all patients in the Full Analysis Set (FAS)who received study drug, completed the treatment phase of the trial without clinically significant protocol deviations and had non-missing central retinal thickness values for the study eye at both baseline and Day 28.||Letters||Standard Deviation|Mean
788422|NCT00857259|Primary|Change in Central Retinal Thickness From Baseline to Week 4, as Measured by Optical Coherence Tomography (OCT)|Central retinal thickness was assessed by Optical coherence tomography (OCT). The primary thickness endpoint was the mean thickness of the foveal field of the macula map produced by the analysis of the sequence of six radial scans. Foveal field thickness was the average thickness of a circular field with a diameter of 1 mm. OCT images were analyzed by a central reading center.|Baseline and 4 weeks|The Per Protocol Analysis Set (PPAS)consisted of all patients in the Full Analysis Set (FAS)who received study drug, completed the treatment phase of the trial without clinically significant protocol deviations and had non-missing central retinal thickness values for the study eye at both baseline and Day 28.||µm||Standard Deviation|Mean
788423|NCT00857272|Primary|Efficacy: Percentage of Patients With Successful Preparations Based on a 4 Point Scale|Cleansing was scored with a four point scale used in previous bowel cleansing studies where 4 = “excellent” (no more than small bits of adherent feces/fluid); 3 = “good” (small amounts of feces or fluid not interfering with the exam); 2 = “fair” (enough feces or fluid to prevent a completely reliable exam); 1 = “poor” (large amounts of fecal residue requiring additional cleansing). For the primary efficacy endpoint (preparation success), grades of 4 and 3 were considered a “success” and grades of 2 or 1 were considered a “failure”.|during colonoscopy|The analysis population consists of patients that were randomized and took any portion of the study preparation and who did not discontinue prior to colonoscopy due to a reason of safety or efficacy.||percent of participants||95% Confidence Interval|Number
788424|NCT00857285|Primary|Mean Change of Sitting dBP From Baseline to Week 12|The difference in the sitting diastolic blood pressure (dBP) at trough, i.e. 24±2 hours after drug administration, from base line to Week 12.|Baseline to 12 weeks|Four randomized subjects (3 in olmesartan, 1 in losartan) were excluded from the analysis due to a lack of post-treatment efficacy evaluation.||mmHg||Standard Error|Mean
788425|NCT00857311|Primary|Number of Participants With Vaccine-related Clinical (Systemic and Injection-site), and Laboratory Adverse Events (AE)|"Serious and non serious clinical (systemic and injection-site AEs), and laboratory AEs were collected. Systemic and laboratory AEs reflect any unfavorable & unintended change in the structure, function, or chemistry of the body. Injection-site AEs include any swelling, redness, pain or tenderness at the injection site.
Vaccine-related AEs are those determined by the investigator to be possibly, probably, or definitely related to the administration of the vaccine."|up to Week 78 (52 weeks after boost injection) for systemic AEs, 29 days after any dose for laboratory AEs, and 5 days after any dose for injection-site AEs|||Participants|||Number
788426|NCT00857311|Secondary|Immune Response by Levels of Unfractionated Gag-specific IFN-gamma Following a 3-dose Vaccine Regimen|"Participants expressing HIV antigens (gag) secrete antigen specific interferon-gamma (IFN-gamma). Levels of unfractionated gag-specific IFN-gamma were to be measured using an Enzyme Linked Immunospot Assay (ELISPOT), which measures spot forming cells per 10^6 peripheral blood mononuclear cells (SFC per million PBMCs).
No immunogenicity analyses were performed because the results from a previous study, V520-023 (NCT00095576), which used the same vaccine as the one used in this study (NCT00857311) proved it was not efficacious."|Week 30 (4 weeks after boost injection)|No analysis was performed.|||||
788427|NCT00857311|Secondary|Number of Participants With Systemic and Laboratory Adverse Events (AE)|Adverse experiences collected include serious and non serious systemic AEs, injection-site AEs, and laboratory AEs. Systemic and laboratory AEs include any unfavorable & unintended change in the structure, function, or chemistry of the body. Injection-site AEs include any swelling, redness, pain or tenderness at the injection site. All injection site AEs were collected up to 5 days after any vaccine dose.|up to Week 260 (234 weeks after boost injection) for systemic AEs, 29 days after any dose for laboratory AEs, and 5 days after any dose for injection-site AEs|||Participants|||Number
788428|NCT00857415|Secondary|Regional Correlation Analysis|Spearman's rank order correlation of median visual read of the florbetapir-PET image vs. amyloid plaque density assessed post-mortem by quantitative IHC of six individual brain regions (precuneus, parietal cortex, frontal cortex, temporal cortex, posterior cingulate, anterior cingulate). Spearman's rank order correlation ranges from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation.|at autopsy up to 12 months post-scan|All subjects with a valid image who came to autopsy within 1 year of scan, minus 6 subjects who served as front-runners||Correlation coefficient||95% Confidence Interval|Number
788429|NCT00857415|Primary|Specificity Analysis|Specificity of florbetapir-PET scan in younger healthy controls presumed to be negative for amyloid. Specificity results are reported as the number of subjects who had a negative scan based on majority of 3 blinded readers.|50-60 min after injection|Per protocol, 27 subjects who were genetic carriers for ApoE e4 or whose genetic status was unknown were excluded from the analysis||participants|||Number
788524|NCT00858013|Primary|The Durability of Nateglinide in Comparison With Those of Glimepiride Based on the Withdrawal Rate|% monotherapy failure, that means % number of participants who withdrew from the study due to high HbA1c (>8.0%)|every 3 months following randomization, for 24 months|||Participants|||Count of Participants
789188|NCT00861692|Primary|Death Related to Heparin-induced Thrombocytopenia (HIT)||During and 30 days after argatroban treatment|||participants|||Number
788430|NCT00857415|Primary|Correlation of Florbetapir-PET Image and Amyloid Plaque Density|Spearman's rank order correlation of the median semi-quantitative visual read of the florbetapir-PET image and the amyloid plaque density assessed post-mortem by quantitative immunohistochemistry (IHC) averaged across 6 brain regions (precuneus, parietal cortex, frontal cortex, temporal cortex, posterior cingulate, anterior cingulate). Spearman's rank order correlation ranges from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation.|at autopsy up to 12 months post-scan|All subjects with a valid image who came to autopsy within 1 year of scan, minus 6 subjects who served as front-runners||Correlation coefficient||95% Confidence Interval|Number
788431|NCT00857454|Secondary|Change From Baseline MTE08 to MTE09 Follow-up in Hematocrit||Day 1, up to Day 190|Participants enrolled in the study who had a baseline on MTE08 (Day 1) and a measurement at endpoint (Day 180) or Follow-Up/Early Withdrawal (Day 190).||percentage of red blood cells in sample||Standard Deviation|Mean
788432|NCT00857454|Secondary|Change From Baseline MTE08 to MTE09 Follow-up in Hemoglobin||Day 1, up to Day 190|Participants enrolled in the study who had a baseline on MTE08 (Day 1) and a measurement at endpoint (Day 180) or Follow-Up/Early Withdrawal (Day 190).||grams per deciliter (g/dL)||Standard Deviation|Mean
788433|NCT00857454|Secondary|Change From Baseline MTE08 to MTE09 Follow-up in Estradiol||Day 1, up to Day 190|Participants enrolled in the study who had a baseline on MTE08 (Day 1) and a measurement at endpoint (Day 180) or Follow-Up/Early Withdrawal (Day 190).||picograms per milliliter (pg/mL)||Standard Deviation|Mean
788434|NCT00857454|Secondary|Change From Baseline MTE08 to MTE09 Follow-up in Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH)||Day 1, up to Day 190|Participants enrolled in the study who had a baseline on MTE08 (Day 1) and a measurement at endpoint (Day 180) or Follow-Up/Early Withdrawal (Day 190).||mIU/mL||Standard Deviation|Mean
788435|NCT00857454|Secondary|Change From Baseline MTE08 to MTE09 Follow-up in Prostatic Specific Antigen (PSA)||Day 1, up to Day 190|Participants enrolled in the study who had a baseline on MTE08 (Day 1) and a measurement at endpoint (Day 180) or Follow-Up/Early Withdrawal (Day 190).||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
788436|NCT00857454|Secondary|Change From Baseline MTE08 to MTE09 Follow-up in Fasting Glucose||Day 1, up to Day 190|Participants enrolled in the study who had a baseline on MTE08 (Day 1) and a measurement at endpoint (Day 180) or Follow-Up/Early Withdrawal (Day 190).||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
788437|NCT00857454|Secondary|Change From Baseline MTE08 to MTE09 Follow-up in Fasting Insulin||Day 1, up to Day 190|Participants enrolled in the study who had a baseline on MTE08 (Day 1) and a measurement at endpoint (Day 180) or Follow-Up/Early Withdrawal (Day 190).||uIU/mL||Standard Deviation|Mean
788438|NCT00857454|Primary|Change From Baseline MTE08 to MTE09 Endpoint in Draize Score|Draize score is a measurement of skin irritability of the application site based on erythema/escar and oedema. Erythema/eschar scoring ranges from 0 (no erythema) to 4 (severe erythema [beet redness] to slight eschar formation [injuries in depth]). Oedema scoring ranges from 0 (no oedema) to 4 (severe oedema [raised more than 1 millimeter and extending beyond area of exposure]. The total Draize score ranges from 0 to 8.|Day 1, Day 190|Participants enrolled in the study who had a baseline on MTE08 (Day 1) and a measurement at MTE09 endpoint (Day 190).||units on a scale||Standard Deviation|Mean
788439|NCT00857506|Secondary|Correlation of Change in ADAS-Cog and SUVR|Correlation between change from baseline to 36 month ADAS-Cog score and baseline global average SUVR by diagnostic group is provided below. ADAS-Cog scores (range 0-70) indicate performance on a series of 11 cognitive tasks where 0 indicates the highest level of cognitive performance and 70 indicates the lowest level of cognitive performance. Change in ADAS-Cog scores were calculated by subtracting the baseline score from the 36 month score (LOCF). A change in ADAS-Cog greater than 0 indicates a deterioration in cognitive performance whereas a change in ADAS-Cog less than 0 indicates improved cognitive performance. Standard Uptake Value Ratio (SUVR) is the ratio of tracer uptake in the cortex and cerebellum. SUVR values higher than 1 indicate greater amyloid burden in the cortex as compared to the cerebellum whereas scores less than 1 indicate the opposite.|Baseline and 36 months|||Pearson Correlation Coefficient|||Number
788440|NCT00857506|Secondary|Covariate Adjusted Psychometric Score Change|Change from baseline by diagnostic group in covariate-adjusted psychometric assessment scores at month 36 (LOCF). Assessments included Digit Symbol Substitution (DSS), Clinical Dementia Rating Sum of Boxes (CDR-SOB), Mini-Mental State Examination (MMSE), Wechsler Logical Memory Scale (WLMS) delayed and immediate recall, Category Verbal Fluency (CVF) animals and vegetables, Alzheimer's Disease Clinical Studies Consortium Activities of Daily Living (ADCS ADL) and Geriatric Depression Scale (GDS). The ranges for these scales are as follows: DSS (0-93), CDR-SOB (0-18), MMSE (0-30), WLMS delayed and immediate recall (0-25), CVF animals and vegetables (0-total number of relevant items named in 60 seconds), ADCS ADL (0-78) and GDS (0-15). For all scales except CDR-SOB and GDS a higher score indicates greater cognitive function. For CDR-SOB and GDS a higher score indicates increased dementia or depression, respectively.|Baseline and 36 months|Brain amyloid status was determined by baseline florbetapir F 18 PET scans performed in study 18F-AV-45-A05 (NCT00702143).||Scores on a scale||Standard Error|Mean
788441|NCT00857506|Secondary|Cognitive Decline in CN and AD Subjects|The key secondary analyses compared the number of Aβ+ and Aβ- subjects in the CN and AD populations with clinically significant deterioration in ADAS-Cog (≥4) and CDR global score (≥0.5). ADAS-Cog scores (range 0-70) indicate performance on a series of cognitive tasks where 0 indicates the highest level of cognitive performance and 70 indicates the lowest level of cognitive performance. CDR scores (range 0-3) quantify the severity of the symptoms of dementia where 0 indicates no cognitive impairment and 3 indicates severe dementia. Changes in ADAS-Cog and CDR scores were calculated by subtracting the baseline score from the 36 month score (LOCF).|Baseline and 36 months|Brain amyloid status was determined by baseline florbetapir F 18 PET scans performed in study 18F-AV-45-A05 (NCT00702143).||Participants|||Number
788451|NCT00857584|Secondary|Number of Patients With Remission at Week 8.|"Number of patients who achieved remission at week 8, where remission is defined as Montgomery Asberg Depression Rating Scale (MADRS) total score ≤ 10.
MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms."|week 8|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology||Participants|||Number
788442|NCT00857506|Secondary|Change in ADAS-Cog in CN and AD Subjects|This analysis compared the magnitude of change from baseline in ADAS cognitive subscale (ADAS-Cog) scores between Aβ+ and Aβ- subjects in the CN and AD populations at 36 months adjusting for baseline test score and age at informed consent. ADAS-Cog scores (range 0-70) indicate performance on a series of 11 cognitive tasks where 0 indicates the highest level of cognitive performance and 70 indicates the lowest level of cognitive performance. Change in ADAS-Cog scores were calculated by subtracting the baseline score from the 36 month score (LOCF). A change in ADAS-Cog greater than 0 indicates a deterioration in cognitive performance whereas a change in ADAS-Cog less than 0 indicates improved cognitive performance.|Baseline and 36 months|Brain amyloid status was determined by baseline florbetapir F 18 PET scans performed in study 18F-AV-45-A05 (NCT00702143).||Scores on a scale||Standard Error|Mean
788443|NCT00857506|Secondary|Cognitive Decline in MCI Subjects|The key secondary analyses compared the number of Aβ+ and Aβ- subjects in the MCI population with clinically significant deterioration in ADAS-Cog (≥4) and Clinical Dementia Rating (CDR) global score (≥0.5) and conversion in diagnosis from MCI at baseline to AD or Cognitively Normal (CN) at 36 months. ADAS-Cog scores (range 0-70) indicate performance on a series of 11 cognitive tasks where 0 indicates the highest level of cognitive performance and 70 indicates the lowest level of cognitive performance. CDR scores (range 0-3) quantify the severity of the symptoms of dementia where 0 indicates no cognitive impairment and 3 indicates severe dementia. Changes in ADAS-Cog and CDR scores were calculated by subtracting the baseline score from the 36 month score (LOCF).|Baseline and 36 months|Brain amyloid status was determined by baseline florbetapir F 18 PET scans performed in study 18F-AV-45-A05 (NCT00702143).||Participants|||Number
788444|NCT00857506|Primary|Change in ADAS-Cog for MCI Subjects|The primary analysis was the comparison in the magnitude of change from baseline in Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-Cog) between Aβ+ and Aβ- subjects in the Mild Cognitive Impairment (MCI) population at 36 months adjusting for baseline test score and age at informed consent. ADAS-Cog scores (range 0-70) indicate performance on a series of 11 cognitive tasks where 0 indicates the highest level of cognitive performance and 70 indicates the lowest level of cognitive performance. Change in ADAS-Cog scores were calculated by subtracting the baseline score from the 36 month score (last observation carried forward [LOCF]). A change in ADAS-Cog greater than 0 indicates a deterioration in cognitive performance whereas a change in ADAS-Cog less than 0 indicates improved cognitive performance.|Baseline and 36 months|Brain amyloid status was determined by baseline florbetapir F 18 PET scans performed in study 18F-AV-45-A05 (NCT00702143).||Scores on a scale||Standard Error|Mean
788445|NCT00857532|Secondary|Correlation of Florbetapir SUVR With CSF Biomarker Values|Correlation between amyloid burden (florbetapir SUVR) and cerebrospinal fluid (CSF) biomarker values (amyloid beta, tau and phospho-tau) was determined using Spearman's rank order correlation in a subset of subjects undergoing CSF analysis where SUVR was the dependent variable and CSF biomarker values were the independent variables.|50-60 min after injection|Participants were a subset of all subjects enrolled in this study who were also part of an ongoing study looking at the usefulness of CSF biomarkers.||Correlation Coefficient|||Number
788446|NCT00857532|Secondary|Correlation Between Global Amyloid Burden and Clinical Measures of Cognitive Decline.|Correlation between amyloid burden (global florbetapir SUVR) and cognitive decline (DRS-2 score) was determined using Spearman's rank order correlation method where SUVR was the dependent variable and the DRS-2 score was the independent variable. This analysis was performed for total DRS-2 score and the five DRS-2 subscale scores. The subscales (score range) are: Attention (0-37), Initiation/Perseveration (0-37), Construction (0-6), Conceptualization (0-39) and Memory (0-25). The total DRS-2 score is the sum of the subscale scores and ranges from 0-144. Higher DRS-2 scores indicate greater cognitive function.|50-60 min after injection|All subjects who were enrolled in the study and received florbetapir scans.||Correlation Coefficient|||Number
788447|NCT00857532|Primary|Mean Cortical Amyloid Burden|Standardized uptake value ratios (SUVR) were calculated and compared between subjects with PD and controls. Subjects with Parkinson's Disease (PD) were stratified into one of three groups based on performance on the age and education adjusted Mattis Dementia Rating Scale (DRS-2). The age and education adjusted DRS-2 ranges from 0 (lowest cognitive function) to 20 (highest cognitive function). SUVR is the ratio of tracer uptake in predefined cortical regions, relative to uptake in the whole cerebellum. SUVR values higher than 1 indicate greater amyloid burden in the predefined cortical regions as compared to cerebellum whereas scores less than 1 indicate the opposite. This outcome measure only reports data from the subjects analyzed in this study, the data from normal controls was obtained from a pre-existing database and is not reported here.|50-60 min after injection|All subjects who were enrolled in the study and received florbetapir scans.||SUVR||Standard Deviation|Mean
788448|NCT00857545|Secondary|Overall Survival|Overall survival is defined as the duration of time from study entry to time of death due to any cause or the date of last contact.|From study entry to death or last contact, up to 5 years of follow-up.|Enrolled and randomized participants. The upper limit of the 95% confidence interval for OS median in arm 1 is not available because the data is not mature enough for estimation at the time of this report.||Months||95% Confidence Interval|Median
788449|NCT00857545|Secondary|Incidence of Adverse Effects (Grade 3 or Higher) During Treatment Period|Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v4.0.|During treatment period and up to 30 days after stopping the study treatment; up to 83 weeks.|Enrolled and randomized and treated Patients. Grade 3 or worse adverse events for gastrointestinal disorders were significantly associated with treatment arm at significant level of 0.05 by two-sided Fisher’s exact test. The reporting arm 2 had higher proportion of patients with reported grade 3 or worse adverse events.||participants|||Number
788450|NCT00857545|Primary|Progression-free Survival (PFS)|Progression-free survival is the period of time from the date of randomization to the date of first clinical, biochemical, or radiological evidence of progression, death due to any cause or date of last contact, whichever occurs first. Progression is defined as increasing clinical, radiological or histological evidence of disease. Patients with progressing disease based on clinical or histologic basis (ie. biopsy) must also have CT scan of the abdomen and pelvis performed.|Every 3 month until 2 years from start of treatment, then every 6 months for 3 years; then annually if patient remains in remission.|Enrolled and randomized participants. 95% two-sided confidence interval||Months||95% Confidence Interval|Median
788489|NCT00857818|Primary|Mean Baseline Fasting Non-HDL Levels||At baseline (Day 1)|All randomized patients who took at least 1 dose of study medication during the treatment period.||mg/dL||Standard Error|Mean
788452|NCT00857584|Secondary|Number of Patients With Remission at Week 4.|"Number of patients who achieved remission at week 4, where remission is defined as Montgomery Asberg Depression Rating Scale (MADRS) total score ≤ 10.
MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms."|week 4|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.||Participants|||Number
788453|NCT00857584|Secondary|Number of Patients With Remission at Week 2.|"Number of patients who achieved remission at week 2, where remission is defined as Montgomery Asberg Depression Rating Scale (MADRS) total score ≤ 10.
MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms."|week 2|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.||Participants|||Number
788454|NCT00857584|Secondary|Number of Patients With Remission at Week 1.|"Number of patients who achieved remission at week 1, where remission is defined as Montgomery Asberg Depression Rating Scale (MADRS) total score ≤ 10.
MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms."|week 1|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.||Participants|||Number
788455|NCT00857584|Secondary|Number of Patients With Response at Week 8.|"Number of patients responded to the treatment at week 8, where response is defined as ≥ 50% reduction in the Montgomery Asberg Depression Rating Scale (MADRS) total score from baseline to week 8.
MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms."|week 8|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.||Participants|||Number
788456|NCT00857584|Secondary|Number of Patients With Response at Week 4.|"Number of patients responded to the treatment at week 4, where response is defined as ≥ 50% reduction in the Montgomery Asberg Depression Rating Scale (MADRS) total score from baseline to week 4.
MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms."|week 4|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.||Participants|||Number
788457|NCT00857584|Secondary|Number of Patients With Response at Week 2|"Number of patients responded to the treatment at week 2, where response is defined as ≥ 50% reduction in the Montgomery Asberg Depression Rating Scale (MADRS) total score from baseline to week 2.
MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms."|week 2|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.||Participants|||Number
788458|NCT00857584|Secondary|Number of Patients Response at Week 1|"Number of patients responded to the treatment at week 1, where response is defined as ≥ 50% reduction in the Montgomery Asberg Depression Rating Scale (MADRS) total score from baseline to week 1.
MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms."|week 1|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.||Participants|||Number
788459|NCT00857584|Secondary|The Mean Change From Baseline to Week 8 in the Hamilton Anxiety Rating Scale (HARS) Total Score|HARS assesses severity of anxiety symptoms. It ranges from a minimum of 0 to a maximum of 56 (higher scores indicating a greater severity of anxiety symptoms)|baseline, week 8|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.||score on a scale||95% Confidence Interval|Mean
788460|NCT00857584|Secondary|The Mean Change From Baseline to Week 4 in the Hamilton Anxiety Rating Scale (HARS) Total Score|HARS assesses severity of anxiety symptoms. It ranges from a minimum of 0 to a maximum of 56 (higher scores indicating a greater severity of anxiety symptoms)|baseline, week 4|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.||score on a scale||95% Confidence Interval|Mean
788461|NCT00857584|Secondary|The Mean Change From Baseline to Week 8 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score|CGI-BP-M assesses severity of clinical status. It ranges from a minimum of 1 to a maximum of 7 (higher scores indicating a greater clinical severity)|baseline, week 8|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.||score on a scale||95% Confidence Interval|Mean
788462|NCT00857584|Secondary|The Mean Change From Baseline to Week 4 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score|CGI-BP-M assesses severity of clinical status. It ranges from a minimum of 1 to a maximum of 7 ( higher scores indicating a greater clinical severity)|baseline, week 4|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.||score on a scale||95% Confidence Interval|Mean
788490|NCT00857818|Secondary|Mean Changes in Serum Prolactin Levels From Baseline||Baseline to Weeks 4, 8. and 16|Due to low enrollment, the study was terminated early. This endpoint was not analyzed because there were insufficient data to draw meaningful conclusions.|||||
788463|NCT00857584|Secondary|The Mean Change From Baseline to Week 2 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score|CGI-BP-M assesses severity of clinical status. It ranges from a minimum of 1 to a maximum of 7 ( higher scores indicating a greater clinical severity)|baseline, week 2|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.||score on a scale||95% Confidence Interval|Mean
788464|NCT00857584|Secondary|The Mean Change From Baseline to Week 1 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score|CGI-BP-M assesses severity of clinical status. It ranges from a minimum of 1 to a maximum of 7 ( higher scores indicating a greater clinical severity)|baseline, week 1|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology||score on a scale||95% Confidence Interval|Mean
788465|NCT00857584|Secondary|The Mean Change From Baseline to Week 8 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score|MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms)|baseline. week 8|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.||score on a scale||95% Confidence Interval|Mean
788466|NCT00857584|Secondary|The Mean Change From Baseline to Week 4 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score|MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms)|baseline, week 4|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.||score on a scale||95% Confidence Interval|Mean
788467|NCT00857584|Secondary|The Mean Change From Baseline to Week 1 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score|MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms)|baseline, week 1|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.||score on a scale||95% Confidence Interval|Mean
788468|NCT00857584|Primary|The Mean Change From Baseline to Week 2 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score|MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms)|baseline, week 2|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology. Safety data were analyzed for patients who received at least one dose of study medication.||score on a scale||95% Confidence Interval|Mean
788469|NCT00857623|Secondary|Change in Brief Pain Inventory-Short Form (BPI-SF) Pain Interference From Baseline to Day 28.|Change from baseline (measured prior to randomization) to Day 28 was calculated for pain interference (mean of 7 interference items). Each interference item is recorded on a Numerical Rating Scale (NRS 0-10), where 0= No interference and 10= Interferes completely.|From baseline to 28 days|Per Protocol population (PP)||Scores on a scale||Standard Error|Least Squares Mean
788470|NCT00857623|Secondary|Change in Brief Pain Inventory-Short Form (BPI-SF) Pain Severity From Baseline to Day 28.|Change from baseline (measured prior to randomization) to Day 28 was calculated for the pain severity (mean of 4 intensity items). Each intensity item is recorded on a Numerical rating Scale (NRS) 0-10, where 0=No pain and 10= The worst pain.|From baseline to day 28..|Per Protocol population (PP)||Scores on a scale||Standard Error|Least Squares Mean
788471|NCT00857623|Secondary|Change in McGill Pain Questionnaire Short Form (MPQ-SF) Affective Index From Baseline to Day 28.|"Affective index= sum of the intensity scale values of the words chosen for the descriptors 12-15 in the questionnaire. Range of scores for the affective index=0-12 (higher score represents a worse condition).
Change from baseline (measured prior to randomization) to Day 28 was calculated."|From baseline to day 28.|Per Protocol population (PP)||Scores on a scale||Standard Error|Least Squares Mean
788472|NCT00857623|Secondary|Change in McGill Pain Questionnaire Short Form (MPQ-SF) Sensory Index From Baseline to Day 28.|"Sensory index= sum of the intensity scale values of the words chosen for the descriptors 1-11 in the questionnaire. Range of scores for the sensory index= 0-33 (higher score represents a worse condition).
Change from baseline (measured prior to randomization) to Day 28 was calculated."|From baseline to day 28.|Per Protocol population (PP)||Scores on a scale||Standard Error|Least Squares Mean
788473|NCT00857623|Secondary|Number of Patients With Patient Global Impression of Change (PGIC) Score of at Least “Much Improved” at Day 28.|"Patient Global Impression of Change (PGIC) scale ranges from 1-7, where 1= Very much improved and 7= Very much worse.
Responder= Patient with a response of much improved or very much improved Responder rate= (no. of responders/total no. of patients)*100"|28 days|Per Protocol population (PP)||Participants|||Number
788474|NCT00857623|Secondary|Number of Patients With >=50% Reduction From Baseline in Numerical Rating Scale (NRS) Pain Intensity Score at Day 28|Pain intensity score reduction= (change from baseline D28/baseline)*100 Responder=pain intensity score reduction ≥50% (Yes/No)? Responder rate= (no. of responders/total no. of patients)*100|28 days|Per Protocol population (PP)||Participants|||Number
788475|NCT00857623|Secondary|Number of Patients With >=30% Reduction From Baseline in Numerical Rating Scale (NRS) Pain Intensity Score at Day 28|Pain intensity score reduction=(change from baseline at D28/baseline)*100 Responder= pain intensity score reduction ≥30% (yes/no)? Responder rate= (no. of responders/total no. of patients)*100|28 days|Per Protocol population (PP)||Participants|||Number
788476|NCT00857623|Secondary|Daily Numerical Rating Scale (NRS) Pain Scores and Change From Baseline Over Time to Day 28.|Mean pain intensity per day (mean of morning and evening NRS values) and change from baseline were calculated for each study day. Baseline value= mean pain intensity for the 5-day baseline period. NRS scale (0- 10) where 0= No pain and 10= Worst pain imaginable.|From baseline to 28 days|Per Protocol population (PP)||Scores on a scale||Standard Deviation|Mean
788477|NCT00857623|Primary|Change in Mean Numerical Rating Scale (NRS) Score From Baseline to Last 5 Days of Treatment|"Change of mean pain intensity from 5-day baseline to the last 5 days of treatment, measured twice daily with NRS (12 hours recall).
Mean pain intensity for 5-day baseline period (evening Day -6 to moning Day-1) and mean pain intensity for last 5 days on treatment (ie, last dose day and the 4 preceding calendar days) was calculated based on the numerical rating scale (NRS)(0-10). 0=No pain, 10=Worst pain imaginable."|From baseline to day 28|Per Protocol population (PP)||Scores on a scale||Standard Error|Least Squares Mean
788478|NCT00857649|Secondary|Efficacy of Memantine on Functioning Using CMAI - Long Form Total Score.|"Change from Baseline on the Cohen-Mansfield Agitation Inventory (CMAI) - Long Form total score.
CMAI - Long Form looks specifically at agitated behaviour in patients with cognitive impairment. It is a seven-point rating scale assessing the frequency of up to 29 agitated behaviours, ranging from 1 = Never to 7 = Several times an hour. Rating is based on responses obtained from interviews with the caregiver. The total score ranges from 29 to 203, with a higher score reflecting more frequent behavioural disturbances."|Baseline to Week 24|FAS; OC||Scores on a scale||Standard Error|Mean
788479|NCT00857649|Secondary|Efficacy of Memantine on Functioning Using ADCS-ADL - 19 Items Total Score.|"Change from Baseline on the Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) 19-item version total score.
ADCS-ADL- 19 items version for moderate to severe AD will measure patient's functioning. This battery of ADL questions is used here to measure the functional capabilities of patients with dementia. The inventory is done by interviewing a person in close contact with the patient and covers the most usual and consistent performance of the patient over the preceding 4 weeks. Total score is from 0 to 54. The higher score, the lower impairment."|Baseline to Week 24|FAS; OC||Scores on a scale||Standard Error|Mean
788480|NCT00857649|Secondary|Efficacy of Memantine on Global Condition Using CIBIC-plus.|"Clinician's Interview-Based Impression of Change-Plus Version (CIBIC-plus). Improvement evaluated with reference to Baseline.
CIBIC-plus is a global rating that is derived through an independent, comprehensive interview with the patient and caregiver by a rater who is barred from knowledge of all other psychometric test scores conducted as part of this protocol as well as from reported safety data. The rating is made on a 7-point scale ranging from 1 = marked improvement to 7 = marked worsening. A score of 4 indicates no change."|Baseline to Week 24|FAS; Observed Cases (OC).||Scores on a scale||Standard Error|Mean
788481|NCT00857649|Primary|Efficacy of Memantine on Cognition in Outpatients With Moderate to Severe Dementia of the Alzheimer's Type Using the SIB Total Score.|"Change from Baseline in Severe Impairment Battery (SIB) total score.
SIB is a validated scale used to assess cognitive function in patients with moderate to severe dementia. Items are single words or one-step commands combined with gestures. Nine domains are assessed, and the total score is between 0 and 100. A lower total score reflects the loss of cognitive function."|Baseline to Week 24|FAS; LOCF||Scores on a scale||Standard Error|Mean
788482|NCT00857649|Primary|Efficacy of Memantine on Behavioural Symptoms in Outpatients With Moderate to Severe Dementia of the Alzheimer's Type Using the NPI - 12 Items Version Total Score.|"Change from Baseline in Neuropsychiatric Inventory (NPI) total score.
NPI is a validated scale that assesses behavioural disturbances in patients with dementia. The 12 item version consists of 10 behavioural and 2 neurovegetative areas. It provides both a total score as well as scores for a number of sub-scales. The frequency, severity and caregiver distress for each domain are measured. The NPI is based upon responses obtained from the caregiver. The total score is from 0 to 144. A higher score reflects more frequency and severity of the disturbances."|Baseline to Week 24|"Full-analysis Set (FAS) – all randomised patients on current treatment with an acetylcholinesterase inhibitor (AChEI) who took at least one dose of investigational medicinal product (IMP) and had at least one post-baseline assessment on both co-primary efficacy variables.
Last Observation Carried Forward (LOCF)."||Scores on a scale||Standard Error|Mean
788483|NCT00857714|Secondary|Number of Patients With Toxicity Associated With Short Therapy With Lapatinib.|Number of patients with toxicity associated with short therapy with lapatinib will be reported.|Up to 60 days|||participants|||Number
788484|NCT00857714|Primary|Number of Patients Where Gene Signature Was Obtained.|Number of patients where gene signature was obtained. This was used to identify gene signature that denotes effect of lapatinib therapy in breast cancer cell lines and to assess effect of lapatinib therapy in patients with ductal carinoma in situ of the breast using the gene signature developed as a surrogate marker.|Up to 60 days|||participants|||Number
788485|NCT00857766|Secondary|Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at the 12-Week Endpoint|FEV1 is a measure of air flow via spirometry. Change from Baseline was calculated as the Endpoint value minus the Baseline Value.|Baseline and the 12-Week Endpoint (up to Week 12)|ITT Population. The number analyzed at baseline is different from that at the 12-week endpoint due to participant withdrawal. Data are missing for some participants in the ITT Population.||milliliters||Standard Error|Mean
788486|NCT00857766|Secondary|Mean Change From Baseline in Augmentation Index (AIx) at the 12-Week Endpoint|AIx is a surrogate measure of peripheral (not aortic) arterial resistance and is measured by analysis of the pulse wave at the radial artery. AIx = ([delta P/Pulse Pressure] x 100); delta P is defined by a notch near the peak of the pulse wave. Change from Baseline was calculated as the Endpoint value minus the Baseline Value.|Baseline and the 12-Week Endpoint (up to Week 12)|ITT Population. The number analyzed at baseline is different from that at the 12-week endpoint due to participant withdrawal. Data are missing for some participants in the ITT Population.||% of total height of peak pulse pressure||Standard Error|Mean
788487|NCT00857766|Primary|Mean Change From Baseline in Aortic Pulse Wave Velocity (aPWV) at the 12-Week Endpoint|The 12-week Endpoint is defined as the last scheduled measurement of PWV during the 12-week double-blind treatment period (from Visits 3-5; Weeks 4, 8, and 12, respectively), and Baseline is defined as the PWV measure from Visit 2 (Randomization). Change from Baseline was calculated as the Endpoint value minus the Baseline Value. PWV is used as a measure of arterial stiffness, which is a measure of the cushioning functioning of major vessels like the aorta. The velocity of the PW along an artery is dependent on the stiffness of that artery.|Baseline and the 12-Week Endpoint (up to Week 12)|Intent-to-Treat (ITT) Population: all participants who were randomized to study drug. The number analyzed at baseline is different from that at the 12-week endpoint due to participant withdrawal. Data are missing for some participants in the ITT Population.||meters per second (m/s)||Standard Error|Mean
788488|NCT00857792|Primary|Ability to Detect Stress-induced Myocardial Perfusion Abnormalities by Analysis of MDCT Images Confirmed by Coronary Angiography and/or SPECT.||3 months|||% accurately detected perfusion defects|Participants||Number
788493|NCT00857818|Secondary|Mean Change From Baseline in Impact of Weight on Quality of Life (IWQoL-Lite) Scores|The IWQoL-Lite is a 31-item self-report survey that assesses the impact of weight on quality of life (QoL) in obese patients. Total score=the sum of scores(ranging from 1-5 for each item) for all 31 items. The sum is then rescaled to a 0-100 scoring, with 0 representing the poorest and 100 the best QoL. The survey also assesses improvements in QoL that occur with weight losses of 5% or greater and deteriorations in QoL with weight gain of 5% or greater. A change of 7.8 to 12.0 points from baseline=meaningful improvement. A change of -4.5 to -7.6 points from baseline=meaningful deterioration.|Baseline to Weeks 4, 8, and 16|Due to low enrollment, the study was terminated early. This endpoint was not analyzed because there were insufficient data to draw meaningful conclusions.|||||
788494|NCT00857818|Secondary|Number of Participants With Potentially Clinically Relevant Changes From Baseline in Blood Pressure, Heart Rate, Hemoglobin Levels, White Blood Cell Count, Differential Count, and Absolute Platelet Count|Any value falling outside of the normal range will be flagged for the attention of the investigator at the site. The investigator will indicate whether or not a flagged value is of clinical significance.|Baseline and Weeks 4, 8, and 16|Due to low enrollment, this study was terminated early, and these data were not summarized.|||||
788495|NCT00857818|Secondary|Mean Changes From Baseline in Clinical Global Impression-Severity (CGI-S) Scale|The CGI-S scale is a 7-point scale that requires the clinician to rate the severity of a patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; or 7=extremely ill.|Baseline and Weeks 4, 8, and 16|Due to low enrollment, the study was terminated early. This endpoint was not analyzed because there were insufficient data to draw meaningful conclusions.|||||
788496|NCT00857818|Secondary|Percent of Participants Showing a Decrease or Increase in Body Weight of 7% or Greater From Baseline||Baseline and Weeks 4, 8, and 16|Due to low enrollment, the study was terminated early. This endpoint was not analyzed because there were insufficient data to draw meaningful conclusions.|||||
788497|NCT00857818|Secondary|Mean Changes From Baseline in Fasting Glucose Levels||Baseline to Week 16|Due to low enrollment, the study was terminated early. This endpoint was not analyzed because there were insufficient data to draw meaningful conclusions.|||||
788498|NCT00857818|Secondary|Mean Percent Changes From Baseline in Fasting Triglyceride and Total, High-Density Lipoprotein, and Low-Density Lipoprotein Cholesterol Levels||Baseline to Week 16|Due to low enrollment, the study was terminated early. This endpoint was not analyzed because there were insufficient data to draw meaningful conclusions.|||||
788499|NCT00857818|Secondary|Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and 1 or More AEs|AE=any new untoward medical event or worsening of a preexisting medical condition that may or may not be causally related to treatment. SAE=any untoward medical occurrence that at any dose results in death; is life-threatening, a congenital anomaly/birth defect, or an important medical event; requires or prolongs inpatient hospitalization, or results in persistent or significant incapacity or drug dependency or abuse.|Baseline to Week 16, continuously|All randomized subjects who took at least 1 dose of study medication during the treatment period.||Participants|||Number
788500|NCT00857818|Primary|Mean Percent Change From Baseline in Fasting Non-high Density Lipoprotein (Non-HDL) Cholesterol Levels|Based on Last Observation Carried Forward data. Non-HDL cholesterol is defined as the difference between total cholesterol and high-density lipoprotein (HDL) cholesterol levels. Fasting non-HDL cholesterol is defined as the measured fasting HDL cholesterol level subtracted from the measured fasting total cholesterol level.|Baseline to Weeks 4, 8, and 16|All randomized patients who took at least 1 dose of study medication during the treatment period. The Last Observation Carried Forward (LOCF) data set included data recorded at a given visit. If no observation was recorded at that visit, data was carried forward from the previous visit. .||Percentage of change||Standard Error|Mean
788501|NCT00857896|Secondary|Post-void Residual (PVR) Volume|Volume of urine remaining in the bladder immediately after urination.|Baseline, Week 4, and Week 8 post-dose|Safety Population: all participants who were known to have received study medication; Number of participants analyzed (N) = participants not performing clean intermittent bladder catheterization (CIC); n = participants not performing CIC at specified time point.||mL||Full Range|Median
788502|NCT00857896|Primary|Apparent Oral Clearance (CL/F)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated using non linear mixed effect modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Day 28 and Day 56|PK Concentration||L/hr||95% Confidence Interval|Mean
788503|NCT00857896|Primary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Day 28 and Day 56|Not analyzed due to the limited amount of data available.||hours||Standard Deviation|Mean
788504|NCT00857896|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||Day 28 and Day 56|Not analyzed due to the limited amount of data available.||hours||Standard Deviation|Mean
788505|NCT00857896|Primary|Maximum Observed Plasma Concentration (Cmax)||Day 28 and Day 56|Not analyzed due to the limited amount of data available.||micrograms per milliliter (mcg/mL)||Standard Deviation|Mean
788506|NCT00857896|Primary|Area Under the Plasma Drug Concentration Time Curve (AUC)|AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.|Day 28 and Day 56|Not analyzed due to the limited amount of data available.||mcg*h/mL||Standard Deviation|Mean
788507|NCT00857896|Primary|Apparent Volume of Distribution (VC/F)|The volume necessary to account for the total amount of drug in the body if it were present throughout the body at the same concentration found in the blood. Estimated using non linear mixed effect modeling.|Day 28 and Day 56|PK Concentration||Liters (L)||95% Confidence Interval|Mean
788508|NCT00857896|Primary|Absorption Rate Constant (Ka)||Day 28 and Day 56|Pharmacokinetic (PK) concentration population: randomized and treated participants who had at least 1 concentration during the study.||1/hour (hr)||95% Confidence Interval|Mean
788509|NCT00857948|Secondary|Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control).||Day 1 up to Day 28 post-application|Adverse events were assess in the Safety (Intent-to-treat) Population.||Participants|||Number
788510|NCT00857948|Secondary|Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control)|The severity of lice infestation was determined by visual checks of hair and scalp. Severity was rated as None: no live lice; Mild: 1 to 5 live lice; Moderate: 6 to 10 live lice; Severe: 11 to 20 live lice; or Very severe > 20 live lice.|Day 1 through Day 15 post-application|The level of lice infestation was assessed in the Intent-to-treat population. Any participant with live lice on or after Day 2 received an FDA approved head lice treatment and was classified as a treatment failure, imputed as such for remaining assessments.||Percent of participants|||Number
788511|NCT00857948|Secondary|Percentage of Index Participants Who Were Lice-Free at Different Time Points Post-treatment With Either Ivermectin or Placebo (Vehicle Control)|Live lice eradication was assessed on Days 1, 2, and 8 by visual checks of hair and scalp. Eradication was defined as cessation of motility (antennae and leg movement) in all lice.|Day 1 through Day 8 post-application|Live lice eradication was assessed in the Intent-to-treat Population. Any participant with live lice on or after Day 2 received an FDA approved head lice treatment and was classified as a treatment failure, imputed as such for remaining assessments.||Percent of participants|||Number
788512|NCT00857948|Primary|Percentage of Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 15 Post-treatment With Either Ivermectin or Placebo (Vehicle Control)|Live lice eradication was assessed by visual checks of hair and scalp on Days 1, 2 and 8 and by visual checks and counting both live and dead lice from rinse water on Day 15. Eradication was defined as cessation of motility (antennae and leg movement) in all lice.|Day 1 through Day 15 post-application|Live lice eradication was assessed in the Intent-to-treat Population. Any participant with live lice on or after Day 2 received an FDA approved head lice treatment and was classified as a treatment failure, imputed as such for remaining assessments.||Percent of participants|||Number
788513|NCT00857961|Secondary|Number of Participants With Adverse Events|A listing of adverse events is located in the Reported Adverse Events module.|Baseline through 7 days of each cycle of four treatments and follow-up (up to 38 days)|All participants received all four doses of testosterone-MD lotion.||participants|||Number
788514|NCT00857961|Primary|Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Area Under the Time Concentration Curve [AUC(0-24h)]|Area under the serum concentration versus time curve was calculated using the linear trapezoidal rule from time 0 to 24 hours on Day 7.|Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment|All participants received all four doses of testosterone-MD lotion. One study participant in the 30 mg of 2% testosterone MD-lotion was not included in any analyses dependent on testosterone/DHT concentration at 24 hours, such as AUC(0-24), Cavg, and comparison of the pre-dose with 24 hours post-dose, since a 24 hour blood sample was not collected.||h*ng/dL||Standard Deviation|Mean
788515|NCT00857961|Primary|Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Degree of Fluctuation (DF)|Degree of fluctuation in serum concentration calculated as ((Cmax-Cmin)/Cavg) x 100%.|Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment|All participants received all four doses of testosterone-MD lotion. One study participant in the 30 mg of 2% testosterone MD-lotion was not included in any analyses dependent on testosterone/DHT concentration at 24 hours, such as AUC(0-24), Cavg, and comparison of the pre-dose with 24 hours post-dose, since a 24 hour blood sample was not collected.||percent fluctuation in concentration||Standard Deviation|Mean
788516|NCT00857961|Primary|Pharmacokinetics of Free Testosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg)|Cmax is the maximum observed serum concentration of free testosterone during the 24 hour period on Day 7. Cmin is the minimum observed serum concentration during the 24 hour period on Day 7. Cavg(0-24) is the average serum concentration calculated during the 24 hour period on Day 7. Calculated as the AUC(0-24) divided by 24 hours.|Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment|All participants received all four doses of testosterone MD-lotion. One study participant in the 30 mg of 2% testosterone MD-lotion was not included in any analyses dependent on testosterone/DHT concentration at 24 hours, such as AUC(0-24), Cavg, and comparison of the pre-dose with 24 hours post-dose, since a 24 hour blood sample was not collected.||ng/dL||Standard Deviation|Mean
788517|NCT00857961|Primary|Pharmacokinetics of Dihydrotestosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg)|Cmax is the maximum observed serum concentration of dihydrotestosterone during the 24 hour period on Day 7. Cmin is the minimum observed serum concentration during the 24 hour period on Day 7. Cavg(0-24) is the average serum concentration calculated during the 24 hour period on Day 7. Calculated as the AUC(0-24) divided by 24 hours.|Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment|All participants received all four doses of testosterone-MD lotion. One study participant in the 30 mg of 2% testosterone MD-lotion was not included in any analyses dependent on testosterone/DHT concentration at 24 hours, such as AUC(0-24), Cavg, and comparison of the pre-dose with 24 hours post-dose, since a 24 hour blood sample was not collected.||ng/dL||Standard Deviation|Mean
788518|NCT00857961|Primary|Pharmacokinetics of Total Testosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg)|Cmax is the maximum observed serum concentration of total testosterone during the 24 hour period on Day 7. Cmin is the minimum observed serum concentration during the 24 hour period on Day 7. Cavg(0-24) is the average serum concentration calculated during the 24 hour period on Day 7. Calculated as the AUC(0-24) divided by 24 hours.|Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment|All participants received all four doses of testosterone-MD lotion. One study participant in the 30 mg of 2% testosterone MD-lotion was not included in any analyses dependent on testosterone/DHT concentration at 24 hours, such as AUC(0-24), Cavg, and comparison of the pre-dose with 24 hours post-dose, since a 24 hour blood sample was not collected.||ng/dL||Standard Deviation|Mean
788519|NCT00857961|Primary|Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Time of Maximal Concentration (Tmax)|Tmax is the time at which the maximum concentration (Cmax) was attained during the 24 hour period on Day 7.|Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment|All participants received all four doses of testosterone MD-lotion.||hours (h)||Full Range|Median
788520|NCT00858013|Secondary|HOMA-IR|insulin resistance marker HOMA-IR at 24 months|at 24 months|data of participants who finished 24 months of follow-up||mg/dL x mIU/L||Standard Deviation|Mean
788521|NCT00858013|Secondary|C-peptide|c-peptide(uU/mL) at 24 months|at 24 months|data of participants who finished 24 months of follow-up||uU/mL||Standard Deviation|Mean
788525|NCT00858143|Secondary|Adjusted Mean Dose of Somavert® Needed to Normalize the IGF-I Concentration in the ITT Population|Adjusted Mean Dose of Somavert® needed to normalize IGF-I concentration during study while simultaneously adjusting for potential confounding baseline variables measured prior to Somavert® therapy. Multiple linear regression model used to evaluate dose needed to normalise IGF-I concentration. Model included terms for IGF-I, growth hormone, age, weight and gender.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement; n=129).||milligram (mg)|||Number
788526|NCT00858143|Primary|Serious Adverse Events (SAE) and Adverse Events (AE)|Long term safety of Somavert in treatment of patients with acromegaly|Baseline up to 5 years|Safety Population; all patients who received at least one dose of Somavert® during the observation period.||participants|||Number
788527|NCT00858143|Secondary|Adjusted Mean Dose of Somavert® Needed to Normalize the IGF-I Concentration in the Safety Population|Adjusted Mean Dose of Somavert® needed to normalize IGF-I concentration during study while simultaneously adjusting for potential confounding baseline variables measured prior to Somavert® therapy. Multiple linear regression model used to evaluate dose needed to normalise IGF-I concentration. Model included terms for IGF-I, growth hormone, age, weight and gender.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|The safety evaluations were based on all 311 patients who received at least one dose of Somavert® (safety set).||milligram (mg)|||Number
788528|NCT00858143|Secondary|Change From Baseline in Ring Size|Change from baseline: ring size at observation minus ring size at baseline|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).||millimeters||Standard Deviation|Mean
788529|NCT00858143|Secondary|Change From Baseline for Systolic Blood Pressure (BP)|Change: systolic blood pressure at observation minus systolic blood pressure at baseline|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).||millimeters Mercury (mmHg)||Standard Deviation|Mean
788530|NCT00858143|Secondary|Change From Baseline for Diastolic Blood Pressure (BP)|Change: diastolic blood pressure at observation minus diastolic blood pressure at baseline|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).||millimeters per mercury (mmHg)||Standard Deviation|Mean
788531|NCT00858143|Secondary|Mean Change From Baseline for Body Weight|Change: body weight at observation minus body weight at baseline|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).||kilogram (kg)||Standard Deviation|Mean
788532|NCT00858143|Secondary|Change in Total PASQ Score Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)|Total PASQ score: total score calculated as sum of items 1-6; range is 0-48. Change from baseline calculated as total score at observation minus total score at baseline. PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)|ITT Population; subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). Data were available for 131 of the 270 ITT patients.||score on scale||95% Confidence Interval|Mean
788533|NCT00858143|Secondary|Change in General Physical Condition Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)|Change: score at observation minus score at baseline. General physical condition symptom in PASQ: disease-specific questionnaire based on the previous 6 questions which evaluated headache, excessive sweating, joint pain, fatigue, soft tissue swelling and numbness or tingling of limbs. Scoring 0-10 (0 = worst and 10 = best possible).|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)|ITT Population; subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). Data were available for 131 of the 270 ITT patients.||score on scale||95% Confidence Interval|Mean
788534|NCT00858143|Secondary|Change in Numbness or Tingling of Limbs Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)|Change: score at observation minus score at baseline. Numbness or tingling of limbs symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)|ITT Population; subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). Data were available for 130 of the 270 ITT patients.||score on scale||95% Confidence Interval|Mean
788535|NCT00858143|Secondary|Change in Soft Tissue Swelling Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)|Change: score at observation minus score at baseline. Soft tissue swelling symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)|ITT Population; subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). Data were available for 131 of the 270 ITT patients.||score on scale||95% Confidence Interval|Mean
788636|NCT00858689|Primary|ABC Irritability Subtest Score|ABC Irritability subtest score was used|8 weeks|completed 8 weeks of minocycline treatment||units on a scale||Standard Deviation|Mean
788536|NCT00858143|Secondary|Change in Fatigue Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)|Change: score at observation minus score at baseline. Fatigue symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)|ITT Population; subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). Data were available for 130 of the 270 ITT patients.||score on scale||95% Confidence Interval|Mean
788537|NCT00858143|Secondary|Change in Joint Pain Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)|Change: score at observation minus score at baseline. Joint pain symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)|ITT Population; subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). Data were available for 131 of the 270 ITT patients.||score on scale||95% Confidence Interval|Mean
788538|NCT00858143|Secondary|Change in Excessive Sweating Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)|Change: score at observation minus score at baseline. Excessive sweating symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)|ITT Population; subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). Data were available for 131 of the 270 ITT patients.||score on scale||95% Confidence Interval|Mean
788539|NCT00858143|Secondary|Change in Headache Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)|Change: score at observation minus score at baseline. Headache symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)|ITT Population; subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). Data were available for 131 of the 270 ITT patients.||score on scale||95% Confidence Interval|Mean
788540|NCT00858143|Secondary|Glucose Values Above Normal Range in Diabetic Patients (Fasting)|Number of Diabetic Patients (fasting) with Glucose Values Above Normal Range|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).||participants|||Number
788541|NCT00858143|Secondary|Glucose Values Within Normal Range in Diabetic Patients (Fasting)|Number of Diabetic Patients (fasting) with Glucose Values Within Normal Range|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).||participants|||Number
788542|NCT00858143|Secondary|Absolute Glucose Values in Diabetic Patients (Fasting)|Absolute Glucose Values in Patients with Diabetes (fasting)|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).||milligram per deciliter (mg/dl)||Standard Deviation|Mean
788543|NCT00858143|Secondary|Glucose Change From Baseline in Diabetic Patients (Fasting)|Change: glucose at observation minus glucose at baseline|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).||milligram per deciliter (mg/dl)||95% Confidence Interval|Mean
788544|NCT00858143|Secondary|HbA 1c Values Above Normal Range in Diabetic Patients|Number of Diabetic Patients with HbA 1c Values Above Normal Range|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).||participant|||Number
788545|NCT00858143|Secondary|HbA 1c Values Below Normal Range in Diabetic Patients|Number of Diabetic Patients with HbA 1c Values Below Normal Range|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).||participant|||Number
788546|NCT00858143|Secondary|HbA 1c Values Within Normal Range in Diabetic Patients|Number of Diabetic Patients with HbA 1c Values Within Normal Range.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).||participants|||Number
788547|NCT00858143|Secondary|Change From Baseline Hemoglobin A 1c (HbA 1c) in Diabetic Patients|Change: HbA 1c at observation minus HbA 1c at baseline.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).||percent (%)||95% Confidence Interval|Mean
788689|NCT00859131|Secondary|Incidence of Leukopenia, Defined as a Total White Blood Cell Count of Less Than 2,000 Cells/mm3||One year|||participants|||Number
788548|NCT00858143|Secondary|Absolute Values for Hemoglobin A 1c (HbA 1c) in Diabetic Patients|Absolute Values for Hemoglobin A 1c (HbA 1c) in Patients with Diabetes|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).||percent (%)||Standard Deviation|Mean
788549|NCT00858143|Secondary|Insulin-Like Growth Factor I (IGF-I) Values Above Normal Range in Diabetic Patients|Number of Diabetic Patients with Insulin-Like Growth Factor I (IGF-I) values Above Normal Range (local laboratory, different assay).|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).||participants|||Number
788550|NCT00858143|Secondary|Insulin-Like Growth Factor I (IGF-I) Values Within Normal Range in Diabetic Patients|Number of Diabetic Patients with Insulin-Like Growth Factor I (IGF-I) values Within Normal Range (local laboratory, different assay).|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).||participants|||Number
788551|NCT00858143|Secondary|Absolute Values Insulin-Like Growth Factor I (IGF-I) in Diabetic Patients|Absolute values Insulin-Like Growth Factor I (IGF-I) in Patients with Diabetes (local laboratory, different assay).|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).||micrograms per liter (ug/l)||Standard Deviation|Mean
788552|NCT00858143|Secondary|Change From Baseline Insulin-Like Growth Factor I (IGF-I) in Diabetic Patients|Change: IGF-I concentration at observation minus IGF-I concentration at baseline. (local laboratory, different assay).|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).||micrograms per liter (ug/l)||95% Confidence Interval|Mean
788553|NCT00858143|Secondary|Absolute Hemoglobin A 1c (HbA 1c) Values|Absolute value Hemoglobin A 1c (HbA 1c)|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).||percent (%)||Standard Deviation|Mean
788554|NCT00858143|Secondary|Absolute Glucose Values (2h oGTT)|Absolute Glucose values - 2 Hour Oral Glucose Tolerance Test (2h oGTT).|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).||milligram per deciliter (mg/dl)||Standard Deviation|Mean
788555|NCT00858143|Secondary|Absolute Glucose Values (Fasting)|Absolute Glucose values (fasting)|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).||milligram per deciliter (mg/dl)||Standard Deviation|Mean
788556|NCT00858143|Secondary|IGF-I Absolute Values|IGF-I absolute values (local laboratory, different assay).|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).||micrograms per liter (ug/l)||Standard Deviation|Mean
788557|NCT00858143|Secondary|Glucose (2 Hour Oral Glucose Tolerance Test (2h oGTT)) Values Above Normal Range|Number of participants with glucose values (2h oGTT) above normal range.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).||participants|||Number
788558|NCT00858143|Secondary|Glucose (2 Hour Oral Glucose Tolerance Test (2h oGTT)) Values Within Normal Range|Number of participants with glucose values (2h oGTT) within normal range.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).||participants|||Number
788559|NCT00858143|Secondary|Glucose Values Above Normal Range (Fasting)|Number of participants with glucose values above normal range (fasting).|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).||participants|||Number
788560|NCT00858143|Secondary|Glucose Values Below Normal Range (Fasting)|Number of participants with glucose values below normal range (fasting).|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).||participants|||Number
788690|NCT00859131|Secondary|Incidence of Post-transplant Malignancies, Including Post-transplant Lymphoproliferative Disease (PTLD) and Skin Cancers.||One year|||participants|||Number
789189|NCT00861692|Primary|All-cause Death||During and 30 days after argatroban treatment|||participants|||Number
788561|NCT00858143|Secondary|Glucose Values Within Normal Range (Fasting)|Number of participants who have glucose values within normal range (fasting).|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).||participants|||Number
788562|NCT00858143|Secondary|Change From Baseline Glucose <(2 Hour Oral Glucose Tolerance Test (2h oGTT)>|Change: glucose 2h oGTT at observation minus glucose 2h oGTT at baseline.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).||milligram per deciliter (mg/dl)||Standard Deviation|Mean
788563|NCT00858143|Secondary|Change From Baseline Glucose (Fasting)|Change: glucose at observation minus glucose at baseline.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).||milligram per deciliter (mg/dl)||Standard Deviation|Mean
788564|NCT00858143|Secondary|HbA 1c Values Above Normal Range|Number of participants with HbA 1c values above normal range.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).||participants|||Number
788565|NCT00858143|Secondary|HbA 1c Values Below Normal Range|Number of participants who have HbA 1c values below normal range.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5), 60 months (FUP 6)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).||participants|||Number
788566|NCT00858143|Secondary|HbA 1c Values Within Normal Range|Number of participants who have HbA 1c values within normal range.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).||participant|||Number
788567|NCT00858143|Secondary|Change From Baseline Hemoglobin A 1c (HbA 1c)|Change: HbA 1c at observation minus HbA 1c at baseline.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).||percent (%)||Standard Deviation|Mean
788568|NCT00858143|Secondary|IGF-I Values Above Normal Range|Number of participants who have IGF-I values above normal range (local laboratory, different assay).|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).||participant|||Number
788569|NCT00858143|Secondary|IGF-I Values Within Normal Range|Number of participants who have IGF-I values within normal range (local laboratory, different assay).|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).||participant|||Number
788570|NCT00858143|Secondary|Change From Baseline Insulin-like Growth Factor I (IGF-I)|Change: IGF-I concentration at observation minus IGF-I concentration at baseline (local laboratory, different assay).|Baseline, Follow-up 1 (FUP 1) at ~6 months , Follow-up 2 (FUP 2) at ~12 months, Follow-up 3 (FUP 3) at ~ 24 months, Follow-up 4 (FUP 4) at ~ 36 months, Follow-up 5 (FUP 5) at ~ 48 months, Follow-up 6 (FUP 6)at ~60 months|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).||micrograms per liter (ug/l)||Standard Deviation|Mean
788571|NCT00858208|Other Pre-specified|Change From Baseline to Final Visit in Intraocular Pressure (IOP) (Before and After Injection)|IOP was measured using either applanation or tonopen before intravitreal injection, reported as pre-dose and post-dose pressure. IOP valid range: 10-21 mmHg. Change: IOP at Visit X minus IOP at Baseline.|Baseline and Week 102 or ET|SAS; N=participants with evaluable data at baseline; n=participants with evaluable data at specified time point||millimeters of mercury (mmHg)|Participants|Standard Deviation|Mean
788572|NCT00858208|Other Pre-specified|Number of Participants Who Discontinued Treatment Prematurely or Changed Treatment During the Course of the Study|Participants with dose reduction or temporary discontinuation of treatment due to adverse events (AEs).|Baseline through Week 102|SAS||participants|||Number
788573|NCT00858208|Other Pre-specified|Number of Participants for Whom Indocyanine Green Angiography Was Used to Monitor the Course of AMD Treatment|Participant counts by type of diagnostic procedure (indocyanine green angiography) used to monitor AMD treatment.|Every 6 weeks up to Week 102|SAS||participants|||Number
788574|NCT00858208|Other Pre-specified|Number of Participants for Whom Optical Coherence Tomography Was Used to Monitor the Course of AMD Treatment|Participant counts by type of diagnostic procedure (optical coherence tomography) used to monitor AMD treatment.|Every 6 weeks up to Week 102|SAS||participants|||Number
788575|NCT00858208|Other Pre-specified|Number of Participants for Whom Fluorescein Angiography Was Used to Monitor the Course of AMD Treatment|Participant counts by type of diagnostic procedure (fluorescein angiography) used to monitor AMD treatment.|Every 6 weeks up to Week 102|SAS||participants|||Number
788691|NCT00859131|Secondary|Incidence of Post-transplant Infections, Including, But Not Limited to, CMV Infection and Disease, BK Infection and Nephropathy, Other Opportunistic Infections, Urinary Tract Infections, Pneumonia, and Sepsis||one year|||participants|||Number
788692|NCT00859131|Secondary|Graft Survival at One Year Post-transplant||One year|||participants|||Number
788576|NCT00858208|Other Pre-specified|Change From Baseline VA at the Final Visit by Previous Treatment of AMD|Participant population (by previous treatment of AMD) that benefited more from Pegaptanib treatment based on change from baseline VA at final visit. VA measured by previous AMD treatment (yes/no) using ETDRS chart at 4 meter distance, at 1 meter distance (if participant's VA was poor) or verifying if participant able only to count fingers, perceive hand motion, or light. VA expressed as logMAR could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in logMAR scale represents improvement in VA.|Baseline, Week 102 or ET|SAS subset of participants for who data was collected about previous AMD treatment (yes/no); n=number of participants with evaluable data at specified time point||scores on a scale|Participants|Standard Deviation|Mean
788577|NCT00858208|Other Pre-specified|Change From Baseline VA at the Final Visit by Age-related Macular Degeneration (AMD) Stage|Participant population (by AMD stage) that benefited more from Pegaptanib treatment based on change from baseline VA at final visit. VA measured by AMD stage (early lesion, late stage lesion, other) using ETDRS chart at 4 meter distance, at 1 meter distance (if participant's VA was poor) or verifying if participant able only to count fingers, perceive hand motion, or light. VA expressed as logMAR could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in logMAR scale represents improvement in VA.|Baseline, Week 102 or ET|SAS subset of participants with AMD; n=participants with evaluable data at specified time point and stage of AMD||logMAR|Participants|Standard Deviation|Mean
788578|NCT00858208|Other Pre-specified|Change From Baseline VA at Final Visit by Age Group|Participant population (by age group) that benefited more from Pegaptanib treatment based on change from baseline VA at final visit. VA measured by age group (51 to 64 years, greater than or equal to [>=] 65 years) using ETDRS chart at 4 meter distance, at 1 meter distance (if participant's VA was poor) or verifying if participant able only to count fingers, perceive hand motion, or light. VA expressed as logMAR could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in logMAR scale represents improvement in VA.|Baseline, Week 102 or ET|SAS;N=participants with evaluable data; n=participants with evaluable data at specified time point and age group||logMAR|Participants|Standard Deviation|Mean
788579|NCT00858208|Secondary|Change From Baseline NEI-VFQ-25 Sub-scale Scores at Final Visit|Participant-reported 25 item questionnaire. Responses to each question converted to 0-100 score. Questions grouped into 11 vision-targeted categories and 1 general heath category. Sub-scale score=mean score in a category. Range of sub-scale scores=0 to 100 where higher scores represent better functioning. Change: Sub-scale scores score at Visit X minus sub-scale score at Baseline, where higher scores represent better functioning.|Baseline, Week 102 or ET|SAS; N=participants with evaluable data; n=participants with evaluable data at specified time point and item in questionnaire||scores on a scale||Standard Deviation|Mean
788580|NCT00858208|Secondary|Change From Baseline NEI-VFQ-25 Overall Composite Score at Final Visit|Participant-reported 25 item questionnaire. Responses to each question converted to 0-100 score. Questions grouped into 11 vision-targeted categories and 1 general health category. Mean score calculated for each category. Overall composite score=mean of 11 vision-targeted sub categories. Range of composite score=0 to 100 where higher scores represent better functioning. Change: Composite score at Visit X minus composite Score at Baseline, where higher scores represent better functioning.|Baseline, Week 102 or ET|SAS; N=participants with evaluable data||scores on a scale||Standard Deviation|Mean
788581|NCT00858208|Secondary|Change From Baseline NEI-VFQ-25 Overall Composite Score at Each Visit|Participant-reported 25 item questionnaire. Responses to each question converted to 0-100 score. Questions grouped into 11 vision-targeted categories and 1 general health category. Mean score calculated for each category. Overall composite score=mean of 11 vision-targeted sub categories. Range of composite score=0 to 100 where higher scores represent better functioning. Change: Composite score at Visit X minus composite Score at Baseline, where higher scores represent better functioning.|Baseline, Month 6, 12, 18, and 24|SAS; N=participants with evaluable data; n=participants with evaluable data at specified time point||scores on a scale||Standard Deviation|Mean
788582|NCT00858208|Secondary|Change From Baseline VA at the Final Visit for Participants With Vascular Retinal Pigment Epithelial Detachment (RPED)|"VA measured using Early Treatment Diabetic Retinopathy Study (ETDRS), Snellen chart, or other methods verifying if the participant was able to count fingers, perceive hand motion, or light. VA expressed as the logarithm of the minimum angle of resolution (logMAR), and could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in the logMAR scale represents an improvement in VA. On the case report form, participants with RPED=those with the Pigment Epithelial Detachment (PED) present box ticked at Baseline Visit."|Baseline, Week 102 or ET|SAS subset of participants with RPED at baseline||logMAR|Participants|Standard Deviation|Mean
788583|NCT00858208|Secondary|Change From Baseline VA at Each Visit|VA measured using Early Treatment Diabetic Retinopathy Study (ETDRS), Snellen chart, or other methods verifying if the participant was able to count fingers, perceive hand motion, or light. VA expressed as the logarithm of the minimum angle of resolution (logMAR), and could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in the logMAR scale represents an improvement in VA.|Baseline, every 6 weeks up to Week 102|SAS; Number of participants analyzed (N)=participants with evaluable data; n=participants with evaluable data at specified time point||logMAR|Participants|Standard Deviation|Mean
788584|NCT00858208|Primary|Change From Baseline Visual Acuity (VA) at the Final Visit|VA measured using Early Treatment Diabetic Retinopathy Study (ETDRS), Snellen chart, or other methods verifying if the participant was able to count fingers, perceive hand motion, or light. VA expressed as the logarithm of the minimum angle of resolution (logMAR), and could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in the logMAR scale represents an improvement in VA.|Baseline, Week 102 or Early Termination (ET)|Safety Analysis Set (SAS) = Full Analysis Set (FAS): Enrolled participants who received at least 1 dose of Pegaptanib; Number of participants analyzed (N)=participants with evaluable data||logMAR|Participants|Standard Deviation|Mean
788585|NCT00858247|Secondary|Change in High-Sensitivity C-Reactive Protein After 12 Weeks of Vitamin D Supplementation|The high-sensitivity C-reactive protein test measures your risk for heart problems. <1.0 mg/L is lowest risk, 1.0-3.0 mg/L is average risk, and >3.0 mg/L is highest risk.|baseline, 12 weeks|One subject in the high-dose arm dropped out before the week 12 assessment, so the reporting population on the high dose arm was 23, not 24.||mg/L||Standard Deviation|Mean
788586|NCT00858247|Secondary|Change in Triglycerides After 12 Weeks of Vitamin D Supplementation|The current recommendation on fasting blood triglyceride levels: < 150 mg/dL is normal, >150 mg/dL is borderline high, and >200 mg/dL is high.|baseline, 12 weeks|One subject in the high-dose arm dropped out before the week 12 assessment, so the reporting population on the high dose arm was 23, not 24.||mg/dL||Standard Deviation|Mean
788587|NCT00858247|Secondary|Change in High Density Lipoprotein (HDL) Cholesterol After 12 Weeks of Vitamin D Supplementation|HDL (good) cholesterol protects against heart disease, so for HDL, higher numbers are better. A level less than 40 mg/dL is low and is considered a major risk factor because it increases your risk for developing heart disease. HDL levels of 60 mg/dL or more help to lower your risk for heart disease.|baseline, 12 weeks|One subject in the high-dose arm dropped out before the week 12 assessment, so the reporting population on the high dose arm was 23, not 24.||mg/dL||Standard Deviation|Mean
788588|NCT00858247|Secondary|Change in Low Density Lipoprotein (LDL) Cholesterol After 12 Weeks of Vitamin D Supplementation|LDL cholesterol is considered to be the main source of cholesterol buildup and blockage in the arteries. Less than 100 mg/dL is optimal, >130 mg/dL is borderline high, >160 mg/dL is high, >190 mg/dL is very high.|baseline, 12 weeks|One subject in the high-dose arm dropped out before the week 12 assessment, so the reporting population on the high dose arm was 23, not 24.||mg/dL||Standard Deviation|Mean
788589|NCT00858247|Secondary|Change in Total Cholesterol After 12 Weeks of Vitamin D Supplementation|Less than 200 mg/dL is desirable, >200 mg/dL is borderline high, >240 mg/dL is High|baseline, 12 weeks|One subject in the high-dose arm dropped out before the week 12 assessment, so the reporting population on the high dose arm was 23, not 24.||mg/dL||Standard Deviation|Mean
788590|NCT00858247|Primary|Change in Insulin Resistance After 12 Weeks of Vitamin D3 Supplementation|"Insulin resistance (IR) is a physiological condition in which cells fail to respond to the normal actions of the hormone insulin. The body produces insulin, but the cells in the body become resistant to insulin and are unable to use it as effectively, leading to hyperglycemia. Beta cells in the pancreas subsequently increase their production of insulin, further contributing to hyperinsulinemia.
From the fasting glucose and insulin measurements, insulin resistance was calculated by the homeostasis model assessment of insulin resistance (HOMA -IR) as: HOMA -IR = fasting insulin concentration (µU/mL) x fasting glucose concentration (mmol/L)/22.5. High HOMA-IR scores denote increased insulin resistance."|Baseline, 12 weeks|All subjects had blood drawn but some tests such as insulin could not be done in some cases due to sample issues. This lab test was calculated from other parameters and not drawn per se. If the values obtained did not allow a calculation of the lab test, then the results could not be reported.||HOMA score||Standard Deviation|Mean
788591|NCT00858390|Primary|Primary Outcome Measure is IL-6 Level|Plasma IL-6 level measured by ELISA. The 12+/-2 hour time frame is prior to organ explantation.|12+/-2 hours|||pg/ml||Standard Deviation|Mean
788592|NCT00858403|Secondary|Correlation Between Mutation and Inhibition and to Disease Control Rate and Response|To analyze Kras and epidermal growth factor receptor (EGFR) mutation and their correlation to the ERK pathway inhibition and to disease control rate and response.|1 year, 4 months|The low accrual of 7 participants prevented us from completing the planned analysis. Target accrual was 40.|||||
788593|NCT00858403|Secondary|Correlation Between Extent of Inhibition and Concentration of Dasatinib|We planned to explore whether the extent of inhibition of ERK, SRC and Akt phosphorylation in lung cancer cells exposed ex vivo to dasatinib will correlate with the drug concentration of dasatinib.|1 year, 4 months|The low accrual of 7 participants prevented us from completing the planned analysis. Target accrual was 40.|||||
788594|NCT00858403|Secondary|Number of Participant Progressors vs. Non-Progressors With Inhibition Response|We planned to assess whether the extent of inhibition of proto-oncogene tyrosine-protein kinase (SRC) and protein kinase B (Akt) phosphorylation in lung cancer cells exposed ex vivo and in vivo to dasatinib significantly differs between patients categorized as progressors or non-progressors through standard RECIST criteria.|1 year, 4 months|The low accrual of 7 participants prevented us from completing the planned analysis. Target accrual was 40.|||||
788595|NCT00858403|Secondary|Number of Participants With Serious Adverse Events (SAEs)|We evaluated toxicity of dasatinib in this patient population.|1 year, 4 months|||Participants|||Number
788596|NCT00858403|Secondary|Number of Participants With Progression Free Survival (PFS) at 6 Months|We planned to estimate the 6 month progression free survival rate of dasatinib in this patient population.|1 year, 4 months|We were able to assess 4 of the 7 participants at 6 months.||Participants|||Number
788597|NCT00858403|Secondary|Number of Participants With Response to Dasatinib|We planned to estimate the single agent response rate to dasatinib in this patient population|1 year, 4 months|The low accrual of 7 participants prevented us from completing the planned analysis. Target accrual was 40.|||||
788598|NCT00858403|Primary|Number of Participant Progressors vs. Non-progressors With Tumor Response|We planned to assess whether the extent of inhibition of extracellular signal-regulated protein kinase (ERK) phosphorylation in lung cancer cells exposed ex vivo to dasatinib significantly differed between patients categorized as progressors or non-progressors through standard Response Evaluation Criteria In Solid Tumors (RECIST)|1 year, 4 months|The low accrual of 7 participants prevented us from completing the planned analysis. Target accrual was 40.|||||
788599|NCT00858442|Secondary|Length of the Graft|Central length measurement graft between the start and the end of the compression|start and end compression|||centimeter|Participants|Inter-Quartile Range|Median
788600|NCT00858442|Secondary|Width of the Graft|Central width measurement graft between the start and the end of the compression|start and end compression|||centimeter|Participants|Inter-Quartile Range|Median
788601|NCT00858442|Primary|Median Time Between Surgery Date and Start Date Compression.|Participants were followed from the date of surgery and the date of onset of compression for a minimum of 13.5 days and a maximum of 27 days|day|A participant may have one, two or three areas grafted||day|Participants|Full Range|Median
788602|NCT00858468|Other Pre-specified|Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-vaccination With Fluzone® Vaccine.|Data presented for each of the three influenza vaccine virus antigens in the Fluzone® 2004-2005 pediatric formulation.|21 days post-vaccination 2|GMTs were assessed on the Per-Protocol Population||Titers||95% Confidence Interval|Geometric Mean
788693|NCT00859131|Secondary|Number of Patients Requiring Antilymphocyte Therapy for Acute Rejection.||One year|||Patients|||Number
788694|NCT00859131|Primary|Treatment Efficacy Will be Defined as the Number of Patients With Biopsy Proven Acute Rejection at One Year Post-transplant.||One year|||participants|||Number
788603|NCT00858468|Other Pre-specified|Percentage of Participants With a Pre-vaccination Serum Hemagglutination Inhibition Antibody Titer of ≤ 10 That Had a Titer of ≥ 40 Post-vaccination With Fluzone® (Seroconversion).|Seroconversion was defined as the percentage of participants with a pre-titer < 1:10 who demonstrated a ≥ 4-fold increases in titer from pre- to post-vaccination.|21 days post-vaccination 2|Seroconversion analysis was in all enrolled and vaccinated participants in the per-protocol immunogenicity population.||Percentage of participants|||Number
788604|NCT00858468|Other Pre-specified|Percentage of Participants With Serum Hemagglutination Inhibition Antibody Titer ≥ 40 Post-vaccination With Fluzone® (Seroprotection).|"Data presented for each of the three influenza vaccine virus antigens in the Fluzone® 2004-2005 pediatric formulation.
Seroprotection was defined as the percentage of participants with a reciprocal hemagglutination inhibition titers ≥ 40"|21 days post-vaccination 2|Seroprotection analysis was in all enrolled and vaccinated participants in the per-protocol immunogenicity population.||Percentage of participants|||Number
788605|NCT00858468|Primary|Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation.|Solicited local (injection site) reactions: Tenderness, erythema (redness), and swelling Solicited systemic reactions: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Loss of Appetite, and Irritability.|Day 0 to Day 7 post-vaccination|Safety analysis was on all enrolled and vaccinated subjects with available reaction data, intend-to-treat population||Percentage of participants|||Number
788610|NCT00858507|Primary|Receipt of Primary Care at the VA|The primary aim of this study was to conduct a randomized controlled trial of different interventions aimed at increasing rates of treatment engagement among a community sample of treatment-naive homeless veterans.|within 4 weeks of intervention|||participants|||Number
788611|NCT00858637|Secondary|Vital Signs, Adverse Events, and Laboratory Values||throughout study||||||
788612|NCT00858637|Secondary|Change in Phosphorus(P), Calcium(Ca), Calcium-phosphorus Ion Product(PxCa) and Parathyroid Hormone (PTH)||16 weeks and 20 weeks||||||
788613|NCT00858637|Secondary|Percent Change in Serum LDL-cholesterol Levels From Baseline to Week 16 (LOCF) (ITT1)|Percent Change from Baseline to Week 16 (LOCF)|week16 minus week0|ITT1 population included all subjects who received a randomisation number, took at least 1 dose of study medication and had at least 1 central serum LDL-C value after the start of study medication.||Percent Change of LDL-cholesterol||Standard Deviation|Mean
788614|NCT00858637|Primary|Percent Change in Serum LDL-cholesterol Levels From Week 16 to Week 20 (LOCF) (ITT2)|Percent Change from Week 16 to Week 20 (LOCF)|week20 minus week16|ITT2 population included all re-randomised subjects who completed 16 weeks in the active treatment groups (MCI-196 or simvastatin), received at least 1 dose of study medication in the Placebo-controlled withdrawal phase and had at least 1 central serum LDL-C value after Week 16.||Percent Change of LDL-cholesterol||Standard Deviation|Mean
788615|NCT00858689|Secondary|Vineland Adaptive Behaviour Scales (VABS)||1 year||||||
788616|NCT00858689|Secondary|Vineland Adaptive Behaviour Scales (VABS)||8 weeks||||||
788617|NCT00858689|Secondary|Non-Verbal Associative Learning Task (NVALT)||1 year||||||
788618|NCT00858689|Secondary|Non-Verbal Associative Learning Task (NVALT)||8 weeks||||||
788619|NCT00858689|Secondary|The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)||1 year||||||
788620|NCT00858689|Secondary|The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)||8 weeks||||||
788621|NCT00858689|Secondary|The Peabody Picture Vocabulary Test Third Edition (PPVT-III)||1 year||||||
788622|NCT00858689|Secondary|The Peabody Picture Vocabulary Test Third Edition (PPVT-III)||8 weeks||||||
788623|NCT00858689|Secondary|Stanford Binet 5 (SB5)||1 year||||||
788624|NCT00858689|Secondary|Clinical Global Impression Scale||1 year||||||
788625|NCT00858689|Secondary|Clinical Global Impression Scale||8 weeks||||||
788626|NCT00858689|Secondary|Parent Defined Target Symptoms Scale-Visual||1 year||||||
788627|NCT00858689|Secondary|Parent Defined Target Symptoms Scale-Visual||8 weeks||||||
788628|NCT00858689|Secondary|Vineland Adaptive Behaviour Scales (VABS)||Baseline||||||
788629|NCT00858689|Secondary|Non-Verbal Associative Learning Task (NVALT)||Baseline||||||
788630|NCT00858689|Secondary|The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)||Baseline||||||
788631|NCT00858689|Secondary|The Peabody Picture Vocabulary Test Third Edition (PPVT-III)||Baseline||||||
788632|NCT00858689|Secondary|Stanford Binet 5 (SB5)||Baseline||||||
788633|NCT00858689|Secondary|Clinical Global Impression Scale||Baseline||||||
788634|NCT00858689|Secondary|Parent Defined Target Symptoms Scale-Visual||Baseline||||||
788635|NCT00858689|Primary|ABC Irritability Subtest Score|ABC (Aberrant behavior checklist) Irritability subtest score was used|1 year||||||
788637|NCT00858689|Primary|Change From Baseline of ABC Irritability Subtest Score at 8 Weeks|The 15-item Irritability Scale includes questions about aggression, self-injury, tantrums, agitation, and unstable mood on a scale of 0 to 45 with higher scores indicating greater severity. This scale has been successfully used in previous medication studies in children with autism and in patients with FXS and in a controlled trial of ampakine CX516 in FXS. All ABC subscales showed good reliability when used by parents and caregivers of individuals with FXS to assess behavior in the CX516 study NCT00054730, and yielded intraclass correlation coefficient (ICC) values of 0.7-0.9.|Baseline and 8 weeks|ABC-I change in subjects completing 8 weeks of minocycline treatment||units on a scale||Standard Deviation|Mean
788641|NCT00858780|Secondary|Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization|Percentage of participants who were treatment failure over 48 weeks as per potentially predictor variables (at randomization) are reported: number of swollen joints/tender joints, DAS28, PGA, PtGA, participant general health VAS, participant pain VAS, clinical disease activity index (CDAI), simplified disease activity index (SDAI), ESR (mm/hour), plasma CRP (mg/L), sensitive serum CRP (mg/L), anti- cyclic citrullinated peptide (anti CCP, units/mL), cartilage oligomeric matrix protein (COMP, units/liter), S-score, O-score, E-score, Joint space narrowing score, erosion score, and mTSS.|Randomization (Week 0) up to Week 48|m-ITT analysis set.||percentage of participants|||Number
788642|NCT00858780|Secondary|Change From Randomization in Magnetic Resonance Imaging (MRI) Findings (O-Score, E-Score) at Week 12|MRI of hand/wrist of dominant hand was scored for signs of synovitis (S-score), bone edema (O-score), and bone erosions (E-score) as per OMERACT. O-score: 0 (no volume increment) to 3 (100% volume increment) in 23 hand/wrist joints; total score 0 to 69, higher scores=more edema. E-score: 0 (no volume occupied by erosion) to 10 (100% volume occupied by erosion) in 23 hand/wrist joints; total score 0 to 230, higher scores=more erosion.|Randomization (Week 0), Week 12|m-ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this measure.||units on a scale||Full Range|Median
788643|NCT00858780|Secondary|Change From Randomization in Magnetic Resonance Imaging (MRI) Findings (S-Score) at Week 12|MRI of hand/wrist of dominant hand was scored for signs of synovitis (S-score), bone edema (O-score), and bone erosions (E-score) as per OMERACT. S-score: 0 (normal) to 3 (severe) for each of distal radioulnar, radiocarpal, intercarpal-carpometacarpal, second to fifth metacarpophalangeal joints; total score 0 to 21, higher score=severe synovitis.|Randomization (Week 0), Week 12|m-ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this measure.||units on a scale||Standard Error|Least Squares Mean
788644|NCT00858780|Secondary|Magnetic Resonance Imaging (MRI) Findings at Randomization|MRI of hand/wrist of dominant hand scored for signs of synovitis (S-score), bone edema(O-score), bone erosions (E-score) as per outcome measures in RA clinical trials (OMERACT). S-score:0(normal)-3(severe) for distal radioulnar,radiocarpal,intercarpal-carpometacarpal,second-fifth metacarpophalangeal joints, total score(TS)0-21, higher score(HS)=severe synovitis. O-score:0(no volume increment)-3(100% volume increment) in 23 hand/wrist joints, TS 0-69, HS=more edema. E-score:0(no volume occupied by erosion)-10(100% volume occupied by erosion) in 23 hand/wrist joints, TS 0-230, HS=more erosion.|Randomization (Week 0)|m-ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
788645|NCT00858780|Secondary|Change From Randomization in Modified Total Sharp Score (mTSS) at Week 48|mTSS = sum of erosion and Joint Space Narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change: scores at observation minus score at randomization. An increase in mTSS from randomization represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Randomization (Week 0), Week 48|m-ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants evaluable for each time point for each treatment arm, respectively.||units on a scale||Full Range|Median
788646|NCT00858780|Secondary|Change From Randomization in C-Reactive Protein (CRP) Level at Week 6, 12, 18, 24, 30, 36, 42, and 48|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is <10 milligram per liter (mg/L). A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48|m-ITT analysis set. Here, ‘n’ signifies participants evaluable for each time point for each treatment arm, respectively.||mg/L||Full Range|Median
789190|NCT00861692|Primary|Composite of All-cause Death, Thrombosis (New and Extended) and Unplanned Amputation||During and 30 days after argatroban treatment|||participants|||Number
788647|NCT00858780|Secondary|Change From Randomization in Erythrocyte Sedimentation Rate (ESR) at Week 6, 12, 18, 24, 30, 36, 42, and 48|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeter per hour (mm/hour). A higher rate is consistent with inflammation.|Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48|m-ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants evaluable for each time point for each treatment arm, respectively.||mm/hour||Full Range|Median
788648|NCT00858780|Secondary|Change From Randomization in Morning Stiffness Duration at Week 6, 12, 18, 24, 30, 36, 42, and 48|Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. The duration of morning stiffness was determined by asking the following questions: 1) Over the last 2 days, when did you wake in the morning? 2) Over the last 2 days, when were you able to resume your normal activities without stiffness? Increase in stiffness duration from randomization represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48|m-ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants evaluable for each time point for each treatment arm, respectively.||minutes||Full Range|Median
788649|NCT00858780|Secondary|Change From Randomization in Participant Pain Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48|Participants indicated the amount of pain experience during the last 2-3 days by marking a vertical line on 100 mm VAS. Intensity of pain range: 0 = no pain to 100 = pain as bad as it could be.|Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48|m-ITT analysis set.||mm||Standard Error|Least Squares Mean
788650|NCT00858780|Secondary|Participant Pain Visual Analog Scale (VAS) at Randomization|Participants indicated the amount of pain experience during the last 2-3 days by marking a vertical line on 100 mm VAS. Intensity of pain range: 0 = no pain to 100 = pain as bad as it could be.|Randomization (Week 0)|m-ITT analysis set.||mm||Standard Deviation|Mean
788651|NCT00858780|Secondary|Change From Randomization in Participant General Health Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48|Participants answered “in general how would you rate your health over the last 2-3 weeks?” Participants responded by using a 0 to 100 mm VAS, where 0 mm = very well and 100 mm = extremely bad.|Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48|m-ITT analysis set.||mm||Standard Error|Least Squares Mean
788652|NCT00858780|Secondary|Participant General Health Visual Analog Scale (VAS) at Randomization|Participants answered “in general how would you rate your health over the last 2-3 weeks?” Participants responded by using a 0 to 100 mm VAS, where 0 mm = very well and 100 mm = extremely bad.|Randomization (Week 0)|m-ITT analysis set.||mm||Standard Deviation|Mean
788653|NCT00858780|Secondary|Change From Randomization in Participant Global Assessment (PtGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48|Participants assessed the overall activity of their rheumatoid arthritis (RA) on a 0 to 100 mm VAS, where 0 mm = no disease activity and 100 mm = extreme disease activity.|Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48|m-ITT analysis set. Here, ‘n’ signifies participants evaluable for each time point for each treatment arm, respectively.||mm||Full Range|Median
788654|NCT00858780|Secondary|Change From Randomization in Physician Global Assessment (PGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48|PGA of disease activity was measured on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS), with 0 mm = no disease activity and 100 mm = extreme disease activity.|Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48|m-ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants evaluable for each time point for each treatment arm, respectively.||mm||Full Range|Median
788655|NCT00858780|Secondary|Change From Randomization in Swollen Joints Count (SJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48|Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1. A negative value in change from randomization indicates an improvement.|Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48|m-ITT analysis set. Here, ‘n’ signifies participants evaluable for each time point for each treatment arm, respectively.||swollen joints||Full Range|Median
788656|NCT00858780|Secondary|Change From Randomization in Tender Joints Count (TJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48|Number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1. A negative value in change from randomization indicates an improvement.|Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48|m-ITT analysis set. Here, ‘n’ signifies participants evaluable for each time point for each treatment arm, respectively.||tender joints||Full Range|Median
788657|NCT00858780|Secondary|Change From Randomization in Disease Activity Score Based on 28-Joint Count (DAS28) at Week 6, 12, 18, 24, 30, 36, 42, and 48|DAS28 calculated from SJC and PJC using the 28 joints count, the ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity and <2.6=remission.|Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48|m-ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this measure.||units on a scale||Standard Error|Least Squares Mean
788658|NCT00858780|Secondary|Disease Activity Score Based on 28-Joint Count (DAS28) at Randomization|DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PtGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 implied low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity and less than (<) 2.6=remission.|Randomization (Week 0)|m-ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
789191|NCT00861705|Secondary|Incidence and Severity of Post-op Complications, Namely Excessive Bleeding, Delayed Wound Healing, and Wound Dehiscence.|Assessed by physician observation.|at definitive surgery, up to 28 weeks|||percentage of participants with event||95% Confidence Interval|Number
788659|NCT00858780|Secondary|Percentage of Visits During Which Participants Were in Remission or Low Disease Activity State|Participants who had DAS28 <=3.2 were considered in remission or LDA state. Percentage of visits during which a participant was in remission or LDA state was calculated as number of visits in which participant was in remission or LDA divided by total number of visits multiplied by 100.|Randomization (Week 0) up to Week 48|m-ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this measure.||percentage of visits||Standard Deviation|Mean
788660|NCT00858780|Secondary|Percentage of Participants With Remission or Low Disease Activity (LDA)|Participants who had DAS28 less than or equal to (<=) 3.2 were considered in remission or LDA state.|Baseline (Week -8), Week -4, Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48|m-ITT analysis set. Here, ‘n’ signifies participants evaluable for each time-point for each treatment arm, respectively.||percentage of participants|||Number
788661|NCT00858780|Secondary|Time to Treatment Failure (TTF)|TTF (in weeks): (date of failure minus date of randomization) divided by 7. Date of failure was ordinary visit date or extra visit date in case of failure (extra visit was within 2 weeks from the date a participant experienced significant disease progression between visits and wanted to withdraw from Period 2), or date of withdrawal due to disease progression. Participants who did not have a treatment failure were censored at their last evaluation visit. Participants who withdrew from the study prematurely and did not have a treatment failure were censored on the date of their withdrawal.|Randomization (Week 0) up to date of failure, withdrawal due to disease progression or last evaluation visit (Week 48)|m-ITT analysis set.||weeks||95% Confidence Interval|Median
788662|NCT00858780|Primary|Percentage of Participant Who Were Non-Failures|A participant was considered as non-failure if the calculated DAS28 <=3.2 at all visits or if the calculated DAS28 >3.2, the increase of calculated DAS28 from randomization (Week 0): was <0.6 at all visit or was >=0.6 but <1.2 on no more than 1 consecutive visit. Percentage of participants who were non-failures calculated based on DAS28 and disease progression as determined by investigator or participant.|Week 48|Modified intent-to-treat (m-ITT) analysis set included all randomized participants who received at least 1 dose of study medication after randomization and had at least 1 available evaluation after the first administration of study medication after randomization.||percentage of participants|||Number
788663|NCT00858832|Primary|Endometritis Incidence|Number of participants who developed endometritis|One year|||participants|||Number
788664|NCT00858845|Other Pre-specified|Muscle Sympathetic Nerve Activity|Muscle sympathetic nerve activity will be measured as bursts sympathetic nerve activity per minute.|3 months||||||
788665|NCT00858845|Secondary|Muscle Fiber Type|Fibers witll be typed as I or II according to presence of myosin heavy chain|Measured at Month 3||||||
788666|NCT00858845|Primary|Citrate Synthase Activity|Citrate synthesis is an estimate of mitochondrial activity|Measured at Month 3|||micromole/min/100mg wet weight||Standard Error|Mean
788667|NCT00858858|Primary|Protection Against DNA Damage by UDCA|p-H2AX levels are a measure of DNA damage. Our major outcome measure is the change in p-H2AX levels, expressed as relative densitometry units, after DCA perfusion in patients treated with oral UDCA. If UDCA protects against bile acid-induced DNA damage, then p-H2AX levels before and after perfusion should not change significantly.|After 8 weeks of UDCA treatment|Patients with Barrett's esophagus, only metaplastic epithelium evaluated. No data were collected from squamous epithelium as originally planned because our in vitro studies subsequently showed that DCA exposure did not cause DNA damage in squamous cells and, therefore, oral UDCA treatment would be meaningless for squamous esophagus.||Relative Densitometry Units||Standard Error|Mean
788668|NCT00858962|Primary|Area Under the Curve (AUC) of BUP/NLX With Raltegravir (hr*ng/mL)|PK parameters of BUP were determined by non-compartmental methods. AUC of BUP was determined by use of the trapezoidal rule.|6-14 days after beginning co-administration of drugs|All subjects who completed study were included in the analysis.||hr*ng/mL||Standard Deviation|Mean
788669|NCT00859014|Secondary|Functional Outcome|Modified Rankin Scale (mRS) Score. The mRS is a six point (scored: 0 - 5) scale that measures post stroke disability. A seventh category (mRS = 6) is for patients who have died. A higher score indicates greater degree of disability. Patients scoring '5' are bed ridden, where as those scoring '0' are completely symptom free and independent.|90-days|||units on a scale||Inter-Quartile Range|Median
788670|NCT00859014|Primary|Study Related Serious Adverse Events (SR-SAE)|"Study Related Serious Adverse Events (SAE) as adjudicated by the DSMB - Events"|2 Years|||Events|||Number
788671|NCT00859027|Secondary|Bone Turnover Markers||6 and 12 months||||||
788672|NCT00859027|Primary|Bone Mineral Density at Spine at Baseline Bone Mineral Density at Spine at 6 Months|BMD measurement is mean % change of group compared with baseline|% change in BMD at 6 months compared to baseline values at spine and hip|The number that completed the study.||percentage change of BMD from baseline||Standard Error|Mean
788695|NCT00859222|Other Pre-specified|Overall Survival (OS) [Phase I]|OS is defined as the time from study entry to death or date last known alive.|Participants were followed long-term for survival every 4 months from the end of treatment until death or lost to follow-up. Phase I participants were followed for OS up to 12.1 months on this study.|All participants who received at least one dose of the study drug were followed for OS.||months||Full Range|Median
788679|NCT00859053|Secondary|Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Who Died|AE was defined as any new unfavorable symptom, sign, or disease or worsening of a pre-existing condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Study Discharge (end of study) was Day 4 (healthy participants) or Day 5 (hepatically impaired participants).|Day 1 to end of study for AEs and, Day 1 to up to 30 days after last dose for SAE.|Analysis was done in safety population, defined as all the participants who received study medication.||Participants|||Number
788680|NCT00859053|Primary|The Apparent Volume of Distribution at Steady State (Vss/F)|Apparent volume of distribution was calculated by dividing the product of the dose and mean residence time (MRT) by AUC(INF). AUC(INF) was estimated as AUC(0-T) + Ct/λ z, where λ z was the terminal elimination rate constant and Ct was the last observable concentration.|Pre-dose (0), 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose (both healthy and hepatically impaired participants) and 96 hours post-dose (only for hepatically impaired participants)|Analysis was performed in PK population.||mL||Geometric Coefficient of Variation|Geometric Mean
788681|NCT00859053|Primary|Apparent Clearance of Free BMS-790052 (CLu/F)|CLu/F was calculated by dividing the apparent total body clearance (CLT/F) by mean fraction of unbound drug (fu) for both (1 hour and 4 hour post dose) time points combined. Apparent total body clearance was calculated as dose/AUC(INF). AUC(INF) was estimated as AUC(0-T) + Ct/ λz, where λz was the terminal elimination rate constant and Ct was the last observable concentration.|Pre-dose (0), 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose (both healthy and hepatically impaired participants) and 96 hours post-dose (only for hepatically impaired participants)|Analysis was performed in PK population.||mL/min||Geometric Coefficient of Variation|Geometric Mean
788682|NCT00859053|Primary|Apparent Total Body Clearance (CLT/F) of BMS-790052|Apparent total body clearance was calculated as dose/AUC(INF). AUC(INF) was estimated as AUC(0-T) + Ct/λ z, where λ z was the terminal elimination rate constant and Ct was the last observable concentration.|Pre-dose (0), 0.5,1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose (both healthy and hepatically impaired participants) and 96 hours post-dose (only for hepatically impaired participants)|Analysis was performed in PK set population.||milliliter/minute (mL/min)||Geometric Coefficient of Variation|Geometric Mean
788683|NCT00859053|Primary|Terminal Half-life (T-HALF) of BMS-790052|Terminal half-life was the time required for one half of the total amount of administered drug eliminated from the body.|Pre-dose (0), 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose (both healthy and hepatically impaired participants) and 96 hours post-dose (only for hepatically impaired participants)|Analysis was performed in the Pharmacokinetic population (all participants who received study drug and had adequate PK profiles).||hours||Standard Deviation|Mean
788684|NCT00859053|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of BMS-790052|Tmax was defined as the time required to reach maximum observed plasma concentration. Tmax was directly determined from the raw plasma concentration-time data.|Pre-dose (0), 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose (both healthy and hepatically impaired participants) and 96 hours post-dose (only for hepatically impaired participants)|Analysis was performed in the Pharmacokinetic population (all participants who received study drug and had adequate PK profiles).||hours||Full Range|Median
788685|NCT00859053|Primary|Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of BMS-790052|AUC(INF) was estimated as AUC(0-T) + Ct/λ z, where λ z was the terminal elimination rate constant and Ct was the last observable concentration.|Pre-dose (0), 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose (both healthy and hepatically impaired participants) and 96 hours post-dose (only for hepatically impaired participants)|Analysis was performed in the Pharmacokinetic population (all participants who received study drug and had adequate PK profiles).||ng* h/mL||Geometric Coefficient of Variation|Geometric Mean
788686|NCT00859053|Primary|Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Last Measurable Concentration [AUC(0-T)] of BMS-790052|AUC(0-T) was calculated by the sum of linear trapezoids using non-compartmental analysis.|Pre-dose (0), 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose (both healthy and hepatically impaired participants) and 96 hours post-dose (only for hepatically impaired participants)|Analysis was performed in the Pharmacokinetic population (all participants who received study drug and had adequate PK profiles).||ng*hour (h)/mL||Geometric Coefficient of Variation|Geometric Mean
788687|NCT00859053|Primary|Maximum Observed Plasma Concentration (Cmax) of BMS-790052|Maximum observed plasma concentration following drug administration from the raw plasma concentration-time data. The plasma samples were analysed for BMS-790052 by using a validated liquid chromatography tandem mass spectrometric (LC-MS/MS) assay.|Pre-dose (0), 0.5,1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose (both healthy and hepatically impaired participants) and 96 hours post-dose (only for hepatically impaired participants)|Analysis was performed in the Pharmacokinetic population (all participants who received study drug and had adequate PK profiles).||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
788688|NCT00859131|Secondary|Incidence of Thrombocytopenia, Defined as a Platelet Count of Less Than 100,000 Cells/mm3||One year|||participants|||Number
788696|NCT00859222|Secondary|Overall Survival [Phase II]|OS is defined as the time from study entry to death or date last known alive.|Participants were followed long-term for survival every 4 months from the end of treatment until death or lost to follow-up. Phase II participants were followed for OS up to 27 months on this study.|All participants who received at least one dose of the study drug were followed for OS.||months||Full Range|Median
788697|NCT00859222|Other Pre-specified|6-Month Progression-Free Survival (PFS6) [Phase I]|PFS6 is the proportion of patients remaining alive and progression-free at 6-months from study entry. Progressive disease was established based on Response Assessment in Neuro-Oncology (RANO) criteria (Wen et al JCO 2010).|Disease was assessed radiographically to document clinical progression every cycle on treatment and post-treatment every 8 weeks up to 12 months. Participants were followed for PFS6 up to 6 months since study entry.|All participants with measurable disease present at baseline and received at least one dose of the study drug were evaluable for PFS6.||proportion of participants||95% Confidence Interval|Number
788698|NCT00859222|Other Pre-specified|Progression-Free Survival (PFS) [Phase I]|PFS is defined as the time from study entry to the earliest documentation of disease progression or death. Patients alive without evidence of PD were censored at the date of last disease assessment. Progressive disease was established based on Response Assessment in Neuro-Oncology (RANO) criteria (Wen et al JCO 2010).|Disease was assessed radiographically to document clinical progression every cycle on treatment and post-treatment every 8 weeks up to 12 months.|All participants with measurable disease present at baseline and received at least one dose of the study drug were evaluable for PFS.||months||Full Range|Median
788699|NCT00859222|Secondary|Progression-Free Survival (PFS) [Phase II]|PFS is defined as the time from study entry to the earliest documentation of disease progression or death. Patients alive without evidence of PD were censored at the date of last disease assessment.|Disease was assessed radiographically to document clinical progression every cycle on treatment and post-treatment every 8 weeks up to 12 months.|All PII participants with measurable disease present at baseline and received at least one dose of the study drug were evaluable for PFS.||months||Full Range|Median
788700|NCT00859222|Secondary|Best Radiographic Response|Radiographic response was established based on Response Assessment in Neuro-Oncology (RANO) criteria (Wen et al JCO 2010) with 5 potential categories: Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive disease (PD) and Unknown status.|Disease was assessed radiographically for response every cycle on treatment. Treatment duration in cycles was a median (range) of 2 (1-6) PI Cohort 1, 4.5 (2-6) PI Cohort 2, 6 (2-10) PI Cohort 3, 5 PII GBM and 7 PII AG.|All participants with measurable disease present at baseline and received at least one dose of the study drug were evaluable for response.||participants|||Number
788701|NCT00859222|Primary|6-Month Progression-Free Survival (PFS6) [Phase II]|PFS6 is the proportion of patients remaining alive and progression-free at 6-months from study entry. Progressive disease was established based on RANO criteria (Wen et al JCO 2010).|Disease was assessed radiographically to document clinical progression every cycle on treatment and post-treatment every 8 weeks up to 12 months. Participants were followed for PFS6 up to 6 months since study entry.|All participants with measurable disease present at baseline and received at least one dose of the study drug were evaluable for PFS6.||proportion of participants||95% Confidence Interval|Number
788702|NCT00859222|Primary|Dose Limiting Toxicity (DLT) [Phase I]|A DLT was defined as an adverse event that (a) is related to the LBH589 and/or bevacizumab with an attribution of possible, probable, or definite, and (b) occurs during and/or begins during the first 30 days of the study treatment, and (c) meets any of the following criteria: grade 3 thrombocytopenia; grade 4 neutropenia lasting 7 days; grade 4 anemia lasting 7 days despite transfusion or growth factors; febrile neutropenia if ANC<0.5 x10^9/L; a QT interval corrected for heart rate (QTc) of 500–515 msec that did not stabilize to <480 msec after one week; a second occurrence of QTc 500–515 msec; any QTc >515 msec; any deep vein thrombosis (DVT) or pulmonary embolism (PE) while on fully therapeutic anticoagulation therapy; Grade 3 proteinuria lasting 14 days; or any other clinically significant Grade 3 toxicity despite maximal medical therapy lasting 7 days, any Grade 4 toxicity despite maximal medical therapy; or any Grade 3 or 4 toxicity resulting in study drug discontinuation.|Participants were assessed every 2 weeks while on study; The observation period for DLT evaluation was the first 30 days of treatment.|All PI participants who received at least one dose of the study drug were evaluable for DLT.||participants with DLT|||Number
788703|NCT00859222|Primary|LBH589 Maximum Tolerated Dose (MTD) [Phase I]|The MTD LBH589 in combination with bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle is determined by the number of patients who experience a dose limiting toxicity (DLT). See subsequent primary outcome measure for the DLT definition. The MTD is defined as the highest dose at which fewer than one-third of patients experience a DLT. If no DLTs are observed, the MTD is not reached but the highest dose received may be the Recommended Phase II Dose (RP2D). The MTD was not reached with 0 of 6 DLTs observed in the highest dose cohort but due to safety concerns higher doses of LBH589 with bevacizumab were neither planned nor tested. The RP2D was 30 mg/day orally, 3x per week, every other week.|Participants were assessed every 2 weeks while on study; The observation period for MTD evaluation was the first 30 days of treatment.|All PI participants who received at least one dose of the study drug were evaluable for MTD.||mg/day orally, 3x per wk, every other wk|||Number
788704|NCT00859313|Primary|Percent of Patients Without Device Failure|Percent of patients who completed the study without a device failure. A device failure is defined as the failure to dispense a NanoTab, dispensing more than one NanoTab, or dispensing a broken NanoTab. Device failures were monitored and reported by study staff.|12 hours|||percent|||Number
788705|NCT00859339|Secondary|Correlate Biomarker Expression|To evaluate the impact of sunitinib malate in combination with cisplatin and gemcitabine on expression of selected biomarkers.|18 months|No data was collected or analyzed for the secondary objective due to termination of the trial (toxicity)|||||
788706|NCT00859339|Secondary|Progression Free Survival||18 months|No data was collected or analyzed for the secondary objective due to termination of the trial (toxicity)|||||
788707|NCT00859339|Secondary|Objective Response Rate|To determine the objective response rate for patients with measurable disease according to RECIST.|18 months|No data was collected or analyzed for the secondary objective due to termination of the trial (toxicity)|||||
788708|NCT00859339|Secondary|Safety Profile|Evaluate the safety profile of Neoadjuvant Cisplatin, Gemcitabine, Sunitinib Malate + Radical Cystectomy in participants with TCC|18 months|||participants|||Number
788710|NCT00859430|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||mcg*h/mL||Standard Deviation|Mean
788711|NCT00859430|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||mcg*h/mL||Standard Deviation|Mean
788712|NCT00859430|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||mcg/mL||Standard Deviation|Mean
788713|NCT00859469|Secondary|Progression-free Survival|Time to radiologic disease progression or death|50 months|||months||95% Confidence Interval|Median
788714|NCT00859469|Secondary|Overall Survival||50 months|ITT||months||95% Confidence Interval|Median
788715|NCT00859469|Primary|Best Response|Radiologic response by RECIST criteria|Two months|intention to treat principle||participants|||Number
788716|NCT00859508|Secondary|Radiographic Evaluation|"Radiographic evaluation (to determine the presence or absence of the following at the 6 month follow-up visit)
Adhesion formation
Membrane formation
Abnormal thickening along graft (device implant) site
Brain edema adjacent to graft (device implant) site"|6 months||||||
788717|NCT00859508|Secondary|Device Handling Characteristics (i.e., Ease of Use, Strength, Suturability, Seal Quality)||up to 6 months||||||
788718|NCT00859508|Secondary|Wound Healing Assessment||up to 6 months||||||
788719|NCT00859508|Secondary|Assessment of Changes in Body Systems (e.g., Head, Neurovascular, Etc.)||up to 6 months||||||
788720|NCT00859508|Secondary|Modified Rankin Scale (Patient Function Assessment)||up to 6 months||||||
788721|NCT00859508|Primary|Absence of Cerebrospinal Fluid (CSF) Fistula and Pseudomeningocele|The primary endpoint for measuring effectiveness is such that an individual patient's treatment success requires the absence of CSF fistula (drainage from wound or sinus) and pseudomeningocele within 6 months post-operatively confirmed by radiographic evaluation and physical examination of the surgical site.|6 months|||participants|||Number
788722|NCT00859521|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||mcg*h/mL||Standard Deviation|Mean
788723|NCT00859521|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||mcg*h/mL||Standard Deviation|Mean
788724|NCT00859521|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||mcg/mL||Standard Deviation|Mean
788725|NCT00859547|Primary|Number of Participants With a High International Normalized Ratio (INR) of Prothrombin Time of Grade 0 or Higher|Grade 0=normal.|Baseline and Day 29 from Baseline|Participants who received treatment with rThrombin.||Participants|||Number
788726|NCT00859547|Primary|Number of Participants With Elevations in the Coagulation Parameter of Activated Partial Thromboplastin Time (aPPT)of Grade 0 or Higher|ULN=upper limit of normal. Grade 0=normal; Grade 1=ULN to 1.5 x ULN.|Baseline and Day 29 from Baseline|Participants who received treatment with rThrombin.||Participants|||Number
788727|NCT00859547|Primary|Number of Participants With Clinical Laboratory Findings of Grade 0 or Higher in Creatinine Levels|ULN=upper level of normal. Grade 0=normal; Grade 1=>ULN to 1.5 x ULN.|Baseline and Day 29 from Baseline|Participants who received treatment with rThrombin.||Participants|||Number
788728|NCT00859547|Primary|Number of Participants With Clinical Laboratory Findings of Grade 0 or Higher in Hemoglobin Levels|LLN=lower level of normal. Grade 1=100 g/L to <LLN; Grade 2=80 to <100 g/L; Grade 3=65 to <80 g/L; Grade 4=<65 g/L.|Baseline and Day 29 from Baseline|Participants who received treatment with rThrombin.||Participants|||Number
788729|NCT00859547|Primary|Number of Participants With Clinical Laboratory Findings of Grade O or Higher in Platelet, White Blood Cell (WBC), Lymphocyte, and Neutrophil Counts|Abnormal laboratory findings were recorded as AEs when considered clinically significant (unusual for the surgical population or individual participant) by the investigator, when associated with symptoms, when requiring specific treatment, or when requiring a change in participant management.LLN=lower level of normal. Platelets: Grade 0=normal. WBC: Grade 0=normal. Lymphocytes: Grade 0=normal; Grade 1=<LLN x 0.8–10^9/L. Neutrophils: Grade 0=normal; Grade 1=<LLN–1.5x10^9/L; Grade 2=<1.5–1.0x10^9/L|Baseline and Day 29 from Baseline|Participants who received treatment with rThrombin.||Participants|||Number
788730|NCT00859547|Secondary|Number of Participants WIth Positive Findings for Anti-rThrombin Product Antibody|Antibody-positive was defined as seroconversion or ≥1.0 unit (≥10-fold) increase in titer compared with antibody titer at baseline.|At Day 29|Participants who received study drug and had both baseline and on-treatment anti-rThrombin product antibody assessments.||Participants|||Number
788731|NCT00859547|Primary|Number of Participants With AEs by Maximum Severity|An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. Mild=asymptomatic or minor symptoms; intervention not indicated. Moderate=requiring only minimal, local, or noninvasive intervention. Severe=significant symptoms but not life-threatening; hospitalization or invasive intervention indicated. Life-threatening=indicating intensive care or urgent invasive intervention.|Days 1 through 29, continuously|Participants who received treatment with rThrombin.||Participants|||Number
788732|NCT00859547|Primary|Number of Participants With Death, Serious Adverse Events, Treatment-related Adverse Events (AE), AEs Leading to Discontinuation, and AEs of Hypersensitivity|An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=possibly, probably, or certainly related to and of unknown relationship to study treatment|Days 1 through 29, continuously|Participants who received treatment with rThrombin.||Participants|||Number
788738|NCT00859586|Secondary|Incidence and Severity Induced GvHD, Proportion of DLI Engraftment, Peak Chimerism, Leukemia Response at Days Post DLI, Residual Leukemia Measured by Patient Chimerism, Leukemia Free Survival From Date Relapse, Safety of Mismatched DLI Procedure...||Severity of GvHD.||||||
788739|NCT00859586|Primary|Overall Recipient Survival at 6-month Post-relapse of Disease|This phase II clinical trial is designed to evaluate a novel non-myeloablative but highly immunosuppressive disease specific conditioning regimen and infusion of unmanipulated lymphocytes from a haplo-identical familial donor in subjects with relapsed disease following matched sibling stem cell transplantation who are not candidates for alternative treatment options. The clinical trial will evaluate recipient survival at six months post-relapse of disease.|6 months post-relapse of disease|||participants|||Number
788740|NCT00859638|Secondary|Eight Foot Walk Test||4 months||||||
788741|NCT00859638|Secondary|Balance Screen||4 months||||||
788742|NCT00859638|Secondary|Primary Care Resources and Supports||4 months||||||
788743|NCT00859638|Secondary|Patient Assessment of Chronic Illness Care||4 months||||||
788744|NCT00859638|Secondary|Two Minute Walk Test||4 months||||||
788745|NCT00859638|Secondary|Grip Strength||4 months||||||
788746|NCT00859638|Secondary|Rapid Assessment of Physical Activity||4 months||||||
788747|NCT00859638|Secondary|Self-efficacy for Chronic Disease Scale||4 months||||||
788748|NCT00859638|Secondary|Health Care Utilization||4 months||||||
788749|NCT00859638|Secondary|Self-rated Health||4 months||||||
788750|NCT00859638|Primary|Physical Functioning Inventory (PFI)|The PFI is used to assess physical functioning in older adults. It contains 21 tasks from 4 subscales: activities of daily living, instrumental activities of daily living, mobility, moderate activities. A series of questions is used to determine whether the person experiences difficulty in completing a task, the level of difficulty they experience, and any changes to the method and/or frequency of task performance. The PFI is sensitive to steps in the natural history of functional decline that are often not assessed clinically. Range of scores: 0 (most difficulty); 100 (least difficulty).|4 months|||units on a scale||Standard Deviation|Mean
788751|NCT00859651|Secondary|Change in Percent Density|Assessed by mammography and breast MRI.|Baseline to 1 year|Data for this study (NCT00859651; n=20) is combined with the data for another study (NCT00976339; n=20).||percentage of breast density||Standard Deviation|Mean
788752|NCT00859651|Primary|Change in Serum 25(OH)D|25(OH)D level at the end of one year intervention|Baseline to 1 year|Data for this study (NCT00859651; n=20) is combined with the data for another study (NCT00976339; n=20).||ng/ml||Standard Deviation|Mean
788753|NCT00851890|Secondary|Number of Participants With Maximal Phenotypic Resistance to ABT-333 >10 Fold Relative to Baseline Through Day 28|Phenotypic resistance to ABT-333 was assessed by calculating the fold difference in the half maximal effective concentration (EC50) compared with the EC50 for the corresponding baseline sample, and the maximal fold change in EC50 from baseline over the Day 5-28 period. The resistance sample drawn before the first dose of ABT-333 on Day 1 was defined as the baseline sample. The number of participants with phenotypic resistance in the post-baseline samples are presented.|Days 1 through 28|Participants received at least 1 dose of study drug and had at least 1 post-baseline measurement of HCV RNA.||participants|||Number
788754|NCT00851890|Secondary|Number of Participants With Resistance-Associated Variants in Non-structural Viral Protein 5B (NS5B) Through Day 28|Samples from Days 1, 5, 10, 17, 24 and 28 were analyzed for the presence of resistance-associated amino acids using population sequencing and compared to the baseline non-structural viral protein 5B (NS5B) sequence to assess amino acid changes. The amino acid sequence of NS5B before the first dose of ABT-333 on Day 1 was defined as the baseline sequence. The number of participants with variants at resistance-associated amino acid positions in the post-baseline samples are presented.|Days 1, 5, 10, 17, 24 and 28|Participants received at least 1 dose of study drug and had at least 1 post-baseline measurement of HCV RNA. When a different number of participants at a specific timepoint was used to analyze the data in the outcome measure, the n (number of participants) for each arm is denoted in the Category Title.||participants|||Number
788755|NCT00851890|Secondary|Percentage of Participants With Hepatitis C Virus Ribonucleic Acid (HCV RNA) Levels ≤ 10 IU/mL (Lower Limit of Detection [LLOD]) at Day 28 or Final Visit|Serum hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase polymerase chain reaction (RT-PCR) assay. The lower limit of detection (LLOD) was defined as a HCV RNA level equal to 10 IU/mL. Data are reported as the percentage of participants.|Day 28 or Final Visit|Participants received at least 1 dose of study drug and had at least 1 post-baseline measurement of hepatitis C virus ribonucleic acid (HCV RNA).||percentage of participants|||Number
788756|NCT00851890|Secondary|Percentage of Participants With Hepatitis C Virus Ribonucleic Acid (HCV RNA) Levels ≤ 25 IU/mL (the Lower Limit of Quantitation [LLOQ]) at Day 28 or Final Visit|Serum hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase polymerase chain reaction (RT-PCR) assay. The lower limit of quantification (LLOQ) was defined as HCV RNA levels ≤ 25 IU/mL. Data are reported as the percentage of participants.|Day 28 or Final Visit|Participants received at least 1 dose of study drug and had at least 1 post-baseline measurement of hepatitis C virus ribonucleic acid (HCV RNA).||percentage of participants|||Number
788812|NCT00852761|Secondary|Dermatology Quality of Life - Treatment|"Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions.
Sum of scores for question 10. Score range from 0 to 3. A higher score denotes a more impaired quality of life"|Baseline, Days 3, 8, 15|ITT (Note: some subjects did not complete the survey at all timepoints; however, all data available was analyzed.)||units on a scale||Standard Deviation|Mean
788757|NCT00851890|Secondary|Percentage of Participants With at Least a 2 log10 Maximal Decrease in Hepatitis C Virus Ribonucleic Acid (HCV RNA) Levels During ABT-333 Treatment|Serum hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined using a real-time reverse transcriptase polymerase chain reaction (RT-PCR) assay. The baseline value was the HCV RNA measurement before the first dose of ABT-333 on Day 1. Data are reported as the percentage of participants.|Prior to the first dose on Day 1 and Day 28|Participants received at least 1 dose of study drug and had at least 1 post-baseline measurement of HCV RNA.||percentage of participants|||Number
788758|NCT00851890|Secondary|Change From Baseline in Hepatitis C Virus Ribonucleic Acid (HCV RNA) Levels Through Day 28 or Final Visit|Serum hepatitis C virus ribonucleic acid (HCV RNA) levels (reported as log10 IU/mL) were determined using a real-time reverse transcriptase polymerase chain reaction (RT-PCR) assay. The baseline value was the HCV RNA measurement before the first dose of ABT-333 on Day 1 and the Day 28 or Final Visit value was the last HCV RNA measurement during the study. Data are reported as the least squares mean change from baseline ± standard error.|Day 28 and Final Visit|Participants received at least 1 dose of study drug and had at least 1 post-baseline measurement of HCV RNA. When a different number of participants at a specific timepoint was used to analyze the data in the outcome measure, the n (number of participants) for each arm is denoted in the Category Title.||log10 IU/mL||Standard Error|Least Squares Mean
788759|NCT00851890|Primary|Number of Participants Having Treatment-emergent Adverse Events (AEs)|"An AE was any untoward medical occurrence that did not have a causal relationship with treatment. An Adverse Drug Reaction (ADR) was any noxious and undesired reaction related to the experimental drug or experiment. A serious adverse event (SAE) was an AE that resulted in death, was life-threatening, resulted in or prolonged hospitalization, resulted in congenital anomaly, was persistent or caused significant disability/incapacity, spontaneous or elective abortion, or required intervention to prevent a serious outcome. AEs were rated for severity as either:
Mild - transient and easily tolerated;
Moderate - caused discomfort and interrupted usual activities;
Severe - caused considerable interference with usual activities, may be incapacitating or life-threatening.
AEs related to direct-acting antiviral agents (DAAs) were assessed as being either probably or possibly related by the investigator."|AEs were collected from the time of study drug administration to 30 days after last dose of study drug (8 Weeks)|Participants received at least 1 dose of study drug.||participants|||Number
788760|NCT00851890|Primary|Plasma Concentrations of Ribavirin (RBV)|Blood samples were collected prior to the morning dose on Day 3; 4 hours after the morning dose on Day 3; prior to the morning dose on Days 4 and 5; and single samples were collected on Days 10, 17, 24, and 28. The samples were analyzed for the concentration of RBV (measured in ng/mL) using validated analytical methods and estimated using non-compartmental methods. Data are reported as the mean ± standard deviation.|Prior to the morning dose on Day 3; 4 hours after the morning dose on Day 3; prior to the morning dose on Days 4 and 5; and single samples were collected on Days 10, 17, 24, and 28|Participants received at least 1 dose of study drug and had sufficient concentrations to characterize the pharmacokinetic parameters. When a different number of participants at a specific timepoint was used to analyze the data in the outcome measure, the n (number of participants) for each arm is denoted in the Category Title.||ng/mL||Standard Deviation|Mean
788761|NCT00851890|Primary|Serum Concentrations of Pegylated Interferon (pegIFN)|Blood samples were collected prior to the morning dose on Day 3; 4 hours after the morning dose on Day 3; prior to the morning dose on Days 4 and 5; and single samples were collected on Days 10, 17, 24, and 28. The samples were analyzed for the concentration of pegIFN (measured in ng/mL) using validated analytical methods and estimated using non-compartmental methods. Data are reported as the mean ± standard deviation.|Prior to the morning dose on Day 3; 4 hours after the morning dose on Day 3; prior to the morning dose on Days 4 and 5; and single samples were collected on Days 10, 17, 24, and 28|Participants received at least 1 dose of study drug and had sufficient concentrations to characterize the pharmacokinetic parameters. When a different number of participants at a specific timepoint was used to analyze the data in the outcome measure, the n (number of participants) for each arm is denoted in the Category Title.||ng/mL||Standard Deviation|Mean
788762|NCT00851890|Primary|Area Under the Plasma Concentration-time Curve From 0 to 12 Hours Post-dose (AUC12) of ABT-333|Blood samples were collected pre-dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and pre-dose on Day 2. The samples were analyzed for the concentration of ABT-333 using validated analytical methods. The area under the plasma concentration-time curve (AUC; measured in ng*hr/mL) measures the total exposure of a drug in blood plasma. The AUC12 of ABT-333 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Pre-dose (time 0 hours); 2, 4, 8, 12, and 16 hours post-dose on Day 1; and pre-dose on Day 2|Participants received at least 1 dose of study drug and had sufficient concentrations to characterize the pharmacokinetic parameters.||ng*hr/mL||Standard Deviation|Mean
788763|NCT00851890|Primary|Time to Maximum Plasma Concentration (Tmax) of ABT-333|Blood samples were collected pre-dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and pre-dose on Day 2. The samples were analyzed for the concentration of ABT-333 using validated analytical methods. The time to maximum plasma concentration (Tmax; measured in hours) is the time it takes for a drug to achieve Cmax. The Tmax of ABT-333 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Pre-dose (time 0 hours); 2, 4, 8, 12, and 16 hours post-dose on Day 1; and pre-dose on Day 2|Participants received at least 1 dose of study drug and had sufficient concentrations to characterize the pharmacokinetic parameters.||Hours||Standard Deviation|Mean
788764|NCT00851890|Primary|Maximum Plasma Concentration (Cmax) of ABT-333|Blood samples were collected pre-dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and pre-dose on Day 2. The samples were analyzed for the concentration of ABT-333 using validated analytical methods. The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that a drug achieves in the blood after administration in a dosing interval. The Cmax of ABT-333 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Pre-dose (time 0 hours); 2, 4, 8, 12, and 16 hours post-dose on Day 1; and pre-dose on Day 2|Participants received at least 1 dose of study drug and had sufficient concentrations to characterize the pharmacokinetic parameters.||ng/mL||Standard Deviation|Mean
789059|NCT00853996|Primary|Change in the Percentage of Breast Epithelial Cells Expressing Ki-67, From Baseline to 6 Months|Change in proliferation as measured by Ki-67 immunocytochemical expression in breast epithelial cells obtained by random periareolar fine needle aspiration at baseline and at 6 months.|Baseline to 6 months|||percentage of positive cells||Inter-Quartile Range|Median
788765|NCT00851890|Primary|Mean Maximal Change From Baseline in Hepatitis C Virus Ribonucleic Acid (HCV RNA) Levels Through Day 28|Serum hepatitis C virus ribonucleic acid (HCV RNA) levels (reported as log10 IU/mL) were determined for each sample using a real-time reverse transcriptase polymerase chain reaction (RT-PCR) assay. The baseline value was the HCV RNA measurement before the first dose of ABT-333 on Day 1. The maximal change during treatment was nadir minus the baseline log10 HCV RNA level. Nadir was defined as the lowest log10 HCV RNA level any time after the first dose of study drug on Day 1 through the last log10 HCV RNA level on Day 28. Data are reported as the least squares mean change from nadir ± standard error.|Prior to the first dose on Day 1 through Day 28|Participants received at least 1 dose of study drug and had at least 1 post-baseline measurement of HCV RNA.||log10 IU/mL||Standard Error|Least Squares Mean
788766|NCT00851890|Primary|Mean Maximal Change From Baseline in Hepatitis C Virus Ribonucleic Acid (HCV RNA) Levels During ABT-333 Monotherapy Treatment|Serum hepatitis C virus ribonucleic acid (HCV RNA) levels (reported as log10 IU/mL) were determined for each sample using a real-time reverse transcriptase polymerase chain reaction (RT-PCR) assay. The baseline value was the HCV RNA measurement before the first dose of ABT-333 on Day 1. The maximal change during monotherapy was nadir minus the baseline log10 HCV RNA level. Nadir was defined as the lowest log10 HCV RNA level any time after the first dose of study drug on Day 1 through the last log10 HCV RNA level before the first dose of study drug on Day 3. Data are reported as the least squares mean change from nadir ± standard error.|Prior to the first dose on Day 1 to before first dose on Day 3|Participants received at least 1 dose of study drug and had at least 1 post-baseline measurement of HCV RNA.||log10 IU/mL||Standard Error|Least Squares Mean
788767|NCT00851903|Secondary|Change in Body Weight From Baseline to Study Endpoint|Change = study endpoint - baseline|baseline, study endpoint: week 12 or week 8 or week 4 depending on last available value|The population analyzed was the safety population with both baseline and endpoint values available||kg||Standard Deviation|Mean
788768|NCT00851903|Secondary|Number of Patients With at Least One Episode of Symptomatic Hypoglycemia|Symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemia confirmed or not by a plasma glucose measurement <= 70mg/dL [3.9 mmol/L]|During the treatment period (12 weeks) plus 7 days after last dose|The population analyzed for this outcome measure was the safety population||participants|||Number
788769|NCT00851903|Secondary|Insulin Dose|Daily dose at the face-to-face visits|baseline, week 4, week 8, week 12|mITT population||unit per kg body weight||Standard Deviation|Mean
788770|NCT00851903|Secondary|7-point Plasma Glucose Profile: Change From Baseline to Study Endpoint|"7-point plasma glucose recorded before and after breakfast, before and after lunch, before and after dinner and at bedtime.
Change = study endpoint - baseline."|baseline, study endpoint: week 12 or week 8 if value not available at week 12|"The population analyzed consisted of the subset of mITT patients who had valid 7-point plasma glucose profiles (4 points needed for a valid profile) both at baseline and endpoint.
Depending on the time point, few values were missing."||mg/dL||Standard Deviation|Mean
788771|NCT00851903|Secondary|Self-Monitored Fasting Plasma Glucose (SMFPG) Mean : Change From Baseline to Study Endpoint|"SMFPG mean = mean of the fasting plasma glucose values recorded on the 6 consecutive days before the visit (at least 3 values needed).
Change = study endpoint - baseline."|baseline, study endpoint: week 12 or week 8 if value not available at week 12|The population analyzed consisted of the subset of mITT patients who had both baseline and endpoint for this outcome measure||mg/dL||Standard Deviation|Mean
788772|NCT00851903|Secondary|HbA1c: Change From Baseline to Study Endpoint|Change = study endpoint - baseline|baseline, study endpoint: week 12 or earlier in case of premature discontinuation|The population analyzed consisted of the subset of mITT patients who had both baseline and endpoint for this outcome measure||percent||Standard Deviation|Mean
788773|NCT00851903|Primary|HbA1c Response Rate: Percentage of Patients Achieving Glycosylated Haemoglobin A1c (HbA1c) < 7% at Study Endpoint (End of Treatment Period)||study endpoint: week 12 or earlier in case of premature discontinuation|The population analyzed consisted of the subset of mITT patients who had HbA1c value at study endpoint.||percentage of participants||95% Confidence Interval|Number
788774|NCT00852124|Primary|To Establish the Safety of VSL#3 in Adults Asthmatics|Change in FEV|3 months|3 people were randomized to this arm but no data were analyzed due to early termination of study|||||
788775|NCT00852137|Secondary|Max Composite Local Skin Response (LSR) Score|Max composite Local Skin Response (LSR) score on day 3 only . The treatment area was assessed at baseline and at each subsequent study visit for the presence and grade of the following Local Skin Responses (LSRs): erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration using the Local Skin Response Grading Scale (version 5). Each LSR was graded from 0 (best outcome) to 4 (worst outcome). A composite LSR score was calculated as the sum of each individual LSR grade, giving a possible range of 0–24. (One vehicle treated patent had a LSR on day 1 only).|Day 3|||local skin response score||Standard Deviation|Mean
788776|NCT00852137|Secondary|Patients With Incidence of Pigmentation and Scarring|Patients with Incidence of pigmentation and scarring, and grade of pigmentation and scarring, following study treatment through Day 57|Baseline, Day 2, 3, 8, 15, 29 and 57|||participants|||Number
788777|NCT00852137|Secondary|Number of Patients With Local Skin Responses (LSRs) Above 0 at Any Time Point During the Study.|Number of patients with LSR at any time point during the study above 0. The treatment area was assessed at baseline and at each subsequent study visit for the presence and grade of the following Local Skin Responses (LSRs): erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration using the Local Skin Response Grading Scale (version 5). Each LSR was graded from 0 (best outcome) to 4 (worst outcome). A composite LSR score was calculated as the sum of each individual LSR grade, giving a possible range of 0–24.|baseline and Day 2, 3, 8, 15, 29 and 57|||participants|||Number
788778|NCT00852137|Secondary|Percentage (%) Change in Actinic Keratosis (AK) Lesions in a 25 cm^2 Area Within the Selected Treatment Area|Percentage (%) change in actinic keratosis (AK) lesions count at Day 57, compared to baseline, in a 25 cm^2 area within the selected treatment area.|Baseline and Day 57|||change from baseline lesion count (%)||Standard Deviation|Mean
788779|NCT00852137|Secondary|Complete Clearance Rate in a 25 cm^2 Area Within the Selected Treatment Area|Number of participants with complete clearence. Complete clearance rate is defined as no clinically visible actinic keratosis (AK) lesions in a 25 cm^2 area within the selected treatment area at Day 57 compared to baseline|baseline and day 57|||participants|||Number
788780|NCT00852137|Primary|Area Under the Blood Conc. Versus Time Curve for Time 0–24 Hours (AUC(0-24)) for Ingenol Mebutate and Its Two Acyl Isomers (PEP015 and PEP025) Levels|Area under the blood conc. versus time curve was calculated for time 0–24 hours (AUC(0-24)) for ingenol mebutate and its two acyl isomers (PEP015 and PEP025) levels measured at 30 min, 1, 2, 4, 8, 12 and 24 hours following study medication application on Day 2.|1 day|||ng/mL x h||Standard Deviation|Mean
788781|NCT00852137|Primary|Time at Which Cmax is Attained (Tmax) for Ingenol Mebutate, and Its Two Acyl Isomers (PEP015 and PEP025) Levels.|Time at which Cmax is attained (Tmax) for ingenol mebutate, and its two acyl isomers (PEP015 and PEP025) levels measured at 30 min, 1, 2, 4, 8, 12 and 24 hours following study medication application on Day 2. If a maximum value occured at more than one timepoint Tmax is defined as the first timepoint with this value.|1 day|||hours|||Number
788782|NCT00852137|Primary|Maximum Observed Concentration (Cmax) for Ingenol Mebutate and Its Two Acyl Isomers (PEP015 and PEP025) Levels|Maximum observed concentration (Cmax) for ingenol mebutate and its two acyl isomers (PEP015 and PEP025) levels over the 24 hour sampling time period based on actual values measured. Blood samples were taken: at 30 minutes, 1, 2, 4, 8, 12 and 24 hours following study medication application on Day 2.|1 day|||ng/mL||Standard Deviation|Mean
788783|NCT00852397|Other Pre-specified|Percentage of Participants Who Had Thrombolysis in Myocardial Infarction (TIMI) Defined-individual Bleeding Endpoints (Minor or Minimal Bleeding) During the Treatment Period.|"TIMI minor bleeding event was defined as a clinically overt bleeding (including bleeding evident on imaging studies) associated with a >= 3 gm/dL fall in hemoglobin or a 9% fall in hematocrit from baseline, accounting for the effect of transfusions (1 unit packed red blood cells = 1 gm/dL hemoglobin = 3% hematocrit).
TIMI minimal bleeding event was defined as a clinically overt bleeding (including bleeding evident on imaging studies) not meeting criteria for TIMI minor bleeding."|Week 0 to Week 24|Bleeding endpoint was included in safety evaluations. The safety analysis set was defined as all treated participants (randomized participants who received at least one dose of study drug).||Percentage of Participants||95% Confidence Interval|Number
788784|NCT00852397|Other Pre-specified|Percentage of Participants Who Had International Society on Thrombosis and Haemostasis (ISTH)-Defined Individual Bleeding Endpoints (Clinically-relevant Non-major [CRNM] or Minor Bleeding) During the Treatment Period.|"ISTH-defined CRNM bleeding was defined as an acute or sub-acute clinically overt bleeding that did not satisfy the criteria for major bleeding and that led to either hospital admission for bleeding, physician guided medical or surgical treatment for bleeding or a change in antithrombotic therapy.
ISTH defined minor bleeding event was defined as all acute clinically overt bleeding events not meeting the criteria for either major bleeding or CRNM bleeding were classified as minor bleeding."|Week 0 to Week 24|Bleeding endpoint was included in safety evaluations. The safety analysis set was defined as all treated participants (randomized participants who received at least one dose of study drug).||Percentage of Participants||95% Confidence Interval|Number
788785|NCT00852397|Secondary|Percentage of Participants Who Had Composite of All-cause Death, Non-fatal Myocardial Infarction (MI), Unstable Angina, and Non-hemorrhagic Stroke Occurring During the Intended Treatment Period.|Intended treatment period for efficacy endpoints was defined as a period starting on the day of randomization and ending at the later date of either 2-days after the last dose of study drug or Day 168/Week 24 after randomization day (or the study termination date [19 November 2010, Japan time]).|From the day of randomization to the later date of either 2-days after the last dose of study drug or Day 168/Week 24 after randomization day (or the study termination date [19 November 2010, Japan time])|The efficacy analysis set was all randomized participants.||Percentage of Participants||95% Confidence Interval|Number
788786|NCT00852397|Secondary|Percentage of Participants Who Had Composite of All-cause Death, Non-fatal Myocardial Infarction, Unstable Angina and Stroke During 30 Days After Discontinuation of Therapy.||For 30 days after Week 24 or the discontinuation of study drug|Bleeding endpoint was included in safety evaluations. The safety analysis set was defined as all treated participants (randomized participants who received at least one dose of study drug).||Percentage of Participants||95% Confidence Interval|Number
788787|NCT00852397|Secondary|Percentage of Participants Who Had Thrombolysis in Myocardial Infarction (TIMI)-Defined Major Bleeding Occurring During the Treatment Period.|TIMI major bleeding event was difined as an intracranial bleeding or clinically overt bleeding (including bleeding evident on imaging studies) associated with a >= 5 gm/dL fall in hemoglobin or a 15% fall in hematocrit from baseline, accounting for the effect of transfusions (1 unit packed red blood cells = 1 gm/dL hemoglobin = 3% hematocrit).|Week 0 to Week 24|Bleeding endpoint was included in safety evaluations. The safety analysis set was defined as all treated participants (randomized participants who received at least one dose of study drug).||Percentage of Participants||95% Confidence Interval|Number
788788|NCT00852397|Secondary|Percentage of Participants Who Had Major Bleeding Occurring During the Treatment Period Per International Society on Thrombosis and Haemostasis (ISTH) Definitions.|Major bleeding event was defined as an acute clinically overt bleeding accompanied by decrease in hemoglobin of 2 g/dL or more over a 24-hour period, transfusion of 2 or more units of packed red blood cells, or bleeding that occured in critical site (e.g., intracranial). Fatal bleeding was also major bleeding event.|Week 0 to Week 24|Bleeding endpoint was included in safety evaluations. The safety analysis set was defined as all treated participants (randomized participants who received at least one dose of study drug).||Percentage of Participants||95% Confidence Interval|Number
788789|NCT00852397|Secondary|Percentage of Participants Who Had One or More All Bleeding Occurring During the Treatment Period.|All bleeding included major bleeding (including fatal bleeding), clinically-relevant non-major (CRNM) bleeding, and minor bleeding per international society on thrombosis and haemostasis (ISTH) definitions.|Week 0 to Week 24|Bleeding endpoint was included in safety evaluations. The safety analysis set was defined as all treated participants (randomized participants who received at least one dose of study drug).||Percentage of Participants||95% Confidence Interval|Number
788813|NCT00852761|Secondary|Dermatology Quality of Life - Personal Relationships|"Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions.
Sum of scores for questions 8 and 9. Score range from 0 to 6. A higher score denotes a more impaired quality of life"|Baseline, Days 3, 8, 15|ITT (Note: some subjects did not complete the survey at all timepoints; however, all data available was analyzed.)||units on a scale||Standard Deviation|Mean
788790|NCT00852397|Primary|Percentage of Participants Who Had Composite of International Society on Thrombosis and Haemostasis (ISTH)-Defined Major and Clinically-relevant Non-major (CRNM) Bleeding Events Occurring During the Treatment Period.|Major bleeding event was acute clinically overt bleeding accompanied by decrease in hemoglobin of 2 g/dL or more over a 24-hour period, transfusion of 2 or more units of packed red blood cells, or bleeding that occurs in critical site (e.g., intracranial). Fatal bleeding was also major bleeding event. CRNM bleeding was acute or sub-acute clinically overt bleeding that did not satisfy the criteria for major bleeding and that led to either hospital admission for bleeding, physician guided medical or surgical treatment for bleeding or a change in antithrombotic therapy.|Week 0 to Week 24|Bleeding endpoint was included in safety evaluations. The safety analysis set was defined as all treated participants (randomized participants who received at least one dose of study drug).||Percentage of Participants||95% Confidence Interval|Number
788791|NCT00852475|Secondary|Endothelium-dependent FMD Assessed by the Brachial Artery Reactivity Test (BART) at Rest .|Ultrasonographic imaging of the brachial artery (BART) was used to assess endothelium-dependent flow-mediated vasodilation (FMD) in participants at rest. To do this,the blood pressure cuff is inflated to 200 mm Hg and kept inflated for 5 minutes. On immediate release of the cuff, the brachial artery was imaged within 1 minute after cuff release.|6 months from Baseline|||percentage of change from baseline||Standard Error|Mean
788792|NCT00852475|Primary|Weight Changes in Veterans With MetS.||6 months from Baseline|||kg||Standard Error|Mean
788793|NCT00852527|Primary|Diagnostic Accuracy of the TBI Clinical Reminder Screen (TCRS)|Patients were initially assessed with the TBI Clinical Screen at their local VA. To assess the diagnostic accuracy of the TCRS, a dual-criterion approach was used. The VA Comprehensive TBI Evaluation (CTBIE), a secondary evaluation, served as the first criterion and the Structured TBI Diagnostic Interview (STDI) as the second criterion.|All OEF/OIF Veterans to receive TCRS upon enrollment in VA|Although 456 participants were consented and enrolled in the study, data for 13 participants had missing assessment data and another 5 were determined to have moderate TBI resulting in 438 cases for the analysis.||Percentage of participants||95% Confidence Interval|Number
788794|NCT00852540|Secondary|Mean Wound Size at Visits 1, 2, 3, 4, and 5|Lesion sized was measured in centimeters squared at Visits 1, 2, 3, 4, and 5.|Visits 1 (Day 1), 2 (Day 3-4), 3 (Day 7-9), 4 (Day 12-14), and 5 (Day 17-19)|ITTC Population. Only participants with non-missing data were included in this analysis. One par. was randomized to retapamulin but received linezolid. This par. is summarized in the linezolid group for all baseline and safety tables, but is summarized in the retapamulin group for all efficacy tables.||centimeters squared (cm^2)||Standard Deviation|Mean
788795|NCT00852540|Secondary|Mean Scores on the Skin Infection Rating Scale at Visits 1, 2, 3, 4, and 5|The investigator evaluated skin infections by grading the infected lesion for exudate (a fluid that leaks out of blood vessels into surrounding tissue)/pus, crusting, erythema (redness of the skin)/ inflammation (E/I), tissue warmth, tissue edema (swelling), itching, and pain, according to the Skin Infection Rating Scale. All parameters were graded on a scale of 0 (absent) to 6 (severe). The total score is calculated by summing the individual scores from the 7 parameters; the total score ranges from 0 to 42.|Visits 1 (Day 1), 2 (Day 3-4), 3 (Day 7-9), 4 (Day 12-14), and 5 (Day 17-19)|ITTC Population. Only participants with non-missing Skin Infection Rating Scale scores were included in this analysis. One par. was randomized to retapamulin but received linezolid. This par. is summarized in the linezolid group for all baseline and safety tables, but is summarized in the retapamulin group for all efficacy tables.||scores on a scale||Standard Deviation|Mean
788796|NCT00852540|Secondary|Number of Participants With Therapeutic Response at Follow-up|"Therapeutic response is defined as the combined clinical and microbiological response. Therapeutic response iss a measure of the overall efficacy response, and a therapeutic success refers to participants who had been deemed both a “clinical success” and a “microbiological success. All other combinations (other than “clinical success” + “microbiological success”) were deemed failures for therapeutic response."|7-9 days post-therapy; Day 12-14 for retapamulin and Day 17-19 for linezolid|ITTB Population||participants|||Number
788797|NCT00852540|Secondary|Number of Baseline Pathogens With the Indicated Microbiological Outcome at the End of Therapy|"Eradication is the elimination of BL pathogens. Presumed eradication and presumed improvement are clinical outcomes of success or improvement, respectively, such that no culture was obtained due to lack of culturable material, secondary to adequate clinical response, and is documented in the electronic Case Report Form. Persistence is defined as BL pathogens still being present. Presumed persistence is defined as a participant that is a clinical failure with no obtained culture. Unable to determine was used if no determination of BL pathogen microbiological response could be made."|2-4 days post-therapy; Day 7-9 for retapamulin and Day 12-14 for linezolid|ITTB Population||pathogens|||Number
788798|NCT00852540|Secondary|Number of Participants With the Indicated Clinical Outcome at the End of Therapy|"Clinical improvement is defined as improvement of signs/symptoms of infection recorded at baseline (BL) to such an extent that no further antimicrobial therapy is necessary. Clinical failure (CF) is defined as insufficient improvement/deterioration of signs/symptoms of the infection recorded at BL, such that additional antibiotic therapy is required. Unable to determine (UTD) is defined as refusal to consent to a clinical examination, lost to follow-up. Participants who are CF/Unable to Determine at end of therapy are considered such at follow-up as well."|2-4 days post-therapy; Day 7-9 for retapamulin and Day 12-14 for linezolid|ITTC Population. One par. was randomized to retapamulin but received linezolid. This par. is summarized in the linezolid group for all baseline and safety tables, but is summarized in the retapamulin group for all efficacy tables.||participants|||Number
788799|NCT00852540|Secondary|Number of Participants With the Indicated Microbiological Outcome at the End of Therapy Who Had MRSA as a Baseline (BL) Pathogen|"Eradication is the elimination of BL pathogens. Presumed eradication and presumed improvement are clinical outcomes of success or improvement, respectively, such that no culture was obtained due to lack of culturable material, secondary to adequate clinical response, and is documented in the electronic Case Report Form. Persistence is defined as BL pathogens still being present. Presumed persistence is defined as a participant that is a clinical failure with no obtained culture. Unable to determine was used if no determination of BL pathogen microbiological response could be made."|2-4 days post-therapy; Day 7-9 for retapamulin and Day 12-14 for linezolid|ITTMRSA Population||participants|||Number
788829|NCT00852917|Secondary|Dropout Rate|Reasons for withdrawal from the trial were collected|12 weeks|Safety population: all randomized patients who received at least one dose of the assigned study medication.||percentage of participants|||Number
788800|NCT00852540|Secondary|Number of Participants With the Indicated Clinical Outcome at the End of Therapy Who Had MRSA as a Baseline Pathogen|"Clinical improvement is defined as improvement of signs/symptoms of infection recorded at baseline (BL) to such an extent that no further antimicrobial therapy is necessary. Clinical failure (CF) is defined as insufficient improvement/deterioration of signs/symptoms of the infection recorded at BL, such that additional antibiotic therapy is required. Unable to determine (UTD) is defined as refusal to consent to a clinical examination, lost to follow-up. Participants who are CF/Unable to Determine at end of therapy are considered such at follow-up as well."|2-4 days post-therapy; Day 7-9 for retapamulin and Day 12-14 for linezolid|ITTMRSA Population||participants|||Number
788801|NCT00852540|Secondary|Number of Participants Who Achieved Microbiological Response (MR) at Follow-up (FU) Who Had a Baseline Pathogen (BP)|MR was defined as microbiological success if, (1) for participants (par.) whose clinical outcome at end of therapy (EOT) was “clinical success (CS)/improvement,” the BP was eradicated/presumed to be eradicated at EOT, or the BP was present at EOT and absent at FU, or the BP was eradicated/presumed to be eradicated at EOT, or the BP was present at EOT and par. was a “CS” such that no culture was obtained due to lack of culturable material secondary to adequate clinical response; or (2) a pathogen not previously identified at baseline was isolated at FU in a par. identified at FU as a “CS.”|7-9 days post-therapy; Day 12-14 for retapamulin and Day 17-19 for linezolid|Intent-to-Treat Bacteriology (ITTB) Population: all randomized participants who took at least one dose of study medication and who had a pathogen isolated at baseline.||participants|||Number
788802|NCT00852540|Secondary|Number of Participants With Clinical Response at Follow-up|"Follow-up is defined as 7-9 days post-therapy: Day 12-14 for retapamulin; Day 17-19 for linezolid. Clinical success at follow-up was defined as the resolution of clinically meaningful signs and symptoms of infection recorded at baseline, including a pus/exudate skin infection rating scale (SIRS) score of 0. The SIRS is used by the investigator to evaluate infected lesions. Scores on the SIRS range from 0 (absent) to 6 (severe)."|7-9 days post-therapy; Day 12-14 for retapamulin and Day 17-19 for linezolid|Intent-to-Treat Clinical (ITTC) Population: all randomized participants (par.) who took at least one dose of study medication. One par. was randomized to retapamulin but received linezolid. This par. is summarized in the linezolid group for all baseline and safety tables, but is summarized in the retapamulin group for all efficacy tables.||participants|||Number
788803|NCT00852540|Secondary|Number of Participants Achieving Microbiological Response (MR) at Follow-up (FU) Who Had MRSA as a Baseline Pathogen (BP)|MR was defined as microbiological success if, (1) for participants (par.) whose clinical outcome at end of therapy (EOT) was “clinical success (CS)/improvement,” the BP was eradicated/presumed to be eradicated at EOT, or the BP was present at EOT and absent at FU, or the BP was eradicated/presumed to be eradicated at EOT, or the BP was present at EOT and par. was a “CS” such that no culture was obtained due to lack of culturable material secondary to adequate clinical response; or (2) a pathogen not previously identified at baseline was isolated at FU in a par. identified at FU as a “CS.”|7-9 days post-therapy; Day 12-14 for retapamulin and Day 17-19 for linezolid|Intent-to-Treat MRSA (ITTMRSA) Population: all randomized participants who took at least one dose of study medication and who had an MRSA isolated at baseline.||participants|||Number
788804|NCT00852540|Primary|Number of Participants Achieving Clinical Response at Follow-up Who Had Methicillin-resistant Staphlococcus Aureus (MRSA) as a Baseline Pathogen|"Follow-up is defined as 7-9 days post-therapy: Day 12-14 for retapamulin; Day 17-19 for linezolid. Clinical success at follow-up was defined as the resolution of clinically meaningful signs and symptoms of infection recorded at baseline, including a pus/exudate skin infection rating scale (SIRS) score of 0. The SIRS is used by the investigator to evaluate infected lesions. Scores on the SIRS range from 0 (absent) to 6 (severe)."|7-9 days post-therapy; Day 12-14 for retapamulin and Day 17-19 for linezolid|Intent-to-Treat MRSA (ITTMRSA) Population: all randomized participants who took at least one dose of study medication and who had an MRSA isolated at baseline.||participants|||Number
788805|NCT00852592|Secondary|Global Assessment of Functioning (GAF)|The GAF is used to assess global psychosocial functioning. Scores range from 0-100 with higher values representing higher functioning and better outcome.|6-weeks|||units on a scale||Standard Deviation|Mean
788806|NCT00852592|Primary|SIGH-ADS Depression Score|The Structured Interview Guide for the Hamilton Depression Rating Scale-HRS-D with Atypical Depression Supplement (SIGH-ADS) provides a benchmark for depression severity; SIGH-ADS scores range from 0-79; higher values represent increased depression severity and worse outcome.|6 weeks|||units on a scale||Standard Deviation|Mean
788807|NCT00852631|Secondary|Clinical Global Impression - Severity of Illness (CGI-S) Score|Clinical Global Impression - Severity of Illness. Maximum possible value is 7 (worst outcome), the minimum is 1 (best outcome). Values are considered better outcome: decrease from baseline > 1 score.|Day 14|The number of patient is different, because some of them withdraw/terminate during the study.||Scores on a scale||Standard Deviation|Mean
788808|NCT00852631|Primary|Change in Positive and Negative Syndrome Scale (PANSS) Total Score|"Change in Positive and Negative Syndrome Scale Total Score from Day 1 (baseline) to Day 42 (final visit) or withdrawal. Minimum value of total PANSS is 30 , Maximum is 210.
Minimum value considered better is score decreased from baseline at least 30%."|From Day 1 (baseline) to Day 42|The number of patient at Day 42 (n= 17) is different than at Baseline (n= 28), because some of them withdraw/terminate during the study.||Scores on a scale||Standard Deviation|Mean
788809|NCT00852631|Secondary|Change in Clinical Global Impression - Severity of Illness (CGI-S) Score|Clinical Global Impression - Severity of Illness. Maximum possible value is 7 (worst outcome), the minimum is 1 (best outcome). Values are considered better outcome: decrease from baseline > 1 score.|From Day 1 (Baseline) to Day 42|The number of patient at Day 42 (n= 17) is different than at Baseline (n= 28), because some of them withdraw/terminate during the study.||Scores on a scale||Standard Deviation|Mean
788810|NCT00852761|Secondary|Dermatology Life Quality Index (DLQI) Categories|Number of participants who indicated one of the following for total DLQI: 0-1 No effect on the patient's life; 2-5 Small effect on the patient's life; 6-10 Moderate effect on the patient's life; 11-20 Very large effect on the patient's life.|Days 3, 8, 15|||participants|||Number
788811|NCT00852761|Secondary|Total Dermatology Life Quality Index (DLQI) Score|"Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions.
Sum of scores for all questions. Score range from 0 to 30. A higher score denotes a more impaired quality of life"|Baseline, Days 3, 8, 15|ITT (Note: some subjects did not complete the survey at all timepoints; however, all data available was analyzed.)||units on a scale||Standard Deviation|Mean
788814|NCT00852761|Secondary|Dermatology Quality of Life - Work and School|"Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions.
Sum of scores for questions 7. Score range from 0 to 3. A higher score denotes a more impaired quality of life"|Baseline, Days 3, 8, 15|ITT (Note: some subjects did not complete the survey at all timepoints; however, all data available was analyzed.)||units on a scale||Standard Deviation|Mean
788815|NCT00852761|Secondary|Dermatology Quality of Life - Leisure|"Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions.
Sum of scores for questions 5 and 6. Score range from 0 to 6. A higher score denotes a more impaired quality of life"|Baseline, Days 3, 8, 15|ITT (Note: some subjects did not complete the survey at all timepoints; however, all data available was analyzed.)||units on a scale||Standard Deviation|Mean
788816|NCT00852761|Secondary|Dermatology Quality of Life - Daily Activities|"Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions.
Sum of scores for questions 3 and 4. Score range from 0 to 6. A higher score denotes a more impaired quality of life"|Baseline, Days 3, 8, 15|ITT (Note: some subjects did not complete the survey at all timepoints; however, all data available was analyzed.)||units on a scale||Standard Deviation|Mean
788817|NCT00852761|Secondary|Dermatology Quality of Life - Symptoms and Feelings|"Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions.
Sum of scores for questions 1 and 2. Score range from 0 to 6. A higher score denotes a more impaired quality of life"|Baseline, Days 3, 8, 15|ITT (Note: some subjects did not complete the survey at all timepoints; however, all data available was analyzed.)||units on a scale||Standard Deviation|Mean
788818|NCT00852761|Secondary|Median Change in Psoriasis Grading Scale|Median improvement in elbow and/or knee lesion using the Psoriasis Grading Scale for Target Lesion Score: 0 = No evidence of scaling, erythema, or elevation. 1 = Minimal; occasional scale, faint erythema, slight elevation. 2 = Mild; fine scales, light red color, slight elevation. 3 = Moderate; coarse scales, moderate red coloration and elevation . 4 = Marked; thick scale, bright red coloration, marked elevation. 5 = Severe; very thick tenacious scale predominates, dusky to deep red coloration, very marked elevation.|Baseline, Days 3, 8, 15|ITT||unites on a scale||Inter-Quartile Range|Median
788819|NCT00852761|Secondary|At Least a 3 Grade Improvement in Subject's Global Assessment|Number of participants who achieve treatment success (minimum three grade improvement or more) in their elbow and/or knee target lesion as defined by the Subject's Global Assessment. 0 = My skin is completely clear, except for residual hyperpigmentation. 1 = My psoriasis is almost clear; patchy fine scaling may be present. 2 = My psoriasis is mild, with a small amount of psoriasis. 3 = My psoriasis is moderate, between slight and definitely noticeable. 4 = My psoriasis is very noticeable. 5 = My psoriasis is severe with severe redness, thick scaling, plaques.|Baseline, days 3, 8, 15|Intent to treat (ITT)||participants|||Number
788820|NCT00852761|Secondary|At Least a 2 Grade Improvement in Subject's Global Assessment|Number of participants who achieve treatment success (minimum two grade improvement or more) in their elbow and/or knee target lesion as defined by the Subject's Global Assessment. 0 = My skin is completely clear, except for residual hyperpigmentation. 1 = My psoriasis is almost clear; patchy fine scaling may be present. 2 = My psoriasis is mild, with a small amount of psoriasis. 3 = My psoriasis is moderate, between slight and definitely noticeable. 4 = My psoriasis is very noticeable. 5 = My psoriasis is severe with severe redness, thick scaling, plaques.|Baseline, days 3, 8, 15|Intent to treat (ITT)||participants|||Number
788821|NCT00852761|Secondary|At Least 1 Grade Improvement in Subject’s Global Assessment|Number of participants who achieve treatment success (minimum one grade improvement or more) in their elbow and/or knee target lesion as defined by the Subject’s Global Assessment. 0 = My skin is completely clear, except for residual hyperpigmentation. 1 = My psoriasis is almost clear; patchy fine scaling may be present. 2 = My psoriasis is mild, with a small amount of psoriasis. 3 = My psoriasis is moderate, between slight and definitely noticeable. 4 = My psoriasis is very noticeable. 5 = My psoriasis is severe with severe redness, thick scaling, plaques.|Baseline, days 3, 8, 15|Intent to treat (ITT)||participants|||Number
788822|NCT00852761|Secondary|At Least a 3 Grade Improvement in the Psoriasis Global Assessment|Number of participants who acheive at least a 3 grade improvement in the Psoriasis Global Assessment. 0 = Clear; 1 = Almost Clear; 2 = Mild; 3 = Moderate; 4 = Severe.|Baseline, days 3, 8, 15|Intent to treat (ITT)||participants|||Number
788823|NCT00852761|Secondary|At Least a 2 Grade Improvement in the Psoriasis Global Assessment|Number of participants who acheive at least a 2 grade improvement in the Psoriasis Global Assessment. 0 = Clear; 1 = Almost Clear; 2 = Mild; 3 = Moderate; 4 = Severe.|Baseline, days 3, 8, 15|Intent to treat (ITT)||participants|||Number
788824|NCT00852761|Secondary|At Least 1 Grade Improvement in the Psoriasis Global Assessment|Number of participants who acheive at least a 1 grade improvement in the Psoriasis Global Assessment. 0 = Clear; 1 = Almost Clear; 2 = Mild; 3 = Moderate; 4 = Severe.|Baseline, days 3, 8, 15|Intent to treat (ITT)||participants|||Number
788825|NCT00852761|Secondary|At Least a 3 Grade Improvement Psoriasis Grading Scale|"Number of participants who achieve a minimum of three grade improvement or more in their elbow and/or knee target lesion as defined by the Psoriasis Grading Scale for Target Lesion.
The scale is the same as used for the primary outcome (0 through 5)."|Baseline, days 3, 8, 15|Intent to treat (ITT)||participants|||Number
788826|NCT00852761|Secondary|At Least a 2 Grade Improvement Psoriasis Grading Scale|"Number of participants who achieve a minimum two grade improvement or more in their elbow and/or knee target lesion as defined by the Psoriasis Grading Scale for Target Lesion.
The scale is the same as used for the primary outcome (0 through 5)."|Baseline, days 3, 8, 15|Intent to treat (ITT)||participants|||Number
788827|NCT00852761|Secondary|At Least 1 Grade Improvement Psoriasis Grading Scale|"Number of participants who achieve a minimum one grade improvement or more in their elbow and/or knee target lesion as defined by the Psoriasis Grading Scale for Target Lesion.
The scale is the same as used for the primary outcome (0 through 5)."|Baseline, days 3 and 8|Intent to treat (ITT)||participants|||Number
788828|NCT00852761|Primary|At Least a One Grade Improvement for the Target Psoriasis Lesion on the Elbow or Knee (Psoriasis Grading Scale)|Number of participants who achieved a minimum 1-grade improvement in elbow and/or knee lesion using the Psoriasis Grading Scale for Target Lesion Score: 0 = No evidence of scaling, erythema, or elevation. 1 = Minimal; occasional scale, faint erythema, slight elevation. 2 = Mild; fine scales, light red color, slight elevation. 3 = Moderate; coarse scales, moderate red coloration and elevation . 4 = Marked; thick scale, bright red coloration, marked elevation. 5 = Severe; very thick tenacious scale predominates, dusky to deep red coloration, very marked elevation.|Baseline to day 15|ITT||participants|||Number
788830|NCT00852917|Primary|Percentage Difference Between WOMAC Physical Function Subscale Score From Baseline to the End of the Study (Week 12)|Percentage of difference in WOMAC Physical Function Subscale score between baseline and week 12. The WOMAC scale is a 24-item questionnaire divided in 3 subscales, using a 100mm visual analog scale ranging from no difficulty (0mm) to extreme difficulty (100mm). The WOMAC Physical Function subscale results from the sum of 17 of the questions.|12 weeks|The analysis was performed using the full analysis population (All randomized patients who received at least one dose of the assigned study medication and had at least one post Baseline assessment of any functional scale). Missing Values at Last Visit Imputed by Individual Last Post Baseline Value.||Percentage difference in WOMAC Physical||Standard Deviation|Mean
788831|NCT00852917|Secondary|Investigator Global Rating of Pain Relief|"The Investigator Global Rating of Pain is a 3-item Likert-scale to answer the following question: How do you rate this patient’s overall pain relief with the drug? with 3 possible answers: very effective, effective, or ineffective."|12 weeks|The analysis was performed using the full analysis population (All randomized patients who received at least one dose of the assigned study medication and had at least one post Baseline assessment of any functional scale)||participants|||Number
788832|NCT00852917|Secondary|Multiple Dose Effect Using 24-hour VAS Pain Questionnaire|Patients rated their knee pain by marking a 100mm Visual Analogue Scale, ranging from no pain (0mm) to extreme pain (100mm).|12 weeks|The analysis was performed using the full analysis population (All randomized patients who received at least one dose of the assigned study medication and had at least one post Baseline assessment of any functional scale). Missing Values at Last Visit Imputed by Individual Last Post Baseline Value.||mm||Standard Deviation|Mean
788833|NCT00852917|Secondary|Percentage Change in WOMAC Physical Function Subscale Score From Baseline to Intervening Visits (Visits 2-4)|Percentage of difference in WOMAC Physical Function Subscale score between baseline and intervening visits 2-4. The WOMAC scale is a 24-item questionnaire divided in 3 subscales. The WOMAC Physical Function Subscale comprises 17 questions each rated on a 100mm visual analog scale (VAS) ranging from no difficulty (0mm) to extreme difficulty (100mm).|Week 0, week 3, week 6|The analysis was performed using the full analysis population (All randomized patients who received at least one dose of the assigned study medication and had at least one post Baseline assessment of any functional scale)||Percentage difference in WOMAC Physical||Standard Deviation|Mean
788834|NCT00852917|Secondary|Percentage Change in WOMAC Pain Subscale Score From Baseline to Intervening Visits (Visits 2-4)|Percentage of difference in WOMAC Pain Subscale score between baseline and intervening visits 2-4. The WOMAC scale is a 24-item questionnaire divided in 3 subscales, using a 100mm visual analog scale ranging from no pain (0mm) to extreme pain (100mm). The WOMAC Pain Subscale results from the sum of 5 questions.|Week 0, week 3, week 6|The analysis was performed using the full analysis population (All randomized patients who received at least one dose of the assigned study medication and had at least one post Baseline assessment of any functional scale)||Percentage difference in WOMAC Pain||Standard Deviation|Mean
788835|NCT00852917|Primary|Percentage Difference Between WOMAC Pain Subscale Score From Baseline to the End of the Study (Week 12)|Percentage of difference in WOMAC Pain Subscale score between baseline and week 12. The WOMAC scale is a 24-item questionnaire divided in 3 subscales, using a 100mm visual analog scale (VAS) ranging from no pain (0mm) to extreme pain (100mm). The WOMAC Pain Subscale results from the sum of 5 of the questions.|12 weeks|The analysis was performed using the full analysis population (All randomized patients who received at least one dose of the assigned study medication and had at least one post Baseline assessment of any functional scale). Missing Values at Last Visit Imputed by Individual Last Post Baseline Value.||Percentage difference in WOMAC Pain||Standard Deviation|Mean
788836|NCT00852917|Primary|Patient Global Rating of Pain for the Study Period (12 Weeks)|"3-item Likert-scale: How do you rate overall pain relief with the drug? with 3 possible answers: very effective, effective, or ineffective. The average of ratings at visits 2-5 was calculated as median, rounded up to the closest integer."|12 weeks|The analysis was performed using the full analysis population (All randomized patients who received at least one dose of the assigned study medication and had at least one post Baseline assessment of any functional scale)||participants|||Number
788837|NCT00852930|Primary|Whole Arm Volume Difference|Whole arm measurement to determine volume.|Baseline and on last day of treatment with average number of treatments being 9 conducted over a median of up to 4 weeks.|||Whole Arm Volume % Difference||Inter-Quartile Range|Median
788838|NCT00852930|Secondary|Quality of Life|The Functional Assessment of Chronic Illness Therapy that measure quality of life -total score. Range of scores could be 0 to 148. Higher score represents higher quality of life.|Self-report on last day of treatment with average number of treatments being 9 conducted over a median of up to 4 weeks.|||total score||Inter-Quartile Range|Median
788839|NCT00852930|Secondary|Symptoms|Yes/no response to a symptom listed on the Lymphedema Symptom Intensity and Distress Scale-Arm (LSIDS-A) self-report form.|Self report on last day of treatment with average treatments being 9 conducted over a median of up to 4 weeks.|Total number of reported symptoms. Range of symptoms reported could be 0 to 36. Greater number of symptoms represents worse outcome.||symptoms||Inter-Quartile Range|Median
788840|NCT00852930|Primary|LDex Change-|Bioimpedance measured by units of LDex. As extracellular fluid accumulates (i.e. lymphedema develops) the LDex value increases.|Bioimpedance at baseline and end of treatment with the average number of treaments being 9 conducted over a median of up to 4 weeks.|LDex units.||LDex||Inter-Quartile Range|Median
788841|NCT00852969|Secondary|Change in HDL-C From Baseline to 14 Weeks||14 weeks since baseline|||mg/dl||95% Confidence Interval|Mean
788842|NCT00852969|Primary|Change in the Flow Mediated Dilation From Baseline|Flow mediated dilation by brachial artery reactivity at baseline versus 14 weeks|14 weeks since baseline|||absolute percent change||95% Confidence Interval|Mean
788843|NCT00852995|Secondary|Median Time to Achieve Complete Wound Closure, Based on Based on a Kaplan-Meier Survival Analysis, Over the 12-Week Treatment Period From Baseline.|This key secondary outcome was the days to wound closure based on a Kaplan-Meier survival analysis.|14 weeks – the final visit for one subject was delayed by two weeks|ITT Populations: Subjects who received at least one dose of test article. Data were analyzed using the Kaplan-Meier survival procedure, with significance being at P < 0.05.||Days to Closure||95% Confidence Interval|Median
789192|NCT00861705|Secondary|Time to First Failure, Defined as First Instance of Ipsilateral Invasive Breast Tumor Recurrence, Local/Regional Invasive Breast Cancer Recurrence, Distant Recurrence, or Death From Any Cause|From study entry to first event.|up to 10 years||10/2018||||
788844|NCT00852995|Secondary|Target Ulcer Pain Was Measured Using a Visual Analog Scale [Range: 0mm – 100mm]. Subjects Marked Their Pain Level on a 100 mm Horizontal Line, With a Short Vertical Line Across the Scale, 0 Denoting no Pain and 100mm the Maximum Pain.|Target ulcer pain was measured using a Visual Analog Scale [Range: 0mm – 100mm]. Subjects marked their pain level on a 100 mm horizontal line, with a short vertical line across the scale, 0 denoting no pain and 100mm the maximum pain. Each weekly measurement is reported as the average of all subjects scores at each week per treatment group.|Weekly, over the 12 week treatment period|ITT Populations: Subjects who received at least one dose of test article. Data were analyzed by an ANCOVA, adjusted for site and baseline score.||units on a scale||Standard Deviation|Mean
788845|NCT00852995|Secondary|Percentage of Participants With Complete Wound Closure at Each Visit|Treatment groups were compared for the proportion of wounds closed at each weekly visit. For subjects who dropped from the study, their remaining visit values were imputed using LOCF.|Weekly, over the 12 week treatment period|ITT Populations: Subjects who received at least one dose of test article. Analysis was by the Cochrane Mantel Haenszel (CMH) test||percentage of participants|||Number
788846|NCT00852995|Secondary|Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13|The area of each subject’s target wound was measured at each visit and the proportion of subjects with a decrease in area from baseline ≥ 50% was calculated for each treatment group.|Over the 12 week treatment period or until the wound closed, which ever occurred first.|The non-parametric Cochrane Mantel Haenszel test with adjustment for pooled site was used to examine treatment effects at each time point on the proportion of responders who have an average of ≥50% reduction from baseline in wound area over the treatment period. The test was performed separately for each pair of an active treatment vs. placebo.||Responders|||Number
788847|NCT00852995|Secondary|Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks.|For each treatment group the area of each subject’s target ulcer was measured on a weekly basis, for up to 12 weeks, using a laser-based wound imaging system in conjunction with software to measure area.|Weekly, over the 12 week treatment period, or until wound closure, which ever occurred first|ITT population. Subjects who received at least one dose of test article. The data at each week were analyzed using a two-way ANCOVA model, which included treatment group (the effect of interest), site, and the baseline target wound area (the covariate). Significance was attained at P < 0.05.||Percent change||Standard Error|Least Squares Mean
788848|NCT00852995|Secondary|Kaplan-Meier Probability of Non-Closure|This key secondary outcome was the days to wound closure based on a Kaplan-Meier survival analysis.|14 weeks – the final visit for one subject was delayed by two weeks|ITT Populations: Subjects who received at least one dose of test article. Data were analyzed using the Kaplan-Meier survival procedure, with significance being at P < 0.05.||Probability of Non-Closure|||Number
788849|NCT00852995|Primary|The Average Percent (%) Change From Baseline in the Target Wound Area in Each Treatment Group Over the Twelve-week Double-blind Treatment Period.|For each treatment group the area of each subject’s target ulcer was measured on a weekly basis, for up to 12 weeks, or until wound closure, whichever occurred first, using a laser-based wound imaging system in conjunction with software to measure area. An average of the 12 measurements were assessed.|Weekly, over the 12 week treatment period, or until wound closure, which ever occurred first|ITT population.: Subjects who received at least one dose of test article. The primary analysis was performed using a two-way ANCOVA model, which included treatment group (the effect of interest), site, and the baseline target wound area (the covariate), with significance being at P < 0.05.||percent change||Standard Deviation|Mean
788850|NCT00853021|Other Pre-specified|T-helper Cells (Type 1,2)|Peripheral blood mononuclear cells (PBMC) and plasma were separated by centrifugation. Targeted cells were isolated by a magnetic labeling system. Total RNA was isolated and then amplified by (Polymerase Chain Reactions) PCR to measure levels of the immune parameter.|Baseline (day -14), beginning and end of cycle 1 (day 1, 57)||||||
788851|NCT00853021|Other Pre-specified|CD25+ Treg Cells|Peripheral blood mononuclear cells (PBMC) and plasma were separated by centrifugation. Targeted cells were isolated by a magnetic labeling system. Total RNA was isolated and then amplified by (Polymerase Chain Reactions) PCR to measure levels of the immune parameter.|Baseline (day -14), beginning and end of cycle 1 (day 1, 57)||||||
788852|NCT00853021|Other Pre-specified|CD4+ Treg Cells|Peripheral blood mononuclear cells (PBMC) and plasma were separated by centrifugation. Targeted cells were isolated by a magnetic labeling system. Total RNA was isolated and then amplified by (Polymerase Chain Reactions) PCR to measure levels of the immune parameter.|Baseline (day -14), beginning and end of cycle 1 (day 1, 57)||||||
788853|NCT00853021|Other Pre-specified|IL-8 Levels|Peripheral blood mononuclear cells (PBMC) and plasma were separated by centrifugation. Targeted cells were isolated by a magnetic labeling system. Total RNA was isolated and then amplified by (Polymerase Chain Reactions) PCR to measure levels of the immune parameter.|Baseline (day -14), beginning and end of cycle 1 (day 1, 57)||||||
788854|NCT00853021|Other Pre-specified|CD303+ Plasmacytoid Dendritic Cells|Peripheral blood mononuclear cells (PBMC) and plasma were separated by centrifugation. Targeted cells were isolated by a magnetic labeling system. Total RNA was isolated and then amplified by (Polymerase Chain Reactions) PCR to measure levels of the immune parameter.|Baseline (day -14), beginning and end of cycle 1 (day 1, 57)||||||
788855|NCT00853021|Other Pre-specified|Peripheral Blood CD1c+ Myeloid Dendritic Cells|Peripheral blood mononuclear cells (PBMC) and plasma were separated by centrifugation. Targeted cells were isolated by a magnetic labeling system. Total RNA was isolated and then amplified by (Polymerase Chain Reactions) PCR to measure levels of the immune parameter.|Baseline (day -14), Beginning and end of cycle 1 (day 1, 57)||||||
788856|NCT00853021|Secondary|Percentage of Patients With Neutropenia|Toxicity Criteria: The NCI graded common clinical toxicity scale (NCI Version 2.0) will be employed to grade observed toxicity of neutropenia|From start of treatment to 30 days after treatment|||percentage of participants|||Number
788857|NCT00853021|Secondary|Percentage of Patients With Constitutional Adverse Events|Toxicity Criteria: The NCI graded common clinical toxicity scale (NCI Version 2.0) will be employed to grade observed toxicity of fatigue and fever/chills|From start of treatment to 30 days after treatment|||percentage of patients|||Number
788858|NCT00853021|Secondary|Objective Response Rate (Complete and Partial Response)|To be assigned a status of PR or CR, changes in tumor measurements must be confirmed by repeat assessments that should be performed no less than 4 weeks after the criteria for response are first met.|4 weeks after treatment|||percentage of participants|||Number
788859|NCT00853021|Primary|Progression Free Survival|Progression free survival is defined as the time between registration and progression of disease as defined by the RECIST criteria where there is a 20% increase in the diameter of the tumor and at least a 5mm absolute increase in diameter.|From baseline (day -14) to disease progression (reported at 2 years)|||months||95% Confidence Interval|Median
788860|NCT00853073|Secondary|Improvement in Filtering Blebs Morphology||6 months||||||
788861|NCT00853073|Primary|Intraocular Pressure (IOP)|mmHg (milimeters of mercury)|6 months|||mmHg (milimeters of mercury)||Full Range|Mean
788862|NCT00853099|Secondary|Number of Participants With Adverse Events During the Adalimumab Treatment Period|"An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related.
A serious adverse event is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.
For more details on adverse events please see the Adverse Event section below."|221 weeks|The safety analysis set.||participants|||Number
788863|NCT00853099|Secondary|Number of Participants With Adverse Events up to Week 52|"An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related.
A serious adverse event is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.
For more details on adverse events please see the Adverse Event section below."|52 weeks|The safety analysis set.||participants|||Number
788864|NCT00853099|Secondary|Number of Participants With Adverse Events up to Week 8|"An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related.
A serious adverse event is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.
For more details on adverse events please see the Adverse Event section below."|8 weeks|The Safety Analysis Set includes all participants who received at least one dose of study medication.||participants|||Number
788865|NCT00853099|Secondary|Percentage of Inflammatory Bowel Disease Questionnaire (IBDQ) Responders|An inflammatory bowel disease questionnaire responder was defined as a participant with at least a 16-point increase from Baseline in total Inflammatory Bowel Disease Questionnaire (IBDQ) score. The IBDQ is a 32-item questionnaire consisting of 4 dimensions: bowel-related symptoms, systemic function, social function, and emotional status. The responses to each question within each domain range from 1 (significant impairment) to 7 (no impairment), with the total score ranging from 32 (very poor) to 224 (perfect health-related quality of life).|Baseline and Weeks 8, 32, and 52|Full analysis set, non-responder imputation was used.||percentage of participants|||Number
788866|NCT00853099|Secondary|Percentage of Participants With Stool Frequency Subscore Indicative of Mild Disease (≤ 1)|"Stool frequency was assessed from the participant's diary, taking the worst score from the 3 days prior to each study visit. The stool frequency subscore ranges from zero to three, according to the following scale:
0 = Normal number of stools for this participant, 1 = 1-2 stools more than normal, 2 = 3-4 stools more than normal, 3 = 5 or more stools more than normal."|Weeks 8, 32, and 52|Full analysis set, non-responder imputation was used.||percentage of participants|||Number
788867|NCT00853099|Secondary|Percentage of Participants With Physician's Global Assessment Subscore Indicative of Mild Disease (≤ 1)|"The Physician's Global Assessment Subscore acknowledges the three other subscores (Stool Frequency, Rectal Bleeding, and Endoscopy), the participant's daily record of abdominal discomfort and functional assessment, and other observations such as physical findings and the participant's performance status. Possible scores range from zero to three as follows:
0 = Normal (other subscores are 0), 1 = Mild disease (other subscores are mostly 1), 2 = Moderate disease (other subscores are 1 to 2), 3 = Severe disease (other subscores are 2 to 3)."|Weeks 8, 32, and 52|Full analysis set, non-responder imputation was used.||percentage of participants|||Number
788868|NCT00853099|Secondary|Percentage of Participants With Rectal Bleeding Subscore Indicative of Mild Disease (≤ 1)|"Rectal bleeding was assessed from the participant's diary, taking the worst score from the 3 days prior to each study visit. The rectal bleeding subscore ranges from zero to three, according to the following scale:
0 = no blood seen, 1 = streaks of blood with stool less than half the time, 2 = obvious blood with stool most of the time, 3 = blood alone passed."|Weeks 8, 32, and 52|Full analysis set, non-responder imputation was used.||percentage of participants|||Number
788869|NCT00853099|Secondary|Percentage of Participants With Mucosal Healing|"Mucosal healing was defined as an endoscopy subscore of ≤ 1 and was assessed using flexible sigmoidoscopy performed at Weeks 8, 32, and 52.
The endoscopy subscore ranges from zero to three as follows:
0 = Normal or inactive disease, 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 2 = Moderate disease (marked erythema, absent vascular pattern, friability, erosions), 3 = Severe disease (spontaneous bleeding, ulceration)."|Weeks 8, 32, and 52|Full analysis set, non-responder imputation was used.||percentage of participants|||Number
788920|NCT00853242|Primary|Change From Baseline in Serum Phosphorus at Day 22 (Genz-644470 vs Placebo)||Baseline, Day 22|Full Analysis Set (FAS) included all participants who received at least one dose of study drug and had baseline and at least one post-baseline phosphorus measure less than or equal to (<=) 3 days after date of last study drug.||mg/dL||Standard Deviation|Mean
788870|NCT00853099|Secondary|Percentage of Participants With a Clinical Response|"A clinical response was defined as a decrease in Mayo score of ≥ 3 points and ≥ 30% from Baseline PLUS a decrease in the Rectal Bleeding Subscore (RBS) ≥ 1 or an absolute RBS of 0 or 1.
The Mayo score is a composite score of ulcerative colitis disease activity calculated as the sum of four subscores:
Stool Frequency Subscore, based on the participant's diary and scored from zero (normal number of stools) to three (5 or more stools than normal);
Rectal Bleeding Subscore, based on the participant's diary and scored from zero (no blood) to three (blood only passed);
Endoscopy Subscore, based on colonoscopy or sigmoidoscopy and scored from zero (normal or inactive disease) to three (severe disease, spontaneous bleeding, ulceration);
Physician's Global Assessment subscore, based on the physician's overall assessment, and scored from zero (normal) to three (severe disease).
The total Mayo score ranges from 0 to 12 points, with higher scores representing more severe disease."|Baseline and Weeks 8, 32, and 52|Full analysis set, non-responder imputation was used.||percentage of participants|||Number
788871|NCT00853099|Secondary|Percentage of Participants With Clinical Remission at 8, 32, and 52 Weeks|"Clinical remission was defined as a Mayo score ≤ 2 with no individual subscore > 1. The Mayo score is a composite score of ulcerative colitis disease activity calculated as the sum of four subscores:
Stool Frequency Subscore (SFS), based on the participant's diary and scored from zero (normal number of stools) to three (5 or more stools than normal);
Rectal Bleeding Subscore (RBS), based on the participant's diary and scored from zero (no blood) to three (blood only passed);
Endoscopy Subscore (ESS), based on colonoscopy or sigmoidoscopy and scores from zero (normal or inactive disease) to three (severe disease, spontaneous bleeding, ulceration);
Physician's Global Assessment (PGA) subscore, based on the physician's overall assessment, and scored from zero (normal) to three (severe disease).
The total Mayo score ranges from 0 to 12 points, with higher scores representing more severe disease."|Weeks 8, 32, and 52|Full analysis set, non-responder imputation was used.||percentage of participants|||Number
788872|NCT00853099|Primary|Percentage of Participants With Clinical Remission at 52 Weeks|"Clinical remission was defined as a Mayo score ≤ 2 with no individual subscore > 1. The Mayo score is a composite score of ulcerative colitis disease activity calculated as the sum of four subscores:
Stool Frequency Subscore (SFS), based on the participant's diary and scored from zero (normal number of stools) to three (5 or more stools than normal);
Rectal Bleeding Subscore (RBS), based on the participant's diary and scored from zero (no blood) to three (blood only passed);
Endoscopy Subscore (ESS), based on colonoscopy or sigmoidoscopy and scored from zero (normal or inactive disease) to three (severe disease, spontaneous bleeding, ulceration);
Physician's Global Assessment (PGA) subscore, based on the physician's overall assessment, and scored from zero (normal) to three (severe disease).
The total Mayo score ranges from 0 to 12 points, with higher scores representing more severe disease."|Week 52|Full analysis set. Non-responder imputation (NRI) was used, where all missing remission values and values after the start of rescue treatment were considered as non-remission.||percentage of participants|||Number
788873|NCT00853099|Primary|Percentage of Participants With Clinical Remission at 8 Weeks|"Clinical remission was defined as a Mayo score ≤ 2 with no individual subscore > 1. The Mayo score is a composite score of ulcerative colitis disease activity calculated as the sum of four subscores:
Stool Frequency Subscore (SFS), based on the participant's diary and scored from zero (normal number of stools) to three (5 or more stools than normal);
Rectal Bleeding Subscore (RBS), based on the participant's diary and scored from zero (no blood) to three (blood only passed);
Endoscopy Subscore (ESS), based on colonoscopy or sigmoidoscopy and scored from zero (normal or inactive disease) to three (severe disease, spontaneous bleeding, ulceration);
Physician's Global Assessment (PGA) subscore, based on the physician's overall assessment, and scored from zero (normal) to three (severe disease).
The total Mayo score ranges from 0 to 12 points, with higher scores representing more severe disease."|Week 8|The full analysis set includes all patients who received at least 1 dose of study drug any time during the first 52 weeks and with at least 1 efficacy measurement after the first dose of study medication. Non-responder imputation (NRI) was used, where all missing values and values after the start of rescue treatment were considered non-remission.||percentage of participants|||Number
788874|NCT00853151|Secondary|Change From Baseline in Homeostatic Model Assessment (HOMA) at 3-Week and 6-Month Endpoints|Values from repeated measures include fixed categorical effects of treatment, baseline therapy strata, visit, treatment-by-visit, continuous fixed covariate of baseline HOMA derived beta-cell function (HOMA-B). HOMA=index of function of cells that make insulin. Indices derived from fasting glucose and insulin concentrations. HOMA is measurement reflecting fasting plasma glucose and insulin. Has no defined minimum/maximum value. HOMA-B values generated from table reflecting values derived from Oxford HOMA2 model calculator. Change from baseline=absolute change from baseline (endpoint-baseline).|Baseline (Week -1), 3 weeks, 6 months|Intent-to-treat: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline HOMA value.||units on a scale||Standard Error|Least Squares Mean
788875|NCT00853151|Secondary|Change From Baseline in Fasting Insulin at 4-Week and 6-Month Endpoints|Values obtained from repeated measures analysis, which included the fixed categorical effects of treatment, baseline therapy strata (metformin versus diet and exercise [D&E]), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariate of baseline Fasting Insulin. Fasting insulin is the Mixed-Meal Tolerance Test (MMTT) insulin assessment at timepoint 0, where available, otherwise it is the assessment taken from the fasting laboratory measurements obtained during the clinic visit. Change from baseline means the absolute change from baseline (endpoint-baseline).|Baseline (Week -1), 4 weeks, 6 months|Intent-to-treat: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline fasting insulin value.||microinternational units/milliliter||Standard Error|Least Squares Mean
788876|NCT00853151|Secondary|Number of Participants With Adjudicated and Confirmed Deaths and Non-Fatal Cardiovascular (CV) Events at Any Timepoint|The protocol specified that deaths and nonfatal cardiovascular (CV) adverse events (AEs) be adjudicated by independent physician(s) with cardiology or neurology experience. The CV AEs to be adjudicated were protocol-defined as myocardial infarction (MI), hospitalization for unstable angina or for heart failure, coronary interventions (coronary artery bypass graft or percutaneous coronary intervention [PCI]) and cerebrovascular events including cerebrovascular accident (stroke) and transient ischemic attack (TIA). 3 CV events were adjudicated by an external independent adjudication committee.|Baseline (Week -1) through 6 months|All participants who received at least 1 dose of TT223 or its placebo.||participants|||Number
788877|NCT00853151|Secondary|Number of Participants With Hypoglycemia|The number of participants for whom low blood glucose was reported. Hypoglycemia ≥1 events including: severe hypoglycemia(glucose <50mg/dL, unable to treat self or recover after treatment); documented symptomatic (glucose ≤70mg/dL, adrenergic or neuroglycopenic symptoms); asymptomatic (glucose ≤70mg/dL no symptoms); probable symptomatic (glucose missing, adrenergic or neuroglycopenic symptoms); relative (glucose >70mg/dL, adrenergic or neuroglycopenic symptoms), nocturnal (glucose ≤70mg/dL, adrenergic or neuroglycopenic symptoms between bedtime/waking).|Baseline (Week -1) through 6 months|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.||participants|||Number
788878|NCT00853151|Secondary|Percentage of Participants With Hypoglycemia|Calculation of frequency of low glucose for time period. Hypoglycemia≥1 events: severe<50mg/dL, unable to treat self/recover after treatment; documented symptomatic≤70mg/dL, adrenergic/neuroglycopenic symptoms; asymptomatic≤70mg/dL no symptoms; probable symptomatic glucose missing, adrenergic/neuroglycopenic symptoms; relative>70mg/dL, adrenergic/neuroglycopenic symptoms, nocturnal≤70mg/dL, adrenergic/neuroglycopenic symptoms between bedtime/waking. Because number participants who experienced hypoglycemia was low for every arm (1-3/arm) did not model percentage participants with hypoglycemia.|Baseline (Week -1) through 6 months|Because the number of hypoglycemia events were too low to model the percentage of hypoglycemia, zero participants were analyzed.||percentage of participants|||Number
788879|NCT00853151|Secondary|Percentage of Participants With 2-Fold Elevation of Lipase and/or Amylase at Any Timepoint|Values obtained from repeated measures analysis, which included the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the continuous, fixed covariate of baseline amylase.|Baseline (Week -1) through 6 months|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.||percentage of participants|||Number
788880|NCT00853151|Secondary|Change From Baseline in Amylase at 6-Month Endpoint|Change from baseline means the absolute change from baseline (endpoint-baseline).|Baseline (Week -1), 6 months|Intent-to-treat (ITT): All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline amylase value.||units/liter (U/L)||Standard Error|Least Squares Mean
788881|NCT00853151|Secondary|Change From Baseline in Lipase at Week 0, Week 4, and 6-Month Endpoints|Values obtained from repeated measures analysis, which included the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the continuous, fixed covariate of baseline serum lipase. Change from baseline means the absolute change from baseline (endpoint-baseline).|Baseline (Week -1), Week 0, 4 weeks, 6 months|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.||units per liter (U/L)||Standard Error|Least Squares Mean
788882|NCT00853151|Secondary|Change From Baseline in 7-Point Profile, Self-Monitored Blood Glucose (SMBG) at 4-Week and 6-Month Endpoints|7-point average=average of mean value of all time points for visit (premorning meal, 2-hours postmorning meal, premidday meal, 2-hours postmidday meal, preevening meal, 2-hours postevening meal, bedtime). Values represent mean of values collected same time on 3 separate days within week prior to visit. Values from repeated measures included fixed categorical effects: treatment, baseline therapy strata, visit, treatment-by-visit, continuous fixed covariate baseline <7-point average glucose value or time point presented. Change from baseline=absolute change from baseline (endpoint-baseline).|Baseline (Week -1), 4 weeks, 6 months|Intent-to-treat (ITT): All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value for the variable being analyzed.||milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
788883|NCT00853151|Secondary|7-point Profile, Self-Monitored Blood Glucose (SMBG) Values|The 7-point average is the average of the mean value of all time points for the visit. Time points included pre-morning meal, 2 hours after morning meal, pre-midday meal, 2 hours after midday meal, pre-evening meal, 2 hours after evening meal, and bedtime.|Baseline (Week -1), 4 weeks, 6 months|Each visit includes participants who received at least 1 dose of TT223 or its placebo who had both a baseline value and a value at that visit.||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
788884|NCT00853151|Secondary|Change From Baseline in Waist Circumference at 6-Month Endpoint|Change from baseline means the absolute change from baseline (endpoint-baseline).|Baseline (Week -1), 6 months|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.||centimeters (cm)||Standard Deviation|Mean
788885|NCT00853151|Secondary|Visual Analog Scale (VAS) for Nausea|The Visual Analog Scale (VAS) is a continuous measure for degree of nausea and/or gastrointestinal discomfort. Each of these scales is 100 millimeters (mm) in length with 0 meaning no nausea at all and 100 meaning extreme nausea. Participants record self-assessment of how much nausea they have had, from 0 to 100, during the time interval indicated.|4 weeks, 6 months|Each visit includes participants who received at least 1 dose of TT223 or its placebo who had both a baseline value and a value at that visit.||units on a scale||Standard Deviation|Mean
788886|NCT00853151|Secondary|Pharmacokinetics (PKs) of LY2428757, 3-Week Time Point - Maximum Observed Drug Concentration (Cmax)|Maximum observed drug concentration (Cmax) is the maximum observed concentration of drug. LY2428757 concentrations were collected at only a single timepoint; therefore, pharmacokinetic (PK) parameters could not be modeled from the data. Analysis was not done due to insufficient time points being collected.|0 (pre-dose)|Analyses were not conducted due to insufficient time points being collected; zero participants were analyzed.||nanograms per milliliter (ng/ml)||Geometric Coefficient of Variation|Geometric Mean
788887|NCT00853151|Secondary|Pharmacokinetics (PKs) of TT223, 3-Week Time Point - Apparent Volume of Distribution During the Terminal Phase After Extra-Vascular Administration (Vz/F), Apparent Volume of Distribution at Steady-State After Extra-Vascular Administration (Vss/F)|Apparent volume of distribution during the terminal phase after extra-vascular administration (Vz/F) is the apparent volume that contains drug after absorption is complete and drug is no longer being given. Apparent volume of distribution at steady-state after extra-vascular administration (Vss/F) is the apparent volume that contains drug when drug is being given continuously.|0 (pre-dose), 0.33, 0.5, 1, 2, 3, 4, 6 hours|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.||liters (L)||Geometric Coefficient of Variation|Geometric Mean
788888|NCT00853151|Secondary|Pharmacokinetics (PKs) of TT223, 3-Week Time Point - Apparent Total Body Clearance of Drug Calculated After Extra-Vascular Administration (CL/F)|Apparent total body clearance of drug calculated after extra-vascular administration (CL/F) is the apparent volume of the body fluid cleared of the drug per unit of time, adjusted for how much drug goes into the body fluid.|0 (pre-dose), 0.33, 0.5, 1, 2, 3, 4, 6 hours|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.||liters per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
788889|NCT00853151|Secondary|Pharmacokinetics (PKs) of TT223, 3-Week Time Point - Area Under Concentration Versus Time From Zero to Infinity (AUC[0-infinity])|Area under concentration versus time curve from zero to infinity (AUC[0-infinity]). Area under the curve (AUC) is a measure of the total exposure to a drug.|0 (pre-dose), 0.33, 0.5, 1, 2, 3, 4, 6 hours|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.||nanograms*hour/milliliter (ng*hr/ml)||Geometric Coefficient of Variation|Geometric Mean
788890|NCT00853151|Secondary|Pharmacokinetics (PKs) of TT223, 3-Week Time Point - Half Life (t1/2)|Half-life (t1/2) is the time it takes for the concentration of drug in plasma to decline by 50%.|0 (pre-dose), 0.33, 0.5, 1, 2, 3, 4, 6 hours|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.||hours||Geometric Coefficient of Variation|Geometric Mean
788891|NCT00853151|Secondary|Pharmacokinetics (PKs) of TT223, 3-Week Time Point - Time of Maximum Observed Drug Concentration (Tmax)|Time of maximum observed drug concentration (Tmax) is the time at which the maximum observed concentration (Cmax) occurs.|0 (pre-dose), 0.33, 0.5, 1, 2, 3, 4, 6 hours|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.||hours||Full Range|Geometric Mean
788892|NCT00853151|Secondary|Pharmacokinetics (PKs) of TT223, 3-Week Time Point - Maximum Observed Drug Concentration (Cmax)|Maximum observed drug concentration (Cmax) is the maximum observed concentration of drug.|0 (pre-dose), 0.33, 0.5, 1, 2, 3, 4, 6 hours|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.||nanograms per milliliter (ng/ml)||Geometric Coefficient of Variation|Geometric Mean
788893|NCT00853151|Secondary|Pharmacokinetics (PKs) of TT223, First Dose - Apparent Volume of Distribution During the Terminal Phase After Extra-Vascular Administration (Vz/F), Apparent Volume of Distribution at Steady-State After Extra-Vascular Administration (Vss/F)|volume of distribution during the terminal phase after extra-vascular administration (Vz/F): Apparent volume that contains drug after absorption is complete and drug is no longer being given. Apparent volume of distribution at steady-State after extra-vascular administration (Vss/F): Apparent volume that contains drug when drug is being given continuously.|0 (pre-dose), 0.33, 0.5, 1, 2, 3, 4, 6 hours|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.||liters (L)||Geometric Coefficient of Variation|Geometric Mean
788894|NCT00853151|Secondary|Pharmacokinetics (PKs) of TT223, First Dose - Apparent Total Body Clearance of Drug Calculated After Extra-Vascular Administration (CL/F)|Apparent total body clearance of drug calculated after extra-Vascular administration (CL/F) is the apparent volume of the body fluid cleared of the drug per unit of time, adjusted for how much drug goes into the body fluid.|0 (pre-dose), 0.33, 0.5, 1, 2, 3, 4, 6 hours|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.||liters/hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
788895|NCT00853151|Secondary|Pharmacokinetics (PKs) of TT223, First Dose - Area Under the Curve (AUC)(0-infinity)|Area under the curve (AUC)(0-infinity) = area under concentration versus time from zero to infinity. Area under the curve (AUC) is a measure of the total exposure to a drug.|0 (pre-dose), 0.33, 0.5, 1, 2, 3, 4, 6 hours|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.||nanograms*hour/milliliter (ng*hr/ml)||Geometric Coefficient of Variation|Geometric Mean
788896|NCT00853151|Secondary|Pharmacokinetics (PKs) of TT223, First Dose - Half-Life (t1/2) Associated With the Terminal Rate Constant (λz) in Non-Compartmental Analysis|Half-life is the time it takes for the concentration of drug in plasma to decline by 50%.|0 (pre-dose), 0.33, 0.5, 1, 2, 3, 4, 6 hours|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.||hours||Geometric Coefficient of Variation|Geometric Mean
788897|NCT00853151|Secondary|Pharmacokinetics (PKs) of TT223, First Dose - Maximum Observed Drug Concentration (Cmax)|Maximum observed drug concentration (Cmax) is the maximum observed concentration of drug.|0 (pre-dose), 0.33, 0.5, 1, 2, 3, 4, 6 hours|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.||nanograms per milliliter (ng/ml)||Geometric Coefficient of Variation|Geometric Mean
788898|NCT00853151|Secondary|Pharmacokinetics (PKs) of TT223, First Dose - Time of Maximum Observed Drug Concentration (Tmax)|Time of maximum observed drug concentration (Tmax) is the time at which the maximum observed concentration (Cmax) occurs.|0 (pre-dose), 0.33, 0.5, 1, 2, 3, 4, 6 hours|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.||hours||Full Range|Geometric Mean
788899|NCT00853151|Secondary|Number of Participants With Antibodies to TT223|Participants who were positive for antibodies for TT223.|Baseline (Week -1) through 6 months|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.||participants|||Number
788900|NCT00853151|Secondary|Number of Participants With Antibodies to LY2428757|Participants who were positive for antibodies to LY2428757.|Baseline (Week -1) through 6 months|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.||participants|||Number
788921|NCT00853333|Primary|Pain Rating Change|"Mechanical Slide Algometer (www.decisionaidsonline.com), Range: No Pain Sensation (1) to  Most Intense Sensation Imaginable (10) 10 point scale.
Change Time Points: Baseline (no sedation), Sedation. Same Day Intervention."|Sedation|||units on a scale||Standard Error|Least Squares Mean
788901|NCT00853151|Secondary|Mean Change From Baseline in Weight at Week 0, Week 4, and 6-Month Endpoints|Values obtained from repeated measures analysis, which included the fixed categorical effects of treatment, baseline therapy strata (metformin versus diet and exercise [D&E]), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariate of baseline weight. Change from baseline means the absolute change from baseline (endpoint-baseline).|Baseline (Week -1), Week 0, 4 weeks, 6 months|Intent-to-treat (ITT): All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline weight value.||kilograms (kg)||Standard Error|Least Squares Mean
788902|NCT00853151|Secondary|Change From Baseline in Fasting Blood Glucose (FBG) Adjusted for Baseline HbA1c, C-Peptide Level, Homeostasis Model Assessment of Insulin Resistance, Duration of Diabetes, and Weight at 3-Week, 4-Week, 2-Month, 3.5-Month, 5-Month, and 6-Month Endpoints|The subgroup analyses for fasting blood glucose (FBG) (adjusted for baseline glycosylated hemoglobin [HbA1c]), C-peptide level, homeostasis model assessment of insulin resistance (HOMA), duration of diabetes, and weight) were not performed due to the lack of statistically significant findings in the subgroup analysis for the glycosylated hemoglobin (HbA1c) analyses. Change from baseline means the absolute change from baseline (endpoint-baseline).|Baseline (Week -1), 3 weeks, 4 weeks, 2 months, 3.5 months, 5 months, 6 months|||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
788903|NCT00853151|Secondary|Change From Baseline in MMTT Response (Postprandial Glucose, Glucose AUC, Insulin/c-Peptide Secretory Response, HOMA, GLP-1, Glucagon) Adjusted for Baseline HbA1c, C-Peptide Level, HOMA, Duration of Diabetes, Weight at Week 0, 3, Month 3.5, 6 Endpoints|Subgroup analyses for mixed meal tolerance test (MMTT) response (adjusted for baseline glycosylated hemoglobin (HbA1c), C-peptide level, Homeostasis Model Assessment of Insulin Resistance (HOMA), duration of diabetes, weight) not performed due to lack of statistically significant findings in subgroup analysis for HbA1c analyses. HOMA was not done for mixed meal tolerance test (MMTT) because it is not calculated from the mixed meal tolerance test (MMTT). It is reported separately as a secondary outcome measure. Change from baseline=absolute change from baseline (endpoint-baseline).|Baseline (Week -1), Week 0, 3 weeks, 3.5 months, 6 months|Because the subgroup analyses for MMTT response were not conducted due to the lack of statistically significant findings in the subgroup analysis for the HbA1c analyses, zero participants were analyzed.||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
788904|NCT00853151|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1C) Adjusted for Baseline Glycosylated Hemoglobin (HbA1c), C-Peptide Level, Homeostasis Model Assessment of Insulin Resistance (HOMA), Duration of Diabetes, and Body Mass Index (BMI) at 6-Month Endpoint|HbA1c adjusted: baseline HbA1c (<8%,≥8%); C-peptide level (normal, elevated); HOMA (<baseline median,≥baseline median); duration diabetes (<3,3-10,>10 years); BMI (<30,≥30). BMI estimates body fat based on weight/height squared. HOMA: index of function of cells that make insulin/insulin resistance. Indices derived from fasting glucose and insulin concentrations. LS means adjusted for treatment, baseline therapy, visit, treatment-by-visit, subgroup, subgroup-by-treatment, subgroup-by-visit, subgroup-by-treatment-by-visit. Change from baseline=absolute change from baseline (endpoint-baseline).|Baseline (Week -1), 6 months|Intent-to-treat (ITT): All participants who received at least 1 dose of TT223 or its placebo with a baseline and at least 1 post-baseline value.||percent glucosylated hemoglobin (HbA1c)||Standard Error|Least Squares Mean
788905|NCT00853151|Secondary|Change From Baseline in Fasting Blood Glucose (FBG) at 4-Week and 6-Month Endpoints|Values obtained from repeated measures analysis, which included the fixed categorical effects of treatment, baseline therapy strata (metformin versus diet and exercise [D&E]), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariate of baseline fasting blood glucose (FBG). Fasting blood glucose (FBG) is the mixed meal tolerance test (MMTT) glucose assessment at time point 0, where available, otherwise it is the assessment taken from the chemistry panel. Change from baseline means the absolute change from baseline (endpoint-baseline).|Baseline (Week -1), 4 weeks, 6 months|Intent-to-treat (ITT): All participants who received at least 1 dose of TT223 or its placebo with a baseline and at least 1 post-baseline fasting blood glucose (FBG) value.||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
788906|NCT00853151|Secondary|Change From Baseline in Mixed-Meal Tolerance Test (MMTT) Response - Post-Prandial Glucose at 3-Week and 6-Month Endpoints|Standardized MMTT to assess changes in function of cells that make insulin (pancreatic beta cells). Glucose measured at 2-hour timepoint during MMTT reflects glucose values in response to meal. Change in postprandial glucose calculated based on difference of 2-hour postprandial glucose at endpoint compared to baseline. Larger changes from baseline represent a greater postprandial glucose compared to 2-hour timepoint prior to treatment. Least squares (LS) means adjusted for baseline, treatment, visit, treatment-by-visit. Change from baseline=absolute change from baseline (endpoint-baseline).|Baseline (Week -1), 3 weeks, 6 months|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a value at Week -1 and a value at that visit and time point being assessed.||millimoles/liter (mmol/L)||Standard Error|Least Squares Mean
788907|NCT00853151|Secondary|Change From Baseline in Mixed-Meal Tolerance Test (MMTT) Response - Glucagon-like Peptide-1 (GLP-1) Area Under the Cure (AUC) at 3-Week and 6-Month Endpoints|Standardized mixed meal tolerance test (MMTT) to assess changes in hormones in response to meal. Area under plasma glucagon-like peptide-1 (GLP-1) concentration versus time curve calculated using linear-trapezoidal method. Area under the curve (AUC) for glucagon-like peptide-1 (GLP-1) represents the AUC of GLP-1 values when plotted over time. Larger AUC values represent a greater average GLP-1 value over time in response to meal. Least squares (LS) means adjusted for baseline, treatment, visit, treatment-by-visit. Change from baseline=absolute change from baseline (endpoint-baseline).|Baseline (Week -1), 3 weeks, 6 months|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a value at Week -1 and a value at that visit.||picomoles/liter (pmmol/L)||Standard Error|Least Squares Mean
788922|NCT00853385|Secondary|Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 12|Work performance of participants on number of days bothered was based on 10-point scale, where higher score indicated lower work performance.|Month 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
788908|NCT00853151|Secondary|Change From Baseline in Mixed-Meal Tolerance Test (MMTT) Response - Glucagon Area Under the Curve (AUC) at 3-Week and 6-Month Endpoints|Standardized mixed meal tolerance test (MMTT) to assess changes in hormones in response to meal. Area under the plasma glucagon concentration versus time curve was calculated using the linear-trapezoidal method. Area under the curve (AUC) for glucagon represents the AUC of glucagon values when are plotted over time. Larger area under the curve (AUC) values represent a greater average glucagon value over time in response to a meal. Least squares (LS) means adjusted for baseline, treatment, visit, treatment-by-visit. Change from baseline=absolute change from baseline (endpoint-baseline).|Baseline (Week -1), 3 weeks, 6 months|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a value at Week -1 and a value at that visit.||picomoles/liter (pmmol/L)||Standard Error|Least Squares Mean
788909|NCT00853151|Secondary|Change From Baseline in Mixed Meal Tolerance Test (MMTT) Response - Ratio of Insulin Area Under the Curve (AUC)/Glucose Area Under the Curve (AUC) at 3-Week and 6-Month Endpoints|Mixed meal tolerance test (MMTT) to assess changes in function of cells making insulin. AUCinsulin/AUCglucose ratio: index of insulin secretion. Larger values reflect greater secretion adjusted for glucose in response to meal. Area under insulin concentration versus time curve and area under plasma glucose concentration versus time curve calculated using linear-trapezoidal method. AUC for insulin and glucose represents AUC of values plotted over time. LS means adjusted for baseline, treatment, visit, treatment-by-visit. Change from baseline=absolute change from baseline (endpoint-baseline).|Baseline (Week -1), 3 weeks, 6 months|Intent-to-treat population (ITT): All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline AUC insulin/AUC glucose value. Reporting is on the 131 participants who received either TT223 or its placebo and reflects data only from the treatment and follow-up phases of the study.||millimoles/liter*hour (mmol/L*hr)||Standard Error|Least Squares Mean
788910|NCT00853151|Secondary|Change From Baseline in Mixed-Meal Tolerance Test (MMTT) Response - C-Peptide Area Under the Curve (AUC) at 3-Week and 6-Month Endpoints|The area under the C-peptide concentration versus time curve was calculated using the linear-trapezoidal method. Area under the curve (AUC) for C-peptide represents area under the curve (AUC) of C-peptide values when plotted over time. Larger area under the curve (AUC) values represent a greater average C-peptide value over time in response to a meal. Least squares (LS) means adjusted for baseline, treatment, visit, treatment-by-visit interaction. Change from baseline means the absolute change from baseline (endpoint-baseline).|Baseline (Week -1), 3 weeks, 6 months|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline C-peptide area under the curve (AUC) value.||millimoles/liter*hour (mmol/L*hr)||Standard Error|Least Squares Mean
788911|NCT00853151|Secondary|Change From Baseline in Mixed-Meal Tolerance Test (MMTT) Response - Glucose Area Under the Curve (AUC) at 3-Week and 6-Month Endpoints|Standardized mixed-meal tolerance test (MMTT) used to assess changes in function of cells that make insulin (pancreatic beta cell function). Area under the plasma glucose concentration versus time curve calculated using linear-trapezoidal method. AUC for glucose represents area under curve of values when plotted over time. Larger area under the curve values represent greater average glucose value over time in response to meal. Least squares (LS) means adjusted for baseline, treatment, visit, treatment-by-visit. Change from baseline=absolute change from baseline (endpoint-baseline).|Baseline (Week -1), 3 weeks, 6 months|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline value and at least 1 post-baseline glucose area under the curve (AUC) value.||millimoles/liter*hour (mmol/L*hr)||Standard Error|Least Squares Mean
788912|NCT00853151|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 4-Week Endpoint|Values obtained from repeated measures analysis, which included the fixed categorical effects of treatment, baseline therapy strata (metformin versus diet and exercise [D&E]), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariate of baseline glycosylated hemoglobin (HbA1c). Change from baseline means the absolute change from baseline (endpoint-baseline).|Baseline (Week -1), 4 weeks|Intent-to-treat (ITT): All participants who received at least 1 dose of TT223 or its placebo with a baseline and at least 1 post-baseline glycosylated hemoglobin (HbA1c) value.||percent glycosylated hemoglobin (HbA1c)||Standard Error|Least Squares Mean
788913|NCT00853151|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 6-Month Endpoint|Values obtained from repeated measures analysis, which included the fixed categorical effects of treatment, baseline therapy strata (metformin versus diet and exercise [D&E]), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariate of baseline glycosylated hemoglobin (HbA1c). Change from baseline means the absolute change from baseline (endpoint-baseline).|Baseline (Week -1), 6 months|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline glycosylated hemoglobin (HbA1c) value.||percent glycosylated hemoglobin (HbA1c)||Standard Error|Least Squares Mean
788914|NCT00853229|Secondary|Effect on Anxiety and Depression in Women With Vulvodynia Based on the Kessler Psychological Distress Scale (K10)|Data not measured due to early discontinuation of the study prior to the designated follow up time frame.|4 weeks||||||
788915|NCT00853229|Primary|Reduction in Average Pain Over the Last 7 Days of Each Arm Using an 11-point Scale (0-10)|Outcomes measure not assessed due to early discontinuation because of poor recruitment. As such, the study was terminated prior to the designated follow up interval. Therefore, no outcomes data was collected.|4 weeks||||||
788916|NCT00853242|Secondary|Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol at Day 22||Baseline, Day 22|Full Analysis Set.||mg/dL||Standard Deviation|Mean
788917|NCT00853242|Secondary|Change From Baseline in Total Cholesterol at Day 22||Baseline, Day 22|Full Analysis Set.||mg/dL||Standard Deviation|Mean
788918|NCT00853242|Secondary|Change From Baseline in Serum Calcium (Albumin-adjusted)-Phosphorus Product at Week 22||Baseline, Day 22|Full Analysis Set.||mg^2/dL^2||Standard Deviation|Mean
788919|NCT00853242|Secondary|Change From Baseline in Serum Phosphorus at Day 22 (Genz-644470 vs Sevelamer Carbonate)||Baseline, Day 22|FAS included all participants who received at least one dose of study drug and had baseline and at least one post-baseline phosphorus measure <= 3 days after date of last study drug.||mg/dL||Standard Deviation|Mean
789148|NCT00861471|Secondary|Median Overall Survival Time|Overall survival time is the time from the start of therapy till death. Median overall survival reported here is the time when 50% of the participants are alive.|up to 4 years|Based on intent-to-treat population||months||95% Confidence Interval|Median
788923|NCT00853385|Secondary|Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 6|Work performance of participants on number of days bothered was based on 10-point scale, where higher score indicated lower work performance.|Baseline, Month 3, 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
788924|NCT00853385|Secondary|Number of Hours Per Day as Assessed RA-HCRU at Month 12|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, hours affected per day and average number of hours missed work per day were reported.|Month 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||hours per day||Standard Deviation|Mean
788925|NCT00853385|Secondary|Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, hours affected per day and average number of hours missed work per day were reported.|Baseline, Month 3, 6|FAS: all randomized participants who received at least 1 dose of study drug, had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||hours per day||Standard Deviation|Mean
788926|NCT00853385|Secondary|Number of Days as Assessed Using RA-HCRU at Month 12|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.|Month 12|FAS: all randomized participants who received at least 1 dose of study drug, had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||days||Standard Deviation|Mean
788927|NCT00853385|Secondary|Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.|Baseline, Month 3, 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||days||Standard Deviation|Mean
788928|NCT00853385|Secondary|Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.|Month 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||events||Standard Deviation|Mean
788929|NCT00853385|Secondary|Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.|Baseline, Month 3, 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||events||Standard Deviation|Mean
788930|NCT00853385|Secondary|Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12|RA-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, NM practitioner, nursing home, hospital, surgery, ER treatment, diagnostic tests, over-night stay, home HC services, and aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score indicated higher medical cost.|Month 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
788931|NCT00853385|Secondary|Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6|Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost: any RA/non-RA related medical/non-medical (NM) practitioner visit, nursing home, hospital, surgery, emergency room (ER) treatment, diagnostic tests, over-night stay, home healthcare (HC) services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score indicated higher medical cost.|Baseline, Month 3, 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
788932|NCT00853385|Secondary|Work Limitations Questionnaire (WLQ) Score at Baseline and Month 12|WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: 5-items Time Management scale (TMS); 6-items Physical Demands scale (PDS); 9-items Mental-Interpersonal Demands Scale (MIDS); 5-items Output Demands scale (ODS). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index (WLI), which represented percentage of lost work over time period relative to a normative population, was derived (total score: 0 [no loss] to 100 [complete loss of work]).|Baseline, Month 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
788933|NCT00853385|Secondary|Work Limitations Questionnaire (WLQ) Score at Month 3 and 6|WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: 5-items Time Management scale (TMS); 6-items Physical Demands scale (PDS); 9-items Mental-Interpersonal Demands Scale (MIDS); 5-items Output Demands scale (ODS). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index (WLI), which represented percentage of lost work over time period relative to a normative population, was derived (total score: 0 [no loss] to 100 [complete loss of work]).|Month 3, 6|FAS: all randomized participants who received at least 1 dose of study drug, had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
788934|NCT00853385|Secondary|Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Month 12|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Month 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure.||units on a scale||Standard Deviation|Mean
788935|NCT00853385|Secondary|Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Baseline, Month 1, 3 and 6|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Baseline, Month 1, 3, 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
788936|NCT00853385|Secondary|Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12|MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported.|Month 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure.||participants|||Number
788937|NCT00853385|Secondary|Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6|MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported.|Baseline, Month 1, 3, 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). n=number of participants evaluable at specific time points for each arm group, respectively.||participants|||Number
788938|NCT00853385|Secondary|Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12|Participant-rated questionnaire to assess key constructs of sleep over the past week. Consists of a 12-item based on 7 sub scales: sleep disturbance (SD), snoring (Sno), awakened short of breath (ASOB) or with headache, sleep adequacy (Ade), and somnolence (Som) (range:0-100); sleep quantity (Qua)(range:0-24), and optimal (Opt) sleep (yes: 1, no: 0) and nine item index measures of sleep disturbance were constructed to provide composite scores: sleep problem summary (SPS) and overall sleep problems (OSP). Except sleep adequacy, optimal sleep and quantity, higher scores=greater impairment. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute.|Month 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
788948|NCT00853385|Secondary|Patient Assessment of Arthritis Pain at Month 9 and 12|Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.|Month 9, 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||mm||Standard Deviation|Mean
788939|NCT00853385|Secondary|Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6|Participant-rated questionnaire to assess key constructs of sleep over the past week. Consists of a 12-item based on 7 sub scales: sleep disturbance (SD), snoring (Sno), awakened short of breath (ASOB) or with headache, sleep adequacy (Ade), and somnolence (Som) (range:0-100); sleep quantity (Qua)(range:0-24), and optimal (Opt) sleep (yes: 1, no: 0) and nine item index measures of sleep disturbance were constructed to provide composite scores: sleep problem summary (SPS) and overall sleep problems (OSP). Except sleep adequacy, optimal sleep and quantity, higher scores=greater impairment. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute.|Baseline, Month 1, 3, 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
788940|NCT00853385|Secondary|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Month 12|FACIT-Fatigue scale is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.|Month 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure.||units on a scale||Standard Deviation|Mean
788941|NCT00853385|Secondary|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Baseline, Month 1, 3 and 6|FACIT-Fatigue scale is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.|Baseline, Month 1, 3, 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
788942|NCT00853385|Secondary|36-Item Short-Form Health Survey (SF-36) at Month 9 and 12|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and was reported as 2 summary scores; Physical Component Score and Mental Component Score. Total score range for the summary scores = 0-100 where higher scores represented higher level of functioning.|Month 9, 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
788943|NCT00853385|Secondary|36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and was reported as 2 summary scores; Physical Component Score and Mental Component Score. Total score range for the summary scores = 0-100 where higher scores represented higher level of functioning.|Baseline, Month 1, 3, 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
788944|NCT00853385|Secondary|Physician Global Assessment (PGA) of Arthritis Pain at Month 9 and 12|Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.|Month 9, 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||mm||Standard Deviation|Mean
788945|NCT00853385|Secondary|Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Month 1, 3 and 6|Physician global assessment of arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.|Baseline, Month 1, 3, 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||mm||Standard Deviation|Mean
788946|NCT00853385|Secondary|Patient Global Assessment (PtGA) of Arthritis Pain at Month 9 and 12|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly."|Month 9, 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||mm||Standard Deviation|Mean
788947|NCT00853385|Secondary|Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Month 1, 3 and 6|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly."|Baseline, Month 1, 3, 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). n=number of participants evaluable at specific time points for each arm group, respectively.||mm||Standard Deviation|Mean
788949|NCT00853385|Secondary|Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 and 6|Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) visual analogue scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.|Baseline, Month 1, 3, 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). n=number of participants evaluable at specific time points for each arm group, respectively.||mm||Standard Deviation|Mean
788950|NCT00853385|Secondary|Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 9 and 12|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3:0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.|Month 9, 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
788951|NCT00853385|Secondary|Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 1, 3 and 6|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3:0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.|Month 1, 3, 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
788952|NCT00853385|Secondary|Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR])|DAS28-3 (ESR) was calculated from SJC and TJC using 28 joint count and ESR (mm/hour). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Baseline, Month 1, 3, 6, 9, 12|Data was not analyzed for DAS28-3 (ESR) due to change in planned analyses.|||||
788953|NCT00853385|Secondary|Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])|DAS28-4 [CRP] calculated from SJC and TJC using 28 joint count, CRP (mg/L) and PGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Baseline, Month 1, 3, 6, 9, 12|Data was not analyzed for DAS28-4 (CRP) due to change in planned analyses.|||||
788954|NCT00853385|Secondary|Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 9 and 12|DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Month 9, 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
788955|NCT00853385|Secondary|Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 1, 3 and 6|DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Baseline, Month 1, 3, 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
788956|NCT00853385|Secondary|Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9 and 12|DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Month 9, 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
788957|NCT00853385|Secondary|Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Month 1, 3 and 6|DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (milligram per liter [mg/L]). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Baseline, Month 1, 3, 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
788982|NCT00853593|Secondary|Cannulation Time|Cannulation time was defined as the time from insertion of the first coronary sinus (CS) cannulation catheter to the first successful CS cannulation.|During implant procedure.|Subjects successfully implanted with a Model 4396 lead.||minutes||Standard Deviation|Mean
788958|NCT00853385|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 9 and 12|ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Month 9, 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed using NRI.||percentage of participants|||Number
788959|NCT00853385|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 1, 3 and 6|ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Month 1, 3, 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed using NRI.||percentage of participants|||Number
788960|NCT00853385|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 9 and 12|ACR50 response: >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Month 9, 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed using NRI.||percentage of participants|||Number
788961|NCT00853385|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 1, 3 and 6|ACR50 response: >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Month 1, 3, 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed using NRI.||percentage of participants|||Number
788962|NCT00853385|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 9 and 12|ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Month 9, 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed using NRI.||percentage of participants|||Number
788963|NCT00853385|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 1 and 3|ACR20 response: >=20% improvement in TJC; >= 20% improvement in SJC; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Month 1, 3|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed using NRI.||percentage of participants|||Number
788964|NCT00853385|Primary|Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 6|DAS28-4 (ESR) calculated from SJC and TJC using 28-joint count, erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) less than or equal to (<=) 3.2 implied low disease activity and > 3.2 to 5.1 implied moderate to high disease activity, and < 2.6 = remission. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.|Month 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed using non-responder imputation (NRI).||percentage of participants|||Number
788965|NCT00853385|Primary|Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 3|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis.|Baseline, Month 3|Full analysis set (FAS): all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
790384|NCT00867451|Primary|Sleep Duration|Data was gathered via actigraphy. Data was gathered on a nightly basis for one week at baseline and at week five. Data presented is the mean nightly value (in minutes) for that week.|Baseline; Week 5|||minutes||Standard Deviation|Mean
788966|NCT00853385|Primary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6|ACR20 response: greater than or equal to (>=) 20% improvement in tender joint count (TJC); >= 20% improvement in swollen joint count (SJC); and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP). For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.|Month 6|Full analysis set: all randomized participants who received >=1 dose and had >=1 post-baseline and baseline measurement (change from baseline endpoint). N(number of participants analyzed)=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed by non-responder imputation.||percentage of participants|||Number
788967|NCT00853567|Primary|To Determine the Efficacy of 50 mg Proellex® Versus Placebo in the Treatment of Subjects With Symptomatic Uterine Fibroids From Baseline to Month 4 as Determined by Scoring Changes in the Pictorial Blood Loss Assessment Chart (PBAC)||4 months|Study prematurely terminated|||||
788968|NCT00853593|Secondary|Characterize Model 4396 Electrical Performance- Bipolar Configuration: Sensing|Bipolar sensing, measured by R-wave amplitude, for the Model 4396 was collected at implant, pre-hospital discharge and all scheduled follow-up visits. Measurements at the 6 month visit are presented here.|6 month|Subjects with bipolar configuration electrode R-wave amplitude at 6 month.||mV||Standard Deviation|Mean
788969|NCT00853593|Secondary|Characterize Model 4396 Electrical Performance- Bipolar Configuration: Pacing Impedance|Subjects' bipolar pacing impedance was measured at implant, pre-hospital discharge and all scheduled follow-up visits. Pacing impedance at the 6 month visit is presented here.|6 month|Subjects with bipolar configuration pacing impedance at 6 month||Ohms||Standard Deviation|Mean
788970|NCT00853593|Secondary|Characterize Model 4396 Electrical Performance- Bipolar Configuration: Voltage Threshold|Bipolar voltage threshold at 0.5 ms was collected at implant, pre-hospital discharge and all scheduled follow-up visits. Voltage threshold at the 6 month visit is reported here.|6 month|Subjects with bipolar configuration threshold captured at 0.5 ms at 6 month||Volts||Standard Deviation|Mean
788971|NCT00853593|Secondary|Characterize Model 4396 Electrical Performance- Ring Electrode: Sensing|Ring electrode sensing, measured by R-wave amplitude, for the Model 4396 was collected only at the implant procedure because the devices allowed in this study are not programmable to collect sensing measurements using the ring electrode. The analyzer was used to collect measurements.|During implant procedure.|Subjects with ring electrode R-wave amplitude at implant||mV||Standard Deviation|Mean
788972|NCT00853593|Secondary|Characterize Model 4396 Electrical Performance- Ring Electrode: Pacing Impedance|Subjects' ring electrode pacing impedance was measured at implant, pre-hospital discharge and all scheduled follow-up visits. Pacing impedance at the 6 month visit is presented here.|6 month|Subjects with ring electrode pacing impedance at 6 month||Ohms||Standard Deviation|Mean
788973|NCT00853593|Secondary|Characterize Model 4396 Electrical Performance- Ring Electrode: Voltage Threshold|Ring electrode voltage threshold at 0.5 ms was collected at implant, pre-hospital discharge and all scheduled follow-up visits. Voltage threshold at the 6 month visit is presented here.|6 month|Subjects with ring electrode threshold captured at 0.5 ms at 6 month||Volts||Standard Deviation|Mean
788974|NCT00853593|Secondary|Characterize Model 4396 Electrical Performance- Tip Electrode: Sensing|Tip electrode sensing, measured by R-wave amplitude, for the Model 4396 was collected at implant, pre-hospital discharge and all scheduled follow-up visits. Measurements at the 6 month visit are presented here. Sensing is the minimum energy produced by the left ventricle of the heart that the device can sense.|6 month|Subjects with tip electrode R-wave amplitude at 6 month||mV||Standard Deviation|Mean
788975|NCT00853593|Secondary|Characterize Model 4396 Electrical Performance- Tip Electrode: Pacing Impedance|Subjects' tip electrode pacing impedance (a measure of electrical resistance) was measured at implant, pre-hospital discharge and all scheduled follow-up visits. Pacing impedance at the 6 month visit is presented here.|6 month|Subjects with tip electrode pacing impedance at 6 month||Ohms||Standard Deviation|Mean
788976|NCT00853593|Secondary|Characterize Model 4396 Electrical Performance- Tip Electrode: Voltage Threshold|Tip electrode voltage threshold at 0.5 ms was collected at implant, pre-hospital discharge and all scheduled follow-up visits. Voltage threshold values at the 6 month visit are summarized.|6 month|Subjects with tip electrode threshold captured at 0.5 ms at 6 month||Volts||Standard Deviation|Mean
788977|NCT00853593|Secondary|Efficacy: Bipolar Voltage Threshold|Subjects' voltage threshold in the bipolar configuration was collected at the one month visit. The Model 4396 was considered effective if the mean voltage threshold (at 0.5 milliseconds [ms]) is less than or equal to 4.0 Volts.|1 month|Subjects that were implanted with a Model 4396 lead and completed the 1 month visit||Volts||Standard Deviation|Mean
788978|NCT00853593|Secondary|Assessment of Lead Handling Characteristics Reported as Acceptable|Implant lead handling characteristics were qualitatively assessed through physician feedback on the Implant Case Report Form (CRF). Physicians were asked for their overall assessment of the lead and results were categorized as acceptable or unacceptable. The number of acceptable responses are summarized.|During implant procedure.|Subjects who underwent a Model 4396 left ventricular lead implant attempt.||participants|||Number
788979|NCT00853593|Secondary|Total Operation Time|Total operation time was defined as time from initial incision to final closure.|During implant procedure.|Subjects successfully implanted with a Model 4396 lead.||minutes||Standard Deviation|Mean
788980|NCT00853593|Secondary|Model 4396 Lead Placement Time|Model 4396 lead placement time was defined as the time from insertion of the successfully implanted lead to the time when it was placed in the first acceptable pacing location.|During implant procedure.|Subjects successfully implanted with a Model 4396 lead. Note that one subject's LV Lead placement time was permanently missing and a study deviation was reported.||minutes||Standard Deviation|Mean
788981|NCT00853593|Secondary|Fluoroscopy Time|The total time the fluoroscope was imaging (not including biplane fluoroscopy time).|During implant procedure.|Subjects successfully implanted with a Model 4396 lead. Note that one subject's standard fluoroscopy time was not collected and a study deviation was reported.||minutes||Standard Deviation|Mean
792229|NCT00879190|Primary|Treatment Success Defined as Resolution of Fever by 24 Hours Postpartum|Proportion of patients in each arm experiencing treatment success defined as resolution of fever by 24 hours postpartum|Up to 24 hours after delivery|||Participants|||Count of Participants
788983|NCT00853593|Secondary|Subjects Successfully Implanted With Any Medtronic Attain Family LV Lead|A successful implant occurs when any Medtronic Attain Family LV Lead is implanted in a left ventricular vein and functions appropriately. The Attain Family leads include the following models: 4193, 4194, 4195, 4196, and 4396.|During implant procedure.|Subjects who underwent an implant attempt.||participants|||Number
788984|NCT00853593|Secondary|Subjects Successfully Implanted With Any Transvenous LV Lead|A successful implant occurs when any transvenous LV lead is implanted in a left ventricular vein functions appropriately.|During implant procedure.|Subjects who underwent an implant attempt.||participants|||Number
788985|NCT00853593|Secondary|Subjects Successfully Implanted With Any Transvenous LV Lead After Cannulation|A successful implant after cannulation occurs when the coronary sinus (CS) is successfully cannulated and a left ventricular lead (any transvenous LV lead) is implanted in a left ventricular vein and functions appropriately. An implant attempt of any transvenous LV lead was defined as any time when a transvenous LV lead was introduced into the body.|During implant procedure.|Subjects with successful CS cannulation after an implant attempt.||participants|||Number
788986|NCT00853593|Secondary|Subjects Successfully Implanted With Model 4396 Lead|A successful implant occurs when the Model 4396 lead is implanted in a left ventricular vein and functions appropriately. A Model 4396 implant attempt was defined as any time when a Model 4396 lead was introduced into the body.|During implant procedure.|Subjects who underwent Model 4396 LV implant attempt.||participants|||Number
788987|NCT00853593|Primary|Efficacy: Proximal Ring Voltage Threshold|Subject's proximal ring electrode voltage threshold was collected at the three months visit. The Model 4396 was considered effective if the mean voltage threshold was less than 3.0 Volts.|Three months|Subjects with ring electrode threshold captured at 0.5 ms at 3-month||Volts||Standard Deviation|Mean
788988|NCT00853593|Primary|Efficacy: Distal Tip Electrode Voltage Threshold|Subjects' distal tip electrode voltage threshold was collected at the one month visit. The Model 4396 was considered effective if the mean voltage threshold was less than 3.0 Volts. Voltage threshold was collected using LV tip to Right Ventricular (RV) coil configuration at 0.5 milliseconds [ms]. Voltage threshold is the minimum energy required from the device to consistently pace the ventricle.|One month|Only subjects with pacing thresholds captured at 0.5 ms were included in the analysis.||Volts||Standard Deviation|Mean
788989|NCT00853593|Primary|Safety (Subjects Without a Model 4396 Lead Related Complication)|A subject who was free of a Model 4396 lead related complication by the one month visit. All adverse events (AE) in the time frame were recorded at the subject's center and assessed by a centralized Adverse Event Advisory Committee (AEAC). The AEAC determined whether an AE was a complication and whether the event was related to the Model 4396 lead. A complication is an AE that results in death, termination of significant device function or invasive intervention (any therapy that penetrates the skin including administration of intramuscular (IM) and parenteral (IV) fluids).|One month|Subjects who underwent a Model 4396 left ventricular (LV) lead implant attempt and had a 1 month follow-up visit.||participants|||Number
788990|NCT00853606|Primary|Change in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Score|Questionnaire assesses subject's evaluation of erectile function over the previous 4-week period. Total score from questions 1-5 & 15 ranges from 1 to 30. A higher score indicates better erectile function. Baseline is the observation at Visit 2 of the qualifying study (TA-301/TA-302). End of treatment is the observation at Visit 8 of the last observation carried forward.|Baseline, End of Treatment|Number of participants analyzed represents the Intent-to-Treat population. For dropouts of missing data, the last observation carried forward convention was used.||scores on a scale||Standard Deviation|Mean
788991|NCT00853606|Primary|Change in Percentage of Sexual Attempts in Which Subjects Were Able to Insert the Penis Into the Partner's Vagina|"Data presented as mean change from baseline and the treatment period in the percentage of Yes responses to Sexual Encounter Profile (SEP) diary question 2 Were you able to insert your penis into your partner's vagina? Baseline is the run-in period from the qualifying study (TA-301/TA-302) consisting of all data reported during the non-treatment interval from Visit 1 to Visit 2. The treatment period is the on-treatment interval beginning with the first dose of study drug and ending on the last study visit."|Baseline, 52 weeks|Number of participants analyzed represents to Intent-to-Treat population.||percentage of sexual attempts||Standard Deviation|Mean
788992|NCT00853606|Primary|Change in Percentage of Sexual Attempts in Which Subjects Were Able to Maintain an Erection of Sufficient Duration to Have Successful Intercourse.|"Data presented as mean change from baseline and the treatment period in the percentage of Yes responses to Sexual Encounter Profile (SEP) diary question 3 Did your erection last long enough for you to have successful intercourse? Baseline is the run-in period from the qualifying study (TA-301/TA-302) consisting of all data reported during the non-treatment interval from Visit 1 to Visit 2. The treatment period is the on-treatment interval beginning with the first dose of study drug and ending on the last study visit."|Baseline, 52 weeks|Number of participants analyzed represents the Intent-to-Treat population.||percentage of sexual attempts||Standard Deviation|Mean
788993|NCT00853658|Secondary|All Cause Death|Number of patients - All-cause death. All-cause death is common in Heart Failure HF patients this measures how many patients had this event.|up to end of study (78 months)|Full Analysis Set (FAS) - All randomized patients with exception of mis-randomized patients that took no study drug and patients from the sites with major GCP violations||participants|||Number
788994|NCT00853658|Secondary|Change From Baseline to Month 12 for the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score|Change from baseline to Month 12 for the Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score. KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. KCCQ clinical summary score is a composite assessment of physical limitations and total symptom scores. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.|Baseline, Month 12|Full Analysis Set (FAS) - All randomized patients with exception of mis-randomized patients that took no study drug and patients from the sites with major GCP violations.||KCCQ Score||Standard Error|Least Squares Mean
789027|NCT00853762|Primary|Change From Baseline in Vital Signs: Temperature||Baseline, Week 2, 4, 8, 12, 16, 20, 24 and 36|Double-blind safety analysis set included all the subjects who received at least 1 dose of trial medication in the ATAMS extension study. Here 'n' signifies those subjects who were evaluable for the specified category.||Degree Celsius||Standard Deviation|Mean
788995|NCT00853658|Primary|Number of Participants That Had First Occurrence of the Composite Endpoint, Which is Defined as Either Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization|Number of participants that had first occurrence of the composite endpoint, which is defined as either CV death or HF hospitalization due to HF.|up to End of Study (78 months)|Full Analysis Set (FAS) - All randomized patients with exception of mis-randomized patients that took no study drug and patients from the sites with major GCP violations.||participants|||Number
788996|NCT00853723|Secondary|Tubular Maximum for Phosphorous/Glomerular Filtration Rate (TMP/GFR)|"Fractional tubular reabsorption of phosphate (TRP) = 1-{(U phos/P phos) x ( P creat/U creat)} if TRP < or = 0.86 then TMP/GFR = TRP x P phos if TRP > 0.86 then TMP/GFR = 0.3 x TRP/{1-(0.8 x TRP)} x P phos
U= urine, P = plasma"|Baseline, Day 15, Day 30, Day 60, Day 90|||mg/dl||Standard Error|Mean
788997|NCT00853723|Secondary|Fractional Excretion of Calcium|(Serum Creatinine X Urine Calcium)/(Serum Calcium X Urine Creatinine)|Baseline, Day 15, Day 30, Day 60, Day 90|||% excreted||Standard Error|Mean
788998|NCT00853723|Secondary|1,25 Vitamin D||Baseline, Day 15, Day 30, Day 60, Day 90|||pg/ml||Standard Error|Mean
788999|NCT00853723|Secondary|24 Hour Urine Calcium||90 days|||mg/gm creatinine||Standard Error|Mean
789000|NCT00853723|Secondary|Serum Phosphorous||Baseline, Day 15, Day 30, Day 60, Day 90|||mg/dl||Standard Error|Mean
789001|NCT00853723|Secondary|Total Serum Calcium (mg/dl)||Baseline, Day 15, Day 30, Day 60, Day 90|||mg/dl||Standard Error|Mean
789002|NCT00853723|Secondary|Changes in Bone Mineral Density of the Distal 1/3 Radius.||90 days|||Percent change from baseline||Standard Error|Mean
789003|NCT00853723|Secondary|Changes in Bone Mineral Density of the Forearm.||90 days|||Percent change from baseline||Standard Error|Mean
789004|NCT00853723|Secondary|Changes in Bone Mineral Density of the Femoral Neck.||90 days|||Percent change from baseline||Standard Error|Mean
789005|NCT00853723|Secondary|Changes in Bone Mineral Density of the Total Hip.||90 days|||Percent change from baseline||Standard Error|Mean
789006|NCT00853723|Primary|Carboxy-terminal Telopeptides of Collagen-1 (CTX)||Baseline, Day 15, Day 30, Day 60, Day 90|||percentage change from baseline||Standard Error|Mean
789007|NCT00853723|Secondary|Changes in Bone Mineral Density of the Lumbar Spine.||90 days|||Percent change from baseline||Standard Error|Mean
789008|NCT00853723|Primary|Procallagen-1 Amino-terminal Peptide (P1NP)||Baseline, Day 15, Day 30, Day 60, Day 90|||percentage change from baseline||Standard Error|Mean
789009|NCT00853749|Other Pre-specified|Percentage of Participants Reporting Prespecified Systemic Reactions Within 4 Days of Vaccination|Pre-specified systemic events (any fever 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using a diary card. Participants may have been represented in more than 1 category.|Day 1 through Day 4|Safety; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the specific characteristic||Percentage of participants|||Number
789010|NCT00853749|Other Pre-specified|Percentage of Participants Reporting Prespecified Local Reactions Within 4 Days of Vaccination|Local reactions were reported by the parent/legal guardian using a diary card. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Particpants may have been represented in more than 1 category.|Day 1 through Day 4|Safety Population: all participants who receive at least 1 dose of the study vaccine; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the specific characteristic||Percentage of participants|||Number
789011|NCT00853749|Other Pre-specified|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody 1 Month After Vaccination|Antibody GMC as measured by mcg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. CIs were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. GMCs were calculated using all particpants with available data for the specified blood draw.|Day 28|Evaluable Immunogenicity Population; N=number of participants with a determinate antibody concentration to the specified serotype.||mcg/mL||95% Confidence Interval|Geometric Mean
789012|NCT00853749|Secondary|Antibody Response Measured 1 Month After Vaccination (OPA)|Antibody response as measured by OPA, 1 month after vaccination. Geometric mean titers (GMTs) calculated using all participants with available data for the specified blood draw. CIs were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|Day 28|Evaluable Immunogenicity Population; N=number of participants with a determinate antibody titre to the specified serotype.||GMT||95% Confidence Interval|Geometric Mean
789013|NCT00853749|Secondary|Antibody Response Measured 1 Month After Vaccination (Avidity Assay)|Avidity assay had measurable range of 0.117 to 7.5. Results expressed as avidity index (AI). Geometric mean avidity presented for 3 common pneumococcal serotypes (serotype 6B, 19F, and 23F) and 2 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1 and 5).|Day 28|Evaluable Immunogenicity Population; In accordance with the recommendation of the lab completing the assays, values above the upper limit were assigned a value of 8.0 and those below the lower limit were assigned a value of 0.10. N=number of participants with a determinate avidity index for the specified serotype.||AI||95% Confidence Interval|Geometric Mean
789014|NCT00853749|Primary|Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥ 1:8 Measured 1 Month After Vaccination|Percentage of participants achieving OPA along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.|Day 28|Evaluable Immunogenicity Population; N=number of participants with a determinate OPA antibody titer to the given serotype.||Percentage of participants||95% Confidence Interval|Number
789028|NCT00853762|Primary|Change From Baseline in Vital Signs: Pulse Rate||Baseline, Week 2, 4, 8, 12, 16, 20, 24 and 36|Double-blind safety analysis set included all the subjects who received at least 1 dose of trial medication in the ATAMS extension study. Here 'n' signifies those subjects who were evaluable for the specified category.||beats per minute (beats/min)||Standard Deviation|Mean
789015|NCT00853749|Primary|Percentage of Participants Achieving a Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to ( ≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After Vaccination|Percentage of participants achieving predefined antibody threshold ≥ 0.35 mcg/mL along with the corresponding 95 percent (%) Confidence Interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.|Day 28|Evaluable Immunogenicity Population: received 1 dose of 13vPnC at Visit 1, blood drawn within specified timeframes, at least 1 valid and determinate assay result at Visits 1 and 3, no major protocol violations, and no prohibited vaccines. N=number of participants with a determinate IgG antibody concentration to the given serotype.||Percentage of participants||95% Confidence Interval|Number
789016|NCT00853762|Primary|Number of Subjects With Positive Neutralizing Antibody (NAb)||Baseline, Week 12 and 36|Appropriate method/test was not established to identify the positive neutralizing antibodies for atacicept. Hence, this outcome measure was not assessed.|||||
789017|NCT00853762|Secondary|Pharmacogenetics/Pharmacogenomics Analysis|"Gene expression profiling and gene polymorphism identification were to be used to identify putative markers for response to treatment.
Genome-wide gene polymorphism characterization by genome-wide scan.
Targeted gene polymorphism identification of B-Lymphocyte Stimulator (BLyS) , APRIL, (receptor for B cell activating factor of the tumor necrosis factor [TNF] family) BAFF-R, (Transmembrane Activator) TACI and (B Cell Maturation Antigen) BCMA and HLA-DRB1 by direct genotyping or sequencing ."|Day 1 and Week 36|Genetic/genomic analysis was not performed as the trial was terminated early.|||||
789018|NCT00853762|Secondary|Free B-Lymphocyte Stimulator (BLyS) and Free A Proliferation-Inducing Ligand (APRIL) Serum Concentrations.|Levels of free APRIL and free BLyS: Free APRIL serum samples were to be analyzed by using a validated enzyme-linked immunosorbent assay (ELISA) with limits of detection of 0.3125 nanogram per milliliter (ng/mL) for free APRIL and free BlyS serum samples were analysed using a validated ELISA with limits of detection of 1.56 ng/mL.|Baseline, Week 12 and 36|This outcome measure was not assessed due to lack of a valid assay for measuring BLyS and APRIL.|||||
789019|NCT00853762|Secondary|Concentrations of Free and Total Atacicept||Baseline and Week 12|This outcome measure was not assessed due to lack of a valid assay during the usable time period of the samples.|||||
789020|NCT00853762|Secondary|Magnetic Resonance Imaging (MRI) Parameters: Volume of T2 Lesions (New or Enlarging T2 Lesions) Per Subject||Baseline, Week 12 and Week 24|||Cubic millimeter||Standard Deviation|Mean
789021|NCT00853762|Secondary|Magnetic Resonance Imaging (MRI) Parameters: Number of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject||Baseline, Week 12 and 24|Intent-to-treat (ITT) population included all randomized subjects. “n” signifies the number of evaluable subjects for this outcome measure.||Number of lesions per subject||Standard Deviation|Mean
789022|NCT00853762|Secondary|Change in Multiple Sclerosis Functional Composite (MSFC) Score at Week 12|The MSFC is a multidimensional clinical outcome measure which consists of three sub-tests; Timed 25-Foot Walk, 9-Hole Peg Test and Paced Auditory Serial Addition Test-3(PASAT-3). The Timed 25-Foot Walk is a quantitative measure of lower extremity function. The 9-Hole Peg Test is a quantitative measure of upper extremity (arm and hand) function. The PASAT is a measure of cognitive function that specifically assesses auditory information processing speed and flexibility, as well as calculation ability. Standardized results (Z-scores) of these sub-tests and the overall MSFC Z-score as an average of these three Z-scores was calculated. Higher Z-scores reflect better neurological function and a positive change from baseline indicates improvement. An increase in score indicates an improvement (range -3 to +3).|Week 12|"Intent-to-treat (ITT) population included all randomized subjects. N signifies number of evaluable subjects for this outcome measure."||z-score||Standard Deviation|Mean
789023|NCT00853762|Secondary|Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at Week 12|EDSS is an ordinal scale in half-point increments that qualifies disability in participants with multiple sclerosis (MS). It assesses the 8 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder, cerebral and other) as well as ambulation. EDSS overall score ranging from 0 (normal) to 10 (death due to MS) was calculated.|Baseline, Week 12|"Intent-to-treat (ITT) population included all randomized subjects. N signifies (total number of subjects analyzed) the number of evaluable subjects for this outcome measure."||Units on a scale||Standard Deviation|Mean
789024|NCT00853762|Secondary|Number of Subjects With Clinical Attacks/Relapses|"A clinical attack/relapse was defined as the fulfillment of all the following criteria:
Neurological abnormality, either newly appearing or re-appearing, with abnormality specified by both i) neurological abnormality separated by at least 30 days from onset of a preceding clinical event, and ii) neurological abnormality lasting for at least 24 hours.
Absence of fever or known infection (fever with temperature (axillary, orally, or intra-auriculary) > 37.5°C/99.5 °Fahrenheit).
Objective neurological impairment, correlating with the subject’s reported symptoms, defined as either i) increase in at least 1 of the functional systems of the Expanded Disability Status Scale (EDSS), or ii) increase of the total EDSS score. EDSS overall score ranging from 0 (normal) to 10 (death due to MS) was calculated."|Baseline up to Week 24|Intent-to-treat (ITT) population included all randomized subjects.||Subjects|||Number
789025|NCT00853762|Primary|Number of Subjects With Worsened Post Baseline Shift in Immunoglobulin A (IgA), IgG and IgM Levels|Number of subjects with shifts from normal Grade (Grade 0) at Baseline to worse value at post-baseline (Grade 1 to Grade 4) according to the following criteria: IgA Grade 0: greater than or equal to (>=) lower limit normal (LLN) 0.7 gram per liter (g/L); Grade 1: less than (<) LLN - 0.5 g/L, Grade 2: <0.5g/L -0.3 g/L, Grade 3: <0.3 g/L -0.1 g/L, Grade 4: < 0.1 g/L; IgG Grade 0: >= LLN (7 g/L), Grade 1: < LLN - 5 g/L, Grade 2: <5g/L -4 g/L, Grade 3: <4 g/L -3 g/L and Grade 4: < 3 g/L; IgM Grade 0: >= LLN (0.4 g/L), Grade 1: < LLN - 0.3 g/L, Grade 2: <0.3 g/L -0.2 g/L, Grade 3: <0.2 g/L -0.1 g/L, and Grade 4: < 0.1 g/L are presented in this outcome measure.|Baseline up to Week 36|Intent-to-treat (ITT) population included all randomized subjects.||Subjects|||Number
789026|NCT00853762|Primary|Change From Baseline in Electrocardiogram (ECGs)||Baseline, Week 12 and 36|No summary tables were prepared for ECG parameters, and ECG data were not formally analyzed. However, a qualitative assessment of ECG morphology and rhythm was made by the Investigator and recorded in the electronic case report form (eCRF). ECG abnormalities considered significant by the investigator were reported as AEs.|||||
789029|NCT00853762|Primary|Change From Baseline in Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Blood pressure (systolic and diastolic) was measured after at least 3 minutes resting, with the subject in the seated position.|Baseline, Week 2, 4, 8, 12, 16, 20, 24 and 36|Double-blind safety analysis set included all the subjects who received at least 1 dose of trial medication in the ATAMS extension study. Here 'n' signifies those subjects who were evaluable for the specified category.||millimeter of mercury (mmHg)||Standard Deviation|Mean
789030|NCT00853762|Primary|Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Injection Site Reactions, Infections, and Malignancies by Severity|TEAEs were defined as AEs with a start date after or on the date of the first DB treatment injection in ATAMS Extension and that occurred anytime after treatment discontinuation, or up to the day before first Rebif® rescue medication injection in ATAMS Extension. A serious TEAE was an AE that resulted in any of the following: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAE severity was graded as per Qualitative Toxicity Scale. Local injection site reactions (injection site: pain, redness, itching and swelling) throughout ATAMS Extension, starting after the first trial medication administration. If the subject experienced 1 or more of the above injection site symptoms, these were reported with the AE verbatim term “injection site reaction”. For all randomized subjects, there was an option of rescue treatment with Rebif® for 1 year beginning with the first injection of Rebif®).|From the first dose of study drug administration up to Week 24|Double-blind safety analysis set included all the subjects who received at least 1 dose of trial medication in the ATAMS extension study.||Subjects|||Number
789031|NCT00853827|Secondary|Number of Patients With Adverse Events, Serious Adverse Events, and Death|overall safety and tolerability of aliskiren 300 mg compared to placebo in patients with CAD and BP in the pre-hypertensive (high normal) range with or without treatment for hypertension following 104 weeks of treatment. Any Adverse Event was defined as occurrence of any symptom regardless of intensity grade, Serious Adverse Event (SAEs) assessed as medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in persistent or significant disability/incapacity.|104 weeks|Safety - All patients who received at least one dose of double-blind trial medication. Patients were analyzed according to the treatment that they received||Number of patients|||Number
789032|NCT00853827|Secondary|Patients That Demonstrated Evidence of Atheroma Regression|Atheroma regression is defined as change from baseline to endpoint in PAV <0 .|Baseline to endpoint (104 weeks)|Full Analysis Set (FAS) - All randomized patients. Patients were analyzed according to the treatment that they were assigned at randomization||Participants|||Number
789033|NCT00853827|Secondary|Change in Normalized Total Atheroma Volume (TAV) as Assessed by IVUS|Change from baseline in normalized total atheroma volume (TAV) (mm^3) for all matched slices of anatomically comparable segments of the target coronary artery were assess by IVUS after 104 weeks of treatment. calculation for change is the value at the later time point minus the value at the earlier time point, with positive numbers to represent increases and negative numbers to represent decreases|Baseline, 104 weeks|Full Analysis Set (FAS) - All randomized patients. Patients were analyzed according to the treatment that they were assigned at randomization. All patients who had a valid baseline and post baseline IVUS measurement and post-baseline IVUS measurement and at least ≥72 weeks of treatment were included in this analysis.||mm^3||Standard Error|Least Squares Mean
789034|NCT00853827|Primary|Change From Baseline in Percent Atheroma Volume(PAV) After 104 Weeks of Treatment|Change from baseline in PAV for all matched slices of anatomically comparable segments of the target coronary artery were assessed by intravascular ultrasound (IVUS) evaluation after 104 weeks of treatment . calculation for change is the value at the later time point minus the value at the earlier time point, with positive numbers to represent increases and negative numbers to represent decreases|Baseline, 104 weeks|Full Analysis Set (FAS) - All randomized patients. Patients were analyzed according to the treatment that they were assigned at randomization. All patients who had a valid baseline and post baseline IVUS measurement and post-baseline IVUS measurement and at least ≥72 weeks of treatment were included in this analysis.||percentage of baseline||Standard Error|Least Squares Mean
789035|NCT00853840|Secondary|Number of Subjects With Postural Hypotension|Postural (orthostatic) hypotension defined as 1) decrease in standing-supine diastolic blood pressure (BP) greater than or equal to 10 mm Hg; 2) decrease in standing-supine systolic BP greater than or equal to 20 mm Hg; or 3) standing systolic BP less than 90 mm Hg. Assessed at Period 1 and Period 2 BP measurement timepoints post maraviroc dose.|Period 1 and Period 2 (up to 8 days)|The vital sign analysis population was defined as all enrolled subjects who received at least 1 dose of study medication and had at least 1 vital sign parameter in at least 1 treatment period.||participants|||Number
789036|NCT00853840|Secondary|Postural Changes in Pulse Rate|Postural change calculated as position 1 (standing) value minus position 2 (supine) value. Baseline was the average of the 3 predose measurements at each period. Means of Replicates were used in calculations.|Baseline, 6 and 12 hours post dose on Day 1 from the First Day of each Treatment Leg|The vital sign analysis population was defined as all enrolled subjects who received at least 1 dose of study medication and had at least 1 vital sign parameter in at least 1 treatment period.||beats per minute (bpm)||Standard Deviation|Mean
789037|NCT00853840|Secondary|Postural Changes in Systolic and Diastolic Blood Pressure|Postural change calculated as position 1 (standing) value minus the position 2 (supine) value. Baseline was the average of 3 predose measurements at each period. Means of replicates were used in calculations.|Baseline, 6 and 12 hours post dose on Day 1 from the First Day of each Treatment Leg|The vital sign analysis population was defined as all enrolled subjects who received at least 1 dose of study medication and had at least 1 vital sign parameter in at least 1 treatment period.||mm Hg||Standard Deviation|Mean
789038|NCT00853840|Secondary|Standing and Supine Pulse Rate|Supine pulse rate measurement was taken after subject rested for 5 minutes supine. Subject sat for 2 minutes, then stood for 2 minutes and standing measurement taken. Duplicate supine and standing pulse rate measurements taken per protocol. Average of duplicate measurements calculated prior to data analysis.|1.5, 2, 2.5, 3, 4, 6, 8, 12 hours post Vardenafil or Placebo dose|The vital sign analysis population was defined as all enrolled subjects who received at least 1 dose of study medication and had at least 1 vital sign parameter in at least 1 treatment period.||beats per minute (bpm)||Standard Error|Least Squares Mean
789039|NCT00853840|Primary|Standing and Supine Systolic and Diastolic Blood Pressure (BP)|Supine BP was taken after subjects rested for 5 minutes supine. Subjects then sat for 2 minutes and stood for 2 minutes then standing BP taken. Duplicate supine and standing BP measurements were taken per the protocol. The average of the duplicate measurements was calculated prior to data analysis.|1.5, 2, 2.5, 3, 4, 6, 8, 12 hours post Vardenafil or Placebo dose|The vital sign analysis population was defined as all enrolled subjects who received at least 1 dose of study medication and had at least 1 vital sign parameter in at least 1 treatment period.||mm Hg||Standard Error|Least Squares Mean
789040|NCT00853905|Secondary|Ocular Hypotensive Medications||Ocular medications will be documented during the 1 day, 1 week, 1 month, 3 month, and or 6 month post-operative period||||||
789041|NCT00853905|Secondary|A Patient Comfort Questionnaire|Dry Eye Scores were lower in the treatment group at 1 month|Patients will be quiered at 1 day, 1 week, 1 month, 3 month and 6 month post-op visit||||||
789042|NCT00853905|Secondary|Bleb Morphology Graded by Indiana Bleb Appearance Grading Scale (IBAGS) and the Moorfields Bleb Grading System (MBGS)|Bleb appearance is grading using the Moorfields bleb grading system IBAGS; anterior segment slit lamp photos were also done|IBAGS assessed at 1 day, 1 week, 1 month, 3 month and 6 month post-op visits; Moorfields Bleb Grading will be done at 1 month, 3 month, and 6 month post-op visits||||||
789043|NCT00853905|Secondary|A Kowa FM-500 Flare Meter is Used to Measure Inflammation in the Anterior Chamber|Anterior chamber inflammation measurement is taken 10 times using the Kowa FM-500 flare meter per eye|Data collected 1 month, 3 month and 6 month post-op visits||||||
789044|NCT00853905|Primary|Intraocular Pressure (IOP)|patient failed the study if IOP was less than 5mmhg for starting IOP or less than a 20% decrease in IOP|Data collected Baseline (before Surgery), 1 day, 1week, 1 month, 3 month and 6 month post-op visits|||mm Hg||95% Confidence Interval|Mean
789045|NCT00853957|Secondary|Percentage of Patients With Peripheral Edema by Visit|Cumulative percentage of patients with peripheral edema was calculated. 'Cumulative' refers to patients with peripheral edema before or at the corresponding visit. If peripheral edema occurred more than once, only the first occurrence was counted. Peripheral edema is the swelling of tissues due to the accumulation of fluids. Peripheral edema was assessed by investigators during physical examination.|8 weeks|Full Analysis Set||Percentage of participants|||Number
789046|NCT00853957|Secondary|Change From Baseline in MSSBP at Week 1 and 4|Compare the change from baseline in MSSBP at week 1 and 4|Baseline, 1 and 4 weeks|Full analysis set, Last Observation Carried Forward (LOCF)||mm Hg||Standard Deviation|Mean
789047|NCT00853957|Secondary|Percentage of Responders (Patients With MSSBP < 140 mmHg or Decrease From Baseline of Greater Than or Equal to 20 mmHg)|Cumulative percentage of responders (Responders are defined as patients with MSSBP <140 mmHg or a decrease from baseline ≥20 mmHg) during 8 weeks of treatment was calculated. Cumulative refers to achieving blood pressure control before or at the corresponding visit. If achieving blood pressure control occurred more than once, only the first occurrence was counted.|8 weeks|Full analysis set||Percentage of participants|||Number
789048|NCT00853957|Secondary|Percentage of Patients Achieving Blood Pressure (BP) Control (<140/90 mmHg)|Cumulative percentage of patients achieving BP control (<140/90 mmHg)for both treatment arms was calculated. Cumulative refers to achieving blood pressure control before or at the corresponding visit. If achieving blood pressure control occurred more than once, only the first occurrence was counted.|8 weeks|Full analysis set||Percentage of participants|||Number
789049|NCT00853957|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)|To compare the change from baseline in mean sitting diastolic blood pressure (msDBP) after 8 weeks of treatment with a combination of aliskiren and amlodipine treatment regimen (150/5 mg, 300/10 mg) versus an amlodipine treatment regimen (5 mg, 10 mg).|Baseline, 8 weeks|Full analysis set, Last Observation Carried Forward (LOCF)||mm Hg||Standard Deviation|Mean
789050|NCT00853957|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)|To compare the change from baseline in mean sitting systolic blood pressure (msSBP) after 8 weeks of treatment with a combination of aliskiren and amlodipine treatment regimen (150/5 mg, 300/10 mg) versus an amlodipine treatment regimen (5 mg, 10 mg) in African American patients with Stage 2 hypertension.|Baseline, 8 weeks|Full analysis set, Last Observation Carried Forward (LOCF)||mm Hg||Standard Deviation|Mean
789051|NCT00853970|Secondary|Pain Free|Participants that are pain free at day 1, taken from patient questionnaire with multiple possible responses measured on a scale of 0-3, where 0=none and 3=severe.|Day 1|Last observation carried forward (LOCF) Analysis, Intent to treat (ITT) Population||participants|||Number
789052|NCT00853970|Primary|Summed Ocular Inflammation Score (SOIS) of Zero|Participants with SOIS of 0. Measured on a scale of 0-4: 0=0 cells (complete absence); 0.5=1-5 cells ; 1=6-15 cells (very slight); 2=16-25 cells (moderate); 3=26-50 cells (marked); 4=>50 cells (intense)|Day 15 (Primary Endpoint)|Last observation carried forward (LOCF) Analysis; Intent to treat (ITT) Population||participants|||Number
789053|NCT00853996|Secondary|Reports of Muscle/Joint Complaints as Assessed by the Validated HAQ II Questionnaire|"The Health Assessment Questionnaire II (HAQ-II) measures interference in daily activities from arthralgias and joint pain. Range 0 - 4. A higher score indicates greater (i.e., worse) interference."|Baseline to up to 2 weeks post-treatment|||Participants|||Count of Participants
789054|NCT00853996|Secondary|Reports of Hot Flashes as Assessed by the Loprinzi Hot Flash Scoring System|Problems with hot flashes were assessed by average number per day and intensity.|Baseline to up to 2 weeks post-treatment|||Participants|||Count of Participants
789055|NCT00853996|Secondary|Change in Serum Concentration of Testosterone|Change in serum concentration of Testosterone from baseline to 6 months|Baseline to 6 months|||ng/ml||Standard Deviation|Mean
789056|NCT00853996|Secondary|Change in Serum Concentration of Bioavailable Estradiol|Change in serum concentration of bioavailable estradiol (adjusted for concentration of Sex Hormone Binding Globulin), from baseline to 6 months|Baseline to 6 months|||pM||Standard Deviation|Mean
789057|NCT00853996|Secondary|Change in Serum Estradiol Concentration|Change in serum concentration of estradiol from baseline to 6 months|Baseline to 6 months|||ng/ml||Standard Deviation|Mean
789058|NCT00853996|Secondary|Change in Mammographic Breast Density|Change in mammographic density from baseline to 6 months, The Percent Breast Density is estimated using the Cumulus computer-assisted program to define a region that is at greater density than the remainder of the breast.|Baseline to 6 months|One subject was without a digital file due to technical reasons. Thus, only 24 subjects were evaluated.||percentage of area at increased density||Inter-Quartile Range|Median
789060|NCT00854087|Primary|Efficacy of Fuzheng Huayu Treatment in Chronic Hepatitis C Subjects Who Have Failed Prior Anti-HCV Therapy or Cannot Receive or Refused Interferon Based Therapy.|"Efficacy of Fuzheng Huayu treatment was assessed through the change in liver fibrosis stage from the assessment before (pre) and after (post) study drug. The liver fibrosis staging system used was the Ishak scale. The Ishak liver fibrosis score ranges from 0 indicating no fibrosis to 6 indicating cirrhosis.
Fibrosis improved was defined as a lower post study drug Ishak score, by at least 1 point, from pre-study drug assessment of the liver fibrosis e.g. if a pre study drug Ishak score of 4 and then a post study drug Ishak score of 3 or lower.
Fibrosis did not change was defined as having the same Ishak score before and after study drug assessments e.g. if a pre study drug Ishak score of 4 and then a post study drug Ishak score of 4.
Fibrosis worsened was defined as a higher post study drug Ishak score, by at least 1 point, from pre-study drug assessment of the liver fibrosis e.g. if a pre study drug Ishak score of 4 and then a post study drug Ishak score of 5 or higher."|Baseline to Week 48|Participants who at least took one dose of study drug (Fuzheng Huayu or Placebo), were more than 80% compliant with study drug and had a pre and post study drug biopsy with an evaluable Ishak fibrosis score. Participants had ALT <300 and a BMI <40.||participants|||Number
789061|NCT00854087|Primary|Safety of Fuzheng Huayu Treatment in Chronic Hepatitis C Subjects Who Have Failed Prior Anti-HCV Therapy or Cannot Receive or Refused Interferon Based Therapy.|Safety will be evaluated through the changes in vital signs, physical examinations, adverse events, concomitant medication assessments as well as laboratory tests.|Baseline to Week 60||||||
789062|NCT00854113|Primary|VZ/F|Pharmacokinetic results. Apparent volume of distribution|Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days|||Liters||Standard Deviation|Mean
789063|NCT00854113|Primary|CL/F|Pharmacokinetics results. Apparent oral clearance|Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days|||L/hr||Standard Deviation|Mean
789064|NCT00854113|Primary|Terminal Rate Constant.|Pharmacokinetics results. Terminal rate constant was estimated by linear regression of logarithmic transformed concentration versus time data|Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days|||L/hr||Standard Deviation|Mean
789065|NCT00854113|Primary|AUC 0 -24|Pharmacokinetics results. Area under the plasma concentration-time curve from time 0 to 24 hours post-dose.|Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days|||ng*hr/ml||Standard Deviation|Mean
789066|NCT00854113|Primary|t1/2|Pharmacokinetics results.t 1/2 - apparent terminal half life|Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days|||hour||Standard Deviation|Mean
789067|NCT00854113|Primary|AUC 0-t|Pharmacokinetics results. AUC 0-t - Are under plasma concentration-time curve from time 0 time t.|Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days|||ng*hr/ml||Standard Deviation|Mean
789068|NCT00854113|Primary|Tmax|Pharmacokinetics results. Time to maximum plasma drug concentration (Tmax) was calculated for each groups|Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days|||hour||Full Range|Median
789069|NCT00854113|Primary|Cmax|Pharmacokinetics results. Cmax -Maximum plasma drug concentration|Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days|||ng/ml||Standard Deviation|Mean
789070|NCT00859833|Primary|Myocardial Perfusion Reserve Measured by Quantitative Perfusion MRI (Ratio of Myocardial Blood Flow During Stress Over Myocardial Blood Flow at Rest)|The ratio of myocardial blood flow during stress (with each vasodilator) divided by the myocardial flood flow at rest = myocardial perfusion reserve (MPR)|2 hours|Analysis was per protocol. All patients with analyzable data were included. 2/30 patients had technical problems with the MRI data that made their data unable to be analyzed.||ratio||Standard Deviation|Mean
789071|NCT00859898|Secondary|Number of Participants With Marked Laboratory Abnormalities in Liver Function in 24 Week Double Blind Treatment Period, Including Data After Rescue - Randomized, Treated Participants|Safety laboratory measurements were obtained during the Qualification and Lead-In Periods and on Day 1 of the Double-Blind Period and at Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24. BL was defined as the last assessment prior to the start of the first dose of the double-blind study medication. Data included from BL up to and including the last day of treatment plus 30 days. Liver function abnormality criteria: FDA Guidance for Industry: Premarketing Clinical Evaluation (July 2009). Data after rescue was also included. Abbreviations: Pretreatment (PreRX), upper limit of normal (ULN); greater than (>) less than (<); Units per liter (U/L), alanine aminotransferase (ALT); aspartate aminotransferase (AST); alkaline phosphatase (ALP). Marked abnormality Low (High) defined: ALP, AST and ALT (>3*ULN); bilirubin (>2*ULN if PreRX <= ULN; >3*ULN if PreRX > ULN); AST or ALT plus (+) bilirubin elevation: AST or ALT >3*ULN and bilirubin >1.5*ULN within 14 days on or after ALT elevation.|Baseline to Week 24/end of treatment plus 30 days|||participants|||Number
789072|NCT00859898|Secondary|Number of Participants With Marked Laboratory Abnormalities (Not Including Liver Function) in 24 Week Double Blind Treatment Period, Including Data After Rescue - Randomized, Treated Participants|Laboratory samples: Qualification and Lead-In Periods, Day 1, Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 of Double-Blind Period. Baseline (BL)=last assessment prior to start of first dose of double-blind study medication. Data after rescue included. Pretreatment (PreRX); grams per deciliter (g/dL); upper limit of normal (ULN); milliequivalent per liter (mEq/L); Units per liter (U/L), blood urea nitrogen (BUN). Marked abnormality Low (High) defined: hemoglobin <6 (>18 females or >20 males) g/dL; hematocrit <20% ( >55% females or >60% males); creatinine (>=1.5*preRX, >=2.5 mg/dL); glucose <54 (>350) mg/dL; creatine kinase (>5*ULN);calcium <7.5 (>=1 mg/dL from ULN and >= 0.5mg/dL from PreRX); sodium <130 or < 120 male/female (>150 mEq/L; potassium <=2.5 (>=6.0) mEq/L; bicarbonate <= 13 mEq/L; inorganic phosphorus: <=1.8 if age 17-65 or <=2.1 if age >=66, (>=5.6 if age 17-65 or >=5.1) mg/dL if age >=66; albumin <=2 (>6) g/dL; urine albumin(alb) / creatinine (creat) ratio (>1800 mg/g)|Baseline to Week 24/end of treatment plus 4 days|N=number of participants who took at least 1 dose of double-blind study medication, with non missing baseline and Week 24 values.||participants|||Number
789073|NCT00859898|Secondary|Number of Participants With Normal or Abnormal Electrocardiogram Summary Tracing at Week 24 (LOCF) - Randomized, Treated Participants|12-Lead electrocardiograms (ECGs) were performed at entry into Lead-In Period Day -7 visit and Week 24/End of treatment visit (last observation carried forward) on participants who were supine. ECGs were assessed by the investigator. Baseline (BL) was Day -7 for this parameter. Data after rescue included.|Week 24|||participants|||Number
789074|NCT00859898|Secondary|Mean Change From Baseline in Seated Heart Rate at Week 24 - Randomized, Treated Participants|Measurements were taken during the Qualification and Lead-In Periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 in the Double Blind Period. Heart rate values were obtained: after the participant was seated quietly for 5 minutes; at least 8 hours after the last ingestion of caffeine, alcohol, or nicotine; and in the same arm (right or left) consistently throughout the study. Heart rate was measured in beats per minute (bpm). Data after rescue were also included. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.|Week 24|N=number of participants who took at least 1 dose of double-blind study medication, with non missing baseline and Week 24 values.||bpm||Standard Error|Mean
789075|NCT00859898|Secondary|Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure at Week 24 - Treated Participants|Measurements were taken during the Qualification and Lead-In Periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 in the Double Blind Period. Blood pressure values were obtained: after the participant was seated quietly for 5 minutes; at least 8 hours after the last ingestion of caffeine, alcohol, or nicotine; and in the same arm (right or left) consistently through out the study. Systolic and Diastolic pressures were measured in millimeters of mercury (mmHg). Data after rescue were also included. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.|Week 24|N=number of participants who took at least 1 dose of double-blind study medication, with non missing baseline and Week 24 values.||mmHg||Standard Error|Mean
789076|NCT00859898|Secondary|Number of Participants With Adverse Events of Special Interest During the 12 Week Double Blind Period - All Treated Participants|Participants with AEs of hypoglycemia, cardiac/vascular disorders, renal impairment or failure, volume depletion (hypotension/dehydration/hypovolemia), fractures, urinary stones, and other reports suggestive of genital infection or urinary tract infection (UTI) were summarized using MedDRA version 13.0. Data after rescue included for all special AEs except hypoglycemia (excluded data after rescue). Major hypoglycemic episode: symptomatic requiring 3rd party assistance due to severe impairment in consciousness or behavior with a glucose value < 54 mg/dL and prompt recovery after glucose/glucagon; Minor: either symptomatic with glucose measurement < 63 mg/dL, regardless of need for 3rd party assistance, or asymptomatic with glucose < 63 mg/dL that does not qualify as major; Other: suggestive but not meeting criteria for major or minor.|Baseline to last dose plus 4 days in 12 Week Double Blind Period|Randomized participants who received at least one dose of study medication in the double-blind period. Data after rescue included for all AEs except hypoglycemia, which excluded data after rescue.||participants|||Number
789077|NCT00859898|Secondary|Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Discontinuation Due to AEs, During the 12 Week Double Blind Period, Including Data After Rescue - All Treated Participants|Medical Dictionary for Regulatory Activities (MedDRA), version 12.1 AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug as per the investigator. Events captured from baseline to last dose plus 4 days for AEs, plus 30 days for SAEs during the Double Blind 12 Week Period. Data after rescue included.|Day 1 of Double Blind Period to end of Week 24 Plus 30 days|Participants who received at least 1 dose of double-blind study medication during the double-blind treatment period. Data after rescue were also included.||participants|||Number
789078|NCT00859898|Secondary|The Adjusted Mean Change From Baseline in Total Body Weight at Week 24 (LOCF) - Randomized, Treated Participants|Adjusted mean change from baseline in total body weight at Week 24 (or the last post-baseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight was measured in kilograms (kg). Body weight measurements were obtained during the Qualification and Lead-In Periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 of the Double-Blind Period.|Week 24|N= Number of randomized participants, who took at least 1 dose of double-blind study medication, with non missing baseline and Week 24 (LOCF) values.||kg||Standard Error|Mean
789079|NCT00859898|Secondary|Adjusted Mean Change From Baseline in HbA1C at Week 24 (LOCF) in Participants Whose Baseline HbA1C Category ≥9.0%|HbA1c was measured as percent of hemoglobin by a central laboratory. The population included those randomized, treated participants whose Baseline HbA1c was greater than, equal to (>=) 9.0%. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.|Week 24|N= Number of randomized participants, who took at least 1 dose of double-blind study medication, with non missing baseline and Week 24 (LOCF) values, whose baseline HbA1c was >=9.0%.||Percent of Hemoglobin||Standard Error|Mean
789080|NCT00859898|Secondary|Percent Adjusted for Baseline HbA1c of Participants Achieving a Therapeutic Glycemic Response at Week 24 (LOCF) - Randomized, Treated Participants|Therapeutic glycemic response was defined as HbA1c less than 7.0%. n=Number of participants with HBA1c less than (<) 7 % at Week 24, last observation carried forward (LOCF) while N=number of randomized participants with non-missing baseline and Week 24 (LOCF) values. Percent=n/N and was adjusted for Baseline HbA1c. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.|Week 24|N=number of randomized participants with non-missing baseline and Week 24 (LOCF) values; N=202, 216, 203, respectively. n=number of responders: 92, 69, 72, respectively. n/N=percent. Percent is then adjusted for baseline HbA1c.||Percent of participants||95% Confidence Interval|Number
789081|NCT00859898|Secondary|Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (LOCF) - Randomized, Treated Participants|Data after rescue medication was excluded from this analysis. FPG was measured as milligrams per deciliter (mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained during the Qualification and Lead-In Periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 of the Double-Blind Period.|Week 24|Number analyzed = Number of randomized participants, who took at least 1 dose of double-blind study medication, with non missing baseline and Week 24 (LOCF) values.||mg/dL||Standard Error|Mean
789082|NCT00859898|Primary|Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 (Last Observation Carried Forward) - Randomized Treated Participants|Adjusted mean change in HbA1c from baseline at Week 24 (or the last post-baseline measurement prior to Week 24 if no Week 24 assessment was available, ie, last observation carried forward (LOCF) was determined. HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the Qualification and Lead-In Periods and on Day 1 and Weeks 4, 8, 12, 16, 20, and 24 in the Double-Blind Period.|Week 24|N= Number of randomized participants, who took at least 1 dose of double-blind study medication, with non-missing baseline and Week 24 (LOCF) values.||Percent of hemoglobin||Standard Error|Mean
789083|NCT00859937|Secondary|Changes in Laboratory Correlates|Changes in laboratory correlates pre-post therapy will be analyzed using paired t-tests. The association between RET gene rearrangements/mutations and tumor response, as well as the association between germ-line polymorp response, will be analyzed using Fisher's exact test. The correlative and genetic data will also be entered as cova only due to the small sample size) in a Cox regression model of progression-free survival.|Baseline and 4 weeks|Biomarkers not done due to insufficient clinical responses thus making the biomarker analysis scientifically untenable.|||||
789084|NCT00859937|Secondary|Overall Survival|Kaplan-Meier curves will be generated and 90% confidence intervals will be derived.|Up to 5 years|There are two subtype cohorts, adenoid cystic carcinoma and non adenoid cystic carcinoma of malignant salivary gland tumors, with the same treatment. The two groups were analyzed separately and therefore no comparisons are made between the two groups.||months||90% Confidence Interval|Median
789085|NCT00859937|Primary|Progression-free Survival|Progression-free survival from start of treatment to the time of disease progression or death from any cause was estimated using the Kaplan-Meier method.|up to 5 years|There are two subtype cohorts, adenoid cystic carcinoma and non adenoid cystic carcinoma of malignant salivary gland tumors, with the same treatment. The two groups were analyzed separately and therefore no comparisons are made between the two groups.||months||90% Confidence Interval|Median
789086|NCT00859937|Primary|Response Rate|Response rate is percentage of the best overall response which recoded from the start of the treatment until diseases progression/recurrence. Response criteria are defined using the international criteria proposed by the Response Evaluation Criteria In Solid Tumors (RECIST) Committee: Complete Response, Disappearance of all target lesions; Partial Response, >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease, neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, no occurrence of progression disease for non-target lesions, and no new lesions.|Up to 2 months|There are two subtype cohorts, adenoid cystic carcinoma and non adenoid cystic carcinoma of malignant salivary gland tumors, with the same treatment. The two groups were analyzed separately and therefore no comparisons are made between the two groups.||participants|||Number
789087|NCT00859950|Primary|ODI|The oxygen desaturation index (ODI) is the number of times per hour of sleep that the blood's oxygen level drop by a certain degree from baseline.|Day 1 (all subjects)|||events/hour||Standard Deviation|Mean
789088|NCT00860028|Secondary|Number of Participants Who Reported an Adverse Event in the Varenicline Pretreatment Versus Placebo Pretreatment Conditions|Compares the number of participants who reported an adverse event in the extended varenicline pretreatment versus short-term varenicline pretreatment conditions during the 3-week placebo controlled pretreatment phase|First 3 weeks (pretreatment)|All participants were included in the analysis, assuming an intention to treat method.||Number of participants|||Number
789089|NCT00860028|Primary|Mean Percentage of Heavy Drinking Days Comparing Participants in the Extended Varenicline Pretreatment Versus Short-term Varenicline Pretreatment Conditions|Compares the mean percentage of heavy drinking days over the 3-week placebo-controlled pretreatment phase comparing participants in the extended varenicline pretreatment versus the short-term varenicline pretreatment conditions. Heavy drinking defined as consuming 4 or more drinks per occasion for women and 5 or more drinks per occasion for men. Drinking in the final week of pretreatment prior to the quit-date is not included because both groups were receiving active varenicline during this period.|First 3 weeks (pretreatment)|All participants were included in the analysis, assuming an intention to treat method.||percentage of heavy drinking days||Standard Deviation|Mean
789090|NCT00860028|Primary|Number of Participants Reporting Continuous Smoking Abstinence in the Extended Varenicline Pretreatment Versus Short-term Varenicline Pretreatment Conditions.|Compares the number of participants who reported no smoking, not even a puff, from the quit date through until the end of treatment (i.e., last 4 weeks of treatment) in the varenicline versus placebo pretreatment conditions.|Last 4 weeks of treatment|All participants were included in the analysis, assuming an intention to treat method.||Participants|||Number
789091|NCT00860067|Secondary|Number of Participants Reporting New Onset Chronic Diseases From Administration of Investigational Product Through 180 Days Post Vaccination|An NOCD was a newly diagnosed medical condition that was of a chronic, ongoing nature and was assessed by the investigator as medically significant.|Days 0-180 post vaccination|The Safety Population included participants who received any investigational product (Q=1198; All FM=600) and for whom any follow-up safety data were recorded (Q=1198; All FM=598).||participants|||Number
789092|NCT00860067|Secondary|Number of Participants Reporting Any Serious Adverse Event From Administration of Investigational Product Through 180 Days Post Vaccination|Serious adverse events were those that resulted in death; were life-threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a birth defect in the offspring of a study participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization but that, based on appropriate medical judgment, may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above.|Days 0-180 post vaccination|The Safety Population included participants who received any investigational product (Q=1198; All FM=600) and for whom any follow-up safety data were recorded (Q=1198; All FM=598).||participants|||Number
789093|NCT00860067|Secondary|Number of Participants Reporting Any Serious Adverse Event From Administration of Investigational Product Through 28 Days Post Vaccination|Serious adverse events were those that resulted in death; were life-threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a birth defect in the offspring of a study participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization but that, based on appropriate medical judgment, may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above.|Days 0-28 post vaccination|The Safety Population included participants who received any investigational product (Q=1198; All FM=600) and for whom any follow-up safety data were recorded (Q=1198; All FM=598).||participants|||Number
789094|NCT00860067|Secondary|The Number of Participants Reporting Any Adverse Event From Administration of Investigational Product Through 28 Days Post Vaccination|Any untoward medical occurrence in a patient or clinical investigation in a subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product|Days 0-28 post vaccination|The Safety Population included participants who received any investigational product (Q=1198; All FM=600) and for whom any follow-up safety data were recorded (Q=1198; All FM=598).||participants|||Number
789095|NCT00860067|Secondary|The Number of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Vaccination|Solicited symptoms were fever ≥ 100.4°F (38.0°C), runny/stuffy nose, sore throat, cough, headache, generalized muscle aches, decreased activity level (lethargy) OR tiredness/weakness, decreased appetite. Collection of specific solicited symptoms (sore throat, headache, generalized muscle aches) was omitted when, according to the judgment of the investigator, the subject was too young to reliably report a particular symptom.|Days 0-14|The Evaluable Safety Population for solicited symptoms included participants who received any investigational product (Q=1198; All FM=600) and for whom any follow-up solicited symptom safety data were recorded during the summarized period (Q=1197; All FM=597).||participants|||Number
789096|NCT00860067|Secondary|The Number of Seropositive Participants Within Each Treatment Arm Who Achieved a B/Victoria Strain-specific HAI Antibody Titer ≥ 32 Post Dose.|Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain.|Day 28-35|Participants who received a full dose of investigational product (Q=1198; FV=301), had post-dose HAI measurement (Q=1182; FV=298), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1181; FV=297), and were seropositive to the strain (Q=930; FV=231).||participants|||Number
789097|NCT00860067|Secondary|The Number of Seropositive Participants Within Each Treatment Arm Who Achieved a B/Yamagata Strain-specific HAI Antibody Titer ≥ 32 Post Dose.|Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain.|Day 28-35|Participants who received a full dose of investigational product (Q=1198; FY=299), had post-dose HAI measurement (Q=1182; FY=292), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1181; FY=292), and were seropositive to the strain (Q=983; FY=249).||participants|||Number
789098|NCT00860067|Secondary|The Number of Seropositive Participants Within Each Treatment Arm Who Achieved a A/H3N2 Strain-specific HAI Antibody Titer ≥ 32 Post Dose.|Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain.|Day 28-35|Participants who received a full dose of investigational product (Q=1198; All FM=600), had post-dose HAI measurement (Q=1182; AFM=590), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1181; All FM=589), and were seropositive to the strain (Q=373; All FM=196).||participants|||Number
789099|NCT00860067|Secondary|The Number of Seropositive Participants Within Each Treatment Arm Who Achieved a A/H1N1 Strain-specific HAI Antibody Titer ≥ 32 Post Dose.|Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain.|Day 28-35|Participants who received a full dose of investigational product (Q=1198; All FM=600), had post-dose HAI measurement (Q=1181; All FM=590) and had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1181; All FM=589), and were seropositive to the strain (Q=291; All FM=160).||participants|||Number
789100|NCT00860067|Secondary|The Number of Serosusceptible Participants Within Each Treatment Arm Who Achieved a B/Victoria Strain-specific HAI Antibody Titer ≥ 32 Post Dose.|Participants with a strain-specific baseline HAI titer ≤ 8 were considered to be serosusceptible to that strain.|Day 28-35|Participants who received a full dose of investigational product (Q=1198; FV=301), had post-dose HAI measurement (Q=1181; FV=298), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1181; FV=297), and serosusceptible (Q=250; FV=66).||participants|||Number
789101|NCT00860067|Secondary|The Number of Serosusceptible Participants Within Each Treatment Arm Who Achieved a B/Yamagata Strain-specific HAI Antibody Titer ≥ 32 Post Dose.|Participants with a strain-specific baseline HAI titer ≤ 8 were considered to be serosusceptible to that strain.|Day 28-35|Participants who received a full dose of investigational product (Q=1198, FY=299), had post-dose HAI measurement (Q=1181, FY=292), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1181; FY=292), and were serosusceptible to the strain (Q=197, FY=43).||participants|||Number
792647|NCT00887978|Post-Hoc|6-minute Walk Distance by PAH Etiology: Idiopathic PAH (IPAH) / Heritable PAH(HPAH)|Covariate analysis of change in 6MWD by PAH etiology, specifically idiopathic or heritable PAH|Baseline and 16 Weeks|Subjects with IPAH/HPAH||meters||Inter-Quartile Range|Median
789102|NCT00860067|Secondary|The Number of Serosusceptible Participants Within Each Treatment Arm Who Achieved a A/H3N2 Strain-specific HAI Antibody Titer ≥ 32 Post Dose.|Participants with a strain-specific baseline HAI titer ≤ 8 were considered to be serosusceptible to that strain.|Day 28-35|Participants who received a full dose of investigational product (Q=1198; All FM=600), had post-dose HAI measurement (Q=1181; All FM=590), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1181; All FM=589), and were serosusceptible to the strain (Q=807; All FM=393).||participants|||Number
789103|NCT00860067|Secondary|The Number of Serosusceptible Participants Within Each Treatment Arm Who Achieved a A/H1N1 Strain-specific HAI Antibody Titer ≥ 32 Post Dose.|Participants with a strain-specific baseline HAI titer ≤ 8 were considered to be serosusceptible to that strain.|Day 28-35|Participants who received a full dose of investigational product (Q=1198, All FM=600), had post-dose HAI measurement (Q=1182; All FM=590), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1181, All FM=589), and were serosusceptible to the strain(Q=889, All FM=429).||participants|||Number
789104|NCT00860067|Secondary|The Number of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Achieved a Strain-specific HAI Antibody Titer ≥ 32 Post Dose.||Day 28-35|Participants who received a full dose of investigational product (Q=1198; FY=299; FV=301; All FM=600,), had post-dose HAI measurement (Q=1182; FY=292; FV=298; All FM=290), and had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1181; FY=292; FV=298; All FM=590).||participants|||Number
789105|NCT00860067|Secondary|The Number of Seropositive Participants Within Each Treatment Arm Who Experience B/Victoria Strain-specific Seroresponse Post Dose.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain.|Day 0 and Day 28-35|Participants who received a full dose of investigational product (Q=1198, FV=301), had pre-dose and post-dose HAI measurement (Q=1181, FV=298), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1180; FV=297), and were seropositive to the strain (Q=930, FV=231).||participants|||Number
789106|NCT00860067|Secondary|The Number of Seropositive Participants Within Each Treatment Arm Who Experience B/Yamagata Strain-specific Seroresponse Post Dose.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain.|Day 0 and Day 28-35|Participants who received a full dose of investigational product (Q=1198, FY=299), had pre-dose and post-dose HAI measurement (Q=1181, FY=292), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q1180; FY=292), and were seropositive to the strain (Q=983, FY=249).||participants|||Number
789107|NCT00860067|Secondary|The Number of Seropositive Participants Within Each Treatment Arm Who Experience A/H3N2 Strain-specific Seroresponse Post Dose.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain.|Day 0 and Day 28-35|Participants who received a full dose of investigational product (Q=1198, AFM=600), had pre-dose and post-dose HAI measurement (Q=1181, AFM=590), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1180; All FM=589), and were seropositive to the strain (Q=373, All FM=196).||participants|||Number
789108|NCT00860067|Secondary|The Number of Seropositive Participants Within Each Treatment Arm Who Experience A/H1N1 Strain-specific Seroresponse Post Dose.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain.|Day 0 and Day 28-35|Participants who received a full dose of investigational product (Q=1198; All FM=600), had pre-dose and post-dose HAI measurement (Q=1181; All FM=590), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1180; All FM=589), and were seropositive to the strain (Q=291; All FM=160).||participants|||Number
789109|NCT00860067|Secondary|The Number of Serosusceptible Participants Within Each Treatment Arm Who Experience B/Victoria Strain-specific Seroresponse Post Dose.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer <= 8 were considered to be serosusceptible for that strain.|Day 0 and Day 28-35|Participants who received a full dose of investigational product (Q=1198; FV=301), had pre-dose and post-dose HAI measurement (Q=1181; FV=298), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1180; FV=297), and were serosusceptible to the strain (Q=250; FV=66).||participants|||Number
789110|NCT00860067|Secondary|The Number of Serosusceptible Participants Within Each Treatment Arm Who Experience B/Yamagata Strain-specific Seroresponse Post Dose.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer <= 8 were considered to be serosusceptible for that strain.|Day 0 and Day 28-35|Participants who received a full dose of investigational product (Q=1198; FY=299), had pre-dose and post-dose HAI measurement (Q=1181; FY=292), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1180; FY=292), and were serosusceptible to the strain (Q=197; FY=43).||participants|||Number
789111|NCT00860067|Secondary|The Number of Serosusceptible Participants Within Each Treatment Arm Who Experience A/H3N2 Strain-specific Seroresponse Post Dose.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer <= 8 were considered to be serosusceptible for that strain.|Day 0 and Day 28-35|Participants who received a full dose of investigational product (Q=1198; All FM=600), had pre-dose and post-dose HAI measurement (Q=1181; All FM=590), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1180; All FM=589), and were serosusceptible to the strain (Q=807; All FM=393).||participants|||Number
789112|NCT00860067|Secondary|The Number of Serosusceptible Participants Within Each Treatment Arm Who Experience A/H1N1 Strain-specific Seroresponse Post Dose.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer <= 8 were considered to be serosusceptible for that strain.|Day 0 and Day 28-35|Participants who received a full dose of investigational product (Q=1198; All FM=600), had pre-dose and post-dose HAI measurement (Q=1181; All FM=590), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1180; All FM=589), and were serosusceptible to the strain (Q=889; All FM=429).||participants|||Number
789113|NCT00860067|Secondary|The Number of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Experience Strain-specific Seroresponse Post Dose.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline.|Day 0 and Day 28-35|Participants who received a full dose of investigational product (Q=1198; FY=298; FV=300; All FM=598), had pre-dose and post-dose HAI measurement (Q=1181; FY=292; FV=298; All FM=599), and had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1180; FY=292; FV=297; All FM=589).||participants|||Number
789114|NCT00860067|Primary|The 4 Post-dose Strain-specific Serum Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMT) in the Q/LAIV (MEDI3250) Arm Are Noninferior to Those in the Comparator FluMist Group.|Noninferior immune response was defined as having the upper bound of the 2-sided 95% confidence intervals (CIs) for the HAI antibody GMT ratio (FluMist comparator divided by Q/LAIV) ≤ 1.5 for each of the 4 strains.|Day 28-35|Participants who received a full dose of investigational product (Q=1198; FY=299; FV=301;All FM=600), had post-dose HAI measurement (Q=1182; FY=292; FV=298; All FM=590), and had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1181; FY=292; FV=297; All FM=589).||geometric mean titer||Full Range|Geometric Mean
789115|NCT00860457|Secondary|Number of Patients With Adverse Events|Adverse events were evaluated as per the NCI Criteria for Adverse Events, version 3.0.|3 years||||||
789116|NCT00860457|Primary|Complete Response Rate|Response assessments were made per the NCI working group criteria for CLL (Hallek et al, Blood, 2008). Complete response rate is defined as an achievement of all of the following: Peripheral blood lymphocytes (evaluated by blood and differential count) below 4 × 109/L (4000/μL), absence of significant lymphadenopathy (lymph nodes must be < 1.5 cm), absence of splenomegaly and hepatomegaly, absence of constitutional symptoms, normal blood counts, and bone marrow sample must be at least normocellular for age, with less than 30% of nucleated cells being lymphocytes. Lymphoid nodules should be absent.|3 years|||percentage of patients|||Number
789117|NCT00860470|Secondary|Small for Gestation Age|Small for Gestational Age defined as birth weight <10th percentile of a standard reference (Alexander GR, Himes JH, Kaufman RB, et al. Obstet Gynecol. 1996;87(2):163-68).|December 2014|||participants|||Number
789118|NCT00860470|Secondary|Low Birth Weight|Birth weight below 2500g|December 2014|||participants|||Number
789119|NCT00860470|Secondary|Moderate to Late Preterm|Risk of birth between 32 and 37 weeks gestation|December 2014|||participants|||Number
789120|NCT00860470|Secondary|Very Pre-term|Risk of birth between 28 and 32 weeks of gestation|December 2014|||participants|||Number
789121|NCT00860470|Secondary|Extremely Pre-term|Risk of birth before 28 weeks gestation|December 2014|||participants|||Number
789122|NCT00860470|Secondary|Preterm Birth|Risk of being born before 37 weeks of gestation|December 2014|||participants|||Number
789123|NCT00860470|Secondary|Still Birth Rates|Risk of Still birth|December 2014|||participants|||Number
789124|NCT00860470|Secondary|Post-neonatal Mortality|Risk of Post-neonatal Mortality (29th -180th day of life)|Dec 2014|||participants|||Number
789125|NCT00860470|Secondary|Neonatal Mortality|Risk of neonatal Mortality (28 days of life)|Dec 2014|||participants|||Number
789126|NCT00860470|Primary|Infant Mortality Through 6 mo of Age|Risk of Infant Mortality to Age 6 months (180 days)|Dec 2014|||participants|||Number
789127|NCT00860535|Primary|Growth Factor Signature (GFS) Change From Baseline Measured by Time Weighted Average (TWA) for Days 1 to 22|"The GFS was measured by microarray analysis using the entire 101 gene signature.
The TWA is the area under the curve (AUC) divided by the time interval (for this study it was the AUC of gene-expression divided by Days 1 to 22).
Participants with blast phase Ph+ CML or Ph+ ALL were measured for change in the GFS post-treatment when treated with imatinib, dasatinib, or nilotinib, using Microarray. Change was represented as the GFS Fold Ratio of TWA for Days 1 to 22 to Baseline."|Baseline to 22 Days After Initiation of Therapy|||GFS Fold Ratio-TWA[Days1-22] to baseline||90% Confidence Interval|Mean
789128|NCT00860535|Primary|Growth Factor Signature (GFS) Variability at Baseline|"The GFS was measured by microarray analysis using the entire 101 gene signature. The GFS is quantified as the change in gene expression between two separate samples collected from the same patient. The signature has 101 genes in two oppositely regulated arms, which are pre-specified. The expression of genes in the UP arm goes up with increasing pathway activity, and the expression of genes in the DOWN arm goes down with increasing pathway activity.
The GFS variability was represented by the GFS change between two baseline samples (Mean GFS Fold Ratio [Screening to Day 1 Predose])."|Screening to Day 1 Predose|Participants whose GFS was measured using microarrays to determine the pretreatment baseline variability in participants with blast phase Ph+ CML or Ph+ ALL.||GFS Fold Ratio-Screening to Day1 Predose||90% Confidence Interval|Mean
789131|NCT00860795|Secondary|Maximal Levels of Interleukin 12 (pg/ml)|interleukin 12 was measured on days 2, 3, 7, 10 in peripheral blood mononuclear cells. The highest level on any of these days in each participant was chosen as the maximal level and used for the analysis.|10 days|Intention to treat||interleukin 12 level (pg/ml)||Standard Deviation|Mean
789132|NCT00860795|Secondary|Maximal Levels of Interleukin 6 (pg/ml)|interleukin 6 was measured on days 2, 3, 7, 10 in peripheral blood mononuclear cells. The highest level on any of these days in each participant was chosen as the maximal level and used for the analysis.|10 days|Intention to treat||interleukin 6 level (pg/ml)||Standard Deviation|Mean
789133|NCT00860795|Secondary|Maximal Levels of Interleukin 2 (pg/ml)|interleukin 2 was measured on days 2, 3, 7, 10 in peripheral blood mononuclear cells. The highest level on any of these days in each participant was chosen as the maximal level and used for the analysis.|10 days|intention to treat||interleukin 2 level (pg/ml)||Standard Deviation|Mean
789134|NCT00860795|Secondary|Adverse Effects||30 days|intention to treat||participants|Participants||Number
789135|NCT00860795|Secondary|Maximal CD25/69 Activation (% of NK CD25/69+ Cells)|NK cells with evidence of CD25/69 activation were assessed on days 2, 3, 7, and 10. The highest percentage found on one of these days in each participant was categorized as the the maximal CD25/69 activation|10 days|intention to treat||(% of NK CD25/69+ cells)||Standard Deviation|Mean
789136|NCT00860795|Secondary|Maximal Levels of Interferon Alpha (pg/ml)|interferon alpha was measured on days 2, 3, 7, 10 in peripheral blood mononuclear cells. The highest level on any of these days in each participant was chosen as the maximal level and used for the analysis.|10 days|Intention to treat||interferon alpha level (pg/ml)||Standard Deviation|Mean
789137|NCT00860795|Primary|Maximal Level of Tumor Necrosis Factor Alpha (pg/ml)|tumor necrosis factor alpha NK cells and evidence of CD25/69 activation|10 days|Intention to treat||tumor necrosis alpha level (pg/ml)||Standard Deviation|Mean
789138|NCT00860847|Secondary|1.Plasma Lipids: Total Plasma Cholesterol and Triglycerides, LDL-Cholesterol, HDL-Cholesterol, and VLDL-Cholesterol Determined by the Precipitation Method; 2. Endothelial Markers and Inflammation: C-reactive Protein and Homocysteine, as Well as GSH||1 year||||||
789139|NCT00860847|Primary|Rate of Change in Total Coronary Calcium Scores by Computed Tomography|progression of coronary artery calcium deposits as determined by computed tomography as measured by the Agatston score: The Agatston score was calculated by multiplying the lesion area (mm^2) by a density factor. The density was measured in Hounsfield units, and score of 1 for 130-199 HU, 2 for 200-299 HU, 3 for 300-399 HU, and 4 for 400 HU and greater The endpoint is the mean change (end of study value - baseline value) in each group.|1 year|all participants were analyzed||Agatston score change||Standard Deviation|Mean
789140|NCT00860951|Primary|Accuracy of Typing With BCI Keyboard.|"Accuracy for the sentence typed in each environment was calculated as the percentage of characters for which the result character matched the target character. The target characters were determined based on the next character needed to complete the sentence to be copied. In the case of errors, the next character was therefore a backspace to correct the error. The target characters were modified by subject comments to account for errors in selecting the next character.
Once sentence was typed in each environment in each session on a separate day. From the three repeated sessions, there were therefore 9 total sentences per subject with 3 measures for each environment. These were treated as repeated measures for the analysis."|mean score from 3 sessions over 29 days|||percentage accuracy||Full Range|Mean
789141|NCT00861146|Primary|Smoking Abstinence|7-day point prevalence smoking abstinence verified by breath carbon monoxide missing coded as smoking|2 weeks|||participants|||Number
789142|NCT00861146|Secondary|Proportion of Days Heavy Drinking|Heavy drinking days were defined as days with > 6 standard drinks per day for men and > 4 standard drinks per day for women. This measure examined the proportion of days heavy drinking across 28 days in follow-up weeks 9-12.|follow-up weeks 9-12|||proportion of days||Standard Deviation|Mean
789143|NCT00861146|Primary|Smoking Abstinence|7-day point prevalence smoking abstinence verified by breath carbon monoxide missing coded as smoking|12 weeks|||participants|||Number
789144|NCT00861198|Primary|Successful Procedure Completion|Defined based on the indication for SpyGlass. For cases involving biliary or pancreatic stones the procedure was considered successful when complete stone clearance was accomplished. For cases involving established or suspected nonstone-related lesions of the pancreatobiliary system, success was defined when all of the following criteria were met: successful advancement of the SpyScope to the desired target, adequate visualization of the area of interest and successful applications of all diagnostic and/or therapeutic maneuvers that were deemed necessary based on the endoscopic findings.|baseline|||participants|||Number
789145|NCT00861263|Primary|Number of Patients With Persistent or Recurrent Bleeding|The number of patients that had persistent or recurrent GI bleeding after spiral enteroscopy.|up to 6 yrs after after the endoscopy|||participants|||Number
789146|NCT00861341|Primary|Percent Platelet Aggregation Induced by Collagen|Platelet aggregation was performed by the turbidimetric method of Born with simultaneous measurement of ATP release using a Chrono-log Lumi-Aggregometer with AGGRO/LINK for Windows Software version 5.1.6. Platelet rich plasma was placed in a silicone-coated cuvette with constant stirring at 1200 rpm using a siliconized stir bar for measurement of aggregation and ATP release. Aggregation was initiated using collagen (2ug.mL). At each time point the results are shown for maximum percent aggregation with collagen for all subjects. Sample 1 was obtained at baseline (BL). Sample 2 was drawn on the same day after ingestion of a single dose of 30 mg of pioglitazone. Sample 3 was obtained 6–9 days later after the subject had ingested a single 81 mg dose of aspirin (ASA), and sample 4 was drawn later that day after ingestion of 30 mg of pioglitazone.|baseline and day 6-9|||maximum percentage aggregation||Standard Deviation|Mean
789147|NCT00861341|Primary|Percent Platelet Aggregation Induced by Arachidonic Acid|Platelet aggregation was performed by the turbidimetric method of Born with simultaneous measurement of ATP release using a Chrono-log Lumi-Aggregometer with AGGRO/LINK for Windows Software version 5.1.6. Platelet rich plasma was placed in a silicone-coated cuvette with constant stirring at 1200 rpm using a siliconized stir bar for measurement of aggregation and ATP release. Aggregation was initiated using arachidonic acid (0.5 mM). At each time point the results are shown for maximum percent aggregation with arachidonic acid for all subjects. Sample 1 was obtained at baseline (BL). Sample 2 was drawn on the same day after ingestion of a single dose of 30 mg of pioglitazone. Sample 3 was obtained 6–9 days later after the subject had ingested a single 81 mg dose of aspirin (ASA), and sample 4 was drawn later that day after ingestion of 30 mg of pioglitazone.|at baseline and days 6-9|Analysis population determined per protocol.||maximum percentage aggregation||Standard Deviation|Mean
792664|NCT00888355|Other Pre-specified|Number of Patients Discontinued Due to LAEs|Patients discontinued due to LAEs during the 12-week treatment period|12 weeks|All patients who took study medication and had any laboratory tests performed were included in the analysis||Participants|||Number
789150|NCT00861471|Secondary|Percentage of Participants With Measurable Disease Response|Measurable disease response is defined as the number of participants whose best response is complete response or partial response over the number of patients with measurable desease according to the Response Evaluation Criteria in Solid Tumors (RECIST).|up to 2 years|Based on the participants with measurable disease||percentage of participants|||Number
789151|NCT00861471|Secondary|Percentage of Participants With Greater or Equal to 80% PSA Reduction From Baseline Without Clinical or Radiologic Evidence of Progression|PSA was measured at baseline on day 1/cycle 1 before treatment, then day 1 of every cycle afterwards during therapy.|up to 9 months|The analysis was based on intent-to-treat population||percentage of participants|||Number
789152|NCT00861471|Primary|Percentage of Participants With Prostate Specific Antigen (PSA) Response|PSA response is defined as a greater than or equal to a 50% decrease in PSA from the baseline without clinical or radiologic evidence of progression according to the Response Evaluation Criteria in Solid Tumors (RECIST). PSA concentration was measured at baseline on day 1/cycle 1 before treatment, then day 1 of every cycle afterwards during therapy.|up to 9 months|The analysis was based on intent-to-treat population.||percentage of participants|||Number
789153|NCT00861601|Secondary|Log-transformed AUC(0-t) and AUC(0-24) on Days 14 and 15 in Participants Receiving Eltrombopag 12.5 mg|Serial PK samples were collected over a 24-hour (h) period on Days 14 and 15 in participants receiving eltrombopag 12.5 mg. A total of 8 blood samples (3 milliliters per sample) were collected at pre-dose, and at 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, and 24 h post-dose. AUC(0-t)=area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration, and AUC(0-24)=area under the concentration-time curve from 0 (pre-dose) to 24 hours.|Day 14, Day 15|PK Parameter Population||hours * ng/ml||95% Confidence Interval|Geometric Mean
789154|NCT00861601|Secondary|Log-transformed Tmax on Days 14 and 15 in Participants Receiving Eltrombopag 12.5 mg|Serial PK samples were collected over a 24-hour (h) period on Days 14 and 15 in participants receiving eltrombopag 12.5 mg. A total of 8 blood samples (3 milliliters per sample) were collected at pre-dose, and at 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, and 24 h post-dose. Tmax=maximum drug concentration time.|Day 14, Day 15|PK Parameter Population||hours||95% Confidence Interval|Geometric Mean
789155|NCT00861601|Secondary|Log-transformed Cmax on Days 14 and 15 in Participants Receiving Eltrombopag 12.5 mg|Serial PK samples were collected over a 24-hour (h) period on Days 14 and 15 in participants receiving eltrombopag 12.5 mg. A total of 8 blood samples (3 milliliters per sample) were collected at pre-dose, and at 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, and 24 h post-dose. Cmax=maximum drug concentration.|Day 14, Day 15|PK Parameter Population: all participants from whom a PK sample was obtained and analyzed and whose PK parameter data was evaluated. One of the 12 participants took a prohibited medication that might have decreased the absorption of eltrombopag during the treatment period and was hence excluded from the PK Parameter Population.||nanograms/milliliter (ng/ml)||95% Confidence Interval|Geometric Mean
789156|NCT00861601|Secondary|Change From Baseline in Platelet Counts on Day 15 by Age|"Change from Baseline was calculated as the Day 15 value minus the Baseline value. The numbers of participants in each age category are illustrated by the n's in the category titles."|Baseline, Day 15|FAS||10^9/Liter||Standard Deviation|Mean
789157|NCT00861601|Secondary|Change From Baseline in Platelet Counts on Day 15 by Sex|"Change from Baseline was calculated as the Day 15 value minus the Baseline value. The numbers of females and males in each treatment group are illustrated by the n's in the category titles."|Baseline, Day 15|FAS||10^9/Liter||Standard Deviation|Mean
789158|NCT00861601|Secondary|Change From Baseline in Platelet Counts on Day 15 by Child-Pugh Class|Change from Baseline was calculated as the Day 15 value minus the Baseline value. The Child-Pugh (CP) score (ranging from 5 to 15, with 5 being mild and 15 being severe), calculated based on total bilirubin, serum albumin, international normalized ratio, ascites, and hepatic encephalopathy, is used to assess the severity of liver disease. A CP score of 5 or 6 is classified as Class A (mild), a score of 7-9 is classified as Class B (moderate), and a score >=10 is classified as Class C (severe). Participants with a CP score <10 were enrolled in the study.|Baseline, Day 15|FAS. The number of participants categorized as Class A or Class B is given in the category titles.||10^9/Liter||Standard Deviation|Mean
789159|NCT00861601|Secondary|Percentage of Responders on Day 22|A responder was defined as a participant with a platelet count within the target range (>=80 x 10^9/Liter) on Day 22 after receiving eltrombopag for an additional week from Day 15, on which his or her platelet count was <80 x 10^9/Liter.|Day 22|FAS. Participants in the 12.5 mg group have no data on Day 22 because they received the medication for only 14 days. Only 6 participants in the 25 mg group and 2 participants in the 37.5 mg group received the medication for an additional week, because they had a platelet count <80 x 10^9/Liter on Day 15.||percentage of responders||95% Confidence Interval|Mean
789160|NCT00861601|Secondary|Percentage of Responders on Day 15|A responder was defined as a participant with a platelet count within the target range (>=80 x 10^9/Liter) on Day 15.|Day 15|FAS||percentage of responders||95% Confidence Interval|Mean
789161|NCT00861601|Secondary|Change From Baseline in Platelet Counts by Post-Treatment Visit|Platelet counts were measured by blood draw. Change from Baseline was calculated as the value at each visit minus the Baseline value.|4 days post-treatment, 8 days post-treatment, and 15 days post-treatment|FAS. The number of participants analyzed varies by visit, because the platelet count data on 4 days post-treatment in one participant in the 37.5 mg group is missing and the platelet count data post-specific therapies affecting the evaluation of efficacy are excluded from this efficacy analysis.||10^9/Liter||Standard Deviation|Mean
789162|NCT00861601|Secondary|Change From Baseline in Platelet Counts by Treatment Visit|Platelet counts were measured by blood draw. The Final Assessment Point is the last visit during the treatment period, which is Day 15 or Day 22. Change from Baseline was calculated as the value at each visit minus the Baseline value.|Baseline, Day 8, Day 15, and Final Assessment Point (Day 15 or Day 22)|FAS. The number of participants analyzed varies by visit, because the platelet count data on 4 days post-treatment in one participant in the 37.5 mg group is missing and the platelet count data post-specific therapies affecting the evaluation of efficacy are excluded from this efficacy analysis.||10^9/Liter||Standard Deviation|Mean
789249|NCT00861757|Secondary|Change From Baseline in Prostate Specific Antigen (PSA) at 12 Weeks|Nanograms of PSA per milliliter (ng/mL) of blood.|baseline, 12 weeks|The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis.||microgram/Liter||Standard Deviation|Mean
789163|NCT00861601|Secondary|Platelet Counts at Day 22|Platelet counts were measured by blood draw. The Final Assessment Point is the last visit during the treatment period, which is Day 15 or Day 22.|Day 22|FAS. Participants in the 12.5 mg group have no data on Day 22 because they received the medication for only 14 days. Only 6 participants in the 25 mg group and 2 participants in the 37.5 mg group received the medication for an additional week, because they had a platelet count <80 x 10^9/Liter on Day 15.||10^9/Liter||Full Range|Median
789164|NCT00861601|Secondary|Platelet Counts by Post-Treatment Visit|Platelet counts were measured by blood draw.|4 days post-treatment, 8 days post-treatment, and 15 days post-treatment|FAS. The number of participants analyzed varies by visit, because the platelet count data on 4 days post-treatment in one participant in the 37.5 mg group are missing and the platelet count data post-specific therapies affecting the evaluation of efficacy are excluded from this efficacy analysis.||10^9/Liter||Full Range|Median
789165|NCT00861601|Secondary|Platelet Counts by Treatment Visit|Platelet counts were measured by blood draw. The Final Assessment Point is the last visit during the treatment period, which is Day 15 or Day 22.|Day 1 (Baseline), Day 8, Day 15, and Final Assessment Point (Day 15 or Day 22)|FAS. The number of participants analyzed varies by visit, because the platelet count data on 4 days post-treatment in one participant in the 37.5 mg group are missing and the platelet count data post-specific therapies affecting the evaluation of efficacy are excluded from this efficacy analysis.||10^9/Liter||Full Range|Median
789166|NCT00861601|Secondary|Percent Change From Baseline in Platelet Counts on Day 15|Platelet counts were measured by blood draw. Change from Baseline was calculated as the Day 15 value minus the Baseline value.|Baseline, Day 15|FAS||Percent change||95% Confidence Interval|Mean
789167|NCT00861601|Secondary|Analysis of Covariance for Three Patterns of Dose Response Using the Change From Baseline in Platelet Counts (Baseline of Platelet Counts and Child-Pugh Class as Covariates)|Exploratory analysis was conducted to see a dose response/trend when a dose goes high with the changes from baseline in platelet counts (12.5 mg, 25 mg, and 37.5 mg) on Day 15 of each subject. The data were analyzed with baseline of platelet counts and Child-Pugh class as covariate for the following dose response pattern using contrast: (1) linearity, (2) saturation at the medium dose, (3) onset of response at the high dose.|Baseline, Day 15|FAS||10^9/Liter||95% Confidence Interval|Mean
789168|NCT00861601|Secondary|Analysis of Covariance for Three Patterns of Dose Response Using the Change From Baseline in Platelet Counts (Baseline Platelet Counts as Covariate)|Exploratory analysis was conducted to see a dose response/trend when a dose goes high with the changes from baseline in platelet counts (12.5 mg, 25 mg, and 37.5 mg) on Day 15 of each subject. The data were analyzed with baseline of platelet counts as covariate for the following dose response pattern using contrast: (1) linearity, (2) saturation at the medium dose, (3) onset of response at the high dose.|Baseline, Day 15|FAS||10^9/Liter||95% Confidence Interval|Mean
789169|NCT00861601|Primary|Change From Baseline in Platelet Counts on Day 15|Platelet counts were measured by blood draw. Change from Baseline was calculated as the Day 15 value minus the Baseline value.|Baseline, Day 15|Full Analysis Set (FAS): all enrolled participants, excluding those who received no doses of eltrombopag during the treatment period, those without a baseline platelet assessment, and those without at least one on-therapy (scheduled or unscheduled) platelet assessment.||10^9/Liter||95% Confidence Interval|Mean
789170|NCT00861614|Secondary|Number of Participants With Worst On-Study Renal Function Common Toxicity Criteria (CTC) Grade and Shift From Baseline|Comparison of baseline versus worst grade renal function as measured by creatinine analysis. National Cancer Institute Common Terminology Criteria (CTC) version (v) 3.0 was used to determine Grade (Gr).Gr 0: within normal range. Abnormal values for Creatinine were based on Gr 1: > 1.0 - 1.5*ULN; Gr 2: > 1.5 - 3.0*ULN; Gr 3: > 3.0 - 6.0*ULN; Gr 4: > 6.0*ULN.|Day 1 to 70 days after last dose of study drug|All treated participants||participants|||Number
789171|NCT00861614|Secondary|Number of Participants With Worst On-Study Serum Chemistry Common Toxicity Criteria (CTC) Grade and Shift From Baseline|Comparison of baseline versus worst grade serum chemistry as measured by lipase and amylase analysis. National Cancer Institute Common Terminology Criteria (CTC) version (v) 3.0 was used to determine Grade (Gr). Gr 0: within normal range. Abnormal values for lipase: Gr1: > 1.0 - 1.5 * ULN; Gr2: > 1.5 - 2.0 * ULN; Gr 3: > 2.0 - 5.0 * ULN; Gr4: > 5.0*ULN. Abnormal values for amylase: Gr1: > 1.0 - 1.5 * ULN; Gr 2: > 1.5 - 2.0 * ULN; Gr 3: > 2.0 - 5.0 * ULN; Gr4: > 5.0 * ULN.|Day 1 to 70 days after last dose of study drug|All treated participants||participants|||Number
789172|NCT00861614|Secondary|Number of Participants With Worst On-Study Liver Common Toxicity Criteria (CTC) Grade and Shift From Baseline|Comparison of baseline versus worst grade liver function as measured by alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin and alkaline phosphatase (ALP). National Cancer Institute Common Terminology Criteria (CTC) version (v) 3.0 was used to determine Grade (Gr). Gr 0: within normal range. Abnormal values for ALP, ALT and AST were based on grades; Gr 1: > 1.0 - 2.5 * upper limits of normal (ULN); Gr 2: > 2.5 - 5.0 * ULN; Gr 3: > 5.0 - 20.0 * ULN; Gr 4: > 20.0 * ULN. Abnormal values for Total Bilirubin were based on Gr 1: > 1.0 - 1.5 * upper limits of normal (ULN); Gr 2: > 1.5 - 3.0 * ULN; Gr 3: > 3.0 - 10.0 * ULN; Gr 4: > 10.0 * ULN.|Day 1 to 70 days after last dose of study drug|All treated participants||participants|||Number
789173|NCT00861614|Secondary|Number of Participants With Worst On-Study Hematology Common Toxicity Criteria (CTC) Grade and Shift From Baseline|Comparison of baseline versus worst grade hematology laboratory tests as measured by white blood count (WBC), absolute neutrophil count (ANC), platelet count, hemoglobin and lymphocyte results. National Cancer Institute Common Terminology Criteria (CTC) version (v) 3.0 was used to determine Grade (Gr). Gr 0: within normal range. Abnormal values for WBC were based on Gr 1: 3.0 - < Lower Limit of Normal (LLN); Gr 2: 2.0 - < 3.0; Gr 3: 1.0 - < 2.0; Gr4: < 1.0. Abnormal values for Hemoglobin were based on Gr 1: 10.0 - < LLN; Gr 2: 8.0 - < 10.0; Gr 3: 6.5 - < 8.0; Gr 4: < 6.5. Abnormal values for Lymphocytes were based on Gr 1: 0.8 - < 1.5; Gr 2: 0.5 - < 0.8; Gr 3): 0.2 - < 0.5; Gr 4: < 0.2. Abnormal values for ANC were based on Gr 1: 1.5 - < 2.0; Gr 2: 1.0 - < 1.5; Gr 3: 0.5 - < 1.0; Gr 4: < 0.5. Abnormal values for Platelets were based on Gr 1: 75.0 - < LLN; Gr 2: 50.0 - < 75.0; Gr 3: 25.0 - < 50.0; Gr 4: < 25.0.|Day 1 to 70 days after last dose of study drug|All treated participants||participants|||Number
789234|NCT00861744|Secondary|Number of Subjects With Anti-hepatitis A Antibody Concentrations Equal to or Above the Cut-off-value.|Anti-hepatitis A antibody cut-off-value assessed was ≥15 milli-International Units per milliliter (mIU/mL).|At Day 42 after administration of a dose of Havrix vaccine.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.||Subjects|||Number
789174|NCT00861614|Secondary|Time to Resolution of Grade 3 to 5 to Grade 0 Immune-Mediated Adverse Reactions (imARs) to Grade 0|"Time between the date of onset of an imAR to the date of resolution date of the event or the last known date participant was alive if an event did not resolve.
Only the Ipilimumab + Radiotherapy group of participants was included in the analysis because ipilimumab is associated with inflammatory events resulting from increased or excessive immune activity likely to be related to its mechanism of action."|Day 1 to 70 days after last dose of study drug|All treated participants receiving Ipilimumab + Radiotherapy||weeks||Full Range|Median
789175|NCT00861614|Secondary|Time to Onset of Grade 3 to 5 Immune-Mediated Adverse Reaction (imAR)|"The time between first dose of study drug and date of earliest Grade 3 or 4 imAR. ImARs were collected prospectively and grouped into enterocolitis, hepatitis, dermatitis, neuropathies and endocrinopathies and graded using Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE), Ver. 3.0.
Only the Ipilimumab + Radiotherapy group of participants was included in the analysis because ipilimumab is associated with inflammatory events resulting from increased or excessive immune activity likely to be related to its mechanism of action."|Day 1 to time of onset of the imAR of interest|All treated participants receiving Ipilimumab + Radiotherapy||weeks||Full Range|Median
789176|NCT00861614|Secondary|Time to Resolution of Grade 3 or 4 Immune-Related Adverse Event (irAE)|Time between the date of onset of a Grade 3 or 4 irAE and the date of improvement to Grade 1 or less or the worst grade at baseline.|Day 1 to 70 days after last dose of study drug|All treated participants||weeks||95% Confidence Interval|Median
789177|NCT00861614|Secondary|Time to Onset of Grade 3 or 4 Immune-Related Adverse Event (irAE)|The time between first dose of study drug and date of earliest Grade 3 or 4 irAE. These irAEs are AEs of unknown etiology, consistent with an immune phenomenon and considered as causally related to drug exposure. The five subcategories of irAE examined include gastrointestinal (GI), liver, skin, endocrine, and neurological and are graded using the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.|Day 1 to 70 days after last dose of study drug|All treated participants||weeks||95% Confidence Interval|Median
789178|NCT00861614|Secondary|Number of Participants With Severe Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs, Immune-Related Adverse Events (irAE) and Immune-Mediated Adverse Reaction (imAR)|"AE=any new unfavorable symptom, sign or disease or worsening of a preexisting condition that may not have a causal relationship with treatment.
SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity or drug dependency/abuse; is life-threatening, an important medical event or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible or missing relationship to study drug. Death=during study and up to 70 days after last dose. IrAEs=AEs potentially associated with inflammation and considered to be causally related to study drug and grouped into gastrointestinal (GI), hepatic, skin, endocrine and neurological. ImARs were collected prospectively and grouped into enterocolitis, hepatitis, dermatitis, neuropathies and endocrinopathies. IrAEs/ imARs were graded using Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE), Ver. 3.0."|Randomization to date of death|All treated participants||participants|||Number
789179|NCT00861614|Secondary|Duration of Pain Response|The time between the initial date of pain response and completion date of pain response. The initial date when the pain response criterion was achieved was considered the pain response date. The earlier of date of death, date of tumor resection surgery, or date when pain response criterion was no longer met was considered the completion date of the pain response. If none of these scenarios occurred, the completion of the pain response was set to the last known alive date.|Day of initial pain response to day of completion of pain response or date of death|All pain-evaluable participants with pain response||months||95% Confidence Interval|Median
789180|NCT00861614|Secondary|Pain Response|The percentage of participants with a pain response assessed using the Brief Pain Inventory Short Form (BPI-SF) completed by participants throughout the study in a daily diary log. Pain-evaluable participants were defined as those with a decrease in the average daily worst pain intensity by at least 30% from baseline, maintained over 2 consecutive evaluations without the use of any rescue analgesic medication or increase in analgesic use in the same time period.|Assessed at screening, weeks 12, 18, 24, and at the end of treatment visit|All pain-evaluable participants||percentage of participants||95% Confidence Interval|Number
789181|NCT00861614|Secondary|Progression Free Survival (PFS)|All PFS events were based on investigator’s assessment. Participants who were alive and did not experience a PFS event were censored at the earlier of the latest prostate-specific antigen (PSA) or radiological tumor assessment date. Participants who did not die, showed no clinical deterioration, and who had no recorded post-baseline PSA or radiological tumor assessment were censored at randomization date.|Date of randomization to earliest date of confirmed PSA or radiological progression, clinical deterioration or death|All randomized participants||months||95% Confidence Interval|Median
789182|NCT00861614|Primary|Overall Survival Rate|The overall survival (OS) rate is a percentage, representing the fraction of all randomized participants who were alive following treatment, from 1 to 5 years. OS was defined as the time between the date of randomization and the date of death as a result of any cause. Survival rates were determined via Kaplan-Meier estimates.|Date of randomization to date of death|All randomized participants||percentage of participants||95% Confidence Interval|Number
789183|NCT00861614|Primary|Overall Survival (OS)|OS is defined as the time in months from randomization date to date of death due to any cause in all randomized subjects. For participants alive at the time of the database cutoff date, OS was censored at the last date the participant was known to be alive.|Date of randomization to date of death|All randomized participants||months||95% Confidence Interval|Median
789184|NCT00861692|Primary|Number of Patients With Platelet Count Recovery|Platelet increase of ≥ 100G/L or 50%.|Day 3|Data are missing in 3 patients.||participants|||Number
789185|NCT00861692|Primary|Number of Patients With Major or Minor Bleeding|"Major bleeding is defined as i) overt and associated with a fall in the haemoglobin level 2 g/dl or more, ii) leads to transfusion of 2 units or more, iii) is retroperitoneal, iv) occurs into a major prosthetic joint, or v) in intracranial.
Minor bleeding is defined as overt bleeding that does not meet the criteria of major bleeding."|During and 30 days after argatroban treatment|||participants|||Number
789186|NCT00861692|Primary|Number of Patients With Unplanned Amputation||During and 30 days after argatroban treatment|||participants|||Number
789193|NCT00861705|Primary|Pathologic Complete Response (pCR) in the Breast. Defined as the Absence of Residual Invasive Carcinoma in the Breast (ypT0/is).|Assessment of the difference in percentage of participants with pCR in the breast between regimens that contain bevacizumab (arms 2&4) versus not (arms 1&3) will use a one-sided chi square test. 95% confidence intervals around the incidence of pCR will also be constructed using exact binomial methods.|At the time of definitive surgical removal, up to 28 weeks|All patients who began protocol neoadjuvant therapy and are assessable for pCR endpoint (N=433).||percentage of participants with pCR||95% Confidence Interval|Number
789194|NCT00861705|Secondary|Recurrence-free Survival|From definitive surgery to first instance of ipsilateral invasive breast tumor recurrence, local/regional invasive breast cancer recurrence, distant recurrence, or death from any cause.|up to 10 years||10/2018||||
789195|NCT00861705|Secondary|Overall Survival|From study entry to death due to any cause|up to 10 years||10/2018||||
789196|NCT00861705|Secondary|Clinical Response Assessed by Tumor Measurement|Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)|Baseline; at completion of neoadjuvant therapy||10/2018||||
789197|NCT00861705|Secondary|Radiographic Response Assessed by Tumor Measurement|Assessed by RECIST|Baseline; at completion of neoadjuvant therapy||10/2018||||
789198|NCT00861705|Secondary|Pathologic Stage in the Breast and in the Breast Plus Axilla as Measured by American Joint Committee on Cancer (AJCC) Tumor Node Metastasis (TNM) Staging Criteria (Version 6)||at definitive surgery, up to 28 weeks||10/2018||||
789199|NCT00861705|Secondary|Pathologic Complete Response (pCR) in the Breast and Axilla. Defined as the Absence of Residual Invasive Carcinoma in the Breast (ypT0/is) Plus the Absence of Any Tumor Deposit >0.2 mm in Sampled Axillary Nodes (ypT0/isN0).|Comparing regimens that contain bevacizumab (arms 2&4) versus not (arms 1&3).|At the time of definitive surgical removal, up to 28 weeks|||percentage of participants with pCR||95% Confidence Interval|Number
789200|NCT00861705|Secondary|Pathologic Complete Response (pCR) in the Breast and Axilla. Defined as the Absence of Residual Invasive Carcinoma in the Breast (ypT0/is) Plus the Absence of Any Tumor Deposit >0.2 mm in Sampled Axillary Nodes (ypT0/isN0).|Comparing regimens that contain carboplatin (arms 3&4) versus not (arms 1&2).|At the time of definitive surgical removal, up to 28 weeks|||percentage of participants with pCR||95% Confidence Interval|Number
789201|NCT00861705|Primary|Pathologic Complete Response (pCR) in the Breast. Defined as the Absence of Residual Invasive Carcinoma in the Breast (ypT0/is).|Assessment of the difference in percentage of participants with pCR in the breast between regimens that contain carboplatin (arms 3&4) versus not (arms 1&2) will use a one-sided chi square test. 95% confidence intervals around the incidence of pCR will also be constructed using exact binomial methods.|At the time of definitive surgical removal, up to 28 weeks|All patients who began protocol neoadjuvant therapy and are assessable for pCR endpoint (N=433).||percentage of participants with pCR||95% Confidence Interval|Number
789202|NCT00861744|Secondary|Number of Subjects With Anti-mumps Virus Antibody Concentrations Above the Cut-off Value (PPD ELISA)|Anti-mumps virus antibody cut-off-value assessed was ≥ 10 ELISA units per milliliter (EU/mL)|At 2 years post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 2, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 2 post-vaccination and who complied with blood sampling schedules.||Subjects|||Number
789203|NCT00861744|Secondary|Anti-mumps Virus Antibody Concentrations (PPD ELISA)|Antibody concentrations are expressed as Geometric Mean Concentrations (GMC) in ELISA units per milliliter (EU/mL). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <5 EU/mL prior to vaccination.|At 2 years post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 2, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 2 post-vaccination and who complied with blood sampling schedules.||EU/mL||95% Confidence Interval|Geometric Mean
789204|NCT00861744|Secondary|Number of Subjects With Anti-mumps Virus Antibody Concentrations Above the Cut-off Value (PPD ELISA)|Anti-mumps virus antibody cut-off-value assessed was ≥ 10 ELISA units per milliliter (EU/mL)|At 1 year post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules.||Subjects|||Number
789205|NCT00861744|Secondary|Anti-mumps Virus Antibody Concentrations (Pharmaceutical Product Development (PPD) ELISA)|Antibody concentrations are expressed as Geometric Mean Concentrations (GMC) in ELISA units per milliliter (EU/mL). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <5 EU/mL prior to vaccination.|At 1 year post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules.||EU/mL||95% Confidence Interval|Geometric Mean
789206|NCT00861744|Secondary|Number of Subjects With Anti-mumps Virus Antibody Titers Above the Cut-off Value (Unenhanced PRN)|Anti-mumps virus antibody cut-off-value assessed was ≥ 4 Estimated Dose 50 (ED50).|At 2 years post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 2, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 2 post-vaccination and who complied with blood sampling schedules.||Subjects|||Number
789207|NCT00861744|Secondary|Anti-mumps Virus Antibody Titers (Unenhanced PRN)|Antibody concentrations are expressed as Geometric Mean Titer (GMT).|At 2 years post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 2, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 2 post-vaccination and who complied with blood sampling schedules.||Titer||95% Confidence Interval|Geometric Mean
792665|NCT00888355|Other Pre-specified|Number of Patients With Drug-related LAEs|Patients with drug-related LAEs during the 12-week treatment period|12 weeks|All patients who took study medication and had any laboratory tests performed were included in the analysis.||Participants|||Number
789208|NCT00861744|Secondary|Number of Subjects With Anti-mumps Virus Antibody Titers Above the Cut-off Value (Unenhanced PRN)|Anti-mumps virus antibody cut-off-value assessed was ≥ 4 Estimated Dose 50 (ED50).|At 1 year post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules.||Subjects|||Number
789209|NCT00861744|Secondary|Anti-mumps Virus Antibody Titers (Unenhanced PRN)|Antibody titers were expressed as Geometric Mean Titer (GMT).|At 1 year post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules.||Titer||95% Confidence Interval|Geometric Mean
789210|NCT00861744|Secondary|Number of Subjects Reporting Conditions Prompting Emergency Room (ER) Visits.||From Day 0 to Day 180 after vaccination|The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.||Subjects|||Number
789211|NCT00861744|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are congenital anomaly/birth defect in the offspring of a study subject.|From Day 180 to Day 730 after vaccination|The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.||Subjects|||Number
789212|NCT00861744|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Day 0 to Day 180 after vaccination|The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.||Subjects|||Number
789213|NCT00861744|Secondary|Number of Subjects Reporting New Onset Chronic Illnesses (NOCIs).|NOCIs included autoimmune disorders, asthma, type I diabetes, allergies.|From Day 0 to Day 180 after vaccination|The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.||Subjects|||Number
789214|NCT00861744|Secondary|Number of Subjects With Solicited General Symptoms.|Assessed solicited general symptoms were drowsiness, irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade.|During the 15-day (Days 0-14) post-vaccination period|The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and symptom sheet completed, only on subjects that reported the specific symptom.||Subjects|||Number
789215|NCT00861744|Secondary|Number of Subjects Reporting Investigator-confirmed Parotid/Salivary Gland Swelling.|Swelling with accompanying general symptoms|During the 43-day (Days 0-42) post-vaccination period|The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and symptom sheet completed, only on subjects that reported the specific symptom.||Subjects|||Number
789216|NCT00861744|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs).|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 43-day (Days 0-42) post-vaccination period|The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.||Subjects|||Number
789217|NCT00861744|Secondary|Number of Subjects Reporting Medically Attended Visit (MAEs)|MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.|During the 43-day (Days 0-42) post-vaccination period|The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.||Subjects|||Number
789218|NCT00861744|Secondary|Number of Subjects With Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling.|During the 4-day (Days 0-3) post-vaccination period|The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and symptom sheet completed, only on subjects that reported the specific symptom.||Subjects|||Number
789219|NCT00861744|Secondary|Number of Subjects Reporting Fever.|fever is assessed for temperature ≥38°C/100.4°F and >39.5°C/103.1°F as measured rectally.|During the 15-day (Days 0-14) and 43 days (Days 0-42) post-vaccination period|The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and symptom sheet completed, only on subjects that reported the specific symptom.||Subjects|||Number
789220|NCT00861744|Secondary|Anti-rubella Virus Antibody Concentrations|Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in IU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <4 IU/mL prior to vaccination.|At 2 years post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 2, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 2 post-vaccination and who complied with blood sampling schedules.||IU/mL||95% Confidence Interval|Geometric Mean
789232|NCT00861744|Secondary|Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value|Anti-measles virus antibody cut-off-value assessed was ≥ 200 milli-International Units per milliliter (mIU/mL).|At 1 year post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules.||Subjects|||Number
789221|NCT00861744|Secondary|Anti-rubella Virus Antibody Concentrations|Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in IU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <4 IU/mL prior to vaccination.|At 1 year post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules.||IU/mL||95% Confidence Interval|Geometric Mean
789222|NCT00861744|Secondary|Number of Subjects With Anti-rubella Virus Antibody Concentrations Equal to or Above the Cut-off-value.|Anti-rubella virus antibody cut-off-value assessed was ≥ 10 International Units per milliliter (IU/mL).|At 2 years post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 2, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 2 post-vaccination and who complied with blood sampling schedules.||Subjects|||Number
789223|NCT00861744|Secondary|Number of Subjects With Anti-rubella Virus Antibody Concentrations Equal to or Above the Cut-off-value.|Anti-rubella virus antibody cut-off-value assessed was ≥ 10 International Units per milliliter (IU/mL). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <4 IU/mL prior to vaccination.|At 1 year post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules.||Subjects|||Number
789224|NCT00861744|Secondary|Number of Subjects With Anti-mumps Virus Antibody Titers Above the Cut-off Value (Enhanced PRN)|Anti-mumps virus antibody cut-off-value assessed was ≥ 51 ED50.|At 1 year post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules.||Subjects|||Number
789225|NCT00861744|Secondary|Number of Subjects Reporting Other Rash.|Other rash = not confirmed by the investigator to be either measles/rubella-like or varicella-like in nature|During the 43-day (Days 0-42) post-vaccination period|The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and symptom sheet completed, only on subjects that reported the specific symptom.||Subjects|||Number
789226|NCT00861744|Secondary|Number of Subjects Reporting Febrile Convulsions|Timing of febrile convulsions: events occured on Day 29 in the Priorix 2 Group and Day 0 in the MMR II Group. All cases of febrile convulsions were case of meningism.|During the 43-day (Days 0-42) post-vaccination period|The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and symptom sheet completed, only on subjects that reported the specific symptom.||Subjects|||Number
789227|NCT00861744|Secondary|Anti-mumps Virus Antibody Titers (Enhanced Plaque Reduction Neutralization (PRN))|Antibody titers were expressed as Geometric Mean Titer (GMT). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with antibody titer < 24 ED50 prior to vaccination.|At 1 year post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules.||Titers||95% Confidence Interval|Geometric Mean
789228|NCT00861744|Secondary|Number of Subjects Reporting Investigator-confirmed Measles/Rubella-like Rash and Varicella-like Rash.||During the 43-day (Days 0-42) post-vaccination period|The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and symptom sheet completed, only on subjects that reported the specific symptom.||Subjects|||Number
789229|NCT00861744|Secondary|Anti-measles Virus Antibody Concentrations|Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations <150 mIU/mL prior to vaccination.|At 1 year post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules.||mIU/mL||95% Confidence Interval|Geometric Mean
789230|NCT00861744|Secondary|Anti-measles Virus Antibody Concentrations|Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations <150 mIU/mL prior to vaccination.|At 2 years post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 2, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 2 post-vaccination and who complied with blood sampling schedules.||mIU/mL||95% Confidence Interval|Geometric Mean
789231|NCT00861744|Secondary|Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value|Anti-measles virus antibody cut-off-value assessed was ≥ 200 milli-International Units per milliliter (mIU/mL).|At 2 years post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 2, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 2 post-vaccination and who complied with blood sampling schedules.||Subjects|||Number
789233|NCT00861744|Secondary|Anti-S. Pneumoniae Antibody Concentrations (by Serotype).|Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in µg/mL.|At Day 0 before vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.||µg/mL||95% Confidence Interval|Geometric Mean
789235|NCT00861744|Secondary|Anti-hepatitis A Virus Antibody Concentrations.|Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-hepatitis A virus antibody concentrations <15 mIU/mL prior to vaccination.|At Day 42 after administration of a dose of Havrix vaccine.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.||mIU/mL||95% Confidence Interval|Geometric Mean
789236|NCT00861744|Secondary|Anti-varicella Antibody Concentrations.|Antibody concentrations are expressed as Geometric Mean Titers (GMT). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with antibody concentration < 25 mIU/mL prior to vaccination.|At Day 42 after administration of a dose of Varivax vaccine.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.||mIU/mL||95% Confidence Interval|Geometric Mean
789237|NCT00861744|Secondary|Anti-S. Pneumoniae Antibody Concentrations (by Serotype).|Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in µg/mL.|At Day 42 after vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.||µg/mL||95% Confidence Interval|Geometric Mean
789238|NCT00861744|Secondary|Anti-rubella Virus Antibody Concentrations|Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in IU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <4 IU/mL prior to vaccination.|At Day 42 after administration of a dose of Priorix vaccine.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.||IU/mL||95% Confidence Interval|Geometric Mean
789239|NCT00861744|Secondary|Anti-mumps Virus Antibody Concentrations|Antibody concentrations are expressed as Geometric Mean Titer (GMT). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with antibody titer < 24 ED50 prior to vaccination.|At Day 42 after administration of a dose of Priorix vaccine.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.||Titers||95% Confidence Interval|Geometric Mean
789240|NCT00861744|Secondary|Anti-measles Virus Antibody Concentrations|Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations <150 mIU/mL prior to vaccination.|At Day 42 after administration of a dose of Priorix vaccine.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.||mIU/mL||95% Confidence Interval|Geometric Mean
789241|NCT00861744|Secondary|Number of Subjects With Anti-varicella Antibody Concentration Equal to or Above the Cut-off-value.|Anti-varicella virus antibody cut-off-value assessed was ≥ 75 milli-International Units per milliliter (mIU/mL).|At Day 42 after administration of a dose of Varivax vaccine.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.||Subjects|||Number
789242|NCT00861744|Primary|Number of Subjects With Anti-rubella Virus Antibody Concentrations Equal to or Above the Cut-off-value.|Anti-rubella virus antibody cut-off-value assessed was ≥ 10 International Units per milliliter (IU/mL).|At Day 42 after administration of a dose of Priorix vaccine.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.||Subjects|||Number
789243|NCT00861744|Primary|Number of Subjects With Anti-mumps Virus Antibody Titer Equal to or Above the Cut-off-value.|Anti-mumps virus antibody cut-off-value assessed was ≥ 51 Estimated Dose 50 (ED50). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations <24 ED50 prior to vaccination.|At Day 42 after administration of a dose of Priorix vaccine.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.||Subjects|||Number
789244|NCT00861744|Primary|Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value.|Anti-measles virus antibody cut-off-value assessed was ≥ 200 milli-International Units per milliliter (mIU/mL). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations <150 mIU/mL prior to vaccination.|At Day 42 after administration of a dose of Priorix vaccine.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.||Subjects|||Number
789245|NCT00861757|Secondary|Change From Baseline in Sitting Heart Rate (HR) at 12 Weeks||baseline, 12 weeks|The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis.||beats per minute (bpm)||Standard Deviation|Mean
789246|NCT00861757|Secondary|Change From Baseline in Blood Pressure (Standing) at 12 Weeks||baseline, 12 weeks|All efficacy analyses were performed on an intent-to-treat (ITT) basis. The primary analysis population for efficacy was the Full Analysis Set (FAS) which included all subjects who were randomized and started study medication.||mm Hg||Standard Deviation|Mean
789247|NCT00861757|Secondary|Change From Baseline in Blood Pressure (Sitting) at 12 Weeks||baseline, 12 weeks|The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis.||mm Hg||Standard Deviation|Mean
789248|NCT00861757|Secondary|Change From Baseline in Postvoid Residual Volume (PVR) at 12 Weeks|The PVR is defined as the volume of urine remaining in the bladder after voiding, estimated by ultrasound.|baseline, 12 weeks|The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis.||milliliter (mL)||Standard Deviation|Mean
789317|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) – Blinded Reader 3|BR 3 evaluated the visibility of the lesion(s) on the MTT perfusion map.|up to 2 hours after the injection of study medication|PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.||percentage of participants|||Number
789250|NCT00861757|Secondary|Clinician Global Impression of Improvement (CGI-I) at Week 12|The CGI-I measures clinician's perception of patient improvement at the time of assessment compared with the start of treatment. There are 7 categories with scores ranging from 1 (very much better) to 7 (very much worse). The data are presented as the number of participants in each of the 7 categories: very much better (1); much better (2); a little better (3); no change (4); a little worse (5); much worse (6); very much worse (7).|12 weeks|The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis.||participants|||Number
789251|NCT00861757|Secondary|Patient Global Impression of Improvement (PGI-I) at Week 12|The PGI-I measures the patient's perception of improvement at the time of assessment compared with the start of treatment. There are 7 categories with scores ranging from 1 (very much better) to 7 (very much worse). The data are presented as the number of participants in each of the 7 categories: very much better (1); much better (2); a little better (3); no change (4); a little worse (5); much worse (6); very much worse (7).|12 weeks|The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis.||Participants|||Number
789252|NCT00861757|Secondary|Change From Baseline in Uroflowmetry Parameter: Peak Flow Rate (Qmax) at 12 Weeks|"Qmax: defined as the peak urine flow rate (measured in milliliters per second [mL/second] using standard calibrated flowmeter).
Least Squares Mean values were controlled for Benign Prostatic Hyperplasia (BPH) severity (moderate/severe), prior alpha blocker use (yes/no), country (Japan/Korea/Taiwan), and baseline value."|baseline, 12 weeks|The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis.||milliliter per second (mL/sec)||Standard Error|Least Squares Mean
789253|NCT00861757|Secondary|Change From Baseline in Benign Prostatic Hyperplasia (PBH) Impact Index (BII) at 12 Weeks|The BII is a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores range from 0 to 13; higher scores represent increased perceived impact of benign prostatic hyperplasia-lower urinary tract symptoms on overall health. Least Squares Mean values were controlled for BPH severity (moderate/severe), prior alpha blocker use (yes/no), country (Japan/Korea/Taiwan) and baseline value.|baseline, 12 weeks|The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis.||units on a scale||Standard Error|Least Squares Mean
789254|NCT00861757|Secondary|Change From Baseline in International Prostate Symptom Score (IPSS) Quality of Life (QoL) at 12 Weeks|"Assessment of QoL by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible).
Least Squares Mean values were controlled for Benign Prostatic Hyperplasia severity (moderate/severe), prior alpha blocker use (yes/no), country (Japan/Korea/Taiwan), and baseline value."|baseline, 12 weeks|The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis.||units on a scale||Standard Error|Least Squares Mean
789255|NCT00861757|Secondary|Change From Baseline to 12 Weeks in International Prostate Symptom Score (IPSS) Subscore (Storage [Irritative] and Voiding [Obstructive])|IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 0 (few obstructive symptoms) to 5 (frequent obstructive symptoms); 4 questions of the obstructive score range from 0 to 20. IPSS irritative subscore is the sum of Questions 2, 4 and 7 of IPSS questionnaire. Scores range from 0 (no irritative symptoms) to 5 (frequent irritative symptoms); 3 questions of the irritative subscore range from 0 to 15. Least Squares Mean values were controlled for prior alpha blocker use (yes/no), country (Japan/Korea/Taiwan), and baseline value.|baseline, 12 weeks|The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis.||units on a scale||Standard Error|Least Squares Mean
789256|NCT00861757|Primary|Change From Baseline in International Prostate Symptom Score (IPSS) at 12 Weeks|"The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.
Least Squares Mean values were controlled for prior alpha blocker use (yes/no), country (Japan/Korea/Taiwan) and baseline value."|baseline, 12 weeks|The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis.||Units on a scale||Standard Error|Least Squares Mean
789257|NCT00861913|Secondary|Duration of Response|The date at which the objective status is first noted to be either a Complete Response (CR) or Partial Response (PR) to the date progression is documented, assessed up to 5 years.|From time of documented response to the date progression is documented, assessed up to 5 years.|There was one response and therefore median duration of response was not analyzed.|||||
789258|NCT00861913|Secondary|Progression Free Survival|Progression free survival is defined as the time from registration to the time of progression or death, whichever occurs first. Estimated using the method of Kaplan-Meier.|From registration to documentation of disease progression, assessed up to 5 years|||months||95% Confidence Interval|Median
789259|NCT00861913|Secondary|Overall Survival|Overall survival time is defined as the time from registration to the time of death due to any cause. Estimated using the method of Kaplan-Meier.|From registration to death due to any cause, assessed up to 5 years|||months||95% Confidence Interval|Median
789260|NCT00861913|Primary|Toxicity|Toxicity is defined as any grade 3 or higher adverse event as assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and at least possibly related to treatment. The maximum grade for each type of toxicity will be recorded for each patient. We report the number of patients experiencing a grade 3 or higher adverse event at least possibly related to treatment.|Up to 5 years|||participants|||Number
789297|NCT00862251|Primary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Statin (Simvastatin or Atorvastatin).||Baseline and Week 6|Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data.||Percent change||95% Confidence Interval|Least Squares Mean
789261|NCT00861913|Primary|Tumor Response Rate|"Tumor response rate is defined as the number of eligible patients whose disease status meets the Response Evaluation Criteria In Solid Tumors (RECIST) criteria for compete response (CR) or partial response (PR) divided by the number of evaluable patients. A ninety percent confidence interval for the true response proportion will be calculated assuming that the number of confirmed tumor responses follows a binomial distribution and using the Duffy-Santner approach.
Complete Response (CR): Disappearance of all target lesions.
Partial Response (PR): At least a 30% decrease in the sum of the largest dimension (LD) of target lesions taking as reference the baseline sum LD."|Up to 5 years|||percentage of patients||90% Confidence Interval|Number
789262|NCT00862082|Secondary|Pharmacokinetics (AUC) of PR104 and PR104 Metabolites in Cohort 2 (550 mg/m^2 Dose Group)||Day 1 of Cycles 1 and 2|Participation in PK sampling was optional to subjects, therefore not all subjects in the study were analyzed.||ng.h/ml||Standard Deviation|Mean
789263|NCT00862082|Secondary|Pharmacokinetics (T1/2) of PR104 and PR104 Metabolites in Cohort 2 (550 mg/m^2 Dose Group)||Day 1 of Cycles 1 and 2|Participation in PK sampling was optional to subjects, therefore not all subjects in the study were analyzed.||hr||Standard Deviation|Mean
789264|NCT00862082|Secondary|Pharmacokinetics (Cmax) of PR104 and PR104 Metabolites in Cohort 2 (550 mg/m^2 Dose Group)||Day 1 of Cycles 1 and 2|Participation in PK sampling was optional to subjects, therefore not all subjects in the study were analyzed.||ng/ml||Standard Deviation|Mean
789265|NCT00862082|Secondary|Pharmacokinetics [Area Under the Curve(AUC)] of PR104 and PR104 Metabolites in Cohort 1 (770 mg/m^2 Dose Group)||Day 1 of Cycles 1 and 2|Participation in PK sampling was optional to subjects, therefore not all subjects in the study were analyzed.||ng.h/ml||Standard Deviation|Mean
789266|NCT00862082|Secondary|Pharmacokinetics [Half Life (T1/2)] of PR104 and PR104 Metabolites in Cohort 1 (770 mg/m^2 Dose Group)||Day 1 of Cycles 1 and 2|Participation in PK sampling was optional to subjects, therefore not all subjects in the study were analyzed.||hr||Standard Deviation|Mean
789267|NCT00862082|Secondary|Pharmacokinetics [Maximum Plasma Concentration (Cmax)] of PR104 and PR104 Metabolites in Cohort 1 (770 mg/m^2 Dose Group)||Day 1 of Cycles 1 and 2|Participation in pharmacokinetic (PK) sampling was optional to subjects, therefore not all subjects in the study were analyzed.||ng/ml||Standard Deviation|Mean
789268|NCT00862082|Secondary|Safety and Tolerability: Serious Adverse Events|The number of participants with at least one Serious Adverse Event was measured.|30 days following the last administration of study treatment|||participants|||Number
789269|NCT00862082|Primary|Maximum Tolerated Dose (MTD) of PR104 When Used in Combination With Standard Dose Sorafenib in the Phase I Population||4 weeks (1 cycle)|||mg/m2|||Number
789270|NCT00862121|Secondary|Relative Change From Baseline to Week 10 in Estimated Creatinine Clearance|A lower creatinine clearance indicates worsening of renal function. Creatinine clearance was estimated from serum creatinine levels, using the Cockcroft-Gault formula.|At Week 10, end of treatment|Safety Analysis Set (OC). Descriptive statistics only.||mL/min||Standard Deviation|Mean
789271|NCT00862121|Secondary|Relative Change From Baseline to Each Visit in Work Productivity & Activity Impairment Questionnaire (WPAI_CD) Score Item 5 (Work Productivity)|The WPAI_CD Item 5 measures the impact of Crohn's disease on work productivity (while working). The score is recorded by the patient on a visual analog scale, from 0 to 10. Lower scores are better, while higher scores indicate greater negative effect on work productivity.|Within the 10 week treatment period|Full Analysis Set (OC). Descriptive statistics only.||WPAI_CD Item 5 score||Standard Deviation|Mean
789272|NCT00862121|Secondary|Relative Change From Baseline to Each Visit in Inflammatory Bowel Disease Questionnaire (IBDQ) Score|The IBDQ is a measure of the impact of inflammatory bowel disease (IBD) on health-related quality-of-life (HRQL; mood, social activities, daily life, and IBD-related health worries). Higher scores are better; Total IBDQ score can range from 32 (very poor HRQL) to 224 (perfect HRQL).|Within the 10 week treatment period|Full Analysis Set (OC). Descriptive statistics only.||IBDQ score||Standard Deviation|Mean
789273|NCT00862121|Secondary|Relative Change From Baseline to Each Visit in Serum C-reactive Protein (CRP)|Serum CRP is a laboratory measure of acute inflammation. Higher values are worse.|Within the 10 week treatment period|Full Analysis Set (OC). Descriptive statistics only.||mg/L||Standard Deviation|Mean
789274|NCT00862121|Secondary|Relative Change From Baseline to Week 10 in Fecal Calprotectin|Fecal calprotectin is an inflammatory marker for the gastrointestinal tract. Higher values indicate more serious inflammation.|At Week 10, end of treatment|Full Analysis Set (FAS), observed cases (OC), descriptive statistics only.||microgram/gram faeces||Standard Deviation|Mean
789275|NCT00862121|Primary|Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 10.|The Crohn's Disease Activity Index (CDAI) is a composite score to quantify symptoms of Crohn's disease. It has a range of 0-600; higher scores are worse. A responder is defined as a participant who achieved a reduction in the CDAI score to <150 or a decrease in CDAI score of at least 70.|At Week 10, end of treatment|The percentage of CDAI responders at Week 10 was analysed for the FAS (treated participants with post-baseline CDAI), Last Observation Carried Forward (LOCF).||percentage of participants|||Number
789276|NCT00862134|Secondary|Positive Aldo-keto Reductase 1C3 (AKR1C3) Expression in Participating Patients|"AKR1C3 was evaluated on a semi-quantitative scale, and the percentage of cells staining at each of the following four levels was recorded: 0 (unstained), 1+ (weak staining), 2+ (moderate staining) and 3+ (strong staining).
Patients with a strong staining score (3+) were considered to be AKR1C3 positive"|Within 1 year of enrollment|||participants|||Number
789277|NCT00862134|Secondary|Safety and Tolerability: Serious Adverse Events|The number of participants with at least one Serious Adverse Event was measured.|30 days following last administration of study treatment|||participants|||Number
789278|NCT00862134|Primary|Number of Participants That Achieved a Response (Complete or Partial) After Receiving PR104/Docetaxel Versus Docetaxel Alone|Defined as the number of subjects with complete response (CR) or partial response (PR) using Response Evaluation Criteria in Solid Tumors (RECIST) criteria|Participants were followed for the duration on study, an average of 4 months|||participants|||Number
789298|NCT00862277|Primary|Geometric Mean Titers of Serum Bactericidal Antibody Assay Using Baby Rabbit Complement (SBA-BR) at Enrollment||Day 0|Serum Bactericidal Assay Baby Rabbit Complement antibody titers to each of the 4 meningococcal serogroups in the vaccine were evaluated in the per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
789279|NCT00862186|Primary|Change From Baseline in Fatigue Scale-Adolescent (FS-A) Score Categorized According to 1-5 Rating Scale of Resource Use and Resource Helpfulness.|The FS-A is a 14-item self-report instrument which measures on a 5 point scale ranging from ‘1 - not at all’ to ‘5 - all the time’ the extent to which each of 14 statements describes how the respondent has been feeling during the past 7 days (Hinds et al., 2007). The potential score range is 14-70; higher scores represent greater fatigue (Hinds et al., 2007). The scores (1 through 5) on the Likert-type scales for resource use and resource helpfulness were determined at each post baseline time point, as were change from baseline values for the FS-A. All FS-A change from baseline values, per Resource Use or Resource Helpfulness Categorization, were combined regardless of post-baseline time point.|baseline and weekly up to 8 weeks|||units on a scale||Full Range|Median
789280|NCT00862251|Secondary|Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP)||Baseline and Week 6|Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data.||Percent change||95% Confidence Interval|Least Squares Mean
789281|NCT00862251|Secondary|Percent Change From Baseline in Apo B/Apo A-I Ratio||Baseline and Week 6|Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data.||Percent change||95% Confidence Interval|Least Squares Mean
789282|NCT00862251|Secondary|Percent Change From Baseline Apolipoprotein A-I (Apo A-I)||Baseline and Week 6|Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data.||Percent change||95% Confidence Interval|Least Squares Mean
789283|NCT00862251|Secondary|Percent Change From Baseline in Apolipoprotein B (Apo B)||Baseline and Week 6|Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data.||Percent change||95% Confidence Interval|Least Squares Mean
789284|NCT00862251|Secondary|Percent Change From Baseline in Non-HDL-C/HDL-C Ratio||Baseline and Week 6|Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data.||percent change||95% Confidence Interval|Least Squares Mean
789285|NCT00862251|Secondary|Percent Change From Baseline in TC/HDL-C Ratio||Baseline and Week 6|Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data.||Percent change||95% Confidence Interval|Least Squares Mean
789286|NCT00862251|Secondary|Percent Change From Baseline in LDL-C/HDL-C Ratio||Baseline and Week 6|Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data.||Percent change||95% Confidence Interval|Least Squares Mean
789287|NCT00862251|Secondary|Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)||Baseline and Week 6|Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data.||Percent change||95% Confidence Interval|Least Squares Mean
789288|NCT00862251|Secondary|Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)||Baseline and Week 6|Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data.||percent change||95% Confidence Interval|Least Squares Mean
789289|NCT00862251|Secondary|Percent Change From Baseline in Triglycerides||Baseline and Week 6|Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data.||Percent change||95% Confidence Interval|Least Squares Mean
789290|NCT00862251|Secondary|Percent Change From Baseline in Total Cholesterol (TC)||Baseline and Week 6|Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data.||Percent Change||95% Confidence Interval|Least Squares Mean
789291|NCT00862251|Secondary|In Participants Treated With Atorvastatin at Baseline, Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L)||Week 6|Analysis performed on subpopulation of participants who were previously treated with atorvastatin 10 mg and were switched to either Ezetimibe/simvastatin or had atorvastatin dose doubled to 20 mg||participants|||Number
789292|NCT00862251|Secondary|In Participants Treated With Simvastatin at Baseline, Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L)||Week 6|Analysis performed on subpopulation of participants who were previously treated with simvastatin 20 mg and were switched to either Ezetimibe/simvastatin or had simvastatin dose doubled to 40 mg||participants|||Number
789293|NCT00862251|Secondary|Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L)||Week 6|Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data.||participants|||Number
789294|NCT00862251|Secondary|Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Switching Treatment to Rosuvastatin||Baseline and Week 6|Efficacy data were analyzed primarily based upon the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data.||Percent change||95% Confidence Interval|Least Squares Mean
789295|NCT00862251|Secondary|In Participants Treated With Atorvastatin at Baseline, Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Atorvastatin||Baseline and Week 6|Analysis performed on subpopulation of participants who were previously treated with atorvastatin 10 mg and were switched to either Ezetimibe/simvastatin or had atorvastatin dose doubled to 20 mg||Percent change||95% Confidence Interval|Least Squares Mean
789296|NCT00862251|Secondary|In Participants Treated With Simvastatin at Baseline, Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Simvastatin||Baseline and Week 6|Analysis performed on subpopulation of participants who were previously treated with simvastatin 20 mg and were switched to either Ezetimibe/simvastatin or had simvastatin dose doubled to 40 mg||Percent change||95% Confidence Interval|Least Squares Mean
789299|NCT00862277|Primary|Percentage of Participants With Serum Bactericidal Antibody Titers for Meningococcal Serogroups A, C, Y, and W-135 at ≥ 8 and ≥ 128 at Enrollment||Day 0|Serum Bactericidal Assay Baby Rabbit Complement antibody titers to each of the 4 meningococcal serogroups in the vaccine were evaluated in the per-protocol population.||Percentage of Participants|||Number
789300|NCT00862459|Secondary|Contrast to Noise Ratio (CNR) of Lesion/Gray Matter and Lesion/White Matter|CNR between lesion/gray matter and lesion/white matter in the perfusion imaging was defined as the signal intensity (SI) difference between lesion and gray or white matter divided by the standard deviation of background noise. An independent radiologist evaluated the gadobutrol-enhanced perfusion MRI for signal intensity.|up to 2 hours after the injection of study medication|PPS (excluding subjects who had no lesion detected, and those who had no value determined)||CNR||Standard Deviation|Mean
789301|NCT00862459|Secondary|Evaluation of MRI Tumor Grade Agreement With Biopsy Results by Dose Group|The blinded readers gave an estimation of the tumor grade of brain tumors (low grade [I or II] or high grade [III or IV]) in terms of malignancy using the information obtained by perfusion imaging, which was compared to the biopsy sample results|up to 2 hours after the injection of study medication|PPS participants with tumors||Percentage of accuracy|||Number
789302|NCT00862459|Secondary|Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) – Blinded Reader|The blinded reader evaluated if artifacts were present on the PF perfusion map and recorded the type of the major artifact. EPI: echo-planar imaging; T2: transversal relaxation time|up to 2 hours after the injection of study medication|PPS||percentage of participants|||Number
789303|NCT00862459|Secondary|Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) – Blinded Reader|The blinded reader evaluated if artifacts were present on the MTT perfusion map and recorded the type of the major artifact. EPI: echo-planar imaging; T2: transversal relaxation time|up to 2 hours after the injection of study medication|PPS||percentage of participants|||Number
789304|NCT00862459|Secondary|Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) – Blinded Reader|The blinded reader evaluated if artifacts were present on the TTP perfusion map and recorded the type of the major artifact. EPI: echo-planar imaging; T2: transversal relaxation time|up to 2 hours after the injection of study medication|PPS||percentage of participants|||Number
789305|NCT00862459|Secondary|Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) – Blinded Reader|The blinded reader evaluated if artifacts were present on the CBF perfusion map and recorded the type of the major artifact. EPI: echo-planar imaging; T2: transversal relaxation time|up to 2 hours after the injection of study medication|PPS||percentage of participants|||Number
789306|NCT00862459|Secondary|Evaluation of Perfusion Map Artifacts (Corrected Cerebral Blood Volume (CBV)) – Blinded Reader|The blinded reader evaluated if artifacts were present on the corrected CBV perfusion map and recorded the type of the major artifact. EPI: echo-planar imaging; T2: transversal relaxation time. CBV is the fraction of the tissue volume occupied by the blood.|up to 2 hours after the injection of study medication|PPS||percentage of participants|||Number
789307|NCT00862459|Secondary|Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) – Blinded Reader|The blinded reader evaluated if artifacts were present on the uncorrected CBV perfusion map and recorded the type of the major artifact. EPI: echo-planar imaging; T2: transversal relaxation time.|up to 2 hours after the injection of study medication|PPS||percentage of participants|||Number
789308|NCT00862459|Secondary|Evaluation of Perfusion Map Parameter Value (Permeability Factor (PF)) – Independent Radiologist|The independent radiologist determined the PF for each lesion|up to 2 hours after the injection of study medication|PPS (excluding subjects whose parameter map value was not determined)||seconds||Standard Deviation|Mean
789309|NCT00862459|Secondary|Evaluation of Perfusion Map Parameter Value (Mean Transit Time (MTT)) – Independent Radiologist|The independent radiologist determined the MTT for each lesion. The MTT is the time (seconds) for contrast to pass through tissues.|up to 2 hours after the injection of study medication|PPS (excluding subjects whose parameter map value was not determined)||seconds||Standard Deviation|Mean
789310|NCT00862459|Secondary|Evaluation of Perfusion Map Parameter Value (Time to Peak (TTP)) – Independent Radiologist|The independent radiologist determined the TTP for each lesion. TTP is the delay between the arrival of the contrast agent bolus arrival time and the peak of the concentration curve.|up to 2 hours after the injection of study medication|PPS (excluding subjects whose parameter map value was not determined)||seconds||Standard Deviation|Mean
789311|NCT00862459|Secondary|Evaluation of Perfusion Map Parameter Value (Cerebral Blood Flow (CBF)) – Independent Radiologist|The independent radiologist determined the CBF for each lesion. CBF is the volume of blood passing through tissue per unit of time.|up to 2 hours after the injection of study medication|PPS (excluding subjects whose parameter map value was not determined)||mL / 100 g tissue / min.||Standard Deviation|Mean
789312|NCT00862459|Secondary|Evaluation of Perfusion Map Parameter Value (Corrected Cerebral Blood Volume (CBV)) – Independent Radiologist|The independent radiologist determined the corrected CBV for each lesion. CBV is the volume of blood in the tissue.|up to 2 hours after the injection of study medication|PPS (excluding subjects whose parameter map value was not determined)||mL / 100 g tissue||Standard Deviation|Mean
789313|NCT00862459|Secondary|Evaluation of Perfusion Map Parameter Value (Uncorrected Cerebral Blood Volume (CBV)) – Independent Radiologist|The independent radiologist determined the uncorrected CBV for each lesion. CBV is the volume of blood in the tissue.|up to 2 hours after the injection of study medication|PPS (excluding subjects whose parameter map value was not determined)||mL / 100 g tissue||Standard Deviation|Mean
789314|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Permeability Factor (PF)) – Blinded Reader 3|BR 3 evaluated the visibility of the lesion(s) on the PF perfusion map.|up to 2 hours after the injection of study medication|PPS||percentage of participants|||Number
789315|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Permeability Factor (PF) – Blinded Reader 2|BR 2 evaluated the visibility of the lesion(s) on the PF perfusion map.|up to 2 hours after the injection of study medication|PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.||percentage of participants|||Number
789316|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Permeability Factor (PF) – Blinded Reader 1|BR 1 evaluated the visibility of the lesion(s) on the PF perfusion map.|up to 2 hours after the injection of study medication|PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.||percentage of participants|||Number
789318|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) – Blinded Reader 2|BR 2 evaluated the visibility of the lesion(s) on the MTT perfusion map.|up to 2 hours after the injection of study medication|PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.||percentage of participants|||Number
789319|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) – Blinded Reader 1|BR 1 evaluated the visibility of the lesion(s) on the MTT perfusion map.|up to 2 hours after the injection of study medication|PPS||percentage of participants|||Number
789320|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Time to Peak (TTP)) – Blinded Reader 3|BR 3 evaluated the visibility of the lesion(s) on the TTP perfusion map.|up to 2 hours after the injection of study medication|PPS||percentage of participants|||Number
789321|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Time to Peak (TTP)) – Blinded Reader 2|BR 2 evaluated the visibility of the lesion(s) on the TTP perfusion map.|up to 2 hours after the injection of study medication|PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.||percentage of participants|||Number
789322|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Time to Peak (TTP)) – Blinded Reader 1|BR 1 evaluated the visibility of the lesion(s) on the TTP perfusion map.|up to 2 hours after the injection of study medication|PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.||percentage of participants|||Number
789323|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) – Blinded Reader 3|BR 3 evaluated the visibility of the lesion(s) on the CBF perfusion map.|up to 2 hours after the injection of study medication|PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.||percentage of participants|||Number
789324|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) – Blinded Reader 2|BR 2 evaluated the visibility of the lesion(s) on the CBF perfusion map.|up to 2 hours after the injection of study medication|PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.||percentage of participants|||Number
789325|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) – Blinded Reader 1|BR 1 evaluated the visibility of the lesion(s) on the CBF perfusion map.|up to 2 hours after the injection of study medication|PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.||percentage of participants|||Number
789326|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) – Blinded Reader 3|BR 3 evaluated the visibility of the lesion(s) on the corrected CBV perfusion map.|up to 2 hours after the injection of study medication|PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.||percentage of participants|||Number
789327|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) – Blinded Reader 2|BR 2 evaluated the visibility of the lesion(s) on the corrected CBV perfusion map.|up to 2 hours after the injection of study medication|PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.||percentage of participants|||Number
789328|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) – Blinded Reader 1|BR 1 evaluated the visibility of the lesion(s) on the corrected CBV perfusion map.|up to 2 hours after the injection of study medication|PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.||percentage of participants|||Number
789329|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) – Blinded Reader 3|BR 3 evaluated the visibility of the lesion(s) on the uncorrected CBV perfusion map.|up to 2 hours after the injection of study medication|PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.||percentage of participants|||Number
789330|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) – Blinded Reader 2|BR 2 evaluated the visibility of the lesion(s) on the uncorrected CBV perfusion map.|up to 2 hours after the injection of study medication|PPS. Due to rounding, the sum of percentages may range from 99.9 to 100.1.||percentage of participants|||Number
789331|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume [CBV]) – Blinded Reader 1|BR 1 evaluated the visibility of the lesion(s) on the uncorrected CBV perfusion map.|up to 2 hours after the injection of study medication|PPS, Due to rounding, the sum of the percentages may range from 99.9 to 100.1.||percentage of participants|||Number
789332|NCT00862459|Secondary|Evaluation of the Diagnostic Confidence Based on Unenhanced MRI and Combined Unenhanced and Enhanced MRI|The diagnostic confidence, the level of certainty in a diagnosis, was determined based on the average of the blinded readers.|up to 2 hours after the injection of study medication|PPS, Due to rounding, the sum of the percentages may range from 99.9 to 100.1.||percentage of participants|||Number
789333|NCT00862459|Secondary|Evaluation of the Correct Diagnosis Following Gadobutrol-enhanced and Unenhanced MRI|The gadobutrol-enhanced and unenhanced MRI diagnoses of the average reader were compared to the final diagnosis.|up to 2 hours after the injection of study medication|PPS||percentage of exact matches|||Number
789334|NCT00862459|Secondary|Accuracy Comparison of Gadobutrol Doses – Detection of Matched Enhanced Lesions: Blinded Reader 3|The percent accuracy (total number of lesions matching the comparator divided by the total number of lesions identified by gadobutrol) comparison of the 0.03 and 0.1 mmol/kg gadobutrol doses and the 0.1 and 0.3 mmol/kg gadobutrol doses using detection of all comparator-detected matched enhanced lesions was performed for BR 3|up to 2 hours after the injection of study medication|PPS(excluding subjects with no enhanced lesion detected)||percentage of lesions|||Number
789335|NCT00862459|Secondary|Accuracy Comparison of Gadobutrol Doses – Detection of Matched Enhanced Lesions: Blinded Reader 2|The percent accuracy (total number of lesions matching the comparator divided by the total number of lesions identified by gadobutrol) comparison of the 0.03 and 0.1 mmol/kg gadobutrol doses and the 0.1 and 0.3 mmol/kg gadobutrol doses using detection of all comparator-detected matched enhanced lesions was performed for BR 2|up to 2 hours after the injection of study medication|PPS (excluding subjects with no enhanced lesion detected)||percentage of lesions|||Number
789336|NCT00862459|Secondary|Accuracy Comparison of Gadobutrol Doses – Detection of Matched Enhanced Lesions: Blinded Reader 1|The percent accuracy (total number of lesions matching the comparator divided by the total number of lesions identified by gadobutrol) comparison of the 0.03 and 0.1 mmol/kg gadobutrol doses and the 0.1 and 0.3 mmol/kg gadobutrol doses using detection of all comparator-detected matched enhanced lesions was performed for BR 1|up to 2 hours after the injection of study medication|PPS (excluding subjects with no enhanced lesion detected)||percentage of lesions|||Number
789337|NCT00862459|Secondary|Accuracy Comparison of Gadobutrol Doses – Detection of Matched Lesions: Blinded Reader 3|The percent accuracy (total number of lesions matching the comparator divided by the total number of lesions identified by gadobutrol) comparison of the 0.03 and 0.1 mmol/kg gadobutrol doses and the 0.1 and 0.3 mmol/kg gadobutrol doses using detection of all comparator-detected matched lesions was performed for BR 3|up to 2 hours after the injection of study medication|PPS (excluding subjects with no lesion detected)||percentage of lesions|||Number
789338|NCT00862459|Secondary|Accuracy Comparison of Gadobutrol Doses – Detection of Matched Lesions: Blinded Reader 2|The percent accuracy (total number of lesions matching the comparator divided by the total number of lesions identified by gadobutrol) comparison of the 0.03 and 0.1 mmol/kg gadobutrol doses and the 0.1 and 0.3 mmol/kg gadobutrol doses using detection of all comparator-detected matched lesions was performed for BR 2|up to 2 hours after the injection of study medication|PPS (excluding subjects with no lesion detected)||percentage of lesions|||Number
789339|NCT00862459|Secondary|Accuracy Comparison of Gadobutrol Doses – Detection of Matched Lesions: Blinded Reader 1|The percent accuracy (total number of lesions matching the comparator divided by the total number of lesions identified by gadobutrol) comparison of the 0.03 and 0.1 mmol/kg gadobutrol doses and the 0.1 and 0.3 mmol/kg gadobutrol doses using detection of all comparator-detected matched lesions was performed for blinded reader (BR) 1.|up to 2 hours after the injection of study medication|PPS (excluding subjects with no lesion detected)||percentage of lesions|||Number
789340|NCT00862459|Primary|Contrast to Noise Ratio (CNR) Between White and Gray Matter With Gadobutrol Perfusion MRI|CNR between white and gray matter in the perfusion imaging was defined as the signal intensity (SI) difference between white and gray matter divided by the standard deviation of the SI of white matter. An independent radiologist evaluated the gadobutrol-enhanced perfusion MRI for signal intensity.|up to 2 hours after the injection of study medication|PPS (excluding participants with insufficient images)||CNR||Standard Deviation|Mean
789341|NCT00862459|Primary|Assessment of Internal Morphology|The blinded readers assessed the degree of information available about internal morphology and structure for each lesion on a 3-point scale where 1 = poor and 3 = good, which was then averaged to produce an average reader score.|up to 2 hours after the injection of study medication|PPS (excluding subjects with no lesion detected)||scores on a scale||Standard Deviation|Mean
789342|NCT00862459|Primary|Assessment of Border Delineation|The blinded readers assessed the delineation for each lesion on a 4-point scale where 1 = none and 4 = excellent, which was then averaged to produce an average reader score.|up to 2 hours after the injection of study medication|PPS (excluding subjects with no lesion detected)||scores on a scale||Standard Deviation|Mean
789343|NCT00862459|Primary|Assessment of Lesion Contrast Enhancement|The blinded readers assessed the degree of contrast enhancement for each lesion on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement, which was then averaged to produce an average reader score.|up to 2 hours after the injection of study medication|PPS (excluding subjects with no lesion detected)||scores on a scale||Standard Deviation|Mean
789344|NCT00862459|Primary|Difference in Number of Lesions Detected in Pre-contrast and Combined Pre-/Post-contrast MRI.|Three blinded readers evaluated the unenhanced MRI sets and the combined unenhanced/gadobutrol-enhanced MRI sets to evaluate the number of lesions, which was then averaged to produce an average reader value.|up to 2 hours after the injection of study medication|PPS (excluding one participant with insufficient images)||Lesions per participant||Standard Deviation|Mean
789345|NCT00862459|Primary|Categorical Visualization Score (CVS)|The primary visualization variables (number [no.] of lesions detected, border delineation, contrast enhancement, internal morphology) were condensed to a composite score (CVS). Each variable was considered a category; the CVS was calculated as: CVS=(No. of categories with increase over precontrast)–(No. of categories with decrease over precontrast). The possible outcomes of the CVS for a participant and each reader were in the range of - 3 to +4. The CVS was averaged across the 3 blinded readers, producing 1 mean CVS per participant. The higher the CVS, the more effective the treatment.|up to 2 hours after the injection of study medication|The per protocol set (PPS), which included all participants with valid images who received +/-10% of the intended dose of study drug and had no major protocol or Magnetic Resonance Imaging (MRI) procedure deviations (excluding one participant with insufficient images)||Scores on a scale||Standard Deviation|Mean
789346|NCT00862537|Primary|Change in Parkinson's Disease Questionnaire-39 Single Index Score (PDQ-39SI)From Baseline to Study Endpoint of 11 Months|The Parkinson’s Disease Questionnaire (PDQ-39) is a 39-item quality of life questionnaire for patients with Parkinson’s Disease (PD) that evaluates the 8 dimensions of mobility, activities of daily living, emotional well-being, stigma, social support, cognition, and communication. The PDQ-39 Single Index (SI) score is the weighted addition of scores on all 8 dimension and ranges from 0 (no disease impact) to 100 (severe disease impact).|baseline and 11 months|||scores on a scale||Standard Deviation|Mean
789347|NCT00862563|Secondary|Wechsler Memory Scale-3rd Ed. Spatial Span|WMS Spatial Span test measures working memory for a spatial sequence of numbers. This assesses visual working memory. Age adjusted scaled scores are presented. Score may range between 1 and 19, with lower scores indicating greater impairment in performance.|Baseline, Week 12|Alcohol Dependent Subjects. Number of participants analyzed represent the number for whom Week 12 data was available.||units on a scale||Standard Error|Mean
789348|NCT00862563|Secondary|Wechsler Memory Scales (WMS)-3d Ed Digit Span-Age Adjusted Total|WMS Digit Span is a measure of working memory. Subjects respond by repeating lists of number sequences presented by the test administrator. Age adjusted scores are presented below. Scores may range between 1 and 19, with lower scores indicating poorer performance on the task.|Baseline, Week 12|Alcohol Dependent Subjects. Number of participants analyzed represent the number for whom Week 12 data was available.||units on a scale||Standard Error|Mean
789349|NCT00862563|Secondary|COWAT-Category|Number of words produced by subjects over 60 seconds for a semantic category (Animals). The COAWAT-Category sub-test provides a measure of verbal fluency. Mean value shown are actual means for the number of words produced.|Baseline, Week12|Alcohol Dependent Subjects. Number of participants analyzed represent the number for whom Week 12 data was available.||Number of Words Produced||Standard Error|Mean
789350|NCT00862563|Secondary|Controlled Word Association Test (COWAT)- Letter Fluency|Number of words generated that start with a set of 3 letters. The COWAT provides a measure of verbal fluency. Actual means for COWAT results are shown.|Baseline & Week 12|Alcohol Dependent Subjects. Number of participants analyzed represent the number for whom Week 12 data was available.||Number of Words Produced||Standard Error|Mean
789351|NCT00862563|Secondary|Percent Days Drinking|Mean percent days drinking for Weeks 10, 11, 12. A drinking day is considered to be a day in which 1 or more drinks have been consumed. Means are model generated least means squares values obtained from a two-way repeated measures analysis from data obtained from Weeks 1 through 12, with Week as the within subject factor and treatment group as the between group factor.|Weeks 10, 11, 12|Alcohol dependent subjects. Alcohol dependent subjects. Number of participants analyzed are provided for the number of subjects for data that was available for the timeframe for the specific analyses, i.e. Weeks 10,11,12.||Percentage of Days/ Week||Standard Error|Mean
789352|NCT00862563|Secondary|Mean Percent Days Heavy Drinking|Mean weekly values for each treatment group for percent days heavy drinking. Heavy drinking was defined as 4 or more drinks per day for women and 5 or more drinks per day for men.|Weeks 10, 11, 12|Alcohol dependent subjects. Alcohol dependent subjects. Number of participants analyzed are provided for the number of subjects for data that was available for the time frame for the specific analyses, i.e. Weeks 10,11,12.||Percentage of Days/Week||Standard Error|Mean
789353|NCT00862563|Secondary|AB-Neurotoxicity Scale.|Total Scores AB-Neurotoxicity Scale Week 12. This scale provides subject ratings of anticonvulsant neurotoxic effects. Scores may range 0 to 72, with possibility of an additional 30 points being for complaints not listed in the list of complaints provides. Total scores, therefore, may be as high as 102, with higher scores indicating greater severity of problems. Actual mean scores are shown. Means for the analysis are least means squares values obtained from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.|Week 12|Alcohol dependent subjects.||Scale Scores||Standard Error|Mean
789354|NCT00862563|Primary|The Primary Efficacy Measure is the Mean Number of Drinks Consumed Per Day Over the Period From Treatment Weeks 10 Through 12 When All Study Medications Should be at Their Maximum Steady Levels Based on Their Known Pharmacokinetic Properties.|Mean standard drinks consumed per day for each treatment week, weeks 10 thru 12. Actual mean values obtained are shown. Analyses are based on model generated least squares means for a two -way repeated measures mixed models analysis for data obtained for weeks 1 through 12, with baseline values used as covariates. Week (time) was used as the within subject factor and treatment group was the between group factor.|Weeks 10, 11, 12|Alcohol dependent subjects. Number of participants analyzed are provided for the number of subjects for data that was available for the timeframe for the specific analyses, i.e. Weeks 10,11,12.||Standard Drinks per day||Standard Error|Mean
789355|NCT00862641|Secondary|Percentage of Selected Respiratory Adverse Events|"The selected respiratory Adverse Events are dyspnoea, dyspnoea exertional, obstructive airways disorder, tachypnoea and wheezing.
Subjects may have reported more than one type of Adverse Event."|Within 24 Hours of study drug administration|The number of participants analyzed per arm represents Safety Analysis Set (SAF) which included all randomized subjects who received any amount of study drug.||Percentage of Subjects|||Number
789356|NCT00862641|Secondary|Change From Baseline to the 2 Hour Post-dose Assessment for Oxygen Saturation Measured by Pulse Oximetry|Change from Baseline is calculated as the Hour 2 measurement minus the Baseline measurement.|Baseline and Hour 2|The number of participants analyzed per arm represents Safety Analysis Set (SAF) which included all randomized subjects who received any amount of study drug. The number of participants included in the calculation for each row is noted in the category titles, as “N”.||Percentage of Oxygen Saturation||Standard Deviation|Mean
789357|NCT00862641|Secondary|Change From Baseline to the 2 Hour Post-dose Assessment for FEV1/ FVC Ratio|"FEV1 and FVC data was obtained by spirometry measurements.
Change from Baseline is calculated as the Hour 2 measurement minus the Baseline measurement."|Baseline and Hour 2|"The number of participants analyzed per arm represents Safety Analysis Set (SAF) which included all randomized subjects who received any amount of study drug. The number of participants included in the calculation for each row is noted in the category titles, as N."||Percentage of FEV1 / FVC||Standard Deviation|Mean
789358|NCT00862641|Secondary|Change From Baseline to the 2 Hour Post-dose Assessment for Forced Vital Capacity (FVC)|"FVC data was obtained by spirometry measurements.
Change from Baseline is calculated as the Hour 2 measurement minus the Baseline measurement."|Baseline and Hour 2|The number of participants analyzed per arm represents Safety Analysis Set (SAF) which included all randomized subjects who received any amount of study drug. The number of participants included in the calculation for each row is noted in the category titles, as “N”.||Liters||Standard Deviation|Mean
789359|NCT00862641|Secondary|Change From Baseline to the 2 Hour Post-dose Assessment for FEV1 Percent Predicted|"FEV1 data was obtained by spirometry measurements.
Change from Baseline is calculated as the Hour 2 measurement minus the Baseline measurement."|Baseline and Hour 2|The number of participants analyzed per arm represents Safety Analysis Set (SAF) which included all randomized subjects who received any amount of study drug. The number of participants included in the calculation for each row is noted in the category titles, as “N”.||Percentage of Predicted FEV1||Standard Deviation|Mean
789360|NCT00862641|Secondary|Change From Baseline to the 2 Hour Post-dose Assessment for FEV1 Absolute Values|"FEV1 data was obtained by spirometry measurements.
Change from Baseline is calculated as the Hour 2 measurement minus the Baseline measurement."|Baseline and Hour 2|The number of participants analyzed per arm represents Safety Analysis Set (SAF) which included all randomized subjects who received any amount of study drug. The number of participants included in the calculation for each time point is noted in the category titles, as “N”.||Liters||Standard Deviation|Mean
789361|NCT00862641|Secondary|Use of Short-acting Bronchodilators for Treatment of Symptoms After Study Drug Administration|"The data represents the numbers of subjects using short acting bronchodilators at time of selected Adverse Event (AE).
Short acting bronchodilators are defined as medications coded to drugs for obstructive airway disease.
The selected respiratory symptomatic AEs included the following preferred terms: dyspnoea, dyspnoea exertional, obstructive airways disorder, tachypnoea, & wheezing."|Within 24 Hours of study drug administration|The number of participants analyzed per arm represents Safety Analysis Set (SAF) which included all randomized subjects who received any amount of study drug.||Subjects|||Number
789379|NCT00862784|Secondary|Area Under the Concentration (AUC) at Day 1 of Cycle 1|Due to sparse pharmacokinetic schedule, AUC was not calculated.|Baseline, 1, 168, and 336 hours post infusion on Day 1 (Cycle 1)|No participants were analyzed due to sparse pharmacokinetic schedule.|||||
789380|NCT00862784|Secondary|Maximum Concentration (Cmax) at Day 1 of Cycle 1|Due to sparse pharmacokinetic schedule, Cmax was not calculated.|Baseline, 1, 168, and 336 hours post infusion on Day 1 (Cycle 1)|No participants were analyzed due to sparse pharmacokinetic schedule.|||||
789362|NCT00862641|Secondary|Use of Short-acting Bronchodilators for Treatment of Symptoms After Study Drug Administration|"The data represents the numbers of subjects using short acting bronchodilators at time of selected Adverse Event (AE).
Short acting bronchodilators are defined as medications coded to drugs for obstructive airway disease.
The selected respiratory symptomatic AEs included the following preferred terms: dyspnoea, dyspnoea exertional, obstructive airways disorder, tachypnoea, & wheezing."|Within 2 Hours of study drug administration|The number of participants analyzed per arm represents Safety Analysis Set (SAF) which included all randomized subjects who received any amount of study drug.||Subjects|||Number
789363|NCT00862641|Primary|Percentage of Subjects Who Had a >15% Decrease in Forced Expiratory Volume in 1 Second (FEV1) at the 2-hour Postbaseline Assessment|FEV1 data was obtained by spirometry measures.|2 Hours post dose|The number of participants analyzed per arm represents Safety Analysis Set (SAF) which included all randomized subjects who received any amount of study drug.||Percentage of Subjects|||Number
789364|NCT00862654|Primary|Total Severity Score (TSS): Percent Change From Baseline at Week 4|Total Severity Score (TSS) is sum of erythema, scaling and pruritus severity scores of the lesions evaluated each on a 4-point scale from 0 = None to 3 = Severe by the investigator. So minimum TSS can be 0 and maximum 9.|baseline and week 4|Intent To Treat (ITT) with Last Observation Carried Forward (LOCF)||Percent change||Full Range|Median
789365|NCT00862719|Secondary|Treatment Related Adverse Events Grade 3 or Higher for Non-hematological Toxicity|Number of unique patients who had a treatment related (possible, probable or definite) non-hematological adverse event that was graded 3 or greater.|Transplant (Day 0) up to 3 years|All patients enrolled and received treatment.||participants|||Number
789366|NCT00862719|Secondary|Time to Platelet Engraftment|Time to platelet engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of platelets is defined as the time from day 0 to the first of seven consecutive days after transplantation during which the platelet count is at least 20 x109/l without transfusion support. Only patients who achieved engraftment of platelets will be included in the analysis. The median and 95% confidence intervals will be provided.|Transplant (Day 0) up to 1 year|All patients enrolled and received treatment who achieved platelet recovery/engraftment of platelets.||days||95% Confidence Interval|Median
789367|NCT00862719|Secondary|Time to Neutrophil Engraftment|Time to neutrophil engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of neutrophils is defined as the time from day 0 to the date of the first of three consecutive days after transplantation during which the absolute neutrophils count (ANC) is at least 0.5 x109/l. Patients who did not have neutrophil engraftment before death will be censored at the date of death. The median and 95% confidence intervals will be provided. For the RCD group, all patients engrafted before day +30, except one patient who died at day 28 before engraftment. For the PD group, all patients engrafted before day +100, except one patient who died on day +103 before engraftment. For the 600 mg sitagliptin/12 hours group, two patients engrafted before day +100, and the other two patients died before day +100 before engraftment. The one patient on 600 mg sitagliptin/8 hours died on day +14 before engraftment.|Transplant (Day 0) up to 1 year|All patients enrolled and received treatment.||days||95% Confidence Interval|Median
789368|NCT00862719|Primary|Cumulative Incidence of Patients With Engraftment by Day +30 Following Transplant|Evaluate the efficacy of CD26/DPP-IV inhibition in increasing the cumulative incidence of adult patients with hematological malignancies engrafting by day +30 following transplantation of UCB by 30 percent. The cumulative incidence of patients achieving this will be reported. The value of the estimate will be from bootstrapping 1000 samples with replacement of the data and the 95% confidence interval will be calculated using the percentile method.|Transplant (Day 0) through Day +30|Modified Intent to treat population (mITT) - all patients receiving at least one dose of study drug and receiving REB depleted UCB units only||percentage of participants||95% Confidence Interval|Number
789369|NCT00862745|Primary|Change in Frequency of Urge Urinary Incontinence Episodes at Week 12.||Baseline and Week 12|The population analyzed included all participants receiving at least 1 dose of study intervention.||episodes||Standard Deviation|Mean
789370|NCT00862784|Secondary|Serum Anti-IMC-1121B (Immunogenicity) at Day 1|Data presented are the number of participants with treatment emergent anti-IMC-112B antibodies.|Day 1 (Cycles 1, 5, 9, and 30-day follow-up)|All participants who received any amount of study drug and had serum Anti-IMC-1121B (ramucirumab) evaluated.||participants|||Number
789371|NCT00862784|Secondary|Steady State Volume of Distribution (Vss) at Day 1 of Cycles 5, 9, 13, 17, and 21|Due to sparse pharmacokinetic schedule, Vss was not calculated.|Baseline and 1 hour post infusion on Day 1 (Cycles 5, 9, 13, 17, and 21)|No participants were analyzed due to sparse pharmacokinetic schedule.|||||
789372|NCT00862784|Secondary|Clearance (CL) at Day 1 of Cycles 5, 9, 13, 17, and 21|Due to sparse pharmacokinetic schedule, CL was not calculated.|Baseline and 1 hour post infusion on Day 1 (Cycles 5, 9, 13, 17, and 21)|No participants were analyzed due to sparse pharmacokinetic schedule.|||||
789373|NCT00862784|Secondary|Half-Life (t1/2) at Day 1 of Cycles 5, 9, 13, 17, and 21|Due to sparse pharmacokinetic schedule, t1/2 was not calculated.|Baseline and 1 hour post infusion on Day 1 (Cycles 5, 9, 13, 17, and 21)|No participants were analyzed due to sparse pharmacokinetic schedule.|||||
789374|NCT00862784|Secondary|Area Under the Concentration (AUC) at Day 1 of Cycles 5, 9, 13, 17, and 21|Due to sparse pharmacokinetic schedule, AUC was not calculated.|Baseline and 1 hour post infusion on Day 1 (Cycles 5, 9, 13, 17, and 21)|No participants were analyzed due to sparse pharmacokinetic schedule.|||||
789375|NCT00862784|Secondary|Maximum Concentration (Cmax) at Day 1 of Cycles 5, 9, 13, 17, and 21|Due to sparse pharmacokinetic schedule, Cmax was not calculated.|Baseline and 1 hour post infusion on Day 1 (Cycles 5, 9, 13, 17, and 21)|No participants were analyzed due to sparse pharmacokinetic schedule.|||||
789376|NCT00862784|Secondary|Steady State Volume of Distribution (Vss) at Day 1 of Cycle 1|Due to sparse pharmacokinetic schedule, Vss was not calculated.|Baseline, 1, 168, and 336 hours post infusion Day 1 (Cycle 1)|No participants were analyzed due to sparse pharmacokinetic schedule.|||||
789377|NCT00862784|Secondary|Clearance (CL) at Day 1 of Cycle 1|Due to sparse pharmacokinetic schedule, CL was not calculated.|Baseline, 1, 168, and 336 hours post infusion on Day 1 (Cycle 1)|No participants were analyzed due to sparse pharmacokinetic schedule.|||||
789378|NCT00862784|Secondary|Half-Life (t1/2) at Day 1 of Cycle 1|Due to sparse pharmacokinetic schedule, t1/2 was not calculated.|Baseline, 1, 168, and 336 hours post infusion on Day 1 (Cycle 1)|No participants were analyzed due to sparse pharmacokinetic schedule.|||||
789381|NCT00862784|Secondary|Number of Participants With IMC-1121B (Ramucirumab)-Related Severe Adverse Events (SAEs)|Data presented are the number of participants who experienced SAEs, adverse events (AEs) resulting in death and AEs leading to discontinuation of treatment, that were considered to be related to IMC-1121B (ramucirumab) by the investigators. A summary of SAEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.|First dose to 25.2 months|All participants who received any amount of study drug.||participants|||Number
789382|NCT00862784|Secondary|Number of Participants With IMC-1121B (Ramucirumab)-Related Adverse Events (AEs)|Data presented are the number of participants who experienced AEs of any grade and AEs of Grade ≥3 based on National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3.0 (NCI-CTCAE v 3.0), that were considered to be related to IMC-1121B (ramucirumab) by the investigators. A summary of serious AEs (SAEs) and all other non-serious AEs regardless of causality, is located in the Reported Adverse Events module.|First dose to 25.2 months|All participants who received at any amount of study drug.||participants|||Number
789383|NCT00862784|Secondary|Duration of Response|The duration of response was defined as the time from first objective status assessment of complete response (CR) or partial response (PR) to the first time of progression or death as a result of any cause. CR or PR is classified by the investigators according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. CR is disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesion.|Time of response to time of measured progressive disease up to 22.2 months|All participants who received any amount of study drug who had CR and PR.||months||95% Confidence Interval|Median
789384|NCT00862784|Secondary|Overall Survival (OS)|OS was defined as the time from first dose to the date of death due to any cause. For participants who were alive or were lost to follow-up, OS was censored on the last date the participant was known to be alive.|First dose to death due to any cause up to 28.1 months|All participants who received any amount of study drug. The number of participants censored was 18.||months||95% Confidence Interval|Median
789385|NCT00862784|Secondary|Percentage of Participants With Complete Response or Partial Response [Objective Response Rate (ORR)]|ORR is the percentage of participants with a confirmed complete response (CR) + partial response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. CR is disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesion. ORR is calculated as a total number of participants with CR or PR from the start of study treatment until disease progression or recurrence divided by the total number of participants treated, then multiplied by 100.|First dose to date of objective progressive disease up to 23.8 months|All participants who received any amount of study drug.||percentage of participants||95% Confidence Interval|Number
789386|NCT00862784|Primary|Progression-Free Survival (PFS)|PFS was defined as the time from date of first dose to the first observation of progression of disease (PD) or death due to any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. PD is ≥20% increase in sum of longest diameter of target lesions and/or unequivocal progression of non-target lesion and/or new lesion. For participants who had no PD or death or had started new therapeutic anticancer treatment, PFS was censored at their last radiographic tumor assessment.|First dose to measured progressive disease or death due to any cause up to 28.1 months|All participants who received any amount of study drug. The number of participants censored was 11.||months||95% Confidence Interval|Median
789387|NCT00862810|Primary|Pain Following HPV Vaccine|"Participants with Faces Pain Scale - Revised (FPS-R) score higher in arm where HPV received compared to arm where concomitant vaccines received.
The Faces Pain Scale Revised is a dimensionless 10 point likert scale used to assess self-reported pain intensity on a scale from 0 (no pain) to 10 (most pain you can imagine). Greater pain scores are indicative of more severe pain."|10 minutes following vaccination|||participants|||Number
789388|NCT00862823|Primary|Maximum Concentration for Tenofovir, Emtricitabine and Efavirenz|The maximum concentration for tenofovir, emtricitabine and efavirenz|17 days|US Food and Drug Administration. Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug ProductsdGeneral Considerations. Rockville, MD: United States Food and Drug Administration Center for Drug Evaluation and Research.||mg/L||Geometric Coefficient of Variation|Geometric Mean
789389|NCT00862823|Primary|Area Under the Concentration Time Curve for Tenofovir, Emtricitabine and Efavirenz|The area under the concentration time curve for tenofovir, emtricitabine and efavirenz|17 days|US Food and Drug Administration. Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug ProductsdGeneral Considerations. Rockville, MD: United States Food and Drug Administration Center for Drug Evaluation and Research.||mg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
789390|NCT00862836|Primary|Description (on the Basis of the Safety Set): Safety and Tolerability by Means of Clinically Significant Laboratory Abnormalities. Number of Participants With Neutropenia Grade 3/4.|Number of participants with neutropenia grade 3/4 (CTCAE grade 3=severe, CTCAE grade 4=life threatening).|From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.|||Participants|||Number
789391|NCT00862836|Primary|Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs). Number of Participants With Mucositis Grade 3.|Number of participants with mucositis grade 3 (CTCAE grade 3=severe pain interfering with oral intake)|From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.|||Participants|||Number
789392|NCT00862836|Primary|Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs). Number of Participants With Palmar-plantar Erythrodysesthesia (PPE) Grade 3/4.|Number of participants with palmar-plantar erythrodysesthesia (PPE) grade 3/4 (CTCAE grade 3=severe skin changes with pain, CTCAE grade 4=life threatening).|From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.|||Participants|||Number
789393|NCT00862836|Primary|Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs). Number of Participants With Dermatologic Skin Reactions Grade 3/4.|Number of participants with dermatologic skin reactions grade 3/4 (CTCAE grade 3= severe, CTCAE grade 4=life threatening)|From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.|||Participants|||Number
789394|NCT00862836|Primary|Description (on the Basis of the Safety Set): Safety and Tolerability by Means of Clinically Significant Laboratory Abnormalities.|Number of patients with elevated liver enzymes grade 3 (CTCAE grade 3=severe, CTCAE grade 4=life threatening).|From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.|||Participants|||Number
789395|NCT00862836|Secondary|Evaluation (for ITT Set): Clinical Activity of Once Daily Oral Vandetanib 100 mg When Added to Standard Therapy (See Above), by Assessment of Overall Survival (OS).|Median overall survival (OS)|From date of registration (Informed Consent Form completed) until the date of death.|||Months||95% Confidence Interval|Median
789396|NCT00862836|Secondary|Evaluation (for ITT Set): Clinical Activity of Once Daily Oral Vandetanib 100 mg When Added to Standard Therapy (See Above), by Assessment of Progression Free Survival (PFS).|Progression Free Survival: Progression is defined using RECIST, as a measurable increase of at least 20% in the sum of longest diameters of target lesions or unequivocal progression of non-target lesions, or the appearance of new lesions, since baseline.|From date of registration (Informed Consent Form completed) until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months.|||Months||95% Confidence Interval|Median
789397|NCT00862836|Primary|Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs).|Number of participants with at least 1 adverse event of grade 3 or higher (CTCAE grade 3=severe, CTCAE grade 4=life threatening/disabling, CTCAE grade 5=death, as defined by National Cancer Institute CTCAE, Version 3)|From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.|||Participants|||Number
789398|NCT00862849|Secondary|Number of Treatment Emergent Adverse Events (TEAEs) Related to Study Drug|The number of TEAEs related to study drug (as determined by the Investigator) are summarized. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|first dose through 7 to 10 days after last dose|Participants who received at least one dose of study drug (insulin lispro, regular human insulin, or recombinant human hyaluronidase [rHuPH20]).||events|||Number
789399|NCT00862849|Secondary|Percentage of Total Glucose Infused|Blood samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); every 5 mins (from 15 to 30 mins); every 15 mins (from 30 to 90 mins); and every 30 mins (from 90 to 240 mins) after each injection. Percentage of total glucose infused from 0 to 4 hours is summarized.|predose up to 240 minutes postdose|Participants who completed all study visits and had evaluable glucose infusion data.||percentage of total glucose infused||Standard Deviation|Mean
789400|NCT00862849|Secondary|Time to Percentage of Total Glucose Infused|Blood samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); every 5 mins (from 15 to 30 mins); every 15 mins (from 30 to 90 mins); every 30 mins (from 90 to 240 mins); and every 60 mins (from 240 to 480 mins) after each injection. Time to 25%, 50%, and 75% of total glucose infused are summarized.|predose up to 480 minutes postdose|Participants who completed all study visits and had evaluable glucose infusion data.||minutes||Standard Deviation|Mean
789401|NCT00862849|Secondary|Peak Serum Insulin Concentration (Cmax)|Cmax was determined as the maximum of all valid serum insulin concentration measurements for each measurement series. Blood samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); every 5 mins (from 15 to 30 mins); every 15 mins (from 30 to 90 mins); every 30 mins (from 90 to 240 mins); and every 60 mins (from 240 to 480 mins) after each injection.|predose up to 480 minutes postdose|Participants who completed all study visits and had evaluable Cmax data.||picomoles per liter (pmol/L)||Standard Deviation|Mean
789402|NCT00862849|Secondary|Time to Early and Late 50% Maximum Serum Insulin Concentration (t[50%Max])|Blood samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); every 5 mins (from 15 to 30 mins); every 15 mins (from 30 to 90 mins); every 30 mins (from 90 to 240 mins); and every 60 mins (from 240 to 480 mins) after each injection.|predose up to 480 minutes postdose|Participants who completed all study visits and had evaluable t(50%max) data.||minutes||Standard Deviation|Mean
789403|NCT00862849|Primary|Intra-participant Variability in Percent of Total Area Under the Plasma Insulin Concentration-Versus-Time Curve Attained by Time T (%AUC[0-T])|Blood samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); and every 5 mins (from 15 to 30 mins) after each injection. The percent coefficient of variation (CV%) was calculated as 100*(standard deviation/mean). The intra-participant CV% was calculated directly from the 2 replications of each treatment. The CV% for percentage of total AUC is reported from 0 to 30 minutes.|predose up to 30 minutes postdose|Participants who completed all study visits and had evaluable %AUC(0-t) data.||percentage of coefficient of variance||Standard Deviation|Mean
789404|NCT00862940|Secondary|Cognitive and Behavioural Outcomes: Mini Mental State Examination (MMSE) Total Score|Adjusted mean change from baseline on cognitive and behavioural scores. MMSE: Brief, structured examination of mental status that assesses orientation, memory, attention, naming, comprehension, and praxis. The range is 0 to 30, with a lower score indicating a worse mental state|Baseline to 1 year|FAS, OC||Scale scores||Standard Error|Least Squares Mean
789405|NCT00862940|Secondary|Cognitive and Behavioural Outcomes: Controlled Oral Word Association Test (COWAT) Total Score|Adjusted mean change from baseline on cognitive and behavioural scores. COWAT: Verbal fluency test. The patient was asked to, during 1 minute, generate as many words as possible beginning with three pre-specified letters. The total score was calculated as the sum of acceptable words generated, with higher scores indicating lower cognitive impairment|Baseline to 1 year|FAS, observed cases (OC)||Scale scores||Standard Error|Least Squares Mean
789406|NCT00862940|Secondary|Changes in Total Hippocampal Volume (HCV)|Estimated mean changes in total HCV|Baseline to 1 year|FAS-MRI||mm^3/year||Standard Deviation|Mean
789407|NCT00862940|Primary|Total Brain Atrophy Rate Estimated Using Brain Boundary Shift Integral (BBSI)|Measures direct changes in total brain volume per visit interval (screening to Week 4, 42, or 52 or from Week 4 to Week 42 or 52)|Baseline to 1 year|FAS-MRI: Full-analysis set for all patients in the all-patients-treated set (APTS) who had at least one valid MRI scan >=6 months after initiation of investigational medicinal product (IMP). The FAS (full analysis set, efficacy set) replaces the intention-to-treat (ITT) concept used in older terminology.||mL/year||Standard Error|Mean
789408|NCT00863057|Other Pre-specified|Methadone Trough Level and Weekly Mean Pain Scores|This was one of the exploratory objectives and was not analyzed as the study was terminated. We do not have any plan to analyze this endpoint.|During the fourth week of each treatment period||||||
789409|NCT00863057|Other Pre-specified|Sensory and Affective Qualities of Pain Measured by the McGill Pain Questionnaire - Short Form (MPQ-SF)|This was one of the exploratory objectives and was not analyzed as the study was terminated. We do not have any plan to analyze this endpoint in the future.|At the fourth treatment week of each treatment period||||||
789410|NCT00863057|Secondary|Incidence of Treatment-emergent Grade 3 to 4 (Safety) and Grade 2 (Tolerability) Toxicities|Grade 2, 3, and 4 events are listed in the AE section.|Throughout study||||||
789411|NCT00863057|Secondary|Maximum Tolerated Dose of Duloxetine and Methadone||During each treatment period|The number below is the highest tolerated daily dose in mg based on n=12 for Methadone and n=10 for Duloxetine.||mg|||Number
789412|NCT00863057|Secondary|Use of Rescue Medication (Acetaminophen)||During each treatment period and the subsequent cross-over (or final study week) period|The analysis was per protocol. Because of a cross-over trial, the # of participants analyzed do not match with the flow chart. Any participant who took the rescue med during the study period (incl. cross-over period) was counted in this analysis. If a participant took the rescue med twice within the same period, the number is counted as one.||participants|||Number
789413|NCT00863057|Secondary|Patient and Clinician Global Impression of Change (PGIC and CGIC) on a 7-point Likert Scale|"The GIC scale is a validated instrument that consists of seven verbal descriptors on a 7-point scale:
Very much improved
Much improved
Minimally improved
No change
Minimally worse
Much worse
Very much worse
Participants were carefully instructed to consider the impact of study treatments on their level of neuropathic pain intensity during the baseline phase of the study."|At the fourth treatment week of each treatment period|The analysis was per protocol. Since this is a cross-over trial, the number of participants analyzed do not match with the ones in the flow chart.||participants|||Number
789414|NCT00863057|Secondary|Emotional Functioning as Measured by the Center for Epidemiologic Studies Depression Scale (CES-D)|The CES-D is a 20-item self-report rating inventory measuring characteristic attitudes and symptoms of depression. Participants were asked to score each item: (0) Rarely, (1) Occasionally, (2) Sometimes, and (3) Most of time. Some items are multiplied by -1 to change direction. The overall CES-D score is simply the sum of 20 items. The highest possible total CES-D score is 48, and the lowest possible score is -12. The total CES-D score is considered missing if more than 4 items are not answered.|At the fourth treatment week of each treatment period|The analysis was per protocol. Since this is a cross-over trial, the number of participants analyzed do not match with the ones in the flow chart.||Scores on a scale||Standard Deviation|Mean
789415|NCT00863057|Secondary|Quality of Life Measured by SF-36 Healthy Survey (SF-36)|This endpoint was not analyzed as there was an issue with a company which provides a software to calculate SF-36. We do not have any plan to analyze this endpoint in the future.|At the fourth treatment week of each treatment period||||||
789416|NCT00863057|Secondary|Pain-related Interference Measured by the Brief Pain Inventory (BPI) Interference Items|"The BPI interference scale measured level of interference with the following seven items:
General activity
Mood
Walking ability
Normal work
Relations with other people
Sleep
Enjoyment of life
Interference scales range from 0=’Does not interfere’ to 10=’Completely interferes’. The overall BPI score is the mean of seven item with the minimum and maximal scores of 0 and 70, respectively."|At the fourth week of each treatment period|The analysis was per protocol. Since this is a cross-over trial, the number of participants analyzed do not match with the ones in the flow chart.||Scores on a scale||Inter-Quartile Range|Median
789417|NCT00863057|Secondary|Mean Nighttime Pain Measure on an 11-point Likert Scale|"Pain was measured on an 11-point Likert numerical rating scale, ranging from 0=``No pain to 10=``Pain as bad as you can imagine.
Participants were given pain diaries at weeks 0, 5, 10, and 15. They started the diary 7 days prior to their clinic visits at weeks 0, 4, 9, 14, and 19. During the 7 days, each morning, they recorded their pain level due to neuropathy by circling the number that best described their neuropathy pain on average during the night time."|Over the fourth treatment week of each treatment period|The analysis was per protocol. Since this is a cross-over trial, the number of participants analyzed do not match with the ones in the flow chart.||Scores on a scale||Standard Error|Mean
789418|NCT00863057|Secondary|Number of Participants With 50% or More Improvement in Mean Pain Score on an 11-point Likert Scale|"Pain was measured on an 11-point Likert numerical rating scale, ranging from 0=``No pain to 10=``Pain as bad as you can imagine at baseline and over the fourth treatment week of each treatment period.
The % of improvement was calculated as (x-y)/x,where x was the MPI score at baseline, and y was the MPI score at the end of each treatment stage."|At Baseline and over the fourth treatment week of each treatment period|The analysis was per protocol. Since this is a cross-over trial, the number of participants analyzed do not match with the ones in the flow chart.||participants|||Number
789419|NCT00863057|Secondary|Number of Participants With 30% or More Improvement in Mean Pain Score on an 11-point Likert Scale|"Pain was measured on an 11-point Likert numerical rating scale, ranging from 0=``No pain to 10=``Pain as bad as you can imagine at baseline and over the fourth treatment week of each treatment period.
The % of improvement was calculated as (x-y)/x,where x was the MPI score at baseline, and y was the MPI score at the end of each treatment stage."|At Baseline and over the fourth treatment week of each treatment period|The analysis was per protocol. Since this is a cross-over trial, the number of participants analyzed do not match with the ones in the flow chart.||participants|||Number
789420|NCT00863057|Primary|Weekly Mean Pain Score Derived From Self-reported Average Daily Pain Intensity on an 11-point Likert Scale|"Pain was measured on an 11-point Likert numerical rating scale, ranging from 0=``No pain to 10=``Pain as bad as you can imagine.
Participants were given pain diaries at weeks 0, 5, 10, and 15. They started the diary 7 days prior to their clinic visits at weeks 0, 4, 9, 14, and 19. During the 7 days, each morning, they recorded their pain level due to neuropathy by circling the number that best described their neuropathy pain on average over the past 24 hours."|During the fourth treatment week of each treatment period|The analysis was per protocol. Since this is a cross-over trial, the number of participants analyzed do not match with the ones in the flow chart.||Scores on a scale||Standard Deviation|Mean
789444|NCT00864851|Secondary|Change From Baseline to Month 12 in Maximal Oxygen Consumption (VO2 Max) at Peak Exercise|Exercise tolerance as measured by VO2 max at peak exercise using the standard exponential exercise protocol (STEEP).|Baseline, Month 12 (Week 53)|Intent to Treat (ITT) Population: All randomized patients who received at least 1 complete or partial dose of Replagal.||mL/min/kg||Standard Deviation|Mean
789421|NCT00863109|Secondary|Percentage of Participants Who Were Compliant With Treatment According To Medication Count (Subset Analysis)|Compliance was calculated as the amount of dispensed medication minus the amount of medication returned by participants divided by amount of dispensed medication.|From Baseline Visit to Final Visit (up to 72 weeks)|All Evaluable Participants; participants who had met the evaluation and eligibility criteria and were included in the study. Analysis Population included 53 participants who completed 48 weeks of treatment and 77 participants who did not complete 48 weeks of treatment (early end).||percentage of participants|||Number
789422|NCT00863109|Secondary|MCID in CLDQ-HCV Scores|The CLDQ-HCV is a disease-specific questionnaire measuring HRQL that contains 29 items divided into 4 domains: emotional function (9 items), worry (6 items), systemic symptoms (8 items) and activity/energy (6 items). All items refer to the previous 2 weeks and are rated on a 7 point Likert scale, with 1 corresponding to the maximum frequency (“all of the time”) and 7 to the minimum (“none of the time”). Domain scores are the means of the items contained. A summary score is calculated by the mean of all domain scores (CLDQ-HCV Global). Higher scores indicate better health-related quality of life. MCID was defined as the difference in questionnaire scores between baseline and final visits for those participants who had stated that their health status had changed at the end of the study (improved in one category of health status perceived by themselves). The MCID was calculated for each domain of the CLDQ-HCV and for the CLDQ-HCV summary score.|From Baseline Visit to Final Visit (up to 72 weeks)|All Evaluable Participants (participants who had met the evaluation and eligibility criteria and were included in the study) who had improved in one category of health status as perceived by themselves.||score on a scale||Standard Deviation|Mean
789423|NCT00863109|Secondary|Minimal Clinically Important Difference (MCID) in SF-36 Scores|SF-36 is a 36-item questionnaire measuring HRQL covering 2 summary measures, PCS and MCS. The SF-36 consists of 8 subscales. PCS is represented by physical function, role limitations-physical, pain, and general health perception. MCS is represented by vitality, social function, role limitations-emotional, and mental health. Subscale items are summed and scaled from 0-100 to give subscale scores; 0= worst HRQL, 100=best HRQL. PCS and MCS summary scores are constructed as T-scores (mean =50, standard deviation=10) with no minimum or maximum score; higher scores indicate better health status. MCID was defined as the difference in questionnaire scores between baseline and final visits for those participants who had stated that their health status had changed at the end of the study (improved in one category of health status as perceived by themselves). The MCID was calculated for each subscale of the SF-36 and for PCS and MCS.|From Baseline Visit to Final Visit (up to 72 weeks)|All Evaluable Participants (participants who had met the evaluation and eligibility criteria and were included in the study) who had improved in one category of health status as perceived by themselves.||score on a scale||Standard Deviation|Mean
789424|NCT00863109|Secondary|Change From Baseline to Week 72 (WK72) in CLDQ-HCV Scores Among Participants Who Completed Treatment and Participants Who Had Early End of Treatment (Subset Analysis)|The CLDQ-HCV is a disease-specific questionnaire measuring quality of life that contains 29 items divided into 4 domains: emotional function (9 items), worry (6 items), systemic symptoms (8 items) and activity/energy (6 items). All items refer to the previous 2 weeks and are rated on a 7 point Likert scale, with 1 corresponding to the maximum frequency (“all of the time”) and 7 to the minimum (“none of the time”). Domain scores are the means of the items contained. A summary score is calculated by the mean of all domain scores (CLDQ-HCV Global). Higher scores indicate better health-related quality of life.|Baseline, Week 72|All Evaluable Participants (participants who had met the evaluation and eligibility criteria and were included in the study) who had CLDQ-HCV data available at baseline and Week 72. Analysis Population included 38 participants who completed 48 weeks of treatment and 8 participants who did not complete 48 weeks of treatment (early end).||score on a scale||Standard Deviation|Mean
789425|NCT00863109|Secondary|Change From Baseline to Week 72 (WK72) in SF-36 Scores Among Participants Who Completed Treatment and Participants Who Had Early End of Treatment (Subset Analysis)|SF-36 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: physical component summary (PCS) and mental component summary (MCS). The SF-36 consists of 8 subscales. The PCS is represented by 4 subscales: physical function, role limitations due to physical problems, pain, and general health perception. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; zero= worst HRQL, 100=best HRQL. PCS and MCS scores are constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score; higher scores indicate better health status.|Baseline, Week 72|All Evaluable Participants (participants who had met the evaluation and eligibility criteria and were included in the study) who had SF-36 data available at baseline and Week 72. Analysis Population included 38 participants who completed 48 weeks of treatment and 8 participants who did not complete 48 weeks of treatment (early end).||score on a scale||Standard Deviation|Mean
789426|NCT00863109|Primary|Change From Baseline (BL) to Week 72 (WK72) in Chronic Liver Disease Questionnaire-Hepatitis C Virus (CLDQ-HCV)|The CLDQ-HCV is a disease-specific questionnaire measuring HRQL that contains 29 items divided into 4 domains: emotional function (9 items), worry (6 items), systemic symptoms (8 items) and activity/energy (6 items). All items refer to the previous 2 weeks and are rated on a 7 point Likert scale, with 1 corresponding to the maximum frequency (“all of the time”) and 7 to the minimum (“none of the time”). Domain scores are the means of the items contained. A summary score is calculated by the mean of all domain scores (CLDQ-HCV Global). Higher scores indicate better health-related quality of life.|Baseline, Week 72|All Evaluable Participants (participants who had met the evaluation and eligibility criteria and were included in the study) who had CLDQ-HCV data available at baseline and Week 72.||score on a scale||Standard Deviation|Mean
789445|NCT00864851|Primary|Change From Baseline to Month 12 in Left Ventricular Mass Indexed to Height (LVMI)|Left ventricular mass (LVM) was measured through echocardiography.|Baseline, Month 12 (Week 53)|Intent to Treat (ITT) Population: All randomized patients who received at least 1 complete or partial dose of Replagal.||g/m^2.7||Standard Deviation|Mean
789446|NCT00864916|Primary|Flow-mediated Dilation of the Brachial Artery|Flow-mediated dilation (% dilation of the brachial artery) at week 48|Measured at Week 48|Numbers of participants who completed the week 48 visit procedures||percent dilation of the brachial artery||Standard Deviation|Mean
789427|NCT00863109|Primary|Change From Baseline (BL) to Week 72 (WK72) in 36-Item Short-Form Health Survey (SF-36) Scores|SF-36 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: physical component summary (PCS) and mental component summary (MCS). The SF-36 consists of 8 subscales. The PCS is represented by 4 subscales: physical function, role limitations due to physical problems, pain, and general health perception. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; zero= worst HRQL, 100=best HRQL. PCS and MCS scores are constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score; higher scores indicate better health status.|Baseline, Week 72|All Evaluable Participants (participants who had met the evaluation and eligibility criteria and were included in the study) who had SF-36 data available at baseline and Week 72.||score on a scale||Standard Deviation|Mean
789428|NCT00864682|Secondary|Satisfaction With Anesthetic Technique|Were you satisfied with the anesthetic technique? Yes/No|Prior to discharge. One time assessment|||Participants|||Number
789429|NCT00864682|Secondary|Complete Alleviation of Injection Pain|Total subjects within the arm versus those subjects who had no pain with injection (VPS=0)|Immediately after injection of study drug. One time assessment|||Participants|||Number
789430|NCT00864682|Primary|Verbal Pain Score|11 point verbal pain score (VPS) 0=no pain; 10=worst imaginable pain|Immediately after injection of study drug. One time assessment.|||Units on a scale||Inter-Quartile Range|Median
789431|NCT00864708|Primary|Kinematic Gait Measures|assessment of the lower limb kinematics during ambulation at chosen speed.|Day 1 and at 3 months, following treatment|||percentage of change Day 1 to 3 months|||Number
789432|NCT00864708|Secondary|Manual Muscle Testing (MMT)|This is a measure of strength of the various muscle groups of the lower limb. Each is graded on a 0 to 5 scale; the final score is the summed total of the lower limb muscle groups tested. (score range of summed muscles is 0-50, with 50 being the maximum highest score)|Day 1 and at 3 months, following treatment|||units on a scale|||Number
789433|NCT00864708|Secondary|Stroke Impact Scale (SIS)|The SIS is a measure of Quality of Life/Life Role Participation following stroke. Each item in a domain is scored between 0 and 5. A higher score indicates better performance (range 0-295).|Day 1 and at 3 months, following treatment|||units on a scale|||Number
789434|NCT00864708|Secondary|Ashworth Scale|The Ashworth Scale is a measure of muscle spasticity; muscle groups are graded from 0 (no spasticity) to 4 (greatest spasticity/contracture). The lower limb muscle groups are summed for a total lower limb Ashworth score. A lower score indicates better performance. (range is 0-40)|Day 1 and at 3 months, following treatment|||units on a scale|||Number
789435|NCT00864708|Secondary|Fugl-Meyer Lower Extremity Score|Fugl-Meyer Lower Extremity Score (FMLE) is an itemized measure of lower extremity coordination following stroke. Scores for the FMLE range from 0 (most impaired) to 34 (normal).|Day 1 and at 3 months, following treatment|||units on a scale|||Number
789436|NCT00864708|Primary|Walking Endurance (6MWT)|The Six Minute Walk Test (6MWT) is a measure of the distance measured in feet ambulated by the participant during six minutes. A further distance walked in 6 minutes indicates improvement on the measure.|Day 1 and at 3 months, following treatment|||feet|||Number
789437|NCT00864851|Secondary|Safety Evaluation|Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.|56 Weeks|Intent to Treat (ITT) Population: All randomized patients who received at least 1 complete or partial dose of Replagal. Analyses were performed on the ITT population because it was identical to the safety population.||participants|||Number
789438|NCT00864851|Secondary|Change From Baseline to Month 12 in Urinary Albumin/Creatinine (A/Cr) Ratio||Baseline, Month 12 (Week 53)|Intent to Treat (ITT) Population: All randomized patients who received at least 1 complete or partial dose of Replagal.||mg/g||Standard Deviation|Mean
789439|NCT00864851|Secondary|Change From Baseline to Month 12 in Estimated Glomerular Filtration Rate (eGFR)|Renal function was assessed by an evaluation of change from baseline to Month 12 in eGFR as calculated using the Modification of Diet for Renal Disease (MDRD) equation.|Baseline, Month 12 (Week 53)|Intent to Treat (ITT) Population: All randomized patients who received at least 1 complete or partial dose of Replagal.||mL/min/1.73m^2||Standard Deviation|Mean
789440|NCT00864851|Secondary|Change From Baseline to Month 12 in Plasma Globotriaosylceramide (GB3)||Baseline, Month 12 (Week 53)|Intent to Treat (ITT) Population: All randomized patients who received at least 1 complete or partial dose of Replagal.||nmol/ml||Standard Deviation|Mean
789441|NCT00864851|Secondary|Change From Baseline to Month 12 in New York Heart Association (NYHA) Functional Class|"The NYHA functional classification system relates symptoms to everyday activities and the patient's quality of life.
NYHA Classification - The Stages of Heart Failure:
Class I (Mild): No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea (shortness of breath).
Class II (Mild): Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea.
Class III (Moderate): Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea.
Class IV (Severe): Unable to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. If any physical activity is undertaken, discomfort is increased."|Baseline, Month 12 (Week 53)|Intent to Treat (ITT) Population: All randomized patients who received at least 1 complete or partial dose of Replagal.||participants|||Number
789442|NCT00864851|Secondary|Change From Baseline to Month 12 in the Minnesota Living With Heart Failure Questionnaire (MLHF-Q) Summary Score|Quality of life (QoL) was evaluated using the MLHF-Q, version 2. The questionnaire is designed to assess the degree to which heart failure symptoms affect a patient's daily life. The summary score ranges from 0 to 105, with a score of 105 representing the highest adverse impact on a patient's QoL.|Baseline, Month 12 (Week 53)|Intent to Treat (ITT) Population: All randomized patients who received at least 1 complete or partial dose of Replagal.||scores on a scale||Standard Deviation|Mean
789443|NCT00864851|Secondary|Change From Baseline to Month 12 in Distance Walked in 6-Minute Walk Test (6MWT)|Exercise tolerance using the 6MWT was measured as the total distance walked in 6 minutes.|Baseline, Month 12 (Week 53)|Intent to Treat (ITT) Population: All randomized patients who received at least 1 complete or partial dose of Replagal.||m||Standard Deviation|Mean
789447|NCT00865020|Secondary|Change in the Mean Diastolic Sitting Blood Pressure (msDBP) as Measured at All Study Visits During the Double-blind Treatment Period and During the Treatment Withdrawal Period|"Blood Pressure was measured in the office after the patient was sitting for 5 minutes. The average of 3 readings 1-2 min. apart were used in the analysis.
The change in the double-blind period was calculated from the end of active treatment at week 12 to the Baseline (Randomization) using Analysis of Covariance with treatment and region as factors and baseline msDBP as a covariate.
The change in the treatment interruption period was calculated from day 7 of the withdrawal period at week 13 to the end of the active treatment using Analysis of Variance with treatment and region as factors."|Baseline, 12 weeks, 13 weeks|Full Analysis set consisting of all participants randomized to treatment. n1=participants with measurements at baseline and end of the active treatment period for the Double-blind Period. n2=participants with measurements at the end of the active treatment period and end of the treatment withdrawal period for the Treatment Interruption Period.||mmHg||Standard Error|Least Squares Mean
789448|NCT00865020|Secondary|Change in the Mean Sitting Systolic Blood Pressure (msSBP) as Measured at All Study Visits During the Double-blind Treatment Period and During the Treatment Withdrawal Period|"Blood Pressure was measured in the office after the patient was sitting for 5 minutes. The average of 3 readings 1-2 minutes apart were used in the analysis.
The change in the double-blind period was calculated from the end of active treatment at week 12 to the Baseline (Randomization) using Analysis of Covariance with treatment and region as factors and baseline msSBP as a covariate.
The change in the treatment interruption period was calculated from day 7 of the withdrawal period at week 13 to the end of the active treatment using Analysis of Variance with treatment and region as factors."|Baseline, 12 weeks, 13 weeks|Full Analysis set consisting of all participants randomized to treatment. n1=participants with measurements at baseline and end of the active treatment period for the Double-blind Period. n2=participants with measurements at the end of the active treatment period and end of the treatment withdrawal period for the Treatment Interruption Period.||mmHg||Standard Error|Least Squares Mean
789449|NCT00865020|Secondary|Change in 24-hr Mean Ambulatory Systolic Blood Pressure (MASBP) and Mean Ambulatory Diastolic Blood Pressure (MADBP) From Baseline to Day 7 of the Withdrawal Period|An Ambulatory Blood Pressure Monitor measured a participants's blood pressure over a 24 hour period using an automated validated monitoring device at Baseline (at Randomization) and at week 13 (day 7 of the withdrawal period). The 4 Hour MASBP and MADBP was calculated by taking the mean of all Ambulatory Blood Pressure readings during the 24 hour period. The difference of the 24 hour measurements from baseline to day 7 of the withdrawal period were calculated using a two way analysis of variance with treatment and region as factors and baseline as a covariate.|Baseline, 13 weeks|Full Analysis Set consisting of all participants randomized to treatment with measurements at baseline and day 7 of the withdrawal period.||mmHg||Standard Error|Least Squares Mean
789450|NCT00865020|Secondary|Change in 24 Hour (24-hr) Mean Ambulatory Diastolic Blood Pressure (MADBP) From the End of the Active Treatment Period to Day 7 of the Withdrawal Period|An Ambulatory Blood Pressure Monitor measured a participants's blood pressure over a 24 hour period using an automated validated monitoring device at week 12 (end of the active treatment) and at week 13 (end of the day 7 withdrawal period). The 24 Hour MADBP was calculated by taking the mean of all Ambulatory Diastolic Blood Pressure readings for the 24 hour period. The difference of the 24 hour MADBP from the end of the active treatment to Day 7 of the withdrawal period was calculated using a two way analysis of variance with treatment and region as factors.|12 weeks, 13 weeks|ABPM Completer Set consisting of all participants in the Full Analysis set who had ABPM measurements at the end of the active treatment period and Day 7 of the treatment withdrawal period.||mmHg||Standard Error|Least Squares Mean
789451|NCT00865020|Primary|Change in 24 Hour (24-Hr) Mean Ambulatory Systolic Blood Pressure (MASBP) From the End of the Active Treatment Period to Day 7 of the Withdrawal Period|An Ambulatory Blood Pressure Monitor measured a participants's blood pressure over a 24 hour period using an automated validated monitoring device at week 12 (end of the active treatment) and at week 13 (end of the day 7 withdrawal period). The 24 Hour MASBP was calculated by taking the mean of all Ambulatory Systolic Blood Pressure readings for the 24 hour period. The difference of the 24 hour MASBP from the end of the active treatment to Day 7 of the treatment withdrawal period was calculated using a two way analysis of variance with treatment and region as factors.|12 weeks, 13 weeks|ABPM Completer Set consisting of all participants in the Full Analysis set who had ABPM measurements at the end of the active treatment period and Day 7 of the treatment withdrawal period.||mmHg||Standard Error|Least Squares Mean
789452|NCT00865046|Primary|Pain (WOMAC)|"The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) consists of 24 items divided into 3 subscales:
Pain (5 items), score range 0-20 Stiffness (2 items): score range 0-8 Physical Function (17 items): score range 0-68 Total score ranges from 0 (best possible outcome) to 96 (worst possible outcome)"|9 months following baseline|||units on a scale||Standard Error|Mean
789453|NCT00865098|Secondary|Safety - Number of Patients Experiencing Any Grade 3 or 4 Infusion Related Reaction|Infusion related reactions were considered as adverse events of special interest and were evaluated in a special AE category composed of specific MedDRA preferred terms. Severity was assessed according to criteria defined in the NCI-CTCAE, Version 3.0, where grade 1 is mild, grade 2 moderate, grade 3 severe, and grade 4 lifethreatening or disabling.|time from first dose up to 60 days after last dose of study treatment, ≤18 weeks|ITT/Safety population, i.e. all subjects who have received at least one dose of the study treatment||participants|||Number
789454|NCT00865098|Secondary|Safety - Number of Patients Experiencing Any Grade 3 or 4 Skin Reaction|Skin reactions were considered as adverse events of special interest and were evaluated in a special AE category composed of specific MedDRA preferred terms. Severity was assessed according to criteria defined in the NCI-CTCAE, Version 3.0, where grade 1 is mild, grade 2 moderate, grade 3 severe, and grade 4 lifethreatening or disabling.|time from first dose up to 60 days after last dose of study treatment, ≤18 weeks|ITT/Safety population, i.e. all subjects who have received at least one dose of the study treatment||participants|||Number
789499|NCT00865904|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Day 28|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.|Baseline, Day 28|Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study drug. Number of participants analyzed signifies participants evaluable for this outcome.||liters||95% Confidence Interval|Least Squares Mean
789455|NCT00865098|Secondary|Safety - Number of Patients Experiencing Any Grade 4 Adverse Event|Severity was assessed according to the toxicity criteria defined in the National Cancer Institute - Common Terminology Criteria for Adverse Event (NCI-CTCAE), Version 3.0, where grade 1 denoted mild, grade 2 moderate, grade 3 severe, and grade 4 lifethreatening or disabling. In the case of adverse events not contained within the NCI-CTCAE, the investigator was responsible for assessing the severity of the AE (grades 1 to 4) based on the jeopardy to the subject’s health and well-being, and the ability of the subject to function during the event.|time from first dose up to 60 days after last dose of study treatment, ≤18 weeks|ITT/Safety population, i.e. all subjects who have received at least one dose of the study treatment||participants|||Number
789456|NCT00865098|Secondary|Safety - Number of Patients Experiencing Any Adverse Event|Please refer to Adverse Events section for further details|time from first dose up to 60 days after last dose of study treatment, ≤18 weeks|ITT/Safety population, i.e. all subjects who have received at least one dose of the study treatment||participants|||Number
789457|NCT00865098|Secondary|Best Response Rate|Number of subjects experiencing a Complete Response (complete disappearance of measurable and evaluable disease without new lesions) or Partial Response (>=50% decrease of the sum of the product diameters of measurable disease, evaluable disease not worsening or progressing, no new lesions) at 8 weeks post radiotherapy (confirmed by repeat assessment at week 12) based on imaging according to modified World Health Organisation criteria as assessed independently by the Efficacy and Safety Evaluation Committee, divided by the number of subjects in the ITT/safety population|best response was determined at week 8 post radiotherapy, for subjects with complete or partial response a confirmation in week 12 post radiotherapy was required|ITT/Safety population, i.e. all subjects who have received at least one dose of the study treatment||percentage of participants||95% Confidence Interval|Number
789458|NCT00865098|Primary|Completion Rate|Number of subjects who complete ≥70% of Cetuximab planned dose administration in terms of relative dose intensity of Cetuximab and full dose of RT ≤2 weeks over planned schedule in terms of RT duration ≤8 weeks, divided by the the number of subjects in the ITT/Safety population|time from first administration of cetuximab to last administration of cetuximab or RT (whichever is later), ≤ 9 weeks|ITT/Safety population, i.e. all subjects who have received at least one dose of the study treatment||percentage of participants||95% Confidence Interval|Number
789459|NCT00865124|Secondary|Change in Renal Plasma Flow|Renal vasculature was assessed by examining renal plasma flow, or para-aminohippurate (PAH) clearance, basally and in response to acute administration (3 nanograms/kg/min for 60 min) of the vasoactive agent, Angiotensin II.|Baseline and six months|All participants with data available for this outcome measure at the given time-point.||mL/min/1.73m^2||Standard Deviation|Mean
789460|NCT00865124|Secondary|Mitral Annulus Velocities on Tissue Doppler (Delta E/e’ Ratio), a Measure of Diastolic Function (With Angiotensin II)|Diastolic function was assessed via tissue doppler imaging (TDI) by echocardiography to determine left ventricular diastolic function before and after 6 months of treatment; and in response to acute administration (3 nanograms/kg/min for 60 min) of the vasoactive agent, Angiotensin II.|Baseline and six months|All participants with data available for this outcome measure at the given time-point.||ratio||Standard Deviation|Mean
789461|NCT00865124|Secondary|Change in Mitral Annulus Velocities on Tissue Doppler (Delta E/e’ Ratio), a Measure of Diastolic Function|Diastolic function was assessed via tissue doppler imaging (TDI) by echocardiography to determine left ventricular diastolic function before and after 6 months of treatment.|Baseline and six months|All participants with data available for this outcome measure.||ratio||Standard Deviation|Mean
789462|NCT00865124|Primary|Change in Coronary Flow Reserve From Baseline to 6 Months|Coronary flow reserve (CFR), or myocardial perfusion reserve, was assessed via cardiac positron emission tomography (PET). CFR is the ratio of adenosine-stimulated blood flow through myocardium to resting blood flow through myocardium. An improvement in coronary flow reserve is beneficial.|Baseline and six months|All participants with data available for this outcome measure.||ratio||Standard Deviation|Mean
789463|NCT00865189|Secondary|Percentage of Participants With Surgery|The surgery involving a radical rectal excision using the TME technique.|Arm A: approximately 28-31 weeks after initiation of treatment; Arm B: approximately 13-15 weeks after initiation of treatment|ITT population||percentage of participants|||Number
789464|NCT00865189|Secondary|Number of Cycles of Radiotherapy||Arm A: Week 16 to Week 23; Arm B: Week 1 to Week 7|ITT population||cycles||Standard Deviation|Mean
789465|NCT00865189|Secondary|Number of Cycles of Chemotherapy||Arm A: Week 16 to Week 23; Arm B: Week 1 to Week 7|ITT population||cycles||Standard Deviation|Mean
789466|NCT00865189|Secondary|Number of Cycles of Induction Chemotherapy||6 cycles (12 weeks; cycle length = 14 days)|ITT population. Only Arm A participants received induction treatment.||cycles||Standard Deviation|Mean
789467|NCT00865189|Secondary|Overall Survival|The overall survival was defined as the time from the first treatment intake to death from any cause.|From the first treatment administration to the date of death (up to approximately 6 years)|ITT population||months||95% Confidence Interval|Median
789468|NCT00865189|Secondary|Percentage of Participants Who Died||Baseline up to approximately 6 years|ITT population||percentage of participants|||Number
789469|NCT00865189|Secondary|Disease-Free Survival (DFS)|The DFS was defined as the time from the first treatment intake to disease recurrence assessed (second primary cancer, local or distant recurrence, distant metastases) or death from any cause. The DFS was analyzed using Kaplan-Meier method.|From first time of the treatment administration to the date of second cancer, local or regional recurrence, distant metastasis or death from any cause (up to approximately 6 years)|ITT population||months||95% Confidence Interval|Median
789470|NCT00865189|Secondary|Percentage of Participants With Second Cancer, Local or Regional Recurrence, Distant Metastasis, or Death||Baseline up to approximately 6 years|ITT population||percentage of participants|||Number
789471|NCT00865189|Secondary|Percentage of Participants With Local and Distant Recurrences|The percentage of participants with a recurrence was described by type of recurrence (local and distant recurrence).|After surgery (Arm A: approximately 28-31 weeks after initiation of treatment; Arm B: approximately 13-15 weeks after initiation of treatment)|ITT population||percentage of participants||95% Confidence Interval|Number
789707|NCT00860262|Secondary|Change From Baseline in Trough Seated Systolic Blood Pressure at Week 1|Overall mean reduction from a common mean baseline in SBP|baseline and week 1|Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement.||mmHg (millimeters of mercury)||Standard Error|Least Squares Mean
789472|NCT00865189|Secondary|Percentage of Participants With Tumor Down-Staging (ypT0-pT2)|A participant with a downstaging was defined as a participant with T3 (T describes the size of the original [primary] tumor) at inclusion and T2 or T1 or T0 after surgery, or with N+ (N describes lymph nodes involvement) at inclusion and N- after surgery and if T is equal at inclusion and after surgery. The clinical tumor-node-metastasis (cTNM) classification was used at inclusion and the pathological staging tumor and nodes (ypTN) classification after surgery. Reported is the percentage of participants with tumor downstaging of the surgical specimen according to the local review and centralized review.|After surgery (Arm A: approximately 28-31 weeks after initiation of treatment; Arm B: approximately 13-15 weeks after initiation of treatment)|ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome. “n” = participants who were evaluable for specified category.||percentage of participants||95% Confidence Interval|Number
789473|NCT00865189|Primary|Percentage of Participants With Tumor Sterilization Defined by ypT0-N0|Tumor sterilization was defined as the absence of residual tumor cells in the resected specimen including lymph nodes (ypT0-N0). The rate of sterilization of the tumoral specimen was assessed after surgery on the surgical specimen by local review. Analyses were performed for participants who have been operated as defined by the protocol (within the study and TME technique) and for all participants who have been operated. Reported is the percentage of participants with tumor sterilization.|After surgery (Arm A: approximately 28-31 weeks after initiation of treatment; Arm B: approximately 13-15 weeks after initiation of treatment)|ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome.||percentage of participants||95% Confidence Interval|Number
789474|NCT00865202|Secondary|Length of Post-operative ICU and Hospital Stay||length of post-op hospital stay|||days||Standard Deviation|Mean
789475|NCT00865202|Secondary|Level of Post-operative Melatonin||Blood draw on post-operative day number two|||pg/mL||Standard Deviation|Mean
789476|NCT00865202|Secondary|Level of Post-operative Serum Tryptophan||post-operative day number two blood draw|||umol/L||Standard Deviation|Mean
789477|NCT00865202|Secondary|Incidence of Post-operative Delirium|"The incidence and/or duration of excitatory (hyperactive and mixed) post-operative delirium, diagnosed by the Confusion Assessment Method-ICU (CAM-ICU) with the Richmond Agitation Sedation Score (RASS), will be reduced with enteral L-tryptophan supplementation (1 gm TID for the first 3 post-op days), compared to placebo, in older patients (≥ 60 years) undergoing operations requiring ICU admission.
The incidence and/or duration of all types of post-operative delirium, diagnosed by the CAM-ICU with the RASS, will be reduced with enteral L-tryptophan supplementation (1 gm TID for the first 3 post-op days), compared to placebo, in older patients (≥ 60 years) undergoing operations requiring ICU admission."|post-operatively daily in ICU until discharged from ICU|||percentage of patient escitatorydelirium|||Number
789478|NCT00865202|Primary|Duration of Post-operative Delirium||post-operatively daily in ICU until discharged from ICU|||days||Standard Deviation|Mean
789479|NCT00865306|Other Pre-specified|Number of Responders Using Clinical Global Impression-Anxiety Improvement at 1-Year Follow-Up|"Clinicians rated improvement on anxiety since baseline using the Clinical Global Impression-Anxiety Improvement scale (Best 1, Worst 7), with children considered responders if they were rated 1, very much improved or 2, much improved. Note that rates for controls are for controls who were subsequently treated with CBT (after completing the wait-list control condition)."|1-Year Follow-Up|"We tabulated the number of children that were much or very much improved on anxiety since baseline. Note that the controls who were followed up at one-year were those who subsequently received CBT (after participating in the wait-list condition). Therefore the No intervention (wait-list controls) followed up here had actually received CBT."||Participants|||Number
789480|NCT00865306|Other Pre-specified|Number of Children Free of Anxiety Disorders|Number of children free of anxiety disorders, as assessed by clinicians blind to treatment condition.|Post-Treatment (6-months from baseline)|||Participants|||Number
789481|NCT00865306|Primary|Number of Responders Based on Clinician Global Impression-Anxiety Improvement|"Clinicians blind to treatment assignment rated the child's global improvement on anxiety, using the Clinician Global Impression-Anxiety Improvement scale (CGI-Anxiety, best value 1, worst value 7). Responders were considered those with very much or much improvement (CGI-Anxiety scores of 1 or 2)"|Post-Treatment (6-months from baseline)|||Participants|||Number
789482|NCT00865345|Secondary|Device Related Moderate or Device Related Severe Adverse Events|Device related moderate adverse event: low level of inconvenience or concern to the subject and may interfere with daily activities but is usually improved by simple therapeutic remedy Device related severe adverse event: interrupts a subject’s daily activity and typically requires intervening treatment. Note: device related determination is made by the site that there is a reasonable possibility that the adverse event may have been caused by the device.|days one through six of sensor wear|||events|||Number
789483|NCT00865345|Primary|Glucose Sensor Accuracy When Compared to Laboratory Standard (YSI-Yellow Springs Instruments)|The primary accuracy parameter (primary effectiveness endpoint) was the comparative readings of paired sensor and YSI glucose readings, measured on days 1 through 6. Accuracy is defined as within 20% agreement between YSI and paired sensor (within 20 mg/dL if YSI <80 mg/dL). Accuracy ranges from 0 - 100, with higher number suggests better accuracy.|Days one through six of sensor use|61 subjects of 63 enrolled subjects (a total of 4971 paired YSI and sensor readings) completed participation in the inpatient frequent blood sampling procedure.||paired YSI/sensor glucose values|Participants|95% Confidence Interval|Number
789484|NCT00865514|Secondary|Inhibition of Tyrosine and Individual's Haplotype|Given the infusion of the above amino acids and DCA administration the inhibition of tyrosine will be measured in the KRT haplotype and non KRT haplotype.|one week|No statistical analysis. The data was incomplete and was not analyzed.|||||
789485|NCT00865514|Primary|The Interaction of DCA and/or Tyrosine Breakdown Products and Maleylacetoacetate Isomerase (MAAI) in Vivo.|"Subjects are administered an infusion of the amino acids leucine and tyrosine. The next day they start a five day course of dichloroacetate(DCA). At the end of five days they receive another infusion of tyrosine and leucine.
The pharmacokinetics of DCA is calculated following the second infusion."|One week|No statistical analysis. The data was incomplete and was not analyzed.|||||
789703|NCT00860262|Secondary|Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 2|Overall mean reduction from a common mean baseline in DBP|baseline and week 2|Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement.||mmHg (millimeters of mercury)||Standard Error|Least Squares Mean
789486|NCT00865709|Secondary|Duration of Response|Duration of Response was defined as the time from date of first response (Complete Response (CR) or Partial Response (PR)) to the date when Progressive Disease (PD) was first documented or to the date of death, whichever occurred first according to Response Evaluation Criteria in Solid Tumors (RECIST). Subjects still having CR or PR and alive at the time of analysis were censored at their last date of tumor evaluation. CR was defined as disappearance of tumor lesions, PR as a decrease of at least 30% and PD as an increase of at least 20% in the sum of tumor lesions sizes.|From randomization of the first subject until 23 months later, assessed every 8 weeks|Duration of response was the time from the first documented CR or PR until the first documented PD or death (if before progression). Only responders (CR or PR) were included in the analysis||months||95% Confidence Interval|Number
789487|NCT00865709|Secondary|Overall Response|Overall response of a subject was defined as the best tumor response (Complete Response (CR) or Partial Response (PR)) observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR was defined as disappearance of tumor lesions, PR was defined as a decrease of at least 30% in the sum of tumor lesion sizes.|From randomization of the first subject until 23 months later, assessed every 8 weeks.|The test was conducted using the intent-to-treat (ITT) population (all subjects who were randomized).||participants|||Number
789488|NCT00865709|Secondary|Time to Progression (TTP)|Time to progression (TTP) was defined as the time from date of randomization to disease progression. Subjects without progression at the time of analysis were censored at their last date of tumor evaluation. Disease progression was defined as an increase of at least 20% in the sum of tumor lesions sizes.|From randomization of the first subject until 23 months later, assessed every 8 weeks.|The test was conducted using the intent-to-treat (ITT) population (all subjects who were randomized).||Months||95% Confidence Interval|Median
789489|NCT00865709|Secondary|Overall Survival (OS)|Overall Survival (OS) was defined as the time from date of randomization to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.|From randomization of the first subject until 33 months later.|||days||95% Confidence Interval|Median
789490|NCT00865709|Primary|Progression-Free Survival (PFS)|Progression-free Survival (PFS) was defined as the time from date of randomization to disease progression or death due to any cause, whichever occurred first. Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation. Disease progression was defined as an increase of at least 20% in the sum of tumor lesions sizes.|From randomization of the first subject until 23 months later, assessed every 8 weeks.|The test was conducted using the intent-to-treat (ITT) population (all subjects who were randomized).||Months||95% Confidence Interval|Median
789491|NCT00865904|Secondary|Area Under the Concentration Versus Time Curve From Time 0 to 24 Hours (AUC0-24) of VX-809|Only participants who received VX-809 were analyzed for this outcome measure.|Day 1 (pre dose, 0.75, 1.5, 3, 4, 6, 9, 12, and 24 hours post-dose), Day 28 (pre dose, 0.75, 1.5, 3, 4, 6, 9, 12, and 24 hours post dose)|FAS. Here, n = participants evaluable for specified category for each arm, respectively.||hour*nanogram per milliliter (hr*ng/mL)||Standard Deviation|Mean
789492|NCT00865904|Secondary|Maximum Plasma Concentration (Cmax) of VX-809|Only participants who received VX-809 were analyzed for this outcome measure.|Day 1 (pre dose, 0.75, 1.5, 3, 4, 6, 9, 12, and 24 hours post-dose), Day 28 (pre dose, 0.75, 1.5, 3, 4, 6, 9, 12, 24, and 30-60 hours post dose)|FAS. Here, n = participants evaluable for specified category for each arm, respectively.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
789493|NCT00865904|Secondary|Change From Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Domain Scores at Day 28|The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. CFQ-R domains include: Body, Digestion, Eat, Emotion, Health Perceptions, Physical, Respiratory, Role, Social, Treatment Burden, Vitality, and Weight. Individual domain score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.|Baseline, Day 28|FAS. Number of participants analyzed signifies participants evaluable for this outcome.||units on a scale||95% Confidence Interval|Least Squares Mean
789494|NCT00865904|Secondary|Change From Baseline in Nasal Potential Difference (NPD) of Zero Chloride Plus Isoproterenol Response at Day 28|"Nasal potential difference (NPD) provides a direct and sensitive evaluation of sodium and chloride transport in secretory epithelial cells via assessment of transepithelial bioelectric properties. NPD under conditions of zero chloride concentration perfusion solution in the presence of isoproterenol is reported.
NPDs were performed according to Cystic Fibrosis Foundation Therapeutics Development Network (CFFT TDN) Standard Operating Procedure (SOP) 528.00 “Standardization of Measurement of Nasal Membrane Transepithelial Potential Difference (NPD) – electronic data capture (EDC) and Perfusion or Perfusion-Free Probe”."|Baseline, Day 28|FAS. Number of participants analyzed signifies participants evaluable for this outcome.||millivolts (mV)||95% Confidence Interval|Least Squares Mean
789495|NCT00865904|Secondary|Change From Baseline in Sweat Chloride at Day 28|Sweat samples were collected using an approved Macroduct (Wescor) collection device. A volume of greater than or equal to (>=) 15 microliter was required for determination of sweat chloride.|Baseline, Day 28|FAS. Number of participants analyzed signifies participants evaluable for this outcome.||millimole per liter (mmol/L)||95% Confidence Interval|Least Squares Mean
789496|NCT00865904|Secondary|Change From Baseline in Forced Expiratory Flow Over the Middle Half of the FVC (FEF25-75) at Day 28|FEF25-75 is total volume of air exhaled from the lungs over the middle half of the FVC test, expressed as liters per second (L/sec).|Baseline, Day 28|FAS. Number of participants analyzed signifies participants evaluable for this outcome.||liters per second (L/sec)||Standard Deviation|Mean
789497|NCT00865904|Secondary|Change From Baseline in Forced Vital Capacity (FVC) at Day 28|FVC is the volume of air that can be forcibly exhaled from the lungs after taking the deepest breath possible.|Baseline, Day 28|FAS. Number of participants analyzed signifies participants evaluable for this outcome.||liters||Standard Deviation|Mean
789498|NCT00865904|Secondary|Change From Baseline in Percent Predicted FEV1 at Day 28|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Predicted FEV1 (for age, gender, and height) was calculated using the Knudson method.|Baseline, Day 28|FAS. Number of participants analyzed signifies participants evaluable for this outcome.||Percent predicted of FEV1||95% Confidence Interval|Least Squares Mean
790243|NCT00871429|Primary|Product Satisfaction of the Following Test Articles A, B, and C: Lindi Skin Soothing Balm (Product A), Lindi Skin Face Serum (Product B), and Lindi Skin Face Wash (Product C)||one month of use|the number of participants for analysis was determined per protocol.||Percentage of Participants|||Number
789500|NCT00865904|Primary|Safety and Tolerability Based on Adverse Events (AEs)|AE: any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. AE includes serious as well as Non-serious AEs. Serious adverse event (SAE) (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Number of participants with AEs and SAEs are reported. An AE that started at or after initial dosing of study drug, or increased in severity after initial dosing of study drug visit is considered treatment-emergent.|Up to 14 days after last dose (last dose = Day 28)|Safety set included all participants who received at least 1 dose of study drug.||participants|||Number
789501|NCT00866034|Other Pre-specified|Endocrine Profile in the Early, Mid and Late Follicular Phase.|"difference in endocrine profile between the 2 arms during the mid and late follicular phase
influence of early elevated follicular phase progesterone levels on clinical outcome"|2 years||||||
789502|NCT00866034|Secondary|Cumulative Ongoing Pregnancy Rate||2 years|||cumulative ongoing pregnancy rate (%)|||Number
789503|NCT00866034|Primary|Live Birth Rate Per Started Cycle and Live Birth From Cryopreserved Embryos Originating From, and Occurring Within 6 Months of the Initial Treatment Cycle Will be Included in the Total Live Birth Rate Per Started Cycle.||2 years|||Cumulative live birth rate (%)|||Number
789504|NCT00866047|Secondary|Time of Maximum Serum Concentration|Time of maximum serum concentration from 0 to 21 days following the first dose of brentuximab vedotin|3 weeks|All participants who received treatment||days||Full Range|Median
789505|NCT00866047|Secondary|Maximum Serum Concentration|Maximum serum concentration from 0 to 21 days following the first dose of brentuximab vedotin|3 weeks|All participants who received treatment||microgram/mL||Geometric Coefficient of Variation|Geometric Mean
789506|NCT00866047|Other Pre-specified|B Symptom Resolution|Percentage of participants with lymphoma-related symptoms (B symptoms: fever, night sweats, or weight loss >10%) at baseline who achieved resolution of all B symptoms at any time during the treatment period.|up to 12 months|Participants with B symptoms at baseline||percent of participants||95% Confidence Interval|Number
789507|NCT00866047|Secondary|Area Under the Curve|Area under the serum concentration-time curve from time 0 to 21 days following the first dose of brentuximab vedotin|3 weeks|All participants who received treatment||day * microgram/mL||Geometric Coefficient of Variation|Geometric Mean
789508|NCT00866047|Secondary|Chemistry Laboratory Abnormalities >/= Grade 3|Counts of study participants with post-baseline chemistry laboratory abnormalities of Grade 3 or greater per NCI CTCAE version 3.0. Participants with multiple occurrences of a laboratory abnormality within a category are counted once in that category.|up to 12 months|All participants who received treatment||participants|||Number
789509|NCT00866047|Secondary|Hematology Laboratory Abnormalities >/= Grade 3|Counts of study participants with post-baseline hematology laboratory abnormalities of Grade 3 or greater per NCI CTCAE version 3.0. Participants with multiple occurrences of a laboratory abnormality within a category are counted once in that category.|up to 12 months|All participants who received treatment||participants|||Number
789510|NCT00866047|Secondary|Adverse Events by Severity, Seriousness, and Relationship to Treatment|Counts of participants who had adverse events or treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose). Serious adverse events are reported from the time of informed consent. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death). Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an adverse event within a category are counted once within the category.|up to 12 months|All participants who received treatment||participants|||Number
789511|NCT00866047|Secondary|Overall Survival|Time from start of study treatment to date of death due to any cause.|up to approximately 7 years|Intention to treat||months||95% Confidence Interval|Median
789512|NCT00866047|Secondary|Progression-free Survival by Kaplan-Meier Analysis|Time from start of study treatment to disease progression per independent review group or death due to any cause.|up to approximately 3 years|Intention to treat||months||95% Confidence Interval|Median
789513|NCT00866047|Secondary|Duration of Objective Response in Participants With Complete Remission by Kaplan-Meier Analysis|Duration of response from start of first objective tumor response (CR or PR) by independent review group to disease progression or death due to any cause in participants with CR.|up to approximately 3 years|Participants with complete remission among the intention to treat population||months||95% Confidence Interval|Median
789514|NCT00866047|Secondary|Duration of Objective Response by Kaplan-Meier Analysis|Duration of objective response (CR + PR) by independent review group, defined as time of initial response until disease progression or death.|up to approximately 3 years|Participants with objective response among the intention to treat population||months||95% Confidence Interval|Median
789515|NCT00866047|Secondary|Complete Remission Rate by Independent Review Group|Percentage of participants who achieved a best response of CR (disappearance of all evidence of disease) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.|up to 12 months|Intention to treat||percent of participants||95% Confidence Interval|Number
789516|NCT00866047|Primary|Objective Response Rate by Independent Review Group|Percentage of participants who achieved a best response of complete remission (CR, disappearance of all evidence of disease) or partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.|up to 12 months|Intention to treat||percent of participants||95% Confidence Interval|Number
789517|NCT00866177|Primary|Anti-tumor Response Defined as Either a CR, PR, or SD as Defined by RECIST|Anti-tumor response defined as either a Complete Response, Partial Response, or Stable Disease as defined by RECIST|Up to 4 weeks|||participants|||Number
789704|NCT00860262|Secondary|Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 4|Overall mean reduction from a common mean baseline in DBP|baseline and week 4|Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement.||mmHg (millimeters of mercury)||Standard Error|Least Squares Mean
789518|NCT00866281|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs or SAEs and Death During the Study|An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. A SAE was defined as an event which was fatal or life threatening, required or prolonged hospitalization, was significantly or permanently disabling or incapacitating, constituted a congenital anomaly or a birth defect, or encompassed any other clinically significant event that could jeopardize the participant or require medical or surgical intervention to prevent one of the aforementioned outcomes. Treatment related AEs or SAEs were defined as AEs or SAEs that were suspected to be related to study treatment as per investigator. On treatment death was a fatal event leading to permanent cessations of all vital functions of the body.|Baseline (start of study treatment) up to End of treatment (up to 24 months after last dose or until death whichever occurred first)|The analysis was performed in safety set population, defined as the participants who received at least one dose of midostaurin.||Participants|||Number
789519|NCT00866281|Secondary|Plasma Concentrations of Midostaurin and Its Metabolites CGP52421 and CGP62221|The plasma concentrations of midostaurin (PKC412) and its two major metabolites, CGP62221 and CGP52421 were determined by using a validated liquid chromatography/tandem mass spectrometry method.|Day 1, Day 5, Day 7, Day 15 (Day 1 of Cycle 2), Day 29 (Day 1 of Cycle 3)|The analysis was performed in pharmacokinetic (PK) set population defined as all safety set participants who had at least one valid (measurable) PK sample of midostaurin, and who had no significant restricted co-medications.||nanograms/milliliters (ng/mL)||Standard Deviation|Mean
789520|NCT00866281|Secondary|Overall Survival With Midostaurin|Overall survival (OS) was defined as the time from start of treatment to date of death due to any cause. The percentage (%) event-free probability estimates were obtained from the Kaplan-Meier survival estimates.|Baseline, End of treatment (up to 24 months after last dose or until death whichever occurred first)|The analysis was performed in FAS population.||Months||95% Confidence Interval|Median
789521|NCT00866281|Secondary|Time to Response With Midostaurin|Time to response was defined as the time from the date of start of midostaurin treatment to the date of first response. The best overall clinical response was determined as per the clinical assessment done by the investigator. Responders were defined as all participants with a best clinical response of leukemia free state, morphological complete remission, incomplete morphological complete remission, partial remission, bone marrow blast response, bone marrow minor blast response, peripheral blood blast response, minor peripheral blood blast response. Time to response was calculated by using the formula = (date of first response -date of start of midostaurin) +1 day.|Baseline, End of treatment (up to 24 months after last dose or until death whichever occurred first)|"The analysis was performed in FAS population. Here, Number of participants analysed signifies number of responders at specified time points for each arm, respectively."||Days||Full Range|Median
789522|NCT00866281|Secondary|Percentage of Participants With Best Overall Response by Indication|The best overall clinical response was determined as per the clinical assessment done by the investigator. Responders were defined as all participants with a best clinical response of leukemia free state, morphological complete remission, incomplete morphological complete remission, partial remission, bone marrow blast response, bone marrow minor blast response, peripheral blood blast response, minor peripheral blood blast response. Participants with stable disease, progressive disease and with missing tumour assessment or who discontinued the study or who died before having their first assessment were considered as non-responders. Stable disease was defined as failure to achieve any of the above response. Progressive disease was defined as doubling of the bone marrow blast percentage from baseline in participants with <40% bone marrow blasts at baseline, or a 50% increase in bone marrow blast percentage from baseline in participants with >40% bone marrow blasts at baseline,|Baseline, Day 15 (Day 1 of Cycle 2), Day 22 (Day 8 of Cycle 2), Day 29(Day 1 of Cycle 9), End of treatment (up to 24 months after last dose or until death whichever occurred first)|The analysis was performed in full analysis set (FAS) population, defined as all participants to whom study treatment was assigned.||Percentage of Participants|||Number
789523|NCT00866281|Primary|Maximum Tolerated Dose (MTD) of Midostaurin- Posterior Probability of DLT|MTD was defined as highest dose level for which no more than 1 participant in a dose cohort experienced dose limiting toxicity (DLT), based on a Bayesian logistic regression model (BLRM) employing the escalation with overdose control (EWOC) principle. A DLT was defined as a grade 3 or 4 non-hematological adverse event (AE) or abnormal laboratory value related to study drug. Mean and the 95% posterior probability estimates of having a DLT by age strata and dose is presented. Estimation of MTD and/or recommended dose for expansion (RDE) at the dose-escalation phase of the study was based upon the estimation of the probability of DLT for participants in the dose-determining set (DDS).|Baseline, End of dose escalation phase (6 months)|The analysis was performed in dose determining set (DDS) population. Here, 'n' signifies the number of evaluable participants for this measure.||probability estimates||97.5% Confidence Interval|Mean
789524|NCT00866294|Secondary|Percentage of Responders Based on the Clinical Global Impression-Global Improvement (CGI-GI) Scores at Weeks 4 and 8|The 7-point CGI-GI assesses the participant's improvement or worsening from baseline. Scores on the CGI-GI range from 1 = very much improved to 7 = very much worse. Responders are defined as participants with a score of 1 or 2 = much improved.|Weeks 4 and 8|FAS. The analysis was performed on the OC dataset. The analysis of Week 8 data was also performed on the LOCF dataset, where missing values were imputed by the last observed value in the longitudinal data. Some participants in each group were not included in the OC analysis because they had missing values or they were withdrawn prematurely.||percentage of responders|||Number
789525|NCT00866294|Secondary|Mean Change From Baseline in the Clinical Global Impression-Severity of Illness (CGI-SI) Scores at Weeks 1, 2, 3, 4, 6, and 8|The 7-point CGI-SI scale assesses the clinician’s impression of the participant's current illness state. Scores on the CGI-SI range from 1 = not ill at all to 7 = among the most extremely ill. Mean change from baseline was calculated as the value at each time point minus the baseline value.|Baseline (Week 0); Weeks 1, 2, 3, 4, 6, and 8|FAS. The analysis was performed on the OC dataset. The analysis of Week 8 data was also performed on the LOCF dataset, where missing values were imputed by the last observed value in the longitudinal data. Some participants in each group were not included in the OC analysis because they had missing values or they were withdrawn prematurely.||scores on a scale||Standard Deviation|Mean
790256|NCT00871689|Secondary|Incidence of Primary Graft Failure|Incidence of graft failure defined as an absolute neutrophil count of less than 500/uL and a bone marrow that is less than 5% cellular (marrow aplasia) on day 42.|Day 42|||Participants|||Number
789526|NCT00866294|Secondary|Percentage of HAM-D Remitters at Weeks 4 and 8|The HAM-D measures the severity of depressive symptoms in participants with MDD. It is a checklist of 17 items that are ranked on a scale of 0-4 or 0-2. The range for the total score (which is the sum of the scores of all 17 items) is 0-52; a higher score indicates greater severity of symptoms. Remitters are defined as participants with a HAM-D total score of 7 or less.|Weeks 4 and 8|FAS. The analysis was performed on the OC dataset. The analysis of Week 8 data was also performed on the LOCF dataset, where missing values were imputed by the last observed value in the longitudinal data. Some participants in each group were not included in the OC analysis because they were withdrawn prematurely.||percentage of remitters|||Number
789527|NCT00866294|Secondary|Percentage of HAM-D Responders at Weeks 4 and 8|The HAM-D measures the severity of depressive symptoms in participants with MDD. It is a checklist of 17 items that are ranked on a scale of 0-4 or 0-2. The range for the total score (which is a sum of the scores of all 17 items) is 0-52; a higher score indicates greater severity of symptoms. Responders are defined as participants with a 50 percent or greater reduction from baseline in the HAM-D total score.|Weeks 4 and 8|FAS. The analysis was performed on the OC dataset. The analysis of Week 8 data was also performed on the LOCF dataset, where missing values were imputed by the last observed value in the longitudinal data. Some participants in each group were not included in the OC analysis because they were withdrawn prematurely.||percentage of responders|||Number
789528|NCT00866294|Secondary|Mean Change From Baseline in the HAM-D Total Score at Weeks 1, 2, 3, 4, 6, and 8|The HAM-D measures the severity of depressive symptoms in participants with MDD. It is a checklist of 17 items that are ranked on a scale of 0-4 or 0-2. The range for the total score (which is the sum of the scores of all 17 items) is 0-52; a higher score indicates greater severity of symptoms. Mean change from baseline was calculated as the value at each time point minus the Baseline value.|Baseline (Week 0); Weeks 1, 2, 3, 4, 6, and 8|FAS. The analysis was performed on the following datasets: the observed case (OC) dataset for Week 1 and the LOCF dataset for Weeks 2, 3, 4, 6, and 8, where missing values were imputed by the last observed value in the longitudinal data. One participant in the Paroxetine CR group was not included in the OC analysis for having a missing value.||scores on a scale||Standard Deviation|Mean
789529|NCT00866294|Primary|Adjusted Mean Change From Baseline in the Hamilton Depression Rating Scale (HAM-D; 17 Items) Total Score at Week 8|The HAM-D measures the severity of depressive symptoms in participants with major depressive disorder (MDD). It is a checklist of 17 items that are ranked on a scale of 0-4 or 0-2. The range for the total score (which is the sum of the scores of all 17 items) is 0-52; a higher score indicates greater severity of symptoms. Mean change from baseline was calculated as the value at Week 8 minus the Baseline value.|Baseline (Week 0) and Week 8|Full Analysis Set (FAS): all participants who entered the treatment phase (8 weeks), excluding those who had taken no dose of the investigational product for the treatment phase and who had no data on the HAM-D total score after the start of the treatment phase. The analysis was performed on the last observation carried forward (LOCF) dataset.||scores on a scale||Standard Error|Mean
789530|NCT00866307|Primary|AALL08P1 Feasibility Outcome|Percentage of Group B (High Risk-High) patients that tolerate at least 8 of the 12-14 total doses of pegaspargase during Consolidation, Interim Maintenance, and Delayed Intensification periods. Only Grp B analyzed since this is prespecified in protocol.|Consolidation through Delayed Intensification|Patients with High Risk-high Acute Lymphoblastic Leukemia (ALL)||percentage of participants||90% Confidence Interval|Number
789531|NCT00866307|Primary|AALL08P1 Safety Outcome|Percentage of Group B (High Risk-High) patients taking less than 49 weeks from day 1 of consolidation to day 1 of maintenance therapy. Only Group B analyzed since this is prespecified in protocol.|Consolidation through Delayed Intensification|Patients with High Risk-High (Group B) Acute Lymphoblastic Leukemia (ALL)||percentage of participants||90% Confidence Interval|Number
789532|NCT00866320|Secondary|Duration of Overall Response (Tumor Burden Reduction)|Measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented.|followed for overall response for approximately 3 years|Patients who achieved at least 5% tumor reduction||months||95% Confidence Interval|Median
789533|NCT00866320|Secondary|Time to Progression|"Time to objective progression will be measured from the start of treatment until the criteria for RECIST-defined progression are met, taking as reference the smallest measurements recorded since the treatment started, including baseline.
Progression-free survival measured in months and summarized using the Kaplan-Meier method."|followed to progression for approximately 3 years|All patients who started treatment||months||95% Confidence Interval|Median
789534|NCT00866320|Secondary|Overall Survival|Overall survival measured in months and summarized using the Kaplan-Meier method. This will be calculated from the date of registration on-study to the dates of documented evidence of progression and death, respectively.|followed until progression or death for approximately 3 years|All patients who started treatment||months||95% Confidence Interval|Median
789535|NCT00866320|Primary|Tumor Burden Reduction Rate (TBRR)|The primary endpoint of the study is defined as the percentage of patients who experience larger than or equal to 5% reduction in tumor burden as measured by RECIST-defined target lesions without progression of non-target lesions or the appearance of any new lesions, confirmed at least 4 weeks after first documentation. RECIST criteria will be used for the purpose of designating target lesions, calculating total tumor burden (the sum of the unidimensional measurement of target lesions) and defining disease progression.Additional RECIST-defined partial or complete responses will be recorded.|at 8 weeks (2cycles of treatment)|All patients who started treatment||percentage of patients|||Number
790257|NCT00871689|Primary|Number of Patients With Neutrophil Engraftment|Number of patient with absolute neutrophils >500*10^8/kg by 42 days post transplant.|Day 42|||Participants|||Number
793718|NCT00908583|Primary|Number of Living Donor Transplant Candidates That Are Transplanted|Number of living donor transplant candidates who convert to a negative flow T- and B-cell crossmatch via desensitization and are subsequently transplanted|1 year post baseline|||participants|||Number
789560|NCT00866606|Secondary|Percentage of Participants With Red Blood Cell (RBC) Agglutination|RBC Agglutination is the clumping of red blood cells in the presence of an antibody. The antibody or other molecule bonded multiple particles and joined them, creating a large complex.|Baseline up to 6 months|SS population included all enrolled participants who had taken at least 1 dose of drug.||Percentage of Participants|||Number
789561|NCT00866606|Secondary|Percentage of Participants With Thrombosis|Thrombosis is the formation of a blood clot (thrombus) inside a blood vessel, obstructing the flow of blood through the circulatory system. When a blood vessel is injured, the body uses platelets and fibrin to form a blood clot to prevent blood loss.|Baseline up to 6 months|SS population included all enrolled participants who had taken at least 1 dose of drug.||Percentage of Participants|||Number
789562|NCT00866606|Secondary|Percentage of Participants With Allergic-Type Allergic Reactions|Hypersensitivity to undesirable (damaging, discomfort-producing and sometimes fatal) reactions produced by the normal immune system. Hypersensitivity reactions require a pre-sensitized (immune) state of the host.|Baseline up to 6 months|SS population included all enrolled participants who had taken at least 1 dose of drug.||Percentage of Participants|||Number
789563|NCT00866606|Secondary|Percentage of Participants With Less Than Expected Therapeutic Effect (LETE)|The incidence of LETE for on-demand treatment was defined as no response after each of 2 successive infusions within 24 hours for the same bleeding event in the absence of confounding factors.|Baseline up to 6 months|FAS population included all participants who were treated and had at least 1 evaluable efficacy assessment after treatment.||Percentage of Participants|||Number
789564|NCT00866606|Secondary|FIX Incremental Recovery|FIX recovery was assessed by evaluating FIX:C after initial exposure and following 6 months of repeated exposures to BeneFIX. A modified FIX recovery study was performed at Day 1 (Visit 2) and Month 6/Final/Early Termination visits (Visit 4) and when clinically indicated at the applicable on-demand visits. Blood samples for determination of FIX:C were collected immediately before BeneFIX infusion and at 30 minutes (±5 minutes) after the start of infusion. Post-infusion blood samples were collected via venipuncture in arm contralateral to arm used for infusion.|Baseline (Visit 2) up to 6 months (Visit 4)|FAS population included all participants who were treated and had at least 1 evaluable efficacy assessment after treatment. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each visit respectively.||IU/dL per IU/kg||Standard Deviation|Mean
789565|NCT00866606|Secondary|Number of Infusions Required to Treat Each Bleed|The number of BeneFIX infusions required to treat each bleeding episode were analyzed. The average frequency of BeneFIX infusions per hemorrhage incidence to treat every hemorrhage was equal to the total number of injections throughout the study divided by total number of hemorrhagic events.|Baseline up to 6 months|FAS population included all participants who were treated and had at least 1 evaluable efficacy assessment after treatment.||Infusions||Standard Deviation|Mean
789566|NCT00866606|Primary|Percentage of Participants With FIX Inhibitor Development|Incidence of FIX inhibitor was defined as any result determined as positive at local laboratory, and confirmed at central laboratory with Nijmegen assay result >=0.6 Bethesda Unit (BU). Incidence was stratified by participant exposure history - Minimally Treated Patients (MTPs): those who had received at least one prior FIX infusion, and <= 100 documented Exposure Days (EDs); while Previously Treated Patients (PTPs): those who had received >100 documented prior EDs. When number of prior EDs for an individual was not known to be at least 100, participants were included in the MTP population.|Baseline up to 6 months|Safety Set (SS) population included all enrolled participants who had taken at least 1 dose of drug.The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each visit respectively.||Percentage of Participants|||Number
789567|NCT00866606|Primary|Investigator Hemostatic Efficacy Assessment of Participants After 24 Hours Post Infusion|Investigator Hemostatic Efficacy Assessment was based on response of bleeding episodes to BeneFIX treatment on 4-point rating scale: Excellent(1): definite pain relief or improvement in signs of bleeding starting within 8 hrs after infusion, with no additional infusion; Good(2): definite pain relief or improvement in signs of bleeding starting within 8 hrs or following infusion; Moderate(3): probable or slight improvement starting after 8 hours following infusion; No Response(4): no improvement at all between infusions or during 24 hour interval following an infusion, or condition worsens.|24 hours post infusion|FAS population included all participants who were treated and had at least 1 evaluable efficacy assessment after treatment.||Units on a scale||Standard Deviation|Mean
789568|NCT00866606|Primary|Investigator Hemostatic Efficacy Assessment of Participants After 8 Hours Post Infusion|Investigator Hemostatic Efficacy Assessment was based on response of bleeding episodes to BeneFIX treatment on 4-point rating scale: Excellent(1): definite pain relief or improvement in signs of bleeding starting within 8 hrs after infusion, with no additional infusion; Good(2): definite pain relief or improvement in signs of bleeding starting within 8 hrs or following infusion; Moderate(3): probable or slight improvement starting after 8 hours following infusion; No Response(4): no improvement at all between infusions or during 24 hour interval following an infusion, or condition worsens.|8 hours post infusion|FAS population included all participants who were treated and had at least 1 evaluable efficacy assessment after treatment.||Units on a scale||Standard Deviation|Mean
789569|NCT00866658|Other Pre-specified|Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia|Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the patient required the assistance of another person and was associated with either a plasma glucose less than 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.|First dose of study drug up to 3 days after the last dose administration|Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.||participants|||Number
789570|NCT00866658|Secondary|Percentage of Patients Requiring Rescue Therapy During 24-Week Period|Routine fasting SMPG and central laboratory FPG (and HbA1c after week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after week 12) were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG >270 milligram/deciliter (mg/dL) (15.0 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 24: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >8.5%. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline up to Week 24|mITT population.||percentage of participants|||Number
789571|NCT00866658|Other Pre-specified|Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.||percentage of participants|||Number
789572|NCT00866658|Other Pre-specified|Change From Baseline in Glucose Excursion at Week 24|Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the standardized meal test, before study drug administration. Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of the study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline glucose excursion assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
789573|NCT00866658|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 24|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.||percentage of participants|||Number
789705|NCT00860262|Secondary|Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 6|Overall mean reduction from a common mean baseline in DBP|baseline and week 6|Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement.||mmHg (millimeters of mercury)||Standard Error|Least Squares Mean
789574|NCT00866658|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.||percentage of participants|||Number
789575|NCT00866658|Secondary|Change From Screening in Total Insulin Dose at Week 24|Change was calculated by subtracting screening value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Screening, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post baseline insulin dose assessment during on-treatment period.||units per day||Standard Error|Least Squares Mean
789576|NCT00866658|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 1 day after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline FPG assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
789577|NCT00866658|Secondary|Change From Baseline in Average 7-Point Self Monitored Plasma Glucose (SMPG) Profile at Week 24|Patients recorded a 7-point plasma glucose profile measured before and 2 hours after each meal and at bedtime once in a week and the average value for the 7-time points was calculated. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline average 7-point SMPG assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
789578|NCT00866658|Secondary|Change From Baseline in Body Weight at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.||kilogram||Standard Error|Least Squares Mean
789579|NCT00866658|Secondary|Change From Baseline in 2-hour Postprandial Plasma Glucose (PPG) at Week 24|The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using last observation carried forward (LOCF). Here, number of patients analyzed = patients with baseline and at least 1 post-baseline 2-hour PPG assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
789580|NCT00866658|Primary|Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population:all randomized patients who received at least 1 dose;had baseline,at least 1 post-baseline efficacy assessment, irrespective of compliance with study protocol/procedures. Last observation carried forward used. Number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on treatment period.||percentage of hemoglobin||Standard Error|Least Squares Mean
789581|NCT00866697|Secondary|Number of Participants With the Indicated Treatment-emergent Thyroid-stimulating Hormone (TSH) Elevations Above 5 Million Units Per Liter (MU/L)|Participants were assessed for thyroid function abnormalities. Clinical hypothyroidism is defined as 5 <TSH <=10 MU/L and T4 <lower limit of normal (LLN).|From the date of the first dose of study drug to the date of the last dose plus 28 days (average of 9.8 months for pazopanib and 12.6 months for placebo)|All Treated Population. Only those participants with any TSH above 5 MU/L were analyzed.||participants|||Number
789582|NCT00866697|Secondary|Number of Participants With the Indicated On-therapy Chemistry Grade Shifts From Baseline Grade|Hematology toxicities were graded according to the Common Terminiology Criteria for Adverse Events (CTCAE), Version 4.0. Grade refers to the severity of the toxicity. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on this general guideline: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life threatening; Grade 5, death. Participants with a missing Baseline grade were assumed to have a Baseline grade of 0.|From the date of the first dose of study drug to the date of the last dose plus 28 days (average of 9.8 months for pazopanib and 12.6 months for placebo)|All Treated Population. Only those participants contributing toxicity data were analyzed.||participants|||Number
789706|NCT00860262|Secondary|Change From Baseline in Trough Seated Diastolic Blood Pressure (DBP) at Week 8|Overall mean reduction from a common mean baseline in DBP|baseline and week 8|Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement.||mmHg (millimeters of mercury)||Standard Error|Least Squares Mean
789583|NCT00866697|Secondary|Number of Participants With the Indicated On-therapy Hematology Grade Shifts From Baseline Grade|Hematology toxicities were graded according to the Common Terminiology Criteria for Adverse Events (CTCAE), Version 4.0. Grade refers to the severity of the toxicity. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on this general guideline: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life threatening; Grade 5, death. Participants with a missing Baseline grade were assumed to have a Baseline grade of 0. WBC=White blood cell.|From the date of the first dose of study drug to the date of the last dose plus 28 days (average of 9.8 months for pazopanib and 12.6 months for placebo)|All Treated Population. Only those participants contributing toxicity data were analyzed.||participants|||Number
789584|NCT00866697|Secondary|Number of Participants With the Indicated Grade 2, 3, and 4 On-therapy Adverse Events Occurring in >=10% of Participants in Either Treatment Arm|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs were graded according to the Common Terminiology Criteria for Adverse Events (CTCAE), Version 4.0. Grade refers to the severity of the AE. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life threatening; Grade 5, death.|From the date of the first dose of study drug to the date of the last dose plus 28 days (average of 9.8 months for pazopanib and 12.6 months for placebo)|All Treated Population||participants|||Number
789585|NCT00866697|Secondary|Number of Participants With Any Serious Adverse Event (SAE) and Any Adverse Event|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgement was to be exercised in deciding whether reporting was appropriate in other situations, such as important medical events that may not be immediately life threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition.|From the date of the first dose of study drug to the date of the last dose plus 28 days (average of 9.8 months for pazopanib and 12.6 months for placebo)|All Treated Population: all randomized participants who received at least one dose of investigational product, based on the actual treatment received if this differed from that to which the participant was randomized||participants|||Number
789586|NCT00866697|Secondary|Change From Baseline in the EQ-5D (Five Dimensions) Utility Score at Week 13 and Months 7, 10, 13, 16, and 25|The EQ-5D utility score captures health status across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety and/or depression. Participants indicated the level of perceived problems in each of the five dimensions on three levels: 1, no problems; 2, some problems; 3, an extreme problem. Unique health states were defined by combining response levels from each of the five dimensions. For example, state 11111 indicates no problem on any of the five dimensions, whereas state 11223 indicates no problems with mobility or self-care; some problems with performing usual activities, moderate pain/discomfort; and extreme anxiety/depression. Responses are typically converted into health utilities or valuations on a scale ranging from 0 (worst health) to 1 (perfect health). A negative adjusted mean change from Baseline represents a worsening of quality of life. Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA.|Baseline; Week 13; Months 7, 10, 13, 16, and 25|ITT Population. Only those participants available at the specified time points were analyzed.||scores on a scale||Standard Error|Least Squares Mean
789587|NCT00866697|Secondary|Change From Baseline in the EuroQOL EQ-5D (Five Dimensions) Thermometer Score at Week 13 and Months 7, 10, 13, 16, and 25|The EuroQol (EQ-5D) questionnaire is a 2-page, generic, preference-based quality of life measure comprised of a 5-item health status measure and a visual analogue scale (VAS) and is used to generate two scores: the utility score and the thermometer score The thermometer score is based on a vertical VAS. The VAS is designed like a thermometer scale on which the best health state the participant can imagine is referenced at 100, and the worst health state the participant can imagine is marked by 0. Based on how good or bad the current health state is, the participant is asked to draw a line across the thermometer scale. For example, a line drawn across 46 on the scale of 0 to 100 would be coded 46. A negative adjusted mean change from Baseline represents a worsening of quality of life. Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA.|Baseline; Week 13; Months 7, 10, 13, 16, and 25|ITT Population. Only those participants available at the specified time points were analyzed.||scores on a scale||Standard Error|Least Squares Mean
789588|NCT00866697|Secondary|Change From Baseline in QLQ-OV-28 Module Other Chemotherapy Side Effects (SE) Symptoms Score at Week 13 and Months 7, 10, 13, 16, and 25|The OV-28 module is a 28-item addition to the EORTC QLQ-C30 that focuses on issues specific to ovarian cancer. It assesses other chemotherapy SE symptoms, among others. Participants were asked to indicate the extent to which they experienced other chemotherapy SE symptoms/problems in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following questions: Have you lost any hair?; If yes, were you upset by the loss of your hair?; Did food/drink taste different from usual?; Did you have aches or pains in your muscles or joints?; Did you have problems with hearing?; Did you urinate frequently?; Have you had skin problems (e.g., itchy, dry)? Data are transformed to a scale from 0 to 100. Lower scores represent better health (fewer symptoms) for symptom scales. Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA. Data were not analyzed due to low compliance (<50% at Baseline).|Baseline; Week 13; Months 7, 10, 13, 16, and 25||||||
789602|NCT00866775|Secondary|Standardized Seizure Frequency (SSF) by Period|Seizure frequency was evaluated by using a standardized frequency per 4 weeks (28 days). It was evaluated for five periods: baseline (Weeks -8 to -1), titration (Weeks 1 to 2), AED taper/conversion (Weeks 3 to 8), monotherapy (Weeks 9 to 18), and double-blind (Weeks 1 to 18).|Week 1 to Week 18, Double-blind: weeks 1 to 18; Baseline: weeks -8 to -1; Titration: weeks 1 to 2; AED taper/conversion: weeks 3 to 8; Monotherapy: weeks 9 to 18|efficacy population (ESL 1200 mg) Double-blind: 60; Baseline: 60; Titration: 60; AED taper/conversion: 60; Monotherapy: 43 (ESL 1600 mg) Double-blind: 118; Baseline: 118; Titration: 118; AED taper/conversion: 114; Monotherapy: 93||Number of seizures in 28 days||Standard Deviation|Mean
789589|NCT00866697|Secondary|Change From Baseline in QLQ-OV-28 Module Sexuality Functional on Day 1 of Week 13 and Months 7, 10, 13, 16, and 25|The OV-28 module is a 28-item addition to the EORTC QLQ-C30 that focuses on issues specific to ovarian cancer. It assesses sexual functioning symptoms, among others. Participants were asked to indicate the extent to which they experienced sexual functioning problems in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following questions: To what extent were you interested in sex?; To what extent were you sexually active?; If sexually active, to what extent was sex enjoyable for you?; If sexually active, did you have a dry vagina during sexual activity? Higher scores represent better functioning (better quality of life). Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA. Data were not analyzed due to low compliance (<50% at Baseline).|Baseline; Week 13; Months 7, 10, 13, 16, and 25||||||
789590|NCT00866697|Secondary|Change From Baseline in QLQ-OV-28 Module Hormonal/Menopausal Symptoms Score at Week 13 and Months 7, 10, 13, 16, and 25|The OV-28 module is a 28-item addition to the EORTC QLQ-C30 that focuses on issues specific to ovarian cancer. It assesses hormonal/menopausal symptoms, among others. Participants were asked to indicate the extent to which they experienced hormonal/menopausal symptoms or problems in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following questions: Did you have hot flashes?; Did you have night sweats? Data are transformed to a scale from 0 to 100. Lower scores represent better health (fewer symptoms) for symptom scales. Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA.|Baseline; Week 13; Months 7, 10, 13, 16, and 25|ITT Population. Only those participants available at the specified time points were analyzed.||scores on a scale||Standard Error|Least Squares Mean
789591|NCT00866697|Secondary|Change From Baseline in QLQ-OV-28 Module Abdominal (AB)/Gastrointestinal (GI) Symptoms Score at Week 13 and Months 7, 10, 13, 16, and 25|The OV-28 module is a 28-item addition to the EORTC QLQ-C30 that focuses on issues specific to ovarian cancer. It assesses AB/GI symptoms, among others. Participants were asked to indicate the extent to which they experienced AB/GI symptoms or problems in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following questions: Did you have abdominal pain?; Did you have a bloated feeling in your abdomen/stomach?; Did you have problems with your clothes feeling too tight?; Did you experience any change in bowel habit as a result of your disease or treatment?; Were you troubled by passing wind/gas/flatulence?; Have you felt full too quickly after beginning to eat?; Have you had indigestion/heartburn? Data are transformed to a scale from 0 to 100. Lower scores represent better health (fewer symptoms) for symptom scales. Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA.|Baseline; Week 13; Months 7, 10, 13, 16, and 25|ITT Population. Only those participants available at the specified time points were analyzed.||scores on a scale||Standard Error|Least Squares Mean
789592|NCT00866697|Secondary|Change From Baseline in QLQ-OV-28 Module Peripheral Neuropathy (PN) Symptoms Score at Week 13 and Months 7, 10, 13, 16, and 25|The OV-28 module is a 28-item addition to the EORTC QLQ-C30 that focuses on issues specific to ovarian cancer. It assesses peripheral neuropathy symptoms, among others. Participants were asked to indicate the extent to which they experienced peripheral neuropathy symptoms or problems in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following questions: Did you have tingling hands or feet?; Have you had numbness in your fingers or toes?; Have you felt weak in your arms or legs? Data are transformed to a scale from 0 to 100. Lower scores represent better health (fewer symptoms) for symptom scales. Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA.|Baseline; Week 13; Months 7, 10, 13, 16, and 25|ITT Population. Only those participants available at the specified time points were analyzed.||scores on a scale||Standard Error|Least Squares Mean
789593|NCT00866697|Secondary|Change From Baseline in QLQ-OV-28 Module Body Image Functional Score on Day 1 of Week 13 and Months 7, 10, 13, 16, and 25|The OV-28 module is a 28-item addition to the EORTC QLQ-C30 that focuses on issues specific to ovarian cancer. It assesses body image symptoms, among others. Participants were asked to indicate the extent to which they experienced body image problems in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following questions: Have you felt physically less attractive as a result of your disease or treatment?; Have you been dissatisfied with your body? Data are transformed to a scale ranging from 0 to 100. Higher scores represent better functioning (better quality of life). Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA.|Baseline; Week 13; Months 7, 10, 13, 16, and 25|ITT Population. Only those participants available at the specified time points were analyzed.||scores on a scale||Standard Error|Least Squares Mean
789594|NCT00866697|Secondary|Change From Baseline in QLQ-OV-28 Module Attitude to Disease/Treatment Functional Score on Day 1 of Week 13 and Months 7, 10, 13, 16, and 25|The OV (ovarian)-28 module is a 28-item addition to the EORTC QLQ-C30 that focuses on issues specific to ovarian cancer. It assesses attitude to disease/treatment functional symptoms, among others. Participants were asked to indicate the extent to which they experienced attention to disease/treatment functional problems in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following questions: How much has your disease been a burden to you?; How much has your treatment been a burden to you?; Were you worried about your future health? Data are transformed to a scale ranging from 0 to 100. Higher scores represent better functioning (better quality of life). Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA.|Baseline; Week 13; Months 7, 10, 13, 16, and 25|ITT Population. Only those participants available at the specified time points were analyzed.||scores on a scale||Standard Error|Least Squares Mean
789603|NCT00866775|Secondary|Proportion (%) of Events in Each Classification of the Columbia Suicide Severity Rating Scale (C SSRS).||18 Week Double-blind treatment period|ITT population||Percent of participants|||Number
789604|NCT00866775|Secondary|Proportion (%) of Subjects With Normal Baseline Sodium Reaching Blood Sodium ≤135 mmol/L, ≤130 mmol/L, and ≤125 mmol/L|Proportion (%) of Subjects With Normal Baseline Sodium Reaching Blood Sodium ≤135 mmol/L, ≤130 mmol/L, and ≤125 mmol/L|18 Week Double-blind treatment period|ITT population||Percent|||Number
789605|NCT00866775|Secondary|Percentage of Subjects With Increase of Body Weight >= 7%||18 Week Double-blind treatment period|ITT population||Percentage of participants|||Number
789595|NCT00866697|Secondary|Change From Baseline in the European Organization for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status Score on Day 1 of Week 13 and Months 7, 10, 13, 16, and 25|"The EORTC QLQ-C30 is a self-reported, 30-item cancer-specific instrument that assesses 15 domains: 5 functional scales (physical, role, emotional, cognitive, and social functioning), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties), and a global health status, or quality of life. Global health status is assessed using a 7-item Likert scale, ranging from 1 to 7 (poor to excellent). Participants were asked to respond to the following questions using the 7-item Likert scale: How would you rate your overall health during the past week; How would you rate your overall quality of life during the past week? Data are transformed to a scale ranging from 0 to 100. Higher scores represent better functioning (better quality of life). Mean changes from Baseline were calculated via mixed model-repeated measures analysis of covariance (ANCOVA)."|Baseline; Week 13; Months 7, 10, 13, 16, and 25|ITT Population. Only those participants available at the specified time points were analyzed.||scores on a scale||Standard Error|Least Squares Mean
789596|NCT00866697|Secondary|3-year Progression-free Survival|3-year progression-free survival is defined as the percentage of participants who are progression-free at 3 years from randomization. Progression-free survival is defined as the time from the date of randomization to the earliest date of disease progression (defined by RECIST) or death due to any cause. Per RECIST, for target lesions, disease progression (PD) is defined as at least a 20% increase in the sum of the longest diameters (LD) of target lesions, taking as a reference, the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. For non-target lesions, PD is defined as the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|Up to 3 years after randomization|ITT Population||percentage of participants|||Number
789597|NCT00866697|Secondary|Progression-free Survival Per Gynecologic Cancer Intergroup (GCIG) Criteria|Progression-free survival by GCIG criteria is defined as the time from the date of randomization to the earliest date of disease progression per GCIG criteria or death due to any cause. Progression is defined according to RECIST but can also be based upon serum CA-125. Progression or recurrence based on serum CA-125 levels are defined on the basis of a progressive serial elevation of serum CA-125, according to the following criteria: (1) participants (par.) with elevated CA-125 pretreatment and normalization of CA-125 must show evidence of CA-125 >=2x the upper normal limit (UNL) on two occasions at least one week apart or; (2) par. with elevated CA-125 pretreatment, which never normalizes, must show evidence of CA-125 >=2x the nadir value on two occasions at least one week apart or; (3) par. with CA-125 in the normal range pretreatment must show evidence of CA-125 >=2x the UNL on two occasions at least one week apart.|From the date of randomization until the date of progression per GCIG criteria or death due to any cause (median time of follow-up was 16.8 months for pazopanib and 11.9 months for placebo)|ITT Population. For participants who did not progress or die, progression-free survival was censored at the time of the last adequate disease assessment.||months||95% Confidence Interval|Median
789598|NCT00866697|Secondary|Overall Survival|Overall surival is defined as the interval between the date of randomization and the date of death due to any cause. For participants who did not die, the time to death was censored at the time of last contact.|From the date of randomization until the date of death due to any cause (median time of follow-up was 24.3 months on pazopanib and 24.2 months on placebo)|ITT Population||months||95% Confidence Interval|Median
789599|NCT00866697|Primary|Investigator-assessed Progression-free Survival (PFS)|PFS is the interval between the date of randomization and the date of progression, defined by Response Evaluation Criteria in Solid Tumors (RECIST), or death due to any cause. Per RECIST, for target lesions (TLs), disease progression (PD) is defined as >=20% increase in the sum of the longest diameters (LD) of TLs, taking as a reference, the smallest sum LD recorded since the treatment started or the appearance of >=1 new lesions. For non-target lesions (NTLs), PD is defined as the appearance of >=1 new lesions and/or unequivocal progression of existing NTLs. Participants (par.) who did not progress/die were censored at the date of last adequate assessment (LAA). Par. who started a new anti-cancer therapy (ACT) prior to radiological progression/death were censored at the date of LAA prior to the new ACT. Par. who progressed/died after an extended period (>=12 months) without adequate assessment (AA) were censored at the date of their last visit with AA prior to progression/death.|From the date of randomization until the date of progression or death due to any cause (median time of follow-up was 17.9 months for pazopanib and 12.3 months for placebo)|Intent-to-Treat (ITT) Population: all randomized participants||months||95% Confidence Interval|Median
789600|NCT00866723|Primary|Clinical Benefit Response Rate|Clinical benefit response was defined as absence of disease progression at 18 weeks (ie after 6 cycles). Disease progression (PD) could occur per RECIST 1.0 or based on CA-125 levels. Per RECIST 1.0 for target lesions, PD is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or appearance of new lesions. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Disease progression based on CA-125 level was doubling of the CA-125 level from baseline. For patients with normal baseline CA-125 (who by definition had MD) the criterion for progression based on CA-125 doubling was doubling of CA-125 from the upper limit of normal (i.e. more than 70).|Disease was evaluated at baseline and every 3 cycles on treatment. Treatment continued until disease progression or unacceptable toxicity. Patients underwent radiologic assessment (CT or MRI scans) and CA-125 levels were measured.|The analysis dataset is comprised of all treated patients.||proportion of particpants||90% Confidence Interval|Number
789601|NCT00866723|Primary|Clinical Response Rate|For measurable disease (MD) patients, clinical response on treatment was based on RECIST 1.0 criteria with overall response defined as achieving partial response (PR) or complete response (CR). Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. For non-MD patients, clinical response based on modified Gynecologic Cancer Intergroup (GCIG) criteria was defined as at least a 50% decrease in CA-125 levels.|Disease was evaluated at baseline and every 3 cycles on treatment. Treatment continued until disease progression or unacceptable toxicity. Patients underwent radiologic assessment (CT or MRI scans) and CA-125 levels were measured.|The analysis dataset is comprised of all treated patients.||proportion of participants||90% Confidence Interval|Number
789606|NCT00866775|Secondary|Change in Total Score From Baseline in MADRS in Those Subjects With a MADRS Score of ≥14 at Randomization.|The total score of MADRS is defined as the sum of all individual symptom scores, ranging from 0 to 60, higher score indicates more severe depression. Each of the 10 symptoms of depression on MADRS was measured on a scale of 0 to 6 with 0 representing the lowest severity of the symptom and 6 representing the highest severity|Week 0 to Week 18, Baseline: Day 0; End of AED taper/conversion period: end of week 8; End of monotherapy period: end of week 18|efficacy population (ESL 1200 mg) Change from baseline to end of AED taper/conversation period: 7; Change from baseline to end of monotherapy period: 6 (ESL 1600 mg) Change from baseline to end of AED taper/conversation period: 13; Change from baseline to end of monotherapy period: 13||units on a scale||Standard Deviation|Mean
789607|NCT00866775|Secondary|Change in Total Score From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS).|The total score of MADRS is defined as the sum of all individual symptom scores, ranging from 0 to 60, higher score indicates more severe depression. Each of the 10 symptoms of depression on MADRS was measured on a scale of 0 to 6 with 0 representing the lowest severity of the symptom and 6 representing the highest severity|Week 0 to Week 18; Baseline: day 0; End of AED taper/conversion period: end of week 8; End of monotherapy period: end of week 18|efficacy population (ESL 1200 mg) Change from baseline to end of AED taper/conversion period: 45; Change from baseline to end of monotherapy period: 41 (ESL 1600 mg) Change from baseline to end of AED taper/conversion period: 92; Change from baseline to end of monotherapy period: 91||units on a scale||Standard Deviation|Mean
789608|NCT00866775|Secondary|Change in Total Score From Baseline in 31-Item Quality of Life in Epilepsy (QOLIE-31).|The QOLIE-31 overall score was obtained by using a weighted average of multi-item scale scores. The recorded responses were converted to 0-100 point scales. The mean of the individual item scores in each subgroup were calculated, with higher converted scores reflecting better quality of life.|Week 0 to Week 18, baseline: day 0: End of AED taper/conversion period: end of week 8; End of monotherapy period: end of week 18|the numbers analyzed represent all participants for whom data were available at baseline (ESL 1200 mg)Change from baseline to end of AED taper/conversion period: 39;Change from baseline to end of monotherapy period:36 (ESL1600 mg) Change from baseline to end of AED taper/conversion period: 86;Change from baseline to end of monotherapy period: 86||units on a scale||Standard Deviation|Mean
789609|NCT00866775|Secondary|Percentage of Subjects Reaching Each of the Exit Events.|The percentage of subjects reaching each of the 5 exit criteria. 1.One episode of status epilepticus.2.One secondary general partial seizure (in subjects who did not have gen. seizures during 6 months prior to screening).3.A two fold increase in any consecutive 28 day seizure rate compared to the highest consecutive 28 day seizure rate during the 8 wk baseline period. 4.A two fold increase in any consecutive 2 day seizure rate compared to the highest consecutive 2 day seizure rate during the 8 wk baseline period. If the highest number of seizures in any consecutive 2 day period during the 8 wk baseline was 1 then 3 seizures in a consecutive 2 day period was required to exit.5.Worsening of seizures or increase in seizure frequency considered serious or requiring intervention as judged by the Investigator.|Week 1 to Week 18|efficacy population||percentage of participants|||Number
789610|NCT00866775|Secondary|Responder Rate (Proportion [%] of Subjects With a ≥50% Reduction of Seizure Frequency From Baseline).|Responder rate was defined as the proportion (%) of subjects with a ≥ 50% reduction of seizure frequency from baseline. This analysis was done for the titration (Weeks 1 to 2), AED taper/conversion (Weeks 3 to 8), monotherapy (Weeks 9 to 18), and double-blind (Weeks 1 to 18) periods.|Week 0 to Week 18, Double blind: weeks to 8; baseline:weeks -8 to -1; titration: weeks 1 to 2; AED taper/conversion: weeks 3 to 8; monotherapy: weeks 9 to 18|efficacy population||percentage of participants||95% Confidence Interval|Number
789611|NCT00866775|Secondary|Change in Seizure Frequency From Baseline.|The relative (%) change in standardized seizure frequency was evaluated for four periods: titration (Weeks 1 to 2), AED taper/conversion (Weeks 3 to 8), monotherapy (Weeks 9 to 18), and double-blind (Weeks 1 to 18).|Week 0 to Week 18, Double-blind: weeks 1to 18; baseline:weeks-8 to -1; Titration: weeks 1 to 2; AED taper/conversion:weeks 3 to 8; monotherapy: weeks 9 to 18|efficacy population (ESL 1200 mg) Double-blind: 60;Titration: 60; AED taper/conversion: 60; Monotherapy: 43 (ESL 1600 mg) Double-blind: 118; Titration: 118; AED taper/conversion:114; Monotherapy:93||percent change||Inter-Quartile Range|Median
789612|NCT00866775|Secondary|Time on Eslicarbazepine Acetate Monotherapy.|The start of the monotherapy period was defined as the date of termination of all other AEDs while taking study monotherapy medication. Time on monotherapy was defined from the start of monotherapy period to the last dose of monotherapy treatment.|Week 8 to Week 18|efficacy population||days||95% Confidence Interval|Median
789613|NCT00866775|Secondary|Completion Rate During the 10 Weeks of Monotherapy|Monotherapy completion rate was defined as the proportion (%) of subjects entering the monotherapy period who completed the 10 weeks of monotherapy treatment.|Weeks 8 through 18|efficacy population||percentage of participants||95% Confidence Interval|Number
789614|NCT00866775|Secondary|Completion Rate|Subjects completing the study were determined as subjects who completed the 18 weeks of double-blind treatment.|Week 1 to Week 18|efficacy population||percentage of participants||95% Confidence Interval|Number
789615|NCT00866775|Secondary|Percentage of Subjects Seizure-free During the Last 4 Weeks on Eslicarbazepine Acetate Monotherapy.|Seizure-free subjects during the last four weeks of monotherapy were determined as subjects who had seizure assessments during the 4 weeks between Visits 8 and 9 (Weeks 15 through 18), and did not have any seizures.|Weeks 15 through 18|efficacy population||percentage of participants||95% Confidence Interval|Number
789616|NCT00866775|Secondary|Percentage of Subjects That Are Seizure-free During the 10-week Double-blind Monotherapy Treatment Period.|Seizure-free subjects during the monotherapy period were determined as subjects who had seizure assessments during the monotherapy period, and did not have any seizures in the 10 weeks between Visits 6 and 9 (Weeks 9 through 18). Subjects who discontinued during this period were considered not seizure-free even if they were seizure-free at the time of discontinuation, i.e., to be considered seizure-free, subjects must complete the 10-week period without any seizures.|Weeks 9 through 18|efficacy population||percentage of participants||95% Confidence Interval|Number
789694|NCT00860262|Secondary|Patients Achieving Systolic Blood Pressure Response at Week 2|SBP < 140 mmHg or reduction of >= 15 mmHg|baseline, week 2|FAS (LOCF)||participants|||Number
789695|NCT00860262|Secondary|Patients Achieving Systolic Blood Pressure Response at Week 1|Systolic Blood Pressure Response Control is defined as achieving SBP < 140 mmHg or a reduction of >= 15 mmHg|baseline, week 1|FAS (LOCF)||participants|||Number
789617|NCT00866775|Primary|Cumulative 112-day Exit Rate as Estimated by Kaplan-Meier Method|Cumulative exit rate was defined as the proportion of subjects meeting at least one of the five exit criteria over a 16-wk study period (start of Antiepilectic Drugs(AED) taper/conv.period (Wk 3 to end of double blind monotherapy period (Wk 18)):1.One episode of status epilepticus.2.One secondary general partial seizure (in subjects who did not have gen. seizures during 6 months prior to screening).3.A two fold increase in any consecutive 28 day seizure rate compared to the highest consecutive 28 day seizure rate during the 8 wk baseline period. 4.A two fold increase in any consecutive 2 day seizure rate compared to the highest consecutive 2 day seizure rate during the 8 wk baseline period. If the highest number of seizures in any consecutive 2 day period during the 8 wk baseline was 1 then 3 seizures in a consecutive 2 day period was required to exit.5.Worsening of seizures or increase in seizure frequency considered serious or requiring intervention as judged by the Investigator.|Week 3 to Week 18|efficacy population||proportion of participants||95% Confidence Interval|Number
789618|NCT00866788|Secondary|Terminal Half-Life (t1/2) of Omalizumab|Terminal Half-Life (t1/2) is the time required for the serum concentration of omalizumab to decrease by half in the final stage of its elimination.|Pre-dose and 2 hours post-dose on Days 0 and 3 of Week 0, Weeks 1, 2, 3, 4, 8, 12, 16 or early termination (up to Week 16)|Pharmacokinetic−Evaluable Population; Here, number of participants analyzed = participants with available data for this outcome measure.||days||Standard Deviation|Mean
789619|NCT00866788|Secondary|Area Under the Concentration-time Curve From Time of Dosing Extrapolated to Infinity (AUC-Inf)|AUCinf is the area under the concentration−time curve from time of dosing extrapolated to infinity. AUCinf was measured in microgram times day per milliliter (µg*day/mL). Only participants having complete profiles and completed the study were included in the analysis.|Pre-dose and 2 hours post-dose on Days 0 and 3 of Week 0, Weeks 1, 2, 3, 4, 8, 12, 16 or early termination (up to Week 16)|Pharmacokinetic−Evaluable Population; Here, number of participants analyzed = participants with available data for this outcome measure.||µg*day/mL||Standard Deviation|Mean
789620|NCT00866788|Secondary|Time to Maximum Concentration (Tmax) of Omalizumab|Tmax is the time to maximum concentration of omalizumab.|Pre-dose and 2 hours post-dose on Days 0 and 3 of Week 0, Weeks 1, 2, 3, 4, 8, 12, 16 or early termination (up to Week 16)|Pharmacokinetic−Evaluable Population; Here, number of participants analyzed = participants with available data for this outcome measure.||days||Standard Deviation|Mean
789621|NCT00866788|Secondary|Maximum Observed Concentration (Cmax) of Omalizumab|Cmax is the maximum (or peak) concentration of omalizumab in serum.|Pre-dose and 2 hours post-dose on Days 0 and 3 of Week 0, Weeks 1, 2, 3, 4, 8, 12, 16 or early termination (up to Week 16)|Pharmacokinetic−Evaluable Population included all randomized participants who received omalizumab and had pharmacokinetic data available. Here, number of participants analyzed = participants with available data for this outcome measure.||micrograms per milliliter (µg/mL)||Standard Deviation|Mean
789622|NCT00866788|Secondary|Number of Participants With Immunogenicity|Immunogenicity was measured by detection of anti-therapeutic antibodies (anti-omalizumab antibodies) using a fragment enzyme-linked immunosorbent assay (ELISA).|16 weeks|Safety-Evaluable Population||participants|||Number
789623|NCT00866788|Secondary|Number of Patients With Adverse Events by Severity|"The severity (i.e. intensity) of each Adverse Event (AE) was graded according to the following scale: Mild: Symptoms causing no or minimal interference with usual social and functional activities. Moderate: Symptoms causing greater than minimal interference with usual social and functional activities. Severe: Symptoms causing inability to perform usual social and functional activities.
Additional AE data is provided in the AE section below. The terms “severe” and “serious” are not synonymous. Severity refers to the intensity of an AE. A “Serious” AE is defined below."|"16 weeks overall (data reported separately for up to 4 weeks and Weeks 5 to 16)"|Safety-Evaluable Population, which included all randomized patients who received any study drug. number (n) equals (=) number of participants analyzed in the specified category.||participants|||Number
789624|NCT00866788|Secondary|Change in the Weekly Score for the Amount of Rescue Medication From Baseline to Week 4|Diphenhydramine 25mg was provided and used on an as-needed basis (maximum 3 times/day) as rescue medication. The weekly score for the amount of rescue medication is the sum of the daily scores for the amount of rescue medication used at each day in the week, and ranged from 0 to 21.|Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27)|Intent-to-Treat population (all randomized patients). The last observation carried forward value was used if a patient's Week 4 diary data were completely missing. One subject from the omalizumab 600-mg group did not have any post-baseline data and was excluded from the analysis.||Pills||Standard Deviation|Mean
789625|NCT00866788|Secondary|Change in the Weekly Score for Sleep Interference From Baseline to Week 4|The extent to which hives or itch interfered with participants’ sleep was recorded once daily in the patient diary using a scale from 0 (no interference) to 3 (substantial interference, waking often). The weekly score of sleep interference was the sum of the daily scores over the previous 7 days, and ranged from 0 to 21.|Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27)|Intent-to-Treat population (all randomized patients). The last observation carried forward value was used if a patient's Week 4 diary data were completely missing. One subject from the omalizumab 600-mg group did not have any post-baseline data and was excluded from the analysis.||scores on a scale||Standard Deviation|Mean
789626|NCT00866788|Secondary|Change in the Weekly Score for Number of Hives From Baseline to Week 4|The number of hives was recorded by participants twice daily (morning and evening) using a scale from 0 (no hives) to 3 (more than 12 hives). The weekly score of number of hives was the sum of the average daily scores over the previous 7 days, and ranged from 0 to 21.|Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27)|Intent-to-Treat population (all randomized patients). The last observation carried forward value was used if a patient's Week 4 diary data were completely missing. One subject from the omalizumab 600-mg group did not have any post-baseline data and was excluded from the analysis.||scores on a scale||Standard Deviation|Mean
789696|NCT00860262|Secondary|Patients Achieving Diastolic Blood Pressure Response at Week 2|DBP < 90 mmHg or reduction of >= 10 mmHg|baseline, week 2|FAS (LOCF)||participants|||Number
789697|NCT00860262|Secondary|Patients Achieving Diastolic Blood Pressure Response at Week 1|Diastolic Blood Pressure Response is defined as achieving DBP < 90 mmHg or a reduction of >= 10 mmHg|baseline, week 1|FAS (LOCF)||participants|||Number
789698|NCT00860262|Secondary|Patients Achieving Blood Pressure Control at Week 2|SBP < 140 mmHg and DBP < 90 mmHg|week 2|FAS (LOCF)||participants|||Number
789627|NCT00866788|Secondary|Change in the Weekly Pruritus Score From Baseline to Week 4|The pruritus (itch) score was recorded by participants twice daily (morning and evening) based on the severity of itch over the last 12 hours, using a scale from 0 (none) to 3 (severe). The weekly pruritus score was the sum of average daily pruritus scores over the previous 7 days. The range of the weekly score is 0-21.|Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27)|Intent-to-Treat population (all randomized patients). The last observation carried forward value was used if a patient's Week 4 diary data were completely missing. One subject from the omalizumab 600-mg group did not have any post-baseline data and was excluded from the analysis.||scores on a scale||Standard Deviation|Mean
789628|NCT00866788|Primary|Change in Urticaria Activity Score 7 (UAS7) From Baseline to Week 4|The UAS is a composite diary−recorded score, which is the sum of the numeric severity intensity ratings (0 = none to 3 = intense) for 1) the number of wheals (hives) and 2) the intensity of the pruritus (itch). The UAS7 is the sum of the daily average UAS (morning and evening values) for 7 days. The maximum UAS7 score is 42.|Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27)|Intent-to-Treat population (all randomized patients). The last observation carried forward value was used if a patient's Week 4 diary data were completely missing. One subject from the omalizumab 600-mg group did not have any post-baseline data and was excluded from the analysis.||scores on a scale||Standard Deviation|Mean
789629|NCT00866814|Secondary|Procedure Time|Procedure time will be defined as beginning when the investigator makes the initial incision and ending when the skin closure is completed.|Day of surgery|All enrolled patients.||minutes||Standard Deviation|Mean
789630|NCT00866814|Secondary|Quality of Life Will be Assessed at Baseline Through 1 Year Utilizing the Carolinas Comfort Scale Survey|"Mean Quality of Life scores at each study visit for the sensation of mesh, pain, and movement limitation components of the Carolinas Comfort Scale are reported. Patient responses are provided on a ordinal scale from 0-5 indicating increasing severity of symptoms with 0 representing no symptoms and 5 representing disabling symptoms. Sensation of mesh was not evaluable at baseline and therefore, scores are reported starting at 2 weeks post study procedure."|Baseline and post-surgery at week 2, month 6 and month 12|All enrolled patients with QOL scores at each visit.||units on a scale (0-5)||Standard Deviation|Mean
789631|NCT00866814|Secondary|Long-term Complications Will be Assessed by Evaluation of the Procedural and Device Related AEs Collected After 21 Days up to 1 Year.|In this study, a complication was defined as any adverse event that was assessed by the Investigator as either possibly or definitely related to the study procedure or the study device.|22 days post surgery through 1 year post surgery|All enrolled patients.||Complication events|||Number
789632|NCT00866814|Secondary|Short-term Complications Will be Assessed by Evaluation of the Procedural and Device Related AEs Collected From the Day After the Patient is Discharged From the Hospital Until 21 Days Post Procedure.|In this study, a complication was defined as any adverse event that was assessed by the Investigator as either possibly or definitely related to the study procedure or the study device.|Hospital discharge through 21 days post surgery|All enrolled patients.||Complication events|||Number
789633|NCT00866814|Secondary|Perioperative Complications Will be Assessed by Evaluation of the Procedural and Device Related Adverse Events (AEs) Collected From the Time Surgery is Initiated Until the Day the Patient is Discharged From the Hospital.|In this study, a complication was defined as any adverse event that was assessed by the Investigator as either possibly or definitely related to the study procedure or the study device.|From the time of surgery to hospital discharge, an average of 1-2 days|All enrolled patients.||Complication events|||Number
789634|NCT00866814|Primary|The Primary Endpoint is the Rate of Hernia Recurrence in Study Patients.|A recurrent hernia is a hernia, confirmed by the investigator at any point within the first year after surgery, in the same location as the hernia repaired in the index procedure.|1 year post surgery|All enrolled patients.||participants|||Number
789635|NCT00866905|Secondary|Disease Free Survival|Defined as the time between Day 1 Cycle 1, and date of first documented recurrence, initiation of additional chemotherapy, or death.|36 Months||||||
789636|NCT00866905|Secondary|Overall Survival|Overall survival (OS) determined as the time between day 1 cycle 1 to the date of death from any cause.|36 months||||||
789637|NCT00866905|Secondary|Absence of Grade-4 Non-hematologic Toxicity Excluding, Alopecia, Nausea, Vomiting and Bone Pain|Non hematologic treatment-related grade 4 toxicities measured according to RECIST v1.1|3 months|||participants|||Number
789638|NCT00866905|Primary|Pathologic Complete Response Rate (pCR)|Pathologic complete response (pCR) rate will be evaluated per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 following neoadjuvant treatment with six (21-day) cycles of ixabepilone and cyclophosphamide|6 months|||participants|||Number
789639|NCT00866918|Secondary|Overall Survival (OS)|OS - time from study entry to death.|At 3 years from study entry|Ineligible and inevaluable patients are excluded from analyses of OS.||Percentage of participants||95% Confidence Interval|Number
789640|NCT00866918|Secondary|Hematologic, Molecular, and Cytogenetic Remission Rate|Proportion of patients in hematologic, molecular, and cytogenetic remission at end of consolidation, course 3 and 4 are reported. Patients were determined to be in remission by all three criteria.|End of consolidation, course 3; up to 7 months (for Standard Risk) or end of consolidation, course 4; up to 9 months (for High Risk)|Patients who were ineligible (n=6), inevaluable (n=1), or who electively withdrew during Induction (n=4) were excluded.||Proportion of participants|||Number
789641|NCT00866918|Secondary|Hematologic Remission Rate|Proportion of patients in hematologic remission at end of consolidation, course 1 are reported.|End of consolidation, course 1: up to 5 months|Patients who were ineligible (n=6), inevaluable (n=1), or who electively withdrew during Induction (n=4) were excluded.||Proportion of participants|||Number
789642|NCT00866918|Primary|Event-free Survival (EFS)|EFS - time from study entry until failure to achieve complete remission during consolidation, relapse, or death. For further clarification see definitions provided in the protocol.|At 3 years from study entry|Ineligible and inevaluable patients are excluded from analyses of EFS.||Percentage of participants||95% Confidence Interval|Number
789699|NCT00860262|Secondary|Patients Achieving Blood Pressure Control at Week 1|Blood Pressure Control is defined as achieving SBP< 140 mmHg and DBP < 90mmHg|week 1|FAS (LOCF)||participants|||Number
789700|NCT00860262|Secondary|Patients Achieving Diastolic Blood Pressure Control at Week 2|DBP < 90 mmHg|week 2|FAS (LOCF)||participants|||Number
789643|NCT00867009|Secondary|The Percentage of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) (Disease Control Rate [DCR])|The DCR is presented as percentage (%) and is the number of participants with a best tumor response of CR, PR, or SD divided by the number of participants in the protocol qualified (PQ) population, then multiplied by 100. Best tumor response of CR, PR, or SD was determined from the sequence of tumor response assessments. Tumor response was assessed using RECIST criteria. CR=disappearance of all target lesions; PR=30% decrease in sum of longest diameter of target lesions; SD=small changes that do not meet above criteria.|From start of treatment until documented best tumor response (up to 18.9 months)|Outcome measure was assessed using the Protocol Qualified (PQ) population.||percentage of participants|||Number
789644|NCT00867009|Secondary|The Percentage of Participants Still Living at One Year (One Year Survival Rate)|The one year survival rate is presented as percentage (%) of participants still living at one year and is the number of participants that are still alive at one year divided by the number of participants in the protocol qualified (PQ) population, which is then multiplied by 100.|One year|Outcome measure was assessed using the Protocol Qualified (PQ) population.||percentage of participants|||Number
789645|NCT00867009|Secondary|Progression-free Survival (PFS)|PFS is measured from study entry until disease progression, death or date of last contact. Progressive disease (PD) was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD = 20% increase in sum of longest diameter of target lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. For participants not known to have died or have had objective PD as of the data cutoff date, PFS was censored at the date of the last objective progression-free disease assessment.|From start of treatment until documented disease progression or death from any cause (up to 18.9 months)|Outcome measure was assessed using the Protocol Qualified (PQ) population.||months||Full Range|Median
789646|NCT00867009|Primary|Percentage of Participants With a Tumor Response (Objective Tumor Response Rate)|Response was assessed using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions. Tumor response is presented as a percentage (%) and is the number of participants with a CR plus PR divided by the number of participants in the protocol qualified (PQ) population, then multiplied by 100.|From start of treatment until documented best response. (up to 18.9 months)|Outcome measure was assessed using the Protocol Qualified (PQ) population.||percentage of participants|||Number
789647|NCT00867035|Secondary|Percentage of Sulfide-producing Black Colonies Out of Total Viable Count(TVC) on Anaerobe Agar Containing Lead Acetate||1 week|ITT||percentage black colonies||Standard Deviation|Mean
789648|NCT00867035|Secondary|Number of Bacteria on Tongue at 1 Week|Total viable count(TVC) in colony forming units(CFU) on anaerobe agar|1 week|ITT||colony forming units (CFU)||Standard Deviation|Mean
789649|NCT00867035|Secondary|Concentration of Methyl Mercaptan (MM) in Mouth Air at 1 Week|Using portable gas chromatograph|1 week|ITT||parts per billion||Standard Deviation|Mean
789650|NCT00867035|Secondary|Concentration of Methyl Mercaptan (MM) in Mouth Air at 4 Hours|Using portable gas chromatograph|4 hours|ITT||parts per billion||Standard Deviation|Mean
789651|NCT00867035|Secondary|Concentration of Methyl Mercaptan (MM) in Mouth Air at 2 Hours|Using portable gas chromatograph|2 hours|||parts per billion||Standard Deviation|Mean
789652|NCT00867035|Secondary|Concentration of Methyl Mercaptan (MM) in Mouth Air at 1 Hour|Using portable gas chromatograph|1 hour|ITT||parts per billion (ppb)||Standard Deviation|Mean
789653|NCT00867035|Secondary|Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 1 Week|Using portable gas chromatograph|1 week|ITT||parts per billion (ppb)||Standard Deviation|Mean
789654|NCT00867035|Secondary|Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 4 Hours|Using portable gas chromatograph|4 hours|ITT||parts per billion (ppb)||Standard Deviation|Mean
789655|NCT00867035|Secondary|Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 2 Hours|Using portable gas chromatograph|2hr|ITT||parts per billion (ppb)||Standard Deviation|Mean
789656|NCT00867035|Secondary|Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 1 Hour|Using portable gas chromatograph|1hr|ITT||parts per billion (ppb)||Standard Deviation|Mean
789657|NCT00867035|Primary|Percentage of Participants With Rosenberg Score at Indicated Time Points|2 investigators are trained to evaluate smell using the Rosenberg scale which measures foul smelling breath. The Rosenberg scale is validated and is scored 0-5 with 0= no bad breath, 5=worst bad breath. A score of 2 is the threshold at which bad breath is determined.|baseline, 1 hour, 2 hours, 4 hours, 1 week|two judges score breath odor by Rosenberg scale 0 to 5. Score of 2 is threshold for malodor. participants randomly assigned, ITT.||percentage of participants|||Number
789658|NCT00867087|Secondary|Percentage of Participants With Treatment-Emergent Adverse Events (AEs) During Inotuzumab Ozogamicin Plus Rituximab Treatment|An AE was any untoward, undesired, or unplanned event in the form of signs, symptoms, disease, or laboratory/physiologic observations occurring in a participant given a test article or in a clinical study; the event may not necessarily have had a causal relationship with the treatment. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; cancer. Treatment-emergent AEs were AEs that emerged after the first dose of the study treatment during the treatment period that were absent pre-treatment, or worsened during the treatment period relative to the pre-treatment state. The severity of all AEs was graded by the investigator using the NCI Common Terminology Criteria for AE Version 3.0 (CTCAE v3.0).|Treatment emergent AEs were collected from time of first dose to end of trial visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs were collected from informed consent until end of trial visit (up to 6 months).|Safety population Summary excludes events occurring after start of consolidation treatment.||Percentage of Participants|||Number
789701|NCT00860262|Secondary|Patients Achieving Diastolic Blood Pressure Control at Week 1|Diastolic Blood Pressure Control is defined as achieving DBP < 90mmHg|week 1|Full analysis set, imputation method used was last observation carried forward (LOCF).||participants|||Number
789702|NCT00860262|Secondary|Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 1|Overall mean reduction from a common mean baseline in DBP|baseline and week 1|Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement.||mmHg (millimeters of mercury)||Standard Error|Least Squares Mean
789659|NCT00867087|Secondary|Percentage of Participants With Any Grade 3/4 Laboratory Abnormality During Therapy|The following parameters were analyzed for serum chemistry; blood urea nitrogen (or urea), creatinine, glucose, calcium, sodium, potassium, phosphorus, lactate dehydrogenase, aspartate aminotransferase, alanine aminotransferase, total bilirubin (and direct bilirubin, if total bilirubin was elevated), alkaline phosphatase, uric acid (or urate), albumin and total protein. The following parameters were analyzed for hematology; lymphocytes, basophils, eosinophils, erythrocytes, hematocrit, hemoglobin, leukocytes, monocytes, neutrophils, platelets, prothrombin international normalized ratio, prothrombin time, fibrinogen, and activated partial thromboplastin time. Laboratory test results were graded using the NCI Common Terminology Criteria for Adverse Events, version 3.0 (CTCAE v3.0).|Within 3 days prior each dose of test article, on Day -2, 1, 8, and 15 of Cycles 1 to 3, 2 to 3 weeks after Cycle 3, at the end-of-treatment visit, and every 3 to 6 months during long-term follow-up (up to 2 years).|Safety population||Percentage of Participants|||Number
789660|NCT00867087|Secondary|Overall Survival (OS)|OS was the time (in months) from the date of randomization to the date of death, and censored at the date of last contact if no death occurred.|From randomization until the date of death, or the date of last contact if no death occurred (up to 2 years).|ITT population||Months||95% Confidence Interval|Median
789661|NCT00867087|Secondary|Percentage of Participants With a CR After 3 Cycles of Inotuzumab Ozogamicin Plus Rituximab Therapy|CR: complete disappearance of all detectable clinical & radiographic evidence of disease & disease-related symptoms; lymph nodes & nodal masses regressed to normal size (≤ 1.5 cm in their greatest transverse diameter for nodes > 1.5 cm before therapy); spleen and other organs (if enlarged prior to therapy) regressed in size & spleen not palpable on physical examination; repeat bone marrow infiltrate clear. Response includes confirmed CR and unconfirmed CR.|From the first dose to approximately 2 to 3 weeks after 3 cycles of inotuzumab ozogamicin plus rituximab (induction) therapy (up to 12 weeks).|ITT population||Percentage of Participants||95% Confidence Interval|Number
789662|NCT00867087|Secondary|Event-Free Survival (EFS) After aSCT|EFS was the time (in months) from the date of aSCT to the earliest date of progression, relapse after CR, death from any cause without progression, initiation of a new treatment for the lymphoma or was censored at the date of the last tumor assessment.|From the completion of aSCT through 2 year long-term follow-up period, including but not limited to planned assessments scheduled every 3 to 6 months.|ITT population. Only participants who underwent aSCT were included in the analysis.||Months||95% Confidence Interval|Median
789663|NCT00867087|Secondary|Percentage of Participants Who Underwent Autologous Stem Cell Transplant (aSCT)|Participants underwent high dose chemotherapy and aSCT. In order to proceed to aSCT, participants were required to achieve CR or PR and successful collection of PSBC (≥ 2.0 x 10^6 CD34+ cells/kg collected after 3 cycles).|A minimum of 4 weeks and a maximum of 8 weeks after the last cycle of inotuzumab ozogamicin plus rituximab (induction) therapy (up to 26 weeks).|ITT population||Percentage of Participants||95% Confidence Interval|Number
789664|NCT00867087|Secondary|Percentage of Participants With Successful G-CSF Mobilization of PBSC|Successful mobilization of PBSC was defined as ≥ 2 x 10^6 CD34+ cells/kg collected after 3 cycles of inotuzumab ozogamicin plus rituximab therapy.|From the first dose to approximately 2 to 3 weeks after up to 6 cycles of inotuzumab ozogamicin plus rituximab (induction) therapy (up to 21 weeks).|ITT population||Percentage of Participants||95% Confidence Interval|Number
789665|NCT00867087|Secondary|Percentage of Participants With a Response of CR or PR and Who Had Successful Granulocyte Colony Stimulating Factor (G-CSF) Mobilization of Peripheral Blood Stem Cells (PBSCs) Overall and After 3 Cycles of Inotuzumab Ozogamicin Plus Rituximab Therapy|Successful mobilization of PBSC: ≥ 2 x 10^6 cluster of differentiation (CD) 34+ cells per kilogram (cells/kg) after 3 cycles. CR: no detectable clinical & radiographic evidence of disease/disease-related symptoms; lymph nodes/nodal masses regressed to normal size (≤ 1.5 cm in greatest transverse diameter for nodes > 1.5 cm pre-therapy); spleen & other organs (if enlarged pre-therapy) regressed in size & spleen not palpable on physical examination; repeat bone marrow infiltrate clear. PR: ≥ 50% decrease in SPD of 6 largest dominant nodes/nodal masses; no increase in size of other nodes, liver, or spleen; splenic & hepatic nodules regressed by ≥ 50% in SPD; involvement of other organs usually assessable & no measurable disease present; no new sites of disease. Participants achieving CR, but with persistent morphologic bone marrow involvement or no bone marrow assessment post treatment were partial responders. Response includes confirmed CR/PR and unconfirmed CR/PR.|From the first dose to approximately 2 to 3 weeks after 3 cycles of inotuzumab ozogamicin plus rituximab (induction) therapy (up to 12 weeks) and up to approximately 2 to 3 weeks after 6 cycles (up to 21 weeks).|ITT population||Percentage of Participants||95% Confidence Interval|Number
789666|NCT00867087|Secondary|Kaplan-Meier Estimate of PFS 2 Years After Inotuzumab Ozogamicin Plus Rituximab Therapy|PFS; time from date of randomization to earliest date of progression, relapse after CR, death from any cause without progression, start of new treatment for the lymphoma excluding treatments/procedures for consolidation therapy in this protocol, or censored at date of last tumor assessment. Progression: abnormal lymph nodes (long axis > 1.5 cm or long axis 1.1 to 1.5 cm and short axis > 1.0 cm); appearance of any new lesion > 1.5 cm in any axis during or at end of treatment; ≥ 50% increase from nadir in SPD of any previously involved nodes, in a single involved node, or in the size of other lesions; ≥ 50% increase in longest diameter of any single previously identified node > 1.0 cm in short axis.|2 years after the first dose of inotuzumab ozogamicin|ITT population||Percentage of Participants||95% Confidence Interval|Number
789667|NCT00867087|Secondary|Kaplan-Meier Estimate of Progression Free Survival (PFS) 6 Months After Inotuzumab Ozogamicin Plus Rituximab Therapy|PFS; time from date of randomization to earliest date of progression, relapse after CR, death from any cause without progression, start of new treatment for the lymphoma excluding treatments/procedures for consolidation therapy in this protocol, or censored at date of last tumor assessment. Progression: abnormal lymph nodes (long axis > 1.5 cm or long axis 1.1 to 1.5 cm and short axis > 1.0 cm); appearance of any new lesion > 1.5 cm in any axis during or at end of treatment; ≥ 50% increase from nadir in SPD of any previously involved nodes, in a single involved node, or in the size of other lesions; ≥ 50% increase in longest diameter of any single previously identified node > 1.0 cm in short axis.|6 months after the first dose of inotuzumab ozogamicin|ITT population||Percentage of Participants||95% Confidence Interval|Number
789733|NCT00867139|Secondary|Number of Participants With Viral Resistance as a Function of Drug Exposure|Viral resistance was assessed within 28 days after drug administration by detecting resistance-conferring mutation genes and compared to the value at baseline.|28 days|One open-labeled patient withdrew on day 5.||Number of participants|||Number
789668|NCT00867087|Primary|Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) After 3 Cycles of Inotuzumab Ozogamicin Plus Rituximab Therapy|Response criteria based on National Cancer Institute (NCI) International Response Criteria for non-Hodgkin’s lymphoma. CR: no detectable clinical & radiographic evidence of disease/disease-related symptoms; lymph nodes/nodal masses regressed to normal size (less than or equal to [≤] 1.5 cm in greatest transverse diameter for nodes greater than [>] 1.5 cm pre-therapy); spleen & other organs (if enlarged pre-therapy) regressed in size & spleen not palpable on physical examination; repeat bone marrow infiltrate clear. PR: > or equal to (≥) 50% decrease in sum of product diameters (SPD) of 6 largest dominant nodes/nodal masses; no increase in size of other nodes, liver, or spleen; splenic & hepatic nodules regressed by ≥ 50% in SPD; involvement of other organs usually assessable & no measurable disease present; no new sites of disease. Participants achieving CR, but with persistent morphologic bone marrow involvement or no bone marrow assessment after treatment were partial responders.|Up to 2 years (9 weeks of 3 21-day cycles and every 3 to 6 months during the long-term follow-up period)|Intention-to-treat (ITT) population - included all participants enrolled into the study. Response includes confirmed CR/PR and unconfirmed CR/PR.||Percentage of Participants||95% Confidence Interval|Number
789669|NCT00860158|Secondary|To Estimate Safety and Tolerability of LHRH Plus Dasatinib||18 months||||||
789670|NCT00860158|Secondary|To Evaluate the Impact of Dasatinib Plus LHRH on Expression of Selected Biomarkers||18 months||||||
789671|NCT00860158|Secondary|To Estimate Progression Free Survival||18 months||||||
789672|NCT00860158|Secondary|To Estimate PSA Response Rate||18 months||||||
789673|NCT00860158|Secondary|To Estimate Partial Pathologic Responses (pPR)||18 months||||||
789674|NCT00860158|Primary|To Estimate the Pathologic Complete Response (pCR) Rate||18 months|No participants were analyzed for pCR due to study termination|||||
789675|NCT00860249|Primary|Completion of CRC Screening|What would have been reported as this Outcome Measure is the number of participants who completed screening. We planned to review electronic health records of participants 6 months post randomization to look for either: (1) note in free text MD note documenting receipt of one form of colorectal cancer (CRC) screening during study period or (2)lab results from fecal occult blood test, sigmoidoscopy, or colonoscopy. Screening completion equaled presence of a lab result or physician note in chart. No patient charts were reviewed due to low accrual.|6 months from initial contact|Although 60 individuals were randomized to condition, the trial was halted prior to primary or secondary outcome chart reviews. Hence there are no results to report.||participants|||Number
789676|NCT00860249|Secondary|The Secondary Outcome for the Study is the Time to Screening Completion.|This Outcome Measure would have reported the length of time, measured in days, that occurred between the date of randomization and the completed screening date. We planned to review the electronic health records of participants 6 months post randomization to look for either: (1)note in free text MD note documenting receipt of one form of CRC screening during study period or (2)lab results from fecal occult blood test, sigmoidoscopy, or colonoscopy. Screening completion equaled presence of a lab result or physician note in chart. No patient charts were reviewed due to low accrual.|6 months after randomization|Although 60 individuals were randomized to condition, the trial was halted prior to primary or secondary outcome chart reviews. Hence there are no results to report.||participants|||Number
789677|NCT00860262|Secondary|Patients Achieving Normal Blood Pressure Response at Week 8|Optimal: SBP<120 and DBP< 80; Normal: 120<=SBP<130 and 80<= DBP<85; High normal: 130<=SBP<140 and 85<=DBP<90; High: SBP>=140 or DBP>=90|week 8|FAS (LOCF)||participants|||Number
789678|NCT00860262|Secondary|Patients Achieving Normal Blood Pressure Response at Week 6|Optimal: SBP<120 and DBP< 80; Normal: 120<=SBP<130 and 80<= DBP<85; High normal: 130<=SBP<140 and 85<=DBP<90; High: SBP>=140 or DBP>=90|week 6|FAS (LOCF)||participants|||Number
789679|NCT00860262|Secondary|Patients Achieving Normal Blood Pressure Response at Week 4|Optimal: SBP<120 and DBP< 80; Normal: 120<=SBP<130 and 80<= DBP<85; High normal: 130<=SBP<140 and 85<=DBP<90; High: SBP>=140 or DBP>=90|week 4|FAS (LOCF)||participants|||Number
789680|NCT00860262|Secondary|Patients Achieving Systolic Blood Pressure Response at Week 8|SBP < 140 mmHg or reduction of >= 15 mmHg|baseline, week 8|FAS (LOCF)||participants|||Number
789681|NCT00860262|Secondary|Patients Achieving Systolic Blood Pressure Response at Week 6|SBP < 140 mmHg or reduction of >= 15 mmHg|baseline, week 6|FAS (LOCF)||participants|||Number
789682|NCT00860262|Secondary|Patients Achieving Systolic Blood Pressure Response at Week 4|SBP < 140 mmHg or reduction of >= 15 mmHg|baseline, week 4|FAS (LOCF)||participants|||Number
789683|NCT00860262|Secondary|Patients Achieving Diastolic Blood Pressure Response at Week 8|DBP < 90 mmHg or reduction of >= 10 mmHg|baseline, week 8|FAS (LOCF)||participants|||Number
789684|NCT00860262|Secondary|Patients Achieving Diastolic Blood Pressure Response at Week 6|DBP < 90 mmHg or reduction of >= 10 mmHg|baseline, week 6|FAS (LOCF)||participants|||Number
789685|NCT00860262|Secondary|Patients Achieving Diastolic Blood Pressure Response at Week 4|DBP < 90 mmHg or reduction of >= 10 mmHg|baseline, week 4|FAS (LOCF)||participants|||Number
789686|NCT00860262|Secondary|Patients Achieving Blood Pressure Control at Week 8|SBP < 140 mmHg and DBP < 90 mmHg|week 8|FAS (LOCF)||participants|||Number
789687|NCT00860262|Secondary|Patients Achieving Blood Pressure Control at Week 6|SBP < 140 mmHg and DBP < 90 mmHg|week 6|FAS (LOCF)||participants|||Number
789688|NCT00860262|Secondary|Patients Achieving Blood Pressure Control at Week 4|SBP < 140 mmHg and DBP < 90 mmHg|week 4|FAS (LOCF)||participants|||Number
789689|NCT00860262|Secondary|Patients Achieving Diastolic Blood Pressure Control at Week 8|DBP < 90 mmHg|week 8|FAS (LOCF)||participants|||Number
789690|NCT00860262|Secondary|Patients Achieving Diastolic Blood Pressure Control at Week 6|DBP < 90 mmHg|week 6|FAS (LOCF)||participants|||Number
789691|NCT00860262|Secondary|Patients Achieving Diastolic Blood Pressure Control at Week 4|DBP < 90 mmHg|week 4|FAS (LOCF)||participants|||Number
789692|NCT00860262|Secondary|Number of Patients Achieving Various Blood Pressure Response Levels at Week 2|Optimal: SBP<120 and DBP< 80; Normal: 120<=SBP<130 and 80<= DBP<85; High normal: 130<=SBP<140 and 85<=DBP<90; High: SBP>=140 or DBP>=90|week 2|FAS (LOCF)||participants|||Number
789693|NCT00860262|Secondary|Number of Patients Achieving Various Blood Pressure Response Levels at Week 1|Optimal: SBP<120 and DBP< 80; Normal: 120<=SBP<130 and 80<= DBP<85; High normal: 130<=SBP<140 and 85<=DBP<90; High: SBP>=140 or DBP>=90|week 1|FAS (LOCF)||participants|||Number
789708|NCT00860262|Secondary|Change From Baseline in Trough Seated Systolic Blood Pressure at Week 2|Overall mean reduction from a common mean baseline in SBP|baseline and week 2|Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement.||mmHg (millimeters of mercury)||Standard Error|Least Squares Mean
789709|NCT00860262|Secondary|Change From Baseline in Trough Seated Systolic Blood Pressure at Week 4|Overall mean reduction from a common mean baseline in SBP|baseline and week 4|Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement.||mmHg (millimeters of mercury)||Standard Error|Least Squares Mean
789710|NCT00860262|Secondary|Change From Baseline in Trough Seated Systolic Blood Pressure at Week 6|Overall mean reduction from a common mean baseline in SBP|baseline and week 6|Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement.||mmHg (millimeters of mercury)||Standard Error|Least Squares Mean
789711|NCT00860262|Primary|Change From Baseline in Trough Seated Systolic Blood Pressure (SBP) at Week 8|Overall mean reduction from a common mean baseline in SBP|baseline and week 8|Full analysis set (FAS) included all randomised patients who had at least one seated trough cuff SBP following administration of study drug.||mmHg (millimeters of mercury)||Standard Error|Least Squares Mean
789712|NCT00860314|Secondary|Number of Participants Succesfully Cardioverted With First Shock in Each Electrode Position|Number of participants successfully cardioverted to normal sinus rhythm with one shock of 50 Joules.|30 seconds after cardioversion|||participants|||Number
789713|NCT00860314|Secondary|Mean Energy Requirement for Successful Cardioversion|Overall energy in the mean (number of joules) necessary for successful cardioversion of all patients per group.|30 seconds after cardioversion|||Joules||Standard Deviation|Mean
789714|NCT00860314|Primary|Number of Successfully Cardioverted Participants for Each Electrode Position|After restoration of normal sinus rhythm for 30 seconds and longer by electrical countershock a cardioversion is counted as successful.|30 seconds after cardioversion|||participants|||Number
789715|NCT00860314|Secondary|Mean Number of Cardioversion Shocks||30 seconds after cardioversion|||Shocks||Standard Deviation|Mean
789716|NCT00860405|Other Pre-specified|Acute Renal Failure (ARF)|Acute renal failure was defined as a two fold increase in serum creatinine concentration over the value at baseline at any time after baseline.|From baseline until 2nd postop morning.|Safety Population (SAF) = All randomized patients treated with study drug.||Participants|||Number
789717|NCT00860405|Other Pre-specified|Mortality|Mortality was reported for the time period from screening until the end of follow-up.|From screening to end of follow-up|Safety Population (SAF) = All randomized patients treated with study drug||Participants|||Number
789718|NCT00860405|Other Pre-specified|Length of Stay on the Intensive Care Unit (ICU)|Length of stay (number of days) on the intensive care unit (ICU).|From admission to ICU until discharge from ICU|Safety Population (SAF) = All randomized patients treated with study drug.||Days||Inter-Quartile Range|Median
789719|NCT00860405|Other Pre-specified|Calculated Perioperative Red Blood Cell (RBC) Loss|"Calculated perioperative RBC loss = Predicted blood volume1 × (hematocrit [baseline] – hematocrit [2nd postop morning]) + transfused RBC volume2;
Predicted blood volume (mL) = 80 × body weight (kg)
Transfused RBC volume = 0.7 × infused packed RBC"|2 days|Safety Population (SAF) = All randomized patients treated with study drug.||ml/kg||Standard Deviation|Mean
789720|NCT00860405|Secondary|Fluid Balance|Balance of total fluid input and total fluid output|2 days|Per-protocol population (PP) = All patients in the ITT set without any major protocol violation.||ml/kg||Standard Deviation|Mean
789721|NCT00860405|Secondary|Fluid Output|Quantity of total fluids excreted or lost from beginning of anaesthesia until 2nd postop morning|2 days|Per-protocol population (PP) = All patients in the ITT set without any major protocol violation.||ml/kg||Standard Deviation|Mean
789722|NCT00860405|Secondary|Fluid Input|Quantity of total fluids administered from beginning of anaesthesia until 2nd postop morning|2 days|Per-protocol population (PP) = All patients in the ITT set without any major protocol violation||ml/kg||Standard Deviation|Mean
789723|NCT00860405|Secondary|Mean Arterial Pressure (MAP)|Mean arterial pressure (MAP) from beginning of anaesthesia (baseline) until arrival on intensive care unit (ICU)|Beginning of anaesthesia (baseline) until arrival on intensive care unit (ICU)|Per-protocol population (PP) = All patients in the ITT set without any major protocol violation||mm Hg||Standard Deviation|Mean
789724|NCT00860405|Primary|Total Volume of Colloid Solution Required Intraoperatively|Total volume of study drug plus rescue colloid, if applicable|Day 1 (intraoperatively)|Per-protocol population (PP) = All patients in the Intention-to-treat (ITT) set without any major protocol violation.||ml/kg||Standard Deviation|Mean
789725|NCT00867139|Secondary|Pharmacokinetics (AUC0-last) of TCAD|Only 5 patients had partial pharmacokinetic (PK) data available. Plasma concentration of oseltamivir was measured at several time points in one patient receiving neuraminidase inhibitor monotherapy. Plasma concentration of oseltamivir, amantadine, and ribavirin were measured at several time points in four patients receiving TCAD therapy. Area under the time-concentration curve up to the last measured time point (AUC0-last) was calculated from the plasma concentration-time profiles by non-compartmental analysis.|5 days|||ng*hr/mL||Standard Deviation|Mean
789726|NCT00867139|Secondary|Number of Deaths||58 days|||participants|||Number
789727|NCT00867139|Secondary|Number of Participants With Intubations||58 days|||participants|||Number
789728|NCT00867139|Secondary|Number of Participants With ICU Admissions|The number of participants with ICU admissions was evaluated.|baseline and up to 58 days|||participants|||Number
789729|NCT00867139|Secondary|Days on Supplemental Oxygen||58 days|One open-labeled TCAD patient withdrew on day 5.||days||Standard Deviation|Mean
789730|NCT00867139|Secondary|Duration of Hospitalization||from baseline up to 58 days|One open-labeled patient withdrew the study on day 5||days||Standard Deviation|Mean
789731|NCT00867139|Secondary|Frequency of Confirmed Pneumonia||58 days|||participants|||Number
789732|NCT00867139|Secondary|Duration of Symptoms|"Calculated as the number of days (mean) any persistent symptom lasted per patient as listed below.
overall health, short of breath, chills, cough, diarrhea, ear pain, fatigue, fever, headache, hoarseness, muscle ache, phlegm, runny nose, sinus congestion, sneezing, sore throat, watery eyes, wheezing"|from baseline up to 28 days|one open labeled patient withdrew on day 5.||days||Standard Deviation|Mean
789735|NCT00867139|Secondary|Number of Participants With Viral Load Decrease as a Function of Time|Viral loads were measured by quantitative Polymerase Chain Reaction (PCR) on day 1, 3, 5, 7, 9, 15, 20 and 28, if applicable.|baseline and 28 days|Three patients could not get viral load at baseline.||number of participants|||Number
789736|NCT00867139|Primary|Number of Participants With Adverse Events (AEs), Drug Specific AEs or AEs Resulting in Treatment Interruption|"Abnormal lab data or newly appeared symptoms & signs were considered as AEs.
Examined lab data:
Blood cell count (WBC, differential count, Red Blood Cell (RBC), Hemoglobin, Hematocrit, Mean Corpuscular Volume (MCV), Mean Corpuscular Hemoglobin Concentration (MCHC), platelets), Chemistry (Cl, bicarbonate (HCO3), K, Na), Renal function test (BUN, Creatinine, Creatinine clearance), Liver function test (AST, Alanine aminotransferase(ALT), T.Bil, gamma-glutamyltransferase)"|30 days after the final dose of study drug|||number of participants with AEs|||Number
789737|NCT00867165|Secondary|Percentage Change From Baseline in Lathosterol at Week 12|Plasma lathosterol measured at baseline and after 12 weeks of study drug administration.|Baseline and Week 12|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
789738|NCT00867165|Secondary|Percentage Change From Baseline in Lathosterol at Week 8|Plasma lathosterol measured at baseline and after 8 weeks of study drug administration.|Baseline and Week 8|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
789739|NCT00867165|Secondary|Percentage Change From Baseline in Lathosterol at Week 4|Plasma lathosterol measured at baseline and after 4 weeks of study drug administration.|Baseline and Week 4|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
789740|NCT00867165|Secondary|Percentage Change From Baseline in Lathosterol at Week 2|Plasma lathosterol measured at baseline and after 2 weeks of study drug administration.|Baseline and Week 2|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
789741|NCT00867165|Secondary|Percentage Change From Baseline in Cholestanol at Week 12|Plasma cholestanol measured at baseline and after 12 weeks of study drug administration.|Baseline and Week 12|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
789742|NCT00867165|Secondary|Percentage Change From Baseline in Cholestanol at Week 8|Plasma cholestanol measured at baseline and after 8 weeks of study drug administration.|Baseline and Week 8|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
789743|NCT00867165|Secondary|Percentage Change From Baseline in Cholestanol at Week 4|Plasma cholestanol measured at baseline and after 4 weeks of study drug administration.|Baseline and Week 4|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
789744|NCT00867165|Secondary|Percentage Change From Baseline in Cholestanol at Week 2|Plasma cholestanol measured at baseline and after 2 weeks of study drug administration.|Baseline and Week 2|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
789745|NCT00867165|Secondary|Percentage Change From Baseline in Campesterol at Week 12|Plasma campesterol measured at baseline and after 12 weeks of study drug administration.|Baseline and Week 12|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
789746|NCT00867165|Secondary|Percentage Change From Baseline in Campesterol at Week 8|Plasma campesterol measured at baseline and after 8 weeks of study drug administration.|Baseline and Week 8|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
789747|NCT00867165|Secondary|Percentage Change From Baseline in Campesterol at Week 4|Plasma campesterol measured at baseline and after 4 weeks of study drug administration.|Baseline and Week 4|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
789748|NCT00867165|Secondary|Percentage Change From Baseline in Campesterol at Week 2|Plasma campesterol measured at baseline and after 2 weeks of study drug administration.|Baseline and Week 2|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
789749|NCT00867165|Secondary|Percentage Change From Baseline in Sitosterol at Week 12|Plasma sitosterol measured at baseline and after 12 weeks of study drug administration.|Baseline and Week 12|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
789750|NCT00867165|Secondary|Percentage Change From Baseline in Sitosterol at Week 8|Plasma sitosterol measured at baseline and after 8 weeks of study drug administration.|Baseline and Week 8|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
789751|NCT00867165|Secondary|Percentage Change From Baseline in Sitosterol at Week 4|Plasma sitosterol measured at baseline and after 4 weeks of study drug administration.|Baseline and Week 4|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
789752|NCT00867165|Secondary|Percent Change From Baseline in Sitosterol at Week 2|Plasma sitosterol measured at baseline and after 2 weeks of study drug administration.|Baseline and Week 2|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
789753|NCT00867165|Secondary|Percentage Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 12|Plasma hs-CRP measured at baseline and after 12 weeks of study drug administration.|Baseline and Week 12|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
789754|NCT00867165|Secondary|Percentage Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 4|Plasma hs-CRP measured at baseline and after 4 weeks of study drug administration.|Baseline and Week 4|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
789755|NCT00867165|Secondary|Percentage Change From Baseline in Apo B:Apo A-I Ratio at Week 12|Serum Apo B:Apo A-I Ratio calculated at baseline and after 12 weeks of study drug administration|Baseline and Week 12|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
789756|NCT00867165|Secondary|Percentage Change From Baseline in LDL-C:HDL-C Ratio at Week 12|Serum LDL-C:HDL-C Ratio calculated at baseline and after 12 weeks of study drug administration.|Baseline and Week 12|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
789757|NCT00867165|Secondary|Percentage Change From Baseline in LDL-C:HDL-C Ratio at Week 8|Serum LDL-C:HDL-C Ratio calculated at baseline and after 8 weeks of study drug administration.|Baseline and Week 8|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
789758|NCT00867165|Secondary|Percentage Change From Baseline in LDL-C:HDL-C Ratio at Week 4|Serum LDL-C:HDL-C Ratio calculated at baseline and after 4 weeks of study drug administration.|Baseline and Week 4|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
789759|NCT00867165|Secondary|Percentage Change From Baseline in LDL-C:HDL-C Ratio at Week 2|Serum LDL-C:HDL-C Ratio calculated at baseline and after 2 weeks of study drug administration.|Baseline and Week 2|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
789760|NCT00867165|Secondary|Percentage Change From Baseline in TC:HDL-C Ratio at Week 12|Serum TC:HDL-C Ratio calculated at baseline and after 12 weeks of study drug administration.|Baseline and Week 12|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
789761|NCT00867165|Secondary|Percentage Change From Baseline in TC:HDL-C Ratio at Week 8|Serum TC:HDL-C Ratio calculated at baseline and after 8 weeks of study drug administration.|Baseline and Week 8|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
789762|NCT00867165|Secondary|Percentage Change From Baseline in TC:HDL-C Ratio at Week 4|Serum TC:HDL-C Ratio calculated at baseline and after 4 weeks of study drug administration.|Baseline and Week 4|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
789763|NCT00867165|Secondary|Percentage Change From Baseline in TC:HDL-C Ratio at Week 2|Serum TC:HDL-C Ratio calculated at baseline and after 2 weeks of study drug administration.|Baseline and Week 2|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
789764|NCT00867165|Secondary|Percentage Change From Baseline in Apolipoprotein A-I (Apo A-I) at Week 12|Serum Apo A-I levels measured at baseline and after 12 weeks of study drug administration.|Baseline and Week 12|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
789765|NCT00867165|Secondary|Percentage Change From Baseline in TG at Week 8|Serum TG levels measured using enzymatic methods at baseline and after 8 weeks of study drug administration.|Baseline and Week 8|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
789766|NCT00867165|Secondary|Percentage Change From Baseline in TG at Week 4|Serum TG levels measured using enzymatic methods at baseline and after 4 weeks of study drug administration.|Baseline and Week 4|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
789767|NCT00867165|Secondary|Percentage Change From Baseline in TG at Week 2|Serum TG levels measured using enzymatic methods at baseline and after 2 weeks of study drug administration.|Baseline and Week 2|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
789768|NCT00867165|Secondary|Percentage Change From Baseline in Non-HDL-C at Week 8|Serum Non-HDL-C calculated at baseline and after 8 weeks of study drug administration. Non-HDL-C values were calculated as follows: Non-HDL-C (mg/dL) = TC – HDL-C.|Baseline and Week 8|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
789769|NCT00867165|Secondary|Percentage Change From Baseline in Non-HDL-C at Week 4|Serum Non-HDL-C calculated at baseline and after 4 weeks of study drug administration. Non-HDL-C values were calculated as follows: Non-HDL-C (mg/dL) = TC – HDL-C.|Baseline and Week 4|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
789770|NCT00867165|Secondary|Percentage Change From Baseline in Non-HDL-C at Week 2|Serum Non-HDL-C calculated at baseline and after 2 weeks of study drug administration. Non-HDL-C values were calculated as follows: Non-HDL-C (mg/dL) = TC – HDL-C.|Baseline and Week 2|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
789771|NCT00867165|Secondary|Percentage Change From Baseline HDL-C at Week 8|Serum HDL-C levels measured by photometry after precipitation at baseline and after 8 weeks of study drug administration.|Baseline and Week 8|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
789772|NCT00867165|Secondary|Percentage Change From Baseline HDL-C at Week 4|Serum HDL-C levels measured by photometry after precipitation at baseline and after 4 weeks of study drug administration.|Baseline and Week 4|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
789773|NCT00867165|Secondary|Percentage Change From Baseline HDL-C at Week 2|Serum HDL-C levels measured by photometry after precipitation at baseline and after 2 weeks of study drug administration.|Baseline and Week 2|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
789774|NCT00867165|Secondary|Percentage Change From Baseline in TC at Week 8|Serum TC levels measured using enzymatic methods at baseline and after 8 weeks of study drug administration.|Baseline and Week 8|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
789775|NCT00867165|Secondary|Percentage Change From Baseline in TC at Week 4|Serum TC levels measured using enzymatic methods at baseline and after 4 weeks of study drug administration.|Baseline and Week 4|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
789776|NCT00867165|Secondary|Percentage Change From Baseline in TC at Week 2|Serum TC levels measured using enzymatic methods at baseline and after 2 weeks of study drug administration.|Baseline and Week 2|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
789777|NCT00867165|Secondary|Percent Change From Baseline in LDL-C at Week 8|Serum LDL-C levels calculated at baseline and after 8 weeks of study drug administration. LDL-C were calculated by the method of Friedewald equation, LDL-C = Total Cholesterol (TC) – (High-density lipoprotein cholesterol [HDL-C] + triglyceride [TG]/5).|Baseline and Week 8|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
789778|NCT00867165|Secondary|Percent Change From Baseline in LDL-C at Week 4|Serum LDL-C levels calculated at baseline and after 4 weeks of study drug administration. LDL-C were calculated by the method of Friedewald equation, LDL-C = Total Cholesterol (TC) – (High-density lipoprotein cholesterol [HDL-C] + triglyceride [TG]/5).|Baseline and Week 4|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
789779|NCT00867165|Secondary|Percent Change From Baseline in LDL-C at Week 2|Serum LDL-C levels calculated at baseline and after 2 weeks of study drug administration. LDL-C were calculated by the method of Friedewald equation, LDL-C = Total Cholesterol (TC) – (High-density lipoprotein cholesterol [HDL-C] + triglyceride [TG]/5).|Baseline and Week 2|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
789780|NCT00867165|Secondary|Percentage Change From Baseline in Triglycerides (TG) at Week 12|Serum TG levels measured using enzymatic methods at baseline and after 12 weeks of study drug.|Baseline and Week 12|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage change||95% Confidence Interval|Least Squares Mean
789818|NCT00868192|Secondary|Association Between Levels of Thymidylate Synthase, Dihydrofolate Reductase, and Glycinamide Ribonucleotide Formyl Transferase and Ovarian Response to Pemetrexed and Bevacizumab||6 months|This outcome was not analyzed. Columbia University was to participate in this study but did not. They were to perform the correlative studies.|||||
789781|NCT00867165|Secondary|Percentage Change From Baseline in Non-HDL-C at Week 12|Serum Non-HDL-C calculated at baseline and after 12 weeks of study drug administration. Non-HDL-C values were calculated as follows: Non-HDL-C (mg/dL) = TC – HDL-C.|Baseline and Week 12|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
789782|NCT00867165|Secondary|Percentage Change From Baseline High-density Lipoprotein Cholesterol (HDL-C) at Week 12|Serum HDL-C levels measured by photometry after precipitation at baseline and after 12 weeks of study drug administration.|Baseline and Week 12|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
789783|NCT00867165|Secondary|Percentage Change From Baseline in Apolipoprotein B (Apo B) at Week 12|Serum Apo B measured at baseline and after 12 weeks of study drug administration.|Baseline and Week 12|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percent Change||95% Confidence Interval|Least Squares Mean
789784|NCT00867165|Secondary|Percentage Change From Baseline in Total Cholesterol (TC) at Week 12|Serum TC levels measured using enzymatic methods at baseline and after 12 weeks of study drug administration.|Baseline and Week 12|"Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study
medication and had a baseline value and at least one valid post-baseline evaluation."||Percentage Change||95% Confidence Interval|Least Squares Mean
789785|NCT00867165|Primary|Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12|Serum LDL-C levels calculated at baseline and after 12 weeks of study drug administration. LDL-C were calculated by the method of Friedewald equation, LDL-C = Total Cholesterol (TC) – (High-density lipoprotein cholesterol [HDL-C] + triglyceride [TG]/5).|Baseline and Week 12|"Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study
medication and had a baseline value and at least one valid post-baseline evaluation."||Percent Change||95% Confidence Interval|Least Squares Mean
789786|NCT00867321|Secondary|Tumor Response at 6 Months|Tumor response (at 6 months) is defined as the number of responses (complete or partial response per Section 11) over the number of eligible patients observed for at least 6 months. Tumor response will be evaluated using simple estimates of proportions.|6 months|No patients were analyzed for this endpoint because data was not collected for it|||||
789787|NCT00867321|Secondary|Overall Survival|Overall survival (OS) is defined as the length of time from date of registration to a) date of death due to any cause or b) last follow-up. Kaplan-Meier survival curves will be used to estimate the distribution of OS.|Up to 3 years post treatment|No patients were analyzed for this endpoint because data was not collected for it|||||
789788|NCT00867321|Primary|Time to Progression (TTP) (Phase II)|Time to progression is defined to be the length of time from study registration to a) date of disease progression as defined by section 11.0, or b) last follow-up. If a patient dies without documentation of disease progression, the patient will be considered to have had a tumor progression at the time of death unless there is sufficient documented evidence to conclude no progression occurred prior to death. Kaplan-Meier survival curves will be used to estimate the distribution of TTP.|From baseline up to 3 years post treatment|6 of 7 patients have had at least one post-baseline assessment of disease and were used for this endpoint.||years||95% Confidence Interval|Median
789789|NCT00867321|Primary|Maximum Tolerated Dose (Phase I)|MTD is defined as the dose level below the lowest dose that induces dose limiting toxicity in at least one-third of patients (at least 2 of a maximum of 6 new patients). If dose level (-1) is not tolerable, but dose (-3) or (-2) is below or at MTD, testing of alternate dose levels (-2a, -3a, -3b) will occur as outlined in the table. The number of dose limiting toxicities will be reported here.|From baseline up to 3 years post treatment|All eligible patients were treated and analyzed.||Participants|||Count of Participants
789790|NCT00867360|Secondary|% Change in Mean Evening Pre- and Post- Florinef Cortisol After Treatment With Either Mifepristone or Placebo|"Time 1 (baseline) = Difference in cortisol level from Day 1 (pre-florinef mean evening cortisol) at Baseline less Day 2 (post-florinef mean evening cortisol) at baseline
Time 2 (post- mife or placebo treatment) = Difference in cortisol level from Day 22 (pre-florinef mean evening cortisol) and Day 23 (post-florinef mean evening cortisol level).
All measurements were the percent change in mean cortisol level from 6 pm to 10 pm. Cortisol levels are expressed as ug/dL
Percent change in cortisol decrease between Time 2 and Time 1 post florinef should be greater with mifepristone than placebo, reflecting enhanced mineralocorticoid receptor activity."|Day 23|||percentage change||Standard Deviation|Mean
789791|NCT00867360|Primary|Change in Mean Cortisol Level|The reported value is the difference in mean evening cortisol from baseline to Day 9 The mean evening cortisol is calculated from the hourly cortisol value taken from 1800 hrs to 0100 hrs for both time points. The outcome measure is the difference of mean evening cortisol from Day 9 less the mean evening cortrisol from baseline. Negative values indicate a reduction in cortisol levels at Day 9, whereas positive values indicate an increase in cortisol at Day 9. Serum cortisol levels are reported in ug/dL|Day 1 to Day 9 difference|Change in cortisol from Day 1 to Day 9||ug/dL||Standard Deviation|Mean
789792|NCT00867360|Primary|Change in Psychotic Symptoms Subscale (PSS) of the Brief Psychiatric Rating Scale (BPRS)|"The BRPS is a rating scale of various psychiatric symptoms. Each item is rated on a scale of 1 to 7, with 1 being not present. The PSS is the sum of 4 items from the BPRS, which indicates the level of positive psychotic symptoms.. Thus, the range for the PSS is 4 to 28, with higher scores indicating greater levels of positive psychotic symptoms.
For ease of interpretation, the sum of the PSS then has 4 items subtracted so that a score of 0 (instead of 4) indicates that there are no psychotic symptoms. In doing this, the range for the PSS becomes 0 to 24), with larger values indicating more positive psychotic symptoms.
The measure is the change score of PSS total day 1 less PSS total Day 9. 0 indicates no change, where as positive numbers indicate a decrease in psychotic symptoms."|baseline to day 9|||units on a scale||Standard Deviation|Mean
789793|NCT00867529|Secondary|Incidence and Severity of Acute and Chronic GVHD Evaluated Per an Adapted Version of Common Terminology Criteria for Adverse Events (CTCAE) Version 2.0|Number of patients with grade 3 or 4 acute GVHD by day 100, or with chronic/extensive GVHD starting before day 100|Through day +100 after transplant|||Participants|||Count of Participants
789797|NCT00867568|Secondary|Progression Free Survival (PFS) of Participants Using Days From Start of Study Drug Until Progression|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Up to 4 years|18 subjects enrolled, one subject censored due to age, 5 subjects not evaluable. Analysis population= 12 patients.||months||Full Range|Mean
789798|NCT00867568|Secondary|Number of Patients With an Overall Response Rate (ORR) of PR or CR|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|1 year|18 subjects enrolled, one subject censored due to age, 5 subjects not evaluable. Analysis population= 12 patients.||participants|||Number
789799|NCT00867568|Secondary|Tmax of TPI 287in Pediatrics Using Pharmacokinetic (PK) Testing.||Cycle 3 day 1 at Pre dose, 0 (end of infusion), 0.25, 0.5, 1, 2, 4, and 6 hours post dose|Six patients at the MTD dose of 125mg/m2/dose||hour||Full Range|Mean
789800|NCT00867568|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|To determine the safety, tolerability and maximum tolerated dose (MTD) of TPI 287 as a single agent and collect exploratory data on the safety and tolerability of TPI 287 in combination with temozolomide (TMZ) in pediatric and young adult patients with refractory or recurrent neuroblastoma or medulloblastoma|2 years|||participants|||Number
789801|NCT00867659|Primary|Ovarian Volumes as a Predictor of OHSS Severity|ultrasound measurements of both ovaries|30 days|||cc||Full Range|Mean
789802|NCT00867659|Primary|Volume of Ascites in the Abdomen is Indicative of the Severity of OHSS|evaluate by ultrasound examination, physical examination and blood work the incidence of ovarian hyperstimulation syndrome in oocyte donors receiving a single injection of 3 mg Cetrotide Acetate.|4 weeks|||cc (volume of ascites)||Full Range|Mean
789803|NCT00868101|Secondary|Troponin I|Seric concentration of troponin I, a myocardial cell injury marker. We measured by solid-phase chemiluminescence immunoassay.|24 hours|||pg/mL||Standard Deviation|Mean
789804|NCT00868101|Primary|Interleucine 8|Quantification of interlecine 8 (a pro-inflammatory protein) using the ELISA method|24 hours|||pg/mL||Standard Deviation|Mean
789805|NCT00868101|Primary|IkB-alpha Expression|"Expressure of gene of an inhibitory protein called kappa-B alpha (IkB-alpha). Inhibits the inflammatory response protein called kappa-B nuclear factor. To measure that expression we used a real time protein chain reaction (RT-PCR), always comparing with an endogenous protein expression (this way, the encountered value is apresented in arbitraries units, that means how much times the expression of the protein IkB-alpha is bigger than the endogenous protein that present a invariable value."|24 hours|||units on a scale||Standard Deviation|Mean
789806|NCT00868101|Secondary|NT-proBNP|Plasma concentration of the amino-terminal of B-type natriuretic peptite (NT-proBNP)was measured by enzyme electrochemiluminescence immunoassay.|24 hours|||pg/mL||Standard Deviation|Mean
789813|NCT00868192|Post-Hoc|CA-125 Response|A CA-125 response was defined as at least a 50% reduction in CA-125 levels from a pretreatment sample following guidelines described by the Gynecological Cancer Intergroup.|6 months|7 participants were not evauable by CA-125 criteria.||participants|||Number
789814|NCT00868192|Post-Hoc|Overall Response Rate|"Overall response rate = complete response + partial response
Complete response = disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart.
Partial response = at least a 30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be non unequivocal progression of non-target lesions and no new lesions."|6 months|||percentage of participants||95% Confidence Interval|Number
789815|NCT00868192|Post-Hoc|Overall Survival (OS)|OS = observed length of time from entry into the study to death or date of last contact|Median follow-up was 25.7 months (range 3.0-47.2 months)|||months||95% Confidence Interval|Median
789816|NCT00868192|Post-Hoc|Progression-free Survival (PFS)|PFS = Period from study entry until disease progression, death, or date of last contact|Median follow-up was 25.7 months (range 3.0-47.2 months)|||months||95% Confidence Interval|Median
789817|NCT00868192|Post-Hoc|Overall Survival (OS)|OS = observed length of time from entry into the study to death or date of last contact|12 months|||percentage of participants||95% Confidence Interval|Number
789819|NCT00868192|Secondary|Gene Expression as Assessed by Illumina cDNA Mediated Annealing, Selection, Extension and Ligation (DASL) Microarray From Paraffin-embedded Tumor Specimens With Response to Pemetrexed and Bevacizumab||6 months|This outcome was not analyzed. Columbia University was to participate in this study but did not. They were to perform the correlative studies.|||||
789820|NCT00868192|Secondary|Frequency of Clinical Response|As measured by RECIST criteria|6 months|||participants|||Number
789821|NCT00868192|Secondary|Toxicity Associated With Bevacizumab and Pemetrexed|Detailed serious adverse events and other adverse events are shown in the adverse event module of the results.|6 months|||percentage of participants|||Number
789822|NCT00868192|Secondary|Distribution of Overall Survival (OS)|OS = observed length of time from entry into the study to death or date of last contact|Median follow-up was 25.7 months (range 3.0-47.2 months)|||months||95% Confidence Interval|Median
789823|NCT00868192|Secondary|Distribution of Progression-free Survival (PFS)|PFS = Period from study entry until disease progression, death, or date of last contact|Median follow-up was 25.7 months (range 3.0-47.2 months)|||months||95% Confidence Interval|Median
789824|NCT00868192|Primary|Progression-free Survival (PFS)|PFS = Period from study entry until disease progression, death, or date of last contact|6 months|||percentage of participants||95% Confidence Interval|Number
789825|NCT00868218|Secondary|Immunogenicity of a Non-adjuvanted and 3rd Generation ISCOM™ Adjuvanted Virosomal H5N1 Influenza Vaccine|Number of participants with haemagglutination inhibition tigers >= 32 at the long term time point (1 year post vaccination).|one year|||participants|||Number
789826|NCT00868218|Primary|Adverse Events||42 days|||participants|||Number
789827|NCT00868218|Primary|Solicted Adverse Events|The primary endpoints of the trial are the local and systemic adverse events and tolerability of parenterally administered virosomal H5N1 influenza vaccine with or without 3rd generation ISCOM™ adjuvant.|three months|||participants|||Number
789828|NCT00868231|Secondary|Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 0-24 hr at Day 1 on Treatment||Day 1|Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1||Liters||Standard Error|Least Squares Mean
789829|NCT00868231|Secondary|Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 12-24 hr at Day 1 on Treatment||Day 1|Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1||Liters||Standard Error|Least Squares Mean
789830|NCT00868231|Secondary|Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 0-12 hr at Day 1 on Treatment||Day 1|Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1||Liters||Standard Error|Least Squares Mean
789831|NCT00868231|Secondary|Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 0-24 hr at Day 15 on Treatment||Day 15|Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1||Liters||Standard Error|Least Squares Mean
789832|NCT00868231|Secondary|Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 12-24 hr at Day 15 on Treatment||Day 15|Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1||Liters||Standard Error|Least Squares Mean
789833|NCT00868231|Secondary|Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 0-12 hr at Day 15 on Treatment||Day 15|Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1||Liters||Standard Error|Least Squares Mean
789834|NCT00868231|Secondary|Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-24 hr at Day 1 on Treatment||Day 1|Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1||Liters||Standard Error|Least Squares Mean
789835|NCT00868231|Secondary|Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 12-24 hr at Day 1 on Treatment||Day 1|Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1||Liters||Standard Error|Least Squares Mean
789836|NCT00868231|Secondary|Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC0-12) in Liters at Day 1 on Treatment||Day 1|Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1||Liters||Standard Error|Least Squares Mean
789837|NCT00868231|Secondary|Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-24 hr at Day 15 on Treatment||Day 15|Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1||Liters||Standard Error|Least Squares Mean
789838|NCT00868231|Secondary|Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 12-24hr at Day 15 on Treatment||Day 15|Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1||Liters||Standard Error|Least Squares Mean
789839|NCT00868231|Primary|Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-12 hr at Day 15 on Treatment.||Day 15|Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1||Liters||Standard Error|Least Squares Mean
789862|NCT00868517|Secondary|Attrition Rates|Examined attendance rates in attending group sessions to examine attrition rates.|t=2 months|For this measure, participants in wait list control group not analyzed as did not participate in group sessions.||% of sessions attended||Standard Deviation|Mean
789840|NCT00868296|Primary|Growth Parameters Z-scores|Z-Score is a statistical measure to evaluate how a single data point compares to a standard. A Z-Score describes whether a mean is above or below the standard and how unusual the measurement is. Z-scores primarily range from -3 to +3. A Z-score of 0 indicates the same mean, >0 a greater mean, and <0 a lesser mean than the standard. In this study, infant growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.|6 weeks|Safety population (all patients with ≥1 dose of study drug) who also had baseline and end of study evaluations. Data point pairs were analyzed. All patients in study 3001B3-335 originated from study 3001B3-331 or -333 and baselines from the original study they were in were used.||units on scale||Standard Deviation|Mean
789841|NCT00868296|Primary|Number of Patients With Laboratory Test Values of Potential Clinical Importance During Treatment Period|Pre-defined criteria were established for each laboratory test to define the values that would be identified as of potential clinical importance. Criteria are as follows: Potassium ≤ 3.0 mEq/L or ≥ 6.2 mEq/L; Carbon dioxide < 12 mEq/L or > 35 mEq/L; Total bilirubin > 1.5xULN; CPK > 3xULN; Gastrin ≥ 600 pg/mL; Neutrophils < 10% or > 80%; Platelet count < 100 x10 to the third power/ul or > 600 x10 to the third power/ul; Urine protein albumin > 2+ (dipstick) 100mg/dL or positive; Urine leukocyte esterase > 2+ (dipstick) moderate or positive.|6 weeks|Patients who received ≥1 dose of pantoprazole and had laboratory test results. The number of patients (n) tested varied by test, variations shown (low dose, high dose): Carbon dioxide (n=7,26), CPK (n=12,42), Gastrin (n=9,25), Neutrophils (n=12,44), Platelet count (n=12,41), Urine protein albumin (n=10,38), Urine leukocyte esterase (n=10,38).||patients|||Number
789842|NCT00868309|Secondary|>50,000 Platelets/mm3|Thrombocytopenia during follow up period. Two weeks|Follow up after maintenance dose|||participants|||Number
789843|NCT00868309|Primary|Detection of Plasma Venom Levels During the Post Acute Treatment Period.||Follow up after Maintenance doses were completed. Two Weeks.|||participants|||Number
789844|NCT00868348|Secondary|Pain Intensity During Daily Activity|Pain intensity Visual Analogue Scale (VAS) (VAS; 0, no pain, and 100 mm, worst pain possible)|16 weeks after surgery|||mm||Inter-Quartile Range|Median
789845|NCT00868348|Secondary|Length of Hospital Stay||From the day of surgery until discharge|||days||Inter-Quartile Range|Median
789846|NCT00868348|Secondary|Home Readiness|Ability to meet discharge criteria (home readiness)|time to fulfilment of discharge criteria|||days||Inter-Quartile Range|Median
789847|NCT00868348|Secondary|Pain Intensity Scores During Walking|Pain intensity Visual Analogue Scale (VAS) (VAS; 0, no pain, and 100 mm, worst pain possible)|6-24 hours postoperatively|||mm||Inter-Quartile Range|Median
789848|NCT00868348|Secondary|Time to First i.v. Patient Controlled Analgesia (PCA) Morphine Request||within 48 hours after surgery|||min||Inter-Quartile Range|Median
789849|NCT00868348|Primary|Morphine Consumption|Consumption of intravenous (i.v.) patient-controlled analgesia (PCA) morphine during the first forty-eight hours after surgery|48 hours after surgery|||mg||Inter-Quartile Range|Median
789850|NCT00868374|Primary|Change in 17 Item Hamilton Rating Scale for Depression (HAM-D-17)|The Hamilton Rating Scale for Depression (HAM-D-17) is a 17-item clinician-rated measure that queries symptoms of depression, with a possible total score ranging for 0 to 52. A total score of 0-7 indicates no depression, a total score of 8-12 indicates doubtful depression, a total score of 13-17 indicates mild depression, a total score of 18-24 indicates moderate depression and a total score of 25-52 indicates severe depression.|Week 0 - Week 8|||units on a scale||95% Confidence Interval|Mean
789851|NCT00868439|Secondary|Time to First Elevated Serum K+ > 5.5 mEq/L.||28 Days|||days||95% Confidence Interval|Median
789852|NCT00868439|Secondary|Proportion of Participants With an Increase in Serum Potassium Level From Baseline to the End of the 28-day Treatment Period That Was ≥ 0.5 mEq/L||Baseline and Day 28|Analysis was determined using LOCF.||percentage of participants|||Number
789853|NCT00868439|Secondary|Proportion of Participants Whose Spironolactone Dose Was Increased.||28 Days|||percentage of participants|||Number
789854|NCT00868439|Secondary|Proportion of Participants Discontinuing the Study Due to Serum Potassium Elevation (Serum K+ > 5.5 mEq/L).|Analysis based on local laboratory data.|28 Days|||percentage of participants|||Number
789855|NCT00868439|Secondary|Proportion of Participants With a Serum Potassium Level During the 28-day Treatment Period That Was > 5.5 mEq/L.|Analysis based on central laboratory data.|28 Days|||percentage of participants|||Number
789856|NCT00868439|Primary|Change From Baseline in Serum Potassium to the End of the 28-day Treatment Period.||Baseline and Day 28|Analysis was determined using Last Observation Carried Forward (LOCF).||mEq/L||Standard Error|Least Squares Mean
789857|NCT00868452|Secondary|Mean Change From Baseline to Endpoint (Week 6) in: Sheehan Disability Scale (SDS) Total Score|STS total score ranges from a minimum of 0 to a maximum of 30. Lower values represent a better score, higher values represent a worse score. Similarly, greater negative change from baseline represents improvement, and positive changes from baseline represent worsening.|Baselin Week 6|Full analysis set (intent-to-treat population)||units on a scale||Standard Deviation|Least Squares Mean
789858|NCT00868452|Secondary|Mean Change From Baseline to Endpoint (Week 6) in: Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression)|CGI-EP-S depression score ranges from a minimum of 0 to a maximum of 7. Lower values represent a better score, higher values represent a worse score. Similarly, greater negative change from baseline represents improvement, and positive changes from baseline represent worsening.|Baseline Week 6|Full analyis set (intent-to-treat population)||units on a scale||Standard Error|Least Squares Mean
789859|NCT00868452|Primary|Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Endpoint (Week 6)|MADRS total score ranges from a minimum of 0 to a maximum of 60. Lower values represent a better score, higher values represent a worse score. Similarly, greater negative change from baseline represents improvement, and positive changes from baseline represent worsening.|Baseline, Week 6|Full analysis set (intent-to-treat population)||units on a scale||Standard Error|Least Squares Mean
789860|NCT00868517|Secondary|Fragmented Sleep Patterns-Sleep Efficiency|Disruptive sleep patterns that were analyzed by looking at Sleep Efficiency(SE). Morin sleep diaries (MSD) and wrist actigraphs (WA) were the study instruments used to collect this data.|t=2 months|||percentage of TST to time in bed||95% Confidence Interval|Mean
789861|NCT00868517|Secondary|Number of Participants That Were Satisfied Based on Veteran Satisfaction Scores for True Group Acupuncture vs. Sham Group Acupuncture||t= 2 months|For this measure, participants in wait list control group not analyzed as did not participate in group sessions.||participants|||Number
789864|NCT00868517|Secondary|Fragmented Sleep Patterns-Total Sleep Time, Sleep Latency, and Naps|Disruptive sleep patterns were analyzed by looking at Total Sleep Time (TST), Sleep Latency (SL), and Naps (short episodes of sleep at times other than bedtime). Morin sleep diaries (MSD) and wrist actigraphs (WA) were the study instruments used to collect this data.|t=2 months|||minutes||95% Confidence Interval|Mean
789865|NCT00868517|Primary|Perceived Sleep Quality|"Perceived sleep quality: subjective assessment of how restorative and undisturbed sleep has been. Measured by Insomnia Severity Index (ISI) and Morin sleep diary refreshness and soundness ratings.
ISI: 7-item, self-report questionnaire based on DSM-IV criteria for insomnia. ISI scores range from 0 to 28 with higher scores reflecting greater insomnia. Total scores were reported, and an ISI cutoff total score of > 8 is indicative of probable insomnia.
The Morin Sleep Diary refreshness and soundness ratings are based on a 5-point Likert scale with scores ranging from 1 to 5. Scores for these two questions were reported and higher scores indicate higher perceived sleep quality."|t=2 months|||units on a scale||95% Confidence Interval|Mean
789866|NCT00868530|Other Pre-specified|Average Dose of Xyntha Infusions Required Per Hemorrhage|The average dose of Xyntha per hemorrhagic event was calculated as total dose of Xyntha throughout the study (in IU) divided by total number of hemorrhage incidence.|Day 1 to Month 6 or Early Termination Visit|The FAS consisted of all participants who were treated and had at least 1 evaluable efficacy assessment after treatment.||Dose/Bleed (IU)||Standard Deviation|Mean
789867|NCT00868530|Other Pre-specified|Frequency of Xyntha Infusions Required Per Hemorrhage|The mean frequency of Xyntha infusions per hemorrhage was calculated as total number of injections throughout the study divided by total number of hemorrhagic events.|Day 1 to Month 6 or Early Termination Visit|The FAS consisted of all participants who were treated and had at least 1 evaluable efficacy assessment after treatment.||Infusions||Standard Deviation|Mean
789868|NCT00868530|Secondary|Number of Participants With Thrombosis||Baseline up to 6 months|The SS consisted of all participants who had taken at least 1 dose of investigational drug.||Participants|||Number
789869|NCT00868530|Secondary|Number of Participants With Thrombosis Allergic-Type Reactions||Baseline up to 6 months|The Safety Set (SS) consisted of all participants who had taken at least 1 dose of investigational drug.||Participants|||Number
789870|NCT00868530|Secondary|Number of Participants With Less Than Expected Therapeutic Effect (LETE)|The incidence of LETE, defined for on-demand treatment as no response after each of 2 successive infusions within 24 hours for the same bleeding event in the absence of confounding factors.|24 hours after each of 2 successive infusion, up to 6 months|The FAS consisted of all participants who were treated and had at least 1 evaluable efficacy assessment after treatment.||Participants|||Number
789871|NCT00868530|Secondary|FVIII Recovery : Change From Baseline in FVIII Concentration|FVIII recovery was assessed by evaluating the change in FVIII concentration at 6 months compared to baseline.|Day 1 and Month 6 or Early Termination Visit|The FAS consisted of all participants who were treated and had at least 1 evaluable efficacy assessment after treatment. Participants with missing data were not included.||IU/dL per IU/kg||Standard Deviation|Mean
789872|NCT00868530|Primary|Number of Participants With Factor VIII (FVIII) Inhibitor Development|Incidence of FVIII inhibitor was defined as any result determined as positive at local laboratory, and confirmed at central laboratory. Incidence was stratified by participant exposure history: Minimally Treated Patients (MTPs): those who had received at least 1 prior FVIII infusion, and <= 100 documented Exposure Days (EDs), while Previously Treated Patients (PTPs): those who had received >100 documented prior EDs. When number of prior EDs for an individual was not known to be at least 100, participants were included in the MTP population.|Day 1 and Month 6 or Early Termination Visit|The Safety Set (SS) consisted of all participants who had taken at least 1 dose of investigational drug.||Participants|||Number
789873|NCT00868530|Primary|Investigator Hemostatic Efficacy Assessment 24 Hours Post Infusion|The Investigator Hemostatic Efficacy Assessment was based on a 4-point rating scale (Excellent = 1: definite pain relief or improvement in signs of bleeding, with no additional infusion, Good = 2: definite pain relief or improvement in signs of bleeding, Moderate = 3: probable or slight improvement, No Response = 4: no improvement at all between infusions).|24 hours post infusion|The FAS consisted of all participants who were treated and had at least 1 evaluable efficacy assessment after treatment.||Units on a scale||Standard Deviation|Mean
789874|NCT00868530|Primary|Investigator Hemostatic Efficacy Assessment 8 Hours Post Infusion|The Investigator Hemostatic Efficacy Assessment was based on a 4-point rating scale (Excellent = 1: definite pain relief or improvement in signs of bleeding, with no additional infusion, Good = 2: definite pain relief or improvement in signs of bleeding, Moderate = 3: probable or slight improvement, No Response = 4: no improvement at all between infusions).|8 hours post infusion|The Full Analysis Set (FAS) consisted of all participants who were treated and had at least 1 evaluable efficacy assessment after treatment.||Units on a scale||Standard Deviation|Mean
789875|NCT00868699|Secondary|Mean Change From Baseline to Endpoint (Week 6) in: Sheehan Disability Scale (SDS) Total Score|"Sheehan Disability Scale (SDS) total score is a subject-rated assessment of a subject's level of depression.
The SDS total score ranges from a minimum of 0 to a maximum of 30. For the SDS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome.
The SDS contains three (3) items. The total score is computed as the sum of the scores for the 3 items."|Baseline to Week 6|Intent-to-treat population is analyzed. Number of participants in table is not consistent with intent-to-treat population because: if one or more items are missing at a study visit, as can occur when a subject opts out of the work/school item because it does not apply, the authors of the scale recommend setting the total score to missing||units on a scale||Standard Error|Least Squares Mean
789876|NCT00868699|Secondary|Mean Change From Baseline to Endpoint (Week 6) in: Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression)|"Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) score (depression) is a clinician-rated assessment of a subject's level of depression.
The CGI depression score ranges from a minimum of 0 to a maximum of 7. For the CGI depression score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome."|Baseline to Week 6|Intent-to-treat population is analyzed.||units on a scale||Standard Error|Least Squares Mean
789877|NCT00868699|Primary|Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Endpoint (Week 6)|"Montgomery-Asberg Depression Rating Scale (MADRS)is a clinician-rated assessment of a subject's level of depression.
The MADRS total score ranges from a minimum of 0 to a maximum of 60. For the MADRS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome.
The MADRS contains ten (10) items. The total score is computed as the sum of the scores for the 10 items."|Baseline to Week 6|Intent-to-treat population is analyzed.||units on a scale||Standard Error|Least Squares Mean
789878|NCT00868712|Secondary|International Normalized Ratio|The International Normalized Ratio (INR) is a standardized lab value that measures the intensity of anticogulation using warfarin. It is used to monitor patients taking warfarin.|EBCT scan is done at time of enrollment of patient into 1 of 3 groups based on warfarin use duration: <6 months; 6-24 months; >24 mos.|||ratio||Standard Deviation|Mean
789879|NCT00868712|Primary|Coronary Calcification (Presence and Degree as Measured by Agatston Score) Attributed to Duration of Warfarin Use in Months After Controlling for Standard Cardiovascular Risk Factors to Include the Framingham Risk Score|The Agatston score is calculated using a non-contrast computed tomography (CT) scan to measure for the presence and severity of coronary artery disease through identification of calcification in the coronary arteries. Scores can range from 0 to several thousands. The measure is without units. Score categories are as follows: 0 = no coronary disease; 1-100 = low amount of coronary artery disease; 101-400 = moderately elevated score / moderate coronary artery disease; 401-1000 = severely elevated score; >1000 very severely elevated score. Higher Agatston scores corelate with more coronary artery disease and predict a higher risk of coronary heart disease events and mortality.|EBCT scan is done at time of enrollment of patient into 1 of 3 groups based on warfarin use duration: <6 months; 6-24 months; >24 mos.|After interim analysis following n=70 showed no effect, further enrollment was halted.||Agatston Score||Standard Deviation|Mean
789880|NCT00868751|Secondary|Measurement of Sustained Clinical Response to Tocilizumab, Including Active Joint Count, Joints With Limited Range of Motion, and Absence of Fever or Rash.|To assess sustained clinical response to tocilizumab, including active joint count, joints with limited range of motion, and absence of fever|At weeks 8, 12, 16 of treatment, and every 8 weeks thereafter|No data are available because data were not collected|||||
789881|NCT00868751|Secondary|Measurement of Laboratory Parameters of Active Disease, Specifically C-reactive Protein, Hemoglobin, Platelets, White Blood Cell Count, Ferritin, Immunoglobulins.|To assess normalization of laboratory parameters of active disease, specifically C-reactive protein, hemoglobin, platelets, white blood cell|At weeks 8, 12, and 16 of treatment, and every 8-12 weeks thereafter|No data are available because data were not collected|||||
789882|NCT00868751|Primary|Number of Participants With at Least One Adverse Event|To evaluate the safety of tocilizumab administration in this subject|Ongoing, throughout 24 month study period|No data are available because data were not collected||Participants|||Count of Participants
789883|NCT00868751|Primary|Efficacy of Tocilizumab as Defined by Reduction of Oral Prednisone Dose by at Least 20%, or to Less Than 0.5mg/kg/Day, Whichever is of Lesser Daily Dose, While Maintaining an ACR JIA30 Response||At weeks 12 and 16 of treatment versus week 0 (pretreatment)|No data are available because data were not collected|||||
789884|NCT00868751|Primary|Efficacy of Tocilizumab as Defined by Presence of an Equal to or Greater Than 30% Improvement in JIA Core Set (i.e. ACR JIA30 Response)||At week 12 of treatment versus week 0 (pretreatment)|No data are available because data were not collected|||||
789885|NCT00868790|Primary|Number of Participants Who Discontinued Study Treatment Due to an AE|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR’s product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of the SPONSOR’s product, is also an AE.|From first dose of study treatment (Week 0 Visit) to Week 16 Visit (up to 16 weeks).|All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.||Participants|||Number
789886|NCT00868790|Primary|Number of Participants With At Least One Adverse Event (AE) in the Treatment or Post-Treatment Periods|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR’s product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of the SPONSOR’s product, is also an AE.|From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).|All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.||Participants|||Number
789887|NCT00868790|Secondary|Percentage Change From Baseline (BL) After 4-Week Treatment in Low-Density Lipoprotein C (LDL-C) Levels|Blood samples were obtained from all participants to measure LDL-C levels at Week 0 (Baseline) and Week 4 of each treatment period (Week 4 Visit, Week 8 Visit, Week 12 Visit, and Week 16 Visit). For each visit, LDL-C was measured over 2 days. The average of duplicate measurements (when available) was used in the analysis.|Week 0 Visit (Baseline), Week 4 Visit, Week 8 Visit, Week 12 Visit, and Week 16 Visit|All randomized participants who took at least 1 dose of study treatment and had a valid reading at timepoint.||percentage change from BL||90% Confidence Interval|Least Squares Mean
789902|NCT00869141|Primary|Rate of Hypertensive Phase After Ahmed Valve Implantation for Glaucoma|Intraocular pressure more than 21 mmHg during the first 6 months after Ahmed valve implantation after the pressure has been reduced to less than 22 mmHg in the first postoperative week|within 6 months after surgery|||participants|||Number
789888|NCT00868790|Secondary|Change From BL After 4-Week Treatment in 2-hour Post-Meal Glucose (PMG) Levels|Two-hour PMG was analyzed in both non-domiciled and domiciled participants. Non-domiciled participants completed a 3-point meal tolerance test (MTT) at Week 0 (Baseline) and Week 4 Visits of Treatment Period 1. Participants completed 12-hr fasting prior to the Week 0 (Baseline) and Week-4 clinic visits. Fasting blood samples were obtained at the beginning of these clinic visits, after which participants consumed a standardized meal (1 nutrition bar and 1 can of nutrition drink), and then completed the MTT, in which plasma glucose was measured at 30 min and 120 min (2 hr) post-meal. The 2-hr PMG data also include data from domiciled participants, based on 2-hr post-morning meal glucose levels in the 24-hr blood glucose sample at the Week 4 and Week 8 Visits. The 2-hour PMG was analyzed using an LDA model, and change from baseline (Week 0) after 4-week treatment in 2-hour PMG was reported.|Week 0 Visit (Baseline), Week 4 Visit, Week 8 visit|All randomized participants receiving ≥1 dose of therapy and having MTT measurement either at Week 0 (BL) or end of Treatment Period 1. N=number of participants included in the Longitudinal Data Analysis (LDA) model||mg/dL||Standard Error|Least Squares Mean
789889|NCT00868790|Secondary|Change From Baseline (BL) After 4-Week Treatment in Fasting Plasma Glucose (FPG)|Fasting blood samples were obtained during study site visits at Baseline (Week 0 Visit) and Week 4 of each treatment period (Week 4 Visit, Week 8 Visit, Week 12 Visit, Week 16 Visit). Participants were counseled to fast (no food or drink except water and non-study medications, as directed) for at least 12 hours prior to all study visits. FPG was analyzed using an LDA model, and change from baseline (Week 0) after 4-week treatment in FPG was reported.|Week 0 Visit (Baseline), Week 4 Visit, Week 8 Visit, Week 12 Visit, Week 16 Visit|All randomized participants receiving ≥1 dose of therapy and having FPG measurement either at BL or end of Treatment Period. Number of Participants Analyzed=number of participants included in the LDA model.||mg/dL||Standard Error|Least Squares Mean
789890|NCT00868790|Primary|Change From Baseline (BL) After 4-Week Treatment in Weighted Mean Glucose (WMG)|The primary efficacy outcome in this study was the assessment of 24-hour weighted mean glucose (WMG) levels for domiciled participants after 4-week treatment (Periods 1 and 2 only). At selected study sites, a subset of participants domiciled (stayed) overnight and underwent 24-hour blood sampling at the Week 0 Visit (Baseline), Week 4 Visit (end of Period 1), and Week 8 Visit (end of Period 2). Domiciled participants were not expected to follow a weight-maintaining diet while receiving standard meals from a dietician or licensed healthcare professional. WMG was calculated as the weighted average value of the glucose from the 24-hour blood sample (for Baseline, Week 4, and Week 8) and analyzed using a Longitudinal Data Analysis (LDA) model. Results were expressed as the change from baseline after 4-week treatment in 24-hour WMG.|Week 0 Visit (Baseline), Week 4 Visit, Week 8 Visit|All randomized domiciled participants receiving ≥1 dose of therapy and having 24-hour WMG measurement either at BL or end of Treatment Period 1 or 2. Number of Participants Analyzed=number of participants included in LDA model. Participants in MK-3577 25 mg BID group did not undergo 24-hour glucose sampling and were not analyzed.||mg/dL||Standard Error|Least Squares Mean
789891|NCT00868959|Secondary|Change From Open-label Extension Baseline to Week 24 (Month 6/LOCF Endpoint) in Clinical Global Impressions Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression)|"This CGI-BP-S is a clinician-rated assessment of the subjects current severity of depression and ranges from 1=Normal, not ill to 7=Very severly ill. Higher scores are associated with greater severity."|24 weeks|||units on a scale||Standard Deviation|Mean
789892|NCT00868959|Secondary|Change From Open-label Extension Baseline to Week 24 (Month 6/LOCF Endpoint) in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|The MADRS is a clinician-rated assessment of the subject’s level of depression. Ten items are rated on a Likert scale, from 0=”Normal” to 6=”Most Severe”. The MADRS total score is calculated as the sum of ten items: reported sadness, apparent sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity.|24 weeks|||units on a scale||Standard Deviation|Mean
789893|NCT00868959|Primary|Number of Participants With Serious and Non-serious Treatment-emergent Adverse Events Who Have Completed 24 Weeks of Extension Study Treatment|Rate of treatment-emergent adverse events in subjects who have completed (ie, reached 6-week endpoint) of Study D1050235 (NCT00868452), Study D1050236 (NCT00868699) or Study D1050292 (NCT01284517)|24 weeks|||participants|||Number
789894|NCT00868998|Secondary|Toxicity|Data was not analyzed due to poor accrual.|Prior to day 4 and on day 12||||||
789895|NCT00868998|Primary|Response Rate|Data was not analyzed due to poor accrual.|10 weeks||||||
789896|NCT00869050|Primary|Number of Participants With Complete Response (CR)|CR according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, which is defined as disappearance of all target lesions (primary and metastases), signs, symptoms, and biochemical changes related to the tumor for >4 weeks, during which no new lesions may appear and no existing lesion may enlarge.|12 months|28/38 analyzed.||participants|||Number
789897|NCT00869050|Primary|Number of Participants With Partial Response (PR)|PR according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, which is defined as a reduction of ≥ 30% in the sum of the longest diameter for all target lesions lasting > 4 weeks, during which no new lesions may appear, when compared with with pretreatment measurements.|12 months|28/38 analyzed.||participants|||Number
789898|NCT00869089|Primary|Improvement in Prurigo Nodularis||24 weeks|Subjects who completed the study were analyzed.||participants|||Number
789899|NCT00869128|Primary|Sleep Efficiency|Sleep efficiency is the percentage of time patients were asleep while in bed as scored by the actigraphic sleep algorithm assessed in the 3 consecutive last nights of each period|3 weeks|ITT||Percentage of time asleep||Standard Deviation|Mean
789900|NCT00869141|Primary|Intraocular Pressure of Eyes With Hypertensive Phase Versus Without Hypertensive Phase|intraocular pressure of eyes with hypertensive phase versus without hypertensive phase|1 year after surgery|Please note that these two groups were different from those groups in previous comparison. The patients that developed hypertensive phase were compared to those that did not developed hypertensive phase, so the number of patients in these two groups and the mean pressure at 1 year +/-standard deviation results were different.||mmHg in 1 year postop||Standard Deviation|Mean
789901|NCT00869141|Primary|Intraocular Pressure Control After Ahmed Valve Implantation for Glaucoma|intraocular pressure comparison between groups after the Ahmed valve implantation|3 weeks after surgery|Eye pressure at postop 3-week is reported||mmHg at postop 3-week||Standard Deviation|Mean
789903|NCT00869167|Primary|Insomnia Severity Index|"The change in ISI and PSQI from baseline to end of study will be compared between the two groups.
PSQI has a score range of 0-21, with lower the number being less sleep disturbances ISI has a score range of 0-28, with lower score meaning less insomnia symptoms"|5 weeks|The 2 subjects in the Ramelteon group completed the study. The 1 subject in the placebo group did not complete the study.||units on a scale||Standard Deviation|Mean
789904|NCT00869167|Secondary|Daytime Lung Function (Peak Flow Monitoring) in Liter/Min||baseline and during treatment period (during 5th week)|This measure was added during the study and no subjects completed the measure.|||||
789905|NCT00869167|Secondary|Daytime Performance (Digit Symbol Substitution Test)|"DSST tests the number of correct digit-symbol pairs that an individual can identify within an allotted period (60-90 sec). It test memory and concentration, among other parameters.
DSST score can range from 0-125, with 125 being the most number correct during the allotted time period."|baseline and post-treatment (at end of 5 weeks)|The 2 subjects in the Ramelteon group completed the study. The 1 subject in the placebo group did not complete the study.||Number correct||Standard Deviation|Mean
789906|NCT00869167|Secondary|Daytime Sleepiness (Epworth Sleepiness Scale)|Score of 0-24, with 24 being the most sleepy|baseline and post-treatment (at end of 5 weeks)|The 2 subjects in the Ramelteon group completed the study. The 1 subject in the placebo group did not complete the study.||units on a scale||Standard Deviation|Mean
789907|NCT00869167|Primary|Pittsburgh Sleep Quality Index|"The change in ISI and PSQI from baseline to end of study will be compared between the two groups.
PSQI has a score range of 0-21, with lower the number being less sleep disturbances ISI has a score range of 0-28, with lower score meaning less insomnia symptoms"|baseline and post-treatment (at end of 5 weeks)|The 2 subjects in the Ramelteon group completed the study. The 1 subject in the placebo group did not complete the study.||units on a scale||Standard Deviation|Mean
789908|NCT00869258|Primary|Conversion Rate of Inoperable to Operable|Data was not analyzed because original PI left institution before data analysis was completed.|10 weeks||||||
789909|NCT00869323|Secondary|Overall Survival||at 2 years|||participants|||Number
789910|NCT00869323|Secondary|Relapse-free Survival||at 2 years|||participants|||Number
789911|NCT00869323|Secondary|Time to Treatment Failure||Day 1 to Time of Disease Progression|Two participants had a complete response at the time they completed the study and were not included in this outcome measure.||months|||Number
789912|NCT00869323|Secondary|Remission Duration Among Patients Who Respond to Treatment||Day 1 to 8 Months Post Treatment|Both of the participants who responded to treatment were in remission at last contact or death.||months||Full Range|Median
789913|NCT00869323|Primary|Number of Patients With Overall (Complete and Partial) Response Rates||Day 1 to 2 Years Post Treatment|||participants|||Number
789914|NCT00869349|Secondary|Self-Compassion|Change in the Neff Self Compassion scale from baseline to 21-months. This is a 26-item scale. The total self-compassion score ranges from 0 (no self-compassion) - 30 (high self-compassion). Reference: Neff, K.D. (2003). Development and validation of a scale to measure self-compassion. Self and Identity, 2, 223-250|21 months|Data reported on per-protocol analysis. Sensitivity analysis was performed to evaluate robustness of analyses.||units on a scale||Standard Deviation|Mean
789915|NCT00869349|Secondary|Depression|"Change in the Beck Depression Scale from baseline to 21-months. The BDI-II (Reference: BDI- II Manual by Aaron T. Beck, Robert A. Steer, and Gregory K. Brown) is a 21-item scale for measuring negative attitudes about the future. Add up each of the items marked in the direction keyed for hopelessness to get a total score.
Each of 21 items is summed to give single score for BDI-II.
There is 4-point scale ranging from 0 - 3. On 2 items (16, 18)
There are 7 options to indicate either increase or decrease of appetite and sleep. These are still scored 0 - 3 - answers are 0,1a,1b,2a,2b,3a,3b.
Cut score guidelines for the BDI-II are given with recommendation that thresholds be adjusted based on the characteristics of the sample, and the purpose for use of the BDI-II.
0 - 13 minimal 14 - 19 mild 20 - 28 moderate 29 – 63 severe"|21 months|Data reported on per-protocol analysis. Sensitivity analysis was performed to evaluate robustness of analyses.||units on a scale||Standard Deviation|Mean
789916|NCT00869349|Primary|RADAI Disease Activity Score|"Change in self-assessed disease activity from baseline to 21-months. Total RADAI score is 0-10 with 0 indicating no/low self-assessed disease activity and 10 indicating high self-assessed disease activity.
Reference: Stucki G, Liang M, Stucki S, Bruhlmann P, Michel BA. A self-administered rheumatoid arthritis disease activity index (RADAI) for epidemiological research. Psychometric properties and correlation with parameters of disease activity. Arthritis Rheum. 38;795-98,1995"|21 months|Data reported on per-protocol analysis. Sensitivity analysis was performed to evaluate robustness of analyses.||units on a scale||Standard Deviation|Mean
789917|NCT00869362|Secondary|Average Intervention Effect Over 12 Months After Hospital Discharge||12 months from discharge|||HbA1c, %||Standard Error|Mean
789918|NCT00869362|Primary|Hemoglobin A1c|Change in glycemic control measured by HbA1c change baseline to 6 months|6 months from discharge|||HbA1c, %||Standard Deviation|Mean
789919|NCT00869375|Primary|Incidence of Bleeding Complications||24 hours after the procedure|||participants|||Number
789920|NCT00869375|Primary|Immediate Distal Embolization Detected by Angiographic and/or Clinical Evidence||24 hours after the procedure|||participants|||Number
789921|NCT00869401|Secondary|Objective Response|Objective response to treatment will be determined by a combination of the results of neurological exam and the MRI and/or CT measurement of the tumor at each evaluation as is used for all NCCTG neuro-oncology trials. The proportion of patients in each response category will be summarized. Only phase II patients were evaluated for response.|Up to 5 years post treatment|Participants that have at least one disease evaluation for assessing best response to treatment.||Proportion of participants|||Number
789922|NCT00869401|Secondary|Progression-free Survival|Progression-free survival (PFS) is defined as the time from study registration to the date of first observation of disease progression or death due to any cause (whichever comes first). If a patient has not progressed or died, progression-free survival is censored at the time of last follow-up. Only Phase II patients were evaluated for Progression-free survival|Up to 5 years post treatment|All patients meeting the eligibility criteria that have signed a consent form and begun treatment will be considered evaluable||Months||95% Confidence Interval|Median
790278|NCT00871715|Secondary|National Institute of Health Stroke Scale (NIHSS)|Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.|Baseline to 1 year post-randomization||08/2017||||
789923|NCT00869401|Primary|The Number of Dose Limiting Toxicities(DLT) in Order to Determine Maximum Tolerable Dose(MTD) of Dasatinib Combined With Radiation and Temozolomide in This Patient Population.|Doselimiting toxicity will be defined as: Adverse event at least possibly related to the study medication. All by CTCAE v3.0 criteria: Greater than or equal to grade 3: diarrhea or skin rash or desquamation or (other) clinically relevant non-hematological adverse event or non-hematologic adverse event at least possibly due to drug therapy. Or greater than or equal to grade 4: neutropenia or leukopenia or thrombocytopenia or radiation dermatitis or hematologic adverse event OR failure to administer greater than 75% of dasatinib TMZ or interruption of RT for more than 5 days due to adverse events.OR severe acute central nervous system deterioration attributable to TMZ, RT and or dasatinib which cannot be controlled with corticosteroid administration. The MTD for this study will be defined as the highest safely tolerated dose level where at most 1 out of 6 patients experience DLT with the next higher dose having at least 2 patients out of a maximum of 6 patients experience DLT.|Every cycle from first dose to end of rest period prior cycle 3|Only Phase I patients were evaluated for maximum tolerable dose.||participants with Dose Limiting Toxicits|||Number
789924|NCT00869401|Primary|Overall Survival|Overall survival (OS) is the primary endpoint and is defined as the time from study registration to time of death due to any cause. All patients who meet the eligibility criteria, have signed a consent form, and have received at least one dose of the regimens will be considered evaluable. Patients who are lost to follow-up will be censored at the date of their last follow-up. Patients still alive at the time of analysis will be censored. Only Phase II was evaluated for survival|Up to 5 years post treatment|||Months||95% Confidence Interval|Median
789925|NCT00869414|Primary|Change in the Mean Minutes Per 24 Hour Day in the Hyperglycemic Range of > 180 mg/dL.||6 weeks|This study was prematurely terminated because the P.I. is deceased. The data for the Outcome Measures (if collected) is unknown since no data are available|||||
789926|NCT00869414|Primary|Time Spent (Mean Number of Minutes Per 24 Hour Day) in Hypoglycemic Range (<70mg/dl)||6 weeks|This study was prematurely terminated because the P.I. is deceased. The data for the Outcome Measures (if collected) is unknown since no data are available.|||||
789927|NCT00869518|Secondary|Recurrent Skin and Skin Structure Infections (SSTI)|recurrent SSTI was by self-report and exam, followed until positive colonization|up to 30 days following completion of treatment|participants were followed until colonization; therefore, no participants were followed past 30 days||participants|||Number
789928|NCT00869518|Secondary|Eradication of S. Aureus Colonization|Eradication was measured by performing cultures for S aureus at the nose, throat, and groin|60 days following completion of treatment|Participants were colonized at day 30 (i.e. S. Aureus not eradicated) and were not checked again for follow-up.|||||
789929|NCT00869518|Secondary|Eradication of S. Aureus Colonization|Eradication was measured by performing cultures for S aureus at the nose, throat, and groin|7 days following completion of treatment|||participants|||Number
789930|NCT00869518|Primary|Eradication of S. Aureus Colonization|Eradication was measured by performing cultures for S aureus at the nose, throat, and groin|30 days following completion of treatment|||participants|||Number
789931|NCT00869557|Secondary|The Percentage of Participants With Virologic Success at Weeks 24 and 48 Using FDA-Defined Snapshot Analysis and HIV-1 RNA Less Than 50 Copies/mL|The percentage of participants with virologic success at Weeks 24 and 48 assessed using the FDA-defined snapshot analysis for an HIV-1 RNA cutoff of 50 copies/mL was summarized.|Baseline to Weeks 24 and 48|ITT analysis set||percentage of participants|||Number
789932|NCT00869557|Secondary|Change From Baseline in CD4 Cell Count at Week 48|Change = Week 48 value minus baseline value|Baseline to Week 48|ITT analysis set; M = E analysis (all missing data were excluded from the analysis).||cells/µL||Standard Deviation|Mean
789933|NCT00869557|Secondary|Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 24|Change = Week 24 value minus baseline value|Baseline to Week 24|ITT analysis set. M = E analysis (all missing data were excluded from the analysis).||cells/µL||Standard Deviation|Mean
789934|NCT00869557|Secondary|Change From Baseline in HIV-1 RNA (log_10 Copies/mL)|Change = Week 24 or 48 value minus baseline value|Baseline to Weeks 24 and 48|ITT analysis set; The missing = excluded (M = E) analysis method was used in which all missing data were excluded from the analysis.||log_10 copies/mL||Standard Deviation|Mean
789935|NCT00869557|Secondary|The Percentage of Participants With HIV-1 RNA Less Than 50 Copies/mL at Week 48|The percentage of participants with plasma HIV-1 RNA < 50 copies/mL at Week 48 was summarized.|Week 48|ITT analysis set; M = F analysis (all missing data were considered as failure [HIV-1 RNA ≥ 50 copies/mL]).||percentage of participants|||Number
789936|NCT00869557|Primary|The Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) Less Than 50 Copies/mL at Week 24|The percentage of participants with plasma HIV-1 RNA < 50 copies/mL at Week 24 was summarized.|Week 24|ITT analysis set (all participants who were randomized into the study and received at least 1 dose of study drug). The missing = failure (M = F) analysis method was used in which all missing data were considered as failure (HIV-1 RNA ≥ 50 copies/mL).||percentage of participants|||Number
789937|NCT00869609|Secondary|Change in Waist Circumference|Waist circumference was measured at the midpoint between the lower rib margin and the iliac crest; the measurement was repeated twice and the average computed.|Measured at 8 months post intervention and 4 months post-randomization to maintenance group|Participants with relevant medication changes were excluded.||inches||Standard Deviation|Mean
789938|NCT00869609|Secondary|Change in Diastolic Blood Pressure|Blood pressure was measured in a sitting position in the right arm after resting for five minutes. First appearance and last heard (phase V) Korotkoff's sounds were used to define the pressure readings; the measures were repeated twice with a thirty second wait between each reading.|Measured at 8 months post intervention and 4 months post-randomization to maintenance group|Participants with relevant medication changes were excluded.||mmHg||Standard Deviation|Mean
789939|NCT00869609|Secondary|Change in Systolic Blood Pressure|Blood pressure was measured in a sitting position in the right arm after resting for five minutes. First appearance and last heard (phase V) Korotkoff's sounds were used to define the pressure readings; the measures were repeated twice with a thirty second wait between each reading.|Measured at 8 months post intervention and 4 months post-randomization to maintenance group|Participants with relevant medication changes were excluded.||mmHg||Standard Deviation|Mean
789940|NCT00869609|Secondary|Change in Glycosylated Hemoglobin A1c (HbA1c)|Collected via venous blood draw, the HbA1c level reflects glucose concentration over the previous period (approximately 8-12 weeks, depending on the individual) and provides an indication of long-term glycemic control.|Measured at 8 months post intervention and 4 months post-randomization to maintenance group|Participants with relevant medication changes were excluded.||percentage of glycosylated hemoglobin||Standard Deviation|Mean
789941|NCT00869609|Secondary|Change in Fasting Glucose|Fasting plasma glucose was measured after at least an eight-hour fast using the Cholestech LDX System by a certified research assistant.|Measured at 8 months post intervention and 4 months post-randomization to maintenance group|Participants with relevant medication changes were excluded.||mg/dl||Standard Deviation|Mean
789942|NCT00869609|Secondary|Change in Triglycerides|Triglycerides were measured after at least an eight-hour fast using the Cholestech LDX System by a certified research assistant.|Measured at 8 months post intervention and 4 months post-randomization to maintenance group|Participants with relevant medication changes were excluded.||mg/dl||Standard Deviation|Mean
789943|NCT00869609|Secondary|Change in LDL Cholesterol|Low-density lipoprotein (LDL) cholesterol was measured after at least an eight-hour fast using the Cholestech LDX System by a certified research assistant.|Measured at 8 months post intervention and 4 months post-randomization to maintenance group|Participants with medication changes relevant to the outcome were excluded.||mg/dl||Standard Deviation|Mean
789944|NCT00869609|Secondary|Change in HDL Cholesterol|High-density lipoprotein (HDL) cholesterol was measured after at least an eight-hour fast using the Cholestech LDX System by a certified research assistant.|Measured at 8 months post intervention and 4 months post-randomization to maintenance group|Participants with medication changes relevant to the outcome were excluded.||mg/dl||Standard Deviation|Mean
789945|NCT00869609|Secondary|Change in Total Cholesterol|Total cholesterol was measured after at least an eight-hour fast using the Cholestech LDX System by a certified research assistant.|Measured at 8 months post intervention and 4 months post-randomization to maintenance group|Participants with medication changes relevant to the outcome were excluded.||mg/dl||Standard Deviation|Mean
789946|NCT00869609|Primary|Change in Weight|Weight was measured twice without shoes with the average computed; participants were asked to remove their shoes at each measure.|Measured at 8 months post intervention and 4 months post-randomization to maintenance group|Intention to treat analyses were performed; for those with missing weights at the post-intervention, 8 and 12 month visits, the last documented observation was carried forward. This information was available from the session data, where weight was collected weekly.||pounds||Standard Deviation|Mean
789947|NCT00869622|Secondary|Vertebral Fractures||2 years|||Vertebral Fractures|||Number
789948|NCT00869622|Primary|Changes in Bone Mineral Density|"Patients with a T-Score of > -2.5 were randomized into two possible arms. A bisphosphonate group received 35mg risedronate weekly while another group received an identical placebo tablet weekly. Both groups received supplemental calcium and vitamin D.
Enrolled patients had bone density measurements of bilateral proximal femur, A-P lumbar spine, total body, forearm and L-P spine. All measurements were performed on a GE Lunar Bone Densitometer (iDXA) instrument. Measurements of 25-hydroxy vitamin D, NTX , serum calcium and blood chemistries occurred at scheduled intervals."|2 years|The study design involved 80 veterans with epilepsy who were treated with phenobarbital, phenytoin, carbamazepine and sodium valproate. This is a prospective study in which 80 patients who have been on phenytoin, phenobarbital, carbamazepine or sodium divalproex for at least 2 years were enrolled.||g/cm2||Standard Deviation|Mean
789949|NCT00869778|Secondary|Change From Baseline by Visit for Serum HBV DNA|Measuring the change in value of each visit viewpoints HBV DNA titers decreased compared with baseline values|week 12, 28, 32, 40, 52, 64, 76|Intent-to-treat population||IU/mL||Standard Deviation|Mean
789950|NCT00869778|Secondary|The Proportion of Patients With Serum HBV DNA Level < 29300 IU / ml;||week 12, 28, 32, 40, 52, 64, 76|Intent-to-treat population||percentage of participants|||Number
789951|NCT00869778|Secondary|The Proportion of Patients With Serum HBV DNA Load Decrease Equal or Greater Than 2 Log Scale;||week 12, 28, 32, 40, 52, 64, 76|Intent-to-treat population||percentage of participants|||Number
789952|NCT00869778|Secondary|Change From Baseline by Visit for HBeAg Titer|Measuring the change in value of each visit viewpoints HBeAg titers decreased compared with baseline values|at week 12, 28, 32, 40, 52, 64, 76.|Intent-to-treat population||IU/mL||Standard Deviation|Mean
789953|NCT00869778|Secondary|The Proportion of Patients With Positive Anti-HBe||at week 12, 28, 32, 40, 52, 64, 76.|Intent-to-treat population||percentage of participants|||Number
789954|NCT00869778|Secondary|The Proportion of Patients With Both Negative HBeAg and HBeAb;||at week 12, 28, 32, 40, 52, 64, 76.|Intent-to-treat population||percentage of participants|||Number
789955|NCT00869778|Secondary|Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 12,28,32,40,52,64,76||week 12, 28, 32, 40, 52, 64, 76|Intent-to-treat population||percentage of participants|||Number
789956|NCT00869778|Secondary|The Proportion of Patients With Serum HBV DNA Load Decrease Equal or Greater Than 1 Log Scale;||week 12, 28, 32, 40, 52, 64, 76|Intent-to-treat population||percentage of participants|||Number
789957|NCT00869778|Secondary|Percentage of Participants With HBeAg Seroconversion at Weeks 12, 28, 32, 40, 52, 64, 76|HBeAg seroconversion=HBeAg loss and presence of hepatitis B e antibody (HBeAb). HBeAg is a hepatitis B viral protein and is an indicator of active viral replication|serology response at week 12, 28, 32, 40, 52, 64, 76|Intent-to-treat population||percentage of participants|||Number
789958|NCT00869778|Primary|Percentage of Participants With HBeAg Seroconversion at Endpoint .|"Primary endpoint data were summarised under End of Study,using the last available post-baseline observation(Last Observation Carried Forward,LOCF)"|Endpoint(LOCF), up to 76 Weeks|Intention-To-Treat Population||percentage of participants|||Number
789959|NCT00869791|Secondary|"Off Time Hours Reported by Subjects Using Parkinson's Patient Diary"|Subjects recorded state of ”OFF” time using the Parkinson's Patient Diary|Last 3 days of each treatment period, every 30 minutes over a 24-hour day beginning at 6:00 AM|All treated patients||hours||Standard Deviation|Mean
789960|NCT00869791|Secondary|Result Summary of Day 1 Dyskinesia Evaluated by Investigator Assessment for Each Treatment Period|"To determine 8h efficacy on Day 1 the on site investigator assessments of ON, OFF and state of dyskinesia for each subject was collected predose (-1, -0.5, and 0 hours) every 30 min for up to 8 hours after dosing . For all subjects duration of (1) OFF time (2) ON time without dyskinesia, (3) ON time with non-troublesome dyskinesia and (4) ON time with troublesome dyskinesia was calculated for both treatments. Definition of “ON” was based on a 20% change from predose measure, and the results were analyzed in the standard manner of a two way crossover design. The trial inclusion criteria included ability of subject to differentiate “ON” state from “OFF” state per investigator’s assessment."|Predose and then every 30 min upto 8 h after dosing on Day of 1 of each treatment period|For determining motor assessment of dyskinesia evaluated by investigator assessment a mixed-effect model was used with treatment, sequence, and period as factors and subjects within sequence as error term. The primary analysis was performed on the average of all times collected half hourly. Data for two patients was not collected, N25 instead of 27||Hours||Standard Deviation|Mean
789961|NCT00869791|Secondary|8-Hour Efficacy Using Day 1 Unified Parkinson’s Disease Rating Scale Part III Score|To determine efficacy on Day 1 the UPDRS (unified Parkinson's disease rating) Part III score, a clinician-scored measure of motor function, was collected immediately predose and 1, 2, 3, 4, 5, 6, 7 and 8 h post dose. The UPDRS Part III motor exam analyzes multiple motor functions like speech, facial expression, tremor, rigidity, movement, posture, gait etc. Each parameter is assigned values from 0 to 4, with 0 being normal and 4 being the most affected. The total range is 0 - 108, with lower scores indicating a better outcome.The average of post dose was calculated for day 1.|Pre dosing and at hourly intervals through the 8-hour measurement period on day 1|Analysis of covariance was the primary analysis conducted on the mean UPDRS Part III across the 8-hour measurement period, with the predose UPDRS Part III value as a covariate. This analysis was repeated at each timepoint for completeness.||UPDRS Part III Motor Score||Standard Deviation|Mean
789962|NCT00869791|Secondary|8-Hour Efficacy Using Day 1 Tapping|"Improvement in Tapping: has been used as a surrogate endpoint for assessing subject being “On. Finger Tapping: the number of times the subject could tap two counter keys 20 cm apart alternately in 1 minute with the most affected arm assessed every 30 minutes on Day 1. Subjects performed the 60-second tapping measurement three times prior to dosing in the clinic, and at half-hour intervals through the 8-hour measurement period on Day 1 of each treatment period. More hours “On” during treatment represented better outcome. For the Tapping measurement, the protocol defined a 20% change from the average of the predose measurements as the time to “On.” Each half-hour interval counted as 0.5 hour. Any measurement below a 20% improvement was considered time “Not On.” If patient required redosing then primary analyses adjusted for redosing in calculating the results."|Day 1 of each treatment period - three times prior to dosing in the clinic, and at half-hour intervals through the 8-hour measurement period|Analysis of covariance was the primary analysis conducted on the mean total Taps across the 8-hour measurement period, with the average of the three predose Tapping measurement values as a covariate.||Hours||Standard Deviation|Mean
789963|NCT00869791|Primary|Pharmacokinetics Measurements to Determine Area Under the Concentration-time Curve for the Dosing Interval for LD and CD Concentrations From Blood Collected Pre-dose and at Different Time Points on Day 1 and Day 8 of Periods 1 and 2 of Treatment Arms.|For both treatment arms: Sequence 1 (IPX066, Washout, then IR CD-LD) and Sequence 2 (IR CD-LD, Washout, IPX066), blood samples for measurement of LD and CD plasma concentrations were collected pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, and 8 hours after dosing on Day 1 (referred to as Single-Dose data); and at pre-dose, 0.5, 1,1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours after dosing on Day 8 (referred to as Multiple-Dose data). Area under the concentration-time curve for the dosing interval (AUC Tau) in hour*nanogram/milliliter was estimated using Single-Dose data and Multiple-Dose data.|Day 1 and on Day 8 after a week of intervention in each treatment arm: Arm 1 (IPX066 first, washout, then CD-LD IR) and Arm2 (CD-LD IR first, washout, then IPX066|The study was designed to assess the single and multiple-dose PK and PD of IPX066 and IR CD-LD in subjects with advanced PD. 14 subjects first received IPX066 (Period 1), then IR CD-LD (Period 2). 13 Subjects first received IR CD-LD (Period 1), then IPX066 (Period 2). All 27 subjects that were treated in the study were included in the PK analyses.||hour*nanogram/milliliter||Standard Deviation|Mean
789964|NCT00869791|Primary|Pharmacokinetics Measurements to Determine Tmax for Levodopa and Carbidopa Plasma Concentrations From Samples Collected Pre-dose and at Different Time Points on Day 1 and Day 8 of Periods 1 and 2 of Both Treatment Arms.|For both treatment arms: Sequence 1 (IPX066, Washout, then IR CD-LD) and Sequence 2 (IR CD-LD, Washout, IPX066), blood samples for measurement of LD and CD plasma concentrations were collected pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, and 8 hours after dosing on Day 1 (referred to as Single-Dose data); and at pre-dose, 0.5, 1,1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours after dosing on Day 8 (referred to as Multiple-Dose data). Time of maximum drug concentration (Tmax in hours) was estimated using Single-Dose data and Multiple-Dose data.|Day 1 and on Day 8 after a week of intervention in each treatment arm: Arm 1 (IPX066 first, washout, then CD-LD IR) and Arm2 (CD-LD IR first, washout, then IPX066|The study was designed to assess the single and multiple-dose PK and PD of IPX066 and IR CD-LD in subjects with advanced PD. 14 subjects first received IPX066 (Period 1), then IR CD-LD (Period 2). 13 Subjects first received IR CD-LD (Period 1), then IPX066 (Period 2). All 27 subjects that were treated in the study were included in the PK analyses.||Hours||Standard Deviation|Mean
789975|NCT00869960|Primary|Tenofovir Systemic Exposure During the Luteal Phase (Days 20-25 After Menses)|Systemic exposure determined by area under the concentration time curve was measured by blood drawn for PK assessment at the following times: 0 (time of dose), 0.5, 1, 2, 4,6, 8, 12 and 24 hours. The Luteal phase starts on day 14 of the menstrual cycle when estrogen and progesterone levels are beginning to increase. This lasts 14 days or until Day 1 of the Follicular phase. Dose administration and PK during the Luteal phase, would have been drawn on day 20, 21, 22, 23, 24 and 25 start of Follicular phase).|between time of dosing tp 24 hours after dose administration|The number was determined based upon the those women who completed the study.||mg*h/L||Standard Deviation|Mean
789965|NCT00869791|Primary|Pharmacokinetics Measurements to Determine Cmax for Carbidopa (CD) and Levodopa (LD) Plasma Concentrations From Samples Collected Pre-dose and at Different Time Points on Day 1 and Day 8 of Periods 1 and 2 of Both Treatment Arms.|For both treatment arms: Sequence 1 (IPX066, Washout, then IR CD-LD) and Sequence 2 (IR CD-LD, Washout, IPX066), blood samples for measurement of LD and CD plasma concentrations were collected pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, and 8 hours after dosing on Day 1 (referred to as Single-Dose data); and at pre-dose, 0.5, 1,1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours after dosing on Day 8 (referred to as Multiple-Dose data). Maximum (peak) drug concentration (Cmax in nanograms/milliliter) was estimated using Single-Dose data and Multiple-Dose data.|Day 1 and on Day 8 after a week of intervention in each treatment arm: Arm 1 (IPX066 first, washout, then CD-LD IR) and Arm 2 (CD-LD IR first, washout, then IPX066)|The study was designed to assess the single and multiple-dose PK and PD of IPX066 and IR CD-LD in subjects with advanced PD.14 subjects first received IPX066 (Period 1), then IR CD-LD (Period 2). 13 Subjects first received IR CD-LD (Period 1), then IPX066 (Period 2). All 27 subjects that were treated in the study were included in the PK analyses.||nanogram/milliliter||Standard Deviation|Mean
789966|NCT00869947|Secondary|Trailing Leg Step-to-step Transition Work|We calculated step-to-step transition work, the work done by each individual leg on the center of mass during transitions, using the individual limbs method described by Donelan et al. 2002. Trailing leg step-to-step transition work quantifies the amount of push-off work done by the trailing leg when both feet are on the ground during walking. Work (J) is normalized to each subject's mass (kg).|1 year|||J/kg||Standard Error|Mean
789967|NCT00869947|Secondary|Preferred Walking Velocity|We determined preferred walking velocity by incrementally increasing and decreasing treadmill velocity until each participant ascertained the velocity that they felt most comfortable.|1 year|||m/s||Standard Deviation|Mean
789968|NCT00869947|Primary|Metabolic Cost of Transport|We measured and compared gross rates of oxygen consumption and carbon dioxide production using a portable metabolic analysis system (Cosmed K4b2, IT) while participants walked at five constance velocities (0.75, 1.00, 1.25, 1.50 and 1.75 m/s) on a level treadmill (SoleFitness F85). We calculated average steady-state metabolic power in Watts (W) from 4-6 min of each trial using a standard equation. Then, we divided the metabolic power by each participant's weight and velocity to calculate the metabolic cost of transport (J/Nm).|1 year|||J/Nm||Standard Deviation|Mean
789969|NCT00869960|Primary|Ritonavir Systemic Exposure During the Luteal Phase (Days 20-25 After Menses)|Systemic exposure determined by area under the concentration time curve was measured by blood drawn for PK assessment at the following times: 0 (time of dose), 0.5, 1, 2, 4,6, 8, 12 and 24 hours. The Luteal phase starts on day 14 of the menstrual cycle when estrogen and progesterone levels are beginning to increase. This lasts 14 days or until Day 1 of the Follicular phase. Dose administration and PK during the Luteal phase, would have been drawn on day 20, 21, 22, 23, 24 and 25 start of Follicular phase).|Between time of dosing to 24 hours after dose administration|The number was determined based upon the those women who completed the study.||mg*h/L||Standard Deviation|Mean
789970|NCT00869960|Primary|Ritonavir Systemic Exposure During the Follicular Phase (Days 6-10 After Menses)|Systemic exposure determined by area under the concentration time curve was measured by blood drawn for PK assessment at the following times: 0 (time of dose), 0.5, 1, 2, 4,6, 8, 12 and 24 hours. The Follicular phase starts on day 1 of the menstrual cycle when estrogen and progesterone levels are lowest. this lasts 14 days. Dose administration and PK would have been drawn on day 6, 7, 8, 9, or 10 after Day 1 (start of Follicular phase).|Between time of dosing to 24 hours after dose administration|The number was determined based upon the those women who completed the study.||mg*h/L||Standard Deviation|Mean
789971|NCT00869960|Primary|Atazanavir Systemic Exposure During the Luteal Phase (Days 20-25 After Menses)|Systemic exposure determined by area under the concentration time curve was measured by blood drawn for PK assessment at the following times: 0 (time of dose), 0.5, 1, 2, 4,6, 8, 12 and 24 hours. The Luteal phase starts on day 14 of the menstrual cycle when estrogen and progesterone levels are beginning to increase. This lasts 14 days or until Day 1 of the Follicular phase. Dose administration and PK during the Luteal phase, would have been drawn on day 20, 21, 22, 23, 24 and 25 start of Follicular phase).|Between time of dosing to 24 hours after dose administration|The number was determined based upon the those women who completed the study.||mg*h/L||Standard Deviation|Mean
789972|NCT00869960|Primary|Atazanavir Systemic Exposure During the Follicular Phase (Days 6-10 After Menses)|Systemic exposure determined by area under the concentration time curve was measured by blood drawn for PK assessment at the following times: 0 (time of dose), 0.5, 1, 2, 4,6, 8, 12 and 24 hours. The Follicular phase starts on day 1 of the menstrual cycle when estrogen and progesterone levels are lowest. this lasts 14 days. Dose administration and PK would have been drawn on day 6, 7, 8, 9, or 10 after Day 1 (start of Follicular phase).|Between time of dosing to 24 hours after dose administration|The number was determined based upon the those women who completed the study.||mg*h/L||Standard Deviation|Mean
789973|NCT00869960|Primary|Emtricitabine Systemic Exposure During the Luteal Phase (Days 20-25 After Menses)|Systemic exposure determined by area under the concentration time curve was measured by blood drawn for PK assessment at the following times: 0 (time of dose), 0.5, 1, 2, 4,6, 8, 12 and 24 hours. The Luteal phase starts on day 14 of the menstrual cycle when estrogen and progesterone levels are beginning to increase. This lasts 14 days or until Day 1 of the Follicular phase. Dose administration and PK during the Luteal phase, would have been drawn on day 20, 21, 22, 23, 24 and 25 start of Follicular phase).|Between time of dosing to 24 hours after dose administration|The number was determined based upon the those women who completed the study.||mg*h/L||Standard Deviation|Mean
789974|NCT00869960|Primary|Emtricitabine Systemic Exposure During the Follicular Phase (Days 6-10 After Menses)|Systemic exposure determined by area under the concentration time curve was measured by blood drawn for PK assessment at the following times: 0 (time of dose), 0.5, 1, 2, 4,6, 8, 12 and 24 hours. The Follicular phase starts on day 1 of the menstrual cycle when estrogen and progesterone levels are lowest. this lasts 14 days. Dose administration and PK would have been drawn on day 6, 7, 8, 9, or 10 after Day 1 (start of Follicular phase).|Between time of dosing to 24 hours after dose administration|The number was determined based upon the those women who completed the study.||mg*h/L||Standard Deviation|Mean
790013|NCT00863746|Secondary|Time to Progression|Time to progression (TTP) was defined as the time from date of randomization to date of first observed disease progression (radiological or clinical, whichever is earlier).|From randomization of the first subject until 36 months later assessed every 6 weeks|Full Analysis Set (FAS)||Days||95% Confidence Interval|Median
789976|NCT00869960|Primary|Tenofovir Systemic Exposure During the Follicular Phase (Days 6-10 After Menses)|Systemic exposure determined by area under the concentration time curve was measured by blood drawn for PK assessment at the following times: 0 (time of dose), 0.5, 1, 2, 4,6, 8, 12 and 24 hours. The Follicular phase starts on day 1 of the menstrual cycle when estrogen and progesterone levels are lowest. this lasts 14 days. Dose administration and PK would have been drawn on day 6, 7, 8, 9, or 10 after Day 1 (start of Follicular phase).|between time of dosing to 24 hours after dose administered|The number was determined based upon the those women who completed the study.||mg*h/L||Standard Deviation|Mean
789977|NCT00863317|Primary|Duration of Cough||up to 4 weeks|||days||Inter-Quartile Range|Median
789978|NCT00863330|Primary|Primary Objective|Determine the ability of autologous cells infused with minimal in vitro culture in conjunction with high dose interleukin -2 (IL-2) following non-myeloablative lymphodepleting preparative regimen to mediate tumor regression in patients with metastatic melanoma.|4-6 weeks after completion of TIL|Study was terminated for administrative reasons. complete data was not collected and no data analysis was completed|||||
789979|NCT00863343|Primary|MSD Influenza B Test Results Against Culture and PCR|A nasal sample is tested on the MSD Influenza Test, which provides a positive or negative result. A separate nasal swab is tested by tissue cell culture, which provides a positive or negative result. These two results are then compared, and PCR is performed on discrepant results and used to reconcile differences.|1 day|||participants|||Number
789980|NCT00863343|Primary|MSD Influenza A Test Results Against Culture and PCR|A nasal sample is tested on the MSD Influenza Test, which provides a positive or negative result. A separate nasal swab is tested by tissue cell culture, which provides a positive or negative result. These two results are then compared, and PCR is performed on discrepant results and used to reconcile differences.|1 day|||participants|||Number
789981|NCT00863343|Primary|MSD Influenza B Test Results Against Cell Culture|A nasal sample is tested on the MSD Influenza Test, which provides a positive or negative result. A separate nasal swab is tested by tissue cell culture, which provides a positive or negative result. These two results are then compared, and PCR is performed on discrepant results and used to reconcile differences.|1 day|||participants|||Number
789982|NCT00863343|Primary|MSD Influenza A Test Results Against Cell Culture|A nasal sample is tested on the MSD Influenza Test, which provides a positive or negative result. A separate nasal swab is tested by tissue cell culture, which provides a positive or negative result. These two results are then compared.|1 day|per protocol||participants|||Number
789983|NCT00863356|Primary|Hemostasis Success|Successful hemostasis prior to leaving physician's office|From procedure to hemostasis.|All enrolled subjects||percentage of participants|||Number
789984|NCT00863356|Secondary|This Study Evaluates the Benefits Acquired by the Use This New Product in Terms of Presence/Absence of Post-packing Tissue Scarring. This Will be Accessed by Endoscopic Examination of the Nasal Cavity Following Removal of HemCon Material.||Removal: 48 hours. Follow-up: 1 week.||||||
789985|NCT00863356|Primary|This Study Evaluates the Efficacy of HemCon Hemostatic Agent in Control of Complicated Epistaxis in Terms of % Success of Hemostasis. Success Will be Defined as Achieving Active Control of Bleeding Before Patient Leaves the Physicians Office.||Removal: 48 hours. Follow-up: 1 week.||||||
789986|NCT00863434|Primary|Overall Survival||Every 3 months for 2 years, and then annually for 3 years|||months||Full Range|Median
789987|NCT00863434|Primary|Disease-free Survival||Every 3 months for 2 years, and then annually for 3 years|||months||Full Range|Median
789988|NCT00863434|Primary|Minimal Residual Disease as Assessed by Bone Marrow Flow Cytometry|Percent of white blood cells that are blasts in the bone marrow post-treatment.|Post-treatment|||percent of white blood cells||Full Range|Median
789989|NCT00863512|Primary|Overall Survival|Overall survival (OS) is defined as the time between formal registration and death from any cause. The median OS with 95% CI was estimated using the Kaplan-Meier method.|Up to 12 years|Study terminated prematurely with 34 participants recruited. Per protocol, 338 events were needed to conduct the primary analysis; therefore, the planned analyses was not performed due to a lack of events and a termination of data collection.|||||
789990|NCT00863551|Secondary|Percentage of Study Subjects With No Clinically Significant Effect on Neurocognitive Function as Measured by the Brief Visuospatial Memory Test-Revised (BVMT-R) Delayed Recall Score at Day 10 Post-Dose|The BVMT-R is an instrument used to measure visual learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and a yes/no delayed recognition trial. The delayed recall score, derived from the delayed recall trial, provides a measure of the patient’s recent memory. The total score ranges from 0 (no memory) to 12 (best memory). Due to technical problems associated with the administration of the test, the results were invalid.|Day 10|Intent-to-treat, which included all patients who started the study. Due to technical problems associated with the administration of the test, the results were invalid.||Percentage of Subjects|||Number
789991|NCT00863551|Secondary|Percentage of Study Subjects With No Clinically Significant Effect on Neurocognitive Function as Measured by the Brief Visuospatial Memory Test-Revised (BVMT-R) Total Score at Day 10 Post-Dose|The BVMT-R is an instrument used to measure visual learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition trial. The total recall score is the sum of 3 free recall learning trials, and reflects the patient’s ability to learn. The total score ranges from 0 (no memory) to 12 (best memory). Due to technical problems associated with the administration of the test, the results were invalid.|Day 10|Intent-to-treat, which included all patients who started the study. Due to technical problems associated with the administration of the test, the results were invalid.||Percentage of Subjects|||Number
789992|NCT00863551|Secondary|Percentage of Study Subjects With No Clinically Significant Effect on Neurocognitive Function Delayed Recall Score as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R) at Day 10 Post-Dose|The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition trial. The delayed recall score provides a measure of the patient’s recent memory. The total score ranges from 0 (no memory) to 12 (best memory).|Day 10|Intent-to-treat, which included all patients who started the study.||Percentage of Subjects|||Number
789993|NCT00863551|Secondary|Percentage of Study Subjects With No Clinically Significant Effect on Neurocognitive Function Total Recall Score as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R) at Day 10 Post-Dose|The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition. The total recall score was the sum of 3 ‘free recall’ learning trials, and reflects the patient’s ability to learn. The total score ranges from 0 (no memory) to 36 (best memory).|Day 10|Intent-to-treat, which included all patients who started the study.||Percentage of Subjects|||Number
789994|NCT00863551|Primary|Cerebral Spinal Fluid Levels of Trospium at Day 10, Hour 5|Cerebral spinal fluid levels of Trospium at day 10, hour 5. Cerebral spinal fluid was collected from each patient.|Day 10, Hour 5|Intent-to-treat, which included all patients who started the study.||Picograms per milliliter (pg/mL)||Standard Deviation|Mean
789995|NCT00863655|Secondary|Estradiol Plasma Concentrations|Compare estradiol concentrations from baseline to week 4 in both treatment arms.|Baseline, Week 4|Safety Set population consisted of all patients who received at least one dose of study treatment and who had at least one valid post-baseline safety assessment. Although the safety set was considered for the analysis (N), only participants (n) who had pre-dose & 2 hours post-dose values for the given time points were analyzed for that time point.||pg/mL||Standard Deviation|Mean
789996|NCT00863655|Secondary|Exemestane Concentrations at Week 4|Characterize the PK of exemestane in combination with or without everolimus using Cmin and C2h at week 4 in a small group of patients.|predose, 2 hours post-dose|Safety Set population consisted of all patients who received at least one dose of study treatment and who had at least one valid post-baseline safety assessment. Although the safety set was considered for the analysis (N), only participants (n) who had pre-dose & 2 hours post-dose values for the given time points were analyzed for that time point.||ng/mL||Standard Deviation|Mean
789997|NCT00863655|Secondary|Everolimus Concentrations at Week 4|Characterize the pharmacokinetics (PK) of everolimus in combination with exemestane using Cmin (pre-dose) and C2h (post-dose) at week 4 in a small group of patients.|pre-dose, 2 hours post-dose|Safety Set population consisted of all patients who received at least one dose of study treatment and who had at least one valid post-baseline safety assessment. Although the safety set was considered for the analysis (N), only participants (n) who had pre-dose & 2 hours post-dose values for the given time points were analyzed for that time point.||ng/mL||Standard Deviation|Mean
789998|NCT00863655|Secondary|Duration of Response (Among Participants With Best Overall Response of CR or PR) Estimated Per Kaplan-Meier|Duration of response of CR or PR based on investigator applies only to patients whose best overall response was CR or PR (RECIST 1.0). The start date was the date of first documented response (CR or PR) and the end date and censoring is defined the same as that for time to progression. Per RECIST criteria 1.0, CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters.|21 months|Randomized patients with best overall response of CR or PR.||Months||95% Confidence Interval|Median
789999|NCT00863655|Secondary|Proportion of Patients With Having no Overall Response Based on Investigator Assessment|overall response = complete response (CR) + partial response (PR) per RECIST 1.0 Time to overall response (CR or PR) based on investigator is the time between date of randomization/start of treatment until first documented response (CR or PR). This analysis included all patients/responders. Patients who did not achieve a confirmed PR or CR were censored at last adequate tumor assessment date when they did not progress. Per RECIST criteria 1.0, CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters.|2, 4, 6, 9 months|All randomized patients were included in the Full Analysis Set.||Proportion of patients||95% Confidence Interval|Number
790000|NCT00863655|Secondary|Patient-reported Outcomes (PROs): Time to Deterioration of PRO Scores Using Kaplan Meier - EORTC QLQ-C30|"The QLQ-C30 is composed of both multi-item scales and single-item measures. These include 5 functional scales, 3 symptom scales, a global health status - QoL scale, and 6 single items. Each of the multi-item scales includes a different set of items - no item occurs in more than 1 scale. All of the scales measures range in score from 0 to 100. A high scale score = higher response level. Thus a high score for a functional scale represents a healthy level of function, a high score for the global health status / QoL represents a high quality of life but a high score for a symptom scale / item represents a high level of symptomatology / problems. The principle for scoring these scales: 1.) Estimate the average of the items that contribute to the scale = raw score. 2.) Linear transformation to standardize the raw score, so that scores range from 0 to 100; a higher score represents a higher (better) level of functioning, or a higher (worse) level of symptoms."|Up to 21 months|All randomized patients were included in the Full Analysis Set.||Months||95% Confidence Interval|Median
790001|NCT00863655|Secondary|Proportion of Patients With no Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) Using Kaplan-Meier|The ECOG PS (Eastern Cooperative Oncology Group Performance Scale) is a standard criteria for measuring how treatment of cancer impacts level of functioning in terms of the ability to care for oneself, daily activity, & physical ability (walking, working, etc.). Scale score ranges:0 to 5, 5 being the worst. Scale index: 0: Fully active, able to carry on all pre-disease performance without restriction. 1: Restricted in physically strenuous activity but ambulatory & able to carry out work of a light or sedentary nature. 2: Ambulatory & capable of all self-care but unable to carry out any work activities. Up & about more than 50% of waking hours. 3: Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 - Dead. A deterioration of ECOG is an increase of 1 of the ECOG PS without improvement back to initial level at a subsequent time of measurement.|2, 4, 6, 9 months|All randomized patients were included in the Full Analysis Set.||Proportion of patients||95% Confidence Interval|Number
790014|NCT00863746|Secondary|Objective Tumor Response|Objective tumor response was defined as the proportion of patients whose best response was Complete Response [CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target)] or Partial Response [PR: at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD] over the whole duration of study.|From randomization of the first subject until 36 months later assessed every 6 weeks|Full Analysis Set (FAS)||Proportion of participants|||Number
790002|NCT00863655|Secondary|Clinical Benefit Rate (CBR)|CBR is defined as the percentage of patients with best overall response of either complete response (CR), a partial response (PR) or stable disease (SD) >= 24 weeks, according to RECIST 1.0. Per RECIST criteria 1.0, CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters; SD = Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD; PD = At least a 20% increase in the sum of the longest diameter of all measured target lesions, taking as reference the smallest sum of longest diameter of all target lesions recorded at or after baseline.|up to 21 months|All randomized patients were included in the Full Analysis Set.||Percentage of participants|||Number
790003|NCT00863655|Secondary|Overall Response Rate (ORR)|Overall response rate (ORR) is the percentage of patients with a best overall response of complete response (CR) or partial response (PR) according to RECIST 1.0. Per RECIST criteria 1.0, CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters.|up to 21 months|All randomized patients were included in the Full Analysis Set.||Percentage of participants|||Number
790004|NCT00863655|Secondary|Overall Survival (OS) by Median|Overall survival, the key secondary endpoint in this study, is defined as the time from date of randomization to the date of death due to any cause.|up to 53 months|All randomized patients were included in the Full Analysis Set.||Months||95% Confidence Interval|Median
790005|NCT00863655|Secondary|Overall Survival (OS) by Number of Deaths|Overall survival, the key secondary endpoint in this study, is defined as the time from date of randomization to the date of death due to any cause. If a patient is not known to have died, survival was censored at the date of last contact.|up to 53 months|All randomized patients were included in the Full Analysis Set.||Participants|||Number
790006|NCT00863655|Primary|Progression-free Survival (PFS) Based on Local Radiology Review of Tumor Assessments.|Progression-free survival, the primary endpoint in this study, is defined as the time from the date of randomization to the date of first documented radiological progression or death due to any cause. Disease progression was based on the tumor assessment by the local radiologist or investigator using RECIST 1.0 criteria. If a patient did not progress or known to have died at the date of the analysis cut-off or start of another antineoplastic therapy, the PFS date was censored to the date of last adequate tumor assessment prior to cut-off date or start of antineoplastic therapy. For patients with lytic or mixed (lytic+sclerotic) bone lesions, the following is considered progression: appearance of ≥1 new lytic lesions in bone; the appearance of ≥ new lesions outside of bone and unequivocal progression of existing bone lesions.|date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first, reported between day of first patient randomized up to about 19 months|All randomized patients were included in the Full Analysis Set.||months||95% Confidence Interval|Median
790007|NCT00863707|Primary|Number of Subject With Serious Treatment Emergent Adverse Events (TEAE)|"The data represents the numbers of subjects reporting Serious TEAEs.
TEAEs were defined as Adverse Events (AEs) starting or worsening after administration of the test drug."|24 hours post dose|The number of participants analyzed per arm represents Safety Analysis Set (SAF); all randomized subjects who received any amount of study drug.||Subjects|||Number
790008|NCT00863746|Secondary|Mean Change From Baseline in EuroQol-5D (EQ-5D) - VAS Score|A visual analogue scale (EQ VAS) used by patients to rate their current health state from 100 (best imaginable health state) to 0 (worst imaginable health state). The change of score ranges from -100 (high degree of worsening) to 100 (high degree of improvement)|Baseline and up to End of treatment (up to Cycle 41, 21 days per cycle)|Patient report outcomes (PRO) analysis set||Scores on a scale||Standard Deviation|Mean
790009|NCT00863746|Secondary|Mean Change From Baseline in EuroQol-5D (EQ-5D) - Index Score|The Euro-Qol 5D (EQ-5D) is a validated assessment tool of Health Related Quality of Life (HRQOL) and utilities consisting of 15 statements. Patients select those statements that best describe their current health state regarding mobility, self-care, usual activities, pain/discomfort, and anxiety/depression which is converted into a utility value. Range of scale is from -0.594 (worst possible health state) to 1 (perfect health) based on UK weights. The change of score ranges from -1.594 (high degree of worsening) to 1.594 (high degree of improvement).|Baseline and up to End of treatment (up to Cycle 41, 21 days per cycle)|Patient report outcomes (PRO) analysis set||Scores on a scale||Standard Deviation|Mean
790010|NCT00863746|Secondary|Mean Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) - Dyspnea|A clinically valid 13-item tool for assessing disease- and treatment-specific symptoms in lung cancer patients in clinical trials. The dyspnea subscale uses questions 3, 4 and 5 of the questionnaire. The scale ranges from 0 to 100. Higher score means higher level of symptomatology/problems. The change of score ranges from -100 (decrease in level of symptomatology/problems) to 100 (increase in level of symptomatology/problems).|Baseline and up to End of treatment (up to Cycle 41, 21 days per cycle)|Patient report outcomes (PRO) analysis set||Scores on a scale||Standard Deviation|Mean
790011|NCT00863746|Secondary|Mean Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) - Coughing Subscale|A clinically valid 13-item tool for assessing disease- and treatment-specific symptoms in lung cancer patients in clinical trials. The coughing subscale uses question 1 of the questionnaire. The scale ranges from 0 to 100. Higher score means higher level of symptomatology/problems. The change of score ranges from -100 (decrease in level of symptomatology/problems) to 100 (increase in level of symptomatology/problems).|Baseline and up to End of treatment (up to Cycle 41, 21 days per cycle)|Patient report outcomes (PRO) analysis set||Scores on a scale||Standard Deviation|Mean
790012|NCT00863746|Secondary|Mean Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire for Palliative Care (EORTC QLQ-C15-PAL) - Global Health Status|The EORTC QLQ-C15-PAL is an abbreviated 15-item version of the EORTC core quality of life questionnaire (EORTC QLQ-C30) developed for use in palliative care. The 'Global Health status' subscale consists of question 15 of the questionnaire. The score of 'Global Health status' ranges from 0 (very poor) to 100 (excellent). The change of score ranges from -100 (maximum degree of worsening) to 100 (maximum degree of improvement).|Baseline and up to End of treatment (up to Cycle 41, 21 days per cycle)|Patient report outcomes (PRO) analysis set||Scores on a scale||Standard Deviation|Mean
790015|NCT00863746|Secondary|Disease Control|Disease control (DC) was defined as the proportion of patients whose best response was Complete Response [CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target)] or Partial Response [PR: at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD] or Stable Disease [SD: steady state of disease which was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease (PD)].|From randomization of the first subject until 36 months later assessed every 6 weeks|Full Analysis Set (FAS)||Proportion of participants|||Number
790016|NCT00863746|Secondary|Progression-free Survival|Progression-free survival (PFS) was defined as the time from date of randomization to date of first observed disease progression (radiological or clinical, whichever is earlier) or death due to any cause, if death occurs before progression is documented. Progressive Disease (PD) is defined as at least a 20% increase in the sum of longest diameter (LD) of measured lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Appearance of new lesions will also constitute progressive disease. In exceptional circumstances unequivocal progression of a non-measured lesion may be accepted as evidence of disease progression.|From randomization of the first subject until 36 months later assessed every 6 weeks|Full Analysis Set (FAS)||Days||95% Confidence Interval|Median
790017|NCT00863746|Primary|Overall Survival|Overall survival (OS) was defined as the time from date of randomization to date of death due to any cause. Overall survival of subjects alive at the time of analysis will be censored at their last date of follow-up or database cut off date whichever came first.|From randomization of the first subject until 36 months later|Full Analysis Set (FAS)||Days||95% Confidence Interval|Median
790018|NCT00863798|Other Pre-specified|Discontinuation-Emergent Signs and Symptoms (DESS)|DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of new symptoms and old (but worse) symptoms that appeared during tapering of the test article. A higher score indicates more symptoms.|Week 8 to 10 (or ET)|Analysis included completers for exposure (those whose exposure duration was at least 53 days) among safety population. 'n' is participants who received drug and were evaluated for measure at timepoint for each group respectively.||Units on a scale||Standard Deviation|Mean
790019|NCT00863798|Other Pre-specified|Number of Participants With Categorical Scores on the C-SSRS at FOT Evaluation (Week 8 or ET)|C-SSRS mapped into C-CASA(1-7) to assess whether participant:completed suicide(1),suicide attempt(2)(response of “Yes” on “Actual Attempt”),preparatory acts toward imminent suicidal behavior (3)(“Yes” on “Preparatory Acts or Behavior”),suicidal ideation (4)(“Yes” on “Wish to be dead”,“Non-Specific Active Suicidal Thoughts”,“Active Suicidal Ideation with methods without Intent to Act or Some Intent to Act,without Specific Plan or with Specific Plan and Intent),any suicidal behavior or ideation,self-injurious behaviour(7)(“Yes” on “Has subject engaged in Non-suicidal Self-Injurious Behavior”).|Week 8 (or ET)|The safety population included all participants randomly assigned to treatment who had taken at least 1 dose of double-blind study drug.||Participants|||Number
790020|NCT00863798|Other Pre-specified|Percentage of Participants With Sexual Dysfunction at FOT Evaluation (Week 8 or ET)|ASEX scale includes 5 questions that evaluate sexual function exclusively during the week prior to completion in the following areas: libido, excitability and ability to reach orgasm. Sexual dysfunction=an ASEX total score of 19 or greater, or a score of 5 or greater on any item, or a score of 4 or greater on any 3 items. Participants who have had no sexual activity during the prior week were instructed to not complete questions 3 through 5.|Week 8 (or ET)|The safety population included all participants randomly assigned to treatment who had taken at least 1 dose of double-blind study drug.||Percentage of Participants|||Number
790021|NCT00863798|Other Pre-specified|Change From Baseline in WHO-5 Total Score at FOT Evaluation (Week 8 or ET)|WHO-5 evaluates positive psychological well-being. WHO-5 consists of 5 questions and each is rated on a 6-point scale. The total score ranges from 0 to 25 (0= worst possible quality of life; 25=best possible quality of life).|Baseline and Week 8 (or ET)|ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study drug, and had at least 1 primary efficacy evaluation after first dose of double-blind study drug. If participant had a missing value at any visit, LOCF method of imputation was used.||Units on a scale||Standard Error|Mean
790022|NCT00863798|Other Pre-specified|Change From Baseline in SDS at FOT Evaluation (Week 8 or ET)|SDS: a self-administered tools that measures functional impairment in 3 domains: Work/School, Social Life, and Family Life/Home Responsibilities. The participant rates the extent to which each of these domains is impaired by his/her symptoms using a 10 point visual analog scale: (0=not at all impaired, 10=extremely impaired) for a total maximum score of 30.|Baseline and Week 8 (or ET)|ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation,had taken at least 1 dose of double-blind study drug,had at least 1 primary efficacy evaluation after first dose of double-blind drug.'n' is participants who received drug and were evaluated for measure at timepoint for each group respectively.||Units on a scale||Standard Error|Mean
790023|NCT00863798|Other Pre-specified|Population Pharmacokinetics for Desvenlafaxine Plasma Concentrations|Relationship of demographic variables (age, gender, food, race, creatinine, aspartate aminotransaminase, alanine transaminase, bilirubin and concomitant medications) were examined by fitting measured DVS plasma concentrations to a 1 compartment model with first order absorption. Demographic variables were examined for clearance (CL/F), volume of distribution (V/F), Steady Area under Curve (AUC) using nonlinear mixed effects modeling. Final parameter estimates for demographic factors effecting CL/F, V/F and AUC were determined.|Week 2, 4 and 8 (or ET)|PK population; data was insufficient examine the effect of demographic variables on the PK of desvenlafaxine. Parameter values were calculated for variables altering CL/F, AUC and V/F. Population parameters from nonlinear mixed effects modeling were not summarized as descriptive statistics.||nanogram(ng)/mL||Standard Deviation|Mean
790024|NCT00863798|Secondary|Number of Participants With a Response on the CGI-I Score at FOT Evaluation (Week 8 or ET)|CGI-I responder was defined as a participant with a score of 1 (very much improved) or 2 (much improved) on the CGI-I. CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Week 8 (or ET)|ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study drug, and had at least 1 primary efficacy evaluation after first dose of double-blind study drug. If participant had a missing value at any visit, LOCF method of imputation was used.||Participants|||Number
790025|NCT00863798|Secondary|Number of Participants With a Response on the MADRS Score at FOT Evaluation (Week 8 or ET)|A MADRS responder was defined as a participant with a 50% or greater decrease from baseline in MADRS score. It measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Week 8 (or ET)|ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study drug, and had at least 1 primary efficacy evaluation after first dose of double-blind study drug. If participant had a missing value at any visit, LOCF method of imputation was used.||Participants|||Number
790026|NCT00863798|Secondary|Number of Participants in Remission Based on the HAM-D17 at FOT Evaluation (Week 8 or ET)|Remission was defined as a HAM-D17 score of less than or equal to 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe, for a maximum total score of 50.|Week 8 (or ET)|ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study drug, and had at least 1 primary efficacy evaluation after first dose of double-blind study drug. If participant had a missing value at any visit, LOCF method of imputation was used.||Participants|||Number
790027|NCT00863798|Secondary|Number of Participants With a Response on the HAM-D17 at FOT Evaluation (Week 8 or ET)|A HAM-D17 responder was defined as a participant with a 50% or greater decrease from baseline in HAM-D17 score. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe, for a maximum total score of 50.|Week 8 (or ET)|ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study drug, and had at least 1 primary efficacy evaluation after first dose of double-blind study drug. If participant had a missing value at any visit, LOCF method of imputation was used.||Participants|||Number
790028|NCT00863798|Secondary|Change From Baseline in HAM-D6 Total Score at FOT Evaluation (Week 8 or ET)|HAM-D6: a standardized, clinician-administered rating scale that assesses 6 items characteristically associated with major depression and is a subset of HAM-D17. HAM-D6 score ranges from 0-22. 0=none/absent and 22=most severe.The scale uses HAM-D17 items: 1, 2, 7, 8, 10 and 13. Item 13 is scored 0-2 and all others are scored 0-4.|Baseline and Week 8 (or ET )|ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study drug, and had at least 1 primary efficacy evaluation after first dose of double-blind study drug. If participant had a missing value at any visit, LOCF method of imputation was used.||Units on a scale||Standard Error|Mean
790029|NCT00863798|Secondary|Change From Baseline in MADRS Total Score at FOT Evaluation (Week 8 or ET)|MADRS measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline and Week 8 (or ET)|ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study drug, and had at least 1 primary efficacy evaluation after first dose of double-blind study drug. If participant had a missing value at any visit, LOCF method of imputation was used.||Units on a scale||Standard Error|Mean
790030|NCT00863798|Secondary|Change From Baseline in Mean CGI-S Score at FOT Evaluation (Week 8 or ET)|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected.|Baseline and Week 8 (or ET )|ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study drug, and had at least 1 primary efficacy evaluation after first dose of double-blind study drug. If participant had a missing value at any visit, LOCF method of imputation was used.||Units on a scale||Standard Error|Mean
790031|NCT00863798|Secondary|Number of Participants With Categorical Scores on CGI–Improvement (CGI-I) at FOT Evaluation (Week 8 or ET)|CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Week 8 (or ET)|ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study drug, and had at least 1 primary efficacy evaluation after first dose of double-blind study drug. If participant had a missing value at any visit, LOCF method of imputation was used.||Participants|||Number
790032|NCT00863798|Primary|Change From Baseline in HAM-D17 Total Score at Final On-therapy (FOT) Evaluation (Week 8 or ET)|HAM-D17: a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe, for a maximum total score of 50.|Baseline and Week 8 (or ET)|Intent-To-Treat (ITT) Population:all randomly assigned participants with baseline primary efficacy evaluation, had taken at least 1 dose of double-blind drug and 1 primary efficacy evaluation after first dose of double-blind drug. If participant had missing value at any visit, last observation carried forward (LOCF) method of imputation was used.||Units on a scale||Standard Error|Mean
790033|NCT00864032|Primary|Number of Dose Limiting Toxicities|"Number of dose limiting toxicities and number with adverse events.
Dose-escalation schedule comprising 6 to 12 patients (see schema). This sample size is based on a traditional 3+3 cohort design with escalating doses of sorafenib in combination with 50 Gy of conformal radiotherapy delivered in 25 fractions (200 cGy per fraction). Based on preclinical data regarding the radiobiology of sorafenib,33, 36 sorafenib will be initiated at a dose of 200 mg twice daily, followed by 200 mg Q AM/400 mg Q PM for the 2nd cohort, followed by 400 mg bid for the 3rd cohort. Since 400 mg bid is the well established MTD for sorafenib monotherapy in patients with renal cell carcinoma and hepatocellular carcinoma, the dose will not be escalated above this level even if DLT is not observed. Dose level escalation will be determined based on DLTs observed from initiation of sorafenib/RT until time of surgery."|Approximately 12 weeks|||DLTs|||Number
790034|NCT00864084|Primary|Standing Balance - Critical Point in Distance|Standing balance was measured using a force plate (AMTI, Watertown, MA, USA) from which centre of pressure (COP) trajectories were derived at a sampling frequency of 100Hz. Participants stood on the force plate during the following two conditions: normal stance (feet hip-width apart) with eyes open and eyes closed.|Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks|||cm||Standard Deviation|Mean
790035|NCT00864084|Primary|Standing Balance - Critical Point in Time|Standing balance was measured using a force plate (AMTI, Watertown, MA, USA) from which centre of pressure (COP) trajectories were derived at a sampling frequency of 100Hz. Participants stood on the force plate during the following two conditions: normal stance (feet hip-width apart) with eyes open and eyes closed.|Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks|||s||Standard Deviation|Mean
790036|NCT00864084|Secondary|Confidence in Disease Management|The COPD Self-Efficacy Scale evaluates level of confidence in ability to manage or avoid breathing difficulty during a range of situations such as feeling frustrated and lifting heavy objects {Wigal, 1991 #3}. Possible answers range from “very confident” (5 points) to “not at all confident” (1 point) and the average score per question is calculated. This scale has been shown to have excellent internal consistency and good test-retest reliability.|Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks|||scores on a scale||Standard Deviation|Mean
790037|NCT00864084|Secondary|Fear of Falling|"The Falls Efficacy Scale International (FESI) assesses fear of falling during a range of physical and social activities {Yardley, 2005 #1}. It asks about an individual’s concern about the possibility of following during participation in sixteen common activities, such as cleaning the house, ascending and descending stairs and walking in various environmental conditions. Answers range from 1, “not at all” concerned, to 4, “very concerned, on a 4-point scale, and score is calculated as the average response. This questionnaire has been shown to have excellent internal and test-retest reliability {Yardley, 2005 #1}."|Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks|||scores on a scale||Standard Deviation|Mean
790038|NCT00864084|Secondary|Balance Confidence|Activity-Specific Balance Confidence (ABC) scale measures balance confidence during sixteen activities of progressive difficulty, such as going up and down stairs, reaching for objects and walking in crowded areas {Powell, 1995 #5}. It asks subjects to rate their level of confidence in performing an activity without losing balance on an 11-point scale ranging from 0% (no confidence) to 100% (completely confident). The score is calculated as the average score for each item. This questionnaire has been shown to be sensitive to detect changes in function following rehabilitation {Myers, 1998 #6} and has proven internal consistency and test-retest reliability {Powell, 1995 #5}.|Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks|||units on a scale||Standard Deviation|Mean
790039|NCT00864084|Primary|Dynamic Balance|Dynamic balance was measured using the timed up and go (TUG) and Four Square Step Test (FSST). For the TUG, the time taken for the subject to stand from a chair, walk 3 m, turn around and return to the chair was recorded {Podsiadlo, 1991 #31}. Subjects were asked to do this as quickly and safely as possible. High test-retest reliability of the TUG has been reported in older community-dwelling individuals {Steffen, 2002 #34}. In the FSST, subjects were asked to step to four corners of a square in a clockwise and then counter-clockwise direction as quickly as possible {Dite, 2002 #1181}. The time taken to complete this circuit was recorded. This test has been shown to have high inter-rater and test-retest reliability {Dite, 2002 #1181}.|Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks|||seconds||Standard Deviation|Mean
790040|NCT00864084|Primary|Standing Balance - Sway Path|Standing balance was measured using a force plate (AMTI, Watertown, MA, USA) from which centre of pressure (COP) trajectories were derived at a sampling frequency of 100Hz. Participants stood on the force plate during the following two conditions: normal stance (feet hip-width apart) with eyes open and eyes closed.|Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks|||cm/s||Standard Deviation|Mean
790041|NCT00864123|Secondary|Adverse Symptom Checklist (ASC; Goodman, 2005).|This index assesses adverse side effects that have been associated with DCS, as well as other commonly used psychotropic agents (e.g., SRIs). There are no summary scales for this. Rather, it reflects the presence or absence of 30 potential side effects on a 0-3 scale (0=not at all, 1=slight, 2=moderate, 3=severe) that are associated with study interventions.|Baseline, mid-treatment, post-treatment|Number of participants experiencing an adverse effect related to study interventions. This is a simple frequency count.||participants|||Number
790042|NCT00864123|Secondary|Clinical Global Impression – Severity (CGI-S; National Institute of Mental Health, 1985). The CGI-S is a 7-point Clinician Rating of Severity of Psychopathology.|The CGI-S is a 7-point clinician rating of severity of psychopathology. Ratings range from 1 (“no illness”) to 7 (“extremely severe”). A single rating is chosen for the CGI-S; thus, there are no summary scales/scores.|Baseline, mid-treatment, post-treatment|||units on a scale||Standard Deviation|Mean
790043|NCT00864123|Primary|Children’s Yale-Brown Obsessive-Compulsive Scale (CY-BOCS; Scahill et al., 1997).|The CY-BOCS is a 10-item semi-structured measure of obsession and compulsion severity over the previous week. This measure served as the primary outcome index. Scores range from 0-40 with higher scores representing more severe symptoms.|Baseline, Mid-Treatment, Post-treatment|||units on a scale||Standard Deviation|Mean
790056|NCT00864253|Secondary|Pharmacokinetic Parameters||On Cycle 1, Day 1 blood samples were taken at 0.25, 3.5, and 24 hr post-infusion end of the initial dose|Patients randomized to receive ABI-007 treatment in Australia, Canada, Europe, United Kingdom and United States had the option to participate in sparse PK sampling in this study. Only 44 participants consented to participate, an insufficient number to support the planned population PK analysis hence these analyses were not performed|||||
790057|NCT00864253|Secondary|Nadir for the Hemoglobin Count Measurements|Maximal degree of myelosuppression during study drug dosing was represented by the nadir in hemoglobin count measurements over all treatment cycles.|Day 1 up to 106 weeks; up to data cut off 30 June 2012|Treated population = consisted of all randomized participants who received at least one dose of study drug and with at least one post-baseline central laboratory result were included.||g/L||Full Range|Median
790058|NCT00864253|Secondary|Nadir for Platelet Count Measurements.|Maximal degree of myelosuppression was represented by the nadir in platelet count measurements over all treatment cycles.|Day 1 up to 106 weeks; up to data cut off 30 June 2012|Treated population = consisted of all randomized participants who received at least one dose of study drug and with at least one post-baseline central laboratory result were included||10^9/L||Full Range|Median
790059|NCT00864253|Secondary|Nadir for White Blood Cells (WBCs) Measurements|Maximal degree of myelosuppression was represented by the nadir in white blood cells (WBCs) count measurements over all treatment cycles.|Day 1 up to 106 weeks; up to data cut off 30 June 2012|Treated population = consisted of all randomized participants who received at least one dose of study drug and with at least one post-baseline central laboratory result were included||10^9/L||Full Range|Median
790060|NCT00864253|Secondary|Nadir for the Absolute Neutrophil Count (ANC) Measurements|Maximal degree of myelosuppression during study drug dosing was represented by the nadir in ANC measurements over all treatment cycles.|Day 1 up to 106 weeks; up to data cut off 30 June 2012|Treated Population = consisted of all randomized participants who received at least one dose of study drug and with at least one post-baseline central laboratory result were included||10^9/L||Full Range|Median
790061|NCT00864253|Secondary|Number of Participants Experiencing Dose Reductions, or Dose Interruptions, or Dose Delays of Study Drug|The number of participants with dose reductions, dose interruptions and dose delays that occurred during the treatment period. Dose reductions, interruptions and delays are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities.|Maximum study drug exposure 106 weeks; data cut off 30 June 2012|Treated population||participants|||Number
790062|NCT00864253|Secondary|Summary of Treatment-emergent Adverse Events (AEs)|"A Treatment Emergent AE (TEAE) was any AE that began or worsened after the start of the study drug through 30 days after the last dose of study drug or end of study whichever is later. A treatment related toxicity was one considered by the investigator to be possibly, probably or definitely related to study drug. AE’s were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) V 3.0 criteria and the following scale:
Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life threatening, and Grade 5 = Death A SAE is any untoward medical occurrence at any dose that is fatal or life threatening, results in persistent or significant disability or incapacity; requires prolonged hospitalizations; is a congenital anomaly birth defect in the offspring of a patient, and conditions not included in the above that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above."|Maximum exposure to study drug was 106 weeks; up to data cut off of 30 June 2012|Treated Population = The Treated population consisted of all randomized participants who received at least one dose of study drug||participants|||Number
790063|NCT00864253|Other Pre-specified|Duration of Response (DOR) in Responding Participants|Duration of response (DOR) as measured by PFS based on radiological review for participants who achieved an objective confirmed response of CR or PR. DOR was defined as progression-free survival in responders, i.e. as the time between the start of a complete response (CR) or partial response (PR) and the start of progressive disease (PD) or participants death from any cause, whichever occurred first. Participants that did not have progression or had not died were censored at the last known time the participant was progression free. Participants that had initiated other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated. Complete response (CR) and partial response (PR) are defined in outcome #4. Progressive disease was defined as at least a 20% increase in the sum of the longest diameters of target lesions; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion.|up to data cut off 30 June 2012|ITT of participants with a confirmed complete or partial overall response||months||95% Confidence Interval|Median
790064|NCT00864253|Other Pre-specified|Percent of Participants With Stable Disease (SD) for ≥ 16 Weeks, or Confirmed Complete or Partial Response (i.e., Disease Control) Based on a Blinded Radiology Assessment of Response|"Disease control is stable disease (SD) for >=16 weeks + complete response (CR) + partial response (PR). See Outcome #4 for definitions of CR and PR.
RECIST defines SD for target lesions as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, no occurrence of progression disease for non-target lesions, and no new lesions."|Response assessment completed every 8 weeks until disease progression; up to data cut-off 30 June 2012|ITT||percent of participants|||Number
790065|NCT00864253|Other Pre-specified|Percent of Participants Who Achieve an Objective Confirmed Complete or Partial Response Based on Blinded Radiology Assessment of Response by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0|RECIST defines complete response (CR): The disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation. All sites must be assessed, including non-measurable sites, such as effusions, or markers. Disappearance of all non-target lesions. The normalization of tumor marker level confirmed at least 4 weeks after initial documentation. Partial response (PR): At least a 30% decrease in the sum of the longest diameters of target lesions, taking as a reference the baseline sum of the longest diameters confirmed at least 4 weeks after initial documentation. PR is also recorded when all measurable disease has completely disappeared, but a non-measurable component (i.e., ascites) is still present but not progressing. As well as persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits.|every 8 weeks; up to data cut off 30 June 2012|ITT||percentage of participants|||Number
794040|NCT00910299|Primary|Number of Participants With Composite Endpoint of Cardiovascular Death or Myocardial Infarction (MI)|The endpoint in this measure is a combination of cardiovascular death or MI.|Baseline through 6 months|Participants who were randomized.||participants|||Number
790066|NCT00864253|Other Pre-specified|Progression-free Survival (PFS) Based on Investigator Assessment Using RECIST Response Guidelines|PFS was defined as the time from the randomization date to the start of disease progression or patient death, whichever occurred first. Participants who did not have disease progression or had not died were censored at the last known time that the patient was progression free. In the event of palliative radiotherapy or surgery, they were censored at the last assessment where they were documented to be progression-free prior to the date of radiotherapy or surgery. In follow up, patients who began new anticancer therapy prior to documented progression were censored at the last assessment where they were documented as progression free. Those with two or more missing response assessments prior to a visit with documented disease progression (or death) were censored at the last visit where they were documented to be progression free.|Response assessments completed every 8 weeks until disease progression; up to data cut off 30 June 2012; 38 months|ITT||months||95% Confidence Interval|Median
790067|NCT00864253|Secondary|Participant Survival|Survival was defined as the time from the date of randomization to the date of death (any cause). Participants were censored at the last known time that they were alive.|Up to 38 months; Up to data cut off of 30 June 2012|Intent to treat population||months||95% Confidence Interval|Median
790068|NCT00864253|Primary|Progression Free Survival (PFS) Based on a Blinded Radiology Assessment of Response Using Response Evaluation Criteria in Solid Tumors (RECIST) Guidelines|PFS was defined as the time from the randomization date to the start of disease progression or patient death, whichever occurred first. Participants who did not have disease progression or had not died were censored at the last known time that the patient was progression free. In the event of palliative radiotherapy or surgery, they were censored at the last assessment where they were documented to be progression-free prior to the date of radiotherapy or surgery. In follow up, participants who began new anticancer therapy prior to documented progression were censored at the last assessment where they were documented as progression free. Those with two or more missing response assessments prior to a visit with documented disease progression (or death) were censored at the last visit where they were documented to be progression free. RECIST defines progressive disease as a ≥ 20% increase taking as reference the smallest sum of the longest diameters recorded since the treatment began.|Response assessment completed every 8 weeks until disease progression for up to 106 weeks; data cut off 30 June 2012|Intent to treat population = The ITT population consisted of all randomized participants regardless of whether the participant received any study drug or had any efficacy assessments collected.||months||95% Confidence Interval|Median
790069|NCT00864383|Secondary|Sensitivity Analyses Assuming All Losses to Follow-up and Non-tuberculous Deaths Have a Favourable Outcome Using Solid (L-J) Media.|Sensitivity Analysis of Primary Efficacy Results of All Randomized Subjects Imputing Favorable for Missing Outcomes. Analysis is the number of subjects with an unfavorable outcome. Favorable outcome is defined as the number of subjects with a negative TB culture status at 18 months (at or after 72 weeks), who had not already been classified as having an unfavorable outcome, and whose last positive TB culture result (“isolated positive culture”) was followed by at least two negative culture results.|18 months|||participants with unfavorable outcome|||Number
790070|NCT00864383|Secondary|Sensitivity Analysis Assuming All Losses to Follow-up and Non-tuberculous Deaths Have an Unfavorable Outcome Using Solid (L-J) Media.|Sensitivity Analysis of Primary Efficacy Results of All Randomized Subjects Imputing Unfavorable for Missing Outcomes. Analysis is the number of subjects with an unfavorable outcome. Favorable outcome is defined as the number of subjects with a negative TB culture status at 18 months (at or after 72 weeks), who had not already been classified as having an unfavorable outcome, and whose last positive TB culture result (“isolated positive culture”) was followed by at least two negative culture results.|18 months|All randomized subjects.||participants with unfavorable outcome|||Number
790071|NCT00864383|Secondary|Time to First Culture Negative Sputum Sample (MGIT Liquid Media)||18 months|All randomized patients excluding late screen failures||Time to culture negative status / weeks||95% Confidence Interval|Median
790072|NCT00864383|Secondary|Time to First Culture Negative Sputum Sample (LJ Solid Media)|Culture negative for TB using LJ cultures.|18 months|All randomized patients excluding late screen failures||Time to culture negative status / weeks||95% Confidence Interval|Median
790073|NCT00864383|Secondary|Number of Patients Who Are Culture Negative (Liquid MGIT Culture)|Number of patients who are TB MGIT culture negative at 8 weeks.|8 weeks|||participants who are culture negative|||Number
790074|NCT00864383|Secondary|Number of Patients Who Are Culture Negative (Solid LJ Culture)|Number of patients who are TB LJ culture negative at 8 weeks.|8 weeks|Per protocol||participants who are culture negative|||Number
790075|NCT00864383|Secondary|Combined Failure of Bacteriological Cure and Relapse as Defined by Culture Using Liquid Media (Mycobacteria Growth Indicator Tube-MGIT).|The secondary analysis of efficacy outcome was the proportion of patients who had bacteriologically or clinically defined failure or relapse within 18 months after randomization (a composite unfavorable outcome) based on MGIT. Culture-negative status was defined as two negative-culture results at different visits without an intervening positive result. The date of culture-negative status was defined as the date of the first negative-culture result. This status continued until there were two positive cultures, without an intervening negative culture, or until there was a single positive culture that was not followed by two negative cultures. Relapse strains were those shown to be identical on 24-locus Mycobacterial interspersed repetitive units (MIRU) analysis.|18 months (within one year of completion of therapy)|Per protocol population||participants with failure or relapse|||Number
790076|NCT00864383|Primary|Number of Patients With Grade 3 or 4 Adverse Events (Using a Modified Division of Acquired Immunodeficiency Syndrome National Institute of Allergy and Infectious Diseases [DAIDS] Scale of Adverse Event Reporting)|The number of participants includes all patients who had at least one grade 3 or 4 adverse event.|18 months (within one year of completion of therapy)|Safety population, defined as all subjects who underwent randomization and who received at least on dose of study drug.||participants with Grade 3 or 4 AEs|||Number
790094|NCT00870194|Secondary|Change in HDL (mmol/L)|Change in high-density lipoprotein (HDL) cholesterol from baseline to endpoint (Week 20)|Baseline to 20 Weeks|Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.||mmol/L||Standard Error|Least Squares Mean
790077|NCT00864383|Primary|Combined Failure of Bacteriological Cure and Relapse Within One Year of Completion of Therapy as Defined by Culture Using Solid Media (Lowenstein-Jensen - LJ).|The primary efficacy outcome was the proportion of patients who had bacteriologically or clinically defined failure or relapse within 18 months after randomization (a composite unfavorable outcome). Culture-negative status was defined as two negative-culture results at different visits without an intervening positive result. The date of culture-negative status was defined as the date of the first negative-culture result. This status continued until there were two positive cultures, without an intervening negative culture, or until there was a single positive culture that was not followed by two negative cultures. Relapse strains were those shown to be identical on 24-locus Mycobacterial interspersed repetitive units (MIRU) analysis. For the final 18 month study visit when both L-J samples were contaminated or missing, if the subject could not be brought back, liquid medium culture results were used in place of solid medium culture results.|18 months (within one year of completion of therapy)|Per protocol population||participants with failure or relapse|||Number
790078|NCT00864513|Secondary|Number of Participants With Adverse Events|Toxicity by National Cancer Institute Common Toxicity Criteria Adverse Event Version 3.0|30 days after last dose of study drug|||participants|||Number
790079|NCT00864513|Secondary|CA 19-9 Response|CA 19-9 was evaluatd every three weeks, before the next study treatment. Approximately 30% of patients are not expected to have detectable CA 19-9, based on Lews-Y antigen. CA 19-9 response is defined as more than 50% decrease from baseline.|Within two months of the last dose of chemotherapy|Only 10 patients had elevated CA 19-9 at the start of therapy, and were therefore analyzable for this endpoint||participants|||Number
790080|NCT00864513|Secondary|Objective Response|Evaluation of tumor extent by CT scans, according to RECIST criteria (a 20% decrease in the sum of the longest unidimensional measurements of existing disease), version 1.0|Within two months of the completion of the last dose of chemotherapy|||participants|||Number
790081|NCT00864513|Primary|Progression-free Survival|Number of days from first dose of study treatment until the date of progression, as measured by worsening disease (new site of disease, or increase in existing disease) or death.|6 months after last patient enrolled|||days||Full Range|Median
790082|NCT00864539|Primary|Serum Levels of 25hydroxy Vitamin D(25(OH)D)Compared to the Due Control Group|Serum level of 25(OH)D was determined using competitive protein binding assay (CPBA) method.|10 weeks|||nmol/L||Standard Deviation|Mean
790083|NCT00869999|Primary|Overall Response Rate|Complete response plus partial response after 6 cycles. Response rate will be evaluated by using the modified Cheson criteria for lymphoma response. Complete response requires all of the following: 1) PET positive prior to therapy: mass of any size permitted if PET negative. Variable FDG-avid or PET negative prior to therapy: regression to normal size on CT (</= 1.5cm in their greatest transverse diameter for nodes >/= 1.5 cm before therapy) 2) Spleen (if enlarged before therapy) must have regressed in size and must not be palpable, 3) If bone marrow is known to be involved, repeat biopsy documents clearance. Partial response requires 1) >/= 50% decrease in SPD, 2) No new sites of disease or increase in the size of other nodes, liver or spleen, 3) Splenic and hepatic nodules must regress by at least 50% in SPD|Assessed at the conclusion of cycle 2, cycle 4 and cycle 6|||percentage of participants||90% Confidence Interval|Number
790084|NCT00869999|Secondary|Progression-free Survival|Progression-free survival is defined as the duration of time from start of treatment to time of documentation of progression or death|2 years|||months||90% Confidence Interval|Median
790085|NCT00869999|Secondary|Duration of Overall Response|Duration of overall response is measured from the time measurement criteria are met for complete response or partial response until the first date that recurrent or progressive disease is objectively documented.|2 years|||months||90% Confidence Interval|Median
790086|NCT00870103|Primary|The Percentage of Patients With no Ocular Pain||Day 15 after cataract surgery|||Percentage of participants|||Number
790087|NCT00870103|Primary|The Percentage of Patients With a Score of Zero for Anterior Chamber Cells.|"The percentage of patients with a score of zero for Anterior chamber cells.
Anterior chamber inflammation was evaluated based on the number of cells per high-power field measured using the narrowest slit beam of the lamp (0.5 at a height of 8mm).
Anterior chamber cells was recorded on a 0-4 point scale,0 = Less than 5 cells; 1 = Mild: 5-10 cells; 2 = Moderate:11-20 cells; 3 = Marked: 21-50 cells; 4 = Severe: Greater than 50 cells / hypopyon"|Day 15 after cataract surgery|||Percentage of participants|||Number
790088|NCT00870194|Secondary|Incidence of Confirmed Hypoglycemia(Overall)|Incidence of confirmed hypoglycemia experienced overall during the study|Baseline to 20 Weeks|As Treated Patients; Hypoglycemia defined as: patient experiencing a sign or symptom associated with hypoglycemia that is either self-treated or resolves on its own; has a concurrent fingerstick blood glucose <3.0 mmol/L (54 mg/dL).||Participants|||Number
790089|NCT00870194|Secondary|Incidence of Nocturnal Hypoglycemia (Overall)|Incidence of nocturnal hypoglycemia experienced overall during the study|Baseline to 20 Weeks|As Treated Patients||Participants|||Number
790090|NCT00870194|Secondary|Incidence of Severe Hypoglycemia(Overall)|Incidence of severe hypoglycemia experienced overall during the study|Baseline to 20 Weeks|As Treated Patients; Severe hypo:symptoms consistent with hypoglycemia resulting in loss of consciousness or seizure with prompt recovery in response to administration of glucagon or glucose;or documented hypoglycemia (BG< 3.0 mmol/L [54/mg/dL]) requiring the assistance of another person because of severe impairment in consciousness or behavior||Participants|||Number
790091|NCT00870194|Secondary|Incidence of Hypoglycemia (Overall)|Incidence of hypoglycemic episodes experienced overall during the study|Baseline to 20 Weeks|As Treated Patients; Hypoglycemia defined as: patient experiencing a sign or symptom associated with hypoglycemia that is either self-treated or resolves on its own; not confirmed with blood glucose values.||Participants|||Number
790092|NCT00870194|Secondary|Change in Total Cholesterol (mmol/L)|Change in total cholesterol from baseline to endpoint (Week 20)|Baseline to 20 Weeks|Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.||mmol/L||Standard Error|Least Squares Mean
790093|NCT00870194|Secondary|Change in LDL (mmol/L)|Change in low-density lipoprotein (LDL) cholesterol from baseline to endpoint (Week 20)|Baseline to 20 Weeks|Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.||mmol/L||Standard Error|Least Squares Mean
790095|NCT00870194|Secondary|Change in Triglycerides (mmol/L)|Change in triglycerides from baseline to endpoint (Week 20)|Baseline to 20 Weeks|Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.||mmol/L||Standard Error|Least Squares Mean
790096|NCT00870194|Secondary|SMBG (mmol/L)|7 point Self Monitored Blood Glucose Profiles - daily mean value (Week 20)|Baseline to 20 Weeks|Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.||mmol/L||Standard Error|Least Squares Mean
790097|NCT00870194|Secondary|Waist-to-Hip Ratio|Change in waist-to-hip ratio from baseline to endpoint (Week20)|Baseline to 20 Weeks|Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.||Ratio||Standard Error|Least Squares Mean
790098|NCT00870194|Secondary|Change in Waist Circumference (cm)|Change in waist circumference from baseline to endpoint (Week 20)|Baseline to 20 Weeks|Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.||cm||Standard Error|Least Squares Mean
790099|NCT00870194|Secondary|Change in Body Weight (kg)|Change in body weight from baseline to endpoint (Week 20)|Baseline to 20 Weeks|Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.||kg||Standard Error|Least Squares Mean
790100|NCT00870194|Secondary|Change in FSG (mmol/L)|Change in fasting serum glucose (FSG) from baseline to endpoint (Week 20)|Baseline to 20 Weeks|Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.||mmol/L||Standard Error|Least Squares Mean
790101|NCT00870194|Secondary|Percentage of Patients Achieving HbA1c <=6.5%|Percentage of patients whose baseline HbA1c was > 6.5% achieving HbA1c <=6.5% at endpoint (Week 20)|Baseline to 20 Weeks|Patients in the Per Protocol Set whose baseline HbA1c was > 6.5%; Last Observation Carried Forward. Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.||Percentage|||Number
790102|NCT00870194|Secondary|Percentage of Patients Achieving HbA1c <7.0%|Percentage of patients whose baseline HbA1c was >=7.0% achieving HbA1c <7.0% at endpoint (Week 20)|Baseline to 20 Weeks|Patients in the Per Protocol Set whose baseline HbA1c was >= 7.0%; Last Observation Carried Forward. Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.||Percentage|||Number
790103|NCT00870194|Secondary|Percentage of Patients Achieving HbA1c <=7.0%|Percentage of patients whose baseline HbA1c was > 7.0% achieving HbA1c <=7.0% at endpoint (Week 20)|Baseline to 20 Weeks|Patients in the Per Protocol Set whose baseline HbA1c was > 7.0%; Last Observation Carried Forward.Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.||Percentage|||Number
790104|NCT00870194|Primary|Change in HbA1c (Percent)|Change in HbA1c from baseline to endpoint (Week 20); difference of base percent values [X% - Y%]|Baseline to 20 Weeks|Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.||Percent HbA1c||Standard Error|Least Squares Mean
790105|NCT00870467|Secondary|Number of Participants Who Reported Any Adverse Event (Serious or Non-serious) While Receiving Adalimumab Through Week 52|Adverse events were collected at designated study visits for all participants who were randomized and received at least 1 dose of adalimumab. The number of participants who experienced any adverse event (serious or non-serious) while receiving any adalimumab during the study (double-blind adalimumab and/or open-label) is summarized. See the Reported Adverse Event section for details.|Through Week 52|Participants who received at least 1 dose of adalimumab during the study.||participants|||Number
790106|NCT00870467|Secondary|Number of Participants Achieving Clinical Remission, Defined by Disease Activity Score (DAS28[ESR]) <2.6, at Week 52|Disease Activity Score (DAS28) is a combined index used to measure disease activity in patients with rheumatoid arthritis. Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate. DAS28(ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity); decrease is indicative of improvement in disease activity. DAS28(ESR) score <2.6 was defined as clinical remission of disease.|Week 52|Participants who completed the first 26 weeks and received at least 1 dose of adalimumab after Week 26. Analysis performed using observed cases; no imputation technique used.||participants|||Number
790107|NCT00870467|Secondary|Change From Baseline in Disease Activity Score (DAS28[ESR]) at Week 52|Disease Activity Score (DAS28) is a combined index used to measure disease activity in patients with rheumatoid arthritis. Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate. DAS28(ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity); decrease is indicative of improvement in disease activity.|Baseline, Week 52|Participants who completed the first 26 weeks and received at least 1 dose of adalimumab after Week 26. Analysis performed using observed cases; no imputation technique used.||units on a scale||Standard Deviation|Mean
790161|NCT00871000|Primary|Number of Seropositive Subjects for Anti-D and Anti-T Antibodies|A seropositive subject was defined as a subject with anti-D and anti-T concentrations ≥ 0.1 IU/mL. Antibody concentrations have been assessed by enzyme-linked immunosorbent assay (ELISA).|At Month 1, one month post-vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.||Participants|||Count of Participants
790108|NCT00870467|Secondary|Number of Participants Meeting ACR70 Response Criteria at Week 52 (ACR: American College of Rheumatology)|Patients were ACR70 responders if they had: >=70% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus >=70% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire (HAQ); and acute phase reactant C-reactive protein.|Week 52|Participants who completed the first 26 weeks and received at least 1 dose of adalimumab after Week 26. Analysis performed using observed cases; no imputation technique used.||participants|||Number
790109|NCT00870467|Secondary|Number of Participants Meeting ACR50 Response Criteria at Week 52 (ACR: American College of Rheumatology)|Patients were ACR50 responders if they had: >=50% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus >=50% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire (HAQ); and acute phase reactant C-reactive protein.|Week 52|Participants who completed the first 26 weeks and received at least 1 dose of adalimumab after Week 26. Analysis performed using observed cases; no imputation technique used.||participants|||Number
790110|NCT00870467|Secondary|Number of Participants Meeting ACR20 Response Criteria at Week 52 (ACR: American College of Rheumatology)|Patients were ACR20 responders if they had: >=20% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus >=20% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire (HAQ); and acute phase reactant C-reactive protein.|Week 52|Participants who completed the first 26 weeks and received at least 1 dose of adalimumab after Week 26. Analysis performed using observed cases; no imputation technique used.||participants|||Number
790111|NCT00870467|Secondary|Change From Baseline in Modified Total Sharp X-Ray Score at Week 52|Modified Total Sharp Score (mTSS) is a measure of joint health, used in evaluation of inhibition of radiographic progression of disease. Digitized X-rays of hands and feet were obtained then scored in a blinded manner: for erosions (0 [no damage] to 5 [complete collapse or total destruction of joint]) and for joint space narrowing (0 [no damage] to 4 [complete luxation of joint]). Scores were added, giving total mTSS score (0 [normal] to 380 [maximal disease]). Large positive change in mTSS indicates diseae progression; small positive/no change indicates slowing/halting of disease progression.|Baseline, Week 52|Participants who completed 26 weeks and received at least 1 dose of adalimumab after Week 26. Analysis performed using observed cases; no imputation technique used.||units on a scale||Standard Deviation|Mean
790112|NCT00870467|Secondary|Number of Participants Who Reported Any Adverse Event (Serious or Non-serious) on Double-blind Study Drug Through Week 26|Adverse events were collected at designated study visits for all participants who were randomized and received at least 1 dose of study drug. The number of participants who experienced any adverse event (serious or non-serious) while receiving double-blind study drug is summarized. See the Reported Adverse Event section for details.|Through Week 26|All participants who received at least 1 dose of double-blind study drug.||participants|||Number
790113|NCT00870467|Secondary|Number of Participants Achieving Clinical Remission, Defined by Disease Activity Score (DAS28[ESR]) <2.6, at Week 26|Disease Activity Score (DAS28) is a combined index used to measure disease activity in patients with rheumatoid arthritis. Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate. DAS28(ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity); decrease is indicative of improvement in disease activity. DAS28(ESR) score <2.6 was defined as clinical remission of disease.|Week 26|All participants who received at least 1 dose of double-blind study drug and had at least 1 efficacy assessment during double-blind study drug treatment. Non-responder imputation (NRI) performed.||participants|||Number
790114|NCT00870467|Secondary|Change From Baseline in Disease Activity Score (DAS28[ESR]) at Week 26|Disease Activity Score (DAS28) is a combined index used to measure disease activity in patients with rheumatoid arthritis. Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate. DAS28(ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity); decrease is indicative of improvement in disease activity.|Baseline, Week 26|All participants who received at least 1 dose of double-blind study drug and had at least 1 efficacy assessment during double-blind study drug treatment. Last observation carried forward (LOCF) was used for missing data.||units on a scale||Standard Deviation|Mean
790115|NCT00870467|Secondary|Number of Participants Meeting ACR70 Response Criteria at Week 26 (ACR: American College of Rheumatology)|Patients were ACR70 responders if they had: >= 70% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus >=70% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant C-reactive protein. Patients who discontinued or switched to open-label adalimumab prior to Week 26 were considered non-responders.|Week 26|All participants who received at least 1 dose of double-blind study drug and had at least 1 efficacy assessment during double-blind study drug treatment. Non-responder imputation (NRI) performed.||participants|||Number
790116|NCT00870467|Secondary|Number of Participants Meeting ACR50 Response Criteria at Week 26 (ACR: American College of Rheumatology)|Patients were ACR50 responders if they had: >= 50% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus >=50% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant C-reactive protein. Patients who discontinued or switched to open-label adalimumab prior to Week 26 were considered non-responders.|Week 26|All participants who received at least 1 dose of double-blind study drug and had at least 1 efficacy assessment during double-blind study drug treatment. Non-responder imputation (NRI) performed.||participants|||Number
790117|NCT00870467|Secondary|Number of Participants Meeting ACR20 Response Criteria at Week 26 (ACR: American College of Rheumatology)|Patients were ACR20 responders if they had: >= 20% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus >=20% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant C-reactive protein. Patients who discontinued or switched to open-label adalimumab prior to Week 26 were considered non-responders.|Week 26|All participants who received at least 1 dose of double-blind study drug and had at least 1 efficacy assessment during double-blind study drug treatment. Non-responder imputation (NRI) performed.||participants|||Number
790118|NCT00870467|Primary|Change From Baseline in Modified Total Sharp X-Ray Score at Week 26|Modified Total Sharp Score (mTSS) is a measure of joint health, used in evaluation of inhibition of radiographic progression of disease. Digitized X-rays of hands and feet were obtained then scored in a blinded manner: for erosions (0 [no damage] to 5 [complete collapse or total destruction of joint]) and for joint space narrowing (0 [no damage] to 4 [complete luxation of joint]). Scores were added, giving total mTSS (0 [normal] to 380 [maximal disease]). Large positive change in mTSS indicates disease progression; small positive/no change indicates slowing/halting of disease progression.|Baseline, Week 26|All participants who received at least 1 dose of double-blind study drug and had at least 1 efficacy assessment during double-blind study drug treatment. Analysis performed using observed cases; no imputation technique used. Participants who switched to open-label adalimumab before Week 26 were excluded from the analysis.||units on a scale||Standard Deviation|Mean
790119|NCT00870545|Secondary|Family Communication|Family communication measured with the Family Problem Solving Communication scale at baseline, six and 12 months. Scores range from 0-30 with higher scores indicating better communication.|baseline, 6 months, and 12 months|All participants with family communication data at baseline, six and 12 months.||units on a scale||Standard Deviation|Mean
790120|NCT00870545|Secondary|Spouse Social Support|Support measured with the Social Support Index at baseline, six and 12 months. Scores range from 0-68 with higher scores indicating better social support.|baseline, 6 months, and 12 months|All participants with social support data at baseline, six and 12 months.||units on a scale||Standard Deviation|Mean
790121|NCT00870545|Primary|Quality of Marriage|Measure of marriage quality using Quality Marriage Index at baseline, six and 12 months. Scores range from 6-45 with higher scores indicating better quality of marriage.|Baseline, 6 and 12 months|All participants with quality marriage index scores at the three time points||units on a scale||Standard Deviation|Mean
790122|NCT00870545|Primary|Anxiety|Anxiety measured with the Generalized Anxiety Disorder -7 (GAD-7)measured at baseline, six and 12 months. Scores range from 0-21, with lower scores indicating fewer anxiety symptoms.|baseline, 6 months and 12 months|All participants with anxiety scores at 12 months||units on a scale||Standard Deviation|Mean
790123|NCT00870545|Secondary|Family Coping|Family problem solving measured at baseline, six and 12 months with the F-COPES measure. Scores range from 29-145 with higher scores indicating better coping.|Baseline, 6 months and 12 months|All participants with family coping data at baseline, six and 12 months.||units on a scale||Standard Deviation|Mean
790124|NCT00870545|Primary|Spouse Self-report of Depression|Depression measured with the Patient Health Questionnaire (PHQ)-9 at baseline, six and 12 months. Scores range from 0-27 with lower scores indicating less depressive symptoms.|Baseline, 6 months, and 12 months|All participants with depression data at baseline, six and twelve months||units on a scale||Standard Deviation|Mean
790125|NCT00870584|Secondary|Investigator Global Evaluation of Treatment Effectiveness (IGETE) at 24 Weeks|"The IGETE is an assessment of asthma symptom control in response to asthma treatment. It consists of the question What is the investigator's overall impression of the study medication and its effect on the typical symptoms of allergic asthma during the study? The scale is: excellent, good, moderate, poor, and worsening. A good or excellent response is suggested as a means of defining a patient who has responded to treatment."|24 weeks|Full Analysis Set||participants|||Number
790126|NCT00870584|Primary|Change From Baseline in Asthma Control Test (ACT) After 24 Weeks of Treatment|The Asthma Control Test (ACT) is a validated tool to assess overall asthma control over the last 4 weeks in patients aged >= 12 years old. It is a 1 page questionnaire consisting of 5 simple questions assessing: asthma symptoms, use of rescue medications, and the impact of asthma on everyday functioning. All questions are scored on a 5-point Likert scale, with a higher score indicating better control. All scores are added together to calculate a total score. Total score ranges from 5 to 25. A positive change indicates improvement.|Baseline and 24 weeks|"The Full Analysis Set consisted of patients to whom study drug had been assigned through randomization. Patients inappropriately randomized were excluded from this analysis set.
Participants with observations at both baseline and 24 weeks were included in the analysis."||Score on a scale||Standard Deviation|Mean
790127|NCT00870688|Primary|Number of Seizures Within 7 Weeks||7 weeks|||seizures||Standard Deviation|Mean
790128|NCT00870688|Secondary|Data About Efficacy, Safety and Compliance||7 weeks||||||
790129|NCT00870688|Primary|Change in Number of Seizures After Conversion To Valproate Retard Minitablets Once Daily||7 weeks||||||
790130|NCT00870740|Secondary|Rate of Percentage Change From Baseline in Mean Total Brain Volume|Total brain volume was measured by MRI and analyzed by a central reader. Rate of percentage change from baseline calculated using an analysis of covariance adjusting for baseline normalized brain volume. Baseline values = baseline for study 205MS202 (NCT00870740). Missing values post-baseline were imputed using the average value across subjects in the treatment group.|Baseline, Week 52|Per-protocol population (with a baseline and post-baseline assessment): randomized participants who received study treatment, excluding 18 participants from a single site (protocol violation) plus 75 for whom the time between the last dose of study treatment in 205MS201 (NCT00390221) and the first dose in 205MS202 (NCT00870740) was ≥ 56 days.||rate of percentage change||95% Confidence Interval|Number
790131|NCT00870740|Primary|Number of Participants With Development of Anti-DAC Antibodies (ADAb) and Neutralizing Antibodies (NAb) Post-baseline|Number of participants positive and negative for ADAb and NAb, based on all post-baseline immunogenicity assessments during treatment period and follow-up. Participants are stratified differently in this Outcome Measure as per the pre-specified statistical analysis plan.|Up to 72 weeks|All participants in the Safety Population (all randomized participants who received study treatment) with a post-baseline ADAb assessment.||participants|||Number
790132|NCT00870740|Primary|Number of Participants With Abnormalities in Blood Chemistry Laboratory Data|For each abnormality a subject can be counted once. If a subject has more than one occurrence of the same abnormality the highest toxicity grade is counted. ALT=alanine aminotransferase; AST=aspartate aminotransferase; ALP=alkaline phosphatase; GGT=gamma-glutamyl transferase; TSH=thyroid stimulating hormone, ULN=upper limit of normal.|Up to 72 Weeks|Safety Population: all randomized participants who received study treatment; n=number of participants whose baseline value for 205MS202 (NCT00870740) was normal (i.e. not high or low) and who had at least one post-baseline value during the study.||participants|||Number
790133|NCT00870740|Primary|Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities|Hematology parameters evaluated include: white blood cells, lymphocytes, neutrophils, red blood cells (RBC), hemoglobin, and platelets.|Up to 72 Weeks|Number of participants in the safety population (all randomized participants who received study treatment) with at least one post-baseline value.||participants|||Number
790134|NCT00870740|Secondary|Mean Percentage Change From Baseline in Total Volume of Non-gadolinium (Gd)-Enhancing T1 Hypointense Lesions|T1-weighted scans detect areas of hypointensity that represent a greater degree of tissue destruction and axon loss than T2 hyperintense lesions and are more highly correlated with clinical disability measures and neurological deficit. Evaluated by MRI by a central reader. Baseline values = baseline for study 205MS202 (NCT00870740). For post-baseline visits, the total volume of T1 lesions may be imputed using the mean value across all participants within the treatment group. Baseline visits are not imputed.|Baseline, Week 52|Per-protocol population (with a baseline and post-baseline assessment): randomized participants who received study treatment, excluding 18 participants from a single site (protocol violation) plus 75 for whom the time between the last dose of study treatment in 205MS201 (NCT00390221) and the first dose in 205MS202 (NCT00870740) was ≥ 56 days.||percentage change in volume||Standard Deviation|Mean
790135|NCT00870740|Secondary|Mean Percentage Change From Baseline in Total Lesion Volume of T2 Hyperintense Lesions|Lesions detected on T2-weighted sequences represent a range of histopathology related to MS, including edema, inflammation, demyelination, gliosis, and axon loss. Evaluated by MRI by a central reader. Baseline values = baseline for study 205MS202 (NCT00870740). For post-baseline visits, the total volume of T2 lesions may be imputed using the mean value across all subjects within the treatment group. Baseline visits are not imputed.|Baseline, Week 52|Per-protocol population (with a baseline and post-baseline assessment): randomized participants who received study treatment, excluding 18 participants from a single site (protocol violation) plus 75 for whom the time between the last dose of study treatment in 205MS201 (NCT00390221) and the first dose in 205MS202 (NCT00870740) was ≥ 56 days.||percentage change in volume||Standard Deviation|Mean
790136|NCT00870740|Secondary|Mean Volume of New T1 Hypointense Lesions|T1-weighted scans detect areas of hypointensity that represent a greater degree of tissue destruction and axon loss than T2 hyperintense lesions and are more highly correlated with clinical disability measures and neurological deficit. Evaluated by MRI by a central reader. Baseline is volume of new T1 hypointense lesions since baseline in study 205MS201 (NCT00390221). Scans at Week 20 and Week 52 in 205MS202 are relative to baseline in 205MS202 (NCT00870740). For post-baseline visits, the total volume of T1 lesions may be imputed using the mean value across all subjects within the treatment group. Baseline visits are not imputed.|Baseline, Week 20, Week 52|Per-protocol population: randomized participants who received study treatment, excluding 18 participants from a single site (protocol violation) plus 75 for whom the time between the last dose of study treatment in 205MS201 (NCT00390221) and the first dose in 205MS202 (NCT00870740) was ≥ 56 days; n=participants with measurement at given time point.||mm^3||Standard Deviation|Mean
790137|NCT00870740|Secondary|Mean Number of New or Newly-enlarging T2 Hyperintense Lesions|Lesions detected on T2-weighted sequences represent a range of histopathology related to MS, including edema, inflammation, demyelination, gliosis, and axon loss. Evaluated by MRI by a central reader. New or newly enlarging T2 lesions since baseline of study 205MS202 (NCT00870740). For post-baseline visits, the number of T2 lesions may be imputed using the mean value across all participants within the treatment group, if the participant has non-missing baseline data. Baseline visits are not imputed. Participants are stratified differently in this Outcome Measure as per the pre-specified statistical analysis plan.|Baseline, Week 20, Week 52|Per-protocol population: all randomized participants who received study treatment, excluding 18 participants from a single site (protocol violation) plus 75 participants for whom the time between the last dose of study treatment in 205MS201 (NCT00390221) and the first dose in 205MS202 (NCT00870740) was 56 days or longer.||lesions||Standard Deviation|Mean
790138|NCT00870740|Secondary|Mean Number of New Gadolinium-enhancing Lesions|Evaluated by magnetic resonance imaging (MRI) by a central reader. Number of new Gd lesions since the previous scan (the previous scan for Week 20 was Week 52 of study 205MS201 [NCT00390221]). The number of Gd lesions may be imputed using last observation carried forward or using the mean value across all subjects within the treatment group. Baseline visits are not imputed. Participants are stratified differently in this Outcome Measure as per the pre-specified statistical analysis plan.|Week 20, Week 52|Per-protocol population: all randomized participants who received study treatment, excluding 18 participants from a single site (protocol violation) plus 75 participants for whom the time between the last dose of study treatment in 205MS201 (NCT00390221) and the first dose in 205MS202 (NCT00870740) was 56 days or longer.||lesions||Standard Deviation|Mean
790139|NCT00870740|Secondary|Estimated Proportion of Participants With a Relapse|Relapses are defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the INEC. Estimated using Kaplan-Meier analysis where time to first relapse is calculated from date of first dose in the study to date of first confirmed relapse. Participants who received an alternative MS medication before the first relapse were censored at the time of taking the alternative MS medication.|Up to 72 weeks|Per-protocol population: all randomized participants who received study treatment, excluding 18 participants from a single site (protocol violation) plus 75 participants for whom the time between the last dose of study treatment in 205MS201 (NCT00390221) and the first dose in 205MS202 (NCT00870740) was 56 days or longer.||proportion of participants|||Number
790201|NCT00871338|Secondary|Number of Subjects Reporting Any Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.|During the 8-day (Days 0-7)|The analysis was performed on the Primary Total Vaccinated cohort, which included all subjects with at least one study vaccine administration documented during the primary course.||Subjects|||Number
790140|NCT00870740|Secondary|Adjusted Annualized Relapse Rate|Relapses are defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Independent Neurology Evaluation Committee (INEC). Relapse rate is calculated as: (Total number of relapses that occurred during the 205MS202 [NCT00870740] treatment phase divided by the total number of days followed in the treatment phase for 205MS202), multiplied by 365 days. Participants who received an alternative multiple sclerosis (MS) medication during 205MS201 (NCT00390221; Year 1) are not included in the summary of relapses and relapse rate for this study (Year 2). Participants are stratified differently in this Outcome Measure as per the pre-specified statistical analysis plan.|Up to 72 weeks|Per-protocol population: all randomized participants who received study treatment, excluding 18 participants from a single site (protocol violation) plus 75 participants for whom the time between the last dose of study treatment in 205MS201 (NCT00390221) and the first dose in 205MS202 (NCT00870740) was 56 days or longer.||relapses per person-years||95% Confidence Interval|Number
790141|NCT00870740|Primary|Number of Participants With Abnormalities in Vital Signs|For participants who took DAC HYP during 205MS201 (NCT00390221) the baseline is defined as the baseline from 205MS201, and for participants who took placebo during 205MS201 the baseline is defined as the baseline from 205MS202 (NCT00870740). All post-baseline data are taken after first dose in 205MS202 only. SBP=systolic blood pressure; DBP=diastolic blood pressure; bpm=beats per minute; ↑ BL=increase from baseline; ↓ BL=decrease from baseline.|Up to Week 72|Safety population: all randomized participants who received study treatment; n=number of subjects who had a baseline assessment and at least one post-baseline assessment for that vital sign.||participants|||Number
790142|NCT00870740|Primary|Number of Participants With Treatment-emergent Adverse Events (AEs)|Treatment-emergent AE: any untoward medical occurrence after the first dose of study treatment that did not necessarily have a causal relationship with this treatment. Serious AE (SAE): any untoward medical occurrence that at any dose: resulted in death; in the view of the Investigator, placed the subject at immediate risk of death (a life-threatening event); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect. An SAE could also have been a medically significant event that, in the opinion of the Investigator, jeopardized the subject or required intervention to prevent one of the other outcomes listed in the definition above.|Up to 72 weeks|Safety population: all randomized participants who received study treatment. Participants who discontinued study treatment due to an AE and/or withdrew from the study due to an AE that started prior to 205MS202 (NCT00870740) and that was treatment-emergent under 205MS201 (NCT00390221) are included in this summary.||participants|||Number
790143|NCT00870896|Secondary|Change in FEV1/FVC Ratio|We measured the change in FEV1/FVC ratio at baseline and following 30 days of treatment with Spiriva.Change in ratio reflects the percentage value (ratio) at 30 days minus the percentage value (ratio) at baseline x 100|30 days|||percentage change||Standard Deviation|Mean
790144|NCT00870896|Secondary|Change in FEV1 (in Liters)|Change in FEV1 ( in liters) at baseline and following 30 days of treatment with Spiriva|30 days|Power two-sided t-test for C5. our previous studies coefficient of variation for C5 was 3.2%. We propose power 0.80/significance 0.05. multiple comparisons utilize Bonferroni procedure significance will be 0.017 ability to detect minimum difference of 3.7 uMol. Thus, if alpha 0.05 and beta 0.20, to detect difference require 20 subjects each group.||liters||Standard Deviation|Mean
790145|NCT00870896|Primary|Number of Coughs Following Capsaicin Inhalation Challenge at Baseline and Following 30 Days of Treatment With Spiriva (Baseline and 30 Days)|We measured the change in the number of coughs following capsaicin inhalation challenge from baseline followed by 30 days of treatment with spiriva|30 days|Power two-sided t-test for C5. our previous studies coefficient of variation for C5 was 3.2%. We propose power 0.80/significance 0.05. multiple comparisons utilize Bonferroni procedure significance will be 0.017 ability to detect minimum difference of 3.7 uMol. Thus, if alpha 0.05 and beta 0.20, to detect difference require 20 subjects each group.||coughs per dose of capsaicin||Standard Deviation|Mean
790146|NCT00871000|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the whole study period (from Month 0 to Month 1)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.||Participants|||Count of Participants
790147|NCT00871000|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Days 0-30) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.||Subjects|||Number
790148|NCT00871000|Secondary|Number of Subjects With Any Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal, headache and temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade.|At Month 1, one month post-vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.||Participants|||Count of Participants
790149|NCT00871000|Secondary|Number of Subjects With Any Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.||Participants|||Count of Participants
790150|NCT00871000|Secondary|Number of Seroconverted Subjects for Anti-measles, Anti-mumps, Anti-rubella and Anti-varicella|Seroconversion for anti-measles, anti-mumps, anti-rubella and anti-varicella was defined as the appearance of antibodies after vaccination in subjects who were seronegative before vaccination. There were no seronegative subjects for anti-rubella antibodies, prior to vaccination.|At Month 1, one month post-vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.||Participants|||Count of Participants
790151|NCT00871000|Secondary|Number of Subjects With Booster Responses to Anti-PT, Anti-FHA and Anti-PRN|Booster response to the PT, FHA and PRN antigens was defined as: For initially seronegative subjects (pre-vaccination concentration < cut-off of 5 EL.U/mL), antibody concentrations at least four times the cut-off (post-vaccination concentration ≥ 20 EL.U/mL). For initially seropositive subjects with pre-vaccination concentration ≥ 5 EL.U/mL and < 20 EL.U/mL, an increase in antibody concentrations of at least four times the pre-vaccination concentration. For initially seropositive subjects with pre-vaccination concentration ≥ 20 EL.U/mL, an increase in antibody concentrations of at least two times the pre-vaccination concentration.|At Month 1, one month post-vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.||Participants|||Count of Participants
790152|NCT00871000|Secondary|Number of Subjects With Booster Responses to Anti-polio Type 1, 2 and 3|Booster response to the poliovirus antigens was defined as: For initially seronegative subjects (pre-vaccination antibody titre < cut-off of 8), antibody titre ≥ 32. For initially seropositive subjects (pre-vaccination antibody titres ≥ 8), an increase in antibody titres of at least four times the pre-vaccination titre.|At Month 1, one month post-vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.||Participants|||Count of Participants
790153|NCT00871000|Secondary|Number of Subjects With Booster Responses to Anti-D and Anti-T|Booster responses to anti-D and anti-T were defined as: For initially seronegative subjects (pre-vaccination concentration < cut-off of 0.1 IU/mL), antibody concentrations at least four times the assay cut-off (post-vaccination concentration ≥ 0.4 IU/mL). For initially seropositive subjects (pre-vaccination concentration ≥ 0.1 IU/mL), an increase in antibody concentrations of at least four times the pre-vaccination concentration.|At Month 1, one month post-vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.||Participants|||Count of Participants
790154|NCT00871000|Secondary|Anti-rubella Antibody Concentrations|Antibody concentrations were assessed by ELISA, presented as geometric mean concentrations (GMCs) and expressed in IU/mL.|At Month 1, one month post-vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.||IU/mL||95% Confidence Interval|Geometric Mean
790155|NCT00871000|Secondary|Anti-mumps Antibody Concentrations|Antibody concentrations were assessed by ELISA, presented as geometric mean concentrations (GMCs) and expressed in U/mL.|At Month 1, one month post-vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.||U/mL||95% Confidence Interval|Geometric Mean
790156|NCT00871000|Secondary|Anti-measles and Anti-varicella Antibody Concentrations|Antibody concentrations were assessed by ELISA, presented as geometric mean concentrations (GMCs) and expressed in mIU/mL.|At Month 1, one month post-vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.||mIU/mL||95% Confidence Interval|Geometric Mean
790157|NCT00871000|Secondary|Number of Seropositive Subjects for Anti-measles, Anti-mumps, Anti-rubella and Anti-varicella|Seropositivity was defined as: subjects with antibody concentrations ≥ 150 milli-international units per milliliter (mIU/mL), ≥ 231 units per milliliter (U/mL), ≥ 4 international units per milliliter (IU/mL) and ≥ 50 mIU/mL for anti-measles, anti-mumps, anti-rubella and anti-varicella antibodies, respectively.|At Month 1, one month post-vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.||Participants|||Count of Participants
790158|NCT00871000|Secondary|Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies|A seropositive subject was defined as a subject with anti-PT, anti-FHA and anti-PRN concentrations ≥ 5.0 IU/mL. Antibody concentrations have been assessed by ELISA.|At Month 1, one month post-vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.||Participants|||Count of Participants
790159|NCT00871000|Secondary|Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations, expressed in ELISA units per milliliter (EL.U/mL). The reference cut-off value was ≥ 5 EL.U/mL.|At Month 1, one month post-vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
790160|NCT00871000|Secondary|Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens|A seroprotected subject was defined as a subject with anti-D and anti-T concentrations ≥ 1.0 IU/mL. Antibody concentrations have been assessed by ELISA.|At Month 1, one month post-vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.||Participants|||Count of Participants
790691|NCT00877929|Secondary|Change From Baseline in Trough Seated Systolic Blood Pressure to Week 1|Trough blood pressure measurements were the measurements observed at the end of the dosing interval just prior to the next dose of medication.|Baseline, week 1|||mmHg||Standard Error|Least Squares Mean
790162|NCT00871000|Primary|Number of Seroprotected Subjects Against Polio Types 1, 2 and 3|A seroprotected subject was defined as a subject with anti-polio types 1, 2 and 3 titers ≥ the value of 8. Antibody titers have been assessed by neutralization assay.|At Month 1, one month post-vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.||Participants|||Count of Participants
790163|NCT00871000|Primary|Anti-poliovirus Types 1, 2 and 3 Antibody Titres|Antibody titers were presented as geometric mean titers (GMTs) for the assay cut-off ≥ the value of 8.|At Month 1, one month post-vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.||Titers||95% Confidence Interval|Geometric Mean
790164|NCT00871000|Primary|Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL). The reference cut-off value was greater than or equal to (≥) 0.1 IU/mL.|At Month 1, one month post-vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.||IU/mL||95% Confidence Interval|Geometric Mean
790165|NCT00871117|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events are medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the entire study period (from Day 0 to 6 months post-vaccination)|Analysis was performed on the total vaccinated cohort.||subjects|||Number
790166|NCT00871117|Secondary|Number of Subjects With Unsolicited Adverse Events|"An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event."|Up to 31 days (Day 0 through Day 30) after booster vaccination * for Kinrix + M-M-R II -> Varivax Group before vaccination with Varivax|Analysis was performed on the total vaccinated cohort.||subjects|||Number
790167|NCT00871117|Secondary|Number of Subjects With Solicited Local and General Symptoms|Solicited local symptoms included pain, redness and swelling at the injection site. Solicited general symptoms included fever (temperature equal to or greater than 37.5 degrees Celsius), drowsiness and loss of appetite.|Within 4 days (Day 0 to 3) after booster immunization * for Kinrix + M-M-R II -> Varivax Group before vaccination with Varivax|The analysis was performed the total vaccinated cohort on subjects with at least one vaccine administration documented and with available data.||subjects|||Number
790168|NCT00871117|Primary|Geometric Mean Titers (GMTs) for Antibodies to Poliovirus Types 1, 2 and 3|Titers are expressed as GMTs.|One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.|Analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||titer||95% Confidence Interval|Geometric Mean
790169|NCT00871117|Primary|Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (FHA) and Anti-pertactin (Anti-PRN) Booster Responses, Measured in Enzyme-Linked Immunosorbent Assay Units Per Milliliter (EL.U/mL)|"anti-PT, anti-FHA and anti-PRN booster response :
initially sero- (pre-booster antibody concentration below cut-off < 5.0 EL.U/mL) with increase of at least four times cut-off one month after vaccination (concentration post-booster ≥20.0 EL.U/mL)
initially sero+ with pre-booster antibody concentration ≥5.0 EL.U/mL and < 20.0 EL.U/mL with increase of at least four times pre-booster concentration one month post-booster
initially sero+ with pre-booster antibody concentration ≥20.0 EL.U/mL with an increase of at least two times the pre-booster antibody concentration one month post-booster"|One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.|Analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||subjects|||Number
790170|NCT00871117|Secondary|Number of Subjects Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies|Seropositivity was defined as a concentration greater than or equal to 5.0 EL.U/mL|One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.|Analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||subjects|||Number
790171|NCT00871117|Secondary|Number of Subjects Protected Against Poliovirus 1, 2 and 3|"Seroprotection was defined:
* anti-poliovirus type 1, 2 or 3 antibody titer greater than or equal to 8 ED50.
ED50 is defined here as the reverse of the dilution resulting in 50% inhibition."|One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.|Analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||subjects|||Number
790172|NCT00871117|Secondary|Number of Subjects Seroprotected Against Diphteria and Tetanus|"Seroprotection status was defined as:
anti-D antibody concentration greater than or equal to 0.1 IU/mL
anti-T antibody concentration greater than or equal to 0.1 IU/mL"|One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.|Analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||subjects|||Number
790173|NCT00871117|Secondary|Number of Subjects With an Anti-polio 1, 2, 3 Booster Response|"Anti-poliovirus 1, anti-poliovirus 2 and anti-poliovirus 3 booster response:
initially seronegative subjects (pre-booster antibody titer below cut-off of 8 ED50) with an antibody titer ≥ 32 ED50 one month after vaccination
initially seropositive subjects (pre-booster antibody titers ≥ 8 ED50) with an increase at least four times the pre-booster antibody titer one month after vaccination.
ED50 is defined here as the reverse of the dilution resulting in 50% inhibition. The lowest dilution at which serum samples were tested is 1:8 from which a test was considered positive."|One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.|Analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||subjects|||Number
790174|NCT00871117|Secondary|GMCs for Anti-PT, Anti-FHA, Anti-PRN Antibodies|Concentrations are expressed as GMCs in Enzyme-Linked Immunosorbent Assay (ELISA) Units per milliliter (EL.U/mL).|One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.|Analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||EL.U/mL||95% Confidence Interval|Geometric Mean
790175|NCT00871117|Secondary|Geometric Mean Concentrations (GMCs) for Anti-D and Anti-T Antibodies|Concentrations were expressed as GMCs in IU/mL.|One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.|Analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||IU/mL||95% Confidence Interval|Geometric Mean
790176|NCT00871117|Secondary|Number of Subjects With Anti-D and Anti-T Antibody Concentrations Above Cut-off Value|Cut-off value was defined as greater than or equal to 1.0 international units per milliliter (IU/mL).|One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.|Analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||subjects|||Number
790177|NCT00871117|Primary|Number of Subjects With Booster Responses to Diphteria and Tetanus|"Anti-diphteria (anti-D) and anti-tetanus (anti-T) booster response was defined as:
initially seronegative subjects (sero-) (pre-booster antibody concentration below cut-off of < 0.1 international units per milliliter (IU/mL)) with an increase of at least four times the cut-off one month after vaccination (post-booster antibody concentration ≥0.4 IU/mL)
initially seropositive subjects (sero+) (pre-booster antibody concentration ≥0.1 IU/mL) with an increase of at least four times the pre-booster antibody concentration one month after vaccination"|One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.|Analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||subjects|||Number
790178|NCT00871143|Secondary|Body Image Quality of Life Inventory (BIQLI)|The BIQLI is a 19-item self-report scale that measures the impact of body image concerns on a broad range of life domains (e.g. sense of self, social functioning, sexuality, emotional well-being, exercise and grooming); the BIQLI is scored as the average numeric score of all the items from –3 (‘very negative effect’) to +3 (‘very positive effect’); Cronbach’s α for the scale is 0.95.|12 weeks, 1 month post treatment|||units on a scale||Standard Deviation|Mean
790179|NCT00871143|Secondary|Generalised Anxiety Disorder (GAD)-7|The GAD-7 is a 7-item self-report measure for symptoms of generalised anxiety; each item is scored from 0 to 3, and the summed total score ranges from 0 to 21, with higher scores reflecting a greater symptomatology; Cronbach’s α for the measure is 0.92.|12 weeks,1 month post treatment|||units on a scale||Standard Deviation|Mean
790180|NCT00871143|Secondary|Patient Health Questionnaire (PHQ)-9|The PHQ is a 9-item self-report measure of depression; each item is scored from 0 (‘not at all’) to 3 (‘nearly every day’),and the summed total score ranges from 0 to 27, with higher scores reflecting a greater symptomatology of depression; Cronbach’s α for the scale is 0.89.|12 weeks, 1 month post treatment|||units on a scale||Standard Deviation|Mean
790181|NCT00871143|Secondary|Appearance Anxiety Inventory (AAI)|The AAI is a 10- item self-report questionnaire for measuring the frequency of avoidance behaviour and threat-monitoring (e.g. checking, self-focussed attention) that are characteristic of a response to a distorted body image; each item is scored from 0 (‘not at all’) to 4 (‘all the time’), and the range of the total scores is 0–40, with higher scores reflecting a greater frequency of the responses; the AAI has a Cronbach’s α of 0.86.|12 weeks, 1 month post treatment|||units on a scale||Standard Deviation|Mean
790182|NCT00871143|Secondary|Montgomery Asberg Depression Rating Scale (Montgomery and Asberg, 1979).|MADRS is a 10-item clinician scale rated by a blinded assessor to measure symptoms of depression; each item is rated on a 7-point Likert scale from 0 (indicating ‘normal’ or ‘no difficulties’) to 6, and the range is 0–60; higher scores reflect a greater symptomatology; a MADRS total score of ≥ 25 is regarded as moderate, and of >31 as severe.|12 weeks, 1 month post treatment|||units on a scale||Standard Deviation|Mean
790183|NCT00871143|Secondary|Brown Assessment of Beliefs to Measure the Strength of Conviction in Beliefs About Being Ugly (Eisen et al., 1998)|BABS is a 7-item clinician scale rated by a blinded assessor to measure the strength of conviction in a belief (e.g. ‘I am as ugly as the Elephant man’); each item is rated from 0 (‘non-delusional belief, or least pathological’) to 4 (‘delusional belief, or most pathological’) and the total scores range from 0 to 24; higher scores represent an increasing delusionality of beliefs; respondents are classified as having delusional BDD beliefs if their total score is 18 or more, and if they score 4 on the first item, indicating they are completely convinced that their belief is accurate.|12 weeks, 1 month post treatment|||units on a scale||Standard Deviation|Mean
790214|NCT00871338|Secondary|Number of Subjects With Anti-PSC Antibody Concentrations Above the Cut-offs.|The reference cut-offs were ≥ 0.3 µg/mL and ≥ 2 µg/mL.|At Month 10 and Month 11.|The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.||Subjects|||Number
790184|NCT00871143|Primary|Yale Brown Obsessive Compulsive Scale (Modified for BDD) (BDD -YBOCS) (Phillips et al., 1997)|This is a clinician-rated scale administered by a trained blinded assessor. The range is 0–48. Cronbach’s α for the scale is 0.80. Response to treatment is defined as a 30% or greater decrease in the total BDD-YBOCS score, which best corresponded to ‘much improved’ on the Clinical Global Impression (CGI) scale. In the original validation study, this cutoff score produced 1 false negative (96% sensitivity), that is, 1 participant who was rated as much or very much improved on the CGI was not classified as a responder on the BDD-YBOCS using the 30% threshold.|12 weeks, 1 month post treatment|||units on a scale||Standard Deviation|Mean
790185|NCT00871169|Secondary|Toxicity|Toxicity will be evaluated per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Frequency and severity of adverse events will be tabulated using counts of frequently occurring, serious and severe events of interest (i.e. Grade 3 and Grade 4 adverse events, and Serious Adverse Events (SAEs)).|2 years|||participants|||Number
790186|NCT00871169|Primary|Overall Response Rate (ORR)|ORR is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1). Target lesions are assessed by computerized tomography (CT): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. ORR is the percentage of patients who experienced a CR + the percentage of patients who experienced a PR.|2 years|||percentage of participants||95% Confidence Interval|Number
790187|NCT00871234|Secondary|Endothelial Activation Biomarkers||Four weeks||||||
790188|NCT00871234|Secondary|Inflammatory Biomarkers||Four weeks||||||
790189|NCT00871234|Secondary|Blood Pressure||Four weeks||||||
790190|NCT00871234|Secondary|Insulin Sensitivity [(Homeostasis Model Assessment-Insulin Resistance (HOMA-IR)]||Four weeks||||||
790191|NCT00871234|Secondary|Lipid Fractions||Four weeks||||||
790192|NCT00871234|Primary|Flow-mediated Dilation (FMD) of the Brachial Artery|FMD is measured as the percentage increase in brachial artery diameter after increase in blood flow. We measured the change in this percentage from entry (before etravirine was started) and again at four weeks after receiving etravirine.|Entry and four weeks|FMD analysis was per protocol restricted to those who completed the four week trial. The safety analysis was ITT.||Percentage||Inter-Quartile Range|Median
790193|NCT00871286|Primary|Number of Participants Having a CT Done|Total number of participants having a CT scan (sinus) done in each of the two groups over the study interval.|8 weeks|Per protocol; this was a nonpowered convenience sample||participants|||Number
790194|NCT00871286|Primary|Number of Participants in Compliance With Medical Recommendations|Number of participants in each group who complied with medical advice given at the initial appointment.|8 weeks|||participants|||Number
790195|NCT00871338|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization or results in disability/incapacity of a study subjects. Any SAE = any SAE regardless of assessment of relationship to study vaccination.|During the entire study period (Month 0 to Month 11)|The analysis was performed on the Total Vaccinated cohort, which included all subjects for whom data were available.||Subjects|||Number
790196|NCT00871338|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).|An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an AE regardless of intensity grade or relationship to study vaccination.|Within the 31-day (Days 0-30) follow up period after vaccination.|The analysis was performed on the Booster Total Vaccinated cohort, which included all subjects vaccinated with the booster dose.||Subjects|||Number
790197|NCT00871338|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).|An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an AE regardless of intensity grade or relationship to study vaccination.|Within the 31-day (Days 0-30) follow up period after vaccination.|The analysis was performed on the Primary Total Vaccinated cohort, which included all subjects with at least one study vaccine administration documented during the primary course.||Subjects|||Number
790198|NCT00871338|Secondary|Number of Subjects Reporting Any Solicited General Symptoms.|Solicited general symptoms assessed were drowsiness, irritability, loss of appetite and fever [axillary temperature above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any local symptom regardless of intensity grade.|During the 8-day (Days 0-7)|The analysis was performed on the Booster Total Vaccinated cohort, which included all subjects vaccinated with the booster dose.||Subjects|||Number
790199|NCT00871338|Secondary|Number of Subjects Reporting Any Solicited General Symptoms.|Solicited general symptoms assessed were drowsiness, irritability, loss of appetite and fever [axillary temperature above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any local symptom regardless of intensity grade.|During the 8-day (Days 0-7)|The analysis was performed on the Primary Total Vaccinated cohort, which included all subjects with at least one study vaccine administration documented during the primary course.||Subjects|||Number
790200|NCT00871338|Secondary|Number of Subjects Reporting Any Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.|During the 8-day (Days 0-7)|The analysis was performed on the Booster Total Vaccinated cohort, which included all subjects vaccinated with the booster dose.||Subjects|||Number
790242|NCT00871429|Secondary|Percentage of Subjects With Skin Toxicity Grades 0 to 5 Using The NCI Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 at Baseline Visit and 1 Month Follow-up After Using Lindi Products.||one month||||||
790202|NCT00871338|Secondary|Number of Subjects With a Booster Response to Anti-PSC Antibodies.|Booster response defined as: for initially seronegative subjects, antibody concentration ≥ 1.2 µg/mL at post-booster (Month 11); for initially seropositive subjects, antibody concentrations at post-booster ≥ 4 fold the pre-booster.|At Month 11|The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.||Subjects|||Number
790203|NCT00871338|Secondary|Number of Subjects With a Booster Response to Anti-PRP Antibodies.|Booster response defined as: for initially seronegative subjects, antibody concentration ≥ 0.6 µg/mL at post-booster (Month 11); for initially seropositive subjects, antibody concentrations at post-booster ≥ 4 fold the pre-booster.|At Month 11|The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.||Subjects|||Number
790204|NCT00871338|Secondary|Number of Subjects With a Booster Response to rSBA-MenC Antibodies.|Booster response defined as: for initially seronegative subjects, antibody titre ≥ 1:32 at post-booster (Month 11); for initially seropositive subjects, antibody titres at post-booster ≥ 4 fold the pre-booster.|At Month 11|The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.||Subjects|||Number
790205|NCT00871338|Secondary|Titers for Anti-polio 1, 2 and 3.|Titers were expressed as geometric mean titers (GMTs). The seroprotection reference cut-off value was ≥ 1:8.|At Month 10.|The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.||titers||95% Confidence Interval|Geometric Mean
790206|NCT00871338|Secondary|Concentrations for Anti-PT, Anti-FHA and Anti-PRN.|Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity reference cut-off value was ≥ 5 EL.U/mL.|At Month 10.|The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.||EL.U/mL||95% Confidence Interval|Geometric Mean
790207|NCT00871338|Secondary|Concentrations for Anti-T and Anti-D.|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off value was ≥ 0.1 IU/mL. Seropositivity for anti-D was also defined with the ≥ 0.016 IU/mL cut-off (Neutralisation assay).|At Month 10.|The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.||IU/mL||95% Confidence Interval|Geometric Mean
790208|NCT00871338|Secondary|Concentrations for Anti-PSC.|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off value was ≥ 0.3 µg/mL.|At Month 10 and Month 11.|The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.||µg /mL||95% Confidence Interval|Geometric Mean
790209|NCT00871338|Secondary|Titers for rSBA-MenC.|Titers were expressed as geometric mean titers (GMCs). The seropositivity reference cut-off value was ≥ 1:8.|At Month 10 and Month 11.|The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.||titers||95% Confidence Interval|Geometric Mean
790210|NCT00871338|Secondary|Concentrations for Anti-PRP.|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off value was ≥ 0.15 µg/mL.|At Month 10 and Month 11.|The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.||µg /mL||95% Confidence Interval|Geometric Mean
790211|NCT00871338|Secondary|Number of Seroprotected Subjects for Anti-anti-polio Types 1, 2 and 3.|A seroprotected subject was defined as a vaccinated subject who had anti-polio 1, 2 and 3 antibody concentrations ≥ 1:8.|At Month 10.|The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.||Subjects|||Number
790212|NCT00871338|Secondary|Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN.|A seropositive subject was defined as a vaccinated subject who had anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliters (EL.U/mL).|At Month 10.|The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.||Subjects|||Number
790213|NCT00871338|Secondary|Number of Seroprotive Subjects for Anti-D and Anti-T Antibodies.|A seropositive subject was defined as a vaccinated subject who had anti-D (ELISA) and anti-T antibody concentrations ≥ 0.1 IU/mL. Seropositivity for anti-D was also defined with the ≥ 0.016 IU/mL cut-off (Neutralisation assay).|At Month 10.|The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.||Subjects|||Number
790215|NCT00871338|Secondary|Number of Seropositive Subjects Against rSBA-MenC.|A seropositive subject was defined as a vaccinated subject who had rSBA-MenC ≥ 1:8.|At Month 10 and Month 11.|The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.||Subjects|||Number
790216|NCT00871338|Secondary|Number of Seroprotected Subjects for Anti-PRP.|A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).|At Month 10 and Month 11.|The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.||Subjects|||Number
790217|NCT00871338|Secondary|Concentrations for Anti-PNE Serotypes.|Concentrations were expressed as geometric mean concentreations (GMCs). The seropositivity reference cut-off value was ≥ 0.2 µg/mL.|At Month 3.|The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.||µg/mL||95% Confidence Interval|Geometric Mean
790218|NCT00871338|Secondary|Titers for Anti-polio 1, 2 and 3.|Titers were expressed as geometric mean titers (GMTs). The seropositivity reference cut-off value was ≥ 1:8.|At Month 3.|The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.||titers||95% Confidence Interval|Geometric Mean
790219|NCT00871338|Secondary|Concentrations for Anti-PT, Anti-FHA and Anti-PRN.|Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity reference cut-off value was ≥ 5 EL.U/mL.|At Month 3.|The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.||EL.U/mL||95% Confidence Interval|Geometric Mean
790220|NCT00871338|Secondary|Concentrations for Anti-T and Anti-D.|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off value was ≥ 0.1 IU/mL.|At Month 3.|The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.||IU/mL||95% Confidence Interval|Geometric Mean
790221|NCT00871338|Secondary|Concentrations for Anti-PSC.|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off value was ≥ 0.3 µg/mL.|At Month 2 and Month 3.|The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.||µg/mL||95% Confidence Interval|Geometric Mean
790222|NCT00871338|Secondary|Titers for rSBA-MenC.|Titers were expressed as geometric mean titers (GMCs). The seropositivity reference cut-off value was ≥ 1:8.|At Month 2 and Month 3.|The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.||titers||95% Confidence Interval|Geometric Mean
790223|NCT00871338|Secondary|Concentrations for Anti-PRP.|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off value was ≥ 0.15 µg/mL.|At Month 3.|The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.||µg/mL||95% Confidence Interval|Geometric Mean
790224|NCT00871338|Secondary|Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.|A seropositive subject was defined as a vaccinated subject who had anti- pneumococcal antibody concentrations ≥ 0.2 micrograms per milliliter (µg/mL). The anti-PNE serotypes assessed were 4, 6B, 9V, 14, 18C, 19F and 23F.|At Month 3|The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.||Subjects|||Number
790225|NCT00871338|Secondary|Number of Seroprotected Subjects for Anti-poliovirus (Anti-polio) Types 1, 2 and 3.|A seroprotected subject was defined as a vaccinated subject who had anti-polio 1, 2 and 3 antibody concentrations ≥ 1:8.|At Month 3.|The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.||Subjects|||Number
790226|NCT00871338|Secondary|Number of Seropositive Subjects Against Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN).|A seropositive subject was defined as a vaccinated subject who had anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliters (EL.U/mL).|At Month 3.|The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.||Subjects|||Number
790227|NCT00871338|Secondary|Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.|A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).|At Month 3.|The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.||Subjects|||Number
790228|NCT00871338|Secondary|Number of Subjects With Anti-polysaccharide C (Anti-PSC ) Antibody Concentrations Above the Cut-offs.|The reference cut-offs were ≥ 0.3 µg/mL and ≥ 2 µg/mL.|At Month 2 and Month 3.|The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.||Subjects|||Number
790229|NCT00871338|Secondary|Number of Subjects With Anti-PRP Concentrations Antibody Above the Cut-off.|The reference cut-off was ≥ 1.0 micrograms per milliliter (µg/mL).|At Month 3|The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.||Subjects|||Number
790230|NCT00871338|Primary|Number of Seropositive Subjects Against Neisseria Meningitidis Using Baby Rabbit Complement (rSBA-MenC)|A seropositive subject was defined as a vaccinated subject who had rSBA-MenC ≥ 1:8.|At Month 2 and Month 3.|The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.||Subjects|||Number
790231|NCT00871338|Primary|Number of Seroprotected Subjects for Anti-polyribosylribitol Phosphate (Anti-PRP).|A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).|At Month 3|The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.||Subjects|||Number
790232|NCT00871351|Secondary|Percent Change in Total Lipids and Hs-CRP|Total cholesterol, triglycerides, high-density lipoprotein cholesterol (HDL-C), non-HDL-C, and hs-CRP were measured at the start of the treatment period (at start of administration of atorvastatin 10 mg alone) and at the end of study drug (Week 16 or discontinuation).|End of washout to Week 16 or discontinuation|Randomized participants||Percent change||95% Confidence Interval|Mean
790233|NCT00871351|Secondary|Percent Change in Total Lipids and High Sensitivity C-reactive Protein (Hs-CRP)|Total cholesterol, triglycerides, high-density lipoprotein cholesterol (HDL-C), non-HDL-C, and hs-CRP were measured at 4 weeks after the start of the treatment period (after completion of administration of atorvastatin 10 mg alone) and at Week 16 or at discontinuation.|End of Week 4 to Week 16 or discontinuation|Randomized participants||Percent change||95% Confidence Interval|Mean
790234|NCT00871351|Secondary|Number of Participants Whose LDL-C Levels Reached the Lipid Management Target Values|"LDL-C was measured at the end of administration of the study drug (Week 16 or discontinuation).
Target values:
For participants with history of coronary artery disease: <100 mg/dL;
for participants with at least 3 cardiovascular (CV) risk factors: <120 mg/dL;
for participants with 1-2 CV risk factors: <140 mg/dL;
for participants with no CV risk factors: <160 mg/dL."|Week 16 or discontinuation|Randomized participants||Participants|||Number
790235|NCT00871351|Secondary|Percent Change in LDL-C|LDL-C was measured at the start of the atorvastatin 10 mg treatment period (end of the washout period) and at the end of administration of the study drug (Week 16 or discontinuation).|End of washout period to Week 16 or discontinuation|Randomized participants||Percent change||95% Confidence Interval|Mean
790236|NCT00871351|Primary|Percent Change in Low-Density Lipoprotein - Cholesterol (LDL-C) Values|LDL-C was measured before group study drug administration (Week 4, end of atorvastatin single therapy) and at the end of study drug administration (after 12 weeks of study drug treatment, or at discontinuation).|End of Week 4 to Week 16 or discontinuation|Randomized participants||Percent change||95% Confidence Interval|Mean
790237|NCT00871377|Primary|Seizure Frequency|Seizure frequency (seizures per day or seizures per month)|Study completion (42 weeks)|||Seizures per Day||Standard Error|Mean
790238|NCT00871403|Secondary|Percentage of Participants With a Complete Response or a Partial Response|The percentage of participants with a complete response or a partial response was evaluated.|Randomization until response or progressive disease (up to 85 weeks)|ITT Population||percentage of participants|||Number
790239|NCT00871403|Secondary|Best Overall Response, Assessed as the Number of Participants With the Indicated Tumor Response: Investigator Assessed Only|Tumor response was assessed by the Investigator according to the RECIST, version 1.0. A participant was defined as a responder if he/she sustained a complete response (CR; the disappearance of all target lesions) or partial response (PR; >=30% decrease in the sum of the longest diameter of target lesions) for at least 4 weeks at any time during randomized treatment. Stable disease is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started.|Randomization until response or progressive disease (up to 85 weeks)|ITT Population. A participant without a post-baseline assessment of response was considered to be a non-responder; i.e., all randomized participants are included in the denominator.||participants|||Number
790240|NCT00871403|Secondary|Overall Survival (OS)|OS was determined from the date of randomization to the date of death from any cause. Participants who had not died at the time of the cut-off for the final analysis were censored at the date the participants were last known to be alive. Because enrollment in the study was halted prematurely, the ability to achieve an estimate of OS was compromised. Consequently, OS was not estimated.|Randomization until death (up to 85 weeks)|ITT Population|||||
790241|NCT00871403|Primary|Progression-free Survival (PFS)|PFS is defined as the interval between the date of randomization (date on which the investigator evaluated the participant and first determined he/she had disease progression) and the first occurrence of progressive disease (PD) or death from any cause. Per Response Evaluation Criteria in Solid Tumors (RECIST), version 1, PD is defined as a >=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of >=1 new lesion).|Randomization until progression or death (up to 85 weeks)|Intent-to-Treat (ITT) Population: all participants randomized to receive treatment and who were analyzed based on the assigned randomized treatment and not based on actual treatment received/not received. Participants who had neither progressed nor died were censored at the date of the last adequate tumor assessment at the time of the cut-off.||weeks||95% Confidence Interval|Median
790244|NCT00871494|Secondary|Eradication Rate (Bacteriological Response, Investigator Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option)|"Eradication Rate was calculated from the following formula, the number of participants assessed as eradication , presumed eradication and microbial substitution over total participants excluding ones assessed as indeterminate multiplied by 100.
The inclusion criterion regarding fever was amended from the required criteria to the additional criteria in consultation with the regulatory authority. The subset of participants who were enrolled after the protocol amendment was the primary analysis sets for efficacy."|End of treatment, Day 15, Day 29|"Bacteriologic per protocol set consisted of all participants in the clinical per protocol set in whom bacterial pathogens were identified at baseline. No imputation was used for missing data. n in the Measure Categories was the total participants EXCLUDING ones assessed as indeterminate."||percentageof participants||95% Confidence Interval|Number
790245|NCT00871494|Secondary|Eradication Rate (Bacteriological Response, Data Review Committee Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option)|"Eradication Rate was calculated from the following formula, the number of participants assessed as eradication, presumed eradication and microbial substitution over total participants excluding ones assessed as indeterminate multiplied by 100.
The inclusion criterion regarding fever was amended from the required criteria to the additional criteria in consultation with the regulatory authority. The subset of participants who were enrolled after the protocol amendment was the primary analysis sets for efficacy."|End of treatment, Day 15, Day 29|"Bacteriologic per protocol set consisted of all participants in the clinical per protocol set in whom bacterial pathogens were identified at baseline. No imputation was used for missing data. n in the Measure Categories was the total participants EXCLUDING ones assessed as indeterminate."||percentage of participants||95% Confidence Interval|Number
790246|NCT00871494|Secondary|Response Rate (Clinical Response, Investigator Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option)|"Response rate was calculated from the following formula, the number of participants assessed as effective over total participants excluding ones assessed as indeterminate multiplied by 100.
The inclusion criterion regarding fever was amended from the required criteria to the additional criteria in consultation with the regulatory authority. The subset of participants who were enrolled after the protocol amendment was the primary analysis sets for efficacy."|End of Treatment, Day 15 and Day 29|"Clinical per protocol set consisted of all participants who received at least one dose, had no significant violation of protocol, and underwent prescribed evaluations during the observation period. No imputation was used for missing data. n in the Measure Categories means total participants excluding ones assessed as indeterminate."||percentage of participants||95% Confidence Interval|Number
790247|NCT00871494|Primary|Response Rate (Clinical Response, Data Review Committee Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option)|"Response rate was calculated from the following formula, the number of participants assessed as effective over total participants excluding ones assessed as indeterminate multiplied by 100.
The inclusion criterion regarding fever was amended from the required criteria to the additional criteria in consultation with the regulatory authority. The subset of participants who were enrolled after the protocol amendment was the primary analysis sets for efficacy."|End of Treatment, Day 15 and Day 29|"Clinical per protocol set consisted of all participants who received at least one dose, had no significant violation of protocol, and underwent prescribed evaluations during the observation period. No imputation was used for missing data. n in the Measure Categories means total participants excluding ones assessed as indeterminate."||percentage of participants||95% Confidence Interval|Number
790248|NCT00871624|Secondary|Percent of Study Time Spent With a Riker-SAS Score Between 3 and 4 Inclusive||Completed at baseline and every 4 hours after the start of NPPV therapy for the duration of the study||||||
790249|NCT00871624|Primary|Tolerability of NIV as Assessed by an NIV Tolerance Score|NIV tolerance (NIV intolerance score =1 out of 4) A score of 1 for a comfortable and relaxed patient tolerating NIV; a score of 2 for mild intolerance with some discomfort and occasionally grabbing at the NIV mask; a score of 3 for moderate intolerance and discomfort with the NIV mask most of the time but more frequent grabbing at the mask, sometimes pulling it off; and a score of 4 for severe NIV intolerance with agitation and the inability to leave the NIV mask in place. The outcome measure description of the time frame is reported as the average of the NIV tolerance scores reported at the various time frames (0min, 30min, 60 min, 3hr, 6hr, 12hr, and then every 12hr after the start of NIV therapy up to 72 hours)|Completed at time 0min, 30min, 60min, 3hr, 6hr, 12hr, and then every 12 hours after the start of NPPV therapy up to 72 hours|||percentage of time spent tolerant to NIV||Inter-Quartile Range|Median
790250|NCT00871689|Secondary|Number of Patients With Successful Natural Killer Expansion|Successful in vivo donor NK cell expansion will be defined as an absolute circulating donor-derived NK cell count of >100 cells/μl.|Day 72 Post Transplant|||participants|||Number
790251|NCT00871689|Secondary|Median Overall Survival|Average number of days the patients were alive after receiving UCB transplantation.|Month 6|||Days||Full Range|Median
790252|NCT00871689|Primary|Number of Patients With Grade III-IV Acute Graft-Versus-Host (GVHD) Disease|"Number of patients with Grade III-IV GVHD. Graft-versus-host disease (GVHD) is a complication that can occur after a stem cell or bone marrow transplant in which the newly transplanted material attacks the transplant recipient's body.
Acute GVHD usually happens within the first 3 months after transplant."|Day 100 Post Transplant|||participants|||Number
790253|NCT00871689|Secondary|Number of Patients With Complete Remission of Disease|Disease response will be measured by rate of leukemic clearance (clearance of blasts in blood at timepoint 0) and complete remission (less than 5% blasts and recovery of hematopoiesis).|Day 100|||Participants|||Number
790254|NCT00871689|Secondary|Number of Patients With Transplant-Related Death (TRD)|Number of patients whose death is related to study treatment received. TRD is defined as the number of patients that die without prior relapse.|1 Year Post Transplant|||Participants|||Number
790255|NCT00871689|Secondary|Number of Patients With Acute Graft-Versus-Host (GVHD) Disease|"Number of patients with any grade of GVHD. Graft-versus-host disease (GVHD) is a complication that can occur after a stem cell or bone marrow transplant in which the newly transplanted material attacks the transplant recipient's body.
Acute GVHD usually happens within the first 3 months after transplant."|Day 100 Post Transplant|||participants|||Number
790258|NCT00871715|Other Pre-specified|Exit Interview|A multiple question survey interview, administered by a non-treating, unblinded member of the recruiting team. The participant was asked a set of questions regarding activity since the end of the intervention phase. Participants were also asked to report the perceived value of the intervention and study participation. Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.|Post-intervention to 1 year post-randomization||08/2017||||
790259|NCT00871715|Other Pre-specified|Post-Intervention Interview|A multiple question survey interview, administered by a non-treating, unblinded member of the recruiting team. The participant was asked a set of questions to assess the extent to which critical components of the investigational intervention (e.g. impairment mitigation, session intensity, participant chosen tasks, therapist-participant collaboration) were incorporated into each assigned therapy group. Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.|16-20 weeks post-randomization||08/2017||||
790260|NCT00871715|Other Pre-specified|Monthly Telephone Interviews|A monthly telephone interview with the participant to ascertain information about health status, healthcare utilization, medications, other therapies, and adverse events. Some of these data are reported in the adverse event section. Other data (e.g. those related to healthcare utilization) are part of the secondary analyses presently underway. Until published, these are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.|monthly, beginning 30 days post-randomization||08/2017||||
790261|NCT00871715|Secondary|Wolf Motor Function Test (WMFT) Functional Ability Scale (FAS)|Assesses movement quality via digital media review of task performance post hoc, rated on a 6-point ordinal scale. Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.|Baseline to 1 year post-randomization||08/2017||||
790262|NCT00871715|Secondary|Color Trails Making Tests 1 & 2|Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.|Baseline to 1 year post-randomization||08/2017||||
790263|NCT00871715|Secondary|Digits Span Backward|Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.|Baseline to 1 year post-randomization||08/2017||||
790264|NCT00871715|Secondary|Hopkins Verbal Learning Test, Revised (HVLT-R)|Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.|Baseline to 1 year post-randomization||08/2017||||
790265|NCT00871715|Secondary|D-KEFS Verbal Fluency Test|Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.|Baseline to 1 year post-randomization||08/2017||||
790266|NCT00871715|Secondary|Short Blessed Memory Test|Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.|Baseline to 1 year post-randomization||08/2017||||
790267|NCT00871715|Secondary|Confidence in Arm & Hand Movement (CAHM)|Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.|Baseline to 1 year post-randomization||08/2017||||
790268|NCT00871715|Secondary|EQ5D|Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.|Baseline to 1 year post-randomization||08/2017||||
790269|NCT00871715|Secondary|Single-Item Subjective Quality of Life Measurement (SQOL)|Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.|Baseline to 1 year post-randomization||08/2017||||
790270|NCT00871715|Secondary|Reintegration to Normal Living Index (RNLI)|Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.|Baseline to 1 year post-randomization||08/2017||||
790271|NCT00871715|Secondary|Satisfaction With Life Scale (SWLS)|Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.|Baseline to 1 year post-randomization||08/2017||||
790272|NCT00871715|Secondary|Motor Activity Log 28 QOM (MAL-28)|Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.|Baseline to 1 year post-randomization||08/2017||||
790273|NCT00871715|Secondary|As-Tex Sensory Index|Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.|Baseline to 1 year post-randomization||08/2017||||
790274|NCT00871715|Secondary|Patient Health Questionnaire 9 (PHQ-9)|Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.|Baseline to 1 year post-randomization||08/2017||||
790275|NCT00871715|Secondary|Upper Extremity Fugl Meyer (UEFM), Motor Component|Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.|Baseline to 1 year post-randomization||08/2017||||
790276|NCT00871715|Secondary|Wolf Motor Function Test (WMFT) Strength Components|Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.|Baseline to 1 year post-randomization||08/2017||||
790277|NCT00871715|Secondary|Arm Muscle Torque Test|Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.|Baseline to 1 year post-randomization||08/2017||||
790279|NCT00871715|Primary|Stroke Impact Scale (SIS), Hand Function Subscale, Percentage of Participants That Improved at Least 25 Points From Baseline to End-of-study (One Year Post-randomization)|The available range for improvement is from 0-100; thus participants with a baseline SIS score greater than 75 (n=15) were excluded from these analyses.|Baseline to 1 year post-randomization|Number analyzed reflects actual evaluations completed, which varied by outcome assessment. All analyses were also performed in accord with the pre-planned intent-to-treat (ITT) principle with multiple imputation, comparing outcomes by assigned group. No differences were observed between imputed models and actual complete case data.||percentage of participants|||Number
790280|NCT00871715|Primary|Stroke Impact Scale (SIS) Hand Function Subscale Score.|Change from baseline to end-of-study (one year post-randomization). Range: 0-100; positive values reflect an improvement. Higher values indicate better perception of hand function.|Baseline to 1 year post-randomization|Number analyzed reflects actual evaluations completed, which varied by outcome assessment. All analyses were also performed in accord with the pre-planned intent-to-treat (ITT) principle with multiple imputation, comparing outcomes by assigned group. No differences were observed between imputed models and actual complete case data.||units on a scale||95% Confidence Interval|Mean
790281|NCT00871715|Primary|Wolf Motor Function Test Time|Change from baseline to end-of-study (12 months post-randomization) in time required to perform each of the 15 standardized tasks with each upper extremity.|Baseline to 1 year post-randomization|Number analyzed reflects actual evaluations completed, which varied by outcome assessment. All analyses were also performed in accord with the pre-planned intent-to-treat (ITT) principle with multiple imputation, comparing outcomes by assigned group. No differences were observed between imputed models and actual complete case data.||seconds||95% Confidence Interval|Mean
790282|NCT00871715|Primary|Wolf Motor Function Test (WMFT) Log-transformed Time|Change from baseline to end-of-study (12 months post-randomization) in log-transformed time required to perform each of the 15 standardized tasks with each upper extremity.|Baseline to 1 year post-randomization|Number analyzed reflects actual evaluations completed, which varied by outcome assessment. All analyses were also performed in accord with the pre-planned intent-to-treat (ITT) principle with multiple imputation, comparing outcomes by assigned group. No differences were observed between imputed models and actual complete case data.||log(seconds)||95% Confidence Interval|Mean
790283|NCT00871728|Secondary|Percentage of Participants Showing Mycological Cure|Mycological cure was defined as a case in which the results of both potassium hydroxide (KOH) smear test and bacterial identification test (BIT) were found to be negative at each pre-defined time point.|Week 13, 25, 37 and 49|The FAS population, missing values imputed using last observation carried forward (LOCF) method. 'n' included those participants who were evaluable for this measure at specific time points.||percentage of participants|||Number
790284|NCT00871728|Primary|Percentage of Participants Showing 10 Percent or Higher Response in Scoring Clinical Index for Onychomycosis (SCIO) Score at Week 49|The SCIO is based on clinical state and its items include major factors that can have an effect on the outcome of onychomycosis treatment. The factors include the clinical form, depth of an infected area and subungal hyperkeratosis. The SCIO score range from 1 to 30 and higher score indicates more severity. The score is classified into 7 steps and as there is treatment for each step, treatment based on the clinical state can be applied consistently. Percentage of participants who show an improvement in SCIO score by 10 percent or more at Week 49 compared to Baseline were reported.|Baseline and Week 49|The FAS population included all participants except for those participants who violated the major selection and exclusion criteria or did not take the study medication even once or those participants who didn’t participate in Week 5 assessment.||percentage of participants|||Number
790285|NCT00871728|Primary|Percentage of Participants Showing 10 Percent or Higher Response in Scoring Clinical Index for Onychomycosis (SCIO) Score at Week 37|The SCIO is based on clinical state and its items include major factors that can have an effect on the outcome of onychomycosis treatment. The factors include the clinical form, depth of an infected area and subungal hyperkeratosis. The SCIO score range from 1 to 30 and higher score indicates more severity. The score is classified into 7 steps and as there is treatment for each step, treatment based on the clinical state can be applied consistently. Percentage of participants who show an improvement in SCIO score by 10 percent or more at Week 37 compared to Baseline were reported.|Baseline and Week 37|The FAS population included all participants except for those participants who violated the major selection and exclusion criteria or did not take the study medication even once or those participants who didn’t participate in Week 5 assessment.||percentage of participants|||Number
790286|NCT00871728|Primary|Percentage of Participants Showing 10 Percent or Higher Response in Scoring Clinical Index for Onychomycosis (SCIO) Score at Week 25|The SCIO is based on clinical state and its items include major factors that can have an effect on the outcome of onychomycosis treatment. The factors include the clinical form, depth of an infected area and subungal hyperkeratosis. The SCIO score range from 1 to 30 and higher score indicates more severity. The score is classified into 7 steps and as there is treatment for each step, treatment based on the clinical state can be applied consistently. Percentage of participants who show an improvement in SCIO score by 10 percent or more at Week 25 compared to Baseline were reported.|Baseline and Week 25|The FAS population included all participants except for those participants who violated the major selection and exclusion criteria or did not take the study medication even once or those participants who didn’t participate in Week 5 assessment.||percentage of participants|||Number
790287|NCT00871728|Primary|Percentage of Participants Showing 10 Percent or Higher Response in Scoring Clinical Index for Onychomycosis (SCIO) Score at Week 13|The SCIO is based on clinical state and its items include major factors that can have an effect on the outcome of onychomycosis treatment. The factors include the clinical form, depth of an infected area and subungal hyperkeratosis. The SCIO score range from 1 to 30 and higher score indicates more severity. The score is classified into 7 steps and as there is treatment for each step, treatment based on the clinical state can be applied consistently. Percentage of participants who show an improvement in SCIO score by 10 percent or more at Week 13 compared to Baseline were reported.|Baseline and Week 13|The FAS population included all participants except for those participants who violated the major selection and exclusion criteria or did not take the study medication even once or those participants who didn’t participate in Week 5 assessment.||percentage of participants|||Number
790288|NCT00871728|Primary|Percentage of Participants Showing 10 Percent or Higher Response in Scoring Clinical Index for Onychomycosis (SCIO) Score at Week 9|The SCIO is based on clinical state and its items include major factors that can have an effect on the outcome of onychomycosis treatment. The factors include the clinical form, depth of an infected area and subungal hyperkeratosis. The SCIO score range from 1 to 30 and higher score indicates more severity. The score is classified into 7 steps and as there is treatment for each step, treatment based on the clinical state can be applied consistently. Percentage of participants who show an improvement in SCIO score by 10 percent or more at Week 9 compared to Baseline were reported.|Baseline and Week 9|The FAS population included all participants except for those participants who violated the major selection and exclusion criteria or did not take the study medication even once or those participants who didn’t participate in Week 5 assessment.||percentage of participants|||Number
790289|NCT00871728|Primary|Percentage of Participants Showing 10 Percent or Higher Response in Scoring Clinical Index for Onychomycosis (SCIO) Score at Week 5|The SCIO is based on clinical state and its items include major factors that can have an effect on the outcome of onychomycosis treatment. The factors include the clinical form, depth of an infected area and subungal hyperkeratosis. The SCIO score range from 1 to 30 and higher score indicates more severity. The score is classified into 7 steps and as there is treatment for each step, treatment based on the clinical state can be applied consistently. Percentage of participants who show an improvement in SCIO score by 10 percent or more at Week 5 compared to Baseline were reported.|Baseline and Week 5|The Full analysis set (FAS) population included all participants except for those participants who violated the major selection and exclusion criteria or did not take the study medication even once or those participants who didn’t participate in Week 5 assessment.||percentage of participants|||Number
790290|NCT00871741|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Month 0 to Month 9)|The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.||Participants|||Count of Participants
790291|NCT00871741|Secondary|Number of Subjects With Unsolicited Adverse Events AE(s)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Days 0-30) post-vaccination period|The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.||Participants|||Count of Participants
790292|NCT00871741|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|"The solicited general symptoms assessed were drowsiness, irritability, loss of appetite and temperature.
Any = any general symptom irrespective of intensity grade and relationship to vaccination.
Grade 3 Irritability = crying that could not be comforted/prevented normal activity.
Grade 3 Drowsiness = drowsiness that prevented normal activity. Grade 3 Loss of Appetite = did not eat at all. Related = symptoms assessed by the investigator as causally related to vaccination.
Subjects from Control Group did not receive the second study vaccination dose due to study termination."|During the 8-day (Days 0-7) post-vaccination period following each dose and across doses|The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.||Participants|||Count of Participants
790293|NCT00871741|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms|"The solicited local symptoms assessed were pain, redness and swelling. Any = any solicited local symptom irrespective of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.
Subjects from Control Group did not receive the second study vaccination dose due to study termination."|During the 8-day (Days 0-7) post-vaccination period following each dose and across doses|The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.||Participants|||Count of Participants
790294|NCT00871741|Primary|Anti-PRP Antibody Concentrations ≥ 0.15 mg/mL|As the study was terminated, no blood samples were taken. Hence no immunogenicity analyses were done.|At Month 3||||||
790295|NCT00871780|Secondary|Improvement in Timed 25FT Walk Speed and T100T Speed at Week 24 and 48|To determine how well each of the walking tests, T100T or T25FW, predicts walking limitations, participants were stratified by baseline EDSS scores, and walking tests at Weeks 24 and 48 were analyzed. A 15% or 20% improvement indicates that, when compared with baseline walking speed (meters per second), there is at least 15% or 20% improvement at the corresponding timepoint, e.g. (speed at Week 24 – speed at baseline)/speed at baseline*100% ≥ 15% or 20%. Confirmed (conf) improvement at Week 48 indicates that the participant has at least 15% (or 20%) improvement in walking speed at both Week 24 and Week 48.|Baseline, Week 24, Week 48|Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n= number of participants with evaluable data at time point.||participants|||Number
790296|NCT00871780|Secondary|Correlation Between the EDSS and T100T (Spearman Correlation Coefficient)|Spearman correlation coefficient is a non-parametric measure of the correlation (dependence) between 2 variables, giving a value between +1 and −1 inclusive, where 1 is total positive correlation, 0 is no correlation, and −1 is total negative correlation.|Baseline, Week 24, Week 48|Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=number of participants with data evaluated at given time point.||Correlation coefficient|||Number
790297|NCT00871780|Secondary|Correlation Between the EDSS and T100T (Pearson Correlation Coefficient)|Pearson correlation coefficient is a measure of the linear correlation (dependence) between 2 variables, giving a value between +1 and −1 inclusive, where 1 is total positive correlation, 0 is no correlation, and −1 is total negative correlation.|Baseline, Week 24, Week 48|Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=number of participants with data evaluated at given time point.||Correlation coefficient|||Number
790298|NCT00871780|Secondary|Correlation Between the EDSS and T25FW (Spearman Correlation Coefficient)|Spearman correlation coefficient is a non-parametric measure of the correlation (dependence) between 2 variables, giving a value between +1 and −1 inclusive, where 1 is total positive correlation, 0 is no correlation, and −1 is total negative correlation.|Baseline, Week 24, Week 48|Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=number of participants with data evaluated at given time point.||Correlation coefficient|||Number
790299|NCT00871780|Secondary|Correlation Between the EDSS and T25FW (Pearson Correlation Coefficient)|Pearson correlation coefficient is a measure of the linear correlation (dependence) between 2 variables, giving a value between +1 and −1 inclusive, where 1 is total positive correlation, 0 is no correlation, and −1 is total negative correlation.|Baseline, Week 24, Week 48|Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=number of participants with data evaluated at given time point.||Correlation coefficient|||Number
790300|NCT00871780|Secondary|Correlation Between the T100T and T25FW (Spearman Correlation Coefficient)|Spearman correlation coefficient is a non-parametric measure of the correlation (dependence) between 2 variables, giving a value between +1 and −1 inclusive, where 1 is total positive correlation, 0 is no correlation, and −1 is total negative correlation.|Baseline, Week 24, Week 48|Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=number of participants with data evaluated at given time point.||Correlation coefficient|||Number
790301|NCT00871780|Secondary|Correlation Between the T100T and T25FW (Pearson Correlation Coefficient)|Pearson correlation coefficient is a measure of the linear correlation (dependence) between 2 variables, giving a value between +1 and −1 inclusive, where 1 is total positive correlation, 0 is no correlation, and −1 is total negative correlation.|Baseline, Week 24, Week 48|Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=number of participants with data evaluated at given time point.||Correlation coefficient|||Number
790302|NCT00871780|Secondary|Correlation Between the EDSS and MWD (Spearman Correlation Coefficient)|Spearman correlation coefficient is a non-parametric measure of the correlation (dependence) between 2 variables, giving a value between +1 and −1 inclusive, where 1 is total positive correlation, 0 is no correlation, and −1 is total negative correlation.|Baseline, Week 24, Week 48|Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=number of participants with data evaluated at given time point.||Correlation coefficient|||Number
790303|NCT00871780|Secondary|Correlation Between the EDSS and MWD (Pearson Correlation Coefficient)|Pearson correlation coefficient is a measure of the linear correlation (dependence) between 2 variables, giving a value between +1 and −1 inclusive, where 1 is total positive correlation, 0 is no correlation, and −1 is total negative correlation.|Baseline, Week 24, Week 48|Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=number of participants with data evaluated at given time point.||Correlation coefficient|||Number
790304|NCT00871780|Primary|Change From Baseline in Expanded Disability Status Scale (EDSS)|EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated.|Baseline, Week 24, Week 48|Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=number of participants with data at given time point.||units on a scale||Inter-Quartile Range|Median
790305|NCT00871780|Primary|Change From Baseline in Maximum Walking Distance (MWD)||Baseline, Week 24, Week 48|Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=those participants with observed data at given time point.||meters||Inter-Quartile Range|Median
790306|NCT00871780|Primary|Change From Baseline in the Timed 25-foot Walk Test (T25FW)|In the T25FW, the participant is instructed to walk as fast as possible for a distance of 25 feet.|Baseline, Week 24, Week 48|Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=number of participants with data at given time point.||seconds||Inter-Quartile Range|Median
790307|NCT00871780|Primary|Change From Baseline in the Timed 100-meter Walk Test (T100T)|In the T100T, the participant is instructed to walk as fast as possible for a distance of 100 meters.|Baseline, Week 24, Week 48|Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=number of participants with data at given time point.||seconds||Inter-Quartile Range|Median
790308|NCT00871819|Primary|Correlation Coefficient Between Dorsal Root Paresthesia (Total Pixels Derived From Digital Drawing) at Maximum-comfortable Stimulation Level and Anode-cathode Separation Distance (mm)||Immediately post-procedure|||Correlation coefficient|||Number
790309|NCT00871871|Secondary|Part I: Change in the Ratio of Whole Body Glucose Disposal to Plasma Insulin at Steady State in Participants With Normal Glucose Tolerant (NGT)|Steady state was defined as 90-120 minutes post-dose. The ratio was the measure of the quantity of glucose disposed per unit of plasma insulin concentration (PIC). Approximate PIC was estimated by the time-weighted average of the insulin concentration measured at 10 minute intervals, time = 90, 100, 110, and 120 minutes. NGT participants (FPG <100 mg/dL & 2 hour PG <140 mg/dL during a 75g OGTT at screening) were neither IGT nor IFG at screening. IGT - defined as a 2 hour PG >= 140 and <= 199 mg/dL during a 75g OGTT at screening. IFG - defined as FPG between 100 and 125 mg/dL at screening.|90 -120 minutes post-dose|Number of participants with NGT.||(mg/kg/minute)/(µIU/mL)||Standard Deviation|Least Squares Mean
790310|NCT00871871|Secondary|Part I: Change in the Ratio of Whole Body Glucose Disposal to Plasma Insulin at Steady State in Participants With Impaired Fasting Glucose (IFG)|Steady state was defined as 90-120 minutes post-dose. The ratio was the quantity of glucose disposed by the body per kg body weight per minute at steady state divided by the approximate steady state plasma insulin concentration. The approximate steady state plasma insulin concentration was estimated by the time-weighted average of the insulin concentration measured at 10 minute intervals in which time = 90, 100, 110, and 120 minutes. IFG was defined as fasting plasma glucose (FPG) between 100 and 125 mg/dL at screening.|90 -120 minutes post-dose|Number of participants with IFG.||(mg/kg/minute)/(µIU/mL)||Standard Deviation|Least Squares Mean
790311|NCT00871871|Primary|Part II: Ratio of Whole Body Glucose Disposal to Plasma Insulin at Steady-state|Steady state was defined as 90-120 minutes post-dose. The ratio was the quantity of glucose disposed by the body per kg body weight per minute at steady state divided by the approximate steady state plasma insulin concentration. The approximate steady state plasma insulin concentration was estimated by the time-weighted average of the insulin concentration measured at 10 minute intervals in which time = 90, 100, 110, and 120 minutes.|90 -120 minutes post-dose|Number of participants who took ISMN/placebo.||(mg/kg/minute)/(µIU/mL)||Standard Deviation|Least Squares Mean
790312|NCT00871871|Primary|Part I: Change in Insulin Secretion at Steady-state Compared to Placebo in Participants Who Had Normal Glucose Tolerance (NGT)|Steady state was defined as 90-120 minutes post-dose. NGT participants (FPG <100 mg/dL & 2 hour plasma glucose (PG) <140 mg/dL during a 75g oral glucose tolerance test (OGTT) at screening) were neither Impaired Glucose Tolerant (IGT) nor Impaired Fasting Glucose (IFG). IGT was defined as a 2 hour plasma glucose >= 140 and <= 199 mg/dL during a 75g oral glucose tolerance test at screening. IFG was defined as FPG between 100 and 125 mg/dL at screening.|90 -120 minutes post-dose|Number of participants with NGT.||ng/minute||Standard Deviation|Least Squares Mean
790313|NCT00871871|Secondary|Part I: Change in the Ratio of Whole Body Glucose Disposal to Plasma Insulin at Steady State in Participants With Impaired Glucose Tolerant (IGT)|Steady state was defined as 90-120 minutes post-dose. The ratio was the quantity of glucose disposed by the body per kg body weight per minute at steady state divided by the approximate steady state plasma insulin concentration. The approximate steady state plasma insulin concentration was estimated by the time-weighted average of the insulin concentration measured at 10 minute intervals in which time = 90, 100, 110, and 120 minutes. IGT was defined as a 2 hour plasma glucose >= 140 and <= 199 mg/dL during a 75g oral glucose tolerance test at screening.|90 -120 minutes post-dose|Number of participants with IGT.||(mg/kg/minute)/(µIU/mL)||Standard Deviation|Least Squares Mean
790314|NCT00871871|Primary|Part I: Change in Insulin Secretion at Steady-state Compared to Placebo in Participants With Impaired Fasting Glucose (IFG)|Steady state was defined as 90-120 minutes post-dose. IFG was defined as fasting plasma glucose (FPG) between 100 and 125 mg/dL at screening.|90 -120 minutes post-dose|Number of participants with IFG.||ng/minute||Standard Deviation|Least Squares Mean
790315|NCT00871871|Primary|Part I: Change in Insulin Secretion at Steady-state Compared to Placebo in Participants With Impaired Glucose Tolerance (IGT)|Steady state was defined as 90-120 minutes post-dose. IGT was defined as a 2 hour plasma glucose >= 140 and <= 199 mg/dL during a 75g oral glucose tolerance test at screening.|90 -120 minutes post-dose|Number of participants with IGT.||ng/minute||Standard Deviation|Least Squares Mean
790316|NCT00871975|Primary|Number of Participants With Urodynamic Detrusor Overactivity Events or Prostatic Obstruction as Detected by Tetra-NIRS Compared to Urodynamics|The Tetra-NIRS device provides a linear pattern similar to the pressures obtained during urodynamics. The NIRS output shows relative change in hemoglobin concentrations (oxygenated and deoxygenated) where the numerical value does not actually indicate the concentration, so there is no unit of measure. The numerical output is used to track change over time, or trendline analysis. A qualified interpreter studied tracings for significant changes (+/-2 Hb units) in the NIRS patterning during detrusor overactivity events. As well, under its' approved intended use, Tetra-NIRS trendline analysis was compared against urodynamics during voiding in males, such that a downward trend during voiding indicates urethral obstruction, and an upward trend indicates an unobstructed urethra.|1 Year|Male and female patients were included, where the urodynamics tracings were compared against the Tetra NIRS tracings.||participants|||Number
790317|NCT00872001|Secondary|Incidence of Cardiovascular Death, Non-fatal Stroke, and Need for Mechanical Support for SLVD (Intent-to-Treat Population)|Incidence of cardiovascular death, non-fatal stroke, and need for mechanical support for SLVD (any component and composite) through post-operative Day 28 during and following CABG and administration of acadesine or placebo. Components defined as follows: Cardiovascular death: Death due to cardiovascular causes, Non-fatal Stroke: occurrence of a stroke that was confirmed and adjudicated by Clinical Endpoints Committee that did not result in death, and Mechanical Support for SLVD: New use of any mechanical support for ≥1 hour for treatment of low cardiac output.|Up to Post-Operative Day 28|The Intent-to-Treat Population included all participants randomly assigned to a treatment group and did not have to receive study drug. Each participant contributed to no more than one efficacy endpoint in any composite, i.e., a participant who experienced multiple components of an endpoint composite was counted only once in that composite.||Percentage of Participants|||Number
790318|NCT00872001|Primary|Incidence of All-cause Death, Non-fatal Stroke, and Need for Mechanical Support for Severe Left Ventricular Dysfunction (SLVD) (Intent-to-Treat Population)|Incidence of all-cause death, non-fatal stroke, or need for mechanical support for SLVD (any component and composite) through post-operative Day 28 during and following CABG and administration of acadesine or placebo. Components defined as follows: All-cause death: Death from any cause, Non-fatal Stoke: occurrence of a stoke that was confirmed and adjudicated by Clinical Endpoints Committee that did not result in death, and Mechanical Support for SLVD: New use of any mechanical support for ≥1 hour for treatment of low cardiac output.|Up to Post-Operative Day 28|The Intent-to-Treat Population included all participants randomly assigned to a treatment group and did not have to receive study drug. Each participant contributed to no more than one efficacy endpoint in any composite, i.e., a participant who experienced multiple components of an endpoint composite was counted only once in that composite.||Percentage of Participants|||Number
790319|NCT00872027|Primary|Recruitment Feasibility, Defined as the Number of Participants Recruited and Administered a Medication Dose Within 48 Hours of Mechanical Ventilation||Measured within 2 days of participant recruitment|||participants|||Number
790320|NCT00872079|Primary|Patient Genomics|During Aim 2, Determined Patient Genotypes: CYP2C9 and VKORC1.|Baseline|||participants|||Number
790321|NCT00872170|Secondary|Change in Arginase Activity From Baseline to Week 12 Among Sildenafil Group|Change in Arginase activity was calculated as Arginase activity at week 12 minus Arginase activity at baseline.|Baseline and Week 12|Of 14 patients in the Sildenafil arm, 4 patients with discrepant Tricuspid Regurgitant Jet Velocity (TRV) measurements between the local site, core lab and NHLBI readings and one patient who withdrew from the study were excluded. Patients in control group were only assessed at baseline. Therefore, 9 Sildenafil and 0 control patients were used.||U/L||Standard Error|Mean
794818|NCT00916643|Primary|Occurence of Death|The Categories listed in the table are the Adverse Events (or similar) that resulted in death.|Participants were followed for one (1) year following discontinuation of treatment.|Inclusion was per protocol.||participants|||Number
790322|NCT00872170|Secondary|Change in Arginase Concentration From Baseline to Week 12 Among Sildenafil Group|Change in Arginase concentration was calculated as Arginase concentration at week 12 minus Arginase concentration at baseline.|Baseline and Week 12|Of 14 patients in the Sildenafil arm, 4 patients with discrepant Tricuspid Regurgitant Jet Velocity (TRV) measurements between the local site, core lab and NHLBI readings and one patient who withdrew from the study were excluded. Patients in control group were only assessed at baseline. Therefore, 9 Sildenafil and 0 control patients were used.||ng/ml||Standard Error|Mean
790323|NCT00872170|Secondary|Change in Cell Free Hemoglobin From Baseline to Week 12 Among Sildenafil Group|Change in Cell Free Hemoglobin was calculated as Cell Free Hemoglobin at week 12 minus Cell Free Hemoglobin at baseline.|Baseline and Week 12|Of 14 patients in the Sildenafil arm, 4 patients with discrepant Tricuspid Regurgitant Jet Velocity (TRV) measurements between the local site, core lab and NHLBI readings and one patient who withdrew from the study were excluded. Patients in control group were only assessed at baseline. Therefore, 9 Sildenafil and 0 control patients were used.||ug/ml||Standard Error|Mean
790324|NCT00872170|Secondary|Change in Lactate Dehydrogenase (LDH) From Baseline to Week 12 Among Sildenafil Group|Change in Lactate dehydrogenase (LDH) was calculated as LDH at week 12 minus LDH at baseline.|Baseline and Week 12|Of 14 patients in the Sildenafil arm, 4 patients with discrepant Tricuspid Regurgitant Jet Velocity (TRV) measurements between the local site, core lab and NHLBI readings and 2 patients who had no LDH at 12 weeks were excluded. Patients in control group were only assessed at baseline. Therefore, 8 Sildenafil and 0 control patients were used.||U/L||Standard Error|Mean
790325|NCT00872170|Secondary|Change in Soluble Platelet Selectin (sP-SELECTIN) From Baseline to Week 12 Among Sildenafil Group|Change in Soluble platelet selectin (sP-SELECTIN) was calculated as sP-SELECTIN at week 12 minus sP-SELECTIN at baseline.|Baseline and Week 12|Of 14 patients in the Sildenafil arm, 4 patients with discrepant Tricuspid Regurgitant Jet Velocity (TRV) measurements between the local site, core lab and NHLBI readings and one patient who withdrew from the study were excluded. Patients in control group were only assessed at baseline. Therefore, 9 Sildenafil and 0 control patients were used.||ng/ml||Standard Error|Mean
790326|NCT00872170|Secondary|Change in Red Blood Cell (RBC) Arginine From Baseline to Week 12 Among Sildenafil Group|Change in Red Blood Cell (RBC) Arginine was calculated as Red Blood Cell (RBC) Arginine at week 12 minus Red Blood Cell (RBC) Arginine at baseline.|Baseline and Week 12|Of 14 patients in the Sildenafil arm, 4 patients with discrepant Tricuspid Regurgitant Jet Velocity (TRV) measurements between the local site, core lab and NHLBI readings and one patient who withdrew from the study were excluded. Patients in control group were only assessed at baseline. Therefore, 9 Sildenafil and 0 control patients were used.||µM||Standard Error|Mean
790327|NCT00872170|Secondary|Change in Plasma Arginine From Baseline to Week 12 Among Sildenafil Group|Change in Plasma Arginine was calculated as Plasma Arginine at week 12 minus Plasma Arginine at baseline.|Baseline and Week 12|Of 14 patients in the Sildenafil arm, 4 patients with discrepant Tricuspid Regurgitant Jet Velocity (TRV) measurements between the local site, core lab and NHLBI readings and one patient who withdrew from the study were excluded. Patients in control group were only assessed at baseline. Therefore, 9 Sildenafil and 0 control patients were used.||µM||Standard Error|Mean
790328|NCT00872170|Secondary|Change in Echo Left Ventricular End Diastolic Volume (LVEDV) From Baseline to Week 12 Among Sildenafil Group|Change in echo left ventricular end diastolic volume (LVEDV) was calculated as LVEDV at week 12 minus LVEDV at baseline.|Baseline and Week 12|Of 14 patients in the Sildenafil arm, 4 patients with discrepant Tricuspid Regurgitant Jet Velocity (TRV) measurements between the local site, core lab and NHLBI readings and one patient who withdrew from the study were excluded. Patients in control group were only assessed at baseline. Therefore, 9 Sildenafil and 0 control patients were used.||ml||Standard Error|Mean
790329|NCT00872170|Secondary|Change in Echo Left Ventricular End Systolic Volume (LVESV) From Baseline to Week 12 Among Sildenafil Group|Change in echo left ventricular end systolic volume (LVESV) was calculated as LVESV at week 12 minus LVESV at baseline.|Baseline and Week 12|Of 14 patients in the Sildenafil arm, 4 patients with discrepant Tricuspid Regurgitant Jet Velocity (TRV) measurements between the local site, core lab and NHLBI readings and one patient who withdrew from the study were excluded. Patients in control group were only assessed at baseline. Therefore, 9 Sildenafil and 0 control patients were used.||ml||Standard Error|Mean
790330|NCT00872170|Secondary|Change in Tricuspid Regurgitant Jet Velocity (TRV) From Baseline to Week 12 Among Sildenafil Group|Change in tricuspid regurgitant jet velocity (TRV) was calculated as TRV at week 12 minus TRV at baseline. The TRV provides an estimate of pulmonary artery pressure.|Baseline and Week 12|Of 14 patients in the Sildenafil arm, 4 patients with discrepant Tricuspid Regurgitant Jet Velocity (TRV) measurements between the local site, core lab and NHLBI readings and one patient who withdrew from the study were excluded. Patients in control group were only assessed at baseline. Therefore, 9 Sildenafil and 0 control patients were used.||m/s||Standard Error|Mean
790331|NCT00872170|Primary|Change in Six-minute Walk Test (6MWT) Distance From Baseline to Week 12 Among Sildenafil Group|Change in six-minute walk test (6MWT) distance was calculated as 6MWT at week 12 minus 6MWT at baseline.|Baseline and Week 12|Of 14 patients in the Sildenafil arm, 4 patients with discrepant Tricuspid Regurgitant Jet Velocity (TRV) measurements between the local site, core lab and NHLBI readings and 2 patients who had no 6MWT at 12 weeks were excluded. Patients in control group were only assessed at baseline. Therefore, 8 Sildenafil and 0 control patients were used.||meters||Standard Error|Mean
790332|NCT00872339|Secondary|Impact of Pain on Functioning and Well-being||Measured at Month 9|||participants|||Number
790333|NCT00872339|Secondary|Pain Occurrence by Age||Measured at Month 9|||participants|||Number
790334|NCT00872339|Secondary|Common Sites of Pain||Measured at Month 9|||participants|||Number
790335|NCT00872339|Primary|Prevalence of Pain||Measured at Month 9|||participants|||Number
790336|NCT00872430|Primary|Intestinal Transit Time|Radiologic technique consisting of the ingestion of radiopaque markers, followed by a simple x-ray of the abdomen on day 3 of each intervention period. Standard formula, regarding markers ingested, time of ingestion and markers still present on the colon (counted by radiologist unaware of the treatment allocation), provided transit time.|day 3 and day 17|||hours||Standard Deviation|Mean
790380|NCT00867451|Primary|Vanderbilt ADHD Rating Scales - Teacher (VADTRS): Inattention|35-item measure to assess behaviors consistent with ADHD. Nine items reflected the Inattention scale. Range of scores for the Attention Problems domain was 0-27. Higher scores are indicative of higher levels of inattention.|Baseline, Week 5|||units on a scale||Standard Deviation|Mean
790337|NCT00872430|Secondary|Number of Patients With no Evacuation After Each Intervention Period|The number of patients who had not evacuated on day 5 of each intervention period was obtained using questions 1 and 9 of the Scale for Assessment of Constipation Symptoms based on: 1) How many times have you had a bowel movement in the last 24 hours?; 9) Classification of bowel habit on a scale of 1 (terrible) to 5 (excellent).|day 5 and day 19|||participants|||Number
790338|NCT00872521|Secondary|Overall Survival (OS) Stratified by Protein Expression (FGFR3)|Percentage of participants who had no event of death 2 years after Day 1 Cycle 1 of bortezomib, doxorubicin and dexamethasone (PAD) stratified by protein expression (FGFR3).|2 years after Day 1 Cycle 1 of PAD|Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD. The OS was not imputed.||Percentage of participants|||Number
790339|NCT00872521|Secondary|Overall Survival (OS) Stratified by Protein Expression (Bcl-2)|Percentage of participants who had no event of death 2 years after Day 1 Cycle 1 of bortezomib, doxorubicin and dexamethasone (PAD) stratified by protein expression (bcl-2).|2 years after Day 1 Cycle 1 of PAD|Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD. The OS was not imputed.||Percentage of participants|||Number
790340|NCT00872521|Secondary|Overall Survival (OS) Stratified by Protein Expression (Cyclin D1)|Percentage of participants who had no event of death 2 years after Day 1 Cycle 1 of bortezomib, doxorubicin and dexamethasone (PAD) stratified by protein expression (Cyclin D1).|2 years after Day 1 Cycle 1 of PAD|Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD. The OS was not imputed.||Percentage of participants|||Number
790341|NCT00872521|Secondary|Overall Survival (OS) Stratified by Protein Expression (p53).|Percentage of participants who had no event of death 2 years after Day 1 Cycle 1 of bortezomib, doxorubicin and dexamethasone (PAD) stratified by protein expression (p53).|2 years after Day 1 Cycle 1 of PAD|Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD. The OS was not imputed.||Percentage of participants|||Number
790342|NCT00872521|Secondary|Overall Response Rate (ORR) Stratified by Protein Expression (FGFR3)|Number of participants who are responders and nonresponders after 4 cycles of bortezomib, doxorubicin and dexamethasone (PAD) induction stratified by protein expression (FGFR3)|84 days|Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD. The ORR was imputed, with those who discontinued treatment or who had efficacy data unavailable being coded as Non-Responders.||Participants|||Number
790343|NCT00872521|Secondary|Overall Response Rate (ORR) Stratified by Protein Expression (Bcl-2)|Number of participants who are responders and nonresponders after 4 cycles of bortezomib, doxorubicin and dexamethasone (PAD) induction stratified by protein expression (bcl-2)|84 days|Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD. The ORR was imputed, with those who discontinued treatment or who had efficacy data unavailable being coded as Non-Responders.||Participants|||Number
790344|NCT00872521|Secondary|Overall Response Rate (ORR) Stratified by Protein Expression (Cyclin D1).|Number of participants who are responders and nonresponders after 4 cycles of bortezomib, doxorubicin and dexamethasone (PAD) induction stratified by protein expression (Cyclin D1).|84 days|Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD. The ORR was imputed, with those who discontinued treatment or who had efficacy data unavailable being coded as Non-Responders.||Participants|||Number
790345|NCT00872521|Secondary|Overall Response Rate (ORR) Stratified by Protein Expression (p53)|Number of participants who are responders and nonresponders after 4 cycles of bortezomib, doxorubicin and dexamethasone (PAD) induction stratified by protein expression (p53).|84 days|Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD. The ORR was imputed, with those who discontinued treatment or who had efficacy data unavailable being coded as Non-Responders.||Participants|||Number
790346|NCT00872521|Secondary|Assessment of Quality of Life (AQoL) Scores|The AQoL is a multi-attribute utility health-related quality of life (HRQoL) instrument. It combines the 4 dimensions of independent living, relationships, senses and mental health into a single utility score. The AQoL instrument scores between 1 (best HRQoL) and -0.04 (worst possible HRQoL).|Up to 2 years|Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD||Scores on a scale||Standard Deviation|Mean
790347|NCT00872521|Secondary|Overall Survival|Percentage of participants who had no event of death 2 years after Day 1 Cycle 1 of bortezomib, doxorubicin and dexamethasone (PAD).|2 years after Day 1 Cycle 1 of PAD|Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD||Percentage of participants|||Number
790348|NCT00872521|Secondary|Event Free Survival (EFS)|Percentage of participants who did not have any of the following events: Death, Disease progression, Relapse, Cardiovascular accidents, Deep vein thrombosis, Pulmonary embolism, Fracture, Acute renal failure, Nervous system disorders 2 years after Day 1 Cycle 1 of bortezomib, doxorubicin and dexamethasone (PAD).|2 years after Day 1 Cycle 1 of PAD|Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD||Percentage of participants|||Number
790349|NCT00872521|Secondary|Disease Response 3-months After Autologous Stem Cell Transplant (ASCT)|Number of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), stable disease (SD) and relapse as per IMWG criteria.|3-months after ASCT|Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD||Participants|||Number
790350|NCT00872521|Secondary|Overall Response Rate (ORR) to Bortezomib, Doxorubicin and Dexamethasone (PAD) Induction 3-months Following Autologous Stem Cell Transplant (ASCT).|Responders are the number of participants who achieved stringent complete response (sCR)/ complete response (CR), very good partial response (VGPR) or partial response (PR) following PAD induction.|3-months following ASCT|Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD||Participants|||Number
790351|NCT00872521|Secondary|Disease Response After 4 Cycles of Bortezomib, Doxorubicin and Dexamethasone (PAD) Induction|Number of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR) and stable disease (SD).|84 days|Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD||Particiipants|||Number
790352|NCT00872521|Primary|Overall Response Rate (ORR): Number of Participants Who Are Responders (Had Stringent Complete Response [sCR], CR, Very Good Partial Response [VGPR] or Partial Response [PR]) After 4 Cycles of Bortezomib, Doxorubicin and Dexamethasone (PAD) Induction|International Myeloma Working Group (IMWG) criteria – CR: negative immunofixation on the serum and urine, no soft tissue plasmacytomas and <5% plasma cells in the bone marrow; sCR: CR+normal free light chain ratio, no clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR: serum and urine M-protein detected by immunofixation but not electrophoresis, >90% in serum M-protein+urine, M-protein level <100 mg/24hour; PR: ≥50% decrease of serum and M-protein, 24 hour urinary M-protein decrease by ≥90% or <200 mg/24hour|84 days|Intent-to-treat (ITT) population- All enrolled participants who proceeded to receive Day 1 of Cycle 1 of PAD induction.||Participants|||Number
790353|NCT00872534|Primary|Incidence of Subjects With Gastroduodenal Erosions and Ulcers.|Incidence of subjects with gastroduodenal composite scores of 3 or 4 (> 5 erosions or 1 or more ulcers 3 mm or greater in length with unequivocal depth).|After 7 days of study medication|||participants|||Number
790354|NCT00872599|Secondary|HDL-cholesterol Measured During High Salt Fenofibrate in Salt-resistant and Salt-sensitive Hypertension|HDL-cholesterol concentration measured on the last day of fenofibrate treatment in salt-resistant and salt-sensitive hypertensive patients|Measured on day 6 of high salt intake and fenofibrate treatment|All subjects who completed the protocol||mg/dL||Standard Deviation|Mean
790355|NCT00872599|Primary|Change in Blood Pressure During High Salt Intake and Fenofibrate Treatment Compared to High Salt Intake and Placebo Treatment|"Difference in blood pressure (mean arterial pressure) measured on the last day of high salt intake and fenofibrate treatment minus blood pressure (mean arterial pressure) measured during high salt intake and placebo treatment in participants classified as being salt-sensitive versus salt-resistant.
Participants were classified as salt-sensitive if the average study day mean arterial pressure (MAP) was at least 5 mmHg higher during the high salt placebo arm than during low salt intake."|pressure measured on day 6 of high salt fenofibrate minus pressure measured on day 6 of high salt placebo|All subjects who completed entire protocol||mm Hg||Standard Deviation|Mean
790356|NCT00872729|Primary|Pharmacodynamic Parameter: Changes of White Blood Cell (WBC) Cystine Level From Baseline|"The pharmacodynamic (PD) parameter measures the changes of WBC cystine level from the baseline.
Cystine is a disulfide amino acid formed through oxidation of two molecules of cysteine; hence, cystine’s concentration is commonly given in half-cystine equivalents to avoid confusion.
The level of cystine in WBC/leukocytes is expressed in units of nmol half-cystine/mg protein (nmol ½ cystine/mg protein). Half-cystine is quantified by a reduction of cystine followed by an assay for cysteine, which is then normalized by the total cellular protein content within the sample using methods of such as Lowry assay, bicinchoninic acid assay, or Bradford."|up to 12 hours post Cystagon® dosing and RP103 dosing|Sample size is based on feasibility rather than statistical considerations. Analysis time differences (0-6 hours) is due to different absorption characteristics of Cysteamine between RP103 and Cystagon. Cystagon is dosed every 6 hours and there is no measurement after 6 hours and up to 12 hours.||nmol 1/2 cystine/mg protein||Standard Deviation|Mean
790357|NCT00872729|Primary|Plasma Pharmacokinetic Parameter: AUC(0-t) of Cysteamine|t = 6 for Cystagon and t = 12 for RP103. Cystagon is dosed every 6 hours and there is no measurement after 6 hours and up to 12 hours.|12 hours post RP103 dosing and 6 hours post 1st Cystagon® dosing|Subjects were enrolled sequentially according to the study design. A mixed-effects linear model was used to assess differences between the RP103 and Cystagon treatment groups. Sample size is based on feasibility rather than statistical considerations.||umol•h/L||Geometric Coefficient of Variation|Geometric Mean
790358|NCT00872729|Primary|Plasma Pharmacokinetic Parameter: Tmax of Cysteamine||12 hours post RP103 dosing and 7 hours post 1st Cystagon® dosing|||hour||Full Range|Median
790359|NCT00872729|Primary|Plasma Pharmacokinetic Parameter: Cmax of Cysteamine||12 hours post RP103 dosing and 7 hours post 1st Cystagon® dosing|||umol/L||Geometric Coefficient of Variation|Geometric Mean
790360|NCT00872833|Secondary|Report of Pain by Length of the Transfusion Cycle|Subjects reported whether or not they had pain (yes/no) during each transfusion cycle (data on up to 3 transfusion cycles were collected for each subject). The percent of subject-cycles with pain was calculated for the quartiles of the transfusion cycle.|measured daily over the 3 transfusion cycles|Unit of analysis was participant-cycle. Data were collected over (at most) three transfusion cycles for each subject. Transfusion cycle lengths varied, and subjects may be represented in more than one arm/group.||percentage of participant-cycles|Participants||Number
790361|NCT00872833|Primary|Report of Pain by Age Group|Subjects reported whether or not they had pain (yes/no) during each transfusion cycle (data on up to 3 transfusion cycles were collected for each subject). The percent of subject-cycles with pain was calculated for the quartiles of the transfusion cycle.|measured daily over the 3 transfusion cycles|||percentage of participant-cycles|Participants||Number
790362|NCT00872898|Secondary|Change in Children's Communication Checklist-2 (CCC-2) - Interests Subscale|"The Children’s Communication Checklist-2 (CCC-2) Interests Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times [more than twice] a day or always), with a total raw score of 0 (mildest) to 21 (most severe).
The Children’s Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties children may have (across 10 different subscales, consisting of 7 items each) that affect communication (items 1-50), as well as strengths that children may demonstrate when communicating with others (items 51-70)."|From Baseline to Week 12|All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.||units on a scale||Standard Error|Least Squares Mean
790381|NCT00867451|Primary|Percent Total Sleep|Data was gathered via actigraphy. Data on percentage of time individual was immobile during sleep was gathered on a nightly basis for one week at baseline and at week five. Data presented is the mean nightly percentage of immobility for that respective week.|Baseline, Week 5|||percentage of immobility||Standard Deviation|Mean
790382|NCT00867451|Primary|Length of Awake Time|Data was gathered via actigraphy. Data was gathered on a nightly basis for one week at baseline and at week five. Data presented is the mean nightly value (in minutes) for that respective week.|Baseline; Week 5|||minutes||Standard Deviation|Mean
790363|NCT00872898|Secondary|Change in Children's Communication Checklist-2 (CCC-2) - Social Relations Subscale|"The Children’s Communication Checklist-2 (CCC-2) Social Relations Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times [more than twice] a day or always), with a total raw score of 0 (mildest) to 21 (most severe).
The Children’s Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties children may have (across 10 different subscales, consisting of 7 items each) that affect communication (items 1-50), as well as strengths that children may demonstrate when communicating with others (items 51-70)."|From Baseline to Week 12|All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.||units on a scale||Standard Error|Least Squares Mean
790364|NCT00872898|Secondary|Change in Children's Communication Checklist-2 (CCC-2) - Nonverbal Communication Subscale|"The Children’s Communication Checklist-2 (CCC-2) Nonverbal Communication Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times [more than twice] a day or always), with a total raw score of 0 (mildest) to 21 (most severe).
The Children’s Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties children may have (across 10 different subscales, consisting of 7 items each) that affect communication (items 1-50), as well as strengths that children may demonstrate when communicating with others (items 51-70)."|From Baseline to Week 12|All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.||units on a scale||Standard Error|Least Squares Mean
790365|NCT00872898|Secondary|Change in Children's Communication Checklist-2 (CCC-2) - Context Subscale|"The Children’s Communication Checklist-2 (CCC-2) Context Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times [more than twice] a day or always), with a total raw score of 0 (mildest) to 21 (most severe).
The Children’s Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties children may have (across 10 different subscales, consisting of 7 items each) that affect communication (items 1-50), as well as strengths that children may demonstrate when communicating with others (items 51-70)."|From Baseline to Week 12|All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.||units on a scale||Standard Error|Least Squares Mean
790366|NCT00872898|Secondary|Change in Children's Communication Checklist-2 (CCC-2) - Scripted Language Subscale|"The Children’s Communication Checklist-2 (CCC-2) Scripted Language Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times [more than twice] a day or always), with a total raw score of 0 (mildest) to 21 (most severe).
The Children’s Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties children may have (across 10 different subscales, consisting of 7 items each) that affect communication (items 1-50), as well as strengths that children may demonstrate when communicating with others (items 51-70)."|From Baseline to Week 12|All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.||units on a scale||Standard Error|Least Squares Mean
790367|NCT00872898|Secondary|Change in Children's Communication Checklist-2 (CCC-2) - Initiation Subscale|"The Children’s Communication Checklist-2 (CCC-2) Initiation Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times [more than twice] a day or always), with a total raw score of 0 (mildest) to 21 (most severe).
The Children’s Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties children may have (across 10 different subscales, consisting of 7 items each) that affect communication (items 1-50), as well as strengths that children may demonstrate when communicating with others (items 51-70)."|From Baseline to Week 12|All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.||units on a scale||Standard Error|Least Squares Mean
790368|NCT00872898|Secondary|Change in Children's Communication Checklist-2 (CCC-2) - Coherence Subscale|"The Children’s Communication Checklist-2 (CCC-2) Coherence Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times [more than twice] a day or always), with a total raw score of 0 (mildest) to 21 (most severe).
The Children’s Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties children may have (across 10 different subscales, consisting of 7 items each) that affect communication (items 1-50), as well as strengths that children may demonstrate when communicating with others (items 51-70)."|From Baseline to Week 12|All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.||units on a scale||Standard Error|Least Squares Mean
790369|NCT00872898|Secondary|Change in Children's Communication Checklist-2 (CCC-2) - Semantics Subscale|"The Children’s Communication Checklist-2 (CCC-2) Semantics Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times [more than twice] a day or always), with a total raw score of 0 (mildest) to 21 (most severe).
The Children’s Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties children may have (across 10 different subscales, consisting of 7 items each) that affect communication (items 1-50), as well as strengths that children may demonstrate when communicating with others (items 51-70)."|From Baseline to Week 12|All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.||units on a scale||Standard Error|Least Squares Mean
790383|NCT00867451|Primary|Sleep Activity (i.e., Average Amount of Time That the Participant Moved During Sleep)|Data was gathered via actigraphy. Data was gathered on a nightly basis for one week at baseline and at week five. Data presented is the mean nightly value (in minutes) of movement during sleep, for that respective week.|Baseline; Week 5|||minutes||Standard Deviation|Mean
790370|NCT00872898|Secondary|Change in Children's Communication Checklist-2 (CCC-2) - Syntax Subscale|"The Children’s Communication Checklist-2 (CCC-2) Syntax Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times [more than twice] a day or always), with a total raw score of 0 (mildest) to 21 (most severe).
The Children’s Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties children may have (across 10 different subscales, consisting of 7 items each) that affect communication (items 1-50), as well as strengths that children may demonstrate when communicating with others (items 51-70)."|From Baseline to Week 12|All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.||units on a scale||Standard Error|Least Squares Mean
790371|NCT00872898|Secondary|Change in Children’s Communication Checklist-2 (CCC-2) - Speech Subscale|"The Children’s Communication Checklist-2 (CCC-2) Speech Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times [more than twice] a day or always), with a total raw score of 0 (mildest) to 21 (most severe).
The Children’s Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties children may have (across 10 different subscales, consisting of 7 items each) that affect communication (items 1-50), as well as strengths that children may demonstrate when communicating with others (items 51-70)."|From Baseline to Week 12|All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.||units on a scale||Standard Error|Least Squares Mean
790372|NCT00872898|Secondary|Core Autism Treatment Scale-Improvement: Communication|"The Core Autism Treatment Scale-Improvement (CATS-I) Communication Subscale is based on rating 5 items from 1 (very much improved) to 7 (very much worse) with a total score ranging from 5 (improved) to 35 (worsened).
The Core Autism Treatment Scale-Improvement (CATS-I) is designed to utilize a comparison between pretreatment ratings of Core Autism Treatment Scale-Severity (CATS-S) and ratings of improvement after start of therapy (CATS-I). Both parts of the CATS contain 14 items testing for social interaction (items 1-9) and communication (items 10-14). Each of these items is rated from 1 (indicating most benign) to 7 (indicating most severe)."|At Week 12|All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.||units on a scale||Standard Error|Least Squares Mean
790373|NCT00872898|Secondary|Core Autism Treatment Scale-Improvement: Social Interaction|"The Core Autism Treatment Scale-Improvement (CATS-I) Social Interaction Subscale is based on rating 9 items from 1 (very much improved) to 7 (very much worse) with a total score ranging from 9 (improved) to 63 (worsened).
The Core Autism Treatment Scale-Improvement (CATS-I) is designed to utilize a comparison between pretreatment ratings of Core Autism Treatment Scale-Severity (CATS-S) and ratings of improvement after start of therapy (CATS-I). Both parts of the CATS contain 14 items testing for social interaction (items 1-9) and communication (items 10-14). Each of these items is rated from 1 (indicating most benign) to 7 (indicating most severe)."|At Week 12|All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.||units on a scale||Standard Error|Least Squares Mean
790374|NCT00872898|Primary|Change in Total Raw Score of Social Responsiveness Scale|"The Social Responsiveness Scale (SRS) is a 65-item informant-rated assessment, ranging from 0 (no impairment) to 195 (severe social impairment).
Each item is associated with 1 of 5 subscales (social awareness, social cognition, social communication, social motivation and autistic mannerisms). Each item is rated on a 4-point scale from 1 (not true) to 4 (almost always true). The scores are then transposed to a scale from 0 to 3 and scores are summed within each of the 5 subscales. A higher score indicates greater severity of social impairment."|From Baseline to Week 12|All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.||units on a scale||Standard Error|Least Squares Mean
790375|NCT00872898|Secondary|Core Autism Treatment Scale-Improvement: Total Score|"The Core Autism Treatment Scale-Improvement (CATS-I) is based on rating 14 items from 1 (very much improved) to 7 (very much worse) with a total score ranging from 14 (improved) to 98 (worsened).
The Core Autism Treatment Scale-Improvement (CATS-I) is designed to utilize a comparison between pretreatment ratings of Core Autism Treatment Scale-Severity (CATS-S) and ratings of improvement after start of therapy (CATS-I). Both parts of the CATS contain 14 items testing for social interaction (items 1-9) and communication (items 10-14). Each of these items is rated from 1 (indicating most benign) to 7 (indicating most severe)."|At Week 12|All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.||units on a scale||Standard Error|Least Squares Mean
790376|NCT00872898|Primary|Extent of Absorption of Memantine (Part One)|Area under the plasma concentration vs. time curve (AUC) for memantine, as measured in units of nanogram x hours per milliliter.|Baseline to 144 hours. Measurements were taken 0 (predose), 4, 8, 24, 30, 48, 96 and 144 hours post-dose|Four patients enrolled in Part One, receiving a single dose of memantine and having evaluable pharmacokinetic parameters (Pharmacokinetic Population)||ng•h/mL||Standard Deviation|Mean
790377|NCT00867451|Primary|Vanderbilt ADHD Rating Scales - Parent (VADPRS): Hyperactivity/Impulsivity|35-item measure to assess behaviors consistent with ADHD. Nine items reflected the Inattention scale. Range of scores for the Hyperactivity/Impulsivity domain was 0-27. Higher scores are indicative of higher levels of hyperactive/impulsive behaviors.|Baseline, Week 35|||units on a scale||Standard Deviation|Mean
790378|NCT00867451|Primary|Vanderbilt ADHD Rating Scales - Teacher (VADTRS): Hyperactivity/Impulsivity|35-item measure to assess behaviors consistent with ADHD. Nine items reflected the Inattention scale. Range of scores for the Hyperactivity/Impulsivity domain was 0-27. Higher scores are indicative of higher levels of hyperactive/impulsive behaviors.|Baseline, Week 5|||units on a scale||Standard Deviation|Mean
790379|NCT00867451|Primary|Vanderbilt ADHD Rating Scales - Parent (VADPRS): Inattention|35-item measure to assess behaviors consistent with ADHD. Nine items reflected the Inattention scale. Range of scores for the Attention Problems domain was 0-27. Higher scores are indicative of higher levels of inattention.|Baseline, Week 5|||units on a scale||Standard Deviation|Mean
790385|NCT00867490|Secondary|Percentage of Patients Who Achieved a Protocol-defined Blood Pressure Response During the Core Phase of the Study|Blood pressure response was defined as msSBP < 140 mmHg or a 20 mmHg decrease in msSBP at the end of Phase 2 compared to Baseline in Phase 2 or a msDBP < 90 mmHg or a 10 mmHg decrease in msDBP at the end of Phase 2 compared to Baseline in Phase 2.|Baseline Phase 3 to end of Phase 3|Safety population: All patients who took at least one dose of aliskiren 300 mg plus HCTZ 25 mg plus amlodipine 5 mg.||Percentage of patients|||Number
790386|NCT00867490|Secondary|Percentage of Patients Who Achieved Normalized Blood Pressure During the Core Phase of the Study|Normalized was defined as a msSBP < 140 mm Hg and/or a msDBP < 90 mm Hg.|Baseline Phase 3 to end of Phase 3|Safety population: All patients who took at least one dose of aliskiren 300 mg plus HCTZ 25 mg plus amlodipine 5 mg.||Percentage of patients|||Number
790387|NCT00867490|Secondary|Change in Sitting Pulse Rate During the Extension Phase of the Study|Pulse rate was measured once for 30 seconds just prior to blood pressure measurements in the sitting position.|Baseline Phase 3 to end of Phase 3|Safety population: All patients who took at least one dose of aliskiren 300 mg plus HCTZ 25 mg plus amlodipine 5 mg.||BPM (beats per minute)||95% Confidence Interval|Mean
790388|NCT00867490|Secondary|Change in Sitting Pulse Pressure During the Extension Phase of the Study|Pulse pressure is systolic pressure (SP) minus diastolic pressure (DP). The arm in which the highest sitting DPs were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, SP and DP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.|Baseline Phase 3 to end of Phase 3|Safety population: All patients who took at least one dose of aliskiren 300 mg plus HCTZ 25 mg plus amlodipine 5 mg.||mmHg||95% Confidence Interval|Mean
790389|NCT00867490|Secondary|Change in Mean Sitting Systolic Blood Pressure (msSBP) During the Extension Phase of the Study|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.|Baseline Phase 3 to end of Phase 3|Safety population: All patients who took at least one dose of aliskiren 300 mg plus HCTZ 25 mg plus amlodipine 5 mg.||mmHg||95% Confidence Interval|Mean
790390|NCT00867490|Primary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) During the Extension Phase of the Study|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.|Baseline Phase 3 to end of Phase 3|Safety population: All patients who took at least one dose of aliskiren 300 mg plus HCTZ 25 mg plus amlodipine 5 mg.||mmHg||95% Confidence Interval|Mean
790391|NCT00867490|Secondary|Percentage of Patients Who Achieved a Protocol-defined Blood Pressure Response During the Core Phase of the Study|Blood pressure response was defined as msSBP < 140 mmHg or a 20 mmHg decrease in msSBP at the end of Phase 2 compared to Baseline in Phase 2 or a msDBP < 90 mmHg or a 10 mmHg decrease in msDBP at the end of Phase 2 compared to Baseline in Phase 2.|Baseline Phase 2 to end of Phase 2|Intent-to-treat population (ITT): All patients who took at least one dose of aliskiren plus HCTZ who had at least one primary efficacy parameter evaluation. Patients who dropped out were included in the ITT population if there was any BP measurement available; their last available blood pressure measurement was used for the analysis.||Percentage of patients|||Number
790392|NCT00867490|Secondary|Percentage of Patients Who Achieved Normalized Blood Pressure During the Core Phase of the Study|Normalized blood pressure was defined as a msSBP < 140 mmHg and/or a msDBP < 90 mmHg.|Baseline Phase 2 to end of Phase 2|Intent-to-treat population (ITT): All patients who took at least one dose of aliskiren plus HCTZ who had at least one primary efficacy parameter evaluation. Patients who dropped out were included in the ITT population if there was any BP measurement available; their last available blood pressure measurement was used for the analysis.||Percentage of patients|||Number
790393|NCT00867490|Secondary|Change in Sitting Pulse Rate During the Core Phase of the Study|Pulse rate was measured once for 30 seconds just prior to blood pressure measurements in the sitting position.|Baseline Phase 2 to end of Phase 2|Intent-to-treat population (ITT): All patients who took at least one dose of aliskiren plus HCTZ who had at least one primary efficacy parameter evaluation. Patients who dropped out were included in the ITT population if there was any BP measurement available; their last available blood pressure measurement was used for the analysis.||BPM (beats per minute)||95% Confidence Interval|Mean
790394|NCT00867490|Secondary|Change in Sitting Pulse Pressure During the Core Phase of the Study|Pulse pressure is systolic pressure (SP) minus diastolic pressure (DP). The arm in which the highest sitting DPs were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, SP and DP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.|Baseline Phase 2 to end of Phase 2|Intent-to-treat population (ITT): All patients who took at least one dose of aliskiren plus HCTZ who had at least one primary efficacy parameter evaluation. Patients who dropped out were included in the ITT population if there was any BP measurement available; their last available blood pressure measurement was used for the analysis.||mmHg||95% Confidence Interval|Mean
790409|NCT00873041|Secondary|Extension Study: Change From Baseline in Transferrin Saturation at Month 24|Blood was collected for transferrin saturation at Baseline and Month 24. Change from baseline= Month 24 transferrin saturation - baseline transferrin saturation.|Core Baseline, Month 24|Full Analysis Set (all randomized patients). Only patients with a value both at baseline and at considered timepoint are included in the analyses.||Percent saturation||95% Confidence Interval|Mean
790395|NCT00867490|Secondary|Change in Mean Sitting Systolic Blood Pressure (msSBP) During the Core Phase of the Study|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.|Baseline Phase 2 to end of Phase 2|Intent-to-treat population (ITT): All patients who took at least one dose of aliskiren plus HCTZ who had at least one primary efficacy parameter evaluation. Patients who dropped out were included in the ITT population if there was any BP measurement available; their last available blood pressure measurement was used for the analysis.||mmHg||95% Confidence Interval|Mean
790396|NCT00867490|Primary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) During the Core Phase of the Study|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.|Baseline Phase 2 to end of Phase 2|Intent-to-treat population (ITT): All patients who took at least one dose of aliskiren plus HCTZ who had at least one primary efficacy parameter evaluation. Patients who dropped out were included in the ITT population if there was any BP measurement available; their last available blood pressure measurement was used for the analysis.||mmHg||95% Confidence Interval|Mean
790397|NCT00867503|Primary|Overall Survival in Patients With Platinum and Taxane Refractory Ovarian Cancer, Fallopian Tube Cancer and Primary Peritoneal Cancer With Bendamustine Treatment.||Life of study|||Days||Full Range|Median
790398|NCT00867503|Secondary|Toxicities of Patients Treated With Bendamustine.|Grade 4 Toxicity|Life of the study|||Partcipants|||Number
790399|NCT00867503|Primary|Progression Free Survival in Patients With Platinum and Taxane Refractory Ovarian Cancer, Fallopian Tube Cancer and Primary Peritoneal Cancer With Bendamustine Treatment.|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria or Cancer Antigen (CA)125 response using the modified Gynecologic Cancer Intergroup(GCIG) criteria|life of the study|||Days||Full Range|Median
790400|NCT00872989|Secondary|Number of Participants With a Complete Response, Partial Response, Stable Disease, or Increasing Disease After Treatment With Single Agent Vandetanib Following Progression on Single Agent Docetaxel|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR in conjunction with measured CA125 responses|Disease assessments were performed every 6 weeks for as long as the patient remained on protocol, up to 5 years.|Analysis of response is in the subset of patients who had at least one measurable target lesion at baseline.||participants|||Number
790401|NCT00872989|Secondary|Time to Treatment Failure|Time to treatment failure after treatment with single agent vandetanib following progression on single agent docetaxel. Disease assessments were performed every 6 weeks for as long as the patient remained on protocol, up to 5 years.|Disease assessments were performed every 6 weeks for as long as the patient remained on protocol, up to 5 years.|||Months||95% Confidence Interval|Median
790402|NCT00872989|Secondary|Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs|Adverse Events (AEs) are reported by CTCAE Version 3.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.|Toxicity assessment was evaluated before each treatment cycle (21 days), up to 5 years.|Eligible patients who had received the protocol treatments were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.||Participants|||Number
790403|NCT00872989|Secondary|Overall Survival|From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|every 3 months for two years and then every 6 months for 3 years|||months||95% Confidence Interval|Median
790404|NCT00872989|Secondary|Number of Participants With a Complete Response, Partial Response, Stable Disease, or Increasing Disease|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR in conjunction with measured CA125 responses|Disease assessment for responses were performed every 6 weeks for as long as the patient remained on protocol treatment, up to 5 years.|Analysis of response is in the subset of patients who had at least one measurable target lesion at baseline.||participants|||Number
790405|NCT00872989|Primary|Progression Free Survival (PFS)|From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact.|Disease assessments were performed every 6 weeks for as long as the patient remained on protocol, up to 5 years|||months||95% Confidence Interval|Median
790406|NCT00873015|Secondary|Efficacy of 14 Day Infusion of Sodium Nitrite||14 days||||||
790407|NCT00873015|Secondary|Safety of a 14 Day Infusion of Sodium Nitrite||14 days||||||
790408|NCT00873015|Primary|Mean Plasma Nitrite Concentration (Micromol/L)|Samples for pharmacokinetic analysis were collected from subjects treated with sodium nitrite at -15, -5, 0, 10, 30, 60, and 90 minutes after starting nitrite infusion and then at 2, 4, 6, 8, 12, 24, and every 24 hours after starting nitrite infusion. The sample at the time of starting the infusion was considered to be the time 0 sample. On study day 14 additional blood samples were collected at 0, 10, 30, 60, and 90 minutes and at 2, 4, 6, 8, and 12 hours after stopping nitrite infusion. Blood samples were analyzed for nitrite levels using mass spectroscopy.|multiple time points up to the end of day 14|Per protocol||micromol/L||Standard Deviation|Mean
790422|NCT00873041|Secondary|Core Study: Change From Baseline in Hemoglobin at Month 12|Blood was collected for Hemoglobin at baseline and Month 12. Change from baseline= Month 12 hemoglobin - baseline hemoglobin.|Baseline, Month 12|Full Analysis Set (all randomized participants). Only patients with a value both at baseline and at considered timepoint are included in analyses.||g/L||Standard Deviation|Mean
790410|NCT00873041|Secondary|Extension Study: Change From Baseline in Hemoglobin at Month 24|Blood was collected for Hemoglobin at Baseline and Month 24. Change from Baseline= Month 24 hemoglobin - Baseline hemoglobin.|Core Baseline, Month 24|Full Analysis Set (all randomized participants). Only patients with a value both at baseline and at considered timepoint are included in analyses.||g/L||95% Confidence Interval|Mean
790411|NCT00873041|Secondary|Extension Study: Correlation Between Serum Ferritin and LIC (Liver Iron Concentration)|"The correlation between serum ferritin and LIC was investigated using a scatter plot with a regression line for serum ferritin difference from Baseline at Month 24 versus LIC difference from Baseline at Month 24.
A value of 1.0 indicates a perfect correlation."|Core Baseline, Month 24|Participants from the Extension Full Analysis Set (all randomized participants)in the Extension Study with data available for analysis.||Correlation coefficient|||Number
790412|NCT00873041|Secondary|Extension Study: Change in Liver Iron Concentration (LIC) From Baseline at Month 24|LIC was measured by magnetic resonance imaging technique at Baseline and Month 24. A negative change from baseline indicated improvement.|Core Baseline, Month 24|Full Analysis Set. The last available post-baseline LIC was carried forward if no LIC value was available at Week 52. Only patients with both baseline and at least one post-baseline value were included for this analysis.||mg iron (Fe)/g dry weight (dw)||Standard Deviation|Mean
790413|NCT00873041|Primary|Extension Study: Percentage of Participants Reaching a Liver Iron Concentration (LIC) < 5 mg Fe/g dw From Core Baseline to End of Extension Study|Liver iron concentration was measured at Core Baseline and at the end of the Extension Study. Magnetic Resonance Imaging (MRI) scans were analyzed at a central laboratory to determine the LIC value. The percentage of participants with LIC < 5 mgFe/g dw (milligram iron/gram dry weight) change from Baseline at the end of the Extension Study is reported.|Core Baseline to End of Extension Study (up to 24 months)|Full Analysis consisted of all randomized participants. Patients with post-baseline LIC satisfying criterion at any time during the study are counted as responder. Patients with no baseline LIC or without any post-baseline LIC measurements will be assumed as non-responder.||Percentage of participants||95% Confidence Interval|Number
790414|NCT00873041|Secondary|Extension Study: Absolute Change in Serum Ferritin From Baseline to Eighth Quarter|Blood was collected for serum ferritin at Core Baseline and monthly during the Eighth quarter of the Extension Study. Absolute change from Baseline: quarterly average – baseline average. A negative change from baseline indicated improvement.|Core Baseline, Eighth Quarter (last 3 months of the study)|Full Analysis Set included all randomized participants. Only patients with a value both at baseline and at considered time point are included.||micrograms/liter||Standard Deviation|Mean
790415|NCT00873041|Secondary|Core Study: Percentage of Participants With Notably Abnormal Post-baseline Pulse Rate|"Pulse Rate was measured at each visit.
A Notably Abnormal Pulse Rate was defined as a measurement in one of the following two categories:
High: ≥120 with an increase from baseline ≥15 beats per minute (bpm)
Low: ≤50 with a decrease from baseline ≥15 bpm"|Baseline, 52 Weeks|Safety Set includes all randomized participants who received treatment.||Percentage of participants|||Number
790416|NCT00873041|Secondary|Core Study: Percentage of Participants With Notably Abnormal Post-baseline Diastolic Blood Pressure|"Diastolic blood pressure was measured at each visit after the patient rested in the sitting position for at least 3 minutes.
A Notably Abnormal Diastolic Blood Pressure was defined as a measurement in one of the following two categories:
High: ≥105 with an increase from baseline ≥15 mmHg
Low: ≤50 with a decrease from baseline ≥15 mmHg"|Baseline, 52 Weeks|Safety Set includes all randomized participants who received treatment.||Percentage of participants|||Number
790417|NCT00873041|Secondary|Core Study: Percentage of Participants With Notably Abnormal Post-baseline Systolic Blood Pressure|"Systolic blood pressure was measured at each visit after the patient rested in the sitting position for at least 3 minutes.
A Notably Abnormal Systolic Blood Pressure was defined as a measurement in one of the following two categories:
High: ≥180 with an increase from baseline ≥20 mmHg
Low: ≤90 with a decrease from baseline ≥20 mmHg"|Baseline, 52 Weeks|Safety Set includes all randomized participants who received treatment.||Percentage of participants|||Number
790418|NCT00873041|Primary|Core Study: Change in Liver Iron Concentration (LIC) From Baseline to Week 52|LIC was measured by magnetic resonance imaging technique at baseline and Week 52. Estimates were obtained from an Analysis of Covariance (ANCOVA) model for change in LIC between baseline and Week 52 with treatment as factor and baseline LIC as covariate.|Baseline, Week 52|Full Analysis Set. The last available post-baseline LIC was carried forward if no LIC value was available at Week 52. Only patients with both baseline and at least one post-baseline value were included for this analysis.||mg iron (Fe)/g dry weight (dw)||Standard Error|Least Squares Mean
790419|NCT00873041|Secondary|Core Study: Percentage of Participants With Notable Abnormal Post-baseline Laboratory Results|"The percentage of participants with notable laboratory results:
Platelet count: (<100 x 10^9/L)
Absolute neutrophils: (<1.5 x 10^9/L)
Alanine aminotransferase (ALT): (>5 x Upper limit normal (ULN) and >2 x baseline).
Aspartate aminotransferase (AST): (>5 x ULN and >2 x baseline)
Serum creatinine: (>33% increase from baseline and >ULN at ≥2 consecutive post-baseline values) Creatinine clearance: (<60 mL/min at ≥2 consecutive post-baseline values)
Urinary protein/creatinine ratio: (≥ 1.0 mg/mg at ≥2 consecutive post-baseline values)"|52 Weeks|Safety Set included all randomized participants who received treatment.||Percentage of participants|||Number
790420|NCT00873041|Secondary|Core Study: Change in Liver Iron Concentration (LIC) in Placebo Patients From Baseline to Week 52|LIC was measured by magnetic resonance imaging technique at baseline and Week 52. The change in liver iron concentration for participants in the placebo arm was used to assess the iron accumulation rate.|Baseline, Week 52|Safety Analysis Set. The last available post-baseline LIC was carried forward if no LIC value was available at Week 52. Only patients with both baseline and at least one post-baseline value were included for this analysis.||mg iron (Fe)/g dry weight (dw)||Standard Deviation|Mean
790421|NCT00873041|Secondary|Core Study: Change From Baseline in Transferrin Saturation at Month 12|Blood was collected for transferrin saturation at Baseline and Month 12. Change from baseline= Month 12 transferrin saturation - baseline transferrin saturation.|Baseline, Month 12|Full Analysis Set (all randomized patients). Only patients with a value both at baseline and at considered timepoint are included in the analyses.||Percent saturation||Standard Deviation|Mean
790692|NCT00877929|Secondary|Change From Baseline in Trough Seated Systolic Blood Pressure to Week 2|Trough blood pressure measurements were the measurements observed at the end of the dosing interval just prior to the next dose of medication.|Baseline, week 2|||mmHg||Standard Error|Least Squares Mean
790423|NCT00873041|Secondary|Core Study: Correlation Between Serum Ferritin and LIC (Liver Iron Concentration)|"The correlation between serum ferritin and LIC was investigated using a scatter plot with a regression line for the following cases:
Baseline serum ferritin versus baseline LIC
Serum ferritin difference from baseline at fourth quarter versus difference from baseline in LIC at Week 52.
A value of 1.0 indicates a perfect correlation."|Baseline, 52 weeks|Participants from the Full Analysis Set (all randomized participants).||Correlation coefficient|||Number
790424|NCT00873041|Secondary|Core Study: Change in Liver Iron Concentration (LIC) From Baseline At Week 24 and Week 52 in Patients With Dose Increases After Week 24|LIC was measured by magnetic resonance imaging technique at baseline, Week 24 and Week 52. Dose Doubling (Dose Increases) began at Week 24.|Baseline, Week 24, Week 52|Full Analysis Set. The last available post-baseline LIC was carried forward if no LIC value was available at Week 24 and Week 52. Only patients with dose increases after week 24, with both baseline and at least one post-baseline value were included for this analysis.||mg iron (Fe)/g dry weight (dw)||Standard Deviation|Mean
790425|NCT00873041|Secondary|Core Study: Percentage of Participants With Adverse Events Graded Mild, Moderate and Severe|Percentage of Participants with Mild, Moderate and Severe adverse events (AE) any primary system organ class regardless of study drug relationship. A patient with multiple occurrences of an AE is counted only once in the AE category for that treatment. A patient with multiple severity ratings for an AE while on a treatment is only counted once under the maximum rating.|52 Weeks|Safety Analysis Set included all randomized participants who received treatment.||Percentage of participants|||Number
790426|NCT00873041|Secondary|Core Study: Change in Serum Ferritin Between Baseline and Second Quarter|"Baseline serum ferritin average was the average of all available ferritin values from screening to last sample prior to the first intake of study drug.
Second quarter serum ferritin average was the average of all serum ferritin values obtained within days 106-195.
Change from baseline: second quarter serum ferritin average - baseline serum ferritin average."|Baseline, (Day 106 to Day 195)|Full Analysis set (all randomized patients). Only participants with both baseline and post-baseline values are included in analyses. If serum ferritin was missing during the second quarter, the last available average of serum ferritin per quarter was used for the calculation of the change from baseline.||μg/L||Standard Deviation|Mean
790427|NCT00873041|Secondary|Core Study: Change in Serum Ferritin Between Baseline and Fourth Quarter|"Baseline serum ferritin average was the average of all available ferritin values from screening to last sample prior to the first intake of study drug.
Fourth quarter serum ferritin average was the average of all serum ferritin values obtained within days 286- End of Study.
Change from baseline: fourth quarter serum ferritin average - baseline serum ferritin average."|Baseline, (Day 286 to End of Study [Day 365])|Full Analysis set (all randomized patients). Only participants with both baseline and post-baseline values are included in analyses. If serum ferritin was missing during the fourth quarter, the last available average of serum ferritin per quarter was used for the calculation of the change from baseline.||μg/L||Standard Deviation|Mean
790428|NCT00873041|Secondary|Core Study: Change in Liver Iron Concentration (LIC) From Baseline to Week 24|LIC was measured by magnetic resonance imaging technique at baseline and Week 24. Estimates were obtained from an Analysis of Covariance (ANCOVA) model for change in LIC between baseline and Week 24 with treatment as factor and baseline LIC as covariate.|Baseline, Week 24|Full Analysis Set. The last available post-baseline LIC was carried forward if no LIC value was available at Week 24. Only patients with both baseline and at least one post-baseline value were included for this analysis.||mg iron (Fe)/g dry weight (dw)||Standard Error|Least Squares Mean
790429|NCT00873093|Other Pre-specified|Pharmacokinetics (PK) of Bortezomib in Patients Receiving Multi-agent Combination Therapy.|This outcome measure cannot be reported due to the data used for analysis was not collected.|Day 8 of blocks 1 and 2||||||
790430|NCT00873093|Other Pre-specified|Plasma Concentration-time Profiles|Will be analyzed using descriptive statistics and will be graphically displayed by age group and stratum. PK data will be analyzed using methods such as nonlinear mixed effects modeling to estimate bortezomib clearance and volume of distribution (and the associated 95% confidence intervals) in each age group (2-11 years and 12-16 years of age).|Up to day 8 of block 2|These were for correlative biology studies and the data were not collected in COG database.|||||
790431|NCT00873093|Other Pre-specified|Change in Stem Cell Percentage|Will use descriptive statistics to assess mean +/- standard deviation for stem cell percentage before and after bortezomib treatment. If there appears to be a difference in responders vs. non-responders, stem cell percentage differences between responders and non-responders will be compared using a paired t-test or equivalent nonparametric test.|Baseline to post-treatment with bortezomib|These were for correlative biology studies and the data were not collected in COG database.|||||
790432|NCT00873093|Other Pre-specified|Expression of Apoptotic and Cell Cycle Proteins Assessed by Using Gene and Tissue Microarrays and Immunoblots|Characterized using descriptive statistics. If differences are noted between pre- and post-treatment protein expression, pairwise comparisons will be made using paired t-test or an equivalent nonparametric test. The normality assumption will be assessed on the log-transformed data prior to paired t-test evaluation.|Up to 5 years|These were for correlative biology studies and the data were not collected in COG database.|||||
790433|NCT00873093|Other Pre-specified|NF-kB Activity|NF-kB activity will be measured as a continuous variable (ng NF-kB/ug protein). Differences in NF-kB activity between time points will be assessed using summary statistics such as mean, standard deviation, and range.|Up to 5 years|These were for correlative biology studies and the data were not collected in COG database.|||||
790434|NCT00873093|Secondary|Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 3|Percentage of eligible and evaluable patients with MRD < 0.01% among those who had successful MRD determination at the end of Block 3.|End of Block 3 (Day 36 of Block 3) of re-induction therapy|The MRD analysis is limited to eligible and evaluable pre-B ALL with age <= 21 years who relapsed < 36 months only (stratum 1 & 2) and have successful MRD determination at the end of Block 3per protocol section 9.3.3.||Percentage of participants|||Number
790435|NCT00873093|Secondary|Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 2|Percentage of eligible and evaluable patients with MRD < 0.01% among those who had successful MRD determination at the end of Block 2.|End of Block 2 (Day 36 of Block 2) of re-induction therapy|The MRD analysis is limited to eligible and evaluable pre-B ALL with age <= 21 years who relapsed < 36 months only (stratum 1 & 2) and have successful MRD determination at the end of Block 2per protocol section 9.3.3.||percentage of participants|||Number
790436|NCT00873093|Secondary|Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 1|Percentage of eligible and evaluable patients with MRD < 0.01% among those who had successful MRD determination at the end of Block 1.|End of Block 1 (Day 36 of Block 1) of re-induction therapy|The MRD analysis is limited to eligible and evaluable pre-B ALL with age <= 21 years who relapsed < 36 months only (stratum 1 & 2) and have successful MRD determination at the end of Block 1per protocol section 9.3.3.||percentage of participants|||Number
790437|NCT00873093|Primary|Severe Adverse Events (SAE) Rate.|The proportion of SAE rate among all eligible patients|4 months|The SAE event was monitored for all eligible patients. It was not compared between subgroups per protocol 9.3.2.||percentage of participants|||Number
790438|NCT00873093|Primary|Toxic Death Rate|The proportion of toxic death rate among all eligible patients.|4 months|The toxic death was monitored for all eligible patients. It was not compared between subgroups per protocol 9.3.2.||percentage of participants|||Number
790439|NCT00873093|Primary|Event Free Survival|Percentage of patients who were event free at 4 months|4 months after enrollment|The analysis on this primary outcome is limited to pre-B ALL with age <= 21 years who relapsed < 36 months only (stratum 1 & 2) per protocol section 9.2.1.||Percentage of participants|||Number
790440|NCT00873093|Primary|Second Complete Remission Rate at the End of Block 1 Reinduction Chemotherapy|The percentage of eligible and evaluable patients who have achieved complete response at the end Block 1 of re-induction therapy.|The outcome is measured the end of Block 1 (Day 36 of Block 1) of re-induction therapy.|The analysis on this primary outcome is limited to pre-B ALL with age <= 21 years who relapsed < 36 months only (stratum 1 & 2) per protocol section 9.2.1.||Percentage of participants|||Number
790441|NCT00873119|Secondary|Time to Progression (TTP)|Time from the date of randomization to the time of disease progression|Tumor assessment every 6 weeks for the treatment period. Subsequent assessments every 6 weeks for the initial 6 months, then every 9 weeks for 6 months, then every 12 weeks for 12 months and then every 6 months until 5 years from the start of study|Intent-to-treat (ITT) population: All patients randomized to one of the two treatment groups were included in the ITT population. 26 patients (12 in Arm A and 14 in Arm B) were censored. One patient in each arm had no information reported.||months||95% Confidence Interval|Median
790442|NCT00873119|Secondary|Duration of Response|Duration of overall response was measured from the time that measurement criteria were first met for CR or PR (whichever status was recorded first) until the first date that PD ([Progressive Disease]) or death was documented|Tumor assessment every 6 weeks for the treatment period. Subsequent assessments every 6 weeks for the initial 6 months, then every 9 weeks for 6 months, then every 12 weeks for 12 months and then every 6 months until 5 years from the start of study|Intent-to-treat (ITT) population: All patients randomized to one of the two treatment groups were included in the ITT population. Three patients, 2 in Arm A and 1 in Arm B, were not treated with study medication||months||95% Confidence Interval|Median
790443|NCT00873119|Secondary|Time to Response|For patients with overall best response being CR or PR, time to response was measured as the time from randomization to the first time when the measurement criteria for CR or PR (whichever status is recorded first) were met|Tumor assessment every 6 weeks for the treatment period. Subsequent assessments every 6 weeks for the initial 6 months, then every 9 weeks for 6 months, then every 12 weeks for 12 months and then every 6 months until 5 years from the start of study|Patients with overall best response being either complete response or partial response.||months||Full Range|Median
790444|NCT00873119|Secondary|Overall Survival (OS)|Time from the date of randomization to the date of death|Tumor assessment every 6 weeks for the treatment period. Subsequent assessments every 6 weeks for the initial 6 months, then every 9 weeks for 6 months, then every 12 weeks for 12 months and then every 6 months until 5 years from the start of study|Intent-to-treat (ITT) population: All patients randomized to one of the two treatment groups were included in the ITT population. 18 patients (10 in Arm A and 8 in Arm B) were censored.||months||95% Confidence Interval|Median
790445|NCT00873119|Secondary|Best Overall Response|The best overall response in an individual patient according to the RECIST criteria (Eisenhauer 2009 ) is the best response recorded from the start of the treatment until disease progression/recurrence. Objective response is defined as best overall response of complete response (CR) or partial response (PR)|Tumor assessment every 6 weeks for the treatment period. Subsequent assessments every 6 weeks for the initial 6 months, then every 9 weeks for 6 months, then every 12 weeks for 12 months and then every 6 months until 5 years from the start of study|Intent-to-treat (ITT) population: All patients randomized to one of the two treatment groups were included in the ITT population.||percentage of participants|||Number
790446|NCT00873119|Primary|Progression Free Survival|Time from the date of randomization to the time of disease progression or death due to any cause, measured by RECIST criteria (Response Evaluation Criteria In Solid Tumors).|Tumor assessment every 6 weeks for the treatment period. Subsequent assessments every 6 weeks for the initial 6 months, then every 9 weeks for 6 months, then every 12 weeks for 12 months and then every 6 months until 5 years from the start of study|Intent-to-treat (ITT) population: All patients randomized to one of the two treatment groups were included in the ITT population, 12 patients (5 in Arm A and 7 in Arm B) were censored due to lack of efficacy||months||95% Confidence Interval|Median
790447|NCT00875550|Secondary|Time to Successful Extubation||6 to 24 hours|Efficacy Evaluable Population: All subjects randomized to study medication and who received randomized DEX for at least 6 hours||Hours||95% Confidence Interval|Median
790448|NCT00875550|Secondary|Time to First Dose of Rescue Medication for Sedation and Analgesia||6 to 24 hours|Efficacy Evaluable Population: All subjects randomized to study medication and who received randomized DEX for at least 6 hours||Hours||95% Confidence Interval|Median
790449|NCT00875550|Secondary|Total Amount of Rescue Medication Required for Sedation and Analgesia While Intubated||6 to 24 hours|Efficacy Evaluable Population: All subjects randomized to study medication and who received randomized DEX for at least 6 hours||Milligram||Standard Deviation|Mean
790450|NCT00875550|Secondary|Absolute Time on Study Drug That the Subject is Out of the Target Sedation Range (UMSS <1 or >3) While Intubated||6 to 24 hours|Efficacy Evaluable Population: All subjects randomized to study medication and who received randomized DEX for at least 6 hours||hours||Full Range|Median
790451|NCT00875550|Secondary|Absolute Time on Study Drug That the Subject is in a UMSS Range of 1 to 3 While Intubated||6 to 24 hours|Efficacy Evaluable Population: All subjects randomized to study medication and who received randomized DEX for at least 6 hours||Hours||Full Range|Median
790452|NCT00875550|Primary|Percentage of Subjects That do Not Require Rescue Midazolam (MDZ) for Sedation Based on Achieving and Maintaining a Target University of Michigan Sedation Scale (UMSS) Score of 1 to 3 While Intubated.|"Clinical Score Level of Sedation 0 Awake/Alert
Minimally Sedated: Tired/sleepy, appropriate response to verbal conversation and/or sounds.
Moderately Sedated: Somnolent/sleeping, easily aroused with light tactile stimulation.
Deeply sedated: Deep sleep, arousable only with significant physical stimulation.
Unarousable"|6 to 24 hours|Efficacy Evaluable Population: All subjects randomized to study medication and who received randomized DEX for at least 6 hours||Percentage of subjects|||Number
790453|NCT00875563|Primary|Number of Participants With Treatment Success|"Technical success (successful access, deployment, and patency of the Fenestrated Graft, and patency of all vessels targeted by a fenestration intra-operatively), and freedom from the following: type I or type III endoleaks, AAA-related serious adverse events, AAA-related major complications, and aneurysm enlargement greater than 0.5 cm.
A serious adverse event is defined as any occurrence of death, aneurysm rupture, or conversion to open surgical repair.
A major complication is defined as any occurrence of Q-wave myocardial infarction, congestive heart failure, cardiac ischemia requiring intervention, renal failure requiring permanent dialysis, bowel obstruction, ischemia, or fistula, stroke with permanent deficit, or paralysis."|6 months|Two patients were lost to follow-up and did not have CT data at 6 months. Patients treated with the Zenith® Fenestrated AAA Endovascular Graft was compared to propensity score matched patients treated with the Zenith® AAA Endovascular Graft (NCT00196092, link to 5-year study results provided).||participants|||Number
790454|NCT00875589|Primary|Stability of Fixation|The ability to keep eye position fixed on a visual target, measured by the distance between the target and eye fixation point averaged over 20 sec.|During eye movement recording session (20 sec).|Although there were 15 participants in the Control arm, data were only analyzed for a cohort of 11 that were age-matched to the MTBI arm participants.||degrees||Standard Deviation|Mean
790455|NCT00875615|Secondary|Number of Patients Achieving Clinical Benefit|Number of patients achieving complete or partial response according to RECIST criteria|36 months|Of the 11 participants enrolled, 10 had results that were evaluable.||participants|||Number
790456|NCT00875615|Primary|Number of Subjects Experiencing Adverse Events|The number of subjects experiencing adverse events after receiving protocol therapy.|36 months|Of the 11 participants enrolled, 10 had results that were evaluable.||participants|||Number
790457|NCT00875706|Primary|Number of Participants in Pilot Interviews|This outcome measures the number of participants that participated in interviews that were conducted during the pilot in order to assess the feasibility of conducting a larger study.|This outcome was assessed at the end of the 1 year pilot study.|Only participants in the Data Collection - Interview group were analyzed for this outcome. The population included trainees and direct care workers.||participants|||Number
790458|NCT00875706|Primary|Number of Participants in Pilot Surveys|This outcome measures the number of participants that completed the survey during the pilot in order to assess the feasibility of conducting a larger study.|This outcome was assessed at the end of the 1 year pilot study.|Only participants in the Data Collection - Survey group were analyzed for this outcome. The population included trainees and direct care workers.||participants|||Number
790459|NCT00875706|Primary|Facility Implementation of Trainings|This measure assesses the number of participating facilities (4) that implemented trainings in their own facilities upon completion of our educational training intervention.|This outcome was assessed at the end of the 1 year pilot study.|This unit of measure for this outcome measure is at the facility level. There were 4 facilities (8 trainees) in total that began the training intervention.||Facility|Participants||Number
790460|NCT00875706|Primary|Completion of Training Intervention|This outcome measures the number of participants that fully completed the training intervention.|This outcome was assessed at the end of the 1 year pilot study.|The analysis population includes only participants who started the Train-the-Trainer intervention and therefore only participants in the Training Feasibility Arm/Group were analyzed for this outcome.||participants|||Number
790461|NCT00875797|Secondary|6-month Survival|Six month follow up|6 month|||participants|||Number
790462|NCT00875797|Secondary|Infection Rate at Participants in Both Groups|Number of infections that occured at participants during study.|participants were followed for the duration of ICU stay (average 3 weeks)|||number of infections|||Number
790463|NCT00875797|Primary|Intestinal Permeability - Lactulose-mannitol(L/M)Test|"Measurement of intestinal permeability using lactulose-mannitol test (L/M test).
Intestinal permeability to sugars is an accurate test for detecting intestinal damage. Intestinal permeability of the epithelium to very small sugar molecules such as lactulose/mannitol may give useful information regarding the overall condition of the digestive tract.
Mannitol is absorbed transcellularly and lactulose has a paracellular route of absorption. Reduction in mannitol absorption shows reduced surface area and increased lactulose absorption indicates a leaky gut.
Lactulose and mannitol are given orally and later determined from the collected urine with HPTLC (high performance thin layer chromatography). The L/M ratio, as a result of lactulose-mannitol tests, is then calculated regarding urine lactulose and mannitol concentrations.
Thus, with the lactulose/mannitol test the intestinal permeability changes due to different reasons can be evaluated."|4 days after admission to intensive care unit|||L/M ratio||Standard Deviation|Mean
790464|NCT00875810|Secondary|Intervertebral Disc Space||2 years|As this is an observational study not all patients had images available for each visit, for this reason the number of participants analyzed is different from the number of patients in the Participant Flow.||millimiters||Standard Deviation|Mean
790475|NCT00876018|Secondary|Change From Baseline in Folate Level After 4 Months|Folate level was measured as micronutrient markers in study participants.|Baseline, after 4 months|Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.||nanogram per mililitre (ng/mL)||Inter-Quartile Range|Median
790476|NCT00876018|Secondary|Change From Baseline in Vitamin B12 Level After 4 Months|Vitamin B12 was measured by electrochemilumenesence method as micronutrient markers in study participants.|Baseline, after 4 months|Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.||picomole per litre(pmol/L)||Inter-Quartile Range|Median
790465|NCT00875810|Primary|Neck Disability Index (NDI) Score|"The primary objective is the documentation of QoL before and after cervical disc surgery using the PRESTIGE® Cervical Disc System. The QoL will be determined using the EQ-5D questionnaire and the Neck Disability Index (NDI).
The NDI is a self-reported questionnaire designed to provide information on how neck pain affects the patient's ability to manage in everyday life. It contains questions on 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation.
NDI results can be presented as a raw score or as a percent. When presenting it as a raw score, each section is scored on a 0 to 5 rating scale and the result is summarized to a total score with a maximum score of 50. This raw score can also be doubled and expressed as a percentage. Zero points or 0% means no activity limitations and 50 points or 100% means complete activity limitation."|2 years|As this is an observational study not all patients completed NDI questionnaires, for this reason the number of participants analyzed is different from the number of patients in the Participant Flow.||units on a scale||Standard Deviation|Mean
790466|NCT00875810|Secondary|Duration of Pain Prior to Enrollment|Documentation of duration of pain prior to enrollment|Baseline visit|||percentage of patients with pain|||Number
790467|NCT00875810|Primary|EQ-5D|"The primary objective is the documentation of QoL before and after cervical disc surgery using the PRESTIGE® Cervical Disc System. The QoL will be determined using the EQ-5D questionnaire and the Neck Disability Index (NDI).
EQ-5D is an instrument for measuring health outcome and consists of five dimensions: mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression and a Visual Analog Scale that can be used as a quantitative measure of health as judged by the patient. Each dimension has 3 levels (no problems = 1, some problems = 2, and extreme problems = 3). The EQ-5D index has an upper limit of 1 that indicates full health (indicated by “no problem” in all domains), whereas 0 represents death. Scores worst than 0 are possible, implying that some health states may be worse than death."|2 years|As this is an observational study not all patients completed EQ-5D questionnaires, for this reason the number of participants analyzed is different from the number of patients in the Participant Flow.||units on a scale||Standard Deviation|Mean
790468|NCT00875836|Secondary|Marijuana Craving|The Marijuana Craving Questionnaire (MCQ) is intended to measure marijuana craving in adults. It measures symptoms on four subscales: expectancy, purposefulness, emotionality, and compulsivity. The scale rates individual items from 1 (least craving) – 7 (most craving) with a composite scoring range of 12-84 and possible subscale scoring range of 3-21. It was administered weekly- reported here is the mean composite score across the 8 week treatment course.|8 Weeks|||units on a scale||95% Confidence Interval|Mean
790469|NCT00875836|Secondary|Retention in the Study|Number of days subjects remained active in the study|participants were followed for twelve weeks|||Day||Inter-Quartile Range|Median
790470|NCT00875836|Primary|Percent Marijuana-negative Urine Drug Screens (UDS)|Participants submitted a urine sample weekly. Percentage of marijuana negative urine samples were calculated per group.|Participants provided a once-weekly urine sample for twelve weeks|||percentage of UDS|Participants||Number
790471|NCT00875979|Secondary|Progression-free Survival Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)|Progression-free survival was defined as the time from randomization to first documented disease progression (PD) or death due to any cause within 30 days of the last treatment, whichever occurred first. For target lesions, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Target lesions should be selected on the basis of their size (those with the longest diameter) and their suitability for accurate repeated measurements by imaging techniques or clinically. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions.|Baseline through the end of the study (up to 2 years 3 months)|Treated population: All enrolled patients.||Months||95% Confidence Interval|Median
790472|NCT00875979|Secondary|Duration of Objective Response Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)|Duration of objective response was defined as the time from initial response to disease progression (PD) or death from any cause. For target lesions, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Target lesions should be selected on the basis of their size (those with the longest diameter) and their suitability for accurate repeated measurements by imaging techniques or clinically. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions.|Baseline through the end of the study (up to 2 years 3 months)|Treated population: All enrolled patients who had baseline measureable disease. Only patients with an objective response were included in the analysis.||Months||95% Confidence Interval|Median
790473|NCT00875979|Primary|Objective Response Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)|A patient had an objective response if they had a complete response or a partial response on 2 consecutive occasions ≥ 4 weeks apart. For target lesions, a complete response was defined as the disappearance of all target lesions; a partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. For non-target lesions, a complete response was defined as the disappearance of all non-target lesions; a partial response was defined as the persistence of 1 or more non-target lesions.|Baseline through the end of the study (up to 2 years 3 months)|Treated population: All enrolled patients who had baseline measureable disease.||Percentage of patients||95% Confidence Interval|Number
790474|NCT00876018|Secondary|Change From Baseline in Vitamin C Level After 4 Months|Vitamin C level was measured as micronutrient markers in study participants.|Baseline, after 4 months|Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.||miligram per decilitre (mg/dL)||Inter-Quartile Range|Median
790693|NCT00877929|Secondary|Change From Baseline in Trough Seated Systolic Blood Pressure to Week 4|Trough blood pressure measurements were the measurements observed at the end of the dosing interval just prior to the next dose of medication.|Baseline, week 4|||mmHg||Standard Error|Least Squares Mean
790477|NCT00876018|Secondary|Change From Baseline in Vitamin B6 Level After 4 Months|Vitamin B6 level was measured as micronutrient markers in study participants.|Baseline, after 4 months|Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.||nano mole per litre (nmol/L)||Inter-Quartile Range|Median
790478|NCT00876018|Secondary|Change From Baseline in Vitamin B2 Level After 4 Months|Vitamin B2 level was measured by erythrocyte glutathione reductase coefficient (EGRAC) method as micronutrient markers in study participants.|Baseline, after 4 months|Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.||ratio||Inter-Quartile Range|Median
790479|NCT00876018|Secondary|Change From Baseline in C-reactive Protein Level After 4 Months|C-reactive protein level was measured.|Baseline, after 4 months|Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.||mg/L||Inter-Quartile Range|Median
790480|NCT00876018|Secondary|Change From Baseline in Soluble Transferring Receptors (sTr) After 4 Months|Soluble transferring receptors (sTr) was measured to assess the iron status of study participants.|Baseline, after 4 months|Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.||miligram per litre (mg/L)||Inter-Quartile Range|Median
790481|NCT00876018|Secondary|Change From Baseline in Ferritin Level After 4 Months|Ferritin level was measured to assess the iron status of study participants.|Baseline, after 4 months|Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.||nanogram per mililitre (ng/mL)||Inter-Quartile Range|Median
790482|NCT00876018|Secondary|Change From Baseline in Hemoglobin Level After 4 Months|Hemoglobin level was measured to assess the iron status in study participants.|Baseline, after 4 months|Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.||gram per decilitre (g/dl)||Inter-Quartile Range|Median
790483|NCT00876018|Secondary|Change From Baseline in Rate of Decline of Muscle Strength After 4 Months|Rate of decline of muscle strength was assessed to measure the muscle endurance of forearm. Sustained isometric contraction of forearm flexors to 50% of maximal handgrip was measured using the Jamar hand dynamometer and was performed on the non-dominant arm. The participant was required to sustain a maximal contraction until the force dropped to 50% of its maximal value. Rate of decline of muscle strength was calculated as 50 percent of maximal value of contraction divided by time to fatigue (50%maximal value of contraction (MVC)/Time to fatigue).|Baseline, after 4 months|Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.||kg/sec||Standard Deviation|Mean
790484|NCT00876018|Secondary|Change From Baseline in Time to Fatigue After 4 Months|Time to fatigue is defined as the time in seconds taken for the handgrip to fall from maximal value to 50% of the maximal value. Time to fatigue was measured using Jamar hand dynamometer to assess the muscle strength. In this test, participants were required to sustain a maximal contraction until the force dropped to 50% of its maximal value.|Baseline, after 4 months|Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.||sec||Standard Deviation|Mean
790485|NCT00876018|Secondary|Change From Baseline in Maximal Handgrip Strength for Dominant and Non-dominant Hand After 4 Months|Maximal handgrip strength was measured using a Jamar handgrip dynamometer in dominant and non-dominant arms. The width of the grip was noted during the pre-intervention assessment and kept constant for an individual during the subsequent post-intervention assessment. Muscle strength was recorded as the best (highest) value for the dominant and non-dominant sides as well as average value of the 3 measurements.|Baseline, after 4 months|Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.||kg||Standard Deviation|Mean
790486|NCT00876018|Primary|Change From Baseline in Visual Reaction Time After 4 Months|Visual reaction time was assessed using a customized computer based programme. Participant was provided with a periodic random test visual stimulus among many other ‘non test’ stimuli. Participant was required to tap the space bar of the computer as fast as possible on the appearance of the test visual stimulus. Three test visual cues were provided at each sitting to allow for training effects. The shortest visual reaction time of the three visual cues was used in analyses.|Baseline, after 4 months|Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.||milliseconds (msec)||Standard Deviation|Mean
790487|NCT00876018|Primary|Change From Baseline in Time Taken for 40 Meter (m) Sprint After 4 Months|A 40m sprint was used to assess speed with time taken to complete the sprint being recorded manually using a digital stopwatch. The moment any part of the designated participant’s body reached the marker level, the corresponding examiner stopped their watches and recorded the time for the sprint.|Baseline, after 4 months|Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.||seconds (Sec)||Standard Deviation|Mean
790511|NCT00876460|Secondary|Cmax of Docetaxel in Course 1|Cmax (maximum measured plasma concentration) after the first administration of docetaxel in course 1|-0:05h before drug administration and 1h, 1.5h, 2h, 3h, 4h, 7h, 23:55h and 47:55h after drug administration|Treated set (1 patient was replaced after completion of first administration of docetaxel and before any nintedanib intake. PK sampling of docetaxel for this patient was done and included in PK analysis.)||ng/mL||Geometric Coefficient of Variation|Geometric Mean
790488|NCT00876018|Primary|Change From Baseline in Aerobic Capacity-shuttle Test (VO2peak) After 4 Months|Aerobic capacity(VO2peak) is defined as maximum rate of oxygen consumption attained on a particular exercise test. VO2peak was measured by 20m shuttle run test to assess aerobic & whole body endurance. In this test, participants were asked to move around one cone to another placed at 19m distance, reversing direction & in accordance with a pace dictated by sound signal, that got progressively faster at one minute intervals. The initial pace was set at 4.0 km/hr & with subsequent increases of 0.5 km/hr every subsequent minute. This test was conducted in groups (of at least 3 children per group). The shuttle was stopped when either the participant chose to stop because of exhaustion or when participant was > 1m away from cone at 2 consecutive paced signals. The number of shuttles at stoppage was noted. VO2peak was calculated as 31.025 + (3.325 x speed) – (3.248 x age). Speed is speed attained in previous level of shuttle, computed as speed (km/hr) = v + 0.5 x n/60; and age is in years.|Baseline, after 4 months|Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.||km/hr*years||Standard Deviation|Mean
790489|NCT00876018|Primary|Change From Baseline in Maximal Aerobic Capacity (VO2max)- 12 Inch Step Test After 4 Months|Maximal aerobic capacity (VO2max) is defined as the maximum rate of oxygen consumption, measured during incremental exercise. VO2max was measured with the help of an externally placed 12-inch step test to assess the aerobic fitness/cardio-respiratory endurance of the study participants. In this test, participants were asked to step at 22 steps a minute for 3 minutes. The pulse rate was recorded manually, within 15sec of stopping the test. VO2max was calculated as (VO2 x HRmax) divided by HR observed, where HRmax = 220-Age in years. HRmax= maximum heart rate. VO2 is equal to (0.2 x Stepping Rate) + (2.4 x Step height x Stepping Rate) + 3.5 mL/kg/min. mL/kg/min.= milliliter per kilogram per minute.|Baseline, after 4 months|Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.||mL/kg/min.||Standard Deviation|Mean
790490|NCT00876265|Primary|Adjusted (LS) Mean Change From Baseline in Wrinkle Severity Rating Scale (SRS) Score of Each Nasolabial Fold (NLF) as Determined by the Blinded Evaluator at Week 12.|The severity of the nasolabial folds was measured using the wrinkle Severity Rating Scale (SRS), where 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Extreme, which is an ordinal scale.|Baseline and Week 12 of follow-up|The Full Analysis Set (FAS) population was the analysis population which was defined as all subjects who were randomized and received at least one injection of the study device to the nasolabial folds.||Wrinkle Severity Rating Score (SRS)||Standard Error|Least Squares Mean
790491|NCT00876343|Secondary|Mean Change in Sheehan Disability Scale (SDISS)|"The endpoint evaluated the change in SDISS from the end of the SSRI/SNRI treatment period to Week 6 of the placebo-controlled, double-blind treatment period.
The patient rates the extent to which his or her 1) work, 2) social life or leisure activities, and 3) home life or family responsibilities are impaired by his or her symptoms on a 10-point visual analog scale. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired)."|Baseline (the end of the SSRI/SNRI treatment period), at completion of administration|||Rating score||Standard Error|Mean
790492|NCT00876343|Secondary|MADRS Response Rate|The percentage of subjects with a decrease in MADRS total score of 50% or more, from the end of the SSRI/SNRI treatment period to the end of the placebo-controlled, double-blind treatment period (or withdrawal).|Baseline (the end of the SSRI/SNRI treatment period), at completion of administration|||percentage of subjects|||Number
790493|NCT00876343|Primary|Mean Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|"The change in MADRS total score from the end of the SSRI/SNRI treatment period to Week 6 of the placebo-controlled, double-blind treatment period by covariance analysis, and compared the aripiprazole variable dose group with the placebo group as well as the aripiprazole fixed dose group with the placebo group.
Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.
The questionnaire includes questions on the following symptoms
1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts"|Baseline (the end of the SSRI/SNRI treatment period), at completion of administration|||Rating score||Standard Error|Mean
790494|NCT00876447|Secondary|Change From Study Baseline in Volume Per Void|The total volume voided (voluntary or by catheterization) is recorded by the patient over a 24-hour period preceding the study visit. The average volume per voiding episode is derived by dividing the total volume collected in a 24-hour period by the total number of urinary episodes with volume recorded in the same 24-hour period. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improvement.|Study Baseline, Week 6 Treatment Cycle 5|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received||Milliliters (mL)||Standard Deviation|Mean
790495|NCT00876447|Secondary|Change From Study Baseline in Volume Per Void|The total volume voided (voluntary or by catheterization) is recorded by the patient over a 24-hour period preceding the study visit. The average volume per voiding episode is derived by dividing the total volume collected in a 24-hour period by the total number of urinary episodes with volume recorded in the same 24-hour period. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improvement.|Study Baseline, Week 6 Treatment Cycle 4|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received||Milliliters (mL)||Standard Deviation|Mean
790512|NCT00876460|Secondary|AUC0-inf of Docetaxel in Course 1|AUC0-inf (area under the plasma concentration-time curve over the time interval from 0 extrapolated to infinity) after the first administration of docetaxel in course 1|-0:05h before drug administration and 1h, 1.5h, 2h, 3h, 4h, 7h, 23:55h and 47:55h after drug administration|Treated set (1 patient was replaced after completion of first administration of docetaxel and before any nintedanib intake. Pharmacokinetic (PK) sampling of docetaxel for this patient was done and included in PK analysis.)||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
790496|NCT00876447|Secondary|Change From Study Baseline in Volume Per Void|The total volume voided (voluntary or by catheterization) is recorded by the patient over a 24-hour period preceding the study visit. The average volume per voiding episode is derived by dividing the total volume collected in a 24-hour period by the total number of urinary episodes with volume recorded in the same 24-hour period. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improvement.|Study Baseline, Week 6 Treatment Cycle 3|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received||Milliliters (mL)||Standard Deviation|Mean
790497|NCT00876447|Secondary|Change From Study Baseline in Volume Per Void|The total volume voided (voluntary or by catheterization) is recorded by the patient over a 24-hour period preceding the study visit. The average volume per voiding episode is derived by dividing the total volume collected in a 24-hour period by the total number of urinary episodes with volume recorded in the same 24-hour period. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improvement.|Study Baseline, Week 6 Treatment Cycle 2|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received||Milliliters (mL)||Standard Deviation|Mean
790498|NCT00876447|Secondary|Change From Study Baseline in Volume Per Void|The total volume voided (voluntary or by catheterization) is recorded by the patient over a 24-hour period preceding the study visit. The average volume per voiding episode is derived by dividing the total volume collected in a 24-hour period by the total number of urinary episodes with volume recorded in the same 24-hour period. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improvement.|Study Baseline, Week 6 Treatment Cycle 1|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received||Milliliters (mL)||Standard Deviation|Mean
790499|NCT00876447|Secondary|Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score|The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improved QOL.|Study Baseline, Week 6 Treatment Cycle 5|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received||Scores on a Scale||Standard Deviation|Mean
790500|NCT00876447|Secondary|Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score|The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improved QOL.|Study Baseline, Week 6 Treatment Cycle 4|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received||Scores on a Scale||Standard Deviation|Mean
790501|NCT00876447|Secondary|Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score|The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improved QOL.|Study Baseline, Week 6 Treatment Cycle 3|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received||Scores on a Scale||Standard Deviation|Mean
790502|NCT00876447|Secondary|Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score|The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improved QOL.|Study Baseline, Week 6 Treatment Cycle 2|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received||Scores on a Scale||Standard Deviation|Mean
790503|NCT00876447|Secondary|Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score|The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improved QOL.|Study Baseline, Week 6 Treatment Cycle 1|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received||Scores on a Scale||Standard Deviation|Mean
790504|NCT00876447|Primary|Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes|Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-094 (or 7 days prior to each visit in study 191622-515 or 191622-516). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 7 consecutive days prior to the first treatment in either study 191622-515 or 191622-516. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).|Study Baseline, Week 6 Treatment Cycle 5|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received||Incontinence Episodes||Standard Deviation|Mean
790505|NCT00876447|Primary|Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes|Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-094 (or 7 days prior to each visit in study 191622-515 or 191622-516). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 7 consecutive days prior to the first treatment in either study 191622-515 or 191622-516. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).|Study Baseline, Week 6 Treatment Cycle 4|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received||Incontinence Episodes||Standard Deviation|Mean
790506|NCT00876447|Primary|Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes|Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-094 (or 7 days prior to each visit in study 191622-515 or 191622-516). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 7 consecutive days prior to the first treatment in either study 191622-515 or 191622-516. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).|Study Baseline, Week 6 Treatment Cycle 3|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received||Incontinence Episodes||Standard Deviation|Mean
790507|NCT00876447|Primary|Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes|Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-094 (or 7 days prior to each visit in study 191622-515 or 191622-516). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 7 consecutive days prior to the first treatment in either study 191622-515 or 191622-516. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).|Study Baseline, Week 6 Treatment Cycle 2|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received||Incontinence Episodes||Standard Deviation|Mean
790508|NCT00876447|Primary|Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes|Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-094 (or 7 days prior to each visit in study 191622-515 or 191622-516). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 7 consecutive days prior to the first treatment in either study 191622-515 or 191622-516. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).|Study Baseline, Week 6 Treatment Cycle 1|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received||Incontinence Episodes||Standard Deviation|Mean
790509|NCT00876460|Secondary|Cmax of Docetaxel in Course 2|"Cmax (maximum measured plasma concentration) after the first administration of docetaxel in course 2.
Docetaxel 50 mg/m2 patients were assigned to Docetaxel 60 mg/m2 in Cycle 1, but the dose was reduced to 50 mg/m2 in Cycle 2 as defined in the Clinical Trial Protocol."|-0:05h before drug administration and 1h, 1.5h, 2h, 3h, 4h, 7h, 23:55h and 47:55h after drug administration|Treated set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
790510|NCT00876460|Secondary|AUC0-inf of Docetaxel in Course 2|"AUC0-inf (area under the plasma concentration-time curve over the time interval from 0 extrapolated to infinity) after the first administration of docetaxel in course 2.
Docetaxel 50 mg/m2 patients were assigned to Docetaxel 60 mg/m2 in Cycle 1, but the dose was reduced to 50 mg/m2 in Cycle 2 as defined in the Clinical Trial Protocol."|-0:05h before drug administration and 1h, 1.5h, 2h, 3h, 4h, 7h, 23:55h and 47:55h after drug administration|Treated set (AUC0-inf could not be calculated in 1 patient because the elimination phase was not observed in plasma concentration-time profile in this patient.)||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
790513|NCT00876460|Secondary|Cmax of Nintedanib in Course 1|Cmax (maximum measured plasma concentration) after the first administration of nintedanib in course 1|-0:05h before drug administration and 1h, 2h, 3h, 4h, 6h, 7h, 10h and 23:55h after drug administration in course 1|Treated set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
790514|NCT00876460|Secondary|AUC0-inf of Nintedanib in Course 1|AUC0-inf (area under the plasma concentration-time curve over the time interval from 0 extrapolated to infinity) after the first administration of nintedanib in course 1|-0:05 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 7h, 10h and 23:55h after drug administration in course 1|Treated set (AUC0-inf could not be calculated in 5 patients because the elimination phase was not observed in plasma concentration-time profiles in these patients.)||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
790515|NCT00876460|Secondary|Clinical Relevant Abnormalities in Laboratory Parameters|Number of participants with clinically relevant abnormalities in laboratory parameters reported as adverse events|Between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days|Treated set||Participants|||Number
790516|NCT00876460|Secondary|Time to Treatment Failure (TTF)|"For participants with known date of discontinuation of the study treatment (or progression [not necessarily confirmed by tumour imaging; can also be based on any clinical sign of tumour progression] or death): TTF [days] = earlier of date of discontinuation of the study treatment, progression, or death – date the study treatment started + 1.
For participants known to be alive without progression by the end of trial or follow-up visit: TTF (censored) [days] = date when the patient is known to be progression-free and alive – date the study treatment started + 1.
Progression is assessed according to RECIST version 1.0."|Pre-treatment, every 6 weeks from treatment course 3, end of treatment (up to 1367 days)|Treated set||Days||95% Confidence Interval|Median
790517|NCT00876460|Secondary|Progression-Free Survival (PFS)|"For participants with known date of progression or death (of any cause): PFS [days] = earlier of date of progression or death – date the study treatment started + 1.
For participants known to be alive without progression by the end of trial or follow-up visit: PFS (censored) [days] = date of last imaging when the participant is known to be progression-free and alive – date the study treatment started + 1.
Progression is assessed according to RECIST version 1.0."|Pre-treatment, every 6 weeks from treatment course 3, end of treatment (up to 1367 days)|Treated set||Days||95% Confidence Interval|Median
790518|NCT00876460|Secondary|Disease Control|Number of participants with disease control, defined as complete response (CR) or partial response (PR) or stable disease (SD) according to the Response Evaluation Criteria In Solid Tumors (RECIST) 1.0|Pre-treatment, every 6 weeks from treatment course 3, end of treatment (up to 1367 days)|Patients who treated with nintedanib and had both baseline and at least one post-treated tumour measurement by computed tomography (CT) image||Participants|||Number
790519|NCT00876460|Secondary|Objective Tumor Response|Number of participants with objective response defined as complete response (CR) or partial response (PR) according to the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0|Pre-treatment, every 6 weeks from treatment course 3, end of treatment (up to 1367 days)|Patients who were treated with nintedanib and had both baseline and at least one post-treatment tumour measurement by computed tomography (CT) image||Participants|||Number
790520|NCT00876460|Primary|Adverse Events According to Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 for All Courses|"Number of participants with adverse events according to Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 for all courses.
The CTCAE grades are: 1 (mild AE), 2 (moderate AE), 3 (severe AE), 4 (life-threatening or disabling AE), 5 (death related to AE)."|Between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days|Treated set||Participants|||Number
790521|NCT00876460|Primary|Number of Participants Who Experienced Dose Limited Toxicity in Combination Therapy of Nintedanib and Docetaxel|"Number of participants experienced Dose Limited Toxicity (DLT) in combination therapy of nintedanib and docetaxel.
Maximum tolerated dose (MTD) of nintedanib combination with docetaxel were to be determined separately in the patient groups of body surface area (BSA) <1.5 m2 and BSA ≥1.5 m2. The MTD were to be determined as a combination of a dose equal to or less than 200 mg b.i.d. of nintedanib and 60 mg/m2 and 75 mg/m2 every 3 weeks of docetaxel at which either 0 out of 3, 1 out of 6, or 2 out of 6 patients experienced DLT."|During the first treatment course, up to 3 weeks|Treated set (Patients eligible for DLT confirmation)||Participants|||Number
790522|NCT00876694|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) After 12, 24 and 52 Weeks|Trough FEV1 was defined as the mean of the values at 23 h 10 min and 23 h 45 min after dosing at clinic on the previous day. Trough FEV1 was analyzed after 12, 24 and 52 weeks using a mixed model which contained the baseline FEV1 measurement, FEV1 prior to inhalation and FEV1 30 minutes post inhalation of salbutamol as covariates.|After 12, 24 and 52 weeks|The intention-to-treat (ITT) population included all randomized patients who received at least one dose of study drug.||Liters||Standard Error|Least Squares Mean
790523|NCT00876694|Primary|Blood Glucose (mmol/L) 1 Hour Post Dose at Weeks 4, 8, 12, 24, 36, 44, and 52|The least squares mean of the blood glucose in mmol/L at weeks 4, 8, 12, 24, 36, 44 and 52. Mixed model used baseline blood glucose as a covariate.|4, 8, 12, 24, 36, 44, and 52 weeks|The safety population included all patients who received at least one dose of study drug.||mmol/L||Standard Error|Least Squares Mean
790524|NCT00876694|Primary|Serum Potassium (mmol/L) at Weeks 4, 8, 12, 24, 36, 44, and 52|The least squares mean of the serum potassium in mmol/L at weeks 4, 8, 12, 24, 36, 44 and 52. Mixed model used baseline serum potassium as a covariate.|4, 8, 12, 24, 36, 44, and 52 weeks|The safety population included all patients who received at least one dose of study drug.||mmol/L||Standard Error|Least Squares Mean
790525|NCT00876694|Primary|The Number of Participants With a Clinically Notable QTc Interval Value During 52 Weeks of Treatment|"The number of participants with newly occurring or worsening clinically notable QTc Interval value at anytime post baseline.
The QTc interval is calculated using Fridericia's formula: QTc= QT/cube root RR. QTc is the interval between the Q and T waves corrected for heart rate and RR is the interval between two R waves in milliseconds (ms).
Notable QTc interval >450 ms for males and >470 ms for females. The maximum QTc increase from baseline at any time during the study was also tabulated with absolute and relative frequencies for categories 30- 60 ms and >60 ms."|52 weeks|The safety population included all patients who received at least one dose of study drug.||Participants|||Number
790526|NCT00876694|Primary|The Number of Participants With a Clinically Notable Diastolic Blood Pressure During 52 Weeks of Treatment|"The number of participants with newly occurring or worsening clinically notable vital sign: Diastolic blood pressure (mmHg) at anytime post baseline (BL) by treatment.
A Low Diastolic Blood Pressure was defined as a diastolic blood pressure measurement: <40 mmHg or <= to 50 mmHg and a decrease from baseline >= to 15 mmHg.
A High Diastolic Blood Pressure was defined as a diastolic blood pressure measurement: >115 mmHg or >= to 105 mmHg and an increase from baseline >= to 15 mmHg."|52 weeks|The safety population included all patients who received at least one dose of study drug.||Participants|||Number
790527|NCT00876694|Primary|The Number of Participants With a Clinically Notable Systolic Blood Pressure During 52 Weeks of Treatment|"The number of participants with newly occurring or worsening clinically notable vital sign: Systolic Blood Pressure (mmHg) at anytime post baseline (BL) by treatment.
A Low Systolic Blood Pressure was defined as a systolic blood pressure measurement: <75 mmHg or <= to 90 mmHg and a decrease from baseline >= to 20 mmHg.
A High Systolic Blood Pressure was defined as a systolic blood pressure measurement: >200 mmHg or >= to 180 mmHg and an increase from baseline >= to 20 mmHg."|52 weeks|The safety population included all patients who received at least one dose of study drug.||Participants|||Number
790528|NCT00876694|Primary|The Number of Participants With a Clinically Notable Pulse Rate During 52 Weeks of Treatment|The number of participants with newly occurring or worsening clinically notable vital sign: Pulse Rate in beats per minute (bpm) at anytime post baseline (BL) by treatment. Low Pulse Rate was defined as a pulse rate <40 bpm or <= to 50 bpm and a decrease from baseline >= to 15 bpm. High Pulse Rate was defined as a pulse rate >130 bpm or >= to 120 bpm and an increase from baseline >= to 15 bpm.|52 weeks|The safety population included all patients who received at least one dose of study drug.||Participants|||Number
790529|NCT00876733|Secondary|Changes in the Laboratory Data (Haemoglobin) After 36 Months From Baseline|The changes in the laboratory data (Haemoglobin) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 36 months|Patients from TS with evaluable data for Haemoglobin at baseline and at month 36.||g/dL||Standard Deviation|Mean
790530|NCT00876733|Secondary|Changes in the Laboratory Data (Creatinine) After 36 Months From Baseline|The changes in the laboratory data (Creatinine) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 36 months|Patients from TS with evaluable data for Creatinine at baseline and at month 12.||mg/dL||Standard Deviation|Mean
790531|NCT00876733|Secondary|Changes in the Laboratory Data (Gamma GT) After 36 Months From Baseline|The changes in the laboratory data (Gamma glutamyl transferase (Gamma GT)) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 36 months|Patients from TS with evaluable data for Gamma GT at baseline and at month 36.||U/L||Standard Deviation|Mean
790532|NCT00876733|Secondary|Changes in the Laboratory Data (AST) After 36 Months From Baseline|The changes in the laboratory data (Aspartate transminase (AST)) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 36 months|Patients from TS with evaluable data for AST at baseline and at month 36.||U/L||Standard Deviation|Mean
790533|NCT00876733|Secondary|Changes in the Laboratory Data (ALT) After 36 Months From Baseline|The changes in the laboratory data (Alanine transaminase (ALT)) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 36 months|Patients from TS with evaluable data for ALT at baseline and at month 36.||U/L||Standard Deviation|Mean
790534|NCT00876733|Secondary|Changes in the Laboratory Data (Blood Glucose) After 36 Months From Baseline|The changes in the laboratory data (Blood Glucose) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 36 months|Patients from TS with evaluable data for Blood Glucose at baseline and at month 36.||mg/dL||Standard Deviation|Mean
790535|NCT00876733|Secondary|Changes in the Laboratory Data (Triglycerides) After 36 Months From Baseline|The changes in the laboratory data (Triglycerides) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 36 months|Patients from TS with evaluable data for Triglycerides at baseline and at month 36.||mg/dL||Standard Deviation|Mean
790536|NCT00876733|Secondary|Changes in the Laboratory Data (LDL Cholesterol) After 36 Months From Baseline|The changes in the laboratory data ( Low density protein (LDL) Cholesterol) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 36 months|Patients from TS with evaluable data for LDL Cholesterol at baseline and at month 36.||mg/dL||Standard Deviation|Mean
790537|NCT00876733|Secondary|Changes in the Laboratory Data (HDL Cholesterol) After 36 Months From Baseline|The changes in the laboratory data ( High density protein (HDL) Cholesterol) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 36 months|Patients from TS with evaluable data for HDL Cholesterol at baseline and at month 36.||mg/dL||Standard Deviation|Mean
790538|NCT00876733|Secondary|Changes in the Laboratory Data (Total Cholesterol) After 36 Months From Baseline|The changes in the laboratory data (Total Cholesterol) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 36 months|Patients from TS with evaluable data for Total Cholesterol at baseline and at month 36.||mg/dL||Standard Deviation|Mean
790592|NCT00877058|Primary|Self Rated Health|"Self rated health was measured by the question In general would yoy say your health is: excellent, very good, good, fair or poor? Number of participants detoriated in self-rated health has been analysed"|1 year|ITT||participants|||Number
790539|NCT00876733|Secondary|Changes in the Laboratory Data (Haemoglobin) After 12 Months From Baseline|The changes in the laboratory data (Haemoglobin) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 12 months|Patients from TS with evaluable data for Haemoglobin at baseline and at month 12.||g/dL||Standard Deviation|Mean
790540|NCT00876733|Secondary|Changes in the Laboratory Data (Creatinine) After 12 Months From Baseline|The changes in the laboratory data (Creatinine) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 12 months|Patients from TS with evaluable data for Creatinine at baseline and at month 12.||mg/dL||Standard Deviation|Mean
790541|NCT00876733|Secondary|Changes in the Laboratory Data (Gamma GT) After 12 Months From Baseline|The changes in the laboratory data (Gamma glutamyl transferase (Gamma GT)) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 12 months|Patients from TS with evaluable data for Gamma GT at baseline and at month 12.||U/L||Standard Deviation|Mean
790542|NCT00876733|Secondary|Changes in the Laboratory Data (AST) After 12 Months From Baseline|The changes in the laboratory data (Aspartate transminase (AST)) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 12 months|Patients from TS with evaluable data for AST at baseline and at month 12.||U/L||Standard Deviation|Mean
790543|NCT00876733|Secondary|Changes in the Laboratory Data (ALT) After 12 Months From Baseline|The changes in the laboratory data (Alanine transaminase (ALT)) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 12 months|Patients from TS with evaluable data for ALT at baseline and at month 12.||U/L||Standard Deviation|Mean
790544|NCT00876733|Secondary|Changes in the Laboratory Data (Blood Glucose) After 12 Months From Baseline|The changes in the laboratory data (Blood Glucose) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 12 months|Patients from TS with evaluable data for Blood Glucose at baseline and at month 12.||mg/dL||Standard Deviation|Mean
790545|NCT00876733|Secondary|Changes in the Laboratory Data (Triglycerides) After 12 Months From Baseline|The changes in the laboratory data (Triglycerides) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 12 months|Patients from TS with evaluable data for Triglycerides at baseline and at month 12.||mg/dL||Standard Deviation|Mean
790546|NCT00876733|Secondary|Changes in the Laboratory Data (LDL Cholesterol) After 12 Months From Baseline|The changes in the laboratory data ( Low density protein (LDL) Cholesterol) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 12 months|Patients from TS with evaluable data for LDL Cholesterol at baseline and at month 12.||mg/dL||Standard Deviation|Mean
790547|NCT00876733|Secondary|Changes in the Laboratory Data (HDL Cholesterol) After 12 Months From Baseline|The changes in the laboratory data ( High density protein (HDL) Cholesterol) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 12 months|Patients from TS with evaluable data for HDL Cholesterol at baseline and at month 12.||mg/dL||Standard Deviation|Mean
790548|NCT00876733|Secondary|Changes in the Laboratory Data (Total Cholesterol) After 12 Months From Baseline|The changes in the laboratory data (Total Cholesterol) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 12 months|Patients from TS with evaluable data for Total Cholesterol at baseline and at month 12.||mg/dL||Standard Deviation|Mean
790549|NCT00876733|Secondary|Changes in the CD4+ Cell Count After 36 Months From Baseline.|The change in the CD4+ cell count from baseline after 36 months was calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase in CD4+ cell count.|Baseline and 36 months|Patients from FAS with values for CD4+ at baseline and after 36 months.||cells/mm^3||Standard Deviation|Mean
790550|NCT00876733|Secondary|Changes in the Cluster of Differentiation 4 (CD4+) Cell Count After 12 Months From Baseline.|The change in the CD4+ cell count from baseline after 12 months was calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase in CD4+ cell count.|Baseline and 12 months|Patients from FAS with values for CD4+ at baseline and after 12 months.||cells/mm^3||Standard Deviation|Mean
790551|NCT00876733|Secondary|Changes in the Viral Load After 36 Months From Baseline.|The change in the log10 viral load from baseline after 36 months was calculated by subtracting the baseline value from the value after 36 months. Therefore, a negative change represents a decrease in viral load.|Baseline and 36 months|Patients from FAS with values for viral load at baseline and after 36 months.||Log10 copies/ml||Standard Deviation|Mean
790552|NCT00876733|Secondary|Changes in the Viral Load After 12 Months From Baseline.|The change in the log10 viral load from baseline after 12 months was calculated by subtracting the baseline value from the value after 12 months. Therefore, a negative change represents a decrease in viral load.|Baseline and 12 months|Patients from FAS with values for viral load at baseline and after 12 months.||Log10 copies/ml||Standard Deviation|Mean
790553|NCT00876733|Primary|Number of Participants With Treatment Emergent Adverse Events (AE) and All Serious AEs|Number of participants with Treatment Emergent Adverse Events (AE) and All Serious AEs|36 months|Patients from Full Analysis Set (FAS): This patient set includes all patients in the treated set who have analysable data in at least one efficacy endpoint.||participants|||Number
790554|NCT00876915|Secondary|The Value of Thrombin Antithrombin (TAT) at Baseline Prior to Chemotherapy in Ambulatory Cancer Patients|Blood samples were obtained to measure the value of TAT at baseline compared between high risk for VTE and low risk for VTE ambulatory cancer patients|baseline value of TAT|From 98 high risk patients, 89 provided blood samples used for this analysis. From the low risk group, all 101 subjects provided blood samples for analysis.||ug/L||Standard Deviation|Mean
790555|NCT00876915|Secondary|The Value of Factor VIIa (FVIIa) at Baseline Prior to Chemotherapy in Ambulatory Cancer Patients|Blood samples were obtained to measure the value of FVIIa at baseline compared between high risk for VTE and low risk for VTE ambulatory cancer patients|baseline value of FVIIa|From 98 high risk patients, 89 provided blood samples used for this analysis. From the low risk group, all 101 subjects provided blood samples for analysis.||pM||Standard Deviation|Mean
790556|NCT00876915|Secondary|The Value of Tissue Factor Pathway Inhibitor (TFPI) at Baseline Prior to Chemotherapy in Ambulatory Cancer Patients|Blood samples were obtained to measure the value of TFPI at baseline compared between high risk for VTE and low risk for VTE ambulatory cancer patients|baseline value of TFPI|From 98 high risk patients, 89 provided blood samples used for this analysis. From the low risk group, all 101 subjects provided blood samples for analysis.||pg/mL||Standard Deviation|Mean
790557|NCT00876915|Secondary|The Value of Human F12 at Baseline Prior to Chemotherapy in Ambulatory Cancer Patients|Blood samples were obtained to measure the value of Human F12 at baseline compared between high risk for VTE and low risk for VTE ambulatory cancer patients|baseline value of Human F12|From 98 high risk patients, 89 provided blood samples used for this analysis. From the low risk group, all 101 subjects provided blood samples for analysis.||ng/mL||Standard Deviation|Mean
790558|NCT00876915|Secondary|The Value of D-Dimer at Baseline Prior to Chemotherapy in Ambulatory Cancer Patients|Blood samples were obtained to measure the value of D-Dimer at baseline compared between high risk for VTE and low risk for VTE ambulatory cancer patients|baseline value of D-Dimer|From 98 high risk patients, 89 provided blood samples used for this analysis. From the low risk group, all 101 subjects provided blood samples for analysis.||ug/mL||Standard Deviation|Mean
790559|NCT00876915|Secondary|The Value of Tissue Factor (TF) at Baseline Prior to Chemotherapy in Ambulatory Cancer Patients|Blood samples were obtained to measure the value of Tissue Factor at baseline compared between high risk for VTE and low risk for VTE ambulatory cancer patients.|baseline value of tissue factor|From 98 high risk patients, 89 provided blood samples used for this analysis. From the low risk group, all 101 subjects provided blood samples for analysis.||pg/mL||Standard Deviation|Mean
790560|NCT00876915|Primary|Percentage of Patients Who Experienced Clinically Significant Bleeding Events.|The percentage of patients who experienced a clinically significant bleeding event were recorded (including major and clinically significant non-major bleeding) over 13 weeks (12 weeks of study and an additional week of observation). Major bleeding was defined as being clinically overt and satisfying one of the following: decrease in hemoglobin of 2.0 g/dL, leading to transfusion of 2 or more units of blood or packed red cells, occurring in a critical site (intraocular, spinal/epidural, intracranial, retroperitoneal, or pericardial) or leading to death. Clinically significant non-major bleeding was defined as clinically overt, not meeting criteria for major bleeding and with one of the following characteristics: multiple-source, spontaneous hematoma > 25 cm², epistaxis > 5 mins, macroscopic hematuria not related to instrumentation, spontaneous rectal bleeding, gingival bleeding > 5 mins, hemoptysis, hematemesis or prolonged bleeding (> 5 minutes) after venipuncture.|13 weeks|||percentage of participants|||Number
790561|NCT00876915|Primary|Percentage of Patients With Venous Thromboembolisms|The percentage of patients who developed a Venous thromboembolism were recorded within 12 weeks following randomization including all adjudicated occurrences of symptomatic DVT, PE and upper extremity thrombus as well as all asymptomatic DVT and PE detected by lower extremity ultrasonography and chest CT.|12 weeks|||percentage of participants|||Number
790562|NCT00876928|Secondary|Disposition Index|Measure of insulin secretion multiplied by measure of insulin sensitivity,both derived from oral glucose tolerance test; higher values are better|Baseline, 3, 6, 9, 12 months|modified intent to treat||Unitless||Standard Deviation|Mean
790563|NCT00876928|Primary|Percent of Subjects Who Develop Diabetes|Diabetes defined by a FPG>=126 mg/dl or a 2-hr glucose concentration on an OGTT of >=200 mg/dl|one year|Minorities with pre-diabetes and hypovitaminosis D||percentage of participants|||Number
790564|NCT00877006|Secondary|Median Duration of Response at End of Follow-up||286 weeks (5.5 years)||07/2017||||
790565|NCT00877006|Secondary|Overall Survival at End of Follow-up||286 weeks (5.5 years)||07/2017||||
790566|NCT00877006|Secondary|Progression-free Survival and Event-free Survival at End of Follow-up||286 weeks (5.5 years)||07/2017||||
790567|NCT00877006|Secondary|Change From Baseline to End of Treatment in the Global Health Status Score of the European Organization for Research and Treatment of Cancer (EORTC) 30-item Core Quality of Life Questionnaire (QLQ-C30)|EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. EORTC QLQ-C30 includes functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and other (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). This outcome reports the global health status on a scale of 0-100 with a high score for the global health status/QOL represents a high quality of life.|Day 1 (prior to treatment), 32 weeks|The set of randomized participants (intent-to-treat) consisting of all patients randomly assigned to treatment, and who had data at both timepoints.||units on a scale||Standard Deviation|Mean
790568|NCT00877006|Secondary|Therapeutic Classification of Concomitant Medications||32 weeks|Safety Analysis Set: all participants randomly assigned to a treatment group who received 1 or more doses of any component of any study drug regimen.||participants|||Number
790569|NCT00877006|Secondary|Therapeutic Classification of Prior Medications||prior to start of treatment|Safety Analysis Set: all participants randomly assigned to a treatment group||participants|||Number
790570|NCT00877006|Secondary|Eastern Cooperative Oncology Group (ECOG) Performance Status at the End of Treatment Period|Participants' ECOG Performance Status was evaluated at the end of treatment as improved, stayed the same, or worsened from baseline (see Baseline Characteristics for ECOG Performance Status).|Week 32|Safety Analysis Set: all participants randomly assigned to a treatment group who received 1 or more doses of any component of any study drug regimen and with baseline and post-baseline values.||participants|||Number
790571|NCT00877006|Secondary|Potentially Clinically Significant Abnormal Weight|Participants were weighed at Baseline and at Endpoint (Week 32); those participants with an increase or decrease of >=10% were considered potentially clinically significant.|Baseline, Week 32|Safety Analysis Set: all participants randomly assigned to a treatment group who received 1 or more doses of any component of any study drug regimen with a baseline and post-baseline weight.||participants|||Number
790572|NCT00877006|Secondary|Clinically Significant Abnormal Vital Signs||32 weeks (conducted at screening, Day 1 of each cycle, and end-of-treatment visit)|Safety Analysis Set: all participants randomly assigned to a treatment group who received 1 or more doses of any component of any study drug regimen and had baseline and post-baseline values.||participants|||Number
790573|NCT00877006|Secondary|Worst Overall CTCAE Grade for Hematology Laboratory Test Results|Hematology test data were graded according to National Cancer Institute's (NCI) CTCAE version 3, and graded as 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening), 5 (death). The table presents the worst CTCAE grades for hematology test results experienced by participants overall (i.e., the worst post-baseline grade value for each participant and hematology test across all cycles).|32 weeks (conducted at screening, Day 1 of each cycle, weekly during treatment, and at the end-of-treatment visit)|Safety Analysis Set: all participants randomly assigned to a treatment group who received 1 or more doses of any component of any study drug regimen and who had an assessment.||participants|||Number
790574|NCT00877006|Secondary|Worst Overall Common Terminology Criteria for Adverse Events (CTCAE) Grades for Serum Chemistry Laboratory Test Results|Clinical laboratory data were graded according to National Cancer Institute's (NCI) CTCAE version 3, and graded as 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening), 5 (death). The table presents the worst CTCAE grades for serum chemistry test results experienced by participants overall (i.e., the worst post-baseline grade value for each participant and laboratory test across all cycles).|32 weeks (conducted at screening, Day 1 of each cycle, and end-of-treatment visit)|Safety Analysis Set: all participants randomly assigned to a treatment group who received 1 or more doses of any component of any study drug regimen and who had a post-baseline assessment.||participants|||Number
790575|NCT00877006|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations Due to AEs at End of Treatment Period|AE=any untoward medical occurrence that develops or worsens in severity after dispensation of the study drug and does not necessarily have a causal relationship to the study drug. An AE can, therefore, be any unfavorable and unintended physical sign, symptom, or laboratory parameter that develops or worsens in severity during the course of the study, or significant worsening of the disease under study (or any concurrent disease), whether or not considered related to the study drug. AEs were graded as 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening), 5 (death). SAE=an adverse event occurring at any dose that results in: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity (a substantial disruption of one’s ability to conduct normal life functions), a congenital anomaly/birth defect, or other important medical event.|32 weeks|Safety Analysis Set: all participants randomly assigned to a treatment group who received 1 or more doses of any component of any study drug regimen.||participants|||Number
790576|NCT00877006|Secondary|Percentage of Participants With Overall Response at End of Treatment Period|Overall Response=participants with Complete Remission (CR) + those with Partial Remission (PR). CR=see Outcome Measure 1 for details. PR= at least a 50% decrease in the sum of the product of the greatest diameters (SPD) of up to 6 of the largest dominant nodes/masses; at least a 50% decrease in the SPD of hepatic and splenic nodules in their greatest transverse diameter; no increase in the size of the liver, spleen, and other nodes; no measurable disease in organs other than the liver or spleen; no new sites of disease; protocol-specified PET scan and bone marrow criteria.|6 to 8 21 or 28-day cycles (18-32 weeks)|Evaluable Analysis Set: treated participants with a baseline and >=1 post-baseline response evaluation (based on computed tomography/magnetic resonance imaging [CT/MRI] or positron emission tomography [PET] and clinical data), or who discontinued treatment due to progressive disease and had no major protocol violations.||percentage of participants||95% Confidence Interval|Number
790577|NCT00877006|Primary|Percentage of Participants With Complete Response (CR) at End of Treatment Period|CR=complete disappearance of all detectable clinical evidence of disease and disease-related symptoms, if present pretherapy; protocol-specified positron emission tomography (PET) scan assessment criteria; (if the spleen and/or liver were enlarged on the basis of physical examination and/or anatomic imaging before treatment) the liver and/or spleen were considered normal size on physical examination and by anatomic imaging after therapy, with disappearance of all nodules related to lymphoma; (if the bone marrow was involved by lymphoma before treatment) the infiltrate must have cleared on subsequent bone marrow biopsies.|6 to 8 21 or 28-day cycles (18-32 weeks)|Evaluable Analysis Set: treated participants with a baseline and >=1 post-baseline response evaluation (based on computed tomography/magnetic resonance imaging [CT/MRI] or positron emission tomography [PET] and clinical data), or who discontinued treatment due to progressive disease and had no major protocol violations.||percentage of participants||95% Confidence Interval|Number
790578|NCT00877032|Secondary|Number of Participants With Anti-Drug Anti-body|Participants tested positive for anti-drug anti-body on at least one or more occasions were reported.|Baseline up to Day 168|Safety analysis population included all participants who received any amount of the single dose of either study drug or placebo.||participants|||Number
790579|NCT00877032|Secondary|Area Under the Curve From Time Zero to Day 165 [AUC (0-165d)] of Amyloid (A) Beta(1-X)|AUC (0-165d)= Area under the plasma concentration versus time curve from time zero (pre-dose) to Day 165.|Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 165|PD analysis population included all participants who received any amount of the single dose of either study drug or placebo.||nanogram*hr/mL (ng*hr/mL)||Standard Deviation|Mean
790580|NCT00877032|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Amyloid (A) Beta(1-X)||Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168|PD analysis population included all participants who received any amount of the single dose of either study drug or placebo.||hours||Full Range|Median
790626|NCT00877877|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Month 84 to Month 96|||Subjects|||Number
790581|NCT00877032|Secondary|Maximum Observed Plasma Concentration (Cmax) of Amyloid (A) Beta(1-X)||Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168|Pharmacodynamic (PD) analysis population included all participants who received any amount of the single dose of either study drug or placebo.||picogram/milliliter (pg/mL)||Standard Deviation|Mean
790582|NCT00877032|Secondary|Plasma Terminal Half-life (t1/2) of RN6G|Plasma terminal half-life is the time measured for the plasma concentration to decrease by one half. Participants who received RN6G were reported.|Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168|PK analysis population included all participants who received any amount of the single dose of RN6G. Here “N” (number of participants analyzed) signifies participants evaluable for this measure.||days||Standard Deviation|Mean
790583|NCT00877032|Secondary|Mean Residence Time (MRT) of RN6G|MRT was calculated as area under the moment curve from time 0 to extrapolated infinite time (AUMC[0 to inf])/area under the concentration effect curve from time 0 to extrapolated infinite time (AUC[0 to inf]). AUMC (0 to inf)= area under the moment curve from 0 to time t (AUMC 0-t) + [(Ct*tlast )/lamdaz ] + [Ct/(lamdaz )^2 ] where Ct= last measurable concentration, tlast= last measurable time, lamdaz= apparent terminal elimination rate constant. Participants who received RN6G were reported.|Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168|PK analysis population included all participants who received any amount of the single dose of RN6G. Here “N” (number of participants analyzed) signifies participants evaluable for this measure.||days||Standard Deviation|Mean
790584|NCT00877032|Secondary|Clearance (CL) of RN6G|CL is a quantitative measure of the rate at which a drug substance is removed from the body. Participants who received RN6G were reported and clearance was measured as mL/hr/kg of body weight.|Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168|PK analysis population included all participants who received any amount of the single dose of RN6G. Here “N” (number of participants analyzed) signifies participants evaluable for this measure.||mL/hr/kg||Standard Deviation|Mean
790585|NCT00877032|Secondary|Volume of Distribution (Vd) of RN6G|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Participants who received RN6G were reported and volume was measured as volume/kg of body weight.|Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168|PK analysis population included all participants who received any amount of the single dose of RN6G. Here “N” (number of participants analyzed) signifies participants evaluable for this measure.||mL/kilogram (mL/kg)||Standard Deviation|Mean
790586|NCT00877032|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of RN6G|Participants who received RN6G were reported.|Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168|PK analysis population included all participants who received any amount of the single dose of RN6G.||hours||Full Range|Median
790587|NCT00877032|Secondary|Maximum Observed Plasma Concentration (Cmax) of RN6G|Participants who received RN6G were reported.|Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168|PK analysis population included all participants who received any amount of the single dose of RN6G.||mcg/mL||Standard Deviation|Mean
790588|NCT00877032|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of RN6G|AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t). Participants who received RN6G were reported.|Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168|PK analysis population included all participants who received any amount of the single dose of RN6G.||mcg*hr/mL||Standard Deviation|Mean
790589|NCT00877032|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - Inf)] of RN6G|AUC (0 - inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf). Participants who received RN6G were reported.|Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168|Pharmacokinetic (PK) analysis population included all participants who received any amount of the single dose of RN6G. Here “N” (number of participants analyzed) signifies participants evaluable for this measure.||microgram*hour/milliliter (mcg*hr/mL)||Standard Deviation|Mean
790590|NCT00877032|Primary|Incidence and Severity of Systemic Adverse Events (AEs)|AE: untoward medical occurrence in participant who received study drug without regard to causal relationship. Systemic AEs was identified by spontaneous report or physical and neurological examinations changes in vital signs, clinical laboratory abnormalities, 12-lead electrocardiograms (ECG), brain magnetic resonance imaging (MRI). AE was assessed according to severity; mild (did not interfere with participant’s usual function), moderate (interfered to some extent with participant’s usual function) and severe (interfered significantly with participant’s usual function). Total number of participants with systemic (all AEs including eye-related) AEs and severity was reported.|Baseline up to Day 168|Safety analysis population included all participants who received any amount of the single dose of either study drug or placebo.||participants|||Number
790591|NCT00877032|Primary|Incidence and Severity of Ocular Adverse Events (AEs)|AE: untoward medical occurrence in participant who received study drug without regard to causal relationship. Ocular AE was identified by spontaneous report or ocular examination: early treatment diabetic retinopathy study (ETDRS) best-corrected visual acuity (BCVA); low-luminance BCVA; pupillary light response, extra-ocular muscle movements, external examination of the eyelids and eyelashes, slit-lamp biomicroscopic examination (SLE) of all components of the anterior and posterior segments, intra-ocular pressure (IOP), and dilated ocular fundus examination of the vitreous and retina. AE was assessed according to severity; mild (did not interfere with participant’s usual function), moderate (interfered to some extent with participant’s usual function) and severe (interfered significantly with participant’s usual function). Total number of participants with ocular (related to eye) AEs and severity was reported.|Baseline up to Day 168|Safety analysis population included all participants who received any amount of the single dose of either study drug or placebo.||participants|||Number
790593|NCT00877058|Primary|Number of Partipants Measured Frail at 1-year Follow up|Frailty defined as a sum of weakness, fatigue, weight loss, low physical activity, poor balance, slow gait speed, visual impairment and impaired cognition|1 year|ITT was used. The basic assumption was that older adults (80+) deteriorate over time in the natural course of the aging process. The imputation method chosen was to replace missing values with a value based on the Median Change of Deterioration (MCD) a conservative form of worst case between baseline and follow-up.||participants|||Number
790594|NCT00877058|Primary|Dependence in Two or More Activities of Daily Living (ADL)|"ADL stair case:
Independence of, or dependence on, another person in ADL was assessed according to a cumulative scale of well-defined personal and instrumental activities, the ADL staircase. Nine out of the ten original activities were used; Cleaning, shopping, transportation, cooking, bathing, dressing, going to the toilet, transfer, and feeding (0–9). Dependence was defined as another person being involved in the activity by giving personal or directive assistance. People living together were assessed as independent if they performed the activity when alone. The number of partipants with dependence in two or more ADL at follow-up have been analyzed"|1 year|||participants|||Number
790595|NCT00877071|Secondary|The Local Effects of the LC BeadTM in the Explanted Liver of Those Patients Who go on to Receive Liver Transplantation||36 months|The data was not analyzed due to insufficient enrollment. A total of 2 patients were enrolled during the course of the study. Both patients experienced disease progression; one patient following Treatment #1 and the other after Treatment #3.|||||
790596|NCT00877071|Secondary|Symptomatic and Quality-of-life Measures in Patients Treated With the LC BeadTM||36 months|The data was not analyzed due to insufficient enrollment. A total of 2 patients were enrolled during the course of the study. Both patients experienced disease progression; one patient following Treatment #1 and the other after Treatment #3.|||||
790597|NCT00877071|Secondary|The Objective Tumor Response Rate in Patients With HCC Treated With LC BeadTM Using EASL and RECIST Criteria||36 months|The data was not analyzed due to insufficient enrollment. A total of 2 patients were enrolled during the course of the study. Both patients experienced disease progression; one patient following Treatment #1 and the other after Treatment #3.|||||
790598|NCT00877071|Primary|The Number of Patients in the Cohort Effectively Downstaged to Transplant Eligibility With the LC BeadTM|Advanced HCC represents a high unmet medical need with a poor prognosis and few therapeutic options. Patients who present with HCC beyond the currently accepted Milan criteria are not eligible to be listed for liver transplantation. The proposed study offers local regional therapy to both a defined population of patients beyond Milan criteria as an attempt to downstage them to eligibility for liver transplant as well as those individuals within Milan criteria as an attempt to maintain their eligibility.|36 months|The data was not analyzed due to insufficient enrollment. A total of 2 patients were enrolled during the course of the study. Both patients experienced disease progression; one patient following Treatment #1 and the other after Treatment #3.|||||
790599|NCT00877370|Primary|Ertapenem Transmembrane Clearance by Continuous Hemodialysis.||24 hours after receiving first 1 gram dose|All participants were included in the analysis.||mL/min||Standard Deviation|Mean
790600|NCT00877383|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose at the End of the Study (Week 12, Day 84)|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, and 4 hours post-dose at the end of the study (Week 12, Day 84). The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|From 5 minutes to 4 hours post-dose at the end of the study (Week 12, Day 84)|Full analysis set (FAS): All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).||Liters||Standard Error|Least Squares Mean
790601|NCT00877383|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose on Day 1|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, and 4 hours post-dose on Day 1. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|From 5 minutes to 4 hours post-dose on Day 1|Full analysis set (FAS): All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).||Liters||Standard Error|Least Squares Mean
790602|NCT00877383|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose on Day 2|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose on Day 2. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|24 hours post-dose on Day 2|Full analysis set (FAS): All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).||Liters||Standard Error|Least Squares Mean
790603|NCT00877383|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 8 Hours Post-dose on Day 1|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, 4, 6, and 8 hours post-dose on Day 1. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|From 5 minutes to 8 hours post-dose on Day 1|Full analysis set (FAS): All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).||Liters||Standard Error|Least Squares Mean
790650|NCT00877890|Secondary|Percentage of Subjects Achieving Fasting Plasma Glucose Target of <=126 mg/dL|Percentages of subjects achieving fasting plasma glucose target of <=126 mg/dL at Week 24.|Week 24|ITT Population. Missing data up to Week 24 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. Subjects without post-baseline measurement were categorized as not achieving goal.||percentage of subjects|||Number
790604|NCT00877383|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of the Study (Week 12 + 1 Day, Day 85)|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of the study. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|End of the study (Week 12 + 1 day, Day 85)|Full analysis set (FAS): All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).||Liters||Standard Error|Least Squares Mean
790605|NCT00877383|Primary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 8 Hours Post-dose at the End of the Study (Week 12, Day 84)|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, 4, 6, and 8 hours post-dose at the end of the study (Week 12, Day 84). The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|From 5 minutes to 8 hours post-dose at the end of the study (Week 12, Day 84)|Full analysis set (FAS): All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).||Liters||Standard Error|Least Squares Mean
790606|NCT00877448|Primary|Treatment-related Adverse Events|Number of treatment-related adverse events per cohort|Day 0 until day 42 (termination visit)|||number of reported events|||Number
790607|NCT00877448|Primary|Adverse Events|Number of adverse events per cohort|day 0 until day 42 (termination visit)|||number of reported events|||Number
790608|NCT00877487|Primary|Percent of Treatment Failures at up to 6 Weeks|Treatment failure defined as > or equal to 50% increase in the ADHD-RS with adult prompts total score and a > or equal to 2 point increase in the CGI-S score.|Up to 6 weeks|Full Analysis Set (FAS) defined as all subjects who were randomized and received at least 1 dose of investigational product.||Percent of participants|||Number
790609|NCT00877487|Secondary|Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at up to 6 Weeks|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|Up to 6 weeks|FAS||Percent of Participants|||Number
790610|NCT00877487|Secondary|Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) With Adult Prompts Total Score at up to 6 Weeks|The ADHD-RS consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|Up to 6 weeks|FAS||Units on a scale||Standard Error|Least Squares Mean
790611|NCT00877604|Secondary|Medical Research Council Scores for Right and Left Muscle Groups||1 year||||||
790612|NCT00877604|Secondary|Incidence and Severity of Adverse Events, and Their Relationship to Treatment|laboratory tests, patients’ reports and the investigator’s judgments|1 year||||||
790613|NCT00877604|Secondary|ALSFRS-R at Study End||1 year||||||
790614|NCT00877604|Secondary|Survival Time From Starting of Study Medication Dosing (if Appropriate)||1 year||||||
790615|NCT00877604|Secondary|Time to Tracheostomy From Starting of Study Medication Dosing (if Appropriate)||1 year||||||
790616|NCT00877604|Secondary|SF-36 Quality of Life Rating Scale||1 year||||||
790617|NCT00877604|Secondary|Forced Vital Capacity (FVC) %||1 year||||||
790618|NCT00877604|Primary|The Proportion of Responder Patients in the Two Treatment Groups According the Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS)-R Slope.|Responder patients were defined as those subjects showing an improvement of at least 15% in the ALSFRS-R slope during the treatment period as compared to the lead-in period.|1 year|||participants|||Number
790619|NCT00877773|Primary|Tumor Response|For solid tumors, initial responses defined by Response Evaluation Criteria in Solid (RECIST) criteria in the evaluable lesion(s) per Complete Response (CR): Disappearance of all target lesions; confirmed at 4 weeks; Partial Response (PR): At least 30% decrease; confirmed at 4 weeks; Stable Disease (SD): Neither PR nor PD criteria met; Progressive Disease (PD): 20% increase; no CR, PR or SD documented before increased disease, or new lesion(s).|Baseline to Disease Progression (restaged at 8 weeks and at 4 months)|Of the 44 participants enrolled, only 30 were evaluable for response.||participants|||Number
790620|NCT00877799|Other Pre-specified|Total PCA Morphine Consumption in the 8-16 Hour Period Following Postoperative Study Drug Treatment||8 to 16 hours|Results are for Cohort 2 (study drug administered within 3 hours after surgery), ITT population, based on the number of evaluable patients over the 8-16 hour time interval.||mg||Standard Deviation|Mean
790621|NCT00877799|Other Pre-specified|Total PCA Morphine Consumption in the 4-8 Hour Period Following Postoperative Study Drug Treatment||4 to 8 hours|Results are for Cohort 2 (study drug administered within 3 hours after surgery), ITT population, based on the number of evaluable patients over the 4-8 hour time interval.||mg||Standard Deviation|Mean
790622|NCT00877799|Secondary|Total PCA Morphine Consumption in the 0-16 Hour Period Following Postoperative Study Drug Treatment||0 to 16 hours|Results are for Cohort 2 (study drug administered within 3 hours after surgery), ITT population.||mg||Standard Deviation|Mean
790623|NCT00877799|Primary|Responders on Pain Intensity(PI) and Pain Relief (PR) Composite Endpoint|The primary efficacy endpoint was the percentage of treatment responders compared to placebo. A responder was defined as a subject who had at least a 40% reduction in their pain intensity score and a pain relief score of “some,” “a lot,” or “complete” at 15 and 30 min following the start of the study drug infusion.|15 and 30 minutes after study drug administration|Results are for Cohort 2 (study drug administered within 3 hours after surgery), ITT population.||responders|||Number
790624|NCT00877877|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Month 108 to Month 120|||Subjects|||Number
790625|NCT00877877|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Month 96 to Month 108|||Subjects|||Number
790627|NCT00877877|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Month 72 to Month 84|Analysis was performed on the Month 84 Total Vaccinated cohort, which included all vaccinated subjects (who had received 3 doses during the primary study (NCT00196924)) for whom data were available for the Month 84 time point.||Subjects|||Number
790628|NCT00877877|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Month 60 to Month 72|Analysis was performed on the Month 72 Total Vaccinated cohort, which included all vaccinated subjects (who had received 3 doses during the primary study (NCT00196924)) for whom data were available for the Month 72 time point.||Subjects|||Number
790629|NCT00877877|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Month 48 to Month 60|The analysis was performed on the Month 60 Total Vaccinated cohort, which included all vaccinated subjects (who had received 3 doses during the primary study (NCT00196924)) for whom data were available for the Month 60 time point.||Subjects|||Number
790630|NCT00877877|Primary|Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.|Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. A seronegative subject is a subject with antibody titer < 8 or 7 EL.U/mL prior to vaccination. A seropositive subject is a subject with antibody titer >= 8 or 7 EL.U/mL prior to vaccination.|At Month 120|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 120 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 120 blood sampling timepoint.||Subjects|||Number
790631|NCT00877877|Primary|Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers|Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. A seronegative subject is a subject with antibody titer < 8 or 7 EL.U/mL prior to vaccination. A seropositive subject is a subject with antibody titer >= 8 or 7 EL.U/mL prior to vaccination.|At Month 120|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 120 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 120 blood sampling timepoint.||EL.U/mL||95% Confidence Interval|Geometric Mean
790632|NCT00877877|Primary|Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers|Anti-HPV-16 and 18 antibody titers are given in Geometric Mean Titers (GMTs) in Enzyme-linked Immunosorbent Assay (ELISA) Units per milliliter (EL.U/mL).|At Month 108|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 108 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 108 blood sampling timepoint.||EL.U/ML||95% Confidence Interval|Geometric Mean
790633|NCT00877877|Primary|Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.|Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. A seronegative subject is a subject with antibody titer < 8 or 7 EL.U/mL prior to vaccination. A seropositive subject is a subject with antibody titer >= 8 or 7 EL.U/mL prior to vaccination.|At Month 108|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 108 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 108 blood sampling timepoint.||Subjects|||Number
790634|NCT00877877|Primary|Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers|Anti-HPV-16 and 18 antibody titers are given in Geometric Mean Titers (GMTs) in Enzyme-linked Immunosorbent Assay (ELISA) Units per milliliter (EL.U/mL).|At Month 96|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 96 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 96 blood sampling timepoint.||EL.U/mL||95% Confidence Interval|Geometric Mean
790635|NCT00877877|Primary|Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers|Anti-HPV-16 and 18 antibody titers are given in Geometric Mean Titers (GMTs) in Enzyme-linked Immunosorbent Assay (ELISA) Units per milliliter (EL.U/mL).|At Month 84|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 84 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 84 blood sampling timepoint.||EL.U/mL||95% Confidence Interval|Geometric Mean
790636|NCT00877877|Primary|Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers|Anti-HPV-16 and 18 antibody titers are given in Geometric Mean Titers (GMTs) in Enzyme-linked Immunosorbent Assay (ELISA) Units per milliliter (EL.U/mL).|At month 72|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 72 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 72 blood sampling timepoint.||EL.U/mL||95% Confidence Interval|Geometric Mean
790637|NCT00877877|Primary|Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers|Anti-HPV-16 and 18 antibody titers are given in Geometric Mean Titers (GMTs) in Enzyme-linked Immunosorbent Assay (ELISA) Units per milliliter (EL.U/mL).|At Month 60|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 60 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 60 blood sampling timepoint.||EL.U/mL||95% Confidence Interval|Geometric Mean
790686|NCT00877929|Secondary|BP Control (SBP<140 mmHg, DBP<90 mmHg) at One Week|Mean seated SBP<140 mmHg and mean seated DBP<90 mmHg|Baseline, week 1|Treated set using LOCF||participants|||Number
790638|NCT00877877|Primary|Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.|"Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL.
Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.
A seronegative subject is a subject with antibody titer < 8 or 7 EL.U/mL prior to vaccination.
A seropositive subject is a subject with antibody titer >= 8 or 7 EL.U/mL prior to vaccination."|At Month 96|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 96 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 96 blood sampling timepoint.||Subjects|||Number
790639|NCT00877877|Primary|Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.|"Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL.
Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.
A seronegative subject is a subject with antibody titer < 8 or 7 EL.U/mL prior to vaccination.
A seropositive subject is a subject with antibody titer >= 8 or 7 EL.U/mL prior to vaccination."|At Month 84|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 84 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 84 blood sampling timepoint.||Subjects|||Number
790640|NCT00877877|Primary|Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.|"Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL.
Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.
A seronegative subject is a subject with antibody titer < 8 or 7 EL.U/mL prior to vaccination.
A seropositive subject is a subject with antibody titer >= 8 or 7 EL.U/mL prior to vaccination."|At Month 72|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 72 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 72 blood sampling timepoint.||Subjects|||Number
790641|NCT00877877|Primary|Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.|"Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL.
Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.
A seronegative subject is a subject with antibody titer < 8 or 7 EL.U/mL prior to vaccination.
A seropositive subject is a subject with antibody titer >= 8 or 7 EL.U/mL prior to vaccination."|At Month 60|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 60 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 60 blood sampling timepoint.||Subjects|||Number
790642|NCT00877890|Secondary|Assessment on Event Rate of Treatment-emergent Minor Hypoglycemic Events|The minor hypoglycemia category included events in which symptoms consistent with hypoglycemia were accompanied by a blood glucose concentration of less than 54 mg/dL prior to treatment and not classified as major hypoglycemia.|Day 1 to Week 24|ITT Population. Analysis was done for SU ITT patients (ITT patients taking SU) and Non-SU ITT patients separately.||rate per subject-year||Standard Error|Mean
790643|NCT00877890|Secondary|Assessment on Event Rate of Treatment-emergent Major Hypoglycemic Events|The major hypoglycemia category included events that, in the judgment of the investigator or physician, resulted in loss of consciousness, seizure, coma, or other change in mental status consistent with neuroglycopenia, in which symptoms resolved after administration of intramuscular glucagon or intravenous glucose, required third-party assistance, and was accompanied by a blood glucose concentration of less than 54 mg/dL prior to treatment, whether or not symptoms of hypoglycemia were perceived by the subject.|Day 1 to Week 24|ITT Population. Analysis was done for SU ITT patients (ITT patients taking SU) and Non-SU ITT patients separately.||rate per subject-year||Standard Error|Mean
790644|NCT00877890|Secondary|Ratio of Triglycerides at Week 24 to Baseline|Ratio of triglycerides (measured in mg/dL) at Week 24 to baseline (Day 1). Log (Postbaseline Triglycerides) - log (Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline.|Day 1, Week 24|ITT Population. Missing data up to Week 24 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.||ratio||Standard Error|Least Squares Mean
790645|NCT00877890|Secondary|Change in High-density Lipoprotein (HDL) From Baseline to Week 24|Change in HDL from baseline (Day 1) to Week 24.|Day 1, Week 24|ITT Population. Missing data up to Week 24 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.||mg/dL||Standard Error|Least Squares Mean
790646|NCT00877890|Secondary|Change in Total Cholesterol From Baseline to Week 24|Change in total cholesterol from baseline (Day 1) to Week 24.|Day 1, Week 24|ITT Population. Missing data up to Week 24 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.||mg/dL||Standard Error|Least Squares Mean
790647|NCT00877890|Secondary|Change in Sitting Diastolic Blood Pressure From Baseline to Week 24|Change in diastolic blood pressure from baseline (Day 1) to Week 24.|Day 1, Week 24|ITT Population. Missing data up to Week 24 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.||mmHg||Standard Error|Least Squares Mean
790648|NCT00877890|Secondary|Change in Sitting Systolic Blood Pressure From Baseline to Week 24|Change in systolic blood pressure from baseline (Day 1) to Week 24.|Day 1, Week 24|ITT Population. Missing data up to Week 24 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.||mmHg||Standard Error|Least Squares Mean
790649|NCT00877890|Secondary|Change in Body Weight From Baseline to Week 24|Change in body weight from baseline (Day 1) to Week 24.|Day 1, Week 24|ITT Population. Missing data up to Week 24 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.||kg||Standard Error|Least Squares Mean
790651|NCT00877890|Secondary|Change in Fasting Plasma Glucose From Baseline to Week 24|Change in fasting plasma glucose from baseline (Day 1) to Week 24.|Day 1, Week 24|ITT Population. Missing data up to Week 24 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.||mg/dL||Standard Error|Least Squares Mean
790652|NCT00877890|Secondary|Percentage of Subjects Achieving HbA1c Target of <=6.5%|Percentages of subjects achieving HbA1c target values of <=6.5% at Week 24.|Week 24|ITT Population. Missing data up to Week 24 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. Subjects without post-baseline measurement were categorized as not achieving goal.||percentage of subjects|||Number
790653|NCT00877890|Secondary|Percentage of Subjects Achieving HbA1c Target of <7%|Percentages of subjects achieving HbA1c target value of <7% at Week 24.|Week 24|ITT Population. Missing data up to Week 24 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. Subjects without post-baseline measurement were categorized as not achieving goal.||percentage of subjects|||Number
790654|NCT00877890|Primary|Change in HbA1c From Baseline to Week 24|Change in HbA1c from baseline (Day 1) to Week 24 [Week 24 - Baseline].|Day 1, Week 24|The ITT Population consisted of all randomized subjects who received at least one injection of study medication. Missing data up to Week 24 were imputed using the last observation carried forward (LOCF) approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.||percentage of total hemoglobin||Standard Error|Least Squares Mean
790655|NCT00877929|Secondary|Change From Baseline in Urine Albumin:Creatinine Ratio (UACR)|Change from baseline in UACR (measured in spot urine) after eight weeks of treatment|8 weeks|Treated set||ratio||Standard Deviation|Mean
790656|NCT00877929|Secondary|DBP Response at Week One|Mean seated DBP <80 mmHg or a reduction of >=10 mmHg|Week 1|Treated set||participants|||Number
790657|NCT00877929|Secondary|DBP Response at Week Two|Mean seated DBP <80 mmHg or a reduction of >=10 mmHg|Week 2|Treated set||participants|||Number
790658|NCT00877929|Secondary|DBP Response at Week Four|Mean seated DBP <80 mmHg or a reduction of >=10 mmHg|Week 4|Treated set||participants|||Number
790659|NCT00877929|Secondary|DBP Response at Six Weeks|Mean seated DBP<80 mmHg or a reduction of <=10 mmHg|week 6|Treated set||participants|||Number
790660|NCT00877929|Secondary|DBP Response at Eight Weeks|Mean seated DBP<80 mmHg or a reduction of <=10 mmHg|Week 8|Treated set||participants|||Number
790661|NCT00877929|Secondary|SBP Response 130 at One Week|SBP <130 mmHg or a reduction >=10 mmHg|Baseline, week 1|Treated set using LOCF||participants|||Number
790662|NCT00877929|Secondary|SBP Response 130 at Two Weeks|SBP <130 mmHg or a reduction >=10 mmHg|Baseline, week 2|Treated set using LOCF||participants|||Number
790663|NCT00877929|Secondary|SBP Response 130 at Four Weeks|SBP <130 mmHg or a reduction >=10 mmHg|Baseline, week 4|Treated set using LOCF||participants|||Number
790664|NCT00877929|Secondary|SBP Response 130 at Six Weeks|SBP <130 mmHg or a reduction >=10 mmHg|Baseline, week 6|Treated set using LOCF||participants|||Number
790665|NCT00877929|Secondary|SBP Response 130 at Eight Weeks|SBP <130 mmHg or a reduction >=10 mmHg|Baseline, week 8|Treated set using LOCF||participants|||Number
790666|NCT00877929|Secondary|SBP Response 140 at One Week|SBP <140 mmHg or a reduction >=10 mmHg|Baseline, week 1|Treated set using LOCF||participants|||Number
790667|NCT00877929|Secondary|SBP Response 140 at Two Weeks|SBP <140 mmHg or a reduction >=10 mmHg|Baseline, week 2|Treated set using LOCF||participants|||Number
790668|NCT00877929|Secondary|SBP Response 140 at Four Weeks|SBP <140 mmHg or a reduction >=10 mmHg|Baseline, week 4|Treated set using LOCF||participants|||Number
790669|NCT00877929|Secondary|SBP Response 140 at Six Weeks|SBP <140 mmHg or a reduction >=10 mmHg|Baseline, week 6|Treated set using LOCF||participants|||Number
790670|NCT00877929|Secondary|SBP Response 140 at Eight Weeks|SBP < 140 mmHg or a reduction >=10 mmHg|Baseline, week 8|Treated set using LOCF||participants|||Number
790671|NCT00877929|Secondary|SBP Control 130 at One Week|Mean seated SBP < 130 mmHg|Baseline, week 1|Treated set using LOCF||participants|||Number
790672|NCT00877929|Secondary|SBP Control 130 at Two Weeks|Mean seated SBP < 130 mmHg|Baseline, week 2|Treated set using LOCF||participants|||Number
790673|NCT00877929|Secondary|SBP Control 130 at Four Weeks|Mean seated SBP < 130 mmHg|Baseline, week 4|Treated set using LOCF||participants|||Number
790674|NCT00877929|Secondary|SBP Control 130 at Six Weeks|Mean seated SBP < 130 mmHg|Baseline, week 6|Treated set using LOCF||participants|||Number
790675|NCT00877929|Secondary|SBP Control 130 at Eight Weeks|Mean seated SBP < 130 mmHg|Baseline, week 8|Treated set using LOCF||participants|||Number
790676|NCT00877929|Secondary|SBP Control 140 at One Week|Mean seated SBP < 140 mmHg|Baseline, week 1|Treated set using LOCF||participants|||Number
790677|NCT00877929|Secondary|SBP Control 140 at Two Weeks|Mean seated SBP < 140 mmHg|Baseline, week 2|Treated set using LOCF||participants|||Number
790678|NCT00877929|Secondary|SBP Control 140 at Four Weeks|Mean seated SBP < 140 mmHg|Baseline, week 4|Treated set using LOCF||participants|||Number
790679|NCT00877929|Secondary|SBP Control 140 at Six Weeks|Mean seated SBP < 140 mmHg|Baseline, week 6|Treated set using LOCF||participants|||Number
790680|NCT00877929|Secondary|Systolic Blood Pressure (SBP) Control 140 at Eight Weeks|Mean seated SBP < 140 mmHg|Baseline, week 8|Treated set using LOCF||participants|||Number
790681|NCT00877929|Secondary|BP Control (SBP<130 mmHg, DBP<80 mmHg) at One Week|Mean seated SBP<130 mmHg and mean seated DBP<80 mmHg|Baseline, week 1|Treated set using LOCF||participants|||Number
790682|NCT00877929|Secondary|BP Control (SBP<130 mmHg, DBP<80 mmHg) at Two Weeks|Mean seated SBP<130 mmHg and mean seated DBP<80 mmHg|Baseline, week 2|Treated set using LOCF||participants|||Number
790683|NCT00877929|Secondary|BP Control (SBP<130 mmHg, DBP<80 mmHg) at Four Weeks|Mean seated SBP<130 mmHg and mean seated DBP<80 mmHg|Baseline, week 4|Treated set using LOCF||participants|||Number
790684|NCT00877929|Secondary|BP Control (SBP<130 mmHg, DBP<80 mmHg) at Six Weeks|Mean seated SBP<130 mmHg and mean seated DBP<80 mmHg|Baseline, week 6|Treated set using LOCF||participants|||Number
790685|NCT00877929|Secondary|BP Control (SBP<130 mmHg, DBP<80 mmHg) at Eight Weeks|Mean seated SBP<130 mmHg and mean seated DBP<80 mmHg|Baseline, week 8|Treated set using LOCF||participants|||Number
790694|NCT00877929|Secondary|Change From Baseline in Trough Seated Systolic Blood Pressure to Week 6|Trough blood pressure measurements were the measurements observed at the end of the dosing interval just prior to the next dose of medication.|Baseline, week 6|||mmHg||Standard Error|Least Squares Mean
790695|NCT00877929|Primary|Change From Baseline in Trough Seated Systolic Blood Pressure to Week 8|Trough blood pressure measurements were the measurements observed at the end of the dosing interval just prior to the next dose of medication.|Baseline, week 8|Treated Set includes all randomized participants who took at least one dose of treatment||mmHg||Standard Error|Least Squares Mean
790696|NCT00870363|Secondary|Immune Reconstitution With Respect to Absolute Numbers of CD4+ T-cells, the Relative Proportion of T-cell Subpopulations in the Tissue, and Immune Activation to a Cohort of Normal Controls||nine months|data was not collected/analyzed due to complications in the assays for immune activation in the collected samples|||||
790697|NCT00870363|Secondary|Changes in CD4+ T-cell Numbers by Treatment Regimen|peripheral absolute CD4+ T-cell counts increase from baseline to 9 months of cART by commercial assay|Baseline and nine months|peripheral CD4 T-cell counts were not measured in the HIV negative cohort||cells/mL||95% Confidence Interval|Mean
790698|NCT00870363|Secondary|Lymphocyte Immune Function and Activation at Two Time Points Approximately Nine Months Apart in GALT; and Four Timepoints (Month 0, 3, 6, and 9) in Peripheral Blood||nine months|data were not collected due to inadequate sample volume for this complex experiment design|||||
790699|NCT00870363|Secondary|Change in GALT CD4+ and CD8+ T-cell Subpopulations (naïve and Memory Subsets)||nine months|data were not collected due to the samples not being suitable for the epitopes being measured|||||
790700|NCT00870363|Secondary|Change in HIV DNA Per 10^6 Cells in Duodenal Tissue Versus PBMC by Drug Regimen Received|single-cell suspension of digested duodenal tissue and Ficol-Hypaque separated PBMC underwent HIV-DNA PCR|Baseline and nine months|HIV negative controls did not have HIV-DNA in blood or tissue||copies/10^6 cells||95% Confidence Interval|Mean
790701|NCT00870363|Secondary|Trough Plasma and Tissue Drug Levels in Volunteers at the Time of the Upper Endoscopy|The reported drug level is for the primary ART agent for that cohort. For the maraviroc arm, maraviroc plasma and tissue levels are reported. For the maraviroc plus raltegravir arm, the raltegravir plasma and tissue levels are reported. For the efavirenz arm, the efavirenz plasma and tissue levels are reported. HIV negative controls were not on ART and did not have drug levels measured.|nine months|HIV negative controls were not on ART and did not have drug levels measured.||ng/mL||Inter-Quartile Range|Median
790702|NCT00870363|Primary|Change in the Density of CD3+/CD4+ Cells Per Cubic Millimeter at the Effector Sites in the Duodenal Tissues Following Antiretroviral Therapy Regimen|immunohistochemistry for CD3+/CD4+ cells counted manually within the lamina propria|Baseline and nine months for 3 treatment cohorts and Baseline for the control group, which was only assessed at one time point|numbers represent an increase from baseline for the 3 treatment cohorts and represent the absolute value for the control group who were only measured at one timepjoint.||cells/mm^2||95% Confidence Interval|Mean
790703|NCT00878228|Secondary|Impact of Nausea and Vomiting on Quality of Life|Percentage of participants whose quality of life was impacted by nausea and vomiting|Postdischarge Day 1|||percentage of participants|||Number
790704|NCT00878228|Secondary|Severity of Nausea|Percentage of participants reporting moderate or severe nausea in the first 24 hours|Postdischarge Day 1|||percentage of participants|||Number
790705|NCT00878228|Primary|Incidence of Nausea|Percentage of participants with nausea|Postdischarge Day 1|||percentage of participants|||Number
790706|NCT00881959|Primary|Non –Inferiority of Dermis to Alloderm|Non –inferiority of Dermis to Alloderm will be assessed by comparison of the average change (from the preoperative value) in gingival recession measured at 12 months between defects receiving Puros Dermis and those receiving Alloderm.|12 months|||mm||Standard Deviation|Mean
790707|NCT00882102|Primary|Number of Participants With a Complete Response|Complete Response (CR) was defined as normalization of peripheral blood and bone marrow with </= 5% blasts, a peripheral absolute neutrophil count (ANC) >/= 1 * 10^9 /l, and a platelet count of >/= 100 & 10^9 /l. Approximately Day 14 of the first cycle of 4 - 8 week cycle, a bone marrow aspirate was performed to check the status of the disease using International Working Group (IWG) criteria for acute myelogenous leukemia (AML) and myelofibrosis (MF).|Day 14 of first cycle|||Participants|||Number
790708|NCT00882206|Secondary|Level of Methylation|the percentage of methylated DNA|Day 33|The following participants were removed from the analysis: two patients had an early death; one patient had early disease progression; one patient was found to have nervous system involvement on day 5 of therapy; and one patient stopped study therapy due to toxicities.||percentage of DNA||Standard Deviation|Mean
790709|NCT00882206|Secondary|Level of Methylation|the percentage of methylated DNA|Day 5|The following participants were removed from the analysis: two patients had an early death; one patient had early disease progression; one patient was found to have nervous system involvement on day 5 of therapy; and one patient stopped study therapy due to toxicities.||percentage of DNA||Standard Deviation|Mean
790710|NCT00882206|Secondary|Level of Methylation|the percentage of methylated DNA|Day 0|||percentage of DNA||Standard Deviation|Mean
790711|NCT00882206|Primary|Response to Treatment|Response includes both complete remission (defined as <5% leukemic blasts in the bone marrow) and partial remission (defined as a greater than 35% reduction in the bone marrow leukemia blast percentage at day 33)|Day 33|The following participants were removed from the analysis: two patients had an early death; one patient had early disease progression; one patient was found to have nervous system involvement on day 5 of therapy; and one patient stopped study therapy due to toxicities.||participants|||Number
790712|NCT00882310|Secondary|Score on FACT-Hep (Version 4)|"Quality of life score of patients treated with the adjuvant GTX regimen using, the FACT-Hep (Version 4), a sensitive measure of quality of life.
Data was not analyzed because original PI left institution before data analysis was completed."|Prior to starting treatment, after 3 months of treatment, and at the end of study visit.||||||
790713|NCT00882310|Secondary|Time to Death|"Median recurrence free survival in patients with non-metastatic, resected pancreatic cancer treated with adjuvant GTX.
Data was not analyzed because original PI left institution before data analysis was completed."|At 6 months (following completion of treatment), and then every 3 months for the first 2 years. After the first 2 year, annually.||||||
790714|NCT00882310|Primary|Number of Subjects Who Experience Dose Limiting Toxicities (DLTs)|"Safety of the GTX regimen in patients with resected pancreatic cancer, using the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.
Data was not analyzed because original PI left institution before data analysis was completed."|At days 4, 11, and follow-up.||||||
790715|NCT00882362|Primary|Montgomery–Asberg Depression Rating Scale (MADRS)|"Change from baseline to Last Observation Carried Forward (LOCF).
Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.
The questionnaire includes questions on the following symptoms
1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts"|Baseline(Day 1), Week52 or at discontinuation|||Rating Score||Standard Error|Mean
790716|NCT00882440|Secondary|Mean Change From Baseline in Peak Supine Diastolic Blood Pressure (SuDBP) at Week 8||6 hours post dose at Baseline and 8 weeks|"An all patients treated approach was employed that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available."||mm Hg||Standard Deviation|Mean
790717|NCT00882440|Primary|Mean Change From Baseline in Trough Supine Diastolic Blood Pressure (SuDBP) at Week 8||24 hours post dose at Baseline and Week 8|"The primary analysis employed an all patients treated approach that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available."||mm Hg||Standard Deviation|Mean
790718|NCT00882440|Secondary|Categories of Antihypertensive Response in Trough Supine Diastolic Blood Pressure (SuDBP) at Week 8|"Patients in Category I (defined as excellent in protocol) if SuDBP was <90 mmHg, Category II (defined as good in protocol) if SuDBP was ≥90 but decreased at least 10 mmHg, or Category III (defined as fair or inadequate in protocol) if SuDBP was ≥90 and decreased less than 10 mmHg."|24 hours post dose at Week 8|"An all patients treated approach was employed that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available."||Participants|||Number
790719|NCT00882518|Secondary|Change in the CGI Severity of Illness Score From Baseline at the End of Treatment at Day 42|6 weeks minus baseline The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale rating the severity of the patient's illness. The patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.|Baseline and 6 weeks|Full analysis set was used for secondary outcome||scores on a scale||Standard Error|Least Squares Mean
790720|NCT00882518|Secondary|Percentage of Patients With Clinical Global Impression (CGI) Global Improvement Rating Less Than or Equal to 3 at the End of Treatment at Day 42|"6 weeks minus baseline. The number of patients with CGI Global Improvement (CGI-I) rating at least “minimally improved” at the end of treatment at Day 42 was counted, and then got the proportion among all the patients.CGI-I is scored to rate the patient’s change from baseline CGI on a seven-point scale (1=”Very much improved”, 7=”Very much worse.)"|Baseline and 6 weeks|Full analysis set was used for secondary outcome||percentage of participants|||Number
790721|NCT00882518|Secondary|Number of Patients Achieving a Reduction of at Least 30% From Baseline PANSS Total Score at the End of Treatment at Day 42|"6 weeks minus baseline PANSS scale is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7 (better to worse).Total scores range 30-210 from better to worse.
1 =Absent,2 =Minimal, 3 =Mild, 4 =Moderate, 5 =Moderate severe, 6 =Severe, 7= Extreme."|Baseline and 6 weeks|Full analysis set was used for secondary outcome||Percentage of participants|||Number
790722|NCT00882518|Secondary|Change From Baseline in PANSS Depression Clusters Score at the End of Treatment at Day 42|"6 weeks minus baseline PANSS scale is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7 (better to worse).
1 =Absent ,2 =Minimal, 3 =Mild, 4 =Moderate, 5 =Moderate severe, 6 =Severe, 7= Extreme"|Baseline and 6 weeks|Full analysis set was used for secondary outcome||scores on a scale||Standard Error|Least Squares Mean
790723|NCT00882518|Secondary|Change From Baseline in PANSS Aggression, Hostility Clusters Score at the End of Treatment at Day 42|"6 weeks minus baseline PANSS scale is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7 (better to worse).
1 =Absent ,2 =Minimal, 3 =Mild, 4 =Moderate, 5 =Moderate severe, 6 =Severe, 7= Extreme"|Baseline and 6 weeks|Full analysis set was used for secondary outcome||scores on a scale||Standard Error|Least Squares Mean
790724|NCT00882518|Secondary|Change From Baseline in PANSS General Psychopathological Subscale Score at the End of Treatment at Day 42|The PANSS psychopathological subscale score is the sum of 16 item scores(somatic concern, anxiety, guilt feelings, tension, mannerisms and posturing, depression, motor retardation, uncooperativeness, unusual thought content, disorientation, poor attention, lack of judgment and insight, disturbance of volition, poor impulse control, preoccupation, active social avoidance), ranges from 16 to 112. A negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Baseline and 6 weeks|Full analysis set was used for secondary outcome||scores on a scale||Standard Error|Least Squares Mean
790725|NCT00882518|Secondary|Change From Baseline in PANSS Negative Subscale Score at the End of Treatment at Day 42|6 weeks minus baseline PANSS scale is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7. 1 =Absent ,2 =Minimal, 3 =Mild, 4 =Moderate, 5 =Moderate severe, 6 =Severe, 7= Extreme The PANSS negative subscale score is the sum of the 7 item scores (blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking), ranges from 7 to 49. A negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Baseline and 6 weeks|Full analysis set was used for secondary outcome||scores on a scale||Standard Error|Least Squares Mean
790743|NCT00882661|Secondary|Neck Disability Index (NDI)|Neck Disability Index (NDI) success defined as ≥25% improvement at 24 months from baseline|24 months|At the time of database lock, of the 380 patients enrolled in the PMA study, all had reached the 24 month post-operative visit. Complete Neck Disability Index (NDI) data was available for 78 Non-randomized SECURE-C patients,139 randomized SECURE-C patients and 116 control patients at 24 months.||participants|||Number
790726|NCT00882518|Secondary|Change From Baseline in PANSS Positive Subscale Score at the End of Treatment at Day 42|6 weeks minus baseline PANSS scale is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7. 1 =Absent ,2 =Minimal, 3 =Mild, 4 =Moderate, 5 =Moderate severe, 6 =Severe, 7= Extreme The PANSS positive subscale score is the sum of the 7 positive item scores (ie, delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution and hostility) and ranges from 7 to 49. A negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Baseline and 6 weeks|Full analysis set was used for secondary outcome||scores on a scale||Standard Error|Least Squares Mean
790727|NCT00882518|Primary|Change From Baseline of the Positive and Negative Syndrome Scale (PANSS) Total Score at the End of Treatment at Day 42|6 weeks minus baseline.PANSS scale is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7. Total scores range 30-210 from better to worse.|Baseline and 6 weeks|Per-protocol population was used as the analysis set for primary outcome, because this is a non-inferior design study.||scores on a scale||Standard Error|Least Squares Mean
790735|NCT00882583|Primary|1.Maximally Tolerated Dose (MTD) of Daily Oral Dasatinib in Combination With Cetuximab/RT in Cohort A 2. MTD of Daily Oral Dasatinib in Combination With Cisplatin/Cetuximab/RT in Cohort B|The MTD for Dasatinib was defined as a) the dose producing DLT ( Dose limiting toxicity) in 0-1 out of 6 patients, or b) the dose level below the dose which produced DLT in <2 out of 6 patients, or c) the dose of 150mg PO QD with less than 33% rate of DLT.|Last day of Radiation|MTD not reached. Study closed to slow accrual.||participants|||Number
790736|NCT00882583|Primary|Phase I is Efficacy and Safety. Phase II Will be Tumor Response||Phase I will enroll over 12-18 months||||||
790737|NCT00882661|Secondary|Satisfaction|Patient satisfaction (definitely/mostly): proportion of patients|24 months|At the time of database lock, of the 380 patients enrolled in the PMA study, all had reached the 24 month post-operative visit. Complete Patient Satisfaction data was available for 78 non-randomized SECURE-C patients, 139 randomized SECURE-C patients and 115 control patients at 24 months.||participants|||Number
790738|NCT00882661|Secondary|SF-36 MCS|Health Status Survey SF-36 mental composite scores: 15% improvement from baseline|24 months|At the time of database lock, of the 380 patients enrolled in the PMA study, all had reached the 24 month post-operative visit. Complete SF-36 MCS data was available for 78 non-randomized SECURE-C patients, 138 randomized SECURE-C patients and 114 control patients at 24 months.||participants|||Number
790739|NCT00882661|Secondary|SF-36 PCS|Health Status Survey SF-36 physical composite scores: 15% improvement from baseline|24 months|At the time of database lock, of the 380 patients enrolled in the PMA study, all had reached the 24 month post-operative visit. Complete SF-36 PCS data was available for 78 non-randomized SECURE-C patients, 138 randomized SECURE-C patients and 114 control patients at 24 months.||participants|||Number
790740|NCT00882661|Secondary|Right Arm Pain Visual Analog Scale (VAS)|Improvement of 20mm from baseline in right arm pain measured using the Visual Analog Scale (VAS)|24 months|At the time of database lock, of the 380 patients enrolled in the PMA study, all had reached the 24 month post-operative visit. Complete Right Arm Pain Visual Analog Scale (VAS) data was available for 75 non-randomized SECURE-C patients, 133 randomized SECURE-C patients and 108 control patients at 24 months.||participants|||Number
790741|NCT00882661|Secondary|Left Arm Pain Visual Analog Scale (VAS)|Improvement of 20mm from baseline in left arm pain measured using the Visual Analog Scale (VAS)|24 months|At the time of database lock, of the 380 patients enrolled in the PMA study, all had reached the 24 month post-operative visit. Complete Left Arm Pain Visual Analog Scale (VAS) data was available for 75 non-randomized SECURE-C, 133 randomized SECURE-C patients and 108 control patients at 24 months.||participants|||Number
790742|NCT00882661|Secondary|Neck Pain Visual Analog Scale (VAS)|Improvement of 20mm from baseline in neck pain measured using the Visual Analog Scale (VAS)|24 months|At the time of database lock, of the 380 patients enrolled in the PMA study, all had reached the 24 month post-operative visit. Complete Neck Pain Visual Analog Scale (VAS) data was available for 75 non-randomized SECURE-C, 133 randomized SECURE-C patients and 108 control patients at 24 months.||participants|||Number
790744|NCT00882661|Primary|Individual Patient Overall Success|Individual patient overall success defined as pain/disability improvement of at least 25% in Neck Disability Index (NDI) compared to baseline; no device failures requiring revision, removal, reoperation, or supplemental fixation; absence of major complications defined as major vessel injury, neurological damage, or nerve injury; and for control fusion patients only, radiographic fusion|24 months|At the time of database lock, of the 380 patients enrolled in the PMA study, all had reached the 24 month post-operative visit. Complete primary endpoint data was available for 79 Non-randomized SECURE-C patients,141 randomized SECURE-C patients and 114 control patients at 24 months.||participants|||Number
790745|NCT00882687|Secondary|Conjunctival Redness at Day 6 (CAC 4), 5 (CAC 7)|Conjunctival Redness was evaluated by an investigator with slit lamp and graded with ORA Scale with the score ranged from 0 to 4 (0=none; 1=mild-slightly dilated blood vessels; color of vessels is typically pink; can be quadrantal; 2=moderate-more apparent dilation of blood vessels; vessel color is more intense (redder); involves the majority of the vessel bed; 3=severe-numerous and obvious dilated blood vessels; in the absence of chemosis the color is deep red, may be less red or pink in presence of chemosis, is not quadrantic; 4=extremely severe-large, numerous, dilated blood vessels characterized by unusually severe deep red color, regardless of grade of chemosis, which involves the entire vessel bed) with 0.5 point increments allowed, and lower scores indicates reduction in the conjunctival redness.|Baseline to Day 6 (CAC 4), Day 13 (CAC 7) at 20 minutes post CAC|ITT population with LOCF||units on a scale||Standard Deviation|Mean
790746|NCT00882687|Secondary|Ocular Itching at Day 6 (CAC 4), 5 (CAC 7)|Ocular Itching was evaluated by participants and graded with Ophthalmic Research Associates, Inc. (ORA) Scale with the score ranged from 0 to 4 (0=none; 0.5=intermittent tickle in the cornea; 1=intermittent tickle more than just the cornea; 1.5=intermittent all-over tickling sensation; 2=mild conscious itch without desire to rub; 2.5=moderate, diffuse continuous itch with desire to rub; 3=severe itch with desire to rub; 3.5=severe itch improved with minimal rubbing; 4=incapacitating itch with an irresistible urge to rub) with 0.5 point increments allowed, and lower scores indicates lesser ocular itching.|Baseline to Day 6 (CAC 4), Day 13 (CAC 7) 7 minutes post CAC|ITT population with LOCF||units on a scale||Standard Deviation|Mean
790747|NCT00882687|Primary|Conjunctival Redness at Day 14 (20 Minutes Post CAC 9)|Conjunctival Redness was evaluated by an investigator with slit lamp and graded with ORA Scale with the score ranged from 0 to 4 (0=none; 1=mild-slightly dilated blood vessels; color of vessels is typically pink; can be quadrantal; 2=moderate-more apparent dilation of blood vessels; vessel color is more intense (redder); involves the majority of the vessel bed; 3=severe-numerous and obvious dilated blood vessels; in the absence of chemosis the color is deep red, may be less red or pink in presence of chemosis, is not quadrantic; 4=extremely severe-large, numerous, dilated blood vessels characterized by unusually severe deep red color, regardless of grade of chemosis, which involves the entire vessel bed) with 0.5 point increments allowed, and lower scores indicates reduction in the conjunctival redness.|Baseline to Day 14 (20 minutes post CAC 9)|ITT population with LOCF||units on a scale||Standard Deviation|Mean
790748|NCT00882687|Primary|Conjunctival Redness at Day 7 (20 Minutes Post CAC 6)|Conjunctival Redness was evaluated by an investigator with slit lamp and graded with ORA Scale with the score ranged from 0 to 4 (0=none; 1=mild-slightly dilated blood vessels; color of vessels is typically pink; can be quadrantal; 2=moderate-more apparent dilation of blood vessels; vessel color is more intense (redder); involves the majority of the vessel bed; 3=severe-numerous and obvious dilated blood vessels; in the absence of chemosis the color is deep red, may be less red or pink in presence of chemosis, is not quadrantic; 4=extremely severe-large, numerous, dilated blood vessels characterized by unusually severe deep red color, regardless of grade of chemosis, which involves the entire vessel bed) with 0.5 point increments allowed, and lower scores indicates reduction in the conjunctival redness.|Baseline to Day 7 (20 minutes post CAC 6)|ITT population with LOCF||units on a scale||Standard Deviation|Mean
790749|NCT00882687|Primary|Ocular Itching at Day 14 (7 Minutes Post CAC 9)|Ocular Itching was evaluated by participants and graded with Ophthalmic Research Associates, Inc. (ORA) Scale with the score ranged from 0 to 4 (0=none; 0.5=intermittent tickle in the cornea; 1=intermittent tickle more than just the cornea; 1.5=intermittent all-over tickling sensation; 2=mild conscious itch without desire to rub; 2.5=moderate, diffuse continuous itch with desire to rub; 3=severe itch with desire to rub; 3.5=severe itch improved with minimal rubbing; 4=incapacitating itch with an irresistible urge to rub) with 0.5 point increments allowed, and lower scores indicates lesser ocular itching.|Baseline to Day 14 (7 minutes post CAC 9)|ITT population with LOCF||units on a scale||Standard Deviation|Mean
790750|NCT00882687|Primary|Ocular Itching at Day 7 (7 Minutes Post Conjunctival Allergen Challenge [CAC 6])|Ocular Itching was evaluated by participants and graded with Ophthalmic Research Associates, Inc. (ORA) Scale with the score ranged from 0 to 4 (0=none; 0.5=intermittent tickle in the cornea; 1=intermittent tickle more than just the cornea; 1.5=intermittent all-over tickling sensation; 2=mild conscious itch without desire to rub; 2.5=moderate, diffuse continuous itch with desire to rub; 3=severe itch with desire to rub; 3.5=severe itch improved with minimal rubbing; 4=incapacitating itch with an irresistible urge to rub) with 0.5 point increments allowed, and lower scores indicates lesser ocular itching. CAC is an initial titration challenge to determine the appropriate allergen and lowest concentration of allergen that produced a positive bilateral allergic response for each subject, defined as ≥ 2 score (0-4 point scale) in ocular itching and conjunctival redness within 10 minutes of the last titration of allergen.|Baseline to Day 7 (7 minutes post CAC 6)|Intent-to-treat (ITT) population with last observation carried forward (LOCF)||units on a scale||Standard Deviation|Mean
790751|NCT00882713|Secondary|Mean Change From Baseline in Weight Over Time|Mean change in weight was defined as the difference between mean weight at Baseline and following visits (Week 16 and Week 48).|Week 16 and Week 48|Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of evaluation were analyzed. Number of participants with available data at specified period is denoted by ‘n’.||kilogram||Standard Deviation|Mean
790801|NCT00882908|Secondary|The Number of Participants With Viral Relapse|The table below shows the number of participants who experienced viral relapse, defined as a confirmed detectable plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) level during the follow-up period in participants with undetectable plasma HCV RNA (less than 25 IU/mL undetectable) at the end of treatment.|Up to Week 72|The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.||Participants|||Number
790752|NCT00882713|Secondary|Mean Change From Baseline in Blood Pressure Over Time|Mean change in blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]) before and after dialysis was defined as the difference between mean blood pressure at Baseline and following visits (Weeks 8, 16, 24, 32, 40, and 48).|Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of evaluation were analyzed. Number of participants with available data at specified period is denoted by ‘n’.||millimeter of mercury||Standard Deviation|Mean
790753|NCT00882713|Secondary|Mean Change From Baseline in Pulse Rate Over Time|Mean change in pulse rate was defined as the difference between mean pulse rate at Baseline and following visits (Weeks 8, 16, 24, 32, 40, and 48).|Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of evaluation were analyzed. Number of participants with available data at specified period is denoted by ‘n’.||beats per minute||Standard Deviation|Mean
790754|NCT00882713|Secondary|Mean Transferrin Saturation Levels Over Time|The mean transferrin saturation (TSAT) levels over time were recorded for each participant at enrolment and at different time points during the study up to Week 48.|Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not. Number of participants with available data at specified period is denoted by ‘n’.||Percentage of Transferrin Saturation||Standard Deviation|Mean
790755|NCT00882713|Secondary|Mean Ferritin Levels Over Time|The mean ferritin levels over time were recorded for each participant at enrolment and at different time points during the study up to Week 48.|Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not. Number of participants with available data at specified period is denoted by ‘n’.||mcg/L||Standard Deviation|Mean
790756|NCT00882713|Secondary|Mean C-Reactive Protein Levels Over Time|The mean C-Reactive Protein (CRP) Levels over time were recorded for each participant at enrolment and at different time points during the study up to Week 48.|Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not. Number of participants with available data at specified period is denoted by ‘n’.||miligrams/L||Standard Deviation|Mean
790757|NCT00882713|Secondary|Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time|The mean creatinine, iron, and total iron binding capacity (TIBC) levels over time were recorded for each participant at enrolment and at different time points during the study up to Week 48.|Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not. Number of participants with available data at specified period is denoted by ‘n’.||micromole/L||Standard Deviation|Mean
790758|NCT00882713|Secondary|Mean Phosphate and Potassium Levels Over Time|The phosphate and potassium levels were recorded for each participant at enrolment and at different time points during the study up to Week 48.|Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not. Number of participants with available data at specified period is denoted by ‘n’.||milimole/L||Standard Deviation|Mean
790759|NCT00882713|Secondary|Mean White Blood Cells and Thrombocytes Over Time|The white blood cells (WBCs) and thrombocyte levels were recorded for each participant at enrolment and at different time points during the study up to Week 48.|Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not. Number of participants with available data at specified period is denoted by ‘n’.||10^9 cells/L||Standard Deviation|Mean
790760|NCT00882713|Secondary|Mean Albumin Levels Over Time|The albumin levels were recorded for each participant at enrolment and at different time points during the study up to Week 48.|Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who have been treated with at least one dose of the study drug and a safety follow-up, whether withdrawn prematurely or not. Out of 194, one participant was excluded from the ITT population due to missing hemoglobin measurement and C.E.R.A medication after Week 0.||g/L||Standard Deviation|Mean
790761|NCT00882713|Secondary|Mean Hematocrit Levels Over Time|The hematocrit (HCT) levels were recorded for each participant at enrolment and at different time points during the study up to Week 48.|Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not. Number of participants with available data at specified period is denoted by ‘n’.||Proportion of red blood cells in blood||Standard Deviation|Mean
790762|NCT00882713|Secondary|Mean Hemoglobin Levels Over Time|The Hb levels were recorded for each participant at enrolment and at different time points during the study up to Week 48.|Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not. Number of participants with available data at specified period is denoted by ‘n’.||g/dL||Standard Deviation|Mean
790763|NCT00882713|Secondary|Incidences of Red Blood Cell Transfusions During the C.E.R.A. Treatment Phase|Red Blood Cells (RBCs) transfusions were given during the treatment period in case of medical need. Blood transfusions occurred during the DTP, EEP, and during the long term safety period (LTSP) were reported.|Up to Week 52|Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not.||Number of RBCs transfusion|||Number
790817|NCT00883090|Primary|Mean Residence Time||12 weeks|The analysis population was the PK population. The PK population comprised all subjects in the safety population who completed the study (defined as having sufficient bioanalytical assessments to calculate reliable estimates of the PK parameters specified).||days||Standard Deviation|Mean
790764|NCT00882713|Secondary|Percentage of Participants Requiring Any Dose Adjustment During DTP and EEP|Percentage of participants requiring any dose adjustment during DTP (Week 1 to Week 16) and EEP (Week 17 to Week 24) is reported. The dose adjustments (increase or decrease) were required: if a single Hb concentration was either > or = 13 g/dL or < or = 9 g/dL; if the difference of 2 consecutive Hb concentrations was > or =2 g/dL; if the values of scheduled Hb assessments on the day of administration of C.E.R.A. and on the previous study visit were both out of range of 10.5 to 11.5 g/dL, the difference between the reference value (mean of Hb concentrations based on the Hb assessments at Weeks -4, -3, -2, -1, and 0) and the most recent value was >1 g/dL; if the values of the scheduled Hb assessments on the day of administration of C.E.R.A. and on the previous study visit were both out of the range 10 to 12 g/dL. Dose adjustment could be made at any time at the discretion of the clinician if clinically warranted.|DTP (Week 1 to Week 16) and EEP (Week 17 to Week 24)|ITT population included all the participants who had received at least one dose of C.E.R.A. (Week 0) and for whom data for at least one follow-up variable (laboratory data, adverse events, etc.) was available. Out of 194 participants, one was excluded from the ITT population due to missing Hb measurement and C.E.R.A drug after Week 0.||Percentage of participants|||Number
790765|NCT00882713|Secondary|Number of Participants With Any Adverse Events or Serious Adverse Events|An adverse event (AE) is untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAEs) is with any of the following outcomes: Death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, and congenital anomaly.|Up to Week 52|Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not.||Participants|||Number
790766|NCT00882713|Secondary|Mean Time Spent By Participants With Hemoglobin Range of 10.5-12.5 g/dL During the EEP|Mean time spent by participants in Hb range of 10.5-12.5 g/dL during the EEP is reported. The EEP was from Week 17 to Week 24.|EEP (Week 17 to Week 24)|ITT population included all the participants who had received at least one dose of C.E.R.A. (Week 0) and for whom data for at least one follow-up variable (laboratory data, adverse events, etc.) was available. Out of 194 participants, one was excluded from the ITT population due to missing Hb measurement and C.E.R.A drug after Week 0.||Days||Standard Deviation|Mean
790767|NCT00882713|Secondary|Percentage of Participants Maintaining Hemoglobin Concentration Within the Range of 10.5-12.5 g/dL Throughout the EEP|Percentage of participants maintaining Hb concentration within the range of 10.5-12.5 g/dL throughout the EEP is reported. The EEP was from Week 17 to Week 24.|EEP (Week 17 to Week 24)|ITT population included all the participants who had received at least one dose of C.E.R.A. (Week 0) and for whom data for at least one follow-up variable (laboratory data, adverse events, etc.) was available. Out of 194 participants, one was excluded from the ITT population due to missing Hb measurement and C.E.R.A drug after Week 0.||Percentage of participants||95% Confidence Interval|Number
790768|NCT00882713|Secondary|Mean Change in Hemoglobin Concentration Between Reference (Stability Verification Period) and the Efficacy Evaluation Period|Mean change in Hb concentration between reference SVP and the EEP is reported. The SVP was at Weeks -3, -2, -1, and EEP was from Week 17 to Week 24. Participants received epoetin alfa or beta during SVP.|SVP (Weeks -3, -2, -1) and EEP (Week 17 to Week 24)|ITT population included all the participants who had received at least one dose of C.E.R.A. (Week 0) and for whom data for at least one follow-up variable (laboratory data, adverse events, etc.) was available. Out of 194 participants, one was excluded from the ITT population due to missing Hb measurement and C.E.R.A drug after Week 0.||g/dL||Standard Deviation|Mean
790769|NCT00882713|Primary|Percentage of Participants Maintaining Mean Hemoglobin Concentration Within +/- 1 g/dL of Their Reference Hb and Between 10.5 and 12.5 g/dL During Efficacy Evaluation Period|The percentage of participants who maintained their mean Hb concentration within +/- 1 g/dL of their reference Hb and between 10.5 and 12.5 g/dL during the Efficacy Evaluation Period (EEP) is reported. The EEP was from Week 17 to Week 24. The reference Hb was calculated from the mean of Hb concentrations based upon the Hb assessments at Weeks -4, -3, -2, -1, and 0.|EEP (Week 17 to Week 24)|The per-protocol (PP) population included all participants from the intention-to-treat (ITT) population, who fulfilled inclusion/exclusion criteria as per the study protocol. A total of 123 participants were included in the PP population.||Percentage of participants||95% Confidence Interval|Number
790770|NCT00882778|Secondary|Number of Physician Reported Outcome Assessment in Prophylaxis in Percentage of Patients|Physician's assessment of prophylaxis outcome as successful, partially successful, unsuccessful, or unable to determine|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Whole population of all male patients diagnosed with haemophilia A or B with inhibitor, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days||percentage of patients|||Number
790771|NCT00882778|Secondary|Physician Reported Outcome Assessment in Prophylaxis in Number of Patients|Physician's assessment of prophylaxis outcome as successful, partially successful, unsuccessful, or unable to determine|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Whole population of all male patients diagnosed with haemophilia A or B with inhibitor, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days||patients|||Number
790772|NCT00882778|Secondary|Healthcare Resource Consumption of Total Hospital Length of Stay and School/Work Absences Per Month - Frequent Bleeding Population|Healthcare resource consumption evaluated the absolute change in number of total hospital length of stay and school/work absences during the pre-prophylaxis period to the prophylaxis period.|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Frequent bleeding population is a subset of patients in the bleeding population with at least one bleed per month in the pre-prophylaxis period of approximately 6 months.||change in days per month||Standard Deviation|Mean
790818|NCT00883090|Primary|Volume of Distribution at Steady State||12 weeks|The analysis population was the PK population. The PK population comprised all subjects in the safety population who completed the study (defined as having sufficient bioanalytical assessments to calculate reliable estimates of the PK parameters specified).||mL/kg||Standard Deviation|Mean
790773|NCT00882778|Secondary|Healthcare Resource Consumption of Total Hospital Length of Stay and School/Work Absences Per Month - Bleeding Population|Healthcare resource consumption evaluated the absolute change in number of total hospital length of stay and school/work absences during the pre-prophylaxis period to the prophylaxis period.|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Bleeding population with at least one bleed in the pre-prophylaxis of approximately 6 months.||change in days per month||Standard Deviation|Mean
790774|NCT00882778|Secondary|Healthcare Resource Consumption of Total Hospital Length of Stay and School/Work Absences Per Month - All Patients|Healthcare resource consumption evaluated the absolute change in number of total hospital length of stay and school/work absences during the pre-prophylaxis period to the prophylaxis period.|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Whole population of all male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (RFVIIa) for at least 30 days.||change in days per month||Standard Deviation|Mean
790775|NCT00882778|Secondary|Healthcare Resource Consumption of Visits, Consultations and Hospital Admissions Per Month - Frequent Bleeding Population|Healthcare resource consumption evaluated the absolute change in number of outpatient clinical visits, physician consultations and hospital admissions during the pre-prophylaxis period to the prophylaxis period.|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Frequent bleeding population is a subset of patients in the bleeding population with at least one bleed per month in the pre-prophylaxis period of approximately 6 months||change in events per month||Standard Deviation|Mean
790776|NCT00882778|Secondary|Healthcare Resource Consumption of Visits, Consultations and Hospital Admissions Per Month - Bleeding Population|Healthcare resource consumption evaluated the absolute change in number of outpatient clinical visits, physician consultations and hospital admissions during the pre-prophylaxis period to the prophylaxis period.|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Bleeding population with at least one bleed in the pre-prophylaxis period of approximately 6 months||change in events per month||Standard Deviation|Mean
790777|NCT00882778|Secondary|Healthcare Resource Consumption of Visits, Consultations, and Hospital Admissions Per Month - All Patients|Healthcare resource consumption evaluated the absolute change in number of outpatient clinical visits, physician consultations and hospital admissions during the pre-prophylaxis to the prophylaxis period.|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Whole population of all male patients diagnosed with haemophilia A or B with inhibitor, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days||change in events per month||Standard Deviation|Mean
790778|NCT00882778|Secondary|Total Bleed Episodes Per Month by Joint, Target Joint and Non-joint - Frequent Bleeding Population|Percent change in bleed episodes per month between pre-prophylaxis period and prophylaxis period by location of joint, target joint (= 3 or more documented bleeds in the same joint over the course of 6 months) or non-joint. All joints = target joints and non-target joints.|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Frequent bleeding population is a subset of patients in the bleeding population with at least one bleed per month in the pre-prophylaxis period of approx. 6 months. Patients from the French sites were not included because bleed location was not collected in these patients. Bleed episodes with no recorded locations were not included in the analysis||percent change (%) in bleeds per month|||Number
790779|NCT00882778|Secondary|Total Bleed Episodes Per Month by Joint, Target Joint and Non-joint - Bleeding Population|Percent change in bleed episodes per month between pre-prophylaxis period and prophylaxis period by location of joint, target joint (defined as 3 or more documented bleeds in the same joint over the course of 6 months) or non-joint. All joints = target joints and non-target joints.|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Bleeding population with at least one bleed in the pre-prophylaxis period of approx. 6 months. Patients from the French sites were not included because bleed location was not collected. Bleed episodes with no recorded locations were not included in the analysis||percent change (%) in bleeds per month|||Number
790780|NCT00882778|Secondary|Individual Dose by Dose Regimen and Age Group - Frequent Bleeding Population, Adult|Individual activated recombinant human factor VII dose for adult patients by dosing regimen (infrequent dosing = less than 2 doses per week, three times per week = dosing 2-4 times per week, daily = 5-7 doses per week, or frequent dosing = 7 or more doses per week).|Data was collected for the period of prophylactic treatment (prophylaxis period), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Frequent bleeding population is a subset of patients in the bleeding population with at least one bleed per month in the pre-prophylaxis period of approximately 6 months||mcg/kg||Full Range|Median
790781|NCT00882778|Secondary|Individual Dose by Dose Regimen and Age Group - Frequent Bleeding Population, Adolescent|Individual activated recombinant human factor VII dose for adolescent patients by dosing regimen (infrequent dosing = less than 2 doses per week, three times per week = dosing 2-4 times per week, daily = 5-7 doses per week, or frequent dosing = 7 or more doses per week).|Data was collected for the period of prophylactic treatment (prophylaxis period), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Frequent bleeding population is a subset of patients in the bleeding population with at least one bleed per month in the pre-prophylaxis period of approximately 6 months||mcg/kg||Full Range|Median
790782|NCT00882778|Secondary|Individual Dose by Dose Regimen and Age Group - Frequent Bleeding Population, Paediatric|Individual activated recombinant human factor VII dose for paediatric patients by dosing regimen (infrequent dosing = less than 2 doses per week, three times per week = dosing 2-4 times per week, daily = 5-7 doses per week, or frequent dosing = 7 or more doses per week).|Data was collected for the period of prophylactic treatment (prophylaxis period), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Frequent bleeding population is a subset of patients in the bleeding population with at least one bleed per month in the pre-prophylaxis period of approximately 6 months||mcg/kg||Full Range|Median
790783|NCT00882778|Secondary|Individual Dose by Dose Regimen and Age Group - Bleeding Population, Adult|Individual activated recombinant human factor VII dose for adult patients by dosing regimen (infrequent dosing = less than 2 doses per week, three times per week = dosing 2-4 times per week, daily = 5-7 doses per week, or frequent dosing = 7 or more doses per week).|Data was collected for the period of prophylactic treatment (prophylaxis period), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Bleeding population with at least one bleed in the pre-prophylaxis period of approximately 6 months||mcg/kg||Full Range|Median
790784|NCT00882778|Secondary|Individual Dose by Dose Regimen and Age Group - Bleeding Population, Adolescent|Individual activated recombinant human factor VII dose for adolescent patients by dosing regimen (infrequent dosing = less than 2 doses per week, three times per week = dosing 2-4 times per week, daily = 5-7 doses per week, or frequent dosing = 7 or more doses per week).|Data was collected for the period of prophylactic treatment (prophylaxis period), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Bleeding population with at least one bleed in the pre-prophylaxis period of approximately 6 months||mcg/kg||Full Range|Median
790785|NCT00882778|Secondary|Individual Dose by Dose Regimen and Age Group - Bleeding Population, Paediatric|Individual activated recombinant human factor VII dose for paediatric patients by dosing regimen (infrequent dosing = less than 2 doses per week, three times per week = dosing 2-4 times per week, daily = 5-7 doses per week, or frequent dosing = 7 or more doses per week).|Data was collected for the period of prophylactic treatment (prophylaxis period), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Bleeding population with at least one bleed in the pre-prophylaxis period of approximately 6 months||mcg/kg||Full Range|Median
790786|NCT00882778|Primary|Percent Change in Total Bleed Episodes Per Month by Dosing and Age Categories - Frequent Bleeding Population, Frequent Dosing|Percent change of bleeds per month between the pre-prophylaxis period and prophylaxis period. Paediatric patients below 12 years, adolescents 12-17 years, and adults at least 18 years. Frequent dosing was defined as 7 or more doses per week. All participants = paediatrics, adolescents and adults.|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Frequent bleeding population is a subset of patients in the bleeding population with at least one bleed per month in the pre-prophylaxis period of approximately 6 months||percent change (%) in bleeds per month|||Number
790787|NCT00882778|Primary|Percent Change in Total Bleed Episodes Per Month by Dosing and Age Categories - Frequent Bleeding Population, Daily Dosing|Percent change of bleeds per month between the pre-prophylaxis period and prophylaxis period. Paediatric patients below 12 years, adolescents 12-17 years, and adults at least 18 years. Daily dosing was defined as 5 to 7 doses per week. All participants = paediatrics, adolescents and adults.|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Frequent bleeding population is a subset of patients in the bleeding population with at least one bleed per month in the pre-prophylaxis period of approximately 6 months||percent change (%) in bleeds per month|||Number
790788|NCT00882778|Primary|Percent Change in Total Bleed Episodes Per Month by Dosing and Age Categories - Frequent Bleeding Population, Dosing Three Times Per Week|Percent change of bleeds per month between the pre-prophylaxis period and prophylaxis period. Paediatric patients below 12 years, adolescents 12-17 years, and adults at least 18 years. Three times per week dosing was defined as dosing two to four times per week. All participants = paediatrics, adolescents and adults.|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Frequent bleeding population is a subset of patients in the bleeding population with at least one bleed per month in the pre-prophylaxis period of approximately 6 months||percent change (%) in bleeds per month|||Number
790789|NCT00882778|Primary|Percent Change in Total Bleed Episodes Per Month by Dosing and Age Categories - Frequent Bleeding Population, Infrequent Dosing|Percent change of bleeds per month between the pre-prophylaxis period and prophylaxis period. Paediatric patients below 12 years, adolescents 12-17 years, and adults at least 18 years. Infrequent dosing was defined as less than two doses per week. All participants = paediatrics, adolescents and adults.|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Frequent bleeding population is a subset of patients in the bleeding population with at least one bleed per month in the pre-prophylaxis period of approximately 6 months||percent change (%) in bleeds per month|||Number
790790|NCT00882778|Primary|Percent Change in Total Bleed Episodes Per Month by Dosing and Age Categories - Bleeding Population, Frequent Dosing|Percent change of bleeds per month between the pre-prophylaxis period and the prophylaxis period. Paediatric patients below 12 years, adolescents 12-17 years, and adults at least 18 years. Frequent dosing was defined as 7 or more doses per week. All participants = paediatrics, adolescents and adults.|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Bleeding population with at least one bleed in the pre-prophylaxis period of approximately 6 months||percent change (%) in bleeds per month|||Number
790819|NCT00883090|Primary|Clearance||12 weeks|The analysis population was the PK population. The PK population comprised all subjects in the safety population who completed the study (defined as having sufficient bioanalytical assessments to calculate reliable estimates of the PK parameters specified).||mL/hr/kg||Standard Deviation|Mean
790791|NCT00882778|Primary|Percent Change in Total Bleed Episodes Per Month by Dosing and Age Categories - Bleeding Population, Daily Dosing|Percent change of bleeds per month between the pre-prophylaxis period and prophylaxis period. Paediatric patients below 12 years, adolescents 12-17 years, and adults at least 18 years. Daily dosing was defined as 5 to 7 doses per week. All participants = paediatrics, adolescents and adults.|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Bleeding population with at least one bleed in the pre-prophylaxis period of approximately 6 months||percent change (%) in bleeds per month|||Number
790792|NCT00882778|Primary|Percent Change in Total Bleed Episodes Per Month by Dosing and Age Categories - Bleeding Population, Dosing Three Times Per Week|Percent change of bleeds per month between the pre-prophylaxis period and prophylaxis period. Paediatric patients below 12 years, adolescents 12-17 years, and adults at least 18 years. Three times per week dosing was defined as dosing two to four times per week. All participants = paediatrics, adolescents and adults.|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Bleeding population with at least one bleed in the pre-prophylaxis period of approximately 6 months||percent change (%) in bleeds per month|||Number
790793|NCT00882778|Primary|Percent Change in Total Bleed Episodes Per Month by Dosing and Age Categories - Bleeding Population, Infrequent Dosing|Percent change of bleeds per month between the pre-prophylaxis period and prophylaxis period. Paediatric patients below 12 years, adolescents 12-17 years, and adults at least 18 years. Infrequent dosing was defined as less than two doses per week. All participants = paediatrics, adolescents and adults.|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Bleeding population with at least one bleed in the pre-prophylaxis period of approximately 6 months||percent change (%) in bleeds per month|||Number
790794|NCT00882778|Primary|Percent Change in Total Bleed Episodes Per Month Per Age Categories - Frequent Bleeding Population|Percent change of bleeds per month between the pre-prophylaxis period and the prophylaxis period. Paediatric patients below 12 years, adolescents 12-17 years, and adults at least 18 years|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Frequent bleeding population is a subset of patients in the bleeding population with at least one bleed per month in the pre-prophylaxis period of approximately 6 months||percent change (%) in bleeds per month|||Number
790795|NCT00882778|Primary|Percent Change in Total Bleed Episodes Per Month Per Age Categories - Bleeding Population|Percent change of bleeds per month between the pre-prophylaxis period and the prophylaxis period. Paediatric patients below 12 years, adolescents 12-17 years, and adults at least 18 years|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Bleeding population with at least one bleed in the pre-prophylaxis period of approximately 6 months||percent change (%) in bleeds per month|||Number
790796|NCT00882778|Primary|Percent Change in Total Bleed Episodes Per Month - Frequent Bleeding Population|Percent change of bleeds per month in the pre-prophylaxis period and bleeds per month in the prophylaxis period|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Frequent bleeding population is a subset of patients in the bleeding population with at least one bleed per month in the pre-prophylaxis period of approximately 6 months||percent change (%) in bleeds per month|||Number
790797|NCT00882778|Primary|Percent Change in Total Bleed Episodes Per Month - Bleeding Population|Percent change of bleeds per month in the pre-prophylaxis period and bleeds per month in the prophylaxis period|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Bleeding population with at least one bleed in the pre-prophylaxis period of approximately 6 months||percent change (%) in bleeds per month|||Number
790798|NCT00882908|Secondary|Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24h) for TMC435|The table below shows the median (range) AUC24h values for TMC435 for participants in each of the 4 TMC435 treatment groups. Two blood samples taken at least 2 hours apart from each other for determination of TMC435 plasma pharmacokinetics were obtained in all participants on Weeks 2, 4, 8, 12, 16, and 24 to obtain Bayesian estimates of TMC435 AUC24h (overall exposure).|Two random blood samples taken at least 2 hours apart at Weeks 2, 4, 8, 12, 16, and 24|Participants who received at least 1 dose of study medication with at least 1 post-baseline pharmacokinetic (PK) assessment were included in the PK analysis population.||ng*h/mL||Full Range|Median
790799|NCT00882908|Secondary|Plasma Concentrations of TMC435|The table below shows median (range) predose plasma concentration (C0h) values and median (range) average steady-state plasma concentration (Css,av) values for participants in each of the 4 TMC435 treatment groups.|Two random blood samples taken at least 2 hours apart at Weeks 2, 4, 8, 12, 16, and 24|Participants who received at least 1 dose of study medication with at least 1 post-baseline pharmacokinetic (PK) assessment were included in the PK analysis population.||ng/mL||Full Range|Median
790800|NCT00882908|Secondary|The Number of Participants With Abnormal Alanine Aminotransferase (ALT) Levels at Baseline Who Achieved Normalized ALT Levels at the End of Treatment (EOT)|The table below shows the number of participants with abnormal ALT levels at Baseline who achieved ALT levels within the normal range at the EOT.|Baseline (Day 1) up to Week 24 or 48|The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.||Participants|||Number
790815|NCT00883090|Secondary|Laboratory Safety Parameters|Number of participants with clinically significant laboratory safety parameter values. The laboratory safety parameters measured included serum chemistries, hematology and urinalysis.|16 weeks|The analysis population was the safety population. The safety population comprised all subjects who received a dose of Factor XIII.||participants|||Number
790802|NCT00882908|Secondary|Number of Participants With Viral Breakthrough|The table below shows the number of participants in each treatment group who experienced viral breakthrough during the TMC435 treatment period of the study, defined as a confirmed increase of more than 1 log10 IU/mL in plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) level from the lowest level reached or a confirmed value of plasma HCV RNA more than 100 IU/mL in participants whose plasma HCV RNA level had previously been below the limit of quantification (less than 25 IU/mL detectable or undetectable).|Week 24 or 48|The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.||Participants|||Number
790803|NCT00882908|Secondary|The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12)|The table below shows the percentage of participants who achieved undetectable plasma Hepatitis C virus ribonucleic acid levels at the end of treatment (EOT) and 12 Weeks after the EOT.|Up to Week 36 or 52|The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.||Percentage of participants|||Number
790804|NCT00882908|Secondary|The Percentage of Participants Achieving a Complete Early Virologic Response (cEVR)|The table below shows the percentage of participants in each treatment group who had a cEVR, defined as having undetectable plasma Hepatitis C Virus ribonucleic acid levels at Week 12.|Week 12|The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.||Percentage of participants|||Number
790805|NCT00882908|Secondary|The Percentage of Participants Achieving an Early Virologic Response (EVR)|The table below shows the percentage of participants who achieved an EVR, defined as having a change from baseline in plasma Hepatitis C virus ribonucleic acid of 2 log10 at Week 12.|Baseline (Day 1) and Week 12|The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.||Percentage of participants|||Number
790806|NCT00882908|Secondary|The Percentage of Participants Achieving a Rapid Virologic Response (RVR)|The table below shows the percentage of participants in each treatment group who achieved a RVR, defined as having undetectable plasma Hepatitis C virus ribonucleic acid levels after receiving 4 weeks of treatment.|Week 4|The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.||Percentage of participants|||Number
790807|NCT00882908|Secondary|The Percentage of Participants Who Achieved a Sustained Virologic Response 24 Weeks After the Planned End of Treatment (SVR24)|The table below shows the percentage of participants in each treatment group who achieved a SVR24, defined as having undetectable plasma Hepatitis C virus ribonucleic acid levels at the end of treatment (EOT) and 24 weeks after the EOT.|Week 48 or 72|The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.||Percentage of participants|||Number
790808|NCT00882908|Secondary|The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Greater Than or Equal to 2 log10 Drop During Treatment|The table below shows the percentage of participants in each treatment group who achieved plasma levels of HCV RNA greater than or equal to 2 log10 drop from Baseline at selected time points during treatment.|Baseline (Day 1) and Weeks, 2, 4, 8, and 12|The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.||Percentage of participants|||Number
790809|NCT00882908|Secondary|The Percentage of Participants Who Achieved Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Detectable or Undetectable During Treatment and Follow-up|The table below shows the percentage of participants in each treatment group who achieved plasma levels of HCV RNA less than 25 IU/mL detectable or undetectable at selected time points during treatment, follow-up, and at end of treatment (EOT).|Weeks 2, 4, 8, 12, 24, 36, 48, 60, 72, and at EOT (up to Week 24 or 48)|The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.||Percentage of participants|||Number
790810|NCT00882908|Secondary|The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Undetectable During Treatment and Follow-up|The table below shows the percentage of participants in each treatment group who achieved plasma HCV RNA levels of less than 25 IU/mL undetectable at selected time points during treatment, follow-up, and at end of treatment (EOT).|Weeks, 2, 4, 8, 12, 24, 36, 48, 60, 72, and at EOT (up to Week 24 or 48)|The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.||Percentage of participants|||Number
790811|NCT00882908|Primary|The Percentage of Participants Achieving a Sustained Virologic Response at Week 72 (SVRW72)|The table below shows the percentage of participants in each treatment group who achieved a SVRW72, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid levels at end of treatment (EOT) and at Week 72.|Week 72|The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.||Percentage of participants|||Number
790812|NCT00882921|Secondary|Change From Baseline in uGAG Levels to 109 Weeks|Urine GAG|Baseline to 109 Weeks|The Safety Population was defined as all enrolled patients who received any portion of a dose of Elaprase. The primary analysis of how presence of antibodies affected IRAE rates was performed based on a negative binomial regression model. This was done to account for potentially differential follow-up time between antibody groups.||mcg/mg||Standard Deviation|Mean
790813|NCT00882921|Primary|Infusion-Related Adverse Event (IRAE) Rates Between IgG Anti-idursulfase Antibody Positive (Ab+) and Anti-idursulfase IgG Antibody Negative (Ab-) Patients|The primary analysis of how presence of antibodies affected IRAE rates was performed based on a negative binomial regression model. This was done to account for potentially differential follow-up time between antibody groups.|Baseline to 109 Weeks|The Safety Population was defined as all enrolled patients who received any portion of a dose of Elaprase.||IRAE/Week|||Number
790814|NCT00883090|Secondary|Vital Signs|Number of participants with clinically significant vital signs. The vital signs measured included blood pressure, pulse rate and temperature. Clinically significant changes in vital signs were to be reported as adverse events.|16 weeks|The analysis population was the safety population. The safety population comprised all subjects who received a dose of Factor XIII.||participants|||Number
790820|NCT00883090|Primary|Area Under the Curve at Steady State||12 weeks|The analysis population was the PK population. The PK population comprised all subjects in the safety population who completed the study (defined as having sufficient bioanalytical assessments to calculate reliable estimates of the PK parameters specified).||Units*hr/mL||Standard Deviation|Mean
790821|NCT00883090|Primary|Terminal Half-life||12 weeks|The analysis population was the PK population. The PK population comprised all subjects in the safety population who completed the study (defined as having sufficient bioanalytical assessments to calculate reliable estimates of the PK parameters specified).||days||Standard Deviation|Mean
790822|NCT00883090|Primary|Incremental Recovery|Incremental recovery (U/mL/U/kg) is defined as the maximum (peak) FXIII activity (U/mL) obtained after infusion, per dose of FXIII (U/kg) administered.|12 weeks|The analysis population was the PK population. The PK population comprised all subjects in the safety population who completed the study (defined as having sufficient bioanalytical assessments to calculate reliable estimates of the PK parameters specified).||Units/mL/Units/kg||Standard Deviation|Mean
790823|NCT00883090|Primary|Time to Peak Concentration||12 weeks|The analysis population was the PK population. The PK population comprised all subjects in the safety population who completed the study (defined as having sufficient bioanalytical assessments to calculate reliable estimates of the PK parameters specified).||hr||Standard Deviation|Mean
790824|NCT00883090|Primary|Trough FXIII Concentration at Steady State||12 weeks|The analysis population was the PK population. The PK population comprised all subjects in the safety population who completed the study (defined as having sufficient bioanalytical assessments to calculate reliable estimates of the PK parameters specified).||Units/mL||Standard Deviation|Mean
790825|NCT00883090|Primary|Peak FXIII Concentration at Steady State||12 weeks|The analysis population was the pharmacokinetic (PK) population. The PK population comprised all subjects in the safety population who completed the study (defined as having sufficient bioanalytical assessments to calculate reliable estimates of the PK parameters specified).||Units/mL||Standard Deviation|Mean
790826|NCT00883103|Primary|Patient's Perception of Pain Using the Wong-Baker FACES Visual Scale: 0 - no Pain; 5 - Worst Imaginable Pain|A sterile catheter lubricated with the allocated gel was placed transurethrally into the bladder to measure the postvoid residual volume. After removal of the catheter, a cotton swab, coated with the same allocated gel, was advanced to the urethrovesical junction until resistance was felt. The angle of the swab with the horizontal plane was measured at rest and with a Valsalva maneuver. Immediately following the Q-tip test, the patient's perception of pain level was measured by Wong-Baker FACES Pain Scale, a visual scale where 0 represents no pain and 5 represents worst imaginable pain.|Immediately after the examination|All participants assigned to the lidocaine or aqueous gel groups were analyzed. There was no dropout or missing information.||Scores on a scale||Full Range|Median
790827|NCT00883116|Secondary|Number of Participants With a Serious Adverse Event (SAE), an SAE Related to Study Drug, Death as Outcome, a Peripheral Neuropathy Adverse Event (AE), a Grade 3 or Higher AE, and an AE Related to Study Drug|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related to study drug=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.|From Day 1 (first dose) to 30 days past last dose (up to Day 219); 9 cycles, or 189 days + 30 days|All participants who received at least 1 dose of ixabepilone||Participants|||Number
790828|NCT00883116|Secondary|Best Overall Response Rate|Best overall response rate was defined as the number of participants whose best response was either partial response (PR) or complete response (CR) divided by the number of participants in the treatment group. Overall tumor response was based on an integration of the evaluation of target, nontarget, and new lesions. CR=Disappearance of all clinical and radiologic evidence of target lesions. PR=At least 30% reduction in the sum of diameters of all target lesions; taking as reference the baseline study measurement. Changes in tumor measurements need not be confirmed by repeat measurements performed after the criteria for response were first met.|Date of randomization and every 6 weeks to end of treatment (9 cycles, or approximately Day 189)|All randomized participants with measurable disease||Percentage of participants||95% Confidence Interval|Number
790829|NCT00883116|Secondary|Progression-free Survival|Progression-free survival was defined as the time from randomization to the date of documented disease progression. Patients who died without a reported prior progression were considered to have progressed on the date of their death. Those who did not progress or die were censored on the date of their last tumor assessment. Participants who did not have any on-study tumor assessments were censored on the date they were randomized. Measurable disease was present if the patient had 1 or more measurable lesions.|Date of randomization to date of disease progression or death (or date of last tumor assessment for those who did not die or progress) up to approximately 22 months|All participants with measurable disease at randomization||Months||95% Confidence Interval|Median
790830|NCT00883116|Primary|Overall Survival (OS)|Survival was defined as the time from the date of randomization until the date of death. If the patient did not die, OS was censored on the last date he or she was known to be alive.|Date of randomization to date of death or last date censored to up to approximately 26 months|All randomized participants||Months||95% Confidence Interval|Median
790831|NCT00883129|Secondary|Tolerability, as Assessed by the Time to Withdrawal From the Study Drug or Meeting Protocol-defined Criteria for Treatment Failure.|The number of participants who remained in the study at the listed time points are reported|Continuous assessment from randomization to 24 months|||Participants|||Count of Participants
790832|NCT00883129|Secondary|Toxicity, as Measured by Adverse Events, Serious Adverse Events, and Death||Measured throughout the 2-year study|||Participants|||Count of Participants
790845|NCT00883181|Secondary|Percentage of Participants Who Received ESAs and Achieved Hemoglobin From 10 to 12 g/dL 9 Weeks After Initiation of ESA Treatment|The percentage of participants achieving a hemoglobin level from 10 to 12 g/dL after 9 weeks of ESA treatment.|9 weeks post initiation of ESA treatment|Participants who received treatment with an ESA||percentage of participants||95% Confidence Interval|Number
790833|NCT00883129|Secondary|Skin Involvement, as Measured by the Modified Rodnam Skin Thickness Scores (mRSS)|Skin thickness is quantified using the modified Rodnan measurement method (mRSS), with a scale that ranges from 0 (no skin involvement) to a maximum of 51. The reported skin score is determined by a clinical assessment of skin thickness, which is performed by a trained reader, and represents the sum of individual assessments that are made in each of 17 body areas. Each area is given a score in the range of 0-3 (0 = normal; 1= mild thickness; 2 = moderate; 3 = severe thickness). A higher score represents more severe skin involvement.|Measured at baseline and Months 3, 6, 9, 12, 15, 18, 21, and 24|Randomized participants with an acceptable baseline HRCT study (a pre-specified covariate) and at least one outcome measure||mRSS score||95% Confidence Interval|Mean
790834|NCT00883129|Secondary|Health-related Quality of Life as Measured by the Patient Responses to the Health Assessment Questionnaire Disability Index (HAQ-DI)|The HAQ-DI asks questions related to 8 activity domains (dressing, arising, eating, walking, hygiene, reach, grip, and common daily activities) with the patient's capacity to carry out each activity scored from 0 to 3. Scores across all domains are averaged and a higher score represents greater disability.|Measured at study entry and Months 3, 6, 9, 12, 15, 18, 21, and 24|The analysis population contains all of those with data available at the defined time point.||HAQ-DI Total Score||Standard Deviation|Mean
790835|NCT00883129|Secondary|Transitional Dyspnea Index Score|Change in breathlessness was assessed using the Transitional Dyspnea Index, which compares current symptoms to those at baseline. Total score ranges from - 9 to + 9. The lower the score, the more deterioration in severity of dyspnea.|Measured at Months 6, 12, 18, and 24|Randomized participants with an acceptable baseline HRCT study (a pre-specified covariate) and at least one outcome measure||Transitional Dyspnea Index Score||95% Confidence Interval|Mean
790836|NCT00883129|Secondary|Fibrosis Score, as Measured by Thoracic High Resolution Computerized Tomography (HRCT)|Imaging of the whole lung (WL) is performed using a volumetric high resolution computerized tomography (HRCT) scan, which is then analyzed using a computer algorithm to determine the percentage of overall pixels exhibiting features characteristic for quantitative lung fibrosis (QLF). Higher percentages for QLF-WL therefore represent greater involvement by lung fibrosis.|Measured at baseline and Month 24|Analysis was carried out in the subset of subjects that had measurable HRCT scans at both study entry and 24 months||% of lung exhibiting QLF||95% Confidence Interval|Mean
790837|NCT00883129|Secondary|Single-breath Diffusing Capacity for Carbon Monoxide (DLCO), as a Percent of the Age, Height, Gender, and Ethnicity Adjusted Predicted Value|The DLCO is a pulmonary function test that measures the capacity for the lung to carry out gas exchange between the inhaled breath and the pulmonary capillary blood vessels and the DLCO %-predicted represents the DLCO expressed as a percentage of the expected normal valued based on the participant's age, height, gender and ethnicity. The DLCO %-predicted is reduced in patients with interstitial lung disease and is used as a measure of disease severity.|Measured at study entry and Months 3, 6, 12, 15, 18, 21, and 24|Randomized participants with an acceptable baseline HRCT study (a pre-specified covariate) and at least one outcome measure||DLCO %-pred||95% Confidence Interval|Mean
790838|NCT00883129|Secondary|Total Lung Capacity (TLC), as a Percent of the Age, Height, Gender, and Ethnicity Adjusted Predicted Value|The TLC represents the total volume of air within the lung after taking the deepest breath possible and the TLC %-predicted represents the TLC expressed as a percentage of the expected normal valued based on the participant's age, height, gender and ethnicity. The TLC %-predicted is reduced in patients with interstitial lung disease and is used as a measure of disease severity.|Measured at study entry and Months 6, 12, 18, and 24|Randomized participants with an acceptable baseline HRCT study (a pre-specified covariate) and at least one outcome measure||TLC %-pred||95% Confidence Interval|Mean
790839|NCT00883129|Primary|Forced Vital Capacity (FVC), as a Percent of the Age, Height, Gender, and Ethnicity Adjusted Predicted Value|The primary outcome is the course over time from baseline to 24 months for the FVC %-predicted. The FVC %-predicted represents the adjusted volume of air (adjusted as a percentage of the expected normal valued based on the participant's age, height, gender and ethnicity) that can be forcibly exhaled from the lungs after taking the deepest breath possible. The FVC %-predicted is reduced in patients with interstitial lung disease and is used as a measure of lung involvement and disease severity.|Measured at study Baseline and Months 3, 6, 12, 15, 18, 21, and 24|Randomized participants with an acceptable baseline HRCT study (a pre-specified covariate) and at least one outcome measure||FVC %-pred||95% Confidence Interval|Mean
790840|NCT00883168|Secondary|Change From Baseline in Adult Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)|adult Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scored at day 1(baseline) and at day 14.The scale is measured from a value of 0 to 24. A negative number corresponds to a change from baseline measurement. An increased negative number is suggestive of improvement.|day 1 to day 14|Intent to treat (ITT)population includes all subjects(18 years or older) who had at least one post baseline efficacy evaluation||units on a scale||Standard Deviation|Least Squares Mean
790841|NCT00883168|Secondary|Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (iTNSS)|change from baseline in 12-hour instantaneous total nasal symptom score (iTNSS)consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary cards for the entire 14 day study period.The measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value.A greater negative score is suggestive of improved condition.|day 1 to day 14|Intent to Treat (ITT) population includes all subjects who received at least one post baseline efficacy evaluation||units on a scale||Standard Deviation|Least Squares Mean
790842|NCT00883168|Primary|Change From Baseline in 12 Hour Reflective Total Nasal Symptom Score (rTNSS)|change from baseline in 12-hour reflective total nasal symptom score (rTNSS)consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary cards for the entire 14 day study period.The measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value.An greater negative value is suggestive of improvement.|day 1 to day 14|Intent to Treat (ITT) population includes all subjects who had at least one post baseline dose efficacy evaluation||units on a scale||Standard Deviation|Least Squares Mean
790843|NCT00883181|Secondary|Number of Transfusions Per Participant in Cycles 1 to 8||Cycles 1 - 8 (approximately 24 weeks)|Full analysis set||participants|||Number
790844|NCT00883181|Secondary|Number of Participants With Systemic Transfusions in Cycles 1 to 8|Number of participants who received transfusions, including platelets, packed red blood cells, whole blood, or other, during cycles 1 to 8.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set||participants|||Number
790846|NCT00883181|Secondary|Percentage of Participants Who Received ESAs and Achieved Hemoglobin From 12 to 13 g/dL After 5 Weeks ESA Treatment|Kaplan-Meier estimate of the percentage of participants achieving a hemoglobin level from 12 to 13 g/dL during the period from five weeks after initiation of ESA treatment until the end of ESA treatment during cycles 1 to 8.|From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks.|Participants who received treatment with an ESA, and with hemoglobin < 12 g/dL at initiation of ESA treatment and still on study 5 weeks after initiation of ESA treatment.||percentage of participants||95% Confidence Interval|Number
790847|NCT00883181|Secondary|Percentage of Participants Who Received ESAs and Achieved Hemoglobin From 10 to 12 g/dL After 5 Weeks ESA Treatment|Kaplan-Meier estimate of the percentage of participants achieving a hemoglobin level from 10 to 12 g/dL during the period from five weeks after initiation of ESA treatment until the end of ESA treatment during cycles 1 to 8.|From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks.|Participants who received treatment with an ESA, and with hemoglobin < 10 g/dL at initiation of ESA treatment and still on study 5 weeks after initiation of ESA treatment.||percentage of participants||95% Confidence Interval|Number
790848|NCT00883181|Secondary|Percentage of Participants Who Received ESAs and Achieved Hemoglobin ≥ 12 g/dL After 5 Weeks ESA Treatment|Kaplan-Meier estimate of the percentage of participants achieving a hemoglobin level ≥ 12 g/dL during the period from five weeks after initiation of ESA treatment until the end of ESA treatment during cycles 1 to 8.|From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks.|Participants who received treatment with an ESA, and with hemoglobin < 12 g/dL at initiation of ESA treatment and still on study 5 weeks after initiation of ESA treatment.||percentage of participants||95% Confidence Interval|Number
790849|NCT00883181|Secondary|Percentage of Participants Who Received ESAs and Achieved Hemoglobin ≥ 11 g/dL After 5 Weeks ESA Treatment|Kaplan-Meier estimate of the percentage of participants achieving a hemoglobin level ≥ 11 g/dL during the period from five weeks after initiation of ESA treatment until the end of ESA treatment during cycles 1 to 8.|From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks.|Participants who received treatment with an ESA, and with hemoglobin < 11 g/dL at initiation of ESA treatment and still on study 5 weeks after initiation of ESA treatment.||percentage of participants||95% Confidence Interval|Number
790850|NCT00883181|Secondary|Percentage of Participants Who Received ESAs and Achieved Hemoglobin ≥ 10 g/dL After 5 Weeks ESA Treatment|Kaplan-Meier estimate of the percentage of participants achieving a hemoglobin level ≥ 10 g/dL during the period from five weeks after initiation of ESA treatment until the end of ESA treatment during cycles 1 to 8.|From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks.|Participants who received treatment with an ESA, and with hemoglobin < 10 g/dL at initiation of ESA treatment and still on study 5 weeks after initiation of ESA treatment.||percentage of participants||95% Confidence Interval|Number
790851|NCT00883181|Secondary|Percentage of Participants Who Received ESAs and Achieved Hemoglobin ≥ 9 g/dL After 5 Weeks ESA Treatment|Kaplan-Meier estimate of the percentage of participants achieving a hemoglobin level ≥ 9 g/dL during the period from five weeks after initiation of ESA treatment until the end of ESA treatment during cycles 1 to 8.|From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks.|Participants who received treatment with an ESA and with hemoglobin < 9 g/dL at initiation of ESA treatment and still on study 5 weeks after initiation of ESA treatment.||percentage of participants||95% Confidence Interval|Number
790852|NCT00883181|Secondary|Percentage of Participants Who Received ESAs and Achieved Hematopoietic Response|Kaplan-Meier estimate of the percentage of participants in cycles 1 to 8 receiving ESA treatment who achieved a hematopoietic response during the ESA treatment phase, defined as a hemoglobin concentration ≥ 12 g/dL or a ≥ 2 g/dL rise in hemoglobin after starting ESA treatment.|Cycles 1 - 8 (approximately 24 weeks)|Participants who received treatment with an ESA||percentage of participants||95% Confidence Interval|Number
790853|NCT00883181|Secondary|Change in Hemoglobin During ESA Treatment Phase||Initiation of ESA treatment (last assessment on or prior to ESA day 1) and at end of ESA treatment; median duration of ESA treatment was 4 weeks, maximum was 23 weeks.|Participants who received treatment with an ESA and with hemoglobin measurements available at both time points.||g/dL||Standard Deviation|Mean
790854|NCT00883181|Secondary|Percentage of Participants Who Received ESAs and Required a Red Blood Cell (RBC) Transfusion After 5 Weeks of ESA Treatment|Kaplan-Meier estimate of the percentage of participants with RBC transfusions from five weeks post initiation of ESA treatment until the end of ESA treatment during cycles 1 to 8.|From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks.|Participants who received treatment with an ESA and still on study 5 weeks after initiation of ESA treatment.||percentage of participants||95% Confidence Interval|Number
790855|NCT00883181|Secondary|Number of Clinical Visits in Cycles 1-8 by ESA Use|The average number of clinical visits per month (28 day period) during cycles 1 to 8 and during the period of ESA treatment in cycles 1 to 8.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set||visits per month||Standard Deviation|Mean
790856|NCT00883181|Secondary|Hemoglobin Level at Initiation of Erythropoiesis-stimulating Agent Treatment||Cycles 1 - 8 (approximately 24 weeks)|Participants who received treatment with an ESA||participants|||Number
790857|NCT00883181|Secondary|Reason for Treatment With Erythropoiesis-stimulating Agents|The reason treatment with an ESA was initiated as recorded by the investigator; participants may have more than one reason for initiating treatment.|Cycles 1 - 8 (approximately 24 weeks)|Participants who received treatment with an ESA||participants|||Number
790858|NCT00883181|Secondary|Duration of Treatment With Erythropoiesis-stimulating Agents (ESAs)||Cycles 1 - 8 (approximately 24 weeks)|Participants who received treatment with an ESA||weeks||Standard Deviation|Mean
791097|NCT00873821|Primary|Number of Participants With Any Clinical Adverse Experience|An adverse experience was defined as any unfavorable and unintended change in the structure or function of the body temporally associated with the use of study drug. Adverse experiences were collected using Medical Dictionary for Regulatory Activities (MedDRA) version 13.0.|2 months|All study participants||participants|||Number
790859|NCT00883181|Secondary|Time to Disease Progression|Time to disease progression was calculated from cycle 1 day 1 to a date at which disease progression was first recorded. Participants who died due to causes other than disease progression were censored at the date of death. Participants who were alive and whose disease had not progressed at the most recent contact, or who were lost to follow-up, or with missing data, were censored at the date of last contact. Median time to disease progression was estimated from the Kaplan-Meier survival function.|From cycle 1, day 1 until end of the long-term follow-up; median time on follow-up from cycle 1, day 1 was 52 months.|Full analysis set||months||95% Confidence Interval|Median
790860|NCT00883181|Secondary|Number of Participants With Hematological Toxicities|The number of participants experiencing treatment related grade 3 and 4 hematological toxicities during cycles 1 to 8. Participants experiencing both Grade 3 and Grade 4 toxicities are reported under Grade 4 only (maximum toxicity). Toxicity grades for hematology data are defined according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0: Absolute neutrophil count (ANC) - Grade 3: < 1.0 - 0.5 x 10^9/L; ANC - Grade 4: < 0.5 x 10^9/L; White blood cells (WBC) - Grade 3: < 2.0 - 1.0 x 10^9/L; WBC - Grade 4: < 1.0 x 10^9/L; Hemoglobin - Grade 3: < 8.0 - 6.5 g/dL; Hemoglobin - Grade 4: < 6.5 g/dL; Platelets - Grade 3: < 50 - 25 x 10^9/L; Platelets - Grade 4: < 25 x 10^9/L.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set||participants|||Number
790861|NCT00883181|Secondary|Investigator Assessed Clinical Response at End of Treatment||End of treatment (approximately 24 weeks)|Full analysis set||participants|||Number
790862|NCT00883181|Secondary|Number of Participants With Unplanned Hospitalizations|Unplanned hospitalizations included only those which involved an overnight stay and occurred in cycles 1 to 8.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set||participants|||Number
790863|NCT00883181|Secondary|Number of Participants With Systemic Anti-infective Use in Cycles 1 to 8|Number of participants with systemic anti-infective use, including antibiotics, anti-fungal and virostatic for prophylaxis or treatment.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set||participants|||Number
790864|NCT00883181|Secondary|Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8|A dose reduction in a given cycle is defined as a ≥ 15% reduction in dose of any chemotherapy agent planned for that cycle, relative to the dose planned at the baseline visit for that cycle.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants with actual regimens as planned and with ≥ 15% chemotherapy dose reduction in any cycle.||cycles|Cycles with ≥ 15% dose reduction||Number
790865|NCT00883181|Secondary|Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8|A dose delay is defined as a delay of > 3 days in the start of chemotherapy measured since the start of the previous cycle.|Cycles 2 - 8 (approximately 21 weeks)|Full analysis set participants who received more than 1 cycle of chemotherapy and had > 3 days delay in one or more cycles||cycles|Cycles with > 3 days delay||Number
790866|NCT00883181|Secondary|Percentage of Cycles With Chemotherapy Dose Reductions|A dose reduction in a given cycle is defined as a ≥ 15% reduction in dose of any chemotherapy agent planned for that cycle, relative to the dose planned at the baseline visit for that cycle.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants with actual regimens as planned (17 participants received a different regimen to what was planned and are thus excluded)||percentage of cycles|Total cycles||Number
790867|NCT00883181|Secondary|Percentage of Participants With Chemotherapy Dose Reductions|A participant is considered to have a dose reduction in a given cycle if there was a ≥ 15% reduction in dose of any chemotherapy agent planned for that cycle, relative to the dose planned at the baseline visit for that cycle.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants with actual regimens as planned (17 participants received a different regimen to what was planned and are thus excluded)||percentage of participants||95% Confidence Interval|Number
790868|NCT00883181|Secondary|Percentage of Cycles With Chemotherapy Dose Delays|A dose delay is defined as a delay of > 3 days in the start of chemotherapy measured since the start of the previous cycle. The percentage of cycles delayed are summarized by the length of delay (> 3 days, > 5 days, and > 7 days) across cycles 2 through 8.|Cycles 2 - 8 (approximately 21 days)|Full analysis set participants who received more than 1 cycle of chemotherapy||percentage of cycles|Total cycles||Number
790869|NCT00883181|Secondary|Percentage of Participants With Chemotherapy Dose Delays in Cycles 2 Through 8|A dose delay is defined as a delay of more than 3 days in the start of chemotherapy measured since the start of the previous cycle. The percentage of participants with delays in chemotherapy administration are summarized by the length of delay (> 3 days, > 5 days, and > 7 days) across cycles 2 through 8.|Cycles 2 - 8 (approximately 21 weeks)|Full analysis set participants who received more than 1 cycle of chemotherapy||percentage of participants||95% Confidence Interval|Number
790870|NCT00883181|Secondary|Number of Days of Treatment in Participants Receiving Treatment With Any Daily G-CSF||Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants who received treatment with any daily G-CSF||days||Standard Deviation|Mean
790871|NCT00883181|Secondary|Number of Days of Treatment in Participants Receiving Treatment With Pegfilgrastim|The average number of days of pegfilgrastim use per cycle was calculated across all administered cycles.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants who received treatment with pegfilgrastim||days||Standard Deviation|Mean
790872|NCT00883181|Primary|Percentage of Participants Receiving Treatment With Any Other G-CSF Who Experienced Febrile Neutropenia|FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Treatment with any other G-CSF is defined as participants who started other G-CSF treatment after day 7 of any cycle if chemotherapy completed by day 7 and after day 11 of any cycle if chemotherapy completed after day 7.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants who received treatment with any other G-CSF||percentage of participants||95% Confidence Interval|Number
790873|NCT00883181|Primary|Percentage of Participants Receiving Treatment With Any Daily G-CSF Who Experienced Febrile Neutropenia|FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Treatment with any daily G-CSF is defined as participants who started daily G-CSF treatment after day 7 of any cycle if chemotherapy completed by day 7 and after day 11 of any cycle if chemotherapy completed after day 7.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants who received treatment with any daily G-CSF||percentage of participants||95% Confidence Interval|Number
790874|NCT00883181|Primary|Percentage of Participants Receiving Treatment With Pegfilgrastim Who Experienced Febrile Neutropenia|FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Treatment with pegfilgrastim is defined as participants who started pegfilgrastim treatment after day 7 of any cycle if chemotherapy completed by day 7 and after day 11 of any cycle if chemotherapy completed after day 7.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants who received treatment with pegfilgrastim||percentage of participants||95% Confidence Interval|Number
790875|NCT00883181|Primary|Percentage of Participants Receiving Secondary Prophylaxis With an Other G-CSF Who Experienced Febrile Neutropenia|FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Secondary prophylaxis was defined as receiving any daily G-CSF starting in cycle 2 onwards on day 1 to 7 if chemotherapy completed by day 7 and day 1 to 11 if chemotherapy completed after day 7. Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants were assigned to a G-CSF use group that represented the ‘best’ G-CSF therapy they received at any point in the study. Adherence of G-CSF support in subsequent cycles was not required for secondary prophylaxis; just an initiation of G-CSF support in the beginning of cycle 2 or later. Results include the FN event that may have triggered the secondary prophylaxis treatment.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants who received secondary prophylaxis with other G-CSF||percentage of participants||95% Confidence Interval|Number
790876|NCT00883181|Primary|Percentage of Participants Receiving Primary Prophylaxis With an Other G-CSF Who Experienced Febrile Neutropenia|FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Primary prophylaxis was defined as receiving any other G-CSF starting in cycle 1 on day 1 to 7 if chemotherapy completed by day 7 and day 1 to 11 if chemotherapy completed after day 7. Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants were assigned to a G-CSF use group that represented the ‘best’ G-CSF therapy they received at any point in the study. Participants who received G-CSF support from the beginning of cycle 1 were assigned to primary prophylaxis regardless of whether they continued to receive G-CSF support in subsequent cycles.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants who received primary prophylaxis with other G-CSF||percentage of participants||95% Confidence Interval|Number
790877|NCT00883181|Secondary|Number of Days of Prophylaxis in Participants Receiving Secondary Prophylaxis With Any Daily G-CSF|The average number of days of daily G-CSF use per cycle was calculated across all administered cycles.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants who received secondary prophylaxis with any daily G-CSF.||days||Standard Deviation|Mean
790878|NCT00883181|Secondary|Number of Days of Prophylaxis in Participants Receiving Secondary Prophylaxis With Pegfilgrastim|The average number of days of pegfilgrastim use per cycle was calculated across all administered cycles.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants who received secondary prophylaxis with pegfilgrastim||days||Standard Deviation|Mean
790879|NCT00883181|Secondary|Number of Days of Prophylaxis in Participants Receiving Primary Prophylaxis With Any Daily G-CSF|The average number of days of daily G-CSF use per cycle was calculated across all administered cycles.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants who received primary prophylaxis with any daily G-CSF||days||Standard Deviation|Mean
790880|NCT00883181|Secondary|Number of Days of Prophylaxis in Participants Receiving Primary Prophylaxis With Pegfilgrastim|The average number of days of pegfilgrastim use per cycle was calculated across all administered cycles.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants who received primary prophylaxis with pegfilgrastim||days||Standard Deviation|Mean
790881|NCT00883181|Primary|Percentage of Participants Receiving Secondary Prophylaxis With Any Daily G-CSF Who Experienced Febrile Neutropenia|FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Secondary prophylaxis was defined as receiving any daily G-CSF starting in cycle 2 onwards on day 1 to 7 if chemotherapy completed by day 7 and day 1 to 11 if chemotherapy completed after day 7. Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants were assigned to a G-CSF use group that represented the ‘best’ G-CSF therapy they received at any point in the study. Adherence of G-CSF support in subsequent cycles was not required for secondary prophylaxis; just an initiation of G-CSF support in the beginning of cycle 2 or later. Results include the FN event that may have triggered the secondary prophylaxis treatment.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants who received secondary prophylaxis with any daily G-CSF||percentage of participants||95% Confidence Interval|Number
790882|NCT00883181|Primary|Percentage of Participants Receiving Secondary Prophylaxis With Pegfilgrastim Who Experienced Febrile Neutropenia|FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Secondary prophylaxis with pegfilgrastim was defined as receiving pegfilgrastim starting in cycle 2 onwards on day 1 to 7 if chemotherapy completed by day 7 and day 1 to 11 if chemotherapy completed after day 7. Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants were assigned to a G-CSF use group that represented the ‘best’ G-CSF therapy they received at any point in the study. Adherence of G-CSF support in subsequent cycles was not required for secondary prophylaxis; just an initiation of pegfilgrastim support in the beginning of cycle 2 or later. Results include the FN event that may have triggered the secondary prophylaxis treatment.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants who received secondary prophylaxis with pegfilgrastim||percentage of participants||95% Confidence Interval|Number
791015|NCT00884117|Secondary|Time to Non-Detection of Viral RNA Among Participants With H1N1pdm09 Infections|Time to non-detection/viral clearance was the time between symptom onset and the day on which viral RNA was no longer detected, or the last visit date if the participant was not RNA-negative at that visit. Time to non-detection/viral clearance was estimated using Kaplan-Meier analysis and expressed in days.|From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10)|ALCIP Population. The “Number of Participants Analyzed” reflects the number of participants with H1N1pdm09 infection who provided sufficient post-Baseline data.||days||95% Confidence Interval|Median
790883|NCT00883181|Primary|Percentage of Participants Receiving Primary Prophylaxis With Any Daily G-CSF Who Experienced Febrile Neutropenia|FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Primary prophylaxis was defined as receiving any daily G-CSF (e.g. filgrastim or lenograstim) starting in cycle 1 on day 1 to 7 if chemotherapy completed by day 7 and day 1 to 11 if chemotherapy completed after day 7. Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants were assigned to a G-CSF use group that represented the ‘best’ G-CSF therapy they received at any point in the study. Participants who received G-CSF support from the beginning of cycle 1 were assigned to primary prophylaxis regardless of whether they continued to receive G-CSF support in subsequent cycles.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants who received primary prophylaxis with any daily G-CSF||percentage of participants||95% Confidence Interval|Number
790884|NCT00883181|Primary|Percentage of Participants Receiving Primary Prophylaxis With Pegfilgrastim Who Experienced Febrile Neutropenia|FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Primary prophylaxis with pegfilgrastim was defined as receiving pegfilgrastim starting in cycle 1 on day 1 to 7 if chemotherapy completed by day 7 and day 1 to 11 if chemotherapy completed after day 7. Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants were assigned to a G-CSF use group that represented the ‘best’ G-CSF therapy they received at any point in the study. Participants who received G-CSF support from the beginning of Cycle 1 were assigned to primary prophylaxis regardless of whether they continued to receive G-CSF support in subsequent cycles.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants who received primary prophylaxis with pegfilgrastim||percentage of participants||95% Confidence Interval|Number
790885|NCT00883181|Primary|Percentage of Participants Who Received No Prophylaxis or Treatment With Granulocyte Colony-stimulating Factors (G-CSF) Who Experienced Febrile Neutropenia|FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants in the No G-CSF use group received no G-CSF prophylaxis or treatment at any time during cycles 1 to 8.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants who received no prophylaxis or treatment with any G-CSF||percentage of participants||95% Confidence Interval|Number
790886|NCT00883181|Secondary|Number of Participants Who Received G-CSF During Cycles 1 to 8||Cycles 1 - 8 (approximately 24 weeks)|Full analysis set||participants|||Number
790887|NCT00883181|Primary|Percentage of Participants With Febrile Neutropenia (FN)|Febrile neutropenia was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm².|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set; Note: One participant with breast cancer had disease stage missing.||percentage of participants||95% Confidence Interval|Number
790888|NCT00883233|Primary|Local Tolerability Was Analyzed in Terms of Worst Score Post-Baseline.|Total Sum Score (TSS) is the sum of the 4 local tolerability scores for dryness, erythema, scaling and stinging/burning evaluated at each visit [None=0, Mild=1, Moderate=2 and Severe=3]. In consequence, it ranges from 0 [better outcome] to 12 [worse outcome]and was calculated for each study visit.|Week 4|||Scores on a scale||Standard Deviation|Mean
790889|NCT00883246|Secondary|Alternative Patency Rate (Peak Systolic Velocity ≤ 2.4) at 1 Year (in Patients Treated for Claudication RCC 1-3)|Defined by the duplex ultrasound measurement of peak systolic velocity ration ≤ 2.4 at the target lesion (s) with no clinically-driven re- intervention with the treated segment in subjects who have claudication at time of enrollment.|1 year|Lesions in patients with claudication at baseline||percentage of lesions|Participants||Number
790890|NCT00883246|Secondary|Wound Healing (in Patients Treated for Critical Limb Ischemia and With Wounds RCC 5-6)|Wound healing at three months was defined as a decrease of at least one Wagner Classification grade of the wound at three months compared to baseline in subjects who have Rutherford Clinical Category score of 5 or 6 at the time of enrollment.|3 months|Patients with wounds at baseline who had wound assessment scores at baseline and at 3 months.||percentage of patients|||Number
790891|NCT00883246|Secondary|Amputation-Free Survival (in Patients Treated for Claudication RCC 1-3)|Amputation-Free Survival in Claudicants at One Year was defined as freedom from a major, unplanned amputation of the target limb through the one year visit in subjects who have claudication at time of enrollment.|One Year|All claudicants.||percentage of patients|||Number
790892|NCT00883246|Secondary|Primary Patency (in Patients Treated for Critical Limb Ischemia RCC 4-6)|The primary patency for CLI was defined by duplex ultrasound measurement of peak systolic velocity ratio ≤ 3.5 at the target lesion(s) with no clinically-driven reintervention within the treated segment in subjects who have CLI at time of enrollment|One Year|All patients with CLI.||percentage of lesions|Participants||Number
790893|NCT00883246|Secondary|Secondary Patency (in Patients Treated for Claudication RCC 1-3)|Secondary patency was defined as measured by duplex ultrasound peak systolic velocity ratio ≤ 3.5 maintained by repeat percutaneous intervention in subjects who have claudication; estimated as freedom from loss of patency by the Kaplan-Meier method at one year.|One Year|All claudicants.||percentage of lesions|Participants||Number
790894|NCT00883246|Secondary|Ankle-Brachial Index (in All Patients Enrolled)|Change in Ankle-Brachial Index at One Year was calculated and percentage of subjects with an increase (improvement) in the ankle-brachial index (ABI) at one year compared to baseline in subjects with compressible arteries and baseline ABI < 0.9 was calculated.|1 Year|All patients with compressible arteries and a baseline ABI < 0.9.||percentage of patients|||Number
790895|NCT00883246|Secondary|Rutherford Clinical Category (in All Patients Enrolled)|Change in RCC at One Year was assessed and percentage of subjects with an improvement in clinical status indicated by a decrease of one or more in RCC at one year compared to baseline, that is attributable to the treated limb (in cases of bilateral disease), was calculated.|1 Year|All patients with RCC data at baseline and 1 year||percentage of patients|||Number
791217|NCT00875433|Secondary|Time From Dosing to the Maximum Concentration (Tmax)|tmax represents the time from dosing to the maximum concentration of afatinib in plasma on Day 1.|0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 1|TS.||hours||Full Range|Median
790896|NCT00883246|Secondary|Walking Impairment Questionnaire Score (in Patients Treated for Claudication RCC 1-3)|WIQ Walking Distance Scores at Baseline and One Year are presented for subjects who have claudication. The Walking Improvement Questionnaire (WIQ) is a validated method to assess objective improvement in functional walking ability of subjects with intermittent claudication. Difficulty walking a distance was self-assessed at baseline by the patient (prior to treatment) and at the one year follow up visit. Scale ranges from 0 (minimum) to 100 (maximum), with larger numbers representing better outcomes. An increase in WIQ scores at 1 year represents an improvement over baseline.|Baseline and 1 Year|All subjects treated for claudication RCC 1-3 with completed WIQ forms||units on a scale||Standard Deviation|Mean
790897|NCT00883246|Secondary|Major Adverse Event Rate (in All Patients Enrolled)|Major Adverse Event Rate at One Year was defined as clinically-driven target vessel revascularization, major unplanned amputation of the treated limb, or all-cause mortality within one year, as classified by the Clinical Events Committee (CEC).|One Year|||percentage of patients|||Number
790898|NCT00883246|Secondary|Major Adverse Event Rate (in All Patients Enrolled)|Major Adverse Event Rate (MAE) at 30 Days was defined as clinically-driven target vessel revascularization (TVR), major unplanned amputation of treated limb, or all-cause mortality within 30 days post procedure, as classified by the Clinical Events Committee (CEC).|30 Days|||percentage of patients|||Number
790899|NCT00883246|Secondary|Procedural Success (in All Patients Enrolled)|Procedure success was defined as ≤ 30% residual stenosis following use of SilverHawk device and adjunctive endovascular interventions (if required) as measured by angiography|Immediately following use of the SilverHawk and adjunctive devices|All lesions with angiographic core lab assessment of residual stenosis at the end of the procedure were included||percentage of lesions|Participants||Number
790900|NCT00883246|Secondary|Device Success (in All Patients Enrolled)|Device success was defined as ≤ 30% residual stenosis following use of the SilverHawk device, as measured by angiography, without adjunctive endovascular interventions.|Immediately following use of the SilverHawk device|Lesions with core angiographic laboratory measurements of residual stenosis||percentage of Lesions|Participants||Number
790901|NCT00883246|Primary|Amputation-Free Survival at 1 Year (in Patients Treated for Critical Limb Ischemia RCC 4-6)|The primary endpoint for CLI was amputation-free survival at one year, defined as freedom from a major, unplanned amputation of the target limb through the 1-year visit in subjects who have CLI (RCC 4 – 6) at time of enrollment.|One Year|||percentage of subjects|||Number
790902|NCT00883246|Primary|Primary Patency Rate (in Patients Treated for Claudication RCC 1-3)|The primary endpoint analysis for claudication subjects was primary patency rate at one year, defined by duplex ultrasound measurement of peak systolic velocity ratio ≤ 3.5 at the target lesion(s) with no clinically-driven reintervention within the treated segment in subjects who had claudication (RCC of 1 – 3) at time of enrollment.|One year|Kaplan-Meier estimate of the freedom from loss of primary patency in lesions (N=743 lesions)||percentage of lesions|Participants||Number
790903|NCT00883337|Secondary|Extension Treatment Period: ARR Poisson Regression Estimates|"ARR was obtained from the total number of confirmed relapses that occurred during the treatment period divided by the sum of the standardized treatment durations.To account for the different treatment durations among participants, a Poisson Regression Model with robust error variance was used (total number of confirmed relapses as response variable; log-transformed treatment duration as offset variable; treatment group, region of enrolment and baseline EDSS stratum as covariates)."|Extension treatment period (Maximum: 197 weeks)|ITT population.||relapses per year||95% Confidence Interval|Number
790904|NCT00883337|Secondary|Extension Treatment Period: Overview of AEs|AEs were any unfavourable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.|From first intake of study drug in extension treatment period up to 28 days after the last intake in the extension treatment period|Safety population. Participants were considered in the treatment group to which they were randomized regardless of the drug they actually received.||participants|||Number
790905|NCT00883337|Secondary|Core Treatment Period: Overview of Adverse Events [AE]|AE are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.|from first study drug intake up to 112 days after last intake in the core treatment period or up to first intake in the extension treatment period, whichever occurred first|"Safety population: all randomized and treated participants. Participants were considered according to the drug actually received.
The participant randomized to Teriflunomide 14 mg group who received Teriflunomide 7 mg was analyzed in the Teriflunomide 7 mg group."||participants|||Number
790906|NCT00883337|Secondary|Core Treatment Period: Treatment Satisfaction Questionnaire for Medication [TSQM] Scores|TSQM version 1.4 is an instrument to assess patients' satisfaction with medication. It consists of 13 questions that cover three dimensions (effectiveness, side effects and convenience) plus a global satisfaction question. Four scores ranging from 0 to 100 (extremely satisfied) are obtained. Least-square means were estimated using a Mixed-effect model with repeated measures [MMRM] on TSQM score data (treatment group, region of enrollment, baseline EDSS stratum, visit, treatment-by-visit interaction as factors).|48 weeks|ITT population.||units on a scale||Standard Error|Least Squares Mean
790907|NCT00883337|Secondary|Core Treatment Period: Change From Baseline in Fatigue Impact Scale (FIS) Total Score|"FIS is a subject-reported scale that qualifies the impact of fatigue on daily life in patients with MS. It consists of 40 statements that measure fatigue in three areas; physical, cognitive, and social.
FIS total score ranges from 0 (no problem) to 160 (extreme problem).
Least-square means were estimated using a Mixed-effect model with repeated measures [MMRM] on FIS total score data (treatment group, region of enrollment, baseline EDSS stratum, visit, treatment-by-visit interaction, baseline value, and baseline-by-visit interaction as factors)."|Baseline (before randomization) and 48 weeks|ITT population.||units on a scale||Standard Error|Least Squares Mean
790908|NCT00883337|Secondary|Core Treatment Period: Annualized Relapse Rate [ARR] - Poisson Regression Estimates|"ARR is obtained from the total number of confirmed relapses that occured during the treatment period divided by the sum of the treatment durations.
To account for the different treatment durations among participants, a Poisson regression model with robust error variance was used (total number of confirmed relapses as response variable; log-transformed treatment duration as offset variable; treatment group, region of enrollment and baseline EDSS stratum as covariates)."|Core treatment period between 48 and 118 weeks depending on when the participant was enrolled|ITT population.||relapses per year||95% Confidence Interval|Number
790909|NCT00883337|Primary|Core Treatment Period: Time to Failure: Kaplan-Meier Estimates of the Rate of Failure at Timepoints|"Probability of disability progression at 24, 48 and 96 weeks was estimated using Kaplan-Meier method on the time to failure defined as the time from randomization to failure. Participants free of failure were censored at the date of last treatment.
Kaplan-Meier method consists in computing probabilities of non occurrence of event at any observed time of event and multiplying successive probabilities for time ≤t by any earlier computed probabilities to estimate the probability of being event-free for the amount of time t. Probability of event at time t is 1 minus the probability of being event-free for the amount of time t."|Core treatment period between 48 and 118 weeks depending on when the participant was enrolled|ITT population.||percent probability||95% Confidence Interval|Number
790910|NCT00883337|Primary|Core Treatment Period: Overview of Failures|"Failure was defined as the first occurence of confirmed relapse or permanent treatment discontinuation (for any cause) which ever came first. If no events occurred, the participant was considered free of failure.
Each episode of relapse - appearance, or worsening of a clinical symptom that was stable for at least 30 days, that persisted for a minimum of 24 hours in the absence of fever - was to be confirmed by an increase in Expanded Disability Status Scale [EDSS] score or Functional System scores."|Core treatment period between 48 and 118 weeks depending on when the participant was enrolled|Intent-to-treat population: all randomized participants. Participants were considered in the treatment group to which they were randomized regardless of the drug they actually received.||participants|||Number
790911|NCT00883389|Primary|Qualitative Survey Assessmentof Perceived Usefulness of the Med-alert Device.|"Qualitative questionnaire with primary assessment: How useful do you think the Med-alert device will be for future healthcare. Response recorded based on a Likert scale with response of 0 = not useful, 1 = somewhat useful, 2 = extremely useful"|3 months|||Likert scale||Inter-Quartile Range|Median
790912|NCT00883493|Secondary|Treatment Satisfaction Questionnaire (TSQ) Scores.|"The 14-item TAQ questionnaire evaluates the patient’s overall level of satisfaction with the study medication, the effectiveness, side effects and convenience of the medication.
Effectiveness, side effects, convenience and global satisfaction is rated on a scale of 0 being the worst and 100 being very effective, no side effects or very convenient or very satisfied. Overall satisfaction is rated over a score of 5 and 5 being the best overall satisfaction."|baseline, 8 weeks|The analysis has been performed in modified Per Protocol (PP) population as this Outcome Measure was included after protocol amendment at the stage the recruitment period was already on-going.||Scores on a scale||Standard Deviation|Mean
790913|NCT00883493|Secondary|Change in the Sheehan Disability Scale (SDS) Total Score.|"The mean change in the SDS Total score from baseline to week 8 (baseline- week 8).
Sheehan Disability Scale is a 5 item scale, with a visual analog scale evaluating work/school work, social life and family life ranging from 0 to a maximum score of 30. Each one of the 3 domains is rated from 0-10 (no impairment to most severe impairment) with evaluation of not at all (0), mild (1-3), moderate (4-6), marked (7-9) and extreme (10) disability. A total score will be calculated. A score of 30 indicates most severe impairment."|baseline, 8 weeks|The analysis has been performed in modified Per Protocol (PP) population as this Outcome Measure was included after protocol amendment at the stage the recruitment period was already on-going.||scores on a scale||95% Confidence Interval|Mean
790914|NCT00883493|Secondary|Change in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Total Score.|"The mean change in (Q-LES-Q–Short Form) Total Score from baseline to week 8 was calculated by subtracting the 8 week value from baseline value (baseline - week 8).
The Q-LES-Q-SF is a patient self assessment questionnaire consisting of 16 self-rated questions (1 being very poor - 5 very good); the first 14 will be incorporated into a total score. Higher scores indicate better quality of life."|baseline, 8 weeks|The analysis has been performed in modified Per Protocol (PP) population as this Outcome Measure was included after protocol amendment at the stage the recruitment period was already on-going.||scores on a scale||Standard Deviation|Mean
790915|NCT00883493|Secondary|Change in the Pittsburgh Sleep Quality Index (PSQI)Total Score.|"The mean change in PSQI score from baseline to final assessment at week 8 was calculated as baseline - week 8.
PSQI evaluates 7 areas of quality and pattern of sleep: sleep quality, duration getting to sleep, sleep duration, sleep adequacy, sleep disturbance, use of sleeping pill, and somnolence). Each area is rated on a scale from 0 (better) to 3 (worse) with a total score ranging from 0 to 21. Reduction in total scores are associated with better sleep quality."|Baseline, 8 weeks|The analysis has been performed in modified Per Protocol (PP) population as this Outcome Measure was included after protocol amendment at the stage the recruitment period was already on-going.||Scores on a scale||95% Confidence Interval|Mean
790916|NCT00883493|Secondary|Change in Young Mania Rating Scale (YMRS) Total Score.|"The YMRS is a rating scale to assess manic symptoms. The scale has 11 items and is based upon patient’s subjective report of his or hers clinical condition over the previous 48 hours.
The mean change in YMRS Total score reported was calculated as baseline - week 8.
The YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in manic symptoms. Total score ≤12 indicates remission (13-19=minimal symptoms; 20-25=mild mania, 26-37=moderate mania, 38-60=severe mania)."|baseline, 8 weeks|The analysis population was “Per Protocol” (PP).||scores on a scale||Standard Deviation|Mean
790917|NCT00883493|Secondary|Change in the Clinical Global Impression Severity (CGI-S) Score.|"The reported mean change in the CGI-S score was calculated as baseline - week 8.
CGI-S is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment. A patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill."|baseline, 8 weeks|The analysis population was “Per Protocol” (PP).||scores on a scale||Standard Deviation|Mean
790918|NCT00883493|Secondary|Change in Hamilton Rating Scale for Anxiety (HAM-A) Total Score|"The mean change in HAM-A total score from baseline to final assessment was calculated by subtracting the HAM-A Total score assessed at week 8 from the total score assessed at the baseline (baseline - week 8).
The HAM-A is a 14-item scale that assesses anxiety symptoms of anxiety such as “anxious mood”, “tension” or “fears”. Each item is scored on a 5-point scale, ranging from 0=not present to 4=severe. Sum the scores from all 14 parameters gives the HAM-A Total Score which may range from 0 (min) to 56 (max)."|baseline, 8 weeks|"The analysis population was Per Protocol (PP)."||scores on a scale||Standard Deviation|Mean
790919|NCT00883493|Secondary|Hamilton Rating Scale for Depression (HAM-D) Total Score.|"The mean change of HAM-D Total Score from baseline to the end of treatment was calculated by subtracting the HAM-D Total Score assessed at week 8 from the baseline one (Baseline - week 8).
HAM-D is a multiple choice questionnaire used to rate the severity of a patient's major depression. It consists of 17 different items with possible scores from 0 to 4 or 0 to 2 or 0 to 6 depending on the items. Sum the total of all seventeen items gives the HAM-D Total Score, which may range from 0 (min) to 53 (max). The higher the score, the more severe the depression."|Baseline, 8 Weeks|"The analysis population was Per Protocol (PP)."||scores on a scale||Standard Deviation|Mean
790920|NCT00883493|Secondary|Response Rate for MADRS.|"Response rate defined as the percentage of patients with a ≥50% reduction from baseline in the MADRS total score to the final assessment at week 8.
The MADRS is a 10-item scale that evaluates the core symptoms and cognitive features of clinical depression. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms."|baseline, week 8|The analysis population was “Per Protocol” (PP).This population included all randomized patients, classified according to medication actually received, who took study medication with not less than 75% compliance and who had a randomisation MADRS assessment and all post-randomisation MADRS assessments within pre-defined time windows at each visit.||percentage of participants|||Number
790921|NCT00883493|Primary|Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score.|"The change of MADRS Total Score from baseline to the end of treatment was calculated by subtracting the MADRS Total Score assessed at week 8 from the baseline one (Baseline - 8 weeks).
The MADRS is a 10-item scale that evaluates the core symptoms and cognitive features of clinical depression. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms."|Baseline, 8 weeks|The analysis population was “Per Protocol” (PP).This population included all randomized patients, classified according to medication actually received, who took study medication with not less than 75% compliance and who had a randomisation MADRS assessment and all post-randomisation MADRS assessments within pre-defined time windows at each visit.||scores on a scale||Standard Deviation|Mean
790922|NCT00883558|Secondary|Number of Participants With Hypoglycemic Events|The number of participants with at least one hypoglycemic event (HE) reported during the entire study is presented. Additionally, the number of participants with severe HEs (those that necessitated administration of carbohydrate or glucagon, or resuscitation, by another person) is also presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through Week 29|Participants who received at least 1 dose of study drug.||participants|||Number
790923|NCT00883558|Secondary|Time Spent With Blood Glucose Value Outside a 71-139 Milligrams Per Deciliter (mg/dL) Range During Continuous Glucose Monitoring|Participants were provided a continuous glucose monitoring (CGM) device, consisting of a sensor, transmitter, and receiver. Total time the participant's blood glucose was outside the 71-139 mg/dL range during 3 days of CGM during each treatment cycle (3 days during Week 14 of the first treatment cycle and 3 days during Week 26 of the second treatment cycle) is presented.|Week 14 and Week 26|Participants that completed both treatment cycles with evaluable CGM data.||hours||Standard Deviation|Mean
790924|NCT00883558|Primary|Postprandial Glucose Excursion|A 2-hour postprandial glucose excursion was measured for 3 meals over 3 days during each treatment cycle (3 days during Week 14 of the first treatment cycle and 3 days during Week 26 of the second treatment cycle). For each of the 3 days, the mealtime (breakfast, lunch, and dinner) excursions were calculated as the post-meal glucose value minus the pre-meal value as determined by 8-point glucose monitoring. The average of all excursions over the 3 days for the corresponding treatment cycle is presented.|Week 14 and Week 26|Participants who completed both treatment cycles with evaluable postprandial glucose data.||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
790925|NCT00883675|Primary|Febrile Neutropenia|The primary endpoint of the study was safety, as reflected by a febrile neutropenia rate of <10%.|2 months|Intent to treat||participants|||Number
790926|NCT00883740|Secondary|Subjective Total Sleep Time (sTST)|sTST as reported on daily SSQ, a participant reported subjective estimate of the total amount of time the participant was asleep after lights out until final awakening. Weekly values were calculated as the average of the participants daily SSQ values.|Weeks 1, 2, 3 and 4 of Each Intervention Period or ET|ITT; LOCF||Minutes||Standard Error|Least Squares Mean
790927|NCT00883740|Secondary|Subjective Wake After Sleep Onset (sWASO)|sWASO as reported on daily SSQ, a participant reported subjective estimate of the total amount of time the participant was awake after initial sleep onset until final awakening. Weekly values were calculated as the average of the participant’s daily SSQ values.|Weeks 1, 2, 3 and 4 of Each Intervention Period or ET|ITT; LOCF||Minutes||Standard Error|Least Squares Mean
790928|NCT00883740|Secondary|Daily Pain Score|Pain intensity as measured by NRS; a participant rated scale 0 to 10 (0 = no pain to 10 = worst pain possible). Weekly values were calculated as the average of the participants daily pain scores.|Daily up to Day 73 or ET|ITT; LOCF||Units on a scale||Standard Error|Least Squares Mean
790929|NCT00883740|Secondary|Latency of Sleep Onset (LSO)|LSO as reported on daily Subjective Sleep Questionnaire (SSQ), a participant reported subjective estimate of the amount of time to fall asleep after lights out. Weekly values were calculated as the average minutes reported on the participant’s daily SSQ.|Weeks 1, 2, 3 and 4 of Each Intervention Period or ET|ITT; LOCF||Minutes||Standard Error|Least Squares Mean
790930|NCT00883740|Secondary|Sleep Quality|Sleep Quality as meassured by numeric rating scale (NRS), a participant rated scale 0 to 10, (0 = very poor sleep, 10 = excellent sleep). Weekly values were calculated as the average of the participants daily diary scores.|Weeks 1, 2, 3 and 4 of Each Intervention Period or ET|ITT; Last observation carried forward (LOCF)||Unit on a scale||Standard Error|Least Squares Mean
790931|NCT00883740|Secondary|Change From Baseline in MOS-SS Sleep Problems Index II Weeks 5 and 11|MOS-SS, a participant rated instrument used to assess sleep quantity and quality over the previous week, was compromised of 12 items yielding 7 subscale scores and 2 index composite index scores. Composite index included Sleep Problems Index II (9 items), scores ranged from 0 to 100; higher scores indicated greater sleep problems. Change was score at week x minus score at baseline.|Week 1 (Baseline Intervention Period 1), Week 5 (End of Intervention Period 1), Week 7 (Baseline Intervention Period 2) and Week 11 (End of Intervention Period 2) or ET|ITT||Units on a scale||Standard Error|Least Squares Mean
790932|NCT00883740|Secondary|Change From Baseline in MOS-SS Sleep Disturbance at Weeks 5 and 11|MOS-SS, a participant rated instrument used to assess sleep quantity and quality over the previous week, was comprised of 12 items yielding 7 subscale scores and 2 index composite index scores. Sleep Disturbance subscale score (4 items): individual scores were transformed (actual raw score minus lowest possible score divided by possible raw score range times 100) and ranged from 0 to 100; higher score indicated greater disturbance. Total score ranged=0 to 100; higher score indicates greater intensity of attribute. Change was score at week x minus score at baseline.|Week 1 (Baseline Intervention Period 1), Week 5 (End of Intervention Period 1), Week 7 (Baseline Intervention Period 2) and Week 11 (End of Intervention Period 2) or ET|ITT; n: number of participants at specific time points||Units on a scale||Standard Error|Least Squares Mean
790933|NCT00883740|Secondary|Slow Wave Sleep (SWS)|SWS, as determined by PSG, Stage 3 plus 4 sleep divided by TST times 100 was the percentage of TST. The sum of 2 consecutive nights of recording divided by 2 at the end of each intervention period.|Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET|ITT||Percentage of total sleep time||Standard Error|Least Squares Mean
790934|NCT00883740|Secondary|WASO by Each Quarter of the Night|WASO, as determined by PSG, was the sum of wake time during sleep (number of wake epochs after the onset of persistent sleep and prior to final awakening) and wake time after sleep (the number of epochs after the final awakening until the end of PSG recording) on 2 consecutive nights divided by 2 at the end of each intervention period by each individual quarter of the night (eight hours in 2 hour increments).|Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET|ITT||Minutes||Standard Error|Least Squares Mean
790935|NCT00883740|Secondary|WASO by Hour of the Night|WASO, as determined by PSG, was the wake time during sleep (number of wake epochs after the onset of persistent sleep and prior to final awakening) and wake time after sleep (the number of epochs after the final awakening until the end of PSG recording) on 2 consecutive nights divided by 2 at the end of each intervention period by each individual hour (8 hours total).|Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET|ITT||Minutes||Standard Error|Least Squares Mean
790936|NCT00883740|Secondary|Latency to Persistent Sleep (LPS)|LPS, as determined by PSG, was the total number of epochs recorded on 2 consecutive nights divided by 2 at the end of each intervention period, from the beginning of the recording to the start of the first 20 consecutive non-wake epochs.|Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET|ITT||Minutes||Standard Error|Least Squares Mean
790937|NCT00883740|Secondary|Number of Awakenings After Sleep Onset (NAASO 2)|NAASO 2, as determined by PSG, was the number of times that there was a wake period of at least two epochs in duration. Each entry counted was separated by a Stage 2 epoch, Stage 3 and 4 epoch, or Stage REM epoch. The sum of 2 consecutive nights of recording divided by 2 at the end of each intervention period.|Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET|ITT||Awakenings||Standard Error|Least Squares Mean
790938|NCT00883740|Secondary|Number of Awakenings After Sleep Onset (NAASO 1)|NAASO 1, as determined by PSG, was the number of times there was a wake period of at least one epoch in duration. Each entry counted was separated by a Stage 2 epoch, Stage 3 and 4 epoch, or Stage rapid eye movement (REM) epoch. The sum of 2 consecutive nights of recording was divided by 2 at the end of each intervention period.|Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET|ITT||Awakenings||Standard Error|Least Squares Mean
790939|NCT00883740|Secondary|Sleep Efficiency (SE)|SE, as determined by PSG, was the TST divided by the time in bed, multiplied by 100. The sum of 2 consecutive nights of recording divided by 2 at the end of each intervention period.|Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET|ITT||Percentage of time asleep||Standard Error|Least Squares Mean
790940|NCT00883740|Secondary|Total Sleep Time (TST)|TST, as determined by PSG, was the number of non-wake epochs from the beginning of recording to the end of the recording. TST was the sum of 2 consecutive nights of recording divided by 2 at the end of each intervention period.|Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET|ITT||Minutes||Standard Error|Least Squares Mean
790941|NCT00883740|Secondary|Wake Time After Sleep (WTAS)|WTAS, as determined by PSG, was the total amount of time awake after the final awakening until the end of the 8 hours. WTAS was the sum of 2 consecutive nights of recordings divided by 2 at the end of each intervention period.|Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET|ITT||Minutes||Standard Error|Least Squares Mean
790942|NCT00883740|Secondary|Wake Time During Sleep (WTDS)|WTDS, as determined by PSG, was the total amount of time awake the participant experienced after the onset of persistent sleep and prior to the final awakening, or at the end of 8 hours of recording. WTDS was the sum of 2 consecutive nights of recordings divided by 2 at the end of each intervention period.|Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET|Intent to treat (ITT) population: randomized participants who received at least one dose of medication and had at least one efficacy evaluation||Minutes||Standard Error|Least Squares Mean
790943|NCT00883740|Primary|Wake After Sleep Onset (WASO) at Weeks 5 and 11|WASO was the sum of wake time during sleep measured in epochs (30 seconds of polysomnography [PSG]) recording) after the onset of persistent sleep and prior to final awakening and wake time after sleep (the number of epochs after the final awakening until the end of PSG recording [i.e. awake epoch immediately prior to the end of the recording]) on 2 consecutive nights divided by 2 at the end of each intervention period.|Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or Early Termination (ET)|Per Protocol Population (PP) = all randomized participants who received study medication at a dose of 300 or 450 mg/day and completed the study without any major protocol violations;||Minutes||Standard Error|Least Squares Mean
790956|NCT00883753|Secondary|Change From Baseline in Physician Global Assessment of Disease Activity VAS|"The physician global assessment of disease activity was assessed using a 0 to 100 mm horizontal visual analogue scale (VAS) by the physician. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). A negative change from Baseline indicated improvement."|Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at both Baseline and the given time-point."||mm||Standard Deviation|Mean
790944|NCT00883753|Secondary|Change From Baseline in FACIT-Fatigue Score|FACIT-F is a 13-item questionnaire. Patients scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the patient's response to the questions (with the exception of 2 negatively stated), the greater the patient's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the patient's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the patient's health status. A positive change from Baseline indicated improvement.|Core Baseline, Extension Weeks 12, 24, 36 ,48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available for both Baseline and at the given time-point."||score on a scale||Standard Deviation|Mean
790945|NCT00883753|Secondary|Change From Baseline in Quality of Life Short Form (SF-36):Mental Component Score|The SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from Baseline indicated improvement.|Core Baseline, Extension Weeks 12, 24, 36 ,48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available for both Baseline and at the given time-point."||score on a scale||Standard Deviation|Mean
790946|NCT00883753|Secondary|Change From Baseline in Quality of Life Short Form (SF-36): Physical Component Score|The SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from Baseline indicated improvement.|Core Baseline, Extension Weeks 12, 24, 36 ,48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at both Baseline and the given time-point."||score on a scale||Standard Deviation|Mean
790947|NCT00883753|Secondary|Percentage of Participants Achieving Health Assessment Questionnaire Disability Index (HAQ-DI) Clinical Remission|The Stanford Health Assessment Questionnaire Disability Index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis, consisting of 20 questions in 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. There are 4 possible responses for each question: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty and 3=unable to do. The score for each of the domains is the highest (worst) score in each domain. A patient must have a domain score for at least 6 of 8 domains to calculate a valid HAQ-DI score which is the sum of domain scores, divided by the number of domains that have a score for a total possible score minimum/maximum 0 (best) to 3 (worst). Clinical Remission is defined as a HAQ-DI score < 0.5.|Extension Weeks 12, 24, 36 ,48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at the given time-point."||percentage of participants|||Number
790948|NCT00883753|Secondary|Percentage of Participants Achieving Clinical Meaningful Health Assessment Questionnaire Disability Index (HAQ-DI) Response|The Stanford Health Assessment Questionnaire Disability Index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis, consisting of 20 questions in 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. There are 4 possible responses for each question: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty and 3=unable to do. The score for each of the domains is the highest (worst) score in each domain. A patient must have a domain score for at least 6 of 8 domains to calculate a valid HAQ-DI score which is the sum of domain scores, divided by the number of domains that have a score for a total possible score minimum/maximum 0 (best) to 3 (worst). Clinically meaningful improvement is defined as a reduction from Baseline in the HAQ-DI score ≥ 0.2.|Core Baseline, Extension Weeks 12, 24, 36 ,48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at the given time-point."||percentage of participants|||Number
790949|NCT00883753|Secondary|Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Response|The Stanford Health Assessment Questionnaire Disability Index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis, consisting of 20 questions in 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. There are 4 possible responses for each question: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty and 3=unable to do. The score for each of the domains is the highest (worst) score in each domain. A patient must have a domain score for at least 6 of 8 domains to calculate a valid HAQ-DI score which is the sum of domain scores, divided by the number of domains that have a score for a total possible score minimum/maximum 0 (best) to 3 (worst). A negative change from Baseline indicated improvement.|Core Baseline, Extension Weeks 12, 24, 36 ,48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at both Baseline and the given time-point."||score on a scale||Standard Deviation|Mean
790966|NCT00883753|Secondary|Number of Participants Categorized by Worst Value for Total Cholesterol During the Study|Blood samples were collected for Total Cholesterol every 12 weeks and at the follow-up visit in the Extension study and were sent to a central laboratory for analysis. The number of participants categorized by worst value for Total Cholesterol during the study is reported: Low is below central lab reference range, Normal is within the central lab reference range and High is above central lab reference range.|108 Weeks|Participants from the LTE Safety population (all participants who received study drug and had at least one assessment of safety in the long term extension) with data available for analysis.||participants|||Number
790950|NCT00883753|Secondary|Percentage of Participants With American College of Rheumatology 90 (ACR90) Response|ACR90 response is defined as a ≥ 90 % improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].|Core Baseline, Extension Weeks 12, 24, 36 ,48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at both Baseline and the given time-point."||percentage of participants|||Number
790951|NCT00883753|Secondary|Percentage of Participants With American College of Rheumatology 70 (ACR70) Response|ACR70 response is defined as a ≥ 70 % improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].|Core Baseline, Extension Weeks 12, 24, 36 ,48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at both Baseline and the given time-point."||percentage of participants|||Number
790952|NCT00883753|Secondary|Percentage of Participants With American College of Rheumatology 50 (ACR50) Response|ACR50 response is defined as a ≥ 50 % improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].|Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at both Baseline and the given time-point."||percentage of participants|||Number
790953|NCT00883753|Secondary|Percentage of Participants With American College of Rheumatology 20 (ACR20) Response|ACR20 response was defined as a ≥ 20 % improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].|Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at both Baseline and the given time-point."||percentage of participants|||Number
790954|NCT00883753|Secondary|Change From Baseline in C-Reactive Protein (CRP)|Blood was collected for C-Reactive Protein (CRP) (a test for analysis of inflammatory and infectious disorders) and was analyzed at a central laboratory. The serum concentration of CRP was measured in milligrams/deciliter (mg/dL). A reduction in the level is considered an improvement.|Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at Baseline and the given time-point."||mg/dL||Standard Deviation|Mean
790955|NCT00883753|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR)|Blood was collected for Erythrocyte Sedimentation Rate (ESR) (a test that assesses tissue inflammation) and was analyzed at a local laboratory. ESR was measured in millimeters/hour (mm/hr). A reduction in the level is considered an improvement.|Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at Baseline and the given time-point."||mm/hr||Standard Deviation|Mean
790967|NCT00883753|Secondary|Number of Participants Categorized by Worst Value for LDL Cholesterol During the Study|Blood samples were collected for LDL Cholesterol every 12 weeks and at the follow-up visit in the Extension study and were sent to a central laboratory for analysis. The number of participants categorized by the worst value for LDL Cholesterol during the study is reported: Low is below central lab reference range, Normal is within the central lab reference range and High is above central lab reference range.|108 Weeks|Participants from the LTE Safety population (all participants who received study drug and had at least one assessment of safety in the long term extension) with data available for analysis.||participants|||Number
790957|NCT00883753|Secondary|Change From Baseline in Patient Global Assessment of Disease Activity VAS|"The patients global assessment of disease activity was assessed on a 0 to 100 millimeter (mm) horizontal visual analogue scale (VAS) by the patient. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). A negative change from Baseline indicated improvement."|Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at both Baseline and the given time-point."||score on a scale||Standard Deviation|Mean
790958|NCT00883753|Secondary|Change From Baseline in Patient Assessment of Pain Visual Analog Scale (VAS)|"The patient assessed their pain using a 0 to 100 millimeter (mm) horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 mm, and is described as no pain and the right-hand extreme equals 100 mm as unbearable pain. A negative change from Baseline indicated improvement."|Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at both Baseline and the given time-point."||mm||Standard Deviation|Mean
790959|NCT00883753|Secondary|Change From Baseline in Swollen Joint Count|66 joints were assessed for swelling and joints were classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66. A negative change from Baseline indicated improvement.|Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at both Baseline and the given time-point."||joint count||Standard Deviation|Mean
790960|NCT00883753|Secondary|Change From Baseline in Tender Joint Count|68 joints were assessed for tenderness and joints were classified as tender/not tender giving a total possible tender joint count score of 0 to 68. A negative change from Baseline indicated improvement.|Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at both Baseline and the given time-point."||joint count||Standard Deviation|Mean
790961|NCT00883753|Secondary|Change From Baseline in DAS28|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement.|Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at both Baseline and the given time-point."||score on a scale||Standard Deviation|Mean
790962|NCT00883753|Secondary|Percentage of Participants With DAS28 Remission|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission was defined as a DAS28 score < 2.6.|Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at the given time-point."||percentage of participants|||Number
790963|NCT00883753|Secondary|Percentage of Participants With DAS28 Low Disease Activity|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. Low Disease Activity was defined as a score of < 3.2.|Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at the given time-point."||percentage of participants|||Number
790964|NCT00883753|Secondary|Percentage of Participants With Clinically Meaningful Improvement in Disease Activity Score-28 (DAS28)|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. Clinical meaningful improvement was defined as a ≥ 1.2 unit reduction in DAS28.|Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108|"Long Term Extension Intent-to-treat (LTE ITT) population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available for both Baseline and the given time-point."||percentage of participants|||Number
790965|NCT00883753|Secondary|Number of Participants Categorized by Worst Value for Neutrophil Count During the Study|Blood samples were collected for a Neutrophil Count every 12 weeks and at the follow-up visit in the Extension study and were sent to a central laboratory for analysis. The number of participants categorized by the worst value for Neutrophil Count during the study is reported: Low is below central lab reference range, Normal is within the central lab reference range and High is above central lab reference range.|108 Weeks|Participants from the LTE Safety population (all participants who received study drug and had at least one assessment of safety in the long term extension) with data available for analysis.||participants|||Number
790968|NCT00883753|Secondary|Number of Participants Categorized by Worst Value for AST (SGOT) During the Study|Blood samples were collected for liver function test: Aspartate aminotransferase (serum glutamic-oxaloacetic transaminase) [AST (SGOT)] every 12 weeks and at the follow-up visit in the Extension study and were sent to a central laboratory for analysis. The Upper Limit of Normal (ULN) for AST=40 Units/Liter. The number of participants categorized by worst value for AST(SGOT) during the study is reported: Normal (AST result is within the central lab reference range), Greater than the ULN to 1.5 times the ULN (>ULN to 1.5*ULN), 1.5 times the ULN to 3 times the ULN (1.5*ULN to 3*ULN) and 3 times the ULN to 5 times the ULN (3*ULN to 5*ULN).|108 Weeks|Participants from the LTE Safety population included all participants who received study drug and had at least one assessment of safety in the long term extension (LTE) with data available for analysis.||participants|||Number
790969|NCT00883753|Secondary|Number of Participants Categorized by Highest Value for ALT (SGPT) During the Study|Blood samples were collected for liver function test: Alanine aminotransferase (serum glutamic-pyruvic transaminase) [ALT(SGPT)] every 12 weeks and at the follow-up visit in the Extension study and were sent to a central laboratory for analysis. The Upper Limit of Normal (ULN) for ALT=55 Units/Liter. The number of participants categorized by the highest value for ALT/GPT during the study is reported: Normal (ALT result within the central lab reference range), Greater than the ULN to 1.5 times the ULN (>ULN to 1.5*ULN), 1.5 times the ULN to 3 times the ULN (1.5*ULN to 3*ULN) and 3 times the ULN to 5 times the ULN (3*ULN to 5*ULN).|108 Weeks|Participants from the LTE Safety population included all participants who received study drug and had at least one assessment of safety in the long term extension (LTE) with data available for analysis.||participants|||Number
790970|NCT00883753|Secondary|Percentage of Participants With AST Elevations > 3*ULN|Blood was collected for the Liver Function Test: Aspartate aminotransferase (AST) every 12 weeks and at the follow-up visit in the Extension study and were sent to a central laboratory for analysis. Percentage of participants with any values greater than 3 times the Upper Limit of Normal (3*ULN) is reported. ULN= 40 Units/Liter.|108 Weeks|LTE Safety population included all participants who received study drug and had at least one assessment of safety in the long term extension (LTE).||percentage of participants|||Number
790971|NCT00883753|Secondary|Percentage of Participants With ALT Elevations > 3*ULN|Blood samples were collected for the Liver Function Test: Alanine aminotransferase (ALT) every 12 weeks and at the follow-up visit in the Extension study and were sent to a central laboratory for analysis. Percentage of participants with any values greater than 3 times the Upper Limit of Normal (3*ULN) is reported. ULN= 55 Units/Liter.|108 Weeks|LTE Safety population included all participants who received study drug and had at least one assessment of safety in the long term extension (LTE).||percentage of participants|||Number
790972|NCT00883753|Secondary|Percentage of Participants With Adverse Events (AEs) of Special Interest|An Adverse Event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events. Adverse Events of special interest for this study were: Infections (preferred term in the infection adverse event group term), Serious Infections (an infection that qualified as Serious Adverse Event), Infusion Reactions (occurred during infusion or within 24 hours of infusion), Major Cardiac AE (Myocardial Infarction/ Acute Coronary Syndrome), Stroke or Death.|108 Weeks|LTE Safety population included all participants who received study drug and had at least one assessment of safety in the long term extension (LTE).||percentage of participants|||Number
790973|NCT00883753|Secondary|Percentage of Participants With Marked Lipid Abnormalities|Fasting blood samples were collected for Lipids: Cholesterol, Triglyceride, High-density lipoprotein (HDL) Cholesterol, Low-density lipoprotein (LDL) Cholesterol every 12 weeks and at follow-up in the Extension study and were sent to a central laboratory for analysis. Lipid abnormalities were defined as a High Cholesterol, High Triglyceride, Low HDL Cholesterol and a High LDL Cholesterol that occurred at any time in the extension study.|108 Weeks|LTE Safety population included all participants who received study drug and had at least one assessment of safety in the long term extension (LTE).||percentage of participants|||Number
790974|NCT00883753|Secondary|Time to Discontinuation of Tocilizumab Treatment for Any Cause|Time in days from start of the Core Study Day 1 to discontinuation of tocilizumab for any reason.|108 Weeks|LTE Safety population included all participants who received study drug and had at least one assessment of safety in the long term extension (LTE). Participants who did not experience discontinuation of tocilizumab treatment were censored.||days||95% Confidence Interval|Median
790975|NCT00883753|Secondary|Percentage of Participants With Discontinuation of Treatment Due to Any Cause|Percentage of participants who discontinued treatment with tocilizumab for any reason.|108 Weeks|LTE Safety population included all participants who received study drug and had at least one assessment of safety in the long term extension (LTE).||percentage of participants|||Number
790976|NCT00883753|Secondary|Time to Withdrawal Due to an Adverse Event (AE)|Time to withdrawal was defined as the number of days from Core Study Day 1 to the first date of onset of the AE leading to discontinuation of tocilizumab.|108 Weeks|LTE Safety population included all participants who received study drug and had at least one assessment of safety in the long term extension(LTE). Participants who did not experience an AE-related treatment discontinuation of tocilizumab were censored.||days||95% Confidence Interval|Median
790977|NCT00883753|Secondary|Percentage of Participants With Adverse Events Leading to Withdraw|An Adverse Event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events.|108 Weeks|LTE Safety population included all participants who received study drug and had at least one assessment of safety in the long term extension (LTE).||percentage of participants|||Number
790993|NCT00883779|Secondary|Percentage of Participants Alive and Free From Disease Progression|Tumor response was evaluated according to RECIST (version 1.0). PD was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.|Randomization until PD or death (assessed at baseline and every 8 weeks thereafter until PD, death or end of study [up to approximately 1.5 years])|FAS population.||percentage of participants|||Number
790978|NCT00883753|Primary|Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events. A SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant. The percentage of participants with AEs and SAEs that occurred in the Extension Study grouped according to the number of disease-modifying anti-rheumatic drugs (DMARD) a participant was taking at Core Baseline is presented.|108 Weeks|LTE Safety population included all participants who received study drug and had at least one assessment of safety in the long term extension (LTE).||percentage of participants||95% Confidence Interval|Number
790979|NCT00883779|Secondary|Median Follow-up Time During the Study|Median follow-up was calculated using 'Reverse Kaplan-Meier' analysis for Overall survival.|Randomization until PD or death (assessed at baseline and every 8 weeks thereafter until PD, death or end of study [up to approximately 5.5 years])|FAS population.||months||95% Confidence Interval|Median
790980|NCT00883779|Secondary|Time to Deterioration in QOL Using FACT-L Version 4.0|"Time to deterioration in QoL is defined as time from randomization until the earlier of a clinically meaningful decline from baseline in Total FACT-L or death on study. Total FACT-L score was defined as the sum of the TOI, SWB and EWB of the FACT-L questionnaires. TOI (PWB + FWB + LCS), SWB and EWB scores were obtained from 7-item (6-item in the case of EWB) questionnaires from the FACT-L (Version 4.0). Participants responded to questions on a 5-point scale from 0-4, where 0 = not at all and 4 = very much. The participants' responses were summed to result in an overall score, scores range on a scale of 0 to 136; higher score indicates better QoL. A clinically meaningful decline used to determine deterioration in QoL was ≥6-point decline from baseline. Participants without deterioration in QoL at the time of analysis were censored at the time of the last FACT-L assessment. Analysis was performed using Kaplan-Meier method."|Baseline, Day 1 of Cycles 3 and 5, Day 1 of post-study Visits 1 and 2 until end of study medication administration or PD (up to approximately 1.5 years)|FAS population.||months||95% Confidence Interval|Median
790981|NCT00883779|Secondary|Percentage of Participants With Deterioration in Quality of Life (QOL) Using FACT-L Version 4.0|"Total FACT-L score was defined as the sum of the TOI, Social Well Being (SWB) and EWB of the FACT-L questionnaires. TOI (PWB + FWB + LCS), SWB and EWB scores were obtained from 7-item (6-item in the case of EWB) questionnaires from the FACT-L (Version 4.0). Participants responded to questions on a 5-point scale from 0-4, where 0 = not at all and 4 = very much. The participants' responses were summed to result in an overall score, scores range on a scale of 0 to 136; higher score indicates better QoL. A clinically meaningful decline used to determine deterioration in QoL was ≥6-point decline from baseline. Participants without deterioration in QoL at the time of analysis were censored at the time of the last FACT-L assessment."|Baseline, Day 1 of Cycles 3 and 5, Day 1 of post-study Visits 1 and 2 until end of study medication administration or PD (up to approximately 1.5 years)|FAS population.||percentage of participants|||Number
790982|NCT00883779|Secondary|Time to Deterioration in TOI Using FACT-L Version 4.0|"Time to deterioration in TOI is defined as time from randomization until the earlier of a clinically meaningful decline from baseline in TOI or death on study. TOI is defined as the sum of the scores of the PWB, FWB, and LCS. PWB, FWB, and LCS scores were obtained from 7-item questionnaires from the FACT-L (Version 4.0). Participants responded to questions on a 5-point scale from 0-4, where 0 = not at all and 4 = very much. The participants' responses were summed to result in an overall score, scores range on a scale of 0 to 84; higher score indicates better physical aspects of QoL. A clinically meaningful decline used to determine deterioration in TOI was ≥6-point decline from baseline. Participants without deterioration in TOI at the time of analysis were censored at the time of the last FACT-L assessment. Analysis was performed using Kaplan-Meier method."|Baseline, Day 1 of Cycles 3 and 5, Day 1 of post-study Visits 1 and 2 until end of study medication administration or PD (up to approximately 1.5 years)|FAS population.||months||95% Confidence Interval|Median
790983|NCT00883779|Secondary|Percentage of Participants With Deterioration in Trial Outcome Index (TOI) Using FACT-L Version 4.0|"TOI was defined as the sum of the scores of the Physical Well-Being (PWB), Functional Well-Being (FWB), and LCS. PWB, FWB, and LCS scores were obtained from 7-item questionnaires from the FACT-L (Version 4.0). Participants responded to questions on a 5-point scale from 0-4, where 0 = not at all and 4 = very much. The participants' responses were summed to result in an overall score, scores range on a scale of 0 to 84; higher score indicates better physical aspects of quality of life (QoL). A clinically meaningful decline used to determine deterioration in TOI was greater than or equal to (≥) 6-point decline from baseline. Participants without deterioration in TOI at the time of analysis were censored at the time of the last FACT-L assessment."|Baseline, Day 1 of Cycles 3 and 5, Day 1 of post-study Visits 1 and 2 until end of study medication administration or PD (up to approximately 1.5 years)|FAS population.||percentage of participants|||Number
790984|NCT00883779|Secondary|Time to Symptomatic Progression|"Time to symptomatic progression was the time from randomization until the earlier of a clinically meaningful decline from baseline in LCS score, or death on study. LCS scores were obtained from a 7-item questionnaire from the FACT-L (version 4.0). Participants responded to questions such as shortness of breath, cough, tightness in chest, breathing difficulty, appetite loss, weight loss and unclear thinking; on a 5-point scale from 0-4, where 0 = not at all and 4 = very much. The participants' responses were summed to result in an overall score, scores range on a scale of 0 (most symptomatic) to 28 (asymptomatic); higher score indicates fewer symptoms. A clinically meaningful decline used to determine symptomatic progression in this study was at least a three point decline in LCS score from baseline. Participants without symptomatic progression at the time of analysis were censored at the time of the last FACT-L assessment. Analysis was performed using Kaplan-Meier method."|Baseline, Day 1 of Cycles 3 and 5, Day 1 of post-study Visits 1 and 2 until end of study medication administration or PD (up to approximately 1.5 years)|FAS population.||months||95% Confidence Interval|Mean
791029|NCT00884221|Secondary|Live Birth for a Single Stimulation Cycle With Single Blastocyst Transfer From Fresh Embryo Replacement Cycle, Intention-to-treat (ITT) Analysis Set||Post-trial information|The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.||Percentage of participants||Standard Deviation|Mean
790985|NCT00883779|Secondary|Percentage of Participants With Symptomatic Progression Assessed Using the Lung Cancer Subscale (LCS)|"LCS scores were obtained from a 7-item questionnaire from the Functional Assessment of Cancer Therapy - Lung (FACT-L) (version 4.0). Participants responded to questions such as shortness of breath, cough, tightness in chest, breathing difficulty, appetite loss, weight loss and unclear thinking; on a 5-point scale from 0-4, where 0 equaled (=) not at all and 4 = very much. The participants' responses were summed to result in an overall score, scores range on a scale of 0 (most symptomatic) to 28 (asymptomatic); higher score indicates fewer symptoms. A clinically meaningful decline used to determine symptomatic progression in this study was at least a three point decline in LCS score from baseline. Participants without symptomatic progression at the time of analysis were censored at the time of the last FACT-L assessment."|Baseline, Day 1 of Cycles 3 and 5, Day 1 of post-study Visits 1 and 2 until end of study medication administration or PD (up to approximately 1.5 years)|FAS population.||percentage of participants|||Number
790986|NCT00883779|Secondary|Time to Progression|Time to progression is defined as the time between the date of randomization and the date of the first documented disease progression. Participants who have not progressed at the time of study completion (or data cut off) or who were lost to follow up were censored at the date of the last tumor assessment where non-progression was documented or last date of follow-up for progression of disease, whichever was latest. PD was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions. Participants with no post baseline tumor assessments were censored at the time of randomization. Analysis was performed using Kaplan-Meier method.|Randomization until PD (assessed at baseline and every 8 weeks thereafter until PD or end of study [up to approximately 1.5 years])|FAS population.||months||95% Confidence Interval|Median
790987|NCT00883779|Secondary|Duration of Response|Duration of response is defined as the time between the date of first documented response (CR or PR, as determined by the RECIST criteria) and the date of first documented PD or death. Participants who did not progress or die after they had a confirmed response (CR or PR) were censored at the date of their last tumor assessment where non-progression was documented or last date of follow-up for progression of disease, whichever was last. CR and PR are defined in Outcome Measure 7.|Randomization until PD or death (assessed at baseline and every 8 weeks thereafter until PD, death or end of study [up to approximately 1.5 years])|FAS population participants who were responders (CR or PR).||months||95% Confidence Interval|Median
790988|NCT00883779|Secondary|Objective Response Rate: Percentage of Participants With a Confirmed Best Overall Response of CR or PR|Tumor response was evaluated according to RECIST (version 1.0). CR is defined as the disappearance of all target and non-target lesions and normalization of tumor marker level; PR is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the screening sum LD. Responses were confirmed with repeated assessment 4 weeks after initial response was observed.|Randomization until PD or death (assessed at baseline and every 8 weeks thereafter until PD, death or end of study [up to approximately 1.5 years])|FAS population.||percentage of participants||95% Confidence Interval|Number
790989|NCT00883779|Secondary|Non-Progression Rate: Percentage of Participants With a Confirmed Best Overall Response of Either Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) for At Least 16 Weeks|Tumor response was evaluated according to RECIST (version 1.0). CR is defined as the disappearance of all target and non-target lesions and normalization of tumor marker level; PR is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the screening sum LD; SD for target lesions is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started and SD for non-target lesions defined as persistence of 1 or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. Responses were confirmed with repeated assessment 4 weeks after initial response was observed.|Randomization until PD or death (assessed at baseline and every 8 weeks thereafter until PD, death or end of study [up to approximately 1.5 years])|FAS population.||percentage of participants||95% Confidence Interval|Number
790990|NCT00883779|Secondary|Percentage of Participants Alive at the End of Study-Overall and Among Different Subgroups||Randomization until death (assessed at baseline and every 8 weeks thereafter until death or end of study [up to approximately 5.5 years])|"FAS population. n is the number of participants evaluable under the specified category."||percentage of participants|||Number
790991|NCT00883779|Secondary|Median Overall Survival (OS) Time-Overall and Among Different Subgroups|OS was defined as the time between the date of randomization and the date of death from any cause. Participants for whom no death was captured on the clinical database were censored at the most recent date they were known to be alive. Participants with no post baseline information were censored at the time of randomization. OS among different subgroups of type of carcinoma, smoking habit, EGFR mutation type, KRAS mutation type, EGFR IHC test result type, and EGFR FISH result type. Analysis was performed using Kaplan-Meier method.|Randomization until death (assessed at baseline and every 8 weeks thereafter until death or end of study [up to approximately 5.5 years])|"FAS population. n is the number of participants evaluable under the specified category."||months||95% Confidence Interval|Median
790992|NCT00883779|Secondary|Median PFS Time Based on Different Subgroups|Tumor response was evaluated according to RECIST (version 1.0). PD was defined in outcome measure 1. PFS is the time (in months) between the date of randomization and the date of first documented disease progression or death from any cause, whichever comes first. Participants who had neither progressed nor died at the time of data cut-off or who were lost to follow-up were censored at the date of the last tumor assessment where non-progression was documented or last date of follow up for progression of disease, whichever was last. Participants without post baseline tumor assessments who were known to be alive were censored at the time of randomization. PFS among different subgroups of type of carcinoma, smoking habit, epidermal growth factor receptor (EGFR) mutation type, KRAS mutation type, EGFR immunohistochemistry (IHC) test result type, and EGFR fluorescent in situ hybridization (FISH) result type.|Randomization until PD or death (assessed at baseline and every 8 weeks thereafter until PD, death or end of study [up to approximately 1.5 years])|"FAS population. n is the number of participants evaluable under the specified category."||months||95% Confidence Interval|Median
791218|NCT00875433|Secondary|Maximum Concentration (Cmax)|Cmax represents the maximum measured concentration of afatinib in plasma on Day 1.|0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 1|TS.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
790994|NCT00883779|Primary|Median Progression Free Survival (PFS) Time|Tumor response was evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). PD was defined as at least a 20 percent (%) increase in the sum of longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions. PFS is the time (in months) between the date of randomization and the date of first documented disease progression or death from any cause, whichever comes first. Participants who had neither progressed nor died at the time of data cut-off or who were lost to follow-up were censored at the date of the last tumor assessment where non-progression was documented or last date of follow up for progression of disease, whichever was last. Participants without post baseline tumor assessments who were known to be alive were censored at the time of randomization. Analysis was performed using Kaplan-Meier method.|Randomization until PD or death (assessed at baseline and every 8 weeks thereafter until PD, death or end of study [up to approximately 1.5 years])|FAS population.||months||95% Confidence Interval|Median
790995|NCT00884039|Primary|Change in Intraocular Pressure||1 week, 2 weeks, and monthly through 6 months after treatment||||||
790996|NCT00884039|Primary|Intraocular Pressure Within Normal Limits (<24 mm Hg)|Intraocular pressure was measured by Goldmann applanation tonometry.|1 month|Per protocol||Participants|||Number
790997|NCT00884065|Primary|Change in Active Internal Rotation After Intervention Minus Baseline|Change in active internal rotation was measured with the hand behind back test. The position achieved by the tip of the thumb was marked and with a flexible metric tape (always the same) the distance in centimetres between this mark and the inferior tip of the spinous process of C7 was measured; the shorter the distance, the better the mobility|Baseline and the same day (just after intervention)|||Centimeters||Standard Deviation|Mean
790998|NCT00884065|Primary|Change in Active External Rotation After Intervention Minus Baseline|A universal double armed goniometer was used to measure change in active external rotation measured in the neutral position of the shoulder (arm pinned to the trunk), elbow flexed to 90º and the forearm in indifferent pronosupination (thumb forward)|Baseline and the same day (just after intervention)|||Sexagesimal degrees||Standard Deviation|Mean
790999|NCT00884065|Primary|Change in Active extensión Movement After Intervention Minus Baseline|A universal double armed goniometer was used to measure change in active extensión movement in the sagital plane with the elbow fully extended and the forearm in indifferent pronosupination (thumb forward)|Baseline and the same day (just after intervention)|||Sexagesimal degrees||Standard Deviation|Mean
791000|NCT00884065|Primary|Change in Active Abduction Movement After Intervention Minus Baseline|A universal double armed goniometer was used to measure change in active abduction movement in the scapular plane with the elbow in extension and the forearm in supination|Baseline and the same day (just after intervention)|||Sexagesimal degrees||Standard Deviation|Mean
791001|NCT00884065|Primary|Change in Active Flexion Movement After Intervention Minus Baseline|A universal double armed goniometer was used to measure change in active flexión movement in the sagital plane with the elbow fully extended and the forearm in indifferent pronosupination (thumb forward)|Baseline and the same day (just after intervention)|||Sexagesimal Degrees||Standard Deviation|Mean
791002|NCT00884065|Secondary|Change in Pain in the Hand Behind Back Position After Intervention Minus Baseline|An unmarked Visual Analogue Scale from 0 (no pain) to 100 (worst pain) millimeters was used. At baseline, participants registered the pain perceived in the position used to measure the internal rotation. After intervention, they registered the pain with the hand placed in the same position taking as a reference the mark in the first evaluation.|Baseline and the same day (just after intervention)|||Millimeters||Standard Deviation|Mean
791003|NCT00884117|Secondary|Change From Baseline in Body Temperature Among Children Treated With Oseltamivir|Body temperature was measured by the Investigator using an oral or tympanic thermometer at Baseline and Day 10. The change in body temperature between visits was averaged among all participants and expressed in degrees Celsius.|Baseline (Day 1) to Day 10|ALCIP Population. The “Number of Participants Analyzed” reflects the total number of participants who provided evaluable data for their viral RNA subtype at Baseline and Day 10. The number of participants who provided evaluable data for each viral RNA subtype at Baseline and Day 10 (n) is shown in the table.||degrees Celsius||Standard Deviation|Mean
791004|NCT00884117|Secondary|Body Temperature Among Children Treated With Oseltamivir|Body temperature was measured by the Investigator using an oral or tympanic thermometer at Baseline and Day 10. Body temperature at each visit was averaged among all participants and expressed in degrees Celsius.|Days 1, 10|"ALCIP Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for their viral RNA subtype at the specified visit. The number of participants who provided evaluable data for each viral RNA subtype at the specified visit (n) is shown in the table."||degrees Celsius||Standard Deviation|Mean
791005|NCT00884117|Secondary|Change From Baseline in Body Temperature Among Adults Treated With Oseltamivir|Body temperature was measured by the Investigator using an oral or tympanic thermometer at Baseline and Day 10. The change in body temperature between visits was averaged among all participants and expressed in degrees Celsius.|Baseline (Day 1) to Day 10|ALCIP Population. The “Number of Participants Analyzed” reflects the total number of participants who provided evaluable data for their viral RNA subtype at Baseline and Day 10. The number of participants who provided evaluable data for each viral RNA subtype at Baseline and Day 10 (n) is shown in the table.||degrees Celsius||Standard Deviation|Mean
791006|NCT00884117|Secondary|Body Temperature Among Adults Treated With Oseltamivir|Body temperature was measured by the Investigator using an oral or tympanic thermometer at Baseline and Day 10. Body temperature at each visit was averaged among all participants and expressed in degrees Celsius.|Days 1, 10|ALCIP Population. The “Number of Participants Analyzed” reflects the total number of participants who provided evaluable data for their viral RNA subtype at the specified visit. The number of participants who provided evaluable data for each viral RNA subtype at the specified visit (n) is shown in the table.||degrees Celsius||Standard Deviation|Mean
791043|NCT00884221|Primary|Ongoing Pregnancy After One Fresh Embryo Replacement Cycle, Intention-to-treat (ITT) Analysis Set|Transvaginal ultrasound showing at least one intrauterine viable fetus 10-11 weeks after embryo transfer at the blastocyst stage|10-11 weeks after embryo transfer at the blastocyst stage|The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.||Percentage of participants||Standard Deviation|Mean
791007|NCT00884117|Secondary|Total Daily Symptom Score According to Global Assessment by the Investigator Among Children Treated With Oseltamivir|Symptoms were assessed on Days 1, 6, and 10. The Investigator rated seven symptoms of fever, sore throat, nasal congestion, cough, aches/pains, headache, and energy/tiredness on a scale of 0 (absent/no problem) to 3 (severe/major problem). The global score was calculated as a sum of all individual symptom scores. Global scores may range from 0 to 21, with higher scores indicating worse or more pronounced symptoms.|Days 1, 6, 10|ALCIP Population. The “Number of Participants Analyzed” reflects the total number of participants who provided evaluable data for their viral RNA subtype at the specified visit. The number of participants who provided evaluable data for each viral RNA subtype at the specified visit (n) is shown in the table.||units on a scale||Standard Deviation|Mean
791008|NCT00884117|Secondary|Total Daily Symptom Score According to Global Assessment by the Investigator Among Adults Treated With Oseltamivir|Symptoms were assessed on Days 1, 6, and 10. The Investigator rated seven symptoms of fever, sore throat, nasal congestion, cough, aches/pains, headache, and fatigue on a scale of 0 (absent/no problem) to 3 (severe/major problem). The global score was calculated as a sum of all individual symptom scores. Global scores may range from 0 to 21, with higher scores indicating worse or more pronounced symptoms.|Days 1, 6, 10|ALCIP Population. The “Number of Participants Analyzed” reflects the total number of participants who provided evaluable data for their viral RNA subtype at the specified visit. The number of participants who provided evaluable data for each viral RNA subtype at the specified visit (n) is shown in the table.||units on a scale||Standard Deviation|Mean
791009|NCT00884117|Secondary|Percentage of Participants With Resistant Versus Susceptible Viruses by Baseline Viral Load|Pre-defined mutations in viral RNA were noted, the presence of which was defined as genotypic resistance. Phenotypic resistance was defined as IC50 more than 10-fold higher than the median value for all viruses of the same subtype. Treatment-emergent resistance was defined as the presence of genotypic or phenotypic resistance from a post-Baseline sample in the setting of a previously non-resistant Baseline sample. Susceptible viruses were those that did not exhibit treatment-emergent resistance. The mean viral load from each sample was expressed in log10 vp/mL and stratified by resistant and susceptible viruses.|Baseline (Day 1)|ALCIP Population. The “Number of Participants Analyzed” reflects the total number of participants with wild-type infection status at Baseline who provided evaluable data. The number of participants who provided evaluable data for each resistance status at Baseline (n) is shown in the table.||percentage of participants|||Number
791010|NCT00884117|Secondary|Percentage of Participants by Day of Viral RNA First Not Detected Comparing Resistant and Susceptible Viruses|Pre-defined mutations in viral RNA were noted, the presence of which was defined as genotypic resistance. Phenotypic resistance was defined as IC50 more than 10-fold higher than the median value for all viruses of the same subtype. Treatment-emergent resistance was defined as the presence of genotypic or phenotypic resistance from a post-Baseline sample in the setting of a previously non-resistant Baseline sample. Susceptible viruses were those that did not exhibit treatment-emergent resistance. The percentage of participants by earliest post-Baseline test day on which viral RNA was not detected was reported and stratified by resistant and susceptible viruses.|Days 3, 6, 10|ALCIP Population. The “Number of Participants Analyzed” reflects the total number of participants with wild-type infection status at Baseline who provided evaluable data at the specified visit. The number of participants who provided evaluable data for each resistance status at the specified visit (n) is shown in the table.||percentage of participants|||Number
791011|NCT00884117|Secondary|Percentage of Participants With Symptom Resolution on Day 6 Comparing Resistant and Susceptible Viruses|Pre-defined mutations in viral RNA were noted, the presence of which was defined as genotypic resistance. Phenotypic resistance was defined as 50% inhibitory concentration (IC50) more than 10-fold higher than the median value for all viruses of the same subtype. Treatment-emergent resistance was defined as the presence of genotypic or phenotypic resistance from a post-Baseline sample in the setting of a previously non-resistant Baseline sample. Susceptible viruses were those that did not exhibit treatment-emergent resistance. The percentage of participants with mild or absent symptoms on Day 6 was reported and stratified by resistant and susceptible viruses.|Day 6|ALCIP Population. The “Number of Participants Analyzed” reflects the total number of participants with wild-type infection status at Baseline who provided evaluable data at the Day 6 visit. The number of participants who provided evaluable data for each resistance status at the Day 6 visit (n) is shown in the table.||percentage of participants|||Number
791012|NCT00884117|Secondary|Viral Load Among Children Treated With Oseltamivir|Viral load was determined for those with detectable virus above the LLQ of 1.82 for influenza A viruses and 1.99 for influenza B viruses. The viral load from each sample was averaged among all participants and expressed in log10 vp/mL.|Days 1, 3, 6, 10|ALCIP Population. The “Number of Participants Analyzed” reflects the highest total number of participants who provided evaluable data for their viral RNA subtype at any visit. The number of participants who provided evaluable data for each viral RNA subtype at the specified visit (n) is shown in the table.||log10 vp/mL||Standard Deviation|Mean
791013|NCT00884117|Secondary|Viral Load Among Adults Treated With Oseltamivir|Viral load was determined for those with detectable virus above the lower limit of quantification (LLQ) of 1.82 for influenza A viruses and 1.99 for influenza B viruses. The viral load from each sample was averaged among all participants and expressed in log10 of the number of viral particles per milliliter (log10 vp/mL).|Days 1, 3, 6, 10|ALCIP Population. The “Number of Participants Analyzed” reflects the highest total number of participants who provided evaluable data for their viral RNA subtype at any visit. The number of participants who provided evaluable data for each viral RNA subtype at the specified visit (n) is shown in the table.||log10 vp/mL||Standard Deviation|Mean
791014|NCT00884117|Secondary|Time to Non-Detection of Viral RNA Among Participants With Influenza B Infections|Time to non-detection/viral clearance was the time between symptom onset and the day on which viral RNA was no longer detected, or the last visit date if the participant was not RNA-negative at that visit. Time to non-detection/viral clearance was estimated using Kaplan-Meier analysis and expressed in days.|From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10)|ALCIP Population. The “Number of Participants Analyzed” reflects the number of participants with influenza B infection who provided sufficient post-Baseline data.||days||95% Confidence Interval|Median
791044|NCT00884273|Primary|Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Per Protocol Analysis Set)|TRUS is a method of measuring the size of the prostate.|After treatment of 12 weeks compared to Baseline|Per Protocol (PP) Analysis Set, Last Observation Carried Forward (LOCF).||milliliter||Standard Deviation|Mean
791016|NCT00884117|Secondary|Time to Non-Detection of Viral RNA Among Participants With H3N2 Infections|Time to non-detection/viral clearance was the time between symptom onset and the day on which viral RNA was no longer detected, or the last visit date if the participant was not RNA-negative at that visit. Time to non-detection/viral clearance was estimated using Kaplan-Meier analysis and expressed in days.|From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10)|ALCIP Population. The “Number of Participants Analyzed” reflects the number of participants with H3N2 infection who provided sufficient post-Baseline data.||days||95% Confidence Interval|Median
791017|NCT00884117|Secondary|Time to Non-Detection of Viral RNA|Time to non-detection/viral clearance was the time between symptom onset and the day on which viral RNA was no longer detected, or the last visit date if the participant was not RNA-negative at that visit. Time to non-detection/viral clearance was estimated using Kaplan-Meier analysis and expressed in days.|From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10)|ALCIP Population. The “Number of Participants Analyzed” reflects the number of participants who provided sufficient post-Baseline data.||days||95% Confidence Interval|Median
791018|NCT00884117|Secondary|Number of Participants With Viral RNA Detected by RT-PCR on Day 10 Among Children Treated With Oseltamivir||Day 10|ALCIP Population. The “Number of Participants Analyzed” reflects the total number of participants who provided evaluable data for their viral RNA subtype at the Day 10 visit. The number of participants who provided evaluable data for each viral RNA subtype at the Day 10 visit (n) is shown in the table.||participants|||Number
791019|NCT00884117|Secondary|Number of Participants With Viral RNA Detected by RT-PCR on Day 6 Among Children Treated With Oseltamivir||Day 6|ALCIP Population. The “Number of Participants Analyzed” reflects the total number of participants who provided evaluable data for their viral RNA subtype at the Day 6 visit. The number of participants who provided evaluable data for each viral RNA subtype at the Day 6 visit (n) is shown in the table.||participants|||Number
791020|NCT00884117|Secondary|Number of Participants With Viral RNA Detected by RT-PCR on Day 3 Among Children Treated With Oseltamivir||Day 3|ALCIP Population. The “Number of Participants Analyzed” reflects the total number of participants who provided evaluable data for their viral RNA subtype at the Day 3 visit. The number of participants who provided evaluable data for each viral RNA subtype at the Day 3 visit (n) is shown in the table.||participants|||Number
791021|NCT00884117|Secondary|Number of Participants With Viral RNA Detected by RT-PCR on Day 1 Among Children Treated With Oseltamivir||Baseline (Day 1)|ALCIP Population. The “Number of Participants Analyzed” reflects the total number of participants who provided evaluable data for their viral RNA subtype at the Baseline visit.||participants|||Number
791022|NCT00884117|Secondary|Number of Participants With Viral RNA Detected by RT-PCR on Day 10 Among Adults Treated With Oseltamivir||Day 10|ALCIP Population. The “Number of Participants Analyzed” reflects the total number of participants who provided evaluable data for their viral RNA subtype at the Day 10 visit. The number of participants who provided evaluable data for each viral RNA subtype at the Day 10 visit (n) is shown in the table.||participants|||Number
791023|NCT00884117|Secondary|Number of Participants With Viral RNA Detected by RT-PCR on Day 6 Among Adults Treated With Oseltamivir||Day 6|ALCIP Population. The “Number of Participants Analyzed” reflects the total number of participants who provided evaluable data for their viral RNA subtype at the Day 6 visit. The number of participants who provided evaluable data for each viral RNA subtype at the Day 6 visit (n) is shown in the table.||participants|||Number
791024|NCT00884117|Secondary|Number of Participants With Viral RNA Detected by RT-PCR on Day 3 Among Adults Treated With Oseltamivir||Day 3|ALCIP Population. The “Number of Participants Analyzed” reflects the total number of participants who provided evaluable data for their viral RNA subtype at the Day 3 visit. The number of participants who provided evaluable data for each viral RNA subtype at the Day 3 visit (n) is shown in the table.||participants|||Number
791025|NCT00884117|Secondary|Number of Participants With Viral RNA Detected by RT-PCR on Day 1 Among Adults Treated With Oseltamivir||Baseline (Day 1)|ALCIP Population. The “Number of Participants Analyzed” reflects the total number of participants who provided evaluable data for their viral RNA subtype at the Baseline visit.||participants|||Number
791026|NCT00884117|Primary|Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections|Pre-defined mutations in viral RNA were noted, the presence of which was defined as genotypic resistance. Treatment-emergent resistance was defined as the presence of genotypic or phenotypic resistance from a post-Baseline sample in the setting of a previously non-resistant Baseline sample. The percentage of participants with treatment-emergent resistance was reported by study year for participants with H3N2 or H1N1pdm09 infections. Only data with evaluable participants were reported.|From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10) during Study Years 1, 2, 3, 4, 5, 6, 7|ALCIP Population. The “Number of Participants Analyzed” reflects combined H3N2 or H1N1pdm09-infected participants across all study years who provided an analyzable post-Baseline sample for their viral RNA subtype. The number of participants who provided evaluable data for each viral RNA subtype in the specified timeframe (n) is shown in the table.||percentage of participants|||Number
791027|NCT00884117|Primary|Number of Participants With Genotypic Resistance|"Samples were analyzed using reverse transcriptase-polymerase chain reaction (RT-PCR). Pre-defined mutations in viral ribonucleic acid (RNA) were noted, the presence of which was defined as genotypic resistance. The number of participants with genotypic resistance at Baseline was reported. The number of participants with genotypic resistance post-Baseline was determined by a collective count of all participants who had a resistance mutation at least once on Days 3, 6, and/or 10. (Hereafter, H stands for hemagglutinin and N stands for neuraminidase in abbreviations of viral subtype such as H1N1, H1N1pdm09, and H3N2.)"|Baseline (Day 1) and post-Baseline (Days 3, 6, 10)|All Laboratory-Confirmed Influenza Participants (ALCIP) Population: All with confirmed influenza by positive RT-PCR at Baseline. The “Number of Participants Analyzed” reflects the total of participants who provided evaluable data for their viral RNA subtype. The number who provided data for each viral RNA subtype in each timeframe (n) is shown.||participants|||Number
791028|NCT00884221|Secondary|Cumulative Live Birth for a Single Stimulation Cycle With Single Blastocyst Transfer From Fresh and 1 Year Frozen Embryo Replacement Cycles, Intention-to-treat (ITT) Analysis Set||Post-trial information|The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.||Percentage of participants||Standard Deviation|Mean
791030|NCT00884221|Secondary|Blastocyst Quality, Intention-to-treat (ITT) Analysis Set|"Blastocyst quality on day 5 was based on the blastocyst expansion and hatching status, inner cell mass grading and trophectoderm grading.
Excellent-quality blastocysts were defined as those with blastocyst expansion and hatching status 4, 5 or 6, inner cell mass grading A, and trophectoderm grading A or B. Good-quality blastocysts were defined as those with blastocyst expansion and hatching status 3, 4, 5 or 6, inner cell mass grading A or B, and trophectoderm grading A or B."|5 days after oocyte retrieval (120h post-insemination)|The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.||Number of blastocysts||Standard Deviation|Mean
791031|NCT00884221|Secondary|Fertilization, Intention-to-treat (ITT) Analysis Set|Fertilized oocytes with 2 pronuclei were regarded as correctly fertilized. Fertilization was estimated as (Number of oocytes with 2 pronuclei / number of metaphase II oocytes)*100|1 day after oocyte retrieval (19 h post-insemination)|The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.||Percentage of metaphase II oocytes||Standard Deviation|Mean
791032|NCT00884221|Secondary|Number of Oocytes Retrieved in Each Participant, Intention-to-treat (ITT) Analysis Set|Oocyte retrieval took place 36h (± 2h) after hCG administration. At oocyte retrieval, the number of oocytes retrieved was recorded.|36 h after hCG|The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.||Oocytes per participant||Standard Deviation|Mean
791033|NCT00884221|Secondary|Number of Follicles of >= 12mm, 12-14 mm, 15-16 mm and >= 17 mm in Each Participant, Intention-to-treat (ITT) Analysis Set|During the controlled ovarian stimulation, transvaginal ultrasound was performed to count the number of follicles and measure the size of the follicles.|Last stimulation day|The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.||Follicles per participant||Standard Deviation|Mean
791034|NCT00884221|Secondary|Endocrine Profile (Testosterone), Intention-to-treat (ITT) Analysis Set|Blood samples for analysis of circulating concentrations of endocrine parameters were drawn|On the last day of stimulation, blood was drawn at least 8 hours after the previous injection of gonadotrophin and GnRH antagonist|The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.||nmol/L||Standard Deviation|Mean
791035|NCT00884221|Secondary|Endocrine Profile (Sex Hormone Binding Globulin), Intention-to-treat (ITT) Analysis Set|Blood samples for analysis of circulating concentrations of endocrine parameters were drawn|On the last day of stimulation, blood was drawn at least 8 hours after the previous injection of gonadotrophin and GnRH antagonist|The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.||nmol/L||Standard Deviation|Mean
791036|NCT00884221|Secondary|Endocrine Profile (Prolactin), Intention-to-treat (ITT) Analysis Set|Blood samples for analysis of circulating concentrations of endocrine parameters were drawn|On the last day of stimulation, blood was drawn at least 8 hours after the previous injection of gonadotrophin and GnRH antagonist|The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.||pmol/L||Standard Deviation|Mean
791037|NCT00884221|Primary|Ongoing Pregnancy After One Fresh Embryo Replacement Cycle, Per-protocol (PP) Analysis Set|Transvaginal ultrasound showing at least one intrauterine viable fetus 10-11 weeks after embryo transfer at the blastocyst stage|10-11 weeks after embryo transfer at the blastocyst stage|The per-protocol (PP) analysis set was defined as all randomized and exposed participants except those excluded as a result of major protocol deviations, such as significant non-compliance or other serious unforeseen deviations deemed to invalidate the data and affect the conclusions of the trial.||Percentage of participants||Standard Deviation|Mean
791038|NCT00884221|Secondary|Endocrine Profile (Progesterone), Intention-to-treat (ITT) Analysis Set|Blood samples for analysis of circulating concentrations of endocrine parameters were drawn|On the last day of stimulation, blood was drawn at least 8 hours after the previous injection of gonadotrophin and GnRH antagonist|The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.||nmol/L||Standard Deviation|Mean
791039|NCT00884221|Secondary|Endocrine Profile (Luteinizing Hormone), Intention-to-treat (ITT) Analysis Set|Blood samples for analysis of circulating concentrations of endocrine parameters were drawn|On the last day of stimulation, blood was drawn at least 8 hours after the previous injection of gonadotrophin and GnRH antagonist|The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.||IU/L||Standard Deviation|Mean
791040|NCT00884221|Secondary|Endocrine Profile (Free Androgen Index), Intention-to-treat (ITT) Analysis Set|Blood samples for analysis of circulating concentrations of endocrine parameters were drawn. Free androgen index = (testosterone (nmol/L)/ sex hormone binding globulin (nmol/L))*100|On the last day of stimulation, blood was drawn at least 8 hours after the previous injection of gonadotrophin and GnRH antagonist|The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.||Percentage of participants||Standard Deviation|Mean
791041|NCT00884221|Secondary|Endocrine Profile (FSH), Intention-to-treat (ITT) Analysis Set|Blood samples for analysis of circulating concentrations of endocrine parameters were drawn|On the last day of stimulation, blood was drawn at least 8 hours after the previous injection of gonadotrophin and GnRH antagonist|The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.||IU/L||Standard Deviation|Mean
791042|NCT00884221|Secondary|Endocrine Profile (Estradiol), Intention-to-treat (ITT) Analysis Set|Blood samples for analysis of circulating concentrations of endocrine parameters were drawn|On the last day of stimulation, blood was drawn at least 8 hours after the previous injection of gonadotrophin and GnRH antagonist|The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.||pmol/L||Standard Deviation|Mean
791095|NCT00873821|Primary|Change From Baseline to Day 13 in Weighted Mean Plasma Glucose Concentration|Weighted mean plasma glucose concentration was calculated as the 24-hour area under the plasma concentration-time curve divided by 24|Baseline (predose Day 1) to Day 13|||mg/dL||Standard Deviation|Least Squares Mean
791045|NCT00884273|Secondary|Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables|The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) levels of safety laboratory variables. Only the laboratory variables that had at least one percentage of participants in either group with abnormal value are presented, more variables were included in the study.|Baseline to 12 weeks of treatment|Safety Analysis Set.||participants|||Number
791046|NCT00884273|Secondary|Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight|This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value.|Baseline to 12 weeks of treatment|Safety Analysis Set.||participants|||Number
791047|NCT00884273|Secondary|Change From Baseline in Burden of Urinary Symptoms Based on the Benign Prostatic Hyperplasia Impact Index (BPHII)|The Benign Prostatic Hyperplasia Impact Index (BPHII) is a self-administered questionnaire to measure how much urinary problems affect various domains of health. The higher value the worse are the urinary problems. The minimum possible total value is 0 and the maximum possible total value is 16.|After treatment of 4, 8, and 12 weeks compared to Baseline|FAS.||scores on a scale||Standard Deviation|Mean
791048|NCT00884273|Secondary|Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit|The IPSS questionnaire included an additional single question to assess the participant's QoL in relation to his urinary symptoms. The question was: 'If you were to spend the rest of your life with your urinary condition the way it is now, how would you feel about that?' The possible answers to this question ranged from 'delighted' (a score of '0') to 'terrible' (a score of '6').|After treatment of 4, 8, and 12 weeks compared to Baseline|FAS.||scores on a scale||Standard Deviation|Mean
791049|NCT00884273|Secondary|Change in Serum Prostate-Specific Antigen (PSA) Levels During the Study||At 4, 8, and 12 weeks compared to baseline.|FAS.||nanograms per milliliter||Full Range|Median
791050|NCT00884273|Secondary|Change in Serum Testosterone Levels During the Study||At 4, 8, and 12 weeks compared to baseline.|FAS.||nanograms per milliliter||Full Range|Median
791051|NCT00884273|Secondary|Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 4, 8, and 12|The IPSS is a tool commonly used to assess the severity of lower urinary tract symptoms (LUTS), and to monitor the progress of the disease once treatment has been initiated. The participant completes a questionnaire containing 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5. The total score is then classified according to the following scale: 0 to 7 = mildly symptomatic; 8 to 19 = moderately symptomatic; and 20 to 35 = severely symptomatic.|After treatment of 4, 8, and 12 weeks compared to Baseline|FAS, Last Observation Carried Forward (LOCF).||scores on a scale||Standard Deviation|Mean
791052|NCT00884273|Secondary|Change From Baseline in Prostate Size Based on TRUS at Week 4 and 8|TRUS is a method of measuring the size of the prostate.|After treatment of 4 and 8 weeks compared to Baseline|FAS, Last Observation Carried Forward (LOCF).||milliliter||Standard Deviation|Mean
791053|NCT00884273|Primary|Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Full Analysis Set)|TRUS is a method of measuring the size of the prostate.|After treatment of 12 weeks compared to Baseline|Full Analysis Set (FAS), Last Observation Carried Forward (LOCF).||milliliter||Standard Deviation|Mean
791054|NCT00884325|Secondary|Dermatology Life Quality Index (DLQI) Questionnaire Scores at Baseline, Week 2 and Week 4|Consented subjects who met inclusion/exclusion criteria were asked to complete a DLQI (Dermatology Life Quality Index)at Baseline, Week 2 and Week 4. The DLQI is a 10 item questionnaire broken down into 6 domains; symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment with a total score ranging from 0-30 (no effect on subject's life for 0, extremely large effect on subject's life for 30)|Baseline - Week 2 - Week 4|||units on a scale||Inter-Quartile Range|Median
791055|NCT00884325|Primary|Pruritus VAS Scores at Baseline, Week 2 and Week 4|Consented subjects who met inclusion/exclusion criteria were assigned either 5mg levocetirizine dihydrochloride (Xyzal) or placebo to be taken daily each evening for 28 days. Subjects were asked to complete a Visual Analog Scale to measure itch at Baseline, Week 2 and Week 4. The scale is an eleven point scale ranging from 0-10 with 0 indicating no itch to 10 indicating itch that frequently interferes with daily activities.|Baseline - Week 2-Week 4|||units on a scale||Inter-Quartile Range|Median
791056|NCT00884377|Secondary|Feasibility of a L. Major Species Specific Polymerase Chain Reaction as a Rapid Diagnostic Device in the Context of a Treatment Trial|Evaluate the feasibility of using species-specific PCR as a rapid diagnostic assay for L. major infection. The comparator modalities were: histopathology (identification of amastigotes); speciation determined through culture and isoenzyme analysis; and genus and species-specific PCR. Species PCR testing was performed at baseline to allow for the identification of L. major as each subject’s infecting parasite. If an L. major infection could not be confirmed in a subject’s lesion(s), then that subject could not be treated under this protocol.|at baseline before treatment|||Participants|||Count of Participants
791057|NCT00884377|Secondary|Immune Response, Based on Percent of T-Cell Population Before Treatment, and Day 10 Following Treatments|Evaluate the immune response (T-Cell population) to Leishmania before treatment, and at 10 days, in recipients of localized heat therapy vs systemic sodium stibogluconate. Days 1 and 10 are presented in columns.|day 1 and day 10|Percent of T-cells CD3+CD8, CD19, CD16+CD56 on study days 1 and 10||% of T-cells||95% Confidence Interval|Mean
791058|NCT00884377|Secondary|Immune Response, Based on T-Cell Population Before Treatment, and Day 10 Following Treatments|Evaluate the immune response (T-Cell population) to Leishmania before treatment, and at 10 days, in recipients of localized heat therapy vs systemic sodium stibogluconate. Days 1 and 10 are presented in columns.|day 1 and day 10|Populations of T-cells CD3+CD8, CD19, CD16+CD56 on study days 1 and 10||populations of T-cells||95% Confidence Interval|Mean
791059|NCT00884377|Secondary|Number of Participants With Solicited Adverse Events|To compare the toxicity profiles of ThermoMed treatment versus parenteral sodium stibogluconate therapy thru specific solicited adverse events|Days 3, 7 and 10|Data ia showing only subjects with specified solicited symptoms on Days 3, 7 and 10. Collective count of participants for SSG is 53 and 28 for ThermoMed over all reported days.||subjects showing specified symptoms|||Number
791060|NCT00884377|Secondary|Equivalence of Efficacy (Clinical Cure) of TheroMed Treatment vs Sodium Stibogluconate Assessed by the Number of Subjects With Clinical Cure|Determine the equivalence of efficacy (clinical cure) of ThermoMed treatment vs sodium stibogluconate in clinical response of all skin lesions at 12 months. Clinical cure is defined as complete epithelialization of lesion. Post-treatment, photographs of treated lesions were assessed for efficacy outcome by a consensus decision of leishmaniasis experts blinded as to each subject’s study group. On the basis of these photo assessments, “clinical response” was assessed by lesion and by subject. In addition, an “overall response” was assigned (“healed” or “not healed”) based on a combination of experts’ photo assessments and subject interviews. Efficacy outcomes for the 2 study groups were compared using the Fishers exact test.|12 months|||Participants|||Count of Participants
791061|NCT00884377|Primary|Equivalence of Efficacy Assessed by the Number of Participants With Clinical Cure|Assess whether local heat therapy using the ThermoMed device was equivalent (clinical cure) in efficacy to 10 days of parenteral sodium stibogluconate. Clinical cure is defined as complete epithelialization of lesion. post-treatment, photographs of treated lesions were assessed for efficacy outcome by a consensus decision of leishmaniasis experts blinded as to each subject’s study group. On the basis of these photo assessments, “clinical response” was assessed by lesion and by subject. In addition, an “overall response” was assigned (“healed” or “not healed”) based on a combination of experts’ photo assessments and subject interviews. Efficacy outcomes for the 2 study groups were compared using the Fishers exact test.|Assessment of cure is made at 2 months after treatment|A sample size of 27 subjects per treatment group was planned based on the assumption that the cure rate in the heat treatment arm would be 73% (Navin et al., 1990), compared to a 99% cure rate in the sodium stibogluconate arm (Wortmann et al., 2002).||Participants|||Count of Participants
791062|NCT00884390|Secondary|Incidence of Less-than-expected-therapeutic Effect (LETE) in the Prophylaxis Setting|The calculation of incidence of prophylaxis LETE used the number of bleeds identified as, or with a result of, LETE as the numerator (from the Prophylactic LETE CRF), and the denominator was the number of routine prophylaxis infusions. Each infusion was classified in the infusion log (“Prophylaxis/ On Demand/ Preventive”), and participants were instructed to select “On Demand” if the infusion was to treat a bleed, even if the participant typically followed a prophylaxis regimen. Only the infusions classified as “Prophylaxis” were counted in this denominator.|100 exposure days to study medication (approx. 2 years)|||percentage of bleeding episodes||95% Confidence Interval|Number
791063|NCT00884390|Secondary|Incidence of Less-than-expected-therapeutic Effect (LETE) in the On-demand Setting|The calculation of incidence of on-demand LETE used the number of bleeds identified as, or with a result of, LETE as the numerator (from the On Demand LETE CRF), and the denominator was the number of bleeding episodes treated in an on-demand setting. This denominator could include new bleeding episodes in prophylaxis participants breakthrough bleeds), and if subsequent on-demand doses for such a bleed met the on-demand LETE criteria, then an on-demand LETE was reported.|100 exposure days to study medication (approx. 2 years)|All enrolled participants who took at least 1 dose of ReFacto AF study drug were included in the safety and efficacy analyses.||percentage of bleeds LETE||95% Confidence Interval|Number
791064|NCT00884390|Secondary|Average Infusion Dose|The average infusion dose for each participant was calculated as his total factor consumption (in IU) divided by the number of infusions administered. Summary statistics were reported for both of these variables separately for those participants classified at baseline as following an on-demand regimen, and for those on a primary or secondary prophylaxis regimen.|100 exposure days to study medication (approx. 2 years)|All enrolled participants who took at least 1 dose of ReFacto AF study drug were included in the safety and efficacy analyses.||IU||Standard Deviation|Mean
791065|NCT00884390|Secondary|TFC Following a Prophylaxis Regimen at Baseline for All Participants|The total amount (in IU) infused for each test article infusion recorded in the Infusion Log Diary CRF was summed to calculate the TFC for each participant.|100 exposure days to study medication (approx. 2 years)|All enrolled participants who took at least 1 dose of ReFacto AF study drug were included in the safety and efficacy analyses.||IU||Standard Deviation|Mean
791066|NCT00884390|Secondary|Total Factor Consumption (TFC) Following a Non-prophylaxis Regimen at Baseline for All Participants|The total amount (in International Units [IU]) infused for each test article infusion recorded in the Infusion Log Diary CRF was summed to calculate the TFC for each participant.|100 exposure days to study medication (approx. 2 years)|All enrolled participants who took at least 1 dose of ReFacto AF study drug were included in the safety and efficacy analyses.||International Units (IU)||Standard Deviation|Mean
791067|NCT00884390|Secondary|Number of Participants With Breakthrough Bleeds|The number of participants with any breakthrough bleed was reported.|100 exposure days to study medication (approx. 2 years)|All enrolled participants who took at least 1 dose of ReFacto AF study drug were included in the safety and efficacy analyses.||participants|||Number
791068|NCT00884390|Secondary|Number of Bleeding Episodes Occurring ≤48 Hours After a Prophylaxis Infusion|First, the bleed start time from the Infusion Log Diary CRF was used to determine the number of breakthrough bleeds that occurred ≤48 hours after an infusion marked as “Prophylaxis” (which had no associated bleed). If there was more than 1 bleed location (ie, ankle and joint) with identical bleed start date and time, it was treated as 1 bleed occurrence. If a response was given, or if a bleed time was given, but “On Demand” was not listed as “treatment type”, it was still counted as an on-demand bleed for analyses/summaries. Bleeding episodes were not categorized as spontaneous (atraumatic) or traumatic.|100 exposure days to study medication (approx. 2 years)|All enrolled participants who took at least 1 dose of ReFacto AF study drug were included in the safety and efficacy analyses.||bleeds|||Number
791069|NCT00884390|Secondary|Number of ReFacto AF Infusions to Treat Each New Bleed|The Infusion Log Diary case report form (CRF) was used to determine the number of test article infusions administered to treat a bleed. This was calculated by adding the initial (on-demand) infusion to any subsequent (on-demand) infusions for the same bleed (same bleed start date/time).|100 exposure days to study medication (approx. 2 years)|All enrolled participants who took at least 1 dose of ReFacto AF study drug were included in the safety and efficacy analyses.||Number of Infusions||Standard Deviation|Mean
791096|NCT00873821|Primary|Number of Participants With Any Laboratory Adverse Experience|Laboratory adverse experiences were those related to changes in hematology, fasted blood chemistry, or urinalysis laboratory results. Adverse experiences were collected using MedDRA version 13.0.|2 months|All study participants||participants|||Number
791070|NCT00884390|Secondary|Response Assessment of First On-demand Treatment of New Bleeds|"A 4-point scale of assessment of ‘on-demand’ treatment (administration of an unscheduled bolus infusion of Refacto-AF to stop bleeding) is defined as:
Excellent: Definite pain relief and/or improvement in signs of bleeding starting within 8 hours after an infusion, with no additional infusion administered.
Good: Definite pain relief and/or improvement in signs of bleeding starting within 8 hours after an infusion, with at least one additional infusion administered for complete resolution of the bleeding episode; or, Definite pain relief and/or improvement in signs of bleeding starting after 8 hours following the infusion, with no additional infusion administered.
Moderate: Probable or slight improvement starting after 8 hours following the infusion, with at least one additional infusion administered for complete resolution of the bleeding episode.
No Response: No improvement at all between infusions or during the 24-hour interval following an infusion, or condition worsens."|100 exposure days to study medication (approx. 2 years)|All enrolled participants who took at least 1 dose of ReFacto AF study drug were included in the safety and efficacy analyses.||Number of observations|||Number
791071|NCT00884390|Secondary|Annualized Bleeding Rates (ABRs)|An ABR for each participant will be calculated as the number of bleeds requiring administration of FVIII replacement product (taken from the Infusion Log Diary case report form), divided by his total therapy duration (in days), then multiplied by 365.25.|100 exposure days to study medication (approx. 2 years)|All enrolled participants who took at least 1 dose of ReFacto AF study drug were included in the safety and efficacy analyses.||Number of bleeds||Standard Deviation|Mean
791072|NCT00884390|Primary|Number of Participants With Clinically Significant Factor VIII Inhibitor Development|Number of participants with clinically significant FVIII inhibitor development after switching from ReFacto to moroctocog alfa (AF-CC). Clinically significant inhibitors are defined as a central laboratory confirmed positive inhibitor (≥ 0.6 Bethesda unit (BU) using the Nijmegen modification of the Bethesda assay present at 2 consecutive blood draws within a 6-week interval) and within 28 days before the initial or within 28 days following the second positive FVIII inhibitor sample collection one of the following: the need for the participant to administer alternative hemostatic products in order to achieve sufficient efficacy, or ≥2 adverse event reports of decreased drug effect (or other adverse event indicating a decrease in the efficacy of the test article). The blood sample collection for these results must also be between the date of first dose of study medication and 28 days after the last dose of study medication.|100 exposure days to study medication (approx. 2 years)|All enrolled participants who took at least 1 dose of ReFacto AF study drug were included in the safety and efficacy analyses.||Number of participants||95% Confidence Interval|Number
791073|NCT00873327|Primary|Piperacillin Pharmacokinetics (PK)|To study how Piperacillin is metabolized in the body by measuring the drug concentration in plasma samples collected at different time points during the study|2-3 days after infant receives 1st drug dosing|All 32 subjects that were enrolled during the study.||L/hr/kg||95% Confidence Interval|Median
791074|NCT00873457|Secondary|Event-free Survival|Event-free survival will be defined as the length of time between the discontinuation of study treatment and disease progression, next therapy, or death,whichever comes first, up to a maximum of 2 years.|up to a maximum of 2 years|All treated patients||Days||Full Range|Median
791075|NCT00873457|Secondary|Overall Survival|Overall survival is defined as the length of time between discontinuation of perifosine until death or 2 year's followup, whichever comes first.|up to a maximum of 2 years|All treated patients||Days||Full Range|Median
791076|NCT00873457|Primary|Overall Response|Per International Workshop on Chronic Lymphocytic Leukemia, Complete Response (CR):normal CBC; absence of the following: clonal lymphocytes in blood and marrow, lymphadenopathy, hepatomegaly or splenomegaly, and constitutional symptoms; and bone marrow has <30% lymphocytes, is normocellular, and is without B-lymphoid nodules. Partial Response(PR): one of the following: decrease lymphadenopathy ≥ 50%; decrease of liver and/or spleen size ≥ 50%, any constitutional symptoms, Polymorphonuclear leukocytes ≥ 1,500/µl or a 50% improvement, or decrease of circulating clonal B lymphocytes ≥ 50% AND one of the following: Platelets ≥ 100,000/µl or a 50% improvement, Hemoglobin ≥ 11.0 g/dl or a 50% improvement, Bone marrow has ≥ 30% lymphocytes, or B-lymphoid nodules, or not done. Overall Response (OR)= CR+PR|after 6 months of treatment|Patients who completed 6 months of therapy||participants|||Number
791077|NCT00873457|Primary|Overall Response|Per International Workshop on Chronic Lymphocytic Leukemia, Complete Response (CR):normal CBC; absence of the following: clonal lymphocytes in blood and marrow, lymphadenopathy, hepatomegaly or splenomegaly, and constitutional symptoms; and bone marrow has <30% lymphocytes, is normocellular, and is without B-lymphoid nodules. Partial Response(PR): one of the following: decrease lymphadenopathy ≥ 50%; decrease of liver and/or spleen size ≥ 50%, any constitutional symptoms, Polymorphonuclear leukocytes ≥ 1,500/µl or a 50% improvement, or decrease of circulating clonal B lymphocytes ≥ 50% AND one of the following: Platelets ≥ 100,000/µl or a 50% improvement, Hemoglobin ≥ 11.0 g/dl or a 50% improvement, Bone marrow has ≥ 30% lymphocytes, or B-lymphoid nodules, or not done. Overall Response (OR)= CR+PR|after 3 months of treatment|Patients who completed 3 months of therapy.||participants|||Number
791078|NCT00873730|Secondary|Change in C-reactive Protein (CRP) From Baseline to Week 12.|CRP is a marker of inflammation and measured in mg/l. A higher level is consistent with inflammation.|Baseline and 12 weeks|The analysis population is the intent to treat.||mg/l||Standard Deviation|Mean
791079|NCT00873730|Secondary|Improvement of Ocular Inflammatory Disease in Patients With Baseline Symptoms||12 weeks|The population for this assessment was patients who had ocular inflammatory disease at baseline. The number of patients analyzed is zero because no patients had symptoms of ocular inflammatory disease at baseline.||patients|||Number
791080|NCT00873730|Secondary|Change in 36-Item Short-Form Health Survey (SF-36) From Baseline to Week 12.|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline and 12 weeks|The analysis population was the intent to treat population. Two scored areas had a different “Number of Participants Analyzed” in the etanercept arm. Bodily pain had 45 and Emotional role limitations had 46.||units on scale||Standard Deviation|Mean
791219|NCT00875433|Secondary|Area Under Curve 0-24 Hours (AUC0-24) on Day 1|AUC0-24 represents the area under the concentration curve of afatinib in plasma from 0 to 24 hours on Day 1.|0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 1|TS.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
791081|NCT00873730|Secondary|Ankylosing Spondylitis Quality of Life (EuroQoL) Questionnaire|EuroQol questionnaire is intended to measure the quality of life by means of questions about mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Answers to every question were grouped in two main categories: with problems (having some problems or absolutely unable) or without problems.|12 weeks|The analysis population was the intent to treat population.||patients|||Number
791082|NCT00873730|Secondary|Change in Erythrocyte Sedimentation Rate (ESR) From Baseline to Week 12.|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube and is measured in mm/hour. Normal range is 0-30mm/h. A higher rate is consistent with inflammation.|Baseline and 12 weeks|The analysis population was the intent to treat population.||mm/hour||Standard Deviation|Mean
791083|NCT00873730|Secondary|Change in Bath Ankylosing Spondylitis Metrology Index (BASMI) From Baseline to Week 12.|BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober’s test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.|Baseline and 12 weeks|The analysis population was the intent to treat population.||units on scale||Standard Deviation|Mean
791084|NCT00873730|Secondary|Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) From Baseline to Week 12.|BASDAI is a validated self assessment tool used to determine disease activity in patients with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale (VAS) of 0–10 (0=none and 10=very severe) patient’s answered 6 questions measuring discomfort, pain and fatigue. The BASDAI final mean score was calculated taking all 6 VAS assessments.|Baseline and 12 weeks|The analysis population was the intent to treat population.||units on scale||Standard Deviation|Mean
791085|NCT00873730|Secondary|Change in Bath Ankylosing Spondylitis Functional Index (BASFI) From Baseline to Week 12.|BASFI is a validated self assessment tool that determines the degree of functional limitation in AS patients. Utilizing a VAS of 0–10 (0=easy, 10=impossible), patients answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.|Baseline and 12 weeks|The analysis population was the intent to treat population.||units on scale||Standard Deviation|Mean
791086|NCT00873730|Secondary|Change in Physician and Patient Global Assessment (PGA) of Pain From Baseline to Week 12.|Patient pain assessed by physician and patient using a Visual Analog Scale (VAS) of 0 – 10 (0 = none and 10 = severe).|Baseline and 12 weeks|The analysis population was the intent to treat population.||units on scale||Standard Deviation|Mean
791087|NCT00873730|Secondary|Change in Nocturnal Back and Overall Spinal Pain From Baseline to Week 12.|Nocturnal back and overall spinal pain assessed by patients using a Visual Analog Scale (VAS) of 0 – 10 (0 = no pain and 10 = most severe pain).|Baseline and 12 weeks|The analysis population was the intent to treat population.||units on scale||Standard Deviation|Mean
791088|NCT00873730|Secondary|Number of Patients Achieving Partial Remission.|Partial remission defined as a score of less than 20 units (on a scale of 0–100, where 0=no disease activity, 100=high disease activity) in each of the 4 Assessment in Ankylosing Spondylitis (ASAS) domains: patient global assessment of disease activity, pain, function, and inflammation. For scale, 100=high disease activity.|12 weeks|The analysis population was the intent to treat population.||patients|||Number
791089|NCT00873730|Secondary|Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 5/6.|ASAS 5/6 consists of 6 domains: the 4 used in ASAS 20 (patient global assessment of disease activity, pain, function, inflammation measured on a 0-100 scale, where 0=no disease activity, 100=high disease activity) plus spinal mobility and an acute phase reactant, C Reactive Protein (CRP). Achieving ASAS 5/6 requires a 20% improvement compared to baseline in ≥ 5 domains and no worsening in the remaining domain.|12 weeks|The analysis population was the intent to treat population.||patients|||Number
791090|NCT00873730|Secondary|Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 70.|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) patients. ASAS = 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 70 = 70% improvement (vs. baseline) and an absolute change ≥ 20 units on a 0-100 scale (0=no disease activity, 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|12 weeks|The analysis population was the intent to treat population.||patients|||Number
791091|NCT00873730|Secondary|Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 50.|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) patients. ASAS = 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 50 = 50% improvement (vs. baseline) and an absolute change ≥ 20 units on a 0-100 scale (0=no disease activity, 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|12 weeks|The analysis population was the intent to treat population.||patients|||Number
791092|NCT00873730|Secondary|Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 40.|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) patients. ASAS = 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40% improvement (vs. baseline) and an absolute change ≥ 20 units on a 0-100 scale (0=no disease activity, 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|12 weeks|The analysis population was the intent to treat population.||patients|||Number
791093|NCT00873730|Primary|Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 20.|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) patients. ASAS = 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement (vs. baseline) and an absolute change ≥ 10 units on a 0-100 scale (0=no disease activity; 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|12 weeks|The analysis population was the intent to treat population.||patients|||Number
791094|NCT00873782|Primary|Muscle, Nerve, or Vascular Damage|"Number of Participants with all of the following three:
Unchanged Doppler ultrasound to assess venous and arterial damage pre-and post perfusion based on report
Without clinically significant changes in electrodiagnostic testing using standard neurographic techniques pre-and post perfusion:>1 mSec change in baseline distal motor latency; <75% baseline compound muscle action potential amplitude, <75% baseline conduction velocity, sensory nerve action potential
Without clinically significant changes in Quantitative muscle testing (QMT) strength assessments pre-and post perfusion:< 85% baseline"|Measured within 2 weeks after limb perfusion procedure|||participants|||Number
791098|NCT00873860|Secondary|Time to First Moderate or Severe Asthma Exacerbation|Time to first moderate or severe asthma exacerbation was defined as time to first observed progressive increase of asthma symptoms (cough, wheeze, chest tightness, and/or shortness of breath) or a reduction of >=20% in PEF or FEV1 from baseline that did not resolve after the initiation of rescue medications and resulted in an administration of systemic corticosteroids by the investigator or health care provider.|Day 1 to Day 92 and Day 169|Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons.||days||Standard Error|Mean
791099|NCT00873860|Secondary|Moderate or Severe Asthma Exacerbations Per Person Per Annum|Asthma exacerbation was defined as either a progressive increase of asthma symptoms (cough, wheeze, chest tightness, and/or shortness of breath) or a reduction of >=20% in PEF or FEV1 from baseline that did not resolve after the initiation of rescue medications and resulted in an administration of systemic corticosteroids by the investigator or health care provider. Asthma exacerbation rate, calculated as total asthma exacerbations per person per annum, was assessed based on asthma exacerbation data up to Day 92 and 169 (Rate = mean asthma exacerbations for all participants/X days*365 days, where X = 92 or 169).|Day 1 to Day 92 and Day 169|Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons.||asthma exacerbations/person/annum||Standard Error|Mean
791100|NCT00873860|Secondary|Percentage of Participants With at Least 1 Moderate or Severe Exacerbation|Asthma exacerbation was defined as either a progressive increase of asthma symptoms (cough, wheeze, chest tightness, and/or shortness of breath) or a reduction of >= 20 percent (%) in PEF or FEV1 from baseline that did not resolve after the initiation of rescue medications and resulted in an administration of systemic corticosteroids by the investigator or health care provider. Asthma exacerbation severity was classified as: 1) Moderate-worsening symptoms that required systemic corticosteroids. 2) Severe-worsening symptoms that required systemic corticosteroids and hospital admission.|Day 92 and 169|Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons. No separate analyses were performed for moderate and severe exacerbations since only 1 participant had a severe exacerbation.||Percentage of Participants|||Number
791101|NCT00873860|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and Day 169 that were absent before treatment or that worsened relative to pretreatment state.|Day 1 to 169|Safety population included all participants who received any dose of the investigational product.||participants|||Number
791102|NCT00873860|Secondary|Percentage of Participants With Positive Serum Antibodies to CAT-354 at Any Visit||Day 1, 92 and 169|Safety population included all participants who received any dose of the investigational product. Here, ‘N’(number of participants analyzed) signifies those participants who were evaluable for this measure.||percentage of participants|||Number
791103|NCT00873860|Secondary|Number of Participants With Anti-Drug Antibodies to CAT-354 at Any Visit||Day 1, 92 and 169|Safety population included all participants who received any dose of the investigational product. Here, ‘N’(number of participants analyzed) signifies those participants who were evaluable for this measure.||participants|||Number
791104|NCT00873860|Secondary|Serum Concentration for CAT-354||Predose on Day 15, 29, 43, 57, 71 and 85; Day 88, 92, 99, 127, and 169|Pharmacokinetic (PK) population included participants who received CAT-354 and had a sufficient number of serum concentration measurements for computing PK parameters. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||microgram per milliliter (mcg/mL)||Standard Deviation|Mean
791105|NCT00873860|Secondary|Percentage of Participants With Mean Asthma Control Questionnaire (ACQ) Score Less Than or Equal to 0.75 or ACQ Score Greater Than 0.75 But Less Than 1.5|Percentage of participants with mean Asthma Control Questionnaire (ACQ) score less than or equal to (<=) 0.75 or mean ACQ score greater than (>) 0.75 and less than (<) 1.5 were analyzed. The ACQ is a participant-reported questionnaire to assess the asthma control with 6 items assessing night-time waking, symptoms on waking, activity limitation, shortness of breath, wheeze, and rescue short-acting beta agonist use. Each item was rated on a 7-point Likert scale ranging from 0 (no impairment) to 6 (maximum impairment). Overall ACQ score is the mean of the 6 item scores with a score range of 0 (well controlled) to 6 (extremely poor controlled). Mean ACQ scores of less than or equal to (<=) 0.75 indicated well-controlled asthma, mean ACQ scores greater than (>) 0.75 but less than (<) 1.5 indicated partly controlled asthma.|Day 92 and 169|Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons.||percentage of participants|||Number
791106|NCT00873860|Secondary|Patient Global Impression of Change (PGIC)|Patient Global Impression of Change (PGIC): participant rated instrument to measure participant's change in overall status compared to baseline on a 7-point scale; range from 1 (very much worse) to 7 (very much better).|Day 92 and 169|Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons. Here, 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively.||units on a scale||Standard Deviation|Mean
791123|NCT00874029|Secondary|Change in Fibroid Symptom Severity and Quality of Life Scores at 12 Months Post-procedure as Compared to Pre-procedure (Baseline) Using the Uterine Fibroid Symptom and Health Related Quality of Life (UFS-QoL) Assessment Tool.|"The Uterine Fibroid Symptom and Health Related Quality of Life (UFS-QoL) assessment tool measures symptom severity and Health related quality of life.
Symptom Severity (SS) - high scores indicate greater symptoms (bad) and low scores indicate less symptoms (good). Scores range from 0 to 100. Since this outcome measure indicates change in symptoms, a negative number indicates a reduction in symptoms and therefore improvement.
Health Related (HRQL) - high scores indicate better health state. Scores range from 0 to 100. Since this outcome measure indicates change in health and quality of life, a positive number indicates and improvement."|12 months from Baseline|||Units on a scale||Standard Deviation|Mean
791107|NCT00873860|Secondary|Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169|Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]): a 32-item questionnaire that measures the functional impairments experienced by adult participants including 4 domains (Symptoms, Activity Limitations, Emotional Function, and Environmental Stimuli). Participants were asked to recall their experiences during the previous 2 weeks and to score each of the 32 questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score was calculated as the mean response to all questions. The 4 domain scores were the means of the responses to the questions in each of the domains. Overall AQLQ score and 4 domain scores ranged from 7 (no impairment) to 1 (severe impairment). Data collected on Day 1 prior to dosing was considered as baseline|Day 1, 29, 57, 92, 127 and 169|Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons. Here, 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively.||units on a scale||Standard Deviation|Mean
791108|NCT00873860|Secondary|Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores|Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]): a 32-item questionnaire that measures the functional impairments experienced by adult participants including 4 domains (Symptoms, Activity Limitations, Emotional Function, and Environmental Stimuli). Participants were asked to recall their experiences during the previous 2 weeks and to score each of the 32 questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score was calculated as the mean response to all questions. The 4 domain scores were the means of the responses to the questions in each of the domains. Overall AQLQ score and 4 domain scores ranged from 7 (no impairment) to 1 (severe impairment).|Day 1, 29, 57, 92, 127 and 169|Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons. Here, 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively.||units on a scale||Standard Deviation|Mean
791109|NCT00873860|Secondary|Number of Puffs of Rescue Beta-2 Agonist Per Week|Number of Puffs of Rescue Beta-2 Agonist Per Week Rescue beta-2 agonist use (total number of puffs for the preceding week) was collected daily in the morning by the participants in the daily diary provided to them. Average values for each week were reported starting from Day -7 to Day 169.|Day -7 to 169|Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons. Here, 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively.||puffs per week||Standard Deviation|Mean
791110|NCT00873860|Secondary|Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169|The PEF is a participant’s maximum speed of expiration, as measured with a peak flow meter. Home peak flow testing for PEF was performed every morning while sitting or standing prior to using any medication (if needed) for asthma. Mean of the data was collected over 1 week prior to dosing on Day 1 was considered as baseline. Mean PEF values for each week were used to calculate the change from baseline values starting from Day 2 to 169.|Day -7 to 1 (predose), Day 2 to 169|Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons. Here, 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively.||liters/minute||Standard Deviation|Mean
791111|NCT00873860|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites at Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169|Forced Expiratory Volume in 1 Second (FEV1) is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Spirometry was performed with the participant in the sitting/standing (kept consistent at each visit) position at study sites by the investigator or qualified designee according to American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines. Multiple forced expiratory efforts (at least 3 but no more than 8) were performed for each office spirometry session and the 2 best efforts that met ATS/ERS acceptability and reproducibility criteria were recorded. The best efforts were based on the highest FEV1. The maximum FEV1 of the 2 best efforts was used for the analysis. Data collected on Day 1 prior to dosing was considered as baseline.|Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169|Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons. Here, 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively.||liters||Standard Deviation|Mean
791112|NCT00873860|Secondary|Time to First Observed Asthma Control|Time to first asthma control was defined as the number of days from Study Day 1 to the post-baseline ACQ score measurement time point when greater than or equal to (>=) 0.5 reduction from baseline in mean ACQ score was first observed. Time to first asthma control was analyzed from Day 1 through Day 92 and up to entire study duration through Day 169. The ACQ score is a participant-reported questionnaire to assess the asthma control with 6 items assessing night-time waking, symptoms on waking, activity limitation, shortness of breath, wheeze, and rescue short-acting beta agonist use. Each item was rated on a 7-point Likert scale ranging from 0 (no impairment) to 6 (maximum impairment). Overall ACQ score is the mean of the 6 item scores with a score range of 0 (well controlled) to 6 (extremely poor controlled).|Day 1 to Day 92 and Day 169|Evaluable population = all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons. Since, >50% participants for each arm achieved improvement through Day 92; the median time-to-first observed achievement is identical for data through Day 92 and Day 169.||days||95% Confidence Interval|Median
791141|NCT00874250|Primary|The Number of Subjects Free From a Major Device Event Through 1 Month Post-treatment||Treatment through 1 month post treatment|||participants|||Number
791142|NCT00874276|Secondary|Terminal Half-life (the Amount of Time Needed to Clear One-half of the Dose of Drug)for Environmental Dose 2.5 ug/kg/Day.|Terminal half-life (the amount of time needed to clear one-half of the dose of drug)for the environmental dose 2.5 ug/kg/day.|24 hours for analysis on Day 5, Environmental dose|same as Primary||minutes||Inter-Quartile Range|Median
791220|NCT00875433|Secondary|Highest CTC Grade for Adverse Events|Highest Common Terminology Criteria (CTC) grade for adverse events|First administration of trial medication until 28 days after last administration of trial medication|All patients from TS with adverse events||Participants|||Number
791113|NCT00873860|Primary|Change From Baseline in the Mean Asthma Control Questionnaire (ACQ) Score at Day 92|Asthma Control Questionnaire (ACQ) is a participant-reported questionnaire to assess the asthma control with 6 items assessing night-time waking, symptoms on waking, activity limitation, shortness of breath, wheeze, and rescue short-acting beta agonist use. Each item was rated on a 7-point Likert scale ranging from 0 (no impairment) to 6 (maximum impairment). Overall ACQ score is the mean of the 6 item scores with a score range of 0 (well controlled) to 6 (extremely poor controlled). Data collected on Day 1 prior to dosing was considered as baseline. Results were reported for overall ACQ score.|Day 1 and 92|Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued prior to receiving 4 doses due to safety reasons. Here, ‘n’ signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.||units on a scale||Standard Deviation|Mean
791114|NCT00873873|Secondary|Protease/Antiprotease|"MMP9/TIMP 1 molar ratio MMP9 is matrix metalloproteinse 9 and is a protease enzyme that is responsible for tissue degradation of extracellular matrix and could be a factor in airway remodeling.
TIMP 1 is an abbreviation for tissue inhibitor of metalloproteinase-1 and is an inhibitor of MMP9 and would serve to balance the activity protease activity of MMP9 and this it is an anti-protease.
Therefore the ratio of MMP9 and TIMP1 is used to assess the relative balance of protease and antiprotease activity."|Measured at Year 2|54 participants had induced sputum data but 1 was excluded due to congenital anatomical anomaly (bronchial atresia).||ratio||Standard Deviation|Mean
791115|NCT00873873|Primary|Airway Wall Thickness|Segmental average airway wall thickness|Measured at Year 2|There were 43 participants with Chest CT data; 1 was excluded from the analysis due to incidental finding of an anatomical congenital anomaly.||mm||Standard Deviation|Mean
791116|NCT00873912|Secondary|Number of Participants Reporting at Least One Serious Adverse Event (SAE) or New Onset Chronic Disease (NOCD)|SAEs were those that resulted in death; were life-threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly/birth defect in the offspring of a study participant; or were an important medical event that may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above. An NOCD was a newly diagnosed medical condition of a chronic, ongoing nature and assessed by the investigator as medically significant.|Days 1-181 after vaccination|The Safety Population includes all subjects who received at least one dose of investigational product and experienced any follow-up for safety. Treatment group was assigned based on the actual investigational product received.||participants|||Number
791117|NCT00873912|Secondary|Number of Participants Reporting at Least One Serious Adverse Event (SAE) or New Onset Chronic Disease (NOCD)|SAEs were those that resulted in death; were life-threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly/birth defect in the offspring of a study participant; or were an important medical event that may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above. An NOCD was a newly diagnosed medical condition of a chronic, ongoing nature and assessed by the investigator as medically significant.|Days 1-29 after vaccination|The Safety Population includes all subjects who received at least one dose of investigational product and experienced any follow-up for safety. Treatment group was assigned based on the actual investigational product received.||participants|||Number
791118|NCT00873912|Secondary|Number of Participants Reporting Any Solicited Symptom or at Least One AE||Days 1-15 after vaccination|The Safety Population includes all subjects who received at least one dose of investigational product and experienced any follow-up for safety. Treatment group was assigned based on the actual investigational product received.||participants|||Number
791119|NCT00873912|Secondary|Number of Participants Reporting Any Solicited Symptom or at Least One Adverse Event (AE)|Solicited symptoms were collected from administration of investigational product through Study Day 15. For this study, solicited symptoms included: fever (> 100°F oral), runny nose, sore throat, cough, vomiting, muscle aches, chills, decreased activity (tiredness), headache.|Days 1-8 after vaccination|The Safety Population includes all subjects who received at least one dose of investigational product and experienced any follow-up for safety. Treatment group was assigned based on the actual investigational product received.||participants|||Number
791120|NCT00873912|Primary|Number of Participants Reporting Fever, Defined as Oral Temperature ≥ 101°F|The percentage of subjects with fever was compared between the two treatment groups based on the upper limit of the two-sided 95% exact confidence interval (CI) for the rate difference (monovalent vaccine minus placebo). The upper limit of the two-sided 95% CI was evaluated against the pre-specified equivalence criterion of 5 percentage points which corresponded to the following hypotheses: - H0 (null): rate difference ≥ 5 percentage points, - HA (alternative): rate difference < 5 percentage points.|Days 1-8 after vaccination|The Safety Population includes all subjects who received at least one dose of investigational product and experienced any follow-up for safety. Treatment group was assigned based on the actual investigational product received.||participants|||Number
791121|NCT00874029|Secondary|Overall Subject Treatment Outcome and Satisfaction Using the Overall Treatment Evaluation (OTE)|The Overall Treatment Evaluation Survey refers to whether the patient felt symptoms improved, worsened or remained the same post treatment.|12 months|||percentage of patients|||Number
791122|NCT00874029|Secondary|Change in Score on Questionnaire - General Health Outcome at 12 Months Post-procedure as Compared to Pre-procedure Using the EQ-5D (a Standardized Instrument for Use as a Measure of Health Outcome)|The EQ-5D is a standardized instrument with scores ranging from 0 to 100, for use as a measure of general health outcome, such as mobility, self-care, usual activities, pain/discomfort and anxiety and depression. An increase in the score post treatment indicates less disease burden.|12 months|||Units on a scale||Standard Deviation|Mean
791143|NCT00874276|Primary|Hypothesize That Subject's Genotype Will Determine How DCA is Metabolized.|Terminal half-life (the amount of time needed to clear one-half of dose of the drug).|24 hours for analysis on Day 5, Clinical dose|All completing subjects (2 withdrawals have no pharmacokinetic data on this parameter) The intent was to accrue 12 per group but the grant ended before that could be achieved. Subjects were recruited from a large pool but the two genetically defined subgroups are rare.||Minutes||Inter-Quartile Range|Median
791261|NCT00884832|Secondary|Percentage of Days With Fecal Incontinence (FI)||4 weeks baseline, 4 weeks treatment|||percentage of days||Standard Error|Mean
791124|NCT00874029|Secondary|Change in Uterine and Fibroid Volume at 12 Months Post-procedure Compared to Pre-procedure (Baseline) as Measured With Contrast-enhanced MRI (Magnetic Resonance Imaging)|Evaluate change from baseline in uterine volume and fibroid volume at 12 months post-procedure as measured by contrast-enhanced magnetic resonance imaging (MRI) measurements. Specifically, the outcomes of uterine and fibroid volume changes are expressed as a mean percentage of volume reduction. Treatment with RFA resulted in a reduction from baseline in total uterine and fibroid volume, as assessed by pretreatment and posttreatment MRI, at 3 and 12 months posttreatment.|12 month from Baseline|The Full Analysis Set (FAS) was used in the analysis of the change in total uterine and fibroid volumes between baseline and 12 months post treatment. Of the 137 Subjects enrolled, two were excluded from the FAS because they did not meet all of the inclusion/exclusion criteria.||percentage of volume||95% Confidence Interval|Mean
791125|NCT00874029|Primary|Surgical Re-Intervention for Menorrhagia at 12 Months Post-treatment|Patients who had surgical reintervention for bleeding prior to 12 months follow-up. Surgical reintervention success was defined as no surgical reintervention for menorrhagia within the 12-month posttreatment period.|12 months from Baseline|||participants|||Number
791126|NCT00874029|Primary|Incidence of Device and Procedure-related Adverse Events Within 12 Months Post-procedure|An adverse event was defined as any untoward medical occurrence in a subject who uses a medical device, regardless of the presumed relationship of the event to the study device. A serious adverse event is defined as an untoward medical occurrence that results in death, is life threatening, requires or prolongs hospitalization, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect. Preexisting conditions (i.e., underlying diseases that were present before the adverse event reporting period began), re-intervention for failure to meet the study endpoints, and pregnancy were not reported as adverse events. All adverse events that occured during the study were recorded on the Adverse Event case report form (CRF). The investigator recorded the adverse event and assessed the relationship of the adverse event to the device and/or procedure; the coding of the events was reviewed by the Clinical Events Committee (CEC).|12 months|||participants|||Number
791127|NCT00874029|Primary|Assessment of Menstrual Blood Flow (MBF) at 12 Months Post Procedure|Change in volume of menstrual blood loss at 12 months post-procedure compared to baseline. Bleeding relief and surgical reintervention were the co-primary endpoints. Bleeding relief success was defined for individual subjects as a ≥ 50% reduction from baseline in menstrual blood loss at 12 months posttreatment. The Primary Full Analysis Set was the primary analysis set for bleeding success rate.|12 months from Baseline|||Percentage of participants|||Number
791128|NCT00874094|Secondary|Difference in Wrinkle Assessment Score Between Pretreatment and 6 Weeks|Difference in Wrinkle Assessment Scores, values ranging from 0 (least noticeable) to 5 ( most noticeable) (scores on a scale), between Pre-treatment and 6 Weeks|Pre-treatment to 6 weeks after treatment|||units on a scale||Standard Deviation|Mean
791129|NCT00874094|Secondary|Difference in Wrinkle Assessment Score Between Pretreatment and 2 Weeks|Difference in Wrinkle Assessment Scores, values ranging from 0 (least noticeable) to 5 ( most noticeable) (scores on a scale), between Pre-treatment and 2 weeks|Pre-treatment to 2 weeks after treatment|||units on a scale||Standard Deviation|Mean
791130|NCT00874094|Secondary|Difference in Wrinkle Assessment Scores Between Pre-treatment and 1 Week|Difference in Wrinkle Assessment Scores, values ranging from 0 (least noticeable) to 5 ( most noticeable) (scores on a scale), between Pre-treatment and 1 week|pre-treatment to 1 week after treatment|The number of participants required to demonstrate a 1 point difference between pre and post treatment values||units on a scale||Standard Deviation|Mean
791131|NCT00874094|Primary|Difference in Wrinkle Assessment Score, Between Pre-treatment and 12 Weeks Post-treatment.|Difference in wrinkle assessment score, values ranging from 0 (least noticeable) to 5 ( most noticeable) (scores on a scale)between pre-treatment and 12 weeks post-treatment.|Difference in Measurements taken Pre-treatment and 12 weeks after treatment.|Number of participants were calculated based on need to achieve 1 unit improvement of Wrinkle Assessment score over baseline (pre-treatment) to be clinically relevant.||units on a scale||Standard Deviation|Mean
791133|NCT00874250|Secondary|Intensive Care Unit (ICU) Stay|Subjects admitted to ICU during index hospitalization|Initial Device Implant Index Hospitalization|||Participants|||Count of Participants
791134|NCT00874250|Secondary|Procedural Survival|Subjects who survived the index procedure|Initial Device Implant Procedure During Index Hospitalization|||Participants|||Count of Participants
791135|NCT00874250|Secondary|Time in Days to Return to Normal Daily Activities|This is the self reported time (in days) that the subject returned to pre-operative activities and is not a time to event analysis.|Average time within one month window|||Days||Full Range|Median
791136|NCT00874250|Secondary|Total Length of Hospital Stay (Days)|Total days of hospital stay during the initial hospitalization for implantation of device|Total Duration of the Index Hospitalization|||Days||Full Range|Median
791137|NCT00874250|Secondary|Days of Convalescence Stay in an Intensive Care Unit|Convalescence stay (days) in an Intensive Care Unit during the initial hospitalization for the device implantation|During the Index Hospitalization|||participants|||Number
791138|NCT00874250|Secondary|Operative Blood Loss (mL)|Blood loss in mL during initial device implantation procedure|Initial Device Implant Procedure During Index Hospitalization|||mL||Standard Deviation|Median
791139|NCT00874250|Secondary|Procedure Time (Minutes)|Total time in minutes required for surgical device implantation.|Initial Device Implant Procedure During Index Hospitalization|||Minutes||95% Confidence Interval|Median
791140|NCT00874250|Secondary|The Number of Subjects Experiencing a Serious Adverse Event Through One Month Post Treatment.||Treatment through 1 month post procedure|||participants|||Number
791144|NCT00874497|Secondary|Percentage of Participants Experiencing a COPD Exacerbation (Level 2 or Higher)|Percentage of participants experiencing a COPD exacerbation in a level 2 or higher are presented in the below outcome data table.|Baseline and Week 104|The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan.||percentage of participants|||Number
791145|NCT00874497|Secondary|Percentage of Participants With COPD Exacerbations by Group at Week 104|For the COPD exacerbations, baseline is defined as Randomization (Day 1). COPD exacerbations, defined as an acute worsening of COPD symptoms, were classified as being in one of 3 levels: Level I (can by self-managed by the participant); Level II (requires a physician visit), or Level III (requires a hospital visit).|Baseline and Week 104|The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan.||percentage of participants|||Number
791146|NCT00874497|Secondary|Change From Baseline to Week 104 in 7-day Mean Number of Actuations of Rescue Medications|Participants recorded rescue medication use (albuterol and/or ipratropium bromide) in a rescue medication log.|Baseline to Week 104|The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan. The number of participants analyzed at Week 104 were N = 14 and 9 respectively.||number of puffs||Standard Deviation|Mean
791147|NCT00874497|Secondary|Change From Baseline to Week 104 in 7-day Average Total Symptom Score of Dyspnea, Cough and Sputum|Participants used the Breathlessness, Cough, and Sputum Scale (BCSS) as the diary to daily monitor and rate their symptoms of difficulty breathing, cough, and sputum. The scale allows patients to rate each symptom on a scale of 0 (no difficultly for breathing and sputum, or unaware of coughing) to 4 (an almost constant problem for breathing and sputum, or almost constant for cough).|Baseline to Week 104|The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan. The number of participants analyzed at Week 104 were N = 13 and 9 respectively.||units on a scale||Standard Deviation|Mean
791148|NCT00874497|Secondary|Change From Baseline to Week 104 in Mean Specific Airway Resistance (sRaw) and Specific Conductance (sGaw)|Change from baseline in sRaw and sGaw is presented in the below outcome data table.|Baseline to Week 104|The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan. The number of participants analyzed at Week 104 were N = 23 and 15 respectively.||kPa.sec||Standard Deviation|Mean
791149|NCT00874497|Secondary|Change From Baseline to Week 104 in Carbon Monoxide Diffusion Capacity (DLco)|Change from Baseline in DLco is presented in the below outcome data table.|Baseline to Week 104|The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan. The number of participants analyzed at Week 104 were N = 23 and 15 respectively.||mmoL/min/kPA||Standard Deviation|Mean
791150|NCT00874497|Secondary|Change From Baseline to Week 104 in Trough Functional Residual Capacity (FRCpleth)|Change from baseline in trough FRCpleth is presented in the below outcome data table.|Baseline to Week 104|The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan. The number of participants analyzed at Week 104 were N = 23 and 15 respectively.||mL||Standard Deviation|Mean
791151|NCT00874497|Secondary|Change From Baseline to Week 104 in Trough Inspiratory Capacity|Change from Baseline in Trough Inspiratory Capacity is presented in the below outcome data table.|Baseline toWeek 104|The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan. The number of participants analyzed at Week 104 were N = 25 and 14 respectively.||mL||Standard Deviation|Mean
791152|NCT00874497|Secondary|Change From Baseline to Week 104 in Trough RV/TLC|Change from Baseline in Trough RV/TLC is presented in the below outcome data table.|Baseline to Week 104|The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan. The number of participants analyzed at Week 104 were n= 21 and 14 respectively.||unitless||Standard Deviation|Mean
791153|NCT00874497|Secondary|Change From Baseline to Week 104 in Computed Tomography (CT) - Derived Lung Volumes (Total Lung Capacity [TLC] and Residual Volume [RV])|Change from baseline in CT-derived lung volumes TLC and RV are presented in the below outcome data table.|Baseline to Week 104|The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan. The number of participants analyzed at Week 104 were N = 22 and 16 respectively.||mL||Standard Deviation|Mean
791154|NCT00874497|Secondary|Change From Baseline to Week 104 in Cumulative Frequency of HU|The area under the curve (AUC) is defined as the cumulative voxel frequency in HU (ie, the value of the density mask denominator). Blood samples (4 mL) for pharmacokinetic analysis were collected for the determination of plasma OPC-6535 concentrations at Predose on Day 1 and Weeks 26, 52, 78 and 104.|Baseline and Week 104|The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan. The number of participants analyzed at Week 104 were N = 23 and 16 respectively.||Hounsfield unit*hour||Standard Deviation|Mean
791155|NCT00874497|Secondary|Observed Rate of Change in Emphysema From Baseline to Week 104|The level of emphysema (g/L) within in a lung region is defined as the value of the selected percentile (10th, 15th, or 20th) in HU + 1000. The rate of change in the emphysema from baseline was calculated as the change in the level of emphysema from baseline to the specified visit divided by the time in years between the baseline and specified visit (i.e., [date of visit – date of baseline visit + 1]/365.25).|Baseline to Week 104|The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan. The number of participants analyzed at Week 104 were N = 23 and 16 respectively.||g/L||Standard Deviation|Mean
791170|NCT00874549|Post-Hoc|Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre- and Post-vaccination 1||Day 0 and Day 28 Post-vaccination 1|Geometric mean of serum bactericidal antibody titers using human complements (SBA-HC) pre- and post-vaccination 1 were determined in the per-protocol population. No data were collected for participants in Group 2.||Titers||95% Confidence Interval|Geometric Mean
791156|NCT00874497|Secondary|Rate of Change in the 20th Percentile of Lung Density Voxels Expressed in HU Units for the Whole Lung (Whole Right + Whole Left) From Baseline to Week 104|The rate of change in lung density was calculated as the change in the 20th percentile of lung density voxels divided by the duration between the dates of measurement (month or year) where applicable. For example, if HRCT measurements are available over a span of 2 years, the annual rate of change was calculated as the difference over the 2 years divided by 2, where years between scans is given by years= floor(data of last scan - date of first scan + 1)/365.25.|Baseline to Week 104|The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan. The number of participants analyzed at Week 104 were N = 46 and 26 respectively.||Hounsfield unit/year||Standard Deviation|Mean
791157|NCT00874497|Secondary|Density Mask Score Based on Specified Thresholds Including -950 HU|The density mask score is defined as the percentage of lung density voxels that lie below a specified threshold in the lung region of interest. The higher the percentage of the participant's lung density voxels that lie below a specified threshold, the higher the level of the participant's emphysema in the lung region under consideration. Changes in the density mask score was assessed using only a single density mask threshold of -950 HU.|Baseline and Week 104|The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan. The number of participants analyzed at Week 104 were N = 23 and 16 respectively.||Hounsfield unit||Standard Deviation|Mean
791158|NCT00874497|Secondary|Percent Change From Baseline in Trough FEV1 From Baseline to Week 104|The percent change for the pulmonary function tests (PFT) from baseline was calculated for each study week as follows: % change from baseline = ([value at Week X – value at baseline] /value at baseline) x 100.|Baseline to Week 104|The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan. The number of participants analyzed at Week 104 were N = 28 and 18 respectively.||percentage change||Standard Deviation|Mean
791159|NCT00874497|Primary|Rate of Change From Baseline to Week 104 in 20th Percentile of Lung Density Voxels|The analysis of the change from Baseline to Week 104 (LOCF) in the 20th percentile of lung density voxels (expressed in Hounsfield unit [HU] using quantitative HCRT) by visit and lung region is presented below.|Baseline to Week 104|The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan. The number of participants analyzed at Week 104 were N = 43 and 25 respectively.||Hounsfield unit/year||Standard Deviation|Mean
791160|NCT00874497|Primary|Change From Baseline to Week 104 in Trough Forced Expiratory Volume in 1 Second (FEV1)|The analysis of the change from Baseline to Week 104 (last observation carried forward [LOCF]) in trough FEV1 is presented below.|Baseline to Week 104|The Intent-to-Treat (ITT) population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable High-resolution computed tomography (HRCT) scan.||L||Standard Deviation|Mean
791161|NCT00874510|Primary|Hours Slept on Overnight Extended Duty Call Shifts|Two sites were separately analyzed for Mean Sleep Time for both Year 1 and Year 2.|12 months|||hours|Participants|95% Confidence Interval|Mean
791162|NCT00874549|Post-Hoc|Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre-vaccination 1 and Post-vaccination 2||Day 0 and 28 days post-vaccination|Serum bactericidal antibody using human complement (SBA-HC) pre-vaccination 1 and post-vaccination 2 were determined in the per-protocol population. No data were collected for participants in Group 1.||Percentage of Participants|||Number
791163|NCT00874549|Post-Hoc|Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1.||Day 28 Post-vaccination 1|Serum bactericidal antibody using human complement (SBA-HC) titers pre- and post-vaccination 1 were determined in the per-protocol population. No data were collected for participants in Group 2.||Percentage of Participants|||Number
791164|NCT00874549|Post-Hoc|Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre-vaccination 1 and Post-vaccination 2||Day 0 and Day 28 Post-vaccination 2|Geometric mean of serum bactericidal antibody titers using human complement (SBA-HC) pre-vaccination 1 and post-vaccination 2 were determined in the per-protocol population. No data were collected for participants in Group 1.||Titers||95% Confidence Interval|Geometric Mean
791165|NCT00874549|Other Pre-specified|Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8), Pre-vaccination 1 and Post-vaccination 2||Day 0 and Day 28 Post-vaccination 2|Serum bactericidal antibody using baby rabbit complement titer pre-vaccination 1 and post-vaccination 2 were determined in the per-protocol population. No data were collected for participants in Group 1.||Percentage of Participants|||Number
791166|NCT00874549|Other Pre-specified|Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1||Day 28 Post-vaccination 1|Serum bactericidal antibody titers using baby rabbit complement (SBA-BR) pre- and post-vaccination 1 were assessed in the per-protocol population. No data were collected for participants in Group 2.||Percentage of Participants|||Number
791167|NCT00874549|Other Pre-specified|Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre-vaccination 1 and Post-vaccination 2||Day 0 and 28 days Post-vaccination 2|Geometric mean titers of serum bactericidal antibody using baby rabbit complement pre-vaccination 1 and post-vaccination 2 was determined in per-protocol population. No data were collected for participants in Group 1.||Titers||95% Confidence Interval|Geometric Mean
791168|NCT00874549|Primary|Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2|Solicited systemic reactions: Fever (temperature), Headache, Malaise, Myalgia, chills, Arthralgia, Urticaria, Anorexia, Diarrhea, and Vomiting.|Day 0 to 7 Post-vaccination 2|Safety analysis post-vaccination 2 was on all enrolled and vaccinated participants, intent-to-treat population. No data were collected for participants in Group 1 and Group 2.||Participants|||Number
791169|NCT00874549|Primary|Number of Participants With At Least One Solicited Injection Site Reaction Post-Vaccination 2|Solicited injection site reactions: Pain, Erythema, and Swelling.|0-7 Days Post-vaccination 2|Safety analysis post-vaccination 2 was on all enrolled and vaccinated participants, intent-to-treat population. No data were collected for participants in Group 1.||Participants|||Number
791171|NCT00874549|Post-Hoc|Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Human Complement (SBA-HC) Post-vaccination 2||28 Days post-vaccination 2|Serum bactericidal antibody using human complements (SBA-HC) titers post-vaccination 2 was determined in the per-protocol population. No data were collected for participants in Group 1.||Percentage of Participants|||Number
791172|NCT00874549|Post-Hoc|Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Human Complement (SBA-HC) Post-vaccination 1||Day 28 Post-vaccination 1|Serum bactericidal antibody using human complements (SBA-HC) titers post-vaccination 1 were determined in the per-protocol population. No data were collected for participants in Group 2.||Percentage of Participants|||Number
791173|NCT00874549|Other Pre-specified|Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre- and Post-vaccination 1||Day 0 and Day 28 Post-vaccination 1|Geometric mean titers of serum bactericidal antibody using baby rabbit complement (SBA-BR) pre- and post-vaccination 1 were assessed in the per-protocol population. No data were collected for participants in Group 2.||Titers||95% Confidence Interval|Geometric Mean
791174|NCT00874549|Other Pre-specified|Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Baby Rabbit Complement (SBA-BR) Post-Vaccination 2||Day 28 Post-vaccination 2|Serum bactericidal antibody titers using baby rabbit complement (SBA-BR) post-vaccination 2, were assessed in the per-protocol population. No data were collected for participants in Group 1.||Percentage of Participants|||Number
791175|NCT00874549|Other Pre-specified|Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Baby Rabbit Complement (SBA-BR) Post-Vaccination 1.||Day 28 Post-vaccination 1|Serum bactericidal antibody titers using baby rabbit complement (SBA-BR) post-vaccination 1 were assessed in the per-protocol population. No data were collected for participants in Group 2.||Percentage of Participants|||Number
791176|NCT00874549|Primary|Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1.|Solicited injection site reactions: pain, erythema, and swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, Myalgia, chills, Arthralgia, Urticaria, Anorexia, Diarrhea, and Vomiting.|0-7 days post-vaccination 1|Safety analysis post-vaccination 1 was on all enrolled and vaccinated participants, intent-to-treat population.||Participants|||Number
791177|NCT00874770|Other Pre-specified|Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results|Clinically significant change in marked laboratory abnormalities (Grade 3 to 4 ) included: Alanine aminotransferase (ALT)- Grade 3 as >5.0 to 10.0* Upper Limit of Normal (ULN), Grade 4 as >10.0*ULN; Aspartate aminotransferase (AST)- Grade 3 as >5.0 to 10.0*ULN, Grade 4 as >10.0*ULN; Hemoglobin- Grade 3 as 7.0 to 8.9 g/dL, Grade 4 as <7.0 g/dL; Neutrophils- Grade 3 as 0.5 to 0.749*10^9/L, Grade 4 as <0.5*10^9/L; Lymphocytes- Grade 3 as 0.35 to 0.499*10^9/L, Grade 4 as <0.35*10^9/L; Total Bilirubin- Grade 3 as 2.6-5.0*ULN, Grade 4 as >5.0*ULN; Platelets- Grade 3 as 25000 to 49999*10^9/L, Grade 4 as <25000 10^9/L and white blood cells (WBC) - Grade 3 as 1000 to 1499*10^9/L, Grade 4 as <1000*10^9/L.|From screening up to Week 12 (treatment period)|All participants who received at least 1 dose of study drug. n=evaluable patients at the specified time point||participants|||Number
791178|NCT00874770|Secondary|Percentage of Participants With a Complete Early Virologic Response (cEVR) at Week 12|cEVR was defined as hepatitis C virus RNA <10 IU/mL at Week 12|At Week 12|All participants who received at least 1 dose of study drug.||percentage of participants|||Number
791179|NCT00874770|Secondary|Percentage of Participants With Early Virologic Response (EVR) at Week 12|EVR was defined as a ≥2 log10 decrease in hepatitis C virus (HCV) RNA from baseline at Week 12 , or HCV RNA <10 IU/mL for participants with baseline HCV RNA <1000 IU/mL.|At Week 12|All participants who received at least 1 dose of study drug.||percentage of participants|||Number
791180|NCT00874770|Secondary|Percentage of Participants With Rapid Virologic Response (RVR) at Week 4|RVR was defined as undetectable hepatitis C virus (HCV) RNA ie, HCV RNA less than the lower limit of detection (10 IU/mL) at Week 4.|At Week 4|All participants who received at least 1 dose of study drug.||percentage of participants|||Number
791181|NCT00874770|Primary|Percentage of Participants With Extended Rapid Virologic Response (eRVR) at Weeks 4 and 12|eRVR was defined as undetectable hepatitis C virus RNA less than the lower limit of detection (10 IU/mL) at Weeks 4 and 12.|A Weeks 4 and 12|All participants who received at least 1 dose of study drug.||percentage of participants|||Number
791182|NCT00874770|Other Pre-specified|Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Follow-up Period|An AE was defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a patient or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Treatment-related AE was defined as an AE that had certain, probable, possible, or unknown relationship to study drug.|From Day 31 up to Week 24 of post treatment follow-up|All participants who received at least 1 dose of study drug. n=evaluable patients||participants|||Number
791183|NCT00874770|Other Pre-specified|Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Treatment Phase|An AE was defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a patient or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Treatment-related AE was defined as an AE that had certain, probable, possible, or unknown relationship to study drug.|SAE: From Day 1 up to 30 days after last dose of study drug, AE: From Day 1 to 7 days after last dose of study drug|All participants who received at least 1 dose of study drug.||participants|||Number
791184|NCT00874822|Primary|Obstructive Sleep Apnea|The number patients with obstructive sleep apnea whether newly diagnosed or known at study entry.|9 Months|||participants|||Number
791185|NCT00874848|Secondary|Duration of Time to Progression (TTP) in Each Study Arm Based on Independent Central Radiology Review|"Time-to-progression (TTP) was defined as the time from the date of randomization to the first date of documented progressive disease. Progressive disease was identified by radiologic progressive disease according to modified RECIST v1.0, or in the case of the Investigator Radiologic Review, it may also be defined by clinical progression as determined by the investigator.
If a subject received any further anti-cancer therapy without prior documentation of disease progression, the subject was censored at the date of last tumor assessment before starting anti-cancer treatment. Subjects who died on study from other causes (not related to study disease) and subjects who were lost to follow-up or who were alive without documented progressive disease as of the data cut-off date for analysis were censored at the last tumor assessment date."|From time of randomization to first date of documented progression, or last tumor assessment date, up to 15 months|The primary efficacy population comprised all randomized subjects who had no major violations of inclusion/exclusion or significant protocol violations & received any amount of cetuximab, paclitaxel or carboplatin therapy or Imprime PGG, & had an evaluable baseline scan & at least one evaluable post-baseline response based on modified RECIST v1.0.||months||95% Confidence Interval|Median
791186|NCT00874848|Secondary|Duration of Objective Tumor Response in Each Study Arm Based on Independent Central Radiology Review|"The duration of objective tumor response was measured from the time at which criteria are met for CR or PR (whichever status is recorded first) until the first date on which recurrence or progressive disease is objectively documented per modified RECIST v1.0. Subjects who did not progress as of the data cutoff date were censored at their last tumor assessment date.
The analysis performed for this study utilized a modified RECIST v1.0 in which a confirmed response after the initial response assessment was not required by repeat assessment. With the use of centrally read, blinded radiological assessments performed by independent radiologists, and the use of randomization between study arms, the criterion requiring a 'confirmation' response was removed. All other RECIST v1.0 criteria remained unmodified and implemented as stated in the guidelines."|From the first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months|The primary efficacy population comprised all randomized subjects who had no major violations of inclusion/exclusion or significant protocol violations & received any amount of cetuximab, paclitaxel or carboplatin therapy or Imprime PGG, & had an evaluable baseline scan & at least one evaluable post-baseline response based on modified RECIST v1.0.||months||95% Confidence Interval|Median
791187|NCT00874848|Secondary|Complete Response (CR), Partial Response (PR), and Stable Disease (SD) Rates in Each Study Arm Based on Independent Central Radiology Review|"The best observed overall response rates were defined as the number of participants experiencing a best overall response of either complete response (CR), partial response (PR) or stable disease (SD) based on the modified RECIST v1.0 criteria. For stable disease (SD), follow-up measurements must have met the SD criteria at least once after study entry at a minimum interval of 6 weeks.
The analysis performed for this study utilized a modified RECIST v1.0 in which a confirmed response after the initial response assessment was not required by repeat assessment. With the use of centrally read, blinded radiological assessments performed by independent radiologists, and the use of randomization between study arms, the criterion requiring a 'confirmation' response was removed. All other RECIST v1.0 criteria remained unmodified and implemented as stated in the guidelines."|From the first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months|The primary efficacy population comprised all randomized subjects who had no major violations of inclusion/exclusion or significant protocol violations & received any amount of cetuximab, paclitaxel or carboplatin therapy or Imprime PGG, & had an evaluable baseline scan & at least one evaluable post-baseline response based on modified RECIST v1.0.||participants|||Number
791188|NCT00874848|Secondary|Disease Control Rate (DCR) in Each Study Arm Based on Independent Central Radiology Review|"The disease control rate (DCR) was defined as the number of participants experiencing a best overall tumor response of either CR, PR or SD. For stable disease (SD), follow-up measurements must have met the SD criteria at least once after study entry at a minimum interval of 6 weeks.
The analysis performed for this study utilized a modified RECIST v1.0 in which a confirmed response after the initial response assessment was not required by repeat assessment. With the use of centrally read, blinded radiological assessments performed by independent radiologists, and the use of randomization between study arms, the criterion requiring a 'confirmation' response was removed. All other RECIST v1.0 criteria remained unmodified and implemented as stated in the guidelines."|From first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months|The primary efficacy population comprised all randomized subjects who had no major violations of inclusion/exclusion or significant protocol violations & received any amount of cetuximab, paclitaxel or carboplatin therapy or Imprime PGG, & had an evaluable baseline scan & at least one evaluable post-baseline response based on modified RECIST v1.0.||participants|||Number
791189|NCT00874848|Secondary|Overall Survival (OS) in Each Study Arm Based on the Safety Population|Overall survival (OS) was defined as the time from the date of randomization until the date of documented death of the subject due to any cause, including death due to relapses that were successfully retreated. Subjects who were lost to follow-up or who were still alive at the time of analysis were censored at the last contact dates.|From the time of randomization to death, subject being lost to follow-up or study completion|The safety population comprised all randomized subjects who received any amount of Imprime PGG, cetuximab, paclitaxel or carboplatin.||months||95% Confidence Interval|Median
791200|NCT00875017|Secondary|Net Calcium Absorption|"Net Calcium Absorption (Lanthanum carbonate period) = Calcium ingested in meal minus (Rectal effluent calcium after Lanthanum carbonate + meal minus Rectal effluent calcium after fasting).
Net Calcium Absorption (Sevelamer Carbonate period) = Calcium ingested in meal minus (Rectal effluent calcium after Sevelamer carbonate + meal minus Rectal effluent calcium after fasting).
Net Calcium Absorption (Meal only period) = Calcium ingested in meal minus (Rectal effluent calcium after meal only minus Rectal effluent calcium after fasting)."|10 hours post-dose|PD set||mg||Standard Error|Least Squares Mean
791201|NCT00875017|Secondary|Net Phosphorous Binding|"Net Phosphorous Binding (Lanthanum carbonate period) = Rectal effluent phosphorous after Lanthanum carbonate + meal minus Rectal effluent phosphorous after meal only.
Net Phosphorous Binding (Sevelamer carbonate period) = Rectal effluent phosphorous after Sevelamer carbonate + meal minus Rectal effluent phosphorous after meal only."|10 hours post-dose|PD set||mg||Standard Error|Least Squares Mean
791190|NCT00874848|Primary|Objective Response Rate (ORR) in Each Study Arm Based on Independent Central Radiology Review|"Overall objective response rate was defined as the number of participants experiencing a best overall response of either complete response (CR) or partial response (PR) based on the modified RECIST v1.0 criteria.
The analysis performed for this study utilized a modified RECIST v1.0 in which a confirmed response after the initial response assessment was not required by repeat assessment. With the use of centrally read, blinded radiological assessments performed by independent radiologists, and the use of randomization between study arms, the criterion requiring a ‘confirmation’ response was removed. All other RECIST v1.0 criteria remained unmodified and implemented as stated in the guidelines."|From first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months|The primary efficacy population comprised all randomized subjects who had no major violations of inclusion/exclusion or significant protocol violations & received any amount of cetuximab, paclitaxel or carboplatin therapy or Imprime PGG, & had an evaluable baseline scan & at least one evaluable post-baseline response based on modified RECIST v1.0.||participants|||Number
791191|NCT00874887|Secondary|Minimum Inhibitory Concentration (MIC) Range at Day 14|MIC range at day 14. MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. The MIC cut-off values include: Intermediate is 1 to less than 2; Resistant is greater than or equal to 2. The MIC outcome measure was not analyzed due to the low number of data points.|Day 14|The microbiological (mITT) population consisted of randomized subjects who received study product and had at least one post-baseline microbiological efficacy measure. Data for this outcome measure were not analyzed due to the low number of data points.||micrograms per milliliter (ug/mL)|||Number
791192|NCT00874887|Secondary|Minimum Inhibitory Concentration 90 (MIC90) at Day 14|The Minimum Inhibitory Concentration 90 (MIC90) is the minimum concentration required to inhibit the growth of 90% of microorganisms. The MIC90 outcome measure was not analyzed due to the low number of data points.|Day 14|The microbiological (mITT) population consisted of randomized subjects who received study product and had at least one post-baseline microbiological efficacy measure. Data for this outcome measure were not analyzed due to the low number of data points.||micrograms per milliliter (ug/mL)|||Number
791193|NCT00874887|Secondary|Minimum Inhibitory Concentration 50 (MIC50) at Day 14|The Minimum Inhibitory Concentration 50 (MIC50) is the minimum concentration required to inhibit the growth of 50% of microorganisms. The MIC50 outcome measure was not analyzed due to the low number of data points.|Day 14|The microbiological (mITT) population consisted of randomized subjects who received study product and had at least one post-baseline microbiological efficacy measure. Data for this outcome measure were not analyzed due to the low number of data points.||micrograms per milliliter (ug/mL)|||Number
791194|NCT00874887|Secondary|Mutant Prevention Concentration (MPC) of the Conjunctiva at Day 14|Mutant Prevention Concentration (MPC) of the conjunctiva (clear membrane covering the white surface of the eye) at day 14. MPC is the lowest drug concentration which prevents growth of any colony of bacteria on the conjunctiva. The MPC outcome measure was not analyzed due to the low number of data points.|Day 14|The microbiological (mITT) population consisted of randomized subjects who received study product and had at least one post-baseline microbiological efficacy measure. Data for this outcome measure were not analyzed due to the low number of data points.||micrograms per milliliter (ug/mL)|||Number
791195|NCT00874887|Primary|Percentage of Subjects With Strain Resistance of the Conjunctiva as Determined by Minimum Inhibitory Concentration (MIC) at Day 14|Percentage of subjects with strain resistance as determined by Minimum Inhibitory Concentration (MIC) of the conjunctiva (clear membrane covering the white surface of the eye) at day 14. MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. The MIC cut-off values include: Intermediate is 1 to less than 2; Resistant is greater than or equal to 2.|Day 14|The microbiological (mITT) population consisted of randomized subjects who received study product and had at least one post-baseline microbiological efficacy measure. One patient in the Zymar® group did not have cultures performed at Day 14.||Percentage of Subjects|||Number
791196|NCT00874939|Secondary|Time Weighted Average of the Change From Baseline After Single Dose Administration of MK-0249, Measured by GMLT in Healthy Participants.|The GMLT measures executive function and spatial problem solving on a computer touch screen where participants learn a hidden pathway through a maze consisting of a 10 x 10 grid of tiles. The number of errors made for five consecutive trials at a single session is totaled, where lower number of errors indicates better performance. A change from baseline that is positive indicates improved function.|Baseline and 5-7 hours post-dose|Analysis was not performed due to termination of the study prior to randomization and treatment.|||||
791197|NCT00874939|Primary|Time Weighted Average of the Change From Baseline After Single Dose Administration of Donepezil 5 mg or Placebo, Measured by Groton Maze Learning Test (GMLT) in Healthy Participants|The GMLT measures executive function and spatial problem solving on a computer touch screen where participants learn a hidden pathway through a maze consisting of a 10 x 10 grid of tiles. The number of errors made for five consecutive trials at a single session is totaled, where lower number of errors indicates better performance. A change from baseline that is positive indicates improved function.|Baseline and 5-7 hours post-dose|Analysis was not performed due to termination of the study prior to randomization and treatment.|||||
791198|NCT00874939|Secondary|Time Weighted Average of the Change From Baseline After Single Dose Administration of MK-0249, Measured by GMLT in Participants With Alzheimer's Disease.|The GMLT measures executive function and spatial problem solving on a computer touch screen where participants learn a hidden pathway through a maze consisting of a 10 x 10 grid of tiles. The number of errors made for five consecutive trials at a single session is totaled, where lower number of errors indicates better performance. A change from baseline that is positive indicates improved function.|Baseline and 5-7 hours post-dose|Analysis was not performed due to termination of the study prior to randomization and treatment.|||||
791199|NCT00874939|Primary|Time Weighted Average of the Change From Baseline After Single Dose Administration of Donepezil 5 mg or Placebo, Measured by Groton Maze Learning Test (GMLT) in Participants With Alzheimer's Disease|The GMLT measures executive function and spatial problem solving on a computer touch screen where participants learn a hidden pathway through a maze consisting of a 10 x 10 grid of tiles. The number of errors made for five consecutive trials at a single session is totaled, where lower number of errors indicates better performance. A change from baseline that is positive indicates improved function.|Baseline and 5-7 hours post-dose|Analysis was not performed due to termination of the study prior to randomization and treatment.|||||
791202|NCT00875017|Primary|Net Phosphorous Absorption|"Net phosphorous absorption (Lanthanum carbonate period) = phosphorous ingested in meal minus (Rectal effluent phosphorous after Lanthanum carbonate + meal minus Rectal effluent phosphorous after fasting).
Net phosphorous absorption (Sevelamer Carbonate period) = Phosphorous ingested in meal minus (Rectal effluent phosphorous after Sevelamer carbonate + meal minus Rectal effluent phosphorous after fasting).
Net phosphorous absorption (Meal only period) = Phosphorous ingested in meal minus (Rectal effluent phosphorous after meal only minus Rectal effluent phosphorous after fasting)."|10 hours post-dose|Pharmacodynamic Set (PD) consists of subjects who provided all rectal effluent collections and completed all treatment periods. Subjects who vomited during any of the treatment periods were excluded from the PD set.||mg||Standard Error|Least Squares Mean
791203|NCT00875212|Primary|Minimum pH After 14 Days of Use of Dentifrice|measurement of pH obtained as described before. However, this time the biofilm was exposed to the dentifrices for a longer period (14 days).|14 days|The initial part of the work as a pilot study.||pH||Standard Deviation|Mean
791204|NCT00875212|Primary|Minimum pH|The dental biofilm pH was measured in vivo with the microtouch method, using a palladium microelectrode + reference electrode. Data represents the mean values of the lowest pH observed each time after the use of sucrose.|at 1 minute (minimum fermenting pH) or at 7 minutes|The number of subjects were determined by a pilot study carried out in 3 volunteers. The study has a crossover design. Thus the 4 groups of dentifrices tested included the same subjects in a different time-measurement avoiding the influence of individual variables in the analysis.||pH||Standard Deviation|Mean
791205|NCT00875329|Primary|Responses From the TBI Clinical Reminder|The presence or absence of symptomatic TBI as determined by the VA TBI Clinical Reminder screen was compared to presence or absence of a deployment-related TBI as determined by the study's criterion standard (i.e., the VA TBI Clinical Identification Interview) to determine concordance and calculate sensitivity and specificity of the VA TBI Clinical Reminder screen. Sensitivity of the screen was the percent of positive screens of those determined to be true positives by the VA TBI Clinical Identification Interview. Specificity was the percentage of negatives screens that were determined to be true negatives by the VA TBI Clinical Identification Interview.|April 2007 January 2012|||percentage of participants|||Number
791206|NCT00875394|Primary|Change From Baseline in Glycosylated Hemoglobin A1C (A1C) at Week 24|"Week 24 A1C minus baseline (Week 0) A1C. The unit for A1C is percent. Thus, this measure represents a difference of percent values."|Baseline and 24 weeks|Protocol deviations may have occurred that resulted in quality issues associated with reporting of the data.|||||
791207|NCT00875420|Primary|Percent Change in Composite Score Over Time|Percent change in composite score (frequency x severity) of hot flashes (Mild=1, Moderate=2, Severe=3) at 4 weeks compared to baseline, in the intent-to-treat population.|Week 4 minus baseline week|The intent-to-treat population is defined as all patients who received one or more doses of study drug.||Percent change from baseline||Standard Deviation|Mean
791208|NCT00875420|Secondary|Determine the Effects of RAD1901 on Luteinizing Hormone (LH) Over Time.|Percent change in LH levels at Day 29 compared to baseline, in the intent-to-treat population.|Day 29 minus baseline|The intent-to-treat (ITT) population is defined as all patients who received one or more doses of study drug. Based on patients who had a result on Day 29.||Percent change from baseline||Standard Deviation|Mean
791209|NCT00875420|Secondary|Determine the Effects of RAD1901 on Follicular Stimulating Hormone (FSH) Over Time.|Percent change in FSH at Day 29 compared to baseline, in the intent-to-treat population.|Day 29 minus baseline|The intent-to-treat (ITT) population is defined as all patients who received one or more doses of study drug. Based on patients who had a result on Day 29.||Percent change from baseline||Standard Deviation|Mean
791210|NCT00875420|Primary|Percent Change in Frequency of Hot Flashes Over Time|Percent change of moderate and severe hot flash frequency at 4 weeks compared to baseline using weekly Subject diary data, in the intent-to-treat population.|Week 4 minus baseline week|The intent-to-treat population is defined as all patients who received one or more doses of study drug.||Percent change from baseline||Standard Deviation|Mean
791211|NCT00875433|Secondary|Percentage Peak Trough Fluctuation (PTF)|PTF represents the percentage peak trough fluctuation. PTF is defined as difference between maximum and minimum concentration at steady state divided by the average concentration multiplied with 100 to report as percentage.|0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 14|Subset of TS, restricted to patients with adequate protocol compliance, i.e. patients without important protocol violations.||percentage of peak trough fluctuation||Geometric Coefficient of Variation|Geometric Mean
791212|NCT00875433|Secondary|Accumulation Ratio of AUC Values (R_A,Cmax)|R_A,Cmax represents the accumulation ratio of Cmax values after multiple dose administration over a uniform dosing interval t between days 1 and 14|0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 1 and 14|Subset of TS, restricted to patients with adequate protocol compliance, i.e. patients without important protocol violations.||ratio||Geometric Coefficient of Variation|Geometric Mean
791213|NCT00875433|Secondary|Accumulation Ratio of AUC Values (R_A,AUC)|R_A,AUC represents the accumulation ratio of AUC values after multiple dose administration over a uniform dosing interval t between days 1 and 14|0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 1 and 14|Subset of TS, restricted to patients with adequate protocol compliance, i.e. patients without important protocol violations.||ratio||Geometric Coefficient of Variation|Geometric Mean
791214|NCT00875433|Secondary|Time From Dosing to the Maximum Concentration of Afatinib in Plasma at Steady State (Tmax,ss)|tmax,ss represents the time from dosing to the maximum concentration of afatinib in plasma at steady state (Day 14).|0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 14|Subset of TS, restricted to patients with adequate protocol compliance, i.e. patients without important protocol violations.||hours||Full Range|Median
791215|NCT00875433|Secondary|Maximum Concentration of Afatinib in Plasma at Steady State (Cmax,ss)|Cmax,ss represents the maximum measured concentration of afatinib in plasma at steady state (Day 14).|0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 14|TS.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
791216|NCT00875433|Secondary|Area Under Curve of Afatinib Over a Uniform Dosing Interval Tau at Steady State (AUCtau,ss)|AUCtau,ss represents the area under the concentration curve of afatinib in plasma over a uniform dosing interval tau (24h) at steady state (Day14).|0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 14|TS.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
791221|NCT00875433|Secondary|Average Time-matched Heart Rate Change From Baseline to Day 14.|Average time-matched heart rate change from baseline to day 14.|The day before the first drug dose (baseline) and the day 14.|All patients in TS who had at least 1 time-matched pair of QT measurements available from baseline and from Day 14 of treatment.||bpm||Standard Error|Mean
791222|NCT00875433|Secondary|Patients With Notable Findings in QT on Day 14|Number of Patients with notable findings in QT on day 14. Notable findings are defined as a QT>500 ms.|Day 14|All patients from TS with data for QTcF on day 14||Participants|||Number
791223|NCT00875433|Secondary|Average Time-matched QT Change From Baseline to Day 14|Average time-matched QT change from baseline to day 14 over 1 to 24 hours following administration of afatinib.|The day before the first drug dose (baseline) and the day 14. Electrocardiograms (ECG) were performed at time point 0 and 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 10 h, 24 h thereafter.|All patients in TS who had at least 1 time-matched pair of QT measurements available from baseline and from Day 14 of treatment.||ms||Standard Error|Mean
791224|NCT00875433|Secondary|Time-matched QTcF Changes From Baseline to Day 14 at Each Time-point|Individual QTcF measurements at each time-point. Response was defined as the change from baseline. Analysis adjusted for baseline using a mixed model.|Baseline and day 14 (at 1, 2, 3, 4, 5, 6, 7, 10, 24 hours post-dose )|All patients in TS who had at least 1 time-matched pair of QT measurements available from either Day1 or Day 14 of treatment.||ms||Standard Error|Mean
791225|NCT00875433|Secondary|Patients With Clinically Relevant Findings in ECG on Day 14|Patients with clinically relevant findings in Electrocardiogram data (ECG) on day 14.|Day 14|All patients from TS with data for ECG on day 14||Participants|||Number
791226|NCT00875433|Secondary|Patients With Notable Findings in QTcF on Day 14|Notable findings are defined as a QTcF>500 ms or an increase in QTcF of >60ms.|Day 14|All patients from TS with data for QTcF on day 14||Participants|||Number
791227|NCT00875433|Secondary|Duration of Disease Control (DC)|Duration of Disease control (DC). DC was defined as CR, PR or stable disease (SD) and was assessed according to the Macdonald criteria for glioblastomas and brain metastases and according to RECIST for solid tumours (excluding glioblastomas).|Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.|TS.||weeks||95% Confidence Interval|Median
791228|NCT00875433|Secondary|Disease Control|Disease control was defined as CR, PR or stable disease (SD) and was assessed according to the Macdonald criteria for glioblastomas and brain metastases and according to RECIST for solid tumours (excluding glioblastomas).|Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.|TS.||Participants|||Number
791229|NCT00875433|Secondary|Overall Survival (OS)|Overall survival (OS) is defined as time from start of treatment to death.|Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.|TS.||weeks||95% Confidence Interval|Median
791230|NCT00875433|Secondary|Progression-free Survival (PFS)|PFS was defined as the time from the first treatment to the occurrence of tumour progression or death, whichever came first. It was assessed according to the Macdonald criteria for glioblastomas and brain metastases and according to RECIST for solid tumours (excluding glioblastomas) as well as by the investigators assessment. Median time results from unstratified Kaplan-Meier estimates.|Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.|All patients from TS who progressed or died.||weeks||95% Confidence Interval|Median
791231|NCT00875433|Primary|Average Time-matched QT Corrected by the Fridericia Formula (QTcF) Change From Baseline to Day 14|Average time-matched QT corrected by the Fridericia formula (QTcF) change from baseline to day 14 over 1 to 24 hours following administration of afatinib.|The day before the first drug dose (baseline) and the day 14. Electrocardiograms (ECG) were performed at time point 0 and 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 10 h, 24 h thereafter.|All patients in TS who had at least 1 time-matched pair of QT measurements available from baseline and from Day 14 of treatment.||ms||Standard Error|Mean
791232|NCT00875433|Primary|Objective Response (OR)|OR is defined as complete response and partial response (PR) and was assessed according to the Macdonald criteria for glioblastomas and brain metastases and according to Response Evaluation Criteria in Solid Tumours version 1.0 (RECIST) for solid tumours (excluding glioblastomas).|Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.|Treated Set (TS). TS consisted of all patients who received at least one dose of trial medication.||Participants with OR|||Number
791233|NCT00875485|Secondary|Number of Subjects With Serious Adverse Events (SAEs).|Serious adverse events (SAEs) assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.|One month after the administration of the challenge dose (Month 0 to Month 1)|Analysis was performed on Total Vaccinated cohort for challenge dose that included all subjects who received the challenge dose and for whom the immunogenicity data were available.||Subjects|||Number
791234|NCT00875485|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Symptoms.|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. Grade 3 = AE that prevented normal activity. Related = AE assessed by the investigator as causally related to the study vaccination.|During the 31-day (Day 0 to 30) follow-up period after the challenge dose.|Analysis was performed on Total Vaccinated cohort for challenge dose that included all subjects who received the challenge dose and for whom the immunogenicity data were available.||Subjects|||Number
791235|NCT00875485|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache and fever (axillary temperature). Gastrointestinal symptoms included nausea, vomiting, diarrhoea and/or abdominal pain. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature > 39.5°C. Related = general symptoms which were assessed by the investigator as causally related to vaccination.|During the 4-day (Day 0 to Day 3) follow-up period after the challenge dose.|Analysis was performed on Total Vaccinated cohort for challenge dose that included all subjects who received the challenge dose and for whom the immunogenicity data were available.||Subjects|||Number
791236|NCT00875485|Secondary|Anti-HBs Antibody Concentrations|Antibody concentrations are expressed as Geometric Mean concentrations (GMCs) in mIU/mL. The analysis was performed on anti-HBs seropositive subjects. Seropositive subjects are subjects with anti-HBs antibody concentrations >= 6.2 mIU/mL.|Before (PRE) and one month after (POST) the challenge dose|Analysis was performed on Total Vaccinated cohort for challenge dose that included all subjects who received the challenge dose and for whom the immunogenicity data were available.||mIU/mL||95% Confidence Interval|Geometric Mean
791237|NCT00875485|Secondary|Number of Subjects With Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations Equal to or Above the Cut-off Values|Anti-HBs antibody cut-off values assessed were >= 6.2 mIU/mL and >= 10 mIU/mL|Before (PRE) and one month after (POST) the challenge dose|Analysis was performed on Total Vaccinated cohort for challenge dose that included all subjects who received the challenge dose and for whom the immunogenicity data were available.||Subjects|||Number
791238|NCT00875485|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events.|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.|During the 4-day (Day 0 to Day 3) follow-up period after the challenge dose|Analysis was performed on Total Vaccinated cohort for challenge dose that included all subjects who received the challenge dose and for whom the immunogenicity data were available.||Subjects|||Number
791239|NCT00875485|Secondary|Anti-HAV Antibody Concentrations|Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on anti-HAV seropositive subjects. Seropositive subjects are subjects with anti-HAV antibody concentrations >= 15 mIU/mL.|Before (PRE) the challenge dose|Analysis was performed on Total Vaccinated cohort for challenge dose that included all subjects who received the challenge dose and for whom the immunogenicity data were available.||mIU/mL||95% Confidence Interval|Geometric Mean
791240|NCT00875485|Secondary|Number of Subjects With Anti-hepatitis A (HAV) Antibody Concentrations Equal to or Above the Cut-off Value.|"Anti-HAV antibody cut-off value assessed was >= 15 milli-International Units per milliliter (mIU/mL).
Note: Since none of the subjects were seronegative for anti-HAV antibody concentration at the pre-challenge time point, subjects received only the HBV vaccine as the challenge dose."|Before (PRE) the challenge dose|Analysis was performed on Total Vaccinated cohort for challenge dose that included all subjects who received the challenge dose and for whom the immunogenicity data were available.||Subjects|||Number
791241|NCT00875485|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs) or Hepatitis A or B Infection.|SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|Since the last long-term follow-up visit up to Year 15.|Analysis was performed on Long Term (LT) Total Cohort which included all subjects who returned at the current follow-up study and who belonged to the Total cohort in the primary study.||Subjects|||Number
791242|NCT00875485|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs) or Hepatitis A or B Infection.|SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|Since the last long-term follow-up visit up to Year 14.|Analysis was performed on Long Term (LT) Total Cohort which included all subjects who returned at the current follow-up study and who belonged to the Total cohort in the primary study.||Subjects|||Number
791243|NCT00875485|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs) or Hepatitis A or B Infection.|SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|Since the last long-term follow-up visit up to Year 13.|Analysis was performed on Long Term (LT) Total Cohort which included all subjects who returned at the current follow-up study and who belonged to the Total cohort in the primary study.||subjects|||Number
791244|NCT00875485|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs) or Hepatitis A or B Infection.|SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|Since the last long-term follow-up visit up to Year 12.|Analysis was performed on Long Term (LT) Total Cohort which included all subjects who returned at the current follow-up study and who belonged to the Total cohort in the primary study.||subjects|||Number
791245|NCT00875485|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs) or Hepatitis A or B Infection.|SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|Since the last long-term follow-up visit up to Year 11.|Analysis was performed on Long Term (LT) Total Cohort which included all subjects who returned at the current follow-up study and who belonged to the Total cohort in the primary study.||subjects|||Number
791246|NCT00875485|Primary|Number of Subjects With Anti-Hepatitis A (HAV) Antibody Concentrations Equal to or Above the Cut-Off Value.|Anti-HAV antibody cut-off value assessed was >= 15 milli-International Units per milliliter (mIU/mL).|At Year 11, 12, 13, 14 and 15 after the first vaccine dose of the two-dose or three-dose primary vaccination in study HAB-084.|Analysis was performed on subjects from the Long Term According-to-Protocol (LT ATP) cohort for immunogenicity on subjects with available data at the specified time-points.||subjects|||Number
791247|NCT00875485|Primary|Anti-HBs Anamnestic Response.|"Anamnestic response was defined as:
Anti-HBs antibody concentrations ≥ 10 mIU/mL at one month post-challenge dose in subjects seronegative at the pre-challenge time-points.
At least a 4-fold increase in anti-HBs antibody concentrations, at one month post-challenge dose in subjects seropositive at the pre-challenge time-points."|One month after the challenge dose.|Analysis was performed on Total Vaccinated cohort for challenge dose that included all subjects who received the challenge dose and for whom the immunogenicity data were available.||Subjects|||Number
791248|NCT00875485|Primary|Anti-HBs Antibody Concentrations|"Antibodys concentrations are expressed as Geometric Mean concentrations (GMCs) in mIU/mL. The analysis was performed on anti-HBs seropositive subjects. Seropositive subjects are subjects with anti-HBs antibody concentrations >= 6.2 mIU/mL.
Note: A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following complete retesting and reanalysis for years 11 to 13. Results of year 14 and year 15 were only analysed by CLIA."|At Year 11, 12, 13, 14 and 15 after the first vaccine dose of a two-dose or a three-dose primary vaccination in study HAB-084.|Analysis was performes on subjects from the Long Term According-to-Protocol (LT ATP) cohort forimmunogenicity on anti-HBs seropositive subjects with available data at the specified time-points.||mIU/mL||95% Confidence Interval|Geometric Mean
791249|NCT00875485|Primary|Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Equal to or Above the Cut-Off Values|Anti-HBs antibody cut-off values assessed were >= 6.2 mIU/mL and >= 10 mIU/mL. Note: A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following complete retesting and reanalysis for years 11 to 13. Results of year 14 and year 15 were only analysed by ChemiLuminescence ImmunoAssay (CLIA).|At Year 11, 12, 13, 14 and 15 after the first vaccine dose of the two-dose or three-dose primary vaccination in study HAB-084|Analysis was performed on subjects from the Long Term According-to-Protocol (LT ATP) cohort for immunogenicity on subjects with available data at the specified time-points||Subjects|||Number
791250|NCT00875485|Primary|Anti-HAV Antibody Concentrations|Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on anti-HAV seropositive subjects. Seropositive subjects are subjects with anti-HAV antibody concentrations >= 15 mIU/mL.|At Year 11, 12, 13, 14 and 15 after the first vaccine dose of two-dose or three-dose primary vaccination in study HAB-084|Analysis was performed on subjects from the Long Term According-to-Protocol (LT ATP) cohort for immunogenicity on anti-HAV seropositive subjects with available data at the specified time-points.||mIU/mL||95% Confidence Interval|Geometric Mean
791251|NCT00884585|Secondary|Percentage of Patients With an Improvement in the Punctate Corneal Staining Score|Punctate corneal staining improvement is defined as a 1 or more grade decrease from baseline in the study eye. The punctate corneal staining score is assessed on a scale of 0 to 5 where 0 is ≤2 dots, 1 is >2 dots but ≤ 10 dots, 2 is > 10 dots but ≤ 32 dots, 3 is > 32 dots but ≤ 100 dots (approximately), 4 is > 100 dots (approximately) but ≤ 316 dots (approximately), and 5 is >316 dots (approximately) or ulcer/erosion.|Baseline, Month 2|||Percentage of Patients|||Number
791252|NCT00884585|Secondary|Percentage of Patients With an Improvement in the Composite Symptom Score|Composite symptom score improvement is defined as a 4 or more grade decrease from baseline in composite symptom score in the study eye. The composite symptom score is based on 5 symptoms (itching, tearing, ocular discomfort, photophobia, mucous discharge). Each of the 5 symptoms is assessed on a scale of 0=absent to 3=severe. The composite symptom score is the sum of all 5 individual symptom scores, where 0 is no symptoms and 15 is the most severe symptoms.|Baseline, Month 2|Intent to Treat: all randomized patients||Percentage of Patients|||Number
791253|NCT00884585|Secondary|Percentage of Punctate Corneal Staining Responders|Punctate corneal staining responders defined as patients achieving a punctate corneal staining score of 0 or 1 in the study eye. Punctate corneal staining is assessed on a scale of 0 to 5 where 0 is ≤2 dots, 1 is >2 dots but ≤ 10 dots, 2 is > 10 dots but ≤ 32 dots, 3 is > 32 dots but ≤ 100 dots (approximately), 4 is > 100 dots (approximately) but ≤ 316 dots (approximately), and 5 is >316 dots (approximately) or ulcer/erosion.|Month 2|Intent to Treat: all randomized patients||Percentage of Patients|||Number
791254|NCT00884585|Primary|Percentage of Treatment Responders|Treatment responders are defined as patients with a ≥ 1 grade improvement from baseline in punctate corneal staining score and a ≥ 4 grade improvement from baseline in composite symptom score in the study eye. The punctate corneal staining score is assessed on a scale of 0 to 5 (0 is ≤2 dots and 5 is >316 dots (approximately) or ulcer/erosion). The composite symptom score is based on 5 symptoms (itching, tearing, ocular discomfort, photophobia, mucous discharge). The composite symptom score (0 to 15) is the sum of 5 symptoms (each symptom is assessed on a scale of 0=absent to 3=severe).|Baseline, Month 2|Intent to Treat: all randomized patients||Percentage of Patients|||Number
791255|NCT00884741|Other Pre-specified|Neurocognitive Function Measured by the Hopkins Verbal Learning Test-Revised(HVLT-R), Trail Making Test Part A, Trail Making Test Part B, Controlled Oral Word Association Test (COWAT)||Analysis can occur at or after time of primary outcome measure analysis.||||||
791256|NCT00884741|Other Pre-specified|Quality of Life Measured by the M.D. Anderson Symptom Inventory Brain Tumor Module (MDASI-BT Tool) and EORTC Quality of Life Questionnaire-Core/Brain Cancer Module( QLQ-C30/BCM20)||Analysis can occur at or after time of primary outcome measure analysis.||||||
791257|NCT00884741|Secondary|Incidence of Grade 3 and Higher Treatment-related Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (AEs) Version 3.0|AEs are graded by using CTCAE 3.0. The difference between the two randomized arms in the percentage of patients with grade 3 or higher toxicities reported as possibly/probably/definitely related to protocol treatment will be tested using a chi square test.|Up to 30 days|Eligible randomized patients with adverse event data who started study treatment.||participants|||Number
791258|NCT00884741|Primary|Progression-free Survival (PFS)|Progression-free survival was defined as time from randomization to date of progression, death, or last follow-up, and was estimated by the Kaplan-Meier method. Patients last known to be alive were censored at the date of last contact. This analysis was planned to occur when 390 deaths had been reported.|From randomization to date of progression, death, or last follow-up for progression-free survival. Analysis occurs after all 390 deaths have been reported.|All eligible randomized patients||months||95% Confidence Interval|Median
791259|NCT00884741|Primary|Overall Survival (OS)|Survival time was defined as time from randomization to date of death from any cause and was estimated by the Kaplan-Meier method. Patients last known to be alive were censored at the date of last contact. This analysis was planned to occur when 390 deaths had been reported.|From randomization to date of death or last follow-up. Analysis occurs after all 390 deaths have been reported.|All eligible randomized patients||months||95% Confidence Interval|Median
791260|NCT00884832|Secondary|Percentage of Days With FI Post-treatment Adjusted for Baseline|The “adjustment for baseline” was an analysis of covariance (ANCOVA) where the covariate was the baseline version of the endpoint.|4 weeks treatment|||percentage of days||Standard Error|Mean
791262|NCT00884832|Secondary|Percentage of Bowel Movements With Semi-formed and Loose Stools Post-treatment Adjusted for Baseline|The percentage of bowel movements with semi-formed and loose stools was defined as those with a score of 5-7 on the Bristol stool form scale. The “adjustment for baseline” was an analysis of covariance (ANCOVA) where the covariate was the baseline version of the endpoint.|4 weeks treatment|Intent to treat analysis||percentage of bowel movements||Standard Error|Mean
791263|NCT00884832|Secondary|Percentage of Bowel Movements With Semi-formed and Loose Stools in Subjects With and Without Diarrhea|The percentage of bowel movements with semi-formed and loose stools was defined as those with a score of 5-7 on the Bristol stool form scale.|4 weeks baseline, 4 weeks treatment|Intent to treat analysis||percentage of bowel movements||Standard Error|Mean
791264|NCT00884832|Secondary|Percentage of Bowel Movements Preceded by Rectal Urgency|Rectal urgency is defined as a sudden, irresistible need to have a bowel movement. Scores were averaged over the 4 week baseline period and the 4 week treatment periods.|4 weeks baseline, 4 weeks treatment|Intent to treat analysis||percentage of bowel movements||Standard Error|Mean
791265|NCT00884832|Secondary|Satisfaction With Treatment|"This parameter was determined by a 100 mm visual analog scale, with possible scores ranging from 0 = Not satisfied at all (no relief of symptoms) to 100 = Completely satisfied (symptoms resolved). The parameter was computed from weekly diaries. Scores were averaged over the 4 week baseline period and the 4 week treatment periods."|4 weeks baseline, 4 week treatment|Intent to treat analysis||units on a scale||Standard Error|Mean
791266|NCT00884832|Secondary|Impact of Fecal Incontinence on Post-Treatment Quality of Life|"Scores were computed from a post-treatment questionnaire, the Fecal Incontinence Quality of Life Scale. This scale is composed of a total of 29 items; these items form four scales: Lifestyle (10 items) Coping/Behavior (9 items), Depression/Self Perception (7 items), and Embarrassment (3 items).
Scales range from 1 to 4; with a 1 indicating a lower functional status of quality of life. Scales scores are the average (mean) response to all items in the scale (that is, add the responses to all questions in a scale together and then divide by the number of items in the scale, adjusting for missing values)."|after 4 weeks treatment|Intent to treat analysis||units on a scale||Standard Error|Mean
791267|NCT00884832|Secondary|Impact of Fecal Incontinence on Baseline Quality of Life|"Scores were computed from a pre-treatment questionnaire, the Fecal Incontinence Quality of Life Scale. This scale is composed of a total of 29 items; these items form four scales: Lifestyle (10 items) Coping/Behavior (9 items), Depression/Self Perception (7 items), and Embarrassment (3 items).
Scales range from 1 to 4; with a 1 indicating a lower functional status of quality of life. Scales scores are the average (mean) response to all items in the scale (that is, add the responses to all questions in a scale together and then divide by the number of items in the scale, adjusting for missing values)."|4 weeks baseline|Intent to treat analysis||units on a scale||Standard Error|Mean
791268|NCT00884832|Secondary|Mean Severity of Fecal Incontinence|The Fecal Incontinence Severity Index was used to compute the severity of fecal incontinence (FI). It is a validated 4-item scale used to assess the frequency of 4 different types of FI (gas, mucus, liquid stool, solid stool). The subject responses are weighted and summed for the 4 types of FI. Scores could range from 0 (no symptoms) to 61 (very frequent FI). Values were computed from pre- and post- treatment questionnaires.|4 weeks baseline, 4 weeks treatment|Intent to treat analysis||units on a scale||Standard Error|Mean
791269|NCT00884832|Secondary|Mean Percentage of Bowel Movements Which Were Incontinent|Values were averaged over 4 week baseline and 4 week treatment periods.|4 weeks baseline, 4 weeks treatment|Intent to treat analysis||percentage of bowel movements||Standard Error|Mean
791270|NCT00884832|Secondary|Mean Number of Fecal Incontinence Episodes|Values were averaged over 4 week baseline and 4 week treatment periods.|4 weeks baseline, 4 weeks treatment|Intent to treat analysis||number of episodes||Standard Error|Mean
791271|NCT00884832|Secondary|Mean Number of Days With Fecal Incontinence|Values were averaged over 4 week baseline and 4 week treatment periods.|4 weeks baseline, 4 weeks treatment|Intent to treat analysis||days||Standard Error|Mean
791272|NCT00884832|Primary|Mean Fecal Incontinence and Constipation Assessment (FICA) Score|The FICA severity scale has 4 items (frequency, type, amount of leakage, and presence of urgency) and is used to rate the severity of fecal incontinence. The parameter was computed from values in the weekly diaries. The FICA score can range from 1 to 13. Symptom severity scores of 1–6, 7–10, and 11–13 are categorized as mild, moderate, and severe, respectively. Scores were averaged over the 4 week baseline period and the 4 week treatment periods.|4 weeks baseline, 4 weeks treatment|Intent to treat analysis||units on a scale||Standard Error|Mean
791273|NCT00884897|Secondary|To Determine Whether OT Improves Measures of Social Anxiety.|To determine whether OT improves measures of social anxiety as measured by the Social Interaction Anxiety Scale. This assessment has 20 items scored 0-4 for a total minimum score of 0 and maximum score of 80. The lower the score the better the outcome.|Outcomes are compared between Baseline and endpoint|||units on a scale||Standard Deviation|Mean
791274|NCT00884897|Primary|To Determine Whether Exogenous OT Enhances Emotional Intelligence and Improves Performance on Measures of Social Cognition for Schizophrenia or Schizoaffective Patients|Mayer-Salovay Caruso Emotional Intelligence Test (Mayer et al., 2002; MSCEIT) This is a self report instrument that consists of 141 items and 8 ability subscales, which assess four components (branches) of emotion processing: identifying emotions, using emotions, understanding emotions, and managing emotions. For this study we will focus on the managing emotions and understanding emotions components. There are 29 total items assessed with a total score ranging from 5-145. The higher the score the better the outcome.|participants are assessed at baseline and end point|||units on a scale||Standard Deviation|Mean
791275|NCT00884910|Primary|Patient Preference|"Patients were asked Which voice prosthesis do you prefer? Answer options were old one (Provox2), new one (Provox Vega 22.5), or no preference."|3 months post insertion, or at end of device life (whichever comes sooner)|All patients that participated in the study and finished it were analyzed||Patients|||Number
791290|NCT00885105|Other Pre-specified|Geometric Mean Titers (GMTs) for Polyribosylribitol Phosphate and Pneumococcal Antibodies After Concomitant Vaccination With Fluzone® Vaccine.|Human antibodies to Streptococcus pneumoniae (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were determined by an Enzyme linked immunosorbent assay (ELISA).|Day 28 post-vaccination|Geometric Mean Titers (GMTs) for Polyribosylribitol Phosphate and Pneumococcal antibodies were determined in the per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
791276|NCT00884910|Secondary|Device Life Time|Periodic replacement of voice prostheses is considered a normal event. Over time, the device is affected by Candida which may hinder closure of the valve flap. The device life time of the voice prosthesis is determined by leakage through the device that occurs because of incomplete closure of the valve flap. At the time of analysis (6 months after placement of the devices), 25 devices had been replaced because of leakage through the device and 8 devices were still in situ. The outcomes that are reported concern the 25 devices that had been replaced.|6 months|Six months after placement of the devices, 25 out of 33 had been replaced for leakage through the device. The median device life time is based on all 33 devices. The maximum of the range reflects the 6 months cut off and not the actual maximum device life time, because of the devices still in situ at the time of analysis.||Days||Full Range|Median
791277|NCT00884949|Primary|Subject Incidence of Treatment Emergent AEs|"The primary objective of the study was to evaluate the safety of weekly infusions of BMN 110 administered in escalating doses to subjects with MPS IVA.
The safety variable incidence of TEAE is summarized."|Entire Study, through week 84|||participants|||Number
791278|NCT00884949|Secondary|Percent Change From Baseline in FVC|Percent Change from baseline in Forced Vital Capacity.|Baseline to Weeks 12, 24, 36, 72|Intent-to-Treat population (all subjects who enrolled in the study). The analysis was based on observed cases.||percentage of FVC||Standard Deviation|Mean
791279|NCT00884949|Secondary|Percent Change From Baseline in MVV|Percent Change from baseline in Maximum Voluntary Ventilation.|Baseline to Weeks 12, 24, 36, 72|Intent-to-Treat population (all subjects who enrolled in the study). The analysis was based on observed cases.||percentage of MVV||Standard Deviation|Mean
791280|NCT00884949|Secondary|Percent Change From Baseline in uKS|Percent Change from baseline in Normalized Urine KS. The percent change was calculated (Week X value - baseline value)/baseline value *100%|Baseline to Weeks 12, 24, 36, 72|Intent-to-Treat population (all subjects who enrolled in the study). The analysis was based on observed cases.||percentage of uKS||Standard Deviation|Mean
791281|NCT00884949|Secondary|Change From Baseline in 3MSCT|Change from baseline in the 3-minute Stair Climb Test. Patients walked up stairs that have a railing, which could be used for support, for 3 minutes, with the number of stairs climbed recorded. The test result was the number of steps climbed per minute.|Baseline to Weeks 12, 24, 36, 48, 72|Intent-to-Treat population (all subjects who enrolled in the study). One patient was developmentally unable to perform the 3MSCT and the test scores were set to missing. The analysis was based on observed cases.||steps/min||Standard Deviation|Mean
791282|NCT00884949|Secondary|Change From Baseline in 6MWT|Change from baseline in meters in 6-minute Walk Test. As a measure of endurance, a 6-minute walk test (6MWT) was performed according to the American Thoracic Society Guidelines. Patients were instructed to walk as far as possible in 6 minutes.|Baseline to Weeks 12, 24, 36, 48, 72|Intent-to-Treat population (all subjects who enrolled in the study). Two patients were either physically (score was designated as 0 m) or developmentally (score was set to missing) unable to perform the 6MWT. The analysis was based on observed cases.||meters||Standard Deviation|Mean
791283|NCT00885079|Primary|Change in Lissamine Green Conjunctival Staining (LGCS) Score From Baseline|LGCS indicates the damage to the conjunctival epithelium. Per the National Eye Institute/Industry Workshop report, the conjunctiva was divided into 6 fractions, each of which was given a staining sdore from 0 to 3, and the total score was calculated (0-18). 0 is better. Superiority was verified by comparing t-test results for change from baseline in the LGCS score (LOCF) between 2 treatment groups.|Baseline, Weeks4|||units on a scale||Standard Deviation|Mean
791284|NCT00885079|Primary|Change in Fluorescein Corneal Staining (FCS) Score From Baseline|FCS indicates the damage to the corneal epithelium. Per the National Eye Institute/Industry Workshop report, the cornea was divided into 5 fractions, each of which was given a staining score from 0 to 3, and the total score was calculated (0-15). 0 is better. Noninferiority for change from baseline in the FCS score (LOCF) was determined by comparing the noninferiority margin (0.4) with the upper limit of the 95% confidence interval (CI) of the difference between the 2 treatment groups|Baseline, Weeks4|||units on a scale||Standard Deviation|Mean
791285|NCT00885092|Secondary|Percentage of Participants With Solution-Related Corneal Staining|Corneal staining was assessed by the investigator using fluorescein dye, a yellow filter, and a slit lamp. Corneal staining was graded on a continuous scale of 0% (no staining in the region) to 100% (staining covers entire region) in 1% increments for 5 corneal regions (central, nasal, temporal, inferior, and superior). Solution-related corneal staining was defined as ≥20% corneal staining area in at least 3 corneal regions of both eyes and is reported as a percentage of total participants.|Day 7, Hour 14|Intent to treat: All participants who received regimen and had at least one on-therapy visit. Cross-over study design.||Percentage of participants|||Number
791286|NCT00885092|Secondary|Mean Lens Comfort|"Lens comfort was assessed by the participant on a 5-point Likert scale prior to any examination. The participant was instructed to select a single response to the statement, My lenses feel comfortable right now, with 1 = strongly disagree, 2 = disagree, 3 = undecided, 4 = agree, and 5 = strongly agree."|Day 7, Hour 14|Intent to treat: All participants who received regimen and had at least one on-therapy visit. Cross-over study design.||Units on a scale||Standard Deviation|Mean
791287|NCT00885092|Primary|Mean Ex-Vivo Wetting Angle|Study lens was removed from the eye according to protocol-specified procedures. The OCA15 (Optical Contact Angle) Instrument was used to observe, record, and calculate contact angle measurements. The wetting angle measurement was recorded in degrees (0-180), and a lower wetting angle measurement indicates a more wettable lens.|Day 7, Hour 14|Intent to treat: All participants who received regimen and had at least one on-therapy visit. Cross-over study design.||Degrees||Standard Deviation|Mean
791288|NCT00885105|Other Pre-specified|Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine.|Solicited injection site reactions: Tenderness, erythema and swelling. Solicited systemic reactions: Fever (temperature), vomiting, abnormal crying, drowsiness, loss of appetite, and irritability.|Days 0 up to 7 post-vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population||Percentage of Participants|||Number
791289|NCT00885105|Other Pre-specified|Geometric Mean Titers (GMTs) for Polio Antibodies After Concomitant Vaccination With Fluzone® Vaccine.|Antibodies to polio viruses were measured by a serum neutralization assay.|Day 28 post-vaccination|Geometric Mean Titers (GMTs) for the Polio antibodies were determined in the per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
791291|NCT00885105|Other Pre-specified|Geometric Mean Titers (GMTs) for Pertussis, Tetanus, Diphtheria, and Haemophilus Influenzae, Antigens Post-vaccination With Fluzone® Vaccine.|"Antibodies against Pertussis, Tetanus, and Haemophilus influenzae antigens were determined by an indirect Enzyme linked immunosorbent assay (ELISA).
Anti-diphtheria antibody response was measured by the Vero Cells - diphtheria toxin challenge method.
The serological determinations of total anti-PRP antibody was performed using a Farr-type radioimmunoassay."|Day 28 Post-vaccination|GMTs to the Pertussis, Tetanus, Diphtheria and Haemophilus Influenzae antigens were assessed in the per-protocol immunogenicity population.||Titers||95% Confidence Interval|Geometric Mean
791292|NCT00885105|Other Pre-specified|Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibody Titers Post-Vaccination With Fluzone® Vaccine.|Antibodies against Influenza virus in Fluzone® Vaccine determined by the Hemagglutination inhibition (HAI) assay method.|Day 28 Post-vaccination|Geometric Mean Titers to the Influenza vaccine antigens were assessed in the per-protocol immunogenicity population.||Titers||95% Confidence Interval|Geometric Mean
791293|NCT00885105|Primary|Summary of Influenza Seroprotection Post-vaccination With Fluzone® Vaccine.|Seroprotection was defined as a Reciprocal Hemagglutination Inhibition Titers of ≥ 40 Post-vaccination with Fluzone® Vaccine.|Day 28 Post-vaccination|Hemagglutination inhibition titers to the Influenza vaccine antigens were assessed in the per-protocol immunogenicity population.||Percentage of Participants|||Number
791294|NCT00885118|Secondary|CLR,ss|renal clearance of the analyte at steady state determined over the dosing interval τ|Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 0-5h, 5-12h, 12-24h after last drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data||mL/min||Geometric Coefficient of Variation|Geometric Mean
791295|NCT00885118|Secondary|fe0-24,ss|fraction of the analyte excreted unchanged in urine at steady state from time interval 0 to 24|0-5, 5-12, 12-24 hour after last drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data||percentage of Ae0-24 (to dosage)||Geometric Coefficient of Variation|Geometric Mean
791296|NCT00885118|Secondary|Ae0-24,ss|amount of the analyte that is eliminated in urine at steady state over the time interval 0 to 24|0-5, 5-12, 12-24 hour after last drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data||nmol||Geometric Coefficient of Variation|Geometric Mean
791297|NCT00885118|Secondary|RA,AUC|accumulation ratios of the analyte in plasma after 28 doses (once daily) over a uniform dosing interval τ, based on AUCτ|Predose, 15min, 30min, 45min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration, and predose, 15min, 30min, 45min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h after last drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data||ratio||Geometric Coefficient of Variation|Geometric Mean
791298|NCT00885118|Secondary|RA,Cmax|accumulation ratios of the analyte in plasma after 28 doses (once daily) over a uniform dosing interval τ, based on Cmax|Predose, 15min, 30min, 45min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration, and predose, 15min, 30min, 45min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h after last drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data||ratio||Geometric Coefficient of Variation|Geometric Mean
791299|NCT00885118|Secondary|Vz/F,ss|apparent volume of distribution during the terminal phase λz following an extravascular dose at steady state|Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h 48h, 72h after last drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data||Liter||Geometric Coefficient of Variation|Geometric Mean
791300|NCT00885118|Secondary|CL/F,ss|apparent clearance of the analyte in plasma after extravascular administration at steady state|Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h 48h, 72h after last drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data||mL/min||Geometric Coefficient of Variation|Geometric Mean
791301|NCT00885118|Secondary|t1/2,ss|terminal half-life of the analyte in plasma at steady state|Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h 48h, 72h after last drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data||hour||Geometric Coefficient of Variation|Geometric Mean
791302|NCT00885118|Secondary|Cmax,ss|maximum measured concentration of the analyte in plasma at steady state|Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h 48h, 72h after last drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data||nmol/L||Geometric Coefficient of Variation|Geometric Mean
791303|NCT00885118|Secondary|AUCτ,ss|area under the concentration-time curve of the analyte in plasma over a uniform dosing interval τ at steady state|Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h after last drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
791304|NCT00885118|Secondary|CLR,0-24|renal clearance of the analyte in plasma after extravascular administration – based on 0-24 hours data|Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min, 0-5h, 5-12h, 12-24h after first drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data||mL/min||Geometric Coefficient of Variation|Geometric Mean
791305|NCT00885118|Secondary|fe0-24|fraction of the analyte excreted unchanged in urine from time interval 0 to 24|0-5, 5-12, 12-24 hour after first drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data||percentage of Ae0-24 (to dosage)||Geometric Coefficient of Variation|Geometric Mean
791306|NCT00885118|Secondary|Ae0-24|amount of the analyte that is eliminated in urine over the time interval 0 to 24|0-5, 5-12, 12-24 hour after first drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data||nmol||Geometric Coefficient of Variation|Geometric Mean
791307|NCT00885118|Secondary|Vz/F|apparent volume of distribution during the terminal phase λz following an extravascular dose|Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data||Liter||Geometric Coefficient of Variation|Geometric Mean
791308|NCT00885118|Secondary|CL/F|apparent clearance of the analyte in plasma after extravascular administration|Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data||mL/min||Geometric Coefficient of Variation|Geometric Mean
791309|NCT00885118|Secondary|t1/2|terminal half-life of the analyte in plasma|Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data||hour||Geometric Coefficient of Variation|Geometric Mean
791310|NCT00885118|Secondary|Cmax|maximum measured concentration of the analyte in plasma|Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data||nmol/L||Geometric Coefficient of Variation|Geometric Mean
791311|NCT00885118|Secondary|AUC0-∞|area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity|Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
791312|NCT00885118|Secondary|AUC0-tz|area under the concentration-time curve of the analyte in plasma over the time interval from 0 to last quantifiable plasma concentration|Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
791313|NCT00885118|Secondary|AUCτ,1|Area under the concentration-time curve of the analyte in plasma after administration of the first dose over a uniform dosing interval τ|Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
791314|NCT00885118|Secondary|Change From Baseline in the Area Under the Curve of Insulin Levels Until 4 Hours After Intake of a Standardised Food (Meal Tolerance Test)|Change from baseline in the area under the curve of insulin levels until 4 hours after intake of a standardised food (meal tolerance test) to 28 days|baseline and 28 days|Full analysis set (FAS)||hr*uU/mL||Standard Error|Least Squares Mean
791315|NCT00885118|Secondary|Change From Baseline in the Area Under the Curve of Glucagon Levels Until 4 Hours After Intake of a Standardised Food (Meal Tolerance Test)|Change from baseline in the area under the curve of glucagon levels until 4 hours after intake of a standardised food (meal tolerance test) to 28 days|baseline and 28 days|Full analysis set (FAS)||hr*pg/mL||Standard Error|Least Squares Mean
791316|NCT00885118|Secondary|Change From Baseline in the Area Under the Curve of Plasma Glucose Levels Until 4 Hours After Intake of a Standardised Food (Meal Tolerance Test)|Change from baseline in the area under the curve of plasma glucose levels until 4 hours after intake of a standardised food (meal tolerance test) to 28 days|baseline and 28 days|Full analysis set (FAS)||hr*mg/dL||Standard Error|Least Squares Mean
791317|NCT00885118|Secondary|Change From Baseline in Fasting Insulin|Change from baseline in Fasting insulin to 28 days|baseline and 28 days|Full analysis set (FAS)||uU/mL||Standard Error|Least Squares Mean
791318|NCT00885118|Secondary|Change From Baseline in 1,5-anhydroglucitol|Change from baseline in 1,5-anhydroglucitol to 28 days|baseline and 28 days|Full analysis set (FAS)||ug/mL||Standard Error|Least Squares Mean
791319|NCT00885118|Secondary|Change From Baseline in Fructosamine|Change from baseline in Fructosamine to 28 days|baseline and 28 days|Full analysis set (FAS)||umol/L||Standard Error|Least Squares Mean
791320|NCT00885118|Secondary|Change From Baseline in HbA1c|Change from baseline in HbA1c to 28 days|baseline and 28 days|Full analysis set (FAS)||percentage of HbA1c||Standard Error|Least Squares Mean
791321|NCT00885118|Primary|Change From Baseline in 8-point Glucose|Change from baseline in 8-point glucose to 27 days|baseline and 27 days|Full analysis set (FAS)||mg/dL||Standard Error|Least Squares Mean
791322|NCT00885118|Primary|Change From Baseline in Fasting Plasma Glucose|Change from baseline in Fasting plasma glucose to 28 days|baseline and 28 days|Full analysis set (FAS)||mg/dL||Standard Error|Least Squares Mean
791323|NCT00885118|Primary|Change From Baseline in Urine Glucose Excretion|Change from baseline in Urine glucose excretion to 28 days|baseline and 28 days|Full analysis set (FAS)||mg||Standard Error|Least Squares Mean
791324|NCT00885170|Secondary|Percent Change From Baseline in Log-Transformed Serum 25-Hydroxyvitamin D at Month 24|The 25-hydroxy vitamin D [25(OH)D] test is the most accurate way to measure vitamin D. In the kidney, 25-hydroxy vitamin D is converted into 1,25 di-hydroxyvitamin D, the active vitamin D metabolite.|Baseline and Month 24|The population analyzed included all randomized, treated participants who had 25(OH)D data at Baseline and Month 24 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history.||Percent Change||95% Confidence Interval|Least Squares Mean
791325|NCT00885170|Secondary|Percent Change From Baseline in Log-Transformed Serum 1,25 Dihydroxyvitamin D at Month 24|1,25 dihydroxyvitamin D [1,25(OH)2 D] is the active vitamin D metabolite and stimulates calcium absorption in the intestine.|Baseline and Month 24|The population analyzed included all randomized, treated participants who had 1,25(OH)2 D data at Baseline and Month 24 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history.||Percent Change||95% Confidence Interval|Least Squares Mean
791326|NCT00885170|Secondary|Percent Change From Baseline in Log-Transformed Serum Parathyroid Hormone at Month 24|Serum parathyroid hormone (SPH) regulates calcium, phosphorus, and vitamin D levels in the blood.|Baseline and Month 24|The population analyzed included all randomized, treated participants who had SPH data at Baseline and Month 24 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history.||Percent Change||95% Confidence Interval|Least Squares Mean
791327|NCT00885170|Secondary|Percent Change From Baseline in Log-Transformed Serum Phosphate at Month 24|Serum phosphate is an index of mineral homeostasis.|Baseline and Month 24|The population analyzed included all randomized, treated participants who had serum phosphate data at Baseline and Month 24 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history.||Percent Change||95% Confidence Interval|Least Squares Mean
791328|NCT00885170|Secondary|Percent Change From Baseline in Log-Transformed Serum Calcium at Month 24|Serum calcium is an index of calcium homeostasis.|Baseline and Month 24|The population analyzed included all randomized, treated participants who had serum calcium data at Baseline and Month 24 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history.||Percent Change||95% Confidence Interval|Least Squares Mean
791329|NCT00885170|Secondary|Percent Change From Baseline in Log-Transformed Serum N-terminal Propeptide of Type I Collagen at Month 12|s-P1NP is a biochemical marker of bone formation.|Baseline and Month 12|The population analyzed included all randomized, treated participants who had S-P1NP data at Baseline and Month 12 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history.||Percent change||95% Confidence Interval|Least Squares Mean
791330|NCT00885170|Secondary|Percent Change From Baseline in Log-Transformed Serum N-Terminal Propeptide of Type I Collagen at Month 24|Serum N-terminal propeptide of Type I collagen (s-P1NP) is a biochemical marker of bone formation.|Baseline and Month 24|The population analyzed included all randomized, treated participants who had S-P1NP data at Baseline and Month 24 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history.||Percent change||95% Confidence Interval|Least Squares Mean
791331|NCT00885170|Secondary|Percent Change From Baseline in Log-Transformed Serum BSAP at Month 12|BSAP is a biochemical marker of bone formation.|Baseline and Month 12|The population analyzed included all randomized, treated participants who had BSAP data at Baseline and Month 12 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history.||Percent change||95% Confidence Interval|Least Squares Mean
791332|NCT00885170|Secondary|Percent Change From Baseline in Log-Transformed Serum Bone-Specific Alkaline Phosphatase at Month 24|Bone-Specific Alkaline Phosphatase (BSAP) is a biochemical marker of bone formation.|Baseline and Month 24|The population analyzed included all randomized, treated participants who had BSAP data at Baseline and Month 24 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history.||Percent change||95% Confidence Interval|Least Squares Mean
791333|NCT00885170|Secondary|Percent Change From Baseline in Log-Transformed u-NTx/Cr at Month 12|u-NTx/Cr is a biochemical marker of bone resorption.|Baseline and Month 12|The population analyzed included all randomized, treated participants who had u-NTx/Cr data at Baseline and Month 12 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history.||Percent change||95% Confidence Interval|Least Squares Mean
791334|NCT00885170|Secondary|Percent Change From Baseline in Log-Transformed Urine N-Telopeptides/Creatinine Ratio at Month 24|N-Telopeptides of Type 1 Collagen to Urine Creatinine Ratio (u-NTx/Cr) is a biochemical marker of bone resorption.|Baseline and Month 24|The population analyzed included all randomized, treated participants who had u-NTx/Cr data at Baseline and Month 24 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history.||Percent change||95% Confidence Interval|Least Squares Mean
791335|NCT00885170|Secondary|Percent Change From Baseline in Log-Transformed s-CTx at Month 12|s-CTx is a biochemical marker of bone resorption.|Baseline and Month 12|The population analyzed included all randomized, treated participants who had s-CTx data at Baseline and Month 12 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history.||Percent change||95% Confidence Interval|Least Squares Mean
791336|NCT00885170|Secondary|Percent Change From Baseline in Log-Transformed Serum C-Telopeptides of Type I Collagen (s-CTx) at Month 24|s-CTx is a biochemical marker of bone resorption.|Baseline and Month 24|The population analyzed included all randomized, treated participants who had s-CTx data at Baseline and Month 24 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history.||Percent change||95% Confidence Interval|Least Squares Mean
791337|NCT00885170|Secondary|Percent Change From Baseline in 1/3 Distal Forearm BMD at Month 12|BMD at the 1/3 distal forearm was assessed by DXA at baseline and Month 12.|Baseline and 12 Months|The population analyzed included all randomized, treated participants who had 1/3 distal forearm BMD data at Baseline and Month 12.||Percent Change||95% Confidence Interval|Least Squares Mean
791338|NCT00885170|Secondary|Percent Change From Baseline in 1/3 Distal Forearm BMD at Month 24|BMD at the 1/3 distal forearm was assessed by DXA at baseline and Month 24.|Baseline and 24 Months|The population analyzed included all randomized, treated participants who had 1/3 distal forearm BMD data at Baseline and Month 24.||Percent Change||95% Confidence Interval|Least Squares Mean
791339|NCT00885170|Secondary|Percent Change From Baseline in Lumbar Spine BMD at Month 12|BMD at the lumbar spine was assessed by DXA at baseline and Month 12.|Baseline and 12 Months|The population analyzed included all randomized, treated participants who had lumbar spine BMD data at Baseline and Month 12.||Percent Change||95% Confidence Interval|Least Squares Mean
791340|NCT00885170|Secondary|Percent Change From Baseline in Lumbar Spine BMD at Month 24|BMD at the lumbar spine was assessed by DXA at baseline and Month 24.|Baseline and 24 Months|The population analyzed included all randomized, treated participants who had lumbar spine BMD data at Baseline and Month 24.||Percent Change||95% Confidence Interval|Least Squares Mean
791341|NCT00885170|Secondary|Percent Change From Baseline in Total Hip BMD at Month 12|BMD at the total hip was assessed by DXA at baseline and Month 12.|Baseline and 12 Months|The population analyzed included all randomized, treated participants who had total hip BMD data at Baseline and Month 12.||Percent Change||95% Confidence Interval|Least Squares Mean
791342|NCT00885170|Secondary|Percent Change From Baseline in Total Hip BMD at Month 24|BMD at the total hip was assessed by DXA at baseline and Month 24.|Baseline and 24 Months|The population analyzed included all randomized, treated participants who had total hip BMD data at Baseline and Month 24.||Percent Change||95% Confidence Interval|Least Squares Mean
791343|NCT00885170|Secondary|Percent Change From Baseline in Trochanter BMD at Month 12|BMD at the trochanter was assessed by DXA at baseline and Month 12.|Baseline and 12 Months|The population analyzed included all randomized, treated participants who had trochanter BMD data at Baseline and Month 12.||Percent Change||95% Confidence Interval|Least Squares Mean
791344|NCT00885170|Secondary|Percent Change From Baseline in Trochanter BMD at Month 24|BMD at the trochanter was assessed by DXA at baseline and Month 24.|Baseline and 24 Months|The population analyzed included all randomized, treated participants who had trochanter BMD data at Baseline and Month 24.||Percent Change||95% Confidence Interval|Least Squares Mean
791345|NCT00885170|Secondary|Percent Change From Baseline in Femoral Neck BMD at Month 12|BMD at the femoral neck was assessed by DXA at baseline and Month 12.|Baseline and 12 Months|The population analyzed included all randomized, treated participants who had femoral neck BMD data at Baseline and Month 12.||Percent Change||95% Confidence Interval|Least Squares Mean
791346|NCT00885170|Primary|Percentage of Participants Discontinuing Study Drug Due to an AE|An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study.|Up to 24 months|The population analyzed included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.||Percentage of participants|||Number
791347|NCT00885170|Primary|Percentage of Participants Experiencing One or More Adverse Events (AEs)|An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study.|Up to 25 months|The population analyzed included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.||Percentage of participants|||Number
791348|NCT00885170|Primary|Percent Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at Month 24|BMD at the femoral neck was assessed by dual-energy X-ray absorptiometry (DXA) at baseline and Month 24.|Baseline and Month 24|The population analyzed included all randomized, treated participants who had femoral neck BMD data at Baseline and Month 24.||Percent Change||95% Confidence Interval|Least Squares Mean
791349|NCT00885352|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26|Change from baseline reflects the Week 26 value minus the baseline value.|Baseline and Week 26|Full analysis set excluded participants without baseline or post-baseline data. Full analysis set with last observation carried forward.||mg/dL||95% Confidence Interval|Least Squares Mean
791350|NCT00885352|Secondary|Change From Baseline in 2-Hour Post-Meal Glucose (PMG) at Week 26|Change from baseline reflects the Week 26 value minus the baseline value.|Baseline and Week 26|Full analysis set excluded participants without baseline or post-baseline data. Full analysis set with last observation carried forward.||mg/dL||95% Confidence Interval|Least Squares Mean
791351|NCT00885352|Primary|Change From Baseline in Hemoglobin A1c (A1C) at Week 26|Change from baseline reflects the Week 26 value minus the baseline value. A1C represents the percentage of glycosylated hemoglobin.|Baseline and Week 26|Full analysis set excluded participants without baseline or post-baseline data. Full analysis set with last observation carried forward.||Percent of glycosylated hemoglobin||95% Confidence Interval|Least Squares Mean
791352|NCT00885365|Secondary|Participants With a Hearing Threshold >20 Decibel in at Least One Ear|The potential ototoxic effects (hearing loss) of tobramycin were investigated by performing audiometric tests. Participants with a loss of auditory acuity greater than the 20 decibels auditory threshold are reported.|Day -10 to -1 (screening), Weeks 4 and 8|Safety population||percentage of participants|||Number
791353|NCT00885365|Secondary|Count of Participants With Treatment-Emergent Adverse Events (TEAEs)|"Treatment-Emergent Adverse Events defined as adverse events occurring after the first intake of study treatment (or the same day).
The investigator assessed relation to study treatment as a binary question: Reasonable possibility of relatedness or no reasonable possibility of relatedness. The expression “reasonable possibility of relatedness” is meant to convey in general that there are facts (evidence) or arguments meant to suggest a causal relationship.
A serious AE results in death, is life-threatening, requires hospitalization or prolongation of existing inpatient hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or an important medical event.
The investigator rates the severity of the AE based on a three point scale: mild, moderate or severe. A severe event prevents any usual routine activity of the participant and causes severe discomfort."|Day 0 to Week 8|Safety population: all randomised patients who took at least one dose of study medication||percentage of participants|||Number
791354|NCT00885365|Secondary|Change From Baseline to End of Weeks 2, 4 and 8 in Body Mass Index (BMI)||Day 0 (baseline), Weeks 2, 4 and 8|Intent-to-Treat (ITT) Population, observed values. Two participants from both treatment arms were missing data at Week 4. Three participants from Bramitob and 4 participants from TOBI were missing data at Week 8.||kilograms/meters^2||Standard Deviation|Mean
791355|NCT00885365|Secondary|Change From Baseline to End of Weeks 2, 4 and 8 in Body Weight|Body weight was measured at all study visits as part of the physical examination.|Day 0 (baseline), Weeks 2, 4 and 8|Intent-to-Treat (ITT) Population, observed values. Two participants from both treatment arms were missing data at Week 4. Three participants from Bramitob and 4 participants from TOBI were missing data at Week 8.||kilograms||Standard Deviation|Mean
791356|NCT00885365|Secondary|Microbiological Outcome Summary by Visit|"Microbiological outcomes are derived considering all P. aeruginosa (PA) morphotypes together.
Week 4 and Week 8 microbiological outcomes:
Eradication = elimination of PA
Persistence = persistence of PA detected at previous visit
Superinfection = appearance of a pathogen (other than PA) not detected at previous visit
Re-infection (week 8 only) = re-appearance of PA detected at Screening and eradicated at Week 4
Superinfection supersedes eradication. Persistence for P. aeruginosa supersedes superinfection.
Re-infection for P. aeruginosa supersedes superinfection."|Day -10 to -1 (screening), Weeks 4 and 8|Intent-to-Treat Population.||percentage of participants|||Number
791357|NCT00885365|Secondary|Minimal Inhibitory Concentration Inhibiting Growth of 90% (MIC90) of Pseudomonas Aeruginosa|"MIC90 is the concentration of tobramycin required to inhibit 90% of Pseudomonas aeruginosa. MIC values were calculated for three different Pseudomonas aeruginosa (PA) strains:
Morphotype 1: mucoid
Morphotype 2: dry
Morphotype 3: variant
Overall MIC90 values are reported. If a participant has more than one PA morphotype at a given visit, then the highest tobramycin MIC value was used, regardless of PA morphotype. If a participant has more than one available result for each morphotype then the highest tobramycin MIC value was used. If the tobramycin MIC values are equal then the MIC value for the isolate with the highest bacterial load value was used."|Week 4, Week 8|Intent-to-Treat (ITT) Population||micrograms/milliliters|||Number
791358|NCT00885365|Secondary|Minimal Inhibitory Concentration Inhibiting Growth of 50% (MIC50) of Pseudomonas Aeruginosa|"MIC50 is the concentration of tobramycin required to inhibit 50% of Pseudomonas aeruginosa. MIC values were calculated for three different Pseudomonas aeruginosa (PA) strains:
Morphotype 1: mucoid
Morphotype 2: dry
Morphotype 3: variant
Overall MIC50 values are reported. If a participant has more than one PA morphotype at a given visit, then the highest tobramycin MIC value was used, regardless of PA morphotype. If a participant has more than one available result for each morphotype then the highest tobramycin MIC value was used. If the tobramycin MIC values are equal then the MIC value for the isolate with the highest bacterial load value was used."|Week 4, Week 8|Intent-to-Treat (ITT) Population||micrograms/milliliters|||Number
791359|NCT00885365|Secondary|Change From Baseline to End of Weeks 4 and 8 in Pseudomonas Aeruginosa Log10 Bacterial Load in Sputum|If a participant had more than one Pseudomonas aeruginosa (PA) morphotype at a given visit, and therefore more than one bacterial load value, then the bacterial load value corresponding to the highest tobramycin minimal inhibitory concentration (MIC) value regardless of the PA morphotype was used. If the tobramycin MIC value was the same for different PA morphotypes, then the bacterial load value corresponding to morphotype 1 (mucoid colony) was used. If morphotype 1 was not available, bacterial load value corresponding to morphotype 2 (dry colony) was used.|Day -10 to -1 (baseline), Week 4, Week 8|Intent-to-Treat (ITT) Population; At Week 4, six Bramitob patients and seven TOBI patients were missing sputum samples. At Week 8, 11 Bramitob patients and 16 TOBI patients were missing sputum samples.||colony forming units/gram||Standard Deviation|Mean
791360|NCT00885365|Secondary|Change From Baseline to End of Weeks 2, 4, and 8 of Forced Expiratory Flow at 25-75% of Vital Capacity (FEF 25-75%)|Difference in the forced expiratory flow rate in mid-exhalation measured from baseline to weeks 2 (treated), 4 (treated), and 8 (untreated).|Day 0 (baseline), Week 2, Week 4, Week 8|Intent-to-Treat (ITT) Population, observed values. Differences in number of participants analyzed to the ITT population represent participants who missed visits, or failed to take the FEF 25-75% test.||liters/second||Standard Deviation|Mean
791361|NCT00885365|Secondary|Change From Baseline to End of Weeks 2, 4, and 8 of Forced Expiratory Flow at 25-75% of Vital Capacity (FEF 25-75%), Expressed as Percentage of Predicted Normal|Difference in the forced expiratory flow rate in mid-exhalation as a percent of predicted to standard values measured from baseline to weeks 2 (treated), 4 (treated), and 8 (untreated). Because this study included both adults and children and lung volume is an age-dependent variable, reference normal FEF 25-75% values for children were different than the reference normal values used with adult participants.|Day 0 (baseline), Week 2, Week 4, Week 8|Intent-to-Treat (ITT) Population, observed values. Differences in number of participants analyzed to the ITT population represent participants who missed visits, or failed to take the FEF 25-75% test.||percentage predicted FEF 25-75%||Standard Deviation|Mean
791362|NCT00885365|Secondary|Change From Baseline to End of Weeks 2, 4, and 8 of Absolute Forced Vital Capacity (FVC)|FVC is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. It is measured via spirometry.|Day 0 (baseline), Week 2, Week 4, Week 8|Intent-to-Treat (ITT) Population, observed values. Differences in number of participants analyzed to the ITT population represent participants who missed visits, or failed to take the FVC test.||liters||Standard Deviation|Mean
791363|NCT00885365|Secondary|Change From Baseline at End of Weeks 2, 4, and 8 of Forced Vital Capacity (FVC) Expressed as Percentage of Predicted Normal|FVC is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. It is measured via spirometry. Because this study included both adults and children and lung volume is an age-dependent variable, reference normal FVC values for children were different than the reference normal values used with adult participants.|Day 0 (baseline), Week 2, Week 4, Week 8|Intent-to-Treat (ITT) Population, observed values. Differences in number of participants analyzed to the ITT population represent participants who missed visits, or failed to take the FVC test.||percentage predicted FVC||Standard Deviation|Mean
791364|NCT00885365|Secondary|Change From Baseline to End of Weeks 2, 4, and 8 of Absolute Forced Expiratory Volume in 1 Second (FEV1)|Pulmonary function measurements were performed by using a self-calibrated computer-operated pneumotochographic spirometer at all clinic visits. Three measurements were collected and the greatest FEV1 value was recorded. Observed values are summarized (without last observation carry forward).|Day 0 (baseline), Week 2, Week 4, Week 8|Intent-to-Treat (ITT) Population, observed values. Differences in number of participants analyzed to the ITT population represent participants who missed visits, or failed to take the FEV1 test.||liters||Standard Deviation|Mean
791377|NCT00885378|Secondary|Percentage of Participants Achieving a Therapeutic Glycemic Response (A1C < 7.0%) at Week 12|Adjusted for baseline. Calculated using the method by Zhang et al. (Zhang M, Tsiatis A, Davidian M. Improving efficiency of inference in randomized clinical trials using auxiliary covariates. Biometrics. Published online on January 11, 2008; Digital Object Identifier: 10.1111/j.1541-0420.2007.00976.x.)|Week 12|Randomized participants with measurement at timepoint with LOCF.||Percentage of Participants||95% Confidence Interval|Number
791365|NCT00885365|Secondary|Change From Baseline to End of Weeks 2, 4, and 8 of Forced Expiratory Volume in 1 Second (FEV1), Expressed as Percentage of Predicted Normal|Pulmonary function measurements were performed by using a self-calibrated computer-operated pneumotochographic spirometer at all clinic visits. Because this study included both adults and children and lung volume is an age-dependent variable, reference normal FEV1 values for children were different than the reference normal values used with adult participants. Three measurements were collected and the greatest FEV1 value was recorded. Observed values are summarized (without last observation carry forward).|Day 0 (baseline), Week 2, Week 4, Week 8|Intent-to-Treat (ITT) Population, observed values. Differences in number of participants analyzed to the ITT population represent participants who missed visits, or failed to take the FEV1 test.||percentage predicted FEV1||Standard Deviation|Mean
791366|NCT00885365|Primary|Change From Baseline to End of the Treatment Period of Forced Expiratory Volume in 1 Second (FEV1), Expressed as Percentage of Predicted Normal|Pulmonary function measurements were performed by using a self-calibrated computer-operated pneumotochographic spirometer at all clinic visits. Because this study included both adults and children and lung volume is an age-dependent variable, reference normal FEV1 values for children were different than the reference normal values used with adult participants. Three measurements were collected and the greatest FEV1 value was recorded.|Day 0 (baseline), Week 4|Intent-to-Treat (ITT) Population, Last Observation Carried Forward (LOCF)||percentage predicted FEV1||Standard Deviation|Mean
791367|NCT00885378|Other Pre-specified|Participants Experiencing Changes From Baseline in Urinalysis Parameters That Met the Marked Abnormality Criteria|Marked abnormality criteria were urine protein: if pre-Rx=o use >=2, if pre-Rx =0.5 or 1 use >=3, if pre-Rx =2, use >=4; urine blood: if pre-Rx=0, use >=2, if pre-Rx=0.5 or 1, use >=3, if pre-Rx=2, use >=4; Urine red blood cell count (RBC): if pre-Rx=o use >=2, if pre-Rx =0.5 or 1 use >=3, if pre-Rx =2, use >=4; urine white blood cell count (WBC): if pre-Rx=o use >=2, if pre-Rx =0.5 or 1 use >=3, if pre-Rx =2, use >=4.|Baseline, Week 12|All treated participants. N = number of participants analyzed and n = the number of participants with values available for each specific measurement.||Participants|||Number
791368|NCT00885378|Other Pre-specified|Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria|A laboratory value was considered a marked abnormality if it is outside the pre-defined criteria for marked abnormality and the on-treatment value was more extreme (farther from the limit) than the baseline value. ULN=upper limit of normal; LLN=lower limit of normal.|Baseline, Week 12|All treated participants.||Participants|||Number
791369|NCT00885378|Primary|Mean Hemoglobin A1C (A1c) and Change From Baseline to Week 12|Mean change was adjusted for baseline.|Baseline, Week 12|Randomized participants with both a baseline value and post-baseline value (up to Week 12).||Percentage of glycosylated hemoglobins||Standard Error|Mean
791370|NCT00885378|Other Pre-specified|Baseline and Mean Change From Baseline in Participant Heart Rate (HR)|Baseline values reference the measurement for the cohort of participants evaluated at the given time point.|Baseline, Week 4, Week 8, Week 12|All treated participants. n= number of participants with measurement at time point.||mm Hg||Standard Error|Mean
791371|NCT00885378|Other Pre-specified|Baseline and Mean Change From Baseline in Participant Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Baseline values reference the measurement for the cohort of participants evaluated at the given time point.|Baseline, Week 4, Week 8, Week 12|All treated participants. n= number of participants with measurement at time point.||mm Hg||Standard Error|Mean
791372|NCT00885378|Other Pre-specified|Participant Electrocardiogram (ECG) Status at Baseline and Week 12|Abnormal ECGs were defined as those not within the normal limits for the participant, according to the investigator. 'Shifted Normal to Abnormal' and 'Shifted Abnormal to Normal' references a change from measurements at Baseline to those at Week 12.|Baseline, Week 12|All treated participants, excluding those with missing values.||Participants|||Number
791373|NCT00885378|Other Pre-specified|Participants With Confirmed Hypoglycemia|Confirmed hypoglycemia was defined by a fingerstick glucose value <= 50 mg/dL with associated hypoglycemia symptoms.|Week 1 to Week 12; AEs are included up to the last treatment day + 1 day or the last visit in the DB period. SAEs are included up to the last of 1) the last treatment day + 30 days or 2) the last visit day + 30 days in the DB period.|All treated participants.||Participants|||Number
791374|NCT00885378|Other Pre-specified|Participants With Reported Hypoglycemia AEs During Double-Blind Treatment Period|Hypoglycemic Events are based upon the Saxagliptin Predefined List of Events, which included hypoglycemia, blood glucose decreased, and hypoglycemic unconsciousness.|Week 1 to Week 12; AEs are included up to the last treatment day + 1 day or the last visit in the DB period. SAEs are included up to the last of 1) the last treatment day + 30 days or 2) the last visit day + 30 days in the DB period.|All treated participants.||Participants|||Number
791375|NCT00885378|Other Pre-specified|Participant Adverse Event (AE), Related AE, Serious Adverse Event (SAE), Related SAE, and Discontinued Due to AEs Summary|AE = any new untoward medical occurrence/worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment.SAE = any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Treatment-related=Possible, Probable, or Certain relationship to drug.|Week 1 to Week 12; AEs are included up to the last treatment day + 1 day or the last visit in the double-blind (DB) period. SAEs are included up to the last of 1) the last treatment day + 30 days or 2) the last visit day + 30 days in the DB period.|All treated participants.||Participants|||Number
791376|NCT00885378|Secondary|Percentage of Participants Achieving a Therapeutic Glycemic Response (A1C <= 6.5%) at Week 12|Adjusted for baseline. Calculated using the method by Zhang et al. (Zhang M, Tsiatis A, Davidian M. Improving efficiency of inference in randomized clinical trials using auxiliary covariates. Biometrics. Published online on January 11, 2008; Digital Object Identifier: 10.1111/j.1541-0420.2007.00976.x.)|Week 12|Randomized participants with measurement at timepoint with LOCF.||Percentage of Participants||95% Confidence Interval|Number
791378|NCT00885378|Secondary|Mean Baseline and Change From Baseline in Fasting Plasma Glucose (FPG)|Mean change was adjusted for baseline.|Baseline, Week 12|Randomized participants with a measurement at the specified timepoint with Last Observation Carried Forward (LOCF).||mg / dL||Standard Error|Mean
791379|NCT00885482|Secondary|Change of Bone Density and of Subcutaneous Fat at 48 Weeks||48 weeks||||||
791388|NCT00885534|Primary|Overall Response to CVT Chemotherapy.|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|2 years|||participants|||Number
791389|NCT00885638|Secondary|Insulin Secretion After Ingestion of Meal|Plasma insulin levels will be measured during 300 min after meal ingestion to estimation of insulin secretion|300 min|Completer population||mol/l/min||Standard Error|Mean
791390|NCT00885638|Primary|Glucagon-like Peptide-1 Secretion After Meal Ingestion|Plasma GLP-1 levels will be measured during 300 min after meal ingestion for estimation of GLP-1 secretion|300 min|Completer population||nmol/l/min||Standard Error|Mean
791391|NCT00885677|Primary|Phase 2: Combined Endpoint of Death From Any Cause, Cardiovascular and Device-related Hospitalizations (at Least 48 Hours Stay), Calculated as Number of Subjects With at Least One Event|Time to first event|2 years after randomization|All subjects in analysis were included in the primary endpoint analysis||participants|||Number
791392|NCT00885677|Primary|Phase 1: Median Time Between Event Onset Time and Clinical Decision for Each Subject.|The median delay from device-detected events to clinical decisions was considerably shorter in the Remote group compared to the Control group|1 year since the randomization|Phase 1: A total of 154 patients were enrolled from May 2009 through April 2010 from 32 centers in 6 different countries (France, Hungary, Israel, Italy, Spain, and Switzerland). The final patient cohort object of analysis comprised 148 patients (76 in the Remote group and 72 in the Control group)||days||Inter-Quartile Range|Median
791393|NCT00885742|Secondary|Achievement of Trough Factor XIII Levels of 5% or Higher.|Number of subjects with Factor XIII level ≥ 5% before infusion at Week 12, Week 24, Week 36 and Week 48.|At 12, 24, 36 and 48 weeks: immediately before infusion.|The Efficacy Population comprised all subjects who received a dose of FXIII Concentrate (Human) during the study and included those who were assessed for efficacy at Baseline and had at least 1 follow-up FXIII activity trough level.||participants|||Number
791394|NCT00885742|Secondary|Incremental Recovery|Incremental recovery (U/mL/U/kg) is defined as maximum (peak) FXIII activity (U/mL) obtained after infusion, per dose of (U/kg) infusion.|At 12, 24, 36 and 48 weeks: immediately before infusion, then at 30 and 60 minutes after the end of the infusion.|The Pharmacokinetic (PK) Population comprised all subjects who received a dose of FXIII Concentrate (Human) during the study and included those who completed the study (defined as having sufficient bioanalytical assessments to calculate reliable estimates of the PK parameters).||Units/mL/Units/kg||Standard Deviation|Mean
791395|NCT00885742|Secondary|Time to Peak Concentration||At 12, 24, 36 and 48 weeks: immediately before infusion, then at 30 and 60 minutes after the end of the infusion.|The Pharmacokinetic (PK) Population comprised all subjects who received a dose of FXIII Concentrate (Human) during the study and included those who completed the study (defined as having sufficient bioanalytical assessments to calculate reliable estimates of the PK parameters).||Hour||Standard Deviation|Mean
791396|NCT00885742|Secondary|Trough FXIII Concentration at Steady State||At 12, 24, 36 and 48 weeks: immediately before infusion.|The Pharmacokinetic (PK) Population comprised all subjects who received a dose of FXIII Concentrate (Human) during the study and included those who completed the study (defined as having sufficient bioanalytical assessments to calculate reliable estimates of the PK parameters).||Units/mL||Standard Deviation|Mean
791397|NCT00885742|Secondary|Peak FXIII Concentration at Steady State||At 12, 24, 36 and 48 weeks: at 30 and 60 minutes after the end of the infusion.|The Pharmacokinetic (PK) Population comprised all subjects who received a dose of FXIII Concentrate (Human) during the study and included those who completed the study (defined as having sufficient bioanalytical assessments to calculate reliable estimates of the PK parameters).||Units/mL||Standard Deviation|Mean
791398|NCT00885742|Secondary|Adverse Events|Number of subjects with any treatment-emergent adverse event (AE), treatment-related AE or serious AE (SAE). Treatment related AEs are defined as AEs whose relationship to study treatment is related, or possibly related, and AEs with missing relationship.|12 months|The Safety Population comprised all subjects who received a dose of FXIII Concentrate (Human) during the study.||participants|||Number
791399|NCT00885742|Secondary|Association of the Incidence of Spontaneous Bleeding Events Requiring Treatment and FXIII Activity Trough Levels|P-value determined from Generalized Estimating Equation (GEE) model parameter estimates with bleeding as the response variable and FXIII activity trough level as the explanatory variable.|12 months|The analysis population comprised those subjects with spontaneous bleeding events requiring treatment with a FXIII-containing product. Note: no subjects had spontaneous bleeding events requiring treatment with a FXIII-containing product, so no subjects were analyzed.||participants|||Number
791400|NCT00885742|Primary|The Incidence of Spontaneous Bleeding Events Requiring Treatment (Treatment is Defined as Administration of a FXIII‑Containing Product to Treat the Bleeding Event)|The number of subjects requiring treatment with a Factor XIII-containing product to treat a spontaneous bleeding event.|Up to week 52|The Efficacy Population comprised all subjects who received a dose of FXIII Concentrate (Human) during the study and included those who were assessed for efficacy at Baseline and had at least 1 follow-up FXIII activity trough level.||participants|||Number
791401|NCT00885755|Secondary|Part I and II: Percentage of Participants With a Response by Best Overall Response by CR, PR, SD or PD in ITT Population|Best Overall response was defined according to RECIST. CR: disappearance of all target lesions and all pathological lymph nodes below 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions.|End of first 2 Cycles (Weeks 3 and 6), every 3 cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 months|ITT population; n = number of participants analyzed for the specified category.||percentage of participants|||Number
791442|NCT00886483|Primary|Necessary Duration of Treatment|The necessary duration of treatments was examined via identifying the number of treatments at which improvement stabilized, as shown visually on graphs of parent-rated ADHD symptoms from the SNAP-IV (0-3 scale, lower score is better) for those participants in the Active Neurofeedback who completed 40 treatment sessions.The Sham group is not included in this outcome.|40 treatment sessions ~ 13-20 weeks|Number of participants in active (n=24) and sham (n=10) neurofeedback completing 40 treatments.||units on a scale||Standard Deviation|Mean
791402|NCT00885755|Primary|Part II: Percentage of Participants With a Best Overall Response of CR, PR, SD or PD by Biomarker|Best Overall response was defined according to RECIST. CR: disappearance of all target lesions and all pathological lymph nodes below 10 mm.PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions. The relationship between best response and the following biomarkers was investigated: p95 HER2 (+ve/-ve), IGF1R, c-MET, PTEN, HER2 (<median/≥median) , PI3K catalytic subunit (WT/M), and FC gamma receptors IIIa, IIa and IIb (phenotypes FF, VF, VV, HH, HR, RR and II, IT and TT respectively). The correlation between the biomarker variables and percentage of participants with best response were investigated using a univariate regression analysis.|End of first 2 Cycles (Weeks 3 and 6), every 3 cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 months|PP population; n = number of participants with biomarker data available for the specified biomarker. Data are reported for Group A only as there were no evaluable participants in Group B.||percentage of participants|||Number
791403|NCT00885755|Primary|Part I: Percentage of Participants With a Best Overall Response (BOR) of Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progrerssive Disease (PD) by Biomarker|BOR was defined according to the Response Evaluation Criteria In Solid Tumors (RECIST). CR: disappearance of all target lesions and all pathological lymph nodes below 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions. The relationship between best response and the following biomarkers was investigated: p95 HER2 (+ve/-ve), IGF1R, c-MET, PTEN, HER2 (median/≥median), PI3K catalytic subunit (WT/M), and FC gamma receptors IIIa, IIa and IIb (phenotypes FF, VF, VV, HH, HR, RR and II, IT and TT respectively). The correlation between the biomarker variables and percentage of participants with best response were investigated using a univariate regression analysis.|End of first 2 Cycles (Weeks 3 and 6), every 3 cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 weeks|PP population; n = number of participants with biomarker data available for the specified biomarker. Data are reported for Group A only as there were no evaluable participants in Group B.||percentage of participants|||Number
791404|NCT00885755|Primary|Part II: TTP by Biomarker|TTP was calculated from first study medication in Part II to date of progression. The relationship between TTP and the following biomarker variables was investigated in each of study Part 1 and 2: p95 HER2 +ve and -ve population, IGF1R <median and ≥median, c-MET <median and ≥median, PTEN <median and ≥median, HER2 <median and ≥median, PI3K catalytic subunit WT and M, and FC gamma receptors IIIa, IIa and IIb Phenotypes FF, VF and VV, HH, HR and RR, and II, IT and TT .|End of first 2 Cycles (Weeks 3 and 6), every 3 cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 months|PP population; n = number of participants with biomarker data available for the specified biomarker.||months||95% Confidence Interval|Median
791405|NCT00885755|Secondary|Part I and II: Percentage of Participants With a Best Overall Response of CR or PR in ITT Population|Best Overall response was defined according to RECIST. CR: disappearance of all target lesions and all pathological lymph nodes below 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions.|End of first 2 Cycles (Weeks 3 and 6), every 3 Cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 months|ITT population; n = number of participants analyzed for the specified category.||percentage of participants|||Number
791406|NCT00885755|Secondary|Overall Survival in ITT Population|Overall survival was calculated in months from the day of screening until death.|End of first 2 Cycles (Weeks 3 and 6), every 3 cycles for 18 weeks, then every 4 cycles until death (up to 46 months)|ITT population||months||Full Range|Median
791407|NCT00885755|Secondary|Overall Survival in Per Protocol Population|Overall survival was calculated in months from the day of screening until death.|End of first 2 Cycles (Weeks 3 and 6), every 3 cycles for 18 weeks, then every 4 cycles until death (up to 46 months)|PP population||months||Full Range|Median
791408|NCT00885755|Secondary|Part II: PFS in ITT Population|PFS was calculated from first study medication in Part II to date of progression or death. In participants with measurable disease progression was defined according to RECIST (SLD increased by at least 20% from the smallest value on study [including baseline, if that is the smallest]). In participants with non-measurable disease, progression was defined as the presence of new lesions or unequivocal progression during treatment.|End of first 2 Cycles (Weeks 3 and 6), every 3 cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 months|ITT population; Participant from Group B and from No group were not included in this analysis.||months||95% Confidence Interval|Median
791409|NCT00885755|Secondary|Part II: TTP in Intent to Treat (ITT) Population|TTP was calculated from first study medication in Part II to date of progression. In participants with measurable disease progression was defined according to RECIST(SLD increased by at least 20% from the smallest value on study [including baseline, if that is the smallest]). In participants with non-measurable disease, progression was defined as the presence of new lesions or unequivocal progression during treatment.|End of first 2 Cycles (Weeks 3 and 6), every 3 Cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 months|ITT population; Participant from Group B and from No group were not included in this analysis.||months||95% Confidence Interval|Median
791443|NCT00886483|Primary|Frequency Advisability Outcome (2X vs. 3X/wk) #2. Treatment Frequency Choice|Treatment frequency preference when given choice to change or not to change treatment frequency from 2 to 3X/wk or 3 to 2X/wk at treatment # 24.|24 treatments ~ 8-12 weeks|participants completing treatment 24||percentage of participants|||Number
791410|NCT00885755|Secondary|Part I: PFS in ITT Population|PFS was determined as the time in months from the date of screening until first progression. In participants with measurable disease, progression was defined according to RECIST (SLD increased by at least 20% from the smallest value on study [including baseline, if that is the smallest]).. In participants with non-measurable disease, progression was defined as the presence of new lesions or unequivocal progression during treatment.|End of first 2 Cycles (Weeks 3 and 6), every 3 cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 months|ITT population; Participant from Group B and from No group were not included in this analysis.||months||95% Confidence Interval|Median
791411|NCT00885755|Primary|Part I: Time to Progression (TTP) by Biomarker|Progression was defined as an increase by at least 20% from the smallest value in the SLD of lesions.TTP was determined as the time in months from the date of screening until first progression.The relationship between PFS and the following biomarker variables was investigated in each of study Part 1 and 2: p95 HER2 +ve and -ve population, IGF1R <median and ≥median, c-MET <median and ≥median, PTEN <median and ≥median, HER2 <median and ≥median, PI3K catalytic subunit WT and M, and FC gamma receptors IIIa, IIa and IIb Phenotypes FF, VF and VV, HH, HR and RR, and II, IT and TT . The correlation between the biomarker variables and TTP were investigated using a univariate Cox regression model and time-to-event methods (Kaplan-Meier).|End of first 2 Cycles (Weeks 3 and 6), every 3 Cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 weeks|PP population; n = number of participants with biomarker data available for the specified biomarker.||months||95% Confidence Interval|Median
791412|NCT00885755|Primary|Part II: Progression Free Survival (PFS) by Biomarker|PFS was calculated from first study medication in Part II to date of progression or death.The relationship between PFS and the following biomarker variables was investigated in each of study Part 1 and 2: p95HER2 +ve and -ve population, IGF1R <median and ≥ median membrane H score, c-MET <median and ≥median membrane H score, PTEN <median and ≥median cytoplasm H score, HER2 <median and ≥median membrane H score, PI3K catalytic subunit WT and M, and FC gamma receptors IIIa, IIa and IIb Phenotypes FF, VF and VV, HH, HR and RR, and II, IT and TT.|End of first 2 Cycles (Weeks 3 and 6), every 3 cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 months|PP population; n = number of participants with biomarker data available for the specified biomarker.||months||95% Confidence Interval|Median
791413|NCT00885755|Secondary|Part I: TTP in Intent to Treat (ITT) Population|TTP was determined as the time in months from the date of screening until first progression. In participants with measurable disease, progression was defined according to RECIST (SLD increased by at least 20% from the smallest value on study [including baseline, if that is the smallest]). In participants with non-measurable disease, progression was defined as the presence of new lesions or unequivocal progression during treatment.|End of first 2 Cycles (Weeks 3 and 6), every 3 cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 months|ITT population; Participant from Group B and from No group were not included in this analysis.||months||95% Confidence Interval|Median
791414|NCT00885755|Primary|Part I: Progression Free Survival (PFS) by Biomarker|Progression was defined as an increase by at least 20 percent (%) from the smallest value in the Sum of Longest Diameter (SLD) of lesions. Biomarkers investigated: p95 human epidermal growth factor receptor 2 (p95HER2) positive (+ve) and negative (-ve) , insulin growth factor-1 receptor (IGF1R) less than (<) median and greater than or equal to (≥) median membrane H score, c-MET <median and ≥median membrane H score, phosphatase and tensin homolog gene (PTEN) <median and ≥median cytoplasm H score, HER2 <median and ≥median membrane H score, phosphatidylinositol-3-kinase (PI3K) catalytic subunit wild type (WT) and mutation (M), and FC gamma receptors IIIa homozygous Phenyl alanine (FF), heterozygous Phenyl alanine/Valine (VF) and homozygous Valine (VV), receptor IIa Phenotypes homozygous Histidine (HH), heterozygous Histidine/Arginine (HR) and homozygous Arginine (RR) IIb phenotypes homozygous Isoleucien (II),heterozygous Isoleucine/Threonine (IT) and homozygous Threonine (TT) .|End of first 2 Cycles (Weeks 3 and 6), every 3 Cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 months|Per Protocol (PP) population included all participants who had received a complete first dose of study medication and had baseline and at least one on-treatment biomarker assessment. Number (n) equals (=) number of participants with biomarker data available for the specified biomarker.||months||95% Confidence Interval|Median
791415|NCT00885768|Primary|The Number of Patients With Renal Artery Stenosis|the prevalence of renal artery stenosis in patients with coronary artery disease|3months|||participants|||Number
791416|NCT00885768|Primary|Prevalence of Renal Artery Stenosis (RAS)||2 months||||||
791417|NCT00885846|Primary|Fasting Blood Glucose||Week 0 (baseline) and week 12 (final)|Analysis performed per protocol. Participants excluded from analysis for changing or discontinuing medication during intervention.||mg/dL||Standard Deviation|Mean
791418|NCT00885846|Secondary|Fasting Cortisol||Weeks 0 and 12||||||
791419|NCT00885846|Secondary|HOMA-IR Index||weeks 0 and 12||||||
791420|NCT00885846|Secondary|Beck's Depression Inventory (BDI)||weeks 0 and 12||||||
791421|NCT00885846|Secondary|Perceived Stress Scale (PSS)||weeks 0 and 12||||||
791422|NCT00885846|Secondary|Fasting Insulin||weeks 0 and 12||||||
791423|NCT00885846|Secondary|Fasting C-peptide||weeks 0 and 12||||||
791424|NCT00886015|Secondary|Number of Eyelids With Normal, Mild, Moderate, or Severe Trachomatous Trichiasis|"Trichiasis is generally defined as 1 or more eyelashes touching globe in primary position. Classifications of trichiasis severity are as follows:
Mild: 1-4 Eyelashes touching globe, no epilation OR 1-10 Eyelashes epilated, no eyelashes touching globe; Moderate: 5-9 Eyelashes touching globe, no epilation OR 1-4 Eyelashes touching globe and 1-10 eyelashes epilated; Severe: 5-9 Eyelashes touching globe and 1-10 eyelashes epilated OR 10 Eyelashes touching globe, regardless of epilation status OR 11-20 Eyelashes epilated, regardless of eyelashes touching globe OR Entire eyelid epilated, regardless of eyelashes touching globe"|2 Years|Of the 1669 TT eyelids and 1674 BLTR eyelids included in the initial analysis, 13 eyes (4 in the TT clamp group, 9 in the BLTR group) without TT at 1 year underwent operation between years 1 and 2. They are not included in the data for severity of recurrence because we do not know the TT severity.||eyelids|eyelids||Number
791425|NCT00886015|Secondary|Number of Eyelids With Mild, Moderate, Severe, or no Eyelid Contour Abnormality|"Eyelid contour abnormalities (ECA) were graded by photographs of the eyes. ECA severity is defined as follows:
Mild: Vertical deviation from the natural contour < 1 mm in height (less than half the pupil height in daylight) and affecting < 1/3 of horizontal eyelid length; Moderate: Vertical deviation from the natural contour 1–2 mm in height (about the pupil height in daylight) or affecting 1/3–2/3 of horizontal eyelid length; Severe: Vertical deviation from the natural contour > 2 mm in height (more than the pupil height in daylight) or a defect > 2/3 of the horizontal eyelid length"|2 years|Of the 1771 participants originally assigned to TT Clamp, 1 participant (2 eyelids) was excluded from TT Clamp analysis because participant died before follow-up||eyelids|eyelids||Number
791426|NCT00886015|Primary|Number of Eyelids With Normal or Mild Eyelid Contour Abnormalities vs Moderate or Severe Eyelid Contour Abnormalities|"Eyelid contour abnormalities (ECA) were graded by photographs of the eyes. In the primary outcome measure, normal eyes and mild eyelid contour abnormalities are considered together, and moderate or severe eyelid contour abnormalities are considered together. ECA severity is defined as follows:
Mild: Vertical deviation from the natural contour < 1 mm in height (less than half the pupil height in daylight) and affecting < 1/3 of horizontal eyelid length; Moderate: Vertical deviation from the natural contour 1–2 mm in height (about the pupil height in daylight) or affecting 1/3–2/3 of horizontal eyelid length; Severe: Vertical deviation from the natural contour > 2 mm in height (more than the pupil height in daylight) or a defect > 2/3 of the horizontal eyelid length"|2 years|Of the original 1771 eyelids assigned to TT clamp, 1 participant (2 eyelids) was excluded from TT Clamp analysis because participant died before follow-up||eyelids|eyelids||Number
791427|NCT00886015|Primary|Number of Eyelids Experiencing an Unfavorable Outcome|At least 1 unfavorable outcome, including mild, moderate, or severe trichiasis; granuloma; or mild, moderate, or severe eyelid contour abnormality|2 years|Of the original 1771 eyelids assigned to TT clamp, 1 participant (2 eyelids) was excluded from TT Clamp analysis because participant died before follow-up||eyelids|eyelids||Number
791428|NCT00886015|Primary|Number of Eyelids With Pyogenic Granuloma|A pyogenic granuloma was defined as a sessile growth of 2 mm or more in diameter on the tarsal conjunctiva.|2 years|Of the original 1771 eyelids assigned to TT clamp, 1 participant (2 eyelids) was excluded from TT Clamp analysis because participant died before follow-up||eyelids|eyelids||Number
791429|NCT00886015|Primary|Number of Eyelids With Presence of Recurrent Trichiasis|Trichiasis: 1 or more eyelashes touching globe in primary position|2 years|Of the 1671 eyes initially assigned to TT Clamp, 1 participant (2 eyelids) was excluded from TT Clamp analysis because participant died before follow-up.||eyelids|eyelids||Number
791430|NCT00886119|Primary|Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity|Tested while reading charts distant to the subject with both eyes together in normal lighting. This outcome is measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 equates to 20/20 Snellen acuity and is considered normal. Positive logMAR values indicate poorer vision and negative values denote better visual acuity.|After 1 week of wear|Per Protocol. Analysis excluded major protocol deviations as determined by masked review.||logMAR||Standard Deviation|Mean
791431|NCT00886145|Primary|Percent Change From Baseline in Volumetric Bone Mineral Density (vBMD) at 6-Months|Volumetric Bone Mineral Density of the Right and Left Distal Tibia as Determined by Peripheral Quantitative Computed Tomography|The Percent Change in vBMD from Baseline to 6 months after Mechanical Stimulation Vibration Therapy|||Percent Change|||Number
791432|NCT00886288|Secondary|Percentage of Patients With Positive to Negative Shift in Albuminuria|Percentage of patients shifting from with (positive) albuminuria at baseline to without (negative) albuminuria after approximately 12 weeks|Approximately 12 weeks (10 to 14 weeks) after baseline|All patients with albuminuria at initial visit and for which information on albuminuria was known at visit 2, 12 weeks after the initial visit.||Percentage of patients||95% Confidence Interval|Number
791433|NCT00886288|Secondary|Percentage of Patients Presenting an Adverse Event (AE)|Percentage of patients with any adverse events during the study period, related or not to investigational drug|baseline to the end of study period|1741 patients had a visit 2 between 10 and 14 weeks after baseline (1284+457)||percentage of patients|||Number
791434|NCT00886288|Secondary|Percentage of Patients With a Decrease of Systolic Blood Pressure (SBP) ≥ 10 mmHg (Responders)|The response in SBP after approximately 12 weeks of treatment including telmisartan defined as a fall in SBP (SBP (baseline) – SBP (12 weeks) ≥ 10 mmHg|approximately 12 weeks (10 to 14 weeks) after baseline|1741 patients had a visit 2 between 10 and 14 weeks after baseline (1284+457)||Percentage of patients|||Number
791435|NCT00886288|Secondary|Mean Difference in Diastolic Blood Pressure|The fall in diastolic blood pressure (DBP) after approximately 12 weeks of treatment including telmisartan defined as DBP (baseline) – DBP (12 weeks) expressed in mmHg|baseline and approximately 12 weeks|1741 patients had a visit 2 between 10 and 14 weeks after baseline (1284+457)||mmHg||Standard Deviation|Mean
791436|NCT00886288|Secondary|Mean Difference in Systolic Blood Pressure|The fall in systolic blood pressure (SBP) after approximately 12 weeks of treatment including telmisartan defined as SBP (baseline) – SBP (12 weeks) expressed in mmHg|baseline and approximately 12 weeks|1741 patients had a visit 2 between 10 and 14 weeks after baseline (1284+457)||mmHg||Standard Deviation|Mean
791437|NCT00886288|Primary|Percentage of Patients With Controlled Blood Pressure|"Systolic blood pressure (SBP) < 140 mmHg and diastolic blood pressure (DBP) < 90 mmHg if the patient has:
no chronic renal insufficiency or macroalbuminuria-dipsticks negative,
albuminuria is < 300 mg/24h or < 200 mg albumin per gram of creatinine
no diabetes
or SBP < 130 mmHg and DBP < 80 mmHg if the patient has:
chronic renal insufficiency or macroalbuminuria-dipsticks are positive, albuminuria ≥ 300 mg/24h or ≥ 200 mg albumin per gram of creatinine
diabetes (type 1 or 2)"|approximately 12 weeks (10 to 14 weeks) after baseline|1741 patients had a visit 2 between 10 and 14 weeks after baseline (1284+457)||Percentage of patients|||Number
791438|NCT00886340|Secondary|Quality of Life||6 months||||||
791439|NCT00886340|Secondary|Lipids||6 months||||||
791440|NCT00886340|Secondary|Diet and Exercise Behavior||6 months||||||
791441|NCT00886340|Primary|Number of Participants Who Met Weight Loss Goal of 5% Weight Loss||6 months|||participants|||Number
791755|NCT00880230|Secondary|Death|Death can be classified as one of three categories: cardiac, vascular, or non-cardiovascular. All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established.|9 Months|Intention to Treat Population (ITT)||Percentage of Patients|||Number
791444|NCT00886483|Primary|Frequency Advisability Outcome (2X vs. 3X/wk) #1 Parent & Child Satisfaction|Parent & child satisfaction of treatment frequency (x2 vs x3 treatments per week) was measured on a likert scale with anchors 0 (indicating low satisfaction) and 7 (indicating high satisfaction).|24 treatments ~ 8-12 weeks|Those completing 24 treatments||units on a scale||Standard Deviation|Mean
791445|NCT00886483|Primary|Feasibility of Double-blind, Sham-controlled Design #3. Validity of Blind|The feasibility of the double-blind, sham-controlled design was examined in 3 ways. The 3rd way was the percentage of child and parent post-hoc guess regarding treatment assignment.|Post-treatment at session 40|Participants in both Active and Sham Neurofeedback completing 40 treatment sessions.||percentage of participants|||Number
791446|NCT00886483|Primary|Feasibility of Double-blind, Sham-controlled Design #2. Retention|The feasibility of the double-blind, sham-controlled design was examined in 3 ways. The second way was via the percentage of participants retained the end of treatment (40th session).|40th treatment sessions ~ 13-20 weeks|Number randomized was denominator for percentage of participants completing 40 treatment sessions.||percentage of participants|||Number
791447|NCT00886483|Primary|Feasibility of Double-blind, Sham-controlled Design #1. Recruitment Number|The feasibility of the double-blind, sham-controlled design was examined in 3 ways, this first way was via the number of participants recruited.|2 years|Based on inclusion & exclusion criteria and randomization in a 2:1 ratio to active NF vs. sham NF.||participants|||Number
791448|NCT00886587|Secondary|Itch Score on Day 43 - Change From Baseline|The subject’s and/or caregiver's assessment of itch was measured on a 10-cm visual analog scale (VAS) in which 0 cm represented no itch and 10 cm represented worst itch imaginable.|Baseline to Day 43|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||units on a scale||Standard Error|Least Squares Mean
791449|NCT00886587|Secondary|Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 43 - Change From Baseline|The signs and symptoms of eczema are measured using the Investigator's Global Atopic Dermatitis Assessment (IGADA), with possible values of clear (0), almost clear (1), mild (2), moderate (3), severe (4), or very severe (5).|Baseline to Day 43|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||units on a scale||Standard Error|Least Squares Mean
791450|NCT00886587|Secondary|Eczema Area and Severity Index (EASI) on Day 15 - Change From Baseline|The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final possible calculation ranging from 0 (none) - 72 (severe).|Baseline to Day 15|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||units on a scale||Standard Error|Least Squares Mean
791451|NCT00886587|Primary|Eczema Area and Severity Index (EASI) Score on Day 43 - Change From Baseline|The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final possible calculation ranging from 0 (none) - 72 (severe).|Baseline to Day 43|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||units on a scale||Standard Error|Least Squares Mean
791452|NCT00886600|Secondary|Mean Change From Week 4 in Sitting Diastolic Blood Pressure (siDBP) Adding HCTZ 24 Hours After Morning Dose at Week 6||Baseline and 24-hours after morning dose at Week 6|"The efficacy analysis followed a per protocol approach in that only patients who completed the study according to the protocol were included in the analysis."||mm Hg||Standard Deviation|Mean
791453|NCT00886600|Secondary|Mean Change From Baseline in Sitting Diastolic Blood Pressure (siDBP) After Adding HCTZ 24 Hours After Morning Dose at Week 6||Baseline and 24-hours after morning dose at Week 6|"The efficacy analysis followed a per protocol approach in that only patients who completed the study according to the protocol were included in the analysis."||mm Hg||Standard Deviation|Mean
791454|NCT00886600|Secondary|Mean Change From Baseline in Sitting Diastolic Blood Pressure (siDBP) 24 Hours After Morning Dose at Week 4||Baseline and 24-hours after morning dose at Week 4|"The efficacy analysis followed a per protocol approach in that only patients who completed the study according to the protocol were included in the analysis."||mm Hg||Standard Deviation|Mean
791455|NCT00886600|Primary|Mean Change From Baseline in 24-hour Systolic Ambulatory Blood Pressure Monitoring (ABPM) at Week 4||24-hour period at baseline and Week 4|"The efficacy analysis followed a per protocol approach in that only patients who completed the study according to the protocol were included in the analysis."||mm Hg||Standard Deviation|Mean
791456|NCT00886600|Primary|Mean Change From Baseline in 24-hour Diastolic Ambulatory Blood Pressure Monitoring (ABPM) at Week 4||24 hour period at Baseline and Week 4|"The efficacy analysis followed a per protocol approach in that only patients who completed the study according to the protocol were included in the analysis."||mm Hg||Standard Deviation|Mean
791457|NCT00886613|Secondary|Number of Healthy Elderly Men and Women With Injection Site Adverse Events Post Administration of VZV Skin Tests (Part B)|The number of participants with injection site adverse events due to the VZV skin test after administration of the VZV skin test antigen.|1-5 days post administration of each VZV skin test|Participants from Part B. One participant in the placebo group was not vaccinated and is not included in the analysis.||Participants|||Number
791458|NCT00886613|Primary|Number of Healthy, Elderly, Immunocompetent Participants With a Positive VZV Skin Test After Administration of 2 Doses of V212 Vaccine (Part B)|"Number of participants with a positive VZV skin test after 2 vaccine doses was determined. Participants with a negative VZV skin test reaction at baseline were evaluated for VZV immunogenicity by a final VZV skin test administered 14 days after dose 2 of vaccination.
For the VZV skin test participants were injected intradermally with the VZV skin test reagent, and reaction to the skin test was assessed after 48-72 hrs. A skin reaction (erythema and induration) around the injection site measuring >= 5mm for the VZV antigen was considered a positive skin test."|48-72 hours after administration of skin test at 14-17 days postdose 2|Per protocol population - participants with a negative baseline VZV Skin Test (<5 mm skin reaction to both, saline and the VZV skin test reagent), and who did not have a protocol deviation that could interfere with the immune response to vaccine following two administrations of either ZOSTAVAX™, placebo, or V212||Participants|||Number
791459|NCT00886613|Secondary|Number of Healthy Elderly Men and Women With Adverse Events Post Vaccination With V212 (Part B)|The number of participants with all serious and nonserious adverse events, and vaccine-related serious and nonserious adverse events, from 1-28 days post any vaccination dose was determined to assess safety. Non serious adverse events include injection-site adverse events as well as systemic adverse events post vaccination. Vaccine-related events include all events that were possibly, probably or definitely related to the vaccine according to the investigator. Participants with injection site adverse events due to administration of VZV skin tests are not included.|1-28 days post vaccination dose 1 and 1-28 days post vaccination dose 2|Participants from Part B. One participant in the placebo group was not vaccinated and is not included in the analysis.||Participants|||Number
791460|NCT00886613|Secondary|VZV Skin Test Reactions at 48 and 72 Hours (Part A)|Prior to vaccination, participants were administered a baseline VZV skin test for which the skin test reagent and saline were injected in opposite arms. The skin reaction (erythema and induration) around the injection site was assessed at 48 hours and at 72 hours. The reaction was marked with a ball point pen and the longest dimension closest to 1 mm was measured. Participants with a reaction measure < 5mm for saline and < 5mm for the VZV antigen were defined as having a negative baseline skin test; and a measure of >= 5mm for the VZV antigen were defined as having a positive skin test.|48 hours and 72 hours post administration of baseline skin test|42 participants enrolled in Part A||Participants|||Number
791461|NCT00886613|Primary|Number of Participants With a Negative VZV Skin Test at Baseline (Part A)|Participants were given the VZV skin test prior to vaccination. For the baseline VZV skin test, they were administered VZV skin test reagent and saline in opposite arms, and assessed for a skin reaction around the injection site. The skin reaction assessed was erythema (redness of skin) and induration (palpable, raised, hardened area) around the injection site, which was marked with a ball point pen. The longest dimension to the closest 1 mm was measured. Participants with a reaction measure < 5mm for saline and < 5mm for the VZV antigen were considered to have a negative baseline skin test.|48 hours following administration of the baseline skin test|Participants enrolled in Part A with a negative reaction for saline.||Participants|||Number
791462|NCT00886613|Other Pre-specified|Number of Participants With a Negative Reaction for Saline at Baseline (Part A)|Participants were given the VZV skin test prior to vaccination. For the baseline VZV skin test, they were administered VZV skin test reagent and saline in opposite arms. The skin reaction (erythema and induration) to saline was marked with a ball point pen. The longest dimension to the closest 1 mm was measured. Participants with a reaction measure < 5mm for saline had a negative reaction for saline, and measure >= 5mm for saline had a positive reaction for saline at baseline.|48 hours following administration of the baseline skin test|42 participants enrolled in Part A||Participants|||Number
791463|NCT00886626|Primary|Change in Body Mass Index (BMI)|Change in body mass index (BMI) over three months|3-month|Data from all participants who completed the trial were analyzed.||change in kg/m^2||Standard Deviation|Mean
791464|NCT00886639|Secondary|Oxygen Saturation|Change of oxygen saturation from minute 0 to 6 in 6Minute-walking test on oxygen/ medical air|day 22: minute 0 and 6||||||
791465|NCT00886639|Secondary|Oxygen Saturation|Change of oxygen saturation from minute 0 to 6 in 6Minute-walking test on oxygen/ medical air|day 21: minute 0 and 6||||||
791466|NCT00886639|Secondary|Oxygen Saturation|Change of oxygen saturation from minute 0 to 6 in 6Minute-walking test on oxygen/ medical air|day 2: minute 0 and 6||||||
791467|NCT00886639|Secondary|Oxygen Partial Pressure (paO2)|change in paO2 from minute 0 to minute 6 in 6-minute-walking test on oxygen/ medical air|"day 2: minute 0 and 6"||||||
791468|NCT00886639|Secondary|Oxygen Partial Pressure (paO2)|change in paO2 from minute 0 to minute 6 in 6-minute-walking test on oxygen/ medical air|day 20: minute 0 and minute 6||||||
791469|NCT00886639|Secondary|BORG-Score|change of BORG-Score from pre to post 6 minute-walking test (minute 0 and 6)on oxygen/ medical air|day 21: minute 0 and minute 6||||||
791470|NCT00886639|Secondary|BORG-Score|change of BORG-Score from pre to post 6 minute-walking test (minute 0 and 6)on oxygen/ medical air|day 22: minute 0 and minute 6||||||
791471|NCT00886639|Secondary|BORG-Score|change of BORG-Score from pre to post 6 minute-walking test (minute 0 and 6)on oxygen/ medical air|day 2: minute 0 and minute 6||||||
791472|NCT00886639|Secondary|Oxygen Partial Pressure (paO2)|change in paO2 from minute 0 to minute 6 in 6-minute-walking test on oxygen/ medical air|day 21: minute 0 and minute 6||||||
791473|NCT00886639|Secondary|Oxygen Saturation|Change of oxygen saturation from minute 0 to 6 in 6Minute-walking test on oxygen/ medical air|day 1: minute 0 and 6||||||
791474|NCT00886639|Secondary|BORG-Score|change of BORG-Score from pre to post 6 minute-walking test (minute 0 and 6)on oxygen/ medical air|day 1: minute 0 and minute 6||||||
791475|NCT00886639|Secondary|Lung Function|change in lung function from baseline to 3 weeks|day 1 and 21||||||
791476|NCT00886639|Secondary|Diffusion Capacity|change in diffusion capacity from baseline to 3 weeks|day 1 and 21||||||
791477|NCT00886639|Secondary|Oxygen Partial Pressure (paO2)|change in paO2 from minute 0 to minute 6 in 6-minute-walking test on oxygen/ medical air|"day 1: minute 0 and 6"||||||
791478|NCT00886639|Primary|Oxygen Response|Change in oxygen response (6-minute-walking distance on oxygen minus 6-minute-walking distance on medical air) from baseline to 3 weeks|day 1 and day 2; day 21 and day 22|per protocol||Meter||Standard Deviation|Mean
791479|NCT00886704|Primary|Omega-3 Index|Percentage of eicosapentaenoic and docosahexaenoic acids in total red cell fatty acids, as determined with a standardized analytical procedure, i.e. the HS-Omega-3 Index. Currently, the target range for the HS-Omega-3 Index has been suggested to be between 8% and 11%. Cardiovascular risk increases at levels below 8%, whereas levels above 11% do not seem to confer further benefit. Values of the HS-Omega-3 Index have been found between 1.5% and 20%.|after eight weeks of intervention|||% EPA+DHA in total red cell fatty acids||Standard Deviation|Median
791480|NCT00886704|Secondary|Palatability|Palatability assessed as number on a visual analogue scale from 0 - 10, with 0 being the worst and 10 being the best possible outcome|at 8 weeks|Per protocol analysis||Number on a scale from 0 - 10||Standard Deviation|Mean
791481|NCT00886743|Other Pre-specified|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Oprelvekin|Tmax was obtained directly from the serum oprelvekin concentration data using noncompartmental methods.|Postdose Day 1 to end of treatment|All participants who received at least 1 dose of study drug and had at least 1 concentration assessment.||hours|||Number
791482|NCT00886743|Other Pre-specified|Maximum Observed Plasma Concentration (Cmax) of Oprelvekin|Cmax was obtained directly from the serum oprelvekin concentration data using noncompartmental methods.|Postdose Day 1 to end of treatment|All participants who received at least 1 dose of study drug and had at least 1 concentration assessment.||picograms/mililiter|||Number
791483|NCT00886743|Secondary|Number of Participants With Corrected QT (QTc) Interval ≥450, ≥480, and ≥500 Msec Using Bazett's (QTcB) and Fridericia's (QTcF) Correction Formulas|Definition of QTc is based on observed individual values rather than the average across triplicate starting from Day 1 postdose through the end of treatment.|Postdose Day 1 to end of treatment|Participants who completed baseline and postdose triplicate electrocardiograms through at least 3 continuous days of dosing. Those who received any systemic concomitant medications that had the potential for drug interaction and sporadic effect on QT/QTc data, and thus impacted results, were excluded from the analyses.||Participants|||Number
791484|NCT00886743|Secondary|Number of Participants With Time-matched Change From Baseline in Corrected QT (QTc) Interval ≥30 or 60 Msec Using Fridericia's (QTcF) and Bazett's (QTcB) Correction Formulas|Based on average across triplicates for a given hourly measurement.|Postdose Day 1 to end of treatment|Participants who completed baseline and postdose triplicate electrocardiograms through at least 3 continuous days of dosing. Those who received any systemic concomitant medications that had the potential for drug interaction and sporadic effect on QT/QTc data, and thus impacted results, were excluded from the analyses.||Participants|||Number
791485|NCT00886743|Primary|Time-matched Change From Baseline in Corrected QT Interval Using a Population-specific Correction Formula (QTcN)|Because the sponsor terminated the study prematurely, this population-specific correction of QT was not done. QT data collected during the study corrected using the Bazett’s and Fridericia formulae are presented as secondary outcome measures.|Postdose Day 1 to end of treatment||||||
791486|NCT00886769|Secondary|Change in Disability Score Over Time by Use of the CHAQ|The disability dimension of CHAQ consisted of 20 multiple choice items about difficulty in doing eight common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Four response categories range from ‘without any difficulty’(0) to ‘unable to do’ (3). Mixed linear model on change from baseline in CHAQ score included treatment group, stratification factors, day of assessment and interaction between group and day as covariates. Negative change indicates improvement.|At 4 week study period|The Full Analysis Set (FAS) consisted of all randomized patients who received at least one dose of study drug. Only observed cases were used in the analysis.||Units on a Scale||Standard Error|Least Squares Mean
791487|NCT00886769|Secondary|Change in Health-related Quality of Life (HRQoL)Over Time by Use of the Child Health Questionnaire – Parent Form (CHQ-PF50)|CHQ-PF50 measures HRQoL in children 5-18 years old from parent’s perspective. Questionnaire completed by parent without input from patient. Total score ranges from 0-100. Increases in scores represent improved well-being in subjects as assessed by their parents. Mixed linear model on change from baseline in CHQ-PF50 score with treatment group, stratification factors, day of assessment and interaction between group and day as covariates. Covariance analysis used a repeated measures approach, so all timepoints over time were taken into account.|Over 4 week study period (Baseline, Day 15, Day 29)|The Full Analysis Set (FAS) consisted of all randomized patients who received at least one dose of study drug. Observed cases only were analyzed.||units on a scale||Standard Error|Least Squares Mean
791488|NCT00886769|Secondary|Percentage of Patients Who Had Body Temperature ≤ 38°C|Body temperature was derived from vital signs evaluation. No conversion of body temperature was performed, no matter how it was measured.|Day 3|The Full Analysis Set (FAS) consisted of all randomized patients who received at least one dose of study drug. Only observed cases were used in the analysis.||Percent of participants|||Number
791489|NCT00886769|Secondary|Change in Patient's Pain Intensity as Assessed on a 100-mm Visual Analog Scale (VAS) as Part of CHAQ|CHAQ, assessed physical ability and functional status of patients as well as quality of life. The disability dimension consisted of 20 multiple choice items about difficulty in doing eight common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Four response categories range from ‘without any difficulty’(0) to ‘unable to do’ (3). The parent’s or patient’s pain assessment was on VAS that was part of CHAQ. The VAS scale ranges from no pain (0 mm) to very severe pain (100 mm). Negative change indicates improvement.|Baseline, Day 29|The Full Analysis Set (FAS) consisted of all randomized patients who received at least one dose of study drug. Only observed cases were used in the analysis.||Units on a scale||Standard Error|Least Squares Mean
791490|NCT00886769|Secondary|Change in Patient's Pain Intensity as Assessed on a 100-mm Visual Analog Scale (VAS)as Part of the Childhood Health Assessment Questionnaire(CHAQ)|CHAQ assessed physical ability and functional status of patients as well as quality of life. The disability dimension consisted of 20 multiple choice items about difficulty in doing eight common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Four response categories range from ‘without any difficulty’ (0) to ‘unable to do’ (3). The parent’s or patient’s pain assessment was on VAS that was part of CHAQ. The VAS scale ranges from no pain (0 mm) to very severe pain (100 mm). Negative change indicates improvement.|Baseline, Day 15|The Full Analysis Set (FAS) consisted of all randomized patients who received at least one dose of study drug. Only observed cases were used in the analysis.||Units on a scale||Standard Error|Least Squares Mean
791491|NCT00886769|Secondary|Percentage of Patients Achieving the Adapted ACR Pediatric 100|Adapted ACR Pediatric 100 criteria determined responders (ie improved from baseline of at least 100% in at least 3 response variables 1-6 and no intermittent fever in preceding week [variable 7], with no more than one variable 1-6 worsening > 30% ) 1. Physician's Global Assessment of disease activity: 0-100 mm VAS 2. Parent/Patient's Global Assessment of Patient's overall wellbeing: 0-100mmVAS in Child Health Assessment Questionnaire (CHAQ) 3. Functional ability: CHAQ 4. Number of joints with active arthritis 5. Number of joints with limited of motion 6. Laboratory measure of inflammation|baseline, Day 15, Day 29|The Full Analysis Set (FAS) consisted of all randomized patients who received at least one dose of study drug.||percent of participants|||Number
791704|NCT00879879|Primary|Stable or Improved Forced Vital Capacity (FVC) Response at 1 Year|"Forced vital capacity (FVC) must be >= 50% at baseline. Stable FVC response is defined as a -5% change in FVC from baseline up to a +5% change from baseline.
Improved FVC response is defined as 5% or greater increase in the predicted value of FVC on pulmonary function testing following 12 months of treatment."|1 year|||participants|||Number
791492|NCT00886769|Secondary|Percentage of Patients Achieving the Adapted ACR Pediatric 90|Adapted ACR Pediatric 90 criteria determined responders (improved from baseline of at least 90% in at least 3 response variables 1-6 and no intermittent fever in preceding week [variable 7], with no more than one variable 1-6 worsening > 30% ) 1. Physician's Global Assessment of disease activity: 0-100 mm VAS 2. Parent/Patient's Global Assessment of Patient's overall wellbeing: 0-100mmVAS in Child Health Assessment Questionnaire (CHAQ) 3. Functional ability: CHAQ 4. Number of joints with active arthritis 5. Number of joints with limited of motion 6. Laboratory measure of inflammation CRP(mg/L)|Baseline, Day 15, Day 29|The Full Analysis Set (FAS) consisted of all randomized patients who received at least one dose of study drug.||percent of participants|||Number
791493|NCT00886769|Secondary|Percentage of Patients Achieving the Adapted ACR Pediatric 70|Adapted ACR Pediatric 70 criteria determined responders (improved from baseline of at least 70% in at least 3 response variables 1-6 and no intermittent fever in preceding week [variable 7], with no more than one variable 1-6 worsening > 30% ) 1. Physician's Global Assessment of disease activity: 0-100 mm VAS 2. Parent/Patient's Global Assessment of Patient's overall wellbeing: 0-100mmVAS in Child Health Assessment Questionnaire (CHAQ) 3. Functional ability: CHAQ 4. Number of joints with active arthritis 5. Number of joints with limited of motion 6. Laboratory measure of inflammation CRP(mg/L)|Baseline, Day 15, Day 29|The Full Analysis Set (FAS) consisted of all randomized patients who received at least one dose of study drug.||percent of participants|||Number
791494|NCT00886769|Secondary|Percentage of Patients Achieving the Adapted ACR Pediatric 50 Criteria|Adapted ACR Pediatric 50 criteria determined responders (improved from baseline of at least 50% in at least 3 response variables 1-6 and no intermittent fever in preceding week [variable 7], with no more than one variable 1-6 worsening > 30%) 1. Physician's Global Assessment of disease activity: 0-100 mm VAS 2. Parent/Patient's Global Assessment of Patient's overall wellbeing: 0-100mmVAS in Child Health Assessment Questionnaire (CHAQ) 3. Functional ability: CHAQ 4. Number of joints with active arthritis 5. Number of joints with limited of motion 6. Laboratory measure of inflammation CRP (mg/L)|Baseline, Day 15, Day 29|The Full Analysis Set (FAS) consisted of all randomized patients who received at least one dose of study drug.||percentage of participants|||Number
791495|NCT00886769|Primary|Percentage of Patients Who Meet the Adapted American College of Rheumatology (ACR) Pediatric 30 Criteria|Adapted ACR Pediatric 30 criteria determined responders (improved from baseline of at least 30% in at least 3 response variables 1-6 and no intermittent fever in preceding week [variable 7], with no more than one variable 1-6 worsening > 30% ) 1. Physician's Global Assessment of disease activity: 0-100 mm VAS 2.Parent/Patient's Global Assessment of Patient's overall wellbeing: 0-100mmVAS in Child Health Assessment Questionnaire (CHAQ) 3. Functional ability: CHAQ 4.Number of joints with active arthritis 5. Number of joints with limited of motion 6. Laboratory measure of inflammation CRP (mg/L)|Baseline, Day 15, Day 29|The Full Analysis Set (FAS) consisted of all randomized patients who received at least one dose of study drug.||percentage of participants|||Number
791496|NCT00886795|Secondary|Number of Participants With Clinically Detectable Improvement|Evaluations will occur at each visit after the first infusion. At 3 months, response will be recorded and patients with improvement will be eligible to move into the steroid and/or antihistamine tapering portion of the study. Improvement was determined by a reduction in the number of hives.|at each visit and at 3 months|||participants|||Number
791497|NCT00886795|Primary|Number of Participants With Adverse Events|Participants were monitored for adverse events (AEs) at each visit. Cumulative AEs were tracked including specific AE, severity, and relationship on source documentation. Special attention was given to infusion-related events and hypersensitivity reactions. Assessment of Complete Blood Count (CBC) and Metabolic profile were also tracked.|baseline, 3 month and 6 months|Participants who received all four doses.||participants|||Number
791498|NCT00886821|Other Pre-specified|Stage 2: Number of Participants With Anti-Drug Antibodies||Day 0, 29 and 50|Safety population included all randomized participants who received at least 1 dose of study medication. Here, number analyzed signifies those participants who were evaluable at specified time points.||Participants|||Count of Participants
791499|NCT00886821|Other Pre-specified|Stage 1: Number of Participants With Anti-Drug Antibodies||Day 0, 8, 14, 15, 21, 28 and 35|Safety population included all randomized participants who received at least 1 dose of study medication. Here, number analyzed signifies those participants who were evaluable at specified time points.||Participants|||Count of Participants
791500|NCT00886821|Other Pre-specified|Stage 1: Number of Participants With Clinically Significant Abnormal Rhythms|Criteria for abnormal rhythms: asymptomatic marked sinus bradycardia rate <35 bpm; asymptomatic supraventricular couplets, atrial bigeminy lasting >30 seconds; asymptomatic ventricular couplets, ventricular bigeminy lasting >30 seconds; asymptomatic type I second degree (wenckebach) atrioventricular block of >30 seconds duration; asymptomatic frequent premature ventricular complexes (=>200/24 hours); asymptomatic frequent premature atrial complexes (=>240/24 hours).|Cohort 1- 8: Day 1 up to Day 3; Cohort 9: Day 1 up to Day 10|Safety population will consist of all randomized patients who received at least 1 dose of study medication.||Participants|||Count of Participants
791501|NCT00886821|Other Pre-specified|Stage 1: Number of Participants With Hypoglycemia|Blood glucose level was checked for hypoglycemia by glucometer. Criteria for hypoglycemia: blood glucose level <60 mg/dL if accompanied by symptoms, blood glucose level <=50 mg/dL regardless of symptoms.|Day 1: 0 hour (pre-dose) up to 48 hours post dose|Safety population included all randomized participants who received at least 1 dose of study medication.||Participants|||Count of Participants
791502|NCT00886821|Other Pre-specified|Number of Participants With Clinically Significant Physical Examinations|Full physical examination included examination of the skin, eyes, ears, throat, neck, and cardiac, respiratory, gastrointestinal and musculoskeletal systems. The examination assessed the participants for any clinically significant changes in physical status, as determined by the investigator.|Cohort 1-8: Baseline up to Day 28; Cohort 9: Baseline up to Day 35; Cohort 10-12; Baseline up to Day 50|Safety population included all randomized participants who received at least 1 dose of study medication.||Participants|||Count of Participants
791513|NCT00886821|Secondary|Stage 1: Apparent Terminal Half-Life (t1/2) of PF-04856883 on Day 8|Apparent terminal elimination half-life is the time measured for the plasma concentration of PF-04856883 to decrease by one-half of its initial concentration.|pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 8|PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. The outcome was not planned to be analyzed for single dosing cohorts (Cohort 1 to 8), since the dosing was done only on Day 1 in these cohorts.||hour||Standard Deviation|Mean
791503|NCT00886821|Other Pre-specified|Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings|Criteria for ECG findings: PR interval >=300 millisecond (msec), >=25 percent increase when baseline >200 msec, and >=50 percent increase when baseline less than or equal to (<=) 200 msec; QRS interval >=200 msec, >=25 percent increase when baseline >=100 msec, and >=50 percent increase when baseline <=100 msec; QT/QTc interval (corrected QT interval) >=500 msec.|Cohort 1-8: Baseline up to Day 28; Cohort 9: Baseline up to Day 35; Cohort 10-12; Baseline up to Day 50|Safety population included all randomized participants who received at least 1 dose of study medication.||Participants|||Count of Participants
791504|NCT00886821|Other Pre-specified|Number of Participants With Clinically Significant Vital Signs|Criteria for vital signs: pulse rate <40 beats per minute (bpm), supine, sitting and erect pulse rate <40 bpm, supine pulse rate >120 bpm, sitting pulse rate >120 bpm, and erect pulse rate >120 bpm; systolic blood pressure: SBP <90 millimeters of mercury (mmHg), change from baseline in SBP greater than or equal to (>=) 30 mmHg; diastolic blood pressure: DBP <50 mmHg, change from baseline in DBP >=20 mmHg.|Cohort 1-8: Baseline up to Day 28; Cohort 9: Baseline up to Day 35; Cohort 10-12; Baseline up to Day 50|Safety population included all randomized participants who received at least 1 dose of study medication.||Participants|||Count of Participants
791505|NCT00886821|Other Pre-specified|Number of Participants With Clinically Significant Laboratory Abnormalities|Criteria for laboratory abnormalities: Hemoglobin (Hgb), hematocrit: less than (<) 0.8*lower limit of normal (LLN), platelet: <75 or greater than (>) 700*10^3/millimeter (mm)^3*upper limit of normal (ULN), leukocyte: <2.5 or >17.5*10^3/mm^3*ULN; total bilirubin 1.5*ULN, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma-glutamyl transferase: >3.0*ULN, total protein, albumin: <0.8*LLN or >1.2*ULN ;blood urea nitrogen, creatinine: >1.3*ULN, uric acid >1.2*ULN; sodium <0.95*LLN or >1.05*ULN, potassium, calcium: <0.9*LLN or >1.1*ULN, albumin, total protein <0.8*LLN or >1.2*ULN; glucose <0.6*LLN or >1.5*ULN, creatine kinase >2.0*ULN; urine (red blood cell, white blood cell >6/high power field).|Cohort 1-8: Baseline up to Day 28; Cohort 9: Baseline up to Day 35; Cohort 10-12; Baseline up to Day 50|Safety population included all randomized participants who received at least 1 dose of study medication.||Participants|||Count of Participants
791506|NCT00886821|Other Pre-specified|Stage 1: Change From Baseline in 7-point Weighted Mean Glucose at Day 3 and Day 7|It was assessed by 7-point glucose measurements via the glucose oxidase method.|Baseline, Day 3 and 7|Pharmacodynamic analysis population included all randomized participants who had received at least 1 dose of study medication and had PD data.||milligram per deciliter(mg/dL)||Standard Deviation|Mean
791507|NCT00886821|Other Pre-specified|Stage 1: Change From Baseline in Post-Prandial Area Under the Curve (AUC) of Glucose at Day 3 and 7|Area under the glucose concentration-time curve from 0 minute (approximately 20 minutes prior to the meal) to 180 minutes post initiation of meal.|Baseline, Day 3 and 7|Pharmacodynamic analysis population included all randomized participants who had received at least 1 dose of study medication and had PD data. Here, number analyzed signifies those participants who were evaluable at specified time points.||milligram*hour per deciliter (mg*hr)/dL||Standard Deviation|Mean
791508|NCT00886821|Other Pre-specified|Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Cohort 1-8: Baseline up to Day 29; Cohort 9: Baseline up to Day 36; Cohort 10-12: Baseline up to Day 50|Safety population included all randomized participants who received at least 1 dose of study medication.||Participants|||Count of Participants
791509|NCT00886821|Secondary|Stage 1: Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC[0 - Inf]) of PF-04856883 on Day 1|AUC(0 - inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It was calculated as AUC (0-t) plus (last measurable concentration divided by apparent terminal elimination rate constant).|pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose Day 1|PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. Here, 'N' signifies those participants who were evaluable for this outcome measure. This outcome measure was not planned to be analyzed in multiple dosing cohort (Cohort 9), as pre specified in protocol.||L/hr||Geometric Coefficient of Variation|Geometric Mean
791510|NCT00886821|Secondary|Stage 1: Apparent Oral Clearance (CL/F) of PF-04856883 on Day 1|Apparent oral clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. It was obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug apparent oral clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose Day 1|PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. Here, 'N' signifies those participants who were evaluable for this outcome measure. This outcome measure was not planned to be analyzed in multiple dosing cohort (Cohort 9), as pre specified in protocol.||Liter per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
791511|NCT00886821|Secondary|Stage 1: Mean Residence Time (MRT) of PF-04856883 on Day 1|MRT is defined as AUMC(0 - inf) divided by AUC(0 - inf), where AUMC(0 - inf) is the area under the first moment curve from time 0 extrapolated to infinite time, calculated using the linear/log trapezoidal method and AUC(0 - inf) is the area under the concentration-time curve extrapolated to infinity.|pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose Day 1|PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. Here, 'N' signifies those participants who were evaluable for this outcome measure. This outcome measure was not planned to be analyzed in multiple dosing cohort (Cohort 9), as pre specified in protocol.||hour||Full Range|Median
791512|NCT00886821|Secondary|Stage 2: Apparent Terminal Elimination Half-Life (t1/2) of PF-04856883 on Day 22|Apparent terminal elimination half-life is the time measured for the plasma concentration of PF-04856883 to decrease by one-half of its initial concentration.|pre-dose, 1 and 6 hours post-dose on Day 22|PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. Here, 'N' signifies those participants who were evaluable for this outcome measure.||hour||Standard Deviation|Mean
791514|NCT00886821|Secondary|Stage 1: Apparent Terminal Elimination Half-Life (t1/2) of PF-04856883 on Day 1|Apparent terminal elimination half-life is the time measured for the plasma concentration of PF-04856883 to decrease by one-half of its initial concentration.|pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 1|PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. Here, 'N' signifies those participants who were evaluable for this outcome measure. This outcome measure was not planned to be analyzed in multiple dosing cohort (Cohort 9), as pre specified in protocol.||hour||Standard Deviation|Mean
791515|NCT00886821|Primary|Stage 2: Maximum Observed Plasma Concentration (Cmax) of PF-04856883 on Day 22||pre-dose, 1 and 6 hours post-dose on Day 22|PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. Here, 'N' signifies those participants who were evaluable for this outcome measure.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
791516|NCT00886821|Primary|Stage 1: Maximum Observed Plasma Concentration (Cmax) of PF-04856883 on Day 8||pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 8|PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. The outcome was not planned to be analyzed for single dosing cohorts (Cohort 1 to 8), since the dosing was done only on Day 1 in these cohorts.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
791517|NCT00886821|Primary|Maximum Observed Plasma Concentration (Cmax) of PF-04856883 on Day 1||Cohort 1-9: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 1; Cohort 10-12: pre-dose, 1 and 6 hours post-dose on Day 1|PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. Here, 'N' signifies those participants who were evaluable for this outcome measure.||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
791518|NCT00886821|Primary|Stage 2: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883 on Day 22||pre-dose, 1 and 6 hours post-dose on Day 22|PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. Here, 'N' signifies those participants who were evaluable for this outcome measure.||hour||Full Range|Median
791519|NCT00886821|Primary|Stage 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883 on Day 8||pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 8|PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. The outcome was not planned to be analyzed for single dosing cohorts (Cohort 1 to 8), since the dosing was done only on Day 1 in these cohorts.||hour||Full Range|Median
791520|NCT00886821|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883 on Day 1||Cohort 1-9: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 1; Cohort 10-12: pre-dose, 1 and 6 hours post-dose on Day 1|PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. Here, 'N' signifies those participants who were evaluable for this outcome measure.||hour||Full Range|Median
791521|NCT00886821|Primary|Stage 1: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-04856883 on Day 1|AUClast was defined as area under the concentration-time curve from time zero to the time of last measured concentration and calculated by using linear up/log down trapezoidal method.|pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 1|Pharmacokinetic (PK) analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. 'N'(Overall number of participants)=participants who were evaluable for this outcome measure. This outcome measure was not planned to be analyzed in multiple dosing cohort(Cohort 9),as pre-specified in protocol.||nanogram*hour per milliliter (ng*hr)/mL||Geometric Coefficient of Variation|Geometric Mean
791522|NCT00886834|Secondary|Patient Perceived Pain on a 100-point Visual Analogue Scale (VAS)|VAS; anchors: 0 =none, 100 mm= worst imaginable|prior to insertion, immediately after insertion, and prior to clinic discharge|2 of the placebo patients received pre-medication for pain and were excluded and 1 of the placebo patients did not return for IUD insertion.||units on a scale||Standard Deviation|Mean
791523|NCT00886834|Primary|Provider Perceived Ease of Insertion on a 100-point Visual Analogue Scale (VAS)|VAS (anchors: 0 = extremely easy, 100 mm= impossible)|Immediately post IUD insertion|2 of the placebo patients received pre-medication for pain and were excluded and 1 of the placebo patients did not return for IUD insertion.||units on a scale||Standard Deviation|Mean
791524|NCT00886899|Secondary|Total Procedural Fluoroscopy Time|Minus any time to determine CTO was refractory to standard guidewire|Intraprocedural|Fluoroscopy time was not available for two participants||minutes||Standard Deviation|Mean
791525|NCT00886899|Secondary|Total Procedure Time|Minus any time to determine CTO was refractory to standard guidewire|Intraprocedural|Procedure time data for two participants was not available.||minutes||Standard Deviation|Mean
791526|NCT00886899|Primary|30-day Major Adverse Cardiac Event (MACE) Rate|Defined as cardiac death, Q-wave and non-Q-wave [total creatinine kinase (CK) >2x upper limit of normal with a positive myocardial band (MB) fraction] myocardial infarction (MI), target lesion revascularization (TLR), and emergency bypass surgery.|30 Days|"Includes 21 patients with early (<30 day) follow-up"||percentage of participants||90% Confidence Interval|Number
791527|NCT00886899|Primary|Technical Success|Defined as the ability of the BridgePoint Medical System to successfully facilitate placement of a guidewire beyond a chronic total occlusion (CTO) in the true vessel lumen in cases that were otherwise refractory to treatment with a currently marketed guidewire|Intraprocedural|Three participants had two CTOs, so there were a total of 150 CTOs in 147 participants.||percentage of CTOs|Participants|90% Confidence Interval|Number
791528|NCT00886938|Primary|Average Change (Baseline-End of Treatment) Tinnitus Handicap Inventory (THI)|Patient self-reported Tinnitus Handicap Inventory (THI) The mean change (95% CI) in THI scores (Baseline - End of Treatment). Measures tinnitus severity, or how much tinnitus interrupts their life. The THI scores range from 0-100. 0 being no interruption, 100 being severe interruption in their life from tinnitus.|0,4 weeks|Total number of participants completing the full four weeks of treatment, according to protocol.||units on a scale||95% Confidence Interval|Mean
791529|NCT00887159|Secondary|PFS|Progression-free survival (PFS) is defined as the time from randomization to death or disease progression, whichever occurred first. Patients who were alive at the time of analysis are censored at the date at which they are last known to be alive and progression-free. This analysis is to evaluate the association between PFS and circulating tumor cells (CTCs).|Assessed every 6 weeks while on treatment or observation; follow-up after discontinuation of treatment or observation: every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-3 years from study entry|Eligible and treated patients who had baseline CTC results available for analysis.||months||95% Confidence Interval|Median
791530|NCT00887159|Secondary|Overall Survival (OS)|Overall survival is defined as the time from randomization to death or date of last known alive.|Assessed every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-3 years from study entry|Eligible and treated patients.||months||95% Confidence Interval|Median
791531|NCT00887159|Secondary|Response Rate|Response rate is defined as number of patients with complete response (CR) or partial response (PR) divided by all eligible and treated patients. Responses are evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) guideline. CR is defined as disappearance of all target and non-target lesions. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameters), and persistence of one or more non-target lesion(s).|Assessed every 6 weeks while on treatment or observation; follow-up after discontinuation of treatment or observation: every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-3 years from study entry|Eligible and treated patients.||Proportion of patients||95% Confidence Interval|Number
791532|NCT00887159|Primary|Progression-free Survival (PFS)|Progression-free survival (PFS) is defined as the time from randomization to death or disease progression, whichever occurred first. Patients who were alive at the time of analysis are censored at the date at which they are last known to be alive and progression-free.|Assessed every 6 weeks while on treatment or observation; follow-up after discontinuation of treatment or observation: every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-3 years from study entry|Eligible and treated patients.||months||95% Confidence Interval|Median
791533|NCT00887198|Secondary|Elimination Half-Life (t1/2)|The elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).|Up to Cycle 5, Day 1|Data was not reported as non-compartmental analysis was not performed due to sparse sampling.|||||
791534|NCT00887198|Secondary|Area Under the Plasma Concentration-time Curve From Time 0 to Time the Last Quantifiable Concentration of Abiraterone (AUC[0-infinity])|The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.|Up to Cycle 5, Day 1|Data was not reported as non-compartmental analysis was not performed due to sparse sampling.|||||
791535|NCT00887198|Secondary|Maximum Plasma Concentrations of Abiraterone||Up to Cycle 5, Day 1|Data was not reported as non-compartmental analysis was not performed due to sparse sampling.|||||
791536|NCT00887198|Secondary|Mean Plasma Concentrations of Abiraterone||Up to Cycle 5, Day 1|Data was not reported as non-compartmental analysis was not performed due to sparse sampling.|||||
791537|NCT00887198|Secondary|Number of Participants With Treatment Emergent Adverse Events|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study drug and up to 30 days after last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state.|From first dose of study drug up to 30 days after the last dose of study drug|Safety analysis set included all participants in the randomized population who received any study drug.||Participants|||Number
791538|NCT00887198|Secondary|Time to Prostate-specific Antigen (PSA) Progression|The time interval from the date of randomization to the date of PSA progression as defined in the protocol-specific prostate cancer Working Group 2 (PCWG2) criteria. A participant was considered to have a PSA progression if the PSA level had a 25 percent (%) or greater increase from nadir and an absolute increase of 2 nanogram/milliliter ((ng/mL) or more, which is confirmed by a second value obtained in 3 or more weeks. Participants who had no PSA progression at the time of the analysis were censored at the last known date of no PSA progression. Participants with no on-study PSA assessment or no baseline PSA assessment were censored at the date of randomization.|From randomization (Day 1) up to date of PSA progerssion or cutoff date (Month 18)|ITT population included all the randomized participants who were classified according to their assigned treatment group, regardless of the actual treatment received.||Months||95% Confidence Interval|Median
791539|NCT00887198|Secondary|Time to Deterioration in Eastern Cooperative Oncology Group (ECOG) Performance Score by >=1 Point|The time interval from the date of randomization to the first date at which there was at least a 1 grade change (worsening) in the ECOG performance status grade. Participants who had no deterioration in ECOG performance status grade at the time of the analysis were censored at the last known date of no deterioration. ECOG is a 5-point scale, where 0=Fully active, 1=Ambulatory, carry out work of sedentary nature, 2=Ambulatory, capable of all self-care, 3=Capable of limited self-care, confined to bed or chair more than 50% of waking hours, 4=Completely disabled, no self-care, totally confined to bed or chair, 5=Dead. Participants with no assessment were censored at the date of randomization.|From randomization (Day 1) up to first radiographic progression or cutoff date (Month 18)|ITT population included all the randomized participants who were classified according to their assigned treatment group, regardless of the actual treatment received.||Months||95% Confidence Interval|Median
791614|NCT00878800|Primary|Objective Response (CR and PR)|Measured by response rate using the RECIST (Response Evaluation Criteria in Solid Tumors) response criteria (response rate: Complete Response (CR) and Partial Response (PR)) following up to 6 cycles of treatment.|Throughout study, after every 2 cycles|The full-analysis set (FAS) comprises all patients enrolled in the study and receiving at least one dose of study drug, and for whom at least one tumor assessment was performed post baseline.||percentage of participants|||Number
791540|NCT00887198|Secondary|Time to Initiation of Cytotoxic Chemotherapy|The time interval from the date of randomization to the date of initiation of cytotoxic chemotherapy for prostate cancer. Participants who had no cytotoxic chemotherapy administration at the time of analysis were censored at the last known date when no cytotoxic chemotherapy was administered. Participants with no assessment were censored at the date of randomization.|From randomization (Day 1) up to initiation of cytotoxic chemotherapy or cutoff date (Month 18)|ITT population included all the randomized participants who were classified according to their assigned treatment group, regardless of the actual treatment received.||Months||95% Confidence Interval|Median
791541|NCT00887198|Secondary|Time to Opiate Use for Prostate Cancer Pain|The time interval from the date of randomization to the date of opiate use for cancer pain. Participants who have no opiate use at the time of analysis were censored at the last known date of no opiate use for cancer pain. Participants with no assessment were censored at the date of randomization.|From randomization (Day 1) up to first opiate use or end of study (Month 60)|ITT population included all the randomized participants who were classified according to their assigned treatment group, regardless of the actual treatment received.||Months||95% Confidence Interval|Median
791542|NCT00887198|Primary|Radiographic Progression-free Survival (rPFS)|The rPFS was defined as the time from randomization to the occurrence of one of the following: 1) a participant was considered to have progressed by bone scan if - a) the first bone scan with greater than or equal to (>=) 2 new lesions compared to baseline was observed in less than (<) 12 weeks from randomization and was confirmed by a second bone scan taken >=6 weeks later showing >=2 additional new lesions (a total of >=4 new lesions compared to baseline), b) the first bone scan with >=2 new lesions compared to baseline was observed in >=12 weeks from randomization and the new lesions were verified on the next bone scan >=6 weeks later (a total of >=2 new lesions compared to baseline); 2) progression of soft tissue lesions measured by computerized tomography (CT) or magnetic resonance imaging (MRI); 3) death from any cause.|From randomization (Day 1) up to first radiographic progression or cutoff date (Month 18)|ITT population included all the randomized participants who were classified according to their assigned treatment group, regardless of the actual treatment received.||Months||95% Confidence Interval|Median
791543|NCT00887198|Primary|Overall Survival|Overall survival is defined as the time from randomization to date of death from any cause.|From randomization (Day 1) up to end of study (Month 60)|Intent-to-treat (ITT) population included all the randomized participants who were classified according to their assigned treatment group, regardless of the actual treatment received.||Months||95% Confidence Interval|Median
791544|NCT00887224|Secondary|Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Score in the Double-blind Phase|WPAI is a 6 question participant rated questionnaire to determine the degree to which depression affected work productivity while at work and affected activities outside of work. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher score indicated greater impairment and less productivity.|Double-blind phase Baseline (Study Day 140), Week 14 (Study Day 238), Week 26 (Study Day 322)|All Randomized population. Change from baseline (Bsl) mean=adjusted mean change calculated using MMRM.||scores on a scale||Standard Error|Mean
791545|NCT00887224|Secondary|Change From Baseline of Double-blind Phase in World Health Organization (Five-Item) Well-Being Index|WHO-5 evaluates positive psychological well-being during the past 2 weeks and consists of 5 questions (felt cheerful, in good spirits; felt calm, relaxed; felt active, vigorous; woke up fresh, rested; and daily life filled with things that are interesting) each rated on a 6-point Likert scale from 0 (not present) to 5 (constantly present). Total raw score ranged from 0 (worst possible quality of life) to 25 (best possible quality of life). Change from baseline mean=adjusted mean change calculated using MMRM.|Double-blind phase Baseline (Study Day 140), Week 14 (Study Day 238), Week 26 (Study Day 322)|All Randomized population. N=number of participants with analyzable data at observation.||scores on a scale||Standard Error|Mean
791546|NCT00887224|Secondary|Number of Participants With Remission Based on Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score at Double-blind Phase Week 26|HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Nine items are scored on a 3 point scale (0=none/absent to 2=most severe) and 8 items are scored on a 5 point scale (0=none/absent to 4=most severe) for a maximum total score of 50; higher score indicates more depression. Remission defined as HAM-D17 total score ≤7.|Double-blind phase Week 26 (Study Day 322)|All Randomized population. N=number of participants with analyzable data at observation based on Last Observation Carried Forward (LOCF).||participants|||Number
791547|NCT00887224|Secondary|Change From Baseline in Hamilton Psychiatric Scale for Depression-6 Item (HAM-D6) Score in the Double-blind Phase|HAM-D6 is a standardized, clinician-administered rating scale is a subset of the HAM-D17 that assesses 6 items associated with major depression. The scale uses HAM-D17 items 1, 2, 7, 8, 10 and 13. Item 13 is scored 0 to 2 (0=none/absent to 2=most severe) and all others are scored 0 to 4 (0=none/absent to 4=most severe). Total score ranges from 0 to 22; higher score indicates more depression. Change from baseline mean=adjusted mean change calculated using MMRM.|Double-blind phase Baseline (Study Day 140) up to Week 26 (Study Day 322)|All Randomized population. N=number of participants with analyzable data at observation.||scores on a scale||Standard Error|Mean
791548|NCT00887224|Secondary|Change From Baseline in Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score in the Double-blind Phase|HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Nine items are scored on a 3 point scale (0=none/absent to 2=most severe) and 8 items are scored on a 5 point scale (0=none/absent to 4=most severe) for a maximum total score of 50; higher score indicates more depression. Change from baseline mean=adjusted mean change calculated using MMRM.|Double-blind phase Baseline (Study Day 140) up to Week 26 (Study Day 322)|All Randomized population. N=number of participants with analyzable data at observation.||scores on a scale||Standard Error|Mean
791615|NCT00878800|Primary|Dose Limiting Toxicity (DLT)|Dose Limiting Toxicity (DLT) of PXD101 and doxorubicin combination treatment|Throughout study|||Dose limiting toxicity|||Number
791549|NCT00887224|Secondary|Change From Baseline in Clinical Global Impression-Severity of Illness [CGI-S] Score in the Double-blind Phase|CGI-S is a 7-point clinician rated scale to assess severity of participant's current illness state; range of 1 (normal - not ill at all) to 7 (among the most extremely ill). Higher score = more affected. Change from baseline mean=adjusted mean change calculated using mixed-effects model for repeated measures (MMRM).|Double-blind phase Baseline (Study Day 140) up to Week 26 (Study Day 322)|All Randomized population. N=number of participants with analyzable data at observation.||scores on a scale||Standard Error|Mean
791550|NCT00887224|Secondary|Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale|CGI-I is a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale.|Double-blind phase Baseline (Study Day 140) up to Week 26 (Study Day 322)|All Randomized population. N=number of participants with analyzable data at observation (Observed Cases).||participants|||Number
791551|NCT00887224|Primary|Time to Relapse Following Randomization to the Double-blind (DB) Phase: Estimated Probability (Percent) of Relapse at DB Day 185|Time to relapse analyzed using log-rank test; defined as Hamilton Psychiatric Scale for Depression-17 item score ≥16 at any time during DB phase, discontinuation for unsatisfactory response or efficacy (need for additional or alternate treatment for depression, investigator decision to remove participant for efficacy reasons, or failure to return if investigator determined related to efficacy), hospitalization for depression, suicide attempt, or suicide. Participants who relapsed after DB day 185 or completed DB therapy without relapse were considered as censored on DB day 185 (study day 325).|Double-blind phase Baseline (Study Day 140) up to DB Day 185 (Study Day 325)|All Randomized population: all participants randomly assigned to the Double-blind treatment phase of the study.||percent estimated probability|||Number
791552|NCT00887250|Secondary|Mean Change From Baseline in Peak Sitting Diastolic Blood Pressure (SiDBP) at Week 12|Mean change from baseline in peak (6 hours post dose) SiDBP at Week 12|At baseline and at 12 weeks (6 hours post dose)|"The primary analysis employed an all patients treated approach that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available."||mm Hg||Standard Deviation|Mean
791553|NCT00887250|Secondary|Mean Change From Baseline in Peak Sitting Diastolic Blood Pressure (SiDBP) at Week 6|Mean change from baseline in peak (6 hours post dose) SiDBP at Week 6|At baseline and at 6 weeks (24 hours post dose)|"The primary analysis employed an all patients treated approach that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available."||mm Hg||Standard Deviation|Mean
791554|NCT00887250|Secondary|Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 6|Mean change from baseline in trough (24 hours post dose) SiDBP at Week 6|At baseline and at 6 weeks (24 hours post dose)|"An all patients treated approach was employed that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available."||mm Hg||Standard Deviation|Mean
791555|NCT00887250|Secondary|Categories of Hypertensive Response in Trough Diastolic Blood Pressure (SiDBP) at Week 12|Patients with trough SiDBP <90 mm Hg were in Category I, ≥90 but decreased at least 10 mm Hg were in Category II, and ≥90 and decreased less than 10 mm Hg were in Category III.|24 hours post dose at Week 12|"An all patients treated approach was employed that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available."||Participants|||Number
791556|NCT00887250|Secondary|Categories of Hypertensive Response in Trough Diastolic Blood Pressure (SiDBP) at Week 6|Patients with trough SiDBP <90 mm Hg were in Category I, ≥90 but decreased at least 10 mm Hg were in Category II, and ≥90 and decreased less than 10 mm Hg were in Category III.|24 hours post dose at Week 6|"An all patients treated approach was employed that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available."||Participants|||Number
791557|NCT00887250|Primary|Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12|Mean change from baseline in trough (24 hours post dose) SiDBP at Week 12|At baseline and at 12 weeks (24 hours post dose)|"The primary analysis employed an all patients treated approach that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available."||mm Hg||Standard Deviation|Mean
791558|NCT00887289|Secondary|Behavioural Changes During Treatment|Number of patients with occurence of behavioural changes in terms of impulse control disorders|Baseline to Visit 3|Full analysis set, no imputation technique was applied||participants|||Number
791559|NCT00887289|Secondary|Summary of Change From Baseline in International Restless Legs Syndrome Scale for Severity to Visit 3|Change in IRLS at Visit 3 to baseline. The sum scores can have values in the range from 0 (best) to 40 (worst) A negative change is an improvement of IRLS, a positive change a worsening of IRLS.|Baseline to Visit 3|Full analysis set, no imputation technique was applied||Scores on scale||Standard Deviation|Mean
791560|NCT00887289|Secondary|Summary of Change From Baseline in Restless Legs Syndrome Severity Scale With 6 Questions to Visit 3|Change in RLS-6 at Visit 3 to baseline. The sum scores can have values in the range from 0 (best) to 20 (worst) A negative change is an improvement of RLS-6, a positive change a worsening of RLS-6.|Baseline to Visit 3|Full analysis set (FAS)||Scores on scale||Standard Deviation|Mean
791561|NCT00887289|Primary|Summary of Change From Baseline in Total Sum of McGill Pain Questionnaire to Visit 3 for Patients Treated by Neurologist|Change in Total Sum Score of McGill Pain Questionnaire at Visit 3 to baseline. The sum scores can have values in the range from 0 (no pain) to 20 (worst pain). A negative change is an improvement of pain, a positive change a worsening of pain.|Baseline to Visit 3|All patients of the full analysis set treated by a neurologist, no imputation technique was applied||Scores on scale||Standard Deviation|Mean
791562|NCT00887289|Primary|Summary of Change From Baseline in Total Sum of McGill Pain Questionnaire to Visit 3 for Patients Treated by General Practitioner|Change in Total Sum Score of McGill Pain Questionnaire at Visit 3 to baseline. The sum scores can have values in the range from 0 (no pain) to 20 (worst pain). A negative change is an improvement of pain, a positive change a worsening of pain.|Baseline to Visit 3|All patients of the full analysis set treated by a general practitioner, no imputation technique was applied||Scores on scale||Standard Deviation|Mean
791563|NCT00887289|Primary|Summary of Change From Baseline in Total Sum of McGill Pain Questionnaire to Visit 3|Change in Total Sum Score of McGill Pain Questionnaire at Visit 3 to baseline. The sum scores can have values in the range from 0 (no pain) to 20 (worst pain). A negative change is an improvement of pain, a positive change a worsening of pain.|Baseline to Visit 3|Full analysis set, no imputation technique was applied||Scores on scale||Standard Deviation|Mean
791564|NCT00887315|Secondary|Overall PFS and CT Rate|Overall PFS and CT rate is assessed response with PET and CT. Toxicity of addition of high dose focused RT to systemic therapy.Late (>90 day) radiotherapy toxicity will be assessed with RTOG/EORTC late RT toxicity guidelines|>90 days|The study was terminated before conclusions were reached so no data was analyzed.|||||
791565|NCT00887315|Primary|1-Year Overall Survival|Overall survival is assessed at 1 year from the date of study enrollment to date of death.|Baseline to death from any cause, 1 year|The study was terminated before conclusions were reached so no data was analyzed.|||||
791566|NCT00878501|Secondary|Mean of Week 2 and Week 4 Changes From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Total Score, 48 Hours Recall|The WOMAC VA3.1. is a self-administered questionnaire that assesses pain, stiffness and disability related to osteoarthritis. It consists of a pain subscale (5 questions), function subscale (17 questions). and a stiffness subscale (2 questions). The total score was derived by calculating the mean of the VAS scores from all 24 questions with score scale ranging from 0 to 100, 0 being no pain, stiffness and difficulty in performing daily activities and 100 being extreme pain, stiffness and difficulty in performing daily activities.|Baseline, Week 2 and Week 4.|Number of Participants Analyzed for the stated measure are defined according to the Modified Intention To Treat analysis set whereas numbers provided in the Participant Flow Module correspond to number of participants enrolled.||mm||95% Confidence Interval|Least Squares Mean
791567|NCT00878501|Secondary|Mean of Week 2 and Week 4 Changes From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Stiffness Subscale, 48 Hours Recall.|The WOMAC VA3.1. is a self-administered questionnaire that assesses pain, stiffness and disability related to osteoarthritis. The Stiffness subscale consists of 2 questions (Severity of stiffness after first awakening in the morning and severity of stiffnes after periods of inactivity later in the day). WOMAC stiffness was derived by calculating the mean of the VAS scores from the 2 questions with score scale ranging from 0 to 100, 0 being no stiffness and 100 extreme stiffness.|Baseline, Week 2 and Week 4.|Number of Participants Analyzed for the stated measure are defined according to the Modified Intention To Treat analysis set whereas numbers provided in the Participant Flow Module correspond to number of participants enrolled.||mm||95% Confidence Interval|Least Squares Mean
791568|NCT00878501|Secondary|Mean of Week 2 and Week 4 Changes From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Function Subscale, 48 Hours Recall.|The WOMAC VA 3.1. is a self-administered electronic questionnaire that assesses pain, stiffness and disability related to OA. The Function (daily activities) subscale consists of 17 questions. WOMAC function was derived by calculating the mean of the VAS scores from the 17 questions with scores ranging from 0 to 100, 0 = no difficulty in performing daily activities and 100 = extreme difficulty.|Baseline, Week 2 and Week 4.|Number of Participants Analyzed for the stated measure are defined according to the Modified Intention To Treat analysis set whereas numbers provided in the Participant Flow Module correspond to number of participants enrolled.||mm||95% Confidence Interval|Least Squares Mean
791569|NCT00878501|Primary|Mean of Week 2 and Week 4 Changes From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Subscale, 48 Hours Recall.|The WOMAC pain subscale is a self-administered electronic scale with 5 questions (Walking on flat surface, Going up or down stairs, At night while in bed, Sitting or lying, Standing upright). Responses were recorded on a 50-mm line with 100 units. 0 mm indicated no pain and 50 mm indicated extreme pain. The scores were then converted to a 100-mm scale. WOMAC pain was derived by calculating the mean of the VAS scores from the 5 questions with score scale ranging from 0 to 100, 0 being no pain and 100 extreme pain.|Baseline, week 2, week 4.|Number of Participants Analyzed for the stated measure are defined according to the Modified Intention To Treat analysis set whereas numbers provided in the Participant Flow Module correspond to number of participants enrolled.||mm||95% Confidence Interval|Least Squares Mean
791570|NCT00878553|Secondary|Half-Life (t1/2 Hour) Pharmacokinetic (PK) Profile Characterization|"A detailed characterization of the plasma Half-Life (t1/2 in hours) of SKP-1041 zaleplon the each of the 3 study doses within the Pharmacokinetic Population (patients who completed the PK substudy--night 3 of Visit 6)with subsequent descriptive statistics comparing key PK characteristics across the 3 doses.
Descriptive statistics and analysis of variance (ANOVA)for independent groups compared the three dosage groups using the untransformed values, as well as following rank transformation(nonparametric analysis)."|Blood samples drawn hourly from -1 to 10 hours post-dose (except hour 7)|Pharmacokinetic Population--Patients who completed night 3 of Visit 6 (the PK substudy). Note that these patients had participated in a crossover design across all doses for the sleep study but had PK assessments only for one dose (parallel group design).||hour|Participants|Standard Error|Mean
791571|NCT00878553|Secondary|AUC/Dose (ng*h/mL/mg) Pharmacokinetic (PK) Profile Characterization|"A detailed characterization of the AUC/Dose (ng*h/mL/mg) [Area under the concentration-time curve per Dose of SKP-1041 zaleplon] for each of the 3 study doses within the Pharmacokinetic Population (patients who completed the PK substudy--night 3 of Visit 6)with subsequent descriptive statistics comparing key PK characteristics across the 3 doses.
Descriptive statistics and analysis of variance (ANOVA) for independent groups compared the three dosage groups using the untransformed values, as well as following rank transformation(nonparametric analysis)."|Blood samples drawn hourly from -1 to 10 hours post-dose (except hour 7)|Pharmacokinetic Population--Patients who completed night 3 of Visit 6 (the PK substudy). Note that these patients had participated in a crossover design across all doses for the sleep study but had PK assessments only for one dose (parallel group design).||ng*h/mL/mg|Participants|Standard Error|Mean
791572|NCT00878553|Secondary|AUC Pharmacokinetic (PK) Profile Characterization|"A detailed characterization of the AUC (area under the concentration-time curve of SKP-1041 zaleplon) for each of the 3 study doses within the Pharmacokinetic Population (patients who completed the PK substudy--night 3 of Visit 6)with subsequent descriptive statistics comparing key PK characteristics across the 3 doses.
Descriptive statistics were calculated for AUC. Analysis of variance (ANOVA) for independent groups compared the three dosage groups using the untransformed values, as well as following rank transformation(nonparametric analysis)."|Blood samples drawn hourly from -1 to 10 hours post-dose (except hour 7)|Pharmacokinetic Population--Patients who completed night 3 of Visit 6 (the PK substudy). Note that these patients had participated in a crossover design across all doses for the sleep study but had PK assessments only for one dose (parallel group design).||ng x h/mL|Participants|Standard Error|Mean
791573|NCT00878553|Secondary|Tmax Pharmacokinetic (PK) Profile Characterization|"A detailed characterization of Tmax (hour) (timepoint post-dose of maximum plasma zaleplon concentration) PK profile of SKP-1041 zaleplon for each of the 3 study doses within the Pharmacokinetic Population (patients who completed the PK substudy--night 3 of Visit 6)with subsequent descriptive statistics comparing key PK characteristics across the 3 doses.
Descriptive statistics and analysis of variance (ANOVA) for independent groups compared the three dosage groups using the untransformed values, as well as following rank transformation(nonparametric analysis)."|Blood samples drawn hourly from -1 to 10 hours post-dose (except hour 7)|Pharmacokinetic Population--Patients who completed night 3 of Visit 6 (the PK substudy). Note that these patients had participated in a crossover design across all doses for the sleep study but had PK assessments only for one dose (parallel group design).||Hours post-dose|Participants|Standard Error|Mean
791574|NCT00878553|Secondary|Cmax/Dose(Dose-Normalized Cmax)Pharmacokinetic (PK) Profile Characterization|"A detailed characterization of Cmax/Dose (ng/mL/mg) (maximum plasma zaleplon concentration normalized per dose) PK profile of SKP-1041 zaleplon for each of the 3 study doses within the Pharmacokinetic Population (patients who completed the PK substudy--night 3 of Visit 6)with subsequent descriptive statistics comparing key PK characteristics across the 3 doses.
Descriptive statistics, geometric means and 90% confidence intervals were calculated for dose-normalized values of Cmax. Analysis of variance (ANOVA) for independent groups compared the three dosage groups using the untransformed values, as well as following rank transformation(nonparametric analysis)."|Blood samples drawn hourly from -1 to 10 hours post-dose (except hour 7)|Pharmacokinetic Population--Patients who completed night 3 of Visit 6 (the PK substudy). Note that these patients had participated in a crossover design across all doses for the sleep study but had PK assessments only for one dose (parallel group design).||ng/mL/mg zaleplon|Participants|Standard Error|Mean
791575|NCT00878553|Secondary|Cmax Pharmacokinetic (PK) Profile Characterization|"A detailed characterization of the Cmax (maximum plasma concentration of SKP-1041 zaleplon in ng/mL) for each of the 3 study doses within the Pharmacokinetic Population (patients who completed the PK substudy--night 3 of Visit 6)with subsequent descriptive statistics comparing key PK characteristics across the 3 doses.
Descriptive statistics and analysis of variance (ANOVA) for independent groups compared the three dosage groups using the untransformed values, as well as following rank transformation(nonparametric analysis)."|Blood samples drawn hourly from -1 to 10 hours post-dose (except hour 7)|Pharmacokinetic Population--Patients who completed night 3 of Visit 6 (the PK substudy). Note that these patients had participated in a crossover design across all doses for the sleep study but had PK assessments only for one dose (parallel group design).||ng/mL|Participants|Standard Error|Mean
791576|NCT00878553|Secondary|Visual Analog Scale (Sedation)|"Self-assessment of next morning sedation. Patients answered the question How alert do you feel? via a 100mm scale on which 0mm indicated very sleepy and 100mm indicated wide awake and alert.The VAS measures a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. Operationally, a VAS is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end (in this case, sleepiness and alertness). Patients were asked to mark the point on the line that they felt represented their current state. The VAS score was determined by measuring in millimeters from the left-hand end of the line to the point that the patient marked."|9 hours after tablet ingestion|Safety population (patients exposed to that given treatment)||mm change from baseline||Standard Error|Mean
791577|NCT00878553|Secondary|Digit Span Test|Assessment of next day residual cognitive effects via testing immediate recall of numbers. The patient was given a string of digits and asked to repeat them forward, and then a second string of digits to repeat backward. The score was the number of correct responses, where the digits were repeated correctly. One point was given for each correctly repeated string of digits. The maximum subscore in the Digits Forward was 16, and the maximum subscore in the Digits Backward was 14, for a total score of 30.|9 hours post-dose|Intention to Treat population (all randomized patients)||units on a scale change from baseline||Standard Error|Mean
791578|NCT00878553|Secondary|Digit Symbol Substitution Test|Assessment of next-day residual cognitive effects. The Digit Symbol Substitution Test (DSST) explores attention and psychomotor speed. Given a code table displaying the correspondence between pairs of digits (from 1 to 9) and symbols, the patient filled in blank squares with the symbol that was paired with the digit displayed above the square. The patient was required to fill in as many squares as possible in 180 seconds.|9 hours after tablet ingestion|Intention to Treat population (all randomized patients)||percentage change from mean baseline||Standard Error|Mean
791579|NCT00878553|Secondary|Subjective Wake Time After Sleep Onset (sWASO)|Subjective wake time after sleep onset sourced from the Morning Sleep Questionnaire self-assessment|9 hours after tablet ingestion|All Efficacy Analyses were performed on the Intention to Treat (ITT) population (all randomized patients).||minutes||Standard Error|Mean
791580|NCT00878553|Secondary|Number of Awakenings After Sleep Onset During Hours 3 to 7 Post-dose (NAASO 3-7)|Number of Awakenings After Sleep Onset during hours 3-7 post-dose (inclusive) as measured with PSG (polysomnography)|hours 3-7 (inclusive) post-dose|Intention to Treat dataset (all randomized patients)||Number of awakenings||Standard Error|Mean
791581|NCT00878553|Secondary|Total Sleep Time 3-7 Hours Post-dose|Total Sleep Time during hours 3-7 (inclusive) post-dose|hours 3-7 (inclusive) post-dose|Intention to Treat population (all randomized patients)||Minutes||Standard Error|Mean
791582|NCT00878553|Secondary|WASO 1-8|Wake Time After Sleep Onset, measured in minutes over the full 8 hour polysomnographic recording period, is summarized by treatment group for each night during the Screening and Treatment Periods.|Constantly throughout the 8 hour sleep period|Intention to Treat population||Minutes||Standard Error|Mean
791583|NCT00878553|Primary|Wake After Sleep Onset During Hours 3 to 7 Post-dose (WASO 3-7)|Wake time After Sleep Onset hours 3-7 Pairwise comparisons of treatment group vs. placebo mean change from baseline in minutes per polysomnographic recording. Each patient receives baseline placebo and then each treatment dose at bedtime for two nights of sleep laboratory PSG measurements. The WASO3-7 mean of each two night visit is then used to compare placebo vs. treatment change from baseline minutes awake during hours 3 through 7 post-dose.|Hours 3-7 (inclusive) after tablet ingestion|Efficacy analyses were performed on the Intention to Treat Population(all randomized patients).||minutes||Standard Error|Mean
791584|NCT00878605|Primary|Hemoglobin A1C|% change HgbA1c from baseline to 12 weeks.|Baseline and Week 12||||||
791585|NCT00878644|Secondary|Neuropsychological Scores (for Participants That Survive)|Functioning, as assessed by the Mullen Early Learning Composite (for children age < 5 years 9 months) or by the 2-subset version of the Wechsler Abbreviated Scale of Intelligence (WASI). As these two function measures are scaled in the same fashion, the two age groups are combined.|Measured at Month 12|Randomized children alive at one year with neuropsychological score available.||Participants|||Count of Participants
791586|NCT00878644|Secondary|Change in Neurobehavioral Function From Pre-cardiac Arrest to 12 Months Post-cardiac Arrest|Change in VABS-II score from baseline to one year, with death at 1 year treated as worst possible outcome, and lowest possible VABS-II score at one year (regardless of baseline VABS-II score) treated as the second worst possible outcome.|Survival was assessed at one-year anniversary of cardiac arrest; among survivors at this one-year anniversary, the VABS-II valid assessment window ranged from 30 days prior to until 183 days after the one-year anniversary date.|All randomized subjects with available data for this outcome (this implies a child must be either dead at 1 year, have the lowest possible value for the VABS-II score at 1 year, or if neither of these two criteria applies, must have both baseline VABS-II and 1-year VABS-II scores available to allow calculation of change in VABS-II score)||Participants|||Count of Participants
791587|NCT00878644|Secondary|Survival|Survival at one year after cardiac arrest|Measured at one-year anniversary of cardiac arrest.|All randomized patients with available vital status (alive or deceased) at one year after cardiac arrest.||Participants|||Count of Participants
791588|NCT00878644|Primary|Survival With Good Neurobehavioral Outcome|Survival at one-year anniversary of cardiac arrest, with a standardized VABS-II score of 70 or greater per evaluation performed at any time from 30 days prior to until 183 days after the one-year anniversary of cardiac arrest.|Survival was assessed at one-year anniversary of cardiac arrest; among survivors at this one-year anniversary, the VABS-II valid assessment window ranged from 30 days prior to until 183 days after the one-year anniversary date.|Subjects with baseline VABS-II >= 70, OR unavailable baseline VABS-II but Pediatric Overall Performance Category (POPC) score and Pediatric Cerebral Overall Performance Category (PCPC) both reflecting none or mild disability (1 or 2), are eligible for the primary analysis. Population is analysis-eligible patients with available primary outcome.||Participants|||Count of Participants
791600|NCT00878722|Secondary|Elimination t½||Cycle 1, Samples taken in Cycle 1 only, prior to initial dose on days 4 and 5 and at end of infusion, 5, 15, and 30 min, and 1, 2, 3, 4, and 6 hours post infusion|Results shown for dose level 1000 mg/m2/d||Hours||Standard Deviation|Mean
791601|NCT00878722|Secondary|Belinostat AUC (Area Under Curve)||Cycle 1, prior to initial dose on days 4 and 5 and at end of infusion, 5, 15, and 30 min, and 1, 2, 3, 4, and 6 hours post infusion|Results shown for dose level 1000 mg/m2/d||ng*hrs/mL||Standard Deviation|Mean
791602|NCT00878722|Secondary|Belinostat Cmax|Cmax: Arm A: at Cycle 1 Day 4, Cycle 1 Day 5 Arm B: Cycle 1 Day 1 and Cycle 1 Day 2|Samples taken in Cycle 1 only, prior to initial dose on days 4 and 5 and at end of infusion, 5, 15, and 30 min, and 1, 2, 3, 4, and 6 hours post infusion|Results shown for dose level 1000 mg/m2/d||ng/mL||Standard Deviation|Mean
791603|NCT00878722|Secondary|Remission Duration|Remission duration: time (weeks) from date of remission status to disease relapse.|Throughout study, after each cycle for the first two cycles, then after every second cycle|Remission duration was reported among participants who reported response||Weeks||95% Confidence Interval|Mean
791604|NCT00878722|Secondary|Event-Free Survival|Event-free survival: time (weeks) from entry into study until treatment failure, disease relapse or death from any cause.|Throughout study, after each cycle for the first two cycles, then after every second cycle|||Weeks||95% Confidence Interval|Median
791605|NCT00878722|Secondary|Relapse-Free Survival|Relapse-free survival: time (weeks) from leukemia-free state to relapse or death from any cause.|Throughout study, after each cycle for the first two cycles, then after every second cycle|Relapse free survival was reported among participants who reported response||Weeks|||Number
791606|NCT00878722|Secondary|Overall Survival|Overall survival: time in weeks from entry into study until death from any cause. All patients without this endpoint at the time of discontinuation or the end of trial have been censored.|Throughout study, after each cycle for the first two cycles, then after every second cycle|||Weeks||95% Confidence Interval|Median
791607|NCT00878722|Secondary|Duration of Response (CR and PR)|Duration of Response (CR and PR) in Weeks|Throughout study, after each cycle for the first two cycles, then after every second cycle|All patients who received at least one dose of belinostat and/or idarubicin were included in the full analysis set (FAS). Duration of response was reported among participants who reported response||weeks||Full Range|Mean
791608|NCT00878722|Secondary|Time to Response (CR and PR)|Time to response: time in weeks from first treatment to obtainment of the particular response status (CR and PR)|Throughout study, after each cycle for the first two cycles, then after every second cycle|Time to response was reported among participants who reported response||Weeks||95% Confidence Interval|Median
791609|NCT00878722|Primary|Overall Response|Efficacy measured as Response rate (complete response ([CR] and Complete remission with incomplete recovery of platelets [CRi]) and partial response ([PR])) using the response criteria of the International Working Group (Cheson et al 2003). CR includes CRi, CRc (Cytogenetic complete remission), and CRm (Molecular complete remission).|Throughout study, after each cycle for the first two cycles, then after every second cycle|||participants|||Number
791610|NCT00878722|Primary|Maximum Tolerated Dose, Dose Limiting Toxicity|DLT (dose limiting toxicities): patients with any of the toxicities: 1.Haematological toxicity is not included in the definition due to bone marrow involvement by the disease except for following grade 4 ANC (absolute neutrophil count) and PLT (platelet count) for 6 weeks with less than 5% blasts in bone marrow. 2.Drug related non hematological Grade 3 or 4 toxicity except alopecia, brief nausea and vomiting, diarrhea, rash, arthralgias and myalgias. Treatment interventions should palliate toxicity symptoms prior to concluding a DLT has occurred (e.g if nausea and vomiting to Grade 3 have been associated with the drug). If despite standard treatment Grade 3 nausea and or vomiting persisted then a DLT was considered to have occurred. Grade 4 diarrhea in spite of standard therapeutic measures was included in DLT definition. 3.Inability to tolerate full dosing cycle due to toxicity or any drug-related adverse event resulting in more than 14 day treatment delay in the next treatment cycle|First Cycle|||participants|||Number
791611|NCT00878800|Secondary|Belinostat t½|Measure the t½ of belinostat alone (Day 4 values) and in the presence of doxorubicin (Day 5 values) at the Maximum Tolerated Dose level: belinostat 1000 mg/m2 and doxorubicin 75 mg/m2|Cycle 1, Day 4 and Day 5, pre-infusion, at end of infusion and at 5 min, 15 min, 30 min, 1 h, 2 h, 2 h and 15 min, 2 h and 30 min, 3 h, 4 h, 6 h, 8 h and 24 h post infusion|The pharmacokinetic population consisted of all patients who were dosed and had evaluable pharmacokinetic data. Dose level belinostat 1000 mg/m² and belinostat 1000 mg/m² plus doxorubicin 75 mg/m² is presented.||hours||Geometric Coefficient of Variation|Geometric Mean
791612|NCT00878800|Secondary|Belinostat Cmax|Measure the Cmax of belinostat alone (Day 4 values) and in the presence of doxorubicin (Day 5 values) at the Maximum Tolerated Dose level: belinostat 1000 mg/m2 and doxorubicin 75 mg/m2|Cycle 1, Day 4 and Day 5, pre-infusion, at end of infusion and at 5 min, 15 min, 30 min, 1 h, 2 h, 2 h and 15 min, 2 h and 30 min, 3 h, 4 h, 6 h, 8 h and 24 h post infusion|The pharmacokinetic population consisted of all patients who were dosed and had evaluable pharmacokinetic data. Dose level belinostat 1000 mg/m² and belinostat 1000 mg/m² plus doxorubicin 75 mg/m² is presented.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
791613|NCT00878800|Secondary|Belinostat AUC (Time 0 to Last Measurement)|Measure the AUC of belinostat alone (Day 4 values) and in the presence of doxorubicin (Day 5 values) at the Maximum Tolerated Dose level: belinostat 1000 mg/m2 and doxorubicin 75 mg/m2|Cycle 1, Day 4 and Day 5, pre-infusion, at end of infusion and at 5 min, 15 min, 30 min, 1 h, 2 h, 2 h and 15 min, 2 h and 30 min, 3 h, 4 h, 6 h, 8 h and 24 h post infusion|The pharmacokinetic population consisted of all patients who were dosed and had evaluable pharmacokinetic data. Dose level belinostat 1000 mg/m² and belinostat 1000 mg/m² plus doxorubicin 75 mg/m² is presented.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
791676|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Urine Glucose).||Baseline up to Month 7|||percentage of participants|||Number
791616|NCT00878800|Secondary|Disease Control Rate (CR or PR or SD)|The disease control rate, defined as best overall response of either objective response or stable disease (CR or PR or SD) following up to 6 cycles of treatment with confirmation according to the RECIST criteria|Throughout study, after every 2 cycles|The full-analysis set (FAS) comprises all patients enrolled in the study and receiving at least one dose of study drug, and for whom at least one tumor assessment was performed post baseline.||percentage of participants|||Number
791617|NCT00878800|Secondary|Time to Progression||Throughout study, after every 2 cycles|Includes only patients with disease progression.||months||95% Confidence Interval|Median
791618|NCT00878800|Secondary|Duration of Response||Throughout study, after every 2 cycles|Includes only patients with response||Months||95% Confidence Interval|Median
791619|NCT00878800|Secondary|Time to Response||Throughout study, after every 2 cycles|Includes all 41 patients in the FAS population. 37 patients were censored due to no response, 23 in the Dose Escalation group and 14 in the MTD Expansion group.||months||Full Range|Median
791620|NCT00878800|Primary|Maximum Tolerated Dose (MTD) of Doxorubicin|Maximum Tolerated Dose (MTD) of doxorubicin|During Cohort 1 to 4, Cycle 1 only, up to 3 weeks|||mg/m2|||Number
791621|NCT00878800|Primary|Maximum Tolerated Dose (MTD) PXD101|Maximum Tolerated Dose (MTD) of PXD101treatment|During Cohort 1 to 4, Cycle 1 only, up to 3 weeks|||mg/m²|||Number
791622|NCT00878826|Secondary|Side Effect - Bruising||Enrollment through 6 weeks postpartum|||participants|||Number
791623|NCT00878826|Secondary|Bleeding Events||Enrollment through 6 weeks postpartum|||participants|||Number
791624|NCT00878826|Secondary|Thromboembolic Events||Enrollment through 6 weeks postpartum|||participants|||Number
791625|NCT00878826|Primary|Peak Anti-Xa Level|Goal peak anti-Xa level is 0.2 to 0.4 u/ml. We compared peak drug levels between different dosing arms.|One measurement per trimester of pregnancy, up to 36 weeks|||u/ml||Standard Deviation|Mean
791626|NCT00878878|Primary|Observed the Change of Pulmonary Vascular Resistance (PVR) Measured by Wood Units Within Certain Time Periods. This is Per Sequence and Not a Cross-over Study.|Measurement of the pulmonary vascular resistance (PVR) results, which was taken from the subject in Wood Units, taken at Baseline and at 2 minutes, 6 minutes and 10 minutes. This is per sequence and not a cross-over study.|Measurements recorded at Baseline, 2 minutes, 6 minutes and 10 minutes post contrast administration|The pulmonary vascular resistance (PVR) results were taken at Baseline and at 2 minutes, 6 minutes and 10 minutes.||Wood Units||Standard Deviation|Mean
791627|NCT00878878|Secondary|Recorded Any Adverse Events From the Optison and Control Solution (5% Dextrose) Used in Subjects With Normal and Elevated Pulmonary Artery Systolic Pressure (PASP. This is Per Sequence and Not a Cross-over Study.|"Observe subjects with normal pulmonary artery systolic pressure (PASP) and elevated pulmonary artery systolic pressure (PASP) as measured by any adverse events.
The number of participants were stratified based on a screening pulmonary artery systolic pressure (PASP). Subjects stratified by; 11 subjects that were Normal PASP and 19 subjects that were Elevated PASP.
This is per sequence and not a cross-over study."|During the injection and catheterization procedure, and for up to 24 hours post-injection|The number of participants were stratified based on a screening pulmonary artery systolic pressure (PASP). Subjects stratified by; Normal PASP and Elevated PASP.||Adverse Events|||Number
791628|NCT00878878|Primary|Observed the Change of Pulmonary Artery Systolic Pressure (PASP) Measured by Millimeters of Mercury (mm hg) Within Certain Time Periods. This is Per Sequence and Not a Cross-over Study.|Measurement of the Pulmonary artery systolic pressure (PASP) results, which were taken from the subject in millimeters of mercury; a unit of pressure (mm hg), at Baseline and at 2 minutes, 6 minutes and 10 minutes. This is per sequence and not a cross-over study.|Measurements recorded at Baseline, 2 minutes, 6 minutes and 10 minutes post contrast administration|The Pulmonary artery systolic pressure (PASP) results were taken at Baseline and at 2 minutes, 6 minutes and 10 minutes.||mm Hg||Standard Deviation|Mean
791629|NCT00879398|Secondary|Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics|Participants who were assessed as having improved from their baseline condition in the final efficacy assessment were considered as “effective”. Baseline and treatment characteristics included: geriatric status (<65 years or ≥65 years), age categories, gender, weight categories, height categories, allergic history, duration of disease, past overactive bladder (OAB) treatment history, medical history, kidney and liver disorders, concomitant medication, total administration period of Toviaz, completion status, daily dose of Toviaz, and long term administration of Toviaz (<274 days and ≥274 days) .|At the end of study treatment|PP Population||Percentage of Participants||95% Confidence Interval|Number
791630|NCT00879398|Secondary|Participant Perception of Bladder Condition at the End of Study Treatment|Participant perception of bladder condition was recorded in the CRF by the investigator. Participants were asked at baseline (BL) and at the end of study treatment (EOT) if the extent to which their bladder condition caused them problems. The possible responses were: No Problem, Very Minor Problems, Minor Problems, Moderate Problems, Severe Problems, or Many Severe Problems.|Baseline and at the end of study treatment|PP Population||Participants|||Number
791631|NCT00879398|Secondary|Change From Baseline in Number of UUI Episodes Per 24 Hours at the End of Study Treatment|The number of UUI episodes per 24 hours was recorded in the CRF by the investigator. Baseline was defined as data collected within 1 week prior to the first visit.|Baseline and at the end of study treatment|PP Population; n refers to the number of participants with evaluable data.||Number of Episodes per 24 Hours||Standard Deviation|Mean
791632|NCT00879398|Secondary|Change From Baseline in Number of Urgency Episodes Per 24 Hours at the End of Study Treatment|The number of urgency episodes per 24 hours was recorded in the CRF by the investigator. Baseline was defined as data collected within 1 week prior to the first visit.|Baseline and at the end of study treatment|PP Population; n refers to the number of participants with evaluable data.||Number of Episodes per 24 Hours||Standard Deviation|Mean
791633|NCT00879398|Secondary|Change From Baseline in Number of Micturitions Per 24 Hours at the End of Study Treatment|The number of micturitions per 24 hours was recorded in the case report form (CRF) by the investigator. Baseline was defined as data collected within 1 week prior to the first visit.|Baseline and at the end of study treatment|PP Population; n refers to the number of participants with evaluable data.||Number of Episodes per 24 Hours||Standard Deviation|Mean
791677|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Urine Protein).||Baseline up to Month 7|||percentage of participants|||Number
791634|NCT00879398|Primary|Investigator's Final Assessment of Effectiveness at the End of Study Treatment|The final efficacy assessment included improvement, no change, aggravation, and unevaluable evaluated by the investigator based on the subject's symptoms of frequent micturition, urgency, and urgency urinary incontinence (UUI).|At the end of study treatment|Per-Protocol (PP) Population: participants who had evaluable data and were eligible for the efficacy assessment of the approved indication. The method of last observation carried forward was used in the analysis of effectiveness endpoints.||Percentage of Participants|||Number
791635|NCT00879398|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)|An AE was any untoward medical occurrence in a clinical investigation subject administered a product or medical device; the event was not necessarily had a causal relationship with the treatment or usage. All AEs reported after start of administration of Toviaz were considered as TEAEs.|From the time that the participant signed data privacy statement through and including 28 calendar days after the last administration of the study drug.|Safety Analysis Set||Percentage of Participants|||Number
791636|NCT00879411|Secondary|Overall Tolerability Scale|Safety and tolerability of Micardis® in the treatment of patients with hypertension over 8 weeks, using 10 point Likert scale with worst score=1, best score=10|8 weeks|||units on a scale||Standard Deviation|Mean
791637|NCT00879411|Primary|Efficacy (Change of Diastolic Blood Pressure)|Change from baseline in 24h diastolic blood pressure (BP) at week 8|baseline to 8 weeks|||mm Hg||Standard Deviation|Mean
791638|NCT00879411|Primary|Efficacy (Change of Systolic Blood Pressure)|Change from baseline in 24h systolic blood pressure (BP) at week 8|baseline to 8 weeks|Intention to Treat (ITT)||mm Hg||Standard Deviation|Mean
791639|NCT00879619|Secondary|Qualitative and Quantitative Toxicity|Severity will be categorized by toxicity grade according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events v3.0 (CTCAE). Categorical analysis of toxicities will be performed.|Every 3 weeks and at study termination||||||
791640|NCT00879619|Secondary|Survival|Quantitative Kaplan-Meyer estimates of progression-free survival and overall survival will be determined.|At 2 and 3 years||||||
791641|NCT00879619|Secondary|Time to Progression (TTP) by PSA Response and Disease Response|Defined as an absolute increase in PSA of at least 2 ng/ml. For subjects with measurable disease, Response Evaluation Criteria In Solid Tumors (RECIST) criteria will be used. Significance of changes between pre- and after-treatment PSA or testosterone will be determined by the Wilcoxon signed-rank test. Associations between PSA response and tumor response will also be examined by Fisher's exact test.|Baseline, every 3 weeks, at study termination, and then for 3 years||||||
791642|NCT00879619|Secondary|Duration of Response (DR)|Response rates will be expressed with two-sided exact binomial confidence intervals.|Up to 3 years||||||
791643|NCT00879619|Secondary|Rates of Tumor Response (ORR)|Response rates will be expressed with two-sided exact binomial confidence intervals. The difference of response rates between different pre-treatment pathological stages or Gleason scores will also be examined by Fisher’s exact test. Associations between PSA response and tumor response will also be examined by Fisher’s exact test.|Every 2 months||||||
791644|NCT00879619|Primary|Prostate Specific Antigen (PSA) Response Rate|Defined by >= 30% decline in PSA from baseline for at least 3 months during study entry. Response rates will be expressed with two-sided exact binomial confidence intervals. Significance of changes between pre- and after-treatment PSA or testosterone will be determined by the Wilcoxon signed-rank test. Associations between PSA response and tumor response will also be examined by Fisher’s exact test.|Baseline, every 3 weeks, at study termination, and then for 3 years||||||
791645|NCT00879645|Secondary|Exhaled Sulfide||Baseline through day 2||||||
791646|NCT00879645|Secondary|Creatinine Clearance||Baseline, Day 7||||||
791647|NCT00879645|Secondary|Biochemistry||Baseline, Days 1, 2, and 7||||||
791648|NCT00879645|Secondary|Coagulation Factors||Baseline, Day 1, 2, and 7||||||
791649|NCT00879645|Secondary|12-lead ECG||Baseline, Day 0 through 7||||||
791650|NCT00879645|Secondary|Hematology||Baseline, Days 1 and 2||||||
791651|NCT00879645|Secondary|Urinalysis||Baseline, Days 1, 2, and 7||||||
791652|NCT00879645|Secondary|Vital Signs||Study duration||||||
791653|NCT00879645|Primary|Sodium Sulfide in Blood|Total concentration of sodium sulfide in blood was measured through pharmacokinetic blood sampling.|8 hours after treatment|||ng/mL||Standard Deviation|Mean
791654|NCT00879645|Primary|Thiosulfate in Urine|Total concentration of thiosulfate in urine was measure through pharmacokinetic urine collection|48 hours after treatment|||ng/mL||Standard Deviation|Mean
791655|NCT00879645|Primary|Thiosulfate in Plasma|Total concentration of thiosulfate in plasma was measured through pharmacokinetic blood sampling.|8 hours after treatment|||ng/mL||Standard Deviation|Mean
791656|NCT00879684|Secondary|Number of Participants With Best Overall Response (BOR)|BOR: best response recorded from treatment start until disease progression/recurrence based on Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): disappearance of all lesions. Partial Response (PR): >=30% decrease in sum of longest diameters (SLDs) of target lesions taking as reference baseline SLDs, associated to non-progressive disease (non-PD) response for non-target (NT) lesions. PD: >=20% increase in SLDs of target lesions taking as reference smallest SLDs since treatment start, or appearance of >=1 new lesion, or unequivocal progression in NT lesions. Stable disease (SD): neither shrinkage for CR/PR nor increase for PD taking as reference smallest SLDs since treatment start. CR and PR had to be confirmed on a follow up imaging assessment >=4 weeks after initial objective documentation of response. SD criteria should be met at least once after start of treatment in a minimum interval of 8 weeks. Participants with >=3 treatments cycles were reported.|Day 0 (predose), assessed every 8 weeks (2 cycles) until disease progression, unacceptable toxicity, or withdrawal for other reasons (up to Week 133)|Safety population included all enrolled participants in the study who received any study medication.||participants|||Number
791657|NCT00879684|Secondary|Number of Samples From Participants With Anti-CVX-060 Antibodies||Baseline (Day 0) up to 42 days after last dose|Anti-drug antibodies (ADA) analysis set included all participants who received at least 1 dose of CVX-060 and had PK data.||samples|Participants||Number
791658|NCT00879684|Secondary|Number of Participants With Anti-CVX-060 Antibodies||Baseline (Day 0) up to 42 days after last dose|Anti-drug antibodies (ADA) analysis set included all participants who received at least 1 dose of CVX-060 and had PK data.||participants|||Number
791659|NCT00879684|Secondary|Recommended Phase 2 Dose (RP2D): Stage 1|RP2D was determined as the highest dose where none out of 3 (0/3) or less than or equal to 1 out of 6 (<=1/6) participants experienced a dose limiting toxicity (DLT) or was determined based on the safety, pharmacokinetic, and pharmacodynamic findings. DLT was first course AE defined based on National Cancer Institute common toxicity criteria for adverse events version 3 (NCI-CTCAE Version 3) as any hematologic or non-hematologic toxicity greater than or equal to (>=) Grade 3.|Baseline (Day 0) up to 42 days after the last dose of study medication|Safety population included all enrolled participants in the study who received any study medication.||(mg/kg)/week|||Number
791660|NCT00879684|Secondary|Time to Reach Maximum Observed Serum Concentration (Tmax)||0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)|PK analysis set included all participants who received at least 1 dose of CVX-060 and had PK data.||hours||Full Range|Median
791661|NCT00879684|Secondary|Apparent Clearance (CL)|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes). Clearance obtained after intravenous infusion dose (apparent clearance) is influenced by the fraction of the dose absorbed.|0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)|PK analysis set included all participants who received at least 1 dose of CVX-060 and had PK data.||(mL/hr)/kg||Standard Deviation|Geometric Mean
791662|NCT00879684|Secondary|Apparent Volume of Distribution (Vss)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after intravenous infusion dose (Vss) is influenced by the fraction absorbed.|0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)|PK analysis set included all participants who received at least 1 dose of CVX-060 and had PK data.||milliliter per kilogram (mL/kg)||Standard Deviation|Geometric Mean
791663|NCT00879684|Secondary|Area Under the Curve From Time Zero to 168 Hours [AUC (0-168)]|AUC (0-168)= Area under the serum concentration versus time curve from time zero (pre-dose) to 168 hours after dosing (Day 7).|0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)|PK analysis set included all participants who received at least 1 dose of CVX-060 and had PK data.||nanogram*hour per milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
791664|NCT00879684|Secondary|Serum Decay Half-Life (t1/2)|Serum decay half-life is the time measured for the serum concentration to decrease by one half.|0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)|PK analysis set included all participants who received at least 1 dose of CVX-060 and had PK data.||hours||Standard Deviation|Mean
791665|NCT00879684|Secondary|Maximum Observed Serum Concentration (Cmax)||0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)|Pharmacokinetic (PK) analysis set included all participants who received at least 1 dose of CVX-060 and had PK data.||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
791666|NCT00879684|Primary|Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)|Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to CVX-060 was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.|Baseline (Day 0) up to 30 days after last dose of study medication|Safety population included all enrolled participants in the study who received any study medication.||participants|||Number
791667|NCT00879697|Primary|Total Walking Distance|The maximal walking distance|12 weeks|||meter||Standard Deviation|Mean
791668|NCT00879710|Secondary|Changes in Cholesterol Absorption or Synthesis Rates From the Baseline|We did not complete analyses of this outcome as we ran out of funds to measure these variables though samples have been collected.|6 weeks after initiation of drug therapy||||||
791669|NCT00879710|Primary|Changes in LDL Cholesterol|"Subjects with T1DM or T2DM were assigned to alternating therapy with simvastatin (40 mg) or ezetimibe (10 mg) for 6 weeks in a crossover design.
The data are reported as follows.
Subjects with type 1 diabetes mellitus:
Simvastatin: Changes in LDL after 6-week therapy with simvastatin (irrespective of the treatment order) Ezetimibe: Changes in LDL after 6-week therapy with ezetimibe (irrespective of the treatment order)
Subjects with type 2 diabetes mellitus:
Simvastatin: Changes in LDL after 6-week therapy with simvastatin (irrespective of the treatment order) Ezetimibe: Changes in LDL after 6-week therapy with ezetimibe (irrespective of the treatment order)"|6 weeks after starting drug therapy|||mmol/L||Standard Error|Mean
791670|NCT00879775|Primary|Numeric Rating of Scale (From 0 to 10) of Possible Sleep Disturbance of Opioids|Scores were measured by Numeric Rating Scale. Scores range from 0 to 10; a higher score represents a higher level of sleep disturbance.|two days|||scores|Participants|Standard Deviation|Mean
791671|NCT00879775|Secondary|Impact of Symptom Burden to Daily Life (by MD Anderson Symptom Inventory-Korean)|Scores were measured by Numeric Rating Scale. Scores range from 0 to 10; a higher score represents a higher level of impact of symptom burden to daily life.|two days|intention to treat||scores|Participants|Standard Deviation|Mean
791672|NCT00879775|Secondary|Health-related Quality of Life|Scores were measured by Numeric Rating Scale. Scores range from 0 to 10; a higher score represents a better health-related quality of life.|two days|intention to treat||scores|Participants|Standard Deviation|Mean
791673|NCT00879775|Secondary|Degree of Fatigue at the Point of Time With Numeric Rating Scale From 0 to 10|Scores were measured by Numeric Rating Scale. Scores range from 0 to 10; a higher score represents a higher level of fatigue.|two days|intention to treat||scores|Participants|Standard Deviation|Mean
791674|NCT00879775|Primary|Numeric Rating of Scale (From 0 to 10) of Pain and Possible Side Effects (Drowsiness, Confusion, Nausea) of Opioids|Scores were measured by Numeric Rating Scale. Scores range from 0 to 10; higher scores represent higher levels of pain, and possible side effects (drowsiness, confusion, nausea) of opioids.|two days|intention to treat||scores|Participants|Standard Deviation|Mean
791675|NCT00879814|Secondary|Meningococcal Immunoglobulin G (IgG) Geometric Mean Titers (GMT)||Before Dose 1, 1 month after Dose 2, before Dose 3, 1 month after Dose 3|||titers||95% Confidence Interval|Geometric Mean
791705|NCT00879970|Secondary|Mean Score on Montreal Cognitive Assessment (MoCA) Test, as an Assessment of Cognitive Function (CF)|CF was assessed with the 30-point (pt) MoCA test, involving a short-term memory recall task (T) (5 pts), a clock-drawing T (3 pts), a 3-dimensional cube copy (1 pt), a trail-making B T (1 pt), a phonemic fluency T (1 pt), a 2-item verbal abstraction T (2 pts), an attention T (1 pt), a serial subtraction T (3 pts), digits forward/ backward (1 pt each), a 3-item confrontation naming T (3 pts), repetition of 2 syntactically complex sentences (2 pts), and orientation to time/ place (6 pts). A score of 26 or above is normal.|From Randomization at Visit 3 to Final Visit (up to 162 days)|ITT Population. Study participation was placed on full clinical hold before data could be collected for this endpoint.|||||
791706|NCT00879970|Secondary|Mean Score on Euro-QoL (EQ)-5D|"Quality of life (QoL) was assessed by using the Euro-QoL (EQ)-5D, a short questionnaire used for measuring health-related QoL. The preference weights are elicited by asking participants to place hypothetical health states on a visual analogue scale from 0 to 1, whereby a score of 1 represents the best health state imaginable and 0 represents a health state equivalent to being dead. Negative states are those worse than being dead."|From Randomization at Visit 3 to Final Visit (up to 162 days)|ITT Population. Study participation was placed on full clinical hold before data could be collected for this endpoint.|||||
791707|NCT00879970|Secondary|Number of Participants With Erectile Dysfunction|Erectile dysfunction (ED) is sexual dysfunction characterized by the inability to develop or maintain an erection of the penis during sexual performance. ED was assessed by using the International Index of Erectile Dysfunction (IIED) questionnaire. This standardized and validated 15-item self-evaluation scale provides pre- and post-treatment clinic evaluations of erectile and orgasmic function, sexual desire, satisfaction with sexual intercourse, and general satisfaction.|From Randomization at Visit 3 to Final Visit (up to 162 days)|ITT Population. Study participation was placed on full clinical hold before data could be collected for this endpoint.|||||
791708|NCT00879970|Secondary|Number of Participants With Cognitive (Mental Processes) Decline (CD) From Baseline to the Year 2 Visit and the Final Visit|CD is equivalent to a difference of >=1.5 units on the Digit Symbol Substitution Test (DSST) score. The DSST is a neuropsychological test sensitive to brain damage, a serious loss of cognitive ability, age, and depression. It consists of digit-symbol pairs, followed by a list of digits. Under each digit the participant was asked to write the corresponding symbol as quickly as possible. The number of correct symbols within the allowed time (90 or 120 seconds) was measured in units (one correct score equals one unit).|From Randomization at Visit 3 to Final Visit (up to 162 days)|ITT Population. Study participation was placed on full clinical hold before data could be collected for this endpoint.|||||
791709|NCT00879970|Secondary|Number of Participants With Hepatic Enzyme Increased or Abnormal Liver Function Tests|"Liver function tests are groups of clinical biochemistry laboratory blood assays designed to give information about the health of the liver. Liver function test abnormal and hepatic enzyme increased were obtained from adverse event data as reported by investigators based on the reference range of the reporting local laboratory methodology. The vitamin D arm was not analyzed for this outcome measure."|From Randomization at Visit 3 to Final Visit (up to 162 days)|ITT Population||participants|||Number
791710|NCT00879970|Secondary|Number of Participants With a Fracture|Fracture is defined as a medical condition in which there is a break in the continuity of the bone. Fractures are defined as those breaks that are self reported plus confirmed by an X-ray. Data regarding all occurrences of any fracture were adjudicated by the EAC and sent to the IDMC on a regular basis for unblinded review.|From Randomization at Visit 3 to Final Visit (up to 162 days)|ITT Population||participants|||Number
791711|NCT00879970|Secondary|Number of Participants With Clinical Proteinuria|Clinical proteinuria is defined as a laboratory detection of urinary protein excretion > 0.5 grams (g) per 24 hours; spot urine analysis for albumin:creatinine ratio >=300 milligrams/g; timed urine collection for albumin excretion >=200 µg/minute or >=300 mg/24 hours. Clinical proteinuria data were obtained from outcomes reported by the site.|From Randomization at Visit 3 to Final Visit (up to 162 days)|ITT Population||participants|||Number
791712|NCT00879970|Secondary|Number of Participants With Severe Lower Than Normal Blood Glucose Level (Hypoglycemia)|Severe hypoglycemia is defined as hypoglycemia requiring assistance from another person with either a documented plasma glucose <=36 mg/deciliter (2.0 millimole per liter [mmol/L]) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration. Hypoglycemia data were obtained from outcomes reported by the site. Data regarding hypoglycemia were adjudicated by the EAC and sent to the IDMC on a regular basis for unblinded review.|From Randomization at Visit 3 to Final Visit (up to 162 days)|ITT Population||participants|||Number
791713|NCT00879970|Secondary|Number of Participants With Retinopathy Requiring Laser Therapy, a Decline in Estimated Glomerular Filtration Rate (eGFR), Vitrectomy, and Renal Replacement Therapy|Retinopathy is defined as damage to the inner lining of the eye (retina). Decline in eGFR is defined as a >=30% reduction in kidney function. Vitrectomy is a surgery to remove some or all of the fluid (vitreous humor) from the eye. Renal replacement therapy includes all the life-supporting treatments for renal failure. Data on the number of participants with all of these microvascular outcomes were collected at each visit. Data regarding the number of participants with these microvascular outcomes were adjudicated by the EAC and sent to the IDMC on a regular basis for unblinded review.|From Randomization at Visit 3 to Final Visit (up to 162 days)|ITT Population||participants|||Number
791714|NCT00879970|Secondary|Number of Participants With Composite Microvascular Outcome|The components of the composite microvascular outcome are retinopathy, decline in eGFR, vitrectomy, and renal replacement surgery. Retinopathy is defined as damage to the inner lining of the eye (retina). Decline in eGFR is defined as a >=30% reduction in kidney function. Vitrectomy is a surgery to remove some or all of the fluid (vitreous humor) from the eye. Renal replacement therapy includes all the life-supporting treatments for renal failure. Data regarding the number of participants with changes in micro blood vessels (composite microvascular outcome) were collected at each visit.|From Randomization at Visit 3 to Final Visit (up to 162 days)|ITT Population||participants|||Number
791752|NCT00880191|Secondary|Complete Response|The primary analysis described above was repeated using a slightly different alternate definition of complete response: no emetic episodes, no more than a mean of 2.5 on the nausea numeric analogue scale (0 - 10 (As bad as it could be)), and no rescue agents.|Days 2-6|||percentage of participants|||Number
791715|NCT00879970|Secondary|Number of Participants With Need for Hospitalization for Congestive Heart Failure (CHF), Shortness of Breath, Pneumonia, or Angina|CHF is a condition in which the heart is not able to pump adequate blood to meet the body's needs. Shortness of breath is defined as difficulty in breathing. Pneumonia is an infection of the lungs, caused by various microorganisms. Angina is defined as severe chest pain due to lack of adequate blood supply of the heart muscle because of obstruction/spasm of the heart's blood vessels. Data regarding the need for hospitalization due to any of these reasons were adjudicated by the EAC and sent to the IDMC on a regular basis for unblinded review.|From Randomization at Visit 3 to Final Visit (up to 162 days)|ITT Population||participants|||Number
791716|NCT00879970|Secondary|Number of Participants With Need for Hospitalization for Any Reason|Data regarding the need for hospitalization for any reason were collected and were then forwarded to the independent data monitoring committee (IDMC) on a regular basis for unblinded review.|From Randomization at Visit 3 to Final Visit (up to 162 days)|ITT Population||participants|||Number
791717|NCT00879970|Secondary|Number of Participants With Any Revascularization|Revascularization is defined as any surgical procedure for the provision of a new, additional, or augmented blood supply to heart muscle. Data regarding the need for any revascularization were adjudicated by the EAC and sent to the data monitoring committee (IDMC) on a regular basis for unblinded review.|From Randomization at Visit 3 to Final Visit (up to 162 days)|ITT Population||participants|||Number
791718|NCT00879970|Primary|Number of Participants With the Indicated Components of the Composite Outcome for Vitamin D|An EAC adjudicated all occurrences of the components of the composite outcome for vitamin D. Components are the first occurrence of death or cancer requiring hospitalization, treatment with medicines (chemotherapy), or surgery.|From Randomization at Visit 3 to Final Visit (up to 162 days)|ITT Population||participants|||Number
791719|NCT00879970|Primary|Number of Participants With the Indicated Components of the Composite Cardiovascular Outcome for Thiazolidinedione (TZD)|An event adjudication committee (EAC) adjudicated all occurrences of the components of the composite cardiovascular (CV; related to heart) outcome for TZD. Components are the first occurrence of cardiovascular death for which a non-heart-related cause has not been identified; non-fatal myocardial infarction (MI) (death of heart muscle from sudden blockage of a coronary artery by blood clot not leading to death); and non-fatal stroke (rapidly developing loss of brain function[s] due to disturbance in the blood supply to the brain not leading to death).|From Randomization at Visit 3 up to the Final Visit (average of 162 days)|Intent-to-Treat (ITT) Population: all randomized participants||participants|||Number
791720|NCT00879996|Secondary|Self-reported Illicit Opioid Use||6 months|||number of participants|||Number
791721|NCT00879996|Secondary|Numerical Rating Score for Functioning|We assessed functioning measured on a 0-10 point numerical rating scale (NRS)with 0 being the least amount of functioning and 10 the best amount of functioning.|6 months|The participants who completed the treatment were included in the statistical analysis.||units on a 0-10 point NRS scale||Standard Deviation|Mean
791722|NCT00879996|Secondary|Numerical Rating Score for Pain|Pain was measured using a 0-10 point numerical rating scale (NRS) with 0 representing no pain and 10 representing worst pain possible.|6 months|Participants that completed the treatment at 6 months were analyzed.||units on a 0-10 NRS scale||Standard Deviation|Mean
791723|NCT00879996|Primary|Number of Participants Retained in Treatment|This outcome assesses the number of participants who completed the treatment after 6 months.|6 months|All participants that were randomized were analyzed regarding their retention in treatment at 6 months.||participants|||Number
791724|NCT00880009|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)]|AUC (0-24)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-24).|0 hour (pre-dose) on Day 1; 2, 3, 4, 6, 8, 24 hours post-dose on Day 29|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.|||||
791725|NCT00880009|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 hour (pre-dose) on Day 1; 2, 3, 4, 6, 8, 24 hours post-dose on Day 29|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.|||||
791726|NCT00880009|Secondary|Maximum Observed Plasma Concentration (Cmax)||0 hour (pre-dose) on Day 1; 2, 3, 4, 6, 8, 24 hours post-dose on Day 29|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.|||||
791727|NCT00880009|Secondary|Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B)|FACT-B is used for assessment of health-related quality of life (QoL) in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and additional concerns on breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures ranges from 0=‘Not at all’ to 4=‘Very much’. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Part 2 Baseline, Week 12, 24, 52, 2-6 weeks after the last dose|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.|||||
791728|NCT00880009|Secondary|Duration of Response (DR)|Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Part 2 Baseline, every 8 weeks up to 2 to 6 weeks after last dose|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.|||||
791729|NCT00880009|Secondary|Overall Survival (OS)|Time in weeks from randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Part 2 Baseline until death or up to 36 months|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.|||||
791753|NCT00880191|Primary|Comparison of Percentage of Complete Responders|Complete response being defined as no emetic episodes and no use of rescue therapy for days 2 through 6. If a patient does not complete the study or does not provide complete data, they will be assumed to be a non-responder.|Days 2 through 6|||percentage of participants|||Number
791730|NCT00880009|Secondary|Percentage of Participants With Objective Response|Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as greater than or equal to >=30 percent (%) decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study >=4 weeks after initial documentation of response.|Part 2 Baseline, every 8 weeks up to 2 to 6 weeks after last dose|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.|||||
791731|NCT00880009|Secondary|Progression-Free Survival (PFS) Based on Investigator|"Time in weeks from date of randomization to first documentation of objective tumor progression or death due to any cause. PFS: calculated as (first event date minus the date of randomization plus 1) divided by 7. Tumor progression: determined from oncologic assessment data (where data meet the criteria for PD), or from AE data (where the outcome was Death). PFS assessed by investigator was to be reported."|Part 2 Baseline, every 8 weeks up to 2 to 6 weeks after last dose|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.|||||
791732|NCT00880009|Secondary|Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Part 1 Baseline up to 28 days after the last dose|Safety population included all participants who receive at least 1 dose of study treatment.||percentage of participants|||Number
791733|NCT00880009|Primary|Progression-Free Survival (PFS) Based on Independent Radiologist|"Time in weeks from date of randomization to first documentation of objective tumor progression or death due to any cause. PFS: calculated as (first event date minus the date of randomization plus 1) divided by 7. Tumor progression: determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death). PFS assessed by independent radiologist was to be reported."|Part 2 Baseline, every 8 weeks up to 2 to 6 weeks after last dose|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.|||||
791734|NCT00880022|Secondary|Symptom Improvement||end of scheduled treatments-day 30 of treatment||||||
791735|NCT00880022|Primary|Arm Volume at End of Study|measured by tape and then volume was calculated.|end of scheduled treatments-day 30 of treatment|Study withdrawals were not included.||ml||Inter-Quartile Range|Median
791736|NCT00880100|Post-Hoc|Percentage of Patients With Control of Steatorrhea Based on Concomitant Use of Proton Pump Inhibitors (PPIs)|Control of steatorrhea was defined as a less than 30 percent (%) of fat in stools as measured by nuclear magnetic resonance (NMR) spectroscopy in all stool samples which are collected in baseline phase (usual pancreatic enzymes) during which the patients were on their prescribed pancreatic enzyme product (PEP) and 5-day collection period of the treatment phase during which the PEP was replaced with Ultrase MT12.|A period of 19 to 24 days, from Baseline (Visit 2) to Day 15 to19 of Treatment Phase (Visit 3)|"The ITT population included all patients who signed an ICF and started the baseline phase. There was no imputation of missing data. Here n signifies patients who were evaluable for each specific category."||percentage of patients||95% Confidence Interval|Number
791737|NCT00880100|Other Pre-specified|Percentage of Days With Abdominal Pain and Excessive Flatulence|Mean percentage of days with abdominal complaints during baseline phase (BP) and the 5-day collection period of the treatment phase for total patients was summarized. Abdominal complaints were defined as the reporting of abdominal pain and/or unusual and excessive flatulence/gas production. Mean number of days abdominal pain (AP) and excessive flatulence (EF) in baseline phase (usual pancreatic enzymes) during which the patients were on their prescribed pancreatic enzyme product (PEP) and 5-day collection period of the treatment phase during which the PEP was replaced with Ultrase MT12, for total patients was summarized.|A period of 19 to 24 days, from Baseline (Visit 2) to Day 15 to19 of Treatment Phase (Visit 3)|"The ITT population included all patients who signed an ICF and started the baseline phase. Here n signifies patients who were evaluable for each specific category."||percentage of days||Standard Deviation|Mean
791738|NCT00880100|Other Pre-specified|Total Weight of Stools|The total weight of stools in grams (g) is the total weight obtained during the stool collection period regardless of the number of stools that had been collected during this same collection period. Mean total weight of stools in baseline phase (usual pancreatic enzymes) during which the patients were on their prescribed pancreatic enzyme product (PEP) and 5-day collection period of the treatment phase during which the PEP was replaced with Ultrase MT12, for total patients was summarized.|A period of 19 to 24 days, from Baseline (Visit 2) to Day 15 to19 of Treatment Phase (Visit 3)|"The ITT population included all patients who signed an ICF and started the baseline phase. Here N (number of patients analyzed) represents number of patients who were evaluable for this outcome measure. Here n signifies patients who were evaluable for each specified category."||gram (g)||Standard Deviation|Mean
791739|NCT00880100|Secondary|Mean Number of Days Without Abdominal Complaints|Abdominal complaints were defined as the reporting of abdominal pain and/or unusual and excessive flatulence/gas production. Mean number of days without abdominal complaints in baseline phase (usual pancreatic enzymes) during which the patients were on their prescribed pancreatic enzyme product (PEP) and 5-day collection period of the treatment phase during which the PEP was replaced with Ultrase MT12, for total patients was summarized.|A period of 19 to 24 days, from Baseline (Visit 2) to Day 15 to19 of Treatment Phase (Visit 3)|"The ITT population included all patients who signed an ICF and started the baseline phase. Here n signifies patients who were evaluable for each specified category."||days||Standard Deviation|Mean
791754|NCT00880230|Secondary|Target Limb Loss|Amputation of the target limb by surgical removal of tissue anywhere from the toe to hip in the ipsilateral limb of the target segment. Amputations are subclassified as: Above the knee, Below the knee, Transmetatarsal, and Toe.|9 Months|Intention to Treat Population (ITT)||Percentage of Patients|||Number
791740|NCT00880100|Secondary|Percentage of Stools With Abnormal Characteristics|Stools of abnormal characteristics were defined as bulky/large, foul-smelling and/or oily stools. Mean percentage of stools with abnormal characteristics in baseline phase (usual pancreatic enzymes) during which the patients were on their prescribed pancreatic enzyme product (PEP) and 5-day collection period of the treatment phase during which the PEP was replaced with Ultrase MT12, for total patients was summarized.|A period of 19 to 24 days, from Baseline (Visit 2) to Day 15 to19 of Treatment Phase (Visit 3)|"The ITT population included all patients who signed an ICF and started the baseline phase. Here n signifies patients who were evaluable for each specified category."||percentage of stools||Standard Deviation|Mean
791741|NCT00880100|Secondary|Percentage of Stools With Normal Consistency|Normal consistency of stool was defined as hard and formed or soft and formed consistency. Abnormal consistency was defined as loose and unformed stool or liquid stools and diarrhea. Percentage of stools with normal consistency of each patient was calculated from normal consistency of stools by the patient per day. Mean percentage of stools with normal consistency in baseline phase (usual pancreatic enzymes) during which the patients were on their prescribed pancreatic enzyme product (PEP) and 5-day collection period of the treatment phase during which the PEP was replaced with Ultrase MT12, for total patients was summarized.|A period of 19 to 24 days, from Baseline (Visit 2) to Day 15 to19 of Treatment Phase (Visit 3)|"The ITT population included all patients who signed an ICF and started the baseline phase. Here n signifies patients who were evaluable for each specified category."||percentage of stools||Standard Deviation|Mean
791742|NCT00880100|Secondary|Percentage of Patients With Normal Stool Frequency|Normal stool frequency was defined as having less than 4 bowel movements per day in baseline phase (usual pancreatic enzymes) during which the patients were on their prescribed pancreatic enzyme product (PEP) and 5-day collection period of the Treatment Phase during which the PEP was replaced with Ultrase MT12.|A period of 19 to 24 days, from Baseline (Visit 2) to Day 15 to19 of Treatment Phase (Visit 3)|"The ITT population included all patients who signed an ICF and started the baseline phase. Here n signifies patients who were evaluable for each specified category."||percentage of patients||95% Confidence Interval|Number
791743|NCT00880100|Primary|Percentage of Patients With Control of Steatorrhea|Control of steatorrhea was defined as a less than 30 percent (%) of fat in stools as measured by nuclear magnetic resonance (NMR) spectroscopy in all stool samples which are collected at baseline phase (usual pancreatic enzymes) during which the patients were on their prescribed pancreatic enzyme product (PEP) and during the 5-day collection period of the treatment phase during which the PEP was replaced with Ultrase MT12.|A period of 19 to 24 days, from Baseline (Visit 2) to Day 15 to19 of Treatment Phase (Visit 3)|The Intent-to-treat (ITT) population included all patients who signed an informed consent form (ICF) and started the baseline phase. The 50th percentile imputation method was used for missing data.||percentage of patients||95% Confidence Interval|Number
791744|NCT00880165|Secondary|Continuous Positive Airway Pressure Adherence|Mean daily hours of use of continuous positive airway pressure over the 3 month intervention|3 months|Participants diagnosed with obstructive sleep apnea who were prescribed continuous positive airway pressure (CPAP) treatment. Of the 148 individuals randomized to each arm, 110 in the in-lab testing arm and 113 in the home testing arm were prescribed CPAP. Results from these 223 subjects were used in the per protocol analysis.||hours per day||Standard Deviation|Mean
791745|NCT00880165|Secondary|Functional Outcome of Sleep Questionnaire|Change score from baseline of self-administered validate questionnaire of functional outcome following 3 months of positive airway pressure treatment|3 months|Participants diagnosed with obstructive sleep apnea who were prescribed continuous positive airway pressure (CPAP) treatment. Of the 148 individuals randomized to each arm, 110 in the in-lab testing arm and 113 in the home testing arm were prescribed CPAP. Results from these 223 subjects were used in the per protocol analysis.||units on a scale||Standard Deviation|Mean
791746|NCT00880165|Primary|Cost|VA sleep-study and treatment medical service use will be derived from the case report form; and costed out using VA acquisition costs. Other medical service use will be derived from VA administrative records. Non-VA medical service use will be derived from patient interview and will be costed out using federal reimbursement schedules. Costs will be stratified by whether or not they are related to the diagnosis and treatment of OSA.Cost and preferences are assessed for each entire arm.|Medical service use and cost will be collected every 3 months for the entire observation period. Thus the shortest duration of follow-up in the study is anticipated to be 3 months, while the longest will be 2.25 years.|Participants diagnosed with obstructive sleep apnea who were prescribed continuous positive airway pressure (CPAP) treatment. Of the 148 individuals randomized to each arm, 110 in the in-lab testing arm and 113 in the home testing arm were prescribed CPAP. Results from these 223 subjects were used in the per protocol analysis.||dollars|||Number
791747|NCT00880191|Secondary|Comparison of Daily Complete Response Endpoints|Daily complete response is defined as no emetic episodes and no use of rescue therapy.|Days 1 through 6|||percentage of participants|||Number
791748|NCT00880191|Secondary|Level of Satisfaction for the Control of Nausea.|Level of satisfaction for the control of nausea with the mean severity of nausea over the six days in the diary (on a 0 - 10 scale, higher the better) as well as the nausea subscale on the Functional Living Index – Emesis (FLIE) questionnaire ( 1-7 scale, lower the better)|Days 1 through 6|203 patients in Gabapentin arm and 201 patients in Placebo arm submitted the data for this endpoint.||units on a scale||Standard Deviation|Mean
791749|NCT00880191|Secondary|Comparison of Sum of the Daily Distress Questions as Well as the Individual Daily Responses|The sum of the daily distress questions as well as the individual daily responses from the Nausea and Vomiting Diary (NVD) on a 0-10 scale (Lower score is better) will be compared.|Days 1 through 6|||units on a scale||Standard Deviation|Mean
791750|NCT00880191|Secondary|Comparison of the Percentage of Patients Experiencing Emetic Episodes and the Percentage Needing Rescue Agents|The percentage of patients experiencing emetic episodes and the percentage needing rescue agents was compared between groups.|Days1 through 6|||percentage of participants|||Number
791751|NCT00880191|Secondary|Comparison of Percentages of Complete Responders on Day 1, vs. Days 1 Through 6 vs. Days 2 Through 6.|The percentages of complete responders on day 1, vs. days 1 through 6 vs. days 2 through 6 will be compared between arms. Complete response being defined as no emetic episodes and no use of rescue therapy. If a patient does not complete the study or does not provide complete data, they will be assumed to be a non-responder.|Days 1 through 6|||percentage of participants|||Number
791756|NCT00880230|Secondary|Restenosis Rate (≥ 50% Diameter Stenosis by Duplex Ultrasound Determination)|Restenosis is defined as a 50% or greater diameter stenosis observed post-procedure through the 9 month timepoint. Restenosis is initially assessed by Duplex Ultrasound of the iliac artery with the common femoral artery.|9 Months|||Percentage of Patients|||Number
791757|NCT00880230|Secondary|Target Limb Revascularization|Restenosis is defined as a 50% or greater diameter stenosis observed post-procedure through the 9 month timepoint. Restenosis is initially assessed by Duplex Ultrasound of the iliac artery with the common femoral artery.|9 Months|Intention to Treat Population (ITT)||Percentage of Patients|||Number
791758|NCT00880230|Secondary|Patency - Secondary|Secondary patency is defined as reestablishment of flow to distal arteries after 100% occlusion has occurred at the target vessel at post-procedure through 9 months.|9 Months|Intention to Treat Population (ITT)||Percentage of Patients|||Number
791759|NCT00880230|Secondary|Patency - Primary Assisted|Primary assisted patency is defined as continuous flow assisted with a revascularization when the target vessel has restenosed (0-99%) at any time post-procedure through 9 months.|9 Months|Intention to Treat (ITT)||Percentage of Patients|||Number
791760|NCT00880230|Secondary|Patency - Primary|Patients were assumed primary patent if the target vessel had continuous flow without revascularization, bypass, or amputation at 9 months.|9 Months|Intention to Treat (ITT)||Percentage of Patients|||Number
791761|NCT00880230|Secondary|Patency - Secondary|Secondary patency is defined as reestablishment of flow to distal arteries after 100% occlusion has occurred at the target vessel at post-procedure through 6 months.|6 Months|Intention to Treat Population (ITT)||Percentage of Patients|||Number
791762|NCT00880230|Secondary|Patency - Primary Assisted|Primary assisted patency is defined as continuous flow assisted with a revascularization when the target vessel has restenosed (0-99%) at any time post-procedure through 6 months.|6 Months|Intention to Treat (ITT)||Percentage of Patients|||Number
791763|NCT00880230|Secondary|Patency - Primary|Patients were assumed primary patent if the target vessel had continuous flow without revascularization, bypass, or amputation at 6 months.|6 Months|Intention to Treat Population (ITT)||Percentage of Patients|||Number
791764|NCT00880230|Secondary|Clinical Success|Late Clinical Success (9 months) is defined as a maintained improvement in Ankle-Brachial Index (ABI) or Thigh-Brachial Index (TBI) assessed as either a) normalized (0.90) or b) an increase by 0.1 from the baseline level and had not decreased by more than 0.15 from the maximum result observed immediately post-procedure. In the absence of ABI/TBI data, Late Clinical Success was assessed in the same manner as Early Clinical Success.|9 Months|Intent to Treat Population (ITT)||Percentage of Patients|||Number
791765|NCT00880230|Secondary|Clinical Success|Late Clinical Success (6 months) is defined as a maintained improvement in Ankle-Brachial Index (ABI) or Thigh-Brachial Index (TBI) assessed as either a) normalized (0.90) or b) an increase by 0.1 from the baseline level and had not decreased by more than 0.15 from the maximum result observed immediately post-procedure. In the absence of ABI/TBI data, Late Clinical Success was assessed in the same manner as Early Clinical Success.|6 Months|Intention to Treat Population (ITT)||Percentage of Patients|||Number
791766|NCT00880230|Secondary|Clinical Success|Early Clinical Success (30 days) is defined as improvement of the Rutherford-Becker scale criteria by greater than or equal to one category as obtained at the 30 day follow-up visit.|30 Days|Intention to Treat Population (ITT)||Percentage of Patients|||Number
791767|NCT00880230|Secondary|Procedural Success|The outcome is based on the successful delivery and deployment of the Scuba iliac stent and the intact retrieval of the delivery system [Device Success] and the achievement of <30% residual stenosis immediately after stent deployment, without occurrence of in-hospital Major Adverse Events (MAE).|Up to the moment the catheter sheath introducer has been removed|Intention to Treat Population (ITT)||Percentage of Patients|||Number
791768|NCT00880230|Secondary|Device Success|The outcome is based on the successful delivery and deployment of the Scuba iliac stent and the intact retrieval of the delivery system.|At time of deployment|Intent to Treat Population (ITT)||Percentage of Patients|||Number
791769|NCT00880230|Secondary|Major Adverse Vascular Events Through 30 Days as a Composite of (MI, Death or Stroke, Stent Thrombosis, Distal Embolization, Arterial Rupture/Perforation, Acute Limb Ischemia, Target Limb Loss, Procedure-related Bleeding Event Requiring Transfusion)|The analysis is based on the number of patients who experienced either an MI, died, had a stroke, stent thrombosis, distal embolization, arterial rupture/perforation limb ischemia, lost a target limb, or had a bleeding event due to the procedure within 30 days after being treated with the Scuba iliac stent.|30 Days|Intent to Treat Population (ITT)||Percentage of Patients|||Number
791770|NCT00880230|Primary|Composite of Major Adverse Events (MAE) Defined as the Occurrence of In-hospital Myocardial Infarction (MI) or Target Segment Revascularization, Target Limb Loss, or Death Within 9 Months Post-procedure.|The analysis is based on the percentage of Intent to Treat subjects (ITT) who experienced the primary endpoint or who had adequate follow-up for the 9-month analysis. A subject had adequate follow-up if he/she had an event or had a follow-up of at least 256 days, allowing for a visit window of 9 months +/- 14 days.|In-hospital and 9 Months|Intent to Treat Population (ITT)||Percentage of Participants|||Number
791771|NCT00880256|Secondary|Irritable Bowel Syndrome (IBS) Quality of Life|The IBS-QOL is a disease specific Quality-of-Life Measure for IBS. IBS-QOL has been shown have a high level of content validity and to be responsive to change, and has been used in several outcome studies and clinical drug trials throughout the world. It consists of 34 questions that assess the influence of bowel habits on daily life. The response to each question is rated on a 5-point scale. A lower score indicates worse bowel-related quality of life. The summed total score is transformed to a 0-100 scale ranging from 0 (poor quality of life) to 100 (maximum quality of life).|6 months|All participants who completed at 6 months were included||units on a scale||Standard Deviation|Mean
791806|NCT00880542|Primary|Using PET/CT Scan to Measure Safety, Toxicity, and Efficacy of Neoadjuvant Sorafenib Tosylate and Ifosfamide in Patients With Resectable High-grade Soft Tissue or Bone Sarcoma.|After cycle 1, a limited PET/CT scan of the affected site will be performed to assess response to sorafenib treatment alone. After cycle 3, prior to surgery, a limited PET/CT scan of the affected site will be performed to assess response to the combination sorafenib and ifosfamide treatment.|Participants were followed for duration of study, an average of 1 year.|Due to the study closing early and the few number of participants enrolled, the outcome measures were not done.|||||
791772|NCT00880256|Primary|IBS (Irritable Bowel Syndrome) Symptom Severity Score (Total Score)|The Irritable Bowel Severity Scoring System (IBSSS) provides a measure of the severity of IBS. The measure consists of five questions, which assess severity of abdominal pain, number of days with abdominal pain in past 10 days, severity of abdominal distension, satisfaction with bowel habits, and impact of IBS on life in general. The score on each of the 5 questions ranges from 0 to 100, and the scores are summed with a range of total possible scores from 0 to 500. Higher scores reflect more severe IBS. Total score was used in the analyses.|6 months|We compared scores at baseline, 2-month, and 6-month time points, using t-tests. A two-sided P value of less than 0.05 was considered statistically significant. The standardized mean difference (Cohen’s d effect size) from baseline to 2-months, and baseline to 6-months was calculated for each variable.||units on a scale||Standard Deviation|Mean
791773|NCT00880269|Secondary|Overall Survival Measured in Stratum A and B||6 treatment cycles (28-day/treatment cycle)|No secondary analyses were performed since study enrollment was stopped early at stage 1 for lack of evidence of activity.|||||
791774|NCT00880269|Secondary|Event-free Survival Measured in Stratum A and B||6 treatment cycles (28-day/treatment cycle)|No secondary analyses were performed since study enrollment was stopped early at stage 1 for lack of evidence of activity.|||||
791775|NCT00880269|Secondary|Duration of Remission Measured in Stratum A and B||6 treatment cycles (28-day/treatment cycle)|No secondary analyses were performed since study enrollment was stopped early at stage 1 for lack of evidence of activity.|||||
791776|NCT00880269|Secondary|Time to Remission Measured in Stratum A and B||6 treatment cycles (28-day/treatment cycle)|No secondary analyses were performed since study enrollment was stopped early at stage 1 for lack of evidence of activity.|||||
791777|NCT00880269|Secondary|Partial Response Measured in Stratum A and B|As predefined in the study's protocol, stage II was not pursued due to lack of activity (at end of stage I less than 4 patients in each stratum with CR/CRi)|6 treatment cycles (28-day/treatment cycle)|No secondary analyses were performed since study enrollment was stopped early at stage 1 for lack of evidence of activity.|||||
791778|NCT00880269|Primary|Best Response as Per Investigator Assessment by Stratum (FAS)|Response to treatment was defined as complete remission rate (CRR). CRR is complete remission (CR) and morphologic CR with incomplete blood count recovery (residual neutropenia or thrombocytopenia) (CRi). To stop or to proceed with Stage 2 of a given stratum of the Simon’s optimal 2-stage design was based on the number of patients with CR/CRi and a safety evaluation of the patients from Stage 1 in that stratum. If early results clearly indicated that the drug was not active or worthy of further investigation, enrollment of that particular stratum would be terminated. CR and CRi were assessed by the Investigator according to IWG response Criteria for AML (Cheson et al 2003). As per protocol we would continue to stage II if ≥ 4 patients out of 26 patients enrolled to stage I had a CR or a CRi. As per response observed there was only 1 patient with CR/CRi in stratum A and 2 patients with CR/CRi in Stratum B.|6 cycles of treatment with a 28-day treatment cycle (Day 168)|Full analysis set (FAS) is the same as the Safety set and includes all patients who received at least one dose of study drug. The FAS was used for final efficacy analyses.||Percentage of Participants|||Number
791779|NCT00880334|Post-Hoc|Disease Control Rate|Disease control rate is defined as the percentage of participants with confirmed overall Stable Disease (SD) or better using RECIST 1.0 criteria which parallels absence of disease progression (PD) on treatment. Per RECIST 1.0 for target lesions, PD is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or appearance of new lesions. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Patients without measurable disease only at baseline are included, based on status of non-target lesions.|Disease evaluations occurred at week 6 and 12 and thereafter every 3 cycles/9 weeks on treatment. Median treatment duration for this study cohort approximated 2 cycles (range 1-31).|||percentage of participants||95% Confidence Interval|Number
791780|NCT00880334|Secondary|Objective Response Rate|Objective response rate is defined as the percentage of participants who achieved a confirmed overall partial response (PR) or complete response (CR) using RECIST criteria on treatment. Patients without measurable disease only at baseline are included, based on status of non-target lesions.Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.|Disease evaluations occurred at week 6 and 12 and thereafter every 3 cycles/9 weeks on treatment. Median treatment duration for this study cohort approximated 2 cycles (range 1-31).|The analysis dataset is comprised of all eligible and treated patients.||percentage of participants||95% Confidence Interval|Number
791781|NCT00880334|Secondary|Median Overall Survival|Overall survival is defined from date of randomization to date of death or censored at the date the patient was last known alive.|Off treatment, patients were followed for survival information every 6 months (±1 month) until death,up to 2 years after discontinuing therapy, or until lost to follow-up. Median survival follow-up for the study cohort was 12 months (95% CI: 9-18 months).|The analysis dataset is comprised of all eligible and treated patients.||months||95% Confidence Interval|Median
791782|NCT00880334|Secondary|Grade 3-5 Toxicity Rate|Grade 3-5 toxicity rate is the percentage of participants experiencing maximum grade of all toxicity types of grade 3-5 with any attribution on treatment.|Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Median treatment duration for this study cohort approximated 2 cycles (range 1-31).|The analysis dataset is comprised of all eligible and treated patients.||percentage of participants||95% Confidence Interval|Number
791807|NCT00880555|Primary|FCI Score at Follow-up|At each research visit, participants undertook 5 portions of the Financial Capacity Instrument (Domains 2, 3, 4b, 5, and 7). We report the total FCI score across the five domains tested, which has a range of possible scores from 0-191. Higher scores reflect greater capacity for understanding financial concepts and handling financial tasks.|Year 1, Year 2, Year 3|Individuals completing at least one assessment following baseline||points awarded for correct items||Standard Deviation|Mean
791783|NCT00880334|Primary|Median Progression-Free Survival (PFS)|PFS based on the Kaplan-Meier method is defined as the time between randomization and documented disease progression (PD) per RECIST 1.0 criteria or death, or is censored at time of last disease assessment. Per RECIST 1.0 for target lesions, PD is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or appearance of new lesions. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|Disease evaluations occurred at week 6 and 12 and thereafter every 3 cycles/9 weeks on treatment and every 3 months in follow-up. Participants were followed until PD, death or lost to follow-up. Median survival follow-up was 12 months (range 1-26).|The analysis dataset is comprised of all eligible and treated patients.||months||95% Confidence Interval|Median
791784|NCT00880360|Secondary|Toxicity|Determine any toxicity associated with Ontak treatment in these patients.|3 years||||||
791785|NCT00880360|Primary|Number of Participants Demonstrating Clinical Response|Assess the efficacy of Ontak to treat selected advanced-stage ovarian epithelial cancers measured by clinical response rate, disease-free progression, and overall survival.|2 years|Measurements performed by RECIST criteria and response reported as a percent. 56 subjects needed to be recruited to the study to determine efficacy. Analysis was on an intent to treat basis.||participants|||Number
791786|NCT00880399|Secondary|Change From Baseline in the MSFQ Total Score-Females|The MSFQ is a self report rating scale derived from the Guided Interview Questionnaire for females and males. The questionnaire includes five questions with a score for each question ranging from 1 to 6 (1 = greater than normal; 2 = normal; 3 = minimally diminished; 4=moderately diminished; 5 = markedly diminished; and 6 = totally absent). The following four areas of sexual functioning were included: (1) diminished/absent libido; (2) arousal difficulties; (3) orgasm difficulties/anorgasmia; and (4) degree of sexual satisfaction. A total score (sum of individual question score) was used as a global measure of sexual dysfunction which ranged from 4 to 24, where 5 represents greater than normal functioning and 24 represents poorer function (worst outcome). Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. A negative change from Baseline was considered a positive outcome.|Baseline (Day 1) to Week 6|Only females from all subjects population. Only those participants available at the specified time points were analyzed.||Scores on a Scale||Standard Error|Least Squares Mean
791787|NCT00880399|Secondary|Change From Baseline in the Massachusetts Sexual Function Questionnaire (MSFQ)-Males|The MSFQ is a self report rating scale derived from the Guided Interview Questionnaire for females and males. The questionnaire includes five questions with a score for each question ranging from 1 to 6 (1 = greater than normal; 2 = normal; 3 = minimally diminished; 4=moderately diminished; 5 = markedly diminished; and 6 = totally absent). The following five areas of sexual functioning were included: (1) diminished/absent libido; (2) arousal difficulties; (3) orgasm difficulties/anorgasmia; (4) erectile dysfunction (males only) and (5) degree of sexual satisfaction. A total score (sum of individual question score) was used as a global measure of sexual dysfunction which ranged from 5 to 30, where 5 represents greater than normal functioning and 30 represents poorer function (worst outcome). Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. A negative change from Baseline was considered a positive outcome.|Baseline (Day 1) to Week 6|Only males from all subjects population. Only those participants available at the specified time points were analyzed.||Scores on a Scale||Standard Error|Least Squares Mean
791788|NCT00880399|Secondary|Number of Discontinuation-emergent Signs and Symptoms Using the Discontinuation-Emergent Signs and Symptoms (DESS)|The discontinuation signs and symptoms scale consists of 43 signs and symptoms, scored as ‘new symptom’, ‘old symptom but worse’, ‘old symptom but improved’ or ‘ symptom not present/old symptom but unchanged’. A frequency table for each symptom is reported by treatment and visit. The total number of new signs and symptoms, old symptoms but worse, old symptoms but improved and the total number of new or old-but-worse signs and symptoms are calculated for treatment and visit and reported.|Week 1 to Week 8/Follow up 1|All subjects population comprised of all participants who received at least one dose of study medication. Only those participants available at the specified time points were analyzed.||Signs and symptoms||Standard Deviation|Mean
791789|NCT00880399|Secondary|Number of Participants With Suicidal Behavior, Ideation, and Most Common Ideation Using the Columbia Suicidality Severity Rating Scale (C-SSRS)|The C-SSRS is a clinician-rated scale that evaluates severity and change of suicidality by integrating both behavior and ideation. It has 3 sections, Suicidal Behavior (SB), Suicidal Ideation (SI) and Intensity of Ideation (II). For SB, participants (par) were scored non-suicidal:0, preparatory acts or behavior communicating ideation:1, aborted attempt:2, interrupted attempt:3 or actual attempt:4 (most severe). For SI, par were scored non-suicidal:0, wish to be dead:1, non-specific active suicidal thoughts:2, active suicidal ideation with associated thoughts of methods without intent:3, active suicidal ideation with some intent to act on suicidal thoughts without clear plan:4, active suicidal ideation with plan and intent:5 (most severe). II scale made of 5 questions measuring frequency, duration, controllability, deterrent and reasons; par received a separate score on most common ideation and on most severe. Total II score is obtained by adding scores from all 5 questions.|Week 8|ITT Population. Only those participants available at the specified time points were analyzed.||Participants|||Number
791790|NCT00880399|Secondary|Number of Participants Who Remit (Have an Endpoint HAM-D Total Score <= 7) Who Continue to Show Symptoms on the HAM-D Sleep Items|A HAM-D remitter was defined as a participant with a HAM-D total score less than or equal to 7. The HAM-D was designed to measure the severity of depressive symptoms in participants with primary depressive illness. The scale is a checklist of items that are ranked on a scale of 0 to 4 or 0 to 2. Items with quantifiable severity are scored 0 to 4 (4 indicating the greatest severity) or 0 to 2 (2 indicating the greatest severity) with 0 indicating not present. The HAM-D Total Score is calculated by summing the individual response scores on the HAM-D questionnaire. The highest possible score is 52, which represents the most severe measure of depression; the lowest possible score is 0, which represents an absence of depression. The HAM-D is also useful for monitoring changes in depressive symptoms with treatment and in comparing the efficacy of various interventions if the participant requires more than one type of treatment.|Up to Week 6|ITT Population. Only those participants available at the specified time points were analyzed.||Participants|||Number
791808|NCT00880568|Primary|Number of Participants With Any Clinical or Laboratory Adverse Event|This is a measure of the number of participants who experienced any adverse event (AE) while on study.|First dose up to 30 days after last dose (up to 2 years)|All participants on study||participants|||Number
791791|NCT00880399|Secondary|Change From Baseline in MSQ Values for Sleep Quality (SQ) and Refreshing Value of Sleep (RVS)|The MSQ is a self-rated scale designed to assess effects on sleep and effects on next day functioning. The score relating to SQ and RVS was measured by items/questions 4 and 5 respectively of the MSQ. The following two variables SQ and RVS were assessed in order to determine effects on sleep. Participants were asked to rate their SQ and RVS on a scale of 1 to 10. This scale has no subscales. The total score for SQ and RVS, both, ranged from 1 to 10 where 1=poor and 10=excellent. Lower scores indicated poor SQ and RVS and higher scores indicated excellent SQ and excellent RVS. During the conduct of study, participants self-administered MSQ via an IVRS from their home the morning of each clinic visit. If a participant did not remember to place IVRS MSQ call the morning of the clinic visit from home, they were allowed to place call during in the clinic during their visit. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Day 1) to Week 6|ITT Population. Only those participants available at the specified time points were analyzed.||Scores on a Scale||Standard Error|Least Squares Mean
791792|NCT00880399|Secondary|Change From Baseline in MSQ Values for Number of Nocturnal Awakenings|The MSQ is a self-rated scale designed to assess effects on sleep and effects on next day functioning. The following six variables were assessed in order to determine effects on sleep: (1) total sleep time, (2) sleep onset latency, (3) number of nocturnal awakenings, (4) wake time after sleep onset, (5) sleep quality (where poor=1 and excellent= 10) and (6) the refreshing value of the sleep (where poor=1 and excellent= 10). During the conduct of the study, participants self-administered the MSQ via an Interactive Voice Response System (IVRS) from their home the morning of each clinic visit. Participants were provided paper MSQ diary cards for note taking prior to completing the IVRS call. If a participant did not remember to place the IVRS MSQ call the morning of the clinic visit from home, they were allowed to place the call during in the clinic during their visit. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Day 1) to Week 6|ITT Population. Only those participants available at the specified time points were analyzed.||Awakenings||Standard Error|Least Squares Mean
791793|NCT00880399|Secondary|Change From Baseline in Morning Sleep Questionnaire (MSQ) Values for Total Sleep Time (TST), Sleep Onset Latency (SOL) and Wake Time After Sleep Onset (WTSO)|The MSQ is a self-rated scale designed to assess effects on sleep and effects on next day functioning. The following six variables were assessed in order to determine effects on sleep: (1) total sleep time, (2) sleep onset latency, (3) number of nocturnal awakenings, (4) wake time after sleep onset, (5) sleep quality (where poor=1 and excellent= 10) and (6) the refreshing value of the sleep (where poor=1 and excellent= 10). During the conduct of the study, participants self-administered the MSQ via an Interactive Voice Response System (IVRS) from their home the morning of each clinic visit. Participants were provided paper MSQ diary cards for note taking prior to completing the IVRS call. If a participant did not remember to place the IVRS MSQ call the morning of the clinic visit from home, they were allowed to place the call during in the clinic during their visit. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Day 1) to Week 6|ITT Population. Only those participants available at the specified time points were analyzed.||Minutes (mins)||Standard Error|Least Squares Mean
791794|NCT00880399|Secondary|Change From Baseline in the Cognitive and Physical Function Questionnaire (CPFQ) Total Score|The CPFQ is a brief self-report scale which is designed to measure cognitive and executive dysfunction in mood and anxiety disorders. The scale comprises 7 questions assessing each of the most common complaints of depressed participants reporting fatigue or cognitive/executive problems. Each question is rated on a scale of 1 to 6, (1 = greater than normal; 2 = normal; 3 = minimally diminished; 4=moderately diminished; 5 = markedly diminished; and 6 = totally absent). The following five areas were included: motivation/interest/enthusiasm; wakefulness/alertness; energy; focus/sustain attention; remember/recall information; find words and sharpness/mental acuity. The total score (sum of individual question scores) ranged from 7 to 42. Lower score 7 represents greater than normal functioning and higher score 42 indicate poorer functioning (worst outcome). Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Day 1) and Week 6|ITT Population. Only those participants available at the specified time points were analyzed.||Scores on a Scale||Standard Error|Least Squares Mean
791795|NCT00880399|Secondary|Change From Baseline in the Clinical Global Impression-Severity of Illness (CGI-S) Score|The CGI is a widely accepted measure of illness severity and clinical improvement in a variety of psychiatric disorders. For the CGI-S, an independent site rater assessed the participant’s severity of illness considering (1) their total clinical experience with the particular population being studied and (2) information obtained during the Baseline HAM-D interview with the participant. The severity of illness (CGI-S) item is rated on a 1 to 7 scale such that 1 (normal, not at all ill) and 7 (among the most extremely ill). Higher scores indicate worsening. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Day 1) to Week 6|ITT Population. Only those participants available at the specified time points were analyzed.||Scores on a Scale||Standard Error|Least Squares Mean
791796|NCT00880399|Secondary|Percentage of Participants With Clinical Global Impression- Global Improvement (CGI-I) Score of 1 (Very Much Improved) or 2 (Much Improved)|The CGI is a widely accepted measure of illness severity and clinical improvement in a variety of psychiatric disorders. Global improvement (CGI-I) item is rated on a 1-7 scale. The CGI-I assessed scores range from 1 - very much improved to 7 - very much worse. For the CGI-I, the investigator or delegated qualified clinician indicated their assessment of the participant’s total improvement or worsening compared with the individual’s condition at the start of the study whether or not the change was judged to be due to drug treatment. A participant with a CGI-I score of 1 'very much improved' or 2 'much improved' was considered a responder. Percentage of responders are reported.|Up to Week 6|ITT Population. Only those participants available at the specified time points were analyzed.||Percentage of participants|||Number
791809|NCT00880568|Secondary|Mean AUC[0-24] of MK-1496 on Day 3 of Multiple Dose Administration (28-Day Cycle)|"AUC is a measure of the total plasma exposure of a drug. For this analysis, AUC was measured just prior to dosing and through 24 hours postdose on Day 3 of Weeks 1, 2, and 3 in Cycle 1. The AUC value presented is the mean AUC for all measurements.
AUC[0-24] for the Day 1 doses is reported as Outcome Measure 4."|Cycle 1, Day 3 (Hour 0 through Hour 24)|All participants in the first 28-day cycle||hr*nmol/L||Standard Deviation|Mean
791797|NCT00880399|Secondary|Change From Baseline in the HAM-D Anxiety Factor Score (Sum of Items 10, 11, 12, 13, 15 and 17)|The HAMD anxiety factor score includes 6 items/questions (item 10: anxiety psychic, item 11: anxiety somatic, item 12: somatic symptoms gastrointestinal, item 13: somatic symptoms general, item 15: hypochondriasis and item 17: insight). The items are rated on a scale of 0 to 4 (items 10, 11 and 15) or 0 to 2 (items 12, 13 and 17), higher scores reflecting greater severity. The highest possible score is 18, which represents the most severe measure of anxiety; the lowest possible score is 0, which represents an absence of anxiety. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Day 1) to Week 6|ITT Population. Only those participants available at the specified time points were analyzed.||Scores on a Scale||Standard Error|Least Squares Mean
791798|NCT00880399|Secondary|Change From Baseline in the 16-item Quick Inventory of Depressive Symptomatology (QIDS-SR 16) Total Score|The QIDS-SR is a self-report rating scale that assesses symptom severity of major depressive disorders. The QIDS-SR utilized during this study contained 16 separate items which correspond to 9 symptom criterion domains: (1) sad mood, (2) concentration, (3) self-criticism, (4) suicidal ideation,(5) interest, (6) energy/fatigue, (7) sleep disturbance (initial, middle, and late insomnia or hypersomnia), (8) decrease/increase in appetite/weight, and (9) psychomotor agitation/retardation. The QIDS-SR total score was calculated using the sum of the domain scores. The highest possible total QIDS-SR score is 27, which represents the most severe measure of depression. The lowest possible score is 0, which represents an absence of depression. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Day 1) to Week 6|ITT Population. Only those participants available at the specified time points were analyzed.||Scores on a Scale||Standard Error|Least Squares Mean
791799|NCT00880399|Secondary|Change From Baseline in the Bech Melancholia Scale Total Score (Sum of Items 1, 2, 7, 8, 10, and 13 of the 17-item HAMD Scale)|The Bech Melancholia is sum of scores on 6 items/questions (item 1: depressed mood, item 2: feelings of guilt, item 7: work and activities, item 8: retardation, item 10: anxiety psychic and item 13: somatic symptoms general) pertaining to melancholia within HAM-D. The items are rated on a scale of 0 to 4 (items 1, 2, 7, 8 and 10) or 0 to 2 (item 13), higher scores reflecting greater severity. The highest possible score is 24, which represents the most severe measure of melancholy; the lowest possible score is 0, which represents an absence of melancholy. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Day 1) to Week 6|ITT Population. Only those participants available at the specified time points were analyzed.||Scores on a Scale||Standard Error|Least Squares Mean
791800|NCT00880399|Secondary|Number of Participants With (Maintained) Clinical Response|Clinical response or antidepressant response was defined as >= 50% reduction from randomization in their HAMD total score, where this response was maintained until the end of the Treatment Phase (Week 6). Participants who met the >= 50% reduction at Week 6 without also having met it at Week 4 were not considered to have reached a maintained response, and therefore were censored at Week 6. Number of participants with maintained clinical response are reported.|Up to Week 6|ITT Population.||Participants|||Number
791801|NCT00880399|Secondary|Percentage of Participants With a >= 50 Percent (%) Reduction From Baseline in HAM-D Total Score|Participants who had 50% or greater reduction from Baseline in their total HAMD score were termed as responders. The HAM-D was designed to measure the severity of depressive symptoms in participants with primary depressive illness. The scale is a checklist of items that are ranked on a scale of 0 to 4 or 0 to 2. Items with quantifiable severity are scored 0 to 4 (4 indicating the greatest severity) or 0 to 2 (2 indicating the greatest severity) with 0 indicating not present. The HAM-D Total Score is calculated by summing the individual response scores on the HAM-D questionnaire. The highest possible score is 52, which represents the most severe measure of depression; the lowest possible score is 0, which represents an absence of depression. The HAM-D is also useful for monitoring changes in depressive symptoms with treatment and in comparing the efficacy of various interventions if the participant requires more than one type of treatment. Baseline was Day 1.|Baseline (Day 1) to Week 6|ITT Population. Only those participants available at the specified time points were analyzed.||Percentage of participants|||Number
791802|NCT00880399|Primary|Change From Baseline in the 17-item Hamilton Depression Rating Scale (HAM-D) Total Score|The HAM-D is designed to measure severity of depressive symptoms in participants with primary depressive illness. The scale is a checklist of items (1: depressed mood, 2: feelings of guilt, 3: suicide, insomnia early, 4: insomnia early, 5: insomnia middle, 6: insomnia late, 7: work and activities, 8: retardation, 9: agitation, 10: anxiety psychic item 10: anxiety psychic, item 11: anxiety somatic, item 12: somatic symptoms gastrointestinal, 13: somatic symptoms general, 14: genital symptoms, 15: hypochondriasis, 16: loss of weight and 17: insight) that are ranked on a scale of 0 to 4 or 0 to 2 (4 and 2: highly severe and 0: not present). The HAM-D total score is calculated by summing individual response scores on the HAM-D questionnaire. The highest possible score is 52, representing most severe measure of depression; lowest possible score is 0, representing no depression. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Day 1) to Week 6|The Intent-to-Treat (ITT) population comprised of all participants who were randomized and received at least one dose of double blind medication and for whom at least one post-randomization assessment was available. Only those participants available at the specified time points were analyzed.||Scores on a Scale||Standard Error|Least Squares Mean
791803|NCT00880425|Secondary|Number of Patient With Daily Headache Who Have Non-continuous Headache|Number of patient with Daily Headache who have non-continuous headache|Records were reviewed from April 2009 through June 2009|||participants|||Number
791804|NCT00880425|Primary|Number of Subjects With Daily Headache Who Have Continuous Headache|The number of subjects with Daily Headache who have continuous headache|Records were reviewed from April 2009 through June 2009|||participants|||Number
791805|NCT00880542|Secondary|Local and Distant Recurrence-free Survival||conclusion of study|Due to study closing early and the few number of participants enrolled, the outcome measures were not done.|||||
791810|NCT00880568|Secondary|Mean AUC[0-24] of MK-1496 on Day 1 of Multiple Dose Administration (28-Day Cycle)|"AUC is a measure of the total plasma exposure of a drug. For this analysis, AUC was measured just prior to dosing and through 24 hours postdose on Day 1 of Weeks 1, 2, and 3 in Cycle 1. The AUC value presented is the mean AUC for all measurements.
AUC[0-24] for the Day 3 doses is reported as Outcome Measure 5."|Cycle 1, Day 1 (Hour 0 through Hour 24)|All participants in the first cycle of the 28-day dosing schedule||hr*nmol/L||Standard Deviation|Mean
791811|NCT00880568|Secondary|Area Under the Curve From Hour 0 to Hour 24 (AUC[0-24]) for MK-1496 Single Dose (21-Day Cycle)|"AUC[0-24] is a measure of the total plasma exposure of drug over a 24-hour period after the initial dose; for this analysis AUC was measured on Day 1 of the first 21-day cycle.
AUC[0-24] for the 28-day cycle is reported as Outcome Measures 4 and 5."|Cycle 1, Day 1 (Hour 0 through Hour 24)|All participants on the 21-day dosing schedule||hr*nmol/L||Standard Deviation|Mean
791812|NCT00880568|Primary|Number of Participants With Dose-limiting Toxicities (DLTs)|Dose-limiting toxicities (DLTs) are any adverse events that are not clearly related to disease progression including Grade 4 neutropenia, Grade 3 or 4 febrile neutropenia, thrombocytopenic bleeding or Grade 4 thrombocytopenia, and any Grade 3 or 4 non hematologic toxicity. An adverse event (AE) is any unfavorable and unintended change in the structure and function (Clinical AE) or chemistry (Laboratory AE) of the body temporally associated with the use of study product, whether or not considered related to the use of the product.|Cycle 1 (up to 21 or 28 days, depending on treatment arm)|All participants in the first cycle of each dosing schedule (21 or 28 days)||participants|||Number
791813|NCT00880581|Secondary|Response Rate After Cycle 2|"Response after a second cycle of treatment was assessed per the Cheson Criteria, as below.
Complete Response (CR) = Complete disappearance of all lesions, evidence, and effects of disease
CR/unconfirmed (CRu) = residual lymph node mass >1.5 cm but regressed >75%, with 1 residual lymph node mass >1.5 cm that has regressed by >75% and/or increased number or size of bone marrow aggregates without cytologic or architectural atypia
Partial Response (PR) = ≥50% decrease in SPD of the 6 largest lesions with no increase in the size of the other nodes; splenic / hepatic nodules regress ≥50%, and with no new sites of disease Stable disease (SD) = less than PR."|6 months|Participants with progressive disease (PD) were not re-evaluated.||participants|||Number
791814|NCT00880581|Primary|Overall ObjectiveResponse (ORR) Rate|"Overall objective response rate (OOR) at time of best response was assessed as the sum of the Complete Response (CR) rate and the Partial Response (CR, PR) rate. Response was assessed per the Cheson Criteria, as below.
Complete Response (CR) = Complete disappearance of all lesions, evidence, and effects of disease
CR/unconfirmed (CRu) = residual lymph node mass >1.5 cm but regressed >75%, with 1 residual lymph node mass >1.5 cm that has regressed by >75% and/or increased number or size of bone marrow aggregates without cytologic or architectural atypia
Partial Response (PR) = ≥50% decrease in SPD of the 6 largest lesions with no increase in the size of the other nodes; splenic / hepatic nodules regress ≥50%, and with no new sites of disease Stable disease (SD) = less than PR."|12 weeks|||participants|||Number
791815|NCT00880620|Secondary|Summary of Change From Baseline to End of Study in Mean Parkinson's Disease Questionnaire-39 (PDQ-39) Score|"Change from Baseline in Parkinson's disease Questionnaire 39 (PDQ-39) at Weeks 4, 9, 16, 23 and 30 or early discontinuation was collected. The PDQ-39 is a self-reported questionnaire consisting of 39 questions regarding the subjects mobility and the responses consist of Never (better in outcome), (value 0), Occasionally (value 1), Sometimes (value 2), , Often (value 3), and Always (value 4), (worse in outcome). The minimum possible score is 0 and the maximum is 156. The outcome measure calculated was the change from baseline to end of study in mean PDQ-39 score. Negative values indicate a better result."|Baseline and Week 30 (or End of Study)|Subjects who had no postbaseline efficacy assessments (N=4) and those who had early termination assessments >3 days after last dose and no other postbaseline measurements (N=16) were not included in the efficacy analysis. 2 subjects without a baseline measurement, 1 each from 145mg and 390mg arm were also excluded. Randomized 381-4-16-2=359.||score on a scale||Standard Deviation|Mean
791816|NCT00880620|Primary|Change From Baseline in the Sum of UPDRS Part II + UPDRS Part III at Week 30|"Analysis of the Change from Baseline in the sum of the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) + UPDRS Part III (Motor Examination) at Week 30 (End of Study).
Unified Parkinson’s Disease Rating Scale (UPDRS) – Four Parts Higher score values represent a worse outcome.
Subscales II and III were summed:
Part I: Mentation, Behavior and Mood – 4 questions 1-4 Score range: 1-16 Part II: Activities of Daily Living – 13 questions 5-17 Score range: 0-52 Part III: Motor Examination – 19 questions 18-31 and 25 total assessments Score range: 0-100 Part IV: Complications of Therapy (In the past week) – 11 questions Score range: 0-25"|Week 30|Analysis included all treated subjects with at least one efficacy measurement after dosing. Subjects who had no post-baseline efficacy assessments (N4) and those who had early termination assessments>3 days after last dose and no other post-baseline measurements (N16) were not included in the efficacy analysis set. Randomized (381)-(4+16) = 361.||units on a scale||Standard Deviation|Mean
791817|NCT00880685|Secondary|Clinical Global Impression Severity Scales (CGI)|The overall impression of the clinician of the severity of the subject. Scores between 1 and 7 with 1 not being ill at all and 7 being one of the worst cases seen. CGI is given at baseline and weeks 2, 4, 6, and 8. Only the last visit (week 8) will be reported here.|Week 8 (last visit)|||units on a scale||Standard Deviation|Mean
791818|NCT00880685|Secondary|Kleptomania Symptom Assessment Scale (K-SAS)|Scale used to measure severity of kleptomania. Scores could range from 0-36 with 0 being the least severe and 36 being the most severe. Here the total score was used. The K-SAS was completed at every visit (1-5), but the final visit (visit 5) will be the only score reported. The scale was given at baseline and weeks 2, 4, 6, and 8. Only the last visit (week 8) will be reported here.|Week 8 (last visit)|||units on a scale||Standard Deviation|Mean
791819|NCT00880685|Primary|Yale Brown Obsessive Compulsive Scale Modified for KM (KM-YBOCS)|Scores could range from 0-40 with 0 being the least severe and 40 being the most severe. Here the total score was used. The KM-YBOCS was completed at every visit (1-5), but the final visit (visit 5) will be the only score reported. The scale was given at baseline and weeks 2, 4, 6, and 8. Only the last visit (week 8) will be reported here.|Week 8 (last visit)|||units on a scale||Standard Deviation|Mean
791827|NCT00880750|Secondary|Time of Maximum Plasma Concentration (Tmax) of Lanthanum Carbonate||3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose on Day 4|PK set||hours||Full Range|Median
791828|NCT00880750|Secondary|Maximum Plasma Concentration (Cmax) of Lanthanum Carbonate||3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose on Day 4|PK set||ng/ml||Standard Deviation|Mean
791829|NCT00880750|Secondary|Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lanthanum Carbonate||3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose on Day 4|Pharmacokinetic set (PK) includes all subjects who had sufficient post-dose blood samples taken to estimate Cmax and AUC 0-48 hours after dosing on Day 4 in all treatment periods. Subjects who vomited between dosing and 10 hours post-dose on Day 4 of any treatment period were excluded from the PK set.||ng*h/ml||Standard Deviation|Mean
791830|NCT00880750|Secondary|Urinary Phosphate Excretion on Day 4||Continuous collection on Day 4|PD set||mmol||Standard Error|Least Squares Mean
791831|NCT00880750|Primary|Urinary Phosphate Excretion 3-Day Average||Continuous collection over 3 days|Pharmacodynamic Set (PD) includes all subjects who completed all urine collections and consumed at least 95% of food in all treatment periods. Subjects who vomited from days -2 to 4 of any treatment period were excluded from the set.||mmol||Standard Error|Least Squares Mean
791832|NCT00880763|Secondary|Number of Participants Who Discontinued Study Drug Due to an Adverse Event|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.|Up to 6 weeks|The All Participants as Treated population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the treatment group corresponding to the study treatment they actually received.||Participants|||Number
791833|NCT00880763|Secondary|Number of Participants Who Experienced at Least One Adverse Event|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.|Up to 6 weeks|The All Participants as Treated population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the treatment group corresponding to the study treatment they actually received.||Participants|||Number
791834|NCT00880763|Secondary|Change From Baseline in HCV RNA in log10 at Week 4|Change from baseline in HCV RNA at Week 4 was calculated by subtracting Week 4 HCV RNA level from Baseline HCV RNA level. HCV RNA is measured as International Units per milliliter (IU/mL). Serum HCV RNA levels were measured using Roche COBAS TaqMan HCV Auto assay. The DAO approach was used to handle missing data.|Baseline and Week 4|Per protocol population excludes participants for important deviations from the protocol that may substantially affect the results of the primary efficacy analysis.||IU/mL in Log10||Standard Deviation|Mean
791835|NCT00880763|Secondary|Percentage of Participants Achieving a > or = 3-log10 Decrease in HCV RNA From Baseline to Week 4|Serum HCV RNA levels were measured using Roche COBAS TaqMan HCV Auto assay. The DAO approach was used to handle missing data.|Baseline and Week 4|Per protocol population excludes participants for important deviations from the protocol that may substantially affect the results of the primary efficacy analysis.||Percentage of participants|||Number
791948|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Ease of Application of Product at Weeks 1 and 2|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Very easy; 2, Easy; 3, Neutral; 4, Difficult.|Weeks 1 and 2|ITT||Units on a scale||Standard Deviation|Mean
791836|NCT00880763|Secondary|Percentage of Participants Achieving a > or = 2-log10 Decrease in HCV RNA From Baseline to Week 4|Serum HCV RNA levels were measured using Roche COBAS TaqMan HCV Auto assay. The DAO approach was used to handle missing data.|Baseline and Week 4|Per protocol population excludes participants for important deviations from the protocol that may substantially affect the results of the primary efficacy analysis.||Percentage of participants|||Number
791837|NCT00880763|Primary|Percentage of Participants Achieving Rapid Viral Response|Rapid viral response (RVR) is defined as undetectable hepatitis C virus ribonucleic acid (HCV RNA) at Week 4. Serum HCV RNA levels were measured using Roche COBAS TaqMan HCV Auto assay. The limit of quantification was 1.2 log IU/mL (15 IU/mL) and the limit of detection was <1.2 log IU/mL, but with no specific value. The Data-As-Observed (DAO) approach was used to handle missing data.|Week 4|Per protocol population excludes participants for important deviations from the protocol that may substantially affect the results of the primary efficacy analysis.||Percentage of participants|||Number
791838|NCT00880906|Secondary|Immunological Assessment Into the Etiology of Eosinophilic Esophagitis||60 days||||||
791839|NCT00880906|Primary|Percent Change From Baseline in Dysphagia Score in Patients With Eosinophilic Esophagitis (EE)|"Dysphagia Scores:
0 = able to eat normal diet / no dysphagia.
= able to swallow some solid foods
= able to swallow only semi solid foods
= able to swallow liquids only
= unable to swallow anything / total dysphagia"|60 days|||Percent Change|||Number
791840|NCT00880919|Primary|Sheehan Disability Scale (SDS)|Three self-rated items, on a scale of 0-10. 0 is unimpaired 10 is highly impaired This measures functional impairment|Change in functional impairment from Baseline to 8 weeks|All subjects randomly assigned to a treatment group were included in the intent-to-treat analyses of baseline demographic and clinical characteristics. The efficacy analyses were limited to subjects with at least one post-randomization observation to guarantee measurement of change.||units on a scale||Standard Error|Mean
791841|NCT00880919|Primary|Young Mania Rating Scale (YMS)|Eleven-item multiple choice diagnostic questionnaire, yielding total scores of 0-60. 0-4 rating 0-being least likely and 4 being most likely This scale assess manic symptoms|Change in manic symptoms from Baseline to 8 weeks|All subjects randomly assigned to a treatment group were included in the intent-to-treat analyses of baseline demographic and clinical characteristics. The efficacy analyses were limited to subjects with at least one post-randomization observation to guarantee measurement of change.||units on a scale||Standard Error|Mean
791842|NCT00880919|Primary|Symptom Checklist -90-Revised (SCL-90-R)|90 items measured on a Likert scale via self-report. Scale is 0-5 stating 0= strongly disagree and 5 is Strongly agree Measures psychological problems and symptoms|Change in psychological problems and symptoms from Baseline to 8 weeks|All subjects randomly assigned to a treatment group were included in the intent-to-treat analyses of baseline demographic and clinical characteristics. The efficacy analyses were limited to subjects with at least one post-randomization observation to guarantee measurement of change.||units on a scale||Standard Error|Mean
791843|NCT00880919|Primary|Barratt Impulsiveness Scale (BIS)|30-item self-report questionnaire, that is scored to yield a total score, three second-order factors, and six first-order factors. patients rate the questions 1-4 1 being the least and 4 being the most.|Change in Impulsiveness from Baseline to 8 weeks|All subjects randomly assigned to a treatment group were included in the intent-to-treat analyses of baseline demographic and clinical characteristics. The efficacy analyses were limited to subjects with at least one post-randomization observation to guarantee measurement of change.||units on a scale||Standard Error|Mean
791844|NCT00880919|Primary|Global Assessment of Functioning Scale (GAF)|Numeric scale (1 through 100) used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of adults. 100 is the highest level of functioning. O is the least functional|Change in Global Assessment of Functioning from Baseline to 8 weeks|All subjects randomly assigned to a treatment group were included in the intent-to-treat analyses of baseline demographic and clinical characteristics. The efficacy analyses were limited to subjects with at least one post-randomization observation to guarantee measurement of change.||units on a scale||Standard Error|Mean
791845|NCT00880919|Primary|Overt Aggression Scale - Modified (OAS-M)|Four part behavior rating scale designed to measure four types of aggressive behavior as witnessed in the past week. Each section consists of five questions. Total scores on the MOAS range from 0-40. 0 is the best and 40 is the worst of symptoms Reduction in scores shows a change of symptoms.|Change from Baseline Overt Aggression Scale - Modified to 8 weeks|All subjects randomly assigned to a treatment group were included in the intent-to-treat analyses of baseline demographic and clinical characteristics. The efficacy analyses were limited to subjects with at least one post-randomization observation to guarantee measurement of change.||units on a scale||Standard Error|Mean
791846|NCT00880919|Primary|Borderline Evaluation of Severity Over Time (BEST)|Scale including 15 items and three subscales. All items are rated on a Likert-like scale. A correction factor of 15 is added to yield the final score which can range from 12 (best) to 72 (worst).|Baseline to 8 weeks|All subjects randomly assigned to a treatment group were included in the intent-to-treat analyses of baseline demographic and clinical characteristics. The efficacy analyses were limited to subjects with at least one post-randomization observation to guarantee measurement of change.||units on a scale||Standard Error|Mean
791847|NCT00880919|Primary|Montgomery–Åsberg Depression Rating Scale (MADRS)|"Nine criteria rated on a six-point anchored rating scale of 0 to 6, yielding a total score of 0 to 60. O is the least and 6 is the highest
0 to 6 – normal /symptom absent 7 to 19 – mild depression 20 to 34 – moderate depression >34 – severe depression."|baseline to 8 weeks|All subjects randomly assigned to a treatment group were included in the intent-to-treat analyses of baseline demographic and clinical characteristics. The efficacy analyses were limited to subjects with at least one post-randomization observation to guarantee measurement of change.||units on a scale||Standard Error|Mean
791848|NCT00880919|Primary|Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD)|This is an assessment of change in DSM-IV borderline psychopathology. Consisting of nine criteria rated on a five-point anchored rating scale of 0 to 4, yielding a total score of 0 to 36. 0 being the best and 4 meaning the worse.|baseline, weekly until week 8|All subjects randomly assigned to a treatment group were included in the intent-to-treat analyses of baseline demographic and clinical characteristics. The efficacy analyses were limited to subjects with at least one post-randomization observation to guarantee measurement of change.||units on a scale||Standard Deviation|Mean
791849|NCT00881205|Primary|Change From Baseline to Week 16 in Total Recall on the Selective Reminding Test (SRT) in the Intent to Treat (ITT) Population|The Selective Reminding Test(SRT) is a test to assess verbal learning and memory. During the administration of the SRT only the examiner and the patient should be in the testing room. A list of twelve words is read aloud by the examiner at a rate of one word per two seconds. The patient is asked to recall all twelve words. Only the words that are missed on the preceding trial are given in the consecutive trial. The total score represents a sum score of 6 trials, therefore the range is from 0-72. The lower the value the worse the outcome.|After 16 weeks of treatment|Due to low enrollment numbers study did not achieve the anticipated 80% power.||units on a scale||Standard Deviation|Mean
791850|NCT00881335|Secondary|Number of Cases With Hospital Visit||up to 28 days|||participants|||Number
791851|NCT00881335|Primary|FEV1/FVC%, the Ratio of FEV1 to FVC|"indicators of pulmonary function,
All subjects sit upright in a chair and instructed to perform the pulmonary function test. Repeat the test until three reproducible acceptable results are obtained. Spirometry was performed at the first day of baseline and the 28th day of our study."|up to 28 days|||ratios||Standard Deviation|Mean
791852|NCT00881335|Primary|FVC, Forced Vital Capacity|"indicators of pulmonary function, for example, FVC(unit of measurement:Liter)
All subjects sit upright in a chair and instructed to perform the pulmonary function test. Repeat the test until three reproducible acceptable results are obtained. Spirometry was performed at the first day of baseline and the 28th day of our study."|up to 28 days|||L||Standard Deviation|Mean
791853|NCT00881335|Primary|FEV1, Forced Expiratory Volume at First Second|"indicators of pulmonary function, for example, FEV1(unit of measurement:Liter)
All subjects sit upright in a chair and instructed to perform the pulmonary function test. Repeat the test until three reproducible acceptable results are obtained. Spirometry was performed at the first day of baseline and the 28th day of our study."|up to 28 days|||L||Standard Deviation|Mean
791854|NCT00881335|Primary|MPEF,Mean Peak Expiratory Flow|indicators of pulmonary function, for example, PEF(unit of measurement:Liter per minute) All subjects sit upright in a chair and instructed to perform the pulmonary function test. Repeat the test until three reproducible acceptable results are obtained. Spirometry was performed at the first day of baseline and the 28th day of our study.|up to 28 days|||L/min||Standard Deviation|Mean
791855|NCT00881335|Secondary|Number of Cases With Antibiotics Therapy|antibiotics therapy is the indicators of pulmonary infection|up to 28 days|||participants|||Number
791856|NCT00881335|Primary|Number of Cases With Fever (Body Temperature Reach 38 Degree Celsius or Higher)||up to 28 days|||participants|||Number
791857|NCT00881465|Secondary|Clinical Global Improvement (CGI; Guy, 1976). The CGI is a 7-point Rating of Treatment Response Anchored by 1 (“Very Much Improved) and 7 (“Very Much Worse”).|Scores on this scale range from 1 to 7. Scores of 1 (very much improved) and 2 (much improved) are grouped together to indicate if a participate has had a beneficial response to the interview. The data represents participants who had a beneficial response to the treatment condition. Scores of 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse) and 7 (very much worse) are grouped together to indicate that a participant has not had a positive treatment response.|within one week after treatment condition was concluded|||participants|||Number
791858|NCT00881465|Secondary|Clinical Global Impression – Severity (CGI-S; National Institute of Mental Health, 1985). The CGI-S is a 7-point Clinician Rating of Severity of Psychopathology.|Scores on this scale range from 0 to 6 with higher scores corresponding to worse symptom severity.|within one week after treatment condition was concluded|||units on a scale||Standard Deviation|Mean
791859|NCT00881465|Primary|Children’s Yale-Brown Obsessive-Compulsive Scale (CY-BOCS; Scahill et al., 1997). The CY-BOCS is a 10-item Semi-structured Measure of Obsession and Compulsion Severity Over the Previous Week. This Measure Will Serve as the Primary Outcome Index.|Items on this scale are summed to arrive at a total score. Scores on this scale range from 0 to 40 with higher scores corresponding to worse symptom severity.|within one week after treatment condition was concluded|||units on a scale||Standard Deviation|Mean
791860|NCT00881504|Secondary|Safety and Toxicity|The number of patients who underwent FOLFOX dose reductions as a result of Grade 3 toxicity.|8 weeks|||participants|||Number
791861|NCT00881504|Primary|Progression-free Survival|Progression-free Survival is defined as the time from randomization (or study initiation) until objective tumor progression or death.|2 years|"Primary outcome of 4 participants out of 8 was undetermined due to several reasons including patient refusal of further follow up.
Of the 4 patients remaining for analysis, progression free survival of 34, 26.3, 7, and 4.7 weeks was seen."||weeks||Full Range|Median
791862|NCT00881530|Primary|Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements|Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements. New abnormal findings or worsening of baseline conditions were reported as treatment related Adverse Events.|78 weeks plus 1 week of follow-up|Treated set||percentage of participants|||Number
791863|NCT00881530|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) Over Time|Baseline source: before first intake of active treatment (preceding trial or Open label extension)|Weeks 1, 6, 18, 30, 42, 54, 66 and 78|Treated set||mg/dL||Standard Deviation|Mean
791864|NCT00881530|Secondary|Occurrence of a Relative Efficacy Response|Occurrence of a Relative Efficacy Response (HbA1c Lowered by at least >=0.5% over time)|Weeks 1, 6, 18, 30, 42, 54, 66 and 78|Treated set||percentage of participants|||Number
791865|NCT00881530|Secondary|Occurrence of a Treat-to-target Response (HbA1c < 6.5%)|Occurrence of a Treat-to-target Response, defined as HbA1c < 6.5% over time|Weeks 1, 6, 18, 30, 42, 54, 66 and 78|Treated set||percentage of participants|||Number
791866|NCT00881530|Secondary|Occurence of a Treat-to-target Response (HbA1c < 7.0%)|Occurence of a treat-to-target response, defined as HbA1c < 7.0% over time|Weeks 1, 6, 18, 30, 42, 54, 66 and 78|Treated set||percentage of participants|||Number
791867|NCT00881530|Secondary|Change From Baseline in HbA1c Over Time|Baseline source: before first intake of active treatment (preceding trial or Open label extension)|Weeks 1, 6, 18, 30, 42, 54, 66 and 78|Treated set||percentage of HbA1c||Standard Deviation|Mean
791868|NCT00881530|Primary|Change From Baseline to Week 78 in Lipid Parameters|Change from baseline to week 78 in lipid parameters (Total cholesterol, High-density lipoprotein (HDL), Low-density lipoprotein (LDL) and Triglyceride)|Weeks 1 and 78|Treated set||mmol/L||Standard Deviation|Mean
791869|NCT00881530|Primary|Hypoglycaemic Events|"Investigator defined Hypoglycaemic events. For documentation of hypoglycemic events, the following criteria were taken into consideration:
Asymptomatic hypoglycemia: the event was not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of ≤70 mg/dL (≤3.9 mmol/L)
Documented symptomatic hypoglycemia with glucose of ≥54 mg/dL and ≤70 mg/dL (≥3.0 mmol/L and ≤3.9 mmol/L)
Documented symptomatic hypoglycemia with glucose of <54 mg/dL (<3.0 mmol/L): the event was accompanied by typical symptoms of hypoglycemia but in no need for external assistance
Severe hypoglycemic episode: the event required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions"|78 weeks plus 1 week of follow-up|Treated set||percentage of participants|||Number
791870|NCT00881608|Secondary|Duration of Vaginal Bleeding Following Treatment With Proellex.||At least 2 days|Study prematurely terminated|||||
791871|NCT00881608|Primary|Day of Initial Vaginal Bleeding Event Following Treatment With Proellex.||An early vaginal bleeding event lasting at least two days and occurring on or before day 24 will be deemed to have achieved an induced menses|Study prematurely terminated|||||
791872|NCT00881621|Secondary|Adverse Events|Grade 3 or 4 toxicities|2 years|grade 3 or 4 toxicities||participants|||Number
791873|NCT00881621|Secondary|Progression Free Survival|Time of study entry to cancer progression.|24 months|Time of study entry to disease progression.||months||95% Confidence Interval|Median
791874|NCT00881621|Secondary|Clinical Benefit Response|"number of participants who had stable disease or partial response or complete response per Response Evaluation Criteria In Solid Tumors.
Complete Response: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
Partial Response: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Progressive Disease: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Stable Disease: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study."|3 months|||participants|||Number
791875|NCT00881621|Primary|Overall Survival|Time of study entry to time of death|24 months|||months||95% Confidence Interval|Median
791876|NCT00881647|Primary|Sleep Efficiency (SE)|SE, as determined by polysomnography (PSG) and by self-reported sleep diary, was the total sleep time (TST) divided by the time in bed, multiplied by 100. This outcome consists of posttreatment (CBT-I) or post-waitlist diary entries and polysomnography data; In other words, each of the values below was measured at 8 weeks.|After 8 weeks of study participation|||percentage of time||Standard Deviation|Mean
791877|NCT00881647|Primary|Minutes of Wake After Sleep Onset (WASO)|WASO was the sum of wake time during sleep as recorded in a self-report sleep diary, and as measured in epochs (30 seconds of polysomnography [PSG]) recording) after the onset of persistent sleep and prior to final awakening and wake time after sleep (the number of epochs after the final awakening until the end of PSG recording [i.e. awake epoch immediately prior to the end of the recording]). This outcome consists of posttreatment (CBT-I) or post-waitlist diary entries and polysomnography data; In other words, each of the values below was measured at 8 weeks.|After 8 weeks of study participation|per protocol||Minutes||Standard Deviation|Mean
791878|NCT00881647|Primary|Sleep Latency (SL)|In a self-report sleep diary, participants were asked to report the length of time it takes from lying down for the night until sleep onset. This outcome consists of the posttreatment (CBT-I) or post-waitlist diary entry; In other words, each of the values below was measured at 8 weeks.|After 8 weeks of study participation|||minutes||Standard Deviation|Mean
791879|NCT00881712|Secondary|Correlation of Functional CT-PET Imaging With Treatment Outcomes||Prestudy, before surgery (if applicable) between days 18-22 if needed, then during follow-up every 6 months for 2 years, then annually for 4 years|This data was not collected as study was terminated early.|||||
791880|NCT00881712|Secondary|Feasibility, Safety and Efficacy of Delivering Proton Radiotherapy With Concomitant Chemotherapy||Weekly during treatment, then every 3 months for 1 year, every 4 months for 2 years, every 6 months for 2 years, then annually|This data was not collected as study was terminated early.|||||
791881|NCT00881712|Secondary|Percentage of Patients Alive at 5 Years||Five years following radiation treatment|Thirteen enrolled patients that completed treatment.||percentage of patients|||Number
791882|NCT00881712|Secondary|Percentage of Patients With Disease Control|"Disease control rate is defined as Complete Response (CR) + Partial Response (PR) + Stable Disease (SD). As per RECIST version 1.1, Complete Response (CR): Disappearance of all target lesions, Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.), as accurate."|Following treatment every 6 months for 2 years, then annually for 4 years.|Thirteen enrolled patients that completed treatment||percentage of participants|||Number
791883|NCT00881712|Primary|Grade 3 or Higher Rate of Non-hematologic, Acute Treatment-related Toxicities||Six months after end of radiation therapy|||participants|||Number
791884|NCT00881751|Secondary|Response Rate|Secondary outcome measures include response rate as assessed on restaging imaging studies utilizing RECIST 1.1.|From day 1 drug administration until 30 days after the last dose of study drug.|Responders include complete and partial responders defined by RECIST 1.1 criteria.||percentage of participants|||Number
791885|NCT00881751|Secondary|Number of SAEs Experienced|The study will report the number of SAEs experienced in each arm. All patients who receive any study drug will be evaluable for toxicity.|From day 1 of drug administration until 30 days after the last dose of study drug.|Patients who received at least one dose of study drug were included in this analysis.||serious adverse events|||Number
791886|NCT00881751|Secondary|Event-free Survival|EFS is defined as the time from randomization to any of the following three types of events: 1 - progression; 2 - withdrawal due to excessive toxicity; 3 - any other clinical event requiring withdrawal from the study.|From the time of randomization until progression, withdrawal due to toxicity or any other clinical event requiring withdrawal from the study.|||Months||95% Confidence Interval|Median
791887|NCT00881751|Primary|Overall Survival|Overall survival is defined as the time from treatment day 1 until death from any cause. Patients still alive at the end of follow up,patients who withdrew consent from the trial and patients who were lost to follow up will have their survival time censored at the last date of contact.|from date of day 1 until the date of death|Only subjects who received one dose of study drug were considered for this outcome. 5 subjects enrolled to Arm II did not receive any study drug and were not evaluable for this outcome.||Months||95% Confidence Interval|Median
791888|NCT00881868|Primary|Number of Participants Who Were a Success or Failure Based on the Global Severity Score (GSS) of Scalp Psoriasis From Baseline to End of Treatment (Week 4 or Week 2 if Clear)|Number of participants who were a success or failure based on the Global Severity Score (GSS) of Scalp Psoriasis from baseline to end of treatment (Week 4 or Week 2 if Clear). GSS is evaluated on a scale from 0 - 5 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe, 5 = Very Severe) with 0 being best and 5 being worst. Success is defined as Clear or Almost Clear. (Note: 5 Clobex Spray subjects and 0 Vehicle Spray subjects were Clear at week 2 and their results were carried forward to week 4).|baseline to week 4|ITT, LOCF||participants|||Number
791889|NCT00881868|Secondary|Number of Participants in Each Category of Pruritus at Baseline and Week 4|Number of participants in each category of Pruritus at end of treatment (week 4 or week 2 if GSS was Clear). Pruritus is evaluated on a scale from 0 - 3 (0 = None, 1 = Mild, 2 = Moderate and 3 = Severe) with 0 being best and 3 being worst.|baseline to week 4|||participants|||Number
791890|NCT00881868|Secondary|Number of Participants in Each Category of the Extent of Scalp Involvement Index at Baseline and Week 4|Number of participants in each category of the Extent of Scalp Involvement Index at end of treatment (week 4 or week 2 if GSS was Clear). The Extent of Scalp Involvement Index is evaluated on a scale from 0 - 5 (0 = None, 2 = <20%, 2 = 20-39%, 3 = 40-59%, 4 = 60-79% and 5 = 80-100%) with 0 being best and 5 being worst.|baseline to week 4|||participants|||Number
791891|NCT00881868|Secondary|Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4|Number of participants in each category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at baseline and end of treatment (week 4 or week 2 if GSS is Clear). Individual Sign Scores are evaluated on a scale from 0 - 4 (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe and 4 = Very Severe) with 0 being best and 4 being worst.|baseline to week 4|||participants|||Number
791892|NCT00881894|Secondary|Apparent Dose|Apparent dose of unconjugated rotigotine in mg. The Apparent dose of unconjugated rotigotine was determined from the patches removed on Day 2.|48 hours|Pharmacokinetic Set (PKS)||mg||Standard Deviation|Mean
791893|NCT00881894|Secondary|CL/f of Unconjugated Rotigotine|The CL/f is the apparent total body clearance.|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)||L/ h||Standard Deviation|Mean
791894|NCT00881894|Secondary|t1/2 of Unconjugated Rotigotine|The t1/2 is the terminal half- life.|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)||hour (h)||Standard Deviation|Mean
791895|NCT00881894|Secondary|λz of Unconjugated Rotigotine|The λz is the rate constant of elimination.|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)||1/ hour (1/h)||Standard Deviation|Mean
791896|NCT00881894|Secondary|MRT of Unconjugated Rotigotine|The MRT is the mean residence time.|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24(before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)||hour (h)||Standard Deviation|Mean
791897|NCT00881894|Secondary|Tmax of Unconjugated Rotigotine|The Tmax is the time to reach a maximum plasma concentration after patch application.|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)||hour (h)||Full Range|Median
791898|NCT00881894|Secondary|Cmax,Norm (BW) of Unconjugated Rotigotine|The Cmax,Norm (BW) is the maximum plasma concentration normalized by body weight (kg).|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)||(ng/ mL)*kg||Standard Deviation|Mean
791899|NCT00881894|Secondary|Cmax,Norm (Apparent Dose) of Unconjugated Rotigotine|The Cmax,Norm (Apparent dose) is the maximum plasma concentration normalized by apparent dose.|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)||(ng/ mL) / mg||Standard Deviation|Mean
791900|NCT00881894|Secondary|AUC(0-tz)Norm (BW) of Unconjugated Rotigotine|The AUC(0-tz)Norm (BW) is the area under the plasma concentration- time curve from zero up to the last analytically quantifiable concentration normalized by body weight (kg).|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)||(ng/ mL)*h*kg||Standard Deviation|Mean
791901|NCT00881894|Secondary|AUC(0-tz)Norm (Apparent Dose) of Unconjugated Rotigotine|The AUC(0-tz)Norm (Apparent dose) is the area under the plasma concentration- time curve from zero up to the last analytically quantifiable concentration normalized by apparent dose (mg).|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)||(ng/ mL)*(h/ mg)||Standard Deviation|Mean
791902|NCT00881894|Secondary|AUC(0-∞) of Unconjugated Rotigotine|The AUC(0-∞) is the area under the plasma concentration- time curve from zero up to infinity.|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)||(ng/ mL)*h||Standard Deviation|Mean
791903|NCT00881894|Primary|Cmax of Unconjugated Rotigotine|The Cmax is the maximum plasma concentration.|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)||ng/ mL||Standard Deviation|Mean
791904|NCT00881894|Primary|AUC(0-tz) of Unconjugated Rotigotine|The AUC(0-tz) is the area under the plasma concentration- time curve from zero up to the last analytically quantifiable concentration.|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application|Pharmacokinetic Set (PKS)||(ng/ mL)*h||Standard Deviation|Mean
791905|NCT00887341|Secondary|Percentage of Participants With Improvement of at Least 0.22 in HAQ-DI|HAQ-DI is a self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessment based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ-DI scores range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ-DI total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation. An improvement of 0.22 units in HAQ-DI was considered to be a clinically significant improvement.|Weeks 4, 8, 12, 16, 20 and Final Visit|ITT Population||percentage of participants|||Number
791906|NCT00887341|Secondary|HAQ-DI Score by Visit|HAQ-DI is a self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessment based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ-DI scores range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ-DI total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation.|Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||units on a scale||Standard Deviation|Mean
791907|NCT00887341|Secondary|Erythrocyte Sedimentation Rate|ESR is an acute phase reactant measured in mm/hr. Reduction in ESR indicates improvement.|Baseline, Weeks 2, 4, 8, 12,16, 20, and 24|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||mm/hr||Standard Deviation|Mean
791908|NCT00887341|Secondary|C-Reactive Protein (CRP) Levels|CRP is an inflammation marker. High levels of this protein indicate inflammation in diseases such as Rheumatoid Arthritis. CRP is measured in milligrams per liter (mg/L).|Screening, Baseline, Weeks 4, 8, 12, 16, 20, and Final Visit|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||mg/L||Standard Deviation|Mean
791909|NCT00887341|Secondary|Percentage of Participants Achieving ACR 90% Improvement (ACR90 Response)|ACR90 response defined as an improvement of ≥90% in SJC (66 joints) and TJC (68 joints) as well as ≥90% improvement in at least 3 of the following 5 remaining ACR assessments: Patient Global Assessment of Pain; Patient Global Assessment of Disease Activity; Physician Global Assessment of Disease Activity; HAQ-DI; and acute phase reactive factors (ESR or CRP).|Weeks 4, 8, 12, 16, 20 and Final Visit|ITT Population||percentage of participants|||Number
791910|NCT00887341|Secondary|Percentage of Participants Achieving ACR 70% Improvement (ACR70 Response)|ACR70 response defined as an improvement of ≥70% in SJC (66 joints) and TJC (68 joints) as well as ≥70% improvement in at least 3 of the following 5 remaining ACR assessments: Patient Global Assessment of Pain; Patient Global Assessment of Disease Activity; Physician Global Assessment of Disease Activity; HAQ-DI; and acute phase reactive factors (ESR or CRP).|Weeks 4, 8, 12, 16, 20 and Final Visit|ITT Population||percentage of participants|||Number
791911|NCT00887341|Secondary|Percentage of Participants Achieving ACR 50% Improvement (ACR50 Response)|ACR50 response defined as an improvement of ≥50% in SJC (66 joints) and TJC (68 joints) as well as ≥50% improvement in at least 3 of the following 5 remaining ACR assessments: Patient Global Assessment of Pain; Patient Global Assessment of Disease Activity; Physician Global Assessment of Disease Activity; HAQ-DI; and acute phase reactive factors (ESR or CRP).|Weeks 4, 8, 12, 16, 20 and Final Visit|ITT Population||percentage of participants|||Number
791912|NCT00887341|Secondary|Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) Improvement (ACR20 Response)|ACR20 response defined as an improvement of ≥20% in swollen joint count (SJC; 66 joints) and tender joint count (TJC; 68 joints) as well as ≥20% improvement in at least 3 of the following 5 remaining ACR assessments: Patient Global Assessment of Pain; Patient Global Assessment of Disease Activity; Physician Global Assessment of Disease Activity; Health Assessment Questionnaire - Disability Index (HAQ-DI); and acute phase reactive factors (ESR or C-Reactive Protein [CRP])|Weeks 4, 8, 12, 16, 20 and Final Visit|ITT Population||percentage of participants|||Number
791913|NCT00887341|Secondary|DAS28 Score by Visit|DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hr) and Patient's Global Assessment of Disease (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 ≤3.2=low disease activity, DAS28 >3.2 to 5.1=moderate to high disease activity; DAS28 <2.6=remission. Last observation carried forward (LOCF) visit took the last non-missing post-baseline available value.|Weeks 4, 8, 12, 16, 20, and Final Visit|ITT Population; n (number)=number of participants analyzed for the specified parameter at a given visit.||units on a scale||Standard Deviation|Mean
791914|NCT00887341|Secondary|Percentage of Participants Achieving a DAS28 Score <2.6 (Remission)|DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hr) and Patient's Global Assessment of Disease (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 ≤3.2=low disease activity, DAS28 >3.2 to 5.1=moderate to high disease activity; DAS28 <2.6=remission.|Weeks 4, 8, 12, 16, 20 and Final Visit|ITT population||percentage of participants|||Number
791915|NCT00887341|Secondary|Percentage of Participants Achieving a DAS28 Score <3.2 by Visit|DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hr), and Patient's Global Assessment of Disease (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 ≤3.2=low disease activity, DAS28 >3.2 to 5.1=moderate to high disease activity; DAS28 <2.6=remission.|Weeks 4, 8, 12, 16, 20 and Final Visit|ITT Population||percentage of participants|||Number
791945|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Comfort of Skin at Week 8|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Very Comfortable; 2, Comfortable; 3, Somewhat Comfortable; 4, Somewhat Uncomfortable; 5, Uncomfortable.|Week 8|ITT||Units on a scale||Standard Deviation|Mean
791916|NCT00887341|Secondary|Percentage of Participants With a Reduction of at Least 1.2 Units on the Disease Activity Scale Based on 28-Joint Count (DAS28) by Visit|DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and Patient's Global Assessment of Disease (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 less than or equal to (≤)3.2 equals (=) low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity; DAS28 less than (<) 2.6 = remission. A reduction of at least 1.2 units was considered a clinically significant difference.|Weeks 4, 8, 12, 16, 20 and Final Visit|ITT Population||percentage of participants|||Number
791917|NCT00887341|Secondary|Percentage of Participants Discontinuing Tocilizumab for Any Reason||Weeks 4, 8, 12, 16, 20 and Final Visit|ITT Population||percentage of participants|||Number
791918|NCT00887341|Secondary|Percentage of Participants Discontinuing Tocilizumab in Response to an AE or Serious AE (SAE)||Weeks 4, 8, 12, 16, 20 and Final Visit|ITT Population||percentage of participants|||Number
791919|NCT00887341|Primary|Percentage of Participants With an Infusion Reaction Within 24 Hours After Infusion|An infusion reaction was defined as any adverse event (AE) that occurred during the infusion or during the 24 hours following the infusion.|Screening, Baseline, and Weeks 4, 8, 12, 16, 20, and 24|ITT Population||percentage of participants|||Number
791920|NCT00887354|Secondary|"Timed Up and Go Test"|"Timed Up and Go test measures, in seconds, the time taken by an individual to stand up from a standard chair, walk a distance of 3 meters, turn, walk back to the chair, and sit down. Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for age, type of fracture (31-A1/31-A2), type of reduction (open/close), type of walking aid, baseline SF-36 PCS and baseline Charnley’s pain score."|6, 12, 18, and 26 Weeks|All randomized participants receiving at least one dose of study drug and with at least one post-baseline efficacy measure.||seconds (sec)||Standard Error|Least Squares Mean
791921|NCT00887354|Secondary|Visual Analog Scale (VAS)|Visual analog pain scale is a measurement instrument to measure the level of hip pain. Scores range from 0 to 100 millimeter (mm) with higher score indicating greater pain. Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for type of fracture (31-A1/31-A2), type of reduction (open/close), use of opioids (Yes/No), use of non-steroidal anti-inflammatory drugs, adequate reduction (Yes/No) and interaction between treatment and adequate reduction.|6, 12, 18, and 26 Weeks|All randomized participants receiving at least one dose of study drug and with at least one post-baseline efficacy measure.||millimeter (mm)||Standard Error|Least Squares Mean
791922|NCT00887354|Secondary|Percentage of Participants Reporting Hip Pain in Modification of the Charnley's Pain Scale|Self-reported hip pain scale in which 0=no pain; 1=pain is slight or intermittent, pain on starting to walk but getting less with normal activity; 2=pain occurs only after some activity, disappears quickly with rest; 3=pain is tolerable, permitting limited activity; 4=pain is severe on attempting to walk, prevents all activity; 5=pain is severe and spontaneous.|Baseline|All randomized participants receiving at least one dose of study drug and having baseline Charnley's Pain Scale data.||percentage of participants|||Number
791923|NCT00887354|Secondary|Change From Baseline in Physical Component Summary of the Short Form-36 (SF-36) Questionnaire|SF-36 is a self-reported questionnaire consisting of 36 questions covering 8 health domains. Each domain was scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. The physical component summary (PCS) has been constructed based on the 8 SF-36 domains and consist of the physical functioning, bodily pain, role-physical, and general health scales (range = 0 to 100, with higher scores indicating better health status for functioning). Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for type of hip fracture (31-A1/31-A2) and adequate reduction (Yes/No).|Baseline, Week 6; Baseline, Week 12; Baseline, Week 18; Baseline, Week 26|All randomized participants receiving at least one dose of study drug and with at least one post-baseline efficacy measure.||units on a scale||Standard Error|Least Squares Mean
791924|NCT00887354|Secondary|Change in Areal Bone Mineral Density Measured at the Femoral Neck and Total Hip of the Non-Fractured Limb|"Femoral neck BMD: Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for baseline femoral neck BMD and type of hip fracture (31-A1/31-A2) .
Total hip BMD: Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for baseline total hip BMD, type of hip fracture (31-A1/31-A2) and duration of prior bisphosphonate use."|Baseline, Week 26; Baseline, Week 52; Baseline, Week 78|All randomized participants receiving at least one dose of study drug and with at least one post-baseline efficacy measure.||g/cm^2||Standard Error|Least Squares Mean
791925|NCT00887354|Secondary|Change in Lumbar Spine Areal Bone Mineral Density|Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for baseline lumbar spine BMD, type of hip fracture (31-A1/31-A2) and glucocorticoids used at baseline (Yes/No).|Baseline, Week 26; Baseline, Week 52|All randomized participants receiving at least one dose of study drug and with at least one post-baseline efficacy measure.||g/cm^2||Standard Error|Least Squares Mean
791926|NCT00887354|Primary|Change in Lumbar Spine Areal Bone Mineral Density (BMD)|Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for baseline lumbar spine BMD, type of hip fracture (31-A1/31-A2) and glucocorticoids used at baseline (Yes/No).|Baseline, Week 78|All randomized participants receiving at least one dose of study drug and with at least one post-baseline efficacy measure.||gram per square centimeter (g/cm^2)||Standard Error|Least Squares Mean
791946|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Comfort of Skin at Weeks 1 and 2|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Very Comfortable; 2, Comfortable; 3, Somewhat Comfortable; 4, Somewhat Uncomfortable; 5, Uncomfortable.|Weeks 1 and 2|ITT||Units on a scale||Standard Deviation|Mean
791929|NCT00887471|Secondary|Number of Patients With Apnea-hypopnea Index (AHI) Less Than or Equal to 5|Number of patients with postoperative apnea-hypopnea index (apneas plus hypopneas per hour of sleep) less than or equal to 5 on sleep study|Baseline and 4 years|||participants|||Number
791930|NCT00887471|Primary|Median Change in Apnea-hypopnea Index (AHI)|Change in the number of apneas plus hypopneas per hour of sleep on preoperative sleep study compared to postoperative sleep study, Change is calculated as baseline minus 4-year time point|Baseline and 4 years|||events per hour of sleep||Standard Deviation|Median
791931|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product at Week 8|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Very Satisfied; 2, Satisfied; 3, Neutral; 4, Unsatisfied; 5, Very Unsatisfied.|Week 8|ITT||Units on a scale||Standard Deviation|Mean
791932|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product at Weeks 1 and 2|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Very Satisfied; 2, Satisfied; 3, Neutral; 4, Unsatisfied; 5, Very Unsatisfied.|Weeks 1 and 2|ITT||Units on a scale||Standard Deviation|Mean
791933|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up at Week 8|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, Not Applicable; 1, Very Easy; 2, Easy; 3, Neutral; 4, Difficult; 5, Very Difficult.|Week 8|ITT||Units on a scale||Standard Deviation|Mean
791934|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Ease of Use Wtih Make-Up at Weeks 1 and 2|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, Not Applicable; 1, Very Easy; 2, Easy; 3, Neutral; 4, Difficult; 5, Very Difficult.|Weeks 1 and 2|ITT||Units on a scale||Standard Deviation|Mean
791935|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment at Week 8|Product Acceptability and Preference Questionnaire were completed by the subject at 8 week timepoint by answering Yes or No to the following question: If you were to choose to continue treatment for your acne, would you use the study product?|Week 8|ITT||Participants|||Number
791936|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment at Week 1 and 2|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint by answering Yes or No to the following question: If you were to choose to continue treatment for your acne, would you use the study product?|Weeks 1 and 2|ITT||Participants|||Number
791937|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin at Week 8|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint by answering Yes or No to the following question: Did you feel that your skin was hydrated and moisturized while you were on your study product?|Week 8|ITT||Participants|||Number
791938|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin at Weeks 1 and 2|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint by answering Yes or No to the following question: Did you feel that your skin was hydrated and moisturized while you were on your study product?|Weeks 1 and 2|ITT||Participants|||Number
791939|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Compliance at Week 8|Product Acceptability and Preference Questionnaire were completed by the subject at week 8 by answering Yes or No to the following question: Did you use the product every day?. When only one product was applied to the face, subjects were asked to rate their compliance by answering the aforementioned question, rather than rating compliance on a 0-2 scale.|Week 8|ITT||Participants|||Number
791940|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Compliance at Weeks 1 and 2|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, Not Compliant at all; 1, Mostly Compliant; 2, Very Compliant.|Weeks 1 and 2|ITT||Units on a scale||Standard Deviation|Mean
791941|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products at Week 8|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, Highly Favorable; 2, Favorable; 3, Neutral; 4, Unfavorable; 5, More Dissatisfied.|Week 8|ITT||Units on a scale||Standard Deviation|Mean
791942|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products at Weeks 1 and 2|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Highly Favorable; 2, Favorable; 3, Neutral; 4, Unfavorable; 5, Uncomfortable.|Weeks 1 and 2|ITT||Units on a scale||Standard Deviation|Mean
791943|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Comparison of Study Products Used in the Past at Week 8|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, More Satisfied; 2, Somewhat More Satisfied; 3, Neither Satisfied or Dissatisfied; 4, Somewhat More Dissatisfied; 5, More Dissatisfied.|Week 8|ITT||Units on a scale||Standard Deviation|Mean
791944|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Which Study Product is Subject More Satisfied With? at Weeks 1 and 2|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following choices: Epiduo, Clindoxyl Gel, Both Treatments Equally.|Weeks 1 and 2|ITT. Data are presented for only those participants completing the questionnaire.||Participants|||Number
791947|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Ease of Application of Product at Week 8|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, Very easy; 2, Easy; 3, Neutral; 4, Difficult.|Week 8|ITT||Units on a scale||Standard Deviation|Mean
791949|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Severity of Scaling at Week 8|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe; 5, Very Severe.|Week 8|ITT||Units on a scale||Standard Deviation|Mean
791950|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Severity of Scaling at Weeks 1 and 2|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe; 5, Very Severe.|Weeks 1 and 2|ITT||Units on a scale||Standard Deviation|Mean
791951|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Severity of Itching at Week 8|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe.|Week 8|ITT||Units on a scale||Standard Deviation|Mean
791952|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Severity of Itching at Weeks 1 and 2|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe.|Weeks 1 and 2|ITT||Units on a scale||Standard Deviation|Mean
791953|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Severity of Burning at Week 8|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe.|Week 8|ITT||Units on a scale||Standard Deviation|Mean
791954|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Severity of Burning at Weeks 1 and 2|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe.|Weeks 1 and 2|ITT||Units on a scale||Standard Deviation|Mean
791955|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Severity of Dryness at Week 8|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe.|Week 8|ITT||Units on a scale||Standard Deviation|Mean
791956|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Severity of Dryness at Weeks 1 and 2|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe.|Weeks 1 and 2|ITT||Units on a scale||Standard Deviation|Mean
791957|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Severity of Redness at Week 8|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe.|Week 8|ITT||Units on a scale||Standard Deviation|Mean
791958|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Severity of Redness at Weeks 1 and 2|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe.|Weeks 1 and 2|ITT||Units on a scale||Standard Deviation|Mean
791959|NCT00887484|Secondary|Quality of Life Questionnaire - Global Score|Skindex-29 is a self-administered (by participants at each time point) QoL questionnaire comprised of 29 items (it.) scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 it.); symptomatic (7 it.); functional (12 it.). Domain scores range from 0 to 40, 0 to 28, and 0 to 48, respectively. Lower scores=better QoL. A Global Score (range 0-100)=(sum of all 29 individual item scores) * 100/116.|Baseline, Weeks 2 and 8|ITT||Units on a scale||Standard Deviation|Mean
791960|NCT00887484|Secondary|Quality of Life Questionnaire - Functional Domain|Skindex-29 is a self-administered (by participants at each time point) QoL questionnaire comprised of 29 items (it.) scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 it.); symptomatic (7 it.); functional (12 it.). Domain scores range from 0 to 40, 0 to 28, and 0 to 48, respectively. Lower scores=better QoL. The functional score (score=0 to 48)=(sum of the 12 individual item scores) * 100/48.|Baseline, Weeks 2 and 8|ITT||Units on a scale||Standard Deviation|Mean
791961|NCT00887484|Secondary|Quality of Life Questionnaire - Emotional Domain|Skindex-29 is a self-administered (by participants at each time point) QoL questionnaire comprised of 29 items (it.) scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 it.); symptomatic (7 it.); functional (12 it.). Domain scores range from 0 to 40, 0 to 28, and 0 to 48, respectively. Lower scores=better QoL. The emotional score (score=0 to 40)=(sum of the 10 individual item scores) * 100/40.|Baseline, Weeks 2 and 8|ITT||Units on a scale||Standard Deviation|Mean
791962|NCT00887484|Secondary|Skindex-29 Quality of Life Questionnaire (QoL) - Symptomatic Domain|Skindex-29 is a self-administered (by participants at each time point) QoL questionnaire comprised of 29 items (it.) scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 it.); symptomatic (7 it.); functional (12 it.). Domain scores range from 0 to 40, 0 to 28, and 0 to 48, respectively. Lower scores=better QoL. The symptomatic score (score=0 to 28)=(sum of the 7 individual item scores) * 100/28.|Baseline, Weeks 2 and 8|ITT||Units on a scale||Standard Deviation|Mean
791963|NCT00887484|Secondary|Non-inflammatory Acne Lesion Counts|Total number of non-inflammatory acne lesions (whiteheads and blackheads) at each timepoint.|Baseline, Weeks 5 and 8|ITT||Acne Lesions||Standard Deviation|Mean
791964|NCT00887484|Secondary|Inflammatory Acne Lesion Counts|Total number of inflammatory acne lesions (pustules, papules) at each timepoint.|Baseline, Weeks 5 and 8|ITT||Acne Lesions||Standard Deviation|Mean
791965|NCT00887484|Secondary|Total Acne Lesion Counts|Total acne lesion counts - includes both inflammatory acne lesions (pustules, papules), noninflammatory lesions (whiteheads and blackheads),|Baseline, Weeks 5 and 8|ITT||Acne Lesions||Standard Deviation|Mean
791994|NCT00887588|Secondary|Change From Baseline in Albumin/Creatinine Ratio|Evaluation of albumin/creatinine was performed by central laboratory. A ratio < 1 indicates improvement.|baseline, 36 weeks|Participants from the extension efficacy set, who had both baseline and 36 week values, were included in the analysis for that parameter. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.||ratio||95% Confidence Interval|Geometric Mean
791966|NCT00887484|Secondary|Investigators Static Global Assessment|ISGA is evaluated using the following scale: 0, Clear: Clear skin with no lesions; 1, Almost Clear: Rare non-inflammatory lesions; 2, Mild: Some non-inflammatory lesions with no more than a few inflammatory lesions but no nodular lesions); 3, Moderate: Up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than 1 small nodular lesion; 4, Severe: Up to many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions; 5, Very Severe: Many non-inflammatory and inflammatory lesions and more than a few nodular lesions. May have cystic lesions.|Baseline, Weeks 5, 8|For the first 2 weeks, participants apply one of the drugs (Clindoxyl or Epiduo) to one side of the face and the other drug to the other side of their face. After week 2, participants apply Clindoxyl to their entire face and do not use Epiduo.||units on a scale||Standard Deviation|Mean
791967|NCT00887484|Secondary|Irritant/Allergic Contact Dermatitis|"Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face.
Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense."|Weeks 5 and 8|ITT||units on a scale||Standard Deviation|Mean
791968|NCT00887484|Secondary|Skin Peeling|"Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face.
Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense."|Weeks 5 and 8|ITT||units on a scale||Standard Deviation|Mean
791969|NCT00887484|Primary|Irritant/Allergic Contact Dermatitis|"Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face.
Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense."|Weeks 1 and 2|ITT||units on a scale||Standard Deviation|Mean
791970|NCT00887484|Primary|Skin Peeling|"Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face.
Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3,Intense."|Weeks 1 and 2|ITT||units on a scale||Standard Deviation|Mean
791971|NCT00887484|Primary|Skin Dryness|"Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face.
Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense."|Weeks 1 and 2|ITT||units on a scale||Standard Deviation|Mean
791972|NCT00887484|Secondary|Skin Dryness|"Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face.
Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense."|Weeks 5 and 8|ITT||units on a scale||Standard Deviation|Mean
791973|NCT00887484|Secondary|Erythema (Redness)|"Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face.
Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense."|Weeks 5 and 8|ITT||units on a scale||Standard Deviation|Mean
791974|NCT00887484|Primary|Erythema (Redness)|"Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face.
Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense."|Weeks 1 and 2|Intent-to-Treat (ITT)||units on a scale||Standard Deviation|Mean
791977|NCT00887549|Secondary|Percentage of Participants Surviving at 18 Months (Overall Survival Rate)|The percentage of participants surviving at 18 months was defined as the number of treated participants who had not died prior to 18 months from the date of their first dose divided by the total number of treated participants multiplied by 100. For participants who are alive, overall survival was censored at the last contact.|Baseline to date of death (up to 24.5 months)|All enrolled participants. Nineteen participants were censored for overall survival.||percentage of participants||95% Confidence Interval|Number
791978|NCT00887549|Secondary|Percentage of Participants With Concordance Between Local and Central Histological Diagnosis|A centralized pathology review on all enrolled participants was performed to confirm the histological diagnosis performed at the site. Upon review of the local diagnosis obtained at the respective site, the central reviewer established whether or not there was an agreement between the local and central diagnosis. The percentage of participants with concordance was defined as the number of participants for which there was an agreement divided by the number of treated participants (concordance rate) multiplied by 100.|Baseline|All enrolled participants.||percentage of participants||95% Confidence Interval|Number
791979|NCT00887549|Secondary|Percentage of Participants With Tumor Response (Tumor Response Rate)|Tumor response was assessed using Response Evaluation Criteria In Solid Tumors (RECIST 1.0) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. Percentage of participants with tumor response was determined by the number of participants with PR or CR (confirmed or not) divided by the total number of treated participants multiplied by 100.|Baseline to disease progression (up to 20 months)|All enrolled participants.||percentage of participants||95% Confidence Interval|Number
792042|NCT00888979|Secondary|Change in Number of Cigarettes Used Per Day From Baseline to 4 Weeks.||Baseline to 4 weeks|||reduction in number of CPD||Standard Deviation|Mean
792043|NCT00888979|Secondary|Cartridge Use||Baseline to 4 weeks|||cartridges per day||Standard Deviation|Mean
791980|NCT00887549|Primary|Progression Free Survival (PFS)|PFS is time from first dose to first observation of disease progression/death (any cause). PFS is reported for participants with thymidylate synthase (TS) scores. For participants not known to have died by the data cut-off date and who do not have progressive disease, PFS will be censored at date of last objective progression-free disease assessment. For participants who receive systemic anticancer therapy after study drug discontinuation and prior to disease progression/death, PFS will be censored at date of last objective progression-free disease assessment prior to chemotherapy.|Baseline to measured progressive disease with follow-up every 6 weeks until progression of disease (up to 18 months after the last participant commenced induction therapy)|Population for the efficacy assessment includes all treated participants with a valid TS expression assessment. Six participants were censored for PFS.||months||95% Confidence Interval|Median
791981|NCT00887562|Secondary|Mean Change in Score on the Fatigue Severity Scale (FSS)|"To assess changes following 1 month treatment with 2 different doses of idebenone with that of placebo in fatigue as assessed by the Fatigue Severity Scale (FSS).
Scale score minimum is 9 (least fatigue) and maximum is 63 (maximum fatigue). Scores of 36 or less indicate possibility that patient may not be suffering from fatigue, while scores 36 and over suggest suffering from fatigue"|Baseline and Week 4|||units on a scale||Standard Deviation|Mean
791982|NCT00887562|Secondary|Mean Change in Venous Lactate Concentration|To compare the efficacy of 1 month treatment with 2 different doses of idebenone with that of placebo on venous lactate concentration|Up to 4 weeks from baseline|||mM/L||Standard Deviation|Mean
791983|NCT00887562|Primary|Mean Change in Cerebral Lactate Concentration (as Measured by Magnetic Resonance Spectroscopy)|To compare the efficacy of 1 month treatment with 2 different doses of idebenone with that of placebo on cerebral lactate concentration as measured by magnetic resonance spectroscopy (MRS)|Up to 4 weeks from baseline|||IU||Standard Deviation|Mean
791984|NCT00887575|Secondary|Overall Survival (OS)|Defined as the time between Day 1 Cycle 1 to time of death from any cause.|24 months|||probability of overall survival at 24 m||95% Confidence Interval|Number
791985|NCT00887575|Secondary|Disease-free Survival|Defined as the time between day of surgery to first documented disease occurrence or death due to any cause.|every 4 weeks from date of surgery until treatment discontinuation or death, expected average 18 months|||months||90% Confidence Interval|Median
791986|NCT00887575|Secondary|Overall Response Rate (ORR)|Assessed by clinical, radiologic and surgical determinations before and after neoadjuvant therapy. Measurable lesions will be defined by RECIST criteria v1.1.|Days 1, 8 and 15 of each cycle, minimum of 12 weeks|Patients who were enrolled, treated at the MTD and completed at least 3 cycles of neoadjuvant therapy||participants|||Number
791987|NCT00887575|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Assessments will be made through analysis of reported incidence of treatment-emergent adverse events (AEs) and serious adverse events (SAEs) at the phase II dose|Days 1, 8, and 15 of each 4-week cycle up to 24 weeks during neoadjuvant treatment, and every 4 weeks during maintenance treatment|The safety analysis includes all eligible patients enrolled at the MTD, whether or not treatment was recieved (6 patients in Phase I were treated at the MTD, 39 patients were enrolled in Phase II, 3 were deemed ineligible after enrollment-thus 42 patients are included in the safety analysis, including 1 eligible patient who was not treated)||participants|||Number
791988|NCT00887575|Primary|Phase II: The Number of Subjects Exhibiting Pathologic Complete Response to Neoadjuvant Treatment With Sunitinib/Paclitaxel/Carboplatin|Pathologic complete response (PCR) is defined as no residual invasive breast cancer in final breast or axillary lymph node samples.|at weeks 26-30|Patients treated at Dose Level I (Phase I and Phase II) who underwent surgery||participants|||Number
791989|NCT00887588|Secondary|Change From Baseline in Sitting SBP, Sitting DBP and Sitting Pulse Pressure (PP)|Sitting blood pressure and sitting pulse pressure were assessed. A negative change from baseline indicates improvement.|baseline, 36 weeks|Extension efficacy set: The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.||mmHg||Standard Error|Least Squares Mean
791990|NCT00887588|Secondary|Change From Baseline in Arterial Stiffness Parameters: Pulse Wave Velocity|A vascular arterial stiffness sub-study was conducted in a subset of participants. Noninvasive arterial tonometry was assessed using the Sphygmor device. Participants had arterial stiffness, pulse wave velocity and central pressures measured. A negative change from baseline indicates improvement.|baseline, 36 weeks|Participants from the arterial stiffness set, who had values for both baseline and week 36, were analyzed. The arterial stiffness set included randomized participants who participated in the arterial stiffness sub-study.||cm/s||Standard Error|Least Squares Mean
791991|NCT00887588|Secondary|Change From Baseline in Arterial Stiffness Parameters: Heart Rate|A vascular arterial stiffness sub-study was conducted in a subset of participants. Noninvasive arterial tonometry was assessed using the Sphygmor device. Participants had arterial stiffness, pulse wave velocity and central pressures measured. A negative change from baseline indicates improvement.|baseline, 36 weeks|Participants from the arterial stiffness set, who had values for both baseline and week 36, were analyzed. The arterial stiffness set included randomized participants who participated in the arterial stiffness sub-study.||bpm||Standard Error|Least Squares Mean
791992|NCT00887588|Secondary|Change From Baseline in Arterial Stiffness Parameters: Heart Rate Correct Cen Aug/Pulse Ht|A vascular arterial stiffness sub-study was conducted in a subset of participants. Noninvasive arterial tonometry was assessed using the Sphygmor device. Participants had arterial stiffness, pulse wave velocity and central pressures measured. A negative change from baseline indicates improvement.|baseline, 36 weeks|Participants from the arterial stiffness set, who had values for both baseline and week 36, were analyzed. The arterial stiffness set included randomized participants who participated in the arterial stiffness sub-study.||Percent||Standard Error|Least Squares Mean
791993|NCT00887588|Secondary|Change From Baseline in Arterial Stiffness Parameters: Brachial Systolic Blood Pressure (SBP), Brachial Diastolic Blood Pressure (DBP), Central Augmentation Pressure, Central Pressure at T1-DP, Central SBP, Central DBP, Central Mean Pressure|A vascular arterial stiffness sub-study was conducted in a subset of participants. Noninvasive arterial tonometry was assessed using the Sphygmor device. Participants had arterial stiffness, pulse wave velocity and central pressures measured. A negative change from baseline indicates improvement.|baseline, 36 weeks|Participants from the arterial stiffness set, who had values for both baseline and week 36, were analyzed. The arterial stiffness set included randomized participants who participated in the arterial stiffness sub-study.||mmHg||Standard Error|Least Squares Mean
791995|NCT00887588|Secondary|Change From Baseline in Serum Creatinine|Evaluation of serum creatinine was performed by central laboratory. A negative change from baseline indicates improvement.|baseline, 36 weeks|Extension efficacy set: the extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.||µmol/L||Standard Error|Least Squares Mean
791996|NCT00887588|Secondary|Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)|eGFR was calculated from the serum creatinine concentration determined by central laboratory assessment. A positive change from baseline indicates improvement.|baseline, 36 weeks|Participants from the extension efficacy set, who had both baseline and 36 week values, were included in the analysis for that parameter. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.||mL/min/1.73m^2||Standard Error|Least Squares Mean
791997|NCT00887588|Secondary|Percentage of Participants With New York Heart Association (NYHA) Class I, II, II or IV|The NYHA Functional Classification classifies patients' heart failure according to the severity of their symptoms. The classification is as follows: Class I: no limitation of physical activity, ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea (shortness of breath); Class II: slight limitation to physical activity, comfortable at rest, ordinary physical activity results in fatigue, palpitation or dyspnea; Class III: marked limitation of physical activity, comfortable at rest, less than ordinary activity causes fatigue, palpitation or dyspnea; Class IV: unable to carry on any physical activity without discomfort, symptoms of heart failure at rest, if any physical activity is undertaken, discomfort increases.|baseline, 36 weeks|Extension efficacy set: the extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.||Percentage of participants|||Number
791998|NCT00887588|Secondary|Percentage of Participants With Clinical Composite Assessment of Improved, Unchanged or Worsened|The clinical composite assessment is defined as follows: Improved = a) participant improved (markedly or moderately) in the global assessment of disease activity with no worsening of NYHA functional class and no major adverse cardiovascular event or b) participant improved in NYHA functional class with no worsening (markedly or moderately) in the global assessment of disease activity and no major adverse cardiovascular event. Worsened = participant worsened (markedly or moderately) in the global assessment of disease activity or in NYHA functional class or experienced a major adverse cardiovascular event. Unchanged = participant does not meet the definition for improved or worsened.|36 weeks|Extension efficacy set: the extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.||Percentage of participants|||Number
791999|NCT00887588|Secondary|Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score and Individual Domain Summary Scores|The KCCQ is a self-administered questionnaire. It contains 23 items, covering physical function, clinical symptoms, social function, self-efficacy and knowledge, and quality of life, each with different Likert scale wording, including limitations, frequency, bother, change in condition, understanding, levels of enjoyment and satisfaction. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. A positive change from baseline indicates improvement.|baseline, 36 weeks|Participants from the extension efficacy set, who had both baseline and 36 week values for each domain, were included in the analysis for that domain. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.||score on a scale||Standard Error|Least Squares Mean
792000|NCT00887588|Secondary|Change From Baseline in Echocardiography Parameters: Tricuspid Regurgitation Velocity|A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement.|Baseline, 36 weeks|Participants from the extension efficacy set, who had both baseline and 36 week values, were included in the analysis. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.||m/s||Standard Error|Least Squares Mean
792001|NCT00887588|Secondary|Change in Echocardiography Parameters: Isovolumic Relaxation Time|A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement.|Baseline, 36 weeks|Participants from the extension efficacy set, who had both baseline and 36 week values, were included in the analysis. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.||ms||Standard Error|Least Squares Mean
792002|NCT00887588|Secondary|Change From Baseline in Echocardiography Parameters: Ratio of E to A Velocity, E/e' Ratio|A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A ratio < 1 indicates improvement.|Baseline, 36 weeks|Participants from the extension efficacy set, who had both baseline and 36 week values for each parameter, were included in the analysis for that parameter. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.||ratio||Standard Error|Least Squares Mean
792003|NCT00887588|Secondary|Change From Baseline in Echocardiography Parameters: Ewave Velocity, A Wave Velocity, e' at Septal Mitral Annulus, e' at Lateral Mitral Annulus|A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement.|Baseline, 36 weeks|Participants from the extension efficacy set, who had both baseline and 36 week values for each parameter, were included in the analysis for that parameter. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.||cm/s||Standard Error|Least Squares Mean
792004|NCT00887588|Secondary|Change From Baseline in Echocardiography Parameters: Left Atrial Volume Index|A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement.|Baseline, 36 weeks|Participants from the extension efficacy set, who had both baseline and 36 week values, were included in the analysis. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.||ml/m^2||Standard Error|Least Squares Mean
792044|NCT00888979|Primary|Number of Days of Inhaler Use||Baseline to 4 weeks|||days||Standard Deviation|Mean
792005|NCT00887588|Secondary|Change From Baseline in Echocardiography Parameters: Left Ventricular Mass Index|A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement.|Baseline, 36 weeks|Participants from the extension efficacy set, who had both baseline and 36 week values, were included in the analysis. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.||g/m^2||Standard Error|Least Squares Mean
792006|NCT00887588|Secondary|Change From Baseline in Echocardiography Parameters: Left Ventricular Mass|A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement.|Baseline, 36 weeks|Participants from the extension efficacy set, who had both baseline and 36 week values, were included in the analysis. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.||grams (g)||Standard Error|Least Squares Mean
792007|NCT00887588|Secondary|Change From Baseline in Echocardiography Parameters: Left Ventricular Ejection Fraction|A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement.|Baseline, 36 weeks|Participants from the extension efficacy set, who had both baseline and 36 week values, were included in the analysis. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.||Percent ejection fraction||Standard Error|Least Squares Mean
792008|NCT00887588|Secondary|Change From Baseline in Echocardiography Parameters: LVE Diastolic Volume, LVE Systolic Volume, Left Ventricular Stroke Volume, Left Atrial Volume|A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement.|Baseline, 36 weeks|Participants from the extension efficacy set, who had both baseline and 36 week values for each parameter, were included in the analysis for that parameter. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.||ml||Standard Error|Least Squares Mean
792009|NCT00887588|Secondary|Change From Baseline in Echocardiography (ECHO) Parameters: Left Ventricular End (LVE) Diastolic Diameter, LVE Systolic Diameter, Septal End Diastolic Thickness, Posterior LV Wall End Diastolic Thickness, Relative Wall Thickness, Left Atrial Dimension|A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement.|Baseline, 36 weeks|Participants from the extension efficacy set, who had both baseline and 36 week values for each parameter, were included in the analysis for that parameter. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.||cm||Standard Error|Least Squares Mean
792010|NCT00887588|Secondary|Change From Baseline in Plasma Cyclic Guanine Monophosphate (cGMP)|Evaluation of cGMP was performed by a central laboratory. Change from baseline in cGMP was presented as a ratio where the ratio was calculated as the cGMP value at 36 weeks over the cGMP value at baseline. A ratio < 1 indicates improvement.|baseline, 36 weeks|Participants from the extension efficacy set, who had both baseline and 36 week values, were included in the analysis for that parameter. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.||ratio: endpoint/baseline (nmol/L)||95% Confidence Interval|Geometric Mean
792011|NCT00887588|Secondary|Change From Baseline in NT-proBNP and Brain Natriuretic Peptide (BNP)|Evaluation of NT-proBNP and BNP was performed by a central laboratory. Change from baseline in NT-proBNP and in BNP was presented as a ratio where the ratio for NT-proBNP was calculated as the NT-proBNP value at 36 weeks over the NT-proBNP value at baseline, and the ratio for BNP was calculated as the BNP value at 36 weeks over the BNP value at baseline. A ratio < 1 indicates improvement.|baseline, 36 weeks|Participants from the extension efficacy set, who had both baseline and 36 week values for each parameter, were included in the analysis for that parameter. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.||ratio: endpoint/baseline (pg/mL)||95% Confidence Interval|Geometric Mean
792012|NCT00887588|Primary|Change From Baseline in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)|Evaluation of NT-proBNP was performed by a central laboratory. Change from baseline in NT-proBNP was presented as a ratio where the ratio was calculated as the NT-proBNP value at 12 weeks over the NT-proBNP value at baseline. A ratio < 1 indicates improvement.|Baseline, 12 weeks|Participants from the full analysis set (FAS), who had both baseline and 12 week values, were included in the analysis. The FAS consisted of all randomized participants who had baseline and at least one post-baseline efficacy measurement during the double blind period.||ratio: endpoint/baseline (pg/mL)||95% Confidence Interval|Geometric Mean
792013|NCT00887640|Secondary|Safety and Tolerability of Temsirolimus|Total number of grade 3, 4, and 5 adverse events at least possibly related to temsirolimus therapy. Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and were converted to 4.0 for the purposes of reporting to ClinicalTrials.gov.|2 years|||Adverse Events|||Number
792014|NCT00887640|Secondary|Change Over Time in CTC Gene Expression Profile|Percent change in CTC gene expression from baseline to 8 or 12 weeks of treatment.|12 weeks|Data were insufficient to evaluate this outcome. Data not collected. This outcome was not performed due to availability and feasibility of the tests involved.|||||
792015|NCT00887640|Secondary|Time to Second PSA Progression After Addition of Anti-androgen Therapy|Time in months from the time of anti-androgen therapy to the date of second PSA progression . Patients alive who had not progressed as of the last follow-up or patients who had expired had time to second PSA progression censored at the last follow-up date or death date. The median was estimated using a Kaplan-Meier curve.|2 years|Data were insufficient to evaluate this outcome. Data not collected. Patients progressed radiographically before 2nd PSA progression occurred.|||||
792016|NCT00887640|Secondary|Time to PSA Progression|Time in months from the start of study treatment to the date of first PSA progression . Patients alive who had not progressed as of the last follow-up or patients who had expired had time to PSA progression censored at the last follow-up date or death date. The median was estimated using a Kaplan-Meier curve.|2 years|Data were insufficient to evaluate this outcome. Data not collected. PSA responses were not observed in this study and PSA progression dates would essentially be the same as the radiographic PFS dates.|||||
792017|NCT00887640|Secondary|Maximum Rate of Change of Prostate-Specific Antigen (PSA).|Percent change in PSA between baseline and the measurement time point where the largest change in PSA occurred. Note that a positive change (greater than 0) indicates an increase in PSA, and a negative change (less than 0) indicates a decrease.|Baseline to 7 months|||Percent change||Full Range|Median
792018|NCT00887640|Secondary|Median Progression-Free Survival (PFS)|Time in months from the start of study treatment to the date of first progression according to Prostate Cancer Clinical Trial Working Group 2 (PCWG2) criteria, or to death due to any cause. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Additionally, according to PCWG2 criteria, disease progression in bone is defined as 2 or more new lesions seen on bone scan compared with the baseline scan used for trial entry. Per PCWG2 guidelines, therapy was not discontinued solely due to a rise in PSA alone.|2 years|||Months||95% Confidence Interval|Median
792019|NCT00887640|Secondary|Percent Change in LDH|To evaluate and correlate changes in serum Lactate Dehydrogenase (LDH) with CTC count changes over time in men with Castrate Resistant Prostate Cancer (CRPC) treated with temsirolimus|Baseline to 12 weeks|Data were insufficient to evaluate this outcome. Data not collected. This outcome was not performed due to availability and feasibility of the tests involved.|||||
792020|NCT00887640|Secondary|Mean Percent of N-cadherin Expression at Baseline and 8 Weeks of Treatment.|Measures of epithelial plasticity on CTCs in response to Mammalian Target of Rapamycin (mTOR) inhibition with temsirolimus, using genomic and protein immunohistochemical methodology. N-cadherin was measured in CTCs captured using the CellSearch profile kit. The proportion of CTCs expressing N-cadherin was calculated and divided by the total number of CD45-negative, pan cytokeratin (CK) – positive, and 4’,6-diamidino-2-phenylindole (DAPI+) intact cells to give a fractional expression of N-cadherin. Results are reported as a percentage.|Baseline and 8 weeks|N-cadherin expression at both baseline and 8 weeks was evaluable in 7 patients.||Percent expression||Full Range|Median
792021|NCT00887640|Secondary|Percent Change in CTC Count From Baseline to 12 Weeks of Treatment.|To evaluate the change in CTC counts upon the addition of an anti-androgen upon PSA progression while on temsirolimus therapy|Baseline to 12 weeks|Data were insufficient to evaluate this outcome. Outcome not available at 12 weeks. CTCs were not collected at week 12 and thus were not analyzed.|||||
792022|NCT00887640|Primary|Change in Circulating Tumor Cell (CTC) Counts in Men With Metastatic Treatment-refractory Castration-resistant Prostate Cancer.|Median percent change in CTC count from baseline to 8 weeks of treatment. Percent change was calculated by determining the percentage increase or decrease in CTC count from baseline.|Baseline to 8 weeks|CTC count at both baseline and week 8 were assessable in 8 of the 11 patients as CTCs were collected at both time points in these patients. Missing CTC data for 3 of the 11 patients due to laboratory error or no CTC available at various time points.||percent change||Inter-Quartile Range|Median
792023|NCT00887653|Primary|Change From Baseline Triglycerides|Assess changes from baseline triglycerides at 6 months|6 months|||units on a scale||Full Range|Median
792024|NCT00887653|Secondary|Proportion of Patients With Plasma Viral Load Below the Limit of Detection|Assess proportion of patients with PVL below limit of detection at end of study.|6 months|One subject was prematurely discontinued from the study at week 12 due to detectable HIV-1 RNA of 57 copies/mL that was sustained at 61 copies on repeated measurement two weeks later.||proportion of participants|||Number
792025|NCT00887653|Primary|Change From Baseline Triglycerides|Assess changes from baseline triglycerides at 3 months|3 months|||units on a scale||Full Range|Median
792034|NCT00888654|Secondary|Levels of Androgen Receptor, NF-kB, and PSA in Prostate Tissue||Pre and post radical prostatectomy||||||
792035|NCT00888654|Secondary|Serum Levels of PSA, Testosterone,DIM Level and Diindolylmethane||Pre and post radical prostatectomy||||||
792036|NCT00888654|Primary|Mean Level of Diindolylmethane in Prostate Tissue After Treatment||Within the first 24 months after radical prostatectomy.|Patients that were eligible, evaluable, and compliant||ng/g||90% Confidence Interval|Mean
792037|NCT00888849|Primary|Return to Bowel Activity||Number of days post-surgery to appearance of peristaltic movement|||days||Standard Error|Mean
792038|NCT00888849|Primary|Time of Anastomosis||Total time (minutes) from placement of stay suture to final anastomotic staple (Group II) or final anastomotic suture (Group I)|||minutes||Standard Error|Mean
792039|NCT00888849|Primary|Time of Surgery (Skin Open to Skin Close)||Day 1|Intent-to-Treat||minutes||Standard Error|Mean
792040|NCT00888940|Secondary|Treatment-emergent Adverse Events.||Over the duration of the study.|Safety population analyzed||events|||Number
792041|NCT00888940|Primary|Cumulative Volume of Packed Red Blood Cells Transfused||12 hours after the end of surgery|Modified Intent to Treat = all subjects received at least one dose and analyzed according to planned treatment assignment. 3 subjects in ecallantide group not included due to no value being present||mL||Standard Deviation|Mean
792045|NCT00889187|Secondary|Surgical Mortality Rate|The proportion of patients with a death related to the surgery (CTCAEv3 attribution possible, probable, definite).|Assessed up to 30 days after resection; Patients underwent resection of their pancreatic cancer up to 3 weeks after completion of chemoradiation therapy||09/2017||||
792046|NCT00889187|Secondary|Surgical Morbidity Rate|The proportion of patients experienced any grade 3-4 adverse event based on CTCAEv3 related to the surgery (attribution possible, probable, definite) as reported on case report forms.|Assessed after resection; Patients underwent resection of their pancreatic cancer up to 3 weeks after completion of chemoradiation therapy||09/2017||||
792047|NCT00889187|Secondary|Progression-Free Survival (PFS)|Progression-free survival based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) or death. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions. Patients alive whose disease had not progressed are censored at date of last disease evaluation|Disease was assessed radiologically at baseline and after treatment every 6 months for first 2 years and annually in years 3-5.||09/2017||||
792048|NCT00889187|Secondary|Pathologic Response Rate|Pathologic response rate is the proportion of patients with the pathologic specimen absent any viable tumor cell. Pathological review of the pancreaticoduodenectomy specimen will be performed according to the AJCC Staging Classification, 6th edition. Initial gross evaluation and identification of resection margins will be performed jointly by the surgeon and the pathologist.|Assessed after resection; Patients underwent resection of their pancreatic cancer up to 3 weeks after completion of chemoradiation therapy||09/2017||||
792049|NCT00889187|Secondary|Local Recurrence Rate|Local recurrence rate is defined as the proportion of patients with evidence of tumor recurrence within the radiation field based on RECIST criteria. Per RECIST 1.0 for target lesions, PD is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or appearance of new lesions. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|Disease was assessed radiologically at baseline and after treatment every 6 months for first 2 years and annually in years 3-5.||09/2017||||
792050|NCT00889187|Primary|Grade 3-5 Toxicity Rate [Phase II]|All Grade 3-5 events based on CTCAEv3 related to the accelerated dose (attribution possible, probable, definite) as reported on case report forms.|within 3 weeks of the start of chemoradiation therapy|The study did not proceed to phase II due to unexpected intraoperative complications experienced by patients enrolled on phase I.|||||
792051|NCT00889187|Primary|Dose Limiting Toxicity (DLT) [Phase I]|DLT occurring within 3 weeks of the start of chemoradiation therapy was defined as: Grade 3 non-hematologic or hematologic toxicity requiring interruption of >7 days (d) of chemo or >3d chemoradiation; Grade 4 non-hematologic; Grade 4 neutropenia or thrombocytopenia; Treatment-related death; Delays in surgery >3 weeks due to treatment-related toxicity. A 30% increase in any surgical complication rate beyond those previously established rates (readmission rate: 16%; pancreatic fistula/intra-abdominal abscess/infection rate: 27%, major intra-abdominal bleeding requiring return to OR: 1.6%, delayed gastric emptying: 4.4%, and superficial wound infection rate: 8%) was also considered a DLT.|within 3 weeks of the start of chemoradiation therapy|The analysis dataset is comprised of all treated patients.||patients with DLT|||Number
792052|NCT00889187|Primary|Neoadjuvant Short-Course Photon Radiation Therapy Maximum Tolerated Dose (MTD) [Phase I]|Neoadjuvant short-course photon radiation therapy MTD in combination with capecitabine 825 mg/m2 orally BID for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy is determined by the number of patients who experience a dose limiting toxicity (DLT). See subsequent primary outcome measure for the DLT definition. The MTD is defined as the highest dose at which fewer than one-third of patients experience a DLT. If none of 3 initial patients or only 1 of 6 patients have a DLT on dose level 3 then 6 additional patients are treated at this dose. If during this expansion, the rate of DLT exceeds 30% then the next lower dose level is declared the MTD. If no DLTs are observed, the MTD is not reached.|within 3 weeks of the start of chemoradiation therapy|The analysis dataset is comprised of all treated patients.||Gy per fraction|||Number
792053|NCT00889200|Primary|Cortisol Response to the Dex/CRH Test Post-treatment (6 Weeks Oral Drug)|Cortisol reponse to the DEX/CRH test post-treatment is the same as measured and calculated at baseline =delta(CORT).|post drug (6 weeks oral eszopiclone)|All subjects completed all study procedures||nmol/L|paired t-test cortisol reactivity|Standard Deviation|Mean
792054|NCT00889252|Primary|Visual Acuity Assessment|Visual acuity was assessed by the investigator using a Snellen visual acuity chart. This outcome counts the number of eyes that had vision of 20/40 or better at the 12 week visit.|at the 12 week visit|Subjects that completed the study per protocol were included in this analysis.||Eyes|Participants||Number
792055|NCT00889252|Primary|Dilated Ophthalmoscopy - Vitreous, Change From Baseline|Assessment of changes in the vitreous (gel-like fulid of the eye), using the scale: 0=none, 0.5=trace, 1=mild, 2=moderate, 3=severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.||Units on a scale|Participants|Standard Deviation|Mean
792056|NCT00889252|Primary|Dilated Ophthalmoscopy - Fundus, Change From Baseline|Assessment of changes in abnormalities on the back part of the eye, using the scale: 0=none, 0.5=trace, 1=mild, 2=moderate, 3=severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.||Units on a scale|Participants|Standard Deviation|Mean
792057|NCT00889252|Primary|Intraocular Pressure - Change From Baseline||baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.||mm of mercury|Participants|Standard Deviation|Mean
792058|NCT00889252|Primary|Corneal Staining - Central, Change From Baseline|Assessment of changes to the surface of the cornea, the central region, as evaluated by the degree of staining with sodium fluorescein solution, using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.||Units on a scale|Participants|Standard Deviation|Mean
792078|NCT00889330|Other Pre-specified|Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 0 Pre-dose, Pre-allergen Challenge|The number of eyes with any change in the following: anterior chamber, conjunctiva, cornea, iris, lens, lids, tear meniscus|Visit 3 (Day 0) pre-dose, pre-allergen challenge|||eyes|Participants||Number
792059|NCT00889252|Primary|Corneal Staining - Superior, Change From Baseline|Assessment of changes to the surface of the cornea, the upper region, as evaluated by the degree of staining with sodium fluorescein solution, using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.||Units on a scale|Participants|Standard Deviation|Mean
792060|NCT00889252|Primary|Corneal Staining - Inferior, Change From Baseline|Assessment of changes to the surface of the cornea, the bottom region, as evaluated by the degree of staining with sodium fluorescein solution, using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.||Units on a scale|Participants|Standard Deviation|Mean
792061|NCT00889252|Primary|Corneal Staining - Temporal, Change From Baseline|Assessment of changes to the surface of the cornea, the region towards the edge of the face, as evaluated by the degree of staining with sodium fluorescein solution, using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.||Units on a scale|Participants|Standard Deviation|Mean
792062|NCT00889252|Primary|Corneal Staining - Nasal, Change From Baseline|Assessment of changes to the surface of the cornea, the region towards the nose, as evaluated by the degree of staining with sodium fluorescein solution, using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.||Units on a scale|Participants|Standard Deviation|Mean
792063|NCT00889252|Primary|Cells in Anterior Chamber, Change From Baseline|Assessment of visible cells in the anterior chamber using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.||Units on a scale|Participants|Standard Deviation|Mean
792064|NCT00889252|Primary|Flare in Anterior Chamber, Change From Baseline|Assessment of visible protein in the anterior chamber using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.||Units on a scale|Participants|Standard Deviation|Mean
792065|NCT00889252|Primary|Lens Pathology, Change From Baseline|Assessment of the clarity of the intraocular lens using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.||Units on a scale|Participants|Standard Deviation|Mean
792066|NCT00889252|Primary|Corneal Endothelial, Change From Baseline|Assessment of the posterior cornea using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.||Units on a scale|Participants|Standard Deviation|Mean
792067|NCT00889252|Primary|Corneal Erosion, Change From Baseline|Assessment of corneal erosion using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.||Units on a scale|Participants|Standard Deviation|Mean
792068|NCT00889252|Primary|Corneal Edema, Change From Baseline|Assessment of corneal swelling using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.||Units on a scale|Participants|Standard Deviation|Mean
792069|NCT00889252|Primary|Conjunctival Chemosis, Change From Baseline|Assessment of swelling of the conjunctiva using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.||Units on a scale|Participants|Standard Deviation|Mean
792070|NCT00889252|Primary|Conjunctival Redness, Change From Baseline|Assessment of conjunctival redness using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.||Units on a scale|Participants|Standard Deviation|Mean
792071|NCT00889252|Primary|Lid and Lid Margin Swelling, Change From Baseline|Assessment of lid swelling using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.||Units on a scale|Participants|Standard Deviation|Mean
792072|NCT00889252|Primary|Lid and Lid Margin Erythema, Change From Baseline|Assessment of lid redness using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.||Units on a scale|Participants|Standard Deviation|Mean
792073|NCT00889265|Secondary|Mean Wound Healing Index at 6 Months|"Score Description
Uneventful wound healing with no gingival edema, erythema, suppuration, patient discomfort or flap dehiscence
Uneventful wound healing with slight gingival edema, erythema, patient discomfort or flap dehiscence but no suppuration
Poor wound healing with significant gingival edema, erythema, patient discomfort or flap dehiscence with suppuration"|6 months|||units on a scale||Standard Deviation|Mean
792074|NCT00889265|Primary|Change in Horizontal Ridge Widths From Baseline to 6 Months|The primary outcome measure of the study was the average change in ridge width from baseline (pre operative/pre grafting) to 6 months post surgery. The ridge measurements were taken using ridge mapping calipers and recorded for each patient at baseline and 6 months. Baseline measurements were taken at the site of greatest ridge width deficiency as determined by the investigator and repeated at the same location for subsequent measurements. A radiographic template with a radiopaque foil was utilized to standardize clinical and radiographic measurements for each patient.|6 months|||mm||Standard Deviation|Mean
792075|NCT00889330|Other Pre-specified|Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 14 Post-dose, Pre-allergen Challenge|The number of eyes with any change in the following: anterior chamber, conjunctiva, cornea, iris, lens, lids, tear meniscus|Visit 4 (Day 14) post-dose, pre-allergen challenge|||eyes|Participants||Number
792076|NCT00889330|Other Pre-specified|Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 14 Pre-dose, Pre-allergen Challenge|The number of eyes with any change in the following: anterior chamber, conjunctiva, cornea, iris, lens, lids, tear meniscus|Visit 4 (Day 14) pre-dose, pre-allergen challenge|||eyes|Participants||Number
792077|NCT00889330|Other Pre-specified|Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 0 Post-dose, Pre-allergen Challenge|The number of eyes with any change in the following: anterior chamber, conjunctiva, cornea, iris, lens, lids, tear meniscus|Visit 3 (Day 0) post-dose, pre-allergen challenge|||eyes|Participants||Number
792079|NCT00889330|Other Pre-specified|Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day -14|The number of eyes with any change in the following: anterior chamber, conjunctiva, cornea, iris, lens, lids, tear meniscus|Visit 2 (Day -14) pre-allergen challenge|||eyes|Participants||Number
792080|NCT00889330|Other Pre-specified|Number of Eyes With a Undilated Fundoscopy Changes From Visit 1 (Day -21) at Day 14|The number of eyes with any change to the following: Vitreous, Retina, Macula, Choroid, Optic Nerve|Visit 4 (Day 14) pre-dose, pre-allergen challenge|||eyes|Participants||Number
792081|NCT00889330|Other Pre-specified|Number of Eyes With a Visual Acuity Change From Visit 1 (Day -21) at Day 14 Pre-dose, Pre-allergen Challenge|The number of eyes with any change in visual acuity measurements compared to Day -21|Visit 4 (Day 14) pre-dose, pre-allergen challenge|||eyes|Participants||Number
792082|NCT00889330|Other Pre-specified|Number of Eyes With a Visual Acuity Change From Visit 1 (Day -21) at Day 0 Pre-dose, Pre-allergen Challenge|The number of eyes with any change in visual acuity measurements compared to Day -21|Visit 3 (Day 0) pre-dose, pre-allergen challenge|||eyes|Participants||Number
792083|NCT00889330|Other Pre-specified|Number of Eyes With a Visual Acuity Change From Visit 1 (Day -21) at Day -14|The number of eyes with any change in visual acuity measurements compared to Day -21.|Visit 2 (Day -14) pre-allergen challenge|||eyes|Participants||Number
792084|NCT00889330|Primary|Conjunctival Redness at Visit 4 (Day 14) at 20 Minutes Following Allergen Challenge, 15 Minutes Post Treatment Instillation|"A 0 to 4 scale used, allowing for half increment scores to measure redness, where 0 indicates none and 4 indicates extremely red; measurement taken at 20 minutes following allergen challenge, 16 hours post treatment instillation."|Visit 4 (Day 14) At 20 minutes following Allergen Challenge|||units on a scale||Standard Deviation|Mean
792085|NCT00889330|Primary|Ocular Itching at Visit 4 (Day 14) at 7 Minutes Following Allergen Challenge, 15 Minutes Post- Treatment Instillation|"0 to 4 scale, allowing for half increment scores, where 0 indicates none and 4 indicates incapacitating itch with an irresistible urge to rub"|Visit 4 (Day 14) up to 7 minutes following Allergen Challenge|||units on a scale||Standard Deviation|Mean
792086|NCT00889330|Primary|Conjunctival Redness at Visit 3 (Day 0) at 20 Minutes Following Allergen Challenge, 16 Hours After Treatment Instillation|"A 0 to 4 scale used, allowing for half increment scores to measure redness, where 0 indicates none and 4 indicates extremely red; measurement taken at 20 minutes following allergen challenge, 16 hours post treatment instillation."|Visit 3 (Day 0) At 20 minutes following Allergen Challenge, 16 hours post-treatment|||units on a scale||Standard Deviation|Mean
792087|NCT00889330|Primary|Ocular Itching at Visit 3 (Day 0) at 7 Minutes Following Allergen Challenge, 16 Hours After Treatment Instillation.|"A 0 to 4 scale used, allowing for half increment scores, where 0 indicates none and 4 indicates incapacitating itch with an irresistible urge to rub; measurement taken at up to 7 minutes following allergen challenge, 16 hours post treatment instillation."|Visit 3 (Day 0) 16 hours post-dose, at up to 7 minutes following Allergen Challenge|||units on a scale||Standard Deviation|Mean
792088|NCT00889421|Secondary|Type, Frequency, Severity, and Relationship of Adverse Events to Study Treatment||7 months||||||
792089|NCT00889421|Primary|Reduction in Cystoid Macular Edema||6 months||||||
792090|NCT00889421|Primary|Control of Ocular Inflammation, as Judged on Clinical Criteria, According to Standard Methods (Reduction of Anterior Chamber Cellular Activity and/or Chorioretinal Infiltrates and/or Retinal Vasculitis)||6 months||||||
792091|NCT00889421|Primary|Reduction in Dose of Systemic Corticosteroid or Other Immunosuppressive Therapy by at Least 50%||6 months||||||
792092|NCT00889421|Primary|Improvement by 2 or More Lines of Best-corrected Snellen Visual Acuity in at Least One Eye||6 months||||||
792093|NCT00889512|Secondary|Secondary Outcomes Include Pregnancy Rates, Number of Follicles, Hormone Levels on the Day of hCG, Days of GnRH Antagonist, Fertilization and Implantation Rates.||3 years||||||
792094|NCT00889512|Primary|The Primary Outcome Will be Number of Large Follicles (16 mm or Greater in Diameter) and Midsize Follicles (Greater Than 12mm But Less Than 16mm) in Both Groups on the Day of Meeting Size Criteria for hCG.||2 years|||number of follicles||Full Range|Median
792095|NCT00889603|Other Pre-specified|Number of Participants Receiving Other Medications|Information collected and recorded by investigator in accordance with existing medical records. World Health Organization- Drug (WHO-Drug) coding dictionary applied.|Baseline and Week 24|Safety population||Participants|||Number
792096|NCT00889603|Other Pre-specified|Number of Participants With Treatment Tolerability|Overall Evaluation of Tolerability at Week 24; 1=Very good, 2=Good, 3=Moderate, 4=Poor|Week 24|Safety population; N=number of particpants with evaluable data.||Participants|||Number
792097|NCT00889603|Secondary|Number of Participants in Each Patient Domain of Benefit|Participants asked to indicate if the cognition, functionality, and/or behavior domain were most benefited/improved after treatment (dichotomous yes/no endpoints where checking the CRF box next to each domain indicated ‘yes’ and leaving a box blank indicated ‘no’).|Week 24|Safety population: all participants who received at least 1 dose of study drug. N=number of participants with evaluable data. Week 24 LOCF not reported as data only collected at Week 24.||Participants|||Number
792098|NCT00889603|Secondary|Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 24 LOCF|CGI-I: 7-point Investigator-rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Week 24|FAS; LOCF. N=number of participants with evaluable data.||Participants|||Number
792099|NCT00889603|Secondary|Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 24|CGI-I: 7-point Investigator-rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Week 24|FAS. N=number of participants with evaluable data.||Participants|||Number
792100|NCT00889603|Secondary|Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 16|CGI-I: 7-point Investigator-rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Week 16|FAS. N=number of participants with evaluable data.||Participants|||Number
792101|NCT00889603|Secondary|Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 8|CGI-I: 7-point Investigator-rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Week 8|FAS. N=number of participants with evaluable data.||Participants|||Number
792102|NCT00889603|Secondary|Change From Baseline in Functional Activity Questionnaire (FAQ)|Participants completed the FAQ for physical function. Overall scores could have ranged from 0 (independent) to 30 (dependent) where lower scores represented an improvement in physical function. Change from baseline was to be calculated as baseline scores minus week 24 scores.|Baseline and Week 24|FAS. Data not analyzed||Scores on a scale||Standard Deviation|Mean
792103|NCT00889603|Secondary|Change From Baseline in MMSE Total|MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranged from 0 - 30, higher score indicated better cognitive state. Change: least squares (LS) mean score at observation minus LS mean score at baseline. Changes from baseline at each week were controlled for baseline MMSE.|Baseline, Week 8, 16, and 24|FAS. N=number of participants with evaluable data.||Scores on a scale||Standard Error|Least Squares Mean
792104|NCT00889603|Primary|Change From Baseline in Mini Mental State Examination (MMSE) Total at Week 24 Last Observation Carried Forward (LOCF)|MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranged from 0 - 30, higher score indicated better cognitive state. Change: mean score at Week 24 LOCF minus mean score at baseline.|Baseline and Week 24|Full Analysis Set (FAS): all participants who received at least 1 dose of Donepezil and had at least 1 postbaseline efficacy evaluation. LOCF was used. N=number of participants with evaluable data.||Scores on a scale||Standard Error|Mean
792105|NCT00889681|Primary|Long-term Clinical Success|Composite of both Acute Procedural Success and freedom from Chronic Treatment Failure. Freedom from Chronic Treatment Failure (CTF) was defined as no occurrence of an AF Intervention and no occurrence of Detectable AF which is defined as an episode of AF, documented in a tracing, and lasting more than 30 seconds, occurring during a Non Blanked Follow-up Period.|180 days|78 of 81 subjects were treated with cryoablation.||Participants|||Number
792106|NCT00889681|Primary|Freedom From Major Atrial Fibrillation Events (MAFE)|Composite event including: cardiovascular death, hospitalization for: (AF recurrence or ablation, atrial flutter ablation (excluding Type I), systemic embolization (not stroke), congestive heart failure, hemorrhagic event (not stroke)), anti-arrhythmic drug: initiation, adjustment or complication, myocardial infarction, stroke.|365 days|78 of 81 enrolled subjects were treated with cryoablation.||Participants|||Number
792107|NCT00889681|Primary|Acute Procedural Success (APS)|Demonstration of electrical isolation in ≥ 3 pulmonary veins or their anomalous equivalents at the conclusion of the first protocol-defined cryoablation procedure.|At the conclusion of the cryoablation procedure|78 of 81 subjects were treated with cryoablation.||Participants|||Number
792108|NCT00889681|Primary|Cryoablation Procedure Events (CPEs)|Composite event: access site complications, cardiac damage (including myocardial infarction), embolic phenomena (including stroke), arrhythmia, persistent phrenic nerve injury, death and pulmonary vein stenosis.|365 days|78 of the 81 enrolled subjects were treated with cryoablation.||Participants|||Number
792109|NCT00889707|Secondary|Change in Maximum Urinary Flow Rate (Qmax) From Baseline to 3 Months (Qmax at 3 Months Minus Qmax at Baseline)|A printout of uroflowmetry was provided to a central, blinded, independent reviewer for determination of the Qmax values to be used for evaluation of efficacy. The central, independent, blinded reviewer determined the Qmax from over-reads of the uroflowmetry printouts, applying the 2-second rule to reduce variability and increase the accuracy.|3 months after treatment|The protocol-defined efficacy evaluable (EE) primary analysis population, defined as (1) all patients who received the randomized treatment in full, (2) completed the Month 3 efficacy assessments, and (4) did not have a major protocol deviation that could confound the assessment of efficacy as determined by a blinded, independent data review panel||ml/sec||Standard Deviation|Mean
792110|NCT00889707|Primary|Change in International Prostate Symptom Scale (IPSS) of Lower Urinary Tract Symptoms From Baseline to 3 Months (Total Score at 3 Months Minus Total Score at Baseline)|Total of 7 questions regarding lower urinary tract symptoms, with each question scored on a range of 0 (not at all) to 5 (almost always have the symptom). The total score is the summation of all 7 questions, and therefore has a possible range of 0 to 35.|3 months post-treatment|The efficacy evaluable (EE) protocol defined primary analysis population, defined as (1) all patients who received the randomized treatment in full, (2) completed the Month 3 efficacy assessments, and (4) did not have a major protocol deviation that could confound the assessment of efficacy as determined by a blinded, independent data review panel.||score||Standard Deviation|Mean
792111|NCT00889720|Secondary|Number of Treatment Emergent Adverse Events by Severity|Mild: did not interfere with usual function; Moderate: interfered to some extent with usual function; Severe: interfered significantly with usual function. If the same participant in a given treatment had more than one occurrence in the same preferred term event category, only the most severe occurrence was taken. Missing baseline severities were imputed as mild.|Baseline through Week 26 (within 30 days of last dose)|Safety analysis set. N = number of treated subjects. Includes data up to 30 days after last dose of study drug.||events|||Number
792112|NCT00889720|Secondary|Number of Participants With Treatment-Emergent Adverse Events by Type, Severity, Seriousness, and Relatedness to Varenicline|Treatment-emergent AE (TEAE): any untoward medical occurrence that occurred or worsened after beginning study treatment without regard to causal relationship. Treatment-related TEAE: investigator assessment of reasonable possibility that treatment caused or contributed to AE. Severe TEAE: interfered significantly with usual function. SAE: AE resulting in death, initial or prolonged inpatient hospitalization, a life-threatening experience (immediate risk of death), persistent or significant disability/incapacity, congenital anomaly, or deemed significant for any other reason.|Baseline through Week 26 (within 30 days of last dose)|Safety analysis set: participants who took at least 1 dose (including partial doses) of study medication. N = number of treated subjects. Includes data up to 30 days after last dose of study drug.||participants|||Number
792113|NCT00889720|Secondary|Percentage of Participants Who Reduced Their Cigarette Consumption by at Least 50% in the 7 Days Preceding Weeks 12 and 26 Compared With Baseline.||Baseline, Week 12, Week 26|Surgical population: Not analyzed due the limited number of participants recruited.||percentage of participants|||Number
792114|NCT00889720|Secondary|Number of Participants With 7 Day Point Prevalence (PP) for Abstinence in the Week Preceding Week 26|Responder defined as participant who answered “No” to question on Nicotine Use Inventory (NUI), “Has the subject smoked any cigarettes or cigarillos or used any other nicotine containing products in the last 7 days?” Additionally, responder status confirmed by measurement of end-expiratory exhaled carbon monoxide concentration <10 parts per million (ppm).|Week 26|Surgical population: N = number of participants who had a Week 26 visit.||participants|||Number
792115|NCT00889720|Secondary|Number of Participants With 7-day Point Prevalence (PP) for Abstinence From Cigarette Smoking and Other Nicotine Use at the End of Treatment (Week 12)|Responder defined as participant who answered “No” to question on Nicotine Use Inventory (NUI), “Has the subject smoked any cigarettes or cigarillos or used any other nicotine containing products in the last 7 days?” Additionally, responder status confirmed by measurement of end-expiratory exhaled carbon monoxide concentration <10 parts per million (ppm).|Week 12|Surgical population: N = number of participants who had a Week 12 visit.||participants|||Number
792116|NCT00889720|Secondary|Percentage of Participants Who Succeed in Reducing Their Cigarette Consumption by at Least 50% in 7 Days Preceding Hospital Admission Compared With Baseline.||Baseline, Week 8|Surgical population. Not analyzed due the limited number of participants recruited.||percentage of participants|||Number
792117|NCT00889720|Secondary|Number of Participants by Severity of Post-operative Complications: Dindo, Demartines and Clavien Classification System|Grade 0: no post-operative (post-op) complications (comp), Grade 1: any deviation from normal post-op course without need for pharmacological treatment (PT) other than allowed interventions (INT), or surgical, endoscopic or radiological INT; Grade II: required PT with drugs other than those allowed for grade I comp; Grade III required surgical, endoscopic or radiological INT, IIIa: not under general anaesthesia (GA), IIIb: under GA; Grade IV: life-threatening comp requiring IC/ICU management, IVa: single organ dysfunction (DSF), IVb: multiorgan DSF; Grade V: death. Not done = not assessed.|Baseline through Week 26|Surgical Population; N = participants who took at least 1 dose of study medication and received planned surgery. Results provided for participants who had a study visit at timepoint. For participants with more than 1 incidence of surgical complication recorded, the most severe incidence was used for analysis. Abbreviations: PS=post-surgery.||participants|||Number
792118|NCT00889720|Primary|Number of Participants With 7 Day Point Prevalence (PP) for Smoking Abstinence Prior to Hospital Admission.|Responder defined as participant who answered “No” to question on Nicotine Use Inventory (NUI), “Has the subject smoked any cigarettes or cigarillos or used any other nicotine containing products in the last 7 days?” Additionally, responder status confirmed by measurement of end-expiratory exhaled carbon monoxide concentration <10 parts per million (ppm).|7 days prior to hospital admission to day of hospital admission (after Week 8 of treatment)|Surgical population: N = participants who took at least 1 dose of study medication and received planned surgery.||participants|||Number
792119|NCT00889720|Primary|Wound Healing Grade by ASEPSIS Criteria at Week 26|Wound grading scale of wound characteristics assessed by portion of wound infected and point scale for daily wound inspection. Infections categorized by ASEPSIS score as satisfactory healing (0-10), disturbance of healing (11-20), minor wound infection (21-30), moderate wound infection (31-40), and severe wound infection (>40). Surgical site complication defined as total score >10; wound infection defined as total score >20. Not done = not assessed.|Week 26|Surgical Population; N = number of participants who had ASEPSIS wound grading during the study and had a Week 24 visit.||participants|||Number
792120|NCT00889720|Primary|Wound Healing Grade by ASEPSIS Criteria at Week 12|Wound grading scale of wound characteristics assessed by portion of wound infected and point scale for daily wound inspection. Infections categorized by ASEPSIS score as satisfactory healing (0-10), disturbance of healing (11-20), minor wound infection (21-30), moderate wound infection (31-40), and severe wound infection (>40). Surgical site complication defined as total score >10; wound infection defined as total score >20. Not done = not assessed.|Week 12|Surgical Population; N = number of participants who had ASEPSIS wound grading during the study and had a Week 12 visit.||participants|||Number
792121|NCT00889720|Primary|Wound Healing Grade by ASEPSIS Criteria: Post-surgery Days 6 to 10|Wound grading scale of wound characteristics assessed by portion of wound infected and point scale for daily wound inspection. Infections categorized by ASEPSIS score as satisfactory healing (0-10), disturbance of healing (11-20), minor wound infection (21-30), moderate wound infection (31-40), and severe wound infection (>40). Surgical site complication defined as total score >10; wound infection defined as total score >20. Not done = not assessed.|Post-surgery Days 6-10|Surgical Population; N= number of participants who had ASEPSIS wound grading during the study and had a Day 6-10 post-surgery visit.||participants|||Number
792122|NCT00889720|Primary|Wound Healing Grade by ASEPSIS Criteria: Post-surgery Days 1 to 3|Wound grading scale of wound characteristics assessed by portion of wound infected and point scale for daily wound inspection. Infections categorized by ASEPSIS score as satisfactory healing (0-10), disturbance of healing (11-20), minor wound infection (21-30), moderate wound infection (31-40), and severe wound infection (>40). Surgical site complication defined as total score >10; wound infection defined as total score >20. Not done = not assessed.|Post-surgery Days 1-3|Surgical Population; N= number of participants who had ASEPSIS wound grading during the study and had a Day 1-3 post-surgery visit.||participants|||Number
792123|NCT00889720|Primary|Number of Participants With Grade of Wound Healing and Severity of Surgical Site Infections at Week 26: Southampton Wound Assessment Scale|Grade 0 = normal healing (NH); Grade I = NH with (w) mild bruising (br) or haematoma (a: some br, b: considerable br, c: mild erythema); Grade II= erythema plus other signs of inflammation (a: at 1 point, b: around sutures, c: along wnd, d: around wnd); Grade III= clear or haemoserous discharge (a: at 1 point only ≤ 2 cm, b: along wnd > 2 cm, c: large volume, D: prolonged > 3 days); Grade IV= pus (a: at 1 point only ≤ 2 cm, b: along wnd > 2 cm; Grade V=deep or severe wnd infection (w or without tissue breakdown; haematoma requiring aspiration). Not done = not assessed.|Week 26|Surgical Population; N= number of participants with a Week 26 visit.||participants|||Number
792165|NCT00890409|Secondary|Major Adverse Events|Major adverse events were defined as severe arrhythmia (II or III degree A-V block or atrial or ventricular arrhythmia), major venous thrombosis, refractory hypotension (mean blood pressure less than 40 mmHg), moderate or severe scleredema (greater or equal to 20% body surface area), and severe bleeding.|18 months|||participants|||Number
792124|NCT00889720|Primary|Number of Participants With Grade of Wound Healing and Severity of Surgical Site Infections at Week 12: Southampton Wound Assessment Scale|Grade 0 = normal healing (NH); Grade I = NH with (w) mild bruising (br) or haematoma (a: some br, b: considerable br, c: mild erythema); Grade II= erythema plus other signs of inflammation (a: at 1 point, b: around sutures, c: along wnd, d: around wnd); Grade III= clear or haemoserous discharge (a: at 1 point only ≤ 2 cm, b: along wnd > 2 cm, c: large volume, D: prolonged > 3 days); Grade IV= pus (a: at 1 point only ≤ 2 cm, b: along wnd > 2 cm; Grade V=deep or severe wnd infection (w or without tissue breakdown; haematoma requiring aspiration). Not done = not assessed.|Week 12|Surgical Population; N= number of participants with a Week 12 visit.||participants|||Number
792125|NCT00889720|Primary|Number of Participants With Grade of Wound Healing and Severity of Surgical Site Infections Post-surgery Days 6 to 10: Southampton Wound Assessment Scale|Grade 0 = normal healing (NH); Grade I = NH with (w) mild bruising (br) or haematoma (a: some br, b: considerable br, c: mild erythema); Grade II= erythema plus other signs of inflammation (a: at 1 point, b: around sutures, c: along wnd, d: around wnd); Grade III= clear or haemoserous discharge (a: at 1 point only ≤ 2 cm, b: along wnd > 2 cm, c: large volume, D: prolonged > 3 days); Grade IV= pus (a: at 1 point only ≤ 2 cm, b: along wnd > 2 cm; Grade V=deep or severe wnd infection (w or without tissue breakdown; haematoma requiring aspiration). Not done = not assessed.|Post-surgery Days 6-10|Surgical Population; N= number of participants with a Day 6-10 post-surgery visit.||participants|||Number
792126|NCT00889720|Primary|Number of Participants With Grade of Wound Healing and Severity of Surgical Site Infections Post-surgery Days 1 to 3: Southampton Wound Assessment Scale|Grade 0 = normal healing (NH); Grade I = NH with (w) mild bruising (br) or haematoma (a: some br, b: considerable br, c: mild erythema); Grade II= erythema plus other signs of inflammation (a: at 1 point, b: around sutures, c: along wnd, d: around wnd); Grade III= clear or haemoserous discharge (a: at 1 point only ≤ 2 cm, b: along wnd > 2 cm, c: large volume, D: prolonged > 3 days); Grade IV= pus (a: at 1 point only ≤ 2 cm, b: along wnd > 2 cm; Grade V=deep or severe wnd infection (w or without tissue breakdown; haematoma requiring aspiration). Not done = not assessed.|Post-surgery Days 1-3|Surgical Population; N= number of participants with a Day 1-3 post-surgery visit.||participants|||Number
792127|NCT00889720|Primary|Number of Participants With Surgical Site Infections With Microbiological Confirmation of Bacterial Infection|Microbiological confirmation defined as organisms isolated from an aseptically obtained culture of fluid or tissues from the superficial incision.|Post-surgery Days 1-3, Post-surgery Days 6-10, Week 12, Week 26|Surgical Population; Due to satisfactory wound healing in all subjects, microbiological assessment was not necessary and no swabs were taken.||participants|||Number
792128|NCT00889720|Primary|Number of Participants With Surgical Site Infection at Week 26: Center for Disease Control (CDC) Definition|Surgical site infections (SSIs) assessed by 1992 CDC definition; divided into incisional and organ/space SSIs. Incisional space SSIs further classified as involving only skin and subcutaneous tissue (superficial incisional) or involving deep soft tissues (fascial and muscle layers) of the incision (deep incisional ). Organ/space SSIs involve any part of the anatomy (organs or spaces) other than incision opened or manipulated during operative procedure. None = did not have a surgical site infection. Category 0 = no surgical wound complications. Not done = not assessed.|Week 26|Surgical Population; N= number of participants with a Week 26 visit.||participants|||Number
792129|NCT00889720|Primary|Number of Participants With Surgical Site Infection at Week 12: Center for Disease Control (CDC) Definition|Surgical site infections (SSIs) assessed by 1992 CDC definition; divided into incisional and organ/space SSIs. Incisional space SSIs further classified as involving only skin and subcutaneous tissue (superficial incisional) or involving deep soft tissues (fascial and muscle layers) of the incision (deep incisional ). Organ/space SSIs involve any part of the anatomy (organs or spaces) other than incision opened or manipulated during operative procedure. None = did not have a surgical site infection. Category 0 = no surgical wound complications. Not done = not assessed.|Week 12|Surgical Population; N= number of participants with a Week 12 visit.||participants|||Number
792130|NCT00889720|Primary|Number of Participants With Surgical Site Infection Post-surgery Days 6 to 10: Center for Disease Control (CDC) Definition|Surgical site infections (SSIs) assessed by 1992 CDC definition; divided into incisional and organ/space SSIs. Incisional space SSIs further classified as involving only skin and subcutaneous tissue (superficial incisional) or involving deep soft tissues (fascial and muscle layers) of the incision (deep incisional ). Organ/space SSIs involve any part of the anatomy (organs or spaces) other than incision opened or manipulated during operative procedure. None = did not have a surgical site infection. Category 0 = no surgical wound complications. Not done = not assessed.|Post-surgery Days 6-10|Surgical Population; N= number of participants with a Day 6-10 post-surgery visit.||participants|||Number
792131|NCT00889720|Primary|Number of Participants With Surgical Site Infection Post-surgery Days 1 to 3: Center for Disease Control (CDC) Definition|Surgical site infections (SSIs) assessed by 1992 CDC definition; divided into incisional and organ/space SSIs. Incisional space SSIs further classified as involving only skin and subcutaneous tissue (superficial incisional) or involving deep soft tissues (fascial and muscle layers) of the incision (deep incisional ). Organ/space SSIs involve any part of the anatomy (organs or spaces) other than incision opened or manipulated during operative procedure. None = did not have a surgical site infection. Category 0 = no surgical wound complications. Not done = not assessed.|Post-surgery Days 1-3|Surgical Population; N= number of participants with a Day 1-3 post-surgery visit.||participants|||Number
792132|NCT00889720|Primary|Percentage of Fully Compliant Participants|Compliance defined as completed 12 weeks of varenicline therapy, underwent surgery 8 weeks +-10 days after start of varenicline treatment, and had evaluations of wound infection 1 to 3 days and 6 to 10 days after surgery.|Baseline through Week 12|Surgical Population: subset of Full Analysis Set; includes all participants who took at least 1 dose (including partial doses) of study medication and received their planned surgery within the study period. N = participants in surgical population.||percentage of participants|||Number
792133|NCT00889824|Primary|Change in Dynamic Gait Index (DGI) From Baseline to 6 Weeks.|The DGI is designed to measure a patient's functional balance and postural stability on a scale of 0-3 (3 being normal) for each task. A series of 8 tasks including walking on a level surface, walking while changing speeds, walking with head turns, walking then turning, stepping over obstacles, walking around obstacles, and stairs. For a total scale of 0-24.|6 weeks|The Dynamic Gait Index (DGI) data were analyzed by way of an linear mixed (LM) model. The DGI response data were treated as the dependent observations.||units on a scale||Standard Deviation|Mean
792134|NCT00889863|Secondary|Part II: Change in Health Related Quality of Life Over Time by Child Health Questionnaire (CHQ-PF50)|CHQ-PF50 measures Physical functioning, Role/social emotional, behavior and physical, Bodily pain, General behavior, Mental health, Self-esteem, General health perception, Change in health, Parental impact–emotional, Parental impact–time, Family activities and cohesion. Summaries are provided for Physical Health and Psychosocial Health. An increase in score indicates improvement. Repeated measures Analysis of Covariance change from start of Part II with treatment group, visit day, prednisone(or equivalent) dose and adapted ACR70 Pediatric response reached at the end of Part Id as covariates.|Start Part II (Week 32), End Part II (total duration - 88 Weeks)|Full Analysis Set Part II-patients aged 5-18 years.||Score on a scale||Standard Error|Least Squares Mean
792135|NCT00889863|Secondary|Part I: Change in Health Related Quality of Life Over Time by Child Health Questionnaire (CHQ-PF50)|The CHQ-PF50© is an instrument used to measure Health Related Quality of Life in children 5-18 from the parent's perspective. The questionnaire measures the following concepts: Physical functioning, Role/social emotional, Role/social behavior, Role/social physical, Bodily pain, General behavior, Mental health, Self-esteem, General health perception, Change in health, Parental impact – emotional, Parental impact – time, Family activities, and Family cohesion. Summaries are provided for Physical Health and Psychosocial Health. Scores range from 0-100. Increase in score represents improvement.|Baseline, End of Part I ( Week 32)|Participants from the Full Analysis Set Part I-age 5 to 18 years.||Score on a scale||Full Range|Median
792136|NCT00889863|Secondary|Part II: Change in Disability Over Time by the Child Health Assessment Questionnaire-Disability Index (CHAQ-DI)|"CHAQ-DI assessed physical ability and functional status of patients and quality of life. 20 multiple choice items concerning difficulty in performing 8 common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and other “activities”. Parents choose from 4 response categories, ranging from 0(without any difficulty) to 3(unable to do).
Repeated measures Analysis of Covariance with treatment group, visit day, prednisone (or equivalent) dose and adapted ACR 70 response reached at the end of Part Id as covariates."|Start of Part II (Week 32), End of Part II ( total duration-88 weeks)|Full Analysis set Part II.||Score on a scale||Standard Error|Least Squares Mean
792137|NCT00889863|Secondary|Part I: Change in Disability Over Time in the Child Health Assessment Questionnaire-Disability Index (CHAQ-DI) From Baseline to End of Part I|The childhood health assessment questionnaire, CHAQ was used to assess physical ability and functional status of patients as well as quality of life. The disability dimension consists of 20 multiple choice items concerning difficulty in performing eight common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and other “activities”. Parents choose from four response categories, ranging from 0(without any difficulty) to 3(unable to do). A negative change indicates improvement.|Baseline, End of Part I (Week 32)|Participants from the Full Analysis Set Part I with data at baseline and End of Part I.||Score on a scale||Full Range|Median
792138|NCT00889863|Secondary|Part II: Survival Analysis of Time to a Worsening in American College of Rheumatology (ACR) Response|"Kaplan Meier estimate of the time in days to the probability of worsening of the ACR response.
ACR response is determined by the following items:
Physician’s global assessment of disease activity
CHAQ-patient’s overall wellbeing
CHAQ-Functional ability
Number of joints with active arthritis
Number of joints with limitation of motion
C-Reactive Protein.
No intermittent fever in the preceding week"|Part II was event driven. The study was stopped when the required number of 37 flares had occurred (88 weeks)|Full Analysis Set Part II||Days||95% Confidence Interval|Median
792139|NCT00889863|Secondary|Part I: Percentage of Participants With Body Temperature ≤ 38 Degrees Celsius at Day 3 in Part 1a||Day 3|Participants from the Full Analysis Set Part I with temperature readings at Day 3.||Percentage of participants||95% Confidence Interval|Number
792140|NCT00889863|Secondary|Part I: Time to First Minimum American College of Rheumatology (ACR70) and Normal C-Reactive Protein|Duration in days in the study to the first minimum adapted ACR Pediatric 70 criteria and a normal (<10mg/L) C-Reactive Protein|Baseline, Week 32|Participants from the Full Analysis Set Part I with ACR 70 and a Normal CRP.||Days||Standard Deviation|Mean
792141|NCT00889863|Secondary|Part I: Time to First Minimum American College of Rheumatology (ACR50) and Normal C-Reactive Protein|Duration in days in the study to the first minimum adapted ACR Pediatric 50 criteria and a normal (<10mg/L) C-Reactive Protein|Baseline, Week 32|Participants from the Full Analysis Set Part I with ACR 50 and a Normal CRP.||Days||Standard Deviation|Mean
792142|NCT00889863|Secondary|Part I: Percentage of Participants With Minimum American College of Rheumatology (ACR) 30/50/70/90/100 at the End of Part I|"Adapted ACR Pediatric 30/50/70/90/100 criteria are defined as meeting all of the following:
improvement from baseline of ≥ 30%, ≥ 50%, ≥ 70%, ≥ 90%, or 100%, in at least 3 of the first 6 response variables
Physician’s global assessment of disease activity
CHAQ-patient’s overall well-being
CHAQ-Functional ability
# of joints with active arthritis
# of joints with limitation of motion
C-Reactive Protein.
no intermittent fever in the preceding week
no more than one of the first 6 response variables worsening by more than 30%"|Baseline, 32 Weeks|Participants from the full analysis set with an assessment at the given time-point.||Percentage of participants|||Number
792143|NCT00889863|Secondary|Part I: Percentage of Participants on Steroids at the Start of 1c Who Were Able to Taper Steroids by the End of Part 1c||Start of Part Ic (After Week 8) to End of Part Ic (Week 28)|Participants from the Full Analysis set who were taking oral steroids at the start of Part Ic.||Percentage of participants||90% Confidence Interval|Number
792144|NCT00889863|Secondary|Part I: Percentage of Patients on Steroids at Study Start Who Reached a Steroid Dose ≤0.2 mg/kg at End of Part Ic||28 Weeks|Participants from the Full Analysis set who were taking oral steroids at the start of the study.||Percentage of participants||95% Confidence Interval|Number
792145|NCT00889863|Primary|Part II: Survival Estimate of Time to Flare|"Kaplan Meier estimate of the probability to experience a flare. Flare was defined as at least 1 of the following.
Reappearance of fever (>38°C, lasting for at least 2 consecutive days) not due to infections
Flare according to the JIA pediatric criteria for flare (all criteria must have been met):
≥ 30% worsening in at least 3 of the first 6 response variables
≥ 30% improvement in not more than 1 of the first 6 response variables Patients who discontinued the study while in Part II were counted as flared unless they discontinued because of inactive disease for at least 24 weeks in Part II."|Part II was event driven. The study was stopped when the required number of 37 flares had occurred (88 weeks)|Full Analysis Set in Part II||Days||95% Confidence Interval|Median
792146|NCT00889863|Primary|Part I: Percentage of Patients Who Were on Steroids at Entry Into Part I and Who Were Able to Taper Steroid as Per Protocol in at Least 25% of the Patients Who Entered the Study Taking a Steroid|Ability to taper oral steroids: if dose reduced from start of Part I to end of Part Ic from > 0.8 mg/kg/day to ≤ 0.5 mg/kg/day, or from ≥ 0.5 mg/kg/day and ≤ 0.8 mg/kg/day by at least 0.3 mg/kg, or from any initial dose to ≤ 0.2 mg/kg/day, while maintaining a minimum adapted ACR 30 pediatric criterion. Patients on oral steroids at study entry who did not enter Part 1c are considered steroid tapering failures.|32 Weeks|Participants from the Full Analysis Set who were taking oral steroids at the beginning of Part I.||Percentage of participants||90% Confidence Interval|Number
792147|NCT00889915|Secondary|Clinical Global Improvements-Acceptability (CGI-A) Scale|The CGI-A score at the subject's last study visit at or before Week 6 is one of the 3 secondary endpoints that contribute to the primary endpoint (CGI-E). The CGI-A will be used to assess the acceptability of the study medication with respect to the subject's experience with the formulation of medication. The 7-point rating for the CGI-A will be: 1=very high acceptability, 2=high acceptability, 3=above average acceptability, 4=average acceptability, 5=low acceptability, 6=very low acceptability, 7=extremely low acceptability|Measured at each participant's last visit, which can occur at or before Week 6|||Units on a scale||Full Range|Median
792148|NCT00889915|Secondary|Clinical Global Impressions-Improvement (CGI-I) Scale|The CGI-I score at the subject's last study visit at or before Week 6, is one of the 3 secondary endpoints that contribute to the primary endpoint (CGI-E). The CGI-I scale will be used to rate improvement in the subject's condition (benefits) since baseline using the following 7-point scale: 1=very much improved, 2=much improved, 3=minimally improved, 4=not changed, 5=minimally worse, 6=much worse; 7=very much worse.|Measured at each participant's last visit, which can occur at or before Week 6|||Units on a scale||Full Range|Median
792149|NCT00889915|Primary|Dichotomized Clinical Global Impression-Effectiveness (CGI-E) Scale|The CGI-E is the value at which the participant's Therapeutic Benefit and Adverse Impact to the study drug intersect. This number is determined by combining each participant's scores for the degree of Therapeutic Benefit versus the degree to which problems with Tolerability and/or Acceptability adversely impact the subject. Participants are then determined to be Responders or Non-responders to the study medication. For example, a subject who is very much improved (CGI-I=1) or much improved (CGI-I=2) therapeutically and whose adverse impact rating is none (score 1,5) or mild (score 2,6) will be categorized as a Responder. All others whose adverse impact rating is moderate (score 3,7,11,15)or outweighs therapeutic effect (score 4,8,12,16) will be categorized as Non-responders to study medication. The CGI scores are totaled for each participant and a mean score is calculated. A median total score was calculated for each treatment group.|Measured at each participant's last visit, which can occur at or before Week 6|||Units on a scale||Full Range|Median
792150|NCT00889928|Primary|Procedure Completion|Completion of procedure - transvaginal removal of the gallbladder|Day of Surgery|All subjects on whom the procedure was attempted.||participants|||Number
792151|NCT00890084|Secondary|Percentage of Prescribers Who Adhered to European Society of Hypertension/European Society of Cardiology (ESH/ESC) Guidelines 2007|Blood pressure should be reduced to at least below 140/90 mm Hg (systolic/diastolic),and to lower values, if tolerated, in all hypertensive patients. Target blood pressure should be lower than 130/80 mmHg in diabetics and in high or very high risk patients|12 weeks|all investigators participating in the trial||percentage of prescribers||95% Confidence Interval|Number
792152|NCT00890084|Secondary|Percentage of Patients in Whom the Prescriber Decide to Further Lower the Blood Pressure to < 130/80 mm Hg||12 weeks|Intention to treat (ITT)||percentage of patients||95% Confidence Interval|Number
792153|NCT00890084|Secondary|Change in Concomitant Antihypertensive Drugs Given at Study Entry|Percentage of patients who had a change in concomitant antihypertensive drugs prescribed at initiation and after 12 weeks. The antihypertensive drugs were changed (which is stopped, titration of dose and started) or not.|baseline and 12 weeks|Intention to treat (ITT)||percentage of patients||95% Confidence Interval|Number
792154|NCT00890084|Secondary|Treatment Patterns|Treatment patterns observed at the end of the study as Micardis monotherapy, Micardis Plus 12.5 and Micardis Plus 25 (with or without changes in concomitant antihypertensive medications).|12 weeks|ITT Population||Percentage of patients|||Number
792155|NCT00890084|Secondary|BP Response Rate (Drop of Systolic BP of 10mmHg or More)|BP response rate (drop of systolic BP of ≥ 10mmHg) after approximately 12 weeks of treatment with telmisartan (alone or in fixed combination with HCTZ)|12 weeks|ITT Population||Percentage of patients||95% Confidence Interval|Number
792156|NCT00890084|Secondary|Absolute Blood Pressure Decrease|systolic blood pressure|baseline and 12 weeks|Intention to treat (ITT)||mm Hg||95% Confidence Interval|Mean
792157|NCT00890084|Secondary|Percentage of Patients With Blood Pressure < 130/80 mm Hg||12 weeks|Intention to Treat (ITT)||Percentage of participants||95% Confidence Interval|Number
792158|NCT00890084|Primary|Percentage of Patients With Blood Pressure < 140/90 mm Hg|% of high risk patients with Blood Pressure < 140/90 mm Hg|12 weeks|Intention-to-Treat (ITT)||Percentage of participants||95% Confidence Interval|Number
792159|NCT00890097|Primary|Mean Annualized Lesion Enlargement Rate From Baseline as Assessed With Fundus Autofluorescence Imaging|The size of the retinal lesion was measured using the Heidelberg Retinal Angiography system at Baseline, Month 6, Month 12, Month 15, Month 18, Month 24, and Month 30. Images were collected in both eyes; however, one eye from each subject was chosen as the study eye, and only data for the study eye were used for the efficacy analysis. Results were estimated from a longitudinal random effects regression model. A greater lesion growth rate may indicate a faster progression of the disease.|Baseline, up to Month 30|This analysis population included all treated subjects. A subject was considered treated if they had a first or last dosing date in the database.||square millimeters per year||95% Confidence Interval|Mean
792160|NCT00890201|Secondary|Normal Preoperative Serum Values of Amylase and Lipase||24 hours||||||
792161|NCT00890201|Secondary|Normal Operative Cholangiography||24 hours||||||
792162|NCT00890201|Secondary|Amylase and Lipase Values in Gallbladders With Cholelithiasis||24 hours||||||
792163|NCT00890201|Secondary|Amylase and Lipase Values in Normal Gallbladders||24 hours||||||
792164|NCT00890201|Primary|Amylase and Lipase Values in Gallbladder Bile|Normal values of lipase and amylase in gallbladder bile should be zero|24 hours|The number of participants analyzed was determined by the number of participants that matched the inclusion criteria. As posted elsewhere some participants were excluded from this analysis based in the exclusion criteria of the protocol.||mg/dl||Standard Deviation|Mean
792166|NCT00890409|Primary|Severe Neurodevelopmental Disability|Severe disability was defined as cerebral palsy (CP) or mental retardation (MR). The definition of MR was development quotient (DQ) <70 by Gesell’s Child Development Scale and CP was based on the Criteria of a level 3 to 5 by the Gross Motor Function Classification System (GMFCS).|18 months|||participants|||Number
792167|NCT00890409|Primary|Death|The number of deaths by 18 months of age.|18 months|||participants|||Number
792168|NCT00890552|Secondary|Duration of Response|Assessed as the median value for the time from first partial response until progression; death; or last follow-up.|32 months|All participants who achieved at least a partial response (9 subjects were not included due to not having any response)||months||Full Range|Median
792169|NCT00890552|Secondary|Event-free Survival (EFS)|Assessed as the median value for EFS 12 months after starting MDR treatment|12 months|All participants starting MDR treatment||months||Full Range|Median
792170|NCT00890552|Secondary|Overall Survival (OS)|Participants alive 12 months after starting MDR treatment.|12 months|All subjects receiving MDR treatment.||percentage of participants|||Number
792171|NCT00890552|Primary|Hematologic Response Rate|At the end of each treatment cycle (4 weeks), hematologic response rate as assessed. Hematologic response was considered to be amyloid complete response (normal FLC ratio and negative serum and urine immunofixation); very good partial response (difference between involved and uninvolved FLCs [dFLC] < 40 mg/L); or partial response (dFLC decrease > 50%).|8 weeks|Subjects completing at least one full cycle of study treatment||participants|||Number
792172|NCT00890591|Primary|Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in Third Titrated Group (Olmesartan + Hydrochorothiazide + Amlodipine)|Number of patients that achieved a blood pressure goal of less than 130/85 in third titrated group (olmesartan 40 mg + 25 mg hydrochlorothiazide + amlodipine 5 mg). This combination was maintained as long as the participant's blood pressure remained within predefined parameters. If not, participant discontinued for lack of efficacy.|4 - 9 weeks|32 subjects started the third and final titration regimen and 12 met their blood pressure goals. 20 dropped out for lack of efficacy.||Participants|||Number
792173|NCT00890591|Primary|Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in Second Titrated Group (Olmesartan 40 mg + 25 mg Hydrochlorothiazide)|Number of patients that achieved a blood pressure goal of less than 130/85 in second titrated group (olmesartan 40 mg + 25 mg hydrochlorothiazide). If BP was > or = to 140/90 at 4,8, or 9 wks the participant went to next level of medication for an additional 4-9 weeks.|4 to 9 weeks|73 patients started the second titration regimen and 41 met their blood pressure goal. There were no dropouts. 32 started the final titration regimen.||Participants|||Number
792174|NCT00890591|Primary|Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in First Titrated Group (Olmesartan 20 mg + 12.5 mg Hydrochlorothiazide)|Number of patients that achieved a blood pressure goal of less than 130/85 in first titrated group (olmesartan 20 mg + 12.5 mg hydrochlorothiazide)If BP was > or = to 140/90 at 4,8, or 9 wks the participant went to next level of medication for an additional 4-9 weeks|4 to 9 weeks on combination therapy|In this first titration group 106 patients started and 33 achieved their blood pressure goal. There were no dropouts and 73 subject started the second titration regimen.||Participants|||Number
792175|NCT00890591|Primary|Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 (Olmesartan 20 mg Monotherapy)|Number of patients that achieved a blood pressure (BP) goal of less than 130/85 in the first group (olmesartan monotherapy 20 mg). If BP was > or = to 140/90 at 4,8, or 9 wks the participant went to next level for an additional 4-9 weeks at the next medication level|4 - 9 wks of olmesartan monotherapy|In this first dosage group 144 started and 38 patients met their blood pressure goal; therefore, 106 started the first titration regimen. There were no dropouts.||Participants|||Number
792176|NCT00890656|Primary|Number of Participants With Complete Remission|Complete remission (CR) required a marrow with ≤ 5% blasts in a normo- or hypercellular marrow with an absolute neutrophil count (ANC) of ≥ 1 * 10^9/L and a platelet count of ≥ 100 * 10^9/L with complete resolution of all sites of extramedullary disease required.|Response evaluated following first course at 14 -21 days and 1-2 weeks later to confirm response status (or at the time of hematologic recovery) and with visits every 2-3 courses.|||Participants|||Number
792177|NCT00890682|Secondary|Adverse Event Profile|Participants with an Adverse Event through 72 hours or a Serious Adverse Event through 30 days|30 days||||||
792178|NCT00890682|Primary|Area Under the Curve (AUC) of the Numeric Rating Scale at Rest (NRS-R) Pain Intensity Scores|"The AUC of the NRS-R pain intensity scores from time 0 through 24 hours
The subject was to rest for at least 5 minutes before responding to the following question, “On a scale of 0 to 10, where 0 = no pain and 10 = worst possible pain, how much pain are you having right now?”"|0-24 hours|||Units on a scale*hours||Standard Error|Geometric Mean
792179|NCT00890695|Secondary|Hospital Admission or Death||from enrolment to 3 months|All participants recruited until trial halted||participants|||Number
792180|NCT00890695|Secondary|Anemia (Hb <9.3g/dl)||at 4 weeks|All participants recruited until trial halted||participants|||Number
792181|NCT00890695|Secondary|Development of Severe Malnutrition (WHZ Score <-3 and/or Kwashiorkor)||at 4 weeks and 3 months|All participants recruited until trial halted||participants|||Number
792182|NCT00890695|Secondary|MUAC for Age Z Score at 3 Months||between enrolment and 4 weeks and at 3 months|All participants recruited until trial halted||Z score||95% Confidence Interval|Mean
792183|NCT00890695|Secondary|WHZ Score at 3 Months||between enrolment and 3 months|All participants recruited until trial halted||Z scores||95% Confidence Interval|Mean
792184|NCT00890695|Primary|Weight for Height z Score at 4 Weeks|"The primary endpoint is weight for height z scores (WHZ), calculated from weight and height measures with reference to the WHO growth standards 2006. WHZ is a measure of wasting and acute malnutrition.
A WHZ of zero is the median value of the reference population. Negative scores indicate undernutrition. Moderate and severe acute malnutrition are defined as WHZ<-2 and <-3 respectively. These correspond to 2 and 3 standard deviations below the reference median.
Of all the anthropometric measures in regular use, WHZ and mid upper arm circumference (MUAC) have the strongest associations with infectious disease incidence and risk of death. WHZ is more appropriate than Weight for Age (WAZ), which is normally used in growth monitoring, because WAZ measures a combination of wasting and stunting (chronic malnutrition). Stunting is unlikely to be affected by short term intervention. WHZ is assessed by anthropometry, following WHO guidelines."|between enrolment and 4 weeks|All participants recruited until trial was halted||units on a scale||95% Confidence Interval|Mean
792186|NCT00890721|Primary|The Area Under the Curve (AUC) of the Numeric Rating Scale at Rest (NRS-R) Pain Intensity Scores Through 72 Hours for Subjects Receiving SKY0402 vs. Placebo.|To assess pain intensity at rest (NRS-R), the subject was to assume a resting position that did not exacerbate his or her postoperative pain and respond to the following question: “On a scale of 0 to 10, where 0 = no pain and 10 = worst possible pain, how much pain are you having right now?”|72 hours|||units on a scale*hr||Standard Error|Least Squares Mean
792187|NCT00890916|Primary|Grasp Release Test - Test of Functional Ability to Pick up and Move Objects|Grasp and Release Test (GRT) - The Grasp and Release Test (GRT) [Wuolle, 1994; Smith et al., 1996; Carroll et al., 2000; Taylor et al., 2002; Mulcahey et al., 2004], developed at the Cleveland FES Center, has been utilized by multiple centers to show improvements in hand function after implantation of a neuroprosthesis and tendon transfers [Peckham, 2001]. This pick-and-place test requires the participant to unilaterally acquire, move, and release six objects varying in weight and size. The objects are: 1) a small peg, 2) a wooden cube, 3) a small juice can, 4) a videotape, 5) a paperweight (~1000g) and a simulated fork task (spring-loaded plunger). The number of objects that the participant can successfully manipulate are scored. Success in manipulating each object in the GRT is defined as the ability to pick up and place the object at least once within 30 seconds.|6-9 weeks|||Number of Completions||Full Range|Median
792188|NCT00890929|Secondary|OS of Responders|OS from the start of treatment of responders (per ELN guidelines) was assessed at a median follow up of 88 weeks from the end of treatment (range, 1-120), and was censored at 1 April 2012.|88 weeks (median)|||weeks||Full Range|Median
792189|NCT00890929|Secondary|Time to PR|Responses were assessed according to the ELN guidelines.|36 weeks|||weeks||Full Range|Median
792190|NCT00890929|Secondary|Time to CR|CR includes subjects with CR but incomplete recovery of blood counts (CRi). Responses were assessed according to the ELN guidelines.|18 weeks|||weeks||Full Range|Median
792191|NCT00890929|Secondary|Overall Survival (OS)|OS from the start of treatment was assessed at a median follow up of 88 weeks from the end of treatment (range, 1-120), and was censored at 1 April 2012.|88 weeks (median)|||weeks||Full Range|Median
792192|NCT00890929|Secondary|Overall Response Rate (ORR)|ORR includes subjects with CR, CRi, and partial response (PR). Responses were assessed according to the ELN guidelines.|26 months|||percentage of subjects|||Number
792193|NCT00890929|Secondary|Remission Duration|Responses and remission were assessed according to the ELN guidelines.|26 months|||weeks||Full Range|Median
792194|NCT00890929|Secondary|Maximum Tolerated Dose (MTD) of Lenalidomide|The MTD of lenalidomide was determined in study phase I, for use in study Phase II.|15 months|||mg/day lenalidomide (oral)|||Number
792195|NCT00890929|Secondary|4-week Survival Rate|"Early death was assessed as death within 28 days of the start of treatment"|28 days|||percentage of subjects remaining alive|||Number
792196|NCT00890929|Primary|Compete Remission (CR) Rate|CR includes subjects with CR but incomplete recovery of blood counts (CRi). Responses were assessed according to the European LeukemiaNet (ELN) guidelines.|12 months|||percentage of subjects|||Number
792197|NCT00890981|Secondary|Actual Value of Procollagen Type 1 N-terminal Peptide|Actual value of Type 1 N-terminal Peptide as measured from blood samples taken on Day 1 (an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179).|Day 1|Participants with observed data.||µg/L||95% Confidence Interval|Least Squares Mean
792198|NCT00890981|Secondary|Actual Value of Serum Type I C-telopeptide|Actual value of Serum Type I C-telopeptide measured from blood samples taken on Day 1 (an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179).|Day 1|Participants with observed data.||ng/mL||95% Confidence Interval|Least Squares Mean
792199|NCT00890981|Secondary|Percent Change of Total Radius BMD From the Parent Study Baseline by DXA|Percent change of total radius BMD from the 20050179 Baseline as determined by DXA at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179.|Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.|Participants with observed data.||Percent change||95% Confidence Interval|Least Squares Mean
792200|NCT00890981|Secondary|Percent Change of Ultradistal Radius BMD From the Parent Study Baseline by DXA|Percent change of ultradistal radius BMD from the 20050179 Baseline as determined by DXA at an average of 32 months since last the subcutaneous dose of denosumab or placebo in study 20050179.|Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.|Participants with observed data.||Percent change||95% Confidence Interval|Least Squares Mean
792201|NCT00890981|Secondary|Percent Change of Distal 1/3 Radius BMD From the Parent Study Baseline by DXA|Percent change of distal 1/3 radius BMD from the 20050179 Baseline as determined by dual energy X-ray absorptiometry (DXA) at an average of 32 months since last subcutaneous dose of denosumab or placebo in study 20050179.|Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.|Participants with observed data.||Percent change||95% Confidence Interval|Least Squares Mean
792202|NCT00890981|Secondary|Percent Change From the Parent Study Baseline in Trabecular BMD at the Distal Tibia by HR-pQCT|Percent change from the 20050179 Baseline in trabecular BMD at the distal tibia as determined by HR-pQCT at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179.|Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.|Participants with observed data.||Percent change||95% Confidence Interval|Least Squares Mean
792203|NCT00890981|Secondary|Percent Change From the Parent Study Baseline in Cortical BMD at the Distal Tibia by HR-pQCT|Percent change from the 20050179 Baseline in cortical BMD at the distal tibia as determined by HR-pQCT at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179.|Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.|Participants with observed data.||Percent change||95% Confidence Interval|Least Squares Mean
792389|NCT00891982|Primary|Local Tolerability - Skin Scaling|"Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:
0 - None
- Trace
- Mild
- Moderate
- Marked
- Severe"|Week 4|||Participants|||Number
792204|NCT00890981|Secondary|Percent Change From the Parent Study Baseline in Total BMD at the Distal Tibia by HR-pQCT|Percent change from the 20050179 Baseline in total BMD at the distal tibia as determined by HR-pQCT at an average of 32 months since last subcutaneous dose of denosumab or placebo in study 20050179.|Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.|Participants with observed data.||Percent change||95% Confidence Interval|Least Squares Mean
792205|NCT00890981|Secondary|Percent Change From the Parent Study Baseline in Cortical Thickness at the Distal Tibia by HR-pQCT|Percent change from the 20050179 Baseline in cortical thickness at the distal tibia as determined by HR-pQCT at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179.|Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.|Participants with observed data.||Percent change||95% Confidence Interval|Least Squares Mean
792206|NCT00890981|Secondary|Percent Change From the Parent Study Baseline in Trabecular BMD at the Distal Radius by HR-pQCT|Percent change from the 20050179 Baseline in trabecular BMD at the distal radius as determined by HR-pQCT at an average of 32 months since last subcutaneous dose of denosumab or placebo in study 20050179.|Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.|Participants with observed data.||Percent change||95% Confidence Interval|Least Squares Mean
792207|NCT00890981|Secondary|Percent Change From the Parent Study Baseline in Cortical BMD at the Distal Radius by HR-pQCT|Percent change from the 20050179 Baseline in cortical BMD at the distal radius as determined by HR-pQCT at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179.|Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.|Participants with observed data.||Percent change||95% Confidence Interval|Least Squares Mean
792208|NCT00890981|Secondary|Percent Change From the Parent Study Baseline in Total Bone Mineral Density (BMD) at the Distal Radius by HR-pQCT|Percent change from the 20050179 Baseline in total BMD at the distal radius as determined by HR-pQCT at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179.|Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.|Participants with observed data.||Percent change||95% Confidence Interval|Least Squares Mean
792209|NCT00890981|Primary|Percent Change From the Parent Study Baseline in Cortical Thickness at the Distal Radius by HR-pQCT|Percent change from the 20050179 Baseline in cortical thickness at the distal radius as determined by high-resolution peripheral quantitative computed tomography (HR-pQCT) at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179.|Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.|Participants with observed data.||Percent change||95% Confidence Interval|Least Squares Mean
792210|NCT00891020|Secondary|Change From Baseline in Fatigue Visual Analogue Scale (VAS) at Weeks 8, 16, and 24|The fatigue VAS is a single-item, patient-reported outcome that measures the severity of the fatigue over the past week. Patients rate their fatigue on a scale of 0 (fatigue is no problem) to 100 (fatigue is a major problem). Higher scores represent higher disease activity and a negative change from baseline indicates improvement.|Baseline, Weeks 8,16,24|"Intent-to-treat population includes all participants who received at least 1 dose of study drug. Patients were included in the treatment group to which they were randomized or assigned, regardless of the treatment actually received. n in each of the categories is the number of participants with data available for analysis at the given time point."||Score on a scale||Standard Deviation|Mean
792211|NCT00891020|Secondary|Change From Baseline in Routine Assessment Patient Index Data (RAPID3) Score at Weeks 8, 16, and 24|The RAPID3 is a combined index derived from the Multidimensional Health Assessment Questionnaire that includes physical function score, pain Visual Analog Scale (VAS), and global assessment of disease activity VAS. The total RAPID3 score ranges from 0 to 10 where higher scores represent worse outcomes. A negative change from baseline indicates improvement.|Baseline, Weeks 8,16,24|"Intent-to-treat population includes all participants who received at least 1 dose of study drug. Patients were included in the treatment group to which they were randomized or assigned, regardless of the treatment actually received. n in each of the categories is the number of participants with data available for analysis at the given time point."||Score on a scale||Standard Deviation|Mean
792212|NCT00891020|Secondary|Number of Participants Having Their Tocilizumab Dose Increased From 4 mg/kg to 8 mg/kg at Weeks 12, 16, and 20|Dosage of Tocilizumab 4 mg/kg could be increased to 8 mg/kg at the discretion of the investigator based on assessment of the patient’s benefit-risk after Week 12.|Weeks 12,16, 20|"Safety population includes participants who received at least one dose of study drug. n in each of the categories is the number of participants previously on 4mg/kg + DMARD and receiving a dose at the current visit. Patients were assigned as using a nonbiologic DMARD if they took at least 1 dose of nonbiologic DMARD during the treatment period."||Participants|||Number
792213|NCT00891020|Secondary|Percentage of Participants With Tocilizumab Dose Increased From 4 mg/kg to 8 mg/kg at Week 8|Dosage could be increased from 4 mg/kg Tocilizumab to 8 mg/kg due to failure to achieve 20% improvement from baseline in swollen and tender joint counts.|Baseline, Week 8|Safety Population. Patients were included in the TCZ dose group according to the first infusion they actually received. Patients were assigned as using a nonbiologic DMARD if they took at least 1 dose of nonbiologic DMARD during the treatment period. Patients who did not take at least 1 dose of nonbiologic DMARD were considered as on monotherapy.||Percentage of Participants|||Number
792226|NCT00879034|Primary|The Primary Objective of This Study is to Evaluate the Feasibility of Administering Intravenous Zoledronic Acid, Oral Pravastatin and Oral Lonafarnib, to Patients With Progeria for a Minimum of 4 Weeks|Feasibility was assessed by determining the number of participants with adverse events occurring over the course of the 4 week study.|4 weeks|Results are reported for the 5 patients who completed the 4 weeks of therapy.||Participants|||Count of Participants
792227|NCT00879190|Secondary|Neonatal Clinical Sepsis (Early Onset)||Up to 6 weeks after delivery|||affected neonates|||Number
792228|NCT00879190|Secondary|Composite Maternal Morbidity|Composite of maternal postpartum morbidity defined as any of the following outcomes: endometritis, clinical sepsis, pneumonia, blood transfusion or ileus.|Up to 6 weeks after delivery|||Participants|||Count of Participants
792214|NCT00891020|Secondary|Percentage of Participants Achieving American College of Rheumatology (ACR) (ACR20/50/70) Responses at Weeks 8, 16, and 24|"The ACR response rates ACR20, ACR50, and ACR70 are defined as ≥20%, ≥50%, and ≥70% improvement from baseline, respectively, in:
Swollen Joint Count (66 joints) and Tender Joint Count (68 joints) and
At least 3 of the following 5 assessments:
Patient’s global assessment of pain-Visual Analog Scale (VAS)
Patient global assessment of disease activity-(VAS)
Physician global assessment of disease activity-(VAS)
Patient assessment of disability (physical function scale of the Multidimensional Health Assessment Questionnaire)
Acute phase response C-Reactive Protein (CRP)"|Baseline, Weeks 8,16,24|Intent-to-treat population includes all participants who received at least one dose of study drug. Patients were included in the treatment group to which they were randomized or assigned, regardless of the treatment actually received.||Percentage of Participants|||Number
792215|NCT00891020|Secondary|Change From Baseline in DAS28 Score at Weeks 8, 16 and 24|"The DAS28 is a combined index for measuring disease activity in rheumatoid arthritis (RA). The index includes tender joint count (TJC) -28 joints and swollen joint count (SJC)-28 joints, acute phase response C-reactive protein (CRP) and general health status. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of < 2.6 represents clinical remission, a score of ≤ 3.2 represents low disease activity, and a score of > 5.1 represents high disease activity.
The Change from Baseline to Weeks 8, 16 and 24 is reported."|Baseline, Weeks 8,16,24|"Intent-to-treat includes participants who received at least one dose of study drug. Patients were included in the treatment group to which they were randomized or assigned, regardless of the treatment actually received. n in each of the categories is the number of participants with data available for analysis at the given time point."||Score on a scale||Standard Deviation|Mean
792216|NCT00891020|Secondary|Percentage of Participants Achieving Clinical Remission at Weeks 8, 16, and 24|Clinical Remission is defined as a Disease Activity Score 28 [DAS28] < 2.6. The DAS28 is a combined index for measuring disease activity in RA. The index includes tender joint count (TJC) -28 joints and swollen joint count (SJC)-28 joints, acute phase response (CRP) and general health status. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.|Weeks 8,16,24|"Intent-to-treat population includes participants who received at least one dose of study drug. Patients were included in the treatment group to which they were randomized or assigned, regardless of the treatment actually received. n in each of the categories is the number of participants with data available for analysis at the given time point."||Percentage of Participants|||Number
792217|NCT00891020|Secondary|Percentage of Participants Experiencing Non-serious Adverse Events of Special Interest|"Non-serious adverse Events of Special interest include:
Serious/Medically Significant Hepatic Events
Spontaneous /Serious Bleeding
Malignant Neoplasms"|24 Weeks|Safety Population. Patients were included in the TCZ dose group according to the first infusion they actually received. Patients were assigned as using a nonbiologic DMARD if they took at least 1 dose of nonbiologic DMARD during the treatment period. Patients who did not take at least 1 dose of nonbiologic DMARD were considered as on monotherapy.||Percentage of Participants|||Number
792218|NCT00891020|Secondary|Percentage of Participants Experiencing Serious Adverse Events of Special Interest|"Serious Adverse Events of Special interest include:
Serious infections including opportunistic infections
Complications of diverticulitis (including lower gastrointestinal [GI] perforations)
Myocardial infarction/acute coronary syndrome
Stroke
Spontaneous or serious bleeding
Malignant neoplasms"|24 Weeks|Safety Population. Patients were included in the TCZ dose group according to the first infusion they actually received. Patients were assigned as using a nonbiologic DMARD if they took at least 1 dose of nonbiologic DMARD during the treatment period. Patients who did not take at least 1 dose of nonbiologic DMARD were considered as on monotherapy.||Percentage of Participants|||Number
792219|NCT00891020|Primary|Percentage of Participants Experiencing at Least One Serious Adverse Event (SAE) During the 24 Week Treatment Period|"An SAE was any adverse event that at any dose fulfilled at least one of the following criteria:
Was fatal (results in death)
Was life-threatening
Required in-patient hospitalization or prolongation of existing hospitalization
Resulted in persistent or significant disability/incapacity
Was a congenital anomaly/birth defect
Was medically significant or required intervention to prevent one or other of the outcomes listed above."|24 Weeks|Safety Population. Patients were included in the TCZ dose group according to the first infusion they actually received. Patients were assigned as using a nonbiologic DMARD if they took at least 1 dose of nonbiologic DMARD during the treatment period. Patients who did not take at least 1 dose of nonbiologic DMARD were considered as on monotherapy.||Percentage of Participants|||Number
792220|NCT00878969|Primary|Interleukin-6 (IL-6)|IL-6 is a sensitive laboratory assay for serum levels of interleukin-6, which is a pro-inflammatory cytokine used to evaluate the inflammatory response.|baseline and 18 months|Based on our power calculations, we needed 210 subjects to complete the study to be able to detect an effect. Given that only 37 subjects completed the study (18% of goal), no formal analyses were performed. Specifically, data were not collected for this assessment for any of the participants enrolled in the study.|||||
792221|NCT00879034|Secondary|To Obtain Baseline Clinical and Laboratory Data so That Longer-term Measures of Efficacy Will be Achievable if Treatment Continues Beyond the 4-week Feasibility Study Period.|The number of participants from whom baseline clinical and Laboratory data was obtained.|4 weeks|||Participants|||Count of Participants
792222|NCT00879034|Secondary|To Assay for the Inhibition of HDJ-2 Farnesylation in Peripheral Blood Leukocytes (PBL)||4 weeks|This data was not collected for this feasibility study. HDJ-2 assessment in these 5 patients was analyzed at the end of a different protocol, NCT00916747.|||||
792223|NCT00879034|Secondary|To Assess the Pharmacokinetics of Lonafarnib in Patients With Progeria.||4 weeks|This data was not collected for this feasibility study. Pharmacokinetics assessment of lonafarnib in these 5 patients was analyzed at the end of a different protocol, NCT00916747.|||||
792224|NCT00879034|Secondary|To Investigate Which Clinical and Laboratory Studies Are Needed to Monitor or Alter Therapy to Prevent Unacceptable Toxicity|The number of participants with abnormal CBC w/diff panel, LFTs, renal functions and lipid panels.|4 weeks|||Participants|||Count of Participants
792225|NCT00879034|Secondary|To Describe Any Acute and Chronic Toxicities Associated With Treating Progeria Patients With the Combination of Zoledronic Acid, Pravastatin and Lonafarnib|Number of participants with acute and chronic toxicities associated with treating progeria patients with the combination of zoledronic acid, pravastatin and lonafarnib|4 weeks|||Participants|||Count of Participants
792230|NCT00879229|Secondary|Change in QOL Score as Assessed by the St. George’s Respiratory Questionnaire (SRGQ)|The SRGQ is designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Patients respond to questions about symptoms (frequency & severity) and impact components (social functioning and psychological disturbances resulting from airways disease). Scores range from 0 to 100, with higher scores indicating more limitations.|Baseline to Week 16|Insufficient data due to study termination|||||
792231|NCT00879229|Secondary|Change in Quality of Life (QOL) Score as Assessed by the Short-Form 36® (SF-36)|Each SF-36 score is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. An increase in score indicates an improvement in health state.|Baseline to Week 16|Insufficient data due to study termination|||||
792232|NCT00879229|Secondary|Hemoglobin-corrected Diffusing Capacity for Carbon Monoxide (DLCO) Percent Predicted|DLCO is a pulmonary function test, and measures the partial pressure difference between inspired and expired carbon monoxide. DLCO% predicted is defined as DLCO% of the patient divided by the average DLCO% in the population for any person of similar age, sex and body composition.|Baseline to Week 16|Insufficient data due to study termination|||||
792233|NCT00879229|Secondary|Change From Baseline in the Borg Dyspnea Index (BORG) Immediately Following Exercise|Borg Dyspnea Index is a measure of perceived shortness of breath: 0 units on a scale (none) to 10 units on a scale (maximum breathlessness).|Baseline to Week 16|Insufficient data due to study termination|||||
792234|NCT00879229|Secondary|Change From Baseline in N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP)|Assessment of the the level of the amino acid fragment NT-proBNP is used to establish prognosis in cardiovascular disease.|Baseline to Week 16|Insufficient data due to study termination|||||
792235|NCT00879229|Secondary|Change From Baseline in Forced Vital Capacity (FVC) Percent Predicted|FVC is a pulmonary function test, and is defined as the volume of air that can forcibly be blown out after taking a full breath. FVC% predicted is defined as FVC% of the patient divided by the average FVC% in the population for any person of similar age, sex and body composition.|Baseline to Week 16|Insufficient data due to study termination|||||
792236|NCT00879229|Secondary|Change From Baseline in WHO Functional Class|"WHO functional class rates severity of pulmonary hypertension, with 4 categories on a scale of 1 to 4 with the worst category being 4. Change is represented as an increase (+1: Improved), decrease (-1: Deteriorated), or no change (0: No change) on the scale."|Baseline to Week 16|Participants in the Full Analysis Set with evaluable data were analyzed.||units on a scale|||Number
792237|NCT00879229|Secondary|Transition Dyspnea Index (TDI)|"The change in TDI at Week 16 (end of blinded treatment) was evaluated. TDI measures the change from the baseline characteristic Baseline Dyspnea Index. The TDI range is -9 to +9 (worst to best; 0 = no change)."|Baseline to Week 16|Participants in the Full Analysis Set with evaluable data were analyzed.||units on a scale||Standard Deviation|Mean
792238|NCT00879229|Secondary|Long-term Survival|Long-term survival was assessed as a Kaplan-Meier (KM) estimate of the percent probability of survival, with censoring at Week 48.|Week 48|Full Analysis Set||percent probability (KM% estimate)||95% Confidence Interval|Number
792239|NCT00879229|Primary|Change From Baseline in Six-minute Walk Distance (6MWD).|The change from baseline in 6MWD at Week 16 (end of blinded treatment) was evaluated.|Baseline to Week 16|Participants in the Full Analysis Set (randomized and received at least one dose of study medication) with evaluable data were analyzed.||meters||Standard Error|Mean
792240|NCT00879255|Primary|Clinician Administered PTSD Scale, for DSM-IV (CAPS IV)|The CAPS is a 30-item interview measure that assesses the frequency and intensity of PTSD symptoms during the past month and the impact these symptoms have had on social and occupational functioning. The CAPS also provides a global scale score of PTSD severity (range 0 - 136) with higher scores indicating worse symptoms, which was used as the primary outcome measure. Scores reported here are differences between individuals follow up scores (e.g. 6-month post-treatment) minus their baseline CAPS scores, such that negative numbers represent reductions in CAPS scores (or improve) over time.|6 months post-treatment|||units on a scale||Standard Error|Mean
792241|NCT00879255|Primary|Clinician Administered PTSD Scale, for DSM-IV (CAPS IV)|The CAPS is a 30-item interview measure that assesses the frequency and intensity of PTSD symptoms during the past month and the impact these symptoms have had on social and occupational functioning. The CAPS also provides a global scale score of PTSD severity (range 0 - 136) with higher scores indicating worse symptoms, which was used as the primary outcome measure. Scores reported here are differences between individuals follow up scores (e.g. 3-month post-treatment) minus their baseline CAPS scores, such that negative numbers represent reductions in CAPS scores (or improvement) over time.|3-month Post-treatment|||units on a scale||Standard Error|Mean
792242|NCT00879255|Primary|Clinician Administered PTSD Scale, for DSM-IV (CAPS IV)|The CAPS is a 30-item interview measure that assesses the frequency and intensity of PTSD symptoms during the past month and the impact these symptoms have had on social and occupational functioning. The CAPS also provides a global scale score of PTSD severity (range 0 - 136) with higher scores indicating worse symptoms, which was used as the primary outcome measure. Scores reported here are differences between individuals follow up scores (e.g. post-treatment CAPS score assessed at two-weeks following end of treatment) minus their baseline CAPS scores, such that negative numbers represent reductions in CAPS scores (or improvement) over time.|Post-treatment (two-weeks following end of treatment)|||units on a scale||Standard Error|Mean
792243|NCT00879333|Secondary|Everolimus Steady State Concentraions at Predose (Cmin) and Cmax by Region Asia vs. Rest of the World (ROW) at Week 5|Cmin is the minimum (trough) steady-state drug concentration in the blood during multiple dosing and Cmax is the maximum (peak) blood drug concentration after dose administration. Cmax is estimated as the maximum of C1h and C2H. C1h is 1 hour post-dose blood concentration and C2h is 2 hour post-dose blood concentration. Only valid pre-dose (Cmin), C1h, and C2h everolimus samples were included in the analysis. Valid pre-dose samples were confirmed blood samples collected at steady-state, collected immediately prior to dosing on the same study day, and collected at approximately 24 ± 4 hours after the previous dose and with no vomiting within the first 4 hours following the last dose. Valid C1h and C2h samples were confirmed blood samples collected at steady-state and within ± 1 hour window and with no vomiting within the first 4 hours following the current and previous dose.|Week 5|PK analyses were based on the safety population in patients with evaluable samples. Only valid pre-dose (Cmin) & Cmax everolimus samples were included. For patients who were unable to tolerate the protocol-specified dosing schedule, dose adjustments were allowed to keep the patient on study drug. Some patients had dose reductions to 5mg daily.||ng/mL||Standard Deviation|Mean
792244|NCT00879333|Secondary|Everolimus Steady State Concentraions at Predose (Cmin) and Cmax at Week 5|Cmin is the minimum (trough) steady-state drug concentration in the blood during multiple dosing and Cmax is the maximum (peak) blood drug concentration after dose administration. Cmax is estimated as the maximum of C1h and C2H. C1h is 1 hour post-dose blood concentration and C2h is 2 hour post-dose blood concentration. Only valid pre-dose (Cmin), C1h, and C2h everolimus samples were included in the analysis. Valid pre-dose samples were confirmed blood samples collected at steady-state, collected immediately prior to dosing on the same study day, and collected at approximately 24 ± 4 hours after the previous dose and with no vomiting within the first 4 hours following the last dose. Valid C1h and C2h samples were confirmed blood samples collected at steady-state and within ± 1 hour window and with no vomiting within the first 4 hours following the current and previous dose.|Week 5|PK analyses were based on the safety population in patients with evaluable samples. Only valid pre-dose (Cmin) & Cmax everolimus samples were included. For patients who were unable to tolerate the protocol-specified dosing schedule, dose adjustments were allowed to keep the patient on study drug. Some patients had dose reductions to 5mg daily.||ng/mL||Standard Deviation|Mean
792245|NCT00879333|Secondary|Overall Response Rate (ORR)|ORR was defined as the proportion of patients with measurable disease in whom best overall response (OR) was either complete response (CR) or partial response (PR) according to RECIST criteria.|2.5 years|The Full Analysis Set (FAS) consists of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment and stratum that they were assigned to at randomization.||Participants|||Number
792246|NCT00879333|Secondary|Time to Definitive Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score|The ECOG PS scale was used to classify patients according to their functional impairment, with scores ranging from 0 (fully active) to 5 (dead). An analysis of the time to definitive deterioration of the ECOG PS by one category of the score from baseline was performed. Definitive deterioration was defined as a definitive increase by one category from baseline in ECOG PS, with no later improvements observed during the course of the study. A single measure reporting an increase in ECOG PS is sufficient to consider it as a definitive worsening only if it was the last one available for the patient. Kaplan-Meier method was used to estimate the distribution function of time to definitive worsening.|2.5 years|The Full Analysis Set (FAS) consists of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment and stratum that they were assigned to at randomization.||Months||95% Confidence Interval|Median
792247|NCT00879333|Secondary|Patient Reported Outcome (PRO): Time to Definitive Deterioration of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30 (EORTC QLQ-C30) Scores|The EORTC QLQ-C30 global health status/quality of life sub-scale (QL) was pre-specified as the primary domain of interest, followed by physical functioning (PF), social functioning (SF) and emotional functioning (EF).The EORTC QLQ-C30 questionnaire, along with a module specific for gastric cancer patients (EORTC QLQ-STO22), was used to evaluate PRO. The QLQ-C30 has five function scales (physical, role, cognitive, emotional and social), three symptom scales (fatigue, pain and nausea/vomiting) and a global health status/quality of life scale. In addition, there are questions that assess specific symptoms. The QLQ-STO22 consists of 22 questions that make up five multi-item scales (dysphagia, pain, reflux, eating and anxiety) and four single-item scales (dry mouth, tasting, body image and hair loss).|2.5 years|The Full Analysis Set (FAS) consists of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment and stratum that they were assigned to at randomization.||Months||95% Confidence Interval|Median
792248|NCT00879333|Secondary|Progression Free Survival (PFS)|Progression free survival was defined as the time from the date of randomization to the date of the first documented disease progression or death due to any cause, where progression was based on Investigator assessment of baseline and post-baseline scans according to RECIST. Progression free survival was censored if no PFS event was observed before the first to occur out of (i) the cut-off date, or (ii) the date when a further anticancer therapy was started. The censoring date was the date of the last adequate tumor assessment before either of these two events occurred. If a PFS event was observed after two or more missing or non-evaluable tumor assessments, then the date of progression was censored at the date of the last adequate tumor assessment; for a PFS event observed after a single missing or non-evaluable tumor assessment, the actual date of disease progression was used. Anslsis was done using Kaplan-Meier estimates method.|2.5 years|The Full Analysis Set (FAS) consists of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment and stratum that they were assigned to at randomization.||Months||95% Confidence Interval|Median
792249|NCT00879333|Primary|Overall Survival (OS)|The primary objective of this study was to compare OS between everolimus + best supportive care (BSC) and placebo + BSC. OS, was defined as the time from date of randomization to the date of death due to any cause. If at the analysis cut-off date a patient was not known to have died, survival was censored at the date of the last contact. OS was analyzed using the Kaplan Meier estimates method.|2.5 years|The Full Analysis Set (FAS) consists of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment and stratum that they were assigned to at randomization.||Months||95% Confidence Interval|Median
792250|NCT00879359|Secondary|Number of Participants With Adverse Events Grades 1-5|Toxicity and safety was monitored before every treatment cycle, during, and after treatment. Bevacizumab was discontinued if the following criteria was met: grade 4 hypertension, reversible posterior leukoencephalopathy syndrome or hypertensive encephalopathy, grade 4 nephritic syndrome, arterial thrombosis, symptomatic grade 4 or recurrent/worsening venous thromboembolic events after resumption of bevacizumab treatment, grade 3 hemorrhage, bowel perforation or fistula and any complete wound disruption.|58 months|||participants|||Number
792251|NCT00879359|Secondary|Median Progression Free Survival of This Treatment Regimen in Patients With Advanced/Recurrent Endometrial Cancer.|Median progression free survival measured in months. Progression of disease is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST version 1.0), as a 20% increased in the sum of the longest diameter of the target lesions, or a measurable increased in a non-target lesion, or the appearance of a new lesion.|58 months|||months||Full Range|Median
792390|NCT00891982|Primary|Local Tolerability - Skin Scaling|"Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:
0 - None
- Trace
- Mild
- Moderate
- Marked
- Severe"|Week 2|||Participants|||Number
792252|NCT00879359|Primary|Number of Participants With Progression Free Survival (PFS=Date of Progression of Disease or Death) at 6 Months Using Bevacizumab, Carboplatin, and Paclitaxel in Patients With Measurable Disease for Advanced/Recurrent Endometrial Cancer|Number of patients with progression free survival measured at 6 months. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST version 1.0), as a 20% increased in the sum of the longest diameter of target lesions, or a measure increase in a non-target lesion, or the appearance of new lesions.|58 months|||Participants|||Count of Participants
792253|NCT00884754|Primary|Time to Intubation (Seconds)||30-150 seconds (anticipated)|||seconds||Inter-Quartile Range|Median
792254|NCT00884793|Secondary|"Average Change in Activated (CD38+HLADR+) CD8+ T Cells in the Ileum"|Average of changes(week 0-week 12) in the % of CD8+ T cells that are CD38+HLA-DR+, by flow cytometry|12 weeks|All patients who had endoscopy at week 12.||percentage change||Standard Error|Mean
792255|NCT00884793|Secondary|Number of Subjects Who Experienced an Increase in CD4% in the Ileum.|Number of subjects who experienced an increase from week 0 to week 12 in CD4+ T cells (as a % of T cells, by flow cytometry) in the ileum|12 weeks|Includes all those who had endoscopy at week 12||participants|||Number
792256|NCT00884793|Secondary|Number of Subjects Who Experienced an Increase in CD4+ T Cells (as a % of All Cells) in the Ileum.|Number of subjects who experienced an increase in CD4+ T cells (as a % of all cells) in the ileum (by flow cytometry) from week 0 to week 12.|12 weeks|Includes all with gut samples from week 12.||participants|||Number
792257|NCT00884793|Primary|Number of Subjects Who Had a Decrease in HIV RNA Per Million CD4+ T Cells in the Ileum|Number of subjects who had a decrease from week 0 to week 12 in unspliced cell-associated HIV RNA per million CD4+ T cells in the ileum|12 weeks|We analyzed data from all subjects who had endosocopies at week 12.||participants|||Number
792258|NCT00884806|Secondary|Mean Lens Comfort|"Lens comfort was assessed by the participant on a 5-point Likert scale prior to any examination. The participant was instructed to select a single response to the statement, Over the previous 2-3 hours, my lenses felt comfortable, with 1 = strongly disagree, 2 = disagree, 3 = undecided, 4 = agree, and 5 = strongly agree."|Day 7|Intent to treat: All participant who received regimen and had at least one on-therapy study visit.||Units on a scale||Standard Deviation|Mean
792259|NCT00884806|Primary|Solution-Related Corneal Staining|Corneal staining was assessed by the investigator using fluorescein dye, a yellow filter, and a slit lamp. Corneal staining was graded on a continuous scale of 0% (no staining in the region) to 100% (staining covers entire region) in 1% increments for 5 corneal regions (central, nasal, temporal, inferior, and superior). Solution-related corneal staining was defined as ≥20% corneal staining area in at least 3 corneal regions of both eyes.|Day 7|Intent to treat: All participants who received regimen and had at least one on-therapy visit.||Percentage of participants|||Number
792260|NCT00891046|Secondary|Change From Baseline in Growth Velocity Parameter for BMI to Last Assessment of Study|Growth velocity parameter BMI percentile was determined. Percentile was based on the growth charts smoothed percentile curve released by Centers for Disease control and prevention (CDC) in 2000, by sex and age.|Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier|The analysis was performed in FAS population. Here, 'Number of participants analyzed' signifies those participants with a value at both baseline and the respective post baseline time point.||Percentile||Full Range|Median
792261|NCT00891046|Secondary|Change From Baseline in Growth Velocity Parameters to Last Assessment of Study|Growth velocity parameter weight percentile was determined. Percentile was based on the growth charts smoothed percentile curve released by Centers for Disease control and prevention (CDC) in 2000, by sex and age.|Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier|The analysis was performed in FAS population. Here, 'Number of participants analyzed' signifies those participants with a value at both baseline and the respective post baseline time point.||Percentile||Full Range|Median
792262|NCT00891046|Secondary|Percentage of Participants With Inactive Disease|Inactive disease was defined as no joints with active arthritis; no fever (body temperature ≤ 38 degree Celsius); no rheumatoid rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to SJIA; normal CRP, and a rating of no disease activity on the Physician’s Global Assessment of disease activity (with a best possible score ≤10 mm on the VAS).|Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier|The analysis was performed in FAS population. Here 'Number of participants analysed' signifies number of participants with an assessment in the given visit.||Percentage of participants|||Number
792263|NCT00891046|Secondary|Change From Baseline in Growth Velocity Parameter for Height to Last Assessment of Study|Growth velocity parameter height percentile was determined. Percentile was based on the growth charts smoothed percentile curve released by Centers for Disease control and prevention (CDC) in 2000, by sex and age.|Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier|The analysis was performed in FAS population. Here, 'Number of participants analyzed' signifies those participants with a value at both baseline and the respective post baseline time point.||Percentile||Full Range|Median
792264|NCT00891046|Secondary|Change From Baseline in Pediatric Daytime Sleepiness Scale (PDSS) Score to Last Assessment of Study|Sleep patterns in children and adolescents aged between 11 and 15 years were determined using PDSS instrument to evaluate whether canakinumab helps in reducing sleepiness in children with SJIA. Participants were assessed on 8 items of PDSS, on a scale of 0 to 4 (0 - never, 1 - seldom, 2- sometimes, 3 - frequently and 4 - always). The sum of all the items was reported as total score with a range of 0-32. Change from baseline was calculated by using the formula = (post baseline value - baseline value). A positive change from baseline score indicated improvement.|Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier|The analysis was performed in FAS population. Here, ‘Number of participants analysed’ signifies those participants with a value at both baseline and the respective post baseline time point and with an assessment of PDSS score in the given visit..||units on a scale||Full Range|Median
792293|NCT00891176|Secondary|Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values|Cut-off values assessed were defined as equal to or above 10 milli-international units per milliliter (mIU/mL) or equal to or above 100 mIU/mL.|At 4 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 4 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 4 years of age||Subjects|||Number
792265|NCT00891046|Secondary|Change From Baseline in EuroQual 5 ­Dimension Health Status Questionnaire (EQ­5D) Utility Index and Health State Assessment Scores [EQ Visual Analog Scale (EQ-VAS)] to Last Assessment of Study|EQ­5D HRQoL tool was employed for participants above 12 years and EQ­5D proxy for 8 – 11 years. Utility based EQ­5D questionnaire was in two parts and provides generic measure of health for clinical and economic appraisal based on 2 parts: EQ-5D descriptive system and EQ-VAS. EQ-5D descriptive system contains 5 dimensions each with 3 levels (Level 1: no problem, Level 2: moderate problem, Level 3: severe problem): mobility (1=0, 2=0.069, 3=0.314), self care (1=0, 2=0.104, 3=0.214), usual activities (1=0, 2=0.036, 3=0.094), pain/discomfort (1=0, 2=0, 3=0.386) and anxiety/depression (1=0, 2=0.071, 3=0.2). EQ-5D Total score= 1 - 0.081 - (score of level 2 in present) - 0.269 (if at least one of level 3 presents). EQ-5D total score: 1 = high quality of life; -0.59 worst quality of life. EQ-VAS recorded participant's self-rated health on vertical, visual analog scale- '100': Best and ‘0': Worst imaginable health state. A positive change from baseline score indicated improved health status.|Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier|The analysis was performed in FAS population. Here 'Number of participants analysed' signifies number of participants with EQ­5D assessment in the given visit.||units on a scale||Full Range|Median
792266|NCT00891046|Secondary|Change From Baseline in Health­Related Quality of Life (HRQoL) Over Time Based on Child Health Questionnaire­ Parent Form (CHQ­PF50) to Last Assessment of Study|The Child Health Questionnaire – Parent Form (CHQ­PF50) instrument was used to measure HRQoL aged 5 to 18 years from a parent’s perspective. This 14 concept questionnaire measured physical and psychosocial health of the participants on following points: physical functioning, role/social emotional, role/social behavior, role/social physical, bodily pain, general behavior, mental health, self-esteem, general health perception, change in health, parental impact ­ emotional, parental impact – time, family activities, and family cohesion. Total score ranged from 1-100. Increase in score represented improvement in overall well being of participants. Change from baseline was calculated by using the formula = (post baseline value – baseline value).|Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier|The analysis was performed in FAS population. Here 'Number of participants analysed' signifies number of participants with HRQoL assessment in the given visit.||units on a scale||Full Range|Median
792267|NCT00891046|Secondary|Change From Baseline in Disability, Overall Well­Being and Pain Intensity Scores Based on Child Health Assessment Questionnaire (CHAQ) to Last Assessment of Study|The CHAQ was used to assess physical ability, overall well- being and pain intensity experienced by participants. The CHAQ (disability and well-being) dimension consisted of 20 multiple choice items concerning difficulty in performing eight common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and other “activities”. Participants were graded for the response in four categories, ranging from 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty) and 3 (unable to do). Participant’s pain intensity was assessed by parents and adult participants (18­20 years old) on a VAS scale of 0-100 mm (0 mm: no pain to 100: very severe pain). Change from baseline was calculated by using the formula = (post baseline value – baseline value). For both scales, lower scores indicate increased functional ability.|Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier|The analysis was performed in FAS population.||units on a scale||Full Range|Median
792268|NCT00891046|Secondary|Percentage of Participants With Clinical Remission|Clinical remission was defined as at least 6 months of inactive disease or at least 12 months of inactive disease on medication during the extension period. Participants with inactive disease for at least 6 months, but had loss of inactive disease before 12 months were also determined.|Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier|The analysis was done in FAS population. Here 'Number of participants analysed' signifies number of participants with an assessment in the given visit.||Percentage of participants|||Number
792269|NCT00891046|Secondary|Number of Participants Who Reduced Their Canakinumab Dose to 2 mg/kg|The canakinumab dose could be reduced from 4 mg/kg to 2 mg/kg in participants who were steroid-free, if requested by the treating physician and agreed by the sponsor. For treatment naive participants , dose reduction was allowed after the participant had received 6 months treatment with canakinumab.|Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier|The analysis was done in FAS population.||participants|||Number
792270|NCT00891046|Secondary|Percentage of Participants Able to Taper Oral Steroid Use or Reached Steroid Free Regimen|Steroid tapering with oral steroids was allowed if the participant achieved an adapted ACR Paediatric 50 response and had no fever. A participant was considered to have tapered steroids successfully, if the steroid dose was reduced from baseline and the participant did not flare and maintained a minimum adapted ACR Paediatric 30 at the last measurement. A participant was considered to have unsuccessfully tapered steroids if the steroid dose was reduced during the study but dose at last assessment was equal to or greater than dose at baseline or; if steroid dose was reduced but the participant did not maintain a minimum adapted ACR Paediatric 30 at the last measurement.|Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier|The analysis was done in FAS population. Here 'Number of participants analysed' signifies number of participants who were steroid users at baseline.||Percentage of participants|||Number
792271|NCT00891046|Secondary|Percentage of Participants With Minimum Adapted ACR Pediatric ≥ 30 at Baseline Who Achieved Minimum Response of ACR Pediatric 30/50/70/90/100 at Last Assessment of Study|Adapted ACR Paediatric 30/50/70/90 or 100 was assessed based on following 7 variables: 1.Physician’s Global Assessment on a 0-100 mm VAS; 2. Participants Global Assessment on a 0-100 mm VAS; 3. Functional ability; 4. Joints count with active arthritis; 5. Joints count with limitation of motion; 6. Laboratory measure of CRP and 7. Absence of intermittent fever due to SJIA during the preceding week. Response was defined as ≥ 30%/50%/70%/90% or 100% improvement in at least 3 of the response variables 1 to 6, no intermittent fever in the preceding week (variable 7) and with no more than one variable 1 to 6 worsening by more than 30%. For minimum adapted ACR paediatric scores, the last measurement recorded from the participant's previous study was considered baseline for the current study.|Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier|The analysis was done in FAS population. Here 'Number of participants analysed' signifies number of participants with an ACR assessment at the given visit.||Percentage of participants|||Number
792424|NCT00892099|Secondary|Infectious Hospitalizations and Mortality||1 year||||||
792425|NCT00892099|Secondary|All Cause Hospitalizations and Mortality||1 year||||||
792272|NCT00891046|Secondary|Percentage of Non-­Responders Who Achieved Minimum Response of American College of Rheumatology (ACR) Pediatric 30/50/70/90/100|Adapted ACR Paediatric 30/50/70/90 or 100 was assessed based on following 7 variables: 1.Physician’s Global Assessment on a 0-100 mm VAS; 2. Participants Global Assessment on a 0-100 mm VAS; 3. Functional ability; 4. Joints count with active arthritis; 5. Joints count with limitation of motion; 6. Laboratory measure of ­CRP and 7. Absence of intermittent fever due to SJIA during the preceding week. Response was defined as ≥ 30%/50%/70%/90% or 100% improvement in at least 3 of the response variables 1 to 6, no intermittent fever (i.e. body temperature ≤ 38°C) in the preceding week (variable 7) and with no more than one variable 1 to 6, worsening by more than 30%.|Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier|The analysis was done in FAS population. Here 'Number of participants analysed' signifies number of participants with an ACR assessment at the given visit. For arm 'ACZ885 treated: Group 2 (Completed core study)' there were no Non-Responders participants available.||Percentage of participants|||Number
792273|NCT00891046|Primary|Percentage of Participants Previously Treated With Other Biologics Who Achieved Minimum Response of American College of Rheumatology (ACR) Pediatric 30/50/70/90/100 at Last Assessment of Study|Adapted ACR Paediatric 30/50/70/90 or 100 was assessed based on following 7 variables: 1.Physician's Global Assessment on a 0­100 mm VAS; 2. Participants Global Assessment on a 0­100 mm VAS; 3. Functional ability; 4. Joints count with active arthritis; 5. Joints count with limitation of motion; 6. Laboratory measure of CRP and 7. Absence of intermittent fever due to SJIA during the preceding week. Response was defined as ≥ 30%/50%/70%/90% or 100% improvement in at least 3 of the response variables 1 to 6, no intermittent fever (i.e. body temperature ≤ 38 °C) in the preceding week (variable 7) and with no more than one variable 1 to 6, worsening by more than 30%.|Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier|The analysis was done in FAS population. Here 'Number of participants analyzed’ signifies number of participants with an ACR assessment at the given visit. For arm 'ACZ885 treatment naive: Group 2' there were no participants who had discontinued other biologics due to safety/tolerability issues.||Percentage of participants|||Number
792274|NCT00891046|Primary|Percentage of Participants Previously Treated With Tocilizumab Who Achieved Minimum Response of American College of Rheumatology (ACR) Pediatric 30/50/70/90/100 at Last Assessment of Study|Adapted ACR Paediatric 30/50/70/90 or 100 was assessed based on following 7 variables: 1.Physician's Global Assessment on a 0­100 mm VAS; 2. Participants Global Assessment on a 0­100 mm VAS; 3. Functional ability; 4. Joints count with active arthritis; 5. Joints count with limitation of motion; 6. Laboratory measure of CRP and 7. Absence of intermittent fever due to SJIA during the preceding week. Response was defined as ≥ 30%/50%/70%/90% or 100% improvement in at least 3 of the response variables 1 to 6, no intermittent fever (i.e. body temperature ≤ 38 °C) in the preceding week (variable 7) and with no more than one variable 1 to 6, worsening by more than 30%.|Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier|The analysis was done in FAS population. Here 'Number of participants analyzed’ signifies number of participants with an ACR assessment at the given visit.||Percentage of participants|||Number
792275|NCT00891046|Primary|Percentage of Participants Previously Treated With Anakinra Who Achieved Minimum Response of American College of Rheumatology (ACR) Pediatric 30/50/70/90/100 at Last Assessment of Study|Adapted ACR Paediatric 30/50/70/90 or 100 was assessed based on following 7 variables: 1.Physician's Global Assessment on a 1-100 millimeter (mm) visual analog scale (VAS); 2. Participants Global Assessment on a 1-100 mm VAS; 3. Functional ability; 4. Joints count with active arthritis; 5. Joints count with limitation of motion; 6. Laboratory measure of C-reactive protein (CRP) and 7. Absence of intermittent fever due to severe juvenile idiopathic arthritis (SJIA) during the preceding week. Response was defined as more than or equal to (≥) 30%/50%/70%/90% or 100% improvement in at least 3 of the response variables 1 to 6, no intermittent fever (i.e. body temperature less than or equal to (≤) 38 °C) in the preceding week (variable 7) and with no more than one variable 1 to 6, worsening by more than 30%.|Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier|The analysis was done in FAS population. Here 'Number of participants analyzed’ signifies number of participants with an ACR assessment at the given visit.||Percentage of participants|||Number
792276|NCT00891046|Primary|Number of Participants With Clinically Significant Local Injection Site Reactions During the Study|Local injection site tolerability was assessed on the injection site. Each participant was classified into one of the following four categories: 1. no tolerability reactions at any time during the study, 2. mild reaction observed on at least one occasion but no moderate or severe reactions. 3. moderate reaction observed on at least one occasion but no severe reaction. 4. severe reaction observed on at least one occasion.|From start of study treatment (Day 1) up to end of follow-up period (Week 271 for ACZ885 treated participants and Week 145 for ACZ885 treatment naive participants)|The analysis was performed in SS population.||participants|||Number
792277|NCT00891046|Primary|Number of Participants With Anti -ACZ885 Antibodies at Any Visit During the Study|Immunogenicity assessment included determination of anti­canakinumab (ACZ885) antibodies in serum samples using BIAcore system.|From start of study treatment (Day 1) up to end of follow-up period (Week 271 for ACZ885 treated participants and Week 145 for ACZ885 treatment naive participants)|The analysis was performed on the SS population.||participants|||Number
792278|NCT00891046|Primary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs by Severity, AEs Leading to Discontinuation, SAEs Leading to Discontinuation, Treatment Related AEs and SAE|An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. A SAE was defined as an event which was fatal or life threatening, required or prolonged hospitalization, was significantly or permanently disabling or incapacitating, constituted a congenital anomaly or a birth defect, or encompassed any other clinically significant event that could jeopardize the participants or require medical or surgical intervention to prevent one of the aforementioned outcomes. Treatment related AEs or SAEs were defined as AEs or SAEs that were suspected to be related to study treatment as per investigator.|From start of study treatment (Day 1) up to end of follow-up period (Week 271 for ACZ885 treated participants and Week 145 for ACZ885 treatment naive participants)|The analysis was performed in safety set (SS), defined as all participants who received at least one dose of study drug.||participants|||Number
792319|NCT00891202|Secondary|PAP: Hemoglobin Level||PAP Baseline (Day 1)|FAS for PAP included all participants who signed informed consent and received at least one dose of study drug (placebo or eliglustat).||gram per deciliter (g/dL)||Standard Deviation|Mean
792279|NCT00891176|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related = SAE assessed by the investigator as being related to the study procedures.|From last study contact of the study (NCT00463437) at 17-24 months of age until 6 years of age|Analysis was performed on the Total Enrolled cohort at 6 years of age, which included all subjects vaccinated in the booster study (NCT00463437) and who were part of the blood sample subset.||Subjects|||Number
792280|NCT00891176|Secondary|Anti-HBs Antibody Concentrations||At 6 years of age||12/2014||||
792281|NCT00891176|Secondary|Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values||At 6 years of age||12/2014||||
792282|NCT00891176|Secondary|Concentration of Antibodies Against Protein D|Concentrations were expressed as GMCs in enzyme-linked immunosorbent-assay (ELISA) units per milliliter (EL.U/mL).|At 6 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 6 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 6 years of age.||EL.U/mL||95% Confidence Interval|Geometric Mean
792283|NCT00891176|Secondary|Number of Subjects With Opsonophagocytic Activity|Opsonophagocytic activity was measured by a killing-assay. The results were presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay was an opsonic titer of 8.|At 6 years of age||12/2014||||
792284|NCT00891176|Secondary|Antibody Concentrations Against Vaccine Pneumococcal Serotypes|Antibody concentrations were expressed as GMCs in μg/mL. Vaccine pneumococcal serotypes assessed included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.|At 6 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 6 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 6 years of age.||μg/mL||95% Confidence Interval|Geometric Mean
792285|NCT00891176|Secondary|Anti-PRP Concentrations|Concentrations were defined as Geometric Mean Concentrations (GMCs) in μg/mL|At 6 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 6 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 6 years of age.||μg/mL||95% Confidence Interval|Geometric Mean
792286|NCT00891176|Secondary|Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations Equal to or Above Cut-off Values|The cut-off values were defined as a concentration ≥ 0.15 microgram per milliliter (μg/mL) and ≥ 1.0 μg/mL.|At 6 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 6 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 6 years of age.||Subjects|||Number
792287|NCT00891176|Secondary|rSBA-MenC Titers|Titers are given as Geometric Mean Titers (GMTs).|At 6 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 6 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 6 years of age||Titer||95% Confidence Interval|Geometric Mean
792288|NCT00891176|Secondary|Number of Subjects With rSBA-MenC Titer Equal to or Above Cut-off Value|rSBA-MenC antibody cut-off value assessed was equal to or above 1:128.|At 6 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 6 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 6 years of age.||Subjects|||Number
792289|NCT00891176|Primary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Titers Using Rabbit Complement (rSBA-MenC) Equal to or Above Cut-off Value|rSBA-MenC antibody cut-off value assessed was equal to or above 1:8. The rSBA-MenC assay was performed at the Public Health England (PHE) laboratory at 6 years of age while the GSK laboratory was used for testing at 3 and 4 years of age.|At 4 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 4 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 4 years of age.||Subjects|||Number
792290|NCT00891176|Primary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Titers Using Rabbit Complement (rSBA-MenC) Equal to or Above Cut-off Value|rSBA-MenC antibody cut-off value assessed was equal to or above 1:8. The rSBA-MenC assay was performed at the Public Health England (PHE) laboratory at 6 years of age while the GSK laboratory was used for testing at 3 and 4 years of age.|At 6 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 6 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 6 years of age.||Subjects|||Number
792291|NCT00891176|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related = SAE assessed by the investigator as being related to the study procedures.|From last study contact of the study (NCT00463437) at 17-24 months of age until 4 years of age|Analysis was performed on the Total Enrolled cohort at 4 years of age, which included all subjects vaccinated in the booster study (NCT00463437) and who were part of the blood sample subset.||Subjects|||Number
792292|NCT00891176|Secondary|Anti-HBs Antibody Concentrations|Concentrations were expressed as GMCs in mIU/mL.|At 4 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 4 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 4 years of age||mIU/mL||95% Confidence Interval|Geometric Mean
792426|NCT00892099|Secondary|Plasma Cathelicidin||every 4 weeks for 12 weeks||||||
792427|NCT00892099|Secondary|Serum 1,25-dihydroxyvitamin D Levels||every 4 weeks for 12 weeks||||||
792294|NCT00891176|Secondary|Concentration of Antibodies Against Protein D|Concentrations were expressed as GMCs in enzyme-linked immunosorbent-assay (ELISA) units per milliliter (EL.U/mL).|At 4 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 4 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 4 years of age||EL.U/mL||95% Confidence Interval|Geometric Mean
792295|NCT00891176|Secondary|Number of Subjects With Opsonophagocytic Activity|Opsonophagocytic activity was measured by a killing-assay. The results were presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay was an opsonic titer of 8.|At 4 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 4 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 4 years of age||Subjects|||Number
792296|NCT00891176|Secondary|Antibody Concentrations Against Vaccine Pneumococcal Serotypes|Antibody concentrations were expressed as GMCs in μg/mL. Vaccine pneumococcal serotypes assessed included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.|At 4 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 4 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 4 years of age||μg/mL||95% Confidence Interval|Geometric Mean
792297|NCT00891176|Secondary|Anti-PRP Concentrations|Concentrations were defined as Geometric Mean Concentrations (GMCs) in μg/mL|At 4 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 4 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 4 years of age||μg/mL||95% Confidence Interval|Geometric Mean
792298|NCT00891176|Secondary|Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations Equal to or Above Cut-off Values|The cut-off values were defined as a concentration equal to or above 0.15 microgram per milliliter (μg/mL) and equal to or above 1.0 μg/mL.|At 4 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 4 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 4 years of age||Subjects|||Number
792299|NCT00891176|Secondary|Number of Subjects With an rSBA-MenC Titer Equal to or Above Cut-off Value|rSBA-MenC antibody cut-off value assessed was equal to or above 1:128.|At 4 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 4 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 4 years of age||Subjects|||Number
792300|NCT00891176|Secondary|rSBA-MenC Titers|Titers are given as Geometric Mean Titers (GMTs).|At 4 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 4 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 4 years of age||Titers||95% Confidence Interval|Geometric Mean
792301|NCT00891176|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related = SAE assessed by the investigator as being related to the study procedures.|From last study contact of the study (NCT00463437) at 17-24 months of age until 3 years of age|Analysis was performed on the Total Enrolled cohort at 3 years of age, which included all subjects vaccinated in the booster study (NCT00463437) and who were part of the blood sample subset.||subjects|||Number
792302|NCT00891176|Secondary|Anti-HBs Antibody Concentrations|Concentrations were expressed as GMCs in mIU/mL.|At 3 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 3 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 3 years of age||mIU/mL||95% Confidence Interval|Geometric Mean
792303|NCT00891176|Secondary|Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values|Cut-off values assessed were defined as equal to or above 10 milli-international units per milliliter (mIU/mL) or equal to or above 100 mIU/mL.|At 3 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 3 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 3 years of age||subjects|||Number
792304|NCT00891176|Secondary|Concentration of Antibodies Against Protein D|Concentrations were expressed as GMCs in enzyme-linked immunosorbent-assay (ELISA) units per milliliter (EL.U/mL).|At 3 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 3 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 3 years of age||EL.U/mL||95% Confidence Interval|Geometric Mean
792305|NCT00891176|Secondary|Number of Subjects With Opsonophagocytic Activity|Opsonophagocytic activity was measured by a killing-assay. The results were presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay was an opsonic titre of 8.|At 3 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 3 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 3 years of age||Subjects|||Number
792306|NCT00891176|Secondary|Antibody Concentrations Against Vaccine Pneumococcal Serotypes|"Antibody concentrations were expressed as GMCs in μg/mL.
Vaccine pneumococcal serotypes assessed included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F."|At 3 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 3 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 3 years of age.||μg/mL||95% Confidence Interval|Geometric Mean
792307|NCT00891176|Secondary|Anti-PRP Concentrations|Concentrations were defined as Geometric Mean Concentrations (GMCs) in μg/mL,|At 3 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 3 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 3 years of age.||μg/mL||95% Confidence Interval|Geometric Mean
792308|NCT00891176|Secondary|Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations Equal to or Above Cut-off Values|The cut-off values were defined as a concentration equal to or above 0.15 microgram per milliliter (μg/mL) and equal to or above 1.0 μg/mL.|At 3 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 3 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 3 years of age.||subjects|||Number
792309|NCT00891176|Secondary|rSBA-MenC Titers|Titers are given as Geometric Mean Titers (GMTs).|At 3 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 3 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 3 years of age.||Titer||95% Confidence Interval|Geometric Mean
792310|NCT00891176|Secondary|Number of Subjects With an rSBA-MenC Titer Equal to or Above Cut-off Value|The cut-off value was defined as a titer equal to or above 1:128.|At 3 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 3 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 3 years of age.||subjects|||Number
792311|NCT00891176|Primary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Titers Using Rabbit Complement (rSBA-MenC) Equal to or Above Cut-off Value|rSBA-MenC antibody cut-off value assessed was equal to or above 1:8. The rSBA-MenC assay was performed at the Public Health England (PHE) laboratory at 6 years of age while the GSK laboratory was used for testing at 3 and 4 years of age.|At 3 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 3 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 3 years of age.||subjects|||Number
792312|NCT00891202|Secondary|LTTP: Percent Change From Baseline in Platelet Counts at Week 234|Percent change in platelet count = ([platelet count at Week 234 minus platelet count at baseline] divided by [platelet count at baseline]) multiplied by 100. Baseline values for the original placebo participants refer to Day 1 of LTTP and baseline values for the original eliglustat participants refer to the Day 1 of PAP.|PAP Baseline for Eliglustat (Originally on Eliglustat) arm, LTTP Baseline for Eliglustat (Originally on Placebo) arm, Week 234|ITT population for LTTP included all participants who received at least 1 dose of eliglustat in LTTP period. Number of participants analyzed=participants evaluable for this outcome measure and had available data for baseline and Week 234 platelet count assessment.||percent change||Standard Deviation|Mean
792313|NCT00891202|Secondary|LTTP: Percent Change From Baseline in Liver Volume (in MN) at Week 234|Percent change in liver volume = ([liver volume at Week 234 minus liver volume at baseline] divided by [liver volume at baseline]) multiplied by 100, where all volumes are in MN. Baseline values for the original placebo participants refer to Day 1 of LTTP and baseline values for the original eliglustat participants refer to the Day 1 of PAP.|PAP Baseline for Eliglustat (Originally on Eliglustat) arm, LTTP Baseline for Eliglustat (Originally on Placebo) arm, Week 234|ITT population for LTTP included all participants who received at least 1 dose of eliglustat in LTTP period. Number of participants analyzed=participants evaluable for this outcome measure and had available data for baseline and Week 234 liver volume assessment.||percent change||Standard Deviation|Mean
792314|NCT00891202|Secondary|LTTP: Absolute Change From Baseline in Hemoglobin Level at Week 234|Baseline values for the original placebo participants refer to Day 1 of LTTP and baseline values for the original eliglustat participants refer to the Day 1 of PAP.|PAP Baseline for Eliglustat (Originally on Eliglustat) arm, LTTP Baseline for Eliglustat (Originally on Placebo) arm, Week 234|ITT population for LTTP included all participants who received at least 1 dose of eliglustat in LTTP period. Number of participants analyzed=participants evaluable for this outcome measure and had available data for baseline and Week 234 hemoglobin level assessment.||g/dL||Standard Deviation|Mean
792315|NCT00891202|Secondary|LTTP: Percent Change From Baseline in Spleen Volume (in MN) at Week 234|Percent change in spleen volume = ([spleen volume at Week 234 minus spleen volume at baseline] divided by [spleen volume at baseline]) multiplied by 100, where all volumes are in MN. Baseline values for the original placebo participants refer to Day 1 of LTTP and baseline values for the original eliglustat participants refer to the Day 1 of PAP.|PAP Baseline for Eliglustat (Originally on Eliglustat) arm, LTTP Baseline for Eliglustat (Originally on Placebo) arm, Week 234|Intent-to-treat (ITT) population for LTTP included all participants who received at least 1 dose of eliglustat in LTTP period. Number of participants analyzed= participants evaluable for this outcome measure and had available data for baseline and Week 234 spleen volume assessment.||percent change||Standard Deviation|Mean
792316|NCT00891202|Secondary|PAP: Percent Change From Baseline in Platelet Counts at Week 39|Percent change in platelet count = ([platelet count at Week 39 minus platelet count at baseline] divided by [platelet count at baseline]) multiplied by 100.|PAP Baseline (Day 1), Week 39|FAS for PAP included all participants who signed informed consent and received at least one dose of study drug (placebo or eliglustat).||percent change||Standard Error|Least Squares Mean
792317|NCT00891202|Secondary|PAP: Percent Change From Baseline in Liver Volume (in MN) at Week 39|Percent change in liver volume = ([liver volume at Week 39 minus liver volume at baseline] divided by [liver volume at baseline]) multiplied by 100, where all volumes are in MN.|PAP Baseline (Day 1), Week 39|FAS for PAP included all participants who signed informed consent and received at least one dose of study drug (placebo or eliglustat).||percent change||Standard Error|Least Squares Mean
792318|NCT00891202|Secondary|PAP: Absolute Change From Baseline in Hemoglobin Level at Week 39|Absolute change = hemoglobin level at Week 39 minus hemoglobin level at baseline.|PAP Baseline (Day 1), Week 39|FAS for PAP included all participants who signed informed consent and received at least one dose of study drug (placebo or eliglustat).||g/dL||Standard Error|Least Squares Mean
792428|NCT00892099|Secondary|Parathyroid Hormone||Every 4 weeks for 12 weeks||||||
792320|NCT00891202|Primary|PAP: Percent Change From Baseline in Spleen Volume (in Multiples of Normal [MN]) at Week 39 of the Primary Analysis Period With Eliglustat Tartrate Treatment as Compared to Placebo|Percent change in spleen volume = ([spleen volume at Week 39 minus spleen volume at baseline] divided by [spleen volume at baseline]) multiplied by 100, where all volumes are in MN.|PAP Baseline (Day 1), Week 39|FAS for PAP included all participants who signed informed consent and received at least one dose of study drug (placebo or eliglustat).||percent change||Standard Error|Least Squares Mean
792321|NCT00891293|Secondary|Percent Change in Non-HDL-C From LOV111859/OM5 (Double-blind [DB] Study) Baseline to Week 8 of LOV111860/OM5X (1st Open-label [OL] Extension Study) and From LOV111859/OM5 (DB Study) Baseline to Month 24 of LOV111821/OM5XX (2nd OL Extension Study)|Median Percent Change of non- high density lipoprotein-cholesterol (non-HDL-C) from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change of non-HDL-C from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.|LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24|MITT Population is defined as subjects who have a baseline assessment in Study LOV111859/OM5 and at least one on-therapy Study LOV111821/OM5XX efficacy assessment.||Percentage change||Full Range|Median
792322|NCT00891293|Secondary|Percent Change in Apo B From LOV111859/OM5 (Double-blind [DB[ Study) Baseline to Week 8 of LOV111860/OM5X (1st Open-label [OL] Extension Study) From LOV111859/OM5 (DB Study) Baseline to Month 24 of LOV111821/OM5XX (2nd OL Extension Study)|Median Percent Change in apolipoprotein (apo) B from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change of apo B from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.|LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24|MITT Population is defined as subjects who have a baseline assessment in Study LOV111859/OM5 and at least one on-therapy Study LOV111821/OM5XX efficacy assessment.||Percentage change||Full Range|Median
792323|NCT00891293|Secondary|Percent Change in Apo A-1 From LOV111859/OM5 (Double-blind [DB] Study) Baseline to Week 8 of LOV111860/OM5X (1st Open-label [OL] Extension Study) and From LOV111859/OM5 (DB Study) Baseline to Month 24 of LOV111821/OM5XX (2nd OL Extension Study|Median Percent Change in apolipoprotein (apo) A-1 from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change of apo A-1 from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.|LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24|MITT Population is defined as subjects who have a baseline assessment in Study LOV111859/OM5 and at least one on-therapy Study LOV111821/OM5XX efficacy assessment.||Percentage change||Full Range|Median
792324|NCT00891293|Secondary|Percent Change in Ratio of Total-C:HDL-C From LOV111859/OM5 (Double-blind [DB] Study) Baseline to Week 8 of LOV111860/OM5X (1st Open-label [OL] Extension Study) and From LOV111859/OM5 (DB Study) Baseline to Month 24 of LOV111821/OM5XX (2nd OL Ext. Study)|Median Percent Change in the ratio of total cholesterol (Total-C) to high density lipoprotein-cholesterol (HDL-C) from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change for the ratio of Total-C to HDL-C from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.|LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24|MITT Population is defined as subjects who have a baseline assessment in Study LOV111859/OM5 and at least one on-therapy Study LOV111821/OM5XX efficacy assessment.||Percentage change||Full Range|Median
792325|NCT00891293|Secondary|Percent Change in HDL-C From LOV111859/OM5 (Double-blind [DB] Study) Baseline to Week 8 of LOV111860/OM5X (1st Open-label [OL] Extension Study) and From LOV111859/OM5 (DB Study) Baseline to Month 24 of LOV111821/OM5XX (2nd OL Extension Study)|Median Percent Change in high density lipoprotein-cholesterol (HDL-C) from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change of HDL-C from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.|LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24|MITT Population is defined as subjects who have a baseline assessment in Study LOV111859/OM5 and at least one on-therapy Study LOV111821/OM5XX efficacy assessment.||Percentage change||Full Range|Median
792326|NCT00891293|Secondary|Percent Change in LDL-C From LOV111859/OM5 (Double-blind [DB] Study) Baseline to Week 8 of LOV111860/OM5X (1st Open-label [OL] Extension Study) and From LOV111859/OM5 (DB Study) Baseline to Month 24 of LOV111821/OM5XX (2nd OL Extension Study)|Median Percent Change in low density lipoprotein-cholesterol (LDL-C) from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change of LDL-C from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.|LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24|MITT Population is defined as subjects who have a baseline assessment in Study LOV111859/OM5 and at least one on-therapy Study LOV111821/OM5XX efficacy assessment.||Percentage change||Full Range|Median
792327|NCT00891293|Secondary|Percent Change in VLDL-C From LOV111859/OM5 (Double-blind [DB] Study) Baseline to Week 8 of LOV111860/OM5X (1st Open-label [OL] Extension Study) and From LOV111859/OM5 (DB Study) Baseline to Month 24 of LOV111821/OM5XX (2nd OL Extension Study)|Median Percent Change in very low density lipoprotein-cholesterol (VLDL-C) from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change of VLDL-C from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.|LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24|MITT Population is defined as subjects who have a baseline assessment in Study LOV111859/OM5 and at least one on-therapy Study LOV111821/OM5XX efficacy assessment.||Percentage change||Full Range|Median
792328|NCT00891293|Secondary|Percent Change in Total Cholesterol From LOV111859/OM5 (Double-blind [DB] Study) Baseline to Week 8 of LOV111860/OM5X (1st Open-label [OL] Extension Study) and From LOV111859/OM5 (DB Study) Baseline to Month 24 of LOV111821/OM5XX (2nd OL Extension Study).|Median Percent Change in Total Cholesterol (Total-C) from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change of Total-C from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.|LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24|MITT Population is defined as subjects who have a baseline assessment in Study LOV111859/OM5 and at least one on-therapy Study LOV111821/OM5XX efficacy assessment.||Percentage change||Full Range|Median
792429|NCT00892099|Secondary|Serum Phosphate||every 4 weeks for 12 weeks||||||
792430|NCT00892099|Secondary|Serum Calcium||every 4 weeks for 12 weeks||||||
792329|NCT00891293|Primary|Percent Change in Serum Triglycerides From LOV111859/OM5 (Double-blind [DB] Study) Baseline to Week 8 of LOV111860/OM5X (1st Open-label [OL] Extension Study) and From LOV111859/OM5 (DB) Baseline to Month 24 of LOV111821/OM5XX (2nd OL Extension).|Median Percent Change in Serum Triglycerides from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change of Serum Triglycerides from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.|Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24|Modified Intent-To-Treat (MITT) Population is defined as subjects who have a baseline assessment in Study LOV111859/OM5 and at least one on-therapy Study LOV111821/OM5XX efficacy assessment.||Percentage change||Full Range|Median
792330|NCT00891371|Secondary|Percentage of Patients Having Minimum Reduction of At Least 50% or Normalization of the Mean Number of Stools||Day 56|ITT Population; Missing number of subjects: 1||Percentage of participants|||Number
792331|NCT00891371|Secondary|Change From Baseline in Relative Frequency of Normalization (≤3 Stools) in Subjects|Normalization of stool frequency in subjects with refractory diarrhoea at Day 28 and Day 56 (mean of last 7 days) compared to Baseline.|Baseline (Day 1), Day 28 and Day 56|ITT Population; Missing number of subjects = 1||Percentage of days per Week||Standard Deviation|Mean
792332|NCT00891371|Secondary|Percent Change in Mean Number of Stools Compared to Baseline||Baseline (Day 1), Day 28 and Day 56|ITT Population; Missing number of subjects = 1||Percent change||Standard Deviation|Mean
792333|NCT00891371|Secondary|Change in Median Score of Stool Consistency (Bristol Stool Form Scale) Compared to Baseline|Each patient scored his/her stool on the Bristol Stool Form Scale: Type 1 - Separate hard lumps, like nuts (hard to pass); Type 2 - Sausage-shaped but lumpy; Type 3 - Like a sausage but with cracks on its surface; Type 4 - Like a sausage or snake, smooth and soft; Type 5 - Soft blobs with clear-cut edges (passed easily); Type 6 - Fluffy pieces with ragged edges, a mushy stool; Type 7 - Water no solid pieces, Entirely liquid|Baseline (day 1), day 28 and day 56|ITT Population; Missing number of subjects = 1||units on a scale||Full Range|Median
792334|NCT00891371|Secondary|Change in QOL-Quality of Life {Assess Using Short Form (SF-36) and Irritable Bowel Syndrome (IBS)-QOL} Compared to Baseline|"SF36 QOL includes 1 multi-item scale measuring each of 8 health concepts. These scores are summed to produce raw scale scores for each health concept which are transformed to a 0-100 scale. The lower the score the more disability. The higher the score the less disability. There is in addition a single-item measure of Health Transition
IBS-QOL is a self-report QOL measure specific to IBS that can be used to assess impact of IBS and its treatment. This consists of 34 items,each with a 5 point response scale.Individual responses to 34 items are summed and averaged for a total score and transformed to a 0-100 scale with higher scores indicating better IBS specific QOL"|Baseline (Day 1), Day 21, Day 28, Day 49 and Day 56|ITT Population, Analysis based on number (n) of patients with a valid value.||units on a scale||Standard Deviation|Mean
792335|NCT00891371|Primary|Percentage of Patients Having Minimum Reduction of 50% or Normalization (≤3 Stools/24hours) in the Mean Number of Stools (Mean of Last 7 Days)||Day 28|Intention to Treat (ITT) Population [All treated subjects with at least 3 Days of available primary efficacy variable data for both Baseline and post Baseline periods]||Percentage of patients|||Number
792336|NCT00891618|Primary|Mean Neuropathy Severity Score (FACT-GOG-Ntx Total Score Assessment)|Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Neurotoxicity Scale (FACT/GOG-Ntx) Version 4 used to assess efficacy of acupuncture for treatment-induced peripheral neuropathy among multiple myeloma and/or lymphoma patients. Severity of neuropathy measured by FACT-GOG-Ntx total score assessment where 11-item questionnaire 5 point rating scale (0=“not at all” and 4=equals “very much”). FACT/GOG-Ntx Total Score ranges from 0 (best possible outcome) to 44 (worst possible outcome).|Baseline to Week 13. Assessments at baseline, once per week during the two treatment phases of the study, and one month (week 13) after the last acupuncture treatment.|Participants were excluded from primary outcome if did not complete follow up assessments.||units on a scale||Standard Deviation|Mean
792337|NCT00891657|Primary|Area of Sites Adherent to the Uterus (cm^2)||8-12 weeks post myomectomy|||cm^2||Standard Deviation|Mean
792338|NCT00891657|Primary|Mean Extent Score of Sites Adherent to the Uterus|0 =no adhesions, 1=covering <25% of locations’ total area, 2=covering 26% to 50% of locations’ total area, and 3=covering >51% of locations’ total area.|8-12 weeks post myomectomy|||Scores on a Scale||Standard Deviation|Mean
792339|NCT00891657|Primary|Mean Severity Score of Sites Adherent to the Uterus|The scoring for severity is as follows: 0=no adhesions, 1=filmy, avascular adhesions, 2=vascular and/or dense adhesions, and 3=cohesive adhesions.|8-12 weeks post myomectomy|Number of subjects to have had a second laparoscopic look.||Scores on a Scale||Standard Deviation|Mean
792340|NCT00891657|Primary|Number of Sites Adherent to the Uterus|The number of times an adhesion is attached to the uterus.|8-12 weeks post myomectomy|Number of subjects to have had a second laparoscopic look.||Adhesion Sites||Standard Deviation|Mean
792341|NCT00891735|Secondary|Change From Baseline in the Total Area of Choroidal Neovascularization (CNV) and Choroidal Neovascular Leakage at Month 12|The total area of choroidal neovascularization (CNV) and choroidal neovascular leakage was assessed with fluorescein angiography (FA). Area was measured in disc area units; 1 disc area unit = 2.54 mm^2.|Baseline to Month 12|Intent-to-treat population: All randomized patients. Missing data were imputed using the last observation carried forward method.||Disc area units||Standard Deviation|Mean
792342|NCT00891735|Secondary|Change From Baseline in Macular Volume at Day 7 and Months 1, 2, 3, 4, 6, 9, and 12|Macular volume was assessed by spectral domain optical coherence tomography (SD-OCT).|Baseline to Day 7 and Months 1, 2, 3, 4, 6, 9, and 12|Intent-to-treat population: All randomized patients. Missing data were imputed using the last observation carried forward method.||mm^3||Standard Deviation|Mean
792343|NCT00891735|Secondary|Change From Baseline in Central Foveal Thickness at Day 7 and Months 1, 2, 3, 4, 6, 9, and 12|Central foveal thickness was assessed by spectral domain optical coherence tomography (SD-OCT).|Baseline to Day 7 and Months 1, 2, 3, 4, 6, 9, and 12|Intent-to-treat population: All randomized patients. Missing data were imputed using the last observation carried forward method.||µm||Standard Deviation|Mean
792386|NCT00891982|Primary|Local Tolerability - Erythema (Redness)|"Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:
0 - None
- Trace
- Mild
- Moderate
- Marked
- Severe"|Week 2|||Participants|||Number
792431|NCT00892099|Secondary|Cytokine Profiles||every 4 weeks for 12 weeks||||||
792344|NCT00891735|Secondary|Percentage of Patients With no Evidence of Fluid From Choroidal Neovascularization (CNV) at Month 12|The presence of fluid from choroidal neovascularization (CNV) was assessed by spectral domain optical coherence tomography (SD-OCT). No evidence of fluid was defined as no subretinal fluid thickness, no cystoid spaces, no intraretinal fluid, no pigment epithelial defect thickness, and average central subfield thickness < 270 µm.|Month 12|Intent-to-treat population: All randomized patients. Missing data were imputed using the last observation carried forward method.||Percentage of patients||95% Confidence Interval|Number
792345|NCT00891735|Secondary|Percentage of Patients With a Visual Acuity (VA) Snellen Equivalent of 20/40 or Better at Month 12|VA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart starting at a test distance of 4 meters. An increase in the number of lines read correctly by the patient in the ETDRS chart indicates an improvement of vision. The Snellen equivalent of 20/40 is 14 lines correctly read in the EDTRS chart.|Month 12|Intent-to-treat population: All randomized patients. Missing data were imputed using the last observation carried forward method.||Percentage of patients||95% Confidence Interval|Number
792346|NCT00891735|Secondary|Percentage of Patients Who Gained ≥ 15 Letters in Best Corrected Visual Acuity (BCVA) From Baseline at Month 12|BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision.|Baseline to Month 12|Intent-to-treat population: All randomized patients. Missing data were imputed using the last observation carried forward method.||Percentage of patients||95% Confidence Interval|Number
792347|NCT00891735|Secondary|Number of Ranibizumab Injections up to But Not Including Month 12||Baseline to Month 12|All treated patients. Observed data were used with no imputation.||Injections||Standard Deviation|Mean
792348|NCT00891735|Primary|Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12|BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. A decrease in the BCVA score indicates a worsening of vision. A positive change score indicates improvement.|Baseline to Month 12|Intent-to-treat population: All randomized patients. Missing data were imputed using the last observation carried forward method.||Letters||Standard Deviation|Mean
792349|NCT00891774|Secondary|Subject’s Satisfaction of the Overall Treatment||1, 3 and 6 months post injection||||||
792350|NCT00891774|Secondary|Investigator’s Satisfaction of the Overall Treatment||1, 3 and 6 months post injection||||||
792351|NCT00891774|Secondary|Reduction in Wrinkle Severity Score||Baseline, 1, 3 and 6 months post injection||||||
792352|NCT00891774|Primary|Safety Endpoint|Safety Endpoint includes three categories: 1) composite determination of success (no pigmentation change or keloid formation); 2) pigmentation changes; and 3) keloid formation|6 months post injection|||Participants|||Number
792353|NCT00891813|Secondary|Number of Participants With Hypercalcemia (>10.5mg/dL), Hyperphosphatemia (>6.5mg/dL) and/or Elevations of the Ca X P Product (>65).|The number of participants with hypercalcemia (defined as at least one calcium value of more than 10.5 milligrams per deciliter [mg/dL]), hyperphosphatemia (phosphorus value of more than 6.5 mg/dL), and/or elevation of Calcium X Phosphorus product (value greater than 65) during the 24 week study.|24 Weeks|||Number of participants|||Number
792354|NCT00891813|Secondary|Time to Reach the First 30% Reduction in PTH and/or a Value Between 150-300pg/mL|Median time to achieve at least a 30% reduction in intact parathyroid hormone (iPTH) and/or an iPTH value in the range of 150-300 pg/mL.|24 Weeks|||Weeks||Inter-Quartile Range|Median
792355|NCT00891813|Primary|The Percentage of Patients Reaching at Least a 30% Reduction in PTH and/or Values in Range 150-300 pg/mL|The percentage of participants who achieved at least a 30% reduction in intact parathyroid hormone (iPTH) and/or an iPTH value in the range of 150 to 300 picograms per milliliter (pg/mL) at any post-baseline visit during the study. An iPTH value of 150-300 pg/ml is the target range recommended by the NKF KDOQI (National Kidney Foundation Kidney Disease Outcomes Quality Initiative) for End Stage Renal Disease patients.|24 weeks|Analysis is based on the number of participants completing the study.||Percentage of participants|||Number
792387|NCT00891982|Primary|Local Tolerability - Erythema (Redness)|"Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:
0 - None
- Trace
- Mild
- Moderate
- Marked
- Severe"|Week 1|||Participants|||Number
792432|NCT00892099|Primary|Serum 25D Level||12 weeks|||ng/ml||Standard Deviation|Mean
792362|NCT00891904|Secondary|Overall Survival||very 2 months for year one, every 3-4 months for year 2, every 6 months for years 3 and 4 and annually thereafter|Trial terminated early. Too few patients to analyze.|||||
792363|NCT00891904|Secondary|Local and Distant Control||very 2 months for year one, every 3-4 months for year 2, every 6 months for years 3 and 4 and annually thereafter.|Trial terminated early. Too few patients to analyze.|||||
792364|NCT00891904|Secondary|Feasibility as Assessed According to Ability to Deliver the Entire Treatment Regimen to 80% of Patients||2 years|Trial terminated early. Too few patients to analyze.|||||
792365|NCT00891904|Primary|Grade 4-5 Toxicity as Assessed by NCI CTCAE v.30||Daily while on Treatment|Trial terminated early. Too few patients to analyze.|||||
792366|NCT00891930|Secondary|Number of Subjects With Worst Post-baseline Grade 3 or Higher Laboratory Toxicities|The severity of laboratory toxicities was graded using CTCAE v3.0.|From first dose date to 30 days since the last dose date in each part of the study. The median time frame is 4.2 months for Part 1 and 2.4 months for Part 2.|Primary Analysis Set - Part 1 and Part 2||participants|||Number
792367|NCT00891930|Secondary|Number of Participants With Adverse Events|The severity of each adverse event (AE) was graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (where 1 = Mild [aware of sign or symptom, but easily tolerated]; 2 = Moderate [discomfort enough to cause interference with usual activity]; 3 = severe [incapacitating with inability to work or do usual activity]; 4 = life-threatening; 5 = fatal), with the exception of selected skin toxicities that were graded using a modified version of CTC. Treatment-related adverse events were those events for which the investigator considered there to be a reasonable possibility that the event may have been caused by panitumumab (Part 1) and by panitumumab and/or ganitumab (Part 2). Discontinuation includes AEs leading to discontinuation of panitumumab (Part 1) and panitumumab, ganitumab (Part 2) or removal from the study.|From first dose date to 30 days since the last dose date in each part of the study. The median time frame is 4.2 months for Part 1 and 2.4 months for Part 2.|Primary Analysis Set - Part 1 and Part 2||participants|||Number
792368|NCT00891930|Secondary|Number of Participants Who Developed Antibodies to Ganitumab|Two validated assays were used to detect the presence of anti-ganitumab antibodies. First, an eletrochemiluminescent bridging immunoassay was used to detect binding antibodies (screening assay) and confirm antibodies (confirmatory assay) capable of binding ganitumab. Second, a cell-based bioassay was used to test positive binding antibody samples for neutralizing activity against ganitumab.|From first dose of ganitumab until 30 days after last dose; median time frame was 2.4 months.|Primary Analysis Set - Part 2 particpants with at least 1 post-baseline immunoassay result.||participants|||Number
792369|NCT00891930|Secondary|Number of Participants Who Developed Antibodies to Panitumumab|Two screening immunoassays, an acid-dissociation enzyme-linked immunosorbent assay (ELISA) and a Biacore-based biosensor assay, were used to detect antibodies capable of binding to panitumumab. Postive samples were further tested for neutralizing antibodies in a cell-based epidermal growth factor receptor (EGFR) phosphorylation bioassay.|From first dose date to 30 days since the last dose date. The median time frame is 4.2 months for Part 1 and 2.4 months for Part 2.|Primary Analysis Set - Part 1 participants with at least 1 post-baseline immunoassay result.||participants|||Number
792370|NCT00891930|Secondary|Duration of Response|Duration of response is defined as the time from the first confirmed objective response to the earlier date of disease progression or death. An objective response is defined as a confirmed complete response or partial response per modified RECIST v1.0 criteria during the treatment period.|From the first dose of study drug until the data cut-off date of 30 July 2013. Median time on study follow-up was 48.5 weeks for Part 1 and 32 weeks in Part 2.|Tumor Response Evaluable Analysis Set - Part 1 and Part 2 participants with an objective response||months||95% Confidence Interval|Median
792371|NCT00891930|Secondary|Time to Objective Response|Time to objective response was defined as the time from first dose of study drug to the first confirmed objective response. An objective response is defined as a confirmed complete response or partial response per modified RECIST v1.0 criteria during the treatment period.|From the first dose of study drug until the end of treatment in each Part; median duration of treatment was 16 weeks in Part 1 and 8 weeks in Part 2.|Tumor Response Evaluable Analysis Set - Part 1 and Part 2 participants with an objective response||months||Full Range|Median
792372|NCT00891930|Secondary|Overall Survival (OS)|Overall survival was defined as the time from the first dose of study therapy in Part 1 or Part 2 to the date of death. Participants who had not died by the analysis data cutoff date were censored at their last contact date.|From the first dose of study drug until the data cut-off date of 30 July 2013. Median time on study follow-up was 48.5 weeks for Part 1 and 32 weeks in Part 2.|Primary Analysis Set - Part 1 and Part 2||months||95% Confidence Interval|Median
792388|NCT00891982|Primary|Local Tolerability - Erythema (Redness)|"Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:
0 - None
- Trace
- Mild
- Moderate
- Marked
- Severe"|Screening/baseline|||Participants|||Number
792373|NCT00891930|Secondary|Progression-free Survival (PFS)|Progression-free survival was defined as the interval from the first dose of study therapy to the earlier date of disease progression (per modified RECIST version 1.0) or death prior to the analysis data cutoff date, initiating a new line of anti-tumor therapy, and receiving study treatment in Part 2 where applicable. Participants who had not progressed or died during this period were censored at their last evaluable disease assessment date. Progressive Disease (PD): At least a 20% increase in the size of target or non-target lesions, significant increase in pleural effusions, ascites, or other fluid collections with cytologic proof of malignancy, or any new lesions.|From the first dose of study drug until the data cut-off date of 30 July 2013. Median time on study follow-up was 48.5 weeks for Part 1 and 32 weeks in Part 2.|Primary Analysis Set - Part 1: participants who had known wild-type KRAS tumors from archival tumor sample and who received at least 1 dose of panitumumab and/or irinotecan. Part 2: participants who had radiographically confirmed disease progression on treatment in Part 1 and received at least 1 dose of panitumumab and/or ganitumab in Part 2.||months||95% Confidence Interval|Median
792374|NCT00891930|Secondary|Part 1: Objective Response Rate|"Objective response rate is defined as the percentage of participants with either a confirmed complete response (CR) or partial response (PR) measured by the investigator per modified RECIST version 1.0 criteria during the treatment period.
Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions. Partial Response (PR): At least a 30% decrease in size of target lesions and no progression of non-target lesions and no new lesions, or, the disappearance of all target lesions, persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease and no new lesions."|From first dose of study drug until the end of treatment in Part 1; median duration of treatment was 16 weeks.|Tumor Response Evaluable Analysis Set – Part 1 (participants who had known wild-type KRAS tumors from archival tumor sample and who received at least 1 dose of panitumumab and/or irinotecan in Part 1 and with at least one Baseline uni-dimensionally measurable lesion per the RECIST version 1.0 based on investigators’ review).||percentage of participants||95% Confidence Interval|Number
792375|NCT00891930|Primary|Part 2: Objective Response Rate (ORR)|Objective response rate (ORR) is defined as the percentage of participants with either a confirmed complete response (CR) or partial response (PR) measured by the investigator per modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 criteria during the treatment period. Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions. Partial Response (PR): At least a 30% decrease in size of target lesions and no progression (increase in size) of non-target lesions and no new lesions, or, the disappearance of all target lesions, persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease (PD) and no new lesions.|From the first dose of study drug in Part 2 until the end of treatment in Part 2; median duration of treatment in Part 2 was 8 weeks.|Tumor Response Evaluable Analysis Set - Part 2 (participants who had radiographically confirmed disease progression on panitumumab and irinotecan in Part 1 and received at least 1 dose of panitumumab and/or ganitumab in Part 2 and with at least 1 baseline uni-dimensionally measurable lesion per the RECIST v1.0 based on investigators’ review.||percentage of participants||95% Confidence Interval|Number
792376|NCT00891930|Primary|Part 1: Emergence of Mutant KRAS|Mutation in Kirsten rat sarcoma-2 virus oncogene (KRAS) status was determined by examining KRAS exons 2, 3, and 4. The emergence of mutant KRAS was defined as a change in KRAS mutation status from wild-type at Baseline in KRAS exons 2, 3, and 4 to mutant in any of KRAS exons 2, 3, and 4 at the time of the second biopsy following the radiographic evidence of acquired resistance to panitumumab when given in combination with irinotecan.|From first dose of study drug until the 2nd biopsy at the time of disease progression/entry into Part 2; median duration of treatment in Part 1 was 16 weeks.|KRAS analysis set (participants with known wild-type KRAS tumors from archival tumor sample and who received at least 1 dose of panitumumab and/or irinotecan in Part 1 and with known KRAS status at baseline and at acquired disease resistance to panitumumab in combination with irinotecan (i.e., based on the results of the second biopsy on study).||percentage of participants||95% Confidence Interval|Number
792377|NCT00891982|Secondary|Subject Assessment of Itching|"Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:
0 - None
- Trace
- Mild
- Moderate
- Marked
- Severe"|Week 4|||Participants|||Number
792378|NCT00891982|Secondary|Subject Assessment of Itching|"Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:
0 - None
- Trace
- Mild
- Moderate
- Marked
- Severe"|Week 2|||Participants|||Number
792379|NCT00891982|Secondary|Subject Assessment of Itching|"Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:
0 - None
- Trace
- Mild
- Moderate
- Marked
- Severe"|Week 1|||Participants|||Number
792380|NCT00891982|Secondary|Subject Assessment of Itching|"Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:
0 - None
- Trace
- Mild
- Moderate
- Marked
- Severe"|Screening/Baseline|||Participants|||Number
792381|NCT00891982|Secondary|Subject Assessment of Burning/Stinging|"Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:
0 - None
- Trace
- Mild
- Moderate
- Marked
- Severe"|Week 4|||Participants|||Number
792382|NCT00891982|Secondary|Subject Assessment of Burning/Stinging|"Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:
0 - None
- Trace
- Mild
- Moderate
- Marked
- Severe"|Week 2|||Participants|||Number
792383|NCT00891982|Secondary|Subject Assessment of Burning/Stinging|"Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:
0 - None
- Trace
- Mild
- Moderate
- Marked
- Severe"|Week 1|||Participants|||Number
792384|NCT00891982|Secondary|Subject Assessment of Burning/Stinging|"Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:
0 - None
- Trace
- Mild
- Moderate
- Marked
- Severe"|Screening/baseline|||Participants|||Number
792385|NCT00891982|Primary|Local Tolerability - Erythema (Redness)|"Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:
0 - None
- Trace
- Mild
- Moderate
- Marked
- Severe"|Week 4|||Participants|||Number
792391|NCT00891982|Primary|Local Tolerability - Skin Scaling|"Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:
0 - None
- Trace
- Mild
- Moderate
- Marked
- Severe"|Week 1|||Participants|||Number
792392|NCT00891982|Primary|Local Tolerability - Skin Scaling|"Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:
0 - None
- Trace
- Mild
- Moderate
- Marked
- Severe"|Screening/baseline|||Participants|||Number
792393|NCT00891982|Primary|Local Tolerability - Skin Dryness|"Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:
0 - None
- Trace
- Mild
- Moderate
- Marked
- Severe"|Week 4|||participants|||Number
792394|NCT00891982|Primary|Local Tolerability - Skin Dryness|"Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:
0 - None
- Trace
- Mild
- Moderate
- Marked
- Severe"|Week 2|||participants|||Number
792395|NCT00891982|Primary|Local Tolerability - Skin Dryness|"Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:
0 - None
- Trace
- Mild
- Moderate
- Marked
- Severe"|Week 1|||participants|||Number
792396|NCT00891982|Primary|Local Tolerability - Skin Dryness|"Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:
0 - None
- Trace
- Mild
- Moderate
- Marked
- Severe"|Screening/baseline|||participants|||Number
792397|NCT00891995|Secondary|BMI Percentile||1 year|||percent||Inter-Quartile Range|Median
792398|NCT00891995|Secondary|Daily Insulin Dose||1 year|||u/day/kg||Standard Deviation|Mean
792399|NCT00891995|Secondary|CGM Measured Glucose Outcomes|Include a series of glucose indices created from CGM measured glucose data, such as % time with glucose values <=70 mg/dl, % time with glucose values within target range of 71-180 mg/dl, % time with glucose values >180 mg/dl, and glucose variability as measured by coefficient of variation. These indices were calculated by giving equal weight to each of the 24 h of the day. At least 24 h of CGM data were required for calculating these indices.|1 year|Participants who used CGM (either blinded or unblinded CGM) for at least 24 hours at 12 months.||percent||Inter-Quartile Range|Median
792400|NCT00891995|Secondary|CGM Mean Glucose||1 year|Participants who used CGM (either blinded or unblinded CGM) for at least 24 hours at 12 months.||mg/dL||Inter-Quartile Range|Median
792401|NCT00891995|Secondary|Adverse Events (Severe Hypoglycemia)||1 year|||participants|||Number
792402|NCT00891995|Secondary|HbA1c||1 year|||percent||Standard Deviation|Mean
792403|NCT00891995|Secondary|Incidence of the Loss of the 2 Hour Peak C-peptide < 0.2 Pmol/ml on a Semi-annual MMTT|Outcome measure in the table is the incidence of 2 hour peak C-peptide>=0.2 pmol/ml. Since the formal clinical trial stopped at 12 months due to lack of efficiency (later follow-up were used to collect data for secondary analyses by pooling the two groups), only the outcome at 12 months are reported.|0 to 240 min post meal at 1 year MMTT|Among the 68 participants who completed 1 year visit and with positive autoantibody, 1 participant in the intensive treatment group did not complete MMTT test, thus was excluded from all C-peptide analyses.||participants|||Number
792404|NCT00891995|Secondary|Peak C-peptide in Response to a Mixed Meal at 1 Year Following Enrollment||0 to 240 min post meal at 1 year MMTT|Among the 68 participants who completed 1 year visit and with positive autoantibody, 1 participant in the intensive treatment group did not complete MMTT test, thus was excluded from all C-peptide analyses.||pmol/ml||95% Confidence Interval|Geometric Mean
792405|NCT00891995|Primary|C-peptide Average Area Under the Curve (AUC) in Response to a Mixed Meal at 1 Year Following Enrollment.|In the primary analysis of the 12-month Mixed-Meal Tolerance Test (MMTT) results, the geometric mean (95% C.I.) of C-peptide average AUC (=AUC/time) was 0.43 (0.34, 0.52) pmol/ml in the intensive treatment group and 0.52 (0.32, 0.75) pmol/ml in the usual care group (P=0.49).|At baseline, MMTT data were collected at 0 and 90 min; at 12 months, MMTT data were collected at 0 to 240 min post meal|Among the 68 participants who completed 1 year visit and with positive autoantibody, 1 participant in the intensive treatment group did not complete MMTT test, thus was excluded from all C-peptide analyses.||pmol/ml||95% Confidence Interval|Geometric Mean
792406|NCT00892008|Primary|Discontinuations Due to Adverse Events|Discontinuations due to adverse events by MedDRA system organ class and preferred term.|Baseline, Second Visit (Week ≥ 2), Final Visit (Week 4)|Safety population: all subjects who took at least one dose of study medication.||participants|||Number
792407|NCT00892008|Secondary|Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit|Patient's Clinical Global Impression of tolerability. The tolerability item of CGI has a scale of five discrete points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit. Abbreviation: vst = visit.|Second Visit (Week ≥ 2), Final Visit (Week 4)|Intent to treat (ITT) population: a subset of the safety population who underwent Baseline assessment, received study drug for at least 2 weeks, and had at least 1 follow-up visit. N=number of subjects in ITT population.||participants|||Number
792408|NCT00892008|Secondary|Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist|Physician's Clinical Global Impression of tolerability. Tolerability item of CGI has a scale of five discrete points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit.|Second Visit (Week ≥ 2), Final Visit (Week 4)|Intent to treat (ITT) population: a subset of the safety population who underwent Baseline assessment, received study drug for at least 2 weeks, and had at least 1 follow-up visit. N=number of subjects in ITT population.||participants|||Number
792433|NCT00892151|Secondary|Number of Participants Who Rated Clarity and Usefulness of User Instructions as >=3|"User instructions included online help, User Guide, and a Quick Reference Guide. Subjects rated their clarity and usefulness and the rating scale was:
= Unacceptable
= Poor
= Good
= Very Good
= Excellent"|1-2 hours|Some subjects had no opinion; the number of subjects that did respond with ratings are identified in parentheses.||participants|||Number
792409|NCT00892008|Secondary|Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit|Patient's Clinical Global Impression of efficacy. Efficacy item of CGI has a scale of five discrete points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit.|Second Visit (Week ≥ 2), Final Visit (Week 4)|Intent to treat (ITT) population: a subset of the safety population who underwent Baseline assessment, received study drug for at least 2 weeks, and had at least 1 follow-up visit. N=number of subjects in ITT population.||participants|||Number
792410|NCT00892008|Secondary|Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit|Physician's Clinical Global Impression of efficacy. Efficacy item of the CGI has a scale of five discrete points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit.|Second Visit (Week ≥ 2), Final Visit (Week 4)|Intent to treat (ITT) population: a subset of the safety population who underwent Baseline assessment, received study drug for at least 2 weeks, and had at least 1 follow-up visit. N=number of subjects in ITT population.||participants|||Number
792411|NCT00892008|Secondary|Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits|Patient's Clinical Global Impression of treatment satisfaction. Treatment satisfaction item of CGI has a scale of five discrete points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit.|Second Visit (Week ≥ 2), Final Visit (Week 4)|Intent to treat (ITT) population: a subset of the safety population who underwent Baseline assessment, received study drug for at least 2 weeks, and had at least 1 follow-up visit. N=number of subjects in ITT population.||participants|||Number
792412|NCT00892008|Secondary|Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits|Physician's Clinical Global Impression of treatment satisfaction. Treatment satisfaction item of the CGI has a scale of five discrete score points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit.|Second Visit (Week ≥ 2), Final Visit (Week 4)|Intent to treat (ITT) population: a subset of the safety population who underwent Baseline assessment, received study drug for at least 2 weeks, and had at least 1 follow-up visit. N=number of subjects in ITT population.||participants|||Number
792413|NCT00892008|Secondary|VAS Pain Score at Baseline and Final Visit|VAS Pain Score 10 cm (10-point) pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. Shift table shows the number of subjects with each pain intensity rating at the Final Visit by the number of subjects with each pain intensity rating at Baseline. Abbreviations: mod = moderate, sev = severe, wrst = worst, poss = possible, pn = pain, vst = visit.|Baseline, Final Visit (Week 4)|Intent to treat (ITT) population: a subset of the safety population who underwent Baseline assessment, received study drug for at least 2 weeks, and had at least 1 follow-up visit. N=number of subjects in ITT population.||participants|||Number
792414|NCT00892008|Secondary|VAS Pain Score at Baseline (BL) and Second Visit|VAS Pain Score: 10 cm (10-point) pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. Shift table shows the number of subjects with each pain intensity rating at the Second Visit by the number of subjects with each pain intensity rating at Baseline. Abbreviations: mod = moderate, sev = severe, wrst = worst, poss = possible, pn = pain, vst = visit .|Baseline, Second Visit (Week ≥ 2)|Intent to treat (ITT) population: a subset of the safety population who underwent Baseline assessment, received study drug for at least 2 weeks, and had at least 1 follow-up visit. N=number of subjects in ITT population.||participants|||Number
792415|NCT00892008|Secondary|Change From Baseline in Visual Analogue Scale (VAS) Score|Change from Baseline in 10 cm VAS pain score; 10-point pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. Change = scores at second visit and final visit minus score at Baseline.|Baseline, Second Visit (Week ≥ 2), Final Visit (Week 4)|Intent to treat (ITT) population: a subset of the safety population who underwent Baseline assessment, received study drug for at least 2 weeks, and had at least 1 follow-up visit. N = number of subjects with a Visual Analog Scale (VAS) pain score at Baseline Visit.||scores on scale||Standard Deviation|Mean
792416|NCT00892008|Primary|Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)|Number and severity of adverse events, including serious adverse events. If the same subject had more than one occurance in the same preferred term event category, only the most severe occurrence was taken.|Baseline through Final Visit (Week 4)|Safety population: all subjects who took at least 1 dose of study medication.||participants|||Number
792417|NCT00892047|Secondary|QTc Prolongation on EKG (to Greater or Equal to 480 Msec)|percentage of participants|12 weeks|We had a smaller number of participant observations due to dropouts and missing data. This data is in Table 3 of the manuscript.||percent of participants|||Number
792418|NCT00892047|Secondary|Emergent Suicidal Ideation in Those With no Ideation at the Start of Treatment|percentage of participants who reported suicidal ideation during treatment but not at baseline|12 weeks|It is a smaller number of participants restricted to those who did not report any suicidal ideation at baseline. This is in Table 3of the manuscript||percent of participants|||Number
792419|NCT00892047|Primary|Parkinsonism|Percentage of participants who develop signs of parkinsonism|12weeks|We have a lower number of participants analyzed due to dropouts and missed assessments.||percentage of participants|||Number
792420|NCT00892047|Primary|Weight|Weight change in kilograms|Baseline through12 weeks|The number of participants analyzed is lower due to missing data attributable to dropouts. The information obtained is from figure 3B in the manuscript||kilograms||Standard Deviation|Mean
792421|NCT00892047|Primary|Akathisia|Percentage of participants who developed clinically significant akathisia.|12 weeks|||percentage of participants|||Number
792422|NCT00892047|Primary|Percentage of Subjects Who Met Criteria for Remission Based on the Montgomery-Asberg Depression Rating Scale (MADRS)|The Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician rated ten item instrument assessing depression symptoms. Possible scores range from 0-60; higher scores indicate greater severity of depression. Remission defined as score of 10 or less based on the MADRS.|12 weeks|||percentage of participants|||Number
792423|NCT00892099|Secondary|Cardiac Hospitalizations and Mortality||1 year||||||
792434|NCT00892151|Secondary|Percentage of Participants Who Rated Ease of Performing Specific Tasks As <=3|"Subjects rated ease of using the software with respect to specific tasks. The rating scale was:
= Very Simple
= Simple
= Neither Simple nor Difficult
= Difficult
= Very Difficult"|1-2 hours|Note: 2 tasks were performed only by the 10 healthcare professionals. Also, one lay person was withdrawn (leaving 50 participants). The subject was a parent of a child with diabetes; the 17 year old child performed the software evaluation instead of the parent. Data for the subject withdrawn from the study was not used in the analysis.||percentage of participants|||Number
792435|NCT00892151|Primary|Number of Participants Rated Successful (<=3) at Performing Specific Tasks|"Study staff rated participants on their success at perfoming specific tasks. The rating scale was:
= Successful
= Successful after being referred to user instructions
= Successful with verbal assistance or review of part of user instructions (Similar to review of a specific function during a Customer Service call.)
= Unsuccessful (Incorrectly performed part of the testing regimen or required intervention by study staff.)
= Problem encountered with software"|1-2 hours|Note: 2 tasks were performed only by the 10 healthcare professionals. Also, one lay person was withdrawn (leaving 50 participants). The subject was a parent of a child with diabetes;the 17 year old child performed the software evaluation instead of the parent. Data for the subject withdrawn from the study was not used in the analysis.||participants|||Number
792436|NCT00892177|Secondary|Objective Response (Phase II)|Objective response to treatment will be determined by the results of neurological exam and the MRI and/or CT measurement of the tumor at each evaluation as is used for all NCCTG neuro-oncology trials. The percentage of patients in each response category will be summarized, 95% confidence intervals calculated, and rates between the 2 arms will be compared using a Fisher’s Exact test. For bi-dimensionally measurable disease, CR: total disappearance of all tumor and that patients be on no corticosteroids or on only adrenal replacement maintenance; PR: ≥ 50% reduction in product of perpendicular diameters of contrast enhancement or mass with no new lesions, and stable or decreasing steroid dosing; PD: >25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions; REGR: unequivocal reduction in extent of contrast-enhancement, or a decrease in mass effect, no new lesions (for evaluable disease); SD: failure to qualify for CR, PR,REGR or PD.|Up to 3 years|All eligible Phase II patients are included in this Phase II endpoint analysis.||percentage of participants||95% Confidence Interval|Number
792437|NCT00892177|Secondary|Patient-reported QOL, as Measure by the Functional Assessment of Cancer Therapy-Brain (FACT-Br) (Phase II)|"FACT-Br questionnaires were used to assess QOL at every other cycle of treatment (prior to cycles 3, 5, 7, etc.). FACT-Br includes 50 questions used to assess patients' self-assessment in 4 broad categories: Physical, Social/Family, Emotional, and Function Well-being. Scores range from 0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit, 4=Very Much. Higher scores can be interpreted as having higher quality of life. The scores for all 50 questions were summed to give a total score per patient per cycle. Therefore the possible range is from 0 to 200. Below is the reported mean and standard deviation for patients at baseline and during cycles 2, 4, 6, 8, and 10."|Baseline to cycle 10 (20 weeks).|All Phase II patients that began treatment and submitted at least one FACT-Br questionnaire were included in this analysis.||units on a scale||Standard Deviation|Mean
792438|NCT00892177|Secondary|Time-to-disease Progression (Phase II)|Time-to-disease progression is defined as the time from start of study therapy to documentation of disease progression. Patients who die without documentation of progression will be considered to have had tumor progression at the time of death unless there is documented evidence that no progression occurred before death. Patients who fail to return for evaluation after beginning therapy will be censored for progression on the last day of therapy or date last known to be alive, whichever is later. Patients who are still alive and have not progressed will be censored for progression at the time of the last tumor assessment. Patients who experience major treatment violations will be censored for progression on the date the treatment violation occurred. The time-to-progression distribution will be estimated using the Kaplan-Meier method.|Up to 3 years|All eligible Phase II patients are included in this Phase II endpoint analysis.||months||95% Confidence Interval|Median
792439|NCT00892177|Secondary|Overall Survival (Phase II)|Survival time is defined to be the length of time from start of study therapy to death due to any cause. All patients meeting the eligibility criteria that have signed a consent form and begun treatment will be considered evaluable for estimation of the survival distribution. The distribution of overall survival for both arms of the study will be estimated using the Kaplan-Meier method, and be compared using log-rank tests.|Up to 3 years|All eligible Phase II patients are included in this Phase II endpoint analysis.||months||95% Confidence Interval|Median
792440|NCT00892177|Secondary|Number of Participants With Adverse Events According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0 (Phase II)|"Adverse events were collected systematically at the end of each cycle and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0. Events are scored as: 1=Mild symptoms, 2= Moderate, 3=Severe, 4=Life-threatening, and 5=Death. The number of patients reporting a grade 3 or higher event regardless of attribution are summarized here. A complete list of all adverse events reported during treatment can be found in the Adverse Events Section."|Up to 3 years|All Phase II patients treated and evaluated for adverse events are included in this Phase II endpoint analysis.||participants|||Number
792441|NCT00892177|Primary|Progression-free Survival at 6 Months (PFS6) (Phase II)|The primary endpoint is the proportion of patients alive and progression-free 6 months after study treatment initiation (PFS6). All eligible consented patients that received treatment will be considered evaluable. Those who die will be considered to have had disease progression unless documented evidence clearly indicates no progression has occurred. PFS6 is defined as the time from start of study therapy to the date of first observation of disease progression or death due to any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The PFS6 will be estimated as the number of evaluable patients progression free and still alive at 6 months divided by the total number of evaluable patients. The confidence interval will be calculated according to the Clopper-Pearson Method.|6 months|All patients that received treatment and were eligible for assessment were included in this analysis.||proportion of participants||90% Confidence Interval|Number
792481|NCT00892957|Secondary|Laboratory Values Over Time: Aspartate Aminotransferase (AST)||Preoperative baseline through postoperative Day 14|Safety Analysis Data Set||U/L||Full Range|Median
792442|NCT00892177|Primary|Number of Participants With Dose Limiting Toxicities to Determine Maximum Tolerated Dose (MTD) of Dasatinib in Combination With Bevacizumab (Phase I)|The Maximum Tolerated Dose (MTD) will be based on the assessment of dose-limiting toxicities (DLT) during the first 4 weeks of treatment only (i.e., following the first 2 treatment cycles), and will be defined as the dose at which fewer than one-third of patients experience a DLT to study treatment. The MTD is the dose level at which 0/6 or 1/6 patients experience DLT with the next higher dose having at least 2 out of 3 or 2 out of 6 patients encountering DLT. > Three patients will be treated at each dose level, and can be enrolled simultaneously. If one DLT is encountered, an additional 3 patients will be added to that dose level. If at any point two DLTs are encountered within a given dose level, then the MTD has been exceeded and if only three patients have been treated at the next lower dose three more patients are treated at the next lower dose. The number of patients who developed DLTs are reported here by dose level, with the MTD reported in the statistical analysis section.|14 days|Adverse event information is available for 4 patients on study 1 dose level 1 (with 1 being a MTD replacement due to disease progression prior to completing cycles 1 and 2).||participants who developed DLTs|||Number
792443|NCT00892281|Secondary|Number of Treatment Responders at Endpoint, Where Response is Defined as an IGA Score of 0 (Clear) or 1 (Near Clear)|Number of treatment responders at week 12, where response is defined as an Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (near clear). IGA is measured on a scale from 0 - 4 with 0 = Clear, 1 = Near Clear; 2 = Mild; 3 = Moderate; and 4 = Severe with 0 being best and 4 being worst.|Baseline to Week 12|||participants|||Number
792444|NCT00892281|Secondary|Change in Clinician's Erythema Assessment Scale (CEA) Score From Baseline to Endpoint|Number of participants with a change (Week 12 minus Baseline) in Clinician's Erythema Assessment Scale (CEA) score. Clinician's Erythema Assessment Scale (CEA) is a scale from 0 - 4 with 0 = None; 1 = Mild; 2 = Moderate; 3 = Significant; and 4 = Severe. Results values (+4, +3, +2, +1, 0, -1, -2, -3, -4) represent change from Baseline to Week 12 in CEA.|Baaseline to Week 12|||participants|||Number
792445|NCT00892281|Primary|Change in Investigator's Global Assessment (IGA) Score From Baseline to Endpoint|Number of participants with a change (Week 12 minus Baseline) in Investigator's Global Assessment (IGA) score. IGA is measured on a scale from 0 - 4 with 0 = Clear; 1 = Near Clear; 2 = Mild; 3 = Moderate; and 4 = Severe. Results values (+4, +3, +2, +1, 0, -1, -2, -3, -4) represent change from Baseline to Week 12.|Baseline to Week 12|Per protocol||participants|||Number
792446|NCT00892437|Secondary|Change From Baseline in CD4 Cell Count at Week 48|The change from baseline in CD4 cell count at Week 48 was analyzed.|Baseline to Week 48|Participants in the ITT Analysis Set with available change data at Week 48 were analyzed.||cells/μL||Standard Deviation|Mean
792447|NCT00892437|Secondary|Change From Baseline in CD4 Cell Count at Week 24|The change from baseline in CD4 cell count at Week 24 was analyzed.|Baseline to Week 24|Participants in the ITT Analysis Set with available change data at Week 24 were analyzed.||cells/μL||Standard Deviation|Mean
792448|NCT00892437|Secondary|Change From Baseline in HIV-1 RNA at Week 48|The change from baseline in log_10 HIV-1 RNA at Week 48 was analyzed.|Baseline to Week 48|Participants in the ITT Analysis Set with available change data at Week 48 were analyzed.||log_10 copies/mL||Standard Deviation|Mean
792449|NCT00892437|Secondary|Change From Baseline in HIV-1 RNA at Week 24|The change from baseline in log_10 HIV-1 RNA at Week 24 was analyzed.|Baseline to Week 24|Participants in the ITT Analysis Set with available change data at Week 24 were analyzed.||log_10 copies/mL||Standard Deviation|Mean
792450|NCT00892437|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the missing = failure method.|Week 48|ITT Analysis Set||percentage of participants|||Number
792451|NCT00892437|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the missing = failure method, where participants with missing data were considered to have failed to achieve the endpoint.|Week 24|ITT Analysis Set: participants who were randomized and received at least one dose of study drug.||percentage of participants|||Number
792452|NCT00892606|Secondary|Visual Pain Score|Patients rated their pain with the numerical VPS from 0 to 10, with 10 being the worst pain possible and 0 being no pain|48 hours|||units on a scale||Standard Deviation|Mean
792453|NCT00892606|Secondary|Number of Participants With Post Operative Nausea and Vomiting|rates subjects experienced PONV|48 hours|||Participants|||Count of Participants
792454|NCT00892606|Primary|Opioid Consumption During the 48 Hours After Surgery|The amount of opioid required for postoperative pain relief|48 hours|||mg||Standard Deviation|Mean
792455|NCT00892697|Secondary|Intrahepatic and Peripheral Pharmacokinetic Assessment of Telaprevir|Intrahepatic and plasma telaprevir concentration ratios|Day 1, Day 4, Day 15, Week 8|||telaprevir liver to plasma conc ratio||Inter-Quartile Range|Median
792456|NCT00892697|Primary|Intrahepatic and Plasma HCV Viral Kinetics|Intrahepatic viral kinetics, plasma viral kinetics,|Day-7, Day 1, Day 4,|||log transformed copies/ml||Standard Deviation|Mean
792457|NCT00892710|Secondary|6-month and 12-month Overall Survival Probability|Overall Survival = The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death|12 months|Includes all enrolled patients, whether or not they received treatment||probability out of 1||95% Confidence Interval|Number
792458|NCT00892710|Secondary|Overall Survival (OS)|The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death|18 months|Includes all enrolled patients, whether or not they were treated||months||95% Confidence Interval|Median
792459|NCT00892710|Secondary|Time to Treatment Failure (TTTF)|Defined as the Length of Time, in Months, that Patients were Alive from the Date of First Treatment Until Treatment Discontinuation for Any Reason.|18 months|Includes all treated patients||months||Full Range|Median
792460|NCT00892710|Secondary|Time to Progression (TTP)|The Length of Time, in Months, That Patients Remain Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|18 months|Includes all treated patients||months||95% Confidence Interval|Median
792482|NCT00892957|Secondary|Laboratory Values Over Time: Alanine Aminotransferase (ALT)||Preoperative baseline through postoperative Day 14|Safety Analysis Data Set||U/L||Full Range|Median
792461|NCT00892710|Secondary|Overall Response Rate (ORR), the Number of Patients Who Experience an Objective Benefit From Treatment|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|18 months|Includes all treated patients||participants|||Number
792462|NCT00892710|Primary|Progression Free Survival (PFS)|The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|18 months|Includes all enrolled patients whether they recieved treatment or not||months||95% Confidence Interval|Median
792463|NCT00892723|Secondary|Between-group Mean Differences in Objective Measures Obtained Via 3D Photography (Volume)|This secondary outcome included measurements based on 3D photography of the scar surface at Month 12 and included positive volume, negative volume and total volume. All volume measurements were made relative to the interpolated smooth skin surface. A value closer to zero was preferred, because zero was equal to the normal skin surface. Positive volume was calculated as the volume of the scar above the interpolated smooth skin surface. Negative volume was calculated as the volume of the scar below the interpolated smooth skin surface, and was always a negative number. Total volume was calculated as the sum of the positive volume and the absolute value of the negative volume.|12 months|In this early phase study, the efficacy and safety analyses were performed using an evaluable subject sample, which included all subjects who received study agent and provided some efficacy or safety data.||Millimeters cubed||Standard Deviation|Mean
792464|NCT00892723|Secondary|Between-group Mean Differences in Objective Measures Obtained Via 3D Photography (Elevation, Length, Width)|This secondary outcome included measurements based on 3D photography of the scar surface at Month 12 and included maximum length, maximum width perpendicular to the maximum length, and minimum, maximum and mean elevation. All elevation measurements were made relative to the interpolated smooth skin surface. A value closest to zero was preferred, because zero was equal to the normal skin surface. The minimum elevation value was calculated as the lowest point of the scar below the interpolated smoooth skin surface and was always a negative number. A more negative number was worse, because it indicated a deeper measurement below the interpolated smooth skin surface. The maximum elevation value was calculated as the highest point of the scar above the interpolated smooth skin surface. A larger number was worse because it indicated a higher peak above the interpolated smooth skin surface. The mean elevation of the scar relative to the interpolated smooth skin surface was also calculated.|12 Months|In this early phase study, the efficacy and safety analyses were performed using an evaluable subject sample, which included all subjects who received study agent and provided some efficacy or safety data.||Millimeters||Standard Deviation|Mean
792465|NCT00892723|Secondary|Between-group Mean Differences in Visual Analog Scale (VAS) Scores by Independent Blinded Raters|At 12 months, two independent dermatologists who were blinded to study treatment evaluated the scar images using a Visual Analog Scale (VAS) of 0-100 mm, with 0 being normal skin and 100 being the worst scar imaginable. The scars were presented in a scrambled order. Efficacy was based on the difference between VAS scores of placebo and 0.3 mg AZX100, and placebo and 1 mg AZX100, for each of the two raters separately. Data from the two raters was not combined.|12 Months|In this early phase study, the efficacy and safety analyses were performed using an evaluable subject sample, which included all subjects who received study agent and provided some efficacy or safety data.||Millimeters||Standard Deviation|Mean
792466|NCT00892723|Primary|Differences Among the 3 Dosage Groups in the Patient (PSAS) and Observer (OSAS) Scar Assessment Scale (POSAS) Scores|Efficacy was based on the difference between mean POSAS scores of placebo, 0.3 mg AZX100, and 1 mg AZX100 12 months after surgery. This gave four comparisons to placebo: patient or observer and 0.3 mg and 1 mg AZX100. PSAS included patients' ratings on a scale of 1-10 (1 was normal skin or no complaints and 10 was the worst imaginable scar or the worst difference) for the following: Is the scar painful? Is the scar itching? Is the color of the scar different? Is the scar more stiff? Is the thickness of the scar different? Is the scar irregular? The possible minimum score was 6 and the maximum (worst) score was 60. OSAS included observers' ratings on a scale of 1-10 (1 was normal skin and 10 was the worst scar imaginable) for vascularization, pigmentation, thickness, relief, and pliability. The possible minimum score was 5 and the possible maximum (worst) score was 50.|12 Months|In this early phase study, the efficacy and safety analyses were performed using an evaluable subject sample, which included all subjects who received study agent and provided some efficacy or safety data.||Units on a scale||Standard Deviation|Mean
792483|NCT00892957|Secondary|Laboratory Values Over Time: Creatinine, Bilirubin, and Blood Urea Nitrogen (BUN)||Preoperative baseline through postoperative Day 14|Safety Analysis Data Set||mg/dL||Full Range|Median
792484|NCT00892957|Secondary|Laboratory Values Over Time: Platelets||Preoperative baseline through postoperative Day 14|Safety Analysis Data Set||x10^3/µl||Full Range|Median
792477|NCT00892957|Primary|Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Severe Bleeding|"Investigators were shown videos of bleeding severities to standardize assessments.
Severe bleeding defined as:
Either >50% of the suture line bleeds, or
≥10 suture line bleedings were present, if counting of suture line bleedings was possible, or
>1 pulsatile suture line bleeding was present, or
≥1 spurting suture line bleeding was present."|4 minutes post start of treatment application|Intent to Treat||percentage of participants||95% Confidence Interval|Number
792478|NCT00892957|Primary|Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Moderate Bleeding|"Investigators were shown videos of bleeding severities to standardize assessments.
Moderate bleeding defined as:
Either >25% of the suture line bleeds, or
≥5 suture line bleedings were present, if counting of suture line bleedings was possible, or
1 pulsatile suture line bleeding was present."|4 minutes post start of treatment application|Intent to Treat||percentage of participants||95% Confidence Interval|Number
792479|NCT00892957|Secondary|Laboratory Values Over Time: International Normalized Ratio(INR)||Preoperative baseline through postoperative Day 14|Safety Analysis Data Set||ratio||Full Range|Median
792480|NCT00892957|Secondary|Laboratory Values Over Time: Activated Partial Thromboplastin Time (aPTT)||Preoperative baseline through postoperative Day 14|Safety Analysis Data Set||seconds||Full Range|Median
792489|NCT00892957|Secondary|Percent Change in Vital Signs: Respiratory Rate|Percent Change in Heart Rate Measured as: Preoperative Baseline - Postoperative Day 1; and Preoperative Baseline - Postoperative Day 14|Within 14 days prior to surgery through postoperative day 14|Safety Analysis Set||percent change||Full Range|Median
792490|NCT00892957|Secondary|Vital Signs: Respiratory Rate - Preoperative Baseline||Within 14 days prior to date of surgery|Safety Analysis Set||breaths per minute||Full Range|Median
792491|NCT00892957|Secondary|Percent Change in Vital Signs: Heart Rate|Percent Change in Heart Rate Measured as: Preoperative Baseline - Intraoperative Day 0; Preoperative Baseline - Postoperative Day 1; and Preoperative Baseline - Postoperative Day 14|Within 14 days prior to surgery through postoperative day 14|Safety Analysis Set||percent change||Full Range|Median
792492|NCT00892957|Secondary|Vital Signs: Heart Rate - Preoperative Baseline||Within 14 days prior to date of surgery|Safety Analysis Set||beats per minute||Full Range|Median
792493|NCT00892957|Secondary|Percent Change in Vital Signs: Systolic and Diastolic Blood Pressure|Percent Change in Systolic and Diastolic Blood Pressure (BP) Measured as: Preoperative Baseline - Intraoperative Day 0; Preoperative Baseline - Postoperative Day 1; and Preoperative Baseline - Postoperative Day 14|Within 14 days prior to surgery through postoperative day 14|Safety Analysis Set||percent change||Full Range|Median
792494|NCT00892957|Secondary|Vital Signs: Systolic and Diastolic Blood Pressure (BP)- Preoperative Baseline||Within 14 days prior to date of surgery|Safety Analysis Set||mm Hg||Full Range|Median
792495|NCT00892957|Secondary|Number of Participants With Infections by Grade|"Infections were recorded according to:
Grade I: only dermis affected
Grade II: infection invades subcutaneous region but not the arterial implant
Grade III: the arterial implant is infected"|post-op discharge/day 1, post-op day 14 and day 30|Safety Analysis Set||participants|||Number
792496|NCT00892957|Secondary|Percentage of Participants With Infection at the Surgical Site||post-op discharge/day 1, post-op day 14 and day 30|Safety Analysis Set||percentage of participants||95% Confidence Interval|Number
792497|NCT00892957|Secondary|Percentage of Participants With Graft Occlusion|Determined clinically and defined as absence of blood flow through the graft.|post-op discharge/day 1, post-op day 14 and day 30|Safety Analysis Set||percentage of participants||95% Confidence Interval|Number
792498|NCT00892957|Secondary|Percentage of Participants With Postoperative Rebleeding|Any rebleeding requiring surgical re-exploration|Postoperative through day 30 ± 5|Intent to treat||percentage of participants||95% Confidence Interval|Number
792499|NCT00892957|Secondary|Percentage of Participants With Intraoperative Rebleeding After Hemostasis at Study Suture Line|Intraoperative rebleeding at the study suture line after occurrence of hemostasis.|Intraoperative day 0|Intent to treat||percentage of participants||95% Confidence Interval|Number
792500|NCT00892957|Secondary|Percentage of Participants Who Achieved Hemostasis at 10 Minutes Post Treatment Application|Hemostasis at the study suture line must be maintained until closure of the surgical wound.|10 minutes post start of treatment application|Intent to treat||percentage of participants||95% Confidence Interval|Number
792501|NCT00892957|Secondary|Percentage of Participants Who Achieved Hemostasis at 6 Minutes Post Treatment Application|Hemostasis at the study suture line must be maintained until closure of the surgical wound.|6 minutes post start of treatment application|Intent to treat||percentage of participants||95% Confidence Interval|Number
792502|NCT00892957|Primary|Percentage of Participants Who Achieved Hemostasis at 4 Minutes Post Treatment Application.|Hemostasis at the study suture line must be maintained until closure of the surgical wound.|4 minutes post start of treatment application|Intent to Treat||Percentage of participants||95% Confidence Interval|Number
792503|NCT00893074|Secondary|Heart Rate|Heart rate measured after acute cannabis exposure|Assessed on Day 5 of dronabinol maintenance|||beats per minutes||Standard Error|Mean
792504|NCT00893074|Primary|"Subjective Drug Effect After Smoked Marijuana"|Subjective drug effects on a 100mm point Visual Analog Scale reported following acute cannabis dose administration during dronabinol maintenance, scale ranging 0-100, with 0 being no effect and 100 being maximum effect|Day 5 of the Dronabinol abstinence period|||mm of subjective drug effect||Standard Error|Mean
792505|NCT00893074|Primary|Peak Effect of Marijuana Withdrawal|Total withdrawal based on a composite score of the Marijuana Withdrawal Checklist (range 0-32; higher scores indicate greater withdrawal).|Day 5 of the Dronabinol abstinence period|||units on a scale||Standard Error|Mean
792506|NCT00893113|Secondary|Change in Total International Index of Erectile Function (IIEF) Score|The International Index of Erectile Function (IIEF) is used for the evaluation of male sexual function and diagnostic evaluation of Erectile Dysfunction (ED) severity. There are 5 domains of the IIEF: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. A score of 0-5 is awarded to each question of the IIEF. Total IIEF scores range from 0-75. Lower scores indicate severe erectile dysfunction (0=severe erectile dysfunction), while higher scores indicate less erectile dysfunction (75=no erectile dysfunction).|Baseline and 12 Weeks|The evaluable set includes all subjects who have sufficient data to assess the primary efficacy endpoint, and who have no major protocol deviations. Subjects were analyzed according to randomized treatment. Data for 45 subjects was analyzed.||Change in Total IIEF Score from Baseline||Standard Deviation|Mean
792507|NCT00893113|Secondary|Changes in American Urological Association (AUA) Symptom Index|The American Urological Association (AUA) Symptom Index is used to evaluate the severity of the patient's enlarged prostate symptoms. The AUA Symptom Index is completed by the patient. Questions are based on patient experiences in the past month and are answered on a scale of 0-5 (0 = not at all, 1 = less than one time in 5, 2 = less than half the time, 3 = about half the time, 4 = more than half the time, 5 = almost always). The scores are totaled and ranked as follows: mild (1-7), moderate (8-19), and severe (20-35).|Baseline and 12 Weeks|The evaluable set includes all subjects who have sufficient data to assess the primary efficacy endpoint, and who have no major protocol deviations. Subjects were analyzed according to randomized treatment. Data for 45 subjects was analyzed.||Change in AUA Score From Baseline||Standard Deviation|Mean
792519|NCT00893464|Secondary|C0: Initial Plasma Concentration After Bolus Intravenous Administration|C0 is the plasma drug concentration at time zero following bolus intravenous injection, obtained from the plasma concentration-time curve.|Cycle 1 Days 1 and 15: Predose and at multiple time points (up to 336 hours postdose)|The pharmacokinetic (PK) analysis population included all participants who had sufficient dosing data and ixazomib concentration-time data to permit calculation of PK parameters where Days 1 and 15 assessments were available.||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
792508|NCT00893113|Primary|Change From Baseline Erectile Function Domain of the International Index of Erectile Function|The International Index of Erectile Function (IIEF) is used for the evaluation of male sexual function and diagnostic evaluation of Erectile Dysfunction (ED) severity. There are 5 domains of the IIEF: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. The Erectile Function (EF) domain of the IIEF is used to assess specific key components of ED including ability to achieve penetration and ability to maintain erection sufficient for satisfactory sexual performance. A score of 0-5 is awarded to each question of the IIEF. The EF domain pertains to questions 1, 2, 3, 4, 5, and 15. Scores are totaled and ranges are assigned to results. In the EF domain, a score of 0-30 is possible. The EF scores can be interpreted as follows: 0-6 severe dysfunction, 7-12 moderate dysfunction, 13-18 mild to moderate dysfunction, 19-24 mild dysfunction, and 25-30 no dysfunction.|Baseline and 12 Weeks|The evaluable set includes all subjects who have sufficient data to assess the primary efficacy endpoint, and who have no major protocol deviations. Subjects were analyzed according to randomized treatment. Data for 45 subjects was analyzed.||Change in EF Domain Score from Baseline||Standard Deviation|Mean
792509|NCT00893152|Primary|Qualitative Interviews - Perspectives on Family Involvement in PTSD Treatment|"This is qualitative research. Outcomes were themes raised with regard to content to be included in a multi-family group psychoeducation program for OEF/OIF/OND veterans with PTSD and family members."|During the 1-1.5 hour interviews|Participants in focus group or individual qualitative interviews||participants|||Number
792510|NCT00893464|Secondary|Overall Best Response|Overall best response is the best response observed for a participant during the study based on International Working Group (IWG) Response Criteria for malignant lymphoma. Complete response (CR) as per IWG is complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. Partial response (PR) is a minimum of 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses and no increase in the size of other nodes. Stable disease (SD) is when a participant fails to attain the criteria needed for a CR or PR, but does not fulfill those for PD. PD is any new lesion or increase by >50% of previously involved sites from nadir.|Baseline up to Cycle 45|Response-evaluable population included participants who received at least 1 dose of study drug, had measurable disease at baseline, and at least 1 postbaseline disease assessment for analyses of response.||participants|||Number
792511|NCT00893464|Secondary|TEmax: Time to Maximum Observed Effect (Emax) for Ixazomib|TEmax: Time to reach the maximum observed effect (Emax), equal to time (hours) to Emax.|Cycle 1 Days 1 and 15: Predose and at multiple time points (up to 168 hours postdose)|The pharmacodynamic analysis population included participants who had sufficient dosing data and effect-time data to permit calculation of pharmacodynamic parameters where Days 1 and 15 assessments were available.||hr||Full Range|Median
792512|NCT00893464|Secondary|Emax: Maximum Observed Effect for Ixazomib|Emax is the maximum inhibition of 20S proteasome activity in whole blood.|Cycle 1 Days 1 and 15: Predose and at multiple time points (up to 168 hours postdose)|The pharmacodynamic analysis population included participants who had sufficient dosing data and effect-time data to permit calculation of pharmacodynamic parameters where Days 1 and 15 assessments were available.||percentage of inhibition||Standard Deviation|Mean
792513|NCT00893464|Secondary|CLr: Renal Clearance|CLr is the volume of plasma from which the drug is completely removed by the kidney in a given amount of time, calculated as the amount of drug excreted in the urine divided by the area under the plasma concentration-time curve, expressed in liter per hour (L/hr).|Cycle 1, Days 1 and 15: 0 to 4 hours postdose|The PK analysis population included all participants who had sufficient dosing data and ixazomib concentration-time data to permit calculation of PK parameters where Days 1 and 15 assessments were available. CLr is not reported for ixazomib 0.125 and 0.25 mg/m^2 as the participants were not evaluable for this parameter.||L/hr||Standard Deviation|Geometric Mean
792514|NCT00893464|Secondary|Fe (0-4): Fraction of Dose Excreted Unchanged in Urine From 0 to 4 Hours Postdose|Fe (0-4) is the fraction of the dose excreted unchanged in the urine from 0 to 4 hours postdose, calculated as percentage of the exact dose administered.|Cycle 1, Days 1 and 15: 0 to 4 hours postdose|The PK analysis population was defined as participants who had sufficient dosing data and ixazomib concentration-time data to permit the calculation of PK parameters where Days 1 and 15 assessments were available.||percentage of dose||Standard Deviation|Geometric Mean
792515|NCT00893464|Secondary|Ae (0-4): Amount of Drug Excreted in Urine From 0 to 4 Hours Postdose|Ae (0-4) is the total amount of drug excreted in the urine from 0 to 4 hours postdose.|Cycle 1, Days 1 and 15: 0 to 4 hours postdose|The PK analysis population included all participants who had sufficient dosing data and ixazomib concentration-time data to permit calculation of PK parameters where Days 1 and 15 assessments were available.||nanogram||Standard Deviation|Geometric Mean
792516|NCT00893464|Secondary|Rac: Accumulation Ratio for Ixazomib|Rac was estimated as the ratio of AUC (0-168) on Day 15 and AUC (0-168) on Day 1. AUC (0-168) is the area under the plasma concentration-time curve from time 0 to 168 hours postdose.|Cycle 1 Days 1 and 15: Predose and at multiple time points (up to 168 hours postdose)|The PK analysis population included all participants who had sufficient dosing data and ixazomib concentration-time data to permit calculation of PK parameters. Rac is reported for ixazomib 1.4, 2.34 and 3.11 mg/m^2 groups only as it could not be estimated for the other dosing groups.||ratio||Standard Deviation|Geometric Mean
792517|NCT00893464|Secondary|Terminal Phase Elimination Half-life (T1/2) for Ixazomib|Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.|Cycle 1 Day 15: Predose and at multiple time points (up to 336 hours postdose)|The PK analysis population included all participants who had sufficient dosing data and ixazomib concentration-time data to permit calculation of PK parameters.T1/2 is not reported for ixazomib 0.125 and 0.25 mg/m^2 as the participants were not evaluable for this parameter.||hr||Standard Deviation|Geometric Mean
792518|NCT00893464|Secondary|AUC(0-168): Area Under the Plasma Concentration-Time Curve From Time 0 to 168 Hours Postdose for Ixazomib|AUC(0-168) is a measure of the area under the plasma concentration time-curve from time 0 to 168 hours postdose|Cycle 1 Days 1 and 15: Predose and at multiple time points (up to 168 hours postdose)|The PK analysis population included all participants who had sufficient dosing data and ixazomib concentration-time data to permit calculation of PK parameters where Days 1 and 15 assessments were available. AUC(0-168) is not reported for ixazomib 0.125 and 0.25 mg/m^2 as the participants were not evaluable for this parameter.||hour*nanogram per milliliter (hr*ng/mL)||Standard Deviation|Geometric Mean
792520|NCT00893464|Primary|Recommended Phase 2 Dose (RP2D)|The RP2D of Ixazomib was determined in Part 1 (dose escalation) on the basis of the totality of safety, tolerability, pharmacokinetics (PK), pharmacodynamic and preliminary efficacy data observed in Cycles 1 and 2 and beyond.|Baseline up to Treatment Cycle 45|Safety population included all participants who received at least 1 dose of ixazomib.||mg/m^2|||Number
792521|NCT00893464|Primary|Maximum Tolerated Dose (MTD)|The MTD was defined as the highest dose of ixazomib that generated dose limiting toxicity (DLT) during Cycle 1 in 0 of 3 or 1 of 6 participants. DLT defined as any of the following considered possibly related to therapy by investigator: Grade 4 neutropenia (absolute neutrophil count [ANC] <500 cell per cubic millimeter [cells/mm^3]) for >7 days; Grade 3 neutropenia with fever or infection; Grade 4 thrombocytopenia for >7 days; platelet count <25,000 cells/mm^3; Grade 3 thrombocytopenia with clinically significant bleeding; platelet count <10,000/mm^3; Grade 2 peripheral neuropathy with pain or Grade 3 peripheral neuropathy; >=Grade 3 nausea/emesis, diarrhea controlled by maximal supportive therapy; Grade 3 QTc prolongation>500 millisecond (msec);any >=Grade 3 nonhematologic toxicity except arthralgia/myalgia; <1 week fatigue; delay in the initiation of the subsequent therapy cycle by >=7 days ; other Grade 2 ixazomib-related nonhematologic toxicities requiring therapy discontinuation.|Treatment Cycle 1|DLT-Evaluable Population included participants who received all Cycle 1 doses of MLN9708 and who completed Cycle 1. If Cycle 1 was interrupted by a DLT, the participant was included in this population.||mg/m^2|||Number
792522|NCT00893464|Primary|Number of Participants With Clinically Significant Change From Baseline in Vital Signs|Vital signs included body temperature, weight, systolic and diastolic blood pressure and heart rate.|Baseline and Days 1, 8, 15 of each treatment cycle up to 45 treatment cycles|Safety population included all participants who received at least 1 dose of ixazomib.||participants|||Number
792523|NCT00893464|Primary|Number of Participants Reporting at Least 1 TEAE Related to Laboratory Assessments|The number of participants with any markedly abnormal standard safety laboratory values collected throughout study. Hematology, clinical chemistry and urinalysis were performed. TEAEs related to laboratory assessment observed at any time-points were reported under 3 system organ classes: blood and lymphatic system disorders, metabolism and nutrition disorders, and investigations.|Baseline and Days 1, 8, and 15 of each treatment cycle (up to Cycle 45)|Safety population included all participants who received at least 1 dose of ixazomib.||participants|||Number
792524|NCT00893464|Primary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event.|Baseline up to 30 days after last dose of study drug|Safety population included all participants who received at least 1 dose of ixazomib.||participants|||Number
792525|NCT00893737|Primary|Change in Scores From Completeness of Response Survey (CORS)|"CORS scores for Pain (0-4), Associated Symptoms (0-4), Limbic/Affective Symptoms (0-5), and Speed of Return to Functionality (1-5), represent outcome measures that are relevant to patients. Higher scores represent better treatment efficacy.
The analysis compares CORS scores for usual triptan (pre-study) versus (vs.) Treximet (study medication)."|Visit 1 (screening) and Visit 2 (study completion following 2-month treatment period)|||Units on a scale||95% Confidence Interval|Mean
792526|NCT00893737|Secondary|Paired T-test Indicating Greater Subject Satisfaction With Treximet Over Usual Pre-study Triptan as Determined by the Revised Patient Perception of Migraine Questionnaire (PPMQ-R)|Scores calculated for (1) Efficacy (2) Functionality (3) Ease of use (4) Cost. Higher score represents better treatment satisfaction.|Visit 1 (screening) and Visit 2 (study completion following 2-month treatment period)|||Units on a scale||95% Confidence Interval|Mean
792527|NCT00893737|Secondary|Percent of Participants Reporting Treximet Provides Therapeutic Advantage Over Usual Pre-study Triptan|CORS completed at Visit 1 regarding participant pre-study triptan and at Visit 2 regarding Treximet taken in study. Areas of therapeutic advantage evaluated: How often does 1 dose completely relieve (1) headache pain (2) neck/shoulder pain (3) nausea (4) light sensitivity (5) sound sensitivity (6) irritability. How quickly can/do you (1) concentrate or think clearly (2) resume normal activities (3) function normally (4) feel completely normal. How confident are you that (1) one dose will completely relieve migraine within 2 hours (2) once relieved, migraine will not return within 24 hours.|Visit 1 (screening) and Visit 2 (study completion following 2-month treatment period)|||Percent of Participants|||Number
792528|NCT00893763|Secondary|Serum Procalcitonin||5 days||||||
792529|NCT00893763|Secondary|Serum Cytokines||5 days||||||
792530|NCT00893763|Secondary|Endotracheal Tube Colonization|semiquantitative swab culture for potentially pathogenic organisms of distal end of the endotracheal tube (ETT) interior lumen at extubation. Results were collapsed into two categories: colonization (moderate or many organisms) or no colonization.|24 hours|The subjects analyzed were a subset of subjects enrolled in the study from whom endotracheal tunes were obtainable for microbial culture post-intubation. Subset analysis was planned a priori.||percentage of ET tubes colonized|||Number
792531|NCT00893763|Primary|Development of VAP (Clinical Pulmonary Infection Score)|Change between post-intervention CPIS and baseline CPIS. Serial prospective evaluation of VAP risk. 6 elements of CPIS (tracheal secretions, temperature, white blood count, oxygenation, chest radiograph, and tracheal aspirate culture) summed to yield total score of 0-12 daily; higher score reflects greater likelihood of VAP.|Baseline up to 5 days|Subjects who had complete CPIS data on admission to the study (Day 0) and subsequent complete CPIS data from day 2, 3, 4 or 5 (47 CHX & 47 control, 438 observations) were included in the analysis in accordance with intent to treat analysis principles.||units on a scale||Standard Error|Mean
792567|NCT00893971|Primary|Spirometry Change From Baseline|Change from baseline for spirometery measures 12-hours post-dose|12 hours|Safety population||Liters||Full Range|Mean
792568|NCT00893971|Primary|ECG Change From Baseline|Change from baseline for ECG parameters 12-hours post-dose|12 hours|Safety population||ms||Full Range|Mean
792532|NCT00893789|Secondary|Physical Examination Findings Shifts From Baseline to Endpoint (Last Postbaseline Observation, up to Week 12)|Number of participants with shifts from normal/abnormal physical examination findings at baseline (BL) to (→) normal/abnormal findings at endpoint (EP, defined as last postbaseline observation, up to Week 12). Shifts (normal and abnormal) from baseline to endpoint are summarized using participant counts for each physical examination category. A newly diagnosed finding was defined as being normal or missing at baseline and abnormal at least once during the study. Any physical examination finding that was judged by the investigator as a clinically significant change (worsening) compared to a baseline value was considered an adverse event. HEENT=head, eyes, ears, nose, throat.|Baseline through Endpoint (last postbaseline observation, up to Week 12)|For each category, only participants in the Safety Analysis Set with a baseline and postbaseline measurement are summarized.||participants|||Number
792533|NCT00893789|Secondary|Electrocardiogram (ECG) Findings Shifts From Baseline to Overall|Number of participants with shifts from normal/abnormal 12-lead ECG findings at baseline (BL) to (→) normal/abnormal findings overall are presented. For overall, the worst postbaseline finding (the abnormal finding if there are both normal and abnormal findings) for the participant between baseline and endpoint (defined as last postbaseline observation, up to Week 12) is summarized. Shifts (normal and abnormal) from baseline to overall are summarized using participant counts. Any ECG finding that was judged by the investigator as a clinically meaningful change (worsening) compared to baseline was recorded as an adverse event.|Baseline through Endpoint (last postbaseline observation, up to Week 12)|Participants in the Safety Analysis Set with a baseline and postbaseline measurement are summarized.||participants|||Number
792534|NCT00893789|Secondary|Number of Participants With Notable Blood Pressure Values Per World Health Organization Criteria|Criteria for World Health Organization (WHO) notable blood pressure (BP) values: systolic blood pressure, ≥140 mm Hg plus increase of ≥10% from baseline; diastolic blood pressure, ≥90 mm Hg plus increase of ≥10% from baseline.|Baseline, last postbaseline observation up to Week 12|Participants in the Safety Analysis Set with a baseline and postbaseline measurement.||participants|||Number
792535|NCT00893789|Secondary|Number of Participants With Clinically Significant Abnormal Vital Sign Values|Criteria for clinically significant abnormal vital signs values: heart rate, ≤50 beats per minute (bpm) and decrease from baseline of ≥15 bpm; sitting systolic blood pressure, ≤90 mm Hg and decrease from baseline of ≥20 mm Hg; sitting diastolic blood pressure, ≤50 mm Hg and decrease from baseline of ≥15 mm Hg.|Baseline, last postbaseline observation up to Week 12|Participants in the Safety Analysis Set with a baseline and postbaseline measurement.||participants|||Number
792536|NCT00893789|Secondary|Number of Participants With Clinically Significant Abnormal Postbaseline Urinalysis Values|Participants with at least one clinically significant postbaseline urinalysis abnormality, specifically presented is blood (hemoglobin) in urine >=2 units increase from baseline.|Baseline, last postbaseline observation up to Week 12|Participants in the Safety Analysis Set with a baseline and postbaseline measurement.||participants|||Number
792537|NCT00893789|Secondary|Number of Participants With Clinically Significant Abnormal Postbaseline Hematology Values|Normal ranges for hematology values: white blood cell (WBC) count, 3.8 - 10.7 x 10^9/L; absolute neutrophil count (ANC), 1.96 - 7.23 x 10^9/L. Participants may have had more than one clinically significant abnormal value.|Baseline, last postbaseline observation up to Week 12|Participants in the Safety Analysis Set with a baseline and postbaseline measurement.||participants|||Number
792538|NCT00893789|Secondary|Number of Participants With Clinically Significant Abnormal Postbaseline Serum Chemistry Values|Normal ranges for serum chemistry values: blood urea nitrogen (BUN), 1.43 - 8.57 mmol/L; uric acid, 124.91 - 493.68 μmol/L; aspartate aminotransferase (AST), 11 - 36 U/L; gamma-glutamyl transpeptidase (GGT), 10 - 61 U/L; total bilirubin, 3.42 - 20.52 μmol/L.|Baseline, last postbaseline observation up to Week 12|Participants in the Safety Analysis Set with a baseline and postbaseline measurement.||participants|||Number
792539|NCT00893789|Secondary|Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Withdrawals Due to AEs|AE=any untoward medical occurrence in a patient that develops or worsens in severity during the conduct of the clinical study of a pharmaceutical product and does not necessarily have a causal relationship to the study drug. SAE=any AE that resulted in any of the following: death; a life-threatening adverse event; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; a congenital anomaly or birth defect; an important medical event that required medical intervention to prevent 1 of the outcomes listed in this definition. Treatment-related AEs=definite, probable, possible, or missing relationship. Protocol-defined AEs=treatment-emergent adverse events associated with skin rash, hypersensitivity reaction, emergent suicidal ideation or suicide attempt, depression, psychosis (including hypomanic or manic episode), and seizure or suspected seizure were considered to be of potential clinical importance.|Screening through Week 12|Safety Analysis Set (all participants who received 1 or more doses of study drug).||participants|||Number
792540|NCT00893789|Secondary|Concomitant Medication Usage In ≥5% of Participants Throughout the Study|Therapeutic classification of concomitant medications used by ≥5% of participants throughout the study. Participants are counted only once in each therapeutic class category. Medications were included in the table if the proportion of participants in the combined armodafinil treatment group was ≥5%.|Screening through Week 12|All randomized participants||participants|||Number
792541|NCT00893789|Secondary|Plasma Concentrations of Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs) at Weeks 4, 8, and 12 (or Last Postbaseline Observation Up to Week 12)|To evaluate the impact of treatment with armodafinil on the pharmacokinetics of selective serotonin reuptake inhibitors (SSRIs) and serotonin and norepinephrine reuptake inhibitors (SNRIs) (as appropriate), plasma concentrations at weeks 4, 8, and 12 (or last postbaseline observation) were to be assessed.|Weeks 4, 8, and 12 (or last postbaseline observation, up to Week 12)|Due to the limited samples available for measurement of concentrations of antidepressants in the study, the plasma concentrations of antidepressants were not measured. The planned pharmacokinetic evaluation of the impact of armodafinil treatment on the pharmacokinetics of selective antidepressants was not conducted.|||||
792569|NCT00893971|Primary|ECG Change From Baseline|Change from baseline for ECG parameters 12-hours post-dose Ventricular rate (bpm)|12 hours|Safety population||bpm||Full Range|Mean
792570|NCT00893971|Primary|Vital Sign Change From Baseline, SpO2|Vital Sign Change from baseline 12-hours post-dose SpO2 (%)|12 hours|All subjects in the Safety Population that had a valid measurement for the parameter||% blood oxygen saturation level||Full Range|Mean
792542|NCT00893789|Secondary|Change From Baseline in the Total Sleep Time As Assessed by Nocturnal Polysomnography (NPSG) at Weeks 2, 4, 12 and Endpoint (Last Postbaseline Observation Up to 12 Weeks)|NPSG continuously records normal and abnormal physiological activity during an entire night. It documents the adequacy of sleep, including the frequency, duration, and total amounts of stage 1-2, stage 3-4 (slow wave sleep), and rapid eye movement (REM) sleep.|Baseline, Weeks 2, 4, 12, and Endpoint (last postbaseline observation up to 12 weeks)|Safety Analysis Set (all participants who received 1 or more doses of study drug); n=number of participants with data at given time point.||minutes||Standard Deviation|Mean
792543|NCT00893789|Secondary|Change From Baseline in the Total Score From the Self-Reported Hamilton Depression Rating Scale, 6 Item Version (S-HAM-D6) at Weeks 2, 4, 8, 12 and Endpoint (Last Postbaseline Observation Up to 12 Weeks)|"The self-reported S-HAM-D6 is a validated scale developed from the core depressive items of the 17 Item Hamilton Depression Inventory (HAM-D17). The HAM-D6 (Items 1, 2, 7, 8, 10, 13 from the 17-item HAMD) evaluates core symptoms of Major Depressive Disorder (MDD). The assessment consists of 6 items representing depressed mood, guilt, work and activities, retardation, psychic anxiety, and general somatic symptoms. Each item is evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). Total scores range from 0 (normal) to 22 (severe). Scores greater than 12 indicate moderate to severe depression and scores less than 12 indicate mild depression."|Baseline, Weeks 2, 4, 8, 12, and Endpoint (last postbaseline observation up to 12 weeks)|Participants in the Safety Analysis Set (participants who received 1 or more doses of study drug) with a baseline S-HAM-D6 measurement; n=number of participants with nonmissing data at given time point.||units on a scale||Standard Deviation|Mean
792544|NCT00893789|Secondary|"Percentage of Participants Answering No to All Questions on the Columbia-Suicide Severity Rating Scale Since Last Visit Version (C-SSRS SLV) at Weeks 2, 4, 8, 12 and Endpoint (Last Postbaseline Observation Up to Week 12)"|The C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors since last visit (SLV). The number of participants answering 'no' to all 9 yes/no questions about suicidal behaviors, ideations, and acts are presented. Questions included the presence of the following: a wish to be dead; nonspecific active suicidal thoughts; actual suicide attempt; non-suicidal self-injurious behavior; interrupted attempt; aborted attempt; suicidal behavior; preparatory suicidal acts or behavior; and completed suicide.|Weeks 4, 8, 12 and Endpoint (last postbaseline observation up to Week 12)|Safety analysis set (all participants who received 1 or more doses of study drug); n=all participants with a nonmissing value at given time point.||percentage of participants|||Number
792545|NCT00893789|Secondary|Change From Baseline in Epworth Sleepiness Scale (ESS) at Week 12 and Endpoint (Last Postbaseline Observation Up to Week 12)|The patient’s evaluation of excessive daytime sleepiness was measured by the ESS. The ESS score is based on responses to questions referring to 8 everyday situations (eg, sitting and reading, talking to someone, being stopped in traffic) and reflects a patient’s propensity to fall asleep in those situations. The ESS score is derived from the sum of the values from questions corresponding to the 8 situations. Scores for the ESS range from 0 to 24, with a higher score indicating a greater daytime sleepiness. This test was self-administered.|Baseline, Week 12, Endpoint (last postbaseline observation, up to Week 12)|Full Analysis Set (all participants who received 1 or more doses of study drug with ≥1 postbaseline primary efficacy assessment); n=number of participants with data at given time point.||units on a scale||Standard Deviation|Mean
792546|NCT00893789|Secondary|Change From Baseline in Traumatic Brain Injury - Work Instability Scale (TBI-WIS) Total Score At Weeks 4, 8, 12 and Endpoint (Last Postbaseline Observation Up to Week 12)|The TBI-WIS is a validated participant-rated instrument for assessing a participant’s functional ability after TBI and the functional demands of their job. The assessment consists of 36 questions to which the participant responded with a “true” or “not true” answer. To score the questionnaire, the number of “true” responses is counted: if < 2, the risk is low; 2 to 23, the risk is medium; and >23, the risk is high, for work instability. Score range is 0 (lowest risk for work instability) to 36 (highest risk for work instability).|Weeks 4, 8, 12 and Endpoint (last postbaseline observation up to Week 12)|Participants in the Full Analysis Set (participants who received 1 or more doses of study drug with ≥1 postbaseline primary efficacy assessment) with a baseline TBI-WIS measurement; n=number of participants with values at given time points.||units on a scale||Standard Deviation|Mean
792547|NCT00893789|Secondary|Percentage of Responders and Nonresponders According to Clinical Global Impression of Change (CGI-C) Ratings at Weeks 2, 4, 8, and 12|The CGI-C is the clinician’s rating of disease severity as compared with pretreatment, assessed by the Clinical Global Impression of Severity (CGI-S). Severity of illness, as related to excessive sleepiness, was assessed at baseline by the CGI-S, which consists of 7 categories: normal–shows no sign of illness, borderline ill, mildly (slightly) ill, moderately ill, markedly ill, severely ill, and among the most extremely ill. The clinician assessed the change from baseline in the participant’s condition, as related to excessive sleepiness, in response to treatment. The CGI-C uses the following 7 categories and scoring assignments: very much improved, much improved, minimally improved, no change, minimally worse, much worse, and very much worse. Responders were defined as those participants who were considered much or very much improved on the CGI-C. Those in all other categories of the CGI-C were considered nonresponders.|Weeks 2, 4, 8, and 12|Full Analysis Set (all participants who received 1 or more doses of study drug with ≥1 postbaseline primary efficacy assessment); n=number of participants with a nonmissing value at given time point.||percentage of participants|||Number
792548|NCT00893789|Secondary|Change From Baseline in Mean Sleep Latency From the MSLT at Weeks 4, 8, and 12|The MSLT is an objective assessment of sleepiness that measures the likelihood of falling asleep. Four 20-minute (maximum) MSLT naps were performed at 0900, 1100, 1300, and 1500. The participant, dressed in nonconstricting clothes, was instructed to lie quietly and attempt sleep. Each MSLT nap continued until: (a) 3 consecutive 30-second epochs of stage 1 sleep were reached or (b) any single, 30-second epoch of stage 2, 3, 4, or rapid eye movement (REM) sleep was reached. Sleep latency for each nap and average sleep latency for the 4 naps were tabulated. According to clinical protocol for the MSLT, each nap was terminated after 20 minutes if no sleep occurred. Sleep latency was measured as the elapsed time from lights-out to the first epoch scored as sleep. With a 30-second scoring epoch, this criterion was reached when sleep occupied at least 16 seconds of any epoch.|Baseline, Weeks 4, 8, and 12|Full Analysis Set (all participants who received 1 or more doses of study drug with ≥1 postbaseline primary efficacy assessment); n=number of participants with data at given time points.||minutes||Standard Deviation|Mean
792549|NCT00893789|Primary|Percentage of Responders and Nonresponders According to Clinical Global Impression of Change (CGI-C) Ratings at Endpoint (Last Postbaseline Observation Up to Week 12)|The CGI-C is the clinician’s rating of disease severity as compared with pretreatment, assessed by the Clinical Global Impression of Severity (CGI-S). Severity of illness, as related to excessive sleepiness, was assessed at baseline by the CGI-S, which consists of 7 categories: normal–shows no sign of illness, borderline ill, mildly (slightly) ill, moderately ill, markedly ill, severely ill, and among the most extremely ill. The clinician assessed the change from baseline in the participant’s condition, as related to excessive sleepiness, in response to treatment. The CGI-C uses the following 7 categories and scoring assignments: very much improved, much improved, minimally improved, no change, minimally worse, much worse, and very much worse. Responders were defined as those participants who were considered much or very much improved on the CGI-C. Those in all other categories of the CGI-C were considered nonresponders.|Last postbaseline observation up to Week 12|Full Analysis Set (all participants who received 1 or more doses of study drug with ≥1 postbaseline primary efficacy assessment).||percentage of participants|||Number
792550|NCT00893789|Primary|Change From Baseline in Multiple Sleep Latency Test (MSLT) at Endpoint (Last Postbaseline Observation Up to Week 12)|The MSLT is an objective assessment of sleepiness that measures the likelihood of falling asleep. Four 20-minute (maximum) MSLT naps were performed at 0900, 1100, 1300, and 1500. The participant, dressed in nonconstricting clothes, was instructed to lie quietly and attempt sleep. Each MSLT nap continued until: (a) 3 consecutive 30-second epochs of stage 1 sleep were reached or (b) any single, 30-second epoch of stage 2, 3, 4, or rapid eye movement (REM) sleep was reached. Sleep latency for each nap and average sleep latency for the 4 naps were tabulated. According to clinical protocol for the MSLT, each nap was terminated after 20 minutes if no sleep occurred. If a participant did not fall asleep in 20 minutes, his/her sleep latency for that nap was set to 20 minutes. Sleep latency was measured as the elapsed time from lights-out to the first epoch scored as sleep. With a 30-second scoring epoch, this criterion was reached when sleep occupied at least 16 seconds of any epoch.|Baseline, last postbaseline observation up to Week 12|Full Analysis Set (all participants who received 1 or more doses of study drug with ≥1 postbaseline primary efficacy assessment); n=number of participants with measurements at given time point.||minutes||Standard Deviation|Mean
792551|NCT00893971|Primary|Serum Potassium Change From Baseline||12 hours|All subjects in the Safety Population||mmol/L||Full Range|Median
792552|NCT00893971|Secondary|Plasma Formoterol PK Parameters (ke)|Pharmacokinetic parameters for plasma formoterol ke|Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose|Subjects with an evaluable profile for this analyte||1/h||Standard Deviation|Mean
792553|NCT00893971|Secondary|Plasma Formoterol PK Parameters (Cmax)|Pharmacokinetic parameters for plasma formoterol Cmax|Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose|Subjects with an evaluable profile for this analyte||pg/mL||Standard Deviation|Mean
792554|NCT00893971|Secondary|Plasma Formoterol PK Parameters (t1/2)|Various pharmacokinetic parameters for plasma formoterol|Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose|Subjects with an evaluable profile for this analyte||h||Standard Deviation|Mean
792555|NCT00893971|Secondary|Plasma Formoterol PK Parameters (Tmax)|Various pharmacokinetic parameters for plasma formoterol|Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose|Subjects with an evaluable profile for this analyte||h||Standard Deviation|Mean
792556|NCT00893971|Secondary|Plasma Formoterol PK Parameters AUC0-inf (h*pg/mL)|Various pharmacokinetic parameters for plasma formoterol|Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose|Subjects with an evaluable profile for this analyte||h*pg/mL||Standard Deviation|Mean
792557|NCT00893971|Secondary|Plasma Formoterol PK Parameters|Various pharmacokinetic parameters for plasma formoterol|Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose|Subjects with an evaluable profile for this analyte||h*pg/mL||Standard Deviation|Mean
792558|NCT00893971|Secondary|Plasma Glycopyrrolate PK Parameters (ke)|Various pharmacokinetic parameters for plasma glycopyrrolate|Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose|Subjects with an evaluable profile for this analyte||1/h||Standard Deviation|Mean
792559|NCT00893971|Secondary|Plasma Glycopyrrolate PK Parameters Cmax (pg/mL)|Various pharmacokinetic parameters for plasma glycopyrrolate|Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose|Subjects with an evaluable profile for this analyte||pg/mL||Standard Deviation|Mean
792560|NCT00893971|Secondary|Plasma Glycopyrrolate PK Parameters (t1/2)|Various pharmacokinetic parameters for plasma glycopyrrolate|Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose|Subjects with an evaluable profile for this analyte||h||Standard Deviation|Mean
792561|NCT00893971|Secondary|Plasma Glycopyrrolate PK Parameters (Tmax)|Various pharmacokinetic parameters for plasma glycopyrrolate|Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose|Subjects with an evaluable profile for this analyte||h||Standard Deviation|Mean
792562|NCT00893971|Secondary|Plasma Glycopyrrolate PK Parameters AUC0-inf (h*pg/mL)|Various pharmacokinetic parameters for plasma glycopyrrolate|Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose|Subjects with an evaluable profile for this analyte||h*pg/mL||Standard Deviation|Mean
792563|NCT00893971|Secondary|Plasma Glycopyrrolate PK Parameters|Various pharmacokinetic parameters for plasma glycopyrrolate|Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose|Subjects with an evaluable profile for this analyte||h*pg/mL||Standard Deviation|Mean
792564|NCT00893971|Primary|Spirometry Change From Baseline|Change from baseline for spirometery measures 12-hours post-dose PEFR (L/min)|12 hours|Safety population||L/min||Full Range|Mean
792565|NCT00893971|Primary|Spirometry Change From Baseline|Change from baseline for spirometery measures 12-hours post-dose FEV/FVC (%)|12 hours|Safety population||Ratio||Full Range|Mean
792566|NCT00893971|Primary|Spirometry Change From Baseline|Change from baseline for spirometery measures 12-hours post-dose (FEV1 % predicted)|12 hours|Safety population||% predicted||Full Range|Mean
792573|NCT00893971|Primary|Hematology Change From Baseline|Hematology assessments taken throughout the study Hemoglobin|24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects|All subjects in the Safety Population that had a valid measurement for the parameter||g/L||Full Range|Mean
792574|NCT00893971|Primary|Hematology Change From Baseline|Hematology assessments taken throughout the study|24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects|All subjects in the Safety Population that had a valid measurement for the parameter||(10^9 cells/L)||Full Range|Mean
792575|NCT00893971|Primary|Hematology Change From Baseline|Hematology assessments taken throughout the study Hematocrit|24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects|All subjects in the Safety Population that had a valid measurement for the parameter||% of Red Blood Cells in the blood||Full Range|Mean
792576|NCT00893971|Primary|Blood Chemistry Change From Baseline|Series of 11 blood chemistries assessed throughout the study|24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects|All patients in the Safety Population that had a valid measurement for the parameter||U/L||Full Range|Mean
792577|NCT00893971|Primary|Blood Chemistry Change From Baseline|Series of 11 blood chemistries assessed throughout the study|24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects|All subjects in the Safety Population that had a valid measurement for the parameter||µmol/L||Full Range|Mean
792578|NCT00893971|Primary|Blood Chemistry Change From Baseline|Series of 11 blood chemistries assessed throughout the study|24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects|All patients in the Safety Population that had a valid measurement for the parameter||mmol/L||Full Range|Mean
792579|NCT00893971|Primary|Symptoms of Tremor|Number of participants reporting tremor at 12 hours post-dose|12 hours|All subjects in the Safety Population||Participants|||Number
792580|NCT00893971|Primary|Symptoms of Dry Mouth|Number of participants reporting dry mouth at 12 hours post-dose|12 hours|All subjects in the Safety Population||Participants|||Number
792581|NCT00893997|Primary|Number of Patients With Clinical Response|Clinical response based on the International Working Group (IWG) Response Criteria in myelodysplastic syndromes (MDS): 'Complete Response' or Hematologic Improvement' and 'No Clinical Response'. Clinical responses as assessed by standard criteria with bone marrow biopsy, cytogenetic studies (standard chromosome banding) and molecular studies 3 weeks after the last vaccination.|At 29 weeks|Analysis on patients treated; study terminated early.||participants|||Number
792582|NCT00893997|Primary|Patient Immunologic Response|Patients assessed after 4th vaccination for immunologic response categorized as 'Immunologic-Responders' or 'Non-Responders.' Immune response defined as an increase of ≥ 0.5 PR1-HLA-A2 tetramer cells/μl compared to the pre study absolute PR1-HLA-A2 tetramer cells/μl. Time period 29 weeks after study entry, with week 0 corresponding to 1st injection, and 8th injection thus being given at week 25, 29 weeks corresponds to 13 weeks after receipt of a 4th injection.|29 weeks|Analysis on patients treated; study terminated early.||participants|||Number
792583|NCT00894127|Primary|Determine the Clinical Sensitivity and Specificity of the Biomoda CyPath™ Early Lung Cancer Detection Assay Using Sputum Specimens From Two Cohorts of Participants and Estimate the Required Sample Size to Finalize a Protocol for a Pivotal Study.|"Various measurements were taken to report the validity of the findings. Sensitivity in this study was defined as the percentage of tumor cells that were positively identified. Specificity was the percentage of true positive signals and accuracy calculated as the percentage of those patients identified as having cancer.
Testing for the study was performed at multiple locations to assess the efficacy of the CyPath Assay to detect lung cancer cells exfoliated from lung tumors present in deep-lung sputum. Participants who satisfied the inclusion/exclusion criteria were enrolled in the study and assigned to one of two cohorts (smoker with clear Low dose CT scan or high-risk normals, and lung cancer confirmed by pathology or cancer)."|March 2011|||percentage|||Number
792584|NCT00887679|Secondary|Changes From Randomization to End of Treatment in Scores on the Sheehan Disability Scores (SDS)|"Scoring:
Participants rate the extent to which work, social life, and home life are impaired by his or her symptoms. A 10 point scale is used where 0= not impaired and 10 is highly impaired indicating. The three aspects of life can be summed up into a single dimensional measure of global functional impairment that indicates 0= not impaired and 30 = highly impaired. Scores of 5 or greater are on any of the three scales are considered significant."|baseline and 7 weeks|||units on a scale||Standard Deviation|Mean
792585|NCT00887679|Secondary|Changes From Randomization to End of Treatment in Scores on the Mini Mental State Examination (MMSE)|Mini Mental State Examination (MMSE),a low score less than or equal to 23 indicates cognitive impairment and the need for further evaluation; normal cognitive function = 27-30, mild cognitive impairment = 21-26, moderate cognitive impairment = 11-20, and severe cognitive impairment = 0-10. The highest possible score is 30.|baseline and 7 weeks|||units on a scale||Standard Deviation|Mean
792586|NCT00887679|Secondary|Change From Randomization to End of Treatment for Trail Making Tet (TMT)|"Trail Making Test (TMT)Results for TMT are reported as the number of seconds required to complete the task. Higher scores reveal greater impairment.
Average =29 seconds, Deficient > 78 seconds"|baseline to 7 weeks|||seconds||Standard Deviation|Mean
792587|NCT00887679|Secondary|Change From Randomization to End of Treatment in Scores for the Clinical Global Impression(CGI-S and CGI-I)|"Scale for scoring:
Clinical Global Impression(CGI-S)
= Normal, no symptoms
= Borderline ill
= Mildly ill
= Moderately ill
= Markedly ill
= Severely ill
= Most extremely ill
Clinical Global Impression(CGI-I)-improvement since treatment
very much improved
much improved
minimally improved
no change from baseline
minimally worse
much worse
very much worse"|baseline and 7 weeks|3 patients dropped out, 4 patients did not meet criteria, and 3 patients did not show up.||scores on a scale||Standard Deviation|Mean
792588|NCT00887679|Primary|Changes From Randomization to End of Treatment in Scores on the Beck Depression Inventory|"Scoring
The BDI consist of twenty-one questions about how the subject has been feeling in the last week. Each question has a set of at least four possible answer choices, ranging in intensity as follows:
(0) I do not feel sad.
I feel sad.
I am sad all the time and I can't snap out of it.
I am so sad or unhappy that I can't stand it.
A value of 0 to 3 is assigned for each answer and the total score is compared to a key to determine the depression's severity. The standard cut-offs are as follows:[6] 0–9: indicates minimal depression 10–18: indicates mild depression 19–29: indicates moderate depression 30–63: indicates severe depression.
Higher total scores indicate more severe depressive symptoms."|baseline and 7 weeks|||units on a scale||Standard Deviation|Mean
792589|NCT00887679|Primary|Change From Randomization to End of Treatment in Scores on the Hamilton Anxiety Rating Scale (HAM-A)|The HAM-A is administered by an interviewer who asks a series of questions related to symptoms of anxiety. The interviewer then rates the individual on a five-point scale for each of the 14 items. Seven of the items specifically address psychic anxiety and the remaining seven items address somatic anxiety. The total anxiety score ranges from 0 to 56, lower scores are better. Change from randomization to end of treatment in scores on the Hamilton Anxiety Rating Scale (HAM-A)is measured.|baseline and 7 weeks|3 patients dropped out, 4 patients did not met the criteria, and 3 patients did not show up.||scores on an anxiety scale||Standard Deviation|Mean
792590|NCT00887744|Secondary|Proportion of Patients Having Procedure and/or Device Related Events During the Complete 12 Month Follow-up Period.||From baseline up to 12 months follow up|||Proportion of patients (%)|||Number
792591|NCT00887744|Secondary|Mean Change in Quality of Life Score at 12 Months Compared to Baseline|The quality of life scale covers five dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels (no health problems,moderate health problems,extreme health problems). The distribution of the response of the patients in these five dimensions was to be studied.This descriptive system was converted into a weighted health state index with Min-max score = 0-100 and 100 as most optimal score. If one or more questions are left unanswered, the questionnaire is not scored.|From baseline up to 12 months follow up|||Scores on a scale (1-100)||Standard Deviation|Mean
792592|NCT00887744|Secondary|Mean Percentage Change in Physical Function at 12 Months Compared to Baseline, Using the Zurich Claudication Questionnaire|"The Zurich Claudication Questionnaire – Physical Function score is the unweighted mean of six physical function questions ranging from 1 to 4. The six Physical Function questions ask about walking distance and ability to walk for pleasure, for shopping, and for getting around the house or apartment and from bathroom to bedroom. If more than one item was missing, the scale score was also to be considered as missing. The possible range of this score is 1.0 to 4.0.
The change is calculated as the scores at the later timepoint minus the earlier timepoint expressed in terms of percentage."|From baseline up to 12 months|||Percent Change||Standard Deviation|Mean
792593|NCT00887744|Secondary|Mean Percentage Change in Symptom Severity at 12 Months Compared to Baseline, Using the Patient Completed Zurich Claudication Questionnaire for Symptom Severity|"The Zurich Claudication questionnaire - Symptom Severity score is based on seven questions (overall pain,pain frequency,pain in the back,pain in the leg,numbness,weakness,and balanced disturbance.The first 6 categories are scored 1 to 5 (none,mild,moderate, severe,very severe). Balance disturbance is scored in a 1-3-5 scale (None,sometimes,often).This score is the unweighted mean of all answered items (missing scores are discarded). Scoring range= 1-5.
The change is calculated as the scores at the later timepoint minus the earlier timepoint expressed in terms of percentage."|From baseline up to 12 months follow up|||Percent Change||Standard Deviation|Mean
792594|NCT00887744|Primary|The Proportion of Patients Experiencing a Procedure or Device Related Serious Adverse Events During the First 7 Days Starting at the Surgical Procedure|"Adverse events were to be summarized by proportion. All Adverse events occurring within the first 7 days after the surgical procedure were to be analyzed:
Day of the procedure until P+1 (where P refers to the day of the surgical procedure)
P+2 until P+7"|Starting at the surgical procedure till 7 days post-operatively|||Proportion of patients (%)|||Number
792595|NCT00887744|Primary|Mean Percentage Change in Symptom Severity at 6 Weeks Compared to Baseline, Using the Patient Completed Zurich Claudication Questionnaire for Symptom Severity|This score is based on seven questions (overall pain,pain frequency,pain in the back,pain in the leg,numbness,weakness,and balanced disturbance.The first 6 categories are scored 1 to 5 (none,mild,moderate, severe,very severe). Balance disturbance is scored in a 1-3-5 scale (None,sometimes,often).The symptom severity scale score is the unweighted mean of all answered items (missing scores are discarded) in the questionnaire. Scoring range= 1-5.The change is calculated as the scores at the later timepoint minus the earlier timepoint expressed in terms of percentage.|From baseline up to 6 weeks follow-up|Intention-To-Treat: the population of patients who underwent the minimally invasive procedure.||Percent change||Standard Deviation|Mean
792596|NCT00887809|Primary|Overall Objective Response|Overall Objective Response will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1)|6 months|||participants|||Number
792597|NCT00887822|Secondary|Change From Cycle 1 in EORTC QLQ-STO22 Scale Over Time|The EORTC QLQ-STO22 is a gastric cancer quality of life questionnaire. There are 22 questions which comprise 5 scales (dysphagia, pain, reflux symptom, dietary restrictions, and anxiety) and 4 single items (dry mouth, hair loss, taste, body image). Most questions used 4-point scale (1 'Not at all' to 4 'Very much'; 1 question was a yes or no answer). A linear transformation was used to standardize all scores and single-items to a scale of 0 to 100; higher score=better level of functioning or greater degree of symptoms.|From Cycle 1 until disease progression (up to 26 months)|ITT population||scores on scale||95% Confidence Interval|Mean
792598|NCT00887822|Secondary|Change From Cycle 1 in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 36 (QLQ-C30) Scale Over Time|EORTC QLQ-C30 included global health status (GHS)/quality of life (QOL), functional scales (physical, role, cognitive, emotional, and social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulties). Most questions used a 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used a 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores were averaged and transformed to 0-100 scale; a higher score for Global Qol/functional scales=better level of QoL/functioning, or a higher score for symptom scale=greater degree of symptoms.|From Cycle 1 until disease progression (up to 26 months)|ITT population||scores on scale||95% Confidence Interval|Mean
792607|NCT00887822|Secondary|Percentage of Participants With Progression-Free Survival (PFS) Events (Disease Progression/Death)|Progression of disease was defined as at least 20 percent (%) increase in the sum of longest diameters of target lesions compared to the smallest sum of longest diameters on-study and absolute increase of at least 5 millimeters (mm), progression of existing non-target lesions, or presence of new lesions. PFS was defined as the time between randomization and the date of first documented disease progression or death, whichever occurred first, according to Response Evaluation Criteria In Solid Tumors (RECIST).|From randomization until disease progression or death (up to 26 months)|ITT population||percentage of participants|||Number
792599|NCT00887822|Secondary|Percentage of Participants With Disease Control During First-Line Therapy|Disease control was defined as stable disease(SD) for 6 weeks or longer, CR plus PR as assessed by RECIST criteria for participants with measurable disease.CR:disappearance of all TLs & normalization of tumor markers. Pathological lymph nodes must have short axis measures<10 mm. PR:at least 30% decrease in sum of measures(longest diameter for tumor lesions and short axis measure for nodes)of TLs, taking as reference baseline sum of longest diameters.SD:neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression taking as reference smallest sum of longest diameters on study. For participants without measurable disease, clinical benefit rate was defined as no clinical disease progression for >/=6 weeks. Disease progression was defined as at least 20% increase in sum of diameters of TLs compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.|From randomization until disease progression or death (up to 26 months)|ITT population||percentage of participants||95% Confidence Interval|Number
792600|NCT00887822|Secondary|Duration of Response During First-Line Therapy|Duration of response during first-line therapy was defined as the time from when response (CR or PR) was first documented to first documented disease progression or death (whichever occurs first) during first-line therapy. CR: disappearance of all target and non-TLs and normalization of tumor markers. Pathological lymph nodes must have short axis measures <10 mm. PR: at least a 30 % decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of TLs, taking as reference the baseline sum of longest diameters. Duration of response was estimated using Kaplan Meier method. Reported data included censored observations. Participants who did not progress or die after they had had a confirmed response were censored at the date of their last tumor measurement or last follow-up for progression of disease during first line therapy.|From randomization until disease progression or death (up to 26 months)|Measurable disease population||months||95% Confidence Interval|Median
792601|NCT00887822|Secondary|Percentage of Participants With Best Overall Response as Assessed by RECIST During First-Line Therapy|Best overall response during first-line therapy was defined as the occurrence of either a confirmed complete (CR) or a partial response (PR), as assessed by the RECIST criteria. CR: disappearance of all target and non-target lesions (TLs) and normalization of tumor markers. Pathological lymph nodes must have short axis measures less than (<) 10 mm. PR: at least a 30 % decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of TLs, taking as reference the baseline sum of longest diameters.|From randomization until disease progression or death (up to 26 months)|Measurable disease population included all randomized participants who had measurable disease at baseline according to RECIST.||percentage of participants||95% Confidence Interval|Number
792602|NCT00887822|Secondary|Time to Progression|Time to progression was defined as the time between randomization and the first occurrence of disease progression. Progression of disease was defined as at least 20% increase in the sum of longest diameters of target lesions compared to the smallest sum of longest diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. Time to progression was estimated using Kaplan Meier method. Reported data included censored observations. Participants who had not progressed at the time of study completion (including participants who had died before disease progression) or who were lost to follow-up were censored at the date of the last tumor assessment or last follow-up for progression of disease. Participants for whom no post-baseline tumor assessments were available were censored at day of randomization.|From randomization until disease progression or death (up to 26 months)|ITT population||months||95% Confidence Interval|Median
792603|NCT00887822|Secondary|Percentage of Participants With Disease Progression|Progression of disease was defined as at least 20% increase in the sum of longest diameters of target lesions compared to the smallest sum of longest diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.|From randomization until disease progression or death (up to 26 months)|ITT population||percentage of participants|||Number
792604|NCT00887822|Secondary|PFS During First-line Therapy|PFS during first-line therapy was defined as time between randomization and date of first documented disease progression or death, whichever occurred first and only if it occurred no later than 28 days after last intake of any study medication and only if it occurred before start of non-study antineoplastic treatment, according to RECIST. Progression of disease was defined as at least 20% increase in sum of longest diameters of target lesions compared to smallest sum of longest diameters on-study & absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. PFS was estimated using Kaplan Meier method. Reported data included censored observations. Participants who neither progressed nor died in this interval, or who were lost to follow-up were censored at date of last tumor assessment/last follow-up within this time window. Participants for whom no post-baseline tumor assessments were available were censored at day of randomization.|From randomization until disease progression or death (up to 26 months)|ITT population.||months||95% Confidence Interval|Median
792605|NCT00887822|Secondary|Percentage of Participants With PFS Events (Disease Progression/Death) During First-line Therapy|Progression of disease was defined as at least 20% increase in the sum of longest diameters of target lesions compared to the smallest sum of longest diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. PFS during first-line therapy was defined as the time between randomization and the date of first documented disease progression or death, whichever occurred first and only if it occurred no later than 28 days after last confirmed intake of any study medication and before the start of non-study antineoplastic treatment, according to RECIST.|From randomization until disease progression or death (up to 26 months)|ITT population||percentage of participants|||Number
792606|NCT00887822|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time between randomization and the date of first documented disease progression or death, whichever occurred first, according to RECIST. Progression of disease was defined as at least 20% increase in the sum of longest diameters of target lesions compared to the smallest sum of longest diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. PFS was estimated using Kaplan Meier method. Reported data included censored observations. Participants who had neither progressed nor died at the time of study completion or who were lost to follow-up were censored at the date of the last tumor assessment or last follow-up for progression of disease. Participants for whom no post-baseline tumor assessments were available were censored at day of randomization.|From randomization until disease progression or death (up to 26 months)|ITT population||months||95% Confidence Interval|Median
792608|NCT00887822|Primary|Overall Survival|Overall survival was defined as the time between randomization and the date of death due to any cause. Overall survival was estimated using Kaplan Meier method. Reported data included censored observations. Participants for whom no death was captured on the clinical database were censored at the most recent date they were known to be alive. As planned, ad hoc analysis was done for overall survival up to clinical clinical cut-off date of 12 January 2012 (34 months), subsequent to the protocol-defined clinical cut-off date of 13 May 2011 (26 months).|From randomization until death (up to 34 months)|ITT population||months||95% Confidence Interval|Median
792609|NCT00887822|Primary|Percentage of Participants With Event (Death)|Percentage of participants who died due to any cause was reported. As planned, ad hoc analysis was done for overall survival up to clinical cut-off date of 12 January 2012 (34 months), subsequent to the protocol-defined clinical cut-off date of 13 May 2011 (26 months). Overall survival was defined as the time between randomization and the date of death due to any cause.|From randomization until death (up to 34 months)|ITT population||percentage of participants|||Number
792610|NCT00887913|Primary|Improvement in Brightness|"Assess the improvement in brightness of the treated anatomical area using Improvement Scale where higher scores indicate a better outcome.
Improvement is graded by means of photographs taken at baseline vs treatment 3 and baseline vs 6week follow up"|4 week follow up post last treatment|Per protocol, each anatomical area treated was assessed for skin brightness using the Improvement Scale of 0-4 where 0= 0%, 1= 1-25%, 2=26-50%, 3=51-75%, 4= 76-100% based on before and photographs. Maximum value grade is 4 and the minimum value grade is 0.||Scores on a scale|Participants|Standard Deviation|Mean
792611|NCT00887913|Primary|Improvement in Smoothness|"Smoothness of anatomical treated area assessed based on Improvement Scale 0-4.Where higher scores indicate a better outcome.
Improvement is graded by means of photographs taken at baseline vs treatment 3 and baseline vs 6week follow up"|4 weeks follow up post last treatment|Analysis was per protocol, each area treated was graded on its improvement regarding the smoothness of the skin||Scores on a scale|Participants|Standard Deviation|Mean
792612|NCT00887913|Primary|Improvement in Fine Lines|"Improvement of fine lines (wrinkles) assessed per anatomical area treated based on Improvement Scale: 0-4 where higher scores indicate a better outcome.
Improvement is graded by means of photographs taken at baseline vs treatment 3 and baseline vs 6week follow up"|4 week follow up after last treatment|Per protocol each defined anatomical area treated was assessed for improvement according to Improvement Scale- 0-4||Scores on a scale|Participants|Standard Deviation|Mean
792613|NCT00887965|Secondary|Procollagen Type 1 N-terminal Peptide (P1NP)|Procollagen Type 1 N-terminal Peptide is a biochemical marker of bone turnover. Blood samples were drawn for assessment of P1NP levels on either Day 3 or Day 20, within 24 hours of the last dose of the respective tetracycline cycle.|Day 3 or Day 20|All enrolled patients with at least one evaluable biopsy||μg/L||Inter-Quartile Range|Median
792614|NCT00887965|Secondary|C-Telopeptide (CTX-1)|C-Telopeptide is a biochemical marker for bone turnover. Blood samples were drawn for assessment of CTX-1 levels on either Day 3 or Day 20, within 24 hours of the last dose of the respective tetracycline cycle.|Day 3 or Day 20|All enrolled patients with at least one evaluable biopsy||ng/mL||Inter-Quartile Range|Median
792615|NCT00887965|Secondary|Bone Histomorphometry: Mineralization Lag Time|The mineralization lag time is the time interval between osteoid secretion and its subsequent mineralization, in days.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.||days||Inter-Quartile Range|Median
792616|NCT00887965|Secondary|Bone Histomorphometry: Osteoid Volume|Osteoid volume is expressed as a percentage of total bone volume.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.||percentage of total volume||Inter-Quartile Range|Median
792617|NCT00887965|Secondary|Bone Histomorphometry: Activation Frequency|The average time that it takes for a new remodeling cycle to begin on any point on a cancellous surface is called the activation frequency (Ac.f). Activation frequency is calculated as the bone formation rate / wall width.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.||/year||Inter-Quartile Range|Median
792618|NCT00887965|Secondary|Bone Histomorphometry: Formation Period|The formation period is the duration of an interval when a place on the bone surface is actively forming bone. The formation period is calculated as the wall width (thickness of new bone made in one cycle) divided by the mineral apposition rate.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.||days||Inter-Quartile Range|Median
792619|NCT00887965|Secondary|Bone Histomorphometry: Bone Formation Rate - Volume Based|Bone formation rate - volume based (BFR/BV) is the calculated rate at which cancellous bone volume is being replaced annually. BFR/BV is derived from the Mineral Appositional Rate * 365 * (relative mineralizing surface / total bone volume).|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.||percent of bone volume per year||Inter-Quartile Range|Median
792620|NCT00887965|Secondary|Bone Histomorphometry: Bone Formation Rate - Surface Based|Bone formation rate - surface based (BFR/BS) is the calculated rate at which cancellous bone surface is being replaced annually. BFR/BS is derived from the Mineral Appositional Rate * 365 * (relative mineralizing surface /total bone surface).|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.||μm^3 /μm^2 /year||Inter-Quartile Range|Median
792621|NCT00887965|Secondary|Bone Histomorphometry: Adjusted Mineral Apposition Rate|The mineral apposition rate (MAR) is the avarage rate at which new bone mineral is being added on any actively forming surface. Adjusted MAR is calculated as: (average distance between visible labels / labeling interval) * (total mineralizing surface/total bone surface).|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.||μm/day||Inter-Quartile Range|Median
792622|NCT00887965|Secondary|Bone Histomorphometry: Mineral Apposition Rate|The mineral apposition rate (MAR) is the avarage rate at which new bone mineral is being added on any actively forming surface. MAR is calculated as the average distance between visible labels, divided by the labeling interval.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.||μm/day||Inter-Quartile Range|Median
792623|NCT00887965|Secondary|Bone Histomorphometry: Total Mineralizing Surface|Total mineralizing surfaces (MS) include all double and half of single-labeled surfaces. MS is expressed as a percentage of total bone surface.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.||percentage of bone surface||Inter-Quartile Range|Median
792624|NCT00887965|Secondary|Bone Histomorphometry: Double-label Surface|Double-label surface is expressed as a percentage of total bone surface. The presence of double labels indicates that normal bone mineralization was actively occurring over the labeling interval.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.||percentage of bone surface||Inter-Quartile Range|Median
792625|NCT00887965|Secondary|Bone Histomorphometry: Single-label Surface|Single-label surface is expressed as a percentage of total bone surface. The presence of a single label indicates that mineralization was occurring during only one labeling period.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.||percentage of bone surface||Inter-Quartile Range|Median
792626|NCT00887965|Secondary|Bone Histomorphometry: Osteoclast Number - Surface Based|Osteoclast number expressed per bone surface area. Osteoclast number was measured using fluorochrome labeling with tetracyclene and tartrate-resistant acid phosphatase stain (TRAP) staining techniques.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.||1/100 mm||Inter-Quartile Range|Median
792627|NCT00887965|Secondary|Bone Histomorphometry: Osteoclast Number - Length Based|Osteoclast number expressed per mm of bone. Osteoclast number was measured using fluorochrome labeling with tetracyclene and tartrate-resistant acid phosphatase stain (TRAP) staining techniques.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.||1/mm||Inter-Quartile Range|Median
792628|NCT00887965|Secondary|Bone Histomorphometry: Eroded Surface/Bone Surface|Eroded surface is expressed as a percentage of total bone surface.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.||percentage of bone surface||Inter-Quartile Range|Median
792629|NCT00887965|Secondary|Bone Histomorphometry: Wall Thickness|Wall thickness is the average thickness of trabecular bone structural units (BSU) and is used to assess the overall balance between resorption and formation.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.||μm||Inter-Quartile Range|Median
792630|NCT00887965|Secondary|Bone Histomorphometry: Osteoid Width|Osteoid thickness (width; O.Th) is the mean thickness of osteoid seams on cancellous surfaces. O.Th is normally <12.5 µm. Increased O.Th suggests abnormal mineralization (osteomalacia).|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.||μm||Inter-Quartile Range|Median
792631|NCT00887965|Secondary|Bone Histomorphometry: Osteoid Surface|Osteoid surface is expressed as a percentage total bone surface.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.||percentage of bone surface||Inter-Quartile Range|Median
792632|NCT00887965|Secondary|Bone Histomorphometry: Osteoblast - Osteoid Interface|Osteoblast - osteoid interface is calculated as osteoblast surface / osteoid surface * 100.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.||percentage of osteoid surface||Inter-Quartile Range|Median
792633|NCT00887965|Secondary|Bone Histomorphometry: Surface Density|Surface density is calculated by total bone (trabecular) surfaces / total tissue volume.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.||mm^2 /mm^3||Inter-Quartile Range|Median
792634|NCT00887965|Secondary|Bone Histomorphometry: Cortical Width|Cortical width correlates with dual photon absorptiometric (DPX) measurements of bone density.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.||μm||Inter-Quartile Range|Median
792635|NCT00887965|Secondary|Bone Histomorphometry: Trabecular Thickness|Mean trabecular thickness (Tb.Th) is a measure of trabecular structure and is calculated as the reciprocal of total bone (trabecular) surfaces. Tb.Th is reduced by aging and osteoporosis.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.||μm||Inter-Quartile Range|Median
792636|NCT00887965|Secondary|Bone Histomorphometry: Trabecular Separation|Trabecular separation (Tb.Sp) is the mean distance in mm between trabeculae (measured by integrated computer graphics). Tb.Sp increases with trabecular bone loss.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.||μm||Inter-Quartile Range|Median
792637|NCT00887965|Secondary|Bone Histomorphometry: Trabecular Number|Trabecular number (Tb.N) is the number of trabeculae present per lineal mm and is calculated as trabecular bone volume/trabecular thickness. Tb.N is a measure of trabecular connectivity and decreases with bone loss.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.||mm^-1||Inter-Quartile Range|Median
792638|NCT00887965|Secondary|Bone Histomorphometry: Cancellous Bone Volume|Cancellous (trabecular) bone volume (Tb.V) is the relative volume of total cancellous bone measured (TV), expressed as percentage, that is occupied by trabeculae. Cancellous bone volume was measured using Fluorochrome labeling with tetracyclene and tartrate-resistant acid phosphatase stain (TRAP) staining techniques.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry||percentage of total volume||Inter-Quartile Range|Median
792639|NCT00887965|Primary|Number of Participants With Normal/Abnormal Bone Histology|The number of participants with normal/abnormal bone histology as assessed by bone biopsy samples at the central histomorphometric facility. Normal bone histology is characterized by: - normal lamellar bone, - normal mineralization or - osteoid (the organic matrix of bone; young bone that has not undergone calcification). Biopsies with abnormal bone histology are characterized by: - osteomalacia, - marrow fibrosis, - clinically significant marrow abnormality or - woven bone.|25-34 days post-Day 1|All enrolled patients who had at least one evaluable biopsy||Participants|||Number
792640|NCT00887978|Post-Hoc|6-minute Walk Distance by Time Since PAH Diagnosis: 3.6 - 26.4 Years||Baseline and 16 weeks|Subjects who had been diagnosed with PAH for 3.6 to 26.4 years prior to Baseline.||meters||Inter-Quartile Range|Median
792641|NCT00887978|Post-Hoc|6-minute Walk Distance by Years Since PAH Diagnosis: 1.8 - 3.5 Years||Baseline and 16 weeks|Subjects who were diagnosed with PAH between 1.8 and 3.5 years prior to Baseline.||meter||Inter-Quartile Range|Median
792642|NCT00887978|Post-Hoc|6-minute Walk Distance by Time Since PAH Diagnosis: 0.9 - 1.74 Years||16 Weeks|Subjects who had been diagnosed with PAH between 0.9 and 1.74 years prior to Baseline.||meters||Inter-Quartile Range|Median
792643|NCT00887978|Post-Hoc|6-minute Walk Distance by Time to PAH Diagnosis: 0 - 0.9 Years||Baseline and 16 weeks|Subjects who have been diagnosed with PAH between 0 to 0.9 years prior to Baseline.||meters||Inter-Quartile Range|Median
792644|NCT00887978|Post-Hoc|6-minute Walk Test by Background PAH Therapy: ERA + PDE-5i||16 weeks|Subjects receiving both an ERA and a PDE-5i at Baseline.||meters||Inter-Quartile Range|Median
792648|NCT00887978|Secondary|Quality of Life (QoL) Assessment: Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR)|Change in CAMPHOR Scores from Baseline to Week 16. The CAMPHOR is a health related quality of life instrument validated for pulmonary hypertension that assesses impairment (symptoms), disability (activities) and quality of life. The questionnaire is divided into three sections; Symptoms (Scores 0-25; high scores indicate more symptoms), Activity (Score 0-30; low score indicates good functioning)and Quality of Life (0-25; high scores indicate poor QoL). The sum of these scores equates to the Total score (0-80). In the CAMPHOR scores, lower scores indicate improvements.|Baseline and 16 Weeks|Subjects in countries where the CAMPHOR has not been validated in the local language were not included in these analyses. Additionally, only subjects with completed questionnaires at Baseline and Week 16 were analyzed.||units on a scale||Inter-Quartile Range|Median
792649|NCT00887978|Secondary|N-terminal proBNP (NT-proBNP)|Serum N-terminal pro-BNP concentration was assessed at Baseline and Week 16.|Baseline and 16 Weeks|Subjects who were missing Week 16 samples were not included in the analysis.||pg/mL||Standard Deviation|Mean
792650|NCT00887978|Secondary|Dyspnea Fatigue Index|The dyspnea-fatigue index was assessed at Baseline and Week 16. Each of the three components of the dyspnea-fatigue index were rated on a scale 0 to 4, with 0 being the worst condition and 4 being the best condition for each component. The dyspnea-fatigue index is computed by summing the three component scores.|Baseline and 16 Weeks|Subjects without a Dyspnea Fatigue Index score at Baseline were not included in the analysis.||units on a scale||Standard Deviation|Mean
792651|NCT00887978|Secondary|Symptoms of PAH|Symptoms of PAH including fatigue, dyspnea, edema, dizziness, syncope, chest pain and orthopnea were assessed by the physician at Baseline and Week 16. Severity grade values (i.e., 0, 1, 2 or 3) for each symptom were provided each subject. A severity of 0 indicated no symptoms, the maximum severity was 3, indicating severe symptoms. Mean change in symptom severity from Baseline to Week 16 is described.|Baseline and 16 Weeks|Subjects without Baseline assessments of PAH symptoms were not included in the analysis.||units on a scale||Standard Deviation|Mean
792652|NCT00887978|Secondary|World Health Organization (WHO) Functional Class|Class I: No limitation of physical activity. Class II: Slight limitation of physical activity. Class III: Marked limitation of physical activity. Class IV: Inability to carry out any physical activity without symptoms.|Baseline and 16 Weeks|Subjects with a WHO functional class assessment at Week 16||participants|||Number
792653|NCT00887978|Secondary|Borg Dyspnea Score|The Borg dyspnea score is a 10-point scale rating the maximum level of dyspnea experienced during the six-minute walk test (6MWT). The Borg dyspnea score was assessed immediately following the 6MWT. Scores ranged from 0 (for no shortness of breath) to 10 (for the greatest shortness of breath ever experienced).|Baseline and 16 Weeks|All subjects with a Baseline Borg Score were included in the analysis. One subject in the placebo group did not have a Baseline Borg Score recorded.||score||Inter-Quartile Range|Median
792654|NCT00887978|Secondary|Clinical Worsening Assessment|"Definition of clinical worsening included patients who met at least one of the following criteria during the 16 weeks of study:
Death (all causes excluding accident)
Transplantation
Atrial septostomy
Hospitalization as a result of right heart failure
Greater than or equal to a 20% decrease in 6MWD from Baseline (or too ill to walk) AND addition of an inhaled prostacyclin analogue, ERA, or PDE-5i
Initiation of parenteral prostacyclin therapy (i.e., epoprostenol, iloprost, or treprostinil) for the treatment of PAH"|Baseline and 16 Weeks|Intention to treat analysis||number of clinical worsening events|||Number
792655|NCT00887978|Primary|6-minute Walk Distance (6MWD)|"Placebo-corrected change in 6MWD from Baseline to Week 16, correlates with the current clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS).
The 6MWD was to be assessed between 3 and 6 hours after the morning dose of study drug and background therapy(ies)."|Baseline and 16 weeks|Intention to treat analysis||meters||Inter-Quartile Range|Median
792656|NCT00888134|Secondary|Sensitivity and Specificity of Detection of the BRAF V600E Mutation in CTC Using the CTC-chip||Up to 4 years|Samples and data were not collected for this outcome.|||||
792657|NCT00888134|Secondary|Progression-free Survival|Reported as percentage of participants alive and progression free at 4-months. Will be estimated using Kaplan-Meier survival curves. Confidence intervals will be calculated and reported.|4 months|||percentage of participants||95% Confidence Interval|Number
792658|NCT00888134|Secondary|Objective Response Rate in Patients With Non-small Cell Lung Cancers and Colon Cancers|Percentage of participants with either colon cancer or non-small cell lung cancer achieving either complete response (disappearance of all target lesions) or partial response (at least a 30% decrease in the sum of the longest diameter of target lesions, when compared with baseline) using CT (computed tomography) scans.|Up to 4 years|||percentage of participants|||Number
792659|NCT00888134|Secondary|AKT Pathway Activity|Correlation between response to AZD6244 and mutational analysis of AKT pathway (an intracellular signaling pathway important in regulating the cell cycle)|Up to 4 years|Samples and data were not collected for this outcome.|||||
792660|NCT00888134|Primary|Objective Response Rate in Patients With Cancers Other Than Melanoma|Percentage of participants achieving either complete response (disappearance of all target lesions) or partial response (at least a 30% decrease in the sum of the longest diameter of target lesions, when compared with baseline) using CT (computed tomography) scans (which are done every 6 weeks).|4 years|||percentage of participants|||Number
792661|NCT00888238|Secondary|Glucose Infusion Rate (GIR) During 190 – 340 Minutes Post-dose|Glucose Infusion Rate required to maintain the target glucose level of 160 milligrams / deciliter (mg/dL) ; GIR was normalized to subject's body weight (kg).|190 minutes to 340 minutes|All subjects who completed a hyperglycemic clamp in each period were included in the analysis.||mg / kg / min||Standard Deviation|Least Squares Mean
792662|NCT00888238|Primary|Insulin Secretion Rate (ISR) During 190 – 340 Minutes Post-dose|ISR was estimated by the deconvolution of peripheral C-peptide concentrations using a 2-compartment model that utilizes population C-peptide kinetic parameters.|190 minutes to 340 minutes|All subjects who completed a hyperglycemic clamp in each period were included in the analysis.||ng/min||Standard Deviation|Least Squares Mean
792663|NCT00888329|Primary|Number of Participants With Emesis|This is the number of participants who had an episode of vomiting within 24 hours after emergence from anesthesia.|24 hours after emergence from anesthesia|ITT. However, the primary outcome measure was not recorded for 84 participants in the Aprepitant group and 63 participants in the Placebo group.||participants|||Number
792666|NCT00888355|Other Pre-specified|Number of Patients With Serious LAEs|Serious LAEs are any LAEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose|12 weeks|All patients who took study medication and had any laboratory tests performed were included in the analysis.||Participants|||Number
792667|NCT00888355|Other Pre-specified|Number of Patients With Laboratory Adverse Experiences (LAEs)|A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|12 weeks|All patients who took study medication and had any laboratory tests performed were included in the analysis.||Participants|||Number
792668|NCT00888355|Other Pre-specified|Number of Patients Who Died|Patients who died during the 12-week treatment period|12 weeks|All patients who took study medication were included in the analysis.||Participants|||Number
792669|NCT00888355|Other Pre-specified|Number of Patients Discontinued Due to CAEs|Patients discontinued due to CAEs during the 12-week treatment period|12 weeks|All patients who took study medication were included in the analysis.||Participants|||Number
792670|NCT00888355|Other Pre-specified|Number of Patients With Drug-related CAEs|Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs during the 12-week treatment period|12 weeks|All patients who took study medication were included in the analysis.||Participants|||Number
792671|NCT00888355|Other Pre-specified|Number of Patients With Serious CAEs|Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose|12 weeks|All patients who took study medication were included in the analysis.||Participants|||Number
792672|NCT00888355|Other Pre-specified|Number of Patients With Clinical Adverse Experiences (CAEs)|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|12 weeks|All patients who took study medication were included in the analysis.||Participants|||Number
792673|NCT00888355|Secondary|Categories of Antihypertensive Response in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12|Patients with trough SiDBP <90 mm Hg were in Category I, ≥90 but decreased at least 10 mm Hg were in Category II, and ≥90 and decreased less than 10 mm Hg or increased were in Category III.|24 hours after last morning dose and 12 hours after last PM dose at 12 weeks|"An all patients treated approach was employed that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available."||Participants|||Number
792674|NCT00888355|Secondary|Mean Change From Baseline in Peak Sitting Diastolic Blood Pressure (SiDBP) at Week 12|Mean change from baseline in peak (6 hours after the last morning dose) SiDBP at Week 12|At baseline and at 12 weeks (6 hours after last morning dose)|"An all patients treated approach was employed that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available."||mm Hg||Standard Deviation|Mean
792675|NCT00888355|Secondary|Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) as Week 12|Mean change from baseline in trough (24 hours after the last morning dose and 12 hours after the last PM dose) SiSBP at Week 12|At baseline, and at 12 weeks (24 hours after last morning dose and 12 hours after last PM dose)|"An all patients treated approach was employed that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available."||mm Hg||Standard Deviation|Mean
792676|NCT00888355|Primary|Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12|Mean change from baseline in trough (24 hours after the last morning dose and 12 hours after the last PM dose) SiDBP at Week 12|At baseline, and at 12 weeks (24 hours after last morning dose and 12 hours after last PM dose)|"The primary analysis employed an all patients treated approach that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available."||mm Hg||Standard Deviation|Mean
792677|NCT00888381|Secondary|The Incidence of Any Unsolicited Adverse Events (AEs).|"The number of participants reporting any unsolicited adverse events.
Unsolicited adverse event (UAE) grading:
Mild: Symptoms were easily tolerated and did not interfere with normal, everyday activities. Moderate: Enough discomfort to have caused some interference with normal, everyday activities. Severe: Symptoms that prevented normal, everyday activities."|After vaccination until the end of the study; approximately 21 days|The Safety Population comprised all participants who received study vaccine.||participants|||Number
792678|NCT00888381|Secondary|The Frequency of Any Solicited Systemic Symptoms.|The number of participants reporting any solicited systemic symptoms.|During the 4 days after vaccination (Day 0 plus 3 days)|The Safety Population comprised all participants who received study vaccine.||participants|||Number
792679|NCT00888381|Secondary|The Frequency of Any Solicited Local Reactions.|The number of participants reporting any solicited local reactions.|During the 4 days after vaccination (Day 0 plus 3 days)|The Safety Population comprised all participants who received study vaccine.||participants|||Number
792680|NCT00888381|Primary|The Percentage of Evaluable Participants Achieving a HI Titre ≥ 40 or Single Radial Haemolysis (SRH) Area ≥ 25 mm2.||Approximately 21 days after vaccination|The Evaluable Population comprised all participants who were vaccinated with the study vaccine, provided both pre- and post-vaccination antibody titre results, and were not excluded from the analyses (eg, for the use of a prohibited medication or a laboratory-confirmed influenza virus infection between Visits 1 and 2).||percentage of participants||95% Confidence Interval|Number
792681|NCT00888381|Primary|The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination.|GMFI is defined as the geometric mean of the fold increases of post-vaccination antibody titre over the pre-vaccination antibody titre.|Approximately 21 days after vaccination|The Evaluable Population comprised all participants who were vaccinated with the study vaccine, provided both pre- and post-vaccination antibody titre results, and were not excluded from the analyses (eg, for the use of a prohibited medication or a laboratory-confirmed influenza virus infection between Visits 1 and 2).||percentage of participants||95% Confidence Interval|Number
792682|NCT00888381|Primary|The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre.|As per the criteria specified in the CPMP/BWP/214/96 Note for Guidance on Harmonisation of Requirements for Influenza Vaccines. For haemagglutination inhibition (HI), seroconversion is defined as achieving a post-vaccination titre of ≥ 40 for those participants with a pre-vaccination HI titre of < 10; significant increase is defined as a four-fold or greater increase in HI titre for those participants with a pre-vaccination HI titre of ≥ 10.|Approximately 21 days after vaccination|The Evaluable Population comprised all participants who were vaccinated with the study vaccine, provided both pre- and post-vaccination antibody titre results, and were not excluded from the analyses (eg, for the use of a prohibited medication or a laboratory-confirmed influenza virus infection between Visits 1 and 2).||percentage of participants||95% Confidence Interval|Number
792683|NCT00888433|Primary|Office Systolic Blood Pressure Reduction|The primary effectiveness endpoint is change in Office Systolic Blood Pressure (SBP) from baseline to 6 months post-randomization.|Baseline to 6 months|||mmHg||Standard Deviation|Mean
792684|NCT00888459|Primary|Number of Participants With Tobacco Abstinence|self-reported 7-day point prevalence tobacco abstinence at week 12 (end of treatment)|12 weeks|intention to treat||participants|||Number
792685|NCT00894166|Secondary|Continuous Abstinence From Smoking at 6 Months Post Quit.||continuous abstinence at 6 months post quit day|||percentage of subjects|||Number
792686|NCT00894166|Secondary|Abstinence (7 Days) at 6 Months.||point abstinence (7 days) at 6 months post-quit date|||percentage of subjects|||Number
792687|NCT00894166|Primary|Continuous 4-week Abstinence From Smoking Between Weeks 8-11 After the Quit Date (Through the End of Treatment)|A self report of no cigarettes smoked confirmed by expired air carbon monoxide of <=10ppm was the criterion for abstinence.|weeks 8-11 after quit date|All participants were included in the analyses except those dropping out prior to randomization points, those censored for taking contraindicated medications or failing to meet other inclusion criteria, and one death having no apparent relationship to treatment.||percentage of subjects abstinent||95% Confidence Interval|Number
792688|NCT00894244|Primary|The Change in Skin Tightening in the Upper Inner or Outer Arm (as Measured by Millimeters)|The documented variable was shrinkage length in millimeters as measured by the same straight ruler used throughout the experimentation. Measurements were taken immediately following treatment and thirty days following the last treatment|immediately following treatment and 30 days after last treatment|||millimeters||95% Confidence Interval|Number
792689|NCT00894322|Primary|Time to Maximum Concentration (Tmax) of 2 mg Exenatide (Cohort 2) in Participants With Diabetes in Pharmacokinetic Evaluable Population|Cohort 2: Blood samples for the assessment of plasma exenatide were collected on Day 1, Weeks 2, 4, 6, 8, and 10. At Week 10, blood samples were collected at time = -15, 60, 90, 120, 180, 240, and 360 minutes relative to study medication injection at time = 0. Tmax was measured in hours (h). Exenatide was measured using a validated ELISA. Tmax summarized at 0-6 h at Week 10, 0-168 h at Weeks 10-11, and 0-tlast at Weeks 10-12. PK evaluable population consisted of all ITT participants who had at least 4 detectable plasma exenatide measurements (not < LLOQ) from Day 1 to Week 12 and had reliable PK data.|Week 10, Weeks 10-11, Weeks 10-12|PK evaluable population was analyzed. In categories below, n = number of ITT participants with PK evaluable data. Note: Placebo-treated participants not included in this analysis.||hours||Standard Error|Geometric Mean
792690|NCT00894322|Primary|Maximum Concentration (Cmax) for 2 mg Exenatide (Cohort 2) in Participants With Diabetes in the Pharmacokinetic Evaluable Population|Cohort 2: Blood samples for the assessment of plasma exenatide were collected on Day 1, Weeks 2, 4, 6, 8, and 10. At Week 10, blood samples were collected at time = -15, 60, 90, 120, 180, 240, and 360 minutes relative to study medication injection at time = 0. Cmax was measured in pg/mL. Exenatide was measured using a validated enzyme-linked immunosorbent assay (ELISA). Cmax summarized at 0-6 h at Week 10, 0-168 h at Weeks 10-11, and 0-tlast at Weeks 10-12. PK evaluable population consisted of all ITT participants who had at least 4 detectable plasma exenatide measurements (not < LLOQ) from Day 1 to Week 12 and had reliable PK data.|Week 10, Weeks 10-11, Weeks 10-12|PK evaluable population was analyzed. In categories below, n = number of ITT participants with PK evaluable data. Note: Placebo-treated participants not included in this analysis.||pg/mL||Standard Error|Geometric Mean
792691|NCT00894322|Primary|Average Exenatide Concentration (Cave) of 2 mg Exenatide (Cohort 2) in Participants With Diabetes in the Pharmacokinetic Evaluable Population|Cohort 2: Blood samples for the assessment of plasma exenatide were collected on Day 1, Weeks 2, 4, 6, 8, and 10. At Week 10, blood samples were collected at time = -15, 60, 90, 120, 180, 240, and 360 minutes relative to study medication injection at time = 0. At all visits following the single injection, a single blood sample was collected for assessment of exenatide concentrations. Cave(0-168h) and Cave(0-tlast) was the time-weighted mean concentration over the sampling period from time x to time y corresponding to AUC (0-168h), and AUC (0-tlast), respectively. Cave was measured in picograms per milliliter (pg/mL). Exenatide concentration was measured using a validated enzyme-linked immunosorbent assay (ELISA). PK evaluable population consisted of all ITT participants who had at least 4 detectable plasma exenatide measurements (not < LLOQ) from Day 1 to Week 12 and had reliable PK data.|Week 10 - Week 11; Week 10 - Week 12|PK evaluable population was analyzed. In categories below, n = number of ITT participants with PK evaluable data. Note: Placebo-treated participants not included in this analysis.||pg/mL||Standard Error|Geometric Mean
792710|NCT00894387|Secondary|Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 12 Months|A cardiovascular event defined as CV death, heart faliure re-hospitalization, non-fatal myocardial infarction (MI), nonfatal stroke, sudden death with resuscitation.|12 months|Full analysis set included all randomized patients who had taken at least one dose of study drug.||Participants|||Number
792692|NCT00894322|Primary|Area Under the Curve (AUC) for 2 mg Exenatide (Cohort 2) in Participants With Diabetes in the Pharmacokinetic Evaluable Population|Cohort 2: Blood samples for the assessment of plasma exenatide were collected on Day 1, Weeks 2, 4, 6, 8, and 10. At Week 10, blood samples were collected at time = -15, 60, 90, 120, 180, 240, and 360 minutes relative to study medication injection at time = 0. AUC was measured in picograms * hours per milliliter (pg*hr/mL). Exenatide was measured using a validated enzyme-linked immunosorbent assay (ELISA). AUC calculated using linear trapezoidal method from time x to time y; AUC (0-6h) measured at Week 10, AUC (0-168h) steady state measured between Weeks 10 and 11, and AUC (0-tlast) for time interval between Weeks 10 and 12 (approximately336 hours) are presented below. PK evaluable population consisted of all ITT participants who had at least 4 detectable plasma exenatide measurements (not < LLOQ) from Day 1 to Week 12 and had reliable PK data.|Week 10-11; Weeks 10 - 12|PK evaluable population was analyzed. In categories below, n = number of ITT participants with PK evaluable data. Note: Placebo-treated participants not included in this analysis.||pg*hr/mL||Standard Error|Geometric Mean
792693|NCT00894322|Secondary|Mean Change From Baseline at Week 12 in Fasting Plasma Glucose in Participants With Diabetes (Cohort 2) for the ITT Population|Baseline was the last measurement at the screening visit. Fasting plasma glucose (FPG) was measured at screening, Day 1, Weeks 2, 4, 6, 8, 12, or early termination and reported in milligrams per deciliter (mg/dL).|Baseline, Week 12|ITT population included all participants treated with at least one dose of study drug. Only participants in Cohort 2 were evaluated for this Outcome Measure.||mg/dL||Standard Error|Least Squares Mean
792694|NCT00894322|Secondary|Mean Change From Baseline at Week 12 in Body Weight in Participants With Diabetes (Cohort 2) in the ITT Population|Body weight was measured in kilograms (kg). Baseline was Day 1, last measurement prior to first dose of study drug. Body weight was measured at screening, Day 1, Weeks 4, 8, 12 or early termination and the LOCF approach was applied to estimate missing value at each post baseline timepoint.|Baseline, Week 12|ITT population included all participants treated with at least one dose of study drug. Only Cohort 2 was analyzed for this outcome measure.||kg||Standard Error|Least Squares Mean
792695|NCT00894322|Secondary|Number of Participants Achieving HbA1c Less Than Equal to (<=) 6.5% and Less Than (<) 7% at Week 12 in Participants With Diabetes (Cohort 2) in the ITT Population|HbA1c was measured as a percent of hemoglobin at screening, Day 1, Weeks 4, 8, 12 or early termination. LOCF was applied to estimate missing values at post baseline timepoints. Baseline=Day 1, last measurement prior to first dose of study drug.|Week 12|ITT population included all participants treated with at least one dose of study drug. Only those ITT participants in Cohort 2 were analyzed.||participants|||Number
792696|NCT00894322|Secondary|Least Square Mean Change From Baseline in Hemoglobin A1c (HbA1c) to Week 12 in Participants With Diabetes (Cohort 2) in the ITT Population|HbA1c was measured as a percent of hemoglobin at screening, Day 1, Weeks 4, 8, 12 or early termination. Last observation carried forward (LOCF) was applied to estimate missing values at post baseline timepoints. Baseline=Day 1, last measurement prior to first dose of study drug.|Day 1 to Week 12|ITT population included all participants treated with at least one dose of study drug. This analysis was only done in Cohort 2 so the ITT population of Cohort 2 was available for analysis.||Percent of hemoglobin||Standard Error|Least Squares Mean
792697|NCT00894322|Primary|Antibody Titers for Participants With Treatment Emergent Positive Antibodies to Exenatide in Participants Who Received Exenatide in Cohorts 1 and 2|Serum titers of antibodies to exenatide were evaluated using a validated enzyme-linked immunosorbent assay (Covance Method No. ELISA-0308). Positive antibody to exenatide titer: observed at the indicated visit following a negative or missing titer at baseline, or a positive titer that has increased by at least 3 dilutions at the indicated visit from a detectable baseline. Baseline=Day 1. Negative titers were assigned a value of 1 in order to calculate geometric mean. Geometric mean of reportable titers, by study week, are presented below.|Day 1 to Week 12|Only participants who received exenatide were analyzed (no placebo-treated participants were included). N=number of participants in each treatment at each visit and n= number of participants with reportable titers at the visit. Last visit=last visit with reportable titers.||Reportable Titers||Standard Error|Geometric Mean
792698|NCT00894322|Primary|Number of Participants With Hematology and Serum Chemistry Laboratory Values of Potential Clinical Importance in Cohorts 1 and 2 in ITT Population|Abbreviations: Upper Limit of Normal (ULN); milligram per deciliter (mg/dL); units per liter (U/L); micro liters (µL); creatine kinase (CK); gamma-glutamyltransferase (G-GT). Normal ranges = Hematocrit: 40.6-52.3% (male), 35.3-47.0 (female); Platelets 155-361*10^3/µL(male/female); Calcium: 8.6-10.4 mg/dL (male/female); CK: 43-350 U/L (male), 28-207 U/L (female); G-GT: 7-62 U/L (male/female); Glucose 73-105 mg/dL (male/female); Lipase 14-70 U/L (male/female); Uric acid: 3.5-7.8 mg/dL (male), 2.3-5.9 mg/dL (female). Blood samples for laboratories were collected at screening, Day 1, Weeks 4, 8, 12 or early termination. Value for potential clinical importance is presented in each category presented below.|Day 1 to Week 12|ITT population included all participants treated with at least one dose of study drug.||participants|||Number
792699|NCT00894322|Primary|Mean Change From Baseline to End of Study in Sitting Heart Rate in Cohorts 1 and 2 in ITT Population|In Cohort 1, sitting heart rates were obtained at Screening (Visit 1), Day 1 (Visit 2), Weeks 1-11 (Visits 3-13), Week 12 (Visit 14), and at early termination. Heart rate was measured in beats per minute (bpm). In Cohort 2, sitting heart rates were obtained at Screening (Visit 1), Day 1 (Visit 2), Weeks 1-10 (Visits 3-12), Week 11 (Visit 15), Week 12 (Visit 16) and at early termination. Baseline was defined as last measurement prior to first injection of study drug.|Day 1 to Week 12|||bpm||Standard Deviation|Mean
792700|NCT00894322|Primary|Mean Change From Baseline to End of Study in Sitting Diastolic and Systolic Blood Pressure in Cohorts 1 and 2 in ITT Population|In Cohort 1, sitting blood pressures were obtained at Screening (Visit 1), Day 1 (Visit 2), Weeks 1-11 (Visits 3-13), Week 12 (Visit 14), and at early termination. Blood pressures (diastolic and systolic) were measured in millimeters of mercury (mmHg). In Cohort 2, sitting blood pressures were obtained at Screening (Visit 1), Day 1 (Visit 2), Weeks 1-10 (Visits 3-12), Week 11 (Visit 15), Week 12 (Visit 16) and at early termination. Baseline was defined as last measurement prior to first injection of study drug.|Day 1 to Week 12|ITT population included all participants treated with at least one dose of study drug.||mmHg||Standard Deviation|Mean
792819|NCT00897390|Primary|Metformin PK Parameter AUC(INF)|Single-dose PK parameters of metformin were derived from plasma concentration versus time data.|pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|Treated participants with PK measures||ng*h/mL||Full Range|Geometric Mean
792701|NCT00894322|Secondary|Average Exenatide Concentration (Cave) of 10 mg Exenatide (Cohort 1) in Healthy Participants in the Pharmacokinetic Evaluable Population|Cohort 1: Blood samples for the assessment of plasma exenatide were collected at time = -15, 60, 90, 120, 180, 240, 360, and 480 minutes relative to study medication injection at time = 0 on Day 1. At all visits following the single dose, a single blood sample was collected for assessment of exenatide concentrations. Cave(0-168h) was the time-weighted mean concentration over the sampling period from time x to time y corresponding to AUC (0-168h) and was measured in picograms per milliliter (pg/mL). Exenatide concentration was measured using a validated enzyme-linked immunosorbent assay (ELISA). PK evaluable population consisted of all ITT participants who had at least 4 detectable plasma exenatide measurements [not less than (<) lower limits of quantification (LLOQ)] from Day 1 to Week 12 and had reliable PK data.|Day 1 to Week 1|PK evaluable population.||pg/mL||Standard Error|Geometric Mean
792702|NCT00894322|Secondary|AUC (0 Hour to 168 Hour) for 10 mg Exenatide (Cohort 1) in Healthy Participants in the Pharmacokinetic Evaluable Population|Cohort 1: Blood samples for the assessment of plasma exenatide were collected at time = -15, 60, 90, 120, 180, 240, 360, and 480 minutes relative to study medication injection at time = 0 on Day 1. At all visits following the single injection, a single blood sample was collected for assessment of exenatide concentrations. AUC (0-168 h) data represents average concentration rather than maximum concentration. Exenatide concentration was measured using a validated enzyme-linked immunosorbent assay (ELISA). AUC calculated using linear trapezoidal method from time x to time y and measured in pg*h/mL. PK evaluable population consisted of all ITT participants who had at least 4 detectable plasma exenatide measurements (not < LLOQ) from Day 1 to Week 12 and had reliable PK data.|Day 1 to Week 1|PK evaluable population.||pg*h/mL||Standard Error|Geometric Mean
792703|NCT00894322|Primary|Number of Participants With Concomitant Medications in Cohort 1 and Cohort 2 in ITT Population|Concomitant medications are defined as those medications received on or after the date of the first injection on Day 1, including prior medications that continued past Day 1 and new concomitant medications. Participants may be counted in more than one medication class and no more than once in each class. Categories by Anatomical Therapeutic Chemical (ATC) classification using the World Health Organization (WHO) Drug Dictionary version C1, 01 March 2009. As per protocol, all participants in Cohort 1 could receive up to 2 anti-emetic medications approximately 30 minutes prior to the exenatide.|Day 1 to 12 weeks|ITT population included all participants treated with at least one dose of study drug.||participants|||Number
792704|NCT00894322|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs), Injection Site TEAEs, Serious Adverse Events (SAEs), Deaths, and Withdrawals Due to AEs in Cohort 1 and Cohort 2 in Intent to Treat (ITT) Population|Treatment emergent (TE)=occurs during or after treatment with study drug. Adverse Event (AE)=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Participants experiencing multiple episodes of a given AE are counted once. Injection site AEs: adverse events that existed prior to Day 1 and worsened after the first administration at Day 1, or occurred after the first administration at Day 1 through Week 12, or after Study Termination if considered by investigator to be clinically significant.|Day 1 to Week12|ITT population included all participants treated with at least one dose of study drug.||participants|||Number
792705|NCT00894322|Primary|Time to Maximum Concentration (Tmax) for Single Dose of 10 mg Exenatide (Cohort 1) in Healthy Participants in the Pharmacokinetic Evaluable Population|Cohort 1: Blood samples for the assessment of plasma exenatide were collected at time(t) = -15, 60, 90, 120, 180, 240, 360, and 480 minutes relative to study medication injection at time = 0 on Day 1 an the mean is presented below. At all visits following the single injection, a single blood sample was collected for assessment of exenatide concentrations. Tmax was measured in hours and Tmax (0-8h) and (0-tlast) are presented below. Exenatide concentration was measured using a validated enzyme-linked immunosorbent assay (ELISA). PK evaluable population consisted of all ITT participants who had at least 4 detectable plasma exenatide measurements [not less than (<) lower limits of quantification (LLOQ)] and had reliable PK data.|Day 1, Week 12|PK evaluable population. n=number of participants who had reliable PK data available to be evaluated.||hours||Standard Error|Geometric Mean
792706|NCT00894322|Primary|Maximum Concentration (Cmax) for Single Dose of 10 mg Exenatide (Cohort 1) in Healthy Participants in the Pharmacokinetic Evaluable Population|Cohort 1: Blood samples for the assessment of plasma exenatide were collected at time = -15, 60, 90, 120, 180, 240, 360, and 480 minutes relative to study medication injection at time = 0 on Day 1 and the mean is presented below. At all visits following the single injection, a single blood sample was collected for assessment of exenatide concentrations. Cmax was measured in picograms per milliliter (pg/mL). Exenatide concentration was measured using a validated enzyme-linked immunosorbent assay (ELISA). PK evaluable population consisted of all ITT participants who had at least 4 detectable plasma exenatide measurements [not less than (<) lower limits of quantification (LLOQ)] from Day 1 to Week 12 for the evaluation of the PK characteristics of plasma exenatide and had reliable PK data. Cmax (0-8h) and (0-tlast) are presented below.|Day 1, Week 12|PK evaluable population.||pg/mL||Standard Error|Geometric Mean
792707|NCT00894322|Primary|Area Under the Curve (AUC) for Single Dose of 10 mg Exenatide (Cohort 1) in Healthy Participants in the Pharmacokinetic Evaluable Population|Cohort 1: Blood samples for the assessment of plasma exenatide were collected at time = -15, 60, 90, 120, 180, 240, 360, and 480 minutes relative to study medication injection at time = 0 on Day 1 and the mean is presented below. At all visits following the single injection, a single blood sample was collected for assessment of exenatide concentrations. AUC was measured in picograms * hours per milliliter (pg*hr/mL). Exenatide was measured using a validated enzyme-linked immunosorbent assay (ELISA). AUC calculated using linear trapezoidal method from time x to time y; AUC (0-8h) and (0-tlast) are presented below. Pharmacokinetic (PK) evaluable population consisted of all ITT participants who had at least 4 detectable plasma exenatide measurements [not less than (<) lower limits of quantification (LLOQ)] from Day 1 to Week 12 and had reliable PK data.|Day 1, Week 12|PK evaluable population was analyzed. n in categories below = number of ITT participants with PK evaluable data.||pg*h/mL||Standard Error|Geometric Mean
792708|NCT00894361|Primary|Knee Postoperative Range of Motion (ROM) at 2 Years|range of motion of the knee postoperatively at 2 years|2 years|||degrees||Standard Deviation|Mean
792709|NCT00894361|Secondary|Survival of the Implants to Subject Death or Implant Removal||10 or more years||||||
792711|NCT00894387|Secondary|Change From Baseline in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Level at 1 Month, 6 Months, and 12 Months|The reported Least square means, and Confidential Interval were from a repeated measures model on log transformed NT-proBNP data containing treatment, visit, and region as factors, log baseline NT-proBNP as a continuous covariate and treatment by visit and visit by log baseline NT-proBNP as interaction terms.|Baseline, 1 month, 6 months and 12 months|Full analysis set included all randomized patients who had taken at least one dose of study drug. 'n' in each category indicates patients with assessable date at baseline and each corresponding time point.||pg/mL||95% Confidence Interval|Least Squares Mean
792712|NCT00894387|Primary|Time to Event Analysis: Number of Patients Experienced the First Confirmed Occurrence of Either Cardiovascular Death or Heart Failure (HF) Re-hospitalization Within 6 Months|Time to first confirmed occurrence of either cardiovascular death or heart failure re-hospitalization within 6 months of randomization was the primary efficacy variable. For the primary efficacy analysis, an event will be considered for the analysis if it occurs on or before Day 190 (189 days from randomization). The primary composite endpoint is the the composite of cardiovascular death or heart faliure re-hospitalization within 6 months.|6 months|Full analysis set (FAS) consisted of randomized patients who had received at least one dose of study drug.||Participants|||Number
792713|NCT00894387|Secondary|Time to Event Analysis: Number of Patients With All-cause Mortality Hospitalized for an AHF Event Within 12 Months||12 months|Full ananlysis set included all randomized patients who had at least one dose of study drug.||Participants|||Number
792714|NCT00894387|Secondary|Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 6 Months|A cardiovascular event defined as CV death, heart faliure re-hospitalization, non-fatal myocardial infarction (MI), nonfatal stroke, sudden death with resuscitation.|6 months|Full analysis set included all randomized patients who had taken at least one dose of drug.||Participants|||Number
792715|NCT00894387|Secondary|Change From Baseline in the Clinical Summary Score to 1 Month, 6 Months and 12 Months|Symptom reduction and reduction in physical limitations was assessed using the clinical summary score of the Kansas City Cardiomyopathy Questionnaire (KCCQ). The KCCQ is a self-administered questionnaire and contains 23 items, covering physical function, clinical symptoms, social function, self-efficacy and knowledge, and Health-Related Quality of Life (QoL), including limitations, frequency, bother, change in condition, understanding, levels of enjoyment and satisfaction. Each scale score was calculated as the mean of its item scores and transformed to a 0–100 scale, with higher score indicating higher level of functioning. A score of 100 represents perfect health whereas a score of 0 represents death. A positive change in score from baseline indicates an improvement.|Baseline, 1 months, 6 months and 12 months|Full analysis set included all randomized patients who had taken at least one dose of drug. 'n' in each category indicates patients with assessable data both at baseline and corresponding time points.||units on a scale||Standard Error|Least Squares Mean
792716|NCT00894387|Secondary|Time to Event Analysis: Number of Patients Experienced the First Confirmed Occurrence of Either Cardiovascular Death or Heart Failure (HF) Re-hospitalization Within 12 Months|Time to first confirmed occurrence of either cardiovascular death or heart failure re-hospitalization within 12 months of randomization was the key secondary efficacy variable. For the primary efficacy analysis, an event will be considered for the analysis if it occurs on or before Day 395 (394 days from randomization). The secondary composite endpoint is the the composite of cardiovascular death or heart faliure re-hospitalization within 12 months.|12 months|Full analysis set (FAS) consisted of randomized patients who had received at least one dose of study drug.||Participants|||Number
792717|NCT00894465|Secondary|Anxiety Score From the State-Trait Anxiety Inventory|The State-Trait anxiety inventory is consists of 20 questions on a 4-point force-choice Likert-type response scales (scores 0 - 3). The 20 questions are summed together for final score. The score can range from 0 to 60 with higher scores representing higher levels of anxiety. This questionnaire was used to evaluate the anxiety level of the parents of the children who randomized to versed or placebo.|At the time of the procedure|||units on a scale||Standard Deviation|Mean
792718|NCT00894465|Primary|Anxiety Score From the Modified Yale Preoperative Anxiety Scale|The modified Yale preoperative scale consists of 5 categories (activity, vocalizations, emotional expressivity, state of apparent arousal, and use of parents). Four of the five categories are scored between 1-4 points and one of the categories is scored from 1-6 points. The scores are divided by their number of possible points in their respective category and multiplied by 20 to get the final anxiety score which ranges from 20 to 100. Low numbers represent low anxiety and higher numbers represent high anxiety.|Waiting room, before catheterization, and after catheterization|||units on a scale||Standard Deviation|Mean
792719|NCT00896233|Primary|Percent Difference in Maximum Liver Stiffness Between HCV- Positive Participants With Liver Fibrosis and Healthy Participants|"Reader evaluated 4 sections of the liver at 4 different time points and the end result was a single region of interest (ROI) that could be measured in the registered elastograms at each of the time points. Stiffness measures obtained using the Individual ROI (average of the 4 individual ROI's selected by the reader, one for each slice of liver) and Common ROI (intersection (or area of common overlap) of the 4 individual ROI's) analysis methods were compared."|14 days|Participants analyzed were Completers.||percent treatment difference||95% Confidence Interval|Number
792720|NCT00896233|Primary|Percent Difference in Mean Liver Stiffness Between Hepatitis C Virus (HCV)- Positive Participants With Liver Fibrosis and Healthy Participants|"Reader evaluated 4 sections of the liver at 4 different time points and the end result was a single region of interest (ROI) that could be measured in the registered elastograms at each of the time points. Stiffness measures obtained using the Individual ROI (average of the 4 individual ROI's selected by the reader, one for each slice of liver) and Common ROI (intersection (or area of common overlap) of the 4 individual ROI's) analysis methods were compared."|14 days|Participants analyzed were Completers.||percent treatment difference||95% Confidence Interval|Number
792721|NCT00896233|Primary|Repeated Mean Liver Elastic Stiffness (kPa) Measurements|"Reader evaluated 4 sections of the liver at 4 different time points and the end result was a single ROI that could be measured in the registered elastograms at each of the time points. Stiffness measures obtained using the Individual ROI (average of the 4 individual ROI's selected by the reader, one for each slice of liver) and Common ROI (intersection (or area of common overlap) of the 4 individual ROI's) analysis methods were compared. The mean was the overall mean of the data and the standard deviation was the within participant standard deviation."|14 days|Participants analyzed were Completers.||kPa||Standard Deviation|Mean
792722|NCT00896233|Primary|Repeated Maximum Liver Elastic Stiffness (Kilopascal [kPa]) Measurements|"Reader evaluated 4 sections of the liver at 4 different time points and the end result was a single region of interest (ROI) that could be measured in the registered elastograms at each of the time points. Stiffness measures obtained using the Individual ROI (average of the 4 individual ROI's selected by the reader, one for each slice of liver) and Common ROI (intersection (or area of common overlap) of the 4 individual ROI's) analysis methods were compared. The mean was the overall mean of the data and the standard deviation was the within participant standard deviation."|14 days|Participants analyzed were Completers.||kPa||Standard Deviation|Mean
792723|NCT00896337|Secondary|Walking Impairment Questionnaire Score - Stair Climbing|The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.|1 Year|Analysis was intention to treat; all participants in the study were to be evaluated to provide the information needed for this endpoint; 17 participants were not evaluable.||units on a scale||Standard Deviation|Mean
792724|NCT00896337|Secondary|Walking Impairment Questionnaire Score - Stair Climbing|The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.|9 Months|Analysis was intention to treat; all participants in the study were to be evaluated to provide the information needed for this endpoint; 15 participants were not evaluable.||units on a scale||Standard Deviation|Mean
792725|NCT00896337|Secondary|Walking Impairment Questionnaire Score-Stair Climbing|The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.|Pre-procedure/baseline|Analysis was intention to treat; all participants in the study were to be evaluated to provide the information needed for this endpoint; one participant was not evaluable.||units on a scale||Standard Deviation|Mean
792726|NCT00896337|Secondary|Walking Impairment Questionnaire Score - Speed|The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.|1 Year|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 16 participants were not evaluable.||units on a scale||Standard Deviation|Mean
792727|NCT00896337|Secondary|Walking Impairment Questionnaire Score - Speed|The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.|9 Months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 15 participants were not evaluable.||units on a scale||Standard Deviation|Mean
792728|NCT00896337|Secondary|Walking Impairment Questionnaire Score - Speed|The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.|Pre-procedure/baseline|Analysis was intention to treat; all participants in the study were to be evaluated to provide the information needed for this endpoint; one participant was not evaluable.||units on a scale||Standard Deviation|Mean
792729|NCT00896337|Secondary|Walking Impairment Questionnaire Score - Distance|The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.|1 Year|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 16 participants were not evaluable.||units on a scale||Standard Deviation|Mean
792730|NCT00896337|Secondary|Walking Impairment Questionnaire Score - Distance|The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.|9 Months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 15 participants were not evaluable.||units on a scale||Standard Deviation|Mean
792731|NCT00896337|Secondary|Walking Impairment Questionnaire Score - Distance|The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.|Pre-procedure/baseline|Analysis was intention to treat; all participants in the study were to be evaluated to provide the information needed for this endpoint; one participant was not evaluable.||units on a scale||Standard Deviation|Mean
792732|NCT00896337|Secondary|Restenosis Assessed by Duplex Ultrasound|Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Restenosis (defined per lesion)is defined as DUS SVR >2.5 or the presence of a target lesion revascularization prior to the DUS examination, regardless of the SVR value. In 1 subject, SVR was invalid and proximal peak systolic velocity by DUS was analyzed to assess restenosis.|1 Year|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 50 participants were not evaluable.||percentage of lesions|Participants||Number
792820|NCT00897390|Primary|Saxagliptin PK Parameter Time of Maximum Observed Plasma Concentration (Tmax)|Single-dose PK parameters of saxagliptin were derived from plasma concentration versus time data.|pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|Treated participants with PK measures||hours||Full Range|Median
792733|NCT00896337|Secondary|Restenosis Assessed by Duplex Ultrasound|Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Restenosis (defined per lesion)is defined as DUS SVR >2.5 or the presence of a target lesion revascularization prior to the DUS examination, regardless of the SVR value. In 1 subject, SVR was invalid and proximal peak systolic velocity by DUS was analyzed to assess restenosis.|9 Months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 30 participants were not evaluable.||percentage of lesions|Participants||Number
792734|NCT00896337|Secondary|Secondary Patency|Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Secondary patency (defined per lesion) is defined as having DUS SVR ≤2.5 in the absence of bypass of the target lesion or amputation. In 1 subject, SVR was invalid and proximal peak systolic velocity was analyzed to assess restenosis.|1 Year|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 50 participants were not evaluable||percentage of lesions|Participants||Number
792735|NCT00896337|Secondary|Secondary Patency|Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Secondary patency (defined per lesion) is defined as having DUS SVR ≤2.5 in the absence of bypass of the target lesion or amputation. In 1 subject, SVR was invalid and proximal peak systolic velocity was analyzed to assess restenosis.|9 Months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 31 participants were not evaluable||percentage of lesions|Participants||Number
792736|NCT00896337|Secondary|Primary-assisted Patency (PAP)|Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Primary-assisted patency (defined per lesion) is defined as DUS SVR ≤2.5 with no target lesion revascularization for total occlusion, bypass of the target lesion, or amputation. In 1 subject, SVR was invalid and DUS proximal peak systolic velocity was analyzed to assess restenosis.|1 Year|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 50 participants were not evaluable.||percentage of lesions|Participants||Number
792737|NCT00896337|Secondary|Primary-assisted Patency (PAP)|Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Primary-assisted patency (defined per lesion) is defined as DUS SVR ≤2.5 with no target lesion revascularization for total occlusion, bypass of the target lesion, or amputation. In 1 subject, SVR was invalid and DUS proximal peak systolic velocity was analyzed to assess restenosis.|9 Months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 30 participants were not evaluable.||percentage of lesions|Participants||Number
792738|NCT00896337|Secondary|Primary Patency|Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Primary patency (defined per lesion) is defined as DUS SVR ≤2.5 with no target lesion revascularization, bypass of the target lesion, or amputation.|1 Year|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 50 participants were not evaluable||percentage of lesions|Participants||Number
792739|NCT00896337|Secondary|Primary Patency|Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Primary patency (defined per lesion) is defined as DUS SVR ≤2.5 with no target lesion revascularization, bypass of the target lesion, or amputation.|9 Months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 30 participants were not evaluable||percentage of lesions|Participants||Number
792740|NCT00896337|Secondary|Ankle-Brachial Index (ABI)|"Ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm as follows:
Ankle: The systolic pressure will be measured in the index limb at the arteria dorsalis pedis and/or the arteria tibialis posterior. If both pressures are measured, the highest pressures will be used for the ABI calculation.
Brachial: The systolic pressure will be measured in both arms, and the highest of both pressures will be used for the ABI calculation."|1 Year|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 16 participants were not evaluable.||ratio|Participants|Standard Deviation|Mean
792741|NCT00896337|Secondary|Ankle-Brachial Index (ABI)|"Ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm as follows:
Ankle: The systolic pressure will be measured in the index limb at the arteria dorsalis pedis and/or the arteria tibialis posterior. If both pressures are measured, the highest pressures will be used for the ABI calculation.
Brachial: The systolic pressure will be measured in both arms, and the highest of both pressures will be used for the ABI calculation."|9 Months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 15 participants were not evaluable.||ratio|Participants|Standard Deviation|Mean
792742|NCT00896337|Secondary|Ankle-Brachial Index (ABI)|"Ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm as follows:
Ankle: The systolic pressure will be measured in the index limb at the arteria dorsalis pedis and/or the arteria tibialis posterior. If both pressures are measured, the highest pressures will be used for the ABI calculation.
Brachial: The systolic pressure will be measured in both arms, and the highest of both pressures will be used for the ABI calculation."|30 Days|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 4 participants were not evaluable.||ratio|Participants|Standard Deviation|Mean
792767|NCT00896337|Secondary|Early Clinical Success|"Improvement in Rutherford classification by 1 class as compared to baseline. Rutherford Classification is used to assess lower extremity ischemia as shown below:
Class 0 = Asymptomatic Class 1 = Mild claudication Class 2 = Moderate claudication Class 3 = Severe claudication Class 4 = Ischemic rest pain Class 5 = Minor tissue loss – non-healing ulcer, focal gangrene with diffuse pedal edema"|30 Days|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 12 participants were not evaluable||percentage of participants|||Number
792743|NCT00896337|Secondary|Ankle-Brachial Index|"Ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm as follows:
Ankle: The systolic pressure will be measured in the index limb at the arteria dorsalis pedis and/or the arteria tibialis posterior. If both pressures are measured, the highest pressures will be used for the ABI calculation.
Brachial: The systolic pressure will be measured in both arms, and the highest of both pressures will be used for the ABI calculation."|Hospital Discharge (1-2 days post-procedure)|Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint||ratio|Participants|Standard Deviation|Mean
792744|NCT00896337|Secondary|Ankle-Brachial Index (ABI)|"Ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm as follows:
Ankle: The systolic pressure will be measured in the index limb at the arteria dorsalis pedis and/or the arteria tibialis posterior. If both pressures are measured, the highest pressures will be used for the ABI calculation.
Brachial: The systolic pressure will be measured in both arms, and the highest of both pressures will be used for the ABI calculation."|Pre-procedure/baseline|Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint||ratio|Participants|Standard Deviation|Mean
792745|NCT00896337|Secondary|Target Lesion Revascularization (TLR)|Target lesion revascularization (TLR) is any surgical or percutaneous intervention to the target lesion(s) after the index procedure. A TLR will be considered ischemia-driven if the target lesion diameter stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms. A TLR will be considered ischemia-driven if the lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia.|3 Years|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 24 participants were not evaluable.||percentage of lesions|Participants||Number
792746|NCT00896337|Secondary|Target Lesion Revascularization (TLR)|Target lesion revascularization (TLR) is any surgical or percutaneous intervention to the target lesion(s) after the index procedure. A TLR will be considered ischemia-driven if the target lesion diameter stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms. A TLR will be considered ischemia-driven if the lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia.|2 Years|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 19 participants were not evaluable.||percentage of lesions|Participants||Number
792747|NCT00896337|Secondary|Target Lesion Revascularization (TLR)|Target lesion revascularization (TLR) is any surgical or percutaneous intervention to the target lesion(s) after the index procedure. A TLR will be considered ischemia-driven if the target lesion diameter stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms. A TLR will be considered ischemia-driven if the lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia.|1 Year|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 13 participants were not evaluable.||percentage of lesions|Participants||Number
792748|NCT00896337|Secondary|Target Lesion Revascularization (TLR)|Target lesion revascularization (TLR) is any surgical or percutaneous intervention to the target lesion(s) after the index procedure. A TLR will be considered ischemia-driven if the target lesion diameter stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms. A TLR will be considered ischemia-driven if the lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia.|9 Months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 7 participants were not evaluable.||percentage of lesions|Participants||Number
792749|NCT00896337|Secondary|Target Lesion Revascularization (TLR)|Target lesion revascularization (TLR) is any surgical or percutaneous intervention to the target lesion(s) after the index procedure. A TLR will be considered ischemia-driven if the target lesion diameter stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms. A TLR will be considered ischemia-driven if the lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia.|30 Days|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 4 participants were not evaluable.||percentage of lesions|Participants||Number
792750|NCT00896337|Secondary|Stent Thrombosis|"Angiographic documentation of an acute, complete occlusion of a previously successfully treated lesion and/or Angiographic documentation of a flow-limiting thrombus within, or adjacent to, a previously successfully treated lesion
Very late stent thrombosis is defined as >365 days following the trial procedure."|3 Years|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 24 participants were not evaluable||percentage of participants|||Number
792751|NCT00896337|Secondary|Stent Thrombosis|"Angiographic documentation of an acute, complete occlusion of a previously successfully treated lesion and/or Angiographic documentation of a flow-limiting thrombus within, or adjacent to, a previously successfully treated lesion
Very late stent thrombosis is defined as >365 days following the trial procedure."|2 Years|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 19 participants were not evaluable||percentage of participants|||Number
792752|NCT00896337|Secondary|Stent Thrombosis|"Angiographic documentation of an acute, complete occlusion of a previously successfully treated lesion and/or Angiographic documentation of a flow-limiting thrombus within, or adjacent to, a previously successfully treated lesion
Late stent thrombosis is defined as >30 days to 365 days following the trial procedure."|1 Year|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 13 participants were not evaluable||percentage of participants|||Number
792753|NCT00896337|Secondary|Stent Thrombosis|"Angiographic documentation of an acute, complete occlusion of a previously successfully treated lesion and/or Angiographic documentation of a flow-limiting thrombus within, or adjacent to, a previously successfully treated lesion
Late stent thrombosis is defined as >30 days to 365 days following the trial procedure."|9 Months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 7 participants were not evaluable||percentage of participants|||Number
792754|NCT00896337|Secondary|Sub-acute Stent Thrombosis|"Angiographic documentation of an acute, complete occlusion of a previously successfully treated lesion and/or Angiographic documentation of a flow-limiting thrombus within, or adjacent to, a previously successfully treated lesion
Acute stent thrombosis is defined as occurring less than or equal to 24 hours following the trial procedure. Subacute stent thrombosis is defined as occurring >24 hours to less than or equal to 30 days following the trial procedure."|>24 Hours to <=30 Days Post-index procedure|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 4 participants were not evaluable||percentage of participants|||Number
792755|NCT00896337|Secondary|Acute Stent Thrombosis|"Angiographic documentation of an acute, complete occlusion of a previously successfully treated lesion and/or Angiographic documentation of a flow-limiting thrombus within, or adjacent to, a previously successfully treated lesion
Acute stent thrombosis is defined as occurring <=24 hours following the trial procedure. Subacute stent thrombosis is defined as occurring >24 hours to <=30 days following the trial procedure."|24 Hours|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 4 participants were not evaluable.||percentage of participants|||Number
792756|NCT00896337|Secondary|Rutherford Classification Distribution|"Rutherford Classification is used to assess lower extremity ischemia as shown below:
Class 0 = Asymptomatic Class 1 = Mild claudication Class 2 = Moderate claudication Class 3 = Severe claudication Class 4 = Ischemic rest pain Class 5 = Minor tissue loss – non-healing ulcer, focal gangrene with diffuse pedal edema Class 6 = Major tissue loss"|1 Year|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; there were 19 participants not evaluable.||percentage of participants|||Number
792757|NCT00896337|Secondary|Rutherford Classification Distribution|"Rutherford Classification is used to assess lower extremity ischemia as shown below:
Class 0 = Asymptomatic Class 1 = Mild claudication Class 2 = Moderate claudication Class 3 = Severe claudication Class 4 = Ischemic rest pain Class 5 = Minor tissue loss – non-healing ulcer, focal gangrene with diffuse pedal edema Class 6 = Major tissue loss"|9 Months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; there were 16 participants not evaluable.||percentage of participants|||Number
792758|NCT00896337|Secondary|Rutherford Classification Distribution|"Rutherford Classification is used to assess lower extremity ischemia as shown below:
0 = Asymptomatic
= Mild claudication
= Moderate claudication
= Severe claudication
= Ischemic rest pain
= Minor tissue loss – non-healing ulcer, focal gangrene with diffuse pedal edema"|30 Days|Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint; 12 participants were not evaluable.||percentage of participants|||Number
792759|NCT00896337|Secondary|Rutherford Classification Distribution|"Rutherford Classification is used to assess lower extremity ischemia as shown below:
0 = Asymptomatic
= Mild claudication
= Moderate claudication
= Severe claudication
= Ischemic rest pain
= Minor tissue loss – non-healing ulcer, focal gangrene with diffuse pedal edema"|Post-procedure|Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint; 12 participants were not evaluable.||percentage of participants|||Number
792760|NCT00896337|Secondary|Rutherford Classification Distribution|"Rutherford Classification is used to assess lower extremity ischemia as shown below:
0 = Asymptomatic
= Mild claudication
= Moderate claudication
= Severe claudication
= Ischemic rest pain
= Minor tissue loss – non-healing ulcer, focal gangrene with diffuse pedal edema"|Pre-procedure/baseline|Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint||percentage of participants|||Number
792761|NCT00896337|Secondary|Late Hemodynamic Success|Improvement in ankle-brachial index (ABI) by ≥0.1 from the pre-procedure value and not deteriorated by >0.15 from the maximum post-procedure value. Reported per limb.|1 Year|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 11 participants were not evaluable.||percentage of limbs|Participants||Number
792762|NCT00896337|Secondary|Late Hemodynamic Success|Improvement in ankle-brachial index (ABI) by ≥0.1 from the pre-procedure value and not deteriorated by >0.15 from the maximum post-procedure value. Reported per limb.|9 Months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 8 participants were not evaluable.||percentage of limbs|Participants||Number
792763|NCT00896337|Secondary|Early Hemodynamic Success|Improvement in ankle-brachial index (ABI) by ≥0.1 from the pre-procedure value and not deteriorated by >0.15 from the maximum post-procedure value. Reported per limb.|30 Days|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 12 participants were not evaluable.||percentage of limbs|Participants||Number
792764|NCT00896337|Secondary|Early Hemodynamic Success|Improvement in ankle-brachial index (ABI) by ≥0.1 from the pre-procedure value and not deteriorated by >0.15 from the maximum post-procedure value. Reported per limb.|Hospital Discharge|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 12 participants were not evaluable.||percentage of limbs|Participants||Number
792765|NCT00896337|Secondary|Late Clinical Success|"Improvement in Rutherford classification by 1 class as compared to baseline. Rutherford Classification is used to assess lower extremity ischemia as shown below:
Class 0 = Asymptomatic Class 1 = Mild claudication Class 2 = Moderate claudication Class 3 = Severe claudication Class 4 = Ischemic rest pain Class 5 = Minor tissue loss – non-healing ulcer, focal gangrene with diffuse pedal edema"|1 Year|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint. There were 19 participants not evaluable.||percentage of patients|||Number
792766|NCT00896337|Secondary|Late Clinical Success|"Improvement in Rutherford classification by 1 class as compared to baseline. Rutherford Classification is used to assess lower extremity ischemia as shown below:
Class 0 = Asymptomatic Class 1 = Mild claudication Class 2 = Moderate claudication Class 3 = Severe claudication Class 4 = Ischemic rest pain Class 5 = Minor tissue loss – non-healing ulcer, focal gangrene with diffuse pedal edema"|9 Months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint. There were 16 participants not evaluable.||percentage of patients|||Number
792768|NCT00896337|Secondary|Early Clinical Success|"Improvement in Rutherford classification by 1 class as compared to baseline. Rutherford Classification is used to assess lower extremity ischemia as shown below:
Class 0 = Asymptomatic Class 1 = Mild claudication Class 2 = Moderate claudication Class 3 = Severe claudication Class 4 = Ischemic rest pain Class 5 = Minor tissue loss – non-healing ulcer, focal gangrene with diffuse pedal edema"|Hospital Discharge|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 12 participants were not evaluable||percentage of participants|||Number
792769|NCT00896337|Secondary|Procedure Success|Technical success (residual lesion stenosis <=30% based on visual assessment immediately postprocedure) and no in-hospital major adverse events (device- or index procedure-related death, myocardial infarction, target vessel revascularization or amputation of the index limb).|In hospital (1-2 days post procedure)|Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint||percentage of participants|||Number
792770|NCT00896337|Secondary|Technical Success|Residual lesion stenosis <=30% based on visual assessment immediately postprocedure|Index procedure|Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint||percentage of lesions|Participants||Number
792771|NCT00896337|Secondary|Myocardial Infarction (MI)|Definition of myocardial infarction: New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase- myoglobin band (CK-MB)/troponin above upper limit of normal (ULN); if no new Q-waves elevation of post-procedure CK levels >2.0× ULN with positive CK-MB, or, if the assay for CK-MB was not performed, elevation of CK levels >2.0× ULN with positive troponin. Drawing a CK-MB or troponin is mandated if CK is greater than 2× ULN. If no CK-MB or troponin was drawn, CK >2× ULN will be considered an MI. ULN is determined per local laboratory specifications.|Index hospitalization|Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint||percentage of participants|||Number
792772|NCT00896337|Secondary|Target Vessel Revascularization (TVR)|"Target vessel revascularization (TVR) is defined as any surgical or percutaneous intervention to the target vessel(s) after the index procedure. A TVR is considered ischemia-driven if the culprit lesion stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms.
A TVR is considered ischemia-driven if the culprit lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia."|3 Years|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 24 participants were not evaluable.||percentage of participants|||Number
792773|NCT00896337|Secondary|Target Vessel Revascularization (TVR)|"Target vessel revascularization (TVR) is defined as any surgical or percutaneous intervention to the target vessel(s) after the index procedure. A TVR is considered ischemia-driven if the culprit lesion stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms.
A TVR is considered ischemia-driven if the culprit lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia."|2 Years|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 19 participants were not evaluable.||percentage of participants|||Number
792774|NCT00896337|Secondary|Target Vessel Revascularization (TVR)|"Target vessel revascularization (TVR) is defined as any surgical or percutaneous intervention to the target vessel(s) after the index procedure. A TVR is considered ischemia-driven if the culprit lesion stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms.
A TVR is considered ischemia-driven if the culprit lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia."|1 Year|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 13 participants were not evaluable.||percentage of participants|||Number
792775|NCT00896337|Secondary|Target Vessel Revascularization (TVR)|"Target vessel revascularization (TVR) is defined as any surgical or percutaneous intervention to the target vessel(s) after the index procedure. A TVR is considered ischemia-driven if the culprit lesion stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms.
A TVR is considered ischemia-driven if the culprit lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia."|9 Months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 7 participants were not evaluable.||percentage of participants|||Number
792776|NCT00896337|Secondary|Target Vessel Revascularization (TVR)|"Target vessel revascularization (TVR) is defined as any surgical or percutaneous intervention to the target vessel(s) after the index procedure. A TVR is considered ischemia-driven if the culprit lesion stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms.
A TVR is considered ischemia-driven if the culprit lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia."|30 Days|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 4 participants were not evaluable.||percentage of participants|||Number
792777|NCT00896337|Secondary|Amputation of Index Limb|Major amputation: amputation of the lower limb at the ankle level or above Minor amputation: amputation of forefoot or toes|3 Years|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 25 participants were not evaluable.||percentage of participants|||Number
792778|NCT00896337|Secondary|Amputation of Index Limb|Major amputation: amputation of the lower limb at the ankle level or above Minor amputation: amputation of forefoot or toes|2 Years|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 19 participants were not evaluable.||percentage of participants|||Number
792779|NCT00896337|Secondary|Amputation of Index Limb|Major amputation: amputation of the lower limb at the ankle level or above Minor amputation: amputation of forefoot or toes|1 Year|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 13 participants were not evaluable.||percentage of participants|||Number
792780|NCT00896337|Secondary|Amputation of Index Limb|Major amputation: amputation of the lower limb at the ankle level or above Minor amputation: amputation of forefoot or toes|9 Months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 7 participants were not evaluable.||percentage of participants|||Number
792781|NCT00896337|Secondary|Death|Death is classified as follows. Cardiac death: death due to immediate cardiac cause; death of unknown cause is classified as cardiac death, including all procedure related deaths including those related to concomitant treatment; Vascular death: death due to cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause; Non-cardiovascular death: any death not covered by the above definitions|3 Years|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 18 participants were not evaluable.||percentage of participants|||Number
792782|NCT00896337|Secondary|Death|Death is classified as follows. Cardiac death: death due to immediate cardiac cause; death of unknown cause is classified as cardiac death, including all procedure related deaths including those related to concomitant treatment; Vascular death: death due to cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause; Non-cardiovascular death: any death not covered by the above definitions|2 Years|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 17 participants were not evaluable.||percentage of participants|||Number
792783|NCT00896337|Secondary|Death|Death is classified as follows. Cardiac death: death due to immediate cardiac cause; death of unknown cause is classified as cardiac death, including all procedure related deaths including those related to concomitant treatment; Vascular death: death due to cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause; Non-cardiovascular death: any death not covered by the above definitions|1 Year|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 11 participants were not evaluable.||percentage of participants|||Number
792784|NCT00896337|Secondary|Death|Death is classified as follows. Cardiac death: death due to immediate cardiac cause; death of unknown cause is classified as cardiac death, including all procedure related deaths including those related to concomitant treatment; Vascular death: death due to cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause; Non-cardiovascular death: any death not covered by the above definitions|9 Months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 7 participants were not evaluable.||percentage of participants|||Number
792785|NCT00896337|Secondary|Death|Death is classified as follows. Cardiac death: death due to immediate cardiac cause, death of unknown cause is classified as cardiac death, including all procedure related deaths including those related to concomitant treatment; Vascular death: death due to cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause; Non-cardiovascular death: any death not covered by the above definitions|30 Days|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 4 participants were not evaluable.||percentage of participants|||Number
792786|NCT00896337|Primary|Device- and/or Procedure-related Major Adverse Events (MAE)|MAE is defined as any device-related or index procedure-related death within 30 days, myocardial infarction during index hospitalization, target vessel revascularization through 9 months, or amputation of the index limb through 9 months|9 Months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 7 participants were not evaluable.||percentage of participants|||Number
792787|NCT00896454|Secondary|Change From Baseline in Corrected Serum Calcium||Baseline and Days 2, 4, 8, 10, 15, 19, 23, 29, 36, 43, 50 and 57|Efficacy Analysis Subset included all participants who received at least 1 dose of denosumab. n = Number of participants who had non-missing data at Baseline and the time point of interest.||mmol/L||Inter-Quartile Range|Median
792788|NCT00896454|Secondary|Time to Relapse/Nonresponse of Hypercalcemia of Malignancy|Time to relapse/nonresponse was defined as the number of days from study Day 1 until the last day of CSC ≤ 11.5 mg/dL for all particiipants with relapse after the first response. Participants were censored on the last CSC assessment day if their CSC level never reached > 11.5 mg/dL after first response. For participants who never achieved response, time to relapse/nonresponse was set to zero. Otherwise, if there was no post-baseline CSC assessment, time to relapse/nonresponse was censored on study Day 1. Time to relapse/nonresponse was estimated using the Kaplan-Meier method.|From Day 1 until the end of study date or primary data cutoff date (13 September 2012), whichever occured first; median time on study was 1.8 months.|Response Analysis Subset||days||95% Confidence Interval|Median
792789|NCT00896454|Secondary|Duration of Complete Response|Duration of complete response is defined as the number of days from the first day of of corrected serum calcium ≤ 10.8 mg/dL (2.7 millimoles/L) to the last day of corrected serum calcium ≤ 10.8 mg/dL. Participants were censored on the last CSC assessment day if their CSC level never reached > 10.8 mg/dL after the complete response. If a participant had no CSC assessment after the complete response, duration of complete response was set to zero and censored. Duration of complete response was summarized for participants who achieved a complete response using the Kaplan-Meier method.|From Day 1 until the end of study date or primary data cutoff date (13 September 2012), whichever occured first; median time on study was 1.8 months.|Participants with a complete response in the Response Analysis Subset||days||95% Confidence Interval|Median
792790|NCT00896454|Secondary|Duration of Response|Duration of response is defined as the number of days from the first day of corrected serum calcium ≤ 11.5 mg/dL (2.9 millimoles/L) to the last day of corrected serum calcium ≤ 11.5 mg/dL. Participants were censored on the last CSC assessment day if their CSC level never reached > 11.5 mg/dL after the first response. If a participant had no CSC assessment after the first response, duration of response was set to zero and censored. Duration of response was summarized for participants who achieved a response using the Kaplan-Meier method.|From Day 1 until the end of study date or primary data cutoff date (13 September 2012), whichever occured first; median time on study was 1.8 months.|Participants with a response in the Response Analysis Subset||days||95% Confidence Interval|Median
792804|NCT00897104|Primary|Time to Relief Within 2 Hours After Treatment|Participants reporting time to relief (defined as the first time that a participant reported grade 0 or 1 in headache severity within 2 hours after treatment (for the comparison of rizatriptan 5 mg and sumatriptan 50 mg).|within 2 hours after treatment|An “all-participants-treated” approach was used in the primary analysis, including all participants who had at least one assessment of pain severity within 2 hours after test medication.||Participants|||Number
792791|NCT00896454|Secondary|Time to Complete Response|Time to complete response was defined as the time period from study Day 1 to the first time post-baseline corrected serum calcium (CSC) was ≤ 10.8 mg/dL (2.7 mmol/L). Participants were censored on the last CSC assessment day if no complete response was observed. If there was no post-baseline CSC assessment, time to complete response was censored on study Day 1. Time to complete response was analyzed using Kaplan–Meier methods.|From Day 1 until the end of study date or primary data cutoff date (13 September 2012), whichever occured first; median time on study was 1.8 months.|Response Analysis Subset||days||95% Confidence Interval|Median
792792|NCT00896454|Secondary|Time to Response|"Time to Response was defined as the time period from study Day 1 to the first time post-baseline corrected serum calcium (CSC) ≤ 11.5 mg/dL. Participants were censored on the last CSC assessment day if no response was observed. If there was no post-baseline CSC assessment, time to response was censored on study Day 1.
Time to response was analyzed using Kaplan–Meier methods."|From Day 1 until the end of study date or primary data cutoff date (13 September 2012), whichever occured first; median time on study was 1.8 months.|Response Analysis Subset||days||95% Confidence Interval|Median
792793|NCT00896454|Secondary|Percentage of Participants With a Complete Response by Visit|Response is defined as corrected serum calcium (CSC) ≤ 10.8 mg/dL (2.7 mmol/L). For all CSC values, if albumin was < 4 g/dL, the following formula was used to calculate CSC: CSC = Total serum calcium [mg/dL] + (0.8 x (4 – serum albumin [g/dL])).|Days 2, 4, 8, 10, 15, 19, 23, 29, 36, 43, 50 and 57|Response Analysis Subset||percentage of participants||95% Confidence Interval|Number
792794|NCT00896454|Secondary|Percentage of Participants With a Response by Visit|Response is defined as corrected serum calcium (CSC) ≤ 11.5 mg/dL, within 10 days after the first dose of denosumab. For all CSC values, if albumin was < 4 g/dL, the following formula was used to calculate CSC: CSC = Total serum calcium [mg/dL] + (0.8 x (4 – serum albumin [g/dL]))|Days 2, 4, 8, 10, 15, 19, 23, 29, 36, 43, 50 and 57|Response Analysis Subset||percentage of participants||95% Confidence Interval|Number
792795|NCT00896454|Primary|Percentage of Participants With a Response Within 10 Days of First Dose of Denosumab|Response is defined as corrected serum calcium (CSC) ≤ 11.5 mg/dL, within 10 days after the first dose of denosumab. For all CSC values, if albumin was < 4 g/dL, the following formula was used to calculate CSC: CSC = Total serum calcium [mg/dL] + (0.8 x (4 – serum albumin [g/dL]))|10 days|Response Analysis Subset including all participants who received at least 1 dose of denosumab and had a screening CSC (from local lab) > 12.5 mg/dL (3.1 mmol/L).||percentage of participants||95% Confidence Interval|Number
792796|NCT00896649|Secondary|Patient Satisfaction Level as Pertaining to Comfort and Pain for Each Study|Number of participants satisfied with positron emission mammography with regard to comfort and pain for each study 1-7 rating scale, Entries from 1-4 considered Satisfied. Entries 5-7 considered not Satisfied.|One month|All participants who completed imaging and questionnaires.||participants|||Number
792797|NCT00896649|Primary|"Frequency of Breast Imaging Assessment Reporting and Data System (BI-RADS) 0 Call-back in Mammography vs Breast Imaging Assessment Reporting and Data System (BI-RADS) 0 in Positron Emission Mammography"|"Number of participants called back due to Breast Imaging Assessment Reporting and Data System (BI-RADS) 0 Mammogram compared to number of patients with Breast Imaging Assessment Reporting and Data System (BI-RADS) 0 in positron emission mammography
Breast Imaging Assessment Reporting and Data System (BI-RADS) Scale:
0 = Inconclusive for malignancy; call-back in mammography
= normal
= abnormal, with no malignancy
= abnormal, likely benign
= abnormal, likely malignant
= malignant"|immediately at completion of mammogram|Number of participants who completed protocol with complete data set||participants|||Number
792798|NCT00896779|Primary|Mean Change in Visual Acuity|Change in vision from baseline measurement at 12 months. Standard ETDRS chart (80 letters) was used to determine visual acuity with test luminance of 45 cd/m ^2 at 8 feet. Number of correctly read letters were reported.|12 months|||letters||Standard Deviation|Mean
792799|NCT00897104|Secondary|Duration of Relief (Time to Recurrence From the Time of First Recorded Pain Relief [Grade = 0 or 1])|Duration of relief or the time to recurrence from the time of first recorded pain relief (grade = 0 or 1) was calculated for responders who had a headache recurrence|24 hours|The duration of relief, or the time to recurrence from the time of first recorded pain relief (grade = 0 or 1), was calculated for responders who had a headache recurrence.||Hours||Standard Deviation|Mean
792800|NCT00897104|Secondary|Participants Who Used Escape Medication 2 Hours After the Treatment Dose|Escape medication is defined as rescue medication for participants who experienced lack of efficacy from the study medication.|2 hours after treatment|An “all-participants-treated” approach was used in the secondary analysis. Missing data were replaced by carrying forward the preceding value.||Participants|||Number
792801|NCT00897104|Secondary|Presence or Absence of Associated Symptoms (Photophobia, Phonophobia, Nausea, and Vomiting) at 2 Hours After Treatment|Participants who recorded the presence or absence of the associated symptoms photophobia, phonophobia, nausea, and vomiting at 2 hours after treatment.|2 hours after treatment|“All-participants-treated” approach was used. Missing data were replaced by carrying forward the preceding value. Participants Analyzed For Nausea: Rizatriptan 348; Sumatriptan 352; Placebo 78. Participants Analyzed for Vomiting: Rizatriptan 342; Sumatriptan 342; Placebo 73. Number of participants analyzed is correct for the other categories.||Participants|||Number
792802|NCT00897104|Secondary|Lack of Functional Disability at 2 Hours After Treatment as Measured by the Level of Impairment in Daily Activities|Participants with no functional disability measured by the level of impairment to daily activities at 2 hours after treatment. Each participant rated functional disability on a 4-grade scale (0 =normal; 1 = daily activities mildly impaired; 2 = daily activities severely impaired; 3 =unable to carry out daily activities, required bed rest).|2 hours after treatment|An “all-participants-treated” approach was used in the secondary analysis. Missing data were replaced by carrying forward the preceding value.||Participants|||Number
792803|NCT00897104|Secondary|Pain Free at 2 Hours After Treatment|Participants pain free (defined as a reduction of headache severity to grade 0 [no pain]) at 2 hours after treatment. Each participant rated headache severity on a 4-grade scale (0 = no headache; 1 = mild pain; 2 = moderate pain; 3 = severe pain).|2 hours after treatment|An “all-participants-treated” approach was used in the secondary analysis, including all participants who had at least one assessment of pain severity within 2 hours after test medication. Missing data were replaced by carrying forward the preceding value.||Participants|||Number
792805|NCT00897104|Primary|Pain Relief at 2 Hours After Treatment|Participants reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe pain) at baseline to grades 0 or 1 (no headache or mild pain) at 2 hours after treatment|2 hours after treatment|An “all-participants-treated” approach was used in the primary analysis, including all participants who had at least one assessment of pain severity within 2 hours after dose. Missing data were replaced by carrying forward the preceding value.||Participants|||Number
792806|NCT00897390|Secondary|Electrocardiogram (ECG), Vital Sign, and Physical Finding Abnormalities|12-lead Electrocardiogram (ECG), Vital Sign (body temperature, respiratory rate, seated blood pressure and heart rate), and Physical Finding Abnormalities reported by investigator as AEs.|At Screening (within 21 days of Study Day 1), Day -1 of Period 1 (ECG and Physical only), Day 1 of Periods 1-4 (Vitals only), at Study Discharge (Day 3 of Period 4) or Discontinuation|Treated participants. One participant each in Arm C and Arm D was not evaluated for this measure.||participants|||Number
792807|NCT00897390|Secondary|Number of Participants With Marked Urinalysis Abnormalities|Protein, Urine Abnormality: if value >= 2+ (or if pretreatment value >= 1+, then >= 2 * pretreatment). Glucose, Urine Abnormality: if value >= 2+ (or if pretreatment value >= 1+, then >= 2 * pretreatment). Blood, Urine Abnormality: if value >= 2+ (or if pretreatment value >= 1+, then >= 2 * pretreatment). White Blood Cell (WBC), Urine Abnormality: if value >= 2+ (or if pretreatment value >= 2+, then >= 4+). Red Blood Cell (RBC), Urine Abnormality: if value >= 2+ (or if pretreatment value >= 2+, then >= 4+). (The '+' is a normal lab result and refers to the magnitude of the finding.)|Within 21 days of study Day 1, Days 1-3 of Periods 1, 2, 3, and 4.|Number of Participants Analyzed=treated participants; n=number of participants evaluated for this measure (among the 6 participants who had the urinary WBC and RBC test, there are only 2 had a pre-study evaluation, and were therefore evaluable for these measures.||participants|||Number
792808|NCT00897390|Secondary|Number of Participants With Marked Laboratory Abnormalities (MA)|Laboratory abnormalities=any result that is clinically significant, met the definition of an SAE, required discontinuation or interruption of study drug, or required specific corrective therapy. Upper normal (UN)/lower normal (LN) values: leukocytes UN, 11.40x10^3 c/uL; absolute neutrophils/bands LN, 1.500x10^3 c/uL; aspartate aminotransferase UN, 48 U/L; alanine aminotransferase UN, 67 U/L; blood urea nitrogen UN, 20.0 mg/dL; creatine kinase UN, 350 U/L; lactate dehydrogenase UN, 249 U/L.|Within 21 days of study Day 1, Days 1-3 of Periods 1, 2, 3, and 4.|Treated participants. One participant each in Arm C and Arm D was not evaluated for this measure.||participants|||Number
792809|NCT00897390|Secondary|AEs of Special Interest|See Outcome Measure 16 for a definition of AEs. AEs of clinical interest for saxagliptin were defined as those relating to the following:skin disorders, infection-related AEs (system organ class [SOC]: Infections and Infestations), thrombocytopenia, lymphopenia, hypoglycemia, cardiovascular AEs indicative of acute cardiovascular events, localized edema, fractures, pancreatitis, and AEs of hypersensitivity.|AEs collected from Day 1/Period 1 through study discharge (study duration: approximately 45 days).|All treated participants||participants|||Number
792810|NCT00897390|Secondary|Deaths, Serious Adverse Events (SAEs), Adverse Events (AEs), and Discontinuations Due to AEs|An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a patient or clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.|AEs collected from Day 1/Period 1 through study discharge (study duration: approximately 45 days). SAEs collected from date of written consent until 30 days post discontinuation of dosing or subject’s participation in the study.|All treated participants||participants|||Number
792811|NCT00897390|Secondary|BMS-510849 PK Parameter T-Max|Single-dose PK parameters of the active metabolite of saxagliptin, BMS-510849, were derived from plasma concentration versus time data.|pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|Treated participants with PK measures||hours||Full Range|Median
792812|NCT00897390|Secondary|BMS-510849 PK Parameter T-Half|Single-dose PK parameters of the active metabolite of saxagliptin, BMS-510849, were derived from their respective plasma concentration versus time data.|pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|Treated participants with PK measures||hours||Standard Deviation|Mean
792813|NCT00897390|Secondary|BMS-510849 PK Parameter Cmax|Single-dose PK parameters of the active metabolite of saxagliptin, BMS-510849, were derived from plasma concentration versus time data.|pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|Treated participants with PK measures||ng/mL||Full Range|Geometric Mean
792814|NCT00897390|Secondary|BMS-510849 PK Parameter AUC(0-T)|Single-dose PK parameters of the active metabolite of saxagliptin, BMS-510849, were derived from plasma concentration versus time data.|pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|Treated participants with PK measures||ng*h/mL||Full Range|Geometric Mean
792815|NCT00897390|Primary|Metformin PK Parameter Tmax|Single-dose PK parameters of metformin were derived from plasma concentration versus time data.|pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|Treated participants with PK measures||hours||Full Range|Median
792816|NCT00897390|Primary|Metformin PK Parameter T-HALF|Single-dose PK parameters of metformin were derived from plasma concentration versus time data.|pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|Treated participants with PK measures||hours||Standard Deviation|Mean
792817|NCT00897390|Primary|Metformin PK Parameter Cmax|Single-dose PK parameters of metformin were derived from plasma concentration versus time data.|pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|Treated participants with PK measures||ng/mL||Full Range|Geometric Mean
792818|NCT00897390|Primary|Metformin PK Parameter AUC(0-T)|Single-dose PK parameters of metformin were derived from plasma concentration versus time data.|pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|Treated participants with PK measures||ng*h/mL||Full Range|Geometric Mean
792906|NCT00899717|Secondary|Maximum Mouth Opening (mm)|Maximum voluntary unassisted mouth opening|6 months (before and after therapy) including 4 assessment points: pre-treatment, post-treatment, 3- and 6-month follow up|||mm||Standard Deviation|Mean
792821|NCT00897390|Primary|Saxagliptin PK Parameter Plasma Terminal Half-life (T-HALF)|Single-dose PK parameters of saxagliptin were derived from plasma concentration versus time data.|pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|Treated participants with PK measures||hours||Standard Deviation|Mean
792822|NCT00897390|Primary|Saxagliptin PK Parameter Maximum Observed Plasma Concentration (Cmax)|Single-dose PK parameters of saxagliptin were derived from plasma concentration versus time data.|pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|Treated participants with PK measures||ng/mL||Full Range|Geometric Mean
792823|NCT00897390|Primary|Saxagliptin PK Parameter Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Plasma Concentration (AUC[0-T])|Single-dose PK parameters of saxagliptin were derived from plasma concentration versus time data.|pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|Treated participants with PK measures||ng*h/mL||Full Range|Geometric Mean
792824|NCT00897390|Secondary|BMS-510849 PK Parameter AUC(INF)|Single-dose PK parameters of the active metabolite of saxagliptin, BMS-510849, were derived from plasma concentration versus time data.|pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|Treated participants with PK measures||ng*h/mL||Full Range|Geometric Mean
792825|NCT00897390|Primary|Saxagliptin Pharmacokinetic (PK) Parameter Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF])|Single-dose PK parameters of saxagliptin were derived from plasma concentration versus time data.|pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|Treated participants with PK measures||ng*h/mL||Full Range|Geometric Mean
792826|NCT00897715|Secondary|Change in Concentration of Interleukin-6 (IL-6) From Baseline to 12 Weeks|IL-6 is a sensitive laboratory assay for serum levels of Interleukin-6, which is a pro-inflammatory cytokine that is used to evaluate the inflammatory response|baseline and 12 weeks|The number of participants for analysis was based on those subjects who completed the 12-week study, as well as 2 subjects who withdrew but completed end-of-study procedures (1 in each group). The analysis was per protocol. Note that the results reported here are only based on the subjects enrolled at the VA Nashville||pg/ml||Inter-Quartile Range|Median
792827|NCT00897715|Primary|Change in the Concentration of High Sensitivity C-Reactive Protein (hsCRP) From Baseline to 12 Weeks|hsCRP is a sensitive laboratory assay for serum levels of C-Reactive Protein, which is a biomarker of inflammation|baseline and 12 weeks|The number of participants for analysis was based on those subjects who completed the 12-week study, as well as 2 subjects who withdrew but completed end-of-study procedures (1 in each group). The analysis was per protocol. Note that the results reported here are only based on the subjects enrolled at the VA Nashville.||mg/dl||Inter-Quartile Range|Median
792828|NCT00897897|Secondary|Fibroid Symptom Severity Score (SSS) From the Uterine Fibroid Symptoms - Quality of Life (UFS-QoL) Questionnaire.|"Mean absolute change in the Symptom Severity Score (SSS) of the Uterine Fibroid Symptoms - Quality of Life (UFS-QoL) questionnaire after fibroid treatment with HIFU.
The SSS is a scale from 0-100, where 0 corresponds to no symptoms and 100 corresponds to the most severe symptoms."|At baseline and at 30 days following treatment|||scores on a scale||Standard Deviation|Mean
792829|NCT00897897|Primary|Adverse Events/Subject Resulting From HIFU Treatment of the Uterine Fibroids|The number of Adverse Events reported during the study, divided by the total number of treated subjects. This corresponds to the mean number of Adverse Events per subject.|30 days after treatment|||Adverse Event/subject||Standard Deviation|Mean
792830|NCT00897910|Secondary|Cell Counts of Myeloma-specific T Cells ex Vivo Expanded Before and After CD3/CD28 Stimulation||Collection of PBMCs over a period of 9-12 months, and the laboratory component will be performed over another year.||||||
792831|NCT00897910|Primary|Percentage of Myeloma-specific T Cells ex Vivo Expanded Using Flow Cytometry||Collection of PBMCs over a period of 9-12 months, and the laboratory component will be performed over another year.||||||
792832|NCT00897949|Secondary|Pain Relief 2 Hours After Treatment for Headache Recurrence|Patients reporting pain relief 2 hours after treatment for headache recurrence (defined as the return of headache to grade 2 or 3 within 24 hours of the initial dose in patients who reported pain relief (grades 0 or 1) at 2 hours).|2 hours after treatment for recurrence|Patients with initial headache recurrence who took rizatriptan 5 mg or 10 mg were prerandomized (ratio=1:1) to either rizatriptan 5 mg or 10 mg, respectively, or to placebo (ratio=1:1); and who took placebo, to either 5 mg or 10 mg of rizatriptan (ratio=1:1). Only those who took rizatriptan for their initial headache were considered for analysis.||Participants|||Number
792833|NCT00897949|Secondary|Use of Escape Medication at 2 Hours After the Initial Dose of Test Drug||2 hours after initial dose of test drug|An “all-patients-treated” approach was employed that included all patients who had at least one record of pain severity within 2 hours after the initial dose. Missing data were replaced by carrying forward the preceding value.||Participants|||Number
792834|NCT00897949|Secondary|No Disability at 2 Hours After the Initial Dose of Test Drug|Patients with no disability at 2 hours after the initial dose of test drug. Functional disability was subjectively rated on a scale from grade 0 to 3: Grade 0 – Normal, Grade 1 - Daily activities mildly impaired, Grade 2 - Daily activities severely impaired, Grade 3 - Unable to carry out daily activities, requires bedrest|2 hours after initial dose of test drug|An “all-patients-treated” approach was employed that included all patients who had at least one record of functional disability within 2 hours after the initial dose. Missing data were replaced by carrying forward the preceding value.||Participants|||Number
792835|NCT00897949|Secondary|Pain Free at 2 Hours After the Initial Dose of Test Drug|Patients reporting pain free (defined as a reduction of headache severity to grade 0 [no pain]) at 2 hours after the initial dose of test drug. Pain severity was subjectively rated by patients on a scale from grade 0 to 3: Grade 0 - No headache, Grade 1 - Mild pain, Grade 2 - Moderate pain, Grade 3 - Severe pain.|2 hours after initial dose of test drug|An “all-patients-treated” approach was employed that included all patients who had at least one record of pain severity within 2 hours after the initial dose. Missing data were replaced by carrying forward the preceding value.||Participants|||Number
792907|NCT00899717|Secondary|Preferred Chewing Side|The change in the habitual chewing side of each participant across the study|Before and 6 months after therapy|||participants|||Number
792836|NCT00897949|Primary|Pain Relief at 2 Hours After the Initial Dose of Test Drug|Patients reporting pain relief (defined as a reduction of headache severity from grades 2/3 at baseline to 0/1) at 2 hours after the initial dose of test drug. Pain severity was subjectively rated by patients on a scale from grade 0 to 3: Grade 0 - No headache, Grade 1 - Mild pain, Grade 2 - Moderate pain, Grade 3 - Severe pain.|2 hours after initial dose of test drug|The primary analysis employed an “all-patients-treated” approach that included all patients who had at least one record of pain severity within 2 hours after the initial dose. Missing data were replaced by carrying forward the preceding value.||Participants|||Number
792837|NCT00898222|Primary|Change in Exhaled Inflammatory Mediator Levels|Descriptive statistics|baseline and 6 months|||pg/mL||Full Range|Mean
792838|NCT00898443|Secondary|Impact of Anesthesia Type on OR (Operating Room) Efficiency|The time minutes)from initiation of anesthesia to surgery start.|minutes until surgery start|Only the patients who were recruited, randomized and had all their data completed at the time of their procedure were included in the analysis. Insufficient numbers were recruited to complete the study as designed.||minutes||Full Range|Median
792839|NCT00898443|Primary|Success Rate of Reactivation of Existing Continuous Labor Epidural Catheter for Postpartum Tubal Ligation|Rate of reactivation of the epidural catheter for postpartum tubal ligation in the group that was randomized to the epidural anesthetic group. (Need for additional supplemental analgesics and sedatives or the need to convert to general anesthesia.)|at the time of surgery|Only the patients who were recruited, randomized and had all their data completed at the time of their procedure were included in the analysis. Insufficient numbers were recruited to complete the study as designed.||participants|||Number
792840|NCT00898560|Secondary|AUC0-∞ - Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity|To investigate whether multiple-dose administration of eslicarbazepine acetate (ESL, BIA 2-093) 800 mg once-daily (QD) affects the pharmacokinetics of the components of a combined oral contraceptive (ethinyloestradiol and levonorgestrel).|15-day|||ng.h/mL||Standard Deviation|Mean
792841|NCT00898560|Secondary|AUC0-t - Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Sampling Time at Which Concentrations Were at or Above the Limit of Quantification|To investigate whether multiple-dose administration of eslicarbazepine acetate (ESL, BIA 2-093) 800 mg once-daily (QD) affects the pharmacokinetics of the components of a combined oral contraceptive (ethinyloestradiol and levonorgestrel).|15-day|||ng.h/mL||Standard Deviation|Mean
792842|NCT00898560|Primary|Cmax - Maximum Observed Plasma Concentration|To investigate whether multiple-dose administration of eslicarbazepine acetate (ESL, BIA 2-093) 800 mg once-daily (QD) affects the pharmacokinetics of the components of a combined oral contraceptive (ethinyloestradiol and levonorgestrel).|15-day|||pg/mL||Standard Deviation|Mean
792843|NCT00898677|Secondary|Nausea at 2 Hours After Dose|Patients who recorded the presence or absence of nausea 2 hours after dose|2 hours after dose|An “all-patients-treated” approach was used in the secondary analysis. Missing data were replaced by carrying forward the preceding value.||participants|||Number
792844|NCT00898677|Secondary|Functional Status at 2 Hours After Dose|Patients with no functional disability measured by the level of impairment to daily activities at 2 hours after treatment. Each patient rated functional disability on a 4-grade scale (0 = no functional disability; 1 = daily activities mildly impaired; 2 = daily activities severely impaired; 3 = unable to carry out daily activities, requires bed rest).|2 hours after dose|An “all-patients-treated” approach was used in the secondary analysis. Missing data were replaced by carrying forward the preceding value.||Participants|||Number
792845|NCT00898677|Secondary|Pain Free at 2 Hours After Dose|Patients pain free (defined as a reduction of headache severity to grade 0 [no pain]) at 2 hours after treatment. Each patient rated headache severity on a 4-point scale (0 = no headache; 1 = mild pain; 2 = moderate pain; 3 = severe pain).|2 hours after dose|An “all-patients-treated” approach was used in the secondary analysis, including all patients who had at least one assessment of pain severity within 2 hours after test medication. Missing values in the treatment phase (i.e., after the baseline phase) were imputed by carrying forward the preceding values in the same phase.||Participants|||Number
792846|NCT00898677|Primary|Time to Relief Within 2 Hours After Dose|Patients reporting time to relief defined as the first time point at which a patient reported headache severity grade 1 or 0 (mild pain or no headache) within 2 hours after dose|within 2 hours after dose|An “all-patients-treated” approach was used in the primary analysis, including all patients who had at least one assessment of pain severity within 2 hours after test medication.||Participants|||Number
792847|NCT00898677|Primary|Pain Relief at 2 Hours After Dose|Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe pain) at baseline to grades 0 or 1 (no headache or mild pain) at 2 hours after treatment|2 hours after dose|An “all-patients-treated” approach was used in the primary analysis, including all patients who had at least one assessment of pain severity within 2 hours after test medication. Missing values in the treatment phase (i.e., after the baseline phase) were imputed by carrying forward the preceding values in the same phase.||Participants|||Number
792848|NCT00898807|Secondary|Neuropsychiatric Inventory (NPI)-- Agitation Subscore|NPI agitation score is based on responses from an informed caregiver involved in the patient's life. Symptom severity (1=mild, 2=moderate, 3=severe) is multiplied by frequency (1=occasionally, less than once/week; 4 = very frequently, once or more/day or continuously) to obtain the NPI agitation score.Range is 0-12. Higher scores indicate more severe symptoms.|9 weeks|"The primary analysis was an intention-to-treat analysis; analysis was conducted as randomized. Data from the 186 randomized participants were used in the analytic model. 169 of the 186 patients had week 9 data."||units on a scale||Standard Deviation|Mean
792849|NCT00898807|Secondary|Cohen-Mansfield Agitation Inventory (CMAI)|CMAI examines several agitated behaviors including verbal, physical agitation, and other behaviors. Sub-items are summed. Range is 14-70. Higher scores indicate more severe symptoms.|9 weeks|"The primary analysis was an intention-to-treat analysis; analysis was conducted as randomized. Data from the 186 randomized participants were used in the analytic model. 169 of the 186 patients had week 9 data."||units on a scale||Standard Deviation|Mean
792908|NCT00899717|Secondary|Symptom Checklist-90-Revised (SCL-90-R®)|Scale name: Global Severity Index. Scale graded from 0 to 4. Scores increases as the symptoms severity increases.|Before and 6 months after therapy|Only tests from 15 participants were suitable because of slow or too many positive responses.||units on a scale||Standard Deviation|Mean
792850|NCT00898807|Primary|Modified Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change in Agitation(CGIC)|Modified Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change in agitation(CGIC) accesses clinically significant change in agitation. A trained clinician, blind to treatment assignment, uses a 7-point Likert scale to rate change of each patient along a continuum from “marked improvement”(1), “no change”(4), and “marked worsening”(7). A number of aspects of the agitation is considered such as emotional agitation, mood liability/distress, psychomotor agitation, verbal aggression, and physical aggression. Range is 1-7.|Baseline to 9 weeks|"The primary analysis was an intention-to-treat analysis; analysis was conducted as randomized. Data from the 186 randomized participants were used in the analytic model. 167 of the 186 patients had week 9 data on CGIC."||percentage moderate/marked improvement|||Number
792851|NCT00898807|Primary|NeuroBehavior Rating Scale-- Agitation|NeuroBehavioral Rating Scale- Agitation(NBRS-A) assesses multiple types of psychopathology common in dementia and is based on a seven point Likert scale of increasing severity for each item(i.e., 0=not present, 1=very mild, 2-mild, 3=moderate, 4=moderately severe, 5=severe, 6=extremely severe). The NBRS agitation subscore includes NBRS 'inhibition’, ‘agitation’, and ‘hostility’. The range is 0 to 18 points. Higher scores indicate more symptoms.|9 weeks|"The primary analysis was an intention-to-treat analysis; analysis was conducted as randomized. Data from the 186 randomized participants were used in the analytic model. 167 of the 186 patients had week 9 data on the NBRS."||units on a scale||Standard Error|Mean
792852|NCT00891436|Secondary|Histamine Content in the Tears Was Measured.|Tear samples were assayed for histamine by ELISA|Samples taken at initial visit & 2 week follow-up|All participants had tears measured for histamine.||ng/ml||Standard Error|Mean
792853|NCT00891436|Primary|Eosinophilic Cationic Protein (ECP) Levels|Tear samples from the participants eyes were collect and were to be used for measuring esinophilic cationic prtein, but this was not measured because the volume of tears were to low.|Samples taken at initial visit & 2 week follow-up|Tear samples from the participants eyes were collect and were to be used for measuring esinophilic cationic prtein, but this was not measured because the volume of tears were to low.|||||
792854|NCT00891462|Secondary|Change From Baseline in Peak Forced Expiratory Volume in 1 Second (FEV1)|Change From Baseline in Peak FEV1 (L) at Week 12, Last Observation Carried Forward (LOCF)|Change from Baseline to 12 weeks|Of 561 patients randomized, 560 patients received at least 1 dose of double-blind treatment and therefore were included in the Safety Population. Of these patients, 559 had a baseline and at least 1 postbaseline FEV1 assessment and qualified for the Intent to Treat (ITT) Population. The primary efficacy endpoint was based on ITT population.||L||Standard Error|Least Squares Mean
792855|NCT00891462|Primary|Change From Baseline in Morning Pre-dose Forced Expiratory Volume in 1 Second (FEV1)|Change from baseline in trough forced expiratory volume in 1 second before the morning dose of aclidinium bromide, Last Observation Carried Forward (LOCF)|Change from Baseline to 12 weeks|Of 561 patients randomized, 560 patients received at least 1 dose of double-blind treatment and therefore were included in the Safety Population. Of these patients, 559 had a baseline and at least 1 postbaseline FEV1 assessment and qualified for the Intent to Treat (ITT) Population. The primary efficacy endpoint was based on ITT population.||L||Standard Error|Least Squares Mean
792856|NCT00891527|Secondary|Stabilization at 48 Weeks||48 weeks|||Participants|||Count of Participants
792857|NCT00891527|Secondary|Progression at 48 Weeks||48 weeks|||Participants|||Count of Participants
792858|NCT00891527|Primary|Survival at 48 Weeks||48 weeks|||Participants|||Count of Participants
792859|NCT00899353|Primary|The Degree of Change in Tumor Mass Measurements During and After Omega-3 Supplementation as Evaluated by Standard Clinical Tests of Disease Activity.|"Patients diagnosed with early stage (asymptomatic) CLL were supplemented with escalating doses of omega-3 (n-3) fatty acids (2.4 g of n-3/day up to 7.2 g of n-3/day). Given that these patients are asymptomatic and did not require treatment, measures of tumor mass during and after omega-3 supplementation, as evaluated by standard clinical tests of disease activity, were not performed. Instead, absolute lymphocyte counts (ALC), as a measure of tumor burden, was evaluated before and after omega-3 supplementation. Data represents the fold change in ALC post omega-3 consumption as compared to baseline ALC.
Patients with MGUS or SMM were not enrolled into this study."|Baseline, month 1, month 2, month 3, month 6, month 9, 12 months|Patients who's absolute lymphocyte counts were known prior to omega-3 initiation (baseline) and after omega-3 consumption were included in this analysis. Patients who's ALC was unknown prior to omega-3 initiation or after omega-3 consumption were excluded.||Fold Change|||Number
792860|NCT00899353|Primary|Activated Nuclear Factor Kappa B (NFkB) in Peripheral Blood Lymphocytes From Patients With Early Stage Chronic Lymphocytic Leukemia (CLL) Before, During and After Consumption of an Omega 3 Supplement.|Peripheral lymphocytes were isolated from the blood using Ficoll-Paque gradient. Nuclear Factor Kappa B activation was analyzed using Thermo Scientific Transcription Factor kit for NFkB p50, according to manufacturer’s protocol. Protein extracts containing 1-15µg of protein/well were added in triplicates. Luminescence resulting from a reaction with bound NFkB was detected using a Berthold Centro LB960 Luminometer and analyzed with MikroWin 2000 ver. 1.08. NFkB activity was normalized by luminescence units/µg of protein per well.|baseline, and post supplement month 1(3 capsules/day), month 2 (6capsules/day), month 3 (9 capusules/day), month 6 (9 capusules/day), month 9 (9 capusules/day), month 12 (post supplement)|NFkB activation of all patients diagnosed with early stage CLL at baseline and following omega 3 consumption. Patients are further separated into high (> median, n=7) and low initial baseline (< median, n=6) NFkB. Patients included must have had one baseline and at least one period of omega 3 consumption. Not all patients completed all periods||10^6 NFkB Luminescence units/µg protein||Standard Error|Mean
792861|NCT00899379|Secondary|Pain Relief at 2 Hours During the Fourth Migraine Attack Period|Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe) to grades 0 or 1 (no headache or mild) at 2 hours after dosing for the fourth migraine attack|2 hours|The secondary efficacy analysis used an all-patients-treated approach which included all patients who had at least one record of an efficacy measure after the initial dose. Missing values were imputed by carrying forward the preceding values in the same phase. Values were not carried forward from one attack period to the next.||Participants|||Number
792909|NCT00899717|Primary|Visual Analogic Scale for Pain Intensity (0-10)|"The primary outcome was self-reported pain intensity on a 0 to 10 cm visual analog scale considering the temporomandibular disorder side, being 0=No pain and 10=Worst imaginable pain"|Baseline, immediately after therapy, 3 months and 6 months after therapy|||units on a scale||Standard Deviation|Mean
792862|NCT00899379|Secondary|Pain Relief at 2 Hours During the Third Migraine Attack Period|Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe) to grades 0 or 1 (no headache or mild) at 2 hours after dosing for the third migraine attack|2 hours|The secondary efficacy analysis used an all-patients-treated approach which included all patients who had at least one record of an efficacy measure after the initial dose. Missing values were imputed by carrying forward the preceding values in the same phase. Values were not carried forward from one attack period to the next.||Participants|||Number
792863|NCT00899379|Secondary|Pain Relief at 2 Hours During the Second Migraine Attack Period|Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe) to grades 0 or 1 (no headache or mild) at 2 hours after dosing for the second migraine attack|2 hours|The secondary efficacy analysis used an all-patients-treated approach which included all patients who had at least one record of an efficacy measure after the initial dose. Missing values were imputed by carrying forward the preceding values in the same phase. Values were not carried forward from one attack period to the next.||Participants|||Number
792864|NCT00899379|Primary|Pain Relief at 2 Hours During the First Migraine Attack Period|Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe) at baseline to grades 0 or 1 (no headache or mild) at 2 hours after initial dosing for the first migraine attack|2 hours|The primary efficacy analysis used an all-patients-treated approach which included all patients who had at least one record of an efficacy measure after the initial dose. Missing values were imputed by carrying forward the preceding values in the same phase.||participants|||Number
792865|NCT00899392|Secondary|GI Suite Flow Efficiency Measured in 15 Minute Increments||At completion of study||||||
792866|NCT00899392|Secondary|Questions Asked by Subjects (Parents)|Number of questions written down by family and asked of clinician. Question sheet given to nurse in endoscopy suite and deposited in a box.|Questions written by parents during the end of consent process (48-72 hours)|||Questions||Full Range|Mean
792867|NCT00899392|Secondary|Subject (Parental) State Anxiety as Measured by the Spielberger-State Trait Anxiety Inventory (s-STAI) (State Section)|s-STAI as a series of question administered by laptop computer in private. 20 questions answered on Likert 4 point scale that varies based on question type. Max score 80.|12-18 hours (Night before Endoscopy to Day of Endoscopy)|Matched pairs (pre consent and post consent), Pilot data included to increase power analysis||Units on a Scale (STAI Score)||Standard Deviation|Mean
792868|NCT00899392|Secondary|Subject (Parental) Satisfaction as Measured by Modified Group Health Association of America-9 Survey (mGHAA-9)|Worse Value: 5 Best Value 45 Measures satisfaction on a scale per the mGHAA-9. 9 questions administered on a laptop in private.|Every 1-2 months|(Consent Group + some pilot participants to increase power of analysis)||Units on a scale||Standard Deviation|Mean
792869|NCT00899392|Primary|Attainment of Informed Consent as Measured by Consent Instrument (Consent-20)|"Units on a scale (score) as Measured by Consent 20 Instrument.
20 questions administered on a laptop computer and answered in private. Questions 1-5: qualitative questions about recalling procedure, risks, benefits, etc. (correct or incorrectly scored 0 or 2 points), Questions 6-20: yes or no responses, measuring delivery, voluntariness, and understanding. Each scored 0 or 2 points.
Measures theoretical attainment of a minimum standard of informed consent. Worse value: Zero Best Value: 40"|Every 1-2 months|||Units on a scale||Standard Deviation|Mean
792870|NCT00899470|Secondary|Number of Participant With Clinically Relevant Physical Examination Abnormalities|A physical examination was conducted which included height and weight measurements, from which the Body Mass Index was determined. Physical examination abnormalities were judged to be of medical importance by the Investigator.|Screen, Period 1 Day -1, prior to discharge|All Treated Participants||participants|||Number
792871|NCT00899470|Secondary|Number of Participants With Clinically Relevant Vital Sign Abnormalities|Mean systolic and diastolic blood pressure, heart rate, respiration, and temperature were assessed.Vital sign abnormalities abnormalities were judged to be of medical importance by the Investigator.|Period 1 Day 1, Period 2 Day 1, Period 3 Day 1, Period 4 Day 1, Period 4 Day 3|All Treated Participants||participants|||Number
792872|NCT00899470|Secondary|Number of Participants With Clinically Relevant Electrocardiogram (ECG) Abnormalities|PR interval, QRS complex, width of QRS, QT interval, and QT corrected for heart rate adjusting for heart rate using either Bazett formula or Fridericia formula were measured. ECG abnormalities were judged to be of medical importance by the Investigator.|Period 1 Day 1, Period 2 Day 1, Period 3 Day 1, Period 4 Day 1, Period 4 Day 3|All Treated Participants||participants|||Number
792873|NCT00899470|Secondary|Number of Participants With Laboratory Marked Abnormalities|High=greater than Upper Normal Limit (ULN), Low=lower than Lower Normal Limit (LLN). LLN/ULN= Leukocytes: <0.9 x LLN/ >1.2 x ULN; blood urea nitrogen (BUN): >1.1 x ULN; creatinine: >1.33 x BL; phosphorous (P): <0.75 x LLN/ >1.2 5 x ULN; creatinine kinase (CK): >1.5 x ULN; urine blood=use ≥2 x BL if value ≥2+ or BL1+|From Day 1 through Day 45, including up to 56 days after last dose of study medication|All Treated Participants||participants|||Number
792874|NCT00899470|Secondary|Number of Participants With at Least 1 Adverse Event (AE), Death, Serious AE (SAE), or AEs Leading to Discontinuation|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|From Day 1 through Day 45, including up to 56 days after last dose of study medication|All Treated Participants||participants|||Number
792875|NCT00899470|Secondary|BMS-510849 Mean T-half and T-max|T-half and Tmax of the saxagliptin metabolite BMS-510849, following single-dose saxagliptin (2.5 mg) coadministered with metformin IR (500 mg) or administerd as an FDC 2.5 mg saxagliptin/500 mg metformin IR tablet, under fasted and fed conditions.|Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr|PK data set, all participants who received study drug||hours||Standard Deviation|Mean
792910|NCT00900029|Primary|Number of Subjects With Target Wound Closed for the First Time During the Study Period.|At each visit the status of open target ulcers was evaluated as “remained open” or “closed”.|Over the 24-week study period, at each of the bi-monthly visits|Subjects who completed the 802-247-09-015 study with open target wound attended three bimonthly visits over the duration of the study.||participants|||Number
792876|NCT00899470|Secondary|BMS-510849 Mean AUC (0-INF)|AUC (0-T)= for the saxagliptin metabolite BMS-510849, following single-dose saxagliptin (2.5 mg) coadministered with metformin IR (500 mg) or administered as an FDC 2.5 mg saxagliptin/500 mg metformin IR tablet, under fasted and fed conditions.|Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr|PK data set, all participants who received study drug||ng*h/mL||Standard Deviation|Mean
792877|NCT00899470|Secondary|BMS-510849 Mean AUC (0-T)|AUC (0-T) for the saxagliptin metabolite BMS-510849, following single-dose saxagliptin (2.5 mg) coadministered with metformin IR (500 mg) or administration as an FDC 2.5 mg saxagliptin/500 mg metformin IR tablet, under fasted and fed conditions.|Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr|PK data set, all participants who received study drug||ng*h/mL||Standard Deviation|Mean
792878|NCT00899470|Secondary|BMS-510849 Mean Cmax|Cmax of the saxagliptin metabolite BMS-510849, following single-dose saxagliptin (2.5 mg) coadministered with metformin IR (500 mg) or administered as an FDC 2.5 mg saxagliptin/500 mg metformin IR tablet, under fasted and fed conditions.|Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr|PK data set, all participants who received study drug||ng/mL||Standard Deviation|Mean
792879|NCT00899470|Primary|Metformin T-half and T-max|T-half and T-max for single-dose metformin IR (500 mg), either coadministered with saxagliptin (2.5 mg), or administerd as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.|Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr|PK data set, all participants who received study drug||hours||Standard Deviation|Mean
792880|NCT00899470|Primary|Metformin Mean AUC(0-INF)|AUC (0-INF) for single-dose metformin IR (500 mg), either coadministered with saxagliptin (2.5 mg) or administerd as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.|Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr|PK data set, all participants who received study drug||ng*h/mL||Standard Deviation|Mean
792881|NCT00899470|Primary|Metformin Mean AUC (0-T)|AUC (0-T for single-dose metformin (500 mg), either coadministered with saxagliptin (2.5 mg) or administerd as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.|Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr|PK data set, all participants who received study drug||ng*h/mL||Standard Deviation|Mean
792882|NCT00899470|Primary|Metformin Mean Cmax|Cmax of single-dose metformin IR (500 mg), either coadministered with saxagliptin (2.5 mg) or administerd as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.|Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr|PK data set, all participants who received study drug||ng/mL||Standard Deviation|Mean
792883|NCT00899470|Primary|Saxagliptin Mean Plasma Half-life (T-half) and Mean Time of Maximum Observed Plasma Concentration (T-max)|T-half and T-max for single-dose saxagliptin (2.5 mg), either coadministered with metformin IR (500 mg) or administered as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.|Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr|PK data set, all participants who received study drug||hours||Standard Deviation|Mean
792884|NCT00899470|Primary|Saxagliptin Mean Area Under the Plasma Concentration Time Curve From Time Zero To Infinity (AUC [0-INF])|AUC (0-T) for single-dose saxagliptin (2.5 mg), either coadministered with metformin IR (500 mg), or administered as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.|Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr|PK data set, all participants who received study drug||ng*h/mL||Standard Deviation|Mean
792885|NCT00899470|Primary|Saxagliptin Mean Area Under the Plasma Concentration Time Curve From Time Zero To Time of Last Quantifiable Concentration (AUC [0-T]}|AUC (0-T) for single-dose saxagliptin (2.5 mg), either coadministered with metformin IR (500 mg), or administered as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.|Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr|PK data set, all participants who received study drug||ng*h/mL||Standard Deviation|Mean
792886|NCT00899470|Primary|Saxagliptin Mean Maximum Observed Plasma Concentration (Cmax)|Cmax of single-dose saxagliptin (2.5 mg), either coadministered with metformin IR (500 mg), or administered as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.|Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr|PK data set, all participants who received study drug||ng/mL||Standard Deviation|Mean
792887|NCT00899574|Secondary|Clinical Benefits|This outcome measure is defined as number of patients with improvement of symptoms after 8 weeks of treatment.|9 weeks|Patients who completed 1 cycle of treatment (8 weeks) and response evaluation at week 9.||patients|||Number
792888|NCT00899574|Primary|Objective Response (Complete Clinical Response+ Partial Response)|This is defined as percentage of patients who achieved complete clinical response or partial response at end of cycle 1 of treatment. The tumor size will be measured as lesion surface area (region of interest, ROI). The response to the treatment is then evaluated as a function of post-treatment over pre-treatment ROI, expressed in percentage. Response criteria for this study are based on European Organisation for Research and Treatment of Cancer definitions for chest wall tumors: complete clinical response: absence of any detectable residual disease; partial response: <50% of ROI change.|9 weeks|Patients who completed 1 cycle of treatment (8 weeks) and response evaluation at week 9.||percentage of patients||95% Confidence Interval|Number
792889|NCT00899600|Secondary|Complications Related to Ketamine||24 and 48 hours||||||
792890|NCT00899600|Secondary|Hemodynamic Changes||24 and 48 hours||||||
792891|NCT00899600|Secondary|Mortality||1 year||||||
792892|NCT00899600|Secondary|Hospital Duration||24 and 48 hours||||||
792893|NCT00899600|Primary|Morphine Consumption in the First 48 Hours After Surgery|Total morphine(mg)consumed at 48 hours.|48 hours|See methodology||mg||Standard Deviation|Mean
792911|NCT00900029|Primary|The Number of Participants With Closed Target Ulcers at Each Visit|At each visit the status of closed target ulcers was evaluated as remained closed or re-opened.|Over the 24-week study period, at each of the bi-monthly visits|Subjects who completed the 802-247-09-015 study with a closed target wound attended three bimonthly visits.||participants|||Number
792894|NCT00899678|Secondary|Percentage of Subjects in Corticosteroid-free Remission at the End of the Study|Corticosteroid use at end of study is defined as 84 days past the last dose of study medication. Remission is assessed at the last visit where Pediatric Crohn’s Disease Activity index (PCDAI) data is available.|Last/Withdrawal Visit (up to Week 62)|Full Analysis Set (FAS) population. There were only 21 subjects in the Low-Dose group and 20 subjects in the High-Dose group who took steroids during the Maintenance Period.||percentage of paticipants||95% Confidence Interval|Number
792895|NCT00899678|Secondary|Percentage of Subjects Who Initiated Steroid Tapering|Subjects receiving corticosteroids at Screening may start a defined tapering schedule between Weeks 2 and 8. Corticosteroid tapering must start at the latest by Week 8. Corticosteroid doses are tapered at different rates depending on the subject’s dose.|From Week 2 up to Week 8|Full Analysis Set (FAS) population. There were only 21 subjects in the Low-Dose group and 20 subjects in the High-Dose group who took steroids during the Maintenance Period.||percentage of subjects||95% Confidence Interval|Number
792896|NCT00899678|Secondary|Change in Growth Scores (Tanner Stage [Assessing Puberty]) From Week 0 to the End of the Study (Week 62)|The Tanner stage is an assessment of developmental stage on external genitalia and pubic hair (boys), and on breast and pubic hair (girls). Values range from 1 to 5 where a higher number indicates more development.|From Week 0 to Week 62|Full Analysis Analysis (FAS) population. At the start of the Maintenance Period, the FAS had 37 subjects in the Low-Dose group and 35 subjects in the High- Dose group. However, at Week 62, there were only 10 subjects in the Low-Dose group and 7 subjects in the High-Dose group with valid Growth scores.||participants|||Number
792897|NCT00899678|Secondary|Change in Erythrocyte Sedimentation Rate (ESR) From Week 0 to the End of the Study (Week 62)|"The Erythrocyte Sedimentation Rate (ESR) is a considered biomarker of inflammation in subjects with Crohn’s Disease (CD).
Changes from Baseline in CRP levels are expressed as a ratio with the value measured at baseline as the denominator."|From Week 0 to Week 62|Full Analysis Set (FAS) population. At the start of the Maintenance Period, the FAS had 37 subjects in the Low-Dose group and 35 subjects in the High- Dose group. However, at Week 62, there were only 12 subjects in the Low-Dose group and 7 subjects in the High-Dose group with a valid Erythrocyte Sedimentation Rate (ESR).||ratio||95% Confidence Interval|Geometric Mean
792898|NCT00899678|Secondary|Erythrocyte Sedimentation Rate (ESR) at Week 62|The Erythrocyte Sedimentation Rate (ESR) is a considered biomarker of inflammation in subjects with Crohn’s Disease (CD).|Week 62|Full Analysis Set (FAS) population. At the start of the Maintenance Period, the FAS had 37 subjects in the Low-Dose group and 35 subjects in the High- Dose group. However, at Week 62, there were only 12 subjects in the Low-Dose group and 7 subjects in the High-Dose group with a valid Erythrocyte Sedimentation Rate (ESR).||mm/h||95% Confidence Interval|Geometric Mean
792899|NCT00899678|Secondary|Change in C-Reactive Protein (CRP) Levels From Week 0 to the End of the Study (Week 62)|"The C-Reactive Protein (CRP) is a considered marker of inflammation in subjects with Crohn’s Disease (CD).
Changes from Baseline in CRP levels are expressed as a ratio with the value measured at Baseline as the denominator."|From Week 0 to Week 62|Full Analysis Set (FAS) population. At the start of the Maintenance Period, the FAS had 37 subjects in the Low-Dose group and 35 subjects in the High- Dose group. However, at Week 62, there were only 11 subjects in the Low-Dose group and 7 subjects in the High-Dose group with valid C-Reactive Protein (CRP) levels.||ratio||95% Confidence Interval|Geometric Mean
792900|NCT00899678|Secondary|C-Reactive Protein (CRP) Levels at Week 62|The C-Reactive Protein (CRP) is a considered marker of inflammation in subjects with Crohn’s Disease (CD)|Week 62|Full Analysis Set (FAS) population. At the start of the Maintenance Period, the FAS had 37 subjects in the Low-Dose group and 35 subjects in the High- Dose group. However, at Week 62, there were only 11 subjects in the Low-Dose group and 7 subjects in the High-Dose group with valid C-Reactive Protein (CRP) levels.||mg/L||95% Confidence Interval|Geometric Mean
792901|NCT00899678|Secondary|Percentage of Subjects Achieving Clinical Response From Week 0 to the End of the Study (Week 62)|"Clinical response is defined as a decrease from Week 0 in Pediatric Crohn’s Disease Activity Index (PCDAI) score of ≥ 15 points and a total PCDAI score ≤ 30 points.
The Pediatric Crohn’s Disease Activity Index (PCDAI) consists of 4 domains (laboratory, height/weight, examination, and history) with several assessments that are converted into a PCDAI score which can range from 0 to 100 points, with a higher score indicating more severe disease activity."|From Week 0 to Week 62|Full Analysis Set (FAS) population||percentage of participants||95% Confidence Interval|Number
792902|NCT00899678|Secondary|Change in Pediatric Crohn's Disease Activity Index (PCDAI) Scores From Week 0 to the End of the Study (Week 62)|"The Pediatric Crohn's Disease Activity Index (PCDAI) consists of 4 domains (laboratory, height/weight, examination, and history) with several assessments that are converted into a PCDAI score which can range from 0 to 100 points, with a higher score indicating more severe disease activity.
A negative value in change from Baseline indicates an improvement from Baseline to Week 62."|From Week 0 to Week 62|Full Analysis Set (FAS) population. At the start of the Maintenance Period, the FAS had 37 subjects in the Low-Dose group and 35 subjects in the High- Dose group. However, at Week 62, there were only 11 subjects in the Low-Dose group and 7 subjects in the High-Dose group with valid Pediatric Crohn's Disease Activity Index (PCDAI) scores.||units on a scale||Standard Deviation|Mean
792903|NCT00899678|Secondary|Absolute Pediatric Crohn’s Disease Activity Index (PCDAI) Scores at Week 62|The Pediatric Crohn’s Disease Activity Index (PCDAI) consists of 4 domains (laboratory, height/weight, examination, and history) with several assessments that are converted into a PCDAI score which can range from 0 to 100 points, with a higher score indicating more severe disease activity.|Week 62|Full Analysis Set (FAS) population. At the start of the Maintenance Period, the FAS had 37 subjects in the Low-Dose group and 35 subjects in the High-Dose group. However, at Week 62, there were only 11 subjects in the Low-Dose group and 7 subjects in the High-Dose group with valid Pediatric Crohn's Disease Activity Index (PCDAI) scores.||Score on a scale||Standard Deviation|Mean
792904|NCT00899678|Primary|Percentage of Subjects in Clinical Remission at Week 62|"Clinical remission is defined as a Pediatric Crohn’s Disease Activity Index (PCDAI) score ≤ 10.
The Pediatric Crohn’s Disease Activity Index (PCDAI) consists of 4 domains (laboratory, height/weight, examination, and history) with several assessments that are converted into a PCDAI score which can range from 0 to 100 points, with a higher score indicating more severe disease activity."|Week 62|Full Analysis Set (FAS) population||percentage of participants||95% Confidence Interval|Number
792905|NCT00899717|Secondary|Condylar Path Angles|Parasagittal plane condylar path angles tracings in relation to the Frankfort line were made following the Gysi extraoral method.|Baseline|||degrees||Standard Deviation|Mean
792912|NCT00900146|Primary|Change From Baseline in Dynamic Phase Secreted Insulin Per Unit of Glucose Concentration (Φd) Over 4 Months (Period III)|This was planned as interim analysis and was not conducted because the study was terminated in period III.|Baseline, Over Month 4|The benefit of canakinumab for the treatment of patients with type 2 diabetes mellitus in combination with metformin was inadequate to continue patients into Period IV in the present study, and therefore decided to terminate the study during Period III.||pmol/min/m2/mmol* hour/L||Standard Error|Least Squares Mean
792913|NCT00900146|Secondary|Percentage Change From Baseline in Fasting Lipids Profile at Month 4 (Period II)|The fasting lipid profiles included triglycerides, total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), calculated very low-density lipoprotein (VLDL), non-HDL cholesterol. Percentage change was measured as [(value at month 4 – baseline value)/baseline value]*100%. The analysis of covariance model included treatment and metformin dose group as main effects and baseline triglycerides, total cholesterol, LDL, HDL, VLDL and non-HDL as covariates.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who randomized in error, did not receive study drug. LOCF method was used for patients without Month 4 data for any reason and who used rescue drug or any other glucose lowering agents other than metformin. 'n' = patients with baseline and endpoints data.||percent change||Standard Error|Least Squares Mean
792914|NCT00900146|Secondary|Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) at Month 4 (Period II)|The change from baseline in hsCRP (on the logarithmic scale) at Month 4 was measured for this analysis. The analysis of covariance included treatment and metformin dose group as main effects and baseline hsCRP as a covariate.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.||log (mg/L)||Standard Error|Least Squares Mean
792915|NCT00900146|Secondary|Change From Baseline in Quantitative Insulin Sensitivity Check Index (QUICKI) at Month 4 (Period II)|The Quantitative Insulin Sensitivity Check Index (QUICKI) score, measures insulin sensitivity which is the inverse of insulin resistance. The score is calculated by the equation: 1 /(log(fasting insulin µU/mL) + log(fasting glucose mg/dL)). In normal subjects, the mean score ± SE is 0.366 ± 0.029. The analysis of covariance included treatment and metformin dose group as main effects and baseline QUICKI as a covariate.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.||units on a scale||Standard Error|Least Squares Mean
792916|NCT00900146|Secondary|Change From Baseline in Homeostatic Model Assessment Insulin Resistance (HOMA2 IR) at Month 4 (Period II)|The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance and beta (β)-cell function. HOMA2-IR is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin resistance which is the reciprocal of insulin sensitivity (%S)(100/%S)as a percentage of a normal reference population (normal young adults). The analysis of covariance included treatment and metformin dose group as main effects and baseline HOMA2 IR as a covariate.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.||percentage of insulin resistance||Standard Error|Least Squares Mean
792917|NCT00900146|Secondary|Change From Baseline in Homeostatic Model Assessment B (HOMA2 B) Beta Cell Function (%B) at Month 4 (Period II)|The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance and beta (β)-cell function. HOMA2-B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state beta cell function (%B) as a percentage of a normal reference population (normal young adults). Time profile of postprandial glucose, insulin and C-peptide were assessed as measures of β-cell response to stimulation. The analysis of covariance included treatment and metformin dose group as main effects and baseline HOMA-B as a covariate.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.||percentage of beta cell function||Standard Error|Least Squares Mean
792918|NCT00900146|Secondary|Change From Baseline in Fasting Insulin at Month 4 (Period II)|Change in fasting insulin Level measured from blood samples taken at Baseline and at Month 4. The analysis of covariance included treatment and metformin dose group as main effects and baseline fasting insulin level as a covariate.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.||pmol/L||Standard Error|Least Squares Mean
792919|NCT00900146|Secondary|Change From Baseline in Fasting Plasma Glucose at Month 4 (Period II)|Change in Fasting Glucose Level measured from plasma taken at Baseline and at Month 4. The analysis of covariance included treatment and metformin dose group as main effects and baseline fasting plasma glucose level as a covariate.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.||mmol/L||Standard Error|Least Squares Mean
792936|NCT00900159|Secondary|EEG-recorded Sleep Efficiency|Polysomnographic recordings of daytime sleep were made at sleep screen (8.5hr) and during daytime sleep episodes of 8.5 hours of duration during treatment visits. Sleep efficiency is calculated based on the time the participant spent in bed and the actual time the participant slept.|On each treatment, during an 8.5-hr daytime sleep episode following at least 3 consecutive night shifts|||percentage of time sleeping||Standard Deviation|Mean
792920|NCT00900146|Secondary|Change From Baseline in Average Plasma Glucose Level (7-point Glucose Testing) at Month 4 (Period II)|Patients were asked to check their glucose level (7 times) using their glucose meter on one of the seven days prior to the Meal Challenge Visits (Period II: Month 0 (Baseline), Month 4. Patient was instructed to test at following timepoints: fasting before breakfast, 2 hours after starting breakfast, before lunch, 2 hours after starting lunch, before dinner, 2 hours after dinner and at bedtime. Patient documented the results in their Study Diary. The analysis of covariance included treatment and metformin dose group as main effects and baseline average plasma glucose level as a covariate.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.||mmol/L||Standard Error|Least Squares Mean
792921|NCT00900146|Secondary|Change From Baseline in Peak Plasma Glucose Level (7-point Glucose Testing) at Month 4(Period II)|Patients were asked to check their glucose level (7 times) using their glucose meter on one of the seven days prior to the Meal Challenge Visits (Period II: baseline, Month 4. Patient was instructed to test at following timepoints: fasting before breakfast, 2 hours after starting breakfast, before lunch, 2 hours after starting lunch, before dinner, 2 hours after dinner and at bedtime. The patient documented the results in their Study Diary. The analysis of covariance included treatment and metformin dose group as main effects and baseline peak plasma glucose level as a covariate.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.||mmol/L||Standard Error|Least Squares Mean
792922|NCT00900146|Secondary|Change From Baseline in 2 Hour Insulin Secretion Rate Derived Based on Glucose and C-peptide Following at Month 4 Following Meal Test (Period II)|A standard liquid mixed-meal challenge was done at baseline and Month 4. A 2 hour insulin secretion rate using deconvolution was performed. The deconvolution was an algorithm that analyzed the insulin secretion rate relative to glucose and C-peptide combined. Blood samples were taken prior to and after meal at sample times: -20, -10, -1 and 10, 20, 30, 60, 90, 120, 180, and 240 minutes relative to the start of the meal. The analysis of covariance included treatment and metformin dose group as main effects and baseline 2 hour Insulin secretion rate as a covariate.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.||pmol/min/m²||Standard Error|Least Squares Mean
792923|NCT00900146|Secondary|Change From Baseline in Insulin Secretion Rates Relative to Glucose AUC (0-2 Hours) at Month 4 Following Meal Test (Period II)|Change in Insulin Secretion Rate stimulated by Liquid mixed-meal challenge. A standard liquid mixed-meal challenge was done at baseline and Month 4. Blood samples were taken prior to and after meal for glucose and insulin at sample times: -20, -10, -1 and 10, 20, 30, 60, 90, 120, 180, and 240 minutes relative to the start of the meal. The model of analysis of covariance included baseline Insulin secretion rate relative to glucose AUC at 0-2 hours as a covariate.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.||pmol/min/m²/mmol *hour/L||Standard Error|Least Squares Mean
792924|NCT00900146|Secondary|Change From Baseline in Peak Insulin Level Following Meal Test (Period II)|A standard liquid mixed-meal challenge was done at baseline and Month 4. Patients fasted overnight after 10 pm on day prior to scheduled visit. Study visits should occur before 10 am. Patients completed each standard meal challenge with measurement of insulin prior to and after a liquid mixed meal. The sampling times were -20, -10, and -1, 10, 20, 30, 60, 90, 120, 150, 180 and 240 minutes relative to the start of meal. The analysis of covariance included treatment and metformin dose group as main effects and baseline 2-hour insulin level as covariate.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.||pmol/L||Standard Error|Least Squares Mean
792925|NCT00900146|Secondary|Change From Baseline in Peak C-peptide Following Meal Test (Period II)|A standard liquid mixed-meal challenge was done at baseline and Month 4. Patients fasted overnight after 10 pm on the day prior to scheduled visit. Study visits should occur before 10 am. Patients completed each standard meal challenge with measurement of C-peptide prior to and after a liquid mixed meal. Sampling times were -20, -10, and -1, 10, 20, 30, 60, 90, 120, 150, 180 and 240 minutes relative to the start of meal. The analysis of covariance included treatment and metformin dose group as main effects and baseline peak C-peptide level as a covariate.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.||nmol/L||Standard Error|Least Squares Mean
792926|NCT00900146|Secondary|Change From Baseline in Peak Glucose Level Following Meal Test (Period II)|A standard liquid mixed-meal challenge was done at baseline and Month 4. Patients fasted overnight after 10 pm on day prior to scheduled visit. Study visits should occur before 10 am. Patients completed each standard meal challenge with measurement of glucose prior to and after a liquid mixed meal. The sampling times were -20, -10, and -1, 10, 20, 30, 60, 90, 120, 150, 180 and 240 minutes relative to the start of meal. The analysis of covariance included treatment and metformin dose group as main effects and baseline peak glucose level as covariate.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.||mmol/L||Standard Error|Least Squares Mean
792927|NCT00900146|Secondary|Change From Baseline in 2-hour Glucose Level Following Meal Test (Period II)|A standard liquid mixed-meal challenge was done at baseline and Month 4. Patients fasted overnight after 10 pm on day prior to scheduled visit. Study visits should occur before 10 am. Patients completed each standard meal challenge with measurement of glucose prior to and after a liquid mixed meal. The sampling times were -20, -10, and -1, 10, 20, 30, 60, 90, 120, 150, 180 and 240 minutes relative to the start of meal. The analysis of covariance included treatment and metformin dose group as main effects and baseline 2-hour glucose level as covariate.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.||mmol/L||Standard Error|Least Squares Mean
792928|NCT00900146|Secondary|Change From Baseline in Insulin Area Under Curve (AUC 0-4 Hours ) Following Meal Test (Period II)|A standard liquid mixed-meal challenge was done at baseline and Month 4. Patients completed each standard meal challenge with measurement of insulin prior to and after a liquid mixed meal. Sampling times were -20, -10, and -1, 10, 20, 30, 60, 90, 120, 150, 180 and 240 minutes relative to the start of meal. Insulin levels over 4 hrs were shown as Area Under the Curve,(AUC). AUC was calculated as: x=1 AUC ΣAx n Where Ax = AUC for the 240 min.interval, and X = 1 for the 1st interval. Model of analysis of covariance included baseline insulin AUC 0-4 hours as covariate.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.||pmol*hour/L||Standard Error|Least Squares Mean
792929|NCT00900146|Secondary|Change From Baseline in Prandial Plasma Glucose Area Under Curve (AUC0-4 Hours ) Following Meal Test (Period II)|A standard liquid mixed-meal challenge was done at baseline and Month 4. Patients completed each standard meal challenge with measurement of glucose prior to and after a liquid mixed meal. Sampling times were -20, -10, and -1, 10, 20, 30, 60, 90, 120, 150, 180 and 240 minutes relative to the start of meal. Glucose levels over 4 hrs were shown as Area Under the Curve,(AUC). AUC was calculated as: x=1 AUC ΣAx n Where Ax = AUC for the 240 min.interval, and X = 1 for the 1st interval. The model of analysis of covariance included baseline plasma glucose AUC 0-4 hours as a covariate.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.||mmol*hour/L||Standard Error|Least Squares Mean
792930|NCT00900146|Secondary|Change From Baseline in C-peptide Area Under Curve (AUC 0-4 Hours ) Following Meal Test (Period II)|A standard liquid mixed-meal challenge was done at baseline and Month 4. Patients completed each standard meal challenge with measurement of C-peptide prior to and after a liquid mixed meal. Sampling times were -20, -10, and -1, 10, 20, 30, 60, 90, 120, 150, 180 and 240 minutes relative to start of meal. C-peptide levels over 4 hrs were shown as Area Under the Curve,(AUC). AUC was calculated as: x=1 AUC ΣAx n Where Ax = AUC for the 240 min.interval, and X = 1 for the 1st interval. The analysis of covariance included baseline C-peptide AUC 0-4 hours as a covariate.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.||nmol*hour/L||Standard Error|Least Squares Mean
792931|NCT00900146|Primary|Change From Baseline in Hemoglobin A1c (HbA1c) at Month 4 During Dose-finding Period of the Study (Period II)|HbA1c was measured by National glycohemoglobin standardization program (NGSP) certified methodology. HbA1c is an integrated measure of average glucose concentration in plasma in the last 2-3 months. The analysis of covariance (ANCOVA) included treatment and metformin dose group as main effects and baseline HbA1c as a covariate.|Baseline, Month 4|The full analysis set (included all randomized patients except for mis-randomized patients who randomized in error but did not receive study drug. Last observation carried forward (LOCF) method was used for patients without Month 4 HbA1c data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.||percentage of hemoglobin A1c||Standard Error|Least Squares Mean
792932|NCT00900146|Primary|Number of Participants With Adverse Events (AEs), Serious Adverse Events, Death and Clinical Significant AEs During 4 Months (Period II)|Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.|4 months (Period II)|The safety set (SAF) included all patients who received at least one dose of study medication during Period II.||Participants|||Number
792933|NCT00900159|Secondary|Sleep-dependent Memory Consolidation|A computer-based Word-pair tasks is the number of words recalled after sleep from a list of words shown prior to going to sleep.|On each treatment, after an 8.5 hour daytime sleep period following at least 3 consecutive night shifts|||words||Standard Deviation|Mean
792934|NCT00900159|Secondary|Objective Vigilance Task Performance|A computer-based Flanker Task elicits responses to an incongruent pairing of stimuli measured as reaction time, in milliseconds. The Flanker task tests response inhibition, or the participants suppression of an unwanted response. A target stimulus (symbol) is “flanked” by non-target stimuli (symbols) that are the same as the target stimulus, opposite of the target stimulus, or neutral with respect to the target stimulus. The task is intended to assess the ability to maintain “selective attention” in the presence of distractors.|On each treatment, after an 8.5 hour daytime sleep period following at least 3 consecutive night shifts|||milliseconds||Standard Deviation|Mean
792935|NCT00900159|Secondary|Subjective Sleepiness and Performance|The Karolinska Sleepiness Scale (KSS), a nine point Visual Analog Scale of alertness/sleepiness, was used to assess subjective sleepiness. The KSS is a scale from 1 to 9, from minimum to maximum sleepiness.|On each treatment, after an 8.5-hr daytime sleep episode following at least 3 consecutive night shifts|||units on a scale||Standard Error|Mean
792937|NCT00900159|Primary|Nighttime Wakefulness Assessed by Mean Sleep Latency Across 4 Maintenance of Wakefulness Tests|Participants underwent four Maintenance of Wakefulness Tests (MWT) at 2-hour intervals during the simulated night shift starting 5 hours after wake time. MWT range from 0 to 40 minutes, where shorter times to fall asleep represent greater sleepiness (worse). MWT tests are averaged, for a mean in minutes.|On each treatment, after an 8.5 hour daytime sleep period following at least 3 consecutive night shifts|||minutes||95% Confidence Interval|Mean
792938|NCT00900237|Primary|AUC0-t AUC From Time Zero to the Last Sampling Time|AUC0-t - area under the concentration versus time curve (AUC) from time zero to the last sampling time at which concentrations were at or above the limit of quantification CSF - cerebrospinal fluid Oxcarbazepine, BIA 2-194 and BIA 2-195 are active metabolites of Eslicarbazepine Acetate.|Day 9 - Pre-dose; 0.5h; 1h; 1.5h; 2h; 3h; 4h; 6h; 8h; 12h; 16h; 24h|||ng.h/mL||Standard Deviation|Mean
792939|NCT00900237|Primary|Cmax - Maximum Plasma Concentration in Plasma and Cerebral Spinal Fluid|Cmax - Maximum plasma concentration CSF - Cerebral Spinal Fluid Oxcarbazepine, BIA 2-194 and BIA 2-195 are active metabolites of Eslicarbazepine Acetate.|Day 9 - Pre-dose; 0.5h; 1h; 1.5h; 2h; 3h; 4h; 6h; 8h; 12h; 16h; 24h|||ng/mL||Standard Deviation|Mean
792940|NCT00900627|Secondary|Phase II: The Overall Survival (OS) Was Compared in Patients Treated With AZD8931 in Combination With Weekly Paclitaxel Versus Weekly Paclitaxel Alone|The time from the date of randomization until the date of death due to any cause.|Weekly visits for routine safety monitoring, accessed up to data cut off on 11th April 2012|Full Analysis Set||Months|Participants|Inter-Quartile Range|Median
792941|NCT00900627|Secondary|Phase II: Objective Tumour Response Rate (ORR) Was Compared in Patients Treated With AZD8931 in Combination With Weekly Paclitaxel Versus Weekly Paclitaxel Alone|The number of subjects with at least one visit response of CR or PR (Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive disease (PD), A ≥ 20% increase in the sum of diameters of target lesions and an absolute increase of ≥ 5mm; Stable disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Not Evaluable (NE), All target lesion measurements are missing or >1/3 target lesion measurements are missing and sum of diameters of non-missing target lesions does not qualify for PD; Not applicable (NA), No target lesions are recorded at baseline))|Baseline and every 8 weeks, accessed up to data cut off on 11th April 2012|Evaluable for response set (EFR set is all FAS patients with measureable disease at baseline)||Participants|||Number
792942|NCT00900627|Primary|Phase II: Progression-free-survival (PFS) Were Analyzed in Patients Treated With AZD8931 in Combination With Weekly Paclitaxel Versus Weekly Paclitaxel Alone|Time from the date of randomization until the date of objective disease progression (as per RECIST 1.1) or the date of death (by any cause in the absence of progression)|Baseline and every 8 weeks, accessed up to data cut off on 11th April 2012|Full Analysis Set||Months|Participants|Inter-Quartile Range|Median
792943|NCT00900627|Primary|Phase I: The Number of Dose Limiting Toxicities in AZD8931 in Combination With Weekly Paclitaxel|DLT is an AE or laboratory abnormality related to AZD8931, starting during the DLT evaluation period and meeting any of the following criteria (further detail in protocol): Symptomatic ocular surface lesion; CTCAE grade 4 haematological AE; CTCAE grade ≥3 of febrile neutropenia / neutropenia / thrombocytopenia / hyperkalaemia / hyperglycaemia / hypotension / urological toxicity / ILD / pneumonitis; QTcF interval > 500 msec, two ECGs ≥ 30 minutes apart; Symptomatic congestive cardiac failure and a drop in LVEF; Decrease in LVEF of ≥20% to below the LLN; CS rash remaining CTCAE grade ≥3 for ≥5 days despite optimal treatment; CTCAE grade ≥3 nausea, vomiting or diarrhoea, despite optimal therapy; Other CTCAE grade ≥3 toxicity which, in the opinion of the investigator, is CS and related to AZD8931; Delay to the administration of paclitaxel on D1 of Cycle 2 by ≥7 days. Patients could have more than one DLT.|Weekly visits for routine safety monitoring from Day 1 to Day 28 for each participant|Safety population (all participants who received at least one dose)||Number of Dose Limiting Toxicities|||Number
792944|NCT00900666|Secondary|Gait Function (Based on 6-Minute Walk)|Average walking speed as calculated during a 6-min walk|baseline, 1-mo and 4-mo post-injection|intention to treat||meters/sec||Standard Deviation|Mean
792945|NCT00900666|Primary|Mean Peak Knee Flexion During Swing Phase of Gait|Measured via computerized gait analysis, the average of peak knee flexion during swing phase.|baseline, 1-month and 4-month post-injection|||degrees||Standard Deviation|Mean
792946|NCT00900731|Secondary|Percentage of Days With no Rescue Medication Use During the 12 Weeks of Treatment|A day with no rescue medication was defined as any day in the diary that the participant used no puffs of rescue medication. The percentage of days with no rescue medication was calculated by dividing the number of days with no rescue medication over the 12 week treatment period by the number of evaluable days and multiplying by 100. Mixed model used baseline percentage of days with no rescue medication, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.|Up to 12 weeks|Full analysis set included all participants who received at least one dose of study medication. The endpoint was analyzed only for those participants who had data for this outcome measure.||Percentage of days||Standard Error|Least Squares Mean
792947|NCT00900731|Secondary|Change From Baseline in the Mean Number Per Day of Nighttime Puffs of Rescue Medication Over the Study Duration (From Day 1 to Week 12)|Participants recorded the number of puffs of rescue medication taken in the previous 12 hours each morning in an electronic diary. The number of nighttime puffs per day over the 12 weeks of treatment was divided by the number of days to derive the mean number per day of nighttime puffs of rescue medication for each participant. Mixed model used baseline number of nighttime puffs per day of rescue medication, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.|Baseline, up to 12 weeks|Full analysis set included all participants who received at least 1 dose of study medication. The endpoint was analyzed only for those participants who had data at baseline and at week 12 for this outcome measure.||Puffs||Standard Error|Least Squares Mean
793001|NCT00901628|Secondary|Participant Number of Postoperative Nausea and Vomiting During 24 Hours After Surgery|An independent investigator assessed participant number of postoperative nausea and vomiting during 24 hours after surgery. Nausea was defined as a subjective unpleasant sensation associated with awareness of the urge to vomit; and vomiting, as the forceful expulsion of gastric contents from the mouth.|24 hours after surgery|||participants|||Number
792948|NCT00900731|Secondary|Change From Baseline in the Mean Number Per Day of Daytime Puffs of Rescue Medication Over the Study Duration (From Day 1 to Week 12)|Participants recorded the number of puffs of rescue medication taken in the previous 12 hours each evening in an electronic diary. The number of daytime puffs per day over the 12 weeks of treatment was divided by the number of days to derive the mean number per day of daytime puffs of rescue medication for each participant. Mixed model used baseline number of daytime puffs per day of rescue medication, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.|Baseline, up to 12 weeks|Full analysis set included all participants who received at least 1 dose of study medication. The endpoint was analyzed only for those participants who had data at baseline and at week 12 for this outcome measure.||Puffs||Standard Error|Least Squares Mean
792949|NCT00900731|Secondary|Change From Baseline in the Mean Number of Puffs Per Day of Rescue Medication Over the Study Duration (From Day 1 to Week 12)|Participants recorded the number of puffs of rescue medication taken in the previous 12 hours each morning and evening in an electronic diary. The number of puffs per day over the 12 weeks of treatment was divided by the number of days to derive the mean number per day of puffs of rescue medication for each participant. Mixed model used baseline number of puffs per day of rescue medication, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.|Baseline, up to 12 weeks|Full analysis set included all participants who received at least 1 dose of study medication. The endpoint was analyzed only for those participants who had data at baseline and at week 12 for this outcome measure.||Puffs||Standard Error|Least Squares Mean
792950|NCT00900731|Secondary|Quality of Life Assessment With St. George's Respiratory Questionnaire (SGRQ) Total Score After 12 Weeks of Treatment|SGRQ is a health related quality of life questionnaire consisting of 50 items in three domains: symptoms (frequency and severity), activity (that cause or are limited by breathlessness) and impacts (social functioning & psychological disturbances resulting from airway disease). The total score is 0 to 100 with a higher score indicating greater impairment of health status. Mixed model used baseline SGRQ, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.|12 weeks|Full Analysis Set included all randomized participants who received at least one dose of study drug. The endpoint was analyzed only for those participants who had data at week 12 for this outcome measure. Missing data were imputed using Last Observation Carried Forward.||Score on a scale||Standard Error|Least Squares Mean
792951|NCT00900731|Secondary|Transition Dyspnea Index (TDI) Focal Score After 12 Weeks of Treatment|TDI focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort. Each domain is scored from -3 (major deterioration) to 3 (major improvement) to give an overall TDI focal score of -9 to 9 with a negative score indicating a deterioration from baseline. A 1 unit difference in the TDI focal score is clinically significant. Mixed model used baseline dyspnea index, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.|12 weeks|Full Analysis Set included all randomized participants who received at least one dose of study drug. The endpoint was analyzed only for those participants who had data at week 12 for this outcome measure. Missing data were imputed using Last Observation Carried Forward.||Score on a scale||Standard Error|Least Squares Mean
792952|NCT00900731|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose at the End of Treatment (Week 12)|Spirometry was conducted according to internationally accepted standards. FEV1 was measured at 5 and 30 minutes; and 1, 2, and 4 hours post-dose on Week 12. Standardized FEV1 AUC (5 minutes-4 hour) post-dose at week 12 was calculated based on the trapezoidal rule, and was adjusted for the area per time unit by using the scheduled time of measurements for FEV1. Mixed model used baseline FEV1, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.|5 minutes to 4 hours post-dose at the end of treatment (week 12)|Full analysis set included all participants who received at least one dose of study medication. The endpoint was analyzed only for those participants who had data at week 12 for this outcome measure.||Liter||Standard Error|Least Squares Mean
792953|NCT00900731|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) at End of Treatment (Week 12)|Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 hour 10 minute and 23 hour 45 minute post-dose FEV1 readings. Mixed model used baseline FEV1, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.|End of treatment (Week 12)|Per-protocol population included all participants who received at least one dose of study medication without any major protocol deviations. The endpoint was analyzed only for those participants who had data for this outcome measure. Missing data were imputed using last observation carried forward.||Liters||Standard Error|Least Squares Mean
792954|NCT00900757|Secondary|Percentage of Participants With a Osoba Vomiting/Retching Module Maximum Standardized Score of Zero for Each Week of Radiation (XRT) and Temozolomide (TMZ)|Percentage of participants with a Osoba vomiting/retching module maximum standardized score of zero for each week of radiation (XRT) and Temozolomide (TMZ). The Osoba vomiting/retching module is a 5-item questionnaire assessing the effect of vomiting/retching on quality of life and daily functioning. Raw scores range from 5-20 and have been converted to standardized scores (0-100) using the formula: std_score = round((raw_score - 5) * 6.66). Lower scores indicate better quality fo life. The maximum standardized score of all vomiting/retching scores collected during the week (days 1, 3 and 6) was used for this outcome.|6 weeks|||percentage of participants|||Number
792955|NCT00900757|Secondary|Percentage of Participants With a Osoba Nausea Module Maximum Standardized Score of Zero for Each Week of Radiation (XRT) and Temozolomide (TMZ)|Percentage of participants with a Osoba nausea module maximum standardized score of zero for each week of radiation (XRT) and Temozolomide (TMZ). The Osoba nausea module is a 5-item questionnaire assessing the effect of nausea on quality of life and daily functioning. Raw scores range from 5-20 and have been converted to standardized scores (0-100) using the formula: std_score = round((raw_score - 5) * 6.66). Lower scores indicate better quality fo life. The maximum standardized score of all nausea scores collected during the week (days 1, 3 and 6) was used for this outcome.|6 weeks|||percentage of participants|||Number
792956|NCT00900757|Secondary|Change in the Functional Living Index - Emesis (FLIE) Score From Baseline to Each Week of Radiation (XRT) and Temozolomide (TMZ) Treatment|The FLIE is a 18-item validated questionnaire for assessing the effects of chemotherapy-induced nausea and emesis on quality of life and daily functioning. The raw score range is 18-126 with higher scores indicating better quality of life. For each week of XRT and TMZ, the change from baseline was calculated by subtracting the baseline score from the mean of the day 1, 3 and 6 scores. A negative change represents worsening in quality of life due to nausea and emesis.|6 weeks|||units on a scale||95% Confidence Interval|Mean
792957|NCT00900757|Secondary|Complete Response|The percentage of participants with a complete response defined as no emetic episode or use of rescue medication while receiving radiation (XRT) and concomitant temozolomide (TMZ).|6 weeks|||percentage of participants||95% Confidence Interval|Number
792958|NCT00900757|Primary|Safety and Tolerability of Palonosetron as Determined by the Number of Participants Who Experience Unacceptable Toxicity|The number of participants with unacceptable toxicity defined as ≥grade 3, non-hematologic toxicities that are possibly, probably or definitely related to the study regimen.|6 weeks|||participants|||Number
792959|NCT00900796|Secondary|Percentage of Participants With ASAS 40 Response Who Started Second Anti-TNF Treatment and Were Treated for at Least 16 Weeks|ASAS measures symptomatic improvement in ankylosing spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40% improvement from baseline and an absolute change of greater than or equal to (>=) 2 units on a 0-10 scale (0=no disease activity, 10=high disease activity) for >= 3 domains, and no worsening in remaining domain.|Week 32|Analysis population included all participants with an inadequate response, 16 weeks after starting the first anti-TNF treatment as determined by ASAS 40 and who received second anti-TNF treatment for at least 16 weeks (Phase 2).||percentage of participants|||Number
792960|NCT00900796|Secondary|Percentage of Participants Who Switched to Another Anti-TNF Treatment Due to Lack of Efficacy||Week 16|Analysis population included all participants enrolled in the study who gave their consent, satisfied all evaluation criteria and had information available at Week 16 after starting the first anti-TNF treatment (Phase 1). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||percentage of participants||95% Confidence Interval|Number
792961|NCT00900796|Secondary|Percentage of Participants With Assessment in Ankylosing Spondylitis (ASAS) 40 Response at Week 16|ASAS measures symptomatic improvement in ankylosing spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40 percent (%) improvement from baseline and an absolute change of greater than or equal to (>=) 2 units on a 0-10 scale (0=no disease activity, 10=high disease activity) for >= 3 domains, and no worsening in remaining domain.|Week 16|Analysis population included all participants enrolled in the study who gave their consent, satisfied all evaluation criteria and had information available at Week 16 after starting the first anti-TNF treatment (Phase 1).||percentage of participants||95% Confidence Interval|Number
792962|NCT00900796|Secondary|Percentage of Participants With Low Probability of Response and a Clinical Response at Week 16|Low probability of response = participants who met no more than 2 of 5 criteria at time of treatment start: CRP > 15 mg/L; time from onset of disease less than < 10 years; total spinal pain > 30 mm, measured as mean score on 100 mm VNS (higher score=more severe pain) for nocturnal and total spinal pain; BASDAI > 4 cm, measured as mean score on 10 cm VNS (higher score=more severe state) for discomfort, pain and fatigue; BASFI < 4.5 cm; measured as mean score on 10 cm VNS (higher score=less functionality) evaluating functional capacity. Assessment of response was as per investigator’s criteria.|Week 16|Analysis population included all participants enrolled in study who gave their consent, satisfied all evaluation criteria and had information available at Week 16 after starting first anti-TNF treatment (Phase 1). N (number of participants analyzed) signifies those participants who had low probability of response and were evaluable for the measure.||percentage of participants||95% Confidence Interval|Number
792963|NCT00900796|Secondary|Percentage of Participants With Low Probability of Response and no Response Who Received Second Anti-TNF Treatment|Low probability of response = participants who met no more than 2 of 5 criteria at time of treatment start: CRP > 15 mg/L; time from onset of disease less than < 10 years; total spinal pain > 30 mm, measured as mean score on 100 mm VNS (higher score=more severe pain) for nocturnal and total spinal pain; BASDAI > 4 cm, measured as mean score on 10 cm VNS (higher score=more severe state) for discomfort, pain and fatigue; BASFI < 4.5 cm; measured as mean score on 10 cm VNS (higher score=less functionality) evaluating functional capacity. Assessment of response was as per investigator’s criteria.|Week 32|Data was not analyzed as no participant met the criteria for low probability of response in phase 2 of the study.||percentage of participants||95% Confidence Interval|Number
792964|NCT00900796|Secondary|Percentage of Participants With High Probability of Response and no Response Who Received Second Anti-TNF Treatment|High probability of response=participants who met at least 3 of 5 criteria at start of treatment:C-reactive Protein (CRP) >15 mg/Liter (mg/L);time from onset of disease <10 years;total spinal pain >30 millimeter (mm), mean score on 100 mm visual numeric scale (VNS) for nocturnal, total spinal pain;Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) >4 centimeter (cm), mean score on 10 cm VNS for discomfort, pain, fatigue;Bath Ankylosing Spondylitis Functional index (BASFI) <4.5 cm, mean score on 10 cm VNS evaluating functional capacity. Assessment of response was per investigator.|Week 32|Analysis population included all participants with an inadequate response, 16 weeks after starting the first anti-TNF treatment as determined by the investigator and who received second anti-TNF treatment for at least 16 weeks (Phase 2).||percentage of participants||95% Confidence Interval|Number
792965|NCT00900796|Primary|Percentage of Participants With a Clinical Response|Assessment of clinical response was as per investigator’s discretion. Investigators were provided with the final consensus document of the Spanish Society for Rheumatology (SER) for the biological treatment of spondyloarthropathies as a guide for defining active AS, the indication of treatment with biological therapy and the assessment of response to it.|Week 16|Analysis population included all participants enrolled in the study who gave their consent, satisfied all evaluation criteria and had information available at Week 16 after starting the first anti-TNF treatment (Phase 1).||percentage of participants||95% Confidence Interval|Number
793002|NCT00901628|Secondary|Intravenous Patient Controlled Analgesia(PCA) Consumption During 24 Hours After Surgery|Fentanyl based PCA consumption via PCA pump (microgram)|24 hours postoperative|||microgram||Standard Deviation|Mean
792966|NCT00900822|Secondary|Implant Success Rate|Implant success is defined as the absence of any continuous peri-implant radiolucency based on radiographic findings, absence of implant mobility, absence of a recurrent per-implant infection with suppuration (where an infection is termed recurrent if it is observed at two or more 3-month follow-up visits after treatment with systemic antibiotics), and bone level changes around the implant less than 1 mm during the first year of loading and less than 0.2 mm per year thereafter.|12 months after loading the implant|||percentage of implants|||Number
792967|NCT00900822|Primary|Histologically Measured Bone to Implant Contact (BIC)|Results from morphometric measurements of percentage of new bone in contact with the total surface of the titanium implant, area of new bone and bone graft particles in contact with bone|9 months after implant placement|This was a split-mouth design. Each patient received both treatments. There was one sample in the Straumann BoneCeramic group that could not be analyzed.||percentage of total surface||Standard Deviation|Mean
792968|NCT00900822|Secondary|Implant Survival Rate|The percentage of implants remaining in the jaw.|12 months after loading the implant|||percentage of implants|||Number
792969|NCT00901017|Secondary|Implant Survival Rate|"A surviving implant will be considered an implant fulfilling the following criteria:
Absence of any continuous peri-implant radiolucency based on radiographic findings.
Absence of implant mobility.
Absence of a recurrent peri-implant infection with suppuration (where an infection is termed recurrent if it is observed at two or more follow-up visits after treatment with systemic antibiotics).
Absence of pain or any other adverse observation by the patient, so that the implant has to be removed."|12 months|||% of implants|||Number
792970|NCT00901017|Secondary|Implant Success Rate|"The success of oral implant will be determined according to the following parameters:
Absence of any continuous peri-implant radiolucency based on radiographic findings.
Absence of implant mobility (based on hand testing)
Absence of a peri-implant infection with suppuration.
Absence of a recurrent peri-implant infection with suppuration (where an infection is termed recurrent if it is observed at two or more follow-up visits after treatment with systemic antibiotics).
Bone level changes evaluated on periapical radiographs around implants less than 1 mm during the first year of loading, starting at abutment connection."|12 months|||% of implants|||Number
792971|NCT00901017|Secondary|Implant Survival Rate|"A surviving implant will be considered an implant fulfilling the following criteria:
Absence of any continuous peri-implant radiolucency based on radiographic findings.
Absence of implant mobility.
Absence of a recurrent peri-implant infection with suppuration (where an infection is termed recurrent if it is observed at two or more follow-up visits after treatment with systemic antibiotics).
Absence of pain or any other adverse observation by the patient, so that the implant has to be removed."|6 Months|||% of implants|||Number
792972|NCT00901017|Secondary|Implant Success Rate|"The success of oral implant will be determined according to the following parameters:
Absence of any continuous peri-implant radiolucency based on radiographic findings.
Absence of implant mobility (based on hand testing)
Absence of a peri-implant infection with suppuration.
Absence of a recurrent peri-implant infection with suppuration (where an infection is termed recurrent if it is observed at two or more follow-up visits after treatment with systemic antibiotics).
Bone level changes evaluated on periapical radiographs around implants less than 1 mm during the first year of loading, starting at abutment connection."|6 months|||% of implants|||Number
792973|NCT00901017|Primary|Change of Vertical Height of Buccal Defects|Change of vertical height of buccal defects over 26 weeks, measured during 1st - and 2nd- stage surgery|Baseline to 26 weeks|14 patients represented the ITT population.||mm||95% Confidence Interval|Mean
792974|NCT00901186|Secondary|Percentage of CRT Change From Baseline by Study Visit|CRT was assessed by Optical Coherence Tomography (OCT).|Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12|ITT: The ITT consisted of all randomized participants who received at least one intravitreal ranibizumab injection of one laser photocoagulation treatment for whom there was at least one baseline and one post-treatment BCVA value. For each month, participants who had both the baseline and the study month CRT values were included in the analysis.||Percentage change||Standard Deviation|Mean
792975|NCT00901186|Secondary|Mean Change From Baseline in Central Retinal Thickness (CRT) by Study Visit|CRT was assessed by Optical Coherence Tomography (OCT).|Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12|ITT: The ITT consisted of all randomized participants who received at least one intravitreal ranibizumab injection of one laser photocoagulation treatment for whom there was at least one baseline and one post-treatment BCVA value. For each month, participants who had both the baseline and the study month CRT values were included in the analysis.||micrometers||Standard Deviation|Mean
792976|NCT00901186|Secondary|Percentage of Participants With VA > 73 Letters With Ranibizumab (0.5 mg) vs Laser.|VA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters.|12 months|Intent-to-treat (ITT): The ITT consisted of all randomized participants who received at least one intravitreal ranibizumab injection of one laser photocoagulation treatment for whom there was at least one baseline and one post-treatment BCVA value.||Percentage of participants|||Number
792977|NCT00901186|Secondary|Evolution of Mean Change From Baseline in BCVA by Study Visit|Visual acuity (VA) was assessed on the study eye during every study visit using best correction determined from protocol refraction. VA measurements were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters.|Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12|ITT: The ITT consisted of all randomized participants who received at least one intravitreal ranibizumab injection of one laser photocoagulation treatment for whom there was at least one baseline and one post-treatment BCVA value. For each month, participants who had both the baseline and the study month BCVA values were included in the analysis.||letters||Standard Deviation|Mean
792978|NCT00901186|Secondary|Percentage of Participants With Improvement in BCVA|Visual acuity (VA) was assessed on the study eye during every study visit using best correction determined from protocol refraction. VA measurements were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters.|12 months|Intent-to-treat (ITT): The ITT consisted of all randomized participants who received at least one intravitreal ranibizumab injection of one laser photocoagulation treatment for whom there was at least one baseline and one post-treatment BCVA value.||Percentage of participants|||Number
792979|NCT00901186|Primary|Mean Change From Baseline in Best Corrected Visual Acuity (BCVA)|Visual acuity (VA) was assessed on the study eye during every study visit using best correction determined from protocol refraction. VA measurements were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters.|Baseline, 12 months|Intent-to-treat (ITT): The ITT consisted of all randomized participants who received at least one intravitreal ranibizumab injection of one laser photocoagulation treatment for whom there was at least one baseline and one post-treatment BCVA value. Participants who had both Baseline and Month 12 BCVA values only were included in this analysis.||letters||Standard Deviation|Mean
792980|NCT00901225|Secondary|Platelet Engraftment|Days to platelet count >20,000|12 months|||days||Full Range|Median
792981|NCT00901225|Secondary|Number of Subjects Experiencing Durability of Engraftment|Durability of engraftment is defined as the duration and stability of hematopoiesis following autologous transplantation. Subjects who experience durable engraftment have neutrophil counts greater than 500 and platelet counts greater than 20,000 within the specified time frame.|12 months|||participants|||Number
792982|NCT00901225|Secondary|Days to Absolute Neutrophil Count >500||12 months|||days||Full Range|Median
792983|NCT00901225|Secondary|Number of Subjects Experiencing Graft Failure|To investigate the hematological activity of Plerixafor as measured by Graft Failure. Graft failure is defined as failure of initial engraftment (primary graft failure) or initial engraftment, but subsequent loss of hematopoiesis (secondary graft failure).|12 months|||participants|||Number
792984|NCT00901225|Secondary|Number of Participants Experiencing a Grade III/IV Toxicity|Safety of plerixafor as measured by Grade III/IV Toxicity|6 months post transplant or until relapse|||participants|||Number
792985|NCT00901225|Primary|Number of Participants Who Achieved > or Equal to 2 X 10(6)CD34+ Cells/kg Within 3 Days of Apheresis After Receiving Plerixafor With G-CSF.||5 days after receiving G-CSF|||participants|||Number
792986|NCT00901316|Primary|Medically Attended Skin and Soft Tissue Infections (MA-SSI)|Medically attended skin and soft tissue infections (MA-SSI) which is defined as a skin or soft tissue infection that has been evaluated and treated by a medical professional in an office, clinic, urgent care or emergency center setting.|From time of enrollment until the first MA-SSI or 12 months following enrollment, whichever came first.|||percentage of partipants||95% Confidence Interval|Number
792987|NCT00901342|Primary|Number of Participants Who Received At Least 1 Infusion of Sipuleucel-T in Men With Metastatic Castrate-resistant Prostate Cancer (CRPC)||Day 0 (first infusion) and up to 3 infusions at 2-week intervals|Participants who Received At least 1 Infusion||participants|||Number
792988|NCT00901459|Secondary|Change in Craving for Cigarettes After Controlled Smoke Presentations.|Craving reduction was assessed orally by an item on the cigarette evaluation questionnaire (“Did it immediately reduce your craving for cigarettes?”) after smoking presentations through the controlled puff volume apparatus.|After smoking a cigarette through the controlled puff volume apparatus during rTMS|||units on a scale||Standard Deviation|Mean
792989|NCT00901459|Primary|Change in Craving for Cigarettes After Smoking Cues Versus Neutral Cues Using a Repeated Measure Design.|Cigarette craving was assessed orally during each rTMS Session, before and after each stimulus presentation and cigarette smoking with a brief version of the Shiffman-Jarvik questionnaire (14), which contained items assessing cigarette craving using the following subscale: CRAVING (“urges to smoke,” “miss a cigarette,” and “crave cigarettes”), MOOD (“calm,” “tense,” and “irritable”), AROUSAL (“wide awake,” “able to concentrate”), and HUNGER (“feel hungry”). The scale for the Shiffman-Jarvik questionnaire is a Likert item scale with measurements 1-Not at All; 2-Very Little; 3-A Little; 4-Moderately; 5- A Lot; 6-Quite A Lot and 7-Extremely. The change in craving for cigarettes after smoking cues versus neutral cues using the parenthetical items listed above with the subscale CRAVING were used to determine the primary outcome. A negative value represents a decrease in reported cigarette craving.|Following exposure to in vivo cues|A repeated measures design exposed participants to three different rTMS conditions over 3 separate visits, with order counterbalanced using latin square design.||units on a scale||Standard Error|Mean
792990|NCT00901576|Primary|T 1/2 of d-Methylphenidate||0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose|PKP||hours||Standard Deviation|Mean
792991|NCT00901576|Primary|Tmax of d-Methylphenidate||0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose|PKP||hours||Standard Deviation|Mean
792992|NCT00901576|Primary|AUC of d-Methylphenidate||0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose|PKP||ng*h/ml||Standard Deviation|Mean
792993|NCT00901576|Primary|Cmax of d-Methylphenidate||0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose|PKP||ng/ml||Standard Deviation|Mean
792994|NCT00901576|Primary|Time of Plasma Half-Life(T 1/2) of Guanfacine||0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose|PKP||hours||Standard Deviation|Mean
792995|NCT00901576|Primary|Time of Maximum Plasma Concentration (Tmax) of Guanfacine||0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose|PKP||hours||Standard Deviation|Mean
792996|NCT00901576|Primary|Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Guanfacine||0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose|PKP||ng*h/ml||Standard Deviation|Mean
792997|NCT00901576|Primary|Maximum Plasma Concentration (Cmax) of Guanfacine||0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose|Pharmacokinetic Population (PKP) consists of all subjects in the Safety Population who had evaluable concentration-time profiles for guanfacine or d-methylphenidate. The Safety Population consists of all subjects who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.||ng/ml||Standard Deviation|Mean
792998|NCT00901628|Secondary|Maximal Flexion Angle Degree on Postoperative 7 Day|An independent investigator measured the maximal flexion angle (degree) of replaced knee with 28 centimeter armed goniometer on postoperative 7 day|postoperative 7 day|||degree||Standard Deviation|Mean
792999|NCT00901628|Secondary|The Proportion of Patients Who Could Raise Leg With Replaced Knee Extended||24 hours postoperative|||participants|||Number
793000|NCT00901628|Secondary|the Proportion of Patients Who Were Satisfied With the Pain Management||postoperative 7 day|||participants|||Number
793003|NCT00901628|Primary|Pain( Visual Analog Scale )|An independent investigator who was blinded to randomization assessed pain level using 0 to 10 visual analog scale (VAS) that ranged from 0 (no pain) to 10 (worst imaginable pain)at the night after operation.|the night after surgery|||units on a scale||Standard Deviation|Mean
793004|NCT00901901|Other Pre-specified|Tumor Response|Tumor response was the proportion of participants with the best tumor response (ie, achieving either a confirmed complete response [CR] or partial response [PR], according to Response Evaluation Criteria in Solid Tumors [RECIST] criteria).|From randomization of the first participant until 34 months later (cut-off date), assessed every 6 weeks|The full analysis set (FAS), which was defined as all randomized participants||Participants|||Number
793005|NCT00901901|Other Pre-specified|Time to Response|Time to response was the number of days from randomization to the date the CR or PR was documented (with confirmation) (Note: the relevant date is that of the first documentation, not the confirmation date).|From randomization of the first participant until 34 months later (cut-off date), assessed every 6 weeks|The full analysis set (FAS), which was defined as all randomized participants. Time to response was evaluated in the 14 participants in the sorafenib + placebo group and 24 participants in the sorafenib + erlotinib group who achieved their confirmed best response as CR or PR.||Days||95% Confidence Interval|Median
793006|NCT00901901|Other Pre-specified|Duration of Response|Duration of response - RECIST: number of days from the date that CR or PR is first documented to date that PD is first objectively documented or to death before progression. Note: the relevant date is that of the first documentation, not the confirmation date (if participant progressed or died then censored=no) or to last observation if participant did not progress or die then censored=yes note: this last observation date should be the same as that used for time to progression.|From randomization of the first participant until 34 months later (cut-off date), assessed every 6 weeks|The full analysis set (FAS), which was defined as all randomized participants. Duration of response was evaluated in the 14 participants in the sorafenib + placebo group and 24 participants in the sorafenib + erlotinib group who achieved their confirmed best response as CR or PR.||Days||95% Confidence Interval|Median
793007|NCT00901901|Secondary|Health-related Quality of Life and Utility Values as Measured by EQ-5D - VAS|Participants indicated on a scale of 0 (worst) to 100 (best) how good or bad their health state was on that particular day.|The EQ-5D VAS was administered at the beginning of the visit prior to seeing the investigator. Questionnaires were to be completed every 6 weeks (Day 1 of each cycle) for subsequent cycles and at the end of treatment visit.|The full analysis set (FAS), which was defined as all randomized participants||Scores on a scale||95% Confidence Interval|Least Squares Mean
793008|NCT00901901|Secondary|Health-related Quality of Life and Utility Values as Measured by EQ-5D - Index|The European quality of life scale (5 dimensions) (EQ-5D) questionnaire was given to the participants at each visit. The EQ-5D questionnaire consisted of 5 ordinal categorical responses (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). The scores for the EQ-5D dimensions are assigned according to the level of problems reported (1 ‘no problems’; 2 ‘some problems’; 3 ‘extreme problems’). The 5 health dimensions are summarized into a single score, the EQ-5D index score. The EQ-5D index score has a range of 0 and 1 with 0 representing death and 1 representing perfect health.|The EQ-5D was administered at the beginning of the visit prior to seeing the investigator. Questionnaires were to be completed every 6 weeks (Day 1 of each cycle) for subsequent cycles and at the end of treatment visit.|The full analysis set (FAS), which was defined as all randomized participants||Scores on a scale||95% Confidence Interval|Least Squares Mean
793009|NCT00901901|Secondary|Disease Control|Disease control was defined as the number of participants who had a best response rating of complet response (CR), partial response (PR), or stable disease (SD) according to RECIST assessed by magnetic resonance imaging (MRI) that was confirmed at least 28 days from the first demonstration of that rating. CR: disappearance of all clinical and radiological evidence of target and non-target tumors. PR: at least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD. SD: steady state of disease. Neither sufficient shrinkage for PR nor sufficient increase for PD.|From randomization of the first participant until 34 months later (cut-off date), assessed every 6 weeks|The full analysis set (FAS), which was defined as all randomized participants||Participants|||Number
793010|NCT00901901|Secondary|Time to Radiological Tumor Progression (TTP)|TTP was the time from randomization to radiological tumor progression. Participants without radiological tumor progression at the time of analysis were censored at their last date of tumor evaluation. Progressive disease (PD) was defined using Response Evaluation Criteria in Solid Tumors (RECIST version 1.0), as at least a 20% increase in the sum of longest diameter (LD) of measured lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions. Appearance of new lesions also constituted PD.|From randomization of the first participant until 34 months later (cut-off date), assessed every 6 weeks|The full analysis set (FAS), which was defined as all randomized participants||Days||95% Confidence Interval|Median
793011|NCT00901901|Primary|Overall Survival|Overall Survival (OS) was defined as the time from date of randomization to death due to any cause.|From randomization of the first patient until 34 months or date of death of any cause whichever came first|The full analysis set (FAS), which was defined as all randomized participants||Days||95% Confidence Interval|Median
793012|NCT00894504|Secondary|Correlation of Biomarker Expressions of EGFR, K-ras, p53, PTEN Expression, and PI3K in Triple-negative Breast Cancer With Response to Treatment With the Combination of Gemcitabine, Carboplatin, and Panitumumab|Median PFS (95% CI), months, reported by biomarker expression/mutation status for: EGFR, p53, PTEN, PIK3CA, KRAS|18 months|Excludes patients in the following categories due to insufficient data: PTEN status unknown, PIK3CA Status unknown and KRAS no mutation||months||95% Confidence Interval|Median
793013|NCT00894504|Secondary|Number of Treatment-related Toxicities Occurring in ≥10% of Patients as a Measure of Tolerability and Toxicity|Assessments made through analysis of treatment-related adverse events and serious adverse events|every 6 weeks until discontinuation of treatment, expected average of 18 months|||participants|||Number
793014|NCT00894504|Secondary|Objective Response Rate and Clinical Benefit Rate|Estimated as the proportion of subjects who meet the criteria for complete or partial response (CR or PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 - for target lesions assessed by MRI: Complete Response (CR) is defined as disappearance of all target lesions; Partial Response (PR) is defined as >=30% decrease in the sum of the longest diameter of target lesions.|every 6 weeks until treatment discontinuation|All evaluable patients per RECIST v 1.1||Participants|||Number
793052|NCT00894803|Post-Hoc|Death Within 90 Days of Treatment Onset|Death due to any cause within 90 days of treatment onset|Within 90 days of treatment onset|||participants|||Number
793015|NCT00894504|Primary|Progression-free Survival (PFS)|Measured from Day 1 of study drug administration to disease progression - defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as a 20% increase in the sum of the longest diameter of target lesions and/or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions|every 6 weeks until treatment discontinuation|||Months||95% Confidence Interval|Median
793016|NCT00894517|Secondary|Change From Baseline in Normal Sperm Morphology|Sperm Morphology was evaluated using the average of two semen samples collected 2 to 5 days apart at Baseline and at Week 12. Normal sperm morphology was assessed from slide smears sent to a central reading facility. A positive change from Baseline indicated improvement.|Baseline, Week 12|Safety population included all randomized participants who received treatment.||Percent||Standard Deviation|Mean
793017|NCT00894517|Secondary|Change From Baseline in Total Sperm Motility|Sperm motility was calculated using the average of two semen samples collected 2 to 5 days apart at Baseline and at Week 12. Sperm motility was assessed using the CELL-VU chamber and was scored according to the World Health Organization criteria for sperm progression and motility. A total of at least 200 motile and immotile sperm were counted. A percent was determined by the calculation of motile sperm/total sperm count. A negative change from Baseline indicated a worsening.|Baseline, Week 12|Safety population included all randomized participants who received treatment.||Percent||Standard Deviation|Mean
793018|NCT00894517|Secondary|Change From Baseline in Ejaculatory Volume|Ejaculatory volume was calculated using the average of two semen samples collected 2 to 5 days apart at Baseline and at Week 12. Ejaculatory volume was measured using a standard pipette (measuring device). A negative change from Baseline indicated worsening.|Baseline, Week 12|Safety population included all randomized participants who received treatment.||milliliters (mL)||Standard Deviation|Mean
793019|NCT00894517|Secondary|Change From Baseline in Log Transformed Sperm Concentration|Sperm concentration was calculated based on the average of two semen samples collected 2 to 5 days apart at Baseline and at Week 12. Collected sperm samples were assessed using a CELL-VU® count chamber. The total number of sperm per 100 boxes on the chamber grid were counted. Sperm Concentration = total number of sperm counted in 100 boxes × dilution factor / 1 × 10^6 and is reported in millions per milliliter. Log transformation of the sperm concentration was used for analysis . The log transformed sperm concentration data has no units. A negative change from Baseline indicated a lower sperm concentration (worsening).|Baseline, Week 12|Safety population included all randomized participants who received treatment.||Unitless||Standard Deviation|Mean
793020|NCT00894517|Primary|Percent Change in Total Sperm Count Per Ejaculate|Sperm count per ejaculate was calculated based on the average of two semen samples collected 2 to 5 days apart at Baseline and at Week 12. Ejaculatory volume and sperm concentration were used to determine the total sperm count per ejaculate. A positive percent change from Baseline indicated improvement.|Baseline, Week 12|Safety population included all randomized participants who received treatment.||Percent change||Standard Deviation|Mean
793021|NCT00894543|Secondary|Secondary Outcome: Change in Daily Hot Flash Bother Between Baseline and Week 8 as Recorded on Daily Diaries|Change in daily hot flash bother between baseline & week 8 was calculated as mean difference. Baseline daily bother was the mean of the highest daily ratings for two screening weeks pre-baseline. Week 8 bother was daily mean of the highest daily bother ratings during the week before week 8. Modified intention to treat analysis included all randomized participants who provided diary data, which were analyzed regardless of adherence to treatment assignment. Hot flash bother was rated as 1 (none), 2 (a little), 3 (moderately), 4 (a lot) as adopted from the Study of Women Across the Nation (SWAN).|week 8 minus baseline|"Twice daily rating for bother using response categories from the Study of Women Across the Nation (SWAN): 1 (not at all), 2 (very little), 3 (moderately), 4 (a lot).
Modified intention to treat analysis included all randomized participants who provided diary data, which were analyzed regardless of adherence to treatment assignment."||Scores on a scale||95% Confidence Interval|Mean
793022|NCT00894543|Primary|Change in Daily Severity of Hot Flashes Between Baseline and Week 8 as Assessed by Prospective Daily Diaries|Change in daily hot flash severity between baseline & week 8 was calculated as mean difference. Baseline severity ratings were calculated as daily mean ratings for the first two screening weeks pre-baseline. Week 8 severity ratings were calculated as daily mean ratings during the week before week 8. Modified intention to treat analysis included all randomized participants who provided diary data, which were analyzed regardless of adherence to treatment assignment. Hot flash severity was rated as 1 (mild), 2 (moderate), or 3 (severe) as adopted from the Study of Women Across the Nation (SWAN).|week 8 minus baseline|Hot flash severity was rated as 1 (mild), 2 (moderate), or 3 (severe) as adapted from the Study of Women Across the Nation (SWAN).||Scores on a scale||95% Confidence Interval|Mean
793023|NCT00894543|Primary|Change in Daily Severity of Hot Flashes Between Baseline and Week 4 as Assessed by Prospective Daily Diaries|"Change in daily hot flash severity from baseline to week 4 was calculated as the mean difference in hot flash severity ratings between baseline and week 4. Baseline was calculated as the daily mean from the first two weeks of hot flash severity ratings. Week 4 severity ratings were calculated as the daily mean from the ratings for the week prior to the week 4 visit.
Hot flash severity was rated as 1 (mild), 2 (moderate), or 3 (severe) as adopted from the Study of Women Across the Nation (SWAN)."|week 4 minus baseline|Hot flash severity was rated as 1 (mild), 2 (moderate), or 3 (severe) as adapted from the Study of Women Across the Nation (SWAN).||Scores on a scale||95% Confidence Interval|Mean
793024|NCT00894543|Secondary|Change in Daily Hot Flash Bother Between Baseline and Week 4 as Recorded on Daily Diaries|"Change in daily hot flash bother was calculated as the mean difference between baseline and week 4. Baseline was calculated as the daily mean of the highest daily bother ratings during the first two screening weeks. Week 4 was calculated as the daily mean of the highest of the daily bother ratings during the week prior to the week 4 visit.
Hot flash bother was rated as 1 (none), 2 (a little), 3 (moderately), or 4 (a lot) as adopted from the Study of Women Across the Nation (SWAN)."|week 4 minus baseline|Twice daily rating for bother using response categories from the Study of Women Across the Nation (SWAN): 1 (not at all), 2 (very little), 3 (moderately), 4 (a lot).||Scores on a scale||95% Confidence Interval|Mean
793053|NCT00894803|Other Pre-specified|Death Due to Stroke Within 7 Days of Treatment Onset|Death due to stroke within 7 days of treatment onset. Classified by blinded clinical investigators|Within 7 days of treatment onset|||participants|||Number
793054|NCT00894803|Other Pre-specified|Death Within 7 Days of Treatment Onset|Death due to any cause within 7 days of treatment onset|Within 7 days of treatment onset|||participants|||Number
793025|NCT00894543|Primary|Daily Severity of Hot Flashes Assessed by Prospective Daily Diaries|"Daily hot flash severity scores were calculated by by selecting the highest severity rating for hot flashes or night sweats for each woman in each 24-hour day. The score was set to missing on on any day data were missing or or hot flashes equaled 0. The daily mean of daily ratings for the first 2 screening weeks is reported.
Hot flash severity was rated as 1 (mild), 2 (moderate), or 3 (severe) as adopted from the Study of Women Across the Nation (SWAN)."|Baseline|Hot flash severity was rated as 1 (mild), 2 (moderate), or 3 (severe) as adapted from the Study of Women Across the Nation (SWAN).||Scores on a scale||95% Confidence Interval|Mean
793026|NCT00894543|Primary|Change in Daily Frequency of Hot Flashes Between Baseline and Week 8 as Assessed by Prospective Daily Diaries|Change in daily hot flash frequency was calculated as the daily mean difference between baseline and week 8. Baseline was calculated as the daily mean of the frequencies for the first two screening weeks. Week 8 was calculated as the daily mean of the daily frequencies during the week prior to the week 8 visit.|week 8 minus baseline|||Hot flashes/day||95% Confidence Interval|Mean
793027|NCT00894543|Primary|Change in Daily Frequency of Hot Flashes Between Baseline and Week 4 as Assessed by Prospective Daily Diaries|Change in daily hot flash frequency was calculated as the daily mean difference between baseline and week 4. Baseline was calculated as the daily mean of the daily frequencies for the first two screening weeks. Week 4 was calculated as the daily mean of the daily frequencies during the week prior to the week 4 visit.|week 4 minus baseline|||Hot flashes/day||95% Confidence Interval|Mean
793028|NCT00894543|Secondary|Daily Hot Flash Bother, Recorded on Daily Diaries|"Daily Hot flash bother scores were calculated by selecting the highest bother rating for hot flashes or night sweats for each woman in each 24-hour day. The score was set to missing on on any day data were missing or or hot flashes equaled 0. The daily mean of daily ratings for the first 2 screening weeks is reported.
Hot flash bother was rated as 1 (none), 2 (a little), 3 (moderately), or 4 (a lot) as adopted from the Study of Women Across the Nation (SWAN)."|Baseline|Twice daily rating for bother using response categories from the Study of Women Across the Nation (SWAN): 1 (not at all), 2 (very little), 3 (moderately), 4 (a lot).||Scores on a scale||95% Confidence Interval|Mean
793029|NCT00894543|Primary|Daily Frequency of Hot Flashes Per Day Assessed by Prospective Daily Diaries|Baseline hot flash frequency per day was calculated as the daily mean of the daily totals reported during the first two screening weeks.|Baseline|||Hot flashes/day||95% Confidence Interval|Mean
793030|NCT00894556|Secondary|Pain Freedom (PF)|Headache pain severity, relative to the administration of study medication, was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild pain), 2 (moderate pain), or 3 (severe pain). Pain freedom (PF) is defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 0 (no pain) post dose.|2 hours post dose|The FAS population included all randomized participants who had at least one evaluable attack. To be considered an evaluable attack the participant must have administered study treatment for this attack and must have had both a baseline severity measurement and at least one post-dose efficacy measurement prior to or including the 2-hour time point.||attacks|Evaluable Attacks||Number
793031|NCT00894556|Primary|Pain Relief (PR)|Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild pain), 2 (moderate pain), or 3 (severe pain). Pain relief (PR) is defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 1/0 post dose.|2 hours post dose|The FAS population included all randomized participants who had at least one evaluable attack. To be considered an evaluable attack the participant must have administered study treatment for this attack and must have had both a baseline severity measurement and at least one post-dose efficacy measurement prior to or including the 2-hour time point.||attacks|Evaluable Attacks||Number
793032|NCT00894647|Secondary|Number of Participants With Any Post-baseline Local Skin Reactions (LSRs)|"LSRs were assessed independently from AEs. The frequency and percentage of subjects, as well as the mean (SD) and median score for severity (none=0, mild=1, moderate=2, and severe=3), were summarized by treatment group and by visit for the following LSRs: erythema, edema, weeping/exudates, flaking/ scaling/dryness, and scabbing/crusting. Erosion and ulceration were also evaluated (none=0, erosion=1, and ulceration=2). A score of greater than 0 for the specified LSR was considered a treatment site reaction."|Weeks 2, 4, 6, 10, 14, 20, and 26|Safety population: all randomized subjects were presumed to have applied at least one application of study medication and were included in the safety population. This population was used for all safety analyses. Subjects were analyzed as treated.||participants|||Number
793033|NCT00894647|Secondary|Percent of Subjects With Complete Clearance|Proportion of subjects who achieved complete clearance of all AK lesions, cryosurgery-treated AK lesions, and non cryosurgery-treated AK lesions from baseline to Week 26/EOS in the ITT population.|Week 26|Intent to treat (ITT) population, last observation carried forward (LOCF)||percentage of participants||95% Confidence Interval|Number
793034|NCT00894647|Primary|Change From Baseline in Percentage of Lesion Count|The primary efficacy endpoint was a comparison between the active and placebo treatment groups of percent change from baseline in the total AK lesion count at Week 26. All AK lesions on the face were included in the analysis—treated and untreated AK lesions at baseline (defined as the AK lesion count just prior to cryosurgery) and new lesions that appeared post-baseline.|Week 26|Intent to treat population, Last Observation Carried Forward (LOCF)||percentage of lesion count||Standard Deviation|Mean
793035|NCT00894699|Primary|Summed Richmond Agitation Sedation Score (RASS) Over the 4-hour Study Period (SRS-4)|The primary efficacy endpoint of the study is the sedation level as assessed by the 10-point RASS, where unarousable is graded as minus 5 (- 5) and combative is graded as plus 4 (+ 4). The RASS was assessed at 15 time points throughout the four hour study period.|4 hour study period|ITT population were those patients that took at least one dose of study medication.||units on a scale||Standard Error|Least Squares Mean
793036|NCT00894790|Secondary|Change From Baseline in Participant's Responses to Neck Disability Index (NDI)|NDI: participant-administered 10-item questionnaire to assess how neck pain affects 10 activities of daily living (pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation) with six potential responses, each describing a greater degree of disability (0 = no disability to 5 = total disability). Total score calculated by adding individual item scores for evaluation scheme: 0-5 = No disability; 6-15 = Mild disability; 16-25 = Moderate disability; 26-35 = Severe disability; Above 35 = Complete disability.|Baseline, Days 7, 14|Data not analyzed due to study termination.||units on a scale||Standard Deviation|Mean
793037|NCT00894790|Secondary|Change From Baseline in Categorical Responses to Participant's Gastrointestinal (GI) Symptom Questionnaire|Two part questionnaire; First part assessed symptoms: feeling of gas/air in stomach or feeling bloated, nausea, vomiting, excessive burping or belching and worsening of heartburn or acid reflux. Participant rated Yes/No experienced, for how many days per week (1 through 7) for each symptom and how bothered they were (not at all, somewhat or very). Second part assessed the presence of general abdominal pain (steady, dull, sharp/shooting, always present or comes and goes), the number of days they experienced it (1 through 7) and how bothered they were by it (not at all, somewhat, very).|Baseline, Days 7, 14|Data not analyzed due to study termination.||units on a scale||Standard Deviation|Mean
793038|NCT00894790|Secondary|Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores|m-BPI-sf: participant rated 11-point Likert rating scale ranging from 0 (no pain) to 10 (worst pain possible). Pain severity index is the mean of item scores 2, 3, and 4 (pain right now, worst pain, and average pain level).|Baseline, Days 7, 14|Data not analyzed due to study termination.||units on a scale||Standard Deviation|Mean
793039|NCT00894790|Secondary|Change From Baseline in Modified Brief Pain Inventory-Short From (m-BPI-sf): Pain Interference Score|m-BPI-sf: participant-rated 11 point Likert rating scale ranging from 0 (does not interfere) to 10 (completely intereres) with functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours.|Baseline, Days 7, 14|Data not analyzed due to study termination.||units on a scale||Standard Deviation|Mean
793040|NCT00894790|Secondary|Change From Baseline on Physician’s Global Assessment of Cervical Injury|Physician rated responses evaluating the overall condition of participant's cervical injury at that time. Response option ranged from 1 (Very mild - Very mild signs and symptoms of cervical injury) to 5 (Very Severe - Very severe signs and symptoms of cervical injury).|Baseline, Days 7, 14|Data not analyzed due to study termination.||units on a scale||Standard Deviation|Mean
793041|NCT00894790|Secondary|Change From Baseline in Patient Global Assessment of Cervical Injury|Participant rated responses to question: Considering all the ways your cervical injury affects you, how are you doing today? Response options ranged from 1 (Very good - No symptoms and no limitation of normal activities) to 5 (Very Poor - Very severe symptoms which are intolerable and inability to carry out all normal activities).|Baseline, Days 7, 14|Data not analyzed due to study termination.||units on a scale||Standard Deviation|Mean
793042|NCT00894790|Secondary|Percentage of Participants With at Least a 20 mm Improvement on VAS-pain (Responder Rates)|Participant rated visual analogue scale (VAS) for pain ranging from 0 to 100 mm (no pain to worst possible pain) with at least a 20 mm improvement.|Baseline, Days 7, 14|Data not analyzed due to study termination.||Percentage of participants|||Number
793043|NCT00894790|Secondary|Change From Baseline on VAS-pain at Day 3 and Day 14|Participant rated visual analogue scale (VAS) for pain ranging from 0 to 100 mm (no pain to worst possible pain).|Baseline, Days 3, 14|Data not analyzed due to study termination.||mm||Standard Deviation|Mean
793044|NCT00894790|Primary|Change From Baseline to Day 7 of Participant's Assessment of Cervical Pain Due to Cervical Sprain|Participant rated visual analogue scale (VAS) for pain ranging from 0 to 100 mm (no pain to worst possible pain).|Baseline, Day 7|Data not analyzed due to study termination.||mm||Standard Deviation|Mean
793045|NCT00894803|Post-Hoc|Modified Rankin Scale (mRS) of 0-1|"Modified Rankin Scale of 0 or 1. The scale was performed by a study site investigator not directly involved with acute treatment of the patient. Study subjects dead at 90 days were given a value of ‘6’, and assigned the “bad” outcome. Also those lost to follow-up were assigned the “bad” outcome.
The Modified Rankin Score (mRS) is a 6 point ordinal scale, measuring functional status. 0 (no symptoms at all), 5 (severe disability; bedridden, incontinent, and requiring constant nursing care)."|90 days from treatment onset|||participants|||Number
793046|NCT00894803|Other Pre-specified|NIH Stroke Scale Score (NIHSS) ≤2 at 90 Days|"Study subjects with an NIH stroke scale score ≤ 2 points at 90 days from treatment onset compared to baseline value, those dead or unable to be evaluated by the NIHSS were assigned the “bad” outcome.
The NIH stroke scale score is scale based on 15 items individually scored between 0-2, 0-3 or 0-4 depending upon the item. The individual items are summed to produce a score between 0 and 42, where 0 indicates no deficit and 42 indicates death."|90 days from treatment onset|||participants|||Number
793047|NCT00894803|Other Pre-specified|NIH Stroke Scale Score (NIHSS) ≤ 2|"Study subjects with an NIH stroke scale score of ≤ 2 at 24 hours from treatment onset, those dead (n=1) or sedated and unable to be evaluated by the NIHSS were assigned the “bad” outcome (n=5).
The NIH stroke scale score is scale based on 15 items individually scored between 0-2, 0-3 or 0-4 depending upon the item. The individual items are summed to produce a score between 0 and 42, where 0 indicates no deficit and 42 indicates death."|Within 24 hours of treatment onset|||participants|||Number
793048|NCT00894803|Other Pre-specified|NIH Stroke Scale Score (NIHSS) ≤ 5|"Study subjects with an NIH stroke scale score of ≤ 5 at 2 hours from treatment onset, those sedated and unable to be evaluated by the NIHSS were assigned the “bad” outcome (n=1).
The NIH stroke scale score is scale based on 15 items individually scored between 0-2, 0-3 or 0-4 depending upon the item. The individual items are summed to produce a score between 0 and 42, where 0 indicates no deficit and 42 indicates death."|Within 2 hours of treatment onset|||participants|||Number
793049|NCT00894803|Secondary|Glasgow Outcome Scale (GOS) of 1|"Glasgow outcome scale score of 1 versus greater than 1. The scale was performed by a study site investigator not directly involved with acute treatment of the patient. Study subjects dead at 90 days and those lost to follow-up were assigned the “bad” outcome.
The Glasgow Outcome Scale is scored; 1=good recovery, 2=moderately disabled, 3=severely disabled, 4=vegetative survival, 5=dead."|90 days from treatment onset|||participants|||Number
793050|NCT00894803|Secondary|Barthel Index ≥ 95|"Barthel index score of ≥ 95. The scale was performed by a study site investigator not directly involved with acute treatment of the patient. Study subjects dead at 90 days and those lost to follow-up were assigned the “bad” outcome.
The Barthel index is a score comprised of 10 individual items. Each item may be scored 0, 5, 10 or 15; not all items use the full range of 4 possible values. The individual items are summed to produce a total score between 0 and 100; where 0 is inferior performance and 100 is optimal. A score of ≥ 95 is usually considered excellent."|90 days from treatment onset|||participants|||Number
793051|NCT00894803|Post-Hoc|Death Due to Stroke Within 90 Days of Treatment Onset|Death due to stroke within 90 days of treatment onset. Classified by blinded clinical investigators|Within 90 days of treatment onset|||participants|||Number
793055|NCT00894803|Other Pre-specified|Asymptomatic Intracranial Hemorrhage (asICH) Within 7 Days of Treatment Onset|Any ICH observed on CT by the study site neuroradiologist and the independent study neuroradiologist; the central reader. The ICH would not be related to a decline in neurologic status or the development of new neurologic symptoms which in the judgment of the clinical investigator was related to the ICH,where judgment of significant neurological decline was made by the local clinical investigator. A third independent reader will make the final determination if there is disagreement between the treating investigator and the central reader|Within 7 days of treatment onset|||participants|||Number
793056|NCT00894803|Other Pre-specified|Symptomatic Intracranial Hemorrhage (sICH) Within 7 Days of Treatment Onset|Any ICH related to a decline in neurologic status or the development of new neurologic symptoms which in the judgment of the clinical investigator was related to the ICH. Judgment of significant neurological decline was made by the local clinical investigator|Within 7 days of treatment onset|||participants|||Number
793057|NCT00894803|Other Pre-specified|Serious Systemic Bleeding|Incidence of serious systemic bleeding defined as requiring transfusion of 2 or more units of packed red blood cells.|Within 7 days of treatment onset|||participants|||Number
793058|NCT00894803|Primary|Modified Rankin Scale (mRS) Score <1 or Return to mRS Baseline|"Primary efficacy outcome measure - Modified Rankin Scale of 0 or 1 or return to the pre-stroke value at baseline or better. The scale was performed by a study site investigator not directly involved with acute treatment of the patient. Study subjects dead at 90 days were given a value of ‘6’, and assigned the “bad” outcome. Also those lost to follow-up were assigned the “bad” outcome.
The Modified Rankin Score (mRS) is a 6 point ordinal scale, measuring functional status. 0 (no symptoms at all), 5 (severe disability; bedridden, incontinent, and requiring constant nursing care)."|90 days from treatment onset|||participants|||Number
793059|NCT00894803|Primary|Symptomatic Intracranial Hemorrhage (sICH) Within 36 Hours of Treatment Onset|Primary safety outcome measure - Any ICH related to a decline in neurologic status or the development of new neurologic symptoms which in the judgment of the clinical investigator was related to the ICH. Judgment of significant neurological decline was made by the local clinical investigator|Within 36 hours of initiation of therapy|||participants|||Number
793060|NCT00894933|Primary|Safety - Bladder Neck Contracture|Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.|At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal|Subjects in whom device placement was attempted||Events|||Number
793061|NCT00894933|Primary|Safety - Separation/Disruption of the Anastomosis Requiring Corrective Intervention|Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.|At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal|Subjects in whom device placement was attempted||Events|||Number
793062|NCT00894933|Primary|Safety - Mechanical Failure, Extrusion, Erosion, or Migration of the Device Requiring Surgical or Medical Intervention|Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.|At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal|Subjects in whom device placement was attempted||Events|||Number
793063|NCT00894933|Primary|Safety - Urinary Retention Requiring Catheterization Post-Device Removal|Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.|At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal|Subjects in whom device placement was attempted||Events|||Number
793064|NCT00894933|Primary|Safety - Creation of a False Passage|Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.|At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal|Subjects in whom device placement was attempted||Events|||Number
793065|NCT00894933|Primary|Safety - Perforation of the Bowel or Bladder|Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.|At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal|Subjects in whom device placement was attempted||Events|||Number
793066|NCT00894933|Secondary|Intraoperative/Postoperative Parameters - Total Radical Prostatectomy Operative Time|To assess short-term clinical outcomes of the Device in facilitating the vesico-urethral anastomosis following a radical prostatectomy such as length of RP procedure.|At Device placement|Subjects in whom device placement was attempted||Minutes||Standard Deviation|Mean
793067|NCT00894933|Secondary|Intraoperative/Postoperative Parameters - Total Device Placement Time|To assess short-term clinical outcomes of the Device in facilitating the vesico-urethral anastomosis following a radical prostatectomy such as length of Device placement.|At Device placement|Subjects in whom device placement was attempted||Minutes||Standard Deviation|Mean
793068|NCT00894933|Secondary|Extravasation During Post-placement Cystogram at Either the First or Second Device Removal Attempts||7-10 and 13 - 15 days post-Device placement|Subjects with successful device placement||participants|||Number
793069|NCT00894933|Secondary|Intraoperative/Postoperative Parameters - Estimated Blood Loss|To assess short-term clinical outcomes of the Device in facilitating the vesico-urethral anastomosis following a radical prostatectomy such as blood loss.|At Device placement|Subjects in whom device placement was attempted||cc||Standard Deviation|Mean
793070|NCT00894933|Primary|Functionally Adequate Vesico-urethral Anastomosis Within 21 Days Post-Device Placement in Subjects With Successful Device Placement|Evaluated by the proportion of Subjects who have had a successful Device placement and developed a functionally adequate anastomosis within 21 days post procedure (i.e. minimal or no extravasation noted during post-placement)|7-21 days post-Device placement|||participants|||Number
793071|NCT00894933|Primary|Successful Device Placement|Defined as the establishment of a water-tight anastomosis immediately post-Device placement.|At Device placement|Subjects in whom device placement was attempted (i.e. treated subjects)||participants|||Number
793072|NCT00894933|Primary|Safety - Infection That Requires IV Antibiotics or Re-hospitalization|Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.|At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal|Subjects in whom device placement was attempted||Events|||Number
793073|NCT00895011|Primary|Change in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Score|Questionnaire assesses subject's evaluation of erectile function over the previous 4-week period. Total scores from questions 1-5 & 15 range from 1 to 30. A higher score indicates better erectile function.|Baseline, End of Treatment (up to 12 weeks)|Number of participants analyzed represents the Intent-to-Treat population. For dropouts or missing data, the last observation carried forward convention was used.||scores on a scale||Standard Error|Least Squares Mean
793074|NCT00895011|Primary|The Change in Percentage of Sexual Attempts in Which Subjects Are Able to Insert the Penis Into the Partner's Vagina|"Data presented as mean change from baseline in the percentage of Yes responses to Sexual Encounter Profile (SEP) diary question 2 Were you able to insert your penis into your partner's vagina?"|Baseline, Week 12|Number of participants analyzed represents the Intent-to-Treat population.||Percentage of Sexual Attempts||Standard Deviation|Least Squares Mean
793075|NCT00895011|Primary|Change in Percentage of Sexual Attempts in Which Subjects Are Able to Maintain an Erection of Sufficient Duration to Have Successful Intercourse|"Data presented as mean change from baseline in the percentage of Yes responses to Sexual Encounter Profile (SEP) diary question 3 Did your erection last long enough for you to have successful intercourse?"|Baseline, Week 12|Number of participants analyzed represents the Intent-to-Treat population.||percentage of sexual attempts||Standard Error|Least Squares Mean
793076|NCT00895180|Secondary|Percentage of Participants With Anti-Ramucirumab Antibodies (ADA)|Percentage of Participants with Treatment Emergent (TE) anti-ramucirumab antibodies were participants with a 4-fold increase (2 dilutions) increase over a positive baseline antibody titer or for a negative baseline titer, a participant with an increase from the baseline to a level of 1:20.|Start of Treatment to 30-day Post Infusion Follow Up (Up to 6 Months)|All enrolled participants who had any amount of ramucirumab and evaluable anti-ramucirumab antibodies.||percentage of participants|||Number
793077|NCT00895180|Secondary|Percentage of Participants With Anti-Olaratumab Antibodies (ADA)|Percentage of Participants with Treatment Emergent (TE) anti-olaratumab antibodies were participants with a 4-fold increase (2 dilutions) increase over a positive baseline antibody titer or for a negative baseline titer, a participant with an increase from the baseline to a level of 1:20.|Start of Treatment to 30-day Post Infusion Follow Up (Up to 6 Months)|All enrolled participant who had any amount of olaratumab and evaluable anti-olaratumab antibody data.||percentage of participants|||Number
793078|NCT00895180|Secondary|Pharmacodynamics (PD) Profiles||Cycle 7, Day 1: Prior to Infusion, 1 hr Post Infusion|Zero participants were analyzed for pharmacodynamic profile as the plasma collection procedure in this study was not fit for this purpose.|||||
793079|NCT00895180|Secondary|PK: Cmax and Cmin of Olaratumab||Cycle 3, Day 1: Prior to Infusion, 1 hr Post Infusion|All enrolled participants who received at least one dose of Olaratumab and had evaluable PK data.||μg/mL||Geometric Coefficient of Variation|Geometric Mean
793080|NCT00895180|Secondary|Pharmacokinetics (PK): Concentration Maximum (Cmax) and Concentration Minimum (Cmin) of Ramucirumab||Cycle 7, Day 1: Prior to Infusion,1 hour (hr) Post Infusion|All enrolled participants who received at least one dose of ramucirumab and had evaluable PK data.||microgram/milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
793081|NCT00895180|Secondary|Median Overall Survival (OS)|OS is the time from the start of treatment to the date of death. Participants who had not expired by the data analysis cutoff date were censored at their last date known to be alive.|Start of Treatment to Death Up To 27 Months|All enrolled participants who received at least one dose of study drug. Participants censored in ramucirumab = 4 and olaratumab = 4.||Weeks||95% Confidence Interval|Median
793082|NCT00895180|Secondary|Percentage of Participants (Pts) With Complete Response (CR), Partial Response (PR) and Minor Response (MR) (Objective Response Rate [ORR])|The pts achievement of both measurement and confirmation criteria for a status of CR, PR or MR based on the modified RANO criteria.CR requires all of the following:complete disappearance of all enhancing measurable and non-measurable disease sustained for at least 4 weeks (wks);no new lesions;no corticosteroids;and stable or improved clinically.PR requires all of the following:≥ 50% decrease compared with baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions sustained for at least 4 wks;no new lesions;stable or reduced corticosteroid dose;and stable or improved clinically.MR requires ≥ 25% reduction in sum of products of the perpendicular diameters of all measureable enhancing lesions sustained for at least 4 wks and no new lesions or progression of non-measurable lesions. PD is defined by any of these: ≥ 25% increase in sum of the products of perpendicular diameters of enhancing lesions;any new lesion;or clinical deterioration.|Start of Treatment to PD Up To 20 Months|All enrolled participants who received at least one dose of study drug.||percentage of participants|||Number
793083|NCT00895180|Secondary|Number of Participants With Treatment Emergent Adverse Events as Assessed by NCI CTCAE v4.0 (National Cancer Institute-Common Terminology Criteria for Adverse Events)|The number of participants who experienced serious adverse events (SAEs) that were considered to be related to ramucirumab or olaratumab. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.|Start of Treatment to End of Study (Up to 13 Months)|All enrolled participants who received at least one dose of study drug.||participants|||Number
793084|NCT00895180|Primary|Percentage of Participants Who Achieved Progression-Free Survival Rate at 6 Months (PFS-6)|PFS was defined as the start of treatment to the earliest date of tumor progression or death from any cause based on the modified Response Assessment in Neuro-Oncology Group through the American Society of Clinical Oncology (RANO) criteria. Progression is defined by any of the following: ≥ 25% increase in sum of the products of perpendicular diameters of enhancing lesions; any new lesion; or clinical deterioration. RANO is a standardized response criteria using bi-dimensional measurements of the largest contrast-enhancing area (Macdonald, 1990).|Start of treatment to PD or Death Up To 6 Months|All enrolled participants who received at least one dose of study drug.||percentage of participants|||Number
793121|NCT00895583|Secondary|Percentage of Participants Requiring Anti-Hypertensive Medication, Diabetes Agents, Lipid-Lowering Agents, or Erythropoiesis Stimuating Agents (ESAs)||Baseline, Months 12 and 24|ITT Population||percentage of participants|||Number
793085|NCT00895193|Primary|Maximum Flushing Severity Score|Flushing assessment performed hourly for six hours. Assessment of severity done using the validated visual analog scale (VAS) flushing assessment tool (FAST). Severity rated using a VAS from mild (1-3), moderate (4-6), severe (7-9) to very severe (10). The maximum severity score was the maximum severity score of each individual during the 6 hours of monitoring time period.|6 hours after dosing|All participants randomized to the study completed the study. Each arm had 25 participants.||units on a scale||Standard Deviation|Mean
793086|NCT00895193|Primary|Duration of Flushing|The amount of time, in minutes, that flushing lasted. Duration of individuals without experience flushing within 6 hours was set to 0 minutes.|6 hours after dosing|All participants randomized to the study completed the study. Each arm had 25 participants.||minutes||Standard Deviation|Mean
793087|NCT00895193|Primary|Time to Flushing|The time it took, in minutes, for a participant to experience any flushing. Time to flush for individuals that did not experience flushing within 6 hours was set to 360 minutes.|6 hours after dosing|All participants randomized to the study completed the study. Each arm had 25 participants.||minutes||Standard Deviation|Mean
793088|NCT00895193|Primary|Incidence of Flushing|Flushing assessment performed hourly for 6 hours after niacin administration. Incidence of flushing based on if the participant experience any niacin-induced flushing during the 6 hour period after dosing. Represents # of participants that experienced event.|Hourly for 6 hours on day of dosing|This was a single-site, randomized trial, 4-arm parallel design trial. Each arm consisted of 25 randomized participants. All participants completed the study.||participants|||Number
793089|NCT00895232|Secondary|Mean Change From Baseline to Day 84 for Total Periodic Limb Movements (PLM's)|Quantifies amount of leg movement|Baseline to Day 84|Only subjects who recorded PLM's/Hour at Baseline AND on Day 84.||PLM's per hour||Standard Deviation|Mean
793090|NCT00895232|Post-Hoc|Percentage (%) of Subjects Responding to Treatment From Baseline to Day 84 Based on Global Assessments by the Examiner.|Response is defined as any effect based on a scale of 0 through 4 where 0 = no effect, 1 = mild effect, 2 = moderate effect, 3 = marked effect, and 4 = dramatic effect.|Baseline to Day 84|Only subjects who were evaluated at Baseline AND on Day 84||percent of participants|||Number
793091|NCT00895232|Primary|Mean Change From Baseline to Day 84 for International Restless Leg Syndrome Study Group (IRLSSG) Scale|Validated rating scale of RLS symptoms (Range 1 [mild] - 40 [severe])|Baseline to Day 84|Only subjects who completed the IRLSSG Rating Scale at baseline AND on Day 84.||units on a scale||Standard Deviation|Mean
793092|NCT00895245|Secondary|Impact of Cisplatin-induced Nausea and Vomiting on Daily Life During the 5 Day Period Following Cisplatin Infusion for Multiple Cycles as Measured by the Functional Living Index-Emesis Questionnaire|"FLIE is a patient-completed quality of life assessment modified from the original Functional Living Index – Cancer questionnaire. FLIE contains two domains: nausea and vomiting with nine items in each domain. The first item asks the patient to rate how much nausea (or vomiting) has occurred over a 5 day period. The remaining eight items ask patients to rate the impact of nausea (or vomiting) on various aspects of a patient’s life (for example, ability to enjoy meals/liquids). Each item is answered using a 7 point visual analog scale with 7 being none /not at all and 1 being a great deal. The two domains are summed for a total score with a possible range of 18-126. Higher scores indicate a more favorable quality of life. A total score of >108 defines those patients who had a minimal impact of CINV on quality of life. All particpants discontinued the trial after one cycle of cisplatin."|5 days following cisplatin infusion|Two patients did not complete the Functional Living Index-Emesis (FLIE) Questionnaire.||units on a scale||Full Range|Mean
793093|NCT00895245|Secondary|Control of Nausea for 120 Hours Following Each Cisplatin Infusion for Multiple Cycles of Therapy as Measured by the Visual Analog Scale|"The visual analog scale ranges from 0-100. 0 is labeled as no nausea and 100 is labeled as nausea as bad as it could be A score of < 25 is considered to indicate no significant nausea. All patients discontinued trial after only one cisplatin infusion."|120 hours following cisplatin infusion|||millimeters||Full Range|Mean
793094|NCT00895245|Secondary|Rate of Complete Response to Anti-emetic Therapy in the Delayed Setting (25-120 Hours After Cisplatin Infusion)||25-120 hours following cisplatin infusion|||Participants|||Count of Participants
793095|NCT00895245|Primary|Proportion of Patients With a Complete Response to the Anti-emetic Medication Regimen|Complete response is defined as no emesis or rescue nausea medications needed in the first 120 hours following cisplatin infusion.|120 hours following cisplatin infusion|||Participants|||Count of Participants
793096|NCT00895284|Primary|Total Procedure Time - Skin Incision to Skin Closure||At skin closure.|The study was terminated due to lack of funding; due to the small sample size, no analysis was done.|||||
793097|NCT00895310|Secondary|Duration of Stable Disease||From date of enrollment, every Cycle (4 weeks), until disease progression, unacceptable toxicities, study withdrawal, or death from any cause, whichever came first, assessed up to 2 years|||Days||Full Range|Median
793098|NCT00895310|Secondary|Progression Free Survival|Response Evaluation Criteria In Solid Tumors (RECIST) radiographic criteria for progression|From date of enrollment, every Cycle (4 weeks), until disease progression, unacceptable toxicities, study withdrawal, or death from any cause, whichever came first, assessed up to 2 years|||Days||95% Confidence Interval|Median
793099|NCT00895310|Secondary|PSA Response (>30% From Baseline)||From date of enrollment, every Cycle (4 weeks), until disease progression, unacceptable toxicities, study withdrawal, or death from any cause, whichever came first, assessed up to 2 years|||Participants|||Count of Participants
793100|NCT00895310|Primary|Prostate Specific Antigen (PSA) Response (>50% Reduction From Baseline)|Percentage of patients who achieved a clinically significant decline in Prostate Specific Antigen (PSA) after initiation of ketoconazole therapy, defined as a >=50% decrease in PSA.|From date of enrollment, every Cycle (4 weeks), until disease progression, unacceptable toxicities, study withdrawal, or death from any cause, whichever came first, assessed up to 2 years|||Participants|||Count of Participants
793101|NCT00895453|Primary|Candida Culture Free After Maintenance Therapy|candida culture free (monthly vaginal cultures were obtained)|12 months|||participants|||Number
793102|NCT00895531|Primary|Postoperative Pain|Pain as reported on a verbal rating scale ( VRS) (0–10, 0 = no pain, 10 = worse pain imaginable).|48 hours|||units on a scale||Standard Deviation|Mean
793424|NCT00904371|Secondary|Additional Antihypertensive Treatment Pattern at Visit 3 (End of Study)|Participants may have taken more than one antihypertensive treatment, so the percentages will not add to 100 percent.|3rd visit (4-10 months)|Patients with data at 3rd visit (4-10 months)||Percentage of participants|||Number
793103|NCT00895583|Secondary|Percentage of Participants With Malignancy|Includes any adverse events based on categorization by the investigator as 'malignancy', regardless of the event preferred term in MedDRA.|From randomization up to 24 months after transplantation (On-Therapy)|Safety Population||percentage of participants|||Number
793104|NCT00895583|Secondary|Percentage of Participants With Polyomavirus Infection|Includes adverse event terms reported by the investigator to be attributed to the organism 'polyomavirus', regardless of the preferred term in MedDRA.|From randomization up to 24 months after transplantation (On-Therapy)|Safety Population||percentage of participants|||Number
793105|NCT00895583|Secondary|Percentage of Participants With Cytomegalovirus (CMV) Infection|Includes adverse event terms reported by the investigator to be attributed to the organism 'cytomegalovirus', regardless of the preferred term in MedDRA.|From randomization up to 24 months after transplantation (On-Therapy)|Safety Population||percentage of participants|||Number
793106|NCT00895583|Secondary|Percentage of Participants With Infection|Includes adverse events based on categorization by the investigator as 'infection', regardless of the event preferred term in MedDRA.|From randomization up to 24 months after transplantation (On-Therapy)|Safety Population||percentage of participants|||Number
793107|NCT00895583|Secondary|Percentage of Participants With New-Onset Diabetes Receiving Treatment for Diabetes (Insulin and Non-Insulin)|Participants were considered as having new onset diabetes during the On-therapy period if any of the below events emerged between baseline and Month 12 or Month 24: 1) at least 30 days continuous, or at least 25 days non-stop (without gap) use of any diabetic treatment after randomization; 2) a fasting glucose ≥126 mg/dL after randomization; or 3) a non-fasting glucose ≥200 mg/dL after randomization.|12 Months and 24 Months|Safety Population. Only participants with new-onset diabetes mellitus at the beginning of the analysis interval were included; those with pre-existing diabetes were excluded from the analysis.||percentage of participants|||Number
793108|NCT00895583|Secondary|Percentage of Participants With New-Onset Diabetes|Participants were considered as having new onset diabetes during the On-therapy period if any of the below events emerged from baseline to Month 24: 1) at least 30 days continuous, or at least 25 days non-stop (without gap) use of any diabetic treatment after randomization; 2) a fasting glucose greater than or equal to (≥)126 milligrams per deciliter (mg/dL) after randomization; or 3) a non-fasting glucose ≥200 mg/dL after randomization, were included in the new-onset diabetes population. Events at Months 12 or 24 occurred from baseline to On-therapy Month 12 and from On-therapy Months 12 to 24, respectively.|From Baseline to On-Therapy Month 12, from Baseline to On-Therapy Month 24, and from On-Therapy Month 12 up to On-Therapy Month 24|Safety Population; participants at risk of new-onset diabetes mellitus at the beginning of the analysis interval were included and those with pre-existing diabetes were excluded from the analysis. n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
793109|NCT00895583|Secondary|Change From Pre-Randomization to 12 Months Post-Transplantation in Body Mass Index (BMI; in Kilograms Per Square Meter [kg/m^2])|BMI = Weight (kg)/(Height*Height) (square meters [m^2]).|Baseline, Month 12|Safety Population||kg/m^2||Standard Error|Mean
793110|NCT00895583|Secondary|Change From Pre-Randomization to 12 Months Post-Transplantation in HOMA-Beta Cell (HOMA-B; Fasting)|"The Homeostasis Model Assessment (HOMA) estimates steady state beta cell function (%B) as a percentage of a normal reference population.
HOMA-B = 20 * insulin (µU/L) / fasting plasma glucose (mmol/L) minus (-) 3.5 Participants taking insulin within 12 hours were excluded from the analysis."|Baseline, Month 12|Safety Population||percentage beta cell function||Standard Error|Mean
793111|NCT00895583|Secondary|Change From Pre-Randomization to 12 Months Post-Transplantation in Homeostasis Model Assessment Insulin Resistance (HOMA-IR; Fasting)|"The HOMA-IR measures insulin resistance based on fasting glucose and insulin measurements:
HOMA-IR = fasting plasma glucose (mmol/L) multiplied by (*) fasting plasma insulin in microunits per liter (µU/L) divided by (/) 22.5.
Participants taking insulin within 12 hours were excluded from the analysis."|Baseline, Month 12|Safety Population||insulin resistance score||Standard Error|Mean
793112|NCT00895583|Secondary|Change From Pre-Randomization to 12 Months Post-Transplantation in Waist Circumference(Centimeters [cm])||Baseline, Month 12|Safety Population||cm||Standard Error|Mean
793113|NCT00895583|Secondary|Change From Pre-Randomization to 12 Months Post-Transplantation in Weight (Kilograms [kg])||Baseline, Month 12|Safety Population||kg||Standard Error|Mean
793114|NCT00895583|Secondary|Change From Pre-Randomization to 12 Months Post-Transplantation in Fasting Insulin (Picomoles Per Liter [Pmol/L])||Baseline, Month 12|Safety Population||pmol/L||Standard Error|Mean
793115|NCT00895583|Secondary|Change From Pre-Randomization to 12 Months Post-Transplantation in Fasting Glucose (mmol/L)||Baseline, Month 12|Safety Population||mmol||Standard Error|Mean
793116|NCT00895583|Secondary|Change From Pre-Randomization to 12 Months Post-Transplantation in Hemoglobin A1C (Liter Per Liter [L/L])|Ratio of hemoglobin A1c to normal hemoglobin.|Baseline, Month 12|Safety Population||L/L||Standard Error|Mean
793117|NCT00895583|Secondary|Percentage of Participants Requiring Treatment for Stomatitis by Treatment Type|Included treatments (analgesics, dental paste, topical antifungal, topical steroids, or other) prior to randomization, during the on-therapy period (up to 19 to 21 months post-randomization) and the off-therapy period (up to 24 months post-transplantation).|On-Therapy Period (up to 21 months post-randomization) and Off-Therapy Period (up to 24 months post-transplantation)|ITT Population||percentage of participants|||Number
793118|NCT00895583|Secondary|Percentage of Participants With Stomatitis|Includes adverse events based on categorization by the investigator as stomatitis, regardless of the event preferred term in Medical Dictionary for Regulatory Activities (MedDRA)|From randomization up to 24 months after transplantation (On-Therapy)|Safety Population||percentage of participants|||Number
793119|NCT00895583|Secondary|Percentage of Participants With Angiotensin Converting Enzyme Inhibitor (ACEI) or Angiotensin II Receptor Block (ARB) Use|Included ACEI or ARB use prior to randomization, during the on-therapy period (up to 19 to 21 months post randomization) and the off-therapy period (up to 24 months post-transplantation).|Pre-randomization, On-Therapy Period (up to 21 months post-randomization), and Off-Therapy Period (up to 24 months post-transplantation)|ITT Population||percentage of participants|||Number
793120|NCT00895583|Secondary|Spot and 24 Hour Urine Protein to Creatinine Ratio (UPr/Cr)|Baseline was defined as the last nonmissing assessment before or on the date of the first dose of test article.|Baseline and Months 12 and 24|Safety Population; n=number of participants assessed for the specified parameter at a given visit.||UPr/Cr||Standard Deviation|Mean
793122|NCT00895583|Secondary|Change From Baseline (Pre-Randomization) to 12 and 24 Months Post-Transplantation in Fasting Lipid Parameters (Millimoles Per Liter [mmol/L])|Parameters assessed included total cholesterol (TC), triglycerides, low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C); collected when participant was in a fasting state.|Baseline, Months 12 and 24|Safety Population; n=number of participants assessed for the specified parameter at a given visit.||mmol/L||Standard Error|Mean
793123|NCT00895583|Secondary|Percentage of Participants With Anemia, Thrombocytopenia, or Leukopenia|Anemia was defined as hemoglobin less than or equal to (≤)10 grams per deciliter (g/dL); leukopenia was defined as white blood cell (WBC) count ≤2000 per cubic millimeters (/mm^3); and thrombocytopenia was defined as platelets ≤100,000/mm^3. Baseline was defined as the last nonmissing assessment before or on the date of the first dose of test article.|Baseline, Months 12 and 24|Safety Population; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
793124|NCT00895583|Secondary|Percentage of Participants With Antibody Use in Treatment of Acute Rejection|Number of participants who experienced an adverse event (AE) of rejection was used as the denominator in the determination of percentage of participants with antibody use in treatment of acute rejection.|On Therapy Period (up to 21 months post-randomization) and Off-Therapy Period (up to 24 months post-transplantation)|Safety Population; only participants with an AE of rejection were included in the analysis.||percentage of participants|||Number
793125|NCT00895583|Secondary|Number of Participants With BCAR by Severity of First BCAR and Time of Onset From Post-Randomization to 6, 12, 18, and 24 Months Post-Transplant|BCAR was categorized as antibody-mediated (AM) or T-cell. AM BCAR severity was graded as Grade I (mild), Grade II (moderate), and Grade III (severe). T-cell BCAR severity was graded as 'Grade Ia, Ib (mild), Grade IIa, IIb (moderate), and Grade III (severe). If a participant had both T-cell BCAR and antibody-mediated BCAR on the first rejection, the participant was counted in each category.|Months 6, 12, 18, and 24|ITT Population||participants|||Number
793126|NCT00895583|Secondary|Percentage of Participants With First On-Therapy BCAR From Transplantation Occurring at 12 and 24 Months|Defined as the first BCAR occurring during the On-Therapy period based on the ITT population. Time to first BCAR was the days from transplantation to the date of BCAR.|Months 12 and 24|ITT Population||percentage of participants|||Number
793127|NCT00895583|Secondary|Percentage of Participants With BCAR Post-Randomization to 6, 12, 18, and 24 Months Post-Transplantation|BCAR was defined according to updated Banff criteria (2007) for renal allograft rejection.|Post-Randomization to 6, 12, 18, and 24 months Post-Transplantation|ITT Population||percentage of participants|||Number
793128|NCT00895583|Secondary|Percentage of Participants With Graft Loss (Including Death) at 12 and 24 Months Post-Randomization|Graft loss was defined as physical loss (nephrectomy or retransplantation), functional loss (requiring dialysis for ≥56 days with no return of graft function), or death.|Post-randomization to Months 12 and 24 Post-Transplantation|ITT Population||percentage of participants|||Number
793129|NCT00895583|Secondary|Percentage of Participants With Biopsy-Confirmed Acute Rejection (BCAR), Graft Loss, or Death From Randomization to 24 Months Post-Transplantation|Biopsy-confirmed acute rejection was defined according to updated Banff criteria (2007) for renal allograft rejection. Graft loss was defined as physical loss (nephrectomy or retransplantation), functional loss (requiring dialysis for greater than or equal to [≥]56 days with no return of graft function), or death.|Post-randomization to Month 24 post-transplantation|ITT Population||percentage of participants|||Number
793130|NCT00895583|Secondary|Change From Randomization in Serum Creatinine (On-Therapy Analysis)|Serum creatinine was measured in mcmol/L. Baseline was defined as the last assessment prior to first administration of study drug.|Baseline, Months 6, 12, 18, and 24|On-Therapy Population: all participants who remained on assigned study therapy up to the point of discontinuation. n=number of participants assessed for the specified parameter at a given visit.||mcmol/L||Standard Error|Mean
793131|NCT00895583|Secondary|Serum Creatinine (On-Therapy Analysis)|Serum creatinine was measured in micromillimoles per liter (mcmol/L). Baseline was defined as the last nonmissing assessment before or on the date of the first dose of test article.|Baseline, Months 6, 12, 18, and 24|On-Therapy Population: all participants who remained on assigned study therapy up to the point of discontinuation. n=number of participants assessed for the specified parameter at a given visit.||mcmol/L||Standard Deviation|Mean
793132|NCT00895583|Secondary|Slope of Calculated GFR (MDRD) From Randomization to 24 Months Post-Transplantation (On-Therapy Analysis)|GFR was calculated using the MDRD equation using either serum creatinine traceable to IDMS or serum creatinine not traceable to IDMS. Timepoints were calculated as study days, relative to the time of randomization of study medication. All available on-therapy values were included. Observed data were multiplied by a scale factor of 365, expressing the slope as an annual change.|Baseline, Month 24|On-Therapy analysis of the slope comprised the data collected from the on-therapy evaluations for all the participants in the ITT population; data collected from participants receiving sirolimus during the first 3 weeks post-randomization for safety monitoring were excluded from the analysis.||mL/min/1.73 m^2 per year||95% Confidence Interval|Mean
793133|NCT00895583|Secondary|Change From Randomization in Calculated GFR Using MDRD (On-Therapy Analysis)|GFR was calculated using the MDRD equation using either serum creatinine traceable to IDMS or serum creatinine not traceable to IDMS. Baseline was defined as the last nonmissing assessment before or on the date of the first dose of test article.|Baseline, Months 6, 12, 18, and 24|On-Therapy Population; n=number of participants assessed for the specified parameter at a given visit.||mL/min/1.73 m^2||Standard Error|Mean
793134|NCT00895583|Secondary|Calculated GFR Using MDRD (On-Therapy Analysis)|GFR was calculated using the MDRD equation using either serum creatinine traceable to IDMS or serum creatinine not traceable to IDMS. Baseline was defined as the last nonmissing assessment before or on the date of the first dose of test article.|Baseline, Months 6, 12, 18, and 24|On-Therapy Population: all participants who remained on assigned study therapy up to the point of discontinuation. number (n)=number of participants assessed for the specified parameter at a given visit.||mL/min/1.73 m^2||Standard Deviation|Mean
793135|NCT00895583|Secondary|Percentage of Participants With Improvement of ≥10 mL/Min/m^2 in Calculated GFR at 12 and 24 Months Post-Transplantation|GFR was calculated using the MDRD equation using either serum creatinine traceable to IDMS or serum creatinine not traceable to IDMS.|Baseline, Months 12 and 24|ITT Population. Missing GFR was imputed as follows: 1) GFR=0 after graft loss and 2) last observed value prior to missing was carried forward for death (with functioning graft), early termination or skipped assessment.||percentage of participants|||Number
793136|NCT00895583|Secondary|Percentage of Participants With Improvement of ≥7.5 mL/Min/m^2 in Calculated GFR at 12 and 24 Months Post-Transplantation|GFR was calculated using the MDRD equation using either serum creatinine traceable to IDMS or serum creatinine not traceable to IDMS.|Baseline, Months 12 and 24|ITT Population. Missing GFR was imputed as follows: 1) GFR=0 after graft loss and 2) last observed value prior to missing was carried forward for death (with functioning graft), early termination or skipped assessment.||percentage of participants|||Number
793137|NCT00895583|Secondary|Percentage of Participants With Improvement of ≥5 mL/Min/m^2 in Calculated GFR at 12 and 24 Months Post-Transplantation (Intent-to-Treat [ITT] Analysis)|GFR was calculated using the MDRD equation using either serum creatinine traceable to IDMS or serum creatinine not traceable to IDMS.|Baseline, Months 12 and 24|ITT Population: all randomized participants who received at least 1 dose of the assigned therapy after randomization. Missing GFR was imputed as follows: 1) GFR equals (=)0 after graft loss and 2) last observed value prior to missing was carried forward for death (with functioning graft), early termination or skipped assessment.||percentage of participants|||Number
793138|NCT00895583|Secondary|Percentage of Participants With Improvement of ≥5 mL/Min/m^2 in Calculated GFR at 12 Months Post-Transplantation (On-Therapy Analysis)|GFR was calculated using the MDRD equation using either serum creatinine traceable to IDMS or serum creatinine not traceable to IDMS.|Baseline, Month 12|On-Therapy Population (12 Months): all randomized participants who remained on assigned study therapy through 12 months post-transplantation.||percentage of participants|||Number
793139|NCT00895583|Primary|Percentage of Participants With Improvement of Greater Than or Equal to [≥]5 Milliliters Per Minute Per 1.73 Square Meters (mL/Min/m^2) in Calculated Glomerular Filtration Rate (GFR) at 24 Months Post-Transplantation (On-Therapy Analysis)|GFR was calculated using the Modified Diet in Renal Disease (MDRD) equation using either serum creatinine traceable to isotope dilution mass spectrometry (IDMS) or serum creatinine not traceable to IDMS.|Baseline, Month 24|On-Therapy Population (24 Months): all randomized participants who remained on assigned study therapy through 24 months post-transplantation.||percentage of participants|||Number
793140|NCT00895661|Secondary|Incidence of Severity of Infusion Reactions, Infections and Neutropenia|Toxicity grades: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening|24 months|||Participants|||Count of Participants
793141|NCT00895661|Secondary|Progression-free Survival (PFS)|"Progressive Disease (PD) or Relapsed Disease (RD):
Appearance of a new lesion(s) > 1.5 cm in any axis, ≥ 50% increase in SPD of more than one node, or ≥50% increase in longest diameter of a previously identified node > 1 cm in short axis.
>50% increase from nadir in the SPD of any previous lesions PFS is number of participants who have not died or had PD or RD."|5 years|||Participants|||Count of Participants
793142|NCT00895661|Secondary|Overall Response Rate (ORR)|"Complete Response (CR): see definition in primary outcome
Partial Response (PR):
≥50% decrease in SPD of up to 6 largest dominant masses
No new sites of disease or increase in the size of the other nodes, liver, or spleen.
Splenic and hepatic nodules must regress by at least 50% in the SPD.
Overall Response (OR) = CR + PR."|after a median number of 8 maintenance cycles, up to 24 weeks|||Participants|||Count of Participants
793143|NCT00895661|Primary|Determine Complete Response Rate (CRR) of Increased Dose Rituximab in Indolent B-cell Lymphomas|"CR requires all of the following:
Regression to normal size on CT (≤ 1.5 cm in their greatest transverse diameter for nodes ≥ 1.5 cm before therapy). Previously involved nodes that were 1.1 to 1.5 cm in their greatest transverse diameter before treatment must have decreased to <1 cm in their greatest transverse diameter after treatment, or by more than 75% in the sum of the products of the greatest diameters (SPD).
The spleen, if considered to be enlarged before therapy on the basis of a CT scan, must have regressed in size and must not be palpable on physical examination.
If bone marrow is known to be involved at the beginning, then repeat biopsy documents clearance"|after a median number of 8 maintenance cycles, up to 24 weeks|||Participants|||Count of Participants
793144|NCT00895752|Secondary|Extra-cellular Signal-relatedness Kinase (ERK)|ERK activations times, as defined as the time in minutes for ERK phosphorylation to reach the half maximal level.|Screen and Week 6|||minutes||Standard Deviation|Mean
793145|NCT00895752|Secondary|The Social Reciprocity Scale|The 65-item SRS is a standardized measure of the core symptoms of autism. Each item is scored on a 4-point Likert scale. The score of each individual item is summed to create a total raw score. A total scores results are as follows: 0-62: Within normal limits 63-79: Mild range of impairment 80-108: Moderate range of impairment 109-149: Severe range of impairment.|Week 6|||units on a scale||Standard Deviation|Mean
793146|NCT00895752|Secondary|The Peabody Picture Vocabulary Test|The Peabody Picture Vocabulary Test is one of the most commonly used assessment tests that measure verbal ability in standard American English vocabulary. This test has been nationally standardized using examinees from various age groups, from children to adults. Thus, the raw scores are equated to mental age, using the norms obtained from standardization. The total standard scores range from 40 (worse receptive vocabulary) to 160 (better receptive vocabulary). The scores can also be converted to percentile rank.|Week 6|||units on a scale||Standard Deviation|Mean
793147|NCT00895752|Secondary|The Clinical Global Impression - Severity Scale|The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill|Week 6|||units on a scale||Standard Deviation|Mean
793148|NCT00895752|Secondary|The ADHD Rating Scale|The ADHD Rating Scale is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder. The ADHD Rating Scale-IV is completed by the parent and scored by a clinician. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. The total score can range from 0 to 54, with a higher score indicating greater severity|Week 6|||units on a scale||Standard Deviation|Mean
793190|NCT00896025|Primary|The Primary Outcome is to Compare All Patients Who Survive (With or Without Transplant) to Those Who Die.||3 Weeks, 1-year and 2-year follow-ups|The estimated minimum enrollment for any statistical validity was 100 patients. Due to low enrollment (8 participants) and the likelihood of generating any meaningful study data moving forward, the DSMB recommended the early termination of the study. Zero participants were analyzed because the small sample size would not yield meaningful results|||||
793149|NCT00895752|Secondary|Aberrant Behavior Checklist|The Aberrant Behavior Checklist (ABC) is a 58-item measure of maladaptive behaviors and is used as a measure of drug effects. The ABC has 5 subscales: Social Withdrawal (16 items) ranging from 0 (not at all) to 48 (severe), Irritability (15 items) ranging from 0 (not at all) to 45 (severe), Inappropriate Speech (4 items) ranging from 0 (not at all) to 12 (severe), Hyperactivity (16 items) ranging from 0 (not at all) to 48 (severe), and Stereotypy (7 items) ranging from 0 (not at all) to 21 (severe). Items are rated from 0 (not at all) to 3 (severe).|Week 6|||units on a scale||Standard Deviation|Mean
793150|NCT00895752|Primary|Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)|The CY-BOCS PDD has been utilized in a largescale clinical treatment study of repetitive behavior in idiopathic ASDs. CYBOCS-PDD scores range from 0 to 20 and measure repetitive/compulsive behavior and not obsessions. Higher score indicate worse outcome.|Obtained at Baseline and Week 6|||Units on a Scale||Standard Deviation|Mean
793151|NCT00895752|Primary|Clinical Global Impression-Improvement (CGI-I)|The Clinical Global Impression – Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse|Obtained at Week 6|||units on a scale||Full Range|Mean
793152|NCT00895817|Secondary|Endoscopic Change|Following therapy, resolution of EE findings will be assessed.|8 weeks||||||
793153|NCT00895817|Secondary|Symptom Score|Using a validated questionnaire, symptoms will be assessed at baseline and following therapy.|8 weeks||||||
793154|NCT00895817|Primary|Number of Participants Who Responded|Histologic resolution of esophageal eosinophilia. Response is defined as achieving < 7 eosinophils/high power field in both the proximal and distal esophagus.|8 weeks|Sample size estimation was based on the assumptions:10% of the EE patients will respond to PPI compared to 55% of patients treated with steroids. Controlling the probability of a Type I error at alpha=0.05, a sample of 38 patients in the treatment groups (19 in each arm) will have 80% power to detect a difference in treatment response of 45%.||participants|||Number
793155|NCT00895830|Primary|Experienced Post-operative Nausea or Vomiting||24 hours|ITT||participants|||Number
793156|NCT00895843|Secondary|Pain Control/Relief|Patient satisfaction scores|48 hours after surgery (end of study)||||||
793157|NCT00895843|Secondary|Time to Rescue|Time taken for rescue medication requirement|Between 30mins and 48 hours||||||
793158|NCT00895843|Secondary|Mean Pain Intensity|Mean VAS scores of pain intensity for each time points|30 mins, 1 hour, 6 hours, 24 hours and 48 hours after surgery||||||
793159|NCT00895843|Primary|Number of Patients Needing Rescue Medication|Number of patients who required rescue medication within 6 hours|At 6 hours|||Participants|||Number
793160|NCT00895895|Secondary|Percentage of Participants Who Were Responders at Week 24|Responder defined as a participant who demonstrated an improvement of at least 3 points from baseline in the ADAS-Cog total score and no worsening in the DAD total score and in ADCS-CGIC. Participants were considered a responder at Week 24 if all 3 criteria were met.|Week 24|ITT; N=number of participants with evaluable data||percentage of participants|||Number
793161|NCT00895895|Secondary|Change From Baseline in CANTAB RTI Simple Reaction Time at Week 24|CANTAB-RTI assessed participant’s reaction, movement time and vigilance during simple (1 choice) reaction time trial and also measured anticipatory/premature responses. In the test, 1 yellow spot appeared on a computer screen in 1 location, the participant responded by letting go of a press pad and touching the screen where the spot appeared. Simple Reaction Time was the time from appearance of yellow spot on computer screen to time to release press pad in trials the participant responded correctly. Total ranged from 100 to 5100 (maximum allowed) msec, lower score indicated better performance.|Baseline, Week 24|ITT; N=number of participants with evaluable data||msec||Standard Deviation|Mean
793162|NCT00895895|Secondary|Change From Baseline in CANTAB RTI Simple Movement Time at Week 24|CANTAB-RTI assessed participant’s reaction, movement time and vigilance during simple (1 choice) reaction time trial and also measured anticipatory/premature responses. In the test, 1 yellow spot appeared on a computer screen in 1 location, the participant responded by letting go of a press pad and touching the screen where the spot appeared. Simple Movement Time was the time from release of press pad to touch the screen where the spot had been in trials the participant responded correctly. Total ranged from 100 to 5100 (maximum allowed) msec, lower score indicated better performance.|Baseline, Week 24|ITT; N=number of participants with evaluable data||msec||Standard Deviation|Mean
793163|NCT00895895|Secondary|Change From Baseline in CANTAB RTI Five-Choice Reaction Time at Week 24|CANTAB-RTI assessed participant’s reaction, movement time and vigilance during 5-choice reaction time trial and also measured anticipatory/premature responses. In the test, a yellow spot appeared on a computer screen in 1 of 5 locations, the participant responded by letting go of a press pad and touching the screen where the spot appeared. 5-Choice Reaction Time was the time from appearance of yellow spot on computer screen to time to release press pad in trials the participant responded correctly. Total ranged from 100 to 5100 (maximum allowed) msec, lower score indicated better performance.|Baseline, Week 24|ITT; N=number of participants with evaluable data||msec||Standard Deviation|Mean
793164|NCT00895895|Secondary|Change From Baseline in CANTAB RTI Five-Choice Movement Time at Week 24|CANTAB-RTI assessed participant’s reaction, movement time and vigilance during 5-choice reaction time trial and also measured anticipatory/premature responses. In the test, a yellow spot appeared on a computer screen in 1 of 5 locations, the participant responded by letting go of a press pad and touching the screen where the spot appeared. 5-Choice Movement Time was the time from release of press pad to screen touch where the spot had been in trials the participant responded correctly. Possible score ranged from 100 to 5100 msec, lower score indicated better performance.|Baseline, Week 24|ITT; N=number of participants with evaluable data||msec||Standard Deviation|Mean
793165|NCT00895895|Secondary|Change From Baseline in CANTAB Reaction Time (RTI) Five-Choice Accuracy at Week 24|CANTAB-RTI assessed participant’s reaction, movement time and vigilance during a 5-choice reaction time trial and to measure anticipatory/premature and perseverative responses. In the trial, a yellow spot appeared on a computer screen in 1 of 5 locations, the participant responded by letting go of a press pad and touching the screen where the spot appeared. 5-Choice Accuracy was the total number of trials where participant responded correctly. Total ranged from 0 to 30, higher score indicated better performance.|Baseline, Week 24|ITT; N=number of participants with evaluable data||correct trials||Standard Deviation|Mean
793166|NCT00895895|Secondary|Change From Baseline in CANTAB PRM-Percentage Correct at Week 24|CANTAB-PRM assessed participant’s visual pattern recognition memory in a 2-choice forced discrimination paradigm. Participants presented with a series of 12 visual patterns singly. In recognition phase, participants were required to choose between a pattern previously seen and a novel pattern. Patterns in the recognition phase appeared sequentially in reverse order on the screen. Assessment was repeated with 12 new patterns. Correct response total expressed as a percentage, ranged from 0 to 100, higher scores indicated better performance.|Baseline, Week 24|ITT; N=number of participants with evaluable data||percentage of correct answers||Standard Deviation|Mean
793167|NCT00895895|Secondary|Change From Baseline in CANTAB Pattern Recognition Memory (PRM)-Mean Correct Latency at Week 24|CANTAB-PRM assessed participant’s visual pattern recognition memory in a 2-choice forced discrimination paradigm. Participants presented with a series of 12 visual patterns singly. In recognition phase, participants were required to choose between a pattern previously seen and a novel pattern. Patterns in the recognition phase appeared sequentially in reverse order on the screen. Assessment was repeated with 12 new patterns. Latency in correct responses ranged from 0 to infinity millisecond (msec), lower scores indicated better performance.|Baseline, Week 24|ITT; N=number of participants with evaluable data||msec||Standard Deviation|Mean
793168|NCT00895895|Secondary|Change From Baseline in CANTAB SWM Strategy at Week 24|CANTAB-SWM assessed participant’s ability to strategize. Participant was asked to find tokens in on-screen boxes and move them. Difficulty ranged from 4 to 8 box assessments, 2 trials per assessment. Strategy score was the number of unique boxes the participant searched in the two 6 and 8 box trials. 6 box trial scores ranged from 1 (1 box searched for all 6 tokens) to 6 (6 boxes searched for 6 tokens). 8 box trial score ranged from 1 (1 box searched) to 8 (8 boxes searched for 8 tokens). Total of the 4 trial scores ranged from 4 to 28. Lower score indicated better performance.|Baseline, Week 24|ITT; N=number of participants with evaluable data||boxes||Standard Deviation|Mean
793169|NCT00895895|Secondary|Change From Baseline in CANTAB SWM - Between Errors (N Boxes) at Week 24|CANTAB-SWM assessed participant’s retention of spatial information, ability to manipulate remembered items and strategize. Participant was asked to find tokens in on-screen boxes and move them. Difficulty ranged from 4 to 8 box assessments, 2 trials for each assessment. Possible errors for each successful assessment: 4 box 0-38; 6 box 0-58; 8 box 0-78. Between Errors for N Boxes was the cumulative number of errors per each successful trial. Total scores ranged from 0 to 175. Lower scores indicated better performance.|Baseline, Week 24|ITT; N=number of participants with evaluable data||errors||Standard Deviation|Mean
793170|NCT00895895|Secondary|Change From Baseline in CANTAB SWM - Between Errors (8 Boxes) at Week 24|CANTAB-SWM assessed participant’s retention of spatial information, ability to manipulate remembered items and strategize. Participant asked to find tokens in on-screen boxes, move them. Difficulty ranged 4-8 boxes to assess, 2 trials per assessment. Between errors: number of times participant revisited a box where a token previously found. In 8 box assessments the maximum number of errors per trial was 40. Test ended with 40 errors in a trial. Less than 40 errors in both trials the participant went to the next level of difficulty. Scores ranged from 0 to 79. Lower scores: better performance.|Baseline, Week 24|ITT; N=number of participants with evaluable data||errors||Standard Deviation|Mean
793171|NCT00895895|Secondary|Change From Baseline in CANTAB-SWM - Between Errors (6 Boxes) at Week 24|CANTAB-SWM assessed participant’s retention of spatial information, ability to manipulate remembered items and strategize. Participant asked to find tokens in on-screen boxes, move them. Difficulty ranged 4-8 boxes to assess, 2 trials per assessment. Between errors: number of times participant revisited a box where a token previously found. In 6 box assessments the maximum number of errors per trial was 30. Test ended with 30 errors in a trial. Less than 30 errors in both trials the participant went to the next level of difficulty. Scores ranged from 0 to 59. Lower scores: better performance.|Baseline, Week 24|ITT; N=number of participants with evaluable data||errors||Standard Deviation|Mean
793172|NCT00895895|Secondary|Change From Baseline in CANTAB Spatial Working Memory (SWM) - Between Errors (4 Boxes) at Week 24|CANTAB-SWM assessed participant’s retention of spatial information, ability to manipulate remembered items and strategize. Participant asked to find tokens in on-screen boxes, move them. Difficulty ranged 4-8 boxes to assess, 2 trials per assessment. Between errors: number of times participant revisited a box where a token previously found. In 4 box assessments the maximum number of errors per trial was 20. Test ended with 20 errors in a trial. Less than 20 errors in both trials the participant went to the next level of difficulty. Scores ranged from 0 to 39. Lower scores: better performance.|Baseline, Week 24|ITT; N=number of participants with evaluable data||errors||Standard Deviation|Mean
793173|NCT00895895|Secondary|Change From Baseline in CANTAB PAL - First Trial Memory Score, Patterns at Week 24|CANTAB PAL-assessed visual memory/new learning using one or more patterns randomly displayed in boxes on a screen. Participants were to touch the box where patterns first appeared. Stage 1 (practice) and difficulty increased Stage 2 (2 patterns) to Stage 6 (6 patterns). When all locations correctly identified moved to next Stage. Test terminated when a stage could not be completed in 6 attempts. Total score was the number of correct choices made on the first attempt at each Stage. Total score ranged from 0 to 20, higher scores indicated better performance.|Baseline, Week 24|ITT; N=number of participants with evaluable data||correct choices||Standard Deviation|Mean
793174|NCT00895895|Secondary|Change From Baseline in CANTAB PAL - Number of Patterns Reached at Week 24|CANTAB PAL-assessed visual memory/new learning using one or more patterns randomly displayed in boxes on a screen. Participants were to touch the box where patterns first appeared. Stage 1 (practice) and difficulty increased Stage 2 (2 patterns) to Stage 6 (6 patterns). When all locations correctly identified moved to next Stage. Test terminated when a stage could not be completed in 6 attempts. Total score was the number of patterns presented at last stage successfully completed and ranged from 2 to 6, higher scores indicated better performance.|Baseline, Week 24|ITT; N=number of participants with evaluable data||patterns||Standard Deviation|Mean
793191|NCT00896038|Primary|PTSD Total Symptom Severity Score|PTSD total symptom severity was measured using the Clinician-Administered PTSD Scale (CAPS). This is a 30-item interview-based questionnaire that measures symptom severity during the past week. The total symptom severity score ranges from 0 (lowest symptom severity) to 136 (highest symptom severity).|Day 29 of the treatment period, 2 days after the final script presentation|The analysis included subjects who completed the CAPS at both baseline (Day 1) and Day 29, and who had data for the baseline covariates used in the analysis||units on a scale||Standard Error|Mean
793175|NCT00895895|Secondary|Change From Baseline in Cambridge Neuropsychological Test Automated Battery (CANTAB) Paired Associate Learning (PAL)Total Errors (N, Shapes, Adjusted) at Week 24|CANTAB PAL-assessed visual memory/new learning using one or more patterns randomly displayed in boxes on a screen. Participants were to touch the box where patterns first appeared. Stage 1 (practice) and difficulty increased Stage 2 (2 patterns) to Stage 6 (6 patterns). When all locations correctly identified moved to next Stage. Test terminated when a stage could not be completed in 6 attempts. Total Errors=total number of incorrect boxes chosen plus adjustment for estimated possible errors on problems, attempts, and recalls not reached. Total score 0 to 106, lower scores=better performance.|Baseline, Week 24|ITT; N=number of participants with evaluable data||errors||Standard Deviation|Mean
793176|NCT00895895|Secondary|Number of Participants With Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) Scores at Week 24|Caregiver and participant interview-based tool to rate the overall impression of participant’s clinical change of the disease over time. Areas covered in the interview include: relevant history, observation/evaluation, mental/cognitive state, behavior and functioning. Change categorized into 1 of 7 categories: marked improvement, moderate improvement, minimal improvement, no change, minimal worsening, moderate worsening, marked worsening.|Baseline, Week 24|ITT; N=number of evaluable participants||participants|||Number
793177|NCT00895895|Secondary|Change From Baseline in Neuropsychiatry Inventory (NPI) at Week 24|Caregiver interview-based rating scale assessed 10 behavioral, 2 neurovegetative disturbances occurring in dementia: delusions, hallucination, agitation/aggression, depression, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability, aberrant motor behavior, appetite/eating disorders and sleep/nightime behavior disorders. Each symptom score derived by symptom frequency (1 [occasionally] to 4 [very frequently] * symptom severity (1 [mild] to 3 [severe]) and ranged 0-12. Total score = sum of symptom scores; range 0-144, higher score indicating greater behavioral disturbances|Baseline, Week 24|ITT; N=number of participants with evaluable data||unit on a scale||Standard Deviation|Mean
793178|NCT00895895|Secondary|Change From Baseline in Disability Assessment for Dementia (DAD) Total Score at Week 24|Caregiver interview-based instrument assessing 10 areas of activities of daily living (ADL) to measure participant’s actual performance over the previous 2 weeks. Items included hygiene, dressing, continence, eating, meal preparation, telephoning, outings, finance/correspondence, medications and leisure/housework. Responses scored as 1 (yes) or 0 (no), response of “Not Applicable” was not scored. Total DAD score was sum of scores for 40 items, expressed as a percentage of the number of items answered yes or no. Total score ranged from 0 to 100, higher scores represented less disability in ADL.|Baseline, Week 24|ITT; N=number of participants with evaluable data||percentage of yes answers||Standard Deviation|Mean
793179|NCT00895895|Primary|Change From Baseline in the Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog) Total Score at Week 24|14-item scale to assess severity of cognitive impairment in Alzheimer's Disease. Items: word recall, naming objects and fingers, following commands, constructional praxis, ideational praxis, orientation, word recognition, recall of test instructions, spoken language ability, word-finding difficulty, comprehension of spoken language, concentration/distractibility, number cancellation and executive maze. Rating scale ranged from 0 (not present) to 5 (severe). Total score was sum of individual scores (items 1-11) and ranged from 0 to 70 with higher scores indicating greater cognitive impairment.|Baseline, Week 24|Intent to treat (ITT) population: randomized participants who took at least one dose of study medication, had a baseline evaluation and had at least one on-treatment post-baseline evaluation for the ADAS-Cog; Number of Participants Analyzed (N): number of evaluable participants||units on a scale||Standard Deviation|Mean
793180|NCT00895934|Secondary|Relapse-free Survival (RFS)|Estimated using Kaplan-Meier method. Logistic regression will be used as a tool to assess the association of various factors with the probability of response, recognizing that the power to detect statistically significant associations will be limited due to the sample size (and expected number of responses). The impact of remission and post-remission therapy on RFS will be assessed using Cox regression with remission and therapy treated as time-dependent covariates.|Up to 3 years||||||
793181|NCT00895934|Primary|Efficacy Defined as Best Response Achieved During Study Treatment Measured by Complete Remission (CR) Rate||Up to 3 years|||participants|||Number
793182|NCT00895934|Primary|Dose-limiting Toxicity and Maximum Tolerated Dose of Vorinostat (Phase I)||42 days||||||
793183|NCT00895947|Post-Hoc|Acute Respiratory Illness|"Number of subjects in each group meeting definition of acute respiratory illness (ARI), defined as 2 or more cold/flu symptoms reported in the same week. Further defined as febrile or afebrile depending on whether the subject reported the symptom of feverishness."|16 weeks|||participants|||Number
793184|NCT00895947|Secondary|Incidence/Severity of Viral Respiratory Infections|Number of subjects in each group with a confirmed viral respiratory infection and the proportion of subjects reporting a mild vs. moderate to severe infection|16 weeks|||participants|||Number
793185|NCT00895947|Secondary|Negative Events Related to Cold/Flu Symptoms|Number of subjects in each group reporting one or days of occurrence of the following 6 negative events: (1) felt sick, (2) missed work, (3) went to the doctor, (4) went to the pharmacy, (5) took cold/flu medication, and (6) skipped a planned activity|16 weeks|||participants|||Number
793186|NCT00895947|Secondary|Impact of Cold/Flu Symptoms|Number of subjects in each group reporting that cold/flu symptoms impacted the following 9 measures of daily life: ability to (1) think clearly, (2) sleep well, (3) breathe easily, (4) walk, climb stairs and exercise, (5) perform daily tasks, (6) work outside the home, (7) work inside the home, (8) interact with others, and (9) live personal life.|16 weeks|||participants|||Number
793187|NCT00895947|Secondary|Symptom Incidence/Severity|Number of subjects in each group reporting 13 different cold/flu symptoms assessed weekly|16 weeks|||participants|||Number
793188|NCT00895947|Primary|Frequency of Influenza-like Illness|Number of subjects in each group meeting the definition of influenza-like illness during treatment (i.e. those subject reporting one or more moderate to severe cold/flu symptoms during the treatment period).|16 weeks|Intent-to-treat, defined as all randomized subjects who took at least one dose of study drug||participants|||Number
793189|NCT00896025|Secondary|To Compare Patients Who Survive Without Transplantation to All Other Patients Enrolled in This Study (Those Who Receive a Transplant and Live, Those Who Receive a Transplant and Die, or Those Who Die Before Transplantation).||3 Weeks, 1-year and 2-year follow-ups||||||
793192|NCT00896038|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|90 minutes after the beginning of alcohol script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||units on a scale||Standard Error|Mean
793193|NCT00896038|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|75 minutes after the beginning of alcohol script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||units on a scale||Standard Error|Mean
793194|NCT00896038|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|60 minutes after the beginning of alcohol script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||units on a scale||Standard Error|Mean
793195|NCT00896038|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|45 minutes after the beginning of alcohol script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||units on a scale||Standard Error|Mean
793196|NCT00896038|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|30 minutes after the beginning of alcohol script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||units on a scale||Standard Error|Mean
793197|NCT00896038|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes after the beginning of alcohol script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||units on a scale||Standard Error|Mean
793198|NCT00896038|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|5 minutes after the beginning of alcohol script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||units on a scale||Standard Error|Mean
793199|NCT00896038|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes prior to the beginning of alcohol script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||units on a scale||Standard Error|Mean
793200|NCT00896038|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|90 minutes after the beginning of stress script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||units on a scale||Standard Error|Mean
793201|NCT00896038|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|75 minutes after the beginning of stress script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||units on a scale||Standard Error|Mean
793202|NCT00896038|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|60 minutes after the beginning of stress script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||units on a scale||Standard Error|Mean
793203|NCT00896038|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|45 minutes after the beginning of stress script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||units on a scale||Standard Error|Mean
793204|NCT00896038|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|30 minutes after the beginning of stress script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||units on a scale||Standard Error|Mean
793205|NCT00896038|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes after the beginning of stress script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||units on a scale||Standard Error|Mean
793206|NCT00896038|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|5 minutes after the beginning of stress script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||units on a scale||Standard Error|Mean
793207|NCT00896038|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes prior to the beginning of stress script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||units on a scale||Standard Error|Mean
793208|NCT00896051|Secondary|Time to Virologic Failure|The table below shows the number of days to virologic failure defined as a plasma viral load (VL) > 50 copies/mL for participants who had been virologic responders (ie, having a plasma VL <50, and <400 copies/mL according to the time to loss of virologic response [TLOVR] imputation method). Time to virologic failure was the time to subsequent loss of virologic response, and the time was calculated from Prebaseline (Week -2). Participants who never achieved a virologic response were defined as nonresponders and counted as virologic failures on Day 1.|Prebaseline to Week 48|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population).||Days||95% Confidence Interval|Median
793209|NCT00896051|Secondary|Time to Confirmed Virologic Response|The table below provides the time in days it took participants to reach a confirmed virologic response defined as a plasma viral load (VL) <50 copies/mL, and plasma VL <400 copies/mL analyzed according to the Time to Loss of Virologic Response (TLOVR) imputation method.|Prebaseline to Week 48|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population).||Days||95% Confidence Interval|Median
793210|NCT00896051|Secondary|Change From Pre-Baseline in Log10 Viral Load Over Time|The table below shows the mean change from prebaseline over time in log10 (Copies/mL) plasma viral load using the Non-Completing = Failure (NC=F) imputation method.|Pre-Baseline, Baseline, Weeks 4, 12, 24, 48|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population).||log10 (Copies/mL)||Standard Error|Mean
793211|NCT00896051|Secondary|The Percentage of Participants With a Virologic Response (Plasma Viral Load < 50 Copies/mL) at Week 48 Using the Snapshot Analysis Method|The table below provides the results from the snapshot analysis method that includes the percentage of participants with virologic response (<50 copies/mL), the percentage of participants who were virologic failures (VF) (>50 copies/mL, discontinued prior to time X for reasons of VF or for other reasons, except for VF or adverse event, with a last viral load >50 copies/mL), and the percentage of participants with no viral load (VL) data available at Week 48.|Week 48|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population).||Percentage of Participants|||Number
793212|NCT00896051|Secondary|The Percentage of Participants With a Virologic Response Using the Time to Loss of Virologic Response (TLOVR) Imputation Method|The table below shows the percentage of participants with a virologic response defined as a viral load <50 Copies/mL and <400 Copies/mL per time point calculated using the time to loss of virologic response (TLOVR) imputation method.|Baseline, Weeks 4, 12, 24, 48|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population).||Percentage of Particpants|||Number
793213|NCT00896051|Secondary|The Percentage of Participants With a Virologic Response Using the Non-Completing = Failure (NC=F) Imputation Method|The table below shows the percentage of participants per time point with a virologic response defined as having a plasma viral load (VL) <50 copies/mL, and with plasma VL <400 copies/mL using the Non-Completing = Failure (NC=F) imputation method (ie, participants who discontinued early were counted as nonresponders by having their VL values after discontinuation imputed with their Baseline value, thus resulting in a 0 change).|Baseline, Weeks 4, 12, 24, 48|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population).||Percentage of Participants|||Number
793214|NCT00896051|Secondary|Change From Prebaseline in CD4+ Cell Count Over Time|The table below shows the mean change from prebaseline over time in CD4+ cell count using the Non-Completing = Failure (NC=F) imputation method.|Prebaseline, Baseline, Weeks 4, 12, 24, 48|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population).||CD4+ cell count||Standard Error|Mean
793425|NCT00904371|Secondary|Pecentage of Patients That Achieved Target Blood Pressure (BP) Values According to ESH/ESC|ESH/ESC a goal of treatment to be below values 130/80 mm/Hg for diabetic patients and below 140/90 mmHg for non-diabetic patients|3rd visit (4-10 months)|Patients with data at 3rd visit (4-10 months)||Percentage of participants|||Number
793215|NCT00896051|Primary|Percentage of Participants With Undetectable Plasma Viral Load (VL) Values (<50 Copies/mL) at Week 48|The table below shows the percentage of participants wih undetectable plasma viral load (VL) values (<50 copies/mL) at Week 48 using the Non-Completing = Failure (NC=F) imputation method (ie, participants who discontinued early were counted as nonresponders by having their VL values after discontinuation imputed with their baseline value, thus resulting in a 0 change).|Week 48|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population).||Percentage of Participants||95% Confidence Interval|Number
793216|NCT00896051|Primary|Pharmacokinetic Results of Etravirine (ETR) (Results for AUC12hr)|The table below shows pharmacokinetic (PK) results of ETR in the current study expressed as the area under the plasma concentration-time curve from time of intake to 12 hours after dosing (AUC12hr).|Week 2|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population) for which data was available for the parameter reported.||ng.h/mL||Standard Deviation|Mean
793217|NCT00896051|Primary|Pharmacokinetic Results of Etravirine (ETR) (Results for C0h, Cmin, and Cmax)|The table below shows pharmacokinetic (PK) results of ETR in the current study expressed as the predose plasma concentration (C0h), minimum plasma concentration (Cmin) and maximum plasma concentration (Cmax).|Week 2|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population) for which data was available for the parameter reported.||ng/ml||Standard Deviation|Mean
793218|NCT00896051|Primary|Pharmacokinetic Results of Low-Dose Ritonavir (Rtv): Treatment B: Atazanavir (ATV)/Rtv 400/100 mg (Results for AUC24hr)|The table below shows pharmacokinetic (PK) results of low-dose ritonavir (rtv) when administered as atazanavir (ATV)/ritonavir (rtv) 300/100 mg pretreatment (Reference) and when administered as ATV/rtv 400/100 mg at Week 2 after treatment (Test). Results are expressed as the area under the plasma concentration-time curve from time of intake to 24 hours after dosing (AUC24hr).|Day -1 (Reference); Week 2 (Test)|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population) for which data was available for the parameter reported.||ng.h/ml||Standard Deviation|Mean
793219|NCT00896051|Primary|Pharmacokinetic Results of Low-Dose Ritonavir (Rtv): Treatment B: Atazanavir (ATV)/Rtv 400/100 mg (Results for C0h, Cmin, and Cmax)|The table below shows pharmacokinetic (PK) results of low-dose ritonavir (rtv) when administered as atazanavir (ATV)/ritonavir (rtv) 300/100 mg pretreatment (Reference) and when administered as ATV/rtv 400/100 mg at Week 2 after treatment (Test). Results are expressed as the predose plasma concentration (C0h), minimum plasma concentration (Cmin), maximum plasma concentration (Cmax), and area under the plasma concentration-time curve from time of intake to 24 hours after dosing (AUC24hr).|Day -1 (Reference); Week 2 (Test)|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population) for which data was available for the parameter reported.||ng/ml||Standard Deviation|Mean
793220|NCT00896051|Primary|Pharmacokinetic Results of Low-Dose Ritonavir (Rtv): Treatment A: Atazanavir (ATV)/Rtv 300/100 mg (Results for AUC24hr)|The table below shows the pharmacokinetic (PK) results of low-dose ritonavir (rtv) when administered as atazanavir (ATV)/rtv 300/100 mg pretreatment (Reference) and at Week 2 after treatment (Test). Results are expressed as the area under the plasma concentration-time curve from time of intake to 24 hours after dosing (AUC24hr).|Day -1 (Reference); Week 2 (Test)|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population) for which data was available for the parameter reported.||ng.h/ml||Standard Deviation|Mean
793221|NCT00896051|Primary|Pharmacokinetic Results of Low-Dose Ritonavir (Rtv): Treatment A: Atazanavir (ATV)/Rtv 300/100 mg (Results for C0h, Cmin, and Cmax)|The table below shows the pharmacokinetic (PK) results of low-dose ritonavir (rtv) when administered as atazanavir (ATV)/rtv 300/100 mg pretreatment (Reference) and at Week 2 after treatment (Test). Results are expressed as the predose plasma concentration (C0h), minimum plasma concentration (Cmin), and maximum plasma concentration (Cmax).|Day -1 (Reference); Week 2 (Test)|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population) for which data was available for the parameter reported.||ng/ml||Standard Deviation|Mean
793222|NCT00896051|Primary|Pharmacokinetic Results of Atazanavir (ATV): Treatment B: ATV/Low-Dose Ritonavir (Rtv) 400/100 mg (Results for AUC24hr)|The table below shows pharmacokinetic (PK) results of atazanavir (ATV) when administered as ATV/ritonavir (rtv) 300/100 mg pretreatment (Reference) and when administered as ATV/rtv 400/100 mg at Week 2 after treatment (Test). Results are expressed as the area under the plasma concentration-time curve from time of intake to 24 hours after dosing (AUC24hr).|Day -1 (Reference); Week 2 (Test)|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population) for which data was available for the parameter reported.||ng.h/mL||Standard Deviation|Mean
793223|NCT00896051|Primary|Pharmacokinetic Results of Atazanavir (ATV): Treatment B: ATV/Low-Dose Ritonavir (Rtv) 400/100 mg (Results for C0h, Cmin, and Cmax)|The table below shows pharmacokinetic (PK) results of atazanavir (ATV) when administered as ATV/ritonavir (rtv) 300/100 mg pretreatment (Reference) and when administered as ATV/rtv 400/100 mg at Week 2 after treatment (Test). Results are expressed as the predose plasma concentration (C0h), minimum plasma concentration (Cmin), maximum plasma concentration (Cmax), and area under the plasma concentration-time curve from time of intake to 24 hours after dosing (AUC24hr).|Day -1 (Reference); Week 2 (Test)|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population).||ng/ml||Standard Deviation|Mean
793224|NCT00896051|Primary|Pharmacokinetic Results of Atazanavir (ATV): Treatment A: ATV/Low-Dose Ritonavir (Rtv) 300/100 mg (Results for AUC24hr)|The table below shows pharmacokinetic (PK) results of atazanavir (ATZ) when administered as ATV/rtv 300/100 mg pretreatment (Reference) and at Week 2 after treatment (Test). Results are expressed as the area under the plasma concentration-time curve from time of intake to 24 hours after dosing (AUC24hr).|Day -1 (Pretreatment); Week 2 (Test)|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population) for which data was available for the PK parameter reported.||ng.h/mL||Standard Deviation|Mean
793225|NCT00896051|Primary|Pharmacokinetic Results of Atazanavir (ATV): Treatment A: ATV/Low-Dose Ritonavir (Rtv) 300/100 mg (Results for C0h, Cmin, and Cmax)|The table below shows pharmacokinetic (PK) results of atazanavir (ATZ) when administered as ATV/rtv 300/100 mg pretreatment (Reference) and at Week 2 after treatment (Test). Results are expressed as the predose plasma concentration (C0h), minimum plasma concentration (Cmin), and maximum plasma concentration (Cmax).|Day -1 (Pretreatment); Week 2 (Test)|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population) for which data was available for the PK parameter reported.||ng/ml||Standard Deviation|Mean
793226|NCT00896064|Secondary|Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities|Among haematological or biochemical abnormalities assessed were: Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Cholesterol, Creatine Phosphokinase (CRP), Hemoglobin decrease, Haemoglobin, Lactate dehydrogenase (LDH), Neutrophils, Red blood cells (RBC), Reticulocytes, White blood cells (WBC) and Overall parameters. Note: Blood samples were collected at Days 1 and 6.|At 1 and 7 days post-booster vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccine administration documented.||Participants|||Count of Participants
793227|NCT00896064|Secondary|Number of Subjects With Any SAEs|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Day 0 to Day 30)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccine administration documented.||Participants|||Count of Participants
793228|NCT00896064|Secondary|Number of Subjects With Any Unsolicited AEs|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Days 0-30) post-booster vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccine administration documented.||Participants|||Count of Participants
793229|NCT00896064|Secondary|Number of Subjects With Any Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (nausea, vomiting, diarrhoea and/or abdominal pain), headache, malaise, myalgia and fever [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade.|During the 7-day (Days 0-6) post-booster vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccine administration documented.||Participants|||Count of Participants
793230|NCT00896064|Secondary|Number of Subjects With Any Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.|During the 7-day (Days 0-6) post-booster vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccine administration documented.||Participants|||Count of Participants
793231|NCT00896064|Secondary|Titers for Antibodies Against Pneumolysin Haemolysis (Hem-dPly) Protein|Antibody titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 6.|Prior to the booster vaccination (Day 0) and one month post-booster vaccination (Day 30)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom post results were available for at least one assay.||Titers||95% Confidence Interval|Geometric Mean
793232|NCT00896064|Secondary|Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (dPly) and Histidine Triad Protein D (PhtD) Proteins|Anti-dPly and anti-PhtD antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in LU/mL. The reference seropositivity cut-off values were equal to or above (≥) 599 LU/mL for anti-dPly and ≥ 391 LU/mL for anti-PhtD.|Prior to the booster vaccination (Day 0) and one month post-booster vaccination (Day 30)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom post results were available for at least one assay.||LU/mL||95% Confidence Interval|Geometric Mean
793233|NCT00896064|Primary|Number of Subjects With Grade 3 Haematological or Biochemical Abnormalities|"Among haematological or biochemical abnormalities assessed were: Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Cholesterol, Creatine Phosphokinase (CRP), Hemoglobin decrease, Haemoglobin, Lactate dehydrogenase (LDH), Neutrophils, Red blood cells (RBC), Reticulocytes, White blood cells (WBC) and Overall parameters.
Note: Blood samples were collected at Days 1 and 6."|At Days 1 and 7 post-booster vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccine administration documented.||Participants|||Count of Participants
793234|NCT00896064|Primary|Number of Subjects With Any Vaccine-related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Day 0 to Day 30)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccine administration documented.||Participants|||Count of Participants
793235|NCT00896064|Primary|Number of Subjects With Grade 3 and Vaccine-related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 31-day (Days 0-30) post-booster vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccine administration documented.||Participants|||Count of Participants
793259|NCT00902174|Secondary|Change From Baseline in Heart Rate|Change from baseline in heart rate (bpm) was measured via right heart catheterization according to the local hospital procedures. The heart rate was assessed when the participant was in a stable hemodynamic rest state.|24 weeks|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.||bpm||Standard Error|Least Squares Mean
793236|NCT00896064|Primary|Number of Subjects With Grade 3 and Vaccine-related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (nausea, vomiting, diarrhoea and/or abdominal pain), headache, malaise, myalgia and fever [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = general symptom assessed by the investigator to be casually related to the study vaccination.|During the 7-day (Days 0-6) post-booster vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccine administration documented.||Participants|||Count of Participants
793237|NCT00896064|Primary|Number of Subjects With Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Grade 3 pain = significant pain at rest, pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.|During the 7-day (Days 0-6) post-booster vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccine administration documented.||Participants|||Count of Participants
793238|NCT00896168|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 26|ESR is also called a sedimentation rate or Westergren ESR, is the rate at which red blood cells sediment in a period of 1 hour. It is a common hematology test, and is a non-specific measure of inflammation.|Baseline and Week 26|FAS population included participants who received at least 1 dose of study medication and possessed the record of efficacy data.||Millimeter/1 hour||Standard Deviation|Mean
793239|NCT00896168|Secondary|Change From Baseline in C-Reactive Protein (CRP) at Week 26|CRP is a protein found in the blood, the levels of which rise in response to inflammation.|Baseline and Week 26|FAS population included participants who received at least 1 dose of study medication and possessed the record of efficacy data. Here, 'N' signifies participants who were evaluated for this outcome measure.||Milligram/Liter||Standard Deviation|Mean
793240|NCT00896168|Secondary|Change From Baseline in Health Assessment Questionnaire (HAQ) at Week 26|The HAQ, a 20-question instrument, assesses the degree of difficulty a person has in accomplishing tasks in eight functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores). Responses in each area are scored from 0=no difficulty to 3=inability to perform a task in that area.|Baseline and Week 26|FAS population included participants who received at least 1 dose of study medication and possessed the record of efficacy data.||Units on a scale||Standard Deviation|Mean
793241|NCT00896168|Secondary|Change From Baseline in Duration of Morning Stiffness at Week 26|Duration of morning stiffness: Time elapsed in minutes when participant woke up in morning and was able to resume normal activities without stiffness. Increase in stiffness duration from Baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Baseline and Week 26|FAS population included participants who received at least 1 dose of study medication and possessed the record of efficacy data.||Minutes||Standard Deviation|Mean
793242|NCT00896168|Secondary|Change From Baseline in Physicians' Global Disease Assessment at Week 26|Physicians scored the overall disease state using VAS of 0-100 mm. Physicians might have assessed the activity of RA using “0=no active RA” to “100=most serious active RA” scale.|Baseline and Week 26|FAS population included participants who received at least 1 dose of study medication and possessed the record of efficacy data.||Units on a scale||Standard Deviation|Mean
793243|NCT00896168|Secondary|Change From Baseline in Participants' Global Disease Assessment at Week 26|"Participants scored the overall disease state using VAS of 0-100 mm. Participants might have assessed the Control of their current disease using “0 mm=very good” to “100 mm=very poor scale."|Baseline and Week 26|The FAS population included participants who received at least 1 dose of study medication and had post efficacy data.||Units on a scale||Standard Deviation|Mean
793244|NCT00896168|Secondary|Change From Baseline in Participant’s Pain Visual Analogue Scale (VAS) Score at Week 26|Participant’s pain was assessed on VAS of 0 to 100 mm (0=not at all to 100=extreme pain).|Baseline and Week 26|The FAS population included participants who received at least 1 dose of study medication and had post efficacy data.||Units on a scale||Standard Deviation|Mean
793245|NCT00896168|Secondary|Change From Baseline in Tender Joints Count at Week 26|Number of tender joints was determined by examination of 28 joints and identifying when tenderness is present. The number of tender joints was recorded on the joint assessment form at each visit; the tenderness of symptomatic joints was graded on a scale ranging from 0-3 (0=no pain, 1=mild, 2= moderate and 3=severe).|Baseline and Week 26|The FAS population included participants who received at least 1 dose of study medication and had post efficacy data.||Tender joints||Standard Deviation|Mean
793246|NCT00896168|Secondary|Change From Baseline in Swollen Joints Count at Week 26|Number of swollen joints were determined by examination of 28 joints and identifying when swelling is present. The number of swollen joints was recorded on the joint assessment form at each visit; the swelling was graded on a scale ranging from 0-2 (0=no swelling, 1=swelling, but bony landmarks seen, 2=swelling but bone marks not seen). Participants categorized as Hepatitis B Virus antigen (HBsAb) positive/negative (at least 1 of HbsAg, HBeAg, Anti-HbeAg and Anti-HbcAg were positive or all were negative).|Baseline and Week 26|The FAS population included participants who received at least 1 dose of study medication and had post efficacy data.||Swollen joints||Standard Deviation|Mean
793247|NCT00896168|Primary|Percentage of Participants Achieving American College of Rheumatology Score 70 Percent (ACR70) Response|ACR70 is achieved if the participant has 70% improvement from Baseline in swollen joint count; tender joint count and in at least 3 of the following 5 assessments: participants’ assessment of pain; participants’ global assessment of disease activity; physician’s global assessment of disease activity; participants’ assessment of physical function (Health Assessment Questionnaire [HAQ]) and C-reactive protein (CRP).|Week 26|The FAS population included participants who received at least 1 dose of study medication and had post efficacy data.||Percentage of participants|||Number
793248|NCT00896168|Primary|Percentage of Participants Achieving American College of Rheumatology Score 50 Percent (ACR50) Response|ACR50 is achieved if the participant has 50% improvement from Baseline in swollen joint count; tender joint count and in at least 3 of the following 5 assessments: participants’ assessment of pain; participants’ global assessment of disease activity; physician’s global assessment of disease activity; participants’ assessment of physical function (Health Assessment Questionnaire [HAQ]) and C-reactive protein (CRP).|Week 26|The FAS population included participants who received at least 1 dose of study medication and had post efficacy data.||Percentage of participants|||Number
793249|NCT00896168|Primary|Percentage of Participants Achieving American College of Rheumatology Score 20 Percent (ACR20) Response|ACR20 is achieved if the participant has 20% improvement from Baseline in swollen joint count; tender joint count and in at least 3 of the following 5 assessments: participants’ assessment of pain; participants’ global assessment of disease activity; physician’s global assessment of disease activity; participants’ assessment of physical function (Health Assessment Questionnaire [HAQ]) and C-reactive protein (CRP).|Week 26|Full analysis set (FAS) included participants who received at least 1 dose of study medication and had post efficacy data.||Percentage of participants|||Number
793250|NCT00902161|Secondary|Number of Participants Who Discontinued Study Treatment Due To AEs|"An AE was defined as any unfavorable and unintended change in the
structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. This also included any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor's product."|From time of first administration of study treatment to time of last administration of study treatment (up to Day 21)|All treated participants||participants|||Number
793251|NCT00902161|Secondary|Number of Participants With An Adverse Event (AE)|"An AE was defined as any unfavorable and unintended change in the
structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. This also included any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor's product."|From time of administration of study treatment through end of Post-Study (up to 21 days after administration of last dose of study treatment).|All treated participants||participants|||Number
793252|NCT00902161|Secondary|Plasma Concentration at 32 Hours (C[32hr]) Post Single Dose MK0893|Plasma concentration of single dose MK0893 was measured from time of administration to 24 hours post-dose and extrapolated out to 32 hours post-dose using the plasma concentration vs. time curve|From time of MK0893 administration through estimated 32 hours post-dose|Data from the first 15 participants who completed the study were used for the pharmacokinetic analysis.||nM||Standard Deviation|Mean
793253|NCT00902161|Secondary|Maximum Plasma Concentration (Cmax) and Concentration Average Over 8-12 Hours (C[Ave] 8-12 hr) Post Single Dose MK0893|"Cmax was the maximum or “peak” concentration of MK0893 observed after its administration.
Approximate C(ave 8-12) was the MK0893 concentration average over 8-12 hours post-dose and was computed as the Area Under the Curve over 8-12 hours post-dose (AUC [8-12]) ÷ 4"|From time of MK0893 administration through 24 hours post-dose|Data from the first 15 participants who completed the study were used for the pharmacokinetic analysis.||uM||Standard Deviation|Mean
793254|NCT00902161|Primary|Recovery Time (Rt[65] From Insulin-induced Hypoglycemia|Rt(65) defined as the time to recover from hypoglycemia (blood glucose level of 50 mg/dL) to an arterialized venous blood glucose of 65 mg/dL. At t= -60 minutes on the morning of Day 1 (Visit 6) or Day 22 (Visit 8), a hypoglycemic clamp was used via an increased insulin infusion rate to achieve blood glucose concentrations of 50 mg/dL (2.8 mmol/L) within ~30-90 minutes. At the end of the 30-minute hypoglycemic clamp interval, insulin and glucose infusions were terminated, and the time to recover from hypoglycemia to 65 mg/dL Rt(65) was determined. Rt(65) was followed up to 270 minutes|From the time of hypoglycemic clamp (t=0 minutes) through 270 minutes|21 participants who received MK0893 + Propanolol while on study had data available, and 17 participants who received Placebo + Propanolol while on study had data available||minutes||95% Confidence Interval|Least Squares Mean
793255|NCT00902174|Secondary|Plasma Concentration of QTI571 400 mg and Its Metabolite (GCP74588) Pre-dose and Between 0 Hour to 3 Hour Post-dose Per Participant|"Blood samples were taken from each subject participating in the study (placebo group and active treatment group) once predose and once between 0 hour to 3 hour post dose at day 1 (baseline), day 14, day 28 and day 168.
The parent compound QTI571 and its active metabolite, GCP74588, were measured in plasma by validated liquid chromatography-mass spectrometry (HPLC-MS/MS) assay."|predose and between 0 hour to 3 hour post dose at day 1, day 14, day 28 and day 168|The Full Analysis Set includes all patients who received at least one dose of study drug with available blood samples for analysis.||ng/mL||Standard Deviation|Mean
793256|NCT00902174|Secondary|Plasma Concentration of QTI571 200 mg and Its Metabolite (GCP74588) Pre-dose and Between 0 Hour to 3 Hour Post-dose Per Participant|"Blood samples were taken from each subject participating in the study (placebo group and active treatment group) once predose and once between 0 hour to 3 hour post dose at day 1 (baseline), day 14, day 28 and day 168.
The parent compound QTI571 and its active metabolite, GCP74588, were measured in plasma by validated liquid chromatography-mass spectrometry (HPLC-MS/MS) assay."|predose and between 0 hour to 3 hour post dose at day 1, day 14, day 28 and day 168|The Full Analysis Set includes all patients who received at least one dose of study drug with available blood samples for analysis.||ng/mL||Standard Deviation|Mean
793257|NCT00902174|Secondary|Covariance of End of Study CAMPHOR Score|The CAMPHOR test consists of 65 items and 3 scales. Two scales measure Health Related Quality of Life. 1) Symptoms: consists of 25 items measuring loss or abnormality of psychological, physiological or anatomical structure or function; further sub-divided into 3 subscales (energy, breathlessness and mood), 2) Disability: consists of 15 items measuring any restriction or lack of ability to perform an activity. 3) Quality of Life (QOL): consists of 25 items defining how individuals perceived ability and capacity to satisfy their needs. The 25-item symptom and QOL scales score from 0-25 where a higher score indicates the presence of more symptoms and poor QOL, respectively. The 15-item functioning scale scores 0-30; a higher score indicates poor functioning.|Week 24|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.||units on a scale||Standard Error|Least Squares Mean
793258|NCT00902174|Secondary|Change in Borg Dyspnea Score During 6-minute Walk Test|Change in Borg scale was measured at different time points at week 24. The Borg Scale consists of scale range of 0 to 10. Participants pointed to indicate their level of dyspnea before and at the end of exercise testing (where 0 indicates no breathlessness at all and 10 indicates maximum breathlessness). A reduction in this score indicates an improvement.|week 24|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.||units on a scale||Standard Deviation|Mean
793260|NCT00902174|Secondary|Change From Baseline in Diastolic Arterial Blood Pressure|Change from baseline in diastolic arterial blood pressure (mmHg) was measured via right heart catheterization according to the local hospital procedures. The diastolic arterial blood pressure was assessed when the participant was in a stable hemodynamic rest state.|baseline and week 24|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.||mm Hg||Standard Error|Least Squares Mean
793261|NCT00902174|Secondary|Change From Baseline in Systolic Arterial Blood Pressure|Change from baseline in systolic arterial blood pressure (mmHg) was measured via right heart catheterization according to the local hospital procedures. The systolic arterial blood was assessed when the participant was in a stable hemodynamic rest state.|baseline and week 24|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.||mm Hg||Standard Error|Least Squares Mean
793262|NCT00902174|Secondary|Change From Baseline in Cardiac Output|Change from baseline in cardiac output (L/min) was measured via right heart catheterization according to the local hospital procedures. The cardiac output was assessed when the participant was in a stable hemodynamic rest state. An increase from baseline (higher number) in cardiac output indicates improvement.|24 weeks|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.||Liters/minute||Standard Error|Least Squares Mean
793263|NCT00902174|Secondary|Change From Baseline in Pulmonary Resistance Index|Change from baseline in pulmonary resistance index (dynes*sec*cm^-5/m2) was measured via right heart catheterization according to the local hospital procedures. The pulmonary resistance index was assessed when the participant was in a stable hemodynamic rest state. A reduction from baseline in pulmonary resistance index indicates improvement.|baseline and week 24|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.||dynes*sec*cm^-5/m2||Standard Error|Least Squares Mean
793264|NCT00902174|Secondary|Change From Baseline in Pulmonary Vascular Resistance|Change from baseline in pulmonary vascular resistance (dynes*sec*cm^-5) was measured via right heart catheterization according to the local hospital procedures. The pulmonary vascular resistance was assessed when the participant was in a stable hemodynamic rest state. Reduction from baseline in pulmonary vascular resistance indicates improvement.|baseline and week 24|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.||dynes*sec*cm^-5||Standard Error|Least Squares Mean
793265|NCT00902174|Secondary|Change From Baseline in Systemic Vascular Resistance|Change from baseline in systemic vascular resistance (dynes*sec*cm^-5) was measured via right heart catheterization according to the local hospital procedures. The systemic vascular resistance was assessed when the participant was in a stable hemodynamic rest state. Reduction from baseline in mean systemic vascular resistance indicates improvement.|baseline and week 24|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.||dynes*sec*cm^-5||Standard Error|Least Squares Mean
793266|NCT00902174|Secondary|Change From Baseline in Mean Pulmonary Capillary Wedge Pressure|Change from baseline in mean pulmonary capillary wedge pressure (mmHg)was measured via right heart catheterization according to the local hospital procedures. The right atrial mean pulmonary capillary wedge pressure was assessed when the participant was in a stable hemodynamic rest state.|baseline and week 24|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.||mm Hg||Standard Error|Least Squares Mean
793267|NCT00902174|Secondary|Change From Baseline in Mean Pulmonary Arterial Pressure|Change from baseline in mean pulmonary arterial pressure (mmHg) was measured via right heart catheterization according to the local hospital procedures. The mean pulmonary arterial pressure was assessed when the participant was in a stable hemodynamic rest state. A higher mean pulmonary arterial pressure number indicates worsening.|baseline and week 24|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis||mm Hg||Standard Error|Least Squares Mean
793268|NCT00902174|Secondary|Change From Baseline in Right Atrial Pressure|Change from baseline in right atrial pressure (mmHg) was measured via right heart catheterization according to the local hospital procedures. The right atrial pressure was assessed when the participant was in a stable hemodynamic rest state. A higher right atrial pressure number indicates worsening.|baseline and week 24|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.||mm Hg||Standard Error|Least Squares Mean
793269|NCT00902174|Secondary|Clinical Worsening Comparing Imatinib Versus Placebo for Adjudicated Cases|Clinical worsening per participant was measured by the onset of any adjudicated event (all cause mortality; overnight hospitalization for worsening of Pulmonary Arterial Hypertension (PAH); worsening of WHO functional class by one level; 15% decline in Six Minute Walk Distance (6MWD) measured on two consecutive occasions) at 24 weeks treatment, comparing imatinib to placebo groups. A cox regression analysis model was used.|24 weeks|The Full Analysis Set included all participants who received at least one dose of study drug and experienced an adjudicated event. A cox regression analysis model was used.||percentage of participants|||Number
793270|NCT00902174|Primary|Difference in Six-minute Walk Distance Test (6MWD) Between Imatinib and Placebo at 24 Weeks|This standardized walk course was 30 meters in length. During the walk the participant was connected to a portable pulse oximeter via a finger probe. Participants were instructed to walk at a comfortable speed for as far as they could manage in 6 minutes. The total distance walked (in meters) was recorded. Results were compared between the 2 groups.|24 weeks|The Full Analysis Set includes all participants who received at least one dose of study drug and completed the 6MWD Six-minute walk test at week 24. Repeated measurement model was used for this analysis.||meters||Standard Error|Least Squares Mean
793271|NCT00902226|Secondary|Effect of Escitalopram After 12 Weeks Using Sheehan Disability Scale (SDS) Social|The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment.|baseline and 12 weeks|||scores on a scale||Standard Deviation|Mean
793272|NCT00902226|Secondary|Effect of Escitalopram After 12 Weeks Using Sheehan Disability Scale (SDS) Family|The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment.|baseline and 12 weeks|||scores on a scale||Standard Deviation|Mean
793273|NCT00902226|Secondary|Effect of Escitalopram After 12 Weeks Using Sheehan Disability Scale (SDS) Work|The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment.|baseline and 12 weeks|Due to data being unavailable, 22 participants were analysed for this outcome, in contrast with 30 participants for the other outcomes.||scores on a scale||Standard Deviation|Mean
793274|NCT00902226|Secondary|Percentage of Patients Who Achieved Remission After 12 Weeks of Treatment Using CGI-S <= 2|The CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients).|baseline and 12 weeks|||percentage of patients|||Number
793275|NCT00902226|Secondary|Percentage of Patients Who Responded to Escitalopram After 12 Weeks of Treatment Using CGI-I <= 2|The CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).|baseline and 12 weeks|||percentage of patients|||Number
793276|NCT00902226|Secondary|Effect of Escitalopram After 12 Weeks Using the Clinical Global Impression (CGI-S)|The CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients).|baseline and 12 weeks|||scores on a scale||Standard Deviation|Mean
793277|NCT00902226|Primary|Effect of Escitalopram After 12 Weeks Using the Clinical Global Impression (CGI-I)|The CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).|baseline and 12 weeks|||scores on a scale||Standard Deviation|Mean
793278|NCT00902265|Secondary|Participants With Treatment Emergent Adverse Events (AEs)||Week 1 to Week 12|Safety Population, consisting of participants who took at least one dose of desmopressin||Participants|||Number
793279|NCT00902265|Secondary|Change From Baseline in Degree of Bother Due to Frequency of Nighttime Voiding Assessed by The International Consultation on Incontinence Modular Questionnaire - Nocturia (ICIQ-N)at Week 12|The ICIQ-N is a self-administered 4-item questionnaire designed to assess the frequency and bother of daytime and nighttime urination. In questions 3 and 4, participants were asked to estimate the frequency of nighttime voiding (number of voids after going to bed plus the first morning void) and rate the degree of bother of nighttime urination on a scale ranging from 0 (not at all) to 10 (a great deal). Higher numbers indicate lower Quality of Life (QOL).|Baseline, Week 12|Intent to treat (ITT) population --All participants who received at least one dose of study drug and provided at least one primary efficacy measure (i.e., number of nocturnal voids).||Units on a scale||Standard Deviation|Mean
793280|NCT00902265|Secondary|Change From Baseline in Degree of Bother Due to Frequency of Daytime Voiding Assessed by The International Consultation on Incontinence Modular Questionnaire - Nocturia (ICIQ-N)|The ICIQ-N is a self-administered 4-item questionnaire designed to assess the frequency and bother of daytime and nighttime urination. In questions 1 and 2 participants were asked to estimate the frequency of both daytime voiding (all voids before going to bed excluding the first morning void) and rate the degree of bother of daytime urination on a scale ranging from 0 (not at all) to 10 (a great deal). Higher numbers indicate lower Quality of Life (QoL).|Baseline, Week 12|Intent to treat (ITT) population --All participants who received at least one dose of study drug and provided at least one primary efficacy measure (i.e., number of nocturnal voids).||Units on a scale||Standard Deviation|Mean
793281|NCT00902265|Secondary|Mean Change From Baseline in Total Score in Leeds Sleep Evaluation Questionnaire (LSEQ) at Week 12|The LSEQ is a self-administered 10-item visual analog scale questionnaire designed to assess sleep quality. The 10 individual items are scored 1 to 100, with the total score ranging from 0 - 1,000. Higher numbers indicate lower sleep quality.|Baseline, Week 12|Intent to treat (ITT) population --All participants who received at least one dose of study drug and provided at least one primary efficacy measure (i.e., number of nocturnal voids).||Units on a scale||Standard Deviation|Mean
793282|NCT00902265|Secondary|Mean Change From Baseline International Prostate Symptom Score (IPSS) Quality of Life Score at Week 12|The International Prostate Symptoms Score (IPSS) is a self-administered 8 item questionnaire designed to assess urination frequency and Quality of Life (QOL). The last question (item 8) concerns Quality of Life (QOL) and is scaled 0-6 where higher numbers indicate lower quality of life due to symptoms. Higher scores represent worse Quality of Life (QoL).|Baseline, Week 12|Intent to treat (ITT) population --All participants who received at least one dose of study drug and provided at least one primary efficacy measure (i.e., number of nocturnal voids).||Units on a scale||Standard Deviation|Mean
793283|NCT00902265|Secondary|Mean Change From Baseline of Total International Prostate Symptom Score (IPSS) at Week 12|The International Prostate Symptoms Score (IPSS) is a self-administered 8 item questionnaire designed to assess urination frequency and Quality of Life (QOL). The first 7 items are summed into a total score and question urination frequency. They are scaled 0-5, with higher numbers indicating greater severity of symptoms. The last question (item 8) concerns QOL and is scaled 0-6 where higher numbers indicate lower quality of life due to symptoms. The total scale across all questions is 0-41, with higher scores representing worse symptoms.|Baseline, Week 12|Intent to treat (ITT) population --All participants who received at least one dose of study drug and provided at least one primary efficacy measure (i.e., number of nocturnal voids)||Units on a scale||Standard Deviation|Mean
793426|NCT00904371|Primary|Change From Baseline in Risk Assessment According to ESH/ESC Guidelines|ESH is the European society of hypertension, and ESC is the European society of cardiology.|Baseline to 3rd visit (4-10 months)|Patients with data both at baseline and on 3rd visit (4-10 months)||Participants moved into category|||Number
793284|NCT00902265|Secondary|Mean Change From Baseline in Initial Period of Undisturbed Sleep at Week 12|Initial period of undisturbed sleep is calculated as the number of hours between falling asleep and waking for the first time during the night to void. Change is calculated at Week 12 – baseline.|Baseline, Week 12|Intent to treat (ITT) population --All participants who received at least one dose of study drug and provided at least one primary efficacy measure (i.e., number of nocturnal voids)||Hours||Standard Deviation|Mean
793285|NCT00902265|Secondary|Mean Change From Baseline in Ratio of Nighttime Urine Volume to 24-hour Urine Volume at Week 12|The ratio of nighttime urine volume to 24-hour urine volume is calculated as the urine volume (volume of all voids after going to bed plus the first morning void) / 24-hour urine volume. Ratios are calculated at baseline and week 12 and difference between the two time points is reported here.|Baseline, Week 12|Intent to treat (ITT) population --All participants who received at least one dose of study drug and provided at least one primary efficacy measure (i.e., number of nocturnal voids)||ratio||Standard Deviation|Mean
793286|NCT00902265|Primary|Overall Mean Change From Baseline in Mean Number of Nighttime Voids at Week 12|The number of nighttime voids was calculated over 48-hours period prior to baseline and week 12 visits. Calculated as Week 12 measure - Baseline measure.|Baseline, Week 12|Intent to treat (ITT) population --All participants who received at least one dose of study drug and provided at least one primary efficacy measure (i.e., number of nocturnal voids)||Number of nocturnal voids||Standard Deviation|Mean
793287|NCT00902668|Primary|Proportion of Good/Excellent Cosmetic Outcome During the First 5 Years After Radiotherapy|Proportion of good or excellent cosmetic outcomes, assessed using the Harvard Cosmesis Scale|during the first 5 years after treatment|Due to slow accrual the study was closed to accrual and all 3 participants were terminated. No data was analyzed.|||||
793288|NCT00902746|Secondary|Difference in the Visual Analog Scale (VAS) of Dysmenorrhea (Baseline/Pretreatment-dnd of Treatment)|VAS stands for Visual Analogue Scale of pain. The scale was rated as a graphic rating scale. as a 100mm baseline from 0:No pain to 100:Worst possible pain.|52 weeks|This analysis was carried out for 112 patients whom end of study data was available on FAS.||units on a scale||Standard Deviation|Mean
793289|NCT00902746|Primary|Patient Response to Treatment for Dysmenorrhea, as Evaluated by Difference of Total Dysmenorrhea Score (Baseline/Pretreatment-End of Treatment)|"The detail of dysmenorrhea score that was used in this study is the following. These subscales summed for a total dysmenorrhea score (minimum 0 to maximum 6). Pain score None 0 : None Mild 1 : There are some troubles for work Moderate 2 : Needing to rest in bed and/or affecting work Severe 3 : Morre than 1 day in bed and not possible to work
Drug score (during a menstrual period) None 0 : None Mild 1 : taking analgesics for 1 days Moderate 2 : taking analgesics for 2 days Severe 3 : taking analgesics more than 3 days"|52 weeks|This analysis was carried out for 112 patients whom end of study data was available on FAS.||units on a scale||Standard Deviation|Mean
793290|NCT00902850|Primary|Clinical Performance|Comfort of lens wear compared at insertion of lens, 4 hours after insertion, and end of day (8-16 hours of wear-time). Score was a number on a scale 0-100, graded by the participants, and included lens edge awareness, scratchiness/grittiness, foreign body sensation, and general lens awareness.|Insertion, 4 hours & End of Day|All eligible participants||units on a scale|||Number
793291|NCT00903006|Primary|Patient Response (+ Time to Disease Progression)||Baseline, after two 28 day cycles, until disease progression.||||||
793292|NCT00903006|Primary|Phase I Maximum Tolerated Dose (MTD) for Dose Level 1|"Maximum Tolerated Dose (MTD) defined as the dose or dose-combination that has the mean posterior toxicity rate closest to the target toxicity rate of 0.33. Dose levels reviewed with each 28 day cycle. Treatment dose levels:
Fulvestrant will be given using a loading dose of 500 mg intramuscularly (IM) on day 1 as two 250 mg/5 ml injections, followed by 500 mg IM on day 15 and on day 1 of each subsequent 28- day (+/- 2 days) cycle.
MK-0646 will be given intravenously on days 1,8, 15, and 22 for each cycle at one of the two dose levels: 1) 5 mg/kg or 2) 10 mg/kg (Dose level 1)
Dasatinib will be given orally (PO) continuously on days 1 -28 for each cycle at one of two dose levels: 1) 70 mg po daily or 2) 100 mg po daily"|28 day cycle|Study terminated early; Analysis not available due to smaller sample size.|||||
793293|NCT00903032|Primary|Adherence to Cardioprotective Medications (Clopidogrel, Statins, Beta Blockers, ACE-inhibitor/ARB)|The primary outcome was the proportion of patients who were adherent to cardioprotective medications (beta-blockers, statins, clopidogrel, and ACE/ARB) in the year following ACS hospitalization.|12-months|Composite Adherence* (PDC>0.80) (%)||percentage of participants|||Number
793294|NCT00903162|Secondary|The Effect of OFS Combined With Aromatase Inhibitor Therapy on the Incidence and Severity of Menopausal Symptoms, Sexual Dysfunction, Musculoskeletal Complaints, Other Side Effects and Overall Quality of Life.|OFS combined with aromatase inhibitor therapy on the incidence and severity of menopausal symptoms, sexual dysfunction, musculoskeletal complaints, other side effects and overall quality of life in this population.|2 years|This data was not collected nor analyzed because of too few participants to be meaningful.|||||
793295|NCT00903162|Secondary|Ovarian Function Suppression (OFS) Combined With Aromatase Inhibition Combined With Intravenous Bisphosphonate Therapy on Bone Mineral Density.|Ovarian function suppression (OFS) combined with aromatase inhibition combined with intravenous bisphosphonate therapy on bone mineral density in this patient population.|2 years|This data was not collected nor analyzed because of too few participants to be meaningful.|||||
793296|NCT00903162|Primary|Tolerability at One Year of Ovarian Function Suppression (OFS) Using Leuprolide and Letrozole.|The tolerability at one year of ovarian function suppression (OFS) using leuprolide and letrozole in this patient population. Specifically, the number of patients who discontinued treatment prior to one year due to toxicity.|1 year|Between September 15, 2009, and January 18, 2013, 17 patients were enrolled, but only 16 actually began protocol-directed treatment. Of the 16, 4 stopped treatment before completing even 1 year of protocol-directed therapy, owing to toxicity.||participants|||Number
793327|NCT00903383|Secondary|ACR50 Response at Week 12|Evaluates the efficacy of LX3305 by utilizing the American College of Rheumatology 50% response criteria (ACR50) at 12 weeks in subjects with active RA also receiving stable doses of MTX. For a response of ACR50, there had to be ≥50% improvement in swollen joint count, ≥50% improvement in painful/tender joint count, and ≥50% improvement in at least 3 of the following: subject's assessment of pain, global assessment of disease activity, assessment of physical function, or acute phase reactant (C-reactive protein or erythrocyte sedimentation rate).|Baseline and 12 weeks|Intent to Treat Population||Participants|||Number
793297|NCT00903175|Secondary|Time to Definitive Deterioration of the Fatigue Scale of the EORTC QLQ-C30 by First and Second-Line Drugs Combined|The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) contains 30 items. These include a global health status/QoL scale, five functional scales, three symptom scales, and six single items. The standardized score for the PF, fatigue subscales and global health status ranges from 0 to 100, with a higher score representing a high level of functioning/high level of symptom/high quality of life. Definitive deterioration by at least 10% was defined as a decrease in score by at least 10% compared to baseline, with no later increase above this threshold observed during the first line or second line treatment. A single measure reporting a decrease of at least 10% was considered definitive only if it was the last one available for the participant.|<=14 days prior to the first dose of study medication, on day 1, day 28 of every cycle, at the end of treatment visit, at the 28 day FUP visit and monthly thereafter for up to 3 months or until initiation of another anticancer therapy up to 35 months|The Full Analysis Set (FAS) consists of all randomized patients analyzed according to the treatment and stratum they were assigned to at randomization.||Months||95% Confidence Interval|Mean
793298|NCT00903175|Secondary|Time to Definitive Deterioration of the Fatigue Scale of the EORTC QLQ-C30 by First-Line Drug|The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) contains 30 items. These include a global health status/QoL scale, five functional scales, three symptom scales, and six single items.The standardized score for the PF, fatigue subscales and global health status ranges from 0 to 100, with a higher score representing a high level of functioning/high level of symptom/high quality of life. Definitive deterioration by at least 10% was defined as a decrease in score by at least 10% compared to baseline, with no later increase above this threshold observed during the first line of treatment. A single measure reporting a decrease of at least 10% was considered definitive only if it was the last one available for the participant.|<=14 days prior to the first dose of study medication, on day 1, day 28 of every cycle, at the end of treatment visit, at the 28 day FUP visit and monthly thereafter for up to 3 months or until initiation of another anticancer therapy up to 35 months|The Full Analysis Set (FAS) consists of all randomized patients analyzed according to the treatment and stratum they were assigned to at randomization.||Months||95% Confidence Interval|Median
793299|NCT00903175|Secondary|Time to Definitive Deterioration of the Global Health Status/QoL Scores of the EORTC QLQ-C30 by First and Second-Line Drugs Combined|The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) contains 30 items. These include a global health status/QoL scale, five functional scales, three symptom scales, and six single items. The standardized score for the PF, fatigue subscales and global health status ranges from 0 to 100, with a higher score representing a high level of functioning/high level of symptom/high quality of life. Definitive deterioration by at least 10% was defined as a decrease in score by at least 10% compared to baseline, with no later increase above this threshold observed during the first line or second line treatment. A single measure reporting a decrease of at least 10% was considered definitive only if it was the last one available for the participant.|<=14 days prior to the first dose of study medication, on day 1, day 28 of every cycle, at the end of treatment visit, at the 28 day FUP visit and monthly thereafter for up to 3 months or until initiation of another anticancer therapy up to 35 months|The Full Analysis Set (FAS) consists of all randomized patients analyzed according to the treatment and stratum they were assigned to at randomization.||Months||95% Confidence Interval|Median
793300|NCT00903175|Secondary|Time to Definitive Deterioration of the Global Health Status/QoL Scores of the EORTC QLQ-C30 by First-Line Drug|The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) contains 30 items. These include a global health status/QoL scale, five functional scales, three symptom scales, and six single items.The standardized score for the PF, fatigue subscales and global health status ranges from 0 to 100, with a higher score representing a high level of functioning/high level of symptom/high quality of life. Definitive deterioration by at least 10% was defined as a decrease in score by at least 10% compared to baseline, with no later increase above this threshold observed during the first line of treatment. A single measure reporting a decrease of at least 10% was considered definitive only if it was the last one available for the participant.|<=14 days prior to the first dose of study medication, on day 1, day 28 of every cycle, at the end of treatment visit, at the 28 day FUP visit and monthly thereafter for up to 3 months or until initiation of another anticancer therapy up to 35 months|The Full Analysis Set (FAS) consists of all randomized patients analyzed according to the treatment and stratum they were assigned to at randomization.||Months||95% Confidence Interval|Median
793301|NCT00903175|Secondary|Time to Definitive Deterioration of the Physical Functioning Scale of the EORTC QLQ-C30 - by First and Second-Line Drugs Combined|The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) contains 30 items. These include a global health status/QoL scale, five functional scales, three symptom scales, and six single items.The standardized score for the PF, fatigue subscales and global health status ranges from 0 to 100, with a higher score representing a high level of functioning/high level of symptom/high quality of life. Definitive deterioration by at least 10% was defined as a decrease in score by at least 10% compared to baseline, with no later increase above this threshold observed during the first line or second line treatment. A single measure reporting a decrease of at least 10% was considered definitive only if it was the last one available for the participant.|<=14 days prior to the first dose of study medication, on day 1, day 28 of every cycle, at the end of treatment visit, at the 28 day FUP visit and monthly thereafter for up to 3 months or until initiation of another anticancer therapy up to 35 months|The Full Analysis Set (FAS) consists of all randomized patients analyzed according to the treatment and stratum they were assigned to at randomization.||Months||95% Confidence Interval|Median
793309|NCT00903175|Primary|Progression Free Survival First-Line (PFS 1-L)|PFS_1L based on investigator assessment of radiology data by RECIST 1.0, was defined as the time from the date of randomization to the date of the first documented disease progression or death due to any cause during or after first-line treatment with everolimus or sunitinib. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|based on radiological assessments every 3 months until disease progression, start of another antineoplastic therapy or for any other reason up to 35 months|The Full Analysis Set (FAS) consists of all randomized patients analyzed according to the treatment and stratum they were assigned to at randomization.||Months||95% Confidence Interval|Median
793302|NCT00903175|Secondary|Time to Definitive Deterioration of the Physical Functioning (PF) Scale of the EORTC QLQ-C30 - by First-Line (1L) Drug|The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) contains 30 items. These include a global health status/QoL scale, five functional scales, three symptom scales, and six single items. The standardized score for the PF, fatigue subscales and global health status ranges from 0 to 100, with a higher score representing a high level of functioning/high level of symptom/high quality of life. Definitive deterioration by at least 10% was defined as a decrease in score by at least 10% compared to baseline, with no later increase above this threshold observed during the first line of treatment. A single measure reporting a decrease of at least 10% was considered definitive only if it was the last one available for the participant.|<=14 days prior to the first dose of study medication, on day 1, day 28 of every cycle, at the end of treatment visit, at the 28 day FUP visit and monthly thereafter for up to 3 months or until initiation of another anticancer therapy up to 35 months|The Full Analysis Set (FAS) consists of all randomized patients analyzed according to the treatment and stratum they were assigned to at randomization.||Months||95% Confidence Interval|Median
793303|NCT00903175|Secondary|Time to Definitive Deterioration of the FKSI-DRS Risk Score by at Least 3 Score Units by First and Second-line Drugs Combined|The Functional Assessment of Cancer Therapy – Kidney Symptom Index, Disease Related Symptoms (FKSI-DRS) is a set of items to assess symptoms experienced by patients with advanced kidney cancer. These symptoms include fatigue, pain, weight loss, dyspnea, cough, fever and hematuria. Each item is scored on a 5-point scale (0 = not at all; 4 = very much). The FKSI-DRS total score ranges from 0 (most severe symptoms) to 36 (no symptoms). Definitive deterioration was defined as a decrease by at least 3 units compared to baseline, with no later increase above this threshold observed during the 1-L or 2-L treatment. A single measure reporting a decrease of at least 3 units was considered definitive only if it was the last one available for the patient.|<=14 days prior to the first dose of study medication, on day 1, day 28 of every cycle, at the end of treatment visit, at the 28 day FUP visit and monthly thereafter for up to 3 months or until initiation of another anticancer therapy up to 35 months|The Full Analysis Set (FAS) consists of all randomized patients analyzed according to the treatment and stratum they were assigned to at randomization.||Months||95% Confidence Interval|Median
793304|NCT00903175|Secondary|Time to Definitive Deterioration of the FKSI-DRS Risk Score by at Least 3 Score Units by First-line Drug|The Functional Assessment of Cancer Therapy – Kidney Symptom Index, Disease Related Symptoms (FKSI-DRS) is a set of items to assess symptoms experienced by patients with advanced kidney cancer. These symptoms include fatigue, pain, weight loss, dyspnea, cough, fever and hematuria. Each item is scored on a 5-point scale (0 = not at all; 4 = very much). The FKSI-DRS total score ranges from 0 (most severe symptoms) to 36 (no symptoms). Definitive deterioration was defined as a decrease by at least 3 units compared to baseline, with no later increase above this threshold observed during the 1-L of treatment. A single measure reporting a decrease of at least 3 units was considered definitive only if it was the last one available for the patient.|<=14 days prior to the first dose of study medication, on day 1, day 28 of every cycle, at the end of treatment visit, at the 28 day FUP visit and monthly thereafter for up to 3 months or until initiation of another anticancer therapy up to 35 months|The Full Analysis Set (FAS) consists of all randomized patients analyzed according to the treatment and stratum they were assigned to at randomization.||Months||95% Confidence Interval|Median
793305|NCT00903175|Secondary|Duration of Response (DoR) - First-Line (1-L)|Duration of overall response (CR or PR) applies only to patients whose Best Overall Response (BOR) was Complete Response (CR) or Partial Response (PR) during the first-line treatment period. The start date was the date of first documented response (CR or PR) during the first-line treatment and the end date was the date of the event defined as the first documented progression or death due to underlying cancer during or after the same treatment line.|based on radiological assessments every 3 months until disease progression, start of another antineoplastic therapy or for any other reason up to 35 months|The analysis population corresponds to the patients included in the Full analysis set (i.e. randomized patients analyzed according to the treatment and stratum they were assigned to at randomization) and who achieved a best overall response of CR or PR during the first-line treatment period.||Months||95% Confidence Interval|Median
793306|NCT00903175|Secondary|Overall Response Rate (ORR) - First -Line (1-L)|ORR was defined as the number of participants with best overall response (BOR) of complete response (CR) or partial response (PR) and was based on investigator assessment of radiology data per RECIST. Participants with best overall response of ‘Unknown’ were treated as non-responders in the calculation of the ORR. Confirmed CR = at least two determinations of CR at least 4 weeks apart before progression. Confirmed PR = at least two determinations of PR or better at least 4 weeks apart before progression. CR required a disappearance of all target and non-target lesions. PR required at least a 30% decrease in the sum of the longest diameters of all target lesions, taking as a reference the baseline sum of the longest diameters. Radiological assessments : every 12 weeks until disease progression, the start of another antineoplastic therapy or for any other reason.|based on radiological assessments every 3 months until disease progression, start of another antineoplastic therapy or for any other reason up to 35 months|The Full Analysis Set (FAS) consists of all randomized patients analyzed according to the treatment and stratum they were assigned to at randomization.||percentage of participants|||Number
793307|NCT00903175|Secondary|Overall Survival (OS)|Overall survival was defined as the time from date of randomization to date of death due to any cause. The analysis of OS included all deaths in the FAS regardless of when they were observed.|Every 2 months from randomization up to 3 years after last patient randomized|The Full Analysis Set (FAS) consists of all randomized patients analyzed according to the treatment and stratum they were assigned to at randomization.||Months||95% Confidence Interval|Median
793308|NCT00903175|Secondary|Progression-free Survival Combined (PFS-C)|PFS-C (1L and 2L study drugs combined) was a composite endpoint which combined both lines of study treatment. It was defined as the time from the date of randomization to the first of the following: date of death due to any cause, or date of the first radiologically documented progression disease during or after the second-line treatment period for patients with a radiologically documented progression disease in the first-line treatment period and who had crossed-over to second-line treatment no more than 6 weeks after progression.|based on radiological assessments every 3 months until disease progression, start of another antineoplastic therapy or for any other reason up to about 56 months|The Full Analysis Set (FAS) consists of all randomized patients analyzed according to the treatment and stratum they were assigned to at randomization.||Months||95% Confidence Interval|Median
793310|NCT00903331|Secondary|Number of Patients at Risk of Event of Disease Worsening or Death up to the End of Study|"Disease worsening was indicated by pulmonary function test/idiopathic pulmonary fibrosis worsening (PFT/IPF) or acute respiratory decompensation of IPF.
PFT/IPF worsening was indicated by the occurrence of both of the following: confirmed by two tests at least 4 weeks apart, as defined by the occurrence of both of the following: decrease from baseline ≥ 10% in forced vital capacity and decrease from baseline ≥ 15% in corrected diffusing capacity of the lung for carbon monoxide.
Acute respiratory decompensation of IPF was defined as an unexplained rapid deterioration (over a period of less than 4 weeks) of the patient’s condition with increasing shortness of breath requiring oxygen supplementation ≥ 5 L/min to maintain a resting oxygen saturation ≥ 90% or arterial oxygen pressure ≥ 55 mmHg (sea level) or 50 mmHg (high altitude)."|Up to end of study (Up to 24 months)|All randomized patients||participants|||Number
793311|NCT00903331|Primary|Forced Vital Capacity (FVC) at Baseline and End of Period 1|FVC was measured at baseline and at the end of Period 1. The same equipment and tester were used during the course of the study. The equipment was calibrated and the calibration documented prior to each patient’s measurement. The person responsible for conducting the pulmonary function tests was required to comply with the study guidelines and the American Thoracic Society/European Respiratory Society joint criteria on lung function testing.|12 months|All randomized patients||litres||95% Confidence Interval|Median
793312|NCT00903344|Secondary|Change in Bone Mineral Denisty (BMD) in SPINE at 6 Months|difference in the mean|Change from Baseline to 6 Months|||grams/cm^2||Standard Deviation|Mean
793313|NCT00903344|Secondary|Change in Bone Mineral Denisty (BMD) in SPINE at 3 Months|difference in mean|Change from Baseline to 3 Months|At 3 month visit there had been two participants that dropped out in the Vitamin D - Experimental group. No participants had dropped out in the Multivitamin - Active Comparator group but the test for this specific outcome measure for one of the group's participants was not included in the results.||grams/cm^2||Standard Deviation|Mean
793314|NCT00903344|Secondary|Change in Bone Mineral Density (BMD) at HIP at 3 Months||Change from Baseline to 3 months|At 3 month visit there had been two participants that dropped out in the Vitamin D - Experimental group. No participants had dropped out in the Multivitamin - Active Comparator group but the test for this specific outcome measure for one of the group's participants was not included in the results.||grams/cm^2||Standard Deviation|Mean
793315|NCT00903344|Secondary|Change in 25-hyroxyvitamin D Levels at 6 Months||Change from Baseline to 6 Months|||ng/ml||Standard Deviation|Mean
793316|NCT00903344|Secondary|Change in 25-hyroxyvitamin D Levels at 3 Months|Difference in means between visits|Change from Baseline to 3 Months|At 3 month visit there had been two participants that dropped out in the Vitamin D - Experimental group. No participants had dropped out in the Multivitamin - Active Comparator group but the test for this specific outcome measure for two of the groups' participants was not included in the results.||ng/ml||Standard Deviation|Mean
793317|NCT00903344|Primary|Change in Bone Mineral Density (BMD) in HIP at 6 Months||Change from Baseline to 6 months|||grams/cm^2||Standard Deviation|Mean
793318|NCT00903357|Primary|Changes in Urinary EDN|Changes of Urinary EDN(Eosinophil Derived Neurotoxin) after taking Montelukast or placebo drug. Urinary EDN levels were measured using an ELISA (MBL, Woburn, MA, USA) and the intra-assay and inter-assay variations were 3.0 ± 0.5 and 7.7 ± 1.5, respectively. Minimum value: 0, Maximum value: 2040 ng/ml.|18 weeks after participants recruitment|||Urine EDN (ng/ml)||Standard Deviation|Mean
793319|NCT00903357|Primary|Changes in Urinary LTE4|Changes of Urinary LTE4(Leukotrien E4) after taking Montelukast or placebo drug. Urinary LTE4 levels were measured using an enzyme-linked immunoassay (ELISA) (Cayman Chemical, Michigan, USA) and the intra-assay and inter-assay variations were 7.4 ± 2.1 and 12.4 ± 7.8, respectively. Minimum value : 0 Maximum vlaue: 1000 pg/ml.|18 weeks after patient recruitment|||Urinary LTE4 (pg/ml)||Standard Deviation|Mean
793320|NCT00903357|Primary|Changes in SCORAD Index|Changes of SCORAD(SCORing Atopic Dermatitis) index after taking Montelukast or placebo drug. SCORAD calculation: Extent(%)/5 + 7*Intensity/2 + subjective symptoms (minimum score 0, maximum score 103) (SCORAD index >40: severe, 15-40:moderate, <15: mild)|18 weeks after patient recruitment|||units on a scale||Standard Deviation|Mean
793321|NCT00903370|Secondary|Composite of Death, Stroke, Serious Adverse Events (Cardiac and Non-cardiac), and Cardiac Re-hospitalizations Less Than 30 Days Post-procedure or Hospital Discharge||Less than 30 days post-procedure or hospital discharge|||percentage of patients||95% Confidence Interval|Number
793322|NCT00903370|Primary|Freedom From Atrial Fibrillation||Measured at Month 12|Since the primary analysis is an intent-to-treat, outcomes were imputed for patients with missing data.||percentage of patients||95% Confidence Interval|Number
793323|NCT00903383|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (mm) at Week 12|The value for Erythrocyte Sedimentation Rate (mm) at baseline was subtracted from the value for each of the treatment groups at Week 12.|Baseline and 12 weeks|Intent to Treat Population||mm||Standard Deviation|Mean
793324|NCT00903383|Secondary|Change From Baseline in C-reactive Protein (mg/L) at Week 12|The C-reactive protein value (mg/L) at baseline was subtracted from the value for each of the treatment groups at Week 12.|Baseline and 12 weeks|Intent to Treat Population||mg/L||Standard Deviation|Mean
793325|NCT00903383|Secondary|Hybrid ACR Response at Week 12|Evaluates the improvement in active RA by combining elements of the ACR20/50/70 with a continuous score of the mean change in core set measures. The percentage improvement from baseline was computed in each of the components of the ACR. The average percent improvement was calculated and used with the subject's ACR20, ACR50, and ACR70 status to compute the hybrid ACR response, with a positive change indicating improvement.|Baseline and 12 weeks|Intent to Treat Population||Percent change||Standard Deviation|Mean
793326|NCT00903383|Secondary|ACR70 Response at Week 12|Evaluates the efficacy of LX3305 by utilizing the American College of Rheumatology 70% response criteria (ACR70) at 12 weeks in subjects with active RA also receiving stable doses of MTX. For a response of ACR70, there had to be ≥70% improvement in swollen joint count, ≥70% improvement in painful/tender joint count, and ≥70% improvement in at least 3 of the following: subject's assessment of pain, global assessment of disease activity, assessment of physical function, or acute phase reactant (C-reactive protein or erythrocyte sedimentation rate).|Baseline and 12 weeks|Intent to Treat Population||Participants|||Number
793418|NCT00904215|Secondary|Change in VAS (Visual Analog Scale)|VAS indicates the health status of the patient. Best value=100.0 (best health status), worst value=0.0 (worst health status)|between baseline (visit 1) and after 12 weeks of treatment (visit 3)|||Units on a scale||Standard Deviation|Mean
793328|NCT00903383|Primary|ACR20 Response at Week 12|Evaluates the efficacy of LX3305 by utilizing the American College of Rheumatology 20% response criteria (ACR20) at 12 weeks in subjects with active RA also receiving stable doses of MTX. For a response of ACR20, there had to be ≥20% improvement in swollen joint count, ≥20% improvement in painful/tender joint count, and ≥20% improvement in at least 3 of the following: subject's assessment of pain, global assessment of disease activity, assessment of physical function, or acute phase reactant (C-reactive protein or erythrocyte sedimentation rate).|Baseline and 12 weeks|Intent to Treat Population||Participants|||Number
793329|NCT00903396|Secondary|Average Level of Nausea Reported and the Proportion of Patients Experiencing a Complete Response Independent of Treatment Arm||Up to 2 years|Not enough patients were accrued. In order to avoid identification of patients, no results will be entered.|||||
793330|NCT00903396|Secondary|Tolerability and Adverse Events as Assessed by NCI CTC v 3.0||Up to 2 years|Not enough patients were accrued. In order to avoid identification of patients, no results will be entered.|||||
793331|NCT00903396|Secondary|Proportion of Patients Reporting Treatment Failure||Up to 2 years|Not enough patients were accrued. In order to avoid identification of patients, no results will be entered.|||||
793332|NCT00903396|Secondary|Time to Treatment Failure, Defined as a Single Episode of Vomiting, Daily Nausea Score of Moderate or Greater, or Taking ≥ 3 Prochlorperazine or Haloperidol Tablets Per Day||Up to 2 years|Not enough patients were accrued. In order to avoid identification of patients, no results will be entered.|||||
793333|NCT00903396|Primary|Complete Response (no Episodes of Nausea or Vomiting)||Up to 2 years|Not enough patients were accrued. In order to avoid identification of patients, no results will be entered.|||||
793337|NCT00903448|Primary|Mean Percent Time That Gastric pH > 4.0 on Day 5|for 24 hours starting Day 5 for each period|24 hours|This study was a three period, crossover study of 40 subjects entering either treatment sequence ABB or BAA; consequently each subject in the study participated in three periods over which each subject would eventually receive both Prilosec OTC and Prevacid||percent time gastric pH exceeds 4.0||Standard Error|Mean
793338|NCT00903617|Secondary|Plasma PK- AUC(0-t)|All participants treated with GSK256073 or placebo participated in PK sampling. Blood samples for PK analysis of GSK256073 to determine AUC(0-t) was collected at Week 2, 4, 6 and 8. For samples obtained during time windows, every attempt was made to collect three samples during each time window: pre-dose to 2 hours after dosing, 2 hours to 4.5 hours after dose, and 6 hours to 12 hours after dose. During each window, 3 samples spaced at least 30 minutes apart were collected (i.e., avoid collection from all participants at the same time within a window or only at the extremes of a time window). The AUC 0-t was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations.|0-2 hours after dosing (pre-dose plus 3 samples spaced at least 30 minutes apart), 2 to 4.5 hours after dose (3 samples spaced at least 30 minutes apart) and 6-12 hours post dose (3 samples spaced at least 30 minutes apart) on Week 2, 4, 6 and 8|PK Analysis Population. Only those participants available at the indicated time points were analyzed.||Hour nanogram per milliliter (h*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
793339|NCT00903617|Secondary|Plasma PK- Time of Occurrence of Cmax (Tmax)|All participants treated with GSK256073 or placebo participated in PK sampling. Blood samples for PK analysis of GSK256073 to determine Tmax was collected at Week 2, 4, 6 and 8. For samples obtained during time windows, every attempt was made to collect three samples during each time window: pre-dose to 2 hours after dosing, 2 hours to 4.5 hours after dose, and 6 hours to 12 hours after dose. During each window, 3 samples spaced at least 30 minutes apart were collected (i.e., avoid collection from all participants at the same time within a window or only at the extremes of a time window). The time at which Cmax was observed was determined directly from the raw concentration-time data.|0-2 hours after dosing (pre-dose plus 3 samples spaced at least 30 minutes apart), 2 to 4.5 hours after dose (3 samples spaced at least 30 minutes apart) and 6-12 hours post dose (3 samples spaced at least 30 minutes apart) on Week 2, 4, 6 and 8|PK Population.||Hours||Full Range|Median
793340|NCT00903617|Secondary|Plasma PK- Maximum Observed Concentration (Cmax)|All participants treated with GSK256073 or placebo participated in PK sampling. Blood samples for PK analysis of GSK256073 to determine Cmax was collected at Week 2, 4, 6 and 8. For samples obtained during time windows, every attempt was made to collect three samples during each time window: pre-dose to 2 hours after dosing, 2 hours to 4.5 hours after dose, and 6 hours to 12 hours after dose. During each window, 3 samples spaced at least 30 minutes apart were collected (i.e., avoid collection from all participants at the same time within a window or only at the extremes of a time window). The first occurrence of the Cmax was determined directly from the raw concentration-time data.|0-2 hours after dosing (pre-dose plus 3 samples spaced at least 30 minutes apart), 2 to 4.5 hours after dose (3 samples spaced at least 30 minutes apart) and 6-12 hours post dose (3 samples spaced at least 30 minutes apart) on Week 2, 4, 6 and 8|PK Population was defined as all participants in the PK concentration population for whom PK parameters had been derived.||Nanograms per mililiter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
793419|NCT00904215|Primary|Change in DBP (Diastolic Blood Pressure)|The change of the mean DBP|between baseline (visit 1) and after 12 weeks of treatment (visit 3)|||mmHg||Standard Deviation|Mean
793341|NCT00903617|Secondary|Percent Change From Baseline in Non-esterified Fatty Acids (NEFA) Over Eight Weeks of Administration With GSK256073 or Placebo|Blood samples for analysis of NEFA was collected at Baseline (Week 0) and Week 2, 4, 6 and 8. Baseline was defined at Week 0. Change from Baseline was calculated by subtracting the post-Baseline value from the Baseline value. Percent change from Baseline was calculated by multiplying change from Baseline value with 100.|Baseline (Week 0) up to Week 8|PD Population. Only those participants available at the indicated time points were analyzed.||Percent change||Standard Deviation|Mean
793342|NCT00903617|Secondary|Percent Change From Baseline in Lipoprotein (a) (Lp[a]) Over Eight Weeks of Administration With GSK256073 or Placebo|Blood samples for analysis of Lp[a] was collected at Baseline (Week 0) and Week 2, 4, 6 and 8. Baseline was defined at Week 0. Change from Baseline was calculated by subtracting the post-Baseline value from the Baseline value. Percent change from Baseline was calculated by multiplying change from Baseline value with 100.|Baseline (Week 0) up to Week 8|PD Population. Only those participants available at the indicated time points were analyzed.||Percent change||Standard Deviation|Mean
793343|NCT00903617|Secondary|Percent Change From Baseline in Insulin Over Eight Weeks of Administration With GSK256073 or Placebo|Blood samples for analysis of insulin was collected at Baseline (Week 0) and Week 2, 4, 6 and 8. Baseline was defined at Week 0. Change from Baseline was calculated by subtracting the post-Baseline value from the Baseline value. Percent change from Baseline was calculated by multiplying change from Baseline value with 100.|Baseline (Week 0) up to Week 8|PD Population. Only those participants available at the indicated time points were analyzed.||Percent change||Standard Deviation|Mean
793344|NCT00903617|Secondary|Percent Change From Baseline in Fasting Levels of Total Cholesterol (TC), Triglyceride (TG), Glucose, Low Density Lipoprotein Cholesterol (LDLc), Apolipoprotein A2 (ApoAII), Apolipoprotein B (ApoB) Over 8 Weeks of Administration With GSK256073 or Placebo|Blood samples for analysis of fasting levels of TC, TG, glucose, LDLc, ApoAII and ApoB was collected at Baseline (Week 0) and Week 2, 4, 6 and 8. Baseline was defined at Week 0. Change from Baseline was calculated by subtracting the post-Baseline value from the Baseline value. Percent change from Baseline was calculated by multiplying change from baseline value with 100.|Baseline (Week 0) up to Week 8|PD Population. Only those participants available at the indicated time points were analyzed.||Percent change||Standard Deviation|Mean
793345|NCT00903617|Secondary|Percent Change From Baseline in Fasting Plasma HDLc and Apolipoprotein A-I (ApoA1) Concentrations Over Eight Weeks of Administration With GSK256073 or Placebo|Blood samples for analysis of fasting levels of HDLc and ApoA1 was collected at Baseline (Week 0) and Week 2, 4, 6 and 8. Baseline was defined at Week 0. Change from Baseline was calculated by subtracting the post-Baseline value from the Baseline value. Percent change from Baseline was calculated by multiplying change from baseline value with 100.|Baseline (Week 0) up to Week 8|PD Population. Only those participants available at the indicated time points were analyzed.||Percent change||Standard Deviation|Mean
793346|NCT00903617|Secondary|Mean Episode of Flushing as Measured by Visual Analogue Scale (VAS)|Flushing assessment was captured by participants in individual diaries provided to each study participant. Participants were instructed to return their diaries after each study visit (Week 2, Week 4, Week 6 and Week 8) where they were given a new diary for the time between visits. Participants self-assessed intensity of flushing using a 100 mm VAS once daily at the first flushing episode. The left hand side of the scale (0) represented ‘No Flushing Sensation’ and the right hand side of the scale (100) represented ‘Unbearable Flushing Sensation’. The intensity of flushing of each episode was measured in centimeters (to the nearest 1/100) from the 0 point of the scale. Data is reported for average VAS scores over 8 weeks of treatment.|Up to Week 8|PD Population was defined as all participants who provided PD data.||Scores on a scale||Standard Deviation|Mean
793347|NCT00903617|Secondary|Number of Participants Who Withdrew Due to Flushing|Flushing assessment was captured by participants in individual diaries provided to each study participant. Participants were instructed to return their diaries after each study visit (Week 2, Week 4, Week 6 and Week 8) where they were given a new diary for the time between visits.|Up to follow up (14 days from last dose)|Safety Population.||Participants|||Count of Participants
793348|NCT00903617|Secondary|Participant's Average Duration of Flushing|Flushing assessment was captured by participants in individual diaries provided to each study participant. Participants were instructed to return their diaries after each study visit (Week 2, Week 4, Week 6 and Week 8) where they were given a new diary for the time between visits. Participant’s average duration of flushing was analyzed.|Up to Week 8|PD Population. Only those participants available at the indicated time points were analyzed.||Minutes||Full Range|Median
793349|NCT00903617|Secondary|Average Time to Onset of Flushing|Flushing assessment was captured by participants in individual diaries provided to each study participant. Participants were instructed to return their diaries after each study visit (Week 2, Week 4, Week 6 and Week 8) where they were given a new diary for the time between visits. The time to the onset of the first flushing (if more than one happens to occur on each day) was analyzed.|Up to Week 8|PD Population. Only those participants available at the indicated time points were analyzed.||Hours||Full Range|Median
793350|NCT00903617|Secondary|Average Number of Flushing Episodes|Flushing assessment was captured by participants in individual diaries provided to each study participant. Participants were instructed to return their diaries after each study visit (Week 2, Week 4, Week 6 and Week 8) where they were given a new diary for the time between visits. Participants with average number of flushing episodes was reported as “did not have flushing episode”, “1 flushing episode”, “2 flushing episode” and “3 or more flushing episode”.|Up to Week 8|PD Population.||Participants|||Count of Participants
793351|NCT00903617|Secondary|Number of Participants With Self Reported Assessment of Flushing|Flushing assessment was captured by participants in individual diaries provided to each study participant. Participants were instructed to return their diaries after each study visit (Week 2, Week 4, Week 6 and Week 8) where they were given a new diary for the time between visits. Participants were asked to perform an assessment of their perceived flushing intensity after their completion of VAS assessment once daily after their first flushing episode (if more than one happens to occur). The scale was from 0 to 3, where 0 represents no flushing, 1 represents mild flushing, 2 represents moderate flushing, and 3 represents severe flushing.|Up to Week 8|PD Population.||Participants|||Count of Participants
793420|NCT00904215|Primary|Change in SBP (Systolic Blood Pressure)|The change of the mean SBP|between baseline (visit 1) and after 12 weeks of treatment (visit 3)|In clinical report form (CRF), some patients' SBP was not recorded.||mmHg||Standard Deviation|Mean
793352|NCT00903617|Secondary|Average Global Flushing Score|Flushing assessment was captured by participants in individual diaries provided to each study participant. Participants were instructed to return their diaries after each study visit (Week 2, Week 4, Week 6 and Week 8) where they were given a new diary for the time between visits. Flushing symptom questionnaire (FSQ) was used to measure participant reported feelings of severity associated with different types of flushing symptoms. The FSQ comprised of 11 items. The response scale combined verbal descriptors as well as a 0-10 numerical rating scale. Items 1, 2, 4 and 10 had verbal descriptors. The items 3, 5, 6, 7, 8, 9 and 11 were rated on a 0 to 10 scale (none=0, mild=1–3, moderate=4–6, severe=7–9 and extreme=10). The total score for these items ranged from 0 (not at all) to 70 (extreme). Higher score indicated more severe flushing symptoms and 0 indicated no flushing symptoms.|Up to Week 8|PD Population.||Participants|||Count of Participants
793353|NCT00903617|Secondary|Number of Participants With Abnormal Urinalysis Results|Urinalysis assessment was done for urine occult blood, urine glucose, urine ketones and urine protein over eight weeks treatment period.|Up to Week 8|Safety Population.||Participants|||Count of Participants
793354|NCT00903617|Secondary|Number of Participants With Abnormal Clinical Chemistry Values|Blood samples for assessment of clinical chemistry parameters of blood urea nitrogen, creatinine, glucose (fasting), sodium, creatine phosphokinase, potassium, chloride, total carbon dioxide, calcium, total lactose dehydrogenase (LDH), aspartate aminotransferase (AST), alanine amino transferase (ALT), gamma glutamyl transferase (GGT), alkaline phosphatase, phosphate, total and direct bilirubin, uric acid, albumin and total protein was collected at Baseline and at Weeks 2, 4, 6 and 8.|Up to Week 8|Safety Population. Only those participants with data available at the indicated time points were analyzed.||Participants|||Count of Participants
793355|NCT00903617|Secondary|Number of Participants With Abnormal Hematology Values|Blood samples for assessment of hematology parameters of platelet count, red blood cell count, white blood cell count, hemoglobin, haptoglobin, reticulocyte count, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, neutrophils, lymphocytes, monocytes, eosinophils and basophils was collected at Baseline and at Weeks 2, 4, 6 and 8.|Baseline (Week 0) up to Week 8|Safety Population.||Participants|||Count of Participants
793356|NCT00903617|Secondary|Change From Baseline in Vital Signs-Heart Rate|Heart rate was assessed at Baseline (Week 0), Week 2, 4, 6 and 8. Baseline was defined at Week 0. Change from Baseline was calculated by subtracting the post-Baseline value from the Baseline value.|Baseline (Week 0) up to Week 8|Safety Population. Only those participants available at the indicated time points were analyzed.||Beats per minute||Standard Deviation|Mean
793357|NCT00903617|Secondary|Change From Baseline in Vital Signs-Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|SBP and DBP was assessed at Baseline (Week 0), Week 2, 4, 6 and 8. Baseline was defined at Week 0. Change from Baseline was calculated by subtracting the post-Baseline value from the Baseline value.|Baseline (Week 0) up to Week 8|Safety population. Only those participants available at the indicated time points were analyzed.||Millimeters of mercury (mmHg)||Standard Deviation|Mean
793358|NCT00903617|Secondary|Number of Participants With Electrocardiography (ECG) Findings|Single 12-lead ECGs was obtained at each time point during the study using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and QTc intervals. Participants with normal, abnormal- clinically significant (CS) and abnormal- not clinically significant (NCS) ECG values were reported.|Up to Week 8|Safety Population. Only those participants available at the indicated time points were analyzed.||Participants|||Count of Participants
793359|NCT00903617|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect, medically significant or it is associated with liver injury and impaired liver function.|Up to follow up (14 days from last dose)|Safety Population was defined as all participants who received at least one dose of study drug.||Participants|||Count of Participants
793360|NCT00903617|Primary|The GSK256073 Area Under Concentration-time Curve (AUC) and High Density Lipoprotein Cholesterol (HDLc) Data to Evolve the Exposure-response Pharmacokinetic/Pharmacodynamic (PK/PD) Relationship for Changes in HDLc Levels|The potential PK/PD relationship was to be assessed by plotting GSK256073 AUCs against HDLc. The PK/PD model that was to be used for the simulations in the study design was to be refined with the Part A observed AUC exposures and HDLc levels. However, the study was stopped for futility at the end of Part A due to lack of a compelling PK/PD relationship between GSK256073 and lipid effects that would predict success in achieving significant HDLc raising.|Week 2, 4, 6 and 8|Data was not collected as the study was stopped for futility at the end of Part A due to lack of a compelling PK/PD relationship between GSK256073 and lipid effects that would predict success in achieving significant HDLc raising.|||||
793361|NCT00903630|Secondary|Phase 2 - Number of Subjects Who Are Progression-Free and Alive|"Progression is defined as:
At least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurement, or the appearance of one or more new lesion(s)."|6 months after starting treatment|||participants|||Number
793362|NCT00903630|Secondary|Phase 2 - Number of Subjects Who Are Progression-Free and Alive|"Progression is defined as:
At least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s)."|3 months after starting treatment|||participants|||Number
793363|NCT00903630|Primary|Phase 2 - Number of Subjects Achieving a Partial or Complete Response|"Partial response is defined as:
At least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter. To be assigned a status of partial response, changes in tumor measurements must be confirmed by repeat assessments performed no less than four weeks after the criteria for response are first met.
Complete response is defined as:
The disappearance of all target lesions. To be assigned a status of complete response, changes in tumor measurements must be confirmed by repeat assessments performed no less than four weeks after the criteria for response are first met."|3 months after starting treatment|||participants|||Number
793421|NCT00904371|Secondary|Number of Participants Not Completing Study|Number of participants discontinuing study early for given reason|3rd visit (4-10 months)|Patients with data at 3rd visit (4-10 months)||Participants|||Number
793364|NCT00903630|Primary|Phase 1 - Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)|DLT is defined as the inability to complete cycle 1 and/or begin cycle 2 within 7 days of the planned start due to a grade 4 or greater hemtologic toxicity or a grade 3 or greater non-hematologic toxicity. Grading was based on Common Toxicity Criteria (CTC) Version 4.|within 5 weeks of starting treatment|||participants|||Number
793365|NCT00903630|Primary|Phase 1 - Maximum Tolerated Dose (MTD) of Lenalidomide When Combined With Fixed Dose Liposomal Doxorubicin in Women With Recurrent Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancer|The maximum tolerated dose (MTD) reflects the highest dose of Lenalidomide when combined with fixed dose Liposomal Doxorubicin at which no more than one out of 6 participants experiences a dose limiting toxicity (DLT).|1 cycle (28 days)|||milligrams (mg)|||Number
793366|NCT00903682|Secondary|Resistance Determinations|The evolution of viral genotype and phenotype was assessed by the number of patients with resistance-associated mutations emerging at the endpoint. A mutation was considered emerging if it was present at endpoint and not present at baseline or any pre-baseline assessment. (NNRTI = non-nucleoside reverse transcriptase inhibitor; NRTI = nucleoside reverse transcriptase inhibitor; RAM = resistance-associated mutation, IAS-USA = International AIDS Society - USA)|at baseline and all subsequent visits until week 48 in case if virologic failure|ITT: the set of all randomized patients who have taken at least 1 dose of trial medication, regardless of their compliance with the protocol||number of participants|||Number
793367|NCT00903682|Secondary|Mean Change From Baseline in CD4+ Cell Count|The mean change in CD4+ cell count from baseline was calculated with a last observation carried forward method; i.e. the last observed value was carried forward, irrespective of the reason for discontinuation.|at baseline and week 2, 6, 12, 24, 36 and 48|ITT: the set of all randomized patients who have taken at least 1 dose of trial medication, regardless of their compliance with the protocol||number of cells/L (x10^6)||Standard Error|Mean
793368|NCT00903682|Secondary|Neuropsychiatric Adverse Events by Week 48|The percentage of patients with at least 1 treatment emergent Grade 1 -4 neurologic or psychiatric adverse event, judged by the investigator to be at least possibly related to the study drug.|from baseline to week 48|ITT: the set of all randomized patients who have taken at least 1 dose of trial medication, regardless of their compliance with the protocol.||percentage of patients|||Number
793369|NCT00903682|Secondary|Mean Change From Baseline in Neuropsychiatric and Total Tolerabililty Score|"The HIV Patient Symptoms Profile measures the tolerability of HIV treatment from the patient's perspective, using 14 concept scales in maximum 84 questions. The response options include a no or yes answer to Did symptom occur?. If yes, there is a problem scale which ranges from 1 = I had this symptom and it was not a problem to 5 = I had this symptom and it was a severe problem. A neuropsychiatric tolerability score is composed as the sum of 21 items and ranges from 0 (best) to 105 (worse). A total Tolerability score (ie, the sum of all items) ranges from 0 (best) to 420 (worse)"|between baseline and week 48|ITT: the set of all randomized patients who have taken at least 1 dose of trial medication, regardless of their compliance with the protocol.||points on a scale||Standard Error|Mean
793370|NCT00903682|Secondary|Antiviral Activity of ETR vs. EFV|The proportion of patients with confirmed plasma viral load <200 copies/mL at Week 48 as assessed by Time to Loss of Virologic Response (TLOVR)|between baseline and week 48|ITT: the set of all randomized patients who have taken at least 1 dose of trial medication, regardless of their compliance with the protocol.||Number of participants|||Number
793371|NCT00903682|Secondary|Antiviral Activity of ETR vs. EFV|The proportion of patients with confirmed plasma viral load <50 copies/mL at Week 48 as assessed by Time to Loss of Virologic Response (TLOVR)|between baseline and week 48|ITT: the set of all randomized patients who have taken at least 1 dose of trial medication, regardless of their compliance with the protocol.||Number of participants|||Number
793372|NCT00903682|Primary|Proportion of Patients With at Least 1 Treatment-emergent Grade 1-4 Central Nervous System or Psychiatric Adverse Event|Proportion of patients with at least 1 treatment-emergent Grade 1-4 Central Nervous System or psychiatric Adverse Event, observed between Baseline through Week 12 and judged by investigator to be at least possibly related to the study drug in ETR group versus EFV group. All Adverse Events were graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (“DAIDS AE grading table”). Grade 1-4 covers all severities.|between baseline and 12 weeks|The intent-to-treat (ITT) population has been defined as the set of all patients who were randomized and who have taken at least one dose of trial medication, regardless of their compliance with the protocol.||percentage of patients|||Number
793373|NCT00903695|Primary|Differences in Instrumental Activities of Daily Living (IADL) Scores Over 12 Months, by Study Group|IADL is a behavior rating scale using 9 domains of household and community activities, with a total score of 27 points indicating less competence than a normal function score of 9 points. Outcome measure is results of an ANOVA of the differences between baseline and end/last score, by study arm/group, to detect statistically significant differences (nutriceutical vs placebo).|baseline to 12 months|All subjects who completed 12-month study were included.||units on a scale||Standard Error|Mean
793374|NCT00903695|Primary|Differences in Activities of Daily Living (ADL) Scores Over 12 Months, by Study Group|ADL is a behavior rating scale with 6 domains of self-care (feeding, toileting, etc.) in which a maximum score of 18 indicates less competence than a minimum score of 6 (normal skills). Outcome measure is results of ANOVA of the differences between baseline and last/end scores, by study arm/group, to detect any statistically significant differences.|baseline to 12 months|All subjects who completed 12-month study were included.||units on a scale||Standard Error|Mean
793375|NCT00903695|Primary|Differences in Neuropsychiatric Inventory (NPI) Scores Over 12 Months, by Study Group|NPI is a behavior rating scale with 12 categories in which a maximum score of 36 points indicates more pathology than a minimum score of 0. Outcome measure reported here is results of an ANOVA of the differences between baseline and end scores, by study arm/group, to detect any statistically significant difference (nutriceutical vs placebo groups) was completed.|baseline to 12 months|All subjects who completed 12-month study were included.||units on a scale||Standard Error|Mean
793376|NCT00903695|Primary|Differences in MiniMental State Exam (MMSE) Scores Over 12 Months, by Study Group|MiniMental State Exam is a cognitive screening device with possible 30 points in several categories; higher points indicate greater competence. Clinician tests orientation, attention, language, & visuo-spatial construction. Outcome measure is results of an ANOVA of differences between baseline and end/last scores, by study arm/group was completed.|baseline to 12 months|All subjects who completed the 12-month study were included.||units on a scale||Standard Error|Mean
793377|NCT00903695|Primary|Differences in Clock Drawing Test (CLOX) Scores Over 12 Months, by Study Group|Clock Drawing Test is a cognitive screening instrument in which subjects are to draw a clock and set a specified time. Various scoring methods can be employed using 4 to 15 points, with more points showing more competence. This study used the 8-point scoring method, so that 0-8 points could be assigned during each of the baseline and 4 assessment periods during the 12-month study. ANOVA of the differences between baseline and end scores, by study arm/group was completed.|baseline to 12 months|All subjects who completed the 12-month study were included.||units on a scale||Standard Error|Mean
793378|NCT00903695|Primary|Differences in Clinical Dementia Rating Scale (CDR) Over 12 Months, by Study Group|CDR is a rating scale for 8 aspects of behavior with 0-3 points allowed; higher scores indicate more pathology. Total minimum and maximum scores are 0 and 36 respectively.Clinician rates the patient's behavior and competence with input from family members who live with the patient. ANOVA of differences between baseline and end scores of the CDR scale are reported here, by the study arm/group.|baseline before intervention to 12 months of intervention|All subjects who completed the 12-month study were included (placebo and nutriceutical arms/groups).||units on a scale||Standard Error|Mean
793379|NCT00903695|Primary|Differences in Dementia Rating Scale (DRS) at 12 Months From Baseline, by Study Group|Dementia Rating Scale (DRS) is a cognitive test with 5 domains; raw scores can be converted to percentiles for age/education levels, so individuals can be compared. Higher scores mean more competence (0-36 points converted to percentiles so different ages can be compared). Total raw scores for the 5 domains were computed so that Mean and SD of differences between first and last assessments for all subjects, by study arms (nutriceutical = XL and placebo = PL) are reported here.|Baseline and 12 months|All participants who completed 12-month study were included in the ANOVA analysis of the differences in scores of tests between baseline and end assessments.||units on a scale||Standard Deviation|Mean
793380|NCT00903695|Secondary|Number of Subjects Who Converted to Early Alzheimer's (Dementia).|Neurological diagnosis is based on test scores that reach -1.6 SD of mean for age/education, and on radiological tests of brain structure (CT, MRI, PET). Usual cutoff for test score percentile is <0.05 to diagnose dementia.|12 months|Subjects diagnosed as Mild Cognitive Impairment (MCI) in VA clinic were given opportunity to participate in the study if they met inclusion/exclusion criteria (no illnesses that cause brain damage or are uncontrolled such as brittle diabetes).||participants|||Number
793381|NCT00903877|Primary|Visual Analogue Scale of Pain Intensity|Patients rated their pain at baseline, placebo, T3 at 25 mcg, and T3 at 50 mcg. The scale ranged from 0 (no pain) to 10 (pain as bad as it can be).|12 weeks|||Units on a scale||Standard Deviation|Mean
793382|NCT00903929|Secondary|Median Number of Platelet Transfusions up to the Day of Engraftment||baseline to day of engraftment|||units of platelets||Full Range|Median
793383|NCT00903929|Secondary|Median Time to Platelet Engraftment|Determined for all participants who completed at least 75% of the planned doses. Platelet engraftment was as defined by the Center for International Blood and Marrow Transplant Research as the first of 3 consecutive days of a platelet count 20,000/mL without platelet trans-fusions for 7 days and/or the first day of a platelet count 100,000/mL without platelet transfusions for 7 days.|1.5 years|||days||Full Range|Median
793384|NCT00903929|Primary|Maximum Tolerated Dose (MTD) of Eltrombopag|The MTD was defined as the highest dose if no dose limiting toxicity was observed, or the highest dose at which less than one-third of the patients experienced toxicities not expected in the standard stem cell transplantation setting.|1.5 years|||mg/day|||Number
793385|NCT00903968|Secondary|Duration of Response (DOR) [Phase II]|DOR is defined as the time from response to disease progression or death, or date last known progression-free and alive for those who have not progressed or died. DOR was estimated using the Kaplan-Meier method.|DIsease was assessed to document response every cycle on treatment and post-treatment every 12 weeks until progression.|All Phase II participants with measureable disease present at baseline and received at least one dose of the study drug were evaluable for DOR.||Months||95% Confidence Interval|Median
793386|NCT00903968|Secondary|Time to Progression (TTP) [Phase II]|TTP is defined as the time to progression (time from registration to progression, censored at date last known progression-free for those who have not progressed). This is estimated using the Kaplan-Meier method.|DIsease was assessedto document progression every cycle on treatment and post-treatment every 12 weeks until progression.|All Phase II participants with measureable disease present at baseline and received at least one dose of the study drug were evaluable for TTP.||Months||95% Confidence Interval|Median
793387|NCT00903968|Primary|Response Rate of Plerixafor, Bortezomib, and Dexamethasone in Relapsed or Relapsed/ Refractory Multiple Myeloma (ORR) [Phase II]|Overall response was established based on International Myeloma Working Group (IMWG) criteria with 6 potential categories: Complete Response (CR), Very Good Partial Response (VGPR), Partial Response (PR), Minimal Response (MR), Stable Disease (SD), and Progressive Disease (PD).|Disease was assessed for response every cycle on treatment.|All participants with measureable disease at baseline and received at least one dose of the study drug were evaluable for response.||Participants|||Number
793388|NCT00903968|Primary|Dose Limiting Toxicity (DLT) [Phase I]|A DLT was defined as (a) grade 3 or greater non-hematologic toxicity, considered by the investigator to be related to plerixafor or bortezomib, with the exception of nausea, vomiting or diarrhea unless receiving maximal medical therapy, (b) grade 4 hematologic toxicity defined as: thrombocytopenia with platelets <10,000 on more than one occasion within first cycle despite transfusion. Grade 4 neutropenia must occur for more than 5 days and/or result in neutropenic fever with elevated temperature (defined as > 101 degrees F). (c) inability to receive Day 1 dose for Cycle 2 due to toxicity. All adverse events were graded according to the CTEP Common Toxicity Criteria (CTCAE v.3.0).|Participants were assessed every 3 weeks while on study; The observation period for MTD evaluation was the first 21 days of treatment.|All Phase I participants who received at least one dose of the study drug were evaluable for DLT.||Participants with DLT|||Number
793389|NCT00903968|Primary|Bortezomib Maximum Tolerated Dose (MTD) [Phase I]|The MTD plerixafor in combination with bortezomib is determined by the number of patients who experience a dose limiting toxicity (DLT). See subsequent primary outcome measure for the DLT definition. The MTD is defined as highest dose level at which fewer than one-third of patients experience a DLT. The MTD was reached at dose level 5B.|Participants were assessed every 3 weeks while on study; The observation period for MTD evaluation was the first 21 days of treatment.|All Phase I participants who received at least one dose of the study drug were evaluable for MTD.||mg/m2, days 3, 6, 10, 13 of 21|||Number
793390|NCT00903968|Primary|Plerixafor Maximum Tolerated Dose (MTD) [Phase I]|The MTD plerixafor in combination with bortezomib is determined by the number of patients who experience a dose limiting toxicity (DLT). See subsequent primary outcome measure for the DLT definition. The MTD is defined as highest dose level at which fewer than one-third of patients experience a DLT. The MTD was reached at dose level 5B.|Participants were assessed every 3 weeks while on study; The observation period for MTD evaluation was the first 21 days of treatment.|All Phase I participants who received at least one dose of the study drug were evaluable for MTD.||ug/kg, days 1, 2, 3, 6, 10, 13 of 21|||Number
793391|NCT00904007|Secondary|Provider-perceived Barriers and Facilitators to the Spaced Education Intervention||Months 1-12||||||
793392|NCT00904007|Secondary|Providers' Perceptions of the Optimal Parameters for the Spaced Education Intervention||Months 1-12||||||
793393|NCT00904007|Secondary|Provider-perceived Effectiveness of Spaced Education Intervention||Months 1-12||||||
793394|NCT00904007|Secondary|Provider-perceived Acceptability of Spaced Education Intervention||Months 1-12||||||
793395|NCT00904007|Secondary|Performance Differences by Provider-related Variables (Site of Care, Age, Date of Recertification, Sex, Etc.) in the Spaced Education Program (Spaced Education Cohort Only)||Months 1-12||||||
793396|NCT00904007|Secondary|Baseline Knowledge Levels of Providers Assessed Via Their Initial Responses to Spaced Education Items (Spaced Education Cohort Only)||Months 1-12||||||
793397|NCT00904007|Secondary|Cross-cohort Comparison of Providers' Post-test Scores (Score Improvements)||Months 1-12||||||
793398|NCT00904007|Secondary|Pre-test Performance Differences by Provider-related Variables (Site of Care, Age, Date of Recertification, Etc.)||Month 1||||||
793399|NCT00904007|Secondary|Cross-cohort Comparison of Patients' Follow-up Intervals After Clinical Encounters With Elevated Blood Pressure||Months 1-24||||||
793400|NCT00904007|Secondary|Cross-cohort Comparison of Frequency of Treatment Intensification||Months 1-24||||||
793401|NCT00904007|Secondary|Cross-cohort Comparison of Patients' Average Change in Blood Pressure Over Months 1-24 (Last Measured Blood Pressure in Months 1-24)||Months 1-24||||||
793402|NCT00904007|Secondary|Cross-cohort Comparison of Patients' Average Blood Pressure at 24 Months After Trial Launch (Last Measured Blood Pressure in Months 1-24)||Months 1-24||||||
793403|NCT00904007|Secondary|Cross-cohort Comparison of Patients' Average Change in Blood Pressure Over Months 13-24 (Last Measured Blood Pressure in Months 13-24)||Months 13-24||||||
793404|NCT00904007|Secondary|Cross-cohort Comparison of Patients' Average Blood Pressure at 24 Months After Trial Launch (Last Measured Blood Pressure in Months 13-24)||Months 13-24||||||
793405|NCT00904007|Secondary|Cross-cohort Comparison of Patients' Average Change in Blood Pressure Over Months 1-12 (Last Measured Blood Pressure in Months 1-12)||Months 1-12||||||
793406|NCT00904007|Secondary|Cross-cohort Comparison of Patients' Average Blood Pressure at 12 Months After Trial Launch (Last Measured Blood Pressure in Months 1-12)||Months 1-12||||||
793407|NCT00904007|Primary|Cross-cohort Comparison of the Average Time Needed to Normalize Patients' Blood Pressure|A unique hypertensive period served as the unit of analysis. A hypertensive period started on the first day during the study when a patient’s BP was elevated. It ended on the first subsequent day when it was <140/90 mm Hg or on the last day BP was recorded during the study. Duration of the hypertensive period (days) was the outcome measure. BP measurements obtained in the course of routine care were used to ascertain study outcomes, whether obtained by the PCP or at other clinic visits. These measurements were obtained from structured data (ie, BP recordings in the electronic medical record) and natural language processing of provider notes as previously described. If several measurements were recorded on the same day, the lowest mean arterial BP was used.|Months 1-24|||days||Full Range|Median
793408|NCT00904150|Secondary|Menstrual Cycle Expression of TNF and SYNE1 in Women With Menstrual Migraine and Women Without Migraine|TNF and SYNE1|6 years|Matched luteal and follicular phase samples Not all samples were suitable for analysis for each outcome measure||number of genes expressed||Standard Deviation|Mean
793409|NCT00904150|Primary|Menstrual Cycle Expression of PGR and ESR in Women With Menstrual Migraine and Women Without Migraine|PgR and ESR|6 years|Matched pairs of follicular and luteal samples Not all samples were suitable for analysis for each outcome measure||number of genes expressed||Standard Deviation|Mean
793410|NCT00904150|Primary|Estrogen Receptor 1 C325G Polymorphism in Women With Menstrual Migraine and Women Without Migraine|ESR1 C325G|6 years|Not all samples were suitable for analysis for each outcome measure||participants|||Number
793411|NCT00904150|Secondary|SYNE1 Genotype in Women With Menstrual Migraine and Women Without Migraine|SYNE1|6 years|Not all samples were suitable for analysis for each outcome measure||participants|||Number
793412|NCT00904150|Secondary|Tumour Necrosis Factor Genotype in Women With Menstrual Migraine and Women Without Migraine|TNF|6 years|Not all samples were suitable for analysis for each outcome measure||participants|||Number
793413|NCT00904150|Primary|Estrogen Receptor 1 G594a Polymorphism in Women With Menstrual Migraine and Women Without Migraine|ESR1 G594A|6 years|Not all samples were suitable for analysis for each outcome measure||participants|||Number
793414|NCT00904150|Primary|Progesterone Receptor Gene Polymorphism PROGINS in Women With Menstrual Migraine and Women Without Migraine|PR PROGINS|6 years|Not all samples were suitable for analysis for each outcome measure||participants|||Number
793415|NCT00904189|Secondary|Determination of the Range of Background Signal Measured by the EPR Device.||2.5 years|The study enrolled only 2 subjects and then was substantially changed. After the amendment, no further subjects were enrolled. The data collected from the two enrolled subjects was not analyzed and therefore is not available.|||||
793416|NCT00904189|Primary|Mean Dose of Radiation Received by Fingernails|The mean dose in gray of radiation exposure to participants fingernails as determined by Electron Paramagnetic Resonance (EPR).|2.5 years|The study enrolled only 2 subjects and then was substantially changed. After the amendment, no further subjects were enrolled. The data collected from the two enrolled subjects was not analyzed and therefore is not available.|||||
793417|NCT00904215|Primary|Change in WHO-QOL (WHO-Quality Of Life)|"World Health Organization-Quality Of Life (WHO-QOL), change in quality of life was assessed.
Best value=130.0 (highest quality of life), worst value=0.0 (lowest quality of life)"|between baseline (visit 1) and after 12 weeks of treatment (visit 3)|||Units on a scale||Standard Deviation|Mean
793422|NCT00904371|Secondary|Number of Patients With Adverse Events (AE)||4-10 months|Treated patients||Participants|||Number
793427|NCT00904371|Primary|Change From Baseline in Framingham Stroke Risk Assessment Score|The risk assessment tool using data from the Framingham Heart Study to estimate 10-year risk for stroke, measured in percent. Low risk (10 or less stroke risk at 10 years), intermediate risk (10-20), high risk (20 or more).|Baseline to 3rd visit (4-10 months)|Patients with data both at baseline and on 3rd visit (4-10 months)||units on a scale||Standard Deviation|Mean
793428|NCT00904371|Primary|Change From Baseline in Framingham CVD Risk Assessment Score|10-year risk for hard coronary heart disease (CHD) outcomes (Myocardial Infarction and coronary death), according to Framingham Heart Study, measured in percent. Low risk (10 or less CHD risk at 10 years), intermediate risk (10-20), high risk (20 or more).|Baseline to 3rd visit (4-10 months)|Patients with data both at baseline and on 3rd visit (4-10 months)||units on a scale||Standard Deviation|Mean
793429|NCT00904371|Primary|Change From Baseline in SCORE (10 Year Risk for Fatal Cardiovascular Event)|A 10 year risk of fatal cardiovascular disease (CVD) in populations at high risk. Minimum 0 percent risk to Maximum 47 percent risk.|Baseline to 3rd visit (4-10 months)|Patients with data both at baseline and on 3rd visit (4-10 months)||units on a scale||Standard Deviation|Mean
793430|NCT00904371|Primary|Change From Baseline in Diastolic Blood Pressure (DBP)||Baseline to 3rd visit (4-10 months)|Patients with data both at baseline and on 3rd visit (4-10 months)||mm Hg||Standard Deviation|Mean
793431|NCT00904371|Primary|Change From Baseline in Systolic Blood Pressure (SBP)||Baseline to 3rd visit (4-10 months)|Patients with data both at baseline and on 3rd visit (4-10 months)||mm Hg||Standard Deviation|Mean
793432|NCT00904423|Secondary|Serum Calcium and Fasting Spot Urine Calcium/Creatinine Ratio||every 4 months|Data are not accessible.|||||
793433|NCT00904423|Secondary|Arthralgias and Myalgias||every 4 months|Data are not accessible.|||||
793434|NCT00904423|Secondary|Bone Turnover Markers||months 4 and 12|Data are not accessible.|||||
793435|NCT00904423|Secondary|Change in Hip Bone Mineral Density (BMD) T-score||one year|Data are not accessible.|||||
793436|NCT00904423|Primary|Spine Bone Mineral Density T Score Change Over One Year||1 year|Data are not accessible.|||||
793437|NCT00904618|Secondary|Safety of the Sling.|Safety of the sling was assessed with a record of perioperative and postoperative complications. The following are all the complications experienced with the TVT-SECUR for each technique, the 'Hammock' technique and the 'U-Method'.|15 months|The ‘Hammock’ technique, similar to the transobturator tape dissection, was used in the first 23 cases and the ‘U-Method’, similar to the retropubic tape dissection, in the last 25 cases. Interim analysis performed after 23 cases led us to change the technique to the ‘U-Method’.||Participants|||Number
793438|NCT00904618|Secondary|Improvement in Stress Urinary Symptoms.|A questionnaire with a Likert scale from one to five was used to assess the improvement in stress urinary symptoms at six months for each technique, the 'Hammock' technique and the 'U-Method' (1-Worst, 2-Same, 3-Improved, 4-Almost cured, 5-Cured). Patients had to answer 3 or more on the scale to be considered improved.|Six months|The ‘Hammock’ technique, similar to the transobturator tape dissection, was used in the first 23 cases and the ‘U-Method’, similar to the retropubic tape dissection, in the last 25 cases. Seven patients for the 'Hammock' technique and three patients for the 'U-Method' did not fill out the questionnaire at six months.||participants|||Number
793439|NCT00904618|Primary|Local Anesthesia Satisfaction|Local anesthesia satisfaction was assessed with a questionnaire completed by the patients. The patients were asked if they would recommend this type of anesthesia (yes or no).|Questionnaire filled 1 week after surgery|2 patients did not fill out the questionnaire 1 week after surgery||participants|||Number
793440|NCT00904670|Other Pre-specified|SKAMP Compliance Subscale Score Over 12 Hours|SKAMP scale measures the manifestations of ADHD using an independent observer rating of the participant’s impairment in classroom observed behaviors. SKAMP composite score is comprised of 13 items [subscales: attention (1-4 items), deportment (5-8 items), quality of work (9-11 items) and compliance (12-13 items)]. SKAMP composite score is obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for total possible combined score of 0 to 78; where higher score signified worst impairment. SKAMP compliance subscale is reported which comprises of 2 items, with a total possible score of 0 to 12; higher score indicates worst impairment.|0.75, 2, 4, 8, 10, 12 hours post-dose|Intent-to-Treat (ITT) analysis set included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) and had at least 1 post-baseline efficacy assessment. N (number of participants analyzed)= participants evaluable for this measure.||units on a scale||Standard Deviation|Mean
793441|NCT00904670|Other Pre-specified|SKAMP Quality of Work Subscale Score Over 12 Hours|SKAMP scale measures the manifestations of ADHD using an independent observer rating of the participant’s impairment in classroom observed behaviors. SKAMP composite score is comprised of 13 items [subscales: attention (1-4 items), deportment (5-8 items), quality of work (9-11 items) and compliance (12-13 items)]. SKAMP composite score is obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for total possible combined score of 0 to 78; where higher score signified worst impairment. SKAMP quality of work subscale is reported which comprises of 3 items, with a total possible score of 0 to 18; higher score indicates worst impairment.|0.75, 2, 4, 8, 10, 12 hours post-dose|Intent-to-Treat (ITT) analysis set included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) and had at least 1 post-baseline efficacy assessment. N (number of participants analyzed)= participants evaluable for this measure.||units on a scale||Standard Deviation|Mean
793442|NCT00904670|Secondary|SKAMP Combined Scores Over 12 Hours|The SKAMP scale measures the manifestations of attention deficit hyperactivity disorder (ADHD) using an independent observer rating of the participant’s impairment in classroom observed behaviors. SKAMP combined score is comprised of 13 items (including subscales: attention with items 1-4, deportment with items 5-8, quality of work with items 9-11 and compliance with items 12-13). The SKAMP combined score was obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for a total possible combined score of 0 to 78; where higher score signified worst impairment.|0.75, 2, 8, 10, 12 hours post-dose|Data for combined SKAMP score was collected and reported through the measure of onset and duration of clinical effects as given in outcome measure 2.|||||
793443|NCT00904670|Secondary|Permanent Product Measure of Performance (PERMP) Score Over 12 Hours|The PERMP is a 10-minute written test, on 80 math problems, performed as seatwork in the classroom. At the end of the 10-minute math test , the PERMP score of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session was used to measure a participant’s performance. The total score range from 0-160 with higher scores indicating better performance.|0.75, 2, 4, 8, 10, 12 hours post-dose|Intent-to-Treat (ITT) analysis set included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) and had at least 1 post-baseline efficacy assessment. N (number of participants analyzed)= participants evaluable for this measure.||units on a scale||Standard Deviation|Mean
793444|NCT00904670|Secondary|SKAMP Deportment Subscale Score Over 12 Hours|SKAMP scale measures the manifestations of ADHD using an independent observer rating of the participant’s impairment in classroom observed behaviors. SKAMP combined score is comprised of 13 items [subscales: attention (1-4 items), deportment (5-8 items), quality of work (9-11 items) and compliance (12-13 items)]. SKAMP combined score is obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for total possible combined score of 0 to 78; where higher score signified worst impairment. SKAMP deportment subscale is reported which assesses behavior in the classroom and comprises of 4 items, with a total possible score for each sub-scale of 0 to 24; higher score indicates worst impairment.|0.75, 2, 4, 8, 10, 12 hours post-dose|Intent-to-Treat (ITT) analysis set included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) and had at least 1 post-baseline efficacy assessment. N (number of participants analyzed)= participants evaluable for this measure.||units on a scale||Standard Deviation|Mean
793445|NCT00904670|Secondary|SKAMP Attention Subscale Score Over 12 Hours|SKAMP scale measures the manifestations of ADHD using an independent observer rating of the participant’s impairment in classroom observed behaviors. SKAMP combined score is comprised of 13 items [subscales: attention (1-4 items), deportment (5-8 items), quality of work (9-11 items) and compliance (12-13 items)]. SKAMP combined score is obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for total possible combined score of 0 to 78; where higher score signified worst impairment. SKAMP attention subscale is reported which evaluates concentration in the classroom and comprises of 4 items, with a total possible score for of 0 to 24; higher score indicates worst impairment.|0.75, 2, 4, 8, 10, 12 hours post-dose|Intent-to-Treat (ITT) analysis set included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) and had at least 1 post-baseline efficacy assessment. N (number of participants analyzed)= participants evaluable for this measure.||units on a scale||Standard Deviation|Mean
793446|NCT00904670|Secondary|Onset and Duration of Clinical Effect Based on SKAMP-Combined Scale|Onset and duration is determined using SKAMP combined rating scale at each post-dose time point. Onset of effect is defined as first assessment time showing statistical significance (i.e. p is less than or equal to [=<] 0.05) between NWP06 and placebo and duration of effect is defined as the as last consecutive time-point at which difference is still statistically significant between NWP06 and placebo. SKAMP scale measures the manifestations of ADHD using an independent observer rating of the participant’s impairment in classroom observed behaviors. SKAMP combined score is comprised of 13 items [subscales: attention (1-4 items), deportment (5-8 items), quality of work (9-11 items) and compliance (12-13 items)]. SKAMP combined score is obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for total possible combined score of 0 to 78; where higher score signified worst impairment.|0.75, 2, 8, 10, 12 hours post-dose|Intent-to-Treat (ITT) analysis set included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) and had at least 1 post-baseline efficacy assessment. N (number of participants analyzed)= participants evaluable for this measure.||units on a scale||Standard Deviation|Mean
793447|NCT00904670|Primary|Swanson, Kotin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP)-Combined Scores at Hour 4 Post-Dose|The SKAMP scale measures the manifestations of attention deficit hyperactivity disorder (ADHD) using an independent observer rating of the participant’s impairment in classroom observed behaviors. SKAMP combined score is comprised of 13 items (including subscales: attention with items 1-4, deportment with items 5-8, quality of work with items 9-11 and compliance with items 12-13). The SKAMP composite score was obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for a total possible combined score of 0 to 78; where higher score signified worst impairment.|Hour 4 post-dose|Intent-to-Treat (ITT) analysis set included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) and had at least 1 post-baseline efficacy assessment. N (number of participants analyzed)= participants evaluable for this measure.||units on a scale||Standard Deviation|Mean
793448|NCT00904722|Secondary|Progression-Free Survival|Progression-Free Survival (PFS) was measured from enrollment to disease progression or recurrence or death from any cause.|Measured after completion of the second and fourth infusions of CT-011, and every 12 weeks thereafter for 2 years or until relapse.|One patient was withdrawn after one infusion of CT-011 as per the treating physician's decision.||months||95% Confidence Interval|Median
793449|NCT00904722|Primary|Overall Response Rate|Overall response (OR) rate defined as complete response (CR) + partial response (PR). CR: Complete disappearance of all detectable clinical evidence of disease and symptoms if present before therapy. If a PET scan was positive before therapy, a post-treatment residual mass of any size was deemed a complete response provided that it was PET negative. If response was determined by CT scan criteria, lymph nodes that regressed to less than 1·5 cm were deemed to be complete response. The spleen and/or liver, if considered enlarged before therapy should not be palpable on physical examination and be considered normal size by imaging studies, and nodules related to lymphoma should disappear. PR: At least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses. No increase in the size of other nodes, liver, or spleen. Splenic and hepatic nodules must regress by ≥ 50% in their SPD. No new sites of disease should be observed.|Response measured after completion of the second and fourth infusions of CT-011, and every 12 weeks thereafter for 2 years or until relapse.|One patient was withdrawn after one infusion of CT-011 as per the treating physician's decision.||participants|||Number
793450|NCT00904748|Secondary|Number of Participants With Clinically Significant Findings in Vital Signs|Clinically significant abnormalities in blood pressure (BP), pulse, and temperature reported as an adverse event. Clinically significant = values outside the normal range and/or values judged as significant by the investigator (normal range: systolic BP 100-140 mmHg; diastolic BP 60- 90 mmHg; temperature 35-37°Celsius). Pulse rate based on investigator discretion.|Day 1 (Period 1), Day 8 (Period 2), and Day 15 (Period 3): Pre-dose and 0.5, 1, 2, 4, 8 and 12 hours post-dose.|Safety population: all subjects who received at least 1 dose of study medication. Although individual listing data for vital signs were collected, summary statistics were not generated for this outcome measure.||participants|||Number
793451|NCT00904748|Secondary|Half-life (T 1/2)|Terminal elimination half-life.|Day 1 (Period 1), Day 8 (Period 2), and Day 15 (Period 3): Pre-dose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose|Participants for pharmacokinetic analysis = participants who completed all of the 3 treatment periods.||hours||Standard Deviation|Mean
793452|NCT00904748|Secondary|Time to Maximum Plasma Concentration (Tmax)|Time at which maximum plasma concentration (Cmax) occurred.|Day 1 (Period 1), Day 8 (Period 2), and Day 15 (Period 3): Pre-dose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose|Participants for pharmacokinetic analysis = participants who completed all of the 3 treatment periods.||hours||Standard Deviation|Mean
793453|NCT00904748|Secondary|Area Under the Curve From 0 to Infinity (AUC 0-inf )|Area under the blood concentration-time profile from time zero extrapolated to infinite time measured in nanograms *hour/milliliter (ng*hr/mL).|Day 1 (Period 1), Day 8 (Period 2), and Day 15 (Period 3): Pre-dose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose|Participants for pharmacokinetic analysis = participants who completed all of the 3 treatment periods.||ng*hr/mL||Standard Deviation|Mean
793454|NCT00904748|Primary|Maximum Plasma Concentration (Cmax)|Maximum plasma concentration measured in nanograms per milliliter (ng/mL).|Day 1 (Period 1), Day 8 (Period 2), and Day 15 (Period 3): Pre-dose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose|Participants for pharmacokinetic analysis = participants who completed all of the 3 treatment periods.||ng/mL||Standard Deviation|Mean
793455|NCT00904748|Primary|Area Under the Curve (AUC 0-t)|Area under the blood concentration-time profile from time zero to last experimentally determined concentration measured in nanograms*hour/milliliter (ng*hr/mL).|Day 1 (Period 1), Day 8 (Period 2), and Day 15 (Period 3): Pre-dose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose|Participants for pharmacokinetic analysis = participants who completed all of the 3 treatment periods.||ng*hr/mL||Standard Deviation|Mean
793456|NCT00904826|Secondary|Mean Complement Protein 5 (C5) Concentration in CSF||baseline, 3 months|At 3 months, C5 was undetectable in 6 subjects; patient 13 was excluded because she had temporarily discontinued treatment.||ng/mL||Standard Deviation|Mean
793457|NCT00904826|Secondary|Mean Eculizumab Concentration in Cerebrospinal Fluid (CSF)||3 months|12 subjects including subject 13 agreed to have CSF draw at the 3 month visit, but subject 13 was excluded because she had temporarily discontinued treatment.||ng/mL||Standard Deviation|Mean
793458|NCT00904826|Secondary|Percentage Hemolysis|Percentage of hemolysis is a measure of complement activity. Less than 20% lysis is deemed to be complete complement inhibition.|baseline, 6 weeks, 3 months, 6 months, 9 months, 12 months|Subject 13 was excluded at 3 months visit because she had temporarily discontinued treatment.||percentage of hemolysis||Standard Deviation|Mean
793459|NCT00904826|Secondary|Mean Serum Concentration of Eculizumab||6 weeks, 3 months, 6 months, 9 months, 12 months|Patient 13 was excluded from the 3 months measurement because she had temporarily discontinued treatment.||micrograms/mL||Standard Deviation|Mean
793460|NCT00904826|Secondary|Number of Subjects With Change in Ambulation by at Least 1 Point|Ambulation was measured by the Hauser Ambulation Index, which ranges from 0 (asymptomatic; fully active) to 9 (restricted to wheelchair; unable to transfer self independently.)|12 months|||participants|||Number
793461|NCT00904826|Secondary|Number of Subjects With Change in Visual Acuity in at Least One Eye by at Least One Point|Visual acuity was measured using the the Visual Acuity subscale of the Opticospinal Impairment Score (OSIS) for Exacerbations. This subscale ranges from 0 (normal) to 8 (no light perception).|12 months|||participants|||Number
793462|NCT00904826|Secondary|Change in Expanded Disability Status Scale (EDDS) Score|The EDSS is an ordinal clinical rating scale ranging from 0 (normal neurologic examination) to 10 (death) in half-point increments.|baseline, 12 months|||units on a scale||95% Confidence Interval|Mean
793463|NCT00904826|Secondary|Number Subjects Experiencing an NMO Attack in 12 Months of Eculizumab Treatment||12 months|||participants|||Number
793464|NCT00904826|Primary|Median Number of Neuromyelitis Optica (NMO) Attacks Per Year||baseline, after 12 months of treatment|||attacks per year||Full Range|Median
793465|NCT00904839|Secondary|Exploratory Biomarker and Pharmacogenetic Analysis for VEGF|"Exploratory biomarker and pharmacogenetic analysis for Vascular endothelial growth factor (VEGF).
Note: This endpoint was not statistically analysed in this study."|Day 1, Day 29, Day 57, Day 85 and Day 127||||||
793466|NCT00904839|Secondary|Number of Participants for Quality of Life Evaluation by a Standardised Questionnaires of EORTC: EORTC-QLQ-CR38 for the First Use of Stoma Bag.|Number of participants for Quality of life evaluation by a standardised questionnaires of European Organisation for Research and Treatment of Cancer (EORTC): EORTC-QLQ-CR38 for the first use of stoma bag.|from baseline until end of treatment, up to 892 days|Treated Set (TS).||participants|||Number
793467|NCT00904839|Secondary|Quality of Life Evaluation by a Standardised Questionnaires of EORTC: EORTC-QLQ-CR38 for the Change From Baseline at 9 Months.|"Quality of life evaluation by a standardised questionnaires of European Organisation for Research and Treatment of Cancer (EORTC): EORTC-QLQ-CR38 for the change from baseline at 9 months for functional scales, Symptom scales Chemotherapy side effects .
The EORTC-QLQ-CR38 was composed of functioning scales (body image, future perspective, sexual enjoyment, sexual functioning) and symptom scales (chemotherapy side effects, defecation problems, symptoms of the gastrointestinal tract, micturition problems,female sexual problems, male sexual problems, stoma related problems, and weight loss).
Raw scores are transformed to scales of 0-100. A higher score is associated with a better quality of life for functional scales and a worse quality of life for symptom scales."|Baseline and 9 months.|Treated Set (TS)||units on scale||Standard Deviation|Mean
793468|NCT00904839|Secondary|Quality of Life Evaluation by a Standardised Questionnaires of EORTC: EORTC-QLQ-C30 for the Change From Baseline at 9 Months of Global Health Status Scores.|"Quality of life evaluation by a standardised questionnaires of European Organisation for Research and Treatment of Cancer (EORTC): EORTC-QLQ-C30 for the change from baseline at 9 months for Global health status scores.
Raw scores are transformed to scales of 0-100. A higher score is associated with a better quality of life for Global health status scores"|Baseline and 9 months.|Treated Set (TS). Number of analysed patients are the total number of patients who were analysed for the change from baseline at 9 months for Global health status scores||units on scale||Standard Deviation|Mean
793469|NCT00904839|Secondary|Maximum Plasma Concentration for Nintedanib at Steady State and Normalized by the Dosing Unit Administered (Cmax,ss,Norm) (Phase I)|Maximum plasma concentration for Nintedanib at steady state and normalized by the dosing unit administered (Cmax,ss,norm) (Phase I)|-0:05h before drug administration and 1h, 2h, 2.5h, 3h, 4h, 6h, 8h, and 10h after drug administration.|Treated Set (TS).||ng/mL/mg||Geometric Coefficient of Variation|Geometric Mean
793470|NCT00904839|Secondary|Area Under the Plasma Concentration Time-curve Over 12 Hours for Nintedanib in the Dosing Interval at Steady State and Normalized by the Dosing Unit Administered (AUCtau,ss,Norm) (Phase I)|Area under the plasma concentration time-curve over 12 hours for Nintedanib in the dosing interval at steady state and normalized by the dosing unit administered (AUCtau,ss,norm) (Phase I)|-0:05h before drug administration and 1h, 2h, 2.5h, 3h, 4h, 6h, 8h and 10h after drug administration.|Treated Set (TS).||ng*h/mL/mg||Geometric Coefficient of Variation|Geometric Mean
793471|NCT00904839|Secondary|Maximum Tolerable Dose (MTD)|Determination of Maximum Tolerable Dose based on DLT incidence.|First two treatment cycles, up to 28 days|MTD Set||mg|||Number
793472|NCT00904839|Secondary|Percentage of Patients With Dose Limit Toxicity (DLTs) Incidence During the First Two Treatment Cycles (Phase I).|Percentage of patients with DLTs,AE were observed in Gastrointestinal,Hepatobiliary & skin and subcutaneous tissue disorder.Drug related DLT was defined:1)Gastrointestinal toxicity(vomiting, nausea and diarrhoea)or hypertension of CTCAEgrade(G)3 despite optimal supportive care/intervention.2)Non-haematological toxicity of G≥3 except AE:alopecia,nail modifications,& isolated elevation of gamma glutamyl transpeptidase.3)G4 neutropenia for>7days(not associated with fever≥38.5°C).4)Neutropenia of G≥3 of any duration associated with fever≥38.5ºC.5)Platelets <25,000/μLorG3 thrombocytopenia associated with bleeding requiring transfusion.6)Inability to resume nintedanib dosing within14days of stopping due to treatment related toxicity.7)ALT and/or AST elevation of G≥3orG≥2 in conjunction with bilirubin G>1. 8)Inability to recover from increase ALT/AST in conjunction with increase of bilirubin toALT/AST toG≤1 &bilirubin to normal or baseline within14days after nintedanib treatment interruption|First two treatment cycles, up to 28 days|MTD set: The first 12-18 patients randomised to the nintedanib treatment group, treated with nintedanib according to the dose escalation part of the study. The outputs (updated with cleaned and more complete data) that were used to decide on the MTD of nintedanib while the study was ongoing.||percentage of participants|||Number
793473|NCT00904839|Secondary|Incidence and Intensity of Adverse Events With Grading According CTCAE|Incidence and intensity of Adverse Events with grading according to the Common Terminology Criteria for Adverse Events (CTCAE version 3.0).|From the first dose of study medication up to 28 days after the day of the last intake of study medication, up to 920 days|Treated Set (TS)||participants|||Number
793474|NCT00904839|Secondary|Tumor Shrinkage|"For each patient, the minimum percentage increase from baseline measurement (≤ 28 days before the beginning of the treatment) of the sum Longest diameter (LD) of target lesions was calculated based on the measurements of tumor size. The minimum percentage increase has been divided to four groups:
<= - 30%
> - 30% and < 0%
>= 0% and < 20%
>=20%"|Baseline and day 85|Treated Set (TS)||participants|||Number
793475|NCT00904839|Secondary|Resection Rate|"Surgical excision of the lesions is allowed if the previous assessment of tumoral response occurred after at least 6 cycles of treatment. Resection Rate includes resection rates R0, R1 and R2 before progressive disease.
Peto's variance estimate was used."|First treatment administration until end of treatment, up to 892 days|Treated Set (TS)||percentage of Participants||95% Confidence Interval|Number
793476|NCT00904839|Secondary|Unconfirmed Objective Response Rate|Objective response is defined as a best response of either complete (CR) or partial response (PR) according to RECIST version 1.0. To be assigned a status of PR or CR, changes in tumour measurements had to be confirmed by repetition of the CT or MRI scan no less than 4 weeks after the criteria for response were first met. This confirmation was necessary to avoid overestimating the response rate observed. The 95% Confidence interval represent the Clopper- Pearson exact confidence interval.|First treatment administration until end of treatment, up to 892 days|Treated Set (TS).||percentage of Participants||95% Confidence Interval|Number
793477|NCT00904839|Secondary|Confirmed Objective Response Rate|Objective response rate is defined as a best response of either complete (CR) or partial response (PR) according to RECIST version 1.0. To be assigned a status of PR or CR, changes in tumour measurements had to be confirmed by repetition of the CT or MRI scan no less than 4 weeks after the criteria for response were first met. This confirmation was necessary to avoid overestimating the response rate observed. The 95% confidence interval represent the Clopper-Pearson exact confidence interval|First treatment administration until end of treatment, up to 892 days|Treated Set (TS).||percentage of Participants||95% Confidence Interval|Number
793478|NCT00904839|Secondary|Progression-free Survival (PFS)|PFS is defined as the time from first treatment with the trial drug until either the onset of progressive disease or death throughout the whole study. Progression is assessed according to RECIST criteria (version 1.0). In this endpoint, the Greenwood's variance estimate was used to calculate the Kaplan-Meier progression free survival median and its corresponding 95% confidence interval|First treatment administration until end of treatment, up to 892 days|Treated Set (TS).||months||95% Confidence Interval|Median
793479|NCT00904839|Secondary|Overall Survival|Overall survival is defined as the time from first treatment until death. Greenwood variance was used for the calculation of 95% confidence interval.|First treatment administration until end of treatment, up to 892 days|Treated Set (TS).||months||95% Confidence Interval|Median
793493|NCT00905021|Primary|Time to Disease Progression in Weeks|Time from the first day of treatment to date of progression in weeks|Medical evaluation every 4 weeks;The study does not have a fixed time frame for each participant. Duration of therapy depends on individule response, evidence of disease progression and tolerance|2 patients developed disease progression.||week||Full Range|Mean
793480|NCT00904839|Primary|Progression-free Survival Rate at 9 Months (PFS-9)|"PFS-9 is defined as the time from first treatment with the trial drug until either the onset of progressive disease or death. A patient is defined as progression-free for 9 months if their PFS was at least 270 days. Progression is assessed according to following mentioned RECIST criteria (version 1.0).
20% increase in the sum of the longest diameter of target lesions.
The appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions."|First treatment administration to nine months|Treated Set (TS) - The treated set includes all patients who were dispensed and were documented to have taken at least one dose of the trial drug.||percentage of Participants||95% Confidence Interval|Number
793481|NCT00904917|Secondary|Child's Report on Parental Behavior Inventory (CRPBI)|Child's Report on Parental Behavior Inventory (CRPBI; Schludermann & Schludermann, 1970) assesses children's and parents’ perceptions of parental acceptance, permitting psychological autonomy, and level of parental control. The 10-item acceptance scale which assesses parental warmth was administered. The acceptable scale has items scored from 1 to 3 (not like me, somewhat like me, a lot like me). Items are summed with a total range is 10 to 30. Higher scores represents greater warmth exhibited by mother to child. Separate forms are available for both child and parent report.|Measured at baseline and post-treatment (8 weeks after baseline)|These scores are based on the CRPBI, which was administered to both the mothers and their children of the dyadic mother-child intervention and control groups. Post-intervention scores based on 5 mothers and 9 children in Adapted PIP (4 participants lost to follow-up) and 6 mothers and 6 children in Lecture group (4 participants lost to follow-up).||units on a scale||Standard Deviation|Mean
793482|NCT00904917|Secondary|Understanding Mood Disorders Questionnaire (UMDQ)|Understanding Mood Disorders Questionnaire (UMDQ; Gavazzi, Fristad, & Law, 1997) measures attributions and knowledge of symptoms, course, and treatment of mood disorders and a symptom checklist. It has 39 items and two subscales. A range of total score is 0 to 59. The first 20 questions are true/false questions and correct responses are scored 2 points each. Nineteen questions are a checklist of symptoms and correct identification of those depression and manic symptoms are scored 1 point each. All items are summed for a total score. Higher scores indicate greater knowledge of mood disorders. Both maternal and child reporters completed this measure.|Measured at baseline and post-treatment (8 weeks after baseline)|These scores are based on the UMDQ, which was administered to both the mothers and their children of the dyadic mother-child intervention and control groups. Post-intervention scores based on 5 mothers and 9 children in Adapted PIP (4 participants lost to follow-up) and 6 mothers and 6 children in Lecture group (4 participants lost to follow-up).||units on a scale||Standard Deviation|Mean
793483|NCT00904917|Primary|Multidimensional Anxiety Scale for Children (MASC)|Multidimensional Anxiety Scale for Children (MASC; March et al., 1997) is a self-report instrument that measures a broad range of anxiety symptoms in youth. The MASC consists of 39 items using a 4-point Likert scale that are distributed across four major factors, three of which can be parsed into two subfactors each. Main and subfactors include (1) physical symptoms (tense/restless and somatic/autonomic), (2) social anxiety (humiliation/rejection and public performance fears), (3) harm avoidance (perfectionism and anxious coping), and (4) separation anxiety. Scores are summed and converted to T-scores. The total T score ranges from 25 to 90 with higher scores representing greater levels of anxiety.|Measured at baseline and post-treatment (8 weeks after baseline)|These scores are based on the MASC which was administered solely to the children of the dyadic mother-child intervention and control groups. Post-intervention scores based on 9 children in Adapted PIP (2 lost to follow-up) and 6 children in Lecture group (2 lost to follow-up).||T scores||Standard Deviation|Mean
793484|NCT00904917|Primary|Children Depression Inventory (CDI)|Children Depression Inventory (CDI; Kovacs, 1992) is a widely-used self-report scale of depressive symptoms suitable for use by youth ranging from 7 to 17 years. The CDI is a 27-item scale that is self-rated and symptom-oriented. The 27 items on the assessment are grouped into five major factor areas. The item score are rated 0-2 with a total scores summed and converted to T scores. The total T score ranges from 33 to 100 with high scores indicating higher levels of depressive symptoms.|Measured at baseline and at post-treatment (8 weeks after baseline)|These scores are based on the CDI which was administered solely to the children of the dyadic mother-child intervention and control groups. Post-intervention scores based on 9 children in Adapted PIP (2 lost to follow-up) and 6 children in Lecture group (2 lost to follow-up).||T scores||Standard Deviation|Mean
793485|NCT00904943|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 168 hour period|Data from all subjects who completed the study was included in the statistical analysis.||ng*hr/mL||Standard Deviation|Mean
793486|NCT00904943|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 168 hour period|Data from all subjects that completed the study was included in the statistical analysis.||ng*hr/mL||Standard Deviation|Mean
793487|NCT00904943|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 168 hour period|Data from all subjects that completed the study was included in the statistical analysis.||ng/mL||Standard Deviation|Mean
793488|NCT00904982|Primary|Improved Warfarin Adherence/% Timeout of Target INR Range||six months|This analysis required multiple INR results. If those were not available for a subject, they were excluded from the primary analysis.||percentage of out of target INR range||Inter-Quartile Range|Median
793489|NCT00904995|Primary|Percentage of Samples With BG Levels > 60pg/ml|"Rate calculated as number of participants with positive levels divided by total number of participants. beta-d-glucan (BG), a cell wall constituent of fungi, can be detected in serum as a marker of Invasive fungal infections (IFI).
Blood samples were drawn on first 2 days of treatment at baseline (before the drug) and at 1, 2, 4, 8 hours after the first dose of the day. BG serum levels were measured using the Fungitell assay, using a cut off value of 60 pg/ml for positivity."|Up to 42 days|Analysis was intent to treat with a total of 182 samples (mean 8.6 samples/participant) drawn from participants.||percent of blood samples|Participants||Number
793490|NCT00905021|Secondary|Study Molecular Changes in Tissue Biopsies, Circulating Tumor Cells, and Circulating Endothelial Cells||5 years||||||
793491|NCT00905021|Secondary|Determine the Safety and Tolerability||5 years||||||
793492|NCT00905021|Secondary|Obtain Assessments of Overall Response Rate, Clinical Benefit Rate, and Overall Survival||5 years|The study was terminated early before target accrual.|||||
793494|NCT00905034|Primary|Complete Response (CR) Rate|Rate calculated as number of participants with CR. Complete Remission (CR) defined as Normalization of peripheral blood and bone marrow with 5% or less blasts in a normocellular or hypercellular marrow with a granulocyte count of 1 x 10^9/L or above and platelet count of 100 x 10^9/L or above. Complete resolution of all sites of extramedullary disease is required for CR.|6 cycles (cycle = 28 days)|Of the 37 participants enrolled, 36 participants completed therapy and were evaluable for response.||percentage of participants|||Number
793495|NCT00905125|Primary|Number of Participants With a Four-fold or Greater Rise in HAI Antibody Titer Against Each Antigen in the 2008-2009 Seasonal Influenza Trivalent Influenza Vaccine|Blood was collected for HAI assay at Day 0 prior to vaccination and again at 28 days following vaccination. The HAI assay was conducted with the three antigens in the 2008-2009 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen. A participant met the threshold of a four-fold increase in titer if the Day 0 titer was less than 10 (the assay's lowest level of detection) and the Day 28 titer was 40 or greater, or the Day 0 titer was greater than or equal to 10, and the Day 28 titer was an increase by four-fold or more.|Day 0 prior to and Day 28 receiving a single dose.|Participants are included in this ITT analysis if blood was collected at both timepoints. One participant was excluded because the baseline blood draw was done after vaccination.||Participants|||Number
793496|NCT00905125|Secondary|Microneutralization Assay Geometric Mean Antibody Titers Against Each Antigen in the 2008-2009 TIV|Blood was collected for microneutralization assay at Day 0 prior to vaccination and again at 28 days following vaccination. The microneutralization assay was to be conducted with the three antigens in the 2008-2009 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen.|Day 0 prior to and Day 28 after receiving a single dose.|Microneutralization assays were deemed not necessary by the sponsor and conduct of these assays is not planned.||Participants|||Number
793497|NCT00905125|Primary|Hemagglutination Inhibition Assay (HAI) Geometric Mean Titer (GMT) Against Each Antigen in the 2008-2009 Seasonal Influenza Trivalent Influenza Vaccine|Blood was collected for HAI assay at Day 0 prior to vaccination and again at 28 days following vaccination. The HAI assay was conducted with the three antigens in the 2008-2009 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen.|Day 0 prior to and Day 28 after receiving single dose.|Participants are included in this ITT analysis if blood was collected at both timepoints. One participant was excluded because the baseline blood draw was done after vaccination.||Titer||95% Confidence Interval|Mean
793498|NCT00905125|Primary|Number of Participants Reporting Fever Based on the Protocol-defined Grading Scale for Oral Temperature|Participants recorded a daily oral temperature on a memory aid for 8 days (Days 0-7) after vaccination. The protocol defined mild fever as oral temperatures 37.8 to less than 38 degree Celsius, moderate fever as 38 to less than 39 degrees Celsius and severe fever as oral temperatures of 39 degrees Celsius or higher. Participants are reported at the highest severity experienced across the 8 days.|Days 0-7 after vaccination.|All participants are included in the ITT safety population for this outcome measure.||Participants|||Number
793499|NCT00905125|Primary|Number of Participants Reporting Solicited Systemic Symptoms at Each Severity Based on the Functional Grading Scale|Participants recorded a daily maximum severity at which systemic symptoms of feverishness, malaise, myalgia, headache and nausea were experienced. Mild reactions had no interference with daily activities, moderate reactions interfered with daily activity, and severe reactions were defined as preventing daily activity. Participants are reported at the highest severity experienced across the 8 days.|Days 0-7 after vaccination.|All participants are included in the ITT safety population for this outcome measure.||Participants|||Number
793500|NCT00905125|Primary|Number of Participants Reporting Measured Injection Site Reactions of Swelling and Redness at Each Grade|Participants recorded a daily measured value of swelling and redness, if present. The protocol defined grading of small, medium and large, with small as less than 20 mm, medium as 20-50 mm and large as greater than 50 mm. Participants are counted at the largest measured grade experienced across the 8 day period after vaccination.|Days 0-7 after vaccination.|All participants are included in the ITT safety population for this outcome measure.||Participants|||Number
793501|NCT00905125|Secondary|Number of Participants With a Four-fold or Greater Rise in Microneutralization Antibody Titer Against Each Antigen in the 2008-2009 TIV|Blood was collected for microneutralization assay at Day 0 prior to vaccination and again at 28 days following vaccination. The microneutralization assay was to be conducted with the three antigens in the 2008-2009 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen. The threshold of a four-fold increase in titer would be met if the Day 0 titer was less than 10 (the assay's lowest level of detection) and the Day 28 titer was 40 or greater, or the Day 0 titer was greater than or equal to 10, and the Day 28 titer was an increase by four-fold or more.|Day 0 prior to and Day 28 receiving a single dose.|Microneutralization assays were deemed not necessary by the sponsor and conduct of these assays is not planned.||Participants|||Number
793502|NCT00905125|Secondary|Number of Participants With a Serum Microneutralization Antibody Titer of Greater Than or Equal to 40 Against Each Antigen in the 2008-2009 TIV|Blood was collected for microneutralization assay at Day 0 prior to vaccination and again at 28 days following vaccination. The microneutralization assay was to be conducted with the three antigens in the 2008-2009 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen.|Day 0 prior to and Day 28 after receiving a single dose.|Microneutralization assays were deemed not necessary by the sponsor and conduct of these assays is not planned.||Participants|||Number
793503|NCT00905125|Primary|Number of Participants Reporting Solicited Injection Site Reactions at Each Severity Based on the Functional Grading Scale|Participants recorded a daily maximum severity at which local reactions of pain, tenderness and swelling were experienced. Mild reactions had no interference with daily activities, moderate reactions interfered with daily activity, and severe reactions were defined as preventing daily activity. Participants are reported at the highest severity experienced across the 8 days.|Days 0-7 after vaccination.|All participants are included in the ITT safety population for this outcome measure.||Participants|||Number
793504|NCT00905125|Primary|Number of Participants Reporting Unsolicited Non-serious Adverse Events Considered Associated With Vaccination|Unsolicited non-serious adverse events were collected from participants at follow up contacts, either by phone or in clinic, through 28 days after vaccination. Association to vaccination was determined by a clinician licensed to make a medical diagnosis and listed on the site's Federal Drug Administration's Form 1572.|Day 0 through Day 28 post vaccination.|All participants are included in the ITT safety population for this outcome measure.||Participants|||Number
793505|NCT00905125|Primary|Number of Participants Reporting Serious Adverse Events (SAE)|Serious adverse events included any untoward medical occurrence that resulted in death of the mother, fetus or infant; was life threatening to mother, fetus or infant; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof; was a congenital anomaly/birth defect in fetus or infant; or may have jeopardized the mother, fetus or infant, or required intervention to prevent one of the outcomes. All events are included regardless of association to vaccination.|Through 6 months post vaccination.|All participants are included in the ITT safety population for this outcome measure.||Participants|||Number
793506|NCT00905125|Primary|Number of Participants Reporting Neonatal Complications.|Participants were contacted after delivery, and medical records reviewed, to collect neonatal complications. The data collection process followed a prospectively-defined list of complications reported for this outcome measure, some of which may have also been reported as serious adverse events if otherwise meeting those requirements.|At time of delivery.|All live births are included in this outcome measure, which excludes three participants whose pregnancies ended in miscarriage or stillbirth (reported as maternal complications). Three participants gave birth to twins, who are each counted separately.||Participants|||Number
793507|NCT00905125|Primary|Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery.|Participants were contacted after delivery, and medical records reviewed, to collect complications experienced during pregnancy, labor and delivery. The data collection process followed a prospectively-defined list of complications reported for this outcome measure, some of which may have also been reported as serious adverse events if otherwise meeting those requirements.|At time of delivery.|All participants from whom outcome data were collected are included in the ITT safety population for this outcome measure.||Participants|||Number
793508|NCT00905125|Primary|Number of Participants With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer Greater Than or Equal to 40 Against Each Antigen Included in the 2008-2009 Seasonal Inactivated Trivalent Influenza Vaccine (TIV)|Blood was collected for HAI assay at Day 0 prior to vaccination and again at 28 days following vaccination. The HAI assay was conducted with the three antigens in the 2008-2009 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen.|Day 0 prior to and Day 28 after receiving single dose.|Participants are included in this ITT analysis if blood was collected at both timepoints. One participant was excluded because the baseline blood draw was done after vaccination.||Participants|||Number
793509|NCT00905151|Primary|Performance of Glomerular Filtration Rate (GFR) Estimating Equations|Overall bias, median difference (95% confidence interval), mL/min per 1.73 m^2, assessed as the median difference between the measured and estimated GFR across all estimated GFR levels, with positive values indicating an underestimation of measured GFR.|Blood samples for plasma iohexol clearance were taken at approximately 10, 30, 120, and 240 minutes post-iohexol dose.|||mL/min per 1.73 m^2||95% Confidence Interval|Median
793510|NCT00905164|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 168 hour period|Data from all subjects who completed the study was included in the statistical analysis.||ng*hr/mL||Standard Deviation|Mean
793511|NCT00905164|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 168 hour period|Data from all subjects who completed the study was included in the statistical analysis.||ng*hr/mL||Standard Deviation|Mean
793512|NCT00905164|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 168 hour period|Data from all subjects who completed the study was included in the statistical analysis.||ng/mL||Standard Deviation|Mean
793513|NCT00905255|Other Pre-specified|Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia for All Patients During On-Treatment Period|Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the patient required the assistance of another person and was associated with either a plasma glucose less than 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.The on-treatment period was the time from the first dose of study drug up to 3 days after the last dose.|First dose of study drug up to 3 days after the last dose of study drug at Week 76 or early withdrawal|Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered. Analysis was done on the overall group (pooled data from the 2-step and 1-step titration arms) as pre-specified||participants|||Number
793514|NCT00905255|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) for All Patients at Week 52 and 76|Change was calculated by subtracting baseline value from value at week of assessment (Week 52/Week 76). The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 1 day after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 52, 76|mITT population. Number of patients analyzed=patients with baseline and at least 1 post-baseline FPG assessment during on-treatment period and “n” = patients with FPG assessment for the specified category. Analysis was done on the overall group (pooled data from the 2-step and 1-step titration arms) as pre-specified||mmol/L||Standard Deviation|Mean
793515|NCT00905255|Secondary|Change From Baseline in Body Weight for All Patients at Week 52 and 76|Change was calculated by subtracting baseline value from value at week of assessment (Week 52/Week 76). The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 52, 76|mITT population. Number of patients analyzed=patients with baseline and at least 1 post-baseline weight assessment during on-treatment period and “n” = patients with weight assessment for the specified category. Analysis was done on the overall group (pooled data from the 2-step and 1-step titration arms) as pre-specified||kilogram||Standard Deviation|Mean
793516|NCT00905255|Primary|Overview of Adverse Event Profile (Treatment Emergent Adverse Events) of the One-Step and Two-Step Titration Arms Assessed Through Adverse Events Collection and Vital Signs, Electrocardiogram (ECG) and Laboratory Monitoring|Overview of adverse event profile is reported in terms of percentage of patients with treatment emergent adverse events (TEAEs) during the 24-week treatment period: any TEAE; any serious TEAE; any TEAE leading to death; and any TEAE leading to permanent treatment discontinuation.|First dose of study drug up to 3 days after the last dose of study drug at Week 24 or early withdrawal|Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.||percentage of participants|||Number
793517|NCT00905255|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 52 and 76|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 52, 76|mITT population. Number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period and “n” = patients with HbA1c assessment for the specified category. Analysis was done on the overall group (pooled data from the 2-step and 1-step titration arms) as pre-specified||percentage of participants|||Number
793518|NCT00905255|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 52 and 76|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 52, 76|mITT population. Number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period and “n” = patients with HbA1c assessment for the specified category. Analysis was done on the overall group (pooled data from the 2-step and 1-step titration arms) as pre-specified||percentage of participants|||Number
793519|NCT00905255|Secondary|Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) for All Patients at Week 52 and 76|Absolute change = HbA1c value at week of assessment (Week 52/Week 76) minus HbA1c value at baseline. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 52, 76|mITT population. Number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period and “n” = patients with HbA1c assessment for the specified category. Analysis was done on the overall group (pooled data from the 2-step and 1-step titration arms) as pre-specified||percentage of hemoglobin||Standard Deviation|Mean
793520|NCT00905255|Other Pre-specified|Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia for the One-Step and Two-Step Titration Arms During 24-Week Treatment Period|Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the patient required the assistance of another person and was associated with either a plasma glucose less than 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.|First dose of study drug up to 3 days after the last dose of study drug at Week 24 or early withdrawal|Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.||participants|||Number
793521|NCT00905255|Other Pre-specified|Percentage of Patients Requiring Rescue Therapy|Routine fasting self-monitored plasma glucose (SMPG) and central laboratory FPG (and HbA1c after Week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after Week 12) were performed. Threshold values - from Week 4 to Week 8: fasting SMPG/FPG >270 milligram/deciliter (mg/dL) (15.0 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 24: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >8.5%, from Week 24 to end of treatment (Week 76): fasting SMPG/FPG >180 mg/dL (10.0 mmol/L) or HbA1c >8%. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline up to Week 52, Baseline up to Week 76|mITT population.Analysis was done on the overall group (pooled data from the 2-step and 1-step titration arms) as pre-specified||percentage of participants|||Number
793522|NCT00905255|Secondary|Overview of Adverse Event Profile (Treatment Emergent Adverse Events) of All Patients During On-Treatment Period Assessed Through Adverse Events Collection and Vital Signs, ECG and Laboratory Monitoring|Overview of adverse event profile is reported in terms of percentage of patients with TEAEs during the on-treatment period: any TEAE; any serious TEAE; any TEAE leading to death; any TEAE leading to permanent treatment discontinuation. The on-treatment period was the time from the first dose of study drug up to 3 days after the last dose at Week 76.|First dose of study drug up to 3 days after the last dose of study drug at Week 76 or early withdrawal|Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered. Analysis was done on the overall group (pooled data from the 2-step and 1-step titration arms) as pre-specified||percentage of participants|||Number
793523|NCT00905268|Secondary|Change in Peak Workload From Baseline to Week 52|"Assessed by a modified exercise test, in a subset of patients able to undertake this.
Wpeak has been calculated from the following formula: Workload last fully completed stage + (seconds completed in last stage / 60 * (4 [if arm ergonometry] or 10 [if leg ergonometry]))."|1 year|||Watts||Standard Deviation|Mean
793524|NCT00905268|Secondary|Change in Peak Systolic Strain Rate From Baseline to Week 52|Mean Change of Peak systolic longitudinal strain rate (PSLSR) from Baseline to Week 52 in subjects with cardiac involvement (FRDA-CM criteria), where positive value in PSLSR is a deterioration and negative value an improvement.|1 year|Subgroup of subjects with cardiac involvement as defined by Friedreich’s ataxia cardiomyopathy (FRDA-CM)||1/s||Standard Deviation|Mean
793525|NCT00905268|Secondary|Proportion of Patients Improving on Left Ventricular Peak Systolic Strain Rate or Showing a Reduction in Left Ventricular Mass Index (LVMI) With no Worsening in Strain Rate|(In the statistical analysis sub-population presenting with cardiac involvement as defined by the FRDA cardiomyopathy criteria)|1 year|Subgroup of subjects with cardiac involvement as defined by Friedreich’s ataxia cardiomyopathy (FRDA-CM)||percentage of patients|||Number
793526|NCT00905268|Secondary|Proportion of Patients Improving (Responding) on ICARS by a Clinically Relevant Margin|"The International Cooperative Ataxia Rating Scale (ICARS) is a commonly used evaluation and is composed of four clinical sub-scores involving the following: posture and gait, limb coordination, speech and oculomotor function.The ICARS score is the total sum of the sub scores and ranges from 0 to 100, with 100 indicative of the most severely affected outcome.
ICARS Responder Analysis at Week 52: Percentage of subjects Improving by 2.5 Points or More."|week 52|The Intent-To-Treat (ITT) population included all randomized subjects who received at least one dose of the study medication and had a confirmed diagnosis of FRDA, did not take idebenone within one month pre-Screening or between Screening and Visit 1, and were not under idebenone treatment at Baseline according to available PK results at Visit 1.||percentage of patients|||Number
793527|NCT00905268|Secondary|Absolute Change in Friedreich's Ataxia Rating Scale (FARS) Scores From Baseline Assessment to Week 52|The Friedreich Ataxia Rating Scale (FARS) is made up of a measure of ataxia, and activities of daily living subscale and a neurological subscale. The scores from the three subscales are added to generate a total score ranging from 0 to 159, with a higher score indicating a greater level of disability.|Baseline and week 52|The comparison was carried out in the ITT population, on data imputed using the last observation carried forward (LOCF) method.||units on a scale||Standard Deviation|Mean
793528|NCT00905268|Primary|Absolute Change in International Cooperative Ataxia Rating Scale (ICARS) Scores From Baseline Assessment to Week 52|The International Cooperative Ataxia Rating Scale (ICARS) is a commonly used evaluation and is composed of four clinical sub-scores involving the following: posture and gait, limb coordination, speech and oculomotor function.The ICARS score is the total sum of the sub scores and ranges from 0 to 100, with 100 indicative of the most severely affected outcome.|Baseline and week 52|The Intent-To-Treat (ITT) population included all randomized subjects who received at least one dose of the study medication and had a confirmed diagnosis of FRDA, did not take idebenone within one month pre-Screening or between Screening and Visit 1, and were not under idebenone treatment at Baseline according to available PK results at Visit 1.||units on a scale||Standard Deviation|Mean
793529|NCT00905307|Secondary|Discontinuation Rate for Lack of Efficacy or Receipt of Open Label OPC-34712|Efficacy-related discontinuation rate was assessed|Baseline to Week 6|Consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. The LOCF method was used to impute missing data.||Percentage of participants|||Number
793530|NCT00905307|Secondary|Response Rate at Week 6|Response rate was defined as a reduction of ≥ 30% from baseline in PANSS Total Score; or a CGI–I score of 1 (very much improved) or 2 (much improved) at Week 6|Week 6|Consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. The LOCF method was used to impuite missing data.||Percentage of participants|||Number
793531|NCT00905307|Secondary|Mean Clinical Global Impression - Improvement (CGI-I) at Week 6|The rater or investigator rated the particpant’s total improvement whether or not it was due entirely to drug treatment. All responses were compared to the participant’s condition at baseline prior to the first dose of double-blind study medication. Response choices included the following: 0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.|Week 6|Consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. The LOCF method was used to impute missing data.||Units on a scale||Standard Deviation|Mean
793532|NCT00905307|Secondary|Change From Baseline to Week 6 in Clinical Global Impression-Severity of Illness Scale (CGI-S) Score (Double Blind Phase)|The severity of illness for each participant was rated using the CGI–S. To perform this assessment, the rater or investigator answered the following question: “Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?” Response choices include the following: 0=not assessed; 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients|Baseline to Week 6|Consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. The LOCF method was used to impute missing data.||Units on a scale||Standard Deviation|Mean
793533|NCT00905307|Secondary|Change From Baseline to Week 6 in Personal and Social Performance Scale (PSP) (Double Blind Phase)|The PSP is a validated clinician-rated scale that measures personal and social functioning in four domains. The rating is based on four main areas: (a) socially useful activities, including work and study; (b) personal and social relationships; (c) self-care; and (d) disturbing and aggressive behaviors. The ratings are converted to a total score based on a 100-point scale using algorithms to identify the appropriate 10-point interval, and the rater’s judgment to determine the total score within the 10-point interval. Ratings from 71-100 reflect only mild difficulties. Ratings from 31-70 reflect manifest disabilities of various degrees. Ratings from 1-30 reflect functioning so poor that intensive support or supervision is needed.|Baseline to Week 6|Consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. The LOCF method was used to impute missing data.||Units on a scale||Standard Deviation|Mean
793534|NCT00905307|Secondary|Change From Baseline to Week 6 in PANSS Negative Subscale Score (Double Blind Phase)|The PANSS consists of three subscales containing a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicating absence of symptoms and a score of 7 indicating extremely severe symptoms. The 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. PANSS negative subscale score is the sum of the rating scores for the 7 negative scale items from the PANSS panel. The PANSS negative subscale score ranges from 7-49, with higher scores indicating more severe symptoms.|Baseline to Week 6|Consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. The LOCF method was used to impute missing data.||Units on a scale||Standard Deviation|Mean
793535|NCT00905307|Secondary|Change From Baseline to Week 6 in PANSS Positive Subscale Score (Double Blind Phase)|The PANSS consists of three subscales containing a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicating absence of symptoms and a score of 7 indicating extremely severe symptoms. The positive symptom constructs are delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. PANSS positive subscale score is the sum of the rating scores for the 7 positive scale items from the PANSS panel. The PANSS positive subscale score ranges from 7-49, with higher scores indicating more severe symptoms.|Baseline to Week 6|Consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. The LOCF method was used to impute missing data.||Units on a scale||Standard Deviation|Mean
793536|NCT00905307|Primary|Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score (Double Blind Phase)|The PANSS consists of three subscales containing a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicating absence of symptoms and a score of 7 indicating extremely severe symptoms. PANSS total score is the sum of the rating scores for 7 positive scale items, 7 negative scale items and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranges from 30-210, with higher scores indicating more severe symptoms.|Baseline to Week 6|Consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. The last observation carried forward (LOCF) method was used to impute missing data.||Units on a scale||Standard Deviation|Mean
793537|NCT00905346|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration|Bioequivalence based on AUC0-t|Blood samples collected over 168 hour period|Data from all subjects who completed the study was included in the statistical analysis.||ng*hr/mL||Standard Deviation|Mean
793538|NCT00905346|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 168 hour period|Data from all subjects who completed the study was included in the statistical analysis.||ng*hr/mL||Standard Deviation|Mean
793539|NCT00905346|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 168 hour period|Data from all subjects who completed the study was included in the statistical analysis.||ng/mL||Standard Deviation|Mean
793540|NCT00905359|Secondary|Number of Patients With Improvement of Symptoms, Symptoms Recurrence, Decreased Therapeutic Response, no Therapeutic Response and Treatment Failure at 14 Days, 6 Weeks, 6, 12 and 24 Months||14 days, 6 weeks, 6 months, 12 months, and 24 months|Per-protocol population analysis (subjects who were not performed surgical procedure as assigned per randomization were excluded).||participants|||Number
793541|NCT00905359|Secondary|Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-ZCQ Symptom Severity||12 months and 24 months|Intention to treat population analysis: all randomized patients who were operated, and had at least one post-operative assessment.||correlation coefficient|||Number
793542|NCT00905359|Secondary|Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-ZCQ Physical Function||12 months and 24 months|Intention to treat population analysis: all randomized patients who were operated, and had at least one post-operative assessment.||correlation coefficient|||Number
793543|NCT00905359|Secondary|Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-leg Pain||12 months and 24 months|Intention to treat population analysis: all randomized patients who were operated, and had at least one post-operative assessment.||correlation coefficient|||Number
793544|NCT00905359|Secondary|Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-Back Pain||12 months and 24 months|Intention to treat population analysis: all randomized patients who were operated, and had at least one post-operative assessment.||correlation coefficient|||Number
793545|NCT00905359|Secondary|Bony Structure Changes of Spinous Process Assessed by CT at the Follow-up Time Points|Number of subjects who had abnormal bony structure of Spinous process was reported for bony structure changes of Spinous process assessed by CT at the follow-up time points.|baseline, 12 months, and 24 months|Per-protocol population analysis (subjects who were not performed surgical procedure as assigned per randomization were excluded).||participants|||Number
793546|NCT00905359|Secondary|Changes in Stenosis of the Spinal Canal Assessed by Magnetic Resonance Imaging (MRI) at the Follow-up Time Points|The lumen sizes of the spinal central canal were reported for the changes in stenosis of the spinal canal assessed by Magnetic Resonance Imaging (MRI) at the follow-up time points.|baseline, 12 months, and 24 months|Per-protocol population analysis (subjects who were not performed surgical procedure as assigned per randomization were excluded).||mm^2||Standard Deviation|Mean
793547|NCT00905359|Secondary|Percentage of Subjects With Serious Adverse Device Effects||Overall study period, up to 24 months|Safety population: All patients who were operated within this study (either by an APERIUS® procedure or by SDS).||percentage of subjects|||Number
793548|NCT00905359|Secondary|Number of Subjects Requiring Secondary Surgical Intervention||Overall study period, up to 24 months|Safety population: All patients who were operated within this study (either by an APERIUS® procedure or by SDS).||participants|||Number
793549|NCT00905359|Secondary|Mean Percentage Changes From Baseline in Quality of Life Using the Patient-completed SF-36 Questionnaire|The SF-36 questionnaire was used to assess the quality of life. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS and MCS is between 0 and 100, with higher scores denoting better quality of life. Mean percentage changes of SF-36 PCS and MCS from baseline are reported.|14 days, 6 weeks, 6 months, 12 months, and 24 months|Per-protocol population analysis (subjects who were not performed surgical procedure as assigned per randomization were excluded).||percentage of change from baseline||Standard Deviation|Mean
793550|NCT00905359|Secondary|Mean Percentage Change of Visual Analog Scale (VAS) From Baseline in Leg Pain|Patients rated their leg pain using Visual Analog Scale (VAS) from 0 to 10, higher values represents a worse pain. Mean percentage change of VAS scores from baseline in leg pain is reported.|14 days, 6 weeks, 6 months, 12 months, and 24 months|Per-protocol population analysis (subjects who were not performed surgical procedure as assigned per randomization were excluded).||percentage of change from baseline||Standard Deviation|Mean
793551|NCT00905359|Secondary|Patient Satisfaction (PS) Scores of Zurich Claudication Questionnaire|PS score is the mean score of 6 questions of ZCQ, ranging from 1 to 4 if the number of responses exceeded four. A lower score represents a better outcome. Patients with PS score less than 2.5 at postoperative evaluation were considered positive, which implied that patients were satisfied with their treatment.|14 days, 6 weeks, 6 months, 12 months, and 24 months|Per-protocol population analysis (subjects who were not performed surgical procedure as assigned per randomization were excluded).||units on a scale||Standard Deviation|Mean
793552|NCT00905359|Secondary|Mean Percentage of Change From Baseline in Symptom Severity of the Patient Completed Zurich Claudication Questionnaire|ZCQ is a validated outcomes instrument specific to lumbar spinal stenosis, and captures data in 3 distinct domains: SS, PF, and post-treatment PS. SS Score is based on seven questions (overall pain, pain frequency, pain in the back, pain in the leg, numbness, weakness, and balanced disturbance) in ZCQ. The first 6 questions are scored 1 to 5. Balance disturbance is scored in a 1-3-5 scale. The SS score is the mean of all answered items in the questionnaire, ranging from 1 to 5. A lower score represents a better outcome/condition. Mean percentage of change from baseline in Symptom Severity is reported.|14days, 6 week, 6 months, 12 months, 24 months|Per-protocol population analysis (subjects who were not performed surgical procedure as assigned per randomization were excluded).||percentage change from baseline||Standard Deviation|Mean
793553|NCT00905359|Secondary|Mean Percentage Change From Baseline in Physical Function, Using Patient Completed Zurich Claudication Questionnaire|ZCQ is a validated outcomes instrument specific to lumbar spinal stenosis, and captures data in 3 distinct domains: Physical function (PF), Symptom Severity (SS), and post-treatment Patient Satisfaction (PS).PF score is the mean score of five physical function questions of ZCQ, ranging from 1 to 4. A lower score represents a better outcome/condition. Mean percentage change from baseline in Physical Function at 14 days, 6 weeks, 6 months, and 24 months was reported.|14 days, 6 weeks, 6 months, and 24 months|Per-protocol population analysis (subjects who were not performed surgical procedure as assigned per randomization were excluded).||percentage change from baseline||Standard Deviation|Mean
793554|NCT00905359|Primary|Mean Percentage Change From Baseline in Physical Function at 1 Year Follow-up Using the Patient Completed Zurich Claudication Questionnaire|ZCQ is a validated outcomes instrument specific to lumbar spinal stenosis, and captures data in 3 distinct domains: Physical function (PF), Symptom Severity (SS), and post-treatment Patient Satisfaction (PS).PF score is the mean score of five physical function questions of ZCQ, ranging from 1 to 4. A lower score represents a better outcome/condition. Mean percentage change from baseline in Physical Function at 1 year follow-up was reported.|1 year|Per-protocol analysis (subjects who were not performed surgical procedure as assigned per randomization were excluded).||percentage change from baseline||Standard Deviation|Mean
793555|NCT00905424|Secondary|Change From Augmentation Baseline for Remitters in the QIDS-SR Scale Total Score at Week 6|QIDS-SR is a validated, self-reported rating scale that contains 16 items scored on a scale from 0-3 with total scores ranging from 0 (no depression) to 27 (very severe depression). Lower scores indicate less depression.|Augmentation baseline and 6 weeks|FAS||Units on a scale||Standard Error|Least Squares Mean
793556|NCT00905424|Secondary|Change From Augmentation Baseline for Remitters in the MAF Scale Total Score at Week 6|MAF contains 16 items scored on a scale from 1 (not at all) to 10 (a great deal). Answers are converted to a Global Fatigue Index with total scores ranging from 1 (no fatigue) to 50 (severe fatigue). Lower scores indicate less fatigue.|Augmentation baseline and 6 weeks|FAS||Units on a scale||Standard Error|Least Squares Mean
793557|NCT00905424|Secondary|Change From Augmentation Baseline for Remitters in the BRIEF-A Scale Total Score at Week 6|BRIEF-A is a validated 86-item questionnaire composed of three scales (Global Executive Composite, Behavioral Recognition Index, and Metacognition Index). Items are rated 1 (never), 2 (sometimes), and 3 (often). Lower scores reflect better functioning.|Augmentation baseline and 6 weeks|FAS||Units on a scale||Standard Error|Least Squares Mean
793558|NCT00905424|Secondary|Assessment in Remitters of CGI-S at Week 6|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|6 weeks|FAS||Percent of participants|||Number
793559|NCT00905424|Secondary|Assessment in Remitters of CGI-S at Augmentation Baseline|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|Augmentation Baseline|FAS||Percent of participants|||Number
793560|NCT00905424|Secondary|Percentage of Remitters With Improvement on CGI-I at Week 6 - LOCF|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|6 weeks|FAS||Percent of participants|||Number
793561|NCT00905424|Secondary|Change From Augmentation Baseline for Remitters in the SDS Total Score at Week 6|Designed to evaluate the extent to which illness symptoms impact a subject's life in 3 areas: work/school, social, and family/home. Each area is scored on a scale from 0 (no impairment) to 10 (highly impaired) with a total score ranging from 0 (unimpaired) to 30 (highly impaired). Lower scores translate into less impairment.|Augmentation Baseline and 6 weeks|FAS||Units on a scale||Standard Error|Least Squares Mean
793562|NCT00905424|Secondary|Change From Augmentation Baseline for Remitters in the HAM-D Total Score at Week 6 - LOCF|The HAM-D is a validated rating scale which consists of 17 items. Nine of the items are scored on a scale of 0-4 and 8 items are scored on a scale of 0-2 for a total scoring range of 0-52. A score of 0–7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates increased severity of depression. In general, the lower the total score the less severe the depression.|Augmentation Baseline and 6 weeks|FAS||Units on a scale||Standard Error|Least Squares Mean
793563|NCT00905424|Secondary|Change From Augmentation Baseline for Remitters in MADRS Total Score at Week 6 - LOCF|MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression.|Augmentation Baseline and 6 weeks|Full Analysis Set (FAS) defined as all subjects who take at least 1 dose of randomized augmentation treatment and have at least 1 primary efficacy measurement after randomization.||Units on a scale||Standard Error|Least Squares Mean
793603|NCT00907374|Secondary|Carotid Artery Intima Thickness|Thickness of intima of right carotid artery; average of all particpants from 6-36 months of study|6 to 36 months|Completers||mm||Standard Deviation|Mean
793564|NCT00905424|Secondary|Change From Augmentation Baseline for Non-Remitters in the Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR) Scale Total Score at Week 6|QIDS-SR is a validated, self-reported rating scale that contains 16 items scored on a scale from 0-3 with total scores ranging from 0 (no depression) to 27 (very severe depression). Lower scores indicate less depression.|Augmentation Baseline and 6 weeks|Primary Efficacy Analysis Set||Units on a scale||Standard Error|Least Squares Mean
793565|NCT00905424|Secondary|Change From Augmentation Baseline for Non-Remitters in the Multidimensional Assessment of Fatigue (MAF) Scale Total Score at Week 6|MAF contains 16 items scored on a scale from 1 (not at all) to 10 (a great deal). Answers are converted to a Global Fatigue Index with total scores ranging from 1 (no fatigue) to 50 (severe fatigue). Lower scores indicate less fatigue.|Augmentation Baseline and 6 weeks|Primary Efficacy Analysis Set||Units on a scale||Standard Error|Least Squares Mean
793566|NCT00905424|Secondary|Change From Augmentation Baseline for Non-Remitters in the Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A) Scale Total Score at Week 6|BRIEF-A is a validated 75-item questionnaire composed of three scales (Global Executive Composite, Behavioral Recognition Index, and Metacognition Index). Items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to develop interpretive reports. Lower scores reflect better functioning.|Augmentation Baseline and 6 weeks|Primary Efficacy Analysis Set||Units on a scale||Standard Error|Least Squares Mean
793567|NCT00905424|Secondary|Assessment in Non-Remitters of Clinical Global Impression-Severity of Illness (CGI-S) at Week 6|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|6 weeks|Primary Efficacy Analysis Set||Percent of participants|||Number
793568|NCT00905424|Secondary|Assessment in Non-Remitters of Clinical Global Impression-Severity of Illness (CGI-S) at Augmentation Baseline|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|Augmentation baseline|Primary Efficacy Analysis Set||Percent of participants|||Number
793569|NCT00905424|Secondary|Percentage of Non-Remitters With Improvement on Clinical Global Impression-Improvement (CGI-I) at Week 6 - LOCF|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|6 weeks|Primary Efficacy Analysis Set||Percent of Participants|||Number
793570|NCT00905424|Secondary|Change From Augmentation Baseline for Non-Remitters in the Sheehan Disability Scale (SDS) Total Score at Week 6|Designed to evaluate the extent to which illness symptoms impact a subject's life in 3 areas: work/school, social, and family/home. Each area is scored on a scale from 0 (no impairment) to 10 (highly impaired) with a total score ranging from 0 (unimpaired) to 30 (highly impaired). Lower scores translate into less impairment.|Augmentation Baseline, 6 weeks|Primary Efficacy Analysis Set||Units on a scale||Standard Error|Least Squares Mean
793571|NCT00905424|Secondary|Change From Augmentation Baseline for Non-Remitters in the Hamilton Depression Scale (HAM-D) Total Score at Week 6 - LOCF|The HAM-D is a validated rating scale which consists of 17 items. Nine of the items are scored on a scale of 0-4 and 8 items are scored on a scale of 0-2 for a total scoring range of 0-52. A score of 0–7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates increased severity of depression. In general, the lower the total score the less severe the depression.|Augmentation Baseline, 6 weeks|Primary Efficacy Analysis Set||Units on a scale||Standard Error|Least Squares Mean
793572|NCT00905424|Primary|Change From Augmentation Baseline for Non-Remitters in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Total Score at Week 6 - Last Observation Carried Forward (LOCF)|MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression.|Augmentation Baseline, 6 weeks|Primary Efficacy Analysis Set defined as all non-remitters (MADRS total score greater than 10 at augmentation baseline) who take at least 1 dose of randomized augmentation treatment and have at least 1 primary efficacy measurement after randomization.||Units on a scale||Standard Error|Least Squares Mean
793573|NCT00905437|Secondary|Number of Participants With Neuropathic Pain|"ID Pain questionnaire was used to assess neuropathic pain. 6 items questionnaire, did pain feel like: (1)pins and needles (2)hot/burning (3)numb (4)electrical shocks (5)is pain made worse with touch of clothing or bed sheets (6)is pain limited to your joints. Yes response to questions 1-5 were scored as 1, while a yes response to question 6 was scored as -1. No response were scored as 0. Overall score range -1 to 5.Higher score more indicative of pain with a neuropathic component. Number of participants with score 2 or more (which indicated nerve pain) were reported."|Day 90, Day 180 post-surgery|Data was not analyzed as the intended sample size was not met, and the reported numbers from the final set were not sufficient for a meaningful analysis.|||||
793574|NCT00905437|Secondary|Number of Participants With Rescue Medication Usage|Rescue medications were used for participants with moderate or severe resting pain. Fentanyl injection (25 microgram [mcg] intravenous bolus to a maximum dose of 3 milliliter/day), paracetamol tablet (15 milligram/kilogram orally to a maximum dose of 45 milligram/kilogram/day) were used as rescue medications.|Day 0 to Day 6 post-surgery|MITT population included all randomized participants who had at least taken pre-surgery study medication and had no surgical complications.||participants|||Number
793575|NCT00905437|Secondary|Time to Mobilization After Surgery|Participant was encouraged each day (from Day 3) to attempt walking depending upon the degree of pain on standing. The first day on which the participant was able to walk for 5 steps was the day of mobilization. Median time to mobilization (in hours) was calculated till the day of mobilization.|Day 1 to Day 5 post-surgery|MITT population included all randomized participants who had at least taken pre-surgery study medication and had no surgical complications. ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure.||hours||Inter-Quartile Range|Median
793576|NCT00905437|Secondary|Mean Anxiety Visual Analogue Scale (A-VAS)|Mean anxiety visual analogue scale (VAS) was defined as the mean of VAS score on the day of surgery and over Days 1 to 5 post-surgery. Participants measured their degree of anxiety over past 24 hours on a VAS of 0 to 100, where 0 = not at all anxious to 100 = extremely anxious.|Day 0 to Day 5 post-surgery|MITT population included all randomized participants who had at least taken pre-surgery study medication and had no surgical complications. ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure.||Units on a scale||Standard Error|Mean
793577|NCT00905437|Secondary|Mean Daily Sleep Interference Score|Mean daily sleep interference score was defined as the mean of daily sleep interference numeric rating scale (NRS) score over Days 1 to 5 post-surgery. Daily Sleep Interference Scale (DSIS): participant rated pain during past 24-hour period on NRS ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep). Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication.|Day 1 to Day 5 post-surgery|MITT population included all randomized participants who had at least taken pre-surgery study medication and had no surgical complications. ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure.||Units on a scale||Standard Error|Mean
793578|NCT00905437|Secondary|Mean Daily Pain Score|Mean daily pain score was defined as the mean of daily pain score over Days 1 to 7 and Days 8 to 14 post-surgery. Daily Pain Rating Scale (DPRS): participant rated 11-point Likert scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain.|Day 1 to Day 7, Day 8 to Day 14 post-surgery|MITT population included all randomized participants who had at least taken pre-surgery study medication and had no surgical complications. ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure. ‘n’ signifies participants who were evaluable for this measure at specified time-point for each arm.||Units on a scale||Standard Error|Mean
793579|NCT00905437|Primary|Mean Pain on Movement Score|Mean pain on movement score was defined as the mean of the pain on movement score over Days 1 to 5 post-surgery. Pain experienced by participant during passive flexion through 90 degree and passive abduction through 30 degree at operated hip joint was evaluated on a scale of 0 to 10 where, 0= no pain and 10= worst possible pain.|Every 12 hours from Day 1 to Day 5 post-surgery|Modified Intent to Treat (MITT) population included all randomized participants who had at least taken pre-surgery study medication and had no surgical complications. ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure.||Units on a scale||Standard Error|Mean
793580|NCT00905489|Other Pre-specified|Efficacy: Patients Maintaining a VL < 50 Copies/mL at Last Available Visit|Patients maintaining a viral load < 50 copies/mL at the last available visit|Last available visit, up to 155 weeks|Optional Extension Phase Treated Set (OEP TS), all patients that complete PK phase and enroll in Extension phase with VL data available||percentage of patients|||Number
793581|NCT00905489|Secondary|Efficacy: Patients Maintaining a VL < 400 Copies/mL in Optional Extension Phase|Patients maintaining a viral load < 400 copies/mL at week 24 of the Optional Extension Phase (OEP)|week 24|Full analysis set including patients with available viral load data at week 24||percentage of patients|||Number
793582|NCT00905489|Secondary|Efficacy: Patients Maintaining a VL < 50 Copies/mL at Week 24 of Optional Extension Phase|Patients maintaining a viral load < 50 copies/mL at week 24 (approximately 168 days) of Optional Extension Phase (OEP).|week 24|Full analysis set including patients with available viral load data at week 24||percentage of patients|||Number
793583|NCT00905489|Secondary|Percentage Change From Baseline in Mean CD4+ Count|((Day 22 value-Baseline value)/Baseline value)*100. ((Week 24 value-Baseline value)/Baseline value)*100.|Baseline to day 22 and baseline to week 24|Optional Extension Phase Treated Set (OEP TS), all patients that complete PK phase and enroll in Extension phase, and had available data at either day 22 or week 24.||percentage change||Standard Deviation|Mean
793584|NCT00905489|Secondary|Change From Baseline in Mean CD4+ Count (Absolute)|Change in mean CD4+ count (absolute) from baseline to Day 22 and from baseline to Week 24.|Baseline, Day 22 and week 24|PK Analysis set: This patient set includes all patients in the Full Analysis Set (FAS) that have no protocol violations excluding them from PK analysis.||cells/mm^3||Standard Deviation|Mean
793585|NCT00905489|Secondary|Efficacy: Patients Maintaining a VL < 400 Copies/mL|Patients maintaining a viral load < 400 copies/mL at Day 22|Day 22|Full analysis set including patients with available viral load data at day 22||percentage of patients|||Number
793586|NCT00905489|Secondary|Efficacy: Patients Maintaining a VL < 50 Copies/mL|Patients maintaining a viral load < 50 copies/mL at Day 22.|Day 22|Full analysis set including patients with available viral load data at day 22||percentage of patients|||Number
793587|NCT00905489|Secondary|Cavg|Average measured concentration of the Nevirapine in plasma at steady state Patients took Nevirapine (NVP) Immediate Release (IR) up to day 10 and had PK measurements taken on Day 11. This was followed by 9 days (from day 12 to day 20) taking NVP Extended Release (XR) with PK measurements taken on Day 22.|Day 11 prior to the next scheduled dose of Nevirapine IR and day 22 prior to the next scheduled dose of Nevirapine XR|Intensive PK analysis set (IPK): This patient set includes all patients in the PK set that underwent intensive PK sampling.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
793588|NCT00905489|Secondary|CL/F,ss|Apparent clearance of the Nevirapine in the plasma after extravascular administration at steady-state Patients took Nevirapine (NVP) Immediate Release (IR) up to day 10 and had PK measurements taken on Day 11. This was followed by 9 days (from day 12 to day 20) taking NVP Extended Release (XR) with PK measurements taken on Day 22.|Day 11 prior to the next scheduled dose of Nevirapine IR and day 22 prior to the next scheduled dose of Nevirapine XR|Intensive PK analysis set (IPK): This patient set includes all patients in the PK set that underwent intensive PK sampling.||mL/h||Geometric Coefficient of Variation|Geometric Mean
793589|NCT00905489|Secondary|Tmax,ss|"Time from dosing to the maximum concentration of the Nevirapine in plasma at steady state over the time dosing interval τ Patients took Nevirapine (NVP) Immediate Release (IR) up to day 10 and had PK measurements taken on Day 11. This was followed by 9 days (from day 12 to day 20) taking NVP Extended Release (XR) with PK measurements taken on Day 22.
The standard deviation is actually the coefficient of variation."|Day 11 prior to the next scheduled dose of Nevirapine IR and day 22 prior to the next scheduled dose of Nevirapine XR|Intensive PK analysis set (IPK): This patient set includes all patients in the PK set that underwent intensive PK sampling.||hours||Standard Deviation|Mean
793590|NCT00905489|Secondary|%PTF|Percentage peak-trough Nevirapine fluctuation, % fluctuation (degree of peak to trough fluctuation) Patients took Nevirapine (NVP) Immediate Release (IR) up to day 10 and had PK measurements taken on Day 11. This was followed by 9 days (from day 12 to day 20) taking NVP Extended Release (XR) with PK measurements taken on Day 22.|Day 11 prior to the next scheduled dose of Nevirapine IR and day 22 prior to the next scheduled dose of Nevirapine XR|Intensive PK analysis set (IPK): This patient set includes all patients in the PK set that underwent intensive PK sampling.||percentage fluctuation||Geometric Coefficient of Variation|Geometric Mean
793591|NCT00905489|Secondary|Ratio Cmax,ss/Cmin,ss|Ratio of (maximum measured concentration of the Nevirapine in plasma at steady state over the time dosing interval τ)/(minimum measured concentration of the analyte in plasma at steady state over the time dosing interval τ) Patients took Nevirapine (NVP) Immediate Release (IR) up to day 10 and had PK measurements taken on Day 11. This was followed by 9 days (from day 12 to day 20) taking NVP Extended Release (XR) with PK measurements taken on Day 22.|Day 11 prior to the next scheduled dose of Nevirapine IR and day 22 prior to the next scheduled dose of Nevirapine XR|Intensive PK analysis set (IPK): This patient set includes all patients in the PK set that underwent intensive PK sampling.||Ratio||Geometric Coefficient of Variation|Geometric Mean
793592|NCT00905489|Secondary|Cmax,ss (for IR and XR Formulations by Nevirapine XR Dose Group)|Maximum measured concentration of the Nevirapine in plasma at steady state over the time dosing interval τ Patients took Nevirapine (NVP) Immediate Release (IR) up to day 10 and had PK measurements taken on Day 11. This was followed by 9 days (from day 12 to day 20) taking NVP Extended Release (XR) with PK measurements taken on Day 22.|Day 11 prior to the next scheduled dose of Nevirapine IR and day 22 prior to the next scheduled dose of Nevirapine XR|Intensive PK analysis set (IPK): This patient set includes all patients in the PK set that underwent intensive PK sampling.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
793593|NCT00905489|Secondary|Cmin,ss (for IR and XR Formulations by Nevirapine XR Dose Group)|Minimum measured concentration of the Nevirapine in plasma at steady state over the time dosing interval τ by nevirapine XR dose group Patients took Nevirapine (NVP) Immediate Release (IR) up to day 10 and had PK measurements taken on Day 11. This was followed by 9 days (from day 12 to day 20) taking NVP Extended Release (XR) with PK measurements taken on Day 21.|Day 11 prior to the next scheduled dose of Nevirapine IR and day 22 prior to the next scheduled dose of Nevirapine XR|Intensive PK analysis set (IPK): This patient set includes all patients in the PK set that underwent intensive PK sampling.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
793594|NCT00905489|Secondary|AUCt,ss|"Area under the concentration-time curve of the Nevirapine (NVP) in plasma at steady state over the time dosing interval τ.
All patients received nevirapine IR for 10 days prior to collection of 12-hour Area Under the Curve (AUC) data. Then, all patients were switched to nevirapine XR for 9 days prior to collection of 24-hour AUC data. The treatments of IR and XR are summarized separately using geometric means and geometric coefficients of variation.
For NVP IR AUC measured over hours: 0,1,2,3,4,8 and 12, For NVP XR AUC measured over hours: 0,1,2,3,4,8,10,12 and 24."|Day 11 prior to the next scheduled dose of Nevirapine IR and day 22 prior to the next scheduled dose of Nevirapine XR|Intensive PK analysis set (IPK): This patient set includes all patients in the PK set that underwent intensive PK sampling.||ng*h/ml||Geometric Coefficient of Variation|Geometric Mean
793595|NCT00905489|Primary|Trough Cpre,N.|"Trough Nevirapine concentration immediately prior to the next scheduled dose. Patients took Nevirapine (NVP) Immediate Release (IR) up to day 10 and had PK measurements taken on Day 11. This was followed by 9 days (from day 12 to day 20) taking NVP Extended Release (XR) with PK measurements taken on Day 22.
The measure of dispersion presented is the coefficient of variation (%) rather than the geometric coefficient of variation."|Day 11 prior to the next scheduled dose of Nevirapine IR and day 22 prior to the next scheduled dose of Nevirapine XR|PK analysis set (PKS): This patient set includes all patients in the Full Analysis Set (FAS) set that have no protocol violations excluding them from PK analyses.||(ng/mL/mg)||Geometric Coefficient of Variation|Geometric Mean
793596|NCT00907335|Secondary|Global Assessment|Participants showing improvement from baseline in the Investigator’s Global Assessment, in the Intent to Treat population using the Last Available Measurement and imputation technique of Last Observation Carried Forward, rating the subject’s improvement over Baseline by using the following categories: Excellent, Good, Fair, No Change, Worse.|Baseline to Week 12|||Participants|||Number
793597|NCT00907335|Secondary|Measurement of Success 3|Participants achieving success according to Investigator Global Assessment (IGA#3) scores. At Week 12, the IGA #3 rated the subject’s improvement over Baseline by using the following categories: Excellent, Good, Fair, No Change, Worse. The number of participants for which treatment was considered successful was based on the IGA #3 success criteria defined as achievement of “Excellent” or “Good” scores.|Week 12|||Participants|||Number
793598|NCT00907335|Secondary|Measurement of Success 2|Participants achieving success according to dichotomized Investigator Global Assessment (IGA) scores - Food and Drug Administration Score (IGA#2) The IGA #2 (static 5 point scale recommended in the FDA acne guidelines) has ordinal response categories identified as clear (0), almost clear (1), mild (2), moderate (3), and severe (4). The number of participants for which treatment was considered successful was based on 2 criteria: 1) improvement by at least 2 grades from the baseline score, and 2) ratings of clear or almost clear.|Week 12|||Participants|||Number
793599|NCT00907335|Secondary|Measurement of Success 1|Participants achieving success according to the Investigator Global Assessment (IGA #1) - (Pediatric Acne Scale) has ordinal response categories identified as clear (0), almost clear (1), mild (2), moderate (3), severe (4), and very severe (5). The number of participants for which treatment was considered successful was based on 2 criteria: 1) improvement by at least 2 grades from the baseline score, and 2) ratings of clear or almost clear.|Week 12|||Participants|||Number
793600|NCT00907335|Secondary|Change From Baseline in Lesion Counts|Change from baseline in Lesion Count by the following categories: Facial acne lesion counts consisted of non-inflammatory lesions and inflammatory lesions. Inflammatory lesions were the sum of papules and pustules. Total lesions were the sum of non-inflammatory and inflammatory lesions, plus nodules/cysts. For each lesion type, change from Baseline was calculated as the value after Baseline minus the baseline value, and negative changes indicated lesion improvement.|Baseline to Week 12|||Lesions||Standard Error|Least Squares Mean
793601|NCT00907335|Primary|Change From Baseline in Total Non-inflammatory Lesion Count|Change from Baseline to Week 12 (Week 12 minus Baseline) in the total non-inflammatory acne lesion count. Facial acne lesion counts consisted of non-inflammatory lesions and inflammatory lesions. The total non-inflammatory acne lesion count is the sum of open and closed comedones, change from Baseline was calculated as the value after Baseline minus the baseline value, and negative changes indicated lesion improvement.|Baseline to Week 12|||Lesions||Standard Error|Least Squares Mean
793602|NCT00907374|Secondary|Endothelial Dysfunction|Post hyperemia increase in blood flow - fold increase from before and after occluding BP; values are mean of all participants in 6-36 months of study period.|6 to 36 months|complerters||Fold increase||Standard Deviation|Mean
793606|NCT00907426|Other Pre-specified|Percentage of Subjects With at Least a 1-Grade Improvement in Global Eyelash Assessment (GEA) Score at Month 4|Percentage of subjects with at least a 1-grade improvement in GEA score at Month 4. The GEA scale is an investigator-graded 4-point scale of overall eyelash prominence where 1=minimal, 2=moderate, 3=marked, and 4=very marked prominence.|Month 4|Intent-to-Treat: All randomized subjects who had baseline and Month 4 data collected for this outcome measure||Percentage of Participants|||Number
793607|NCT00907426|Secondary|Change From Baseline in Upper Eyelash Darkness at Month 4|Change from baseline in upper eyelash darkness at Month 4 was determined by lash intensity within the spline (a narrow area approximately 5 pixels wide that bisects the area of interest). Upper eyelash darkness was measured in both eyes and averaged for analysis. Colors ranged from black=0 to white=255. Lower numbers on this continuum indicated darker colors. A negative number value change from baseline indicated increased eyelash darkening.|Baseline, Month 4|Intent-to-Treat: All randomized subjects who had baseline and Month 4 data collected for this outcome measure||Eyelash Intensity Units||Standard Deviation|Mean
793608|NCT00907426|Secondary|Change From Baseline in Average Progressive Upper Eyelash Thickness at Month 4|Change from baseline in average progressive upper eyelash thickness at Month 4 was measured within 3 preset areas. Eyelash thickness was assessed across both eyes as an average of the 3 preset areas measured in millimeters squared (mm^2). Changes from baseline at Month 4 represented by positive values indicated increased eyelash thickness, and changes from baseline represented by negative values indicated thinner eyelash thickness.|Baseline, Month 4|Intent-to-Treat: All randomized subjects who had baseline and Month 4 data collected for this outcome measure||Millimeters squared (mm^2)||Standard Deviation|Mean
793609|NCT00907426|Secondary|Change From Baseline in Upper Eyelash Length at Month 4|Change from Baseline to in upper eyelash length at Month 4, measured in millimeters (mm). Data from both eyes were averaged for each subject for analysis. Changes from baseline represented by positive values indicated longer length, and changes from baseline represented by negative values indicated shorter length.|Baseline, Month 4|Intent-to-Treat: All randomized subjects who had baseline and Month 4 data collected for this outcome measure||Millimeters (mm)||Standard Deviation|Mean
793610|NCT00907426|Primary|Percentage of Treatment Responders at Month 4|Percentage of Treatment Responders at Month 4 defined by: a) at least a 1-grade improvement from baseline in the Global Eyelash Assessment (GEA) score, AND b) at least a 3-point improvement from baseline in the total score for Domain 2 of the Eyelash Symptom Questionnaire (ESQ). The GEA 4-point scale assessed eyelash prominence from 1 (minimal) to 4 (very marked). Domain 2 of the ESQ assessed subjective attributes of confidence, attractiveness, and professionalism rated on a 5-point scale from 1 (very much disagree) to 5 (very much agree) for a total score between 3 and 15.|Month 4|Intent-to-Treat: All randomized subjects||Percentage of Subjects|||Number
793611|NCT00907478|Secondary|Number of Participants Who Developed Antibodies or Neutralizing Antibodies to Romiplostim or to Endogenous Thrombopoietin|"Two validated assays were used to test for antibodies to romiplostim, the thrombopoietin-mimetic peptide component of romiplostim (TMP) and to endogenous thrombopoietin (TPO). The first was an immunoassay to confirm the presence of antibodies. The second was a cell-based bioassay to detect neutralizing or inhibitory effects in vitro. If a sample was positive in both assays, a participant was defined as positive for neutralizing antibodies.
Persistent antibodies were those positive at the last timepoint tested and transient are defined as positive post-dose but negative at the last time point tested."|Every 24 weeks and at the end of study visit (4 weeks or 12 weeks after study drug discontinuation).|All participants who received at least one dose of romiplostim.||participants|||Number
793612|NCT00907478|Secondary|Number of Participants With Adverse Events (AEs)|An AE was defined as any untoward medical occurrence in a participant that did not necessarily have a causal relationship with this treatment, or any such occurrence or worsening of a pre-existing medical condition from the first dose of investigational product through the last study visit. A serious adverse event is defined as an AE that is fatal or life threatening, requires or prolongs hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or other significant medical hazard. The relationship of each AE to the study drug was assessed by the investigator. The severity of each AE was graded using using CTCAE 3.0; For any AEs not listed in CTCAE, the Amgen Standard Severity Scoring System was used: 1: Mild- Aware of sign or symptom, but easily tolerated; 2 Moderate- Discomfort enough to cause interference with usual activity; 3: Severe- Incapacitating with inability to work or do usual activity; 4: Life-threatening; 5: Fatal.|From the first dose of study drug until 4 weeks after treatment discontinuation or 12 weeks after treatment discontinuation for patients who developed collagen fibrosis or a change to grade 3 reticulin; the overall median treatment duration was 154 weeks.|All participants who received at least one dose of romiplostim||participants|||Number
793613|NCT00907478|Secondary|Percentage of Participants With CTCAE Grade ≥ 2 Shift in Anemia or Neutropenia|Anemia was identified by laboratory values with hemoglobin < the lower limit of normal (LLN) or the Medical Dictionary for Regulatory Activities (MedDRA) terms prespecified by the sponsor. Neutropenia was identified by laboratory values with absolute neutrophil count <1.8x10^9/L or the MedDRA terms pre-specified by the sponsor. Severity was assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, based on the following: Grade 1: Mild AE; Grade 2: Moderate AE; Grade 3: Severe AE; Grade 4: Life-threatening or disabling AE; Grade 5: Death related to AE.|From the first dose of study drug until 4 weeks after treatment discontinuation or 12 weeks after treatment discontinuation for patients who developed collagen fibrosis or a change to grade 3 reticulin; the overall median treatment duration was 154 weeks.|All participants who received at least one dose of romiplostim||percentage of participants||95% Confidence Interval|Number
793624|NCT00907738|Primary|Percent of Participants With a Serious Drug-related Adverse Event (AE)|"A serious adverse event (SAE) was any AE occurring at any dose that resulted in death, was life-threatening, resulted in a persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a cancer, or was an overdose.
A drug-related SAE was one that was thought to be possibly, probably, or definitely related to the study drug."|From the first dose of study drug until the patient experiences disease progression, withdraws consent, or develops unacceptable toxicity (from Day 1 up to 4 years and 9 months)|||percent of participants|||Number
793842|NCT00909753|Primary|AUC0-72 - Area Under the Concentration-time Curve From Time Zero to 72 Hours Post Dose - for Total Ursodiol|Bioequivalence based on AUC0-72|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
793614|NCT00907478|Secondary|Number of Participants With Improvement of Reticulin to a Grade of ≤ 2 for Participants Who Developed Grade 3 Reticulin|The number of participants who had any improvement of reticulin to a grade of ≤ 2 for participants who developed grade 3 reticulin after initial exposure to romiplostim as measured by the modified Bauermeister grading scale. The modified Bauermeister scale provides a means of assessing the development of increased reticulin and collagen in bone marrow according to the following: Grade 0: No reticulin fibers demonstrable; Grade 1: Occasional fine individual fibers and foci of a fine fiber network; Grade 2: Fine fiber network throughout most of the section; no coarse fibers; Grade 3: Diffuse fiber network with scattered thick coarse fibers but no mature collagen (negative to trichrome staining); Grade 4: Diffuse, often course fiber network with areas of collagenization (positive trichrome staining).|12 weeks after romiplostim discontinuation|Participants with Grade 3 reticulin at Year 1, 2 or 3 and who had a follow-up bone marrow biopsy 12 weeks after romiplostim discontinuation. Two participants with grade 3 reticulin did not have a bone marrow biopsy performed 12 weeks after romiploastim discontinuation.||participants|||Number
793615|NCT00907478|Secondary|Percentage of Participants With Clinically Relevant Changes in Total Cardiac Output Corrected (QTc) Intervals|A clinically relevant change in QTc (Fridericia) interval is defined as an absolute QTc interval >500 ms or a QTc Interval increase from Baseline >60 ms post romiplostim exposure. 12-lead electrocardiograms (ECG) were performed in triplicate at Baseline, Week 3 and Week 12; the average of of the 3 values at each assessment was used.|Baseline, Week 3 and Week 12|All participants who received at least one dose of romiplostim.||percentage of participants||95% Confidence Interval|Number
793616|NCT00907478|Secondary|Percentage of Participants Who Developed an Increased Modified Bauermeister Grade|Increased modified Bauermeister grade refers to an increase by ≥ 2 severity grades or an increase to grade 4 (ie, grade 0 to 2-4, grade 1 to 3-4, grade 2 to 4, or grade 3 to 4 over baseline). The modified Bauermeister scale provides a means of assessing the development of increased reticulin and collagen in bone marrow according to the following: Grade 0: No reticulin fibers demonstrable; Grade 1: Occasional fine individual fibers and foci of a fine fiber network; Grade 2: Fine fiber network throughout most of the section; no coarse fibers; Grade 3: Diffuse fiber network with scattered thick coarse fibers but no mature collagen (negative to trichrome staining); Grade 4: Diffuse, often course fiber network with areas of collagenization (positive trichrome staining).|At Year 1, Year 2, or Year 3 post romiplostim exposure|Participants who had evaluable reticulin silver stain results||percentage of participants||95% Confidence Interval|Number
793617|NCT00907478|Secondary|Number of Participants With Collagen Fibrosis 12 Weeks After Romiplostim Discontinuation in Participants Who Developed Collagen Fibrosis at Years 1, 2, or 3|The number of participants with collagen fibrosis as evidenced by trichrome staining 12 weeks after romiplostim discontinuation in participants who developed collagen fibrosis at Years 1, 2, or 3 after initial exposure of romiplostim, assessed by the central laboratory using the modified Bauermeister grading scale.|12 weeks after romiplostim discontinuation|Participants with collagen fibrosis at Year 1, 2 or 3 and with available trichome staining results 12 weeks after study drug discontinuation. One participant with collagen fibrosis refused the follow-up bone marrow biopsy.||participants|||Number
793618|NCT00907478|Primary|Percentage of Participants With Collagen Fibrosis|The percentage of participants who developed collagen fibrosis as evidenced by trichrome staining. Bone marrow biopsy samples were assessed using the modified Bauermeister grading scale by a central laboratory.|At Years 1, 2 or 3 after initial exposure of romiplostim|Participants who had evaluable trichrome stain results||percentage of participants||95% Confidence Interval|Number
793619|NCT00907517|Primary|Number of Participants Who Discontinued Study Treatment Due to an AE|An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a study treatment, whether or not considered related to this study treatment. The number of participants who discontinued study treatment due to an AE is summarized.|Up to 135 days|The population consisted of all participants who received at least one dose of study treatment.||Participants|||Number
793620|NCT00907517|Primary|Number of Participants Who Experienced an Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a study treatment, whether or not considered related to this study treatment. The number of participants who experienced an AE is summarized.|Up to 45 days after last dose of study treatment (Up to 180 days)|The population consisted of all participants who received at least one dose of study treatment.||Participants|||Number
793621|NCT00907517|Primary|Number of Participants Who Experienced a Dose-limiting Toxicity (DLT)|Toxicity was assessed according to the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v 3.0). DLTs in Cycle 1 consisted of any of the following: 1) Selected Grade 4 drug-related nonhematologic toxicities, 2) Selected Grade 3 drug-related nonhematologic toxicities that do not resolve to ≤ Grade 2 within 48 hours: Neurotoxicity of any duration, Nephrotoxicity of any duration, QT interval corrected by Fridericia (QTcF) prolongation of any duration, 3) Inability to administer Day 10 cytarabine therapy due to ongoing, uncontrolled serious or life-threatening toxicity. The number of participants who experienced a DLT during Cycle 1 is summarized.|Throughout Cycle 1 (Up to 6 weeks)|The population consisted of all participants who received at least one dose of study treatment.||Participants|||Number
793622|NCT00907621|Secondary|Parents Evaluation of Benefit to the Child.|"Parents subjective assessment of the childs condition, on a 5 point scale, with 1 being worse and 5 being completely well.
The numbers are the actual evaluations on the time specified."|5 days, 1 , and 4 weeks after the first treatment|The differences in numbers on parents evaluation of the childs condition (37 and 38) is due to one location assistant not reporting back on these results. Thus the number of interviews, 84, and secondary outcome data is not consistent with the numbers in the flow diagram.||units on a scale||Standard Deviation|Mean
793623|NCT00907621|Primary|Change in Crying Time Per 24 Hour Period.|Crying time per 24 hour period at baseline and post treatment|6 time points measured: First, second and third intervention day, one day after last intervention, one week after last intervention and one month after last intervention. All time points measured in 24 hours.|||minutes crying time pr 24 hour||95% Confidence Interval|Mean
793625|NCT00907777|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or may evolve into one of the outcomes listed above.|Throughout the entire study period (approximately 1 month per subject)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the additional vaccine administration documented.||Subjects|||Number
793626|NCT00907777|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. “Any” is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.|Within 31 days (Day 0-30) post-additional vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the additional vaccine administration documented.||Subjects|||Number
793627|NCT00907777|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms assessed include drowsiness, fever (defined as rectal temperature ≥ 38.0°C), irritability, and loss of appetite. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectal temperature) above (>) 40.0 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal everyday activities. Grade 3 loss of appetite was defined as the subject not eating at all. “Any” is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination.|During the 8-day (Days 0-7) post-additional dose|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the additional vaccine administration documented.||Subjects|||Number
793628|NCT00907777|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms|"Solicited general symptoms assessed include pain, redness, and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger (>) 30 millimeters (mm). Any is defined as incidence of the specified symptom regardless of intensity."|During the 8-day (Days 0-7) post-additional dose|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the additional vaccine administration documented.||Subjects|||Number
793629|NCT00907777|Secondary|Anti-protein D Antibody Concentrations|The anti-protein D antibody cut-off value (greater than or equal to ≥100 EL.U/mL) was assessed by Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per milliliter (EL.U/mL).|Before (PRE) and one month after (POST) the additional dose|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity endpoint measures were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
793630|NCT00907777|Secondary|Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes|The opsonophagocytic activity cut-off value assessed was greater than or equal to ≥ 8. The cross-reactive pneumococcal serotypes assessed include 6A and 19A.|Before (PRE) and one month after (POST) the additional dose|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity endpoint measures were available.||Titers||95% Confidence Interval|Geometric Mean
793631|NCT00907777|Secondary|Cross-reactive Pneumococcal Serotype Antibody Concentrations|The anti-pneumococcal antibody concentration cut-off value assessed was greater than or equal to ≥ 0.05 microgram per milliliter (μg/mL). The cross-reactive pneumococcal serotypes assessed include 6A and 19A.|Before (PRE) and one month after (POST) the additional dose|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity endpoint measures were available.||microgram/milliliter||95% Confidence Interval|Geometric Mean
793632|NCT00907777|Secondary|Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes|The opsonophagocytic activity cut-off value assessed was greater than or equal to ≥ 8. The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.|Before (PRE) and one month after (POST) the additional dose|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity endpoint measures were available.||Titers||95% Confidence Interval|Geometric Mean
793633|NCT00907777|Primary|Vaccine Pneumococcal Serotype Antibody Concentrations|The anti-pneumococcal antibody concentration cut-off value assessed was greater than or equal to ≥ 0.05 microgram per milliliter (μg/mL). The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.|Before (PRE) and one month after (POST) the additional dose|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity endpoint measures were available.||microgram/milliliter||95% Confidence Interval|Geometric Mean
793634|NCT00907803|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: t½|t½: Observed terminal elimination half-life determined after the last dose on Day 14|Day 14 post-dose|As per protocol. All 16 subjects in the placebo group were excluded from the PK population. In addition, 21 and 20 subjects in the ST-246 400 mg and 600 mg groups respectively, were excluded from PK analysis due to early withdrawals or because PK data fell below the limit of quantitation (BLQ).||hours||Standard Deviation|Mean
793635|NCT00907803|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: AUCtau|AUCtau: Area under the plasma concentration-time curve for each dosing interval (from time 0 to 24 hours sample) determined using the linear trapezoidal rule|Day 14 post-dose|As per protocol. All 16 subjects in the placebo group were excluded from the PK population. In addition, 5 and 6 subjects in the ST-246 400 mg and 600 mg groups respectively, were excluded from PK analysis due to withdrawals or because PK data fell below the limit of quantitation (BLQ).||ng*hr/mL||Standard Deviation|Mean
793636|NCT00907803|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: AUCtau|AUCtau: Area under the plasma concentration-time curve for each dosing interval (from time 0 to 24 hours sample) determined using the linear trapezoidal rule|Day 1 post-dose|As per protocol. All 16 subjects in the placebo group were excluded from the PK population. In addition, 23 subjects in each of the ST-246 400 mg and 600 mg groups were excluded from PK analysis due to early withdrawals or because PK data fell below the limit of quantitation (BLQ) before the 24-hour dosing interval was complete.||ng*hr/mL||Standard Deviation|Mean
793843|NCT00909753|Primary|Cmax - Maximum Observed Concentration - for Total Ursodiol|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.||ng/mL||Standard Deviation|Mean
793637|NCT00907803|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: Tmax|Tmax: Time to reach maximum drug concentration in plasma calculated from [plasma] versus time profiles|Day 14 post-dose|As per protocol. All 16 subjects in the placebo group were excluded from the PK population. In addition, 4 and 5 subjects in the ST-246 400 mg and 600 mg groups respectively, were excluded from PK analysis due to withdrawals or because PK data fell below the limit of quantitation (BLQ).||hours||Standard Deviation|Mean
793638|NCT00907803|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: Tmax|Tmax: Time to reach maximum drug concentration in plasma calculated from [plasma] versus time profiles|Day 1 post-dose|As per protocol. All 16 subjects in the placebo group were excluded from the PK population. In addition, 2 subjects in each of the ST-246 400 mg and 600 mg groups were excluded due to early withdrawals.||hours||Standard Deviation|Mean
793639|NCT00907803|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: Cmax|Cmax: Maximum drug concentration in plasma determined directly from individual concentration-time data|Day 14 post-dose|As per protocol. All 16 subjects in the placebo group were excluded from the PK population. In addition, 4 subjects in each of the ST-246 400 mg and 600 mg groups were excluded from PK analysis due to withdrawals or because PK data fell below the limit of quantitation (BLQ).||ng/mL||Standard Deviation|Mean
793640|NCT00907803|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: Cmax|Cmax: Maximum drug concentration in plasma determined directly from individual concentration-time data|Day 1 post-dose|As per protocol. All 16 subjects in the placebo group were excluded from the PK population. In addition, 2 subjects in each of the ST-246 400 mg and 600 mg groups were excluded due to early withdrawals.||ng/mL||Standard Deviation|Mean
793641|NCT00907803|Primary|Number of Study Participants Who Tolerated a Single Daily Oral ST-246 Dose as Determined by Safety Parameter Changes According to the DAIDS (Division of Acquired Immunodeficiency Syndrome) Adverse Events (AE) Grading Table.|Subjects were administered a single, daily oral dose of ST-246 (400 or 600 mg)and changes in safety parameteres were monitored. Safety parameters included adverse events, vital signs, physical examinations, laboratory tests (hematology, blood chemistry, and urinalysis) and electrocardiograms. The DAIDS AE grading table is a list of common terms and severity (intensity) of parameters used to describe adverse events occurring in NIAID-sponsored clinical studies/trials.|Days 1 to 14; then 24, 48, 72, 96 and 120 hours and 4 weeks after final dose|As per protocol. During the study, a total of 6 withdrawals occurred. These were due to adverse events (2) and consent withdrawal (1) in the 400 mg group, and subject request (1), lost to follow-up (1) and protocol violation (1) in the 600 mg group.||Participants|||Number
793642|NCT00907881|Secondary|Correlation Between HbA1c Values at Baseline and Hypoglycemia Scores at Week 12|Coefficient of correlation as measured using linear regression analysis for association between two variables, HbA1c values at baseline and hypoglycemia scores. A positive correlation coefficient indicates that as one value increases the other value increases, or as as one value decreases the other value decreases.|Baseline and Week 12|All enrolled participants with available data at both Baseline and Week 12.||Correlation coefficient|||Number
793643|NCT00907881|Secondary|Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores by Sub-group (Demographic/Disease Parameters)|Sub-group analyses based on Karl pearson coefficient of correlation for HbA1c values at Week 12 and hypoglycemia score. Participants were grouped based on gender, age, body mass index, and duration of diabetes. A negative correlation coefficient indicates that as one value increases the other value decreases, and vice versa.|Week 12|||Correlation coefficient|||Number
793644|NCT00907881|Secondary|Hypoglycemia Symptom Score by Sub-group (Demographic/Disease Parameters)|Sub-group analyses of mean hypoglycemia symptom score. Participants were grouped based on gender, age, hypoglycemia severity, body mass index, duration of diabetes, and number of oral hypoglycemic agents. Hypoglycemia symptom score (measured by Stanford Hypoglycemia Questionnaire) is a score on a scale with a possible range of 0 (best) to 7 (worst). The questionnaire was administered by the physician at Week 12.|Week 12|Evaluable population defined as all enrolled participants who completed the study and had the values for HbA1c at Week 12 and Stanford Hypoglycemia Score without any major protocol deviation.||Score on a scale||Standard Deviation|Mean
793645|NCT00907881|Primary|Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores|Coefficient of correlation was measured using a linear regression analysis for the association between two variables, HbA1c values at Week 12 and hypoglycemia scores. A negative correlation coefficient indicates that as one value increases the other value decreases, and vice versa.|Week 12|Evaluable population defined as all enrolled participants who completed the study and had the values for HbA1c at Week 12 and Stanford Hypoglycemia Score without any major protocol deviation.||Correlation coefficient||95% Confidence Interval|Number
793646|NCT00907907|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.||µg*hr/mL||Standard Deviation|Mean
793647|NCT00907907|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.||µg*hr/mL||Standard Deviation|Mean
793648|NCT00907907|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.||µg/mL||Standard Deviation|Mean
793649|NCT00908011|Secondary|Assessment of Safety Parameters, Specifically Incidence of Complications as Measured by an Increase in AST &/or ALT ≥3-fold ULN & a CK ≥10-fold ULN||3 months from baseline||||||
793650|NCT00908011|Secondary|Percent Change in Apolipoprotein B, Percent and Absolute Change Total Cholesterol, LDL, HDL, Triglycerides, Apolipoprotein A1, apolipoproteinB/apoliporoteinA1 Ratio and C-reactive Protein||3 months from baseline||||||
793651|NCT00908011|Primary|The Primary Endpoint is the Difference in Final Value of Serum Apolipoprotein B Between Participants Treated With Rosuvastatin Versus Participants Treated With Both Rosuvastatin and Ezetimibe.||3 months from baseline|||mmol/L||Standard Deviation|Mean
793716|NCT00908583|Secondary|Acute Rejection Rate|Acute rejection rate at 6 months of all desensitized and transplanted patients|6 months post transplant|One graft loss occurred due to graft thrombosis within 24 hours (due to unrecognized hypercoagulability disorder without AMR). Two patients were transplanted at other centers and data was not available. This dropped the number of analyzed patients to 16 from 19.||participants|||Number
793652|NCT00908037|Secondary|Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts|"The visual acuity assessment was performed by an ophthalmologist or an optometrist under the guidance of an ophthalmologist. Visual acuity is defined as acuteness or clearness of vision. Number of participants with a change in visual acuity and change in visual acuity due to the worsening of cataracts since Baseline are presented for Part 2/3 Follow-up Visits at 3-months (FU3) and 6-months (FU6). Change in visual acuity since Baseline is displayed under the left eye but applies to both eyes. Change in visual acuity (VA) is categorized as yes or no. Change due to cataracts is categorized as yes or no."|BL, 3 and 6mo Follow-up of Part 2/3|Safety Population: all subjects who have received at least one dose of the investigational product during Part 2/3 were analyzed.||Participants|||Number
793653|NCT00908037|Secondary|Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts During Part 1|"The visual acuity assessment was performed by an ophthalmologist or an optometrist under the guidance of an ophthalmologist. Visual acuity is defined as acuteness or clearness of vision. The number of participants with a change in visual acuity and worsening visual acuity due to cataracts since Baseline are presented for Part 1 Follow-up Visits at 3-months (FU3) and at 6-months (FU6). Change in visual acuity since Baseline is displayed under the left eye but applies to both eyes. Change in visual acuity (VA) is categorized as yes or no. Change due to cataracts is categorized as yes or no."|Baseline, 3and 6-mo Follow-up of Part 1|Safety Population: all subjects who have received at least one dose of the investigational product during Part 1 were analyzed.||Participants|||Number
793654|NCT00908037|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During Part 2/3|An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect. Medical or scientific judgment should be exercised in other situations.|From Treatment + 1 day up to Week 31 of Part2/3|Safety Population: all participants who received at least one dose of the investigational product during Part 2/3 were analyzed||Participants|||Number
793655|NCT00908037|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During Part 2|An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect. Medical or scientific judgment should be exercised in other situations.|From Treatment + 1 day up to Week 7 of Part 2|Safety Population: all participants who received at least one dose of the investigational product during Part 2 were analyzed.||Participants|||Number
793656|NCT00908037|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During Part 1|An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect. Medical or scientific judgment should be exercised in other situations.|From Treatment + 1 day up to Week 24 of Part1|Safety Population: all participants who received at least one dose of the investigational product during Part 1 were analyzed.||Participants|||Number
793657|NCT00908037|Secondary|Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3|Urinalysis parameters included: urine protein (UP), urine glucose (UG), urine ketones (UK), urine occult blood (UOB), and pH. The dipstick test gives results in a semi-quantitative manner. UP was categorized as missing (MS), no result (NR), negative (Neg), Trace, 1+, 2+, 3+ and 4+. UG results were categorized as MS, NR, Neg, normal, 5, 15(1+), 30(2+), 60(3+), 110(4+)UK parameters were categorized as as MS, NR, Neg, Trace(5), Small(15), Moderate(40), Large(80), Large(160). UOB parameters were categorized as MS, NR, Neg, 1+, 2+, 3+, Non haemolysed trace, and haemolysed trace. PH results were categorized as MS. NR, normalresult, Neg, and range of pH (from 5-9in increments of 0.5). Data for indicated parameters was reported at Baseline (BL) and Week 24 (W24). The Baseline value was the measurement taken at Day 1.|Baseline and Week 24 of Part 2/3 up to Study Week 31|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population||Participants|||Number
793658|NCT00908037|Secondary|Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2|Urinalysis parameters included: urine protein (UP), urine glucose (UG), urine ketones (UK), urine occult blood (UOB), and pH. The dipstick test gives results in a semi-quantitative manner. UP was categorized as missing (MS), no result (NR), negative (Neg), Trace, 1+, 2+, 3+ and 4+. UG results were categorized as MS, NR, Neg, normal, 5, 15(1+), 30(2+), 60(3+), 110(4+)UK parameters were categorized as as MS, NR, Neg, Trace(5), Small(15), Moderate(40), Large(80), Large(160). UOB parameters were categorized as MS, NR, Neg, 1+, 2+, 3+, Non haemolysed trace, and haemolysed trace. PH results were categorized as MS. NR, normalresult, Neg, and range of pH (from 5-9in increments of 0.5). Data for indicated parameters was reported at Baseline (BL) and Week 7 (W7). The Baseline value was the measurement taken at Day 1.|Baseline and Week 7 of Part 2|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety Population||Participants|||Number
793659|NCT00908037|Secondary|Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1|Urinalysis parameters included: urine protein (UP), urine glucose (UG), urine ketones (UK), urine occult blood (UOB), and pH. The dipstick test gives results in a semi-quantitative manner. UP was categorized as missing (MS), no result (NR), negative (Neg), Trace, 1+, 2+, 3+ and 4+. UG results were categorized as MS, NR, Neg, normal, 5, 15(1+), 30(2+), 60(3+), 110(4+)UK parameters were categorized as as MS, NR, Neg, Trace(5), Small(15), Moderate(40), Large(80), Large(160). UOB parameters were categorized as MS, NR, Neg, 1+, 2+, 3+, Non haemolysed trace, and haemolysed trace. PH results were categorized as MS. NR, normalresult, Neg, and range of pH (from 5-9in increments of 0.5). Data for indicated parameters was reported at Baseline (BL) and Week 24 (W24). The Baseline value was the measurement taken at Day 1.|Baseline and Week 24 of Part 1|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety Population.||Participants|||Number
793660|NCT00908037|Secondary|Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3|Pulse rate was measured at the following scheduled time points: Screening, Day 1, each week from Week 1 to Week 24, and at each Follow-up Weeks 1-4. Baseline is defined as the value obtained on Day 1 of treatment. The maximum post-Baseline visit included any scheduled and unscheduled post-Baseline assessment. Participants randomized to receive eltrombopag for 7 weeks in Part 2 continued receiving eltrombopag for an additional 17 weeks in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 24. Participants randomized to receive placebo for 7 weeks in Part 2, received 24 weeks of eltrombopag in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 31.|From Week 1to Follow-up Week 4 of Part 2/3, up to Study Week 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety Population.||Beats per minute||Standard Deviation|Mean
793661|NCT00908037|Secondary|Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2|Pulse rate was measured at the following scheduled time points: Screening, Day 1, each week from Week 1 to Week 24, and at each Follow-up Weeks 1-4. Baseline is defined as the value obtained on Day 1 of treatment. The maximum post-Baseline visit included any scheduled and unscheduled post-Baseline assessment.|From Week 1 to Week 7 of Part 2|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Beats per minute||Standard Deviation|Mean
793662|NCT00908037|Secondary|Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1|Pulse rate was measured at the following scheduled time points: Screening, Day 1, each week from Week 1 to Week 24, and at each Follow-up Weeks 1-4. Baseline is defined as the value obtained on Day 1 of treatment. The maximum post-Baseline (MPB) visit included any scheduled and unscheduled post-Baseline assessment..|From Week 1 to Follow-up Week 4 of Part 1, up to Study Week 28|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population||Beats per minute||Standard Deviation|Mean
793663|NCT00908037|Secondary|Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3|Respiratory rate was measured at the following scheduled time points: Screening, Day 1, each week from Week 1 to Week 24, and at each Follow-up Weeks 1-4. Baseline is defined as the value obtained on Day 1 of treatment. The maximum post-Baseline visit included any scheduled and unscheduled post-Baseline assessment. Participants randomized to receive eltrombopag for 7 weeks in Part 2 continued receiving eltrombopag for an additional 17 weeks in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 24. Participants randomized to receive placebo for 7 weeks in Part 2, received 24 weeks of eltrombopag in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 31.|From Week 1 to Follow-up Week 4 of Part 2/3 up to Study Week 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.||Breaths per minute||Standard Deviation|Mean
793664|NCT00908037|Secondary|Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Randomized Period, Part 2|Respiratory rate was measured at the following scheduled time points: Screening, Day 1, each week from Week 1 to Week 24, and at each Follow-up Weeks 1-4. Baseline is defined as the value obtained on Day 1 of treatment. The maximum post-Baseline value included any scheduled and unscheduled post-Baseline assessment.|From Week 1 to Week 7 of Part 2|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety Population||Breaths per min||Standard Deviation|Mean
793665|NCT00908037|Secondary|Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1|Respiratory rate was measured at the following scheduled time points: Screening, Day 1, each week from Week 1 to Week 24, and at each Follow-up Weeks 1-4. Baseline is defined as the value obtained on Day 1 of treatment. The maximum post-Baseline value included any scheduled and unscheduled post-Baseline assessment.|From Baseline through Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population .||Breaths per min||Standard Deviation|Mean
793666|NCT00908037|Secondary|Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3|Vital sign assessments included systolic blood pressure (SBP) and diastolic blood pressure (DBP) measurements that were measured before any blood draw at the following scheduled time points: Screening, Day 1, each week from Week 1 to Week 24, at each Follow-up week (Week 1-4) and the maximum post- Baseline (BL) visit. BL is defined as the value obtained on Day 1of treatment. The maximum post-BL visit (MPB) included any scheduled and unscheduled post-BL assessment. Reference ranges (RR) for SBP (mmHg) (Lower limit of normal, normal, Upper limit of normal) for Cohort 1: <85, 85-115, >115; for Cohort 2: <85, 85-120,>120; and Cohort 3: <95, 95-135, >135. RR for DBP (mmHg) for Cohort 1: <45, 45-70,>70; for Cohort 2: <50, 50-75, >75; and Cohort 3: <55, 55-85, >85.|From Baseline through Study Week 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.||Participants|||Number
793667|NCT00908037|Secondary|Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2/3|Urine microscopy included Red Blood Cell (RBC) casts, white blood cell (WBC) casts, and epithelial renal tubular cell casts. Urine microscopy data was reviewed by the Medical Monitor in order to classify the results as positive or negative. The number of participants with positive finding at Baseline and at anytime post-Baseline (Post-BL) were reported. Baseline was defined as the value obtained at the first visit before treatment (Pre-trt). A positive result indicated if the result was positive for at least one of RBC casts, WBC casts, or epithelial renal tubular cell casts. Participants randomized to receive eltrombopag for 7 weeks in Part 2 continued receiving eltrombopag for an additional 17 weeks in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 24. Participants randomized to receive placebo for 7 weeks in Part 2, received 24 weeks of eltrombopag in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 31.|From Baseline and post-Baseline up to Study Week 31 of Part 2/3|Safety Population, only those participants enrolled during Part 2/3 were analyzed.||Participants|||Number
793668|NCT00908037|Secondary|Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2|Urine microscopy included Red Blood Cell (RBC) casts, white blood cell (WBC) casts, and epithelial renal tubular cell casts. Urine microscopy data was reviewed by the Medical Monitor in order to classify the results as positive or negative. The nmber of participants with positive finding at Baseline and at anytime post-Baseline (Post-BL) were reported. Baseline was defined as the value obtained at the first visit before treatment (Pre-trt). A positive result indicated if the result was positive for at least one of RBC casts, WBC casts, or epithelial renal tubular cell casts.|From Baseline and post-Baseline up to Study Week 7 of Part 2|Safety Population, only those participants enrolled during Part 2 were analyzed.||Participants|||Number
793669|NCT00908037|Secondary|Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 1|Urine microscopy included Red Blood Cell (RBC) casts, white blood cell (WBC) casts, and epithelial renal tubular cell casts. Urine microscopy data was reviewed by the Medical Monitor in order to classify the results as positive or negative. The number of participants with a positive result at any time post Baseline were reported. A positive result indicated if the result was positive for at least one of RBC casts, WBC casts, or epithelial renal tubular cell casts.|From Baseline up to Study Week 24 of Part 1|Safety Population, only those participants enrolled during Part 1 were analyzed.||Participants|||Number
793670|NCT00908037|Secondary|Number of Participants With the Indicated Renal Parameters Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3|Renal parameters included: creatinine (RR: 44.2 - 88.4 umol/L), creatinine clearance derived (RR: 89.0 - 165.0 milliliter per minute [ ml/min]), protein/creatinine (RR: 0.113- 18.0992 microgram per millimoles [mg/mmol]), and urea (RR: 1.785- 8.925 mmol/L). Baseline values were obtained at Day 1. The number of participants with the indicated renal parameters data outside the reference range (with high and low) any time post-Baseline are presented. Anytime post-Baseline assesments included any scheduled and unscheduled post-baseline assessment|Post-Baseline from Week 1 through Follow-up up to Study Week 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.||Participants|||Number
793671|NCT00908037|Secondary|Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3|Hematology parameters included: erythrocytes (RR: 4.2 - 6.1 teragrams per liter [TI/L]), hemoglobin (RR: 125 - 165 g/L), hematocrit (RR: 0.36 - 0.46), platelets (RR: 170 - 430 gigagrams per liter [GI/L]), mean platelet volume (MPV, RR: 4 - 14 femotoliter [fL]), leukocytes (RR: 3.4 - 11.2 GI/L), total neutrophils (RR: 2.1 - 4.9 GI/L), lymphocytes (RR: 1.4 - 2.9 GI/L), monocytes (RR: 0.2 - 0.9 GI/L), eosinophils (RR: 0.2 - 0.7 GI/L), and basophils (RR: 0.02 - 0.12 GI/L). Baseline values were obtained at Day 1. The number of participants with the indicated hematology parameters data outside of the reference range (with high and low) any time post-baseline are presented. Anytime post-Baseline assesments included any scheduled and unscheduled post-Baseline assessment|Post-Baseline from Week 1 through Follow-up up to Study Week 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.||Participants|||Number
793678|NCT00908037|Secondary|Number of Participants Who Required a Protocol-defined Rescue Treatment During Part 2/3|Rescue treatment was defined as either a new immune (idiopathic) thrombocytopenic purpura (ITP) medication, an increase in the dose of a concomitant ITP medication from Baseline, a platelet transfusion, or a splenectomy. For particpants randomized to placebo in Part 2, Baseline is defined as Week 7 of Part 2. For participants randomized to eltrombopag in Part 2, Baseline is defined as Day 1 of Part 2. Participants randmoized to receive eltrombopag for 7 weeks in Part 2 continued receiving eltrombopag for an additional 17 weeks in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 24. Participants randomized to receive placebo for 7 weeks in Part 2, received 24 weeks of eltrombopag in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 31.|From Baseline to the end of treatment up to Week 31 + 1 day of Part2/3|ITT Population, only those participants enrolled during Part 2/3 were analyzed.||Participants|||Number
793672|NCT00908037|Secondary|Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3|Clinical chemistry parameters included: aspartate amino transferase (AST, reference range [RR]: 0-38 International Units per Liter [IU/L]), alkaline phosphatase (ALP: RR: 50 - 375 IU/L), total bilirubin (RR: 3.42 - 22.23 micromoles [umol]/L), albumin grams [g/L], alanine amino transferase (ALT, RR: 5-30 IU/L), prothrombin international normalized ratio (PT INR, RR-0.9 - 1.2), activated partial thromboplastin time (APTT, RR: 24.2 - 32.9 seconds), glucose (RR: 4.107- 6.55018 millimoles [mmol]/L), potassium (3 - 5 mmol/L), and sodium (135 - 143 mmol/L). Baseline values were obtained at Day 1. The number of participants with the indicated clinical chemistry data outside of the reference range (with high and low) any time post-Baseline are presented. Anytime post-Baseline assesments included any scheduled and unscheduled post-Baseline assessment|Post-Baseline from Week 1 through Follow-up up to Study Week 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.||Participants|||Number
793673|NCT00908037|Secondary|Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3|The WHO Bleeding Scale is a measure of bleeding severity with the following grades: Grade 0 = no bleeding, Grade 1 = petechiae, Grade 2 = mild blood loss, Grade 3 = gross bleeding and Grade 4 = debilitating blood loss. The WHO grades were dichotomized into the following categories: no bleeding=Grade 0; any bleeding=Grades 1 to 4; no clinically significant bleeding=Grades 0 to 1; clinically significant bleeding=Grades 2 to 4. For participants randomized to Placebo in Part 2, Baseline defined as Week 7 of Part 2. For participants randomized to Eltrombopag in Part 2, Baseline defined as Day 1 of Part 2.|From Baseline of Part 2/3 through Follow-up|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Participants|||Number
793674|NCT00908037|Secondary|Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2|The WHO Bleeding Scale is a measure of bleeding severity with the following grades: Grade 0 = no bleeding, Grade 1 = petechiae, Grade 2 = mild blood loss, Grade 3 = gross bleeding and Grade 4 = debilitating blood loss. The WHO grades were dichotomized into the following categories: no bleeding=Grade 0; any bleeding=Grades 1 to 4; no clinically significant bleeding=Grades 0 to 1; clinically significant bleeding=Grades 2 to 4. For participants randomized to Placebo in Part 2, Baseline defined as Week 7 of Part 2. For participants randomized to Eltrombopag in Part 2, Baseline defined as Day 1 of Part 2.|From Baseline through Week 7 of Part 2|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Participants|||Number
793675|NCT00908037|Secondary|Kids’ ITP Tools (KIT) Questionnaire Total Score at Baseline, Week, 6, Week 12, and End of Treatment Visit as Assessed Using the KIT Questionnaire During the Eltrombopag Open-Label Period, Part 2/3|The KIT questionnaire measures the impact on the quality of life determined by the participant and the guardian by self reported outcomes at Baseline or the Screening Visit, after 6 weeks of treatment, after 12 weeks of treatment and at the end of treatment or withdrawal from the study. The KIT total score is calculated from the scores of each of the individual questions from Q1 – Q26 (excluding any answer that is ‘Not applicable’). The code list used for the individual question scores is: 1=never, 2=seldom, 3=sometimes, 4=often, 5=always and 9=not applicable. The range of values the total score can take is 0 (worst) to 100 (best). For subjects under the age of six, the family questionnaire (parental proxy) has been used.|From Baseline to end of treatment up to Study Week 31|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Score on scale||Standard Deviation|Mean
793676|NCT00908037|Secondary|Kids’ ITP Tool (KIT) Questionnaire Total Score at Baseline and Week 6as Assessed Using the KIT Questionnaire During the Randomized Period, Part 2|The KIT questionnaire measures the impact on the quality of life determined by the participant and the guardian by self reported outcomes at Baseline or the Screening Visit, after 6 weeks of treatment or withdrawal from the study. The KIT total score is calculated from the scores of each of the individual questions from Q1 – Q26 (excluding any answer that is ‘Not applicable’). The code list used for the individual question scores is: 1 = never, 2 = seldom, 3 = sometimes, 4 = often, 5 = always and 9 = not applicable. The range of values the total score can take is 0 (worst) to 100 (best). For subjects under the age of six, the family questionnaire (parental proxy) has been used.|Baseline and Week 6 of Part 2|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Score on scale||Standard Deviation|Mean
793677|NCT00908037|Secondary|Kids’ ITP Tool (KIT) Questionnaire Total Score at Baseline, Week 6, Week 12, and Week 24 as Assessed Using the KIT Questionnaire During the Dose Finding Period, Part 1|The KIT questionnaire measures the impact on the quality of life determined by the participant and the guardian by self reported outcomes at Baseline or the Screening Visit, after 6 weeks of treatment, after 12 weeks of treatment and at the end of treatment or withdrawal from the study. The KIT total score is calculated from the scores of each of the individual questions from Q1 – Q26 (excluding any answer that is ‘Not applicable’). The code list used for the individual question scores is: 1 = never, 2 = seldom, 3 = sometimes, 4 = often, 5 = always and 9 = not applicable. The range of values the total score can take is 0 (worst) to 100 (best). For subjects under the age of six, the family questionnaire (parental proxy) has been used.|Baseline, Week 6, Week 12, and Week 24 of Part 1|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Score on scale||Standard Deviation|Mean
793679|NCT00908037|Secondary|Percentage of Participants Who Reduced or Discontinued Baseline Concomitant ITP Medications During the 24 Weeks of Eltrombopag Treatment During Part 2/ 3|Participants who discontinued (dis) or had a sustained reduction (red) of a Baseline (BL) ITP medication for at least one day during the period of Day 1 of Part 2/3 to the last dose of study medication +1 day are reported. The denominator is the number of subjects taking an ITP medication at baseline. For participants randomized to placebo in Part 2, BL is defined as Week 7 of Part 2. For participants randomized to eltrombopag in Part 2, BL is defined as Day 1 of Part 2. A sustained reduction is defined as reduction for 4 weeks or more. An attempted reduction or discontinuation is a decrease in the dose or frequency from the BL dose or frequency of an ITP medication for at least one day during the period Part 2/3 Day 1 to the last dose of study medication + 1 day.|From Baseline to the end of treatment up to Week 31 + 1 day of Part 2/3|ITT Population, only those participants enrolled during Part 2/3 were analyzed.||Percentage of Participants|||Number
793680|NCT00908037|Secondary|Percentage of Participants Who Reduced or Discontinued Baseline Concomitant Idiopathic Thrombocytopenic Purpura (ITP) Medications During the 24 Weeks of Eltrombopag Treatment During Part 1.|The participants who discontinued (dis) or had a sustained reduction (red) of a Baseline (BL) ITP medication for at least one day during the period of Day 1 of Part 1 to the last dose of study medication +1 day are reported. The denominator is the number of subjects taking an ITP medication at baseline. For participants in Part 1, Baseline is defined as Day 1 of Part 1. A sustained reduction is defined as reduction for 4 weeks or more. An attempted red or dis is a decrease in the dose or frequency from the BL dose or frequency of an ITP medication for at least one day during the period Part 1 Day 1 to the last dose of study medication + 1 day.|From Baseline up to Week 24+ 1 day of Part 1|ITT Population, only those participants enrolled during Part 1 were analyzed.||Percentage of Participants|||Number
793681|NCT00908037|Secondary|Maximum Duration for Which a Participant Continuously Maintained a Platelet Count of >=50 Gi/L During the 24 Weeks of Eltrombopag Treatment in Part 2/ 3|The maximum duration for which a participant continuously maintained a platelet count >=50 Gi/L in the absence of rescue treatment was calculated and summarized during the 24 weeks of eltrombopag treatment in Part 2/3. Participants with non-weekly assessments were assumed to have maintained a positive response for each week between two assessments that had positive responses. If a particpant achieved a positive response at an assessment and then achieved a negative response at the next assessment, then it was assumed that the participant had achieved a positive response for one day. Participants randmoized to receive eltrombopag for 7 weeks in Part 2 continued receiving eltrombopag for an additional 17 weeks in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 24. Participants randomized to receive placebo for 7 weeks in Part 2, received 24 weeks of eltrombopag in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 31.|From Baseline up to Study Week 31|ITT Population only those participants enrolled in Part 2/3 were analyzed. The number of participants used to compute the summary statistics reflect the ITT poplation through out the analyses during Part 2/3.||Weeks||Full Range|Median
793682|NCT00908037|Secondary|Maximum Duration for Which a Participant Continuously Maintained a Platelet Count of >=50 Gi/L During the 7 Weeks of Eltrombopag Treatment in Part 2|The maximum duration for which a participant continuously maintained a platelet count >=50 Gi/L in the absence of rescue treatment was calculated and summarized during the 24 weeks of eltrombopag treatment in Part 2. Participants with non-weekly assessments were assumed to have maintained a positive response for each week between two assessments that had positive responses. If a particpant achieved a positive response at an assessment and then achieved a negative response at the next assessment, then it was assumed that the participant had achieved a positive response for one day. Excludes periods from initiation of rescue medication until platelet count falls to below 50Gi/L, irrespective of platelet count|From Baseline through Week 7 of Part 2|ITT Population, only those participants enrolled in Part 2 were analyzed. The number of participants used to compute the summary statistics reflect the ITT poplation through out the analyses during Part 2.||Weeks||Full Range|Median
793683|NCT00908037|Secondary|Population Pharmacokinetic (PK) Assessments for Eltrombopag for CL/F During Part 1, 2, and 2/3|The apparent plasma clearance following oral dosing of eltrombopag (CL/F) was collected to estimate primary model-based PK parameters. PK samples were collected within 3 hours prior to dosing and 2, 4, 6, 8 and 24 hours after dosing. PK samples were collected at each on-treatment visit during Part 1, Part 2, and Part 2/3. The concentration data were pooled across visits to identify population PK and variability parameter estimates and covariate effects. From the final model, a single value of CL/F was estimated for each subject, and geometric mean (95% CI) values are presented for each cohort for a 50mg dose.|From Day 1 of treatment up to Study Week 31|Pharmacokinetic (PK) population. All subjects who had received at least one dose of the investigational product and provided a PK sample were included in this analysis.||liter per hour (L/hr)||95% Confidence Interval|Geometric Mean
793684|NCT00908037|Secondary|Population Pharmacokinetic (PK) Assessments for Eltrombopag for Tmax During Part 1, 2, and 2/3|The time to maximum concentration (tmax) was collected to estimate primary model-based PK parameters. PK samples were collected within 3 hours prior to dosing and 2, 4, 6, 8 and 24 hours after dosing. PK samples were collected at each on-treatment visit during Part 1, Part 2, and Part 2/3. The concentration data were pooled across visits to identify population PK and variability parameter estimates and covariate effects. From the final model, a single value of tmax was estimated for each subject, and geometric mean (95% CI) values are presented for each cohort for a 50mg dose.|From Day 1 of treatment up to Study Week 31|Pharmacokinetic (PK) population. All subjects who had received at least one dose of the investigational product and provided a PK sample were included in this analysis.||hour (hr)||Full Range|Median
793685|NCT00908037|Secondary|Population Pharmacokinetic (PK) Assessments for Eltrombopag for Cmax and Ct During Part 1, 2, and 2/3.|The maximum observed concentration (Cmax) and the concentration at the end of the dosing interval (Ct) data were collected to estimate primary model-based PK parameters. PK samples were collected within 3 hours prior to dosing and 2, 4, 6, 8 and 24 hours after dosing. Doses were normalized to 50mg for comparison. PK samples were collected at each on-treatment visit during Part 1, Part 2, and Part 2/3. The concentration data were pooled across visits to identify population PK and variability parameter estimates and covariate effects. From the final model, a single value of Cmax and Ct were estimated for each subject, and geometric mean (95% CI) values are presented for each cohort for a 50mg dose.|From Day 1 of treatment up to Study Week 31|Pharmacokinetic (PK) population. All subjects who had received at least one dose of the investigational product and provided a PK sample were included in this analysis.||micrograms per milliliter (ug/mL)||95% Confidence Interval|Geometric Mean
793686|NCT00908037|Secondary|Population Pharmacokinetic (PK) Assessment for Eltrombopag for AUC(0-t) During Part 1, 2, and 2/3.|The area under the concentration-time curve over the dosing interval (AUC0-t) data was collected to estimate primary model-based PK parameters. PK samples were collected within 3 hours prior to dosing and 2, 4, 6, 8 and 24 hours after dosing. Doses were normalized to 50mg for comparison. PK samples were collected at each on-treatment visit during Part 1, Part 2, and Part 2/3. The concentration data were pooled across visits to identify population PK and variability parameter estimates and covariate effects. AUC(0-t) is defined as the area under the concentration-time curve over the dosing interval. From the final model, a single value of AUC(0-t) was estimated for each subject, and geometric mean (95% CI) values are presented for each cohort for a 50mg dose.|From Day 1 of treatment up to Study Week 31|Pharmacokinetic (PK) population. All subjects who had received at least one dose of the investigational product and provided a PK sample were included in this analysis.||Microgram*hour per milliliter (ug*h/mL)||95% Confidence Interval|Geometric Mean
793687|NCT00908037|Secondary|Percentage of Participants Achieving Platelet Counts >=50 Gi/L at Any Time During the 31 Weeks of Eltrombopag Treatment During Part 2/ 3.|The percentage of participants achieving platelet counts >=50Gi/L at least once at any time during the 24 weeks of eltrombopag treatment during Part 2/3 of the study were reported. Participants randmoized to receive eltrombopag for 7 weeks in Part 2 continued receiving eltrombopag for an additional 17 weeks in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 24. Participants randomized to receive placebo for 7 weeks in Part 2, received 24 weeks of eltrombopag in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 31.|Part 2/3 up to Study Week 31|ITT Population. Only evaluable participants were included for this analysis, where participants with a baseline platelet count >10 Gi/L was considered as evaluable.||Percentage of Participants|||Number
793688|NCT00908037|Secondary|Percentage of Participants Achieving Platelet Counts >=50Gi/L at Any Time During the 24 Weeks of Eltrombopag Dosing During Part 1.|The percentage of participants achieving platelet counts >=50Gi/L at least once at any time during the 24 weeks of eltrombopag treatment were reported.|From Day 1 of treatment up to Week 24 of Part 1|ITT Population only those participants enrolled during Part 1 were analyzed.||Percentage of Participants|||Number
793689|NCT00908037|Secondary|Weighted Mean Platelet Count|The weighted mean platelet count is defined as the area under the platelet-time curve divided by the duration of the treatment (12 weeks). Based on the Analysis of Covariance (ANCOVA) model, the weighted mean platelet count is the sum of the Baseline count plus the age cohort plus the treatment. Baseline was defined as the platelet count taken on Day 1 or within 48 hours prior to the first dose of treatment.|Baseline and Day 43 of Part 2|ITT Population. Only participants during Part 2 with a value at baseline and post-baseline were considered for analysis||Gi/L||Standard Deviation|Mean
793690|NCT00908037|Secondary|Percentage of Participants Achieving Platelet Counts >=50Gi/L During Treatment With Eltrombopag in >= 60% of Assessments Between Day 15 and Day 43 (Weeks 2 Through 6) of the Randomized Treatment Period (Part 2)|Sustained platelet response between the treatment groups was assessed by determining the number of participants who achieved a platelet count >=50 Gi/L during treatment with eltrombopag in >= 60% of assessments between Day 15 and Day 43 in the absence of rescue treatment were reported here.|Between Day 15 and Day 43 of Part 2|Intent-to-Treat (ITT) Population, only those participants enrolled in Part 2 of this study were analyzed.||Percentage of Participants|||Number
793691|NCT00908037|Primary|Percentage of Participants Achieving a Platelet Count >=50 Giga Cells Per Liter (Gi/L) at Least Once, Between Day 8 and Day 43 (Weeks 1 to 6) of the Randomized Period of the Study (Part 2)|Participants who achieved a platelet count >=50 Gi/L at least once between Day 8 and Day 43 (first 6 weeks of Part 2) in the absense of rescue treatment were reported. A 95% confidence interval was calculated by the exact binomial method.|From Day 8 up to Day 43 of Part 2|Intent-to-Treat (ITT) Population: all enrolled participants during Part 2. The ITT Population was the primary population used for assessing efficacy. Only evaluable participants were considered for analysis where participants with a Baseline platelet count >10Gi/L was considered as evaluable.||Percentage of Participants|||Number
793692|NCT00908076|Primary|Change From Baseline to End of Study|Global impression of change, stool diary, visual analog scale of improvement, UPDRS rating scale and constipation questionnaires. The primary efficacy data will be analyzed using Student’s t-test with unequal variances as the difference from baseline in SBM comparing cases and controls, using last observation carried forward for missing data in the intent-to-treat population.|Baseline to end of study|"A marked or very marked clinical global improvement.
Ondo WG et al. Placebo-controlled trial of lubiprostone for constipation associated with Parkinson disease. Neurology 2012 May 22; 78:1650. - See more at: http://www.jwatch.org/jn201205290000006/2012/05/29/lubiprostone-constipation-parkinson-disease#sthash.ggWrS7Vq.dpuf"||percentage of subjects improved|||Number
793693|NCT00908115|Primary|Number of Subjects Reporting Unsolicited Adverse Events|An adverse event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Within the 31-day (Day 0-30) following vaccination.|||Subjects|||Number
793694|NCT00908115|Primary|Number of Subjects Reporting Solicited Symptoms|"Solicited local symptoms assessed include induration, itching, pain, redness, and swelling.
Solicited general symptoms assessed include anorexia, convulsions, cough, diarrhea, drowsiness, eruption, fever, irritability, and vomiting."|During the 4-week follow-up period after each dose|Analysis was performed on the subjects who received the considered dose.||Subjects|||Number
793695|NCT00908115|Primary|Number of Subjects Reporting Serious Adverse Events|"A serious adverse event is any untoward medical occurrence that:
results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above."|Since the beginning of the study and during the entire study period (up to 6 years)|||Subjects|||Number
793696|NCT00908128|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of the Last Non-zero Concentration|Bioequivalence based on AUC0-t|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.||µg*hr/mL||Standard Deviation|Mean
793697|NCT00908128|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.||µg*hr/mL||Standard Deviation|Mean
793700|NCT00908232|Secondary|Overall Survival|Is defined as the time interval from start of treatment to the date of death due to any cause. In the absence of confirmation of death (including subjects lost to follow-up), survival time will be censored at the last date the subject is known to be alive|At each visit from baseline to end of treatment. After treatment, monthly visit until progression or relapse or until the start of alternative MMY therapy. Further follow up by monthly phone call until the last patient was treated and followed for 1 year|mITT: All patients with at least 1 dose and 1 post baseline assessment. The non-randomized CR/PR group, n=144 for Time to First confirmed Response. Low powered study because necessary sample size for the randomized part could not be reached. Thus, data were analyzed and reported by combining the randomized groups with SD, (n=19).||days||95% Confidence Interval|Median
793701|NCT00908232|Secondary|One Year Survival|Percent Probability of Survival at 1 year from the start of treatment, estimated using Kaplan-Meier analysis.|At each visit from baseline to end of treatment. After treatment, monthly visit until progression or relapse or until the start of alternative MMY therapy, up to 1 year|mITT: All patients with at least 1 dose and 1 post baseline assessment. The non- randomized CR/PR group, n=144 for Time to First confirmed Response. Low powered study because necessary sample size for the randomized part could not be reached. Thus, data were analyzed and reported by combining the randomized groups with SD, (n=19).||percent probability||95% Confidence Interval|Number
793702|NCT00908232|Secondary|Time to Progression|Is calculated as the time from start of treatment to the date of the first observation of disease progression or relapse from CR. Deaths owing to causes other than progression not counted, but censored. Subjects who withdraw from the study or die will be censored at the time of last disease assessment. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0).|At Day 1 of each treatment cycle, at the End of Treatment visit until there is evidence of Progressive Disease or relapse from Complete Response (CR), Median Follow-up of 16.9 months|mITT: All patients with at least 1 dose and 1 post baseline assessment. The non-randomized CR/PR group, n=144 for Time to First confirmed Response. Low powered study because necessary sample size for the randomized part could not be reached. Thus, data were analyzed and reported by combining the randomized groups with SD, (n=19).||days||95% Confidence Interval|Median
793703|NCT00908232|Secondary|Progression Free Survival|"Time from start of treatment to date of disease progression, relapse from CR or death. Estimated using the kaplan-meier method. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions, or similar definition as accurate and appropriate."|At Day 1 of each treatment cycle, at the End of Treatment visit until there is evidence of Progressive Disease or relapse from Complete Response (CR). Median Follow-Up of 16.9 months|mITT: All patients with at least 1 dose and 1 post baseline assessment. The non-randomized CR/PR group, n=144. Low powered study because necessary sample size for the randomized part could not be reached. Thus, data were analyzed and reported by combining the randomized groups with SD, (n=19).||days||95% Confidence Interval|Median
793704|NCT00908232|Secondary|Median Time to First Confirmed Response|Time from start of treatment to the date of the first documentation of a confirmed response. Estimated using the Kaplan-Meier method. Response was assessed using the International Myeloma Working Group (IMWG) Uniform Response Criteria and validated by an Independent Monitoring Committee.|At Day 1 of each treatment cycle, at the End of Treatment visit until there is evidence of Progressive Disease or relapse from Complete Response (CR), up to 168 days|mITT: All patients with at least 1 dose and 1 post baseline assessment. The non- randomized CR/PR group, n=144 for Time to First confirmed Response. Low powered study because necessary sample size for the randomized part could not be reached. Thus, data were analyzed and reported by combining the randomized groups with SD, (n=19).||days||95% Confidence Interval|Median
793705|NCT00908232|Primary|Overall Best Confirmed Response|Overall Best Confirmed Response is the best Overall Response Rate with borezomib-dexamathasone (+/-cyclophosphamide or lenalidomide) recorded between baseline and end of treatment. Response was assessed using the International Myeloma working Group (IMWG) Uniform Response Criteria and validated by an Independent Monitoring Committee.|Prior to treatment at day 1 of each cycle and at the end of treatment (day 21 of cycle 8), up to 168 days|mITT: All patients with at least 1 dose and 1 post baseline assessment. Low powered study because necessary sample size for the randomized part could not be reached. Thus, data were analyzed and reported by combining the randomized groups with SD, (n=19). Data are missing for 21 patients in the non-randomized CR/PR group, n=123.||number of participants|||Number
793706|NCT00908310|Primary|Capture of Post-marketing Safety Information in Patients With Moderate Renal Insufficiency Undergoing Routine Contrast-enhanced MRI With Administration of OMNISCAN in Order to Assess the Risk for Developing Nephrogenic Systemic Fibrosis (NSF).|Capture of safety information in moderate renal insufficiency patients undergoing routine contrast-enhanced MRI with administration of OMNISCAN.|Greater than or equal to 7 days post contrast administration.|Incidence of Nephrogenic Systemic Fibrosis (NSF)||percentage of subjects||95% Confidence Interval|Number
793707|NCT00908349|Primary|Percent Change in Seizure Rate|Measured as change from baseline to end of study|one year|||percentage of change in seizure rate||Full Range|Median
793708|NCT00908375|Secondary|Oswestry Disability Questionnaires|"Oswestry disability index (ODI) is a tool to measure a subject's functional disability. The Oswestry disability index consists of 10 questions with a Likert 0-5 scale. Each individual score is converted into a percent which represents the percent disability. There are five tiers, 0-20% (minimal disability), 21%-40% (moderate disability), 41%-60% (severe disability), 61%-80% (crippled), 81%-100% (i.e. bed bound). We report the Oswestry disability scores at 3 weeks."|3 weeks|||percent disability||Full Range|Median
793709|NCT00908375|Secondary|Patient's Global Impression of Change at 3 Weeks|"Global impression of change in patient status reported at 3 weeks. The global impression of change consists of a Likert scale as below:
Very Much Improved
Much Improved
Minimally Improved
No Change
Minimally Worse
Much Worse
Very Much Worse"|3 weeks|||units on a scale||Full Range|Median
793710|NCT00908375|Primary|Pain Scores (NRS) at 3-weeks|Standard numeric rating pain scale ranging from 0 (no pain) to 10 (worst pain imaginable) after 3 weeks of treatment.|3 weeks|||units on a scale||Full Range|Median
793719|NCT00908583|Secondary|Overall Safety of Bortezomib|Incidence of grade 3 and above non-hematologic toxicities. Incidence of grade 4 hematologic toxicities. Incidence of all grades of peripheral neuropathy. Incidence of Cytomegalovirus (CMV), Polyomavirus Allograft Nephropathy (PVN), and Posttransplant Lymphoproliferative Disorder (PTLD).|Study Day 62|||participants|||Number
793720|NCT00908596|Secondary|Number of Participants With “Excellent / Good / Adequate / Insufficient” Scores for Lesion Characterization|The investigator was to record the imaging efficacy by evaluation of lesion characterization using a 4 point scale (Excellent / Good / Adequate / Insufficient). For some participants the values were not collected.|Immediately after Primovist/Eovist-enhanced MRI|Full Analysis Set: all participants who were enrolled and received Primovist/Eovist||Participants|||Number
793721|NCT00908596|Secondary|Number of Participants With “Excellent / Good / Adequate / Insufficient” Scores for Lesion Delineation|The investigator was to record the imaging efficacy by evaluation of lesion delineation using a 4 point scale (Excellent / Good / Adequate / Insufficient). For some participants the values were not collected.|Immediately after Primovist/Eovist-enhanced MRI|Full Analysis Set: all participants who were enrolled and received Primovist/Eovist||Participants|||Number
793722|NCT00908596|Secondary|Number of Participants With “Excellent / Good / Adequate / Insufficient” Scores for Lesion Detection|The investigator was to record the imaging efficacy by evaluation of lesion detection using a 4 point scale (Excellent / Good / Adequate / Insufficient). For some participants the values were not collected.|Immediately after Primovist/Eovist-enhanced MRI|Full Analysis Set: all participants who were enrolled and received Primovist/Eovist||Participants|||Number
793723|NCT00908596|Secondary|Confidence of the Investigator to Make a Diagnosis Based on the Primovist/Eovist Enhanced MRI (Magnetic Resonance Imaging)|The investigator was to record his / her confidence in making a diagnosis using a 4 point scale (Very high confidence / High confidence / Moderate / Low confidence). For some participants the values were not collected.|Immediately after Primovist/Eovist-enhanced MRI|Full Analysis Set: all participants who were enrolled and received Primovist/Eovist||Participants|||Number
793724|NCT00908596|Secondary|Number of Participants With Moderate to Severe Renal Impairment in Whom no Biopsy Was Obtained Who Develop NSF-like Symptoms Based on Diagnostically Specific Clinical Information Summarized by Clinical Score|Participants in whom no biopsy was obtained with a clinical score of 4 on a scale comprising 0-other diagnosis, 1-inconsistent, 2-suggestive, 3-consistent, 4-highly consistent.|Up to 24 months following the administration of Primovist/Eovist|Full Analysis Set: all participants who were enrolled and received Primovist/Eovist||Participants|||Number
793725|NCT00908596|Primary|Number of Participants With Moderate to Severe Renal Impairment, Who Develop NSF (Nephrogenic Systemic Fibrosis), Based on Diagnostically Specific Clinical and Histopathological Information|A diagnosis of NSF was assumed for subjects with a minimum combined clinical (scale: 0-other diagnosis, 1-inconsistent, 2-suggestive, 3-consistent, 4-highly consistent) and histopathological score (same scale as clinical score). Either the clinical score or the histopathology score had to be at least 2, and the other at least 3.|Up to 24 months following the administration of Primovist/Eovist|Full Analysis Set: all participants who were enrolled and received Primovist/Eovist||Participants|||Number
793726|NCT00908648|Secondary|Detection of Flat and/or Depressed Adenomas|number of patients with at least 1 flat and/or depressed adenoma|duration of colonoscopy procedure|||participants|||Number
793727|NCT00908648|Primary|Adenoma Detection|Detection of adenoma, defined as the number of patients with > 1 adenoma, under White Light or NBI visualization|duration of colonoscopy procedure|||participants|||Number
793728|NCT00908687|Other Pre-specified|Cross-clade HI Antibody Titer Measurement: Compare the Heterologous HI Antibody Responses to the A/Indonesia/05/2005 (Clade 2.1) Strain of the H5N1 Virus.||6 months||||||
793729|NCT00908687|Other Pre-specified|Adjuvanticity Evaluation: Compare HI Immune Responses Achieved by Antigen and Adjuvant Combinations With Antigen Alone Groups.||6 months||||||
793730|NCT00908687|Secondary|Evaluate Treatment Group HI Responses Against US FDA Guidance for Industry: Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines (May 2007) and EMA CPMP/BWP/214/96 Criteria for Immunogenicity|"The percent of subjects achieving seroconversion for HI antibody titer should meet or exceed 40%
The percent of subjects achieving an HI antibody titer ≥ 1:40 should meet or exceed 70%
Geometric mean titer (GMT) fold increase > 2.5"|Day 28||||||
793731|NCT00908687|Secondary|Safety of a 100μg LT Patch||6 months||||||
793732|NCT00908687|Secondary|Safety of A/H5N1 Vaccine IM Injection With and Without an LT Adjuvant Patch||6 months||||||
793733|NCT00908687|Primary|Assess the Proportion of Subjects in Each Dose Group Achieving Seroconversion and Seroprotection for HI Antibody Titer Through Day 28.|Seroconversion is defined as either 1) baseline HI titer < 1:10 and a post-vaccination HI titer ≥ 1:40, or 2) baseline HI titer ≥ 1:10 and a minimum four-fold rise. Seroprotection is defined as a post-vaccination HI antibody titer ≥ 1:40.|Day 28|Primary Immunogenicity Evaluable Population (PIEP): all subjects who were consented, randomized, received the assigned treatment, had HI assay results at all the following time points: baseline (Day 0), Day 21 and Day 28, and did not have any major protocol deviations||percentage of subjects||95% Confidence Interval|Number
793734|NCT00908882|Secondary|Geriatric Depression Scale|range 1-15; >6 indicates depression|At the end of the 6-month follow-up period|These numbers represent those who completed the survey.||units on a scale||Standard Deviation|Mean
793735|NCT00908882|Secondary|Geriatric Depression Scale|range 1-15; >6 indicates depression|At the end of the 90-session intervention period|These numbers represent those that completed the survey.||units on a scale||Standard Deviation|Mean
793736|NCT00908882|Secondary|Post Traumatic Stress Disorder Checklist|range 17-85; >50 indicates PTSD diagnosis|At the end of the 6-month follow-up period|These numbers represent those that completed the survey.||units on a scale||Standard Deviation|Mean
793737|NCT00908882|Secondary|Post Traumatic Stress Disorder Checklist|range 17-85; >50 indicates PTSD diagnosis|At end of 90-session intervention period|These numbers represent those that completed the survey.||units on a scale||Standard Deviation|Mean
793756|NCT00909038|Secondary|Systolic Blood Pressure (SBP) After at Least 8 Weeks of Treatment in Overall Study Population|Mean SBP measured at the Study End|baseline to a minimum of 8 weeks of treatment|Descriptive statistical analysis was performed for the entire study population on the FAS in intention-to-treat (ITT) as well as on the Per protocol set (PPS) in per protocol (PP). The difference between the numbers of patients was inferior than 10% ; the results of the primary objective was presented in PPS.||mm Hg||Standard Deviation|Mean
793738|NCT00908882|Primary|Number of Participants Who Progressed Along the Stage of Change Toward Action as Measured by the Transtheoretical Model of Change (Short Form) Questionnaire. This Will Identify Current Stage of Change for Each Subject.|"Are you currently a smoker?
Yes, I currently smoke (move to For Smokers Only section)
No, I quit within the last 6 months (ACTION STAGE)
No, I quit more than 6 months ago (MAINTENANCE STAGE)
No, I have never smoked (NONSMOKER) (For smokers only) In the last year, how many times have you quit smoking for at least 24 hours?
(For smokers only) Are you seriously thinking of quitting smoking?
Yes, within the next 30 days (PREPARATION STAGE if they have one 24-hour quit attempt in the past year - refer to previous question... if no quit attempt then CONTEMPLATION STAGE)
Yes, within the next 6 months (CONTEMPLATION STAGE)
No, not thinking of quitting (PRECONTEMPLATION STAGE)"|During the 6-month follow-up period|||participants|||Number
793739|NCT00908882|Primary|Seven-day Point Prevalence -A Primary Outcome is the Number of Veteran's Who Self-reported Quit Smoking for Seven Days.||During the 6-month follow-up period|||participants|||Number
793740|NCT00908882|Primary|Self-reported Quit Attempts - The Primary Outcome is the Number of Veteran's Who Make a Self-reported Quit Attempt (as Defined as a 24-hour Point Prevalence Rate).||During the 6-month follow-up period|||participants|||Number
793741|NCT00908882|Primary|Seven-day Point Prevalence -A Primary Outcome is the Number of Veteran's Who Self-reported Quit Smoking for Seven Days.||During 90-session intervention period|||participants|||Number
793742|NCT00908882|Primary|Number of Participants Who Progressed Along the Stage of Change Toward Action as Measured by the Transtheoretical Model of Change (Short Form) Questionnaire. This Will Identify Current Stage of Change for Each Subject.|"Transtheoretical Model of Change questionnaire:
Are you currently a smoker?
Yes, I currently smoke (move to For Smokers Only section)
No, I quit within the last 6 months (ACTION STAGE)
No, I quit more than 6 months ago (MAINTENANCE STAGE)
No, I have never smoked (NONSMOKER) (For smokers only) In the last year, how many times have you quit smoking for at least 24 hours?
(For smokers only) Are you seriously thinking of quitting smoking?
Yes, within the next 30 days (PREPARATION STAGE if they have one 24-hour quit attempt in the past year - refer to previous question... if no quit attempt then CONTEMPLATION STAGE)
Yes, within the next 6 months (CONTEMPLATION STAGE)
No, not thinking of quitting (PRECONTEMPLATION STAGE)"|During 90-session intervention period|||participants|||Number
793743|NCT00908882|Primary|Self-reported Quit Attempts - The Primary Outcome is the Number of Veteran's Who Make a Self-reported Quit Attempt (as Defined as a 24-hour Point Prevalence Rate).||During 90-session intervention period|||participants|||Number
793744|NCT00908895|Secondary|Range of Movement of Wrist|"Range of motion were divided in subgroups: dorsal flexion, volar flexion, pronation, supination, radial inclination, cubital inclination.
Motion is described as a percentage of the opposite side."|6 months|||Percentage of opposite side||95% Confidence Interval|Mean
793745|NCT00908895|Primary|The Grip Strength|Grip strength measured with Jamar dynamometer in kilograms and adjusted to the opposite side in percentage. Correction made according to dominance.|6 months|No participant changed to the other group. Patients lost or with complications were not analyzed||Percentage of opposite side||95% Confidence Interval|Mean
793746|NCT00908908|Primary|Pharmacokinetics AUC (0-t) for Eribulin in Plasma|Area under the plasma concentration-time curve from time zero to last quantifiable plasma concentration measuring exposure to eribulin.|Between Days 1 and 8 of Cycle 1|Pharmacokinetic Population||ng eq*hr/mL/mg||Standard Deviation|Mean
793747|NCT00908908|Primary|Pharmacokinetics: AUC (0-t) for Total Radioactivity in Plasma|Area under the plasma concentration-time curve from time zero to last quantifiable plasma concentration measuring total radioactivity exposure.|Between Days 1 and 8 of Cycle 1|Pharmacokinetic Population||ng eq*hr/mL/mg||Standard Deviation|Mean
793748|NCT00908908|Primary|Excretion Balance of Radio-labeled 14C-eribulin: Total Recovery of Radioactive Dose in Urine and Feces.||312 hours postdose|Pharmacokinetic Population||percent recovery||Standard Deviation|Mean
793749|NCT00908960|Secondary|To Assess the Impact of Enoxaparin on Overall Survival.||years||||||
793750|NCT00908960|Secondary|To Investigate the Safety of Prophylactic Enoxaparin in Cancer Patients (Major Bleeding Episodes).||2 months||||||
793751|NCT00908960|Primary|The Cumulative Incidence of VTE at 2 Months.|The cumulative incidence of VTE at 2 months in the higher Venous thromboembolic events in cancer patients with high levels of circulating tissue factor bearing microparticles (TFMP).|2 months|All patients enrolled who underwent randomization and evaluation for baseline VTE.||Cumulative probability of having VTE||95% Confidence Interval|Number
793752|NCT00909038|Secondary|Rate of BP Control by Risk Factor According to the Recommendations ESH/ESC 2007|The proportion of patients with blood pressure (BP) control, per risk factor. High risk factors determined according to the recommendations of the ESH/ESC 2007.|Baseline to a minimum of 8 weeks of treatment|Per protocol set (PPS)||percentage of patients|||Number
793753|NCT00909038|Secondary|Diastolic Blood Pressure (DBP) After at Least 8 Weeks of Treatment in Population at High Cardiovascular Risk|Mean DBP measured at the Study End|baseline to a minimum of 8 weeks of treatment|Descriptive statistical analysis was performed for the entire study population on the FAS in intention-to-treat (ITT) as well as on the Per protocol set (PPS) in per protocol (PP). The difference between the numbers of patients was inferior than 10% ; the results of the primary objective was presented in PPS.||mmHg||Standard Deviation|Mean
793754|NCT00909038|Secondary|Systolic Blood Pressure (SBP) After at Least 8 Weeks of Treatment in Population at High Cardiovascular Risk|Mean SBP measured at the Study End|baseline to a minimum of 8 weeks of treatment|Descriptive statistical analysis was performed for the entire study population on the FAS in intention-to-treat (ITT) as well as on the Per protocol set (PPS) in per protocol (PP). The difference between the numbers of patients was inferior than 10% ; the results of the primary objective was presented in PPS.||mmHg||Standard Deviation|Mean
793755|NCT00909038|Secondary|Diastolic Blood Pressure (DBP) After at Least 8 Weeks of Treatment in Overall Study Population|Mean DBP measured at the Study End|baseline to a minimum of 8 weeks of treatment|Descriptive statistical analysis was performed for the entire study population on the FAS in intention-to-treat (ITT) as well as on the Per protocol set (PPS) in per protocol (PP). The difference between the numbers of patients was inferior than 10% ; the results of the primary objective was presented in PPS.||mm Hg||Standard Deviation|Mean
793839|NCT00909753|Primary|Cmax for Total Ursodiol - Baseline Corrected|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.||ng/mL||Standard Deviation|Mean
793757|NCT00909038|Primary|Rate of BP Control in Hypertensive Patients|"Percentage of controlled Patients at the Study End.
Control rate of hypertension in general practice and in cardiology defined as systolic blood pressure (SBP) and diastolic blood pressure (DBP) <140/90 mmHg for unselected hypertensive patients and SBP and DBP <130/80 mmHg for hypertensive patients at high cardiovascular risk (patients with diabetes and patients with impaired renal function) as defined in the recommendations of the French National Health Authority (HAS) 2005 guidelines."|Baseline to a minimum of 8 weeks of treatment|Descriptive statistical analysis was performed for the entire study population on the FAS in intention-to-treat (ITT) as well as on the Per protocol set (PPS) in per protocol (PP). The difference between the numbers of patients was inferior than 10% ; the results of the primary objective was presented in PPS.||Percentage of Participants||95% Confidence Interval|Number
793758|NCT00909064|Secondary|Incidence of Wound Infection|Incidence of Cellulitis in patients undergoing Arixtra treatment|Up to 10 days|||Participants|||Count of Participants
793759|NCT00909064|Secondary|Number of Days in Hospital.|Days after surgery to dischage|Up to 10 days|||days||Standard Deviation|Mean
793760|NCT00909064|Primary|Number of Days Until a Dry Wound|Days from day of surgery to stoppage of leakage from the wound|Up to 10 days|||days||Standard Deviation|Mean
793761|NCT00909155|Secondary|Vitals||each visit||||||
793762|NCT00909155|Primary|Functional Magnetic Resonance Imaging (fMRI) Response to an Emotional Regulation Task.||At study entry, 2 months and end of study (6 months)||||||
793763|NCT00909155|Primary|Hamilton Depression (HAM-D) and Anxiety (HAM-A) Rating Scales|"Hamilton Depression rating scale is a clinician assessment tool to measure severity of depression symptoms. Minimum score is 0 (no symptoms); maximum score is 52 (severe symptoms of depression).
Hamilton Anxiety rating scale is a clinician assessment tool to measure severity of anxiety symptoms. Minimum score is 0 (no symptoms); maximum score is 56 (severe symptoms of anxiety)."|Study entry, 2 months, and at end of study (6 mos)|||units on a scale||Standard Deviation|Mean
793764|NCT00909181|Primary|Change From Baseline in Mean Weekly Frequency of Urinary Incontinence Episodes at Week 12|Reduction in number of incontinent episodes, evaluated as mITT (modified intention to treat), after 12 weeks of treatment compared to baseline.|12 weeks|mITT (modified intended to treatment) per protocol Difference between Baseline and after 12 weeks treatment||Episodes||Standard Deviation|Mean
793765|NCT00909324|Secondary|Change in the Results of Schirmer’s Test From Baseline to End of Study|Schirmer's test determines tear production, and whether the eye produces enough tears to keep it moist. A small strip of filter paper is inserted inside the lower eyelid of each eye and the eyes are closed for 5 minutes. The paper is then removed and the length of paper that is moist is measured. A young person normally moistens 15 mm of the paper. The shorter the length of moist paper, the dryer the eyes. A positive change score indicates improvement.|Baseline (Pre-LASIK surgery), Day 1, Day 7 and Day 30 post-LASIK surgery|Intent-to-Treat population: All patients in the study who received study treatment.||mm||Standard Deviation|Mean
793766|NCT00909324|Secondary|Change in Tear Breakup Time From Baseline to End of Study|The time required for dry spots to appear on the corneal surface after blinking. Sodium fluorescein dye is added to the eye and the tear film is observed under a slit lamp while the patient avoids blinking until tiny dry spots develop. The longer it takes, the more stable the tear film. A short tear breakup time is a sign of a poor tear film. Generally, >10 seconds is thought to be normal, 5 to 10 seconds marginal, and <5 seconds low (with high likelihood of dry eye symptoms), ie, a shorter time indicates greater eye dryness. A positive change score indicates improvement.|Baseline (Pre-LASIK surgery), Day 1, Day 7 and Day 30 post-LASIK surgery|Intent-to-Treat population: All patients in the study who received study treatment.||Seconds||Standard Deviation|Mean
793767|NCT00909324|Primary|Change in Ocular Comfort Level From Baseline to End of Study|Patients rated their ocular comfort on a scale of 0 to 10 on the following parameters: Burning sensation, foreign body sensation, itching, watering of eyes, dryness of eyes, and photophobia. A higher score indicated greater discomfort. A negative change score indicated improvement.|Baseline (Pre-LASIK surgery), Day 1, Day 7 and Day 30 post-LASIK surgery|Intent-to-Treat population: All patients in the study who received study treatment.||Units on a scale||Standard Deviation|Mean
793768|NCT00909389|Primary|Number of Participants Who Had an Adverse Event (AE).|"The objective of this study was to evaluate the overall safety and tolerability of Vytorin (R) Tablet (Ezetimibe+Simvastatin) when used in patients with hypercholesterolemia.
All AEs observed by or volunteered to the investigator during this observational study, regardless of suspected causal relationship, were to have been considered an AE."|Throughout study up to Day 29 (Final Visit)|||participants|||Number
793769|NCT00909428|Primary|Change in Maximal Cystometric Capacity (mL)|At baseline, a small catheter is placed inside the participant's bladder. The bladder is filled with sterile water through the catheter and participants' maximal tolerated cystometric capacity (MCC) is measured in milliliters. Following completion of the bladder test, participants take 10mg solifenacin succinate (VesicareR) daily for 30 days. After 30 days of treatment, participants repeat the bladder test. Change in the MCC is used to evaluate the effectiveness of the drug.|30 Days|The primary outcome analysis population comprises only women with two valid MCC recordings (i.e., one baseline recording and one recording following 30 days of treatment with daily 10mg solifenacin succinate. The groups DOI and USI were combined for this repeated measures analysis.||milliliters (mL)||Inter-Quartile Range|Median
793770|NCT00909480|Secondary|"Number of Subjects Having the Adverse Event Incorrect Dose Administered"|"Number of subjects having the adverse event incorrect dose administered within the system organ class Injury, poisoning and procedural complications"|Weeks 0-26|Safety Analysis Set: All subjects that received at least one dose of the trial product.||Subjects|||Number
793771|NCT00909480|Secondary|Change in Body Weight From Baseline||Week 0, Week 26|Safety Analysis Set is all randomised subjects exposed to at least one dose of trial product.||kg||Standard Deviation|Mean
793772|NCT00909480|Secondary|Hypoglycemic Episodes, Unclassifiable|Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|Weeks 0-26|Safety Analysis Set is all randomised subjects exposed to at least one dose of trial product.||episodes|||Number
793840|NCT00909753|Primary|AUC0-72 for Unconjugated Ursodiol|Bioequivalence based on AUC0-72|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
793773|NCT00909480|Secondary|Hypoglycaemic Episodes, Nocturnal|Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|Weeks 0-26|Safety Analysis Set is all randomised subjects exposed to at least one dose of trial product.||episodes|||Number
793774|NCT00909480|Secondary|Hypoglycaemic Episodes, Diurnal|Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|Weeks 0-26|Safety Analysis Set is all randomised subjects exposed to at least one dose of trial product.||episodes|||Number
793775|NCT00909480|Secondary|Incidence of Hypoglycaemic Episodes During the Trial|Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|Weeks 0-26|Safety Analysis Set is all randomised subjects exposed to at least one dose of trial product.||episodes|||Number
793776|NCT00909480|Secondary|Glycaemic Control as Measured by Plasma Glucose (9-point Self-measured Profiles)|Plasma glucose measured: before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, bedtime and at 3 am.|Week 26|Full analysis set: All randomised subjects exposed to at least one dose of trial product categorised by randomised treatment.||mmol/L||Standard Deviation|Mean
793777|NCT00909480|Secondary|Within-subject Variation of Self Measured Plasma Glucose (SMPG) Before Breakfast|The median values of the sample standard variation (the within subject variation) within the IDet and IGlar arms were plotted against time.|Week 26|Full analysis set: All randomised subjects exposed to at least one dose of trial product categorised by randomised treatment.||mmol/L||Standard Deviation|Median
793778|NCT00909480|Secondary|Fasting Plasma Glucose (FPG)||Week 26|Full analysis set: All randomised subjects exposed to at least one dose of trial product categorised by randomised treatment.||mmol/L||Standard Deviation|Mean
793779|NCT00909480|Secondary|Percentage of Subjects Achieving HbA1c of 6.5% or Less With no Hypoglycaemia|The subjects must have reached target and not have experienced any confirmed symptomatic hypoglycaemia or any confirmed major hypoglycaemia within the last 30 days of treatment.|Week 26|Full analysis set: All randomised subjects exposed to at least one dose of trial product categorised by randomised treatment.||percentage (%) of subjects|||Number
793780|NCT00909480|Secondary|Percentage of Subjects Achieving HbA1c Less Than or Equal to 6.5%|The percentage of subjects – overall and by previous OAD treatment – meeting the HbA1c of 6.5% or less|Week 26|Full analysis set: All randomised subjects exposed to at least one dose of trial product categorised by randomised treatment.||percentage (%) of subjects|||Number
793781|NCT00909480|Secondary|Percentage of Subjects Achieving HbA1c of 7% or Less With no Hypoglycaemia|The subjects must have reached target and not have experienced any confirmed symptomatic hypoglycaemia or any confirmed major hypoglycaemia within the last 30 days of treatment.|Week 26|Full analysis set: All randomised subjects exposed to at least one dose of trial product categorised by randomised treatment.||percentage (%) of subjects|||Number
793782|NCT00909480|Secondary|Percentage of Subjects Achieving HbA1c Less Than or Equal to 7.0%|The percentage of subjects – overall and by previous OAD treatment – meeting the HbA1c less than or equal to 7%|Week 26|Full analysis set: All randomised subjects exposed to at least one dose of trial product categorised by randomised treatment.||percentage of subjects|||Number
793783|NCT00909480|Primary|Change in HbA1c From Baseline||Week 0, Week 26|Full analysis set: All randomised subjects exposed to at least one dose of trial product categorised by randomised treatment.||percentage point change||Standard Deviation|Mean
793784|NCT00909532|Secondary|Absolute Change From Baseline in Weight at Week 24 and Week 48|As malnutrition is common in patients with cystic fibrosis (CF) because of increased energy expenditures due to lung disease and fat malabsorption, body weight is an important clinical measure of nutritional status.|baseline to 24 weeks and 48 weeks|All randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo) and had available assessments during the time frame.||kilograms||Standard Error|Least Squares Mean
793785|NCT00909532|Secondary|Time-to-first Pulmonary Exacerbation Through Week 24 and Week 48|Pulmonary exacerbation was defined as a change in antibiotic therapy (intravenous, inhaled, or oral) for any 4 or more of signs/symptoms such as change in sputum; new or increased hemoptysis; increased cough or dyspnea; malaise, fatigue, or lethargy; temperature above 38 degrees C; anorexia or weight loss; sinus pain/tenderness and discharge; change in physical examination of the chest; decreased pulmonary function by 10%; and radiographic changes indicative of pulmonary infection.|baseline through 24 weeks and 48 weeks|All randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo) and had available assessments during the time frame.||proportion of event-free participants||95% Confidence Interval|Number
793786|NCT00909532|Secondary|Absolute Change From Baseline in Sweat Chloride Concentration Through Week 24 and Week 48|The sweat chloride (quantitative pilocarpine iontophoresis) test is a standard diagnostic tool for cystic fibrosis (CF), serving as an indicator of cystic fibrosis transmembrane conductance regulator (CFTR) activity.|baseline through 24 weeks and 48 weeks|All randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo) and had available assessments during the time frame..||millimoles per liter||Standard Error|Least Squares Mean
793787|NCT00909532|Secondary|Absolute Change From Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Score Through Week 24 and Week 48 (Respiratory Domain Score, Pooled)|The CFQ-R is a health-related quality of life measure for subjects with cystic fibrosis. Each domain is scored from 0 (worst) to 100 (best). A difference of at least 4 points in the respiratory domain score of the CFQ-R is considered a minimal clinically important difference (MCID).|baseline through 24 weeks and 48 weeks|All randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo) and had available assessments during the time frame.||score on a scale||Standard Error|Least Squares Mean
793841|NCT00909753|Primary|Cmax for Unconjugated Ursodiol|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.||ng/mL||Standard Deviation|Mean
793788|NCT00909532|Secondary|Absolute Mean Change From Baseline in Percent Predicted FEV1 Through Week 48|Spirometry (as measured by FEV1) is a standardized assessment to evaluate lung function that is the most widely used endpoint in cystic fibrosis studies.|baseline through 48 weeks|All randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo) and had available assessments during the time frame..||percent of predicted volume (L)||Standard Error|Least Squares Mean
793789|NCT00909532|Primary|Absolute Mean Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through Week 24|Spirometry (as measured by FEV1) is a standardized assessment to evaluate lung function that is the most widely used endpoint in cystic fibrosis studies.|baseline through 24 weeks|All randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo) and had available assessments during the time frame.||percent of predicted volume (L)||Standard Error|Least Squares Mean
793790|NCT00909545|Secondary|Common Adverse Events: Hypotension|Vascular Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.|Baseline to 12 months or the time to require dopaminergic therapy|||participants|||Number
793791|NCT00909545|Secondary|Common Adverse Events: Back Pain|Musculoskeletal and Connective Tissue Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.|Baseline to 12 months or the time to require dopaminergic therapy|||participants|||Number
793792|NCT00909545|Secondary|Common Adverse Events: Sinusitis|Infections and Infestations. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.|Baseline to 12 months or the time to require dopaminergic therapy|||participants|||Number
793793|NCT00909545|Secondary|Common Adverse Events: Diarrhoea|Gastrointestinal Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.|Baseline to 12 months or the time to require dopaminergic therapy|||participants|||Number
793794|NCT00909545|Secondary|Common Adverse Events: Dyspepsia|Gastrointestinal Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.|Baseline to 12 months or the time to require dopaminergic therapy|||participants|||Number
793795|NCT00909545|Secondary|Common Adverse Events: Insomnia|Psychiatric Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.|Baseline to 12 months or the time to require dopaminergic therapy|||participants|||Number
793796|NCT00909545|Secondary|Common Adverse Events: Somnolence|Nervous System Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.|Baseline to 12 months or the time to require dopaminergic therapy|||participants|||Number
793797|NCT00909545|Secondary|Common Adverse Events: Depression|Psychiatric Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.|Baseline to 12 months or the time to require dopaminergic therapy|||participants|||Number
793798|NCT00909545|Secondary|Common Adverse Events: Upper Respiratory Tract Infection|Infections and Infestations. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.|Baseline to 12 months or the time to require dopaminergic therapy|||participants|||Number
793799|NCT00909545|Secondary|Common Adverse Events: Nausea|Gastrointestinal Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.|Baseline to 12 months or the time to require dopaminergic therapy|||participants|||Number
793800|NCT00909545|Secondary|Common Adverse Events: Fatigue|General Disorders and Administration Site Conditions. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.|Baseline to 12 months or the time to require dopaminergic therapy|||participants|||Number
793801|NCT00909545|Secondary|Common Adverse Events: Constipation|Gastrointestinal Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.|Baseline to 12 months or the time to require dopaminergic therapy|||participants|||Number
793802|NCT00909545|Secondary|Common Adverse Events: Headache|Nervous System disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.|Baseline to 12 months or the time to require dopaminergic therapy|||participants|||Number
793803|NCT00909545|Secondary|Common Adverse Events: Nasopharyngitis|Infections and infestations. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.|Baseline to 12 months or the time to require dopaminergic therapy|||participants|||Number
793804|NCT00909545|Secondary|Common Adverse Events: Dizziness|Nervous system disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.|Baseline to 12 months or the time to require dopaminergic therapy|||participants|||Number
793805|NCT00909545|Secondary|Common Adverse Events: Oedema Peripheral|General disorders and administration site conditions. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects.|Baseline to 12 months or the time to require dopaminergic therapy|||participants|||Number
793806|NCT00909545|Secondary|Vital Signs: Change in Pulse Supine||Baseline to 12 months or the time to require dopaminergic therapy|||beats per minute||Standard Error|Least Squares Mean
793807|NCT00909545|Secondary|Vital Signs: Change in Pulse Standing||Baseline to 12 months or the time to require dopaminergic therapy|||beats per minute||Standard Error|Least Squares Mean
793808|NCT00909545|Secondary|Vital Signs: Change in Diastolic Supine||Baseline to 12 months or the time to require dopaminergic therapy|||mm Hg||Standard Error|Least Squares Mean
793809|NCT00909545|Secondary|Vital Signs: Change in Diastolic Standing||Baseline to 12 months or the time to require dopaminergic therapy|||mm Hg||Standard Error|Least Squares Mean
793810|NCT00909545|Secondary|Vital Signs: Change in Systolic Supine||Baseline to 12 months or the time to require dopaminergic therapy|||mm Hg||Standard Error|Least Squares Mean
793811|NCT00909545|Secondary|Vital Signs: Change in Systolic Standing||Baseline to 12 months or the time to require dopaminergic therapy|||mm Hg||Standard Error|Least Squares Mean
793812|NCT00909545|Secondary|Efficacy: Change in Parkinson Disease Quality of Life Questionnaire-39(PDQ-39)|The PD Quality of Life Scale(PDQ-39) asks the subject to evaluate how Parkinson disease has affected their health and overall quality of life at that point in time. The total quality of life scale includes subscales relating to social role, self-image/sexuality, sleep, outlook, physical function and urinary function. The outcome is defined as change in PDQ-39 between the baseline visit and month 12 or the time of sufficient disability to require dopaminergic therapy. It is scored on a scale of zero to 100, with lower scores indicating better health and higher scores more severe disability.|Baseline to 12 months or the time to require dopaminergic therapy|All participants were included in primary and secondary outcome analyses||units on a scale||Standard Error|Least Squares Mean
793813|NCT00909545|Secondary|Efficacy: Change in Montreal Cognitive Assessment|The Montreal Cognitive Assessment(MoCA) is a brief 30-point screening instrument that was developed and validated to identify subjects with mild cognitive impairment. The outcome is defined as change in MoCA between the baseline visit and month 12 or the time of sufficient disability to require dopaminergic therapy. Total MoCA score represents the sum of these 30-points, with a lower score indicating greater cognitive impairment. 30 is the maximum score, with a score of 26 or higher considered normal and below 26 indicative of Mild Cognitive Impairment.|Baseline to 12 months or the time to require dopaminergic therapy|All participants were included in primary and secondary outcome analyses||units on a scale||Standard Error|Least Squares Mean
793814|NCT00909545|Secondary|Efficacy: Change in Beck Depression Inventory II (BDI-II)|The Beck Depression Inventory (BDI) is a validated self-reported 21-item depression scale that was tested and validated as a reliable instrument for screening for depression in PD. The outcome is defined as change in BDI-II between the baseline visit and month 12 or the time of sufficient disability to require dopaminergic therapy. Total BDI score represents the sum of these 21-items. A higher change in score indicates a greater increase in disability. Total score of 0-13 is considered minimal, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.|Baseline to 12 months or the time to require dopaminergic therapy|All participants were included in primary and secondary outcome analyses||units on a scale||Standard Error|Least Squares Mean
793815|NCT00909545|Secondary|Efficacy: Change in Modified Schwab & England Independence Scale|The Schwab & England scale is an investigator and subject assessment of the subject's level of independence at all scheduled study visits. The subject will be scored on a percentage scale reflective of his/her ability to perform acts of daily living in relation to what he/she did before Parkinson's disease appeared. The outcome is defined as change in Schwab & England Independence Scale between the baseline visit and month 12 or the time of sufficient disability to require dopaminergic therapy. Higher decrease in score indicates higher disability. Score ranges from 100% (complete independence) to 0% (total disability).|Baseline to 12 months or the time to require dopaminergic therapy|All participants were included in primary and secondary outcome analyses||units on a scale||Standard Error|Least Squares Mean
793816|NCT00909545|Secondary|Efficacy: Change in Modified Hoehn & Yahr Scale|The Modified Hoehn & Yahr Scale is an 8-level Parkinson's disease staging instrument. The outcome is defined as change in Modified Hoehn & Yahr Scale between the baseline visit and month 12 or the time of sufficient disability to require dopaminergic therapy. A greater increase in stage indicates a greater increase in disability. Stage ranges from 0-5 (also including 1.5 and 2.5) with 0 indicating no disability and 5 indicating maximum disability.|Baseline to 12 months or the time to require dopaminergic therapy|All participants were included in primary and secondary outcome analyses||units on a scale||Standard Error|Least Squares Mean
793817|NCT00909545|Secondary|Efficacy: Change in Motor Subscale of the Unified Parkinson's Disease Rating Scale|The outcome is defined as change in Motor subscale of the Unified Parkinson's Disease Rating Scale(UPDRS Part III) between the baseline visit and month 12 or the time of sufficient disability to require dopaminergic therapy. UPDRS Part III: motor abilities at the time of the visit, consisting of 27 items (including 13 general questions and 14 sub-questions) each answered on a 0-4 point scale where 0 represents the absence of impairment and 4 represents the highest degree of impairment. Total Part III score represents the sum of these 27 items. A total of 108 points are possible. 108 represents the worst (total) disability), 0--no disability.|Baseline to 12 months or the time to require dopaminergic therapy|All participants were included in primary and secondary outcome analyses||units on a scale||Standard Error|Least Squares Mean
793818|NCT00909545|Secondary|Efficacy: Change in Activities of Daily Living(ADL) Subscale of the Unified Parkinson's Disease Rating Scale|The outcome is defined as change in ADL subscale of the Unified Parkinson's Disease Rating Scale(UPDRS Part II) between the baseline visit and month 12 or the time of sufficient disability to require dopaminergic therapy. UPDRS Part II: Activities of Daily Living in the week prior to the designated visit, consisting of 13 questions answered on a 0-4 point scale where 0 represents the absence of impairment and 4 represents the highest degree of impairment. Total Part II score represents the sum of these 13 questions. A greater increase in score indicates a greater increase in disability. A total of 52 points are possible. 52 represents the worst (total) disability), 0--no disability|Baseline to 12 months or the time to require dopaminergic therapy|All participants were included in the primary and secondary outcome analyses||units on a scale||Standard Error|Least Squares Mean
793819|NCT00909545|Secondary|Efficacy: Change in Mental Subscales of the Unified Parkinson's Disease Rating Scale|The outcome is defined as change in Mental subscale of Unified Parkinson's Disease Rating Scale(UPDRS Part I) between the baseline visit and month 12 or the time of sufficient disability to require dopaminergic therapy. UPDRS Part I: Mentation, behavior and mood, consisting of 4 questions answered on a 0-4 point scale where 0 represents the absence of impairment and 4 represents the highest degree of impairment. Total score represents the sum of these 4 questions. A greater increase in score indicates a greater increase in disability. A total of 16 points are possible. 16 represents the worst (total) disability), 0--no disability.|Baseline to 12 months or the time to require dopaminergic therapy|All participants were used in primary and secondary outcome analyses||units on a scale||Standard Error|Least Squares Mean
793820|NCT00909545|Primary|Tolerability of the Three Dosages(5mg, 10mg and 20mg) of Isradipine CR.|Tolerability will be judged by the proportion of subjects enrolled in a dosage group able to complete the 12 month study or to the time of initiation of dopaminergic therapy on their original assigned dosage. Tolerability of each active arm will be compared to placebo group.|Baseline to 12 months or the time to require dopaminergic therapy|||participants|||Number
793821|NCT00909545|Secondary|Efficacy: Change in Unified Parkinson's Disease Rating Scale (UPDRS)|Outcome is defined as change in total Unified Parkinson's Disease Rating Scale (UPDRS) between the baseline visit and month 12 or the time to require dopaminergic therapy (last visit before subject goes on dopaminergic therapy), whichever occurs first. The UPDRS score has 4 components. Part I assesses mentation; Part II assesses activities of daily living; Part III assesses motor abilities; Part IV assesses complications of therapy. A total of 44 items are included in Parts I-III. Each item will receive a score ranging from 0 to 4 where 0 represents the absence of impairment and 4 represents the highest degree of impairment. Part IV contains 11 items, 4 of these items are scored 0-4 in the same manner, and 7 are scored 0-1, with 0 indicating the absence of impairment and 1 indicating the presence of impairment. Total UPDRS score represents the sum of these items in Parts I-IV. A total of 199 points are possible. 199 represents the worst (total) disability), 0--no disability.|Baseline to 12 months or the time to require dopaminergic therapy|Participants are 99 subjects with early Parkinson disease not requiring dopaminergic therapy.||Scores on a scale||Standard Error|Least Squares Mean
793822|NCT00909610|Primary|AUC0-72 for Unconjugated Ursodiol - Baseline Corrected|Bioequivalence based on AUC0-72|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
793823|NCT00909610|Primary|Cmax for Unconjugated Ursodiol - Baseline Corrected|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.||ng/mL||Standard Deviation|Mean
793824|NCT00909610|Primary|AUC0-72 for Unconjugated Ursodiol|Bioequivalence based on AUC0-72|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
793825|NCT00909610|Primary|Cmax for Unconjugated Ursodiol|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.||ng/mL||Standard Deviation|Mean
793826|NCT00909610|Primary|AUC0-72 for Baseline Corrected Total Ursodiol|Bioequivalence based on AUC0-72|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
793827|NCT00909610|Primary|Cmax for Baseline Corrected Total Ursodiol|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.||ng/mL||Standard Deviation|Mean
793828|NCT00909610|Primary|AUC0-72 - Area Under the Concentration-time Curve From Time Zero to 72 Hours - for Total Ursodiol|Bioequivalence based on AUC0-72|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
793829|NCT00909610|Primary|Cmax - Maximum Observed Concentration - for Total Ursodiol|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.||ng/mL||Standard Deviation|Mean
793830|NCT00909649|Primary|Seroma Formation|the mean total drainage volume|within 30 days postoperative|ITT||ml||Standard Deviation|Mean
793831|NCT00909727|Secondary|Absolute Change From Baseline in Weight at Week 24 and Week 48|As malnutrition is common in patients with cystic fibrosis (CF) because of increased energy expenditures due to lung disease and fat malabsorption, body weight is an important clinical measure of nutritional status.|baseline to 24 weeks and 48 weeks|All randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo) and had available assessments during the time frame.||kilograms||Standard Error|Least Squares Mean
793832|NCT00909727|Secondary|Absolute Change From Baseline in Sweat Chloride Concentration Through Week 24 and Week 48|The sweat chloride (quantitative pilocarpine iontophoresis) test is a standard diagnostic tool for cystic fibrosis (CF), serving as an indicator of cystic fibrosis transmembrane conductance regulator (CFTR) activity.|baseline through 24 weeks and 48 weeks|All randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo) and had available assessments during the time frame.||millimoles per liter||Standard Error|Least Squares Mean
793833|NCT00909727|Secondary|Absolute Change From Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Through Week 24 and Week 48 (Respiratory Domain Score, Children)|The CFQ-R is a health-related quality of life measure for subjects with cystic fibrosis. Each domain is scored from 0 (worst) to 100 (best). A difference of at least 4 points in the respiratory domain score of the CFQ-R is considered a minimal clinically important difference (MCID).|baseline through 24 weeks and 48 weeks|All randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo) and had available assessments during the time frame.||score on a scale||Standard Error|Least Squares Mean
793834|NCT00909727|Secondary|Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through Week 48|Spirometry (as measured by FEV1) is a standardized assessment to evaluate lung function that is the most widely used endpoint in cystic fibrosis studies.|baseline through 48 weeks|All randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo) and had available assessments during the time frame.||percent of predicted volume (L)||Standard Error|Least Squares Mean
793835|NCT00909727|Primary|Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through Week 24|Spirometry (as measured by FEV1) is a standardized assessment to evaluate lung function that is the most widely used endpoint in cystic fibrosis studies.|baseline through 24 weeks|All randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo)and had available assessments during the time frame.||percent of predicted volume (L)||Standard Error|Least Squares Mean
793836|NCT00909753|Primary|AUC0-72 for Unconjugated Ursodiol - Baseline Corrected|Bioequivalence based on AUC0-72|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
793837|NCT00909753|Primary|Cmax for Unconjugated Ursodiol - Baseline Corrected|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.||ng/mL||Standard Deviation|Mean
793838|NCT00909753|Primary|AUC0-72 for Total Ursodiol - Baseline Corrected|Bioequivalence based on AUC0-72|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
793844|NCT00909779|Secondary|Inspiratory Capacity (IC): Mean Change From Baseline|"IC: the total amount of air that can be drawn into the lungs after normal expiration.
IC was measured pre- and post-albuterol administration at Visit 1 (screening), pre-dose at baseline, months 3, 6, 9 and 12/EOS. IC maneuvers were done in triplicate. The mean of all recorded IC values was used for each subject at each time point. Study baseline was defined as the Visit 2 pre-dose value. If the Visit 2 pre-dose value was missing, the last IC value obtained prior to first treatment dose was used for baseline."|Baseline and on treatment at months 3, 6, 9 and 12 (or early termination)|Intent-to-treat population: subjects who were randomized to treatment and received at least 1 dose of study medication.||Liter||Standard Error|Least Squares Mean
793845|NCT00909779|Secondary|Forced Vital Capacity (FVC): Mean Change From Baseline|Forced Vital capacity: the volume of air that can forcibly be blown out after full inspiration. Best FVC was measured at Visit 1 (screening), pre-dose at baseline, months 3, 6, 9 and 12/EOS. The best FVC from at least 3 acceptable maneuvers was recorded.|Baseline and on treatment at months 3, 6, 9 and 12 (or early termination)|Intent-to-treat population: subjects who were randomized to treatment and received at least 1 dose of study medication.||Liter||Standard Error|Least Squares Mean
793846|NCT00909779|Secondary|Percent Predicted FEV1: Mean Change From Baseline|"Percent predicted FEV1: measured FEV1 as a percent of the predicted values for the patients of similar characteristics (height, age, sex, and sometimes race and weight). Best FEV1 percent predicted was measured at Visit 1 (screening), pre-dose at baseline, months 3, 6, 9 and 12/EOS, as described for FEV1."|Baseline and on treatments at months 3, 6, 9 and 12 (or early termination)|Intent-to-treat population: subjects who were randomized to treatment and received at least 1 dose of study medication.||Liter||Standard Error|Least Squares Mean
793847|NCT00909779|Secondary|FEV1: Mean Change From Baseline|FEV1 was measured at Visit 1 (screening), pre- and post-albuterol administration for reversibility testing, pre-dose at baseline, months 3, 6, 9 and 12/EOS. The best FEV1 from at least 3 acceptable maneuvers was recorded. Study baseline was defined as the Visit 2 pre-dose value. If the Visit 2 pre-dose value was missing, the last FEV1 value obtained prior to first treatment was used for baseline.|Baseline and on treatments at months 3, 6, 9 and 12 (or early termination)|Intent-to-treat population: subjects who were randomized to treatment and received at least 1 dose of study medication.||Liter||Standard Error|Mean
793848|NCT00909779|Secondary|SGRQ: Mean Change From Baseline in Total Score|The SGRQ assessed health status and consisted of 3 component scores (Symptoms, Activity, and Impacts) as well as a total score. Items were scored in accordance with the developer’s guidelines. Scores were expressed as a percentage of overall impairment, where 100 represented worst possible health status and 0 indicated best possible health status. The SGRQ was assessed pre-dose at baseline, months 3, 6 and 12 or the end of study (EOS). Visit 2 was defined as baseline. A change from baseline in the Total Score of ≥ 4 units is considered the minimal clinically important difference (MCID) for SGRQ.|Baseline and on treatment at months 3, 6 and 12 (or early termination)|Intent-to-treat population: subjects who were randomized to treatment and received at least 1 dose of study medication.||Score||Standard Error|Least Squares Mean
793849|NCT00909779|Secondary|The Incidence of Treatment Emergent AEs|"TEAEs were defined as: 1) adverse events that occurred on or after the date of first dose of study medication, 2) adverse events with a missing start date and a stop date on or after the date of first does of study medication, or 3) adverse events with both a missing start and stop date.
The frequency and percentage of subjects with TEAEs were summarized. At each level of summarization, a subject was counted only once for each AE he/she experienced within that level. The percentage of subjects having had at least 1 AE at each level was calculated."|0-12 months|Intent-to-treat population: subjects who were randomized to treatment and received at least 1 dose of study medication.||participants|||Number
793850|NCT00909779|Secondary|The Incidence of All Cause Mortality|Survival status at the end of the study will be determined for each subject. The proportion of subjects dead and the annual event rate will be summarized by treatment.|0-12 months|Intent-to-treat population: subjects who were randomized to treatment and received at least 1 dose of study medication.||participants|||Number
793851|NCT00909779|Secondary|The Incidence of Protocol Defined COPD Exacerbations.|A protocol-defined exacerbation of COPD was defined as an increase in respiratory symptoms (classically, increased shortness of breath, increased sputum production, and/or increased sputum purulence) that necessitates any change in baseline medication other than bronchodilators (e.g., anti-inflammatory agents, antibiotics, supplemental oxygen therapy, etc) or causes the subject to require additional medical attention (i.e., emergency room visit or hospitalization).|0-12 months|Intent-to-treat population: subjects who were randomized to treatment and received at least 1 dose of study medication.||participants|||Number
793852|NCT00909779|Primary|Time From Randomization to Respiratory Death or First COPD Exacerbation Related Hospitalization (Whichever Occurs First).|COPD exacerbation: an increase in COPD symptoms that necessitated any change in baseline medication (bronchodilators,anti-inflammatory agents, antibiotics, supplemental oxygen therapy, etc.).Hospitalization: any inpatient admission or any emergency department visit > 24 hours in duration. Hospice was considered hospitalization.COPD exacerbation related hospitalization: hospitalization that was due to 1) COPD exacerbation or 2) a COPD exacerbation preceded, or occurred concomitantly with the onset of, the event for which the subject was hospitalized.Respiratory-related death: For each death the Primary Investigator designated a ‘probable cause’, which was the primary condition that precipitated the terminal events that were the immediate cause of death. If a probable cause could not be ascertained, the cause of death was considered ‘UNKNOWN’. Cause other than ‘UNKNOWN’ was categorized as either respiratory or non-respiratory. Deaths of ‘UNKNOWN’ cause were counted as primary events.|0-12 months|Intent-to-treat population: subjects who were randomized to treatment and received at least 1 dose of study medication.||Days|Participants|Standard Deviation|Mean
793853|NCT00909792|Primary|Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity|Tested while reading charts distant to the subject with both eyes together in normal lighting. This outcome is measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 equates to 20/20 Snellen acuity and is considered normal. Positive logMAR values indicate poorer vision and negative values denote better visual acuity.|After 1 week of wear|Per Protocol. Analysis excluded major protocol deviations as determined by masked review.||logMAR||Standard Deviation|Mean
793854|NCT00909844|Post-Hoc|Percentage of Children With a Stabilisation or Regression of Tanner Pubic Hair Pubertal Stage at the End of the Study (Last Visit on Treatment), Compared to Pretreatment (Month -6)|One secondary efficacy endpoint in this study was the percentage of children who had stabilisation or regression (no change in grade or a reduced grade) of Tanner pubic hair pubertal stage at the end of the study. Results reported for this secondary endpoint applied the variable ‘Final Visit’ for comparison to Pretreatment and Baseline. Since it was determined that the majority of patients had a Final Visit >3 months after their last injection, a post-hoc analysis of the percentage of children with regression or stabilisation of Tanner pubic hair pubertal stage was performed which applied the derived variable ‘Last Visit on Treatment’ for comparison to the Pretreatment stage. This post-hoc analysis was judged to be appropriate since triptorelin pamoate 3-month formulation allows release of the active compound over 3 months and beyond this time, pubertal development is expected to progress.|Months 12, 24, 36, 48 and Last Visit on Treatment (if applicable; up to 51 months)|Analysis performed on the ITT population, consisting of all enrolled patients who received at least one injection of study treatment in this follow up study.||percentage of patients|||Number
793855|NCT00909844|Post-Hoc|Percentage of Girls With a Stabilisation or Regression of Tanner Breast Pubertal Stage at the End of the Study (Last Visit on Treatment), Compared to Pretreatment (Month -6) and Baseline (Month 0)|One primary efficacy endpoint was to assess efficacy of triptorelin pamoate 11.25 mg with respect to percentage of girls maintaining a regression or stabilisation of sexual maturity (based on Tanner breast pubertal stage) until end of study. Results reported for this primary endpoint applied the variable ‘Final Visit’ for comparison to Pretreatment and Baseline. Since it was determined that the majority of patients had a Final Visit >3 months after their last injection, a post-hoc analysis of the percentage of girls with regression or stabilisation of Tanner breast pubertal stage was performed which applied the derived variable ‘Last Visit on Treatment’ to compare to the Pretreatment stage and to Baseline. This post-hoc analysis was judged to be appropriate since triptorelin pamoate 3-month formulation allows release of the active compound over 3 months and beyond this time, pubertal development is expected to progress.|Months 12, 24, 36, 48 and Last Visit on Treatment (if applicable; up to 51 months)|Analysis performed on female patients in the ITT population, consisting of all enrolled female patients who received at least one injection of study treatment in this follow up study.||percentage of patients||95% Confidence Interval|Number
793856|NCT00909844|Secondary|Percentage of Children With a Stabilisation or Regression of Tanner Pubic Hair Pubertal Stage at the End of the Study (Final Visit), Compared to Pretreatment (Month -6) and Baseline (Month 0)|Pubic hair was measured by the Tanner method on a scale of 1 to 6. A low grade (i.e. 1) corresponds to a pre-pubertal stage and a high grade (i.e. 5 or 6) to an adult stage. Percentage of patients who had stabilisation or regression (no change in grade or a reduced grade) of Tanner pubic hair pubertal stage is reported. Study treatment was to last until the end of the therapeutic period; visits for Months 36 and 48 were optional because if the girl was already 11 and the boy already 13, they would have finished the study at a prior visit. The Final Visit was to occur only if the child did not end the study by a complete visit such as at Months 24, 36 or 48. Please also note the additional post-hoc analysis for percentage of children with a stabilisation or regression of Tanner pubic hair pubertal stage which applied the variable Last Visit on Treatment instead of Final Visit.|Months 12, 24, 36, 48 and Final Visit (if applicable; up to 63 months)|Analysis performed on the ITT population, consisting of all enrolled patients who received at least one injection of study treatment in this follow up study.||percentage of patients||95% Confidence Interval|Number
793857|NCT00909844|Secondary|Percentage of Girls With a Uterine Length < 36 Millimetres (mm)|Percentage of girls who had a uterine length < 36 mm are reported. It should be noted that only limited patient data was collected after Baseline; all data analysed is presented.|Months -6, 0, 12, 24, 36 and Final Visit (up to 63 months)|Analysis performed on female patients in the ITT population, consisting of all enrolled female patients who received at least one injection of study treatment in this follow up study. Only patients with data available at the timepoint of testing are reported.||percentage of patients||95% Confidence Interval|Number
793858|NCT00909844|Secondary|Bone Age Maturation|Mean change in difference between bone age and chronological age from Pretreatment and from Baseline are reported. It should be noted that only limited patient data was collected after Baseline; all data analysed is presented.|Months -6, 0 and Final Visit (up to 63 months)|Analysis performed on the ITT population, consisting of all enrolled patients who received at least one injection of study treatment in this follow up study. Only patients with data available at the timepoint of testing are reported.||years||Standard Deviation|Mean
793859|NCT00909844|Secondary|Predicted Adult Height SD Score|Mean change of predicted adult height SD score from Pretreatment and from Baseline are reported. SD score is a standard term used in growth studies and represents standard deviations calculated as the patient value minus the mean divided by the SD. SD scores vary depending on the age and sex of the child. It should be noted that only limited patient data was collected after Baseline; all data analysed is presented. Also note that data for this endpoint was analysed for girls only.|Months -6, 0, 12 and Final Visit (up to 63 months)|Analysis performed on female patients in the ITT population, consisting of all enrolled female patients who received at least one injection of study treatment in this follow up study. Only patients with data available at the timepoint of testing are reported.||SD score||Standard Deviation|Mean
793860|NCT00909844|Secondary|Auxological Parameters Variations: Weight Variation|Mean changes of weight from Pretreatment and from Baseline are reported. It should be noted that only limited patient data was collected after Baseline; all data analysed is presented.|Months -6, 0, 12, 24, 36, 48 and Final Visit (up to 63 months)|Analysis performed on the ITT population, consisting of all enrolled patients who received at least one injection of study treatment in this follow up study. Only patients with data available at the timepoint of testing are reported.||kg||Standard Deviation|Mean
793861|NCT00909844|Secondary|Auxological Parameters Variations: Growth Velocity SD Score|Mean changes of growth velocity SD score from Pretreatment and from Baseline are reported. SD score is a standard term used in growth studies and represents standard deviations calculated as the patient value minus the mean divided by the SD. SD scores vary depending on the age and sex of the child. It should be noted that only limited patient data was collected after Baseline; all data analysed is presented.|Months -6, 0, 12, 24, 36, 48 and Final Visit (up to 63 months)|Analysis performed on the ITT population, consisting of all enrolled patients who received at least one injection of study treatment in this follow up study. Only patients with data available at the timepoint of testing are reported.||SD score||Standard Deviation|Mean
793862|NCT00909844|Secondary|Auxological Parameters Variations: Height SD Score|Mean changes of height SD score from Pretreatment and from Baseline are reported. SD score is a standard term used in growth studies and represents standard deviations calculated as the patient value minus the mean divided by the SD. SD scores vary depending on the age and sex of the child. It should be noted that only limited patient data was collected after Baseline; all data analysed is presented.|Months -6, 0, 12, 24, 36, 48 and Final Visit (up to 63 months)|Analysis performed on the ITT population, consisting of all enrolled patients who received at least one injection of study treatment in this follow up study. Only patients with data available at the timepoint of testing are reported.||SD score||Standard Deviation|Mean
793863|NCT00909844|Secondary|BMI Standard Deviation (SD) Score for Chronological Age Variation|Mean changes of BMI SD score from Pretreatment and from Baseline are reported. SD score is a standard term used in growth studies and represents standard deviations calculated as the patient value minus the mean divided by the SD. SD scores vary depending on the age and sex of the child. It should be noted that only limited patient data was collected after Baseline; all data analysed is presented.|Months -6, 0, 12, 24, 36, 48 and Final Visit (up to 63 months)|Analysis performed on the ITT population, consisting of all enrolled patients who received at least one injection of study treatment in this follow up study. Only patients with data available at the timepoint of testing are reported.||SD score||Standard Deviation|Mean
793864|NCT00909844|Secondary|Body Mass Index (BMI) for Chronological Age Variation|Mean changes of BMI from Pretreatment and from Baseline are reported. It should be noted that only limited patient data was collected after Baseline; all data analysed is presented.|Months -6, 0, 12, 24, 36, 48 and Final Visit (up to 63 months)|Analysis performed on the ITT population, consisting of all enrolled patients who received at least one injection of study treatment in this follow up study. Only patients with data available at the timepoint of testing are reported.||kilograms per metre squared (kg/m^2)||Standard Deviation|Mean
793865|NCT00909844|Secondary|Percentage of Patients With a Suppressed Follicle Stimulating Hormone (FSH) Response to GnRH Test|A suppressed FSH response to the GnRH test was defined as a stimulated peak of FSH ≤3 IU/L. Percentage of patients who had a suppressed FSH response to the GnRH test is reported. It should be noted that almost no hormonal data was collected after Baseline; all data analysed is presented.|Months -6, 0 and 36|Analysis performed on the ITT population, consisting of all enrolled patients who received at least one injection of study treatment in this follow up study. Only patients with data available at the timepoint of testing are reported.||percentage of patients||95% Confidence Interval|Number
793866|NCT00909844|Secondary|Levels of Oestradiol in Girls or Testosterone in Boys Both Measured by Radioimmunoassay (RIA)|Mean levels of oestradiol in girls or testosterone in boys are reported. It should be noted that almost no hormonal data was collected after Baseline; all data analysed is presented.|Months -6, 0, 12, 36 and Final Visit (up to 63 months)|Analysis performed on the ITT population, consisting of all enrolled patients who received at least one injection of study treatment in this follow up study. Only patients with data available at the timepoint of testing are reported.||picograms per millilitre (pg/mL)||Standard Deviation|Mean
793867|NCT00909844|Secondary|Percentage of Patients With a Suppressed Luteinizing Hormone (LH) Response to Gonadotropin-Releasing Hormone (GnRH) Test|A suppressed LH response to the GnRH test was defined as a stimulated peak of LH ≤3 international units per litre (IU/L). Percentage of patients who had a suppressed LH response to the GnRH test is reported. It should be noted that almost no hormonal data was collected after Baseline; all data analysed is presented.|Months -6, 0 and 36|Analysis performed on the ITT population, consisting of all enrolled patients who received at least one injection of study treatment in this follow up study. Only patients with data available at the timepoint of testing are reported.||percentage of patients||95% Confidence Interval|Number
793868|NCT00909844|Primary|Percentage of Children With a Stabilisation or Regression of Tanner Pubertal Stage at the End of the Study (Final Visit), Compared to Pretreatment (Month -6) and Baseline (Month 0)|The primary objective was to assess efficacy of triptorelin pamoate 11.25 mg with respect to percentage of children maintaining a regression or stabilisation of sexual maturity (based on Tanner breast [girls] or genital [boys] pubertal stage) until end of study. Study treatment lasted until end of the therapeutic period; visits for Months 36 and 48 were optional since a child may have already finished the study at a prior visit. The Final Visit only occurred if the child did not end the study by a complete visit such as at Months 24, 36 or 48. Results are presented only for percentage of girls with regression or stabilisation of Tanner breast pubertal stage (n=34). Since only one boy was included in the study, results for this outcome measure were listed only and no statistical analysis was performed. Please also note additional post-hoc analysis for regression or stabilisation of Tanner breast pubertal stage which applied the variable Last Visit on Treatment instead of Final Visit.|Months 12, 24, 36, 48 and Final Visit (if applicable; up to 63 months)|Analysis performed on female patients in the ITT population, consisting of all enrolled female patients who received at least one injection of study treatment in this follow up study.||percentage of patients||95% Confidence Interval|Number
793869|NCT00902304|Secondary|Number of Patients With Major Clinical Endpoints|Major clinical endpoints measured were all-cause mortality and fatal and non-fatal cardiovascular events (e.g. acute myocardial infarction, stroke and heart failure).|26 weeks|Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization.||participants|||Number
793870|NCT00902304|Secondary|Rate of Treatment Compliance|The rate of compliance was planned to be estimated from the quantity of unused medication returned at each scheduled visit over the entire follow-up period. Rate of compliance = (tablets supplied - tablets returned)/(tablets for 100% compliance).|26 weeks|This data will not be analyzed due to the poor quality of the data.|||||
793871|NCT00902304|Secondary|Change in Self-care Behavior Score From Baseline to Week 26|A modified self-care behavior tool (questionnaire) was used to calculate 2 domain scales: maintenance and confidence. Each domain has a standardized score between 0 and 100. Self-care is best represented by maintenance. Confidence is an important process that moderates the relationship between self-care and outcomes. Higher index score suggests better self-care. A score of 70 or greater can be used as the cut-point to judge self-care adequacy.|Baseline and week 26|Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization. Only patients with measurements at both baseline and week 26 were included in this analysis.||Change in score||Standard Deviation|Mean
793872|NCT00902304|Secondary|Participants With End Organ Disease at Baseline and Week 26|"A patient was considered to have end organ damage with either of the following: 1) proteinuria (dipstick = 1+ or more or protein/creatinine ratio > 30mg/mol or 24h urine protein > 0.3g); 2) no proteinuria, but presence of microalbuminuria (urine albumin/creatinine ratio 3.6 to 25mg/mol(male) or 3.6 to 35mg/mol (female) detected; 3) no proteinuria or microalbuminuria, but presence of macroalbuminuria (urine albumin/creatinine ratio > 25mg/mol(male) or >35mg/mol (female) detected OR 4) ECG evidence of LVH (Sokolow-Lyon voltage criteria values >= 38mm).
Baseline potential for end organ damage was calculated in all 1562 randomised patients based on the criteria outlined above. If no investigation/data available, assumed no end-organ damage.
It is important to note that given the limited number of ECGs at 26 weeks, between group comparisons should be limited to the two time points (baseline and 26 weeks)."|Baseline and week 26|Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization.||participants|||Number
793873|NCT00902304|Secondary|Change in Center for Epidemiologic Studies Depression (CES-D) Score From Baseline to Week 26|"The CES-D score was from 0 to 30, with a higher score indicating a higher level of depression.
The categories for the score are: 0 to 9 suggests no depression; 10 to 15 suggests mild depression; 16 to 24 suggests moderate depression; 24 or above suggests severe depression."|Baseline and week 26|Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization. Only patients with measurements at both baseline and week 26 were included in this analysis.||change in CES-D score||Standard Deviation|Mean
793874|NCT00902304|Secondary|Number of Patients With Depression|Patients with depression refers to potential depressive symptoms, not clinically diagnosed depression. The 2 question Arrol screening tool was used to determine if the patient had potential depressive symptoms. The 2 questions are: During the last month have you often been bothered by feeling down, depressed or hopeless? During the past month have you often been bothered by little interest or pleasure in doing things? The presence of potential depressive symptoms was determined by a 'yes' answer to either of these questions.|Baseline and week 26|Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization. Only patients with measurements at both baseline and week 26 were included in this analysis.||participants|||Number
793875|NCT00902304|Secondary|Change in the EQ-5D Score|The EQ-5D total indexed score (AUS) measures self-reported quality of life with the following 5 dimensions: mobility (range 1,2,3), self-care (range 1,2,3), usual activity (range 1,2,3), pain/discomfort (range 1,2,3) and anxiety/depression (range 1,2,3), where a 1 indicates no problems, a 2 indicates moderate problems, and a 3 indicates severe problems. The range of possible utility scores are between -0.217 (derived from worse responses from all 5 dimensions with severe problems ie 3,3,3,3,3) and 1.000 (no problems for all 5 dimensions) for each dimension. An increase in EQ-5D indexed score (AUS) indicates improvement.|Baseline and 26 weeks|Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization. Only patients with measurements at both baseline and week 26 were included in this analysis.||change in EQ-5D score||95% Confidence Interval|Mean
793876|NCT00902304|Secondary|Number of 'Early Responder' Patients Who Achieve Individualized Blood Pressure Control After 1 or 2 Adjustments|A comparison of the early responders was made based on the blood pressure measurements taken at the week 6 visit window according to gender and guideline targets. The guideline targets were: patients with renal impairment: 125/75 mmHg; patients with end-organ damage/cardiovascular disease: 130/80 mmHg; others: 140/90 mmHg.|26 weeks|Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization.||Participants|||Number
793877|NCT00902304|Secondary|Number of Patients With at Least One Adverse Events Attributable to Anti-hypertensive Therapy|The rate of all adverse events by preferred terms as determined by the General Practice investigators to be related to study intervention therapy was reported. Percentage of adverse events was calculated based on the number of participants analyzed. 41 adverse events were not reported as inadequate information was supplied to allow determination of drug treatment at onset.|26 weeks|Safety analysis - consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment.||participants|||Number
793878|NCT00902304|Secondary|Change in Absolute Cardiovascular Risk Score|"The absolute cardiovascular risk assessment uses the Framingham Risk Equation to predict risk of a cardiovascular event over the next 5 years. A score of <10% is a low risk, 10 to 15% is a moderate risk, and >15% is a high risk.
A decrease indicates improvement."|Baseline and 26 weeks|Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization. Only patients with measurements at both baseline and week 26 were included in this analysis.||percentage risk score change||Standard Deviation|Mean
793879|NCT00902304|Secondary|Change in Mean Sitting Diastolic Blood Pressure|The visit window was from 22 to 36 weeks. If more than one blood pressure measure was available within the specified window, then the one closest to the scheduled visit was used for analysis. If no measure was available within this window, then the last recorded BP post-randomization was used for the endpoint. Analysis of covariance model was used with the factors: baseline blood pressure, treatment and blood pressure target group at randomization.|Baseline and 26 weeks|Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization. Last Observation Carried Forward (LOCF) imputation technique is used for this analysis.||mmHg||95% Confidence Interval|Least Squares Mean
793892|NCT00902330|Secondary|Relationships Among Biomarkers Log (CRP), Log (IL-1B), Log (IL6), and Log (TNF-a) - Correlations at Midpoint Chemotherapy|Simple correlations will be computed at Midpoint Chemotherapy for the log transformed biomarker values; IL1-β, IL-6, TNF-α, CRP. These are the biomarkers of inflammation.|Midpoint Chemotherapy, up to 4 months|||correlation coefficient|||Number
794289|NCT00905567|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 96 hour period|Data from all subjects who completed the study was used in the statistical analysis.||ng*hr/mL||Standard Deviation|Mean
793880|NCT00902304|Secondary|Change in Mean Sitting Systolic Blood Pressure|The visit window was from 22 to 36 weeks. If more than one blood pressure measure was available within the specified window, then the one closest to the scheduled visit was used for analysis. If no measure was available within this window, then the last recorded BP post-randomization was used for the endpoint. Analysis of covariance model was used with the factors: baseline blood pressure, treatment and blood pressure target group at randomization.|Baseline and 26 weeks|Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization. Last Observation Carried Forward (LOCF) imputation technique is used for this analysis.||mmHg||95% Confidence Interval|Least Squares Mean
793881|NCT00902304|Primary|Percentage of Patients Who Have Achieved Their Pre-specified (Individualized National Heart Foundation of Australia Criteria) Blood Pressure (BP) Target|BP target groups were: <= 125/75mmHg, <= 130/80mmHg and <= 140/90mmHg. The BP target was based on the patient's clinical risk profile as specified by National Heart Foundation of Australia guidelines.|26 weeks|Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization. Last Observation Carried Forward (LOCF) imputation technique is used for this analysis.||percentage of participants|||Number
793882|NCT00902330|Secondary|Relationships Among Quality of Life Scores - Correlations at End of Chemotherapy|Simple correlations will be computed at End of Chemotherapy for quality of life scores.|Up to 2 weeks afer completion of study treatment, for up to 8 months|||correlation coefficient|||Number
793883|NCT00902330|Secondary|Effects of Treatment on Quality of Life - Means at End of Treatment|Measured using the Functional Assessment of Cancer Therapy for Patients with Breast Cancer (FACT-B). A 44-item self-report instrument designed to measure multidimensional quality of life in patient with breast cancer. 0=not at all to 4=very much. Utilized standard questionnaire scoring system. The items are summed to produce a total score 0=not al all to 176=very much. The FACT-B BCA has 10 questions that range from 0 (not at all) to 4 (very much); thus the FACT-B BCA ranges from 0 to 40. Both the FACT-B and FACT-BCA are scored so that high scores indicate higher levels of quality of life.|up to 2 weeks after completion of study treatment, for up to 8 months|||units on a scale||Standard Error|Least Squares Mean
793884|NCT00902330|Secondary|Relationships Among Symptom Scores - Correlations at End of Chemotherapy|Simple correlations will be computed at end of Chemotherapy for symptoms.|Up to 2 weeks afer completion of study treatment, for up to 8 months|||correlation coefficient|||Number
793885|NCT00902330|Secondary|Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at End of Chemotherapy|Measured using Hospital Anxiety and Depression Scale (HADS) a fourteen item scale, 7 relate to anxiety and 7 to depression; each item is scored from 0-3, this means a person can score 0 to 21 for either anxiety or depression (0 is best and 21 is worst), Brief Pain Inventory (BPI) short-form measures the intensity of pain and interference of pain in the patient's life; 12 questions with 0 (does not interfere) to 10 (completely interferes); mean will be used as the measure of pain; Brief Fatigue Inventory (BFI) assess the severity and impact of cancer-related fatigue. it has 9 questions with 0 (does not interfere) to 10 (completely interferes); severe fatigue can be defined as a score of 7 or higher, General Sleep Disturbance Scale (GSDS) 21 items to evaluate sleep issues (0=never to 7=every day); the 21 items are summed to produce a total score of 9=no sleep disturbance to 137=extreme sleep disturbance . Used standard questionnaire scoring system.|Up to 2 weeks afer completion of study treatment, for up to 8 months|||units on a scale||Standard Deviation|Mean
793886|NCT00902330|Secondary|Relationships Among Biomarkers Log (CRP), Log (IL-1B), Log (IL6), and Log (TNF-a) - Correlations at End of Treatment|Simple correlations will be computed at Chemotherapy End of Treatment for the log transformed biomarker values; IL1-β, IL-6, TNF-α, CRP. These are the biomarkers of inflammation.|Up to 2 weeks afer completion of study treatment, for up to 8 months|||correlation coefficient|||Number
793887|NCT00902330|Secondary|Mean and Standard Deviation of Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml).|Simple correlations will be computed after completion of study treatment for the log transformed biomarker values; IL1-β, IL-6, TNF-α, CRP. These are the biomarkers of inflammation.|Up to 2 weeks after completion of study treatment, for up to 8 months|||Log (pg/ml)||Standard Deviation|Mean
793888|NCT00902330|Secondary|Relationships Among Quality of Life Scores - Correlations at Midpoint Chemotherapy|Simple correlations will be computed at Midpoint Chemotherapy for quality of life scores.|Midpoint Chemotherapy, up to 4 months|||correlation coefficient|||Number
793889|NCT00902330|Secondary|Relationships Among Quality of Life Scores - Means at Midpoint Chemotherapy|Measured using the Functional Assessment of Cancer Therapy for Patients with Breast Cancer (FACT-B). A 44-item self-report instrument designed to measure multidimensional quality of life in patient with breast cancer. 0=not at all to 4=very much. Utilized standard questionnaire scoring system. The items are summed to produce a total score 0=not at all to 176=very much. The FACT-B BCA has 10 questions that range from 0 (not at all) to 4 (very much); thus the FACT-B BCA ranges from 0 to 40. Both the FACT-B and FACT-BCA are scored so that high scores indicate higher levels of quality of life.|Midpoint Chemotherapy, up to 4 months|||units on a scale||Standard Deviation|Mean
793890|NCT00902330|Secondary|Relationships Among Symptom Scores - Correlations at Midpoint Chemotherapy|Simple correlations will be computed at Midpoint Chemotherapy for symptoms.|Midpoint Chemotherapy, up to 4 months|||correlation coefficient|||Number
793891|NCT00902330|Secondary|Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at Midpoint Chemotherapy|Measured using Hospital Anxiety and Depression Scale (HADS) a fourteen item scale, 7 relate to anxiety and 7 to depression; each item is scored from 0-3, this means a person can score 0 to 21 for either anxiety or depression (0 is best and 21 is worst), Brief Pain Inventory (BPI) short-form measures the intensity of pain and interference of pain in the patient's life; 12 questions with 0 (does not interfere) to 10 (completely interferes); mean will be used as the measure of pain; Brief Fatigue Inventory (BFI) assess the severity and impact of cancer-related fatigue. it has 9 questions with 0 (does not interfere) to 10 (completely interferes); severe fatigue can be defined as a score of 7 or higher, General Sleep Disturbance Scale (GSDS) 21 items to evaluate sleep issues (0=never to 7=every day); the 21 items are summed to produce a total score of 9=no sleep disturbance to 137=extreme sleep disturbance . Used standard questionnaire scoring system.|Midpoint Chemotherapy, up to 4 months|||units on a scale||Standard Deviation|Mean
793893|NCT00902330|Secondary|Mean and Standard Deviation of Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml).|Simple correlations will be computed at Midpoint Chemotherapy for the log transformed biomarker values; IL1-β, IL-6, TNF-α, CRP. These are the biomarkers of inflammation.|Midpoint Chemotherapy, up to 4 months|||Log (pg/ml)||Standard Deviation|Mean
793894|NCT00902330|Secondary|Relationships Among Quality of Life Scores - Correlations at Baseline|Simple correlations will be computed at Baseline for quality of life scores.|Baseline|||correlation coefficient|||Number
793895|NCT00902330|Secondary|Relationships Among Quality of Life Scores - Means at Baseline|Measured using the Functional Assessment of Cancer Therapy for Patients with Breast Cancer (FACT-B). A 44-item self-report instrument designed to measure multidimensional quality of life in patient with breast cancer. 0=not at all to 4=very much. Utilized standard questionnaire scoring system. The items are summed to produce a total score 0=not at all to 176=very much. The FACT-B BCA has 10 questions that range from 0 (not at all) to 4 (very much); thus the FACT-B BCA ranges from 0 to 40. Both the FACT-B and FACT-BCA are scored so that high scores indicate higher levels of quality of life.|Baseline|||units on a scale||Standard Deviation|Mean
793896|NCT00902330|Secondary|Relationships Among Symptom Scores - Correlations at Baseline Chemotherapy|Simple correlations will be computed at Baseline Chemotherapy for symptoms.|Baseline|||correlation coefficient|||Number
793897|NCT00902330|Secondary|Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at Baseline|Measured using Hospital Anxiety and Depression Scale (HADS) a fourteen item scale, 7 relate to anxiety and 7 to depression; each item is scored from 0-3, this means a person can score 0 to 21 for either anxiety or depression (0 is best and 21 is worst), Brief Pain Inventory (BPI) short-form measures the intensity of pain and interference of pain in the patient's life; 12 questions with 0 (does not interfere) to 10 (completely interferes); mean will be used as the measure of pain; Brief Fatigue Inventory (BFI) assess the severity and impact of cancer-related fatigue. it has 9 questions with 0 (does not interfere) to 10 (completely interferes); severe fatigue can be defined as a score of 7 or higher, General Sleep Disturbance Scale (GSDS) 21 items to evaluate sleep issues (0=never to 7=every day); the 21 items are summed to produce a total score of 9=no sleep disturbance to 137=extreme sleep disturbance . Used standard questionnaire scoring system.|Baseline|||units on a scale||Standard Deviation|Mean
793898|NCT00902330|Secondary|Relationships Among Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml).|Simple correlations will be computed at Baseline for the log transformed biomarker values; IL1-β, IL-6, TNF-α, CRP. These are the biomarkers of inflammation.|Baseline|||correlation coefficient|||Number
793899|NCT00902330|Secondary|Means and Standard Deviations of Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml).|Simple correlations will be computed at Midpoint Chemotherapy for the log transformed biomarker values; IL1-β, IL-6, TNF-α, CRP. These are the biomarkers of inflammation.|Baseline|Per protocol, for all subjects with available data. No imputation was utilized.||Log(pg/ml)||Standard Deviation|Mean
793900|NCT00902330|Secondary|To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster.|Examine correlations between the symptoms at baseline to determine a general pattern of association. Factor analysis (a statistical method used to describe variability among observed, correlated variables in terms of a potentially lower number of unobserved variables called factors) was performed to examine how these 5 symptoms cluster. A principal component factor analysis was performed on the correlation matrix for the symptom scores of anxiety, depression, pain, fatigue and sleep disturbance at up to two weeks after completion of study treatment, up to 8 months). For each analysis two factors were retained that explained 74% of the variability for the baseline symptom scores, 79% of the variability of the symptom scores at the midpoint and 78% of the variability in symptom scores at study completion. A varimax rotation was utilized and the factor loadings from the varimax rotation were reported.|up to 2 weeks after completion of study treatment, for up to 8 months|||Rotated factor loading multiplied by 100|||Number
793901|NCT00902330|Primary|Effects of CES as Compared to Sham CES on Symptoms of Depression, Anxiety, Fatigue, Pain and Sleep Disturbances in Women Receiving Adjuvant Chemotherapy for Early-stage Breast Cancer|Using Hospital Anxiety and Depression Scale (HADS) a 14 item scale, 7 relate to anxiety, 7 to depression; each item is scored from 0-3, a person can score 0 to 21 for either anxiety or depression (0 is best and 21 is worst), Brief Pain Inventory (BPI) short-form measures the intensity and interference of pain in the patient's life; 12 questions with 0 (does not interfere) to 10 (completely interferes); mean will be used as the measure of pain; Brief Fatigue Inventory (BFI) assess the severity and impact of cancer-related fatigue. Has 9 questions with 0 (does not interfere) to 10 (completely interferes), the total mean score is the mean of the 9 questions; severe fatigue can be defined as a score of 7 or higher, General Sleep Disturbance Scale (GSDS) 21 items to evaluate sleep issues (0=never to 7=every day); the 21 items are summed to produce a total score of 9=no sleep disturbance to 137=extreme sleep disturbance . Used standard questionnaire|Up to 2 weeks afer completion of study treatment, for up to 8 months|||units on a scale||Standard Deviation|Least Squares Mean
793902|NCT00902538|Secondary|In Non-responders, the Change in 24-hour Systolic Blood Pressure Assessed by 24-hour Ambulatory Blood Pressure Measurement.|In non-responders, the change in 24-hour systolic blood pressure assessed by 24-hour ambulatory blood pressure measurement from the beginning to the end of Period 4.|Week 16 to week 32|The analysis population includes those participants who had blood pressure values at both the beginning and end of Period 4.||mm Hg||Standard Error|Least Squares Mean
793903|NCT00902538|Secondary|In Non-responders, the Change in 24-hour Diastolic Blood Pressure Assessed by 24-hour Ambulatory Blood Pressure Measurement.|In non-responders, the change in 24-hour diastolic blood pressure assessed by 24-hour ambulatory blood pressure measurement from the beginning to the end of Period 4.|Week 16 to week 32|The analysis population includes those participants who had blood pressure values at both the beginning and end of Period 4.||mm Hg||Standard Error|Least Squares Mean
793904|NCT00902538|Secondary|In Non-responders, the Number of Subject Meeting Their Blood Pressure Goals Associated With the Triple Combinations OM/AML/HCTZ 40/10/12.5 and 40/10/25 mg.|The number of non-responding participants who achieved their blood pressure goals at the end of Period 4. Achieving blood pressure goal is defined as seated blood pressure <140/90 mm Hg; 130/80 mm Hg for participants with diabetes and/or other chronic renal and/or chronic cardiovascular disease. Three cuff blood pressure measurements were taken at each visit.|week 24 to week 32|The analysis population includes those participants who had blood pressure values at both the beginning and end of Period 4.||Participants|||Number
793905|NCT00902538|Secondary|In Non-responders, the Change in Seated Systolic Blood Pressure Associated With the Triple Combinations OM/AML/HCTZ 40/10/12.5 and 40/10/25 mg.|Change in seated systolic blood pressure from the beginning to the end of Period 4. Three cuff blood pressure measurements were taken at each visit.|week 24 to week 32|The analysis population includes those participants who had blood pressure values at both the beginning and end of Period 4.||mm Hg||Standard Error|Least Squares Mean
793906|NCT00902538|Secondary|In Non-responders, the Change in Seated Diastolic Blood Pressure Associated With the Triple Combinations OM/AML/HCTZ 40/10/12.5 and 40/10/25 mg.|Change in seated diastolic blood pressure from the beginning to the end of Period 4. Three cuff blood pressure measurements were taken at each visit.|week 24 to week 32|The analysis population includes those participants who had blood pressure values at both the beginning and end of Period 4.||mm Hg||Standard Error|Least Squares Mean
793907|NCT00902538|Secondary|Change in 24-hour Systolic Blood Pressure Assessed by 24-hour Ambulatory Blood Pressure Measurement.|Three cuff blood pressure measurements were taken at each visit.|Baseline (8 weeks) to 16 weeks|The Full Analysis Set 1 included 806 randomized subjects who received at least 1 dose of double-blind study medication in Period II and provided at least 1 SeDBP measurement in Period II: 269 subjects in the OM/AML 40/10 mg group, 268 subjects in the OM/AML/HCTZ 40/10/12.5 mg group, and 269 subjects in the OM/AML/HCTZ 40/10/25 mg group.||mm Hg||Standard Error|Least Squares Mean
793908|NCT00902538|Secondary|Change in 24-hour Diastolic Blood Pressure (DBP) Assessed by 24-hour Ambulatory Blood Pressure Measurement (ABPM).|Three cuff blood pressure measurements were taken at each visit.|Baseline (8 weeks) to 16 weeks|The Full Analysis Set 1 included 806 randomized subjects who received at least 1 dose of double-blind study medication in Period II and provided at least 1 SeDBP measurement in Period II: 269 subjects in the OM/AML 40/10 mg group, 268 subjects in the OM/AML/HCTZ 40/10/12.5 mg group, and 269 subjects in the OM/AML/HCTZ 40/10/25 mg group.||mm Hg||Standard Error|Least Squares Mean
793909|NCT00902538|Secondary|Number of Subjects Achieving Blood Pressure (BP) Goal at Week 16.|Achieving blood pressure goal is defined as seated blood pressure <140/90 mm Hg; 130/80 mm Hg for participants with diabetes and/or other chronic renal and/or chronic cardiovascular disease. Three cuff blood pressure measurements were taken at each visit.|baseline (week 8) to week 16|The Full Analysis Set 1 included 806 randomized subjects who received at least 1 dose of double-blind study medication in Period II and provided at least 1 SeDBP measurement in Period II: 269 subjects in the OM/AML 40/10 mg group, 268 subjects in the OM/AML/HCTZ 40/10/12.5 mg group, and 269 subjects in the OM/AML/HCTZ 40/10/25 mg group.||Participants|||Number
793910|NCT00902538|Secondary|Change in Seated Systolic Blood Pressure (SeSBP) of the Triple Combinations OM/AML/HCTZ 40/10/12.5 and 40/10/25 mg vs. OM/AML 40/10 mg|Three cuff blood pressure measurements were taken at each visit.|baseline (8 weeks) to week 16|The Full Analysis Set 1 included 806 randomized subjects who received at least 1 dose of double-blind study medication in Period II and provided at least 1 SeDBP measurement in Period II: 269 subjects in the OM/AML 40/10 mg group, 268 subjects in the OM/AML/HCTZ 40/10/12.5 mg group, and 269 subjects in the OM/AML/HCTZ 40/10/25 mg group.||mm Hg||Standard Error|Least Squares Mean
793911|NCT00902538|Primary|Change in Seated Diastolic Blood Pressure (SeDBP) of the Triple Combinations OM/AML/HCTZ 40/10/12.5 and 40/10/25 mg vs. OM/AML 40/10 mg|Three cuff blood pressure measurements were taken at each visit.|baseline (8 weeks) to 16 weeks|The Full Analysis Set 1 included 806 randomized subjects who received at least 1 dose of double-blind study medication in Period II and provided at least 1 SeDBP measurement in Period II: 269 subjects in the OM/AML 40/10 mg group, 268 subjects in the OM/AML/HCTZ 40/10/12.5 mg group, and 269 subjects in the OM/AML/HCTZ 40/10/25 mg group.||mm Hg||Standard Error|Least Squares Mean
793912|NCT00902564|Secondary|Percentage of Patients Who Responded According to >= 50% Improvement From Baseline to Week 8 in HAMA Total Score|The HAMA is a 14-item rating scale designed to assess global anxiety symptoms. Each symptom is rated from 0 (absent) to 4 (severe). The total score of the 14 items ranges from 0 to 56.|baseline and 8 weeks|Observed Cases (OC)||percentage of patients|||Number
793913|NCT00902564|Secondary|Effect of Escitalopram After 8 Weeks Using Sheehan Disability Scale (SDS) Social|The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scale, on which 0 = normal functioning and 10 = severe functional impairment.|baseline and 8 weeks|||scores on a scale||Standard Deviation|Mean
793914|NCT00902564|Secondary|Effect of Escitalopram After 8 Weeks Using Sheehan Disability Scale (SDS) Family|The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scale, on which 0 = normal functioning and 10 = severe functional impairment.|baseline and 8 weeks|||scores on a scale||Standard Deviation|Mean
793915|NCT00902564|Secondary|Effect of Escitalopram After 8 Weeks Using Sheehan Disability Scale (SDS) Work|The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scale, on which 0 = normal functioning and 10 = severe functional impairment.|baseline and 8 weeks|||scores on a scale||Standard Deviation|Mean
793916|NCT00902564|Secondary|Percentage of Patients Who Achieved Remission After 8 Weeks of Treatment Using CGI-S <= 2|The CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients).|baseline and 8 weeks|||percentage of patients|||Number
793917|NCT00902564|Secondary|Percentage of Patients Who Responded to Escitalopram After 8 Weeks of Treatment Using CGI-I <= 2|The CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).|baseline and 8 weeks|||percentage of patients|||Number
793918|NCT00902564|Secondary|Effect of Escitalopram After 8 Weeks Using the Clinical Global Impression (CGI-S)|The CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients).|baseline and 8 weeks|||scores on a scale||Standard Deviation|Mean
793919|NCT00902564|Secondary|Effect of Escitalopram After 8 Weeks Using the Clinical Global Impression (CGI-I)|The CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).|baseline and 8 weeks|||scores on a scale||Standard Deviation|Mean
793920|NCT00902564|Primary|Effect of Escitalopram After 8 Weeks of Treatment in Patients With GAD Using the Hamilton Anxiety Scale (HAMA)|The HAMA is a 14-item rating scale designed to assess global anxiety symptoms. Each symptom is rated from 0 (absent) to 4 (severe). The total score of the 14 items ranges from 0 to 56.|baseline and 8 weeks|||scores on a scale||Standard Deviation|Mean
793921|NCT00909857|Secondary|Bodily Pain as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination|The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)|At final examination (28 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
793922|NCT00909857|Secondary|Bodily Pain as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle|The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)|At baseline cycle (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
793923|NCT00909857|Secondary|Role Emotional as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination|The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)|At final examination (28 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
793924|NCT00909857|Secondary|Role Emotional as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle|The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)|At baseline cycle (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
793925|NCT00909857|Secondary|Role Physical as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination|The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)|At final examination (28 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
793926|NCT00909857|Secondary|Role Physical as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle|The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)|At baseline cycle (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
793927|NCT00909857|Secondary|General Health as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination|The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)|At final examination (28 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
793947|NCT00909857|Secondary|Own Costs of Physiotherapy Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire|The participants were asked to complete a resource use questionnaire indicating their own costs of physiotherapy per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.|At screening (average over 3 months before screening)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Dollars||Full Range|Median
793928|NCT00909857|Secondary|General Health as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle|The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)|At baseline cycle (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
793929|NCT00909857|Secondary|Vitality as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination|The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)|At final examination (28 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
793930|NCT00909857|Secondary|Vitality as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle|The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)|At baseline cycle (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
793931|NCT00909857|Secondary|Mental Health as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination|The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)|At final examination (28 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
793932|NCT00909857|Secondary|Mental Health as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle|The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)|At baseline cycle (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants wit assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
793933|NCT00909857|Secondary|Social Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination|The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)|At final examination (28 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
793934|NCT00909857|Secondary|Social Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle|The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)|At baseline cycle (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
793935|NCT00909857|Secondary|Physical Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination|The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)|at final examination (28 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
793948|NCT00909857|Secondary|Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Final Examination|The investigator was asked to interview the participant and record the number of missed hours/days from work due to dysmenorrheic pain in the previous menstrual cycle.|At final examination (28 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Percentage of Participants|||Number
793936|NCT00909857|Secondary|Physical Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle|The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)|At baseline cycle (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
793937|NCT00909857|Secondary|Participants With Improvement in Participants' Assessment in the Clinical Global Impression|The Clinical Global Impression Scale (CGI) is a widely used rating scale/assessment instrument in psychopharmacology research in general, and in studies on women’s health in particular. Participants were asked to rate their improvement during the course of the study.|At cycle 2 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Participants|||Number
793938|NCT00909857|Secondary|Participants With Improvement in the Investigators' Assessment in the Clinical Global Impression|The Clinical Global Impression Scale (CGI) is a widely used rating scale/assessment instrument in psychopharmacology research in general, and in studies on women’s health in particular. Investigators were asked to rate the participants' improvement during the course of the study.|At cycle 2 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Participants|||Number
793939|NCT00909857|Secondary|Other Own Costs Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire|The participants were asked to complete a resource use questionnaire indicating their other own costs per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.|At screening (average over 3 months before screening)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Dollars||Full Range|Median
793940|NCT00909857|Secondary|Own Costs of Herbs/Teas Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire|The participants were asked to complete a resource use questionnaire indicating their own costs of herbs/teas per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.|At screening (average over 3 months before screening)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Dollars||Full Range|Median
793941|NCT00909857|Secondary|Own Costs of Alternative Medicine Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire|The participants were asked to complete a resource use questionnaire indicating their own costs of alternative medicine per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.|At screening (average over 3 months before screening)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Dollars||Full Range|Median
793942|NCT00909857|Secondary|Own Costs of Medical Counseling Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire|The participants were asked to complete a resource use questionnaire indicating their own costs of medical counseling per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.|At screening (average over 3 months before screening)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Dollars||Full Range|Median
793943|NCT00909857|Secondary|Own Costs of Acupuncture Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire|The participants were asked to complete a resource use questionnaire indicating their own costs of acupuncture per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.|At screening (average over 3 months before screening)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Dollars||Full Range|Median
793944|NCT00909857|Secondary|Own Costs of Massages Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire|The participants were asked to complete a resource use questionnaire indicating their own costs of massages per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.|At screening (average over 3 months before screening)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Dollars||Full Range|Median
793945|NCT00909857|Secondary|Own Costs of Vitamins Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire|The participants were asked to complete a resource use questionnaire indicating their own costs of vitamins per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.|At screening (average over 3 months before screening)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Dollars||Full Range|Median
793946|NCT00909857|Secondary|Own Costs of Pain Medication Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire|The participants were asked to complete a resource use questionnaire indicating their own costs of pain medication per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.|At screening (average over 3 months before screening)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Dollars||Full Range|Median
793949|NCT00909857|Secondary|Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Cycle 2|The investigator was asked to interview the participant and record the number of missed hours/days from work due to dysmenorrheic pain in the previous menstrual cycle.|At cycle 2 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Percentage of Participants|||Number
793950|NCT00909857|Secondary|Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Baseline Cycle|The investigator was asked to interview the participant and record the number of missed hours/days from work due to dysmenorrheic pain in the previous menstrual cycle.|At Baseline (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Percentage of Participants|||Number
793951|NCT00909857|Secondary|Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Screening|The investigator was asked to interview the participant and record the number of missed hours/days from work due to dysmenorrheic pain in the previous menstrual cycle.|At screening (28 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available||Percentage of Participants|||Number
793952|NCT00909857|Secondary|Percentage of Participants With Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3|Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. Intensity could be described as spotting, light, normal or heavy.|At cycle 3 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Percentage of participants|||Number
793953|NCT00909857|Secondary|Percentage of Participants With Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1|Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. Intensity could be described as spotting, light, normal or heavy.|At cycle 1 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Percentage of participants|||Number
793954|NCT00909857|Secondary|Number of Intracyclic Bleeding Days at Cycle 3|Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. The total number of days during intracyclic bleeding episodes was counted.|At cycle 3 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Days||Standard Deviation|Mean
793955|NCT00909857|Secondary|Number of Intracyclic Bleeding Days at Cycle 1|Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. The total number of days during intracyclic bleeding episodes was counted.|At cycle 1 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Days||Standard Deviation|Mean
793956|NCT00909857|Secondary|Maximum Length of Intracyclic Bleeding Episodes at Cycle 3|Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.|At cycle 3 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Days||Standard Deviation|Mean
793957|NCT00909857|Secondary|Maximum Length of Intracyclic Bleeding Episodes at Cycle 1|Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.|At cycle 1 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Days||Standard Deviation|Mean
793958|NCT00909857|Secondary|Number of Intracyclic Bleeding Episodes at Cycle 3|Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.|At cycle 3 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Episodes||Standard Deviation|Mean
793959|NCT00909857|Secondary|Number of Intracyclic Bleeding Episodes at Cycle 1|Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.|At cycle 1 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Episodes||Standard Deviation|Mean
793960|NCT00909857|Secondary|Percentage of Participants With Intracyclic Bleeding at Cycle 3|Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.|At cycle 3 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Percentage of Participants|||Number
793961|NCT00909857|Secondary|Percentage of Participants With Intracyclic Bleeding at Cycle 1|Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.|At cycle 1 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Percentage of Participants|||Number
793962|NCT00909857|Secondary|Onset of Withdrawal Bleeding Episodes at Cycle 3|Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.|At cycle 3 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Days||Standard Deviation|Mean
793963|NCT00909857|Secondary|Onset of Withdrawal Bleeding Episodes at Cycle 1|Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.|At cycle 1 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Days||Standard Deviation|Mean
793964|NCT00909857|Secondary|Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3|Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. Intensity was defined as: 1 = none, 2 = spotting, 3 = light, 4 = normal, 5 = heavy.|At cycle 3 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
793965|NCT00909857|Secondary|Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1|Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. Intensity was defined as: 1 = none, 2 = spotting, 3 = light, 4 = normal, 5 = heavy.|At cycle 1 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
793966|NCT00909857|Secondary|Length of Withdrawal Bleeding Episodes at Cycle 3|Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.|At cycle 3 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Days||Standard Deviation|Mean
793967|NCT00909857|Secondary|Length of Withdrawal Bleeding Episodes at Cycle 1|Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.|At cycle 1 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Days||Standard Deviation|Mean
793968|NCT00909857|Secondary|Percentage of Participants With Withdrawal Bleeding at Cycle 3|Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.|At cycle 3 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Percentage of Participants|||Number
793969|NCT00909857|Secondary|Percentage of Participants With Withdrawal Bleeding at Cycle 1|Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.|At cycle 1 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Percentage of Participants|||Number
793970|NCT00909857|Secondary|Difference in Duration Between Longest and Shortest Spotting Only Episode|Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject’s experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.|From day 1 to day 90|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Days||Standard Deviation|Mean
793971|NCT00909857|Secondary|Maximum Length of Spotting Only Episodes|Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject’s experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.|From day 1 to day 90|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Days||Standard Deviation|Mean
793972|NCT00909857|Secondary|Mean Length of Spotting Only Episodes|Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject’s experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.|From day 1 to day 90|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Days||Standard Deviation|Mean
793973|NCT00909857|Secondary|Number of Episodes With Spotting-only|Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject’s experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.|From day 1 to day 90|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Episodes||Standard Deviation|Mean
794290|NCT00905567|Primary|AUC0-72 - Area Under the Concentration Time Curve From Time Zero to Time 72 Hours (Per Participant)|Bioequivalence based on AUC0-72|Blood samples collected over 96 hour period|Data from all subjects who completed the study was included in the statistical analysis.||ng*hr/mL||Standard Deviation|Mean
793974|NCT00909857|Secondary|Number of Days With Spotting-only|Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject’s experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.|From day 1 to day 90|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Days||Standard Deviation|Mean
793975|NCT00909857|Secondary|Difference in Duration Between Longest and Shortest Bleeding or Spotting Episode|Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject’s experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.|From day 1 to day 90|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Days||Standard Deviation|Mean
793976|NCT00909857|Secondary|Maximum Length of Bleeding or Spotting Episodes|Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject’s experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.|From day 1 to day 90|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Days||Standard Deviation|Mean
793977|NCT00909857|Secondary|Mean Length of Bleeding or Spotting Episodes|Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject’s experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.|From day 1 to day 90|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Days||Standard Deviation|Mean
793978|NCT00909857|Secondary|Number of Episodes With Bleeding or Spotting|Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject’s experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.|From day 1 to day 90|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Episodes||Standard Deviation|Mean
793979|NCT00909857|Secondary|Number of Days With Bleeding or Spotting|Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject’s experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.|From day 1 to day 90|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Days||Standard Deviation|Mean
793980|NCT00909857|Secondary|Percentage of Participants Satisfied With Study Treatment|Participants were asked to express the degree of their satisfaction with study treatment.|From cycle 1 to cycle 3 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Percentage of participants|||Number
793981|NCT00909857|Secondary|Percentage of Participants With Interference of Dysmenorrheic Pain With Work/School and Social or Other Activity (Entire Evaluation Period Used)|Interference of dysmenorrheic pain with work/school and social or other activity was assessed (yes/no). Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).|baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available||Percentage of Participants|||Number
794006|NCT00910091|Secondary|Percentage of Participants With First Documentation of Objective Tumour Progression From Randomisation||Up to 2 years|ITT population.||Percentage of Participants||Standard Deviation|Mean
793982|NCT00909857|Secondary|Percentage of Participants With Interference of Dysmenorrheic Pain With Work/School and Social or Other Activity (Only Bleeding Episodes Used Including the Two Days Before)|Interference of dysmenorrheic pain with work/school and social or other activity was assessed (yes/no). Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).|baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available||Percentage of participants|||Number
793983|NCT00909857|Secondary|Change Between Baseline Evaluation Period and Treatment Evaluation Period in Rescue Medication Use (Entire Evaluation Period Used)|Rescue medication use was standardized intake of 200 mg Ibuprofen tablets. Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).|baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Tablets||Standard Deviation|Mean
793984|NCT00909857|Secondary|Change Between Baseline Evaluation Period and Treatment Evaluation Period in Rescue Medication Use (Only Bleeding Episodes Used Including the Two Days Before the Episode)|Rescue medication use was standardized intake of 200 mg Ibuprofen tablets. Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).|baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Tablets||Standard Deviation|Mean
793985|NCT00909857|Secondary|Change Between Baseline Evaluation Period and Treatment Evaluation Period in Number of Days With Pelvic Pain During Unscheduled Bleeding|Evaluated was the number of days with bleeding-associated pelvic pain, excluding days during withdrawal bleeding (WB) and the 2 days preceding such WB, and during administration deviation bleeding and the 2 days preceding such bleeding (normalized to a standard 56-day period). Baseline period: 2 days before first menstrual bleeding until 3rd day before 3rd menstrual bleeding (normalized to standard 56-day period). Treatment period: 2 days before WB of the 1st treatment cycle until 3rd day before the WB of the cycle after the 2nd treatment cycle (normalized to standard 56-day period).|baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Days||Standard Deviation|Mean
793986|NCT00909857|Secondary|Change Between Baseline Evaluation Period and Treatment Evaluation Period in Number of Days With Pelvic Pain Independent of Occurrence of Vaginal Bleeding|Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).|baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Days||Standard Deviation|Mean
793987|NCT00909857|Secondary|Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Sum of Score Points of Dysmenorrheic Pain|Dysmenorrheic pain: pelvic pain during menstrual/withdrawal bleeding (WB) episode and 2 days before. Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Baseline period: 2 days before 1st menstrual bleeding until 3rd day before 3rd menstrual bleeding (normalized to standard 56-day period). Treatment period: 2 days before WB of 1st treatment cycle until 3rd day before WB of the cycle after 2nd treatment cycle (normalized to standard 56-day period). Score difference min -168 (best), max 168 (worst)|baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
793988|NCT00909857|Primary|Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Number of Days With Dysmenorrheic Pain|Dysmenorrheic pain was defined as pelvic pain during the menstrual/withdrawal bleeding episode and the 2 days before this episode. Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).|baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Days||Standard Deviation|Mean
793992|NCT00910000|Secondary|Response|Response was based on RECIST 1.0 criteria. Per RECIST 1.0 for target lesions, complete response (CR) is complete disappearance of all target lesions and partial response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. Progressive disease (PD) is at least a 20% increase in sum LD from the smallest LD recorded on treatment. Stable disease (SD) is neither sufficient increase to qualify as PD nor sufficient shrinkage to qualify for PR. For CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed 4 weeks +/- 2 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. Participants who received therapy but did not have their disease re-evaluated were considered unevaluable.|Disease was assessed radiographically (CT or MRI scan) every 2 cycles on treatment; Phase Ib participants received up to 8 cycles of treatment. The median number of cycles started was 2 (range 1-8).|||participants|||Number
793993|NCT00910000|Primary|Dose Limiting Toxicity (DLT) [Phase Ib]|"Dose-limiting toxicity was based on the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) and defined as any of the following:
Any CTCAE grade 3 or 4 non-hematologic event except manageable gastrointestinal toxicity and fatigue.
Any of the following hematologic events (excluding neutropenia lasting < 5 days):
i) febrile neutropenia defined as grade 3-4 neutropenia with fever ≥ 38.5°C and/or infection.
ii) any grade 4 neutropenia lasting 5 days or more. iii) grade 4 thrombocytopenia (plt count < 25x 109/L) iv) failure of ANC to recover to ≥ 1000/μL or platelets to recover to ≥ 50,000/μL within 14 days of therapy v) grade 4 anemia
Any clinically significant abnormal laboratory value that results in dose delay of >14 days.
<75% of vorinostat dosing taken by the patient during the first cycle due to any toxicity."|The DLT observation period in determining the MTD was the 21-day cycle 1 length.|Per protocol, DLT evaluable participants received day 1 of treatment, were not taken off study during cycle 1 due to disease progression, showed proof via pill diary that all doses of vorinostat were taken or attempted to be taken and were compliant with study procedures. The final DLT dataset was comprised of all enrolled and treated participants.||participants with DLT|||Number
793994|NCT00910000|Primary|Vorinostat Maximum Tolerated Dose (MTD) [Phase Ib]|The Vorinostat MTD is determined by the number of patients who experience a dose limiting toxicity (DLT). See subsequent primary outcome measure for the DLT definition. The MTD is defined as the highest dose at which fewer than one-third of patients experience a DLT. If no DLTs are observed, the MTD is not reached.|The DLT observation period in determining the MTD was the 21-day cycle 1 length.|Per protocol, MTD evaluable participants received day 1 of treatment, were not taken off study during cycle 1 due to disease progression, showed proof via pill diary that all doses of vorinostat were taken or attempted to be taken and were compliant with study procedures. The final MTD dataset was comprised of all enrolled and treated participants.||mg/day|||Number
793995|NCT00910039|Secondary|Safety and Tolerability|Number of patients that experienced treatment-related G 3-4 adverse events.|3 years from study start|||participants|||Number
793996|NCT00910039|Secondary|Neurocognitive Effects|The number of patients that had statistically significant change (p’s > 0.05) in their neurocognitive assessment (improvement or decline) from baseline. Neurocognitive function was assessed in several domains, including memory, verbal fluency, visual-motor speed, executive function and motor dexterity.The difference between the pre-treatment baseline and follow-up assessment scores were determined by the reliable change (RC) index. RC Index: 1=deterioration, 2=no change, 3=improved|at 2 months after treatment|Due to the small number of patients accrued there was not enough data for analysis of this outcome.|||||
793997|NCT00910039|Secondary|Rate of Local Failure at 12 Months|Rate of local vs regional failure –rates of progression at site of stereotactic radiosurgery (local failure)vs progression anywhere else in CNS (regional failure).|12 months|Due to the small number of patients accrued there was not enough data for analysis of this outcome.|||||
793998|NCT00910039|Secondary|Time to Progression|Time to progression (all sites of disease) - interval between stereotactic radiosurgery and the earliest date of progression (systemic or CNS) or death due to any cause.|at 3 yrs from SRS|||months||95% Confidence Interval|Median
793999|NCT00910039|Secondary|Overall Survival|The number of subjects surviving at least 12 months from stereotactic radiosurgery.|12 months from SRS|Intent to treat||participants|||Number
794000|NCT00910039|Secondary|Median Time to CNS Disease Progression|Time to disease progression will be recorded from the first day of protocol therapy until the criteria for disease progression are met, patient death from any cause or removal of the patient from study for any reason, whichever comes first.|up to12 months from SRS|Intent to treat||months||95% Confidence Interval|Median
794001|NCT00910039|Secondary|Central Nervous System (CNS) Progression-free Survival Rate|The number of subjects surviving at least 12 months from SRS without progressive disease anywhere in the brain (local or regional failure), assessed by the McDonald’s standard criteria. Progressive neurologic abnormalities not explained by causes unrelated to tumor progression (e.g. anticonvulsant or corticosteroid toxicity, electrolyte abnormalities, hyperglycemia, etc.) or a greater than 25% increase in the size of the tumor by MRI/CT scan.|12 months after stereotactic radiosurgery (SRS)|Intent to treat||participants|||Number
794002|NCT00910039|Primary|Central Nervous System (CNS) Progression-free Survival Rate|The number of subjects surviving at least six months from SRS without progressive disease anywhere in the brain (local or regional failure), assessed by the McDonald’s standard criteria.Progressive neurologic abnormalities not explained by causes unrelated to tumor progression (e.g. anticonvulsant or corticosteroid toxicity, electrolyte abnormalities, hyperglycemia, etc.) or a greater than 25% increase in the size of the tumor by MRI/CT scan.|6 months after stereotactic radiosurgery (SRS)|Intent to treat||participants|||Number
794003|NCT00910091|Secondary|Progression Free Survival (PFS): Time From Randomisation Until Objective Tumour Progression or Death From Any Cause||Up to 2 years|||Weeks||90% Confidence Interval|Median
794004|NCT00910091|Secondary|Overall Survival (OS)|OS is defined as the time from the date of enrollment to the date of death due to any cause.|At 2 years|ITT population.||Weeks||90% Confidence Interval|Median
794005|NCT00910091|Secondary|Duration of Response (DR) in Responders|DR is defined as period from the time that measurement criteria are first met for CR or PR until first date of documented Progressive Disease (PD) or death. DR was assessed in participants with a best overall response of CR or PR.|At 2 years|ITT population.||Weeks||90% Confidence Interval|Median
794008|NCT00910091|Secondary|Percentage of Participants With Clinical Benefit [Including Completed Response (CR), Partial Response (PR), and Stable Disease (SD)] ≥12 Weeks|"CR: Disappearance of all known disease & no new sites / disease related symptoms confirmed at least 12 weeks after initial documentation. Disappearance of all non-target lesions. Normalization of tumor marker level confirmed at least 12 weeks after initial documentation.
PR: Minimum 30% decrease in sum of the longest diameters of target lesions, taking as a reference the baseline sum of the longest diameters confirmed at least 12 weeks after initial documentation. PR is also recorded when all measurable disease has completely disappeared, but a non-measurable component (i.e., ascites) is still present but not progressing. As well as persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above normal limits.
RECIST defines SD for target lesions as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, no occurrence of progression disease for non-target lesions, and no new lesions."|Up to 2 years|ITT population.||Percentage of Participants||Standard Deviation|Mean
794009|NCT00910091|Secondary|Percentage of Participants >65 Years of Age With No Change or Deterioration, Improvement of <10%, or Improvement of ≥10% on the EuroQoL Score|EuroQoL (Quality of Life)-5 Dimensions (EQ-5D) is a participant answered questionnaire scoring 5 dimensions: Mobility, self-care, usual activities, pain/discomfort and anxiety/depression. EQ-5D total score ranges from 0 (worst health state) to 1 (perfect health state) and 1 reflects the best outcome.|Up to week 32|"ITT population.
Three subjects withdrawn the consent from MA 160 mg group and did not have EuroQoL score up to week 32."||Percentage of participants|||Number
794010|NCT00910091|Secondary|Tolerability of BN83495 Based on Dose Interruptions and Reason for Interruptions|Percentage of participants who had dose interruptions and reason for interruptions as AE, study treatment forgotten, and other reasons.|Up to 2 years|Safety Population||Percentage of participants|||Number
794011|NCT00910091|Secondary|Tolerability of BN83495 Based on Cumulative Dose Administered|Cumulative dose is the actual total dose administered.|Up to 2 years|"Safety Population
Missing number of subjects = 2"||mg||Standard Deviation|Mean
794012|NCT00910091|Secondary|Tolerability of BN83495 Based on Length of Exposure|Length of exposure includes interruptions.|Up to 2 years|Safety Population||Week||Standard Deviation|Mean
794013|NCT00910091|Secondary|Percentage of Participants With Adverse Event (AE)|Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe, Grade 4: Life threatening/disabling and Grade 5: Death|Up to Day 28 follow-up|Safety Population: All randomised subjects who received at least one dose of study medication.||Percentage of subjects|||Number
794014|NCT00910091|Primary|Percentage of Women With Advanced or Recurrent Endometrial Cancer Who Have Neither Progressed Nor Died|Subject continuation in the study and Response Evaluation Criteria in Solid Tumours (RECIST) assessment has been based on investigator assessment and not on central review. The 6 month timepoint is defined as the treatment start date +183 days (26 weeks).|Up to 6 months|Intent-to-treat (ITT) population includes all randomized subjects who received at least one dose of study medication.||Percentage of subjects||90% Confidence Interval|Number
794015|NCT00910273|Secondary|Change From Baseline in Chest Expansion at Weeks 4, 12, 24, 36 and 52|Chest expansion defined as the difference in thoracic circumference during full expiration versus full inspiration, measured in cm at the fourth intercostal space (nipple line) while participant was standing. Measurement taken twice and best of the two measurements (corresponding to the highest value of inspiration and smallest value for expiration), were then averaged. Greater chest circumference indicated improvement in spinal mobility. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection.|Baseline, Weeks 4, 12, 24, 36 and 52 or ET|mITT; n= number of participants evaluable at specific time point; Due to limited number of participants with visits after Week 12 analysis limited to Week 12||cm||Standard Deviation|Mean
794016|NCT00910273|Secondary|Change From Baseline in Occiput-to-Wall Distance at Weeks 4, 12, 24, 36 and 52|While participant stood with back against the wall and during maximal effort to touch head to the wall, the distance between the occiput (back of head) and the wall was measured. The measurement of two attempts was made and best of the two measurements which corresponds to the highest value were reported. Lower scores indicated improvement in spinal mobility. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection.|Baseline, Weeks 4, 12, 24, 36 and 52 or ET|mITT; n= number of participants evaluable at specific time point||cm||Standard Deviation|Mean
794017|NCT00910273|Secondary|Change From Baseline in BASMI-Lateral Flexion at Weeks 4, 12, 24, 36 and 52|Measurement in cm of distance between participant's middle fingertip and the floor after bending sideways, without bending knees or lifting heels, while attempting to keep shoulders in same place (flexion position). Two measurements on the right and 2 on the left were made. The best of the two measurements for each side (corresponding to the highest value), were then averaged. Higher score indicated greater spinal mobility. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection.|Baseline, Weeks 4, 12, 24, 36 and 52 or ET|mITT; n= number of participants evaluable at specific time point||cm||Standard Deviation|Mean
794018|NCT00910273|Secondary|Change From Baseline in BASMI-Tragus to Wall Distance at Weeks 4, 12, 24, 36 and 52|Measurement in cm of distance between the tragus and wall from the right and left side while participant was standing with back against the wall; knees straight; scapulae, buttocks, and heels against the wall; with head in a neutral position. Two measurements on the right and 2 on the left were made. The best of the two measurements for each side (corresponding to the smallest value), were then averaged. Higher score indicated greater spinal mobility. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection.|Baseline, Weeks 4, 12, 24, 36 and 52 or ET|mITT; n= number of participants evaluable at specific time point||cm||Standard Deviation|Mean
794041|NCT00910520|Secondary|Change From Baseline in Volume Voided Per Micturition|The total volume voided was measured over one 24-hour period in the week prior to the Baseline and Week 12 study visit and recorded by the patient in the bladder diary. This was used to calculate volume voided per micturition. A positive number change from baseline indicates an increase in volume voided per micturition (improvement).|Baseline, Week 12|Intent-to-treat population included all randomized patients.||milliliters||Standard Deviation|Mean
794019|NCT00910273|Secondary|Change From Baseline in BASMI-Modified Schober's Test at Weeks 4, 12, 24, 36 and 52|Measurement in cm of distance between marks originally placed while participant was standing erect 10 cm above and 5 cm below the midpoint of a line that joins the posterior superior iliac spines. Distance between marks was re-measured with participant maximally bent forward, knees fully extended, with supine in full flexion. The measurement was carried out two times and best of the two measurements which corresponds to the highest value were reported. Higher score indicated greater spinal mobility. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection.|Baseline, Weeks 4, 12, 24, 36 and 52 or ET|mITT; n= number of participants evaluable at specific time point||cm||Standard Deviation|Mean
794020|NCT00910273|Secondary|Change From Baseline in BASMI-Intermalleolar Distance at Weeks 4, 12, 24, 36 and 52|Measurement in cm of the distance between the medial malleoli when participant was lying supine with knees straight and feet pointed straight up with legs separated as far as possible, 2 attempts were measured. The best of the two measurements which corresponds to the highest value were reported. Higher score indicated greater spinal mobility. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection.|Baseline, Weeks 4, 12, 24, 36 and 52 or ET|mITT; n= number of participants evaluable at specific time point||cm||Standard Deviation|Mean
794021|NCT00910273|Secondary|Change From Baseline in BASMI-Cervical Rotation at Weeks 4, 12, 24, 36 and 52|While in a neutral position, the participant turned the head as far as possible to the right and then to the left. Using a goniometer the degrees of movement were measured. Two measurements on the right and 2 on the left were made. The best of the two measurements for each side (corresponding to the highest value), were then averaged. Higher score indicated greater spinal mobility. Actual rotation ranged from 3.0 to 99.0 degrees. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection.|Baseline, Weeks 4, 12, 24, 36, 52 or ET|mITT; n= number of participants evaluable at specific time point||degrees of movement||Standard Deviation|Mean
794022|NCT00910273|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 4, 12, 24, 36, and 52|BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10. Lower score indicated better spinal mobility. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection.|Baseline, Weeks 4, 12, 24, 36 and 52 or ET|mITT; n=number of participants evaluable at specific time point||Units on a scale||Standard Deviation|Mean
794023|NCT00910273|Secondary|Percentage of Participants With ASAS Partial Remission at Weeks 4, 12, 24, 36, and 52|Partial remission defined as a score of less than 20 units (on a scale of 0-100, where 0 = no disease activity and 100 = high disease activity) in each of the 4 Assessment in Ankylosing Spondylitis (ASAS) domains: participant global assessment of disease activity, pain, function, and inflammation. For scale, 100=high disease activity.|Weeks 4, 12, 24, 36 and 52 or ET|mITT; N=number of participants evaluable; n=number of participants evaluable at specific time point||percentage of participants|||Number
794024|NCT00910273|Secondary|Percentage of Participants With ASAS 5/6 at Weeks 4, 12, 24, 36, and 52|ASAS 5/6 consists of 6 domains: the 4 used in ASAS 20 (participant global assessment of disease activity, pain, function, inflammation measured on a 0-100 scale, where 0 = no disease activity and 100=high disease activity) plus spinal mobility and an acute phase reactant, C Reactive Protein (CRP). Achieving ASAS 5/6 requires a 20% improvement compared to baseline in ≥ 5 domains and no worsening in the remaining domain.|Weeks 4, 12, 24, 36 and 52 or ET|mITT; N=number of participants evaluable; n=number of participants evaluable at specific time point||percentage of participants|||Number
794025|NCT00910273|Secondary|Percentage of Participants With ASAS 70 at Weeks 4, 12, 24, 36, and 52|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 70 = 70% improvement (vs. baseline) and an absolute change ≥ 20 units on a 0-100 mm scale (0 mm = no disease activity, 100 mm = high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|Weeks 4, 12, 24, 36 and 52 or ET|mITT; N=number of participants evaluable; n=number of participants evaluable at specific time point||percentage of participants|||Number
794026|NCT00910273|Secondary|Percentage of Participants With ASAS 50 at Weeks 4, 12, 24, 36, and 52|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 50 = 50% improvement (vs. baseline) and an absolute change ≥ 20 units on a 0-100 mm scale (0 mm = no disease activity, 100 mm = high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|Weeks 4, 12, 24, 36 and 52 or ET|mITT; N=number of participants with evaluable; n=number of participants evaluable at specific time point||percentage of participants|||Number
794027|NCT00910273|Secondary|Percentage of Participants With ASAS 40 at Weeks 4, 12, 24, 36, and 52|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40% improvement from baseline and an absolute change ≥ 20 units on a 0-100 mm scale (0 mm = no disease activity, 100 mm = high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|Weeks 4, 12, 24, 36, and 52 or ET|mITT; N=number of participants evaluable; n=number of participants evaluable at specific time point||percentage of participants|||Number
794028|NCT00910273|Secondary|Percentage of Participants With Assessment in Ankylosing Spondylitis (ASAS) 20 at Weeks 4, 12, 24, 36, and 52|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement from baseline and an absolute change greater than or equal to (≥) 10 units on a 0-100 millimeter (mm) scale (0 mm = no disease activity; 100 mm = high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|Week 4, 12, 24, 36, and 52 or ET|mITT; N=number of participants evaluable; n=number of participants evaluable at specific time point||percentage of participants|||Number
794291|NCT00905567|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 96 hour period|Data from all subjects who completed the study was included in statistical analysis.||ng/mL||Standard Deviation|Mean
794029|NCT00910273|Secondary|Percentage of Participants With BASDAI 50 Percent (%) Improvement at Weeks 4, 12, 24, 36, and 52|BASDAI a validated self assessment tool used to determine disease activity in participants with AS. Utilizing a VAS of 0 (none) to 10 cm (very severe), participant's answered 6 questions measuring discomfort, pain and fatigue. BASDAI 50 response defined as at least a 50% improvement (decrease) from baseline in BASDAI. Baseline score – score at observation divided by Baseline score * 100 = greater than or equal to 50%.|Weeks 4, 12, 24, 36, and 52 or ET|mITT; N=number of participants evaluable; n=number of participants evaluable at specific time point||percentage of participants|||Number
794030|NCT00910273|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 4, 12, 24, 36 and 52|BASDAI a validated self assessment tool to determine disease activity in participant with Ankylosing Spondylitis (AS) using a Visual Analog Scale (VAS) of 0 (none) to 10 (very severe) centimeter (cm). Participant answered 6 questions measuring discomfort, pain and fatigue. Final BASDAI score averages the individual assessments for a final score range of 0-10. Change: Week x observation minus Baseline observation. Higher score indicates greater disability. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection.|Baseline, Weeks 4, 12, 24, 36, and 52 or ET|mITT; n= number of participants evaluable at specific time point||Units on a scale||Standard Deviation|Mean
794031|NCT00910273|Secondary|Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 12, 24, 36, 52|CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection.|Baseline, Weeks 4, 12, 24, 36 and 52 or ET|mITT; N=number of participants evaluable; n= number of participants evaluable at specific time point||mg/liter (mg/L)||Standard Deviation|Mean
794032|NCT00910273|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 4, 12, 24, 36 and 52|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hour (hr). A higher rate is consistent with inflammation. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection.|Baseline, Weeks 4, 12, 24, 36 and 52 or ET|mITT; N=number of participants evaluable; n= number of participants evaluable at specific time point||mm/hr||Standard Deviation|Mean
794033|NCT00910273|Secondary|Change From Baseline in Total Serum Homocysteine at Weeks 4, 12, 24, 36 and 52|Mean serum homocysteine blood concentrations. Lower values of homocysteine indicate improvement in inflammation. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection.|Baseline, Weeks 4, 12, 24, 36 and 52 or ET|mITT; n= number of participants evaluable at specific time point; N=number of participants evaluable||micromole/liter (µmol/L)||Standard Deviation|Mean
794034|NCT00910273|Secondary|Change From Baseline Lipid Parameters at Weeks 4, 12, 24, 36 and 52|Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL) and Triglyceride (TGL) blood concentrations, lower values indicated improvement in cardiovascular risk. Mean High Density Lipoprotein (HDL), higher values indicated improvement in cardiovascular risk. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection.|Baseline, Weeks 4, 12, 24, 36 and 52 or ET|mITT; n=number of participants evaluable at specific time point; N=number of participants evaluable||millimole/Liter (mmol/L)||Standard Deviation|Mean
794035|NCT00910273|Secondary|Change From Baseline in Carotid Intima Media Thickness (IMT) at Weeks 12 and 52|Change in IMT in the distal common carotid arteries (CCA), common bulbs (CB), and internal carotid arteries (ICA) as determined by ultrasound. Higher scores indicate worsening in cardiovascular risk assessment. Change: Week x observation minus Baseline observation.|Baseline, Week 12 and 52 or ET|mITT; n=number of participants evaluable at specific time point; N=number of participants evaluable||mm||Standard Deviation|Mean
794036|NCT00910273|Secondary|Change From Baseline in Flow-Mediated Dilatation at Weeks 4, 24, 36, and 52|BA FMD =(maximum diameter -baseline diameter divided by baseline diameter) * 100%. Ultrasound images of BA at rest were followed by BP cuff inflated to at least 50 mm Hg above participants systolic BP for 5 minutes. Cuff released and reactive hyperaemia was produced. BA was imaged continuously from 30 seconds prior cuff inflation to 2 minutes after cuff deflation. Higher scores indicate improved endothelial function. Change: Week x observation minus Baseline observation.|Baseline, Weeks 4, 24, 36, and 52 or Early Termination (ET)|mITT; n=number of participants evaluable at specific time point||percentage of BA diameter||Standard Deviation|Mean
794037|NCT00910273|Primary|Change From Baseline in Flow-Mediated Dilatation (FMD) at Week 12|Brachial artery (BA) FMD equals (=)(maximum diameter minus[-] baseline diameter divided by baseline diameter) times (*) 100 percent (%). Ultrasound images of BA at rest were followed by blood pressure (BP) cuff inflated to at least 50 millimeters of mercury (mm Hg) above participants systolic BP for 5 minutes. Cuff released and reactive hyperaemia was produced. BA was imaged continuously from 30 seconds prior cuff inflation to 2 minutes after cuff deflation. Higher scores indicate improved endothelial function.|Baseline, Week 12|Modified Intent to Treat Population (mITT): all randomized participants who received at least one dose of test article followed by at least one available evaluation; n=number of participants evaluable at specific time point||percentage of BA diameter||Standard Deviation|Mean
794038|NCT00910299|Secondary|Number of Participants With Composite Endpoint of All-Cause Death or Myocardial Infarction (MI)|The endpoint in this measure is a combination of all-cause death or MI.|Baseline through 6 months|Participants who were randomized.||participants|||Number
794039|NCT00910299|Secondary|Number of Participants With Stent Thrombosis (ST)|Academic Research Consortium (ARC) criteria was used to define ST. Definite ST is angiographic or pathologic confirmation of partial or total thrombotic occlusion within the peri-stent region, and at least one of the following additional criteria: acute ischemic symptoms; ischemic electrocardiogram changes; elevated cardiac biomarkers. Probable ST is any unexplained death within 30 days of stent implantation; any MI, which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of ST and in the absence of any other obvious cause.|Baseline through 6 months|Participants who were randomized.||participants|||Number
794042|NCT00910520|Secondary|Change From Baseline in Number of Daily Micturition Episodes|The number of micturition episodes (the number of times a patient urinates into the toilet) was recorded by the patient in a bladder diary during 3 consecutive days in the week prior to the Baseline and prior to the Week 12 study visit. A negative number change from baseline indicates a reduction in micturition episodes (improvement).|Baseline, Week 12|Intent-to-treat population included all randomized patients.||micturition episodes||Standard Deviation|Mean
794043|NCT00910520|Primary|Change From Baseline in Number of Daily Episodes of Urinary Incontinence|A urinary incontinence episode is defined as an incident of involuntary loss of urine as recorded in a patient bladder diary during the 3 days before the Baseline and Week 12 study visits. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).|Baseline, Week 12|Intent-to-treat population included all randomized patients.||Incontinence episodes||Standard Deviation|Mean
794044|NCT00910624|Secondary|Percentage of Participants With Early Virologic Response (EVR)|EVR was defined as undetectable HCV-RNA at TW 12 of BOC + PEG/RBV. EVR rates were evaluated by the prior interferon response (e.g., log drop from baseline at TW 4 or TW 12) in the previous studies.|From TW 1 to TW 12|"All BOC-Treated Participants: All enrolled participants who received at least 1 dose of BOC. Data for 2 Other participants were included in the calculations for BOC + PEG/RBV: All  (n=164). 4 discontinued during the 4-week PEG/RBV lead-in and did not receive BOC and thus were excluded from analysis."||percentage of participants|||Number
794045|NCT00910624|Primary|Percentage of Participants With Adverse Events (AEs) Leading to Dose Modification (DM) or Discontinuation (DC), Treatment-Related Serious AEs (SAEs), Neutrophil Count <0.75 × 10^9/L, or Hemoglobin (Hgb) <10 g/dL|AE= any untoward medical occurrence in a participant administered a pharmaceutical product/biologic (at any dose), whether or not considered related to the use of that product. Included the onset of new illness and the exacerbation of pre-existing conditions. Clinically significant laboratory abnormalities that required intervention/additional therapy, required a dose modification, or were associated with a clinical manifestation were considered AEs. SAE= any adverse drug or biologic or device experience occurring at any dose resulting in death, was life-threatening, was persistent or caused significant disability/incapacity, required in-patient hospitalization or prolonged hospitalization, or was a congenital anomaly or birth defect.|From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through FW 24 (up to 68 weeks)|All Treated Participants: All enrolled participants who received at least one dose of treatment.||percentage of participants|||Number
794046|NCT00910624|Primary|Percentage of Participants With Sustained Virologic Response at Follow-Up Week 24 (SVR24);|SVR24 was defined as undetectable Hepatitis C Virus ribonucleic acid (HCV-RNA) at Follow-up Week (FW) 24. SVR rates were evaluated by the prior interferon response (e.g., log drop from baseline at TW 4 or TW 12) in the previous studies.|From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through Follow-Up Week (FW) 24 (up to 68 weeks)|"All BOC-Treated Participants: All enrolled participants who received at least 1 dose of BOC. Data for 2 Other participants were included in the calculations for BOC + PEG/RBV: All  (n=164). 4 discontinued during the 4-week PEG/RBV lead-in and did not receive BOC and thus were excluded from analysis."||percentage of participants|||Number
794047|NCT00910663|Primary|AUC0-t|Bioequivalence based on AUC0-t - Area under concentration-time curve from time zero to time of last non-zero concentration|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.||µg*h/mL||Standard Deviation|Mean
794048|NCT00910663|Primary|AUC0-inf|Bioequivalence based on AUC0-inf - Area under concentration-time curve from time zero to infinity (extrapolated)|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.||µg*h/mL||Standard Deviation|Mean
794049|NCT00910663|Primary|Cmax|Bioequivalence based on Cmax - Maximum Drug Concentration|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.||µg/mL||Standard Deviation|Mean
794050|NCT00910689|Secondary|Change in Quality of Life at Month 16|Change in Migraine Specific Quality of Life Questionnaire (MSQL; Martin, et al., 2000: v 2.1) scores relative to OAT run-in. The MSQL is a 14-item self-report measure that assesses the impact of migraine. The total score ranges from 14 to 84 with higher scores reflecting greater impairment.|Change from Month 1 to Month 16|Efficacy analyses were intent-to-treat analyses that included all randomized (N = 232) participants.||Scores on a scale||95% Confidence Interval|Mean
794051|NCT00910689|Secondary|Change in the Number of Migraine Days Per 30 Days at Month 16|Change in the number of migraine days per 30 days at Month 16 relative to the OAT run-in (Month 1). Assessed by participant electronic diary.|Change form Month 1 to Month 16|Efficacy analyses were intent-to-treat analyses that included all randomized (N = 232) participants.||Number of Days||95% Confidence Interval|Mean
794052|NCT00910689|Secondary|Change in Number of Migraine Episodes Per 30 Days at Month 16.|Change in number of migraine episodes (with 24 hours pain free period required between episodes) per 30 days from OAT run-in (Month 1) to Month 16. Assessed by participant daily electronic diary.|Change from Month 1 to Month 16|Efficacy analyses were intent-to-treat analyses that included all randomized (N = 232) participants.||Number of Migraine Episodes||95% Confidence Interval|Mean
794053|NCT00910689|Secondary|Change in Quality of Life at Month 10|Change in Migraine Specific Quality of Life Questionnaire (MSQL; Martin, et al., 2000: v 2.1) scores at Month 10 relative to OAT run-in (Month 1). The MSQL is a 14-item self-report measure that assesses the impact of migraine. The total score ranges from 14 to 84 with higher scores reflecting greater impairment.|Change from Month 1 to Month 10|Efficacy analyses were intent-to-treat analyses that included all randomized (N = 232) participants.||Scores on a scale||95% Confidence Interval|Mean
794054|NCT00910689|Secondary|Change in the Number of Migraine Days Per 30 Days at Month 10|Change in the number of days with migraine per 30 days at Month 10 relative to the OAT Run-in (Month 1). Obtained from daily electronic diary.|Change from Month 1 to Month 10|Efficacy analyses were intent-to-treat analyses that included all randomized (N = 232) participants.||Number of days||95% Confidence Interval|Mean
794055|NCT00910689|Primary|Change in Number of Migraine Episodes Per 30 Days at Month 10.|Change in number of migraine episodes(with 24 hours pain free period required between episodes)per 30 days from OAT run-in (Month 1) to Month 10.Obtained from daily electronic diary.|Change from Month 1 to Month 10|Efficacy analyses were intent-to-treat analyses that included all randomized (N = 232) participants.||Number of Migraine episodes||95% Confidence Interval|Mean
794056|NCT00910715|Secondary|Number of Patients (at 6 Months After Treatment With Doxycycline for 10 or 15 Days for Erythema Migrans) and Number of Control Subjects (Without a History of Lyme Borreliosis) With Nonspecific Symptoms.|"6 months after treatment patients and controls were asked to complete a written questionnaire asking whether they had had any of 14 nonspecific symptoms (fatigue, malaise, arthralgias, headache, myalgias, pain in the spine, paresthesias, dizziness, nausea, insomnia, sleepiness, forgetfulness, concentration difficulties, or irritability) within the preceding week.
For both patients and controls, the severity of each individual symptom was graded by the subject on a 10-cm visual analog scale (10 = most severe)."|6 months after treatment|number of participants with nonspecific symptoms||number of participants|||Number
794057|NCT00910715|Primary|Objective Sequelae and Post-treatment Subjective New or Increased Symptoms (NOIS)in Patients Treated for Erythema Migrans With Doxycycline for 10 or 15 Days.|At each visit patients were examined and asked about the presence of any symptoms that newly developed/had worsened since erythema migrans. If such symptoms had no other medical explanation they were regarded as new or increased symptoms (NOIS). Complete response=absence of any manifestations of Lyme borreliosis, with return to pre-Lyme borreliosis health status. Partial response=presence of NOIS. Failure=presence of objective manifestations of Lyme borreliosis or persistence of B. burgdorferi sensu lato in skin at the site of the previous erythema migrans.|1 year follow-up|Number of participants with complete response to treatment.||number of participants|||Number
794058|NCT00910728|Primary|Inhibition of PSTAT3 (Count)|PSTAT3 inhinition|2hrs and 4 hrs post dose|||# patients with 50% reduction in PSTAT3|||Number
794059|NCT00910728|Primary|Pharamcokinetic Parameters Following Multiple Dosing: Tmax,ss|Multiple dose Tmax,ss (h)|On Days 1 and 28 at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose and at 0, 2, 4 hours post-dose on Days 4 and 10|||h||Full Range|Median
794060|NCT00910728|Primary|Pharamcokinetic Parameters Following Single Dosing: Tmax|Single dose Tmax (h)|0 to 24 hour sampling (Day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose)|||h||Full Range|Median
794061|NCT00910728|Primary|Pharmacokinetic Parameters Following Multiple Dosing: CLss/F|Multiple dose CLss/F (L/h)|On Days 1 and 28 at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 hours post dose and at 0, 2, 4 hours post-dose|"Pharmacokinetic.
Note - no GeoCV(%) was captured in the TFL. Hence the geometric mean was still presented as applicable but with the SD (since only available)."||L/h||Standard Deviation|Geometric Mean
794062|NCT00910728|Primary|Pharmacokinetic Parameters Following Single Dosing: CL/F|Single dose CL/F (L/h)|0 to 24 hour sampling (Day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose)|"Pharmacokinetic.
Note - no GeoCV(%) was captured in the TFL. Hence the geometric mean was still presented as applicable but with the SD (since only available)."||L/h||Standard Deviation|Geometric Mean
794063|NCT00910728|Primary|Pharmacokinetic Parameters Following Single Dosing: Vz/F|Single dose Vz/F (L)|0 to 24 hour sampling (Day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose)|"Pharmacokinetic.
Note - no GeoCV(%) was captured in the TFL. Hence the geometric mean was still presented as applicable but with the SD (since only available).
Due to the nature of the dosing schedule this PK parameter was not reported for the BID (twice daily dosing) groups."||L||Standard Deviation|Geometric Mean
794064|NCT00910728|Primary|Pharmacokinetic Parameters Following Single Dosing: Cmax|Single dose Cmax (ug/L)|0 to 24 hour sampling (Day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose)|"Pharmacokinetic.
Note - no GeoCV(%) was captured in the TFL. Hence the geometric mean was still presented as applicable but with the SD (since only available)."||ug/L||Standard Deviation|Geometric Mean
794065|NCT00910728|Primary|Pharmacokinetic Parameters Following Multiple Dosing: Cmin,ss|Multiple dose Cmin,ss (ug/L)|On Days 1 and 28 at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose and at 0, 2, 4 hours post-dose on Days 4 and 10.|"Pharmacokinetic.
Note - no GeoCV(%) was captured in the TFL. Hence the geometric mean was still presented as applicable but with the SD (since only available)."||ug/L||Standard Deviation|Geometric Mean
794066|NCT00910728|Primary|Pharmacokinetic Parameters Following Multiple Dosing: Cmax,ss|Multiple dose Cmax,ss (ug/L)|On Days 1 and 28 at 0, 0,5, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose, and at 0, 2, 4 hours post dose on Days 4 and 10|"Pharmacokinetic.
Note - no GeoCV(%) was captured in the TFL. Hence the geometric mean was still presented as applicable but with the SD (since only available)."||ug/L||Standard Deviation|Geometric Mean
794067|NCT00910728|Primary|Pharmacokinetic Parameters Following Single Dosing:AUC0-inf|Single dose AUC(0 to infinity) (ug*h/L)|0 to 24 hour sampling (Day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose)|"Pharmacokinetic.
Note - no GeoCV(%) was captured in the TFL. Hence the geometric mean was still presented as applicable but with the SD (since only available).
From the BID (twice a day dosing schedules) we can not derive the PK parameter AUC0_inf following single dosing. With that these do not contribute."||ug*h/L||Standard Deviation|Geometric Mean
794068|NCT00910728|Primary|Pharmacokinetic Parameters Following Single Dosing: AUC0-24|Single dose AUC0-24 (ug*h/L)|0 to 24 hour sampling (Day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose)|"Pharmacokinetic.
Note - no GeoCV(%) was captured in the TFL. Hence the geometric mean was still presented as applicable but with the SD (since only available).
From the BID schedule we can not derive the single dosing AUC0_24 and hence this is not presented/calculated."||ug*h/L||Standard Deviation|Geometric Mean
794069|NCT00910728|Primary|Pharmacokinetic Parameters Following Single Dosing: AUC0-12|Single dose AUC0-12 (ug*h/L)|0 to 12 hour sampling (Day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours post dose)|"Pharmacokinetic.
Note - no GeoCV(%) was captured in the TFL. Hence the geometric mean was still presented as applicable but with the SD (since only available)."||ug*h/L||Standard Deviation|Geometric Mean
794070|NCT00910845|Secondary|Change From Baseline in Volume Voided Per Micturition|The total volume voided was measured over one 24-hour period in the week prior to the Baseline and Week 12 study visit and recorded by the patient in the bladder diary. This was used to calculate volume voided per micturition. A positive number change from baseline indicates an increase in volume voided per micturition (improvement).|Baseline, Week 12|Intent-to-treat population included all randomized patients.||milliliters||Standard Deviation|Mean
794071|NCT00910845|Secondary|Change From Baseline in Number of Daily Micturition Episodes|The number of micturition episodes (the number of times a patient urinates into the toilet) was recorded by the patient in a bladder diary during 3 consecutive days in the week prior to the Baseline and prior to the Week 12 study visit. A negative number change from baseline indicates a reduction in micturition episodes (improvement).|Baseline, Week 12|Intent-to-treat population included all randomized patients.||micturition episodes||Standard Deviation|Mean
794072|NCT00910845|Primary|Change From Baseline in Number of Daily Episodes of Urinary Incontinence|A urinary incontinence episode is defined as an incident of involuntary loss of urine as recorded in a patient bladder diary during the 3 days before the Baseline and Week 12 study visits. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).|Baseline, Week 12|Intent-to-treat population included all randomized patients.||Incontinence episodes||Standard Deviation|Mean
794073|NCT00910858|Secondary|Marrow-infiltrating Lymphocyte (MIL) Number and Cytolytic Activity|Due to the low number of bone marrow samples collected this analysis was not performed.|Pre-Study and Week 16|Unable to obtain sufficient bone marrow samples to perform analyses|||||
794074|NCT00910858|Primary|Monotherapy Phase: Area-under-the Concentration-time Curve (AUC0-5) for Lenalidomide|Area under the plasma concentration-time curve from Time 0 to 5 hours postdose for lenalidomide (its R- and S- enantiomers and the enantiomers combined) after multiple dosing for 14 days, calculated using the log-linear trapezoidal method.|On Day 14 blood samples were taken at predose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, and 5 hours postdose.|Monotherapy Phase pharmacokinetic population||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
794075|NCT00910858|Secondary|Change From Baseline in Bone Marrow Cellularity and Correlation With Grade 4 Myelosuppression|Bone marrow cellularity is the volume ratio of hematopoietic stem cells and adipocytes (fat cells). Due to the small number of bone marrow samples, this analysis was not performed.|Baseline and Week 16|Unable to obtain sufficient bone marrow samples to perform analyses.|||||
794076|NCT00910858|Secondary|Percentage of Participants Overall With Erythroid Response by Baseline Erythropoietin Level|To evaluate the predictive value of pretreatment serum erythropoietin (EPO) concentration for erythroid response to lenalidomide, the percentage of erythroid responders versus non-responders were stratified by Baseline EPO levels (≤ 500 mIU/mL versus > 500 mIU/mL). Response includes participants with either a major or minor response.|Assessed every 28 days until study discontinuation (up to 1218 days)|Safety population.||percentage of participants|||Number
794077|NCT00910858|Secondary|Percentage of Participants With a Erythroid Response Across All Phases|Erythroid response was categorized as either a major response or a minor response. A major response was defined as red blood cell (RBC) transfusion independence during any consecutive 56-day period and an increase in hemoglobin of at least 1.5 g/dL. A minor response was defined as a ≥ 50% or ≥ 4 unit decrease in RBC transfusions from pretreatment requirements (the number of RBC transfusions required over an 8-week period before the start of study drug treatment).|Assessed every 28 days until study discontinuation (up to 1218 days).|Safety population, which comprised all enrolled patients who took at least 1 dose of study drug during the Monotherapy Phase or the Combined Treatment Phase.||percentage of participants|||Number
794078|NCT00910858|Secondary|Time to Grade 4 Neutropenia or Thrombocytopenia|Time to the first event of grade 4 neutropenia or thrombocytopenia, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0, was calculated as date of first event - date of first dose + 1.|From the date of first dose until 30 days after the last dose (up to 1218 days)|Safety population, which comprised all enrolled patients who took at least 1 dose of study drug during the Monotherapy Phase or the Combined Treatment Phase.||days||Full Range|Median
794079|NCT00910858|Secondary|Monotherapy Phase: Percent of Lenalidomide Excreted Over 5 Hours Post Day 14 Dose|"Percent of the administered lenalidomide dose excreted unchanged in urine over 5 hours postdose after multiple dosing for 14 days, calculated as:
(amount excreted unchanged in urine over the first 5 hours postdose / Dose) * 100.
The dose was 10 mg for total lenalidomide and 5 mg for the enantiomers."|On Day 14, at predose and over the interval of 0-5 hours postdose.|Monotherapy Phase Pharmacokinetic Population.||percent of administered dose||Geometric Coefficient of Variation|Geometric Mean
794080|NCT00910858|Secondary|PK Phase: Percent of Administered Lenalidomide Excreted Over 24 Hours After a Single, Oral Dose|"Percent of the administered dose of lenalidomide excreted unchanged in urine over 24 hours postdose after a single dose on Day -7, calculated as:
(amount excreted unchanged in urine over 24 hours postdose / Dose) * 100.
The dose was 10 mg for total lenalidomide and 5 mg for the enantiomers."|On Day -7 at predose and over the intervals of 0-5, 5-8, 8-12, and 12-24 hours postdose.|PK Phase participants for whom data was available.||percent of administered dose||Geometric Coefficient of Variation|Geometric Mean
794081|NCT00910858|Secondary|PK Phase: Terminal Half-life (t1/2)|The apparent terminal half-life is the time required for plasma concentration to decrease by 50% after pseudo-equilibrium of distribution has been reached, and calculated as the natural logarithm of 2 (0.693) / Apparent terminal rate constant (λz).|On Day -7 blood samples were taken at predose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, and 24 hours postdose.|Pharmacokinetic Phase participants.||hours||Geometric Coefficient of Variation|Geometric Mean
794082|NCT00910858|Secondary|Monotherapy Phase: Maximum Plasma Concentration of Lenalidomide (Cmax)|The Maximum observed plasma concentration (Cmax) of lenalidomide (its R- and S- enantiomers and the enantiomers combined) after multiple dosing for 14 days.|On Day 14 blood samples were taken at predose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, and 5 hours postdose.|Monotherapy Phase pharmacokinetic population.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
794083|NCT00910858|Secondary|PK Phase: Maximum Plasma Concentration of Lenalidomide (Cmax)|The maximum observed plasma concentration (Cmax) of lenalidomide (its R- and S- enantiomers and the enantiomers combined) after a single dose on day -7.|On Day -7 blood samples were taken at predose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, and 24 hours postdose.|All Pharmacokinetic Phase participants||ng/mL||Geometric Coefficient of Variation|Geometric Mean
794084|NCT00910858|Primary|PK Phase: Area-under-the Concentration-time Curve (AUC0-24) for Lenalidomide|Area under the plasma concentration-time curve from Time 0 to 24 hours post-dose for lenalidomide after a single dose, calculated using the log-linear trapezoidal method.|On Day -7 blood samples were taken at predose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, and 24 hours post-dose.|All Pharmacokinetic Phase participants.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
794113|NCT00911144|Secondary|Number of Subjects Reporting Unsolicited Adverse Events|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study. Also any “solicited” symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.|Within 31 days (Days 0 to 30) after booster vaccination|||subjects|||Number
794085|NCT00910871|Secondary|The Percentage of Participants With Sputum Culture Conversion|The table below shows the percentage of participants who were responders to treatment. Sputum culture conversion is defined as 2 consecutive sputum cultures negative for multi-drug resistant tuberculosis (MDR-TB) taken at least 25 days apart. Participants who discontinued or died during the trial were considered non-responders.|Week 120|The modified intent-to-treat (mITT) population used for all efficacy analyses included all randomized participants who received at least 1 dose of TMC207 excluding participants with drug-susceptible tuberculosis (DS-TB) or participants that were not evaluable for efficacy.||Percentage of Participants|||Number
794086|NCT00910871|Primary|The Median Time to Sputum Culture Conversion|The table below shows the median time in days to culture conversion for the modified intent-to-treat (mITT) population up to Week 24. Sputum culture conversion is defined as 2 consecutive sputum cultures negative for multi-drug resistant tuberculosis (MDR-TB) taken at least 25 days apart. Participants who discontinued during the 24-week period were considered non-responders (based on Mycobacteria Growth Indicator Tube [MGIT]).|Up to Week 24|The modified intent-to-treat (mITT) population used for all efficacy analyses included all randomized participants who received at least 1 dose of TMC207 excluding participants with drug-susceptible tuberculosis (DS-TB) or participants that were not evaluable for efficacy.||Days||95% Confidence Interval|Median
794087|NCT00910910|Secondary|Number of Participants With Subsequent Anti-cancer Therapies Received Post Treatment|Subsequent anti-cancer therapies administered to participants following the discontinuation of study drug (either Lenalidomide or Chlorambucil)|Up to data cut-off of 31 March 2014; up to approximately 53 months|The safety population was defined as all randomized participants who received at least 1 dose of the study treatment (either lenalidomide or chlorambucil).||participants|||Number
794088|NCT00910910|Secondary|Time to Response|Time to response was calculated as the time from randomization to the first nPR, PR, CRi or CR based on IWCLL guidelines|Up to data cut-off of 18 Feb 2013; up to approximately 39 months|Intent to treat participants with an objective response as of 18 February 2013||weeks||Full Range|Median
794089|NCT00910910|Secondary|Kaplan-Meier Estimate for Duration of Response|Duration of response was defined as the time from first nPR, PR, CRi, or CR to PD. Duration of response was censored at the last date that the patient was known to be progression-free for: 1) patients who had not progressed at the time of analysis; 2) patients who had withdrawn consent or were lost to follow-up prior to documentation of progression|Up to data cut-off of 18 Feb 2013; up to approximately 39 months|Intent to Treat population with an objective response as of 18 February 2013||weeks||95% Confidence Interval|Median
794090|NCT00910910|Secondary|Percentage of Participants With Overall Response Based on IWCLL Guidelines With a Later Cut-off of 31 March 2014|"A best overall response rate is a CR, CRi, nPR or PR and is defined as:
Complete Remission (CR):
No lymphadenopathy
No hepatomegaly or splenomegaly
Absence of constitutional symptoms
Polymorphonuclear leukocytes ≥ 1500/ul
No circulating clonal B-lymphocytes
Platelets > 100,000/ul
Hemoglobin > 11.0 g/dl
Normocellular <30% lymphocytes, no B-lymphoid nodules;
Incomplete Clinical Response (CRi):
• CR without bone marrow biopsy confirmation.
Nodular Partial Response:
• CR with the presence of residual clonal nodules.
Partial Response requires:
≥ 50% decrease in peripheral blood lymphocyte count
≥ 50% reduction in lymphadenopathy
≥ 50% reduction in size of liver and/or spleen
1 or more of the following:
Polymorphonuclear leukocytes ≥ 1500/ul
Platelets >100,000/ul"|Up to data cut-off of 31 March 2014; approximately 53 months|The Intent-to-Treat (ITT) population was defined as all participants who were randomized, independent of whether they received study treatment or not||percentage of participants with response|||Number
794091|NCT00910910|Secondary|Percentage of Participants With the Best Overall Response Based on the International Workshop on Chronic Lymphocytic Leukemia Guidelines (IWCLL) Guidelines|"A best overall response rate is a CR, CRi, nPR or PR and is defined as:
Complete Remission (CR):
No lymphadenopathy
No hepatomegaly or splenomegaly
Absence of constitutional symptoms
Polymorphonuclear leukocytes ≥ 1500/ul
No circulating clonal B-lymphocytes
Platelets > 100,000/ul
Hemoglobin > 11.0 g/dl
Normocellular <30% lymphocytes, no B-lymphoid nodules;
Incomplete Clinical Response (CRi):
• CR without bone marrow biopsy confirmation.
Nodular Partial Response (nPR):
• CR with the presence of residual clonal nodules.
Partial Response (PR) requires:
≥ 50% decrease in peripheral blood lymphocyte count
≥ 50% reduction in lymphadenopathy
≥ 50% reduction in size of liver and/or spleen
1 or more of the following:
Polymorphonuclear leukocytes ≥ 1500/ul
Platelets >100,000/ul"|Up to data cut-off of 18 Feb 2013; approximately 39 months|This is a smaller population used in this analysis (earlier cut-off date) prior to the last participant enrolled in the study. The Intent-to-Treat (ITT) population was defined as all participants who were randomized, independent of whether they received study treatment or not.||percentage of participants|||Number
794092|NCT00910910|Primary|Kaplan-Meier Estimate of Progression Free Survival (PFS)|Progression-free survival was defined as the time from randomization to the first documented progression confirmed per investigator’s assessment or death due to any cause on study, whichever occurred first. The progression date was assigned to the earliest time when any progression was observed without prior missing assessments. If withdrawal of consent or lost to follow-up occurred before documented progression or death, then these observations were censored at the date when the last complete tumor assessments determined a lack of progression|Data cut-off of 18 Feb 2013; up to approximately 39 months|This is a smaller population used in this analysis (earlier cut-off date) prior to the last participant enrolled in the study. The Intent-to-Treat (ITT) population was defined as all participants who were randomized, independent of whether they received study treatment or not.||months||95% Confidence Interval|Median
794093|NCT00910910|Secondary|Euro Quality of Life Five Dimension (EQ-5D) Questionnaire|The standardized extended version of EQ-5D was designed for the collection of health state values using a visual analogue scale (VAS) rating scale - a vertical 20 cm visual analogue scale with the end points labeled best imaginable health state at the top and worst imaginable health state at the bottom having numeric values of 100 and 0 respectively. The participant is asked to indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement in each of the 5 dimensions.|Day 1 and once every 8 weeks|No data were collected for the EQ-5D QOL assessment.EQ-5D analysis was not conducted due to the discontinuation of the Lenalidomide arm|||||
794237|NCT00912028|Primary|Corneal Staining|Subject distribution according to corneal staining with fluorescein scale in each eye during the 4-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.|4 weeks|Analysis is on those subjects who were enrolled, randomized to a study arm, and completed the study.||eyes|eyes||Number
794094|NCT00910910|Secondary|Functional Assessment of Cancer Therapy-General to Create the FACT-Leukemia (FACT-Leu) Quality of Life Instrument|The FACT-Leu scale is a valid, reliable, and efficient measure of leukemia-specific health-related quality of life for acute and chronic disease. The FACT-Leu is described as including 27 items that assess 17 physical symptoms (fevers, bleeding, general pain, stomach pain, chills, night sweats, bruising, lymph node swelling, weakness, tiredness, weight loss, appetite, shortness of breath, functional ability, diarrhea, concentration, and mouth sores) and 10 emotional/social concerns (frustration with activity limitation, discouraged by illness, future planning, uncertainty, worry about illness, emotional lability, isolation, infertility concern, family worry, and worry about infections).|Day 1 and once every 8 weeks|No data were collected for the FACT-Leu QOL assessment. Analysis not conducted due to the discontinuation of the Lenalidomide arm|||||
794095|NCT00910910|Secondary|Kaplan Meier Estimate of Overall Survival for a Later Cut-off of 31 March 2014|Overall Survival is defined as the time between randomization and death from any cause.|Up to data cut off of 31 March 2014; up to approximately 53 months; median follow-up was 18.8 months|The Intent-to-Treat (ITT) population was defined as all participants who were randomized, independent of whether they received study treatment or not.||Months||95% Confidence Interval|Median
794096|NCT00910910|Secondary|Kaplan Meier Estimate for Overall Survival|Overall Survival is defined as the time between randomization and death from any cause..|Up to data cut off of 18 Feb 2013; up to approximately 39 months;|The Intent-to-Treat (ITT) population was defined as all participants who were randomized, independent of whether they received study treatment or not as of 18 February 2013.||Months||95% Confidence Interval|Median
794097|NCT00910910|Primary|Kaplan-Meier Estimate of Progression Free Survival (PFS) With a Later Cut-off of 31 March 2014|Progression-free survival was defined as the time from randomization to the first documented progression confirmed per investigator’s assessment or death due to any cause on study, whichever occurred first. Progressive disease included lymphadenopathy, an appearance of any new lesion such as enlarged lymph nodes (> 1.5 cm), splenomegaly, hepatomegaly or other organ infiltrates, an increase by 50% or more in greatest determined diameter of any previous site or an increase by 50% or more in the sum of the product of diameters of multiple nodes. The progression date was assigned to the earliest time when any progression was observed without prior missing assessments. If withdrawal of consent or lost to follow-up occurred before documented progression or death, then these observations were censored at the date when the last complete tumor assessments determined a lack of progression.|Data cut-off of 31 March 2014; up to approximately 53 months|The Intent-to-Treat (ITT) population was defined as all participants who were randomized, independent of whether they received study treatment or not.||months||95% Confidence Interval|Median
794098|NCT00910910|Secondary|Time to Response for a Later Cut-off of 31 March 2014|Time to response was calculated as the time from randomization to the first nPR, PR, CRi or CR based on IWCLL guidelines|Up to data cut-off of 31 March 2014; up to approximately 53 months|Intent to Treat participants with an objective response||weeks||Full Range|Median
794099|NCT00910910|Secondary|Kaplan-Meier Estimate for Duration of Response With a Later Cut-off of 31 March 2014|Duration of response was defined as the time from first nPR, PR, CRi, or CR to PD. Duration of response was censored at the last date that the patient was known to be progression-free for: 1) patients who had not progressed at the time of analysis; 2) patients who had withdrawn consent or were lost to follow-up prior to documentation of progression|Up to data cut-off of 31 March 2014; up to approximately 53 months|Intent to Treat participants with an objective response||weeks||95% Confidence Interval|Median
794100|NCT00910910|Secondary|Number of Participants With Adverse Events (AEs) With a Later Cut-off of 31 March 2014|AEs = any noxious, unintended, or untoward medical occurrence that may appear or worsen during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, regardless of cause. Serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs were graded based upon the participants symptoms according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0); AEs were evaluated for severity according to the following scale: Grade 1 = Mild - transient or mild discomfort; no medical intervention required; Grade 2 = Moderate - mild to moderate limitation in activity; Grade 3 = Severe; Grade 4 = Life threatening; Grade 5 = Death|From randomization to the data cut-off of 31 March 2014; Up to 53 months; maximum duration of exposure for Lenalidomide was 1140 days and 406 days for Chlorambucil|The safety population was defined as all randomized participants who received at least 1 dose of the study treatment (either lenalidomide or chlorambucil).||participants|||Number
794101|NCT00910910|Secondary|Number of Participants With Adverse Events (AEs)|AEs = any noxious, unintended, or untoward medical occurrence that may appear or worsen during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, regardless of cause. Serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs were graded based upon the participants symptoms according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0); AEs were evaluated for severity according to the following scale: Grade 1 = Mild - transient or mild discomfort; no medical intervention required; Grade 2 = Moderate - mild to moderate limitation in activity; Grade 3 = Severe; Grade 4 = Life threatening; Grade 5 = Death|From randomization up to data cut-off of 18 Feb 2013; Up to approximately 39 months; maximum duration of exposure for Lenalidomide was 1086 days and 406 days for Chlorambucil|This is a smaller population used in this analysis (earlier cut-off date) prior to the last participant enrolled in the study. The safety population was defined as all randomized participants who received at least 1 dose of the study treatment (either lenalidomide or chlorambucil) as of the data cut off date of 18 Feb 2013||participants|||Number
794114|NCT00911144|Secondary|Number of Subjects Reporting Solicited Symptoms|Solicited local symptoms assessed include pain, redness and swelling at the injection site. Solicited general symptoms assessed include drowsiness, fever (equal to or above 37.5 degrees Celsius), irritability and loss of appetite.|Within 4 days (Days 0 to 3) after booster vaccination|Analysis was performed on the Total vaccinated cohort on the subjects with available data.||subjects|||Number
794102|NCT00910988|Primary|Adipose Tissue Insulin Sensitivity|To evaluate, using a within-subject placebo-controlled comparison, the acute effects of olanzapine or ziprasidone administration on insulin sensitivity in antipsychotic-naïve healthy young men, measured as free fatty acid release (glycerol rate of appearance [Ra]).|approximately 3 hours|The analysis was per protocol and involved subjects who completed both a clamp that involved an injection of either olanzapine or ziprasidone, and a clamp that involved a placebo injection. Nine subjects did not complete a second clamp as they were lost to follow-up. This resulted in the analysis of 37 participants.||% change from basal to insulin phase||Standard Deviation|Mean
794103|NCT00910988|Primary|Peripheral Insulin Sensitivity|To evaluate, using a within-subject placebo-controlled comparison, the acute effects of olanzapine or ziprasidone administration on insulin sensitivity in antipsychotic-naïve healthy young men, measured as primarily muscle glucose utilization (glucose rate of disappearance [Rd]).|approximately 3 hours|The analysis was per protocol and involved subjects who completed both a clamp that involved an injection of either olanzapine or ziprasidone, and a clamp that involved a placebo injection. Nine subjects did not complete a second clamp as they were lost to follow-up. This resulted in the analysis of 37 participants.||% change from basal to insulin phase||Standard Deviation|Mean
794104|NCT00910988|Primary|Hepatic Insulin Sensitivity|To evaluate, using a within-subject placebo-controlled comparison, the acute effects of olanzapine or ziprasidone administration on insulin sensitivity in antipsychotic-naïve healthy young men, measured as hepatic glucose production (glucose rate of appearance [Ra]).|approximately 3 hours|The analysis was per protocol and involved subjects who completed both a clamp that involved an injection of either olanzapine or ziprasidone, and a clamp that involved a placebo injection. Nine subjects did not complete a second clamp as they were lost to follow-up. This resulted in the analysis of 37 participants.||% change from basal to insulin phase||Standard Deviation|Mean
794105|NCT00910988|Primary|Whole Body Insulin Sensitivity|To evaluate, using a within-subject placebo-controlled comparison, the acute effects of olanzapine or ziprasidone administration on insulin sensitivity in antipsychotic-naïve healthy young men, measured as whole-body dextrose infusion rates (mg/kg/min).|approximately 3 hours|The analysis was per protocol and involved subjects who completed both a clamp that involved an injection of either olanzapine or ziprasidone, and a clamp that involved a placebo injection. Nine subjects did not complete a second clamp as they were lost to follow-up. This resulted in the analysis of 37 participants.||mg/kg/min||Standard Deviation|Mean
794106|NCT00911144|Secondary|Concentration of Antibodies Against Polyribosyl-ribitol-phosphate (PRP)|Concentrations of antibodies are presented as geometric mean concentrations expressed as microgram per milliliter.|One month after booster vaccination (Month 1)|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data were available for antibodies against at least one study vaccine antigen after booster vaccination.||microgram per milliliter||95% Confidence Interval|Geometric Mean
794107|NCT00911144|Secondary|Concentration of Antibodies Against Protein D (PD)|Concentrations of antibodies are presented as geometric mean concentrations expressed as Enzyme-Linked Immuno-Sorbent Assay (ELISA) units per milliliter.|One month after booster vaccination (Month 1)|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data were available for antibodies against at least one study vaccine antigen after booster vaccination.||ELISA units per milliliter||95% Confidence Interval|Geometric Mean
794108|NCT00911144|Secondary|Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A|Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results are presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions.|One month after booster vaccination (Month 1)|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data were available for antibodies against at least one study vaccine antigen after booster vaccination.||titer||95% Confidence Interval|Geometric Mean
794109|NCT00911144|Secondary|Concentration of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A|Concentrations of antibodies are measured by 22F-inhibition ELISA and are presented as geometric mean concentrations expressed as microgram per milliliter.|One month after booster vaccination (Month 1)|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data were available for antibodies against at least one study vaccine antigen after booster vaccination.||microgram per milliliter||95% Confidence Interval|Geometric Mean
794110|NCT00911144|Secondary|Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes|"Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results are presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions.
Vaccine pneumococcal serotypes included serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F."|One month after booster vaccination (Month 1)|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data were available for antibodies against at least one study vaccine antigen after booster vaccination.||titer||95% Confidence Interval|Geometric Mean
794111|NCT00911144|Secondary|Concentration of Antibodies Against Vaccine Pneumococcal Serotypes|"Concentrations of antibodies are measured by 22F-inhibition enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations expressed as microgram per milliliter.
Vaccine pneumococcal serotypes included serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F."|One month after booster vaccination (Month 1)|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data were available for antibodies against at least one study vaccine antigen after booster vaccination.||microgram per milliliter||95% Confidence Interval|Geometric Mean
794112|NCT00911144|Secondary|Number of Subjects Reporting Serious Adverse Events|Serious adverse events are medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|After booster vaccination up to study end (Month 0 to Month 1)|||subjects|||Number
794115|NCT00911144|Primary|Number of Subjects Reporting Grade 3 Adverse Events|Grade 3 adverse events are severe symptoms that prevent normal, everyday activities.|Within 31 days (Day 0 - Day 30) after booster vaccination.|Analysis was performed on the Total vaccinated cohort on the subjects with available data.||subjects|||Number
794116|NCT00911157|Secondary|Percentage of Participants With a Bleeding Event|Bleeding events (major bleeding [clinically overt bleeding with fatality, location in a critical organ, a fall in hemoglobin >=2 grams (g)/deciliter (dL), or a transfusion >=2 units]; minor bleeding [clinically overt bleeding and not adjudicated as major bleeding], and no bleeding) were adjudicated blindly by the Central Independent Adjudication Committee of Safety (CIACS).|Initial treatment period (from the first dose of FPX/UFH to N days after the last dose of FPX/UFH; specified based on creatinine clearance [CLcr]; N=3, CLcr >=50 mL/min; N=4, 30 =< CLcr < 50 mL/min; N=9, CLcr < 30 mL/min).|Safety Population: all participants who received at least one dose of medication (FPX or UFH).||percentage of participants|||Number
794117|NCT00911157|Secondary|Total Perfusion Score at Baseline and Mean Change From Baseline at Day 5-10|Change from baseline was calculated as the score on the day medication was finished/discontinued (anywhere from Day 5 to Day 10) minus the baseline score. The perfusion score (0: no perfusion; 0.25, 0.5, 0.75, 1: normal) in each of the six lobes of the lung was adjudicated blindly by the CIACE. Total perfusion score (r) was calculated as: r = (0.25 x right lower lobe) + (0.12 x right middle lobe) + (0.18 x right upper lobe) + (0.20 x left lower lobe) + (0.12 x lingula) + (0.13 x left upper lobe).|Baseline, single day between Day 5 and Day 10 (the day when the medication [FPX or UFH] was finished /discontinued) (±1 day)|FAS||points on a scale||Standard Deviation|Mean
794118|NCT00911157|Secondary|Percentage of Participants With Perfusion Lung Scan Results Scored as Improved, no Change, or Worse Compared to Baseline|"Classifications of Improved, No change, or Worse were adjudicated blindly by the CIACE."|Baseline, single day between Day 5 and Day 10 (the day when the medication [FPX or UFH] was finished /discontinued) (±1 day)|FAS||percentage of participants|||Number
794119|NCT00911157|Secondary|Percentage of Participants With Recurrent or New Symptomatic/Asymptomatic VTE (by Type)|VTE (pulmonary thromboembolism [PE] and/or deep vein thrombosis [DVT]) was adjudicated blindly by the CIACE.|From Day 1 to Day 90 (±7 days)|FAS||percentage of participants|||Number
794120|NCT00911157|Primary|Percentage of Participants With Recurrent or New Symptomatic Venous Thromboembolism (VTE)|VTE (pulmonary thromboembolism [PE] and/or deep vein thrombosis [DVT]) was adjudicated blindly by the Central Independent Adjudication Committee of Efficacy (CIACE).|From Day 1 to Day 90 (±7 days)|Full Analysis Set (FAS): all participants receiving at least one dose of medication (FPX or UFH) who had efficacy data and had a confirmed diagnosis of acute symptomatic deep vein thrombosis (DVT)||percentage of participants|||Number
794121|NCT00911170|Secondary|Number of Participants With Adverse Events (AEs)|A serious adverse event (SAE) is defined as an adverse event that - is fatal; - is life threatening (places the participant at immediate risk of death); - requires inpatient hospitalization or prolongation of existing hospitalization; - results in persistent or significant disability/incapacity; - is a congenital anomaly/birth defect; - other significant medical hazard. AEs were assessed for severity according to National Cancer Institute, Common Terminology Criteria for Adverse Events, Version 3.0, based on this general guideline: Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE; Grade 5 = Death related to AE.|Approximately 8 weeks (4 treatment cycles)|Safety analysis set, defined as all participants in the Primary Analysis Set who received at least one dose of investigational product (IP; placebo or pegfilgrastim). One participant was randomized to the placebo arm but actually received pegfilgrastim and is included in the pegfilgrastim arm for the safety analyses.||participants|||Number
794122|NCT00911170|Secondary|Percentage of Participants With Grade 4 Neutropenia Across the First 4 Cycles of Chemotherapy|Grade 4 severe neutropenia is defined as neutropenia with absolute neutrophil count (ANC) <0.5 x 10^9/L.|Approximately 2 months duration (Daily for 4 cycles of treatment; 2 weeks per cycle)|Primary analysis set||percentage of participants||95% Confidence Interval|Number
794123|NCT00911170|Secondary|Percentage of Participants With Grade 3/4 Neutropenia Across the First 4 Cycles of Chemotherapy|Grade 3/4 severe neutropenia is defined as neutropenia with absolute neutrophil count (ANC) <1.0 x 10^9/L.|Approximately 2 months duration (Daily for 4 cycles of treatment; 2 weeks per cycle)|Primary analysis set||percentage of participants||95% Confidence Interval|Number
794124|NCT00911170|Secondary|Percentage of Participants With Grade 4 Febrile Neutropenia Across the First 4 Cycles of Chemotherapy|"Grade 4 febrile neutropenia (FN) is defined as:
A temperature ≥ 38.0ºC (≥ 100.4ºF) and absolute neutrophil count (ANC) < 0.5 × 10^9/L, where ANC is measured the same day or within +/- 1 calendar day of a temperature ≥ 38.0ºC (≥ 100.4ºF), or
An ANC <0.5 × 10^9/L in combination with:
Documented sepsis or infection, OR
Neutropenia-related hospitalization where ANC is measured the same day or within +/- 1 calendar day."|Approximately 2 months duration (Daily for 4 cycles of treatment; 2 weeks per cycle)|Primary analysis set||percentage of participants||95% Confidence Interval|Number
794125|NCT00911170|Secondary|Percentage of Participants With an Objective Response|The percentage of participants with a complete response (CR) or partial response (PR) defined by the RECIST v1.1 criteria at any time during the study. Response was be determined by the investigator’s assessment of radiographic scans. CR: Disappearance of all non-nodal target lesions and the disappearance of all non-nodal non-target lesions, and no new lesions. All nodal lesions must have reduction of short axis to < 10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters and no new lesions and/or unequivocal progression of existing non-target lesions, or, the disappearance of all non-nodal target lesions with persistence of one or more non-target lesion(s).|From randomization to the data cut-off date of 8 June 2012. Median time on study was 11.6 months and the maximum was 27.6 months.|Primary analysis set participants with measurable disease at Baseline.||percentage of participants||95% Confidence Interval|Number
794126|NCT00911170|Secondary|Time to Progression|Time from randomization to date of radiological disease progression calculated using the Kaplan-Meier method. Participants without progression were censored on the date of their last radiographic tumor assessment. Disease progression based on the investigator’s assessment of scans using the RECIST v1.1. Clinical progression without radiological assessment was not considered a disease progression. Progression defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|From randomization to the data cut-off date of 8 June 2012. Median time on study was 11.6 months and the maximum was 27.6 months.|Primary analysis set||months||95% Confidence Interval|Median
794152|NCT00911495|Secondary|Volume of the Central Compartment||48 hours|||mL/kg||Standard Deviation|Mean
794127|NCT00911170|Secondary|Progression Free Survival|Time from randomization to date of radiological disease progression or death from any cause, whichever event occurs first, calculated using the Kaplan-Meier method. Participants without either event by the analysis data cutoff date were censored on the date of their last evaluable disease assessment. Disease progression based on the investigator’s assessment of radiographic scans using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Clinical progression without radiological assessment was not be considered a disease progression in this analysis. Progression defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|From randomization to the data cut-off date of 8 June 2012. Median time on study was 11.6 months and the maximum was 27.6 months.|Primary analysis set||months||95% Confidence Interval|Median
794128|NCT00911170|Secondary|Overall Survival|Median time from randomization to date of death caclulated using the Kaplan-Meier method. Participants were censored on the date of last contact (i.e., the date the participant was last known to be alive) if they were not known to have died.|From randomization to the data cut-off date of 8 June 2012. Median time on study was 11.6 months and the maximum was 27.6 months.|Primary analysis set||months||95% Confidence Interval|Median
794129|NCT00911170|Primary|Percentage of Participants With Grade 3/4 Febrile Neutropenia Across the First 4 Cycles of Chemotherapy|Grade 3/4 febrile neutropenia (FN) is defined as: • A temperature ≥ 38.0°C (≥ 100.4°F) and absolute neutrophil count (ANC) < 1.0 × 10^9/L, where ANC was measured the same day or within ± 1 calendar day of a temperature ≥ 38.0°C (≥ 100.4°F), or • An ANC < 1.0 × 10^9/L in combination with: – documented sepsis or infection, OR – neutropenia-related hospitalization where ANC was measured the same day or within ± 1 calendar day. Participants monitored their oral temperatures and maintained diaries to record their temperature twice per day: once in the morning and once in the evening, as well as whenever they suspect they had fever throughout the first 4 cycles of chemotherapy treatment.|Approximately 2 months duration (Daily for 4 cycles of treatment; 2 weeks per cycle)|The primary analysis set which included all participants with a signed informed consent, and who were randomized and received at least 1 dose of protocol-specified study treatment (chemotherapy, bevacizumab, or investigational product).||percentage of participants||95% Confidence Interval|Number
794130|NCT00911274|Primary|AUC0-t - Area Under Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration|Bioequivalence based on AUC0-t|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.||µg*hr/mL||Standard Deviation|Mean
794131|NCT00911274|Primary|AUC0-inf - Area Under Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.||µg*hr/mL||Standard Deviation|Mean
794132|NCT00911274|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.||µg/mL||Standard Deviation|Mean
794133|NCT00911300|Secondary|Number of Participants Who Were Re-hospitalized|Hospitalization signifies that the participant has been detained (usually involving at least an overnight stay) at the hospital or emergency ward for observation and/or treatment that would not have been appropriate in the physician’s office or out-patient setting. Re-hospitalization refers to an event of hospitalization after discharge for the initial hospitilization for the cardioversion.|Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants; and from Baseline until the follow-up visit (FU) (Day 90+/-7)|mITT Population||participants|||Number
794134|NCT00911300|Secondary|Number of Thrombus-negative and Thrombus-positive Participants With Conversion to Sinus Rhythm|Sinus rhythm is the normal beating of the heart, as measured by an ECG. Normal sinus rhythm not only indicates that the rhythm is normally generated by the sinus node and is traveling in a normal fashion in the heart, but it also indicates that the heart rate (the rate at which the sinus node is generating impulses) is within normal limits.|Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants; and from Day 64 until the follow-up visit (FU) (Day 90+/-7)|mITT Population||participants|||Number
794135|NCT00911300|Secondary|Number of Participants With a Thrombus in the Left Atrium (LA) or in the Left Atrial Appendage (LAA) at the Time of the Second TEE|Atrial fibrillation (AF) causes stagnant blood in the LA or LAA and can lead to a thromboembolism. Stasis in the LAA represents the principal mechanism of thrombus formation in AF.|At second TEE (at Day 28+/-4)|mITT Population. Only clot-positive participants at the time of the first TEE were analyzed.||participants|||Number
794136|NCT00911300|Secondary|Number of Participants With Primary Successful Electrical Cardioversion (CV) in Sinus Rhythm|CV may be performed electively to restore sinus rhythm in patients with persistent AF. The primary successful electric CV was assessed by a 12- lead electrocardiogram (ECG) directly after the CV. Results of the last cardioversion were used in cases for which more than one CV was performed.|Day 1 until Day 3|mITT Population. Only participants with data for primary successful electric cardioversion at the indicated timepoint were analyzed.||participants|||Number
794137|NCT00911300|Secondary|Number of Thrombus-negative and Thrombus-positive Participants With at Least One Minor Bleeding Event|Minor bleeding is defined as clinically overt bleeding events that do not meet the criteria for major or clinically relevant non-major bleeding. All episodes of bleeding were adjudicated by an independent CAC, the members of which were unaware of the participants' treatment assignment.|Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants; and from Baseline until the follow-up visit (FU) (Day 90+/-7)|mITT Population||participants|||Number
794153|NCT00911495|Other Pre-specified|Blood Flow and Biomarkers of Adhesion|As an exploratory outcome mean change in microvascular blood flow from baseline to each time point was measured. Microvascular blood flow was also measured as microFI, perfused vessel density, and RBC velocity.|48 hours||||||
794154|NCT00911495|Secondary|Total Plasma Clearance||48 hours|All subjects were analyzed for pharmacokinetics; one subject of the 15 enrolled was lost to follow-up.||mL/h/kg||Standard Deviation|Mean
794155|NCT00911495|Primary|Safety as Measured by the Number of Participants With Adverse Events||28 days|All enrolled subjects were analyzed for safety.||participants|||Number
794138|NCT00911300|Secondary|Number of Thrombus-negative and Thrombus-positive Participants With at Least One Major Bleeding Event|Major bleeding: fatal, and/or symptomatic in a critical area/ organ, causes a fall in hemoglobin of >=3 grams/deciliter compared with the pre-randomization level, or leads to the transfusion of >=2 units of whole blood/red blood cells. All bleeding events were adjudicated by a CAC, the members of which were unaware of the participants' treatment assignment. A thrombus/ blood clot is the final product of the blood coagulation step in hemostasis. It is achieved via the aggregation of platelets, and the activation of the humoral coagulation system (i.e., clotting factors).|Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants; and from Baseline until the follow-up visit (FU) (Day 90+/-7)|mITT Population||participants|||Number
794139|NCT00911300|Secondary|Number of Thrombus-negative and Thrombus-positive Participants Who Died From Any Cause|The cause of death was classified as due to a thromboembolic event (like cerebral infarction), bleeding, or other established diagnosis, or as unexplained. All deaths were adjudicated by an independent CAC, the members of which were unaware of the participants' treatment assignment. A thrombus or blood clot is the final product of the blood coagulation step in hemostasis. It is achieved via the aggregation of platelets that form a platelet plug, and the activation of the humoral coagulation system (i.e., clotting factors).|Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants; and from Baseline until the follow-up visit (FU) (Day 90+/-7)|mITT Population||participants|||Number
794140|NCT00911300|Secondary|Number of Thrombus-negative and Thrombus-positive Participants With at Least One Systemic Thromboembolism|Systemic thromboembolism comprises any arterial thromboembolic event (e.g., peripheral vascular embolism, mesenteric infarct, or myocardial infarction). All systemic thromboembolic events were adjudicated by a CAC, the members of which were unaware of the participants' treatment assignment. A thrombus or blood clot is the final product of the blood coagulation step in hemostasis. It is achieved via the aggregation of platelets that form a platelet plug, and the activation of the humoral coagulation system (i.e., clotting factors).|Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants; and from Baseline until the follow-up visit (FU) (Day 90+/-7)|mITT Population||participants|||Number
794141|NCT00911300|Secondary|Number of Thrombus-negative and Thrombus-positive Participants (Par.) With at Least One Cerebral Neurologic Event|Cerebral neurologic events are defined as any new neurologic disorders caused by cerebrovascular embolisation, e.g., TIA, cerebral infarction. All cerebral neurologic events were adjudicated by a CAC, members of which were unaware of the participants' treatment assignment.The cerebrovascular origin of the event was confirmed by objective procedures. A thrombus or blood clot is the final product of the blood coagulation step in hemostasis. It is achieved via the aggregation of platelets that form a platelet plug, and the activation of the humoral coagulation system (i.e., clotting factors).|Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants; and from Baseline until the follow-up visit (FU) (Day 90+/-7)|mITT Population||participants|||Number
794142|NCT00911300|Primary|Number of Participants With at Least One Event of Cerebral Neurologic Event, Systemic Thromboembolism, Death From Any Cause, and/or Major Bleeding Until the End of Treatment (EOT) Plus 4 Days|Cerebral neurologic events are defined as any new neurologic disorders caused by cerebrovascular embolization, e.g., Transient Ischemic Attack (TIA), cerebral infarction. The cerebrovascular origin of the event has to be confirmed by objective procedures. Systemic thromboembolism comprises any arterial thromboembolic event (e.g., peripheral vascular embolism, mesenteric infarct, or myocardial infarction). All cerebral neurologic events were adjudicated by a Central Adjudication Committee (CAC), members of which were unaware of the participants' treatment assignment.|Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants|Modified Intent-to-Treat (mITT) Population: all randomized participants receiving at least one dose of study medication and for whom any post-baseline value was available||participants|||Number
794143|NCT00911326|Secondary|Lymph Node Detection Rate|The rate of the subjects for whom Lymphoseek identified at least 1 sentinel lymph node. The detection rate point estimate was the observed rate and was made on a per-patient basis relative to all patients in the intent-to-treat population.|Surgery after injection of Lymphoseek|||percentage of participants||95% Confidence Interval|Number
794144|NCT00911326|Secondary|Overall Accuracy|The overall accuracy is calculated as a percentage from the ratio of (true positives + true negatives) / (true positives + false negatives + true negatives). The overall accuracy point estimate was the observed rate and was made on a per-patient basis relative to all patients in the intent-to-treat population.|Surgery after injection of Lymphoseek|||percentage of participants||95% Confidence Interval|Number
794145|NCT00911326|Secondary|Negative Predictive Value (NPV)|The NPV is calculated as a percentage from the ratio of true negatives to the sum of true negatives plus false negatives. The NPV point estimate was the observed rate and was made on a per-patient basis relative to patients predicted to be pathology-negative.|Surgery after injection of Lymphoseek|||% of participants predicted negative||95% Confidence Interval|Number
794146|NCT00911326|Primary|False Negative Rate (FNR)|The FNR is calculated as a percentage from the ratio of false negatives to the sum of true positives plus false negatives. The FNR point estimate was the observed rate and was made on a per-patient basis relative to patients with pathology-positive nodes.|Surgery after injection of Lymphoseek|||% of pathology-positive participants||95% Confidence Interval|Number
794147|NCT00911443|Primary|Overall Tumor Response|Tumor response is measured according to Response Evaluation Criteria In Solid Tumors (RECIST) computing number of Complete Response plus Partial Response|1 year|||participants|||Number
794148|NCT00911443|Secondary|Progression Free Survival|Progression Free Survival is defined as the time from the randomization to progression or death|2 years|||months||95% Confidence Interval|Median
794149|NCT00911443|Secondary|Overall Survival|The survival time for each patient is defined as the time between randomization and death. Patients lost to follow-up or still alive at the date of last evaluation have been censored.|2 years|||months||95% Confidence Interval|Median
794150|NCT00911495|Secondary|Volume of the Peripheral Compartment||48 hours|||mL/kg||Standard Deviation|Mean
794151|NCT00911495|Secondary|Intercompartmental Clearance||48 hours|||mL/h/kg||Standard Deviation|Mean
794158|NCT00911534|Primary|Mean Percentage of Diary-Recorded Heartburn-Free Days at Week 4|Participants completed a daily symptom diary. A heartburn-free day was defined as participant report of 'No Heartburn' from nighttime and daytime of the diary for the same day.|Week 4|Intent-to-Treat (ITT) Population - all randomized participants who received at least 1 dose of study drug (n=number of participants with evaluable data)||Percentage of Days||Standard Deviation|Mean
794159|NCT00911534|Secondary|Change From Baseline in Average Daily Severity Score of Gastroesophageal Reflux Disease (GERD)-Related Symptoms at Week 4|Participants collected GERD-associated symptoms of daytime heartburn, nighttime heartburn and regurgitation in daily symptom diary. Daytime episodes were defined as those that occurred after arising in the morning until retiring in the evening, and nighttime episodes were defined as those that occurred during the night while sleeping or trying to sleep. The severity score was calculated was based on a 5-point Likert scale ranging from 0 (no symptom) to 4 (very severe symptom); higher scores indicated greater disease activity.|Baseline and Week 4|ITT||Scores on a Scale||Standard Deviation|Mean
794160|NCT00911547|Secondary|Mean Change From Baseline in Nocturnal Asthma Score on the Overnight Asthma Symptoms Diary in Nocturnal Asthmatic Patients Only|"Mean change from baseline in Nocturnal asthma score; the patient scored his/her symptoms [from 0 (best) to 3 (worst)] on a daily basis. Responses to the question, Did you wake up with asthma symptoms? (no, once, more than once, awake “all night”), were assigned numerical values (0, 1, 2, 3, respectively).
The average score for the visit was determined by averaging the daily scores over all days between consecutive visits."|Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups|Efficacy analyses were based on the intention-to-treat principle, i.e., inclusion of all patients with a baseline and at least one postbaseline measurement. No missing values for this analysis were imputed. Data collected during discontinuation visits and unscheduled visits were included in this analysis.||Units on a Scale||95% Confidence Interval|Least Squares Mean
794161|NCT00911547|Secondary|Mean Change From Baseline in Morning Peak Flow Rate (PEFR) in Patients With Chronic Asthma|Morning PEFR was measured in triplicate immediately upon arising before taking any medication and the best value recorded on the overnight asthma symptoms diary. The mean morning PEFR for the visit was determined by averaging all valid PEFR measurements for the days between consecutive visits.|Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups|Efficacy analyses were based on the intention-to-treat principle, i.e., inclusion of all patients with a baseline and at least one postbaseline measurement. No missing values for this analysis were imputed. Data collected during discontinuation visits and unscheduled visits were included in this analysis.||Liters/minute||95% Confidence Interval|Least Squares Mean
794162|NCT00911547|Secondary|Mean Percent Change From Baseline in Total Daily Beta-agonist Medication Use|Beta-agonist medication use from the daytime and overnight asthma symptoms diaries for each 24-hour period was added to determine the daily total number of puffs used. The average daily number of puffs for the visit was determined as the average daily number of puffs over all days between consecutive visits.|Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups|Efficacy analyses were based on the intention-to-treat principle, i.e., inclusion of all patients with a baseline and at least one postbaseline measurement. No missing values for this analysis were imputed. Data collected during discontinuation visits and unscheduled visits were included in this analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
794163|NCT00911547|Primary|Mean Change From Baseline in Daytime Symptom Score on the Daytime Asthma Symptoms Diary in Patients With Chronic Asthma|"The daily daytime symptom score was determined by averaging the daily scores (the patient scored his/her symptoms [from 0 (best) to 6 (worst)] on a daily basis.) for the four questions on the Daytime Asthma Symptoms Diary.
The average daytime symptom score for the visit was determined by averaging the daily symptom scores over all days between two consecutive visits."|Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups|Primary efficacy analyses were based on the intention-to-treat principle, i.e., inclusion of all patients with a baseline and at least one postbaseline measurement. No missing values for this analysis were imputed. Data collected during discontinuation visits and unscheduled visits were included in this analysis.||Units on a Scale||95% Confidence Interval|Least Squares Mean
794164|NCT00911547|Primary|Mean Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) in Patients With Chronic Asthma|Mean percent change from baseline in FEV1 in patients with chronic asthma averaged over 16 weeks for the Beclo and MK+ Beclo groups and averaged over last 10 weeks for the Placebo and MK groups|Baseline & over 16 weeks for the Beclomethasone (Beclo) and Montelukast (MK) + Beclo groups and over last 10 weeks for the Placebo and MK groups|Primary efficacy analyses were based on the intention-to-treat principle, i.e., inclusion of all patients with a baseline and at least one postbaseline measurement. No missing values were imputed. Data collected during discontinuation and unscheduled visits were included the analysis. Differences between treatments are evaluated based on LS means||Percentage of Change||95% Confidence Interval|Least Squares Mean
794165|NCT00911612|Secondary|Stool Consistency|"The subjects rated their stool consistency using the Bristol Stool Scale. The Bristol Stool Scale is a medical aid designed to classify the form of human feces into seven categories or types. Types 1 and 2 indicate constipation with 3 and 4 being the ideal stools especially the latter, as they are the easiest to defecate, and 5-7 tending towards diarrhea."|After 12-14 days' treatment|||units on a scale||Standard Error|Mean
794166|NCT00911612|Secondary|Colonic Transit, Geometric Center at 48 Hours|The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit. A GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.|After 12-14 days' treatment|||units on a scale||Standard Error|Mean
794167|NCT00911612|Secondary|Colonic Permeability as Measured by Cumulative Urinary Excretion of Mannitol 8-24 Hours|Colonic permeability is measured through differential excretion of urine saccharides. The subject ingests a methacrylate-coated capsule that contains saccharides (mannitol 1g and lactulose 5 g powder). The capsule provides a means to protect the sugars from absorption, until the sugars are delivered to the colon by means of a standard delayed release capsule. The value reported is the mean for each arm of the total amount of mannitol excreted over the 8-24 hour time period.|after 12-14 days' treatment|||mg||Standard Error|Mean
794168|NCT00911612|Primary|Ascending Colon Emptying T1/2|The half time for the ascending colon emptying (T1/2) was measured by the scintigraphic method. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule that is swallowed by the subject. Anterior and posterior gamma images are taken hourly. From the hourly scans, a time-activity curve is plotted using linear interpolation between time points when content was measured. The time taken to empty 50% of the isotope from the ascending colon is read from this time-activity curve.|After 12-14 days' treatment|||hours||Standard Error|Mean
794169|NCT00911612|Primary|Colonic Transit, Geometric Center at 24 Hours|The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit. A GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.|After 12-14 days treatment|||units on a scale||Standard Error|Mean
794170|NCT00911625|Secondary|The Number of Participants Who Experience at Least One Blood Glucose Level Below 70 Milligrams Per Deciliter|At the end of the study, the number of participants who experience at least one blood glucose level below 70 milligrams per deciliter (mg/dL) is compared between the two treatment cohorts|6 Days|This analysis comprises all participants who were randomized and completed all study activities||Participants|||Count of Participants
794171|NCT00911625|Primary|Average Blood Glucose Over 6 Days|Participants have their blood glucose measured daily for six days. The average blood glucose measure over all six days is compared between the two treatment cohorts.|6 Days|The analysis population for the primary outcome comprises all participants who were randomized and completed all study activities||milligrams per deciliter||Standard Deviation|Mean
794172|NCT00911742|Secondary|Tmax|Time to maximum plasma concentration|48 hours|||hours||Full Range|Median
794173|NCT00911742|Secondary|t1/2|Apparent terminal elimination half-life|48 hours|||hours||Standard Deviation|Mean
794174|NCT00911742|Primary|Cmax|Maximum plasma concentration|48 hours|||ng/mL||Standard Deviation|Mean
794175|NCT00911742|Primary|AUC (0-∞)|"The area under the plasma concentration curve was estimated by extrapolating to infinity AUC0–t. The extrapolation to infinity was done by regression with the last log-transformed data to estimate the terminal area by means of the line that maximized R’2 (coefficient of determination). The units are ng.h/mL.
h=hours"|48 hours|||ng.h/mL||Standard Deviation|Mean
794176|NCT00911742|Primary|AUC(0-t)|"Area under the plasma concentration versus time curve to the last measured concentration.
h=hour"|48 hours|||ng.h/mL||Standard Deviation|Mean
794177|NCT00911768|Secondary|Unstimulated Salivary Flow Rates|Unstimulated salivary flow rates were compared between 0 and 8 weeks in both groups.|8 weeks|Because secondary outcome of the study was changes of unstimulated salivary flow rates between 0 and 8 weeks, per protocol analysis was applied.||ml/min||Standard Deviation|Mean
794178|NCT00911768|Secondary|Stimulated Salivary Flow Rates|Stimulated salivary flow rates were compared between 0 and 8 weeks in both groups.|8 weeks|Because secondary outcome of the study was also changes of stimulated salivary flow rates between 0 and 8 weeks, per protocol analysis was applied.||ml/min||Standard Deviation|Mean
794179|NCT00911768|Primary|Visual Analogue Scale of Subjective Dry Mouth|Visual Analogue Scale of Subjective Dry Mouth is 10 cm, where 0 cm indicates no dry mouth and 10 cm the severe dry mouth.|8 weeks|Because primay outcome of the study was changes of Visual Analogue Scale of Subjective Dry Mouth between 0, 4 and 8 weeks, per protocol analysis was applied.||cm||Standard Deviation|Mean
794180|NCT00911807|Secondary|Adverse Experiences, Vital Signs, Physical and Neurological Examinations, Laboratory Tests (Hematology, Clinical Chemistry , Urinalysis, Electrocardiogram [ECG])||Baseline, week 4, 12, 16, 28||||||
794181|NCT00911807|Secondary|Combined Responders, i.e. Response in ADAS-COG+ and CIBIC+||week 4, 12, 16, 28||||||
794182|NCT00911807|Secondary|Change From Baseline in Total Score for Neuropsychiatric Inventory (NPI)||week 16, 28||||||
794183|NCT00911807|Secondary|Change From Baseline for Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL)||week 16, 28||||||
794184|NCT00911807|Secondary|Clinical Interview-based Impression of Severity (CIBIS+) Score||week 28||||||
794185|NCT00911807|Secondary|CIBIC+ Responders||week 4, 12, 16, 28||||||
794186|NCT00911807|Secondary|CIBIC+ Score||week 4, 12, 16||||||
794187|NCT00911807|Secondary|Change From Baseline for Original ADAS-COG||week 4, 12, 16, 28||||||
794188|NCT00911807|Secondary|ADAS-COG+ Responders||week 4, 12, 16, 28||||||
794189|NCT00911807|Secondary|Change From Baseline for ADAS-COG+||week 4, 12, 16||||||
794190|NCT00911807|Primary|Clinical Interview-based Impression of Change (CIBIC+) Score||week 28||||||
794191|NCT00911807|Primary|Change From Baseline in Alzheimer’s Disease Assessment Scale Cognitive Subpart (Extended Version) (ADAS-COG+) at Week 28|The ADAS-cog+ is a validated, widely used, 14 item psychometric instrument for testing cognitive functions with increased sensitivity in detecting changes in milder patients compared to the original ADAS-cog. It has a maximum score of 85 with a higher score indicating impairment and was assessed by a qualified neuropsychologist.|baseline and week 28|Analysis was intention to treat||points on a scale||Standard Deviation|Mean
794192|NCT00911859|Secondary|Change From Baseline to Cycle 9 in Global Health Status/Quality of Life Subscale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ C30)|"Global health status/quality of life is a subscale of the EORTC QOL C30, which comprises two questions related to overall health/quality of life during the past week. The raw score to each question ranged from 1 (very poor) to 7 (excellent). The raw mean score of health status/quality of life subscale is calculated for each participant and a linear transformation applied to standardize the raw score, so that scores range from 0 to 100; a higher score represents a higher (better) health and quality of life."|Baseline (Day 1 predose) and Cycle 9 (Week 54)|Intent-to-treat (ITT) population: all randomized participants with evaluable data during baseline and Cycle 9||Scores on a scale||Standard Deviation|Mean
794193|NCT00911859|Secondary|Overall Survival|Overall survival is defined as the time interval in days between the date of randomization and the participant's death from any cause.|From the date of randomization till the date of death, as assessed up to the end of study (approximately 3 years)|Intent-to-treat (ITT) population: all randomized participants.||Days||95% Confidence Interval|Median
794195|NCT00911859|Secondary|Duration of Response (DOR)|DOR was defined as length from the earliest date a participant achieved a complete response (CR) or partial response (PR) to either date for disease progression (including relapse from CR) or the censoring date for progressive disease. Responders without disease progression were censored at the last efficacy assessment for disease progression.|From the date participants achieved CR or PR to either date for disease progression (including relapse from CR) or the censoring date for progressive disease, as assessed Up to 30 days after last dose of study medication|Included participants in the randomized population who achieved CR or PR.||Days||95% Confidence Interval|Median
794196|NCT00911859|Secondary|1-year Progression-Free Survival (PFS) Rate|The 1-year PFS rate was defined as the percentage of participants surviving 1 year after randomization without disease progression or death.|1 year|Intent-to-treat (ITT) population: all randomized participants||Percentage of participants|||Number
794197|NCT00911859|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time between randomization and either disease progression or death, whichever occurred first.|From the date of randomization until disease progression or death, whichever occurred first, as assessed up to the last efficacy assessment for disease progression (approximately 3 years)|Intent-to-treat (ITT) population: all randomized participants.||Days||95% Confidence Interval|Median
794198|NCT00911859|Secondary|Percentage of Participants Who Achieved Stringent Complete Response (sCR) - International Myeloma Working Group (IMWG) Criteria|sCR was assesses by IMWG Criteria: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, <=5% plasma cells in bone marrow, normal free light chain ratio, absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence. sCR is a CR that has been confirmed by immunofixation + free light chain assay + either bone marrow immunohistochemistry or immunofluorescence|Up to disease progression, approximately 3 years|Response-evaluable population: Participants who had a confirmed diagnosis of multiple myeloma and measurable disease according to the EBMT criteria were evaluated for disease response. Also, participants must have received at least 1 administration of study medication and have at least 1 post-baseline disease assessment.||Percentage of participants|||Number
794199|NCT00911859|Secondary|Percentage of Participants Who Achieved Overall Response ie, Complete Response (CR) or Partial Response (PR) - European Group for Blood and Marrow Transplantation (EBMT) Criteria|CR or PR was assessed using EBMT criteria. CR: disappearance of the original monoclonal paraprotein from the blood and urine on at least 2 determinations for a minimum of 6 weeks by immunofixation studies, <5% plasma cells in the bone marrow on at least 1 determination, if skeletal survey is available: no increase in the size or number of lytic bone lesions (development of a compression fracture does not exclude response), disappearance of soft tissue plasmacytomas for at least 6 weeks; PR: >=50% reduction in the level of serum monoclonal paraprotein for at least 2 determinations 6 weeks apart, if present, reduction in 24-hour urinary light chain excretion by either >=90% or to <200 mg for at least 2 determinations 6 weeks apart, >=50% reduction in the size of soft tissue plasmacytomas (by clinical or radiographic examination) for at least 6 weeks, if skeletal survey is available: no increase in size or number of lytic bone lesions|Up to disease progression, approximately 3 years|Response-evaluable population: Participants who had a confirmed diagnosis of multiple myeloma and measurable disease according to the EBMT criteria were evaluated for disease response. Also, participants must have received at least 1 administration of study medication and have at least 1 post-baseline disease assessment.||Percentage of participants|||Number
794200|NCT00911859|Primary|Percentage of Participants Who Achieved Complete Response (CR) - European Group for Blood and Marrow Transplantation (EBMT) Criteria|CR was assessed using EMBT criteria: disappearance of the original monoclonal paraprotein from the blood and urine on at least 2 determinations for a minimum of 6 weeks by immunofixation studies, <5% plasma cells in the bone marrow on at least 1 determination, if skeletal survey is available: no increase in the size or number of lytic bone lesions (development of a compression fracture does not exclude response), disappearance of soft tissue plasmacytomas for at least 6 weeks.|Up to disease progression, approximately 3 years|Response-evaluable population: Participants who had a confirmed diagnosis of multiple myeloma and measurable disease according to the EBMT criteria were evaluated for disease response. Also, participants must have received at least 1 administration of study medication and have at least 1 post-baseline disease assessment.||Percentage of participants|||Number
794201|NCT00911898|Primary|Maximum Tolerated Dose (MTD) or Maximum Feasible Dose|The Maximum Tolerated Dose (MTD) was defined as the highest dose level in which a DLT is experienced by fewer than two patients in a cohort of 3 - 6 patients. If a DLT is observed in at least two patients in a cohort of 3 – 6 patients, the MTD will be determined to have been exceeded and an additional three patients (up to a total of six) are to be treated at the next lower dose level.|28 days|||mg/kg|||Number
794202|NCT00911898|Secondary|To Explore the Role Functional Imagining (FDG-PET CT Scan), as a Predictor of Clinical Activity||December 2011||||||
794203|NCT00911898|Secondary|To Determine the Clinical Activity of MM-111 in Patients Based on Objective Response Rate (ORR), Duration of Response (DoR), Progression Free Survival (PFS), and 16 & 24-week Clinical Benefit Rate (CBR)||December 2011||||||
794204|NCT00911937|Secondary|Change From Baseline in Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 4 and 12|OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.|Baseline, Week 4 and 12|FAS population included all participants who received at least 1 dose of study drug and had at least baseline or a post-baseline efficacy assessment. Here, ‘N’ (number of participants analyzed) signifies those participants who had non-missing change from baseline value at Week 12.||units on a scale||Standard Error|Least Squares Mean
794236|NCT00912015|Primary|Adverse Events: 12-months Safety Population|Spontaneous adverse events were recorded for patients who received the same dose for at least 350 days. A treatment emergent adverse event (TEAE) was associated to the dose level on which a patient was 2 days prior to the TEAE. Only TEAEs which could be associated with the dose level on which the patient was for the longest time were considered.|12 months|Patients who received the same dose for at least 350 days (12 months)||participants|||Number
794205|NCT00911937|Secondary|Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q)|OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.|Baseline|FAS population included all participants who received at least 1 dose of study drug and had at least baseline or a post-baseline efficacy assessment. Here, ‘N’ (number of participants analyzed) signifies those participants who had non-missing change from baseline value at Week 12.||units on a scale||Standard Deviation|Mean
794206|NCT00911937|Secondary|Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 4 and 12|OAB-q: a self-administered, 33-item, questionnaire that assesses how much the participant has been bothered by selected bladder symptoms. Each item rated by participant on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score – lowest possible value of raw score)/range]*100. Higher scores values indicative of greater symptom bother.|Baseline, Week 4 and 12|FAS population included all participants who received at least 1 dose of study drug and had at least baseline or a post-baseline efficacy assessment. Here, ‘N’ (number of participants analyzed) signifies those participants who had non-missing change from baseline value at Week 12.||units on a scale||Standard Deviation|Least Squares Mean
794207|NCT00911937|Secondary|Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score|OAB-q: a self-administered, 33-item, questionnaire that assesses how much the participant has been bothered by selected bladder symptoms. Each item rated by participant on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score – lowest possible value of raw score)/range]*100. Higher scores values indicative of greater symptom bother.|Baseline|FAS population included all participants who received at least 1 dose of study drug and had at least baseline or a post-baseline efficacy assessment. Here, ‘N’ (number of participants analyzed) signifies those participants who had non-missing change from baseline value at Week 12.||units on a scale||Standard Deviation|Mean
794208|NCT00911937|Secondary|Change From Baseline in Mean Voided Volume Per Micturition at Week 12|Mean voided volume per micturition was calculated as sum of voided volume divided by the total number of total micturition episodes with a recorded voided volume greater than 0 at that visit.|Baseline and Week 12|FAS population. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline voided volume per micturition greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||mL||Standard Error|Least Squares Mean
794209|NCT00911937|Secondary|Mean Voided Volume Per Micturition|Mean voided volume per micturition was calculated as sum of voided volume divided by the total number of total micturition episodes with a recorded voided volume greater than 0 at that visit.|Baseline|FAS population. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline voided volume per micturition greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||mL||Standard Deviation|Mean
794210|NCT00911937|Secondary|Change From Baseline in Mean Voided Volume Per Nocturnal Micturition at Week 12|Mean voided volume per nocturnal micturition was calculated as sum of voided volume during bedtime divided by the total number of bedtime micturition episodes with a recorded voided volume greater than 0 at that visit.|Baseline and Week 12|FAS population. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline voided volume per nocturnal micturition greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||mL||Standard Error|Least Squares Mean
794211|NCT00911937|Secondary|Mean Voided Volume Per Nocturnal Micturition|Mean voided volume per nocturnal micturition was calculated as sum of voided volume during bedtime divided by the total number of bedtime micturition episodes with a recorded voided volume greater than 0 at that visit.|Baseline|FAS population. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline voided volume per nocturnal micturition greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||milliliter (mL)||Standard Deviation|Mean
794212|NCT00911937|Secondary|Change From Baseline in Frequency-urgency Sum Rating Per 24 Hours at Week 4 and 12|Frequency-urgency sum is total USS ratings recorded for all micturitions in 24-hour day. Number of USS ratings per 24 hours is sum of all USS ratings divided by the total diary days collected at that visit. USS scale: 1=No feeling of urgency to 5=Unable to hold: leak urine. Numerical decrease indicates improvement.|Baseline, Week 4 and 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline frequency-urgency sum rating greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||units on a scale||Standard Deviation|Least Squares Mean
794213|NCT00911937|Secondary|Frequency-urgency Sum Rating Per 24 Hours|Frequency-urgency sum is total USS ratings recorded for all micturitions in 24-hour day. Number of USS ratings per 24 hours is sum of all USS ratings divided by the total diary days collected at that visit. USS scale: 1=No feeling of urgency to 5=Unable to hold: leak urine.|Baseline|FAS population. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline frequency-urgency sum rating greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||units on a scale||Standard Deviation|Mean
794214|NCT00911937|Secondary|Change From Baseline in Nocturnal Frequency-urgency Sum Rating Per 24 Hours at Week 4 and 12|Frequency-urgency sum is total USS ratings recorded for all nocturnal micturitions in 24-hour day. Number of USS ratings per 24 hours is sum of all USS ratings divided by the total diary days collected at that visit. USS scale: 1=No feeling of urgency to 5=Unable to hold: leak urine. Numerical decrease indicates improvement.|Baseline, Week 4 and 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline nocturnal frequency-urgency sum rating greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||units on a scale||Standard Error|Least Squares Mean
794215|NCT00911937|Secondary|Nocturnal Frequency-urgency Sum Rating Per 24 Hours|Frequency-urgency sum is total USS ratings recorded for all nocturnal micturitions in 24-hour day. Number of USS ratings per 24 hours is sum of all USS ratings divided by the total diary days collected at that visit. USS scale: 1=No feeling of urgency to 5=Unable to hold: leak urine. Numerical decrease indicates improvement.|Baseline|FAS population. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline nocturnal frequency-urgency sum rating greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||units on a scale||Standard Deviation|Mean
794216|NCT00911937|Secondary|Percent Change From Baseline in of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 and 12|Percent change of UUI episodes per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (100*(Week 4 or 12 - baseline)/baseline).|Baseline, Week 4 and 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline UUI episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||percent change||Standard Deviation|Mean
794217|NCT00911937|Secondary|Change From Baseline in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 and 12|UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Week 4 and 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline UUI episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||episodes per 24 hours||Standard Error|Least Squares Mean
794218|NCT00911937|Secondary|Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours|UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline|FAS population included all participants who received at least 1 dose of study drug and had at least baseline or a post-baseline efficacy assessment. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline UUI episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||episodes per 24 hours||Standard Deviation|Mean
794219|NCT00911937|Secondary|Percent Change From Baseline in Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12|Percent change of micturition-related urgency episodes per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (100*(Week 4 or 12 - baseline)/baseline).|Baseline, Week 4 and 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||percent change||Standard Deviation|Mean
794220|NCT00911937|Secondary|Change From Baseline in Number of Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12|The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Week 4 and 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||episodes per 24 hours||Standard Error|Least Squares Mean
794221|NCT00911937|Secondary|Number of Micturition-related Urgency Episodes Per 24 Hours|The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline|FAS population included all participants who received at least 1 dose of study drug and had at least baseline or a post-baseline efficacy assessment. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||episodes per 24 hours||Standard Deviation|Mean
794222|NCT00911937|Secondary|Percent Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12|Percent change of micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (100*(Week 4 or 12 - baseline)/baseline).|Baseline, Week 4 and 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline micturition frequency greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||percent change||Standard Deviation|Mean
794223|NCT00911937|Secondary|Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4 and 12|Micturitions include episodes of voluntary micturition and episodes of UUI. UUI episodes were defined as those micturitions with USS rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine.|Baseline, Week 4 and 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline micturition frequency greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||micturitions per 24 hours||Standard Error|Least Squares Mean
794224|NCT00911937|Secondary|Mean Number of Micturitions Per 24 Hours|Micturitions include episodes of voluntary micturition and episodes of Urgency Urinary Incontinence [UUI]. UUI episodes were defined as those micturitions with USS rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine.|Baseline|FAS population included all participants who received at least 1 dose of study drug and had at least baseline or a post-baseline efficacy assessment. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline micturition frequency greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||micturitions per 24 hours||Standard Deviation|Mean
794292|NCT00905580|Primary|Number of Patients Who Required Additional Analgesics During the First 48 Hours Postoperatively||1, 6, 24 & 48 hours|||participants|||Number
794225|NCT00911937|Secondary|Percent Change From Baseline in Nocturnal Micturitions Per 24 Hours at Week 4 and 12|Percent change of nocturnal micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (100*(Week 4 or 12 - baseline)/baseline).|Baseline, Week 4 and 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline nocturnal micturition frequency greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||percent change||Standard Deviation|Mean
794226|NCT00911937|Secondary|Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Week 4 and 12|Nocturnal micturitions were defined as micturitions with USS rating 1-5 that occurred between the time the participant went to bed and the time he or she arose to start the next day. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The mean number of nocturnal micturitions per 24 hours was calculated as the total number of nocturnal micturitions divided by the total number of diary days collected at that visit.|Baseline, Week 4 and 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline nocturnal micturition frequency greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||micturitions per 24 hours||Standard Error|Least Squares Mean
794227|NCT00911937|Secondary|Number of Nocturnal Micturitions Per 24 Hours|Nocturnal micturitions were defined as micturitions with USS rating 1-5 that occurred between the time the participant went to bed and the time he or she arose to start the next day. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The mean number of nocturnal micturitions per 24 hours was calculated as the total number of nocturnal micturitions divided by the total number of diary days collected at that visit.|Baseline|FAS population. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline nocturnal micturition frequency greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||micturitions per 24 hours||Standard Deviation|Mean
794228|NCT00911937|Secondary|Percent Change From Baseline in Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 4 and 12|Percent change of micturition-related nocturnal urgency episodes per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (100*(Week 4 or 12 - baseline)/baseline).|Baseline, Week 4 and 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline nocturnal urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||percent change||Standard Deviation|Mean
794229|NCT00911937|Secondary|Change From Baseline in Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 4|Micturition-related nocturnal urgency episodes had USS rating of 3 or more that occurred between time participant went to bed and time he or she arose to start next day. Number of micturition-related nocturnal urgency episodes per 24 hours was calculated as sum of all nocturnal micturition-related urgency episodes divided by total number of diary days collected at that visit.|Baseline and Week 4|FAS population included all participants who received at least 1 dose of study drug and had at least baseline or a post-baseline efficacy assessment. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline nocturnal urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 4.||episodes per 24 hours||Standard Error|Least Squares Mean
794230|NCT00911937|Primary|Change From Baseline in Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 12|Micturition-related nocturnal urgency episodes had USS rating of 3 or more that occurred between time participant went to bed and time he or she arose to start next day. Number of nocturnal micturition-related urgency episodes per 24 hours was calculated as sum of all nocturnal micturition-related urgency episodes divided by total number of diary days collected at that visit.|Baseline and Week 12|FAS population. Last observation carried forward (LOCF) method was used to impute missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline nocturnal urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||episodes per 24 hours||Standard Error|Least Squares Mean
794231|NCT00911937|Primary|Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours|Micturition-related nocturnal urgency episodes had urinary sensation scale (USS) rating of 3 or more that occurred between time participant went to bed and time he or she arose to start next day. Number of nocturnal micturition-related urgency episodes per 24 hours was calculated as sum of all nocturnal micturition-related urgency episodes divided by total number of diary days collected at that visit.|Baseline|Full analysis set (FAS): all participants who received at least 1 dose of study drug and had at least baseline or a post-baseline efficacy assessment. Here, ‘N’(number of participants analyzed) signifies those participants who had baseline nocturnal urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||episodes per 24 hours||Standard Deviation|Mean
794232|NCT00911989|Primary|Proportion of Procedures Completed With Successful Endoscopic Visualization.|The goal of the study was to evaluate the feasibility of endoscopic visualization during a laparoscopic sleeve gastrectomy procedure using an endoscope inserted transvaginally through a steerable flex trocar. The number of subjects in whom the procedure was completed with endoscopic visualization was recorded.|Assessed intra-operatively|All subjects on whom the surgery was attempted represent the primary analysis population.||participants|||Number
794233|NCT00912002|Secondary|Number of Participants Who Discontinued the Study Due to An Adverse Event||Up to 14 days after study drug administration|All treated participants.||participants|||Number
794234|NCT00912002|Secondary|Number of Participants Who Experienced An Adverse Event||Up to 14 days after study drug administration|All treated participants.||participants|||Number
794235|NCT00912002|Primary|Mean Percent of Dose Recovered in Urine and Feces Following a Single Oral Dose of [^14C]MK-0941 (160 µCi).|Urine was collected at predose, 0 to 4, 4 to 8, 8 to 12, and 12 to 24 hr postdose, and at 24 hr intervals through subject discharge. Feces were collected at pre-dose and at 24 hr intervals through subject discharge. Subjects were discharged when the total recovery in urine and feces ≥90% of the administered dose or the recovery in urine and feces for two consecutive 24-hr intervals was ≤ 1%.|Up to 168 hours after study drug administration|All treated participants.||Percent Recovered||Standard Deviation|Mean
794238|NCT00912028|Primary|Corneal Staining|Subject distribution according to corneal staining with fluorescein scale in each eye during the 2-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.|2 weeks|Analysis was on those subjects who were enrolled, randomized to a study arm, and completed the study.||eyes|eyes||Number
794239|NCT00912028|Primary|Bulbar Hyperemia (Redness)|Subject distribution according to bulbar hyperemia scale in each eye during the 4-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.|4 weeks|Analysis is on those who are enrolled, randomized to a study arm, and completed the study.||eyes|eyes||Number
794240|NCT00912028|Primary|Bulbar Hyperemia (Redness)|Subject distribution according to bulbar hyperemia scale in each eye during the 2-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.|2 weeks|||eyes|eyes||Number
794241|NCT00912028|Primary|Limbal Hyperemia (Redness)|Subject distribution according to limbal hyperemia scale in each eye during the 4-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.|4 weeks|Analysis is on those subjects who are enrolled, randomized to a study arm, and who completed the study.||eyes|eyes||Number
794242|NCT00912028|Primary|Limbal Hyperemia (Redness)|Subject distribution according to limbal hyperemia scale in each eye during the 2-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.|2 weeks|Analysis is on those subjects who were enrolled, randomized, and completed the study.||eyes|eyes||Number
794243|NCT00912093|Secondary|Time to Investigator-Assessed Initial Symptom Improvement|Time to initial symptom improvement was calculated from the time of study drug administration to initial symptom improvement as determined by the investigator as the time they felt symptoms were starting to improve. Subjects who did not achieve initial symptom improvement within the observation period were censored at the last observation time.|Up to 120 hours post-dose|Non-laryngeal Intent-to-Treat (nl-ITT) population included all subjects with non-laryngeal attacks of HAE randomized to treatment. Subjects were analyzed according to the randomized treatment regardless of the treatment actually received. This was the primary analysis population for efficacy.||Hours||95% Confidence Interval|Median
794244|NCT00912093|Secondary|Time to Subject-Assessed Initial Symptom Improvement|Time to initial symptom improvement was calculated from the time of study drug administration to initial symptom improvement as determined by the subject as the time they felt symptoms were starting to improve. Subjects who did not achieve initial symptom improvement within the observation period were censored at the last observation time.|Up to 120 hours post-dose|Non-laryngeal Intent-to-Treat (nl-ITT) population included all subjects with non-laryngeal attacks of HAE randomized to treatment. Subjects were analyzed according to the randomized treatment regardless of the treatment actually received. This was the primary analysis population for efficacy.||Hours||95% Confidence Interval|Median
794245|NCT00912093|Secondary|Time to Almost Complete Symptom Relief|Time to almost complete symptom relief was calculated from the time of study drug administration to almost complete symptom relief, where almost complete symptom relief was defined as the earliest of 3 consecutive non-missing measurements in which all VAS scores <10 mm. Subjects who did not achieve almost complete symptom relief within the observation period were censored at the last observation time.|Up to 120 Hours post treatment|Non-laryngeal Intent-to-Treat (nl-ITT) population included all subjects with non-laryngeal attacks of HAE randomized to treatment. Subjects were analyzed according to the randomized treatment regardless of the treatment actually received. This was the primary analysis population for efficacy.||Hours||95% Confidence Interval|Median
794246|NCT00912093|Secondary|Time to Onset of Primary Symptom Relief|Time to primary symptom relief was calculated from the time of study drug administration to the onset of primary symptom relief, where onset of primary symptom relief was determined using the subject-assessed VAS score for a single primary symptom (determined by edema location) and defined as the earliest of 3 consecutive non-missing measurements in which a pre-specified reduction from the pretreatment value was met. Subjects who did not achieve primary symptom relief within the observation period were censored at the last observation time.|Up to 120 hours post-dose|Non-laryngeal Intent-to-Treat (nl-ITT) population included all subjects with non-laryngeal attacks of HAE randomized to treatment. Subjects were analyzed according to the randomized treatment regardless of the treatment actually received. This was the primary analysis population for efficacy.||Hours||95% Confidence Interval|Median
794247|NCT00912093|Primary|Time to Onset of Symptom Relief for an Acute Attack, as Assessed by the Patient|Time to onset of symptom relief was calculated from study drug administration to onset of symptom relief, where onset of symptom relief was defined as the earliest of 3 consecutive measurements in which there was a 50% reduction from pretreatment in composite VAS score. Composite VAS score comprised 3 symptoms, including skin swelling, skin pain, and abdominal pain, for cutaneous and abdominal attacks and 5 symptoms, including skin swelling, skin pain, abdominal pain, difficulty swallowing, and voice change, for laryngeal attacks. Subjects who did not achieve symptom relief within the observation period were censored at the last observation time.|Up to 120 hours post-dose|Non-laryngeal Intent-to-Treat (nl-ITT) population included all subjects with non-laryngeal attacks of HAE randomized to treatment. Subjects were analyzed according to the randomized treatment regardless of the treatment actually received. This was the primary analysis population for efficacy.||Hours||95% Confidence Interval|Median
794248|NCT00912158|Primary|Number of Patients Who Were Intubated|Number of patients who were subjected to endotracheal intubation and invasive mechanical ventilation|During ICU Stay|||participants|||Number
794249|NCT00912158|Secondary|Arterial Blood Gases, Respiratory Rate, Blood Pressure, Cardiac Output ,Intrapulmonary Shunt, A-a Oxygen Gradient, Heart Rate, and Dyspnea Duration of Hospital and ICU Stay and Mortality||Hospital stay||01/2010||||
794263|NCT00912288|Secondary|Number of Participants With Adverse Events (AEs)|Any untoward medical occurrence (including clinially important changes in clinical safety laboratory assessments, electrocardiograms and vital signs) in a participant who received study treatment was considered an AE without regard to possibility of causal relationship.|Baseline up to Week 30 (follow-up)|Safety analysis set included all participants who received at least 1 dose of study medication, including partial doses.||Participants|||Number
794264|NCT00912288|Secondary|Population Pharmacokinetic (PK) Analysis|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Pre-dose, 0.5 to 1.5 hours, 2.5 to 3.5 hours post-dose at Week 12||||||
794265|NCT00912288|Secondary|Euro Quality of Life - 5 Domain (EQ-5D) Assessment|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Total possible score ranged from 5 to 15; lower score indicated a better health state.|Baseline, Weeks 12, 26|Data for this outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early termination of the study.|||||
794266|NCT00912288|Secondary|Resource Utilization in Dementia-Lite Version (RUD-Lite)|RUD Lite: instrument used to assess amount of both formal and informal resources used by demented participants and primary caregiver. It was completed by caregivers and compiles data on following resources: use of social services, frequency and duration of hospitalizations, all contacts with health care professionals, participant living accommodations, amount of time the caregiver spends giving care and the impact of care giving on the caregiver’s job. Overall cost of care was evaluated to quantify resources utilized.|Baseline, Weeks 12, 18, 26|Data for this outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early termination of the study.|||||
794267|NCT00912288|Secondary|Clinician’s Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus) Scores|Alzheimer’s Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) version of CIBIC-Plus was used to assess participant’s overall disease severity. The corresponding baseline assessment rated participant on 7-point scale: (1) extremely severe AD to (7) no symptoms of AD. Overall impression of change from baseline was rated on a 7-point scale: 1=marked improvement; 2=moderate improvement; 3=minimal improvement; 4=no change; 5=minimal worsening; 6=moderate worsening; 7=marked worsening; all assessments are relative to baseline. Higher score = worsening of global function.|Week 26|Data for this outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early termination of the study.|||||
794268|NCT00912288|Secondary|Change From Baseline in the Mini-Mental State Examination (MMSE) Score at Week 26|MMSE measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. Total score derived from sub-scores; total ranged from 0 to 30, higher score indicates better cognitive state.|Baseline, Week 26|Data for this outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early termination of the study.|||||
794269|NCT00912288|Secondary|Sum of the Delusions and Hallucinations Sub-domain Scores of the NPI|NPI is a 12-domain caregiver assessment of behavioral disturbances occurring in dementia. Severity (1=Mild to 3=Severe) and frequency (1=occasionally to 4=very frequently) scales were recorded separately for each domain and their product gives individual domain score (range 0-12). Sum of delusions and hallucinations sub-domain scores of NPI was calculated as a measure of Alzheimer’s Disease (AD) related psychosis. Total possible score range: 0-24 with higher score indicating greater behavioral disturbances.|Week 26|Data for this outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early termination of the study.|||||
794293|NCT00905580|Secondary|Number of Patients With Hypoesthesia in the Anterior Chest at 3 Months After Operation.|we checked Hypoesthesia in the anterior chest at 3 months after operation by phone.|3 months|||participants|||Number
794831|NCT00917267|Secondary|Change in Total Cholesterol (TC) From Baseline to Week 26|Change in TC from baseline to Week 26.|Baseline, Week 26|ITT Population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.||mg/dL||Standard Error|Least Squares Mean
794270|NCT00912288|Secondary|Change From Baseline in the Neuropsychiatric Inventory (NPI) Total Score at Week 26|NPI:12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, nighttime behavior. Severity(1=Mild to 3=Severe),frequency(1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score(range 0-12). Total score=sum of each domain score(range 0-144);higher score=greater behavioral disturbances;negative change score from baseline=improvement.|Baseline, Week 26|Data for this outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early termination of the study.|||||
794271|NCT00912288|Primary|Change From Baseline in the Alzheimer’s Disease Cooperative Study – Activities of Daily Living (Severe) (ADCS-ADLsev) Score at Week 26|ADCS-ADLsev: 19-item scale measures basic and instrumental abilities in participant population and had good metric properties and reliability in detecting change. Individual score range: 0 to 5 for telephone, 0 to 4 for dressing, watch television, get around outside home, 0 to 3 for eating, walking, toilet, bathing, grooming, conversation/small talk, clear dishes, find personal belongings, obtain beverages, dispose of garbage, left on own, 0 to 1 for run water from and turn off faucet to wash hands, turn on and off light. Total score range: 0 to 54 lower scores=greater functional impairment.|Baseline, Week 26|Data for this outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early termination of the study.|||||
794272|NCT00912288|Primary|Change From Baseline in the Severe Impairment Battery (SIB) Score at Week 26|SIB developed for evaluation of cognitive function in participants, who demented to a degree that they cannot complete conventional neuropsychological testing. Test items consisted of simple, one-step commands presented with gestural cues and instructions that were repeated if necessary. SIB test consisted of 51-item scale, divided into 9 subscales: social interaction (0-6), memory (0-14), orientation (0-6), language (0-46), attention (0-6), praxis(0-8), visuospatial ability(0-8), construction(0-4), orienting to name(0-2). Total possible score:0-100; lower score = greater cognitive impairment.|Baseline, Week 26|Data for this outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early termination of the study.|||||
794273|NCT00912301|Secondary|Colonic Filling at 6 Hours|Percent of the radio-labeled meal that reached the colon at 6 hours, indirectly reflecting small bowel transit time.|after 4 days' treatment|||percentage of the radio-labeled meal||Standard Deviation|Mean
794274|NCT00912301|Secondary|Stool Consistency|"The subjects rated their stool consistency using the Bristol Stool Scale. The Bristol Stool Scale is a medical aid designed to classify the form of human feces into seven categories or types. Types 1 and 2 indicate constipation with 3 and 4 being the ideal stools especially the latter, as they are the easiest to defecate, and 5-7 tending towards diarrhea."|after 4 days' treatment|||units on a scale||Standard Deviation|Mean
794275|NCT00912301|Secondary|Ascending Colon Emptying (AC t_1/2)||after 4 days' treatment|||hours||Standard Deviation|Mean
794276|NCT00912301|Secondary|Colonic Transit at 48 Hours (GC48)|The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.|after 4 days of treatment|||units on a scale||Standard Deviation|Mean
794277|NCT00912301|Primary|Colonic Geometric Center at 24 Hours (GC24)|The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.|after 4 days of treatment|||units on a scale||Standard Deviation|Mean
794278|NCT00912405|Secondary|Number of Sinuses With Significant Post-operative Adhesion Formation|Adhesions were graded on a 5 point categorical scale with grades 3 and 4 considered clinically significant. 0=none, 1=small/non-obstructing, 2=obstructing/easily separated, 3=dense/obstructing/difficult to separate, and 4=severe/complete adhesion to lateral nasal wall.|30 days|||sinuses|Participants||Number
794279|NCT00912405|Secondary|Assessment of Changes From Baseline in Intra-ocular Pressure and Lens Opacities|Ocular safety was characterized by assessing the frequency and severity of changes from baseline in intra-ocular pressure and lens opacities. No specific pass/fail criteria we specified.|Baseline and 30 days|||Pts. w/ significant IOP elevation|||Number
794280|NCT00912405|Primary|Device Placement Success Rate|A proportion where the numerator is the number of successful device placements and denominator is the number of attempted sinuses.|At the time of procedure|||Sinuses|Participants||Number
794281|NCT00912405|Primary|Safety as Determined by the Frequency of Serious Adverse Local Tissue Response (SALT)||30 days|||Number of Sinuses|Participants|95% Confidence Interval|Number
794284|NCT00905515|Primary|Change in Risk Factors for Cardiovascular Morbidity and Chronic Graft Dysfunction as Evidenced by Blood Levels of Homocysteine and Transforming Growth Factor Beta (TGF-B)||6 months, 1 year, 2 years, 3 years||||||
794285|NCT00905515|Primary|Optimal Dose/Blood Level of Prograf in Long-term Maintenance Kidney Transplant Patients||6 months, 1 year, 2 years, 3 years||||||
794286|NCT00905515|Primary|Renal Function in Patients Converted From Cyclosporine to Prograf||6 months, 1 year, 2 years and 3 years|||Change in serum creatinine (mg/dL)||Full Range|Mean
794287|NCT00905554|Secondary|Evaluation of Pain and Tolerability Scores|Entity of pain and tolerability level on a visual analogic scale (ranging from 0 - no pain, optimal tolerability - to 100 mm - worst pain ever, unbearable)|6-9 months|||Scores on a VAS scale||Inter-Quartile Range|Median
794288|NCT00905554|Primary|Number of Patients Undergoing Complete Unsedated Colonoscopy||6-9 months|||participants|||Number
794294|NCT00905580|Primary|The Number of Participants With the Indicated Side Effects - Nausea & Vomiting, Sedation, Headache, Dizziness Etc.|Nausea and vomiting was graded on a four-point scale, where 0 = no nausea, 1 = mild nausea, 2 = severe nausea requiring antiemetics, and 3 = retching and/ or vomiting. Grades 3 and 4 were grouped together as postoperative nausea and vomiting (PONV) and rescue anti-emetic, metoclopramide 10 mg i.v. was given. We asked patients about sedation, headache, dizziness, blurred vision.|1, 6, 24 & 48 hours|||participants|||Number
794295|NCT00905580|Primary|Pain Scores (VNRS) at 1, 6, 24, 48 Hours Postoperatively.|Pain was evaluated using an 11-point verbal numerical rating scale (VNRS). Patients were instructed preoperatively to express their pain on the 0–10 VNRS, where 0 means no pain at all, and 10 represents the worst pain imaginable|1, 6, 24 & 48 hours|||VNRS||Inter-Quartile Range|Median
794296|NCT00905606|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 96 hour period|Data from all subjects who completed the study was included in the statistical analysis.||ng*hr/mL||Standard Deviation|Mean
794297|NCT00905606|Primary|AUC0-72 - Area Under the Concentration-time Curve From Time Zero to 72 Hours (Per Participant)|Bioequivalence based on AUC0-72|Blood samples collected over 96 hour period|Data from all subjects who completed the study was included in the statistical analysis.||ng*hr/mL||Standard Deviation|Mean
794298|NCT00905606|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 96 hour period|Data from all subjects who completed the study was included in the statistical analysis.||ng/mL||Standard Deviation|Mean
794299|NCT00905632|Secondary|Number of Participants With Discontinuations Due to AEs|Number of participants with adverse events (AEs) leading to discontinuation of trial drug|4 weeks|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy.||participants|||Number
794300|NCT00905632|Secondary|Number of Participants With Clinical Relevant Abnormalities for Vital Signs, Body Temperature, Physical Examination, Blood Chemistry, Haematology, Coagulation, Urinalysis and ECG|Number of participants with clinically relevant abnormalities for vital signs, blood chemistry, body temperature, physical examination, haematology, coagulation, urinalysis and electrocardiography (ECG). New abnormal findings or worsening of baseline conditions were reported as adverse events.|From the start of the study to Day 30 (2 days after last dose)|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy.||participants|||Number
794301|NCT00905632|Secondary|RA,Cmax Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose|Accumulation ratio of maximum measured concentration of the analyte in plasma (RA,Cmax): Pharmacokinetic parameters of BI 207127 and CD 6168 at steady state after the last dose. Ratio was calculated as Cmax,ss divided by Cmax.|5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy and available endpoint data at day 28. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation.||ratio||Geometric Coefficient of Variation|Geometric Mean
794302|NCT00905632|Secondary|t1/2,ss and MRTpo,ss Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose|Terminal half-life of the analyte in plasma at steady state (t1/2,ss) and mean residence time of the analyte in the body at steady state after oral administration (MRTpo,ss): Pharmacokinetic parameters of BI 207127 and CD 6168 at steady state after the last dose|5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy and available endpoint data at day 28. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation.||hour||Geometric Coefficient of Variation|Geometric Mean
794303|NCT00905632|Secondary|λz Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose|Terminal rate constant in plasma (λz): Pharmacokinetic parameters of BI 207127 and CD 6168 at steady state after the last dose|5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy and available endpoint data at day 28. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation.||1/h||Geometric Coefficient of Variation|Geometric Mean
794304|NCT00905632|Secondary|AUC0-infinity,ss Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose|Area under the concentration time curve of the analyte in plasma over the time interval of 0 to infinity at steady state (AUC0-infinity,ss): Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State (SS) After the Last Dose|5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy and available endpoint data at day 28. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
794305|NCT00905632|Secondary|C6,ss Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose|C6,ss Pharmacokinetic parameters of BI 207127 and CD 6168 at steady state after the last dose. C6,ss is the concentration 6 hours after dosing at steady-state (reported as 654 h).|654 hours after drug administration on day 28|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy and available endpoint data at day 28. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
794306|NCT00905632|Secondary|Cpre Pharmacokinetic Parameter of BI 207127 and CD 6168|Cpre,N [ng/mL] - Predose concentration of the analyte in plasma immediately before administration of the Nth dose after N-1 doses were administered for BI 207127 and CD 6168. Descriptive statistics were calculated only if at least 2/3 plasma concentrations were available. All values for Cpre,1 were not available, therefore no results are presented below.|5 minutes before drug administration on days 1, 2, 4, 8, 15, 22 and 27|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
794417|NCT00906945|Secondary|Time to Hematologic Recovery as Measured by Time to Neutrophil Recovery|-Neutrophil recovery is defined as absolute neutrophil count (ANC) >= 500/mm^3|Up to 62 days after treatment|All participants enrolled in the study (both Phase I or Phase II) who had a CR/CRi whose ANC was >=500/mm^3 were evaluable for this outcome measure.||days||Full Range|Median
794307|NCT00905632|Secondary|AUC0-6 of BI 207127 and CD 6168 in Plasma After First Dose and After Last Dose (Steady State)|Area under the concentration-time curve of the analyte in plasma (AUC) after first dose on day 1 (AUC0-6) and after last dose on day 28 (AUC0-6,ss) of BI 207127 and CD 6168|30min, 1 hour (h), 2h, 3h, 4h and 5h 55min after drug administration on day 1: 30min, 1h, 2h, 3h, 4h and 6h after admin on day 28|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
794308|NCT00905632|Secondary|Tmax of BI 207127 and CD 6168 in Plasma After First Dose and After Last Dose (Steady State)|tmax [h] Time from (last) dosing to the maximum measured concentration of the analyte in plasma after first dose on day 1 and after last dose on day 28 (steady state).|5 min before drug admin and 30min, 1 hour (h), 2h, 3h, 4h, 5h 55min, 8h, 10h, 11h 55min and 15h after drug administration on day 1: 5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation.||hour||Geometric Coefficient of Variation|Geometric Mean
794309|NCT00905632|Secondary|Cmax of BI 207127 and CD 6168 in Plasma After First Dose and After Last Dose (Steady State)|Maximum measured concentration of the analyte in plasma (Cmax) after first dose on day 1 (Cmax) and after last dose (steady state) on day 28 (Cmax,ss) of BI 207127 and CD 6168|5 min before drug admin and 30min, 1 hour (h), 2h, 3h, 4h, 5h 55min, 8h, 10h, 11h 55min and 15h after drug administration on day 1: 5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
794310|NCT00905632|Secondary|Plasma Concentration Time Profiles of CD 6168|Plasma concentration time profiles of CD 6168|0.5 hours (h), 3h, 8h, 15h, 23.917h, 503.917h, 649h, 652h, 656h and 672h after drug administration|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
794311|NCT00905632|Secondary|Plasma Concentration Time Profiles of BI 207127|Plasma concentration time profiles of BI 207127|0.5 hours (h), 3h, 8h, 15h, 23.917h, 503.917h, 649h, 652h, 656h and 672h after drug administration|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
794312|NCT00905632|Secondary|Number of Participants With Sustained Virological Response|Number of participants with sustained virological response. Sustained virological response was defined as serum HCV RNA below the limit of detection (<10 IU/mL) at least 85 days after stopping standard care (SOC).|Until end of treatment, up to 570 days|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy.||Participants|||Number
794313|NCT00905632|Secondary|Number of Participants With End of Treatment Response|Number of participants with end of treatment response (ETR) - defined as serum HCV RNA level below the limit of detection (BLD) of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) at end of treatment (including 5-day washout). Number of responders* - Response = Viral load below the limit of detection at end of all treatment.|Week 12|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy.||Participants|||Number
794314|NCT00905632|Secondary|Number of Participants With Early Virological Response|Number of participants with early virological response (EVR) defined as at least 2log10 reduction in HCV Ribonucleic acid (RNA) from baseline at Week 12. Number of responders* - Response = At least a 2 log10 reduction in viral load from baseline at Week 12 (Day 84)|Baseline and week 12|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy.||Participants|||Number
794315|NCT00905632|Secondary|Number of Participants With Rapid Virological Response|Number of participants with rapid virological response - defined as serum Hepatitis C virus (HCV) RNA level below the limit of detection (BLD) of the Roche COBAS Taqman HCV/High Pure System (HPS) for extraction assay (10 IU/mL) on Day 28.|4 weeks|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy.||Participants|||Number
794316|NCT00905632|Secondary|Number of Participants With Virologic Response at Day 28|Number of participants with virologic response at day 28, defined as achieving viral load below the limit of quantification (BLQ), <10 IU/mL, at day 28|day 28|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy.||Participants|||Number
794317|NCT00905632|Secondary|Viral Load at Each Visit up to Day 28|Viral load (VL) (original values) at each visit up to day 28.|Baseline and days 8, 15, 22 and 28|Pharmacodynamic (PD) set which included patients in the treated set but excluded VL values after recorded treatment stop time and values after subjects took wrong or additional doses of treatment. Also one patient was excluded from all descriptive PD summaries due to a protocol violation and another excluded as they did not have a predose VL value.||IU/mL||Full Range|Median
794318|NCT00905632|Secondary|Viral Load (Log10) at Each Visit up to Day 28, Change From Baseline|"Reductions of viral load (Log10) at each visit up to day 28, change from baseline. Change from baseline was calculated as the value at baseline minus the value at each later visit.
A negative value represents an increase in viral load, a positive value represents a decrease in viral load."|Baseline and days 1, 2, 4, 8, 15, 22 and 28|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy and available viral load data at baseline and day 28.||IU/mL||Full Range|Median
794319|NCT00905632|Primary|Number of Participants With Virologic Response Defined as >= 3 Log Drop in Viral Load From Baseline at Day 28 With no Evidence of Virologic Rebound During These 28 Days. Virologic Rebound is Defined as >= 1 Log Increase in Viral Load From Nadir.|The primary efficacy endpoint is the number of participants with virologic response defined as >= 3 log drop in viral load from baseline at day 28 with no evidence of virologic rebound during these 28 days. Virologic rebound is defined as >= 1 log increase in viral load from nadir.|Baseline and 4 weeks|Full Analysis Set (FAS): The subset of patients in the treated set (TS) that had at least one measurement of efficacy.||Participants|||Number
794320|NCT00905827|Secondary|Satisfaction With Training|Evaluation included 20 standard items assessing providers satisfaction with training, including items similar to other published satisfaction surveys. Survey items were rated using a five-point Likert scale indicating the degree to which respondents agreed or disagreed. Questions were always phrased positively so that agree or strongly agree is equivalent to a positive response.|post-training|||participants|||Number
794321|NCT00905827|Primary|Provider Self-efficacy and Beliefs About Suicidality|Assessed beliefs and confidence in managing suicidal individuals. Using a 5-point Likert scale, there were 11 items that addressed the following: competence, reactions, beliefs, motivations, and CAMS as it relates to their practice. Scores ranged from 11-55 with questions were phrased so higher scores indicated more positive views.|post-training|||units on a scale||Standard Error|Mean
794322|NCT00905840|Secondary|Soft Tissue and Safety Assessments|"Modified Plaque Index (mPI) and modified Sulcus Bleeding Index (mSBI) according to Mombelli at al. (1987). Assessment to be perform at four sites per implant: lingual, buccal, mesial, and distal.
mPI: 0=no plaque detected, 1=plaque only recognized by running a probe across the smooth marginal surface of the implant, 2=plaque can be seen by the naked eye, 3=abundance of soft matter.
mSBI: 0=no bleeding when a periodontal probe is passed along the gingival margin adjacent to the implant, 1=isolated bleeding spot visible, 2=blood forms a confluent red line on margin, 3=heavy or profuse bleeding.
Safety evaluations including recording of all complications, adverse events (AEs), and serious adverse events SAEs). Each AE and SAE will be assessed for severity and its potential relationship to the study device."|after 12, 24, and 36 month|"The numbers represent subjects that are classified as Yes. mPI: if all 4 evaluated scores are 0 or 1, the mPI will be classified as No. If at least one score is 2 or 3, mPI will be classified as Yes.
mSBI: if all evaluated scores are 0 or 1, mSBI will be classified as No. If at least one score is 2 or 3, mSBI will be classified as Yes."||participants|||Number
794323|NCT00905840|Secondary|Success and Survival Rate of Both Study Implants Titanium Grade IV and Titanium Zirconium) According to Definition by Buser et al. 1990|"split-mouth design
Implant success and survival rate according the definition by Buser et al. 1990 are:
Absence of persistent subjective complaints, such as pain, foreign body sensation and/or dysaesthesia
Absence of a recurrent peri-implant infection with suppuration
Absence of mobility
Absence of a continuous radiolucency around the implant
Possibility for restoration"|at 12, 24 and 36 months post surgery|The analysis was determined as Intent To Treat (ITT). The study population consisted of each randomized patient who received the device.||implants|Participants||Number
794324|NCT00905840|Primary|Change in Crestal Bone Level Between Surgery and 12 Months, to Compare Between the Titan Zircon Implant and the Titan Grade IV Implant.|"Panoramic radiographs with standardized setting were taken at the implant surgery and after 12 month. Digital images were analyzed using Image J 1.33 open software and film-based images were digitalized via a video camera, light box and an image analysis program, as described by Braegger (1998; Braegger at al. 2004). All images were analyzed by an independent investigator who was blind to the implant material.
The implant length was used as a reference measurement, and the implant chamfer 0.2 mm above the implant shoulder was used as the reference line for the bone-level measurement. Bone level was, therefore, defined as the distance from the reference point to the first bone-to-implant contact; mesial and distal bone-level changes in this region were considered as remodeling. Mesial and distal measurements were recorded and the mean of the two values was used."|12 months|The Intent To Treat (ITT) populaton consisted of all randomized patients who received implants and who underwent at least one efficacy assessment.||mm|Participants|Full Range|Mean
794325|NCT00906035|Secondary|Assess the Functional Consequences of Dipyridamole Action, Alone and in Combination With Aspirin Compared With Aspirin Alone on Local Measurements of Flow and Oxygenation. Reporting Blood Oxygenation.|Reporting blood oxygenation. Data could not be analyzed due to insufficient number of participants enrolled. Difficulty finding participants who fit into the inclusion/exclusion criteria.|Predose and dosing days 30, 90 and 180.|Data could not be analyzed due to insufficient number of participants enrolled. Data were not collected due to study termination related to the difficulty finding participants that matched the inclusion/exclusion criteria.|||||
794326|NCT00906035|Secondary|Assess the Functional Consequences of Dipyridamole Action, Alone and in Combination With Aspirin Compared With Aspirin Alone on Local Measurements of Flow and Oxygenation. Blood Flow Reporting to Added Table.|Done by doppler ultrasound. Data could not be analyzed due to insufficient number of participants enrolled. Data were not collected due to study termination related to the difficulty finding participants that matched the inclusion/exclusion criteria.|Predose and dosing days 30, 90 and 180.|Data could not be analyzed due to insufficient number of participants enrolled. Data were not collected due to study termination related to the difficulty finding participants that matched the inclusion/exclusion criteria.|||||
794327|NCT00906035|Primary|The Present Study is Designed to Explore Two Potential Mechanisms Which Have Been Linked to Dipyridamole Action on the Vessel Wall; Modulation of Vascular Eicosanoid Generation and Prevention of Oxidant Stress.|No analysis could be performed due to the insufficent number of participants enrolled. Data were not collected due to study termination related to the difficulty finding participants that matched the inclusion/exclusion criteria.|Predose and dosing days 30, 90 and 180|Data could not collected due to study termination related to the difficulty finding participants that matched the inclusion/exclusion criteria. Data could not be analyzed due to insufficient number of participants enrolled.|||||
794328|NCT00906074|Secondary|Number of Participants With Antimicrobial Resistance|Microbiological resistance reported for microorganisms that were found at a frequency greater (>) than 5 percent (%).|Day 0 (day of surgery) up to 30 days post surgery|Subset of study population with infection; N=number of participants with evaluable data||Number of participants|||Number
794329|NCT00906074|Secondary|Percentage of Participants Who Had Microbiologic Resolution of SSI (Sensitivity of Microorganisms to Antibiotics)|Resolution of SSI ranged from eradication (infection cured) to persistence (infection continued).|Day 0 (day of surgery) up to 30 days post surgery|Subset of study population with infection; N=number of participants with evaluable data||Percentage of participants|||Number
794330|NCT00906074|Secondary|Classification of SSI Infection|Participants with organ-space or deep incisional SSI.|Day 0 (day of surgery) up to 30 days post surgery|Subset of study population with infection; N=number of participants with evaluable data||participants|||Number
794418|NCT00906945|Secondary|Phase I and Phase II: Safety and Tolerability of Regimen as Measured by Grade and Frequency of Adverse Events Exceeding 10% in Total Frequency||30 days following end of treatment|||number of events|||Number
794331|NCT00906074|Secondary|ASEPSIS Classification in Participants With Serious SSI|Additional treatment, Serous discharge, Erythema, Purulent exudate, Separation of deep tissue, Isolation of bacteria, Stay in hospital prolonged over 14 days (ASEPSIS). ASEPSIS classification is a numerical indication of wound healing progress: satisfactory healing (0-10), disturbance of healing (11-20), minor wound infection (20-30), moderate wound infection (30-40), and severe wound infection (over 40).|Up to 30 days post surgery|Subset of study population with infection||participants|||Number
794332|NCT00906074|Secondary|Percentage of Participants Whose National Nosocomial Infection Surveillance System (NNISS) Scores of Preoperative Risk of Infection Were Greater Than >0|Percentage of participants with NNISS score for increased preoperative risk of infection.|Baseline (pre-surgical)|Study population||Percentage of participants|||Number
794333|NCT00906074|Primary|Percentage of Participants With Post-surgical Drainage||Day 0 (day of surgery) up to 30 days post surgery|Study Population||Percentage of participants|||Number
794334|NCT00906074|Primary|Percentage of Participants Who Showed Clinical Improvement of SSI|Clinical improvement of SSI was defined as healed (signs and symptoms of initial infection resolved) or improved (initial signs and symptoms significantly diminished without the appearance of new signs).|Day 0 (day of surgery) up to 30 days post surgery|Subset of study population with infection; N=number of participants with evaluable data||Percentage of participants|||Number
794335|NCT00906074|Primary|Percentage of Participants With Infection|Microorganism infection by bacterial type.|Day 0 (day of surgery) up to 30 days post surgery|Subset of study population with infection; N=number of participants with evaluable data||Percentage of participants|||Number
794336|NCT00906074|Primary|Type of Surgeon|Surgical speciality of physician who performed surgery.|Day 0 (day of surgery)|No data collected||surgeon|||Number
794337|NCT00906074|Primary|Percentage of Participants With Classification of Risk of Surgical Infection of Clean-contaminated, Contaminated or Dirty|Surgical infection risk class: Clean-contaminated: controlled entry in normally colonized body cavities/no unusual contamination/minimum fluid discharge/minimal sterile technique violation/re-surgery on clean surgical incision within 7 days/negative surgical exploration through intact skin. Contaminated: no acute inflammation/purulent discharge/significant fluid/material violation of sterile technique/penetrating trauma less than 4 hours old/graft in chronic skin wounds. Dirty: pus-abscess drainage/ preoperatively colonized body cavity perforated/penetrating trauma more than 4 hours old.|Day 0 (day of surgery)|Study population||Percentage of participants|||Number
794338|NCT00906074|Primary|Percentage of Participants Who Underwent Emergency Surgery or Scheduled Surgery||Day 0 (day of surgery)|Study Population||Percentage of participants|||Number
794339|NCT00906074|Primary|Percentage of Participants Who Received Pre-surgical Antibiotic Prophylaxis||Baseline (Pre-surgical)|Study Population||Percentage of participants|||Number
794340|NCT00906074|Primary|Percentage of Participants With Pre-surgical Morbidities|Morbidities (risk factors) included: neoplasm, tobacco use, body mass index (weight in kilograms divided by height in meters squared [BMI kg/m2]) greater than (>) 30, diabetes mellitus (DM), immunosuppression/ corticosteroids, anemia (hemoglobin [Hb] less than (>) 9 grams per deciliter [gr/dL]) or malnutrition (hypoalbuminemia).|Baseline (Pre-surgical)|Study population: participants with or without SSI after surgery, treated in major hospitals with general surgical units located in Spain||percentage of participants|||Number
794341|NCT00906087|Secondary|Myocilin Mutation Arg272Gly in Subjects|Number of subjects with Myocilin Arg272Gly|10 week study|Only 1 participant had a MYOC mutation in the 3 exons||Participants|||Count of Participants
794342|NCT00906087|Primary|Blood Pressure in Sitting to Supine Positions|Effect of Cosopt treatment on blood pressure changes in sitting to supine positions.|10 weeks|||mmHg||Standard Deviation|Mean
794343|NCT00906087|Primary|Intraocular Pressure in Sitting and Supine Positions.|Effect of Cosopt treatment on intraocular pressure changes in sitting to supine positions.|10 weeks|||mmHg||Standard Deviation|Mean
794344|NCT00906178|Secondary|Unprotected Sex at Three-month Follow-up|Ever had vaginal or anal sex without a condom in the past 90 days|3 months post-intervention|ITT--Intention to Treat||participants|||Number
794345|NCT00906178|Secondary|Abstinence at Three-month Follow-up|Sexual abstinence (i.e., not having vaginal or anal sex) in the past 90 days|3 months post-intervention|ITT--Intention to Treat||participants|||Number
794346|NCT00906178|Primary|Sexual Abstinence|Not having had vaginal or anal sex in the past three months|6-months post-intervention|ITT - Intention to Treat||participants|||Number
794347|NCT00906178|Primary|Sex Without a Condom as Assessed by Self-report|Unprotected sex (i.e., vaginal or anal sex without a condom) in the past three months|6-months post-intervention|ITT - Intention to Treat||participants|||Number
794348|NCT00906204|Secondary|Kidney Function|Estimated Glomerular Filtration Rate using the abbreviated MDRD formula (Modification of Diet in Renal Disease study)|12 months post-transplantation|||mL/min/1.73m^2||Standard Deviation|Mean
794349|NCT00906204|Secondary|Incomplete Thymoglobulin Infusion||First 7 days post-transplantation|||participants|||Number
794350|NCT00906204|Secondary|Acute Kidney Rejection|Kaplan-Meier probability estimates of rejection rates|12 months post-transplantation|||participants|||Number
794351|NCT00906204|Secondary|Graft Survival|Kaplan-Meier estimates of graft survival probability for 12 months after transplantation|12 months post-transplantation|||participants|||Number
794352|NCT00906204|Secondary|Patient Survival|Kaplan-Meier estimate of the number of patients who survived for the 12 months after kidney transplantation.|12 months post-transplantation|||participants|||Number
794353|NCT00906204|Primary|Composite Endpoint of 5 Components: Fever, Hypoxia, Hypotension, Cardiac Events, and Delayed Graft Function|"The composite endpoint components and definitions are:
Fever: Body temperature ≥ 38.5˚C.
Hypotension: After rATG initiation, systolic blood pressure ≤ 90 mmHg requiring de novo treatment with vasopressors.
Hypoxia: During transplantation surgery, increase in FiO2 to ≥ 60% following rATG initiation. Following transplantation, starting in recovery room, FiO2 ≥ 50% or nasal cannula delivering ≥ 3 liters, either singly or combined, for > 12 hours out of a 24 hour period.
Cardiac events: Myocardial Infarction, clinically significant dysrhythmia (atrial fibrillation, atrial flutter, ventricular fibrillation and ventricular tachycardia)
Delayed graft function (DGF): Requirement for dialysis within 7 days of transplantation"|During first 7 days after kidney transplantation|||participants|||Number
794500|NCT00913003|Secondary|Number of Participants Experiencing Post Operative Ileus||7 days|||Participants|||Number
794354|NCT00906243|Primary|Phase I: Assessment of Safety and Tolerability of the Trial Regimen|"Dose Limiting Toxicity (DLT) is defined as the following treatment-related adverse events or laboratory abnormalities, graded according to NCI-CTCAE version 3.0:
All Categories equal or greater than grade 3
Allergy/autoimmunity equal or greater than grade 2
Dosing delay greater than 48 hours due to toxicity All adverse events will be graded and documented according to Common Terminology Criteria for Adverse Events version 3.0."|At Nine Weeks with Follow Up at One Year|Phase 1 consisted of cohort 1 with 3 subjects and cohort 2 with three subjects.||events|||Number
794355|NCT00906282|Secondary|Complete Resection Rate|The percent of patients who had surgical resection listed by procedure type: lobectomy or pneumonectomy, or resection of adjacent chest wall or mediastinal structures when appropriate. Surgery followed standard guidelines for resection of non-small-cell lung cancer (NSCLC).|At weeks 15-18|||percentage of patients|||Number
794356|NCT00906282|Secondary|Rate of Residual Disease as an Assessment of Pathological Partial Response (pPR)|pPR was further assessed by the amount of residual tumor measured at surgery: microscopic residual disease = less than 1 centimeter (<1 cm); macroscopic residual disease = 1 centimeter or greater (≥1 cm).|At 15-18 weeks|The amount of residual tumor measured in centimeters (cm).||centimeters||Full Range|Median
794357|NCT00906282|Secondary|Pathologic Response Rate|Percent of patients having a pathological complete or partial response (pCR or pPR) at surgery. pCR defined as complete removal of all tumor. pPR defined as residual viable tumor demonstrated in the resected specimen.|weeks 15 -18|||percentage of participants|||Number
794358|NCT00906282|Secondary|Objective Tumor Response|Objective Tumor Response defined as the percent of patients who completed up to 4 cycles of pre-operative chemotherapy and achieved a complete response (CR) or partial response (PR) assessed by Response Evaluation in Solid Tumors (RECIST) 1.0. Patients with stable disease (SD) or response to treatment were deemed surgical candidates. [CR=disappearance of all target tumors; PR= ≥30% decrease in the sum of the longest diameters of target tumors. SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.]|At 6 and 12 weeks|||percentage of participants|||Number
794359|NCT00906282|Primary|3-Year Overall Survival Rate|The percentage of patients who were alive at 3 years from time of first study treatment until date of death from any cause. Overall survival is shown for the Intent-to-Treat population.|36 months|||percentage of participants||95% Confidence Interval|Number
794360|NCT00906347|Secondary|Time Elapsed From Start of Labor Augmentation to Delivery||Initiation of augmentation until delivery|Intent to treat||minutes||Inter-Quartile Range|Median
794361|NCT00906347|Secondary|Method of Delivery||At delivery|Intent to treat||participants|||Number
794362|NCT00906347|Secondary|Maternal Hypovolemia Requiring Blood Transfusion||Until hospital discharge|Intent to treat||participants|||Number
794363|NCT00906347|Secondary|Maternal Chorioamnionitis|Temperature 38 degrees C or higher in the absence of other sources of infection|During labor|Intent to treat||participants|||Number
794364|NCT00906347|Secondary|Admission of Neonatal Intensive Care Unit||Until hospital discharge|Intent to treat||infants|||Number
794365|NCT00906347|Secondary|Umbilical Cord Artery pH <7.1||Obtained at delivery|Intent to treat||infants|||Number
794366|NCT00906347|Secondary|Infant Apgar Score <4|Assigned on a scale of 0-10 by pediatric provider attending delivery. A lower score reflects need for further resuscitation and is potentially associated with increased risk of adverse neurological outcomes.|5 minutes after delivery|Intent to treat||infants|||Number
794367|NCT00906347|Primary|Uterine Tachysystole|Defined as six contractions in two consecutive 10-minute periods|Up to four hours after administration of study drug|Intent to treat||participants|||Number
794368|NCT00906399|Secondary|Estimated Proportion of Participants With Sustained Disability Progression at 1 Year|Sustained disability progression is defined as: at least a 1.0 point increase on the EDSS from baseline EDSS ≥ 1.0 that is sustained for 12 weeks, or at least a 1.5 point increase on the EDSS from baseline EDSS = 0 that is sustained for 12 weeks. The EDSS measures the disability status of people with MS on a scale that ranges from 0 to 10. The range of main categories include 0 (normal neurologic examination), to 5 (ambulatory without aid or rest for 200 meters/disability severe enough to impair full daily activities), to 10 (death due to MS). Estimated proportion of participants with progression based on the Kaplan-Meier product limit method.|1 Year|ITT population: participants who were randomized and received at least 1 dose of study treatment (peginterferon beta-1a or placebo). Participants were censored at the time of withdrawal/switch if they withdrew from study or switched to alternative MS medication without a progression.||proportion of participants|||Number
794369|NCT00906399|Secondary|Proportion of Participants Relapsed at 1 Year|A relapse is defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting for at least 24 hours, and accompanied by new objective neurologic findings. Only relapses confirmed by INEC were included in the analysis. Estimated proportion of participants relapsed is based on the Kaplan-Meier product limit method.|Year 1|ITT population: participants who were randomized and received at least 1 dose of study treatment (peginterferon beta-1a or placebo). Participants who did not experience a relapse prior to switching to alternative MS medications or withdrew from study were censored at the time of switch/withdrawal.||proportion of participants|||Number
794370|NCT00906399|Secondary|Number of New Or Newly Enlarging T2 Hyperintense Lesions at 1 Year|Number of new or newly enlarging T2 hyperintense lesions on brain magnetic resonance imaging (MRI) scans. Data observed after participants switched to alternative MS medications are excluded. Adjusted mean is based on negative binomial regression, adjusted for baseline number of T2 lesions.|1 Year|ITT population, with at least 1 post-baseline assessment. Missing data prior to alternative MS medications and visits after participants switched to alternative MS medications imputed based on previous visit data assuming the constant rate of lesion development or group mean at same visit.||lesions||95% Confidence Interval|Mean
794385|NCT00906698|Secondary|Maximum Measured Concentration of Afatinib After Multiple Administrations of 40mg Afatinib in Presence and Absence of 25mg/m^2 i.v. Vinorelbine at Steady State||0.05 hours (h) before dosing at day 1 and 0.10h, 0.30h, 1h, 4h, 7h, 24h and 168h after dosing, 0.05 hours (h) before dosing at day 15 and day 21 and 0.10h, 0.30h, 1h, 2h, 3h, 4h, 6h, 7h and 24h after dosing|All patients treated in the MTD cohort, for which evaluable PK parameters were available for the analysis.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
794371|NCT00906399|Primary|Annualized Relapse Rate (ARR) at 1 Year|A relapse is defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting for at least 24 hours, and accompanied by new objective neurologic findings. Only relapses confirmed by an independent neurology evaluation committee (INEC) are included in the analysis. Data after participants switched to alternative multiple sclerosis (MS) medications are excluded. Data were analyzed using negative binomial regression, adjusted for baseline Expanded Disability Status Scale (EDSS) score (< 4 versus ≥ 4), baseline age (< 40 versus ≥ 40 years), and baseline relapse rate (number of relapses in 3 years prior to study entry divided by 3).|1 Year|Intent-to-treat (ITT) population: participants who were randomized and received at least 1 dose of study treatment (peginterferon beta-1a or placebo).||relapses per person-years||95% Confidence Interval|Number
794372|NCT00906425|Secondary|Implant Survival Rate|The percentage of implants that remain in place in the jaw.|12 months|||% of implants|||Number
794373|NCT00906425|Secondary|Implant Survival Rate|The percentage of implants that remain in place in the jaw.|6 months|||% of implants|||Number
794374|NCT00906425|Primary|Mean Change in Bone Level (Distance B) After 6 Months Compared to Baseline (=Surgery)|The primary aim is to measure the bone level change between mesial and distal aspects of the implant at 6 months post implantation. The reference point for the bone level measurement is the implant shoulder.|Baseline and 6 months|ITT population||millimeters||Standard Deviation|Mean
794375|NCT00906503|Primary|Feasibility of Ultra Short-term Steroid Therapy to Increase the Accuracy of FDG-PET/CT Imaging|The blood glucose of all patients will be checked by accu-check before the injection of 18F-FDG. The acceptable blood glucose level will be ≤120 mg/dl. Any participant experienced elevated fasting blood glucose of more than 120 mg/dl after steroid therapy, he /she will be asked to come back to the PET center within 48 hours to check the blood glucose level. If the blood glucose level did not decline to baseline level, the participant will be asked to follow with his/her family doctor for management. Participants with history of systemic hypertension will be monitored for increased blood pressure. After 50-to-70 minutes period for FDG incorporation into presumed lesions, patient will under go a limited 18F-FDG PET/CT for the area of the interest (1-2 bed positions). PET imaging will be performed using a GE Discovery STE PET/CT system (GE Medical Systems, Milwaukee, WI).|24-48 hours|||gm/ml||Standard Deviation|Mean
794376|NCT00906698|Secondary|Time From Dosing to the Maximum Concentration of Vinorelbine After Single and Multiple Administrations of 60mg/m^2 Vinorelbine Per os in Presence and Absence of Afatinib at Steady State||0.05 hours (h) before dosing at day 1 and 1h, 1.30h, 2h, 3h, 6h, 7h and 24h after dosing|All patients treated in the TS, for which evaluable PK parameters were available for the analysis.||hours||Full Range|Median
794377|NCT00906698|Secondary|Time From Dosing to the Maximum Concentration of Afatinib After Multiple Administrations of 40mg Afatinib in Presence and Absence of 60mg/m^2 Per os Vinorelbine at Steady State||0.05 hours (h) before dosing at day 1 and 1h, 1.30h, 2h, 3h, 6h, 7h and 24h after dosing|All patients treated in the MTD cohort, for which evaluable PK parameters were available for the analysis.||hours||Full Range|Median
794378|NCT00906698|Secondary|Maximum Measured Concentration of Vinorelbine After Multiple Administrations Per os of 60mg/m^2 in Presence and Absence of Afatinib at Steady State||0.05 hours (h) before dosing at day 1 and 0.10h, 0.30h, 1h, 4h, 7h, 24h and 168h after dosing, 0.05 hours (h) before dosing at day 15 and day 21 and 0.10h, 0.30h, 1h, 2h, 3h, 4h, 6h, 7h and 24h after dosing|All patients treated in the TS, for which evaluable PK parameters were available for the analysis.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
794379|NCT00906698|Secondary|Maximum Measured Concentration of Afatinib After Multiple Administrations of 40mg Afatinib in Presence and Absence of 25mg/m^2 Per os Vinorelbine at Steady State||0.05 hours (h) before dosing at day 1 and 1h, 1.30h, 2h, 3h, 6h, 7h and 24h after dosing|All patients treated in the MTD cohort, for which evaluable PK parameters were available for the analysis.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
794380|NCT00906698|Secondary|Area Under the Concentration-time Curve of Vinorelbine After Multiple Administrations Per os of 60mg/m^2 Vinorelbine in Presence and Absence of Afatinib at Steady State||0.05 hours (h) before dosing at day 1 and 1h, 1.30h, 2h, 3h, 6h, 7h and 24h after dosing|All patients treated in the TS, for which evaluable PK parameters were available for the analysis.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
794381|NCT00906698|Secondary|Area Under the Concentration-time Curve of Afatinib After Multiple Administrations of 40mg Afatinib in Presence and Absence of 60mg/m^2 Per os Vinorelbine at Steady State||0.05 hours (h) before dosing at day 1 and 1h, 1.30h, 2h, 3h, 6h,, 7h and 24h after dosing|All patients treated in the MTD cohort, for which evaluable PK parameters were available for the analysis.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
794382|NCT00906698|Secondary|Time From Dosing to the Maximum Concentration of Vinorelbine After Single and Multiple Intravenous Administrations of 25mg/m^2 Vinorelbine in Presence and Absence of Afatinib at Steady State||0.05 hours (h) before dosing at day 1 and 0.10h, 0.30h, 1h, 4h, 7h, 24h and 168h after dosing, 0.05 hours (h) before dosing at day 15 and day 21 and 0.10h, 0.30h, 1h, 2h, 3h, 4h, 6h, 7h and 24h after dosing|All patients treated in the TS, for which evaluable PK parameters were available for the analysis.||hours||Full Range|Median
794383|NCT00906698|Secondary|Time From Dosing to the Maximum Concentration of Afatinib After Multiple Administrations of 40mg Afatinib in Presence and Absence of 25mg/m^2 i.v. Vinorelbine at Steady State||0.05 hours (h) before dosing at day 1 and 0.10h, 0.30h, 1h, 4h, 7h, 24h and 168h after dosing, 0.05 hours (h) before dosing at day 15 and day 21 and 0.10h, 0.30h, 1h, 2h, 3h, 4h, 6h, 7h and 24h after dosing|All patients treated in the MTD cohort, for which evaluable PK parameters were available for the analysis.||hours||Full Range|Median
794384|NCT00906698|Secondary|Maximum Measured Concentration of Vinorelbine After Single and Multiple Intravenous Administrations of 25 mg/m^2 Vinorelbine in Presence and Absence of Afatinib at Steady State||0.05 hours (h) before dosing at day 1 and 0.10h, 0.30h, 1h, 4h, 7h, 24h and 168h after dosing, 0.05 hours (h) before dosing at day 15 and day 21 and 0.10h, 0.30h, 1h, 2h, 3h, 4h, 6h, 7h and 24h after dosing|All patients treated in the TS, for which evaluable PK parameters were available for the analysis.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
794416|NCT00906945|Secondary|Time to Hematologic Recovery as Measured by Time to Neutrophil Recovery|-Neutrophil recovery is defined as absolute neutrophil count >= 1000/mm^3|Up to 62 days after treatment|All participants enrolled in the study (both Phase I or Phase II) who had a CR/CRi whose ANC was >=1000/mm^3 were evaluable for this outcome measure.||days||Full Range|Median
794386|NCT00906698|Secondary|Area Under the Concentration-time Curve of Vinorelbine After Single and Multiple Intravenous Administrations of 25mg/m^2 Vinorelbine in Presence and Absence of Afatinib at Steady State||0.05 hours (h) before dosing at day 1 and 0.10h, 0.30h, 1h, 4h, 7h, 24h and 168h after dosing, 0.05 hours (h) before dosing at day 15 and day 21 and 0.10h, 0.30h, 1h, 2h, 3h, 4h, 6h, 7h and 24h after dosing|All patients treated in the TS, for which evaluable PK parameters were available for the analysis.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
794387|NCT00906698|Secondary|Area Under the Concentration-time Curve of Afatinib After Multiple Administrations of 40mg Afatinib in Presence and Absence of 25mg/m^2 i.v. Vinorelbine at Steady State||0.05 hours (h) before dosing at day 1 and 0.10h, 0.30h, 1h, 4h, 7h, 24h and 168h after dosing, 0.05 hours (h) before dosing at day 15 and day 21 and 0.10h, 0.30h, 1h, 2h, 3h, 4h, 6h, 7h and 24h after dosing|All patients treated in the MTD cohort, for which evaluable PK parameters were available for the analysis.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
794388|NCT00906698|Secondary|Progression-free Survival (PFS)|PFS was defined as the time from the first dose of study medication to the occurrence of tumour progression or death, whichever came first. It was assessed according to RECIST 1.0. Median time results from unstratified Kaplan-Meier estimates.|From first dose of study medication to the occurrence of progression or death whichever came first, up to 44 months.|All patients treated in the MTD cohorts.||weeks||Inter-Quartile Range|Median
794389|NCT00906698|Secondary|Best Percentage Change in Tumour Size|Best percentage change in tumour size was the best percentage change in the sum of diameters of target lesions and was calculated as (minimum sum of diameters post baseline - sum of diameters at baseline)/sum of diameters at baseline. Negative values indicate a decrease, positive values an increase.|Screening and every 8 weeks after starting of treatment, up to 44 weeks.|Patients from Treated Set (TS).||percentage change in tumour size||Standard Error|Mean
794390|NCT00906698|Secondary|Duration of Disease Control|Duration of disease control was measured from the start of study treatment to the time of progression or death, whichever occured first.|From first dose of study medication to response measurement, up to 44 months. Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.|Patients from Treated Set (TS) with disease control.||days||Full Range|Median
794391|NCT00906698|Secondary|Duration of Objective Response|The duration of objective response was measured from the time of first documented confirmed CR or PR to the time of progressive disease or death, whichever occured earlier.|From first dose of study medication to response measurement, up to 44 months. Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.|Patients from Treated Set (TS) with Objective Response.||days||Full Range|Median
794392|NCT00906698|Secondary|Time to Objective Response|The time to OR was the duration from the first treatment to the time when the measurement criteria for first documented confirmed CR and/or PR were met according to RECIST 1.0 criteria.|From first dose of study medication to response measurement, up to 44 months. Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.|Patients from the Treated Set (TS) with objective response.||days||Full Range|Median
794393|NCT00906698|Secondary|Number of Patients With Disease Control (DC)|DC is defined as confirmed complete response (CR), partial response (PR) and stable disease (SD) and was assessed according to Response Evaluation Criteria in Solid Tumours (RECIST 1.0).|From first dose of study medication to response measurement, up to 44 months. Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.|All patients from the Treated Set (TS).||participants|||Number
794394|NCT00906698|Secondary|Number of Patients With Objective Response (OR)|OR is defined as confirmed complete response and confirmed partial response (PR) and was assessed according to Response Evaluation Criteria in Solid Tumours (RECIST 1.0).|From first dose of study medication to response measurement, up to 44 months. Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.|All patients from the Treated Set (TS).||participants|||Number
794395|NCT00906698|Secondary|Number of Patients With Best Overall Response|Overall response is defined as complete response, partial response and stable disease and was assessed according to Response Evaluation Criteria in Solid Tumours (RECIST 1.0). Complete response (CR) and partial response (PR) had to be confirmed by a subsequent tumour assessment at least 28 days after the criteria for CR or PR were first met. To confirm a status of stable disease, the duration of stable disease was to be at least 42 days.|From first dose of study medication to response measurement, up to 44 months. Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.|All patients from the Treated Set (TS).||participants|||Number
794396|NCT00906698|Primary|Number of Participants With Dose-limiting Toxicities (DLT)|Number of participants with DLT for the determination of the Maximum Tolerated Dose (MTD). 3+3 dose escalation design. MTD based on DLTs during first treatment course. After MTD was determined, additional patients were included at the MTD in an expansion cohort.|28 days|Treated Set (TS). TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.||participants|||Number
794397|NCT00906776|Secondary|Change in Distance Between the Cementum-enamel-junction and the Base of the Vertical Bone Defect||Baseline and 12 months|||mm||Standard Deviation|Mean
794398|NCT00906776|Secondary|Change in Probing Pocket Depth (PPD)|PPD is measured using a periodontal probe from the gingival margin to the bottom of the pocket.|Baseline and 6 months|||mm||Standard Deviation|Mean
794399|NCT00906776|Secondary|Change in Clinical Attachment Level (CAL)|CAL is calculated as the sum of Probing Pocket Depth (PPD) and Recession (REC). PPD is measured using a periodontal probe from the gingival margin to the bottom of the pocket. REC is measured using a periodontal probe from the gingival margin to the cemento-enamel junction (CEJ).|Baseline and 6 months|||mm||Standard Deviation|Mean
794400|NCT00906776|Secondary|Change in Probing Pocket Depth (PPD)|PPD is measured using a periodontal probe from the gingival margin to the bottom of the pocket.|Baseline and 12 months|||millimeters||Standard Deviation|Mean
794401|NCT00906776|Secondary|Change in Distance Between the Cementum-enamel-junction and the Base of the Vertical Bone Defect||Baseline and 6 months|||mm||Standard Deviation|Mean
794402|NCT00906776|Primary|Change in Clinical Attachment Level (CAL)|CAL is calculated as the sum of Probing Pocket Depth (PPD) and Recession (REC). PPD is measured using a periodontal probe from the gingival margin to the bottom of the pocket. REC is measured using a periodontal probe from the gingival margin to the cemento-enamel junction (CEJ).|Baseline and 12 months|||millimeters||Standard Deviation|Mean
794403|NCT00906789|Secondary|Sensitivity and Specificity Using SoftView Software|Sensitivity and specificity were calculated using the radiologists' responses of recommendations for follow-up with CT or biopsy. Truth was whether or not the nodule identified was found to be cancer. Sensitivity is the percentage of correct identification of a positive case (a case with cancer). Specificity is the percentage of negative cases (those without cancer) that were correctly identified as not having cancer. The mean values of 15 radiologists are used.|Three days of experiment over 3-5 months, varied by participant|||percentage of cases||95% Confidence Interval|Mean
794404|NCT00906789|Other Pre-specified|Difference in the Area Under the LROC Curve Comparing OnGuard 1.0 and OnGuard 5.1|This reports the comparison of the detection of lung nodules that were proven to represent lung cancers. It compares the results of two versions of computer-aided detection software: OnGuard 1.0 from 2001 and OnGuard 5.1 from 2009. The results represent the responses of radiologists when they use one or the other types of software. To compare radiologists' results with the two types of software, the measurement analyzed was the difference in the areas under the localized receiver operating characteristic curve (LROC). The results from the 15 participating radiologists were averaged (mean value). The area under the LROC curve is a measure of the trade-offs between sensitivity and 1-specificity that occurs as the level of certainty of a positive finding changes. It is normally reported as a decimal without units. In this study dsign, a lower number indicates that the new method (OnGuard 5.1), if statistically significant, if better.|5 months|81 of the 263 radiographs contained a non-calcified nodule that had been diagnosed as lung cancer. Power calculation showed 246 patients, in a 2:1 ratio of nodule absent to present would provide 80% power to detect a difference in areas under the curve of 0.10 or greater.||unitless|Participants|95% Confidence Interval|Mean
794405|NCT00906789|Primary|Improvement in Cancer Detection as Measured by Localized Receiver Operating Characteristic) LROC Changes Under the LROC Curve.|"Standard methods for LROC methodology and statistical analysis were used. We are testing two different types of software using different cases, but the same radiologists to control for radiologist differences. LROC is Localized Receiver Operating Characteristic. LROC measures the trade-offs between sensitivity and specificity as radiologists use different levels of suspicion of disease. This analysis is for the software that decreases the visibility of the ribs and clavicles while preserving (and potentially enhancing) the visibility of the lungs and lung diseases. In this case, the level of suspicion recorded was for the radiologist's concern that a finding did or did not represent cancer. Please note that the FDA approved indications for use is to detected nodules that may represent cancer, but in our study scoring for a true finding was based on whether or not the nodule did represent cancer.
A larger number, if statistically significant, indicates that that method is better."|Three days of experiment over 3-5 months, varied by participant|122 subjects had cancer that potentially could be detected on their chest radiograph. Power analysis showed that sample size of 351 patients, in a 2:1 ratio of nodule absent to present patients was selected to provide 80% power to detect a difference in areas under the curve of 0.10 or greater.||unitless|Participants|95% Confidence Interval|Mean
794406|NCT00906945|Post-Hoc|Relapse Free-survival Rate||2 years|All participants enrolled in the study (both Phase I or Phase II) who had a CR/CRi were evaluable for this outcome measure.||percentage of participants|||Number
794407|NCT00906945|Secondary|Overall Survival|Overall survival: Defined as the date of first dose of study drug to the date of death from any cause.|Median follow-up was 34.6 months|||days||Full Range|Median
794408|NCT00906945|Secondary|Time to Treatment Failure||8 days|Data was not collected for this outcome measure. It is not well defined in the literature as when to measure treatment failure. Relapse free survival is a better way to measure response duration (this outcome measure was added to the results).|||||
794409|NCT00906945|Secondary|Time to Progression|Recurrence / morphologic relapse: Defined as reappearance of blasts in the blood or the finding of > 5% blasts in the BM, not attributable to any other cause. New dysplastic changes are considered a relapse. If there are no blasts in the peripheral blood and 5-19% blasts in the BM, the BM biopsy and aspirate should be repeated in > 1 week to confirm relapse.|2 years|Data was not collected for this outcome measure. Progression is very hard to define acute myeloid leukemia and including it as a pre-specified secondary outcome measure in the protocol was an oversight.|||||
794410|NCT00906945|Secondary|Characterize the Effects of Plerixafor Plus G-CSF on Fold Change in CXCR4 Clone 12G5 Relative Mean Fluorescent Intensity||6 hours after plerixafor|29 patients were evaluable for this outcome measure (3 patients were never treated due to being ineligible and 1 patient never treated due to physician decision). The remaining 6 patients did not have usable peripheral blood samples for this outcome measure.||fold change in CXCR4 clone 1D9||Standard Deviation|Mean
794411|NCT00906945|Secondary|Characterize the Effects of Plerixafor Plus G-CSF on Fold Change in CXCR4 Clone 1D9 Relative Mean Fluorescent Intensity||6 hours after plerixafor|29 patients were evaluable for this outcome measure (3 patients were never treated due to being ineligible and 1 patient never treated due to physician decision). The remaining 6 patients did not have usable peripheral blood samples for this outcome measure.||fold change in CXCR4 clone 1D9||Standard Deviation|Mean
794412|NCT00906945|Secondary|Characterize the Mobilization of Leukemic Cells With Plerixafor Plus G-CSF as Measured by Fold Change in AML Blast Count||6 hours after plerixafor|31 patients were evaluable for this outcome measure (3 patients were never treated due to being ineligible and 1 patient never treated due to physician decision). The remaining 4 patients did not have usable peripheral blood samples for this outcome measure.||fold change in AML blast count||Standard Deviation|Mean
794413|NCT00906945|Secondary|Characterize the Mobilization of Leukemic Cells With Plerixafor Plus G-CSF as Measured by Fold Change in White Blood Cells||6 hours after plerixafor|31 patients were evaluable for this outcome measure (3 patients were never treated due to being ineligible and 1 patient never treated due to physician decision). The remaining 4 patients did not have usable peripheral blood samples for this outcome measure.||fold change in white blood cells||Standard Deviation|Mean
794414|NCT00906945|Secondary|Time to Hematologic Recovery as Measured by Time to Platelet Recovery|-Platelet recovery is defined as platelets >= 100,000/mm3|Up to 62 days after treatment|All participants enrolled in the study (both Phase I or Phase II) who had a CR whose platelets were >=100,000/mm^3 were evaluable for this outcome measure.||days||Full Range|Median
794415|NCT00906945|Secondary|Time to Hematologic Recovery as Measured by Time to Platelet Recovery|-Platelet recovery is defined as platelets >= 50,000/mm^3|Up to 62 days after treatment|All participants enrolled in the study (both Phase I or Phase II) who had CR whose platelets were >=50,000/mm^3 were evaluable for this outcome measure.||days||Full Range|Median
794419|NCT00906945|Primary|Phase II: Complete Response Rate (CR+CRi)|"Morphologic complete remission (CR): Defined as morphologic leukemia-free state, including <5% blasts in BM aspirate with marrow spicules and a count of > 200 nucleated cells and no blasts with Auer rods, no persistent extramedullary disease, ANC > 1,000/mm3, platelet count > 100,000/mm3.
Morphologic complete remission with incomplete blood count recovery (CRi): Defined as CR with the exception of neutropenia <1,000/mm3 or thrombocytopenia <100,000/mm3."|45 days|Only patients enrolled in Phase 2 portion were analyzed for this outcome measure.||percentage of participants|||Number
794420|NCT00906945|Primary|Phase I: Maximum Tolerated Dose of Plerixafor Plus G-CSF When Combined With MEC||Completion of Phase I enrollment (17 months)|Number of participants analyzed is the number of participants enrolled in the Phase I portion of the study.||mcg/kg/day|||Number
794421|NCT00906971|Primary|Retentive Fecal Incontinence.|"Retentive fecal incontinence is the lose of fecal while the patient tries to avoid the bowel movement.
The patients (or their parents) received a bowel diary and they fulfilled about frequency of episodes of retentive fecal incontinence weekly."|six weeks|||days/week||Standard Deviation|Mean
794422|NCT00906971|Primary|Frequency of Defecation.|The patients (or their parents) received a bowel diary and they fulfilled about frequency of defecation weekly.|six weeks|||days/week||Standard Deviation|Mean
794423|NCT00907088|Secondary|IDA (Hemoglobin < 110 g/L With Iron Deficiency)||Age 24 months||||||
794424|NCT00907088|Secondary|Iron Deficiency (Defined as Serum Ferritin <10 mcg/L and MCV < 70 mcm3 Iron Deficiency.||Age 24 months||||||
794425|NCT00907088|Primary|The Primary Outcome is Iron Depletion, and Will be Defined as Serum Ferritin <10 mcg/L.||Age 24 months|||participants|||Number
794426|NCT00907101|Secondary|Worst Post Baseline Tolerability Assessment - Stinging/Burning|Please note: Tolerability assessments were recorded separately from adverse events. Tolerability changes which may have required a temporary or permanent interruption of the subject’s participation in the study (at his/her request or at the investigator’s discretion), or concomitant treatment, was to be recorded in the AE form of the CRF. An entry was to be made on the AE form for all AEs.|Week 4|||participants|||Number
794427|NCT00907101|Secondary|Worst Post Baseline Tolerability Assessment - Scaling|Please note: Tolerability assessments were recorded separately from adverse events. Tolerability changes which may have required a temporary or permanent interruption of the subject’s participation in the study (at his/her request or at the investigator’s discretion), or concomitant treatment, was to be recorded in the AE form of the CRF. An entry was to be made on the AE form for all AEs.|Week 4|||participants|||Number
794428|NCT00907101|Secondary|Worst Post Baseline Tolerability Assessment - Dryness|Please note: Tolerability assessments were recorded separately from adverse events. Tolerability changes which may have required a temporary or permanent interruption of the subject’s participation in the study (at his/her request or at the investigator’s discretion), or concomitant treatment, was to be recorded in the AE form of the CRF. An entry was to be made on the AE form for all AEs.|Week 4|||participants|||Number
794429|NCT00907101|Secondary|Worst Post Baseline Tolerability Assessment - Erythema|Please note: Tolerability assessments were recorded separately from adverse events. Tolerability changes which may have required a temporary or permanent interruption of the subject’s participation in the study (at his/her request or at the investigator’s discretion), or concomitant treatment, was to be recorded in the AE form of the CRF. An entry was to be made on the AE form for all AEs.|Week 4|||participants|||Number
794430|NCT00907101|Primary|Change From Baseline in Quantitative Bacteriology Measurements at Week 4|Mean log10 values of P. acnes from swabbed skin samples Please note: Quantitative bacteriologic cultures were obtained from the facial skin (forehead) at screening, baseline, week 2 and week 4/early termination. Samples were obtained according to a modification of the technique of Williamson and Kligman. CFUs of P. acnes were counted at the dilution that contained between 10 and 100 CFUs. Total densities of P. acnes were calculated and reported as the average (of both plates) of the log10 CFUs per cm².|Week 4|||log10 CFU/cm2||Standard Deviation|Mean
794438|NCT00907257|Secondary|Measurement of Success|"Number of subjects achieving success according to dichotomized Investigator Global Assessment (IGA) using criteria of grades 0 or 1, or improvement of 2 grades from baseline score. Possible grades from 0-6 are described as follows:
0 = Clear, 1=Almost Clear, 2=Mild, 3=Mild to Moderate, 4=Moderate, 5=Moderately Severe, 6=Severe."|Baseline to Week 12|Intention to Treat (ITT)population and imputation technique of Last Observations Carried Forward (LOCF)||Participants|||Number
794439|NCT00907257|Secondary|Change From Baseline in Inflammatory and Non-Inflammatory Lesion Counts and Their Totals|Between group comparison with Last Count Carried Forward (LOCF) of Inflammatory Facial Acne Lesion Count (the sum of papules and pustules), Non-Inflammatory Facial Acne Lesion Count (the sum of open and closed comedones), and their Total (the sum of Non-inflammatory and Inflammatory lesions).|Baseline to Week 12|Data set includes all Intent to Treat (ITT)subjects. Imputation technique was Last Observation Carried Forward (LOCF).||Lesions||Standard Error|Least Squares Mean
794440|NCT00907257|Primary|Change From Baseline in Total Facial Acne Lesion Count|Total Facial Acne Lesion Count is the sum of non-inflammatory and inflammatory lesions, plus nodules/cysts. Change from Baseline is calculated as the value after Baseline minus the baseline value, and negative values indicate improvement.|Baseline to Week 12|Per Protocol Population, which includes all Intention to Treat (ITT) subjects who completed the 12 weeks of treatment and evaluations with no major protocol deviations.||Lesions||Standard Error|Least Squares Mean
794441|NCT00912743|Secondary|Overall Survival|Overall survival is defined as the duration from first dose till death from any cause. In absence of death, the time is calculated from first dose till the date subject last known to be alive|Survival follow-up from first dose till death of the patient or till end of study in absence of death, assessed up to 35 months|Full analysis set - all treated patients||days||95% Confidence Interval|Median
794442|NCT00912743|Secondary|Progression Free Survival|Progression free survival is defined as the duration from first dose till objective progression or death. In absence of progression or death, the time is calculated from first dose till last evaluable scanning visit.|From baseline, i.e. up to 28 days before first study drug dose, and then every 2 cycles (8 weeks) up to objective disease progression by RECIST, assessed up to 35 months|Full analysis set - all treated patients||days||95% Confidence Interval|Median
794443|NCT00912743|Primary|Tumour Response|Tumour response is the number of patients who experienced complete or partial response at least once during the assessment period, according to the definitions of Response Evaluation Criteria In Solid Tumours (RECIST version 1.1)|From baseline, i.e. up to 28 days before first study drug dose, and then every 2 cycles (8 weeks) up to objective disease progression by RECIST, assessed up to 35 months|Full analysis set - all treated patients||Percentage of Participants||95% Confidence Interval|Number
794444|NCT00912782|Secondary|25-hydroxyvitamin D and Serum Calcium||10 weeks|||ng/mL||Standard Deviation|Mean
794445|NCT00912782|Primary|Arteriovenous Fistulae Maturation|Maturation of an AVF is the ability to stick the AVF with two large bore needles at ≥ 6 consecutive dialysis sessions, and achievement of an AVF blood flow >300 ml/min, assessed at six months following AVF creation.|6 months|||percentage of group|||Number
794446|NCT00912795|Secondary|Self-reported 30-day Point Prevalence Abstinence at 12 Weeks|self-reported smoking abstinence in the past 30 days at 12 weeks (<=5 cigarettes)|12 weeks|Intention-to-treat (ITT) analysis: All participants randomized at baseline included in analyses regardless of completion of 12-week follow-up data. Missing equals failure (i.e., smoked cigarettes).||participants|||Number
794447|NCT00912795|Secondary|Self-reported 7-day Point Prevalence Abstinence at 12 Weeks|self-reported smoking abstinence in the past 7 days at 12 weeks (<=5 cigarettes)|12 weeks|Intention-to-treat (ITT) analysis: All participants randomized at baseline included in analyses regardless of completion of 12-week follow-up data. Missing equals failure (i.e., smoked cigarettes).||participants|||Number
794448|NCT00912795|Secondary|CO-verified 7-day Point Prevalence Abstinence at 4 Weeks|self-reported continuous abstinence in the past 7 days at 4 weeks (<=5 cigarettes) verified with carbon monoxide reading (<=8ppm)|4 weeks|Intention-to-treat (ITT) analysis: All participants randomized at baseline included in analyses regardless of completion of 12-week follow-up data. Missing equals failure (i.e., smoked cigarettes).||participants|||Number
794449|NCT00912795|Primary|Carbon Monoxide-verified Continuous Abstinence at 12 Weeks|self-reported continuous abstinence since quit day (<=5 cigarettes) verified with carbon monoxide reading (<=8ppm)|12-weeks post-quit day|Intention-to-treat (ITT) analysis: All participants randomized at baseline included in analyses regardless of completion of 12-week follow-up data. Missing equals failure (i.e., smoked cigarettes).||participants|||Number
794450|NCT00912808|Secondary|Frequency of Near Falls Per Day||2 weeks|||Number Near Falls/Day||Standard Error|Mean
794451|NCT00912808|Primary|Fall Frequency Per Day|The primary outcomes were fall and near-fall frequency determined using daily event recording by the subjects onto postcards which accumulated data for one week of monitoring, and collected for six weeks per phase. Postcards were mailed back to the investigator weekly.|2 weeks|||Number Falls/Day||Standard Error|Mean
794452|NCT00912912|Primary|12 Week Progression Free Survival Rate in Refractory Germ Cell Tumors Treated With Sunitinib Malate|Measurable disease or response recorded from start of treatment until disease progression/recurrence. Participants who die during therapy or are lost to follow-up shall be counted as progressive disease. Progressive disease defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Evaluation of measurable disease response follows Response Evaluation Criteria in Solid Tumors (RECIST) guidelines.|12 weeks|||Percentage of Participants|||Number
794453|NCT00912925|Secondary|Overall Percent Change From Baseline to Week 26 in Urinary Glycosaminoglycan (GAG) Levels|Urinary Glycosaminoglycan (GAG) Levels: Concentration of GAG relative to creatinine in urine. A greater decrease in GAG level indicates a greater response.|Baseline to Week 26|||ug/mg||Standard Deviation|Mean
794454|NCT00912925|Secondary|Overall Change From Baseline to Week 26 in Active Joint Range of Motion (ROM)|Active Joint Range of Motion (ROM): Shoulder Flexion Ability to maximally raise one's arm overhead without assistance. Shoulder range of motion (mean of left and right arms) measured in degrees (0-180) by goniometry. Greater degree of flexion indicates greater response.|Baseline to Week 26|||Degrees||Standard Deviation|Mean
794455|NCT00912925|Secondary|Overall Change From Baseline to Week 26 in Child Health Assessment Questionnaire/Health Assessment Questionnaire (CHAQ/HAQ) Disability Index Score|CHAQ/HAQ) = Patient questionnaire that measures the degree of disability on a scale of 0 (no disability) to 3 (maximal disability). A lower score indicates a greater response.|Baseline to week 26|||Units on a scale||Standard Deviation|Mean
794456|NCT00912925|Secondary|Overall Percent Change From Baseline to Week 26 in Liver Volume|Liver Organ Volume: Volume of liver measured by Magnetic Resonance Imaging (MRI). Greater decrease in volume indicates a greater response.|Baseline to Week 26|||Cubic centimeters||Standard Deviation|Mean
794457|NCT00912925|Secondary|Overall Change From Baseline to Week 26 in Apnea/Hypopnea Index (AHI)|Apnea/Hypopnea Index (AHI): Number of absent (apnea) and shallow (hypopnea) breaths per hour of sleep. Overall change from Baseline to Week 26 in AHI. A greater decrease in events indicates a greater response.|Baseline to Week 26|||Events per hour||Standard Deviation|Mean
794458|NCT00912925|Primary|Overall Change From Baseline to Week 26 in Six Minute Walk Test (6MWT)|Six Minute Walk Test (6MWT): Distance walked (measured in meters) in 6 minutes. A longer distance indicates a greater response.|Baseline to Week 26|||meters||Standard Deviation|Mean
794459|NCT00912925|Primary|Overall Change From Baseline to Week 26 in Percent Predicted Forced Vital Capacity (FVC)|Percent Predicted Forced Vital Capacity (FVC): the maximal exhaled breathe volume following a maximal inhaled breath. Overall Change from Baseline to Week 26 in percent predicted FVC = (observed value)/(predicted value) * 100%). A higher value indicates a greater response.|Baseline to Week 26|||Percent predicted FVC||Standard Deviation|Mean
794501|NCT00913003|Secondary|Number of Participants Experiencing Post Operative Nausea|Nausea at any time during the post operative period for 48 hours|Immediate post operative to 48 hours|||Participants|||Number
794502|NCT00915148|Secondary|Percentage of Women With Delivery Within 6 Hours From Defined Prolonged Labor (in Accordance With WHO Recommendations)||6 hours post determination of prolonged labor|||percentage of participants|||Number
794460|NCT00912964|Secondary|Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) at Week 12 and Final Visit|The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Improvement was defined as at least a one point improvement from Baseline to post-baseline and a major improvement was defined as at least a two point improvement from Baseline to post-baseline in PPBC score.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants at each time point (N) only includes those with baseline and post-baseline values. LOCF was used for the Final Visit analysis.||percentage of participants|||Number
794461|NCT00912964|Secondary|Summary of Baseline, Week 12 and Final Visit Change in Overall Condition on the Patient Global Impression Scale|The patient global impression (PGI) scale assessed the change in the patient's overall condition since the start of the study and was completed by the patient at Baseline and at Week 12/end of treatment. The degree of change was categorized as one of the following: 'Very much improved', 'Much improved', 'Minimally improved', 'No change', 'Minimally worse', 'Much worse', or 'Very much worse'.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. This assessment was completed by English speaking patients in the United States only. LOCF was used for the Final visit analysis.||participants|||Number
794462|NCT00912964|Secondary|Summary of Baseline, Week 12 and Final Visit Change in Bladder Symptoms on the Patient Global Impression Scale|The patient global impression (PGI) scale assessed the change in bladder symptoms since the start of the study and was completed by the patient at Baseline and at Week 12/end of treatment. The degree of change was categorized as one of the following: 'Very much improved', 'Much improved', 'Minimally improved', 'No change', 'Minimally worse', 'Much worse', or 'Very much worse'.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. This assessment was completed by English speaking patients in the United States only. LOCF was used for the Final visit analysis.||participants|||Number
794463|NCT00912964|Secondary|Summary of Baseline, Week 12 and Final Visit Change in Bladder Symptoms on the Clinician Global Impression Scale|The Clinician Global Impression Scale (CGI) assessed the change in the patient's bladder symptoms since the start of the study and was completed by the physician at Baseline and at Week 12/end of treatment. The degree of change was categorized as one of the following: 'Very much improved', 'Much improved', 'Minimally improved', 'No change', 'Minimally worse', 'Much worse', or 'Very much worse'.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. This assessment was completed by English speaking patients in the United States only. LOCF was used for the Final visit analysis.||participants|||Number
794464|NCT00912964|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Number of Non-study Related Visits to Physician|The number of times the patient visited a physician’s office during the 4 weeks prior to each study visit (excluding study visits) because of the patient’s bladder condition.|Baseline and Weeks 4, 8 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants at each time point (N) includes only patients with both baseline and post-baseline values. LOCF was used for the Final Visit analysis.||Physician visits||Standard Deviation|Mean
794465|NCT00912964|Secondary|Change From Baseline to Week 12 and Final Visit in Treatment Satisfaction on Visual Analog Scale (TS-VAS)|The TS-VAS is a visual analog scale (VAS) that asks patients to rate their satisfaction with treatment by placing a vertical mark on a 10 cm line where the endpoints are labeled 'No, not at all' on the left (=0) to 'Yes, completely satisfied' on the right (=10). LS means are from an ANCOVA model with treatment group, gender, and geographical regions as fixed factors and baseline as a covariate. A positive change from baseline indicates improvement.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants included at each time point (N) only includes those with baseline and post-baseline values. LOCF was used for the Final Visit analysis.||scores on a scale||Standard Error|Least Squares Mean
794466|NCT00912964|Secondary|Change From Baseline to Week 12 and Final Visit in Patient Perception of Bladder Condition (PPBC)|The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems’; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. LS means are from an ANCOVA model with treatment group, gender, and geographical regions as fixed factors and baseline as a covariate. A negative change from Baseline score indicates improvement.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants included at each time point (N) only includes those with baseline and post-baseline values. LOCF was used for the Final Visit analysis.||scores on a scale||Standard Error|Least Squares Mean
794467|NCT00912964|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)|The EQ-5D is an international, standardized, generic instrument for describing and evaluating health status. Health status is assessed by patients evaluating their health on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (=0) and 'Best imaginable health state' (=100). On the EQ-5D VAS, a positive change from baseline indicates improvement.|Baseline and Weeks 4, 8 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of participants at each time point (N) includes only patients with both baseline and post-baseline values. LOCF was used for the Final Visit analysis.||scores on a scale||Standard Deviation|Mean
794468|NCT00912964|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:
I am not anxious or depressed; I am moderately anxious or depressed; I am extremely anxious or depressed. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit."|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.||participants|||Number
794469|NCT00912964|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:
I have no pain or discomfort; I have moderate pain or discomfort; I have extreme pain or discomfort. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit."|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.||participants|||Number
794470|NCT00912964|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score|The EQ-5D is a standardized, nondisease-specific instrument for describing health status. Participants were asked which statement best describes their health state with regard to usual activities (work, study or leisure): I have no problems performing my usual activities; I have some problems performing my usual activities; I am unable to perform my usual activities. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available at that Visit.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.||participants|||Number
794471|NCT00912964|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-Care Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:
I have no problems with self-care; I have some problems washing or dressing myself; I am unable to wash or dress myself. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit."|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.||participants|||Number
794472|NCT00912964|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:
I have no problems in walking about; I have some problems in walking about; I am confined to bed.
In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit."|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.||participants|||Number
794473|NCT00912964|Secondary|Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with daily activities over the last 7 days. Percent activity impairment is derived from the patient’s assessment of the degree to which OAB affected their regular daily activities. A higher percentage indicates greater impairment. A negative change from baseline indicates improvement.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants at each time point (N) included patients with both baseline and post-baseline values. LOCF was used for the Final Visit analysis.||percent activity impairment||Standard Deviation|Mean
794474|NCT00912964|Secondary|Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent overall work impairment takes into account both hours missed due to OAB symptoms and the patient’s assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values who were employed. LOCF was used for the Final Visit analysis.||percent overall work impairment||Standard Deviation|Mean
794584|NCT00915499|Primary|Apnea-hypopnea Index (AHI) Per Polysomnography (PSG) at the End of Treatment Period|AHI refers to the number of apneas and hypopneas that occurred per hour of sleep|3 months|||AHI (events/hour)||Standard Deviation|Mean
794676|NCT00916032|Secondary|Mean Residence Time (MRT)- Chromogenic Assay|Computed as total area under the first moment curve (Total AUMC) divided by the total area under the concentration versus time curve (Total AUC)|Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.|Intent to Treat||hour||Standard Deviation|Mean
794475|NCT00912964|Secondary|Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent impairment while working was derived from the patient’s assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values who were employed. LOCF was used for the Final Visit analysis.||percent impairment while working||Standard Deviation|Mean
794476|NCT00912964|Secondary|Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent of work time missed is derived from the number of hours of work missed due to OAB symptoms as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed. A negative change from baseline indicates improvement.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values who were employed. LOCF was used for the Final Visit analysis.||percent work time missed||Standard Deviation|Mean
794477|NCT00912964|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score|"Health-related quality of life was assessed by the HRQL subscales (coping, concern, sleep and social interaction) of the overactive bladder questionnaire (OABq). The HRQL total score was calculated by adding the 4 HRQL subscale scores, and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from Baseline in HRQL score indicates improvements.
LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate."|Baseline and Weeks 4, 8 and 12|"The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for the Final Visit analysis. The number of participants included in the calculation for each time point is noted as N."||scores on a scale||Standard Error|Least Squares Mean
794478|NCT00912964|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Symptom Bother Score|"Overactive bladder symptoms were assessed using the symptom bother scale of the overactive bladder questionnaire. The symptom bother scale consists of 8 questions answered by the participant on a scale from 1-6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from Baseline in symptom bother score indicates improvements.
LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate."|Baseline and Weeks 4, 8 and 12|"The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for the Final Visit analysis. The number of participants included in the calculation for each time point is noted as N."||scores on a scale||Standard Error|Least Squares Mean
794479|NCT00912964|Secondary|Percentage of Responders for Number of Grade 3 or 4 Urgency Episodes|Percentage of participants with a decrease from baseline to final visit in mean number of urgency episodes (grade 3 or 4) at least as large as the pre-specified minimally important difference (MID). The MID was determined to be 1.54 for mean number of urgency episodes (grade 3 or 4). The mean number of urgency episodes was derived from urgency episodes classified by the patient in a 3-day micturition diary as grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale where a score 3=severe urgency and 4=urge incontinence.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.||percentage of participants|||Number
794480|NCT00912964|Secondary|Percentage of Responders for Mean Level of Urgency|Percentage of participants with a decrease from Baseline to Final Visit in mean level of urgency at least as large as the pre-specified minimally important difference (MID). The MID was determined to be 0.24 for mean level of urgency. Mean level of urgency was derived from the average of patients’ ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in a 3-day micturition diary according to the Patient Perception of Intensity of Urgency Scale which ranged from 0 (No urgency) to 4 (Urge incontinence).|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.||percentage of participants|||Number
794481|NCT00912964|Secondary|Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit|The percentage of participants with at least a 50% decrease from baseline in mean number of incontinence episodes per 24 hours during the 3 days prior to each clinic visit derived from the patient micturition diary.|Baseline and Weeks 4, 8 and 12|The full analysis set-incontinence included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary & who had at least 1 incontinence episode at baseline. LOCF was used for the Final Visit analysis. N is the number of patients included at each time point.||percentage of participants|||Number
794482|NCT00912964|Secondary|Percentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit|The percentage of participants with no incontinence episodes for the 3 days prior to each clinic visit derived from the micturition diary recorded by the patient.|Weeks 4, 8 and 12|The full analysis set-incontinence included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary & who had at least 1 incontinence episode at baseline. LOCF was used for the Final Visit analysis. N is the number of patients included at each time point.||percentage of participants|||Number
794483|NCT00912964|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Pads Used Per 24 Hours|"The average number of times a patient records a new pad used per day during the 3-day micturition diary period.
LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate."|Baseline and Weeks 4, 8 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary and who had at least one use of a pad at baseline. LOCF was used for the Final Visit analysis. N is the number of participants included at each time point.||pads||Standard Error|Least Squares Mean
794484|NCT00912964|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours|"Nocturia is defined as waking at night one or more times to void. The average number of times a patient urinated (excluding incontinence only episodes) during sleeping time per day was derived from the 3-day patient micturition diary.
LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate."|Baseline and Weeks 4, 8 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 post baseline micturition measurement in the visit diary and who had at least one nocturia episode at baseline. LOCF was used for the Final Visit analysis. N is the number of participants included at each time point.||nocturia episodes||Standard Error|Least Squares Mean
794485|NCT00912964|Secondary|Change From Baseline to Week 4, Week 8 and Week 12 in Mean Level of Urgency|Average of patients’ ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in a 3-day micturition diary according to the following 5-point categorical scale (Patient Perception of Intensity of Urgency Scale): 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 4, 8 and 12|"The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. LOCF was not utilized for this analysis. The number of participants included in the calculation for each time point is noted as N."||scores on a scale||Standard Error|Least Squares Mean
794486|NCT00912964|Secondary|Change From Baseline to Week 4, Week 8 and Week 12 in Mean Number of Urgency Episodes (Grades 3 or 4) Per 24 Hours|The average number of urgency episodes (the sudden, compelling desire to pass urine, which is difficult to defer), derived from urgency episodes classified by the patient in a 3-day micturition diary as grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 4, 8 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 post baseline micturition measurement in the visit diary and at least 1 episode of urgency grade 3 or 4 at baseline. LOCF was not utilized for this analysis. N is the number of patients included at each time point.||Urgency episodes||Standard Error|Least Squares Mean
794487|NCT00912964|Secondary|Change From Baseline to Week 4, Week 8 and Week 12 in Mean Number of Urgency Incontinence Episodes Per 24 Hours|The involuntary leakage of urine accompanied by or immediately proceeded by urgency, derived from the number of incontinence episodes classified by the patient in a 3-day micturition diary as 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 4, 8 and 12|The full analysis set-Incontinence included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary and who had at least 1 urgency incontinence episode (grade 3 or 4) at baseline. LOCF was not utilized.||Urgency incontinence episodes||Standard Error|Least Squares Mean
794488|NCT00912964|Secondary|Change From Baseline to Week 4, Week 8 and Week 12 in Mean Volume Voided Per Micturition|The average volume voided per micturition was calculated from the volume of each micturition measured by the patient and recorded in a micturition diary for 3 days before the Baseline and Week 4, 8 and 12 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 4, 8 and 12|"The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. LOCF was not utilized in this analysis. The number of participants included in the calculation for each time point is noted as N."||mL||Standard Error|Least Squares Mean
794489|NCT00912964|Secondary|Change From Baseline to Week 8 and Week 12 in Mean Number of Incontinence Episodes Per 24 Hours|The average number of incontinence episodes (any involuntary leakage of urine) per 24 hours was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline, Week 8 and Week 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 8 and 12|The full analysis set-incontinence included all randomized patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 post baseline micturition measurement in the visit diary and at least 1 incontinence episode at baseline. The number of patients included at each time point is noted as “N”. LOCF was not utilized.||Incontinence episodes||Standard Error|Least Squares Mean
794490|NCT00912964|Secondary|Change From Baseline to Week 8 and Week 12 in Mean Number of Micturitions Per 24 Hours|The average number of micturitions (urinations) per 24 hours was calculated from the number of micturitions recorded by the patient in a micturition diary for 3-days before the Baseline, Week 8 and 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 8 and 12|The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. The number of patients included in the calculation for each time point is noted as “N”. LOCF was not used in this analysis.||micturitions||Standard Error|Least Squares Mean
794491|NCT00912964|Secondary|Change From Baseline to End of Treatment (Final Visit) in Mean Number of Urgency Episodes (Grades 3 or 4) Per 24 Hours|The average number of urgency episodes (the sudden, compelling desire to pass urine, which is difficult to defer), derived from urgency episodes classified by the patient in a 3-day micturition diary as grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 post baseline micturition measurement in the visit diary and at least 1 episode of urgency grade 3 or 4 at baseline. Last observation carried forward was utilized.||urgency episodes||Standard Error|Least Squares Mean
794492|NCT00912964|Secondary|Change From Baseline to End of Treatment (Final Visit) in Mean Number of Urgency Incontinence Episodes Per 24 Hours|The involuntary leakage of urine accompanied by or immediately proceeded by urgency, derived from the number of incontinence episodes classified by the patient in a 3-day micturition diary as 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 12|The full analysis set-Incontinence included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary and who had at least 1 urgency incontinence episode at baseline. Last observation carried forward (LOCF) was utilized.||urgency incontinence episodes||Standard Error|Least Squares Mean
794493|NCT00912964|Secondary|Change From Baseline to End of Treatment (Final Visit) in Mean Level of Urgency|Average of patients’ ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in a 3-day micturition diary according to the following 5-point categorical scale (Patient Perception of Intensity of Urgency Scale): 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 12|The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. Last observation carried forward was utilized.||scores on a scale||Standard Error|Least Squares Mean
794494|NCT00912964|Secondary|Change From Baseline to Week 4 in Mean Number of Micturitions Per 24 Hours|The average number of micturitions (urinations) per 24 hours was calculated from the number of micturitions recorded by the patient in a micturition diary for 3-days before the Baseline and Week 4 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 4|The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. Last observation carried forward was not utilized in this analysis.||micturitions||Standard Error|Least Squares Mean
794495|NCT00912964|Secondary|Change From Baseline to Week 4 in Mean Number of Incontinence Episodes Per 24 Hours|The average number of incontinence episodes (any involuntary leakage of urine) per 24 hours was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline and Week 4 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 4|The full analysis set-Incontinence included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary and who had at least 1 incontinence episode at baseline. Last observation carried forward (LOCF) was not utilized in this analysis.||Incontinence episodes||Standard Error|Least Squares Mean
794496|NCT00912964|Primary|Change From Baseline to End of Treatment (Final Visit) in Mean Number of Micturitions Per 24 Hours|The average number of micturitions (urinations) per 24 hours was derived from the number of times a patient urinates (excluding incontinence only episodes) per day recorded by the patient in a micturition diary for 3-days before the Baseline and Week 12 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 12|The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. Last observation carried forward was utilized.||micturitions||Standard Error|Least Squares Mean
794497|NCT00912964|Secondary|Change From Baseline to End of Treatment (Final Visit) in Mean Volume Voided Per Micturition|The average volume voided per micturition was calculated from the volume of each micturition measured by the patient and recorded in a micturition diary for 3 days before the Baseline and Week 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 12|The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. Last observation carried forward was utilized.||mL||Standard Error|Least Squares Mean
794498|NCT00912964|Primary|Change From Baseline to End of Treatment (Final Visit) in Mean Number of Incontinence Episodes Per 24 Hours|The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline and Week 12 clinic visits. Least Squares (LS) Means were generated from an analysis of covariance (ANCOVA) model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 12|The full analysis set-Incontinence included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary and who had at least 1 incontinence episode at baseline. Last observation carried forward (LOCF) was utilized.||Incontinence episodes||Standard Error|Least Squares Mean
794499|NCT00913003|Primary|24 Hour Hydromorphone|Total IV hydromorphone administered during surgery to 24 hours post surgery|24 hour|||miligrams||Standard Deviation|Mean
794503|NCT00915148|Primary|Area Under the Receiver Operating Curve (ROC AUC) Values for Prediction of Vaginal Delivery Using 2D or 3D Ulrasound|Fetal Head descent was first measured as the shortest distance between the outer bony limit of the fetal skull and the Perineum. Fetal head descent was re-assessed by measuring the angle of progression in a mid-sagittal plane. Fetal head-perineum distance was evaluated with using a cut-off of ≤40 mm, while the angle of progression was evaluated using a cut off of ≥ 110 degrees. The ROC curves plotted the percentage sensitivity against the percentage false positive rate for head-perineum distance and angle of progression as measured by ultrasound.|during labor|||percentage probability||95% Confidence Interval|Number
794504|NCT00915278|Secondary|Number of Participants With Perforin Expression|Immunohistochemical staining of tissue biopsies was performed with monoclonal antibodies directed against Perforin.|Predose and postdose|The data was not statistically analyzed as planned due to early study termination.|||||
794505|NCT00915278|Secondary|Number of Participants With Ki67 Expression|Immunohistochemical staining of tissue biopsies was performed with monoclonal antibodies directed against Ki67.|Predose and postdose|The data was not statistically analyzed as planned due to early study termination.|||||
794506|NCT00915278|Secondary|Number of Participants With Caspase 3 Expression|Immunohistochemical staining of tissue biopsies was performed with monoclonal antibodies directed against Caspase 3.|Predose and postdose|The data was not statistically analyzed as planned due to early study termination.|||||
794507|NCT00915278|Secondary|Number of Participants With CD31 Expression|Immunohistochemical staining of tissue biopsies was performed with monoclonal antibodies directed against CD31.|Predose and postdose|The data was not statistically analyzed as planned due to early study termination.|||||
794508|NCT00915278|Secondary|Number of Participants With pFAK Expression|Immunohistochemical staining of tissue biopsies was performed with monoclonal antibodies directed against pFAK.|Predose and postdose|The data was not statistically analyzed as planned due to early study termination.|||||
794509|NCT00915278|Secondary|Number of Participants With CD16 Expression|Immunohistochemical staining of tissue biopsies was performed with monoclonal antibodies directed against CD16.|Predose and postdose|The analyzed population is all enrolled subjects treated who had received at least 1 dose of PF-04605412 and completed sampling for PK profiles for PF‑04605412; N = number of subjects who had reportable CD16 expression.||Participants|||Number
794510|NCT00915278|Secondary|Number of Participants With CD56 Expression|Immunohistochemical staining of tissue biopsies was performed with monoclonal antibodies directed against CD56.|Predose and postdose|The analyzed population is all enrolled subjects treated who had received at least 1 dose of PF-04605412 and completed sampling for PK profiles for PF‑04605412; N = number of subjects who had reportable CD56 expression.||Participants|||Number
794511|NCT00915278|Secondary|Number of Participants With Granzyme B Expression|Immunohistochemical staining of tissue biopsies was performed with monoclonal antibodies directed against Granzyme B.|Predose and postdose|The data was not statistically analyzed as planned due to early study termination.|||||
794512|NCT00915278|Secondary|Number of Participants With CD68 Expression|Immunohistochemical staining of tissue biopsies was performed with monoclonal antibodies CD68.|Predose and postdose|The data was not statistically analyzed as planned due to early study termination.|||||
794513|NCT00915278|Secondary|Number of Participants With Integrin Alpha 5 Beta 1 Expression|Immunohistochemical staining of tissue biopsies was performed with monoclonal antibodies directed against integrin alpha 5 beta 1.|Predose and postdose|The data was not statistically analyzed as planned due to early study termination.|||||
794514|NCT00915278|Secondary|Number of Participants With Tissue Macrophage Infiltration|Immunohistochemical staining of tissue biopsies was performed with monoclonal antibodies directed against tissue macrophages.|Predose and postdose|The data was not statistically analyzed as planned due to early study termination.|||||
794515|NCT00915278|Secondary|Percent Change in Initial Area Under the Curve (IAUC)|Percent change in the IAUC for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) from baseline to Cycle 1 Day 15. IAUC reflects the contrast distribution volume (extravascular extracellular space) in addition to contrast delivery and transport across the vascular endothelium. An IAUC value of zero indicates the absence of disease (ie, no leakage of the contrast agent into the synovial volume); therefore, an increase in this parameter indicates worsening disease (ie, greater permeability of the synovial membrane).|Screening, and Cycle 1 Day 15|The data was not statistically analyzed as planned due to early study termination.|||||
794516|NCT00915278|Secondary|Percent Change in Transfer Constant (Ktrans) From Baseline to Cycle 1 Day 15|Percent change in Ktrans for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) from baseline to Cycle 1 day 15 aimed at defining the effect of PF-04605412 on tumor vasculature.|Screening, and Cycle 1 Day 15|The data was not statistically analyzed as planned due to early study termination.|||||
794517|NCT00915278|Secondary|Objective Response - Number of Participants With Objective Response|"Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.
Per RECIST v1.0: CR defined as disappearance of all target lesions and non-target lesions. PR defined as ≥30% decrease in sum of the longest diameters dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non target lesions."|Baseline up to 6 weeks after the first infusion of PF-04605412 (end of Cycle 2) and approximately every 6 weeks thereafter only in the absence of progressive disease|All subjects enrolled in this study who were treated with at least one dose of PF-04605412.||participants|||Number
794518|NCT00915278|Secondary|Number of Participants Positive for Anti-PF04605412 Antibodies|Serum samples were analyzed for anti-drug antibodies (ADA) or human anti-human antibodies (HAHA). This was used to evaluate immunogenicity.|Baseline up to end of treatment|All subjects enrolled in this study who were treated with at least one dose of PF-04605412.||participants|||Number
794629|NCT00915590|Secondary|Central Corneal Thickness|The Principal Investigator decided to terminate the study and stop enrollment because of difficulty recruiting subjects. Although data were collected for this Outcome Measure, no analysis was performed. All records were destroyed following the required retention period. Data are no longer available for analysis.|64 Weeks|The Principal Investigator decided to terminate the study and stop enrollment because of difficulty recruiting subjects. Although data were collected for this Outcome Measure, no analysis was performed. All records were destroyed following the required retention period. Data are no longer available for analysis.|||||
794519|NCT00915278|Secondary|Volume of Distribution at Steady State (Vss)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.|Predose, 1, 2, 2.5, 3, 6, 10, 24 hours after the start of infusion on Day 1; Days 3, 5, 8, 11, 15, 22 of Cycle 1|The analyzed population is all enrolled subjects treated who had received at least 1 dose of PF-04605412 and completed sampling for PK profiles for PF‑04605412; N = number of subjects who had reportable Vss.||Liter||Geometric Coefficient of Variation|Geometric Mean
794520|NCT00915278|Secondary|Systemic Clearance (CL)|CL is a quantitative measure of the rate at which a drug substance is removed from the body.|Predose, 1, 2, 2.5, 3, 6, 10, 24 hours after the start of infusion on Day 1; Days 3, 5, 8, 11, 15, 22 of Cycle 1|The analyzed population is all enrolled subjects treated who had received at least 1 dose of PF-04605412 and completed sampling for PK profiles for PF‑04605412; N = number of subjects who had reportable CL.||Liter/hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
794521|NCT00915278|Secondary|Time to Reach Maximum Observed Serum Concentration (Tmax)||Predose, 1, 2, 2.5, 3, 6, 10, 24 hours after the start of infusion on Day 1; Days 3, 5, 8, 11, 15, 22 of Cycle 1|The analyzed population is all enrolled subjects treated who had received at least 1 dose of PF-04605412 and completed sampling for PK profiles for PF‑04605412; N = number of subjects who had reportable Tmax.||hours||Full Range|Median
794522|NCT00915278|Secondary|Serum Decay Half-Life (t1/2)|Serum decay half-life is the time measured for the plasma concentration to decrease by one half.|Predose, 1, 2, 2.5, 3, 6, 10, 24 hours after the start of infusion on Day 1; Days 3, 5, 8, 11, 15, 22 of Cycle 1|The analyzed population is all enrolled subjects treated who had received at least 1 dose of PF-04605412 and completed sampling for PK profiles for PF‑04605412; N = number of subjects who had reportable t1/2.||hours||Standard Deviation|Mean
794523|NCT00915278|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - Inf)]|AUC (0 - inf)= Area under the serum concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf).|Predose, 1, 2, 2.5, 3, 6, 10, 24 hours after the start of infusion on Day 1; Days 3, 5, 8, 11, 15, 22 of Cycle 1|The analyzed population is all enrolled subjects treated who had received at least 1 dose of PF-04605412 and completed sampling for PK profiles for PF‑04605412; N = number of subjects who had reportable AUC (0 - inf).||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
794524|NCT00915278|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the serum concentration time-curve from zero to the last measured concentration (AUClast).|Predose, 1, 2, 2.5, 3, 6, 10, 24 hours after the start of infusion on Day 1; Days 3, 5, 8, 11, 15, 22 of Cycle 1|The analyzed population is all enrolled subjects treated who had received at least 1 dose of PF-04605412 and completed sampling for PK profiles for PF‑04605412; N = number of subjects who had reportable AUClast.||nanogram*hour/milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
794525|NCT00915278|Secondary|Maximum Observed Serum Concentration (Cmax)||Predose, 1, 2, 2.5, 3, 6, 10, 24 hours after the start of infusion on Day 1; Days 3, 5, 8, 11, 15, 22 of Cycle 1|The analyzed population is all enrolled subjects treated who had received at least 1 dose of PF-04605412 and completed sampling for PK profiles for PF‑04605412; N = number of subjects who had reportable Cmax.||nanogram/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
794526|NCT00915278|Primary|Number of Participants With Dose-limiting Toxicities (DLT)|DLT was defined as any of the following events occurring during the first 28 days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 clinically-relevant non-hematologic toxicity,any >= Grade 3 adverse event (AE) graded by National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], version 3.0 without a clear alternative explanation to study treatment relationship occurring during the first 6 weeks of treatment with PF‑04605412. DLT was used to determine maximum tolerated dose (MTD) in this study.|Baseline up to 6 weeks PF-04605412|All subjects enrolled in the dose escalation part of the study who received at least one dose of study medication that remained on study and/or provided safety follow-up for at least 6 weeks, unless discontinuing due to a DLT. Subjects discontinuing the study due to DLT are included||participants|||Number
794527|NCT00915343|Secondary|Comparison on 24-hour Urinary Free Cortisol Between Once Daily and Thrice Daily Therapy-Part A||12 weeks|Part A Safety population consisted of all randomised patients who took at least one dose of study medication. Safety population with participants evaluable for this outcome.||nanomoles per 24 hours||Standard Deviation|Mean
794528|NCT00915343|Secondary|Comparison on Participant Preference by Questionnaire Between Once Daily and Thrice Daily Therapy-Part A|"Participant Preference Questionnaire consisted of the following set of questions:
1. How large was the benefit with OD compared to TID and the responses were recorded as considerably poorer, somewhat poorer, comparable, large, very large; 2. How strongly concur with the following statement: I prefer novel OD to conventional TID and the responses were recorded as strongly disagree, disagree, neutral, strongly, very strongly; 3. How strongly concur with the following statement: I prefer conventional TID to novel OD and the responses were recorded as strongly disagree, disagree, neutral, strongly, very strongly."|Weeks 16 up to 28|Part A ITT population||percentage of preference|||Number
794529|NCT00915343|Secondary|Participant Compliance- Part B|Compliance was calculated as actual consumption/expected consumption Compliance = (Number of dispensed tablets – Number of returned tablets)/(Number of days during the study period x daily Number of hydrocortisone tablets when taking the ordinary daily dose).|Up to Month 6 follow-up|Part B ITT population with participants evaluable for this outcome.||percentage use||Standard Deviation|Mean
794530|NCT00915343|Secondary|Comparison on Participant Compliance Between Once Daily and Thrice Daily Therapy - Part A|Compliance was calculated as actual consumption/expected consumption Compliance = (Number of dispensed tablets – Number of returned tablets)/(Number of days during the study period x daily Number of hydrocortisone tablets when taking the ordinary daily dose).|Weeks 4 up to 28|Part A ITT population with participants evaluable for this outcome.||percentage use||Standard Deviation|Mean
794531|NCT00915343|Secondary|Change From Baseline to 6 Months in Diurnal Fatigue Questionnaire for Day Average- Part B|Diurnal fatigue scores (Visual Analog Scale [VAS] scores of energy, relaxed, less alert, moody, mental fatigue, intellectually slow, difficulty focusing, physical activity) were analyzed with score range from 0 to 100. A lower value corresponds to better well-being.|Baseline (week 0), month 6|Part B ITT population with participants evaluable for this outcome.||scores on a scale||Standard Deviation|Mean
794532|NCT00915343|Secondary|Change From Baseline to 12 Weeks in Diurnal Fatigue Questionnaire for Day Average of Once Daily Therapy - Part A|Diurnal fatigue was assessed at 8 ante meridian (AM), at 12 AM and at 4 post meridian (PM) by a visual analogue scale (VAS) based on 8 domains (energy, relaxed, less alert, moody, mental fatigue, intellectually slow, difficulty focusing, physical activity). Mean values were calculated for the morning (8 AM), the day (12 AM), the evening (4 PM) and mean per day (mean of 8 AM, 12 AM and 4 PM) were analyzed with score range from 0 to 100. A lower value corresponds to better well-being.|Baseline (week 0), Week 12|ITT population with participants evaluable for this outcome.||scores on a scale||Standard Deviation|Mean
794533|NCT00915343|Secondary|Change From Baseline to 6 Months in Quality of Life (QoL) Assessed by Psychological General Well Being (PGWB) Total Scores- Part B|The PGWB consists of 22 self-administered items rated on a scale from 1 (worst level of well-being) to 6 (maximum level of well-being) with a total score ranging from 22 to 132. A higher score represents better well-being.|Baseline (week 0), month 6|Part B ITT population with participants evaluable for this outcome.||scores on a scale||Standard Deviation|Mean
794534|NCT00915343|Secondary|Comparison of Quality of Life (QoL) Assessed by Psychological General Well Being (PGWB) Total Scores Between Once Daily and Thrice Daily Therapy- Part A|The PGWB consists of 22 self-administered items rated on a scale from 1 (worst level of well-being) to 6 (maximum level of well-being) with a total score ranging from 22 to 132. A higher score represents better well-being.|12 weeks|Part A ITT population with participants evaluable for this outcome.||scores on a scale||Standard Deviation|Mean
794535|NCT00915343|Secondary|Change From Baseline to 6 Months in Quality of Life (QoL) Assessed by Fatigue Impact Scale (FIS) Total Score - Part B|FIS is a subject-reported scale that qualifies the impact of fatigue on daily life in participants. It consisted of 40 statements that measure fatigue in 3 areas: physical, cognitive, and psychosocial. This 40-item scale evaluates the construct of perceived impact of fatigue on everyday life. Respondents rated each statement using a 5-point Likert-type scale ranging from 0 (no problem) to 4 (extreme problem). A total score ranged from 0 to 160. A lower value corresponds to better well-being.|Baseline (week 0), month 6|Part B ITT population with participants evaluable for this outcome.||scores on a scale||Standard Deviation|Mean
794536|NCT00915343|Secondary|Comparison of Quality of Life (QoL) Assessed by Fatigue Impact Scale (FIS) Total Score Between Once Daily and Thrice Daily Therapy - Part A|FIS is a subject-reported scale that qualifies the impact of fatigue on daily life in participants. It consisted of 40 statements that measure fatigue in 3 areas: physical, cognitive, and psychosocial. This 40-item scale evaluates the construct of perceived impact of fatigue on everyday life. Respondents rated each statement using a 5-point Likert-type scale ranging from 0 (no problem) to 4 (extreme problem). A total score ranged from 0 to 160. A lower value corresponds to better well-being.|12 weeks|Part A ITT population with participants evaluable for this outcome.||scores on a scale||Standard Deviation|Mean
794537|NCT00915343|Secondary|Change From Baseline to 6 Months in Quality of Life (QoL) Assessed by Short Form-36 Survey (SF-36) For Physical and Mental Component Score - Part B|The SF-36 was a questionnaire used to assess physical functioning and is made up of eight domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health. Transforming and standardizing these domains lead to the calculation of the physical and mental component summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A higher value in the SF-36 questionnaire corresponds to better well-being.|Baseline (week 0), month 6|Part B ITT population with participants evaluable for this outcome.||scores on a scale||Standard Deviation|Mean
794538|NCT00915343|Secondary|Comparison of Quality of Life (QoL) Assessed by Short Form-36 Survey (SF-36) For Physical and Mental Component Score Between Once Daily and Thrice Daily Therapy- Part A|The SF-36 was a questionnaire used to assess physical functioning and is made up of eight domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health. Transforming and standardizing these domains lead to the calculation of the physical and mental component summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A higher value corresponds to better well-being.|12 weeks|Part A ITT population with participants evaluable for this outcome.||scores on a scale||Standard Deviation|Mean
794539|NCT00915343|Secondary|Percentage (%) of Participants With Change From Baseline in Patient Tolerability Questionnaire at Month 6, Assessed by Patient and Investigator – Part B|Patient tolerability questionnaire was assessed by both patient and investigator, the responses were as follows: improvement, no change, worsening and were reported.|Baseline (week 0), month 6|Part B ITT population with participants evaluable for this outcome.||percentage of participants|||Number
794540|NCT00915343|Secondary|Comparison of Overall Patient Tolerability Score Between Once Daily and Thrice Daily Therapy, Assessed by Patient and Investigator – Part A|"Overall patient tolerability score assessed by patient and investigator, ranged from 1 (feeling poor on treatment) to 5 (feeling very well on treatment). The average total score ranges from 1 to 5 with a higher score representing better tolerability of the treatment.
Questionnaire assessed by patient were I have been very poorly on the treatment, I haven’t been very well (or less well) on the treatment, I have been acceptably well on the treatment, I have been well on the treatment and I have been very well on the treatment. Questionnaire assessed by investigator were The patient has been feeling very poorly on the treatment, The patient has not tolerated the treatment well, The patient has tolerated the treatment less well, The patient has tolerated the treatment well and The patient has tolerated the treatment very well."|12 weeks|Part A ITT population||scores on a scale||Standard Deviation|Mean
794541|NCT00915343|Secondary|Accumulation Ratio (Rac) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|The Rac was calculated as area under the S-cortisol concentration versus time curve during a dosing interval at steady state (AUCtau) on Day 28 divided by AUC0-24h on Day 1. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.||ratio||Standard Deviation|Mean
794542|NCT00915343|Secondary|Percentage (%) of Fluctuation in Concentrations of S-cortisol at Steady State in Plasma After Single and Multiple Dosing During Part A|Percentage of fluctuation was calculated by using formula 100*(Cmax-minimum plasma concentration [Cmin])/Cavg,ss. It was peak trough fluctuation within one dosing interval at steady state. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.||percentage of fluctuation||Standard Deviation|Mean
794543|NCT00915343|Secondary|Percentage (%) of Area Under the Concentration Time Curve (AUC) Extrapolation of S-cortisol in Plasma After Single and Multiple Dosing During Part A|The percentage of AUC0-inf that is due to extrapolation from Tlast to infinity (AUC%Extrapolation) was calculated by using the formula AUC%extrapolation = 100*(AUC0-inf minus AUC0-t)/AUC0-inf. The function of this parameter was to provide information about what percentage of the theoretical curve (AUC0-inf) was possible to determine experimentally (AUC0-t). Therefore, on average, it is expected that the residual area (AUCextrapolation) is not greater than 20%. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.||percentage of AUC||Standard Deviation|Mean
794544|NCT00915343|Secondary|First Detectable Concentration Adjusted by Dose (Cfirst/Dose) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.||per liter||Standard Deviation|Mean
794545|NCT00915343|Secondary|Time to First Detectable Concentration Adjusted by Dose (Tfirst/Dose) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.||(hour per nanomole)*10^6||Standard Deviation|Mean
794546|NCT00915343|Secondary|Maximal Concentration Adjusted by Dose (Cmax1/Dose) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated. Cmax1 is the Cmax after first dose of study drug. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.||per liter||Standard Deviation|Mean
794547|NCT00915343|Secondary|Average Concentration of S-cortisol During the Dosing Interval at Steady State Adjusted by Dose (Css,av/Dose) in Plasma After Single and Multiple Dosing During Part A|Css,av was calculated as the area under the S-cortisol concentration versus time curve during a dosing interval at steady state (AUCtau) divided by dosing interval (tau). Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.||per liter||Standard Deviation|Mean
794548|NCT00915343|Secondary|Area Under the Concentration Time Curve From Zero to 4 Hours Adjusted by Dose (AUC0-4h/Dose) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.||hour per liter||Standard Deviation|Mean
794549|NCT00915343|Secondary|Area Under the Concentration Time Curve From Zero to 10 Hours Adjusted by Dose (AUC0-10h/Dose) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.||hour per liter||Standard Deviation|Mean
794550|NCT00915343|Secondary|Area Under the Concentration Time Curve From Zero to 24 Hours Adjusted by Dose (AUC0-24h/Dose) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.||hour per liter||Standard Deviation|Mean
794551|NCT00915343|Secondary|Area Under the Concentration Time Curve During a Dosing Interval at Steady State Adjusted by Dose (AUCtau/Dose) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body. Participants in Arm 1 underwent standardised in-house PK sampling during 14 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.||hour per liter||Standard Deviation|Mean
794552|NCT00915343|Secondary|Area Under the Concentration Time Curve During a Dosing Interval at Steady State (AUCtau) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body. AUCtau is defined as AUC during a dosing interval at steady state. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.||hour*nanomole per liter||Standard Deviation|Mean
794553|NCT00915343|Secondary|Area Under the Concentration Time Curve (AUC) Between Specified Timepoints of Total S-cortisol in Plasma After Single and Multiple Dosing During Part A|"AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body. AUC between specified timepoints included AUC0-4h, AUC4-12h, AUC6-12h, AUC12-24h, AUC0-10h, AUC4-10h, AUC6-10h, AUC10-24h, AUC(0-inf), AUC(24h-inf). Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported. Here, Nsignifies the number of participants evaluable for this outcome."|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population.||hour*nanomole per liter||Standard Deviation|Mean
794554|NCT00915343|Secondary|Drug Concentration Half-Life From 5 to 14 Hours (t1/2[5-14h]) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|t1/2[5-14h] is the time taken for the blood plasma concentration of a drug to halve from 5 to 14 hours. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.||hours||Standard Deviation|Mean
794555|NCT00915343|Secondary|Drug Concentration Half-Life From 5 to 24 Hours (t1/2[5-24h]) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|t1/2[5-24h] is the time taken for the blood plasma concentration of a drug to halve from 5 to 24 hours. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.||hours||Standard Deviation|Mean
794556|NCT00915343|Secondary|Time to Reach a Concentration of 200 Nanometers (nM) (T200) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.||hours||Full Range|Median
794557|NCT00915343|Secondary|Time to First Detectable Concentration (Tfirst) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.||hours||Full Range|Median
794677|NCT00916032|Secondary|FVIII Clearance- One-stage aPTT Assay|Computed as the dose divided by total AUC|Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.|Intent to Treat||mL/(kg·h)||Standard Deviation|Mean
794558|NCT00915343|Secondary|Time to Peak Plasma Concentration (Tmax2) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached. Tmax2 is the Tmax after second dose of study drug. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.||hours||Full Range|Median
794559|NCT00915343|Secondary|Time to Peak Plasma Concentration (Tmax1) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached. Tmax1 is the Tmax after first dose of study drug. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.||hours||Full Range|Median
794560|NCT00915343|Secondary|Concentration at 7 Hours (C7h) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.||nanomoles per liter||Standard Deviation|Mean
794561|NCT00915343|Secondary|Concentration at 6 Hours (C6h) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.||nanomoles per liter||Standard Deviation|Mean
794562|NCT00915343|Secondary|First Detectable Concentration (Cfirst) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.||nanomoles per liter||Standard Deviation|Mean
794563|NCT00915343|Secondary|Average Concentration of S-cortisol During the Dosing Interval at Steady State (Css,av) in Plasma After Single and Multiple Dosing During Part A|Css,av was calculated as the area under the S-cortisol concentration versus time curve during a dosing interval at steady state (AUCtau) divided by dosing interval (tau). Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.||nanomoles per liter||Standard Deviation|Mean
794564|NCT00915343|Secondary|Maximal Concentration (Cmax2) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated. Cmax2 is the Cmax after second dose of study drug. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.||nanomoles per liter||Standard Deviation|Mean
794565|NCT00915343|Secondary|Maximal Concentration (Cmax1) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated. Cmax1 is the Cmax after first dose of study drug. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.||nanomoles per liter||Standard Deviation|Mean
794630|NCT00915590|Secondary|Best Spectacle-Corrected Visual Acuity (BSCVA)|The Principal Investigator decided to terminate the study and stop enrollment because of difficulty recruiting subjects. Although data were collected for this Outcome Measure, no analysis was performed. All records were destroyed following the required retention period. Data are no longer available for analysis.|64 weeks|The Principal Investigator decided to terminate the study and stop enrollment because of difficulty recruiting subjects. Although data were collected for this Outcome Measure, no analysis was performed. All records were destroyed following the required retention period. Data are no longer available for analysis.|||||
794566|NCT00915343|Primary|Area Under the Concentration Time Curve From Zero to 24 Hours (AUC0-24h) of Total S-cortisol in Plasma After Multiple Doses During Part A|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The data for combined arm 1+2 after multiple doses were reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A: Intention-To-Treat (ITT) set included all randomised participants who took at least 1 dose of study drug with primary efficacy assessments including all pharmacokinetic (PK) samplings during either treatment period. Here “number of participants analysed” signifies those who were evaluable for the outcome measure.||hour*nanomole per liter||Standard Deviation|Mean
794567|NCT00915356|Secondary|Percentage of Patients, Discharged Within 6 h (QTcF ≤500 ms) After Start of Infusion|Percentage, with 95% confidence interval, of patients with QTcF≤500 ms six hours following start of study drug infusion|Six hours following start of study drug infusion|||Percent of participants||95% Confidence Interval|Number
794568|NCT00915356|Secondary|Conversion From AF to SR Within 90 Minutes From Start of Infusion in the Subgroup of Patients With Duration of Current AF Episode 31 Days - 3 Months|Subgroup analysis for patients with duration of current AF episode 31 days – 3 months. Number of patients converting from AF to SR.|Conversion from AF to SR within 90 minutes from start of infusion|||Participants|||Number
794569|NCT00915356|Secondary|Conversion From AF to SR Within 90 Minutes From Start of Infusion in the Subgroup of Patients With Duration of Current AF Episode 8 Days - 30 Days.|Subgroup analysis for patients with duration of current AF episode 8 days - 30 days. Number of patients converting from AF to SR.|Conversion from AF to SR within 90 minutes from start of infusion|||Participants|||Number
794570|NCT00915356|Secondary|Conversion From AF to SR Within 90 Minutes From Start of Infusion in the Subgroup of Patients With Duration of Current AF Episode 10 Hours to 7 Days||Conversion from AF to SR within 90 minutes from start of infusion|||Participants|||Number
794571|NCT00915356|Secondary|Maximal Observed Plasma Concentration of AZD1305|Plasma concentration of AZD1305|Up to 24 hours following start of study drug infusion|||mol/L||Full Range|Median
794572|NCT00915356|Secondary|Study the Relationship Between Systemic Exposure and Response, With Special Regards to Conversion of AF to SR and the Effect on the QTcF Interval.||Since this study is no longer intended to be part of any marketing authorisation application, the analyses addressing this objective were not conducted.||||||
794573|NCT00915356|Secondary|Heart Rhythm. Number of Patients Remaining in SR up to 13 to 18 Days Following Study Drug Infusion.|Number of patients in SR at day 13-18|During 13 to 18 days following study drug infusion|||Participants|||Number
794574|NCT00915356|Secondary|Heart Rhythm. Number of Patients Remaining in SR up to 24 h Following Start of Study Drug Infusion||During 24 hours following start of study drug infusion|||Participants|||Number
794575|NCT00915356|Secondary|Heart Rhythm. Number of Participants With Early Relapse Into AF.|Early relapse into AF within 5 minutes from obtaining the defined criterion for conversion to SR (i.e.1 minute in SR). Patients never converted are not included in the analysis.|Within 5 minutes following investigational product (IP) induced conversion, or direct current (DC) cardioversion, of AF to SR|||Participants|||Number
794576|NCT00915356|Secondary|Wide QRS Tachycardias|Number of patients with wide QRS tachycardias, determined as significant arrhythmias by an Adjudication Committee (AC). The AC analysed and classified the occurrence of significant arrhythmias (other than AF or AFl) and pauses based on the 12-lead Holter reports. All pauses (≥3 sec) and all wide QRS complex tachycardias (≥3 beats, QRS ≥120 ms, and ≥120 bpm).|From start of study drug infusion until discharge from hospital on study day 2.|||Participants|||Number
794577|NCT00915356|Primary|Conversion of Atrial Fibrillation (AF) and Maintenance of Sinus Rhytm (SR)|Conversion of AF to SR with maintenance of SR maintained for at least 1 minute|Within 90 minutes from start of infusion|||Percentage of patients converted to SR||95% Confidence Interval|Number
794578|NCT00915356|Primary|Dose-response Relationship for QTcF Interval of AZD1305|QTcF-QT interval corrected for the RR interval (the time elapsing between two consecutive R waves in the electrocardiogram (ECG)) using the Fridericia formula.For each of 3 consecutive beats (5 consecutive beats if AF) a manual measurement, preferably in lead V2, of QTend intervals was done.The mean QT values of the 3 consecutive beats (5 consecutive beats if AF) were, together with RR intervals, date & time of the ECG, entered into the eCase Report Form (eCRF).The selected beats had to be marked with calipers and noted together with measured values and calculations on the print-out and signed|At any time post randomisation until end of Holter recording (18-24 hours post start of drug infusion).|||ms||95% Confidence Interval|Mean
794579|NCT00915473|Secondary|Mean Number of Days With Acute Medication Use|"Acute medication use meant the consumption of a drug to abort or terminate a headache."|4 weeks post-injection|Because of missing data, 33 subjects in the active arm and 30 subjects in the placebo arm were analyzed.||days per 4 weeks||Standard Deviation|Mean
794580|NCT00915473|Secondary|Mean Number of Hours With Moderate or Severe Migraine||4 weeks post-injection|Because of missing data, 33 subjects in the active arm and 30 subjects in the placebo arm were analyzed.||hours per 4 weeks||Standard Deviation|Mean
794581|NCT00915473|Secondary|Mean Frequency of Days With a Migraine||4 weeks post-injection|Because of missing data, 33 subjects in the active arm and 30 subjects in the placebo arm were analyzed.||days per 4 weeks||Standard Deviation|Mean
794582|NCT00915473|Primary|Number of Subjects With at Least 50% Reduction in the Frequency of Days With Moderate or Severe Migraine in the 4 Week Post Injection Compared to the 4 Week Pre-injection Baseline Period|The baseline frequency will be the number of calendar days with moderate or severe migraine during the 4 week period prior to injection, and the follow-up frequency will be the number of calendar days with migraine during the 4 week period following injection.|4 weeks pre-injection baseline, 4 weeks post-injection|Because of missing data, 33 subjects in the active arm and 30 subjects in the placebo arm were analyzed.||participants|||Number
794583|NCT00915499|Secondary|Quality of Life Measured by the Sleep Apnea Quality of Life Index (SAQLI)|Likert scale measured from 0-7. The minimum important difference a change of 0.5 when a 7-item Likert scale is used. 0 represents the most negative response, 7 represents the most positive response.|3 months|||units on a scale||Standard Deviation|Mean
794585|NCT00915525|Secondary|Change From Study Baseline in Daily Frequency of Urgency Episodes|The number of urgency episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of urgency episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in urgency episodes (improvement) and a positive number change from baseline indicates an increase in the number of urgency episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 6|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Number of Episodes||Standard Deviation|Mean
794586|NCT00915525|Secondary|Change From Study Baseline in Daily Frequency of Urgency Episodes|The number of urgency episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of urgency episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in urgency episodes (improvement) and a positive number change from baseline indicates an increase in the number of urgency episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 5|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Number of Episodes||Standard Deviation|Mean
794587|NCT00915525|Secondary|Change From Study Baseline in Daily Frequency of Urgency Episodes|The number of urgency episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of urgency episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in urgency episodes (improvement) and a positive number change from baseline indicates an increase in the number of urgency episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 4|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Number of Episodes||Standard Deviation|Mean
794588|NCT00915525|Secondary|Change From Study Baseline in Daily Frequency of Urgency Episodes|The number of urgency episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of urgency episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in urgency episodes (improvement) and a positive number change from baseline indicates an increase in the number of urgency episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 3|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Number of Episodes||Standard Deviation|Mean
794589|NCT00915525|Secondary|Change From Study Baseline in Daily Frequency of Urgency Episodes|The number of urgency episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of urgency episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in urgency episodes (improvement) and a positive number change from baseline indicates an increase in the number of urgency episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 2|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Number of Episodes||Standard Deviation|Mean
794590|NCT00915525|Secondary|Change From Study Baseline in Daily Frequency of Urgency Episodes|The number of urgency episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of urgency episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in urgency episodes (improvement) and a positive number change from baseline indicates an increase in the number of urgency episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 1|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Number of Episodes||Standard Deviation|Mean
794591|NCT00915525|Secondary|Change From Study Baseline in the KHQ Social Limitations Domain|The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The social limitations domain consists of 4 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.|Study Baseline, Week 12 Treatment Cycle 6|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Scores on a Scale||Standard Deviation|Mean
794678|NCT00916032|Secondary|FVIII Clearance- Chromogenic Assay|computed as the dose divided by total AUC|Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.|Intent to Treat||mL/(kg·h)||Standard Deviation|Mean
794592|NCT00915525|Secondary|Change From Study Baseline in the KHQ Social Limitations Domain|The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The social limitations domain consists of 4 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.|Study Baseline, Week 12 Treatment Cycle 5|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Scores on a Scale||Standard Deviation|Mean
794593|NCT00915525|Secondary|Change From Study Baseline in the KHQ Social Limitations Domain|The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The social limitations domain consists of 4 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.|Study Baseline, Week 12 Treatment Cycle 4|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Scores on a Scale||Standard Deviation|Mean
794594|NCT00915525|Secondary|Change From Study Baseline in the KHQ Social Limitations Domain|The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The social limitations domain consists of 4 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.|Study Baseline, Week 12 Treatment Cycle 3|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Scores on a Scale||Standard Deviation|Mean
794595|NCT00915525|Secondary|Change From Study Baseline in the KHQ Social Limitations Domain|The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The social limitations domain consists of 4 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.|Study Baseline, Week 12 Treatment Cycle 2|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Scores on a Scale||Standard Deviation|Mean
794596|NCT00915525|Secondary|Change From Study Baseline in the KHQ Social Limitations Domain|The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The social limitations domain consists of 4 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.|Study Baseline, Week 12 Treatment Cycle 1|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Scores on a Scale||Standard Deviation|Mean
794597|NCT00915525|Secondary|Change From Study Baseline in the KHQ Role Limitations Domain|The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The role limitations domain consists of 2 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.|Study Baseline, Week 12 Treatment Cycle 6|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Scores on a Scale||Standard Deviation|Mean
794598|NCT00915525|Secondary|Change From Study Baseline in the KHQ Role Limitations Domain|The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The role limitations domain consists of 2 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.|Study Baseline, Week 12 Treatment Cycle 5|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Scores on a Scale||Standard Deviation|Mean
794599|NCT00915525|Secondary|Change From Study Baseline in the KHQ Role Limitations Domain|The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The role limitations domain consists of 2 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.|Study Baseline, Week 12 Treatment Cycle 4|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Scores on a Scale||Standard Deviation|Mean
794600|NCT00915525|Secondary|Change From Study Baseline in the KHQ Role Limitations Domain|The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The role limitations domain consists of 2 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.|Study Baseline, Week 12 Treatment Cycle 3|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Scores on a Scale||Standard Deviation|Mean
794601|NCT00915525|Secondary|Change From Study Baseline in the KHQ Role Limitations Domain|The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The role limitations domain consists of 2 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.|Study Baseline, Week 12 Treatment Cycle 2|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Scores on a Scale||Standard Deviation|Mean
794602|NCT00915525|Secondary|Change From Study Baseline in the King’s Health Questionnaire (KHQ) Role Limitations Domain|The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The role limitations domain consists of 2 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.|Study Baseline, Week 12 Treatment Cycle 1|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Scores on a Scale||Standard Deviation|Mean
794603|NCT00915525|Secondary|Change From Study Baseline in the I-QOL Questionnaire Total Summary Score|The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL|Study Baseline, Week 12 Treatment Cycle 6|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Scores on a Scale||Standard Deviation|Mean
794604|NCT00915525|Secondary|Change From Study Baseline in the I-QOL Questionnaire Total Summary Score|The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL|Study Baseline, Week 12 Treatment Cycle 5|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Scores on a Scale||Standard Deviation|Mean
794605|NCT00915525|Secondary|Change From Study Baseline in the I-QOL Questionnaire Total Summary Score|The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL|Study Baseline, Week 12 Treatment Cycle 4|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Scores on a Scale||Standard Deviation|Mean
794606|NCT00915525|Secondary|Change From Study Baseline in the I-QOL Questionnaire Total Summary Score|The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL|Study Baseline, Week 12 Treatment Cycle 3|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Scores on a Scale||Standard Deviation|Mean
794607|NCT00915525|Secondary|Change From Study Baseline in the I-QOL Questionnaire Total Summary Score|The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL|Study Baseline, Week 12 Treatment Cycle 2|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Scores on a Scale||Standard Deviation|Mean
794608|NCT00915525|Secondary|Change From Study Baseline in the Urinary Incontinence-Specific Quality of Life (I-QOL) Questionnaire Total Summary Score|The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL.|Study Baseline, Week 12 Treatment Cycle 1|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Scores on a Scale||Standard Deviation|Mean
794609|NCT00915525|Secondary|Change From Study Baseline in the Daily Average Number of Micturition Episodes|The number of micturition (urination) episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of micturition episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in micturition episodes (improvement) and a positive number change from baseline indicates an increase in the number of micturition episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 6|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Number of Episodes||Standard Deviation|Mean
794610|NCT00915525|Secondary|Change From Study Baseline in the Daily Average Number of Micturition Episodes|The number of micturition (urination) episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of micturition episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in micturition episodes (improvement) and a positive number change from baseline indicates an increase in the number of micturition episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 5|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Number of Episodes||Standard Deviation|Mean
794611|NCT00915525|Secondary|Change From Study Baseline in the Daily Average Number of Micturition Episodes|The number of micturition (urination) episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of micturition episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in micturition episodes (improvement) and a positive number change from baseline indicates an increase in the number of micturition episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 4|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Number of Episodes||Standard Deviation|Mean
794612|NCT00915525|Secondary|Change From Study Baseline in the Daily Average Number of Micturition Episodes|The number of micturition (urination) episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of micturition episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in micturition episodes (improvement) and a positive number change from baseline indicates an increase in the number of micturition episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 3|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Number of Episodes||Standard Deviation|Mean
794631|NCT00915590|Primary|Invasion Area (IA), Measuring the Fraction of the Total Corneal Area Invaded by the Vessels|The Principal Investigator decided to terminate the study and stop enrollment because of difficulty recruiting subjects. Although data were collected for this Outcome Measure, no analysis was performed. All records were destroyed following the required retention period. Data are no longer available for analysis.|64 Weeks|The Principal Investigator decided to terminate the study and stop enrollment because of difficulty recruiting subjects. Although data were collected for this Outcome Measure, no analysis was performed. All records were destroyed following the required retention period. Data are no longer available for analysis.|||||
794613|NCT00915525|Secondary|Change From Study Baseline in the Daily Average Number of Micturition Episodes|The number of micturition (urination) episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of micturition episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in micturition episodes (improvement) and a positive number change from baseline indicates an increase in the number of micturition episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 2|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Number of Episodes||Standard Deviation|Mean
794614|NCT00915525|Secondary|Change From Study Baseline in the Daily Average Number of Micturition Episodes|The number of micturition (urination) episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of micturition episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in micturition episodes (improvement) and a positive number change from baseline indicates an increase in the number of micturition episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 1|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Number of Episodes||Standard Deviation|Mean
794615|NCT00915525|Primary|Percentage of Patients With a Positive Response on the 4-Point TBS|The TBS is a single-item scale in which the patient considers his/her current condition (urinary problems, urinary incontinence) compared with his/her condition before receiving any study treatment in study 191622-095 or 191622-520. Response options are: 1 = greatly improved; 2 = improved; 3 = not changed; and 4 = worsened. Patients scoring either “greatly improved” or “improved” are considered to have a positive response.|Week 12 Treatment Cycle 6|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Percentage of Patients|||Number
794616|NCT00915525|Primary|Percentage of Patients With a Positive Response on the 4-Point TBS|The TBS is a single-item scale in which the patient considers his/her current condition (urinary problems, urinary incontinence) compared with his/her condition before receiving any study treatment in study 191622-095 or 191622-520. Response options are: 1 = greatly improved; 2 = improved; 3 = not changed; and 4 = worsened. Patients scoring either “greatly improved” or “improved” are considered to have a positive response.|Week 12 Treatment Cycle 5|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Percentage of Patients|||Number
794617|NCT00915525|Primary|Percentage of Patients With a Positive Response on the 4-Point TBS|The TBS is a single-item scale in which the patient considers his/her current condition (urinary problems, urinary incontinence) compared with his/her condition before receiving any study treatment in study 191622-095 or 191622-520. Response options are: 1 = greatly improved; 2 = improved; 3 = not changed; and 4 = worsened. Patients scoring either “greatly improved” or “improved” are considered to have a positive response.|Week 12 Treatment Cycle 4|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Percentage of Patients|||Number
794618|NCT00915525|Primary|Percentage of Patients With a Positive Response on the 4-Point TBS|The TBS is a single-item scale in which the patient considers his/her current condition (urinary problems, urinary incontinence) compared with his/her condition before receiving any study treatment in study 191622-095 or 191622-520. Response options are: 1 = greatly improved; 2 = improved; 3 = not changed; and 4 = worsened. Patients scoring either “greatly improved” or “improved” are considered to have a positive response.|Week 12 Treatment Cycle 3|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Percentage of Patients|||Number
794619|NCT00915525|Primary|Percentage of Patients With a Positive Response on the 4-Point TBS|The TBS is a single-item scale in which the patient considers his/her current condition (urinary problems, urinary incontinence) compared with his/her condition before receiving any study treatment in study 191622-095 or 191622-520. Response options are: 1 = greatly improved; 2 = improved; 3 = not changed; and 4 = worsened. Patients scoring either “greatly improved” or “improved” are considered to have a positive response.|Week 12 Treatment Cycle 2|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Percentage of Patients|||Number
794620|NCT00915525|Primary|Percentage of Patients With a Positive Response on the 4-Point Treatment Benefit Scale (TBS)|The TBS is a single-item scale in which the patient considers his/her current condition (urinary problems, urinary incontinence) compared with his/her condition before receiving any study treatment in study 191622-095 or 191622-520. Response options are: 1 = greatly improved; 2 = improved; 3 = not changed; and 4 = worsened. Patients scoring either “greatly improved” or “improved” are considered to have a positive response.|Week 12 Treatment Cycle 1|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Percentage of Patients|||Number
794674|NCT00916032|Secondary|Volume of Distribution at Steady State- Chromogenic Assay|computed as Clearance (CL) * Mean residence time (MRT)|Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.|Intent to Treat||dL/kg||Standard Deviation|Mean
794621|NCT00915525|Primary|Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes|Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change from baseline indicates an increase in the number of incontinence episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 6|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Incontinence Episodes||Standard Deviation|Mean
794622|NCT00915525|Primary|Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes|Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change from baseline indicates an increase in the number of incontinence episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 5|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Incontinence Episodes||Standard Deviation|Mean
794623|NCT00915525|Primary|Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes|Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change from baseline indicates an increase in the number of incontinence episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 4|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Incontinence Episodes||Standard Deviation|Mean
794624|NCT00915525|Primary|Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes|Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change from baseline indicates an increase in the number of incontinence episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 3|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Incontinence Episodes||Standard Deviation|Mean
794625|NCT00915525|Primary|Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes|Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change from baseline indicates an increase in the number of incontinence episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 2|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Incontinence Episodes||Standard Deviation|Mean
794626|NCT00915525|Primary|Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes|Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change from baseline indicates an increase in the number of incontinence episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 1|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Incontinence Episodes||Standard Deviation|Mean
794627|NCT00915551|Secondary|Partial Clearance of Actinic Keratoses (AK)|Partial clearance defined as ≥ 75% reduction in the number of AK lesions identified at baseline in the treatment area|baseline and 57 days|Intention to treat population||participants|||Number
794628|NCT00915551|Primary|Complete Clearance of Actinic Keratoses (AK) Lesions|Complete clearance of the treatment field|baseline and 57 days|Intention to treat population||participants|||Number
794675|NCT00916032|Secondary|Mean Residence Time (MRT)- One-stage aPTT Assay|Computed as total area under the first moment curve (Total AUMC) divided by the total area under the concentration versus time curve (Total AUC)|Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.|Intent to Treat||hour||Standard Deviation|Mean
794632|NCT00915590|Primary|Vessel Caliber (VC), Measuring the Mean Diameter of the Corneal Vessels|The Principal Investigator decided to terminate the study and stop enrollment because of difficulty recruiting subjects. Although data were collected for this Outcome Measure, no analysis was performed. All records were destroyed following the required retention period. Data are no longer available for analysis.|64 Weeks|The Principal Investigator decided to terminate the study and stop enrollment because of difficulty recruiting subjects. Although data were collected for this Outcome Measure, no analysis was performed. All records were destroyed following the required retention period. Data are no longer available for analysis.|||||
794633|NCT00915590|Primary|Extent of Neovascular Area (NA)|The Principal Investigator decided to terminate the study and stop enrollment because of difficulty recruiting subjects. Although data were collected for this Outcome Measure, no analysis was performed. All records were destroyed following the required retention period. Data are no longer available for analysis.|64 weeks|The Principal Investigator decided to terminate the study and stop enrollment because of difficulty recruiting subjects. Although data were collected for this Outcome Measure, no analysis was performed. All records were destroyed following the required retention period. Data are no longer available for analysis.|||||
794634|NCT00915590|Primary|Incidence and Severity of Ocular Adverse Event|Incidence and severity of ocular adverse events, as identified by eye examination and visual acuity testing.|64 Weeks|||participants|||Number
794635|NCT00915603|Secondary|Overall Survival (OS)|Assessed from Day 1 of study drug administration to date of death due to any cause.|every 8 weeks until treatment discontinuation, expected average 6 months|||months||95% Confidence Interval|Median
794636|NCT00915603|Secondary|Duration of Response (DOR)|Defined as time between date of objective response and date of response to disease progression or death, as defined by RECIST v1.1 criteria. Objective response is defined as either complete response [CR] or partial response [PR]. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|every 8 weeks until treatment discontinuation, expected average 6 months|||months||95% Confidence Interval|Median
794637|NCT00915603|Secondary|Overall Response Rate (ORR)|The number of patients with observed complete response [CR] or partial response [PR]. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|every 8 weeks until treatment discontinuation, expected average of 18 months|Includes patients who were enrolled and randomized||participants|||Number
794638|NCT00915603|Secondary|Number of Patients With Treatment-related Adverse Events (AEs) as a Measure of Safety and Tolerability|Assessments will be made based on the analysis of reported incidence of treatment-emergent AEs|every 4 weeks until intolerable toxicity occurs|Includes patients who were enrolled, randomized and treated||participants|||Number
794639|NCT00915603|Primary|Progression-Free Survival (PFS)|Progression-free survival will be measured from Day 1 of study drug administration to disease progression defined by Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|every 8 weeks until progressive disease, expected average of 18 months|Includes all enrolled and randomized patients||months||95% Confidence Interval|Median
794640|NCT00915655|Secondary|Virological Response [Viral Load <50 Copies/mL, FDA-SNAPSHOT]|The analysis is based on the last observed viral load (VL) data within the Week 24 window. Virologic response is defined as a VL<50 copies/mL (observed case). Virologic Failure includes a) patients who had >=50 copies/mL in the Week-24 window, b) patients who discontinued prior to Week 24 for lack or loss of efficacy, c) patients who had a switch in their background regimen that was not permitted by the protocol, and d) patients who discontinued for reasons other than adverse events (AEs)/death, and lack or loss of efficacy (provided their last available viral load was detectable).|Week 24|The ITT analysis set was considered the primary efficacy analysis set.||Participants|||Number
794641|NCT00915655|Primary|Virological Response[Viral Load <50 Copies/mL, TLOVR]|The analysis is based on virologic response defined as percentage of patients with confirmed plasma viral load <50 HIV-1 RNA copies/mL at Week 24 calculated according to the Food and Drug Administration (FDA) Time to Loss of Virologic Response (TLOVR) algorithm.|Week 24|The ITT analysis set was considered the primary efficacy analysis set.||Participants|||Number
794642|NCT00915759|Primary|Corneal Re-epithelialization|measured as number of days to complete re-epithelialization, as assessed by daily examination using slit lamp biomicroscopy|participants will be followed daily until complete re-epithelialization, an expected average of 3-5 days post-operatively|Each participant received ProKera on dominant eye and bandage contact lens on fellow non-dominant eye after PRK.For group 3, ProKera and bandage contact lens were left in place until postoperative day 1.||days to complete re-epithelialization|Participants|Standard Deviation|Mean
794643|NCT00915759|Primary|Corneal Re-epithelialization|measured as number of days to complete re-epithelialization, as assessed by daily examination using slit lamp biomicroscopy|participants will be followed daily until complete re-epithelialization, an expected average of 3-5 days post-operatively|Each participant received ProKera on dominant eye and bandage contact lens on fellow non-dominant eye after PRK.For group 2, ProKera and bandage contact lens were left in place until postoperative day 3.||days to complete re-epithelialization|Participants|Standard Deviation|Mean
794644|NCT00915759|Secondary|Tear Protein Analysis||up to 1 month post-operatively||12/2013||||
794645|NCT00915759|Secondary|Corneal Clarity||one year postoperatively||12/2013||||
794646|NCT00915759|Secondary|Long-term Visual Outcomes||one year post-operatively||12/2013||||
794647|NCT00915759|Secondary|Visual Recovery||one year post-operatively||12/2013||||
794648|NCT00915759|Secondary|Complications/Adverse Events||one year post-operatively||12/2013||||
794649|NCT00915759|Secondary|Post-operative Pain|measured subjectively using the Visual Analog Scale (VAS) ranging from 0 (none) to 10 (worst possible pain)|measured daily until complete re-epithelialization, an expected average of 3-5 days post-operatively||12/2013||||
794650|NCT00915759|Primary|Corneal Re-epithelialization|measured as number of days to complete re-epithelialization, as assessed by daily examination using slit lamp biomicroscopy|participants will be followed daily until complete re-epithelialization, an expected average of 3-5 days post-operatively|Each participant received ProKera on dominant eye and bandage contact lens on fellow non-dominant eye after PRK. For group 1, ProKera and bandage contact lens were left in place until complete corneal re-repithelialization (healing).||days to complete re-epithelialization|Participants|Standard Deviation|Mean
794651|NCT00915772|Primary|Clinical Relevant Drug-related Abnormal Findings in Physical Examination and ECG as Reported as AE|Frequency of patients with adverse events by treatment, primary system organ class and preferred term|Baseline and drug stop (up to 54 weeks) + 7 days|Treated Set (TS)||participants|||Number
794652|NCT00915772|Secondary|Change in HbA1c From Baseline Over Time|HbA1c is measured as a percentage. Thus, this change from baseline reflects the visit HbA1c percent minus the baseline HbA1c percent. Baseline is defined as visit 3 from study 1218.46 (NCT00915772).|78 weeks|Non-switcher set (OC) with non-missing data at visit. Only patients who continued on the same treatment in both studies are included||Percentage||Standard Deviation|Mean
794653|NCT00915772|Secondary|Number of Patients With Rescue Therapy||54 weeks|TS||Number of patients|||Number
794654|NCT00915772|Secondary|Change in FPG From Baseline Over Time|Baseline is defined as visit 1 of 1218.52.|54 weeks|TS (OC) with non-missing data at visit||mg/dL||Standard Deviation|Mean
794655|NCT00915772|Secondary|Number of Patients With HbA1c of at Least <0.5% Over Time||54 weeks|Treated Set with non completers considered as failures (NCF)||participant|||Number
794656|NCT00915772|Secondary|Number of Patients With HbA1c <6.5% Over Time||54 weeks|Treated Set with non completers considered as failures (NCF)||participant|||Number
794657|NCT00915772|Secondary|Number of Patients With HbA1c <7.0% After 54 Weeks||54 weeks|Treated Set with non completers considered as failures (NCF)||participant|||Number
794658|NCT00915772|Secondary|Change in HbA1c From Baseline Over Time|HbA1c is measured as a percentage. Thus, this change from baseline reflects the visit HbA1c percent minus the baseline HbA1c percent. Baseline is defined as visit 1 of 1218.52.|54 weeks|TS (OC) with non-missing data at visit||Percentage||Standard Deviation|Mean
794659|NCT00915772|Primary|Possibly Clinically Significant Abnormal Laboratory Parameters: Clinical Chemistry|ULN means upper limit of normal|54 weeks|TS and observed cases (OC). In treatment group L2.5+M500, the number of patients analysed was 224 for lactate dehydrogenase abnormality and total bilirubin abnormality due to anailable data.||participants|||Number
794660|NCT00915772|Primary|Frequency of Patients With Possibly Clinically Significant Abnormal Laboratory Parameters: Haematology||54 weeks|TS and observed cases (OC)||participants|||Number
794661|NCT00915772|Primary|Change From Baseline at Week 54 in Pulse Rate|Baseline is defined as Visit 1 of 1218.52.|54 weeks|TS and observed cases (OC)||beats per minute (bpm)||Standard Deviation|Mean
794662|NCT00915772|Primary|Change From Baseline at Week 54 in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)|Baseline is defined as Visit 1 of 1218.52.|54 weeks|TS and observed cases (OC)||mmHg||Standard Deviation|Mean
794663|NCT00915772|Primary|Frequency of Patients With Adverse Events (AEs)|This includes any AEs detected during routine physical examination and electrocardiogram (ECG) procedures.|54 weeks|Treated Set (TS): all screened patients who were documented to have taken at lease 1 dose of study drug.||participant|||Number
794664|NCT00915798|Secondary|Salivary Cotinine|Average level of salivary cotinine over all time points (microgram/milliliter)|Once per week for 4 weeks|Discrepancies between participants cotinine samples and participant flow are due to the fact that not all participants provided useful saliva samples.||Microgram/milliliter||Standard Deviation|Mean
794665|NCT00915798|Secondary|DRD4 Genotype||one time blood draw|Discrepancies between participant flow and data analyze reflect that not all participants provided blood samples. Dopamine genotypes were only available for participants who were also enrolled in the Multimodal Treatment for ADHD Study (MTA-Study).||Participants|||Count of Participants
794666|NCT00915798|Primary|Brain Activity|BOLD z-score of smokers with ADHD after abstinence/smoking a cigarette, control smokers after abstinence/smoking a cigarette, nonsmokers with ADHD, and control nonsmokers. All participants performed a mathematical task in the MRI scanner. Higher BOLD z-scores indicate greater brain activation.|One MRI session for nonsmokers and two MRI sessions for smokers|Discrepancies between participant flow and number of participants analyzed are due to motion artifacts, which compromised the MRI findings. Thus, a number of participants had to be excluded from the MRI data analysis.||z-score||Standard Deviation|Mean
794667|NCT00915876|Primary|Change in Circulating ICAM-1 Shown by Absolute Values at Baseline, Day 28 and Day 56|Values of ICAM-1 (intracellular adhesion molecule) a measure of vascular reactivity, at three time points: baseline, day 28, and day 56|Day 28 and Day 56|||nanogram/ml||Standard Deviation|Mean
794668|NCT00915902|Primary|Change in Triglyceride Level||after 8 week treatment or placebo period|||mg/dL||Standard Deviation|Mean
794669|NCT00916006|Secondary|Patients With Partial Clearance of Actinic Keratosis (AK)|Patients with partial clearance defined as ≥ 75% reduction in the number of actinic keratosis (AK) lesions identified at baseline in the treatment area|baseline and 57 days|Intention to treat population||participants|||Number
794670|NCT00916006|Primary|Patients With Complete Clearance of Actinic Keratosis (AK) Lesions.|Complete clearance rate of actinic keratosis (AK) lesions, defined as the proportion of patients with no clinically visible AK lesions in the selected treatment area.|57 days|Intention to treat population||participants|||Number
794671|NCT00916032|Secondary|Factor VIII (FVIII) Maximum Plasma Concentration (C-max)- One-stage aPTT Assay|Determined as the highest FVIII activity achieved post-infusion.|Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.|Intent to Treat||IU/dL||Standard Deviation|Mean
794672|NCT00916032|Secondary|Factor VIII (FVIII) Maximum Plasma Concentration (C-max)- Chromogenic Assay|Determined as the highest FVIII activity achieved post-infusion.|Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.|Intent to Treat||IU/dL||Standard Deviation|Mean
794673|NCT00916032|Secondary|Volume of Distribution at Steady State- One-stage aPTT Assay|computed as CL * MRT|Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.|Intent to Treat||dL/kg||Standard Deviation|Mean
794679|NCT00916032|Secondary|Elimination Phase Half-life- One-stage aPTT Assay|calculated as log_e2/λ, where λ is the regression slope in the terminal phase of the least absolute deviations regression model|Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.|||hour||Standard Deviation|Mean
794680|NCT00916032|Secondary|Elimination Phase Half-life- Chromogenic Assay|calculated as log_e2/λ, where λ is the regression slope in the terminal phase of the least absolute deviations regression model|Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.|||hour||Standard Deviation|Mean
794681|NCT00916032|Secondary|Incremental Recovery at 30 Minutes- One-stage aPTT Assay|Change in factor VIII concentration from pre-infusion to 30 minutes post-infusion|30 minutes pre-infusion and 30 minutes post-infusion|Intent to Treat||(IU/dL)/(IU/kg)||Standard Deviation|Mean
794682|NCT00916032|Secondary|Incremental Recovery at 30 Minutes- Chromogenic Assay|Change in factor VIII concentration from pre-infusion to 30 minutes post-infusion|30 minutes pre-infusion and 30 minutes post-infusion|Intent to Treat||(IU/dL)/(IU/kg)||Standard Deviation|Mean
794683|NCT00916032|Secondary|Incremental Recovery at Cmax - One-stage aPTT Assay|Determined as the highest FVIII activity achieved post-infusion|Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3 hours.|Intent to Treat||(IU/dL)/(IU/kg)||Standard Deviation|Mean
794684|NCT00916032|Secondary|Incremental Recovery at Cmax - Chromogenic Assay|Determined as the highest Factor VIII (FVIII) activity achieved post-infusion|Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3 hours.|Intent to Treat||(IU/dL)/(IU/kg)||Standard Deviation|Mean
794685|NCT00916032|Secondary|Area Under the Plasma Concentration Versus Time Curve From 0 to Infinity (AUC 0-infinity). One-stage aPTT Assay|The total area under the plasma concentration versus time curve when the concentration is extrapolated to zero using the slope of the β-phase of the model.|Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.|Intent to Treat||(IU·h)/dL||Standard Deviation|Mean
794686|NCT00916032|Secondary|Area Under the Plasma Concentration Versus Time Curve From 0 to Infinity (AUC 0-infinity). Chromogenic Assay|The total area under the plasma concentration versus time curve when the concentration is extrapolated to zero using the slope of the β-phase of the model.|Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.|Intent to Treat||(IU·h)/dL||Standard Deviation|Mean
794687|NCT00916032|Primary|Area Under the Plasma Concentration Versus Time Curve From 0 to 48 Hours (AUC 0-48h). One-stage Activated Partial Thromboplastin Time (aPTT) Assay|Computed using the linear trapezoidal method.|Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.|Intent to Treat||(IU·h)/dL||Standard Deviation|Mean
794688|NCT00916032|Primary|Area Under the Plasma Concentration Versus Time Curve From 0 to 48 Hours (AUC 0-48h). Chromogenic Assay|Computed using the linear trapezoidal method.|Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.|Intent to Treat||(IU·h)/dL||Standard Deviation|Mean
794689|NCT00916136|Primary|Time to Pass Guidewire After Attaining Starting Point|Time to pass guidewire across reduced fracture once opening reamer is used in OR|while in Emergency Department (ED) up to 24 hours|||minutes||Standard Deviation|Mean
794690|NCT00916136|Primary|Difference in the Two Groups in Regards to Resident Time.|Time from consult entered to time traction apparatus is applied.|while in Emergency Department (ED) up to 24 hours|||minutes||95% Confidence Interval|Mean
794691|NCT00916279|Secondary|Binary Restenosis|Subjects with percent diameter stenosis >50% in the analysis segment.|6 Months|ITT||participants|||Number
794692|NCT00916279|Primary|Change in Diameter Stenosis (%DS) From Post-procedure Through 6 Months|Paired change in percent diameter stenosis (%DS) in the analysis segment from post-procedure through 6 months. I.e., %DS at follow-up less %DS post procedure per patient.|6 Months|ITT||percent diameter stenosis||Standard Deviation|Mean
794693|NCT00916279|Secondary|MACE Rate|Major adverse coronary events (MACE), including the composite of cardiac death, myocardial infarction (MI), and target vessel revascularization (TVR).|30 Days|ITT||Percentage of patients|||Number
794694|NCT00916279|Secondary|Late Lumen Loss|Change in (loss of) lumen diameter from baseline through 6 months in the analysis segment (including the treated segment and 5mm proximal and distal).|6 months|ITT||(mm)||Standard Deviation|Mean
794695|NCT00916279|Primary|Percent Diameter Stenosis (%DS) in the Analysis Segment||6 months|ITT||Percentage stenosis of vessel diameter||Standard Deviation|Mean
794696|NCT00916305|Primary|Reduction in Dangerous Listening Behaviour Defined as Weekly Personal Noise Exposure in dB (LEPD)|Weekly average over the previous month|1 months|||Decibels per week||Standard Deviation|Mean
794697|NCT00916305|Secondary|Reduction in Dangerous Listening Behaviour Defined as Daily Personal Noise Exposure in dB (LEPD) :to be Safe This Should Total Less Than 80dB|Daily average over the previous month|1 months|||Decibels per day||Standard Deviation|Mean
794698|NCT00916344|Secondary|Complication Free Rate|"Complication free rate (in %):
1 minus(the number of possibly pacemaker related complications divided by the number of patients)"|1- and 3- month follow-up completed|||Percentage complication free patients||95% Confidence Interval|Number
794699|NCT00916344|Primary|Efficacy of Atrial Capture Control Feature (Automatic Atrial Threshold Test Minus Manual Atrial Measurement)|"atrial capture control: feature that automatically measures the atrial pacing threshold and subsequently adjusts the atrial pulse amplitude.
atrial threshold test: measurable automatically or manually."|1 month follow-up completed|At 1 month follow-up 93 patients with dual chamber pacemaker had both manual and automatic atrial treshold tests (ITT analysis).||Volt|Participants|95% Confidence Interval|Mean
794721|NCT00916370|Secondary|Stent Thrombosis|Per protocol|Late (31 - 758 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794700|NCT00916357|Secondary|Time to Percentage of Insulin Exposure (as Measured by Area Under the Curve [AUC])|Time to percentage of exposure to insulin, as measured by area under the curve (AUC), following a liquid meal for participants who received Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 is reported. Blood samples were collected at 30, 20, 10, and within 5 minutes before and at 3, 6, 9, 12, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 300, 360, 420, and 480 minutes after injection of each study drug.|Predose up to 480 minutes following after injection of study drug|Participants who received at least 1 dose of Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 with evaluable time to percentage of insulin exposure as measured by area under the curve (AUC) data.||Minutes (min)||Standard Deviation|Mean
794701|NCT00916357|Secondary|Percentage of Participants Without Hypoglycemia|Percentage of participants who received Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 who did not experience hypoglycemia following a liquid meal is reported. Hypoglycemia was defined as any blood glucose values lower than 70 milligrams per deciliter (mg/dL) or symptoms of hypoglycemia responding to treatment with glucose. Blood samples were collected at 30, 20, 10, and within 5 minutes before and at 3, 6, 9, 12, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 300, 360, 420, and 480 minutes after injection of each study drug.|Predose up to 480 minutes after study drug injection|Participants who received at least 1 dose of Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20.||Percentage of participants|||Number
794702|NCT00916357|Secondary|Minimum Postprandial Glucose (PPG)|Minimum postprandial glucose (PPG) in participants who received Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 following a liquid meal is reported. Blood samples were collected at 30, 20, 10, and within 5 minutes before and at 3, 6, 9, 12, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 300, 360, 420, and 480 minutes after injection of each study drug.|Predose up to 480 minutes after study drug injection|Participants who received at least 1 dose of Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 with evaluable minimum postprandial glucose (PPG) data.||Milligrams per deciliter (mg/dL)||Standard Deviation|Mean
794703|NCT00916357|Secondary|Area Under the Time-Concentration Curve for Blood Glucose (AUC[BG])|Area under the time-concentration curve for blood glucose (AUC[BG]) for participants who received Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), and Humulin-R + rHuPH20 following a liquid meal is reported. AUC(BG) values are reported for participants whose blood glucose (BG) was elevated higher than 160 milligrams per deciliter (mg/dL) or 140 mg/dL, or lower than 70 mg/dL within 4 hours of consuming a liquid meal. Blood samples were collected at 30, 20, 10, and within 5 minutes before and at 3, 6, 9, 12, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 300, 360, 420, and 480 minutes after injection of each study drug. Least squares mean difference was calculated and tested using repeated measures analysis of variance with fixed effect for treatment.|Predose up to 480 minutes after study drug injection|Participants who received at least 1 dose of Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 with evaluable area under the time-concentration curve for blood glucose (AUC[BG]) data.||Milligrams per deciliter * minutes||Standard Deviation|Least Squares Mean
794704|NCT00916357|Secondary|Area Under the Concentration Time-Curve for Serum Insulin From Time 0 to the End of Blood Sampling (AUC[Last])|Area under the concentration time-curve for serum insulin from time 0 to the end of blood sampling (AUC[last]) for participants who received Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 during a liquid meal is reported. Blood samples were collected at 30, 20, 10, and within 5 minutes before and at 3, 6, 9, 12, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 300, 360, 420, and 480 minutes after injection of each study drug. Least squares mean difference was calculated and tested using repeated measures analysis of variance with fixed effect for treatment.|Predose up to 480 minutes after study drug injection|Participants who received at least 1 dose of Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 with evaluable area under the concentration time-curve for serum insulin from time 0 to the end of blood sampling (AUC[last]) data.||Minutes * picomoles /1000 (min*pm/1000)||Standard Deviation|Least Squares Mean
794705|NCT00916357|Secondary|Mean Residence Time From Time 0 to the End of Blood Sampling (MRT[Last])|Mean residence time from time 0 to the end of blood sampling (MRT[last]) for participants who received Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 following a liquid meal is reported. Blood samples were collected at 30, 20, 10, and within 5 minutes before and at 3, 6, 9, 12, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 300, 360, 420, and 480 minutes after injection of each study drug.|Predose up to 480 minutes after study drug injection|Participants who received at least 1 dose of Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 with evaluable mean residence time from time 0 to the end of blood sampling (MRT[last]) data.||Minutes (min)||Standard Deviation|Mean
794706|NCT00916357|Secondary|Time to Late 50% Maximum Serum Insulin Concentration (Late[t50%])|Time to late 50% maximum serum insulin concentration (late[t50%]) for participants receiving Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 following a liquid meal is reported. Blood samples were collected at 30, 20, 10, and within 5 minutes before and at 3, 6, 9, 12, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 300, 360, 420, and 480 minutes after injection of each study drug.|Predose up to 480 minutes after study drug injection|Participants who received at least 1 dose of Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 with evaluable time to late 50% maximum serum insulin concentration (late[t50%]) data.||Minutes (min)||Standard Deviation|Mean
794707|NCT00916357|Secondary|Time to Early 50% Maximum Serum Insulin Concentration (Early[t50%])|Time to early 50% maximum serum insulin concentration (early[t50%]) for participants receiving Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 following a liquid meal is reported. Blood samples were collected at 30, 20, 10, and within 5 minutes before and at 3, 6, 9, 12, 15, 20, 25, 30, 45, 60, 75, 90, and 120 minutes after injection of each study drug.|Predose up to 120 minutes after study drug injection|Participants who received at least 1 dose of Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 with evaluable time to early 50% maximum serum insulin concentration (early[t50%]) data.||Minutes (min)||Standard Deviation|Mean
794708|NCT00916357|Secondary|Time To Maximum Serum Insulin Concentration (Tmax)|Time to maximum serum insulin concentration (Tmax) for participants receiving Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 following a liquid meal is reported. Blood samples were collected at 30, 20, 10, and within 5 minutes before and at 3, 6, 9, 12, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 300, 360, 420, and 480 minutes after injection of each study drug.|Predose up to 480 minutes after study drug injection|Participants who received at least 1 dose of Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 with evaluable time to maximum serum insulin concentration (Tmax) data.||Minutes (min)||Standard Deviation|Mean
794709|NCT00916357|Secondary|Maximum Serum Insulin Concentration (Cmax)|Maximum serum insulin concentration (Cmax) for participants receiving Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 is reported. Blood samples were collected at 30, 20, 10, and within 5 minutes before and at 3, 6, 9, 12, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 300, 360, 420, and 480 minutes after injection of each study drug.|Predose up to 480 minutes after study drug injection|Participants who received at least one dose of Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 with evaluable maximum serum insulin concentration (Cmax) data.||Picomoles per liter (pm/L)||Standard Deviation|Mean
794710|NCT00916357|Primary|Postprandial Glucose (PPG) Excursion Following a Liquid Meal|Postprandial glucose (PPG) values in participants receiving Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 following a liquid meal are reported. Blood samples were collected at 30, 20, 10, and within 5 minutes before and at 3, 6, 9, 12, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 300, 360, 420, and 480 minutes after injection of each study drug. Least square mean difference was calculated and tested using repeated measures analysis of variance with fixed effect for treatment.|Predose up to 480 minutes after study drug injection|Participants who received at least 1 dose of Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 with evaluable postprandial glucose (PPG) excursion data.||Milligrams per deciliter (mg/dL)||Standard Deviation|Least Squares Mean
794711|NCT00916370|Secondary|Stent Thrombosis|Per ARC, definite and probable|Overall (0 - 1123 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794712|NCT00916370|Secondary|Stent Thrombosis|Per protocol|Overall (0 - 1123 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794713|NCT00916370|Secondary|Stent Thrombosis|Per ARC, definite and probable|Overall (0-758 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794714|NCT00916370|Secondary|Stent Thrombosis|Per protocol|Overall (0-758 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794715|NCT00916370|Secondary|Stent Thrombosis|Per protocol and per ARC|Overall (0-393 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794716|NCT00916370|Primary|Target Lesion Failure (TLF)|"The composite rate of:
Cardiac Death Target Vessel Myocardial Infarction (TV-MI) and Clinically Indicated Target Lesion Revascularization (CI-TLR) per protocol."|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794717|NCT00916370|Primary|Target Lesion Failure (TLF)|"The composite rate of:
Cardiac Death Target Vessel Myocardial Infarction (TV-MI) and Clinically Indicated Target Lesion Revascularization (CI-TLR) per protocol."|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794718|NCT00916370|Secondary|Stent Thrombosis|Per ARC, definite and probable|Very Late (394 - 1123 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794719|NCT00916370|Secondary|Stent Thrombosis|Per protocol|Late (31 - 1123 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794720|NCT00916370|Secondary|Stent Thrombosis|Per ARC, definite and probable|Very Late (394 - 758 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794722|NCT00916370|Secondary|Stent Thrombosis|Per protocol and per ARC|Late (31 - 393 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794723|NCT00916370|Secondary|Stent Thrombosis|Per protocol and per ARC|Acute/Subacute (0 - 30 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794724|NCT00916370|Secondary|Stent Thrombosis|Per protocol and per ARC|Subacute (>1 - 30 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794725|NCT00916370|Secondary|Stent Thrombosis|Per protocol and per Academic Research Consortium (ARC, definite/probable)|Acute (≤1 day)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794726|NCT00916370|Secondary|All Death/All MI/All Coronary Revascularization|Per Protocol|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794727|NCT00916370|Secondary|All Death/All MI/All Coronary Revascularization|Per Protocol|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794728|NCT00916370|Secondary|All Death/All MI/All Coronary Revascularization|Per Protocol|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794729|NCT00916370|Secondary|All Death/All MI/All Coronary Revascularization|Per Protocol|180 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794730|NCT00916370|Secondary|All Death/All MI/All Coronary Revascularization|Per Protocol|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794731|NCT00916370|Secondary|All Death/All MI/All Coronary Revascularization|Per Protocol|In-hospital is defined as hospitalization less than or equal to 7 days post index procedure|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794732|NCT00916370|Secondary|Cardiac Death/ All MI/CI-TLR|Per Protocol|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794733|NCT00916370|Secondary|Cardiac Death/ All MI/CI-TLR|Per Protocol|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794734|NCT00916370|Secondary|Cardiac Death/ All MI/CI-TLR|Per Protocol|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794735|NCT00916370|Secondary|Cardiac Death/ All MI/CI-TLR|Per Protocol|180 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794736|NCT00916370|Secondary|Cardiac Death/ All MI/CI-TLR|Per Protocol|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794737|NCT00916370|Secondary|Cardiac Death/ All MI/CI-TLR||in-hospital|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794738|NCT00916370|Secondary|Cardiac Death/All MI|Per Protocol|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794739|NCT00916370|Secondary|Cardiac Death/All MI|Per Protocol|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794740|NCT00916370|Secondary|Cardiac Death/All MI|Per Protocol|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794741|NCT00916370|Secondary|Cardiac Death/All MI|Per Protocol|180 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794742|NCT00916370|Secondary|Cardiac Death/ All MI|Per Protocol|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794743|NCT00916370|Secondary|Cardiac Death/All MI||In-hospital is defined as hospitalization less than or equal to 7 days post index procedure|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794744|NCT00916370|Secondary|All Coronary Revascularization (TVR and Non-TVR)||3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794745|NCT00916370|Secondary|All Coronary Revascularization (TVR and Non-TVR)||2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794746|NCT00916370|Secondary|All Coronary Revascularization (TVR and Non-TVR)||1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794747|NCT00916370|Secondary|All Coronary Revascularization (TVR and Non-TVR)||180 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794748|NCT00916370|Secondary|All Coronary Revascularization (TVR and Non-TVR)||30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794749|NCT00916370|Secondary|All Coronary Revascularization (TVR and Non-TVR)||In-hospital is defined as hospitalization less than or equal to 7 days post index procedure|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794750|NCT00916370|Secondary|All TVR (CI and Non-CI)||3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794751|NCT00916370|Secondary|All TVR (CI and Non-CI)||2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794752|NCT00916370|Secondary|All TVR (CI and Non-CI)||1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794753|NCT00916370|Secondary|All TVR (CI and Non-CI)||180 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794816|NCT00916643|Primary|Serious Unexpected Adverse Events||Participants were followed for one (1) year following discontinuation of treatment.|The number of participants for analysis was determined per protocol.||participants|||Number
794754|NCT00916370|Secondary|All TVR (CI and Non-CI)||30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794755|NCT00916370|Secondary|All TVR (CI and Non-CI)||In-hospital is defined as hospitalization less than or equal to 7 days post index procedure|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794756|NCT00916370|Secondary|All TLR (CI and Non-CI)||3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794757|NCT00916370|Secondary|All TLR (CI and Non-CI)||2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794758|NCT00916370|Secondary|All TLR (CI and Non-CI)||1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794759|NCT00916370|Secondary|All TLR (CI and Non-CI)||180 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794760|NCT00916370|Secondary|All TLR (CI and Non-CI)||30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794761|NCT00916370|Secondary|All TLR (CI and Non-CI)||In-hospital is defined as hospitalization less than or equal to 7 days post index procedure|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794762|NCT00916370|Secondary|Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)||3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794763|NCT00916370|Secondary|Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)||2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794764|NCT00916370|Secondary|Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)||1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794765|NCT00916370|Secondary|Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)||180 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794766|NCT00916370|Secondary|Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)||30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794767|NCT00916370|Secondary|Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)||In-hospital is defined as hospitalization less than or equal to 7 days post index procedure|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794768|NCT00916370|Secondary|Clinically Indicated-Target Lesion Revascularization||3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794817|NCT00916643|Primary|Occurrence of Cardiovascular Events and Interventions|Adverse Events reported for Cardiovascular disease not directly related to therapy.|Participants were followed for one (1) year following discontinuation of treatment.|The number of participants for analysis was determined per protocol.||participants|||Number
794769|NCT00916370|Secondary|Clinically Indicated-Target Lesion Revascularization||2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794770|NCT00916370|Secondary|Clinically Indicated-Target Lesion Revascularization||1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794771|NCT00916370|Secondary|Clinically Indicated-Target Lesion Revascularization||180 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794772|NCT00916370|Secondary|Clinically Indicated-Target Lesion Revascularization||30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794773|NCT00916370|Secondary|Clinically Indicated-Target Lesion Revascularization||In-hospital is defined as hospitalization less than or equal to 7 days post index procedure|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794774|NCT00916370|Secondary|Non-target Vessel MI (Q-wave, Non Q-wave)|Per Protocol|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794775|NCT00916370|Secondary|Non-target Vessel MI (Q-wave, Non Q-wave)|Per Protocol|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794776|NCT00916370|Secondary|Non-target Vessel MI (Q-wave, Non Q-wave)|Per Protocol|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794777|NCT00916370|Secondary|Non-target Vessel MI (Q-wave, Non Q-wave)|Per Protocol|180 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794778|NCT00916370|Secondary|Non-target Vessel MI (Q-wave, Non Q-wave)|Per Protocol|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794779|NCT00916370|Secondary|Non-target Vessel MI (Q-wave, Non Q-wave)|Per Protocol|In-hospital is defined as hospitalization less than or equal to 7 days post index procedure|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794780|NCT00916370|Secondary|Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)|Per Protocol|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794781|NCT00916370|Secondary|Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)|Per Protocol|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794782|NCT00916370|Secondary|Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)|Per Protocol|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794783|NCT00916370|Secondary|Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)|Per Protocol|180 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794784|NCT00916370|Secondary|Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)|Per Protocol|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794785|NCT00916370|Secondary|Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)|Per Protocol|In-hospital is defined as hospitalization less than or equal to 7 days post index procedure.|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794786|NCT00916370|Secondary|All Death (Cardiac, Vascular, Non-cardiovascular)||3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794787|NCT00916370|Secondary|All Death (Cardiac, Vascular, Non-cardiovascular)||2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794788|NCT00916370|Secondary|All Death (Cardiac, Vascular, Non-cardiovascular)||1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794789|NCT00916370|Secondary|All Death (Cardiac, Vascular, Non-cardiovascular)||180 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794790|NCT00916370|Secondary|All Death (Cardiac, Vascular, Non-cardiovascular)||30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794791|NCT00916370|Secondary|All Death (Cardiac, Vascular, Non-cardiovascular)||In-hospital is less than or equal to 7 days post index procedure|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794792|NCT00916370|Secondary|Procedural Success (Subject Basis)|Procedure success is defined as achievement of a final in-stent diameter stenosis of < 50% (by QCA). Per Protocol.|From the start of index procedure to end of index procedure|The analysis was done to include only subjects with post index procedure cardiac enzyme data in window (between 8 hours post index procedure and hospital discharge). Out of these subjects, 2 in the CSR and 1 in the LLR did not have QCA data and therefore were excluded. So, the final analysis contained 401 ITT CSR subjects and 105 ITT LLR subjects.||percentage of participants|||Number
794793|NCT00916370|Secondary|Device Success (Lesion Basis)|Device success is defined as achievement of a final in-stent residual diameter stenosis of < 50% (by QCA).|From the start of index procedure to end of index procedure|The analysis was done to include only subjects with post index procedure cardiac enzyme data in window (between 8 hours post index procedure and hospital discharge). Therefore, the final analysis contained 403 ITT CSR subjects and 106 ITT LLR subjects.||percentage of lesions|Participants||Number
794794|NCT00916370|Secondary|Procedure Time|Procedure time is defined as time between insertion and withdrawal of guide catheter.|From insertion to withdrawal of guide catheter|The analysis was done to include only subjects with post index procedure cardiac enzyme data in window (between 8 hours post index procedure and hospital discharge). Therefore, the final analysis contained 403 ITT CSR subjects and 106 ITT LLR subjects.||Minutes||Standard Deviation|Mean
794795|NCT00916370|Primary|Target Lesion Failure (TLF)|"The composite rate of:
Cardiac Death Target Vessel Myocardial Infarction (TV-MI) and Clinically Indicated Target Lesion Revascularization (CI-TLR) per protocol."|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
794796|NCT00916383|Secondary|Safety, Tolerability, and Adhesion|See Adverse Event section for Safety assessment. Adhesion was assessed according to the following scoring criteria: Score 0 = approximately > 90% adhered (essentially no lift off the skin); Score 1 = approximately 75% to < 90% adhered (some edges only lifting off the skin); Score 2 = approximately 50% to < 75% adhered (less than half of the system lifting off the skin); Score of 3 = approximately < 50% adhered but not detached (more than half of the system lifting off the skin without falling off); Score of 4 = Patch-system detached (patch /overlay completely off the skin).|Safety was assessed throughout the study. Adhesion was assessed daily and immediately prior to patch removal on Days 8, 15, and 22.||||||
794797|NCT00916383|Primary|Skin Irritation (Other Skin Effects)|Other skin effects were assessed according to the following scoring criteria: Score 0 = no other effects observed; Score 1 = slight glazed appearance; Score 2 = marked glazing; Score 3 = glazing with peeling and cracking; Score 4 = glazing with fissures; Score 5 = film of dried serous exudate covering all or part of the patch site; Score 6 = small petechial erosions and/or scabs.|1, 24, and 48 hours after patch removal (Days 8-10; Days 15-17; Days 22-24)|All patients who received patches are included in the analysis.||participants|||Number
794798|NCT00916383|Primary|Skin Irritation (Other Skin Effects)|Other skin effects were assessed according to the following scoring criteria: Score 0 = no other effects observed; Score 1 = slight glazed appearance; Score 2 = marked glazing; Score 3 = glazing with peeling and cracking; Score 4 = glazing with fissures; Score 5 = film of dried serous exudate covering all or part of the patch site; Score 6 = small petechial erosions and/or scabs.|Immediately after patch removal|All patients who received patches are included in the analysis. Note: The represented data are based on N = 48 for patients who received the placebo patch and the DTP-system on the Upper Back, N = 46 for patients who received the placebo patch on the side of torso, and N = 47 for patients who received the DTP-system on the side of torso.||participants|||Number
794799|NCT00916383|Primary|Skin Irritation (Papules and Vesicles)|Papules and vesicles were assessed according to the following scoring criteria: Score 0 = no evidence of papules or vesicles; Score 1 = few papules or vesicles (< 10) observed on the skin site; Score 2 = more papules or vesicles (≥ 10) observed on < 50 % of skin site, diffuse or few clusters; Score 3 = many papules or vesicles observed on ≥ 50% of skin site, diffuse or few clusters; Score 4 = many papules or vesicles observed on > 50% of skin site, with multiple (> 3) clusters.|1, 24, and 48 hours after patch removal (Days 8-10; Days 15-17; Days 22-24)|All patients who received patches are included in the analysis.||participants|||Number
794800|NCT00916383|Primary|Skin Irritation (Papules and Vesicles)|Papules and vesicles were assessed according to the following scoring criteria: Score 0 = no evidence of papules or vesicles; Score 1 = few papules or vesicles (< 10) observed on the skin site; Score 2 = more papules or vesicles (≥ 10) observed on < 50 % of skin site, diffuse or few clusters; Score 3 = many papules or vesicles observed on ≥ 50% of skin site, diffuse or few clusters; Score 4 = many papules or vesicles observed on > 50% of skin site, with multiple (> 3) clusters.|Immediately after patch removal|All patients who received patches are included in the analysis. Note: The represented data are based on N = 48 for patients who received the placebo patch and the DTP-system on the Upper Back, N = 46 for patients who received the placebo patch on the side of torso, and N = 47 for patients who received the DTP-system on the side of torso.||participants|||Number
794801|NCT00916383|Primary|Skin Irritation (Edema)|Edema was used to determine skin irritation using a modified Draize scale. Score 0 = no edema; Score 1 = very slight edema; Score 2 = slight edema; Score 3 = moderate to severe edema; Score 4 = severe edema.|1, 24, and 48 hours after patch removal (Days 8-10; Days 15-17; Days 22-24)|All patients who received patches are included in the analysis.||units on a scale||Standard Deviation|Mean
794802|NCT00916383|Primary|Skin Irritation (Erythema)|Erythema was used to determine skin irritation using a modified Draize scale. Score 0 = no erythema; Score 1 = very slight erythema; Score 2 = well-defined erythema; Score 3 = moderate to severe erythema; Score 4 = severe erythema.|1, 24, and 48 hours after patch removal (Days 8-10; Days 15-17; Days 22-24)|All patients who received patches are included in the analysis.||units on a scale||Standard Deviation|Mean
794803|NCT00916383|Primary|Skin Irritation (Erythema and Edema)|Erythema and edema were used to determine skin irritation using a modified Draize scale. Score 0 = no erythema/edema; Score 1 = very slight erythema/edema; Score 2 = well-defined erythema/slight edema; Score 3 = moderate to severe erythema/edema; Score 4 = severe erythema/edema.|Immediately after patch removal|All patients who received patches are included in the analysis. Note: The represented data are based on N = 48 for patients who received the placebo patch and the DTP-system on the Upper Back, N = 46 for patients who received the placebo patch on the side of torso, and N = 47 for patients who received the DTP-system on the side of torso.||units on a scale||Standard Deviation|Mean
794804|NCT00916539|Secondary|Range of Motion: Radial Deviation|Range of motion measures the ability to move the wrist joint after injury.|6 months|||degrees||Standard Deviation|Mean
794805|NCT00916539|Secondary|Range of Motion: Ulnar Deviation|Range of motion measures the ability to move the wrist joint after injury.|6 months|||degrees||Standard Deviation|Mean
794806|NCT00916539|Secondary|Range of Motion: Extension|Range of motion measures the ability to move the wrist joint after injury.|6 months|||degrees||Standard Deviation|Mean
794807|NCT00916539|Secondary|Range of Motion: Flexion|Range of motion measures the ability to move the wrist joint after injury.|6 months|||degrees||Standard Deviation|Mean
794808|NCT00916539|Secondary|Visual Analog Scale for Pain|The pain scale measures the amount of pain on a scale from 0 to 10, where 10 indicates the most pain and 0 is no pain.|6 months|||units on a scale||Standard Deviation|Mean
794809|NCT00916539|Secondary|Grip Strength||6 months|||kilograms||Standard Deviation|Mean
794810|NCT00916539|Secondary|Modified Mayo Wrist Score|The Modified Mayo Wrist Score evaluates wrist function after treatment. The total score ranges from 0 to 100, with higher scores indicating a better result.|6 months|||units on a scale||Standard Deviation|Mean
794811|NCT00916539|Secondary|DASH Questionnaire|This questionnaire measures the disability of the upper extremity. The disability scale is ranked from 0 (least disability) to 100 (most disability).|6 months|||units on a scale||Standard Deviation|Mean
794812|NCT00916539|Primary|Extent of Union|The investigators looked at the extent of fracture union after immobilization.|10 weeks|||percentage of union||Standard Deviation|Mean
794813|NCT00916617|Secondary|Pharmacokinetic Parameters Including Maximal Serum Drug Concentration, Time to Maximal Serum Drug Concentration, and Terminal Half-life of Elimination||36 months|Because this study was terminated early, the planned pharmacokinetic analyses were not performed.|||||
794814|NCT00916617|Primary|Number of Participants Reporting Clinically Significant Magnetic Resonance Imaging (MRI) Findings|A brain Magnetic Resonance Imaging (MRI) was obtained from all participants at Week 13 and quarterly thereafter. Participants were to meet the following criteria: screening brain MRI scan is consistent with the diagnosis of Alzheimer's Disease. Screening diagnosis of probable Alzheimer's disease according to National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria. Clinically significant MRIs were identified by the investigator. The number of participants with clinically significant MRIs are tabulated by visit and treatment group.|Week 13, 26, 39, 52, 65, 78, 91, 104, 117, 130, 143, 156, Any visit|The safety population included all participants who received at least 1 dose of study medication in Study NCT00916617.||Participants|||Number
794815|NCT00916643|Primary|Frequency and Severity of CHD Symptoms (Angina)|This is equatable to the incidence of Cardiovascular AEs.|Participants were followed for one (1) year following discontinuation of treatment.|The number of participants for analysis was determined per protocol.||participants|||Number
794819|NCT00916721|Primary|Change in the Corrugator Muscle (EMG) Level, Caused by Smoking Cues, Measured Using Script Driven Imagery|Corrugator EMG will be obtained through Ag/AgCl electrodes. The amplified EMG signal will be integrated using a 300-msec. time constant. A Coulbourn Modular Instrument System was used to measure corrugator EMG during 4 periods; baseline, reading, imagery and recovery|Corrugator EMG level was measured at visit 3, after presentation of two neutral and two smoking scripts|||µV||Standard Deviation|Mean
794820|NCT00916721|Primary|Change in Heart Rate (Beats Per Minute), Caused by Smoking Cues, Measured Using Script Driven Imagery|Heart rate was measured through 9-mm (sensor diameter) Ag/AgCl electrodes filled with electrolytic paste and placed on the medial surface of each forearm. Amplified electrocardiogram signal will input to a tachometer that will provide a voltage output reflecting interbeat interval, which will be transformed to HR. A Coulbourn Modular Instrument System was used to measure HR during 4 periods; baseline, reading, imagery and recovery|Heart rate was measured at visit 3, after presentation of two neutral and two smoking scripts|||beats per minute||Standard Deviation|Mean
794821|NCT00916721|Primary|Change in the Skin Conductance Level, Caused by Smoking Cues, Measured Using Script Driven Imagery|Skin conductance level was obtained through 9-mm (sensor diameter) Ag/AgCl electrodes filled with isotonic paste placed on the non-dominant hypothenar surface using a constant-voltage technique. A Coulbourn Modular Instrument System was used to measure SC during 4 periods; baseline, reading, imagery and recovery.|skin conductance was measured at visit 3, after presentation of two neutral and two smoking scripts|||µS||Standard Deviation|Mean
794822|NCT00916721|Secondary|Change in Craving Level to Smoking Cues Caused by Smoking Cues, Measured Using Script Driven Imagery|"Craving level will be measured using a 8 point Visual Analogue Scale (VAS) of craving. Participants will be ask How much do you want a cigarette right now Participants will answer accordingly: 0=no desire at all; 7=unable to resist craving"|Craving level was measured at visit 3, after presentation of two neutral and two smoking scripts|||units on a scale||Standard Deviation|Mean
794823|NCT00916929|Secondary|Sensitivity|Sensitivity is defined as the ability of the algorithm to detect heart failure events. Sensitivity is calculated as the number of heart failure events detected by the algorithm (true positives) divided by the total number of heart failure events (true positives + false positives).|6-months|All patients enrolled in the study were included in this analysis with a total of 82 patients in each group. Of the 82 patients implanted with ICD, 2 were upgraded to CRT-D during data collection period. These 2 patients were censored from ICD cohort and included in CRT-D cohort at the time of upgrade based on as-treated analysis principle.||percentage of true positives||95% Confidence Interval|Number
794824|NCT00916929|Primary|False Positive Rate|False Positive Rate is the the number of departures from the device's programmed threshold that are unrelated to a heart failure event. The False Positive Rate per patient year of follow up should be less than 1.5.|6-months|All patients participating in the study were included in the analysis with a total of 82 patients in each arm. Of the 82 patients implanted with ICD, 2 were upgraded to CRT-D. These 2 patients were censored from the ICD cohort and included in the CRT-D cohort at the time of upgrade based on as-treated analysis principle resulting.||departures from device threshold||95% Confidence Interval|Number
794825|NCT00917124|Secondary|Evidence of Coma, Stupor, Cerebral Insult, Delirium, Ventilation Longer Than 24 Hours, Myocardial Infarction, Atrial Fibrillation, Dialysis, Reoperation for Bleeding, Infection, Hospital Stay > 7 Days||7 postoperative days|||participants|||Number
794826|NCT00917124|Primary|Difference in Incidence of Cognitive Impairment Between Groups. Change Between Preoperative and Postoperative Cognitive Function Was Assessed by Performing Standardized Neurocognitive Tests.|"The Mini-Mental State Examination (MMSE) total score is calculated by summing the item scores across several aspects of cognition. The maximum possible total score is 30 points.
Color Trials Test (CTT) measures sustained visual attention, visual scanning and graphomotor skills. The examiner records the length of time (in seconds) required by the patient to rapidly draw a line connecting the circles numbered 1 through 25 in consecutive order.
Grooved-Pegboard test (GP test) is manipulative dexterity test that contains twenty-five holes with randomly positioned slots and pegs which have a key along one side. Pegs must be rotated to match the hole before they can be inserted. The examiner records the time in seconds.
Cognitive impairment was defined as a decline in postoperative performance in one or more tests: decrease of MMSE score three points or more from baseline and decrease of one standard deviation or more in performance on CTT 1 and GP tests"|preoperative, 7 days postoperative|"3 participants in Control group did not perform control cognitive test- transferred to another hospital.
6 participants in INVOS group did not perform control cognitive test - transferred to another hospital n=4, declined to participate n=2"||participants|||Number
794827|NCT00917267|Secondary|Assessment of Event Rate of Treatment-emergent Hypoglycemic Events|Major hypoglycemia: any episode with symptoms consistent with hypoglycemia that resulted in loss of consciousness or seizure with prompt recovery in response to administration of glucagon or glucose OR documented hypoglycemia (blood glucose <3.0 mmol/L [54 mg/dL]) and required the assistance of another person. Minor hypoglycemia: any sign or symptom associated with hypoglycemia that is either self-treated by the patient or resolves on its own AND has a concurrent finger stick blood glucose <3.0 mmol/L (54 mg/dL) and not classified as major hypoglycemia. Event rate per subject year was calculated for each subject: (number of events observed from a subject/exposure from a subject)*365.25 where exposure = last post-baseline visit date - baseline visit date. Mean and Standard Error were then derived from ITT.|Baseline to Week 26|ITT Population.||events per subject-year||Standard Error|Mean
794828|NCT00917267|Secondary|Change in Blood Pressure From Baseline to Week 26|Change in systolic blood pressure and diastolic blood pressure from baseline to Week 26.|Baseline, Week 26|ITT Population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. Missing data at endpoint was not imputed.||mmHg||Standard Deviation|Mean
794829|NCT00917267|Secondary|Ratio of Triglycerides (TG) at Week 26 to Baseline|Ratio of TG (measured in mg/dL) at Week 26 to baseline. Log(Post-baseline TG) - log(Baseline TG); change from baseline to Week 26 is presented as ratio of Week 26 to baseline.|Baseline, Week 26|ITT Population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.||ratio||Standard Error|Least Squares Mean
794830|NCT00917267|Secondary|Change in High-Density Lipoprotein (HDL) From Baseline to Week 26|Change in HDL from baseline to Week 26.|Baseline, Week 26|ITT Population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.||mg/dL||Standard Error|Least Squares Mean
794832|NCT00917267|Secondary|Change in Body Weight (BW) From Baseline to Week 26|Change in BW from baseline to Week 26.|Baseline, Week 26|ITT Population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.||kg||Standard Error|Least Squares Mean
794833|NCT00917267|Secondary|Change in Fasting Serum Glucose (FSG) From Baseline to Week 26|Change in FSG from baseline to Week 26.|Baseline, Week 26|ITT Population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.||mg/dL||Standard Error|Least Squares Mean
794834|NCT00917267|Secondary|Percentage of Patients Achieving HbA1c Targets <=6.5% at Week 26|Percentage of patients achieving HbA1c <=6.5% at Week 26 (for patients with HbA1c >6.5% at baseline).|Baseline, Week 26|ITT Population. Only patients with baseline HbA1c > target were included in calculation. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. Missing data at endpoint was imputed using LOCF approach.||percentage of patients|||Number
794835|NCT00917267|Secondary|Percentage of Patients Achieving HbA1c Targets <=7% at Week 26|Percentage of patients achieving HbA1c <=7% at Week 26 (for patients with HbA1c >7% at baseline).|Baseline, Week 26|ITT Population. Only patients with baseline HbA1c > target were included in calculation. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. Missing data at endpoint was imputed using last observation carried forward (LOCF) approach.||percentage of patients|||Number
794836|NCT00917267|Primary|Change in HbA1c From Baseline to Week 26.|Change in HbA1c from baseline to Week 26.|Baseline, Week 26|ITT Population: Randomized patients received at least one dose of study drug. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.||percentage of total hemoglobin||Standard Error|Least Squares Mean
794837|NCT00917384|Secondary|Number of Participants Who Developed Antibodies Against IMC-1121B|The number of participants who developed treatment emergent antibody responses to IMC-1121B after baseline.|Baseline, 12 Weeks|Subset of the Safety Population: All randomized participants who received at least 1 dose of study drug and who had immunogenicity analysis performed.||participants|||Number
794838|NCT00917384|Secondary|Maximum Concentration (Cmax) of IMC-1121B|Cmax was not analyzed as only pre-dose samples were collected.|6 weeks post-randomization|Zero participants were analyzed.|||||
794839|NCT00917384|Secondary|Number of Participants With Adverse Events|Clinically significant events were defined as serious adverse events (SAE) and other treatment-emergent non-serious adverse events (NSAE). A summary of SAEs and all other NSAEs is located in the Reported Adverse Event module.|Randomization up to 18 months|Safety Population: All randomized participants who received at least 1 dose of study drug.||participants|||Number
794840|NCT00917384|Secondary|Change From Baseline in Quality of Life (QoL) as Measured by the European Organisation for Research and Treatment of Cancer Questionnaire (EORTC-QLQ-C30)|EORTC QLQ-C30 v3.0 is a self-administered questionnaire with multidimensional scales that measures 5 functional domains (physical, role, cognitive, emotional, and social), global health status, and symptom scales of fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties. A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For functional domains and global health status, higher scores represent a better level of functioning. For symptoms scales, higher scores represented a greater degree of symptoms. Best change from baseline results determined by Least Square (LS) mean estimated with randomization stratification factors and baseline value as continuous covariate.|Baseline up to Cycle 10 (18 weeks [1 cycle=2 weeks])|All randomized participants with EORTC QLQ-C30 values at baseline and any point up to 18 weeks post-baseline.||units on a scale||Standard Error|Least Squares Mean
794841|NCT00917384|Secondary|Duration of Response (DOR)|DOR is the interval from date of initial documented response (complete response [CR] or partial response [PR]) to first documented date of disease progression (PD) or death as a result of any cause. CR and PR were defined using the Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR is defined as the disappearance of all target and non-target lesions, no appearance of new lesions and confirmed at the consecutive tumor assessment. PR is defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, no appearance of new lesions and confirmed at a subsequent tumor assessment. Participants who did not relapse or die were censored at the time of the last adequate objective tumor assessment.|Randomization up to 17 months post-randomization|Zero participants were analyzed. The number of all responders (participants with CR or PR) was too small for a meaningful analysis, as specified in the statistical analysis plan.|||||
794842|NCT00917384|Secondary|Percentage of Participants With Objective Response (Objective Response Rate [ORR])|ORR is equal to the percentage of participants achieving a best overall response of complete response (CR) or partial response (PR). CR and PR were defined using the Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR is defined as the disappearance of all target and non-target lesions, no appearance of new lesions and confirmed at the consecutive tumor assessment. PR is defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, no appearance of new lesions and confirmed at a subsequent tumor assessment.|Randomization up to 17 months post-randomization|Intent-to-treat population: all randomized participants.||percentage of participants||95% Confidence Interval|Number
794843|NCT00917384|Secondary|Percentage of Participants Who Are Progression-Free at Week 12 (PFS Rate)|The percentage of participants alive and progression-free 12 weeks after randomization. Progression-free survival (PFS) is defined as the time from the date of randomization until the date of objectively determined progressive disease (PD) or death due to any cause whichever comes first. Participants alive and without PD were censored at the time of the last adequate objective tumor assessment.|Week 12 post-randomization|Intent-to-treat population: all randomized participants.||percentage of participants||95% Confidence Interval|Number
794844|NCT00917384|Secondary|Progression-Free Survival (PFS)|PFS is defined as the time from date of randomization until date of objectively determined progressive disease (PD) or death due to any cause, whichever is first. Participants alive and without PD were censored at the time of last adequate objective tumor assessment (that is, response other than unevaluable).|Randomization up to 17 months|Intent-to-treat population: all randomized participants. Censored participants: ramucirumab=39, placebo=9.||months||95% Confidence Interval|Median
794845|NCT00917384|Primary|Overall Survival (OS)|Overall survival is defined as the time from the date of randomization to the date of death from any cause. Participants who were alive at the date of data cut-off or who were lost to follow-up were censored on the last date the participant was known to be alive|Randomization up to 28 months post-randomization|Intent-to-treat population: all randomized participants. Censored participants: ramucirumab=59, placebo=18.||months||95% Confidence Interval|Median
794846|NCT00917501|Primary|Change From Baseline in Depression Symptom Severity at 12 Weeks|Change in Children’s Depression Rating Scale-revised (CDRS-R) Total Score from Baseline to 12 weeks CDRS-R score ranges from 17 (i.e., not depressed) to 113 (i.e., severe depression)|Baseline and 12 weeks|||Total score on CDRS-R||Standard Deviation|Mean
794847|NCT00917579|Secondary|Plasma Elimination Half-life (t1/2)|t1/2 = terminal elimination half-life in hours.|0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose|PK parameter analysis population: all subjects enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Only 73 subjects contributed to the PK analysis in the reference group as plasma concentrations for 1 subject were below the limit of quantification, with the exception of 1 time point.||hours||Standard Deviation|Mean
794848|NCT00917579|Secondary|Time to Reach Maximum Plasma Concentration (Tmax)|Tmax = time (hours) to maximum plasma concentration (Cmax).|0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose|PK parameter analysis population: all subjects enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Only 73 subjects contributed to the PK analysis in the reference group as plasma concentrations for 1 subject were below the limit of quantification, with the exception of 1 time point.||hours||Inter-Quartile Range|Median
794849|NCT00917579|Primary|Maximum Observed Plasma Concentration (Cmax)|Cmax = maximum observed plasma concentration. Measured in nanograms per milliter (ng/mL).|0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose|PK parameter analysis population: all subjects enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Only 73 subjects contributed to the PK analysis in the reference group as plasma concentrations for 1 subject were below the limit of quantification, with the exception of 1 time point.||ng/mL||Standard Deviation|Mean
794850|NCT00917579|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|AUClast = area under the plasma concentration-time curve from 0 (predose) to the time of the last measureable concentration (Clast); measured in nanograms times hour per milliliter (ng•hr/mL).|0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose|PK parameter analysis population: all subjects enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Only 73 subjects contributed to the PK analysis in the reference group as plasma concentrations for 1 subject were below the limit of quantification, with the exception of 1 time point.||ng•hr/mL||Standard Deviation|Mean
794851|NCT00917579|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC Infinity)|AUCinf = Area under the plasma concentration-time curve from time 0 (predose) extrapolated to infinite time; measured in nanograms times hour per milliliter (ng•hr/mL).|0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose|Pharmacokinetic (PK) parameter analysis population: all subjects enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Only 73 subjects contributed to the PK analysis in the reference group as plasma concentrations for 1 subject were below the limit of quantification, except 1 time point.||ng•hr/mL||Standard Deviation|Mean
794852|NCT00917644|Secondary|Plasma Elimination Half-life (t1/2)|t1/2 = terminal elimination half-life in hours; ln 2/kel, where kel is the termination phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression. PK parameters derived from subject's concentration data; collected Period 1, Day 1 to Day 4; Period 2, Day 1 to Day 4.|0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose|PK parameter analysis population||hours||Standard Deviation|Mean
794853|NCT00917644|Primary|Maximum Observed Plasma Concentration (Cmax)|Cmax = maximum observed plasma concentration. Measured in nanograms per milliter (ng/mL); collected Period 1, Day 1 to Day 4; Period 2, Day 1 to Day 4.|0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose|PK parameter analysis population||ng/mL||Standard Deviation|Mean
794854|NCT00917644|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|AUClast = area under the plasma concentration-time curve from 0 (predose) to the time of the last measureable concentration (Clast). PK parameters derived from subject's concentration data; collected Period 1, Day 1 to Day 4; Period 2, Day 1 to Day 4.|0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose|PK parameter analysis population||ng*hr/mL||Standard Deviation|Mean
794855|NCT00917644|Secondary|Time to Reach Maximum Plasma Concentration (Tmax)|Tmax = time (hours) to maximum plasma concentration (Cmax). Observed directly from data as time of first occurrence; PK parameters derived from subject's concentration data; collected Period 1, Day 1 to Day 4; Period 2, Day 1 to Day 4.|0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose|PK parameter analysis population||hours||Full Range|Median
794856|NCT00917644|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC Infinity)|AUCinf = Area under the plasma concentration-time curve from time 0 (predose) extrapolated to infinite time; measured in nanograms times hour per milliliter (ng*hr/mL). Pharmacokinetic (PK) parameters derived from subject's concentration data; collected Period 1, Day 1 to Day 4; Period 2, Day 1 to Day 4.|0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose|PK parameter analysis population defined as all subjects randomized and treated who had > = 1 of the parameters of primary interest in > = 1 treatment period.||ng*hr/mL||Standard Deviation|Mean
794857|NCT00917735|Primary|Circulating Concentrations of IGF Axis Proteins Including IGF-1 and IGFBP-3|Circulating levels of IGF-1 and IGFBP-3 were measured in fasting blood samples by ELISA method.|Baseline and month 12|Circulating concentrations of IGF axis proteins including insulin-like growth factor (IGF-1) and IGF binding protein 3 (IGFBP-3) at baseline and month 12||ng/ml||95% Confidence Interval|Geometric Mean
794876|NCT00920647|Primary|Clinically Significant ECG Findings at Any Time During the Study.|Electrocardiogram (ECG) parameters included: heart rate, sinus rhythm, atrial/ventricular hypertrophy, PR, QRS, QT and QTc intervals.|6 months|Abnormalities Any Time Post-baseline ITT Population||participants|||Number
794877|NCT00920647|Primary|Safety: Development of Anti-idursulfase Antibodies (Serum)||6 months|Development of antibodies post Baseline-ITT Population||participants|||Number
794858|NCT00917735|Primary|Circulating Concentrations of Reproductive Hormones Including Estrone, Estradiol, Androstenedione, Testosterone, and Sex Hormone Binding Globulin (SHBG)|Circulating levels of reproductive hormones including estrone, estradiol, androstenedione, testosterone and SHBG were measured in fasting blood samples by liquid chromatography/tandem mass spectrometry method.|Baseline and month 12|Circulating concentrations of reproductive hormones including estrone, estradiol, androstenedione, testosterone, sex hormone binding globulin (SHBG) at baseline and month 12||pg/ml||95% Confidence Interval|Geometric Mean
794859|NCT00917735|Primary|Mammographic Density|Percent mammographic density was measured on digital images using a computer-assisted and quantitative method.|Baseline and month 12|Mammographic density at baseline and month 12||Percent||95% Confidence Interval|Geometric Mean
794860|NCT00917852|Primary|Major Device Events|Major device events requiring reintervention through 1 month study window. Possible device events include but are not limited to endoleak, migration, wire fracture, compression, erosion, extrusion, aortic dilatation, endograft infection, and aortic rupture.|1 month post-treatment|||Participants|||Count of Participants
794861|NCT00917852|Primary|All Cause Mortality||30 days post-treatment|All enrolled subjects||participants|||Number
794862|NCT00917865|Secondary|Mean SUVmax of Low Versus High Gleason Groups|To determine id radiotracer uptake correlates with gleason score|4 minutes,16 minutes,28 minutes and 40 minutes|||Mean SUV max||Standard Deviation|Mean
794863|NCT00917865|Primary|Diagnostic Performance Per Sextant at Each Time Point by Visual Analysis|"Each of 12 sextants per prostate (for a total of 120 sextants for the 10 patients) were analyzed separately at 4, 16, 28 and 40 min post-injection for the presence or absence of focal activity suspicious for tumor.
Sensitivity: Proportion of people with a disease who have a positive test result
Specificity: The proportion of people without disease who have a negative test result Positive Predictive Value (PPV):The probability that a person who has a positive test result has the disease for which the test was conducted.
Negative Predictive Value (NPV): The probability that a person who has a negative test result does not have the disease for which the test was conducted
Accuracy: Ability of the test to differentiate between disease and non-disease.
Note: 'n=' is the denominator used to compute each parameter."|At 4, 16, 28 and 40 minutes post-injection of FACBC|The number of participants for analysis was based on the protocol.Each prostate was divided into 12 sextants and then each sextant was visualized for abnormal focal uptake.The SUVmax for the malignant sextants were compared to that of the benign sextants. Note: 'n=' is the denominator used to compute each parameter.||Percentage of Sextants|Participants|95% Confidence Interval|Number
794864|NCT00920621|Secondary|Mass Spec Vitamin D Value From Cord Blood at Delivery|Mass Spec Vitamin D value from cord blood at delivery|Blood collection at delivery|Some measures have missing data due to collection, technical, and processing issues.||ng/mL||Standard Deviation|Mean
794865|NCT00920621|Secondary|Any Allergic Sensitization in the Child's First 3 Years of Life.|"Any allergic sensitization in the child's first 3 years of life.
*For some variables the negative count incorporates negative and indeterminate."|Child's first 3 years of life.|Some measures have missing data due to collection, technical, and processing issues.||Participants|||Count of Participants
794866|NCT00920621|Secondary|Child Serum 25-hydroxyvitamin D Measurement From Blood Collection at 3 Year Visit.|Child serum 25-hydroxyvitamin D measurement from blood collection at 3 year visit.|Blood collection at childs' 3 year visit.|Some measures have missing data due to collection, technical, and processing issues.||ng/mL||Standard Deviation|Mean
794867|NCT00920621|Secondary|Parental Report of Physician Diagnosis of Lower Respiratory Tract Infection in the Child's First 3 Years of Life.|Parental report of physician diagnosis of lower resperatory tract infection (LRI) in the child's first 3 years of life. LRI defined as physician diagnosed bronchitis, bronchiolitis, croup, or pneumonia ascertained from questionnaires administered every 3 months.|Child's first 3 years of life.|Some measures have missing data due to collection, technical, and processing issues.||Number of lower respiratory infections|||Number
794868|NCT00920621|Secondary|Parental Report of Physician Diagnosed Eczema (With Rash) in the Child's First 3 Years of Life.|"Parental report of physician diagnosis of eczema with rash in typical distribution in the child's first 3 years of life ascertained from questionnaires administered every 3 months.
*For some variables the negative count incorporates negative and indeterminate."|Child's first 3 years of life.|Some measures have missing data due to collection, technical, and processing issues.||Participants|||Count of Participants
794869|NCT00920621|Secondary|Child Serum 25-hydroxyvitamin D Measurement From Blood Collection at 1 Year Visit.|Child serum 25-hydroxyvitamin D measurement from blood collection at 1 year visit.|1 year visit|Some measures have missing data due to collection, technical, and processing issues.||ng/mL||Standard Deviation|Mean
794870|NCT00920621|Secondary|Child Positive-specific IgE Tests From Blood Collection at 3 Year Visit.|Child positive-specific IgE tests from blood collection at 3 year visit.|3 years|Some measures have missing data due to collection, technical, and processing issues.||Positive-specific IgE tests|completed tests||Number
794871|NCT00920621|Primary|Achieved Maternal 25(OH)D Level of ≥ 30 ng/mL at Third Trimester Sampling.|Maternal serum 25-hydroxyvitamin D measurement at third trimester during pregnancy|32-38 weeks gestation|Some measures have missing data due to collection, technical, and processing issues.||Participants|||Count of Participants
794872|NCT00920621|Primary|Asthma or Recurrent Wheeze in First 3 Years of Life|"Parental report of physician diagnosis of asthma or occurrence of recurrent wheeze in the child's first 3 years of life ascertained from questionnaires administered every 3 months.
*For some variables the negative count incorporates negative and indeterminate."|First 3 years of life.|Some measures have missing data due to collection, technical, and processing issues.||Participants|||Count of Participants
794873|NCT00920647|Secondary|% Change From Baseline in Urinary GAG||Baseline to Week 27|||% Change||Standard Error|Mean
794874|NCT00920647|Secondary|Concentration of Idursulfase in Serum After Repeated Doses of Intrathecal Idursulfase-IT Given in Conjunction With Elaprase||Weeks 23|Only 1 patient out of 4 in the 1mg dose yielded sufficient data to calculate AUC.||min*ng/mL||Standard Deviation|Mean
794875|NCT00920647|Secondary|Concentration of Idursulfase in Serum After Single Administration (Week 3) in Conjunction With Elaprase|Values below lower limit of quantitation (LLOQ) are listed as 0.|Weeks 3|"Data were not available for the calculations in the patients of 1 mg idursulfase-IT group at Week 3.
Serum samples were not obtained from one patient in the 30mg Idursulfase-IT group at Week 3 after IV and IT administration."||min*ng/mL||Standard Deviation|Mean
794879|NCT00920647|Primary|Safety Changes in Cerebrospinal Fluid (CSF)- White Blood Cells (WBC)|White blood cell count in CSF was monitored throughout the study as a way of assessing any potential inflammation of the meninges induced by idursulfase-IT.|6 months|Abnormalities Any Time Post-baseline ITT Population||events|||Number
794880|NCT00920647|Primary|Number of Treatment Emergent Adverse Event (AE)|ITT patient population|Baseline to week 23|||events|||Number
794881|NCT00920647|Secondary|Level of Idursulfase in the CSF Compartment Resulting From Monthly Idursulfase IT Administrations|Samples collected from patients treated at doses of 1 mg and 30 mg, as well as the control group, were below the lower limit of detection of the bioanalytical method (3.13 ng/mL)|Week 27 (end of study)|||ng/mL||Standard Deviation|Mean
794882|NCT00920647|Secondary|Change From Baseline in CSF Glycosaminoglycans [GAGs] at Week 27|Percent Change from Baseline to Week 27|Baseline to Week 27|||% change||Standard Error|Mean
794883|NCT00920647|Primary|Number of Serious Adverse Event (SAE)||6 months|Abnormalities Any Time Post-baseline ITT Population||events|||Number
794884|NCT00920686|Secondary|24 Hours Post Administration - Incidence of Complete Headache Relief, Photophobia, Phonophobia and Nausea|"Complete headache relief is defined as reduction of headache severity from moderate or severe to absent.
Presence of Photophobia and Phonophobia measured on a 2-point scale: 0 = absent; 1 = present
Nausea was measured on a 4-point scale: 0 = no nausea; 1 = mild nausea; 2 = moderate nausea; 3 = severe nausea"|24 hours|Number of subjects with headache relief at 24 hours.||Participants|||Number
794885|NCT00920686|Secondary|4 Hours Post Administration - Incidence of Complete Headache Relief, Photophobia, Phonophobia and Nausea|"Complete headache relief is defined as reduction of headache severity from moderate or severe to absent.
Presence of Photophobia and Phonophobia measured on a 2-point scale: 0 = absent; 1 = present
Nausea was measured on a 4-point scale: 0 = no nausea; 1 = mild nausea; 2 = moderate nausea; 3 = severe nausea"|4 hours|Number of subjects with headache relief at 4 hours.||Participants|||Number
794886|NCT00920686|Secondary|2 Hours Post Administration - Incidence of Complete Headache Relief, Photophobia, Phonophobia and Nausea|"Complete headache relief is defined as reduction of headache severity from moderate or severe to absent.
Presence of Photophobia and Phonophobia measured on a 2-point scale: 0 = absent; 1 = present
Nausea was measured on a 4-point scale: 0 = no nausea; 1 = mild nausea; 2 = moderate nausea; 3 = severe nausea"|2 hours|Number of subjects with headache relief at 2 hours.||Participants|||Number
794887|NCT00920686|Secondary|Headache Relief and Recurrence (Observed Cases)|"Headache relief is defined as a ≥ 1-point reduction from baseline in Headache Severity Score. The Headache Severity Score is a four-point scale: 0=no pain; 1 = mild pain; 2 = moderate pain; and 3 = severe pain.
Headache recurrence is defined as any subject that experiences headache relief within 4 hours, who did not use rescue medication, and who experienced a worsening of their headache to moderate or severe within 24 hours following study drug administration."|2, 4 and up to 24 hours|Number of subjects who experienced headache relief within 4 hours||percentage of participants|||Number
794888|NCT00920686|Primary|Time (Hours) to First Use of Rescue Medication||24 hours|The Full Analysis Set included all those subjects randomized who had dosed with study drug and had at least one (1) post study drug administration observation for headache severity. The Efficacy Evaluable Analysis Set, included all subjects with an imputed (LOCF) HSS at both the 2 hour time point and the 4 hour time point.||hours||Inter-Quartile Range|Median
794889|NCT00920699|Secondary|CoQ10 Levels|ng/ml|change from baseline to 20 weeks|data was not available for all participants to compare baseline to 20 weeks||ng/ml||Standard Deviation|Mean
794890|NCT00920699|Secondary|8OHdG Levels|ng/ml. Negative value signifies an decrease in 8OHdG levels|change from baseline to 20 weeks|Lab data not available for all participants to compare baseline and 20 weeks||ng/ml||Standard Deviation|Mean
794891|NCT00920699|Primary|Tolerability as Assessed by Ability to Complete the Study on the Originally Randomized Treatment Assignment.|No dosage modifications, reported as a %|20 weeks|||percentage of participants|||Number
794892|NCT00920790|Primary|Pharmacokinetics-Plasma KW-0761 Concentrations (t1/2)||0 to 28 days post final dose and follow-up examinations (1 month and 3 months after the end of the post-dosing observation period).|Of the 27 subjects enrolled, 27 were included in the pharmacokinetics analysis set.||hours||Standard Deviation|Mean
794893|NCT00920790|Primary|Pharmacokinetics-Plasma KW-0761 Concentrations (AUC0-7days)|Statistics of plasma KW-0761 concentrations were tabulated. Individual and mean (+standard deviation) plasma KW-0761 concentrations were plotted on a linear and a logarithmic scale against the time of blood sampling.|0 to 7 days post final dose|Of the 27 subjects enrolled, 27 were included in the pharmacokinetics analysis set.||ng·h/mL||Standard Deviation|Mean
794894|NCT00920790|Primary|Pharmacokinetics-Plasma KW-0761 Concentrations|"Statistics of plasma KW-0761 concentrations were tabulated. Individual and mean (+standard deviation) plasma KW-0761 concentrations were plotted on a linear and a logarithmic scale against the time of blood sampling.
The baseline and maximum time point at which Cmax and Ctrough were collected are 0 to 7 days post-dose."|0 to 7 days post final dose|Of the 27 subjects enrolled, 27 were included in the pharmacokinetics analysis set.||ng/mL||Standard Deviation|Mean
794895|NCT00920790|Secondary|Overall Survival (OS)|The time from the date of first KW-0761 dosing to the date of death.|Baseline to response|Of the 27 subjects enrolled, 26 were included in the overall survival analysis set, whereas 1 was excluded.||days||Full Range|Median
794896|NCT00920790|Secondary|Progression Free Survival (PFS)|"The time from the date of first KW-0761 dosing to the date of progressive disease(PD) confirmation or death.
The antitumor response criteria including PD were created based on the criteria for non-Hodgkin's lymphoma and chronic lymphocytic leukemia provided in the National Comprehensive Cancer Network(NCCN) Clinical Practice Guidelines in Oncology as well as the criteria for non-Hodgkin's lymphoma by the Lymphoma Study Group of the Japan Clinical Oncology Group (JCOG-LSG)."|Baseline to response|Of the 27 subjects enrolled, 26 were included in the efficacy analysis set, whereas 1 was excluded.||days||Full Range|Median
794921|NCT00920855|Secondary|Percentage of Participants With An Overall Tumor Response As Assessed By the Investigator|Overall tumor response is the sum of a complete response (CR), very good partial response (VGPR), partial response (PR) and minimal response (MR). A modified version of the Bladé criteria for response was used. Abbreviated definitions for the response categories can be found in the description of outcome #3.|Up to 7.5 months (eight 28-day cycles)|Efficacy population||percentage of participants||95% Confidence Interval|Number
794897|NCT00920790|Primary|Overall Response Rate (ORR)|"Response rate defined as the proportion of responders relative to the total population and its exact 95% confidence interval were calculated for best overall response.
The antitumor response criteria (Complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD)) were created based on the criteria for non-Hodgkin’s lymphoma and chronic lymphocytic leukemia provided in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology as well as the criteria for non-Hodgkin’s lymphoma by the Lymphoma Study Group of the Japan Clinical Oncology Group (JCOG-LSG).Overall Response (OR)= CR + PR."|From date of first subject's consent to participate in the study until the date of last protocol-specified examination for last subject completed, assessed up to 14 months.|Of the 27 subjects enrolled, 26 were included in the efficacy analysis set, whereas 1 was excluded.||percentage of participants with response||95% Confidence Interval|Number
794898|NCT00920816|Other Pre-specified|Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0: worst imaginable health state to 100: best imaginable health state; higher scores indicate a better health state.|Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C21, end of treatment (up to Week 103), follow-up (28 days after last dose)|FAS previously-treated Asian population. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies those participants evaluated for this measure at specific time point for each group respectively.||units on a scale||Standard Deviation|Mean
794899|NCT00920816|Other Pre-specified|Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0: worst imaginable health state to 100: best imaginable health state; higher scores indicate a better health state.|Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C23, end of treatment (up to Week 107), follow-up (28 days after last dose)|FAS treatment-naive population. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies those participants evaluated for this measure at specific time point for each group respectively.||units on a scale||Standard Deviation|Mean
794900|NCT00920816|Other Pre-specified|Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C21, end of treatment (up to Week 103), follow-up (28 days after last dose)|FAS previously-treated Asian population. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies those participants evaluated for this measure at specific time point for each group respectively.||units on a scale||Standard Deviation|Mean
794901|NCT00920816|Other Pre-specified|Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C23, end of treatment (up to Week 107), follow-up (28 days after last dose)|FAS treatment-naive population. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies those participants evaluated for this measure at specific time point for each group respectively.||units on a scale||Standard Deviation|Mean
794902|NCT00920816|Other Pre-specified|Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants|FKSI-DRS: subset of FKSI which is FACT–Kidney Symptom Index questionnaire used to assess QoL for participants diagnosed with renal cell cancer. FKSI contains 15 questions and FKSI-DRS 9 questions (lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, hematuria) each ranging from 0 (not at all) to 4 (very much). FKSI-DRS total score 0 to 36; higher scores associated with better health states (Individual questions may be reversed coded, as appropriate).|Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C21, end of treatment (up to Week 103), follow-up (28 days after last dose)|FAS previously-treated Asian population. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies those participants evaluated for this measure at specific time point for each group respectively.||units on a scale||Standard Deviation|Mean
794903|NCT00920816|Other Pre-specified|Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants|FKSI-DRS: subset of FKSI which is FACT–Kidney Symptom Index questionnaire used to assess QoL for participants diagnosed with renal cell cancer. FKSI contains 15 questions and FKSI-DRS 9 questions (lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, hematuria) each ranging from 0 (not at all) to 4 (very much). FKSI-DRS total score 0 to 36; higher scores associated with better health states (Individual questions may be reversed coded, as appropriate).|Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C23, end of treatment (up to Week 107), follow-up (28 days after last dose)|FAS treatment-naive population. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies those participants evaluated for this measure at specific time point for each group respectively.||units on a scale||Standard Deviation|Mean
794904|NCT00920816|Other Pre-specified|Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants|FKSI-15 questionnaires (lack of energy, side effects, pain, weight loss, bone pain, fatigue, enjoying life, short of breath, worsened condition, appetite, coughing, bothered by fevers, ability to work, hematuria, sleep) was used to assess quality of life (QoL) for those diagnosed with renal cell cancer. Questions answered on 5-point Likert scale: 0 to 4 (0= not at all, 1= little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI score 0 to 60; higher scores=better health states (Individual questions may be reversed coded, as appropriate).|Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C21, end of treatment (up to Week 103), follow-up (28 days after last dose)|FAS previously-treated Asian population. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies those participants evaluated for this measure at specific time point for each group respectively.||units on a scale||Standard Deviation|Mean
794905|NCT00920816|Other Pre-specified|Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants|FKSI-15 questionnaires (lack of energy, side effects, pain, weight loss, bone pain, fatigue, enjoying life, short of breath, worsened condition, appetite, coughing, bothered by fevers, ability to work, hematuria, sleep) was used to assess quality of life (QoL) for those diagnosed with renal cell cancer. Questions answered on 5-point Likert scale: 0 to 4 (0= not at all, 1= little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI score 0 to 60; higher scores=better health states (Individual questions may be reversed coded, as appropriate).|Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C23, end of treatment (up to Week 107), follow-up (28 days after last dose)|FAS treatment-naive population. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies those participants evaluated for this measure at specific time point for each group respectively.||units on a scale||Standard Deviation|Mean
794906|NCT00920816|Secondary|Overall Survival (OS): Second-Line Participants|Time in months from date of randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Baseline until death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103)|FAS included all previously-treated Asian participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.||months||95% Confidence Interval|Median
794907|NCT00920816|Secondary|Overall Survival (OS): First-Line Participants|Time in months from date of randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Baseline until death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107)|FAS included all treatment-naive participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.||months||95% Confidence Interval|Median
794908|NCT00920816|Secondary|Duration of Response (DR): Second-Line Participants|Time in months from the first documentation of objective tumor response that is subsequently confirmed to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103)|DR was calculated for the subgroup of participants from the FAS previously-treated population, with a confirmed objective tumor response (CR or PR).||months||95% Confidence Interval|Median
794909|NCT00920816|Secondary|Duration of Response (DR): First-Line Participants|Time in months from the first documentation of objective tumor response that is subsequently confirmed to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107)|DR was calculated for the subgroup of participants from the FAS treatment-naive population, with a confirmed objective tumor response (CR or PR).||months||95% Confidence Interval|Median
794910|NCT00920816|Secondary|Percentage of Participants With Objective Response (OR): Second-Line Participants|Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.|Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103)|FAS included all previously-treated Asian participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.||percentage of participants||95% Confidence Interval|Number
794922|NCT00920855|Primary|Participants With Dose Limiting Toxicity (DLT)|"Maximum tolerated dose was the dose that was 1 step lower than the dose where at least one third of patients experienced DLT. A DLT was defined as any of the following occurring during the first cycle:
grade 4 hematologic toxicity without regard for relationship to study drug treatment
thrombocytopenia grade 3 with grade 3 or grade 4 hemorrhage
grade 3 febrile neutropenia
grade 3 or grade 4 nausea and vomiting refractory to anti emetic therapy
any study drug related grade 3 or grade 4 nonhematologic toxicity
any drug related death
Toxicity grades (3=severe AE and 4=life-threatening or disabling AE) were assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3."|Day 1 - 28|Safety population||participants|||Number
794911|NCT00920816|Secondary|Percentage of Participants With Objective Response (OR): First-Line Participants|Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.|Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107)|FAS included all treatment-naive participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.||percentage of participants||95% Confidence Interval|Number
794912|NCT00920816|Primary|Progression Free Survival (PFS): Second-Line Participants|"Time in months from randomization to first documentation of objective tumor progression or death due to any cause. PFS calculated as (first event date minus date of randomization plus 1)/30.4. Tumor progression determined from oncologic assessment data (where it meets criteria for progressive disease [PD]), or from adverse event (AE) data (where outcome was Death). Progression using Response Evaluation Criteria in Solid Tumors (RECIST) is >= 20 percent (%) increase in sum of longest diameter of target lesions; measurable increase in non-target lesion; appearance of new lesions."|Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103)|FAS included all previously-treated Asian participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.||months||95% Confidence Interval|Median
794913|NCT00920816|Primary|Progression Free Survival (PFS): First-Line Participants|"Time in months from randomization to first documentation of objective tumor progression or death due to any cause. PFS calculated as (first event date minus date of randomization plus 1)/30.4. Tumor progression determined from oncologic assessment data (where it meets criteria for progressive disease [PD]), or from adverse event (AE) data (where outcome was Death). Progression using Response Evaluation Criteria in Solid Tumors (RECIST) is >= 20 percent (%) increase in sum of longest diameter of target lesions; measurable increase in non-target lesion; appearance of new lesions."|Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107)|Full analysis set (FAS) included all treatment-naive participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.||months||95% Confidence Interval|Median
794914|NCT00920855|Secondary|Summary of Participants With Adverse Events (AEs)|Counts of participants who had AEs are summarized in a variety of categories. Severity and relatedness to study drug are in the opinion of the investigator according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0. Severity is rated on a 5-point scale: 1=mild, 2=moderate, 3=severe, 4=life threatening or disabling, and 5= death related to AE. Relatedness is assessed on a 5-point scale: not related, unlikely, possible, probable and definite. Definite, probable and possible answers are reported as 'related' to study medication. Deaths are reported up to 18 months. All the deaths occurred beyond the treatment-emergent timeframe since they occurred 6.5-16 months after the final dosing. All other parts of the summary represent the treatment-emergent timeframe (up to 8.5 months) which is the treatment period plus 30 days.|up to 8.5 months. Deaths are reported up to 18 months|Safety population||participants|||Number
794915|NCT00920855|Secondary|Kaplan-Meier Estimate for Overall Survival (OS)|Overall survival is defined as the time from initiation of therapy to death from any cause or last follow-up visit.|up to 23 months|Safety population||months||95% Confidence Interval|Median
794916|NCT00920855|Secondary|Kaplan-Meier Estimate for Duration of Response|Duration of response (DR) is defined as the time from the first response to progressive disease (PD). See outcome #4 for a PD definition.|up to 8.5 months|Participants who had a response||months||95% Confidence Interval|Median
794917|NCT00920855|Secondary|Time to the First Response|Time to first response is defined as the time from the initiation of therapy to the first evidence of a confirmed response (ie, CR, VGPR, PR, or MR).|up to 8.5 months|Participants who had a response||months||Standard Deviation|Mean
794918|NCT00920855|Secondary|Kaplan-Meier Estimate for Progression-Free Survival|Progression free survival is the time between the date of initiation of therapy to progressive disease (PD) or death from any cause, whichever occurs first. See outcome #4 for a definition of PD.|up to 23 months|Safety population||months||95% Confidence Interval|Median
794919|NCT00920855|Secondary|Kaplan-Meier Estimate for Time to Progression (TTP)|"Time to progression was defined as the time from initiation of therapy to progressive disease (PD). PD requires at least one of the following:
>25% increase in serum monoclonal paraprotein (which must also be an absolute increase of at least 5 g/L),
>25% increase in 24-hour urinary light chain excretion (which must also be an absolute increase of at least 200 mg/24 h),
>25% increase in plasma cells in a bone marrow aspirate or on trephine biopsy (which must also be an absolute increase of at least 10%),
definite increase in the size of existing lytic bone lesions or soft tissue plasmacytomas,
the development of new bone lesions or soft tissue plasmacytomas,
the development of hypercalcemia (corrected serum calcium > 11.5 mg/dL or 2.8 mmol/L not attributable to any other cause)."|up to 8.6 months|Safety population||months||95% Confidence Interval|Median
794920|NCT00920855|Secondary|Participants' Best Tumor Response as Assessed by the Investigator|Abbreviated criteria for response categories: CR includes the disappearance of the original monoclonal protein (M-protein) from blood and urine, and <5% plasma cells in the bone marrow, and no increase in size/number of lytic bone lesions, and disappearance of soft tissue plasmacytomas for >=4 weeks. VGPR includes serum and urine M-protein detectable by immunofixation but not electrophoresis, and reduction in 24-hr urinary light chain excretion by <100 mg, and disappearance of soft tissue plasmacytomas for >= 4 weeks, and no increase in size/number of lytic bone lesions. PR includes a >=50% reduction in serum M-protein, and reduction in 24-hr urinary light chain excretion by either >=90% or to <200 mg, and >=50% reduction in size of soft tissue plasmacytomas, and no increase in size/number of lytic bone lesions. MR includes a >=25% and <=49% reduction in serum M-protein. SD does not meet criteria for the other response categories. See outcome #4 for a definition of PD.|up to 7.5 months (eight 28-day cycles)|Efficacy population||participants|||Number
794923|NCT00920907|Secondary|Number of Participants With 2-Grade or Greater Shift From Baseline (Worsening) in Electrolyte Laboratory Safety Tests - All Treated Participants|Sodium high (H) Gr 1:>ULN - 150; Gr 2: >150 – 155; Gr 3: >155 – 160; Gr 4: >160 mmol/L; Sodium low(L) Gr 1:<LLN – 130; Gr 3: <130 – 120; Gr 4: <120 mmol/L. Potassium (H) Gr 1: >ULN – 5.5; Gr 2: >5.5 – 6.0; Gr 3: > 6.0 – 7.0; Gr 4: >7.0 mmol/L; Potassium (L) Gr 1: <LLN – 3.0; Gr 2: <LLN – 3.0; Gr 3: < 3.0 – 2.5; Gr 4: <2.5 mmol/L. Bicarbonate Gr1: 16-<LLN, Gr2: 11-16, Gr3, 8-11, Gr4: <8 milliequivalents per liter (mEq/L). Phosphorus Gr 1: 2.5 - <LLN, Gr2 2.0-<2.5, Gr3: 1.0-<2.0, Gr4: <1.0. Calcium (L) Gr 1: <LLN to 8.0; Gr2: 7.0 – 8.0; Gr3: 6.0-7.0; Gr 4: <6.0 mg/dL; calcium (H) Gr1:>ULN – 11.5, Gr2:>11.5 – 12.5, Gr3: 12.5 – 13.5, Gr4: >13.5. Baseline is screening or Day 1, prior to first dose of drug.|Screening to data cut off for July 2010, approximately 36 Weeks|All participants who received at least 1 dose of ipilimumab and had available data at baseline and post baseline.||participants|||Number
794924|NCT00920907|Secondary|Number of Participants With 2-Grade or Greater Shift From Baseline (Worsening) in Chemistry Laboratory Safety Tests (Non-electrolyte) - All Treated Participants|Alanine transaminase (ALT); Aspartate aminotransferase (AST); Alkaline phosphatase (ALP); upper limits of normal (ULN). ALT Gr 1:>1.0 to 2.5*ULN; Gr 2: >2.5 to 5.0*ULN; Gr 3: >5.0 to 20.0*ULN; Gr 4: >20.0*ULN. AST Gr 1: >1.0 to 2.5*ULN; Gr 2: >2.5 to 5.0*ULN; Gr 3: >5.0 to 20.0*ULN; Gr 4: >20.0*ULN. Total bilirubin Gr 1: >1.0 to 1.5*ULN; Gr 2: >1.5 to 3.0*ULN; Gr 3: >3.0 to 10..0*ULN; Gr 4: >10.0.0*ULN. ALP (U/L) Gr1:>1.0 to 2.5*ULN, Gr2:>2.5 to 5.0*ULN, Gr3:>5.0 to 20.0*ULN, Gr4:>20.0*ULN. Albumin (low) Gr 1:<LLN to 3 g/dL; Gr 2: <3.0 – 2.0 g/L; Gr 3: < 2 g/dL. Creatinine Gr 1: >1 – 1.5*ULN; Gr 2: >1.5 – 3.0*ULN; Gr 3: >3.0– 6.0*ULN; Gr 4: >6.0*ULN. Lipase (U/L) Gr 1: 1.0 to 1.5*ULN; Gr 2: >1.5 to 2.0*ULN; Gr 3: 2.0 to 5; Gr 4: >5*ULN. Amylase (U/L) Gr 1: >ULN to 1.5*ULN; Grade 2 >1.5 to 2.0*ULN, Grade 3 >2.0 to 5.0*ULN, Grade 4 >5.0*ULN. Baseline was screening or Day 1, prior to first dose of drug.|Screening to data cut off for July 2010, approximately 36 Weeks|All participants who received at least 1 dose of ipilimumab and had available data at baseline and post baseline.||participants|||Number
794925|NCT00920907|Secondary|Number of Participants With 2-Grade or Greater Shift From Baseline (Worsening) in Hematology Laboratory Safety Tests - All Treated Participants|Common Terminology Criteria (CTC), Version 3 used to assess parameters. Lower limit of normal (LLN); grams per deciliter (g/dL); Grade (GR); cells per microliter (c/µL). Hemoglobin Gr 1:<LLN to 10.0 g/dL, Gr 2:<10.0 to 8.0 g/dL, Gr 3:<8.0 to 6.5 g/dL, Gr 4:<6.5 g/dL. Absolute neutrophil (ANC) and ANC plus bands: Gr 1:<LLN to 1.5*10^3 c/µL, Gr 2:<1.5 to 1.0*10^3 c/µL, Gr 3:<1.0 to 0.5*10^3 c/µL, Gr 4:<0.5*10^3 c/µL. Platelet count Gr 1:LLN to 75.0*10^9 c/L, Gr 2:<75.0 to 50.0*10^9 c/L, Gr 3:<50.0 to 25.0*10^9 c/L, Gr 4:<25.0 to 10^9 c/L. Lymphocytes Gr 1: <1.5 to 0.8 *10^3 c/µL, Gr 2 <0.8 to 0.5 *10^3 c/µL, Gr 3: <0.5 to 0.2 *10^3 c/µL, Gr 4: <0.2*10^3 c/µL. Leukocytes Gr 1:<LLN to 3.0 *10^3 c/µL, Gr 2; <3.0 to 2.0 *10^3 c/µL, Gr 3: <2.0 to 1.0 *10^3 c/µL, Gr 4: <1.0 *10^3 c/µL. Baseline is screening or Day 1, prior to dosing.|Screening to data cut off for July 2010, approximately 36 Weeks|All participants who received at least 1 dose of ipilimumab and had available data at baseline and post baseline.||participants|||Number
794926|NCT00920907|Secondary|Mean Change From Baseline in Sitting Pulse Rate - All Treated Participants up to Data Cutoff|Pulse Rate was measured in beats per minute (bpm) and was obtained after the participant had been seated for 5 minutes. Vital sign measurements were collected at Screening (baseline), Weeks 1, 4, 7, 10, 12, 24 and every 12 weeks thereafter in the Maintenance Phase, and at the End of Treatment visit. The change from baseline in blood pressure one hour post end of infusion at the end of induction Period, Week 36 of Maintenance Period, and end of treatment, up to data cutoff for July 2010 are presented below.|Screening to data cut off for July 2010, approximately 36 Weeks|All participants who received at least 1 dose of ipilimumab and had available data at baseline and the specific timepoint.||bpm||Standard Deviation|Mean
794927|NCT00920907|Secondary|Mean Change From Baseline in Sitting Systolic and Diastolic Blood Pressure - All Treated Participants up to Data Cutoff|Systolic and Diastolic blood pressure were measured in millimeters of mercury (mmHg) and were obtained after the participant had been seated for 5 minutes. Vital sign measurements were collected at Screening (baseline), Weeks 1, 4, 7, 10, 12, 24 and every 12 weeks thereafter in the Maintenance Phase, and at the End of Treatment visit. The change from baseline in blood pressure one hour post end of infusion at the end of induction Period, Week 36 of Maintenance Period, and end of treatment, up to data cutoff for July 2010 are presented below.|Screening to data cut off for July 2010, approximately 36 Weeks|All participants who received at least 1 dose of ipilimumab and had available data at baseline and the specific timepoint.||mmHg||Standard Deviation|Mean
794928|NCT00920907|Secondary|Number of Participants Who Developed Antibodies and Neutralizing Antibodies|Electrochemiluminescent (ECL) Immunoassay was used to detect human anti-human ipilimumab antibodies (HAHA) in serum. Blood samples were collected prior to the start of each ipilimumab infusion at Weeks 1, 4, 7, 10, 24, and at end of treatment. Those participants who were positive HAHA on treatment were then tested for presence of neutralizing antibodies.|Prior to start of drug Week 1 to Week 24 on treatment or end of treatment|Participants who received study drug and had HAHA data prior to infusion in Week 1 and while on treatment.||participants|||Number
794929|NCT00920907|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation|Adverse events (AEs) and Serious AEs (SAEs) were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse events version 3.0. Medical Dictionary for Regulatory Activities (MedDRA) version 15.1 was used. Note there is a difference in number of participants with an SAE in this outcome measure and the number listed in the Adverse Events Section of this document. This is because the SAEs reported in the xml upload of the Adverse Events section includes additional participants who reported SAEs after the clinical study report database was closed.|Day 1 to last patient, last visit, approximately 3 years|All participants who received at least 1 dose of ipilimumab.||participants|||Number
794930|NCT00920907|Secondary|Model Estimates of Mean Absolute Lymphocyte Count at Each Nominal Ipilimumab Induction Dose and at End of the Induction Dosing Period|Absolute lymphocyte counts (ALC) were obtained throughout the study as part of the hematology panel. Results collected from 28 days prior to the first infusion of ipilimumab through the end of the Induction-Dosing Period were included in the analyses of ALC. Mean ALC was estimated via an extended linear model, with linear splines and a spatial exponential within-patient correlation structure. Lymphocytes were measured as 1000 cells per micro liter (c/µL).|Day 0 (prior to first dose) to Day 84|All participants in the Pharmacodynamic data set with: (1) a baseline ALC evaluation; and (2) at least 1 post-baseline ALC evaluation (after the date of first dose).||1000 c/µL||95% Confidence Interval|Mean
794931|NCT00920907|Secondary|Median Overall Survival Following First Ipilimumab Dose - All Treated Participants|Overall survival (OS) was defined as the time between the first dose of study treatment and death and was analyzed using Kaplan-Meier methods, with participants who had not died censored at the last date known to be alive. Overall survival was measured in months.|Week 1 (first dose) to last patient, last visit, approximately 3 years|All participants who received at least one dose of ipilimumab.||months||95% Confidence Interval|Median
794932|NCT00920907|Secondary|Best Overall Tumor Response Per Investigator Based on Immune-related (ir) Response Criteria (RC) - All Randomized Participants|ir RC=modifications of mWHO criteria reflecting clinical experience with ipilimumab in over 20 completed and/or ongoing clinical studies. irRC were designed to capture clinical activity of ipilimumab immunotherapy that may not be adequately addressed by the mWHO criteria. irComplete Response (irCR): Complete disappearance of all index and non-index lesions. irPartial Response (irPR): Decrease, relative to baseline, of 50% or greater in the sum of the products of the two largest perpendicular diameters of all index and all new measurable lesions in the absence of irCR, non-index lesions not considered. irStable Disease (irSD): Does not meet criteria for irCR or irPR, in the absence of progressive disease (irPD). irProgressive Disease (irPD): At least 25% increase in Tumor Burden when compared to sum of the products of diameters of lesions at nadir.|Day 1 to last patient, last visit, approximately 3 years|All participants randomized to a treatment arm who received at least 1 dose of ipilimumab as randomized with measurable disease at baseline, at least one baseline assessment and one on-treatment tumor assessment, no resection of index lesions, and for irRC, no resection of new lesions.||participants|||Number
794933|NCT00920907|Secondary|Best Overall Tumor Response Per Investigator Based on Modified World Health Organization (mWHO) Criteria - All Randomized Participants|Overall Response (OR) was determined as the combination of assessments of index and non-index lesions using mWHO criteria which were: Complete Response=complete disappearance of all lesions; Partial Response=decrease, relative to baseline, of 50% or greater in the sum of the products of the two largest perpendicular diameters of all index lesions, in the absence of Complete Response; Stable Disease=does not meet criteria for complete or partial response, in the absence of progressive disease, or a decrease or tumor stabilization of one or more non-index lesions; Progressive Disease (Progression)=at least 25% increase in the sum of the products of all index lesions (taking as reference the smallest sum recorded at or following baseline) and/or the appearance of any new lesion(s), or progression of non-index lesion(s). OR was measured across the entire study from Day 1 to the last patient, last visit (2009 to 2012)|Day 1 to last patient, last visit, approximately 3 years|All participants randomized to a treatment arm who received at least 1 dose of ipilimumab as randomized with measurable disease at baseline, at least one baseline assessment and one on-treatment tumor assessment, no resection of index lesions.||participants|||Number
794934|NCT00920907|Secondary|Volume of Distribution at Steady State (Vss) of Ipilimumab Manufactured by Process C Relative to the Vss of Ipilimumab Manufactured by Process B - Evaluable Pharmacokinetic Population|The single-dose Pharmacokinetic parameters of ipilimumab were derived from serum concentration versus time data. Vss was measured from first dose to end of the induction period (4 doses) in liter(s) (L). Samples were obtained at 0 hour (predose) on Days 1, 2, 3, 4, and Weeks 2, 3, 4, 7, and 10; Day 1, samples were also obtained 1 h 30 minutes (min), 2 h, 2 h 30 min, 3 h 30 min, 4 h 30 min, and 6 h post dose. In calculating PK parameters, predose concentrations and concentrations prior to first quantifiable concentration below the lower limit of quantitation (LLOQ) were treated as “missing” for the calculation of summary statistics. Drug was quantitatively determined in serum by an enzyme-linked immunosorbent assay (ELISA). Individual PK parameter values were derived by non-compartmental methods using a validated PK analysis program (Kinetica™ 4.4.1 within eToolbox [version 2.6.1]).|Day 1 to Day 84|PK evaluable Population: All participants who received at least one dose of drug and had adequate PK profiles.||L||Geometric Coefficient of Variation|Geometric Mean
794935|NCT00920907|Primary|Area Under the Serum Concentration-time Curve (AUC) From Time Zero to Day 21, AUC(0-21d), of Ipilimumab Manufactured by Process C Relative to the AUC(0-21d) of Ipilimumab Manufactured by Process B - Evaluable Pharmacokinetic Population|The single-dose pharmacokinetic parameters of ipilimumab were derived from serum concentration versus time data. AUC(0-21d) was measured from first dose to end of the induction period as micrograms*hours per milliliter (μg*h/mL). Samples were obtained at 0 hour (predose) on Days 1, 2, 3, 4, and Weeks 2, 3, 4, 7, and 10; Day 1, samples were also obtained 1 h 30 minutes (min), 2 h, 2 h 30 min, 3 h 30 min, 4 h 30 min, and 6 h post dose. In calculating PK parameters, predose concentrations and concentrations prior to first quantifiable concentration below the lower limit of quantitation (LLOQ) were treated as “missing” for the calculation of summary statistics. Drug was quantitatively determined in serum by an enzyme-linked immunosorbent assay (ELISA). Individual PK parameter values were derived by non-compartmental methods using a validated PK analysis program (Kinetica™ 4.4.1 within eToolbox [version 2.6.1]).|Day 1 to Day 84|PK evaluable Population: All participants who received at least one dose of drug and had adequate PK profiles.||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
794936|NCT00920907|Secondary|Clearance (CLT) of Ipilimumab Manufactured by Process C Relative to the CLT of Ipilimumab Manufactured by Process B - Evaluable Pharmacokinetic Population|The single-dose Pharmacokinetic parameters of ipilimumab were derived from serum concentration versus time data. CLT was measured from first dose to end of the induction period (4 doses) in milliliters per hour (mL/h). Samples were obtained at 0 hour (predose) on Days 1, 2, 3, 4, and Weeks 2, 3, 4, 7, and 10; Day 1, samples were also obtained 1 h 30 minutes (min), 2 h, 2 h 30 min, 3 h 30 min, 4 h 30 min, and 6 h post dose. In calculating PK parameters, predose concentrations and concentrations prior to first quantifiable concentration below the lower limit of quantitation (LLOQ) were treated as “missing” for the calculation of summary statistics. Drug was quantitatively determined in serum by an enzyme-linked immunosorbent assay (ELISA). Individual PK parameter values were derived by non-compartmental methods using a validated PK analysis program (Kinetica™ 4.4.1 within eToolbox [version 2.6.1]).|Day 1 to Day 84|PK evaluable Population: All participants who received at least one dose of drug and had adequate PK profiles.||mL/h||Geometric Coefficient of Variation|Geometric Mean
794982|NCT00922116|Secondary|Time Spent in Hemoglobin Range of 10.0 to 12.0 g/dL During DTP and EEP|DTP was a 16- week period from Week 1 to Week 16, EEP was an 8-week period from Weeks 17 to 24. Dose adjustment was assessed during entire Week 1 to 24.|Weeks 1 to 24|ITT population. Here number of participants analyzed = participants who were analyzed for the outcome measure.||days||Standard Deviation|Mean
794937|NCT00920907|Secondary|Terminal Elimination Half Life (T-HALF) of Ipilimumab Manufactured by Process C Relative to the T-HALF of Ipilimumab Manufactured by Process B - Evaluable Pharmacokinetic Population|The single-dose Pharmacokinetic parameters of ipilimumab were derived from serum concentration versus time data. T-HALF was measured from first dose to end of the induction period (4 doses) in day(s). Samples were obtained at 0 hour (predose) on Days 1, 2, 3, 4, and Weeks 2, 3, 4, 7, and 10; Day 1, samples were also obtained 1 h 30 minutes (min), 2 h, 2 h 30 min, 3 h 30 min, 4 h 30 min, and 6 h post dose. In calculating PK parameters, predose concentrations and concentrations prior to first quantifiable concentration below the lower limit of quantitation (LLOQ) were treated as “missing” for the calculation of summary statistics. Drug was quantitatively determined in serum by an enzyme-linked immunosorbent assay (ELISA). Individual PK parameter values were derived by non-compartmental methods using a validated PK analysis program (Kinetica™ 4.4.1 within eToolbox [version 2.6.1]).|Day 1 to Day 84|PK evaluable Population: All participants who received at least one dose of drug and had adequate PK profiles.||days||Standard Deviation|Mean
794938|NCT00920907|Secondary|Time of Maximum Observed Serum Concentration (Tmax) of Ipilimumab Manufactured by Process C Relative to the Tmax of Ipilimumab Manufactured by Process B - Evaluable Pharmacokinetic Population|The single-dose Pharmacokinetic parameters of ipilimumab were derived from serum concentration versus time data. Tmax was measured from first dose to end of the induction period (4 doses) in hours (h). Samples were obtained at 0 h (predose) on Days 1, 2, 3, 4, and Weeks 2, 3, 4, 7, and 10; Day 1, samples were also obtained 1 h 30 minutes (min), 2 h, 2 h 30 min, 3 h 30 min, 4 h 30 min, and 6 h post dose. In calculating PK parameters, predose concentrations and concentrations prior to first quantifiable concentration below the lower limit of quantitation (LLOQ) were treated as “missing” for the calculation of summary statistics. Drug was quantitatively determined in serum by an enzyme-linked immunosorbent assay (ELISA). Individual PK parameter values were derived by non-compartmental methods using a validated PK analysis program (Kinetica™ 4.4.1 within eToolbox [version 2.6.1]).|Day 1 to Day 84|PK evaluable Population: All participants who received at least one dose of drug and had adequate PK profiles.||h||Full Range|Median
794939|NCT00920907|Primary|Maximum Observed Serum Concentration (Cmax) of Ipilimumab Manufactured by Process C Relative to the Cmax of Ipilimumab Manufactured by Process B - Evaluable Pharmacokinetic Population|Single-dose Pharmacokinetic (PK) parameters of ipilimumab were derived from serum concentration versus time data. Cmax was measured from first dose to end of the induction period (4 doses) as micrograms per milliliter (μg/mL). Samples were obtained at 0 hour (predose) on Days 1, 2, 3, 4, and Weeks 2, 3, 4, 7, and 10; Day 1, samples were also obtained 1 h 30 minutes (min), 2 h, 2 h 30 min, 3 h 30 min, 4 h 30 min, and 6 h post dose. In calculating PK parameters, predose concentrations and concentrations prior to first quantifiable concentration below the lower limit of quantitation (LLOQ) were treated as “missing” for the calculation of summary statistics. Drug was quantitatively determined in serum by an enzyme-linked immunosorbent assay (ELISA). Individual PK parameter values were derived by non-compartmental methods using a validated PK analysis program (Kinetica™ 4.4.1 within eToolbox [version 2.6.1]).|Day 1 to Day 84|Pharmacokinetic (PK) evaluable Population: All participants who received at least one dose of drug and had adequate PK profiles.||μg/mL||Geometric Coefficient of Variation|Geometric Mean
794940|NCT00921024|Primary|Microbiological Response at the TOC Visit in the Microbiologically Evaluable (ME) Population.|Microbiological response is eradication for each baseline pathogen|TOC; 6-9 days after last study drug administration|ME: Treated patients, with baseline pathogen, complied with protocol.||percentage of patients||95% Confidence Interval|Number
794941|NCT00921024|Primary|Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-Treat (mMITT) Population|Microbiological response is eradication for each baseline pathogen|TOC; 6-9 days after last study drug administration|mMITT: Treated patients, with baseline pathogen.||percentage of patients||95% Confidence Interval|Number
794942|NCT00921115|Primary|Pathologic Complete Response (PCR) Rate|Pathologic complete response (PCR) rate with 4 months of neo-adjuvant combination endocrine therapy (Anastrazole and Fulvestrant).|4 months|Number of participants with PCR after 4 cycles of Neoadjuvant Endocrine Therapy||participants|||Number
794943|NCT00921310|Secondary|Phase 2 Only: Phospho-S6 Levels in Circulating Mononuclear Cells Before and After Treatment||Cycle 1 Day 1, one hour post completion of initial temsirolimus dose, and Cycle 1 Day 8|Due to early termination of the study by withdrawal of funding by sponsor (Pfizer merged with Wyeth), the peripheral blood samples that were collected for this outcome measure were not analyzed prior to losing funding.|||||
794944|NCT00921310|Secondary|Phase 2 Only: Phospho-Akt Levels in Circulating Mononuclear Cells||Cycle 1 Day 1, one hour post completion of initial temsirolimus dose, and Cycle 1 Day 8|Due to early termination of the study by withdrawal of funding by sponsor (Pfizer merged with Wyeth), the peripheral blood samples that were collected for this outcome measure were not analyzed prior to losing funding.|||||
794945|NCT00921310|Secondary|Phase 2 Only: Survival Rate||1 year after start of treatment|||percentage of participants|||Number
794946|NCT00921310|Secondary|Phase 2 Only: Progression-free Survival (PFS)|PFS is defined as the duration of time from start of treatment to time of progression.|2 years from completion of treatment|There were only (2) patients evaluable for PFS.||days|||Number
794947|NCT00921310|Primary|Phase I Only: Phospho-S6 Levels in Circulating Mononuclear Cells||Cycle 1 Day 1, one hour post completion of initial temsirolimus dose, and Cycle 1 Day 8|Due to early termination of the study by withdrawal of funding by sponsor (Pfizer merged with Wyeth), the peripheral blood samples that were collected for this outcome measure were not analyzed prior to losing funding.|||||
794948|NCT00921310|Primary|Phase I Only: Phospho-Akt Levels in Circulating Mononuclear Cells||Cycle 1 Day 1, one hour post completion of initial temsirolimus dose, and Cycle 1 Day 8|Due to early termination of the study by withdrawal of funding by sponsor (Pfizer merged with Wyeth), the peripheral blood samples that were collected for this outcome measure were not analyzed prior to losing funding.|||||
794983|NCT00922116|Secondary|Percentage of Participants Who Required Dose Adjustments During Dose Titration Period (DTP) and EEP|DTP was a 16- week period from Week 1 to Week 16, EEP was an 8-week period from Weeks 17 to 24. Dose adjustment was assessed during entire Week 1 to 24.|Weeks 1 to 24|ITT population.||percentage of participants|||Number
794984|NCT00922116|Secondary|Percentage of Participants Maintaining Hemoglobin Concentration Within Hemoglobin Range 10.0 to 12.0 g/dL Throughout the EEP|EEP was an 8 week period from Weeks 17 to 24. The 95% CI was estimated using Clopper-Pearson.|EEP (Weeks 17 to 24)|ITT population.||percentage of participants||95% Confidence Interval|Number
794949|NCT00921310|Primary|Phase I and Phase II: Overall Response Rate (Complete Response + Partial Response)|"Only those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response.
Complete response (CR)−disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level.
Partial response (PR)−at least a 30% decrease in the sum of the longest diameter (LD) of the target lesions taking as reference the baseline sum LD"|2 years|(4) patients in Phase 1 were not evaluable for response as they were removed from study prior to week 6 scans. One patient in Phase 2 was not evaluable due to expiring prior to week 6 scans.||percentage of participants|||Number
794950|NCT00921310|Primary|Phase I Only: Number of Participants Who Experience Dose-limiting Toxicities (DLT) of Temsirolimus and Pemetrexed|"DLT will be defined as occurring within the first cycle of Phase I only and will be graded according to the Common Terminology Criteria for Adverse Events v 3.0 (CTCAE)
Any grade 3 or higher hematologic toxicity with the exception of anemia.
Any grade 3 or higher non-hematologic toxicity related to study therapy (except alopecia).
Grade 3 or 4 pneumonitis or esophagitis.
Treatment delay of temsirolimus for more than 14 consecutive days due to study-related toxicity.
Treatment delay of pemetrexed therapy for more than 14 consecutive days because of study-related toxicity."|Completion of first cycle (approximately 21 days)|||participants|||Number
794951|NCT00921310|Primary|Phase I Only: Maximum Tolerated Dose (MTD) of Temsirolimus That Could be Administered Weekly in Combination With Pemetrexed|The starting dose and schedule of pemetrexed will be 500 mg/m2 given every 3 weeks and the starting dose for temsirolimus will be 15 mg given weekly for 3 weeks, to complete 1 cycle. In subsequent cohorts, dose will be escalated or de-escalated. Enrollment to each cohort is based on toxicity experienced at that dose level. The maximum tolerated dose (MTD) is defined as the dose level immediately below the dose level at which 2 patients of a cohort experience dose-limiting toxicity during the first cycle. Six patients will be enrolled at the maximum tolerated dose to ensure that no more than 2 DLTs occur at the MTD. Dose escalations will proceed until the MTD has been reached.|Completion of first cycle by all enrolled patients in Phase I portion of study|||mg|||Number
794952|NCT00921310|Primary|Phase I Only: Maximum Tolerated Dose (MTD) of Pemetrexed That Could be Administered Weekly in Combination With Temsirolimus|The starting dose and schedule of pemetrexed will be 500 mg/m2 given every 3 weeks and the starting dose for temsirolimus will be 15 mg given weekly for 3 weeks, to complete 1 cycle. In subsequent cohorts, dose will be escalated or de-escalated. Enrollment to each cohort is based on toxicity experienced at that dose level. The maximum tolerated dose (MTD) is defined as the dose level immediately below the dose level at which 2 patients of a cohort experience dose-limiting toxicity during the first cycle. Six patients will be enrolled at the maximum tolerated dose to ensure that no more than 2 DLTs occur at the MTD. Dose escalations will proceed until the MTD has been reached.|Completion of first cycle by all enrolled patients in Phase I portion of study|||mg/m^2|||Number
794953|NCT00921518|Primary|Number of Participants With Acute Kidney Injury|Acuge kidney injury is defined using the AKIN criteria|5 days|||participants|||Number
794954|NCT00921557|Secondary|Percent of Participants With Detectable Urinary Alendronate|Outcome measure required additional funding for laboratory testing which was not available, so this outcome is not reported.|Weeks 48, 96 and 144||||||
794955|NCT00921557|Secondary|Change in Centers for Disease Control (CDC) HIV Disease Category|Percentage of participants advancing in CDC HIV disease category from baseline throughout study follow-up|Weeks 144|Participants who started study treatment.||Participants|||Count of Participants
794956|NCT00921557|Secondary|Change in CD4 Percent From Baseline|Change in percentage of lymphocytes that are CD4 cells calculated as measurement at each time point minus baseline measurement|Weeks 0, 48, 96 and 144|Participants who started study treatment and had CD4 percent available at week 0.||percent of lymphocytes that are CD4 cell||95% Confidence Interval|Median
794957|NCT00921557|Secondary|Percent of Participants With HIV-1 RNA <= 400 Copies/ml|Percent calculated as number of participants with HIV-1 RNA <= 400 copies/ml relative to the number of participants with HIV-1 RNA measured at that time point.|Weeks 0, 48, 96 and 144|Participants who started study treatment.||Participants|||Count of Participants
794958|NCT00921557|Secondary|Correlation of Changes in Central Fat Content With Changes in Lumbar Spine and Whole Body (With Head) BMD|Outcome measure required additional funding for laboratory testing which was not available, so this outcome is not reported.|Weeks 0 and 48||||||
794959|NCT00921557|Secondary|Change From Baseline to Week 48 in Central Fat Content|Outcome measure required additional funding for laboratory testing which was not available, so this outcome is not reported.|Weeks 0 and 48||||||
794960|NCT00921557|Secondary|Correlation of Changes in RANKL/OPG Ratio With Changes in Lumbar Spine and Whole Body (With Head) BMD|Outcome measure required additional funding for laboratory testing which was not available, so this outcome is not reported.|Weeks 0 and 48||||||
794961|NCT00921557|Secondary|Change From Baseline to Week 48 in Receptor Activator of Nuclear Factor Kappa-B Ligand/Osteoprotegerin (RANKL/OPG) Ratio|Outcome measure required additional funding for laboratory testing which was not available, so this outcome is not reported.|Weeks 0 and 48||||||
794962|NCT00921557|Secondary|Correlation of Changes in Bone Marker Turnover With Changes in Lumbar Spine and Whole Body (With Head) BMD|Outcome measure required additional funding for laboratory testing which was not available, so this outcome is not reported.|Weeks 0 and 48||||||
794963|NCT00921557|Secondary|Change From Baseline to Week 48 in Bone Marker Turnover|Outcome measure required additional funding for laboratory testing which was not available, so this outcome is not reported.|Weeks 0 and 48||||||
794964|NCT00921557|Secondary|Percent Change From Week 48 to Week 96 (Group 1B), Week 48 to Week 144 (Group 1B), and Week 96 to 144 (Group 2) in Whole Body (With Head) BMD|Percent change was calculated as (measurement at time T2 - measurement at time T2)/measurement at time T1 * 100%.|Weeks 48, 96 and 144|All participants who started study treatment and had measurements available at both time points.||Percent change||95% Confidence Interval|Median
794965|NCT00921557|Secondary|Percent Change From Week 48 to Week 96 (Group 1B), Week 48 to Week 144 (Group 1B), and Week 96 to 144 (Group 2) in Lumbar Spine BMD|Percent change was calculated as (measurement at time T2 - measurement at time T1)/measurement at Time T1 * 100%.|Weeks 48, 96 and 144|All participants who started study treatment and had measurements available at the two time points of interest||Percent change||95% Confidence Interval|Median
794966|NCT00921557|Secondary|Effect of Other Known Bone Mineral Determinants (Age, Gender, Race/Ethnicity, Steroid Use, Depo-Provera, Tenofovir, Pubertal Stage, Bone Age, Vitamin D Status) and Inflammatory Cytokine Levels on Changes in Whole Body (With Head) BMD.|A slope was fit for each participant to their percent change [(measurement at time T - measurement at baseline)/measurement at baseline)*100%] in whole body (with head) BMD from baseline. Results represent average changes in whole body (with head) BMD over one year. Results are summarized for age, gender, ethnicity, tenofovir use, Tanner stage, bone age and vitamin D level. Only one participant was on steroids and none were using Dep-Provera. Inflammatory cytokine levels were not assayed. Results were combined for Groups 1A and 1B as both were on alendronate for the first 48 weeks.|Weeks 0, 24 and 48|Participants who started study treatment and had Whole Body (with head) available at week 0||percentage of baseline||95% Confidence Interval|Mean
794967|NCT00921557|Secondary|Effect of Other Known Bone Mineral Determinants (Age, Gender, Race/Ethnicity, Steroid Use, Depo-Provera, Tenofovir, Pubertal Stage, Bone Age, Vitamin D Status) and Inflammatory Cytokine Levels on Changes in Lumbar Spine BMD|A slope was fit for each participant to their percent change [(measurement at time T - measurement at baseline)/measurement at baseline)*100%] in lumbar spine BMD from baseline. Results represent average changes in lumbar spine BMD over one year. Results are summarized for age, gender, ethnicity, tenofovir use, Tanner stage, bone age and vitamin D level. Only one participant was on steroids and none were using Dep-Provera. Inflammatory cytokine levels were not assayed. Results were combined for Groups 1A and 1B as both were on alendronate for the first 48 weeks.|Weeks 0, 24 and 48|Participants who started study treatment||percentage of baseline||95% Confidence Interval|Mean
794968|NCT00921557|Secondary|Safety as Measured by the Incidence of New Signs, Symptoms, Hematology or Chemistry Laboratory Values Greater Than or Equal to Grade 3 or New Cases of Jaw Osteonecrosis, Atrial Fibrillation, or Non-healing Fractures|Signs, symptoms, and laboratory values were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0 (December 2004).|Weeks 0 to 144|All participants who started treatment||Participants|||Count of Participants
794969|NCT00921557|Secondary|Percent Change From Baseline to Week 96 in Whole Body (With Head) BMD|Percent change was calculated as (measurement at week 96 - measurement at baseline)/measurement at baseline * 100%. Includes Groups 1A and 1B only.|Weeks 0 and 96|Includes all participants who started study treatment and had measurements available at weeks 0 and 96||Percent change from baseline||95% Confidence Interval|Median
794970|NCT00921557|Secondary|Percent Change From Baseline to Week 96 in Lumbar Spine BMD|Percent change was calculated as (measurement at week 96 - measurement at baseline)/measurement at baseline * 100%. Includes Groups 1A and 1B only.|Weeks 0 and 96|Includes all participants who started study treatment and had measurements available at weeks 0 and 96||Percent change from baseline||95% Confidence Interval|Median
794971|NCT00921557|Secondary|Percent Change From Baseline to Weeks 24 and 48 in Whole Body (With Head) BMD|Percent change was calculated as (measurement at time T - measurement at baseline)/measurement at baseline * 100%. Results for Groups 1A and 1B were combined as both were on alendronate for the first 48 weeks.|Weeks 0, 24 and 48|Participants who started treatment and had Whole Body (with head) BMD available at week 0||Percent change from baseline||95% Confidence Interval|Median
794972|NCT00921557|Primary|Percentage of Participants Developing New Signs, Symptoms, Hematology or Chemistry Laboratory Values Greater Than or Equal to Grade 3 or New Cases of Jaw Osteonecrosis, Atrial Fibrillation, or Non-healing Fractures|Signs, symptoms, and laboratory values were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0 (December 2004). Results for Groups 1A and 1B were combined as both were on alendronate for the first 48 weeks.|Week 0 to 48|All participants who started study treatment||Participants|||Count of Participants
794973|NCT00921557|Primary|Percent Change From Baseline to Weeks 24 and 48 in Lumbar Spine BMD|Percent change was calculated as (measurement at time T - measurement at baseline)/measurement at baseline * 100%. Results for Groups 1A and 1B combined as both were on alendronate for the first 48 weeks.|Weeks 0, 24 and 48|Includes all participants who started study treatment||Percent change from baseline||95% Confidence Interval|Median
794974|NCT00921687|Secondary|Last Clinic BP <130/80 mmHg|Probability of last Clinic BP <130/80 mmHg Comparing Intervention vs Control Clinic During the Study Period as estimated using Generalized Estimating Equation.|One year|||probability of controlled clinic BP||95% Confidence Interval|Number
794975|NCT00921687|Primary|PTH (Parathyroid Hormone) Adherence|Probability for having a PTH measured during the study period comparing intervention vs control clinic during the study period as estimated by Generalized Estimating Equation (determines probability, not proportion). Participants assigned 1 if PTH was measured and 0 if PTH was not measured during the study period.|One year|||probability of having a PTH measured|||Number
794976|NCT00921895|Primary|Sensitivity and Specificity of RPS Adeno Detector IV Compared to Cell Culture.|Sensitivity is proportion of true positive cases compared to cell culture. Specificity is the proportion of true negative cases compared to cell culture.|15 minutes|||percentage of cases||95% Confidence Interval|Number
794977|NCT00921934|Primary|Change of Pain Measured by VAS|VAS (minimum = 0 = no pain, maximum = 10 = extrem pain, change of pain measured by VAS|visit 1 - 3|Three patients had no pain at baseline (score value = 0) and were thus excluded from the statistical analysis. The descriptive results per visit are presented in the data below. V1 (Baseline) N=64, V2 (week 2)N=64, V3 (week 12)N= 47, Last vsit (N=64).||pain intensity||Standard Deviation|Mean
794978|NCT00921947|Primary|Number of Participants With Local and Systemic Symptoms Post Vaccination 2 (Day 28)|Solicited local and general symptoms experienced within 14 days after vaccination 2|14 days after vaccination|||participants|||Number
794979|NCT00921947|Secondary|Anti-M2e Serum Antibody Concentration|Anti-M2e Serum Antibody Concentration summarized by study visit using the per-protocol population.|42 days (+/- 2)|||Titers||95% Confidence Interval|Geometric Mean
794980|NCT00921947|Primary|Number of Participants With Local and Systemic Symptoms Post Vaccination 1 (Day 0)|Solicited local and general symptoms experienced within 7 days after vaccination 1.|0 to 7 days after vaccination|The population analyzed included all participants receiving at least 1 dose of the vaccine.||participants|||Number
794981|NCT00922116|Secondary|Average Dose of Mircera Per Month||Weeks 0-4, 4-8, 8-12, 12-16, 16-20, and 20-24|ITT population. Here number of participants analyzed = participants who were analyzed for the outcome measure.||microgram (mcg)||Standard Deviation|Mean
794985|NCT00922116|Secondary|Change in Hemoglobin Concentration Between SVP and the EEP|Baseline hemoglobin was defined as the mean of the three assessments recorded at Weeks -4, -2, and 0 (SVP). EEP hemoglobin was defined as the mean of the hemoglobin assessments during EEP. EEP was an 8 week period from Weeks 17 to 24.|SVP (Baseline), and EEP (Weeks 17 to 24)|ITT population.||grams per deciliter (g/dL)||Standard Deviation|Mean
794986|NCT00922116|Primary|Percentage of Participants Maintaining Average Hemoglobin Concentration Within the Target Range During the Efficacy Evaluable Period (EEP)|The target hemoglobin was defined as the mean of the three assessments recorded at Weeks -4, -2, and 0 (Stability Verification Period [SVP]). EEP was an 8 week period from Weeks 17 to 24. The 95 percent (%) confidence interval (CI) was estimated using Clopper-Pearson.|EEP (Weeks 17 to 24)|Intention-to-Treat (ITT) population included all participants who received one more dose of Mircera.||percentage of participants||95% Confidence Interval|Number
794987|NCT00922194|Primary|Change in Glycosylated Haemoglobin (A1C) From Baseline at 12 Months or More|Change: Glycosylated Haemoglobin after 12 months or more of therapy - Glycosylated Haemoglobin at baseline.|Initial and at the end of 12 months or more|||Percentage of HbA1c||95% Confidence Interval|Median
794988|NCT00922194|Primary|Change in Fasting Blood Glucose From Baseline at 12 Months or More|Change: Fasting blood glucose after 12 months or more of therapy - Fasting blood glucose at baseline|Initial and at the end of 12 months or more|||mmol/L||95% Confidence Interval|Median
794989|NCT00922194|Primary|Change in Waist (Cms) /Height (Meters) Ratio From Baseline at 12 Months or More|Change: Waist/Height ratio after 12 months or more of therapy - Waist/Height ratio at baseline|Initial and at the end of 12 months or more|||Ratio||95% Confidence Interval|Median
794990|NCT00922194|Primary|Change in Waist Circumference (Cms)/Hip Circumference (Cms)From Baseline at 12 Months or More|Change: Waist circumference/Hip circumference ratio after 12 months or more of therapy - Waist circumference/Hip circumference ratio at baseline|Initial and at the end of 12 months or more|||Ratio||95% Confidence Interval|Median
794991|NCT00922194|Primary|Change in Waist Circumference From Baseline at 12 Months or More|Change: Waist circumference after 12 months or more of therapy - Waist circumference at baseline|Initial and at the end of 12 months or more|||Centimeters||95% Confidence Interval|Median
794992|NCT00922194|Primary|Change in Body Mass Index (BMI) From Baseline at 12 Months or More|Change: Body Mass Index (BMI) after 12 months of therapy or more - BMI at baseline|Initial and at the end of 12 months or more|||kg/m2||95% Confidence Interval|Median
794993|NCT00922194|Primary|Change in Weight From Baseline at 12 Months or More|Change: Weight after 12 months of therapy or more - weight at baseline|Initial and at the end of 12 months or more|||Kg||95% Confidence Interval|Median
794994|NCT00922207|Secondary|Percentage of Participants With Combined Response|Combined response was defined as having negative HBeAg, HBV DNA less than (<) 100,000 copies/mL, and normal ALT level (10-40 IU/L).|Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100|ITT analysis population. Here, n = participants who had available assessment at specified time-point.||percentage of participants|||Number
794995|NCT00922207|Secondary|Change From Baseline in HBsAg Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100||Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100|ITT analysis population. Here, n = participants who had available assessment at specified time-point.||International Units/milliliter (IU/mL)||Standard Deviation|Mean
794996|NCT00922207|Secondary|Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels|The normal range for ALT is 10 to 40 international units per liter (IU/L).|Baseline, Weeks 6, 12, 16, 22, 28, 34, 40, 46, 52, 64, 76, 88, and 100|ITT analysis population. Here, n = participants who had available assessment at specified time-point.||percentage of participants|||Number
794997|NCT00922207|Secondary|Percentage of Participant Who Were Both Hepatitis B Surface Antigen (HBsAg) Negative and Hepatitis B Surface Antibody (Anti-HBs/HBsAb) Positive||Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100|ITT analysis population. Here, n = participants who had available assessment at specified time-point.||percentage of participants|||Number
794998|NCT00922207|Secondary|Percentage of Participants Who Were HBeAg Negative||Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100|ITT analysis population. Here, n = participants who had available assessment at specified time-point.||percentage of participants||95% Confidence Interval|Number
794999|NCT00922207|Secondary|Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100|HBV DNA (copies per milliliter [copies/mL]) represented the viral load for Hepatitis B Virus (HBV), and was considered an indicator of viral replication.|Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100|ITT analysis population. Here, n = participants who had available assessment at specified time-point.||copies/mL||Standard Deviation|Mean
795000|NCT00922207|Primary|Percentage of Participants With Hepatitis B e-Antigen (HBeAg) Seroconversion at 100 Weeks After Start of Treatment|HBeAg seroconversion was defined as the absence of HBeAg (a negative result for HBeAg) and the presence of hepatitis B e-antibody (anti-HBe/HBeAb) (a positive result for anti-HBe).|Week 100|ITT analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.||percentage of participants||95% Confidence Interval|Number
795001|NCT00922233|Primary|Participant Report of Adverse Events.|Safety data includes data from each subject up to two weeks after her last use of the study tablets as well as all events deemed related to study product, regardless of date last tablet was taken|6.5 months|A total of 58 women documented use of product on coital diaries and are included in the User Population for primary safety analysis. Numbers reported in the participant Flow module, represent the total enrolled and the maximum number available for evaluation. Not all the enrolled participants could be analyzed for every outcome measure.||adverse events|||Number
795002|NCT00922233|Secondary|Acceptability Based on Bleeding Patterns Reported|Number of participants who reported bleeding patterns were acceptable and would therefore use Levonorgestrel|6.5 months|A total of 56 women reported on their bleeding patterns, of these, 43 found it acceptable. Numbers reported in the participant Flow module, represent the total enrolled and the maximum number available for evaluation. Not all the enrolled participants could be analyzed for every outcome measure.||participants|||Number
795003|NCT00922233|Primary|Efficacy: the Pearl Index (Number of Pregnancies Per 100 Woman-years) in the Primary Evaluable Population (18-35)|Participants were followed for 6.5 months.Pearl Index in the 18-35 year population was collected excluding months in which barrier methods, condoms, or emergency contraception were used unless the subject conceived|6.5 months|||pregnancies per 100 woman years|||Number
795004|NCT00922272|Secondary|Change From Open-label Baseline in CDSS at Week 4 of Double-blind Phase|CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.|Open-label Baseline and Week 4 of Double-blind Phase|Randomized SAS defined as all subjects who took at least 1 dose of randomized investigational product and for whom at least 1 follow-up safety assessment was made.||Units on a scale||Standard Deviation|Mean
795005|NCT00922272|Secondary|Change From Open-label Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at Week 10 Open-label Phase|CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.|Open-label Baseline and Week 10 Open-label Phase|Safety Analysis Set (SAS) defined as all subjects who took at least 1 dose of open-label investigational product and for whom at least 1 follow-up safety assessment was made.||Units on a scale||Standard Deviation|Mean
795006|NCT00922272|Secondary|Change From Open-label Baseline in PSQI Total Global Score at Week 4 of Double-blind Phase|PSQI evaluates 7 areas of quality and pattern of sleep. Each area is rated on a scale from 0 (better) to 3 (worse) with a total score ranging from 0 to 21. Reduction in total scores are associated with better sleep quality.|Open-label Baseline and Week 4 Double-blind Phase|Randomized SAS||Units on a scale||Standard Deviation|Mean
795007|NCT00922272|Secondary|Change From Open-label Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Global Score at Week 10 Open-label Phase|PSQI evaluates 7 areas of quality and pattern of sleep. Each area is rated on a scale from 0 (better) to 3 (worse) with a total score ranging from 0 to 21. Reduction in total scores are associated with better sleep quality.|Open-label Baseline and Week 10 Open-label Phase|SAS||Units on a scale||Standard Deviation|Mean
795008|NCT00922272|Secondary|Change From Double-blind Randomization Baseline in ACSA Total Score at Week 4 Double-blind Phase|ACSA scale has 16 symptom items rated on a scale from 0 (not at all) to 4 (extremely) with a possible total score range of 0 to 64. Higher scores indicate greater withdrawal symptom severity.|Double-blind Randomization Baseline and Week 4 Double-blind Phase|Randomized SAS||Units on a scale||Standard Deviation|Mean
795009|NCT00922272|Secondary|Change From Open-label Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at Week 10 Open-label Phase|ACSA scale has 16 symptom items rated on a scale from 0 (not at all) to 4 (extremely) with a possible total score range of 0 to 64. Higher scores indicate greater withdrawal symptom severity.|Open-label Baseline and Week 10 Open-label Phase|SAS||Units on a scale||Standard Deviation|Mean
795010|NCT00922272|Secondary|Change From Open-label Baseline in BAS Scores at Week 4 of Double-blind Phase|BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.|Open-label Baseline and Week 4 Double-blind Phase|Randomized SAS||Units on a scale||Standard Deviation|Mean
795011|NCT00922272|Secondary|Change From Open-label Baseline in Barnes Akathisia Scale (BAS) Scores at Week 10 Open-label Phase|BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.|Open-label Baseline and week 10 Open-label Phase|SAS||Units on a scale||Standard Deviation|Mean
795012|NCT00922272|Secondary|Change From Open-label Baseline in SAS Total Score at Week 4 of Double-blind Phase|SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.|Open-label Baseline and Week 4 Double-blind Phase|Randomized SAS||Units on a scale||Standard Deviation|Mean
795013|NCT00922272|Secondary|Change From Open-label Baseline in Simpson Angus Scale (SAS) Total Score at Week 10 Open-label Phase|SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.|Open-label Baseline and Week 10 Open-label Phase|SAS||Units on a scale||Standard Deviation|Mean
795014|NCT00922272|Secondary|Change From Double-blind Randomization Baseline in BRIEF-A T-Scores at Week 4 Double-blind Phase|BRIEF-A is a validated 75-item questionnaire composed of three indexes (Global Executive Composite, Behavioral Recognition Index, and Metacognition Index). Items are rated 1 (never), 2 (sometimes), and 3 (often). Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.|Double-blind Randomization Baseline and Week 4 Double-blind Phase|Randomized FAS||T-scores||Standard Error|Least Squares Mean
795015|NCT00922272|Secondary|Change From Open-label Baseline in Behavioral Rating Inventory of Executive Function - Adult Version (BRIEF-A) T-scores at Week 10 Open-label Phase|BRIEF-A is a validated 75-item questionnaire composed of three indexes (Global Executive Composite, Behavioral Recognition Index, and Metacognition Index). Items are rated 1 (never), 2 (sometimes), and 3 (often). Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.|Open-label Baseline and Week 10 Open-label Phase|FAS||T-scores||Standard Deviation|Mean
795016|NCT00922272|Secondary|Change From Double-blind Randomization Baseline in UPSA-B Scores at Week 4 Double-blind Phase|UPSA-B assesses skills in 5 areas of life functioning. It contains 2 subscales. Percentages correct on these 2 subscales are multiplied by 50. Thus, scores can range from 0 to 50 on each of these 2 subscales, and total scores can range from 0 to 100. Scores of 75 or higher are associated with independent living.|Double-blind Randomization Baseline and Week 4 Double-blind Phase|Randomized FAS||Scores on a scale||Standard Error|Least Squares Mean
795017|NCT00922272|Secondary|Change From Open-label Baseline in University of California Performance-Based Skills Assessment, Brief Version (UPSA-B) Scores at Week 10 Open-label Phase, LOCF|UPSA-B assesses skills in 5 areas of life functioning. It contains 2 subscales. Percentages correct on these 2 subscales are multiplied by 50. Thus, scores can range from 0 to 50 on each of these 2 subscales, and total scores can range from 0 to 100. Scores of 75 or higher are associated with independent living.|Open-label Baseline and week 10 Open-label Phase|FAS||Scores on a scale||Standard Deviation|Mean
795018|NCT00922272|Secondary|Change From Double-blind Randomization Baseline in HVLT-R Total Scores at Week 4 Double-blind Phase|HVLT-R measures verbal learning. Test scores are the total number of words recalled correctly over 3 trials. The test consists of 12 nouns read aloud for 3 consecutive trials and each trial is followed by a recall test.|Double-blind Randomization Baseline and week 4 Double-blind Phase|Randomized FAS||words recalled||Standard Error|Least Squares Mean
795019|NCT00922272|Secondary|Change From Open-label Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) Total Score at Week 10 Open-label Phase|HVLT-R measures verbal learning. Test scores are the total number of words recalled correctly over 3 trials. The test consists of 12 nouns read aloud for 3 consecutive trials and each trial is followed by a recall test.|Open-label Baseline and Week 10|FAS||words recalled||Standard Deviation|Mean
795020|NCT00922272|Secondary|Change From Double-blind Randomization Baseline in LNS Total Score at Week 4 Double-blind Phase|LNS is a test of verbal working memory. Subjects are presented with a sequence of numbers and letters aurally and then asked to tell the rater the numbers first from lowest to highest followed by the letters in alphabetical sequence. The measure is the number of correct sequences.|Double-blind Randomization Baseline and Week 4|Randomized FAS||correct sequences||Standard Error|Least Squares Mean
795021|NCT00922272|Secondary|Change From Open-label Baseline in Letter-Number Span Test (LNS) Total Score at Week 10 Open-label Phase|LNS is a test of verbal working memory. Subjects are presented with a sequence of numbers and letters aurally and then asked to tell the rater the numbers first from lowest to highest followed by the letters in alphabetical sequence. The measure is the number of correct sequences.|Open-label Baseline and week 10 Open-label Phase|FAS||correct sequences||Standard Deviation|Mean
795022|NCT00922272|Secondary|Change From Double-blind Randomization Baseline in BACS Total Score at Week 4 Double-blind Phase|BACS measures attention and speed of processing, and the test score is the total number correct. The measure of the test is the number of correct numerals where subjects write numerals 1-9 as matches to nonmeaningful symbols on a response sheet for 90 seconds, based upon a key provided to them.|Double-blind Randomization Baseline and Week 4|Randomized FAS||correct numerals||Standard Error|Least Squares Mean
795023|NCT00922272|Secondary|Change From Open-label Baseline in the Brief Assessment of Cognition in Schizophrenia (BACS) Total Score at Week 10 Open-label Phase|BACS measures attention and speed of processing, and the test score is the total number correct. The measure of the test is the number of correct numerals where subjects write numerals 1-9 as matches to nonmeaningful symbols on a response sheet for 90 seconds, based upon a key provided to them.|Open-label Baseline and week 10 Open-label Phase|FAS||correct numerals||Standard Deviation|Mean
795024|NCT00922272|Secondary|Percent of Participants With Improvement on CGI-C at Week 4 Double-blind Phase|CGI-C permits a global evaluation of the change of the subject's overall schizophrenia condition over time. It consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|Double-blind Phase Week 4|Randomized FAS||Percent of participants|||Number
795025|NCT00922272|Secondary|Percent of Participants With Improvement on Clinical Global Impression - Change (CGI-C) at Week 10 Open-label Phase|CGI-C permits a global evaluation of the change of the subject's overall schizophrenia condition over time. It consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|Open-label Phase Week 10|FAS||Percent of participants|||Number
795026|NCT00922272|Secondary|Percent of Participants With CGI-S at Week 4 Double-blind Phase|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|Week 4 Double-blind Phase|Randomized FAS||Percent of participants|||Number
795027|NCT00922272|Secondary|Percent of Participants With CGI-S at Double-blind Randomization Baseline|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|Double-blind Randomization Baseline|Randomized FAS||Percent of participants|||Number
795028|NCT00922272|Secondary|Percent of Participants With CGI-S at Week 10 Open-label Phase|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|Week 10 Open-label Phase|FAS||Percent of participants|||Number
795029|NCT00922272|Secondary|Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Open-label Baseline|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|Open-label Baseline|FAS||Percent of participants|||Number
795030|NCT00922272|Secondary|Change From Double-blind Randomization Baseline in PANSS Scores at Week 4 Double-blind Phase, TOCF|The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.|Double-blind Randomization Baseline and Week 4 Double-blind Phase|Randomized FAS defined as all subjects who received randomized investigational product and had a SANS-18 total scores at week 4 or at the early termination visit.||Units on a scale||Standard Error|Least Squares Mean
795031|NCT00922272|Secondary|Change From Open-label Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at Week 10 Open-label Phase, LOCF|The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.|Open-label Baseline and Week 10 Open-label Phase|FAS||Units on a scale||Standard Deviation|Mean
795032|NCT00922272|Secondary|Change From Double-blind Randomization Baseline in SANS Global Scores at Week 4 Double-blind Phase|The SANS assesses 5 symptom complexes to rate the negative symptoms of subjects. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.|Double-blind Randomization Baseline and Week 4 Double-blind Phase|RES||Units on a scale||Standard Error|Least Squares Mean
795033|NCT00922272|Secondary|Change From Open-label Baseline in SANS Global Scores at Week 10 Open-label Phase|The SANS assesses 5 symptom complexes to rate the negative symptoms of subjects. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.|Open-label Baseline and Week 10 Open-label Phase|FAS||Units on a scale||Standard Deviation|Mean
795034|NCT00922272|Secondary|Percent of Participants In Double-blind Phase Who Maintained SANS-18 Response at Week 4 Double-blind Phase|"Response is defined as reduction in total SANS score of greater than or equal to 20%.
The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment."|Week 4 Double-blind Phase|RES||Percent of participants|||Number
795035|NCT00922272|Primary|Change From Double-blind Randomization Baseline in SANS-18 Total Score at Week 4 Double-blind Phase, Termination Observation Carried Forward (TOCF)|The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.|Double-blind Randomization Baseline and Week 4 Double-blind Phase|Randomized Evaluable Set (RES) defined as all randomized subjects who were responders (Response is defined as reduction in total SANS score of greater than or equal to 20%) at the Double-blind Randomization and had SANS-18 total scores at week 4 of the Double-blind Phase or the early termination visit.||Units on a scale||Standard Error|Least Squares Mean
795036|NCT00922272|Secondary|Percent of Participants In Open-label Phase Who Were SANS-18 Responders at Week 10 Open-label Phase|"Response is defined as reduction in total SANS score of greater than or equal to 20%.
The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment."|Week 10 Open-label Phase|FAS||Percent of participants|||Number
795037|NCT00922272|Primary|Change From Open-label Baseline in Modified Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Week 10 Open-label Phase, Last Observation Carried Forward (LOCF)|The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.|Open-label Baseline and Week 10 Open-label Phase|Open-label Phase Full Analysis Set (FAS) defined as all enrolled subjects who took at least 1 dose of the investigational product and had 1 primary efficacy assessment after baseline in the Open-label Phase.||Units on a scale||Standard Deviation|Mean
795038|NCT00922428|Primary|Antalgic Position|Number of patients (in%) with an improvement of antalgic position V1 and V3 / V1 and V3 / V2 and V3 A four-point scale (0=not present, 1=slightly, 2=moderate, 3=severe) was used to record symptom severity before the beginning, during treatment and at the end of the observation period.|Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)|due to character of an observational study: descriptive, all patients who had an value||percentage of participants|||Number
795039|NCT00922428|Primary|Tenderness|Number of patients (in%) with an improvement of tenderness between V1 and V3 / V1 and V3 / V2 and V3 A four-point scale (0=not present, 1=slightly, 2=moderate, 3=severe) was used to record symptom severity before the beginning, during treatment and at the end of the observation period.|Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)|due to character of an observational study: descriptive, all patients who had an value||percentage of participants|||Number
795040|NCT00922428|Primary|Morning Stiffness|Number of patients (in%) with an improvement of morning stiffness between V1 and V3 / V1 and V3 / V2 and V3 A four-point scale (0=not present, 1=slightly, 2=moderate, 3=severe) was used to record symptom severity before the beginning, during treatment and at the end of the observation period.|Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)|due to character of an observational study: descriptive, all patients who had an value||percentage of participants|||Number
795041|NCT00922428|Primary|Pain on Weight-bearing|Number of patients (in%) with an improvement of pain on weight-bearing between V1 and V3 / V1 and V3 / V2 and V3 A four-point scale (0=not present, 1=slightly, 2=moderate, 3=severe) was used to record symptom severity before the beginning, during treatment and at the end of the observation period.|Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)|due to character of an observational study: descriptive, all patients who had an value||percentage of participants|||Number
795042|NCT00922428|Primary|Pain After Rest|Number of patients (in %) with an improvement of pain after rest between V1 and V3 / V1 and V3 / V2 and V3 A four-point scale (0=not present, 1=slightly, 2=moderate, 3=severe) was used to record symptom severity before the beginning, during treatment and at the end of the observation period.|Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)|due to character of an observational study: descriptive, all patients who had an value||percentage of participants|||Number
795043|NCT00922428|Primary|Pain in Movement|Number of patients (in %) with an improvement of pain in movement between V1 and V3 / V1 and V3 / V2 and V3 A four-point scale (0=not present, 1=slightly, 2=moderate, 3=severe) was used to record symptom severity before the beginning, during treatment and at the end of the observation period.|Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)|due to character of an observational study: descriptive, all patients who had an value||percentage of participants|||Number
795044|NCT00922428|Primary|Pain at Rest|Number of patient (in %) with an improvement of pain at rest between V1 and V2 / V1 and V3 / V2 and V3 A four-point scale (0=not present, 1=slightly, 2=moderate, 3=severe) was used to record symptom severity before the beginning, during treatment and at the end of the observation period.|Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)|due to character of an observational study: descriptive, all patients who had an value||percentage of participants|||Number
795045|NCT00922428|Secondary|Acceptance of the Drug|Number of patients with good (patient was satisfied with the treatment, there was nothing to complain about) or poor (patient was not satisfied with the treatment, there were ADRs or other reasons) acceptance.|from enrollment until completion|due to the character of an observational study: descriptive||percentage of participants|||Number
795046|NCT00922428|Primary|Tolerability of the Drug|"Tolerability assessment of medical personnel End of study could by after 2 (visit 2) or after 4 weeks (Visit3).
It was measured by a score:
very well tolerated (no side effects)
moderately tolerated (mild side effects)
poorly tolerated (marked side effects)"|after end of study|1374 were full analysed, data of 2 patient were additionally analysed for tolerability||percentage of participants|||Number
795047|NCT00922428|Primary|Visual Analog Scale (VAS)|Efficacy of the drug, measured by a Visual Analog Scale (VAS) Scale ranged from 0(=best, no pain) to 10(worst, intolerable pain) The VAS was filled by the patient.|Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)|due to character of an observational study: all patient who had a value, descriptive||units on a scale||Standard Deviation|Mean
795048|NCT00922623|Primary|Percentage of Subjects With Product-related Adverse Events.|Adverse events considered possibly, probably, or definitely related to study product are summarized by body system and MedDRA preferred term.|24 weeks|The Full Analysis Set (FAS) consisted of all subjects enrolled and treated with Belotero (ITT principle).||percentage of subjects with AEs.|||Number
795049|NCT00922636|Secondary|Number of Participants With a Response (Response Rate) up to Week 8 in Stimulant Naive Methylphenidate Group|Response rate analysis compared the frequency of response between LY2216684 treatment groups versus placebo for participants who had a final study period II (weeks 1-8) Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered and Scored (ADHD-RS-IV-PV:IR) total score <=60% of their baseline total score. ADHD-RS-IV-PV:IR measures 18 symptoms in Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) ADHD diagnosis. Item scores range: 0 (none/never or rarely) to 3 (severe/very often). Total scores range: 0 to 54.|Baseline, up to 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.||Participants|||Number
795050|NCT00922636|Secondary|Number of Participants With a Response (Response Rate) up to Week 8|Response rate analysis compared the frequency of response between LY2216684 treatment groups versus placebo for participants who had a final study period II (weeks 1-8) Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered and Scored (ADHD-RS-IV-PV:IR) total score <=60% of their baseline total score. ADHD-RS-IV-PV:IR measures 18 symptoms in Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) ADHD diagnosis. Item scores range: 0 (none/never or rarely) to 3 (severe/very often). Total scores range: 0 to 54.|Baseline, up to 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.||Participants|||Number
795051|NCT00922636|Secondary|Change From Baseline in the Wechsler Intelligence Scale for Children - Fourth Edition (WISC-IV) Digit Span Subtotal Scores at Week 8 in Stimulant Naive Methylphenidate Group|Measures attention, concentration, sequencing, number facility, and auditory short-term memory. Digit forward and digit backward subscales each comprise 2 trials and 8 items. Scaled scores range from 1 to 19. Higher scores denote better performance. Least Squares Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.||units on a scale||Standard Error|Least Squares Mean
795052|NCT00922636|Secondary|Change From Baseline in the Wechsler Intelligence Scale for Children - Fourth Edition (WISC-IV) Digit Span Subtotal Scores at Week 8|Measures attention, concentration, sequencing, number facility, and auditory short-term memory. Digit forward and digit backward subscales each comprise 2 trials and 8 items. Scaled scores range from 1 to 19. Higher scores denote better performance. Least Squares Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.||units on a scale||Standard Error|Least Squares Mean
795053|NCT00922636|Secondary|Change From Baseline in the Wechsler Intelligence Scale for Children - Fourth Edition (WISC-IV) Digit Span Total Score at Week 8 in Stimulant Naive Methylphenidate Group|A working memory subtest of WISC-IV, a measure of attention; concentration; sequencing; number facility; and auditory short-term memory. Scaled scores range from 1 to 19. Higher scores denote better performance. Least Squares (LS) Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis and included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, as well as the continuous, fixed effects of baseline Digit Span total score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.||units on a scale||Standard Error|Least Squares Mean
795054|NCT00922636|Secondary|Change From Baseline in the Wechsler Intelligence Scale for Children - Fourth Edition (WISC-IV) Digit Span Total Score at Week 8|A working memory subtest of WISC-IV, a measure of attention; concentration; sequencing; number facility; and auditory short-term memory. Scaled scores range from 1 to 19. Higher scores denote better performance. Least Squares (LS) Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis and included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, as well as the continuous, fixed effects of baseline Digit Span total score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.||units on a scale||Standard Error|Least Squares Mean
795105|NCT00922766|Other Pre-specified|Number of Participants With Cardiac Arrest- Resuscitated|Cardiac arrest resuscitated was defined as sudden cessation of cardiac activity so that the participant became unresponsive, with no normal breathing and no signs of circulation. Cardiac arrest was used to signify an event that was reversed, usually by cardio-pulmonary resuscitation (CPR) and/or defibrillation or cardioversion, or cardiac pacing.|Baseline to 28 days after last dose of study drug|FAS included all enrolled participants who received at least 1 dose of the study medication.||Participants|||Number
795055|NCT00922636|Secondary|Change From Baseline in the ADHDRS-IV-Parent:Inv Hyperactivity-Impulsivity and Inattention Subtotal Scores at Week 8 in Stimulant Naive Methylphenidate Group|Measures ADHD diagnostic symptoms (0=none/never-3=severe/very often). Inattention=sum odd items; hyperactivity-impulsivity=sum even items (subtotal: 0-27). Total scores: 0-54. High score=greater illness severity. Missing data-imputation in manual was applied. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis; included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.||units on a scale||Standard Error|Least Squares Mean
795056|NCT00922636|Secondary|Change From Baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Hyperactivity-Impulsivity and Inattention Subtotal Scores at Week 8|Measures ADHD diagnostic symptoms (0=none/never-3=severe/very often). Inattention=sum odd items; hyperactivity-impulsivity=sum even items (subtotal: 0-27). Total scores: 0-54. High score=greater illness severity. Missing data-imputation in manual was applied. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis; included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.||units on a scale||Standard Error|Least Squares Mean
795057|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Mixed Episode Score at Week 8 in Stimulant Naive Methylphenidate Group|The mixed episode score does not exist in the Conners CBRS scale; therefore no analyses could be conducted.|Baseline, 8 weeks|No participants had data analyzed because the mixed episode score does not exist in the outcome measure; therefore, no analyses could be conducted.|||||
795058|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Mixed Episode Score at Week 8|The mixed episode score does not exist in the Conners CBRS scale; therefore no analyses could be conducted.|Baseline, 8 weeks|No participants had data analyzed because the mixed episode score does not exist in the outcome measure; therefore, no analyses could be conducted.|||||
795059|NCT00922636|Secondary|Change From Baseline in the Weekly Parent Ratings of Evening and Morning Behavior-Revised (WPREMB-R ) Evening Summary Score at Week 8 in Stimulant Naive Methylphenidate Group|Measures difficulty level of 8 common evening behaviors (for example, sit through dinner) from 0 (no difficulty) to 3 (a lot of difficulty). Total score ranges: 0 to 24; higher scores indicate greater difficulty in evening behavior. Least Squares (LS) Mean Change is from restricted maximum likelihood-based, mixed model repeated measure analysis (MMRM) and included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline evening score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.||units on a scale||Standard Error|Least Squares Mean
795060|NCT00922636|Secondary|Change From Baseline in the Weekly Parent Ratings of Evening and Morning Behavior-Revised (WPREMB-R ) Evening Summary Score at Week 8|Measures difficulty level of 8 common evening behaviors (for example, sit through dinner) from 0 (no difficulty) to 3 (a lot of difficulty). Total score ranges: 0 to 24; higher scores indicate greater difficulty in evening behavior. Least Squares (LS) Mean Change is from restricted maximum likelihood-based, mixed model repeated measure analysis (MMRM) and included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline evening score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.||units on a scale||Standard Error|Least Squares Mean
795061|NCT00922636|Secondary|Change From Baseline in the Weekly Parent Ratings of Evening and Morning Behavior-Revised (WPREMB-R) Morning Summary Score at Week 8 in Stimulant Naive Methylphenidate Group|Measures difficulty level of 3 common morning behaviors (for example, get out of bed) from 0 (no difficulty) to 3 (a lot of difficulty). Total score range is from 0 to 9; a higher score indicates greater difficulty in morning behavior. Least Squares (LS) Mean Change from restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis and includes fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline morning score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.||units on a scale||Standard Error|Least Squares Mean
795062|NCT00922636|Secondary|Change From Baseline in the Weekly Parent Ratings of Evening and Morning Behavior-Revised (WPREMB-R) Morning Summary Score at Week 8|Measures difficulty level of 3 common morning behaviors (for example, get out of bed) from 0 (no difficulty) to 3 (a lot of difficulty). Total score range is from 0 to 9; a higher score indicates greater difficulty in morning behavior. Least Squares (LS) Mean Change from restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis and includes fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline morning score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.||units on a scale||Standard Error|Least Squares Mean
795106|NCT00922766|Other Pre-specified|Number of Participants With Stroke|Stroke was defined as a sudden, focal neurologic deficit that was not reversible within 24 hours and was not the result of any readily identifiable cause (for example, tumor or trauma).|Baseline to 28 days after last dose of study drug|FAS included all enrolled participants who received at least 1 dose of the study medication.||Participants|||Number
795063|NCT00922636|Secondary|Change From Baseline in the Weekly Parent Ratings of Evening and Morning Behavior-Revised (WPREMB-R) Total Score at Week 8 in Stimulant Naive Methylphenidate Group|Parent-completed 11-item questionnaire (3 morning items, 8 evening items) on a scale of 0 (no difficulty) to 3 (a lot of difficulty). Total score ranges from 0 to 33; higher score=greater difficulty in evening and morning behavior. Least Squares (LS) Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis and includes fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.||units on a scale||Standard Error|Least Squares Mean
795064|NCT00922636|Secondary|Change From Baseline in the Weekly Parent Ratings of Evening and Morning Behavior-Revised (WPREMB-R) Total Score at Week 8|Parent-completed 11-item questionnaire (3 morning items, 8 evening items) on a scale of 0 (no difficulty) to 3 (a lot of difficulty). Total score ranges from 0 to 33; higher score=greater difficulty in evening and morning behavior. Least Squares (LS) Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis and includes fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.||units on a scale||Standard Error|Least Squares Mean
795065|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Major Depressive Episode Score at Week 8 in Stimulant Naive Methylphenidate Group|Assess depressive symptom severity. Individual subscale items range: 0 (never, seldom) to 3 (very often/frequently). Total expressed as T-score based on gender/age norms (0-100). Higher T-scores=greater depression. Change scores=Week 8 score-baseline score. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis and included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.||T-Score||Standard Error|Least Squares Mean
795066|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Major Depressive Episode Score at Week 8|Assess depressive symptom severity. Individual subscale items range: 0 (never, seldom) to 3 (very often/frequently). Total expressed as T-score based on gender/age norms (0-100). Higher T-scores=greater depression. Change scores=Week 8 score-baseline score. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis and included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.||T-Score||Standard Error|Least Squares Mean
795067|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Conduct Disorder Symptom Subscale Score at Week 8 in Stimulant Naive Methylphenidate Group|Assess conduct disorder symptom severity. Individual subscale items: 0 (never/seldom) - 3 (very often/frequently). Total expressed as T-score based on gender/age norms (0-100). Higher T-score=greater conduct disorder. Change scores=Week 8 score-baseline score. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis; included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.||T-Score||Standard Error|Least Squares Mean
795068|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Conduct Disorder Symptom Subscale Score at Week 8|Assess conduct disorder symptom severity. Individual subscale items: 0 (never/seldom) - 3 (very often/frequently). Total expressed as T-score based on gender/age norms (0-100). Higher T-score=greater conduct disorder. Change scores=Week 8 score-baseline score. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis; included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.||T-Score||Standard Error|Least Squares Mean
795069|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Generalized Anxiety Disorder (GAD) and Separation Anxiety Disorder Symptom Subscales at Week 8 in Stimulant Naive Methylphenidate Group|Assess anxiety symptom severity. Individual subscale items: 0 (never, seldom) - 3 (very often/frequently). Total score expressed as T-score based on gender/age norms (0-100). Higher T-scores=greater anxiety. Change scores=Week 8 score-baseline score. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.||T-Score||Standard Error|Least Squares Mean
795107|NCT00922766|Primary|Number of Participants With Minor Bleeding Events|Bleeding events like hematuria, wound hematoma or injection site hematoma which did not fulfill the criteria for a major bleeding episode were classified as minor bleeding.|Baseline to 28 days after last dose of study drug|FAS included all enrolled participants who received at least 1 dose of the study medication.||Participants|||Number
795070|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Generalized Anxiety Disorder (GAD) and Separation Anxiety Disorder Symptom Subscales at Week 8|Assess anxiety symptom severity. Individual subscale items: 0 (never, seldom) - 3 (very often/frequently). Total score expressed as T-score based on gender/age norms (0-100). Higher T-scores=greater anxiety. Change scores=Week 8 score-baseline score. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.||T-Score||Standard Error|Least Squares Mean
795071|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Symptom Subscale for Oppositional Defiant Disorder (ODD) Total Score at Week 8 in Stimulant Naive Methylphenidate Group|Assess ODD symptom severity. Individual subscale items range from 0 (never) to 3 (very often/frequently). Total is expressed as a T-score based on gender/age norms (range 0-100). Higher T-score=greater ODD. Change scores=Week 8 score-baseline score. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.||T-Score||Standard Error|Least Squares Mean
795072|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Symptom Subscale for Oppositional Defiant Disorder (ODD) Total Score at Week 8|Assess ODD symptom severity. Individual subscale items range from 0 (never) to 3 (very often/frequently). Total is expressed as a T-score based on gender/age norms (range 0-100). Higher T-score=greater ODD. Change scores=Week 8 score-baseline score. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline at least 1 post-baseline result, excluding data from participants whose data may have been compromised.||T-Score||Standard Error|Least Squares Mean
795073|NCT00922636|Secondary|Change From Baseline in the Rapid Automatized Naming/Rapid Alternating Stimulus Test (RAN/RAS) Subtotal Scores at Week 8 in Stimulant Naive Methylphenidate Group|Assesses ability to accurately and rapidly recognize and name visual symbols. The tests consist of rapid automatized naming tests (that is, Letters, Numbers, Objects, Colors) and 2 rapid alternating stimulus tests (that is, 2-Set Letters and Numbers; 3-Set Letters, Numbers, and Colors). Scores are based on the amount of time required to name all the stimulus items in each test section. Raw scores were converted to standard scores based on participant's age and conversion tables from manual (mean=100, standard deviation=15). Higher scores=better ability. Least Squares (LS) Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.||units on a scale||Standard Error|Least Squares Mean
795074|NCT00922636|Secondary|Change From Baseline in the Rapid Automatized Naming/Rapid Alternating Stimulus Test (RAN/RAS) Subtotal Scores at Week 8|Assesses ability to accurately and rapidly recognize and name visual symbols. The tests consist of rapid automatized naming tests (that is, Letters, Numbers, Objects, Colors) and 2 rapid alternating stimulus tests (that is, 2-Set Letters and Numbers; 3-Set Letters, Numbers, and Colors). Scores are based on the amount of time required to name all the stimulus items in each test section. Raw scores were converted to standard scores based on participant's age and conversion tables from manual (mean=100, standard deviation=15). Higher scores=better ability. Least Squares (LS) Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.||units on a scale||Standard Error|Least Squares Mean
795075|NCT00922636|Primary|Change From Baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered and Scored (ADHD-RS-IV-PV:IR) Total Score at Week 8 in Stimulant Naive Methylphenidate Group|Assesses 18 Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision ADHD diagnosis symptoms/severity in past week. Each item: 0 (none/never, rarely) to 3 (severe/very often). Total score ranges from 0 to 54. Higher total scores indicate greater illness severity. Change scores=Week 8 score-baseline score. LS Mean Change adjusted for fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.||units on a scale||Standard Error|Least Squares Mean
795108|NCT00922766|Primary|Number of Participants With Major Bleeding Events|Bleeding events were considered major if, accompanied by a decrease in hemoglobin of more than or equal to 2 grams/deciliter (g/dL) in connection with clinical symptoms; a transfusion was required; bleeding led to interruption of treatment or death; or intracranial bleeding.|Baseline to 28 days after last dose of study drug|FAS included all enrolled participants who received at least 1 dose of the study medication.||Participants|||Number
795109|NCT00922766|Primary|Number of Participants With Death or Myocardial Infarction (MI)||Baseline to 28 days after last dose of study drug|The full analysis set (FAS) included all enrolled participants who received at least 1 dose of the study medication.||Participants|||Number
795076|NCT00922636|Secondary|Change From Baseline in the Wechsler Intelligence Scale for Children - Fourth Edition (WISC-IV) Letter-Number Sequencing Score at Week 8 in Stimulant Naive Methylphenidate Group|Working memory subtest. Task involves sequencing, mental manipulation, attention, short-term memory, visual spatial imaging, and processing speed; consists of 10 items, 3 trials each. Scaled scores range: 1 to 19. Higher scores denote better performance. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis that included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.||units on a scale||Standard Error|Least Squares Mean
795077|NCT00922636|Secondary|Change From Baseline in the Wechsler Intelligence Scale for Children - Fourth Edition (WISC-IV) Letter-Number Sequencing Score at Week 8|Working memory subtest. Task involves sequencing, mental manipulation, attention, short-term memory, visual spatial imaging, and processing speed; consists of 10 items, 3 trials each. Scaled scores range: 1 to 19. Higher scores denote better performance. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis that included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.||units on a scale||Standard Error|Least Squares Mean
795078|NCT00922636|Secondary|Change From Baseline in the Child Health and Illness Profile - Child Edition (CHIP-CE) at Week 8 in Stimulant Naive Methylphenidate Group|76-item parent-rated assessment of child’s health status/functioning level. Most items assess frequency of activities/feelings (1=never, 5=always). Standard scores (T-scores) were calculated for all domains by adjusting raw scores based on an established reference group mean and standard deviation (T-scores mean=50, standard deviation=10). Higher scores denote improvement. Least Squares (LS) Mean Change is from an analysis of ANCOVA model that included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), and baseline domain score.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.||T-Score||Standard Error|Least Squares Mean
795079|NCT00922636|Secondary|Change From Baseline in the Child Health and Illness Profile - Child Edition (CHIP-CE) at Week 8|76-item parent-rated assessment of child’s health status/functioning level. Most items assess frequency of activities/feelings (1=never, 5=always). Standard scores (T-scores) were calculated for all domains by adjusting raw scores based on an established reference group mean and standard deviation (T-scores mean=50, standard deviation=10). Higher scores denote improvement. Least Squares (LS) Mean Change is from an analysis of covariance model that included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), and baseline domain score.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.||T-Score||Standard Error|Least Squares Mean
795080|NCT00922636|Secondary|Change From Baseline in the Child Health and Illness Profile-Adolescent Edition (CHIP-AE) Domain Scores at Week 8 in Stimulant Naive Methylphenidate Group|Assesses adolescent’s health status/functioning level. Domains: Achievement, Satisfaction, Comfort, Risk Avoidance, Resilience. Items assess frequency of activities/feelings (1=never, 5=always). Standard scores (T-scores) calculated for all domains by adjusting raw scores based on established reference group mean, standard deviation (T-scores mean=50, standard deviation=10). Higher scores=better health. Least squares (LS) mean of the change from baseline to endpoint (week 8) is from an ANCOVA model. The model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), and baseline CHIP-AE domain score.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.||T-Score||Standard Error|Least Squares Mean
795081|NCT00922636|Secondary|Change From Baseline in the Child Health and Illness Profile-Adolescent Edition (CHIP-AE) Domain Scores at Week 8|Assesses adolescent’s health status/functioning level. Domains: Achievement, Satisfaction, Comfort, Risk Avoidance, Resilience. Items assess frequency of activities/feelings (1=never, 5=always). Standard scores (T-scores) calculated for all domains by adjusting raw scores based on established reference group mean, standard deviation (T-scores mean=50, standard deviation=10). Higher scores=better health. Least Squares (LS) Mean Change from analysis of covariance model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), and baseline score.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.||T-Score||Standard Error|Least Squares Mean
795082|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS) Content Subscales - Total Score at Week 8 in Stimulant Naive Methylphenidate Group|Assess aggressive behaviors, academic difficulties, social problems, violence potential. Individual subscale items range: 0=never to 3=very often. Total expressed as T-score based on gender/age norms (0-100). Change scores=Week 8 score-baseline score. Least Squares (LS) Mean Change from restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis; included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score, baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.||T-Score||Standard Error|Least Squares Mean
795110|NCT00922779|Secondary|Percentage of Participants With Change in Hemoglobin Level|Change in hemoglobin level (compared to baseline) was reported as “significant decrease”, “Normal” (no change), “Increase”, “Decrease”, and “Missing”. Significant decrease was defined as per Investigator's discretion.|Baseline, Weeks 2, 4, 8, 12, 24, 36, 48 and follow-up Weeks 4 (Week 52), 12 (Week 60), and 24 (Week 72)|ITT Population.||Percentage of Participants|||Number
795083|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS) Content Subscales - Total Score at Week 8|Assess aggressive behaviors, academic difficulties, social problems, violence potential. Individual subscale items range: 0=never to 3=very often. Total expressed as T-score based on gender/age norms (0-100). Change scores=Week 8 score-baseline score. Least Squares (LS) Mean Change from restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis; included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score, baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.||T-Score||Standard Error|Least Squares Mean
795084|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Symptom Subscale for Manic Episode - Total Score at 8 Weeks in Stimulant Naive Methylphenidate Group|Measures manic symptom severity. Individual subscale items range: 0 (never) to 3 (very often). Total score expressed as T-score based on gender/age norms (0-100). Higher T-scores=greater symptom severity. Change scores=Week 8 score-baseline score. Least Squares Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.||T-Score||Standard Error|Least Squares Mean
795085|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Symptom Subscale for Manic Episode - Total Score at Week 8|Measures manic symptom severity. Individual subscale items range: 0 (never) to 3 (very often). Total score expressed as T-score based on gender/age norms (0-100). Higher T-scores=greater symptom severity. Change scores=Week 8 score-baseline score. Least Squares Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.||T-Score||Standard Error|Least Squares Mean
795086|NCT00922636|Secondary|Number of Participants With Suicidal Behaviors, Ideations, and Acts Based on The Columbia Suicide Severity Rating Scale (C-SSRS) at Week 8 in Stimulant Naive Methylphenidate Group|"Captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors, ideations, and acts are provided. Suicidal behavior: a yes answer to any of 3 suicidal behavior questions: preparatory acts or behavior, aborted attempt, and interrupted attempt. Suicidal ideation: yes answer to any one of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation. Suicidal act: a yes answer to actual attempt or completed suicide, nonfatal suicide attempt, and completed suicide."|8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.||Participants|||Number
795087|NCT00922636|Secondary|Number of Participants With Suicidal Behaviors, Ideations, and Acts Based on The Columbia Suicide Severity Rating Scale (C-SSRS) at Week 8|"Captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors, ideations, and acts are provided. Suicidal behavior: a yes answer to any of 3 suicidal behavior questions: preparatory acts or behavior, aborted attempt, and interrupted attempt. Suicidal ideation: yes answer to any one of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation. Suicidal act: a yes answer to actual attempt or completed suicide, nonfatal suicide attempt, and completed suicide."|8 weeks|Intent to treat (ITT). All randomized participants with a baseline and at least 1 post-baseline C-SSRS assessment.||Participants|||Number
795088|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS) Impairment Items Subscales-Total Score at Week 8 in Stimulant Naive Methylphenidate Group|Rates schoolwork/grades, friendships/relationships, home life functioning (0=never to 3=very often). Total score expressed as a T-score based on gender/age norms (range 0-100). Higher T-score=greater symptom severity. Change scores=Week 8 score-baseline score. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis; included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.||T-Score||Standard Error|Least Squares Mean
795089|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS) Impairment Items Subscales-Total Score at Week 8|Rates schoolwork/grades, friendships/relationships, home life functioning (0=never to 3=very often). Total score expressed as a T-score based on gender/age norms (range 0-100). Higher T-score=greater symptom severity. Change scores=Week 8 score-baseline score. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis; included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.||T-Score||Standard Error|Least Squares Mean
795111|NCT00922779|Secondary|Percentage of Participants With Undetectable HCV RNA at Weeks 12, 24 and 48 After Therapy Initiation|HCV RNA levels of < 50 International Units per milliliter (IU/mL) were defined as undetectable HCV RNA. The percentage of participants with undetectable HCV RNA was calculated as [number of participants with undetectable HCV RNA divided by the total number of participants analyzed] multiplied by 100 for Weeks 12, 24 and 48.|Weeks 12,24 and 48 After Therapy Initiation|ITT Population.||Percentage of Participants|||Number
795090|NCT00922636|Secondary|Change From Baseline in the Swanson, Nolan and Pelham (SNAP-IV) Oppositional Defiant Disorder (ODD) Total Score at Week 8 in Stimulant Naive Methylphenidate Group|Measures oppositional defiance disorder symptoms. Total scores range from 0 (not at all) to 3 (very much). Higher total scores represent greater ODD. Change scores=Week 8 score-baseline score. Least Squares Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline total score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.||units on a scale||Standard Error|Least Squares Mean
795091|NCT00922636|Secondary|Change From Baseline in the Swanson, Nolan and Pelham (SNAP-IV) Oppositional Defiant Disorder (ODD) Total Score at Week 8|Measures oppositional defiance disorder symptoms. Total scores range from 0 (not at all) to 3 (very much). Higher total scores represent greater ODD. Change scores=Week 8 score-baseline score. Least Squares Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline total score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.||units on a scale||Standard Error|Least Squares Mean
795092|NCT00922636|Secondary|Change From Baseline in the CP-CBRS DSM-IV-TR ADHD Predominantly Hyperactive-Impulsive Type and Predominantly Inattentive Type Total Score and Symptom Scores at Week 8 in Stimulant Naive Methylphenidate Group|Measures ADHD symptom severity. Individual items on each subscale are scored from 0 (never) to 3 (very often). Total score expressed as T-score based on gender/age norms. Subscale total T-scores (0-100); higher T-scores=greater symptom severity. Least Squares Mean Change is from restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline total score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.||T-Score||Standard Error|Least Squares Mean
795093|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR ADHD) Predominantly Hyperactive-Impulsive Type and Predominantly Inattentive Type Total Score and Symptom Scores at Week 8|Measures ADHD symptom severity. Individual items on each subscale are scored from 0 (never) to 3 (very often). Total score expressed as T-score based on gender/age norms. Subscale total T-scores (0-100); higher T-scores=greater symptom severity. Least Squares Mean Change is from restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline total score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.||T-Score||Standard Error|Least Squares Mean
795094|NCT00922636|Secondary|Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Improvement Scale (CGI-ADHD-I) Endpoint Score During the Treatment Phase (Weeks 1-8) in Stimulant Naive Methylphenidate Group|Measures total improvement (or worsening) of a participant's ADHD symptoms from the beginning of treatment. Scores range from 1 (very much improved) to 7 (very much worsened). Lower scores represent greater improvement. Least Squares (LS) Mean Change for weeks 1-8 is from a restricted maximum likelihood-based, mixed model repeated measure analysis. The model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction.|Weeks 1 through 8|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.||Total Score||Standard Error|Least Squares Mean
795095|NCT00922636|Secondary|Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Improvement Scale (CGI-ADHD-I) Endpoint Score During the Treatment Phase (Weeks 1-8)|Measures total improvement (or worsening) of a participant's ADHD symptoms from the beginning of treatment. Scores range from 1 (very much improved) to 7 (very much worsened). Lower scores represent greater improvement. Least Squares (LS) Mean Change for weeks 1-8 is from a restricted maximum likelihood-based, mixed model repeated measure analysis. The model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction.|Weeks 1 through 8|Per protocol (PP) population included all randomized participants with a post-baseline result, excluding data from participants whose data may have been compromised.||units on a scale||Standard Error|Least Squares Mean
795096|NCT00922636|Secondary|Change From Baseline in the Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale (CGI-ADHD-S) Total Score at Week 8 in Stimulant Naive Methylphenidate Group|Measures participant's overall ADHD symptom severity. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Higher scores represent greater illness severity. Change scores=Week 8 score-baseline score. The Least Squares (LS) Mean Change was based on the fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, as well as the continuous, fixed effects of baseline CGI-S score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.||units on a scale||Standard Error|Least Squares Mean
795148|NCT00913458|Secondary|Physician's Global Assessment of Disease Activity|Physician Global Assessment of Disease Activity was measured on a 0 to 100 Visual Analog Scale (VAS), with 0 = no disease activity and 100 = extreme disease activity.|52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.||Units on a scale||Standard Deviation|Mean
795097|NCT00922636|Secondary|Change From Baseline in the Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale (CGI-ADHD-S) Total Score at Week 8|Measures participant's overall ADHD symptom severity. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Higher scores represent greater illness severity. Change scores=Week 8 score-baseline score. The Least Squares (LS) Mean Change was based on the fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, as well as the continuous, fixed effects of baseline CGI-S score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.||units on a scale||Standard Error|Least Squares Mean
795098|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS) Academic Difficulties Total Score and the Language and Math Subscales at Week 8 in Stimulant Naive Methylphenidate Group|The CP-CBRS academic difficulties total/language/math subscale score is a measure of academic performance. Each subscale item score ranges from 0 (never, seldom) to 3 (very often, very frequently). Total score is expressed as T-score based on gender/age norms. Academic difficulties T-score range: 0-100. Higher T-scores denote greater academic difficulties. Change scores=Week 8 score-baseline score. Least Squares Mean Change is adjusted for fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline total score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.||T-Score||Standard Error|Least Squares Mean
795099|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS) Academic Difficulties Total Score and the Language and Math Subscales at Week 8|The CP-CBRS academic difficulties total/language/math subscale score is a measure of academic performance. Each subscale item score ranges from 0 (never, seldom) to 3 (very often, very frequently). Total score is expressed as T-score based on gender/age norms. Academic difficulties T-score range: 0-100. Higher T-scores denote greater academic difficulties. Change scores=Week 8 score-baseline score. Least Squares Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis adjusted for fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline total score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.||T-Score||Standard Error|Least Squares Mean
795100|NCT00922636|Secondary|Change From Baseline in the Swanson, Nolan and Pelham Questionnaire: Attention-Deficit/Hyperactivity Disorder Subscale (SNAP-IV: ADHD) Total Score at Week 8 in Stimulant Naive Methylphenidate Group|Includes Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision ADHD criteria for inattention (items 1-9) and hyperactivity/impulsivity (items 11-19) symptom subsets. Item score: 0 (not at all) to 3 (very much) rating scale. Total score is average of 18 items. Higher total scores=greater ADHD symptoms. Least Squares Mean change is adjusted for fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and the continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.||units on a scale||Standard Error|Least Squares Mean
795101|NCT00922636|Secondary|Change From Baseline in the Swanson, Nolan and Pelham Questionnaire: Attention-Deficit/Hyperactivity Disorder Subscale (SNAP-IV: ADHD) Total Score at Week 8|Includes Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision ADHD criteria for inattention (items 1-9) and hyperactivity/impulsivity (items 11-19) symptom subsets. Item score: 0 (not at all) to 3 (very much) rating scale. Total score is average of 18 items. Higher total scores=greater ADHD symptoms. Least Squares Mean change is adjusted for fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and the continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) participant population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.||units on a scale||Standard Error|Least Squares Mean
795102|NCT00922636|Primary|Change From Baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered and Scored (ADHD-RS-IV-PV:IR) Total Score at Week 8|Assesses 18 Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision ADHD diagnosis symptoms/severity in past week. Each item: 0 (none/never, rarely) to 3 (severe/very often). Total score ranges from 0 to 54. Higher total scores indicate greater illness severity. Change scores=Week 8 score-baseline score. Least Squares (LS) Mean Change adjusted for fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data might have been compromised.||units on a scale||Standard Error|Least Squares Mean
795103|NCT00922701|Primary|Long Dwell Ultrafiltration|The amount of fluid recovered from the peritoneum at the end of the nocturnal exchange (long dwell) with a peritoneal dialysis solution.|day 5|||milliliters||Standard Deviation|Mean
795104|NCT00922766|Other Pre-specified|Number of Participants With Heparin Induced Thrombocytopenia|Thrombocytopenia was defined as a disorder in which there is an abnormally low platelet count. A normal platelet count ranged from 150,000 to 450,000 platelets per micro liter of blood.|Baseline to 28 days after last dose of study drug|FAS included all enrolled participants who received at least 1 dose of the study medication.||Participants|||Number
795173|NCT00913510|Primary|Percent Change From Baseline in Frequency of Micturition Per Day at 8 Weeks.|Number of micturitions per day was assessed using a patient diary during three days at baseline and after 8 weeks of treatment. The relative change in mean number of micturitions was compared between the groups. The change was calculated as percent change = ((measure at 8 weeks - measure at baseline)/measure at baseline)*100%.|Baseline and 8 weeks after randomization.|||percent change||Standard Deviation|Mean
795112|NCT00922779|Secondary|Percentage of Participants With Sustained Virological Response (SVR) at 24 Weeks After End of Therapy|SVR at 24 weeks after end of therapy was defined as a negative result of HCV Ribonucleic Acid (HCV RNA) qualitative assay 24 weeks after end of therapy. Percentage of participants with SVR was calculated as [number of participants with negative results of HCV RNA qualitative assay 24 weeks after end of therapy divided by the total number of participants analyzed] multiplied by 100. The participants who failed to undergo tests at 24 weeks after completion of therapy were considered not amenable to therapy.|24 weeks after end of therapy (Week 72)|Intent-to-treat (ITT) population included all participants who received at least one therapeutic dose of ribavirin.||Percentage of Participants|||Number
795113|NCT00922779|Primary|Number of Participants With Non-Serious Adverse Events (AEs) And Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants with non-serious AEs were exclusive of serious AEs.|From signing of informed consent up to end of study (up to Week 72)|Safety analysis population included all participants who received at least one therapeutic dose of ribavirin.||Participants|||Number
795114|NCT00913081|Primary|Whether Quercetin Dose-dependently Reduces Laser Doppler Flux Index Primary Peak Following Immediate-release Niacin|Laser Doppler flowmetry at the malar eminence measures blood flow quantitatively as red blood cell flux. Flux index is the fold-change in flux over baseline. Flux index primary peak is the maximum flux index between 0-4 hours after niacin.|8 hour period|All subjects who finished at least one visit were analysed.||Fold change over baseline||95% Confidence Interval|Mean
795115|NCT00913133|Secondary|Thrombosis|"New onset symptomatic thrombosis requiring medical or surgical intervention;
Death due to thrombosis defined as fatal pulmonary embolism, ischemic stroke, mesenteric thrombosis or myocardial infarction."|Up until 24 hours after last dose of study drug|Patients who received at least one dose of study drug||participants|||Number
795116|NCT00913133|Primary|Major Bleeding|Major bleeding is defined as clinically evident hemorrhage associated with a hemoglobin decrease ≥2 g/dL that leads to a transfusion of ≥2 units of whole blood or packed red cells outside of the peri-operative period (time from the start of the surgery or procedure and up to 12 hours after), or hemorrhage that is intracranial, retroperitoneal, or into a prosthetic joint.|24 hours after last dose of study drug|All patients receiving at least one dose of study drug||participants|||Number
795117|NCT00913263|Secondary|Number of Days to Prostate Volume Nadir.|Number of Days from day of injection to prostate volume nadir.|Measured every 4th week until progression or maximum 6 months.|||Days||95% Confidence Interval|Median
795118|NCT00913263|Secondary|Percent Change in Prostate Volume From Baseline to Final Visit|Prostate volume was captured at each visit and percent change from baseline to final visit was measured. Final visit was either day of progression or after 6 months. Prostate volume decrease is reported in percent change from baseline|Measured every 4th week until progresion or maximum 6 months.|||percentage change||Standard Deviation|Median
795119|NCT00913263|Secondary|Time to PSA Nadir|Time frame was from baseline to day of PSA nadir.|Measured every 4th week until progression or maximum 6 moths.|||Number of days from baseline to PSA nadi||95% Confidence Interval|Number
795120|NCT00913263|Secondary|Percent Change in Prostate Volume From Baseline to Nadir.|Prostate volume was measured at each visit to capture nadir and compared to baseline for all patients. Decrease in prostate volume is reported as percent change from baseline.|Measured every 4th week until progression or maximum 6 months.|||percent change||Standard Deviation|Median
795121|NCT00913263|Secondary|Number of Patients Reporting Adverse Events Caused by the Study Treatment|"Adverse events caused by the study treatment
Abnormal, clinically relevant, laboratory parameters
Voiding symptoms
Vital Signs
Quality of Life"|Measured every 4th week till progression or maximum 6 months|"All patients who received the single dose of Liproca® Depot and had a baseline plasma PSA measurement, and at least one PSA measurement after the baseline measurement, should be included in the efficacy analysis.
Study population safety All patients who received at least one dose of Liproca® Depot should be included in the safety analysis."||Patients reporting study related AE|||Number
795122|NCT00913263|Primary|Proportion of Patients Showing PSA Nadir|Plasma PSA nadir is the lowest PSA reading achieved after any treatment for prostate cancer. The patients were observed once every 4th week during the study period.|Measured every 4th week until progression or maximum 6 months.|"All patients who received the single dose of Liproca® Depot and had a baseline plasma PSA measurement, and at least one PSA measurement after the baseline measurement, were included in the efficacy analysis.
Study population safety All patients who received at least one dose of Liproca® Depot were included in the safety analysis."||percentage of patients with PSA nadir||95% Confidence Interval|Number
795123|NCT00913380|Secondary|Visualization of the Normal Appendix|Grade 0. Not identified Grade 1. Unsure or partly visualized Grade 2. Clearly and entirely visualized|3 months after CT|"Participants confirmed not to have appendicitis. Intention to treat. Complete case analysis.
There can be missing data if CT report was not made following predefined structured format."||participants|||Number
795124|NCT00913380|Secondary|Diagnosis of Appendiceal Perforation in CT in Patients With Confirmed Appendicitis.|"True positive: Perforation was rated as present in CT report and confirmed as present.
False positive: Perforation was rated as present in CT report and confirmed as absent.
True negative: Perforation was rated as absent in CT report and confirmed as absent.
False negative: Perforation was rated as absent in CT report and confirmed as present.
The data are used to calculate sensitivity and specificity."|3 months after CT|"Participants confirmed to have appendicitis. Intention to treat. Complete case analysis.
There can be missing data if CT report was not made following predefined structured format."||participants|||Number
795125|NCT00913380|Other Pre-specified|Estimate of Carcinogenic Risk Induced by CT Radiation|Age- and sex-specific carcinogenic risk induced by CT radiation. This is not an actual measurement but an estimate of the stochastic risk, based on assumption and calculation from radiation dose used.|1 day after CT||||||
795126|NCT00913380|Other Pre-specified|Radiation Dose|"Radiation dose is measured in terms of dose-length product (mGy•cm) as displayed in the CT console. The length indicates the scan range."|1 day after CT|All participants who underwent CT. Intention to treat. Complete case analysis.||mGy•cm||Inter-Quartile Range|Median
795127|NCT00913380|Secondary|Likelihood of Appendicitis in CT Report in Patients Confirmed as Not Having Appendicitis|"Grade 1. Definitely absent. Clinical observation is recommended. Grade 2. Probably absent. Clinical observation is recommended. Grade 3. Indeterminate. Clinical observation or surgical exploration is recommended.
Grade 4. Probably present. Surgical exploration is recommended. Grade 5. Definitely present. Surgical exploration is recommended. The data are used to calculate sensitivity, specificity, area under receiver-operating-curve and to measure diagnostic confidence."|3 months after CT|"Participants confirmed not to have appendicitis. Intention to treat. Complete case analysis.
There can be missing data if CT report was not made following predefined structured format."||participants|||Number
795128|NCT00913380|Secondary|Likelihood of Appendicitis in CT Report in Patients Confirmed as Having Appendicitis|"Grade 1. Definitely absent. Clinical observation is recommended. Grade 2. Probably absent. Clinical observation is recommended. Grade 3. Indeterminate. Clinical observation or surgical exploration is recommended.
Grade 4. Probably present. Surgical exploration is recommended. Grade 5. Definitely present. Surgical exploration is recommended. The data is used to calculate sensitivity, specificity, area under receiver-operating-curve and to measure diagnostic confidence."|3 months after CT|"Participants confirmed to have appendicitis. Intention to treat. Complete case analysis.
There can be missing data if CT report was not made following predefined structured format."||participants|||Number
795129|NCT00913380|Secondary|Interval From CT to Discharge After Appendectomy|Time interval between the CT acquisition and discharge after appendectomy|3 months after CT|Participants who underwent non-incidental appendectomy. Intention to treat. Complete case analysis.||day||Inter-Quartile Range|Median
795130|NCT00913380|Secondary|Interval Between CT and Discharge Without Surgery|Time interval between the CT acquisition and discharge without surgery|3 months after CT|Participants who did not undergo surgery. Intention to treat. Complete case analysis.||hr||Inter-Quartile Range|Median
795131|NCT00913380|Secondary|Interval Between CT and Appendectomy|Time interval between the CT acquisition and non-incidental appendectomy|1 day after surgery|Participants who underwent non-incidental appendectomy. Intention to treat. Complete case analysis.||hr||Inter-Quartile Range|Median
795132|NCT00913380|Secondary|Appendiceal Perforation|Number of participants with appendiceal perforation|1 week after surgery|Participants confirmed to have appendicitis. Intention to treat. Complete case analysis.||participants|||Number
795133|NCT00913380|Secondary|Additional Imaging Test(s)|Number of participants who need additional imaging test(s) to diagnose or rule out appendicitis|1 week after CT|All participants included in outcome analyses. Intention to treat. Complete case analysis.||participants|||Number
795134|NCT00913380|Primary|Negative Appendectomy|Number of participants with unnecessary appendectomies (removal of un-inflamed appendix)|1 week after surgery|Participants who underwent non-incidental appendectomy. Intention to treat. Complete case analysis.||participants|||Number
795135|NCT00913458|Secondary|Change From Baseline in WPAI Questionnaire: Percent Activity Impairment in the Past 7 Days Due to Problem|"WPAI: 6 question participant rated questionnaire determined the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores = greater impairment and less productivity. The raw (0-10) scores were converted to percent (the variable is named Percent impairment While Working) and as such range from 0 to 100."|64, 76, 91 weeks and Final on Therapy (includes all visits for a participant upto Week 91 or the visit they discontinued at)|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.||Units on a scale||Standard Error|Least Squares Mean
795136|NCT00913458|Secondary|WPAI Questionnaire: Percent Activity Impairment in the Past 7 Days Due to Problem|WPAI: 6 question participant rated questionnaire to determine the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. The raw (0-10) scores are converted to percents (the variable is named “Percent impairment While Working”) and as such range from 0 to 100.|52 weeks|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.||Units on a scale||Standard Deviation|Mean
795137|NCT00913458|Secondary|Change From Baseline in WPAI Questionnaire: Percent Overall Work Impairment in the Past 7 Days Due to Problem|"WPAI: 6 question participant rated questionnaire determined the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores = greater impairment and less productivity. The raw (0-10) scores were converted to percent (the variable is named Percent impairment While Working) and as such range from 0 to 100."|64, 76, 91 weeks and Final on Therapy (includes all visits for a participant upto Week 91 or the visit they discontinued at)|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.||Units on a scale||Standard Error|Least Squares Mean
795138|NCT00913458|Secondary|WPAI Questionnaire: Percent Overall Work Impairment in the Past 7 Days Due to Problem|WPAI: 6 question participant rated questionnaire to determine the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. The raw (0-10) scores are converted to percents (the variable is named “Percent impairment While Working”) and as such range from 0 to 100.|52 weeks|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.||units on a scale||Standard Deviation|Mean
795139|NCT00913458|Secondary|Change From Baseline in WPAI Questionnaire: Percent Impairment While Working in the Past 7 Days Due to Problem|"WPAI: 6 question participant rated questionnaire determined the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores = greater impairment and less productivity. The raw (0-10) scores were converted to percent (the variable is named Percent impairment While Working) and as such range from 0 to 100."|64, 76, 91 weeks and Final on Therapy (includes all visits for a participant upto Week 91 or the visit they discontinued at)|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.||Units on a scale||Standard Error|Least Squares Mean
795140|NCT00913458|Secondary|WPAI Questionnaire: Percent Impairment While Working in the Past 7 Days Due to Problem|WPAI: 6 question participant rated questionnaire to determine the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. The raw (0-10) scores are converted to percents (the variable is named “Percent impairment While Working”) and as such range from 0 to 100.|52 Weeks|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.||units on a scale||Standard Deviation|Mean
795141|NCT00913458|Secondary|Change From Baseline in WPAI Questionnaire: Percent Work Time Missed in the Past 7 Days Due to Problem|"WPAI is a 6 question participant rated questionnaire determined the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores = greater impairment and less productivity. The raw (0-10) scores were converted to percent (the variable is named Percent impairment While Working) and as such range from 0 to 100."|64, 76, 91 weeks and Final on Therapy (includes all visits for a participant upto Week 91 or the visit they discontinued at)|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.||Units on a scale||Standard Error|Least Squares Mean
795142|NCT00913458|Secondary|Work Productivity and Activity Impairment (WPAI) Questionnaire: Percent Work Time Missed in the Past 7 Days Due to Problem|"WPAI: 6 question participant rated questionnaire to determine the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. The raw (0-10) scores are converted to percents (the variable is named Percent impairment While Working) and as such range from 0 to 100."|52 weeks|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.||units on a scale||Standard Deviation|Mean
795143|NCT00913458|Secondary|Change From Baseline mTSS at Week 91 and Final on Therapy|mTSS = sum of erosion and Joint Space Narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change: scores at observation minus score at baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)|||Units on a scale||Standard Error|Least Squares Mean
795144|NCT00913458|Secondary|Modified Total Sharp Score (mTSS) at Week 52|mTSS = sum of erosion and Joint Space Narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change: scores at observation minus score at baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|52 weeks|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.||Units on a scale||Standard Deviation|Mean
795145|NCT00913458|Secondary|Number of Participants Achieving Patient Acceptable Symptom State (PASS)|The PASS is defined as a symptom state that the subjects consider acceptable.|52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.||Participants|||Number
795146|NCT00913458|Secondary|Participant's Global Assessment of Pain (Visual Analogue Scale) (VAS)|100-mm line (Visual Analog Scale) marked by the participant to measure their degree of pain over past 2-3 weeks. Range: 0 = no pain to 100 = pain as bad as it could be.|52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.||mm||Standard Deviation|Mean
795147|NCT00913458|Secondary|Participant's Global Assessment of Disease Activity|Participant’s Global Assessment of Disease Activity was measured on a 0 to 100 mm Visual Analog Scale (VAS), with 0 mm = no disease activity and 100 = extreme disease activity|52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.||Units on a scale||Standard Deviation|Mean
795149|NCT00913458|Secondary|Number of Participants Achieving Complete Response (Using Disease Activity Score Based on a 28-joint Count, Modified Total Sharp Score, Health Assessment Questionnaire)|"The composite measure of complete response over the last 3 months of Phase 2 was defined as:
DAS28 <2.6 at the Week 76 and Week 91 visits and
No radiographic progression during Phase 2, defined as mean change from Week 52 in mTSS of ≤0.5.
Participant must achieve HAQ score ≤0.5 at Week 76 and 91 visits. HAQ is self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ score range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation.A subject had to satisfy all 3 criteria at thevisits to be defined as a responder"|52 and 91 weeks|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.||Participants|||Number
795150|NCT00913458|Secondary|Number of Participants With Disease Activity Score Based on 44-joints Count (DAS44) - Low Disease Activity|DAS44 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 44 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS44 <1.6 = clinical remission, DAS44 ≤2.4 = low disease activity.|52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.||Participants|||Number
795151|NCT00913458|Secondary|Number of Participants With Disease Activity Score Based on 44-joints Count (DAS44) Remission|DAS44 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 44 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS44 <1.6 = clinical remission, DAS44 ≤2.4 = low disease activity.|52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.||Participants|||Number
795152|NCT00913458|Secondary|Number of Participants Achieving American College of Rheumatology 90% (ACR90) Response|ACR90 response: greater than or equal to (≥) 90 percent (%) improvement in tender or swollen joint counts and 90% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.|52, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.||participants|||Number
795153|NCT00913458|Secondary|Number of Participants Achieving American College of Rheumatology 70% (ACR70) Response|ACR70 response: greater than or equal to (≥) 70 percent (%) improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.|52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.||participants|||Number
795154|NCT00913458|Secondary|Number of Participants Achieving American College of Rheumatology 50% (ACR50) Response|ACR50 response: greater than or equal to (≥) 50 percent (%) improvement in tender or swollen joint counts and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.|52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.||participants|||Number
795155|NCT00913458|Secondary|Number of Participants With an American College of Rheumatology 20% (ACR20) Response|ACR20 response: greater than or equal to (≥) 20 percent (%) improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.||participants|||Number
795156|NCT00913458|Secondary|Proportion of Subjects Achieving a Patient Acceptable Symptom State (PASS) at Each Visit|The PASS is defined as a symptom state that the participants consider acceptable.|2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)|Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product||Participants|||Number
795157|NCT00913458|Secondary|Number of Participants With Disease Activity Score Based on 44-joints Count (DAS44) - Low Disease Activity|DAS44 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 44 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS44 <1.6 = clinical remission, DAS44 ≤2.4 = low disease activity.|2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)|Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participant who took at least 1 dose of open-label investigational product||participants|||Number
795158|NCT00913458|Secondary|Number of Participants With Disease Activity Score Based on 44-joints Count (DAS44)-Remission|DAS44 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 44 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS44 <1.6 = clinical remission, DAS44 ≤2.4 = low disease activity.|2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)|Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product||Participants|||Number
795159|NCT00913458|Secondary|Change From Baseline in DAS44 Score at All Visits|DAS44 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 44 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS44 <1.6 = clinical remission, DAS44 ≤2.4 = low disease activity.|2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)|Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product||units on a scale||Standard Deviation|Mean
795160|NCT00913458|Secondary|Change From Baseline in Participant's Global Assessment of Disease Activity|Participant’s Global Assessment of Disease Activity was measured on a 0 to 100 mm Visual Analog Scale (VAS), with 0 mm = no disease activity and 100 = extreme disease activity|2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)|Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product||units on a scale||Standard Deviation|Mean
795161|NCT00913458|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity|Physician Global Assessment of Disease Activity was measured on a 0 to 100 Visual Analog Scale (VAS), with 0 = no disease activity and 100 = extreme disease activity.|2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)|Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product||Units on a scale||Standard Deviation|Mean
795162|NCT00913458|Secondary|Number of Participants Achieving American College of Rhematology 90% (ACR 90) Response|ACR90 response: greater than or equal to (≥) 90 percent (%) improvement in tender or swollen joint counts and 90% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.|2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)|Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product||Participants|||Number
795163|NCT00913458|Secondary|Number of Participants Achieving American College of Rhematology 70% (ACR 70) Response|ACR70 response: greater than or equal to (≥) 70 percent (%) improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.|2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)|Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product||Participants|||Number
795164|NCT00913458|Secondary|Number of Participants Achieving American College of Rhematology 50% (ACR 50) Response|ACR50 response: greater than or equal to (≥) 50 percent (%) improvement in tender or swollen joint counts and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.|2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)|Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product||Participants|||Number
795165|NCT00913458|Secondary|Number of Participants Achieving American College of Rhematology 20% (ACR 20) Response|ACR20 response: greater than or equal to (≥) 20 percent (%) improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.|2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)|Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product||Participants|||Number
795166|NCT00913458|Secondary|Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire: Percent Activity Impairment Due to Problem|"WPAI:6 question participant rated questionnaire to determine the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Four scores are derived:percentage of absenteeism, percentage of presenteeism (reduced productivity while at work),overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. The raw scores (0-10) are converted to percents (the variable is named Percent impairment While Working) and as such range from 0 to 100."|13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)|Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product||units on a scale||Standard Deviation|Mean
795167|NCT00913458|Secondary|Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire: Percent Work Time Missed Due to Problem|"WPAI:6 question participant rated questionnaire to determine the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Four scores are derived:percentage of absenteeism, percentage of presenteeism (reduced productivity while at work),overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. The raw scores (0-10) are converted to percents (the variable is named Percent impairment While Working) and as such range from 0 to 100."|13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)|Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product||units on a scale||Standard Deviation|Mean
795168|NCT00913458|Secondary|Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire: Percent Impairment While Working Due to Problem|"WPAI:6 question participant rated questionnaire to determine the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Four scores are derived:percentage of absenteeism, percentage of presenteeism (reduced productivity while at work),overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. The raw scores (0-10) are converted to percents (the variable is named Percent impairment While Working) and as such range from 0 to 100."|13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)|Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product||units on a scale||Standard Deviation|Mean
795169|NCT00913458|Secondary|Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire: Percent Overall Work Impairment Due to Problem|"WPAI:6 question participant rated questionnaire to determine the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Four scores are derived:percentage of absenteeism, percentage of presenteeism (reduced productivity while at work),overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. The raw scores (0-10) are converted to percents (the variable is named Percent impairment While Working) and as such range from 0 to 100."|13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)|Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product||units on a scale||Standard Deviation|Mean
795170|NCT00913458|Secondary|Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52 and Final on Therapy|mTSS = sum of erosion and Joint Space Narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change: scores at observation minus score at baseline. An increase in mTSS from baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|52 week and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)|Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product||Units on a scale||Standard Deviation|Mean
795171|NCT00913458|Secondary|Number of Participants Achieving Complete Response (Using Disease Activity Score Based on 28-joint Count, Modified Total Sharp Score, Health Assessment Questionnaire)|"The composite measure of complete response over the last 3 months of Phase 1 was defined as:
DAS28 <2.6 at the week 39 and 52 visits and,
No radiographic progression during Phase 1, defined as mean change in modified total Sharp score (mTSS) ≤0.5 and,
Health Assessment Questionnaire (HAQ) ≤ 0.5 at the week 39 and week 52 visits"|End of Phase 1|Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product||Participants|||Number
795172|NCT00913458|Primary|Number of Participants That Met Sustained Remission at Week 76 and Week 91 Based on DAS28 Score|"Sustained remission was defined as a DAS28 <2.6 at the Week 76 and Week 91 visits without requiring a corticosteroid boost between the Week 52 and Week 64 visits, where the requirement for a corticosteroid boost was defined as a value of DAS28 >3.2 at either the Week 56 or Week 64 visit.
DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity.
The participants who met sustained remission in both Week 76 and 91 are presented here."|76 and 91 weeks|Modified intent-to-treat (mITT) population, which included all participants who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.||Participants|||Number
795174|NCT00913523|Secondary|Changes in Nugent Score|Percentage of subjects who showed a change in Nugent score from a score of </= 3 to a score of >/= 4.|Mid-Cycle Baseline to Post-Menstrual Samples|Microbiological analyses are for the “per protocol” population, and no data imputation was performed. Analysis was limited to those subjects whose samples were viable for culture upon receipt at the laboratory.||Percentage of Participants|||Number
795175|NCT00913523|Secondary|Changes in Nugent Score|Percentage of subjects who showed a change in Nugent score from a score of </= 3 to a score of >/= 4.|Mid-Cycle Baseline to Mid-Menstrual Samples|Microbiological analyses are for the “per protocol” population, and no data imputation was performed. Analysis was limited to those subjects whose samples were viable for culture upon receipt at the laboratory.||Percentage of Participants|||Number
795176|NCT00913523|Secondary|Abundance of Selected Microflora in Tampons|Abundance of selected relevant microorganisms in tampons during menses, in log10 colony forming units (CFU) per gram of menstrual fluid add-on to the tampon, in subjects who had detectable counts of the microorganism.|During Menses|Microbiological analyses are for the “per protocol” population, and no data imputation was performed. Analysis was limited to those subjects whose samples were viable for culture upon receipt at the laboratory.||CFU/gm||Standard Deviation|Mean
795177|NCT00913523|Secondary|Percentage of Subjects With Selected Microflora in Tampons|Percentage of subjects with selected relevant microorganisms in tampons during menses|During Menses|Microbiological analyses are for the “per protocol” population, and no data imputation was performed. Analysis was limited to those subjects whose samples were viable for culture upon receipt at the laboratory.||Percentage of Participants|||Number
795178|NCT00913523|Secondary|Percentage of Subjects Showing Unfavorable Changes in Primary Microflora|Percentage of subjects showing unfavorable changes of at least 1-log in lactobacilli (decrease), C. albicans (increase), or G. vaginalis (increase)|Mid-Cycle Baseline to Post-Menstrual Samples|Microbiological analyses are for the “per protocol” population, and no data imputation was performed. Analysis was limited to those subjects whose samples were viable for culture upon receipt at the laboratory.||Percentage of Participants|||Number
795179|NCT00913523|Primary|Percentage of Subjects Showing Unfavorable Changes in Primary Microflora|Percentage of subjects showing unfavorable changes of at least 1-log in lactobacilli (decrease), C. albicans (increase), or G. vaginalis (increase)|Mid-Cycle Baseline to Mid-Menstrual Samples|Microbiological analyses are for the “per protocol” population, and no data imputation was performed. Analysis was limited to those subjects whose samples were viable for culture upon receipt at the laboratory.||Percentage of Participants|||Number
795180|NCT00913692|Secondary|Does Oral Glutamine Reduce the Area of Recurrent Lesions?|During all phases of the study, participants returned to clinic whenever they had a herpes labialis outbreak for staff to assess, obtain a viral swab and document. If unable to return to clinic in the time frame specified in the protocol, participants would take a photo and obtain a swab of the lesion. The number of recurrences, start and end dates of each recurrence and measurement of each lesion during each phase of the study would be documented.|The screening phase time frame was 4 months. Treatment phase 1 was 5 months. Washout phase was 2 weeks. Treatment phase 2 was 5 months.|One participant completed the study and one participant started the 1st treatment phase, but was withdrawn during the first treatment phase, hence the secondary outcomes could not be measured and analyzed.||mm squared||Standard Deviation|Median
795181|NCT00913692|Secondary|Does Oral Glutamine Reduce the Duration of Recurrences?|During all phases of the study, participants returned to clinic whenever they had a herpes labialis outbreak for staff to assess, obtain a viral swab and document. If unable to return to clinic in the time frame specified in the protocol, participants would take a photo and obtain a swab of the lesion. The number of recurrences and start and end dates of each recurrence would be documented.|The screening phase time frame was 4 months. Treatment phase 1 was 5 months. Washout phase was 2 weeks. Treatment phase 2 was 5 months.|One participant completed the study and one participant started the 1st treatment phase, but was withdrawn during the first treatment phase, hence the secondary outcomes could not be measured and analyzed.||days||Standard Deviation|Median
795182|NCT00913692|Secondary|Does Oral Glutamine Reduce the Time to First Recurrence of Herpes Labialis Diagnosed by Clinical and Microbiologic Criteria or Diagnosed by Clinical Criteria With or Without PCR Confirmation?|During all phases of the study, participants returned to clinic whenever they had a herpes labialis outbreak for staff to assess, obtain a viral swab and document. If unable to return to clinic in the time frame specified in the protocol, participants would take a photo and obtain a swab of the lesion. The number of recurrences and start and end dates of each recurrence would be documented during each phase of the study.|The screening phase time frame was 4 months. Treatment phase 1 was 5 months. Washout phase was 2 weeks. Treatment phase 2 was 5 months.|One participant completed the study and one participant started the 1st treatment phase, but was withdrawn during the first treatment phase, hence the secondary outcomes could not be measured and analyzed.||days||Standard Deviation|Median
795183|NCT00913692|Secondary|Does Oral Glutamine Reduce the Number of Clinical Recurrences of Herpes Labialis With or Without PCR Confirmation?|During all phases of the study, participants returned to clinic whenever they had a herpes labialis outbreak for staff to assess, obtain a viral swab and document. If unable to return to clinic in the time frame specified in the protocol, participants would take a photo and obtain a swab of the lesion. The number of recurrences would be documented during each phase of the study.|The screening phase time frame was 4 months. Treatment phase 1 was 5 months. Washout phase was 2 weeks. Treatment phase 2 was 5 months.|One participant completed the study and one participant started the 1st treatment phase, but was withdrawn during the first treatment phase, hence the secondary outcomes could not be measured and analyzed.||herpes labialis lesions||Standard Deviation|Median
795184|NCT00913692|Primary|Does Oral Glutamine Reduce the Number of Recurrences of Herpes Labialis, Diagnosed by Clinical and Microbiologic Criteria, in Healthy Participants With Frequently Recurrent Disease.|During all phases of the study, participants returned to clinic whenever they had a herpes labialis outbreak for staff to assess, obtain a viral swab and document. If unable to return to clinic in the time frame specified in the protocol, participants would take a photo and obtain a swab of the lesion. The number of outbreaks would be measured during each phase.|The screening phase time frame was 4 months. Treatment phase 1 was 5 months. Washout phase was 2 weeks. Treatment phase 2 was 5 months.|One participant completed the study and one participant started the 1st treatment phase, but was withdrawn during the first treatment phase, hence the primary outcome could not be measured and analyzed.||herpes labialis lesions|||Number
811070|NCT01051778|Secondary|IUFD||Pregnancy >24 weeks gestation||||||
795185|NCT00913744|Primary|Proportion of Subjects With Focal Vitreomacular Adhesion (VMA) Release by Day 28|The VMA release was determined by masked Central Reading Center Optical Coherence Tomography (OCT) evaluation|Day 28|The Full Analysis Set (FAS) was the primary data set for efficacy analysis. Data that were missing for any reason were imputed using the Last Observation Carried Forward (LOCF) method.||percentage of subjects|||Number
795186|NCT00913770|Secondary|Days of Self-reported Illicit Opioid Use in the Past 7 Days||30 days post randomization|All subjects who were randomized to receive treatment were included in the primary analysis. 2 subjects were lost to follow up in the standard of care arm which is why 102 are included in the analysis instead of 104||Mean Number of Days||95% Confidence Interval|Mean
795187|NCT00913770|Primary|Self-reported Engagement in Formal Substance Abuse Treatment at 30 Days (Verified by Contact With the Treatment Program)|Defined as enrollment and receiving formal addiction treatment on the 30th day following randomization. This is assessed by direct contact with facility, clinician, or both.|30 days post randomization|All subjects who were randomized to receive treatment were included in the primary analysis. 2 subjects were lost to follow up in the standard of care arm which is why 102 are included in the analysis instead of 104||Mean Number of Outpatient Visits||95% Confidence Interval|Mean
795188|NCT00913835|Secondary|PFS for Participants Who Had Tissue Samples for Platelet Derived Growth Factor Receptor Alpha (PDGFRα) Expression Determined by Immunohistochemistry (IHC) (Association Between PDGFRα Tumor Expression and PFS)|PFS is defined as the time from the day of randomization to the first evidence of progression as defined by RECIST v1.0 criteria or death from any cause. PD is a 20% increase over the smallest sum of target lesions or new lesions. Participants who died without a prior disease progression were considered to have progressed on the day of their death. Participants who did not progress and were subsequently lost to follow-up had their data censored at the day of last tumor assessment. PDGFRα protein expression at baseline in tumor cells is determined by IHC using H-Scores and a cut point of 0. Participants were considered to have a high relative expression when H-Score is >0 and a low relative expression when H-Score=0. H-Score was calculated by summing the percentage of cell staining at each intensity multiplied by the weighted intensity of staining. Staining intensity: 0 (no staining), 1+ (weak staining), 2+ (medium staining), 3+ (strongest staining). H-Scores could range from 0-300.|Randomization to PD or Date of Death (Up to 130 Weeks)|All participants who had evaluable PDGFRα results.||weeks||95% Confidence Interval|Median
795189|NCT00913835|Secondary|Apparent Volume of Distribution (Vss) of Olaratumab|Vss is an estimate of drug distribution independent of the elimination process and is proportional to the amount of drug in the body versus the drug plasma concentration at steady-state.|Prior to and 1 h after Olaratumab Infusion in Cycles 1, 2, and 4 and 48 h or 72 h, 144 h, 240 h or 264 h and 336 h Post-dose in Cycles 1 and 4 (28-day Cycles)|Zero participants were analyzed. An insufficient amount of samples were collected to derive this measure.|||||
795190|NCT00913835|Secondary|Clearance (CL) of Olaratumab|CL is the volume of serum cleared of Olaratumab per unit of time after a single dose of Olaratumab|Prior to and 1 h after Olaratumab Infusion in Cycles 1, 2, and 4 and 48 h or 72 h, 144 h, 240 h or 264 h and 336 h Post-dose in Cycles 1 and 4 (28-day Cycles)|Zero participants were analyzed. An insufficient amount of samples were collected to derive this measure.|||||
795191|NCT00913835|Secondary|Half-life (t1/2) of Olaratumab|The time it takes to reduce the concentration of Olaratumab in the plasma by 50%.|Prior to and 1 h after Olaratumab Infusion in Cycles 1, 2, and 4 and 48 h or 72 h, 144 h, 240 h or 264 h and 336 h Post-dose in Cycles 1 and 4 (28-day Cycles)|Zero participants were analyzed. An insufficient amount of samples were collected to derive this measure.|||||
795192|NCT00913835|Secondary|Maximum Concentration (Cmax) of Olaratumab||Prior to and 1 h after Olaratumab Infusion in Cycles 1, 2, and 4 and 48 h or 72 h, 144 h, 240 h or 264 h and 336 h Post-dose in Cycles 1 and 4 (28-day Cycles)|Zero participants were analyzed. An insufficient amount of samples were collected to derive this measure.|||||
795193|NCT00913835|Secondary|Area Under the Curve (AUC) of Olaratumab||Prior to and 1 Hour (h) After Olaratumab Infusion in Cycles 1, 2, and 4 and 48 h or 72 h, 144 h, 240 h or 264 h and 336 h Post-dose in Cycles 1 and 4 (28-day Cycles)|Zero participants were analyzed. An insufficient amount of samples were collected to derive this measure.|||||
795194|NCT00913835|Secondary|PFS of Participants Who Received Olaratumab After Liposomal Doxorubicin Monotherapy (Descriptive Statistics for Safety and Efficacy for Participants Who Continue on Olaratumab Monotherapy Following Disease Progression on Liposomal Doxorubicin Monotherapy)|PFS is defined as the time from start of Olaratumab monotherapy to the first evidence of progression as defined by RECIST v1.0 criteria or death from any cause. PD is a 20% increase over the smallest sum of target lesions or new lesions. Participants who died without a reported prior disease progression were considered to have progressed on the day of their death. Participants who did not progress and were subsequently lost to follow-up had their data censored at the day of last tumor assessment.|From Start of Olaratumab Monotherapy to PD or Date of Death (Up to 20 Weeks)|Participants who received Olaratumab treatment after PD on liposomal doxorubicin monotherapy. Participants censored=4||weeks||90% Confidence Interval|Median
795195|NCT00913835|Secondary|Percentage of Participants With Anti-Olaratumab Antibodies|Participants with Treatment Emergent (TE) anti-olaratumab antibodies were participants with a 4-fold increase (2 dilutions) increase over a positive baseline antibody titer or for a negative baseline titer, a participant with an increase from the baseline to a level of 1:20.|Baseline Up to 30-Day Postdose Follow-Up (Up To 35 Months)|All randomized participants who received at least one dose of study drug and had evaluable baseline and evaluable post-baseline antibody data.||percentage of participants|||Number
795196|NCT00913835|Secondary|Number of Participants With Adverse Events (AEs) and Who Died|Reported are the number of participants with clinically significant events, defined as serious AEs (SAEs) and other non-serious AEs regardless of causality and those who died during treatment and during the 30-day post-dose follow-up. A summary of SAEs and other non-serious AEs regardless of causality is located in the Reported Adverse Events module of this report.|Baseline Up to End of Treatment and 30-day Post-dose Follow-up (Up to 35 Months)|All randomized participants who received any amount of study drug.||participants|||Number
795266|NCT00914862|Primary|Apparent Volume of Distribution (Vz/F)|Vz/F is the distribution of a drug between plasma and the rest of the body following oral administration, calculated as Vz/F = Apparent oral clearance (CL/F) / Terminal elimination rate constant (λz).|Day 1: predose (within 1 hour prior to dose) and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 16 hours post-dose.|Pharmacokinetic set where valid PK parameter estimates were available.||Liters||Standard Deviation|Mean
795197|NCT00913835|Secondary|Median Duration of Response|Duration of response is the interval from the date of initial CR or PR until the first date criteria for PD is met using RECIST v1.0 criteria, or initiation of other (or additional) antitumor therapy is first reported, or death due to any cause. CR is the disappearance of all target and non-target lesions and the normalization of tumor marker levels. PR is a ≥30% decrease in the sum of the LD of target lesions without new lesions and progression of non-target lesions. PD is a ≥20% increase in the sum of the LD of target lesions and/or unequivocal progression of existing non-target lesions and/or detection of 1 or more new lesions. Participants who did not relapse were censored on the day of their last tumor assessment.|Date of Initial CR or PR to PD (Up to 35 Months)|All participants who achieved CR or PR. Participants censored: Olaratumab=2, Liposomal Doxorubicin=4.||weeks||90% Confidence Interval|Median
795198|NCT00913835|Secondary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]|The percentage of participants with a best overall response of confirmed CR or PR defined using RECIST v1.0 criteria. CR is the disappearance of all target and non-target lesions and normalization of cancer antigen-125 (CA-125) levels. PR is defined as having a ≥30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. The percentage of participants with objective response was calculated as: (number of participants whose best overall response of CR or PR/number of participants treated) * 100.|Randomization to PD (Up to 35 Months)|mITT Population: All randomized participants who received any amount of study drug.||percentage of participants||90% Confidence Interval|Number
795199|NCT00913835|Secondary|Overall Survival (OS)|OS is defined as the time from first day of therapy to the date of death from any cause. Participants who were alive at the end of the follow-up period or were lost to follow-up, OS was censored on the last date the participant was known to be alive.|First Day of Therapy to Date of Death (Up to 35 Months)|mITT Population: All randomized participants who received any amount of study drug. Participants censored: Olaratumab=21, Liposomal Doxorubicin=23.||weeks||90% Confidence Interval|Median
795200|NCT00913835|Primary|Progression-Free Survival (PFS)|PFS is defined as the time from the day of randomization to the first evidence of progression as defined by Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0) criteria or death from any cause. Progressive Disease (PD) is a 20% increase over the smallest sum of target lesions or new lesions. Participants who died without a reported prior disease progression were considered to have progressed on the day of their death. Participants who did not progress and were subsequently lost to follow-up had their data censored at the day of last tumor assessment.|Randomization to Progressive Disease (PD) or Date of Death (Up to 35 Months)|Modified Intent to Treat (mITT) Population: All randomized participants who received any amount of study drug. Participants censored: Olaratumab=13, Liposomal Doxorubicin=14.||weeks||90% Confidence Interval|Median
795201|NCT00913913|Other Pre-specified|Clinical Response|clinical response by RECIST 1.1|Day 70|||participants|||Number
795202|NCT00913913|Other Pre-specified|Measure of Percent of CD4 and CD8 Lymphocyte Subsets|percent of CD4 and CD8 positive lymphocyte subsets|Baseline, day 28, day 70|Peripheral blood lymphocyte subsets: 5 subjects at baseline and same 5 at day 70. 6 subjects analyzed at day 28||percentage of total lymphocytes||Full Range|Mean
795203|NCT00913913|Secondary|To Characterize the Number of Participants With Clinical and Autoimune Related Toxicity of Treatment|To characterize the clinical and autoimmune related toxicity profile of the combined treatment regimen using CTCAE 3. Toxicity reported are those expected from high dose IL-2 and were not considered adverse events.|5 years|||participants|||Number
795204|NCT00913913|Primary|Progression Free Survival|median progression free survival|5 years|||DAYS||Full Range|Median
795205|NCT00914069|Secondary|Summary of Minor Complications|Any device-related or procedure-related adverse event that causes clinically inconsequential symptoms to the patient.|Post-PIV placement until catheter removal (usually within 4 days)|||participants|||Number
795206|NCT00914069|Secondary|Second Stick Success Rate|A secured flushed IV will be indicative of a successful PIV placement.|An access attempt usually ranges from 0 to 45 minutes in duration.|Number of Participants Analyzed is not consistent with numbers provided in the Participant Flow Module because not all participants required a second attempt at catheter placement.||participants|||Number
795207|NCT00914069|Secondary|Time Required to Obtain Access|A secured flushed IV will be indicative of a successful PIV placement.|An access attempt usually ranges from 0 to 45 minutes in duration.|||minutes||Standard Deviation|Mean
795208|NCT00914069|Primary|Summary of Major Complications|Any device-related or procedure-related adverse event that causes clinically consequential symptoms to the patient. These may include access site hematoma, bleeding, infection, nerve injury, vessel laceration, wound dehiscence, allergic reaction, or inflammation, among others.|Post-PIV placement until catheter removal (usually within 4 days)|||participants|||Number
795209|NCT00914069|Primary|IV Insertion Success Rate at First Attempt IV Insertion Success Rate at First Attempt|A successful IV insertion includes all of the following: initial vein penetration, which is visualized by a flash back of blood into the access device, deployment of the guidewire, advancement of the catheter into the vein, retraction of needle and guidewire, and flushing of IV. A secured flushed IV will be indicative of a successful PIV placement.|An access attempt usually ranges from 0 to 45 minutes in duration.|||participants|||Number
795210|NCT00914186|Primary|Number of Participants Who Had Measurable Pruritis Based on a Visual Horizontal Analog Scale|"Pruritis Visual Analog Scale (VAS) based on patient reported outcome of pruritis measurement on a VAS indicating the amount of pruritus (itchiness) experienced from the time of last dose application through the time just before current dose application. Change in pruritus is assessed twice daily beginning at baseline, Study Day -7 (Visit 2), through Study Day 36 (Visit 7). Subjects determine measurable pruritis using a visual horizontal analog scale ranging from No Itch, even the slightest itch or Slight Itch, to Worst Itch Imaginable to denote the increase in severity of itching."|Baseline through Study Day 36 (Visit 7)|||participants|||Number
795242|NCT00914589|Secondary|Percentage of Subjects With rFXIII Antibody Reaction|Immunogenicity as number of subjects who manifested FXIII antibody reaction until end of trial. The percentage may be derived from the number of subjects treated with rFXIII with available antibody measurement at visit 8.|measured from screening until 5-7 weeks post Trial Drug Administration|Safety analysis set includes all subj. exposed to at least one dose of trial product. 1 subj with a low titre antibody at baseline was also reported with low titre FXIII antibody at visit 8. 27, 19 and 17 subjects in placebo, FXIII 17.5 and 35 IU/KG, respectively, did not have antibody measurement.||participants|||Number
795211|NCT00914186|Primary|Skindex-29 Questionnaire to Measure the Subject’s Overall Quality of Life Based on Activities of Daily Living That Affect Change in Emotion (10 to 50 Points), Symptoms (7 to 35 Points) and Functioning (12 to 60 Points) to Skin Over One Week Period.|Assessment of subject's activities of daily living using the SKINDEX-29 questionnaire to measure the subject’s overall quality of life based on a change in scale from baseline. The SKINDEX scoring scale has a range of 29-145. The smaller the number the better the patient feels. The results are the difference of the SKINDEX scoring scale at treatment discharge (day 22) minus baseline (day-7). Hence the results should be negative, as the patient's emotion, symptoms and functioning of the skin should feel better at treatment discharge as opposed to baseline.|Study Day -7 through Study Day 22|ITT||units on a scale||Standard Deviation|Mean
795212|NCT00914186|Primary|Eczema Area and Severity Index (EASI) Based on a Change in Score of Eruption in Proportionate Body Surface Areas|The head and neck [10%], trunk [30%], upper extremities [20%] and lower extremities [40%] were assessed separately for erythema (E), infiltration/papulation (I), excoriation (Ex) and lichenification (L) represented by a numeric coded value of (0, No eruption) to (6, 90% - 100% eruption). One score given to each part of the body on a scale from 1-6 based on the four attributes (E, I, Ex, L) and then a proportional average is taken to get a total score of 1-6.|baseline through Study Day 36 (Visit 7)|ITT analysis||units on a scale||Standard Deviation|Mean
795213|NCT00914186|Primary|Five Point Pruritus Scale for Self-Assessment of Target Treatment Area Based on a Change in Score|self-assessment using a five point scale of pruritus state based on a change in scale from none (0) to very severe (4), interfering with daily or sleep activities. Subjects will complete the Five-Point Pruritus Scale once at Screening (Visit 1), then twice daily beginning at baseline, which occurs on the morning of Study Day -7 (Visit 2), through Study Day 36 (Visit 7)|Baseline, which is Day -7 (Visit 2), through Day 36 (Visit 7)|ITT||units on a scale||95% Confidence Interval|Mean
795214|NCT00914186|Primary|Investigator's Global Assessment (IGA) Based on a Dermatologist's Evalution of the Change in Subject's Score of Target Treatment Areas|investigator assessment of disease status rated on 0-5 scale (0 = clear to 5 = very severe) based on a change in score from baseline to Study Day 36 (Visit 7)|baseline through Study Day 36 (Visit 7)|ITT||units on a scale||95% Confidence Interval|Mean
795215|NCT00914186|Primary|Safety and Tolerability of TS-022 Topical Lotion as Measured by Participants Who Demonstrated Adverse Events|Safety assessment of all subjects who received investigational product. Outcome measure is number of subjects with an adverse event. Measures of adverse events in participants included vital signs, laboratory findings, physical exams, electrocardiograms|Baseline through Study Day 36 (Visit 7)|total number of subjects who received study drug.||participants|||Number
795216|NCT00914186|Primary|Change in Pruritis Visual Analog Scale (VAS)|Patient reported outcome of pruritis measurement (0-100 mm/min-max)on a change in visual analog scale|Baseline through Study Day 36 (Visit 7)|Intent To Treat (ITT) analysis||mm||Standard Deviation|Mean
795217|NCT00914316|Secondary|Percentage Increase in Absolute Walking Distance Following Phase 2|Change in absolute walking distance in meters from baseline to 24 week follow-up treadmill test, as a percentage from baseline treadmill test|24 weeks|Missing data from one subject 24 week treadmill test in placebo/placebo group||percentage of baeline||Inter-Quartile Range|Median
795218|NCT00914316|Primary|Percentage Increase in Absolute Walking Distance Following Phase 1|Change in absolute walking distance in meters from baseline to 12 week follow-up treadmill test, as a percentage from baseline treadmill test|12 weeks|Missing data for 12 week test in 1 subject in Ranolazine/Ranolazine group, 1 subject in Ranolazine/placebo group, and 3 subjects in placebo/placebo group||percentage of baseline||Inter-Quartile Range|Median
795219|NCT00914459|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): All Participants|An adverse event (AE) was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.|Baseline up to 30 days after last study visit (Month 25)|Safety analysis population included all enrolled participants who received at least 1 dose of ReFacto AF.||participants|||Number
795220|NCT00914459|Secondary|Mean Residence Time (MRT) of ReFacto AF|MRT was calculated as AUMCinf / AUCinf-TI/2, where AUMCinf is the area under the first moment curve from time zero to infinity and TI was the duration of infusion.|Pre-dose, 0.5, 1, 3, 6, 9, 24, 28, 32, 48 hours post-dose on Day 1|"PK parameter analysis population included all enrolled participants who received at least 1 dose of ReFacto AF. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Data was not planned to be collected and analyzed for reporting arm “ReFacto AF: Less Than 6 Years”, as pre-specified in protocol."||hour||Full Range|Median
795221|NCT00914459|Secondary|Volume of Distribution at Steady State (Vss)|Volume of distribution was defined as the theoretical volume in which the total amount of drug was uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) was the apparent volume of distribution at steady-state.|Pre-dose, 0.5, 1, 3, 6, 9, 24, 28, 32, 48 hours post-dose on Day 1|"PK parameter analysis population included all enrolled participants who received at least 1 dose of ReFacto AF. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Data was not planned to be collected and analyzed for reporting arm “ReFacto AF: Less Than 6 Years”, as pre-specified in protocol."||mL/kg||Geometric Coefficient of Variation|Geometric Mean
795222|NCT00914459|Secondary|Area Under the Plasma Time Curve From Time Zero to Time of Last Measurable Concentration (AUClast)|AUClast is the area under the plasma versus time curve from time zero to time of last measurable concentration (AUClast)|Pre-dose, 0.5, 1, 3, 6, 9, 24, 28, 32, 48 hours post-dose on Day 1|"PK parameter analysis population included all enrolled participants who received at least 1 dose of ReFacto AF. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Data was not planned to be collected and analyzed for reporting arm “ReFacto AF: Less Than 6 Years”, as pre-specified in protocol."||IU*hr/mL||Geometric Coefficient of Variation|Geometric Mean
796270|NCT00928408|Primary|Cinacalcet Dosing Frequency|Cinacalcet dosing frequency at Month 12|Month 12|Full Analysis Set - Participants with Observed Data||Participants|||Number
795223|NCT00914459|Secondary|Area Under the Plasma Time Curve From Time 0 Extrapolated to Infinite Time (AUCinf)|AUCinf is the area under the plasma concentration-time profile from time 0 extrapolated to infinite time. It was calculated as International units*hour per milliliter (IU*hr/mL).|Pre-dose, 0.5, 1, 3, 6, 9, 24, 28, 32, 48 hours post-dose on Day 1|"PK parameter analysis population included all enrolled participants who received at least 1 dose of ReFacto AF. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Data was not planned to be collected and analyzed for reporting arm “ReFacto AF: Less Than 6 Years”, as pre-specified in protocol."||IU*hr/mL||Geometric Coefficient of Variation|Geometric Mean
795224|NCT00914459|Secondary|Plasma Concentration of Factor VIII at 0.5 Hour Post-dose (C0.5)||0.5 hour post-dose on Day 1|The PK parameter analysis population included all enrolled participants who received at least 1 dose of ReFacto AF.||IU/mL||Geometric Coefficient of Variation|Geometric Mean
795225|NCT00914459|Secondary|Number of Participants Requiring Escalated Dose of Prescribed Regimen During the Treatment Period: All Participants|Participants who met the dose escalation criteria were prescribed a higher dose and/or more frequent doses as per the investigator’s discretion.|Baseline up to Month 24|Efficacy analysis population included all enrolled participants who received at least 1 dose of ReFacto AF. Participants who used a prophylaxis regimen were analyzed for this outcome measure.||participants|||Number
795226|NCT00914459|Secondary|Number of Occurrences of Less-Than-Expected-Therapeutic Effect (LETE) in the Low Recovery Setting: All Participants|LETE in the low recovery setting was defined as lower than expected recovery of FVIII (in the opinion of investigator), following the infusion of ReFacto AF in the absence of confounding factors for the low recovery. The only confounding factors for low recovery are as follows: known presence or subsequent identification of a FVIII inhibitor, known compromised ReFacto AF, faulty administration of ReFacto AF, including inadequate dosing.|Baseline up to Month 24|Efficacy analysis population included all enrolled participants who received at least 1 dose of ReFacto AF.||LETE bleeds|||Number
795227|NCT00914459|Secondary|Number of Less-Than-Expected-Therapeutic Effect (LETE) Bleeds in the Prophylaxis Setting: All Participants|LETE in the prophylaxis setting occurred if there was a spontaneous bleed within 48 hours (<=48 hours) after a regularly scheduled prophylactic dose of ReFacto AF (which was not used to treat a bleed) in the absence of confounding factors. Therefore, LETE in the prophylaxis setting is the occurrence of a bleed. Confounding factors include: Known presence or subsequent identification of a FVIII inhibitor, known inadequate prophylactic dose, known lack of adherence to the prescribed prophylaxis regimen, bleed occurs in a target joint identified at the start of the study, known compromised ReFacto AF, faulty administration of ReFacto AF, an underlying, predisposing condition responsible for the bleed in the opinion of the investigator (e.g., kidney stones or use of medications known to impair platelet function, such as aspirin or NSAIDs) or traumatic injury responsible for bleeding.|Baseline up to Month 24|Efficacy analysis population included all enrolled participants who received at least 1 dose of ReFacto AF. Participants who received at least 1 prophylaxis dose of ReFacto AF were reported.||LETE bleeds|prophylaxis infusions||Number
795228|NCT00914459|Secondary|Number of Less-Than-Expected-Therapeutic Effect (LETE) Bleeds in the On-Demand Setting: All Participants|"LETE in on-demand setting was based on response to treatment of a bleeding episode. LETE in the on-demand setting occurred if participant recorded 2 successive no response ratings after 2 successive ReFacto AF infusions. Both infusions were to be administered at an interval of 24 hours for treatment of same bleeding event in absence of confounding factor which included: known presence or subsequent identification of a FVIII inhibitor, known inadequate dose for type and/or severity of bleed in opinion of investigator, delay of greater than 4 hours between onset of bleed to infusion, delay of greater than 24 hours before administration of a follow-up infusion, known compromised ReFacto AF, faulty administration of ReFacto AF, participant had an underlying, predisposing condition responsible for bleed in opinion of investigator (e.g., kidney stones or use of medications known to impair platelet function, such as aspirin or NSAIDs),or ongoing trauma responsible for continued bleeding."|Baseline up to Month 24|Efficacy analysis population included all enrolled participants who received at least 1 dose of ReFacto AF. Here, “number of participants analyzed” signifies participants who were evaluable for this outcome measure and received treatment for at least one bleed.||LETE bleeds|bleeding episodes||Number
795229|NCT00914459|Secondary|Total Factor VIII Consumption: All Participants|Total factor VIII consumption for each participant was calculated by sum of the total amount of ReFacto AF (in IU) infused for each ReFacto AF infusion (recorded in the infusion log diary CRF). Data was reported separately for participants classified at baseline as following non-prophylaxis regimen (for example: on-demand regimen, preventive, or not specified), and participants classified at baseline following a primary or secondary prophylaxis regimen.|Baseline up to Month 24|"Efficacy analysis population included all enrolled participants who received at least 1 dose of ReFacto AF. Here, n signifies participants who were evaluable for each specified baseline category."||IU||Standard Deviation|Mean
795230|NCT00914459|Secondary|Average Infusion Dose of ReFacto AF: All Participants|The average infusion dose (by weight) for each participant was calculated as his total factor FVIII consumption (in IU) divided by weight (in kg) divided by the number of infusions administered in total study duration. Data was reported separately for participants classified at baseline as following non-prophylaxis regimen (for example: on-demand regimen, preventive, or not specified), and participants classified at baseline following a primary or secondary prophylaxis regimen.|Baseline up to Month 24|"Efficacy analysis population included all enrolled participants who received at least 1 dose of ReFacto AF. Here, n signifies participants who were evaluable for each specified baseline category."||IU/kg||Standard Deviation|Mean
795231|NCT00914459|Secondary|Number of Breakthrough Bleeds Within 48 Hours of a Prophylaxis Dose of ReFacto AF: All Participants|The number of breakthrough bleeds within 48 hours following a prophylaxis dose of ReFacto AF was summarized. The infusion log diary CRF was used to determine the number of infusions administered to treat a new bleed counting only those infusions which were administered <=48 hours after an infusion marked as “prophylaxis” (which had no associated bleed).|Baseline up to Month 24|Efficacy analysis population included all enrolled participants who received at least 1 dose of ReFacto AF.||breakthrough bleeds||Standard Deviation|Mean
795335|NCT00923247|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE) v4.0. For the detailed list of adverse events see the adverse event module.|7 years and 9 days|No participants were enrolled in the phase IIB cohort.||Participants|||Count of Participants
795232|NCT00914459|Secondary|Number of On-Demand ReFacto AF Infusions to Treat a New Bleed: All Participants|"The infusion log diary case report form (CRF) was used to determine the number of on-demand (administration of an unscheduled bolus infusion of Refacto-AF to stop bleeding) ReFacto AF infusions administered to treat a new bleed. This was calculated by adding the initial for a new bleed (on-demand) infusion to any subsequent (on-demand) infusions for the same previously treated bleed (same bleed with same start date/time)."|Baseline up to Month 24|"Efficacy analysis population included all enrolled participants who received at least 1 dose of ReFacto AF. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure."||infusions|bleeds|Standard Deviation|Mean
795233|NCT00914459|Secondary|Response to First On-Demand Treatment for New Bleeds: All Participants|A 4-point scale of assessment of ‘on-demand’ treatment (administration of an unscheduled bolus infusion of Refacto-AF to stop bleeding) is defined as: 1. Excellent: Definite pain relief and/or improvement in signs of bleeding starting within 8 hours after an infusion, with no additional infusion administered. 2. Good: Definite pain relief and/or improvement in signs of bleeding starting within 8 hours after an infusion, with at least one additional infusion administered for complete resolution of the bleeding episode;or, Definite pain relief and/or improvement in signs of bleeding starting after 8 hours following infusion, with no additional infusion administered. 3. Moderate: Probable or slight improvement starting after 8 hours following the infusion, with at least one additional infusion administered for complete resolution of the bleeding episode. 4. No Response: No improvement at all between infusions or during the 24-hour interval following an infusion, or condition worsens.|Baseline up to Month 24|"Efficacy analysis population included all enrolled participants who received at least 1 dose of ReFacto AF. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure and received at least 1 dose of ReFacto AF for at least one bleeding episode."||responses|bleeds||Number
795234|NCT00914459|Secondary|Mean Annualized Bleeding Rates (ABRs): All Participants|ABR for each participant was calculated as the number of bleeds requiring administration of FVIII replacement product (taken from the Infusion Log Diary case report form), divided by the total therapy duration (in days), then multiplied by 365.25. ABR for the participants who reported following a primary or secondary prophylaxis, on-demand regimen or preventive regimen at baseline were reported.|Baseline up to Month 24|"Efficacy analysis population included all enrolled participants who received at least 1 dose of ReFacto AF. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure and n signifies participants who were evaluable at the specified time points."||bleeds per year||Standard Deviation|Mean
795235|NCT00914459|Primary|Clearance (CL)|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Pre-dose, 0.5, 1, 3, 6, 9, 24, 28, 32, 48 hours post-dose on Day 1|"PK parameter analysis population included all enrolled participants who received at least 1 dose of ReFacto AF. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Data was not planned to be collected and analyzed for reporting arm “ReFacto AF: Less Than 6 Years”, as pre-specified in protocol."||milliliter per hour per kilogram||Geometric Coefficient of Variation|Geometric Mean
795236|NCT00914459|Primary|Terminal Elimination Half Life of ReFacto AF (t1/2)|T1/2 was the time for the plasma concentration of drug to decrease by one-half of its original concentration.|Pre-dose, 0.5, 1, 3, 6, 9, 24, 28, 32, 48 hours post-dose on Day 1|"PK parameter analysis population included all enrolled participants who received at least 1 dose of ReFacto AF. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Data was not planned to be collected and analyzed for reporting arm “ReFacto AF: Less Than 6 Years”, as pre-specified in protocol."||hours||Standard Deviation|Mean
795237|NCT00914459|Primary|Incremental Recovery|Incremental recovery was the increase in circulating FVIII activity for every international unit (IU) of ReFacto AF administered per kilogram of body weight. It was measured in international units per deciliter (IU/dL) per international units per kilogram (IU/kg).|Days 1, 15, 50, Months 6, 18 and Final visit (up to Month 24)|"The pharmacokinetic (PK) parameter analysis population included all enrolled participants who received at least 1 dose of ReFacto AF. Here, n signifies participants who were evaluable at the specified time point for each arm respectively."||(IU/dL)/(IU/kg)||Standard Deviation|Mean
795238|NCT00914459|Primary|Percentage of Participants With Clinically Significant Factor VIII Inhibitor Development|Clinically significant factor VIII (FVIII) inhibitors were defined as a central laboratory confirmed positive inhibitor of greater than or equal to (>=) 0.6 Bethesda units (BU) using the Nijmegen modification of the Bethesda assay present at 2 consecutive blood draws within a 6-week interval and one of the following within 4 weeks before the initial or within 4 weeks following the second positive FVIII inhibitor sample collection: 1) the need for the participant to administer alternative hemostatic products in order to achieve sufficient efficacy, 2) >=2 events indicating a decrease in the efficacy of the study treatment. Percentage of participants who developed clinically significant Factor VIII inhibitor after study drug administration were reported.|Baseline up to Month 24|Safety analysis population included all enrolled participants who received at least 1 dose of ReFacto AF.||percentage of participants||95% Confidence Interval|Number
795239|NCT00914485|Primary|Change in Provider Use of Best Acts From Baseline to Post-Intervention|"Mean per-patient use of best acts learned during provider communication skills intervention, post-intervention minus baseline."|Baseline, 18 months|||best acts per patient||Standard Deviation|Mean
795240|NCT00914589|Secondary|Percentage of Subjects With Serious Adverse Events|Percentage of subjects with serious adverse events until end of trial.|measured from screening until 5-7 weeks post Trial Drug Administration|The safety analysis set included all subjects who were exposed to at least one dose of trial product.||percentage (%) of subjects|||Number
795241|NCT00914589|Secondary|Percentage of Subjects With Critical Adverse Events|Percentage of subjects with critical adverse events (thromboembolic events (AMI, cerebrovascular thromboembolic event, peripheral artery occlusion, DVT, pulmonary embolism), renal dysfunction, re-operation and death) until end of trial|measured from screening until 5-7 weeks post Trial Drug Administration|The safety analysis set included all subjects who were exposed to at least one dose of trial product.||percentage (%) of subjects|||Number
795243|NCT00914589|Secondary|Percentage of Subjects With Thromboembolic Events|Percentage of subjects with thromboembolic events (AMI, cerebrovascular thromboembolic event, peripheral artery occlusion, DVT, pulmonary embolism) until end of trial|measured from screening until 5-7 weeks post Trial Drug Administration|The safety analysis set included all subjects who were exposed to at least one dose of trial product.||percentage of subjects|||Number
795244|NCT00914589|Primary|Percentage of Subjects Avoiding Any Allogeneic Transfusions for Seven Days Post-operative or Until Discharge, Whichever Came First|Proportion of patients avoiding blood products given via allogeneic transfusion. Blood products were defined as any of the following: RBC, platelets, FFP, fibrinogen concentrate and clotting factor(s) concentrate, including cryoprecipitate.|measured ongoing from dosing until day 7 or discharge, whichever came first|Full analysis set consisted of all subjects who were randomised and exposed to randomised treatment.||percentage (%) of subjects|||Number
795245|NCT00914810|Secondary|Change in Blood Level of Vitamin D (25-hydroxyvitamin D)||Baseline and 6 weeks|25-hydroxyvitamin D levels missing for 2 participants in the vitamin D arm of the trial.||ng/mL||Standard Deviation|Mean
795246|NCT00914810|Primary|Change in Short Physical Performance Battery (SPPB) Score|SPPB measures lower extremity strength using 3 simple office-based tests to assess standing balance, gait speed, and chair stands. The composite SPPB score ranges from 0 (worst performance) to 12 (best performance). The minimal clinically important difference is not fully agreed upon, although a difference of 1.0 point has been used in many studies.|Baseline and 6 weeks|||units on a scale||Standard Deviation|Mean
795247|NCT00914849|Secondary|Number of Donors Who Experience Grade 3-4 Mobilization Toxicity Due to Pheresis Procedure||Up to Day 2|||participants|||Number
795248|NCT00914849|Secondary|Rate of Chronic GVHD in Recipients||Day 101-1 year|8 patients are not evaluable because they were not alive for the outcome measure time frame.||participants|||Number
795249|NCT00914849|Secondary|Grade 3-4 Toxicity for Recipients|Assessed and graded according to NCI Common Terminology for Adverse Events Version 3.0.|1 year|||participants|||Number
795250|NCT00914849|Secondary|Transplant Related Mortality Rate for Recipients|Death that results from a transplant procedure related complication rather than from relapse of the underlying disease or unrelated cause.|Day 100|||participants|||Number
795251|NCT00914849|Secondary|Time to Platelet Engraftment for Recipients|Measured by determining the first of 3 consecutive measurements of platelet count = 20,000/ul without platelet transfusion support for 7 days.|Up to Day 100|||days||Full Range|Median
795252|NCT00914849|Secondary|Time to Neutrophil Engraftment for Recipients|Measured by determine the first 3 consecutive measurement of neutrophil count = 500/ul following conditioning regimen induced nadir.|Up through Day 100|||days||Full Range|Median
795253|NCT00914849|Secondary|Rate of Acute GVHD (Grade III-IV) in Recipients||Day 0-Day 100 (acute)|||participants|||Number
795254|NCT00914849|Secondary|Rate of Acute GVHD (Grade II-IV) in Recipients||Day 0-Day 100 (acute)|||participants|||Number
795255|NCT00914849|Secondary|Pharmacokinetics of IV AMD3100 as Measured by Mean Area Under Curve (AUC)||Day 1 and Day 2|||hr.ng/mL||Standard Deviation|Mean
795256|NCT00914849|Secondary|Pharmacokinetics of IV AMD3100 as Measured by Half Life|"-Blood samples for pharmacokinetics were drawn on the following schedule:
prior to IV infusion
15 minutes after start of infusion
30 minutes after start of infusion
1 hour after start of infusion
4 hours after start of infusion
6 hours after start of infusion
9 hours after start of infusion
24 hours after start of infusion"|Day 1 and Day 2|||hours||Standard Deviation|Mean
795257|NCT00914849|Secondary|Pharmacokinetics of IV AMD3100 as Measured by the Mean Maximum Plasma Concentration (Cmax)|"-Blood samples for pharmacokinetics were drawn on the following schedule:
prior to IV infusion
15 minutes after start of infusion
30 minutes after start of infusion
1 hour after start of infusion
4 hours after start of infusion
6 hours after start of infusion
9 hours after start of infusion
24 hours after start of infusion"|Day 1 and Day 2|||ng/mL||Standard Deviation|Mean
795258|NCT00914849|Secondary|Number of Recipients Who Have Neutrophil Engraftment||Day 21|||participants|||Number
795259|NCT00914849|Secondary|Number of Donors Who Experience Grade 3-4 Infusional Toxicity||Up to Day 2|||participants|||Number
795260|NCT00914849|Primary|Number of Donors Treated With IV AMD3100 Who Required a Second Collection to Obtain the Minimum CD34/kg (2 X 106) Necessary for Allogeneic Stem Cell Transplant||Completion of enrollment of all donors (17 months)|3 donors failed to reach target after two collections and 1 donor withdrew consent after failing to reach the goal on the first collection.||participants|||Number
795261|NCT00914862|Secondary|Number of Participants With Clinically Significant Physical Examination Results|A complete physical examination was performed for each participant at Screening, Check-in (Day 1), Day 2, and Final Visit (Day 4) or Early Termination. The examination consisted of a review of the following body systems: eyes; ears, nose, and throat; respiratory; gastrointestinal; extremities; musculoskeletal; cardiovascular; nervous; and dermatological.|Screening, Day 1, Day 2 and Day 4|Safety set.||participants|||Number
795262|NCT00914862|Secondary|Number of Participants With Clinically Significant Electrocardiogram Findings|A standard 12-lead electrocardiogram (ECG) was recorded at Screening, Day 2, and at Final Visit (Day 4). The investigator interpreted the ECG using one of the following categories: within normal limits, abnormal but not clinically significant, or abnormal and clinically significant.|Screening, Day 2 and Day 4|Safety set.||participants|||Number
795263|NCT00914862|Secondary|Number of Participants With Clinically Significant Vital Signs|Vital signs included oral body temperature, pulse and blood pressure (taken after 5 minutes in the sitting position). Vital signs measurements were determined to be clinically significant according to predefined criteria.|Screening, Day 1, Day 2 and Day 4|Safety set.||participants|||Number
795264|NCT00914862|Secondary|Number of Participants With Clinically Significant Laboratory Findings|Laboratory samples were collected at Screening, Check-in (Day 1), and Day 2 or Early Termination for assessment of hematology, chemistry, and urinalysis.|Screening, Day 1, Day 2 and Day 4|Safety set.||participants|||Number
795265|NCT00914862|Secondary|Number of Participants With Adverse Events (AE)|"An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it did not necessarily have to have a causal relationship with this treatment. The different categories of intensity (severity) were characterized as follows:
Mild: The event was transient and easily tolerated by the participant.
Moderate: The event causes the participant discomfort and interrupted usual activities.
Severe: The event causes considerable interference with the participant’s usual activities."|Day 1 to Day 15|The safety set includes all participants who received at least 1 dose of study drug.||participants|||Number
795352|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|3 months|||pg/ml||Standard Deviation|Mean
795267|NCT00914862|Primary|Terminal Elimination Half-life (T1/2)|Terminal phase elimination half-life (T1/2) for ramelteon and its metabolite M-II is the time required for half of the drug to be eliminated from the serum, calculated as T1/2 = natural logarithm of 2 (ln[2]) / Terminal elimination rate constant (λz).|Day 1: predose (within 1 hour prior to dose) and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 16 hours post-dose.|Pharmacokinetic set where valid PK parameter estimates were available.||hours||Standard Deviation|Mean
795268|NCT00914862|Primary|Terminal Elimination Rate Constant (λz)|The rate at which ramelteon and its metabolite M-II are eliminated from the body, calculated as the negative of the slope of the log-linear regression of the natural logarithm concentration-time curve during the terminal phase.|Day 1: predose (within 1 hour prior to dose) and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 16 hours post-dose.|Pharmacokinetic set where valid PK parameter estimates were available.||1/hour||Standard Deviation|Mean
795269|NCT00914862|Primary|Apparent Clearance After Oral Administration (CL/F)|"Apparent oral clearance of drug from the serum calculated as:
CL/F = Dose / Area under the serum concentration-time curve from time 0 extrapolated to infinity (AUC[0-inf])."|Day 1: predose (within 1 hour prior to dose) and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 16 hours post-dose.|Pharmacokinetic set where valid PK parameter estimates were available.||L/hr||Standard Deviation|Mean
795270|NCT00914862|Primary|Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUC[0-inf])|Area under the serum concentration-time curve from time zero extrapolated to infinity for ramelteon and its metabolite M-II. The terminal area from the last quantifiable concentration (lqc) to infinity is calculated by approximation: lqc / terminal elimination rate constant (λz).|Day 1: predose (within 1 hour prior to dose) and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 16 hours post-dose.|Pharmacokinetic set where valid PK parameter estimates were available.||ng*hr/mL||Standard Deviation|Mean
795271|NCT00914862|Primary|Area Under the Serum Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc])|Area under the serum concentration-time curve from time 0 to time of last quantifiable concentration (tlqc) of ramelteon and its metabolite M-II, calculated using the linear trapezoidal rule.|Day 1: predose (within 1 hour prior to dose) and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 16 hours post-dose.|Pharmacokinetic set where valid PK parameter estimates were available.||ng*hr/mL||Standard Deviation|Mean
795272|NCT00914862|Primary|Time to Reach Maximum Serum Concentration (Tmax)|Tmax: Time to reach the maximum serum concentration (Cmax) of ramelteon and its metabolite M-II, equal to time (hours) to Cmax.|Day 1: predose (within 1 hour prior to dose) and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 16 hours post-dose.|Pharmacokinetic set where valid PK parameter estimates were available.||hours||Full Range|Median
795273|NCT00914862|Primary|Maximum Observed Serum Concentration (Cmax)|Maximum observed serum concentration (Cmax) is the peak serum concentration of ramelteon and its metabolite (M-II) after administration, obtained directly from the serum concentration-time curve.|Day 1: predose (within 1 hour prior to dose) and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 16 hours post-dose.|The Pharmacokinetic (PK) set, which consisted of all patients who received study drug and had sufficient concentration data to calculate at least 1 PK parameter.||ng/mL||Standard Deviation|Mean
795274|NCT00914966|Secondary|Use of Rescue Therapy and/or Other Therapy for Treatment of HAE Symptoms||12 weeks at each dose level||||||
795275|NCT00914966|Secondary|Treatment Effect of Escalating Doses of CINRYZE on HAE Attack Rates|"Two definitions of success were applied in this study:
Per-protocol success - Average angioedema attack rate of ≤1.0 per month at the end of any dose escalation step (Week 12). The a priori definition of study success was 4 or more subjects with per-protocol success.
Investigator-determined success - Based on the investigator's clinical judgment, an average monthly angioedema attack rate demonstrating improvement sufficient for progression to follow-up.
In addition, subjects who were not a per-protocol or investigator-determined success, but who experienced a reduction of >1.0 attack per month from their historical angioedema attack rate at the end of any dose escalation step (Week 12), were summarized."|12 weeks at each dose level|||participants|||Number
795276|NCT00914966|Primary|Number of Subjects With Adverse Events, Hospitalizations, Thrombotic Events, Treatment-emergent C1 INH Antibodies, Post-baseline Toxicity Grade Increases in Clinical Laboratory Parameters, and Post-dose Vital Signs Changes of Potential Clinical Importance|Events reported during the 3 month follow-up period are counted with the dose level at which they occurred.|12 to 24 weeks at each dose level|||participants|||Number
795277|NCT00922935|Primary|Bone Level Change on Radiographs|Crestal bone level change at implant margin.The difference between baseline and 3 years after loading.|3 years after loading|||mm||Standard Deviation|Mean
795278|NCT00922987|Other Pre-specified|Number of Participants With Concomitant Co-morbidities|Participants who had a concomitant co-morbidity during the study for any period of time from baseline through to Week 16 (Final Visit); participants with more than one concomitant co-morbidity were counted for each of the co-morbidity classes applicable.|Baseline through week 16 or ET|Safety analysis set included all enrolled participants who received 1 dose of study medication.||participants|||Number
795279|NCT00922987|Other Pre-specified|Number of Participants With Concomitant Drug Treatments|Concomitant drug (any drug other than, and in addition to, the study drug) taken for any period of time during the study.|Baseline through Week 16 or ET|Safety analysis set included all enrolled participants who received 1 dose of study medication.||participants|||Number
795280|NCT00922987|Secondary|Change From Baseline in Medical Outcome Study (MOS) Sleep Scale Sub-scores at Week 16 or ET|MOS: participant rated questionnaire, assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Transformed scores (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); sub-scales total score range= 0-100; higher score indicates greater intensity of attribute.|Baseline and week 16 or ET|The FAS included all participants who received at least 1 dose of the study drug and had at least one efficacy measurement.||Units on a scale||Standard Deviation|Mean
795294|NCT00923091|Secondary|Number of Subjects Reaching Blood Pressure Goal at Week 10|Blood pressure treatment goal was defined as blood pressure <140/90 mmHg or <130/80 mmHg for subjects with diabetes, chronic renal disease, or chronic cardiovascular disease.|baseline to week 10|The full analysis set includes 2679 randomized patients who received at least 1 dose of double-blind medication and who provided at least one diastolic blood pressure measurement in Period I-II||Participants|||Number
811163|NCT01061008|Secondary|Handgrip Endurance||3 months||||||
795281|NCT00922987|Secondary|Number of Participants With Change in Clinical Global Impression of Severity (CGI-C) From Baseline at Final Visit|"The CGI-C scale measures a physician’s global impression of a participant’s clinical condition at final visit in terms of change relative to the start of treatment (CGI-C).
At final visit, the participants CGI-C will be categorized into a three point scale as: improvement: CGI response of very much improved, much improved or minimally improved; no change: CGI response of no change; worsening: CGI response of very much worse, much worse or minimally worse."|Week 16 or ET|FAS: Included all participants who received at least 1 dose of study drug. Participants who did not have the minimum required data for the statistical summary were treated as missing.||Participants|||Number
795282|NCT00922987|Secondary|Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected.|Baseline|FAS: Included all participants who received at least 1 dose of study drug. Participants who did not have the minimum required data for the statistical summary were treated as missing.||participants|||Number
795283|NCT00922987|Secondary|Change From Baseline in Visual Analog Scale of Anxiety (VAS-A) Scores at Week 4 and Final Visit|VAS-A consists of a visual analog scale ranging from, 0 mm (no anxiety) to 100 mm (extreme anxiety).|Baseline, week 4 and week 16 or ET|Full Analysis Set (FAS): Included all participants who received at least 1 dose of study drug. Participants who did not have the minimum required data for the statistical summary were treated as missing. Analysis was done using LOCF method.||millimeter (mm)||95% Confidence Interval|Mean
795284|NCT00922987|Secondary|Number of Participants With no Seizures (Partial or Other) During the Last 4 Weeks in the Study|Participants were regarded as seizure-free if no seizures (partial or other) were reported for the participant during the last 4 weeks in the study.|Week 4 through week 16 or ET|MFAS: Data collected during the titration phase, i.e. prior to Visit 2 (Week 4) were not analyzed for this endpoint. Only participants who did not discontinue in the first 4 weeks after the baseline visit (titration phase) and had at least 4 weeks of seizure data during the maintenance phase were analyzed for this endpoint.||Participants|||Number
795285|NCT00922987|Secondary|Percentage Change From Baseline in 28 Day Partial Seizure Frequency at Final Visit|The partial seizure frequency for the baseline period was the total number of partial seizures recorded for that period at Visit 0 (week 0). For each participant’s final visit, the 28 day partial seizure frequency equals total number of partial seizures since the last visit * 28 divided by total number of days since the last visit. For percent change from baseline: change from baseline in partial seizure frequency*100 divided by partial seizure frequency at baseline visit.|Baseline and week 16 or ET|MFAS included all participants who received at least 1 dose of the study drug and who had at least one baseline seizure. Participants who discontinued during first 4 weeks titration phase were regarded as missing and were excluded from the analysis. Analysis was done using last observation carried forward (LOCF) method.||percent change||95% Confidence Interval|Median
795286|NCT00922987|Primary|Percentage of Participants With a 50 Percent or Greater Reduction From Baseline in 28 Day Partial Seizure Frequency|Responder rate was defined as the percentage of participants with at least a 50% reduction in 28-day partial seizure frequency from baseline during the maintenance phase (Week 4 – Week 16). The percent change in partial seizure frequency in the maintenance phase was the change from baseline in partial seizure frequency * 100, divided by the partial seizure frequency at the baseline visit.|Baseline through week 16 or early termination (ET)|The modified full analysis set (MFAS) included all participants who received at least 1 dose of the study drug and who had at least one baseline seizure. Participants who discontinued during first 4 weeks titration phase were regarded as missing and were excluded from the analysis.||Percentage of participants||95% Confidence Interval|Number
795287|NCT00923091|Secondary|Change in Seated Systolic Blood Pressure (SeDBP) During Open-Label Period VI (Titration Effect From OM/AML/HCTZ 40/5/25 to 40/10/25.||Week 26 to week 54|The number of subjects up titrated who had blood pressure values at both time points.||mm Hg||Standard Deviation|Mean
795288|NCT00923091|Secondary|Number of Subjects Reaching Blood Pressure Goal at Week 26|Blood pressure treatment goal was defined as blood pressure <140/90 mmHg or <130/80 mmHg for subjects with diabetes, chronic renal disease, or chronic cardiovascular disease.|Week 22 to week 26|The Full Analysis Set 3=312 randomized participants who received at least one dose of double-blind medication and who provided at least one diastolic blood pressure measurement in Period V||Participants|||Number
795289|NCT00923091|Secondary|Change in Seated Systolic Blood Pressure From Week 22 to Week 26||Week 22 to week 26|The Full Analysis Set 3=312 randomized participants who received at least one dose of double-blind medication and who provided at least one diastolic blood pressure measurement in Period V.||mm Hg||Standard Error|Least Squares Mean
795290|NCT00923091|Secondary|Change in Seated Diastolic Blood Pressure From Week 22 to Week 26||Week 22 to week 26|The Full Analysis Set 3=312 randomized participants who received at least one dose of double-blind medication and who provided at least one diastolic blood pressure measurement in Period V.||mm Hg||Standard Error|Least Squares Mean
795291|NCT00923091|Secondary|Number of Subjects Reaching Blood Pressure Goal From Week 18 to Week 22|Blood pressure treatment goal was defined as blood pressure <140/90 mmHg or <130/80 mmHg for subjects with diabetes, chronic renal disease, or chronic cardiovascular disease.|Week 18 to week 22|The Full Analysis Set 2=681 randomized participants who received at least 1 dose of double-blind medication and who provided at least one diastolic blood pressure measurement in Period IV||Participants|||Number
795292|NCT00923091|Secondary|Change in Seated Systolic Blood Pressure From Week 18 to Week 22||Week 18 to week 22|The Full Analysis Set 2=681 randomized participants who received at least 1 dose of double-blind medication and who provided at least one blood pressure measurement in Period IV||mm Hg||Standard Error|Least Squares Mean
795293|NCT00923091|Secondary|Change in Seated Diastolic Blood Pressure From Week 18 to Week 22||Week 18 to week 22|The Full Analysis Set 2=681 randomized participants who received at least 1 dose of double-blind medication and who provided at least one diastolic blood pressure measurement in Period IV||mm Hg||Standard Error|Least Squares Mean
795295|NCT00923091|Secondary|Change in Seated Systolic Blood Pressure (SeDBP).||Baseline to week 10|The full analysis set includes 2679 randomized patients who received at least 1 dose of double-blind medication and who provided at least one diastolic blood pressure measurement in Period I-II||mm Hg||Standard Error|Least Squares Mean
811071|NCT01051778|Secondary|Preeclampsia||Pregnancy > 20 weeks gestation||||||
795296|NCT00923091|Primary|Change in Seated Diastolic Blood Pressure (SeDBP).|Baseline blood pressure was defined as the average values obtained at the randomization visit and at the visit prior to randomization|Baseline to week 10|The full analysis set includes 2679 randomized patients who received at least 1 dose of double-blind medication and who provided at least one diastolic blood pressure measurement in Period I-II||mm HG||Standard Error|Least Squares Mean
795297|NCT00923117|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|7/2/08 -12/6/13|||Participants|||Number
795298|NCT00923117|Primary|6-month Progression-free Survival.|Time between the start of treatment to progression. Progression is defined by the RANO(Response Assessment in Neuro-Oncology) criteria. Progression is defined by any of the following: 25% increase in sum of the products of perpendicular diameters of enhancing lesions; any new lesion; or clinical deterioration.|6 months|63 patients enrolled with glioblastoma multiforme (GBM) (32 Bev naive, 31 Bev resistant) and were evaluated for this outcome measure.||Months||95% Confidence Interval|Median
795299|NCT00923130|Other Pre-specified|Regression Rate Constant (d)|This assessment was intended as an exploratory analysis.|up to 50 days|This outcome measure was not done. Data was not collected because the clinical data did not support further analysis and interest.|||||
795300|NCT00923130|Other Pre-specified|Percentage of Participants With an Increase or Decrease in Reverse Contrast Transfer Rate (Kep) Using MRI Versus Conventional Imaging|This assessment was intended as an exploratory analysis.|Cycle 1 before day 1 of treatment and day 5 following infusion|This outcome measure was not done. Data was not collected because the clinical data did not support further analysis and interest.|||||
795301|NCT00923130|Other Pre-specified|Percentage of Participants With an Increase or Decrease in Forward Contrast Transfer Rate (Ktrans) Using MRI Versus Conventional Imaging|This assessment was intended as an exploratory analysis.|Cycle 1 before day 1 of treatment and day 5 following infusion|This outcome measure was not done. Data was not collected because the clinical data did not support further analysis and interest.|||||
795302|NCT00923130|Other Pre-specified|Growth Rate Constant (g)|This assessment was intended as an exploratory analysis.|up to 50 days|This outcome measure was not done. Data was not collected because the clinical data did not support further analysis and interest.|||||
795303|NCT00923130|Other Pre-specified|Tumor Endothelial Markers (TEMs)|This assessment was intended as an exploratory analysis.|Cycle 1 Day 5, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 6 Day 1|This outcome measure was not done. Data was not collected because the clinical data did not support further analysis and interest.|||||
795304|NCT00923130|Other Pre-specified|Micro Vessel Density|This assessment was intended as an exploratory analysis|Prior to cycle 2|This outcome measure was not done. Data was not collected because the clinical data did not support further analysis and interest.|||||
795305|NCT00923130|Other Pre-specified|Circulating Endothelial Cells (CECs)|This assessment was intended as an exploratory analysis.|Baseline, Day 5, and Cycle 2 Day 1|This outcome measure was not done. Data was not collected because the clinical data did not support further analysis and interest.|||||
795306|NCT00923130|Other Pre-specified|Protein Profiling of Vascular Endothelial Growth Factor A (VEGF-A), Vascular Endothelial Growth Factor Receptor 2 (VEGFR-2), Vascular Endothelial Growth Factor Receptor 3 (VEGFR-3), Beta Fibroblast Growth Factor (βFGF) and Erythropoietin From Baseline|This assessment was intended as an exploratory analysis.|Cycle 1 Day 5 (C1D5), Cycle 2 Day 1 (C2D1), Cycle 4 and Cycle 6|This outcome measure was not done. Data was not collected because the clinical data did not support further analysis and interest.|||||
795307|NCT00923130|Secondary|Overall Survival|Time between the first day of treatment and the day of death.|Time between the first day of treatment and the day of death, assessed up to approximately 7 years.|||months||95% Confidence Interval|Median
795308|NCT00923130|Secondary|Number of Participants Who Had Biopsies|To obtain tumor tissue and perform analysis for molecular changes in the tumor before and after a cycle of chemotherapy.|Baseline and Cycle 2 Day 1|This outcome measure was not done because biopsy samples were not obtained.|||||
795309|NCT00923130|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events, see the adverse event module. Adverse events are assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0.|84 months and 25 days|||participants|||Number
795310|NCT00923130|Secondary|Number of Participants With an Objective Response (Complete Response (CR) or Partial Response (PR)) Per the Response Evaluation Criteria in Solid Tumors (RECIST)|Response (complete response (CR) and partial response (PR)) was measured by the RECIST. Complete response is the disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.|Two Years|||participants|||Number
795311|NCT00923130|Primary|Progression-free Survival|The time between the first day of treatment to the day of disease progression. Progression is defined by the Response Evaluation Criteria in Solid Tumors (RECIST). Progression is at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|up to 44 months|||months||95% Confidence Interval|Median
795312|NCT00923156|Secondary|Pharmacokinetic of Aliskiren: The Terminal Elimination Half-life (T½)|Blood samples (2 mL) for the determination of aliskiren concentration in plasma were collected using an indwelling cannula inserted in a forearm vein. Samples were collected at week 12 (day 84): pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post-dose.|12 weeks|All subjects with evaluable PK parameter data and no major protocol deviations with impact on PK data were included in the PK data analysis.||hour||Standard Deviation|Mean
795313|NCT00923156|Secondary|Pharmacokinetic of Aliskiren: The Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf)|Blood samples (2 mL) for the determination of aliskiren concentration in plasma were collected using an indwelling cannula inserted in a forearm vein. Samples were collected at week 12 (day 84): pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post-dose.|12 weeks|All subjects with evaluable PK parameter data and no major protocol deviations with impact on PK data were included in the PK data analysis.||hr*ng/mL||Standard Deviation|Mean
795353|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|Basal|||pg/ml||Standard Deviation|Mean
811164|NCT01061008|Secondary|Maximum Handgrip Strength||3 months||||||
795314|NCT00923156|Secondary|Pharmacokinetic of Aliskiren: The Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast)|Blood samples (2 mL) for the determination of aliskiren concentration in plasma were collected using an indwelling cannula inserted in a forearm vein. Samples were collected at week 12 (day 84): pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post-dose.|12 weeks|All subjects with evaluable PK parameter data and no major protocol deviations with impact on PK data were included in the PK data analysis.||hr*ng/mL||Standard Deviation|Mean
795315|NCT00923156|Secondary|Pharmacokinetic of Aliskiren: The Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau(AUCtau)|Blood samples (2 mL) for the determination of aliskiren concentration in plasma were collected using an indwelling cannula inserted in a forearm vein. Samples were collected at week 12 (day 84): pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post-dose.|12 weeks|All subjects with evaluable PK parameter data and no major protocol deviations with impact on PK data were included in the PK data analysis.||hr*ng/mL||Standard Deviation|Mean
795316|NCT00923156|Secondary|Pharmacokinetic of Aliskiren: The Observed Maximum Plasma Concentration (Cmax) Following Drug Administration|Blood samples (2 mL) for the determination of aliskiren concentration in plasma were collected using an indwelling cannula inserted in a forearm vein. Samples were collected at week 12 (day 84): pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post-dose.|12 weeks|All subjects with evaluable PK parameter data and no major protocol deviations with impact on PK data were included in the PK data analysis.||ng/mL||Standard Deviation|Mean
795317|NCT00923156|Secondary|Pharmacokinetic of Aliskiren: Time to Reach the Maximum Concentration (Tmax) After Drug Administration|Blood samples (2 mL) for the determination of aliskiren concentration in plasma were collected using an indwelling cannula inserted in a forearm vein. Samples were collected at week 12 (day 84): pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post-dose.|12 weeks|All subjects with evaluable PK parameter data and no major protocol deviations with impact on PK data were included in the PK data analysis.||Hour||Full Range|Median
795318|NCT00923156|Secondary|Biomarker Urinary Aldosterone After 12 Weeks of Treatment|24 hour urine collections were performed. Geometric Mean Ratio to baseline at Week 12 for Urinary aldosterone was calculated 24 hours post-dose.|Baseline,12 weeks (Day 84 period 2)|Pharmacodynamic (PD) Analysis Set: Subjects with any available PD data and no major protocol deviations with impact on PD data. Only patients with a value at both baseline and post-dose are included.||ratio||95% Confidence Interval|Geometric Mean
795319|NCT00923156|Secondary|Biomarker B-type Natriuretic Peptide (BNP) After 12 Weeks of Treatment|Peripheral venous blood was collected after 30 minutes of rest in the sitting position for analysis of biomarkers. Geometric Mean Ratio to baseline at Week 12 for BNP was calculated at 0 hours pre-dose.|Baseline, 12 weeks (Day 84 period 2)|Pharmacodynamic (PD) Analysis Set: Subjects with any available PD data and no major protocol deviations with impact on PD data. Only patients with a value at both baseline and post-dose are included.||ratio||95% Confidence Interval|Geometric Mean
795320|NCT00923156|Secondary|Biomarker Trapping Plasma Renin Activity (tPRA) After 12 Weeks of Treatment|Peripheral venous blood was collected after 30 minutes of rest in the sitting position for analysis of biomarkers. Geometric Mean Ratio to baseline at Week 12 for tPRA was calculated at 0 hour pre-dose, 3 hour and 24 hour post-dose.|Baseline,12 weeks (84 days, Period 2)|"Pharmacodynamic (PD) Analysis Set: Subjects with any available PD data and no major protocol deviations with impact on PD data. Only patients with a value at both baseline and post-dose are included. In each category n indicates patients with observations at that time point."||ratio||95% Confidence Interval|Geometric Mean
795321|NCT00923156|Secondary|Biomarker Plasma Renin Concentration (PRC)After 12 Weeks of Treatment|Peripheral venous blood was collected after 30 minutes of rest in the sitting position for analysis of biomarkers. Geometric Mean Ratio to baseline at 12 weeks for PRC was calculated at 0 hour pre-dose.|Baseline, 12 weeks (84 days, period 2)|Pharmacodynamic (PD) Analysis Set: Subjects with any available PD data and no major protocol deviations with impact on PD data. Only patients with a value at both baseline and post-dose are included.||ratio||95% Confidence Interval|Geometric Mean
795322|NCT00923156|Primary|Venous Angiotensin II Levels After 12 Weeks of Treatment|Peripheral venous blood was collected after 30 minutes of rest in the sitting position for analysis of biomarkers. Geometric mean ratio to baseline at Week 12 for Venous angiotensin II levels was calculated in patients with decompensated systolic heart failure (SHF) and left ventricular ejection fraction ≤40% at 0 hour pre-dose, 3 hours and 24 hours post-dose.|Baseline. 12 Weeks (Day 84, period 2)|"Pharmacodynamic (PD) Analysis Set: Subjects with any available PD data and no major protocol deviations with impact on PD data. Only patients with a value at both baseline and post-dose are included. In each category n indicates patients with observations at that time point."||ratio||95% Confidence Interval|Geometric Mean
795323|NCT00923195|Secondary|Toxicity Profile|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|32 months|||Participants|||Number
795324|NCT00923195|Primary|Complete Response Rates for Patients With Metastatic Melanoma|Complete response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete response is a disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progression is at least a 20% increase in the sum of the LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum LD.|Every 4-6 weeks after initial treatment regimen. If the patient has stable disease or tumor shrinkage, complete evaluations will be repeated every 1-3 months.|||Participants|||Number
795325|NCT00923247|Secondary|Comparison of Steady State Vandetanib Exposure With Relevant Literature Values|"Because vandetanib PK exposure was only measured during a single 8-hr window during daily dosing, the only comparison to assess the effect of bortezomib is to compare these values to published literature."|Cycle 3 day 1 (an average of 60 days); and Pre-dose and 1, 2, 4, 6, 8, 10, and 24 hours post dose|Vandetanib PK samples were only obtained during the phase 1 portion of the study during cycle 3, day 1, where patients received both vandetanib (at steady-state) and bortezomib. “13/14 patients analyzed on day 61 (C3D1). Those patients that were not analyzed had insufficient PK data to calculate this parameter.”||ng/mL/mg||Standard Deviation|Mean
796518|NCT00929734|Secondary|Relative Change in Interleukin 6||Baseline to 3 months|Complete case analysis||percent change||Inter-Quartile Range|Median
795326|NCT00923247|Secondary|Bortezomib Volume of Distribution (Vss)|Vss represents the volume into which the drug distributes into once given to the patient at steady-state. This volume parameter provides a measure of where in the body the drug is going, based on fluid volume.|Cycle 1 day 1, and cycle 3 day 1 (an average of 61 days); and Pre-dose and 1, 2, 4, 6, 8, 10, and 24 hours post dose|“7/14 patients were analyzed on day 1; 13/14 patients analyzed on day 61. Those patients that were not analyzed had insufficient PK data to calculate this parameter.”||Liter||95% Confidence Interval|Geometric Mean
795327|NCT00923247|Secondary|Total Systemic Clearance (CL) of Bortezomib|Total systemic clearance = dose/area under curve extrapolated to infinity (AUCinf.). This measurement represents the rate at which plasma is systematically cleared of drug.|Cycle 1 day 1, and cycle 3 day 1 (an average of 61 days); and Pre-dose and 1, 2, 4, 6, 8, 10, and 24 hours post dose|“7/14 patients were analyzed on day 1; 13/14 patients analyzed on day 61. Those patients that were not analyzed had insufficient PK data to calculate this parameter.”||L/hr||95% Confidence Interval|Geometric Mean
795328|NCT00923247|Secondary|Terminal Half-Life (T1/2) of Bortezomib|The time it takes for the measured concentration of the drug to drop by half.|Cycle 1 day 1, and cycle 3 day 1 (an average of 61 days); and Pre-dose and 1, 2, 4, 6, 8, 10, and 24 hours post dose|“7/14 patients were analyzed on day 1; 13/14 patients analyzed on day 61. Those patients that were not analyzed had insufficient PK data to calculate this parameter.”||hour||95% Confidence Interval|Geometric Mean
795329|NCT00923247|Secondary|Area Under the Bortezomib Plasma Concentration Versus Time Curve From Time Zero to Infinity/Dose (AUCinf/D)|The area under the concentration-time curve (AUC) extrapolated to infinity (AUCinf) was calculated using the linear up-log down trapezoidal method via extrapolation of AUC(LAST) (AUC to the last quantifiable time point) by dividing C(LAST) (the last measurable drug concentration, typically at 24 hour post-dose) by the rate constant of the terminal phase, lambda z. This constant was determined from the slope of the terminal phase of the concentration-time curve using weighted least-squares as the estimation procedure.|Cycle 1 day 1, and cycle 3 day 1 (an average of 61 days); and Pre-dose and 1, 2, 4, 6, 8, 10, and 24 hours post dose|PK samples were only done during the phase I portion of the study. “7/14 patients were analyzed on day 1; 13/14 patients analyzed on day 61. Those patients that were not analyzed had insufficient PK data to calculate this parameter.” Please see other outcome measure modules for details.||hr*ng/mL/mg||95% Confidence Interval|Geometric Mean
795330|NCT00923247|Secondary|Maximum Bortezomib Plasma Concentration Normalized to Dose (Cmax/D)|Geometric mean for Bortezomib pharmacokinetic (PK) parameters both before (cycle 1 day 1) and during steady-state Vandetanib (cycle 3 day 1; exposures are dose normalized). Bortezomib plasma concentrations were measured using a validated LC-MS/MS assay with a lower limit of quantification (LLOQ) of 1 ng/mL. Only measured concentrations above the LLOQ were used in the calculation of PK parameters. The maximum plasma concentration (Cmax) was recorded as observed values.|Cycle 1 day 1, and cycle 3 day 1 (an average of 61 days); and Pre-dose, 1, 2,4, 6, 8, 10 and 24 hours post dose|“7/14 patients were analyzed on day 1; 13/14 patients analyzed on day 61. Those patients that were not analyzed had insufficient PK data to calculate this parameter.”||ng/mL/mg||95% Confidence Interval|Geometric Mean
795331|NCT00923247|Secondary|Percentage of Participants With a Change in Consistency in Tumor-Related Diarrhea Compared to Baseline|Baseline stool consistency (formed, loose or partially formed, watery) will be the consistency most frequently observed during a 7-day period immediately prior to starting vandetanib. Complete response (CR) is an average of 0-2 formed stools per day for a period of at least 4 weeks. Partial response (PR) is a ≥50% decrease in the average stool frequency relative to baseline and a change in stool consistency from watery to loose (partially formed) for a period of at least 4 weeks. No response is criteria for CR or PR not met. Only patients with a stool frequency of ≥5/day and a stool consistency of watery will be evaluable for clinical response.|Baseline, and for a period of at least 4 weeks post study drug administration|This outcome measure was not analyzed because the number of patients eligible for this response is 0, in both the Phase I and Phase II cohorts. None of the participants met the criteria of >=5 watery stools per day at baseline. No participants were enrolled in the phase IIB cohort.|||||
795332|NCT00923247|Secondary|Percentage of Participants With a Change in Frequency in Tumor-Related Diarrhea Compared to Baseline|Complete response is an average of 0-2 formed stools per day for a period of at least 4 weeks. partial response is a ≥50% decrease in the average stool frequency relative to baseline and a change in stool consistency from watery to loose (partially formed) for a period of at least 4 weeks. No response is criteria for CR or PR not met. Only patients with a stool frequency of ≥5/day and a stool consistency of watery will be evaluable for clinical response.|Baseline, and for a period of at least 4 weeks post study drug administration|This outcome measure was not analyzed because no participant had a baseline diarrhea that met the criteria for analysis. They needed to have diarrhea 5 times a day for several days in a row and no one had the baseline problem.|||||
795333|NCT00923247|Secondary|Number of Participants With Tumor Biomarker Carcinoembryonic Antigen (CEA) Response|Carcinoembryonic Antigen (CEA) was measured by the biomarker response criteria. Complete response (CR) is normalization (≤ upper limit of normal) of CEA level following treatment, confirmed with a repeat CEA level at least 4 weeks apart. Partial response (PR) is a ≥50% decrease in the CEA level relative to the baseline level, confirmed with a repeat CEA level at least 4 weeks apart. Progressive disease is a ≥50% increase in the CEA relative to the baseline level, confirmed with a repeat CEA level at least 4 weeks apart. Stable disease is <50% increase or decrease in CEA level relative to the baseline level.|4 weeks|No participants were enrolled in the phase IIB cohort. Only participants with average pre-treatment CEA levels that are >2 times the upper limit of normal are evaluable for biomarker response. There were 14 participants that met this criteria.||Participants|||Count of Participants
795334|NCT00923247|Secondary|Number of Participants With Tumor Biomarker Calcitonin (CTN) Response|Calcitonin was measured by the biomarker response criteria. Complete response (CR) is normalization (≤ upper limit of normal) of CTN level following treatment, confirmed with a repeat CTN level at least 4 weeks apart. Partial response (PR) is a ≥50% decrease in the CTN level relative to the baseline level, confirmed with a repeat CTN level at least 4 weeks apart. Progressive disease is a ≥50% increase in the CTN relative to the baseline level, confirmed with a repeat CTN level at least 4 weeks apart. Stable disease is <50% increase or decrease in CTN level relative to the baseline level.|4 weeks|No participants were enrolled in the phase IIB cohort. Only participants with average pre-treatment CTN levels that are >2 times the upper limit of normal are evaluable for biomarker response. There were 16 participants that met this criteria.||Participants|||Count of Participants
795336|NCT00923247|Secondary|Progression Free Survival (PFS)|Progression free survival is defined as the duration of time from start of treatment to time of progression. Comparison of PFS between cohorts 1, 2A and 2B was to be assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Progressive disease is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|2-3 years|A comparison between phase 1, 2A and 2B was not done because no participants were enrolled in the phase 2B cohort.||Months||Full Range|Median
795337|NCT00923247|Secondary|Response Rate (Complete Response (CR) + Partial Response (PR) of Adults With a Diagnosis of MTC Treated With Either of Two Regimens: (1) Daily Oral Vandetanib and Bortezomib or (2) Daily Oral Vandetanib|Comparison of response between cohorts 1, 2A and 2B was to be determined by computed tomography scan reviews using the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|2-3 years|A comparison between phase 1, 2A and 2B was not done because no participants were enrolled in the phase 2B cohort.||Participants|||Count of Participants
795338|NCT00923247|Primary|Phase 2: Progression Free Survival in Adults With a Diagnosis of Medullary Thyroid Cancer (MTC) Treated With Daily Oral Vandetanib and Bortezomib|"Progression free survival is defined as the duration of time from start of treatment to time of progression. Progression is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) and is defined as the appearance of one or more new lesions or unequivocal progression of existing non-target lesions. Although a clear progression of non-target lesions only is exceptional, the opinion of the treating physician should prevail in such circumstances, and the progression status should be confirmed at a later time by the review panel (or Principal Investigator)."|4 months|No participants were enrolled in the phase IIB cohort. One participant was in cohort 2A, thus standard deviation could not be calculated.||months||Standard Deviation|Median
795339|NCT00923247|Primary|Phase 2: Tumor Response in Adults With a Diagnosis of Medullary Thyroid Cancer (MTC) Treated With Daily Oral Vandetanib and Bortezomib|Response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|4 months|No participants were enrolled in the phase IIB cohort.||Participants|||Count of Participants
795340|NCT00923247|Primary|Phase I: Maximum Tolerated Dose (MTD) of Daily Oral Bortezomib|A maximum tolerated dose for bortezomib will be determined if dose limiting toxicity is observed in 2 or more patients at one of the dose levels being evaluated. The MTD will be the dose level immediately preceding the dose level at which DLT (e.g. defined as neutrophil count below 1000/ µL (grade 3) on 2 consecutive measurements drawn at least 72 hours OR a single neutrophil count below 500/µL occurred. Platelet count below 50,000 µL (grade 3) on 2 consecutive measurements drawn at least 72 hours apart OR a singe platelet count below 25,000/µL. A platelet transfusion administered when platelet count is below 50,000/µL is dose limiting thrombocytopenia, unless the transfusion is being administered for peri-operative coverage.|80 days|||mg/m^2|||Number
795341|NCT00923247|Primary|Phase I: Maximum Tolerated Dose (MTD) of Daily Oral Vandetanib|A maximum tolerated dose for vandetanib will be determined if dose limiting toxicity is observed in 2 or more patients at one of the dose levels being evaluated. The MTD will be the dose level immediately preceding the dose level at which DLT (e.g. defined as neutrophil count below 1000/ µL (grade 3) on 2 consecutive measurements drawn at least 72 hours OR a single neutrophil count below 500/µL occurred. Platelet count below 50,000 µL (grade 3) on 2 consecutive measurements drawn at least 72 hours apart OR a singe platelet count below 25,000/µL. A platelet transfusion administered when platelet count is below 50,000/µL is dose limiting thrombocytopenia, unless the transfusion is being administered for peri-operative coverage.|80 days|||mg|||Number
795342|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (Adiponectin)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 year|||ng/ml||Standard Deviation|Mean
795343|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (Adiponectin)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|6 months|||ng/ml||Standard Deviation|Mean
795344|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (Adiponectin)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|3 months|||ng/ml||Standard Deviation|Mean
795345|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (Adiponectin)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|Basal|||ng/ml||Standard Deviation|Mean
795346|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (Leptin)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 year|||ng/ml||Standard Deviation|Mean
795347|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (Leptin)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|6 months|||ng/ml||Standard Deviation|Mean
795348|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (Leptin)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|3 months|||ng/ml||Standard Error|Mean
795349|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (Leptin)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|Basal|||ng/ml||Standard Deviation|Mean
795350|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 year|||pg/ml||Standard Deviation|Mean
795351|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement|6 months|||pg/ml||Standard Deviation|Mean
811072|NCT01051778|Secondary|Thrombocytopenia||Duration of pregnancy and puerperium||||||
795354|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement|1 year|||μg/mL||Standard Deviation|Mean
795355|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|6 months|||μg/mL||Standard Deviation|Mean
795356|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|3 months|||μg/mL||Standard Deviation|Mean
795357|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement|Basal|||μg/mL||Standard Deviation|Mean
795358|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (Interleukine-6)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 year|||pg/ml||Standard Deviation|Mean
795359|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (Interleukine-6)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|6 months|||pg/ml||Standard Deviation|Mean
795360|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (Interleukine-6)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|3 months|||pg/ml||Standard Deviation|Mean
795361|NCT00923260|Primary|Components of Metabolic Syndrome (High-Density Lipoproteins)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 year|||mg/dl||Standard Deviation|Mean
795362|NCT00923260|Primary|Components of Metabolic Syndrome (High-Density Lipoproteins)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|6 months|||mg/dl||Standard Deviation|Mean
795363|NCT00923260|Primary|Components of Metabolic Syndrome (High-Density Lipoproteins)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|3 months|||mg/dl||Standard Deviation|Mean
795364|NCT00923260|Primary|Components of Metabolic Syndrome (High-Density Lipoproteins)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 month|||mg/dl||Standard Deviation|Mean
795365|NCT00923260|Primary|Components of Metabolic Syndrome (High-Density Lipoproteins)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|Basal|||mg/dl||Standard Deviation|Mean
795366|NCT00923260|Primary|Components of Metabolic Syndrome (Low-Density Lipoproteins)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 year|||mg/dl||Standard Deviation|Mean
795367|NCT00923260|Primary|Components of Metabolic Syndrome (Low-Density Lipoproteins)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|6 months|||mg/dl||Standard Deviation|Mean
795368|NCT00923260|Primary|Components of Metabolic Syndrome (Low-Density Lipoproteins)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|3 months|||mg/dl||Standard Deviation|Mean
795369|NCT00923260|Primary|Components of Metabolic Syndrome (Low-Density Lipoproteins)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 month|||mg/dl||Standard Deviation|Mean
795370|NCT00923260|Primary|Components of Metabolic Syndrome (Low-Density Lipoproteins)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|Basal|||mg/dl||Standard Deviation|Mean
795371|NCT00923260|Primary|Components of Metabolic Syndrome (Triglycerides)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 year|||mg/dl||Standard Deviation|Mean
795372|NCT00923260|Primary|Components of Metabolic Syndrome (Triglycerides)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|6 months|||mg/dl||Standard Deviation|Mean
795373|NCT00923260|Primary|Components of Metabolic Syndrome (Triglycerides)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|3 months|||mg/dl||Standard Deviation|Mean
795374|NCT00923260|Primary|Components of Metabolic Syndrome (Triglycerides)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 month|||mg/dl||Standard Deviation|Mean
795375|NCT00923260|Primary|Components of Metabolic Syndrome (Triglycerides)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|Basal|||mg/dl||Standard Deviation|Mean
795376|NCT00923260|Primary|Components of Metabolic Syndrome (Total Cholesterol)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 year|||mg/dl||Standard Deviation|Mean
795377|NCT00923260|Primary|Components of Metabolic Syndrome (Total Cholesterol)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|6 months|||mg/dl||Standard Deviation|Mean
795378|NCT00923260|Primary|Components of Metabolic Syndrome (Total Cholesterol)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|3 months|||mg/dl||Standard Deviation|Mean
795379|NCT00923260|Primary|Components of Metabolic Syndrome (Total Cholesterol)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 month|||mg/dl||Standard Deviation|Mean
795380|NCT00923260|Primary|Components of Metabolic Syndrome (Total Cholesterol)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|Basal|||mg/dl||Standard Deviation|Mean
795381|NCT00923260|Primary|Components of Metabolic Syndrome (Insulin)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 year|||μU/μL||Standard Deviation|Mean
795382|NCT00923260|Primary|Components of Metabolic Syndrome (Insulin)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|6 months|||μU/μL||Standard Deviation|Mean
795383|NCT00923260|Primary|Components of Metabolic Syndrome (Insulin)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|3 months|||μU/μL||Standard Deviation|Mean
795384|NCT00923260|Primary|Components of Metabolic Syndrome (Insulin)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|Basal|||μU/μL||Standard Deviation|Mean
795385|NCT00923260|Primary|Components of Metabolic Syndrome (Glucose)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 year|||mg/dl||Standard Deviation|Mean
795386|NCT00923260|Primary|Components of Metabolic Syndrome (Glucose)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|6 months|||mg/dl||Standard Deviation|Mean
795387|NCT00923260|Primary|Components of Metabolic Syndrome (Glucose)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|3 months|||mg/dl||Standard Deviation|Mean
795388|NCT00923260|Primary|Components of Metabolic Syndrome (Glucose)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 month|||mg/dl||Standard Deviation|Mean
795389|NCT00923260|Primary|Components of Metabolic Syndrome (Glucose)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|Basal|||mg/dl||Standard Deviation|Mean
795390|NCT00923260|Primary|Components of Metabolic Syndrome (Diastolic Blood Pressure)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 year|||mmHg||Standard Deviation|Mean
795391|NCT00923260|Primary|Components of Metabolic Syndrome (Diastolic Blood Pressure)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|6 months|||mmHg||Standard Deviation|Mean
795392|NCT00923260|Primary|Components of Metabolic Syndrome (Diastolic Blood Pressure)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|3 months|||mmHg||Standard Deviation|Mean
795393|NCT00923260|Primary|Components of Metabolic Syndrome (Diastolic Blood Pressure)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 month|||mmHg||Standard Deviation|Mean
795394|NCT00923260|Primary|Components of Metabolic Syndrome (Diastolic Blood Pressure)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|Basal|||mmHg||Standard Deviation|Mean
795395|NCT00923260|Primary|Components of Metabolic Syndrome (Systolic Blood Pressure)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 year|||mmHg||Standard Deviation|Mean
795396|NCT00923260|Primary|Components of Metabolic Syndrome (Systolic Blood Pressure)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|6 months|||mmHg||Standard Deviation|Mean
795397|NCT00923260|Primary|Components of Metabolic Syndrome (Systolic Blood Pressure)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|3 months|||mmHg||Standard Deviation|Mean
795398|NCT00923260|Primary|Components of Metabolic Syndrome (Systolic Blood Pressure)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 month|||mmHg||Standard Deviation|Mean
795399|NCT00923260|Primary|Components of Metabolic Syndrome (Systolic Blood Pressure)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|Basal|||mmHg||Standard Deviation|Mean
795400|NCT00923260|Primary|Components of Metabolic Syndrome (Body Mass Index)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 year|||Kg/m2||Standard Deviation|Mean
795401|NCT00923260|Primary|Components of Metabolic Syndrome (Body Mass Index)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|6 months|||Kg/m2||Standard Deviation|Mean
795402|NCT00923260|Primary|Components of Metabolic Syndrome (Body Mass Index)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|3 months|||Kg/m2||Standard Deviation|Mean
795403|NCT00923260|Primary|Components of Metabolic Syndrome (Body Mass Index)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 month|||Kg/m2||Standard Deviation|Median
795404|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (Interleukine-6)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement|Basal|||pg/ml||Standard Deviation|Mean
795405|NCT00923260|Primary|Components of Metabolic Syndrome (Body Mass Index)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|Basal|||Kg/m2||Standard Deviation|Mean
795406|NCT00923845|Secondary|Percentage of Cluster of Differentiation 4 (CD4)+ T Cells Expressing the T-reg Transcription Factor Forkhead Box P3 (FoxP3))|CD4+ T cells were analyzed by flow cytometry for intracellular expression of FoxP3.|Days 14, 60, and 100 post transplant|The values for each subset were stable at days 60 and 100 relative to day 14 values.||Percentage of total CD4+ T cells||Full Range|Median
795407|NCT00923845|Secondary|Percentage of Cluster of Differentiation 4 (CD4)+ T Cells Expressing the Th1 Transcription Factor T-bet|CD4+ T cells were analyzed by flow cytometry for intracellular detection of Tbet transcription factor.|Days 14, 60, and 100 post transplant|The values for each subset were stable at days 60 and 100 relative to day 14 values.||Percentage of total CD4+T cells||Full Range|Median
795408|NCT00923845|Secondary|Percentage of Cluster of Differentiation 4 (CD4)+ T Cells Expressing the Th2 Transcription Factor GATA Binding Protein 3 (GATA-3)|Intra-cellular flow cytometry detection of GATA3 transcription factor.|Days 14, 60 and 100 post transplant|The values for each subset were stable at days 60 and 100 relative to day 14 values.||Percentage of total CD4+ T cells||Full Range|Median
795409|NCT00923845|Secondary|Cluster of Differentiation 8 (CD8)+ T Cells Immune Reconstitution|CD8+ T Cells immune reconstitution is defined as distribution of CD8+ T cells subsets within naïve, central memory, effector memory, and effector memory-RA cells analyzed by flow cytometry.|Days 14, 60, and 100 post transplant|The values for each subset were stable at days 60 and 100 relative to day 14 values.||Percent of total CD8 cell subsets||Standard Deviation|Median
795450|NCT00924040|Secondary|Correlation Between Number of Prior Cycles of BL22 With Immunogenicity on This Protocol|Percent of patients neutralizing >75% of 1000 ng/ml of BL22 in a biologic assay by end of treatment, with respect to the number of prior cycles of BL22 prior to entry on this protocol|Within 2 months of end of treatment ( measure antibodies before each cycle)|||correlation coefficient|||Number
795410|NCT00923845|Secondary|Cluster of Differentiation 4 (CD4) T Cells Immune Reconstitution|CD4 T Cells immune reconstitution is defined as distribution of CD4+ T cells subsets within naïve, central memory, effector memory, and effector memory-RA cells analyzed by flow cytometry.|Days 14, 60, and 100 post transplant|The values for each subset were stable at days 60 and 100 relative to day 14 values.||Percentage of total CD4 cell subsets||Standard Deviation|Median
795411|NCT00923845|Secondary|Count of Patients With Chronic Graft Versus Host Disease (GVHD)|Chronic GVHD was assessed by the 2005 Chronic GVHD Consensus Project. Chronic GVHS may include dryness of the mouth and eyes, weight loss, liver damage and lung damage leading to cough and shortness of breath (i.e. skin Grading: no symptoms = 0, <18% body surface area (BSA) = 1, 19-50% BSA = 2, and >50% BSA = 3); oral cavity Grading: no symptoms = 0, mild symptoms = 1, moderate symptoms =2 and severe symptoms =3)).|For the duration of post-transplant follow-up|Only 4 patients were evaluable due to mortality from malignancy.||Participants|||Count of Participants
795412|NCT00923845|Secondary|Count of Patients With Late Acute Graft Versus Host Disease (GVHD) After Day 100 Post-Transplant|Acute GVHD is assessed by the 1994 Consensus Conference on Acute GVHD grading criteria. Acute GVHD is assessed by the 1994 Consensus Conference on Acute GVHD grading criteria. Acute GVHD may include rash, diarrhea, and liver damage (i.e. rash Grading: <25% body surface area (BSA) = 1, rash 25-50% BSA = 2, generalized erythroderma = 3, and desquamation and bullae = 4); liver Grading: total bilirubin 2-3 mg/dl = 1, total bilirubin 3-6 mg/dl =2, total bilirubin 6-15 mg/dl =3, and total bilirubin >15 mg/dl = 4)).|100 days post-transplant through 5 years post-transplant|Only 6 patients were evaluable for this endpoint due to death due to malignancy.||Participants|||Count of Participants
795413|NCT00923845|Secondary|Count of Patients With Grade II or Greater Acute Graft Versus Host Disease (GVHD) in First 100 Days Post-Transplant|Acute GVHD is assessed by the 1994 Consensus Conference on Acute GVHD grading criteria. Acute GVHD may include rash, diarrhea, and liver damage (i.e. rash Grading: <25% body surface area (BSA) = 1, rash 25-50% BSA = 2, generalized erythroderma = 3, and desquamation and bullae = 4); liver Grading: total bilirubin 2-3 mg/dl = 1, total bilirubin 3-6 mg/dl =2, total bilirubin 6-15 mg/dl =3, and total bilirubin >15 mg/dl = 4)).|100 days post transplant|||Participants|||Count of Participants
795414|NCT00923845|Secondary|Engraftment Donor T Cell and Myeloid Cell Chimerism|Donor Genetic Elements by variable number tandem repeat-polymerase chain reaction (VNTR-PCR) Analysis.|Days 14, 28, 45, and 60 post transplant|||Percent Donor by VNTR-PCR Analysis||Full Range|Median
795415|NCT00923845|Secondary|Immune Suppression|Immune suppression is defined by the frequency of elimination of a pre-transplant T cell cytokine value.|Cytokine analysis at baseline and within 24 hours of completion of the pentostatin/cyclophosphamide regimen|||% of undetectable cytokine measurements|||Number
795416|NCT00923845|Secondary|Immune Depletion in Cluster of Differentiation 8 (CD8)+ T Cells|Reduction in cluster of differentiation 8 (CD8)+ T cells [change in median values and (range of values)].|Baseline and day 21 (completion of the pentostatin/cyclophosphamide regimen)|||cells/µL||Full Range|Median
795417|NCT00923845|Secondary|Immune Depletion in Cluster of Differentiation 4 (CD4) Cells|Reduction in cluster of differentiation 4 (CD4)+ T cells [change in median values and (range of values)].|Baseline and day 21 (completion of the pentostatin/cyclophosphamide regimen)|||Cells/µL||Full Range|Median
795418|NCT00923845|Secondary|Count of Patients Having an Infectious Complication Attributable to the Pentostatin and Cyclophosphamide (PC) Regimen|Occurrence of infection by Common Terminology Criteria for Adverse Events (CTCAE).|During the 21-day PC regimen|||Participants|||Count of Participants
795419|NCT00923845|Secondary|Count of Patients Having Neutropenia Attributable to the Pentostatin and Cyclophosphamide (PC) Regimen|Absolute neutrophil count determination by complete blood count methodology (Absolute Neutrophil Count (ANC) < 500 Cells/µL).|During the 21-day PC regimen|||Participants|||Count of Participants
795420|NCT00923845|Secondary|Count of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|50 months and 6 days|||Participants|||Count of Participants
795421|NCT00923845|Primary|Clinical Regression of Metastatic Renal Cell Carcinoma (Partial Response (PR)) or Complete Remission of Tumor (Complete Response (CR))|Response was assessed by computed tomography measurements and the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the largest diameter (LD) of target lesions, taking as reference the baseline sum LD. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest LD recorded since the treatment started or the appearance of one or more new lesions.|6 Months Post-Transplant (Day +100)|||participants|||Number
795422|NCT00923910|Secondary|Number of Participants With Progressive Disease|Progressive disease is at least a 20% increase in the sum of the longest diameter of all target lesions (i.e. tumor response). Response criteria for acute leukemia's is worse marrow classification (i.e., M status) with at least a 50% increase in the percentage of marrow blasts, or no change in marrow classification (i.e., M status), but a 50% or greater increase in absolute peripheral blast count or extent of medullary disease|4 to12 weeks|The donor arm is not included here because they were not evaluated for this outcome measure; recipients only.||participants|||Number
795423|NCT00923910|Secondary|Keyhole Limpet Hemocyanin (KLH) Delayed-type Hypersensitivity (DTH)|KLH is a neoantigen known to induce helper response was used concurrently as a vaccine adjuvant and control antigen. DTH skin testing was performed using KLH and with a cocktail of WT1 peptides as 2 separate injections. Enzyme-Linked Immunospot (ELISpot) was performed against each peptide and was considered positive if results were at least 10 spots above background on at least 2 measurements. DTH was considered positive if there was at least .5cm induration 48 to 72 hours after placement.|48 to 72 hours after placement|The donor arm is not included here because they were not evaluated for this outcome measure; recipients only.||participants|||Number
795434|NCT00923949|Secondary|Number of Participants With Effects of Pioglitazone on Serum Tumor Markers|C-reactive protein, cancer antigen 15-3 (CA 15-3), cancer antigen 125 (CA-125) and carcinoembryonic antigen (CEA) will be assessed by immunohistochemistry.|58 days|No participants were analyzed because only one participant went on study and he did not undergo the requisite lung cancer resection due to disease progression, which means there was insufficient tissue to perform all the secondary tumor marker analyses. There is no statistical power to draw any conclusions and thus the data are not informative.|||||
795424|NCT00923910|Secondary|Wilm's Tumor (WT1) Delayed-type Hypersensitivity (DTH)|WT1 expression of the hematologic malignancy was confirmed by either having greater than 15% of malignant cells react with anti-WT1 by immunohistochemistry or by having a positive quantitative reverse transcription polymerase chain reaction (RT-PCR) of WT1 compared with a negative control. DTH skin testing was performed using KLH and with a cocktail of WT1 peptides as 2 separate injections. Enzyme-Linked Immunospot (ELISpot) was performed against each peptide and was considered positive if results were at least 10 spots above background on at least 2 measurements. DTH was considered positive if there was at least .5cm induration 48 to 72 hours after placement.|48 to 72 hours after placement|The donor arm is not included here because they were not evaluated for this outcome measure; recipients only.||participants|||Number
795425|NCT00923910|Secondary|Wilm's Tumor 1 (WT1) Enzyme-Linked Immunospot (ELISpot)|WT1 expression of the hematologic malignancy was confirmed by either having greater than 15% of malignant cells react with anti-WT1 by immunohistochemistry or by having a positive quantitative reverse transcription polymerase chain reaction (RT-PCR) of WT1 compared with a negative control.|48 to 72 hours after placement|The donor arm is not included here because they were not evaluated for this outcome measure; recipients only.||participants|||Number
795426|NCT00923910|Secondary|Time to Immune Response|Immune response was monitored by use of interferon gamma Enzyme-Linked Immunospot (ELISpot) and by delayed-type hypersensitivity (DTH) testing.|4 to 12 weeks|The donor arm is not included here because they were not evaluated for this outcome measure; recipients only.||Weeks|||Number
795427|NCT00923910|Primary|Number of Participants With Graft Versus Host Disease (GVHD) Greater Than or Equal to Grade 3|Acute Graft versus Host Disease (GVHD) was graded by the modified Glucksberg scale. 0 = no GVHD normal, 4 = severe GVHD.|28 days following completion of last vaccine and/or DLI (donor lymphocyte infusion) administration|Data for the frequency and severity of GVHD was captured as an endpoint for this trial. The donor arm is not included here because they were not evaluated for this outcome measure; recipients only.||participants|||Number
795428|NCT00923910|Primary|Toxicity|Here is the number of participants with adverse events. For details of the adverse events, see the adverse event module.|21 months|Only recipients were monitored for adverse events.||participants|||Number
795429|NCT00923936|Secondary|Percentage of Participants With 12- Month Progression-free Survival (PFS)|Participants who survived and were progression free for 12 months. Response was assessed by a modification of the Acquired Immune Deficiency Syndrome Clinical Trial Group Oncology Committee criteria. Progressive disease is an increase of 25% or more over baseline in the number of lesions and/or size (sum of the products of the largest perpendicular diameters) of the marker lesions or a change in character from macular to plaque-like or nodular of at least 25% of the lesions or new visceral sites of involvement or progression of visceral disease or the development of new or increasing tumor-associated edema or effusion that lasts at least 1 week and interfered with the patient's normal activities.|12 months|||percentage of participants||95% Confidence Interval|Number
795430|NCT00923936|Secondary|Median Number of Cycles Need to Obtain a Partial Response|Response was assessed by a modification of the Acquired Immune Deficiency Syndrome Clinical Trial Group Oncology Committee criteria. Partial response is no progressive disease (increase of 25% or more over baseline in the number of lesions and/or size (sum of the products of the largest perpendicular diameters of the marker lesions) and noting that single lesions which split up into 2 or more smaller lesions during the course of treatment will still be counted as 1; no new lesions occurring in previously uninvolved areas of the body; no new visceral sites of involvement or the appearance or worsening of tumor-associated edema or effusions and a 50% or greater decrease in the number and/or size of previously existing lesions lasting for at least 4 weeks or complete flattening of at least 50% of all previously raised lesions (i.e., 50% of all previously nodular or plaque-like lesions become macular) lasting for at least 4 weeks.|6 cycles, an average of 18 weeks|||Cycles||95% Confidence Interval|Median
795431|NCT00923936|Secondary|Count of Participants With Serious and Non-serious Adverse Events|Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|7 years and 6 months and 21 days|||Participants|||Count of Participants
795432|NCT00923936|Secondary|Complete Response Rate After 6 Cycles of Liposomal Doxorubicin Combined With Bevacizumab|Complete response rate is the fraction of subjects with an complete response after 6 cycles of liposomal doxorubicin in combination with bevacizumab. Response was assessed by a modification of the Acquired Immune Deficiency Syndrome Clinical Trial Group Oncology Committee criteria. Complete response is the absence of any detectable residual disease, including tumor-associated edema, persisting for at least 4 weeks. In patients whom pigmented macular skin lesions persist after apparent complete response, biopsy of at least one representative lesion is required to document the absence of malignant cells. In patients known to have had visceral disease, an attempt at restaging with appropriate endoscopic or radiographic procedures should be made. If such procedures are medically contraindicated, the patient may be classified as having a clinical complete response.|6 cycles, an average of 18 weeks|No patients had a complete response.||percentage of participants||80% Confidence Interval|Number
795433|NCT00923936|Primary|Overall Response Rate (ORR) of Six Cycles of Liposomal Doxorubicin Combined With Bevacizumab in Patients With Advanced KS.|Overall response rate is complete response + clinical complete response + partial response. The overall response rate is the fraction of subjects with an overall response after 6 cycles of liposomal doxorubicin in combination with bevacizumab. Response was assessed by a modification of the Acquired Immune Deficiency Syndrome Clinical Trial Group Oncology Committee criteria. Complete response is the absence of any detectable residual disease, including tumor-associated edema, persisting for at least 4 weeks. Clinical complete response is the absence of any detectable residual disease, including tumor associated edema. persisting for at least 4 weeks. Partial response is no progressive disease (increase of 25% or more over baseline in the number of lesions and/or size (sum of the products of the largest perpendicular diameters of the marker lesions) & noting that single lesions which split up into 2 or more smaller lesions during the course of treatment will still be counted as 1.|6 cycles, an average of 18 weeks|||percentage of participants||80% Confidence Interval|Number
795435|NCT00923949|Secondary|Number of Participants With Effects of Pioglitazone on Histologically Normal Tissue Biomarkers|ki-67 and peroxisome proliferator-activated receptor gamma (PPARgamma) will be assessed by immunohistochemistry.|58 days|No participants were analyzed because only one participant went on study and he did not undergo the requisite lung cancer resection due to disease progression, which means there was insufficient tissue to perform all the secondary tumor marker analyses. There is no statistical power to draw any conclusions and thus the data are not informative.|||||
795436|NCT00923949|Secondary|Number of Participants With Effects of Pioglitazone on Premalignant Tissue Biomarkers|Premalignant tissue biomarkers ki-67, apoptotic index and peroxisome proliferator-activated receptor gamma (PPARgamma) will be assessed by immunohistochemistry.|58 days|No participants were analyzed because only one participant went on study and he did not undergo the requisite lung cancer resection due to disease progression, which means there was insufficient tissue to perform all the secondary tumor marker analyses. There is no statistical power to draw any conclusions and thus the data are not informative.|||||
795437|NCT00923949|Secondary|Number of Participants With Metabolic Activity Determined by Fludeoxyglucose Positron-emission Tomography (FDG-PET)|Response will be evaluated by FDG-PET. Response is defined as a decrease of standardized uptake values (SUV) of more than one.|58 days|No participants were analyzed because only one participant went on study and he did not undergo the requisite lung cancer resection due to disease progression, which means there was insufficient tissue to perform all the secondary tumor marker analyses. There is no statistical power to draw any conclusions and thus the data are not informative.|||||
795438|NCT00923949|Secondary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For details about the adverse events see the adverse event module.|58 days|||Participants|||Number
795439|NCT00923949|Secondary|Number of Participants With Effects of Pioglitazone on Multiple Biomarkers in Tumor|Apoptotic index (A1) will be assessed by terminal deoxynucleotidyl transferase dUTP end labeling (TUNEL) and cyclin D1, p21/Waf1, PPARy, MUC1, gelsolin, proline oxidase, and 15-hydroxyprostaglandin dehydrogenase (15-PGDH) will be assessed by immunohistochemistry.|58 days|No participants were analyzed because only one participant went on study and he did not undergo the requisite lung cancer resection due to disease progression, which means there was insufficient tissue to perform all the secondary tumor marker analyses. There is no statistical power to draw any conclusions and thus the data are not informative.|||||
795440|NCT00923949|Primary|Number of Participants With a Change in Ki-67 Due to the Effect of Pioglitazone in Tumor Tissue|Antigen ki-67 (Ki-67) will be assessed by immunohistochemistry.|58 days|No participants were analyzed because only one participant went on study and he did not undergo the requisite lung cancer resection due to disease progression, which means there was insufficient tissue to perform all the secondary tumor marker analyses. There is no statistical power to draw any conclusions and thus the data are not informative.|||||
795441|NCT00923975|Primary|Number of Participants Out of 50 Rated Successful (<=3) by Healthcare Professionals When Participants Performed Specific Software Tasks|"Study staff rated participants on their success at performing specific tasks. The rating scale was:
= Successful ( no assistance)
= Successful after staff prompted to view user instructions
= Successful with verbal assistance or review of part of user instructions (as review a specific function during a Customer Service call)
= Unsuccessful (Subject could not perform the task)
= Subject could not perform task due to software or hardware failure after repeated attempt."|1-2 hours|One subject was withdrawn from the study and the data was not used in the analysis. The subject did not meet inclusion criteria.||participants|||Number
795442|NCT00923975|Secondary|Number of Participants Out of 50 Who Rated Their Satisfaction With The Following as Good to Excellent (>=3)|"Subjects responded to questionnaires in rating features and appearance, usefulness, and satisfaction on a 5 point scale:
= Unacceptable
= Poor
= Good
= Very Good
= Excellent"|1-2 hours|One subject was withdrawn from the study and the data was not used in the analysis. The subject did not meet inclusion criteria.||participants|||Number
795443|NCT00923975|Secondary|Number of Participants Who Rated Clarity and Usefulness of User Instructions as Good to Excellent (>=3)|"After the software evaluation, subjects were asked to review the online help and rate it on a 5 point scale.
= Unacceptable
= Poor
= Good
= Very Good
= Excellent"|1-2 hours|The number of results analyzed was less than 50 because some subjects had no opinion. One subject had no opinion of clarity of online help overall and three subjects had no opinion of usefulness of online help overall.||participants|||Number
795444|NCT00923975|Secondary|Number of Participants Out of 50 Who Rated Ease of Performing Specific Tasks as Very Simple to Neither Simple Nor Difficult (<=3 Rating)|"Subjects rated ease of using the software with respect to specific tasks. The rating scale was:
= Very Simple
= Simple
= Neither Simple nor Difficult
= Difficult
= Very Difficult"|1-2 hours|One subject was withdrawn from the study and the data was not used in the analysis. The subject did not meet inclusion criteria.||participants|||Number
795445|NCT00924001|Secondary|Number of Participiants With In-vivo Survival of Infused Cells|In-vivo survival of infused cells is determined by analysis of the sequence of the variable region of the T cell receptor or flow cytometry (FACS).|44 days|||Participants|||Number
795446|NCT00924001|Primary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|44 days|||Participants|||Number
795447|NCT00924001|Primary|Number of Participants With an Objective Clinical Tumor Regression Response According to RECIST Criteria|Response is determined by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is the disappearance of all target lesions, partial response (PR) is at least a 30% decrease in the target lesions, progression (PD) is at least a 20% increase in the target lesions or appearance of one or more new lesions, and stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|44 days|||Participants|||Number
795448|NCT00924040|Secondary|Percentage of Patients Who Have Dose Limiting Toxicity (DLT)|Determination of dose limiting toxicity (DLT) is by the standard toxicity assessment Common Terminology Criteria for Adverse Events version 3.0 (CTCAEv3.0) done every cycle. For detailed information about the CTCAEv3.0 see the protocol Link module.|24 weeks|||Percentage of participants|||Number
795449|NCT00924040|Secondary|Percentage of Patients Who Make Antibodies|Determination of antibodies against BL22 is determined by the Clinical Laboratory Improvement Amendments (CLIA) certified blood tests in our contract lab. NCI-Frederick in the laboratory of Dr. David Waters (Science Applications International Corporation (SAIC). He is CLIA certified.|24 weeks|||Percentage of participants|||Number
795451|NCT00924040|Secondary|Percentage of Patients Who Respond Clinically, Who Also Have Normalization in sCD22 or sCD25|CD25 (sCD25)and CD22 (sCD22) quantify hairy cell leukemia (HCL) tumor burden. Patients with either PR or CR are evaluated for soluble forms of CD25 (sCD25) and soluble CD22 (sCD22). The number of patients with PR or CR who have normalization of sCD25 and sCD22 will be recorded. Normalization is considered <3 ng/ml for sCD25, and <2 ng/ml for sCD22. Patients will be assessed for normalization of sCD25 and sCD22 for at least 12 months after achieving PR or CR.|patients may undergo lymphapheresis before the first and/or later cycles up to 12 months after achieving CR or PR|||Percentage of participants|||Number
795452|NCT00924040|Secondary|Number of Patients With ex Vivo Sensitivity Who Respond Clinically|Although some hairy cell leukemia (HCL) cells from some patients may have ex vivo sensitivity, they might not respond clinically. Number of participants with pretreatment ex vivo sensitivity (<10 ng/ml IC50) who go on to achieve CR as best response. CR required abscence of HCL in the bone marrow and resolution of cytopenias.|Time to CR can be between 2 months and 1 year|||Participants|||Number
795453|NCT00924040|Secondary|Number of Patients Who Developed Neutralizing Antibodies After One or More Cycles of BL22|Fresh malignant cells are isolated from blood, bone marrow, lymph nodes or other tissue and incubated with recombinant immunotoxins to determine sensitivity to BL22 and other agents to estimate the amount of cancer cells in the body by measuring proteins which fall off cancer cells and go into the blood.|24 weeks|||Participants|||Number
795454|NCT00924040|Secondary|Number of Participants With Complete Response (CR) Who Resolve the Bone Marrow Abnormality by Magnetic Resonance Imaging (MRI)|Patients are assessed by MRI to determine which ones resolve their marrow abnormality. A non-parametric Wilcoxon test was to be used to determine whether CR correlated with resolution of MRI abnormality|Bone marrow biopsy and MRI 4 weeks after patients meeting blood criteria for CR, and if CR is present, repeat bone marrow biopsy and MRI every 12 months. Bone marrow biopsy and MRI is not done in patients with PR as best response.|||Participants|||Number
795455|NCT00924040|Secondary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|2 years & 6 months|||Participants|||Number
795456|NCT00924040|Primary|Number of Months to Response to Treatment|Response is defined by the Response Evaluation Criteria in the protocol, namely the earliest point where all relevant tests (i.e. lab tests, physical exam, radiology results) are consistent with complete response (CR) or partial response (PR). CR or PR must be confirmed for at least 4 weeks. Complete response: No evidence of leukemic cells by routine H/E stains of the peripheral blood and bone marrow. Partial response:neutrophils >/= 1,500/micrograms/L or 50% improvement over baseline without growth factors for at least 4 weeks.|2/14/2009 till 6/24/2010|||Months|||Number
795457|NCT00924053|Primary|Vz/F|Apparent volume of distribution|3 days|||mL||Standard Deviation|Mean
795458|NCT00924053|Primary|CL/F|The apparent rate of oral clearance of EGT0001474.Oral clearance was defined as rate of drug removal from the body after oral administration.|3 days|||mL/hr||Standard Deviation|Mean
795459|NCT00924053|Primary|t1/2|Apparent terminal half life|3 days|||hour||Standard Deviation|Mean
795460|NCT00924053|Primary|λz|Terminal phase rate constant|3 days|||1/hour||Standard Deviation|Mean
795461|NCT00924053|Primary|Tmax|Time of maximum plasma concentration|3 days|||hour||Full Range|Median
795462|NCT00924053|Primary|Cmax|Maximum plasma concentration|3 days|||ng/mL||Standard Deviation|Mean
795463|NCT00924053|Primary|AUC Inf|Area under the plasma concentration-time curve from time 0 to infinity|3 days|||ng*hr/mL||Standard Deviation|Mean
795464|NCT00924053|Primary|AUC0-24|Area under the plasma concentration-time curve from time 0 to hour 24|3 days|||ng*hr/mL||Standard Deviation|Mean
795465|NCT00924053|Primary|AUC 0-t|Area under the plasma concentration-time curve from time 0 to time t|3 days|||ng*hr/mL||Standard Deviation|Mean
795466|NCT00924053|Primary|Safety and Tolerability of EGT0001474|Safety and tolerability were measured in terms of the number of mild, moderate and severe adverse events experienced by any participants.|25 days|All patients who took study medication were included in the analysis.||Events|||Number
795467|NCT00924066|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|61 months|Adverse events are grouped together because the histology cohort has no bearing on the adverse events.||participants|||Number
795468|NCT00924066|Primary|Tumor Response (PR + CR) Per RECIST|Establish the efficacy of the investigational agent Ixabepilone in patients with cervical carcinoma per the Response Evaluation Criteria in Solid Tumors (RECIST) when Ixabepilone is administered as a daily 1 hour infusion on days 1-5 every 3 weeks. Complete response (CR) is the disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. Not evaluable (NE) means the participant was not evaluable because there was not a scan available to compare to the baseline scan.|Every 6 weeks, up to 15 months|||participants|||Number
795469|NCT00924118|Secondary|Left Ventricular Infarct Size|Left ventricular infarct size by magnetic resonance imaging. Calculated percentage of the left ventricular mass by MRI that has undergone infarction.|4-5 days following enrollment|Too few subjects underwent MRI imaging to make a statistical comparison. Only those where data was obtained has been reported.||infarct percentage of left ventricle||Full Range|Mean
795470|NCT00924118|Primary|Primary Efficacy Outcome is a to Determine Whether Sodium Nitrite Safely Reduces Infarct Size Normalized for the Ischemia Area at Risk as Determined by Paired Single-photon Computed Tomography Studies With Technetium Tc99m Sestamibi.|"Primary efficacy outcome is a to determine whether sodium nitrite safely reduces infarct size normalized for the ischemia area at risk as determined by paired single-photon computed tomography studies with technetium Tc99m sestamibi.
Too few subjects received Tc99m sestamibi to make statistical comparisons between the groups regarding infarct size normalized for the ischemia area at risk."|4-5 days from enrollment|Sestamibi imaging proved impossible to obtain emergently and therefore no data was collected.|||||
796271|NCT00928408|Primary|Cinacalcet Dosing Frequency|Cinacalcet dosing frequency at Month 6|Month 6|Full Analysis Set - Participants with Observed Data||Participants|||Number
795471|NCT00924170|Secondary|Count of Participants With Adverse Events Attributed At Least Possibly to Patients Treated With Fludarabine and Cyclophosphamide Dose Levels 20+200, 25+250, and 30+300 mg/m^2|Adverse events is assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|7 years and 12 days|*Grade 5 (death) event. Data for this outcome measure is reported as in the publication noted in the References module.||Participants|||Count of Participants
795472|NCT00924170|Secondary|Count of Participants With Grades 3-5 Adverse Events of > 1 Adult T-Cell Leukemia (ATL) Patients Treated With 20+200, 25+250, and 30+300 mg/m^2 LMB-2/Fludarabine and Cyclophosphamide|Adverse events is assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. Grade 3 (mild), Grade 4 (life threatening) and Grade 5 (death).|7 years and 12 days|Data for this outcome measure is reported as in the publication noted in the References module.||Participants|||Count of Participants
795473|NCT00924170|Secondary|Half Life (t1/2) of LMB-2|Dilutions of patient plasma was tested by cytotoxicity assays to determine half life. Plasma decay half-life is the time measured for the plasma concentration of the drug to decrease by one half.|First 24 hours after the dose given on Cycle 2, day 1|Three participants were non-evaluable. One participant withdrew due to inability to receive second cycle, which was the first cycle containing LMB-2. One participant had progressive disease before first cycle of LMB2, and one participant had progressive disease after first cycle of LMB2||min||Full Range|Median
795474|NCT00924170|Secondary|Volume of Distribution of LMB-2|Dilutions of patient plasma were tested by cytotoxicity assays to determine volume of distribution of LMB-2. Volume distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. This was measured during the first 24 hours after administration of the dose on cycle 2 day 1.|24 hours|Three participants were non-evaluable. One participant withdrew due to inability to receive second cycle, which was the first cycle containing LMB-2. One participant had progressive disease before first cycle of LMB2, and one participant had progressive disease after first cycle of LMB2||Liters||Full Range|Median
795475|NCT00924170|Secondary|Plasma Clearance (CL) of LMB-2|Dilutions of patient plasma was tested by cytotoxicity assays to determine plasma clearance of LMB-2.The CL is a quantitative measure of the rate at which a drug substance is removed from the body.|First 24 hours after the dose given on Cycle 2, day 1|Three participants were non-evaluable. One participant withdrew due to inability to receive second cycle, which was the first cycle containing LMB-2. One participant had progressive disease before first cycle of LMB2, and one participant had progressive disease after first cycle of LMB2||mL/min||Full Range|Median
795476|NCT00924170|Secondary|Duration of Response (Complete Response + Partial Response)|Duration of response is defined as a response lasting for at least 4 weeks but >8 weeks and is assessed by the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma. Complete remission (CR) is complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease related symptoms if present before therapy and normalization of those biochemical abnormalities definitely assignable to the lymphoma. Partial response is reduction by ≥50% of leukemia cell count or ≥50% reduction in the size of all measurable lesions, and no increase in size of any measurable or evaluable lesion or appearance of new lesion.|69 months|||Weeks||95% Confidence Interval|Median
795477|NCT00924170|Secondary|Percentage of Patients Who Developed Neutralizing Antibodies After One or More Cycles of LMB-2|Blood was drawn prior to each cycle of LMB-2 to determine if the level, >75% neutralization of 1000ng/ml of LMB-2 of neutralizing antibodies is too high to give additional LMB-2. Analysis was performed by cytotoxicity assay.|First 24 hours after the dose given on Cycle 2, day 1|Three participants were non-evaluable. One participant withdrew due to inability to receive second cycle, which was the first cycle containing LMB-2. One participant had progressive disease before first cycle of LMB2, and one participant had progressive disease after first cycle of LMB2||percentage of participants||95% Confidence Interval|Number
795478|NCT00924170|Secondary|Post Treatment Effects of LMB-2 + Fludarabine and Cyclophosphamide (FC) on Normal B and T Cell Subsets by Flow Cytometry|Peripheral blood was obtained and analyzed by flow cytometry.|First 24 hours after the dose given on Cycle 2, day 1|One patient did not have flow cytometry measuring it.||Cells/µL||Full Range|Median
795479|NCT00924170|Secondary|Area Under the Plasma Concentration (AUC) - LMB2|AUC is a measure of the plasma concentration of drug over time. It is used to characterize drug absorption. Plasma levels were analyzed by cytotoxicity assay.|First 24 hours after the dose given on Cycle 2, day 1|Three participants were non-evaluable. One participant withdrew due to inability to receive second cycle, which was the first cycle containing LMB-2. One participant had progressive disease before first cycle of LMB2, and one participant had progressive disease after first cycle of LMB2||µg/-min/mL||Full Range|Median
795480|NCT00924170|Secondary|Soluble Cluster of Differentiation 25 (sCD25) Between Responders and Nonresponders|Tumor tissue, including lymph node or skin biopsies was examined and analysis performed by flow cytometry to determine the amount of cancer cells in the body by measuring proteins which fall off cancer cells and go into the blood.|First 24 hours after the dose given on Cycle 2, day 1|The number 8 represents the number of responders in the Arm/Group and the number 2 represents the number of non-responders in the Arm/Group.||pg/ml||Full Range|Median
795494|NCT00924313|Secondary|Standardized Uptake Value (SUV) of Grouping Tumors Based on Gleason Score|Intensity [11C]AC uptake with histopathologic Gleason grade were done with a Spearman rank correlation following prostatectomy. Two biopsies were performed and graded according to tumor pattern. The two grades were added together for a final Gleason score. Gleason score equal to or less than 3+4 is considered low risk. Gleason score equal to or greater than 4+3 is considered high-risk.|2 years|One patient was not imaged because of failed tracer synthesis.||SUV||Standard Deviation|Mean
795481|NCT00924170|Secondary|Number of Participants With Dose Limiting Toxicity (DLT)|DLT is a grade II-IV LMB-2 or fludarabine and cyclophosphamide (FC)-related toxicity, except vascular leak syndrome, alopecia, grade II-III allergic reaction with asymptomatic bronchospasm or urticarial is considered DLT. Grade III aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, and fever are not considered DLT. Grade IV creatine phosphokinase associated with any other DLT or not resolving to <grade II within 2 weeks is considered DLT. Hematologic toxicity is not considered DLT unless it fails to resolve to <grade 2 or baseline by day 18 after cycle 1 or after day 25 after cycles 2-7. DLT from hepatotoxicity, creatine phosphokinase, and vascular leak syndrome is assumed from LMB-2, and hematologic toxicity from fludarabine and cyclophosphamide. Grade III proteinuria lasting <2 weeks after the last dose of LMB-2 is not considered DLT, and needs to resolve to grade 0-2 prior to retreatment.|30 days after last dose of LMB2|||Participants|||Count of Participants
795482|NCT00924170|Secondary|Number of Participants With Serious and Non-serious Adverse Events|Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|7 years and 12 days|||Participants|||Count of Participants
795483|NCT00924170|Secondary|Overall Survival (OS)|OS is the time between the first day of treatment to the day of disease progression. Progressive disease is assessed by the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma, and is the appearance of new lesions, or an increase of 50% or greater in the sum of the product of the perpendicular diameters of the measurable lesions or persistent (at least two determinations) doubling of the peripheral blood leukemic cell count.|70 months|One participant withdrew due to inability to receive second cycle, which was the first cycle containing LMB-2.||Months||95% Confidence Interval|Median
795484|NCT00924170|Secondary|Progression Free Survival (PFS)|PFS was determined by the Kaplan Meier method beginning at the on study date and continuing until progression or last follow-up without progression. Progressive disease is assessed by the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma, and is the appearance of new lesions, or an increase of 50% or greater in the sum of the product of the perpendicular diameters of the measurable lesions or persistent (at least two determinations) doubling of the peripheral blood leukemic cell count.|70 months|||Months||95% Confidence Interval|Median
795485|NCT00924170|Secondary|Peak Level of LMB-2 in Adult T-Cell Lymphoma|The maximum analyte concentration in serum was reported using a cytotoxicity assay measuring the level of LMB-2 in the plasma and using purified LMB-2 as a standard curve.|First 24 hours after the dose given on Cycle 2, day 1|||ng/mL||Full Range|Median
795486|NCT00924170|Primary|Percentage of Participants With a Minimally Durable Clinical Response Rate|Response is based on the International Workshop to Standardize Response Criteria for Non-Hodgkin’s Lymphoma and must last >8 weeks to meet the primary endpoint of the study. Complete remission (CR) is complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease related symptoms if present before therapy and normalization of those biochemical abnormalities definitely assignable to the lymphoma. Partial response is reduction by ≥50% of leukemia cell count or ≥50% reduction in the size of all measurable lesions, and no increase in size of any measurable or evaluable lesion or appearance of new lesion. Stable disease is neither a response nor progressive disease. Progressive disease is appearance of new lesions, or an increase of 50% or greater in the sum of the product of the perpendicular diameters of the measurable lesions or persistent (at least two determinations) doubling of the peripheral blood leukemic cell count.|8 weeks|"All 10 patients receiving LMB-2 and at least 25+250 mg/m^2 Fludarabine/Cyclophosphamide (FC) were evaluable for response.
Of the 8 other patients, only 5 received LMB-2 and were therefore evaluable for response."||percentage of participants||95% Confidence Interval|Number
795487|NCT00924209|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|38 months|||Participants|||Number
795488|NCT00924209|Primary|Rate of Pathologic Complete Response|Complete response is defined as a disappearance of all target lesions and was assessed by the RECIST (Response Evaluation Criteria in Solid Tumors) criteria.|25 weeks|No goals were met because of low accrual for which the study was closed.|||||
795489|NCT00924287|Secondary|Number of Participants With In Vivo Survival of Transfused Cells|In-vivo survival of infused cells is determined by analysis of the sequence of the variable region of the T cell receptor or flow cytometry (FACS).|12 days|||Participants|||Number
795490|NCT00924287|Primary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|12 days|||Participants|||Number
795491|NCT00924287|Primary|Number of Participants With an Objective Clinical Tumor Regression Response|Response Evaluation Criteria in Solid Tumors (RECIST) are used to determine objective clinical response. Complete Rresponse (CR) is the disappearance of all target lesions, partial response (PR) is at least a 30% decrease in the target lesions, progressive disease (PD) is at least a 20% increase in the target lesions or appearance of one or more new lesions, and stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|12 days||||||
795492|NCT00924313|Secondary|11C-Acetate Standardized Uptake Value (SUV)Max and Serum Prostate Specific Antigen (PSA) Levels Using Spearman Correlation|Tumor foci was histopathologically identified and tested to determine SUVmax relative to PSA levels. PSA normal range is 0-4ng/mL.|2 years|One patient was not imaged because of failed tracer synthesis.||SUVmax||Standard Deviation|Mean
795493|NCT00924313|Secondary|Lesion Based Sensitivity Analysis Using Positron Emission Tomography (PET)/Computed Tomography (CT), Multi-parametric Magnetic Resonance Imaging (MP-MRI), Diffusion Weighted-Magnetic Resonance Imaging (DW-MRI), and DCE-MRI.|PET/CT, MP-MRI, DW-MRI, and dynamic contrast enhanced magnetic resonance imaging (DCE-MRI) were used to detect lesion sensitivity.|2 years|One patient was not imaged because of failed tracer synthesis.||percentage of sensitivity||95% Confidence Interval|Number
795546|NCT00924638|Secondary|Use of Oral Anticoagulation (OAC) Drugs|Percentage of subjects who were using OAC drugs at the 12 months follow-up visit|12 months|Number of subjects who completed the 12-months follow-up visit||percentage of participants|||Number
795495|NCT00924313|Secondary|Incidence of Extraprostatic Lesions Accumulating [11C]AC Positron Emission Tomography (PET)/Computed Tomography (CT) Detection|Suspicious lesions noted on biopsy were compared with standard care imaging diagnostic modalities, additional biopsies, and/or clinical follow up performed at the discretion of the referring physician.|2 years|One patient was not imaged because of failed tracer synthesis.||Participants|||Count of Participants
795496|NCT00924313|Secondary|Count of Participants With Physiological Effects of [11C]AC|Buildup of positron emission tomography (PET) radiopharmaceuticals excreted by the urinary system can accumulate in the bladder and limit pelvic imaging. This effect contributes to low physiologic distribution in the pelvis.|2 years|One patient was not imaged because of failed tracer synthesis.||Participants|||Count of Participants
795497|NCT00924313|Secondary|Pelvic Biodistribution of [11C]AC Positron Emission Tomography (PET)/Computed Tomography (CT) Imaging|Pelvic biodistribution was obtained for the prostate tumor, normal prostate and benign prostatic hyperplasia (BPH). Uptake is expressed in standardized uptake value (SUV).|2 years|One patient was not imaged because of failed tracer synthesis.||SUV||Standard Deviation|Mean
795498|NCT00924313|Secondary|Diagnostic Accuracy of the Standardized Uptake Value of [11C]AC Obtained Using Positron Emission Tomography (PET)/Computed Tomography (CT) for Detecting Region (Sextant)-Specific Malignancy Using Receiver Operating Curves (ROC) for a Lesion >0.9cm|The diagnostic accuracy of 11C-Acetate PET/CT imaging in prostate cancer was compared with multi-parametric magnetic resonance imaging (MP-MRI) using sector based analysis, generating receiver-operating-characteristic (ROC) curves (plots of 1-specificity versus sensitivity) for both modalities.|2 years|One patient was not imaged because of failed tracer synthesis.||Percentage ROC curve||95% Confidence Interval|Number
795499|NCT00924313|Secondary|Count of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|2 years|||Participants|||Count of Participants
795500|NCT00924313|Primary|Compare the Biodistribution of 11C-acetate Positron Emission Tomography (PET)/Computed Tomography (CT) Imaging in Tumor and Non Tumorous Regions of the Prostate|Standard uptake values (SUV) measurements of 11C-acetate will be obtained in each sextant (e.g. region) on each patient. Sextant-specific malignancy will be determined pathologically based on a subsequent prostatectomy. Initially, on each patient, we will, average SUV measurements in tumor and non-tumor regions (i.e., sextants with malignancy and no malignancy, respectively). The patient average SUV measurements across tumors and non-tumor regions will then be compared using a paired t-test.|2 years|One patient was not imaged because of failed tracer synthesis.||ng/mL||Standard Deviation|Mean
795501|NCT00924352|Primary|Evaluation of Progression-free Survival (PFS) of the Combination of Dasatinib and Ixabepilone (Phase II)|Disease progression was determined through radiology imaging measurements and by clinical or symptomatic progression during or after treatment. Progression is defined per RECIST v1.0 guidelines as a measurable increase in the smallest diameter of any target lesion, progression of existing non-target lesions, or the appearance of 1 or more new lesions.|PFS was measured from day 1 of treatment until time of progression (assessed about every 8 weeks) or death, whichever came first, for up to 27.2 months.|The Phase II analysis sample of 50 patients includes the 6 patients from the Phase I portion of the study who were treated at the MTD as well as the 44 patients who were enrolled into the Phase II portion of the study.||months||95% Confidence Interval|Median
795502|NCT00924352|Secondary|Incidence of Grade 4 Adverse Events (AEs) With the Combination of Dasatinib and Ixabepilone (Phase II)|All treatment emergent adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0|Adverse events were collected beginning on day 1 of treatment until one month after the end of study treatment.|The Phase II analysis sample of 50 patients includes the 6 patients from the Phase I portion of the study who were treated at the MTD as well as the 44 patients who were enrolled into the Phase II portion of the study.||participants|||Number
795503|NCT00924352|Secondary|Incidence of Grade 3 Adverse Events (AEs) With the Combination of Dasatinib and Ixabepilone (Phase II)|All treatment emergent adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0|Adverse events were collected beginning on day 1 of treatment until one month after the end of study treatment.|The Phase II analysis sample of 50 patients includes the 6 patients from the Phase I portion of the study who were treated at the MTD as well as the 44 patients who were enrolled into the Phase II portion of the study.||participants|||Number
795504|NCT00924352|Secondary|Clinical Benefit Rate of the Combination of Dasatinib and Ixabepilone (Phase II)|Clinical benefit rate was defined as the percentage of participants experiencing stable disease (SD) of at least 24 weeks (from the start of treatment) plus complete response (CR) and partial response (PR). Response was evaluated via changes from baseline in radiological tumor measurements performed after every two treatment cycles and at the end of treatment or time of progression. Response was evaluated using RECIST version 1.0 guidelines, where CR is the disappearance of all target lesions; PR is >=30% decrease in the sum of the longest diameter(LD) of target lesions; SD is neither sufficient shrinkage in sum of longest diameter of target lesions to be PR nor increase of >=20%.|Response to treatment was assessed after about every 8 weeks of treatment, for up to 27.2 months.|||percentage of participants|||Number
795505|NCT00924352|Secondary|Best Overall Response of the Combination of Dasatinib and Ixabepilone (Phase II)|Best overall response is defined as the best response across all time points. Response was evaluated via changes from baseline in radiological tumor measurements performed after every two treatment cycles and at the end of treatment or time of progression. Response was evaluated using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is >=30% decrease in the sum of the longest diameter (LD) of target lesions; Stable Disease (SD) is neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of >=20%; Progressive Disease (PD) is the increase in existing lesions or new lesions.|Response to treatment was assessed after about every 8 weeks of treatment, for up to 27.2 months.|The Phase II analysis sample of 50 patients includes the 6 patients from the Phase I portion of the study who were treated at the MTD as well as the 44 patients who were enrolled into the Phase II portion of the study.||participants|||Number
795547|NCT00924638|Secondary|Incidence of Recurrent Stroke or TIA (Transient Ischemic Attack)|Percentage of subjects with recurrent stroke or TIA within 12 months of follow-up|12 months|Intention-to-treat (ITT) population (all randomized subjects)||percentage of participants|||Number
798353|NCT00939211|Secondary|Heart Rate, Average Effect Over 0 - 4 Hours Post-dose|Average heart rate value|0, 30 min, 2 h, 4 h|||bpm||Standard Deviation|Mean
795506|NCT00924352|Primary|Determination of the Dose Limiting Toxicities (DLTs) of the Combination of Dasatinib and Ixabepilone (Phase I)|DLTs were assessed using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Dose limiting toxicity was defined as any grade 4 hematologic event or any grade 3 or 4 non-hematologic event occurring during cycle 1 that is attributable to dasatinib, ixabepilone, or the combination. The following events were excluded from this definition: grade 4 neutropenia lasting for 3 days or less; grade 3 nausea responsive to antiemetics; grade 3 infection with normal ANC or grade 1 or 2 neutrophils; grade 3 diarrhea responsive to optimal use of antidiarrheal therapy.|DLTs were assessed during the first cycle of combination therapy (days 1-28).|The Phase I analysis sample includes the 12 patients who were enrolled into the Phase I portion of the study.||participants|||Number
795507|NCT00924352|Primary|Determination of the Maximum Tolerated Dose (MTD) of Ixabepilone When Given in Combination With Dasatinib (Phase I)|The MTD of ixabepilone (administered on Days 1, 8, and 15 of a 28-day cycle) when given in combination with dasatinib (taken daily, continuously) was determined using a standard 3 + 3 dose escalation cohort design. The total sample and the number of patients who receive each dose in this design depends on the frequency of dose limiting toxicities (DLT) at each dosage. The MTD was defined as the dose at which ≤ 1 of 6 patients experienced DLT, and above which ≥ 2 of 6 patients experienced DLT.|MTD was assessed during the first cycle of combination therapy (days 1-28).|The Phase I analysis sample includes the 12 patients who were enrolled into the Phase I portion of the study.||mg/m2|||Number
795508|NCT00924352|Primary|Determination of the Maximum Tolerated Dose (MTD) of Dasatinib When Given in Combination With Ixabepilone (Phase I)|The MTD of dasatinib (taken daily, continuously) when given in combination with ixabepilone (administered on Days 1, 8, and 15 of a 28-day cycle) was determined using a standard 3 + 3 dose escalation cohort design. The total sample and the number of patients who receive each dose in this design depends on the frequency of dose limiting toxicities (DLT) at each dosage. The MTD was defined as the dose at which ≤ 1 of 6 patients experienced DLT, and above which ≥ 2 of 6 patients experienced DLT.|MTD was assessed during the first cycle of combination therapy (days 1-28).|The Phase I analysis sample includes the 12 patients who were enrolled into the Phase I portion of the study.||mg daily|||Number
795509|NCT00924404|Secondary|Antibiotic Use|Number of antibiotic courses for infections during the study period|12 weeks||12/2020||||
795510|NCT00924404|Primary|SNOT-20|"Sinonasal outcome test is a 20 item quality of life questionnaire: Min-Max score range 0-100 The SNOT score for each patient was defined as the mean value of the response to the 20 items. The questionnaire is divided into 4 subsets, symptoms related to nose, symptoms of ear and face, sleep quality and psychological issues.
Symptoms arereported on 100 mm visual analog scales (VASs) where 0 mm represents no symptoms and 100 mm represent “as troublesome as possible”. The symptom severity is considered mild between 0 and 30, moderate from 30 to 70 and severe from 70- 100."|12 weeks|||units on a scale||Standard Deviation|Mean
795511|NCT00924443|Secondary|Duration of Complete Remission|Duration was calculated by Kaplan- Meier estimates|From 20 months up to 48 months|The analysis were performed on the primary analysis population, the Full Analysis Set population. Defined as the median duration of participants who achieved CR+CRi only||days||95% Confidence Interval|Median
795512|NCT00924443|Secondary|Overall Survival|Calculated by Kaplan-Meier estimates|From 20 months up to 48 months|The efficacy analyses were performed on the primary analysis population, the Full Analysis Set population, which consisted of all participants with a diagnosis of AML confirmed by the Investigator who received at least one dose (partial or complete) of clofarabine.||days||95% Confidence Interval|Median
795513|NCT00924443|Secondary|Duration of Overall Response|Duration was calculated by Kaplan-Meier estimates|From 20 months up to 48 months|The analysis were performed on the primary analysis population, the Full Analysis Set population. Defined as the median duration of overall response (CR+CRi+PR) in participants who achieved CR, CRi or PR only||days||95% Confidence Interval|Median
795514|NCT00924443|Secondary|Rate of Response (Complete, Complete With Incomplete Blood Count Recovery, Partial)|"Response was determined by assessment of morphology and blast count from bone marrow aspirates and peripheral blood performed prior to first dose and at the end of clofarabine treatment.
Response was determined at the end of each cycle of clofarabine, and assessed using the participant's best response to clofarabine treatment."|At month 20|The efficacy analyses were performed on the primary analysis population, the Full Analysis Set population, which consisted of all participants with a diagnosis of AML confirmed by the Investigator who received at least one dose (partial or complete) of clofarabine.||percent of participants||95% Confidence Interval|Number
795515|NCT00924443|Primary|Overall Response Rate (ORR)|"ORR rate was defined as the sum of the number of participants in the study population with complete remission (CR), complete remission with incomplete blood count recovery (CRi), or partial remission (PR) divided by the total number of participants in the study population.
ORR rate was determined by assessment of morphology and blast count from bone marrow aspirates and peripheral blood performed prior to first dose and at the end of clofarabine treatment. The ORR was determined at the end of each cycle of clofarabine, and assessed using the participant's best response to clofarabine treatment."|At month 20|The efficacy analysis was performed on the primary analysis population, the Full Analysis Set population, which consisted of all participants with a diagnosis of AML confirmed by the Investigator who received at least one dose (partial or complete) of clofarabine.||percentage of participants||95% Confidence Interval|Number
795516|NCT00924469|Primary|Dihydrotestosterone (DHT) Concentration in Prostate Tissue|The DHT is a potent androgenic metabolite of testosterone and the concentration of DHT was measured in prostate tissues after exposure to study treatments at Week 12.|Week 12|Intent-to-treat (ITT) population included all the participants who were randomly assigned to the study treatment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.||Picogram per milligram (pg/mg)||Standard Deviation|Mean
795517|NCT00924469|Secondary|Correlation Between Molecular and Protein Expression With Intracellular Androgen Levels and Pathologic Response to Study Treatment|Molecular and protein expression was correlated with intracellular androgen levels and pathologic response to study treatment.|Week 24|Resullts were not reported due to insufficient data in this outcome measure.|||||
795548|NCT00924638|Secondary|AF Detection Rate Within 12 Months|Percentage of subjects with AF detected within 12 months of follow-up|12 months|Intention-to-treat (ITT) population (all randomized subjects)||percentage of participants|||Number
796272|NCT00928408|Primary|Cinacalcet Dosing Frequency|Cinacalcet dosing frequency at Month 3|Month 3|Full Analysis Set - Participants with Observed Data||Participants|||Number
795518|NCT00924469|Secondary|Number of Participants With Tumor Expression of Androgen Receptor (AR) Regulated Genes at Week 24|Tumor expression of AR regulated genes determined by real-time polymerase chain reaction (RT PCR). PCR is an in vitro method for producing large amounts of specific deoxyribonucleic acid (DNA) or ribonucleic acid fragments of defined length and sequence from small amounts of short oligonucleotide flanking sequences (primers). RT PCR is a method used for detecting the amplified DNA products from the PCR as they accumulate instead of at the end of the reaction.|Week 24|Resullts were not reported due to insufficient data in this outcome measure.|||||
795519|NCT00924469|Secondary|Percentage of Participants With Pathologic Complete Response (CR)|Complete response is defined as a disappearance of all target lesions and was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criterion.|Week 24|ITT population included all the participants who were randomly assigned to the study treatment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.||Percentage of participants|||Number
795520|NCT00924469|Secondary|Percentage of Participants With Prostate-specific Antigen (PSA) Response|The PSA response was evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) criterion which is, percentage of participants with PSA less than or equal to 0.2 nanogram/milliliter at Weeks 12 and 24 after androgen deprivation.|Weeks 12 and 24|ITT population included all the participants who were randomly assigned to the study treatment.||Percentage of participants|||Number
795521|NCT00924469|Secondary|Serum Levels of Androgens|Serum concentrations of testosterone, DHT, androsterone, DHEA, DHEA-Sulfate, DHEA-Glucuronide and delta-4-androstenedione were measured at Weeks 12 and 24.|Week 12 and 24|"ITT population included all the participants who were randomly assigned to the study treatment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure and n signifies those participants who were evaluated for this measure at the specified time point."||Nanogram per deciliter (ng/dL)||Standard Deviation|Mean
795522|NCT00924469|Secondary|Androstenedione and Dehydroepiandrosterone (DHEA) Concentrations in Prostate Tissue|Androstenedione is a steroid (a group of polycyclic compounds closely related biochemically to terpenes, for example, cholesterol, numerous hormones), that is produced in the testis, ovary and the adrenal cortex, and depending on the tissue type, androstenedione can serve as a precursor to testosterone, estrone and estradiol. The DHEA is a major steroid produced by the adrenal cortex. It is also produced in small quantities in the testis and the ovary. Androstenedione and DHEA concentration was measured in prostate tissues at Week 12 and 24.|Week 12 and 24|"ITT population included all the participants who were randomly assigned to the study treatment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure and n signifies those participants who were evaluated for this measure at the specified time point."||Picogram per milligram (pg/mg)||Standard Deviation|Mean
795523|NCT00924469|Secondary|Testosterone and Dihydrotestosterone (DHT) Concentration in Prostate Tissue|Testosterone is a potent androgen (a hormone that promotes the development and maintenance of male characteristics) and major product secreted by cells in the testis and produced in the adrenal glands and by prostate cancers. Dihydrotestosterone (DHT) is a potent androgenic metabolite of testosterone. Testosterone and DHT concentration was measured in prostate tissues after exposure to study treatments at Week 24.|Week 24|ITT population included all the participants who were randomly assigned to the study treatment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.||Picogram per milligram (pg/mg)||Standard Deviation|Mean
795524|NCT00924469|Primary|Testosterone Concentration in Prostate Tissue|Testosterone is a potent androgen (a hormone that promotes the development and maintenance of male characteristics) and major product secreted by cells in the testis and produced in the adrenal glands and by prostate cancers. Abiraterone acetate affects sources of testosterone in the body (ie, adrendal gland and prostate tumor). Testosterone concentration was measured in prostate tissues after exposure to study treatments at Week 12.|Week 12|Intent-to-treat (ITT) population included all the participants who were randomly assigned to the study treatment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.||Picogram per milligram (pg/mg)||Standard Deviation|Mean
795525|NCT00924482|Primary|Comparison of ECOM Impedance and Thermodilution Cardiac Output Measurements|"Correlation measured via Linear regression between thermodilution and ECOM, included as r^2 coefficient.
Cardiac output measured by iced-thermodilution and impedance cardiography. Management of the patients done using (standard) thermodilution derived cardiac output measurements only. The ECOM endotracheal cardiac output measurements are for research purposes only and not used in the management of the patient.
ECOM Impedance cardiography measured in the ICU when routine thermodilution cardiac output measurements are made. Endotracheal impedance measurements (ECOM) continued until tracheal extubation. Correlation with thermodilution measurements stopped when either the endotracheal tube or the thermodilution catheter was removed (post op day 0 routinely)."|perioperative period|Results are for the final n=101 who had the approved clinical electronics and clinical tube; no changes in tube, algorithm or electronic design were made during this part of the study. Experimental electronics and version of the tube were used to test and finalize the design and algorithm during enrollment of the earlier patient group.||liters/min||Standard Deviation|Mean
795526|NCT00924482|Secondary|Safety of Device Measured by Number of Participants With Adverse Events|Patients were interviewed postoperatively for all complications and specifically for complications related to intubation and/or cardiac output measurements|perioperative period|||participants|||Number
795527|NCT00924508|Secondary|Number of Adverse Events Associated With Treatment||6 weeks|3 of 23 enrolled participants withdrew consent and did not provide data for analysis. Each participant had 3 lesions treated in the study, one by each of 3 study treatments.||Adverse events|||Number
795528|NCT00924508|Primary|Change in Disease Severity: Percent Change in Mean EASI Score|Percent change in mean EASI score week 0 to week 6: Each lesion was scored using a 12-point modified Eczema Area and Severity Index (EASI) at baseline and 2 weeks after the 4-week treatment period (week6). An experienced evaluator assessed each lesion on the severity of 4 domains, with higher scores indicating more severity: 1) intensity of redness (erythema), 2) thickness (induration, papulation, oedema), 3) scratching (excoriation) and 4) lichenification (lined skin) as as none (0), mild (1), moderate (2) and severe (3). Pictorial and descriptive instructions guided the evaluator in scoring the lesions based on visual appearance.|Baseline, 6 weeks|3 of 23 enrolled participants withdrew consent and did not provide data for analysis. Each participant had 3 lesions treated in the study, one by each of 3 study treatments.||percentage change|Participants|Full Range|Mean
795529|NCT00924560|Secondary|Number of Participants With Adverse Events (AEs)|"An adverse event was any untoward medical occurrence in a clinical investigation subject participating in the clinical study, and did not necessarily need to have a causal relationship with treatment or the clinical study. The relationship of each adverse event to study treatment or procedures, and the severity and seriousness of each adverse event was judged by the investigator, as described below.
A severe AE is defined as incapacitating, with inability to perform usual activities.
A serious adverse event is an adverse event occurring at any dose that resulted in any of the following outcomes or actions:
fatal or life-threatening;
required or prolonged inpatient hospitalization;
resulted in persistent or significant disability/incapacity;
congenital anomaly or birth defect;
important medical event."|12 months|The safety analysis set includes data from all randomly assigned participants who received at least 1 dose of study treatment and from all participants enrolled in the control group who had baseline BMD measures via DXA. One participant randomly assigned to 91-day LNG received 21-day LNG instead and is included in the 21-day LNG group for safety.||participants|||Number
795530|NCT00924560|Secondary|Change From Baseline in Serum Type I Collagen N-telopeptide||Baseline, Month 6 and Month 12|"Per protocol analysis set with Baseline data available; participants with available data at each time point are indicated by n."||nM bone collagen equivalents (BCE)||Standard Deviation|Mean
795531|NCT00924560|Secondary|Change From Baseline in Serum Procollagen 1 N-terminal Propeptide||Baseline, Month 6 and Month 12|"Per protocol analysis set with Baseline data available; participants with available data at each time point are indicated by n."||µg/L||Standard Deviation|Mean
795532|NCT00924560|Secondary|Change From Baseline in Serum Osteocalcin||Baseline, Month 6 and Month 12|"Per protocol analysis set with Baseline data available; participants with available data at each time point are indicated by n."||nmol/L||Standard Deviation|Mean
795533|NCT00924560|Secondary|Change From Baseline in Serum Deoxypyridinoline||Baseline, Month 6 and Month 12|"Per protocol analysis set with Baseline data available; participants with available data at each time point are indicated by n."||nmol/L||Standard Deviation|Mean
795534|NCT00924560|Secondary|Change From Baseline in Bone-specific Alkaline Phosphatase||Baseline, Month 6 and Month 12|"Per protocol analysis set with Baseline data available; participants with available data at each time point are indicated by n."||µg/L||Standard Deviation|Mean
795535|NCT00924560|Secondary|Change From Baseline in Total Body Bone Mineral Content (BMC)|Bone mineral content was measured by dual energy X-ray absorptiometry (DXA) scans and interpreted centrally by blinded, certified technologists.|Baseline, Month 6 and Month 12|"Per-protocol analysis set with Baseline total body DXA scans. Participants with available total body DXA scans at each time point are indicated by n."||g||Standard Error|Least Squares Mean
795536|NCT00924560|Secondary|Change From Baseline in Total Body Bone Mineral Density|Bone mineral density was measured by dual energy X-ray absorptiometry (DXA) scan. DXA scans were interpreted centrally by blinded, certified technologists.|Baseline, Month 6 and Month 12|"Per-protocol analysis set with Baseline total body DXA scans. Participants with available total body DXA scans at each time point are indicated by n."||g/cm^2||Standard Error|Least Squares Mean
795537|NCT00924560|Secondary|Change From Baseline in Proximal Femur Bone Mineral Content (BMC)|Bone mineral content was measured by dual energy X-ray absorptiometry (DXA) scans and interpreted centrally by blinded, certified technologists.|Baseline, Month 6 and Month 12|"Per-protocol analysis set with available Baseline proximal femur DXA scans; participants with available proximal femur DXA scans at each time point are indicated by n."||g||Standard Error|Least Squares Mean
795538|NCT00924560|Secondary|Change From Baseline in Proximal Femur Bone Mineral Density|Bone mineral density was measured by dual energy X-ray absorptiometry (DXA) scan. DXA scans were interpreted centrally by blinded, certified technologists.|Baseline, Month 6 and Month 12|"Per-protocol analysis set with available Baseline proximal femur DXA scans; participants with available proximal femur DXA scans at each time point are indicated by n."||g/cm^2||Standard Error|Least Squares Mean
795539|NCT00924560|Secondary|Change From Baseline in Lumbar Spine Bone Mineral Content (BMC)|Bone mineral content was measured by dual energy X-ray absorptiometry (DXA) scans and interpreted centrally by blinded, certified technologists.|Baseline, Month 6 and Month 12|Per-protocol analysis set||g||Standard Error|Least Squares Mean
795540|NCT00924560|Secondary|Change From Baseline in Lumbar Spine Bone Mineral Density|Bone mineral density was measured by dual energy X-ray absorptiometry (DXA) scan. DXA scans were interpreted centrally by blinded, certified technologists.|Baseline, Month 6 and Month 12|Per-protocol analysis set||g/cm^2||Standard Error|Least Squares Mean
795541|NCT00924560|Primary|Percent Change From Baseline to 12 Months in Lumbar Spine Bone Mineral Density (BMD)|"Bone mineral density was measured by dual energy X-ray absorptiometry (DXA) scan. DXA scans were interpreted centrally by blinded, certified technologists.
Percent change from Baseline was calculated as (BMD at Month 12 – BMD at Baseline)/BMD at Baseline * 100%."|Baseline and Month 12|Per-protocol analysis set, including all participants who received at least 1 dose of study treatment (does not apply to Control group), had both Baseline and one post-baseline assessment via DXA, and who completed all procedures at all scheduled study visits including the 12-month DXA scans, and did not have any major protocol violations.||percent change||Standard Error|Least Squares Mean
795542|NCT00924638|Secondary|Impact of Patient Assistant Use on AF Diagnosis|AF detection lag (days from AF occurrence to AF diagnosis) characterized by patient assistant (PA) use frequency|Follow-up closure|Number of subjects in the Continuous Monitoring arm who had AF detected by the Insertable Cardiac Monitor (ICM) during the course of the study||days from AF occurrence to AF diagnosis||Standard Deviation|Mean
795543|NCT00924638|Secondary|Clinical Disease Burden and Care Pathway|Incidence of cardiovascular (CV) or stroke/TIA related hospitalizations within 12 months|12 months|Intention-to-treat (ITT) population (all randomized subjects)||percentage of participants|||Number
795544|NCT00924638|Secondary|Health Outcome as Evaluated by EQ-5D Questionnaire|EQ-5D VAS (visual analog scale) quality of life score, which is a continuous measure of quality of life ranging from 0 (worst) to 100 (perfect health).|12 months|Number of subjects who reported EQ-5D VAS score at the 12 months visit||units on a scale of 0 to 100||Standard Deviation|Mean
795545|NCT00924638|Secondary|Use of Antiarrhythmic Drugs|Percentage of subjects who were using antiarrhythmic drugs at the 12 months follow-up visit|12 months|Number of subjects who completed the 12 months follow-up visit||percentage of participants|||Number
798354|NCT00939211|Secondary|Pulse, Average Effect Over 0 - 4 Hours Post-dose|Average pulse value|0, 30 min, 2 h, 4 h|||bpm||Standard Deviation|Mean
795549|NCT00924638|Primary|AF Detection Rate Within 6 Months|Percentage of subjects with AF detected within 6 months of follow-up|6 months|Intention-to-treat (ITT) population (all randomized subjects)||percentage of participants|||Number
795550|NCT00924651|Primary|Change of Cancer-related Fatigue as Assessed by the Brief Fatigue Inventory (BFI) Total Score at Day 41 (After Exercise Intervention) Minus BFI Total Score at Day 0 (Before Exercise Intervention)|"BFI has nine items. Three items ask patients to rate the severity of their fatigue at its “worst,” “usual,” and “now” during normal waking hours, with 0 being “no fatigue” and 10 being “fatigue as bad as you can imagine.” Six items assess the amount that fatigue has interfered with different aspects of the patient's life during the past 24 hours. The interference items include general activity, mood, walking ability, normal work (includes both work outside the home and housework), relations with other people, and enjoyment of life. The interference items are measured on a 0–10 scale, with 0 being “does not interfere” and 10 being “completely interferes.” BFI Total Score is the average of the nine items, ranging from 0 (no fatigue) to 10 (high fatigue).
The outcome measure is the change in the Brief Fatigue Inventory Total Score at day 41 (after exercise intervention) minus Brief Fatigue Inventory Total Score at day 0 (before exercise intervention)."|41 days: Day 0 (before intervention) Day 41 (post intervention)|Subjects completing both BFI at day 0 and day 41||units on a scale||Standard Deviation|Mean
795553|NCT00924781|Secondary|Change From Baseline in Hg Level at Week 12||12 weeks|Full analysis set; due to study termination participants in the MK2578 1mcg/350U QW and MK2578 1mcg/350U QM were not analyzed.||g/dL||Standard Deviation|Mean
795554|NCT00924781|Primary|Number of Participants With Confirmed, Treatment Emergent Antibodies to MK2578||12 weeks|Immunogenicity assays for antibodies to MK2578 were not performed due to early study termination.|||||
795555|NCT00924781|Primary|Number of Participants With Events of Death, MI, CVA, Peripheral Vascular Thromboses, Vascular Access Thrombosis, Congestive Heart Failure (CHF), Hypertension, Seizure, or Pure Red Cell Aplasia||12 weeks|||Participants|||Number
795556|NCT00924781|Primary|Number of Participants With Composite Events of Infusion Reactions||12 weeks|||Participants|||Number
795557|NCT00924781|Primary|Number of Participants With Composite Events of Transfusion-Related Adverse Experiences||12 weeks|||Participants|||Number
795558|NCT00924781|Primary|Number of Participants With Composite Events of Death, Myocardial Infarction (MI), and Cerebrovascular Accident (CVA)||12 weeks|||Participants|||Number
795559|NCT00924781|Primary|Change From Baseline in Hemoglobin (Hg) Level at Week 4||4 weeks|Full analysis set||g/dL||Standard Deviation|Mean
795560|NCT00924807|Secondary|Biochemical Disease-free Survival|"Data of zero (0) participants were analyzed due to lack of funding and prematurely terminating the study by sponsor. All subjects are following up in the clinic off the study."|after 9 months||||||
795561|NCT00924807|Primary|Determine the Safety and Maximally Tolerated Dose of Sorafenib Administered Concurrently With Radiotherapy in the Treatment of Intermediate- and High-risk Localized Prostate Cancer.|"Data of zero (0) participants were analyzed due to lack of funding and prematurely terminating the study by sponsor. All subjects are following up in the clinic off the study."|Day 29 and every 2 weeks|"Data of zero (0) participants were analyzed due to lack of funding and prematurely terminating the study by sponsor. All subjects are following up in the clinic off the study."|||||
795562|NCT00924833|Secondary|Mean 24 Hour/Daytime/Night-time Blood Pressure and Heart Rate||Time 1: sea level, baseline, no treatment. Time 2: sea level, after three weeks of allocated treatment. Time 3: within the first two days of high altitude exposure, under treatment.||12/2009||||
795563|NCT00924833|Secondary|Sitting Blood Pressure and Heart Rate||Time 1: sea level, baseline, no treatment. Time 2: sea level, after three weeks of allocated treatment. Time 3: within the first two days of high altitude exposure, under treatment.||12/2009||||
795564|NCT00924833|Secondary|Resting Energy Expenditure||Time 1: sea level, baseline, no treatment. Time 2: sea level, after three weeks of allocated treatment. Time 3: within the first two days of high altitude exposure, under treatment.||12/2009||||
795565|NCT00924833|Primary|Delta Peak Exercise Minute Ventilation Time 1 Versus Time 3.|"Difference in peak exercise minute ventilation between Time 1 and Time 3 (Time 3 - Time 1.
Minute ventilation = tidal volume (ml) multiplied by the respiratory rate (breaths/min)."|Time 1: sea level, baseline, no treatment. Time 3: within the first two days of high altitude exposure, under treatment.|||L/min||Standard Deviation|Mean
795566|NCT00924833|Secondary|Systolic Pulmonary Artery Pressure.||Time 1: sea level, baseline, no treatment. Time 2: sea level, after three weeks of allocated treatment. Time 3: within the first two days of high altitude exposure, under treatment.||12/2009||||
795567|NCT00924833|Secondary|Peak Exercise Oxygen Saturation|Oxygen saturation by pulse oxymetry at peak of exercise|Time 1: sea level, baseline, no treatment. Time 2: sea level, after three weeks of allocated treatment. Time 3: within the first two days of high altitude exposure, under treatment.||12/2009||||
795568|NCT00924833|Primary|Peak Exercise Minute Ventilation|Minute ventilation at peak of exercise. Minute ventilation = tidal volume (ml) multiplied by the respiratory rate (breaths/min)|Time 1: sea level, baseline, no treatment. Time 2: sea level, after three weeks of allocated treatment. Time 3: within the first two days of high altitude exposure, under treatment.|||L/min||Standard Deviation|Mean
811073|NCT01051778|Secondary|Minor and Major Bleeding||Duration of pregnancy and puerperium||||||
795569|NCT00924833|Primary|Delta Peak Exercise Oxygen Consumption Time 1 Versus Time 3|Difference in peak exercise oxygen consumption between Time 1 and Time 3 (Time 3 - Time 1)|Time 1: sea level, baseline, no treatment. Time 3: within the first two days of high altitude exposure, under treatment.|||ml/Kg/min||Standard Deviation|Mean
795570|NCT00924833|Primary|Peak Exercise Oxygen Consumption|Oxygen consumption at peak of exercise|Time 1: sea level, baseline, no treatment. Time 2: sea level, after three weeks of allocated treatment. Time 3: within the first two days of high altitude exposure, under treatment.|||ml/Kg/min||Standard Deviation|Mean
795571|NCT00924898|Secondary|Time to HIV RNA Suppression <50 Copies/mL|Number of days from ART initiation to HIV RNA suppression <50 copies/mL|Number of days from start of study treatment until HIV RNA suppression, assessed through week 96|||days||Full Range|Median
795572|NCT00924898|Secondary|Number of Participants With Baseline Genotypic Resistance to One or More Antiretroviral Drugs in the Study Treatment|Baseline genotypic resistance defined as presence of any surveillance drug resistance mutation to any drug in the study treatment listed by the World Health Organization|At enrollment|||Participants|||Count of Participants
795573|NCT00924898|Secondary|Number of Participants With Baseline Genotypic Resistance to Antiretroviral Medications|Prevalence of any of the surveillance drug resistance mutations associated with resistance to antiretroviral medications listed by the World Health Organization|At enrollment|||Participants|||Count of Participants
795574|NCT00924898|Secondary|Number of Participants With HIV RNA Suppression at Week 96|Number of participants wtih HIV RNA level <50 copies/mL at week 96|HIV RNA level at 96 weeks following enrollment|||Participants|||Count of Participants
795575|NCT00924898|Secondary|Number of Participants Without Virologic Failure at Week 48|HIV RNA level <50 copies/mL at week 48|HIV RNA level at week 48 following enrollment|||Participants|||Count of Participants
795576|NCT00924898|Primary|Number of Participants Without Virologic Failure at Week 24|Number of participants with a HIV RNA level <200 copies/mL at week 24|HIV RNA level prior to or at week 24 following enrollment|||Participants|||Count of Participants
795577|NCT00924950|Secondary|To Determine the Change in Modified PASI Scores Between Week 4 and Week 6 During the Follow-up Period. This is to Determine Whether There is Further Improvement of Psoriasis After the Cessation of Occlusion.||Between Week 4 and Week 6||||||
795578|NCT00924950|Primary|Difference in Change Between Baseline and Week 4 Modified Psoriasis Area Severity Index (PASI) Scores in Targeted Plaques Treated With Taclonex Under Occlusive Dressing Versus Taclonex Alone.|Modified psoriasis severity index measures erythema, induration, and scaling each measured from 0-4, with a maximum summed score of 12. A higher score means greater psoriasis severity and a lower score means lower psoriasis severity.|Between Baseline and Week 4|The number of participants was chosen by our budget restrictions||Units on a scale||95% Confidence Interval|Mean
795579|NCT00925015|Primary|Number of Participants With an Adverse Event (AE)|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR’s product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR’s product, is also an AE.|Approximately 4 weeks after last drug treatment (up to Day 293)|Participants treated with study medication.||Participants|||Number
795580|NCT00925015|Secondary|AUC0-24 of Irinotecan Following Administration of Cetuximab / Irinotecan Alone, or in Combination With 10 mg/kg Dalotuzumab|In Cycle 1 Irinotecan was administered with an intravenous infusion of 150 mg/m^2 once every other week on Days 1, 15, and 29. In the same Cycle 1 Dalotuzumab 10 mg/kg was administered on Days 22, 29 and 36; and Cetuximab was administered on Days 1, 8, 15, 22, 29 and 36. The AUC0-24 of plasma Irinotecan was determined alone on Day 15 and in combination with dalotuzumab on Day 29.|Cycle 1: Day 15 and Day 29 at predose, 1, 5, 8 and 24 h after completion of Irinotecan infusion|Participants from the Cetux/Irin - Dmab 10 mg/kg arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
795581|NCT00925015|Secondary|Vss of Irinotecan Following Administration of Cetuximab / Irinotecan Alone, or in Combination With 10 mg/kg Dalotuzumab|In Cycle 1 Irinotecan was administered with an intravenous infusion of 150 mg/m^2 once every other week on Days 1, 15, and 29. In the same Cycle 1 Dalotuzumab 10 mg/kg was administered on Days 22, 29 and 36; and Cetuximab was administered on Days 1, 8, 15, 22, 29 and 36. The Vss of plasma Irinotecan was determined alone on Day 15 and in combination with dalotuzumab on Day 29.|Cycle 1: Day 15 and Day 29 at predose, 1, 5, 8, 24, and 48 h after completion of Irinotecan infusion|Participants from the Cetux/Irin - Dmab 10 mg/kg arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.||L/m^2||Geometric Coefficient of Variation|Geometric Mean
795582|NCT00925015|Secondary|CL of Irinotecan Following Administration of Cetuximab / Irinotecan Alone, or in Combination With 10 mg/kg Dalotuzumab|In Cycle 1 Irinotecan was administered with an intravenous infusion of 150 mg/m^2 once every other week on Days 1, 15, and 29. In the same Cycle 1 Dalotuzumab 10 mg/kg was administered on Days 22, 29 and 36; and Cetuximab was administered on Days 1, 8, 15, 22, 29 and 36. The CL of plasma Irinotecan was determined alone on Day 15 and in combination with dalotuzumab on Day 29.|Cycle 1: Day 15 and Day 29 at predose, 1, 5, 8, 24, and 48 h after completion of Irinotecan infusion|Participants from the Cetux/Irin - Dmab 10 mg/kg arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.||L/h/m^2||Geometric Coefficient of Variation|Geometric Mean
795583|NCT00925015|Secondary|T1/2 of Irinotecan Following Administration of Cetuximab / Irinotecan Alone, or in Combination With 10 mg/kg Dalotuzumab|In Cycle 1 Irinotecan was administered with an intravenous infusion of 150 mg/m^2 once every other week on Days 1, 15, and 29. In the same Cycle 1 Dalotuzumab 10 mg/kg was administered on Days 22, 29 and 36; and Cetuximab was administered on Days 1, 8, 15, 22, 29 and 36. The T1/2 of plasma Irinotecan was determined alone on Day 15 and in combination with dalotuzumab on Day 29..|Cycle 1: Day 15 and Day 29 at predose, 1, 5, 8, 24, and 48 h after completion of Irinotecan infusion|Participants from the Cetux/Irin - Dmab 10 mg/kg arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.||h||Geometric Coefficient of Variation|Geometric Mean
812449|NCT01070784|Primary|ECG Variables - QT Interval|Change from baseline|Baseline and 52 week after|||ms||Standard Deviation|Mean
795584|NCT00925015|Secondary|Cmax of Irinotecan Following Administration of Cetuximab / Irinotecan Alone, or in Combination With 10 mg/kg Dalotuzumab|In Cycle 1 Irinotecan was administered with an intravenous infusion of 150 mg/m^2 once every other week on Days 1, 15, and 29. In the same Cycle 1 Dalotuzumab 10 mg/kg was administered on Days 22, 29 and 36; and Cetuximab was administered on Days 1, 8, 15, 22, 29 and 36. The Cmax of plasma Irinotecan was determined alone on Day 15 and in combination with dalotuzumab on Day 29.|Cycle 1: Day 15 and Day 29 at predose, 1, 5, 8, 24, and 48 h after completion of Irinotecan infusion|Participants from the Cetux/Irin - Dmab 10 mg/kg arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
795585|NCT00925015|Secondary|Tmax of Irinotecan Following Administration of Cetuximab / Irinotecan Alone, or in Combination With 10 mg/kg Dalotuzumab|In Cycle 1 Irinotecan was administered with an intravenous infusion of 150 mg/m^2 once every other week on Days 1, 15, and 29. In the same Cycle 1 Dalotuzumab 10 mg/kg was administered on Days 22, 29 and 36; and Cetuximab was administered on Days 1, 8, 15, 22, 29 and 36. The Tmax of plasma Irinotecan was determined alone on Day 15 and in combination with dalotuzumab on Day 29.|Cycle 1: Day 15 and Day 29 at predose, 1, 5, 8, 24, and 48 h after completion of Irinotecan infusion|Participants from the Cetux/Irin - Dmab 10 mg/kg arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.||h||Full Range|Median
795586|NCT00925015|Secondary|AUC0-168 of Cetuximab Following Administration of Cetuximab / Irinotecan Alone, or in Combination With 10 mg/kg Dalotuzumab|In Cycle 1 Cetuximab was administered with an initial intravenous infusion of 400 mg/m^2 on Day 8, followed by subsequent once weekly intravenous infusions of 250 mg/m^2 on Days 15, 22, 29 and 36. In the same Cycle 1 Dalotuzumab 10 mg/kg was administered on Days 22, 29 and 36; and Irinotecan was administered on Days 1, 22, and 29. The AUC0-168 of plasma Cetuximab was determined alone on Day 15 and in combination with dalotuzumab on Day 29.|Cycle 1: Day 15 and Day 29 at predose, 2, 5, 8, 24, 48, 96 and 168 h after initiation of cetuximab infusion|Participants from the Cetux/Irin - Dmab 10 mg/kg arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.||mg*h/mL||Geometric Coefficient of Variation|Geometric Mean
795587|NCT00925015|Secondary|AUC0-24 of Cetuximab Following Administration of Cetuximab / Irinotecan Alone, or in Combination With 10 mg/kg Dalotuzumab|In Cycle 1 Cetuximab was administered with an initial intravenous infusion of 400 mg/m^2 on Day 8, followed by subsequent once weekly intravenous infusions of 250 mg/m^2 on Days 15, 22, 29 and 36. In the same Cycle 1 Dalotuzumab 10 mg/kg was administered on Days 22, 29 and 36; and Irinotecan was administered on Days 1, 22, and 29. The AUC0-24 of plasma Cetuximab was determined alone on Day 15 and in combination with dalotuzumab on Day 29.|Cycle 1: Day 15 and Day 29 at predose, 2, 5, 8 and 24 h after initiation of cetuximab infusion|Participants from the Cetux/Irin - Dmab 10 mg/kg arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.||mg*h/mL||Geometric Coefficient of Variation|Geometric Mean
795588|NCT00925015|Secondary|Vss of Cetuximab Following Administration of Cetuximab / Irinotecan Alone, or in Combination With 10 mg/kg Dalotuzumab|In Cycle 1 Cetuximab was administered with an initial intravenous infusion of 400 mg/m^2 on Day 8, followed by subsequent once weekly intravenous infusions of 250 mg/m^2 on Days 15, 22, 29 and 36. In the same Cycle 1 Dalotuzumab 10 mg/kg was administered on Days 22, 29 and 36; and Irinotecan was administered on Days 1, 22, and 29. The Vss of plasma Cetuximab was determined alone on Day 15 and in combination with dalotuzumab on Day 29.|Cycle 1: Day 15 and Day 29 at predose, 2, 5, 8, 24, 48, 96 and 168 h after initiation of cetuximab infusion|Participants from the Cetux/Irin - Dmab 10 mg/kg arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.||L/m^2||Geometric Coefficient of Variation|Geometric Mean
795589|NCT00925015|Secondary|CL of Cetuximab Following Administration of Cetuximab / Irinotecan Alone, or in Combination With 10 mg/kg Dalotuzumab|In Cycle 1 Cetuximab was administered with an initial intravenous infusion of 400 mg/m^2 on Day 8, followed by subsequent once weekly intravenous infusions of 250 mg/m^2 on Days 15, 22, 29 and 36. In the same Cycle 1 Dalotuzumab 10 mg/kg was administered on Days 22, 29 and 36; and Irinotecan was administered on Days 1, 22, and 29. The CL of plasma Cetuximab was determined alone on Day 15 and in combination with dalotuzumab on Day 29.|Cycle 1: Day 15 and Day 29 at predose, 2, 5, 8, 24, 48, 96 and 168 h after initiation of cetuximab infusion|Participants from the Cetux/Irin - Dmab 10 mg/kg arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.||mL/h/m^2||Geometric Coefficient of Variation|Geometric Mean
795590|NCT00925015|Secondary|T1/2 of Cetuximab Following Administration of Cetuximab / Irinotecan Alone, or in Combination With 10 mg/kg Dalotuzumab|In Cycle 1 Cetuximab was administered with an initial intravenous infusion of 400 mg/m^2 on Day 8, followed by subsequent once weekly intravenous infusions of 250 mg/m^2 on Days 15, 22, 29 and 36. In the same Cycle 1 Dalotuzumab 10 mg/kg was administered on Days 22, 29 and 36; and Irinotecan was administered on Days 1, 22, and 29. The T1/2 of plasma Cetuximab was determined alone on Day 15 and in combination with dalotuzumab on Day 29.|Cycle 1: Day 15 and Day 29 at predose, 2, 5, 8, 24, 48, 96 and 168 h after initiation of cetuximab infusion|Participants from the Cetux/Irin - Dmab 10 mg/kg arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.||h||Geometric Coefficient of Variation|Geometric Mean
795591|NCT00925015|Secondary|Cmax of Cetuximab Following Administration of Cetuximab / Irinotecan Alone, or in Combination With 10 mg/kg Dalotuzumab|In Cycle 1 Cetuximab was administered with an initial intravenous infusion of 400 mg/m^2 on Day 8, followed by subsequent once weekly intravenous infusions of 250 mg/m^2 on Days 15, 22, 29 and 36. In the same Cycle 1 Dalotuzumab 10 mg/kg was administered on Days 22, 29 and 36; and Irinotecan was administered on Days 1, 22, and 29. The Cmax of plasma Cetuximab was determined alone on Day 15 and in combination with dalotuzumab on Day 29.|Cycle 1: Day 15 and Day 29 at predose, 2, 5, 8, 24, 48, 96 and 168 h after initiation of cetuximab infusion|Participants from the Cetux/Irin - Dmab 10 mg/kg arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
815822|NCT01102374|Secondary|Number of Lower Respiratory Infections||12 months|||events|||Number
795592|NCT00925015|Secondary|Tmax of Cetuximab Following Administration of Cetuximab / Irinotecan Alone, or in Combination With 10 mg/kg Dalotuzumab|In Cycle 1 Cetuximab was administered with an initial intravenous infusion of 400 mg/m^2 on Day 8, followed by subsequent once weekly intravenous infusions of 250 mg/m^2 on Days 15, 22, 29 and 36. In the same Cycle 1 Dalotuzumab 10 mg/kg was administered on Days 22, 29 and 36; and Irinotecan was administered on Days 1, 22, and 29. The Tmax of plasma Cetuximab was determined alone on Day 15 and in combination with dalotuzumab on Day 29.|Cycle 1: Day 15 and Day 29 at predose, 2, 5, 8, 24, 48, 96 and 168 h after initiation of cetuximab infusion|Participants from the Cetux/Irin - Dmab 10 mg/kg arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.||h||Full Range|Median
795593|NCT00925015|Secondary|Area Under the Concentration-time Curve From 0-168 Hours Post-dose (AUC0-168) of Dalotuzumab Following Administration of 10 mg/kg Dalotuzumab Alone or in Combination With Cetuximab / Irinotecan|In Cycle 1 Dalotuzumab was administered on Days 1 and 22 as an intravenous infusion at 10 mg/kg. In the same Cycle 1 Cetuximab was administered on Days 8, 15, 22 and 29; and Irinotecan was administered on Days 8 and 22. The AUC0-168 of plasma Dalotuzumab alone was determined on Day 1, and in combination with cetuximab/irinotecan on Day 22.|Cycle 1: Day 1 and Day 22 at predose, 0.5 h after start of infusion, end of infusion, 5, 8, 24, 30, 48, 96 and 168 h after initiation of dalotuzumab infusion|Participants from the Dmab 10 mg/kg - Cetux/Irin (DDI) arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.||mg*h/mL||Geometric Coefficient of Variation|Geometric Mean
795594|NCT00925015|Secondary|Area Under the Concentration-time Curve From 0-24 Hours Post-dose (AUC0-24) of Dalotuzumab Following Administration of 10 mg/kg Dalotuzumab Alone or in Combination With Cetuximab / Irinotecan|In Cycle 1 Dalotuzumab was administered on Days 1 and 22 as an intravenous infusion at 10 mg/kg. In the same Cycle 1 Cetuximab was administered on Days 8, 15, 22 and 29; and Irinotecan was administered on Days 8 and 22. The AUC0-24 of plasma Dalotuzumab alone was determined on Day 1, and in combination with cetuximab/irinotecan on Day 22.|Cycle 1: Day 1 and Day 22 at predose, 0.5 h after start of infusion, end of infusion, 5, 8 and 24 h after initiation of dalotuzumab infusion|Participants from the Dmab 10 mg/kg - Cetux/Irin (DDI) arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.||mg*h/mL||Geometric Coefficient of Variation|Geometric Mean
795595|NCT00925015|Secondary|Steady-state Volume of Distribution (Vss) of Dalotuzumab Following Administration of 10 mg/kg Dalotuzumab Alone or in Combination With Cetuximab / Irinotecan|In Cycle 1 Dalotuzumab was administered on Days 1 and 22 as an intravenous infusion at 10 mg/kg. In the same Cycle 1 Cetuximab was administered on Days 8, 15, 22 and 29; and Irinotecan was administered on Days 8 and 22. The Vss of plasma Dalotuzumab alone was determined on Day 1, and in combination with cetuximab/irinotecan on Day 22.|Cycle 1: Day 1 and Day 22 at predose, 0.5 h after start of infusion, end of infusion, 5, 8, 24, 30, 48, 96 and 168 h after initiation of dalotuzumab infusion|Participants from the Dmab 10 mg/kg - Cetux/Irin (DDI) arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.||L/kg||Geometric Coefficient of Variation|Geometric Mean
795596|NCT00925015|Secondary|Clearance From Plasma (CL) of Dalotuzumab Following Administration of 10 mg/kg Dalotuzumab Alone or in Combination With Cetuximab / Irinotecan|In Cycle 1 Dalotuzumab was administered on Days 1 and 22 as an intravenous infusion at 10 mg/kg. In the same Cycle 1 Cetuximab was administered on Days 8, 15, 22 and 29; and Irinotecan was administered on Days 8 and 22. The CL of plasma Dalotuzumab alone was determined on Day 1, and in combination with cetuximab/irinotecan on Day 22.|Cycle 1: Day 1 and Day 22 at predose, 0.5 h after start of infusion, end of infusion, 5, 8, 24, 30, 48, 96 and 168 h after initiation of dalotuzumab infusion|Participants from the Dmab 10 mg/kg - Cetux/Irin (DDI) arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.||mL/min/kg||Geometric Coefficient of Variation|Geometric Mean
795597|NCT00925015|Secondary|Apparent Terminal Half-life (T1/2) of Dalotuzumab Following Administration of 10 mg/kg Dalotuzumab Alone or in Combination With Cetuximab / Irinotecan|In Cycle 1 Dalotuzumab was administered on Days 1 and 22 as an intravenous infusion at 10 mg/kg. In the same Cycle 1 Cetuximab was administered on Days 8, 15, 22 and 29; and Irinotecan was administered on Days 8 and 22. The T1/2 of plasma Dalotuzumab alone was determined on Day 1, and in combination with cetuximab/irinotecan on Day 22.|Cycle 1: Day 1 and Day 22 at predose, 0.5 h after start of infusion, end of infusion, 5, 8, 24, 30, 48, 96 and 168 h after initiation of dalotuzumab infusion|Participants from the Dmab 10 mg/kg - Cetux/Irin (DDI) arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.||h||Geometric Coefficient of Variation|Geometric Mean
795598|NCT00925015|Secondary|Maximum Concentration (Cmax) of Dalotuzumab Following Administration of 10 mg/kg Dalotuzumab Alone or in Combination With Cetuximab / Irinotecan|In Cycle 1 Dalotuzumab was administered on Days 1 and 22 as an intravenous infusion at 10 mg/kg. In the same Cycle 1 Cetuximab was administered on Days 8, 15, 22 and 29; and Irinotecan was administered on Days 8 and 22. The Cmax of plasma Dalotuzumab alone was determined on Day 1, and in combination with cetuximab/irinotecan on Day 22.|Cycle 1: Day 1 and Day 22 at predose, 0.5 h after start of infusion, end of infusion, 5, 8, 24, 30, 48, 96 and 168 h after initiation of dalotuzumab infusion|Participants from the Dmab 10 mg/kg - Cetux/Irin (DDI) arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
795599|NCT00925015|Secondary|Concentration at the End of Infusion (Ceoi) of Dalotuzumab Following Administration of 10 mg/kg Dalotuzumab Alone or in Combination With Cetuximab / Irinotecan|In Cycle 1 Dalotuzumab was administered on Days 1 and 22 as an intravenous infusion at 10 mg/kg. In the same Cycle 1 Cetuximab was administered on Days 8, 15, 22 and 29; and Irinotecan was administered on Days 8 and 22. The Ceoi of plasma Dalotuzumab alone was determined on Day 1, and in combination with cetuximab/irinotecan on Day 22.|Cycle 1: Day 1 and Day 22 at predose, 0.5 h after start of infusion, end of infusion, 5, 8, 24, 30, 48, 96 and 168 h after initiation of dalotuzumab infusion|Participants from the Dmab 10 mg/kg - Cetux/Irin (DDI) arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
795600|NCT00925015|Secondary|Time to Maximum Concentration (Tmax) of Dalotuzumab Following Administration of 10 mg/kg Dalotuzumab Alone in or in Combination With Cetuximab / Irinotecan|In Cycle 1 Dalotuzumab was administered on Days 1 and 22 as an intravenous infusion at 10 mg/kg. In the same Cycle 1 Cetuximab was administered on Days 8, 15, 22 and 29; and Irinotecan was administered on Days 8 and 22. The Tmax of plasma Dalotuzumab alone was determined on Day 1, and in combination with cetuximab/irinotecan on Day 22.|Cycle 1: Day 1 and Day 22 at predose, 0.5 h after start of infusion, end of infusion, 5, 8, 24, 30, 48, 96 and 168 h after initiation of dalotuzumab infusion|Participants from the Dmab 10 mg/kg - Cetux/Irin (DDI) arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.||h||Full Range|Median
795601|NCT00925015|Secondary|Number of Participants With Human Anti-Human Antibody (HAHA)|Sera were collected from participants prior to administration of the first dose of study drug, every 6 weeks during the study period, then 4 weeks, 8 weeks and 12 weeks post-treatment. A sandwich format enzyme-linked immunosorbent assay (ELISA) was used to detect the presence of HAHA in serum.|Up to 12 weeks after the last administration of dalotuzumab (up to 349 days)|All treated participants, excluding those without measurable data.||Participants|||Number
795602|NCT00925015|Primary|Number of Dose-limiting Toxicities (DLTs)|To be declared a DLT an adverse experience had a causality related to study therapy. DLTs could be adverse experiences possibly, probably, or definitely related to study therapy by the Investigator, and included the following : Grade 4 neutropenia lasting >= 5 days; Grade 3 or 4 neutropenia with fever >38.5°C; Grade 4 thrombocytopenia; Grade 3 or Grade 4 non-hematologic toxicity, except inadequately treated diarrhea, nausea and vomiting, rash, hyperglycemia, and transient abnormality of electrolytes. Anemia, infusion reactions, hypersensitivity reactions, and adverse experiences not-related to study therapy did not qualify as DLTs.|Four weeks of Cycle 1 treatment (up to 28 days)|Participants treated with study medication. The Dmab 10 mg/kg - Cetux/Irin arm was not evaluated. In the Cetux/Irin - Dmab 10 mg/kg (DDI) arm two participants were not analyzed because one had febrile neutropenia (Grade 3) before the first treatment, and the second had a skin toxicity (Grade 3) before the DLT evaluation period.||DLT|||Number
795603|NCT00925132|Secondary|Phase 2 - Number of Participants With Disease Progression|Number of participants who died or had disease progression|5 years|Number patients who received study drug in Phase II portion of trial||Participants|||Count of Participants
795604|NCT00925132|Primary|Phase 2 -Number of Patients With a Decrease in Tumor Size Using RECIST and CHOI's Criteria|"Tumor response rate was assessed using RECIST criteria in which a complete response was the disappearance of all target lesions; Partial response was a 30% decrease in the sum of the longest dimension (LD) of target lesions, relative to baseline measurement; Progressive disease was an increase of 20% or more in the sum of the LD of target lesions; and Stable disease was a decrease in tumor size of less than 30% or increase of less than 20%.
Tumor response rate was also assessed using CHOI's criteria in which a response was a 10% decrease in tumor size or a 15% decrease in tumor density on contrast-enhanced computed tomography scan.
Tumor response rates were assessed in order to determine effectiveness of the treatment regimen which was defined by the response rate of at least 30% as measured by either the RECIST or Choi’s criteria, and ineffective if the rate is less than 15% on both."|12 weeks (2 cycles)|Number of patients evaluable for tumor response assessment following 2 cycles of treatment||Participants|||Count of Participants
795605|NCT00925132|Primary|Phase I - Number of Participants With Dose Limiting Toxicities (DLTs) at a Given Dose Level|"A DLT was any Grade 4 toxicity for neutrophils or platelets for ≥ 7 days, Grade 3 toxicity for neutrophils for ≥ 21 days, any Grade 3 solid organ toxicity not explainable by another cause (e.g. neurotoxicity, GI toxicity), metabolic/laboratory toxicity (≥10 x ULN AST) for ≥ 14 days, any Grade 4 infection or QTcF> 500msec EKG. DLTs were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 3.0.
All adverse events were collected and graded to determine DLTs as assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 3.0. DLTs were assessed to determine the recommended Decitabine and Panobinostat dose for the Phase II portion of the trial."|6 weeks (one full cycle)|Number of patients within the 4 dosing cohorts evaluable for DLTs following administration of one full cycle||Participants|||Count of Participants
795606|NCT00925288|Secondary|Identify Barriers to Acceptance of HPV Vaccine Among Female Sex Workers|Listed doubts about the HPV vaccine. Participants were asked if they had any doubts about the vaccine prior to learning about it from the health professional. Herein we present the total number of participants who reported doubts by study arm.|Month 0|All participants who listed doubts about the vaccine are counted here.||participants|||Number
795607|NCT00925288|Secondary|Prevalence of Infection With HPV Subtypes (6,11,16,18) Among Female Sex Workers|Type specific prevalence of HPV6,11,16,18 among study participants, calculated using Linear Array testing.|Baseline|All participants were included in the analysis for baseline HPV DNA prevalence||participants|||Number
795608|NCT00925288|Primary|Proportion of Female Sex Workers Who Complete the Three Dose (0, 2, 6 Month) HPV Schedule in a Timely Manner Compared to the Modified (0, 3, 6 Month) Schedule.|Completion of 3 doses of HPV4 vaccine was measured at 6 months for women receiving the vaccine in 0,2,6 month regimen or the modified 0,3,6 month regimen. Completion was measured as receiving dose 3 of the vaccine during the study.|6 months|All participants were included||participants|||Number
795609|NCT00925288|Primary|Antibody Response to HPV Vaccine for HPV 6,11,16,18.|We measured anitbody response to HPV vaccine for HPV subtypes 6,11,16, and 18. This was compared by study arm, namely the regular and modified vaccination schedules.|Month 7|All participants who returned for the final blood draw considered in the final antibody analysis. The analysis applies to antibody levels after vaccination for HPV6, HPV11, HPV16, and HPV18. This is done for each study arm, namely the regular schedule and the modified schedule.||Milli Merck Units||95% Confidence Interval|Geometric Mean
795610|NCT00925353|Secondary|Frequencies of Moderate, Severe, or Life-threatening Side Effects|Percentages of study subjects exhibiting moderate, severe, or life-threatening signs and symptoms at each of the eight time measurements|Prior to gel application and at 30 min, 60 min and 2, 3, 4, 6. and 8 hours after||||||
795637|NCT00925587|Secondary|Ratio of Darbepoetin Alfa Dose to Baseline at Week 19|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 19|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||ratio||95% Confidence Interval|Geometric Mean
795611|NCT00925353|Secondary|Variation of Heart Rate (Bpm), Respiratory Rate (Respirations Per Minute, Rpm), Systolic Blood Pressure (mm Hg), and Diastolic Blood Pressure (mm Hg) Over Time.|Variation of heart rate (bpm), respiratory rate (respirations per minute, rpm), systolic blood pressure (mm Hg), and diastolic blood pressure (mm Hg) over time was assessed using generalized linear mixed models with time modeled as a fixed effect and study subject modeled as a random effect.|Prior to gel application and at 30 min, 60 min and 2, 3, 4, 6. and 8 hours after||||||
795612|NCT00925353|Secondary|EKG Changes|The PR interval (msec), QRS duration (msec), and QTc interval (msec) were compared between the baseline and subsequent EKG using paired t-tests.|Prior to gel application and 3 hours after||||||
795613|NCT00925353|Primary|Pharmacokinetic Parameters Based on Plasma Concentration of Lidocaine and MEGX in Nanograms/Milliliter.|Plasma concentration of lidocaine and MEGX in nanograms/milliliter were measured prior to one-time application of 4% lidocaine gel on the skin of the breasts and chest wall as recommended for use as as pre-medication to reduce discomfort during screening mammography, and at 30 minutes, 60 minutes, and 2, 3, 4, 6, and 8 hours. Due to the high frequency of nondetectable values, pharmacokinetic parameters could not be estimated. Measurements at all time points were grouped together to select a median.|Prior to gel application, and at 30 min, 60 min, and 2, 3, 4, 6, and 8 hours after|Plasma lidocaine and MEGX levels were measured prior to lidociane gel application, and at 30 min, 60, min, and 2, 3, 4, 6, and 8 hours after on 10 subjects (total of 80 lidocaine levels and 80 MEGX levels). Minimum level of detection for lidocaine and MEGX was 200 ng/mL.||nanograms/mililiter|Participants|Full Range|Median
795614|NCT00925522|Secondary|Chronic Success is Defined at 6 Months Following the RF Ablation Procedure as no Recurrence of Clinically Relevant VT(s) That Were Targeted at Ablation.|Summarized as the number of subjects with recurrence of clinically relevant VT(s) that were targeted at ablation at 6 months following the RF ablation procedure|6 months||08/2017||||
795615|NCT00925522|Primary|Acute Success is Achieved When All Clinically Relevant VT Substrates (Spontaneous and Induced VT Episodes) Are Terminated and no Longer Inducible Upon Hospital Discharge (i.e., Last Study Ablation Procedure Prior to Hospital Discharge).|Summarized as number of subjects with clinically relevant VT substrates (spontaneous and induced VT episodes) that are terminated and no longer inducible upon hospital discharge - from the last study ablation procedure prior to hospital discharge.|Hospital Discharge||08/2017||||
795616|NCT00925522|Primary|Primary Safety is Defined as the Incidence of Intra-procedural, Acute or Sub-chronic, Serious Cardiac Adverse Events, up to 7 Days Post-procedure.||7 days|||participants|||Number
795617|NCT00925548|Secondary|Serum Carcinoma Antigen (CA) 15-3 Levels|CA 15-3 is a serum marker for breast cancer which is a possible measure for immune response.|Baseline, Week 5, 9, 20, 32, 44 and end of trial visit|Data were not analyzed as the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25)|||||
795618|NCT00925548|Secondary|Number of Participant Utilizing Healthcare Resources|Healthcare Resource Utilization (HRU) parameters included direct medical resources (e.g., nonscheduled procedures, unplanned hospitalization, outpatient visits), nonmedical resources (e.g., travel, paid and unpaid assistance), and occupational resources (e.g., occupational changes and concerns).|Randomization up to end of trial visit|Data were not analyzed as the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25)|||||
795619|NCT00925548|Secondary|European Questionnaire-5 Dimensions (EQ-5D) Questionnaire|EQ-5D questionnaire is a measure of health status that provides a simple descriptive profile and a single index value. The optional part of the questionnaire was not applied. EQ-5D defines health in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 5 items are combined to generate health profiles. These profiles were to be converted to a continuous single index score using a one to one matching. The lowest possible score is -0.59 and the highest is 1.00. Higher scores on the EQ-5D represent a better quality of life (QoL) and lower scores on the EQ-5D represent a worst QoL.|Baseline, Week 9, 20, 32, 44 and end of trial visit|Data were not analyzed as the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25)|||||
795620|NCT00925548|Secondary|Functional Assessment of Cancer Therapy-Breast (FACT-B) Questionnaire|FACT-B questionnaire consists of 36 questions; 7 in physical well-being (PWB); 7 in social well-being (SWB); 6 in emotional well-being (EWB); 7 in functional well-being (FWB); 9 in breast cancer subscale (BCS). Trial outcome Index (TOI) was calculated by the sum of the physical well-being (PWB), functional well-being (FWB), and breast cancer scale (BCS) subscales of FACT-B. Total score of subscores or TOI is calculated from each score of question. Higher score means better and lower score means worthier. Score range; 0-28 in PWB; 0-28 in SWB; 0-24 in EWB; 0-28 in FWB; 0-36 in BCS; 0-92 in TOI.|Baseline, Week 9, 20, 32, 44 and end of trial visit|Data were not analyzed as the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25)|||||
795621|NCT00925548|Secondary|Time to Chemotherapy|Time to chemotherapy is defined as the time from date of randomization to the start date of chemotherapy.|Time from randomization to start of chemotherapy, reported between day of first participant randomized i.e. 30 Sep 2009, until end of trial i.e. 27 Aug 2010|Data were not analyzed as the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25)|||||
795622|NCT00925548|Secondary|Time to Progression (TTP)|TTP is defined as the time from date of randomization to the date of radiological diagnosis of PD (censoring for death without progression).|Time from randomization to PD, reported between day of first participant randomized i.e. 30 Sep 2009, until end of trial i.e. 27 Aug 2010|Data were not collected as no independent read took place, due to low numbers: the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25).|||||
795623|NCT00925548|Secondary|Percentage of Participants With Clinical Benefit|Clinical Benefit is defined as having achieved at least disease stabilization; that is participants with confirmed CR, PR, or stable disease (SD,) lasting for at least 22 weeks.|Randomization until the date of first documented progression assessed up to end of trial i.e. 27 Aug 2010|Data were not analyzed as the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25)|||||
795870|NCT00919126|Secondary|Haematology - Erythrocytes (Tera/L)|Erythrocytes (Tera/L) obtained from blood samples collected at baseline and in the morning following surgery.|1 Postoperative Day.|The analysis was done in the ITT Data Set (Randomised Patients).||Tera/L||Standard Deviation|Mean
795624|NCT00925548|Secondary|Duration of Response|Duration of response is defined as the time from the first assessment of CR or PR until the date of the first occurrence of PD, or until the date of death.|Time from first assessment of CR or PR until PD, death or last tumor assessment, reported between day of first participant randomized i.e. 30 Sep 2009, until end of trial i.e. 27 Aug 2010|Data were not analyzed as the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25)|||||
795625|NCT00925548|Secondary|Percentage of Participants With Objective Tumor Response|Percentage of participants with objective tumor response was to be reported. An objective response (OR) was defined as a participant having a best overall response of either confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors Version 1.0 (RECIST 1.0) as assessed by independent radiological review.|Randomization until the date of first documented progression, until end of trial i.e. 27 Aug 2010|Data were not analyzed as the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25)|||||
795626|NCT00925548|Secondary|Overall Survival (OS) Time|OS time was defined as the time from randomization to death. Participants without event were to be censored at the last date known to be alive or at the clinical cut-off date, whichever was earlier.|Time from randomization to death or last day known to be alive reported between day of first participant randomized i.e. 30 Sep 2009, until end of trial i.e. 27 Aug 2010|Data were not analyzed as the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25)|||||
795627|NCT00925548|Primary|Progression-Free Survival (PFS)|PFS was defined as the duration from randomization to first observation of progressive disease (PD) as confirmed by the independent radiological review or death.|Time from randomization to disease progression, death or last tumor assessment, reported between day of first participant randomized i.e. 30 Sep 2009, until end of trial i.e. 27 Aug 2010|Data were not collected as no independent read took place, due to low numbers: the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25).|||||
795628|NCT00925587|Secondary|Ratio of Darbepoetin Alfa Dose to Baseline at the Evalaution Period (Average of Weeks 29-33)|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Evaluation Period|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||ratio||95% Confidence Interval|Geometric Mean
795629|NCT00925587|Secondary|Time to First Achievement of a Hb ≥10.0 g/dL and a ≥1.0 g/dL Increase From Baseline (Weeks 1-33)||Weeks 1-33|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||Weeks||Inter-Quartile Range|Median
795630|NCT00925587|Secondary|Dose of Darbepoetin Alfa at the First Achievement of a Hb ≥10.0 g/dL and a ≥1.0 g/dL Increase From Baseline (Weeks 1-33)|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Weeks 1-33|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||µg/wk||95% Confidence Interval|Geometric Mean
795631|NCT00925587|Secondary|Ratio of Darbepoetin Alfa Dose to Baseline at Week 31|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 31|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||ratio||95% Confidence Interval|Geometric Mean
795632|NCT00925587|Secondary|Ratio of Darbepoetin Alfa Dose to Baseline at Week 29|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 29|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||ratio||95% Confidence Interval|Geometric Mean
795633|NCT00925587|Secondary|Ratio of Darbepoetin Alfa Dose to Baseline at Week 27|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 27|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||ratio||95% Confidence Interval|Geometric Mean
795634|NCT00925587|Secondary|Ratio of Darbepoetin Alfa Dose to Baseline at Week 25|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 25|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||ratio||95% Confidence Interval|Geometric Mean
795635|NCT00925587|Secondary|Ratio of Darbepoetin Alfa Dose to Baseline at Week 23|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 23|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||ratio||95% Confidence Interval|Geometric Mean
795636|NCT00925587|Secondary|Ratio of Darbepoetin Alfa Dose to Baseline at Week 21|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 21|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||ratio||95% Confidence Interval|Geometric Mean
796273|NCT00928408|Primary|Cinacalcet Dosing Frequency|Cinacalcet dosing frequency at initiation of treatment|Initiation of treatment|Full Analysis Set||Participants|||Number
795638|NCT00925587|Secondary|Ratio of Darbepoetin Alfa Dose to Baseline at Week 17|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 17|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||ratio||95% Confidence Interval|Geometric Mean
795639|NCT00925587|Secondary|Ratio of Darbepoetin Alfa Dose to Baseline at Week 15|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 15|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||ratio||95% Confidence Interval|Geometric Mean
795640|NCT00925587|Secondary|Ratio of Darbepoetin Alfa Dose to Baseline at Week 13|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 13|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||ratio||95% Confidence Interval|Geometric Mean
795641|NCT00925587|Secondary|Ratio of Darbepoetin Alfa Dose to Baseline at Week 11|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 11|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||ratio||95% Confidence Interval|Geometric Mean
795642|NCT00925587|Secondary|Ratio of Darbepoetin Alfa Dose to Baseline at Week 9|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 9|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||ratio||95% Confidence Interval|Geometric Mean
795643|NCT00925587|Secondary|Ratio of Darbepoetin Alfa Dose to Baseline at Week 7|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 7|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||ratio||95% Confidence Interval|Geometric Mean
795644|NCT00925587|Secondary|Ratio of Darbepoetin Alfa Dose to Baseline at Week 5|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 5|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||ratio||95% Confidence Interval|Geometric Mean
795645|NCT00925587|Secondary|Ratio of Darbepoetin Alfa Dose to Baseline at Week 3|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 3|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||ratio||95% Confidence Interval|Geometric Mean
795646|NCT00925587|Secondary|Darbepoetin Alfa Dose During the Evaluation Period (Average of Weeks 29-33)|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Weeks 29-33|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||µg/wk||95% Confidence Interval|Geometric Mean
795647|NCT00925587|Secondary|Darbepoetin Alfa Dose at Week 31|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 31|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||µg/wk||95% Confidence Interval|Geometric Mean
795648|NCT00925587|Secondary|Darbepoetin Alfa Dose at Week 29|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 29|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||µg/wk||95% Confidence Interval|Geometric Mean
795649|NCT00925587|Secondary|Darbepoetin Alfa Dose at Week 27|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 27|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||µg/wk||95% Confidence Interval|Geometric Mean
795650|NCT00925587|Secondary|Darbepoetin Alfa Dose at Week 25|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 25|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||µg/wk||95% Confidence Interval|Geometric Mean
795651|NCT00925587|Secondary|Darbepoetin Alfa Dose at Week 23|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 23|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||µg/wk||95% Confidence Interval|Geometric Mean
795652|NCT00925587|Secondary|Darbepoetin Alfa Dose at Week 21|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 21|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||µg/wk||95% Confidence Interval|Geometric Mean
795653|NCT00925587|Secondary|Darbepoetin Alfa Dose at Week 19|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 19|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||µg/wk||95% Confidence Interval|Geometric Mean
795654|NCT00925587|Secondary|Darbepoetin Alfa Dose at Week 17|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 17|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||µg/wk||95% Confidence Interval|Geometric Mean
795655|NCT00925587|Secondary|Darbepoetin Alfa Dose at Week 15|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 15|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||µg/wk||95% Confidence Interval|Geometric Mean
795656|NCT00925587|Secondary|Darbepoetin Alfa Dose at Week 13|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 13|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||µg/wk||95% Confidence Interval|Geometric Mean
795657|NCT00925587|Secondary|Darbepoetin Alfa Dose at Week 11|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 11|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||µg/wk||95% Confidence Interval|Geometric Mean
795658|NCT00925587|Secondary|Darbepoetin Alfa Dose at Week 9|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 9|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||µg/wk||95% Confidence Interval|Geometric Mean
795659|NCT00925587|Secondary|Darbepoetin Alfa Dose at Week 7|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 7|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||µg/wk||95% Confidence Interval|Geometric Mean
795660|NCT00925587|Secondary|Darbepoetin Alfa Dose at Week 5|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 5|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||µg/wk||95% Confidence Interval|Geometric Mean
795661|NCT00925587|Secondary|Darbepoetin Alfa Dose at Week 3|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 3|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||µg/wk||95% Confidence Interval|Geometric Mean
795662|NCT00925587|Secondary|Darbepoetin Alfa Dose at Week 1|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 1|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||µg/wk||95% Confidence Interval|Geometric Mean
795663|NCT00925587|Secondary|Hb at Week 33||Week 33|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||g/dL||Standard Error|Mean
795664|NCT00925587|Secondary|Hb at Week 31||Week 31|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||g/dL||Standard Error|Mean
795665|NCT00925587|Secondary|Hb at Week 29||Week 29|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||g/dL||Standard Error|Mean
795666|NCT00925587|Secondary|Hb at Week 27||Week 27|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||g/dL||Standard Error|Mean
795667|NCT00925587|Secondary|Hb at Week 25||Week 25|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||g/dL||Standard Error|Mean
795668|NCT00925587|Secondary|Hb at Week 23||Week 23|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||g/dL||Standard Error|Mean
795669|NCT00925587|Secondary|Hb at Week 21||Week 21|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||g/dL||Standard Error|Mean
795670|NCT00925587|Secondary|Hb at Week 19||Week 19|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||g/dL||Standard Error|Mean
795671|NCT00925587|Secondary|Hb at Week 17||Week 17|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||g/dL||Standard Error|Mean
795672|NCT00925587|Secondary|Hb at Week 15||Week 15|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||g/dL||Standard Error|Mean
795673|NCT00925587|Secondary|Hb at Week 13||Week 13|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||g/dL||Standard Error|Mean
795674|NCT00925587|Secondary|Hb at Week 11||Week 11|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||g/dL||Standard Error|Mean
795675|NCT00925587|Secondary|Hb at Week 9||Week 9|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||g/dL||Standard Error|Mean
795676|NCT00925587|Secondary|Hb at Week 7||Week 7|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||g/dL||Standard Error|Mean
795677|NCT00925587|Secondary|Hb at Week 5||Week 5|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||g/dL||Standard Error|Mean
795678|NCT00925587|Secondary|Hb at Week 3||Week 3|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||g/dL||Standard Error|Mean
795679|NCT00925587|Secondary|Hb at Baseline||Baseline|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||g/dL||Standard Error|Mean
795680|NCT00925587|Secondary|Achievement of Both a Hb >= 10.0 g/dL and a >= 1.0 g/dL Increase From Baseline at Any Time Point Following de Novo Darbepoetin Alfa Administration.||Baseline to Week 33|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||Percentage of Participants||95% Confidence Interval|Number
795681|NCT00925587|Primary|Hb Change Between Baseline and the Evaluation Period (Average of Weeks 29-33)|The Adjusted Analysis is the primary analysis and includes treatment group and baseline Hb value as covariates. Non-inferiority is concluded if the lower limit of the 95% confidence interval for the mean difference is above -0.5g/dL.|Baseline Week 33|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||g/dL||95% Confidence Interval|Least Squares Mean
795682|NCT00925600|Other Pre-specified|Number of Participants With Adverse Events|"Adverse events (AEs) were assessed for severity by the investigator according to the Common Terminology Criteria for Adverse Events (CTCAE) severity grading scale, version 3.0, where Grade 1 = Mild AE, Grade 2 = Moderate AE, Grade 3 = Severe AE, Grade 4 =Life-threatening AE and Grade 5 = Death due to AE.
Treatment-related AEs (TRAEs) include only events for which the investigator indicated there was a reasonable possibility they may have been caused by the study drug."|12 months|All enrolled participants who received at least one dose of study drug. Three participants randomized to the placebo group who received at least 1 dose of denosumab in error are analyzed in the denosumab group for safety.||participants|||Number
795683|NCT00925600|Other Pre-specified|Change From Baseline in Refraction Needed to Achieve BCVA|Refraction error was measured using a phoropter. The change from baseline in spherical refraction error needed to achieve BCVA is reported.|Baseline and months 3, 6, 9, and 12|"Lens opacification analysis set with evaluable assessments at both baseline and each time point in the same eye.
n=the number of evaluable eyes in the lens opacification analysis set at the corresponding time point; 3 participants randomized to placebo who received denosumab in error are analyzed in the denosumab group."||diopters|eyes|Standard Deviation|Mean
795700|NCT00925769|Secondary|Part 1: Time to Reach Cmax (Tmax) of Erlotinib and Its Metabolite OSI-420 (CP373420), Capecitabine and Its Metabolites (5'-DFCR and 5'-DFUR)||CAP: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6 hours (h) of every 2-week cycle (until Week 259) ERL: 2, 3 4, 5, 6, 7, 8, 10, 24, 28, 48, 52, 72, 76, 96, 100, 120, 124, 144, 148, 168 and 172 h of every 2-week cycle (until Week 259)|"Per-protocol population. Here n signifies the number of participants who were evaluable for each drug for each arm, respectively."||hours (h)||Full Range|Median
815823|NCT01102374|Secondary|Number of Upper Respiratory Infections||12 months|||events|||Number
795684|NCT00925600|Other Pre-specified|Percentage of Participants With a Decrease From Baseline in Best Corrected Visual Acuity (BCVA) of ≥ 10 Letters|"The best corrected visual acuity (BCVA) is the best vision one can achieve with correction (such as eye glasses) as measured on an eye chart. BCVA was assessed by a trained ophthalmologist using the Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart at 4 meters. The modified University of Crete ETDRS chart was used in Ukraine, Greece, Russia and Bulgaria, which do not use the Roman alphabet. The 2000 series revised ETDRS chart was used to assess the change in all other countries.
The letter score was calculated based on the number of letters that were correctly identified; higher letter scores correspond to better visual acuity."|Baseline and Months 3, 6, 9 and 12|"Lens opacification analysis set with evaluable assessments at both baseline and the time point of interest in the same eye (as indicated by n). Three participants randomized to placebo who received at least 1 dose of denosumab in error are analyzed in the denosumab group."||percentage of participants|||Number
795685|NCT00925600|Other Pre-specified|Percentage of Participants With Confirmed Lens Opacification Event Development or Progression by Month 12|"The Lens Opacities Classification System III (LOCS III) is a slit lamp based opacification grading method. Photographs of slit lamp cross-sections of the lens are used as references for grading nuclear opalescence (NO) and nuclear color (NC), and photographs of the lens seen by retroillumination are used as references for grading cortical (C) and posterior subcapsular (P) cataract. Opacification severity is graded on a decimal scale, scores can range from 0.1 to 6.9 for NO and NC and from 0.1 to 5.9 for C and P. For each opacification type the higher grading scores indicate greater severity.
Lens opacification event development or progression by month 12 was based on a change of ≥ 1.0 in P, ≥ 1.0 in C, or ≥ 0.7 in NO in the LOCS III score from baseline. A confirmed lens opacification event development or progression was defined as 2 directly subsequent events per protocol assessments at the same location (P, C, NO) using LOCS III as above."|12 months|"Lens opacification analysis set with at least two post-baseline LOCS III measurements by month 12.
Three participants randomized to placebo who received at least 1 dose of denosumab in error are analyzed in the denosumab group."||percentage of participants|||Number
795686|NCT00925600|Other Pre-specified|Percentage of Participants With Lens Opacification Event Development or Progression by Month 6|The Lens Opacities Classification System III (LOCS III) is a slit lamp based opacification grading method. Photographs of slit lamp cross-sections of the lens are used as references for grading nuclear opalescence (NO) and nuclear color (NC), and photographs of the lens seen by retroillumination are used as references for grading cortical (C) and posterior subcapsular (P) cataract. Opacification severity is graded on a decimal scale, scores can range from 0.1 to 6.9 for NO and NC and from 0.1 to 5.9 for C and P. For each opacification type the higher grading scores indicate greater severity. Lens opacification event development or progression by month 6 was based on a change of ≥ 1.0 in P, ≥ 1.0 in C, or ≥ 0.7 in NO in the LOCS III score from baseline.|6 months|Lens opacification analysis set includes randomized participants who received ≥1 dose of study drug, had an evaluable baseline and at least 1 evaluable post-baseline LOCS III assessment at the corresponding lens site at or before month 6. Three participants randomized to placebo who received denosumab in error are analyzed in the denosumab group.||percentage of participants|||Number
795687|NCT00925600|Other Pre-specified|Percentage of Participant With Lens Opacification Event Development or Progression by Month 12 Based on a Change of ≥ 1.5 in P, ≥ 1.5 in C, or ≥ 1.5 in NO in the LOCS III Score|The Lens Opacities Classification System III (LOCS III) is a slit lamp based opacification grading method. Photographs of slit lamp cross-sections of the lens are used as references for grading nuclear opalescence (NO) and nuclear color (NC), and photographs of the lens seen by retroillumination are used as references for grading cortical (C) and posterior subcapsular (P) cataract. Opacification severity is graded on a decimal scale, scores can range from 0.1 to 6.9 for NO and NC and from 0.1 to 5.9 for C and P. For each opacification type the higher grading scores indicate greater severity. Lens opacification event development or progression by month 12 was based on a change ≥ 1.5 in P, ≥ 1.5 in C, or ≥ 1.5 in NO in the LOCS III score from baseline.|12 months|The lens opacification analysis set includes randomized participants who received ≥1 dose of study drug, had an evaluable baseline and at least 1 evaluable post-baseline LOCS III assessment at the corresponding lens site. Three participants randomized to placebo who eceived ≥ 1 dose of denosumab in error are analyzed in the denosumab group.||percentage of participants|||Number
795688|NCT00925600|Primary|Percentage of Participants With Lens Opacification Event Development or Progression by Month 12|The Lens Opacities Classification System III (LOCS III) is a slit lamp based opacification grading method. Photographs of slit lamp cross-sections of the lens are used as references for grading nuclear opalescence (NO) and nuclear color (NC), and photographs of the lens seen by retroillumination are used as references for grading cortical (C) and posterior subcapsular (P) cataract. Opacification severity is graded on a decimal scale, scores can range from 0.1 to 6.9 for NO and NC and from 0.1 to 5.9 for C and P. For each opacification type the higher grading scores indicate greater severity. Lens opacification event development or progression by month 12 was based on a change of ≥ 1.0 in P, ≥ 1.0 in C, or ≥ 0.7 in NO in the LOCS III score from baseline.|12 months|The lens opacification analysis set includes randomized participants who received ≥1 dose of study drug, had an evaluable baseline and at least 1 evaluable post-baseline LOCS III assessment at the corresponding lens site. Three participants randomized to placebo who received ≥ 1 dose of denosumab in error are analyzed in the denosumab group.||percentage of participants|||Number
795689|NCT00925704|Secondary|Time of Maximum Plasma Concentration (Tmax) for Exogenous Calcitriol|This shows the effect that lanthanum carbonate or sevelamer carbonate has on the pharmacokinetics of oral calcitriol. Exogenous calcitriol was the difference between total calcitriol value and the baseline exogenous calcitriol value at each sampling timepoint.|pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hours post calcitriol dose|PK set||hours||95% Confidence Interval|Median
795690|NCT00925704|Secondary|Maximum Plasma Concentration (Cmax) for Exogenous Calcitriol|This shows the effect that lanthanum carbonate or sevelamer carbonate has on the pharmacokinetics of oral calcitriol. Exogenous calcitriol was the difference between total calcitriol value and the baseline exogenous calcitriol value at each sampling timepoint.|pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hours post calcitriol dose|PK set||pg/ml||95% Confidence Interval|Least Squares Mean
795824|NCT00918736|Secondary|The American Orthopedic Foot and Ankle Society (AOFAS) Ankle/Hindfoot Score|The American Orthopedic Foot and Ankle Society (AOFAS) ankle/hindfoot score is a 100-point scale that devotes 40 points to pain, 50 points to function and 10 points to alignment. The maximum score of 100 points denotes no pain and normal function and alignment|6 months||10/2009||||
795691|NCT00925704|Primary|Area Under the Serum Concentration-time Curve (AUC 0-48) for Exogenous Calcitriol|This shows the effect that lanthanum carbonate or sevelamer carbonate has on the pharmacokinetics of oral calcitriol. Exogenous calcitriol was the difference between total calcitriol value and the baseline exogenous calcitriol value at each sampling timepoint.|pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hours post calcitriol dose|Pharmacokinetic set (PK) consists of subjects who received at least 1 dose of investigational product, had evaluable serum concentration-time profiles for calcitriol through 48 hours post-dosing on Day 1 of any treatment period and did not vomit between dosing and 10 hours post-dose on Day 1 of that treatment period.||pg*h/ml||95% Confidence Interval|Least Squares Mean
795692|NCT00925769|Primary|Part 1: PRD of Bevacizumab for Part 2|Once the MTD was reached then the preceding lower dose level was used as PRD. MTD for each of the medications was defined as the lowest dose studied which resulted in DLT in at least 33% of participants of the same quality category. DLT was defined as >= G3 or G4 toxicity; >= G3 non-hematological toxicities directly related to study treatment (other than untreated nausea/vomiting, alopecia, G3/G4 bilirubinemia for less than 7 days due to edema of the ductus choledochus and anemia); G4 thrombocytopenia, neutropenia lasting >= 7 days or G3 thrombocytopenia with complications, requiring transfusions, febrile neutropenia; stopping of oral CAP and/or ERL intake for >= 7 days, and/or cancellation of one or more BEV infusion(s) due to AEs. If MTD was not defined for a drug treatment then the maximum planned dose of that particular drug was considered as PRD for Part 2.|Up to Week 6 (Cycle 1-3)|Per-protocol population.||mg/kg Q2W|||Number
795693|NCT00925769|Primary|Part 1: PRD of Erlotinib for Part 2|Once the MTD was reached then the preceding lower dose level was used as PRD. MTD for each of the medications was defined as the lowest dose studied which resulted in DLT in at least 33% of participants of the same quality category. DLT was defined as >= G3 or G4 toxicity; >= G3 non-hematological toxicities directly related to study treatment (other than untreated nausea/vomiting, alopecia, G3/G4 bilirubinemia for less than 7 days due to edema of the ductus choledochus and anemia); G4 thrombocytopenia, neutropenia lasting >= 7 days or G3 thrombocytopenia with complications, requiring transfusions, febrile neutropenia; stopping of oral CAP and/or ERL intake for >= 7 days, and/or cancellation of one or more BEV infusion(s) due to AEs. If MTD was not defined for a drug treatment then the maximum planned dose of that particular drug was considered as PRD for Part 2.|Up to Week 6 (Cycle 1-3)|Per-protocol population.||mg/day|||Number
795694|NCT00925769|Secondary|Part 2: Overall Survival|Survival was the interval of time from date of first dose of study medication to date of death at any time. Participants who had not died were censored at the date of last contact when they were known to be alive.|From baseline until death (Up to Week 259)|Data was not reported as there were no participants analyzed since Part 2 of the study was not fully implemented.|||||
795695|NCT00925769|Secondary|Part 2: Percentage of Participants With Clinical Benefit Response|Clinical benefit response was defined as a composite of pain control, Karnofsky performance status (KPS), and weight. The KPS allows participants to be classified as per their functional impairment (abnormal function). It was recorded on an 11-point scale; 0= “dead” to 100= “Normal, no complaints, no evidence of disease” and sub-divided to 3 categories; 0 to 40 = “Unable to care for self, requires institutional or hospital care or equivalent, disease may be rapidly progressing”; 50 to 70= “Unable to work, able to live at home and care for most personal needs, varying amount of assistance needed and 80 to 100= “Able to carry on normal activity; no special care is needed”.|One week before start of study treatment and weekly until disease progression or death (Up to Week 259)|Data was not reported as there were no participants analyzed since Part 2 of the study was not fully implemented.|||||
795696|NCT00925769|Secondary|Part 2: Percentage of Participants With Disease Control|A participant was defined as having controlled disease if they sustained a Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) during the assessment. As per RECIST v1.1, CR is defined as the disappearance of all target and non-target lesions and normalization of tumor marker level; PR is defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter; SD for target lesions is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started and SD for non-target lesions defined as persistence of 1 or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.|From baseline thereafter, every 6 weeks (±7 days), then 1 week after last dose (follow-up), thereafter every 6 weeks (±7 days) until disease progression (up to Week 259)|Data was not reported as there were no participants analyzed since Part 2 of the study was not fully implemented.|||||
795697|NCT00925769|Secondary|Part 2: Percentage of Participants Free From Disease Progression|As per Response Evaluation Criteria In Solid Tumors (RECIST) version (v) 1.1, progressive disease (PD) is defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and non-target lesions) or the unequivocal progression of existing non-target lesions.|Month 6|Data was not reported as there were no participants analyzed since Part 2 of the study was not fully implemented.|||||
795698|NCT00925769|Secondary|Part 1: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Measurable Concentration (AUClast) of Erlotinib and Its Metabolite OSI-420 (CP373420), Capecitabine and Its Metabolites (5'-DFCR and 5'-DFUR)||CAP: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6 hours (h) of every 2-week cycle (until Week 259) ERL: 2, 3 4, 5, 6, 7, 8, 10, 24, 28, 48, 52, 72, 76, 96, 100, 120, 124, 144, 148, 168 and 172 h of every 2-week cycle (until Week 259)|"Per-protocol population. Here n signifies the number of participants who were evaluable for each drug for each arm, respectively."||h*µg/mL||Standard Deviation|Mean
795699|NCT00925769|Secondary|Part 1: Last Quantifiable Drug Concentration (Clast) of Erlotinib and Its Metabolite OSI-420 (CP373420), Capecitabine and Its Metabolites (5'-DFCR and 5'-DFUR)||CAP: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6 hours (h) of every 2-week cycle (until Week 259) ERL: 2, 3 4, 5, 6, 7, 8, 10, 24, 28, 48, 52, 72, 76, 96, 100, 120, 124, 144, 148, 168 and 172 h of every 2-week cycle (until Week 259)|"Per-protocol population. Here n signifies the number of participants who were evaluable for each drug for each arm, respectively."||µg/mL||Standard Deviation|Mean
795750|NCT00926289|Secondary|Number of Patients With DBP Control (DBP < 90 mmHg) at Week 5|DBP control is defined as DBP<90 mmHg|Week 5 timepoint|The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm||participants|||Number
795701|NCT00925769|Primary|Part 1: Preliminary Recommended Dose (PRD) of Capecitabine for Part 2|Once the MTD was reached then the preceding lower dose level was used as PRD. MTD for each of the medications was defined as the lowest dose studied which resulted in dose limiting toxicity (DLT) in at least 33% of participants of the same quality category. DLT was defined as >= G3 or G4 toxicity; >= G3 non-hematological toxicities directly related to study treatment (other than untreated nausea/vomiting, alopecia, G3/G4 bilirubinemia for less than 7 days due to edema of the ductus choledochus and anemia); G4 thrombocytopenia, neutropenia lasting >= 7 days or G3 thrombocytopenia with complications, requiring transfusions, febrile neutropenia; stopping of oral CAP and/or ERL intake for >= 7 days, and/or cancellation of one or more BEV infusion(s) due to AEs. If MTD was not defined for a drug treatment then the maximum planned dose of that particular drug was considered as PRD for Part 2.|Up to Week 6 (Cycle 1-3)|Per-protocol population.||mg/m^2 BID|||Number
795702|NCT00925769|Primary|Part 1: MTD of Bevacizumab|MTD for each of the medications was defined as the lowest dose studied which resulted in DLT in at least 33% of participants of the same quality category. DLT was defined as >= G3 or G4 toxicity; >= G3 non-hematological toxicities directly related to study treatment (other than untreated nausea/vomiting, alopecia, G3/G4 bilirubinemia for less than 7 days due to edema of the ductus choledochus and anemia); G4 thrombocytopenia, neutropenia lasting >= 7 days or G3 thrombocytopenia with complications, requiring transfusions, febrile neutropenia; stopping of oral CAP and/or ERL intake for >= 7 days, and/or cancellation of one or more BEV infusion(s) due to AEs.|Up to Week 6 (Cycle 1-3)|Per-protocol population.||mg/kg once every 2 weeks (Q2W)|||Number
795703|NCT00925769|Secondary|Part 1: Maximum Serum Concentration (Cmax) of Erlotinib and Its Metabolite OSI-420 (CP373420), Capecitabine and Its Metabolites (5'-Deoxy-5-Fluorocytidine [5'-DFCR] and 5'-Deoxy-5-Fluorouridine [5'-DFUR])||CAP: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6 hours (h) of every 2-week cycle (until Week 259) ERL: 2, 3 4, 5, 6, 7, 8, 10, 24, 28, 48, 52, 72, 76, 96, 100, 120, 124, 144, 148, 168 and 172 h of every 2-week cycle (until Week 259)|"Per-protocol population. Here n signifies the number of participants who were evaluable for each drug for each arm, respectively."||micrograms per milliliter (µg/mL)||Standard Deviation|Mean
795704|NCT00925769|Primary|Part 1: MTD of Erlotinib|MTD for each of the medications was defined as the lowest dose studied which resulted in DLT in at least 33% of participants of the same quality category. DLT was defined as >= G3 or G4 toxicity; >= G3 non-hematological toxicities directly related to study treatment (other than untreated nausea/vomiting, alopecia, G3/G4 bilirubinemia for less than 7 days due to edema of the ductus choledochus and anemia); G4 thrombocytopenia, neutropenia lasting >= 7 days or G3 thrombocytopenia with complications, requiring transfusions, febrile neutropenia; stopping of oral CAP and/or ERL intake for >= 7 days, and/or cancellation of one or more BEV infusion(s) due to AEs.|Up to Week 6 (Cycle 1-3)|Per-protocol population.||mg/day|||Number
795705|NCT00925769|Primary|Part 1: Maximum Tolerated Dose (MTD) of Capecitabine|MTD for each of the medications was defined as the lowest dose studied which resulted in dose limiting toxicity (DLT) in at least 33 percent (%) of participants of the same quality category. DLT was defined as any greater than or equal to (>=) Grade (G) 3 or G4 toxicity; >= G3 non-hematological toxicities directly related to study treatment (other than untreated nausea/vomiting, alopecia, G3/G4 bilirubinemia for less than 7 days due to edema of the ductus choledochus and anemia); G4 thrombocytopenia, neutropenia lasting >= 7 days or G3 thrombocytopenia with complications, requiring transfusions, febrile neutropenia; stopping of oral CAP and/or ERL intake for >= 7 days, and/or cancellation of one or more BEV infusion(s) due to adverse events (AEs).|Up to Week 6 (Cycle 1-3)|Per-protocol population.||mg/m^2 BID|||Number
795706|NCT00925782|Primary|Concentration-Max (Cmax)|"Cmax was one of the pharmacokinetic endpoints to confirm pharmacokinetic similarity between Melphalan HCl for Injection (Propylene Glycol-Free) and Alkeran for Injection in patients with multiple myeloma. Pharmacokinetic similarity was defined as a difference of 20% or less in the 90% confidence intervals (CIs) for the ratios of the pharmacokinetic parameters (calculated using log-transformed data) for the two formulations.
The Cmax results provided is the summary of Melphalan PK following Melphalan-Alkeran injection in Sequence 1 and Alkeran-melphalan injection in Sequence 2."|Day -3 and Day -2|The pharmacokinetic-evaluable population was defined as all patients who completed dosing and adequate subsequent pharmacokinetic blood draws for the calculation of area under the plasma concentration-time curve (AUC) and maximum plasma concentration (Cmax) for both Melphalan HCl for Injection and Alkeran for Injection.||ng/mL||Standard Deviation|Geometric Mean
795707|NCT00925782|Secondary|Determination of Engraftment Following Melphalan-alkeran Sequence and Alkeran-melphalan Sequence Followed by ASCT|"Neutrophil engraftment was defined as the first day of 3 consecutive days where ANC (absolute neutrophil count) was higher than 500/ul. The two drug treatments in this cross-over design were administered on 2 subsequent days (Day -3 and Day -2). No per arm analysis was performed.
Since the two treatments were administered consecutively with 1 day rest, the time to engraftment and engraftment rate was measured after both treatments were administered."|30 days|The intent-to-treat (ITT) population was defined as all patients who received at least one dose of Melphalan HCl for Injection (Propylene Glycol-Free) or Alkeran for Injection. All efficacy analyses were to be performed on the ITT population.||days||Standard Deviation|Mean
795708|NCT00925782|Secondary|Determination of Myeloablation Following Melphalan-alkeran Sequence and Alkeran-melphalan Sequence Followed by ASCT|"ANC <0.5 × 109/L, absolute lymphocyte count (ALC) <0.1 × 109/L, platelet count <20,000/mm3, or bleeding requiring transfusion. The first of 2 consecutive days for which cell counts drop below these cutoff levels was recorded as the date of myeloablation.
Since the two treatments were administered consecutively with 1 day rest, the time to myeloablation and myeloablation rate was measured after both treatments were administered.
Comparison of sequence effect was not planned in the study and due to small sample size, it was not performed."|30 days|The intent-to-treat (ITT) population was defined as all patients who received at least one dose of Melphalan HCl for Injection (Propylene Glycol-Free) or Alkeran for Injection. All efficacy analyses were to be performed on the ITT population.||days||Standard Deviation|Mean
795731|NCT00926263|Secondary|Serum Concentration of Fasting Glucose|Glucose is one of the IGF-axis related biomarkers. Part of the secondary objectives of the study was to explore the relationships of plasma CP-751,871 concentrations to such biomarkers. Cmax is the mean ± standard deviation (SD) concentration observed at the time of maximal change from baseline.|Day 1 pre-dose, 1 hour post dose, Day 2 (24 hours post-dose), Day 8, 15, 22, 29, 43, 57, 71, 85|All treated participants who had at least 1 postdose concentration measurement.||mg/dL||Standard Deviation|Mean
815824|NCT01102374|Secondary|Fractures||12 months|||events|||Number
795709|NCT00925782|Primary|Area Under the Curve (0-t)|"AUC (0–t) was one of the pharmacokinetic endpoints to confirm pharmacokinetic similarity between Melphalan HCl for Injection (Propylene Glycol-Free) and Alkeran for Injection in patients with multiple myeloma. Pharmacokinetic similarity was defined as a difference of 20% or less in the 90% confidence intervals (CIs) for the ratios of the pharmacokinetic parameters (calculated using log-transformed data) for the two formulations.
The AUC results provided is the summary of Melphalan PK following Melphalan-Alkeran injection in Sequence 1 and Alkeran-melphalan injection in Sequence 2."|Day -3 and Day -2|"The pharmacokinetic-evaluable population was defined as all patients who completed dosing and adequate pharmacokinetic blood draws for the calculation of AUC and Cmax for both Melphalan HCl for Injection and Alkeran for Injection.
The results are presented by each drug group that combines data from both sequence."||min*ng/mL||Standard Deviation|Geometric Mean
795710|NCT00925899|Secondary|General Fatigue Measured by the The Multidimensional Fatigue Inventory (MFI)|"Change from baseline to week one in intervention group minus change from baseline to week one in control group.
Because it was a cross-over trial this was calculated the following way:
Outcomes for arm 1 (melatonin then placebo) were calculated as the difference in mean change scores between week 1 and week 2 (scores for day 7 to day 1-scores for day 17 to day 10). Outcomes for arm 2 (placebo then melatonin) were calculated as the difference in mean change scores between week 2 and week 1 (scores for day 17 to day 10-scores for day 7 to day 1).
The general fatigue scale that consits of four items was converted to a 0 til 100 scale where 100 indicated maximum (worst possible) fatigue.
Note outcome reported for complete compliers"|One week|||units on a scale||Standard Deviation|Mean
795711|NCT00925899|Secondary|Appetite Loss as Measured by the Questionnaire EORTC QLQ-C15-PAL (Groenvold M, Petersen MA, Aaronson NK, et al, Eur J Cancer 42:55-64, 2006)|"Change from baseline to week one in intervention group minus change from baseline to week one in control group.
Because it was a cross-over trial this was calculated the following way:
Outcomes for arm 1 (melatonin then placebo) were calculated as the difference in mean change scores between week 1 and week 2 (scores for day 7 to day 1-scores for day 17 to day 10). Outcomes for arm 2 (placebo then melatonin) were calculated as the difference in mean change scores between week 2 and week 1 (scores for day 17 to day 10-scores for day 7 to day 1).
Appetite loss was converted to a 0 til 100 scale according to the scoring manual for EORTC QLQ C15-PAL where 100 indicated maximum appetite loss (worst possible).
Note outcome reported for complete compliers"|One week|Complete compliers||units on a scale||Standard Deviation|Mean
795712|NCT00925899|Secondary|Quality of Life as Measured by the Questionnaire EORTC QLQ-C15-PAL (Groenvold M, Petersen MA, Aaronson NK, et al, Eur J Cancer 42:55-64, 2006)|"Change from baseline to week one in intervention group minus change from baseline to week one in control group.
Because it was a cross-over trial this was calculated the following way:
Outcomes for arm 1 (melatonin then placebo) were calculated as the difference in mean change scores between week 1 and week 2 (scores for day 7 to day 1-scores for day 17 to day 10). Outcomes for arm 2 (placebo then melatonin) were calculated as the difference in mean change scores between week 2 and week 1 (scores for day 17 to day 10-scores for day 7 to day 1).
Quality of Life was converted to a 0 til 100 scale according to the scoring manual for EORTC QLQ C15-PAL where 100 indicated best possible quality of life.
Note outcome reported for complete compliers"|One week|Complete compliers||units on a scale||Standard Deviation|Mean
795713|NCT00925899|Secondary|Pain as Measured by the Questionnaire EORTC QLQ-C15-PAL (Groenvold M, Petersen MA, Aaronson NK, et al, Eur J Cancer 42:55-64, 2006)|"Change from baseline to week one in intervention group minus change from baseline to week one in control group.
Because it was a cross-over trial this was calculated the following way:
Outcomes for arm 1 (melatonin then placebo) were calculated as the difference in mean change scores between week 1 and week 2 (scores for day 7 to day 1-scores for day 17 to day 10). Outcomes for arm 2 (placebo then melatonin) were calculated as the difference in mean change scores between week 2 and week 1 (scores for day 17 to day 10-scores for day 7 to day 1).
Pain was converted to a 0 til 100 scale according to the scoring manual for EORTC QLQ C15-PAL where 100 indicated maximum pain.
Note outcome reported for complete compliers"|One week|Complete compliers||units on a scale||Standard Deviation|Mean
795714|NCT00925899|Secondary|Emotional Function as Measured by the Questionnaire EORTC QLQ-C15-PAL (Groenvold M, Petersen MA, Aaronson NK, et al, Eur J Cancer 42:55-64, 2006)|"Change from baseline to week one in intervention group minus change from baseline to week one in control group.
Because it was a cross-over trial this was calculated the following way:
Outcomes for arm 1 (melatonin then placebo) were calculated as the difference in mean change scores between week 1 and week 2 (scores for day 7 to day 1-scores for day 17 to day 10). Outcomes for arm 2 (placebo then melatonin) were calculated as the difference in mean change scores between week 2 and week 1 (scores for day 17 to day 10-scores for day 7 to day 1).
Emotional function was converted to a 0 til 100 scale according to the scoring manual for EORTC QLQ C15-PAL where 100 indicated the best possible emotional function.
Note outcome reported for complete compliers"|One week|||units on a scale||Standard Deviation|Mean
795715|NCT00925899|Secondary|Insomnia Measured by the Insomnia Item in the Questionnaire EORTC QLQ-C15-PAL|"Primary outcome: Change from baseline to week one in intervention group minus change from baseline to week one in control group.
Because it was a cross-over trial this was calculated the following way:
Outcomes for arm 1 (melatonin then placebo) were calculated as the difference in mean change scores between week 1 and week 2 (scores for day 7 to day 1-scores for day 17 to day 10). Outcomes for arm 2 (placebo then melatonin) were calculated as the difference in mean change scores between week 2 and week 1 (scores for day 17 to day 10-scores for day 7 to day 1).
Insomnia was converted to a 0 til 100 scale according to the scoring manual for EORTC QLQ C15-PAL where 100 indicated maximum insomnia."|One week|Complete compliers||units on a scale||Standard Deviation|Mean
795732|NCT00926263|Secondary|Serum Concentration of Insulin|Insulin is one of the IGF-axis related biomarkers. Part of the secondary objectives of the study was to explore the relationships of plasma CP-751,871 concentrations to such biomarkers. Cmax is the mean ± standard deviation (SD) concentration observed at the time of maximal change from baseline.|Day 1 pre-dose, 1 hour post dose, Day 2 (24 hours post-dose), Day 8, 15, 22, 29, 43, 57, 71, 85|All treated participants who had at least 1 postdose concentration measurement.||mIU/mL||Standard Deviation|Mean
795751|NCT00926289|Secondary|Number of Patients With DBP Control (DBP < 90 mmHg) at Week 7|DBP control is defined as DBP<90 mmHg|Week 7 timepoint|The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm||Participants|||Number
815825|NCT01102374|Secondary|Falls||12 months|||Events|||Number
795716|NCT00925899|Primary|Fatigue as Measured by the Physical Fatigue Scale in the The Multidimensional Fatigue Inventory (MFI) (Smets EM, Garssen B, Bonke B, et al., J Psychosom Res 39:315-325, 1995)|"Primary outcome: Change from baseline to week one in intervention group minus change from baseline to week one in control group.
Because it was a cross-over trial this was calculated the following way:
Outcomes for arm 1 (melatonin then placebo) were calculated as the difference in mean change scores between week 1 and week 2 (scores for day 7 to day 1-scores for day 17 to day 10). Outcomes for arm 2 (placebo then melatonin) were calculated as the difference in mean change scores between week 2 and week 1 (scores for day 17 to day 10-scores for day 7 to day 1).
The physical fatigue scale conists of four item each ranging from one to five. The four item were summed and the scae was converted to 0 to 100, where 100 indicated maximum fatigue."|One week|The primary analysis was a per protocol analysis including only complete compliers, defined as those patients who had consumed at least 5 capsules per week for the 2 weeks in part 1 and who had answered the MFI-20 on days 1, 7, 10, and 17.||units on a scale||Standard Deviation|Mean
795717|NCT00925938|Secondary|Percentage of Participants With Adverse Events||9 days|||Percentage of participants|||Number
795718|NCT00925938|Secondary|Physician Assessment of Ease of Cervical Dilation;||18 - 24 hours|||percentage of participants|||Number
795719|NCT00925938|Secondary|Total Procedure Time From Insertion of the First Hegar Dilator to Completion of the Hysteroscopy Procedure;||18 - 24 hours|||minutes||Standard Deviation|Mean
795720|NCT00925938|Secondary|Percent of Women Requiring Further Dilatation in Order to Allow Uterine Access||18 - 24 hours|A total of 46 subjects (90.2%) did not achieve their target dilatation after study drug removal (MVPI 400: 8 subjects; MVPI 800: 21 subjects; Placebo: 17 subjects). Forty-five subjects had additional dilatation attempted; additional dilatation was not attempted on one subject (MVPI 800) due to a protocol deviation (MVPI 800: 20 subjects).||percentage of participants|||Number
795721|NCT00925938|Primary|Change in Diameter of the Internal Cervical os From Baseline (Pre-treatment) to Just Prior to the Hysteroscopy Procedure (Post-treatment).||Baseline to 18-24 hours|||mm||Standard Deviation|Mean
795722|NCT00925990|Secondary|Mean Change in Aminotransferases From Baseline to 24 Weeks of Treatment|"Mean absolute changes in ALT (alanine aminotransferase)in the blood from before treatment (baseline)through 24 weeks of treatment are presented.
Mean absolute change in ALT (IU/ml)= ALT(Week 24) - ALT(baseline)"|Baseline and 24 weeks|All patients dosed with at least one dose of study drug were analyzed.||IU/mL||Standard Deviation|Mean
795723|NCT00925990|Primary|Mean Change in HCV-RNA (Hepatitis C Virus Ribonucleic Acid) Levels From Baseline Through 24 Weeks of Treatment|"Measure the mean absolute changes in HCV-RNA (Hepatitis C virus ribonucleic acid, also known as viral load) levels in the blood from before treatment (baseline) through 24 weeks of treatment.
Mean Absolute Change in HCV-RNA (log) = log10(HCV-RNA Week 24) - log10(HCV-RNA Baseline)"|Baseline and 24 weeks|All patients receiving at least one dose of study drug were analyzed for safety.||log (IU/mL)||Standard Deviation|Mean
795724|NCT00926029|Primary|Gingivitis Index|Gingivitis score- scale 0 to 3 (0 = no inflammation,1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)|6 Weeks|||Units on a scale||Standard Deviation|Mean
795725|NCT00926029|Primary|Plaque Index|Plaque Index score scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque,3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|6 weeks|||Units on a scale||Standard Deviation|Mean
795726|NCT00926185|Secondary|Inferior Corneal Staining Score Change From Baseline (CFB) to Day 84|Corneal staining was performed to grade the degree of corneal epithelial cell injury as measured by fluorescence using slit-lamp examination. The staining was graded with the Ophthalmic Research Associates, Inc. (ORA) scale. The corneal surface is divided into three regions: superior, central and inferior. The scores for each of these 3 regions ranged from 0 to 4 (0=no staining; 1=occasional; 2=countable; 3=uncountable, but not confluent; 4=confluent) with 0.5 point increments, and lower score indicates a better outcome. Inferior corneal fluorescein staining scores from the study eye only were reported. Study eye is the 'worse eye', defined as the eye with worse (higher) score at baseline.|Baseline (Day 0) and Day 84|ITT set with LOCF was used for analysis of this outcome. Here, “n” signifies the number of participants evaluable for the respective time points.||units on a scale||Standard Deviation|Mean
795727|NCT00926185|Primary|Inferior Corneal Fluorescein Staining Score in Pre-Controlled Adverse Environment at Day 84|Corneal staining was performed to grade the degree of corneal epithelial cell injury as measured by fluorescence using slit-lamp examination. The staining was graded with the Ophthalmic Research Associates, Inc. (ORA) scale. The corneal surface is divided into three regions: superior, central and inferior. The scores for each of these 3 regions ranged from 0 to 4 (0=no staining; 1=occasional; 2=countable; 3=uncountable, but not confluent; 4=confluent) with 0.5 point increments, and lower score indicates a better outcome. Inferior corneal fluorescein staining scores from the study eye only were reported. Study eye is the 'worse eye', defined as the eye with worse (higher) score at baseline.|Day 84|Intent-to-treat (ITT) population with LOCF defined as all randomized subjects. For the efficacy analysis, the Last Observation Carried Forward (LOCF) method will be used to impute missing values.||units on a scale||Standard Deviation|Mean
795728|NCT00926211|Secondary|Proportion of Harvested Follicles Transected|The proportion of harvested hair follicles that were transected by each harvest method.|Time of harvest (Baseline)|||Proportion of transected follicles||Standard Deviation|Mean
795729|NCT00926211|Primary|Increase in Hair Follicles Present|The increase in the number of hair follicles present at follow-up in each region compared to the number present at baseline.|Change from Baseline at 9 Months|The analysis was based on intention to treat (ITT). Imputation technique was based LOCF.||Hair follicles||Standard Deviation|Mean
795730|NCT00926263|Secondary|Anti-drug Antibodies (ADA) Against CP-751,871 in Serum Samples|Number of participants who tested positive for ADA|Day 1 pre-dose, Day 15, 29, 57, 85|All treated participants.||number of participants|||Number
795749|NCT00926289|Secondary|Number of Patients With DBP Control (DBP < 90 mmHg) at Week 3|DBP control is defined as DBP<90 mmHg|Week 3 timepoint|The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm||Participants|||Number
795733|NCT00926263|Secondary|Serum Concentration of Insulin-like Growth Factor Binding Protein 3 (IGFBP-3)|IGFBP-3 is one of the IGF-axis related biomarkers. Part of the secondary objectives of the study was to explore the relationships of plasma CP-751,871 concentrations to such biomarkers. Cmax is the mean ± standard deviation (SD) concentration observed at the time of maximal change from baseline.|Day 1 pre-dose, 1 hour post dose, Day 2 (24 hours post-dose), Day 8, 15, 22, 29, 43, 57, 71, 85|All treated participants who had at least 1 postdose concentration measurement.||ng/mL||Standard Deviation|Mean
795734|NCT00926263|Secondary|Serum Concentration of Insulin-like Growth Factor 2 (IGF-2)|IGF-2 is one of the IGF-axis related biomarkers. Part of the secondary objectives of the study was to explore the relationships of plasma CP-751,871 concentrations to such biomarkers. Cmax is the mean ± standard deviation (SD) concentration observed at the time of maximal change from baseline.|Day 1 pre-dose, 1 hour post dose, Day 2 (24 hours post-dose), Day 8, 15, 22, 29, 43, 57, 71, 85|All treated participants who had at least 1 postdose concentration measurement.||ng/mL||Standard Deviation|Mean
795735|NCT00926263|Secondary|Serum Concentration of Free Insulin-like Growth Factor 1 (IGF-1)|IGF-1 is one of the IGF-axis related biomarkers. Part of the secondary objectives of the study was to explore the relationships of plasma CP-751,871 concentrations to such biomarkers. Cmax is the mean ± standard deviation (SD) concentration observed at the time of maximal change from baseline.|Day 1 pre-dose, 1 hour post dose, Day 2 (24 hours post-dose), Day 8, 15, 22, 29, 43, 57, 71, 85|All treated participants who had at least 1 postdose concentration measurement.||ng/mL||Standard Deviation|Mean
795736|NCT00926263|Secondary|Serum Concentration of Insulin-like Growth Factor 1 (IGF-1)|IGF-1 is one of the IGF-axis related biomarkers. Part of the secondary objectives of the study was to explore the relationships of plasma CP-751,871 concentrations to such biomarkers. Cmax is the mean ± standard deviation (SD) concentration observed at the time of maximal change from baseline.|Day 1 pre-dose (Baseline), 1 hour post dose, Day 2 (24 hours post-dose), Day 8, 15, 22, 29, 43, 57, 71, 85|All treated participants who had at least 1 postdose concentration measurement.||ng/mL||Standard Deviation|Mean
795737|NCT00926263|Secondary|QTcF After Receiving Moxifloxacin at the Historical Moxifloxacin Median Tmax of 3 Hours||baseline, 3 hours postdose|Data not obtained due to early termination of the study.|||||
795738|NCT00926263|Primary|QTc Using Fridericia's Correction Method (QTcF) After Receiving CP-751,871 at the 20/20 mg/kg Dose Level|QTcF is the time from electrocardiogram Q wave to the end of the T wave corresponding to electrical systole, corrected for heart rate using Fridericia's correction|Day 1 at 1 and 24 hours post-dose, Day 7, 28|Data not obtained due to early termination of the study.|||||
795739|NCT00926263|Primary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Day 1 pre-dose and 1 hour post-dose, Day 2 (24 hours post-dose), 8, 15, 22, 29, 43, 57, 71 and 85|All treated and evaluable participants (had measurements related to the PK parameter stated above).||days||Standard Deviation|Mean
795740|NCT00926263|Primary|Apparent Volume of Distribution (Vz)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.|Day 1 pre-dose and 1 hour post-dose, Day 2 (24 hours post-dose), 8, 15, 22, 29, 43, 57, 71 and 85|All treated and evaluable participants (had measurements related to the PK parameter stated above).||mL/kg||Standard Deviation|Mean
795741|NCT00926263|Primary|Plasma Clearance (CL)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.|Day 1 pre-dose and 1 hour post-dose, Day 2 (24 hours post-dose), 8, 15, 22, 29, 43, 57, 71 and 85|All treated and evaluable participants (had measurements related to the PK parameter stated above).||mL/day/kg||Standard Deviation|Mean
795742|NCT00926263|Primary|Area Under the Curve From Time Zero to the Last Time Point With Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|Day 1 pre-dose and 1 hour post-dose, Day 2 (24 hours post-dose), 8, 15, 22, 29, 43, 57, 71 and 85|All treated participants.||mg*h/L||Standard Deviation|Mean
795743|NCT00926263|Primary|Maximum Observed Plasma Concentration (Cmax)||Day 1 pre-dose and 1 hour post-dose, Day 2 (24 hours post-dose), 8, 15, 22, 29, 43, 57, 71 and 85|All treated participants.||mg/L||Standard Deviation|Mean
795744|NCT00926289|Secondary|BP Categories at Week 7|"BP categories comprise:
BP optimal (SBP <120 mmHg and DBP <80 mmHg)
BP normal (SBP <130 mmHg and DBP <85 mmHg but not ‘optimal’)
BP high normal (SBP <140 mmHg and DBP <90 mmHg but not ‘normal’)
Grade 1 hypertension (SBP <160 mmHg and DBP <100 mmHg but not ‘high normal’)
Grade 2 hypertension (SBP <180 mmHg and DBP <110 mmHg but not ‘Grade 1 hypertension’)
Grade 3 hypertension (SBP ≥180 mmHg or DBP ≥110 mmHg)"|Week 7 timepoint|The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm||Participants|||Number
795745|NCT00926289|Secondary|Number of Participants With DBP Response at Week 7|DBP response is defined as DBP<90 mmHg or a reduction of >= 10 mmHg|Week 7 timepoint|The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm||Participants|||Number
795746|NCT00926289|Secondary|Number of Patients With Systolic Blood Pressure (SBP) Response at Week 7|SBP response is defined as SBP<140 mmHg or a reduction of >= 15 mmHg|Week 7 timepoint|The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm||Participants|||Number
795747|NCT00926289|Secondary|Number of Patients With BP Control at Week 7|BP control is defined as SBP<140 mmHg and DBP < 90 mmHg and is adjusted for baseline DBP|Week 7 timepoint|The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm||Participants|||Number
795748|NCT00926289|Secondary|Number of Patients With Blood Pressure (BP) Control at Week 7|BP control is defined as SBP<140 mmHg and DBP < 90 mmHg and is adjusted for baseline SBP|Week 7 timepoint|The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm||Participants|||Number
820713|NCT01147497|Secondary|Need for Additional Pain Medications After Insertion of the IUD||assessed one week after insertion||||||
795752|NCT00926289|Secondary|Number of Patients With SBP Control (SBP < 140 mmHg) at Week 3|SBP control is defined as SBP < 140 mmHg|Week 3 timepoint|The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm||Participants|||Number
795753|NCT00926289|Secondary|Number of Patients With SBP Control (SBP < 140 mmHg) at Week 5|SBP control is defined as SBP < 140 mmHg|Week 5 timepoint|The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm||Participants|||Number
795754|NCT00926289|Secondary|Number of Patients With SBP Control (SBP < 140 mmHg) at Week 7|SBP control is defined as SBP < 140 mmHg.|Week 7 timepoint|The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm||Participants|||Number
795755|NCT00926289|Secondary|Change From Baseline in Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) to Week 7|The DBP value at baseline was subtracted from the DBP value at Week 7.|Baseline and Week 7|The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm||mmHg||Standard Error|Least Squares Mean
795756|NCT00926289|Secondary|Change From Baseline in Mean Seated Trough Cuff SBP to Week 3|The SBP value at baseline was subtracted from the SBP value at Week 3.|Baseline and Week 3|The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm||mmHg||Standard Error|Least Squares Mean
795757|NCT00926289|Secondary|Change From Baseline in Mean Seated Trough Cuff SBP to Week 5|The SBP value at baseline was subtracted from the SBP value at Week 5.|Baseline and Week 5|The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm||mmHg||Standard Error|Least Squares Mean
795758|NCT00926289|Primary|Change From Baseline in Mean Seated Trough Cuff Systolic Blood Pressure (SBP) to Week 7|The SBP value at baseline was subtracted from the SBP value at Week 7.|Baseline and Week 7|The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm||mmHg||Standard Error|Least Squares Mean
795759|NCT00918125|Other Pre-specified|Mean Knowledge Scores About ICD Therapy One Week Post Intervention.|We assessed knowledge of ICD therapy prior to the educational intervention, directly after the educational intervention and one week later. The tool used was a 13 question tool on key aspects of ICDs, risks and benefits, and health conditions eligible for an ICD. Scores could range from 0-13, with higher score indicating greater levels of knowledge.|one week post intervention|Mean scores were calculated with one point for each correct answer out of 13 questions for all patients with data.||units on a scale||Standard Deviation|Mean
795760|NCT00918125|Secondary|Receipt of an ICD|Patients were asked (or medical records reviewed) to determine if patients did receive an ICD within approximately 3 months post intervention.|3 months|All patients with data at 3 months||participants|||Number
795761|NCT00918125|Secondary|Decisional Conflict Scale|At one week post-intervention, patients were asked 9 questions from a modified decisional conflict scale to assess overall decisional conflict and three subscales (decision uncertainty; factors contributing to uncertainty; and perceived effective decision making). Overall scores range from 9 (no decisional conflict) to 45 (high decisional conflict).|one week post intervention|Patients with data at one week||units on a scale||Standard Deviation|Mean
795762|NCT00918125|Primary|Decision to Receive an ICD|At one week post-intervention, patients were asked what treatment option they preferred: ICD placement with medications; No ICD, continue with medications only; or unsure.|1 week post intervention|All patients with available data at one week||Participants|||Number
795763|NCT00918138|Other Pre-specified|Participants With Reported Hypoglycemic Adverse Events During Treatment Period|Hypoglycemic events are based upon the Saxagliptin Predefined List of Events, which includes hypoglycemia, blood glucose decreased, and hypoglycemic unconsciousness. The Hypoglycemic events occurred in less than 5% of the participants and hence do not appear in the adverse events module.|AEs: up to last treatment day (LTD) +1 day or last visit day (LVD), whichever came last ; SAEs: up to LTD +30 days or LVD + 30 days, whichever came last. Mean duration of exposure=27.7 days for Saxa 5 mg + Met XR 1500 mg, and 28.3 days for Met 2000 mg.|||participants|||Number
795764|NCT00918138|Other Pre-specified|Participants With Confirmed Hypoglycemia Events During the Treatment Period|'Confirmed' = recorded on the hypoglycemia AE case report form with a fingerstick for glucose <= 50 mg/dL and associated symptoms.|AEs: up to last treatment day (LTD) +1 day or last visit day (LVD), whichever came last ; SAEs: up to LTD +30 days or LVD + 30 days, whichever came last. Mean duration of exposure=27.7 days for Saxa 5 mg + Met XR 1500 mg, and 28.3 days for Met 2000 mg.|Treated participants||participants|||Number
795765|NCT00918138|Secondary|Change From Baseline Fasting Plasma Glucose (FPG) at Week 4, Obtained Immediately Before the Morning Meal|FPG measurements were done at baseline, day 14 and 28. At baseline and day 28, the FPG value=plasma glucose value collected 30 minutes prior to the morning meal during the domicile visit.|Baseline, Week 4|Randomized participants who had both baseline and Week 4 assessments. Last Observation Carried Forward (LOCF).||mg/dL||Standard Error|Mean
795766|NCT00918138|Secondary|Change From Baseline to Week 4 in 2-hour Postprandial Glucose (PPG) (2 Hours After the Evening Meal)|Adjusted mean change from baseline in 2-hour postprandial (after mealtime) plasma glucose two hours after start of the evening meal during 24-hour domicile visits evaluated both at pre-randomization (baseline) and at Week 4. Mean change from baseline was adjusted for baseline value.|Baseline, Week 4|Randomized participants who had both baseline and Week 4 assessments.||mg/dL||Standard Error|Mean
795821|NCT00918736|Secondary|the Level of Global Satisfaction Based on a 7-point Categorical Scale|The rating was based on a 7-point categorical scale weighted from completely satisfied, satisfied, somewhat satisfied, no change, somewhat unsatisfied, unsatisfied to completely unsatisfied.|6 months||10/2009||||
823263|NCT01170546|Primary|Age||before training|||year||Standard Deviation|Mean
795767|NCT00918138|Primary|Change From Baseline in 24-Hour Mean Weighted Glucose (MWG) at Week 4|Adjusted mean change from baseline in MWG achieved with saxagliptin 5 mg plus metformin XR versus placebo plus metformin XR at Week 24. MWG was calculated as the area under the curve (AUC) for the full 24 hours expressed as average mg/dL. Glucose measurements were collected 30 minutes before and just prior to each meal (0 minutes) and 30, 60, 120, and 180 minutes after each meal (with 1 additional measurement at 240 minutes after the evening meal), midnight, 3 AM, and at end-of-domicile visit 24 hours after the first measurement. Mean change from baseline was adjusted for baseline value.|Baseline, Week 4|Randomized participants who had both baseline and Week 4 assessments.||mg/dL||Standard Error|Mean
795768|NCT00918203|Secondary|PK - Steady State Volume of Distribution (Vss) of Olaratumab||Cycle 3, Day 1: Predose, 30 min, 1.5 hrs, 24,48,96,168 Hrs Post Dose|All randomized participants who received any dose of study drug and had evaluable PK data in Cycle 3 first dose.||Liter (L)||Geometric Coefficient of Variation|Geometric Mean
795769|NCT00918203|Secondary|PK - Clearance (Cl) of Olaratumab||Cycle 3, Day 1: Predose, 30 min, 1.5 hr, 24,48,96,168 Hrs Post Dose|All randomized participants who received any dose of study drug and had evaluable PK data in Cycle 3 first dose.||Liter/hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
795770|NCT00918203|Secondary|PK - Half-Life (t1/2) of Olaratumab||Cycle 3, Day 1: Predose, 30 min, 1.5 hrs, 24,48,96,168 Hrs Post Dose|All randomized participants who received any dose of study drug and had evaluable PK data in Cycle 3 first dose. PK data was not analyzed in the paclitaxel + carboplatin arm or the crossover to olaratumab arm.||days||Full Range|Geometric Mean
795771|NCT00918203|Secondary|PK - Maximum Concentration (Cmax) of Olaratumab||Cycle 3, Day 1: Predose, 30 min, 1.5 hrs, 24,48,96,168 Hrs Post Dose|All randomized participants who received any dose of study drug and had evaluable PK data in Cycle 3 first dose. PK data was not analyzed in the paclitaxel + carboplatin arm or the crossover to olaratumab arm.||micrograms/milliliter (ug/mL)||Geometric Coefficient of Variation|Geometric Mean
795772|NCT00918203|Secondary|Pharmacokinetics (PK) - Area Under the Curve (AUC) 0-168 of Olaratumab|AUC(0-168) = area under the concentration versus time curve from time zero to 168 hours post dose.|Cycle 3, Day 1: Predose, 30 minutes (min), 1.5 hours (hrs), 24,48,96,168 Hrs Post Dose|All randomized participants who received any dose of study drug and had evaluable PK data in Cycle 3. PK data was not analyzed in the paclitaxel + carboplatin arm or the crossover to olaratumab arm.||microgram*hour/milliliter (ug*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
795773|NCT00918203|Secondary|Percentage of Participants With Anti-Olaratumab Antibodies|Participants with Treatment Emergent (TE) anti-olaratumab antibodies were participants with a 4-fold increase (2 dilutions) increase over a positive baseline antibody titer or for a negative baseline titer, a participant with an increase from the baseline to a level of 1:20.|Baseline to Study Completion (Up to 8 Months)|All randomized participants who had baseline and post baseline Anti-Olaratumab antibodies. Those participants who did not meet eligibility criteria were not included in this assessment.||percentage of participants|||Number
795774|NCT00918203|Secondary|Pharmacodynamics of Olaratumab|Pharmacodynamics of Olaratumab was determined by analysis of pharmacodynamic markers vascular endothelial growth factor (VEGF) and platelet derived growth factor (PDGF).|Cycle 1: Days 1, 8, and 15 pre- and post-infusion of Olaratumab; Cycles 2-6: day 1 only, pre- and post-infusion of Olaratumab|No data was available due to the collection of plasma samples was not fit for the assessment of PDGFs, as the collection procedure did not prevent platelet activation resulting in elevated levels of PDGFs in the circulation. Pharmacodynamics data was not analyzed in the paclitaxel + carboplatin arm or the crossover to olaratumab arm.|||||
795775|NCT00918203|Secondary|Median Duration of Response|The duration of overall response is measured from the time measurement criteria are first met for Complete Response (CR)/Partial Response (PR) (whichever is first recorded) until the first date that the criteria for PD are met (taking as a reference for PD the smallest measurement recorded since the treatment started), initiation of other/additional antitumor therapy is first reported, or death, is objectively documented.|First Criteria Met for CR or PR to Measured PD Start of Other Antitumor Therapy or Death From Any Cause (Up to 31 Months)|All randomized participants who received any dose of study drug and had achieved tumor response of CR or PR. Median Duration of Response data was not analyzed in the crossover olaratumab arm.||weeks||95% Confidence Interval|Median
795776|NCT00918203|Secondary|Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) Objective Tumor Response Rate (ORR)|The ORR is equal to the percentage of participants achieving a best overall response of partial response or complete response (PR + CR), according to RECIST version 1.1 criteria. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes must have reduction in short axis to <10 millimeter (mm) and normalization of tumor marker level of non-target lesions; PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions; PD was defined as having at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase above nadir; Stable Disease (SD) was defined as small changes that did not meet above criteria. Participants who had no post baseline tumor assessments were considered non-responders and included in the denominator when calculating response rate. Percentage of participants=(number of participants with CR+PR/total number of participants)*100.|Baseline to Measured PD or Study Discontinuation (Up to 31 Months)|All randomized participants who received any dose of study drug.||percentage of participants||95% Confidence Interval|Number
795777|NCT00918203|Secondary|Overall Survival (OS)|Overall survival is defined as the time from date of randomization to the date of death from any cause. If the participant is alive at the end of the follow-up period or is lost to follow-up, OS was censored on the last date the participants is known to be alive.|Baseline to Death From Any Cause (Up to 31 Months)|All randomized participants who received any dose of study drug. OS data was not analyzed in the crossover olaratumab arm. Participants censored: olaratumab + paclitaxel + carboplatin = 19 and paclitaxel + carboplatin = 20.||weeks||95% Confidence Interval|Median
795778|NCT00918203|Secondary|Safety and Tolerability of Olaratumab Administered at a More Rapid Rate (25mg/Min With Minimum Infusion Time of 30 Minutes), Determined by Number of Participants With Treatment Related Adverse Events||Up to 43 Months|All randomized participants who received any dose of study drug.||participants|||Number
795779|NCT00918203|Secondary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.|Baseline to Study Completion (Up to 43 Months)|All randomized participants who received any dose of study drug.||participants|||Number
795780|NCT00918203|Primary|Progression-Free Survival (PFS)|PFS is defined as the time from the day of randomization to the first evidence of progression by RECIST version 1.1, or death from any cause. Participants who died without a reported prior progression were considered to have progressed on the day of their death. Participants who did not progress and were subsequently lost to follow-up had their data censored at the day of their last tumor assessment. If there was no radiologic assessment at baseline or post baseline, participants were censored at the date of randomization. If death or progressive disease (PD) occurred after 2 or more consecutive missing radiographic visits, censoring occurred at the date of the last radiographic visit prior to the missed visits.|Baseline to Measured PD or Death From Any Cause (Up to 31 Months)|All randomized participants who received any dose of study drug. Participants censored: paclitaxel + carboplatin = 13, olaratumab + paclitaxel + carboplatin = 20, and crossover to olaratumab = 4.||weeks||95% Confidence Interval|Median
795781|NCT00918255|Secondary|Percent Change From Baseline in Number of All Inflammatory Nodules and Plaques at Week 52|Includes inflammatory nodules that are tender, erythematous, and have diameters less than 5 cm and includes plaques that have diameters greater than or equal to 5 cm. Range for percent change is negative infinity to infinity. Negative percent changes from Baseline indicate improvement.|Baseline, Week 52||||||
795782|NCT00918255|Secondary|Change From Baseline in Modified Sartorius Scale at Week 52|The Modified Sartorius Scale reflects changes in hidradenitis suppurative symptoms, namely the number of lesions (abscesses, nodules, and fistulas) and the longest distance between lesions. A total score is derived based on assessments at up to 8 distinct anatomical regions and ranges from 5 to indefinite. Smaller numbers are better scores and indicate less lesion involvement, thus decreases (negative changes) from baseline indicate improvement in severity of disease.|Baseline, Week 52||||||
795783|NCT00918255|Secondary|Change From Baseline in Modified Sartorius Scale at Week 16|The Modified Sartorius Scale reflects changes in hidradenitis suppurative symptoms, namely the number of lesions (abscesses, nodules, and fistulas) and the longest distance between lesions. A total score is derived based on assessments at up to 8 distinct anatomical regions and ranges from 5 to indefinite. Smaller numbers are better scores and indicate less lesion involvement, thus decreases (negative changes) from baseline indicate improvement in severity of disease.|Baseline, Week 16|Population was Intent-to-treat (ITT). Imputation method was Last Observation Carried Forward (LOCF).||scores on a scale||Inter-Quartile Range|Median
795784|NCT00918255|Secondary|Percentage of Participants Achieving Clinical Response at Week 12|Clinical response is defined as a Physician's Global Assessment (PGA) of clear, minimal, or mild (scores of 0, 1, or 2) with a minimum of 2 grades improvement (reduction) from baseline. PGA is a physician's assessment of the severity of disease based on a 6-point scale (score of 0 = clear and 5 = very severe).|Baseline, Week 12|Intent-to-treat analysis with non-responder imputation (participants with missing PGA scores counted as non-responders).||percentage of participants|||Number
795785|NCT00918255|Secondary|Percentage of Participants Achieving Clinical Response at Week 8|Clinical response is defined as a Physician's Global Assessment (PGA) of clear, minimal, or mild (scores of 0, 1, or 2) with a minimum of 2 grades improvement (reduction) from baseline. PGA is a physician's assessment of the severity of disease based on a 6-point scale (score of 0 = clear and 5 = very severe).|Baseline, Week 8|Intent-to-treat analysis with non-responder imputation (participants with missing PGA scores counted as non-responders).||percentage of participants|||Number
795786|NCT00918255|Secondary|Percentage of Participants Achieving Clinical Response at Week 4|Clinical response is defined as a Physician's Global Assessment (PGA) of clear, minimal, or mild (scores of 0, 1, or 2) with a minimum of 2 grades improvement (reduction) from baseline. PGA is a physician's assessment of the severity of disease based on a 6-point scale (score of 0 = clear and 5 = very severe).|Baseline, Week 4|Intent-to-treat analysis with non-responder imputation (participants with missing PGA scores counted as non-responders).||percentage of participants|||Number
795787|NCT00918255|Secondary|Percentage of Participants Achieving Clinical Response at Week 2|Clinical response is defined as a Physician's Global Assessment (PGA) of clear, minimal, or mild (scores of 0, 1, or 2) with a minimum of 2 grades improvement (reduction) from baseline. PGA is a physician's assessment of the severity of disease based on a 6-point scale (score of 0 = clear and 5 = very severe).|Baseline, Week 2|Intent-to-treat analysis with non-responder imputation (participants with missing PGA scores counted as non-responders).||percentage of participants|||Number
795788|NCT00918255|Secondary|Percent Change From Baseline in Number of All Inflammatory Nodules and Plaques at Week 16|Includes inflammatory nodules that are tender, erythematous, and have diameters less than 5 cm and includes plaques that have diameters greater than or equal to 5 cm. Range for percent change is negative infinity to infinity. Negative percent changes from Baseline indicate improvement.|Baseline, Week 16|Population was Intent-to-treat (ITT) and included participants with any inflammatory nodules (defined as tender, erythematous) or plaques at Baseline. Imputation method was Last Observation Carried Forward (LOCF).||percent change||Standard Error|Least Squares Mean
795789|NCT00918255|Primary|Percentage of Participants Achieving Clinical Response at Week 16|Clinical response is defined as a Physician's Global Assessment (PGA) of clear, minimal, or mild (scores of 0, 1, or 2) with a minimum of 2 grades improvement (reduction) from baseline. PGA is a physician's assessment of the severity of disease based on a 6-point scale (score of 0 = clear and 5 = very severe).|Baseline, Week 16|Intent-to-treat analysis with non-responder imputation (participants with missing PGA scores counted as non-responders).||percentage of participants|||Number
795790|NCT00918281|Secondary|The Safety of Greater Than or Equal to 2 Administrations, Each of a Maximum of 370MBq, Fluciclatide Injection (AH111585 (18F) Injection) in Subjects With Solid Primary or Metastatic Tumors.|Safety was monitored throughout the duration of the subject’s participation.|Up to 8 weeks post contrast administration.|The variable is looking at the Overall Summary of Treatment-Emergent Adverse Events (TEAE). Subjects could have experienced more than one TEAE. The category titles refer to Severe Adverse Events(SAE) and Adverse Events (AE).||number of adverse events|||Number
795791|NCT00918281|Primary|Test Image and Retest Image Reproducibility of Fluciclatide Injection ([18F]AH111585) Uptake by Solid Tumors Following Intravenous Administration of AH111585 (18F) Injection Via PET Imaging.|Mean relative differences of Standardized uptake value (SUV) following intravenous administration of AH111585 (F18) Injection between the two PET imaging sessions.|Forty minutes, 65 minutes and 90 minutes post Fluciclatide administration.|Subjects received 2 doses of Fluciclatide Injection (AH111585 (18F) Injection).||Standardized Uptake Value||Standard Deviation|Mean
795792|NCT00918346|Primary|Primary Pharmacodynamic Variable Per Protocol Efficacy Dataset: Change From Baseline in the Overall Diurnal Intraocular Pressure (IOP) at Week 4 (Worse Eye)|Overall treatment difference at 4 weeks (unpreserved-preserved) evaluated using a repeated measurments analysis of covariance (RM ANCOVA) model.|Baseline - Week 4|Per Protocol (PP): randomized patients who completed the study per protocol (i.e. excluded from PP is the discontinued patient and a patient with major protocol violation)||mmHg||95% Confidence Interval|Mean
795793|NCT00918346|Primary|Primary Pharmacodynamic Variable Intention to Treat Efficacy Dataset: Change From Baseline in the Overall Diurnal Intraocular Pressure (IOP) at Week 4 (Worse Eye)|Overall treatment difference at 4 weeks (unpreserved-preserved) evaluated using a repeated measurements analysis of covariance (RM ANCOVA) model.|Baseline - Week 4|Intention To Treat (ITT): randomized patients who received at least one dose of study medication and had at least one pharmacodynamic (IOP) measurement available.||mmHg||95% Confidence Interval|Mean
795794|NCT00918346|Primary|Intraocular Pressures (IOPs) at Week 4|IOPs at week 4: mean IOP values at four timepoints (worse eye)|Week 4|IOPs of all subjects who received preserved/unpreserved formulation||mmHg||Standard Deviation|Mean
795795|NCT00918346|Primary|Intraocular Pressures (IOPs) at Week 1|IOPs at week 1: mean IOP values at four timepoints (worse eye)|Week 1|IOPs of all subjects who received preserved/unpreserved formulation||mmHg||Standard Deviation|Mean
795796|NCT00918346|Secondary|Change From Baseline in Time-wise IOPs at Week 4|The time-wise, i.e. at 8:00, 12:00, 16:00 and 20:00, comparisons of IOP at week 4 (IOP value at given timepoint at 4 weeks minus corresponding value at baseline: unpreserved-preserved) were done using the RM ANCOVA model.|Baseline - Week 4|ITT: randomized patients who received at least one dose of study medication and had at least one pharmacodynamic (IOP) measurement available.||mmHg||95% Confidence Interval|Mean
795797|NCT00918346|Secondary|Overall and Time-wise Comparisons of IOP at Week 1|The overall and time-wise, i.e. at 8:00, 12:00, 16:00 and 20:00, comparisons of IOP at week 1 (diurnal IOP and IOP value at given timepoint at 1 week minus corresponding value at baseline: unpreserved-preserved) were done using the RM ANCOVA model.|Baseline - Week 1|ITT: randomized patients who received at least one dose of study medication and had at least one pharmacodynamic (IOP) measurement available.||mmHg||95% Confidence Interval|Mean
795798|NCT00918346|Primary|Intraocular Pressures (IOPs) at Baseline|IOPs at baseline: mean IOP values at four timepoints (worse eye)|Baseline|IOPs of all subjects who received preserved/unpreserved formulation||mmHg||Standard Deviation|Mean
795799|NCT00918385|Secondary|Overall Response Rate of Men With Low AR Activity|Tumor response is based on Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Partial response (PR) is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|During dasatinib monotherapy ( at least 12 weeks)|Of the 17 subjects treated, 15 had response documentation and are included in the calculation. Two were omitted (1 because response documentation was not provided; 1 ended treatment after 2 weeks for toxicity prior to repeat scans).||percentage of patients with CR,PR||95% Confidence Interval|Number
795800|NCT00918385|Secondary|Overall Response Rate of Men With High AR Activity|Tumor response was based on Response Criteria in Solid Tumors (RECIST). Complete response (CR) is defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Partial response (PR) is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|During monotherapy (at least 12 weeks)|14 subjects began treatment; 13 with response documentation are included in the calculation; 1 subject was omitted because response documentation was not provided.||percentage of patients with CR,PR||95% Confidence Interval|Number
795801|NCT00918385|Primary|Progression Free Survival (PFS)|PFS is the interval from start of monotherapy until first disease progression or death, whichever occurred first.|During monotherapy ( at least 12 weeks)|||months||90% Confidence Interval|Median
795802|NCT00918580|Other Pre-specified|Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 2|Specific systemic events (fever >=38 degrees C, vomiting, diarrhea, headache, fatigue, muscle pain, joint pain, and use of antipyretic medications) were prompted for each day, and reported using an electronic diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any(symptom present); Mild(did not interfere with activity); Moderate(some interference); Severe(prevented routine daily activity). Vomiting was scaled as: Any(vomiting present); Mild(1-2 times in 24 hours); Moderate(>2 times in 24 hours); Severe (required intravenous hydration). Diarrhea was scaled as: Any(diarrhea present); Mild(2-3 loose stools in 24 hours); Moderate(4-5 loose stools 24 hours); Severe(>=6 loose stools in 24 hours). Here number of participants analyzed signifies the safety population for Dose 2 and “N” signifies those participants who reported “Yes” for at least 1 day or “No” for all days for specified systemic event. Participants may be represented in more than 1 category.|Within 7 days after 13vPnC Dose 2|Safety population for Dose 2 included all participants who received Dose 2 of study vaccine and had safety data available.||percentage of participants|||Number
795803|NCT00918580|Other Pre-specified|Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 1|Specific systemic events (fever >=38 degrees Celsius[C], vomiting, diarrhea, headache, fatigue, muscle pain, joint pain, use of antipyretic medications) were prompted for each day and reported using an electronic diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any(symptom present); Mild(did not interfere with activity); Moderate(some interference); Severe(prevented routine daily activity). Vomiting was scaled as: Any(vomiting present); Mild(1-2 times in 24 hours); Moderate(>2 times in 24 hours); Severe(required intravenous hydration). Diarrhea was scaled as: Any(diarrhea present); Mild(2-3 loose stools in 24 hours);Moderate(4-5 loose stools 24 hours); Severe(>=6 loose stools in 24 hours). Here number of participants analyzed signifies the safety population for Dose 1 and “N” signifies those participants who reported “Yes” for at least 1 day or “No” for all days for specified systemic event. Participants may be represented in more than 1 category.|Within 7 days after 13vPnC Dose 1|Safety population for Dose 1 included all participants who received Dose 1 of study vaccine and had safety data available.||percentage of participants|||Number
795822|NCT00918736|Secondary|Four Clinical Balance Tests|Single-leg stance test (SLS),The Functional Reach Test (FRT),Timed “ Up-and-Go” test (TUG) ,Berg Balance Scale (BBS)|6 months||09/2009||||
795823|NCT00918736|Secondary|Ankle Sagittal Range of Motion|Ankle sagittal ROM is the sum of ankle dorsiflexion and plantar flexion angles.|6 months||09/2009||||
795804|NCT00918580|Other Pre-specified|Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 2|Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as: Any (redness present or swelling present); Mild (<2.5 cm for participants aged 6 to <12 years and 2.5 to 5.0 cm for participants aged >=12 years); Moderate (2.5 to 7.0 cm for participants aged 6 to <12 years and 5.1 to 10.0 cm for participants aged >=12 years); Severe (>7 cm for participants aged 6 to <12 years and >10 cm for participants aged >=12 years). Pain was scaled as: Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity). Here number of participants analyzed signifies the safety population for Dose 2 and “N” signifies those participants who reported “Yes” for at least 1 day or “No” for all days for specified local reaction. Participants may be represented in more than 1 category.|Within 7 days after 13vPnC Dose 2|Safety population for Dose 2 included all participants who received Dose 2 of study vaccine and had safety data available.||percentage of participants|||Number
795805|NCT00918580|Other Pre-specified|Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 1|Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as: Any (redness present or swelling present); Mild (less than <2.5 centimeters [cm] for participants aged 6 to <12 years and 2.5 to 5.0 cm for participants aged greater than or equal to [>=] 12 years); Moderate (2.5 to 7.0 cm for participants aged 6 to <12 years and 5.1 to 10.0 cm for participants aged >=12 years); Severe (>7 cm for participants aged 6 to <12 years and >10 cm for participants aged >=12 years). Pain was scaled as: Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity). Here “Number of participants analyzed” signifies the safety population for Dose 1 and “N” signifies those participants who reported “Yes” for at least 1 day or “No” for all days for specified local reaction. Participants may be represented in more than 1 category.|Within 7 days after 13vPnC Dose 1|Safety population for Dose 1 included all participants who received Dose 1 of study vaccine and had safety data available.||percentage of participants|||Number
795806|NCT00918580|Secondary|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Year After 13vPnC Dose 2|"Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). GMT and corresponding 2-sided 95% CIs were evaluated. CIs for the GMTs are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the titers. GMTs were calculated using all participants with available data for the specified blood draw. Here number of participants analyzed signifies the evaluable immunogenicity population at 1-year follow-up and N signifies participants with determinate OPA antibody titer for the given serotype. Participants may be represented in more than 1 category."|1 year after 13vPnC Dose 2|Evaluable immunogenicity population at 1-year follow-up: eligible participants who received all study vaccinations; had valid and determinate assay result; had blood drawn within pre-specified time-frames; had no major protocol violation (including use of prohibited vaccine/medication, immunoglobulins or chronic systemic corticosteroids).||titer||95% Confidence Interval|Geometric Mean
795807|NCT00918580|Secondary|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)|"Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). GMT and corresponding 2-sided 95% CIs were evaluated. CIs for the GMTs are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the titers. GMTs were calculated using all participants with available data for the specified blood draw. Here number of participants analyzed signifies the evaluable immunogenicity population and N signifies participants with determinate OPA antibody titer for the given serotype at specified time point. Participants may be represented in more than 1 category."|Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1, before 13vPnC Dose 2, 1 month after 13vPnC Dose 2|Evaluable immunogenicity population: eligible participants who received all study vaccinations; had valid and determinate assay result; had blood drawn within pre-specified time-frames; had no major protocol violation (including use of prohibited vaccine/medication, immunoglobulins or chronic systemic corticosteroids).||titer||95% Confidence Interval|Geometric Mean
795808|NCT00918580|Secondary|Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Year After 13vPnC Dose 2|"Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated. Geometric means were calculated using all participants with available data for the specified blood draw. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Here number of participants analyzed signifies the evaluable immunogenicity population at 1-year follow-up and N signifies participants with determinate IgG antibody concentration for the given serotype. Participants may be represented in more than 1 category."|1 year after 13vPnC Dose 2|Evaluable immunogenicity population at 1-year follow-up: eligible participants who received all study vaccinations; had valid and determinate assay result; had blood drawn within pre-specified time-frames; had no major protocol violation (including use of prohibited vaccine/medication, immunoglobulins or chronic systemic corticosteroids).||mcg/mL||95% Confidence Interval|Geometric Mean
795809|NCT00918580|Secondary|Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody|"Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated. Geometric means were calculated using all participants with available data for the specified blood draw. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Here number of participants analyzed signifies the evaluable immunogenicity population and N signifies participants with determinate IgG antibody concentration for the given serotype at specified time point. Participants may be represented in more than 1 category."|Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1, before 13vPnC Dose 2, 1 month after 13vPnC Dose 2|Evaluable immunogenicity population: eligible participants who received all study vaccinations; had valid and determinate assay result; had blood drawn within pre-specified time-frames; had no major protocol violation (including use of prohibited vaccine/medication, immunoglobulins or chronic systemic corticosteroids).||microgram per milliliter (mcg/mL)||95% Confidence Interval|Geometric Mean
795868|NCT00919126|Secondary|Serum Chemistry - AST (GOT) (IU/L)|AST (GOT) (IU/L) obtained from blood samples collected at baseline and in Morning following surgery.|1 Postoperative Day|The analysis was done in the ITT Data Set (Randomised Patients).||IU/L||Standard Deviation|Mean
795810|NCT00918580|Secondary|Ratio of Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 13vPnC Dose 1 to 13vPnC Dose 2|"GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were computed using the logarithmically transformed assay results for Dose 1 (after Dose 1/before Dose 1) and for Dose 2 (after Dose 2/before Dose 2). CI for the ratio of GMFR (Dose 2/Dose 1) were back transformations of a CI based on the Student t distribution for the mean logarithm of the measures (Dose 2 – Dose 1). Here number of participants analyzed signifies the evaluable immunogenicity population and N signifies participants with determinate IgG antibody concentration for given serotype at before 13vPnC Dose 1, 1 month after 13vPnC Dose 1, before 13vPnC Dose 2 and 1 month after 13vPnC Dose 2 blood draws. Participants may be represented in more than 1 category."|Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1, before 13vPnC Dose 2, 1 month after 13vPnC Dose 2|Evaluable immunogenicity population: eligible participants who received all study vaccinations; had valid and determinate assay result; had blood drawn within pre-specified time-frames; had no major protocol violation (including use of prohibited vaccine/medication, immunoglobulins or chronic systemic corticosteroids).||ratio of GMFR||95% Confidence Interval|Geometric Mean
795811|NCT00918580|Secondary|Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 2 to 1 Month After 13vPnC Dose 2|"GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC Dose 2 to 1 month after 13vPnC Dose 2 were computed using the logarithmically transformed assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from before 13vPnC Dose 2 and 1 month after 13vPnC Dose 2 blood draws. Here number of participants analyzed signifies the evaluable immunogenicity population and N signifies participants with determinate IgG antibody concentration for the given serotype at both the before 13vPnC Dose 2 and 1 month after 13vPnC Dose 2 blood draws. Participants may be represented in more than 1 category."|Before 13vPnC Dose 2, 1 month after 13vPnC Dose 2|Evaluable immunogenicity population: eligible participants who received all study vaccinations; had valid and determinate assay result; had blood drawn within pre-specified time-frames; had no major protocol violation (including use of prohibited vaccine/medication, immunoglobulins or chronic systemic corticosteroids).||fold rise||95% Confidence Interval|Geometric Mean
795812|NCT00918580|Secondary|Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1|"GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC Dose 1 to 1 month after 13vPnC Dose 1 were computed using the logarithmically transformed assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from before 13vPnC Dose 1 and 1 month after 13vPnC Dose 1 blood draws. Here number of participants analyzed signifies the evaluable immunogenicity population and N signifies participants with determinate IgG antibody concentration for the given serotype at both the before 13vPnC Dose 1 and 1 month after 13vPnC Dose 1 blood draws. Participants may be represented in more than 1 category."|Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1|Evaluable immunogenicity population: eligible participants who received all study vaccinations; had valid and determinate assay result; had blood drawn within pre-specified time-frames; had no major protocol violation (including use of prohibited vaccine/medication, immunoglobulins or chronic systemic corticosteroids).||fold rise||95% Confidence Interval|Geometric Mean
795813|NCT00918580|Primary|Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 1 Month After 13vPnC Dose 1 to 1 Month After 13vPnC Dose 2|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 1 to 1 month after 13vPnC Dose 2 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both 1 month after 13vPnC Dose 1 and after 13vPnC Dose 2 blood draws. Here number of participants analyzed signifies the evaluable immunogenicity population and “N” signifies participants with a determinate IgG antibody concentration for the given serotype at both 1 Month After 13vPnC Dose 1 and 1 Month After 13vPnC Dose 2 blood draws. Participants may be represented in more than 1 category.|1 Month After 13vPnC Dose 1, 1 Month After 13vPnC Dose 2|Evaluable immunogenicity population: eligible participants who received all study vaccinations; had valid and determinate assay result; had blood drawn within pre-specified time-frames; had no major protocol violation (including use of prohibited vaccine/medication, immunoglobulins or chronic systemic corticosteroids).||fold rise||95% Confidence Interval|Geometric Mean
795814|NCT00918671|Secondary|Change of Medication Days/Month Compared to Baseline||Baseline and after 4 years' of follow-up|||medication days/month||Standard Deviation|Mean
795815|NCT00918671|Primary|Change in Headache Days/Month After 4 Years Compared to Baseline|Change in headache days/month after 4 years compared to baseline|Baseline and after 4 years|||headache days/month||Standard Deviation|Mean
795816|NCT00918684|Primary|Stroop Color-Word Test|A published and widely used executive dysfunction test, the Stroop Color-Word total scores can range from 0-100. Higher scores indicate better memory functioning (no cognitive impairment). Total scores are reported with no subscales.|14 weeks (12th week of treatment)|||units on a scale||Standard Deviation|Mean
795817|NCT00918684|Primary|WHODAS-II Disability Scale|A disability rating scale published by the World Health Organization, the WHODAS II total scores can range from 0-100. Higher scores indicate greater severity of disability. Total scores are reported with no subscales.|14 weeks (12th week of treatment)|||units on a scale||Standard Deviation|Mean
795818|NCT00918684|Primary|Hamilton Depression Rating Scale.|A published and widely-used scale for rating depression severity, the Hamilton Depression Rating Scale 24 item total scores range from 0-76. Higher scores indicate greater severity of depression. Total scores are reported with no subscales.|14 weeks (12th week of treatment)|||units on a scale||Standard Deviation|Mean
795819|NCT00918736|Secondary|Rescue Acetaminophen Consumption|The use of all analgesic medication during the study period was recorded on a diary card by the patient.|6 months||10/2009||||
795820|NCT00918736|Secondary|Systemic and Local Adverse Events Recording|he occurrence of systemic and local adverse events, defined as any unwanted events whether it was thought to be related to the study drugs or not, were recorded on a diary card|6 months||10/2009||||
795825|NCT00918736|Primary|Change From Baseline in the Ankle Osteoarthritis Scale (AOS) Score at 6 Months|The AOS is a patient-rated, validated outcome measure that includes nine items on a pain subscale and nine items on a disability subscale. Using the AOS, a score of 0 represent no pain or disability and 10 represent worst pain or disability imaginable|baseline and 6 months|The statistical analysis was done on completers.||score on a scale||Standard Deviation|Mean
795826|NCT00918749|Secondary|Serum BAP Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 4, ITT Population|ITT Population|4 months|ITT Population||Percent Change from Baseline||Standard Error|Least Squares Mean
795827|NCT00918749|Secondary|Serum BAP Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 3, ITT Population|ITT Population|3 months|ITT Population||Percent Change from Baseline||Standard Error|Least Squares Mean
795828|NCT00918749|Secondary|Serum Bone Specific Alkaline Phosphatase (BAP) Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 2, ITT Population|ITT Population|2 months|ITT Population||Percent Change from Baseline||Standard Error|Least Squares Mean
795829|NCT00918749|Secondary|Percent Change From Baseline Urine NTX Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 4, ITT Population|ITT Population|4 months|ITT Population||Percent Change from Baseline||Standard Error|Least Squares Mean
795830|NCT00918749|Secondary|Percent Change From Baseline Urine NTX Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 3, ITT Population|ITT Population|3 months|ITT Population||Percent Change from Baseline||Standard Error|Least Squares Mean
795831|NCT00918749|Secondary|Percent Change From Baseline Urine NTX (Type-1 Collagen Cross-linked N-telopeptide) Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 2, ITT Population|Urine NTX Bone turnover marker collected after 8 hour fast, 2nd voided urine between 6-9 am assayed by ELISA.|2 months|ITT Population||Percent Change from Baseline||Standard Error|Least Squares Mean
795832|NCT00918749|Secondary|Percent Change From Baseline CTX 150 mg IRBB Tablet Compared With 75 mg & 100 mg DRFB Tablet, Month 3, ITT Population||3 months|ITT Population||Percent Change from Baseline||Standard Error|Least Squares Mean
795833|NCT00918749|Secondary|Percent Change From Baseline CTX 150 mg IRBB Tablet Compared With 75 mg & 100 mg DRFB Tablet, Month 2, ITT Population||2 months|ITT Population||Percent Change from Baseline||Standard Error|Least Squares Mean
795834|NCT00918749|Primary|Percentage Change From Baseline Serum Type-1 Collagen C-telopeptide (CTX) 75 mg & 100 mg DRFB Tablet Compared With 150 mg IRBB Tablet, Month 4, ITT Population|Fasting serum Bone turn-over marker specimen assayed by electochemiluminescence.|Month 4|ITT Population||Percent Change from Baseline||Standard Error|Least Squares Mean
795835|NCT00918866|Secondary|Immunology Panel- Tryptase|Evaluate the Immunology Panel after the administration of DEFINITY|Out to 70 minutes|||ug/ml||Standard Deviation|Mean
795836|NCT00918866|Secondary|Immunology Panel- Interleuken-6|Evaluate the Immunology Panel after the administration of DEFINITY|Out to 70 minutes|||pg/ml||Standard Deviation|Mean
795837|NCT00918866|Secondary|Immunology Panel- Complement 5A(C5A)|Evaluate the Immunology Panel after the administration of DEFINITY|Out to 70 minutes|||ng/ml||Standard Deviation|Mean
795838|NCT00918866|Secondary|Immunology Panel- Complement 3A (C3A)|Evaluate the Immunology Panel after the administration of DEFINITY|Out to 70 minutes|||ng/ml||Standard Deviation|Mean
795839|NCT00918866|Primary|Percent Change in Pulmonary Artery Pressure Change From 1 Minute Pre-dose to 31 - 35 Minutes Post Dose|Percent change in pulmonary atery pressure change from immediately pre-dose to 31 - 35 minutes post dose|31-35 minutes minus baseline|Per the protocol||mm Hg||Standard Deviation|Mean
795840|NCT00918879|Secondary|Proportion of Patients (Expressed in Percentage of Total Participants) Achieving a Therapeutic Glycemic Response Defined as HbA1c < 7.0% at Week 24|Proportion of participants (expressed in percentage of total participants)achieving HbA1c < 7.0% for saxagliptin versus placebo at Week 24 (LOCF, Full Analysis set). HbA1c data were excluded on and after rescue medication|Baseline , Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Wk 24(LOCF) for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. If participant received rescue medication, that measurement must have been taken before rescue.||Percentage of Participants|||Number
795841|NCT00918879|Secondary|Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG)|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg versus placebo at Week 24 (LOCF, Full Analysis set). FPG is a continuous measure, the change from baseline for each subject is calculated as the Week 24 values minus the baseline value. FPG data were excluded on and after rescue medication.|Baseline , Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Wk 24(LOCF) for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. If participant received rescue medication, that measurement must have been taken before rescue.||mmol/L||Standard Error|Mean
795842|NCT00918879|Secondary|Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG)|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg versus placebo at Week 24 (LOCF, Full Analysis set). FPG is a continuous measure, the change from baseline for each subject is calculated as the Week 24 values minus the baseline value. FPG data were excluded on and after rescue medication.|Baseline , Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Wk 24(LOCF) for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. If participant received rescue medication, that measurement must have been taken before rescue.||mg/dL||Standard Error|Mean
795843|NCT00918879|Primary|Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c)|Adjusted* mean change from baseline in glycosylated haemoglobin A1c (HbA1c) achieved with saxagliptin 5 mg versus placebo at Week 24 (LOCF, Full Analysis set). HbA1c is a continuous measure, the change from baseline for each subject is calculated as the Week 24 values minus the baseline value. HbA1c data were excluded on and after rescue medication.|Baseline , Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Wk 24(LOCF) for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. If participant received rescue medication, that measurement must have been taken before rescue.||percent||Standard Error|Mean
796274|NCT00928408|Primary|Cinacalcet Dose|Cinacalcet dose at end of treatment (last dose received)|Up to Month 12|Full Analysis Set||mg/day||95% Confidence Interval|Mean
795844|NCT00918931|Primary|Response Rate|Response rate is defined as number of participants with objective response divided by number of participants evaluated. Objective response is complete response and partial response where 'complete response' constitutes total elimination of a symptom or sign of the disease; 'partial response' constitutes at least 50% improvement in a symptom or sign of the disease. Objective response definitions of response evaluated following guidelines proposed by Valent et al. (International working group consensus criteria).|3-Month Response Evaluation|Analysis was per protocol.||participants|||Number
795845|NCT00918957|Primary|Post-hoc: Relative Change From Baseline of Forced Expiratory Volume in One Second (FEV1) Percent Predicted to End of Dosing (Day 29) Without Outlier|Relative change in percentage predicted FEV1 without outlier (outliers with respect to FEV1 values and PK data), in the Intent-to-treat (ITT), modified ITT (mITT) and Observed cases in the ITT populations were calculated from an adjusted analysis ANOVA model.|Baseline, Day 29|ITT: All randomized patients (pts) received at least one dose of study drug. Missing or unacceptable Day 29 spirometry test -change from baseline FEV1 % predicted imputed using last available post-baseline value or 0. mITT: Pts with unacceptable FEV1 measurements excluded. Observed cases: Pts with missing or unacceptable FEV1 measurements excluded.||change in percentage||Standard Error|Least Squares Mean
795846|NCT00918957|Primary|Pre-planned Sensitivity Analysis: Absolute Change From Baseline of Forced Expiratory Volume in One Second (FEV1) Percent (%) Predicted to End of Dosing (Day 29)|"Absolute change in percentage predicted FEV1 in the Intent-to-treat (ITT), modified ITT (mITT) and Observed cases in the ITT populations were calculated from an adjusted analysis ANOVA model.
In the adjusted analysis model: response = treatment + screening FEV1 % predicted (<50 and >=50) + age (<13 and >=13) + error.
﻿Significance for the FEV1 % predicted is reached for p-values <= 0.05. There were 3 patients who had no screening nor baseline values (due to inadequate spirometry) and so were excluded from all change from baseline analyses."|Baseline, Day 29|ITT: All randomized patients (pts) received at least one dose of study drug. Missing or unacceptable Day 29 spirometry test -change from baseline FEV1 % predicted imputed using last available post-baseline value or 0. mITT: Pts with unacceptable FEV1 measurements excluded. Observed cases: Pts with missing or unacceptable FEV1 measurements excluded.||change in percentage||Standard Error|Least Squares Mean
795847|NCT00918957|Secondary|Tobramycin Serum Concentration|"Descriptive statistics of serum and sputum concentrations per scheduled sampling time.
Detectable concentration values at pre-dose on Day 1 were excluded from the analysis."|Pre-dose, 0 - 1 hour post-dose, 1 -2 hours post-dose, 2 - 6 hours post-dose|"Safety population: All randomized patients who received at least one dose of study drug. In all safety analyses patients were analyzed according to the treatment received.
This measures the concentration of active substance in the body at different time-point to evaluate there is abnormal accumulation of active substance. Not for Placebo Patients."||μ﻿g/mL||Standard Deviation|Mean
795848|NCT00918957|Secondary|Acute Change in Airways Reactivity (FEV1 Percent Predicted) From Pre-dose to 30 Minutes After Completion of First Dose of Study Drug|"Relative change = 100 * (30-m-post-dose - pre-dose)/pre-dose assessed by the number and percentage of patients with a decrease of ≥20 % in FEV1 % predicted from pre dose to 30 minutes post dose.
Day 1 is the scheduled visit of first study drug administration."|Day 1, Day 29|Safety population: All randomized patients who received at least one dose of study drug.In all safety analyses patients were analyzed according to the treatment received.||Percentage of participants|||Number
795849|NCT00918957|Secondary|Percentage of Participants With Serious Adverse Events (SAEs)|"Serious Adverse Events (on and off treatment) by preferred term and treatment group.
Preferred terms are sorted in descending order of frequency in the TIP treatment group.
A patient with multiple occurrences of the same preferred term is counted only once in the preferred term."|Time of consent, 4 weeks after study completion|Safety population: All randomized patients who received at least one dose of study drug. In all safety analyses patients were analyzed according to the treatment received.||percentage of participants|||Number
795850|NCT00918957|Secondary|Percentage of Participants With Adverse Events (AEs)|"Adverse Events (AEs) (on and off treatment) regardless of study relationship by primary system organ and treatment group.
Primary system organ classes are sorted in descending order of frequency in the TIP treatment group.
A patient with more than one AE within a primary system organ class is counted only once for that class."|First administration of study drug, study completion|Safety population: All randomized patients who received at least one dose of study drug.In all safety analyses patients were analyzed according to the treatment received||Percentage of participants|||Number
795851|NCT00918957|Secondary|Shift From Baseline in Laboratory Parameters to Above Upper/Lower Limit of Normal|"Hematology values shift from baseline to above upper/below lower limit of normal at any time post-baseline.
Biochemistry values shift from baseline to above upper/below lower limit of normal at any time post-baseline."|Baseline, Study completion|Safety population: All randomized patients who received at least one dose of study drug. In all safety analyses patients were analyzed according to the treatment received.||percentage of participants at risk|||Number
795852|NCT00918957|Secondary|Change From Baseline to End of Dosing (Day 29) and End of Off-cycle Period (Day 57) of Pseudomonas Aeruginosa Minimum Inhibitory Concentration (MIC)|Maximum MIC values from all biotypes were used. Absolute values and changes in tobramycin MIC for P. aeruginosa from baseline are summarized by biotype. Overall, a high variability of MIC was observed within each treatment group. For the maximum of all biotypes, large differences in mean changes from baseline at Day 29 were observed between the TIP group and the placebo group.|Baseline, Day 29, Day 57|Intent-to-treat (ITT) population: All randomized patients who received at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.||μg/mL||Standard Deviation|Mean
795853|NCT00918957|Secondary|Absolute Change From Baseline to End of Dosing (Day 29) and End of Off-cycle Period (Day 57) in Sputum Pseudomonas Aeruginosa Density (log10 Colony Forming Units(CFU) Per Gram Sputum)|"P. aeruginosa sputum density refers to overall density, defined as the sum of biotypes (mucoid, dry and small colony variant).
If sub-isolates exist for CFU biotype mucoid or dry, then the sum of sub-isolates is analyzed."|Baseline, Day 29, Day 57|﻿Intent-to-treat (ITT) population: All randomized patients who received at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.||Log10 CFU (colony forming unit)||Standard Error|Mean
795869|NCT00919126|Secondary|Haematology - Platelets (Giga/L)|Platelets (Giga/L) obtained from blood samples collected at baseline and in the morning following surgery|1 Postoperative Day|The analysis was done in the ITT Data Set (Randomised Patients).||Giga/L||Standard Deviation|Mean
795854|NCT00918957|Secondary|Change From Baseline of Forced Expiratory Flow Rate Over 25 and 75 Percent. (FEF25-75%) Predicted to End of Dosing (Day 29) and End of Off-cycle Period (Day 57)|"﻿FEF25-75: Forced expiratory flow rate over 25% to 75% of vital capacity
For FEF25-75 percentage predicted the relative change is analyzed. If screening FEV1 percentage predicted is missing, it will be imputed by the baseline value."|Baseline, Day 29, Day 57|Intent-to-treat (ITT) population: All randomized patients who received at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.||percentage change||Standard Error|Least Squares Mean
795855|NCT00918957|Secondary|Change From Baseline of ﻿Forced Vital Capacity (FVC) Percent Predicted to End of Dosing (Day 29) and to the End of Off-cycle Period (Day 57)|"Results of statistical analysis were calculated from an ANOVA model. Baseline is defined as the latest measurement prior to the first dosing of study medication.
Response (percentage change) = treatment + Screening FEV1 percentage predicted (<50 and >=50) + age (<13 and >=13) + error"|Baseline, Day 29, Day 57|Intent-to-treat (ITT) population: All randomized patients who received at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.||percentage change||Standard Error|Mean
795856|NCT00918957|Primary|Relative Change From Baseline of Forced Expiratory Volume in One Second (FEV1) Percent Predicted to End of Dosing (Day 29)|"Relative change in percentage predicted FEV1 in the Intent-to-treat (ITT), modified ITT (mITT) and Observed cases in the ITT populations were calculated from an adjusted analysis ANOVA model.
ITT Patients with missing or unacceptable Day 29 spirometry measurements had their primary endpoint data imputed with zero.
BSL = Baseline, defined as the latest measurement prior to the first dosing of study medication
- Relative change = 100 * (value - baseline) / baseline There were 3 patients who had no screening nor baseline values (due to inadequate spirometry) and so were excluded from all change from baseline analyses."|Baseline, Day 29|ITT: All randomized patients (pts) received at least one dose of study drug. Missing or unacceptable Day 29 spirometry test -change from baseline FEV1 % predicted imputed using last available post-baseline value or 0. mITT: Pts with unacceptable FEV1 measurements excluded. Observed cases: Pts with missing or unacceptable FEV1 measurements excluded.||change in percentage||Standard Error|Least Squares Mean
795857|NCT00919035|Secondary|Does the Prostate Specific Antigen (PSA) Doubling Times Change Before and After Treatment|PSA Doubling time is defined as the length of time that it takes for an individual patients PSA to double. PSA doubling times were calculated using the medial records at study entry for each patient. While the patient was on study their PSA doubling times were also calculated.|evaluate PSA doubling time pre study to actual doubling time while on study - calculated from start of study up to 10 cycles or 40 weeks.|PSA doubling time pre study was compared to PSA doubling time while the patients are on study, per protocol.||percentage of participants|||Number
795858|NCT00919035|Secondary|Time to Disease Progression|Time to disease progression is defined as the length of time from when the patient starts the study till disease progression. Disease progression is defined as more than 20% increase in the sum of longest diameter of measurable lesions compared to baseline, and/or evidence of new lesions on imaging studies. Or the appearance of 2 or more new bony lesions on a bone scan. Or newly developed cord compression or pathologic fracture.|Disease progression is assessed every 2 months, for up to 40 weeks, measured from day one of protocol treatment until the date the patient is off study.|||months||Full Range|Mean
795859|NCT00919035|Primary|Overall Clinical Benefit From Torisel® in Chemotherapy-naïve Castration Resistant Prostate Cancer (CRPC).|The overall clinical benefit is defined as the sum of complete response (CR), partial response (PR), and stable disease (SD). CR: is the disappearance of all measurable lesions including bone lesions detected on the bone scan, no evidence of new lesions, and no disease-related symptoms. PR: More than 30% decrease in the sum of longest diameter of measurable lesions compared to baseline. SD: Lesions should have no sufficient decrease for PR or CR and no sufficient increase to meet criteria for Progressive Disease (PD). PD: > 20% increase in the sum of longest diameter of measurable lesions compared to baseline, and/or evidence of new lesions on imaging studies OR The appearance of 2 or more new bony lesions on a bone scan is satisfactory for PD. Newly developed cord compression or pathologic fracture is defined as PD.|disease progression is assessed every 2 cycles, for up to 40weeks, per protocol, from the date of the first dose of study drug to the date the patient is taken off study|||percentage of participants|||Number
795860|NCT00919061|Primary|Median PFS|Progression free survival will be calculated from study entry to documented disease progression, death from any cause, or drop out due to toxicity, whichever occurs first.|6 mos|||months||95% Confidence Interval|Median
795861|NCT00919061|Primary|Progression-Free Survival|Progression free survival will be calculated from study entry to documented disease progression, death from any cause, or drop out due to toxicity, whichever occurs first.|6 months|||percentage of participants||95% Confidence Interval|Number
795862|NCT00919113|Secondary|Interstitial Cystitis Symptom Index (ICSI) Responders at Week 11.|Subjects that exhibited at least a 30% improvement from baseline in their total ICSI score, LOCF|at week 11|Efficacy analysis performed according to randomized treatment.||participants|||Number
795863|NCT00919113|Primary|Global Response Assessment (GRA) Responders at Week 11.|"subjects that indicated markedly improved or moderately improved on the GRA, LOCF"|at week 11|Efficacy analysis performed according to randomized treatment.||participants|||Number
795864|NCT00919126|Secondary|Serum Chemistry - Urea (mmol/L)|Urea (mmol/L) obtained from blood samples collected at baseline and in Morning following surgery|1 Postoperative Day|The analysis was done in the ITT Data Set (Randomised Patients).||mmol/L||Standard Deviation|Mean
795865|NCT00919126|Secondary|Serum Chemistry - Creatinine (Mcmol/L)|Creatinine (mcmol/L) obtained from blood samples collected at baseline and in Morning following surgery|1 Postoperative Day|The analysis was done in the ITT Data Set (Randomised Patients).||mcmol/L||Standard Deviation|Mean
795866|NCT00919126|Secondary|Serum Chemistry - Gamma GT (IU/L)|Gamma GT (IU/L) obtained from blood samples collected at baseline and in Morning following surgery|1 Postoperative Day|The analysis was done in the ITT Data Set (Randomised Patients)||IU/L||Standard Deviation|Mean
795867|NCT00919126|Secondary|Serum Chemistry - ALT (GPT) (IU/L)|ALT (GPT) (IU/L) obtained from blood samples collected at baseline and in Morning following surgery|1 Postoperative Day|The analysis was done in the ITT Data Set (Randomised Patients).||IU/L||Standard Deviation|Mean
796275|NCT00928408|Primary|Cinacalcet Dose|Cinacalcet dose at Month 12|Month 12|Full Analysis Set - Participants with Observed Data||mg/day||95% Confidence Interval|Mean
795871|NCT00919126|Secondary|Haematology - Leucocytes (Giga/L)|Leucocytes (Giga/L) obtained from blood samples collected at baseline and in the morning following surgery.|1 Postoperative Day|The analysis was done in the ITT Data Set (Randomised Patients).||Giga/L||Standard Deviation|Mean
795872|NCT00919126|Secondary|Stay in the Recovery Room|Time interval between admission in the recovery room and discharge from the recovery room.|1 Postoperative Day|The analysis was done in the ITT Data Set (Randomised Patients).||minutes||Standard Deviation|Mean
795873|NCT00919126|Secondary|Stay in the Operating Room|Time interval between admission in the operating room and discharge from the operating room.|1 Postoperative Day|The analysis was done in the ITT Data Set (Randomised Patients).||minutes||Standard Deviation|Mean
795874|NCT00919126|Secondary|Awakening Time|Time interval between the end of maintenance period and time of Aldrete score ≥ 9.|1 Postoperative Day|The analysis was done in the ITT Data Set (Randomised Patients).||minutes||Standard Deviation|Mean
795875|NCT00919126|Secondary|Anaesthesia Recovery Time|Time interval between the end of maintenance period and time of tracheal tube removal.|1 Postoperative Day|The analysis was done in the ITT Data Set (Randomised Patients).||minutes||Standard Deviation|Mean
795876|NCT00919126|Primary|Dose of Propofol (mg) Administered During Maintenance Adjusted to Patient Body Surface Area (BSA in m²) and Maintenance Duration (Min)|Dose of propofol administered with a Target Controlled Infusion (TCI) device, cerebral concentration equal to 5 µg/mL at the end of induction, and then concentration adjusted to the level of depth of anaesthesia during maintenance. Depth of anaesthesia continuously assessed by signals derived from electroencephalographic recording. Analgesia during induction and maintenance obtained with remifentanil administered with a second TCI device at the stable cerebral concentration of 7 ng/mL.|Maintenance period (1 Day)|The main analysis was done in the ITT Data Set (Randomised Patients).||mg adjusted||Standard Deviation|Mean
795877|NCT00919191|Secondary|Self Assessment of Burning/Stinging and Itching|Cumulative scores of Subjects' self assessment of burning/stinging and itching on a score from 0=none to 3=severe|Daily, for 3 weeks|||Scores on a Scale||Standard Deviation|Mean
795878|NCT00919191|Primary|Comparative Assessment of Facial Irritation and Cutaneous Effects.|Expert Grader Assessment, including cumulative scores for Erythema and Dryness on a scale of 0=none to 8=severe|Daily, for 3 weeks|All participants used both gels concurrently, on opposite sides of the face (split-face model)||Scores on a Scale||Standard Deviation|Mean
795879|NCT00919633|Secondary|Viral Decay||12 weeks of treatment||||||
795880|NCT00919633|Secondary|Functional Health, Depression Score, and Fatigue Level||through Study Week 72||||||
795881|NCT00919633|Secondary|Pharmacodynamics||through Study Week 72||||||
795882|NCT00919633|Secondary|Pharmacokinetics||through Study Week 72||||||
795883|NCT00919633|Secondary|End-of-treatment Response (EOT)||Study week 48||||||
795884|NCT00919633|Secondary|Early Virologic Response (EVR)||Study week 12|||participants|||Number
795885|NCT00919633|Secondary|Rapid Virologic Response (RVR)||Study Week 4|||participants|||Number
795886|NCT00919633|Primary|Safety/Tolerability||Through study week 72||||||
795887|NCT00919633|Primary|Viral Load: Incidence of Sustained Virologic Response (SVR)||24 weeks after treatment is complete|||participants|||Number
795888|NCT00919711|Secondary|Lumbar Spine BMD Percent Change From Baseline at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry|Baseline to month 12|All randomized subjects excluding those with missing post baseline data and missing covariate for regression imputation||Percent Change From Baseline||95% Confidence Interval|Mean
795889|NCT00919711|Secondary|Femoral Neck BMD Percent Change From Baseline at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry|Baseline to month 12|All randomized subjects excluding those with missing post baseline data and missing covariate for regression imputation||Percent Change From Baseline||95% Confidence Interval|Mean
795890|NCT00919711|Secondary|Serum CTX Percent Change From Baseline at Month 1|Serum Type-1 Collagen C-Telopeptide Percent Change From Baseline at Month 1|Baseline to month 1|All randomized subjects who enrolled in the bone marker substudy with observed data||Percent Change From Baseline||Inter-Quartile Range|Median
795891|NCT00919711|Primary|Total Hip BMD Percent Change From Baseline at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry|Baseline to month 12|All randomized subjects excluding those with missing post baseline data and missing covariate for regression imputation||Percent Change From Baseline||95% Confidence Interval|Mean
795892|NCT00919724|Primary|Endothelial Function (Brachial Artery Reactivity)|The maximum change in brachial artery diameter after induction of reactive hyperemia post-release of vascular occlusion. This is a measure of the ability of the endothelium to respond appropriately to lack of tissue oxygenation distal to the point of brachial artery compression.|Single measurement|||percent dilation||Standard Deviation|Mean
795893|NCT00919763|Secondary|Percent Change in TSS||from Baseline to Week 4||||||
795894|NCT00919763|Primary|Total Sum Score (TSS)of Target Lesion|"Total Sum Score (TSS) on the Target Lesion at Week 4 or Early Termination adjusted on Baseline (Sum of Erythema, Excoriation, Papulation/Induration, Oozing/Crusting and Lichenification of Target Lesion).
Scale values range from 0 - 3; 0 is minumal (best) and 3 is maximum (worst). Unit is used as score on a scale. Total possible minimum score is 0. Total possible maximum score is 15."|at Week 4|intention to treat (ITT) Last Observation Carried Forward (LOCF)||Scores on a scale||Standard Error|Least Squares Mean
795895|NCT00919802|Secondary|Secondary Outcome Measures Will Include Change From Baseline in Verbal Reports of Anxiety 6 Hours After Drug/Placebo Administration|A verbal anxiety report (VAR; 0-10 with 0 being no anxiety and 10 being the worst possible anxiety); a change from baseline measure was calculated for value measured 6 hours post drug/placebo administration|6 hours post drug or placebo administration|||units on a scale||Standard Error|Mean
795896|NCT00919802|Primary|Change From Baseline Measured as Global Response Assessment (GRA) Score at 6 and 24 Hours|This is a seven-point symmetric scale previously validated for use in IC studies in which patients are asked relative to baseline (over the last 6 hours for purposes of this study), -3 -are you markedly worse, -2 -moderately worse, -1 -slightly worse, 0-no change, +1-slightly improved, +2-moderately improved, or +3-markedly improved. A +2 or +3 can be defined categorically as a positive treatment response|6 and 24 hours post drug or placebo administration - the data below reflects 6 hour data|||units on a scale||Standard Error|Mean
796276|NCT00928408|Primary|Cinacalcet Dose|Cinacalcet dose at Month 6|Month 6|Full Analysis Set - Participants with Observed Data||mg/day||95% Confidence Interval|Mean
795897|NCT00919854|Secondary|Mean Change From Baseline to Week 24 and Week 48 in CD4+ Percentage||Baseline, Week 24 and Week 48|27 participants were recruited and received at least 1 dose of study medication; as Good Clinical Practice (GCP) requirements were not consistently adhered to at one site (involving 6 participant), analyses were performed excluding the participants from this site, resulting in 21 participants used for analyses.||Percentage of lymphocytes||Standard Error|Mean
795898|NCT00919854|Secondary|Mean Change From Baseline to Week 24 and Week 48 in Plasma log10 Viral Load||Baseline, Week 24 and Week 48|27 participants were recruited and received at least 1 dose of study medication; as Good Clinical Practice (GCP) requirements were not consistently adhered to at one site (involving 6 participant), analyses were performed excluding the participants from this site, resulting in 21 participants used for analyses.||log10 copies/mL||Standard Error|Mean
795899|NCT00919854|Secondary|Number of Participants With Less Than or Equal to 1 log10 Decrease in Plasma Viral Load at Week 24 and Week 48||Week 24 and Week 48|27 participants were recruited and received at least 1 dose of study medication; as Good Clinical Practice (GCP) requirements were not consistently adhered to at one site (involving 6 participant), analyses were performed excluding the participants from this site, resulting in 21 participants used for analyses.||Participants|||Number
795900|NCT00919854|Secondary|Number of Participants With Virological Response (Viral Load Less Than 400 Copies/mL) at Week 24 and Week 48||Week 24 and Week 48|27 participants were recruited and received at least 1 dose of study medication; as Good Clinical Practice (GCP) requirements were not consistently adhered to at one site (involving 6 participant), analyses were performed excluding the participants from this site, resulting in 21 participants used for analyses.||Participants|||Number
795901|NCT00919854|Secondary|Number of Participants With Virological Response (Viral Load Less Than 50 Copies/mL) at Week 48||Week 48|27 participants were recruited and received at least 1 dose of study medication; as Good Clinical Practice (GCP) requirements were not consistently adhered to at one site (involving 6 participant), analyses were performed excluding the participants from this site, resulting in 21 participants used for analyses.||Participants|||Number
795902|NCT00919854|Primary|Number of Participants With Virological Response (Viral Load Less Than 50 Copies/mL) at Week 24 - Time to Loss of Virologic Response (TLOVR)|The TLOVR algorithm was used to derive response, ie, response and loss of response needed to be confirmed at 2 consecutive visits and participants who permanently discontinued were considered nonresponders after discontinuation. Participants with intermittent missing viral load values were considered responders if the preceeding and succeeding visits indicated response. In all other cases, intermittent values were imputed with nonresponse. Resuppression after confirmed virologic failure was considered as failure in this algorithm.|Week 24|27 participants were recruited and received at least 1 dose of study medication; as Good Clinical Practice (GCP) requirements were not consistently adhered to at one site (involving 6 participant), analyses were performed excluding the participants from this site, resulting in 21 participants used for analyses.||Participants|||Number
795903|NCT00919867|Primary|T 1/2 of d-Amphetamine||0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose|PKP||hours||Standard Deviation|Mean
795904|NCT00919867|Primary|Tmax of d-Amphetamine||0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose|PKP||hours||Standard Deviation|Mean
795905|NCT00919867|Primary|AUC of d-Amphetamine||0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose|PKP||ng*h/ml||Standard Deviation|Mean
795906|NCT00919867|Primary|Cmax of d-Amphetamine||0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose|PKP||ng/ml||Standard Deviation|Mean
795907|NCT00919867|Primary|Time of Plasma Half-Life(T 1/2) of Guanfacine||0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose|PKP||hours||Standard Deviation|Mean
795908|NCT00919867|Primary|Time of Maximum Plasma Concentration (Tmax) of Guanfacine||0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose|PKP||hours||Standard Deviation|Mean
795909|NCT00919867|Primary|Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Guanfacine||0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose|PKP||ng*h/ml||Standard Deviation|Mean
795910|NCT00919867|Primary|Maximum Plasma Concentration (Cmax) of Guanfacine||0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose|Pharmacokinetic Population (PKP) consists of all subjects in the Safety Population who had evaluable concentration-time profiles for guanfacine or d-amphetamine. The Safety Population consists of all subjects who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.||ng/ml||Standard Deviation|Mean
795911|NCT00919893|Primary|Symptomatic Improvement in the Pain Domain of National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI)|Decrease in NIH-CPSI pain score. Best value: 0. Worst value: 21.|0, 6, 12 weeks|ITT (Intention to treat) LOCF (Last observation carried forward)||participants|||Number
795912|NCT00919893|Secondary|Secondary Outcomes Were Symptomatic Improvement of the NIH-CPSI Total Score, the Micturition and Life Quality Domains of the NIH-CPSI Questionnaire, Decrease in the Number of Leukocytes in Urine.|Decrease of score points. Decrease of leucocytes in urine.|0, 6, 12 weeks|||participants|||Number
795913|NCT00919932|Secondary|Exit Interview|Verbal interview|1 month|||participants|||Number
795914|NCT00919932|Primary|Therapy Homework Compliance: Percent Homework Completed|Number of thought logs completed over the course of the 4 week trial.|1 month|||homework sheets completed||Standard Deviation|Mean
795915|NCT00920023|Primary|To Determine the Specificity of High Resolution Magnetic Resonance Imaging With Lymphotrophic Superparamagnetic Nanoparticles to Identify Small and Otherwise Undetectable Lymph Node Metastases.|Using Pathology as the gold standard the excised nodes were correlated and the percentage of true negative nodes were measured on the post contrast exam. Specificity is the percentage of true negative cases as identified as negative.|3 years|||Percentage of true negative sample||95% Confidence Interval|Number
795916|NCT00920023|Primary|To Determine the Sensitivity High Resolution Magnetic Resonance Imaging With Lymphotrophic Superparamagnetic Nanoparticles to Identify Small and Otherwise Undetectable Lymph Node Metastases.|Using Pathology as the gold standard the excised nodes were correlated and the percentage of positive cases were measured on the post contrast exam. Sensitivity is the percentage of positive cases (i.e., metastases confirmed using pathology) identified as positive.|3 years|||percentage of positive cases||95% Confidence Interval|Number
796145|NCT00927849|Primary|Relieve of Anal Pain|using a visual analog scale (VAS) with which each patients noted the severity of pain at each evaluated time using a linear between zero (no pain) and 10 ( severe pain)|one year after the procedure|||score in scale||Standard Deviation|Mean
795917|NCT00920075|Secondary|Number of Participants With Fracture|Participants who earlier completed in our open labeled or double blind study of alendronate treatment for juvenile osteoporosis, were invited for one clinical visit. Their bone densities of spine and hip were measured by DXA scan. During this visit, their fracture history was obtained.|Post study (1-6 years), one clinical visit|11 participants responded to participate in the post study. During their one clinic visit, their fracture history during the period before coming to the post study was obtained.||particilants|||Number
795918|NCT00920075|Secondary|Bone Mineral Density (BMD) of the Hip (Participants With Percentage Increase).|Participants who earlier completed in our open labeled or double blind study of alendronate treatment for juvenile osteoporosis, were invited for one clinical visit. Bone density of hip was measured by DXA scan.|Post study (1-6 years), one clincial visit|11 participants responded to participate in the post study. Their bone density of Hip was measured by DXA scan. Increase in percentage density of Hip was obtained from that of previous values. One participant showed a slight decrease in bone density.||participants|||Number
795919|NCT00920075|Primary|Bone Mineral Density (BMD) of the Lumbar Spine (Participants With Percentage Increase).|Participants who earlier completed in our open labeled or double blind study of alendronate treatment for juvenile osteoporosis, were invited for one clinical visit. Bone density of spine was measured by DXA scan.|Post study (1-6 yrs), one clinical visit|Participants who earlier completed our phase I or phase II study on alendronate in juvenile osteoporosis, were invited to participate in the current post study evaluation of bone density and fractures.||participants|||Number
795920|NCT00920140|Secondary|Overall Survival by Cohort|Overall survival is defined as the time from the start of study treatment (GSK1120212) until death due to any cause. For the analysis of overall survival, the last date of known contact was used for those participants who had not died at the time of analysis; such participants were considered censored.|From the start of the study drug until the final study visit (up to approximately 407 days )|Efficacy Population. The number of participants for the Cohort 2: AML/MDS/CMML with RAS wt/Unknown treatment group is equal to the 8 participants from Phase 1 plus the 22 participants from Phase 2 (total of 30).||Months||90% Confidence Interval|Median
795921|NCT00920140|Secondary|Ctau of GSK1120212 in Part 2|Ctau is the pre-dose (trough) concentration at the end of the dosing interval and was measured for Cycle 1 Day 15 (C1D15), Cycle 2 Day 1(C2D1), Cylce 3 Day 1 (C3D1), Cycle 4 Day 1 (C4D1), Cycle 5 Day 1 (C5D1), Cycle 6 Day 1 (C6D1), Cycle 7 Day 1 (C7D1), Cycle 8 Day 1 (C8D1), Cycle 9 Day 1 (C9D1), Cycle 10 Day 1 (C10D1), Cycle 11 Day 1 (C11D1) and Cycle 12 Day 1 (C12D1). Blood samples for PK analysis were collected pre-dose (i.e., no later than 15 min prior to dosing).|C1D15, C2D1, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1, C9D1, C10D1, C11D1 and C12D1|Pharmacokinetic Population. Only participants with data available at the indicated time points were analyzed.||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
795922|NCT00920140|Secondary|Accumulation Ratio (AR) of GSK1120212 in Part 1|AR is the ratio of the Day 15 AUC0-tau (0 hour to last dose interval) and Day 1 AUC0-tau (AUCtau C1D15/AUCtau C1D1). Blood samples for PK analysis were taken on Day 1 and Day 15 (within 30 min before study drug administration) and at 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, and 24 h post-dose. All other PK sampling were done pre-dose (i.e., within 30 min before study drug administration).|Cycle 1 Day 1 and Cycle 1 Day 15|Pharmacokinetic Population. Only participants with data available at the indicated time points were analyzed.||Ratio||Geometric Coefficient of Variation|Geometric Mean
795923|NCT00920140|Secondary|Tmax of GSK1120212 in Part 1|Tmax is defined as the time to reach the observed maximum concentration and was measured for C1D1 and C1D15. Blood samples for PK analysis were taken on Day 1 and Day 15 (within 30 min before study drug administration) and at 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, and 24 h post-dose. All other PK sampling were done pre-dose (i.e., within 30 min before study drug administration).|Cycle 1 Day 1 and Cycle 1 Day 15|Pharmacokinetic Population. Only participants with data available at the indicated time points were analyzed.||Hours||Full Range|Median
795924|NCT00920140|Secondary|t1/2 at C1D1 and t1/2 Effective (Eff.) at C1D15 of GSK1120212 in Part 1|t1/2 is defined as terminal phase half-life, which is the time required for the amount of the drug in the body to decrease by half and was measured for C1D1. t1/2eff. is defined as the effective half-life and was measured for C1D15. Blood samples for PK analysis were taken on Day 1 and Day 15 (within 30 min before study drug administration) and at 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, and 24 h post-dose. All other PK sampling were done pre-dose (i.e., within 30 min before study drug administration).|Cycle 1 Day 1 (t1/2) and Cycle 1 Day 15 (t1/2eff)|Pharmacokinetic Population. Only participants with data available at the indicated time points were analyzed.||Hours||Geometric Coefficient of Variation|Geometric Mean
795925|NCT00920140|Secondary|Cmin and Cmax of GSK1120212 in Part 1|Cmax is defined as the maximum observed concentration of GSK1120212 and was measured for C1D1 and C1D15. Cmin is defined as the minimal observed concentration of GSK1120212 and was measured for C1D15. Blood samples for PK analysis were taken on Day 1 and Day 15 (within 30 min before study drug administration) and at 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, and 24 h post-dose. All other PK sampling were done pre-dose (i.e., within 30 min before study drug administration).|Cycle 1 Day 1 and Cycle 1 Day 15|Pharmacokinetic Population. Only participants with data available at the indicated time points were analyzed.||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
795926|NCT00920140|Secondary|AUC(0-24), AUC(0-t), and AUC(0-tau) of GSK1120212 in Part 1|Area under the concentration-time (AUC) curve from time zero (pre-dose) to 24 hours (AUC[0-24]) for Cycle 1 Day 1 (C1D1), from time zero to the last time of a quantifiable concentration (AUC[0-t]) for C1D1 and Cylce 1 Day 15 (C1D15) and AUC curve over the dosing interval AUC[0-tau] for C1D15 were measured. Blood samples for PK analysis were taken on Day 1 and Day 15 (within 30 minutes [min] before study drug administration) and at 0.5 hour (h), 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, and 24 h post-dose. All other PK sampling were done pre-dose (i.e., within 30 min before study drug administration).|Cycle 1 Day 1 and Cycle 1 Day 15|Pharmacokinetic Population: all participants included in the All Treated Population for whom a PK sample was obtained and analyzed. Only participants with data available at the indicated time points were analyzed.||nanograms*hour/milliliter||Geometric Coefficient of Variation|Geometric Mean
795952|NCT00926367|Secondary|Product Acceptability and Preference Questionnaire - Was the Study Product Easy to Use With Make-up?|"The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: Was the study product easy to use with make-up?
The subject replied using the following scale:
0 - Not Applicable
- Very Easy
- Easy
- Neutral
- Difficult
- Very Difficult"|Day 14|||units on a scale||Standard Deviation|Mean
795927|NCT00920140|Primary|Number of Participants With an Investigator-assessed Best Response (Achieving Complete Response [CR], Marrow CR, Partial Response [PR], Complete Response Without Platelet Recovery [CRp] or Morphologic Leukaemia-free State[MLFS]) by Cohort|Overall response rate (ORR=CR+CRp+Marrow CR+MLFS+PR) was calculated from the investigator’s assessment of response recorded within the first eight weeks of treatment. CR includes complete remission. Complete remission is a state in which the participant must be free of all symptoms related to leukemia and have an absolute neutrophil count >=1 x 10^9/L, platelet count >=100 x 10^9/L, and normal marrow differential (<=5% blasts). PR includes partial remission. Partial remission is a state in which the participant has a CR with 6 to 25% abnormal cells in the marrow or 50% decrease in bone marrow blasts. CRp is as per CR but platelet count <100 x 10^9/L. MLFS is a state in which the participant has a normal marrow differential (<5% blasts), neutrophil, and platelet counts are not considered.|From the start of the study drug until the final study visit (up to approximately 407 days)|Efficacy Population: all participants included in the All Treated Population who had received at least one dose of 2 mg of study drug in Phase 2. The number of participants for the Cohort 2: AML/MDS/CMML with RAS wt/Unknown treatment group is equal to the 8 participants from Phase 1 plus the 22 participants from Phase 2 (total of 30).||Participants|||Number
795928|NCT00920140|Primary|Number of Participants With a Change From Baseline in Temperature by Dose|Change from Baseline in temperature is categorized as a decrease to <=35 degrees celsius (C), change to normal or no change, and increase to >=38 degrees C. Participants with a missing Baseline value are assumed to have a normal Baseline value. Participants (par.) are counted twice if the participant temperature value decreased to <=35 degrees C and increased to >=38 degrees C post-Baseline. Only those participants with temperature values for worst-case on-therapy are presented.|From the start of the study drug until the final study visit (up to approximately 407 days)|All Treated Population (ATP). Only those par. available at the specified time points were analyzed. Different par. may have been analyzed for different parameters; the overall number analyzed reflects everyone in the ATP. One Phase 2 par. was incorrectly dosed (received <2 mg [0.5 mg]); thus, 6 par. receiving GSK1120212 <2 mg OD were analyzed.||Participants|||Number
795929|NCT00920140|Primary|Number of Participants With a Change From Baseline in Systolic and Diastolic Blood Pressure by Dose|Change from Baseline in systolic blood pressure (SBP) is categorized as: Grade 0 (<120 millimeters of mercury [mmHg]), Grade 1 (120-139 mmHg), Grade 2 (140-159 mmHg), and Grade 3/4 (>=160 mmHg). Change from Baseline in diastolic blood pressure (DBP) is categorized as: Grade 0 (<80 mmHg), Grade 1 (80-89 mmHg), Grade 2 (90-99 mmHg), and Grade 3/4 (>=100 mmHg). An increase is defined as an increase in the CTCAE grade relative to the Baseline grade. Participants with missing Baseline values are assumed to have a Baseline value of grade 0. Only those participants (par.) with blood pressure values for worst-case on-therapy are presented.|From the start of the study drug until the final study visit (up to approximately 407 days)|All Treated Population (ATP). Only those par. available at the specified time points were analyzed. Different par. may have been analyzed for different parameters; the overall number analyzed reflects everyone in the ATP. One Phase 2 par. was incorrectly dosed (received <2 mg [0.5 mg]); thus, 6 par. receiving GSK1120212 <2 mg OD were analyzed.||Participants|||Number
795930|NCT00920140|Primary|Number of Participants With a Change From Baseline in Heart Rate by Dose|Change from Baseline in heart rate is categorized as decrease to <60 beats per minute (bpm), change to normal or no change, and increase to >100 bpm. Participants with a missing Baseline value are assumed to have a normal Baseline value. Participants are counted twice if the participant heart rate value decreased to <60 bpm and increased to >100 bpm post-baseline. Only those participants (par.) with heart rate values for worst-case on-therapy are presented.|From the start of the study drug until the final study visit (up to approximately 407 days)|All Treated Population (ATP). Only those par. available at the specified time points were analyzed. Different par. may have been analyzed for different parameters; the overall number analyzed reflects everyone in the ATP. One Phase 2 par. was incorrectly dosed (received <2 mg [0.5 mg]); thus, 6 par. receiving GSK1120212 <2 mg OD were analyzed.||Participants|||Number
795931|NCT00920140|Primary|Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Clinical Chemistry Parameters by Dose|Hematology and clinical chemistry data were summarized according to NCI-CTCAE grade, version 3.0. Grade 1, Mild; Grade 2, Moderate; Grade 3, Severe; Grade 4, Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to Grade 3 or Grade 4 occurred. Clinical chemistry tests where the toxicity grade is defined by NCI-CTCAE includes albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase (AST), total bilirubin, calcium, creatinine, glucose, bicarbonate, potassium, magnesium, sodium, and phosphorus. Participants with missing Baseline grades were assumed to have a Baseline grade of 0. Only those participants (par.) with laboratory values for worst-case on-therapy are presented.|From the start of the study drug until the final study visit (up to approximately 407 days)|All Treated Population (ATP). Only those par. available at the specified time points were analyzed. Different par. may have been analyzed for different parameters; the overall number analyzed reflects everyone in the ATP. One Phase 2 par. was incorrectly dosed (received <2 mg [0.5 mg]); thus, 6 par. receiving GSK1120212 <2 mg OD were analyzed.||Participants|||Number
795932|NCT00920140|Primary|Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Hematology Parameters by Dose|Hematology and clinical chemistry data were summarized according to National Cancer Institutes (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade, version 3.0. Grade 1, Mild; Grade 2, Moderate; Grade 3, Severe; Grade 4, Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to Grade 3 or Grade 4 occurred. Hematology tests where the toxicity grade is defined by NCI-CTCAE includes hemoglobin, international normalized ratio (INR), lymphocytes, total neutrophils, platelet count, and partial thromboplastin time (PTT). Participants with missing baseline grades were assumed to have a baseline grade of 0. Only those participants (par.) with laboratory values for worst-case on-therapy (defined as the worst shift that occurred at any time during the treatment period) are presented.|From the start of the study drug until the final study visit (up to approximately 407 days)|All Treated Population (ATP). Only those par. available at the specified time points were analyzed. Different par. may have been analyzed for different parameters; the overall number analyzed reflects everyone in the ATP. One Phase 2 par. was incorrectly dosed (received <2 mg [0.5 mg]); thus, 6 par. receiving GSK1120212 <2 mg OD were analyzed.||Participants|||Number
796277|NCT00928408|Primary|Cinacalcet Dose|Cinacalcet dose at Month 3|Month 3|Full Analysis Set - Participants with Observed Data||mg/day||95% Confidence Interval|Mean
795933|NCT00920140|Primary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) by Dose|An AE is any untoward medical occurrence in a participant (par.) or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.|From the start of the study drug until the final study visit (up to approximately 407 days)|All Treated Population: all participants who received at least one dose of study medication. Safety data was evaluated based on this population. One Phase 2 par. was incorrectly dosed (received <2 mg [0.5 mg]); thus, 6 par. receiving GSK1120212 <2 mg OD were analyzed.||Participants|||Number
795934|NCT00920231|Secondary|Ability to Meet the Subjective Travel Needs of the Blind Subject|This is a subjective rating that incorporates user friendliness of the system and the specific needs of the subject. The subject is asked to rate whether the device meets his or her travel needs on a 1 to 7 scale with 1 being excellent and 7 being very poor.|no time limit|||units on a scale||Standard Error|Mean
795935|NCT00920231|Primary|Frequency of Device Failures Per Attempt to Complete a Navigation Course|device failures were defined as any failure to provide correct location and direction information at thre appropriate time, resulting in a mistake that needed the initial prototype's ability to meet their travel needs at a good to excellent range.|The subject is given as much time as needed to complete the task|||number of device failures per attempt||Standard Error|Mean
795936|NCT00920309|Secondary|Glomerular Filtration Rate (Kidney Function)||2 years|Outcome measures were not analyzed due to study termination|||||
795937|NCT00920309|Primary|Total Kidney Volume (mL)||2 years|Outcome Measures were not analyzed due to study termination|||||
795938|NCT00920374|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|An SAE is any untoward medical occurrence that: results in death, is lifethreatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|During the entire study period|||subjects|||Number
795939|NCT00920374|Primary|Seroprotection Power|Seroprotection power is defined as the number of subject who had a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:40|Day 21|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available data||subjects|||Number
795940|NCT00920374|Primary|Seroconversion Factor|Seroconversion factor, defined as the fold increase in serum HI GMT post-vaccination compared to pre-vaccination (Day 0), is presented for all three vaccine influenza virus strains|Day 21|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available data||fold increase||95% Confidence Interval|Mean
795941|NCT00920374|Primary|Number of Seroconverted Subjects|A seroconverted subject is a subject with a pre-vaccination serum HI titer < 1:10 and a post-vaccination serum HI titer ≥ 1:40, or a pre-vaccination serum HI titer ≥ 1:10 and a fold increase (Day 21/Day 0) ≥ 4|Day 21|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available data||subjects|||Number
795942|NCT00920374|Primary|Number of Seroprotected Subjects|A seroprotected subject is a subject with a serum HI antibody titer ≥ 1:40|Day 0 and Day 21|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available data||subjects|||Number
795943|NCT00920374|Primary|Number of Subjects With HI Antibody Titer Above the Cut-off Value|The cut-off value assessed was ≥ 1:10 and was presented for all three vaccine influenza virus strains|Day 0 and Day 21|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available data||subjects|||Number
795944|NCT00920374|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|During the 21-day (Day 0-20) post-vaccination period|||subjects|||Number
795945|NCT00920374|Secondary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, shivering, sweating, and fever|During the 4-day (Day 0-3) post-vaccination period|||subjects|||Number
795946|NCT00920374|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include ecchymosis, induration, pain, redness, and swelling.|During the 4-day (Day 0-3) post-vaccination period|||subjects|||Number
795947|NCT00920374|Primary|Hemagglutination Inhibition (HI) Antibody Titer|Titers given as geometric mean titer (GMT) were presented for all three vaccine influenza virus strains|Day 0 and Day 21|Analysis was performed on the According-To-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data||titer||95% Confidence Interval|Geometric Mean
795948|NCT00926328|Primary|Plaque Index|Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|6 Months|Per protocol||Units on a scale||Standard Deviation|Mean
795949|NCT00926328|Primary|Gingivitis Index|"Units on a scale 0 to 3 (0 = no inflammation ,
1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing.
3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)"|6 months|||Units on a scale||Standard Deviation|Mean
795950|NCT00926367|Secondary|Product Acceptability and Preference Questionnaire - How do You Rate the Ease of Application of the Study Product?|"The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: Was the study product easy to use with make-up?
The subject replied using the following scale:
0 - Not Applicable
- Very Easy
- Easy
- Neutral
- Difficult
- Very Difficult"|Day 14|||units on a scale||Standard Deviation|Mean
795951|NCT00926367|Secondary|Product Acceptability and Preference Questionnaire - What Was Your Overall Satisfaction of the Study Product?|"The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: What was your overall satisfaction of the study product?
The subject replied using the following scale:
- Very Satisfied
- Satisfied
- Neutral
- Unsatisfied
- Very Unsatisfied"|Day 14|||units on a scale||Standard Deviation|Mean
795953|NCT00926367|Secondary|Product Acceptability and Preference Questionnaire - Did You Feel That Your Skin Was Hydrated and Moisturized While You Were on Your Study Product?|"The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: Did you feel that your skin was hydrated and moisturized while you were on your study product?
The subject replied using the following scale:
1 - Yes 0 - No"|Day 14|||units on a scale||Standard Deviation|Mean
795954|NCT00926367|Secondary|Product Acceptability and Preference Questionnaire - How Compliant Were You With Applying the Study Product Each and Every Day?|"The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: How compliant were you with applying the study product each and every day?
The subject replied using the following scale:
0 - Not Compliant at all (<50%)
- Mostly Compliant (50%-79%)
- Very Compliant (80%-100%)"|Day 14|||units on a scale||Standard Deviation|Mean
795955|NCT00926367|Secondary|Product Acceptability and Preference Questionnaire - How do You Rate the Comfort of the Skin Where You Are Currently Treating With the Study Product?|"The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: How do you rate the comfort of the skin where you are currently treating with the study product?
The subject replied using the following scale:
- Very Comfortable
- Comfortable
- Somewhat Comfortable
- Somewhat Uncomfortable
- Uncomfortable"|Day 14|||units on a scale||Standard Deviation|Mean
795956|NCT00926367|Secondary|Self Assessment of Oiliness|"The amount of oiliness on the left and right cheek of each panelist.
The scale used to evaluate oiliness is:
Scale Description:
(scale: 0 = none to 3 = severe)
Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14."|Baseline, Day 1 through Day 14|||units on a scale||Standard Deviation|Mean
795957|NCT00926367|Secondary|Self Assessment of Blistering|"The amount of blistering on the left and right cheek of each panelist.
The scale used to evaluate blistering is:
Scale Description:
(scale: 0 = none to 3 = severe)
Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14."|Baseline, Day 1 through Day 14|||units on a scale||Standard Deviation|Mean
795958|NCT00926367|Secondary|Self Assessment of Crusting|"The amount of crusting on the left and right cheek of each panelist.
The scale used to evaluate crusting is:
Scale Description:
(scale: 0 = none to 3 = severe)
Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14."|Baseline, Day 1 through Day 14|||units on a scale||Standard Deviation|Mean
795959|NCT00926367|Secondary|Self Assessment of Pain|"The amount of pain on the left and right cheek of each panelist.
The scale used to evaluate pain is:
Scale Description:
(scale: 0 = none to 3 = severe)
Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14."|Baseline, Day 1 through Day 14|||units on a scale||Standard Deviation|Mean
795960|NCT00926367|Secondary|Self Assessment of Texture (Roughness)|"The amount of roughness on the left and right cheek of each panelist.
The scale used to evaluate roughness is:
Scale Description:
(scale: 0 = none to 3 = severe)
Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14."|Baseline, Day 1 through Day 14|||units on a scale||Standard Deviation|Mean
795961|NCT00926367|Secondary|Self Assessment of Dryness|"The amount of dryness on the left and right cheek of each panelist.
The scale used to evaluate dryness is:
Scale Description:
(scale: 0 = none to 3 = severe)
Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14."|Baseline, Day 1 through Day 14|||units on a scale||Standard Deviation|Mean
795962|NCT00926367|Secondary|Self Assessment of Stinging|"The amount of stinging on the left and right cheek of each panelist.
The scale used to evaluate stinging is:
Scale Description:
(scale: 0 = none to 3 = severe)
Subject Self Assessments of stinging were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14."|Baseline, Day 1 through Day 14|||units on a scale||Standard Deviation|Mean
795963|NCT00926367|Secondary|Self Assessment of Burning|"The amount of burning on the left and right cheek of each panelist.
The scale used to evaluate burning is:
Scale Description:
(scale: 0 = none to 3 = severe)
Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14."|Baseline, Day 1 through Day 14|||units on a scale||Standard Deviation|Mean
795964|NCT00926367|Secondary|Skin Hydration|"The ability of an alternating current to flow through the stratum corneum is an indirect measure of its water content. The value recorded is expressed in microsiemens. Higher values indicate greater levels of skin hydration.
Test results were compared to measurements from the other side of the face, which was not treated instead of referring to a normal range. A normal range does not exist for this measurement. Instead, the non-treated side of the face was used as a control to determine the normal level of skin hydration."|Baseline, 4 hrs. post 1st Treatment, Days 3, 7, and 14|||Microsiemens||Standard Deviation|Mean
795965|NCT00926367|Primary|Skin Dryness|"The amount of dryness on the left and right cheek of each panelist.
The scale used to evaluate skin dryness is:
Grade Description 0 None 2 Slight flaking 4 Moderate flaking/scaling 6 Marked scaling / slight fissuring 8 Severe scaling, fissuring
Expert Grader assessments of dryness were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14."|Baseline, Day 1 through Day 14|||units on a scale||Standard Deviation|Mean
795966|NCT00926367|Secondary|Skin Moisture and Hydration|"To assess skin moisture and hydration using transepidermal water loss (TEWL). Results are measured on a continuous scale. Higher values indicate greater water loss/ lower skin moisture levels.
Evaporative water loss measurements provide an instrumental assessment of skin barrier function(one of the layers of the skin. Damage leads to a disruption of the barrier that is accompanied by elevated water loss rates and affects skin moisture and hydration. Higher values indicate greater water loss."|Baseline, Days 3, 7, and 14|||TEWL rates (gm/m2/hr)||Standard Deviation|Mean
795967|NCT00926367|Primary|Skin Erythema (Redness)|"Assessment of erythema as part of an evaluation of tolerance of two treatments: clindamycin and benzoyl peroxide or dapsone gel. This was done by visual assessment by an independent blinded grader using the grading scale shown below.
Grade Description 0 None 2 Mild erythema 4 Moderate confluent erythema 6 Marked erythema with some edema 8 Marked erythema, edema, possible erosion"|Baseline, Day 1 through Day 14|||Units on a scale||Standard Deviation|Mean
795968|NCT00926393|Secondary|Number of Patients With Potential Somnolence|Number of patients with adverse events potentially associated with somnolence collected by MedDRA Preferred Terms as lethargy, sedation, somnolence|From start of the study treatment to last dose plus 30 days|||Patients|||Number
795969|NCT00926393|Secondary|Number of Patients With Potential Extrapyramidal Symptoms (EPS)|Number of patients with adverse events potentially associated with EPS collected by MedDRA Preferred Terms as akathisia, extrapyramidal disorder, restlessness|From start of the study treatment to last dose plus 30 days|The randomized safety analysis data set included all patients who received at 1 dose of randomized study treatment during the Randomized treatment Phase, classified according to actual treatment taken.||Patients|||Number
795970|NCT00926393|Secondary|Change in Abnormal Involuntary Movement Scale (AIMS) Total Score|AIMS total score is the sum of the 10 individual-item scores (range:0-40), with the score for each item ranging from 0 to 4. Change : total score at day 7 minus total score at randomization. Increase in Change of total score indicates an increase in abnormal voluntary movements.|Randomization to Day 7|The randomized safety analysis data set included all patients who received at 1 dose of randomized study treatment during the Randomized treatment Phase, classified according to actual treatment taken.||units on scale||Standard Deviation|Mean
795971|NCT00926393|Secondary|Change in Barnes Akathisia Rating Scale (BARS) Global Score|BARS global score is the 4th individual-item score on the BARS scale,the Global Assessment of Akathisia, with the score ranging from 0 to 5. Change : score at day 7 minus score at randomization. Increase in Change of BARS global score indicates an increase in akathisia.|Randomization to Day 7|The randomized safety analysis data set included all patients who received at 1 dose of randomized study treatment during the Randomized treatment Phase, classified according to actual treatment taken.||units on scale||Standard Deviation|Mean
795972|NCT00926393|Secondary|Change in Simpson-Angus Scale (SAS) Total Score|SAS total score is the sum of the 10 individual-item scores (range:0-40), with the score for each item ranging from 0 to 4, higher scores indicate greater severity of Parkinsonian symptoms. Change : total score at day 7 minus total score at randomization. Increase in Change of total score indicates an increase in extrapyramidal motor symptoms.|Randomization to Day 7|The randomized safety analysis data set included all patients who received at 1 dose of randomized study treatment during the Randomized treatment Phase, classified according to actual treatment taken.||units on scale||Standard Deviation|Mean
795973|NCT00926393|Secondary|Area Under the Modified Bond-Lader Visual Analog Scale-time Curve|Area under the Modified Bond-Lader VAS-time curve is calculated by the linear trapezoidal formula which equals sum of (Ck+Ck+1)/2 multiplied by the time interval between k and k+1 observations, where Ck and Ck+1 are the corresponding the intensity of sedation evaluations measured by the Modified Bond-Lader VAS from 1 to 14 hours post-dose|During Day 2 (50 mg)|The randomized safety analysis data set included all patients who received at 1 dose of randomized study treatment during the Randomized treatment Phase, classified according to actual treatment taken.||mm * hour||Standard Error|Least Squares Mean
795974|NCT00926393|Secondary|Time to Maximum Intensity Modified Bond-Lader Visual Analog Scale Score|Time (Tmax) to Maximum Intensity Modified Bond-Lader VAS after dose is corresponding assessment time (one from 1, 2, 3, 4, 5, 12, 13, 14 hours post-dose) of MaxIntVas|During Day 2 (50 mg)|The modified intent-to-treat (MITT) analysis data set included all randomized patients who received study treatment, classified according to their randomized treatment and provided the Modified Bond-Lader VAS score at baseline (pre-dose at Day 1 or Day 2) and at least 1 hour after 50 mg dose administration.||Hours||Standard Error|Least Squares Mean
795975|NCT00926393|Secondary|Maximum Intensity Modified Bond-Lader Visual Analog Scale Score|The Maximum Intensity Modified Bond-Lader VAS after dose (MaxIntVAS) is calculated as maximum possible value of VAS during that day at any from 1, 2, 3, 4, 5, 12, 13, 14 hours post-dose assessments|During Day 2 (50 mg)|The modified intent-to-treat (MITT) analysis data set included all randomized patients who received study treatment, classified according to their randomized treatment and provided the Modified Bond-Lader VAS score at baseline (pre-dose at Day 1 or Day 2) and at least 1 hour after 50 mg dose administration.||units on scale||Standard Error|Least Squares Mean
795976|NCT00926393|Secondary|Modified Bond-Lader Visual Analog Scale Score After 300-mg Dose (Day 6)|The Modified Bond-Lader Visual Analog Scale (VAS) uses a 100 mm line, each with a set of opposing adjectives at either end:Alert (=0) – Drowsy (=100); If patient is sleeping the Bond-Lader VAS will be assign a score of 100.|At 1 hour post-dose, Day 6 (300 mg)|The modified intent-to-treat (MITT) analysis data set included all randomized patients who received study treatment, classified according to their randomized treatment and provided the Modified Bond-Lader VAS score at baseline (pre-dose at Day 1 or Day 2) and at least 1 hour after 50 mg dose administration.||units on scale||Standard Error|Least Squares Mean
795977|NCT00926393|Secondary|Modified Bond-Lader Visual Analog Scale Score After 300-mg Dose (Day 5)|The Modified Bond-Lader Visual Analog Scale (VAS) uses a 100 mm line, each with a set of opposing adjectives at either end:Alert (=0) – Drowsy (=100); If patient is sleeping the Bond-Lader VAS will be assign a score of 100.|At 1 hour post-dose, Day 5 (300 mg)|The modified intent-to-treat (MITT) analysis data set included all randomized patients who received study treatment, classified according to their randomized treatment and provided the Modified Bond-Lader VAS score at baseline (pre-dose at Day 1 or Day 2) and at least 1 hour after 50 mg dose administration.||units on scale||Standard Error|Least Squares Mean
795978|NCT00926393|Secondary|Modified Bond-Lader Visual Analog Scale Score After 200-mg Dose (Day 4)|The Modified Bond-Lader Visual Analog Scale (VAS) uses a 100 mm line, each with a set of opposing adjectives at either end:Alert (=0) – Drowsy (=100); If patient is sleeping the Bond-Lader VAS will be assign a score of 100.|At 1 hour post-dose, Day 4 (200 mg)|The modified intent-to-treat (MITT) analysis data set included all randomized patients who received study treatment, classified according to their randomized treatment and provided the Modified Bond-Lader VAS score at baseline (pre-dose at Day 1 or Day 2) and at least 1 hour after 50 mg dose administration.||units on scale||Standard Error|Least Squares Mean
795979|NCT00926393|Secondary|Modified Bond-Lader Visual Analog Scale Score After 100-mg Dose (Day 3)|The Modified Bond-Lader Visual Analog Scale (VAS) uses a 100 mm line, each with a set of opposing adjectives at either end:Alert (=0) – Drowsy (=100); If patient is sleeping the Bond-Lader VAS will be assign a score of 100.|At 1 hour post-dose, Day 3 (100 mg)|The modified intent-to-treat (MITT) analysis data set included all randomized patients who received study treatment, classified according to their randomized treatment and provided the Modified Bond-Lader VAS score at baseline (pre-dose at Day 1 or Day 2) and at least 1 hour after 50 mg dose administration.||units on scale||Standard Error|Least Squares Mean
796146|NCT00927849|Primary|Effect of Closed Lateral Sphincterotomy and Chemical Sphincterotomy on Hypertensive Anal Canal|effect of closed lateral sphincterotomy and chemical sphincterotomy on hypertensive anal canal, anal manometery|one year||||||
795980|NCT00926393|Primary|Modified Bond-Lader Visual Analog Scale Score After 50-mg Dose (Day 2)|The Modified Bond-Lader Visual Analog Scale (VAS) uses a 100 mm line, each with a set of opposing adjectives at either end:Alert (=0) – Drowsy (=100); If patient is sleeping the Bond-Lader VAS will be assign a score of 100.|At 1 hour post-dose, Day 2 (50 mg)|The modified intent-to-treat (MITT) analysis data set included all randomized patients who received study treatment, classified according to their randomized treatment and provided the Modified Bond-Lader VAS score at baseline (pre-dose at Day 1 or Day 2) and at least 1 hour after 50 mg dose administration.||units on scale||95% Confidence Interval|Least Squares Mean
795981|NCT00926497|Primary|Absolute Duration of Antibiotic Therapy|Co-primary endpoint was the absolute duration of antibiotic therapy(quantitative version of the primary endpoint for estimation of effect size)|1 month|||hours||Full Range|Mean
795982|NCT00926497|Primary|Antibiotic Treatment for More Than 72 Hours|Infants treated with antibiotics for more than 72 hours (efficacy of study intervention)|1 month|||participants|||Number
795983|NCT00926536|Primary|Cumulative Dose (CD), a Measure of Radiation Dose|CD - a measurement of total radiation to the skin (measure of a deterministic dose)|Duration of a TACE procedure, an average of 2 hours|CD measured in both groups||mGy||Full Range|Mean
795984|NCT00926536|Primary|Dose Area Product (DAP)|Dose area product (DAP) is a measure of the entire amount of energy (radiation dose) delivered to the patient by the beam (indicator of stochastic dose)|Duration of a TACE procedure, an average of 2 hours|DAP measured in both groups||Gy.cm2||Full Range|Mean
795985|NCT00926575|Secondary|Survival Status||Day 200||||||
795986|NCT00926575|Secondary|Cumulative Exposure to Prednisone||Day 80||||||
795987|NCT00926575|Primary|The Proportion of Subjects With GVHD Treatment Failure|The primary endpoint is the occurrence (yes, no) during the 80-day study period of GVHD treatment failure defined as use of prednisone or equivalent IV corticosteroids at doses higher than stated in the protocol, or use of any additional other glucocorticoid (including unblinded BDP) or addition of other immunosuppressant medications, in response to uncontrolled signs or symptoms of GVHD|Day 80|Data was not analyzed as the study was terminated due to futility|||||
795988|NCT00926588|Primary|Brief Pain Inventory (Pain)|The full scale name is the Brief Pain Inventory. This 11-item scale measures self-reported pain severity and interference. It consists of 4 pain severity items and 7 pain interference items. Each item is scored from 0 (no pain) to 10 (worse pain imaginable). There is a pain severity score (average of 4 pain severity items), pain interference score (average of 7 pain interference items), and total pain score (average of all 11 items). For all 3 scores, 0 represents the best score (i.e., least pain) and 10 represents the worst score (i.e., greatest pain).|1 year|||units on a scale||Standard Deviation|Mean
795989|NCT00927069|Secondary|Total Number of Adverse Events for All Patients in the Study.|Safety of adalimumab in patients with plaque psoriasis that showed an unsatisfactory response after at least 3 months of therapy with etanercept|24 weeks|The analysis was intent to treat (ITT) and inputed Last observation carried forward (LOCF)||Adverse events|||Number
795990|NCT00927069|Secondary|Number of Patients From Group A Who Achieve a Physician's Global Assessment (PGA) of Clear or Almost Clear at Week 24 After a Dose Increase to 40mg Adalimumab Every Week.|"Efficacy of adalimumab in patients from Group A who achieve a Physician's Global Assessment (PGA) of clear or almost clear at Week 24.
Clear is defined by no plaque elevation above normal skin. There is no scale. Erythema is perceptible as hyperpigmentation, pigmented macules, diffuse faint pink or red coloration.
Almost Clear is defined as follows: It is possible but difficult to ascertain whether there is a slight elevation above normal skin. There is scaling in the form of surface dryness with some white coloration. Erythema is up to a difinite red coloration."|24 weeks|The analysis was intent to treat (ITT) and inputed Last observation carried forward (LOCF)||Participants|||Number
795991|NCT00927069|Secondary|Number of Patients From Group B Who Achieve a Physician's Global Assessment (PGA) of Clear or Almost Clear at Week 24 After a Dose Increase to 40mg Adalimumab Every Week.|"Efficacy of adalimumab in patients from Group B who achieve a Physician's global assessment (PGA) of clear or almost clear at Week 24.
Clear is defined by no plaque elevation above normal skin. There is no scale. Erythema is perceptible as hyperpigmentation, pigmented macules, diffuse faint pink or red coloration.
Almost Clear is defined as follows: It is possible but difficult to ascertain whether there is a slight elevation above normal skin. There is scaling in the form of surface dryness with some white coloration. Erythema is up to a difinite red coloration."|24 weeks|The analysis was intent to treat (ITT) and inputed Last observation carried forward (LOCF)||Participants|||Number
795992|NCT00927069|Secondary|Number of Patients From Group A Who Achieve a Physician's Global Assessment (PGA) of Clear or Almost Clear at Week 12.|"Efficacy of adalimumab in patients from Group A who achieve a Physician's Global Assessment (PGA) of clear or almost clear at week 12.
Clear is defined by no plaque elevation above normal skin. There is no scale. Erythema is perceptible as hyperpigmentation, pigmented macules, diffuse faint pink or red coloration.
Almost Clear is defined as follows: It is possible but difficult to ascertain whether there is a slight elevation above normal skin. There is scaling in the form of surface dryness with some white coloration. Erythema is up to a difinite red coloration."|12 weeks|The analysis was intent to treat (ITT) and inputed Last observation carried forward (LOCF)||Participants|||Number
795993|NCT00927069|Primary|Number of Patients From Group B Who Achieve a Physician's Global Assessment (PGA) of Clear or Almost Clear at Week 12.|"Efficacy of adalimumab 40 mg every other week in patients in Group B by calculating the number of patients who achieve a PGA of clear or almost clear at Week 12.
Clear is defined by no plaque elevation above normal skin. There is no scale. Erythema is perceptible as hyperpigmentation, pigmented macules, diffuse faint pink or red coloration.
Almost Clear is defined as follows: It is possible but difficult to ascertain whether there is a slight elevation above normal skin. There is scaling in the form of surface dryness with some white coloration. Erythema is up to a difinite red coloration."|12 weeks|The analysis was intent to treat (ITT) and inputed Last observation carried forward (LOCF)||Participants|||Number
796017|NCT00927186|Secondary|Percentage of Eroded Surface/Bone Surface (ES/BS) in the Endocortical Compartment of Iliac Crest Bone Biopsies at 6 and 24 Months|Eroded surface/bone surface (ES/BS) in the endocortical compartment is the fraction of the entire trabecular surface occupied by resorption bays, including both those with and without osteoclasts. It is an indicator of bone resorption.|6 and 24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had ES/BS analysis of the EC at 6 and 24 months.||percentage of surface||Inter-Quartile Range|Median
795994|NCT00927082|Secondary|Number of Participants With Marked Laboratory Abnormalities|Marked abnormality of laboratory parameters is defined as the value which is outside the defined reference range of that respective parameter. Roche’s following reference ranges for laboratory test parameters were used for the analysis: Hemoglobin (reference range: 110-200 grams/liter[g/L]), White blood cells (WBC) (3.0-18.0 ^10^9/L), Platelets (100-550 ^10^9/L), Neutrophils (1.50-9.25 ^10^9/L), Prothrombin time (PT) Normal ratio (n.d.-2.00), Alkaline phosphatase (0-220 units/liter [U/L]), Alanine aminotransferase (0-110 U/L), Aspartate transaminase (0-80 U/L), Total bilirubin (0-34 micromole/liter [umol/L]), Gamma-glutamyl transpeptidase (GGT) (0-190 U/L), Blood urea nitrogen (BUN) (0.0-14.3 millimole/liter [mmol/L]), Creatinine (0-154 umol/L), Total Protein (55-87 g/L), Albumin (30.0-n.d. g/L), Potassium (2.9-5.8 mmol/L), Sodium (130-150 mmol/L), Calcium (2.00-2.90 mmol/L), Uric acid (0-600 umol/L). It includes marked abnormalities observed during Study WV19432 and FU study MV22430|Up to 5-year FU period|The safety analysis population included participants who had received at least one dose of study medication in Study WV19432, had at least one visit in study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants in the safety population switched treatment groups.||Participants|||Number
795995|NCT00927082|Secondary|Number of Participants With Clinically Significant Events Related to Chronic Hepatitis B (CHB)|Clinically significant events were defined as one or more of the following: Hepatocellular carcinoma, hepatic decompensation, CHB-related death, hepatic transplant, marked elevation of serum ALT of >10 x upper limit of normal (ULN).|Up to 5-year FU period|The safety analysis population included participants who had received at least one dose of study medication in Study WV19432, had at least one visit in study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants in the safety population switched treatment groups.||Participants|||Number
795996|NCT00927082|Secondary|Number of Participants Who Received Treatment With Antiviral, Immunomodulatory, Anti-inflammatory or Herbal/Botanical/Other Treatments for Chronic Hepatitis B|Participants who required additional treatments specifically to treat CHB, associated laboratory test abnormalities and associated symptoms in this long-term observation in the study were reported. Receipt of such treatment did not require participant withdrawal from further participation.|Up to 5-year FU period|The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.||Participants|||Number
795997|NCT00927082|Secondary|Quantitative HBsAg|Quantitative HBsAg assay is a diagnostic test for assessing the amount of the HBsAg in chronic Hepatitis B participants. Missing values were counted as non-response.|Annually, for up to 5 years|The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.||log10 IU/mL||Standard Deviation|Mean
795998|NCT00927082|Secondary|Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 80 International Unit/Milliliter (IU/mL)|The percentage of participants with HBV-DNA suppression < 80 IU/mL. HBV DNA is the genetic material that carries the blueprint of the virus. The measure of HBV DNA in blood indicates how rapidly the virus is replicating in liver. Missing values were counted as non-response.|Annually, for up to 5 years|The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.||Percentage of participants||95% Confidence Interval|Number
795999|NCT00927082|Secondary|Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 2,000 International Unit/Milliliter (IU/mL)|The percentage of participants with HBV-DNA suppression < 2,000 IU/mL. HBV DNA is the genetic material that carries the blueprint of the virus. The measure of HBV DNA in blood indicates how rapidly the virus is replicating in liver. Missing values were counted as non-response.|Annually, for up to 5 years|The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.||Percentage of participants||95% Confidence Interval|Number
796000|NCT00927082|Secondary|Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 20,000 International Unit/Milliliter (IU/mL).|The percentage of participants with HBV-DNA suppression < 20,000 IU/mL. HBV DNA is the genetic material that carries the blueprint of the virus. The measure of HBV DNA in blood indicates how rapidly the virus is replicating in liver. Missing values were counted as non-response.|Annually, for up to 5 years|The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.||Percentage of participants||95% Confidence Interval|Number
796001|NCT00927082|Primary|Percentage of Participants With HBsAg Loss|HBsAg loss is defined as the absence of HBsAg (i.e. a negative result for HBsAg). Missing values were counted as non-response.|Annually, for up to 5 years|The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.||Percentage||95% Confidence Interval|Number
796002|NCT00927082|Secondary|Percentage of Participants With Normalised Alanine Transaminase (ALT)|Alanine Transaminase is an enzyme found mainly in liver and is measured to check if the liver is damaged or diseased. In case of liver damage or disease, the liver releases ALT into the blood stream and the ALT levels increase. Missing values were counted as non-response.|Annually, for up to 5 years|The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.||Percentage of participants||95% Confidence Interval|Number
796003|NCT00927082|Secondary|Percentage of Participants With Presence of Anti-HBs|The presence of anti-HBs is defined as antibody produced against HBsAg.It is generally interpreted as indicating recovery and immunity from HBV infection. Missing values were counted as non-response.|Annually, for up to 5 years|The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.||Percentage of participants||95% Confidence Interval|Number
796004|NCT00927082|Secondary|Percentage of Participants With Presence of Anti-Hepatitis B Envelope Antigen (HBe).|The presence of anti-HBe is defined as antibody produced against e antigen in HBeAg. Seroconversion from e antigen to e antibody (anti-HBe) is a predictor of long-term clearance of hepatitis B virus (HBV) in participants undergoing antiviral therapy and indicates lower levels of HBV, and therefore lower infectivity. Missing values were counted as non-response.|Annually, for up to 5 years|The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.||Percentage of participants||95% Confidence Interval|Number
796005|NCT00927082|Secondary|Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion.|HBsAg seroconversion was defined as the absence of HBsAg (a negative result for HBsAg) and the presence of anti-HBs (a positive result for anti-HBs). Missing values were counted as non-response.|Annually, for up to 5 years|The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.||Percentage of participants||95% Confidence Interval|Number
796006|NCT00927082|Secondary|Percentage of Participants With HBeAg Loss.|HBeAg loss is defined as the absence of HBeAg (i.e. a negative result for HBeAg). Missing values were counted as non-response.|Annually, for up to 5 years|The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.||Percentage of participants||95% Confidence Interval|Number
796007|NCT00927082|Primary|Percentage of Participants With Hepatitis B Envelope Antigen (HBeAg) Seroconversion.|HBeAg seroconversion was defined as the absence of HBeAg (a negative result for HBeAg) and the presence of anti-HBe (a positive result for anti-HBe). Missing values were counted as non-response.|Annually, for up to 5 years|The Per Protocol (PP) population included participants who satisfied key inclusion/exclusion criteria of Study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for Study MV22430. Analysis was performed per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.||Percentage of participants||95% Confidence Interval|Number
796008|NCT00927095|Primary|Pre-Post Change in Premenstrual Symptom Severity|"Pre-post change (pre minus post) in mean premenstrual week severity of the worst emotional symptom as measured using the Daily Record of Severity of Problems items 1-8. Worst symptom for each individual was defined as the symptom in the baseline month demonstrating the highest mean severity during the premenstrual week. Mean premenstrual week severity scores were calculated to correspond to mean ratings; therefore, the mean premenstrual severity values ranged as follows: 1=Not at All, 2=Minimal, 3=Mild, 4=Moderate, 5=Severe, 6=Extreme. The change variable presented here is calculated as follows: mean rating on the individual's worst symptom during the premenstrual week at baseline minus mean rating during the premenstrual week during the last on-treatment cycle. Therefore, higher values on this outcome variable correspond to greater reductions in premenstrual symptoms across the trial."|monthly|||units on a scale||Standard Deviation|Mean
796009|NCT00927160|Secondary|Rehospitalization Rate|30 days for readmission rate|30 days|||percentage of particpants|||Number
796010|NCT00927160|Primary|Length of Hospital Stay||Depending on hospital stay|||days||Standard Deviation|Mean
796011|NCT00927186|Secondary|Change From Baseline in Serum Osteocalcin (OC) at Month 12 Endpoint|OC is a measure of osteoblast function.|Baseline, 12 months|All participants who received at least one dose of study drug, had baseline and 12 months OC measurements.||microgram/liter (µg/L)||Inter-Quartile Range|Median
796012|NCT00927186|Secondary|Change From Baseline in Serum Osteocalcin (OC) at Month 1, 3, and 6 Endpoint|OC is a measure of osteoblast function.|Baseline, 1, 3, 6 months|All randomized participants who received at least one dose of study drug with available biochemical marker of bone turnover data.||µg/L||Inter-Quartile Range|Median
796013|NCT00927186|Secondary|Change From Baseline in Serum Procollagen Type I N-Terminal Propeptide (PINP) at Month 12 Endpoint|PINP is a measure of bone formation.|Baseline, 12 months|All participants who received at least one dose of study drug, had baseline and 12 months PINP measurement.||microgram/liter (µg/L)||Inter-Quartile Range|Median
796014|NCT00927186|Secondary|Change From Baseline in Serum Procollagen Type I N-Terminal Propeptide (PINP) at Month 1, 3 and 6 Endpoint|PINP is a measure of bone formation.|Baseline, 1, 3, 6 months|All randomized participants who received at least one dose of study drug with available biochemical marker of bone turnover data.||microgram/Liter (µg/L)||Inter-Quartile Range|Median
796015|NCT00927186|Secondary|Change From Baseline in Serum Carboxyterminal Cross-Linking Telopeptide of Type I Collagen (CTX) at Month 12 Endpoint|CTX is a measure of bone resorption.|Baseline, 12 months|All participants who received at least one dose of study drug, had baseline and 12 months CTX measurement.||nanogram/milliliter (ng/mL)||Inter-Quartile Range|Median
796016|NCT00927186|Secondary|Change From Baseline in Serum Carboxyterminal Cross-Linking Telopeptide of Type I Collagen (CTX) at Month 1, 3 and 6 Endpoint|CTX is a measure of bone resorption.|Baseline, 1, 3, 6 months|All randomized participants who received at least one dose of study drug with available biochemical marker of bone turnover data.||nanogram/milliliter (ng/mL)||Inter-Quartile Range|Median
796190|NCT00928057|Other Pre-specified|Percentage of Subjects With at Least One Leakage Event|After each insulin injection with a study pen needle, subjects recorded in their study diary if they observed insulin leakage from the injection site. Subjects were not required to make a diary entry if there was no leakage.|each PN was used for 3 weeks|||percent of subjects|||Number
796018|NCT00927186|Secondary|Percentage of Eroded Surface/Bone Surface (ES/BS) in the Cancellous Compartment of Iliac Crest Bone Biopsies at 24 Months|Eroded surface/bone surface (ES/BS) in the cancellous compartment is the fraction of the entire trabecular surface occupied by resorption bays, including both those with and without osteoclasts. It is an indicator of bone resorption.|24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had ES/BS analysis of the CC at 24 months.||percentage of surface||Inter-Quartile Range|Median
796019|NCT00927186|Secondary|Percentage of Eroded Surface/Bone Surface (ES/BS) in the Cancellous Compartment of Iliac Crest Bone Biopsies at 6 Months|Eroded surface/bone surface (ES/BS) in the cancellous compartment is the fraction of the entire trabecular surface occupied by resorption bays, including both those with and without osteoclasts. It is an indicator of bone resorption.|6 months|All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.||percentage of surface||Inter-Quartile Range|Median
796020|NCT00927186|Secondary|Wall Thickness (WTh.) in the Endocortical Compartment of Iliac Crest Bone Biopsies at 6 and 24 Months|Wall thickness (WTh.) in the endocortical compartment is measured as the mean distance from the cement line to the marrow space of completed trabecular bone packets.|6 and 24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had WTh. analysis of the EC at 6 and 24 months.||micrometer (µm)||Inter-Quartile Range|Median
796021|NCT00927186|Secondary|Wall Thickness (WTh.) in the Cancellous Compartment of Iliac Crest Bone Biopsies at 24 Months|Wall thickness (WTh.) in the cancellous compartment is measured as the mean distance from the cement line to the marrow space of completed trabecular bone packets.|24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had WTh. analysis of the CC at 24 months.||micrometer (µm)||Inter-Quartile Range|Median
796022|NCT00927186|Secondary|Wall Thickness (WTh.) in the Cancellous Compartment of Iliac Crest Bone Biopsies at 6 Months|Wall thickness (WTh.) in the cancellous compartment is measured as the mean distance from the cement line to the marrow space of completed trabecular bone packets.|6 months|All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.||µm||Inter-Quartile Range|Median
796023|NCT00927186|Secondary|Osteoid Thickness (OTh.) in the Endocortical Compartment of Iliac Crest Bone Biopsies at 6 and 24 Months|Osteoid thickness (OTh.) in the endocortical compartment is a measure of the average thickness of osteoid seams.|6 and 24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had OTh. analysis of the EC at 6 and 24 months.||micrometer (µm)||Inter-Quartile Range|Median
796024|NCT00927186|Secondary|Osteoid Thickness (OTh.) in the Cancellous Compartment of Iliac Crest Bone Biopsies at 24 Months|Osteoid thickness (OTh.) in the cancellous compartment is a measure of the average thickness of osteoid seams.|24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had OTh. analysis of the CC at 24 months.||micrometer (µm)||Inter-Quartile Range|Median
796025|NCT00927186|Secondary|Osteoid Thickness (OTh.) in the Cancellous Compartment of Iliac Crest Bone Biopsies at 6 Months|Osteoid thickness (OTh.) in the cancellous compartment is a measure of the average thickness of osteoid seams.|6 months|All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.||micrometer (µm)||Inter-Quartile Range|Median
796026|NCT00927186|Secondary|Percentage of Osteoid Surface (OS)/Bone Surface (BS) in the Endocortical Compartment of Iliac Crest Bone Biopsies at 6 and 24 Months|Osteoid surface (OS) in the endocortical compartment is the fraction (%) of the entire trabecular bone surface that is covered by osteoid.|6 and 24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had OS/BS analysis of the EC at 6 and 24 months.||percentage of surface||Inter-Quartile Range|Median
796027|NCT00927186|Secondary|Percentage of Osteoid Surface (OS)/Bone Surface (BS) in the Cancellous Compartment of Iliac Crest Bone Biopsies at 24 Months|Osteoid surface (OS) in the cancellous compartment is the fraction (%) of the entire trabecular bone surface that is covered by osteoid.|24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had OS/BS analysis of the CC at 24 months.||percentage of surface||Inter-Quartile Range|Median
796028|NCT00927186|Secondary|Percentage of Osteoid Surface (OS)/Bone Surface (BS) in the Cancellous Compartment of Iliac Crest Bone Biopsies at 6 Months|Osteoid surface (OS) in the cancellous compartment is the fraction (%) of the entire trabecular bone surface that is covered by osteoid.|6 months|All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.||percentage of surface||Inter-Quartile Range|Median
796029|NCT00927186|Secondary|Percentage of Osteoid Volume (OV)/Bone Volume (BV) in the Cancellous Compartment of Iliac Crest Bone Biopsies at 24 Months|Osteoid volume (OV) in the cancellous compartment is the percent of a given volume of bone tissue that consists of unmineralized bone (osteoid).|24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had OV/BV analysis of the CC at 24 months.||percentage of volume||Inter-Quartile Range|Median
796030|NCT00927186|Secondary|Percentage of Osteoid Volume (OV)/Bone Volume (BV) in the Cancellous Compartment of Iliac Crest Bone Biopsies at 6 Months|Osteoid volume (OV) in the cancellous compartment is the percent of a given volume of bone tissue that consists of unmineralized bone (osteoid).|6 months|All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.||percentage of volume||Inter-Quartile Range|Median
796031|NCT00927186|Secondary|Average Length of Tetracycline Double Labels in the Endocortical Compartment of Iliac Crest Bone Biopsies at 6 and 24 Months|The length of tetracycline double labels is a measure of the extent of bone formation in the endocortical compartment within individual remodeling units and is measured in millimeters (mm). Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation.|6 and 24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had length of tetracycline double labels analysis of the endocortical compartment at 6 and 24 months.||millimeter (mm)||Inter-Quartile Range|Median
796263|NCT00928408|Primary|Achievement of a Reduction From Baseline of Albumin-corrected Serum Calcium ≥ 0.25 mmol/L (1 mg/dL) at Month 6|Baseline is pre-cinacalcet.|Month 6|Full Analysis Set - Participants with Observed Data||Participants|||Number
796278|NCT00928408|Primary|Cinacalcet Dose|Cinacalcet dose at initiation of treatment|Initiation of treatment|Full Analysis Set||mg/day||95% Confidence Interval|Mean
796032|NCT00927186|Secondary|Average Length of Tetracycline Double Labels in the Cancellous Compartment of Iliac Crest Bone Biopsies at 24 Months|The length of tetracycline double labels is a measure of the extent of bone formation in the cancellous compartment within individual remodeling units and is measured in millimeters (mm). Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation.|24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had length of tetracycline double labels analysis of the cancellous compartment at 24 months.||millimeter (mm)||Inter-Quartile Range|Median
796033|NCT00927186|Secondary|Average Length of Tetracycline Double Labels in the Cancellous Compartment of Iliac Crest Bone Biopsies at 6 Months|The length of tetracycline double labels is a measure of the extent of bone formation in the cancellous compartment within individual remodeling units and is measured in millimeters (mm). Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation.|6 months|All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.||millimeter (mm)||Inter-Quartile Range|Median
796034|NCT00927186|Secondary|Number of Samples With Single or Double Tetracycline Labels, Single and Double Labels, or No Tetracycline Labels in the Endocortical Compartment of Iliac Crest Bone Biopsies at 6 and 24 Months|Number of samples with single or double tetracycline labels, both single and double labels, or no labels in the endocortical compartment were compared between teriparatide and zoledronic acid treated participants. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation.|6 and 24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy of the endocortical compartment at 6 and 24 months.||samples|||Number
796035|NCT00927186|Secondary|Number of Samples With Single or Double Tetracycline Labels, Single and Double Labels, or No Tetracycline Labels in the Cancellous Compartment of Iliac Crest Bone Biopsies at 24 Months|Number of samples with single or double tetracycline labels, both single and double labels, or no labels in the cancellous compartment were compared between teriparatide and zoledronic acid treated participants. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation.|24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy of the cancellous compartment at 24 months.||samples|||Number
796036|NCT00927186|Secondary|Number of Samples With Single or Double Tetracycline Labels, Single and Double Labels, or No Tetracycline Labels in the Cancellous Compartment of Iliac Crest Bone Biopsies at 6 Months|Number of samples with single or double tetracycline labels, both single and double labels, or no labels in the cancellous compartment were compared between teriparatide and zoledronic acid treated participants. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation.|6 months|All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.||samples|||Number
796037|NCT00927186|Secondary|Percent of Single or Double Tetracycline Labels Per Bone Surface (sLS/BS), (dLS/BS) in the Endocortical Compartment of Iliac Crest Bone Biopsies at 6 and 24 Months|The percent of single or double tetracycline labels per bone surface (sLS/BS, dLS/BS) in the endocortical compartment. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation.|6 and 24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had sLS/BS and dLS/BS analysis of the endocortical compartment at 6 and 24 months.||percentage of tetracycline labels||Inter-Quartile Range|Median
796038|NCT00927186|Secondary|Percent of Single or Double Tetracycline Labels Per Bone Surface (sLS/BS), (dLS/BS) in the Cancellous Compartment of Iliac Crest Bone Biopsies at 24 Months|The percent of single or double tetracycline labels per bone surface (sLS/BS, dLS/BS) in the cancellous compartment. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation.|24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had sLS/BS and dLS/BS analysis of the cancellous compartment at 24 months.||percentage of tetracycline labels||Inter-Quartile Range|Median
796039|NCT00927186|Secondary|Percent of Single or Double Tetracycline Labels Per Bone Surface (sLS/BS), (dLS/BS) in the Cancellous Compartment of Iliac Crest Bone Biopsies at 6 Months|The percent of single or double tetracycline labels per bone surface (sLS/BS, dLS/BS) in the cancellous compartment. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation.|6 months|All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.||percentage of tetracycline labels||Inter-Quartile Range|Median
796092|NCT00927472|Secondary|Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Modified ITT (Non LOCF)|"Treatment Success in the Modified ITT (non LOCF)
The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment.
The evaluations in the Modified ITT was considered supportive."|3 weeks|"The evaluations in the Modified ITT was considered supportive. The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment.
Based on the protocol predefined imputation of missing efficacy data, the effective sample size = 199; frequency missing = 33."||percentage of subjects|||Number
796040|NCT00927186|Secondary|Active Formation Period (a.FP) in the Endocortical Compartment (EC) of Iliac Crest Bone Biopsies at 6 and 24 Months|a. FP in EC is the mean time required to rebuild a new bone structural unit, calculated as wall thickness divided by MAR. Participants were given T for two 3 day-periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|6 and 24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had a.FP analysis of the EC at 6 and 24 months.||year||Inter-Quartile Range|Median
796041|NCT00927186|Secondary|Active Formation Period (a.FP) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 24 Months|a. FP in CC is the mean time required to rebuild a new bone structural unit, calculated as wall thickness divided by MAR. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had a.FP analysis of the CC at 24 months.||year||Inter-Quartile Range|Median
796042|NCT00927186|Secondary|Active Formation Period (a.FP) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 6 Months|a. FP in CC is the mean time required to rebuild a new bone structural unit, calculated as wall thickness divided by MAR. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|6 months|All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.||year||Inter-Quartile Range|Median
796043|NCT00927186|Secondary|Total Formation Period (Tt.FP) in the Endocortical Compartment (EC) of Iliac Crest Bone Biopsies at 6 and 24 Months|Tt.FP in EC is a measure of bone formation and is calculated as wall thickness divided by Aj.AR. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|6 and 24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had Tt.FP analysis of the EC at 6 and 24 months.||year||Inter-Quartile Range|Median
796044|NCT00927186|Secondary|Total Formation Period (Tt.FP) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 24 Months|Tt.FP in CC is a measure of bone formation and is calculated as wall thickness divided by Aj.AR. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had Tt.FP analysis of the CC at 24 months.||year||Inter-Quartile Range|Median
796045|NCT00927186|Secondary|Total Formation Period (Tt.FP) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 6 Months|Tt.FP in CC is a measure of bone formation and is calculated as wall thickness divided by Aj.AR. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|6 months|All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.||year||Inter-Quartile Range|Median
796046|NCT00927186|Secondary|Osteoid Maturation Time (Omt) in the Endocortical Compartment (EC) of Iliac Crest Bone Biopsies at 6 and 24 Months|Omt in EC is the period between the onset of deposition and onset of mineralization of a given amount of osteoid. Omt is calculated as O.Th divided by MAR. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|6 and 24 Months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had Omt analysis of the EC at 6 and 24 months.||day||Inter-Quartile Range|Median
796047|NCT00927186|Secondary|Osteoid Maturation Time (Omt) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 24 Months|Omt in CC is the period between the onset of deposition and onset of mineralization of a given amount of osteoid. Omt is calculated as O.Th divided by MAR. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had Omt analysis of the CC at 24 months.||day||Inter-Quartile Range|Median
796048|NCT00927186|Secondary|Osteoid Maturation Time (Omt) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 6 Months|Omt in CC is the period between the onset of deposition and onset of mineralization of a given amount of osteoid. Omt is calculated as O.Th divided by MAR. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|6 months|All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.||day||Inter-Quartile Range|Median
796264|NCT00928408|Primary|Achievement of a Reduction From Baseline of Albumin-corrected Serum Calcium ≥ 0.25 mmol/L (1 mg/dL) at Month 3|Baseline is pre-cinacalcet.|Month 3|Full Analysis Set - Participants with Observed Data||Participants|||Number
796049|NCT00927186|Secondary|Mineralization Lag Time (Mlt) in the Endocortical Compartment (EC) of Iliac Crest Bone Biopsies at 6 and 24 Months|Mlt in EC is the period between deposition and subsequent mineralization of osteoid. Mlt is calculated as O.Th divided by Aj.AR. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|6 and 24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had Mlt analysis of the EC at 6 and 24 months.||day||Inter-Quartile Range|Median
796050|NCT00927186|Secondary|Mineralization Lag Time (Mlt) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 24 Months|Mlt in CC is the period between deposition and subsequent mineralization of osteoid. Mlt is calculated as O.Th divided by Aj.AR. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had Mlt analysis of the CC at 24 months.||day||Inter-Quartile Range|Median
796051|NCT00927186|Secondary|Mineralization Lag Time (Mlt) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 6 Months|Mlt in CC is the period between deposition and subsequent mineralization of osteoid. Mlt is calculated as Osteoid Thickness (O.Th) divided by Aj.AR. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|6 months|All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.||day||Inter-Quartile Range|Median
796052|NCT00927186|Secondary|Adjusted Apposition Rate (Aj.AR) in the Endocortical Compartment (EC) of Iliac Crest Bone Biopsies at 6 and 24 Months|Aj.AR in EC is MAR averaged over the entire osteoid surface and in a steady state is an estimate of the mean rate of matrix apposition. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|6 and 24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had Aj.AR analysis of the EC at 6 and 24 months.||micrometer (µm)/day||Inter-Quartile Range|Median
796053|NCT00927186|Secondary|Adjusted Apposition Rate (Aj.AR) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 24 Months|Aj.AR in CC is MAR averaged over the entire osteoid surface and in a steady state is an estimate of the mean rate of matrix apposition. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had Aj.AR analysis of the CC at 24 months.||micrometer (µm)/day||Inter-Quartile Range|Median
796054|NCT00927186|Secondary|Adjusted Apposition Rate (Aj.AR) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 6 Months|Aj.AR in CC is MAR averaged over the entire osteoid surface and in a steady state is an estimate of the mean rate of matrix apposition. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|6 months|All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.||µm/day||Inter-Quartile Range|Median
796055|NCT00927186|Secondary|Mineral Apposition Rate (MAR) in the Endocortical Compartment (EC) of Iliac Crest Bone Biopsies at 6 and 24 Months|MAR in EC is a measure of the linear rate of production of mineralized bone matrix by osteoblasts and is measured by the mean distance between two consecutive labels divided by the time interval. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|6 and 24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had MAR analysis of the EC at 6 and 24 months.||micrometer (µm/day)||Inter-Quartile Range|Median
796056|NCT00927186|Secondary|Mineral Apposition Rate (MAR) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 24 Months|MAR in CC is a measure of the linear rate of production of mineralized bone matrix by osteoblasts and is measured by the mean distance between two consecutive labels divided by the time interval. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had MAR analysis of the CC at 24 months.||micrometer (µm)/day||Inter-Quartile Range|Median
796091|NCT00927394|Primary|Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure (MASBP) at Week 8|The 24-hour ambulatory systolic blood pressure was evaluated at baseline (Week 0) and post-baseline visits. The mean hourly systolic blood pressure was calculated at post-dosing hours 1-24 for each patient. The MASBP for each patient was calculated by averaging the patient’s available hourly means for post-dosing hours 1-24.|baseline, week 8|Full Analysis Set 2 (FAS 2) with ambulatory blood pressure monitoring (ABPM)— Consists of all patients in Cohort 2 to whom study treatments were assigned through randomization and who had both valid baseline and post-baseline ambulatory blood pressure monitoring (ABPM)assessments.||mmHg||Standard Deviation|Mean
796057|NCT00927186|Secondary|Mineral Apposition Rate (MAR) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 6 Months|MAR in CC is a measure of the linear rate of production of mineralized bone matrix by osteoblasts and is measured by the mean distance between two consecutive T labels divided by the time interval. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|6 months|All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.||micrometer (µm)/day||Inter-Quartile Range|Median
796058|NCT00927186|Secondary|Bone Formation Rate (BFR) in the Endocortical Compartment (EC) of Iliac Crest Bone Biopsies at 6 and 24 Months|BFR in EC is the volume of mineralized bone formed per unit surface bone per unit time (mm³/mm²/year); calculated as MAR times MS/BS. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|6 and 24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had BFR analysis of EC at 6 and 24 months.||mm³/mm²/year||Inter-Quartile Range|Median
796059|NCT00927186|Secondary|Bone Formation Rate (BFR) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 24 Months|BFR in CC is the volume of mineralized bone formed per unit surface bone per unit time (mm³/mm²/year); calculated as MAR times MS/BS. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had BFR analysis of the CC at 24 months.||mm³/mm²/year||Inter-Quartile Range|Median
796060|NCT00927186|Secondary|Bone Formation Rate (BFR) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 6 Months|BFR in CC is the volume of mineralized bone formed per unit surface bone per unit time (cubic millimeter/square millimeter/year [mm³/mm²/year]); calculated as mineral apposition rate (MAR) times MS/BS. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|6 months|All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.||mm³/mm²/year||Inter-Quartile Range|Median
796061|NCT00927186|Secondary|Activation Frequency (Ac.f) in the Endocortical Compartment (EC) of Iliac Crest Bone Biopsies at 6 and 24 Months|Ac.f in EC represents the frequency of activation of new remodeling cycles on the bone surface (BFR/BS divided by wall thickness) and is expressed in units of new cycles per unit of time. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|6 and 24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had Ac.f analysis of the EC at 6 and 24 months.||new cycles/year||Inter-Quartile Range|Median
796062|NCT00927186|Secondary|Activation Frequency (Ac.f) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 24 Months|Ac.f in CC represents the frequency of activation of new remodeling cycles on the bone surface (BFR/BS divided by wall thickness) and is expressed in units of new cycles per unit of time. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had Ac.f analysis of the CC at 24 months.||new cycles/year||Inter-Quartile Range|Median
796063|NCT00927186|Secondary|Activation Frequency (Ac.f) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 6 Months|Ac.f in CC represents the frequency of activation of new remodeling cycles on BS (bone formation rate [BFR]/BS divided by wall thickness) and is expressed in units of new cycles per unit of time. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 micrometer (µm)/day or counted as missing.|6 months|All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.||new cycles/year||Inter-Quartile Range|Median
796064|NCT00927186|Secondary|Mineralizing Surface/Bone Surface(MS/BS) in the Endocortical Compartment (EC) of Iliac Crest Bone Biopsies at 6 and 24 Months|MS/BS in EC is a measure of the proportion of BS on which new mineralized bone is deposited at the time of tetracycline (T) labeling and is calculated as sum of total extent of double label (DL) plus half the extent of single label (SL) divided by BS. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in the biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under a microscope. DL indicates active bone formation, SL or no label (NL) suggests suppression of bone formation.|6 and 24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had MS/BS analysis of the EC at 6 and 24 months.||percentage of surface||Inter-Quartile Range|Median
796147|NCT00927862|Secondary|The Percent of INRs ≥4 or ≤1.5 in the Pharmacogenetic (PG)-Guided Dosing Arms and the Parallel Control Arm|What is reported is the percent of patients with an INR ≥4 or ≤1.5 at the end of follow-up.|3 months (baseline to 3 months or to end of warfarin therapy, whichever occurs first)|Patients who were enrolled in CoumaGen-II and thus, received their warfarin dosing by the PG-dosing algorithms (standard or modified IWPC warfarin algorithms) were compared to parallel controls.||percent||Standard Deviation|Mean
796065|NCT00927186|Secondary|Mineralizing Surface/Bone Surface (MS/BS) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 24 Months|MS/BS in CC is a measure of the proportion of BS on which new mineralized bone is deposited at the time of tetracycline (T) labeling and is calculated as sum of total extent of double label (DL) plus half the extent of single label (SL) divided by BS. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in the biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under a microscope. DL indicates active bone formation, SL or no label (NL) suggests suppression of bone formation.|24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had MS/BS analysis of the CC at 24 months.||percentage of surface||Inter-Quartile Range|Median
796066|NCT00927186|Primary|Mineralizing Surface/Bone Surface (MS/BS) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 6 Months|MS/BS in CC is a measure of the proportion of BS on which new mineralized bone is deposited at the time of tetracycline (T) labeling and is calculated as sum of total extent of double label (DL) plus half the extent of single label (SL) divided by BS. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in the biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under a microscope. DL indicates active bone formation, SL or no label (NL) suggests suppression of bone formation.|6 months|All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.||percentage of surface||Inter-Quartile Range|Median
796067|NCT00927251|Primary|Number of Participants With Left Ventricular (LV)Lead Related Complications|A LV lead related complication occurs when an invasive procedure is needed to correct an adverse event related to the LV lead.|Implant to one-month post implant|All subjects implanted with the lead who had completed their one-month post-implant/or a later follow-up visit, or have had a complication by the one-month post-implant visit, were included in the analysis. A complication is defined as an Adverse Event that results in death, any termination of significant device function or invasive intervention||participants|||Number
796068|NCT00927264|Secondary|Number of Participants Who Report Endorsing a Home Smoking Ban|Number of participants endorsing presence of home smoking ban|Measured at baseline, 3, 6 and 12 months|The number analyzed differs at each time point due to missing data. Reasons for missing data include unable to contact||Participants|||Count of Participants
796069|NCT00927264|Secondary|Health Care Utilization by Child- Self Report From Parent/Caregiver|Parent caregiver reported urgent care visits, number of hospitalizations, and number of emergency department visits in the 12 months prior for child enrolled in study|Measured at baseline and 3, 6 and 12 months|||Participants|||Count of Participants
796070|NCT00927264|Secondary|Respiratory Function of Child by Self Report of Parent|Number of cold infections child experienced in previous 3 months, reported by caregiver|Measured at Baseline, 3, 6, and 12 months|The number analyzed differs at each time point due to missing data. Reasons for missing include unable to contact or caregiver refused or did not fully complete survey||cold infections||Standard Deviation|Mean
796071|NCT00927264|Secondary|ETS Reduction, as Measured by Child's Cotinine Levels|Child salivary cotinine will be a measure to evaluate environmental tobacco smoke (ETS) reduction|Measured at Baseline, 3, 6 and 12 months|The number analyzed differs at each time point due to missing data. Reasons for missing include unable to contact, samples not able to be analyzed due to insufficient quantity of saliva collected, or child not available during assessment.||ng/mL||Inter-Quartile Range|Median
796072|NCT00927264|Primary|Air Nicotine Levels|Air nicotine levels were an indicator of child's exposure to environmental tobacco smoke (ETS)|Measured at Baseline, 3, 6 and 12 months|The number analyzed differs at each time point due to missing data. Reasons for missing data include unable to contact||mg/m^3||Inter-Quartile Range|Median
796073|NCT00927355|Secondary|Bone Mineral Density||6 months|||percent change from baseline to 6 months||Standard Error|Mean
796074|NCT00927355|Secondary|βCTX (Carboxy Terminal Collagen Crosslinks), Osteocalcin, and Adiponectin.||6 months|||percent change from baseline||Standard Error|Mean
796075|NCT00927355|Primary|Percent Change in Number of Osteoblast and Adipocyte Colony Forming Units Cultured From Bone Marrow Stem Cells Harvested 6 Months After Treatment With Study Drug Compared to Baseline|To determine the effect of PIO (pioglitazone) on BMSC (bone marrow stem cell) lineage choice in vivo, a bone marrow aspiration was obtained from patients at baseline and after 6 months of treatment with PIO or placebo. The bone marrow was used for ex vivo CFU-OB (Colony forming units-Osteoblast) and CFU-AD assays using the same protocol described for the in vitro studies previously. We also analyzed the number of total colonies per patient at both baseline and final visit.|6 months|||percent change from baseline to 6months||Standard Error|Mean
796076|NCT00927368|Secondary|Incremental Cost of Femoral Nerve Blocks|The incremental cost between strategies was calculated as the additional cost of one strategy to the next less costly strategy. There was no variance in the price because these prices were contracted with the hospital. The contracted price for a hospital does not change or fluctuate.|postoperative period when block is used|||dollars||Standard Deviation|Mean
796077|NCT00927368|Secondary|Block Performance Time|Block performance time, defined as the time from block start until catheter placement.|time elapsed from beginning the block to catheter placement|||seconds||95% Confidence Interval|Mean
796078|NCT00927368|Primary|Opioid Consumption|cumulative opioid consumption, where all opioids were converted to IV morphine equivalents|48 hours after surgery|||mg morphine equivalents||Inter-Quartile Range|Median
796079|NCT00927368|Primary|Time Weighted Average Verbal Response Scale Pain Score|"Time weighted average of verbal response scale (VRS) pain score on a scale from 0 (no pain) to 10 (worst pain imaginable).
Verbal Response Scale (VRS) pain scores after surgery – which ranged from 0 (no pain) to 10 (maximum intolerable pain) – were assessed every 30 minutes in the recovery area and every 4 hours thereafter up to 48 hours postoperatively. These individual measurements were averaged for each patient using a time-weighted formula. (For a given patient, the observed VRS pain score profile as a function of time was linearly interpolated and integrated using the trapezoidal rule; then, the time-weighted average was calculated as the value of this integral divided by the total monitoring time of 48 hours.)."|48 hours after surgery|||units on a scale||Standard Deviation|Mean
796173|NCT00927953|Primary|The Number of Participants Who Had At Least 1 Treatment-Related Adverse Event|Includes adverse events considered possibly, probably, or definitely related to study drug|120 days|Intention to treat (ITT)||participants|||Number
796080|NCT00927394|Secondary|Number of Patients With Adverse Events, Serious Adverse Events and Death|"Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen.
Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards."|8 weeks|Safety Set — Consisted of all patients who received at least one dose of double-blind trial medication. Patients were analyzed according to the treatment that they received.||Patients|||Number
796081|NCT00927394|Secondary|Change From Baseline in Plasma Aldosterone at Week 8||Baseline, week 8|Combined FAS included all randomized patients in Cohort 1 (FAS 1) and all randomized patients in Cohort 2 who had a valid baseline assessment of 24-hour ambulatory systolic blood pressure measurement (FAS 2). Patients with baseline and week 8 assessments were included in this analysis.||pmol/L||Standard Deviation|Mean
796082|NCT00927394|Secondary|Change From Baseline in Plasma Renin Concentration (PRC) at Week 8||Baseline, week 8|Combined FAS included all randomized patients in Cohort 1 (FAS 1) and all randomized patients in Cohort 2 who had a valid baseline assessment of 24-hour ambulatory systolic blood pressure measurement (FAS 2). Patients with baseline and week 8 assessments were included in this analysis.||ng/L||Standard Deviation|Mean
796083|NCT00927394|Secondary|Change From Baseline in Plasma Renin Activity (PRA) at Week 8||Baseline, week 8|Combined FAS included all randomized patients in Cohort 1 (FAS 1) and all randomized patients in Cohort 2 who had a valid baseline assessment of 24-hour ambulatory systolic blood pressure measurement (FAS 2). Patients with baseline and week 8 assessments were included in this analysis.||ng/mL/hr||Standard Deviation|Mean
796084|NCT00927394|Secondary|Percentage of Responders|Responders were defined as patients with MSSBP <130 mmHg or a reduction from baseline in MSSBP of >20 mmHg.Percentage of responders achieving a response at the corresponding visit was reported.|Baseline, Week 8|Combined FAS included all randomized patients in Cohort 1 (FAS 1) and all randomized patients in Cohort 2 who had a valid baseline assessment of 24-hour ambulatory systolic blood pressure measurement (FAS 2). Patients with baseline and week 8 assessments were included in this analysis.||Percentage of patients|||Number
796085|NCT00927394|Secondary|Percentage of Patients Achieving Blood Pressure Control|Blood pressure control was defined as MSSBP/MSDBP <140/90 mmHg. Percentage of patients achieving of blood pressure control at the corresponding visit was reported|8 weeks|Combined FAS included all randomized patients in Cohort 1 (FAS 1) and all randomized patients in Cohort 2 who had a valid baseline assessment of 24-hour ambulatory systolic blood pressure measurement (FAS 2). Number of patients with data at each visit were analyzed.||Percentage of patients|||Number
796086|NCT00927394|Secondary|Change From Baseline in Mean Sitting Pulse Pressure (MSPP) at Week 8|At each visit, the pulse rate was measured for 30 seconds just prior to the first sitting blood pressure measurement.|baseline, week 8|Combined FAS included all randomized patients in Cohort 1 (FAS 1) and all randomized patients in Cohort 2 who had a valid baseline assessment of 24-hour ambulatory systolic blood pressure measurement (FAS 2). Patients with baseline and week 8 data were included in this analysis. Last-observation-carried-forward (LOCF) approach was used.||mmHg||Standard Deviation|Mean
796087|NCT00927394|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)|Sitting blood pressure was measured at trough (24 hours ± 3 hours post dose) and recorded at all study visits. At the first study visit, the arm in which the highest sitting diastolic blood pressure was found was the arm used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for five minutes, systolic and diastolic blood pressures were measured 3 times using the standard mercury sphygmomanometer. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting office blood pressure for that visit.|Baseline, week 8|Combined FAS included all randomized patients in Cohort 1 (FAS 1) and all randomized patients in Cohort 2 who had a valid baseline assessment of 24-hour ambulatory systolic blood pressure measurement (FAS 2). Patients with baseline and week 8 data were included in this analysis. Last-observation-carried-forward (LOCF) approach was used.||mmHg||Standard Deviation|Mean
796088|NCT00927394|Secondary|Change From Baseline in Mean 24-hour Ambulatory Pulse Pressure (MAPP) at Week 8|The 24-hour ambulatory pulse pressure was evaluated at baseline (Week 0) and post-baseline visits.|baseline, week 8|Full Analysis Set 2 (FAS 2) with ambulatory blood pressure monitoring (ABPM)— Consists of all patients in Cohort 2 to whom study treatments were assigned through randomization and who had both valid baseline and post-baseline ambulatory blood pressure monitoring (ABPM)assessments.||mmHg||Standard Deviation|Mean
796089|NCT00927394|Secondary|Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure (MADBP) at Week 8|The 24-hour ambulatory diastolic blood pressure was evaluated at baseline (Week 0) and post-baseline visits. The mean hourly diastolic blood pressure was calculated at post-dosing hours 1-24 for each patient. The MADBP for each patient was calculated by averaging the patient's available hourly means for post-dosing hours 1-24.|baseline, week 8|Full Analysis Set 2 (FAS 2) with ambulatory blood pressure monitoring (ABPM)— Consists of all patients in Cohort 2 to whom study treatments were assigned through randomization and who had both valid baseline and post-baseline ambulatory blood pressure monitoring (ABPM)assessments.||mmHg||Standard Deviation|Mean
796090|NCT00927394|Secondary|Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP)|Sitting blood pressure was measured at trough (24 hours ± 3 hours post dose) and recorded at all study visits. At the first study visit, the arm in which the highest sitting diastolic blood pressure was found was the arm used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for five minutes, systolic and diastolic blood pressures were measured 3 times using the standard mercury sphygmomanometer. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting office blood pressure for that visit.|Baseline, week 8|Combined FAS included all randomized patients in Cohort 1 (FAS 1) and all randomized patients in Cohort 2 who had a valid baseline assessment of 24-hour ambulatory systolic blood pressure measurement (FAS 2). Patients with baseline and week 8 data were included in this analysis. Last-observation-carried-forward (LOCF) approach was used.||mmHg||Standard Deviation|Mean
796265|NCT00928408|Primary|Duration of Exposure to Cinacalcet|Time from first dose to last non-zero dose on study|12 months|Full Analysis Set||Days||Inter-Quartile Range|Median
796093|NCT00927472|Secondary|Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Modified ITT (LOCF)|"Treatment Success in the Modified ITT (LOCF)
The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment.
The evaluations in the Modified ITT was considered supportive."|3 weeks|"The evaluations was in the Modified ITT was considered supportive. The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment.
Based on the protocol predefined imputation of missing efficacy data, the effective sample size = 199; frequency missing = 33."||percentage of subjects|||Number
796094|NCT00927472|Secondary|Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the PPP|"Treatment Success in the PPP
The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment.
The evaluations in the PPP was considered supportive."|3 weeks|"The evaluations in the PPP was considered supportive The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment.
Based on the protocol predefined imputation of missing efficacy data, the effective sample size = 188; frequency missing = 33."||percentage of subjects|||Number
796095|NCT00927472|Secondary|Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Efficacy ITT (Non LOCF))|"Treatment Success in the Efficacy ITT (non LOCF)
The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment."|3 weeks|"Treatment Success was evaluated in the Efficacy ITT(non LOCF) The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment.
Based on the protocol predefined imputation of missing efficacy data, the effective sample size = 82; frequency missing = 13."||percentage of subjects|||Number
796096|NCT00927472|Primary|Proportion of All Randomized Subjects Who Were Treated and Returned for at Least One Post-treatment Visit (Non-LOCF).|"Treatment Success in the Modified ITT (non-LOCF)
The Modified ITT included all randomized subjects who were treated and returned for at least one post-treatment visit.
Subjects with missing efficacy data were included first with LOCF and then with non-LOCF"|3 weeks|Treatment Success in the Modified ITT (LOCF) The Modified ITT included all randomized subjects who were treated and returned for at least one post-treatment visit. Subjects with missing efficacy data were included first with LOCF and then with non-LOCF.||percentage of subjects|||Number
796097|NCT00927472|Primary|Proportion of All Randomized Subjects Who Were Treated and Returned for at Least One Post-treatment Visit.(LOCF)|"Treatment Success in the Modified Intention to Treat (Modified ITT) (LOCF)
The Modified ITT included all randomized subjects who were treated and returned for at least one post-treatment visit. Subjects with missing efficacy data were included first with LOCF and then with non-LOCF"|3 weeks|Treatment Success in the Modified Intention to Treat ( Modified ITT) (LOCF) The Modified ITT included all randomized subjects who were treated and returned for at least one post-treatment visit. Subjects with missing efficacy data were included first with LOCF and then with non-LOCF.||percentage of subjects|||Number
796098|NCT00927472|Primary|Proportion of Index Subjects Lice-free 14 Days After Their Last Treatment|"Treatment Success in the Per Protocol Population (PPP)
The PPP included all subjects who complied strictly with the protocol and had outcome data for all required visits. Superiority analysis in the PPP was considered to be supportive."|3 weeks|The Per-Protocol Population (PPP) included all subjects who complied strictly with the protocol and had outcome data for all required visits. Superiority analysis in the PPP was considered to be supportive.||percentage of subjects|||Number
796099|NCT00927472|Primary|Proportion of Index Subjects Lice-free 2 Weeks After Their Last Treatment|"Treatment Success in the Efficacy Intention to Treat (eITT) (No LOCF)
The primary efficacy variable was the proportion of index subjects who were considered a Treatment Success 14 days after their last treatment (Day 14 visit if only treated on Day 1, Day 21 visit if treated on Day 1 and Day 7)."|3 weeks|Treatment Success in the Efficacy ITT (No LOCF) The Efficacy ITT population was the primary population for demonstrating the superiority of the Malathion product to the active control Nix® Crème Rinse.||percentage of subjects|||Number
796100|NCT00927472|Secondary|Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Efficacy ITT (LOCF))|"Treatment Success in the Efficacy ITT (LOCF)
The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment."|3 weeks|Treatment Success in the Efficacy ITT (LOCF). The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment. Based on the protocol predefined imputation of missing efficacy data, the effective sample size = 82; frequency missing = 13.||percentage of subjects|||Number
796101|NCT00927472|Primary|Proportion of Index Subjects Free of Any of Lice 14 Days After Their Last Treatment.|"Treatment Success was evaluated using the Efficacy Intention to Treat (eITT) (LOCF) Efficacy ITT (eITT) was considered definitive.
The primary efficacy variable was the proportion of index subjects who were considered a Treatment Success 14 days after their last treatment (Day 14 visit if only treated on Day 1, Day 21 visit if treated on Day 1 and Day 7).
Index subject: 95 from 254 randomized (the youngest subject in the household who met index case criteria( having nits and at least 3 live lice))"|3 weeks|"The Efficacy Intention to Treat (eITT) population was the primary population for demonstrating the superiority of the Malathion product to the active control Nix® Crème Rinse.
eITT population: included all index subjects with at least one application of treatment.
Proportion of Subjects that are lice-free 14 days after their last treatment"||percentage of subjects|||Number
796102|NCT00927563|Secondary|Gambling Symptom Assessment Scale (G-SAS)|Self report test of severity of gambling on a scale from 0-48 with 48 being the most severe. The G-SAS was performed at every visit (1-5), but only the final visit (visit 5) will be reported here as a final score.|Visit 5 (final visit)|||units on a scale||Standard Deviation|Mean
796103|NCT00927563|Secondary|Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling (PG-YBOCS)|Scale used to measure severity of gambling. Scores could range from 0-40 with 0 being the least severe and 40 being the most severe. Here the total score was used. The PG-YBOCS was completed at every visit (1-5), but the final visit (visit 5) will be the only score reported.|Visit 5 (final visit)|||units on a scale||Standard Deviation|Mean
796104|NCT00927563|Primary|Clinical Global Impression Scale (CGI)|The overall impression of the clinician of the severity of the subject. Scores between 1 and 7 with 1 not being ill at all and 7 being one of the worst cases seen. CGI is assessed at every visit (1-5), but only the final visit will be reported here.|Visit 5 (final visit)|||units on a scale||Standard Deviation|Mean
796105|NCT00927576|Primary|Performance in TBI Patients and Controls|Subjects were assessed on a set of cognitive tests. Here we describe the results on the simple reaction time test in which subjects respond as rapidly as possible to the computer-controlled occurrence of a visual stimulus by pressing a mouse button. Two control groups were used. One large control group underwent a single test to provide data from subjects with a broad range of age and education. The other, smaller, control group underwent three tests at weekly intervals to evaluate the test-retest reliability of the measure.|Subjects were tested in a single 2-hr session.|Data from two TBI patients were excluded due to suspected suboptimal effort.||ms||Standard Deviation|Mean
796106|NCT00927589|Primary|Minimum Observed Serum Trough Concentration (Cmin) of Trastuzumab||15 (±15) minutes prior to the start of the trastuzumab infusion on Cycle 1 Day 2, Cycle 1 Day 8, Cycle 2 Day 1, and Cycle 3 Day 1|PK analysis population for trastuzumab. n=participants with available data at each timepoint.||mcg/mL||95% Confidence Interval|Geometric Mean
796107|NCT00927589|Primary|Maximum Observed Serum Concentration (Cmax) of Trastuzumab||30 (±15) minutes after the end of the infusion on Cycle 1 Day 2, Cycle 1 Day 8, Cycle 2 Day 1, and Cycle 3 Day 1|The PK analysis population for trastuzumab included all participants who had at least 1 measurable serum trastuzumab concentration collected at a nominal sampling timepoint. Participants who did not receive a trastuzumab dose or for whom no trastuzumab PK samples were reported were excluded. n=participants with available data at each timepoint.||mcg/mL||95% Confidence Interval|Geometric Mean
796108|NCT00927589|Primary|Plasma Decay Half-Life (t1/2) of Carboplatin|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 to 5, 60 (±5), 120 (±10), 240 (±10), and 360 (±15) minutes after end of infusion on Cycle 1 Day 1 (in absence of trastuzumab) and Cycle 2 Day 1 (in presence of trastuzumab)|The PK analysis population for carboplatin. n=participants with available data at each timepoint.||hr||Standard Deviation|Mean
796109|NCT00927589|Primary|Geometric Mean Ratio of AUC0-6hr/D of Carboplatin|The geometric mean ratio of AUC0-6hr/D of carboplatin was defined as the AUC0-6hr/D of carboplatin on Cycle 1 Day 1 (in the absence of trastuzumab) divided by AUC0-6hr/D of carboplatin on Cycle 2 Day 1 (in the presence of trastuzumab).|0 to 5, 60 (±5), 120 (±10), 240 (±10), and 360 (±15) minutes after end of infusion on Cycle 1 Day 1 (in absence of trastuzumab) and Cycle 2 Day 1 (in presence of trastuzumab)|The PK analysis population for carboplatin||ratio||90% Confidence Interval|Geometric Mean
796110|NCT00927589|Primary|Dose−Normalized AUC0-6hr (AUC0-6hr/D) of Carboplatin|AUC0-6hr/D = Area under the plasma concentration versus time curve from 0 to 6 hours post-infusion, normalized by carboplatin dose level.|0 to 5, 60 (±5), 120 (±10), 240 (±10), and 360 (±15) minutes after end of infusion on Cycle 1 Day 1 (in absence of trastuzumab) and Cycle 2 Day 1 (in presence of trastuzumab)|The PK analysis population for carboplatin||(hr*mcg/mL)/(min*mg/mL)||Standard Deviation|Mean
796111|NCT00927589|Primary|Geometric Mean Ratio of Cmax/D of Carboplatin|The geometric mean ratio of Cmax of carboplatin was defined as the Cmax/D of carboplatin on Cycle 1 Day 1 (in the absence of trastuzumab) divided by Cmax/D of carboplatin on Cycle 2 Day 1 (in the presence of trastuzumab).|0 to 5 minutes after end of infusion on Cycle 1 Day 1 (in absence of trastuzumab) and Cycle 2 Day 1 (in presence of trastuzumab)|The PK analysis population for carboplatin||ratio||90% Confidence Interval|Geometric Mean
796112|NCT00927589|Secondary|Population Pharmacokinetics of Trastuzumab|As per planned analysis, separate population pharmacokinetic analysis results are not available for the current study as this analysis is based on pooled data from multiple studies.|15 (±15) minutes prior to the start of the trastuzumab infusion, and 30 (±15) minutes after the end of the infusion on Cycle 1 Day 2, Cycle 1 Day 8, Cycle 2 Day 1, and Cycle 3 Day 1||||||
796113|NCT00927589|Secondary|Number of Participants With Abnormal Changes in QRS Interval|Criteria for abnormal changes in QRS interval were defined as: >=25% change from baseline, an absolute value >110 msec, or >=25% change from baseline and an absolute value >110 msec.|Baseline, Cycle 1 Day 2 (30 minutes postdose), Cycle 1 Day 8 (15 minutes predose), Cycle 1 Day 8 (30 minutes postdose), Cycle 2 Day 1 (15 minutes predose), and Cycle 2 Day 1 (30 minutes postdose)|ECG-evaluable participant population. n=participants with available data at each timepoint.||participants|||Number
796114|NCT00927589|Secondary|Number of Participants With Abnormal Changes in PR Interval|Criteria for abnormal changes in PR interval were defined as: =>25 percentage (%) change from baseline, an absolute value >200 msec, or >=25% change from baseline and an absolute value >200 msec.|Baseline, Cycle 1 Day 2 (30 minutes postdose), Cycle 1 Day 8 (15 minutes predose), Cycle 1 Day 8 (30 minutes postdose), Cycle 2 Day 1 (15 minutes predose), and Cycle 2 Day 1 (30 minutes postdose)|ECG-evaluable participant population. n=participants with available data at each timepoint.||participants|||Number
796115|NCT00927589|Secondary|Number of Participants With New Abnormal T Waves on ECG|The incidence of abnormal T-wave changes from baseline was determined based on centrally read ECG tracings comparing each of the three triplicate readings from the post baseline ECG time points to the baseline ECG reading. At each time point, if at least one of the three triplicate readings was abnormal, the participant was counted as abnormal for that ECG timepoint as follows: an inverted T, flat T, or biphasic T compared with baseline was considered an abnormal significant change from baseline. Additionally, nonspecific T-wave changes from baseline were considered as abnormal nonsignificant changes from baseline. T-wave changes from baseline due to ventricular conduction or left ventricular hypertrophy strain were considered not evaluable.|Baseline, Cycle 1 Day 2 (30 minutes postdose), Cycle 1 Day 8 (15 minutes predose), Cycle 1 Day 8 (30 minutes postdose), Cycle 2 Day 1 (15 minutes predose), and Cycle 2 Day 1 (30 minutes postdose)|ECG-evaluable participant population. n=participants with available data at each timepoint.||participants|||Number
796116|NCT00927589|Secondary|Number of Participants With New Abnormal U Waves on ECG|The incidence of abnormal U-wave changes from baseline was determined based on centrally read ECG tracings comparing each of the three triplicate readings from the post baseline ECG time points to the baseline ECG reading. At each time point, if at least one of the three triplicate readings was abnormal, the participant was counted as abnormal for that ECG timepoint as follows: a large U wave, inverted U wave, or T-U fusion compared with baseline was considered an abnormal significant change from baseline.|Baseline, Cycle 1 Day 2 (30 minutes postdose), Cycle 1 Day 8 (15 minutes predose), Cycle 1 Day 8 (30 minutes postdose), Cycle 2 Day 1 (15 minutes predose), and Cycle 2 Day 1 (30 minutes postdose)|ECG-evaluable participant population. n=participants with available data at each timepoint.||participants|||Number
796266|NCT00928408|Primary|Occurrence of a Change in Cinacalcet Dose or Frequency >6 Months After Initiation||>6 months after initiation|Full Analysis Set - Participants with Observed Data||Participants|||Number
796117|NCT00927589|Secondary|Number of Participants With Increase From Baseline in QTc Interval|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia’s formula (QTcF = QT divided by cube root of RR) and by Bazette’s formula (QTcB = QT divided by square root of RR). Participants with maximum increase from baseline of =>30msec, 30 to <60 msec (borderline) and >=60 msec (prolonged) were summarized.|Baseline, Cycle 1 Day 2 (30 minutes postdose), Cycle 1 Day 8 (15 minutes predose), Cycle 1 Day 8 (30 minutes postdose), Cycle 2 Day 1 (15 minutes predose), and Cycle 2 Day 1 (30 minutes postdose)|ECG-evaluable participant population. n=participants with available data at each timepoint.||participants|||Number
796118|NCT00927589|Secondary|Number of Participants Within Each Absolute QTc Interval Category|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia’s formula (QTcF = QT divided by cube root of RR) and by Bazette’s formula (QTcB = QT divided by square root of RR). Participants with maximum QTc less than or equal to (<=) 450 msec, greater than (>) 450 to <=470 msec, >470 to <= 500 msec, or >500 msec were reported.|Baseline, Cycle 1 Day 2 (30 minutes postdose), Cycle 1 Day 8 (15 minutes predose), Cycle 1 Day 8 (30 minutes postdose), Cycle 2 Day 1 (15 minutes predose), and Cycle 2 Day 1 (30 minutes postdose)|ECG-evaluable participant population. n=participants with available data at each timepoint.||participants|||Number
796119|NCT00927589|Secondary|Baseline-adjusted Heart Rate|For each postbaseline timepoint, a participant’s corresponding baseline heart rate was subtracted from his or her average of the triplicate heart rate to create a “baseline-adjusted” corresponding heart rate for each participant at each postbaseline timepoint.|Baseline, Cycle 1 Day 2 (30 minutes postdose), Cycle 1 Day 8 (15 minutes predose), Cycle 1 Day 8 (30 minutes postdose), Cycle 2 Day 1 (15 minutes predose), and Cycle 2 Day 1 (30 minutes postdose)|ECG-evaluable participant population. n=participants with available data at each timepoint.||beats per minute (bpm)||Standard Deviation|Mean
796120|NCT00927589|Secondary|Baseline-adjusted QTcF, QTcB, PR Interval, and QRS Duration|For each postbaseline timepoint, a participant’s corresponding baseline measure was subtracted from his or her average of the triplicate ECG measure to create a “baseline-adjusted” corresponding ECG measure for each participant at each postbaseline timepoint.|Baseline, Cycle 1 Day 2 (30 minutes postdose), Cycle 1 Day 8 (15 minutes predose), Cycle 1 Day 8 (30 minutes postdose), Cycle 2 Day 1 (15 minutes predose), and Cycle 2 Day 1 (30 minutes postdose)|ECG-evaluable participant population. n=participants with available data at each timepoint.||msec||Standard Deviation|Mean
796121|NCT00927589|Secondary|Change From Baseline in Corrected QT Interval Using Bazett’s Correction (QTcB) at Trastuzumab Steady State|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Bazette’s formula (QTcB = QT divided by square root of RR). Trastuzumab steady state was defined as the average of the 2 ECG measurements collected on Cycle 1 Day 8 and Cycle 2 Day 1 after the trastuzumab infusion.|Baseline, Cycle 1 Day 8 and Cycle 2 Day 1|ECG-evaluable participant population||msec||90% Confidence Interval|Mean
796122|NCT00927589|Primary|Dose-Normalized Cmax (Cmax/D) of Carboplatin|Dose normalized Cmax is the maximum observed concentration of carboplatin in plasma normalized for different dose levels.|0 to 5 minutes after end of infusion on Cycle 1 Day 1 (in absence of trastuzumab) and Cycle 2 Day 1 (in presence of trastuzumab)|The PK analysis population for carboplatin||(mcg/mL)/(min*mg/mL)||Standard Deviation|Mean
796123|NCT00927589|Primary|Area Under the Curve From Time Zero to 6 Hours Post Infusion (AUC0-6hr) of Carboplatin|AUC0-6hr = Area under the plasma concentration versus time curve from 0 to 6 hours post-infusion.|0 to 5, 60 (±5), 120 (±10), 240 (±10), and 360 (±15) minutes after end of infusion on Cycle 1 Day 1 (in absence of trastuzumab) and Cycle 2 Day 1 (in presence of trastuzumab)|The PK analysis population for carboplatin||Hour*microgram/milliliter (hr*mcg/mL)||Standard Deviation|Mean
796124|NCT00927589|Primary|Maximum Observed Plasma Concentration (Cmax) of Carboplatin||0 to 5 minutes after end of infusion on Cycle 1 Day 1 (in absence of trastuzumab) and Cycle 2 Day 1 (in presence of trastuzumab)|The pharmacokinetic (PK) analysis population for carboplatin included all participants who had a measurable ultrafiltrate or plasma carboplatin concentration at all nominal sampling time points. Participants for whom a full set of carboplatin PK samples in both Cycle 1 and Cycle 2 was not reported were excluded.||Microgram per milliliter (mcg/mL)||Standard Deviation|Mean
796125|NCT00927589|Primary|Change From Baseline in Corrected QT Interval Using Fridericia’s Correction (QTcF) at Trastuzumab Steady State|Triplicate 12-lead electrocardiogram (ECG) measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia’s formula (QTcF = QT divided by cube root of RR). Trastuzumab steady state was defined as the average of the 2 ECG measurements collected on Cycle 1 Day 8 (C1D8) and Cycle 2 Day 1 (C2D1) after the trastuzumab infusion.|Baseline, Cycle 1 Day 8 and Cycle 2 Day 1|ECG-evaluable participant population: received any trastuzumab, had at least 1 interpretable baseline ECG measurement recorded on C1D2 prior trastuzumab exposure, had at least 1 interpretable ECG measurement recorded on C1D8 or C2D1 corresponding to time of steady-state trastuzumab concentration, and no infusion reaction requiring drug treatments.||milliseconds (msec)||90% Confidence Interval|Mean
796126|NCT00927758|Primary|Percentage Change From Baseline (for Each Treatment Cycle) in Exhaled Nitric Oxide (eNO)|Percentage change in eNO was reported following treatment with inhaled Advair in subjects with chronic but stable asthma as defined in Global Initiative for Asthma (GINA) guidelines. eNO was calculated 3 times every day in a treatment cycle for 7 days. The maximum value of all 3 collected value were collected for each seven days of the individual treatment cycle. Out of the maximum values, the minimum was taken and used for calculating the percentage change from baseline.|Baseline to Day 7 of each treatment cycle (total duration about 8 - 10 weeks)|The per-protocol (PP) population was all subjects who completed the study with no major variances that would impair the analysis of the data||Percentage change in eNO||Standard Deviation|Mean
796519|NCT00929734|Secondary|Relative Change in High-sensitivity C-reactive Protein||Baseline to 3 months|Complete case analysis||percent change||Inter-Quartile Range|Median
796127|NCT00927823|Secondary|Number of Participants With Objective Response|Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to response evaluation criteria in solid tumors version 1.1 (RECIST v1.1). Confirmed responses are those that persist on repeat imaging study >=4 weeks after initial documentation of response. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.|Baseline, prior to Day 1 of Cycle every odd-numbered cycle or when progressive disease was suspected|Response analysis set included all participants who started treatment and had an adequate baseline tumor assessment.||participants|||Number
796128|NCT00927823|Secondary|Number of Participants With Mutation, Deletion, Amplification in Phosphatidylinositol 3-kinase (PI3K) Pathway Signaling Related Genes and/or Proteins in Biopsied Tumor Tissue|Biopsied tumor tissue was analyzed for alterations in the phosphoinositide-3-kinase/rat sarcoma (PI3K/RAS) signaling pathway by molecular approaches. The biomarkers studied were phosphoinositide-3-kinase, catalytic, alpha (PIK3CA) gene mutation, PIK3CA gene amplification, and phosphatase and tensin homolog (PTEN) protein deficiency status by immunohistochemistry.|Baseline; 4 hours post-dose on C1D21|Baseline tumor tissue biomarker analysis set: all enrolled participants who started treatment, had baseline tumor tissues (archived paraffin block/unstained slides/fresh tumor tissue) analyzed for at least 1 of biomarkers. N (number of participants analyzed)=participants evaluable for this measure. n=participants evaluable at specified time point.||participants|||Number
796129|NCT00927823|Secondary|Change From Baseline in Hair Follicle Biopsy Biomarkers at Cycle 1 Day 21|Hair follicle biopsy samples analysis included assessment of status of proteins indicative of PI3K/mTOR related pathways signaling status and cell cycle status. The analytes measured were phosphorylated AKT S473, AKT T308, KI67, STAT3 (Y705) and proline-rich Akt substrate of 40 kilodaltons at Thr246 (PRAS40 T246). The method of analysis was reverse phase microarray (RPMA). The signal for each biomarker expressed as normalized fluorescence intensity (NFI) was normalized by their respective total protein concentration. This normalization was performed by dividing the biomarker NFI by total protein concentration (mg/mL) of the sample printed to give total protein normalized fluorescence unit (NFU). All clinical sample test results are reported in NFU.|Baseline; pre-dose, 2, 4, 24 hours post-dose on C1D21|Hair follicle analysis set included participants with hair follicles collected and analyzed for biomarkers at screening and on treatment. n=participants evaluable at specified time point. Only PF-04691502 8 mg treatment arm was evaluable for this outcome.||NFU||Standard Deviation|Mean
796130|NCT00927823|Secondary|Change From Baseline in Fresh Tumor Biopsy Biomarkers at Cycle 1 Day 21|Fresh tumor biopsy samples analysis included assessment of status of proteins indicative of phosphoinositide 3-kinase/mammalian target of rapamycin (PI3K/mTOR) related pathways signaling status and cell cycle status. The biomarkers included phosphorylated activated kinase (AKT) S473, AKT T308, signal transducer and activator of transcription 3 (STAT3) and forkhead transcription factor Foxo1 (FKHR) T24/forkhead in rhabdomysacoma-like 1 (FKHRL1) T32. The method of analysis was reverse phase microarray (RPMA). The signal (normalized fluorescence unit [NFU]) for each pathway biomarker was normalized against the signal (NFU) for cytokeratin. The final concentration for each pathway biomarker was reported as a cytokeratin normalized fluorescence unit (NFC) value.|Baseline; 4 hours post-dose on C1D21|Fresh tumor biopsy analysis set included all enrolled participants in the tumor biopsy cohort who started treatment and had baseline and on-treatment fresh tumor tissue successfully analyzed for at least 1 of the biomarkers. n=participants evaluable at specified time point. Only PF-04691502 8 mg treatment arm was evaluable for this outcome.||NFC||Standard Deviation|Mean
796131|NCT00927823|Secondary|Change From Baseline in Serum C-peptide at Cycle 1 Day 8 (C1D8), C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and End of Treatment (EOT)|Serum C-peptide level was measured following 4 hours fasting. EOT data included values from participants who came off-treatment before cycle 8.|Baseline, C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and EOT|Serum biomarker analysis set. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable at specified time point for each arm, respectively. Results of PF-04691502 2 mg and 4 mg arm not reported because none of the participants were evaluable.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
796132|NCT00927823|Secondary|Change From Baseline in Serum Insulin at Cycle 1 Day 8 (C1D8), C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and End of Treatment (EOT)|Serum insulin level was measured following 4 hours fasting. EOT data included values from participants who came off-treatment before cycle 8.|Baseline, C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and EOT|Serum biomarker analysis set. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable at specified time point for each arm, respectively.||micro International Unit/mL (mc IU/mL)||Standard Deviation|Mean
796133|NCT00927823|Secondary|Change From Baseline in Serum Glucose at Cycle 1 Day 8 (C1D8), C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and End of Treatment (EOT)|Serum glucose level was measured following 4 hours fasting. EOT data included values from participants who came off-treatment before cycle 8.|Baseline, C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and EOT|Serum biomarker analysis set included all enrolled participants who started treatment and had baseline and on-treatment serum biomarker samples (insulin, glucose, and c-peptide) successfully analyzed for at least 1 of the biomarkers. n=participants evaluable at specified time point for each arm, respectively.||milligram per deciliter (mg/dL)||Standard Deviation|Mean
796144|NCT00927823|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to 28 days after the last dose|Safety analysis set included all enrolled participants who started the treatment.||participants|||Number
796134|NCT00927823|Secondary|Number of Participants With Maximum Post-dose QT Interval Corrected Using Fridericia's Formula (QTcF)|Triplicate 12-lead electrocardiogram (ECG) measurements (each recording separated by approximately 2-4 minutes) were performed and average calculated. QT interval is the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTcF is the QT interval corrected for heart rate. Corrected QT interval using Fridericia's heart rate correction formula: QTcF = QT/RR^1/3, where RR=RR interval in seconds. End of treatment (EOT) data included values from participants who came off-treatment before cycle 8.|Pre-dose, 30 minutes, 1, 2, 4, 8, 24, 48, hrs post-dose in Lead-in period; 1 hour post-dose on C1D8, C1D15; 1, 2, 4, 8 hours post-dose on C1D21; 1 hour post-dose C2D1, C2D15, D1 of subsequent cycles up to C8; EOT|QTc analysis set included all enrolled participants had at least 1 ECG assessment after receiving PF-04691502.||participants|||Number
796135|NCT00927823|Secondary|Number of Participants With Increase From Baseline in QT Interval Corrected Using Fridericia's Formula (QTcF)|Triplicate 12-lead electrocardiogram (ECG) measurements (each recording separated by approximately 2-4 minutes) were performed and average calculated. QT interval is the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTcF is the QT interval corrected for heart rate. Corrected QT interval using Fridericia's heart rate correction formula: QTcF = QT/RR^1/3, where RR=RR interval in seconds. End of treatment (EOT) data included values from participants who came off-treatment before cycle 8.|Pre-dose, 30 minutes, 1, 2, 4, 8, 24, 48, hrs post-dose in Lead-in period; 1 hour post-dose on C1D8, C1D15; 1, 2, 4, 8 hours post-dose on C1D21; 1 hour post-dose C2D1, C2D15, D1 of subsequent cycles up to C8; EOT|QTc analysis set included all enrolled participants who had at least 1 ECG assessment after receiving PF-04691502.||participants|||Number
796136|NCT00927823|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)|AUCtau is the area under the plasma concentration time-curve from time zero to end of dosing interval (tau), where tau is the dosing interval of 24 hours. It was evaluated following repeated oral dose administration for 21 days in Cycle 1 (multiple dose PK) only.|Pre-dose, 30 minutes, 1, 2, 4, 6, 8, 24 hrs post-dose on C1D21|PK population included all randomized participants who received treatment and had at least 1 of the PK parameters of interest estimated. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
796137|NCT00927823|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]|AUC (0-∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞). It was evaluated following a single oral dose in lead-in-dose period (single dose PK) only.|Pre-dose, 30 minutes, 1, 2, 4, 6, 8, 24, 48, 72, 96 hours post-dose in Lead-in period|PK population included all randomized participants who received treatment and had at least 1 of the PK parameters of interest estimated.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
796138|NCT00927823|Secondary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Plasma decay half-life of PF-04691502 was assessed following a single oral dose administration in lead-in-dose period (single dose PK) and repeat oral dose administration for 21 days in Cycle 1 (multiple dose PK).|Pre-dose, 30 minutes, 1, 2, 4, 6, 8, 24, 48, 72, 96 hours (hrs) post-dose in Lead-in period; pre-dose, 30 minutes, 1, 2, 4, 6, 8, 24 hrs post-dose on C1D21|PK population included all randomized participants who received treatment and had at least 1 of the PK parameters of interest estimated. n=participants evaluable at specified time point for each arm, respectively.||hours||Standard Deviation|Mean
796139|NCT00927823|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). It was evaluated following a single oral dose in lead-in-dose period (single dose PK) only.|Pre-dose, 30 minutes, 1, 2, 4, 6, 8, 24, 48, 72, 96 hours post-dose in Lead-in period|PK population included all randomized participants who received treatment and had at least 1 of the PK parameters of interest estimated.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
796140|NCT00927823|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)|The PK of PF-04691502 was assessed following a single oral dose administration in lead-in-dose period (single dose PK) and repeated oral dose administration for 21 days in Cycle 1 (multiple dose PK).|Pre-dose, 30 minutes, 1, 2, 4, 6, 8, 24, 48, 72, 96 hours post-dose in Lead-in period; pre-dose, 30 minutes, 1, 2, 4, 6, 8, 24 hours post-dose on C1D21|PK population included all randomized participants who received treatment and had at least 1 of the PK parameters of interest estimated. n=participants evaluable at specified time point for each arm, respectively.||hours||Full Range|Median
796141|NCT00927823|Secondary|Maximum Observed Plasma Concentration (Cmax)|The pharmacokinetics (PK) of PF-04691502 was assessed following a single oral dose administration in lead-in-dose period (single dose PK) and repeated oral dose administration for 21 days in Cycle 1 (multiple dose PK).|Pre-dose, 30 minutes, 1, 2, 4, 6, 8, 24, 48, 72, 96 hours post-dose in Lead-in period; pre-dose, 30 minutes, 1, 2, 4, 6, 8, 24 hours post-dose on Cycle 1 Day 21 (C1D21)|PK population included all randomized participants who received treatment and had at least 1 of the PK parameters of interest estimated. n=participants evaluable at specified time point for each arm, respectively.||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
796142|NCT00927823|Primary|Recommended Phase-2 Dose (RP2D)|RP2D was determined based on the safety profile and pharmacodynamic findings, as per investigator's discretion.|Baseline up to Cycle 1 Day 21|Safety analysis set included all enrolled participants who started the treatment.||milligram|||Number
796143|NCT00927823|Primary|Number of Participants With Dose Limiting Toxicities (DLTs)|DLT was classified as per common terminology criteria for adverse events (CTCAE) version 4.0 and defined as any of the following events occurring after first dose of study medication and considered at least possibly-related to study medication. Hematological: grade 4 neutropenia (absolute neutrophil count [ANC] <500 cells per cubic millimeter [cells/mm^3]) for 1 week or greater, febrile neutropenia (fever >=38.5 degree celsius with ANC <1000/mm^3), grade 3 (50,000 cells/mm^3) and grade 4 (<25,000 cells/mm^3) thrombocytopenia; Non-Hematologic: grade 3 or 4 nausea, vomiting, or diarrhea and any clinically significant grade 3 or greater non-hematologic toxicity, despite the use of adequate/maximal medical intervention and/or prophylaxis, and any persistent, intolerable PF-04691502 related toxicity which delayed retreatment for >14 days.|Baseline up to Cycle 1 Day 21|Safety analysis set included all enrolled participants who started the treatment.||participants|||Number
827558|NCT01208220|Secondary|Removal of Harmful Fluids in the Wound Tissue||2 weeks into study|||percentage of cytotoxins removed|||Number
796148|NCT00927862|Primary|The Time in Therapeutic Range (TTR) for the Pharmacogenetic-guided Patients and Parallel Controls|The percent of time in therapeutic INR range for the pharmacogenetic (PG)-dosing (standard + modified IWPC warfarin algorithms) guided patients and parallel controls. To account for laboratory INR-measurement error, a 10% margin inside of the target range was allowed in determine TTR values, ie, INRs 1.8-3.3 for INR 2.5 target; 2.25-3.85 for INR 3.0 target. What is reported is the percent of TTR for each patient during 1 month.|1 month (from baseline to day 30)|Patients who were enrolled in CoumaGen-II and thus, received their warfarin dosing by the PG-dosing algorithms (standard or modified IWPC warfarin algorithms) were compared to parallel controls.||percent||95% Confidence Interval|Mean
796149|NCT00927862|Primary|The Percent of Time in Therapeutic Range (TTR) for the Standard and Modified Pharmacogenetic Algorithms.|The percent of time in therapeutic INR range for the standard and modified pharmacogenetic algorithms at 1 month. To account for laboratory INR-measurement error, a 10% margin inside of the target range was allowed in determine TTR values, ie, INRs 1.8-3.3 for INR 2.5 target; 2.25-3.85 for INR 3.0 target. What is reported is the percent of TTR for each patient during 1 month.|1 month (from baseline to day 30)|Patients >= 18 years of age who have an indication for initiation of warfarin anticoagulation, gave written informed consent, and met other inclusion/exclusion criteria were studied.||percent||95% Confidence Interval|Mean
796150|NCT00927862|Primary|The Percent of Out of Range (OOR) INRs in Pharmacogenetic-guided Patients and Parallel Controls|The percent of out of range (OOR) INRs in the pharmacogenetic (PG)-dosing (standard + modified IWPC warfarin algorithms) and parallel controls. A 10% margin outside of the target INR range was allowed in determination of OOR values, ie, INRs <1.8, >3.3 for INR 2.5 target; <2.25, >3.85 for INR 3.0 target. What is reported is the percent of patients with OOR INRs at 1 month.|1 month (from day 3 to day 30)|Patients who were enrolled in CoumaGen-II and thus, received their warfarin dosing by the PG-dosing algorithms (standard or modified IWPC warfarin algorithms) were compared to parallel controls||percent||95% Confidence Interval|Mean
796151|NCT00927862|Secondary|Prediction of a Stable Maintenance Dose Among the Pharmacogenetic (PG)-Guided Dosing Algorithms and the Parallel Controls|Prediction of a stable maintenance dose (within 1 mg/day) among the pharmacogenetic (PG)-guided dosing and the parallel control group. For the parallel control group, an empiric starting dose of 5 mg/day was assumed. What is reported is the percent of patients who had their maintenance dose predicted as described above.|3 months (from baseline to 3 months or until stable dosing is achieved, whichever occurs first)|Patients who were enrolled in CoumaGen-II and thus, received their warfarin dosing by the PG-dosing algorithms (standard or modified IWPC warfarin algorithms) and had a stable maintenance dose that could be determined were compared to parallel controls||percent|||Number
796152|NCT00927862|Secondary|The Number of INRs Measured up to 3 Months in the Pharmacogenetic (PG) (Modified and Standard) Algorithms and Parallel Controls.|What is reported is the mean number of INRs measured/drawn among the patients in each arm.|1-3 months (from baseline to 3 months or end of warfarin therapy, whichever occurs first)|Patients who were enrolled in CoumaGen-II and thus, received their warfarin dosing by the PG-dosing algorithms (standard or modified IWPC warfarin algorithms) were compared to parallel controls||INRs||Standard Deviation|Mean
796153|NCT00927862|Secondary|The Percent of INRs ≥4 or ≤1.5 or SAEs Among the Modified IWPC Warfarin Algorithm and Standard IWPC Warfarin Algorithm.|What is reported is the percent of patients with INRs ≥4 or ≤1.5 or having experienced a serious adverse event (SAE) at the end of follow-up.|3 months (from baseline to 3 months or end of warfarin therapy, whichever occurs first)|All patients receiving at least 1 dose of warfarin were included in safety analyses until 1 week after the last warfarin dose||percent|||Number
796154|NCT00927862|Secondary|The Percent of INRs ≥4 or ≤1.5 for the Modified IWPC Warfarin Algorithm and the Standard IWPC Warfarin Algorithm|The percent of INRs ≥4 or ≤1.5 for the pharmacogenetic (modified IWPC warfarin algorithm and the standard IWPC warfarin) algorithms. What is reported is the percent of patients with INRs ≥4 or ≤1.5 at the end of follow-up.|3 months (baseline to 3 months or to end of warfarin therapy, whichever occurs first)|All consented, randomized patients who were successfully genotyped and received at least 1 dose of warfarin with at least 1 postdose INR.||percent||Standard Deviation|Mean
796155|NCT00927862|Primary|The Percent of Out of Range (OOR) International Normalized Prothrombin Time Ratio (INRs) in the Standard and Modified Pharmacogenetic Arms.|The percent of out of range (OOR) international normalized prothrombin time ratio (INRs) in the standard and modified pharmacogentic algorithms at 1 month. To account for laboratory INR-measurement error, a 10% margin outside of the target range was allowed in determination of OOR values, ie, INRs <1.8, >3.3 for INR 2.5 target; <2.25, >3.85 for INR 3.0 target. What is reported is the percent of patients with an OOR INR at 1 month.|1 month (from day 3 to day 30)|Patients >= 18 years of age who have an indication for initiation of warfarin anticoagulation, gave written informed consent, and met other inclusion/exclusion criteria were studied.||percent||95% Confidence Interval|Mean
796156|NCT00927888|Secondary|SNOT-20 Surgical Outcome Score|"This measures uses a 20 item surgical assessment tool to assess surgical field. This assessment score is the Sino-Nasal Outcome Test, SNOT-20. Patients were completed this validated sinus symptom questionnaire. The average magnitude score for the 20 items is calculated. Each item of the 20-question assessment is scored from 1 to 5 where 1 is less severe and 5 is a maximum as described by that particular symptom score. The final score is reported as a mean with a range of 0 (zero) to 5 (no units).
ref. Otolaryngol Head Neck Surg, 126 (2002), pp. 41–47"|1-day|Entire study population included.||units on a scale|Participants|Standard Deviation|Mean
796157|NCT00927888|Primary|Postoperative Pain Assessed on Standard VAS Scale|Post-operative quality of recovery and pain followed up to 1 month. Visual Analog Pain (VAS) was recorded by the patient on a 10-centimeter line to mark an estimated pain score that could be from zero (0) to ten (10). Zero would indicate no pain while a score of 10 would be the worse pain possible.|VAS Pain Score at 7 days|Entire population of both groups.||units on a scale|Participants|Standard Deviation|Mean
796158|NCT00927901|Secondary|Indacaterol Exposure (Cmax) at the End of Each 7 Day Treatment Period|Venous blood samples for pharmacokinetic evaluation were collected at 15 and 30 minutes; and 1, 2, 4, 12, and 24 hours post-dose at the end of each 7 day treatment period and were analyzed using a LC-MS/MS assay. Maximum (peak) plasma drug concentration after drug administration (Cmax) was calculated from concentration-time data and recorded sampling times using non-compartmental methods.|End of each treatment period (Day 7)|Pharmacokinetic analysis set: All subjects with evaluable pharmacokinetic parameter data. Number of subjects varied due to missing values.||pg/mL||Geometric Coefficient of Variation|Geometric Mean
796159|NCT00927901|Secondary|Indacaterol Exposure (AUC[0-24 Hours]) at the End of Each 7 Day Treatment Period|Venous blood samples for pharmacokinetic evaluation were collected at 15 and 30 minutes; and 1, 2, 4, 12, and 24 hours post-dose at the end of each 7 day treatment period and were analyzed using a LC-MS/MS assay. Area under the concentration-time curve up to 24 hours (AUC[0-24 hours]) was calculated from concentration-time data and recorded sampling times using non-compartmental methods.|End of each treatment period (Day 7)|Pharmacokinetic analysis set: All subjects with evaluable pharmacokinetic parameter data. Number of subjects varied due to missing values.||pg * hr/mL||Geometric Coefficient of Variation|Geometric Mean
796160|NCT00927901|Secondary|Percentage of Patients Using Rescue Medication During Each 7 Day Treatment Period|Patients recorded use of rescue medication (salbutamol/albuterol multi-dose inhaler) as the number of puffs taken in respective preceding 12 hours morning and evening in a diary. Patient with any use of rescue medication (any number of puffs > 0) was included to calculate endpoint.|Baseline to the end of each treatment period (Day 7)|Efficacy analysis set: All randomized subjects that received at least 1 dose of study drug and had a baseline and at least 1 post-baseline measurement of FEV1.||Percentage of participants|||Number
796161|NCT00927901|Secondary|Time to Peak Forced Expiratory Volume in 1 Second (FEV1) on Day 1 and Day 7|FEV1 was measured with spirometry conducted according to internationally accepted standards at 5, 15, and 30 minutes; 1 hour, 1 hour 30 minutes; and 2, 4, and 12 hours post-dose on Day 1 and Day 7.|Day 1 and Day 7|Efficacy analysis set: All randomized subjects that received at least 1 dose of study drug and had a baseline and at least 1 post-baseline measurement of FEV1.||Hours||90% Confidence Interval|Median
796162|NCT00927901|Secondary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose on Day 1|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at Baseline and on Day 1. The analysis included period baseline FEV1 as covariate.|Baseline to Day 1|Efficacy analysis set: All randomized subjects that received at least 1 dose of study drug and had a baseline and at least 1 post-baseline measurement of FEV1.||Liters||90% Confidence Interval|Least Squares Mean
796163|NCT00927901|Primary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Each Treatment Period (Day 7)|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at Baseline and at the end of each treatment period. The analysis included period baseline FEV1 as covariate.|Baseline to the end of each treatment period (Day 7)|Efficacy analysis set: All randomized subjects that received at least 1 dose of study drug and had a baseline and at least 1 post-baseline measurement of FEV1.||Liters||90% Confidence Interval|Least Squares Mean
796164|NCT00927927|Secondary|Area Under the Concentration-time Curve (AUC)|Systemic exposure to NNC0142-0002.|Data were collected from 0 hours to at least Day 43 (SD cohorts) and Day 85 (MD cohorts), and until the receptor occupancy was confirmed below the cut-off level for receptor positivity.|All randomised subjects exposed to at least one dose of NNC0142-0002 or placebo. Serum drug concentrations after dosing with less than 0.175 mg/kg (SD cohorts) and 0.3 mg/kg (MD cohorts) were below the lower limit of quantification.||microgram×h/mL||Geometric Coefficient of Variation|Geometric Mean
796165|NCT00927927|Primary|Frequency of Adverse Events|Adverse event: any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have a causal relationship with this treatment. Serious AE: AE that at any dose level resulted in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, a congenital anomaly or birth defect, or an important medical event that may jeopardize the subject and require medical or surgical intervention.|Adverse events were collected for a mean (min; max) of 15.7 (6.4; 42.6) weeks for single-dose subjects, and 30.6 (12.7; 43.1) for multiple-dose subjects. Visits were scheduled until receptor occupancy was below the cut-off level for receptor positivity.|All randomised subjects exposed to at least one dose of NNC0142-0002 or placebo.||events|||Number
796166|NCT00927940|Secondary|Rates of Incomplete Stent Apposition, Neointimal Hyperplastic Volume and Percent Volume Obstruction (%VO)||8 months||||||
796167|NCT00927940|Secondary|Success(Device, Lesion, Procedure), Major Adverse Cardiac Events (MACE), Target Vessel Failure (TVF), and Stent Thrombosis||12 months||||||
796168|NCT00927940|Secondary|Percent of Patient With Target Lesion Failure(Major Secondary Endpoint)|Major Secondary Endpoint Target lesion fature (TLF) is defined as cardiac death, target vessel myocardial infarction(Q wave and non-Q wave), or clinically-driven target lesion revascularization (TLR) by percutaneous or surgical methods.|12 months|ITT population||percentage of participants with TLF|||Number
796169|NCT00927940|Primary|In-stent Late Lumen Loss (LLL)|The difference between the post-procedure immediate minimal lumen diameter (MLD) and follow up angigraphy MLD|Post procedure, 8 Months|Actually a patient was excluded from this analysis because of death before 30 days follow up.||mm||Standard Deviation|Mean
796170|NCT00927953|Secondary|Time to a >= 1 Point Reduction in the Modified Rankin Scale Score||Study Day 2, 7, 14, 28, and 120|Intention to treat (ITT)||Days||95% Confidence Interval|Median
796171|NCT00927953|Secondary|Mean Modified Rankin Scale Scores|"The MRS is a 7-point disability scale that assesses the degree of disability in subjects with neurological impairment. Possible scores range from 0 (perfect health) up to 5 (severe disability). The scale is as follows:
0 = No symptoms at all
1 = No significant disability despite symptoms;
2 = Slight disability;
3 = Moderate disability;
4 = Moderately severe disability;
5 = Severe disability; bedridden, incontinent and requiring constant nursing care and attention;
6 = Dead."|Study Day 0, 2, 7, 14, 28, and 120|||units on a scale||Standard Deviation|Mean
796172|NCT00927953|Secondary|The Number of Participants With a Favorable Neurologic Outcome|"Favorable neurologic outcome responders are defined as subjects whose Modified Rankin Score is <=2. The MRS is a 7-point disability scale that assesses the degree of disability in subjects with neurological impairment. Possible scores range from 0 (perfect health) up to 5 (severe disability). The scale is as follows:
0 = No symptoms at all
1 = No significant disability despite symptoms;
2 = Slight disability;
3 = Moderate disability;
4 = Moderately severe disability;
5 = Severe disability; bedridden, incontinent and requiring constant nursing care and attention;
6 = Dead."|Study Day 2, 7, 14, 28, and 120|||participants|||Number
796520|NCT00929734|Secondary|Relative Change in FEV1||Baseline to 3 months|Complete case analysis||percent change||95% Confidence Interval|Mean
796174|NCT00927953|Primary|The Number of West Nile Neuroinvasive Disease (WNND) Participants Who Show Improvement in the Modified Rankin Scale (MRS) (>=1 Improvement in Score)|"The MRS is a 7-point disability scale that assesses the degree of disability in subjects with neurological impairment. Possible scores range from 0 (perfect health) up to 5 (severe disability). The scale is as follows:
0 = No symptoms at all
1 = No significant disability despite symptoms;
2 = Slight disability;
3 = Moderate disability;
4 = Moderately severe disability;
5 = Severe disability; bedridden, incontinent and requiring constant nursing care and attention;
6 = Dead"|Study Day 2, 7, 14, 28, and 120|All randomized participants with confirmed West Nile virus infection||participants|||Number
796175|NCT00927992|Secondary|Number of Participants With and Without Hemophilia Requiring Immunosuppressive Therapy, Had Acute Rejection, Hepatitis C Viral Infection Recurrence and Who Survived After Liver Transplantation||Post liver transplantation up to Month 3|Data was not analyzed as only hemophiliac participants were enrolled in the study.|||||
796176|NCT00927992|Secondary|Dose of Exogenous Clotting Factors Used During Liver Transplantation|Exogenous clotting factors administered post liver transplant included Prothromplex; platelets, fibrinogen and fresh frozen plasma (FFP) combination; FFP and platelets combination. Clotting factors were administered either as bolus or as continuous infusion.|Up to Day 5 post liver transplantation|Evaluable population included all the participants who met the eligibility criteria.||International Unit/kilogram (IU/kg)||Standard Deviation|Mean
796177|NCT00927992|Secondary|Number of Participants Requiring Exogenous Clotting Factor Infusion During Liver Transplantation|Exogenous clotting factors administered post liver transplant included Prothromplex; platelets, fibrinogen and fresh frozen plasma (FFP) combination; FFP and platelets combination. Clotting factors were administered either as bolus or as continuous infusion.|Up to Day 5 post liver transplantation|Evaluable population included all the participants who met the eligibility criteria.||Participants|||Number
796178|NCT00927992|Primary|Number of Participants Who Survived After Liver Transplantation|Number of participants who survived after liver transplantation was reported. The death reported was a result of acute-related transplantation complications and end-stage liver disease.|Post liver transplantation up to Month 3|Evaluable population included all the participants who met the eligibility criteria.||Participants|||Number
796179|NCT00927992|Primary|Number of Participants With Hepatitis C Viral Infection Recurrence After Liver Transplantation|Number of participants who had liver transplantation after cirrhosis due to hepatitis C virus (HCV) infection and experienced recurrence of HCV infection post liver transplantation.|Post liver transplantation up to Month 3|Evaluable population included all the participants who met the eligibility criteria.||Participants|||Number
796180|NCT00927992|Primary|Number of Participants With Acute Rejection of Liver Transplant|Any acute rejection of the liver transplant was clinically suspected and biopsy proven by central pathologist.|Post liver transplantation up to Month 3|Evaluable population included all the participants who met the eligibility criteria.||Participants|||Number
796181|NCT00927992|Primary|Number of Participants Requiring Immunosuppressive Therapy After Liver Transplantation|Cyclosporine, corticosteroids, tacrolimus, mycophenolate mofetil, everolimus were considered as immunosuppressive therapy after liver transplantation.|Post liver transplantation up to Month 3|Evaluable population included all the participants who met the eligibility criteria.||Participants|||Number
796182|NCT00928018|Secondary|To Compare the 2-year of Overall Survival, Progression-free Survival, Cumulative Incidences of Progression and Non-relapse Mortality Between the Treatment Arms for Each Histology Studied.||2 years|Given the small number of patients within each group, we considered indolent histologies (indolent B-cell NHL, CLL and HL) together in one group (indolent group), and aggressive histologies (aggressive B-cell NHL, MCL, and T-cell NHL) in another (aggressive group).||percentage of participants|||Number
796183|NCT00928018|Secondary|To Compare the 2-year Cumulative Incidence of Chronic GVHD Between the Two Treatment Arms.||2 years|||percentage of participants|||Number
796184|NCT00928018|Secondary|To Compare the 180-day Cumulative Incidence of Grades II-IV and Grades III-IV Acute GVHD Between the Two Treatment Arms||6 months|||percentage of participants|||Number
796185|NCT00928018|Secondary|To Compare the 2-year Cumulative Incidences of Disease Progression and of Non-relapse Mortality Between the Two Treatment Arms||2 years|||percentage of participants||95% Confidence Interval|Number
796186|NCT00928018|Secondary|To Compare 2-year Progression-free Survival Between the Two Treatment Arms||2 years|||percentage of participants||95% Confidence Interval|Number
796187|NCT00928018|Primary|To Compare 2-year Overall Survival of Patients With Lymphoma Undergoing RIC SCT Between Those Receiving Tacrolimus/Sirolimus/Methotrexate and Those Receiving Tacrolimus/Methotrexate or Cyclosporine/Mycophenolate Mofetil||2 years|||percentage of participants||95% Confidence Interval|Number
796188|NCT00928057|Other Pre-specified|Reported Injection Site Leakage Events, by Pen Needle Type and Droplet Size|If insulin leakage from the injection site was observed, subjects rated the size of the leakage droplet based on a visual scale provided in their diaries. Scores of 1+, 2+, 3+, and 4+ correspond to droplet sizes of 1, 10, 20 and 50 ul, respectively. Droplets larger than those shown on the scale were scored as 5+. Subjects were not required to make a diary entry if there was no leakage.|each PN was used for 3 weeks|The number of participants shown is the number of subjects that reported at least one event of leakage (see previous data table). The number of reported leakage events is presented for each droplet size category. No data were collected if there was no leakage.||number of events|||Number
796189|NCT00928057|Secondary|Relative Injection Pain Score Assessed by Subject|After using the second assigned pen needle (PN) for 3 weeks, subjects used a 150mm Visual Analog Scale (VAS) to rate the pain of the second PN relative to the first PN. The VAS was anchored at the center (0mm) with “as painful”, and at the extreme ends with “much less painful” (-75mm) and “much more painful” (+75mm). VAS scores were adjusted for the order of PN use, such that a positive score means that the 4mm PN was scored as more painful than the reference PN (5mm or 8mm), and a negative score indicates that the 4mm PN was less painful than the reference.|Visit 4: 18-24 days after starting 2nd pen needle|Of the 167 subjects that completed the study, 137 subjects had within-window VAS pain scores for Visit 4 and were included in this analysis. Per the protocol, the allowable visit window was 18-24 days from Visit 3, when the subject switched from the 1st to 2nd assigned pen needle.||mm||Standard Error|Mean
796267|NCT00928408|Primary|Occurrence of a Change in Cinacalcet Dose or Frequency >3 to 6 Months After Initiation||>3 to 6 months after initiation|Full Analysis Set - Participants with Observed Data||Participants|||Number
796191|NCT00928057|Secondary|Number of Subjects With Severe Unexplained Hyperglycemic Events|Severe Unexplained Hyperglycemia is defined as requiring a visit to the emergency room or hospitalization and/or having a blood glucose value above 450mg/dL without an identified cause (for example, the subject missed an insulin dose). These events were also reported as Adverse Events.|During 3 weeks using each pen needle|All subjects that were randomized and used at least one of the study pen needles are included. The number of subjects with one or more events while using each PN is presented.||participants|||Number
796192|NCT00928057|Secondary|Number of Subjects With Severe Unexplained Hypoglycemic Events|Severe Unexplained Hypoglycemia is defined as an event in which the subject’s blood glucose is below 50 milligrams per deciliter (mg/dL) and/or they required assistance from another person for treatment and there is no identified cause (for example, the subject skipped a meal). These events were also reported as Adverse Events.|During 3 weeks using each pen needle|All subjects that were randomized and used at least one of the study pen needles are included. The number of subjects with one or more events while using each PN is presented.||participants|||Number
796193|NCT00928057|Secondary|Percent Absolute Change in Fructosamine, by Dose Group|"Glycemic control was determined separately for each insulin dose group in the same manner as described for the primary outcome measure, according to the following formula:
%|∆ FRU|= 100*[FRU(4mm)-FRU(5 or 8mm)]/[FRU(5 or 8mm)]."|3 weeks per pen needle, from visit 2-3 and visit 3-4.|"4 of the 167 completed subjects were excluded for out of window fructosamine samples (3), or lab error with a sample (1).
For 4 mm/8 mm: this includes 45 subjects in the Low Dose insulin group and 35 in the Regular Dose group. For 4 mm/5 mm: this includes 47 subjects in the Low Dose insulin group and 36 in the Regular Dose group."||Percent absolute change||95% Confidence Interval|Mean
796194|NCT00928057|Primary|Percent (%) Absolute Change in Fructosamine|"Within each study arm (4mm / 5mm PN, or 4mm / 8mm PN) subjects used one pen needle (PN) for 3 weeks then switched to the alternate PN for the next three weeks, for a total of 6 weeks. The principal endpoint measure of glycemic control is the percent absolute change in serum fructosamine concentration, based on the fructosamine (FRU) concentration measured in micromoles per liter (umol/L) at the end of each three week period. The change was calculated according to the following formula:
Percent absolute change in FRU, or %|∆ FRU|= 100*[FRU(4mm)-FRU(5 or 8mm)]/[FRU(5 or 8mm)]."|3 weeks per pen needle, from visit 2-3 and visit 3-4.|167 subjects completed the study. 163 of the 167 completed subjects were included in this analysis. Four (4) of 167 were excluded due to out of window fructosamine samples (3), or laboratory error with fructosamine sample (1).||Percent absolute change||95% Confidence Interval|Mean
796195|NCT00928070|Secondary|Change From Baseline in Post Void Residual (PVR) Volume at Week 4 and 12|PVR volume is defined as volume of urine remaining in the bladder immediately after urination.|Baseline, Week 4, 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had non-missing change from baseline value at Week 12.||mL||Standard Deviation|Mean
796196|NCT00928070|Secondary|Change From Screening in Mini Mental State Examination (MMSE) Score at Week 12|MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranges from 0 to 30, higher score indicates better cognitive state. Change: mean score at Week X minus mean score at baseline|Screening, Week 12|FAS population included all participants who received at least 1 dose of study drug and had at least 1 baseline or post-baseline efficacy assessment. Here, 'N' (number of participants analyzed) signifies those participants who had non-missing change from baseline value at Week 12.||units on a scale||Standard Error|Least Squares Mean
796197|NCT00928070|Secondary|Mini Mental State Examination (MMSE)|MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranges from 0 to 30, higher score indicates better cognitive state.|Screening|FAS population included all participants who received at least 1 dose of study drug and had at least 1 baseline or post-baseline efficacy assessment. Here, 'N' (number of participants analyzed) signifies those participants who had non-missing change from baseline value at Week 12.||units on a scale||Standard Deviation|Mean
796198|NCT00928070|Secondary|Percentage of Participants With Overactive Bladder Satisfaction Questionnaire (OAB-S) Global Medication Satisfaction Question Response|"Participant's response to question, overall, how satisfied are you with your OAB medication? was obtained on a 5 point scale, 1- very satisfied, 2- somewhat satisfied, 3- neither dissatisfied nor satisfied, 4- somewhat dissatisfied and 5- very dissatisfied. Response values 1 and 2 were combined into satisfied, and 4 and 5 were combined into dissatisfied."|Week 12|FAS population included all participants who received at least 1 dose of study drug and had at least 1 baseline or post-baseline efficacy assessment. Here, 'N' (number of participants analyzed) signifies those participants who had non-missing value at Week 12.||percentage of participants|||Number
796199|NCT00928070|Secondary|Overactive Bladder Satisfaction Questionnaire (OAB-S) Total Score on Satisfaction With OAB Control|OAB-S: a validated self-administered instrument that evaluates OAB medication expectations, daily life with AB, and satisfaction with OAB medication and includes 3 stand-alone items that assess overall expectation, satisfaction, and willingness to continue treatment. Satisfaction coded on scale of 1 to 5: (1=very satisfied to 5=very dissatisfied). Coding reversed algorithmically and results transformed: total score range 0 to100. Higher final response value associated with better satisfaction.|Week 12|FAS population included all participants who received at least 1 dose of study drug and had at least 1 baseline or post-baseline efficacy assessment. Here, 'N' (number of participants analyzed) signifies those participants who had non-missing value at Week 12.||units on a scale||Standard Deviation|Mean
796208|NCT00928070|Secondary|Percent Change From Baseline in Nocturnal Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12|Percent change of nocturnal micturition-related urgency episodes per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (i.e., 100*(Week 4 or 12 - baseline)/baseline).|Baseline, Week 4, 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline nocturnal urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||percent change||Standard Deviation|Mean
796268|NCT00928408|Primary|Occurrence of a Change in Cinacalcet Dose or Frequency During the First 3 Months After Initiation||Initiation to Month 3|Full Analysis Set||Participants|||Number
836630|NCT01289847|Secondary|Therapeutic Efficacy|Number of days in hospital|12 months|||days||Standard Deviation|Mean
796200|NCT00928070|Secondary|Change From Baseline in Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 4 and 12|OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.|Baseline, Week 4, 12|FAS population included all participants who received at least 1 dose of study drug and had at least 1 baseline or post-baseline efficacy assessment. LOCF method was used to impute Week 12 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had non-missing change from baseline value at both Week 4 and 12.||units on a scale||Standard Error|Least Squares Mean
796201|NCT00928070|Secondary|Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q)|OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.|Baseline|FAS population included all participants who received at least 1 dose of study drug and had at least 1 baseline or post-baseline efficacy assessment. Here, 'N' (number of participants analyzed) signifies those participants who had non-missing change from baseline value at both Week 4 and 12.||units on a scale||Standard Deviation|Mean
796202|NCT00928070|Secondary|Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 4 and 12|OAB-q: a self-administered, 33-item, questionnaire that assesses how much the participant has been bothered by selected bladder symptoms. Each item rated by participant on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score – lowest possible value of raw score)/range]*100. Higher scores values indicative of greater symptom bother.|Baseline, Week 4, 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had non-missing change from baseline value at both Weeks 4 and 12.||units on a scale||Standard Error|Least Squares Mean
796203|NCT00928070|Secondary|Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score|OAB-q: a self-administered, 33-item, questionnaire that assesses how much the participant has been bothered by selected bladder symptoms. Each item rated by participant on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score – lowest possible value of raw score)/range]*100. Higher scores values indicative of greater symptom bother.|Baseline|FAS population included all participants who received at least 1 dose of study drug and had at least 1 baseline or post-baseline efficacy assessment. Here, 'N' (number of participants analyzed) signifies those participants who had non-missing change from baseline value at both Weeks 4 and 12.||units on a scale||Standard Deviation|Mean
796204|NCT00928070|Secondary|Percentage of Participants With Change From Screening in Patient Perception of Bladder Condition (PPBC) at Week 4 and 12|PPBC: a self-administered, single-item, questionnaire that asks participants to describe their perception of their bladder-related problems. The PPBC assessment is rated on a 6-point scale: 1=no problems at all, 2=some very minor problems, 3=some minor problems, 4=moderate problems, 5=severe problems, 6=many severe problems. Deterioration=score difference is greater than 0; no change=score difference is 0; minor improvement=score difference is -1; major difference=score difference is less than or equal to -2.|Screening, Week 4, 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had non-missing change from baseline value at Week 12.||percentage of participants|||Number
796205|NCT00928070|Secondary|Change From Baseline in Mean Number of Protective Undergarments Changed Due to Urinary Leakage Per 24 Hours at Week 4 and 12|Protective Undergarments included pads, protective padding, protective underwear (pull up), and briefs (diaper). The mean number of undergarments changed per 24 hours was calculated as the total number of undergarments changed divided by the total number of diary days collected at that visit. Change from baseline values were reported at week 4 for subsets of population with baseline values less than or equal to (=<) 3.5 and more than (>) 3.5 undergarments/day and at Week 12 for subsets of population with baseline values =< 2.5 and > 2.5 undergarments/day.|Baseline, Week 4, 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'n' is signifying those participants of the population subsets who were evaluated for this measure at the time point for each group respectively.||undergarments||Standard Deviation|Mean
796206|NCT00928070|Secondary|Change From Baseline in Frequency-Urgency Sum Rating Per 24 Hours at Week 4 and 12|Frequency-urgency sum is total USS ratings recorded for all micturitions in 24-hour day. Number of USS ratings per 24 hours is sum of all USS ratings divided by the total diary days collected at that visit. USS scale: 1=No feeling of urgency to 5=Unable to hold: leak urine. Numerical decrease indicates improvement.|Baseline, Week 4, 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline frequency urgency sum rating greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||units on a scale||Standard Error|Least Squares Mean
796207|NCT00928070|Secondary|Frequency-Urgency Sum Rating Per 24 Hours|Frequency-urgency sum is total USS ratings recorded for all micturitions in 24-hour day. Number of USS ratings per 24 hours is sum of all USS ratings divided by the total diary days collected at that visit. USS scale: 1=No feeling of urgency to 5=Unable to hold: leak urine.|Baseline|FAS population. Here, 'N' (number of participants analyzed) signifies those participants who had baseline frequency urgency sum rating greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||units on a scale||Standard Deviation|Mean
796239|NCT00928187|Secondary|Patients With Plasma HIV RNA < 200 Copies/ml|number of patients with plasma HIV RNA below 200 copies/ml|48 weeks|ITT||participants|||Number
796209|NCT00928070|Secondary|Change From Baseline in Mean Number of Nocturnal Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12|Nocturnal micturition-related urgency episodes had USS rating of 3 or more that occurred between time participant went to bed and time he or she arose to start next day. Number of nocturnal micturition-related urgency episodes per 24 hours was calculated as sum of all nocturnal micturition-related urgency episodes divided by total number of diary days collected at that visit.|Baseline, Week 4, 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline nocturnal urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||episodes per 24 hours||Standard Error|Least Squares Mean
796210|NCT00928070|Secondary|Mean Number of Nocturnal Micturition-related Urgency Episodes Per 24 Hours|Nocturnal micturition-related urgency episodes had USS rating of 3 or more that occurred between time participant went to bed and time he or she arose to start next day. Number of nocturnal micturition-related urgency episodes per 24 hours was calculated as sum of all nocturnal micturition-related urgency episodes divided by total number of diary days collected at that visit.|Baseline|FAS population included all participants who received at least 1 dose of study drug and had at least 1 baseline or post-baseline efficacy assessment. Here, 'N' (number of participants analyzed) signifies those participants who had baseline nocturnal urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||episodes per 24 hours||Standard Deviation|Mean
796211|NCT00928070|Secondary|Percent Change From Baseline in Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12|Percent change of micturition-related urgency episodes per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (i.e., 100*(Week 4 or 12 - baseline)/baseline).|Baseline, Week 4, 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||percent change||Standard Deviation|Mean
796212|NCT00928070|Secondary|Change From Baseline in Mean Number of Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12|The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to (>=) 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Week 4, 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||episodes per 24 hours||Standard Error|Least Squares Mean
796213|NCT00928070|Secondary|Mean Number of Micturition-related Urgency Episodes Per 24 Hours|The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to (>=) 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline|FAS population included all participants who received at least 1 dose of study drug and had at least 1 baseline or post-baseline efficacy assessment. Here, 'N' (number of participants analyzed) signifies those participants who had baseline urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||episodes per 24 hours||Standard Deviation|Mean
796214|NCT00928070|Secondary|Percent Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12|Percent change of micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (i.e., 100*(Week 4 or 12 - baseline)/baseline).|Baseline, Week 4, 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline micturition frequency greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||percent change||Standard Deviation|Mean
796215|NCT00928070|Secondary|Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4 and 12|Micturitions include episodes of voluntary micturition and episodes of UUI. UUI episodes were defined as those micturitions with USS rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine.|Baseline, Week 4, 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline micturition frequency greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||micturitions per 24 hours||Standard Error|Least Squares Mean
796216|NCT00928070|Secondary|Mean Number of Micturitions Per 24 Hours|Micturitions include episodes of voluntary micturition and episodes of UUI. UUI episodes were defined as those micturitions with USS rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine.|Baseline|FAS population included all participants who received at least 1 dose of study drug and had at least 1 baseline or post-baseline efficacy assessment. Here, 'N' (number of participants analyzed) signifies those participants who had baseline micturition frequency greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||micturitions per 24 hours||Standard Deviation|Mean
796217|NCT00928070|Secondary|Percent Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 and 12|Percent change of UUI episodes per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (i.e., 100*(Week 4 or 12 - baseline)/baseline).|Baseline, Week 4, 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline UUI episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||percent change||Standard Deviation|Mean
796240|NCT00928187|Secondary|Number of Patients With WHO Stage 3 and 4 HIV Related Events|patients having a diagnosis of HIV related event classified as stage 3 or 4|between baseline and 48 weeks|ITT||participants|||Number
796241|NCT00928187|Primary|Number of Patients With Plasma HIV RNA < 50 Copies/mL||48 weeks|ITT||participants|||Number
796269|NCT00928408|Primary|Cinacalcet Dosing Frequency|Cinacalcet dosing frequency at end of treatment|Up to Month 12|Full Analysis Set||Participants|||Number
796218|NCT00928070|Secondary|Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4|UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Week 4|FAS population included all participants who received at least 1 dose of study drug and had at least 1 baseline or post-baseline efficacy assessment. Here, 'N' (number of participants analyzed) signifies those participants who had baseline UUI episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 4.||episodes per 24 hours||Standard Error|Least Squares Mean
796219|NCT00928070|Primary|Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12|UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Week 12|FAS population. Last observation carried forward (LOCF) method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline UUI episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||episodes per 24 hours||Standard Error|Least Squares Mean
796220|NCT00928070|Primary|Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours|UUI episodes were defined as those with the Urinary Sensation Scale (USS) rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline|Full analysis set (FAS) population included all participants who received at least 1 dose of study drug and had at least 1 baseline or post-baseline efficacy assessment. 'N' (number of participants analyzed) signifies those participants who had baseline UUI episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||episodes per 24 hours||Standard Deviation|Mean
796221|NCT00928083|Secondary|OZ439 Rac|"Accumulation index is the ratio of drug exposure observed during a dosing interval at steady-state divided by drug exposure after a single first dose, as described by the following equations:
Accumulation index (Rac) = AUC0-(Day 3)/ AUC0-(Day 1)"|Samples collected from Pre-dose up to 96h post dose|Pharmacokinetics Population received multiple dosing only. This PK parameter is not applicable in a single dose setting.||ratio||Geometric Coefficient of Variation|Geometric Mean
796222|NCT00928083|Secondary|OZ439 t1/2|Apparent terminal half-life (t1/2)|Samples collected from Pre-dose up to 96h post dose|Pharmacokinetics Population||hours||Geometric Coefficient of Variation|Geometric Mean
796223|NCT00928083|Secondary|OZ439 Tmax|Time to maximum observed plasma drug concentration of OZ439|Samples collected from Pre-dose up to 96h post dose|Pharmacokinetics Population||hours||Full Range|Median
796224|NCT00928083|Secondary|OZ439 Cmax|Maximum observed plasma drug concentration (Cmax).|Samples collected from Pre-dose up to 96h post dose|Pharmacokinetics Population||ng/ml||Geometric Coefficient of Variation|Geometric Mean
796225|NCT00928083|Secondary|OZ439 AUC0-∝|Area under the plasma concentration-time curve from zero to infinity (AUC0-∝).|Samples collected from Pre-dose up to 96h post dose|Pharmacokinetics Population||ng.h/ml||Geometric Coefficient of Variation|Geometric Mean
796226|NCT00928083|Secondary|OZ439 AUC0-t|Area under the plasma concentration-time curve from zero to time t of the last measured concentration above the limit of quantification (AUC0-t).|Samples collected from Pre-dose up to 96h post dose|Pharmacokinetics Population||ng.h/ml||Geometric Coefficient of Variation|Geometric Mean
796227|NCT00928083|Primary|Adverse Events|Safety/Tolerability evaluation took into account the recorded AE profile, clinical laboratory safety tests, vital signs, 12 lead and continuous (Parts A and C) ECG monitoring, audiometry/Brainstem Auditory Evoked Potentials (BAEP) parameters (Parts A and C) including any additional tests required to evaluate any safety concerns.|From screening and at 10 (+/-2) days after last dose of study medication|||participants|||Number
796228|NCT00928174|Primary|Prostate Specific Antigen (PSA) Outcome Correspondence to Imaging Results With Fluorine-18 Fluorocholine PET/CT|The percentage of patients within a given prostate specific antigen range found to have at least one abnormal lesion demonstrating increased fluorine-18 fluorocholine uptake on positron emission tomography (PET) imaging consistent with the clinical diagnosis of metastatic or recurrent prostate cancer.|Concurrent with PET Procedure|Outcome Measure Data Table reflects data from the 22 subjects completing the current study.||%PET-positive cases in a given PSA range|||Number
796229|NCT00928187|Secondary|Number of Patients With HIV Plasma Viral Load < 200 Copies/ml|number of patients having a plasma viral load below 200 copies/ml at week 24|Week 24|ITT||Participants|||Count of Participants
796230|NCT00928187|Secondary|Number of Patients With HIV Plasma Viral Load < 50 Copies/ml|Snapshot of patients with HIV viral load less then 50 copies/ml at week 24|Week 24|ITT||Participants|||Count of Participants
796231|NCT00928187|Secondary|Development of Metabolic Syndrome|number of patients developing metabolic syndrome over a period of 48 weeks|from baseline to week 48|population with data available||Participants|||Count of Participants
796232|NCT00928187|Secondary|Number of Patients With Resistance Mutations|number of patients with resistance mutations after second line treatment failure (HIV RNA> 1000 copies/ml)|between W12 and W48|patients who failed second line (2 HIV RNA measure above 1000 copies/ml)||participants|||Number
796233|NCT00928187|Secondary|Adherence|number of patients in different categories of adherence as measured by questionnaire|between baseline and W48|patients with data available||participants|||Number
796234|NCT00928187|Secondary|Tolerance: Equal or Superior to a 25% Reduction in eGFR (Glomerular Filtration Rate)|evaluation of estimated glomerular filtration rate and number of participant with a decrease equal or superior to 25% of the baseline value|between baseline and W48|ITT||participants|||Number
796235|NCT00928187|Secondary|Tolerance: Neuropathies (Grade 1 to 4)|any symptom of peripheral neuropathy|between baseline and W48|ITT||participants|||Number
796236|NCT00928187|Secondary|Tolerance: Gastrointestinal Complains|Gastrointestinal complaints (grade 1 to 4) between baseline and W48.|between baseline and 48 weeks|ITT||participants|||Number
796237|NCT00928187|Secondary|Number of Patients Discontinuing Study Treatment|number of patients discounting treatment because of adverse events|between baseline and W48|ITT||participants|||Number
796238|NCT00928187|Secondary|Gain in CD4 Cells Between Baseline and W48|median gain in circulating CD4 cells between baseline and W48|between baseline and 48 weeks|ITT with data available||cell/mm3||Inter-Quartile Range|Median
796242|NCT00928252|Primary|Proportional Hazards Regression Analysis of Time to PSA Progression|PSA levels measured from the start of treatment over the period of follow-up were recorded. Time to PSA progression was calculated as the number of days from the start of treatment to the date of the first PSA test result that represented a 30% or greater increase from the PSA nadir, confirmed on the basis of repeated PSA measurements. For proportional hazards regression analysis, the percentage change in PSA level within 15 wk of starting treatment was calculated, using a 50% or greater decrease in PSA level as a predefined definition of PSA re- sponse based on Prostate Cancer Working Group guidelines.|Up to 15 week post-chemotherapy|Twenty patients met the study criteria for an metabolically active tumor volume (MATV) response (30% or greater decline in MATV) response.||Hazard Ratio||95% Confidence Interval|Number
796243|NCT00928252|Primary|Time to PSA Progression|Time to PSA Progression between patients exhibiting MATV reduction greater or equal to 30% vs. MATV reduction less than 30%.|2 years|||days||Standard Error|Mean
796244|NCT00928252|Primary|Metabolically Active Tumor Volume (MATV) Response|Number of patients achieving 30% or greater reduction in MATV measured on 18F-fluorocholine PET/CT|21 to 98 days|||Participants|||Count of Participants
796245|NCT00928304|Secondary|Consistency Between Visual and Quantitative Efficacy|For a comparison of the results of the visual assessment with the quantitative assessment, descriptive Standardized Uptake Value Ratio (SUVR) statistics were computed separately for DS subjects with an abnormal/normal majority read of the PET scan (DS-PET+/DS-PET-). The SUV is defined as the ratio of (1) the tissue radioactivity concentration c (in MBq/kg) at time point t, and (2) the injected activity (in MBq, extrapolated to the same time t) divided by the body weight (in kg). These SUV numbers from regions of interest were then used to derive SUV ratios (SUVR) using the SUV from the cerebellar cortex as reference.|100 - 120 min|||SUVR||Standard Deviation|Mean
796246|NCT00928304|Secondary|Quantitative Parameters Standard Uptake Value Ratio|The Standard Uptake Value Ratios for florbetaben signal in the frontal cortex, posterior cingulate, lateral temporal cortex, parietal cortex, and cerebellum (white matter) were determined as a quantitative measure of tracer uptake. The SUV is defined as the ratio of (1) the tissue radioactivity concentration c (in MBq/kg) at time point t, and (2) the injected activity (in MBq, extrapolated to the same time t) divided by the body weight (in kg). These SUV numbers from regions of interest were then used to derive SUV ratios (SUVR) using the SUV from the cerebellar cortex as reference.|100 - 120 min p.i.|All Down Syndrome subjects and healthy volunteers enrolled in the study were included in this analysis||SUVR||Standard Deviation|Mean
796247|NCT00928304|Secondary|Sensitivity Results in the Down Syndrome Age Subgroups|The majority read sensitivity (percentage of DS subjects positive for cerebral beta-amyloid by majority read) was computed for the group of DS subjects with age equal to or below the median age (DS-young) and for DS subjects with age above the median age (DS-old). The median age was 46 yrs, with 3 subjects being exactly 46 yrs old. As defined, these subjects were assigned to the DS-young group.|100 - 120 min|All Down Syndrome subjects (n=39) were analyzed for this outcome.||percentage of subjects||95% Confidence Interval|Number
796248|NCT00928304|Primary|Sensitivity of the Independent Visual Assessment of Detecting Cerebral Amyloid-beta in Individuals With Down Syndrome and Specificity in Subjects Without Down Syndrome|The primary variables are sensitivity (percentage of DS subjects positive for cerebral beta-amyloid) and specificity (percentage of healthy volunteers negative for cerebral beta-amyloid) of brain uptake of florbetaben based on the majority read of the visual assessment by three independent blinded readers of PET images obtained 100 to 120 minutes post-injection of florbetaben.|100-120 min|All subjects in the down syndrome population and healthy volunteers were included in this analysis.||percentage of subjects||95% Confidence Interval|Number
796249|NCT00928395|Secondary|Change in Voiding Diary Parameters.||every three months for 36 months||||||
796250|NCT00928395|Secondary|Change in OAB-q and SF-36 Questionnaires.||every three months for 36 months||||||
796251|NCT00928395|Secondary|GRA Subset of Individual Bladder Symptom Components to Include Urgency, Frequency and Urge Incontinence.||every three months for 36 months||||||
796252|NCT00928395|Primary|"Proportion of Patients Reporting Moderately or Markedly Improved on the Global Response Assessment (GRA) at 36 Months as Compared to Baseline"|The GRA asked patients, “Compared to the last time you completed this questionnaire, how would you rate your bladder symptoms now?” and was a 7-level Assessment (markedly improved, moderately improved, slightly improved, no change, slightly worse, moderately worse, markedly worse).|36 months total|||Proportion of Patients||95% Confidence Interval|Number
796253|NCT00928408|Primary|Reason for Prescribing Cinacalcet||Initiation|Full Analysis Set||Participants|||Number
796254|NCT00928408|Primary|Percent Change From Baseline to Month 12 in Bone Mineral Density (g/cm^2). Anatomic Site: Lumbar Spine; Densitometer: Hologic|Results only shown where >10 patients have data|Baseline to Month 12|Full Analysis Set - Participants with Observed Data||Percent change||Inter-Quartile Range|Median
796255|NCT00928408|Primary|Percent Change From Baseline to Month 12 in Bone Mineral Density (g/cm^2). Anatomic Site: Femoral Neck; Densitometer: Hologic|Results only shown where >10 patients have data|Baseline to Month 12|Full Analysis Set - Participants with Observed Data||Percent change||Inter-Quartile Range|Median
796256|NCT00928408|Primary|Change From Baseline to Month 12 in Albumin-corrected Serum Calcium||Baseline to Month 12|Full Analysis Set - Participants with Observed Data||mmol/L||Standard Error|Mean
796257|NCT00928408|Primary|Change From Baseline to Month 6 in Albumin-corrected Serum Calcium||Baseline to Month 6|Full Analysis Set - Participants with Observed Data||mmol/L||Standard Error|Mean
796258|NCT00928408|Primary|Change From Baseline to Month 3 in Albumin-corrected Serum Calcium||Baseline to Month 3|Full Analysis Set - Participants with Observed Data||mmol/L||Standard Error|Mean
796259|NCT00928408|Primary|Incidence of an Albumin-corrected Serum Calcium Concentration ≤ 2.6 mmol/L (10.3 mg/dL) at Month 12||Month 12|Full Analysis Set - Participants with Observed Data||Participants|||Number
796260|NCT00928408|Primary|Incidence of an Albumin-corrected Serum Calcium Concentration ≤ 2.6 mmol/L (10.3 mg/dL) at Month 6||Month 6|Full Analysis Set - Participants with Observed Data||Participants|||Number
796261|NCT00928408|Primary|Incidence of an Albumin-corrected Serum Calcium Concentration ≤ 2.6 mmol/L (10.3 mg/dL) at Month 3||Month 3|Full Analysis Set - Participants with Observed Data||Participants|||Number
796262|NCT00928408|Primary|Achievement of a Reduction From Baseline of Albumin-corrected Serum Calcium ≥ 0.25 mmol/L (1 mg/dL) at Month 12|Baseline is pre-cinacalcet.|Month 12|Full Analysis Set - Participants with Observed Data||Participants|||Number
796279|NCT00928421|Primary|Responders to Treatment, Assessed by Duplex Ultrasound|Responders; elimination of reflux through the saphenofemoral junction and/or coplete occlusion of the great saphenous vein at 8 weeks, as measured by duplex ultrasound.|8 weeks|||participants|||Number
796280|NCT00928434|Secondary|Percent Change From Baseline in Serum Testosterone Levels|Percent change from Baseline in serum testosterone levels was measured.|Phase A Visit 1-8 and Phase B Visit 9-15.|Analysis set consist of Full Phase B analysis set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.||Percent change||Standard Deviation|Mean
796281|NCT00928434|Secondary|Absolute Change From Baseline in Serum Testosterone Levels|Absolute Change From Baseline in Serum Testosterone Levels was measured.|Phase A Visit 1-8 and Phase B Visit 9-15.|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.||ng/mL||Standard Deviation|Mean
796282|NCT00928434|Secondary|Time to Return to Normal Range (≥1.5 ng/mL) or Baseline Testosterone Level|The time to return to normal range (≥1.5 ng/mL) or Baseline testosterone level in the DI group was counted from the start of Phase B at Day 196 (i.e. 28 days after last injection of degarelix).|During Phase B|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.||Days||95% Confidence Interval|Median
796283|NCT00928434|Secondary|Time to Return to Testosterone >0.5 ng/mL Level in the DI Treatment Group|The time to testosterone >0.5 ng/mL level in the DI group was counted from the start of Phase B at Day 196 (i.e. 28 days after last injection of degarelix)|During Phase B|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.||Days||95% Confidence Interval|Median
796284|NCT00928434|Secondary|Percentage of Subjects With a Serum PSA Level ≤4.0 ng/mL|Percentage of Subjects With a Serum PSA Level ≤4.0 ng/mL was measured during the study period.|At 14 months|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.||Percentage of patients||95% Confidence Interval|Number
796285|NCT00928434|Secondary|Change From Baseline in Sexual Function as Assessed by the SFI: Total SFI Score|The SFI is a multidimensional, self-report instrument specifically designed to evaluate sexual function and satisfaction of men on treatment or with conditions that may affect sexual function. It consists of 11 questions which assess patient function in four domains: Sexual drive, Erection, Ejaculation, and Problem assessment, and a question in regards to overall assessment of sexual function. Total SFI score ranges from 0 to 44. A higher scores represent better sexual function.|During 14 months|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.||Scores on a scale||95% Confidence Interval|Mean
796286|NCT00928434|Secondary|Change From Baseline in Sexual Function as Assessed by the SFI: Overall Satisfaction With Sex Life|"The SFI is a multidimensional, self-report instrument specifically designed to evaluate sexual function and satisfaction of men on treatment or with conditions that may affect sexual function. It consists of 11 questions which assess patient function in four domains: Sexual drive, Erection, Ejaculation, and Problem assessment, and a question in regards to overall assessment of sexual function.
Overall satisfaction domain consist of single question and is scored on a scale of 0-4 (0=minimum, 4=maximum). A higher score represent better sexual function."|During 14 months|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.||Scores on a scale||95% Confidence Interval|Mean
796287|NCT00928434|Secondary|Change From Baseline in Sexual Function as Assessed by the SFI: Problem Assessment|"The SFI is a multidimensional, self-report instrument specifically designed to evaluate sexual function and satisfaction of men on treatment or with conditions that may affect sexual function. It consists of 11 questions which assess patient function in four domains: Sexual drive, Erection, Ejaculation, and Problem assessment, and a question in regards to overall assessment of sexual function.
Problem assessment domain consist of 2 questions and are scored on a scale of 0-4 (0=minimum, 4=maximum). Total score for the problem assessment domain ranges from 0 to 8. A higher scores represent better sexual function."|During 14 months|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.||Scores on a scale||95% Confidence Interval|Mean
796288|NCT00928434|Secondary|Change From Baseline in Sexual Function as Assessed by the SFI: Ejaculation|"The SFI is a multidimensional, self-report instrument specifically designed to evaluate sexual function and satisfaction of men on treatment or with conditions that may affect sexual function. It consists of 11 questions which assess patient function in four domains: Sexual drive, Erection, Ejaculation, and Problem assessment, and a question in regards to overall assessment of sexual function.
Ejaculation domain consist of 2 questions and are scored on a scale of 0-4 (0=minimum, 4=maximum). Total score for the ejaculation domain ranges from 0 to 8. A higher scores represent better sexual function."|During 14 months|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.||Scores on a scale||95% Confidence Interval|Mean
796312|NCT00928512|Secondary|Anti-CCP (Cyclic Citrulinated Peptide) Antibodies Concentrations at Baseline and at Week 16|Only values that were above normal range (20 units) were included.|Baseline, Week 16|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.||Units||Standard Deviation|Mean
796359|NCT00928746|Primary|Actuations Dispensed|Actuations dispensed is determined by the weight differential of the canister over the course of the study divided by the shot weight|21 Days|The primary analysis was performed using the Full Analysis Set (FAS)||Count||Standard Deviation|Median
796289|NCT00928434|Secondary|Change From Baseline in Sexual Function as Assessed by the SFI: Erection|"The SFI is a multidimensional, self-report instrument specifically designed to evaluate sexual function and satisfaction of men on treatment or with conditions that may affect sexual function. It consists of 11 questions which assess patient function in four domains: Sexual drive, Erection, Ejaculation, and Problem assessment, and a question in regards to overall assessment of sexual function.
Erection domain consist of 3 questions and are scored on a scale of 0-4 (0=minimum, 4=maximum). Total score for the erection domain ranges from 0 to 12. A higher scores represent better sexual function."|During 14 months|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.||Scores on a scale||95% Confidence Interval|Mean
796290|NCT00928434|Secondary|Change From Baseline in Sexual Function as Assessed by the Sexual Function Index (SFI): Sexual Drive|"The SFI is a multidimensional, self-report instrument specifically designed to evaluate sexual function and satisfaction of men on treatment or with conditions that may affect sexual function. It consists of 11 questions which assess patient function in four domains: Sexual drive, Erection, Ejaculation, and Problem assessment, and a question in regards to overall assessment of sexual function.
Sexual drive domain consist of 2 questions and are scored on a scale of 0-4 (0=minimum, 4=maximum). Total score for the sexual drive domain ranges from 0 to 8. A higher scores represent better sexual function."|During 14 months|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.||Scores on a scale||95% Confidence Interval|Mean
796291|NCT00928434|Secondary|Change From Baseline in Quality of Life as Assessed by the FACT-P: Total FACT-P Score|The FACT-P is a multidimensional, self-report quality of life (QoL) instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each question is rated on a scale from 0 to 4, and then combined to produce sub-scale scores for each domain, as well as a global QoL score. Total FACT-P scores ranges from 0 to 156. Higher scores represent better QoL.|During 14 months|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.||Scores on a scale||95% Confidence Interval|Mean
796292|NCT00928434|Secondary|Change From Baseline in Quality of Life as Assessed by the FACT-P : Additional Concerns|"The FACT-P is a multidimensional, self-report quality of life (QoL) instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each question is rated on a scale from 0 to 4, and then combined to produce sub-scale scores for each domain, as well as a global QoL score.
Additional concerns consist of 12 items and scored on a scale of 0-4 (0=Not at all; 1=A little bit; 2=Somewhat; 3=Quite a bit; 4=Very much). Total score for the additional concerns ranges from 0 to 48. Higher scores represent better QoL."|During 14 months|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.||Scores on a scale||95% Confidence Interval|Mean
796293|NCT00928434|Secondary|Change From Baseline in Quality of Life as Assessed by the FACT-P : Functional Well-being|"The FACT-P is a multidimensional, self-report quality of life (QoL) instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each question is rated on a scale from 0 to 4, and then combined to produce sub-scale scores for each domain, as well as a global QoL score.
Functional well-being consist of 7 items and scored on a scale of 0-4 (0=Not at all; 1=A little bit; 2=Somewhat; 3=Quite a bit; 4=Very much). Total score for the functional well-being sub scale ranges from 0 to 28. Higher scores represent better QoL."|During 14 months|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.||Scores on a scale||95% Confidence Interval|Mean
796294|NCT00928434|Secondary|Change From Baseline in Quality of Life as Assessed by the FACT-P : Social Well-being|"The FACT-P is a multidimensional, self-report quality of life (QoL) instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each question is rated on a scale from 0 to 4, and then combined to produce sub-scale scores for each domain, as well as a global QoL score.
Social well-being consist of 7 items and scored on a scale of 0-4 (0=Not at all; 1=A little bit; 2=Somewhat; 3=Quite a bit; 4=Very much). Total score for the social well-being sub scale ranges from 0 to 28. Higher scores represent better QoL."|During 14 months|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.||Scores on a scale||95% Confidence Interval|Mean
796295|NCT00928434|Secondary|Change From Baseline in Quality of Life as Assessed by the FACT-P : Emotional Well-being|"The FACT-P is a multidimensional, self-report quality of life (QoL) instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each question is rated on a scale from 0 to 4, and then combined to produce sub-scale scores for each domain, as well as a global QoL score.
Emotional well-being consist of 6 items and scored on a scale of 0-4 (0=Not at all; 1=A little bit; 2=Somewhat; 3=Quite a bit; 4=Very much). Total score for the emotional well-being sub scale ranges from 0 to 24. Higher scores represent better QoL.Higher scores represent better QoL."|During 14 months|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.||Scores on a scale||95% Confidence Interval|Mean
796296|NCT00928434|Secondary|Change From Baseline in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy–Prostate (FACT-P) : Physical Well-being|"The FACT-P is a multidimensional, self-report quality of life (QoL) instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each question is rated on a scale from 0 to 4, and then combined to produce sub-scale scores for each domain, as well as a global QoL score.
Physical well-being consist of 7 items and scored on a scale of 0-4 (0=Not at all; 1=A little bit; 2=Somewhat; 3=Quite a bit; 4=Very much). Total score for the physical well-being sub scale ranges from 0 to 28. Higher scores represent better QoL."|During 14 months|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.||Scores on a scale||95% Confidence Interval|Mean
796297|NCT00928434|Secondary|Percent Change From Baseline in Serum PSA Levels|Percent change from Baseline in serum PSA levels during the study period was measured.|Phase A Visit 1-8 and Phase B Visit 9-15.|Analysis set consist of Full Phase B analysis set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.||Percent change||Standard Deviation|Mean
796298|NCT00928434|Secondary|Absolute Change From Baseline in Serum PSA Levels|Absolute change from Baseline in serum PSA levels during the study period was measured.|Phase A Visit 1-8 and Phase B Visit 9-15.|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.||ng/mL||Standard Deviation|Mean
796299|NCT00928434|Primary|Percentage of Patients With Serum PSA Levels ≤4.0 ng/mL|Percentage of patients with serum PSA levels ≤4.0 ng/mL at 14 month was presented.|At 14 month|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.||Percentage of patients||95% Confidence Interval|Number
796300|NCT00928486|Secondary|Kaplan-Meier Estimates of Duration of Response (DoR)|Duration of response was defined as the time from the first observation of a response (CR, RR or PR) to the first documented disease progression or relapse. For participants who did not progress during the study, duration of response was censored at the last adequate response assessment showing evidence of no disease progression. Disease progression is defined as an increase in M-protein serum monoclonal paraprotein and/or urine paraprotein or evidence of bone marrow plasmacytosis and plasma cells, an appearance of new or existing soft tissue plasmacytomas, an appearance of new or existing lytic bone lesions and/or hypercalcemia >11.5mg/dL|From the time of the first dose of study drug to study completion; the median duration on study was 42.1 weeks|Efficacy Population = all participants who received at least one dose of study drug, who were evaluated for efficacy at least once after study drug dose administration and who met inclusion criteria who were responders||weeks||95% Confidence Interval|Median
796301|NCT00928486|Secondary|Myeloma Response Rate|Overall myeloma response rate was determined by the investigator using the Myeloma Response Determination Criteria adapted from Bladé criteria. A responder is any patient who showed at least a partial response. Overall myeloma response rate is defined as the percentage of participants who achieved a Complete Response (CR), plus a Remission Response (RR), plus a Partial Response (PR). A CR is the disappearance of monoclonal paraprotein and maintained for ≥ 6 weeks. RR is a 75-99% reduction in the level of the serum monoclonal paraprotein compared to baseline; 90-99% reduction in 24-hr urinary light chain excretion. PR is a 50-74% reduction in the level of monoclonal paraprotein compared to baseline; 50-89% reduction in 24-hr urinary light chain excretion.|From the time of the first dose of study drug to study completion; median duration on study was 42.1 weeks|Efficacy Population = all participants who received at least one dose of study drug, who were evaluated for efficacy at least once after study drug dose administration and who met inclusion criteria||percentage of participants|||Number
796302|NCT00928486|Primary|Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAE)|A TEAE was defined as any AE that started on or after the first dose of study drug, and within End of Study (EOS) (28 days after the last dose of study drug received). A serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability; is a congenital anomaly/birth defect; or constitutes an important medical event. The intensity of AEs were graded 1 to 5 according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. For all other AEs not described in the CTCAE criteria, the intensity was assessed by the investigator as mild grade (Grade 1), moderate (grade 2), severe (grade 3), life-threatening (grade 4) or death (grade 5)|Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks|Safety population included all 25 participants who received at least one dose of study drug.||participants|||Number
796303|NCT00928512|Secondary|Change From Baseline in ACR Component: Erythrocyte Sedimentation Rate (ESR) at Week 16|Blood for ESR, which is helpful to diagnose inflammatory diseases and to monitor disease activity and response to therapy, was obtained at the visits.|Baseline, week 16|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.||mm/hr||Standard Error|Least Squares Mean
796304|NCT00928512|Secondary|Change From Baseline in ACR Component: High Sensitivity C-reactive Protein (hsCRP)|Blood for this assessment was obtained at the visits in order to identify the presence of inflammation, to determine its severity, and to monitor response to treatment.Since the results of this test may have unblinded study personnel, results from the central lab were provided for screening and baseline only. The hsCRP results from samples collected during the treatment period were revealed only after final database lock.|Baseline, week 16|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.||mg/L||Standard Error|Least Squares Mean
796305|NCT00928512|Secondary|Change From Baseline in ACR Component: Health Assessment Questionnaire (HAQ©) Score at Week 16|HAQ© was used to assess physical ability and functional status of patients as well as quality of life at the visits in these 8 categories assessed by the Disability Index: dressing & grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Patients report amount of difficulty they have in performing 2 or 3 specific activities. There are 4 possible responses (0, 1, 2, 3) for these questions which include types of assistance, if any; the participant uses for his/her usual activities: 0: without any difficulty- No assistance is needed; 1: with some difficulty - A special device is used by the patient in his/her usual activities; 2: with much difficulty - The patient usually needs help from another person. 3: Unable to do - the patient usually needs both a special device and help from another person. Scores of 0 - 1 are generally considered to represent mild to moderate difficulty, 1-2 moderate to severe disability, and 2 -3 severe to very severe disability.|Baseline, week 16|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.||scores on a scale||Standard Error|Least Squares Mean
796306|NCT00928512|Secondary|Change From Baseline in ACR Component: Physician’s Global Assessment of Disease Activity at Week 16|"The physician’s global assessment of disease activity was performed at the visits usingon a 100 mm non-anchored visual analog scale, from no arthritis (0) activity to maximal arthritis (100) activity, after the question, Considering all the ways your arthritis affects you, draw a line on the scale for how well you are doing."|Baseline, week 16|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.||VAS in mm||Standard Error|Least Squares Mean
796307|NCT00928512|Secondary|Change From Baseline in ACR Component: Patient's Global Assessment of Disease Activity at Week 16|"The patient’s global assessment of disease activity was performed at the visits on a 100 mm non-anchored visual analog scale, from no arthritis (0) activity to maximal arthritis (100) activity, after the question, Considering all the ways your arthritis affects you, draw a line on the scale for how well you are doing."|Baseline, week 16|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.||VAS in mm||Standard Error|Least Squares Mean
796308|NCT00928512|Secondary|Change From Baseline in ACR Component: Patient's Assessment of RA Pain at Week 16|"The patient's assessment of pain was performed at all visits using 100 mm visual analog scale (VAS) ranging from no pain to unbearable pain after the question Please indicate with a vertical mark ( | ) through the horizontal line the most pain you had from your rheumatoid arthritis over the last 24 hours."|Baseline, week 16|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.||VAS in mm||Standard Error|Least Squares Mean
796309|NCT00928512|Secondary|Change From Baseline in ACR Component: Adjusted Tender 28-joint Count at Week 16|The ACR tender joint count (28 joints) was done by scoring several different aspects of tenderness as assessed by pressure and joint manipulation on physical examination. Joint counts were performed according to the visit schedule by the physician or by well trained personnel. The following 28 joints were assessed for tenderness and swelling: metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2). If the number of joints for which data were available (e.g., T) was less than 28, the number of tender joints (e.g., t) was scaled up proportionately (i.e., 28*(t/T)).|Baseline, week 16|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.||tender joints||Standard Error|Least Squares Mean
796310|NCT00928512|Secondary|Change From Baseline in Disease Activity Score 28 Using ESR (DAS28-ESR) at Week 16|The DAS28 is a measure of disease activity in Rheumatoid Arthritis (RA). The score is calculated by a complex mathematical formula, which includes the number of tender and swollen joints (out of a total of 28), the erythrocyte sedimentation rate (ESR) or hsCRP, and the patient’s ‘global assessment of global health (indicated by marking a 100 mm line between very good and very bad). A DAS28 score greater than 5.1 implies active disease, less than 3.2 well controlled disease, and less than 2.6 remission.The DAS28 was also derived using erythrocyte sedimentation rate (ESR) (referred to as DAS28-ESR).|Baseline, week 16|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.||scores on a scale||Standard Error|Least Squares Mean
796311|NCT00928512|Secondary|Change From Baseline in ACR Component: Adjusted Swollen 28-joint Count at Week 16|Synovial fluid and/or soft tissue swelling but not bony overgrowth represents a positive result for swollen joint count. Joint counts were performed according to the visit schedule by the physician or by well trained personnel. Whenever possible, the same evaluator performed these assessments at all visits. The following 28 joints were assessed for tenderness and swelling: metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2). If the number of joints for which data were available (e.g., S) was less than 28, the number of swollen joints (e.g., s) was scaled up proportionately (i.e., 28*(s/S)).|Baseline, week 16|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.||swollen joints||Standard Error|Least Squares Mean
797483|NCT00941655|Secondary|Median Hospital Stay After Initial Surgery|Recuperation period following complex surgery for this disease.|1-10 weeks|||Days||Full Range|Median
796313|NCT00928512|Secondary|Change From Baseline in Rheumatoid Factor (RF) Concentrations at Week 16|Only values that were above normal range (12 U/mL) were were included.|Baseline, Week 16|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.||U/mL||Standard Deviation|Mean
796314|NCT00928512|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Response at Week 16|The distribution of EULAR response criteria was according to DAS28-CRP at Week 16. EULAR response criteria are based on DAS28-CRP status in combination with DAS28-CRP improvements. The EULAR response criteria are as follows: Week 16 DAS28-CRP <3.2 with DAS28-CRP improvement >1.2 corresponds to 'good response'; Week 16 DAS28-CRP <3.2 with DAS28-CRP improvement between 0.6 to 1.2, or Week 16 DAS28-CRP between 3.2 to 5.1 with DAS28-CRP improvement >1.2 or from 0.6 to 1.2, or WeeK 16 DAS28-CRP >5.1 with DAS28-CRP improvement >1.2 correspond to 'moderate response; Week 16 DAS28-CRP <3.2 with DAS28-CRP improvement <0.6, or Week 16 DAS28-CRP between 3.2 to 5.1 with DAS28-CRP improvement <0.6, or Week 16 DAS28-CRP >5.1 with DAS28-CRP improvement between 0.6 to 1.2 or <0.6 correspond to 'no response'.|Week 16|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.||Percentage of participants|||Number
796315|NCT00928512|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) at Week 16|The Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-Fatigue©) is a 13- item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants responded to each item on a 5-point Likert-type scale (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; 4 = very much) based on their experience of fatigue during the past 2 weeThe scale score was computed by summing the item scores, after reversing those items that were worded in the negative direction. When there were missing item scores, the subscale score was computed by summing the non-missing item scores, multiplying by 13 (the total number of items in the scale) and dividing by the number of non-missing items. The latter rule applied only when at least half of the items (seven or more) were non-missing. FACIT-Fatigue subscale scores range from 0 to 52, where higher scores represent less fatigue.|Baseline, Week 16|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.||scores on a scale-change from baseline||Standard Deviation|Mean
796316|NCT00928512|Secondary|Change From Baseline in Medical Outcome Short Form (36) Health Survey (SF-36® v2)|The SF-36 Scale is a 36-item, patient-reported survey which measures overall quality of life. It consists of 8 subscales (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health) which can be aggregated to derive a physical-component summary score and a mental-component score. Scores are normally determined with the use of norm-based methods which standardize scores based on an assessment of the general U.S. population free of chronic conditions. The scores range for each subscale from 0 to 10, and the composite score ranges from 0 to 100, with the higher scores indicative of better health.|Baseline, week 16|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.||scores on a scale-change from baseline||Standard Deviation|Mean
796317|NCT00928512|Secondary|Change From Baseline in Disease Activity Score 28 Using CRP (DAS28-CRP)|The DAS28 is a measure of disease activity in Rheumatoid Arthritis (RA). The score is calculated by a complex mathematical formula, which includes the number of tender and swollen joints (out of a total of 28), the erythrocyte sedimentation rate (ESR) or hsCRP, and the patient’s ‘global assessment of global health (indicated by marking a 100 mm line between very good and very bad). A DAS28 score greater than 5.1 implies active disease, less than 3.2 well controlled disease, and less than 2.6 remission. The DAS28-CRP was derived from swollen joint count, tender joint count, hsCRP and patient’s global assessment of disease activity.|Baseline, week 16|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.||scores on a scale||Standard Error|Least Squares Mean
796318|NCT00928512|Secondary|Number of Participants Who Achieved an ACR20, ACR50 or ACR70 Response up to Week 16|A participant was considered as improved according to the ACR20, ACR50 or ACR70 criteria if he/she had as least a 20%, 50% or 70% improvement, respectively, in both the tender and the swollen 28-joint count, and in at least 3 of the following 5 measures: patient's assessment of rheumatoid athritis (RA) pain, patient's global assessment of disease activity, physician's global assessment of disease activity, patient's self-assessed disability and acute phase rectant or Erythrocyte sedimentation rate (ESR).|at Weeks2, 4, 8, 12, 16|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.||Participants|||Number
796331|NCT00928668|Secondary|Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 4 Hours|Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 4 hours|4 hours post dose|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and post-dose data for at least two periods for the same endpoint.||Log base 2 (mg/ml)||Standard Error|Least Squares Mean
796332|NCT00928668|Secondary|Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 30 Minutes|Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 30 minutes|30 minutes post dose|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and post-dose data for at least two periods for the same endpoint.||Log base 2 (mg/ml)||Standard Error|Least Squares Mean
796319|NCT00928512|Secondary|Number of Participants Who Achieved an ACR50 or ACR70 Response at Week 16|A participant was considered as improved according to the ACR50 or ACR70 criteria if he/she had at least a 50% or 70% improvement, respectively, in both the tender and the swollen 28-joint count, and in at least 3 of the following 5 measures: patient's assessment of rheumatoid athritis (RA) pain, patient's global assessment of disease activity, physician's global assessment of disease activity, patient self-assessed disability (Health Assessment Questionnaire [HAQ©] score) and Acute phase reactant (C-reactive protein [hsCRP]/ESR). Participants were defined as ACR50/70 responders at a given post-randomization visit if they satisfied the ACR50/70 criteria, respectively. Participants were considered ACR50/70 nonresponders if they failed the ACR50/70 criteria respectively. Participants who prematurely discontinued from study due to insufficient therapeutic effect were also considered nonresponders.|Week 16|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.||Participants|||Number
796320|NCT00928512|Primary|Number of Participants With American College of Rheumatology Response of 20 (ACR20) at 16 Weeks|A participant was considered to have achieved the incidence of response (ACR20 criteria) if he/she had at least a 20% improvement in both the tender and swollen 28-joint counts and had at least 20% improvement in at least 3 of the following 5 measures: patient's assessment of rheumatoid athritis (RA) pain, patient's global assessment of disease activity, physician's global assessment of disease activity, patient's self-assesseddisability (Health Assessment Questionnaire [HAQ©] score)and acute phase rectant (C-reactive protein [hsCRP]/ESR).|16cweeks|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.||Participants|||Number
796321|NCT00928642|Secondary|To Assess the Effects of Prognostic Variables; Initial Performance Status; Platinum Sensitivity, and Mucinous (or Clear Cell)Histology on Progression-free Survival Overall.|The study was stopped after 8 subjects. It was not possible to perform meaningful analysis on prognostic variables. this outcome measure was not done.|Until disease progression||||||
796322|NCT00928642|Secondary|To Estimate the Clinical Response Rate(Partial and Complete Response as Defined Under the SWOG Criterial)|"Using SWOG criteria for response of measurable disease, subject best response was assessed. First assessment was 6 weeks after starting treatment. Subjequent evaluations were every 6 weeks in patients who remained on study.
Repsonse rate was the sum of Complete Repsonse and Partial Response."|until disease progression or unacceptable toxicity|All subjects were assessed after 6 weeks of treatment and reassessed at 6 week intervals||participants|||Number
796323|NCT00928642|Secondary|To Determine the Distribution of the Overall Survival|All subjects were followed after treatment was complete to assess overall survival.|Until death|||months||Full Range|Median
796324|NCT00928642|Secondary|Tumor Response Rates Using Modified SWOG Criteria to the Combination of Gleevec and Gemzar in Patients With Relapsed Ovarian Cancer Who Have Failed at Least One Prior Chemotherapy Treatment.|"Best response to thearpy was assessed using modified SWOG criteria (same as for outcome masure #1). Subjects were assess as complete response, partial response, stable disease, and progressive disease after 2 cycles (6 weeks) of beginning treatment and every 6 weeks afterward until progression of disease, unacceptable toxicity, or subject withdrawl from study.
the measurement reported is the number of patients who met the criteria for partial response."|Subjects treated until progression of disease or unacceptable toxicity. no maximum dose was specified|All subjects who underwent treatment and participated in the study were analysed||participants|||Number
796325|NCT00928642|Primary|To Determine the Safety and Tolerability Via Frequency and Severity of Adverse Effect of Combination Gleevec and Gemzar in This Cohort of Patients as Assessed Byt Common Toxicity Criteria|Toxicity was assess prior to each cycle of therapy (every 3 weeks) and graded based on NCI common toxicity criteria|Until disease progression or unacceptable toxicity|||participants|||Number
796326|NCT00928642|Primary|The Cystostatic, Anti-tumor Activity of the Combination of Gleevec and Gemzar Via Progression-free Survival for at Least Six Months in Patients With Recurrent or Persistent Epithelial Ovarian or Primary Peritoneal Carcinoma.|Progression free survival at six months was assessed for all research subjects. Progression defined by SWOG criteria: Invest New Drugs. 1992 Nov;10(4):239-53. Progression is defined as > 50% increase in the sume of measured cross sectional area of areasa of measurable disease, measured from the lowest measured amount of disease. Progression is also defined as new areas of measurabe disease.|Time to progression was measured from enrollment in study until documented disease progression over a period not greater than 2 years.|of 8 enrolled subjects, 7 were eligible for analysis of progression-free survival at 8 months. One subject declined to continue treatment||participants|||Number
796327|NCT00928668|Secondary|Laboratory Testing: Average Change From Baseline of Potassium and Calcium|Laboratory testing: Average change from baseline of potassium and calcium measured on test-days|Baseline to Visit 6|All patients in the Safety set who have a baseline value and post dose values for each planned time.||mmol/L||Inter-Quartile Range|Geometric Mean
796328|NCT00928668|Secondary|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG|Clinical relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsenings of baseline conditions were reported as Adverse Events (cardiac disorders and investigations).|5 days|The safety set included all patients who received any study medication.||percentage of participants|||Number
796329|NCT00928668|Secondary|Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 32 Hours|Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 32 hours|32 hours post dose|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and post-dose data for at least two periods for the same endpoint.||Log base 2 (mg/ml)||Standard Error|Least Squares Mean
796330|NCT00928668|Secondary|Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 8 Hours|Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 8 hours|8 hours post dose|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and post-dose data for at least two periods for the same endpoint.||Log base 2 (mg/ml)||Standard Error|Least Squares Mean
796333|NCT00928668|Primary|Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 24 Hours|Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 24 hours|24 hours post dose|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and post-dose data for at least two periods for the same endpoint.||Log base 2 (mg/ml)||Standard Error|Least Squares Mean
796334|NCT00928694|Primary|Maximum Plasma Concentration (Cmax) of Fenofibric Acid||Predose and up to 168 hours postdose|Healthy Male and Female subjects Aged 18 to 45||μg/mL||Standard Deviation|Least Squares Mean
796335|NCT00928694|Primary|Area Under the Curve (AUC(0 to Infinity)) of Fenofibric Acid||Predose and up to 168 hours postdose|Healthy Male and Female subjects Aged 18 to 45||μg·hr/mL||Standard Deviation|Least Squares Mean
796336|NCT00928720|Secondary|Differences in Brain Activity in Pain Processing Regions Between the Active CES and Sham Device Groups in a Subset of 12 Participants (6 in Each Device Group) Using fMRI||at baseline and week 8||||||
796337|NCT00928720|Secondary|Blood Pressure Using the Omron HEM-711DLX Upper Arm Blood Pressure Monitor||at baseline and daily over 8 weeks||||||
796338|NCT00928720|Secondary|Functional Status Using the Fibromyalgia Index Questionnaire||at baseline and weekly over 8 weeks||||||
796339|NCT00928720|Secondary|Perceived Stress Using Numeric Rating Scale and the Daily Stress Inventory||at baseline and weekly over 8 weeks||||||
796340|NCT00928720|Secondary|Depression Using the CES-D||at baseline and weekly over 8 weeks||||||
796341|NCT00928720|Secondary|Sleep Disturbances and Sleep Quality Using Wrist Actigraph and Sleep Diary, General Sleep Disturbance Scale, and Pittsburgh Sleep Quality Index||wear actigraph and keep sleep diary for 96 hrs at baseline and weeks 4 and 8; GSDS at baseline and weekly over 8 weeks; PSQI at baseline and weeks 4 and 8||||||
796342|NCT00928720|Secondary|Fatigue Using Lee's Fatigue Scale|A Numeric Rating Scale ranging from 0-10 to capture present levels of fatigue using the fatigue subscale of Lee's Fatigue Scale|at baseline and weekly over 8 weeks||||||
796343|NCT00928720|Primary|Pain Intensity Using Numeric Rating Scale|A Numeric Rating Scale ranging from 0 (no pain) to 10 (worst pain imaginable) to capture present pain intensity|week 8|||units on a scale||Standard Deviation|Mean
796344|NCT00928746|Secondary|Number of Participants Having Any Additional Comments According to Patient Handling Questionnaire||21 Days|This secondary analysis was performed using the Full Analysis Set (FAS).||participants|||Number
796345|NCT00928746|Secondary|Number of Participants Who Reported Satisfaction With Dose Counter in the Mouthpiece of the Inhaler According to Patient Handling Questionnaire||21 Days|This secondary analysis was performed using the Full Analysis Set (FAS).||participants|||Number
796346|NCT00928746|Secondary|Number of Participants Who Reported Satisfaction With Ease of Use of the Dose Counter According to Patient Handling Questionnaire||21 Days|This secondary analysis was performed using the Full Analysis Set (FAS).||participants|||Number
796347|NCT00928746|Secondary|Number of Participants Who Reported Satisfaction That the Dose Counter Worked Reliably According to Patient Handling Questionnaire||21 Days|This secondary analysis was performed using the Full Analysis Set (FAS).||participants|||Number
796348|NCT00928746|Secondary|Number of Participants Who Reported Satisfaction With Performance of the Dose Counter for Indicating Approximately How Many Doses Remain in Inhaler According to Patient Handling Questionnaire||21 Days|This secondary analysis was performed using the Full Analysis Set (FAS).||participants|||Number
796349|NCT00928746|Secondary|Number of Participants Who Reported Problems With Inhaler and Dose Counter Performing as Expected Based on Instructions According to Patient Handling Questionnaire||21 Days|This secondary analysis was performed using the Full Analysis Set (FAS).||participants|||Number
796350|NCT00928746|Secondary|Number of Participants Who Reported Problems With Seeing Red Warning Indicating Inhaler Near End of Recommended Doses According to Patient Handling Questionnaire||21 Days|This secondary analysis was performed using the Full Analysis Set (FAS).||participants|||Number
796351|NCT00928746|Secondary|Number of Participants Who Reported Problems With Use of Inhaler With Integrated Dose Counter According to Patient Handling Questionnaire||21 Days|This secondary analysis was performed using the Full Analysis Set (FAS).||participants|||Number
796352|NCT00928746|Secondary|Difference Between the Number of Actuations Registered by the Actuation Indicator and Read by Site Coordinator Versus Actuations Dispensed||21 Days|This secondary analysis was performed using the Full Analysis Set (FAS).||Count||95% Confidence Interval|Median
796353|NCT00928746|Secondary|Difference Between the Number of Actuations Based on Advancing Actuation Indicator Versus Actuations Dispensed|Difference between the number of actuations based on advancing the actuation indicator to a zero reading or to the next increment and the number of actuations dispensed (calculated using weight differential and shot weight)|21 Days|This secondary analysis was performed using the Full Analysis Set (FAS).||Count||95% Confidence Interval|Median
796354|NCT00928746|Secondary|Difference Between the Number of Actuations Recorded on Patient Diary Versus Actuations Dispensed|Difference between the number of actuations recorded on patient diary and the number of actuations dispensed (calculated using weight differential and shot weight)|21 Days|This secondary analysis was performed using the Full Analysis Set (FAS).||Count||95% Confidence Interval|Median
796355|NCT00928746|Secondary|Actuations Registered by the Actuation Indicator and Read by Site Coordinator||21 Days|This secondary analysis was performed using the Full Analysis Set (FAS).||Count||Standard Deviation|Median
796356|NCT00928746|Secondary|Actuations Based on Advancing the Actuation Indicator|Actuations based on advancing the actuation indicator to a zero reading or to the next increment|21 Days|This secondary analysis was performed using the Full Analysis Set (FAS).||Count||Standard Deviation|Median
796357|NCT00928746|Secondary|Actuations Recorded on Patient Diary||21 Days|This secondary analysis was performed using the Full Analysis Set (FAS).||Count||Standard Deviation|Median
796358|NCT00928746|Primary|Difference Between the Number of Actuations Registered by Actuation Indicator Versus Actuations Dispensed|Difference between the number of actuations registered by the actuation indicator and the number of actuations dispensed (calculated using weight differential and shot weight)|21 Days|The primary analysis was performed using the Full Analysis Set (FAS)||Count||95% Confidence Interval|Median
796793|NCT00934180|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
796360|NCT00928746|Primary|Actuations Registered by the Actuation Indicator|This outcome measure presents the number of actuations (doses) of medication used in the specific time frame as measured by the actuation indicator|21 Days|The primary analysis was performed using the Full Analysis Set (FAS).||Count||Standard Deviation|Median
796361|NCT00928772|Secondary|Heart Rate During Cataract Surgery Under Topical Anesthesia||during cataract surgery up to 30 minutes|||Beats per minute||Full Range|Mean
796362|NCT00928772|Secondary|Mean Arterial Pressure During the Cataract Surgery Under Topical Anesthesia||during cataract surgery up to 30 minutes|||mmHg||Full Range|Mean
796363|NCT00928772|Secondary|Eye Discomfort Perception During Cataract Surgery Under Topical Anesthesia|VAS from 0 to 10 with 10 being maximal discomfort percieved|during cataract surgery up to 30 minutes|||units on a scale||Full Range|Mean
796364|NCT00928772|Primary|Anxiety During Cataract Surgery Under Topical Anesthesia|Anxiety was accessed via VAS from 0 to 10 with 10 being the most anxious.|during the cataract surgery up to30 minutes|||units on a scale||Full Range|Mean
796365|NCT00928889|Secondary|Change From Baseline in Glycosylated Serum Albumin (GSA) at the End of the Study (Week 4)|Blood samples were collected for measurement of GSA prior to (fasting) the start of a standardized meal test at Baseline and Week 4. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM. GSA was assayed at a central laboratory.|Baseline to the end of the study (Week 4)|Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable.||Percentage||Standard Deviation|Mean
796366|NCT00928889|Secondary|Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) at the End of the Study (Week 4)|Blood samples were collected for measurement of hsCRP prior to (fasting) and 30, 60, 90, and 120 minutes following the start of a standardized meal test at Baseline and Week 4. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM. hsCRP was assayed at a central laboratory.|Baseline to the end of the study (Week 4)|Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable.||mg/dL||Standard Deviation|Mean
796367|NCT00928889|Secondary|Change From Baseline in Free Fatty Acids (FFA) at the End of the Study (Week 4)|Blood samples were collected for measurement of FFA prior to (fasting) and 30, 60, 90, and 120 minutes following the start of a standardized meal test at Baseline and Week 4. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM. FFA was assayed at a central laboratory.|Baseline to the end of the study (Week 4)|Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable.||mmol/L||Standard Deviation|Mean
796368|NCT00928889|Secondary|Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at the End of the Study (Week 4)|Blood samples were collected for measurement of HDL-C prior to (fasting) and 120 minutes following the start of a standardized meal test at Baseline and Week 4. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM. HDL-C was assessed at each study site using the same method and same reference value.|Baseline to the end of the study (Week 4)|Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable.||mmol/L||Standard Deviation|Mean
796369|NCT00928889|Secondary|Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at the End of the Study (Week 4)|Blood samples were collected for measurement of LDL-C prior to (fasting) and 120 minutes following the start of a standardized meal test at Baseline and Week 4. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM. LDL-C was assessed at each study site using the same method and same reference value.|Baseline to the end of the study (Week 4)|Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable.||mmol/L||Standard Deviation|Mean
796370|NCT00928889|Secondary|Change From Baseline in Triglycerides at the End of the Study (Week 4)|Blood samples were collected for measurement of triglycerides prior to (fasting) and 120 minutes following the start of a standardized meal test at Baseline and Week 4. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM. Triglycerides were assessed at each study site using the same method and same reference value.|Baseline to the end of the study (Week 4)|Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable.||mmol/L||Standard Deviation|Mean
796371|NCT00928889|Secondary|Change From Baseline in Total Cholesterol at the End of the Study (Week 4)|Blood samples were collected for measurement of total cholesterol prior to (fasting) and 120 minutes following the start of a standardized meal test at Baseline and Week 4. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM. Total cholesterol was assessed at each study site using the same method and same reference value.|Baseline to the end of the study (Week 4)|Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable.||mmol/L||Standard Deviation|Mean
796372|NCT00928889|Secondary|Change From Baseline in Postprandial Glucose Area Under the Curve at the End of the Study (Week 4)|Blood samples were collected for measurement of plasma glucose at 30, 60, 90, and 120 minutes following the start of a standardized meal test at Baseline and Week 4. The postprandial glucose area under the curve was calculated using values from the 4 time points. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM.|Baseline to the end of the study (Week 4)|Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable.||mmol*min/L||Standard Deviation|Mean
798355|NCT00939211|Secondary|Diastolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose|Average diastolic blood pressure value|0, 30 min, 2 h, 4 h|||mmHg||Standard Deviation|Mean
796373|NCT00928889|Secondary|Change From Baseline in Peak Postprandial Glucose at the End of the Study (Week 4)|Blood samples were collected for measurement of plasma glucose at 30, 60, 90, and 120 minutes following the start of a standardized meal test at Baseline and Week 4. The peak postprandial glucose values were used in the calculation of change from Baseline at Week 4. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM.|Baseline to the end of the study (Week 4)|Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable.||mmol/L||Standard Deviation|Mean
796374|NCT00928889|Primary|Change From Baseline in Postprandial Glucose Excursion (PPGE) at the End of the Study (Week 4)|Blood samples were collected for measurement of plasma glucose at 30, 60, 90, and 120 minutes following the start of a standardized meal test at Baseline and Week 4. PPGE was defined as the mean difference between the preprandial glucose value and the postprandial glucose value measured at 2 hours in a standardized meal test. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM.|Baseline to the end of the study (Week 4)|Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable.||mmol/L||Standard Deviation|Mean
796375|NCT00928954|Primary|Percent Change in Median Eye Speed|Median eye speed during attempted visual fixation by each eye|After 2 weeks of therapy, for both drugs|||Percent change|||Number
796376|NCT00928954|Primary|Change in logMAR Visual Acuity of Each Eye, Measured During Far or Near Viewing||After 2 weeks of therapy, for both drugs|||logMAR|||Number
796377|NCT00929071|Primary|Assessment of Immediate Post-injection Pain Severity by Investigator|Investigators assessment of immediate post-injection pain severity using Thermometer Pain Scale (TPS) with a range of 0-10 where 0=no pain and 10=worst possible pain|immediate post injection|||units on a scale|Participants|Standard Deviation|Mean
796378|NCT00929071|Primary|Assessment of Immediate Post-injection Pain Severity by Subject|Subjects assessment of immediate post-injection pain severity using a visual analogue scale (VAS) 100 mm in length, ranging from no pain (0) to unbearable pain (100).|immediate post-injection|||units on a scale|Participants|Standard Deviation|Mean
796379|NCT00929110|Secondary|Change From Baseline in the Mean Daily Total Symptom Score During the Study (Baseline to Week 52)|The daily total symptom score was defined as the sum of the morning and evening patient self-reported diary assessments of 6 symptoms (respiratory symptoms/impact on daily activities, cough, wheeze, amount of sputum, color of sputum, and breathlessness). Means for baseline (14 day maximum run-in period) and the 52 week treatment period were calculated. Mean scores ranged from 0-18, with a higher score indicating worse symptoms. A negative change score indicated improvement.|Baseline to Week 52|Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.||Units on a scale||Standard Error|Least Squares Mean
796380|NCT00929110|Secondary|Percentage of “Days Able to Perform Usual Daily Activities” During the Study (Baseline to Week 52)|A “day able to perform usual daily activities” was defined as any day where the patient recorded in their electronic diary in the evening that they were not prevented from performing their usual daily activities due to respiratory symptoms during the previous 12 hours. The percentage of “days able to perform usual daily activities” was calculated as the total number of “days able to perform usual daily activities” over the 52 week treatment period divided by the total number of days where diary recordings were made.|Baseline to Week 52|Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.||Percentage of days||Standard Error|Least Squares Mean
796381|NCT00929110|Secondary|Percentage of Days With “no Daytime Symptoms” During the Study (Baseline to Week 52)|A day with “no daytime symptoms” was defined as any day where the patient recorded no cough, no wheeze, no production of sputum, no feeling of breathlessness (other than when running), and no puffs of rescue medication during the previous 12 hours in evening entry in the electronic patient diary. The percentage of days with “no daytime symptoms” was calculated as the total number of days with “no daytime symptoms” over the 52 week treatment period divided by the total number of days where diary recordings were made.|Baseline to Week 52|Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.||Percentage of days||Standard Error|Least Squares Mean
796382|NCT00929110|Secondary|Percentage of Nights With “no Nighttime Awakenings” During the Study (Baseline to Week 52)|A night with “no nighttime awakenings” was defined as any night where the patient did not wake up due to 1 or more of 6 symptoms (respiratory symptoms, cough, wheeze, amount of sputum, color of sputum, and breathlessness). Symptoms occurring during the previous 12 hours were recorded each morning and evening by the patient in an electronic diary. The percentage of nights with ‘no nighttime awakenings’ was calculated as the total number of nights with “no nighttime awakenings” over the 52 week treatment period divided by the total number of nights where diary recordings were made.|Baseline to Week 52|Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.||Percentage of nights||Standard Error|Least Squares Mean
796383|NCT00929110|Secondary|Percentage of Patients Who Experienced a Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation During the Study (Baseline to Week 52)|A COPD exacerbation was considered to be moderate if treatment with systemic corticosteroids and/or antibiotic was required. A COPD exacerbation was considered to be severe if treatment for moderate severity and hospitalization was required.|Baseline to Week 52|Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.||Percentage of participants|||Number
796384|NCT00929110|Secondary|Number of Moderate or Severe Exacerbations of Chronic Obstructive Pulmonary Disease (COPD) Per Year During the Study (Baseline to Week 52)|The number of moderate or severe exacerbations of COPD per year during the study was calculated by dividing the total number of exacerbations during the study by the total number of years of treatment. A COPD exacerbation was considered to be moderate if treatment with systemic corticosteroids and/or antibiotic was required. A COPD exacerbation was considered to be severe if treatment for moderate severity and hospitalization was required.|Baseline to Week 52|Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.||Exacerbations per treatment year||95% Confidence Interval|Number
797650|NCT00943111|Secondary|Hemoglobin Level||Baseline|Per protocol population for PAP. Number of participants analyzed = participants with baseline hemoglobin assessment.||gram per deciliter (g/dL)||Standard Deviation|Mean
796385|NCT00929110|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 23 Hours 45 Minutes and From 12 Hours to 23 Hours 45 Minutes Post-dose at Weeks 12 and 52|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5, 15, and 30 minutes; 1, 2, 3, 4, 6, 8, 10, and 12 hours; 23 hours 15 minutes; and 23 hours 45 minutes post-dose. Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included the same covariates as the primary Outcome Measure.|From 5 minutes to 23 hours 45 minutes post-dose at Weeks 12 and 52|Full Analysis Set (FAS), serial spirometry subgroup: A subgroup of approximately one third of all randomized patients who received at least 1 dose of study medication.||Liters||Standard Error|Least Squares Mean
796386|NCT00929110|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 12 Hours Post-dose at Day 1 and Weeks 12 and 52|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5, 15, and 30 minutes; and 1, 2, 3, 4, 6, 8 10, and 12 hours post-dose. Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included the same covariates as the primary Outcome Measure.|From 5 minutes to 12 hours post-dose at Day 1 and Weeks 12 and 52|Full Analysis Set (FAS), serial spirometry subgroup: A subgroup of approximately one third of all randomized patients who received at least 1 dose of study medication.||Liters||Standard Error|Least Squares Mean
796387|NCT00929110|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose at Day 1 and Weeks 12, 26, and 52|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5, 15, and 30 minutes; and 1, 2, 3, and 4 hours post-dose. Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included the same covariates as the primary Outcome Measure.|From 5 minutes to 4 hours post-dose at Day 1 and Weeks 12, 26, and 52|Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.||Liters||Standard Error|Least Squares Mean
796388|NCT00929110|Secondary|Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52|Just prior to FVC measurement, patients performed normal tidal breathing. The patient was given a few breaths warning before being told “At the end of the next normal breath out, take a deep breath all the way in”; they were then verbally encouraged to make a maximal effort before relaxing. The analysis included the same covariates as the primary Outcome Measure. Data was not collected at all time points for all Days and Weeks.|5, 15, and 30 minutes; and 1, 2, 3, 4 hours post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52|Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.||Liters||Standard Error|Least Squares Mean
796389|NCT00929110|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included the same covariates as the primary Outcome Measure. Data was not collected at all time points for all Days and Weeks.|5, 15, and 30 minutes; and 1, 2, 3, 4 hours post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52|Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.||Liters||Standard Error|Least Squares Mean
796390|NCT00929110|Secondary|Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52|Just prior to FVC measurement, patients performed normal tidal breathing. The patient was given a few breaths warning before being told “At the end of the next normal breath out, take a deep breath all the way in”; they were then verbally encouraged to make a maximal effort before relaxing. The analysis included the same covariates as the primary Outcome Measure. Data was not collected at all time points for all Days and Weeks.|5, 15, and 30 minutes; 1, 2, 3, 4, 6, 8, 10, and 12 hours; 23 hours 15 minutes; and 23 hours 45 minutes post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52|Full Analysis Set (FAS), serial spirometry subgroup: A subgroup of approximately one third of all randomized patients who received at least 1 dose of study medication.||Liters||Standard Error|Least Squares Mean
796391|NCT00929110|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included the same covariates as the primary Outcome Measure. Data was not collected at all time points for all Days and Weeks.|5, 15, and 30 minutes; 1, 2, 3, 4, 6, 8, 10, and 12 hours; 23 hours 15 minutes; and 23 hours 45 minutes post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52|Full Analysis Set (FAS), serial spirometry subgroup: A subgroup of approximately one third of all randomized patients who received at least 1 dose of study medication.||Liters||Standard Error|Least Squares Mean
796392|NCT00929110|Secondary|Trough Forced Vital Capacity (FVC) at Day 1, Week 12, Week 26, and Week 52|Trough FVC is defined as the average of the post-dose 23 h 15 min and the 23 h 45 min FVC values. Just prior to FVC measurement, patients performed normal tidal breathing. The patient was given a few breaths warning before being told “At the end of the next normal breath out, take a deep breath all the way in”; they were then verbally encouraged to make a maximal effort before relaxing. The analysis included the same covariates as the primary Outcome Measure.|Day 1, Week 12, Week 26, and Week 52|Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.||Liters||Standard Error|Least Squares Mean
796393|NCT00929110|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 1, Week 26, and Week 52|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 15 minutes and 23 hours 45 minutes post-dose. The analysis included the same covariates as the primary Outcome Measure.|Day 1, Week 26, and Week 52|Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.||Liters||Standard Error|Least Squares Mean
796521|NCT00929734|Primary|Relative Change in Reactive Hyperemia Index (RHI)|Endothelial function assessed with peripheral arterial tonometry, expressed as the reactive hyperemia index (RHI) as a marker for subclinical atherosclerosis and future cardiovascular risk assessment.|Baseline to 3 months|Complete case analysis||percent change||95% Confidence Interval|Mean
796394|NCT00929110|Secondary|Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication Taken During the Study (Baseline to Week 52)|The number of puffs of rescue medication taken in the previous 12 hours was recorded in the Patient Diary in the morning and evening. The mean daily number of puffs of rescue medication taken was calculated by dividing the number of puffs of rescue medication per day over the 52 weeks of the study by the number of days with non-missing rescue medication data. Rescue medication data recorded during the 14 day run-in period was used to calculate the baseline. The analysis included the same covariates as the primary Outcome Measure. A positive change score indicates more puffs taken.|Baseline to Week 52|Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.||Puffs||Standard Error|Least Squares Mean
796395|NCT00929110|Secondary|Time to First Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation During the Study (Baseline to Week 52)|Time to first moderate or severe COPD exacerbation was calculated as the number of days from baseline to the day on which the patient experienced the first moderate or severe COPD exacerbation. A COPD exacerbation was considered to be moderate if treatment with systemic corticosteroids and/or antibiotic was required. A COPD exacerbation was considered to be severe if treatment for moderate severity and hospitalization was required.|Baseline to Week 52 (patients with no moderate or severe exacerbations who completed the study were censored at the final visit date, which may have exceeded 52 weeks)|Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.||Days||Full Range|Median
796396|NCT00929110|Secondary|Health-related Quality of Life (QoL) Assessed With the St. George Respiratory Questionnaire (SGRQ) at Week 52|The SGRQ contained 51 patient-rated items divided into three components: Symptoms (respiratory symptoms, their frequency, and severity), Activity (activities that cause or are limited by breathlessness), and Impacts (social functioning and psychological disturbances resulting from airway disease). A total score for the 3 components was calculated and ranged from 0 to 100. Higher values indicate greater impairment of QoL. The analysis included the same covariates as the primary Outcome Measure.|Week 52|Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.||Units on a scale||Standard Error|Least Squares Mean
796397|NCT00929110|Secondary|Transition Dyspnea Index (TDI) at Week 26|The TDI measured changes in dyspnea from baseline during treatment and included 3 domains: Functional impairment (activities of daily living), magnitude of task (intensity of activity), and magnitude of effort (difficulty breathing). Each domain was rated from -3 to 3 (major deterioration-major improvement). The total score ranged from -9 to 9; minus scores indicate deterioration. The analysis included the same covariates as the primary Outcome Measure.|Week 26|Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.||Units on a scale||Standard Error|Least Squares Mean
796398|NCT00929110|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 15 minutes and 23 hours 45 minutes post-dose. The analysis included baseline FEV1 measurement, baseline inhaled corticosteroid use (Yes/No), FEV1 prior to inhalation of short-acting β2 agonist (SABA), and FEV1 45 min post-inhalation of SABA as covariates.|Week 12|Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.||Liters||Standard Error|Least Squares Mean
796399|NCT00929162|Secondary|Tumour Response Rate|Objective response rate defined as participants with a complete or partial response according to RECIST|While receiving paclitaxel + carboplatin study visits were aliged with its administration ie every 3 weeks, then every 6 weeks (up to 2 years)|The number of participants for analysis corresponds to patients with measurable disease at study entry||Participants|||Number
796400|NCT00929162|Secondary|Overall Survival|Median time (in months) from randomisation until death using the Kaplan-Meier method.|Patients were followed for survival up to 2 years|Overall Survival was not analysed as the study was terminated early.|||||
796401|NCT00929162|Primary|Progression Free Survival|Median time (in months) from randomisation until clinical progression of disease using the Kaplan-Meier method.|Patients were followed for progression up to 2 years|||Months||Inter-Quartile Range|Median
796402|NCT00929201|Secondary|Peak Plasma Concentration (Cmax) of Metformin|Serum samples were used to determine the maximum concentration for metformin.|Predose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 32, 48, and 72 hours postdose|All participants who completed and who had pharmacokinetic data available from at least one treatment period||ng/mL||Standard Deviation|Least Squares Mean
796403|NCT00929201|Primary|Plasma Area Under the Curve (AUC(0 to Infinity)) for Metformin|Serum samples were used to determine the AUC from time 0 to infinity for metformin.|Predose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 32, 48, and 72 hours postdose|All participants who completed and who had pharmacokinetic data available from at least one treatment period||μg * hr/mL||Standard Deviation|Least Squares Mean
796404|NCT00929240|Secondary|Percentage of Participants With Clinical Benefit (CR, PR and SD) Per RECIST 1.0 (Initial Treatment Phase)|CR was defined as complete disappearance of all target and non-target lesions and no new lesions. PR was defined as ≥30% decrease in the sum of appropriate diameters of all target measurable lesions, no progress in the non-measurable disease, and no new lesions. SD was defined as small changes that do not meet above criteria.|Screening and at the end of every third cycle until randomization for an average of 18 weeks|Initial Phase ITT population; only participants who were not randomized at the end of the initial treatment phase were included in this analysis.||percentage of participants||95% Confidence Interval|Number
796405|NCT00929240|Secondary|Percentage of Participants With Best Overall Confirmed Objective Response of CR or PR Per RECIST 1.0 (Initial Treatment Phase)|Objective Response was determined by the investigator using RECIST criteria, Version 1.0. An objective response was a complete or partial overall confirmed response as determined by investigators. CR was defined as complete disappearance of all target and non-target lesions and no new lesions. PR was defined as ≥ 30% decrease in the sum of appropriate diameters of all target measurable lesions, no progress in the non-measurable disease, and no new lesions. Pearson-Clopper one-sample method was used for CI.|Screening and at the end of every third cycle until randomization for an average of 18 weeks|Initial Phase ITT population; only participants who were not randomized at the end of the initial treatment phase were included in this analysis.||percentage of participants||95% Confidence Interval|Number
796908|NCT00935532|Secondary|Change in Blood Pressure From Baseline to Endpoint (Week 26)|Change in Blood Pressure from baseline to endpoint (Week 26)|Baseline, Week 26|FAS Population. Missing data at endpoint was imputed using LOCF approach.||mmHg||Standard Deviation|Mean
796406|NCT00929240|Secondary|Quality of Life Assessed As Change From Baseline in Global Health Status Using The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - 30 (EORTC QLQ - C30) (Maintenance Phase Data Cutoff October 4, 2013)|The EORTC QLQ-C30 incorporates 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social); 9 symptom scales (fatigue, pain, nausea and vomiting, dyspnoea, insomnia, appetite loss, constipation, diarrhea and financial difficulties); and a global health and quality-of-life scale. Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores were averaged and transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms. The change in global health status was determined to be the difference in values at baseline and each specific visit. The term ‘’baseline’’ refers to the time of randomization to the maintenance phase.|Baseline, Randomization and Cycles 3, 6, 9 and 12|Maintenance Phase ITT population; n (number) = number of participants analyzed at the specific visit. Only timepoints with more than 10 participants in each treatment arm are presented.||units on a scale||95% Confidence Interval|Mean
796407|NCT00929240|Secondary|Time To Progression (Maintenance Phase Data Cutoff October 4, 2013)|Time to Progression was defined as the time from randomization to the first documented disease progression (using investigator assessments of disease progression by RECIST 1.0). PD was defined as 20% increase in the sum of the longest diameter of target lesions.|Randomization, at the end of every third cycle (every 9 weeks) until the end of maintenance phase and every 3 months until disease progression or death until data cutoff on October 4, 2013|Maintenance Phase ITT population||months||95% Confidence Interval|Median
796408|NCT00929240|Secondary|Percentage Of Participants With PD or Death Due to PD (Maintenance Phase Data Cutoff October 4, 2013)|PD was defined per RECIST 1.0 as 20% increase in the sum of the longest diameter of target lesions.|Randomization, at the end of every third cycle (every 9 weeks) until the end of maintenance phase and every 3 months until disease progression or death until data cutoff on October 4, 2013|Maintenance Phase ITT population||percentage of participants|||Number
796409|NCT00929240|Secondary|Percentage of Participants Expected to Be Alive After 1 and 2 Years on Treatment (Maintenance Phase Data Cutoff October 4, 2013)|Probability of being alive after 1 and 2 years on treatment with 95% CIs was calculated using Kaplan Meier approach with LOGLOG transformation.|Years 1 and 2|Maintenance Phase ITT Population||percentage of participants||95% Confidence Interval|Number
796410|NCT00929240|Secondary|Overall Survival (Maintenance Phase Data Cutoff October 4, 2013)|Duration of Overall Survival (OS) was defined as the time from randomization to death of any cause. The OS data for participants for whom no death was captured in the clinical database were censored at the last time they were known to be alive. Kaplan Meier estimation was used to determine OS.|Randomization, at the end of every third cycle (every 9 weeks) until the end of maintenance phase and every 3 months until disease progression or death until data cutoff on October 4, 2013, up to 4 years|Maintenance Phase ITT population||months||95% Confidence Interval|Median
796411|NCT00929240|Secondary|Percentage of Participants Who Died (Maintenance Phase Data Cutoff October 4, 2013)||Randomization, at the end of every third cycle (every 9 weeks) until the end of maintenance phase and every 3 months until disease progression or death until data cutoff on October 4, 2013, up to 4 years|Maintenance Phase ITT population||percentage of participants|||Number
796412|NCT00929240|Secondary|Percentage of Participants With Clinical Benefit (CR, PR and SD) Per RECIST 1.0 (Data Cutoff October 4, 2013)|CR was defined as complete disappearance of all target and non-target lesions and no new lesions. PR was defined as ≥ 30 % decrease in the sum of appropriate diameters of all target measurable lesions, no progress in the non-measurable disease, and no new lesions. SD was defined as small changes that do not meet above criteria.|Randomization, at the end of every third cycle (every 9 weeks) until the end of maintenance phase and every 3 months until disease progression or death until data cutoff on October 4, 2013, up to 4 years|Maintenance Phase ITT population||percentage of participants||95% Confidence Interval|Number
796413|NCT00929240|Secondary|Percentage of Participants With Best Overall Confirmed Objective Response of CR or PR Per RECIST 1.0 (Maintenance Phase Data Cutoff October 4, 2013)|Objective Response was determined by the investigator using modified RECIST criteria, Version 1.0. An objective response was a complete or partial overall confirmed response as determined by investigators. CR was defined as complete disappearance of all target and non-target lesions and no new lesions. PR was defined as greater than or equal to (≥) 30 % decrease in the sum of appropriate diameters of all target measurable lesions, no progress in the non-measurable disease, and no new lesions. Progressive disease (PD) was defined as 20% increase in the sum of the longest diameter of target lesions and SD was defined as small changes that do not meet above criteria. Pearson-Clopper one-sample method was used for Confidence intervals (CIs).|Randomization, at the end of every third cycle (every 9 weeks) until the end of maintenance phase and every 3 months until disease progression or death until data cutoff on October 4, 2013, up to 4 years|Maintenance Phase ITT Population||percentage of participants||95% Confidence Interval|Number
796414|NCT00929240|Primary|Progression Free Survival (Maintenance Phase Data Cutoff October 4, 2013)|PFS was defined as the time from first study drug dosing to the first documented disease progression or death, whichever occurred first.Time to progression was defined as the time from randomization to the first documented disease progression defined per RECIST 1.0 criteria. Participants without an event at data cut-off or who were withdrawn from the study without documented progression were censored at the date of the last tumor assessment when the participant was known to be progression free. Participants who took other non-protocol anti-cancer drugs while being on study medication, and who were still event free were censored on the date of first dose of the anti-cancer drug. Participants without post-randomization tumor assessments but alive were censored at the time of randomization. Participants without post-randomization assessments, who died after randomization were considered to have the PFS event at date of death. Kaplan-Meier estimation was used for median time to PFS|Randomization, at the end of every third cycle (every 9 weeks) until the end of maintenance phase and every 3 months until disease progression or death until data cutoff on October 4, 2013, up to 4 years|Maintenance Phase ITT population||months||95% Confidence Interval|Median
796469|NCT00929526|Secondary|Number of Subjects With New Onset of Autoimmune Diseases (NOADs) Regardless of Causal Relationship to Vaccination and Intensity.||During the follow-up period from last study visit at Month 24 in the primary vaccination study NCT00316693 until the end of this follow-up study at Month 12|The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available.||Subjects|||Number
796415|NCT00929240|Primary|Percentage of Participants With Disease Progression or Death (Maintenance Phase Data Cutoff October 4, 2013)|Progression Free Survival (PFS) was defined as the time from first study drug dosing (during the maintenance treatment phase) to the first documented disease progression or death, whichever occurred first. Progression was based on tumor assessment made by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST). Progressive Disease (PD) was defined as a 20 percent (%) or greater increase in the sum of the Longest Diameter (LD) of the target lesions taking as reference the smallest sum LD recorded or appearance of new lesions.|Randomization, at the end of every third cycle (every 9 weeks) until the end of maintenance phase and every 3 months until disease progression or death until data cutoff on October 4, 2013, up to 4 years|Maintenance Phase ITT population: All randomized participants||percentage of participants|||Number
796416|NCT00929305|Primary|Change in Self-reported Pain Rating in the Neck and Shoulder Area on the 0-100 Visual Analog Scale (VAS)From Baseline to One Day Post-treatment|Participants self-rated the degree of pain experienced in the neck-shoulder region on the 0-100 standardized Visual Analog Scale (VAS) at baseline and one day post-treatment. The VAS is a 100mm long horizontal scale ranging from '0: no pain at all' on one end to '100: worst pain imaginable' on the other end. The participant marked the point along the scale that best showed the pain level they experienced in the neck-shoulder area at that point in time. The higher the number marked, the greater the pain level.|baseline and one day|||units on a scale||Standard Deviation|Mean
796417|NCT00929305|Secondary|Muscle Trigger Points of the Cervical Spine||one day||||||
796418|NCT00929305|Secondary|Range of Motion of the Neck and Shoulders||one day||||||
796419|NCT00929305|Primary|The Number of Participants Whose Self-reported Pain Rating in the Neck and Shoulder Area on the 0-100 Visual Analog Scale (VAS) Decreased by 30% or More From Baseline to One Day After Study Treatment|Participants self-rated the degree of pain experienced in the neck-shoulder region on the 0-100 standardized Visual Analog Scale (VAS) at baseline and one day post-treatment. The VAS is a 100mm long horizontal scale ranging from '0: no pain at all' on one end to '100: worst pain imaginable' on the other end. The participant marked the point along the scale that best showed the pain level they experienced in the neck-shoulder area at each point in time. The higher the number marked, the greater the pain level.|baseline and one day|||participants|||Number
796420|NCT00929331|Secondary|Number of Subjects With Serious Adverse Events|SAEs assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From the beginning up to the end of the study (Day 0 - Day 21)|||subjects|||Number
796421|NCT00929331|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|"Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Any = unsolicited adverse event regardless of intensity. Grade 3 = unsolicited AE that prevented normal activity Related = unsolicited AE assessed by the investigator as related to the vaccination."|During a 21-day (Day 0-20) follow-up period after vaccination|Analysis was performed on the Total Vaccinated Cohort, which included all subjects for whom data were available.||subjects|||Number
796422|NCT00929331|Secondary|Number of Subjects Reporting Related Solicited General Symptoms|"Solicited local symptoms assessed include bronchospasm, chills, cough, fatigue, headache, joint pain at other location, muscle aches, red eyes, sore throat, swelling of the face, temperature (orally) in degrees celsius.
Related = general symptom assessed by the investigator as related to the vaccine"|During a 4-day (Day 0-3) follow-up period after vaccination|Analysis was performed on the Total Vaccinated Cohort, which included all subjects for whom data were available.||subjects|||Number
796423|NCT00929331|Secondary|Number of Subjects Reporting Grade 3 Solicited General Symptoms|"Solicited local symptoms assessed include bronchospasm, chills, cough, fatigue, headache, joint pain at other location, muscle aches, red eyes, sore throat, swelling of the face, temperature (orally) in degrees celsius.
Grade 3 general symptom = symptom that prevented normal activity Grade 3 temperature = temperature above 39.0 degrees celsius"|During a 4-day (Day 0-3) follow-up period after vaccination|Analysis was performed on the Total Vaccinated Cohort, which included all subjects for whom data were available.||subjects|||Number
796424|NCT00929331|Primary|Number of Subjects With a Pre-vaccination Titer Below the Cut-off Value and a Post-vaccination Titer Equal to or Above the Cut-off Value|"The cut-off value was a titer of 1:40.
Data are displayed for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane."|At Day 21 after vaccination|Analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. These included subjects for whom assay results were available for antibodies against at least on study vaccine antigen component after vaccination.||subjects|||Number
796425|NCT00929331|Primary|Seroconversion Factors|"Seroconversion factors are defined as the fold increase in serum HI GMTs post-vaccination (Day 21) compared to pre-vaccination (Day 0).
Data are displayed for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane."|At Day 21 after vaccination|Analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. These included subjects for whom assay results were available for antibodies against at least on study vaccine antigen component after vaccination.||ratio||95% Confidence Interval|Mean
796426|NCT00929331|Primary|Number of Seroconverted Subjects|"A seroconverted subject is a subject who had either a prevaccination titer < 1:10 and a post-vaccination titer >= 1:40 or a pre-vaccination titer >= 1:10 and at least a four-fold increase in post-vaccination titer.
Data are displayed for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane."|At Day 21 after vaccination|Analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. These included subjects for whom assay results were available for antibodies against at least on study vaccine antigen component after vaccination.||subjects|||Number
796497|NCT00929695|Secondary|Overall Survival|Percentage of patients surviving as estimated by Kaplan-Meier.|At 12 months after the start of prednisone therapy|||percentage of participants|||Number
796498|NCT00929695|Secondary|Chronic Extensive GVHD|Percentage of patients with chronic extensive GVHD, estimated by cumulative incidence methods|At 12 months after the start of prednisone therapy|||percentage of participants|||Number
796427|NCT00929331|Primary|Number of Subjects With a Serum HI Titer Equal to or Above the Cut-off Value|"The cut-off value was defined as a serum HI titer >= 1:40, which is usually accepted as indicating protection.
Data are displayed for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane."|At Day 21 after vaccination|Analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. These included subjects for whom assay results were available for antibodies against at least on study vaccine antigen component after vaccination.||subjects|||Number
796428|NCT00929331|Primary|Number of Subjects With a Serum HI Titer Equal to or Above the Cut-off Value|"The cut-off value was defined as a serum HI titer >= 1:40, which is usually accepted as indicating protection.
Data are displayed for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane."|At Day 0|Analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. These included subjects for whom assay results were available for antibodies against at least on study vaccine antigen component after vaccination.||subjects|||Number
796429|NCT00929331|Primary|GMTs of HI Antibodies|Data are displayed as GMTs for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane.|At Day 21 after vaccination|Analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. These included subjects for whom assay results were available for antibodies against at least on study vaccine antigen component after vaccination.||titer||95% Confidence Interval|Geometric Mean
796430|NCT00929331|Secondary|Number of Subjects Reporting Any Solicited General Symptoms|"Solicited local symptoms assessed include bronchospasm, chills, cough, fatigue, headache, joint pain at other location, muscle aches, red eyes, sore throat, swelling of the face, temperature (orally) in degrees celsius.
Any = solicited general symptoms are presented regardless of their intensity grade or relationship to vaccination.
For temperature this means equal to or above 38.0 degrees celsius."|During a 4-day (Day 0-3) follow-up period after vaccination|Analysis was performed on the Total Vaccinated Cohort, which included all subjects for whom data were available.||subjects|||Number
796431|NCT00929331|Secondary|Number of Subjects Reporting Grade 3 Solicited Local Symptoms|"Solicited local symptoms assessed include pain, redness and swelling at the site of injection.
Grade 3 pain = pain that prevented normal activity, Grade 3 redness/swelling = redness/swelling > 100 mm"|During a 4-day (Day 0-3) follow-up period after vaccination|Analysis was performed on the Total Vaccinated Cohort, which included all subjects for whom data were available.||subjects|||Number
796432|NCT00929331|Secondary|Number of Subjects Reporting Any Solicited Local Symptoms|"Solicited local symptoms assessed include pain, redness and swelling at the site of injection.
Any = Solicited local symptoms are presented regardless of their intensity grade"|During a 4-day (Day 0-3) follow-up period after vaccination|Analysis was performed on the Total Vaccinated Cohort, which included all subjects for whom data were available.||subjects|||Number
796433|NCT00929331|Primary|Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies|Data are displayed as GMTs for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane.|At Day 0|Analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. These included subjects for whom assay results were available for antibodies against at least on study vaccine antigen component after vaccination.||titer||95% Confidence Interval|Geometric Mean
796434|NCT00929344|Primary|Change From Baseline in Drinking Quantity and Frequency Using Drinks Per Drinking Day at Week 12|Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. A drinking day is a day where any alcohol is consumed. Change = (Week 12 - Baseline). More negative values indicate less use of alcohol.|Baseline and Week 12|||drinks/drinking day||Standard Deviation|Mean
796435|NCT00929344|Primary|Change From Baseline in Drinking Quantity and Frequency Using Drinking Days Per Week at Week 12|Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. A drinking day is a day where any alcohol is consumed. Change = (Week 12 - Baseline). More negative values indicate less use of alcohol.|Baseline and Week 12|||drinking days/week||Standard Deviation|Mean
796436|NCT00929344|Primary|Change From Baseline in Drinking Quantity and Frequency Using Drinks Per Week at Week 12|Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. Change = (Week 12 - Baseline). More negative values indicate less use of alcohol.|Baseline and Week 12|||drinks/week||Standard Deviation|Mean
796437|NCT00929357|Secondary|Number of Participants With Laboratory Result for Cyclic Citrullinated Peptide-autoantibody-test (CCP)|Cyclic citrullinated peptide-autoantibody-test measured as Enzyme-linked immunosorbent assay (ELISA units or EU) and categorized as negative (<20 EU) or positive (≥20 up to >60 EU).|Baseline (Day 0) up to 48 months|Evaluable population; N=number of participants with evaluable data for CCP. CCP value as a laboratory diagnostic marker was collected within the complete timeframe and was documented only once; calculation for change in value not applicable.||participants|||Number
796438|NCT00929357|Secondary|Number of Participants With Change From Baseline in Rheumatoid Factor (RF)|Rheumatoid Factor measured as a titer and categorized as negative (<1:16 ratio) or positive. A ratio >1:16 indicates a higher level of RF.|Baseline (Day 0) up to 48 months|Evaluable population; (n)=number of participants with analyzable data at observation for Positive or Negative status for DMARDS and Biologics, respectively.||participants|||Number
796439|NCT00929357|Secondary|Change From Baseline in C-reactive Protein (CRP)|C-reactive protein measured as milligrams per liter (mg/l)|Baseline (Day 0) up to 48 months|Evaluable population; (n)=number of participants with analyzable data at observation for DMARDS and Biologics, respectively.||mg/l||Standard Deviation|Mean
796440|NCT00929357|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR)|Erythrocyte Sedimentation Rate measured as millimeters per hour (mm/h).|Baseline (Day 0) up to 48 months|Evaluable population; (n)=number of participants with analyzable data at observation for DMARDS and Biologics, respectively.||mm/h||Standard Deviation|Mean
796516|NCT00929708|Primary|FEV1, E24−26; the Average Value at Visit 5 Between 24 and 26 Hours Following the Morning Dose (Trough Effect)|change from baseline|24h, 26h|||Litre||Standard Deviation|Mean
796441|NCT00929357|Secondary|Change From Baseline in Disease Activity Score Based on 28 Joints (DAS 28)|DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|Baseline (Day 0) up to 48 months|Evaluable population; (n)=number of participants with analyzable data at observation for DMARDS and Biologics, respectively.||scores on a scale||Standard Deviation|Mean
796442|NCT00929357|Secondary|Number of Participants Without Erosions|Radiographic assessment of no erosions using Ratingen scoring categorized as score of 0=normal joint.|Baseline (Day 0) up to 48 months|Evaluable population. Ratingen scores were calculated based on radiographic assessment, but score of 0 (no erosions) was not reported separately; data not summarized.||participants|||Number
796443|NCT00929357|Secondary|Number of Participants Without Radiographic Progression|An increase of 4 or more points in the Ratingen score was necessary to detect a difference in radiographic progression. Ratingen score range 0 = normal joint to 5 = >80% of the joint surface are destroyed. Total possible score based on 38 joints was 0 to 190; higher scores indicated greater joint destruction. A decrease of 4 (smallest detectable difference) or more points in total Ratingen score was considered a decrease in erosive damage.|Baseline (Day 0) up to 48 months|Evaluable population||participants|||Number
796444|NCT00929357|Primary|Change From Baseline in Joint Status Assessed by Radiographic (Roentgen) Progression|Radiographic progression assessed using Ratingen score with range of 0 = normal joint; 1 = one or more erosions, <20% of the joint surface are destroyed; 2 = 21% to 40% of the joint surface are destroyed; 3 = 41% to 60% of joint surface are destroyed; 4 = 61% to 80% of the joint surface are destroyed; 5 = >80% of the joint surface are destroyed. Total possible score based on 38 joints was 0 to 190; higher scores indicated greater joint destruction. Annualized change in Ratingen score calculated as (total change in Ratingen score / time period between radiograph 1 and 2 [months])*12 months.|Baseline (Day 0) up to 48 months|Evaluable population: all participants who had provided two evaluable, consecutive radiographs of the hands and forefeet, taken at intervals of 12 to 48 months. Since the time period between the first and second radiograph could range between 12 to 48 months, changes in Ratingen score were to be normalized to 1 year.||scores on a scale||Standard Deviation|Mean
796445|NCT00929383|Secondary|Rate of Restenosis|"The rate of restenosis at 12 months was defined as the degree of residual stenosis greater than 50% as determined by the study sites using the WASID method. There was a 10.4% rate of restenosis >50% or 8 patients out of 77 analyzed. The differences in this analysis population N=77 vs. ITT N= 82 populations results from exclusion of N=4 patients with no stent implanted and N=1 patient who died prior to any follow up measures of restenosis.
The WASID method is a standardized protocol for measuring intracranial arterial stenosis.
[1-(Dstenosis/Dnormal)] x100=% stenosis (where D=vessel diameter)"|12 Months|There were only N=77 patients available for analysis of restenosis at 12 months. This differs from the original N=82 ITT population in that denominator is based on the number of subjects available at 30 day follow up. Five subjects who exited the study at discharge were excluded from the analysis (no stent implanted (4), death (1)).||participants|||Number
796446|NCT00929383|Secondary|Cumulative Stroke Rate at 12 Months|The cumulative stroke rate at 12 months (any stroke or neurological death </= 30 days or any ischemic stroke in territory >/= 31 days is 15.9% or 13 events per 82 patients|12 months|(ITT) Intent-to-treat||participants|||Number
796447|NCT00929383|Primary|Rate of Recurrent Ischemic Stroke in the Target Territory|The rate of recurrent ischemic stroke from 31 days to 12 months post procedure was 1.3% or 1 event per 77 patients analyzed.|12 Months|(ITT) Intent-to-treat||participants|||Number
796448|NCT00929383|Primary|Cumulative Morbidity and Mortality Rate (Ischemic Event, Parenchymal Brain Hemorrhage, Subarachnoid or Intraventricular Hemorrhage or Death)|"Any stroke or neurological death at </= 30 days will be included in the cumulative morbidity and mortality rate.
There was a 14.6% rate of cumulative morbidity and mortality at 30 days comprised of 12 events/82 patients."|30 days|(ITT) Intent-to-treat||participants|||Number
796449|NCT00929383|Primary|Successful Wingspan™ Stent Implantation (Access to the Lesion With the Stent, Accurate Deployment of the Stent Across the Target Lesion)|The number of Wingspan Stents successfully deployed across the target lesion.|Peri-procedural|(ITT) Intent-to-treat||patients w stent implanted|||Number
796450|NCT00923273|Primary|Phase I: Maximum Tolerated Dose (MTD) of Sirolimus|The phase I component of the study are to determine the safety and tolerability of sirolimus in human subjects with non small cell lung cancer (NSCLC), and to determine the maximum tolerated dose.|5 weeks|||mg/m^2|||Number
796451|NCT00923273|Primary|Phase II: Clinical Response Rate|Clinical response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions. Partial response (PR) at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|21 weeks|By formal criteria in the protocol, DL4 exceeds the MTD, and DL 3 would be expanded by 3 subjects to confirm it's tolerability. We believe that DL4 is safe, and that the observed DLTs at this DL are related to enrollment of a subject with a borderline performance status, and the omission of defining length of neutropenia as a DLT.||Participants|||Number
796452|NCT00923273|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|45 months|||Participants|||Number
796453|NCT00923273|Primary|Phase I: Maximum Tolerated Dose (MTD) of Pemetrexed|The phase I component of the study are to determine the safety and tolerability of pemetrexed in human subjects with non small cell lung cancer (NSCLC), and to determine the maximum tolerated dose.|5 weeks|||mg/m^2|||Number
796457|NCT00923481|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|23 months|||Participants|||Number
796458|NCT00923481|Primary|Response Rate|Response is assessed by the RECIST (response criteria in solid tumors)criteria. A complete response (CR) is disappearance of all target lesions , partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, and stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|24 months|||Participants|||Number
796459|NCT00929474|Secondary|All-cause Cardiovascular and Heart Failure Hospitalizations; All-cause Cardiovascular and Heart Failure Mortality; Changes in Paced/Sensed AV and V-V Delays; Percent Atrial and Ventricular Pacing||Not assessed||||||
796460|NCT00929474|Secondary|6-minute Hall Walk; Intrinsic QRS Width; Echo Measurements (End Diastolic Volume, End Systolic Volume, Ejection Fraction, Left Ventricular Mass, Mitral Regurgitation, Tricuspid Regurgitation, and Interventricular and Intraventricular Mechanical Delays)||Not assessed||||||
796461|NCT00929474|Secondary|Modified Specific Activity Scale (SAS); Quality-of-life (QOL) Score as Measured by Minnesota Living With Heart Failure (MLHF) Questionnaire||Not assessed||||||
796462|NCT00929474|Primary|Stroke Volume (SV) Measured by Aortic Velocity Time Integral (AoVTI)|The BOOST study is prematurely terminated so there were no enough numbers of patients to have a meaningful measurement.|Not assessed||||||
796463|NCT00929500|Secondary|Muscle Strength|MAST sessions were held twice a week for 16 weeks. Each exercise session consisted of 10 min of warm-up, 15–30 min of interval aerobic training by cycle ergometer according to the program, 20 min of strength training exercises, and 10 min of cool-down by stretching. The target heart rate (HR) increased progressively from 50% up to 80% of HR reserve by the end of the intervention period.The Karvonen formula ([(HRmax – HRrest)×(0.50 to 0.80)] + HRrest) was used to calculate the target HR. During every training session a new wireless computerized ECG monitoring system was used. After aerobic training, the strength training program was performed. Exercises used body mass as resistance and included squat, step-up-squat, step-up, heel rise, and sit-ups. Dumbbells were used as extra weight (5 or 10% of body weight) during other exercises except for sit-ups. The control group participated in an educational session once a month and kept physical activity diaries during the intervention period.|At baseline and after 4 months of intervention|||W||Standard Deviation|Mean
796464|NCT00929500|Secondary|Trail Making Test|The Trail Making (TM) test is a measure of shifting attention. Participants are required to sequentially connect a series of numbered circles (Part A), and then to alternate between numbers and letters sequentially (Part B) (e.g., A-1-B-2-C-3..). Any participant who has not completed Part B within the standard 5 minutes (300 seconds) allotted for the task will be considered unable to complete the task. The scores in Part A (TM-A), Part B (TM-B), and their difference (TM-B –TM-A) were calculated and used to measure executive function, i.e., lower scores indicates better performance.|At baseline and after 4 months of intervention|||s||Standard Deviation|Mean
796465|NCT00929500|Secondary|Cerebral Blood Flow Velocity (BFV)|Cerebral BFV was monitored using Transcranial Doppler Ultrasound.11 The middle cerebral artery was insonated from the temporal window by placing the 2-MegaHertZ (MHz) probe against the skin of the temporal region above the zygomatic arch. The probe was positioned to obtain maximal BFV and was fixed at the desired angle using a 3-dimensional positioning system. Once instrumented, BFV was continuously recorded throughout ten minutes of supine rest and 10-minutes on a table tilted to 80° from the horizontal position (head-up with foot plate support).|At baseline and after 4 months of intervention|||cm/s||Standard Deviation|Mean
796466|NCT00929500|Primary|Maximal Oxygen Uptake|To obtain peak oxygen uptake (VO2max; ml−1/min−1/kg), a symptom-limited exercise stress test was performed on a cycle ergometer. The test was preceded by a 2-minute warm-up at the intensity of 20 W. The first test load was 20 W, and was increased by 20 W at each 2-minute stage until the participants could no longer continue, i.e., they were unable to maintain pedaling frequency > 40 rpm, they achieved a respiratory exchange ratio of more than 1.0, or clinical criteria for test termination was observed. VO2max was measured and monitored with a breath-by-breath gas exchange system.|At baseline and after 4 months of intervention|||ml/kg/min||Standard Deviation|Mean
796467|NCT00929526|Secondary|Number of Subjects With Pregnancies and Pregnancy Outcomes.|Pregnancy outcomes are live infant, elective termination, ectopic pregnancy, stillbirth, spontaneous abortion, lost to follow-up and pregnancy ongoing. For each category it was specified if the infant presents congenital anomaly (CA) or no apparent congenital anomaly (No ACA).|During the follow-up period from last study visit at Month 24 in the primary vaccination study NCT00316693 until the end of this follow-up study at Month 12 (Month 48 Ext- NCT00316693).|The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available.||Subjects|||Number
796468|NCT00929526|Secondary|Number of Subjects With Medically Significant Conditions (MSCs).|MSCs were defined as adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common disease.|During the follow-up period from last study visit at Month 24 in the primary vaccination study NCT00316693 until the end of this follow-up study at Month 12|The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available.||Subjects|||Number
796517|NCT00929708|Primary|FEV1, E0−4; the Average Value at Visit 5 From Before to 4 Hours After Morning Dose (Peak Effect)|change from baseline|0,5 min, 15 min, 60 min, 2 h, 4 h|||Litre||Standard Deviation|Mean
796470|NCT00929526|Secondary|Number of Subjects With New Onset of Chronic Diseases (NOCDs) Regardless of Causal Relationship to Vaccination and Intensity.|NOCDs included autoimmune diseases, diabetes mellitus.|During the follow-up period from last study visit at Month 24 in the primary vaccination study NCT00316693 until the end of this follow-up study at Month 12|The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available.||Subjects|||Number
796471|NCT00929526|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|During the follow-up period from last study visit at Month 24 in the primary vaccination study NCT00316693 until the end of this follow-up study at Month 12|The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available.||Subjects|||Number
796472|NCT00929526|Secondary|HPV-16 and HPV-18 Antibody Titers|Titers were expressed as Geometric Mean Titers (GMTs). Geometric mean titres were assessed by ELISA in the Cervarix Group.|At Month 0 and at Month 12|The According-To-Protocol cohort for immunogenicity M48 EXT- NCT00316693 included all evaluable subjects for whom data concerning immunogenicity outcome measures were available in this current follow-up study for antibodies against at least one study vaccine antigen component.||Titers||95% Confidence Interval|Geometric Mean
796473|NCT00929526|Secondary|Number of Subjects With HPV-16 and HPV-18 Antibodies Titers Equal to or Above the Assay Cut-off Values.|Assay cut-off values assessed were 8 Enzyme-linked Immunosorbent Assay (ELISA) units per millilitre (EL.U/mL) for HPV-16 antibodies and 7 ELISA units per millilitre (EL.U/mL) for HPV-18 antibodies in the Cervarix Group.|At Month 0 and at Month 12|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available in this current follow-up study for antibodies against at least one study vaccine antigen component.||Subjects|||Number
796474|NCT00929526|Secondary|Number of Subjects Reporting Persistent Long-term Cervical Infection (12-month Definition) With Any Oncogenic HPV-types.|"Persistent infection: subjects with at least 2 positive samples (difference > than 300 days) and no negative samples in between.
HR=High-risk HPV-types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68."|From Month 0 up to Month 12|The analysis was performed in subjects who were negative for HPV DNA at baseline and Month 6 in the primary study (NCT00316693) for the HPV-type considered, regardless of their initial serostatus and for whom data concerning efficacy outcome measures were available in this current follow-up study.||Subjects|||Number
796475|NCT00929526|Secondary|Number of Subjects Reporting Persistent Long-term Cervical Infection (12-month Definition) With HPV-16 and/or 18.|"Persistent infection (12-month definition): detection of at least 2 positive HPV DNA PCR assays for the same viral genotype with no negative DNA sample between the 2 positive DNA samples, over an approximate interval of 12 months (>300 days).
For single type: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for the corresponding HPV type.
For combined types: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for at least one HPV type."|From Month 0 up to Month 12|The analysis was performed in subjects who were seronegative at baseline and negative for HPV DNA at baseline and Month 6 in the primary study (NCT00316693) for the HPV-type considered and for whom data concerning efficacy outcome measures were available in this follow-up study.||Subjects|||Number
796476|NCT00929526|Secondary|Number of Subjects Reporting Incident Cervical Infection With Any Oncogenic HPV Types.|HR=High-risk HPV-types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.|From Month 0 up to Month 12|The analysis was performed in subjects who were negative for HPV DNA at baseline and Month 6 in the primary study (NCT00316693) for the HPV-type considered, regardless of their initial serostatus and for whom data concerning efficacy outcome measures were available in this current follow-up study.||Subjects|||Number
796477|NCT00929526|Secondary|Number of Subjects Reporting Incident Cervical Infection Associated With HPV-16 and/or 18.|"For single type: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for the corresponding HPV type.
For combined types: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for at least one HPV type."|From Month 0 up to Month 12|The analysis was performed in subjects who were seronegative at baseline and negative for HPV DNA at baseline and Month 6 in the primary study (NCT00316693) for the HPV-type considered and for whom data concerning efficacy outcome measures were available in this follow-up study.||Subjects|||Number
796478|NCT00929526|Secondary|Number of Subjects Reporting CIN1+ Associated With Any Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen.|"Low-grade cervical lesions and higher lesions are defined as CIN1+, i.e. CIN1, CIN2, CIN3, AIS or ICC.
HR=High-risk HPV-types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68."|From Month 0 up to Month 12|The analysis was performed in subjects who were DNA negative at baseline and Month 6 in the primary study (NCT00316693) for the HPV-type considered, regardless of their initial serostatus and for whom data concerning efficacy outcome measures were available in this current follow-up study.||Subjects|||Number
796479|NCT00929526|Secondary|Number of Subjects Reporting Cytologically Confirmed Abnormalities and Lesions Concurrently Associated With Any Oncogenic HPV Types.|"Cytologically confirmed abnormalities and lesions (ASC-US+) are defined as ASC-US, LSIL, HSIL, ASC-H and AGC.
HR= High-risk HPV-types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68."|From Month 0 up to Month 12|The analysis was performed in subjects who were DNA negative at baseline and Month 6 in the primary study (NCT00316693) for the HPV-type considered, regardless of their initial serostatus and for whom data concerning efficacy outcome measures were available in this current follow-up study.||Subjects|||Number
796480|NCT00929526|Secondary|Number of Subjects Reporting Cytological Abnormalities and Lesions Associated With HPV-16 and/or HPV-18.|"Cytologically confirmed abnormalities and lesions (ASC-US+) are defined as atypical squamous cell of undetermined significance (ASC-US), low-grade squamous intraepithelial lesions (LSIL), high-grade squamous intraepithelial lesions (HSIL), atypical squamous cell-cannot exclude HSIL (ASC-H) and atypical glandular cells (AGC).
For single type: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for the corresponding HPV type.
For combined types: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for at least one HPV type."|From Month 0 up to Month 12|The analysis was performed in subjects who were seronegative at baseline and negative for HPV DNA at baseline and Month 6 in the primary study (NCT00316693) for the HPV-type considered and for whom data concerning efficacy outcome measures were available in this follow-up study.||Subjects|||Number
796481|NCT00929526|Primary|Number of Subjects Reporting Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Cases Associated With HPV16 and/or HPV18 Detected Within the Lesional Component of the Cervical Tissue Specimen.|"Low-grade cervical lesions and higher lesions are defined as CIN1+, i.e. CIN grade 1 (CIN1), CIN grade 2 (CIN2), CIN grade 3 (CIN3), adenocarcinoma in situ (AIS) or invasive cervical cancer (ICC).
Detection of vaccine oncogenic Human papillomavirus (HPV) types 16 or 18 was made by polymerase chain reaction (PCR).
For single type: Subjects Deoxyribonucleic acid (DNA) negative at Month 0 and Month 6 and seronegative at Month 0 for the corresponding HPV type.
For combined types: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for at least one HPV type."|From Month 0 up to Month 12|The analysis was performed in subjects who were seronegative at baseline and negative for human papillomavirus (HPV) desoxyribonucleic acid (DNA) at baseline and Month 6 in the primary study (NCT00316693) for the HPV-type considered and for whom data concerning efficacy outcome measures were available in this follow-up study.||Subjects|||Number
796482|NCT00929578|Secondary|Fluphenazine Serum Levels Measured at Baseline, 2 Hours Post Dose and 1 Week Post Dose.|Number of participants with fluphenazine serum levels > 0.200ng/ml, at baseline, 2 hours post dose and 1 week post dose.|1 week|All participants who were enrolled and completed baseline and week 1 were included.||participants|||Number
796483|NCT00929578|Secondary|Safety Outcome Measures|adverse events will be recorded and monitored. Adverse events will be noted in a separate chart.|8 weeks|All participants who completed enrollment.||All Study Participant|||Number
796484|NCT00929578|Secondary|Change in the Target Lesion Visual Analog Scale (VAS) Score for Pruritus Evaluated at Baseline and 4 Weeks|Visual Analog Scale (VAS) score for pruritus. Subjective measurement of pruritus on an analog scale with a single mark denoting self-perceived pruritus: Minimum 0mm for no itch, Maximum 100mm for worst itch imaginable. Scores are measured in millimeters. This secondary outcome is a percentage improvement from baseline score for pruritus. Improvement is negative, worsening is positive.|4 weeks|Participants who completed entire trial.||percentage of baseline pruritus||Standard Deviation|Mean
796485|NCT00929578|Primary|Change in Target Lesion Scoring Evaluated at Baseline and 4 Weeks|Actual change in target lesion score comparing 4 week score with baseline score. Improvement is positive, worsening is negative. Target lesions scores range from 0 (no disease) to 12 (severe disease), and are scored based on the sum of erythema (0-4), induration (0-4) and scale (0-4) scores.|4 weeks|All participants who successfully were enrolled.||units on a scale||Standard Deviation|Mean
796486|NCT00929643|Secondary|Percentage of Participants by Diagnosis at Discharge||Month 6 or study exit|FAS||Percentage of participants|||Number
796487|NCT00929643|Secondary|Percentage of Participants With Specific Pathogen||Baseline up to 6 months|FAS||Percentage of participants|||Number
796488|NCT00929643|Primary|Duration of Hospitalization (by Failure of Initial Empiric Treatment)|Yes equals (=) initial empiric antibiotic treatment failed (additional antibiotic therapy or a change in antibacterial therapy was required following laparotomy/laparoscopy or percutaneous draininge or participant died due to infection); No=initial empiric antibiotic treatment successful (infectious process resolved and no change in initial empiric antibiotic therapy was required during the course of hospitalization except for stepdown therapy, de-escalation or intravenous to oral switch).|Baseline up to 6 months|FAS; n=number of participants with nonmissing data||Days||Standard Deviation|Mean
796489|NCT00929643|Primary|Percentage of Participants With Failure of Initial Empiric Antibiotic Therapy|Failure of initial empiric therapy was assessed by an independent committee of qualified healthcare professionals (surgeon, and microbiologist specialist) and defined as requirement of additional antibiotic or change in antibacterial therapy on any day following the initial laparotomy, laparoscopy, or percutaneous drainage; or additional laparotomy, laparoscopy, or percutaneous drainage at least 2 days following the initial surgical/radiological intervention; or participant death due to infection.|Baseline up to 6 months|FAS; n=number of participants in which failure could be assessed||Percentage of participants|||Number
796490|NCT00929643|Primary|Percentage of Participants With Initial Empiric Antibiotic Therapy (by Therapeutic Class)||Baseline up to 6 months|FAS||Percentage of participants|||Number
796491|NCT00929643|Primary|Duration of Hospitalization|Overall health care resource utilization was analyzed using mean duration of hospitalization.|Baseline up to 6 months|Full Analysis Set (FAS): All enrolled participants who fulfilled the protocol inclusion criteria. N=number of participants with nonmissing data.||Days||Standard Deviation|Mean
796492|NCT00929656|Secondary|Motor Activity Log - How Well Change|"Self-Report of How Well paretic UE performed completing 30 functional tasks. Each task is reported on a 0-5 scale with 0 representing Unable to use my paretic hand to perform that task and 5 representing My paretic hand performs that task as well as it did before the stroke. A 5 on each task would be considered normal."|Change between Pre-intervention (baseline) to Post-intervention (4 wks following pre-intervention)|||Units on a scale||Standard Error|Mean
796493|NCT00929656|Secondary|Motor Activity Log - Amount of Use Change|"Self-Report Amount of Use of Paretic UE to complete 30 functional tasks. Each task is reported on a 0-5 scale with 0 representing did not use my paretic hand at all for that task and 5 representing I used my paretic hand as much as before the stroke to complete that task. A 5 on each task would be considered normal."|Change Between Pre-intervention (baseline) to Post-intervention (4 wks following pre-intervention)|||Units on a scale||Standard Error|Mean
796494|NCT00929656|Secondary|Grip Strength Change|Change in Paretic hand grip strength from pre- to post-intervention. Grip strength measured by hand-held dynamometer. An average of 3 5-second trials was used for analysis.|Change between Pre-intervention (baseline) to Post-intervention (4 wks following pre-intervention)|||kilograms||Standard Error|Mean
796495|NCT00929656|Secondary|Upper Extremity Fugl-Meyer Motor Assessment Change|Change in Score from Pre-intervention to Post-Intervention. This outcome measures arm motor control; the ability to move outside of pathologic synergistic patterns. It is a measure of impairment in Body Structure/Function. Total score ranges from 0-66, with 0 indicative of no movement and 66 considered normal motor control.|Change Between Pre-intervention (baseline) to Post-intervention (4 wks following pre-intervention)|||units on a scale||Standard Error|Mean
796496|NCT00929656|Primary|Wolf Motor Function Test Change|Change, in seconds, between Pre-intervention and post-intervention (4 wks following pre-intervention). The time to complete 15 separate upper extremity functional tasks are recorded. These 15 separate timed events are averaged to provide one time, in seconds. This is considered an Activity Measure on the WHO ICF model.|Change between Pre-intervention (baseline) to Post-intervention (4 wks following pre-intervention)|||seconds||Standard Error|Mean
796499|NCT00929695|Secondary|Secondary Therapy for Acute GVHD Beyond Prednisone|This includes any intervention intended to control acute GVHD through an immunosuppressive effect from oral or parenteral administration of any systemic medication not given previously. This does not include topical therapy, an increase in the dose of glucocorticoids or the resumption of treatment after previous discontinuation or any increase in the dose of immunosuppressive medication previously administered for GVHD prophylaxis, or reinstatement of GVHD prophylaxis previously discontinued. A change in treatment from cyclosporine to tacrolimus or vice versa because of drug toxicity is not considered secondary therapy, but any change made because of uncontrolled GVHD is considered secondary therapy. Percentage is estimated by cumulative incidence methods.|At approximately 100 days after transplant|||percentage of participants|||Number
796500|NCT00929695|Secondary|Progression to Grade III-IV Acute GVHD|Diagnosed and graded according to standard established criteria. Measure is percent of patients with baseline scores of IIa (Group A) or IIb (Group B) who progressed to more severe GVHD (Grade III/IV). Percentage estimated by cumulative incidence methods.|At approximately 100 days after transplant|||percentage of participants|||Number
796501|NCT00929695|Secondary|Recurrent or Progressive Malignancy|Percentage of relapse estimated by cumulative incidence methods|At 12 months after the start of prednisone therapy|||percentage of participants|||Number
796502|NCT00929695|Secondary|Non-relapse Mortality|Non-relapse mortality (NRM) is defined as death due to any cause in the absence of documented relapse/progression.|At 12 months after the start of prednisone therapy|||percentage of participants|||Number
796503|NCT00929695|Secondary|Prednisone-associated Toxicity as Assessed by Quality of Life|Patients completed the MD Anderson Symptom Inventory (MDASI), which is a quality of life questionnaire validated for oncology/transplant patients. On a 1-10 point scale, patients scored the degree of severity of symptoms or the degree of interference in feelings or function due to symptoms at baseline or in the previous week. A score of 1 indicates symptom is not present or does not interfere with feelings or function. A score of 10 indicates the symptom is as bad as you can imagine or interferes completely with feelings or function. The mean change in score from baseline to day 42 was measured.|Baseline and then every other week until 42 days after starting treatment|||units on a scale||Full Range|Mean
796504|NCT00929695|Secondary|Prednisone-associated Toxicity as Assessed by Hypertension|The number of different anti-hypertensive medications administered to control hypertension were collected. The mean change in the number of medications from baseline to day 42 was measured.|Baseline and then through 42 days after starting treatment|||medications||Full Range|Mean
796505|NCT00929695|Secondary|Prednisone-associated Toxicity as Assessed by Myopathy|Assessed by mean change from baseline to day 42 using Manual Muscle Testing measure. The degree of resistance against pressure applied by tester was measured on a 5-point scale. A score of 5 indicates the patient can hold the position against maximum to strong resistance. A score of 0 indicates the patient has no resistance against pressure. Testing included upper and lower extremities: shoulder (deltoid at 90 degrees), and hip and knee in a sitting position.|Baseline and then weekly until 42 days after starting treatment|||units on a scale||Full Range|Mean
796506|NCT00929695|Secondary|Prednisone-associated Toxicity as Assessed by Invasive Infections (Bacterial, Fungal and Viral)|The total number of invasive infections (bacterial, fungal and viral) occurring in patients in each group were collected.|Baseline and through 100 days of treatment|||percentage of participants|||Number
796507|NCT00929695|Secondary|Prednisone-associated Toxicity as Assessed by Hyperglycemia|Impact on blood glucose (BG) control will be assessed by comparing average BG and BG-variability between patients given standard-dose and low-dose prednisone.|Baseline and then through 42 days after starting treatment|||mg/dL||Standard Error|Mean
796508|NCT00929695|Primary|Mean Cumulative Prednisone Dose (mg/kg) Over 42 Days From the Start of Treatment|The total cumulative dose of prednisone (milligrams/kilogram) was calculated starting from the start of therapy through study day 42.|At day 42 after initiation of treatment|From a total enrollment of 164 patients, the cumulative dose of prednisone at day 42 of treatment was available in 152 patients. The primary outcome was not measured in 12 patients due to withdrawal from study (2), discharge from Center before day 42 of treatment (10). Analysis was not completed in two patients due to an error in stratification.||milligrams per kilogram||Standard Deviation|Mean
796509|NCT00929708|Secondary|Total Score SGRQ-C (St George’s Respiratory Questionnaire for COPD)|The total score is calculated using all questions including their weights and scores range from 0 (perfect health) to 100 (worst possible state)|At baseline (visit 2) and after 4 weeks of treatment (visit 5).|||Score||Standard Deviation|Mean
796510|NCT00929708|Secondary|Overall Mean CCQ (Clinical COPD Questionnaire)|Change from baseline to treatment in score. The total scores vary between 0 (never/not limited at all) to 6 (almost all the time/totally limited). The data below represent the average of week 1,2,4 minus week 0.|Mean over week 0, mean over week 1, mean over week 2, and mean over week 4|||score on scale||Standard Deviation|Mean
796511|NCT00929708|Secondary|Total AstraZeneca COPD Symptoms Scores (Included Breathlessness, Chest Tightness, Cough and Night-time Awakenings)|Score on a scale 5-point Likert-type scale, ranging from 0 (none) to 4 (severe) for each symptom, total score is the sum of each symptom ranged from 0 to 16. Change from run-in.|Daily, during run-in and treatment|||total score||Standard Deviation|Mean
796512|NCT00929708|Secondary|Total Number of Reliever Medication Inhalations Per 24h|Change from run-in|During day (from rising from bed until going to bed) and night (from going to bed until rising from bed) at visit 1 to visit 5 (24h), up to 4 weeks.|||Number of reliver inh.||Standard Deviation|Mean
796513|NCT00929708|Secondary|FEV1 Post Salbutamol Inhalation|Mean value of FEV1 pre and post salbutamol at visit 2 and visit 5|Baseline (visit 2) and 26 h after the last morning dose (visit 5).|||Litre||Standard Deviation|Mean
796514|NCT00929708|Secondary|AUC0-24; Area Under the Plasma Concentration Curve From Zero to 24 Hours After Dose|PK is only measured for AZD3199|0,15 min, 1, 4 and 24 hours post dose|AZD3199 plasma data were available for 178 of the 199 randomized patients, but data from 2 patients in AZD3199 200 mcg group were excluded from analysis because most of the values were below LOQ.||nmol*h/L||Full Range|Geometric Mean
796515|NCT00929708|Secondary|Cmax; the Highest Plasma Concentration of AZD3199 Measured|PK is only measured for AZD3199|0,15 min, 1, 4 and 24 hours post dose|AZD3199 plasma data were available for 178 of the 199 randomized patients, but data from 2 patients in AZD3199 200 mcg group were excluded from analysis because most of the values were below LOQ.||nmol/L||Full Range|Geometric Mean
836631|NCT01289847|Secondary|Therapeutic Efficacy|Number of days off school|12 months|||days||Standard Deviation|Mean
796522|NCT00929773|Secondary|Change in Range of Motion (ROM) for the Right Shoulder From Baseline to One Hour After Study Treatment.|Range of motion (ROM) for the right shoulder is a measure of how well the participant can move the right shoulder. The participant gently raises the right shoulder (with right arm) as far as possible, and this distance is measured in degrees. The change for ROM for the right shoulder is measured as the difference in degrees of ROM recorded from baseline to one hour after study treatment. If the change is positive (+), this means that ROM has gotten better and the right shoulder can move further more easily than before getting the treatment. If the change is negative (-), this means that ROM has gotten worse and the right shoulder can move less and not as far to the left side than before getting the treatment.|baseline and one hour|||degrees||Standard Deviation|Mean
796523|NCT00929773|Secondary|Change in Range of Motion (ROM) for the Right Side of the Neck From Baseline to One Hour After Study Treatment.|Range of motion (ROM) for the right side of the neck is a measure of how well the neck can move to the right side. The participant gently tilts their neck to the right side as far as possible, and this distance is measured in degrees. The change for ROM for the right side of the neck is measured as the difference in degrees of ROM recorded from baseline to one hour after study treatment. If the change is positive (+), this means that ROM has gotten better and the neck can move further to the right side than before getting the treatment. If the change is negative (-), this means that ROM has gotten worse and the neck can move less to the right side than before getting the treatment.|baseline and one hour|||degrees||Standard Deviation|Mean
796524|NCT00929773|Primary|Change in Self-reported Degree of Pain in the Neck-shoulder Region on the 0-100 Visual Analog Scale (VAS)|Self-reported degree of pain in the neck and shoulder region on the Visual Analog Scale (VAS). The VAS is a 100 mm long horizontal line ranging from '0: no pain at all' on one end to '100: worst pain imaginable' on the other end. Participants mark a point along the line that best represents the pain they are experiencing at that moment. The change is calculated as the difference from the VAS score recorded at baseline to the VAS score recorded one hour after study treatment administration. A positive change (+) means that the pain got worse and a negative change (-) means that the pain got better.|baseline and one hour|||units on a scale||Standard Deviation|Mean
796525|NCT00929773|Secondary|Change in Range of Motion (ROM) for the Left Shoulder From Baseline to One Hour After Study Treatment.|Range of motion (ROM) for the left shoulder is a measure of how well the participant can move the left shoulder. The participant gently raises the left shoulder (and left arm) as far as possible, and this distance is measured in degrees. The change for ROM for the left shoulder is measured as the difference in degrees of ROM recorded from baseline to one hour after study treatment. If the change is positive (+), this means that ROM has gotten better and can move the left shoulder better and further than before getting the treatment. If the change is negative (-), this means that ROM has gotten worse and the left shoulder can move less easily and not as far than before getting the treatment|one hour|||degrees||Standard Deviation|Mean
796526|NCT00929773|Secondary|Change in Range of Motion (ROM) for the Left Side of the Neck From Baseline to One Hour After Study Treatment.|Range of motion (ROM) for the left side of the neck is a measure of how well the neck can move to the left side. The participant gently tilts their neck to the left side as far as possible, and this distance is measured in degrees. The change for ROM for the left side of the neck is measured as the difference in degrees of ROM recorded from baseline to one hour after study treatment. If the change is positive (+), this means that ROM has gotten better and the neck can move further to the left side than before getting the treatment. If the change is negative (-), this means that ROM has gotten worse and the neck can move less to the left side than before getting the treatment|baseline and one hour|||degrees||Standard Deviation|Mean
796527|NCT00929773|Primary|Number of Participants Whose Self-reported Degree of Pain on the Visual Analog Scale (VAS) in the Neck and Shoulder Area Decreased by 30% or More From Before to After Study Treatment.|Self-reported degree of pain in the neck and shoulder region on the Visual Analog Scale (VAS). The VAS is a 100 mm long horizontal line ranging from '0: no pain at all' on one end to '100: worst pain imaginable' on the other end. Participants mark a point along the line that best represents the pain they are experiencing at that moment.|baseline and one hour|||participants|||Number
796532|NCT00932165|Primary|Number of Post-operative Adjuvant Therapy Participants With Breast Cancer Recurrence Status||24 weeks|The participants who were evaluated for efficacy of Aromasin for the post-operative adjuvant therapy.||participants|||Number
796533|NCT00932165|Primary|Number of Tumor Responders in Progressive Breast Cancer or Recurrent Breast Cancer to Exemestane Treatment|Anti-tumor effect was evaluated according to the rules for ‘General Rules for Clinical and Pathological Recording of Breast Cancer’ (the 15th edition)/Response Evaluation Criteria in Solid Tumors (RECIST) Guideline. Judged as Completed response (CR) or partial response (PR), stable disease (SD) or progressive disease (PD) after the treatment start.|24 weeks|N = number of participants with tumor response||participants|||Number
796534|NCT00932165|Secondary|Number of Participants With Adverse Drug Reaction for Subjects With Renal Dysfunction|The participants who were diagnosed by the investigator as the participants with renal dysfunction, and observed for safety information.|24 weeks|Subjects with renal Dysfunction.||participants|||Number
796535|NCT00932165|Primary|Number of Participants With Adverse Drug Reaction|Confirmation of the number of subjects with treatment related adverse events. All adverse events regardless of causal relationship with Aromasin Tablet at the end of observation period was reported.|24 weeks|Safety analysis population included all enrolled subjects who had received at least 1 confirmed, administration of exemestane.||participants|||Number
796550|NCT00932373|Primary|Maximum Tolerated Dose (MTD)|The highest dose level resulting in a DLT in ≤ 1 of 6 patients was declared the MTD.|A minimum of 21 days after first dose of trastuzumab-MCC-DM1|Safety evaluable population: All participants who received at least 1 dose of trastuzumab-MCC-DM1||mg/kg|||Number
796536|NCT00932165|Primary|Number of Participants With Performance Status Score Based on Eastern Cooperative Oncology Group (ECOG) Factors Considered to Affect the Safety and/or Efficacy of Exemestane|Scale 0; Asymptomatic (Fully active, able to carry on all predisease activities without restriction), 1; Symptomatic but completely ambulatory (Restricted in physically strenuous activity ,ambulatory and able to carry out light or sedentary work), 2 ; Symptomatic, <50% in bed during the day (Ambulatory,capable of all self care, unable to carry out any work activities., 3; Symptomatic, >50% in bed, not bedbound (Capable of only limited self-care, confined to bed or chair 50% or more waking hours), 4; Bedbound (Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair)|24 weeks|||participants|||Number
796537|NCT00932165|Secondary|Number of Participants With Adverse Drug Reaction for Subjects With Hepatic Dysfunction|The participants who were diagnosed by the investigator as the participants with hepatic dysfunction, and observed for safety information.|24 weeks|Subjects with hepatic Dysfunction.||participants|||Number
796538|NCT00932165|Primary|Number of Participants With Factors Considered to Affect the Safety and/or Efficacy of Exemestane|Assessment of factors likely to affect the safety and/or efficacy: reason for Exemestane use (primary progressive breast cancer, relapsed breast cancer or postoperative adjuvant therapy)and past history (presence or absence of at least one disease).|24 weeks|Safety analysis population included all enrolled subjects who had received at least 1 confirmed, administration of exemestane.||participants|||Number
796539|NCT00932165|Secondary|Number of Participants With Unexpected Adverse Drug Reaction|"Adverse drug reaction that is not included in the “precautions for use”or undesirable effects section in the package insert (same as Local Product Document)."|24 weeks|Safety analysis population included all enrolled subjects who had received at least 1 confirmed, administration of exemestane.||participants|||Number
796540|NCT00932282|Secondary|Incidence of Side Effects During Initial Escalation and Build up Phase of Peanut Oral Immunotherapy|The primary safety outcome of the study is to determine the frequency of side effects during oral immunotherapy in order to assess whether the addition of anti-IgE therapy using Xolair to peanut oral immunotherapy can reduce the number of allergic symptoms that occur during oral immunotherapy when compared to previously published results|approximately 24 or 36 months|||side effects reported per 100 OIT doses|||Number
796541|NCT00932282|Secondary|Incidence of All Serious Adverse Events During the Study|A secondary safety outcome of the study is to determine the frequency of SAEs during oral immunotherapy in order to assess whether the addition of anti-IgE therapy using Xolair to peanut oral immunotherapy can reduce the number of SAEs that occur during oral immunotherapy when compared to previously published results|approximately 24 or 36 months|||SAEs per 100 OIT doses taken|||Number
796542|NCT00932282|Secondary|The Percentage of Subjects Who Pass the 20gm Peanut Flour (~50% Peanut Protein) Oral Food Challenge Following the Desensitization Phase of the Study|A secondary efficacy outcome of the study is to evaluate whether the addition of anti-IgE therapy using Xolair to peanut oral immunotherapy is able to induce clinical desensitization as measured by passing an oral food challenge to 20 grams of peanut flour on the final day of peanut OIT dosing.|approximately 24 or 36 months|||Participants|||Count of Participants
796543|NCT00932282|Secondary|The Percentage of Subjects Who Tolerate the Initial Desensitization Day(s) to 950mg of Peanut Flour.|A secondary efficacy outcome of the study is to evaluate whether the addition of anti-IgE therapy using Xolair to a peanut oral immunotherapy protocol allows for a higher amount of peanut tolerated after the rush desensitization phase, thereby reducing the duration of buildup phase and achieving maintenance dosing more rapidly|4 months|||Participants|||Count of Participants
796544|NCT00932282|Primary|The Percentage of Subjects Who Pass the 20gm Peanut Flour (~50% Peanut Protein) Oral Food Challenge 2-4 Weeks After Discontinuing Peanut OIT Therapy|The primary efficacy outcome of the study is to evaluate whether the addition of anti-IgE therapy using Xolair to peanut oral immunotherapy is able to induce clinical tolerance as measured by passing an oral food challenge to 20 grams of peanut flour, 2-4 weeks after discontinuing peanut OIT therapy|approximately 24 or 36 months|||Participants|||Count of Participants
796545|NCT00932321|Secondary|Mean Number of Intracyclic Bleeding (IB)/Spotting Days in Cycles 2-6, MITT Population|Self-reported via patient completed diary (none - no vaginal bleeding, light - less than normal menstruation, normal - like normal menstruation, heavy - more than normal menstruation) along with daily use of sanitary protection (other than panty liners). Light bleeding requiring no more than single pad or tampon will be spotting.|5.6 months (6 - 28 day cycles)|Modified Intent to Treat (MITT)||Days||Standard Deviation|Mean
796546|NCT00932321|Primary|Pregnancy Rate (Expressed as Pearl Index) for Women 18 to 45 Years Old, MITT Population|Pearl Index = 1300 * number of pregnancies/number of women-cycles of treatment|5.6 months (6 - 28 day cycles)|Modified intention to treat (MITT) subset of all treat subjects - evaluated for pregnancy at least once after beginning study medication.||Pearl Index|||Number
796547|NCT00932373|Primary|PK Parameters After the First Dose: Terminal Half-life (t½) for T-DM1 Concentrations|Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.|3-Week and Weekly Cohorts: Cycle 1 Day 1 Pre-dose 30 minutes and 4 hours after the end of infusion; Cycle 1 Day 2, 3, 4, 8 (Pre-dose 30 minutes after the end of infusion) 11, 15 (Pre-dose 30 minutes after the end of infusion) and 18|Pharmacokinetic-evaluable patients were defined as patients who received at least one dose of T-DM1 with at least one post-dose concentration data point.||day||Standard Deviation|Mean
796548|NCT00932373|Primary|PK Parameters After the First Dose: Area Under the Plasma Concentration-time Curve From 0 to Infinity (AUC[0-∞] for T-DM1 Concentrations||3-Week and Weekly Cohorts: Cycle 1 Day 1 Pre-dose 30 minutes and 4 hours after the end of infusion; Cycle 1 Day 2, 3, 4, 8 (Pre-dose 30 minutes after the end of infusion) 11, 15 (Pre-dose 30 minutes after the end of infusion) and 18|Pharmacokinetic-evaluable patients were defined as patients who received at least one dose of T-DM1 with at least one post-dose concentration data point.||day • μg/mL||Standard Deviation|Mean
796549|NCT00932373|Primary|Pharmacokinetic (PK) Parameters After the First Dose: Maximum Observed Plasma Concentration Cmax for T-DM1 Concentrations||3-Week and Weekly Cohorts: Cycle 1 Day 1 Pre-dose 30 minutes and 4 hours after the end of infusion; Cycle 1 Day 2, 3, 4, 8 (Pre-dose 30 minutes after the end of infusion) 11, 15 (Pre-dose 30 minutes after the end of infusion) and 18|Pharmacokinetic-evaluable patients were defined as patients who received at least one dose of T-DM1 with at least one post-dose concentration data point.||μg/mL||Standard Deviation|Mean
796584|NCT00932620|Secondary|Changes in Low-density Lipoprotein Cholesterol (LDL-C)||3 months|||LDL-C, mg/dL||Standard Deviation|Mean
796551|NCT00932373|Primary|Number of Patients With Dose Limiting Toxicities (DLTs)|"DLT is defined as one of the following as per investigator related to study drug:
Grade ≥ 3 non-hematologic, non-hepatic major organ toxicity
Grade ≥ 3 cardiac toxicity, including cardiac troponin I elevation or any new segmental wall abnormality as determined by non-invasive cardiac imaging
Grade ≥ 4 thrombocytopenia
Grade ≥ 4 neutropenia (absolute neutrophil count < 500/μ L) lasting > 4 days or accompanied by fever
Grade ≥ 4 anemia
Grade ≥ 3 serum bilirubin, hepatic transaminase (alanine aminotransferase or aspartate aminotransferase), or alkaline phosphatase For patients with Grade 2 hepatic transaminase or alkaline phosphatase levels at baseline as a result of liver metastases or bone metastases, a hepatic transaminase or alkaline phosphatase level ≥ 10 times the upper limit of normal will be considered a DLT.
Weekly cohorts only: Toxicity preventing retreatment on Cycle 1, Day 8 or toxicity preventing re-treatment on Cycle 1, Days 15 and Day 22"|A minimum of 21 days after first dose of trastuzumab-MCC-DM1|Safety Population included all treated patients||participants|||Number
796552|NCT00932373|Secondary|Percentage of Participants With Anti-therapeutic Antibodies to Trastuzumab Emtansine|After the start of trastuzumab emtansine treatment, serum samples were collected every 3 weeks prior to trastuzumab emtansine dosing for detection of anti-therapeutic antibodies using a validated assay. A bridging antibody electrochemiluminescence assay (ECLA) was used to detect antibodies to trastuzumab emtansine. The assay utilized trastuzumab emtansine conjugated to biotin and a ruthenium label to form a complex with anti-trastuzumab emtansine antibodies. The antibody complex was captured by streptavidin-coated paramagnetic beads.|Baseline to the end of the study (up to 3 years 2 months)|||percentage of participants|||Number
796553|NCT00932373|Secondary|Progression-free Survival|Progression-free survival was defined as the time from first dose of trastuzumab emtansine to documented disease progression or death from any cause within 30 days of the last dose of trastuzumab emtansine, whichever occurred earlier. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter of target lesions recorded since treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|Baseline to the end of the study (up to 3 years 2 months)|Efficacy population: All enrolled participants who received treatment.||Months||95% Confidence Interval|Median
796554|NCT00932373|Secondary|Duration of Objective Response|Duration of objective response was defined as the time from the initial response to disease progression or death from any cause within 30 days of the last dose of trastuzumab emtansine.|Baseline to the end of the study (up to 3 years 2 months)|Efficacy population: All enrolled participants who received treatment.||Months||95% Confidence Interval|Median
796555|NCT00932373|Secondary|Percentage of Participants With an Objective Response|The occurrence of an objective response was determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST). An objective response was defined as a complete response or a partial response as determined on 2 consecutive occasions ≥ 4 weeks apart. A complete response was defined as the disappearance of all target lesions or the disappearance of all non-target lesions and normalization of tumor marker level. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameter of target lesions.|Baseline to the end of the study (up to 3 years 2 months)|Efficacy population: All enrolled participants who received treatment.||percentage of participants|||Number
796556|NCT00932373|Primary|Percentage of Participants With Adverse Events (AE), Serious Adverse Events (SAE), AEs With Grade >=3, and AEs Related To Treatment|"The time frame for AEs is study treatment initiation until 30 days after last administration of study treatment or at the time of initiation of another anti-cancer therapy, which ever occurs first.
The time frame for SAEs is study treatment initiation until 90 days after last administration of study treatment or at the time of initiation of another anti-cancer therapy, which ever occurs first."|Study treatment initiation until 30 or 90 days after last administration of study treatment|Safety-evaluable population: All participants who received at least 1 dose of trastuzumab-MCC-DM1||percentage of participants|||Number
796557|NCT00932399|Primary|% Weight Change From Baseline|Time window for 3 years is 31-39 months after baseline|At ~3 years after baseline|||% weight change||95% Confidence Interval|Mean
796558|NCT00932425|Primary|Completion of Assigned Monitoring as a Measure of Feasibility|Feasibility criteria included more than 70% completion of cardiac monitoring if applicable. Patients in the Monitoring arm were assigned to wear a Cardionet mobile cardiac outpatient telemetry monitor for 21 days. Outpatient monitoring began 22 days (+/- 12 days) after symptom onset.|21 days|Only patients in the monitoring arm were assessed for compliance with assigned monitoring||participants|||Number
796559|NCT00932425|Secondary|Recurrent Stroke or TIA|Patients and their primary physicians or neurologists were contacted at 3 months and 1 year after discharge and reported clinical diagnoses of recurrent stroke or TIA using validated questionnaires. Reported events were verified by review of relevant medical records.|1 year|||participants|||Number
796560|NCT00932425|Secondary|Diagnosis of Atrial Fibrillation||1 year|2 participants in the Control arm were followed for less than 90 days||participants|||Number
796561|NCT00932425|Secondary|Diagnosis of Atrial Fibrillation||90 days|2 patients in the control arm did not have a full 90 days of assessment (see Participant Flow)||participants|||Number
796562|NCT00932425|Primary|Completion of Clinical Follow-up as a Measure of Feasibility|Feasibility was defined as 90% or more of randomized patients completing full clinical follow-up and 70% or more completion of assigned cardiac monitoring if applicable|1 year|||participants|||Number
796563|NCT00932451|Primary|Percentage of Participants With Adverse Events|Incidence of adverse events and laboratory abnormalities (severity graded by the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], version 4.0).|6 years|The safety analysis population included all participants who were enrolled and received at least 1 dose of study medication (excluding day-7 pharmacokinetic [PK] dosing).||Percentage of Participants|||Number
796564|NCT00932451|Primary|Objective Response Rate|The objective response rate (ORR) as a measure of anti-tumor efficacy of oral PF-02341066 in participants with advanced NSCLC with an ALK gene translocation or inversion after failure of at least one line of chemotherapy.|6 years|Response-evaluable populations: defined as participants in either the SA-ALK positive by IUO population or SA-ALK positive by non-IUO population, respectively, who had adequate baseline tumor assessment.||Percentage of participants||95% Confidence Interval|Number
796585|NCT00932620|Primary|Changes in Small Dense Low-density Lipoprotein Cholesterol (sdLDL-C) Levels||Baseline and 3 months|||sdLDL-C, mg/dL||Standard Deviation|Mean
796565|NCT00932451|Secondary|Patient Reported Outcomes (PROs) of Health-related Quality of Life (HRQoL): Mean Change From Baseline of EQ-5D Visual Analog Score (VAS) Scale|The EQ-5D descriptive system measured a patient’s health state on 5 dimensions which included: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The respondent’s self-rated health was assessed on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state) by the EQ-VAS. n is the number of participants who completed the scale at baseline and at the respective Cycle.|6 years|The PRO evaluable population was defined as the participants from the SA population who completed a baseline assessment and at least one post-baseline assessment.||Units on a scale||Standard Deviation|Mean
796566|NCT00932451|Secondary|Percentage of Participants With Visual Symptom Assessment Questionnaire (VSAQ-ALK)|"The participants who responded to the question: Have you experienced any visual disturbances? Only the participants who answered yes were instructed to complete the rest of the questionnaire. N was the number of participants who had completed the first question."|6 years|The safety analysis population included all participants who were enrolled and received at least 1 dose of study medication (excluding day-7 pharmacokinetic [PK] dosing).||Percentage of participants|||Number
796567|NCT00932451|Secondary|Mean Change From Baseline of QLQ-LC13 Scale Scores|The QLQ-LC13 consists of 1 multi-item scale and 9 single items that assess specific symptoms (dyspnoea, cough, hemoptysis, and site-specific pain), side effects (sore mouth, dysphagia, neuropathy, and alopecia), and pain medication use of lung cancer patients. n is the number of participants who completed the scale at baseline and at the respective Cycle. The subscales of the EORTC QLQ-LC13 were scored based on the EORTC scoring manual. The transformed scores range from 0-100. Higher scores indicate higher (“worse”) symptom severity, higher (“better”) functioning, and better global QoL. Negative change from Baseline scores indicate an improvement in symptoms, decreased functioning, or decreased QoL, while positive change scores indicate an increase in functioning, increased QoL, or deterioration in symptoms.|6 years|The PRO evaluable population was defined as the participants from the SA population who completed a baseline assessment and at least one post-baseline assessment.||Units on a scale||Standard Deviation|Mean
796568|NCT00932451|Secondary|Mean Change From Baseline of EORTC QLQ-C30 Functional and Symptom Scale Scores|The EORTC QLQ-C30 consists of 30 questions which assess five functional domains (physical, role, cognitive, emotional, and social), global health status/quality of life, disease/treatment related symptoms (fatigue, pain, nausea/vomiting, dyspnoea, appetite loss, sleep disturbance, constipation, and diarrhoea), and the perceived financial impact of disease. n is the number of participants who completed the scale at baseline and at the respective Cycle. The subscales of the EORTC QLQ-C30 were scored based on the EORTC scoring manual. The transformed scores range from 0-100. Higher scores indicate higher (“worse”) symptom severity, higher (“better”) functioning, and better global QoL. Negative change from Baseline scores indicate an improvement in symptoms, decreased functioning, or decreased QoL, while positive change scores indicate an increase in functioning, increased QoL, or deterioration in symptoms.|6 years|The PRO evaluable population was defined as the participants from the SA population who completed a baseline assessment and at least one post-baseline assessment.||Units on a scale||Standard Deviation|Mean
796569|NCT00932451|Secondary|Mean Change From Baseline in QLQ-C30 Global Quality of Life Scores.|The EORTC QLQ-C30 consists of 30 questions which assess five functional domains (physical, role, cognitive, emotional, and social), global health status/quality of life, disease/treatment related symptoms (fatigue, pain, nausea/vomiting, dyspnea, appetite loss, sleep disturbance, constipation, and diarrhoea), and the perceived financial impact of disease. n is the number of participants who completed the scale at baseline and at the respective Cycle. The subscales of the EORTC QLQ-C30 were scored based on the EORTC scoring manual. The transformed scores range from 0-100. Higher scores indicate higher (“worse”) symptom severity, higher (“better”) functioning, and better global QoL. Negative change from Baseline scores indicate an improvement in symptoms, decreased functioning, or decreased QoL, while positive change scores indicate an increase in functioning, increased QoL, or deterioration in symptoms.|6 years|The patient reported outcomes (PRO) evaluable population was defined as the participants from the safety analysis (SA) population who completed a baseline assessment and at least one post-baseline assessment.||Units on a scale||Standard Deviation|Mean
796570|NCT00932451|Secondary|QTc Prolongation in Participants|The percentage of participants with maximum post-dose QTcF/QTcB (<450, 450 - <480, 480 - <500, and ≥500 msec) were evaluated.|6 years|Participants from the SA population who had a Baseline (last ECG [electrocardiogram] prior to Cycle 1 Day 1 dose) and ≥1 post Baseline ECG measurement and were not included in the ECG sub-study.||Percentage of participants|||Number
796571|NCT00932451|Secondary|Genotypes of Alleles Possibly Associated With Adverse Hepatic Drug Reactions (Pharmacogenomic Evaluable Population)|The frequency of the candidate gene alleles, HLA-DQA1*02:01, HLA-DQB1*02:02, HLA-DRB1*07:01 and TNXB/rs12153855, were measured in alanine transaminase (ALT) Cases and ALT Controls to evaluate if there were statistically significant associations that would support or suggest any predictive (ie, diagnostic) value of these markers in identifying participants who were at increased risk for hepatic toxicity. The frequency of 2 additional HLA gene alleles, HLA-B*57:01 and HLA-DRB1*15:01, were also measured in ALT Cases and ALT Controls. ALT Cases are defined as those patients with a baseline ALT of ≤1xULN and at least one on-treatment ALT assessment of >3x upper limit of normal (ULN), and ALT Controls represent those patients with baseline and on-treatment assessments of ALT of ≤1xULN.|6 years|The All Genotyped Population was defined as all participants in the safety analysis population who had at least 1 genotype result. The Pharmacogenomic Evaluable (PE) Population was defined as participants in the All Genotyped Population who had an HLA genotype result and were designated as an ALT Case or Control.||Percentage of participants|||Number
796586|NCT00932646|Secondary|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG|Clinical relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsenings of baseline conditions were reported as Adverse Events related to treatment (cardiac disorders and investigations).|6 weeks|||participants|||Number
796616|NCT00933244|Other Pre-specified|Muscle Function: One Year Change in Timed Up and Go Test, Five Sit-to-Stand Test|We summarized within-arm one-year changes in continuous muscle outcomes using the mean (95% confidence interval).|1 Year|4% of subjects withdrew from the study and muscle tests were not conducted in four additional subjects who sustained injury or reported leg pain during a study visit. Thus the number analyzed is less than the number randomized into the trial.||seconds||95% Confidence Interval|Mean
796572|NCT00932451|Secondary|Molecular Profiling (ALK Status) Descriptive Statistics for ALK Percentage of Positive Cells by Central Laboratory Test (SA [ALK Positive by IUO] Population)|Molecular profiling outcomes included:Types of EML4-ALK fusion variants and ALK protein expression; Although a secondary objective was defined to explore the relationship of ALK gene fusion to the presence of ALK protein and fusion transcript, no additional analyses of ALK fusion variants or ALK protein were performed for technical reasons. Analyses of change from Baseline in the expression of biomarkers relevant to signaling pathways were not performed because paired Baseline and on-treatment (Cycle 2) tumor tissue required for the analysis, which were to be collected on an optional basis, were not available.|6 years|The safety analysis population included all participants who received at least 1 dose of study medication (excluding day-7 pharmacokinetic [PK] dosing) and were ALK positive by IUO (SA-ALK positive by IUO population)||Percentage of cells||Full Range|Median
796573|NCT00932451|Secondary|Plasma Concentrations of Crizotinib (PF-02341066) and Its Metabolite PF-06260182|Plasma concentrations of crizotinib (PF-02341066) and its metabolite PF-06260182. The method of dispersion is % coefficient of variation.|6 years|All participants who have ≥ 1 measurement of PF-02341066 or PF-06260182 at the time of reporting are included in PK analysis. Concentration at Cycle 2 Day 1 and beyond are considered steady state, and only included those who received at least 14 continuous days of 250 mg BID dosing.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
796574|NCT00932451|Secondary|Probability of Survival|Six-month and 1-year survival probabilities were defined as the probabilities of survival at 6 months and 1 year, respectively, after the date of the Cycle 1 Day 1 dose based on the Kaplan-Meier estimate.|6 years|The safety analysis populations included all participants who received at least 1 dose of study medication (excluding day-7 pharmacokinetic [PK] dosing), and were ALK positive either by IUO (SA-ALK positive by IUO population) or by non-IUO (SA-ALK positive by non-IUO population), respectively.||Percentage of probability||95% Confidence Interval|Number
796575|NCT00932451|Secondary|Overall Survival (OS)|OS was defined as the time from the Cycle 1 Day 1 dose to the date of death due to any cause. OS (in months) was calculated as (date of death − date of Cycle 1 Day 1 dose + 1)/30.4.|6 years|The safety analysis populations included all participants who received at least 1 dose of study medication (excluding day-7 pharmacokinetic [PK] dosing), and were ALK positive either by IUO (SA-ALK positive by IUO population) or by non-IUO (SA-ALK positive by non-IUO population), respectively.||Months||95% Confidence Interval|Median
796576|NCT00932451|Secondary|Progression Free Survival (PFS)|PFS was defined as the time from the date of the Cycle 1 Day 1 dose to the date of the first documentation of objective tumor progression or death on study due to any cause, whichever occurred first.|6 years|The safety analysis populations included all participants who received at least 1 dose of study medication (excluding day-7 pharmacokinetic [PK] dosing), and were ALK positive either by IUO (SA-ALK positive by IUO population) or by non-IUO (SA-ALK positive by non-IUO population), respectively.||Months||95% Confidence Interval|Median
796577|NCT00932451|Secondary|Disease Control Rate (DCR)|DCR at 6 and 12 weeks was defined as the percentage of participants with a confirmed CR, confirmed PR, or SD (according to RECIST v 1.1) at 6 weeks and 12 weeks, respectively.|6 years|Response-evaluable populations: defined as participants in either the SA-ALK positive by IUO population or SA-ALK positive by non-IUO population, respectively, who had adequate baseline tumor assessment.||Percentage of participants||95% Confidence Interval|Number
796578|NCT00932451|Secondary|Time to Tumor Response (TTR)|TTR was defined as the time (in weeks) from the date of Cycle 1 Day 1 dose to first documentation of objective tumor response (CR or PR) that was subsequently confirmed. For participants proceeding from PR to CR, the onset of PR was taken as the onset of response.|6 years|Response-evaluable populations: defined as participants in either the SA-ALK positive by IUO population or SA-ALK positive by non-IUO population, respectively, who had adequate baseline tumor assessment.||Weeks||Full Range|Median
796579|NCT00932451|Secondary|Duration of Response (DR)|DR was defined as the time from the first documentation of objective tumor response (CR or PR) that was subsequently confirmed, to the first documentation of objective tumor progression or to death on study due to any cause, whichever occurred first. DR (in months) was calculated as (first date of PD or death − first date of CR or PR that was subsequently confirmed + 1)/30.4.|6 years|Response-evaluable populations: defined as participants in either the SA-ALK positive by IUO population or SA-ALK positive by non-IUO population, respectively, who had adequate baseline tumor assessment.||Months||95% Confidence Interval|Median
796580|NCT00932477|Secondary|The Number of Ophthalmic Adverse Events at 1 Week|The number of ophthalmic adverse events (AE) at 1 week. An ophthalmic AE is any unfavorable and unintended sign, symptom, or disease related to the eye which occurs during the use of the study investigational product|1 Week|Safety population, which consisted of all patients who started the study (randomized) and received treatment.||Number of adverse events|||Number
796581|NCT00932477|Secondary|Best-Corrected Visual Acuity (BCVA) Status at 1 Week|"BCVA status at 1 week reported as the number of patients whose scores were either Better, No Change, or Worse than their scores at baseline. The status was tabulated as number of lines read correctly at 1 week minus the number of lines read correctly at baseline. Better equals increase of 2 lines or more in at least 1 eye; No Change equals change between -2 to +2 lines in either eye; Worse equals decrease of 2 lines or more in at least 1 eye. BCVA is measured using a special eye chart and is reported as the number of lines (5 letters per line) read correctly."|1 Week|Safety population, which consisted of all patients who started the study (randomized) and received treatment.||Number of Patients|||Number
796582|NCT00932477|Secondary|Number of Patients With at Least One Severity Grade Increase in Biomicroscopy Findings at 1 Week|Number of patients with at least one severity grade increase in biomicroscopy findings at 1 week. Eyes are examined with a special microscope (biomicroscopy), and findings scored using a 5-point scale (0=none, +0.5=trace, +1=mild, +2=moderate, +3=severe). An increase in severity grade indicates worsening.|1 Week|Safety population, which consisted of all patients who started the study (randomized) and received treatment.||Number of Patients|||Number
796583|NCT00932477|Primary|Tolerability Questionnaire Mean Scores at 1 Week|Tolerability Questionnaire mean scores at 1 week. The Tolerability Questionnaire includes 8 tolerability questions on selected performance measures. All questions are scored based on continuous visual analog scale from 0-100. The first 4 questions presented measure increasing tolerability where 0=worst and 100=best. The second set of 4 questions presented measure decreasing tolerability where 0=best and 100=worst.|1 Week|Safety population, which consisted of all patients who started the study (randomized) and received treatment.||Scores on a scale||Standard Deviation|Mean
796587|NCT00932646|Primary|FEV1 Area Under Curve 12-24h (AUC 12-24h) Response After Six Weeks of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed in the morning of the first treatment visit, just prior to administration of the morning dose of randomized treatment. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FEV1 AUC 12-24h was calculated from 12-24 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 h and 10 min prior to am dose on the first day of treatment (baseline) and 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment|Full analysis set (FAS).||Liter||Standard Error|Least Squares Mean
796588|NCT00932646|Secondary|Trough FVC Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Trough values were obtained 30 minutes prior to the last am dose of study drug after six weeks of treatment . Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random.|Baseline and 6 weeks|FAS||Liter||Standard Error|Least Squares Mean
796589|NCT00932646|Secondary|Peak FVC (0-3h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Peak FVC was obtained within 0 - 3 hours after the last am dose of study drug after 6 weeks of treatment. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random.|Baseline and 6 weeks|FAS||Liter||Standard Error|Least Squares Mean
796590|NCT00932646|Secondary|FVC Area Under Curve 0-24 Hours (AUC 0-24h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FVC AUC 0-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 h and 10 min prior to am dose on the first day of treatment (baseline) and -30 min, 30 min, 60 min, 2h, 3h, 4h, 6h, 8h, 10h, 11 hr 50 min,12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment.|FAS||Liter||Standard Error|Least Squares Mean
796591|NCT00932646|Secondary|FVC Area Under Curve 12-24 Hours (AUC 12-24h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FVC AUC 12-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 h and 10 min prior to am dose on the first day of treatment (baseline) and 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment|FAS||Liter||Standard Error|Least Squares Mean
796592|NCT00932646|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-12 Hours (AUC 0-12h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FVC AUC 0-12h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to am dose on the first day of treatment (baseline) and -30 min (zero time), 30 min, 60 min, 2 hour (h) , 3 h, 4 h, 6 h, 8 h, 10 h, 11 h 50 min relative to am dose after six weeks of treatment|FAS||Liter||Standard Error|Least Squares Mean
796593|NCT00932646|Secondary|Trough FEV1 Response|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Trough values were obtained 30 minutes prior to the last am dose of study drug after six weeks of treatment . Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random.|Baseline and 6 weeks|FAS||Liter||Standard Error|Least Squares Mean
796594|NCT00932646|Secondary|Peak FEV1 (0-3h) Response|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Peak values were obtained within 0 - 3 hours after the last am dose after six weeks of treatment. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random.|Baseline and 6 weeks|FAS||Liter||Standard Error|Least Squares Mean
796595|NCT00932646|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response After Six Weeks of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FEV1 AUC 0-3h was calculated from 0-3hours post-dose using the trapezoidal rule, divided by the observation time (3 h) to report in litres.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -30 min, 30 min, 60 min, 2 h , 3 h, relative to am dose after six weeks of treatment|FAS||Liter||Standard Error|Least Squares Mean
796596|NCT00932646|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-24 h (AUC 0-24h) Response After Six Weeks of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random.FEV1 AUC 0-24h was calculated from 0-24 hours post-dose using the trapezoidal rule, divided by the observation time (24h) to report in litres.|1 h and 10 min prior to am dose on the first day of the treatment (baseline) and -30 min, 30 min, 60 min, 2h, 3h, 4h, 6h, 8h, 10h, 11 hr 50 min,12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment.|FAS||Liter||Standard Error|Least Squares Mean
796606|NCT00932893|Secondary|Plasma Concentration of Crizotinib|Only participants receiving crizotinib were to be analyzed for this outcome measure as per planned analysis.|Pre-dose on Cycle 1 Day 1, Cycle 1 Day 15, and Day 1 of Cycles 2, 3, 5|"Pharmacokinetic (PK) analysis population included all randomized participants who received at least 1 dose of study treatment and had 1 of the PK parameters of interest. Here N (number of participants analyzed) signifies participants evaluable for this measure. n=participants evaluable at specific time points."||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
797050|NCT00937040|Secondary|Responder Rate Using AISRS|AISRS responder rate is defined as the percentage of subjects with AISRS < 18 at endpoint.|Endpoint (42 days or early discontinuation)|Intent-to-Treat (ITT) analysis set||Percent of participants|||Number
796597|NCT00932646|Primary|FEV1 Area Under Curve 0-12 h (AUC 0-12h) Response After Six Weeks of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed in the morning of the first treatment visit, just prior to administration of the morning dose of randomized treatment. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FEV1 AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 hour (h) and 10 minutes (min) prior to am dose on the first day of treatment (baseline) and -30 min (zero time), 30 min, 60 min, 2 hour (h) , 3 h, 4 h, 6 h, 8 h, 10 h, 11 h 50 min relative to am dose after six weeks of treatment|Full analysis set (FAS). FAS is defined as all patients with the baseline (pre-dose) date and any evaluable post-dosing data for the first co-primary endpoint FEV1AUC 0-12h.||Liter||Standard Error|Least Squares Mean
796598|NCT00932659|Secondary|Number of Participants Experiencing a Peridialytic or Intradialytic Arrhythmias||6 months|all participants included||participants|||Number
796599|NCT00932659|Primary|Number of Participants With a Significant Arrhythmia Detected||6 months|All patients enrolled were analyzed in this observational study.||participants|||Number
796600|NCT00932893|Secondary|European Quality of Life - 5 Dimensional (EQ-5D) Visual Analog Scale (VAS)|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.|Baseline, Day 1 of each cycle until disease progression, end of treatment (up to 112 weeks)|FAS included all participants who were randomized to study treatment. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants who were evaluable for specified time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
796601|NCT00932893|Secondary|European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Supplement Module for Lung Cancer (EORTC QLQ-LC13)|QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, other pain, and medicine for pain). Recall period: past week; response range: 1 'Not at All' to 4 'Very Much'. Scores averaged, transformed to 0-100 scale; higher symptom score = greater degree of symptoms.|Baseline, Day 1 of each cycle until disease progression, end of treatment (up to 112 weeks)|FAS included all participants who were randomized to study treatment. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants who were evaluable for specified time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
796602|NCT00932893|Secondary|European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)|EORTC QLQ-C30: included global health status/quality of life (QoL), functional scales (physical, role, cognitive, emotional, and social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulties). Most questions used 4- point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score for Global Qol/functional scales=better level of QoL/functioning or higher score for symptom scale=greater degree of symptoms.|Baseline, Day (D) 1 of each cycle (C) until disease progression, end of treatment (EOT, up to 112 weeks)|FAS included all participants who were randomized to study treatment. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants who were evaluable for specified time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
796603|NCT00932893|Secondary|Time to Deterioration (TTD) in Participant Reported Pain, Dyspnea, and Cough|TTD in pain (pain in chest from European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Supplement Module for Lung Cancer [EORTC QLQ-LC13]), dyspnea (from EORTC QLQ-LC13), or cough (from EORTC QLQ-LC13) symptoms was defined as the time from randomization to the earliest time the participant's score showed a 10 point or higher increase from baseline in any of the three symptoms from the instrument. The transformed score of pain, dyspnea, and cough symptom scales of EORTC QLQ-LC13 range from 0 to 100, greater scores = higher symptom severity.|Baseline up to end of treatment (up to 112 weeks)|Patient Reported Outcome (PRO) evaluable population included all randomized participants who received at least 1 dose of study treatment, and had a baseline and at least 1 post-baseline PRO assessment.||months||95% Confidence Interval|Median
796604|NCT00932893|Secondary|Plasma Concentration of Soluble c-Met Ectodomain and Hepatocyte Growth Factor Scatter Proteins|Descriptive statistics (absolute value and change from baseline as measured by ratio to baseline) for each best overall response category (CR, PR, SD, PD or combined) have been used to summarize the data from optional soluble c-Met ectodomain assays for crizotinib treated patients.|Pre-dose on Day 1 of Cycle 1, 2 to 6 hours post-dose on Day 1 of Cycle 2, end of treatment (up to 112 weeks)|The soluble biomarker-evaluable population includes patients from the SA population that received PF-02341066, who have an optional blood sample prior to dosing on Cycle 1 Day 1 and have at least 1 on-treatment soluble biomarker evaluation (Cycle 2 Day 1 and/or end of treatment).||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
796605|NCT00932893|Secondary|Number of Participants With Categorical Maximum QTcF for Crizotinib|QT interval corrected using Fridericia’s formula (QTcF): QT interval (time corresponding to the beginning of depolarization to re-polarization of the ventricles) divided by cube root of RR interval. Maximum QTcF was categorized as less than (<) 450 milliseconds (msec), 450 msec to <480 msec, 480 msec to <500 msec, and more than or equal to (>=) 500 msec. A participant is reported only once under the maximum QTcF interval observed at any of the time-points. Only participants receiving crizotinib were to be analyzed for this outcome measure as per planned analysis.|Pre-dose on Day 1 of Cycle 1, 2 to 6 hours post-dose on Day 1 of Cycle 1, 2|ECG-evaluable population included all randomized participants who received at least 1 dose of study treatment, and had a baseline and at least 1 post-baseline ECG measurement.||participants|||Number
796694|NCT00933270|Secondary|Stent Fracture Rate|Stent fractures were analyzed by X-ray evaluation by a designated core laboratory and defined as type I, II, III, IV or V.|24 months (± 30 Days)|Per ITT set: Supera implanted. Patient returned for visit and had x-ray of stent. X-ray analyzed by core lab||percentage of participants|||Number
796607|NCT00932893|Secondary|Time to Tumor Response (TTR)|Time from date of randomization to first documentation of objective tumor response. TTR was calculated for the subgroup of participants with objective tumor response. Objective tumor response was defined as CR or PR according to RECIST v1.1. CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (<10 mm short axis). PR: at least 30 % decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits.|Randomization until PD or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks)|FAS included all participants who were randomized to study treatment. Here 'N' (number of participant analyzed) signifies participants with objective tumor response.||weeks||Full Range|Median
796608|NCT00932893|Secondary|Duration of Response (DR)|Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7.02. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Randomization until PD or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks)|FAS included all participants who were randomized to study treatment. Here 'N' (number of participant analyzed) signifies participants with objective tumor response.||weeks||95% Confidence Interval|Median
796609|NCT00932893|Secondary|Percentage of Participants With Disease Control at Week 12|Disease control: participants with CR, PR, or SD according to RECIST v1.1. CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (<10 mm short axis). PR: at least 30 % decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.|Week 12|FAS included all participants who were randomized to study treatment.||percentage of participants||95% Confidence Interval|Number
796610|NCT00932893|Secondary|Percentage of Participants With Disease Control at Week 6|Disease control: participants with CR, PR, or stable disease (SD) according to RECIST v1.1. CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (<10 mm short axis). PR: at least 30 % decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. Disease control is based on independent radiology review.|Week 6|FAS included all participants who were randomized to study treatment.||percentage of participants||95% Confidence Interval|Number
796611|NCT00932893|Secondary|Percentage of Participants With Objective Response (OR)|Percentage of participants with objective response based on assessment of complete response (CR) or partial response (PR) according to RECIST v1.1. CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (<10 millimeter [mm] short axis). PR: at least 30 percent (%) decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. Objective response is based on independent radiology review.|Randomization until PD or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks)|FAS included all participants who were randomized to study treatment.||percentage of participants||95% Confidence Interval|Number
796612|NCT00932893|Secondary|Overall Survival Probability at Months 6 and 12|Overall survival probability at Month 6 and 12 was defined as the probability of survival at 6 and 12 months respectively, after the randomization of study treatment. The survival probability was estimated using the Kaplan-Meier method.|Month 6, 12|FAS included all participants who were randomized to study treatment.||percent chance of survival||95% Confidence Interval|Number
796613|NCT00932893|Secondary|Overall Survival (OS)|OS: Time in months from randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 30.4.|Randomization until death (up to 4.5 years)|FAS included all participants who were randomized to study treatment.||months||95% Confidence Interval|Median
796614|NCT00932893|Primary|Progression-Free Survival (PFS)|PFS: Time in months from randomization to first documentation of objective disease progression as determined by independent radiology review or to death due to any cause, whichever occurred first. PFS was calculated as (first event date minus the date of randomization plus 1) divided by 30.4. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria version 1.1 (RECIST v1.1), as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.|Randomization until progressive disease (PD) or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks)|Full analysis set (FAS) included all participants who were randomized to study treatment.||months||95% Confidence Interval|Median
796615|NCT00933166|Primary|Comfort After Insertion|Comfort after insertion (30 seconds to 1 minute) as interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of three months' wear time. Comfort after insertion was measured on a 10-point scale, with 1 being poor and 10 being excellent.|3 months|Analysis was per protocol and excluded ten major protocol deviations as determined by masked review. Eighteen participants discontinued prior to the Month 3 visit. Nineteen participants responded N/A due to reasons such as continual wear.||Units on a Scale||Standard Deviation|Mean
799403|NCT00947297|Primary|Rate of Adverse Events (Number of Participants Who Experienced Any AE Considered Related to Study Drug)||1 year|||participants|||Number
796617|NCT00933244|Other Pre-specified|Bone Turnover|C-telopeptide (pg/mL) was measured at baseline, 30 days, 60 days, 120 days, 365 days in the subset of subjects who arrived at all study visit fasting since midnight and had phlebotomy prior to 10 am. Data demonstrated outliers and was summarized using the median (25th, 75th interquartile range).|0, 30, 60, 120, 365 days|Bone turnover markers were analyzed in duplicate for the subset of subjects who arrived at all study visit fasting since midnight and had phlebotomy prior to 10 am.||pg/mL||Inter-Quartile Range|Median
796618|NCT00933244|Secondary|Bone Mineral Density|Annualized percent change in bone mineral density at spine, hip, femoral neck, and body|1 Year|Annual changes in bone mineral density were analyzed for subjects who completed the study. 9 subjects (4%) withdrew from the study, all for personal reasons. Thus, number of participants analyzed is 4% less than number of subjects randomized.||Percent Change in Bone Mineral Density||Inter-Quartile Range|Mean
796619|NCT00933244|Primary|Intestinal Calcium Absorption|Percent of calcium absorbed in the intestinal tract within one day|One Year|4% of subjects withdrew from the study. Additionally the calcium isotope dose was not recorded in 2 subjects and a urine sample was mishandled in a third. Thus, the number of participants analyzed is less than the number randomized into the trial.||Total Fractional Calcium Absorption||Inter-Quartile Range|Median
796620|NCT00933270|Secondary|Exercise Tolerance Test: Maximal Walking Time|Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.|12 months (± 30 Days)|Per ITT set. The denominator for exercise testing considers factors such as: patient flow to the physician performing the procedure making it difficult to get a baseline treadmill test; patients with bilateral, multilevel peripheral disease and other underlying diseases and other factors such as age could impact their ability to exercise.||seconds||Standard Deviation|Mean
796621|NCT00933270|Secondary|Exercise Tolerance Test: Maximal Walking Time|Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.|1 month (± 7 Days)|Per ITT set. The denominator for exercise testing considers factors such as: patient flow to the physician performing the procedure making it difficult to get a baseline treadmill test; patients with bilateral, multilevel peripheral disease and other underlying diseases and other factors such as age could impact their ability to exercise.||seconds||Standard Deviation|Mean
796622|NCT00933270|Secondary|Exercise Tolerance Test: Maximal Walking Time|Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.|Baseline|Per ITT set. The denominator for exercise testing considers factors such as: patient flow to the physician performing the procedure making it difficult to get a baseline treadmill test; patients with bilateral, multilevel peripheral disease and other underlying diseases and other factors such as age could impact their ability to exercise.||seconds||Standard Deviation|Mean
796623|NCT00933270|Secondary|Exercise Tolerance Test: Maximal Walking Distance|Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.|12 months (± 30 Days)|Per ITT set. The denominator for exercise testing considers factors such as: patient flow to the physician performing the procedure making it difficult to get a baseline treadmill test; patients with bilateral, multilevel peripheral disease and other underlying diseases and other factors such as age could impact their ability to exercise.||meters||Standard Deviation|Mean
796624|NCT00933270|Secondary|Exercise Tolerance Test: Maximal Walking Distance|Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.|1 month (± 7 Days)|Per ITT set. The denominator for exercise testing considers factors such as: patient flow to the physician performing the procedure making it difficult to get a baseline treadmill test; patients with bilateral, multilevel peripheral disease and other underlying diseases and other factors such as age could impact their ability to exercise.||meters||Standard Deviation|Mean
796625|NCT00933270|Secondary|Exercise Tolerance Test: Maximal Walking Distance|Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.|Baseline|Per ITT set. The denominator for exercise testing considers factors such as: patient flow to the physician performing the procedure making it difficult to get a baseline treadmill test; patients with bilateral, multilevel peripheral disease and other underlying diseases and other factors such as age could impact their ability to exercise.||meters||Standard Deviation|Mean
796626|NCT00933270|Secondary|Exercise Tolerance Test: Claudication Pain Time (CPT)|Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.|12 months (± 30 Days)|Per ITT set. The denominator for exercise testing considers factors such as: patient flow to the physician performing the procedure making it difficult to get a baseline treadmill test; patients with bilateral, multilevel peripheral disease and other underlying diseases and other factors such as age could impact their ability to exercise.||seconds||Standard Deviation|Mean
796627|NCT00933270|Secondary|Exercise Tolerance Test: Claudication Pain Time (CPT)|Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.|1 month (± 7 Days)|Per ITT set. The denominator for exercise testing considers factors such as: patient flow to the physician performing the procedure making it difficult to get a baseline treadmill test; patients with bilateral, multilevel peripheral disease and other underlying diseases and other factors such as age could impact their ability to exercise.||seconds||Standard Deviation|Mean
796628|NCT00933270|Secondary|Exercise Tolerance Test: Claudication Pain Time (CPT)|Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.|Baseline|Per ITT set. The denominator for exercise testing considers factors such as: patient flow to the physician performing the procedure making it difficult to get a baseline treadmill test; patients with bilateral, multilevel peripheral disease and other underlying diseases and other factors such as age could impact their ability to exercise.||seconds||Standard Deviation|Mean
796710|NCT00933335|Secondary|Number of Participants With a Treatment Failure|Treatment failure is defined as the occurrence of treatment withdrawal, a decision to seek additional therapy, study removal, progression, alternative therapy for lymphoma, or death.|First day of fludarabine cycle 1 to day prior to TST/I 131 TST dosimetric dose (Week -16 to Week 1); Day of TST/I 131 TST dosimetric dose to database release (Week 1 to Week 520)|ITT-Exposed Population||participants|||Number
796629|NCT00933270|Secondary|Exercise Tolerance Test: Claudication Pain Distance|Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.|12 months|Per ITT set. The denominator for exercise testing considers factors such as: patient flow to the physician performing the procedure making it difficult to get a baseline treadmill test; patients with bilateral, multilevel peripheral disease and other underlying diseases and other factors such as age could impact their ability to exercise.||meters||Standard Deviation|Mean
796630|NCT00933270|Secondary|Exercise Tolerance Test: Claudication Pain Distance|Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.|1 month (± 7 Days)|Per ITT set. The denominator for exercise testing considers factors such as: patient flow to the physician performing the procedure making it difficult to get a baseline treadmill test; patients with bilateral, multilevel peripheral disease and other underlying diseases and other factors such as age could impact their ability to exercise.||meters||Standard Deviation|Mean
796631|NCT00933270|Secondary|Exercise Tolerance Test: Claudication Pain Distance|Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.|Baseline|Per ITT set. The denominator for exercise testing considers factors such as: patient flow to the physician performing the procedure making it difficult to get a baseline treadmill test; patients with bilateral, multilevel peripheral disease and other underlying diseases and other factors such as age could impact their ability to exercise.||meters||Standard Deviation|Mean
796632|NCT00933270|Secondary|Clinical Improvement Compared With Baseline: Rutherford Becker Scale|"Clinical Improvement Compared With Baseline
Grade +3 = Markedly Improved, Grade +2 = Moderately Improved, Grade +1 = Minimally Improved, Grade 0 = No Change, Grade -1 = Mildly Worse, Grade -2 = Moderately Worsening, Grade -3 = Markedly Worsening"|36 Months (± 30 Days)|Per ITT Set. Patients are included in the Rutherford Becker Score if :They had a baseline Rutherford Becker Classification performed prior to the study procedure.They completed their visit and Rutherford Becker Classification was performed.||percentage of limbs|||Number
796633|NCT00933270|Secondary|Clinical Improvement Compared With Baseline: Rutherford Becker Scale|"Clinical Improvement Compared With Baseline
Grade +3 = Markedly Improved, Grade +2 = Moderately Improved, Grade +1 = Minimally Improved, Grade 0 = No Change, Grade -1 = Mildly Worse, Grade -2 = Moderately Worsening, Grade -3 = Markedly Worsening"|24 Months (± 30 Days)|Per ITT Set. Patients are included in the Rutherford Becker Score if :They had a baseline Rutherford Becker Classification performed prior to the study procedure.They completed their visit and Rutherford Becker Classification was performed.||percentage of limbs|||Number
796634|NCT00933270|Secondary|Clinical Improvement Compared With Baseline: Rutherford Becker Scale|"Clinical Improvement Compared With Baseline
Grade +3 = Markedly Improved, Grade +2 = Moderately Improved, Grade +1 = Minimally Improved, Grade 0 = No Change, Grade -1 = Mildly Worse, Grade -2 = Moderately Worsening, Grade -3 = Markedly Worsening"|12 Months (± 30 Days)|Per ITT Set. Patients are included in the Rutherford Becker Score if :They had a baseline Rutherford Becker Classification performed prior to the study procedure.They completed their visit and Rutherford Becker Classification was performed.||percentage of limbs|||Number
796635|NCT00933270|Secondary|Clinical Improvement Compared With Baseline: Rutherford Becker Scale|"Clinical Improvement Compared With Baseline
Grade +3 = Markedly Improved, Grade +2 = Moderately Improved, Grade +1 = Minimally Improved, Grade 0 = No Change, Grade -1 = Mildly Worse, Grade -2 = Moderately Worsening, Grade -3 = Markedly Worsening"|1 month (± 7 Days)|Per ITT Set. Patients are included in the Rutherford Becker Score if :They had a baseline Rutherford Becker Classification performed prior to the study procedure.They completed their visit and Rutherford Becker Classification was performed.||percentage of limbs|||Number
796636|NCT00933270|Secondary|Clinical Category: Rutherford Becker|"Category and Clinical Description
0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable.
Claudication is defined as a pain, cramps, fatigue, or equivalent in leg muscles occurring during walking that results from inadequate blood supply, usually due to atherosclerotic arterial obstruction."|36 Months (± 30 Days)|Per ITT Set. Patients are included in the Rutherford Becker Score if they completed their visit and Rutherford Becker Classification was performed||percentage of limbs|||Number
796637|NCT00933270|Secondary|Clinical Category: Rutherford Becker|"Category and Clinical Description
0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable.
Claudication is defined as a pain, cramps, fatigue, or equivalent in leg muscles occurring during walking that results from inadequate blood supply, usually due to atherosclerotic arterial obstruction."|24 Months (± 30 Days)|Per ITT Set. Patients are included in the Rutherford Becker Score if they completed their visit and Rutherford Becker Classification was performed||percentage of limbs|||Number
796638|NCT00933270|Secondary|Clinical Category: Rutherford Becker|"Category and Clinical Description
0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable.
Claudication is defined as a pain, cramps, fatigue, or equivalent in leg muscles occurring during walking that results from inadequate blood supply, usually due to atherosclerotic arterial obstruction."|12 Months (± 30 Days)|Per ITT Set. Patients are included in the Rutherford Becker Score if they completed their visit and Rutherford Becker Classification was performed||percentage of limbs|||Number
796651|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Social Limitation|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|6 months (± 14 Days)|"Per ITT set.
Patients are included in the QoL endpoint if:
They completed the follow-up visit and the PAQ Questionnaire at the visit"||units on a scale||Standard Deviation|Mean
796639|NCT00933270|Secondary|Clinical Category: Rutherford Becker|"Category and Clinical Description
0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable.
Claudication is defined as a pain, cramps, fatigue, or equivalent in leg muscles occurring during walking that results from inadequate blood supply, usually due to atherosclerotic arterial obstruction."|1 Month (± 7 Days)|Per ITT Set. Patients are included in the Rutherford Becker Score if they completed their visit and Rutherford Becker Classification was performed||percentage of limbs|||Number
796640|NCT00933270|Secondary|Clinical Category: Rutherford Becker|"Category and Clinical Description
0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable.
Claudication is defined as a pain, cramps, fatigue, or equivalent in leg muscles occurring during walking that results from inadequate blood supply, usually due to atherosclerotic arterial obstruction."|Baseline|Per ITT Set. Patients are included in the Rutherford Becker Score if the Rutherford Becker Classification was performed prior to the Study procedure.||percentage of limbs|||Number
796641|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Summary Score|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|12 months (± 30 Days)|"Per ITT set.
Patients are included in the QoL endpoint if:
They completed the follow-up visit and the PAQ Questionnaire at the visit"||units on a scale||Standard Deviation|Mean
796642|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Summary Score|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|6 months (± 14 Days)|"Per ITT set.
Patients are included in the QoL endpoint if:
They completed the follow-up visit and the PAQ Questionnaire at the visit"||units on a scale||Standard Deviation|Mean
796643|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Summary Score|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|Baseline|"Per ITT set.
Patients are included in the QoL endpoint if:
They completed the PAQ Questionnaire prior to the study procedure"||units on a scale||Standard Deviation|Mean
796644|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Quality of Life|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|12 months (± 30 Days)|"Per ITT set.
Patients are included in the QoL endpoint if:
They completed the follow-up visit and the PAQ Questionnaire at the visit"||units on a scale||Standard Deviation|Mean
796645|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Quality of Life|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|6 months (± 14 Days)|"Per ITT set.
Patients are included in the QoL endpoint if:
They completed the follow-up visit and the PAQ Questionnaire at the visit"||units on a scale||Standard Deviation|Mean
796646|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Quality of Life|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|Baseline|"Per ITT set.
Patients are included in the QoL endpoint if:
They completed the PAQ Questionnaire prior to the study procedure"||units on a scale||Standard Deviation|Mean
796647|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Treatment Satisfaction|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|12 months (± 30 Days)|"Per ITT set.
Patients are included in the QoL endpoint if:
They completed the follow-up visit and the PAQ Questionnaire at the visit"||units on a scale||Standard Deviation|Mean
796648|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Treatment Satisfaction|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|6 months (± 14 Days)|"Per ITT set.
Patients are included in the QoL endpoint if:
They completed the follow-up visit and the PAQ Questionnaire at the visit"||units on a scale||Standard Deviation|Mean
796649|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Treatment Satisfaction|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|Baseline|"Per ITT set.
Patients are included in the QoL endpoint if:
They completed the PAQ Questionnaire prior to the study procedure"||units on a scale||Standard Deviation|Mean
796650|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Social Limitation|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|12 months (± 30 Days)|"Per ITT set.
Patients are included in the QoL endpoint if:
They completed the follow-up visit and the PAQ Questionnaire at the visit"||units on a scale||Standard Deviation|Mean
799485|NCT00947791|Secondary|Young Mania Rating Scale (YMRS)||24 hrs post-infusion compared to baseline|Based on confidentiality concerns, 0 participants analyzed.|||||
796652|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Social Limitation|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|Baseline|"Per ITT set.
Patients are included in the QoL endpoint if:
They completed the PAQ Questionnaire prior to the study procedure"||units on a scale||Standard Deviation|Mean
796653|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Symptom Stability|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|12 months (± 30 Days)|"Per ITT set.
Patients are included in the QoL endpoint if:
They completed the follow-up visit and the PAQ Questionnaire at the visit"||units on a scale||Standard Deviation|Mean
796654|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Symptom Stability|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|6 months (± 14 Days)|"Per ITT set.
Patients are included in the QoL endpoint if:
They completed the follow-up visit and the PAQ Questionnaire at the visit"||units on a scale||Standard Deviation|Mean
796655|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Symptom Stability|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|Baseline|"Per ITT set.
Patients are included in the QoL endpoint if:
They completed the PAQ Questionnaire prior to the study procedure"||units on a scale||Standard Deviation|Mean
796656|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Symptoms|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|12 months (± 30 Days)|"Per ITT set.
Patients are included in the QoL endpoint if:
They completed the follow-up visit and the PAQ Questionnaire at the visit"||units on a scale||Standard Deviation|Mean
796657|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Symptoms|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|6 months (± 14 Days)|"Per ITT set.
Patients are included in the QoL endpoint if:
They completed the follow-up visit and the PAQ Questionnaire at the visit"||units on a scale||Standard Deviation|Mean
796658|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Symptoms|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|Baseline|"Per ITT set.
Patients are included in the QoL endpoint if:
They completed the PAQ Questionnaire prior to the study procedure"||units on a scale||Standard Deviation|Mean
796659|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Physical Limitation|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|12 months (± 30 Days)|"Per ITT set.
Patients are included in the QoL endpoint if:
They completed the follow-up visit and the PAQ Questionnaire at the visit"||units on a scale||Standard Deviation|Mean
796660|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Physical Limitation|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|6 months (± 14 Days)|"Per ITT set.
Patients are included in the QoL endpoint if:
They completed the follow-up visit and the PAQ Questionnaire at the visit"||units on a scale||Standard Deviation|Mean
796661|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Physical Limitation|The PAQ assesses Peripheral arterial disease (PAD)-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|Baseline|"Per ITT set.
Patients are included in the QoL endpoint if:
They completed the PAQ Questionnaire prior to the study procedure"||units on a scale||Standard Deviation|Mean
796662|NCT00933270|Secondary|Quality of Life Assessed by SF-12 Questionnaire|The Medical Outcomes Study 12-Item Short form survey (SF-12) was used to assess generic QoL.SF-12 Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. Physical and mental summary scores from the SF-12 are scaled to a U.S. population mean of 50 and standard deviation of 10 (higher scores are better). Multiple groups have suggested minimum clinically important changes in SF-12 summary scores to be greater than 2-2.5 points, and moderate changes to be greater than 5 points.|12 Months (± 30 Days)|"Per ITT set.
Patients are included in the QoL endpoint if:
They completed the follow-up visit and the SF-12 Questionnaire at the visit"||units on a scale||Standard Deviation|Mean
796673|NCT00933270|Secondary|Major Adverse Events (MAVE)|"Defined as a composite rate of
stent thrombosis,
clinically apparent distal embolization (defined as causing end-organ damage, e.g. lower extremity ulceration, tissue necrosis, or gangrene),
procedure-related arterial rupture,
acute limb ischemia,
target limb amputation,
procedure related bleeding event requiring transfusion."|30 days (±7 days)|Per ITT set. Patients are included if: they had a procedure related MAVE event, return for their visit within the window, returned for a later visit and the sponsor has information about their clinical status within the endpoint time frame, last contact date predated the endpoint time frame but had an event within the endpoint time frame.||percentage of participants|||Number
796663|NCT00933270|Secondary|Quality of Life Assessed by SF-12 Questionnaire|The Medical Outcomes Study 12-Item Short form survey (SF-12) was used to assess generic QoL.SF-12 Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. Physical and mental summary scores from the SF-12 are scaled to a U.S. population mean of 50 and standard deviation of 10 (higher scores are better). Multiple groups have suggested minimum clinically important changes in SF-12 summary scores to be greater than 2-2.5 points, and moderate changes to be greater than 5 points.|6 Months (± 14 Days)|"Per ITT set.
Patients are included in the QoL endpoint if:
They completed the follow-up visit and the SF-12 Questionnaire at the visit."||units on a scale||Standard Deviation|Mean
796664|NCT00933270|Secondary|Quality of Life Assessed (QoL) by SF-12 Questionnaire|The Medical Outcomes Study 12-Item Short form survey (SF-12) was used to assess generic QoL. SF-12 Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. Physical and mental summary scores from the SF-12 are scaled to a U.S. population mean of 50 and standard deviation of 10 (higher scores are better). Multiple groups have suggested minimum clinically important changes in SF-12 summary scores to be greater than 2-2.5 points, and moderate changes to be greater than 5 points.|Baseline|"Per ITT set.
Patients are included in the QoL endpoint if:
They completed the SF-12 Questionnaire prior to the study procedure"||units on a scale||Standard Deviation|Mean
796665|NCT00933270|Secondary|Index Limb Amputations|Amputation was defined as the surgical removal of tissue anywhere from the toe to hip in the ipsilateral limb of the target site.|36 months (±30 days)|"Per ITT set.
Patients are included in the clinical endpoint if:
They return for their visit within the window
They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame
The last contact date predated the endpoint time frame but had an event within the endpoint time frame."||percentage of participants||95% Confidence Interval|Number
796666|NCT00933270|Secondary|Index Limb Amputations|Amputation was defined as the surgical removal of tissue anywhere from the toe to hip in the ipsilateral limb of the target site.|24 months (±30 days)|"Per ITT set.
Patients are included in the clinical endpoint if:
They return for their visit within the window
They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame
The last contact date predated the endpoint time frame but had an event within the endpoint time frame."||percentage of participants||95% Confidence Interval|Number
796667|NCT00933270|Secondary|Index Limb Amputations|Amputation was defined as the surgical removal of tissue anywhere from the toe to hip in the ipsilateral limb of the target site.|12 months (±30 days)|"Per ITT set.
Patients are included in the clinical endpoint if:
They return for their visit within the window
They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame
The last contact date predated the endpoint time frame but had an event within the endpoint time frame."||percentage of participants||95% Confidence Interval|Number
796668|NCT00933270|Secondary|Index Limb Amputations|Amputation was defined as the surgical removal of tissue anywhere from the toe to hip in the ipsilateral limb of the target site.|6 months (±14 days)|"Per ITT set.
Patients are included in the clinical endpoint if:
They return for their visit within the window
They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame
The last contact date predated the endpoint time frame but had an event within the endpoint time frame."||percentage of participants||95% Confidence Interval|Number
796669|NCT00933270|Secondary|Major Adverse Events (MAVE)|"Defined as a composite rate of
stent thrombosis,
clinically apparent distal embolization (defined as causing end-organ damage, e.g. lower extremity ulceration, tissue necrosis, or gangrene),
procedure-related arterial rupture,
acute limb ischemia,
target limb amputation,
procedure related bleeding event requiring transfusion."|36 months (±30 days)|Per ITT set. Patients are included if: they had a procedure related MAVE event, return for their visit within the window, returned for a later visit and the sponsor has information about their clinical status within the endpoint time frame, last contact date predated the endpoint time frame but had an event within the endpoint time frame.||percentage of participants|||Number
796670|NCT00933270|Secondary|Major Adverse Events (MAVE)|"Defined as a composite rate of
stent thrombosis,
clinically apparent distal embolization (defined as causing end-organ damage, e.g. lower extremity ulceration, tissue necrosis, or gangrene),
procedure-related arterial rupture,
acute limb ischemia,
target limb amputation,
procedure related bleeding event requiring transfusion."|24 months (±30 days)|Per ITT set. Patients are included if: they had a procedure related MAVE event, return for their visit within the window, returned for a later visit and the sponsor has information about their clinical status within the endpoint time frame, last contact date predated the endpoint time frame but had an event within the endpoint time frame.||percentage of participants|||Number
796671|NCT00933270|Secondary|Major Adverse Events (MAVE)|"Defined as a composite rate of
stent thrombosis,
clinically apparent distal embolization (defined as causing end-organ damage, e.g. lower extremity ulceration, tissue necrosis, or gangrene),
procedure-related arterial rupture,
acute limb ischemia,
target limb amputation,
procedure related bleeding event requiring transfusion."|12 months (±30 days)|Per ITT set. Patients are included if: they had a procedure related MAVE event, return for their visit within the window, returned for a later visit and the sponsor has information about their clinical status within the endpoint time frame, last contact date predated the endpoint time frame but had an event within the endpoint time frame.||percentage of participants|||Number
796672|NCT00933270|Secondary|Major Adverse Events (MAVE)|"Defined as a composite rate of
stent thrombosis,
clinically apparent distal embolization (defined as causing end-organ damage, e.g. lower extremity ulceration, tissue necrosis, or gangrene),
procedure-related arterial rupture,
acute limb ischemia,
target limb amputation,
procedure related bleeding event requiring transfusion."|6 Months (±14 days)|Per ITT set. Patients are included if: they had a procedure related MAVE event, return for their visit within the window, returned for a later visit and the sponsor has information about their clinical status within the endpoint time frame, last contact date predated the endpoint time frame but had an event within the endpoint time frame.||percentage of participants|||Number
797314|NCT00931528|Secondary|Patient and Partner Overall Sexual Satisfaction as Measured by the Sexual Adjustment Questionnaire (SAQ) at Weeks 28-30 and Years 1 and 2 After Initiation of RT||Baseline to 2 years from the start of radiation therapy||||||
796674|NCT00933270|Secondary|Limb Ischemia Improvement: Rutherford Becker Scale|"Defined as an improvement in the Rutherford-Becker Clinical Improvement Scale of greater than or equal to one.
Grade +3 = Markedly improved. Symptoms are gone or markedly improved. ABI increased to >0.90.
Grade +2 = Moderately improved. Still symptomatic but with improvement in lesion category. ABI increased by 0.10 but not normalized.
Grade +1 = Minimally improved. Categorical improvement in symptoms without significant ABI increase (0.10 or less) or vice versa (but not both).
Grade 0 = No change. No categorical shift and less than 0.10 change in ABI. Grade -1 = Mildly worse. Either worsening of symptoms or decrease in ABI of 0.10.
Grade -2 = Moderate worsening. Deterioration of the subject’s condition by one category or unexpected minor amputation.
Grade -3 = Marked worsening. Deterioration of the subject’s condition by more than one category or major amputation."|36 Months (±30 days)|"Per ITT set.
Patients are included in the Limb ischemia improvement if:
They had a baseline Rutherford Becker Clinical Classification done. They return for their visit and Rutherford Becker Clinical Classification was done."||percentage of limbs|||Number
796675|NCT00933270|Secondary|Limb Ischemia Improvement: Rutherford Becker Scale|"Defined as an improvement in the Rutherford-Becker Clinical Improvement Scale of greater than or equal to one.
Grade +3 = Markedly improved. Symptoms are gone or markedly improved. ABI increased to >0.90.
Grade +2 = Moderately improved. Still symptomatic but with improvement in lesion category. ABI increased by 0.10 but not normalized.
Grade +1 = Minimally improved. Categorical improvement in symptoms without significant ABI increase (0.10 or less) or vice versa (but not both).
Grade 0 = No change. No categorical shift and less than 0.10 change in ABI. Grade -1 = Mildly worse. Either worsening of symptoms or decrease in ABI of 0.10.
Grade -2 = Moderate worsening. Deterioration of the subject’s condition by one category or unexpected minor amputation.
Grade -3 = Marked worsening. Deterioration of the subject’s condition by more than one category or major amputation."|24 Months (±30 days)|"Per ITT set.
Patients are included in the Limb ischemia improvement if:
They had a baseline Rutherford Becker Clinical Classification done. They return for their visit and Rutherford Becker Clinical Classification was done."||percentage of limbs|||Number
796676|NCT00933270|Secondary|Limb Ischemia Improvement: Rutherford Becker Scale|"Defined as an improvement in the Rutherford-Becker Clinical Improvement Scale of greater than or equal to one.
Grade +3 = Markedly improved. Symptoms are gone or markedly improved. ABI increased to >0.90.
Grade +2 = Moderately improved. Still symptomatic but with improvement in lesion category. ABI increased by 0.10 but not normalized.
Grade +1 = Minimally improved. Categorical improvement in symptoms without significant ABI increase (0.10 or less) or vice versa (but not both).
Grade 0 = No change. No categorical shift and less than 0.10 change in ABI. Grade -1 = Mildly worse. Either worsening of symptoms or decrease in ABI of 0.10.
Grade -2 = Moderate worsening. Deterioration of the subject’s condition by one category or unexpected minor amputation.
Grade -3 = Marked worsening. Deterioration of the subject’s condition by more than one category or major amputation."|12 Months (±30 days)|"Per ITT set.
Patients are included in the Limb ischemia improvement if:
They had a baseline Rutherford Becker Clinical Classification done. They return for their visit and Rutherford Becker Clinical Classification was done."||percentage of limbs|||Number
796677|NCT00933270|Secondary|Limb Ischemia Improvement: Rutherford Becker Scale|"Defined as an improvement in the Rutherford-Becker Clinical Improvement Scale of greater than or equal to one.
Grade +3 = Markedly improved. Symptoms are gone or markedly improved. ABI increased to >0.90.
Grade +2 = Moderately improved. Still symptomatic but with improvement in lesion category. ABI increased by 0.10 but not normalized.
Grade +1 = Minimally improved. Categorical improvement in symptoms without significant ABI increase (0.10 or less) or vice versa (but not both).
Grade 0 = No change. No categorical shift and less than 0.10 change in ABI. Grade -1 = Mildly worse. Either worsening of symptoms or decrease in ABI of 0.10.
Grade -2 = Moderate worsening. Deterioration of the subject’s condition by one category or unexpected minor amputation.
Grade -3 = Marked worsening. Deterioration of the subject’s condition by more than one category or major amputation."|1 month (± 7 days)|"Per ITT set.
Patients are included in the Limb ischemia improvement if:
They had a baseline Rutherford Becker Clinical Classification done. They return for their visit and Rutherford Becker Clinical Classification was done."||percentage of limbs|||Number
796678|NCT00933270|Secondary|Target Vessel Revascularization|Defined as any repeat percutaneous intervention or bypass surgery performed in the target vessel at 36 months post-procedure.|36 months (±30 days)|"Per ITT set.
Patients are included in the clinical endpoint if:
They return for their visit within the window
They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame
The last contact date predated the endpoint time frame but had an event within the endpoint time frame."||percentage of participants||95% Confidence Interval|Number
796679|NCT00933270|Secondary|Target Vessel Revascularization|Defined as any repeat percutaneous intervention or bypass surgery performed in the target vessel at 24 months post-procedure.|24 months (±30 days)|"Per ITT set.
Patients are included in the clinical endpoint if:
They return for their visit within the window
They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame
The last contact date predated the endpoint time frame but had an event within the endpoint time frame."||percentage of participants||95% Confidence Interval|Number
796680|NCT00933270|Secondary|Target Vessel Revascularization|Defined as any repeat percutaneous intervention or bypass surgery performed in the target vessel at 12 months post-procedure.|12 months (±30 days)|"Per ITT set.
Patients are included in the clinical endpoint if:
They return for their visit within the window
They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame
The last contact date predated the endpoint time frame but had an event within the endpoint time frame."||percentage of participants||95% Confidence Interval|Number
796681|NCT00933270|Secondary|Target Vessel Revascularization|Defined as any repeat percutaneous intervention or bypass surgery performed in the target vessel at 6 months post-procedure.|6 months (± 14 days)|"Per ITT set.
Patients are included in the clinical endpoint if:
They return for their visit within the window
They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame
The last contact date predated the endpoint time frame but had an event within the endpoint time frame."||percentage of participants||95% Confidence Interval|Number
796693|NCT00933270|Secondary|Stent Fracture Rate|Stent fractures were analyzed by X-ray evaluation by a designated core laboratory and defined as type I, II, III, IV or V.|36 months (± 30 Days)|Per ITT set: Supera implanted. Patient returned for visit and had x-ray of stent. X-ray analyzed by core lab||percentage of participants|||Number
796682|NCT00933270|Secondary|SFA Patency: PSV Ratio > 2.4|Patency of the target lesion was defined as no evidence of restenosis or occlusion within the originally treated lesion based on a centrally-read Color Flow Doppler ultrasound in the absence of target lesion revascularization (TLR). Occlusion and restenosis were defined as no color flow or an increase in peak systolic velocity of > 2.0 when compared to the proximal normal segment.|12 Months (±30 days)|Per ITT set. Patients are included if they return for visit within the window, returned for a later visit & sponsor has information on their clinical status within the endpoint time frame, the last contact date predated the endpoint time frame but had an event within the endpoint time frame, had a duplex ultrasound performed & analyzed by core lab||percentage of participants||95% Confidence Interval|Number
796683|NCT00933270|Secondary|SFA Patency: PSV Ratio > 2.4|Patency of the target lesion was defined as no evidence of restenosis or occlusion within the originally treated lesion based on a centrally-read Color Flow Doppler ultrasound in the absence of target lesion revascularization (TLR). Occlusion and restenosis were defined as no color flow or an increase in peak systolic velocity of > 2.0 when compared to the proximal normal segment.|6 Months (± 14 days)|Per ITT set. Patients are included if: they return for visit within the window, returned for a later visit & sponsor has information on their clinical status within the endpoint time frame, the last contact date predated the endpoint time frame but had an event within the endpoint time frame, had a duplex ultrasound performed & analyzed by core lab||percentage of participants||95% Confidence Interval|Number
796684|NCT00933270|Secondary|SFA Patency: PSV Ratio ≥ 2.0|Patency of the target lesion was defined as no evidence of restenosis or occlusion within the originally treated lesion based on a centrally-read Color Flow Doppler ultrasound in the absence of target lesion revascularization (TLR). Occlusion and restenosis were defined as no color flow or an increase in peak systolic velocity of > 2.0 when compared to the proximal normal segment.|6 Months (± 14 days)|Per ITT set. Patients are included if: they return for visit within the window, returned for a later visit & sponsor has information on their clinical status within the endpoint time frame, the last contact date predated the endpoint time frame but had an event within the endpoint time frame, had a duplex ultrasound performed & analyzed by core lab||percentage of participants||95% Confidence Interval|Number
796685|NCT00933270|Secondary|Target Lesion Revascularization (TLR)|Defined as any repeat percutaneous intervention with or without evidence of stenosis ≥ 50%, to improve blood flow inside or within 5 mm proximally and/or distally of the treated target lesion.|36 months (± 30 Days)|"Per ITT set.
Patients are included in the clinical endpoint if:
They return for their visit within the window
They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame
The last contact date predated the endpoint time frame but had an event within the endpoint time frame."||percentage of participants||95% Confidence Interval|Number
796686|NCT00933270|Secondary|Target Lesion Revascularization (TLR)|Defined as any repeat percutaneous intervention with or without evidence of stenosis ≥ 50%, to improve blood flow inside or within 5 mm proximally and/or distally of the treated target lesion.|24 months (± 30 Days)|"Per ITT set.
Patients are included in the clinical endpoint if:
They return for their visit within the window
They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame
The last contact date predated the endpoint time frame but had an event within the endpoint time frame."||percentage of participants||95% Confidence Interval|Number
796687|NCT00933270|Secondary|Target Lesion Revascularization (TLR)|Defined as any repeat percutaneous intervention with or without evidence of stenosis ≥ 50%, to improve blood flow inside or within 5 mm proximally and/or distally of the treated target lesion.|12 months (± 30 Days)|"Per ITT set.
Patients are included in the clinical endpoint if:
They return for their visit within the window
They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame
The last contact date predated the endpoint time frame but had an event within the endpoint time frame."||percentage of participants||95% Confidence Interval|Number
796688|NCT00933270|Secondary|Target Lesion Revascularization (TLR)|Defined as any repeat percutaneous intervention with or without evidence of stenosis ≥ 50%, to improve blood flow inside or within 5 mm proximally and/or distally of the treated target lesion.|6 months (± 14 Days)|"Per ITT set.
Patients are included in the clinical endpoint if:
They return for their visit within the window
They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame
The last contact date predated the endpoint time frame but had an event within the endpoint time frame."||percentage of participants||95% Confidence Interval|Number
796689|NCT00933270|Secondary|Ankle-brachial Index (ABI) on Target Limb|A ratio of the highest ankle systolic blood pressure in one leg, usually measured with a 10 cm cuff at the ankle and using a continuous wave Doppler to detect return of blood flow in the anterior tibial and posterior tibial arteries, to the highest of either arm systolic blood pressure. Performed at rest with subject in supine position.|12 Months (± 30 Days)|Per ITT set: Patient returned for visit and had ABI measured||ratio||Standard Deviation|Mean
796690|NCT00933270|Secondary|Ankle-brachial Index (ABI) on Target Limb|A ratio of the highest ankle systolic blood pressure in one leg, usually measured with a 10 cm cuff at the ankle and using a continuous wave Doppler to detect return of blood flow in the anterior tibial and posterior tibial arteries, to the highest of either arm systolic blood pressure. Performed at rest with subject in supine position.|6 Months (± 14 Days)|Per ITT set: Patient returned for visit and had ABI measured||ratio||Standard Deviation|Mean
796691|NCT00933270|Secondary|Ankle-brachial Index (ABI) Measurements on Target Limb|A ratio of the highest ankle systolic blood pressure in one leg, usually measured with a 10 cm cuff at the ankle and using a continuous wave Doppler to detect return of blood flow in the anterior tibial and posterior tibial arteries, to the highest of either arm systolic blood pressure. Performed at rest with subject in supine position.|1 month (± 7 Days)|Per ITT set: Patient returned for visit and had ABI measured||ratio||Standard Deviation|Mean
796692|NCT00933270|Secondary|Ankle-brachial Index (ABI) Measurements on Target Limb|A ratio of the highest ankle systolic blood pressure in one leg, usually measured with a 10 cm cuff at the ankle and using a continuous wave Doppler to detect return of blood flow in the anterior tibial and posterior tibial arteries, to the highest of either arm systolic blood pressure. Performed at rest with subject in supine position.|Baseline|Per ITT set: Baseline ABI measured prior to study procedure||ratio||Standard Deviation|Mean
797315|NCT00931528|Secondary|Overall Sexual Function as Measured by the IIEF at Weeks 28-30 and Years 1 and 2 After Initiation of RT||Baseline to 2 years from the start of radiation therapy||||||
796695|NCT00933270|Secondary|Stent Fracture Rate|"Stent fractures were analyzed by X-ray evaluation by a designated core laboratory and defined as type I, II, III, IV or V.
Stent fracture classification
Type I - a single strut fracture only.
Type II - multiple single nitinol stent fractures that can occur at different sites.
Type III - multiple nitinol stent fractures resulting in complete transverse linear fracture but without stent displacement.
Type IV - a complete transverse linear type III fracture with stent displacement.
Type V - a spiral dissection of a stent."|12 months (± 30 Days)|Per ITT set: Supera implanted. Patient returned for visit and had x-ray of stent. X-ray analyzed by core lab||percentage of participants|||Number
796696|NCT00933270|Secondary|Long-Term Safety Endpoint (Clinically Driven TLR, Index Limb Amputation)||36 months (± 30 Days)|||percentage of participants||95% Confidence Interval|Number
796697|NCT00933270|Secondary|Long-Term Safety Endpoint (Clinically Driven TLR, Index Limb Amputation)||24 months (± 30 Days)|||percentage of participants||95% Confidence Interval|Number
796698|NCT00933270|Secondary|Long-Term Safety Endpoint (Clinically Driven TLR, Index Limb Amputation)||12 months (± 30 Days)|||percentage of participants||95% Confidence Interval|Number
796699|NCT00933270|Secondary|Secondary Safety Endpoint|Secondary safety endpoint was a combined rate of death at 30 (± 7) days, or TLR, index limb amputation, and an increase in Rutherford-Becker Classification by 2 classes at 36 months (± 30 Days)(comparing pre- to post-procedural assessments).|36 months (± 30 Days)|"Per ITT set.
Patients are included in the clinical endpoint if:
They return for their visit within the window
They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame
The last contact date predated the endpoint time frame but had an event within the endpoint time frame."||percentage of participants||95% Confidence Interval|Number
796700|NCT00933270|Secondary|Secondary Safety Endpoint|Secondary safety endpoint was a combined rate of death at 30 (± 7) days, or TLR, index limb amputation, and an increase in Rutherford-Becker Classification by 2 classes (comparing pre- to post-procedural assessments).|24 months (± 30 Days)|"Per ITT set.
Patients are included in the clinical endpoint if:
They return for their visit within the window
They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame
The last contact date predated the endpoint time frame but had an event within the endpoint time frame."||percentage of participants||95% Confidence Interval|Number
796701|NCT00933270|Secondary|Secondary Safety Composite Endpoint|Secondary safety endpoint was a combined rate of death at 30 (± 7) days, or TLR, index limb amputation, and an increase in Rutherford-Becker Classification by 2 classes at 12 months (± 30 Days) (comparing pre- to post-procedural assessments).|12 months (± 30 Days)|"Per ITT set.
Patients are included in the clinical endpoint if:
They return for their visit within the window
They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame
The last contact date predated the endpoint time frame but had an event within the endpoint time frame."||percentage of participants||95% Confidence Interval|Number
796702|NCT00933270|Secondary|Device Success|Device success, defined as achievement of a final residual diameter stenosis of <50% (by QA), using the assigned treatment only.|intraoperative|Per ITT set: Supera implanted. Post-procedure angiogram analyzed by core lab||percentage of participants||95% Confidence Interval|Number
796703|NCT00933270|Secondary|Procedural Success|Defined as device success with < 50% residual stenosis immediately after stent placement, mean trans-stenotic pressure gradient less than 5 mmHg, and without the occurrence of death, amputation or repeat revascularization of the target lesion during the hospital stay.|intraoperative|Per ITT set. Supera implanted. Post-procedure angiogram analyzed by core lab Occurrence of death, amputation or TLR during the hospital stay||percentage of participants||95% Confidence Interval|Number
796704|NCT00933270|Secondary|Technical (Lesion) Success|Technical (lesion) success, defined as the attainment of <50% residual stenosis by Quantitative Angiography (QA) by any percutaneous method as determined by the Angiographic core laboratory.|intraoperative|Per ITT set: Post-procedure angiogram analyzed by core lab||percentage of treated segments||95% Confidence Interval|Number
796705|NCT00933270|Primary|Primary Efficacy Endpoint: SFA Patency at 12 Months (± 30 Days), Defined as Freedom From Restenosis (PSVR ≥ 2.0) and TLR.|Patency of the target lesion was defined as no evidence of restenosis or occlusion within the originally treated lesion based on a centrally-read Color Flow Doppler ultrasound in the absence of target lesion revascularization (TLR). Occlusion and restenosis were defined as no color flow or an increase in peak systolic velocity of > 2.0 when compared to the proximal normal segment.|12 months|"Per ITT set.
Patients are included in the clinical endpoint if:
They return for their visit within the window
They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame
The last contact date predated the endpoint time frame but had an event within the endpoint time frame."||percentage of participants||95% Confidence Interval|Number
796706|NCT00933270|Primary|Primary Safety Endpoint: Freedom From Death, Target Lesion Revascularization (TLR), or Any Amputation of the Index Limb to 30 (±7) Days.||30 days|"Per ITT set.
Patients are included in the clinical endpoint if:
They return for their visit within the window
They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame
The last contact date predated the endpoint time frame but had an event within the endpoint time frame."||percentage of participants||95% Confidence Interval|Number
796707|NCT00933335|Secondary|Time to Death of Participants During Their Participation in the Study|Time to death is defined as the time from the treatment start date to the date of death.|Day of TST/I 131 TST dosimetric dose to date of database release (Week 1 to Week 520); First day of fludarabine cycle 1 to date of database release (Week -16 to Week 520)|ITT-Exposed Population||months||95% Confidence Interval|Median
796708|NCT00933335|Secondary|Number of Participants Who Died During Their Participation in the Study|Participants who died during the study period were evaluated for the overall survival endpoint.|Day of TST/I 131 TST dosimetric dose to date of database release (Week 1 to Week 520); First day of fludarabine cycle 1 to date of database release (Week -16 to Week 520)|ITT-Exposed Population||participants|||Number
796709|NCT00933335|Secondary|Time to Treatment Failure|Time to treatment failure is defined as the time from the treatment start date to the first occurrence of treatment withdrawal, a decision to seek additional therapy, study removal, progression, alternative therapy for lymphoma, or death.|First day of fludarabine cycle 1 to day prior to TST/I 131 TST dosimetric dose (Week -16 to Week 1); Day of TST/I 131 TST dosimetric dose to database release (Week 1 to Week 520)|ITT-Exposed Population. Participants with treatment failure were evaluated.||months||95% Confidence Interval|Median
796711|NCT00933335|Secondary|Time to Disease Progression or Death|Time to progression is the time from the treatment start date to the first documented disease progression or death. Disease progression: 50% increase from nadir of the sum of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be >2 cm in diameter per radiographic evaluation or >1 cm in diameter by physical examination.|First day of fludarabine cycle 1 to day prior to TST/I 131 TST dosimetric dose (Week -16 to Week 1); Day of TST/I 131 TST dosimetric dose to database release (Week 1 to Week 520)|ITT-Exposed Population. Participants with disease progression were evaluated.||months||95% Confidence Interval|Median
796712|NCT00933335|Secondary|Number of Participants With Progressive Disease (PD)|PD is defined as a 50% increase from nadir of the sum of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be >2 cm in diameter per radiographic evaluation or >1 cm in diameter by physical examination.|First day of fludarabine cycle 1 to day prior to TST/I 131 TST dosimetric dose (Week -16 to Week 1); Day of TST/I 131 TST dosimetric dose to database release (Week 1 to Week 520)|ITT-Exposed Population||participants|||Number
796713|NCT00933335|Secondary|Duration of Response for All Confirmed Responders|Duration of response was defined as the time from the first documented response to the first documented disease progression. Partial Response (PR): 50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions with no new lesions. Responders are the participants with CR, or CCR, or PR.|First day of fludarabine cycle 1 to day prior to TST/I 131 TST dosimetric dose (Week -16 to Week 1); Day of TST/I 131 TST dosimetric dose to database release (Week 1 to Week 520)|ITT-Exposed Population: all participants who received dosimetric and therapeutic doses and were classified as responders were evaluated.||months||95% Confidence Interval|Median
796714|NCT00933335|Secondary|Number of Participants With Progression of Disease|Progression of disease is defined as a 50% increase from nadir of the sum of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be >2 cm in diameter per radiographic evaluation or >1 cm in diameter by physical examination. All participants without progression of disease were censored.|First day of fludarabine cycle 1 to day prior to TST/I 131 TST dosimetric dose (Week -16 to Week 1); Day of TST/I 131 TST dosimetric dose to database release (Week 1 to Week 520)|ITT-Exposed Population: participants with confirmed response rates (CR, CCR, or PR) were evaluated.||participants|||Number
796715|NCT00933335|Secondary|Number of Participants With the Investigator-assessed Unconfirmed Responses of Complete Response (CR), Clinical Complete Response (CCR), and Partial Response (PR)|CR: Complete resolution of disease-related (DR) radiological abnormalities; disappearance of non-Hodgkin's lymphoma-related signs/symptoms. CCR: Complete resolution of DR symptoms except for residual scar tissue. PR: 50% reduction in the sum of the products of the longest perpendicular diameters of measurable lesions with no new lesions.|First day of fludarabine cycle 1 to day prior to TST/I 131 TST dosimetric dose (Week -16 to Week 1); Day of TST/I 131 TST dosimetric dose to database release (Week 1 to Week 520)|ITT-Exposed Population. Participants (par.) evaluable for response were those with >= 1 response assessment. 2 of 38 par. who received <3 cycles of fludarabine withdrew from the study and were not evaluable for response. 35 of 38 par. received TST and I 131 TST treatment and were evaluated for response.||participants|||Number
796716|NCT00933335|Secondary|Number of Participants With the Investigator-assessed Confirmed Responses of Complete Response (CR), Clinical Complete Response (CCR), and Partial Response (PR)|CR: Complete resolution of disease-related (DR) radiological abnormalities; disappearance of non-Hodgkin's lymphoma-related signs/symptoms. CCR: Complete resolution of DR symptoms except for residual scar tissue. PR: 50% reduction in the sum of the products of the longest perpendicular diameters of measurable lesions with no new lesions. A confirmed response (resp.) (CR/CCR/PR) had to be confirmed by a consecutive resp. (>=28 days later) that was the same/better. Individual confirmed resp. data only counts that resp. confirmed by the same resp.; not all possible combinations are represented.|First day of fludarabine cycle 1 to day prior to TST/I 131 TST dosimetric dose (Week -16 to Week 1); Day of TST/I 131 TST dosimetric dose to database release (Week 1 to Week 520)|ITT-Exposed Population. 2 participants (par.) who received <3 cycles of fludarabine (fl.) did not receive TST treatment and were not evaluated. Par. evaluable for response were those with >=1 assessment. Three par. were not evaluable for response. None of the responses could be confirmed after fl. treatment; thus, no data are reported for this arm.||participants|||Number
796717|NCT00933335|Primary|Number of Participants Receiving the Indicated Type of Supportive Care After Fludarabine Treatment and After TST Treatment|Supportive care involves interventions that help the participants to achieve comfort but do not affect the course of a disease. Supportive care involved administration of granulocyte colony-stimulating factor (G-CSF), granulocyte macrophage colony-stimulating factor (GM-CSF), red blood cell (RBC) transfusions, erythropoietin, and platelet transfusions.|First day of fludarabine cycle 1 to day prior to TST/I 131 TST dosimetric dose (Week -16 to Week 1); Day of TST/I 131 TST dosimetric dose to database release (Week 1 to Week 520)|ITT-Exposed Population: two participants who received less than 3 cycles of fludarabine did not receive TST treatment and were not evaluated.||participants|||Number
796718|NCT00933335|Primary|Number of Participants Who Received Any Supportive Care After Fludarabine Treatment and After TST Treatment|Supportive care involves interventions that help the participants to achieve comfort but do not affect the course of a disease.|First day of fludarabine cycle 1 to day prior to TST and iodine I 131 TST DD (Week -16 to Week 1); Day of TST and iodine I 131 TST DD to database release (Week 1 to Week 520)|ITT-Exposed Population: two participants who received less than 3 cycles of fludarabine did not receive TST treatment, and hence were not evaluated.||participants|||Number
796719|NCT00933335|Primary|Number of Participants With an Anti-infective Administered at Week 16 Post-Fludarabine (Fl) Treatment and Week 13 Post-TST Treatment|Anti-infectives are capable of acting against infection, by inhibiting the spread of an infectious agent or by killing the infectious agent outright. Anti-infective is a general term that encompasses antibacterials, antibiotics, antifungals, antiprotozoans, and antivirals.|Week 16 Post-Fludarabine Treatment (Week -16 to Week 0); Week 13 Post-TST Treatment (Week 1 to Week 13)|ITT-Exposed Population: all participants who received dosimetric and therapeutic doses and those who had an infection were evaluated.||participants|||Number
796794|NCT00934362|Secondary|Spirometry|Percent change (relative) in FEV1 between pre-treatment baseline and following 5 doses of study treatment. Post treatment values obtained 3 and approximately 22 hours after 5th dose were averaged to determine the treatment effect.|after 5 doses|per protocol||percent change||Standard Deviation|Mean
796720|NCT00933335|Primary|Number of Participants With Positive Culture Results for Infections at Week 16 Post-Fludarabine (Fl) Treatment and Week 13 Post-TST Treatment|The culture results could be positive or negative. The positive culture results indicates that the tested participant have the infection under investigation so therapeutic treatment with anti-infective is required.|Week 16 Post-Fludarabine Treatment (Week -16 to Week 0); Week 13 Post-TST Treatment (Week 1 to Week 13)|ITT-Exposed Population: all participants who received dosimetric and therapeutic doses, those who had an infection, and from whom the cultures were obtained were evaluated.||participants|||Number
796721|NCT00933335|Primary|Number of Participants With a Culture Obtained for Infection at Week 16 Post-Fludarabine (Fl) Treatment and Week 13 Post-TST Treatment|Specimen samples of the body fluid are cultured for testing whether the infectious organism is present and grown in the culture media to assess the growth pattern of the organisms present in the specimen.|Week 16 Post-Fludarabine Treatment (Week -16 to Week 0); Week 13 Post-TST Treatment (Week 1 to Week 13)|ITT-Exposed Population: all participants who received dosimetric and therapeutic doses and those who had an infection were evaluated.||participants|||Number
796722|NCT00933335|Primary|Number of the Indicated Type of Infection Reported by Investigator Based on Laboratory Testing at Week 16 Post-Fludarabine (Fl) Treatment and Week 13 Post-TST Treatment|An infection is the colonization of a host organism by a parasite species. Infecting parasites seek to use the host's resources to reproduce, often resulting in disease. Colloquially, infections are usually considered to be caused by microscopic organisms or microparasites like viruses, bacteria, and viroids, although larger organisms such as macroparasites and fungi can also infect.|Week 16 Post-Fludarabine Treatment (Week -16 to Week 0); Week 13 Post-TST Treatment (Week 1 to Week 13)|ITT-Exposed Population: all participants who received dosimetric and therapeutic doses and those who had an infection were evaluated. A single participant could have had more than one infection. The number analyzed in the category titles reflects the number of participants who had any infection.||number of infections|||Number
796723|NCT00933335|Primary|Number of Participants With Any Infection at Week 16 Post-Fludarabine Treatment and Week 13 Post-TST Treatment Detected by Laboratory Culture of Participant Sample or Investigator Report|An infection is the colonization of a host organism by a parasite species. Infecting parasites seek to use the host's resources to reproduce, often resulting in disease. Colloquially, infections are usually considered to be caused by microscopic organisms or microparasites like viruses, bacteria, and viroids, although larger organisms such as macroparasites and fungi can also infect.|Week 16 Post-Fludarabine Treatment (Week -16 to Week 0); Week 13 Post-TST Treatment (Week 1 to Week 13)|ITT-Exposed Population: all participants who received dosimetric and therapeutic doses were evaluated.||participants|||Number
796724|NCT00933335|Primary|Duration of Any Grade 3 or Grade 4 Toxicity for Hematological Parameters: Absolute Neutrophil Count (ANC), Hemoglobin, and Platelets|Adverse events were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades (G): 0=No AE or within normal limits; 1=Mild AE; 2=Moderate AE; 3=Severe and undesirable AE; 4=Life-threatening or disabling AE; 5=Death related to AE. ANC (10^3/mm^3): G1=1.5 to <2.0, G2=1.0 to <1.5, G3=0.5 to < 1.0, G4=<0.5. Hemoglobin (g/dL): G1=10.0 to <12.0, G2=8.0 to <10.0, G3=6.5 to <8.0, G4=< 6.5. Platelets (10^3/microliter): G1=75 to <150, G2=50 to <75, G3=25 to <50, G4=<25.|First day of fludarabine cycle 1 to day prior to TST and iodine I 131 TST dosimetric dose (DD) (Week -16 to Week 1); Day of TST and iodine I 131 TST DD to database release (Week 1 to Week 520)|ITT-Exposed Population: all participants who received dosimetric and therapeutic doses were evaluated.||days||Full Range|Median
796725|NCT00933335|Primary|Number of Participants With Any Grade 3 or Grade 4 Toxicity (AE) for Hematological Parameters (Absolute Neutrophil Count [ANC], Hemoglobin, and Platelets)|Adverse events were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades (G): 0=No AE or within normal limits; 1=Mild AE; 2=Moderate AE; 3=Severe and undesirable AE; 4=Life-threatening or disabling AE; 5=Death related to AE. ANC (10^3/mm^3): G1=1.5 to <2.0, G2=1.0 to <1.5, G3=0.5 to < 1.0, G4=<0.5. Hemoglobin (g/dL): G1=10.0 to <12.0, G2=8.0 to <10.0, G3=6.5 to <8.0, G4=< 6.5. Platelets (10^3/microliter): G1=75 to <150, G2=50 to <75, G3=25 to <50, G4=<25.|First day of fludarabine cycle 1 to day prior to TST and iodine I 131 TST dosimetric dose (DD) (Week -16 to Week 1); Day of TST and iodine I 131 TST DD to database release (Week 1 to Week 520)|ITT-Exposed Population: all participants who received dosimetric and therapeutic doses were evaluated.||participants|||Number
796726|NCT00933335|Primary|Nadir Values for Platelet Count|Nadir was defined as the lowest laboratory value recorded up to 120 days following the therapeutic dose (or dosimetric dose for participants who did not receive the therapeutic dose).|up to 120 days following the therapeutic dose (or dosimetric dose for participants who did not receive the therapeutic dose)|ITT-Exposed Population: only the 35 participants who received the dosimetric dose were evaluated.||10^3/microliter||Full Range|Median
796727|NCT00933335|Primary|Nadir Values for Hemoglobin|Nadir was defined as the lowest laboratory value recorded up to 120 days following the therapeutic dose (or dosimetric dose for participants who did not receive the therapeutic dose).|up to 120 days following the therapeutic dose (or dosimetric dose for participants who did not receive the therapeutic dose)|ITT-Exposed Population: only the 35 participants who received the dosimetric dose were evaluated.||g/dL||Full Range|Median
796728|NCT00933335|Primary|Nadir Values for Absolute Neutrophil Count (ANC)|Nadir was defined as the lowest laboratory value recorded up to 120 days following the therapeutic dose (or dosimetric dose for participants who did not receive the therapeutic dose).|up to 120 days following the therapeutic dose (or dosimetric dose for participants who did not receive the therapeutic dose)|ITT-Exposed Population: only the 35 participants who received the dosimetric dose were evaluated.||10^3/mm^3||Full Range|Median
796729|NCT00933335|Primary|Time to Nadir for Hematological Parameters: Absolute Neutrophil Count (ANC), Hemoglobin, and Platelets|Nadir was defined as the lowest laboratory value recorded up to 120 days following the therapeutic dose (or dosimetric dose for participants who did not receive the therapeutic dose).|up to 120 days following the therapeutic dose (or dosimetric dose for participants who did not receive the therapeutic dose)|ITT-Exposed Population: all participants who received the dosimetric dose were evaluated.||days||Full Range|Median
796730|NCT00933335|Primary|Number of Participants With Thyroid Medication Use Prior to the Therapeutic Dose|Thyroid medication included any prescribed medication for the treatment of thyroid dysfunction.|Baseline (study entry; Week -16) and Week 2 to Week 3 (prior to the therapeutic dose)|ITT-Exposed Population: all participants who received dosimetric and therapeutic doses were evaluated.||participants|||Number
796731|NCT00933335|Primary|Number of Participants With Elevated Thyroid-Stimulating Hormone (TSH) Levels at Baseline (Study Entry) and Weeks 25, 52, 78, 104, 130, 156, 182, 208, 234, 260, 286, 312, 364, 416, 468, and 512|The number of participants with elevated TSH levels is reported. An elevated TSH level indicates that an insufficient amount of the thyroid hormone is being produced. Insufficient thyroid hormone production is known as hypothyroidism. The normal range of TSH is between 0.2 and 6.1 milliunits per liter (mU/L).|Baseline (Week -16) and Weeks 25, 52, 78, 104, 130, 156, 182, 208, 234, 260, 286, 312, 364, 416, 468, and 512|ITT-Exposed Population: baseline TSH levels were determined for 36 participants. Of 35 participants who received the dosimetric and therapeutic doses of TST/I-131 TST, 2 had elevated TSH at baseline, and 33 were assessed for developing elevated TSH.||participants|||Number
796732|NCT00933335|Primary|Time to HAMA Positivity From the First TST/I 131 TST Dosimetric Dose for the Participants Achieving HAMA Positivity|Kaplan-Meier estimates of the time to HAMA positivity (days from the first fludarabine dose) was determined for participants who converted to HAMA positivity.|Day 1 to Day 730 (24 Months) after receiving the dosimetric dose|ITT-Exposed Population: participants who received dosimetric and therapeutic doses and those who were converted to HAMA positivity were evaluated.||days|||Number
796733|NCT00933335|Primary|Number of Participants Who Were Negative for Human Anti-murine Antibodies (HAMA) at Baseline (Study Entry) But Positive or Negative at Weeks 12 and 25 and at Months 12, 18, and 24|"The administration of murine antibodies may form HAMA. A HAMA assay was performed using the ImmunoSTRIP HAMA IgG enzyme-linked immune absorbent assay by a central laboratory (Covance Classic Laboratory Services, Indianapolis, IN). Fludarabine, a known immunosuppressant, might decrease HAMA production in addition to reducing bone marrow involvement. To be positive, a participant had to have a positive HAMA assessment at any follow-up visit (Weeks 12 and 25; Months 12, 18, and 24)."|Day 1 to Day 730 (24 Months) after receiving the dosimetric dose|ITT-Exposed Population: participants who were evaluable for HAMA (those who did not have a positive HAHA level at Baseline) and those who received dosimetric and therapeutic doses were evaluated.||participants|||Number
796734|NCT00933335|Primary|Number of Participants With the Indicated Treatment-related AEs Experienced by at Least 10% of Participants in the Combined Regimen|All noxious and unintended responses to a study treatment related to any dose were considered as TRAEs. A response to a study treatment indicates that a causal relationship between a study drug and an adverse event was at least a reasonable possibility, i.e., the relationship cannot be ruled out.|First day of fludarabine cycle 1 to day prior to TST and iodine I 131 TST DD (Week -16 to Week 1); Day of TST and iodine I 131 TST DD to database release (Week 1 to Week 520)|ITT-Exposed Population||participants|||Number
796735|NCT00933335|Primary|Number of Participants With the Indicated Grade 3 and Grade 4 AEs|AEs were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No AE or within normal limits; 1 = Mild AE; 2 = Moderate AE; 3 = Severe and undesirable AE; 4 = Life-threatening or disabling AE; 5 = Death related to AE. mm, millimeters; mm^3, millimeters cubed. Grade 3 and Grade 4 AEs are reported to focus on the most severe AEs.|First day of fludarabine cycle 1 to day prior to TST and iodine I 131 TST DD (Week -16 to Week 1); Day of TST and iodine I 131 TST DD to database release (Week 1 to Week 520)|ITT-Exposed Population||participants|||Number
796736|NCT00933335|Primary|Number of Participants With Any Treatment-related SAE|All of the treatment-related SAEs experienced by the participants were recorded.|First day of fludarabine cycle 1 to day prior to TST and iodine I 131 TST DD (Week -16 to Week 1); Day of TST and iodine I 131 TST DD to database release (Week 1 to Week 520)|ITT-Exposed Population||participants|||Number
796737|NCT00933335|Primary|Number of Participants With Any Serious Adverse Event (SAE)|An SAE was defined as any event occurring at any dose that results in any of the following outcomes: death, a life threatening adverse drug experience (at immediate risk of death from the experience as it occurred), inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered to be a serious adverse drug experience when based upon appropriate medical judgment.|First day of fludarabine cycle 1 to day prior to TST and iodine I 131 TST DD (Week -16 to Week 1); Day of TST and iodine I 131 TST DD to database release (Week 1 to Week 520)|ITT-Exposed Population||participants|||Number
796738|NCT00933335|Primary|Number of Participants With Any Treatment-related Grade 3 or Grade 4 Adverse Event|All of the treatment-related grade 3 (severe and undesirable) and grade 4 (life-threatening or disabling) adverse events experienced by the participants were recorded.|First day of fludarabine cycle 1 to day prior to TST and iodine I 131 TST DD (Week -16 to Week 1); Day of TST and iodine I 131 TST DD to database release (Week 1 to Week 520)|ITT-Exposed Population||participants|||Number
796739|NCT00933335|Primary|Number of Participants With Any Grade 3 or Grade 4 Adverse Event|Adverse events were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No adverse event or within normal limits; 1 = Mild adverse event; 2 = Moderate adverse event; 3 = Severe and undesirable adverse event; 4 = Life-threatening or disabling adverse event; 5 = Death related to adverse event.|First day of fludarabine cycle 1 to day prior to TST and iodine I 131 TST DD (Week -16 to Week 1); Day of TST and iodine I 131 TST DD to database release (Week 1 to Week 520)|ITT-Exposed Population||participants|||Number
796740|NCT00933335|Primary|Number of Participants With Any Treatment-related Adverse Event (TRAE)|All noxious and unintended responses to a study treatment related to any dose were considered as TRAEs. A response to a study treatment indicates that a causal relationship between a study drug and an adverse event was at least a reasonable possibility, i.e., the relationship cannot be ruled out.|First day of fludarabine cycle 1 to day prior to TST and iodine I 131 TST DD (Week -16 to Week 1); Day of TST and iodine I 131 TST DD to database release (Week 1 to Week 520)|ITT-Exposed Population||participants|||Number
796780|NCT00933933|Primary|Architect HIV Combo Test Data for Specificity and Sensitivity in Pregnant Female Population|HIV status was determined by the results of the HIV comparator assay, HIV-1 Western blot, HIV-2 Western blot, and HIV-1 ribonucleic acid (RNA) test.|3 months|HIV negative status determined for specimens reactive by investigational assay and/or comparator by supplemental testing algorithm including HIV-1 Western blot, HIV-2 enzyme immunoassay (EIA), HIV-2 Western blot, HIV-1 p24 Antigen assay and HIV-1 RNA. HIV positive status determined by HIV-1 Western blot. Specimens from pregnant females.||Blood specimens|||Number
796741|NCT00933335|Primary|Number of Participants With Any Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily have to have a causal relationship (association) with this treatment. Therefore, an AE was any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not it was considered to be related to the medicinal product. Laboratory abnormalities were recorded as AEs only if they were associated with clinical sequelae and/or required an intervention.|First day of fludarabine cycle 1 to day prior to TST and iodine I 131 TST dosimetric dose (DD) (Week -16 to Week 1); Day of TST and iodine I 131 TST DD to database release (Week 1 to Week 520)|Intent-to-Treat (ITT)-Exposed Population: all participants who were enrolled into the study and who received at least 1 dose of fludarabine. The data are presented for the subgroup of the ITT-Exposed Population for those participants who received the dosimetric and therapeutic dose of TST/I 131 TST.||participants|||Number
796742|NCT00933491|Primary|Radiographic Bone Level|Mean radiographic bone level at baseline|Baseline|||mm||Standard Deviation|Mean
796743|NCT00933491|Primary|Radiographic Bone Level|Mean radiographic bone level at 12 months|12 months|||mm||Standard Deviation|Mean
796744|NCT00933543|Secondary|Proportion of Patients With Dryness (Mild)||at 12 weeks after first treatment|Safety||participants|||Number
796745|NCT00933543|Secondary|Proportion of Patients With Hypopigmentation (Mild Moderate, Severe)||at 12 weeks after first treatment|Safety||participants|||Number
796746|NCT00933543|Secondary|Proportion of Patients With Severe and Very Severe Scarring at End of Study||week 12|||participants|||Number
796747|NCT00933543|Secondary|Proportion of Patients With Clear or Almost Clear Scarring at End of Study||week 12|||participants|||Number
796748|NCT00933543|Secondary|Proportion of Patients With Mild or Moderate Scarring at End of Study||week 12|||participants|||Number
796749|NCT00933543|Secondary|Proportion of Patients With Severe Hyperpigmentation||at 12 weeks after first treatment|Safety||participants|||Number
796750|NCT00933543|Secondary|Proportion of Patients With Mild and Moderate Hyperpigmentation||at 12 weeks after first treatment|Safety||participants|||Number
796751|NCT00933543|Secondary|Facial Pain Assessed Using a Visual Analogue Scale From 0 to 10, Where 0 Indicates no Pain and 10 Indicates Worst Pain Imaginable|Facial pain was assessed on a visual analogue scale ranging from 0-10cm.|directly after fourth treatment|Safety population||cm||Full Range|Mean
796752|NCT00933543|Secondary|Facial Pain Assessed Using a Visual Analogue Scale From 0 to 10, Where 0 Indicates no Pain and 10 Indicates Worst Pain Imaginable|Facial pain was assessed on a visual analogue scale ranging from 0-10cm.|directly after third treatment|Safety population||cm||Full Range|Mean
796753|NCT00933543|Secondary|Facial Pain Assessed Using a Visual Analogue Scale From 0 to 10, Where 0 Indicates no Pain and 10 Indicates Worst Pain Imaginable|Facial pain was assessed on a visual analogue scale ranging from 0-10cm.|directly after second treatment|Safety population||cm||Full Range|Mean
796754|NCT00933543|Secondary|Facial Pain Assessed Using a Visual Analogue Scale From 0 to 10, Where 0 Indicates no Pain and 10 Indicates Worst Pain Imaginable|Facial pain was assessed on a visual analogue scale ranging from 0-10cm.|directly after first treatment|Safety population||cm||Full Range|Mean
796755|NCT00933543|Secondary|Proportion of Patients With Success According to the Dichotomized IGA Scale Based on Facial Assessments 12 Weeks After the First Treatment. Success is Defined as an Improvement of at Least 2 Grades From the Baseline Score.||6 weeks after the first treatment|ITT||Participants|||Number
796756|NCT00933543|Secondary|Absolute Change From Baseline in Facial Total Lesion Count||6 weeks after the first treatment|ITT||lesions||Standard Deviation|Mean
796757|NCT00933543|Secondary|Absolute Change From Baseline in Facial Non- Inflammatory Lesion Count||6 weeks after the first treatment|ITT||lesions||Standard Deviation|Mean
796758|NCT00933543|Secondary|Absolute Change From Baseline in Facial Inflammatory Lesion Count||6 weeks after the first treatment|ITT||lesions||Standard Deviation|Mean
796759|NCT00933543|Secondary|Proportion of Patients With a Reduction of at Least 50% From Baseline in Facial Inflammatory Lesion Count From Baseline||12 weeks after first treatment|||participants|||Number
796760|NCT00933543|Secondary|Proportion of Patients With a Reduction of at Least 50% From Baseline in Facial Non-inflammatory Lesion Count||12 weeks after last treatment|ITT||participants|||Number
796761|NCT00933543|Secondary|Percent Change From Baseline in Facial Total Lesion Count||12 weeks after the first treatment|ITT||Percent change from baseline||Standard Deviation|Mean
796762|NCT00933543|Secondary|Percent Change From Baseline in Facial Total Lesion Count||6 weeks after the first treatment|ITT||Percent change from baseline||Standard Deviation|Mean
796763|NCT00933543|Secondary|Percent Change From Baseline in Facial Non Inflammatory Lesion Count||12 weeks after first treatment|ITT||percentage change from baseline||Standard Deviation|Mean
796764|NCT00933543|Secondary|Percent Change From Baseline in Facial Non Inflammatory Lesion Count||6 weeks after first treatment|ITT||percentage change from baseline||Standard Deviation|Mean
796765|NCT00933543|Secondary|Percent Change From Baseline in Facial Inflammatory (Nodules, Papules, and Pustules)Lesion Count||12 weeks after the first treatment|ITT||Percent change from baseline||Standard Deviation|Mean
796766|NCT00933543|Primary|Absolute Change From Baseline in Facial Non Inflammatory Lesion Count||12 weeks after first treatment|ITT||lesions||Standard Deviation|Mean
796767|NCT00933543|Primary|Absolute Change From Baseline in Facial Inflammatory Lesion Count (Nodules, Papules, and Pustules)||12 weeks after the first treatment|ITT||lesions||Standard Deviation|Mean
796768|NCT00933543|Secondary|Percent Change From Baseline in Facial Inflammatory (Nodules, Papules, and Pustules)Lesion Count||6 weeks after the first treatment|ITT||percent change from baseline||Standard Deviation|Mean
796769|NCT00933543|Primary|Proportion of Patients With Success According to the Dichotomized IGA Scale Based on Facial Assessments 12 Weeks After the First Treatment. Success is Defined as an Improvement of at Least 2 Grades From the Baseline Score.||12 weeks after the first treatment|ITT||percentage of participants||95% Confidence Interval|Number
796791|NCT00934180|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
796770|NCT00933608|Primary|N-acetylaspartate|The change in N-acetylaspartate (NAA) measured with magnetic resonance spectroscopy (MRS) is the primary outcome measure. NAA is a metabolite found predominately in neuronal cells, and its amount indicates tissue well being (the higher the better). In MRS studies NAA (and other metabolites like choline or myoinositol) are presented as a ratio to creatine (Cr) also measured by MRS. The concentration of creatine does not change is used as an internal standard. The ratio NAA/Cr is unitless. In summary, the measurable outcome will be the NAA/Cr ratio change from pre-to post treatment.|baseline (pre-treatment) and 4 months (post-treatment)|This is an intention to treat analysis, based on initial treatment assignment.||NAA/creatine Ratio||Standard Deviation|Mean
796771|NCT00933686|Secondary|Percentage of Participants With Positive Response on Quality of Life Assessment of Growth Hormone [GH] Deficiency in Adults (QoL AGHDA) Scale|Quality of Life Assessment of GH Deficiency in Adults (QoL AGHDA) questionnaire consists of 25 items that evoke yes or no answers. A score of 1 is given to each item affirmed and these are summed to give the total score. The maximum score is 25, which represents a poor quality of life. The minimum score is 0, which represents a good quality of life. Each question has to be answered with a NO/YES and for each YES, one point is added. The more YES, the higher the score and the worse. Decrease in the positive responses is an index of improvement. So, when the percentage of positive responses on the scale decreases, it is considered a response rate.|Baseline, Month 6 and 12|ITT population included all the participants who were randomized in the study. 'N' signifies number of participants who were evaluable for this outcome measure. 'n' signifies number of participants who were evaluable at each time-point for each arm group.||Percentage of participants|||Number
796772|NCT00933686|Secondary|Multidimensional Assessment of Fatigue (MAF) Total Score|Multidimensional Assessment of Fatigue (MAF) consists of 16 questions. The score range for first 14 questions is between 0 and 10 for each question while for the last two questions it is 0 and 4 for each question. Total score range for first 14 questions is 0 to 100 and for last two questions is 0 to 8. Lower scores on the each represent the better participant's condition, whereas, higher scores indicate worsening condition.|Baseline, Month 6 and 12|ITT population included all the participants who were randomized in the study. 'N' signifies number of participants who were evaluable for this outcome measure. 'n' signifies number of participants who were evaluable at each time-point for each arm group.||Units on a scale|||Number
796773|NCT00933686|Secondary|EuroQol 5-Dimensions (EQ-5D) Total Score|EuroQol 5-Dimensions (EQ-5D) questionnaire is a measure of health status and quality of life (QoL). The EQ-5D defines health in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Score range for each item is 0 to 3, with 3 being the most severe. Total score range is 0 to 15. Lower scores represent a better QoL.|Baseline, Month 1, 3, 6, 7, 9 and 12|ITT population included all the participants who were randomized in the study. 'N' signifies number of participants who were evaluable for this outcome measure. 'n' signifies number of participants who were evaluable at each time-point for each arm group.||Units on a scale||Standard Deviation|Mean
796774|NCT00933686|Secondary|Visual Analog Scale (VAS) Total Score|Visual Analog Scale (VAS) is a 100 millimeter (mm) scale. Intensity of pain range: 0 mm=no pain to 100 mm=worst possible pain.|Baseline, Month 1, 3, 6, 7, 9 and 12|ITT population included all the participants who were randomized in the study. 'N' signifies number of participants who were evaluable for this outcome measure. 'n' signifies number of participants who were evaluable at each time-point for each arm group.||mm||Standard Deviation|Mean
796775|NCT00933686|Secondary|Fibromyalgia Impact Questionnaire (FIQ) Total Score|Fibromyalgia Impact Questionnaire (FIQ) is a 10-item questionnaire that measures physical impairment, well-being, missed work, pain, fatigue, rest, stiffness, anxiety, and depression. Score ranges from 0 (best result - very well) to 100 (worst result - awful).|Baseline, Month 1, 3, 6, 7, 9 and 12|ITT population included all the participants who were randomized in the study. 'N' signifies number of participants who were evaluable for this outcome measure. 'n' signifies number of participants who were evaluable at each time-point for each arm group.||Units on a scale||Standard Deviation|Mean
796776|NCT00933686|Primary|Percentage of Participants With Less Than 11 Tender Points at Month 12|The musculoskeletal component in form of pain on palpation in at least 11 of 18 tender point sites is required to fulfill the ACR criteria for fibromyalgia syndrome, An important response is considered when the number of tender points falls below 11 since it is the threshold for fibromyalgia diagnosis.|Month 12|ITT population included all the participants who were randomized in the study. 'N' signifies number of participants who were evaluable for this outcome measure.||Percentage of participants|||Number
796777|NCT00933686|Primary|Percentage of Participants With Less Than 11 Tender Points at Month 6|The musculoskeletal component in form of pain on palpation in at least 11 of 18 tender point sites is required to fulfill the American College of Rheumatology (ACR) criteria for fibromyalgia syndrome, An important response is considered when the number of tender points falls below 11 since it is the threshold for fibromyalgia diagnosis.|Month 6|Intention-to-treat (ITT) population included all the participants who were randomized in the study. 'N' signifies number of participants who were evaluable for this outcome measure.||Percentage of participants|||Number
796778|NCT00933933|Secondary|Architect HIV Combo Test Data for Reactivity of Architect HIV Combo in Increased HIV Risk Populations|Reactivity was determined by the results of the Architect HIV Ag/Ab Combo assay and supplemental testing by HIV-1 Western blot, HIV-2 Western blot, and HIV-1 ribonucleic acid (RNA) test.|3 months|Final HIV status determined for specimens reactive by investigational assay and/or comparator by supplement testing algorithm. Supplemental testing involved HIV-1 Western blot, HIV-2 EIA, HIV-2 Western blot, HIV-1 p24 Antigen assay and HIV-1 RNA. HIV positive status determined by HIV-1 Western blot.||Blood specimens|||Number
796779|NCT00933933|Primary|Architect HIV Combo Test Data for Specificity and Sensitivity in Pediatric Population (From 2 up to 21 Years of Age)|HIV status was determined by the results of the HIV comparator assay, HIV-1 Western blot, HIV-2 Western blot, and HIV-1 ribonucleic acid (RNA) test.|3 months|Specificity determine from 588 specimens: 364 low risk, 95 increased risk, 47 increased risk (HIV-2 endemic area), 44 pregnant females low risk and 38 pregnant females increased risk with HIV negative status. Sensitivity determined from 65 specimens: 60 HIV-1 infected, 2 HIV-1 infected pregnant females, 2 HIV infected from HIV-2 endemic area.||Blood specimens|||Number
796792|NCT00934180|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
796781|NCT00933933|Primary|Architect HIV Combo Test Data for Clinical Sensitivity in HIV Positive Specimens|Positive HIV status was determined by the results of the HIV-1 Western blot, HIV-2 Western blot, and/or HIV-1 ribonucleic acid (RNA) test.|3 months|Sensitivity was determine using confirmed positive specimens/panels for HIV-1 Antigen (63 samples/panels/viral isolates), HIV-1 antibody (1003 US population) and HIV-2 antibody (201 endemic area of Ivory Coast) based on supplemental testing.||Blood specimens|||Number
796782|NCT00933933|Primary|Architect HIV Combo Test Data for Clinical Specificity in Population at Low Risk for HIV Infection|HIV status was determined by the results of the HIV comparator assay, HIV-1 Western blot, HIV-2 Western blot, and HIV-1 ribonucleic acid (RNA) test.|3 months|Specificity determined from 6,164 specimens from apparently healthy individuals (low risk): includes 250 specimens from pregnant females in first trimester and 580 specimens from low risk population prospectively collected and tested fresh during study. Total of 37 confirmed HIV positives by supplemental testing were excluded from analysis.||Blood Specimens|||Number
796783|NCT00934050|Primary|Treatment Emergent Adverse Events (TEAEs)|Safety and Tolerability was assessed by the incidence of Treatment Emergent Adverse Events (TEAEs)|12 months|As a result of safety findings, effective 15 December 2009, all 50 patients at the 2000 mg BID dose were withdrawn from the study. Subsequently patients who were on placebo or 250 mg BID in Study AD201 received 250 mg BID in Study AD251. Only Arms who completed the study per the protocol were included in the analysis.||participants|||Number
796784|NCT00934102|Primary|Front Surface Lens Deposits|Protein and lipid deposits on the contact lens surface as assessed by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the wearer's eye. Deposits were graded on a scale of 0 to 4 with 0 being none and 4 being severe.|Period 2, Day 6|Per Protocol. Only the data from participants who completed all study visits were analyzed.||Units on a Scale|Participants|Standard Deviation|Mean
796785|NCT00934128|Primary|Effects of BIPAP and VapoTherm Device on Severity of Dyspnea as Measured by the Numeric Rating Scale|Dyspnea, a subjective sensation experienced by participants, was assessed with the numeric rating scale (NRS) before and after each 2 hour intervention. The NRS is a validated 11-point scale ranging from 0 (no dyspnea) to 10 (worst dyspnea). Participants received either (1) 2 hours of HFO followed by a variable washout period and then 2 hours of BiPAP or (2) 2 hours of BiPAP followed by a variable wash-out period and then 2 hours of HFO.|Up to 5 hours, baseline/enrollment to 5 hours (2 hours for each treatment with variable wash-out period)|One participant assigned to receive BiPAP was mistakenly started on Vapotherm (High Flow Oxygen = HFO), and was reported here in the HFO group.||units on a scale||Inter-Quartile Range|Median
796786|NCT00934128|Primary|Number of Participants Completing Study Intervention|"Retention rate defined as the percentage of subjects able to complete the first phase (washout) of study.
A variable washout/follow-up period after the first intervention was used to determine the optimal duration required for participants to return to baseline dyspnea level. After participants completed the first intervention by one hour, they were able to proceed to the second intervention if (1) their dyspnea level was >/= baseline dyspnea level-1, or (2) their dyspnea level was >/= 3/10 after one hour."|Minimally 1 hour, up to 5 hours|||Participants|||Number
796787|NCT00934141|Secondary|Cost of Group|"The goal of the economic analysis was to estimate costs of each group for governmental authorities who might organize improvement collaboratives. We collected the cost of personnel (state employees, NIATx employees, coaches and consultants), data management, buildings and facilities, lodging, travel, telephone calls and miscellaneous costs. Costs were categorized as group specific (such as hotel costs for the learning sessions group) or non-group-specific, which included state-incurred costs for outreach, data management and infrastructure, encouraging participation and administration. Cost data were collected three times during the study period and aggregated to create a total cost estimate. Figures reported below represent costs at the arm/group level (costs were not assessed at the organizational level). Measure type is Number."|Baseline and 18 months|||USD ($)|||Number
796788|NCT00934141|Primary|Change in Average Continuation Rate Through the Fourth Treatment Session|"This outcome represents change in the rate at which a clinic's patients continue in treatment. Continuation rate is defined as the percentage of patients that make at least 4 visits to the clinic, on different days, before being discharged. Estimates of improvement show the average percentage points of improvement per month based on a best linear unbiased predictor estimate for each site.
Note: this study has three primary outcomes. The number of participants analyzed varies for each outcome. The (higher) number of clinics shown in the flow diagram results because clinics may have been analyzed on a subset of the three primary outcomes (e.g., analyzed for waiting time and continuation, but not for annual number of new patients). To be considered analyzed in the flow diagram, a clinic must have been included in at least one primary outcomes analysis."|Baseline and 21 months|||Change in continuation rate||Standard Error|Mean
796789|NCT00934141|Primary|Change in Annual Number of Patient Admissions|"We aimed to increase clinics' treatment capacity in this quality improvement study. Capacity was measured by counting clinics' annual number of patient admissions. We monitored changes in admission counts, per clinic, in a pre-post analysis. Changes in the natural logarithm of annual admissions are presented, which approximates the average percentage change (year-to-year) in the number of new patient admissions per clinic.
Note: this study has three primary outcomes. The number of participants analyzed varies for each outcome. The (higher) number of clinics shown in the flow diagram results because clinics may have been analyzed on a subset of the three primary outcomes (e.g., analyzed for waiting time and continuation, but not for annual number of new patients). To be considered analyzed in the flow diagram, a clinic must have been included in at least one primary outcomes analysis."|48 months (2 year baseline period and 2 year post-intervention period)|||Percent change (approx.)||95% Confidence Interval|Mean
796790|NCT00934141|Primary|Change in Average Waiting Time From First Contact to Treatment|"The average length of time in days it takes from when a patient first calls for help to the time a patient was able to meet a clinician. In this quality improvement study, changes in this measure over time are reported. Estimates of improvement show the average days of improvement per month based on a best linear unbiased predictor estimate for each site.
Note: this study has three primary outcomes. The number of participants analyzed varies for each outcome. The (higher) number of clinics shown in the flow diagram results because clinics may have been analyzed on a subset of the three primary outcomes (e.g., analyzed for waiting time and continuation, but not for annual number of new patients). To be considered analyzed in the flow diagram, a clinic must have been included in at least one primary outcomes analysis."|Baseline and 15 months|||Change in days||Standard Error|Mean
796795|NCT00934362|Primary|Change in Mucociliary Clearance|Clearance of radiolabeled particles, following inhalation, are followed over time. Average clearance rate through 60 minutes post inhaled isotope deposition is calculated. Absolute difference between baseline and post-treatment (e.g. <60 minutes after the last dose of lucinactant or placebo) reported.|1 hour after final treatment (5th dose) minus baseline|Per protocol||percent clearance||Standard Deviation|Mean
796796|NCT00934375|Primary|Number of Participants With Treatment-Emergent Adverse Events|Overview of Treatment-Emergent Adverse Events and Safety Population (TEAEs)|Baseline, Week 6, Week 12 and Week 28.|||Participants|||Number
796797|NCT00934440|Secondary|Time to Progression|The time to progression was measured using time from the first day of treatment to the first day of an evaluation of progressive disease or the date of death for any cause.|2 years|||months||Full Range|Mean
796798|NCT00934440|Primary|Toxicities by Dose Level|Toxicities determined using Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0|3 to 6 months|||adverse events|||Number
796799|NCT00934544|Secondary|Percentage of Participants With Bone Marrow Histomorphology at Week 48|This was noted as fibrosis density and was tabulated by fibrosis grade at baseline and at week 48 (post-baseline). Descriptive statistics (participant percentages) were used.|48 weeks|Full analysis set (FAS) consisted of all subjects who were randomized and put in strata according to International Working Group for Myelofibrosis Research and Treatment(IWG MRT) prognostic criteria.||Percentage of participants|||Number
796800|NCT00934544|Secondary|Overall Survival (OS) by Treatment|Defined as the interval between randomization and death from any cause. Hazard ratios of OS and the corresponding 95% CIs were estimated using the Cox proportional hazards model stratified by baseline prognostic category. For the comparison of OS between INC424 (INCB018424) and BAT, a stratified 2-sided log-rank test was used. Sensitivity analysis was also conducted for OS with the data being censored at the end of the Randomized Phase for those subjects who entered the Extension Phase. Unstratified analyses were also performed by reporting hazard ratios with 95% CIs.|every three months after EOS until end of extension phase (96 weeks LPLV for the primary end)||03/2016||||
796801|NCT00934544|Secondary|Leukemia-free Survival (LFS)|Defined as the interval between randomization and the date of the bone marrow blast count of 20% or greater OR the date of the first peripheral blast count of 20% or greater that was subsequently confirmed to have been sustained for at least 8 weeks OR the date of death from any cause, whichever occurs first.LFS was summarized using Kaplan-Meier estimates for each treatment arm. The estimates were supplemented by tables of number of events and probability estimates at several timepoints.|every three months after EOS until end of extension phase (96 weeks LPLV for the primary end)||03/2016||||
796802|NCT00934544|Secondary|Progression Free Survival (PFS) by Treatment|Defined as the time from the date of randomization/start of treatment to the date of the first documented disease progression including death due to any cause.|every three months after EOS until end of extension phase (96 weeks LPLV for the primary endpoint)||03/2016||||
796803|NCT00934544|Secondary|Time to First at Least 35% Reduction in Spleen Volume From Baseline by Treatment|﻿This is defined as the interval between randomization and date of the first MRI showing a 35% reduction from baseline in spleen volume. The analysis was performed for participants who achieved a 35% reduction in spleen volume.|Baseline, every 12 weeks until first 35% reduction in spleen is achieved|Full analysis set (FAS) consisted of all subjects who were randomized and put in strata according to International Working Group for Myelofibrosis Research and Treatment(IWG MRT) prognostic criteria. Treatment groups were defined according to the treatment assignment at the time of randomization.||Proportion of participants||95% Confidence Interval|Median
796804|NCT00934544|Secondary|Duration of Maintenance of at Least 35% Reduction in Spleen Volume (DoMSR) From Baseline|DoMSR is defined as the interval between the first spleen volume measurement that is >=35% reduction from baseline and the first scan that is no longer = 35% reduction AND that is a >25% increase over nadir. It was evaluated using the Kaplan-Meier estimate for each treatment arm. The analysis was performed only for subjects who achieved greater than 35% reduction in spleen volume.|Baseline, every 12 weeks until 25% progression from baseline|Full analysis set (FAS) consisted of all subjects who were randomized and put in strata according to International Working Group for Myelofibrosis Research and Treatment(IWG MRT) prognostic criteria. Treatment groups were defined according to the treatment assignment at the time of randomization.||Proportion of participants||95% Confidence Interval|Median
796805|NCT00934544|Secondary|Percentage of Participants With at Least 35% Reduction in Spleen Volume From Baseline at Week 24|The change in spleen volume from baseline to week 24 was measured by magnetic resonance imaging (MRI) (or by computer tomography (CT) for participants unable to undergo MRI) and was calculated only for participants who had an evaluable spleen volume at baseline. The percentage of participants achieving a greater than or equal to 35% reduction in spleen volume from baseline to week 24 was then calculated by treatment group.|Baseline, Week 24|Full analysis set (FAS) consisted of all subjects who were randomized and put in strata according to International Working Group for Myelofibrosis Research and Treatment(IWG MRT)prognostic criteria. The table included participants with non-missing baseline MRI measurement of spleen volume only.||Percentage of Participants|||Number
796806|NCT00934544|Primary|Percentage of Participants With at Least 35% Reduction in Spleen Volume From Baseline at Week 48|The change in spleen volume from baseline to week 48 was measured by magnetic resonance imaging (MRI) (or by computer tomography (CT) for participants unable to undergo MRI) and was calculated only for participants who had an evaluable spleen volume at baseline. The percentage of participants achieving a greater than or equal to 35% reduction in spleen volume from baseline to week 48 was then calculated by treatment group.|Baseline, Week 48|Full analysis set (FAS) consisted of all subjects who were randomized and put in strata according to International Working Group for Myelofibrosis Research and Treatment(IWG MRT) prognostic criteria. The table included participants with non-missing baseline MRI measurement of spleen volume only.||Percentage of Participants|||Number
796807|NCT00934596|Primary|Number of Participants With <=Grade I Gas Emboli as Assessed by Trans-esophageal Echocardiography TEE).|Grade 0, no residual gas emboli; grade I, gas emboli observed in 1 of the 3 anatomic areas - left atrium, left ventricle or aortic root during 1 cardiac cycle; grade II, gas emboli observed simultaneously in 2 of the 3 anatomic areas during 1 cardiac cycle; grade III, gas emboli observed simultaneously in all 3 anatomic areas during 1 cardiac cycle.|6-10 minutes after end of cardiopulmonary bypass|The number was determined before hand as per protocoll.||participants|||Number
797316|NCT00931528|Secondary|Spontaneous (Off-drug) EF at Years 1 and 2 After Initiation of RT||Baseline to 2 years from the start of radiation therapy||||||
796808|NCT00934596|Primary|Number of Participants With <=Grade I Gas Emboli as Assessed by Trans-esophageal Echocardiography TEE).|Grade 0, no residual gas emboli; grade I, gas emboli observed in 1 of the 3 anatomic areas - left atrium, left ventricle or aortic root during 1 cardiac cycle; grade II, gas emboli observed simultaneously in 2 of the 3 anatomic areas during 1 cardiac cycle; grade III, gas emboli observed simultaneously in all 3 anatomic areas during 1 cardiac cycle.|3-6 minutes after end of cardiopulmonary bypass|The number was determined before hand as per protocoll.||participants|||Number
796809|NCT00934596|Primary|Number of Participants With <=Grade I Gas Emboli as Assessed by Trans-esophageal Echocardiography TEE).|Grade 0, no residual gas emboli; grade I, gas emboli observed in 1 of the 3 anatomic areas - left atrium, left ventricle or aortic root during 1 cardiac cycle; grade II, gas emboli observed simultaneously in 2 of the 3 anatomic areas during 1 cardiac cycle; grade III, gas emboli observed simultaneously in all 3 anatomic areas during 1 cardiac cycle.|0-3 minutes after end of cardiopulmonary bypass|The number was determined before hand as per protocoll.||participants|||Number
796810|NCT00934596|Primary|Number of Air Microemboli Registered Over the Middle Cerebral Arteries by On-line Trans-cranial Echo-Doppler (TCD).|The number of air microemboli (also referred to as gaseous microembolic signals) was concomitantly counted in the right and left medial cerebral artery. The number of signals from the right and the left medial cerebral artery were summed, and presented as the total sum of the gaseous micromebolic signals from the right and left side. Counting of gaseous microembolic signals was done during three time intervals: Before cardiac ejection, after cardiac ejection and during 10 minutes after cardiopulmonary bypass.|During 10 minutes after cardiopulmonary bypass|||Air Microemboli||Standard Deviation|Mean
796811|NCT00934596|Secondary|pH at 45 Min of CPB|pH measured by arterial bloodgas at 45 minutes of CPB, comparison between groups|Intraoperative|||units on a scale||Inter-Quartile Range|Median
796812|NCT00934596|Post-Hoc|Fraction of Morphologically Damaged Red Blood Cells as Assessed by Scanning Electron Microscopy Studies.|Pieces of tubing from the cardiopulmonary circuit were prepared and photographed in a Scanning Electron Microscope. Visual inspection of each photograph by an investigator blinded to which group the photograph belonged to was performed. The proportion of damaged red blood cells over the total number of red blood cells were calculated.|Pieces of tubing collected after weaning from cardiopulmonary bypass|Samples were collected from 5 participants in each Group (total of 10 participants). For each participant 4 pieces of tubing were collected (20 pieces in each Group, total 40 pieces). Samples were photographed. One photograph from each individual was randomly selected and studied by an investigator blinded to Group (total of 10 photographs).||Fraction of Damaged Red Blood Cells||95% Confidence Interval|Mean
796813|NCT00934596|Secondary|Oxygenator Gas Flow at 45 Minutes of CPB|The amount of carbon dioxide gas flow through the oxygenator was measured and compared between groups.|Intraoperative|||L/minute||Inter-Quartile Range|Median
796814|NCT00934596|Secondary|De-airing Time After Cardiac Ejection|The duration in minutes of the period after cardiac ejection to finished de-airing procedure.|During de-airing procedure|||minutes||Inter-Quartile Range|Median
796815|NCT00934596|Primary|Number of Air Microemboli Registered Over the Middle Cerebral Arteries by On-line Trans-cranial Echo-Doppler (TCD).|The number of air microemboli (also referred to as gaseous microembolic signals) was concomitantly counted in the right and left medial cerebral artery. The number of signals from the right and the left medial cerebral artery were summed, and presented as the total sum of the gaseous micromebolic signals from the right and left side. Counting of gaseous microembolic signals was done during three time intervals: Before cardiac ejection, after cardiac ejection and during 10 minutes after cardiopulmonary bypass.|After cardiac ejection|||Air Microemboli||Standard Deviation|Mean
796816|NCT00934596|Secondary|De-airing Time Before Cardiac Ejection|Time in minutes starting at t1 (removal of aortic cross clamp) and ending at t2 (beginning of cardiac ejection).|Measured during intraoperative course|||minutes||Inter-Quartile Range|Median
796817|NCT00934596|Secondary|Total Time Required for De-airing|The total de-airing time as measured in minutes.|After removal of aortic cross-clamp to complete de-airing, an average of 11 minutes|||Minutes||Inter-Quartile Range|Median
796818|NCT00934596|Primary|Number of Air Microemboli Registered Over the Middle Cerebral Arteries by On-line Trans-cranial Echo-Doppler (TCD).|The number of air microemboli (also referred to as gaseous microembolic signals) was concomitantly counted in the right and left medial cerebral artery. The number of signals from the right and the left medial cerebral artery were summed, and presented as the total sum of the gaseous micromebolic signals from the right and left side. Counting of gaseous microembolic signals was done during three time intervals: Before cardiac ejection, after cardiac ejection and during 10 minutes after cardiopulmonary bypass.|Before cardiac ejection|||Air Microemboli||Standard Deviation|Mean
796819|NCT00934622|Secondary|Spectacle Independence|Spectacle independence is the percentage of patients that do not always need to wear glasses. This outcome measure is patient reported.|pre-op;1 week,1 month,3 months and 6 months after 2nd eye surgery|Patient population was not consistent throughout the study. Number of patients analyzed at each visit is as follows: Preoperative n=76, Week 1 n=61, 1 Month n=71, 3 Months n=70, 6 Months n=68.||Percentage of Participants|||Number
796820|NCT00934622|Primary|Visual Acuity|Comparison of visual acuity (measured in logMAR) prior to and following bilateral implantation of the AcrySof ReSTOR Aspheric Intraocular Lens (IOL). Visual parameters were assessed prior to and after the implantation of the second lens at 1 week, 1 month, 3 months, and 6 months. LogMAR, the unit of measure for visual acuity, is the “logarithm of the minimum angle of resolution”. A lower logMAR value indicates better visual acuity.|pre-operative;1 week,1 month, 3 months and 6 months after 2nd eye surgery|||logMAR||Standard Deviation|Mean
796821|NCT00934635|Secondary|Assessment of the Ratio of Dopamine D2-receptor Occupancies in Two Different Areas of the Brain|No measures available due to early termination of trial|Analysis of PET scans at Visit 3 (day 3)||||||
796822|NCT00934635|Secondary|Plasma Concentrations of Paliperidone and Risperidone|No measures available due to early termination of trial|Measurement of plasma concentration at Visit 3 (day 3)||||||
796823|NCT00934635|Primary|Percentage of Paliperidone or Risperidone Dopamine D2 Receptor Occupancies||Visit 3 (on day 3)|PET imaging data were not submitted for further analysis. D2-receptor occupancies could not be calculated due to the low number of subjects in the healthy control group.||percentage|||Number
797484|NCT00941655|Secondary|Median Blood Loss During Surgery|Blood loss during surgery is related to complexity of the operation and via that to the stage of disease (more tumor to be cytoreduced, more blood loss).|Day 1|||ml||Full Range|Median
796824|NCT00926783|Secondary|Incidence of Atrial Fibrillation (AF) Termination/Regularization|Incidence of Atrial Fibrillation (AF) termination/regularization is defined as AF terminates during a complex fractionated atrial electrograms (CFAE) procedure.|Duration of an Atrial Fibrillation RF ablation procedure (up to about 5 hours)|Per-protocol population with available outcome data||participants|||Number
796825|NCT00926783|Secondary|Change in Atrial Fibrillation Cycle Length From Baseline to the End of the Ablation Procedure for Each Target|Change in atrial fibrillation cycle length from baseline to the end of the ablation procedure for each target|Duration of an Atrial Fibrillation RF ablation procedure (up to 5 hours)|Per-protocol population with available outcome data||Milliseconds||Standard Deviation|Mean
796826|NCT00926783|Secondary|Fluoroscopy Time|"Fluoroscopy time is divided into: Fluoroscopy time for access - Time to track the NAVISTAR catheter to the chamber of interest; Fluoroscopy time to map - Creation of first workable map, ablation, and verification time; Fluoroscopy to create and verify all ablation points including pulmonary vein isolation and complex fractionated electrograms.
Fluoroscopy time for access is independent of the strategies and will not be included in comparative analysis."|Duration of an Atrial Fibrillation RF ablation procedure (up to about 5 hours)|Per-protocol population with available outcome data||Minutes||Standard Deviation|Mean
796827|NCT00926783|Secondary|Duration of Ablation Procedure|Duration of ablation procedure includes three components: Access time - Time from first stick to tracking of the NAVISTAR catheter to the chamber of interest; Mapping time - Creation of first workable map; Ablation and verification time - Creation and verification of all ablation points including pulmonary vein isolation and complex fractionated electrograms.|Duration of ablation procedure (up to about 5 hours)|Per-protocol population with available outcome data||Minutes||Standard Deviation|Mean
796828|NCT00926783|Primary|Total Radio-frequency (RF) Delivery Time During CFAE|Total RF delivery time (minutes) is defined as the duration of the RF delivered per ablation site and totaled for each procedure.|Duration of an Atrial Fibrillation RF ablation procedure (up to about 5 hours)|||Minutes||Standard Deviation|Mean
796829|NCT00926783|Primary|Proportion of Subjects Who Were Free From Atrial Arrhythmia at One Year.|Proportion of subjects who were free from atrial arrhythmia (no recurrence of atrial fibrillation, atrial flutter, and atrial tachycardia (AF/AFL/AT)) between Day 91 and Day 365 post first ablation procedure.|From day 91 to day 365 post first ablation procedure|Per-protocol population - subjects who underwent repeat ablation procedures within six months of initial procedures.||participants|||Number
796830|NCT00926796|Secondary|Number of Participants With Adverse Events for Each Regimen|Number of treated participants experiencing mild, moderate, severe, or life-threatening adverse events (AEs) either temporarily associated or not associated with study product.|Day 0 through Day 30|All participants receiving study medication comprised the safety population. Of 614 participants randomized, 603 received study medication.||participants|||Number
796831|NCT00926796|Primary|Microbiological Efficacy of Gemifloxacin and Azithromycin for the Treatment of Uncomplicated Gonococcal Infection|Percentage of enrollees negative by culture at cervix/urethra 10-17 days after treatment, regardless of history of re-exposure, among those with positive gonococcal cultures at enrollment (microbiological cure)|10-17 days after treatment.|Per protocol population (all randomized participants who took study drug, positive for gonorrhea, completed follow up visit, and met additional protocol specific conditions such as key inclusion/exclusion, the 10-17 day Visit 2 window requirement, etc.)||percentage of participants|||Number
796832|NCT00926796|Secondary|Antimicrobial Susceptibility Profile of Enrollment Isolates.|Minimum inhibitory concentration (micrograms/milliliter) of pretreatment gonorrhea isolates collected from participants|Isolates obtained at enrollment (Day 0).|Per protocol population (all randomized participants who too study drug, positive for gonorrhea, completed follow up visit, and met additional protocol specific conditions such as key inclusion/exclusion, the 10-17 day Visit 2 window requirement, etc.).||micrograms/milliliter||Full Range|Median
796833|NCT00926796|Secondary|Resolution of Symptoms and Signs (Clinical Cure)|Number of participants whose gonorrhea-related symptoms (e.g. vaginal/urethral discharge, dysuria, dyspareunia) present at enrollment has resolved by visit 2.|10-17 days after treatment.|Participants who had clinical symptoms at enrollment and were in the per protocol population (all randomized participants who took study drug, positive for gonorrhea, completed follow up visit, and met additional protocol specific conditions such as key inclusion/exclusion, the 10-17 day Visit 2 window requirement, etc.)||participants|||Number
796834|NCT00926796|Secondary|Clinical Profile of Treatment Failures.|For treatment failures (i.e., participants with positive culture at cervix/urethra 10-17 days after treatment), number participants with clinical symptoms (vaginal/urethral discharge, dysuria, dyspareunia) at 10-17 days.|10-17 days|Participants who had clinical symptoms at enrollment and were in the per protocol population (all randomized participants who took study drug, positive for gonorrhea, completed follow up visit, and met additional protocol specific conditions such as key inclusion/exclusion, the 10-17 day Visit 2 window requirement, etc.) with treatment failure.||participants|||Number
796835|NCT00926796|Secondary|Antimicrobial Susceptibility Profile of Treatment Failures.|For treatment failures (i.e., participants with positive culture at cervix/urethra 10-17 days after treatment), the minimum inhibitory concentrations for various antimicrobial agents (Azithromycin, Cefixime, Ceftriaxone, Ciprofloxacin, Gemifloxacin, Gentamicin, Penicillin, Tetracycline).|Isolates obtained at enrollment (Day 0).|Participants in the per protocol population (all randomized participants who took study drug, positive for gonorrhea, completed follow up visit, and met additional protocol specific conditions such as key inclusion/exclusion, the 10-17 day Visit 2 window requirement, etc.) with treatment failure.||micrograms/milliliter||Full Range|Median
796836|NCT00926796|Secondary|Eradication of Pharyngeal Infection|Number of enrollees with positive pharyngeal culture at enrollment who have negative culture 10-17 days after treatment|10-17 days after treatment.|Participants who were positive for pharyngeal gonorrhea at enrollment and were in the per protocol population (all randomized participants who took study drug, positive for gonorrhea, completed follow up visit, and met additional protocol specific conditions such as key inclusion/exclusion, the 10-17 day Visit 2 window requirement, etc.)||participants|||Number
796854|NCT00926952|Secondary|Number of Patients With Complete Clinical Response of All Actinic Keratoses at Week 12|The proportion of patients with a complete clinical response is calculated by dividing the number of patients with a complete response at week 12 by the number of participants at baseline.|12 weeks|The analysis was per protocol (PP). Imputation techniques were not required since all patients completed the study and no visits were missed.||Participants|||Number
796837|NCT00926796|Secondary|Eradication of Rectal Infection|Number of enrollees with positive rectal culture at enrollment who have negative culture 10-17 days after treatment|10-17 days after treatment.|Participants who were positive for rectal gonorrhea at enrollment and were in the per protocol population (all randomized participants who took study drug, positive for gonorrhea, completed follow up visit, and met additional protocol specific conditions such as key inclusion/exclusion, the 10-17 day Visit 2 window requirement, etc.)||participants|||Number
796838|NCT00926796|Primary|Microbiological Efficacy of Gentamicin and Azithromycin for the Treatment of Uncomplicated Gonococcal Infection|Percentage of enrollees negative by culture at cervix/urethra 10-17 days after treatment, regardless of history of re-exposure, among those with positive gonococcal cultures at enrollment (microbiological cure)|10-17 days after treatment.|Per protocol population (all randomized participants who took study drug, positive for gonorrhea, completed follow up visit, and met additional protocol specific conditions such as key inclusion/exclusion, the 10-17 day Visit 2 window requirement, etc.)||percentage of participants|||Number
796839|NCT00926887|Primary|Self-reported Pain Rating on the 0-100 VAS 24 Hours Post-operative.|Self-reported Degree of Pain rating using the standardized 0-100 VAS scale provided at 24 hours post-implant procedure, at which time the subject will not have taken any pain medication for at least four hours. VAS values range from '0' representing 'no pain at all' to '100' representing 'worst pain imaginable.'|24 hours|Intention to treat (ITT) analysis with imputation technique of Last Observation Carried Forward (LOCF).||scores on a scale||Standard Deviation|Mean
796840|NCT00926887|Secondary|Wound Healing Evaluation According to the Modified Hollander Cosmesis Scale||7 days post surgery||||||
796841|NCT00926887|Secondary|Infection Evaluation||24 hours & 7 days post surgery||||||
796842|NCT00926887|Secondary|Hydration Level Assessment||immediately, 24 hours & 7 days post surgery.||||||
796843|NCT00926887|Secondary|Use of Pain Management Medication Post-surgically.|Average number of rescue pain medication doses consumed across the 1st 7 post-operative days.|Through the 1st 7 post-operative days.|ITT with LOCF||medication doses||Standard Deviation|Mean
796844|NCT00926887|Secondary|Self-reported Degree of Pain Rating in the Breasts Area.||24 hours, 7 days, 14 days & 28 days post surgery||||||
796845|NCT00926887|Secondary|Swelling Evaluation Through Length by Width Breast Diameter Measurements||immediately, 24 hours & 7 days post surgery||||||
796846|NCT00926887|Primary|Number of Participants Who Scored Less Than 30 on the 0-100 Visual Analog Scale (VAS)for Pain 24 Hours Post-operative.|Self-reported Degree of Pain rating using the standardized 0-100 Visual Analog Scale (VAS) scale provided at 24 hours post-implant procedure, at which time the subject will not have taken any pain medication for at least four hours. The VAS ratings range from 0 to 100, where '0' represents 'no pain at all' and '100' represents 'worst pain imaginable.' A VAS of 30 is indicated as a cutoff threshold for 'success.' Participants who recorded a VAS rating of less than 30 were considered study 'successes' and are reported below.|24 hours post-operative|ITT Analysis with LOCF technique employed, as applicable.||participants|||Number
796847|NCT00926952|Secondary|Number of Adverse Events|To study the safety of MAL-PDT performed without occlusion when red light exposure takes place 90 minutes after the application of MAL by tracking adverse events until week 12 and adverse events until week 24|12, 24 weeks|The analysis was per protocol (PP). Imputation techniques were not required since all patients completed the study and no visits were missed.||Adverse events|||Number
796848|NCT00926952|Secondary|Mean Mottled Hyperpigmentation at Week 12|"This factor represents a visual assessment of light, patchy, mottled hyperpigmentation and solar freckling (including melasma) based on quantitative criteria such as the area/density of pigment, color intensity (dark vs. light), and uniformity of distribution (i.e. the more uneven or blotchy, the greater the score), Lentigines, nevi, and other pigmented lesions are not to be included in this assessment.
Rating Category 0 None 1-3 Mild 4-6 Moderate 7-9 Severe"|12 weeks|The analysis was per protocol (PP). Imputation techniques were not required since all patients completed the study and no visits were missed.||Units on a scale||Standard Deviation|Mean
796849|NCT00926952|Secondary|Mean Sallowness Score at Week 12|"This factor represents a visual assessment of color tone from very pink or rosy (0) to very sallow or pale (9).
Rating Category 0 None 1-3 Mild 4-6 Moderate 7-9 Severe"|12 weeks|The analysis was per protocol (PP). Imputation techniques were not required since all patients completed the study and no visits were missed.||Units on a scale||Standard Deviation|Mean
796850|NCT00926952|Secondary|Mean Coarse Wrinkling Score at Week 12|"This factor represents a visual assessment of the number and depth of coarse wrinkles (i.e. deep lines, furrows, or creases). Coarse wrinkles appear on the forehead, glabella, chin, and nasolabial and periorbital areas, and they tend to be located closer to the eyes and mouth than fine wrinkles.
Rating Category 0 None 1-3 Mild 4-6 Moderate 7-9 Severe"|12 weeks|The analysis was per protocol (PP). Imputation techniques were not required since all patients completed the study and no visits were missed.||Units on a scale||Standard Deviation|Mean
796851|NCT00926952|Secondary|Mean Fine Wrinkling Score at Week 12|"This factor represents a visual assessment of the number and depth of superficial wrinkles (i.e. shallow indentations or lines). Fine wrinkles typically appear in periorbital and perioral regions and are usually found further from the eyes and mouth than are coarse wrinkles.
Rating Category 0 None 1-3 Mild 4-6 Moderate 7-9 Severe"|12 weeks|The analysis was per protocol (PP). Imputation techniques were not required since all patients completed the study and no visits were missed.||Units on a scale||Standard Deviation|Mean
796852|NCT00926952|Secondary|Mean Griffiths Photonumeric Scale for Photodamage Score at Week 12|Griffiths photonumeric scale was evaluated by the dermatologist. Patients were placed under natural daylight or fluorescent lighting for grading. A direct comparison was then made between the subjects and photographic standards (provided in reference 1). If an exact match could not be made to a grade then an inter-grade number was used used, for example 1, 3, 5, or 7. Zero (0) is the least amount of photodamage, 8 is the most amount of photodamage.|12 weeks|The analysis was per protocol (PP). Imputation techniques were not required since all patients completed the study and no visits were missed.||Units on a scale||Standard Deviation|Mean
796853|NCT00926952|Secondary|Number of Actinic Keratosis Lesions With Complete Clinical Response at Day 0 and Week 12||0, 12 weeks|||Lesions|||Number
796855|NCT00926952|Primary|Mean Number of Facial Actinic Keratoses at Week 12||12 weeks|The analysis was per protocol (PP). Imputation techniques were not required since all patients completed the study and no visits were missed.||Lesions||Standard Deviation|Mean
796856|NCT00934648|Secondary|Percentage of Participants With Changes in Bone Density|Change in bone density in participants untreated with bisphosphonates was classified as percentage of participants with osteoporosis, osteopenia, or normal. In some participants, no determinations were available.|Screening, Weeks 48 and 104|ITT population||percentage of participants|||Number
796857|NCT00934648|Secondary|Percentage of Participants With a DAS28 Response by European League Against Rheumatism (EULAR) Category|DAS28-based EULAR response criteria were used to measure individual response as no response, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline greater than (>)1.2 with DAS28 less than or equal to (≤)3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to ≤5.1 or change from baseline >0.6 to ≤1.2 with DAS28 ≤5.1; non-responders: change from baseline ≤0.6 or change from baseline >0.6 and ≤1.2 with DAS28 >5.1.|Screening, Day 1, and Weeks 24 and 104|ITT population||percentage of participants|||Number
796858|NCT00934648|Secondary|Disease Activity Score Based on 28-Joint Count (DAS28)|DAS28 was calculated from the number of swollen joints and tender joints using the 28 joint count; the erythrocyte sedimentation rate (ESR) measured in millimeters per hour [mm/hr]); and the Patient's Global Assessment of disease activity (participant-rated visual analog assessment [VAS]) with transformed scores with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. Overall, a DAS28 score of less than or equal to (≤) 3.2 equals (=) low disease activity, and a DAS28 score of greater than (>) 3.2 to 5.1 = moderate to high disease activity.|Day 1 and Week 24|ITT population||scores on a scale||Standard Deviation|Mean
796859|NCT00934648|Primary|Percentage of Participants With an Adverse Event (AE)||Week 104|Safety population: included all participants who have received any part of an infusion of the study medication.||percentage of participants|||Number
796860|NCT00934791|Primary|Liver Volume at 2 Years After Kidney Transplantation|Liver volume at 2 years will be compared between the sirolimus and control (tacrolimus) groups using analysis of covariance (ANCOVA).|2 years|This study was terminated due to inadequate enrollment, no data was collected on the participant.|||||
796861|NCT00934843|Secondary|Total Intake/Output of Fluid|Total amount of all fluids in and out during the first 36 hours postoperatively in mL.|over 36 hours|||mL||Standard Deviation|Mean
796862|NCT00934843|Secondary|Urine Output|Total urine output in mL over the first 36 hours after cardiac surgery|over 36 hours|||mL||Standard Deviation|Mean
796863|NCT00934843|Secondary|Number of Participants Who Died Between 36 Hours and 30 Days Following Cardiac Surgery|Number of participants who died of any cause between 36 hours and 30 days following cardiac surgery|at 36 hours and 30 days|||participants|||Number
796864|NCT00934843|Secondary|Inotropic Score|The inotropic score was calculated by the equation using drug dosages in micrograms/kg/min, (dopamine+dobutamine) + (milrinonex10) + (epinephrinex100) and recorded hourly upon arrival to the ICUthrough 36 hours postoperatively. The highest score during this timeframe was recorded. This score converts dosages of commonly used inotropic medications into a score. The higher the score the more inotropic medications required. The minimum score would be zero indicating no inotropic medications were used. There is no maximum score.|over the first 36 hours after surgery|||Scores on a scale||Standard Deviation|Mean
796865|NCT00934843|Primary|Primary Endpoint: Number of Participants With Low Cardiac Output Syndrome (LCOS) or Death at 36 Hours From Admission to the Intensive Care Unit (ICU) After Surgery.|The presence of low cardiac output syndrome (LCOS) was defined by the same definition used in the PRIMACORP study (Hoffman TM.et.al. Circulation 2003 107:996-1002). Specifically, if there were clinical signs and symptoms of low cardiac output (e.g., tachycardia, oliguria, cold extremities, cardiac arrest, etc.) which required one or more of the following interventions: mechanical circulatory support, the escalation of existing pharmacological circulatory support to >100% over baseline, or the initiation of new pharmacological circulatory support.|36 hours|||participants|||Number
796866|NCT00934856|Secondary|Vss of Plasma Docetaxel|Docetaxel infusion duration = 1 hr (as per SmPC)|Cycle 1: pre-dose (Hr 0), 0.25, 0.5, 1, 2, 4, 8, 23 hrs post EOI of docetaxel on Day 1. Cycle 2: pre-dose (Hr 0), 0.5 hr and 59 min after start of infusion, 0.25, 0.5, 1, 2, 4, 8, 23 hrs post EOI of docetaxel on Day 1 (1 cycle = 21 days)|PK analysis population. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified cycle for each arm.||liters per square meter (L/m^2)||Standard Deviation|Mean
796867|NCT00934856|Secondary|CL of Plasma Docetaxel|Docetaxel infusion duration = 1 hr (as per SmPC)|Cycle 1: pre-dose (Hr 0), 0.25, 0.5, 1, 2, 4, 8, 23 hrs post EOI of docetaxel on Day 1. Cycle 2: pre-dose (Hr 0), 0.5 hr and 59 min after start of infusion, 0.25, 0.5, 1, 2, 4, 8, 23 hrs post EOI of docetaxel on Day 1 (1 cycle = 21 days)|PK analysis population. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified cycle for each arm.||liters/hour/square meter (L/hr/m^2)||Standard Deviation|Mean
796868|NCT00934856|Secondary|AUCinf of Plasma Docetaxel|Docetaxel infusion duration = 1 hr (as per SmPC)|Cycle 1: pre-dose (Hr 0), 0.25, 0.5, 1, 2, 4, 8, 23 hrs post EOI of docetaxel on Day 1. Cycle 2: pre-dose (Hr 0), 0.5 hr and 59 min after start of infusion, 0.25, 0.5, 1, 2, 4, 8, 23 hrs post EOI of docetaxel on Day 1 (1 cycle = 21 days)|PK analysis population. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified cycle for each arm.||hr*ng/mL||Standard Deviation|Mean
796869|NCT00934856|Secondary|t1/2 of Plasma Docetaxel|Docetaxel infusion duration = 1 hr (as per SmPC)|Cycle 1: pre-dose (Hr 0), 0.25, 0.5, 1, 2, 4, 8, 23 hrs post EOI of docetaxel on Day 1. Cycle 2: pre-dose (Hr 0), 0.5 hr and 59 min after start of infusion, 0.25, 0.5, 1, 2, 4, 8, 23 hrs post EOI of docetaxel on Day 1 (1 cycle = 21 days)|PK analysis population. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified cycle for each arm.||hours (hr)||Standard Deviation|Mean
796870|NCT00934856|Secondary|Cmax of Plasma Docetaxel|Docetaxel infusion duration = 1 hr (as per summary of product characteristics [SmPC])|Cycle 1: pre-dose (Hr 0), 0.25, 0.5, 1, 2, 4, 8, 23 hrs post EOI of docetaxel on Day 1. Cycle 2: pre-dose (Hr 0), 0.5 hr and 59 min after start of infusion, 0.25, 0.5, 1, 2, 4, 8, 23 hrs post EOI of docetaxel on Day 1 (1 cycle = 21 days)|PK analysis population. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified cycle for each arm.||ng/mL||Standard Deviation|Mean
798356|NCT00939211|Secondary|Systolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose|Average systolic blood pressure value|0, 30 min, 2 h, 4 h|||mmHg||Standard Deviation|Mean
796871|NCT00934856|Secondary|AUCinf of Plasma DM1||Cycle 1: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 2; on Days 3 and 8. Cycle 2: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 1; on Day 8 (1 cycle = 21 days) (T-DM1 infusion duration = 1.5 hrs)|PK analysis population. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified cycle for each arm.||day*ng/mL||Standard Deviation|Mean
796872|NCT00934856|Secondary|t1/2 of Plasma DM1||Cycle 1: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 2; on Days 3 and 8. Cycle 2: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 1; on Day 8 (1 cycle = 21 days) (T-DM1 infusion duration = 1.5 hrs)|PK analysis population. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified cycle for each arm.||days||Standard Deviation|Mean
796873|NCT00934856|Secondary|Cmax of Plasma N2’-Deacetyl-N2’-(3-mercapto-1-oxopropyl)-Maytansine (DM1)|DM1 is the metabolite of trastuzumab emtansine.|Cycle 1: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 2; on Days 3 and 8. Cycle 2: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 1; on Day 8 (1 cycle = 21 days) (T-DM1 infusion duration = 1.5 hrs)|PK analysis population. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified cycle for each arm.||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
796874|NCT00934856|Secondary|Vss of Total Serum Trastuzumab||Cycle 1: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 2; on Days 3 and 8. Cycle 2: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 1; on Day 8 (1 cycle = 21 days) (T-DM1 infusion duration = 1.5 hrs)|PK analysis population. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified cycle for each arm.||mL/kg||Standard Deviation|Mean
796875|NCT00934856|Secondary|CL of Total Serum Trastuzumab||Cycle 1: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 2; on Days 3 and 8. Cycle 2: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 1; on Day 8 (1 cycle = 21 days) (T-DM1 infusion duration = 1.5 hrs)|PK analysis population. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified cycle for each arm.||mL/day/kg||Standard Deviation|Mean
796876|NCT00934856|Secondary|AUCinf of Total Serum Trastuzumab||Cycle 1: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 2; on Days 3 and 8. Cycle 2: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 1; on Day 8 (1 cycle = 21 days) (T-DM1 infusion duration = 1.5 hrs)|PK analysis population. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified cycle for each arm.||day*mcg/mL||Standard Deviation|Mean
796877|NCT00934856|Secondary|t1/2 of Total Serum Trastuzumab||Cycle 1: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 2; on Days 3 and 8. Cycle 2: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 1; on Day 8 (1 cycle = 21 days) (T-DM1 infusion duration = 1.5 hrs)|PK analysis population. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified cycle for each arm.||days||Standard Deviation|Mean
796878|NCT00934856|Secondary|Cmax of Total Serum Trastuzumab||Cycle 1: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 2; on Days 3 and 8. Cycle 2: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 1; on Day 8 (1 cycle = 21 days) (T-DM1 infusion duration = 1.5 hrs)|PK analysis population. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified cycle for each arm.||mcg/mL||Standard Deviation|Mean
796879|NCT00934856|Secondary|Volume of Distribution at Steady State (Vss) of Serum Trastuzumab Emtansine||Cycle 1: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 2; on Days 3 and 8. Cycle 2: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 1; on Day 8 (1 cycle = 21 days) (T-DM1 infusion duration = 1.5 hrs)|PK analysis population. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified cycle for each arm.||mL/kg||Standard Deviation|Mean
796880|NCT00934856|Secondary|Clearance (CL) of Serum Trastuzumab Emtansine||Cycle 1: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 2; on Days 3 and 8. Cycle 2: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 1; on Day 8 (1 cycle = 21 days) (T-DM1 infusion duration = 1.5 hrs)|PK analysis population. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified cycle for each arm.||milliliters/day/kilogram (mL/day/kg)||Standard Deviation|Mean
796881|NCT00934856|Secondary|Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of Serum Trastuzumab Emtansine||Cycle 1: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 2; on Days 3 and 8. Cycle 2: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 1; on Day 8 (1 cycle = 21 days) (T-DM1 infusion duration = 1.5 hrs)|PK analysis population. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified cycle for each arm.||day*mcg/mL||Standard Deviation|Mean
796882|NCT00934856|Secondary|Apparent Terminal Half-Life (t1/2) of Serum Trastuzumab Emtansine||Cycle 1: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 2; on Days 3 and 8. Cycle 2: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 1; on Day 8 (1 cycle = 21 days) (T-DM1 infusion duration = 1.5 hrs)|PK analysis population. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified cycle for each arm.||days||Standard Deviation|Mean
796883|NCT00934856|Secondary|Maximum Observed Concentration (Cmax) of Serum Trastuzumab Emtansine||Cycle 1: pre-dose (Hour [Hr] 0), 0.25, 4 hrs post end of infusion (EOI) of T-DM1 on Day 2; on Days 3 and 8. Cycle 2: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 1; on Day 8 (1 cycle = 21 days) (T-DM1 infusion duration = 1.5 hrs)|Pharmacokinetic (PK) analysis population: PK-evaluable participants were defined as participants who received at least one dose of T-DM1 or docetaxel with at least one post-dose concentration data point. Number analyzed = participants evaluable for specified cycle for each arm.||micrograms per milliliter (mcg/mL)||Standard Deviation|Mean
796884|NCT00934856|Secondary|Number of Participants With Anti-Therapeutic Antibody (ATA) Response to Trastuzumab - MBC and LABC Population|Number of participants with ATA response was reported. Data for this outcome measure was planned to be reported for overall MBC and LABC participants and not by individual treatment arms.|Baseline (Day 1 of Cycle 1), Post baseline (at first follow-up visit [28 days after last dose of study drug][up to approximately 145 weeks])|All participants who received at least one dose of study medication were included. Here, number analyzed=participants evaluable for ATA at specified time-point.||participants|||Number
796885|NCT00934856|Secondary|Percentage of Participants With a BOR of CR or PR - LABC Population|BOR was defined as CR or PR recorded from baseline until disease progression/recurrence according to RECIST v1.0 criteria. For TLs, CR was defined as the disappearance of all TLs, and PR was defined as at least a 30% decrease in the sum of LDs of the TLs, taking as a reference the baseline (BL) sum of LDs. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. Percentage of participants with BOR rate was calculated as the (number of participants with CR or PR) divided by (total number of participants), and then multiplied by 100. The 95% Cl was determined using the Pearson-Clopper method.|Baseline until disease progression, recurrence or death (up to approximately 3 years)|LABC population||percentage of participants||95% Confidence Interval|Number
796886|NCT00934856|Secondary|Percentage of Participants With Pathological CR (pCR) - LABC Population|The pCR was defined as the absence of invasive neoplastic cells at microscopic examination of the tumor remnants and lymph nodes after surgery following primary systemic therapy.|Within 6 weeks of post-surgery (up to approximately 3 years)|LABC population: All participants with LABC who received at least one dose of study medication.||percentage of participants||95% Confidence Interval|Number
796887|NCT00934856|Secondary|Duration of Response - MBC Population|Duration of response was calculated for participants with CR or PR based on the RECIST v1.0 criteria. Duration of response was defined as the time interval between the date the CR or PR was first recorded and the date on which PD was first noted or date of death, whichever occurred first. Participants with no documented PD after CR or PR were censored at the last date at which they were known to have had the CR or PR, respectively. Median duration of response was estimated using the Kaplan-Meier method.|Baseline until disease progression, recurrence or death (up to approximately 3 years)|MBC population||months||Full Range|Median
796888|NCT00934856|Secondary|Percentage of Participants With CR or PR or Stable Disease (SD) for at Least 6 Months [Clinical Benefit Rate (CBR)] - MBC Population|CBR was defined as percentage of participants experiencing SD of at least 6 months from the start of treatment plus CR or PR according to the RECIST v1.0 criteria. For TLs: CR- disappearance of all TLs. PR- at least 30% decrease in the sum of LDs of the TLs, taking as a reference the BL sum of LDs. PD- at least 20% increase in the sum of LD of TLs, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more lesions. SD- neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. For NTLs: CR- disappearance of all NTLs and normalization of tumor marker levels. SD- persistence of one or more NTLs and/or maintenance of tumor marker level above the normal limits. Percentage of participants= number of participants with CR/PR/SD divided by total number of participants, and then multiplied by 100. 95% CI was determined using the Pearson-Clopper method.|Baseline until disease progression, recurrence or death (up to approximately 3 years)|MBC population||percentage of participants||95% Confidence Interval|Number
796889|NCT00934856|Secondary|Time to Treatment Failure (TTF) - MBC Population|TTF was defined as the time interval between the date of start of treatment and the date of PD, death from any cause, withdrawal from study treatment, or initiation of non-protocol anti-cancer therapy, whichever occurred first. Participants without an event at the time of the analysis were censored at the date of the last follow-up assessment. Median TTF was estimated using the Kaplan-Meier method.|Baseline until end of treatment (up to 39.8 months)|MBC population||months||Full Range|Median
796890|NCT00934856|Secondary|Percentage of Participants With Treatment Failure - MBC Population|Treatment failure was defined as the discontinuation of treatment for any reason, including the following qualifying events: PD, death from any cause, withdrawal from study treatment, or initiation of nonprotocol anti-cancer therapy. Percentage of participants with treatment failure was calculated as the (number of participants with treatment failure) divided by (total number of participants), and then multiplied by 100.|Baseline until end of treatment (up to 39.8 months)|MBC population||percentage of participants|||Number
796891|NCT00934856|Secondary|Percentage of Participants With a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) - MBC Population|BOR was defined as CR or PR recorded from baseline until disease progression/recurrence according to RECIST v1.0 criteria. For TLs, CR was defined as the disappearance of all TLs, and PR was defined as at least a 30% decrease in the sum of LDs of the TLs, taking as a reference the baseline (BL) sum of LDs. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. Percentage of participants with BOR rate was calculated as the (number of participants with CR or PR) divided by (total number of participants), and then multiplied by 100. The 95% confidence interval (Cl) was determined using the Pearson-Clopper method.|Baseline until disease progression or recurrence (up to approximately 3 years)|MBC population||percentage of participants||95% Confidence Interval|Number
796892|NCT00934856|Secondary|PFS - MBC Population|PFS was defined as the time interval between the date of the start of treatment and the date of first documentation of PD or death from any cause, whichever occurred first. Response was based on RECIST v1.0. For TLs, PD was at least a 20 % increase in the sum of LD of TLs, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more lesions. For NTLs, PD was the appearance of one or more new lesions and/or unequivocal progression of existing NTLs. Median PFS time was calculated using Kaplan-Meier estimates. Data for participants without PD or death was censored at the time of the last response assessment.|Baseline until disease progression or death (up to approximately 3 years)|MBC population||months||Full Range|Median
796893|NCT00934856|Secondary|Percentage of Participants With Progression-Free Survival (PFS) Event - MBC Population|PFS was defined as the time interval between the date of the start of treatment and the date of first documentation of progressive disease (PD) or death from any cause, whichever occurred first. Response was based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 (v1.0). For target lesions (TLs), PD was at least a 20 percent (%) increase in the sum of longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more lesions. For non-target lesions (NTLs), PD was the appearance of one or more new lesions and/or unequivocal progression of existing NTLs. Data for participants without PD or death was censored at the time of the last response assessment. Percentage of participants with PFS event was calculated as the (number of participants with PFS event [PD or death]) divided by (total number of participants), and then multiplied by 100.|Baseline until disease progression or death (up to approximately 3 years)|MBC population: All participants with MBC who received at least one dose of study medication were included.||percentage of participants|||Number
798357|NCT00939211|Secondary|Forced Expiratory Volume in One Second (FEV1), Effect at 15 Minutes Post-dose|15 min FEV1 value|15 min|||L||Standard Deviation|Mean
796894|NCT00934856|Primary|Percentage of Participants With Adverse Events (AEs) or Serious AEs (SAEs) - MBC and LABC Population|An AE is any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires in-patient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|Baseline up to 28 days after last dose for MBC participants and for LABC participants who could not undergo surgery, and up to 6 weeks post-surgery for LABC participants who underwent surgery (maximum up to approximately 3 years)|All participants who received at least one dose of study medication were included.||percentage of participants|||Number
796895|NCT00934856|Primary|Number of Participants With Dose Limiting Toxicity (DLT) - MBC and LABC Feasibility Population|DLTs included (as per National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] grading): Grade 4 thrombocytopenia, thrombocytopenia of any grade with concurrent hemorrhage or requiring blood platelet transfusion, or thrombocytopenia not recovered by Day 21 to at least 100,000/microliter (mcL); Grade 4 neutropenia lasting for more than 7 days; Febrile neutropenia; Grade greater than or equal to (>/=) 3 neurotoxicity in the form of peripheral neuropathy or peripheral neurotoxicity not improving to baseline or Grade less than or equal to (</=) 1 by Day 21; Any non-hematological toxicity of Grade >/= 3 except for alopecia, fever, and chills, not improving to baseline or Grade </=1 by Day 21, despite adequate toxicity management; Any subjective intolerable toxicity felt by the investigator to be related to either study treatment; Any other treatment-related toxicity prohibiting the start of the Cycle 2 on Day 22; Fulminant skin rash.|Cycle 1 (up to 21 days)|MBC and LABC feasibility population: All participants who received at least one dose of study medication and included in the feasibility part of the study.||participants|||Number
796896|NCT00934921|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
796897|NCT00934921|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
796898|NCT00934921|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
796899|NCT00934947|Secondary|Anxiety Symptoms||Study days 5, 7, 10, 13, 17, and 19, study week 6, study months 3 and 6||||||
796900|NCT00934947|Secondary|Itch Symptoms||Study days 5, 7, 10, 13, 17, and 19, study week 6, study months 3 and 6||||||
796901|NCT00934947|Secondary|Sleep Quality||Study days 5, 7, 10, 13, 17, and 19, study week 6, study months 3 and 6||||||
796902|NCT00934947|Primary|Overall Pain Trajectory Slopes|Overall pain trajectory slopes by treatment group, where linear mixed modeling was used to combine pain measurements (waking, worst, and least pain) assessed on primary outcome days into an overall pain score. Pain was assessed using a 0-10 numeric rating scale (NRS). A lower score on the NRS indicated less pain and a higher score was indicative of worse pain.|Study days 5, 7, 10, 13, 17 and 19|||Numeric Rating Scale Score Change/Day||95% Confidence Interval|Least Squares Mean
796903|NCT00935493|Secondary|Quality of Life (SF-36 MCS)|"Quality of Life (QOL) was assessed using the SF-36 (36-Item Short-Form Health Survey; QualityMetric, Lincoln, RI), MCS subscale. The SF-36 is a self-administered general health-related quality of life scale with 36 items. The MCS subscale has been shown to be responsive in psychoactive drug trials. The score range is 0-100.
Higher scores represent better mental health; therefore, the least squares means listed here represent mean outcome changes from baseline."|12 weeks|119 of the 123 trial participants had outcome data recorded at 12 weeks of follow up||units on a scale||Standard Error|Least Squares Mean
796904|NCT00935493|Secondary|Alzheimer’s Disease Cooperative Study—Clinical Global Impression of Change (ADCS-CGIC)|The seven-point scale was collapsed into 3 groups and coded as a three-level ordinal scale of global status, representing ordered levels of worse (including minimally, moderately and markedly worse), unchanged, and improved (including minimally, moderately, and markedly improved) global status.|12 weeks|119 of the 123 trial participants had outcome data recorded at 12 weeks of follow-up||participants|||Number
796905|NCT00935493|Primary|Mean in the Prefrontal Executive Function Z-score (PEF6_6)|"The primary outcome measure (PEF6_Z) is the mean of z-scores for 6 executive function tasks (CANTAB: Spatial Working Memory, Stockings of Cambridge, Intradimensiona/Extradimensional Shift, Paired Associates Learning; Stroop Color Word Score, Trail Making Test – B).
The score is composed of six component scales coded as z scores that measures cognitive functioning in which higher scores represent better cognitive functioning; therefore, the least squares means listed here represent mean outcome changes from baseline"|12 weeks|119 of the 123 trial participants had outcome data recorded at 12 weeks follow-up.||Z-score||Standard Error|Least Squares Mean
796906|NCT00935532|Secondary|Assessment on Event Rate of Treatment-emergent Minor Hypoglycemic Events|Minor confirmed hypoglycemia was defined as any event a patient felt that he or she was experiencing a sign or symptom associated with hypoglycemia that resolved by self-treatment or on its own, and a concurrent self-monitoring fingerstick blood glucose <3.0 mmol/L (54 mg/dL) and not classified as major hypoglycemia. Event rate per subject year was calculated for each subject: (number of events observed from a subject/exposure from a subject)*365.25 where exposure = last postbaseline visit date - baseline visit date. Mean and SE were then derived from FAS.|Baseline to Week 26|FAS Population.||events per subject-year||Standard Error|Mean
796907|NCT00935532|Secondary|Assessment on Event Rate of Treatment-emergent Major Hypoglycemic Events|Major confirmed hypoglycemia was defined as (1) any event accompanying symptoms consistent with hypoglycemia that resulted in loss of consciousness or seizure but resolved promptly in response to administration of glucagon or (2) glucose, or documented hypoglycemia (blood glucose <3.0 mmol/L [54 mg/dL]) requiring assistance because of severe impairment in consciousness or motor activity whether or not symptoms of hypoglycemia were felt by the patient. Event rate per subject year was calculated for each subject: (number of events observed from a subject/exposure from a subject)*365.25 where exposure = last postbaseline visit date - baseline visit date. Mean and SE were then derived from FAS.|Baseline to Week 26|FAS Population.||events per subject-year||Standard Error|Mean
796909|NCT00935532|Secondary|Ratio of Fasting Triglycerides at Endpoint (Week 26) to Baseline|Ratio of Triglycerides (measured in mg/dL) at endpoint (Week 26) to Baseline. Log(Postbaseline Triglycerides) - log(Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline.|Baseline, Week 26|FAS Population. Missing data at endpoint was imputed using LOCF approach.||ratio||Standard Error|Least Squares Mean
796910|NCT00935532|Secondary|Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Endpoint (Week 26)|Change in HDL-C from baseline to endpoint (Week 26)|Baseline, Week 26|FAS Population. Missing data at endpoint was imputed using LOCF approach.||mg/dL||Standard Error|Least Squares Mean
796911|NCT00935532|Secondary|Change in Total Cholesterol From Baseline to Endpoint (Week 26)|Change in Total Cholesterol from baseline to endpoint (Week 26)|Baseline, Week 26|FAS Population. Missing data at endpoint was imputed using LOCF approach.||mg/dL||Standard Error|Least Squares Mean
796912|NCT00935532|Secondary|Change in Body Weight From Baseline to Endpoint (Week 26)|Change in Body Weight from baseline to endpoint (Week 26)|Baseline, Week 26|FAS Population. Missing data at endpoint was imputed using LOCF approach.||kg||Standard Error|Least Squares Mean
796913|NCT00935532|Secondary|Change in Fasting Serum Glucose (FSG) From Baseline to Endpoint (Week 26)|Change in FSG (centralized measurement) from baseline to endpoint (Week 26)|Baseline, Week 26|FAS Population. Missing data at endpoint was imputed using LOCF approach.||mg/dL||Standard Error|Least Squares Mean
796914|NCT00935532|Secondary|Percentage of Subjects Achieving HbA1c<=6.5%|Percentage of subjects achieving HbA1c <=6.5% (for subjects with HbA1c >6.5% at baseline)|Baseline, Week 26|FAS Population. Only subjects with baseline HbA1c > target were included in calculation. Missing data at endpoint was imputed using LOCF approach.||percentage of subjects|||Number
796915|NCT00935532|Secondary|Percentage of Subjects Achieving HbA1c<=7%|Percentage of subjects achieving HbA1c <=7.0% (for subjects with HbA1c >7% at baseline)|Baseline, Week 26|FAS Population. Only subjects with baseline HbA1c > target were included in calculation. Missing data at endpoint was imputed using LOCF approach.||percentage of subjects|||Number
796916|NCT00935532|Primary|Change in HbA1c From Baseline to Endpoint (Week 26)|Change in HbA1c from baseline to endpoint (Week 26).|Baseline, Week 26|Statistical analysis of this study was performed for the full analysis set (FAS). FAS consisted of randomized patients who received administration of the study drug at least once and had measurement values after administration. Missing data at endpoint was imputed using last observation carried forward (LOCF) approach.||percentage of total hemoglobin||Standard Error|Least Squares Mean
796917|NCT00935584|Primary|Change in EMR Mouse Click Per Minute Per Visit (Median/Range)|For EMR use, we assessed the change in the average number of mouse clicks per minute per-visit, positive score indicates increased EMR use.|Baseline clinic visit and post-intervention clinic visit (over a period of 1 year)|Wilcoxon signed rank test was used to analyzed the subjects using complete data (n=56 for the outcomes reported below) only and mixed model method was used to analyze the subjects (n=119) using all available data.||EMR mouse clicks per minute per visit||Full Range|Median
796918|NCT00935584|Primary|Change in EMR Mouse Click Per Minute Per Visit (Mean/SD)||Baseline clinic visit and post-intervention clinic visit (over a period of 1 year)|Wilcoxon signed rank test was used to analyzed the subjects using complete data (n=56 for the outcomes reported below) only and mixed model method was used to analyze the subjects (n=119) using all available data.||EMR mouse clicks per minute per visit||Standard Deviation|Mean
796919|NCT00935584|Primary|Change in Total Number of EMR Mouse Click Per Visit (Median/Range)|For EMR use, we assessed the change in total number of mouse click per-visit, positive score indicates increased EMR use.|Baseline clinic visit and post-intervention clinic visit (over a period of 1 year)|Wilcoxon signed rank test was used to analyzed the subjects using complete data (n=60 for the outcomes reported below) only and mixed model method was used to analyze the subjects (n=119) using all available data.||EMR mouse clicks per visit||Full Range|Median
796920|NCT00935584|Primary|Change in Total Number of EMR Mouse Click Per Visit (Mean/SD)|For EMR use, we assessed the change in total number of mouse click per-visit, positive score indicates increased EMR use. Mean and standard deviation of outcome were reported in this table.|Baseline clinic visit and post-intervention clinic visit (over a period of 1 year)|Wilcoxon signed rank test was used to analyzed the subjects using complete data (n= 60 for the outcomes reported below) only and mixed model method was used to analyze the subjects (n=119) using all available data.||EMR mouse clicks per visit||Standard Deviation|Mean
796921|NCT00935584|Primary|Change in Patient Engagement|Change in proportion of time spent on physician-patient communication from pre to post-intervention clinic visit was calculated. Positive change indicates increased time spent on patient communication. Mean and standard deviation of outcomes were reported in this table.|Baseline clinic visit and post-intervention clinic visit (over a period of 1 year)|Wilcoxon signed rank test was used to analyzed the subjects using complete data (n=72 for the outcomes reported below) only and mixed model method was used to analyze the subjects (n=125) using all available data.||percentage of total visit time||Standard Deviation|Mean
796922|NCT00935584|Primary|Change in Patient's Satisfaction, Change in Provider's Satisfaction (Median/Range)|"Three patient satisfaction subscales were analyzed (range 1-5 for all subscales, 1=not satisfied at all, 5=very satisfied). Subscale 1 measures physician's use of patient center communication; Subscale 2 measures clinical competence and skills; Subscale 3 measures physician interpersonal skills. Four provider satisfaction subscales were analyzed (range 1-5 for all subscales, 1=not satisfied at all, 5=very satisfied). Subscale 1 measures quality of physician-patient relation; Subscale 2 measures patient's non-demanding co-operative nature, Subscale 3 measures satisfaction with data collection; Subscale 4 measures satisfaction with use of visit time.
Change in patient's satisfaction and change in provider's satisfaction from pre to post-intervention clinic visit was reported for the above subscales. Higher change score indicates better outcome. Median and range were reported."|Baseline clinic visit and post-intervention clinic visit (over a period of 1 year)|Wilcoxon signed rank test was used to analyzed the subjects using complete data (ranges from 63 to 73 for the outcomes reported below) only and mixed model method was used to analyze the subjects (ranges from 108 to126) using all available data.||units on a scale||Full Range|Median
796991|NCT00936208|Secondary|Change in the Framingham Score From Baseline at Week 24|The change from baseline reflects the week 24 value minus the baseline value. The Framingham score represent the cardiovascular risk and ranges from 0 (no risk) to 100% (complete risk).|Baseline and Week 24|Patients of Full Analysis Set (FAS) with values of the framingham score at baseline and at week 24||Units on a scale||Standard Deviation|Mean
796923|NCT00935584|Primary|Change in Patient's Satisfaction, Change in Provider's Satisfaction (Mean/SD)|"Three patient satisfaction subscales were analyzed (range 1-5 for all subscales, 1=not satisfied at all, 5=very satisfied). Subscale 1 measures physician's use of patient center communication; Subscale 2 measures clinical competence and skills; Subscale 3 measures physician interpersonal skills. Four provider satisfaction subscales were analyzed (range 1-5 for all subscales, 1=not satisfied at all, 5=very satisfied). Subscale 1 measures quality of physician-patient relation; Subscale 2 measures patient's non-demanding co-operative nature, Subscale 3 measures satisfaction with data collection; Subscale 4 measures satisfaction with use of visit time.
Change in patient's satisfaction and change in provider's satisfaction from pre to post-intervention clinic visit was reported for the above subscales. Higher change score indicates better outcome. Mean and standard deviation were reported."|Baseline clinic visit and post-intervention clinic visit (over a period of 1 year)|Wilcoxon signed rank test was used to analyzed the subjects using complete data (ranges from 63 to 73 for the outcomes reported below) only and mixed model method was used to analyze the subjects (ranges from 108 to126) using all available data.||units on a scale||Standard Deviation|Mean
796924|NCT00935649|Secondary|Mycology|KOH, PCR and cultures of patients who were bilaterally positive or negative for each test.|48 weeks|There was a fatal design flaw to the trial. We were advised to collect nail samples for mycologic analysis at every visit. As a result investigators were removing our primary outcome variable, increase in clear nail, at each visit. Consequently our estimates of nail growth following treatment are inaccurate and invalid.|||||
796925|NCT00935649|Primary|Nail Bed Clearing|Change in amount of clear nail over time.|48 weeks|There was a fatal design flaw to the trial. We were advised to collect nail samples for mycologic analysis at every visit. As a result investigators were removing our primary outcome variable, increase in clear nail, at each visit. Consequently our estimates of nail growth following treatment are inaccurate and invalid.|||||
796926|NCT00935701|Secondary|Change in Parenting Stress Index|The Parenting Stress Index (PSI) was designed for parents of children ages 1:6 to 12:5 and identifies stressors in the parent-child relationship. Specifically, the PSI measures child’s characteristics on six subscales, which are summed get a total score in the child domain (47 to 235). The PSI also has seven subscales that measure parent characteristics, and are summed to get a total score in the parent domain (54 to 270). The totals from the parent and child domains are summed for a total stress score (101 to 505). Higher scores indicate a higher level of stress. Pre scores were subtracted from post scores in order to get the change in scores.|Pre intervention (baseline), post intervention (8 weeks)|||units on a scale||Standard Deviation|Mean
796927|NCT00935701|Secondary|Change in Children's Sleep Habits Questionnaire|The Children’s Sleep Habits Questionnaire (CSHQ) assesses sleep problems common in school-age children and is comprised of eight subscales. Each item receives a score from 1 (meaning the problem occurs rarely) to 3 (meaning the problem usually occurs); therefore, a higher score is the worse outcome. Scale ranges are as follows: Bedtime Resistance: 6 to 18, Sleep Onset Delay: 1 to 3, Sleep Duration: 3 to 9, Sleep Anxiety: 4 to 12, Night Wakings: 3 to 9, Parasomnias: 7 to 21, Disordered Breathing: 3 to 9, Daytime Sleepiness: 8 to 24, and Total Disturbance (items from all scales): 33 to 99. Subscale scores from pre intervention were subtracted from post subscale scores in order to get the change in scores.|Pre intervention (baseline), post intervention (8 weeks)|||units on a scale||Standard Deviation|Mean
796928|NCT00935701|Secondary|Change in Conners' Rating Scales|The Conners’ Rating Scales Revised (CRS-R) is used to assess attention deficit hyperactivity disorder (ADHD) as well as other related behavioral concerns. The CRS-R is made up of 14 scales. Analysis was done on 6 of these scales: Conners' Global Index Restless-Impulsive, Conners' Global Index Emotional Lability, Conners' Global Index Total, DSM-IV Inattentive, DSM-IV Hyperactive-Impulsive, and DSM-IV Total. Raw scores are converted to T-scores, based on age and gender of the child. A high T-score indicates a greater number and/or frequency of reported concerns. Pre T-scores were subtracted from post T-scores to calculate the change in T-score.|Pre intervention (baseline), post intervention (8 weeks)|||t-scores||Standard Deviation|Mean
796929|NCT00935701|Primary|Proportions of Children Completing Acupressure and Acupuncture Treatment.||2 months into Phase 1|Participants who transitioned from acupressure to acupuncture were assessed.||participants|||Number
796930|NCT00935766|Primary|Change in Pulse Wave Velocity in Active vs. Placebo-treated Patients.|We conducted a prospective, randomized; double-blinded study of omega-3 fatty acids among 60 Latino and White hypertensive patients at risk for CVD. Patients received either 4-g omega–3 fatty acids or matched placebo daily. The principal outcome measure was change in brachial-ankle PWV.|Baseline, 3 months|||cm/sec||Standard Deviation|Mean
796931|NCT00935766|Secondary|Change in hsCRP||baseline, 3 months|||mg/L||Standard Deviation|Mean
796932|NCT00935766|Secondary|Change in Lipoprotein-associated Phospholipase A2 (LpPLA2)||baseline, 3 months|||ng/mL||Standard Deviation|Mean
796933|NCT00935792|Secondary|Time to Subsequent Therapy||up to 5 years|||Months||95% Confidence Interval|Median
796934|NCT00935792|Secondary|Duration of Response|Duration of response is defined for all evaluable patients who have achieved a clinical response as the date at which the patient’s objective status is first noted to be a Complete Response or Partial Response to the earliest date progression is documented. The distribution of duration of response will be estimated using the method of Kaplan-Meier|up to 5 years|These are 8 patients with verified complete or partial responses(used in primary outcome measure) as well as 2 non verified partial responses.||Months||95% Confidence Interval|Median
796935|NCT00935792|Secondary|Progression-free Survival|Progression-free survival time is defined as the time from registration to progression or death due to any cause. The distribution of progression-free survival will be estimated using the method of Kaplan-Meier|up to 5 years|||Months||95% Confidence Interval|Median
796936|NCT00935792|Secondary|Survival Time|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier|up to 5 years|||Months||95% Confidence Interval|Median
796937|NCT00935792|Primary|Test the Safety and Tolerability of the Combination of Everolimus and Alemtuzumab.|The number and severity of all adverse events will be tabulated and summarized in this patient population. The grade 3+ adverse events will also be described and summarized in a similar fashion. This will provide an indication of the level of tolerance for this treatment combination in this patient group. Below is the number of patients that experienced a grade 3+ Adverse event that was at least possibly related to Treatment.|Up to 12 months past final treatment|||participants|||Number
796938|NCT00935792|Primary|Number of Participants With Dose-Limiting Toxicities|"The maximum tolerated dose is the dose level below the lowest dose that induces dose-limiting toxicity in at least one-third of patients. A total of 6 patients treated at the MTD will be sufficient to identify common toxicities at the MTD. Dose-limiting toxicity will be defined as an adverse event attributed (definitely, probably, or possibly) to the study treatment and meeting the following criteria.
Hematologic: ANC ≤ 0.3 x 109/L or platelet count < 10 x 109/L Other nonhematologic: ≥grade 3 as per NCI Common Terminology Criteria for Adverse Events v3.0 except for fatigue, hyperlipidemia, and hyperglycemia."|1 Month|All phase 1 patients are evaluable||participants with DLTs|||Number
796939|NCT00935792|Primary|Clinical Response (Complete or Partial Remission)|CR requires all of the following for a period of at least 2months:Absence of lymphadenopathy.No hepatomegaly or splenomegaly.Absence of constitutional symptoms.• Neutrophils>1500/ul•Platelets>100,000/ul • Hemoglobin >11.0gm/dl• Peripheral blood lymphocytes <4000/uLBonemarrow. normocellular with<30%of nucleated cells being lymphocytes.PR requires two for 2+months.≥50%decrease in peripheral blood lymphocyte count from the pretreatment baseline value.≥ 50%reduction in the sum of the products of the maximal perpendicular diameters of the largest measured node or nodal masses in the right and left cervical, axillary, and inguinal lymph node regions.≥ 50%reduction in size of liver and/or spleen noting the maximal distance below the respective costal margins of palpable hepatosplenomegaly during rest.Neutrophils>1500/ul or50%improvement over baseline. Platelets>100,000/ul or50%increase over baseline. Hemoglobin>11.0 gm/dl or50%increase over baseline without transfusions|After 2 courses of treatment|All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response.||participants|||Number
796940|NCT00935818|Secondary|Point Prevalence Abstinence at 12 Months|Biochemically confirmed abstinence defined as no smoking, not even a puff, in the last 7 days|12 months|||participants|||Number
796941|NCT00935818|Secondary|Prolonged Abstinence at 12 Months||12 months|intention to treat - all subjects||participants|||Number
796942|NCT00935818|Secondary|Point Prevalence Abstinence at 6 Months.|Biochemically confirmed abstinence as no smoking, even a puff, for the prior 7 days.|6 months|Intention to treat - all subjects||participants|||Number
796943|NCT00935818|Primary|Point Prevalence Abstinence at 3 Months.|biochemically confirmed 7-day point prevalence abstinence defined as no smoking, not even a puff, in the previous 7 days.|3 months|intent to treat - all subjects||participants|||Number
796944|NCT00935818|Secondary|Weight Gain From Baseline to 3 Months|Weight change from baseline to three months in those who met criteria for prolonged abstinence at the 3 month visit|3 months|analysis was restricted to subjects who had weight measured at the 3 month visit and were classified as meeting criteria for prolonged abstinence||kilograms||Standard Deviation|Mean
796945|NCT00935818|Secondary|Prolonged Smoking Abstinence Rates at 26 Weeks in Cigarettes Smokers.||6 months|intention to treat - all subjects||participants|||Number
796946|NCT00935818|Primary|Prolonged Smoking Abstinence Rates at 12 Weeks in Cigarettes Smokers.|Prolonged smoking abstinence is defined as no smoking, not even a puff, in the last 7 days, and a negative response to the question “Since 2 weeks after your target quit date, have you smoked any tobacco, even a puff, for 7 consecutive days or at least once each week on 2 consecutive weeks?”|3 months|intention-to-treat (all randomized subjects included)||participants|||Number
796947|NCT00935857|Secondary|Procedural Complications|Number of patients with any procedural complications as assessed 7 days after procedure.|7 days post procedure|||participants|||Number
796948|NCT00935857|Secondary|Time (Minutes) to Cecum|Time, in minutes, until reaching cecum in each arm.|Day of Procedure|||minutes||Standard Deviation|Mean
796949|NCT00935857|Primary|Complete Colonoscopy to the Cecum|Number of patients with a complete colonoscopy to the cecum|Day of Procedure|Per Protocol, Terminated at Interim Analysis||patients|||Number
796950|NCT00935883|Secondary|Change in Visual Acuity for Geographic Atrophy Group|Visual function was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better functioning. Maximum score would be 100 letters read and minimum would be count fingers, hand motion and light perception if there were no letters read on the chart.|Baseline/ 6 Months|Geographic Atrophy Cohort included 10 eyes randomized to saline and 20 eyes randomized to Eculizumab||letters||Standard Deviation|Mean
796951|NCT00935883|Primary|Decrease in Drusen Volume||6 Months|Drusen Cohort included 10 eyes randomized to saline and 20 eyes randomized to Eculizumab||mm^3||Standard Deviation|Mean
796952|NCT00935883|Secondary|Change in Visual Acuity for Drusen Group|Visual function was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better functioning. Maximum score would be 100 letters read and minimum would be count fingers, hand motion and light perception if there were no letters read on the chart.|Baseline/ 6 Months|Drusen Cohort included 10 eyes randomized to saline and 20 eyes randomized to Eculizumab||letters||Standard Deviation|Mean
796953|NCT00935883|Primary|Growth of Geographic Atrophy||6 months|Geographic Atrophy Cohort included 10 eyes randomized to saline and 20 eyes randomized to Eculizumab||millimeters||Standard Deviation|Mean
796954|NCT00936065|Secondary|"Change From Baseline in the Percentage of Participants Who Responded Yes to Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 18, at Weeks 2, 4, 8, 12, 18 and 24"|"Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to answer the following question with either a yes or no, Taking into account your psoriasis symptoms, the appearance of your skin, medicine side effects and medicine ease/difficulty of use, do you consider that your current psoriasis treatment is satisfactory? Percentage of participants who responded yes reported."|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF||percentage of participants||95% Confidence Interval|Number
796955|NCT00936065|Secondary|"Change From Baseline in the Percentage of Participants Who Responded Yes to the Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 17, at Weeks 2, 4, 8, 12, 18 and 24"|"Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to answer the following question with either a yes or no, Taking into account your psoriasis symptoms, the appearance of your skin and all other problems which psoriasis causes, do you consider that your current health state is satisfactory? Percentage of participants who responded yes reported."|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF||Percentage of participants||95% Confidence Interval|Number
796956|NCT00936065|Secondary|Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 16, at Weeks 2, 4, 8, 12, 18 and 24|"Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to respond to the statement I would like to continue with my current psoriasis treatment. Responses were based on a 5-point scale: strongly disagree (0), disagree(1), neither agree nor disagree (2), agree (3), strongly agree (4). Change = Week X minus Baseline, where larger scores indicate improvement."|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF||Units on a scale||Standard Deviation|Mean
796957|NCT00936065|Secondary|Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 15, at Weeks 2, 4, 8, 12, 18 and 24|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: very dissatisfied (0), dissatisfied (1), neither satisfied nor dissatisfied (2), satisfied (3), very satisfied (4). Change = Week X minus Baseline, where larger scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF||Units on a scale||Standard Deviation|Mean
796958|NCT00936065|Secondary|Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 14, at Weeks 2, 4, 8, 12, 18 and 24|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on how their skin affected social and leisure activities. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF||Units on a scale||Standard Deviation|Mean
796959|NCT00936065|Secondary|Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 13, at Weeks 2, 4, 8, 12, 18 and 24|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on how others responded to their personal appearance at work/school. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF||Units on a scale||Standard Deviation|Mean
796960|NCT00936065|Secondary|Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 12, at Weeks 2, 4, 8, 12, 18 and 24|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on their fatigue. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF||Units on a scale||Standard Deviation|Mean
796961|NCT00936065|Secondary|Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 11, at Weeks 2, 4, 8, 12, 18 and 24|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on their depression. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF||Units on a scale||Standard Deviation|Mean
796962|NCT00936065|Secondary|Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 10, at Weeks 2, 4, 8, 12, 18 and 24|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on their anxiety. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF||Units on a scale||Standard Deviation|Mean
796963|NCT00936065|Secondary|Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 9, at Weeks 2, 4, 8, 12, 18 and 24|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on their comfort level with their personal appearance. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF||Units on a scale||Standard Deviation|Mean
796964|NCT00936065|Secondary|Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 8, at Weeks 2, 4, 8, 12, 18 and 24|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on joint pain. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF||Units on a scale||Standard Deviation|Mean
796965|NCT00936065|Secondary|Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 7, at Weeks 2, 4, 8, 12, 18 and 24|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on skin pain. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF||Units on a scale||Standard Deviation|Mean
798358|NCT00939211|Secondary|Forced Expiratory Volume in One Second (FEV1), Average Effect Over 0 - 24 Hours Post Dose|Average FEV1 value|0, 15 min, 30 min, 60 min, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h|||L||Standard Deviation|Mean
796966|NCT00936065|Secondary|Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 6, at Weeks 2, 4, 8, 12, 18 and 24|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on burning sensation of the skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF||Units on a scale||Standard Deviation|Mean
796967|NCT00936065|Secondary|Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 5, at Weeks 2, 4, 8, 12, 18 and 24|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on bleeding of the skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF||Units on a scale||Standard Deviation|Mean
796968|NCT00936065|Secondary|Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 4, at Weeks 2, 4, 8, 12, 18 and 24|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on tightness in the skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF||Units on a scale||Standard Deviation|Mean
796969|NCT00936065|Secondary|Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 3, at Weeks 2, 4, 8, 12, 18 and 24|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on the redness of their skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF||Units on a scale||Standard Deviation|Mean
796970|NCT00936065|Secondary|Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 2, at Weeks 2, 4, 8, 12, 18 and 24|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on the flaking of their skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF||Units on a scale||Standard Deviation|Mean
796971|NCT00936065|Secondary|Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 1, at Weeks 2, 4, 8, 12, 18 and 24|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the overall appearance of their skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF||Units on a scale||Standard Deviation|Mean
796972|NCT00936065|Secondary|Change From Baseline in SGA of Itching at Each Visit|Participants were asked to rate the severity of their psoriasis itching on a 6-point scale, where 0=good and 5=severe. Change = Week X minus Baseline, where smaller scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12 ,18 and 24|mITT; LOCF; Number of participants analyzed (N)= participants with evaluable data||units on a scale||Standard Deviation|Mean
796973|NCT00936065|Secondary|Change From Baseline in SGA of Psoriasis at Weeks 2, 4, 8, 12 ,18 and 24|Participants were asked to rate the severity of their psoriasis disease activity on a 6-point scale, where 0=good and 5=severe. Change = Week X minus Baseline, where smaller scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12 ,18 and 24|mITT; LOCF; Number of participants analyzed (N)= participants with evaluable data||units on a scale||Standard Deviation|Mean
796974|NCT00936065|Secondary|Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Weeks 2, 4, 8, 12 ,18 and 24|Participants were asked to rate the severity of their joint pain on a 6-point scale, where 0=good and 5=severe. Change = Week X minus Baseline, where smaller scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF; Number of participants analyzed (N)= participants with evaluable data||units on a scale||Standard Deviation|Mean
796975|NCT00936065|Secondary|Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Weeks 2, 4, 8, 12, 18 and 24|Change from Baseline in the percentage of the surface area of the body affected by psoriasis. Change = Week x minus Baseline, where smaller scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF||percentage of BSA||Standard Deviation|Mean
796976|NCT00936065|Secondary|Change From Baseline in the PASI Score|Combined assessment of lesion severity, area affected into single score; range:0(no disease) to 72(maximal disease).Body divided into 4 sections (head, arms, trunk, legs); each area scored by itself and scores combined for final PASI. For each section, area of skin involved was estimated:0(0%) to 6(90–100%), severity estimated by clinical signs: erythema, induration, desquamation; scale: 0(none) to 4(maximum). Final PASI = sum of severity parameters for each section * area score * weight of section(head:0.1,arm:0.2,body: 0.3, leg:0.4). Change=Week X-Baseline, smaller scores show improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF||units on a scale||Standard Deviation|Mean
796977|NCT00936065|Secondary|Change From Baseline in the PGA of Psoriasis|PGA of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Assessment of clear = PGA score of 0 (no evidence). Change = Week x, minus Baseline, where smaller scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18, and 24|mITT; LOCF||units on a scale||Standard Deviation|Mean
796978|NCT00936065|Secondary|Time to Achieve a Status on the PGA of Psoriasis of Clear or Almost Clear|PGA of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Assessment of clear or almost clear = PGA score of 0 (no evidence), or 1 (minimal/faint).|Baseline up to Week 24|mITT||days||95% Confidence Interval|Median
796979|NCT00936065|Secondary|Time to Achieve a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild|PGA of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Assessment of clear or almost clear or mild = PGA score of 0 (no evidence), 1 (minimal/faint), or 2 (mild).|Baseline up to Week 24|mITT||days||95% Confidence Interval|Median
796980|NCT00936065|Secondary|Time to Achieve a PASI 75 Score|PASI 75 defined as a 75% or greater improvement in PASI score from Baseline|Baseline up to Week 24|mITT||days||95% Confidence Interval|Median
796981|NCT00936065|Secondary|Time to Achieve a PASI 50 Score|PASI 50 defined as a 50% or greater improvement in PASI score from Baseline|Baseline up to Week 24|mITT||days||95% Confidence Interval|Median
796982|NCT00936065|Secondary|Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild|PGA of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Assessment of clear or almost clear or mild = PGA score of 0 (no evidence), 1 (minimal/faint), 2 (mild).|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF||percentage of participants||95% Confidence Interval|Number
796983|NCT00936065|Secondary|Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear|PGA of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Assessment of clear or almost clear = PGA score of 0 (no evidence), or 1 (minimal/faint).|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF||percentage of participants||95% Confidence Interval|Number
796984|NCT00936065|Secondary|Percentage of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Clear|PGA of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Assessment of clear = PGA score of 0 (no evidence).|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF||Percentage of participants||95% Confidence Interval|Number
796985|NCT00936065|Secondary|Percentage of Participants Achieving a 50% Improvement in Psoriasis Area and Severity Index (PASI 50) Score|Combined assessment of lesion severity and area affected into single score; range: 0 (no disease) to 72 (maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area scored by itself and scores combined for final PASI. For each section, area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (exceptionally striking). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).|Weeks 2, 4, 8, 12, 18, and 24|mITT; LOCF||percentage of participants||95% Confidence Interval|Number
796986|NCT00936065|Primary|Percentage of Participants Achieving a 75 Percent (%) Improvement in Psoriasis Area and Severity Index (PASI 75) Score at Week 24|Combined assessment of lesion severity and area affected into single score; range: 0 (no disease) to 72 (maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area scored by itself and scores combined for final PASI. For each section, area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (exceptionally striking). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).|Week 24|Modified intent to treat (mITT) population: randomized participants who took at least 1 dose of test article and had both baseline and on-therapy PASI evaluations; Last Observation Carried Forward (LOCF)||percentage of participants||95% Confidence Interval|Number
796987|NCT00936117|Primary|Maximum Observed Concentration in Plasma (Cmax)|"Pharmacokinetic samples were obtained on day 1, day 3 and day 10 of prophylaxis. A total of 15 samples (3 ml each sample) per participant were obtained, with thrice daily dosing planned around standard meal times. On day 1 and day 3 of prophylaxis sampling was done pre dose (0), and at 3, 5, 10 and 24 hours (±10 minutes) post dose from the time of the first dose of the day. On day 10 of prophylaxis sampling was done pre dose (0), and at 3, 5, and 10 hours (±10 minutes) post dose from the time of the first dose of the day.
Posaconazole levels were assayed by high performance liquid chromatography (HPLC). The testing range for posaconazole is from 125 – 5000 ng/ml. There are no established therapeutic ranges for posaconazole."|Pharmacokinetics: Day 1, Day 3 and Day 10 of prophylaxis.|Of the 11 females enrolled, one was not evaluable for the outcome thus excluded from analysis.||ng/ml||Full Range|Median
796988|NCT00936208|Secondary|Change From Baseline in Urinary Microalbuminuria (Urine Dipstick Test Results)|The change from baseline reflects the shift from baseline in urinary dipstick test results to week 24|Baseline and Week 24|Patients of Full Analysis Set (FAS) with values of the dipstick test at baseline and at week 24||participants|||Number
796989|NCT00936208|Secondary|Change in the IRIS II Score From Baseline at Week 24|The change from baseline reflects the week 24 value minus the baseline value. The IRIS II score represent the risk for vascular complication in type to diabetes mellitus and ranges from 0 (no risk) to 100% (complete risk).|Baseline and Week 24|Patients of Full Analysis Set (FAS) with values of the IRIS II score at baseline and at week 24||Units on a scale||Standard Deviation|Mean
796990|NCT00936208|Secondary|International Renal Interest Society (IRIS) II Score at Week 24|The IRIS II score represent the risk for vascular complication in type to diabetes mellitus and ranges from 0 (no risk) to 100% (complete risk).|Week 24|Patients of Full Analysis Set (FAS) with values of the IRIS II score at baseline and at week 24||Units on a scale||Standard Deviation|Mean
796992|NCT00936208|Secondary|Framingham Score at Week 24|The Framingham score represent the cardiovascular risk and ranges from 0 (no risk) to 100% (complete risk).|Week 24|Patients of Full Analysis Set (FAS) with values of the framingham score at baseline and at week 24||Units on a scale||Standard Deviation|Mean
796993|NCT00936208|Primary|Change in Systolic Blood Pressure From Baseline at Week 24|The change from baseline reflects the week 24 value minus the baseline value.|Baseline and Week 24|Full Analysis Set (FAS): Patients with Blood Pressure data available at baseline and at week 24||mmHg||Standard Deviation|Mean
796994|NCT00936208|Primary|Change in Diastolic Blood Pressure From Baseline at Week 24|The change from baseline reflects the week 24 value minus the baseline value.|Baseline and Week 24|Full Analysis Set (FAS): Patients with Blood Pressure data available at baseline and at week 24||mmHg||Standard Deviation|Mean
796995|NCT00936221|Secondary|Change in Target Lesion Tumour Size at Week 12||randomization to week 12|Intention to Treat (ITT)||% change||Full Range|Median
796996|NCT00936221|Secondary|Objective Response Rate|ORR rate is defined as the number (%) of subjects with at least one visit response of Complete Response (CR) or Partial Response (PR) , as defined by Response Evaluation Criteria in Solid Tumours (RECIST v1.1) for target lesions and assessed by CT or MRI. CR, Disappearance of all target lesions; PR, ≥30% decrease in the sum of the longest diameter of target lesions. Data obtained up until progression, or last evaluable assessment in the absence of progression, was included in the assessment of ORR|From randomization until evidence of RECIST-defined objective disease progression or data cut off, for a minimum of 12 months since start of treatment|Intention to Treat (ITT)||Participants|||Number
796997|NCT00936221|Secondary|Progression Free Survival|PFS is the time from randomisation until the date of objective disease progression as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) or death (by any cause in the absence of progression). Progression is defined using RECIST (v1.1), as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm.|From randomization until evidence of RECIST-defined objective disease progression or data cut off, for a minimum of 12 months since start of treatment|Intention to Treat (ITT)||Days||Full Range|Median
796998|NCT00936221|Primary|Overall Survival|Following progression survival data was collected until documentation of death, withdrawal of consent, loss to follow-up or the final data cut-off, whichever occurred first.|From date of randomization until death, withdrawal of consent or the end of the study. The end of the study was defined as the date all AZD6244 patients had been followed for a minimum of 12 months, or the date of final analysis, whichever was later|Intention to Treat (ITT)||Days||Full Range|Median
796999|NCT00936351|Primary|Weeks|Vocational rehabilitation staff tracked weekly work hours verified by supervisors and reported the data to study staff during the 24-week interventions. Therefore possible values for total weeks worked range from 1-24.|weeks 1-24|||total number of weeks||Standard Deviation|Mean
797000|NCT00936351|Primary|Work Behavior Inventory|"The Work Behavior Inventory (WBI: Bryson, et al., 1997) assesses work performance for persons with severe mental illness based on a trained rater’s observation of participants at work and an interview with their supervisor. Each of the 35 WBI items are rated as 1- 5 (“persistent problem area” to “frequent area of strength”). The total score is the sum of five sub-scales (social skills, cooperativeness, work habits, work quality, and personal presentation). We divided the total score by 35 to produce a mean score that is conducive to interpretation since there are no established cut-offs for interpretation of the total score. Thus the mean scores range from 1-5 and are interpretable based on the anchors for the likert scale ranging from 1 (persistent problem area to 5 (frequent area of strength). Good to excellent interrater reliability was found for raters in this study, with intraclass correlations of .79-.98."|week 24|||units on a scale||Standard Deviation|Mean
797001|NCT00936351|Primary|Hours|total hours worked over the duration of the 24-week treatment|week 1 through week 24 of treatment|3 participants were not included due to early dropout||total hours worked during treatment||Standard Deviation|Mean
797002|NCT00936377|Secondary|ICU Length of Stay||The duration of ICU stay in days as measured at time of hospital discharge, for up to 24 weeks|||days||Inter-Quartile Range|Median
797003|NCT00936377|Secondary|Duration of Study Drug Administration||The duration of study drug in hours as measured when the subject was discharged from the ICU, for up to 24 weeks|||hours||Inter-Quartile Range|Median
797004|NCT00936377|Secondary|Plasma Epinephrine Concentrations Across Groups Over Time|Plasma epinephrine concentrations|Four days with samples measured prior to study drug and 48 and 96 hours after starting study drug|||ng/mL||Standard Deviation|Mean
797005|NCT00936377|Secondary|The Occurrence of Adverse Events.|Occurrence of hypotension or bradycardia while on study drug|Seven days|||participants|||Number
797006|NCT00936377|Secondary|The Degree of Alcohol Withdrawal Assessed by Clinical Institute Withdrawal Assessment (CIWA) Scores|Proportion of clinical institute withdrawal assessment (CIWA) Scores listed as severe or moderate 24 Hours after Starting Study Drug. All subjects had at least four CIWA assessments.The CIWA is a ten item scale with each item on the scale scored independently on a 0-7 or 0-4 scale, and the summation of the scores yielding an aggregate value that correlates to the severity of alcohol withdrawal. Ranges of scores are from 0 to 67. Mild alcohol withdrawal is defined with a score less than or equal to 15, moderate with scores of 16 to 20, and severe with any score greater than 20. The ten items evaluated include nausea and vomiting, tremor, sweats, anxiety, agitation, tactile disturbances, auditory disturbances, visual disturbances, headache, and orientation.|Every 2-4 hours for 24 hours after starting study drug|||percentage of ciwa assessment|||Number
797007|NCT00936377|Primary|Change in 24-Hour Lorazepam Requirement Pre- and Post-Treatment||24 hours before treatment, 24 hours after treatment on first day of starting study drug|||mg||Inter-Quartile Range|Median
797008|NCT00936377|Primary|Change in 12-Hour Lorazepam Requirement Pre- and Post-Treatment||12 hours before treatment, 12 hours after treatment on first day of starting study drug|||mg||Inter-Quartile Range|Median
797009|NCT00936377|Primary|Cumulative Lorazepam Dose Over the First Seven Days of Alcohol Withdrawal||Seven days|||mg||Inter-Quartile Range|Median
797041|NCT00936975|Primary|Changes in 18F-fluoride PET (SUV) - Tumor Bone|Investigation of changes between baseline and 12 weeks in regional fluoride incorporation as measured by 18F-fluoride PET in tumor bone as measured by SUVmax|Baseline and 12 weeks|Analysis population consists of 37 bone locations in 12 participants who were eligible for the study and had interpretable Pre- and Post-Treatment PET scans||SUVmax|Participants|Standard Deviation|Mean
797010|NCT00936455|Secondary|Functional Outcome (mRS(0-1)) at 12 Months After Index Event. The mRS is the Modified Rankin Scale That Measures Patient's Functional Level of Activity. The Scale is a 6 Point Scale With 0 Score Being Normal and 6 Score Being Death.|Functional Outcome (mRS(0-1)) at 12 months after index event. The mRS is the modified Rankin Scale that measures patient's functional level of activity. The scale is a 6 point scale with 0 score being normal and 6 score being death. Listed below is the number of participants in each group with Functional Outcome (mRS(0-1)).|Patients were all assessed at a single time point (July 2009) for retrospective reporting of how they were at 12 months since initial event (2ndary endpoint). The average time per participant relative to the study entry time in units is 12 months|NUMBER OF PARTICIPANTS WAS DETERMINED BASED ON PER PROTOCOL NUMBER OF PATIENT ABLE TO BE CONTACTED VIA TELEPHONE||participants|||Number
797011|NCT00936455|Secondary|Recurrent Stroke|Assessing amount of patients that had recurrent stroke by 12 months (patients that retrospectively reporting having had a stroke from 6-12 months after their index event)|Patients were all assessed at a single time point (July 2009) for retrospective reporting of how they were at 12 months since initial event (2ndary endpoint). The average time per participant relative to the study entry time in units is 12 months|NUMBER OF PARTICIPANTS WAS DETERMINED BASED ON PER PROTOCOL NUMBER OF PATIENT ABLE TO BE CONTACTED VIA TELEPHONE||participants|||Number
797012|NCT00936455|Secondary|Recurrent Stroke|Assessing amount of patients that had recurrent stroke by 6 months (patients that retrospectively reporting having had a stroke from 0-6 months after their index event)|Patients were all assessed at a single time point (July 2009) for retrospective reporting of how they were at 6 months since initial event (Primary endpoint). The average time per participant relative to the study entry time in concrete units is 6 months|NUMBER OF PARTICIPANTS WAS DETERMINED BASED ON PER PROTOCOL NUMBER OF PATIENT ABLE TO BE CONTACTED VIA TELEPHONE||participants|||Number
797013|NCT00936455|Primary|Functional Outcome (mRS(0-1)) at 6 Months After Index Event. The mRS is the Modified Rankin Scale That Measures Patient's Functional Level of Activity. The Scale is a 6 Point Scale With 0 Score Being Normal and 6 Score Being Death.|Functional Outcome (mRS(0-1)) at 6 months after index event. The mRS is the modified Rankin Scale that measures patient's functional level of activity. The scale is a 6 point scale with 0 score being normal and 6 score being death. Listed below is the number of participants in each group with Functional Outcome (mRS(0-1)).|Patients were all assessed at a single time point (July 2009) for retrospective reporting of how they were at 6 months since initial event (Primary endpoint). The average time per participant relative to the study entry time in concrete units is 6 months|NUMBER OF PARTICIPANTS WAS DETERMINED BASED ON PER PROTOCOL NUMBER OF PATIENT ABLE TO BE CONTACTED VIA TELEPHONE||participants|||Number
797014|NCT00936481|Secondary|Comparison of Endothelial (Blood Vessel) Wall Diameter in Patients With Obstructive Sleep Apnea Versus Controls.||at initial visit|||mm||Standard Deviation|Mean
797015|NCT00936481|Primary|Comparison of Levels of Mean PAI-1 Activity in Patients With Obstructive Sleep Apnea and Controls.||at the initial visit|||IU/ml||Standard Error|Mean
797016|NCT00936585|Primary|Immunologic Data|Changes in immunological parameters in blood and lamina propria immune cells|Baseline, 6 weeks|All patients in the study were enrolled; not enough patients were enrolled to get enough data to analyze - THERE IS NO DATA as the samples were not processed because not enough patients were enrolled to make any comparison.|||||
797017|NCT00936598|Secondary|Daily Analgesic Medication Consumption (Morphine Equivalency)|Analgesic medication consumption will be calculated (morphine equivalent daily dose (MEDD)) on a daily basis using data down loaded from the patient-controlled analgesia (PCA) pump supplemented by information from clinical charts and patient self report on the daily diary form. MEDD starts at zero and does not have an upper limit; higher daily doses indicate more analgesic medication consumption, and thus more pain.|daily from the day of surgery until the clinical follow-up appointment|Due to limited enrollment in this study, and the small amount of data collected, we are unable to produce any significant results or conclusions.|||||
797018|NCT00936598|Secondary|Pain Severity Visual Analogue Scale|"Pain severity will be assessed daily following surgery with a visual analogue scale (VAS) completed by participants each night before they go to bed (daily diary PM). VAS pain severity yields a score of 0 to 100, with 100 indicating pain as bad as it could be."|each of the days following surgery until the clinical follow-up appointment|Due to limited enrollment in this study, and the small amount of data collected, we are unable to produce any significant results or conclusions.|||||
797019|NCT00936598|Primary|Brief Pain Inventory (Short-form)|Pain intensity and pain interference subscales from the Brief Pain Inventory (Short-form) (BPI) will be used to measure pain over the interval following surgery. Both subscales have a range of 0-10 with higher scores indicating worse outcomes (more intense pain and more pain interference).|at the clinical follow-up appointment approximately 7-10 days after surgery|Due to limited enrollment in this study, and the small amount of data collected, we are unable to produce any significant results or conclusions.|||||
797020|NCT00936702|Secondary|Time to Treatment Failure|Time to treatment failure was defined to be the time from the date of registration to the date at which the participant is removed from treatment due to progression, adverse events, or refusal.|Up to 3 years|All participant who has been removed from treatment due to progression, adverse events, or refusal.||months||95% Confidence Interval|Median
797021|NCT00936702|Secondary|Duration of Response|Duration of response was defined for all evaluable participants who have achieved an objective response as the date at which the participant's objective status is first noted to be either CR or PR to the date progression is documented.|Up to 3 years|All eligible participants who have achieved an objective response at which the participant's objective status is first noted to be either CR or PR.||months||95% Confidence Interval|Median
797022|NCT00936702|Secondary|Progression-free Survival|The progression-free survival (PFS) was defined as the time from date of registration to the documentation of disease progression or death as a result of any cause, whichever comes first.|Time from registration to the disease progression or death (up to 3 years)|All participants except one who was deemed ineligible (treated prior to registration).||months||95% Confidence Interval|Median
797023|NCT00936702|Secondary|Overall Survival|Overall survival was defined as the time from study enrollment to the time of death from any cause or last follow-up.|Time from registration to death or last follow-up (up to 3 years)|All participants except one who was deemed ineligible (treated prior to registration).||months||95% Confidence Interval|Median
798359|NCT00939211|Primary|Forced Expiratory Volume in One Second (FEV1), Average Effect Over 22 - 26 Hours Post-dose|Trough FEV1 value|22 h, 24 h, 26 h|||L||Standard Deviation|Mean
797024|NCT00936702|Primary|Percentage of Participants With Confirmed Tumor Responses|"Confirmed tumor response was defined to be either a complete response (CR) or partial response (PR) noted as the objective status on 2 consecutive evaluations at least 4 weeks apart.
Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria:
Complete Response (CR): disappearance of all target lesions;
Partial Response (PR) 30% decrease in sum of longest diameter of target lesions;"|First 6 Cycles of treatment (an average of 6 months)|All participants except one who was deemed ineligible (treated prior to registration).||percentage of participants||95% Confidence Interval|Number
797025|NCT00936715|Primary|Number of Participants Who Had Access to, and Received the Intervention|This endpoint has been included to satisfy the requirements of ClinicalTrials.gov. However, there were no prespecified endpoints in this study.|Up to 240 weeks|Participants who were enrolled into the study and received study drug.||Participants|||Count of Participants
797026|NCT00936741|Secondary|The Long-term Benefit of Mifepristone Treatment in Cushing’s Syndrome as Measured by Changes in the Score on the Physician’s Global Assessment of Disease Severity|"The mean Investigator’s rating of the change in subject’s signs and symptoms of Cushing’s syndrome from Baseline (Entry into C1073-415) to Endpoint on the Physician’s Global Assessment of Disease Severity was ranked on a 9-point scale (9 = much worse, 7 = worse, 5 = no change, 3 = better, 1 = much better). Higher scores indicate more severe illness. Scoring was done at all visits except the 6 Week Follow-up visit; the final visit result (Endpoint) is reported here.
The instruction was Rate the change in the subject’s signs and symptoms of Cushing’s from Baseline (1 = much better to 9 = much worse)."|Up to three years.|||units on a scale||Standard Deviation|Mean
797027|NCT00936741|Primary|Number of Participants With Adverse Events|Subjects who received at least one dose of mifepristone were included in the safety analysis.|Up to three years.|Subjects who received one dose of study drug were included in the safety and ITT analyses.||participants|||Number
797028|NCT00936897|Secondary|Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12||Baseline to month 12|All randomized subjects using regression imputation for missing post baseline data||Percentage Change From Baseline||95% Confidence Interval|Mean
797029|NCT00936897|Secondary|Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 12||Baseline to Month 12|All randomized subjects using regression imputation for missing post baseline data||Percentage Change From Baseline||95% Confidence Interval|Mean
797030|NCT00936897|Secondary|Serum Type-1 C-Telopeptide Percent Change From Baseline at Month 1||Baseline to month 1|Randomized subjects who enrolled in the bone marker substudy||Percentage Change From Baseline||Inter-Quartile Range|Median
797031|NCT00936897|Primary|Total Hip Bone Mineral Density Percent Change From Baseline at Month 12||Baseline to month 12|All randomized subjects using regression imputation for missing post baseline data.||Percentage Change From Baseline||95% Confidence Interval|Mean
797036|NCT00936975|Secondary|Changes in 18F-fluoride Transport (by Patlak Flux) - Normal|Investigation of changes in regional fluoride incorporation as measured by 18F-fluoride transport (Patlak flux) in normal bone. Palak flux is an indicator of blood flow and an indirect marker of angiogenesis.|Baseline and 12 weeks|||mL/min/mL|Participants|Standard Deviation|Mean
797037|NCT00936975|Primary|Changes in 18F-fluoride Ki - Normal Bone|Investigation of changes between baseline and 12 weeks in regional fluoride incorporation as measured by 18F-fluoride PET (Ki) in normal bone. Ki represents the net uptake of fluoride to the bone mineral compartment and reflects the level of osteoblastic activity in bone|Baseline and 12 weeks|Analysis population consists of 37 bone locations in 12 participants who were eligible for the study and had interpretable Pre- and Post-Treatment PET scans||mL/min/mL|Participants|Standard Deviation|Mean
797038|NCT00936975|Primary|Changes in 18F-fluoride Ki - Tumor Bone|Investigation of changes between baseline and 12 weeks in regional fluoride incorporation as measured by 18F-fluoride PET (Ki) in tumor bone. Ki represents the net uptake of fluoride to the bone mineral compartment and reflects the level of osteoblastic activity in bone|Baseline and 12 weeks|Analysis population consists of 37 Tumor bone locations in 12 participants who were eligible for the study and had interpretable Pre- and Post-Treatment PET scans||mL/min/mL|Participants|Standard Deviation|Mean
797039|NCT00936975|Primary|Changes in 18F-fluoride PET SUV - Normal Bone|Investigation of changes between baseline and 12 weeks in regional fluoride incorporation as measured by 18F-fluoride PET (SUV) in normal bone as measured by SUVmax|Baseline and 12 weeks|Analysis population consists of 37 normal bone locations in 12 participants who were eligible for the study and had interpretable Pre- and Post-Treatment PET scans||SUVmax|Participants|Standard Deviation|Mean
797040|NCT00936975|Secondary|Changes in 18F-fluoride Transport (by Patlak Flux) - Tumor|Investigation of changes in regional fluoride incorporation as measured by 18F-fluoride transport (Patlak flux) in Tumor. This measurement uses the Patlak method for determining the influx constant.|Baseline and 12 weeks|||mL/min/mL|Participants|Standard Deviation|Mean
797042|NCT00937040|Secondary|Epworth Sleepiness Scale (ESS)|The Epworth Sleepiness Scale (ESS) is an 8-item self-rated questionnaire designed to assess the overall level of daytime sleepiness. Each item describes normal daily situations (i.e., watching TV, lying down in the afternoon, sitting inactive in a public place) and subjects rate the likelihood of dozing off or falling asleep in each situation. Responses use a 4-point rating scale (0=would never doze, 1=slight chance of dozing, 2=moderate chance of dozing, 3=high chance of dozing). Item scores are summed to produce a total score (range of 0-24) with lower score suggesting more alertness.|Baseline, endpoint (42 days or early discontinuation)|Intent-to-Treat (ITT) analysis set. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint.||units on a scale||Standard Deviation|Mean
797043|NCT00937040|Secondary|Pittsburgh Sleep Quality Index (PSQI) Total Score|The PSQI discriminates between good and poor sleepers. The self-administered scale contains 15 multiple-choice items concerning frequency of sleep disturbances and subjective sleep quality and 4 write-in items that inquire about typical bedtime, wake-up time, sleep latency, and sleep duration over the past month. The PSQI generates 7 scores corresponding to the different sleep domains. Each component score ranges from 0 to 3. Total sleep index is calculated by adding up the 7 component scores (low=0, high=21, the lower the score, the better in sleep quality).|Baseline, endpoint (42 days or early discontinuation)|Intent-to-Treat (ITT) analysis set. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint.||units on a scale||Standard Deviation|Mean
797044|NCT00937040|Secondary|Adult ADHD Self-Report Scale (ASRS) Over Time|The Adult ADHD Self-Report Scale (ASRS) assesses 18 core ADHD symptoms corresponding to the DSM-IV diagnostic symptoms for adult subjects based on the subject's own rating for each of the symptoms using a four point scale (0=None, 1=Mild, 2=Moderate, and 3=Severe). If a single item is missing the score is imputed and if more than one item is missing, the total score is treated as missing. The ASRS total score is derived by summing the score assigned to each of the 18 symptoms (low=0, high=54, a higher score signifies a greater severity of symptoms).|Baseline, endpoint (42 days or early discontinuation)|Intent-to-Treat (ITT) analysis set. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint.||units on a scale||Standard Deviation|Mean
797045|NCT00937040|Secondary|Designated Observer's (DO) Rating of Satisfaction With Treatment Questionnaire - Overall, How Satisfied or Dissatisfied Are You With the Medication for ADHD Your Partner is Taking?|The satisfaction with treatment questionnaire (low=0, high=20, a lower score indicates lower satisfaction with treatment) requires the subject’s DO to answer 4 questions related to how much the subject’s ADHD symptoms have changed since starting the medication, how much benefit was received from the medication, the extent, if any, the advantages outweighed the disadvantages, and overall satisfaction with the medication. Responses vary from extremely satisfied, very satisfied, satisfied, neutral, mildly dissatisfied, dissatisfied, very dissatisfied, or extremely dissatisfied.|Endpoint (42 days or early discontinuation)|Intent-to-Treat (ITT) analysis set for non-missing response to this question||Participants|||Number
797046|NCT00937040|Secondary|Designated Observer's (DO) Rating of Dyadic Satisfaction Subscale|The Dyadic Adjustment Scale (DAS) completed by DOs who were spouses or significant others assesses the relationship satisfaction or adjustment of partners in committed couple relationships. The 32-question DAS includes 4 empirically validated subscales that measure: dyadic satisfaction, dyadic consensus, dyadic cohesion and affectional expression. Possible responses include 5-, 6-, and 7-point Likert-scale questions and two yes/no items. The 10-question DAS subset, the Dyadic Satisfaction Subscale, was used in this study (low=0, high=50, higher score means better relationship satisfaction).|Baseline, endpoint (42 days or early discontinuation)|Intent-to-Treat (ITT) analysis set. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint.||units on a scale||Standard Deviation|Mean
797047|NCT00937040|Secondary|Designated Observer's (DO) Global Executive Composite (GEC) Score of the Brief Rating Inventory of Executive Function for Adults (BRIEF-A)|The BRIEF-A, as completed by the DO, is a measure (low=61, high=225, lower scores indicate higher executive functioning) capturing views of an adult informant familiar with the subject’s functioning. The BRIEF-A contains 75 scored items (1=never, 2=sometimes, 3=often) in nine non-overlapping clinical scales (Inhibit, Shift, Emotional Control, Self-Monitor, Initiate, Working Memory, Plan/Organize, Task Monitor, and Organization of Materials). The Behavioral Regulation Index (BRI), Metacognition Index (MI), and Global Executive Composite (GEC) are then derived.|Baseline, endpoint (42 days or early discontinuation)|Intent-to-Treat (ITT) analysis set. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint.||units on a scale||Standard Deviation|Mean
797048|NCT00937040|Secondary|Significant Other's (a Spouse, Significant Other or Other Adult in the Household, Described in This Study as the Designated Observer) Rating of Adult ADHD Rating Scale IV|The ADHD Rating Scale-IV (Significant Other) is an 18-item list of core ADHD symptoms corresponding to the DSM-IV diagnostic symptoms. Each item is rated on a four point Likert type scale (0 = never or rarely, 1 = sometimes, 2 = often, and 3 = very often). The subject’s designated observer will complete this scale, with baseline assessment based on the subject’s usual functioning when not on medication. The total score is derived by summing the score assigned to each of the 18 symptoms (low=0, high=54, a higher score signifies a greater severity of symptoms).|Baseline, endpoint (42 days or early discontinuation)|Intent-to-Treat (ITT) analysis set and non-missing values at each timepoint. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint.||units on a scale||Standard Deviation|Mean
797049|NCT00937040|Secondary|Clinical Global Impression - Severity of Illness Subscale (CGI-S)|The Clinical Global Impression - Severity of Illness (CGI-S) is a clinician-rated subscale (low=0, high=7, higher score indicates increasing illness). The clinician rates the severity of the ADHD symptoms in relation to the clinician’s total experience with ADHD subjects using a 7-point scale (1=normal, not at all ill, 2= borderline ill, 3= mildly ill, 4=moderately ill, 5= markedly ill, 6= severely ill, 7= among the most extremely ill subjects) in response to the question “Considering your total clinical experience with this particular population, how ill is the subject at this time?”.|Baseline, endpoint (42 days or early discontinuation)|Intent-to-Treat (ITT) analysis set. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint.||units on a scale||Standard Deviation|Mean
797051|NCT00937040|Secondary|Subject's Rating of Satisfaction With Treatment Questionnaire - Overall, How Satisfied or Dissatisfied Are You With the Medication You Are Taking for ADHD?|The satisfaction with treatment questionnaire (low=0, high=20, a lower score indicates lower satisfaction with treatment) requires subjects to answer 4 questions related to how much their ADHD symptoms have changed since starting the medication, how much benefit they received from the medication, the extent, if any, the advantages outweighed the disadvantages, and overall satisfaction with the medication. The responses for this question vary with range of satisfaction (e.g. extremely satisfied, very satisfied, satisfied, neutral, dissatisfied, very dissatisfied, or extremely dissatisfied).|Endpoint (42 days or early discontinuation)|Intent-to-Treat (ITT) analysis set for non-missing response to this question||Participants|||Number
797052|NCT00937040|Secondary|Subject's Rating of Dyadic Satisfaction Subscale (DSS)|The Dyadic Adjustment Scale (DAS) assesses the relationship satisfaction or adjustment of partners in committed couple relationships. The 32-question DAS includes 4 empirically validated subscales that measure: dyadic satisfaction, dyadic consensus, dyadic cohesion and affectional expression. The response format varies across the entire scale and includes 5-, 6-, and 7-point Likert-scale questions and two yes/no items. The 10-question subset of the DAS, the Dyadic Satisfaction Subscale, was used in this study (low=0, high=50, higher score means better relationship satisfaction).|Baseline, endpoint (42 days or early discontinuation)|Intent-to-Treat (ITT) analysis set. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint.||units on a scale||Standard Deviation|Mean
797053|NCT00937040|Secondary|Subject's Rating of Endicott Work Productivity Scale (EWPS)|The EWPS provides a measure of the subject’s report of their overall productivity (low=0, high=100, a higher score indicates worsening work productivity and efficiency). There are 25 items (questions 15-39) on the scale that describe types of behaviors/ subjective feelings that are highly likely to reduce work productivity/efficiency. These 25 items are rated on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, to 4=almost always) indicating how often the behavior, feeling or attitude has been manifested in the past week. The total score is the sum of the 25 items.|Baseline, endpoint (42 days or early discontinuation)|Intent-to-Treat (ITT) analysis set. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint.||units on a scale||Standard Deviation|Mean
797054|NCT00937040|Secondary|Performance and Daily Functioning Scale of the Adult ADHD Impact Module (AIM-A)|The AIM-A is a subject-reported measure (low=0, high=100, a higher score is more favorable) to assess the overall impact and role that ADHD may have in the conduct of tasks that are expected of adults. The AIM-A is comprised of four global quality of life items, five economic impact items, and five multi-item scales that describe important concepts. Items include: Living with ADHD; General Well-Being; Work, Home and School Performance and Daily Functioning; Relationships; and Communication; and Impact of Symptoms (emotional, degree of daily interference).|Baseline, endpoint (42 days or early discontinuation)|Intent-to-Treat (ITT) analysis set. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint.||units on a scale||Standard Deviation|Mean
797055|NCT00937040|Secondary|Global Executive Composite (GEC) Score of the Brief Rating Inventory of Executive Function for Adults (BRIEF-A)|The BRIEF-A is a self-reported measure (low=61, high=225, lower scores indicate higher executive functioning) capturing views of the subject's own functioning in the everyday environment. The BRIEF-A contains 75 scored items (1=never, 2=sometimes, 3=often) in 9 non-overlapping clinical scales (Inhibit, Shift, Emotional Control, Self-Monitor, Initiate, Working Memory, Plan/Organize, Task Monitor, and Organization of Materials). The Behavioral Regulation Index (BRI), Metacognition Index (MI), and GEC are then derived.|Baseline, endpoint (42 days or early discontinuation)|Intent-to-Treat (ITT) analysis set. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint.||units on a scale||Standard Deviation|Mean
797056|NCT00937040|Secondary|Processing Speed Domain of the Symbol Digit Modalities Test (SDTM) (Cognitive and Executive Function)|The Symbol Digit Modalities Test (SDMT) is a computerized variant of the Wechsler Digit Symbol Substitution Test (DSST), but the position of symbols and digits is reversed. Scoring is the number of correct responses generated in 2 minutes. Processing Speed Domain = SDMT correct responses - SDMT errors. Higher scores indicate better functioning (i.e. information processing).|Baseline, endpoint (42 days or early discontinuation)|Intent-to-Treat (ITT) analysis set. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint.||acccurate responses per minute||Standard Deviation|Mean
797057|NCT00937040|Secondary|Cognitive Flexibility Domain of the Stroop/SAT Tests (Cognitive and Executive Function)|The Stroop Test is a computerized measure of inhibition/disinhibition, executive function, reaction time, and information processing. The SAT is a computerized measure of the ability to shift from one instruction set to another quickly and accurately. The scores generated by the SAT are: correct matches, errors, and response time. The testing score is a measure of cognitive flexibility. Cognitive Flexibility Domain Score = SAT Correct Responses - SAT Errors - Stroop Commission Errors. Higher scores indicate better accuracy.|Baseline, 4 hour timepoint for extended days or last non-missing value for non-extended days on day 42 or early discontinuation (endpoint)|Intent-to-Treat (ITT) analysis set. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint.||correct responses||Standard Deviation|Mean
797058|NCT00937040|Secondary|Vigilance Domain (Complex Attention) of the Stroop Test/Shifting Attention Test (SAT)/Continuous Performance Test (CPT) (Cognitive and Executive Function)|The Stroop Test is a computerized measure of inhibition/disinhibition, executive function, reaction time, and information processing. The Shifting Attention Test (SAT) a computerized measure of the ability to shift from one instruction set to another quickly and accurately. The Continuous Performance Test (CPT) is a computerized measure of vigilance or sustained attention/attention over time. Vigilance Domain (Complex Attention) Score = Stroop Commission Errors + SAT Errors + CPT Commission Errors + CPT Omission Errors. Lower scores indicate better functioning (i.e. sustained attention).|Baseline, endpoint (42 days or early discontinuation)|Intent-to-Treat (ITT) analysis set. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint.||errors||Standard Deviation|Mean
800796|NCT00960375|Primary|Abstinence From Tobacco|Self-reported abstinence from tobacco + breath CO < 10 ppm|7 days|All randomized to condition||participants|||Number
797059|NCT00937040|Secondary|Reaction Time Domain of the Stroop Test (Cognitive and Executive Function)|"Stroop Test is a computerized measure of inhibition/disinhibition, executive function, reaction time, and information processing. The 1st part generates basic reaction time to colors. The 2nd part generates complex reaction time score to matching color names and font color. The 3rd part establishes a Stroop reaction time and an error score to unmatched color names/fonts. Reaction Time Domain Score = (Stroop Complex Reaction Time Correct + Stroop Reaction Time Correct)/2. Lower scores indicate better functioning (i.e. reaction time)."|Baseline, 4 hour timepoint for extended days or last non-missing value for non-extended days on day 42 or early discontinuation (endpoint)|Intent-to-Treat (ITT) analysis set. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint.||milliseconds (msec)||Standard Deviation|Mean
797060|NCT00937040|Primary|Adult Attention Deficit Hyperactivity Disorder (ADHD) Investigator Symptom Rating Score (AISRS) Over Time Using the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Fourth Edition for Diagnosis|The Adult ADHD Investigator Symptom Rating Score (AISRS) assesses 18 core ADHD symptoms corresponding to the DSM-IV diagnostic symptoms for adult subjects based on the investigator’s rating for each of the symptoms using a four point scale (0=None, 1=Mild, 2=Moderate, and 3=Severe). If a single item is missing the score is imputed and if more than one item is missing, the total score is treated as missing. The AISRS total score is derived by summing the score assigned to each of the 18 symptoms (low=0, high=54, a higher score signifies a greater severity of symptoms).|Baseline, endpoint (42 days or early discontinuation)|Intent-to-Treat (ITT) analysis set was defined as all randomized subjects who have received at least one dose of the study medication and have any post-baseline efficacy data (not including ASRS).||units on a scale||Standard Deviation|Mean
797061|NCT00937105|Secondary|Number of Participants With CIE Stratified by CNS Microbial Bioburden on Lid Margins|Microbial bioburden with coagulase negative staphylococci (CNS) on lid margins was determined with predetermined cutoffs to identify substantial bioburden as high levels of normal CNS flora on lids|up to 1 year|All participants in which valid lids bioburden data was available||participants|||Number
797062|NCT00937105|Secondary|Number of Participants With CIE Stratified by Overall Microbial Bioburden on Lid Margins|Microbial bioburden on lid margins was determined with predetermined cutoffs to identify substantial bioburden as high levels of normal flora or presence of pathogenic abnormal flora on lids|up to 1 year|All participants in which valid lens bioburden data was available||participants|||Number
797063|NCT00937105|Secondary|Number of Participants With CIE Stratified by Microbial Bioburden on Lens Cases|Microbial bioburden within lens storage cases was determined with predetermined cutoffs to identify substantial bioburden as high levels of normal flora or presence of pathogenic abnormal flora|up to 1 year|All participants in which valid lens case bioburden data was available||participants|||Number
797064|NCT00937105|Secondary|Number of Participants With CIE Based Stratified by Presence or Absence of Corneal Staining Induced by Solution Use.|Presumed solution induced corneal staining was defined as diffuse punctate fluorescein staining of at least 15% surface area in at least 4 of 5 zones|up to 1 year|Number of participants with valid presumed solution induced corneal staining data in each group||participants|||Number
797065|NCT00937105|Secondary|Number of Participants With CIE Stratified by Microbial Bioburden on Lenses|Microbial bioburden on lenses was determined with predetermined cutoffs to identify substantial bioburden as high levels of normal flora or presence of pathogenic abnormal flora on lenses|up to 1 year|All participants in which valid lens bioburden data was available||participants|||Number
797066|NCT00937105|Primary|Number of Participants Developing a Corneal Inflammatory Event (CIE)|Raw number of participants in each solution arm developing CIE over 12 month follow-up period|up to 1 year|This primary analysis includes the cohort of all 218 randomized participants. The measured values stratify participants by solution group, however, the statistical analysis reports on the entire cohort (both solution groups) consistent with the primary aim of the study.||participants|||Number
797067|NCT00937118|Primary|Duodenal-related Complications|Duodenal-related complications including leak, obstruction, and abscess|20 years|Patients with duodenal related complications||percentage of subjects|||Number
797068|NCT00937157|Secondary|To Determine the Correlation of MTI and Cumulative Gd Enhancing Lesions Using the 1.5T and 3T Protocols.||day 0, 3, 6, 9 & 12 months||||||
797069|NCT00937157|Primary|A Decrease in the Cumulative Number of Gd Enhancing Lesions Using a 3T Protocol.||0-180 days and 0-360 days|Of the 12 RRMS patients enrolled, only the 8 who completed days 180 and 360 were analyzed. There was no imputation used.||Cumulative GAD lesions (number of)||Standard Deviation|Mean
797070|NCT00937235|Secondary|TLFB - Cigarettes Smoked Week Before 3-Month Follow-up|Timeline followback - Number of cigarettes smoked the week before 3-month follow-up visit|3-month follow-up|||Number of Cigarettes Smoked||Standard Deviation|Mean
797071|NCT00937235|Secondary|TLFB - Total Cigarettes Smoked Week Before Appointment (at Post-Treatment)|Timeline Followback - Total number of cigarettes smoked the week before Post-Treatment visit|Week before Post-Treatment visit occurring at week 12, therefore the week between Week 11 and 12|||Number of Cigarettes Smoked||Standard Deviation|Mean
797072|NCT00937235|Secondary|Hamilton Depression Scale (HAM-D) Total Score at 3-Month Follow-Up|"Hamilton Depression scale (HAM-D) at 3-month followup assessment, which measures severity of depression symptoms Total scores are displayed and represent summed scores on 17 individual items the scale, and scale range for total scores is 0 to 50.
Higher scores indicate higher/worse levels of depression."|3-month follow-up|||Scores on a scale||Standard Deviation|Mean
797073|NCT00937235|Secondary|Hamilton Depression Scale (HAM-D) Total Score at Post-Treatment|"Hamilton Depression scale (HAM-D) at post-treatment assessment, which measures severity of depression symptoms Total scores are displayed and represent summed scores on 17 individual items the scale, and scale range for total scores is 0 to 50.
Higher scores indicate higher/worse levels of depression."|Post-Treatment assessment, occurring 12 weeks after the start of treatment (week 0)|||Scores on a scale||Standard Deviation|Mean
797074|NCT00937235|Secondary|Posttraumatic Symptom Scale Interview (PSS-I) Total Score at 3-Month Follow-Up|"Posttraumatic Symptom Scale Interview at 3-month follow-up assessment, which measures severity of post-traumatic stress disorder (PTSD) symptoms Total scores are displayed and represent summed scores on 17 individual items the scale, and scale range for total scores is 0 to 51.
Higher scores indicate higher/worse levels of PTSD."|3-month follow-up|||scores on a scale||Standard Deviation|Mean
797075|NCT00937235|Secondary|Posttraumatic Symptom Scale Interview (PSS-I) at Post-Treatment|"Posttraumatic Symptom Scale Interview at post-treatment assessment, which measures severity of post-traumatic stress disorder (PTSD) symptoms Total scores are displayed and represent summed scores on 17 individual items the scale, and scale range for total scores is 0 to 51.
Higher scores indicate higher/worse levels of PTSD."|Post-treatment, occurring 12 weeks after the start of treatment (week 0)|||Scores on a scale||Standard Deviation|Mean
797076|NCT00937235|Secondary|Blood Serum Cotinine|Level of cotinine in blood|At end of 3-month follow-up|||ng/mL||Standard Deviation|Mean
797077|NCT00937235|Primary|Number of Participants With 7-day Point Prevalence Smoking Abstinence|Number of participants reporting seven-day point prevalence abstinence (PPA), which was defined as self-reported abstinence for 7 days prior to the assessment, serum cotinine level of <15ng/ml, and CO < 10 ppm.|At 3-month follow-up (6-month post-quit day)|||Participants|||Count of Participants
797078|NCT00937391|Secondary|Number of Participants With Specific Change in Management From Unenhanced to Combined Images - Stage 2|The actual change in management from unenhanced to combined images recommended by the open-label Clinical Investigators is presented in Stage 2 for the optimal efficacious dose determined in Stage 1|Within 5 minutes after injection|Full analysis set||Participants|||Number
797079|NCT00937391|Secondary|Number of Participants With Specific Change in Management From Unenhanced to Combined Images - Stage 1|The actual change in management from unenhanced to combined images recommended by the open-label Clinical Investigators is presented for both doses in Stage 1|Within 5 minutes after injection|Full analysis set||Participants|||Number
797080|NCT00937391|Secondary|Overall Number of Participants With Change in Management From Unenhanced to Combined Images - Stage 2|For Stage 2, the number of participants for whom the recommended management of the open-label Clinical Investigators changed from unenhanced to combined images is presented for the optimal efficacious dose determined in Stage 1.|Within 5 minutes after injection|Full analysis set||Participants|||Number
797081|NCT00937391|Secondary|Overall Number of Participants With Change in Management From Unenhanced to Combined Images - Stage 1|For Stage 1, the number of participants for whom the recommended management of the open-label Clinical Investigators changed from unenhanced to combined images is presented for both doses.|Within 5 minutes after injection|Full analysis set||Participants|||Number
797082|NCT00937391|Secondary|Management Based on Unenhanced Images - Stage 2|For Stage 2 based on unenhanced images, the recommended management is presented as determined by the open-label Clinical Investigators.|Within 5 minutes before injection|Full analysis set (only participants for whom information on management was given)||Participants|||Number
797083|NCT00937391|Secondary|Management Based on Unenhanced Images - Stage 1|For Stage 1 based on unenhanced images, the recommended management is presented as determined by the open-label Clinical Investigators.|Within 5 minutes before injection|Full analysis set (only participants for whom information on management was given)||Participants|||Number
797084|NCT00937391|Secondary|Number of Participants With Diagnostic Confidence - Stage 2|The overall diagnostic confidence of the Blinded Readers and the open-label Clinical Investigators was indicated on a 3-point scale: 1=not confident; 2=confident; and 3=very confident. BR=Blinder Reader; CI=Clinical Investigator|Within 5 minutes after injection|Full analysis set||Participants|||Number
797085|NCT00937391|Secondary|Number of Participants With Diagnostic Confidence - Stage 1|The overall diagnostic confidence of the Blinded Readers and the open-label Clinical Investigators was indicated on a 3-point scale: 1=not confident; 2=confident; and 3=very confident. BR=Blinder Reader; CI=Clinical Investigator|Within 5 minutes after injection|Full analysis set||Participants|||Number
797086|NCT00937391|Secondary|Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 2|Those participants for whom the diagnosis changed for at least 1 Blinded Reader from unenhanced to combined images are presented for Stage 2. For completeness, the corresponding data for these participants are presented for the open-label Clinical Investigators. BR=Blinded Reader; CI=Clinical Investigator|Within 5 minutes after injection|Full analysis set||Participants|||Number
797087|NCT00937391|Secondary|Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 1|Those participants for whom the diagnosis changed for at least 1 Blinded Reader from unenhanced to combined images are presented for Stage 1. For completeness, the corresponding data for these participants are presented for the open-label Clinical Investigators. BR=Blinded Reader; CI=Clinical Investigator.|Within 5 minutes after injection|Full analysis set||Participants|||Number
797088|NCT00937391|Secondary|Overall Number of Participants With Change in Diagnosis From Unenhanced to Combined Images - Stage 2|The Blinded Readers and the open-label Clinical Investigators determined the number of participants with a change in diagnosis from unenhanced to combined images. BR = blinded reader; CI = clinical investigator|Within 5 minutes after injection|Full analysis set||Participants|||Number
797089|NCT00937391|Secondary|Overall Number of Participants With Change in Diagnosis From Unenhanced to Combined Images - Stage 1|The Blinded Readers and the open-label Clinical Investigators determined the number of participants with a change in diagnosis from unenhanced to combined images. BR = blinded reader; CI = clinical investigator|Within 5 minutes after injection|Full analysis set||Participants|||Number
797090|NCT00937391|Secondary|Most Frequent Diagnostic Findings With Unenhanced Images - Stage 2|BR = blinded reader; CI = clinical investigator. The Blinded Readers and the open-label Clinical Investigators determined the most frequent diagnostic findings with the unenhanced images|Within 5 minutes after injection|Full analysis set||Participants|||Number
797091|NCT00937391|Secondary|Most Frequent Diagnostic Findings With Unenhanced Images - Stage 1|BR = blinded reader; CI = clinical investigator. The Blinded Readers and the open-label Clinical Investigators determined the most frequent diagnostic findings with the unenhanced images|Within 5 minutes after injection|Full analysis set||Participants|||Number
797092|NCT00937391|Secondary|Number of Participants With Quality of Border Delineation - Stage 2|BR = blinded reader; CI = clinical investigator. The Blinded Readers and the open-label Clinical Investigators determined the quality of border delineation based on a 3-point scale (1=excellent - border completely delineated; 2=fair but adequate - some of the border is delineated; and 3=poor - entire or almost the entire border is not delineated) by image set|Within 5 minutes after injection|Full analysis set||Participants|||Number
798360|NCT00939211|Primary|Forced Expiratory Volume in One Second (FEV1), Peak Effect Within 0 - 24 Hours Post-dose|Maximum FEV1 value|0, 15 min, 30 min, 60 min, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h|||L||Standard Deviation|Mean
797093|NCT00937391|Secondary|Number of Participants With Quality of Border Delineation - Stage 1|BR = blinded reader; CI = clinical investigator. The Blinded Readers and the open-label Clinical Investigators determined the quality of border delineation based on a 3-point scale (1=excellent - border completely delineated; 2=fair but adequate - some of the border is delineated; and 3=poor - entire or almost the entire border is not delineated) by image set|Within 5 minutes after injection|Full analysis set||Participants|||Number
797094|NCT00937391|Secondary|Number of Participants With Quality of Lesion Visualization - Stage 2|BR = blinded reader; CI = clinical investigator. The Blinded Readers and the open-label Clinical Investigators determined the quality of lesion visualization with the unenhanced and the combined image sets based on a 3-point scale (1=excellent - lesion clearly seen and diagnosis possible; 2=fair but adequate - most of lesion seen and diagnosis possible; and 3=poor - lesion barely seen and diagnosis not possible)|Within 5 minutes after injection|Full analysis set||Participants|||Number
797095|NCT00937391|Secondary|Number of Participants With Quality of Lesion Visualization - Stage 1|BR = blinded reader; CI = clinical investigator. The Blinded Readers and the open-label Clinical Investigators determined the quality of lesion visualization with the unenhanced and the combined image sets based on a 3-point scale (1=excellent - lesion clearly seen and diagnosis possible; 2=fair but adequate - most of lesion seen and diagnosis possible; and 3=poor - lesion barely seen and diagnosis not possible)|Within 5 minutes after injection|Full analysis set||Participants|||Number
797096|NCT00937391|Secondary|Number of Participants With Number of Lesions Detected - Stage 2|BR = blinded reader; CI = clinical investigator; unenh. image = unenhanced image; comb. image= combined unenhanced and enhanced image. The Blinded Readers and the open-label Clinical Investigators determined the number of participants with 0, 1, 2, and 3 or more lesions.|Within 5 minutes after injection|Full analysis set||Participants|||Number
797097|NCT00937391|Secondary|Number of Participants With Number of Lesions Detected - Stage 1|BR = blinded reader; CI = clinical investigator; unenh. image = unenhanced image; comb. image= combined unenhanced and enhanced image. The Blinded Readers and the open-label Clinical Investigators determined the number of participants with 0, 1, 2, and 3 or more lesions.|Within 5 minutes after injection|Full analysis set||Participants|||Number
797098|NCT00937391|Primary|PK Analysis - t 1/2|t 1/2 = termination elimination half-life calculated from the area under the drug concentration-time curve from administration to infinity|Samples taken at 20 to 45 min and at 4 to 8 hours post injection; t 1/2 calculated from area under the drug concentration-time curve from administration to infinity|PK population (N=44) was based on the Per Protocol Set (PPS) defined for Stage 1 as all participants (n=18) who received the appropriate dose of Magnevist Injection based on kg body weight (BW) and in Stage 2 as those participants (n=26) who received +/- 10% of the appropriate dose based on kg BW and had values for both PK samples||hour||Full Range|Median
797099|NCT00937391|Primary|PK Analysis - Area Under the Drug Concentration-time Curve (AUC)|AUC = Area under the drug concentration-time curve from administration to infinity|Samples taken 20 to 45 min and 4 to 8 hours post injection. AUC calculated from time of injection to infinity.|PK population (N=44) was based on the Per Protocol Set (PPS) defined for Stage 1 as all participants (n=18) who received the appropriate dose of Magnevist Injection based on kg body weight (BW) and in Stage 2 as those participants (n=26) who received +/- 10% of the appropriate dose based on kg BW and had values for both PK samples||µmol•hour/Liter||Full Range|Median
797100|NCT00937391|Primary|PK Analysis - Volume of Distribution at Steady State (Vss) /Body Weight (BW)|Vss/BW = volume of distribution at steady state normalized by body weight|20 to 45 min and 4 to 8 hours post injection|PK population (N=44) was based on the Per Protocol Set (PPS) defined for Stage 1 as all participants (n=18) who received the appropriate dose of Magnevist Injection based on kg body weight (BW) and in Stage 2 as those participants (n=26) who received +/- 10% of the appropriate dose based on kg BW and had values for both PK samples||Liters/kg||Full Range|Median
797101|NCT00937391|Primary|PK Analysis - Volume of Distribution at Steady State (Vss)|Vss is an estimate of drug distribution independent of the elimination process and is proportional to the amount of drug in the body versus the drug plasma concentration at steady-state.|20 to 45 min and 4 to 8 hours post injection|PK population (N=44) was based on the Per Protocol Set (PPS) defined for Stage 1 as all participants (n=18) who received the appropriate dose of Magnevist Injection based on kg body weight (BW) and in Stage 2 as those participants (n=26) who received +/- 10% of the appropriate dose based on kg BW and had values for both PK samples||Liters||Full Range|Median
797102|NCT00937391|Primary|PK Analysis - Total Clearance (CL)/Body Weight (BW)|CL/BW = total clearance normalized by BW|20 to 45 min and 4 to 8 hours post injection|PK population (N=44) was based on the Per Protocol Set (PPS) defined for Stage 1 as all participants (n=18) who received the appropriate dose of Magnevist Injection based on kg body weight (BW) and in Stage 2 as those participants (n=26) who received +/- 10% of the appropriate dose based on kg BW and had values for both PK samples||Liters/hour/kg||Full Range|Median
797103|NCT00937391|Primary|PK Analysis - Total Clearance (CL)|Total clearance is the fraction of the volume of distribution (Vd) which is completely purified per unit of time and depends also on the plasma half-life of the drug.|20 to 45 min and 4 to 8 hours post injection|PK population (N=44) was based on the Per Protocol Set (PPS) defined for Stage 1 as all participants (n=18) who received the appropriate dose of Magnevist Injection based on kg body weight (BW) and in Stage 2 as those participants (n=26) who received +/- 10% of the appropriate dose based on kg BW and had values for both PK samples||Liters/hour||Full Range|Median
797104|NCT00937391|Primary|Paired-dose Comparison of Number of Participants With Dose Superiority Determined for 4 Lesion Visualization Variables - Blinded Readers|For each participant, the Blinded Reader indicated which dose had better contrast enhancement, better border delineation, clearer internal morphology, and provided more diagnostic information. The dose chosen for 3 or 4 of these variables was the selected dose for that Reader and participant. If each dose was superior on 2 variables, the dose which provided more diagnostic information was selected for that participant. The dose selected for the majority of participants was the dose selected by that Reader; if chosen by 2 or 3 Readers, it was the selected dose.|Within 5 minutes after injection|Primary Analysis Set (the first 5 PPS participants in each age group)||Participants|||Number
797105|NCT00937391|Primary|Dose Determined by Blinded Readers to be Superior for Diagnosis|Dose superiority was a calculation based upon the Blinder Readers' assessment of 4 visualization parameters|Within 5 minutes after injection|Primary analysis set (the first 5 PPS participants in each age group)||Participants|||Number
797106|NCT00937391|Primary|Number of Participants With Diagnostic Adequacy - Open-label Clinical Investigators (Per Protocol Set)|"A clinical judgment by the open-label Clinical Investigators (CIs) as to whether (yes) or not (no) the CI could make a diagnosis from the image."|Within 5 minutes after injection|The first 3 participants of Stage 1 received 2 IV injections of 0.05 mmol/kg body weight (BW), images were obtained after each injection and an assessment made by the CIs as to diagnostic adequacy.||Participants|||Number
797107|NCT00937495|Secondary|Overall Survival|The distribution of survival time will be estimated using the method of Kaplan-Meier.|Time from registration to death due to any cause, assessed up to 2 years|||months||95% Confidence Interval|Median
797108|NCT00937495|Secondary|Progression Free Survival|Progression-free survival is defined as the time from registration to the time of progression or death, whichever comes first. The distribution and median of progression-free survival times will be estimated using the method of Kaplan-Meier.|Up to 2 years|||months||95% Confidence Interval|Median
797109|NCT00937495|Primary|Confirmed Tumor Responses|"The number of confirmed tumor responses is defined as a complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) on two consecutive evaluations at least six weeks apart.
Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest dimension (LD) of target lesions taking as reference the baseline sum LD."|Up to 2 years|||participants|||Number
797110|NCT00937521|Secondary|Number of Subjects With Local and Systemic Reactions Within 7 Days (Day 1-7) After Second rMenB+OMV NZ Vaccination in MenC Group|To assess the safety and tolerability of two doses of rMenB+OMV NZ vaccine (Group VII) given at 12 and 13 months of age to toddlers who previously received three doses of Menjugate as infants.|Day 1 through day 7 at 13 months age.|The analysis was performed on the safety population.||Subjects|||Number
797111|NCT00937521|Secondary|Number of Subjects With Severe Adverse Events and Adverse Events Necessitating a Medical Office or Emergency Room (ER) Visit and/or Resulting in Premature Withdrawal of the Subject From the Study, Throughout the Study Period.|To assess the safety and tolerability of each of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (group I to VI, group VIII) in terms of number of subjects reporting Severe Adverse Events (SAEs) and Adverse Events (AEs) necessitating a medical office or Emergency Room (ER) visit and/or resulting in premature withdrawal of the subject from the study, throughout the study period.|Overall study period.|The analysis was performed on the safety population.||Subjects|||Number
797112|NCT00937521|Secondary|Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination|To assess the safety and tolerability of each of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (group I to VI, group VIII) in terms of number of subjects reporting unsolicited Adverse Events (AEs), serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal (throughout the study period) within 7 days (day 1-7) after each vaccination.|Day 1 through day 7 after each vaccination.|The analysis was performed on the safety population.||Subjects|||Number
797113|NCT00937521|Secondary|Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination|To assess the safety and tolerability of each of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (group I to VI, group VIII) in terms of number of subjects reporting solicited systemic reactions within 7 days (day 1-7) after each vaccination.|Day 1 through day 7 after each vaccination.|The analysis was performed on the safety population.||Subjects|||Number
797114|NCT00937521|Primary|Number of Subjects With Fever ≥ 38.5 °C (Rectal Temperature) Within 3 Days (Day 1-3) After First Vaccination|To assess if any of six different formulations of vaccine groups (Group II to Group VI, Group VIII) reduced the incidence of fever >=38.5C (rectal) occurring within three days (day 1-day3) following first vaccination. The analysis was done on the Safety Population.|Day 1 to day 3 after first vaccination.|The analysis was done on the Safety Population.||Subjects|||Number
797115|NCT00937521|Secondary|Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination|To assess the safety and tolerability of each of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (group I to VI, group VIII) in terms of number of subjects reporting solicited local reactions within 7 days (day 1-7) after each vaccination.|Day 1 through day 7 after each vaccination.|The analysis was performed on the safety population.||Subjects|||Number
797116|NCT00937521|Secondary|Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination|To assess if any of six different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (Group II to VI, Group VIII) reduced the incidence of fever ≥ 38.5ºC (rectal) occurring within 3 days (day 1-3) following second and third vaccination and 7 days (day 1-7) following each vaccination as compared to rMenB+OMV NZ (Group I).|Day 1 through day 7 after second and third vaccination.|As per safety dataset.||Subjects|||Number
797117|NCT00937521|Secondary|Percentage of Subjects With hSBA ≥1:5, First Dose of Meningococcal B Vaccine (One Month After Booster)|To assess the immune response of first dose of meningococcal multi-component recombinant, adsorbed vaccine given at 12 months of age to toddlers who previously received three doses of MenC-CRM197 vaccine as infants (group VII).|1 month after booster|The analysis was done on the Per Protocol population.||Percentage of Subjects||95% Confidence Interval|Number
797118|NCT00937521|Secondary|Geometric Mean Bactericidal Titers, After Primary and Booster Vaccinations (Men B at 12 Months of Age)|To assess the induction of immunological memory of three doses of meningococcal multi-component recombinant, adsorbed vaccine by comparing the serum bactericidal antibodies Geometric Mean Bactericidal Titers (GMTs) response in healthy toddlers administered the fourth dose at 12 months of age to the response in meningococcal B vaccine naive toddlers (Group VII) receiving the first dose of meningococcal multi-component recombinant, adsorbed vaccine at 12 months of age.|At 13 months|The analysis was done on the Per Protocol population.||Titers||95% Confidence Interval|Geometric Mean
797119|NCT00937521|Secondary|Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (One Month-post Fourth Dose)|To assess if any of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (groups I-VI and VIII) induced sufficient immune response when given to healthy toddlers at 12 months of age, as measured by percentage of subjects with SBA titer ≥ 1:5, at 1 month after the fourth vaccination.|1 month after fourth vaccination|The analysis was done on the Per Protocol Booster population.||Percentages of Subjects||95% Confidence Interval|Number
798591|NCT00949078|Primary|Percent Change in Peanut Specific Immunoglobulin E (IgE) From Baseline to After Pn-BHR Response|percentage|change from baseline to up to 6 months|||percentage change Peanut specific IgE||Full Range|Median
797120|NCT00937521|Secondary|Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (Pre-fourth Dose)|To assess the persistence of bactericidal antibodies at 12 months of age after primary vaccination - three doses of one of the seven different formulations of rMenB+OMV NZ or rMenB (no OMV) (Group I-VI and VIII) and rMenB+OMV NZ with paracetamol medication.|12 months (pre-fourth vaccination)|The analysis was done on the Per Protocol Booster population.||Percentages of Subjects||95% Confidence Interval|Number
797121|NCT00937521|Secondary|Geometric Mean Ratios, One Month After Primary and Booster Vaccination (Men B at 12 Months of Age)|To compare the antibody response between meningococcal multi-component recombinant adsorbed vaccine (formulation I) and routine infant vaccine group along with meningococcal multi-component recombinant adsorbed vaccine with prophylactic administration of paracetamol medication as measured by Geometric Mean Ratios (GMRs).|After the third and the booster vaccination.|As per PP population.||Ratios||95% Confidence Interval|Geometric Mean
797122|NCT00937521|Secondary|Geometric Mean Bactericidal Titers,One Month After Primary and Booster Vaccination (Men B at 12 Months of Age)|To compare the antibody response of meningococcal multi-component recombinant, adsorbed vaccine (formulation I vs. formulation VIII) and of routine infant vaccine given with or without prophylactic administration of paracetamol medication in healthy toddlers.|At Baseline (pre-vaccination), at 30 days after the third vaccination, at booster Baseline, at 30 days|As per PP population.||Titers||95% Confidence Interval|Geometric Mean
797123|NCT00937521|Secondary|Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age)|"ToTo assess the immune response of seven different formulations of meningococcal multi-component recombinant, adsorbed vaccine (rMenB+OMV NZ or rMenB (no OMV)) in healthy toddlers as measured by SBA geometric mean titers (GMTs) at:
One month after third vaccination.
One month after booster vaccination (Men B at 12 months of age)."|At baseline (pre-vaccination), 30 days after the third vaccination, at booster Baseline and at booster vaccination (12 months of age)|Per Protocol Primary and Booster populations.||Titers||95% Confidence Interval|Geometric Mean
797124|NCT00937521|Primary|Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination|To assess the immunogenicity of seven different formulations of 4CMenB (groups I-VI and VIII) given to healthy infants at 2,3 and 4 months of age as measured by percentages of subjects with serum bactericidal activity (SBA) titer≥1:5 against 44/76-SL, 5/99 and NZ98/254 reference strains, at 1 month after the third vaccination.. The analysis was done on the Per Protocol Primary Population at one month after third injection.|At baseline (pre-vaccination) and 30 days after the third vaccination.|Analysis as per PP population.||Percentages of Subjects||95% Confidence Interval|Number
797125|NCT00937547|Primary|HPV Type 51|Number of biopsies positive to HPV 51.|6 months|||biopsies|||Number
797126|NCT00937547|Primary|HPV Type 58|Number of biopsies positive to HPV 58.|6 months|||biopsies|||Number
797127|NCT00937547|Primary|HPV Type 45|Number of biopsies positive to HPV 45.|6 months|||biopsies|||Number
797128|NCT00937547|Primary|HPV Type 33|Number of biopsies positive to HPV 33.|6 months|||biopsies|||Number
797129|NCT00937547|Primary|HPV Type 31|Number of biopsies positive to HPV 31.|6 months|||biopsies|||Number
797130|NCT00937547|Primary|HPV Type 18|Number of biopsies positive to HPV 18.|6 months|||biopsies|||Number
797131|NCT00937547|Primary|HPV Type 16|Number of biopsies positive to HPV 16.|6 months|||biopsies|||Number
797132|NCT00937547|Primary|HPV Identification|HPV distribution was identified in CIN2, CIN3 and invasive cervical cancer|6 months|||biopsies|||Number
797133|NCT00937560|Secondary|Adverse Events, Cardiac Events, Lab Parameters, ECOG Performance Status, Vital Signs||Throughout study, laboratory and EOCG assessments every 3 weeks||||||
797134|NCT00937560|Secondary|Biological Progression-free Interval|Biological progression-free interval is defined as the interval from the date of the first administration of any study treatment to the date of the first documented serial elevation of the ovarian cancer mucin CA-125. More precisely, this is defined as the first documented increase in CA-125 levels as follows: (1) CA-125 greater than or equal to 2 times the upper level of normal (ULN) on 2 occasions at least 1 week apart (for patients with CA-125 within normal range pre-treatment) or (2) CA-125 greater than or equal to 2 times the ULN on 2 occasions at least 1 week apart (for patients with elevated CA-125 pre-treatment and initial normalisation of CA-125 on-treatment) or (3) CA-125 greater than or equal to 2 times the nadir value, which is the lowest observed CA-125 value per patient on 2 occasions at least 1 week apart (for patients with elevated CA-125 pre-treatment which never normalised).|Baseline to the data cut-off date of 19 Jul 2012 for analysis of the primary Outcome Measure (follow-up time up to 3 years, 1 month)|Intent-to-treat population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).||Months||95% Confidence Interval|Median
797135|NCT00937560|Secondary|Overall Survival at 1 Year and 2 Years|Reported are the percentage of participants that were alive at 1 year and 2 years after enrolling in the study.|Baseline to Year 2|Intent-to-treat population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).||Percentage of participants||95% Confidence Interval|Number
797136|NCT00937560|Secondary|Duration of Response|Duration of response was defined as the interval between the date of the first documented response by RECIST to the date of first disease progression or death, whichever occurred earlier. Disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of 1 or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Only participants with measurable disease were included in the analysis according to RECIST only. Only participants with a Baseline ovarian cancer mucin CA-125 level ≥ 2 times the upper limit of normal who had a ≥ 50% reduction of CA-125 from Baseline were included in the analysis according to CA-125 level.|Baseline to the data cut-off date of 19 Jul 2012 for analysis of the primary Outcome Measure (follow-up time up to 3 years, 1 month)|Intent-to-treat population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).||Months||95% Confidence Interval|Median
797205|NCT00930722|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) at Week 12|Value at week 12 minus value at baseline.|Baseline and Week 12|FAS included all participants who received at least 1 dose of study medication including those who took it before enrollment. Missing values were imputed by last-observation-carried forward (LOCF).||Millimeters of mercury (mmHg)||Standard Deviation|Mean
797137|NCT00937560|Secondary|Percentage of Participants With an Objective Response|An objective response was defined as either a complete response (CR) or a partial response (PR). Using the Response Evaluation Criteria in Solid Tumors (RECIST), a CR was defined as the disappearance of all target lesions and all non-target lesions, normalization of tumor marker level, and no new lesions and a PR was defined as the disappearance of all target lesions and persistence of ≥ 1 non-target lesions and/or the maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of the longest diameter of target lesions, and no new lesions or unequivocal progression of existing non-target lesions. Only participants with measurable disease were included in the analysis according to RECIST only. Only participants with a Baseline ovarian cancer mucin CA-125 level ≥ 2 times the upper limit of normal who had a ≥ 50% reduction of CA-125 from Baseline were included in the analysis according to CA-125 level.|Baseline to the data cut-off date of 19 Jul 2012 for analysis of the primary Outcome Measure (follow-up time up to 3 years, 1 month)|Intent-to-treat population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).||Percentage of participants||95% Confidence Interval|Number
797138|NCT00937560|Primary|Progression-free Survival|Progression-free survival was defined as the time from the first administration of any study treatment to the first disease progression using Response Evaluation Criteria In Solid Tumors (RECIST) or death from any cause, whichever occurred first.|Baseline to the data cut-off date of 19 Jul 2012 for analysis of the primary Outcome Measure (follow-up time up to 3 years, 1 month)|Intent-to-treat population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).||Months||90% Confidence Interval|Median
797139|NCT00937768|Secondary|Evaluation of Prognostic and Predictive Tissue Based Biomarkers (CTCs, CECs)||||||||
797140|NCT00937768|Secondary|Correlation of Circulating Tumor Cells or Circulating Endothelial Cells Following Study Treatments With Biochemical Progression-free Survival Rate||||||||
797141|NCT00937768|Secondary|Measurements of Serum and Urine Biomarkers, and Comparison Between the Two Arms||||||||
797142|NCT00937768|Secondary|Quality of Life as Assessed by the FACT-P and LASA Tool Within and Between the Two Treatment Arms||Baseline and months 3, 6, 9, 12, 15, 18, 21, and 24||||||
797143|NCT00937768|Secondary|Toxicity as Per NCI CTCAE Version 3||||||||
797144|NCT00937768|Secondary|Biochemical Progression-free Survival (BPFS), Overall Survival (OS), and Prostate Cancer Specific Survival (PCS)||||||||
797145|NCT00937768|Primary|Biochemical Progression-free Survival Rate||2 years|No participants reached the 2 years follow up due to the early termination of the trial.|||||
797146|NCT00937794|Primary|Number of Participants With a Score of at Least 90 on The General Conceptual Ability (GCA) Sub-Scale of The Differential Ability Scale (DAS)|The GCA sub-scale of the DAS, Second Edition (DAS-II) was used to obtain a general measure of cognitive ability.The maximum score is 120, with a higher score indicating greater cognitive ability. A score of 100 is considered an average score.|1 month|All enrolled patients, defined as patients who met the inclusion criteria and consented to participate in the study.||participants|||Number
797147|NCT00937794|Primary|Number of Participants Who Were Screened For The Follow-On Study With an Investigational Agent|"Standardized tests were used to identify patients who were receiving treatment with Elaprase, had cognitive impairment, and were suitable to participate in the follow-on clinical study (HGT-HIT-045). Assessments included:
Cognition: The Differential Ability Scale, Second Edition (DAS-II) or the Bayley Scales of Infant Development, Third Edition (BSID-III);
Adaptive Behavior: The Scale of Independent Behavior-Revised (SIB-R);
Executive Function: The Behavior Rating Inventory of Executive Function-Preschool version (BRIEF-P) for children or the Behavior Rating Inventory of Executive Function (BRIEF) for children less than or ≥6 years of age, respectively;
Motor: The Peabody Developmental Motor Scales-2 (PDMS-2) or the Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2) for children less than or ≥6 years of age, respectively."|1 month|All enrolled patients, defined as patients who met the inclusion criteria and consented to participate in the study.||participants|||Number
797148|NCT00937833|Primary|Number of Continent Patients Post Prostatectomy||1 Month|||participants|||Number
797149|NCT00929864|Secondary|Proportion of Participants With Induction of Autoantibodies During the 12 Months and 24 Months Periods - ITT Population|The induction of autoantibodies was defined as participant’s antinuclear antibodies (ANA) or anti-double stranded deoxyribonucleic acid (dsDNA) converting from a negative status at baseline to a positive status at a post-baseline measurement time point (Day 365 or Day 729). Proportion (%) = n/m, where n=number of participants with positive ANA or dsDNA at a time point and m=number of participants who had negative ANA or dsDNA at baseline. Blood samples were first tested for ANA by indirect fluorescent assay using HEp-2 Cell Line Substrate, and when positive, samples were further tested for anti-dsDNA by indirect fluorescent assay using Crithidia Luciliae Substrate.|Day 1 to Day 729|ITT population was defined as all participants randomized into the study who received at least one dose of study drug; number analyzed was ITT participants with data at each time point and who had negative ANA or dsDNA at baseline (m)||Percentage of participants||95% Confidence Interval|Number
797150|NCT00929864|Secondary|Incidence Rate of Serious Adverse Events (SAEs), Serious Infections, Pre-specified Opportunistic Infections, and Discontinuation for Any Cause at 24 Months of Treatment - ITT Population|Pre-specified opportunistic infections include: pneumonia, tuberculosis, herpes zoster, combined opportunistic infections, and all hospitalized infections. Incidence Rate: incidence/100 person-years: numerator was number of unique events within this period (up to 56 days post the last dose of the 24 Months period); denominator was overall total exposure (person-years) within this period, which was calculated as the sum over all participants of exposure (in days) divided by 365.25. The resulting incidence rate was multiplied by 100 to express the rate per 100 person-years. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE is a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|Day 1 to Day 729|The intent to treat (ITT) analysis population was defined as all subjects randomized into the study who received at least one dose of study drug. Poisson distribution was used to construct the 95% CIs.||incidence/100 person-years||95% Confidence Interval|Number
799404|NCT00947310|Primary|Inappropriate ICD Therapy|First occurance of inappropriate therapy (either anti-tachycardia pacing or shock)|Average of 1.4 years follow-up|||participants|||Number
797151|NCT00929864|Secondary|Incidence Rate of Serious Adverse Events (SAEs), Serious Infections, Pre-specified Opportunistic Infections, and Discontinuation for Any Cause at 12 Months of Treatment - ITT Population|Pre-specified opportunistic infections include: pneumonia, tuberculosis, herpes zoster, combined opportunistic infections, all hospitalized infections. Incidence Rate: incidence/100 person-years: numerator was number of unique events within this period (up to 56 days post-last dose of first 12 months or start of first dose of second 12 months); denominator was overall total exposure (person-years) within this period, calculated as sum over all participants of exposure (in days) divided by 365.25. The resulting incidence rate was multiplied by 100 to express rate per 100 person-years. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE is a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|Day 1 to Day 365|The intent to treat (ITT) analysis population was defined as all subjects randomized into the study who received at least one dose of study drug. Poisson distribution was used to construct the 95% CIs.||incidence/100 person-years||95% Confidence Interval|Number
797152|NCT00929864|Secondary|Proportion of Participants Without Radiographic Progression in Total Score Less Than or Equal to the Smallest Detectable Change (SDC) From Baseline to Months 12 and 24 Using Modified Van Der Heijde Total Sharp Score (mSvdHS) - ITT Population|Plain radiographs of hands and feet taken at baseline (BL), Day 365, and Day 729. BL and Day 365 radiographs were re-read concurrent with Day 729 films by readers blinded to sequence and treatment (a second pre-specified reading campaign). SDC defined as amount of change for which anything smaller could not be reliably distinguished from random error in measurement of simultaneously read films. Non-progression defined: change from BL (Day 1, prior to dosing) in total score less than, equal to (<=) SDC(2.2). Proportion n/m (%)=number meeting criteria (n); number analyzed (m). SDC calculated as SD/sqrt(2)*1.96/sqrt(2)with standard deviation (SD) of paired differences of change from BL in total score between 2 readers; squared root(sqrt). mSvdHS=summary of erosion severity in 32 hand and 12 foot joints. Hand joints scored 0 to 5; foot joints 0 to 10 with 0=no erosion and higher numbers indicating greater erosion severity. BL: radiographic data within 14 days or less of first dose.|Baseline to Day 729|ITT population: all subjects randomized into the study who received at least one dose of study drug. Number analyzed: m=number of ITT participants with both BL and post-BL total score: Day 365: m=295, 297;Day 729 m=257 and 260, in abatacept and adalimumab arms, respectively. n=number without progression. CI based on normal approximation.||percentage of participants||95% Confidence Interval|Number
797153|NCT00929864|Secondary|Incidence Rate of Local Injection Site Reactions (Pre-specified) Reported During 24 Month Period - ITT Population|Incidence Rate: (incidence/100 person-years) = number of participants with event * 100 /exposure (person-years) Exposure (person-years) = the sum over all participants of the exposure per participant in the 24 months (censored at the time of first occurrence of AE) expressed in days, divided by 365.25. The 24 Month Period includes data up to 56 days post the last dose in the 24 month period. Poisson distribution used to construct the 95% CIs.|Day 1 to Day 729|ITT population: all participants randomized into the study who received at least one dose of study drug. Participants with a pre-specified local injection site event at 24 Months: 13, 34, in abatacept and adalimumab arms, respectively. 24 Month Exposure=579.21, 532.99, respectively.||incidence/100 person years||95% Confidence Interval|Number
797154|NCT00929864|Secondary|Proportion of Participants With Local Injection Site Reactions Adverse Events (Pre-specified) Reported During 12 Month Period - ITT Population|n=number of participants with a pre-specified local injection site reaction event, N=number of participants at risk. Proportion (%) = n/N. 12 Months includes data up to 56 days post last dose of the first 12 months Period or start of the first dose of second 12 months period.|Day 1 to 12 Months|The ITT analysis population was defined as all participants randomized into the study who received at least one dose of study drug. n/N = 12/318, 30/328 in abatacept and adalimumab, respectively. CI based on normal approximation.||percentage of participants||95% Confidence Interval|Number
797155|NCT00929864|Primary|The Proportion of Participants Meeting the American College of Rheumatology (ACR) Criteria of 20% Improvement (ACR20) After 12 Months of Treatment - Intent to Treat Population|Proportion(%)=number of participants meeting criteria (n) divided by number of participants who received drug (N). The ACR score indicates degree of improvement in a patient's rheumatoid arthritis (RA), based on guidelines set forth by the ACR and represents a percentage. To qualify a ACR20 score, patient must have >=20% fewer tender joints and >=20% fewer swollen joints and show 20% improvement from baseline in at least 3 of: patient overall assessment of his/her RA, physician global assessment of the patient’s RA, patient self-assessment of pain, patient self-assessment of physical functioning, and results of an erythrocyte sedimentation rate or C-reactive protein (CRP) test (to assess inflammation). Baseline was Day 1. Randomization was stratified using screening Disease Activity Score-28 (DAS28) CRP, a composite of 4 variables: number of tender joints/28, number of swollen joints/28, CRP in mg/L and participant assessment of disease activity with visual analogue scale.|Day 1 to Day 365|The intent to treat (ITT) analysis population was defined as all participants randomized into the study who received at least one dose of study drug. n/N = 206/318 and 208/328 in the abatacept and adalimumab arms, respectively.||percentage of participants||95% Confidence Interval|Number
797156|NCT00929981|Secondary|Change From Baseline in Investigator-rated Total Signs and Symptoms of CD Score at First, Second, Third and Final Follow-up Visits|Investigator-rated total signs and symptoms score of CD included pruritus, erythema, induration, vesiculation, edema or other specific sign or symptom rated on a 5 point scale of 0 – 4 (0=none, 1=mild, 2=moderate, 3=severe, 4=extreme) with a total score of 0 - 20 (lower score was preferred).|Baseline,First Follow-up(between Day 6-10 of start of treatment),Second(Day 5-28),Third(between Day 6-10 after EOT),Final(between Day 25-35 after EOT)|FAS population included all participants who received at least 1 dose of study medication.||Units on a scale||Standard Deviation|Mean
797157|NCT00929981|Secondary|Change From Baseline in Participant-rated Pruritus Score at First, Second, Third and Final Follow-up Visits|Participant-rated pruritus score of lesions rated the severity of pruritus suffered in the past 24 hours on an 11-point NRS where 0 = no pruritus and 10 = most severe possible pruritus.|Baseline,First Follow-up(between Day 6-10 of start of treatment),Second(Day 5-28),Third(between Day 6-10 after EOT),Final(between Day 25-35 after EOT)|FAS population included all participants who received at least 1 dose of study medication.||Units on a scale||Standard Deviation|Mean
797158|NCT00929981|Secondary|Change From Baseline in Participant-rated Clinical Severity Score of Lesions at First, Second, Third and Final Follow-up Visits|Participant-rated clinical severity score of lesions rated the severity of all symptoms in the past 24 hours on an 11-point Numerical Rating Scale (NRS) where 0 = No lesions and 10 = Most severe possible lesions.|Baseline,First Follow-up(between Day 6-10 of start of treatment),Second(Day 5-28),Third(between Day 6-10 after EOT),Final(between Day 25-35 after EOT)|FAS population included all participants who received at least 1 dose of study medication.||Units on a scale||Standard Deviation|Mean
797159|NCT00929981|Secondary|Treatment Status (Success/Failure) of CD at the Final Follow-up Visit|The signs and symptoms of CD were rated on PGA 5-point scale (range, 0 – 4 scale):0 - no clinically relevant reaction; 1- macular erythema with induration; 2 - weak (non-vesicular) reaction with erythema, infiltration, and possible papules; 3 - strong (edematous or vesicular) reaction; 4 - extreme (spreading, bullous, ulcerative) reaction. “Success” was defined as a score of 0 or 1 and “failure” was defined as a score of 2, 3, or 4.|Final follow-up visit (between Day 25 to 35 after EOT)|FAS population included all participants who received at least 1 dose of study medication.||Percentage of Participants||95% Confidence Interval|Number
797160|NCT00929981|Secondary|Treatment Status (Success/Failure) of CD at the Third Follow-up Visit|The signs and symptoms of CD were rated on PGA 5-point scale (range, 0 – 4 scale):0 - no clinically relevant reaction; 1- macular erythema with induration; 2 - weak (non-vesicular) reaction with erythema, infiltration, and possible papules; 3 - strong (edematous or vesicular) reaction; 4 - extreme (spreading, bullous, ulcerative) reaction. “Success” was defined as a score of 0 or 1 and “failure” was defined as a score of 2, 3, or 4.|Third follow-up visit (between Day 6 to 10 after EOT)|FAS population included all participants who received at least 1 dose of study medication.||Percentage of Participants||95% Confidence Interval|Number
797161|NCT00929981|Secondary|Treatment Status (Success/Failure) of CD at the First Follow-up Visit|The signs and symptoms of CD were rated on PGA 5-point scale (range, 0 – 4 scale):0 - no clinically relevant reaction; 1- macular erythema with induration; 2 - weak (non-vesicular) reaction with erythema, infiltration, and possible papules; 3 - strong (edematous or vesicular) reaction; 4 - extreme (spreading, bullous, ulcerative) reaction. “Success” was defined as a score of 0 or 1 and “failure” was defined as a score of 2, 3, or 4.|First follow-up visit (between Day 6 to 10 after start of treatment)|FAS population included all participants who received at least 1 dose of study medication.||Percentage of Participants||95% Confidence Interval|Number
797162|NCT00929981|Primary|Treatment Status (Success/Failure) of Contact Dermatitis (CD) at the Second Follow-up Visit|The signs and symptoms of CD were rated on Physician’s Global Assessment (PGA) 5-point scale (range, 0 – 4 scale):0 - no clinically relevant reaction; 1- macular erythema with induration; 2 - weak (non-vesicular) reaction with erythema, infiltration, and possible papules; 3 - strong (edematous or vesicular) reaction; 4 - extreme (spreading, bullous, ulcerative) reaction. “Success” was defined as a score of 0 or 1 and “failure” was defined as a score of 2, 3, or 4.|Second follow-up visit (Day 5-28)|Full analysis set (FAS) population included all participants who received at least 1 dose of study medication.||Percentage of Participants||95% Confidence Interval|Number
797163|NCT00930176|Primary|FX:C Half-life|Value given is the mean of 31 results: 16 for Baseline Visit + 15 for Repeat PK assessment|At Baseline and at 6 months post-Baseline|||hours||Geometric Coefficient of Variation|Geometric Mean
797164|NCT00930176|Primary|FX:C Incremental Recovery|"Incremental recovery is defined as the peak rise in plasma FX levels (IU/dL), as measured at 15, 30 and 60 minutes post-dose, divided by the dose (IU/kg).
Value given is the mean of 31 results: 16 for Baseline Visit + 15 for Repeat PK assessment"|At Baseline (during first 60 minutes post-dose) and at 6 months post-Baseline (during first 60 minutes post-dose)|||IU/dL per IU/kg||Geometric Coefficient of Variation|Geometric Mean
797165|NCT00930293|Secondary|Weeks to Depression Remission|"Kaplan-Meier survival analyses to determine time to depression remission (defined as average HRSD-17 score < or = 7 for three consecutive weeks).
Analyses run with the full intent to treat sample (censoring patients who dropped out at time of termination)"|Measured at baseline and weekly for up to 20 weeks of treatment|||weeks||Standard Error|Mean
797166|NCT00930293|Primary|Number of Participants Meeting Depression Remission Criteria|Depression remission defined as 3 consecutive weeks of HRSD-17 scores that on average, < or = 7|Measured at baseline and weekly for up to 20 weeks of acute treatment|||participants|||Number
797167|NCT00930553|Secondary|Change From Baseline in European Quality of Life -5 Dimension (EQ-5D) Visual Analog Scale Score Before and After Alemtuzumab Treatment: 2 Year Comparison|EQ-5D is a standardized instrument for measuring health status consisting of EQ-5D descriptive system and VAS. The EQ-5D VAS range is from 0-100, higher scores indicate a better health state and a positive change indicates improvement. The IFNB-1a/Alemtuzumab switch from CAMMS323 or CAMMS324 to CAMMS03409 pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting group.|Baseline (Year 0 of initial studies) up to Year 4|Subset of FAS who received IFNB-1a in CAMMS323 or CAMMS324 and who were treated with alemtuzumab in CAMMS03409.||units on a scale||95% Confidence Interval|Mean
797168|NCT00930553|Secondary|Change From Baseline in European Quality of Life -5 Dimension (EQ-5D) Visual Analog Scale Score at Year 3, 4, 5 and 6|EQ-5D is a standardized instrument for measuring health status consisting of EQ-5D descriptive system and Visual Analogue Scale (VAS). The EQ-5D VAS range is from 0-100, higher scores indicate a better health state and a positive change indicates improvement.|"Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for “Alemtuzumab Treatment CAMMS323 Extension group and “Alemtuzumab Treatment CAMMS324 Extension” group, respectively), Year 3, 4, 5 and 6"|Subset of full analysis set (FAS - defined as all participants randomized in CAMMS223, CAMMS323, and CAMMS324 and who received at least 1 dose of study drug) included participants who had received at least 1 dose of alemtuzumab in CAMMS323 and CAMMS324. Number of participants analyzed = participants with available data for this outcome measure.||units on a scale||95% Confidence Interval|Mean
797201|NCT00930722|Secondary|Change From Pre-treatment in SBP at Week 0|Value at Week 0 minus value at pre-treatment. Pre-treatment BP was the last BP recorded before taking study medication from retrospective data. If no such value was available, the earliest retrospective BP value from medical records was considered.|Pre-treatment and Week 0|FAS included all participants who received at least 1 dose of study medication including those who took it before enrolment. Missing values were imputed by LOCF.||mmHg||Standard Deviation|Mean
799405|NCT00947310|Secondary|Syncope|First episode of syncope|Average of 1.4 years follow-up|||participants|||Number
797169|NCT00930553|Secondary|Change From Baseline in Self-reported Quality of Life as Assessed by Functional Assessment of Multiple Sclerosis (FAMS) Score Before and After Alemtuzumab Treatment: 2 Year Comparison|FAMS is a widely accepted, MS-specific, quality of life questionnaire. It comprised of 58 items on 7 subscales: mobility (7 items); symptoms (7 items); emotional well-being (7 items); general contentment (7 items); thinking and fatigue (9 items); family/social well-being (7 items); and additional concerns (14 items, these are not scored). Participants provided their response based on the recall of past week. Each item was rated on a 5-point scale ranges from 0 (poor) to 4 (best), where higher scores indicated higher/better quality of life. Scores from 44 calculable items were summed to provide FAMS total score. FAMS total score ranges from 0 (poor) to 176 (best), where higher scores indicated higher/better quality of life. The IFNB-1a/Alemtuzumab switch from CAMMS323 or CAMMS324 to CAMMS03409 pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting group.|Baseline (Year 0 of initial studies) up to Year 4|Subset of FAS who received IFNB-1a in CAMMS323 or CAMMS324 and who were treated with alemtuzumab in CAMMS03409.||units on a scale||95% Confidence Interval|Mean
797170|NCT00930553|Secondary|Change From Baseline in Self-reported Quality of Life as Assessed by Functional Assessment of Multiple Sclerosis (FAMS) Score at Year 3, 4, 5 and 6|FAMS is a widely accepted, MS-specific, quality of life questionnaire. It comprised of 58 items on 7 subscales: mobility (7 items); symptoms (7 items); emotional well-being (7 items); general contentment (7 items); thinking and fatigue (9 items); family/social well-being (7 items); and additional concerns (14 items, these are not scored). Participants provided their response based on the recall of past week. Each item was rated on a 5-point scale ranges from 0 (poor) to 4 (best), where higher scores indicated higher/better quality of life. Scores from 44 calculable items were summed to provide FAMS total score. FAMS total score ranges from 0 (poor) to 176 (best), where higher scores indicated higher/better quality of life.|"Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for “Alemtuzumab Treatment CAMMS323 Extension group and “Alemtuzumab Treatment CAMMS324 Extension” group, respectively), Year 3, 4, 5, 6"|Subset of full analysis set (FAS - defined as all participants randomized in CAMMS223, CAMMS323, and CAMMS324 and who received at least 1 dose of study drug) included participants who had received at least 1 dose of alemtuzumab in CAMMS323 and CAMMS324. Number of participants analyzed = participants with available data for this outcome measure.||units on a scale||95% Confidence Interval|Mean
797171|NCT00930553|Secondary|Change From Baseline in Mental Component Score (MCS) of Short Form-36 (SF-36) Before and After Alemtuzumab Treatment: 2 Year Comparison|"SF-36 is a participant reported standardized survey designed to assess generic health related quality of life. It consisted of 36 items evaluating 8 aspects of functional health and well-being: 1) physical functioning, 2) role physical, 3) bodily pain, 4) general health, 5) vitality, 6) social functioning, 7) role emotional and 8) mental health. The score range for each of the 8 health aspects was from 0 (poor health) to 100 (better health), higher scores indicating good health condition. Scores of last four health aspects (5 - 8) were aggregated to derive the MCS ranging from 0 (worst) to 100 (best), where higher scores indicated good health condition. The IFNB-1a/Alemtuzumab switch from CAMMS323 or CAMMS324 to CAMMS03409 pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting group. Baseline was defined as Year 0 of CAMMS323 and Year 0 of CAMMS324 for “CAMMS323” and “CAMMS324 participants, respectively."|Baseline (Year 0 of initial studies) up to Year 4|Subset of FAS who received IFNB-1a in CAMMS323 or CAMMS324 and who were treated with alemtuzumab in CAMMS03409.||units on a scale||95% Confidence Interval|Mean
797172|NCT00930553|Secondary|Change From Baseline in Mental Component Score (MCS) of Short Form-36 (SF-36) at Year 3, 4, 5, and 6|SF-36 is a participant reported standardized survey designed to assess generic health related quality of life. It consisted of 36 items evaluating 8 aspects of functional health and well-being: 1) physical functioning, 2) role physical, 3) bodily pain, 4) general health, 5) vitality, 6) social functioning, 7) role emotional and 8) mental health. The score range for each of the 8 health aspects was from 0 (poor health) to 100 (better health), higher scores indicating good health condition. Scores of last four health aspects (5 - 8) were aggregated to derive the MCS ranging from 0 (worst) to 100 (best), where higher scores indicated good health condition.|"Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for “Alemtuzumab Treatment CAMMS323 Extension group and “Alemtuzumab Treatment CAMMS324 Extension” group, respectively), Year 3, 4, 5 and 6"|Subset of full analysis set (FAS - defined as all participants randomized in CAMMS223, CAMMS323, and CAMMS324 and who received at least 1 dose of study drug) included participants who had received at least 1 dose of alemtuzumab in CAMMS323 and CAMMS324. Number of participants analyzed = participants with available data for this outcome measure.||units on a scale||95% Confidence Interval|Mean
797173|NCT00930553|Secondary|Change From Baseline in Physical Component Score (PCS) of Short Form-36 (SF-36) Health Survey Before and After Alemtuzumab Treatment: 2 Year Comparison|"SF-36 is a participant reported standardized survey designed to assess generic health related quality of life. It consisted of 36 items evaluating 8 aspects of functional health and well-being: 1) physical functioning, 2) role physical, 3) bodily pain, 4) general health, 5) vitality, 6) social functioning, 7) role emotional and 8) mental health. The score range for each of the 8 health aspects was from 0 (poor health) to 100 (better health), higher scores indicating good health condition. Scores of first four health aspects (1 - 4) were aggregated to derive the PCS ranging from 0 (worst) to 100 (best), where higher scores indicated good health condition. The IFNB-1a/Alemtuzumab switch from CAMMS323 or CAMMS324 to CAMMS03409 pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting group. Baseline was defined as Year 0 of CAMMS323 and Year 0 of CAMMS324 for “CAMMS323” and “CAMMS324 participants, respectively."|Baseline (Year 0 of initial studies) up to Year 4|Subset of FAS who received IFNB-1a in CAMMS323 or CAMMS324 and who were treated with alemtuzumab in CAMMS03409.||units on a scale||95% Confidence Interval|Mean
797202|NCT00930722|Secondary|Change From Baseline in DBP at Week 52|Value at week 52 minus value at baseline.|Baseline and Week 52|The FAS-FU included the subset of participants who had at least 1 additional BP measurement. This analysis was not conducted because only 2 participants were eligible for inclusion in the FAS-FU.||mmHg||Standard Deviation|Mean
797203|NCT00930722|Secondary|Change From Baseline in SBP at Week 52|Value at week 52 minus value at baseline.|Baseline and Week 52|The “full analysis set – follow up” (FAS-FU) included the subset of participants who had at least 1 additional BP measurement. This analysis was not conducted because only 2 participants were eligible for inclusion in the FAS-FU.||mmHg||Standard Deviation|Mean
799406|NCT00947310|Secondary|All-cause Mortality||Average 1.4 years of follow-up|||participants|||Number
797174|NCT00930553|Secondary|Change From Baseline in Physical Component Score (PCS) of Short Form-36 (SF-36) Health Survey at Year 3, 4, 5 and 6|SF-36 is a participant reported standardized survey designed to assess generic health related quality of life. It consisted of 36 items evaluating 8 aspects of functional health and well-being: 1) physical functioning, 2) role physical, 3) bodily pain, 4) general health, 5) vitality, 6) social functioning, 7) role emotional and 8) mental health. The score range for each of the 8 health aspects was from 0 (poor health) to 100 (better health), higher scores indicating good health condition. Scores of first four health aspects (1 - 4) were aggregated to derive the PCS ranging from 0 (worst) to 100 (best), where higher scores indicated good health condition.|Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for “alemtuzumab treatment CAMMS323 extension group”, “alemtuzumab Treatment CAMMS324 Extension” group, respectively),Year 3, 4, 5 and 6|Subset of full analysis set (FAS - defined as all participants randomized in CAMMS223, CAMMS323, and CAMMS324 and who received at least 1 dose of study drug) included participants who had received at least 1 dose of alemtuzumab in CAMMS323 and CAMMS324. Number of participants analyzed = participants with available data for this outcome measure.||units on a scale||95% Confidence Interval|Mean
797175|NCT00930553|Secondary|Percentage of Relapse Free Participants|Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination, attributable to MS that last for at least 48 hours, present at normal body temperature, and that were preceded by at least 30 days of clinical stability.|Year 3, 4, 5 and 6|Subset of full analysis set (FAS - defined as all participants randomized in CAMMS223, CAMMS323, and CAMMS324 and who received at least 1 dose of study drug) included participants who had received at least 1 dose of alemtuzumab in CAMMS323 and CAMMS324. Number of participants analyzed = participants with available data for this outcome measure.||percentage of participants|||Number
797176|NCT00930553|Secondary|Percent Change From Baseline in Brain Parenchymal Fractions (BPF) at Year 3, 4, 5 and 6|Brain parenchymal fraction (calculated as the ratio of brain parenchymal volume to total intradural volume), is a sensitive indicator of brain atrophy.|"Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for “Alemtuzumab Treatment CAMMS323 Extension group and “Alemtuzumab Treatment CAMMS324 Extension” group, respectively), Year 3, 4, 5 and 6"|Subset of full analysis set (FAS - defined as all participants randomized in CAMMS223, CAMMS323, and CAMMS324 and who received at least 1 dose of study drug) included participants who had received at least 1 dose of alemtuzumab in CAMMS323 and CAMMS324. Number of participants analyzed = participants with available data for this outcome measure.||percent change||Standard Deviation|Mean
797177|NCT00930553|Secondary|Percentage of Participants Without New Gadolinium-enhancing MRI Lesion Activity|Analysis of new gadolinium-enhancing lesions that appear on MRI scans performed annually. Baseline was the prior annual visit.|Year 3, 4, 5 and 6|Subset of full analysis set (FAS - defined as all participants randomized in CAMMS223, CAMMS323, and CAMMS324 and who received at least 1 dose of study drug) included participants who had received at least 1 dose of alemtuzumab in CAMMS323 and CAMMS324. Number of participants analyzed = participants with available data for this outcome measure.||percentage of participants|||Number
797178|NCT00930553|Secondary|Percentage Change From Baseline in MRI-T2-Hypertense Lesion Volumes at Year 3, 4, 5, 6|Lesion volume was quantitatively assessed by hyperintensity on T2-weighted MRI scans.|"Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for “Alemtuzumab Treatment CAMMS323 Extension group and “Alemtuzumab Treatment CAMMS324 Extension” group, respectively), Year 3, 4, 5, 6"|Subset of full analysis set (FAS - defined as all participants randomized in CAMMS223, CAMMS323, and CAMMS324 and who received at least 1 dose of study drug) included participants who had received at least 1 dose of alemtuzumab in CAMMS323 and CAMMS324. Number of participants analyzed = participants with available data for this outcome measure.||percent change||Standard Deviation|Mean
797179|NCT00930553|Secondary|Percentage of Participants Without New or Enlarging MRI-T2-Hypertense Lesion Activity Before and After Alemtuzumab Retreatment|Analysis of new or enlarging lesions that appear hyperintense on T2-weighted MRI scans performed annually. Retreatment baseline was the annual visit prior to the retreatment start date.|Retreatment Baseline, Year 1, 2 and 3 after retreatment|Subset of FAS included participants who had received alemtuzumab in CAMMS323 or CAMMS324 and received an additional course of alemtuzumab in this extension study.||percentage of participants|||Number
797180|NCT00930553|Secondary|Percentage of Participants Without New or Enlarging MRI-T2-Hypertense Lesion Activity Before and After Alemtuzumab Treatment|Analysis of new or enlarging lesions that appear hyperintense on T2-weighted MRI scans performed annually. The IFNB-1a/Alemtuzumab switch from CAMMS323 or CAMMS324 to CAMMS03409 pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting group.|Baseline (Year 0 of initial studies) up to Year 4|Subset of FAS who received IFNB-1a in CAMMS323 or CAMMS324 and who were treated with alemtuzumab in CAMMS03409.||percentage of participants|||Number
797181|NCT00930553|Secondary|Percentage of Participants Without New or Enlarging Magnetic Resonance Imaging (MRI)-T2-Hypertense Lesion Activity|Analysis of new or enlarging lesions that appear hyperintense on T2-weighted MRI scans performed annually.|Year 3, 4, 5 and 6|Subset of full analysis set (FAS - defined as all participants randomized in CAMMS223, CAMMS323, and CAMMS324 and who received at least 1 dose of study drug) included participants who had received at least 1 dose of alemtuzumab in CAMMS323 and CAMMS324. Number of participants analyzed = participants with available data for this outcome measure.||percentage of participants|||Number
797182|NCT00930553|Secondary|Change From Retreatment Baseline in EDSS Score After Alemtuzumab Retreatment|EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses the 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), where higher scores indicate worse neurological function. Change was calculated by subtracting retreatment baseline (annual visit prior to the retreatment start date) value from EDSS scores at specified time points.|Retreatment baseline, Year 1, 2 and 3 after retreatment baseline|Subset of FAS included participants who had received alemtuzumab in CAMMS323 or CAMMS324 and received an additional course of alemtuzumab in this extension study.||units on a scale||Standard Deviation|Mean
797204|NCT00930722|Secondary|Change From Baseline in Diastolic Blood Pressure (DBP) at Week 12|Value at week 12 minus value at baseline.|Baseline and Week 12|FAS included all participants who received at least 1 dose of study medication including those who took it before enrollment. Missing values were imputed by LOCF.||mmHg||Standard Deviation|Mean
797183|NCT00930553|Secondary|Change From Initial Study Baseline in EDSS Score Before and After Alemtuzumab Treatment: 2 Year Comparison|EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses the 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), where higher scores indicate worse neurological function. Change was calculated by subtracting baseline (Month 0 of the study CAMMS323 or CAMMS324 for pre alemtuzumab period or CAMMS03409 baseline for post alemtuzumab period) value, from EDSS scores at specified time points. The IFNB-1a/Alemtuzumab switch pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting groups. Baseline was defined as Year 0 of CAMMS323 and Year 0 of CAMMS324 for “CAMMS323 participants” and “CAMMS324 participants” respectively.|Baseline (Year 0 of initial studies) up to Year 4|Subset of FAS who received IFNB-1a in CAMMS323 or CAMMS324 and who were treated with alemtuzumab in CAMMS03409.||units on a scale||95% Confidence Interval|Mean
797184|NCT00930553|Secondary|Change From Initial Study Baseline in EDSS Score at Year 3, 4, 5 and 6|EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses the 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), where higher scores indicate worse neurological function. Change was calculated by subtracting baseline (Month 0 of the study CAMMS323 [NCT00530348] or CAMMS324 [NCT00548405]) value from EDSS scores at specified time points.|"Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for “Alemtuzumab Treatment CAMMS323 Extension group and “Alemtuzumab Treatment CAMMS324 Extension” group, respectively), Year 3, 4, 5, 6"|Subset of full analysis set (FAS - defined as all participants randomized in CAMMS223, CAMMS323, and CAMMS324 and who received at least 1 dose of study drug) included participants who had received at least 1 dose of alemtuzumab in CAMMS323 and CAMMS324. Number of participants analyzed = participants with available data for this outcome measure.||units on a scale||95% Confidence Interval|Mean
797185|NCT00930553|Secondary|Number of Participants With Sustained Reduction in Disability (SRD) Assessed by EDSS (After Alemtuzumab Treatment) at Year 2 of the Extension Study|SRD was defined as a >=1 point decrease in EDSS score lasting >=6 months. SRD is only applicable to participants with a baseline EDSS score of ≥2.0. EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), where higher scores indicate worse neurological function. Number of participants with SRD at Year 2 of CAMMS03409 was estimated using Kaplan-Meier method and reported in this outcome measure. The IFNB-1a/Alemtuzumab switch from CAMMS323 or CAMMS324 to CAMMS03409 pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting group.|Extension study (CAMMS03409) baseline up to Extension Year 2|Subset of FAS who received IFNB-1a in CAMMS323 or CAMMS324 and who were treated with alemtuzumab in CAMMS03409. Number of participants analyzed = participants with available data for this outcome measure.||Participants|||Count of Participants
797186|NCT00930553|Secondary|Number of Participants With Sustained Reduction in Disability (SRD) Assessed by EDSS at Year 6|SRD was defined as a ≥1 point decrease in EDSS score lasting >= 6 months. SRD is only applicable to participants with a baseline EDSS score of >= 2.0. EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), where higher scores indicate worse neurological function. Number of participants with SRD at Year 6 was estimated using Kaplan-Meier method and reported in this outcome measure.|Baseline (Year 0) up to Year 6|Subset of full analysis set (FAS - defined as all participants randomized in CAMMS223, CAMMS323, and CAMMS324 and who received at least 1 dose of study drug) included participants who had received at least 1 dose of alemtuzumab in CAMMS323 and CAMMS324. Number of participants analyzed = participants with available data for this outcome measure.||Participants|||Count of Participants
797187|NCT00930553|Primary|Number of Participants With Sustained Accumulation of Disability (SAD) Before and After Alemtuzumab Treatment: 2 Year Comparison|SAD: defined as an increase of at least 1.5 points in EDSS score for participants with prior study baseline score of 0 and increase of at least 1.0 point for participants with a prior study baseline score of 1.0 or more; and the increase persisted over a 6-month consecutive period. EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) and ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), higher scores indicating worse neurological function. Number of participants with SAD over 2 years before and 2 years after alemtuzumab treatment were estimated by Kaplan-Meier method and reported in this outcome measure. The IFNB-1a/Alemtuzumab switch pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting group.|Baseline (Year 0 of initial studies) up to Year 4|Subset of FAS who received IFNB-1a in CAMMS323 or CAMMS324 and who were treated with alemtuzumab in CAMMS03409.||Participants|||Count of Participants
797188|NCT00930553|Primary|Number of Participants With Sustained Accumulation of Disability (SAD)|"SAD: defined as an increase of at least 1.5 points in Expanded Disability Status Scale (EDSS) score for participants with prior study baseline score of 0 and increase of at least 1.0 point for participants with a prior study baseline score of 1.0 or more; and the increase persisted over a 6-month consecutive period. EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) and ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), higher scores indicating worse neurological function. Number of participants with SAD was estimated by Kaplan-Meier method and reported in this outcome measure. Baseline was defined as Year 0 of CAMMS323 and Year 0 of CAMMS324 for “alemtuzumab treatment CAMMS323 extension group and “alemtuzumab Treatment CAMMS324 Extension” group, respectively."|Baseline (Year 0) up to Year 6|Subset of full analysis set (FAS - defined as all participants randomized in CAMMS223, CAMMS323, and CAMMS324 and who received at least 1 dose of study drug) included participants who had received at least 1 dose of alemtuzumab in CAMMS323 and CAMMS324.||Participants|||Count of Participants
797189|NCT00930553|Primary|Annualized Relapse Rate (ARR) Before and After Alemtuzumab Retreatment|Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination, attributable to MS that last for at least 48 hours, present at normal body temperature, and that were preceded by at least 30 days of clinical stability. ARR was obtained from the total number of confirmed relapses that occurred during the treatment follow-up time of all participants divided by the sum of total follow-up time of all participants involved in certain treatment groups. ARR was estimated through negative binomial regression with robust variance estimation without covariate adjustment.|Year 1 prior to retreatment, Year 1, 2, 3 after retreatment|Subset of FAS included participants who had received alemtuzumab in CAMMS323 or CAMMS324 and received an additional course of alemtuzumab in this extension study.||relapses per participant per year||95% Confidence Interval|Number
797190|NCT00930553|Primary|Annualized Relapse Rate (ARR) Before and After Receiving Alemtuzumab|Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination, attributable to MS that last for at least 48 hours, present at normal body temperature, and that were preceded by at least 30 days of clinical stability. ARR was obtained from the total number of confirmed relapses that occurred during the treatment follow-up time of all participants divided by the sum of total follow-up time of all participants involved in certain treatment groups. ARR was estimated through repeated negative binomial regression with robust variance estimation and covariate adjustment for geographic region. The IFNB-1a/Alemtuzumab switch from CAMMS323 or CAMMS324 to CAMMS03409 pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting group.|Baseline (Year 0 of initial studies) up to Year 4|Subset of FAS who received IFNB-1a in CAMMS323 or CAMMS324 and who were treated with alemtuzumab in CAMMS03409.||relapses per participant per year||95% Confidence Interval|Number
797191|NCT00930553|Primary|Annualized Relapse Rate (ARR)|Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination, attributable to multiple sclerosis (MS) that last for at least 48 hours, present at normal body temperature, and that were preceded by at least 30 days of clinical stability. ARR was obtained from the total number of confirmed relapses that occurred during the treatment follow-up time of all participants divided by the sum of follow-up time of all participants involved in certain treatment groups. ARR was estimated through negative binomial regression with robust variance estimation.|"Year 3, 4, 5, 6 from the Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for “Alemtuzumab Treatment CAMMS323 Extension group and “Alemtuzumab Treatment CAMMS324 Extension” group, respectively)"|Subset of full analysis set (FAS - defined as all participants randomized in CAMMS223, CAMMS323, and CAMMS324 and who received at least 1 dose of study drug) included participants who had received at least 1 dose of alemtuzumab in CAMMS323 and CAMMS324. Number of participants analyzed = participants with available data for this outcome measure.||relapses per participant per year|||Number
797192|NCT00930644|Secondary|Number of Subjects Achieving PN/IV Reduction|The number of subjects who achieve at least 1-, 2-, and 3-day reductions in PN/IV per Week.|24 Months or Last Dosing Visit|||participants|||Number
797193|NCT00930644|Primary|Absolute Change in PN/IV Volume by Visit|The mean change from baseline in weekly PN.IV volume in Liters is shown by visit.|24 months|||Liters||Standard Deviation|Mean
797194|NCT00930644|Primary|Percent Change in PN/IV Volume by Visit|The mean change from baseline in weekly PN.IV volume in percent change is shown by visit.|24 months|||percent change||Standard Deviation|Mean
797195|NCT00930722|Secondary|Number of Participants With Preference for add-on Anti-hypertensive Therapy|The first add-on antihypertensive therapy for each participant was the first additional antihypertensive medication since initiation of Quinapril. If the participant did not require any such add-on medication, the first add-on antihypertensive therapy was “None”.|Baseline up to week 52 or early termination|FAS included all participants who received at least 1 dose of study medication including those who took it before enrollment. Missing values were not imputed.||Participants|||Number
797196|NCT00930722|Secondary|Mean Daily Dose of Study Medication|The mean daily dose of the study medication was calculated by dividing the total dose (sum of the daily doses) in the study by the treatment duration.|Baseline up to week 52 or early termination|FAS included all participants who received at least 1 dose of study medication including those who took it before enrollment. Missing values were not imputed.||mg||Standard Deviation|Mean
797197|NCT00930722|Secondary|Duration of Monotherapy With Quinapril|Time in weeks to the first “taking additional antihypertensive medication” since Quinapril therapy began.|Baseline up to week 52 or early termination|FAS included all participants who received at least 1 dose of study medication including those who took it before enrollment. Missing values were not imputed. Due to limited number of participants available, the analysis could not be performed.||Weeks||Inter-Quartile Range|Median
797198|NCT00930722|Secondary|Number of Participants With Achievement of BP Goal at Week 52|The status of achieving a participant’s goal BP at week 52 was yes (at goal) or no (not at goal). The BP goal also depended on the participant’s status of “DM or renal disease”. To be considered at goal, SBP/DBP must be less than 140/90 mmHg for participants without DM or renal disease and SBP/DBP must be less than 130/80 mmHg for participants with DM or renal disease.|Week 52|The FAS-FU included the subset of participants who had at least 1 additional BP measurement. This analysis was not conducted because only 2 participants were eligible for inclusion in the FAS-FU.||Participants|||Number
797199|NCT00930722|Secondary|Number of Participants Achieving BP Goal at Week 12|The status of achieving a participant’s goal BP at Week 12 was yes (at goal) or no (not at goal). The BP goal also depended on the participant’s status of “Diabetes Mellitus (DM) or renal disease”. To be considered at goal, SBP/DBP must be less than 140/90 mmHg for participants without DM or renal disease and SBP/DBP must be less than 130/80 mmHg for participants with DM or renal disease.|Week 12|FAS included all participants who received at least 1 dose of study medication including those who took it before enrolment. Subgroup analysis was performed for each subgroup of participants in the FAS defined by DM or renal disease status. Missing values were imputed by LOCF.||Participants|||Number
797200|NCT00930722|Secondary|Change From Pre-treatment in DBP at Week 0|Value at Week 0 minus value at pre-treatment. Pre-treatment BP was the last BP recorded before taking study medication from retrospective data. If no such value was available, the earliest retrospective BP value from medical records was considered.|Pre-treatment and Week 0|FAS included all participants who received at least 1 dose of study medication including those who took it before enrolment. Missing values were imputed by LOCF.||mmHg||Standard Deviation|Mean
797206|NCT00930722|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Any untoward medical occurrence in a participant who received study drug was considered an AE, without regard to possibility of causal relationship. Treatment-emergent adverse events (TEAE): those which occurred or worsened after baseline. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a SAE: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline to Week 52|Full analysis set (FAS) included participants who received at least 1 dose of study medication including those who took it before enrollment.||Participants|||Number
797207|NCT00930761|Secondary|Maternal Breastfeeding at 60 Days After Discharge|Maternal breastfeeding means exclusive maternal breastfeeding, predominant maternal breastfeeding (maternal milk associated to other liquid, except formula) and continuous maternal breastfeeding (maternal milk associate to other food, including formula).|At 60 days after the infant hospital discharge|||participants|||Number
797208|NCT00930761|Primary|Maternal Breastfeeding 7-15 Days After Discharge|Maternal breastfeeding means: exclusive maternal breastfeeding, predominant maternal breastfeeding (maternal milk associated to other liquid, except formula) and continuous maternal breastfeeding (maternal milk associate to other food, including formula).|At the first follow-up visit (7-15 days after discharge)|Analysis was by intention to treat (ITT)||participants|||Number
797209|NCT00930761|Secondary|Maternal Breastfeeding at 30 Days After Discharge|Maternal breastfeeding means exclusive maternal breastfeeding, predominant maternal breastfeeding (maternal milk associated to other liquid, except formula) and continuous maternal breastfeeding (maternal milk associate to other food, including formula).|At 30 days after the infant hospital discharge|Analysis by intention to treat (ITT)||participants|||Number
797210|NCT00930761|Primary|Maternal Breastfeeding at Infant Discharge|Maternal breastfeeding means exclusive maternal breastfeeding, predominant maternal breastfeeding (maternal milk associated to other liquid, except formula) and continuous maternal breastfeeding (maternal milk associate to other food, including formula).|At the time of the infant hospital discharge|Analysis by intention to treat (ITT)||participants|||Number
797211|NCT00930774|Secondary|Speech, Spatial and Qualities of Hearing Scale-comparative (SSQ-C)|Three subscale questionnaire that examines reported change in auditory disability for Speech, Spatial hearing and Quality of sounds. Subjects respond on a scale of -5 (‘much worse’) to +5 (much better) to indicate the change in difficulties following an intervention they have hearing in specific situations, with a lower number indicating greater difficulty. Results are presented for average total SSQ-C score which can range from -5 to +5, with higher scores indicating greater improvement.|Immediately post-intervention|The number of participants analyzed differs from the number of baseline enrollees due to participant attrition. Specifically, one individual in arm 1 (FM system), eleven participants in arm 2 (Auditory training), four in arm 3 (FM system and auditory training) and three in arm 4 (standard of care) chose not to attend the follow-up visit.||units on a scale||Standard Deviation|Mean
797212|NCT00930774|Secondary|Cognitive Self Report Questionnaire (CSRQ).|CSRQ assesses self-reported cognitive difficulties in 8 domains: Attention, Executive function, Memory, Language, Vision, Hearing, Energy,and Satisfaction. Participants respond on a 3-point Likert scale whether they perceived they improved, remained the same, or got worse as a result of an intervention. Total score is computed by summing scores on each subscale. Range for total score = -64 to +64, with higher scores indicating fewer reported cognitive difficulties.|Immediately post-intervention between weeks 8 and 12.|The number of participants analyzed differs from the number of baseline enrollees due to participant attrition. Specifically, one individual in arm 1 (FM system), eleven participants in arm 2 (Auditory training), four in arm 3 (FM system and auditory training) and three in arm 4 (standard of care) chose not to attend the follow-up visit.||units on a scale||Standard Deviation|Mean
797213|NCT00930774|Secondary|Time Compressed Speech Test (TCST)|the TCST assessed speech recognition for speeded speech. Sentences are presented in the sound field in quiet at with 50% and 60% time compression. Participants repeat back each sentence after it is presented.|Immediately post-intervention between weeks 8 and 12.|The number of participants analyzed differs from the number of baseline enrollees due to participant attrition. Specifically, one individual in arm 1 (FM system), eleven participants in arm 2 (Auditory training), four in arm 3 (FM system and auditory training) and three in arm 4 (standard of care) chose not to attend the follow-up visit.||percent correct||Standard Deviation|Mean
797214|NCT00930774|Secondary|Digit Span Score Measure of Auditory Working Memory|The Digit Span subtest of the Wechsler Adult Intelligence Scale 3rd edition (WAIS-III) assessed auditory working memory. It consists of a Digit Span Forward task in which individuals to repeat numbers in the same sequence as they were presented verbally, and a Digit Span Backward task in which individuals repeat back the numbers in the reverse order to which they were heard. Data are summed to compute a Digit Span total score. Possible range of scores is 0 to 30, with higher scores indicating better performance.|Immediately post-intervention between weeks 8 and 12.|The number of participants analyzed differs from the number of baseline enrollees due to participant attrition. Specifically, one individual in arm 1 (FM system), eleven participants in arm 2 (Auditory training), four in arm 3 (FM system and auditory training) and three in arm 4 (standard of care) chose not to attend the follow-up visit.||units on a scale||Standard Deviation|Mean
797215|NCT00930774|Secondary|Staggered Spondaic Word Test|Dichotic listening test in which two spondaic words are presented, one to each ear of the listener, in an overlapping fashion such that the first syllable of the first word is presented in isolation, the second syllable of the first word is presented simultaneously with the first syllable of the second word, and the second syllable of the second word is presented in isolation. Total number of test spondee pairs = 40.|Immediately post-intervention between weeks 8 and 12.|The number of participants analyzed differs from the number of baseline enrollees due to participant attrition. Specifically, one individual in arm 1 (FM system), eleven participants in arm 2 (Auditory training), four in arm 3 (FM system and auditory training) and three in arm 4 (standard of care) chose not to attend the follow-up visit.||total errors||Standard Deviation|Mean
797236|NCT00930930|Primary|Number of Patients With Pathological Complete Response|Pathological complete response is defined as no residual tumor on histopathological analysis of both breast and axillary contents.|at time of surgery, week 15-18|Number of patients that had complete response. Specimens containing only non-invasive disease will be classified as complete pathologic responders||participants|||Number
797216|NCT00930774|Secondary|Hearing in Noise Test|Hearing In Noise Test assesses speech understanding in noise assessed. Sentences are presented in a background of noise. The signal to noise ratio is varied adaptively to obtained the signal to noise ratio at which participants can correctly repeat back 50% of sentences presented in speech-shaped noise is determined. A lower signal to noise ratio indicates better performance.|Immediately post-intervention between weeks 8 and 12.|The number of participants analyzed differs from the number of baseline enrollees due to participant attrition. Specifically, one individual in arm 1 (FM system), eleven participants in arm 2 (Auditory training), four in arm 3 (FM system and auditory training) and three in arm 4 (standard of care) chose not to attend the follow-up visit.||Decibels (signal to noise ratio)||Standard Deviation|Mean
797217|NCT00930774|Primary|Stroop Color and Word Test|Measure of processing interference that assesses the ability to cope with cognitive stress and process complex input. It consists of a Word Page with color words printed in black ink, a Color Page with 'Xs' printed in color, and a Color-Word Page with words from the first page printed in colors from the second page (the color and the word do not match). The test-taker looks at each sheet and moves down the columns, reading words or naming the ink colors as quickly as possible within a time limit. Interference raw scores were converted into t-scores for analysis. T-score benefit was the analytic metric used. T-score benefit = post-intervention score minus baseline score|Baseline and Immediately post-intervention (between weeks 8 and 12).|The number of participants analyzed differs from the number of baseline enrollees due to participant attrition. Specifically, one individual in arm 1 (FM system), eleven participants in arm 2 (Auditory training), four in arm 3 (FM system and auditory training) and three in arm 4 (standard of care) chose not to attend the follow-up visit.||t-score benefit||Standard Deviation|Mean
797218|NCT00930774|Primary|Competence Score From the Psychosocial Impact of Assistive Devices Scale (PIADS)|Assesses the impact a rehabilitative intervention has on perceived Competence (perceived functional capability, independence and performance). Responses are reported on a 7-point scale that ranges from -3 (maximum negative impact) to +3 (maximum positive impact). The mid-point, zero, indicates no impact or no perceived change|Immediately post-intervention between weeks 8 and 12|The number of participants analyzed differs from the number of baseline enrollees due to participant attrition. Specifically, one individual in arm 1 (FM system), eleven participants in arm 2 (Auditory training), four in arm 3 (FM system and auditory training) and three in arm 4 (standard of care) chose not to attend the follow-up visit.||units on a scale||Standard Deviation|Mean
797219|NCT00930787|Primary|Incidence of Surgical Site Events (SSEs)||Postoperative Day 30|Study was terminated early and no analyses were conducted.|||||
797220|NCT00930813|Secondary|Serum Paclitaxel Levels - in Subsets of Patients||0, 1, 3 hours and pre-discharge||||||
797221|NCT00930813|Secondary|Change in Rutherford Grade||pre-procedure,6, 12 and 24 months||||||
797222|NCT00930813|Secondary|Change in Walking Impairment Questionnaire (WIQ)||pre-procedure, 6, 12 and 24 months||||||
797223|NCT00930813|Secondary|Change in Ankle-brachial Index||pre-procedure, 6, 12 and 24 months||||||
797224|NCT00930813|Secondary|Procedural Success|Completion of the procedure with less than 30% residual stenosis by QVA of the target lesion (after prolonged dilation and stenting, if necessary)|at procedure||||||
797225|NCT00930813|Secondary|Device Success|Successful delivery and deployment of the first inserted study device (in overlapping setting a successful delivery and deployment of the first and second study device) at the intended target lesion and successful withdrawal of the study device with attainment of final residual stenosis of less than 30% of the target lesion by quantitative vessel angiography (QVA).|at procedure||||||
797226|NCT00930813|Secondary|Target Vessel Revascularization||6, 12, 24 months||||||
797227|NCT00930813|Secondary|Target Lesion Revascularization||6, 12, 24 months||||||
797228|NCT00930813|Secondary|Primary Patency of Treated Segment||6, 12, 24 months||||||
797229|NCT00930813|Secondary|Safety - Device Related Adverse Events||30 days|ITT||participants|||Number
797230|NCT00930813|Primary|Angiographic Late Lumen Loss|Loss in analysis segment (the treated segment including 10mm distal and proximal) minimal lumen diameter from post-procedure through follow-up angiography at 6 months.|6 months|Intent-to-treat among completers, including all patients with valid angiographic imaging analyzable by the core lab.||mm||Standard Deviation|Mean
797231|NCT00930930|Other Pre-specified|Ability of p63 and p73 Gene Signatures to Predict Patient Response|To determine the levels of P63 and p73 in order to correlate these levels with patient response to treatment to help define a biomarker signature associated with p63/p73 dependence in triple negative breast cancers|Before treatment, on day 3-5 of week 1, and at week 12||||||
797232|NCT00930930|Other Pre-specified|Therapy-mediated Changes in Cell Cycle Position, Proliferation, and Apoptosis as Well as Status, Levels, and Phosphorylation State of p53, p73, and p63 and Select p53 Family Target Genes|To determine the relevance of pathway modulation in triple negative breast cancer cell networking|Before treatment, on day 3-5 of week 1, and at week 12||||||
797233|NCT00930930|Secondary|Number of Patients With Each Worst-grade Toxicity Response|Tables represent the number of patients with their worst-grade toxicity at each of five grades (grade 1, least severe to grade 5, most severe) following NCI Common Toxicity Criteria. Not all participants necessarily have an adverse event, thus not everyone will be accounted for in worst-grade toxicities. Likewise, one participant can potentially have more than one event in various grades 1-5 which accounts for the difference in number of patients analyzed and total number in the worst-grade toxicity tables.|week 12|Total number of patients reported with any toxicity related to study treatment.||participants|||Number
797234|NCT00930930|Secondary|Clinical Tumor Response to Neoadjuvant Therapy as Measured by Ultrasound Immediately Before Surgery|Per RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) > 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions|After treatment, week 12-15|Patients reported by best overall response data. Patients are excluded if best overall response data is not accessible or not evaluable.||participants|||Number
797235|NCT00930930|Secondary|Number of Patients That Underwent Breast Conservation Surgery|Defined as patients that did not undergo complete removal of a cancerous breast (mastectomy).|at the time of surgery, week 15-18|participants that had breast conservation surgery||participants|||Number
797237|NCT00930969|Secondary|Participants That Consented to Wear a Holter Monitor for a Period of 24 Hours to Collect Heart Sounds Data.|When study subjects completed their six-month follow-up visit, they were asked if they would consent to wear a Holter monitor for a period of 24 hours to collect Heart Sounds data. The study subject would have to return to the center the following day to return the Holter monitor and have their ICD EGM vectors reprogrammed.|Six-month follow-up visit|A subset of participants opting to wear a Holter monitor for 24 hours to collect Heart Sounds data, and then returning the following day for device reprogramming.||Participants|||Number
797238|NCT00930969|Secondary|Number of Years of Stored Data in a Database of the Hearts Electrical Activity in This Specific Patient Population to be Used for Future Research.|The device in this study included an additional capacity to collect and store information about the hearts electrical activity specific to ischemic heart disease. This additional capacity of the device is not currently available in market release ICDs. There is no measure to this objective, other than reporting the number of follow-up years of data accrued, which can be used by Medtronic for additional research.|Implant to 2 years|There were 175 subjects that consented to participate in the study, and two subjects were not implanted with an ICD by the time the study was terminated. Therefore the number of years of stored device data to utilize for future research as collected by the implanted ICD in the remaining 173 subjects was analyzed.||Years|||Number
797239|NCT00930969|Secondary|ST Segment Changes Measured by an ICD in Subjects Who Test Positive for Ischemia During an Exercise Stress Test|Patients underwent an exercise stress test at their one month study visit. This objective was to summarize the magnitude of the hearts electrical activity signal measured by the implanted ICD during a positive exercise stress test for ischemia.|One-month follow-up visit|||millivolts||Standard Deviation|Mean
797240|NCT00930969|Secondary|Occurrence of Spontaneous Coronary Event|During the study, spontaneous coronary ischemic events were categorized as STEMI, Non-ST elevated myocardial infarction (NSTEMI), or Unstable Angina. This objective was to provide estimates of rates per patient year for the study population. Rates are presented as: Average number of events per patient year (95% Confidence Interval)|Implant to 2 years|There were 175 subjects that consented to participate in the study, and two subjects were not implanted with an ICD by the time the study was terminated. Therefore data collected by the implanted ICD in the remaining 173 subjects was analyzed.||Events per patient year||95% Confidence Interval|Number
797241|NCT00930969|Primary|Number of Participants With ST Segment Changes During Myocardial Infarction|The primary objective of the study was to observe if there are any detectable ST segment changes on an electrogram (EGM) signal from an implanted cardiac defibrillator (ICD) during myocardial infarctions among study participants.|Implant to 2 years|During the study, none of the subjects presented with a ST Elevation Myocardial Infarction (STEMI). Therefore, there was not the opportunity to measure the hearts electrical activity during one of these events.||Participants|||Number
797242|NCT00930982|Other Pre-specified|Change From Baseline in Total Bacterial Load in the Sputum|Total bacterial load was determined in sputum collected before the inhalation of study drug. Sputum samples were either provided by the participant during the respective study visit, or participants had to bring a sputum sample that had been produced within the 4 hours prior to the visit. Induced sputum samples could be collected if the participant was unable to produce a spontaneously expectorated sputum sample of > 2 mL on Day 8. Imputation method: last observation carried forward (LOCF). CFU: colony forming units, log10: decadic logarithm|Baseline and up to end of study (planned at Day 84)|Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants. Decadic logarithm of colony forming units (CFUs) per gram sputum||log10 of CFU per gram sputum||Standard Deviation|Mean
797243|NCT00930982|Secondary|Emergence of Resistance Among Baseline Pathogens|The emergence of resistance (at least two-fold increase of Minimal inhibitory concentration, MIC, vs. baseline values) probably or possibly related to study medication among baseline pathogens was evaluated using microbiological analysis.|Up to end of study (planned at Day 84)|Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants.||Participants|||Number
797244|NCT00930982|Secondary|Emergence of New Potential Respiratory Pathogens|The emergence of new potential respiratory pathogens was evaluated using microbiological analysis. Evaluated was the cumulative number of participants with first appearance of new potential respiratory antigens at each time point. In some cases, participants attended the end of study visit later than Day 84 (up to Day 88).|Up to end of study (planned at Day 84)|Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants.||Cumulative participants|||Number
797245|NCT00930982|Secondary|Microbiological Response of Cipro Inhale Per Pathogen|Microbiological response was defined as reduction in bacterial load or eradication (measured as the number of participants with positive culture). Missing values were not imputed. Pathogens analyzed: Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Proteus mirabilis, Serratia marcescens, Pseudomonas aeruginosa, mucoid, Pseudomonas aeruginosa, non mucoid, Stenotrophomonas maltophilia, Achromobacter xylosoxydans, Moraxella catarrhalis, Haemophilus influenzae|Up to end of study (planned at Day 84)|Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants.||Participants|||Number
797246|NCT00930982|Secondary|Microbiological Response of Cipro Inhale Per Participant|Microbiological response was defined as reduction in bacterial load or eradication (measured as the percentage of participants with positive culture). Missing values were not imputed.|Up to end of study (planned at Day 84)|Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants.||Percentage of participants|||Number
797247|NCT00930982|Secondary|24-hour Sputum Color (Percentage of Participants With Non-clear Sputum)|Participants were asked to start 24-hour sputum collection samples 24 hours before coming for the respective study visit. Sputum color was assessed as either 'clear', or as 'yellow', 'green' or 'rust', or an assessment of 'no sputum' was made.|Up to end of study (planned at Day 84)|Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants.||Percentage of participants|||Number
797248|NCT00930982|Secondary|24-hour Sputum Volume|Participants were asked to start 24-hour sputum collection samples 24 hours before coming for the respective study visit. The volume of the completed sample was determined.|Up to end of study (planned at Day 84)|Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants.||mL||Standard Deviation|Mean
797249|NCT00930982|Secondary|Change From Baseline in Absolute Neutrophil Count (ANC)|Absolute neutrophil count (ANC) was determined from safety blood samples. Missing or invalid values were replaced with the last valid value available.|Baseline and up to Day 42|Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants.||giga/L||Standard Deviation|Mean
797250|NCT00930982|Secondary|Change From Baseline in High Sensitive C-reactive Protein (hsCRP)|High sensitive C-reactive protein (hsCRP) was determined from safety blood samples. Missing or invalid values were replaced with the last valid value available.|Baseline and up to Day 42|Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants.||mg/L||Inter-Quartile Range|Median
797251|NCT00930982|Secondary|Effect of Ciprofloxacin Inhale Treatment on Health-related Quality of Life (HRQoL) as Measured by Chronic Respiratory Questionnaire – Self Administered Standardized (CRQ-SAS)|Participants completed the Chronic Respiratory Questionnaire – Self Administered Standardized (CRQ-SAS). They were assured that all data would be treated confidentially and that the answers would not have any influence on study drug treatment. Participants completed the questionnaires on their own in a quiet area, without discussing them with study staff or accompanying persons (e.g. friends or relatives) and before being seen by the clinician. The score ranges between 1 and 7, 1 being the worst possible score.|Up to end of study (planned at Day 84)|Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants.||Total score on a scale||Standard Deviation|Mean
797252|NCT00930982|Secondary|Effect of Ciprofloxacin Inhale Treatment on Health-related Quality of Life (HRQoL) as Measured by the Saint George's Respiratory Questionnaire (SGRQ), Total Score|Participants completed the Saint George's Respiratory Questionnaire (SGRQ). They were assured that all data would be treated confidentially and that the answers would not have any influence on study drug treatment. Participants completed the questionnaires on their own in a quiet area, without discussing them with study staff or accompanying persons (e.g. friends or relatives) and before being seen by the clinician. The score ranges from 0 to 100 with 100 being the worst possible score.|Up to end of study (planned at Day 84)|Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants.||Scores on a scale||Standard Deviation|Mean
797253|NCT00930982|Secondary|Time to Exacerbation With Antibiotic Intervention|Acute exacerbation was defined according to the joint American Thoracic Society/European Respiratory Society criteria. For detailed information with regard to this definition of acute exacerbation, please refer to the detailed description in the protocol section. The time to an acute exacerbation with antibiotic intervention was determined.|Up to end of study (planned at Day 84)|Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants. NA: due to fewer than 25% of participants having an exacerbation||Days||Inter-Quartile Range|Median
797254|NCT00930982|Secondary|Change From Baseline in Forced Vital Capacity (FVC)|Pulmonary function testing (spirometry) was conducted in accordance with American Thoracic Society standards. FVC was defined as the maximal volume of air exhaled with maximally forced effort from a maximal inspiration, i.e. vital capacity performed with a maximally forced expiratory effort expressed in liters at BTPS. Imputation method: last observation carried forward (LOCF).|Baseline and up to end of study (planned at Day 84)|Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants.||Percent of predicted FVC||Standard Deviation|Mean
797255|NCT00930982|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)|Pulmonary function testing (spirometry) was conducted in accordance with American Thoracic Society standards. FEV1 was defined as the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration, expressed in liters at body temperature and ambient pressure saturated with water vapor (BTPS). Imputation method: last observation carried forward (LOCF).|Baseline and up to end of study (planned at Day 84)|Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants.||Percent of predicted FEV1||Standard Deviation|Mean
797256|NCT00930982|Primary|Change From Baseline in Total Bacterial Load in the Sputum at End of Treatment (Day 29).|Total bacterial load was determined in sputum collected before the inhalation of study drug. Sputum samples were either provided by the participant during the respective study visit, or participants had to bring a sputum sample that had been produced within the 4 hours prior to the visit. Induced sputum samples could be collected if the participant was unable to produce a spontaneously expectorated sputum sample of > 2 mL. Imputation method: last observation carried forward (LOCF). CFU: colony forming units, log10: decadic logarithm|Baseline and 29 days|Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants.||log10 of CFU per gram sputum||Standard Deviation|Mean
797257|NCT00931164|Secondary|Neuropsychological Tests||Week 14||||||
797258|NCT00931164|Secondary|Functional Skills Questionnaires||Week 14||||||
797259|NCT00931164|Secondary|Mood and Behavior Questionnaires||Week 14||||||
797260|NCT00931164|Secondary|Quality of Life Questionnaires||Week 14||||||
797261|NCT00931164|Secondary|Mean Daily Percentage of Time That Functional Status is Affected Due to Episodes||Week 14||||||
797262|NCT00931164|Primary|Number of Participants Who Reported Side Effects During Home Drug Maintenance Phase||1 year|||participants|||Number
797263|NCT00931164|Primary|Observed Safety Data During 5-day Hospitalization for Drug Dose Identification||Week 7||||||
797264|NCT00931164|Primary|Time Duration of AHC Episodes||Week 7||||||
797265|NCT00931242|Secondary|Number of Patients Achieving 50% Reduction in Eczema Area and Severity Index (EASI) Score at Week 12 in Reference to Week 0|EASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, edema, lichenification, and excoriations/erosions are scored on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 to 6. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score.|12 weeks|||participants|||Number
797266|NCT00931242|Secondary|Number of Patients Achieving 75% Reduction in Eczema Area and Severity Index (EASI) Score at Week 12 in Reference to Week 0|EASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, edema, lichenification, and excoriations/erosions are scored on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 to 6. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score.|12 weeks|||participants|||Number
797267|NCT00931242|Primary|Number of Patients Achieving an Improvement (Decrease) in IGA (Investigator Global Assessment) by Two or More Points|Improvement in IGA (Investigator Global Assessment) by two or more points on a five point scale, with 0 being no disease activity and 5 being maximum disease activity, at week 12|12 weeks|||participants|||Number
797268|NCT00931268|Secondary|Time Until it Became Impossible to Stay Sitting|Evaluation of when (in minutes) it became impossible for the subject to stay in the sitting position on a standardized chair, at the time points 1, 3, 6, 9, 12 and 18 months compared to baseline. In this analysis “more than 60 minutes” was handled as 60 minutes.|Baseline and at 6 months after treatment|The ITT population at 6 months comprised all 10 treated subjects.||minutes||Standard Deviation|Mean
797269|NCT00931268|Secondary|Adverse Event Recording|Adverse events (AEs) were collected by open questioning, investigator findings, spontaneous reports and by direct questioning in the Case Report Form (CRF).|Up to 18 months after treatment|Reported AEs, Safety population||participants|||Number
797270|NCT00931268|Secondary|Number of Participants With Gel Displacement Evaluated by Magnetic Resonance Imaging (MRI)|MRI was performed at baseline and at 1, 6, 9, and 12 months to determine the implant volume, thickness, localization and the possible local displacement of the implant. At the 6, 9 and 12 month visits any displacement was evaluated with MRI by comparison to the 1-month position of the gel. The number of participants with gel displacement are shown below.|12 months after treatment|||participants|||Number
797271|NCT00931268|Secondary|Number of Participants With Global Esthetic Improvement|Number of participants maintaining an improvement compared to baseline using the Global Esthetic Improvement Scale (GEIS) consisting of 5 grades (worse/no change/improved/much improved/very much improved), where the three latter indicates improvement. GEIS was assessed at the time points 1, 3, 6, 9, 12 and 18 months compared to pre-treatment photos.|One month and up to 18 months after treatment|The ITT population at 6 months comprised all 10 treated subjects.||participants|||Number
797272|NCT00931268|Secondary|Quality of Life Assessed by MOS-HIV (Medical Outcome Study-HIV) Questionnaire|A physical health summary score and a mental health summary score was generated on a rating scale of 0 to 100 where higher scores indicate better health. The change in health summary scores were assessed at the time points 3, 6, 9, 12 and 18 months compared to baseline.|Baseline and at 6 months after treatment|The physical and mental health summary scores at 6 months after treatment were compared to baseline. The ITT population comprised 8 of 10 treated subjects.||units on a scale||Standard Deviation|Mean
797273|NCT00931268|Secondary|Change From up to 18 Months to Baseline in Visual Analogue Scale (VAS) Pain After 15 Minutes of Sitting|Pain at sitting was evaluated using a 100 mm VAS with the descriptors 0 = “no pain” to the left and 100 = “worst possible pain” to the right. Pain was assessed by the subject after sitting 15 minutes on a standardized chair. The change in VAS pain was assessed at the time points 1, 3, 9, 12 and 18 months compared to baseline.|Baseline and up to 18 months after treatment|The VAS pain at 1, 3, 9, 12 and 18 months after treatment was compared to baseline. Of 10 treated subjects the ITT populations at each time point was: 9 (1 month), 8 (3 months), 7 (9 months), 5 (12 months) and 4 (18 months).||mm||Standard Deviation|Mean
797274|NCT00931268|Primary|Change From 6 Months to Baseline in Visual Analogue Scale (VAS) Pain After 15 Minutes of Sitting|Pain at sitting was evaluated using a 100 mm VAS with the descriptors 0 = “no pain” to the left and 100 = “worst possible pain” to the right. Pain was assessed by the subject after sitting 15 minutes on a standardized chair. The VAS pain at 6 months was compared to baseline and the change was calculated.|6 months after treatment compared to baseline|All efficacy analyses were performed using the intention to treat (ITT) population. The ITT population at baseline and 6 months comprised all 10 treated subjects.||mm||Standard Deviation|Mean
797275|NCT00931307|Primary|Comfort After Insertion|Comfort after insertion of contact lens (30 seconds to 1 minute), as interpreted by the subject and reported by the subject as a single, retrospective evaluation of 3-month’s wear time. Comfort after insertion was measured on a 10-point scale, with 1 being poor and 10 being excellent.|3 months|Per protocol. Analysis excluded major protocol deviations as determined by masked review.||Scale of 1 to 10||Standard Deviation|Mean
797276|NCT00931359|Secondary|Percentage of Subjects With Reported Adverse Events|Adverse events were defined in the protocol and included anticipated side effects of the procedure. These events were tracked by the clinical site and did include subject-reported events. The events reported here only included side effects that were attributed by the principal investigator as being possibly to definitely related to the device or procedure. They did not include expected treatment effects, such as swelling or bruising in the treatment area.|6 months post-treatment|||Percentage of Participants|||Number
797277|NCT00931359|Secondary|Percentage of Treatment Group Subjects That Report an HDSS Score of 1 or 2 at the 12 Month Visit|"The Hyperhidrosis Disease Severity Scale (HDSS) is a 4-point validated scale for measuring the effect of excessive sweating.
- My underarm sweating is never noticeable and never interferes with my daily activities
- My underarm sweating is tolerable but sometimes interferes with my daily activities
- My underarm sweating is barely tolerable and frequently interferes with my daily activities
- My underarm sweating is intolerable and always interferes with my daily activities This outcome is only measured for the treatment group; sham group exited the study after 6 month visit."|12 months|Sham group subjects exited the study after the 6 month follow-up visit, so were not in the study at this timepoint.||Percentage of Participants|||Number
797278|NCT00931359|Secondary|Percentage of Subjects That Report an HDSS Score of 1 or 2 at the 6 Month Follow-up Visit.|"The Hyperhidrosis Disease Severity Scale (HDSS) is a validated scale for measuring the effect of excessive sweating on the quality of life. It is a 4-point scale, with the following descriptors:
- My underarm sweating is never noticeable and never interferes with my daily activities
- My underarm sweating is tolerable but sometimes interferes with my daily activities
- My underarm sweating is barely tolerable and frequently interferes with my daily activities
- My underarm sweating is intolerable and always interferes with my daily activities"|6 months post-treatment|||Percentage of Participants|||Number
797279|NCT00931359|Primary|Percentage of Subjects That Report an HDSS Score of 1 or 2 at 30 Days.|"The Hyperhidrosis Disease Severity Scale (HDSS) is a validated scale for measuring the effect of excessive sweating on the quality of life. It is a 4-point scale, with the following descriptors:
- My underarm sweating is never noticeable and never interferes with my daily activities
- My underarm sweating is tolerable but sometimes interferes with my daily activities
- My underarm sweating is barely tolerable and frequently interferes with my daily activities
- My underarm sweating is intolerable and always interferes with my daily activities"|30 days post-treatment|Intent to Treat Population was used. Last Observation Carry Forward was used for missing data.||Percentage of Participants|||Number
797280|NCT00931385|Secondary|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG|Clinical relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsenings of baseline conditions were reported as Adverse Events related to treatment (cardiac disorders and investigations).|6 weeks|Treated set.||participants|||Number
797281|NCT00931385|Secondary|Trough FVC Response|Response was defined as change from baseline. Study baseline trough FVC was defined as the mean of the available pre-dose trough FVC values at the randomisation visit. Trough values were obtained 30 minutes prior to the last am dose of study drug after six weeks of treatment . Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random.|Baseline and 6 weeks|FAS||Liter||Standard Error|Least Squares Mean
797282|NCT00931385|Secondary|Peak FVC (0-3h) Response|Response was defined as change from baseline. Study baseline peak FVC was defined as the mean of the available pre-dose peak FVC values at the randomisation visit. Peak FVC (0-3h) was obtained within 0 - 3 hours after the last am dose of study drug after 6 weeks of treatment. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random.|Baseline and 6 weeks|FAS||Liter||Standard Error|Least Squares Mean
797283|NCT00931385|Secondary|FVC Area Under Curve 0-24 Hours (AUC 0-24h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FVC AUC 0-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 h and 10 min prior to am dose on the first day of treatment (baseline) and -30 min, 30 min, 60 min, 2h, 3h, 4h, 6h, 8h, 10h, 11 hr 50 min,12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment.|FAS||Liter||Standard Error|Least Squares Mean
797284|NCT00931385|Secondary|FVC Area Under Curve 12-24 Hours (AUC 12-24h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FVC AUC 12-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 h and 10 min prior to am dose on the first day of treatment (baseline) and 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment|FAS||Liter||Standard Error|Least Squares Mean
797285|NCT00931385|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-12 Hours (AUC 0-12h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FVC AUC 0-12h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to am dose on the first day of treatment (baseline) and -30 min (zero time), 30 min, 60 min, 2 hour (h) , 3 h, 4 h, 6 h, 8 h, 10 h, 11 h 50 min relative to am dose after six weeks of treatment|FAS||Liter||Standard Error|Least Squares Mean
797286|NCT00931385|Secondary|Trough FEV1 Response|Response was defined as change from baseline. Study baseline trough FEV1 was defined as the mean of the available pre-dose trough FEV1 values at the randomisation visit. Trough values were obtained 30 minutes prior to the last am dose of study drug after six weeks of treatment . Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random.|Baseline and 6 weeks|FAS||Liter||Standard Error|Least Squares Mean
797287|NCT00931385|Secondary|Peak FEV1 (0-3h) Response|Response was defined as change from baseline. Study baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values at the randomisation visit. Peak (0-3h) values were obtained within 0 - 3 hours after the last am dose after six weeks of treatment. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random.|Baseline and 6 weeks|FAS||Liter||Standard Error|Least Squares Mean
797288|NCT00931385|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response After Six Weeks of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FEV1 AUC 0-3h was calculated from 0-3hours post-dose using the trapezoidal rule, divided by the observation time (3 h) to report in litres.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -30 min, 30 min, 60 min, 2 h , 3 h, relative to the last am dose after six weeks of treatment|FAS||Liter||Standard Error|Least Squares Mean
797312|NCT00931528|Secondary|Patient-related Predictors of EF at Weeks 28-30 and Years 1 and 2 After Initiation of RT||Baseline to 2 years from the start of radiation therapy||||||
797313|NCT00931528|Secondary|Patient and Partner Marital Adjustment as Measured by the Locke's Marital Adjustment Test at Weeks 28-30 and Years 1 and 2 After Initiation of RT||Baseline to 2 years from the start of radiation therapy||||||
797289|NCT00931385|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-24 h (AUC 0-24h) Response After Six Weeks of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random.FEV1 AUC 0-24h was calculated from 0-24 hours post-dose using the trapezoidal rule, divided by the observation time (24h) to report in litres.|1 h and 10 min prior to am dose on the first day of treatment (baseline) and -30 min, 30 min, 60 min, 2h, 3h, 4h, 6h, 8h, 10h, 11 hr 50 min,12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment.|FAS||Liter||Standard Error|Least Squares Mean
797290|NCT00931385|Primary|FEV1 Area Under Curve 12-24h (AUC 12-24h) Response After Six Weeks of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed in the morning of the first treatment visit, just prior to administration of the morning dose of randomized treatment. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FEV1 AUC 12-24h was calculated from 12-24 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 h and 10 min prior to am dose on the first day of treatment (baseline) and 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment|FAS||Liter||Standard Error|Least Squares Mean
797291|NCT00931385|Primary|FEV1 Area Under Curve 0-12 h (AUC 0-12h) Response After Six Weeks of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed in the morning of the first treatment visit, just prior to administration of the morning dose of randomized treatment. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FEV1 AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 hour (h) and 10 minutes (min) prior to am dose on the first day of treatment (baseline) and -30 min (zero time), 30 min, 60 min, 2 hour (h) , 3 h, 4 h, 6 h, 8 h, 10 h, 11 h 50 min relative to am dose after six weeks of treatment|Full analysis set (FAS). FAS is defined as all patients with the baseline (pre-dose) data and any evaluable post-dosing data for the first co-primary endpoint FEV1AUC 0-12h.||Liter||Standard Error|Least Squares Mean
797292|NCT00931411|Secondary|Preferred Formulation|Number of participants that preferred one formulation over the other. All patients started the study with one cream and crossed over to the other cream at Day 42 for another 14 days. Participants were asked which they prefered.|56 days|All subjects with an evaluation after the Day 42 visit were included in this evaluation if their overall compliance was between 70 and 120%. Two patients lost to follow-up, one with no Day 56 value and 5 less than 70% compliant were not included in this analysis.||Participants|||Number
797293|NCT00931411|Secondary|Change in Mean Tolerance After Crossover|"Tolerance of study products assessed by investigator during the 2 weeks following the crossover (Day 56 of the study):
1) Very good tolerance: no objective or subjective intolerance during the study
2) Good tolerance: very occasional symptoms, not resulting in cessation of applications, no objective sign
3) Average tolerance: repeated symptoms of intolerance, no cessation of application and no objective sign
4) Poor tolerance: symptoms requiring cessation of application, no objective sign
5) Very poor tolerance: objective signs of irritative or allergic dermatitis"|14 Days (Day 42 to Day 56 of the study)|All subjects that had at least one evaluation after Day 7 (no day 0 visit for this parameter) were included in the analysis. Missing data were replaced using the last observation carried forward method. The same patients as in outcome #7 did not have results to carry forward and were not included in analysis (subjects swapped after crossover).||Units on a scale||Standard Deviation|Mean
797294|NCT00931411|Secondary|Change in Tolerance Before Crossover|"Tolerance of study products assessed by investigator at Day 7, 42. It was evaluated using the following scale:
1) Very good tolerance: no objective or subjective intolerance during the study
2) Good tolerance: very occasional symptoms, not resulting in cessation of applications, no objective sign
3) Average tolerance: repeated symptoms of intolerance, no cessation of application and no objective sign
4) Poor tolerance: symptoms requiring cessation of application, no objective sign
5) Very poor tolerance: objective signs of irritative or allergic dermatitis"|7, 42 days|All subjects that had at least one evaluation after the Day 7 (no Day 0 visit for this parameter) visit were included in the efficacy evaluations. Missing data were replaced using the last observation carried forward (LOCF) method. Four patients had no Day 7 visit to carry forward and were not included in this analysis.||Units on a scale||Standard Deviation|Mean
797295|NCT00931411|Secondary|Change in Mean Cosmetic Acceptability After Crossover|The cosmetic acceptability of formulation 609580 20 compared to formulation 609209 as measured by the total score in the cosmetic acceptability questionnaire during the 2 week period after the crossover. Scale from 44 (worst) to -44 (best). The 14 Days after the crossover is the same as Day 56 in the study.|14 days (Day 42 to Day 56 of the study)|Subjects that had at least one evaluation after the Day 0 visit were in analysis if they had overall compliance between 70 and 120%. Missing data were imputed using last observation carried forward. Two patients lost to follow-up, 1 early term and 5 less than 70% compliant were not included in this analysis and participants swapped after crossover.||Units on a scale||Standard Deviation|Mean
797296|NCT00931411|Secondary|Change in Mean Cosmetic Acceptability Before Crossover|The cosmetic acceptability of formulation 609580 20 compared to formulation 609209 as measured by the total score in the cosmetic acceptability questionnaire during the first 42 prior to the crossover. Scale from 44 (worst) to -44 (best).|0, 42 days|All subjects with at least one evaluation after the Day 0 visit were included in the cosmetic evaluation if their overall compliance between 70 and 120%. Missing data were imputed using last observation carried forward (LOCF). Two patients lost to follow-up, and 5 less than 70% compliant were not included in this analysis.||Units on a scale||Standard Deviation|Mean
797297|NCT00931411|Secondary|Change in Mean Quality of Life|The effect of formulation 609580 20 to improve quality of life compared to formulation 609209 as measured by changes in the quality of life questionnaire score from Day 0 to Day 42. Scale from -46 (worst) to 46 (best).|0, 42 days|All subjects with at least one evaluation after the Day 0 visit were included in this evaluation if their overall compliance between 70 and 120%. Missing data were imputed using last observation carried forward (LOCF). Two patients lost to follow-up, and 5 less than 70% compliant were not included in this analysis.||Units on a scale||Standard Deviation|Mean
797298|NCT00931411|Secondary|Change in Mean Global Efficacy (by Parent)|"The efficacy of formulation 609580 20 to provide relief to children with atopic dermatitis compared to formulation 609209 as measured by the global efficacy evaluation scale at Day 7 and Day 42 (by parent).
0 = worsening
1 = No change
2 = Mild Improvement
3 = Moderate Improvement
4 = Good Improvement
5 = Excellent Improvement"|7, 42 days|All subjects with all evaluations after the Day 0 visit were included in this evaluation if their overall compliance was >70 and <120%. Missing data were imputed using last observation carried forward (LOCF). Two patients lost to follow-up, two missing Day 7 value and 5 less than 70% compliant were not included in this analysis.||Units on a scale||Standard Deviation|Mean
797299|NCT00931411|Secondary|Change in Mean Global Efficacy (by Investigator).|"The efficacy of formulation 609580 20 to provide relief to children with atopic dermatitis compared to formulation 609209 as measured by the global efficacy evaluation scale at Day 7 and Day 42 (by investigator).
0 = worsening
1 = No change
2 = Mild Improvement
3 = Moderate Improvement
4 = Good Improvement
5 = Excellent Improvement"|7, 42 Days|All subjects with all evaluations after the Day 0 visit were included in this evaluation if their overall compliance was >70 and <120%. Missing data were imputed using last observation carried forward (LOCF). Two patients lost to follow-up, one missing Day 7 value and 5 less than 70% compliant were not included in this analysis.||Units on a scale||Standard Deviation|Mean
797300|NCT00931411|Primary|Mean Percent Change in SCORAD (Scoring Atopic Dermatitis) From Day 0|The efficacy of formulation 609580 20 to provide relief to children with atopic dermatitis compared to formulation 609209 as measured by the changes in SCORAD at Day 7 and Day 42. It measures intensity of erythema/darkening, edema/papulation, oozing/crust, excoriation, lichenfinication/prurigo and dryness on a scale from 0-3 for a total of 18 points. This score is multiplided by 3.5 and added to 1/5 of the affected percent body surface area. The final score is added to the score from a 10-point pruritus visual analog scale (VAS) and a 10-point loss of sleep VAS. Best score is 0, worst is 103.|7 , 42 days|All subjects that had at least one evaluation after the Day 0 visit were included in the efficacy evaluations if their overall compliance was between 70 and 120%. Missing data were replaced using the last observation carried forward (LOCF) method. Two patients lost to follow-up and 5 less than 70% compliant were not included in this analysis.||Percentage of change in SCORAD||Standard Deviation|Mean
797301|NCT00931463|Secondary|Participants With Plasma HIV RNA < 200 Copies/mL 48 Weeks After Randomization, Per-protocol Population, VL Less Than or Equal to 100,000 Copies Per mL|The per- protocol population includes those participants who fulfil the protocol in the terms of the eligibility, interventions, and outcome assessment|48 weeks|Baseline viral load <=100,000 copies per mL||participants|||Number
797302|NCT00931463|Secondary|Participants With Plasma HIV RNA < 200 Copies/mL 48 Weeks After Randomization, Per-protocol Population, Baseline VL >100,000 Copies Per mL|The difference between treatment arms in proportion of participants with plasma HIV RNA < 200 copies/mL 48 weeks after randomization, per-protocol population: stratified analysis by baseline plasma viral load (less than or equal to 100,000 copies per mL or >100,000 copies per mL) on those participants who fulfil the protocol in the terms of the eligibility, interventions, and outcome assessment|48 weeks|Baseline viral load >100,000 copies per mL||participants|||Number
797303|NCT00931463|Secondary|Participants With Plasma HIV RNA < 200 Copies/mL 48 Weeks After Randomization, Per-protocol Population, Non-completer Classed as Failure|"The non-completer classed as failure analysis will include all randomised participants; participants who meet the following criteria will be defined as failures:
i. week 48 HIV RNA being above each threshold ii. has missing HIV-1 RNA data for any reason iii. stops randomly assigned therapy"|48 weeks|Non-completer classes as failure||participants|||Number
797304|NCT00931463|Secondary|Participants With Plasma HIV RNA < 200 Copies/mL 48 Weeks After Randomization, Per-protocol Population|The per- protocol population includes those participants who fulfil the protocol in the terms of the eligibility, interventions, and outcome assessment|48 weeks|Per protocol||participants|||Number
797305|NCT00931463|Primary|Participants With Plasma HIV RNA < 200 Copies/mL 48 Weeks After Randomization||48 weeks following randomization|modified intention-to-treat||participants|||Number
797306|NCT00931489|Secondary|Change in Ocular Coherence Tomography (OCT) From Baseline to Month 6|Ocular Coherence Tomography (OCT) was used to measure retinal central foveal thickness. The mean change from baseline to 6 months was determined and recorded in micrometers (µm).|6 months|"At the 6 month timepoint - 3 of the 40 subjects enrolled into Group 1 (Wet AMD responders) had been moved to Group 3 due to persistent subretinal fluid on OCT (protocol definition of non-responder following 4 months of treatment)."||µm||Full Range|Mean
797307|NCT00931489|Secondary|Change in Visual Acuity (VA) From Baseline to Month 6|Subjects visual acuity (VA) was tested using Early Treatment Diabetic Retinopathy Study (ETDRS) charts. Letters correctly read on ETDRS chart was recorded at baseline and 6 months. Mean change was measured.|6 months|"At the 6 month timepoint - 3 of the 40 subjects enrolled into Group 1 (Wet AMD responders) had been moved to Group 3 due to persistent subretinal fluid on OCT (protocol definition of non-responder following 4 months of treatment)."||letters gained||Full Range|Mean
797308|NCT00931489|Primary|"Production of Anti-Retinal Pigment Epithelium (RPE) or Anti-retinal Antibody Formation in Neovascular (Wet) Age-related Macular Degeneration Patients Compared to Population Normals."|Blood samples were collected from all study participants at baseline and Western Blot analysis was performed to identify the presence of anti-retinal and anti-RPE antibodies. Presented are the number of subjects in which the presence of anti-retinal and anti-RPE antibodies (yes/no) were recorded by a masked observer.|6 months|"The wet AMD patients' 6 month values in production of RPE or anti-retinal antibody formation are being compared to the Normal Population baseline values."||participants|||Number
797309|NCT00931515|Primary|Participants With Improved Patient Function|"The comparison of results was based on the proportion of participants with improved outcomes.
The primary efficacy variable was treatment success based on the following criteria:
Oswestry Disability Index score improved by at least 15 points
Device success
Neurological success
Absence of major complications
Absence of fusion at the index level A patient was considered a success upon meeting all five criteria. Failure to meet any of these criteria resulted in classification as a treatment failure."|24 months|||participants|||Number
797310|NCT00931528|Secondary|Radiotherapy Factors Associated With Spontaneous (Off-drug) EF at Weeks 28-30 and Years 1 and 2 After Initiation of RT||Baseline to 2 years from the start of radiation therapy||||||
797311|NCT00931528|Secondary|Patient Follow-up Treatment for Erectile Dysfunction at Weeks 28-30 and Years 1 and 2 After Initiation of RT||Baseline to 2 years from the start of radiation therapy||||||
797317|NCT00931528|Primary|Spontaneous (Off-drug) Erectile Function (EF) as Measured by International Index of Erectile Function (IIEF) at Weeks 28-30 After Initiation of Radiation Therapy (RT)|The primary endpoint is maintenance of spontaneous (off-drug) erectile function at weeks 28-30 after initiation of RT, as measured by the IIEF Q1. All patients have erectile function prior to initiation of RT, indicated by a score of 3, 4, or 5 on IIEF Q1. Patients with a lower IIEF Q1 score at weeks 28-30 than at baseline will have less erectile function and be categorized as nonresponders. Patients with similar or improved erectile function will be categorized as responders. We hypothesize that the proportion of patients maintaining erectile function while receiving tadalafil (Arm 1) will be significantly higher than for patients receiving placebo treatment (Arm 2). Treatment differences will be tested at the 0.05 significance level using the Fisher exact test. Point estimates and 95% confidence intervals will also be provided.|Baseline to 30 weeks from the start of radiation therapy|All randomized eligible patients with IIEF at both baseline and 30 week time point.||percentage of participants||95% Confidence Interval|Number
797320|NCT00931710|Secondary|Cumulative Percentage of Patients With Incidence of Peripheral Edema Before or at the Corresponding Visit|To assess the incidence of peripheral edema occurring with valsartan/amlodipine-based regimen versus losartan-based regimen in patients with Stage 2 systolic hypertension.|3, 6, 9 and 12 weeks|Full Analysis Set (FAS).||cumulative percentage of patients|||Number
797321|NCT00931710|Secondary|Change in Mean Sitting Systolic and Diastolic Blood Pressure After 12 Weeks|To compare the change from baseline in MSSBP and MSDBP after 12 weeks of valsartan/amlodipine-based regimen with losartan-based regimen in patients with Stage 2 systolic hypertension.|Baseline to week 12|Full Analysis Set (FAS). Last observation carried forward (LOCF).||mmHg||Standard Deviation|Mean
797322|NCT00931710|Secondary|Cumulative Percentage of Treatment Responders|To compare the percentage of treatment responders (defined as patients with MSSBP < 140 mmHg or demonstrating a decrease from baseline of ≥ 20 mmHg) after 3 and 6 weeks of valsartan/amlodipine-based regimen with losartan-based regimen in patients with Stage 2 systolic hypertension.|3 and 6 weeks|Full Analysis Set (FAS).||Cumulative percentage of responders|||Number
797323|NCT00931710|Secondary|Cumulative Percentage of Patients Achieving Blood Pressure Control|To compare the percentage of patients achieving blood pressure control (defined as patients achieving MSSBP < 140 mmHg and MSDBP < 90 mmHg) after 3 and 6 weeks of valsartan/amlodipine-based regimen with losartan-based regimen in patients with Stage 2 systolic hypertension.|3 and 6 weeks|Full Analysis Set (FAS).||cumulative percentage of patients|||Number
797324|NCT00931710|Secondary|Change in Mean Sitting Diastolic Blood Pressure After 6 Weeks|To compare the change from baseline in mean sitting diastolic blood pressure (MSDBP) after 6 weeks of valsartan/amlodipine-based regimen with losartan-based regimen in patients with Stage 2 systolic hypertension.|Baseline to Week 6|Full Analysis Set (FAS). Last observation carried forward (LOCF).||mmHg||Standard Deviation|Mean
797325|NCT00931710|Primary|Change in Mean Sitting Systolic Blood Pressure After 6 Weeks|To compare the change from baseline in mean sitting systolic blood pressure (MSSBP) after 6 weeks of valsartan/amlodipine-based regimen with a losartan-based regimen in patients with Stage 2 systolic hypertension.|Baseline to Week 6|Full Analysis Set (FAS). Last observation carried forward (LOCF).||mmHg||Standard Deviation|Mean
797326|NCT00931723|Secondary|Change From Baseline to Day 43 in Each YMRS Item Score No. 11|The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4. This analysis is for Item 11 (insight) which ranges from 0 to 4 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Change from baseline to Day 43|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).||Scores on a scale||Standard Error|Least Squares Mean
797327|NCT00931723|Secondary|Change From Baseline to Day 43 in Each YMRS Item Score No. 10|The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4. This analysis is for Item 10 (appearance) which ranges from 0 to 4 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Change from baseline to Day 43|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).||Scores on a scale||Standard Error|Least Squares Mean
797328|NCT00931723|Secondary|Change From Baseline to Day 43 in Each YMRS Item Score No. 9|The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4. . This analysis is for Item 9 (disruptive-aggressive behavior) which ranges from 0 to 8 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Change from baseline to Day 43|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).||Scores on a scale||Standard Error|Least Squares Mean
797329|NCT00931723|Secondary|Change From Baseline to Day 43 in Each YMRS Item Score No. 8|The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4. This analysis is for Item 8 (content) which ranges from 0 to 8 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Change from baseline to Day 43|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).||Scores on a scale||Standard Error|Least Squares Mean
799719|NCT00958308|Secondary|Safety Profile of BIO-K+CL1285® Versus Placebo in Hospitalized Patients.|Adverse events were reported by patients in the three study groups.|Up to 40 days||||||
797330|NCT00931723|Secondary|Change From Baseline to Day 43 in Each YMRS Item Score No. 7|The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4. This analysis is for Item 7 (language-thought disorder) which ranges from 0 to 4 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Change from baseline to Day 43|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).||Scores on a scale||Standard Error|Least Squares Mean
797331|NCT00931723|Secondary|Change From Baseline to Day 43 in Each YMRS Item Score No. 6|The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4 (0=normal). This analysis is for Item 6 (speech-rate and amount) which ranges from 0 to 8 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Change from baseline to Day 43|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).||Scores on a scale||Standard Error|Least Squares Mean
797332|NCT00931723|Secondary|Change From Baseline to Day 43 in Each YMRS Item Score No. 5|The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4 (0=normal). This analysis is for Item 5 (Irritability) which ranges from 0 to 8 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Change from baseline to Day 43|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).||Scores on a scale||Standard Error|Least Squares Mean
797333|NCT00931723|Secondary|Change From Baseline to Day 43 in Each YMRS Item Score No. 4|The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4 (0=normal). This analysis is for Item 4 (sleep) which ranges from 0 to 4 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Change from baseline to Day 43|||Scores on a scale||Standard Error|Least Squares Mean
797334|NCT00931723|Secondary|Change From Baseline to Day 43 in Each YMRS Item Score No. 3|The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4 (0=normal). This analysis is for Item 3 (sexual interest) which ranges from 0 to 4 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Change from baseline to Day 43|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).||Scores on a scale||Standard Error|Least Squares Mean
797335|NCT00931723|Secondary|Change From Baseline to Day 43 in Each YMRS Item Score No. 2|The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4 (0=normal). This analysis is for Item 2 (increased motor activity-energy) which ranges from 0 to 4 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Change from baseline to Day 43|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).||Scores on a scale||Standard Error|Least Squares Mean
797336|NCT00931723|Secondary|Change From Baseline to Day 43 in Each YMRS Item Score No. 1|The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4 (0=normal). This analysis is for Item 1 (Elevated mood) which ranges from 0 to 4 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Change from baseline to Day 43|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).||Scores on a scale||Standard Error|Least Squares Mean
797337|NCT00931723|Secondary|Change From Baseline to Day 43 in PANSS Positive Subscale Score|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia and are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS positive subscale score is the sum of the 7 positive item scores (ie, delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution and hostility) and ranges from 7 to 49. A negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Change from baseline to Day 43|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).||Scores on a scale||Standard Error|Least Squares Mean
797338|NCT00931723|Secondary|Change From Baseline to Day 43 in PANSS Activation Subscale Score|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia and are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS activation subscale score for effect on agitation and aggression is the sum of 6 PANSS individual items (ie, hostility, poor impulse control, excitement, uncooperativeness, poor rapport and tension) and ranges from 6 to 42. A negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Change from baseline to Day 43|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).||Scores on a scale||Standard Error|Least Squares Mean
797349|NCT00931801|Secondary|The Difference in CD4 From Baseline to Week 48|Change in mean CD4 from Baseline to Week 48.|Baseline and Week 48|Values included for all enrolled participants excluding participants with confirmed virologic failure or those missing values due to early withdrawal, loss to follow-up or lab error.||cells/mm3||Standard Deviation|Mean
797339|NCT00931723|Secondary|Change From Baseline to Day 43 in Positive and Negative Syndrome Scale (PANSS) Total Score|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia and are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score is the sum of all 30 individual-item scores and ranges from 30 to 210.A negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Change from baseline to Day 43|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).||Scores on a scale||Standard Error|Least Squares Mean
797340|NCT00931723|Secondary|Change From Baseline to Day 43 in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score|The MADRS is a 10-item scale that evaluates depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. Higher MADRS scores indicate higher levels of depressive symptoms.|Change from baseline to Day 43.|||Scores on a scale||Standard Error|Least Squares Mean
797341|NCT00931723|Secondary|Improvement of Overall Bipolar Illness|"The number of patients with a CGI-BP-C of “Much” or “Very much” improved in overall bipolar illness assessment at Day 43 was calculated.
The CGI-BP-C scale rates how much the patient’s illness has improved or worsened compared to the phase immediately preceding treatment and is scored on a scale from 1 to 8 (1=very much improved to 7=very much worse; 8=not applicable). A missing score will be used when a scale scored as 8 (not applicable). CGI-BP-C scores >4 indicate worsening, while scores <4 indicate improvement."|Day 43.|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).||Participants|||Number
797342|NCT00931723|Secondary|Change From Baseline to Day 43 in CGI-BP-C (Clinical Global Impressions for Bipolar Disorder-Change From Preceding Phase)|The CGI-BP-C scale rates how much the patient’s illness has improved or worsened compared to the phase immediately preceding treatment and is scored on a scale from 1 to 8 (1=very much improved to 7=very much worse; 8=not applicable). A missing score will be used when a scale scored as 8 (not applicable). CGI-BP-C scores >4 indicate worsening, while scores <4 indicate improvement.|Change from baseline to Day 43|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).||Scores on a scale||Standard Error|Least Squares Mean
797343|NCT00931723|Secondary|Change From Baseline to Day 43 in CGI-BP-S (Clinical Global Impressions for Bipolar Disorder-Severity of Illness)|The CGI-BP-S scale rates the severity of the patient’s illness at the time of assessment and is scored from 1 to 7 (1=normal, not ill to 7=very severely ill). Higher CGI-BP-S scores indicate greater illness severity.|Change from baseline to Day 43.|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).||Scores on a scale||Standard Error|Least Squares Mean
797344|NCT00931723|Secondary|Remission|"The number of patients with clinically significant remission (defined as YMRS total score ≤12) from Days 8 to 43) was calculated.
The Young Mania Rating Scale total score ranges from 0 to 60 where higher scores indicate more severe mania, thus, a negative change (or 50% reduction) from baseline indicates a reduction (or improvement) in manic symptoms. Total score ≤12 indicates remission (13-19=minimal symptoms; 20-25=mild mania, 26-37=moderate mania, 38-60=severe mania)."|Days 8 to 43|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).||Participants|||Number
797345|NCT00931723|Secondary|The Number of Patients With Clinically Significant Response.|The number of patients with clinically significant response (defined as ≥50% reduction from baseline to Day 43 in the YMRS total score) was calculated. The YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania, thus, a negative change (or 50% reduction) from baseline indicates a reduction (or improvement) in manic symptoms.|43 days (from baseline to Day 43)|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).||Participants|||Number
797346|NCT00931723|Primary|Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Final Assessment (Day 43)|The YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in manic symptoms. Total score ≤12 indicates remission (13-19=minimal symptoms; 20-25=mild mania, 26-37=moderate mania, 38-60=severe mania).|Change in YMRS total score from baseline to Day 43.|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).||Scores on a scale||Standard Error|Least Squares Mean
797347|NCT00931801|Secondary|Change in Quality of Life From Baseline to 48 Weeks of Study Treatment|Quality of Life was measured by self report using a standardized scale, where 0 is death and 100 is perfect health. The baseline measure was obtained prior to initiation of study treatment arm. The week 48 measure captures Quality of Life by self report at 48 weeks of study treatment.|baseline and 48 weeks|Data for all participants assigned to a study treatment was analyzed except data for participants that did not have both baseline and week 48 data, including early withdrawal, virologic failure, loss to follow-up or missing data.||units on a scale||Standard Deviation|Mean
797348|NCT00931801|Secondary|The Change in Adherence to Study Treatment Arm From Baseline to Week 48|Adherence to study treatment reported as the percentage of doses of the prescribed treatment arm regimen taken, described by each subject through recall of dosing in the three days prior to the visit Baseline and Week 48 vistis. The change in adherence is reflected as the difference of the mean percentage of adherence per arm between Baseline and Week 48 visits.|Baseline and Week 48|Values included for all enrolled participants excluding participants with confirmed virologic failure or those missing values due to early withdrawal, loss to follow-up or other error.||percentage of prescribed doses||Standard Deviation|Mean
797374|NCT00932022|Secondary|Percent Change From Baseline in Urgency Severity Associated With Toilet Voids|Due to lack of evaluable data, analysis for this outcome measure was not performed.|Baseline (Week 2), Week 14||||||
797350|NCT00931801|Primary|Maintenance of Virologic Suppression|To evaluate and compare maintenance of virologic suppression with raltegravir (RAL) 400mg 2x daily plus atazanavir (ATV) dosed either as ATV/ritonavir (RTV)300/100mg 1x daily or ATV 300mg 2x daily in subjects with virologic suppression on a standard regimen of ATV/RTV plus Truvada. Virologic suppression is defined as HIV RNA < 40 copies/mL.|48 weeks|All enrolled participants were included in this analysis of primary outcome measurement.||participants|||Number
797351|NCT00931879|Primary|Efficacy Measures Examining Increased Vascular Response to Ischemic Block and to Local Warming at the Dorsum of the Foot.||One Year|Measures of vascular response to ischemic block and local warming at the dorsum of the foot were not reliably collected for this assessment due to the difficulty of analysis and the inability to properly distinguish a vascular response in patients.|||||
797352|NCT00931879|Primary|Efficacy Measures Are Nerve Conduction Studies, Specifically Changes in F-wave Conduction||One Year|||m/s||Standard Error|Mean
797353|NCT00931879|Primary|Efficacy Measures Are Nerve Conduction Studies, Specifically Changes in Latency.||One Year|||ms||Standard Error|Mean
797354|NCT00931879|Primary|Efficacy Measures Are Nerve Conduction Studies; Specifically, Increases in Conduction Velocity.||One Year|||m/s||Standard Error|Mean
797355|NCT00931879|Primary|Measurements of Indices of Large and Small Fiber Nerve Function Including Markers of Inflammation and Oxidative Stress.|Oxidative stress/inflammatory markers (IL1β, IKKβ, TLR4, TNF-α, JNK1, toll-like receptor 2) were assessed through a meal challenge.|One year|||pg/ml||Standard Error|Mean
797356|NCT00931879|Primary|Percent Change in Measurements of Indices of Large and Small Fiber Nerve Function Including Vibration Thresholds|Quantitative Sensory Tests (QSTs), including vibration detection threshold, were used to evaluate peripheral sensory perception. Mean represents percent change of total group. Measurements taken at baseline and at one year.|One year|||% Change||Standard Error|Mean
797357|NCT00931879|Primary|Measurements of Indices of Large and Small Fiber Nerve Function Using Vibration and Thermal Thresholds.|Quantitative Sensory Tests (QSTs), including, cold sensation threshold, cold pain threshold and vibration detection threshold, were used to evaluate peripheral sensory perception.|One year|||°C||Standard Error|Mean
797358|NCT00931879|Primary|Measurements of Indices of Large and Small Fiber Nerve Function Including Heart Rate Variation Measures.|Quantitative Autonomic Function Tests (QAFTs) were performed. Primarily, power spectral analysis of heart rate variability (HRV) and time- and frequency-domain analyses, including measures of the sympathetic and parasympathetic control of the heart beat (R-R interval), were recorded with deep breathing, Valsalva, and standing from the sitting position maneuvers. Additionally, the sample difference of the beat to beat (NN) intervals and the TSP was calculated as well as the standard deviation of all normal R-R intervals (sdNN).|One year|||ms||Standard Error|Mean
797359|NCT00931879|Primary|Efficacy Measures Are Nerve Conduction Studies, Specifically Changes in Conduction Amplitude.|19 participants in each arm( placebo or omega-3-ethyl esters 4g) were analyzed . Conduction velocities and amplitude of the following nerves were compared between each arm: Tibial Nerve Ankle Amplitude, Tibial Nerve Popliteal Amplitude, Median Nerve Wrist Amplitude, Median Nerve Elbow Amplitude, Peroneal Motor Nerve Ankle Amplitude, Peroneal Motor Nerve Below Fibular Amplitude, Peroneal Motor Nerve Above Fibular Amplitude, Sensory Median Nerve Wrist Amplitude, Sensory Ulnar, Sensory Sural Ankle Ampltiude Wrist Ampltiude|One year|||uV||Standard Error|Mean
797360|NCT00931918|Secondary|Percentage of Participants With Chemistry and Hematology Laboratory Values Grade 3 or Higher|Percentage of participants who shifted from a National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade 0, 1, or 2 at Baseline to a Grade 3 or higher on study (worst post-baseline grade). Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe or medically significant but not immediately life-threatening, Grade 4=Life-threatening consequences and 5=Death related to AE.|Days 1, 4 and 10 of each cycle and end of treatment visit (Median of 16 weeks on treatment)|Safety Population included all randomized participants who received at least 1 dose of study drug.||percentage of participants|||Number
797361|NCT00931918|Secondary|Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) by Category|Percentage of participants in the following categories: • At least 1 TEAE • Drug-related, TEAEs • Grade 3 or higher TEAEs. Grade 3 are AEs of Severe Intensity • Grade 3 or higher drug-related, TEAEs • TEAEs resulting in study drug discontinuation • Serious TEAEs An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A Serious Adverse Event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.|First dose of study drug through 30 days after the last dose of study drug (Up to 26 Weeks)|Safety Population included all randomized participants who received at least 1 dose of study drug.||percentage of participants|||Number
797362|NCT00931918|Secondary|Time to Progression (TTP)|TTP is defined as the time from the date of randomization to the date of first documentation of progressive disease, relapse from CR, or death related to disease under study if participant did not have any documentation of disease progression prior to death caused by lymphoma or complications thereof. For a participant who has not progressed and is not known to have died due to disease under study at the end of his/her study follow-up or at the time of start of an alternate therapy (whichever is first), TTP is censored at the last overall response assessment that is stable disease or better, and which is prior to the start of the alternate therapy, if any. Disease response was assessed using International Working Group (IWG)-revised response criteria for malignant lymphoma. PD= any new lesion or increase by > 50% of previously involved sites from nadir.|Median Follow-up of 34.3 months for RCHOP arm and 34.4 months for Vc-RCHOP arm|MITT Population included all randomized participants who received study drug and who had a central laboratory-confirmed Non-Germinal Center B-Cell (non-GCB) subtype.||months||95% Confidence Interval|Median
797404|NCT00937950|Primary|Number of Subjects With Treatment Referrals by Treatment Type|Subjects who presented treatment referral, Loop excision of cervix, Loop cone of cervix, Cold knife cone of cervix, Laser excision, other.|At Month 48|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered and results available at each analysis timepoint.||Subjects|||Number
797363|NCT00931918|Secondary|Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) Negative Rate|FDG-PET negative rate is defined as the percentage of participants FDG-PET negative at the given time-point.|End of Cycle 2 and End of Treatment (Cycle 6) [Median of 16 weeks on treatment]|Response-Evaluable Population included all randomized participants who had at least 1 dose of study drug, who had a central laboratory-confirmed non-GCB subtype with measurable disease at Baseline and at least 1 post-baseline response assessment.||percentage of participants||95% Confidence Interval|Number
797364|NCT00931918|Secondary|Duration of Response|Duration of response is defined as the time (in months) from the date of first documentation of confirmed complete response (CR) or partial response (PR) to the date of first documentation of progressive disease (PD), relapse from CR or death related to disease. For a participant who has not progressed and is not known to have died due to disease under study at the end of his/her study follow-up or at the time of start of an alternate therapy (whichever is first), duration of response is censored at the last overall response assessment that is stable disease or better, and which is prior to the start of the alternate therapy, if any. Disease response was assessed using IWG-revised response criteria for malignant lymphoma. CR=Disappearance of all evidence of disease and PR=Regression of measurable disease and no new sites and PD= any new lesion or increase by > 50% of previously involved sites from nadir.|Median Follow-up of 34.3 months for RCHOP arm and 34.4 months for Vc-RCHOP arm|Participants from the Response-Evaluable Population included all randomized participants who had at least 1 dose of study drug, who had a central laboratory-confirmed non-GCB subtype with measurable disease at Baseline and at least 1 post-baseline response assessment who had a CR or PR||months||95% Confidence Interval|Median
797365|NCT00931918|Secondary|Complete Response Rate|Complete Response Rate is defined as the percentage of participants with the best response of Complete Response (CR). Disease response was assessed using International Working Group (IWG)-revised response criteria for malignant lymphoma. CR=Disappearance of all evidence of disease.|End of Cycle 2, End of Treatment (Cycle 6) [Median of 16 weeks on treatment]|Response-Evaluable Population included all randomized participants who had at least 1 dose of study drug, who had a central laboratory-confirmed non-GCB subtype with measurable disease at Baseline and at least 1 post-baseline response assessment.||percentage of participants||95% Confidence Interval|Number
797366|NCT00931918|Secondary|Overall Response Rate (ORR)|ORR is defined as the percentage of participants with the best overall response complete response (CR) + partial response (PR). Disease response was assessed using International Working Group (IWG)-revised response criteria for malignant lymphoma. CR=disappearance of all evidence of disease and PR=regression of measurable disease and no new sites.|End of Cycle 2, End of Treatment (Cycle 6) [Median of 16 weeks on treatment]|Response-Evaluable Population included all randomized participants who had at least 1 dose of study drug, who had a central laboratory-confirmed non-GCB subtype with measurable disease at Baseline and at least 1 post-baseline response assessment.||percentage of participants||95% Confidence Interval|Number
797367|NCT00931918|Secondary|Overall Survival|Overall survival is defined as the time from the date of randomization to the date of death from any cause. A participant who is alive at the end of his/her study follow-up is censored at the date of last contact.|Median Follow-up of 34.3 months for RCHOP arm and 34.4 months for Vc-RCHOP arm|MITT Population included all randomized participants who received study drug and who had a central laboratory-confirmed Non-Germinal Center B-Cell (non-GCB) subtype.||months||95% Confidence Interval|Median
797368|NCT00931918|Primary|Progression-Free Survival Rate|PFS is defined as the time in months from the date of randomization to the date of first documentation of progressive disease (PD) or death from any cause. The date of progression is the earliest date of a computed tomography/positron emission tomography (CT/PET) scan that shows evidence of PD. For a participant that has not progressed and is alive at the end of his/her study follow-up or at the time of start of an alternate therapy (whichever is first), PFS is censored at the last overall response assessment that is stable disease or better, and which is prior to the start of the alternate therapy, if any. Disease response was assessed using International Working Group (IWG)-revised response criteria for malignant lymphoma. PD= any new lesion or increase by > 50% of previously involved sites from nadir. The progression-free survival rate is defined as the Kaplan-Meier (KM) estimate of progression-free survival at 2 years.|2 Years (Median Follow-up of 34.3 months for RCHOP arm and 34.4 months for Vc-RCHOP arm)|Modified Intent-to-treat (mITT) Population included all randomized participants who received study drug and who had a central laboratory-confirmed Non-Germinal Center B-Cell (non-GCB) subtype.||percentage of participants|||Number
797369|NCT00931918|Primary|Progression-Free Survival (PFS) in Patients With Non-germinal Center B-cell-like (Non-GCB) Diffuse Large B-cell Lymphoma (DLBCL)|PFS is defined as the time in months from the date of randomization to the date of first documentation of progressive disease (PD) or death from any cause. The date of progression is the earliest date of a computed tomography/positron emission tomography (CT/PET) scan that shows evidence of PD. For a participant that has not progressed and is alive at the end of his/her study follow-up or at the time of start of an alternate therapy (whichever is first), PFS is censored at the last overall response assessment that is stable disease or better, and which is prior to the start of the alternate therapy, if any. Disease response was assessed using International Working Group (IWG)-revised response criteria for malignant lymphoma. PD= any new lesion or increase by > 50% of previously involved sites from nadir.|Median Follow-up of 34.3 months for RCHOP arm and 34.4 months for Vc-RCHOP arm|Modified Intent-to-treat (mITT) Population included all randomized participants who received study drug and who had a central laboratory-confirmed Non-Germinal Center B-Cell (non-GCB) subtype.||months||95% Confidence Interval|Median
797370|NCT00931996|Primary|Positive and Negative Syndrome Scale (PANSS) Score Change From Baseline.|Positive and Negative Syndrome Scale (PANSS) Total Score. 1 to 7 on 30 different symptoms based on the interview as well as reports of family members or primary care hospital workers. PANSS Total score minimum = 30, maximum = 210 Higher scores represent more severe symptoms. A positive change score (baseline-6 weeks) indicates an improvement in symptoms.|Baseline and 6 weeks|Completers||units on a scale||Standard Deviation|Mean
797371|NCT00932022|Secondary|Percent Change From Baseline in Percentage of Patients Continent|Due to lack of evaluable data, analysis for this outcome measure was not performed.|Baseline (Week 2), Week 14||||||
797372|NCT00932022|Secondary|Percent Change From Baseline in Over Active Bladder (OAB)-Symptom Composite Score|Due to lack of evaluable data, analysis for this outcome measure was not performed.|Baseline (Week 2), Week 14||||||
797373|NCT00932022|Secondary|Percent Change From Baseline in Voided Volume|Due to lack of evaluable data, analysis for this outcome measure was not performed.|Baseline (Week 2), Week 14||||||
797375|NCT00932022|Primary|Percent Change From Baseline in Urinary Urgency Incontinence (UUI)|Patients recorded information about UUI (accidental leakage, urgency associated with void and urgency severity) in a 3-day diary at Baseline (Week 2) and Week 14. The daily average episodes of UUI was the sum of all UUI episodes over valid diary days during the 3-day diary period divided by the valid number of diary days with at least one valid bladder entry. The percent change from baseline was calculated as (Mean UUI at Week 14- Mean UUI at Week 2)/ Mean UUI at Week 2 X 100. A negative number percent change from baseline indicated an improvement.|Baseline (Week 2), Week 14|Modified Intent-to-Treat (mITT) defined as all patients who were randomized and received at least one dose of study medication. Analysis below was done on patients from the mITT population who completed the study at Week 14 and who had data available for this outcome measure.||Percent change||Standard Deviation|Mean
797376|NCT00932035|Primary|Percentage of Patients With Lymphedema|Difference between arms in patients developing lymphedema at any point during the study will be evaluated using chi-squared tests.|Up to 4 years|Because of early termination the study did not accrue the planned number of subjects.||Participants|||Count of Participants
797377|NCT00932035|Primary|Percentage of Patients With Positive Axillary Reverse Mapping (ARM) Identified Nodes|A Fisher's exact test with a one-sided alpha of 0.05 will be used to determine if the percentage of patients with positive ARM identified nodes excised in the standard dissection group is superior to the experimental dissection group.|Up to 4 years|Because of early termination the study did not accrue the planned number of subjects.||Participants|||Count of Participants
797378|NCT00932035|Primary|Percentage of Patients With Arm Lymphatics Above, at, or Below the Axillary Vein|A Fisher's exact test with a one-sided alpha of 0.05 will be used to determine if the percentage of patients with arm lymphatics above, around, or below the axillary vein in the standard dissection group is superior to the experimental dissection group.|Up to 4 years|Because of early termination the study did not accrue the planned number of subjects.||Participants|||Count of Participants
797379|NCT00932113|Secondary|Clinical Endpoints for Psoriasis: Photography Completed||Week 0 and Week 16|||participants|||Number
797380|NCT00932113|Secondary|Clinical Endpoints for Psoriasis: Target Lesion Score|The lesion score of a single psoriatic plaque selected at baseline. Total range is 0 - 12 with 0 being clear and 12 representing the most severe disease. The target lesion score is composed of scale, erythema, and induration, each parameter is scored 0 (clear) through 4 (very severe). Totals are summed for target lesion score. S+E+I = TLS|Week 0 and Week 16|||units on a scale||Full Range|Mean
797381|NCT00932113|Secondary|Clinical Endpoints for Psoriasis: % Body Surface Area||Week 0 and week 16|||percentage of total body surface area||Full Range|Mean
797382|NCT00932113|Secondary|Clinical Endpoints for Psoriasis: Physician's Global Assessment (PGA) Clear or Almost Clear (PGA 0-1)||Week 0 and Week 16|||percentage of subjects|||Number
797383|NCT00932113|Other Pre-specified|Additional Gene Analysis (Ongoing)|A single, long-term follow-up visit will be done for all available subjects for additional pharmacogenetic analysis. The goal in collecting DNA from psoriasis patients is to determine if individual subjects have gene variants associated with increased incidence of psoriasis. The investigators plan on analyzing variants using single nucleotide polymorphism (SNP) analysis by high-throughput DNA sequencing. This patient genetic information may allow us to correctly interpret data collected about gene expression levels in affected or non-affected skin. Additionally genetic typing may lead to cogent personalized health care (PHC) strategies for the identification of psoriasis drug responders/non-responders, patients who achieve durable disease remission post-treatment, and/or pharmacodynamic markers, as examples.|long-term follow-up visit 4- 6 years post end of study||||||
797384|NCT00932113|Secondary|Clinical Endpoints for Psoriasis: PASI 75|PASI 75 is the percent of subjects who experience an improvement in PASI (Psoriasis Area and Severity Index) score of at least 75% from their baseline PASI score.|Weeks 0 and week 16|||percentage of subjects|||Number
797385|NCT00932113|Primary|Biologic Activity Endpoints|Histologic and Immunohistochemistry endpoints; Relative messenger RNA gene expression (normalized to HARP); and Gene Arrays.|Weeks 0, 1, 2, 4 and 16|||fold change||Standard Error|Mean
797386|NCT00932126|Secondary|Baseline Tumor Expression of PAK-related Pathway Molecules and Other Known Biomarkers||Baseline|Data not analyzed due to early study termination.|||||
797387|NCT00932126|Secondary|PAK (p21 Activated Kinase)-Related Pathway Molecule Expression Modulation by PF-03758309 in Tumor and Surrogate Tissue||Screening, 0, 2, 4, and 72 hours post dose Cycle 2 Day 8. A 6th sample of hair follicle could be requested at 6 or 8 hours post-dose if necessary. For fresh tumor tissue, baseline and between Day 8 and 22 of Cycle 1 in participants with accessible tumors|Data not analyzed due to early study termination.|||||
797388|NCT00932126|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)||predose, 0.5, 1, 2, 3, 5, 8, 10, 24 and 48 hours post dose, and on Cycle 1 Day 15 at predose, 0.5, 1, 2, 3, 5, 8 and 10 hours post morning dose|Data not analyzed due to early termination of the study.|||||
797389|NCT00932126|Secondary|Minimum Observed Plasma Trough Concentration (Cmin)||predose, 0.5, 1, 2, 3, 5, 8, 10, 24 and 48 hours post dose, and on Cycle 1 Day 15 at predose, 0.5, 1, 2, 3, 5, 8 and 10 hours post morning dose|Data not analyzed due to early termination of the study.|||||
797390|NCT00932126|Secondary|Area Under the Concentration-Time Curve From Time 0 to 12 Hours Post Morning Dose [AUC(0-12)]||pre-dose and 12 hours post morning dose|Data not analyzed due to early termination of the study.|||||
797391|NCT00932126|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|predose, 0.5, 1, 2, 3, 5, 8, 10, 24 and 48 hours post dose, on Cycle 1 Day 8 and Cycle 2-4 Day 1 at pre-dose and 2 hours post morning dose, and on Cycle 1 Day 15 at predose, 0.5, 1, 2, 3, 5, 8 and 10 hours post morning dose|Data not analyzed due to early termination of the study.|||||
797392|NCT00932126|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||predose, 0.5, 1, 2, 3, 5, 8, 10, 24 and 48 hours post dose, on Cycle 1 Day 8 and Cycle 2-4 Day 1 at pre-dose and 2 hours post morning dose, and on Cycle 1 Day 15 at predose, 0.5, 1, 2, 3, 5, 8 and 10 hours post morning dose|Data not analyzed due to early termination of the study.|||||
797393|NCT00932126|Secondary|Maximum Observed Plasma Concentration (Cmax)||predose, 0.5, 1, 2, 3, 5, 8, 10, 24 and 48 hours post dose, on Cycle 1 Day 8 and Cycle 2-4 Day 1 at pre-dose and 2 hours post morning dose, and on Cycle 1 Day 15 at predose, 0.5, 1, 2, 3, 5, 8 and 10 hours post morning dose|Data not analyzed due to early termination of the study.|||||
797394|NCT00932126|Secondary|Duration of Response|Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 2 months until when the last participant was discontinued due to disease progression in Month 27 of the study|Data not analyzed due to early termination of the study.|||||
797395|NCT00932126|Secondary|Time to Tumor Progression (TTP)|Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever comes first. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD])|Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 2 months until when the last participant was discontinued due to disease progression in Month 27 of the study|Data not analyzed due to early termination of the study.|||||
797396|NCT00932126|Secondary|Number of Participants With Objective Response|Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.|Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 2 months until when the last participant was discontinued due to disease progression in Month 27 of the study|Per protocol analysis set: all participants who have received a minimum of 1 cycle of study treatment (at least 80% of planned dose), had baseline assessments and at least 1 on-study tumor assessment were considered evaluable for response.||participants|||Number
797397|NCT00932126|Primary|Number of Participants With Cycle 1 Dose-limiting Toxicities (DLT)|DLT includes: Grade (GR) 4 neutropenia (NP) that persisted for >7 consecutive days; Febrile NP; GR3 NP infection; GR4 thrombocytopenia (TP); GR3 TP with bleeding; Any other GR>=3 toxicity not classified under Common Terminology Criteria for Adverse Events (CTCAE) blood or bone marrow (exception of nausea, vomiting, or diarrhea in subjects who received optimal treatment with antiemetics or anti-diarrheals); Failure to recover to an adequate condition to recommence study treatment after a 2-week delay; Failure to receive >= 80% of planned PF-03758309 dose due to study drug related toxicity|Baseline (up to 30 days prior to first study drug administration) till 28 days after the last treatment administration (end of Cycle 1 [28 days])|Safety analysis set: All participants enrolled in the study that received at least 1 dose of PF-03758309 (including the lead in dose).||participants|||Number
797402|NCT00937950|Primary|Number of Subjects With Any Fatal SAEs, With Any SAEs Assessed as Possibly Related to Study Participation or to a Concurrent GSK Medication.|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Up to Month 48|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered and results available at each analysis timepoint.||Subjects|||Number
797403|NCT00937950|Primary|Number of Subjects With AEs or SAEs Leading to Withdrawal|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|Up to Month 48|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered and results available at each analysis timepoint.||Subjects|||Number
797740|NCT00935220|Secondary|Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities|12-lead-Electrocardiogram (ECG), vital sign (blood pressure and pulse rate), physical finding and laboratory abnormalities|21 days|All treated patients||Participants|||Number
797405|NCT00937950|Primary|Number of Subjects With Treatment Referrals by Treatment Type|Subjects who presented treatment referral, Loop excision of cervix, Loop cone of cervix, Cold knife cone of cervix, Laser excision, other.|At Month 36|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered and results available at each analysis timepoint.||Subjects|||Number
797406|NCT00937950|Primary|Number of Subjects With Treatment Referrals by Treatment Type|Subjects who presented treatment referral, Loop excision of cervix, Loop cone of cervix, Cold knife cone of cervix, Laser excision, other.|At Month 24|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered and results available at each analysis timepoint.||Subjetcs|||Number
797407|NCT00937950|Primary|Number of Subjects With Treatment Referrals by Treatment Type|Subjects who presented treatment referral, Loop excision of cervix, Loop cone of cervix, Cold knife cone of cervix, Laser excision, other.|At Month 12|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered and results available at each analysis timepoint.||Subjects|||Number
797408|NCT00937950|Primary|Number of Subjects With Cervical Biopsy Results|Subjects with negative and positive cervical biopsy results for only CIN1, only CIN2, only CIN3, CIN1 and CIN2, CIN1 and CIN3, CIN2 and CIN3, CIN1 and CIN2 and CIN3, AIS, Invasive malignancy, other.|At Month 48|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered and results available at each analysis timepoint.||Subjects|||Number
797409|NCT00937950|Primary|Number of Subjects With Cervical Biopsy Results|Subjects with negative and positive cervical biopsy results for only CIN1, only CIN2, only CIN3, CIN1 and CIN2, CIN1 and CIN3, CIN2 and CIN3, CIN1 and CIN2 and CIN3, AIS, Invasive malignancy, other.|At Month 36|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered and results available at each analysis timepoint.||Subjects|||Number
797410|NCT00937950|Primary|Number of Subjects With Cervical Biopsy Results|Subjects with negative and positive cervical biopsy results for only CIN1, only CIN2, only CIN3, CIN1 and CIN2, CIN1 and CIN3, CIN2 and CIN3, CIN1 and CIN2 and CIN3, AIS, Invasive malignancy, other.|At Month 24|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered and results available at each analysis timepoint.||Subjects|||Number
797411|NCT00937950|Primary|Number of Subjects With Cervical Biopsy Results|Subjects with negative and positive cervical biopsy results for only CIN1, only CIN2, only CIN3, CIN1 and CIN2, CIN1 and CIN3, CIN2 and CIN3, CIN1 and CIN2 and CIN3, AIS, Invasive malignancy, other.|At Month 12|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered and results available at each analysis timepoint.||Subjects|||Number
797412|NCT00937950|Primary|Number of Subjects With Cervical Cytology|Subjects who presented normal, ASC-US (Atypical Squamous Cell of Undetermined Significance), LSIL (Low-grade Squamous Intraepithelial Lesions), HSIL (High-grade Squamous Intraepithelial Lesions), AGC (Atypical Glandular Cells), ASC-H (Atypical Squamous Cells cannot exclude HSIL) cervical cytology.|At Months 12, 24, 36, 48|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered and results available at each analysis timepoint.||Subjects|||Number
797413|NCT00937950|Primary|Number of Subjects With Colposcopy Referral and Colposcopy Adequacy|Subjects with colposcopy referral and colposcopy adequacy.|At Months 12, 24, 36, 48|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered and results available at each analysis timepoint.||Subjects|||Number
797414|NCT00937950|Primary|Number of Subjects With HPV DNA in Cervical Samples by HCII|Subjects that presented oncogenic HPV DNA in cervical samples by HPV DNA testing (Hybrid Capture® 2 test [HCII]).|At Months 12, 24, 36, 48|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered and results available at each analysis timepoint.||Subjects|||Number
797415|NCT00938015|Secondary|Quality of Life Assessed by Health Assessment Questionnaire (HAQ) For Poly-Articular Type Psoriatic Arthritis (PsA)|HAQ is a 20 item questionnaire to measure functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 items grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. Total score range 0-60, higher score indicating greater functional limitations.|Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78|Efficacy set included all the participants who signed ICF. ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies those participants who were evaluable for this measure at given time points.||Units on a scale||Standard Deviation|Mean
797416|NCT00938015|Secondary|Quality of Life Assessed by Numerical Rating Scale (NRS) For Oligo-Articular Type Psoriatic Arthritis (PsA) - Physician Evaluation|Quality of life for oligo-articular type arthritis was assessed on a 11-point NRS ranging from 1 (best health status) to 10 (worst health status). NRS for the most affected joint as per physician was evaluated.|Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78|Efficacy set included all the participants who signed ICF. ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies those participants who were evaluable for this measure at given time points.||Units on a scale||Standard Deviation|Mean
797417|NCT00938015|Secondary|Quality of Life Assessed by Numerical Rating Scale (NRS) For Oligo-Articular Type Psoriatic Arthritis (PsA) - Participant Evaluation|Quality of life for oligo-articular type arthritis was assessed on a 11-point Numerical Rating Scale (NRS) ranging from 1 (best health status) to 10 (worst health status). NRS for the most affected joint as per participant was evaluated.|Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78|Efficacy set included all the participants who signed ICF. ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies those participants who were evaluable for this measure at given time points.||Units on a scale||Standard Deviation|Mean
797469|NCT00941304|Secondary|Onset of Analgesia|Time to onset of analgesia defined as median time to perceptible pain relief if confirmed by experiencing meaningful pain relief from time of study drug administration.|8 hours|Analysis based on ITT population; all subjects who received study drug and provided at least 1 post-dose assessment.||hours||95% Confidence Interval|Median
797418|NCT00938015|Secondary|Number of Joints With Active Arthritis|Numbers of joints with active arthritis were defined as joints that were swollen or, in absence of swelling, joints with limited motion with pain and/or tenderness.|Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78|Efficacy set included all the participants who signed ICF. ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies those participants who were evaluable for this measure at given time points.||Joints||Standard Deviation|Mean
797419|NCT00938015|Secondary|Percentage of Participants With Psoriatic Arthritis (PsA) Receiving Enbrel Who Stayed on the Treatment||Baseline up to Month 78|Efficacy set included all the participants who signed ICF.||Percentage of participants|||Number
797420|NCT00938015|Secondary|Incidence of Adverse Events and Serious Adverse Events Per Participant-Year|Participant-Year estimated by calculating all of the years that participants in a study were followed (mean study drug exposure duration multiplied by safety set population). Incidence calculated as AEs or SAEs divided by Participant-Year multiplied by 100. Incidence of AEs and SAEs were broken down by each follow-up time period.|Baseline up to Month 6, 12, 18, 30, 42, 54, 66|Safety set included all the participants who signed ICF and had at least one dose of study medication and had follow-up data. ‘n’ signifies those participants who were evaluable for this measure at given time points.||Events per participant year|||Number
797421|NCT00938015|Secondary|Percentage of Participants With at Least 1 Adverse Event (AE) Per Year|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|Baseline up to Year 6|Safety set included all the participants who signed ICF and had at least one dose of study medication and had follow-up data. ‘n’ signifies those participants who were evaluable for this measure at given time points.||Percentage of participants|||Number
797422|NCT00938015|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 5 up to Year 6|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Year 5 up to Year 6|Safety set included all the participants who signed ICF and had at least one dose of study medication and had follow-up data. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||Percentage of participants|||Number
797423|NCT00938015|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 4 up to Year 5|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Year 4 up to Year 5|Safety set included all the participants who signed ICF and had at least one dose of study medication and had follow-up data. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||Percentage of participants|||Number
797424|NCT00938015|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 3 up to Year 4|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Year 3 up to Year 4|Safety set included all the participants who signed ICF and had at least one dose of study medication and had follow-up data. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||Percentage of participants|||Number
797425|NCT00938015|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 2 up to Year 3|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Year 2 up to Year 3|Safety set included all the participants who signed ICF and had at least one dose of study medication and had follow-up data. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||Percentage of participants|||Number
797426|NCT00938015|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 1 up to Year 2|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Year 1 up to Year 2|Safety set included all the participants who signed ICF and had at least one dose of study medication and had follow-up data. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||Percentage of participants|||Number
797427|NCT00938015|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Baseline up to Year 1|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to Year 1|Safety set included all the participants who signed informed consent form (ICF) and had at least one dose of study medication and had follow-up data.||Percentage of participants|||Number
797438|NCT00940875|Primary|PFS|The median time, in weeks, between randomization and PFS event. Participants without documented PD were censored at the date of last tumor assessment, the last date recorded in the drug log, or the last date of follow-up the participant was known to be progression free, whichever was last. Participants without a post-BL tumor assessment who were known to be alive were censored at the date of randomization. PFS was estimated by using Kaplan-Meier methodology.|BL, Day 22 of Cycles 2, 4, and 6 (28-day cycles), every 2 months thereafter until disease progression, participant withdrawal, or study termination (up to 2 years)|FAS||weeks||95% Confidence Interval|Median
797428|NCT00938041|Primary|Number of Participants With Any Serious Adverse Event (SAE) and Adverse Event (AE)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as those events that were fatal or immediately life-threatening, and those events that resulted in hospitalization; prolonged an existing hospitalization; or resulted in disability, congenital anomaly, or cancer. Refer to the general AE/SAE module for a complete list of all AEs and SAEs.|Every 6 months until disease progression, death, or for 2 years following the dosimetric dose, whichever occurred first (average of 80.2 months)|ITT-Exposed Population||Participants|||Number
797429|NCT00938041|Primary|Overall Survival|Time to death (overall survival) is defined as the time from the start of retreatment (i.e., the dosimetric dose) to the date of death from any cause.|Every 6 months until disease progression, death, or for 2 years following the dosimetric dose, whichever occurred first (average of 80.2 months)|ITT-Exposed Population. Participants who did not die were censored at the date of their last contact in the study.||Months||95% Confidence Interval|Median
797430|NCT00938041|Primary|Time to Treatment Failure|Time to treatment failure is defined as the time from the dosimetric dose to the first occurrence of treatment withdrawal, a decision to receive additional therapy, study withdrawal, disease progression, or death.|Every 6 months until disease progression, death, or for 2 years following the dosimetric dose, whichever occurred first (average of 80.2 months)|ITT-Exposed Population. Participants who withdrew from the study for reasons other than progression or death were censored at the date of study withdrawal. Participants who did not meet any of the criteria for treatment failure were censored at their date of last contact in the study.||Months||95% Confidence Interval|Median
797431|NCT00938041|Primary|Progression-free Survival|Progression-free survival (time to progression or death) is defined as the time from the start of retreatment (i.e., the dosimetric dose) to the first documented progression or death. Disease Progression (PD) is defined as a >=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be grater than 2 cm diameter by radiographic evaluation or grater than 1 cm diameter by physical examination.|Every 6 months until disease progression, death, or for 2 years following the dosimetric dose, whichever occurred first (average of 80.2 months)|ITT-Exposed Population. Participants who did not progress or die were censored at their date of last contact in the study.||Months||95% Confidence Interval|Median
797432|NCT00938041|Primary|Duration of Response for All Confirmed Responders (CR + CCR + PR)|For participants with CR, clinical CR (CCR), or partial response (PR), duration of response is defined as the time from the first documented response to the first documented progression. CCR is defined as the complete resolution of all disease-related symptoms, but residual foci, thought to be residual scar tissue, are present. Generally, an unchanging lesion <=2 centimeters (cm) in diameter by radiographic evaluation or <=1 cm in diameter by physical examination can be considered scar tissue. The extent of disease must be unchanged or decreased upon follow-up evaluations and, if unchanged or if further decreases for 6 months or longer are present, the participant will then be reclassified as a CR (complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease). PR is defined as a >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions, with no new lesions.|Every 6 months until disease progression, death, or for 2 years following the dosimetric dose, whichever occurred first (average of 80.2 months)|ITT-Exposed Population. Only those participants with a confirmed CR, CCR, or PR were analyzed.||Months||95% Confidence Interval|Median
797433|NCT00938041|Primary|Number of Participants With Complete Response and Confirmed Complete Response|Complete response (CR) is defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. Response is defined as the best response achieved at any evaluation. A confirmed response is defined as a response that was confirmed by two separate response evaluations occurring at least 4 weeks apart.|Every 6 months until disease progression, death, or for 2 years following the dosimetric dose, whichever occurred first (average of 80.2 months)|ITT-Exposed Population: all participants who received at least one dose of study drug||Participants|||Number
797434|NCT00940875|Secondary|Duration of Response|Duration of response was defined as the time between the first documentation of CR or PR (whichever status was recorded first as assessed by the RECIST V 1.0) until the date of documented disease progression or death. Participants with no documented disease progression or death after confirmed CR or PR were censored at the date of the last tumor assessment or last date of follow-up when the participant was known to be progression free, whichever was last.|BL, Days 1, 8, and 15 of Cycles 1-6 (28-day cycles), every 28 days thereafter until death, participant withdrawal, or study termination up to 2 years.|Data could not be summarized to be included in the data table because there are too few events to calculate a median and confidence intervals.|||||
797435|NCT00940875|Secondary|Overall Survival (OS)|OS was defined as the median time, in weeks, between randomization and death due to any cause. Participants without documented death were censored at the last date recorded in the drug log, or the last date of follow-up the participant was known to be alive, whichever was last. Participants without a post-BL assessment who were known to be alive were censored at the date of randomization. OS was estimated using Kaplan-Meier methodology.|BL, Days 1, 8, and 15 of Cycles 1-6 (28-day cycles), every 28 days thereafter until death, participant withdrawal, or study termination up to 2 years.|FAS||weeks||95% Confidence Interval|Median
797436|NCT00940875|Secondary|Percentage of Participants Who Died||BL, Days 1, 8, and 15 of Cycles 1-6 (28-day cycles), every 28 days thereafter until death, participant withdrawal, or study termination up to 2 years.|FAS||percentage of participants|||Number
797437|NCT00940875|Secondary|Percentage of Participants With Non-Progression at Weeks 8 and 16|Non-progression was defined as CR, PR, or stable disease according to RECIST V 1.0: for TLs, CR was defined as the disappearance of all TLs, PR was defined as at least a 30% decrease in the SLD of TLs taking as reference the BL SLD, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD recorded since the start of treatment. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels, and SD was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above the normal limits. The 95% CI for one-sample binomial was determined using the Pearson-Clopper method.|Weeks 8 and 16|FAS||percentage of participants||95% Confidence Interval|Number
797439|NCT00940875|Secondary|Percentage of Participants Who Achieved Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST V 1.0|As per RECIST V 1.0: for TLs, CR was defined as the disappearance of all TLs, and PR was defined as at least a 30% decrease in the SLD of TLs taking as reference the BL SLD. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. The 95% confidence interval (CI) for one-sample binomial was determined using the Pearson-Clopper Method.|BL, Day 22 of Cycle 2, 4, and 6 (28-day cycles), every 2 months thereafter until disease progression, participant withdrawal, or study termination (12 months after randomization of the last participant).|FAS||percentage of participants||95% Confidence Interval|Number
797440|NCT00940875|Primary|Percentage of Participants With Disease Progression or Death|Progression-free survival (PFS) was defined as the time from randomization to the date of first documentation of progressive disease (PD), according to Response Evaluation Criteria in Solid Tumors (RECIST) version (V) 1.0, or date of death from any cause. PD was defined for target lesions (TLs) as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded since the start of treatment, and for non-target lesions (NTLs) as unequivocal progression of NTLs. Participants without documented PD were censored at the date of last tumor assessment, the last date recorded in the drug log, or the last date of follow-up the participant was known to be progression free, whichever was last. Participants without a post-Baseline (BL) tumor assessment who were known to be alive were censored at the date of randomization.|BL, Day 22 of Cycles 2, 4, and 6 (28-day cycles), every 2 months thereafter until disease progression, participant withdrawal, or study termination (12 months after randomization of the last participant).|FAS||percentage of participants|||Number
797441|NCT00940888|Primary|Complication Free Survival Rate Related to the High Voltage RV SJ4 Lead or SJ4 Connector||5 years|||percentage of patients||90% Confidence Interval|Number
797442|NCT00940888|Primary|Right Ventricle (RV) Bipolar Capture Thresholds||5 years|Study participants with RV bipolar capture threshold at the 5 year follow up visit.||Volts||90% Confidence Interval|Mean
797443|NCT00940901|Primary|Greater Than or Equal to a 50% Reduction in Priapic Episodes|"A Priapism sexual activity log was administered to participants. In the log, participants were asked to quantify the number of priapic episodes they had experienced in the previous 2 weeks according to the following scale/tiers: 0 = no episodes, 1 = 1-2 episodes, 2 = 3-4 episodes, 3 = 5-8 episodes and 6 = greater than 20 episodes."|change between 8 weeks post intervention and 16 weeks post intervention|3 participants from the Phase 1 Sildenafil group were lost to follow up during the second phase; 2 individuals from the Phase 1 Placebo then sildenafil group were lost to follow up during the second phase.||Number of participants|||Number
797444|NCT00940901|Primary|Greater Than or Equal to a 50% Reduction in Priapic Episodes|"A Priapism sexual activity log was administered to participants. In the log, participants were asked to quantify the number of priapic episodes they had experienced in the previous 2 weeks according to the following scale/tiers: 0 = no episodes, 1 = 1-2 episodes, 2 = 3-4 episodes, 3 = 5-8 episodes and 6 = greater than 20 episodes."|change between baseline and 8 weeks post intervention|Intention to treat analysis.||Number of participants|||Number
797445|NCT00940927|Primary|Effect Maximum (Emax)|Maximum percentage of predicted FEV1 effect|15 minutes after each dose|||percentage of predicted|||Number
797446|NCT00940927|Primary|Effective Dose 50% (ED50)|ED50 is the cumulative dose of albuterol required to bring about 50% of maximum effect of albuterol|15 minutes after each dose|||ug|||Number
797447|NCT00940992|Primary|Change in Inflammatory Lesion Counts From Baseline|The LS mean changes from Baseline in inflammatory lesion count at Week 12.|Baseline to Week 12 / end of treatment|||Inflammatory lesions||95% Confidence Interval|Least Squares Mean
797448|NCT00940992|Primary|Investigator Global Assessment (IGA) Improvement From Baseline|The proportions of subjects with the primary measure of success at week 12 /end of study ,defined as a 2-grade improvement in the IGA (Investigator Global Assessment) relative to Baseline. The Investigator Global Assessment grades are: Grade 0 (Clear), Grade 1 (Almost Clear), Grade 2 (Mild), Grade 3 (Moderate) and Grade 4 (Severe).|Baseline to Week 12 / end of treatment|||percentage of subjects|||Number
797449|NCT00941031|Secondary|The Efficacy of Three Induction Regimens of AIN457 Administered Subcutaneously With Respect Participants Who Reported Either an IGA 0 or 1 After 12 Weeks of Treatment, Compared to Placebo|The investigator’s global assessment (IGA) was used to evaluate overall psoriatic disease, with scores ranging from 0 (clear) to 5 (very severe disease). Treatment success was defined as patients who achieved IGA 0 or 1 and improvement of at least 2 points on the IGA scale compared to baseline. The IGA rating score for involvement of hands and feet ranged from 0 (clear) to 4 (severe).|13 weeks|Full analysis set||Participants achieving goal|||Number
797450|NCT00941031|Secondary|The Efficacy of Two Maintenance Regimens of AIN457 With Respect to PASI 75 Achievement at Least Once From Week 21 to 29||week 21 to 29|(Full analysis set, LOCF)||Participants achieving goal|||Number
797451|NCT00941031|Primary|The Efficacy of Three Induction Regimens of AIN457 Administered Subcutaneously in Patients With Moderate to Severe Chronic Plaque-type Psoriasis With Respect to PASI 75 Achievement After 12 Weeks of Treatment, Compared to Placebo.|Number (%) of patients achieving PASI 50, PASI 75, PASI 90, by visit and induction treatment|13 weeks|(Full analysis set, LOCF) Number (%) of patients achieving PASI 50, PASI 75, PASI 90, by visit and induction treatment||Participants achieving goal|||Number
797452|NCT00941070|Post-Hoc|Progression Free Survival by Smoking Status|Percent of patients that were progression free by smoking status|at 18 months from study entry|||percentage of paticipants||95% Confidence Interval|Number
797453|NCT00941070|Secondary|Progression Free Survival by HPV Subtype|Tabular descriptive data will be presented. HPV sub-type will be associated with treatment related toxicity, clinical response, PET metabolic response, and overall clinical outcome. Kaplan-Meier (product-limit) method of survival estimation will be used. Tests of equivalence of the estimates will be compared using the Wilcoxon long-rank test using a threshold for statistical significance of P 0.05. Cox proportional hazards regression models will be used in multivariate analyses.|Baseline|||percentage of patients||95% Confidence Interval|Number
797454|NCT00941070|Secondary|Change in Smoking Behavior, Assessed Using the Smoking Questionnaire and Cessation Counseling||18 months from study entry|||participants|||Number
797455|NCT00941070|Secondary|Change in Sexual Function, Assessed Using the Sexual Function-Vaginal Changes Questionnaire||Baseline to up to 5 years||||||
797741|NCT00935220|Secondary|Treatment Emergent Adverse Events|Frequency of patients with AEs|21 days|All treated patients||Participants|||Number
797456|NCT00941070|Secondary|PET/CT Scan Metabolic Activity|Descriptive tabular data reporting mean, standard deviation, minimum, maximum provided by metabolic response cohort. Status of 3-month post-treatment metabolic response associated with clinical response measured by RECIST criteria and with overall clinical outcome. Kaplan-Meier (product-limit) method of survival estimation used. Tests of equivalence of the estimates compared using the Wilcoxon long-rank test using P 0.05. Cox proportional hazards regression models used in multivariate analyses.|Up to 5 years||||||
797457|NCT00941070|Secondary|PET/CT Scan Metabolic Activity|Descriptive tabular data reporting mean, standard deviation, minimum, maximum provided by metabolic response cohort. Status of 3-month post-treatment metabolic response associated with clinical response measured by RECIST criteria and with overall clinical outcome. Kaplan-Meier (product-limit) method of survival estimation used. Tests of equivalence of the estimates compared using the Wilcoxon long-rank test using P 0.05. Cox proportional hazards regression models used in multivariate analyses.|3 months post-treatment|Patients that completed 3-month 18F-FDG PET/CT||Standard Uptake Value (SUV)||Inter-Quartile Range|Median
797458|NCT00941070|Secondary|PET/CT Scan Metabolic Activity|Descriptive tabular data reporting mean, standard deviation, minimum, maximum provided by metabolic response cohort. Status of 3-month post-treatment metabolic response associated with clinical response measured by RECIST criteria and with overall clinical outcome. Kaplan-Meier (product-limit) method of survival estimation used. Tests of equivalence of the estimates compared using the Wilcoxon long-rank test using P 0.05. Cox proportional hazards regression models used in multivariate analyses.|Baseline (pre-therapy)|Patients that completed the 3-month 18F-FDG PET/CT||Standard Uptake Value (SUV)||Inter-Quartile Range|Median
797459|NCT00941070|Secondary|Progression-free Survival|Percentage of patients that did not have disease progression. Estimates of progression-free survival will be computed using the product-limit estimate of Kaplan and Meier.|at 18 months from study entry|Patients that completed the the 3-month 18F-FDG PET/CT.||percentage of patients||95% Confidence Interval|Number
797460|NCT00941070|Secondary|Percent of Patients With Incidence of Grade 2 or Higher Gastrointestinal and Genitourinary Toxicity, Assessed Using CTCAE v3.0 Until December 31, 2010 and CTCAE v4.0 Beginning January 1, 2011|Information will include the type, severity, time of onset, time of resolution, and the probable association with the study regimen. Frequency tables will be constructed to summarize observed incidence by severity and type of toxicity.|After 5 weeks of radiation therapy|All patients who receive at least one dose of Triapine® and cisplatin treatment.||percentage of patients|||Number
797461|NCT00941070|Secondary|Clinical and Objective Response Assignment|Number of patients with a complete clinical responses defined as disappearance of all target lesions. A complete metabolic response on PET/CT will be defined as absence of abnormal FDG uptake at sites of abnormal FDG uptake noted on pre-treatment FDG-PET study.|three month follow up assessment|Patients that completed the the 3-month 18F-FDG PET/CT. One patient died from an unrelated health event after completing radiation and experimental chemotherapy and was excluded from analyse.||participants|||Number
797462|NCT00941070|Secondary|Clinical and Objective Response Assignment|Number of patients with a complete clinical responses defined as disappearance of all target lesions. A complete metabolic response on PET/CT will be defined as absence of abnormal FDG uptake at sites of abnormal FDG uptake noted on pre-treatment FDG-PET study.|one month follow up assessment|Patients that completed the the 3-month 18F-FDG PET/CT. One patient died from an unrelated health event after completing radiation and experimental chemotherapy and was excluded from analyse.||participants|||Number
797463|NCT00941070|Secondary|Clinical and Objective Response Assignment|Number of patients with a complete clinical responses defined as disappearance of all target lesions. A complete metabolic response on PET/CT will be defined as absence of abnormal FDG uptake at sites of abnormal FDG uptake noted on pre-treatment FDG-PET study.|post therapy at 3 months|Patients that completed the 3-month F-18 FDG study.||participants|||Number
797464|NCT00941070|Primary|Fasting F-18 Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET/CT) Imaging Complete Metabolic Response, Reported Following National Cancer Institute (NCI) and European Organization for Research and Treatment of Cancer (EORTC) Guidelines.|To quantitate change in pre-treatment standard uptake value (SUV) on PET/CT and posttreatment PET/CT or disease progression PET/CT. Change in PET/CT SUV will be associated with 3-month best overall clinical response.|post therapy at 3 months|1 patient was non-compliant and received no therapy. Pt was excluded from analyses. 1 patient died from an unrelated health event after completing radiation and experimental chemotherapy and did not undergo 3-month F-18 FDG study.||Standard uptake value (SUV)||Inter-Quartile Range|Median
797465|NCT00941304|Secondary|Change From Baseline in Cognitive Assessment Using CNS-VS|"Cognition assessed using computer-based CNS Vital Signs® neurocognitive function test (CNS-VS), including symbol digit coding, Stroop test, and shifting attention test to measure cognitive flexibility, executive functioning, processing speed, and reaction time(*). Scores are computed from raw score calculations using the data values of individual subtests. An asterisk denotes that lower score is better”, otherwise higher scores are better."|Baseline (screening), 2 hours 15 minutes postdose|Analysis based on ITT population; all subjects who received study drug and provided at least 1 post-dose assessment.||Score||Standard Deviation|Mean
797466|NCT00941304|Secondary|Percentage of Participants With “Excellent” Investigator Global Rating of Study Drug|Investigators rated the global effectiveness of study drug as poor, fair, good, or excellent, in response to “Overall, how would you rate the study medication for this subject?”|24 hours|Analysis based on ITT population; all subjects who received study drug and provided at least 1 post-dose assessment.||percentage of participants|||Number
797467|NCT00941304|Secondary|Percentage of Participants Reporting a Global Rating of Study Drug as “Excellent”|Subjects rated the global effectiveness of study drug as poor, fair, good, or excellent, in response to “Overall, how would you rate the study medication you received for pain?”|8 hours and 24 hours|Analysis based on ITT population; all subjects who received study drug and provided at least 1 post-dose assessment.||percentage of participants|||Number
797468|NCT00941304|Secondary|Duration of Analgesia|Duration of analgesia was the median time to use of rescue medication; earliest concomitant medication start time for medications identified as rescue medications from time of study drug administration.|24 hours|Analysis based on ITT population; all subjects who received study drug and provided at least 1 post-dose assessment.||hours||95% Confidence Interval|Median
797482|NCT00941655|Secondary|Median Duration of Cytoreduction Surgery and Heated Intraperitoneal Chemotherapy (HIPEC)|Time it takes to perform this complex surgery and HIPEC to reduce tumor burden overall in this disease.|up to 12 hours|||hours||Full Range|Median
797470|NCT00941304|Secondary|Peak Pain Relief|Maximum pain relief (PAR) at any time following dosing, recorded using a 5-point categorical rating scale, where 0=none, 1=a little, 2=some, 3=a lot, and 4=complete, in response to “How much relief have you had from your starting pain?”|24 hours|Analysis based on ITT population; all subjects who received study drug and provided at least 1 post-dose assessment.||units on a scale||Standard Deviation|Mean
797471|NCT00941304|Secondary|Peak Pain Intensity Difference|The maximum PID at any time following dosing determined from the change from baseline pain intensity assessment. Pain intensity was recorded using an 11-point NRS, where 0=none and 10=worst pain imaginable, in response to “What is your pain level at this time?”|24 hours|Analysis based on ITT population; all subjects who received study drug and provided at least 1 post-dose assessment.||units on a scale||Standard Deviation|Mean
797472|NCT00941304|Secondary|Sum of Pain Relief and Intensity Differences Over 2 Hours|Time-weighted sum of PAR and PID over 2 hours (SPRID-2) where total score ranges from 0 (worst) to 8 (best) and higher values indicate greater pain relief. PAR was recorded using a 5-point categorical rating scale, where 0=none, 1=a little, 2=some, 3=a lot, and 4=complete, in response to “How much relief have you had from your starting pain?” PID determined as the change from baseline pain intensity assessment. Pain intensity was recorded using an 11-point NRS, where 0=none and 10=worst pain imaginable, in response to “What is your pain level at this time?”|2 hours|Analysis based on ITT population; all subjects who received study drug and provided at least 1 post-dose assessment.||units on a scale||Standard Deviation|Mean
797473|NCT00941304|Secondary|Sum of Pain Relief and Intensity Differences Over 8 Hours|Time-weighted sum of PAR and pain intensity difference (PID) over 8 hours (SPRID-8) where total score ranges from -80 (worst) to 112 (best) and higher values indicate greater pain relief. PAR was recorded using a 5-point categorical rating scale, where 0=none, 1=a little, 2=some, 3=a lot, and 4=complete, in response to “How much relief have you had from your starting pain?” PID determined as the change from baseline pain intensity assessment. Pain intensity was recorded using an 11-point NRS, where 0=none and 10=worst pain imaginable, in response to “What is your pain level at this time?”|8 hours|Analysis based on ITT population; all subjects who received study drug and provided at least 1 post-dose assessment.||units on a scale||Standard Deviation|Mean
797474|NCT00941304|Secondary|Total Pain Relief Over 8 Hours|Time-weighted sum of total pain relief over 8 hours (TOPAR-8) where total score ranges from 0 (worst) to 32 (best) and higher values indicate greater pain relief. Pain relief (PAR) was recorded using a 5-point categorical rating scale, where 0=none, 1=a little, 2=some, 3=a lot, and 4=complete, in response to “How much relief have you had from your starting pain?”|8 hours|Analysis based on ITT population; all subjects who received study drug and provided at least 1 post-dose assessment.||units on a scale||Standard Deviation|Mean
797475|NCT00941304|Primary|Sum of Pain Intensity Difference From Baseline to 8 Hours|Time-weighted sum of pain intensity difference from baseline to 8 hours (SPID-8) where total score ranges from -80 (worst) to 80 (best) and a higher value indicates greater pain relief. Pain intensity was recorded using an 11-point numeric rating scale (NRS), where 0=none and 10=worst pain imaginable, in response to “What is your pain level at this time?”|Baseline, 8 hours|Analysis based on intent-to-treat (ITT) population; all subjects who received study drug and provided at least 1 post-dose assessment.||units on a scale||Standard Deviation|Mean
797478|NCT00941603|Secondary|Change From Baseline in Direct Non-HDL-C at Week 8|The percentage change from baseline in the participants' non-HDL-C was to be evaluated at study Week 8. Standard error presented below is least squares standard error.|Baseline and Week 8|Intent-to-treat population defined as all participants who receive randomized treatment assignment and have a baseline and at least one post-baseline non-HDL-C determination.||Percent change||Standard Error|Least Squares Mean
797479|NCT00941603|Primary|Change From Baseline in Direct LDL-C at Week 8|The percentage change from baseline in the participants' LDL-C was to be evaluated at study Week 8. Standard error presented below is least squares standard error.|Baseline and Week 8|Intent-to-treat population defined as all participants who receive randomized treatment assignment, and have a baseline and at least one post-baseline LDL-C determination.||Percent change||Standard Error|Least Squares Mean
797480|NCT00941655|Secondary|Patterns of Disease Recurrence Between the Two Therapeutic Approaches and Their Clinical Implications|Compare surgery + heated intraperitoneal chemotherapy + systemic chemotherapy; and systemic chemotherapy alone to determine how each group responds clinically.|up to 3 years|Zero participants were analyzed because data collected was insufficient due to the small sample size (I.e. too few patients to analyze) to make any comparisons that might be interpretable and subject to statistical rigor. Outcome will not be explored further.|||||
797481|NCT00941655|Secondary|Quality of Life (QOL) Parameters Between the Two Study Groups|QOL tools Functional Assessment of Cancer Therapy - Gastric cancer (FACT-Ga) specifically developed for the assessment of QOL in gastric cancer patients.|up to 3 years|Zero participants were analyzed because data collected was insufficient due to the small sample size (I.e. too few patients to analyze) to make any comparisons that might be interpretable and subject to statistical rigor. Outcome will not be explored further.|||||
797485|NCT00941655|Secondary|Completeness of Cytoreduction (CCR) Score|CCR is assessed by Sugarbaker's criteria. CCR-0 is no residual tumor. CCR-1 is no residual nodules greater than 2.5 mm in diameter, CCR-2 is no residual nodules greater than 25 mm, and CCR-3 is residual nodules greater than 25 mm.|Day 1|||Scores on a scale|||Number
797486|NCT00941655|Secondary|Gillys Stage Before and After Surgery|Gillys stage measures the completeness of the cytoreduction and is recorded before and after surgery. It is used to classify disease burden and determine prognosis. Stage 0 is no macroscopic signs of disease, stage 1 is nodules >5mm in one part of the abdomen, stage 2 is nodules >5 mm throughout the abdomen, stage 3 is nodules 5mm to 2 cm, and stage 4 is nodules < 2 cm.|Day 1|||Stage|||Number
797487|NCT00941655|Secondary|12 Months Disease Free Survival (DFS)|Participants who were alive and disease free at 12 months. DFS was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response was disappearance of all target lesions. Partial response was at least a 30% decrease in target lesions. Progression was at least a 20% increase in target lesions and stable disease is neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease.|12 months|||Participants|||Count of Participants
797488|NCT00941655|Secondary|Count of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|40.5 months|||Participants|||Count of Participants
797489|NCT00941655|Primary|Overall Survival in Patients With Limited Metastatic Gastric Carcinoma: Arm II|Time between the first day of treatment and the date of death|12 weeks up to 3 years|Patient #3 - alive 17 months at time of study closure; patient 5 alive 6 months at time of study closure; patient 13 alive 8 months at time of study closure; patients 10,12 randomized but withdrew/no treatment; patient 14 randomized but did not return for treatment and lost to follow up. Patient #16 was lost to follow up after being randomized.||Months|||Number
797490|NCT00941655|Primary|Overall Survival in Patients With Limited Metastatic Gastric Carcinoma: Arm I|Time between the first day of treatment and the date of death.|12 weeks up to 3 years|Patient #7 - alive 14 months at time of study closure; patient 11 alive 12 months at time of study closure; patient 15 expired following surgery.||Months|||Number
797491|NCT00941668|Primary|Level of Gingival Crevicular Fluid Interleukin - 6(GCF IL-6) at 2 Hours|Levels of Gingival crevicular fluid Interleukin - 6 (GCF IL-6) (weight in micrograms)|4 weeks|||Micrograms||Standard Deviation|Mean
797492|NCT00941668|Primary|Level of Gingival Crevicular Fluid Interleukin - 1 (GCF IL-1) at 2 Hours|Levels of Gingival crevicular fluid Interleukin - 1 (GCF IL-1)(weight in micrograms)|4 weeks|||Micrograms||Standard Deviation|Mean
797493|NCT00941681|Primary|AUC (Day 10)|Area under the curve (AUC) measured in hours * nanograms per milliliter (hr*ng/mL) post dose on day 10. Only one dose was administered on day 10 (final dose of study).|1 day|PK population (4 patients excluded from cohort 3 analysis due to improper dosing and 1 patient excluded from cohort 2 due to sudden death).||hr*ng/mL||Standard Deviation|Mean
797494|NCT00941681|Primary|T Max (Day 10)|Time of observed maximum plasma concentration (T max) measured in hours (hr) post dose on day 10. Only one dose was administered on day 10 (final dose of study).|1 day|PK population (4 patients excluded from cohort 3 analysis due to improper dosing and 1 patient excluded from cohort 2 due to sudden death).||hr||Standard Deviation|Mean
797495|NCT00941681|Primary|C Max (Day 10)|Maximum plasma concentration (C max) measured in nanograms per milliliter (ng/mL) post dose on day 10. Only one dose was administered on day 10 (final dose of study).|1 day|PK population (4 patients excluded from cohort 3 analysis due to improper dosing and 1 patient excluded from cohort 2 due to sudden death).||ng/mL||Standard Deviation|Mean
797496|NCT00941681|Primary|AUC (Day 1, Dose 1)|Area under the curve (AUC) measured in hours * nanograms per milliliter (hr*ng/mL) post first dose and pre second dose on day 1. Doses are approximately 12 hours apart in cohort 1 and 3 and 8 hours apart in cohort 2.|1 day|PK population (4 patients excluded from cohort 3 analysis due to improper dosing).||hr*ng/mL||Standard Deviation|Mean
797497|NCT00941681|Primary|T Max (Day 1, Dose 1)|Time of observed maximum plasma concentration (T max) measured in hours (hr) post first dose and pre second dose on day 1. Doses are approximately 12 hours apart in cohort 1 and 3 and 8 hours apart in cohort 2.|1 day|PK population (4 patients excluded from cohort 3 analysis due to improper dosing).||hr||Standard Deviation|Mean
797498|NCT00941681|Secondary|Evaluate the Safety and Tolerability of Oral Formulations of CK-1827452 When Dosed to Steady-state in Patients With Stable Heart Failure.||1 week||||||
797499|NCT00941681|Primary|C Max (Day 1, Dose 1)|Maximum plasma concentration (C max) measured in nanograms per milliliter (ng/mL) post first dose and pre second dose on day 1. Doses are approximately 12 hours apart in cohort 1 and 3 and 8 hours apart in cohort 2.|1 day|PK population (4 patients excluded from cohort 3 analysis due to improper dosing).||ng/mL||Standard Deviation|Mean
797500|NCT00941720|Secondary|Pulmonary Toxicity|Toxicity criteria will be assessed and graded according to the National Cancer Institute (NCI) Common Terminology Criteria (CTC) v3.0. Estimated using exact 95% binomial confidence intervals.|At 6 months|||percentage of participants||95% Confidence Interval|Number
797501|NCT00941720|Primary|Overall Survival|Number of patients alive at the end of the study period|at 6 months|||participants|||Number
797502|NCT00941720|Primary|Relapse-free Survival|Number of participants without progressive disease at the end of the study period, using the definitions for complete response, partial response and progressive disease from the International Myeloma Working Group .|at 6 months|||participants|||Number
797503|NCT00941733|Secondary|Improvement % Diameter Stenosis (%DS) of the Target Leasion (TL) Assessed by Quantitative Vascular Angiography (QVA)|Percentage of participants with an improvement in percent diameter stenosis (%DS) of the target leasion (TL) assessed by Quantitative Vascular Angiography (QVA)|12 months|Angiographic subgroup only. Angio-target lesion is one identifiable single solitary or series of multiple adjacent lesions with a diameter stenosis higher than 70% and a cumulative length less than 100 mm that can be covered by a single IN.PACT Amphirion™; and Angio-target lesion is the only lesion in that vessel.||percentage of participants analyzed|||Number
797504|NCT00941733|Secondary|Days of Hospitalization|Days of hospitalization at 1 year|12 months|All randomized subjects with available data||days||Standard Deviation|Mean
797505|NCT00941733|Secondary|Procedural Success|Percentage of patients with a procedural success defined as combination of technical success, device success and absence of procedural complications|Day 1|All randomized subjects with available data||percentage of participants analyzed|||Number
797506|NCT00941733|Secondary|Technical Success|Percentage of technical success defined as successful vascular access and completion of the endovascular procedure and immediate morphological success with less or equal to 50% residual diameter reduction of the treated lesion on completion angiography|Day 1|Number of device deployments||percentage of device deployments|||Number
797507|NCT00941733|Secondary|Device Success|Percentage of device success defined as exact deployment of the device according to the instructions for use as documented with suitable imaging modalities|Day 1|Number of device deployments||percentage of device deployments|||Number
797508|NCT00941733|Secondary|MAE (Major Adverse Events)|Percentage of participants with a MAE (Major Adverse Events) at 1 year. Major Adverse Events, defined as Death of any Cause, Major Amputation of target limb, Minor Amputation of target limb|12 months|Percentage based on number of evaluable subjects for safety events (227 participants in the drug eluting balloon arm and 111 patients in the Standard PTA arm). All randomized subjects experiencing at least one component for the safety endpoint or with follow-up of at least 330 days post-procedure.||percentage of participants analyzed|||Number
797509|NCT00941733|Secondary|Walking Capacity Assessment|"Walking Impairment assessment by WIQ at 1 year compared to baseline. The Walking Impairment Questionnaire (WIQ) is a questionnaire for evaluating walking impairment in patients with peripheral arterial disease (PAD). This can be used to identify patients with significant impairment and to monitor effectiveness of therapeutic interventions. The questionnaire was self-administered by the patients and contains three domains measuring three important factors of walking impairment in patients with intermittent claudication: (1) difficulty walking a distance during the past month, (2) difficulty walking at a certain speed during the past month, (3) symptoms associated with walking impairment. For each separate domain, a subscore was calculated. The total WIQ score was defined as the mean of the three subscores.
A WIQ score of 42.5 or less identified low performers; while a score of 75.5 or more identified high performers. The WIQ score range is 0 (minimum) – 100 (maximum)."|12 months|Effectiveness Analysis sets – all randomized subjects with available data for Walking Impairment assessment at baseline and 1 year||units on a scale||Standard Deviation|Mean
797510|NCT00941733|Secondary|Quality of Life Assessment by EQ5D|"Quality of life assessment by EQ5D at 1 year compared to baseline. EQ-5D is a standardised measure of health status and economic appraisal. The EQ-5D-3L essentially consists of 2 parts:the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: (1) no problems, (2) some problems, (3) extreme problems. The EQ VAS records the respondent’s self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'.
EQ-5D health states can be converted into a single summary index where 0.0='worst possible outcome' and 1.0='best possible outcome'."|12 months|Effectiveness Analysis sets – all randomized subjects with available data for EQ5D at baseline and 1 year||units on a scale||Standard Deviation|Mean
797511|NCT00941733|Secondary|Secondary Sustained Clinical Improvement|Percentage of participants that experienced a secondary sustained clinical improvement, specified as an improvement shift in the Rutherford classification of one class including the need for clinically driven TLR in amputation free surviving subjects at 1 year.|12 months|Analysis population consists of amputation free, clinically driven (target lesion revascularization)TLR free surviving subjects||percentage of participants analyzed|||Number
797512|NCT00941733|Secondary|Primary Sustained Clinical Improvement|Percentage of participants that experienced primary sustained clinical improvement at 1 year, specified as an improvement shift in the Rutherford classification of one class in amputation free, clinically driven target lesion revascularization (TLR) free surviving subjects.|12 months|Analysis population consists of amputation free, clinically driven (target lesion revascularization)TLR free surviving subjects||percentage of participants analyzed|||Number
797513|NCT00941733|Secondary|Death, Amputation and Clinically Driven Target Lesion Revascularization (TLR)|Percentage of participants that experienced death, amputation and clinically driven Target Lesion Revascularization (TLR) at 1 year.|12 months|Percentage based on number of evaluable subjects for safety events (227 participants in the drug eluting balloon arm and 111 patients in the Standard PTA arm). All randomized subjects experiencing at least one component for the safety endpoint or with follow-up of at least 330 days post-procedure.||percentage of participants analyzed|||Number
797514|NCT00941733|Secondary|Amputation Free Survival and Resolved Critical Limb Ischemia (CLI)|Percentage of participants with an amputation free survival and resolved Critical Limb Ischemia (CLI) at 1 year.|12 months|Percentage based on number of evaluable subjects for safety events (205 participants in the drug eluting balloon arm and 103 patients in the Standard PTA arm). All randomized subjects experiencing at least one component for the safety endpoint or with follow-up of at least 330 days post-procedure.||percentage of participants analyzed|||Number
797515|NCT00941733|Secondary|Amputation Free Survival and Wound Healing|Percentage of participants with a 1 year amputation free survival and wound healing. Wound healing is defined as core lab adjudication of > 50% area/volume reduction of baseline ulcer(s) in the treated leg at a specified time point.|12 months|Percentage based on number of evaluable subjects for safety events (206 participants in the drug eluting balloon arm and 103 patients in the Standard PTA arm). All randomized subjects experiencing at least one component for the safety endpoint or with follow-up of at least 330 days post-procedure.||percentage of participants analyzed|||Number
797516|NCT00941733|Secondary|Rate of Wound Healing|Percentage of participants with completed wound healing, wound healing as defined as core lab adjudication of > 50% area/volume reduction of baseline ulcer(s) in the treated leg at 1 year.|12 months|Patients with pre-existing wounds and/or occurence of new wounds||percentage of patients analyzed|||Number
797517|NCT00941733|Secondary|Amputation Free Survival|Percentage of participants with a 1 year amputation free survival.|12 months|Percentage based on number of evaluable subjects for safety events (227 participants in the drug eluting balloon arm and 111 patients in the Standard PTA arm). All randomized subjects experiencing at least one component for the safety endpoint or with follow-up of at least 330 days post-procedure.||percentage of participants analyzed|||Number
797557|NCT00942175|Primary|Pharmacodynamic Parameter MPA From Aggregometry (Turbidimetric) With 20 µM Adenosine Diphosphate.|MPA from aggregometry (turbidimetric) with 20 µM adenosine diphosphate.|24-hour post Day 9 dose in each period.|All participants who had valid parameter estimates for both formulations within PPI groups were included in the PK and PD statistical analyses for those parameters.||percentage of MPA||Standard Deviation|Mean
797518|NCT00941733|Primary|Composite of All Cause Death, Major Amputation and Clinically Driven Target Lesion Revascularization (CD-TLR)|Percentage of participants experiencing all cause death, major amputation and clinically driven Target Lesion Revascularization (CD-TLR) at 6 months. CD-TLR defined as any TLR of the target lesion associated with Deterioration of Rutherford Class and / or increase in size of pre-existing wounds and / or occurrence of a new wound(s)|6 months|Percentage based on number of evaluable subjects for safety events (232 participants in the drug eluting balloon arm and 114 patients in the Standard PTA arm). All randomized subjects experiencing at least one component for the safety endpoint or with follow-up of at least 330 days post-procedure.||percentage of participants analyzed|||Number
797519|NCT00941733|Primary|Clinically Driven Target Lesion Revascularization (TLR) of the Target Lesion in the Amputation Free Surviving Patients|Percentage of participants in the amputation free survival population with Clinically driven Target Lesion Revascularization (CD-TLR) at 12 months, CD-TLR defined as any TLR of the target lesion associated with Deterioration of Rutherford Class and / or increase in size of pre-existing wounds and / or occurrence of a new wound(s).|12 months|Amputation free surviving meaning participants without an amputation at 12 months. This analysis population consists of 196 participants in the Drug Eluting Balloon arm and 107 participants in the Standard PTA arm.||percentage of participants analyzed|||Number
797520|NCT00941733|Primary|Late Lumen Loss (LLL) of the Target Lesion by Quantitative Vascular Angiography (QVA)|The difference between minimum lumen diameter (MLD) immediately after Percutaneous Transluminal Angioplasty (PTA) and MLD at 12 months follow-up|12 months or at Target Lesion Revascularization (TLR) time|ITT||mm||Standard Deviation|Mean
797521|NCT00941798|Secondary|Change From Baseline in Asthma Control Questionnaire (ACQ) at Final Visit|"The Asthma Control Questionnaire score ranges from 0 (good control of asthma) to 6 (poor control of asthma). A negative change in score indicates improvement in asthma control.
Repeated measures of analysis of covariance model: change from baseline in ACQ score = treatment + visit + treatment*visit interaction + baseline ACQ score + region + asthma related hospitalization in the last 12 months + asthma worsening in the last 12 months + African American patient."|Baseline to the end of treatment (varying durations, up to 21 months)|Full analysis set: all randomized patients who received at least one dose of study medication. Participants with observations at both baseline and final visit were included in this analysis.||units on a scale||Standard Error|Least Squares Mean
797522|NCT00941798|Secondary|Change From Baseline in Percentage of Days With no Rescue Medication Use During 24 Hours, Daytime and Nighttime|24 hours consists of both 12 hour daytime and 12 hour nighttime. Baseline = the last 14 days prior to start of treatment. Analysis of covariance model: Change from baseline = treatment + baseline value + region + history of asthma related hospitalization in past 12 months + history of asthma worsening in past 12 months + African American patient.|Baseline to the end of treatment (varying durations, up to 21 months)|Full analysis set: all randomized patients who received at least one dose of study medication. Participants with observations at both baseline and final visit were included in this analysis.||percentage of days||Standard Error|Least Squares Mean
797523|NCT00941798|Secondary|Change From Baseline in Average Asthma Symptom Score Total, Daytime and Nighttime|"Total asthma symptom score = morning symptoms (0, 1) + daytime score (0-4) + nighttime score (0-4). The range is from 0 to 9. A lower number indicates improvement. Baseline = the last 14 days prior to start of treatment.
Analysis of covariance model: Change from baseline = treatment + baseline value + region + history of asthma related hospitalization in past 12 months + history of asthma worsening in past 12 months + African American patient."|Baseline to the end of treatment (varying durations, up to 21 months)|Full analysis set: all randomized patients who received at least one dose of study medication. Participants with observations at both baseline and endpoint were included in this analysis.||units on a scale||Standard Error|Least Squares Mean
797524|NCT00941798|Secondary|Change From Baseline in Percentage of Days With no Asthma Symptoms During the Morning, Daytime and Nighttime|Baseline = the last 14 days prior to start of treatment. Analysis of covariance model: Change from baseline = treatment + baseline value + region + history of asthma related hospitalization in past 12 months + history of asthma worsening in past 12 months + African American patient.|Baseline to the end of treatment (varying durations, up to 21 months)|Full analysis set: all randomized patients who received at least one dose of study medication. Participants with observations at both baseline and final visit were included in this analysis.||percentage of days||Standard Error|Least Squares Mean
797525|NCT00941798|Secondary|Changes From Baseline in Morning Peak Expiratory Flow (PEF) and Trough Evening PEF Averaged Over the Entire Post-baseline Period|"PEF was performed every morning and evening prior to study medication use except evenings on the day of clinic visits.
Baseline is average over the last 14 days prior to start of treatment. Analysis of covariance model: change from baseline in PEF = treatment + baseline PEF + region + history of asthma related hospitalization in the past 12 months + history of asthma worsening in the past 12 months + African American patient."|Baseline to the end of treatment (varying durations, up to 21 months)|Full analysis set: all randomized patients who received at least one dose of study medication. Participants with observations at both baseline and at final visit were included in this analysis.||liters per second||Standard Error|Least Squares Mean
797526|NCT00941798|Secondary|Change From Baseline in Forced Vital Capacity (FVC) at Final Visit|Spirometry was conducted according to internationally accepted standards. Change from baseline at final visit. FVC data taken within 6 hours of rescue medication was excluded from the analysis. Repeated measures of analysis of covariance model: change from baseline to final visit FVC = treatment + visit + treatment*visit interaction + baseline FVC + region + asthma related hospitalization in the last 12 months + asthma worsening in the last 12 months + African American patient.|Baseline to the end of treatment (varying durations, up to 21 months). At the following timepoints: 5 minutes post-dose, 30 minutes post-dose, 1 hour post-dose and 2 hours post-dose|Full analysis set: all randomized patients who received at least one dose of study medication. Participants with observations at both baseline and final visit were included in this analysis.||liter||Standard Error|Least Squares Mean
797554|NCT00942084|Primary|Clearance (CL)|"Timeframe:
Version 1:0-5 min,2-4 hrs,6-8 hrs post doses 1 and 5-15; prior to doses 5-15 Version 2:0-15 min post doses 1 and 5-15; within 30 min prior to doses 2 and 5-15; 2-3 hrs post doses 5-15; 15-18 hrs post last dose"|V1:0-5 min,2-4 hrs,6-8 hrs post Doses 1&5-15;prior to doses 5-15; V2:0-15 min post doses 1&5-15; within 30 min prior to doses 2&5-15; 2-3 hrs post doses 5-15; 15-18 hrs post last dose|32 infants enrolled. 2 infants died. 2 infants did not contribute PK samples to the analysis. 28 contributed PK samples to the final analysis.||L/h/kg||Full Range|Median
797527|NCT00941798|Secondary|Change From Baseline in Forced Expiration Volume in 1 Second (FEV1) at Final Visit|Spirometry was conducted according to internationally accepted standards. Change from baseline at final visit. FEV1 data taken within 6 hours of rescue medication was excluded from the analysis. Repeated measures of analysis of covariance model: change from baseline to final visit FEV1 = treatment + visit + treatment*visit interaction + baseline FEV1 + region + asthma related hospitalization in the last 12 months + asthma worsening in the last 12 months + African American patient.|Baseline to the end of treatment (varying durations, up to 21 months). At the following timepoints: 5 minutes post-dose, 30 minutes post-dose, 1 hour post-dose and 2 hours post-dose|Full analysis set: all randomized patients who received at least one dose of study medication. Participants with observations at both baseline and final visit were included in this analysis.||liters||Standard Error|Least Squares Mean
797528|NCT00941798|Secondary|Change From Baseline in Trough Forced Expiration Volume in 1 Second (FEV1) at Final Visit|Spirometry was conducted according to internationally accepted standards. Trough FEV1 was measured 15 minutes before dosing; measurements within 6 hours of rescue medication use were set to missing. Repeated measures of analysis of covariance model: change from baseline to trough FEV1 = treatment + visit + treatment*visit interaction + baseline FEV1 + region + asthma related hospitalization in the last 12 months + asthma worsening in the last 12 months + African American patient.|Baseline to the end of treatment (varying durations, up to 21 months)|Full analysis set: all randomized patients who received at least one dose of study medication. Participants with observations at both baseline and final visit were included in this analysis.||liters||Standard Error|Least Squares Mean
797529|NCT00941798|Secondary|Number of Patients With at Least One Asthma Worsening Post-baseline|The criterion for asthma worsening were: decrease in peak expiratory flow (PEF) >= 20% from mean baseline on >= 3 consecutive days, nighttime symptom score >= 2 on >= 2 consecutive nights, decrease in forced expiration volume in 1 second (FEV1) >=20% from baseline at evening visits, daytime symptom score of 3 or 4 on >= 2 consecutive days, requiring an urgent unscheduled visit for medical care, 24 hour rescue medication use >= 8 puffs on >= 2 consecutive days, and any other clinically important symptoms (pre-specified MedDRA preferred terms).|Up to 21 months|Full analysis set: all randomized patients who received at least one dose of study medication.||participants|||Number
797530|NCT00941798|Secondary|Patients With Asthma Exacerbations That Required Treatment With Systemic Corticosteroids|Number of patients requiring treatment with systemic corticosteroids (oral or parenteral) over the course of the study (up to 21 months).|Up to 21 months|Full analysis set: all randomized patients who received at least one dose of study medication.||participants|||Number
797531|NCT00941798|Secondary|Cumulative Incidence of the First Serious Asthma Exacerbation Resulting in Hospitalization, Intubation or Death.|The number of patients with at least one serious asthma exacerbation over the course of the study. A serious asthma exacerbation was one that resulted in hospitalization, intubation or death.|up to 21 months|Full analysis set: all randomized patients who received at least one dose of study medication.||participants|||Number
797532|NCT00941798|Primary|Time to First Serious Asthma Exacerbation|Defined as the number of days from start of treatment up to the first date when an asthma exacerbation becomes serious. A serious asthma exacerbation was one that resulted in hospitalization, intubation or death.|Up to 21 months|Full analysis set: all randomized patients who received at least one dose of study medication.||months||Full Range|Median
797533|NCT00941863|Other Pre-specified|Other Adverse Events|Frequency Threshold for reporting Other Adverse Events: 5%. The responses reported in these participants were from start of treatment until 18 Sep 2008.|From start of treatment until 18 Sep 2008, up to 6 years|25 of 119 participants from the Expansion Phase, were still on the treatment as of 31 May 2005. Of these, 6 subjects were continuing to receive sorafenib in combination with carboplatin and/or paclitaxel and 19 subjects were receiving single-agent sorafenib.||Participants|||Number
797534|NCT00941863|Other Pre-specified|Serious Adverse Events|The responses reported in these participants were from start of treatment until 18 Sep 2008.|From start of treatment until 18 Sep 2008, up to 6 years|25 of 119 participants from the Expansion Phase, were still on the treatment as of 31 May 2005. Of these, 6 subjects were continuing to receive sorafenib in combination with carboplatin and/or paclitaxel and 19 subjects were receiving single-agent sorafenib.||Participants|||Number
797535|NCT00941863|Secondary|Time of Maximum Concentration (TMAX) Start From Day 2 of Cycle 1|Tmax refers to the time after dosing when a drug attains its maximum concentration in the blood. It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content. The time corresponding to the highest measurable concentration (Cmax) is referred to as Tmax.|At day 2 in study|subjects with valid PK profiles||hours||Full Range|Median
797536|NCT00941863|Secondary|Maximum Concentration (CMAX) Start From Day 2 of Cycle 1|Cmax refers to the highest plasma concentration of drug reached after dosing. It is obtained by collecting a series of blood samples after dosing, and analyzing them for drug content by a sensitive and specific analytical method. The highest measured concentration is referred to as the Cmax.|At day 2 in study|subjects with valid PK profiles||mg/L||Standard Deviation|Geometric Mean
797537|NCT00941863|Secondary|Area Under the Curve From Time 0 to 12 Hours Post-dose (AUC 0-12) Start From Day 2 of Cycle 1|The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. A plot of concentration vs time after dosing is created, and the area under this curve is calculated by standard methods (eg, trapezoidal rule) to provide a measure of how much drug was in the bloodstream following dosing.|At day 2 in study|subjects with valid pharmacokinetics (PK) profiles||mg*h/L||Standard Deviation|Geometric Mean
797538|NCT00941863|Secondary|Tumor Response|Tumor Response (= Best Overall Response) of a subject was defined as the best tumor response (confirmed Complete Response (CR), confirmed Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)) observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR was defined as disappearance of tumor lesions, PR was defined as a decrease of at least 30% in the sum of tumor lesion sizes, SD was defined as steady state of disease, PD was defined as an increase of at least 20% in the sum of tumor lesions sizes.|From start of treatment until progression or death occurs assessed every 6 weeks.|The Intent-To-Treat (ITT) population included subjects who received at least one dose of sorafenib or chemotherapy and had at least one post baseline assessment. Efficacy analyses were performed on the ITT population||Participants|||Number
797555|NCT00942149|Secondary|Adverse Events Will be Monitored.||7 days following last dose of study drug||||||
797539|NCT00941863|Primary|Participants With Hematological and Biochemical Toxicities|Participants are considered at risk for toxicity if participants had a lab measurement for the toxicity >= National Cancer Institute Common Toxicity Criteria (NCI CTC) Grade 3 as defined by the NCI CTC version 2; SGOT: Serum Glutamic-Oxaloacetic Transaminase, SGPT: Serum Glutamic-Pyruvic Transaminase, AST: Aspartate Aminotransferase, ALT: Alanine Aminotransferase.|Start of treatment until death or within 14 days last study drug intake|The Intent-To-Treat (ITT) population included subjects who received at least one dose of sorafenib or chemotherapy and had at least one post baseline assessment. Efficacy analyses were performed on the ITT population.||Participants|||Number
797540|NCT00941863|Primary|Maximum Tolerated Dose (MTD) of Sorafenib in Combination With Paclitaxel and Carboplatin|MTD was determined by testing increasing doses up to 400 mg twice daily (bid) on dose escalation cohorts 1 to 3 with 3 patients each. MTD reflects highest dose of drug that did not cause an unacceptable side effect (= Dose Limiting Toxicity (DLT) in more than 30% of patients; e.g., hematologic toxicities like Common Toxicity Criteria (CTC) Grade 4 Neutropenia in specific conditions, platelets < 25,000 cells/mL; specific non-hematologic/biochemical toxicities CTC Grade 3 or 4; additionally, any toxicity considered by the investigator severe enough was designated a DLT); CTC Version 2 were used.|21 days|All subjects who received at least 1 dose of any study drug treatment were included in the Intent-To-Treat/safety populations. Efficacy parameters of time to death, time to progression, and response rate (confirmed partial response [PR] plus complete response [CR]) were determined for this population.||mg|||Number
797541|NCT00941889|Primary|The Primary Endpoint of This Study is Persistence and Recurrence of Anal Warts as Compared Between the Experimental and Control Groups.|Persistence of anal warts will be measured by the presence of any lesions at one month follow-up after surgery. Recurrence of anal warts will be measured by the development of new lesions after one month of follow-up.|Follow up evaluation after treatment at 1, 3, 6, 9. 12, 15, 18 months after initial treatment|Five patients from the placebo group and seven patients from the gardasil group completed all three injections per the protocol. The remaining patients did not complete study-required follow-up and therefore could not be analyzed. One patient from the Gardasil Group and one patient from the placebo group met the outcome measure of recurrence.||participants|||Number
797542|NCT00941928|Secondary|Overall Survival (OS)|Number of surviving participants without disease progression or death for any reason at one year post treatment.|Minimum of 1 year, or until disease progression or death||||||
797543|NCT00941928|Primary|Time to Progression (TTP)|TTP calculated as average time, in months, from baseline to participants disease progression or death, monitored for a minimum of 1 year|1 Year|Both participants had recurrent disease before single month assessment therefore no data was analyzed. Study was terminated early due to slow accrual.|||||
797544|NCT00941993|Primary|Evaluate Any Adverse Effects Associated With the Iontophoresis System (Adverse Device Effects).||Day 0|||participants|||Number
797545|NCT00941993|Other Pre-specified|Patient Tolerability of In-office Ear Treatment Using the Wong Baker FACES Pain Scale.|"The Wong-Baker FACES pain scoring system is a subject-reported instrument using a scale of 0 to 5, where 0 means 'no hurt', 1 = 'hurts a little bit', 2 = 'hurts little more', 3 = 'hurts even more', 4 = 'hurts whole lot' and 5 = 'hurts worst'.
Pain scores were recorded for all subjects for which an ear procedure was attempted.Pain scores are presented by subject, as an average of pain scores for both ears."|Day 0|Analysis population includes subjects who completed anesthesia and for which an ear procedure was attempted||units on a scale||Standard Deviation|Mean
797546|NCT00941993|Secondary|Subject/Parent Reported Satisfaction With the In-office Procedure|"Adult subjects or parents of pediatric subjects were asked to rate their agreement or disagreement with the statement: ‘Overall, I am satisfied with the whole procedure’. Response options included: ‘Strongly Disagree’, ‘Disagree’, ‘Neutral’, ‘Agree’ or ‘Strongly Agree’. The number of respondents who reported that they ‘agree’ or ‘strongly agree’ that they were satisfied with the whole procedure are reported.
The analysis population does not include the full study cohort as this survey question was implemented during, not prior to, the enrollment period."|Day 0|||% adult subjects or parents||95% Confidence Interval|Number
797547|NCT00941993|Secondary|Patient Tolerability of Iontophoresis Procedure Will be Measured Using a Wong Baker Faces Pain Scale|"Includes all subjects for whom Iontophoresis current delivery was initiated.
The Wong-Baker FACES pain scoring system is a scale of 0 to 5, where 0 means 'no hurt', 1 = 'hurts a little bit', 2 = 'hurts little more', 3 = 'hurts even more', 4 = 'hurts whole lot' and 5 = 'hurts worst'.
The Wong-Baker scores are reported by subject."|Day 0|Analysis population includes subjects completing iontophoresis for which Wong Baker scores are available.||units on a scale||Standard Deviation|Mean
797548|NCT00941993|Primary|Proportion of Subjects Who Achieved Anesthesia Effectiveness Per Investigator Assessment|Investigator performed a gentle tap of the tympanic membrane to assess whether adequate anesthesia was achieved following local anesthesia by iontophoresis. All subjects for which an ear procedure was attempted were considered to have achieved anesthesia effectiveness.|Day 0|||percentage of subjects||95% Confidence Interval|Number
797549|NCT00942084|Primary|Minimum Steady State Concentration (Cminss)||up to 3 days of study drug administration and 10 days of safety monitoring|32 infants enrolled. 2 infants died. 2 infants did not contribute PK samples to the analysis. 28 contributed PK samples to the final analysis.||mg/L||Full Range|Median
797550|NCT00942084|Primary|Steady State Concentration at 50% of the Dosing Interval (C50ss)||up to 3 days of study drug administration and 10 days of safety monitoring|32 infants enrolled. 2 infants died. 2 infants did not contribute PK samples to the analysis. 28 contributed PK samples to the final analysis.||mg/L||Full Range|Median
797551|NCT00942084|Primary|Maximum Steady State Concentration (Cmaxss)||up to 3 dasy of study drug administration and 10 days of safety monitoring|32 infants enrolled. 2 infants died. 2 infants did not contribute PK samples to the analysis. 28 contributed PK samples to the final analysis.||mg/L||Full Range|Median
797552|NCT00942084|Primary|Half-life (T1/2)||up to 3 days of study drug administration and 10 days of safety monitoring|32 infants enrolled. 2 infants died. 2 infants did not contribute PK samples to the analysis. 28 contributed PK samples to the final analysis.||h||Full Range|Median
797553|NCT00942084|Primary|Volume of Distribution (V)||up to 3 days of study drug administration and 10 days of safety monitoring|32 infants enrolled. 2 infants died. 2 infants did not contribute PK samples to the analysis. 28 contributed PK samples to the final analysis.||L/kg||Full Range|Median
797556|NCT00942149|Primary|PK of Daptomycin|Area under the curve|24 hours|all 20 subjects were analyzed||mg*h/L||Full Range|Median
797558|NCT00942175|Primary|Pharmacodynamic Parameter Maximum Platelet Aggregation (MPA) From Aggregometry (Turbidimetric) With 5 µM Adenosine Diphosphate.|Maximum platelet aggregation (MPA) from aggregometry (turbidimetric) with 5 µM adenosine diphosphate.|24-hour post Day 9 dose in each period.|All participants who had valid parameter estimates for both formulations within PPI groups were included in the PD statistical analyses for those parameters.||percentage of MPA||Standard Deviation|Mean
797559|NCT00942175|Primary|Pharmacodynamic Parameter Platelet Reactivity Index (PRI) From Vasodilator-stimulated Phosphoprotein (VASP) Phosphorylation State (Flow Cytometry).|PRI is the platelet reactivity index from VASP phosphorylation state (flow cytometry).|24-hour post Day 9 dose in each period.|All participants who had valid parameter estimates for both regimens within a PPI group were included in the pharmacodynamics (PD) statistical analyses for this parameter.||percent inhibition||Standard Deviation|Mean
797560|NCT00942175|Primary|Pharmacokinetic Parameter Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]) of Clopidogrel’s Active Metabolite.|Area under the plasma concentration versus time curve (AUC(0-tlqc)) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]).|Day 9 of each period|All participants who had valid parameter estimates for both formulations within PPI groups were included in the PK statistical analyses for those parameters.||ng*hr/ML||Standard Deviation|Mean
797561|NCT00942175|Primary|Pharmacokinetic Parameter Peak Plasma Concentration (Cmax) of Clopidogrel’s Active Metabolite.|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Day 9 of each period|All participants who had valid parameter estimates for both regimens within a PPI group were included in the pharmacokinetics (PK) statistical analyses for this parameter.||ng/mL||Standard Deviation|Mean
797562|NCT00942266|Secondary|Fluorouracil Steady-state Pharmacokinetics|Blood samples will be collected for determination of plasma 5-FU steady state concentration at 6 hours after start of 5-FU continuous infusion. The mean per treatment arm are presented.|Day 1|All treated and eligible patients||ng/ml||95% Confidence Interval|Mean
797563|NCT00942266|Secondary|Vorinostat Pharmacokinetics|Blood samples (5 ml of blood each) will be collected in red-top vacutainers (no anticoagulant) at 0 (pre- vorinostat), 0.5, 1, 2, 3, 4, 6, and 8 hours after the vorinostat dose on the first day of 5-FU infusion on cycle 1 (day 2 of cycle 1). Mean area under the curve is presented with 95% CI.|day 2 (cycle 1)|Vorinostat PKs were be performed on day 2 of vorinostat in the first 10 patients of each arm treated at RPCI||hr∙μM||95% Confidence Interval|Mean
797564|NCT00942266|Secondary|Overall Survival||Every 12 weeks|All treated and eligible patients; per protocol||months||95% Confidence Interval|Median
797565|NCT00942266|Secondary|Toxicity|"Number of participants with an adverse event.
Please refer to the adverse event reporting for more detail."|Daily|All treated and eligible patients; per protocol||participants|||Number
797566|NCT00942266|Secondary|Response Rate|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI:
Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|Every 8 weeks; up to 100 weeks.|All treated and eligible patients; per protocol||percentage of participants||95% Confidence Interval|Number
797567|NCT00942266|Secondary|Median Progression-free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Every 8 weeks, up to 100 weeks.|All treated and eligible patients; per protocol||months||95% Confidence Interval|Median
797568|NCT00942266|Primary|Disease Control Rate (Stable Disease or Objective Response)|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI:
Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|At 2 months|All treated and eligible patients; per protocol||percentage of participants||95% Confidence Interval|Number
797569|NCT00942409|Primary|Overall Response Rate||2 Years|The study was not completed due to unavailability of the study drug, and therefore data were not collected for this Outcome Measure|||||
797570|NCT00942422|Primary|Sustained M-protein Reduction of ≥ 25% From Baseline|"This is a monthly blood test, done at the beginning of each cycle of therapy. The M-protein is a surrogate marker routinely used to estimate the degree of plasma cell cyto-reduction brought about by therapy. In active multiple myeloma, a 25% reduction in the M-protein level would correspond to a minor response, an improvement recognized as having some clinical benefit."|Day one of each 28-day cycle for a total of up to 6 cycles|||percentage of patients|||Number
797571|NCT00942448|Primary|Pain Intensity Difference (PID) on a 0-100 VAS|Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).|at 1.5 hours after treatment administration|The reported number of analized participants were included in the ITT which was defined as all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint);||mm||95% Confidence Interval|Least Squares Mean
797572|NCT00942448|Secondary|PID|Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).|at 8 hours post-dose.|The reported number of analized participants were included in the ITT which was defined as all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint);||mm||Standard Deviation|Mean
797573|NCT00942448|Secondary|PID|Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).|at 7 hours post-dose.|The reported number of analized participants were included in the ITT which was defined as all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint);||mm||Standard Deviation|Mean
799486|NCT00947791|Secondary|Quick Inventory of Depressive Symptomatology, Self Report (QIDS-SR)||24 hrs post-infusion compared to baseline|Based on confidentiality concerns, 0 participants analyzed.|||||
797574|NCT00942448|Secondary|PID|Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).|at 6 hours post-dose.|The reported number of analized participants were included in the ITT which was defined as all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint);||mm||Standard Deviation|Mean
797575|NCT00942448|Secondary|PID|Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).|at 5 hours post-dose.|The reported number of analized participants were included in the ITT which was defined as all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint);||mm||Standard Deviation|Mean
797576|NCT00942448|Secondary|PID|Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).|at 4 hours post-dose.|The reported number of analized participants were included in the ITT which was defined as all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint);||mm||Standard Deviation|Mean
797577|NCT00942448|Secondary|PID|Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).|at 3 hours post-dose.|The reported number of analized participants were included in the ITT which was defined as all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint);||mm||Standard Deviation|Mean
797578|NCT00942448|Secondary|PID|Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).|at 2 hours post-dose.|The reported number of analized participants were included in the ITT which was defined as all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint);||mm||Standard Deviation|Mean
797579|NCT00942448|Secondary|PID|Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).|at 90 minutes post-dose.|The reported number of analized participants were included in the ITT which was defined as all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint);||mm||Standard Deviation|Mean
797580|NCT00942448|Secondary|PID|Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).|at 60 minutes post-dose.|The reported number of analized participants were included in the ITT which was defined as all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint);||mm||Standard Deviation|Mean
797581|NCT00942448|Secondary|PID|Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).|at 45 minutes post-dose.|The reported number of analized participants were included in the ITT which was defined as all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint);||mm||Standard Deviation|Mean
797582|NCT00942448|Secondary|PID|Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).|at 30 minutes post-dose.|The reported number of analized participants were included in the ITT which was defined as all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint);||mm||Standard Deviation|Mean
797583|NCT00942448|Secondary|PID|Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).|at 15 minutes post-dose.|The reported number of analized participants were included in the ITT which was defined as all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint);||mm||Standard Deviation|Mean
797584|NCT00942448|Primary|Pain Intensity Difference (PID) on a 0-100 VAS|Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).|at 1.5 hours after treatment administration|The reported number of analized participants were included in the ITT which was defined as all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint);||mm||95% Confidence Interval|Least Squares Mean
797585|NCT00942604|Secondary|Proportion of Patients With Partial Clearance of Actinic Keratoses (AK) Lesions|Proportion of patients with Partial Clearance defined as ≥ 75 % reduction in the number of Actinic Keratoses (AK) lesions identified at baseline in the treatment area|57 days|Intention to treat population||participants|||Number
797586|NCT00942604|Primary|Proportion of Patients With Complete Clearance of Actinic Keratoses (AK) Lesions|Proportion of Patients with Complete Clearance of the treatment field defined as no clinically visible Actinic Keratoses (AK) lesions in the selected treatment area|57 days|Intention to treat population||participants|||Number
797615|NCT00942994|Other Pre-specified|Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 2 and Week 4|Secondary objective at additional timepoint.|Baseline, Week 2 and Week 4|Analysis was based on the Full Analysis Set consisting of all patients to whom study medication had been assigned. Last-observation-carried-forward was used. Baseline was not carried forward. In the Aliskiren/Amlodipine/HCTZ group, 5 patients did not have a post baseline measure. Hence, change from baseline is reported for 197 patients.||mmHg||Standard Deviation|Mean
797587|NCT00942734|Primary|12-Week Progression-Free Survival (PFS)|Tumor assessments performed by Computed Tomography (CT) scan or Magnetic Resonance Imaging (MRI) after 4 weeks, 12 weeks, then every 8 weeks thereafter. Participants who received at least one dose of RAD001+erlotinib and who die before 12 weeks, counted as having progressive disease. Response Evaluation Criteria in Solid Tumors (RECIST) defined as Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): >30% decrease in sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. Progression-free survival defined as stable disease or better. Progressive Disease (PD): >20% increase in sum of LD of target lesions, taking as reference smallest sum LD recorded since treatment started or appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference smallest sum LD since treatment started.|12 weeks|Eight participants were not evaluable.||Percentage of Participants|||Number
797588|NCT00942786|Other Pre-specified|Association Between Preoperative NT-ProBNP and Occurence of Adverse Cardiac Events|Evaluation of the association between preoperative NT-ProBNP and occurence of adverse cardiac events|postoperatively (index surgery) until a median follow-up of 34 months|||pg/ml||Inter-Quartile Range|Median
797589|NCT00942786|Other Pre-specified|NT-ProBNP Preoperative|NT-ProBNP was measured 0-24 hours before induction of anesthesia|0-24 hours before induction of anesthesia|Consecutive patients undergoing emergent non-cardiac surgery||pg/ml||Inter-Quartile Range|Median
797590|NCT00942786|Primary|Occurence of Adverse Cardiac Events|"Occurence of major adverse cardiac events (composite of nonfatal myocardial infarction, acute heart failure or death).
Non-fatal Myocardial infarction was defined as a typical increase and decrease of troponin together with evidence of myocardial ischemia with at least one of the following: symptoms of ischemia, ECG changes indicative of ischemia or new Q waves, or imaging evidence of new regional wall motion abnormality.
Acute heart failure was defined as clinical signs and symptoms of heart failure with echocardiographic evidence of cardiac dysfunction and clinical response to treatment directed towards heart failure."|postoperatively (index surgery) until a median follow-up of 34 months|||participants|||Number
797591|NCT00942825|Primary|The Primary Efficacy Endpoint is Progression Free Survival, Analyzed in the Treated Population. PFS is Assessed From Randomization Until Either Tumor Progression, as Per RECIST Criteria, or Until Death Due to Any Reason.||15 June 2009 to 30 September 2012|Treated population||days||95% Confidence Interval|Median
797592|NCT00942851|Secondary|% Blepharospasm Disability Scale (BDS) Change at 3 Months|% BDS change at 3 months. The BDS is a quality of life scale ranging from 0 (no symptoms) to 26 (maximum impact of symptoms on quality of life). The questions are specific for impairment related to blepharospasm. We compared the percentage change over three months in the active and placebo arms.|baseline to 3 months|One placebo arm participant discontinued study due to unrelated personal problems||percentage change||Standard Deviation|Mean
797593|NCT00942851|Secondary|Change in the JBRS at 3 Months|The JBRS is a severity scale for blepharospasm, ranging from 0 (no symptoms) to 8 (the most severe symptoms, functionally blind). It includes measures of blink frequency and severity of abnormal eye closure. The scale was measured at baseline (before intervention) and followed over time.|baseline to 3 months|One placebo arm participant dropped out due to unrelated personal problems||points||Standard Deviation|Mean
797594|NCT00942851|Primary|Time Until Jankovic Blepharospasm Rating Scale (JBRS) Reverts Back to Baseline|The JBRS is a severity scale for blepharospasm, ranging from 0 (no symptoms) to 8 (the most severe symptoms, functionally blind). It includes measures of blink frequency and severity of abnormal eye closure. The scale was measured at baseline (before intervention) and followed over time. Return to baseline value represents loss of benefit from BoNT injection. The time to return to baseline JBRS is an indication of added benefit from the topical intervention.|3-7 months|||month||Standard Deviation|Mean
797595|NCT00942903|Secondary|Noise at Stoma Occlusion|the number of patients presenting any hissing, whistling, or plopping noises before, during, or after stoma occlusion while using the new XtraHME|3 weeks|||patients|||Number
797596|NCT00942903|Primary|Patient Preference for Provox HME or Provox XtraHME|the patient preference is based on a structured questionnaire on several aspects regarding the use of the new Provox XtraHME in comparison with the Provox HME.|3 weeks|||Patients|||Number
797597|NCT00942968|Other Pre-specified|Change From Baseline in Creatinine Clearance at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 in Severely Renal Impaired Participants|Creatinine clearance is an indicator of renal function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 milliliters per minute (mL/min) and for females, 90-125 mL/min. Creatinine clearance decreases with age.|Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|Severely renal-impaired population included all participants who had at least 1 dose of study drug and had severe renal impairment at the baseline or developed severe renal impairment (CrCl) < 30 milliliter per minute during the study. Here, n’ signifies those participants who were evaluable at specified time points.||mL/min||Standard Deviation|Mean
797598|NCT00942968|Other Pre-specified|Other Pre-specified: Number of Participants With Clinically Significant Electrocardiogram Findings|Clinically significant ECG findings included: corrected QT (QTc) > 450 ms, QTc >500 ms, change in QTc between 30 and 60 ms, change in QTc greater than or equal to 60 ms.|Baseline up to Week 52|Safety population included all participants who received at least 1 treatment with dalteparin sodium.||participants|||Number
797599|NCT00942968|Other Pre-specified|Number of Participants With Abnormal Physical Examinations Findings|Physical examinations included head, ears, nose, throat (ENT), neck, heart, chest, lungs, abdomen, extremities, neurological systems, skin, general appearance and others (thigh, abdomen unobtrusive scar, breast, cardio-vascular, constitutional, face, genitalia, genitourinary, gastrointestinal, hematologic, left ankle unobtrusive scar, lymph nodes, lymphatic, malaise/fatigue, mouth, musculoskeletal, musculoskeletal, peripherally inserted central catheters line site left arm, psychiatric, skeletal, urinary, weight, activity level, bladder irritation, dyspnea and eastern cooperative oncology group performance status [used to assess how the disease affects the daily living abilities of the participant. It ranges on the scale from 0-5 (0= normal activity; 1= symptoms but ambulatory; 2= in bed for less than (<) 50 percent (%) of the time; 3= in bed for greater than (>) 50% of the time; 4= 100% bedridden; 5= dead]). Abnormality in physical examinations was based on investigator’s discretion.|Baseline (Day 1), Week 1, 4, 8, 12, 24, 36, 48, 52|Safety population included all participants who received at least 1 treatment with dalteparin sodium. Here ‘n’ signifies those participants who were evaluable at specified categories.||participants|||Number
797600|NCT00942968|Other Pre-specified|Number of Participants With Clinically Significant Laboratory Abnormalities|Criteria for abnormality: Hemoglobin greater than or equal to(>=)130*lower limit of normal(LLN); less than or equal to(<=)170*upper limit of normal(ULN), hematocrit >=0.39*LLN;<=0.51*ULN, red blood cell >=4.5*LLN;<=5.9*ULN, platelet>=150*LLN;<= 450*ULN, white blood cells >=4*LLN;<=11*ULN; lymphocytes>=0.09;<=0.44, neutrophils=>0.16*LLN;<=0.7*ULN, eosinophils<=0.04*ULN, basophils<=0.02*ULN, monocytes>0.08*ULN; bilirubin >=5.1*LLN;<=22.2*ULN, aspartate aminotransferase >=13*LLN;<=36*ULN, alanine aminotransferase>=11*LLN;<=54*ULN, alkaline phosphatase>=31*LLN ;<=104 *ULN, total protein>=60*LLN; <=76*ULN, albumin=>35*LLN;<=50*ULN, glucose>=3.77 ;<=6.05;blood urea nitrogen>=1.785*LLN;<=7.5*ULN, creatinine>=70.7*LLN;<=114.9*ULN, creatinine kinase>=30*LLN ;<=280*ULN, lactate dehydrogenase>=85*LLN;<=180*ULN, sodium>=137*LLN ;<=144*ULN, potassium >=3.5*LLN;<=5*ULN, chloride>=102*LLN;<=111*ULN, calcium>=2.22*LLN ;<=2.57*ULN, phosphorus=>0.81 ;<=1.45); nitrogen cholesterol>=1.78*LLN ;<=7.49*ULN.|Baseline (Day 1) up to Week 52|Safety population included all participants who received at least 1 treatment with dalteparin sodium.||participants|||Number
797601|NCT00942968|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Week 52 that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs.|Baseline (Day 1) up to Week 52|Safety population included all participants who received at least 1 treatment with dalteparin sodium.||participants|||Number
797602|NCT00942968|Secondary|Time to First Occurrence of New or Recurrent VTE or CVT Adjudicated by Central Adjudication Committee|Time to first occurrence of new or recurrent VTE or CVT was defined as the time interval (in days) between the date of first study treatment and the date of documentation of first VTE or CVT. VTEs included both deep vein thrombosis (DVT) and pulmonary embolism (PE) .DVT is a blood clot in the deep veins of the leg. If a DVT clot that breaks off (embolizes) from a vein wall and flows towards the lungs and blocks some or all of the blood supply, it becomes pulmonary embolism (PE). When a blood clot (thrombus) breaks, loose and travels in the blood, this is called a venous thromboembolism. DVT was diagnosed using either computed tomography scan, contrast venography or contrast venography. PE was diagnosed by either radionuclide ventilation-perfusion studies, contrast CT scan or an angiogram. CVT is blood clot of the venous channels in the brain. CVT was diagnosed by contrast venography or ultrasonography.|Month 1 up to Month 12|Efficacy analysis population included all participants who received at least 1 study treatment with dalteparin sodium.||days||Standard Error|Mean
797603|NCT00942968|Secondary|Time to First Occurrence of New or Recurrent Venous Thromboembolism (VTE) Adjudicated by Central Adjudication Committee|Time to first occurrence of new or recurrent VTE was defined as the time interval (in days) between the date of first study treatment and the date of documentation of first VTE. VTEs included both DVT and PE. DVT is a blood clot in the deep veins of the leg. If a DVT clot breaks off (embolizes) from a vein wall and flows towards the lungs and blocks some or all of the blood supply, it becomes PE. When a blood clot (thrombus) breaks, loose and travels in the blood, this is called a venous thromboembolism. DVT was diagnosed using either computed tomography scan or contrast venography. PE was diagnosed by either radionuclide ventilation-perfusion studies, contrast CT scan or an angiogram.|Month 1 up to Month 12|Efficacy analysis population included all participants who received at least 1 study treatment with dalteparin sodium.||days||Standard Error|Mean
797604|NCT00942968|Secondary|Number of Participants With Investigator Identified New or Recurrent Venous Thromboembolism (VTE) or Central Venous Thrombosis (CVT)|VTEs included both DVT and PE. DVT is a blood clot in the deep veins of the leg. If a DVT clot breaks off (embolizes) from a vein wall and flows towards the lungs and blocks some or all of the blood supply, it becomes PE. When a blood clot (thrombus) breaks, loose and travels in the blood, this is called a venous thromboembolism. DVT was diagnosed using either computed tomography scan or contrast venography. PE was diagnosed by either radionuclide ventilation-perfusion studies, contrast CT scan or an angiogram. CVT is blood clot of the venous channels in the brain. CVT was diagnosed by contrast venography or ultrasonography. In this outcome measure, number of participants with new or recurrent VTE or CVT (identified by investigator) were reported.|Month 1 up to Month 6; Month 7 up to Month 12; Month 1 up to Month 12; Month 2 up to Month 6; Month 2 up to Month 12|Efficacy analysis population included all participants who received at least 1 study treatment with dalteparin sodium. Here, ‘n’ signifies those participants who were evaluable at specified time intervals.||participants|||Number
797605|NCT00942968|Secondary|Number of Participants With New or Recurrent Venous Thromboembolism (VTE) or Central Venous Thrombosis (CVT) Adjudicated by Central Adjudication Committee|VTEs included both DVT and PE. DVT is a blood clot in the deep veins of the leg. If a DVT clot breaks off (embolizes) from a vein wall and flows towards the lungs and blocks some or all of the blood supply, it becomes PE. When a blood clot (thrombus) breaks, loose and travels in the blood, this is called a venous thromboembolism. DVT was diagnosed using either computed tomography scan or contrast venography. PE was diagnosed by either radionuclide ventilation-perfusion studies, contrast CT scan or an angiogram. CVT is blood clot of the venous channels in the brain. CVT was diagnosed by contrast venography or ultrasonography. In this outcome measure, number of participants with new or recurrent VTE or CVT (adjudicated by Central Adjudication Committee) were reported.|Month 1 up to Month 6; Month 7 up to Month 12; Month 1 up to Month 12; Month 2 up to Month 6; Month 2 up to Month 12|Efficacy analysis population included all participants who received at least 1 study treatment with dalteparin sodium. Here, ‘n’ signifies those participants who were evaluable at specified time intervals.||participants|||Number
797614|NCT00942968|Primary|Number of Participants With Major Bleeding Events Adjudicated by Central Adjudication Committee|A bleeding event was considered as major if it was clinically overt and satisfies 1 or more of the following criteria: 1) bleeding accompanied by a decrease in hemoglobin of greater than or equal to (>=) 2 gram per deciliter (g/dL), 2) bleeding occurred at a critical site (intraocular, spinal/epidural, intracranial, retroperitoneal, or pericardial bleeding), 3) bleeding leads to a transfusion of two or more units of packed red blood cells, 4) bleeding leads to death. In this outcome measure, number of participants with major bleeding events (adjudicated by Central Adjudication Committee) were reported.|Month 2 up to Month 6|Safety population included all participants who received at least 1 treatment with dalteparin sodium.||participants|||Number
797606|NCT00942968|Secondary|Number of Participants With Investigator Identified New or Recurrent Venous Thromboembolism (VTEs)|VTEs included both DVT and PE. DVT is a blood clot in the deep veins of the leg. If a DVT clot breaks off (embolizes) from a vein wall and flows towards the lungs and blocks some or all of the blood supply, it becomes PE. When a blood clot (thrombus) breaks, loose and travels in the blood, this is called a venous thromboembolism. DVT was diagnosed using either computed tomography scan or contrast venography. PE was diagnosed by either radionuclide ventilation-perfusion studies, contrast CT scan or an angiogram. In this outcome measure, number of participants with new or recurrent VTE (identified by investigator) were reported.|Month 1 up to Month 6; Month 7 up to Month 12; Month 1 up to Month 12; Month 2 up to Month 6; Month 2 up to Month 12|Efficacy analysis population included all participants who received at least 1 study treatment with dalteparin sodium. Here, 'n' signifies those participants who were evaluable at specified time intervals.||participants|||Number
797607|NCT00942968|Secondary|Time to First Occurrence of Any Bleeding Event (Major or Minor) Adjudicated by Central Adjudication Committee|Time to first occurrence of any bleeding event was defined as the time interval (in days) between the date of first study treatment and the date of documentation of first bleeding event (major or minor). A bleeding event was considered as major if it was clinically overt and satisfies 1 or more of the following criteria: 1) bleeding accompanied by a decrease in hemoglobin of >=2 g/dL, 2) bleeding occurred at a critical site (intraocular, spinal/epidural, intracranial, retroperitoneal, or pericardial bleeding), 3) bleeding leads to a transfusion of two or more units of packed red blood cells, 4) bleeding leads to death. A bleeding event was considered as minor if it was clinically overt but not meeting the criteria for major bleeding.|Month 1 up to Month 12|Safety population included all participants who received at least 1 treatment with dalteparin sodium.||days||Standard Error|Mean
797608|NCT00942968|Secondary|Time to First Occurrence of Major Bleeding Event Adjudicated by Central Adjudication Committee|Time to first occurrence of major bleeding event was defined as the time interval (in days) between the date of first study treatment and the date of documentation of first major bleeding event. A bleeding event was considered as major if it was clinically overt and satisfies 1 or more of the following criteria: 1) bleeding accompanied by a decrease in hemoglobin of >=2 g/dL, 2) bleeding occurred at a critical site (intraocular, spinal/epidural, intracranial, retroperitoneal, or pericardial bleeding), 3) bleeding leads to a transfusion of two or more units of packed red blood cells, 4) bleeding leads to death.|Month 1 up to Month 12|Safety population included all participants who received at least 1 treatment with dalteparin sodium.||days||Standard Error|Mean
797609|NCT00942968|Secondary|Number of Participants With Fatal Bleeding Events|Fatal bleeding events refers to those bleeding events which leads to death of participant. In this outcome measure, number of participants with fatal bleeding events were reported.|Month 1 up to Month 6; Month 7 up to Month 12; Month 1 up to Month 12; Month 2 up to Month 6; Month 2 up to Month 12|Safety population included all participants who received at least 1 treatment with dalteparin sodium.||participants|||Number
797610|NCT00942968|Secondary|Number of Participants With Any Bleeding Event (Major or Minor) Adjudicated by Central Adjudication Committee|A bleeding event was considered as major if it was clinically overt and satisfies 1 or more of the following criteria: 1) bleeding accompanied by a decrease in hemoglobin of >=2 g/dL, 2) bleeding occurred at a critical site (intraocular, spinal/epidural, intracranial, retroperitoneal, or pericardial bleeding), 3) bleeding leads to a transfusion of two or more units of packed red blood cells, 4) bleeding leads to death. A bleeding event was considered as minor if it was clinically overt but not meeting the criteria for major bleeding. In this outcome measure, number of participants with any (major or minor) bleeding events (adjudicated by Central Adjudication Committee) were reported.|Month 1 up to Month 6, Month 7 up to Month 12, Month 1 up to Month 12, Month 2 up to Month 6, and Month 2 up to Month 12|Safety population included all participants who received at least 1 treatment with dalteparin sodium.||participants|||Number
797611|NCT00942968|Secondary|Number of Participants With Investigator Identified Major Bleeding Events|A bleeding event was considered as major if it was clinically overt and satisfies 1 or more of the following criteria: 1) bleeding accompanied by a decrease in hemoglobin of >=2 g/dL, 2) bleeding occurred at a critical site (intraocular, spinal/epidural, intracranial, retroperitoneal, or pericardial bleeding), 3) bleeding leads to a transfusion of two or more units of packed red blood cells, 4) bleeding leads to death. In this outcome measure, number of participants with major bleeding events (identified by investigator) were reported.|Month 1 up to Month 6; Month 7 up to Month 12; Month 1 up to Month 12; Month 2 up to Month 6; Month 2 up to Month 12|Safety population included all participants who received at least 1 treatment with dalteparin sodium.||participants|||Number
797612|NCT00942968|Primary|Number of Participants With New or Recurrent Venous Thromboembolism (VTE) Adjudicated by Central Adjudication Committee|VTEs included both deep vein thrombosis (DVT) and pulmonary embolism (PE). DVT is a blood clot in the deep veins of the leg. If a DVT clot breaks off (embolizes) from a vein wall and flows towards the lungs and blocks some or all of the blood supply, it becomes pulmonary embolism (PE). When a blood clot (thrombus) breaks, loose and travels in the blood, this is called a venous thromboembolism. DVT was diagnosed using either computed tomography scan or contrast venography. PE was diagnosed by either radionuclide ventilation-perfusion studies, contrast CT scan or an angiogram. In this outcome measure, number of participants with new or recurrent VTE (adjudicated by Central Adjudication Committee) were reported.|Month 7 up to Month 12|Efficacy analysis population included all participants who received at least 1 study treatment with dalteparin sodium. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||participants|||Number
797613|NCT00942968|Primary|Number of Participants With Major Bleeding Events Adjudicated by Central Adjudication Committee|A bleeding event was considered as major if it was clinically overt and satisfies 1 or more of the following criteria: 1) bleeding accompanied by a decrease in hemoglobin of >=2 g/dL, 2) bleeding occurred at a critical site (intraocular, spinal/epidural, intracranial, retroperitoneal, or pericardial bleeding), 3) bleeding leads to a transfusion of two or more units of packed red blood cells, 4) bleeding leads to death. In this outcome measure, number of participants with major bleeding events (adjudicated by Central Adjudication Committee) were reported.|Month 7 up to Month 12|Safety population included all participants who received at least one 1 treatment with dalteparin sodium.||participants|||Number
797632|NCT00943098|Secondary|PIDs||at 3 hours post-dose.|Analysed patients were included in the ITT population: all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint).||mm||Standard Deviation|Mean
797616|NCT00942994|Other Pre-specified|Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 2 and Week 4|Primary objective at additional timepoint.|Baseline, Week 2 and Week 4|Analysis was based on the Full Analysis Set consisting of all patients to whom study medication had been assigned. Last-observation-carried-forward was used. Baseline was not carried forward. In the Aliskiren/Amlodipine/HCTZ group, 5 patients did not have a post baseline measure. Hence, change from baseline is reported for 197 patients.||mmHg||Standard Deviation|Mean
797617|NCT00942994|Secondary|Percentage of Responders (Defined as Patients With MSSBP < 140 mmHg or a Reduction From Baseline in MSSBP of ≥20 mmHg) During 8 Weeks.|To compare the cumulative percentage of responders (defined as patients with MSSBP <140 mmHg or a decrease from baseline ≥20 mmHg) during 8 weeks of treatment with an aliskiren, amlodipine, and HCTZ treatment regimen versus an aliskiren and amlodipine treatment regimen in minority patients with Stage 2 hypertension. Cumulative refers to achieving a response before or at the corresponding visit.|8 weeks|Analysis was based on the Full Analysis Set (FAS) consisting of all patients to whom study medication had been assigned.||Percentage of Responders|||Number
797618|NCT00942994|Secondary|Percentage of Patients Achieving Blood Pressure Control (Defined as MSSBP < 140 mmHg and MSDBP < 90 mmHg) During 8 Weeks|To evaluate the cumulative percentage of patients achieving Blood Pressure control (defined as patients achieving an MSSBP <140 mmHg and MSDBP <90 mmHg) during 8 weeks of treatment with an aliskiren, amlodipine, and HCTZ treatment regimen versus an aliskiren and amlodipine treatment regimen in minority patients with Stage 2 hypertension. Cumulative refers to achieving BP control before or at the corresponding visit.|8 weeks|Analysis was based on the Full Analysis Set (FAS) consisting of all patients to whom study medication had been assigned.||Percentage of Participants|||Number
797619|NCT00942994|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8|To evaluate change from baseline in MSDBP after 8 weeks of treatment with an aliskiren, amlodipine, and HCTZ treatment regimen versus an aliskiren and amlodipine treatment regimen in minority patients with Stage 2 hypertension.|Baseline and week 8|Analysis was based on the Full Analysis Set consisting of all patients to whom study medication had been assigned. Last-observation-carried-forward was used. Baseline was not carried forward. In the Aliskiren/Amlodipine/HCTZ group, 5 patients did not have a post baseline measure. Hence, change from baseline to week 8 is reported for 197 patients.||mmHg||Standard Deviation|Mean
797620|NCT00942994|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8|To evaluate change from baseline in MSSBP after 8 weeks of treatment with an aliskiren, amlodipine, and HCTZ treatment regimen versus an aliskiren and amlodipine treatment regimen in minority patients with Stage 2 hypertension.|Baseline and week 8|Analysis was based on the Full Analysis Set consisting of all patients to whom study medication had been assigned. Last-observation-carried-forward was used. Baseline was not carried forward. In the Aliskiren/Amlodipine/HCTZ group, 5 patients did not have a post baseline measure. Hence, change from baseline to week 8 is reported for 197 patients.||mmHg||Standard Deviation|Mean
797621|NCT00943072|Secondary|Change From Baseline in the NEI VFQ-25 in Total Score at Week 24 (LOCF)|The NEI VFQ-25 assesses visual function and quality of life. Total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales which are all scored from 0-100. To reach the overall composite score, each sub-scale score is averaged in order to give each sub-scale equal weight.|Baseline and at Week 24|||scores on a scale||Standard Deviation|Mean
797622|NCT00943072|Secondary|Percentage of Participants Progressing to Any of the Following: Anterior Segment Neovascularization, New Vessels of the Disc (NVD) or New Vessels Elsewhere (NVE) During the First 24 Weeks||Baseline to Week 24|Full Analysis Set||percentage of participants|||Number
797623|NCT00943072|Secondary|Change From Baseline in Central Retinal Thickness (CRT) at Week 24 - LOCF||Baseline and at Week 24|Full Analysis Set||microns||Standard Deviation|Mean
797624|NCT00943072|Secondary|Change From Baseline in BCVA as Measured by ETDRS Letter Score at Week 24 - Last Observation Carried Forward (LOCF)|Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 24 (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning.|Baseline and at Week 24|Full Analysis Set||letters correctly read||Standard Deviation|Mean
797625|NCT00943072|Primary|Percentage of Participants Who Gained at Least 15 Letters in BCVA at Week 24 as Measured by ETDRS Letter Score|"Percentage values indicate the number of subjects in each arm who were able to read an additional 15 letters or more at Week 24 compared to baseline.
Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 24 letters (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning."|Baseline and at Week 24|Full Analysis Set||percentage of participants|||Number
797626|NCT00943098|Primary|Pain Intensity Difference (PID)|Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assessed by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).|1.5 hours|Analysed patients are those included in the ITT population: defined as all randomised patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose.||mm||95% Confidence Interval|Least Squares Mean
797627|NCT00943098|Secondary|PIDs||at 8 hours post-dose.|Analysed patients were included in the ITT population: all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint).||mm||Standard Deviation|Mean
797628|NCT00943098|Secondary|PIDs||at 7 hours post-dose.|Analysed patients were included in the ITT population: all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint).||mm||Standard Deviation|Mean
797629|NCT00943098|Secondary|PIDs||at 6 hours post-dose.|Analysed patients were included in the ITT population: all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint).||mm||Standard Deviation|Mean
797630|NCT00943098|Secondary|PIDs||at 5 hours post-dose.|Analysed patients were included in the ITT population: all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint).||mm||Standard Deviation|Mean
797631|NCT00943098|Secondary|PIDs||at 4 hours post-dose.|Analysed patients were included in the ITT population: all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint).||mm||Standard Deviation|Mean
797633|NCT00943098|Secondary|PIDs||at 2 hours post-dose.|Analysed patients were included in the ITT population: all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint).||mm||Standard Deviation|Mean
797634|NCT00943098|Secondary|PIDs||at 90 minutes post-dose.|Analysed patients were included in the ITT population: all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint).||mm||Standard Deviation|Mean
797635|NCT00943098|Secondary|PIDs||at 60 minutes post-dose.|Analysed patients were included in the ITT population: all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint).||mm||Standard Deviation|Mean
797636|NCT00943098|Secondary|PIDs||at 45 minutes post-dose.|Analysed patients were included in the ITT population: all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint).||mm||Standard Deviation|Mean
797637|NCT00943098|Secondary|PIDs||at 30 minutes post-dose.|Analysed patients were included in the ITT population: all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint).||mm||Standard Deviation|Mean
797638|NCT00943098|Secondary|PIDs||at 15 minutes post-dose.|Analysed patients were included in the ITT population: all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint).||mm||Standard Deviation|Mean
797639|NCT00943098|Primary|Pain Intensity Difference (PID)|Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assessed by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).|1.5 hours|Analysed patients are those included in the PP population: all patients included in the ITT population who also met all inclusion/exclusion criteria and who did not have any major protocol violation, and with post-surgical pain assessment at the primary endpoint.||mm||95% Confidence Interval|Least Squares Mean
797640|NCT00943111|Secondary|Percent Change From Baseline in Liver Volume (in MN) at Week 208|Percent change in liver volume = ([liver volume at Week 208 minus liver volume at baseline] divided by [liver volume at baseline]) multiplied by 100, where all volumes are in multiples of normal.|Baseline, Week 208|FAS population for LTTP. Number of participants analyzed = participants with both baseline and Week 208 liver volume assessment.||percent change||Standard Deviation|Mean
797641|NCT00943111|Secondary|Percent Change From Baseline in Spleen Volume (in MN) at Week 208|Percent change in spleen volume = ([spleen volume at Week 208 minus spleen volume at baseline] divided by [spleen volume at baseline]) multiplied by 100, where all volumes are in MN.|Baseline, Week 208|FAS population for LTTP. Number of participants analyzed = participants with both baseline and Week 208 spleen volume assessment.||percent change||Standard Deviation|Mean
797642|NCT00943111|Secondary|Percent Change From Baseline in Platelet Counts at Week 208|Percent change in platelet counts = ([platelet count at Week 208 minus platelet count at baseline] divided by [platelet count at baseline]) multiplied by 100.|Baseline, Week 208|FAS population for LTTP. Number of participants analyzed = participants with both baseline and Week 208 platelet assessment.||percent change||Standard Deviation|Mean
797643|NCT00943111|Secondary|Absolute Change From Baseline in Hemoglobin Levels at Week 208|Absolute change = hemoglobin level at Week 208 minus hemoglobin level at baseline.|Baseline, Week 208|FAS population for LTTP. Number of participants analyzed = participants with both baseline and Week 208 hemoglobin assessment.||g/dL||Standard Deviation|Mean
797644|NCT00943111|Secondary|Absolute Change From Baseline in Total Z-Scores for Bone Mineral Density at Week 208|Images of the spine and bilateral femur were obtained by DXA to determine Z-score for each bone area and total bone mineral density. The Z-score bone density categories are: normal (score >-2) and below normal (score <=-2). Absolute change = Z-score at Week 208 minus Z-score at baseline.|Baseline, Week 208|FAS population for LTTP. Number of participants analyzed = participants with both baseline and Week 208 Z-score assessment. Here, 'n' signifies participants with both baseline and Week 208 Z-score assessment for specified bone area.||Z-score||Standard Deviation|Mean
797645|NCT00943111|Secondary|Absolute Change From Baseline in Total T-Scores for Bone Mineral Density at Week 208|Images of the spine and bilateral femur were obtained by DXA to determine T-score for each bone area and total bone mineral density. T-score compares participant's bone density with that of healthy young participant. The T-score bone density categories are: normal (score >-1), osteopenia (score -2.5 to <=-1), and osteoporosis (score <= -2.5). Absolute change = T-score at Week 208 minus T-score at baseline.|Baseline, Week 208|Number of participants analyzed = participants with both baseline and Week 208 T-score assessment.||T-Score||Standard Deviation|Mean
797646|NCT00943111|Secondary|Percent Change From Baseline in Liver Volume (in MN) at Week 52|Percent change in liver volume = ([liver volume at Week 52 minus liver volume at baseline] divided by [liver volume at baseline]) multiplied by 100, where all volumes are in multiples of normal.|Baseline, Week 52|Per protocol population for PAP. Number of participants analyzed = participants with both baseline and Week 52 liver volume assessment. Eliglustat participants switching to imiglucerase were excluded.||percent change||Standard Error|Least Squares Mean
797647|NCT00943111|Secondary|Percent Change From Baseline in Spleen Volume (MN) at Week 52|Percent change in spleen volume = ([spleen volume at Week 52 minus spleen volume at baseline] divided by [spleen volume at baseline]) multiplied by 100, where all volumes are in MN.|Baseline, Week 52|Per protocol population for PAP. Number of participants analyzed = participants with both baseline and Week 52 spleen volume assessment. Eliglustat participants switching to imiglucerase were excluded.||percent change||Standard Error|Least Squares Mean
797648|NCT00943111|Secondary|Percent Change From Baseline in Platelet Counts at Week 52|Percent change in platelet counts = ([platelet count at Week 52 minus platelet count at baseline] divided by [platelet count at baseline]) multiplied by 100.|Baseline, Week 52|Per protocol population for PAP. Number of participants analyzed = participants with both baseline and Week 52 platelet assessment. Eliglustat participants switching to imiglucerase were excluded.||percent change||Standard Error|Least Squares Mean
797649|NCT00943111|Secondary|Absolute Change From Baseline in Hemoglobin Levels at Week 52|Absolute change = hemoglobin level at Week 52 minus hemoglobin level at baseline.|Baseline, Week 52|Per protocol population for PAP. Number of participants analyzed = participants with both baseline and Week 52 hemoglobin assessment. Eliglustat participants switching to imiglucerase were excluded.||g/dL||Standard Error|Least Squares Mean
797651|NCT00943111|Secondary|Absolute Change From Baseline in Total Z-Scores for Bone Mineral Density at Week 52|Images of the spine and bilateral femur were obtained by DXA to determine Z-score for each bone area and total bone mineral density. The Z-score bone density categories are: normal (score >-2) and below normal (score <=-2). Absolute change = Z-score at Week 52 minus Z-score at baseline.|Baseline, Week 52|Per protocol population for PAP. Number of participants analyzed = participants with both baseline and Week 52 Z-score assessment. Here, 'n' signifies participants with both baseline and Week 52 Z-score assessment for specified bone area. Eliglustat participants switching to imiglucerase were excluded.||Z-score||Standard Error|Least Squares Mean
797652|NCT00943111|Secondary|Total Z-Scores for Bone Mineral Density|Images of the spine and bilateral femur were obtained by DXA to determine Z-score for each bone area and total bone mineral density. The Z-score bone density categories are: normal (score >-2) and below normal (score <=-2).|Baseline|Per protocol population for PAP. Number of participants analyzed = participants with baseline Z-score assessment. Here, 'n' signifies participants with baseline Z-score assessment for specified bone area.||Z-score||Standard Deviation|Mean
797653|NCT00943111|Secondary|Absolute Change From Baseline in Total T-Scores for Bone Mineral Density at Week 52|Images of the spine and bilateral femur were obtained by DXA to determine T-score for each bone area and total bone mineral density. T-score compares participant’s bone density with that of healthy young participant. The T-score bone density categories are: normal (score >-1), osteopenia (score -2.5 to <=-1), and osteoporosis (score <= -2.5). Absolute change = T-score at Week 52 minus T-score at baseline.|Baseline, Week 52|Per protocol population for PAP. Number of participants analyzed = participants with both baseline and Week 52 T-score assessment. Here, 'n' signifies participants with both baseline and Week 52 T-score assessment for specified bone area. Eliglustat participants switching to imiglucerase were excluded.||T-score||Standard Error|Least Squares Mean
797654|NCT00943111|Secondary|Total T-Scores for Bone Mineral Density|Images of the spine and bilateral femur were obtained by dual energy X-Ray absorptiometry (DXA) to determine T-score for each bone area and total bone mineral density. T-score compares participant’s bone density with that of healthy young participant. The T-score bone density categories are: normal (score greater than [>]-1), osteopenia (score -2.5 to less than or equal to [<=] -1), and osteoporosis (score <= -2.5).|Baseline|Per protocol population for PAP. Number of participants analyzed = participants with baseline T-score assessment. Here, 'n' signifies participants with baseline T-score assessment for specified bone area.||T-score||Standard Deviation|Mean
797655|NCT00943111|Primary|Percentage of Participants Who Remained Stable Annually for 4 Years During the LTTP|For a participant to be classified as stable, the participant must have remained stable in hematological parameters (hemoglobin levels and platelet counts) and organ volumes (spleen, when applicable, and liver volumes in MN). Stable hematological parameters were defined as hemoglobin level did not decrease >1.5 g/dL from baseline and platelet count did not decrease >25% from baseline. Stable organ volumes were defined as spleen volume (in MN) did not increase >25% from baseline, if applicable, and liver volume did not increase >20% from baseline.|Week 52 up to week 208|FAS population for LTTP: included all participants who received at least 1 dose of eliglustat in the extension study period. Number of participants analyzed=participants at risk at specified time-points. Here 'n' signifies number of participants with available data for specified time-points.||percentage of participants|||Number
797656|NCT00943111|Primary|Percentage of Participants Who Remained Stable for 52 Weeks During the Primary Analysis Period|For a participant to be classified as stable, the participant must have remained stable in hematological parameters (hemoglobin levels and platelet counts) and organ volumes (spleen, when applicable, and liver volumes in multiples of normal [MN]). Stable hematological parameters were defined as hemoglobin level did not decrease more than (>) 1.5 gram per deciliter (g/dL) from baseline and platelet count did not decrease >25% from baseline. Stable organ volumes were defined as spleen volume (in MN) did not increase >25% from baseline, if applicable, and liver volume (in MN) did not increase >20% from baseline.|Baseline up to Week 52|Per protocol population for PAP included participants who were at least 80% compliant with treatment during PAP, had no major protocol deviations, and did not exhibit hematological decline as a result of medically determined etiologies other than Gaucher disease.||percentage of participants||95% Confidence Interval|Number
797657|NCT00943124|Primary|Total Urinary Excretion of Niacin and Its Metabolites||96 Hours Post Dose|Two hundred-twenty (220) subjects were enrolled in this study. Due to early dropout (N=4), data from a total of 216 subjects were available for both MK0524B and Simvastatin + MK0524A for analysis of urinary excretion of nicotinuric acid and metabolites||µmol||Standard Deviation|Least Squares Mean
797658|NCT00943124|Primary|Peak Plasma Concentration (Cmax) of Nicotinuric Acid|Peak Plasma Concentration (Cmax) for Nicotinuric Acid, one of the active metabolites of Niacin|24 Hours Post Dose|Two hundred-twenty (220) subjects were enrolled in this study. Due to early dropout (N=4) and missing samples (N=1), data from a total of 215 and 216 subjects available for plasma nicotinuric acid analysis for MK0524B and Simvastatin + MK0524A, respectively.||ng/mL||Standard Deviation|Least Squares Mean
797659|NCT00943124|Primary|Peak Plasma Concentration (Cmax) of Laropiprant||48 Hours Post Dose|Two hundred-twenty (220) subjects were enrolled in this study. Due to early dropout (N=4), data from a total of 217 and 216 subjects were available for laropiprant Cmax analysis for MK0524B and Simvastatin + MK0524A, respectively||nmol/L||Standard Deviation|Least Squares Mean
797660|NCT00943124|Primary|Plasma Area Under the Curve (AUC(0 to Infinity)) for Laropiprant|Plasma Area Under the Curve of Laropiprant|48 Hours Post Dose|Two hundred-twenty (220) subjects were enrolled in this study. Due to early dropout (N=4), data from a total of 217 and 216 subjects were available for laropiprant AUC(0 to infinity) analysis for MK0524B and Simvastatin + MK0524A, respectively||nmol/L * hour||Standard Deviation|Least Squares Mean
797661|NCT00943124|Primary|Peak Plasma Concentration (Cmax) of Simvastatin||48 Hours Post Dose|Two hundred-twenty (220) subjects were enrolled in this study. Due to early dropout (N=4), mis-handling of plasma samples (N=2) and the limitation of the assay (N=10), data from a total of 209 and 210 subjects were available for simvastatin Cmax analysis for MK0524B and Simvastatin + MK0524A, respectively.||ng/mL||Standard Deviation|Least Squares Mean
797662|NCT00943124|Primary|Plasma Area Under the Curve (AUC(0 to 48 Hour)) for Simvastatin|Plasma Area Under the Curve of simvastatin|Through 48 Hours Post Dose|Two hundred-twenty (220) subjects were enrolled in this study. Due to early dropout (N=4), mis-handling of plasma samples (N=2) and the limitation of the assay (N=10), data from a total of 208 and 210 subjects were available for simvastatin AUC(0-48 hour) analysis for MK0524B and Simvastatin + MK0524A, respectively.||ng/mL * Hour||Standard Deviation|Least Squares Mean
797663|NCT00943124|Primary|Peak Plasma Concentration (Cmax) of Simvastatin Acid|Peak Plasma Concentration (Cmax) for Simvastatin Acid, the active metabolite of simvastatin|48 Hours Post Dose|Two hundred-twenty (220) subjects were enrolled in this study. Due to early dropout (N=4), mis-handling of plasma samples (N=10) and the limitation of the assay (N=10), data from a total of 201 and 202 subjects were available for simvastatin acid Cmax analysis for MK0524B and Simvastatin + MK0524A, respectively.||ng/mL||Standard Deviation|Least Squares Mean
797664|NCT00943124|Primary|Plasma Area Under the Curve (AUC(0 to 48hr)) for Simvastatin Acid|Plasma Area Under the Curve of simvastatin acid, the active metabolite of simvastatin|Through 48 Hours Post Dose|Two hundred-twenty (220) subjects were enrolled in this study. Due to early dropout (N=4), mis-handling of plasma samples (N=10) and the limitation of the assay (N=10), data from a total of 200 and 202 subjects were available for simvastatin acid AUC(0 to 48 hour) analysis for MK0524B and Simvastatin + MK0524A, respectively.||ng/mL * Hour||Standard Deviation|Least Squares Mean
797665|NCT00943150|Secondary|Diet Volume|Sum of diet volume (i.e., how much food the subject ate) over 10 days postoperatively using a 0 (0% of normal) to 100 (100% of normal) visual analog scale. Subjects circled a number representing their diet volume by tens (e.g., 10% of normal, 20% of normal). Subjects completed the scale daily through day 10. The results represent the mean cumulative value per patient.|Postoperative (0 to 10 days)|One subject was removed from the analysis of secondary variables owing to a protocol deviation.||units on a scale||Standard Deviation|Mean
797666|NCT00943150|Secondary|Activity Level|Sum of activity over 10 days postoperatively using a 0 (0% of normal) to 100 (100% of normal) visual analog scale. Subjects circled a number representing their activity level by tens (e.g., 10% of normal, 20% of normal). Subjects completed the scale daily through day 10. The results represent the mean cumulative value per patient.|Postoperative (0 to 10 days)|One subject was removed from the analysis of secondary variables owing to a protocol deviation.||units on a scale||Standard Deviation|Mean
797667|NCT00943150|Secondary|Postoperative Pain Levels|Wong-Baker FACES Visual Analog Scale, 0 (no hurt) to 10 (hurts worst). The results represent the mean of each subject's mean pain scores over 10 days.|Postoperative (0 to 10 days)|One subject was removed from the analysis of secondary variables owing to a protocol deviation.||units on a scale||Standard Deviation|Mean
797668|NCT00943150|Secondary|Narcotic Consumption|Narcotic medications were coded to Fentanyl microgram equivalent units per kilogram.|Intraoperative and postoperative (0 to 10 days)|One subject was removed from the analysis of secondary variables owing to a protocol deviation.||Fentanyl microgram units/g||Standard Deviation|Mean
797669|NCT00943150|Secondary|Change in Hemoglobin|The outcome measure is reported as change in hemoglobin, not the hemoglobin value itself.|Intraoperative|One subject was removed from the analysis of secondary variables owing to a protocol deviation.||g/dL||Standard Deviation|Mean
797670|NCT00943150|Secondary|Total Drainage Output||0 to 10 days postoperatively|One subject was removed from the analysis of secondary variables owing to a protocol deviation.||mL||Standard Deviation|Mean
797671|NCT00943150|Primary|Inflammatory Cell Count|Histological samples were created by first incising the area to be resected with all 3 modalities (PEAK PlasmaBlade, electrocautery, and scalpel) at 6 and 3 weeks before the operation. Then, the incised tissue was resected during the abdominoplasty and was assessed by analyzing incisions created in the resected area for histological measures.|0, 3, and 6 weeks|||cells per square millimeter||Standard Deviation|Mean
797672|NCT00943150|Primary|Acute Thermal Injury Depth|"Histological samples were created by first incising the area to be resected with all 3 modalities (PEAK PlasmaBlade, electrocautery, and scalpel) at 6 and 3 weeks before the operation. Then, the incised tissue was resected during the abdominoplasty and was assessed by analyzing incisions created in the resected area for histological measures.
Acute thermal injury depth was assessed by incising the resected area during the abdominoplasty operation."|Immediately postoperative|||micrometers||Standard Deviation|Mean
797673|NCT00943202|Secondary|Number of Participants Age 10 to 17 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more. Day 21 post second H1N1 vaccination is study Day 63 for Group 4, and is study Day 42 for all other groups.|Day 0 prior to first vaccination and 21 days after the second H1N1 vaccination|Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
797674|NCT00943202|Secondary|Number of Participants Age 36 Months to 9 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more. Day 21 post second H1N1 vaccination is study Day 63 for Group 4, and is study Day 42 for all other groups.|Day 0 prior to first vaccination and 21 days after the second H1N1 vaccination|Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. One participant was excluded due to receipt of a non-study vaccine and one due to Influenza-like illness. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
797690|NCT00943202|Primary|Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Quantitative Local Reactions After the Second H1N1 Vaccination|Participants' parents/guardians maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days. Second H1N1 vaccination was given on Study Day 21 for Groups 1, 2 and 3, and on Study Day 42 for Group 4.|Within 8 days (Day 0-7) post second H1N1 vaccination|All participants receiving the second H1N1 vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
797675|NCT00943202|Secondary|Number of Participants Age 6 to Less Than 36 Months With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more. Day 21 post second H1N1 vaccination is study Day 63 for Group 4, and is study Day 42 for all other groups.|Day 0 prior to first vaccination and 21 days after the second H1N1 vaccination|Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. One participant was excluded due to receipt of a non-study vaccine and one due to Influenza-like illness. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
797676|NCT00943202|Secondary|Number of Participants Age 10 to 17 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. For Group 4, 21 days after second H1N1 vaccination is study Day 63, all others it is study Day 42. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the second H1N1 vaccination|Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. This outcome restricts to age stratum.||Participants|||Number
797677|NCT00943202|Secondary|Number of Participants Age 36 Months to 9 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. For Group 4, 21 days after second H1N1 vaccination is study Day 63, all others it is study Day 42. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the second H1N1 vaccination|Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. One participant was excluded due to receipt of a non-study vaccine and one due to Influenza-like illness. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
797678|NCT00943202|Secondary|Number of Participants Age 6 to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. For Group 4, 21 days after second H1N1 vaccination is study Day 63, all others it is study Day 42. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the second H1N1 vaccination|Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. One participant was excluded due to receipt of a non-study vaccine and one due to Influenza-like illness. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
797679|NCT00943202|Secondary|Number of Participants Age 10 to 17 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination|Blood was collected from participants 21 days after the last vaccination for testing in the HAI assay against each strain in the 2009-2010 trivalent influenza vaccine. Each sample was tested according to standard operating procedures. A participant is counted if the value at the Day 63 timepoint was 1:40 or greater. Day 21 after last vaccination is study Day 63 for Groups 1 and 4, and study Day 42 for Groups 2 and 3.|Day 21 after last vaccination|Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
797680|NCT00943202|Secondary|Number of Participants Age 36 Months to 9 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination|Blood was collected from participants 21 days after the last vaccination for testing in the HAI assay against each strain in the 2009-2010 trivalent influenza vaccine. Each sample was tested according to standard operating procedures. A participant is counted if the value at the Day 63 timepoint was 1:40 or greater. Day 21 after last vaccination is study Day 63 for Groups 1 and 4, and study Day 42 for Groups 2 and 3.|Day 21 after last vaccination|Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. One participant was excluded due to receipt of non-study vaccine, 3 due to Influenza-like illness, and 1 due to H1N1 infection. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
797681|NCT00943202|Primary|Number of Participants Age 10 to 17 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. For Group 4, this timepoint is Study Day 42, all others it is Study Day 21. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after first H1N1 vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint, both within 4 days of the window, are included. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
797733|NCT00935220|Secondary|DPP-4 Inhibition: E_24|Plasma DPP-4 inhibition 24 hours after first dose. Plasma DPP-4 inhibition is derived by calculating (1-(activity in presence of linagliptin)/baseline activity))*100%, where 'activity' is the activity of the DPP-IV enzyme.|One single measurement 24 h after drug administration|Treated set||Percent (of inhibition)||Full Range|Median
797682|NCT00943202|Primary|Number of Participants Age 36 Months to 9 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. For Group 4, this timepoint is Study Day 42, all others it is Study Day 21. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after first H1N1 vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint, both within 4 days of the window, are included. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
797683|NCT00943202|Primary|Number of Participants Age 6 Months to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. For Group 4, this timepoint is Study Day 42, all others it is Study Day 21. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after first H1N1 vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint, both within 4 days of the window, are included. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
797684|NCT00943202|Primary|Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)|Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof; resulted in a congenital anomaly/birth defect; may have jeopardized the participant or required intervention to prevent one of these outcomes; or was described as Guillain-Barré Syndrome. Association to vaccination was determined by a study clinician licensed to make medical diagnoses.|Day 0 through 180 days after the last vaccination|All participants receiving at least one vaccination are included in the safety cohort. Analyses are as treated.||Participants|||Number
797685|NCT00943202|Primary|Number of Participants Age 10 to 17 Years Reporting Solicited Quantitative Local Reactions After the TIV Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days. The TIV vaccination was given on Study Day 42 for Group 1, Study Day 0 for Groups 2 and 4, and on Study Day 21 for Group 3.|Within 8 days (Day 0-7) post TIV vaccination|All participants receiving the TIV vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
797686|NCT00943202|Primary|Number of Participants Age 36 Months to 9 Years Reporting Solicited Quantitative Local Reactions After the TIV Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days. The TIV vaccination was given on Study Day 42 for Group 1, Study Day 0 for Groups 2 and 4, and on Study Day 21 for Group 3.|Within 8 days (Day 0-7) post TIV vaccination|All participants receiving the TIV vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
797687|NCT00943202|Primary|Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Quantitative Local Reactions After the TIV Vaccination|Participants' parents/guardians maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days. The TIV vaccination was given on Study Day 42 for Group 1, Study Day 0 for Groups 2 and 4, and on Study Day 21 for Group 3.|Within 8 days (Day 0-7) post TIV vaccination|All participants receiving the TIV vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
797688|NCT00943202|Primary|Number of Participants Age 10 to 17 Years Reporting Solicited Quantitative Local Reactions After the Second H1N1 Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days. Second H1N1 vaccination was given on Study Day 21 for Groups 1, 2 and 3, and on Study Day 42 for Group 4.|Within 8 days (Day 0-7) post second H1N1 vaccination|All participants receiving the second H1N1 vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
797689|NCT00943202|Primary|Number of Participants Age 36 Months to 9 Years Reporting Solicited Quantitative Local Reactions After the Second H1N1 Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days. Second H1N1 vaccination was given on Study Day 21 for Groups 1, 2 and 3, and on Study Day 42 for Group 4.|Within 8 days (Day 0-7) post second H1N1 vaccination|All participants receiving the second H1N1 vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
797734|NCT00935220|Secondary|Linagliptin: C_max|maximum concentration of linagliptin in plasma on Day 1|24h|Treated set - All patients with values for the maximum measured concentration of linagliptin in plasma (C_max)||nmol/L||Geometric Coefficient of Variation|Geometric Mean
799487|NCT00947791|Primary|Montgomery-Asberg Depression Rating Scale (MADRS)||24 hrs post-infusion compared to baseline|Based on confidentiality concerns, 0 participants analyzed.|||||
797691|NCT00943202|Primary|Number of Participants Age 10 to 17 Years Reporting Solicited Quantitative Local Reactions After the First H1N1 Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days. First H1N1 vaccination was given on Study Day 0 for Groups 1, 2 and 3, and on Study Day 21 for Group 4.|Within 8 days (Day 0-7) post first H1N1 vaccination|All participants receiving the first H1N1 vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
797692|NCT00943202|Primary|Number of Participants Age 36 Months to 9 Years Reporting Solicited Quantitative Local Reactions After the First H1N1 Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days. First H1N1 vaccination was given on Study Day 0 for Groups 1, 2 and 3, and on Study Day 21 for Group 4.|Within 8 days (Day 0-7) post first H1N1 vaccination|All participants receiving the first H1N1 vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
797693|NCT00943202|Primary|Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Quantitative Local Reactions After the First H1N1 Vaccination|Participants' parents/guardians maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days. First H1N1 vaccination was given on Study Day 0 for Groups 1, 2 and 3, and on Study Day 21 for Group 4.|Within 8 days (Day 0-7) post first H1N1 vaccination|All participants receiving the first H1N1 vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
797694|NCT00943202|Primary|Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Local Reactions After the TIV Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days. The TIV vaccination was given on Study Day 42 for Group 1, Study Day 0 for Groups 2 and 4, and on Study Day 21 for Group 3.|Within 8 days (Day 0-7) post TIV vaccination|All participants receiving the TIV vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
797695|NCT00943202|Primary|Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Local Reactions After the TIV Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days. The TIV vaccination was given on Study Day 42 for Group 1, Study Day 0 for Groups 2 and 4, and on Study Day 21 for Group 3.|Within 8 days (Day 0-7) post TIV vaccination|All participants receiving the TIV vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
797696|NCT00943202|Primary|Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Local Reactions After the TIV Vaccination|Participants' parents/guardians maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days. The TIV vaccination was given on Study Day 42 for Group 1, Study Day 0 for Groups 2 and 4, and on Study Day 21 for Group 3.|Within 8 days (Day 0-7) post TIV vaccination|All participants receiving the TIV vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
797697|NCT00943202|Primary|Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Local Reactions After the Second H1N1 Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days. Second H1N1 vaccination was given on Study Day 21 for Groups 1, 2 and 3, and on Study Day 42 for Group 4.|Within 8 days (Day 0-7) post second H1N1 vaccination|All participants receiving the second H1N1 vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
797698|NCT00943202|Primary|Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Local Reactions After the Second H1N1 Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days. Second H1N1 vaccination was given on Study Day 21 for Groups 1, 2 and 3, and on Study Day 42 for Group 4.|Within 8 days (Day 0-7) post second H1N1 vaccination|All participants receiving the second H1N1 vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
797735|NCT00935220|Primary|DPP-4 Inhibition: E_24,ss|Plasma DPP-4 inhibition at trough under steady state conditions. Plasma DPP-4 inhibition is derived by calculating (1-(activity in presence of linagliptin)/baseline activity))*100%, where 'activity' is the activity of the DPP-IV enzyme.|One single measurement 24 h after drug administration under steady state conditions|Treated set||Percent (of inhibition)||Full Range|Median
798592|NCT00949078|Primary|Number of Participants Who Experienced a Decrease in Pn-BHR Area Under the Curve (AUC) of > 80% Compared With Baseline Values Before Week 8|Presence or absence of this change|up to 6 months|||Participants|||Count of Participants
797699|NCT00943202|Primary|Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Local Reactions After the Second H1N1 Vaccination|Participants' parents/guardians maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days. Second H1N1 vaccination was given on Study Day 21 for Groups 1, 2 and 3, and on Study Day 42 for Group 4.|Within 8 days (Day 0-7) post second H1N1 vaccination|All participants receiving the second H1N1 vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
797700|NCT00943202|Primary|Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Local Reactions After the First H1N1 Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days. First H1N1 vaccination was given on Study Day 0 for Groups 1, 2 and 3, and on Study Day 21 for Group 4.|Within 8 days (Day 0-7) post first H1N1 vaccination|All participants receiving the first H1N1 vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
797701|NCT00943202|Primary|Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Local Reactions After the First H1N1 Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days. First H1N1 vaccination was given on Study Day 0 for Groups 1, 2 and 3, and on Study Day 21 for Group 4.|Within 8 days (Day 0-7) post first H1N1 vaccination|All participants receiving the first H1N1 vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
797702|NCT00943202|Primary|Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Local Reactions After the First H1N1 Vaccination|Participants' parents/guardians maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days. First H1N1 vaccination was given on Study Day 0 for Groups 1, 2 and 3, and on Study Day 21 for Group 4.|Within 8 days (Day 0-7) post first H1N1 vaccination|All participants receiving the first H1N1 vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
797703|NCT00943202|Primary|Number of Participants Age 10 to 17 Years Reporting Solicited Quantitative Systemic Reactions After the Third Vaccination|Participants or their parents/guardians maintained a memory aid to record daily oral/axillary temperatures and the number of vomiting episodes, if experienced, for 8 days after vaccination (Day 0-7). Participants are counted as experiencing fever if they reported oral temperatures of 38.3 degrees Celsius or higher, or axillary temperatures of 37.8 degrees Celsius or higher, on any of the 8 days. Participants are counted as experiencing vomiting if they reported one or more episodes of vomiting on any of the 8 days. Groups 1 and 4 only had a third vaccination day.|Within 8 days (Day 0-7) post third vaccination|All participants receiving the third vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
797704|NCT00943202|Primary|Number of Participants Age 36 Months to 9 Years Reporting Solicited Quantitative Systemic Reactions After the Third Vaccination|Participants or their parents/guardians maintained a memory aid to record daily oral/axillary temperatures and the number of vomiting episodes, if experienced, for 8 days after vaccination (Day 0-7). Participants are counted as experiencing fever if they reported oral temperatures of 38.3 degrees Celsius or higher, or axillary temperatures of 37.8 degrees Celsius or higher, on any of the 8 days. Participants are counted as experiencing vomiting if they reported one or more episodes of vomiting on any of the 8 days. Groups 1 and 4 only had a third vaccination day.|Within 8 days (Day 0-7) post third vaccination|All participants receiving the third vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
797705|NCT00943202|Primary|Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Quantitative Systemic Reactions After the Third Vaccination|Participants' parents/guardians maintained a memory aid to record daily oral/axillary temperatures and the number of vomiting episodes, if experienced, for 8 days after vaccination (Day 0-7). Participants are counted as experiencing fever if they reported oral temperatures of 38.3 degrees Celsius or higher, or axillary temperatures of 37.8 degrees Celsius or higher, on any of the 8 days. Participants are counted as experiencing vomiting if they reported one or more episodes of vomiting on any of the 8 days. Groups 1 and 4 only had a third vaccination day.|Within 8 days (Day 0-7) post third vaccination|All participants receiving the third vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
797706|NCT00943202|Primary|Number of Participants Age 10 to 17 Years Reporting Solicited Quantitative Systemic Reactions After the Second Vaccination|Participants or their parents/guardians maintained a memory aid to record daily oral/axillary temperatures and the number of vomiting episodes, if experienced, for 8 days after vaccination (Day 0-7). Participants are counted as experiencing fever if they reported oral temperatures of 38.3 degrees Celsius or higher, or axillary temperatures of 37.8 degrees Celsius or higher, on any of the 8 days. Participants are counted as experiencing vomiting if they reported one or more episodes of vomiting on any of the 8 days.|Within 8 days (Day 0-7) post second vaccination|All participants receiving the second vaccination are included in the safety cohort. One Group 3 participant did not report temperatures. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
797736|NCT00935220|Secondary|Linagliptin: AUC_0-24|area under the concentration time curve of linagliptin in plasma over the time interval from 0 to 24h after administration of the first dose|24 hours|Treated set- All patients with values for the area under the concentration time curve of the analyte in plasma over the time interval from 0 to 24 h after administration of the first dose (AUC_0-24) for Linagliptin||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
797707|NCT00943202|Primary|Number of Participants Age 36 Months to 9 Years Reporting Solicited Quantitative Systemic Reactions After the Second Vaccination|Participants or their parents/guardians maintained a memory aid to record daily oral/axillary temperatures and the number of vomiting episodes, if experienced, for 8 days after vaccination (Day 0-7). Participants are counted as experiencing fever if they reported oral temperatures of 38.3 degrees Celsius or higher, or axillary temperatures of 37.8 degrees Celsius or higher, on any of the 8 days. Participants are counted as experiencing vomiting if they reported one or more episodes of vomiting on any of the 8 days.|Within 8 days (Day 0-7) post second vaccination|All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
797708|NCT00943202|Primary|Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Quantitative Systemic Reactions After the Second Vaccination|Participants' parents/guardians maintained a memory aid to record daily oral/axillary temperatures and the number of vomiting episodes, if experienced, for 8 days after vaccination (Day 0-7). Participants are counted as experiencing fever if they reported oral temperatures of 38.3 degrees Celsius or higher, or axillary temperatures of 37.8 degrees Celsius or higher, on any of the 8 days. Participants are counted as experiencing vomiting if they reported one or more episodes of vomiting on any of the 8 days.|Within 8 days (Day 0-7) post second vaccination|All participants receiving the second vaccination are included in the safety cohort. One Group 2 participant did not report temperatures. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
797709|NCT00943202|Primary|Number of Participants Age 10 to 17 Years Reporting Solicited Quantitative Systemic Reactions After the First Vaccination|Participants or their parents/guardians maintained a memory aid to record daily oral/axillary temperatures and the number of vomiting episodes, if experienced, for 8 days after vaccination (Day 0-7). Participants are counted as experiencing fever if they reported oral temperatures of 38.3 degrees Celsius or higher, or axillary temperatures of 37.8 degrees Celsius or higher, on any of the 8 days. Participants are counted as experiencing vomiting if they reported one or more episodes of vomiting on any of the 8 days.|Within 8 days (Day 0-7) post first vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
797710|NCT00943202|Primary|Number of Participants Age 36 Months to 9 Years Reporting Solicited Quantitative Systemic Reactions After the First Vaccination|Participants or their parents/guardians maintained a memory aid to record daily oral/axillary temperatures and the number of vomiting episodes, if experienced, for 8 days after vaccination (Day 0-7). Participants are counted as experiencing fever if they reported oral temperatures of 38.3 degrees Celsius or higher, or axillary temperatures of 37.8 degrees Celsius or higher, on any of the 8 days. Participants are counted as experiencing vomiting if they reported one or more episodes of vomiting on any of the 8 days.|Within 8 days (Day 0-7) post first vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
797711|NCT00943202|Primary|Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Quantitative Systemic Reactions After the First Vaccination|Participants' parents/guardians maintained a memory aid to record daily oral/axillary temperatures and the number of vomiting episodes, if experienced, for 8 days after vaccination (Day 0-7). Participants are counted as experiencing fever if they reported oral temperatures of 38.3 degrees Celsius or higher, or axillary temperatures of 37.8 degrees Celsius or higher, on any of the 8 days. Participants are counted as experiencing vomiting if they reported one or more episodes of vomiting on any of the 8 days.|Within 8 days (Day 0-7) post first vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
797712|NCT00943202|Primary|Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the Third Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, nausea and decreased general activity for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days. Groups 1 and 4 only had a third vaccination day.|Within 8 days (Day 0-7) post third vaccination|All participants receiving the third vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
797713|NCT00943202|Primary|Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Systemic Reactions After the Third Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, myalgia, headache, nausea and decreased general activity for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days. Groups 1 and 4 only had a third vaccination day.|Within 8 days (Day 0-7) post third vaccination|All participants receiving the third vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
797714|NCT00943202|Primary|Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Systemic Reactions After the Third Vaccination|Participants' parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of irritability, decreased appetite and lethargy for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days. Groups 1 and 4 only had a third vaccination day.|Within 8 days (Day 0-7) post third vaccination|All participants receiving the third vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
797737|NCT00935220|Secondary|Patients With Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities Reported as an Adverse Event|Patients with Electrocardiogram (ECG), vital signs, physical finding reported as an adverse event|21 days|All treated patients||Participants|||Number
797738|NCT00935220|Primary|Linagliptin: C_max,ss|maximum concentration of linagliptin in plasma at steady state|24 hours|Treated set||nmol/L||Geometric Coefficient of Variation|Geometric Mean
797715|NCT00943202|Primary|Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the Second Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, nausea and decreased general activity for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.|Within 8 days (Day 0-7) post second vaccination|All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
797716|NCT00943202|Primary|Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Systemic Reactions After the Second Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, myalgia, headache, nausea and decreased general activity for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.|Within 8 days (Day 0-7) post second vaccination|All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
797717|NCT00943202|Primary|Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Systemic Reactions After the Second Vaccination|Participants' parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of irritability, decreased appetite and lethargy for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.|Within 8 days (Day 0-7) post second vaccination|All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
797718|NCT00943202|Primary|Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the First Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, nausea and decreased general activity for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.|Within 8 days (Day 0-7) post first vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
797719|NCT00943202|Primary|Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Systemic Reactions After the First Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, myalgia, headache, nausea and decreased general activity for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.|Within 8 days (Day 0-7) post first vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
797720|NCT00943202|Secondary|Number of Participants Age 6 to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination|Blood was collected from participants 21 days after the last vaccination for testing in the HAI assay against each strain in the 2009-2010 trivalent influenza vaccine. Each sample was tested according to standard operating procedures. A participant is counted if the value at the Day 63 timepoint was 1:40 or greater. Day 21 after last vaccination is study Day 63 for Groups 1 and 4, and study Day 42 for Groups 2 and 3.|Day 21 after last vaccination|Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Two participants were excluded due to receipt of non-study vaccines and one due to Influenza-like illness. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
797721|NCT00943202|Secondary|Number of Participants Age 10 to 17 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination|Blood was collected from participants for testing in the HAI assay against each strain in the 2009-2010 trivalent influenza vaccine. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the titer at 21 days after last vaccination was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the titer at 21 days after last vaccination was an increase by 4-fold or more. Day 21 after last vaccination was study Day 63 for Groups 1 and 4, and study Day 42 for Groups 2 and 3.|Day 0 prior to first vaccination and Day 21 after last vaccination|Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
797722|NCT00943202|Secondary|Number of Participants Age 36 Months to 9 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination|Blood was collected from participants for testing in the HAI assay against each strain in the 2009-2010 trivalent influenza vaccine. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the titer at 21 days after last vaccination was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the titer at 21 days after last vaccination was an increase by 4-fold or more. Day 21 after last vaccination was study Day 63 for Groups 1 and 4, and study Day 42 for Groups 2 and 3.|Day 0 prior to first vaccination and Day 21 after last vaccination|Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. One participant was excluded due to receipt of non-study vaccine, 3 due to Influenza-like illness, and 1 due to H1N1 infection. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
797739|NCT00935220|Primary|Linagliptin: AUC_τ,ss|area under the concentration time curve (AUC_τ) of linagliptin in plasma at steady state over a uniform dosing interval|24 hours|Treated set||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
797723|NCT00943202|Secondary|Number of Participants Age 6 to Less Than 36 Months With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination|Blood was collected from participants for testing in the HAI assay against each strain in the 2009-2010 trivalent influenza vaccine. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the titer at 21 days after last vaccination was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the titer at 21 days after last vaccination was an increase by 4-fold or more. Day 21 after last vaccination was study Day 63 for Groups 1 and 4, and study Day 42 for Groups 2 and 3.|Day 0 prior to first vaccination and 21 days after last vaccination|Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Two participants were excluded due to receipt of non-study vaccines and one due to Influenza-like illness. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
797724|NCT00943202|Primary|Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Systemic Reactions After the First Vaccination|Participants' parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of irritability, decreased appetite and lethargy for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.|Within 8 days (Day 0-7) post first vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
797725|NCT00943202|Primary|Number of Participants Age 10 to 17 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more. Day 21 post first H1N1 vaccination is Study Day 42 for Group 4, and is Study Day 21 for all other groups.|Day 0 prior to vaccination and 21 days after the first H1N1 vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint, both within 4 days of the window, are included. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
797726|NCT00943202|Primary|Number of Participants Age 36 Months to 9 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more. Day 21 post first H1N1 vaccination is Study Day 42 for Group 4, and is Study Day 21 for all other groups.|Day 0 prior to vaccination and 21 days after the first H1N1 vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint, both within 4 days of the window, are included. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
797727|NCT00943202|Primary|Number of Participants Age 6 Months to Less Than 36 Months With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more. Day 21 post first H1N1 vaccination is Study Day 42 for Group 4, and is Study Day 21 for all other groups.|Day 0 prior to vaccination and 21 days after the first H1N1 vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint, both within 4 days of the window, are included. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
797728|NCT00935064|Primary|Expiration/Inspiration Ratio Before and After Treatment|Expiration/inspiration ratio at baseline and follow-up. There are several different assessment modalities used for the determination of cardiovascular autonomic function (i.e. HRV). One widely used clinical method for assessing HRV is RR-variation during deep breathing. RR-variation is a measure of the change in heart rate resulting from the variation in intrathoracic pressure due to respiration. It is predominantly a function of parasympathetic activity. In this study, RR-variation during deep breathing, performed for 6 min, was measured by vector analysis [i.e. mean circular resultant (MCR)] and by the expiration/inspiration (E/I) ratio of the first six breath cycles.|baseline and 6 weeks|||Ratio||Standard Deviation|Mean
797729|NCT00935064|Primary|Mean Circular Resultant Before and After Treatment|Mean circular resultant at baseline and follow-up. There are several different assessment modalities used for the determination of cardiovascular autonomic function (i.e. HRV). One widely used clinical method for assessing HRV is RR-variation during deep breathing. RR-variation is a measure of the change in heart rate resulting from the variation in intrathoracic pressure due to respiration. It is predominantly a function of parasympathetic activity. In this study, RR-variation during deep breathing, performed for 6 min, was measured by vector analysis [i.e. mean circular resultant (MCR)] and by the expiration/inspiration (E/I) ratio of the first six breath cycles. With regard to the MCR, the length of the vector mean is proportional to the degree of HRV. Weinberg and Pfeifer first introduced the assessment of HRV via determination of the MCR in a paper in Biometrics 1984:40:855-861. Low HRV is considered to be less favorable.|baseline and 6 weeks|||MCR is unitless||Standard Deviation|Mean
797730|NCT00935064|Primary|Serum Renin Level Before and After Treatment|Serum renin level at baseline and follow-up|baseline and 6 weeks|||ug/l/h||Standard Deviation|Mean
797731|NCT00935064|Primary|Diastolic Blood Pressure Before and After Treatment|Diastolic blood pressure at baseline and follow-up.|baseline and 6 weeks|||mm Hg||Standard Deviation|Mean
797732|NCT00935064|Primary|Systolic Blood Pressure Before and After Treatment|Systolic blood pressure at baseline and follow-up|baseline and 6 weeks|||mm Hg||Standard Deviation|Mean
797742|NCT00935259|Secondary|Change in Fasting Delta 5 Desaturase Enzyme Activity Compared to Placebo|Change in fasting delta 5 desaturase enzyme activity compared to placebo. Delta 5 desaturase enzyme activity is defined as the ratios of C20:4n-6 to C20:3n-6 and C20:5n-3 to C20:4n-3.|2 weeks|Only participants with complete fasting delta 5 desaturase enzyme activity data were included.||ratio||Standard Deviation|Mean
797743|NCT00935259|Secondary|Blood Linoleic Acid Levels|Change in blood linoleic acid levels for Cholesterol Ester compared to placebo.|2 weeks|Only participants with complete blood linoleic acid data were included.||nmol||Standard Deviation|Mean
797744|NCT00935259|Secondary|Serum Proprotein Convertase Subtilisin-like/Kexin Type 9 (PCSK9) Level|"Two days of standardized, pre-packaged meals were provided prior to the 10-hour fast required before blood collection. To assess how consumption of a meal would affect levels of plasma PCSK9, following each of the fasting blood draws, participants were asked to consume a high fat meal (heavy whipping cream + vanilla ice cream in a 1:4 ratio [dose = 162 g/m^2]) within 20 minutes. For the duration of the test, participants were to remain seated or recumbent until blood samples were drawn 4 h after meal completion.
The mean reported was an adjusted mean (defined in first outcome measure)."|2 weeks|Only participants with complete PCSK9 data were included.||nmol||Standard Deviation|Mean
797745|NCT00935259|Secondary|Fasting Blood Lipidomic Levels After 2 Weeks of Treatment|"Change in fasting blood cholesterol ester, lysophosphatidylcholine, phosphatidylcholine, phosphatidylethanolamine, and triacylglycerol levels compared to placebo.
The mean reported was an adjusted mean."|2 weeks|"Only participants with complete blood lipidomic data were included.
For cholesterol ester 22:5n6, n=26 for the simvastatin arm and n=27 for the placebo arm."||nmol||Standard Deviation|Mean
797746|NCT00935259|Primary|Arachidonic Acid Level After 2 Weeks of Treatment|"Arachidonic acid level (20:4n6) in the cholesterol ester lipid class.
The mean reported was an adjusted mean, which was obtained from running a 2-period crossover model that had fixed treatment and period terms and a random participant term."|2 weeks|Only participants with complete arachidonic acid data were included.||nmol||Standard Deviation|Mean
797747|NCT00935272|Secondary|Percentage of Participants With a Response|Assessment of lip fullness augmentation after treatment with Restylane, as compared to no treatment, at post-baseline time points as compared to baseline assessment. Response was determined by at least one grade improvement from baseline in the upper and lower lips using the Medicis Lip Fullness Scale (MLFS). The MLFS is a 5 number scale with grading: (1) Very Thin, (2) Thin (3) Medium (4) Full and (5)Very Full.|Baseline and at weeks 12, 16, 20 and 24|For this secondary objective, the pool of participants analyzed was based on 135 from the Intent to Treat population. However the analysis was done with the number of subjects with non-missing data. This number varied for each timepoint.||Percent of responders||95% Confidence Interval|Number
797748|NCT00935272|Primary|Percentage of Participants With Response|Assessment of lip fullness augmentation after treatment with Restylane, as compared to no treatment, at week 8 as compared to baseline assessment. Response was determined by at least one grade improvement from baseline in the upper and lower lips using the Medicis Lip Fullness Scale (MLFS). The MLFS is a 5 number scale with grading: (1) Very Thin, (2) Thin (3) Medium (4) Full and (5)Very Full.|Baseline and at 8 weeks|Analysis was ITT; Sample size based upon a one-sided Fisher's Exact test with alpha = 0.05; Subjects with a missing Blinded Evaluator assessment as Week 8 were imputed using the hot deck method||Percentage of Participants||95% Confidence Interval|Number
797749|NCT00935311|Secondary|Participants With Adverse Events (AEs)|An adverse event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with treatment. If an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE): results in death or is life-threatening, results in admission or prolongation of hospitalization, results in congenital anomaly or persistent or significant disability/incapacity, or is an important medical event requiring medical or surgical intervention to prevent serious outcome. AEs were categorized by severity (mild, moderate, severe) and relationship to treatment (probably, possibly, probably not, not related). Please see Adverse Events section below for more details.|AEs were recorded from study drug administration until 30 days following discontinuation of study drug (total 30 days); SAEs were recorded from the time informed consent was obtained until 30 days following discontinuation of study drug (total 51 days).|All randomized participants who received at least 1 dose of study drug.||participants|||Number
797750|NCT00935311|Secondary|Time to First Rescue Medication|The median time (minutes) from first dose of study drug to first use of analgesic rescue medication.|From time of first study drug administration to 12 hours following first study drug administration|All randomized participants who received at least 1 dose of study drug.||minutes||95% Confidence Interval|Median
797751|NCT00935311|Secondary|TOTPAR (Total Pain Relief)|TOTPAR was the time-interval weighted sum of pain relief. Pain relief was assessed by participants’ responses to how their pain relief was compared with the pain they had just before receiving the first dose of study drug: no relief, a little relief, some relief, a lot of relief, or complete relief. Higher mean TOTPAR scores indicate better pain relief. The TOTPAR score is a measure of the cumulative pain intensity difference during treatment and the area under the curve was estimated using the linear trapezoidal rule.|From time of first study drug administration to 12 hours following first study drug administration|All randomized participants who received at least 1 dose of study drug.||scores on a scale||Standard Error|Least Squares Mean
797752|NCT00935311|Primary|Sum of Pain Intensity Difference (SPID) Using the Pain Intensity Visual Analog Scale (VAS)|"Participants assessed pain intensity on a 100 mm visual analogue scale (VAS) with 0 meaning no pain and 100 meaning the worst pain imaginable. The SPID VAS score for 0 to 12 hours following initial study drug dose measured the cumulative pain intensity difference during treatment with higher mean SPID VAS scores indicating greater improvement from Baseline. The SPID score is a measure of the cumulative pain intensity difference during treatment and the area under the curve was estimated using the linear trapezoidal rule."|From time of first study drug administration to 12 hours following first study drug administration|All randomized participants who received at least 1 dose of study drug.||scores on a scale||Standard Error|Least Squares Mean
797915|NCT00944021|Secondary|Pharmacokinetics- Terminal Elimination Phase Half-life (t1/2) (Day 1).||0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, and 24 hours post-dose on Day 1 of treatment|All PA-824 patients who received at least one administration of the investigational drug, had at least one measured concentration after the start of treatment for at least one PK analysis and had no major events affecting the integrity of the PK data.||hours||Standard Deviation|Mean
797753|NCT00943384|Secondary|Percent Change in Short Form 12 (SF-12v2) Mental Component Summary (MCS)|The SF-12v2, comprising 12 questions related to health and wellbeing over the prior four weeks, was administered to subjects preoperatively and at all follow up visits. SF-12v2 represents overall subjective health status by measuring eight health-related parameters (each scored from 0 [poor health] to 100 [better health]): body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. First, the eight scales were standardized using means and standard deviations (SD) for the general US population. Second, MCS was scored by aggregating the eight scales using a standardized algorithm. Finally, MCS was standardized using a linear t-score transformation to have a mean of 50 and a SD of 10 in the general US population (expected range: 10-70). Percent change was calculated as [(Month 24 – Baseline)/Baseline]*100%.|Month 24|Per protocol||percent change||Standard Deviation|Mean
797754|NCT00943384|Secondary|Short Form 12 (SF-12v2) Mental Component Summary (MCS)|The SF-12v2, comprising 12 questions related to health and wellbeing over the prior four weeks, was administered to subjects preoperatively and at all follow up visits. SF-12v2 represents overall subjective health status by measuring eight health-related parameters (each scored from 0 [poor health] to 100 [better health]): body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. First, the eight scales were standardized using means and standard deviations (SD) for the general US population. Second, MCS was scored by aggregating the eight scales using a standardized algorithm. Finally, MCS was standardized using a linear t-score transformation to have a mean of 50 and a SD of 10 in the general US population (expected range: 10-70).|Month 24|Per protocol||units on a scale||Standard Deviation|Mean
797755|NCT00943384|Secondary|Percent Change in Short Form 12 (SF-12v2) Physical Component Summary (PCS)|The SF-12v2, comprising 12 questions related to health and wellbeing over the prior four weeks, was administered to subjects preoperatively and at all follow up visits. SF-12v2 represents overall subjective health status by measuring eight health-related parameters (each scored from 0 [poor health] to 100 [better health]): body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. First, the eight scales were standardized using means and standard deviations (SD) for the general US population. Second, PCS was scored by aggregating the eight scales using a standardized algorithm. Finally, PCS was standardized using a linear t-score transformation to have a mean of 50 and a SD of 10 in the general US population (expected range: 13-69). Percent change was calculated as [(Month 24 – Baseline)/Baseline]*100%.|Month 24|Per protocol||percent change||Standard Deviation|Mean
797756|NCT00943384|Secondary|Short Form 12 (SF-12v2) Physical Component Summary (PCS)|The SF-12v2, comprising 12 questions related to health and wellbeing over the prior four weeks, was administered to subjects preoperatively and at all follow up visits. SF-12v2 represents overall subjective health status by measuring eight health-related parameters (each scored from 0 [poor health] to 100 [better health]): body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. First, the eight scales were standardized using means and standard deviations (SD) for the general US population. Second, PCS was scored by aggregating the eight scales using a standardized algorithm. Finally, PCS was standardized using a linear t-score transformation to have a mean of 50 and a SD of 10 in the general US population (expected range: 13-69).|Month 24|Per protocol||units on a scale||Standard Deviation|Mean
797757|NCT00943384|Secondary|Percent Change in Leg Pain on Visual Analog Scale|The subjects completed questionnaires assessing the intensity of pain experienced in the leg at the preoperative visit and at all visits postoperatively. Pain intensity was rated on a scale where zero indicated no pain, and 100 represented the worst possible pain. A negative change (post surgery minus baseline) indicated an improvement. Percent change was calculated as: [(Month 24-Baseline)/Baseline]*100%.|Month 24|Per protocol||percent change||Standard Deviation|Mean
797758|NCT00943384|Secondary|Leg Pain on Visual Analog Scale|The subjects completed questionnaires assessing the intensity of pain experienced in the leg at the preoperative visit and at all visits postoperatively. Pain intensity was rated on a scale where zero indicated no pain, and 100 represented the worst possible pain.|Month 24|Per protocol.||units on a scale||Standard Deviation|Mean
797759|NCT00943384|Secondary|Percent Change in Back Pain on Visual Analog Scale|The subjects completed questionnaires assessing the intensity of pain experienced in the back at the preoperative visit and at all visits postoperatively. Pain intensity was rated on a scale where zero indicated no pain, and 100 represented the worst possible pain. A negative change (post surgery minus baseline) indicated an improvement. Percent change was calculated as: [(Month 24-Baseline)/Baseline]*100%.|Month 24|Back pain was assessed in the per-protocol population. Of the 55 subjects who were evaluated at the Month 24 visit, two were missing data related to back pain.||percent change||Standard Deviation|Mean
797760|NCT00943384|Secondary|Back Pain on Visual Analog Scale|The subjects completed questionnaires assessing the intensity of pain experienced in the back at the preoperative visit and at all visits postoperatively. Pain intensity was rated on a scale where zero indicated no pain, and 100 represented the worst possible pain.|Month 24|Of the 55 subjects who were evaluated at Month 24, two were missing back pain data.||units on a scale||Standard Deviation|Mean
797761|NCT00943384|Secondary|Percent Change in Oswestry Disability Index (ODI)|The Oswestry Low Back Pain Disability Questionnaire was self-administered to each subject preoperatively and at each clinical follow up examination. Each of the ten questions had six ordered responses coded on a scale from zero to five. The scale ranges from 0-100. A higher score indicates a higher level of disability, and a negative percent change (post surgery minus baseline) indicates improved function. Percent change in ODI score was calculated as: [(Month 24-Baseline)/Baseline]*100%.|Month 24|Per protocol||percent change||Standard Deviation|Mean
797762|NCT00943384|Secondary|Oswestry Disability Index (ODI)|The Oswestry Low Back Pain Disability Questionnaire was self-administered to each subject preoperatively and at each clinical follow up examination. Each of the ten questions had six ordered responses coded on a scale from zero to five. The scale ranges from 0-100. A higher score indicates a higher level of disability, and a negative percent change (post surgery minus baseline) indicates improved function.|Month 24|Per protocol||units on a scale||Standard Deviation|Mean
797763|NCT00943384|Primary|Posterolateral Fusion Success|The primary outcome for posterolateral fusion status was a composite endpoint incorporating posterior bridging bone status, intersegmental motion (angular and translational motion) and posterior hardware status. To have successful posterolateral fusion, a subject had to be successful in all four components at all levels under investigation. Failure to meet any one of the four components indicated failed posterolateral fusion status.|Month 24|The primary endpoint was evaluated for the per-protocol population. Of the 55 patients who were evaluated at the Month 24 visit, six patients were missing complete radiographic data needed to evaluate the primary endpoint.||participants|||Number
797764|NCT00943397|Primary|Number of Clinical Adverse Experiences (CAEs) Reported by Patients With up to 52 Weeks of Treatment|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|Up to 52 weeks of treatment|All patients who took study medication were included in the analysis.||Participants|||Number
797765|NCT00943436|Primary|Percent Energy From Fat at the Meal (Rest Session)|Fat intake was measured by weighing each item served in the ad libitum buffet meal before and after the subject's meal and subtracting the difference to determine gram weight of each item consumed. Food labels and the NDS-R software were used to determine dietary intake based upon gram weight of each food consumed.|2 hours|||percentage of kilocalorie intake||Standard Deviation|Mean
797766|NCT00943436|Primary|Percent Energy From Fat at the Meal (Exercise Session)|Fat intake was measured by weighing each item served in the ad libitum buffet meal before and after the subject's meal and subtracting the difference to determine gram weight of each item consumed. Food labels and the NDS-R software were used to determine dietary intake based upon gram weight of each food consumed.|2 hours|||percentage of kilocalorie intake||Standard Deviation|Mean
797767|NCT00943436|Primary|Percent Energy From Protein at the Meal (Rest Session)|Protein intake was measured by weighing each item served in the ad libitum buffet meal before and after the subject's meal and subtracting the difference to determine gram weight of each item consumed. Food labels and the NDS-R software were used to determine dietary intake based upon gram weight of each food consumed.|2 hours|||percentage of kilocalorie intake||Standard Deviation|Mean
797768|NCT00943436|Primary|Percent Energy From Protein at the Meal (Exercise Session)|Protein intake was measured by weighing each item served in the ad libitum buffet meal before and after the subject's meal and subtracting the difference to determine gram weight of each item consumed. Food labels and the NDS-R software were used to determine dietary intake based upon gram weight of each food consumed.|2 hours|||percentage of kilocalorie intake||Standard Deviation|Mean
797769|NCT00943436|Primary|Percent Energy From Carbohydrate at the Meal (Rest Session)|carbohydrate intake was measured by weighing each item served in the ad libitum buffet meal before and after the subject's meal and subtracting the difference to determine gram weight of each item consumed. Food labels and the NDS-R software were used to determine dietary intake based upon gram weight of each food consumed.|2 hours|||percentage of kilocalorie intake||Standard Deviation|Mean
797770|NCT00943436|Primary|Percent Energy From Carbohydrate at the Meal (Exercise Session)|Carbohydrate intake was measured by weighing each item served in the ad libitum buffet meal before and after the subject's meal and subtracting the difference to determine gram weight of each item consumed. Food labels and the NDS-R software were used to determine dietary intake based upon gram weight of each food consumed.|2 hours|||percentage of kilocalorie intake||Standard Deviation|Mean
797771|NCT00943436|Primary|Energy Intake at the Meal (Rest Session)|Energy intake was measured by weighing each item served in the ad libitum buffet meal before and after the subject's meal and subtracting the difference to determine gram weight of each item consumed. Food labels and the NDS-R software were used to determine dietary intake based upon gram weight of each food consumed.|2 hours|||kilocalories||Standard Deviation|Mean
797772|NCT00943436|Primary|Energy Intake at the Meal (Exercise Session)|Energy intake was measured by weighing each item served in the ad libitum buffet meal before and after the subject's meal and subtracting the difference to determine gram weight of each item consumed. Food labels and the NDS-R software were used to determine dietary intake based upon gram weight of each food consumed.|2 hours|||kilocalories||Standard Deviation|Mean
797773|NCT00943488|Secondary|Number of Participants in the 65 Years and Older Age Stratum With a Serum HAI Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 2 Doses of H1N1 Vaccine.|Blood was collected from all participants at Day 21 post second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the second vaccination|Participants were included in the analyses if they received the both vaccinations, with the second within 4 days of the window, and had blood collected at the timepoint. Analysis was as treated, restricted to age stratum. One participant was excluded due to presumed H1N1 infection, and four due to receiving non-study vaccines prior to the visit.||Participants|||Number
797774|NCT00943488|Secondary|Number of Participants in the 18-64 Year Age Stratum With a Serum HAI Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 2 Doses of H1N1 Vaccine.|Blood was collected from all participants at Day 21 post second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the second vaccination|Participants were included in the analyses if they received both vaccinations, with the second vaccination given within 4 days of the window, and had blood collected at both timepoints. Participants were analyzed as treated and restricted to age stratum. One participant was excluded due to receiving a non-study vaccine prior to the visit.||Participants|||Number
797879|NCT00943878|Primary|Number of Participants Reporting Solicited Quantitative Local Reactions After the First Placebo Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Within 8 days (Day 0-7) post first placebo vaccination|Participants who received the first placebo vaccination are included. Analyses are as treated.||Participants|||Number
797775|NCT00943488|Secondary|Number of Participants in the 65 Years and Older Age Stratum With a Serum HAI Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 8-10 Days Following 2 Doses of H1N1 Vaccine.|Blood was collected from all participants at Day 8-10 post second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 8-10 after the second vaccination|Participants were included in the analyses if they received the both vaccinations, with the second within 4 days of the window, and had blood collected at the timepoint. Analysis was as treated, restricted to age stratum. One participant was excluded due to presumed H1N1 infection, and three due to receiving non-study vaccines prior to the visit.||Participants|||Number
797776|NCT00943488|Secondary|Number of Participants in the 18-64 Year Age Stratum With a Serum HAI Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 8-10 Days Following 2 Doses of H1N1 Vaccine.|Blood was collected from all participants at Day 8-10 post second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 8-10 after the second vaccination|Participants were included in the analyses if they received both vaccinations, with the second vaccination given within 4 days of the window, and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum.||Participants|||Number
797777|NCT00943488|Secondary|Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 2 Doses of H1N1 Vaccine.|Blood was collected from all participants prior to the initial vaccination and 21 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post vaccination 2 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 post vaccination 2 titer was an increase by 4-fold or more.|Day 0 prior to first vaccination and Day 21 after the second vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at the timepoint. Participants were analyzed as treated and restricted to age stratum. One participant was excluded due to presumed natural Influenza H1N1 infection, and four due to receiving non-study vaccines prior to the visit.||Participants|||Number
797778|NCT00943488|Secondary|Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 2 Doses of H1N1 Vaccine.|Blood was collected from all participants prior to the initial vaccination and 21 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post vaccination 2 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 post vaccination 2 titer was an increase by 4-fold or more.|Day 0 prior to first vaccination and Day 21 after the second vaccination|Participants were included in the analyses if they received both vaccinations, with the second vaccination given within 4 days of the window, and had blood collected at both timepoints. Participants were analyzed as treated and restricted to age stratum. One participant was excluded due to receiving a non-study vaccine prior to the visit.||Participants|||Number
797779|NCT00943488|Primary|Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of Vaccine|Blood was collected from all participants prior to vaccination and at the 21 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to and Day 21 after first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints. Participants were analyzed as treated and restricted to age stratum. One participant was excluded due to presumed natural Influenza H1N1 infection, and two due to receiving non-study vaccines prior to the visit.||Participants|||Number
797780|NCT00943488|Primary|Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of Vaccine|Blood was collected from all participants prior to vaccination and at the 21 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to and Day 21 after first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum.||Participants|||Number
797781|NCT00943488|Primary|Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 1 Dose of Vaccine|Blood was collected from all participants prior to vaccination and at the 8-10 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more.|Day 0 prior to and Day 8-10 after first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum. One participant was excluded due to presumed natural Influenza H1N1 infection prior to the Day 8-10 visit.||Participants|||Number
798100|NCT00945893|Secondary|Number of Participants With Any Solicited Symptom Within 7 Days Post Vaccination, Dose 2||Days 29-36|The Safety Population for solicited symptoms dose 2 was defined as all participants who received Dose 2, had any follow-up for safety and had solicited symptom data available during the reporting period.||Participants|||Number
797782|NCT00943488|Primary|Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 1 Dose of Vaccine|Blood was collected from all participants prior to vaccination and at the 8-10 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more.|Day 0 prior to and Day 8-10 after first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum.||Participants|||Number
797783|NCT00943488|Primary|Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)|Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof; resulted in a congenital anomaly/birth defect; or may have jeopardized the participant or required intervention to prevent one of these outcomes. Association to vaccination was determined by a study clinician licensed to make medical diagnoses.|Day 0 through Day 180 after last vaccination|All participants receiving the first vaccination are included in the safety ITT cohort||Participants|||Number
797784|NCT00943488|Primary|Number of Participants in the 65 Years and Older Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of H1N1 Vaccine|Blood was collected from all participants at the 21 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at the timepoint. Participants were analyzed as treated and restricted to age stratum. One participant was excluded due to presumed natural Influenza H1N1 infection, and two were excluded due to receiving non-study vaccines prior to the visit.||Participants|||Number
797785|NCT00943488|Primary|Number of Participants in the 18-64 Year Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of H1N1 Vaccine|Blood was collected from all participants at the 21 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at the timepoint. Participants were analyzed as treated. This outcome measure restricts to age stratum.||Participants|||Number
797786|NCT00943488|Primary|Number of Participants in the 65 Years and Older Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus Prior to and 8-10 Days Following 1 Dose of H1N1 Vaccine|Blood was collected from all participants prior to vaccination and at the 8-10 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 0 prior to and Day 8-10 after first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum. One participant was excluded due to presumed natural Influenza H1N1 infection prior to the Day 8-10 visit.||Participants|||Number
797787|NCT00943488|Primary|Number of Participants in the 18-64 Year Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus Prior to and 8-10 Days Following 1 Dose of H1N1 Vaccine|Blood was collected from all participants prior to vaccination and at the 8-10 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 0 prior to and Day 8-10 after first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum.||Participants|||Number
797788|NCT00943488|Primary|Number of Participants Reporting Fever After the Second Vaccination|Participants were provided with a thermometer and a memory aid on which to record daily oral temperatures for 8 days after vaccination (Day 0-7). The protocol defined fever as oral temperature of 38.0 degrees Celsius or higher. Participants are counted as experiencing fever if they reported oral temperatures of 38.0 degrees Celsius or higher on any of the 8 days.|Day 0-7 after second vaccination|All participants receiving the second vaccination are included in the safety ITT cohort||Participants|||Number
797789|NCT00943488|Primary|Number of Participants Reporting Fever After the First Vaccination|Participants were provided with a thermometer and a memory aid on which to record daily oral temperatures for 8 days after vaccination (Day 0-7). The protocol defined fever as oral temperature of 38.0 degrees Celsius or higher. Participants are counted as experiencing fever if they reported oral temperatures of 38.0 degrees Celsius or higher on any of the 8 days.|Day 0-7 after first vaccination|All participants receiving the first vaccination are included in the safety ITT cohort||Participants|||Number
797790|NCT00943488|Primary|Number of Participants Reporting Solicited Systemic Symptoms Based on the Functional Grading Scale After the Second Vaccination|Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea for 8 days after vaccination (Day 0-7) based on their interference with daily activities, with a severity grade of mild meaning no interference, moderate as some interference and severe as significant interference/prevented daily activity. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Day 0-7 after second vaccination|All participants receiving the second vaccination are included in the safety ITT cohort||Participants|||Number
799516|NCT00948246|Secondary|Change in BMI|Decrease in body mass index (BMI; measured in kg/m2) from baseline to 12 months|12 months|||kg/m2||95% Confidence Interval|Mean
797791|NCT00943488|Primary|Number of Participants Reporting Solicited Systemic Symptoms Based on the Functional Grading Scale After the First Vaccination|Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea for 8 days after vaccination (Day 0-7) based on their interference with daily activities, with a severity grade of mild meaning no interference, moderate as some interference and severe as significant interference/prevented daily activity. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Day 0-7 after first vaccination|All participants receiving the first vaccination are included in the safety ITT cohort||Participants|||Number
797792|NCT00943488|Secondary|Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 2 Doses of H1N1 Vaccine.|Blood was collected from all participants prior to the initial vaccination and 8-10 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 post vaccination 2 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 post vaccination 2 titer was an increase by 4-fold or more.|Day 0 prior to first vaccination and Day 8-10 after the second vaccination|Participants were included in the analyses if they received the both vaccinations, with the second within 4 days of the window, and had blood collected at the timepoint. Analysis was as treated, restricted to age stratum. One participant was excluded due to presumed H1N1 infection, and three due to receiving non-study vaccines prior to the visit.||Participants|||Number
797793|NCT00943488|Secondary|Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 2 Doses of H1N1 Vaccine.|Blood was collected from all participants prior to the initial vaccination and 8-10 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 post vaccination 2 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 post vaccination 2 titer was an increase by 4-fold or more.|Day 0 prior to first vaccination and Day 8-10 after the second vaccination|Participants were included in the analyses if they received both vaccinations, with the second vaccination given within 4 days of the window, and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum.||Participants|||Number
797794|NCT00943488|Primary|Number of Participants Reporting Measured Injection Site Reactions of Swelling and Redness After the Second Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Day 0-7 after second vaccination|All participants receiving the second vaccination are included in the safety ITT cohort||Participants|||Number
797795|NCT00943488|Primary|Number of Participants Reporting Measured Injection Site Reactions of Swelling and Redness After the First Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Day 0-7 after first vaccination|All participants receiving the first vaccination are included in the safety ITT cohort||Participants|||Number
797796|NCT00943488|Primary|Number of Participants Reporting Solicited Local Reactions Based on the Functional Grading Scale After the Second Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities, with a severity grade of mild meaning no interference, moderate as some interference and severe as significant interference/prevented daily activity. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Day 0-7 after second vaccination|All participants receiving the second vaccination are included in the safety ITT cohort||Participants|||Number
797797|NCT00943488|Primary|Number of Participants Reporting Solicited Local Reactions Based on the Functional Grading Scale After the First Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities, with a severity grade of mild meaning no interference, moderate as some interference and severe as significant interference/prevented daily activity. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Day 0-7 after first vaccination|All participants receiving the first vaccination are included in the safety ITT cohort||Participants|||Number
797798|NCT00943579|Secondary|Adverse Events Reporting||Cummulative throughout study||||||
797799|NCT00943579|Secondary|Aberrant Behavior Checklist (ABC)|This is a 58-item informant-based, factor-analyzed scale comprised of a total scale and 5 subscales that generate raw scores. Scores based on a likert scale ranging from 0-3 where 0 is not a problem to 3 where the problem is severe. Subscales include: Irritability, Social Withdrawal, Stereotypic Behaviors, Hyperactivity and Inappropriate Speech. Total maximum score is 174. Higher subscale scores indicate more symptoms. Scores are totaled to compute subscale scores. Mixed-effects regression models via SPSS MIXED determined the main effects attributed to differences by group (BH4 and placebo), time (treated as categorical at levels baseline, 8 weeks, and 16 weeks) and the group-by-time interaction. The mixed-effects models accounted for each participant's outcome data at each time point. We used random intercept and trend modeling that accounts for each individual's initial level of symptom severity/functioning and rate of change/time|Weeks baseline (week 16 from CHC-0901), 8 and 16. Primary outcome assessment looked at change between baseline (week 16 from CHC-0901 and week 16 of CHC-0902).|all participants who completed the open label extension were analyzed.||units on a scale||Standard Error|Mean
797800|NCT00943579|Secondary|Connor’s Preschool ADHD Questionnaire||Weeks 8 & 16||||||
798101|NCT00945893|Secondary|Number of Participant Using Anti-pyretic and Analgesic Agents Within 14 Days Post Vaccination, Dose 1||Days 1-15|The Safety Population was defined as all participants who received at least one dose of investigational product and had any follow-up for safety.||Participants|||Number
797801|NCT00943579|Secondary|Preschool Language Scale, 4th Edition (PLS-4)|Measures expressive & receptive language and total scores in ages 0 to 6 years 11 months. The scales generate raw, standard, and age-equivalent scores; raw scores for the total scale were selected for use in this study. Total is average of subscales. Minimum raw score = 0, maximum = 130. Higher raw scores indicate better language skills. Mixed-effects regression models via SPSS MIXED determined the main effects attributed to differences by group (BH4 and placebo), time (treated as categorical at levels baseline, 8 weeks, and 16 weeks) and the group-by-time interaction. The mixed-effects models accounted for each participant's outcome data at each time point. We used random intercept & trend modeling that accounts for each individual's initial level of symptom severity/functioning & rate of change/time|Weeks baseline (week 16 from CHC-0901), 8 and 16. Primary outcome assessment looked at change between baseline (week 16 from CHC-0901 and week 16 of CHC-0902).|All participants completed the open label extension were analyzed in the study.||units on a scale||Standard Error|Mean
797802|NCT00943579|Secondary|Parental Global Assessment||Weeks 8 & 16||||||
797803|NCT00943579|Secondary|Children’s Yale Brown Obsessive Compulsive Scale||Weeks 8 & 16||||||
797804|NCT00943579|Secondary|Vineland Adaptive Behavior Scale, 2nd Edition|The Vineland-2 is semi-structured interview designed to communication, daily living, socialization and motor skills. The Vineland-2 is comprised of a total Adaptive Composite Scale; we chose to use 10 subscales that specifically address functional domains relevant for a young ASD sample - Receptive Communication, Expressive Communication, Personal Daily Living Skills, Domestic Daily Living Skills, Community Daily Living Skills, Interpersonal Relations, Play Skills, Coping Skills, Gross Motor Skills, Fine Motor Skills. The scales generate raw or sum, V-, and age-equivalent scores; raw scores were selected for use in this study. Higher subscale scores indicate more skills. Raw scores can range from 0 to 766 for the overall adaptive behavior composite. Subscales are combined to form the overall Adaptive Behavior Composite, which is essentially a weighted average of the various subscales combined.|Weeks baseline (week 16 from CHC-0901), 8 and 16. Primary outcome assessment looked at change between baseline (week 16 from CHC-0901 and week 16 of CHC-0902).|All participants who completed the open label extension were analyzed.||units on a scale||Standard Error|Mean
797805|NCT00943579|Primary|Clinical Global Impressions Scale|This is a summary judgment made by a trained clinician based on observed and reported behaviors of the child compared to baseline. It is a 7-point scale (1) very much improved, (2) much improved, (3) minimally improved (4) no change, (5) minimally worse, (6) much worse and (7) very much worse. Chi-square analyses were used to assess change in CHI-I scores (by group, post-test)Mixed-effects regression models determined the main effects attributed to differences by group (BH4 and placebo), time (treated as categorical at levels baseline, 8 weeks, and 16 weeks) and the group-by-time interaction. The mixed-effects models accounted for each participant's outcome data at each time point. The mixed-effects regression model is robust to data dependency that occurs with the repeated assessments of individuals over time & can handle missing data. We used random intercept and trend modeling that accounts for each individual's initial level of symptom severity/functioning and rate of change/time|16 weeks|The number of participants analyzed included those who completed the open label extension of this study.||# participants much - very much improved|||Number
797806|NCT00943592|Secondary|Relapse Rate||1 year|74 patients received the Maximum Tolerated Dose of clofarabine 40 mg/m2 IV daily x 5 days, melphalan 140 mg/m2 x 1 day, and alemtuzumab 20 mg IV daily x 5 days||percentage of participants||95% Confidence Interval|Number
797807|NCT00943592|Secondary|Treatment-related Mortality (TRM)||1 year|74 patients received the Maximum Tolerated Dose of clofarabine 40 mg/m2 IV daily x 5 days, melphalan 140 mg/m2 x 1 day, and alemtuzumab 20 mg IV daily x 5 days||percentage of participants||95% Confidence Interval|Number
797808|NCT00943592|Secondary|Progression-free Survival (PFS)|Progression is defined from stem cell infusion to disease relapse, i.e., recurrence of hematologic malignancy and/or need for treatment after transplant for disease or death from any cause, whichever occurred first.|1 year|74 patients received the Maximum Tolerated Dose of clofarabine 40 mg/m2 IV daily x 5 days, melphalan 140 mg/m2 x 1 day, and alemtuzumab 20 mg IV daily x 5 days||percentage of participants||95% Confidence Interval|Number
797809|NCT00943592|Primary|Number of Participants With Other Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation|Toxicity was scored according to NCI/CTC version 3|Day 7 until Day 30|||participants|||Number
797810|NCT00943592|Primary|Number of Participants With Skin Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation|Toxicity was scored according to NCI/CTC version 3|Day 7 until Day 30|||participants|||Number
797811|NCT00943592|Primary|Number of Participants With Renal Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation|Toxicity was scored according to NCI/CTC version 3|Day 7 until Day 30|||participants|||Number
797812|NCT00943592|Secondary|Overall Survival (OS)||1 year|74 patients received the Maximum Tolerated Dose of clofarabine 40 mg/m2 IV daily x 5 days, melphalan 140 mg/m2 x 1 day, and alemtuzumab 20 mg IV daily x 5 days||percentage of participants||95% Confidence Interval|Number
797813|NCT00943592|Primary|Number of Participants With Hepatic Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation|Toxicity was scored according to NCI/CTC version 3|Day 7 until Day 30|||participants|||Number
797814|NCT00943605|Secondary|Pain Score by Visual Analog Scale, Narcotic Consumption, Operative Time, Time to Surgical Drain Removal||0 to 10 days postoperatively|An integrity audit found that the data for this study could not be analyzed owing to unverifiable source documentation.|||||
797815|NCT00943605|Primary|Area of Skin Necrosis Measured With a Standard Ruler||1 and 6 weeks postoperative|An integrity audit found that the data for this study could not be analyzed owing to unverifiable source documentation.|||||
797816|NCT00943605|Primary|Total Serous Drainage (mL) From Time of Drain Placement to Removal.||0 to 10 days postoperatively|An integrity audit found that the data for this study could not be analyzed owing to unverifiable source documentation.|||||
797880|NCT00943878|Primary|Number of Participants Reporting Solicited Quantitative Local Reactions After the TIV Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Within 8 days (Day 0-7) post TIV vaccination|Participants who received the TIV vaccination are included. Analyses are as treated.||Participants|||Number
797817|NCT00943631|Secondary|Number of Participants in the 65 Years and Older Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 2 Doses of H1N1 Vaccine|Blood was collected from all participants at Day 21 post second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the second vaccination|Participants were included in the analyses if they received both vaccinations and had blood collected at the timepoint. Participants were analyzed as treated. This outcome measure restricts to age stratum. One subject was excluded due to receipt of an non-study vaccine prior to the clinic visit.||Participants|||Number
797818|NCT00943631|Secondary|Number of Participants in the 65 Years and Older Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 8-10 Days Following 2 Doses of H1N1 Vaccine|Blood was collected from all participants at Day 8-10 post second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 8-10 after the second vaccination|Participants were included in the analyses if they received both vaccinations and had blood collected at the timepoint. Participants were analyzed as treated. This outcome measure restricts to age stratum. One subject was excluded due to receipt of an non-study vaccine prior to the clinic visit.||Participants|||Number
797819|NCT00943631|Primary|Number of Participants in the 65 Years and Older Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of H1N1 Vaccine|Blood was collected from all participants at the 21 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at the timepoint. Participants were analyzed as treated. This outcome measure restricts to age stratum. One participant was excluded due to the blood being collected after administration of the second vaccination.||Participants|||Number
797820|NCT00943631|Primary|Number of Participants in the 18-64 Year Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of H1N1 Vaccine|Blood was collected from all participants at the 21 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at the timepoint. Participants were analyzed as treated. This outcome measure restricts to age stratum.||Participants|||Number
797821|NCT00943631|Primary|Number of Participants in the 65 Years and Older Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus Prior to and at 8-10 Days Following 1 Dose of H1N1 Vaccine|Blood was collected from all participants prior to vaccination and at the 8-10 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 0 prior to and Day 8-10 after first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum.||Participants|||Number
797822|NCT00943631|Secondary|Number of Participants in the 18-64 Year Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 8-10 and 21 Days Following 2 Doses of H1N1 Vaccine|Blood was collected from all participants at Day 8-10 and Day 21 post second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 8-10 and Day 21 after the second vaccination|Participants were included in the analyses if they received both vaccinations and had blood collected at the timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum.||Participants|||Number
797823|NCT00943631|Secondary|Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 2 Doses of H1N1 Vaccine|Blood was collected from all participants prior to the initial vaccination and 21 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post vaccination 2 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 post vaccination 2 titer was an increase by 4-fold or more.|Baseline and Day 21 after the second vaccination|Participants were included in the analyses if they received the both vaccinations and had blood collected at the timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum. One subject was excluded due to receipt of a non-study vaccine prior to the clinic visit.||Participants|||Number
797824|NCT00943631|Primary|Number of Participants in the 18-64 Year Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus Prior to and at 8-10 Days Following 1 Dose of H1N1 Vaccine|Blood was collected from all participants prior to vaccination and at the 8-10 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 0 prior to and Day 8-10 after first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum.||Participants|||Number
797825|NCT00943631|Primary|Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of Vaccine|Blood was collected from all participants prior to vaccination and at the 21 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more.|Baseline and Day 21 after first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum. One participant was excluded due to the blood being collected after administration of the second vaccination.||Participants|||Number
797826|NCT00943631|Primary|Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of Vaccine|Blood was collected from all participants prior to vaccination and at the 21 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more.|Baseline and Day 21 after first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum.||Participants|||Number
797827|NCT00943631|Primary|Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 1 Dose of Vaccine|Blood was collected from all participants prior to vaccination and at the 8-10 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more.|Baseline and Day 8-10 after first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum.||Participants|||Number
797828|NCT00943631|Primary|Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 1 Dose of Vaccine|Blood was collected from all participants prior to vaccination and at the 8-10 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more.|Baseline and Day 8-10 after first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum.||Participants|||Number
797829|NCT00943631|Primary|Number of Participants Reporting Fever After the Second Vaccination|Participants were provided with a thermometer and a memory aid on which to record daily oral temperatures for 8 days after vaccination (Day 0-7). The protocol defined fever as oral temperature of 38.0 degrees Celsius or higher. Participants are counted as experiencing fever if they reported oral temperatures of 38.0 degrees Celsius or higher on any of the 8 days.|Day 0-7 after second vaccination|All participants receiving the second vaccination are included in the safety ITT cohort.||Participants|||Number
797830|NCT00943631|Primary|Number of Participants Reporting Fever After the First Vaccination|Participants were provided with a thermometer and a memory aid on which to record daily oral temperatures for 8 days after vaccination (Day 0-7). The protocol defined fever as oral temperature of 38.0 degrees Celsius or higher. Participants are counted as experiencing fever if they reported oral temperatures of 38.0 degrees Celsius or higher on any of the 8 days.|Day 0-7 after first vaccination|All participants receiving the first vaccination are included in the safety ITT cohort.||Participants|||Number
797831|NCT00943631|Primary|Number of Participants Reporting Solicited Systemic Reactions Based on the Functional Grading Scale After the Second Vaccination|Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Day 0-7 after second vaccination|All participants receiving the second vaccination are included in the safety ITT cohort.||Participants|||Number
797832|NCT00943631|Primary|Number of Participants Reporting Solicited Systemic Reactions Based on the Functional Grading Scale After the First Vaccination|Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Day 0-7 after first vaccination|All participants receiving the first vaccination are included in the safety ITT cohort.||Participants|||Number
797833|NCT00943631|Primary|Number of Participants Reporting Measured Injection Site Reactions of Swelling and Redness After the Second Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Day 0-7 after second vaccination|All participants receiving the second vaccination are included in the safety ITT cohort.||Participants|||Number
797881|NCT00943878|Primary|Number of Participants Reporting Solicited Quantitative Local Reactions After the Second H1N1 Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Within 8 days (Day 0-7) post second H1N1 vaccination|Participants who received the second H1N1 vaccination are included. Analyses are as treated.||Participants|||Number
797834|NCT00943631|Secondary|Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 2 Doses of H1N1 Vaccine|Blood was collected from all participants prior to the initial vaccination and 8-10 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post vaccination 2 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 post vaccination 2 titer was an increase by 4-fold or more.|Baseline and Day 8-10 after the second vaccination|Participants were included in the analyses if they received the both vaccinations and had blood collected at the timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum. One subject was excluded due to receipt of a non-study vaccine prior to the clinic visit.||Participants|||Number
797835|NCT00943631|Secondary|Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 and 21 Days Following 2 Doses of H1N1 Vaccine|Blood was collected from all participants prior to the initial vaccination as well as 8-10 and 21 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post vaccination 2 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 post vaccination 2 titer was an increase by 4-fold or more.|Baseline and Day 8-10 and 21 after the second vaccination|Participants were included in the analyses if they received the both vaccinations and had blood collected at the timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum.||Participants|||Number
797836|NCT00943631|Primary|Number of Participants Reporting Measured Injection Site Reactions of Swelling and Redness After the First Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Day 0-7 after first vaccination|All participants receiving the first vaccination are included in the safety ITT cohort.||Participants|||Number
797837|NCT00943631|Primary|Number of Participants Reporting Solicited Local Reactions Based on the Functional Grading Scale After the Second Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Day 0-7 after second vaccination|All participants receiving the second vaccination are included in the safety ITT cohort.||Participants|||Number
797838|NCT00943631|Primary|Number of Participants Reporting Solicited Local Reactions Based on the Functional Grading Scale After the First Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Day 0-7 after first vaccination|All participants receiving the first vaccination are included in the safety ITT cohort.||Participants|||Number
797839|NCT00943631|Primary|Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)|Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof; resulted in a congenital anomaly/birth defect; or may have jeopardized the participant or required intervention to prevent one of these outcomes. Association to vaccination was determined by a study clinician licensed to make medical diagnoses.|Day 0 through Day 180 after last vaccination|||Participants|||Number
797840|NCT00943670|Secondary|Number of Participants With Anti-therapeutic Antibodies (ATAs) to Trastuzumab Emtansine|The number of participants with anti-T-DM1 antibodies was assessed using a validated bridging antibody enzyme-linked immunosorbent assay (ELISA).|Blood samples were collected prior to T-DM1 dosing, 15 and 60 minutes after the end of infusion, and anytime on Days 8 and 15 in Cycles 1 and 3, and pre-dose in Cycle 4.|Evaluable patients, defined as patients who had at least one ATA measurement available for analysis at Baseline (pre-dose in Cycle 1) and post-baseline.||participants|||Number
797841|NCT00943670|Secondary|Volume of Distribution at Steady State for T-DM1 and Total Trastuzumab||Blood samples were collected prior to T-DM1 dosing, 15 and 60 minutes after the end of infusion, and anytime on Days 8 and 15 in Cycles 1 and 3, and pre-dose in Cycle 4.|"PK-evaluable patients were defined as patients who had adequate concentration−time data to estimate at least one PK parameter. N refers to the number of PK-evaluable patients in that cycle."||mL/kg||Standard Deviation|Mean
797842|NCT00943670|Secondary|Clearance T-DM1 and Total Trastuzumab||Blood samples were collected prior to T-DM1 dosing, 15 and 60 minutes after the end of infusion, and anytime on Days 8 and 15 in Cycles 1 and 3, and pre-dose in Cycle 4.|"PK-evaluable patients were defined as patients who had adequate concentration−time data to estimate at least one PK parameter. N refers to the number of PK-evaluable patients in that cycle."||mL/day/kg||Standard Deviation|Mean
797843|NCT00943670|Secondary|Terminal Half-life for T-DM1 and Total Trastuzumab||Blood samples were collected prior to T-DM1 dosing, 15 and 60 minutes after the end of infusion, and anytime on Days 8 and 15 in Cycles 1 and 3, and pre-dose in Cycle 4.|"PK-evaluable patients were defined as patients who had adequate concentration−time data to estimate at least one PK parameter. N refers to the number of PK-evaluable patients in that cycle."||days||Standard Deviation|Mean
797844|NCT00943670|Secondary|Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity for T-DM1 and Total Trastuzumab|Area under the serum concentration−time curve from Time zero extrapolated to infinity (AUCinf) for T-DM1 (conjugated trastuzumab) and total trastuzumab (conjugated and unconjugated T-DM1) at Cycle 1.|Blood samples were collected prior to T-DM1 dosing, 15 and 60 minutes after the end of infusion, and anytime on Days 8 and 15 in Cycle 1.|"PK-evaluable patients were defined as patients who had adequate concentration−time data to estimate at least one PK parameter. N refers to the number of PK-evaluable patients in that cycle."||μg * day/mL||Standard Deviation|Mean
798994|NCT00950963|Secondary|Number of Patients With BP Less Than 130/80 mm Hg|Number of patients meeting blood pressure goals as defined by the American Diabetes Association guidelines.|18 months|Analysis per intention to treat||participants|||Number
797845|NCT00943670|Secondary|Area Under the Concentration-time Curve From Time 0 to Time of Last Measurable Concentration for T-DM1 and Total Trastuzumab|Area under the serum concentration−time curve from Time zero to time of last measurable concentration (AUClast) for T-DM1 (conjugated trastuzumab) and Total Trastuzumab (conjugated and unconjugated T-DM1) at Cycle 1 and Cycle 3.|Blood samples were collected prior to T-DM1 dosing, 15 and 60 minutes after the end of infusion, and anytime on Days 8 and 15 in Cycles 1 and 3, and pre-dose in Cycle 4.|"PK-evaluable patients were defined as patients who had adequate concentration−time data to estimate at least one PK parameter. N refers to the number of PK-evaluable patients in that cycle."||μg * day/mL||Standard Deviation|Mean
797846|NCT00943670|Secondary|Maximum Observed Serum Concentration of T-DM1 and Total Trastuzumab|Serum samples were quantitated for T-DM1 (DM1 conjugated to trastuzumab) levels in a validated assay using an indirect sandwich enzyme-linked immunosorbent assay (ELISA). The minimum quantifiable concentration in human serum was 40 ng/mL. Serum samples were assayed for total trastuzumab (conjugated and unconjugated T-DM1) in a validated assay using an indirect sandwich ELISA method; the minimum quantifiable concentration in human serum was 40 ng/mL.|Blood samples were collected prior to dosing, 15 and 60 minutes after the end of infusion, and anytime on Days 8 and 15 in Cycles 1 and 3, and pre-dose in Cycle 4.|"Pharmacokinetic (PK)-evaluable patients were defined as patients who had adequate concentration−time data to estimate at least one PK parameter. N refers to the number of PK-evaluable patients in that cycle."||μg/mL||Standard Deviation|Mean
797847|NCT00943670|Secondary|Number of Participants With Decreased Ejection Fraction|"Left ventricular ejection fraction (LVEF) was assessed on the basis of local assessments of echocardiogram or multigated acquisition scan (MUGA) data. A decrease in LVEF is defined as a decrease from Baseline of greater than or equal to 15%.
Grade 3 LVEF is an ejection fraction between 20 and 40%."|Assessed at Baseline and after every 3 cycles, up to 1 year.|Safety-Evaluable Patients (i.e., the treated population).||participants|||Number
797848|NCT00943670|Secondary|Number of Participants With Adverse Events (AEs)|"An serious AE is any AE that is fatal, life threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the investigational product(s), or is considered a significant medical event by the investigator (e.g., may jeopardize the patient or may require medical/surgical intervention to prevent one of the outcomes listed above).
The severity of each AE was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0, or as follows: Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Very severe; Grade 5 = Death related to AE."|From first dose until 30 days after last dose (up to 1 year).|Safety-Evaluable Patients (i.e., the treated population).||participants|||Number
797849|NCT00943670|Secondary|Percentage of Participants With Clinical Benefit During the Single-agent Trastuzumab Emtansine Treatment Period|"Participants were considered to have experienced clinical benefit if they had an objective response or maintained stable disease for at least 6 months from start of study treatment. Objective response was defined as a complete or partial response determined on two consecutive tumor assessments at least 4 weeks apart based on a modified version of RECIST.
Stable disease was defined as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started and no new lesions or unequivocal progression of existing nontarget lesions."|Tumor assessments were performed after every three cycles until study termination or progressive disease (up to a maximum of one year).|The efficacy-evaluable population was defined as patients who received at least one dose of study drug.||percentage of participants||95% Confidence Interval|Number
797850|NCT00943670|Secondary|Progression-free Survival During the Single-agent Trastuzumab Emtansine Treatment Period|Progression-free survival (PFS) was defined as the time from the first day of study treatment (Day 1) to first documented disease progression or death, whichever occurred first. If a patient did not experience disease progression or die, PFS was censored at the day of the last tumor assessment that a patient was known to be progression free.|From the first day of study treatment to the first documented disease progression or death, up to a maximum time period of one year.|Efficacy evaluable patients.||months||95% Confidence Interval|Median
797851|NCT00943670|Secondary|Duration of Objective Response Based on Investigator Assessment During the Single-agent Trastuzumab Emtansine Treatment Period|"In patients with an objective response during the single-agent trastuzumab emtansine treatment period, duration of response was defined as the time from the first documented objective response to the time of first documented disease progression or death, whichever occurred first. Progressive disease was defined as either at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study with an absolute increase of at least 5 mm, or the appearance of one or more new lesions, or the unequivocal progression of existing nontarget lesions.
If a patient did not die or experience disease progression before the end of the study, duration of response was censored at the day of the last tumor assessment when the patient was known to be progression free."|Time from the first documented objective response to the time of first documented disease progression or death, up to a maximum time period of one year.|Efficacy evaluable patients who achieved an objective response.||months||95% Confidence Interval|Median
797852|NCT00943670|Secondary|Percentage of Participants With an Objective Response During the Single-agent Trastuzumab Emtansine Treatment Period|"Objective response was defined as a complete response (CR) or partial response (PR) determined on two consecutive assessments conducted by the investigator ≥ 4 weeks apart. Responses were assessed by physical examination and imaged-based evaluation using a modified version of the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0:
CR—the disappearance of all target lesions and the disappearance of all nontarget lesions and normalization of tumor marker level and no new lesions.
PR—either the disappearance of all target lesions with persistence of one or more nontarget lesion(s) and/or the maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter with no new lesions or unequivocal progression of existing nontarget lesions."|Tumor assessments were performed after every three cycles until study termination or progressive disease (up to a maximum of one year).|The efficacy-evaluable population was defined as patients who received at least one dose of study drug. Patients with missing or no post-baseline response assessments were classified as non-responders.||percentage of participants||95% Confidence Interval|Number
811702|NCT01059760|Primary|Change From Baseline in Participant Sodium When Fasting and Fed||Baseline and 3 days|||mmol/L||Standard Deviation|Mean
797853|NCT00943670|Secondary|Percentage of Participants With New Abnormal T Waves|The incidence of abnormal T-wave changes from baseline was determined based on centrally read electrocardiogram (ECG) tracings comparing each of the three triplicate readings from the post baseline ECG time points to the baseline ECG reading. At each time point, if at least one of the three triplicate readings was abnormal, the participant was counted as abnormal for that ECG timepoint as follows: an inverted T, flat T, or biphasic T compared with baseline was considered an abnormal significant change from baseline. Additionally, nonspecific T-wave changes from baseline were considered as abnormal nonsignificant changes from baseline. T-wave changes from baseline due to ventricular conduction or left ventricular hypertrophy strain were considered not evaluable. C=Cycle; D=Day.|Cycle 1 Day 1, pre-dose (Baseline); Cycle 1 Day 1, 15 and 60 minutes post-dose; Cycle 1 Day 8; and Cycle 3 Day 1, 15 minutes pre-dose and 15 and 60 minutes post-dose.|ECG−Evaluable population; N indicates the ECG−evaluable population with available data at each time point.||percentage of participants|||Number
797854|NCT00943670|Secondary|Percentage of Participants With New Abnormal U Waves|The incidence of abnormal U-wave changes from baseline was determined based on centrally read electrocardiogram (ECG) tracings comparing each of the three triplicate readings from the post baseline ECG time points to the baseline ECG reading. At each time point, if at least one of the three triplicate readings was abnormal, the participant was counted as abnormal for that ECG timepoint as follows: a large U wave, inverted U wave, or T-U fusion compared with baseline was considered an abnormal significant change from baseline.|Cycle 1 Day 1, pre-dose (Baseline); Cycle 1 Day 1, 15 and 60 minutes post-dose; Cycle 1 Day 8; and Cycle 3 Day 1, 15 minutes pre-dose and 15 and 60 minutes post-dose.|ECG−evaluable population; N indicates the ECG−evaluable population with available data at each time point.||percentage of participants|||Number
797855|NCT00943670|Secondary|Percentage of Participants Within Each Baseline-adjusted QTc Interval Category|"The corrected QT interval was calculated using Fridericia's correction (QTcF) and using Bazett's correction (QTcB) from electrocardiogram (ECG) data. Each participant had triplicate QTc intervals measured at each timepoint and the average was calculated for each patient at each timepoint. For each timepoint, a participant's corresponding baseline QTc interval was subtracted from the average QTc intervals to create a baseline-adjusted average QTc interval.
QTc interval categories are based off International Conference on Harmonisation (ICH) Tripartite Guideline E14."|Cycle 1 Day 1, pre-dose (Baseline); Cycle 1 Day 1, 15 and 60 minutes post-dose; Cycle 1 Day 8; and Cycle 3 Day 1, 15 minutes pre-dose and 15 and 60 minutes post-dose.|The number of participants analyzed for each QTc interval category represents the total treated population. N indicates the ECG−evaluable population with available data at each time point.||percentage of participants|||Number
797856|NCT00943670|Secondary|Percentage of Participants Within Each Absolute QTc Interval Category|The corrected QT interval was calculated using Fridericia's correction (QTcF) and using Bazett's correction (QTcB) from electrocardiogram (ECG) data. Each participant had triplicate QTc intervals measured at each timepoint and the average was calculated for each patient at each timepoint. QTc interval categories are based off International Conference on Harmonisation (ICH) Tripartite Guideline E14.|Cycle 1 Day 1, 15 and 60 minutes post-dose; Cycle 1 Day 8; and Cycle 3 Day 1, 15 minutes pre-dose and 15 and 60 minutes post-dose.|The number of participants analyzed for each QTc interval category represents the total treated population. N indicates the ECG−evaluable population with available data at each time point.||percentage of participants|||Number
797857|NCT00943670|Secondary|Change From Baseline in Heart Rate||Cycle 1 Day 1, pre-dose (Baseline); Cycle 1 Day 1, 15 and 60 minutes post-dose; Cycle 1 Day 8; and Cycle 3 Day 1, 15 minutes pre-dose and 15 and 60 minutes post-dose.|ECG−evaluable population; N indicates the ECG−evaluable population with available data at each time point.||beats per minute||Standard Deviation|Mean
797858|NCT00943670|Secondary|Change From Baseline in QRS Duration|The QRS interval represents the time it takes for depolarization of the ventricles and was calculated from electrocardiogram (ECG) data. Each participant had triplicate QRS intervals measured at each timepoint and the average was calculated for each patient at each timepoint. For each timepoint, a participant's corresponding baseline QRS interval was subtracted from the average QRS intervals to create a baseline-adjusted average QRS interval.|Cycle 1 Day 1, pre-dose (Baseline); Cycle 1 Day 1, 15 and 60 minutes post-dose; Cycle 1 Day 8; and Cycle 3 Day 1, 15 minutes pre-dose and 15 and 60 minutes post-dose.|ECG−Evaluable population; N indicates the ECG−evaluable population with available data at each time point.||milliseconds||Standard Deviation|Mean
797859|NCT00943670|Secondary|Change From Baseline in PR Interval|The PR interval is the time in seconds from the beginning of the P wave to the beginning of the QRS complex, and was calculated from electrocardiogram (ECG) data. Each participant had triplicate PR intervals measured at each timepoint and the average was calculated for each patient at each timepoint. For each timepoint, a participant's corresponding baseline PR interval was subtracted from the average PR intervals to create a baseline-adjusted average PR interval.|Cycle 1 Day 1, pre-dose (Baseline); Cycle 1 Day 1, 15 and 60 minutes post-dose; Cycle 1 Day 8; and Cycle 3 Day 1, 15 minutes pre-dose and 15 and 60 minutes post-dose.|ECG-Evaluable population||milliseconds||Standard Deviation|Mean
797860|NCT00943670|Secondary|Change From Baseline in Uncorrected QT Interval|The uncorrected QT interval was calculated from electrocardiogram (ECG) data. Each participant had triplicate QT intervals measured at each timepoint and the average was calculated for each patient at each timepoint. For each timepoint, a participant's corresponding baseline QT interval was subtracted from the average QT intervals to create a baseline-adjusted average QT interval.|Cycle 1 Day 1, pre-dose (Baseline); Cycle 1 Day 1, 15 and 60 minutes post-dose; Cycle 1 Day 8; and Cycle 3 Day 1, 15 minutes pre-dose and 15 and 60 minutes post-dose.|ECG−Evaluable population; N indicates the ECG−evaluable population with available data at each time point.||milliseconds||Standard Deviation|Mean
797861|NCT00943670|Secondary|Change From Baseline in Mean Duration of the QTc Interval Using Bazett’s Correction|The corrected QT interval was calculated using Bazett’s correction (QTcB) from electrocardiogram (ECG) data. Each participant had triplicate QTcB intervals measured at each timepoint and the average was calculated for each patient at each timepoint. For each timepoint, a participant's corresponding baseline QTcB interval was subtracted from the average QTcB intervals to create a baseline-adjusted average QTcB interval.|Cycle 1 Day 1, pre-dose (Baseline); Cycle 1 Day 1, 15 and 60 minutes post-dose; Cycle 1 Day 8; and Cycle 3 Day 1, 15 minutes pre-dose and 15 and 60 minutes post-dose.|ECG−Evaluable population; N indicates the ECG−evaluable population with available data at each time point.||milliseconds||Standard Deviation|Mean
797862|NCT00943670|Primary|Change From Baseline in Mean Duration of the QTc Interval|The QT interval is a measure of time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. The corrected QT interval was calculated using Fridericia’s correction (QTcF) from electrocardiogram (ECG) data. Each participant had triplicate QTcF intervals measured at each timepoint and the average was calculated for each patient at each timepoint. For each timepoint, a participant’s corresponding baseline QTcF interval was subtracted from the average QTcF intervals to create a baseline-adjusted average QTcF interval.|Cycle 1 Day 1, pre-dose (Baseline); Cycle 1 Day 1, 15 and 60 minutes post-dose; Cycle 1 Day 8; and Cycle 3 Day 1, 15 minutes pre-dose and 15 and 60 minutes post-dose.|ECG−evaluable population consisted of patients who received T-DM1, had at least 1 interpretable pre−T-DM1 ECG measurement recorded on Cycle 1 Day 1, had at least 1 interpretable post−T-DM1 ECG measurement and who were not treated with medications that may have altered cardiac conduction. N indicates the ECG−evaluable population at each time point.||milliseconds||Standard Deviation|Mean
797863|NCT00943761|Primary|Percentage of Participants Who Achieved Sustained Viral Response 24 Weeks After the End of Treatment (SVR24)|SVR24 is defined as undetectable hepatitis C virus ribonucleic acid (HCV RNA) 24 weeks after the end of vaniprevir study therapy. HCV RNA plasma levels were assessed using the Roche COBAS Taqman assay (or equivalent) with the limit of quantification (LoQ) of at least 25 IU/mL and the limit of detection (LoD) of at least 10 IU/mL.|72 weeks|Population includes only a subset of participants previously treated with placebo + peg-IFN + RBV in a vaniprevir study and excludes participants for failure to receive >=1 dose of study drug, lack of any post-allocation endpoint data subsequent to >=1 dose of study drug, lack of baseline data, or missing data due to discontinuation from the study||Percentage of participants||95% Confidence Interval|Number
797864|NCT00943761|Primary|Number of Participants Who Discontinued Study Treatment Due to an Adverse Event|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.|48 weeks|All participants as treated population consists of all participants who received at least one dose of study treatment.||Participants|||Number
797865|NCT00943761|Primary|Number of Participants Who Experienced a Serious Adverse Event|Serious adverse event is defined as any adverse drug or biologic or device experience occurring at any dose resulting in death, was life-threatening, was persistent or caused significant disability/incapacity, required in-patient hospitalization or prolonged hospitalization, was a congenital anomaly or birth defect, was a cancer, or was an overdose.|up to 72 weeks|All participants as treated population consists of all participants who received at least one dose of study treatment.||Participants|||Number
797866|NCT00943761|Primary|Number of Participants Who Experienced an Adverse Event|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.|up to 72 weeks|All participants as treated population consists of all participants who received at least one dose of study treatment.||Participants|||Number
797867|NCT00943787|Secondary|Maximum Epinephrine Response (ADRR Groups)|"Mean maximum epinephrine response during induced hypoglycemia is the average of subjects' maximum concentration of all epinephrine measurements taken at plasma glucose level lower than 70mg/dL.
Average Daily Risk Range (ADRR) is associated with glycemic variability and risk of both hyper- and hypoglycemia.
Low Risk, ADRR < 20; Moderate Risk, 20 < ADRR < 40; and High Risk,ADRR > 40."|285 min (time of clamp)|3 participants did not have enough epinephrine data||pg/ml||Standard Deviation|Mean
797868|NCT00943787|Primary|Maximum Epinephrine Response (LBGI Groups)|"Mean maximum epinephrine response during induced hypoglycemia is the average of subjects' maximum concentration of all epinephrine measurements taken at plasma glucose level lower than 70mg/dL.
Low blood glucose index (LBGI) is a metric to calculate the risk for hypoglycemia based on frequency and extent of past events based on SMBG readings. In studies, the LBGI typically accounted for 40–55% of the variance of future significant hypoglycemia in the subsequent 3–6 months. The LBGI has established risk categories: Low Risk, LBGI < 2.5; Moderate Risk, 2.5 < LBGI < 5; and High Risk, LBGI > 5, indicating an over 10-fold increase in future severe hypoglycemia from the lowest to the highest risk category."|285 min (time of clamp)|3 participants did not have adequate epinephrine data.||pg/ml||Standard Deviation|Mean
797869|NCT00943826|Secondary|Number of Participants With Non-Serious Adverse Events, Serious Adverse Events and Death|An adverse event (AE) was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as AE.A serious adverse event (SAE) is any experience that suggests a significant hazard,contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. Non-serious adverse events (Non-SAEs) included all AEs except SAEs (non-SAEs = all AEs – SAEs). Nine participants randomized to the Placebo+RT+Temozolomide arm incorrectly received at least 1 dose of bevacizumab and were added to the Bevacizumab+RT+Temozolomide arm for Safety.|Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])|Safety Population included all randomized participants who received study treatment during the treatment period (10 participants did not receive at least one dose of study treatment and were therefore excluded, 4 in Placebo and 6 in Bevacizumab.||Participants|||Number
797882|NCT00943878|Primary|Number of Participants Reporting Solicited Quantitative Local Reactions After the First H1N1 Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Within 8 days (Day 0-7) post first H1N1 vaccination|Participants who received the first H1N1 vaccination are included. Analyses are as treated.||Participants|||Number
797883|NCT00943878|Primary|Number of Participants Reporting Solicited Subjective Local Reactions After the Second Placebo Vaccination|Participants maintained a memory aid to record daily the occurrence of local symptoms of pain, tenderness and swelling for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days. The second placebo vaccination was given on Study Day 21 for Groups 1 and 4, on Study Day 42 for Groups 2 and 3.|Within 8 days (Day 0-7) post second placebo vaccination|Participants who received the second placebo vaccination are included. Analyses are as treated.||Participants|||Number
797870|NCT00943826|Secondary|PFS in Participants With Stable/Improved Health Related Quality of Life (HRQoL) Based on European Organization for Research & Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Core 30 (C30)(EORTC QLQ-C30) & EORTC QLQ Brain Neoplasm 20 (BN20)|EORTC QLQ-C30: 30 items; 5 functional scales; 9 symptom scales; & global health status. Most questions used 4-point scale (1:Not at all, 4:Very much), 2 questions used 7-point scale (1:very poor, 7:Excellent). EORTC QLQ-BN20: 20 items rated on a 4 point scale (1:not at all, 4:very much). EORTC QLQ-C30 and BN20 scores were transformed to a 0-100 scale, higher score=better functioning/global health (C30) or more severe symptoms (BN20). Stable HRQoL: change from baseline (BL) within 10 points. Improved HRQoL: an increase from BL >/=10 points for functioning/global health status, & decrease of >/=10 points for symptoms. PFS is reported for participants with Stable/Improved global health; physical, social functioning (C30); motor dysfunction & communication deficit (BN20). PFS: randomization to PD or death. PD: >=25% increase in sum of products of longest diameters of index lesions; or progression of existing non-index lesions; or appearance of new lesions; or neurological worsening.|Randomization until PFS Event [Until data cutoff= 31 March 2012 (up to 31.4 months)|Intent to treat population. Number of Participants Analyzed = overall participants evaluable for this outcome measure; n = participants evaluable for specified category.||Months||Full Range|Median
797871|NCT00943826|Secondary|Kaplan-Meier (KM) Estimate of Two Year Overall Survival|KM estimate of two year overall survival was reported (probability to survive for at least 2 years). Corresponding 95% CI was calculated using Greenwood’s formula.|Randomization until Overall Survival Event (Until data cutoff= 28 February 2013 [up to 42.2 months])|Intent to treat population.||probability of being alive||95% Confidence Interval|Number
797872|NCT00943826|Secondary|Kaplan-Meier (KM) Estimate of One Year Overall Survival|KM estimate of one year overall survival (probability to survive for at least 1 year) was reported. Corresponding 95% confidence interval (CI) was calculated using Greenwood's formula.|Randomization until Overall Survival Event (Until data cutoff= 28 February 2013 [up to 42.2 months])|Intent to treat population.||probability of being alive||95% Confidence Interval|Number
797873|NCT00943826|Secondary|PFS as Assessed by an Independent Review Facility|An Independent Review Facility reviewed the MRI scans used by investigator to evaluate radiological tumor response. PFS is defined as time from randomization to PD or death. PD was assessed using adapted Macdonald response (modified WHO) criteria based on 3 components: radiological tumor assessments using MRI scans, neurological assessment and changes in corticosteroid use. PD is assessed as >=25% increase in sum of products of the longest diameters of all index lesions (enhancing, measurable) compared with the smallest recorded sum (nadir); or unequivocal PD of existing non-index lesions (non-enhancing and enhancing, non-measurable); or unequivocal appearance of new lesions); or neurological worsening (if corticosteroid dose is stable or increased) compared to neurological evaluation at previous disease assessment with no need for a confirmatory scan. Participants without a PFS event were censored at last disease assessment.|Randomization until PFS Event (Until data cutoff= 31 March 2012 [up to 29.5 months])|Intent to treat population.||Months||95% Confidence Interval|Median
797874|NCT00943826|Primary|Co-Primary: Overall Survival (OS)|Overall Survival was defined as the time from randomization to death due to any cause.|Randomization until OS Event (Until data cutoff= 28 February 2013 [up to 42.2 months])|Intent to treat population.||Months||95% Confidence Interval|Median
797875|NCT00943826|Primary|Co-Primary: Progression-free Survival (PFS) as Assessed by Investigator|PFS is defined as time from randomization to disease progression (PD) or death. PD was assessed using adapted Macdonald response criteria (modified World Health Organization [WHO] criteria) based on 3 components: radiological tumor assessments using Magnetic Resonance Imaging [MRI] scans,neurological assessment and changes in corticosteroid use. PD is assessed as greater than or equal to(>=) 25% increase in sum of products of the longest diameters of all index lesions (enhancing,measurable) compared with the smallest recorded sum (nadir); or unequivocal PD of existing non-index lesions (non-enhancing and enhancing,non-measurable); or unequivocal appearance of new lesions); or neurological worsening (if corticosteroid dose is stable or increased) compared to neurological evaluation at previous disease assessment with no need for a confirmatory scan. Participants without a PFS event were censored at last disease assessment.|Randomization until PFS Event [Until data cutoff= 31 March 2012 (up to 31.4 months)|Intent to treat population.||Months||95% Confidence Interval|Median
797876|NCT00943852|Primary|Mean Augmentation Index Percent Change From Baseline After Single Doses of Losartan 100 mg + ISMN 60 mg Versus Single Dose of Placebo|"The augmentation index (AIx) is defined as the ratio of augmentation (Δ P) to central pulse pressure and expressed as percent. AIx = (ΔP/PP) x 100, where P =
pressure and PP = Pulse Pressure. A mathematical transfer function translated the peripheral wave form into a central waveform using an FDA approved process based on directly recorded arterial pressure values. The mean AIx for each subject was estimated as a time-weighted average over the 10-hour post dose observation period and expressed as a change from baseline."|Baseline and 10 hours postdose|All subjects who received single doses of Losartan 100 mg + ISMN 60 mg and/or single dose of placebo||Percent Change||Standard Deviation|Least Squares Mean
797877|NCT00943852|Primary|Mean Augmentation Index Percent Change From Baseline After Single Doses of Losartan 100 mg Plus ISMN 60 mg Versus Single Dose of Losartan 100 mg|The augmentation index (AIx) is defined as the ratio of augmentation (Δ P) to central pulse pressure and expressed as percent. AIx = (ΔP/PP) x 100, where P = pressure and PP = Pulse Pressure. A mathematical transfer function translated the peripheral wave form into a central waveform using an FDA approved process based on directly recorded arterial pressure values. The mean AIx for each subject was estimated as a time-weighted average over the 10-hour post dose observation period and expressed as a change from baseline.|Baseline and 10 hours postdose|All subjects who received single doses of losartan 100 mg + ISMN 60 mg and/or single dose of losartan 100 mg||Percent Change||Standard Deviation|Least Squares Mean
797878|NCT00943878|Primary|Number of Participants Reporting Solicited Quantitative Local Reactions After the Second Placebo Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Within 8 days (Day 0-7) post second placebo vaccination|Participants who received the second placebo vaccination are included. Analyses are as treated.||Participants|||Number
799588|NCT00957424|Primary|Number of Participants Willing to Continue With Preferred HRP||1 week follow up|Those who completed one-week multiple product sampling||participants|||Number
797884|NCT00943878|Primary|Number of Participants Reporting Solicited Subjective Local Reactions After the First Placebo Vaccination|Participants maintained a memory aid to record daily the occurrence of local symptoms of pain, tenderness and swelling for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days. The first placebo vaccination was given on Study Day 0 for Groups 1, 3 and 4, and on Study Day 21 for Group 2.|Within 8 days (Day 0-7) post first placebo vaccination|Participants who received the first placebo vaccination are included. Analyses are as treated.||Participants|||Number
797885|NCT00943878|Primary|Number of Participants Reporting Solicited Subjective Local Reactions After the TIV Vaccination|Participants maintained a memory aid to record daily the occurrence of local symptoms of pain, tenderness and swelling for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days. The TIV vaccination was given on Study Day 42 for Group 1, Study Day 0 for Groups 2 and 4, and on Study Day 21 for Group 3.|Within 8 days (Day 0-7) post TIV vaccination|Participants who received the TIV vaccination are included. Analyses are as treated.||Participants|||Number
797886|NCT00943878|Primary|Number of Participants Reporting Solicited Subjective Local Reactions After the Second H1N1 Vaccination|Participants maintained a memory aid to record daily the occurrence of local symptoms of pain, tenderness and swelling for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days. Second H1N1 vaccination was given on Study Day 21 for Groups 1, 2 and 3, and on Study Day 42 for Group 4.|Within 8 days (Day 0-7) post second H1N1 vaccination|Participants who received the second H1N1 vaccination are included. Analyses are as treated.||Participants|||Number
797887|NCT00943878|Primary|Number of Participants Reporting Solicited Subjective Local Reactions After the First H1N1 Vaccination|Participants maintained a memory aid to record daily the occurrence of local symptoms of pain, tenderness and swelling for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days. First H1N1 vaccination was given on Study Day 0 for Groups 1, 2 and 3, and on Study Day 21 for Group 4.|Within 8 days (Day 0-7) post first H1N1 vaccination|Participants who received the first H1N1 vaccination are included. Analyses are as treated.||Participants|||Number
797888|NCT00943878|Primary|Number of Participants Reporting Fever After the Third Vaccination|Participants were provided a thermometer and a memory aid to record daily oral temperatures for 8 days (Day 0-7) after vaccination. Participants are counted as experiencing fever if they reported oral temperatures of 38 degrees Celsius or higher on any of the 8 days.|Within 8 days (Day 0-7) post third vaccination|Participants who received the third vaccination and reported oral temperatures during the time period are included. Analyses are as treated.||Participants|||Number
797889|NCT00943878|Primary|Number of Participants Reporting Fever After the Second Vaccination|Participants were provided a thermometer and a memory aid to record daily oral temperatures for 8 days (Day 0-7) after vaccination. Participants are counted as experiencing fever if they reported oral temperatures of 38 degrees Celsius or higher on any of the 8 days.|Within 8 days (Day 0-7) post second vaccination|Participants who received the second vaccination and reported oral temperatures during the time period are included. Analyses are as treated.||Participants|||Number
797890|NCT00943878|Primary|Number of Participants Reporting Fever After the First Vaccination|Participants were provided a thermometer and a memory aid to record daily oral temperatures for 8 days (Day 0-7) after vaccination. Participants are counted as experiencing fever if they reported oral temperatures of 38 degrees Celsius or higher on any of the 8 days.|Within 8 days (Day 0-7) post first vaccination|Participants who received the first vaccination and reported oral temperatures during the time period are included. Analyses are as treated.||Participants|||Number
797891|NCT00943878|Primary|Number of Participants Reporting Solicited Subjective Systemic Reactions After the Third Vaccination|Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Within 8 days (Day 0-7) post third vaccination|Participants who received the third vaccination are included. Analyses are as treated.||Participants|||Number
797892|NCT00943878|Primary|Number of Participants Reporting Solicited Subjective Systemic Reactions After the Second Vaccination|Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Within 8 days (Day 0-7) post second vaccination|Participants who received the second vaccination are included. Analyses are as treated.||Participants|||Number
797893|NCT00943878|Secondary|Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. For Group 4, this timepoint is Study Day 63, all others it is Study Day 42. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after second H1N1 vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Three participants were excluded due to receipt of non-study vaccines. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
797913|NCT00944021|Secondary|Pharmacokinetics- Terminal Elimination Phase Half-life (t1/2) (Day 14).||0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 24 and 30 hours post-dose on Day 14 of 14 consecutive days of treatment|All PA-824 patients who received at least one administration of the investigational drug, had at least one measured concentration after the start of treatment for at least one PK analysis and had no major events affecting the integrity of the PK data.||hour||Standard Deviation|Mean
798102|NCT00945893|Secondary|Number of Participants Reporting AEs Within 14 Days Post Vaccination, Dose 1||Days 1-15|The Safety Population was defined as all participants who received at least one dose of investigational product and had any follow-up for safety.||Participants|||Number
797894|NCT00943878|Secondary|Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. For Group 4, this timepoint is Study Day 63, all others it is Study Day 42. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after second H1N1 vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Eight participants were excluded due to eligibility deviations, vaccine administration error or other protocol deviations. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
797895|NCT00943878|Secondary|Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination|Blood was collected from participants 21 days after the last vaccination for testing in the HAI assay against each strain in the 2009-2010 trivalent influenza vaccine. Each sample was tested according to standard operating procedures. A participant is counted if the value at the Day 63 timepoint was 1:40 or greater.|Day 63|Participants who received all scheduled vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Three participants were excluded due to receipt of non-study vaccines. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
797896|NCT00943878|Secondary|Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination|Blood was collected from participants 21 days after the last vaccination for testing in the HAI assay against each strain in the 2009-2010 trivalent influenza vaccine. Each sample was tested according to standard operating procedures. A participant is counted if the value at the Day 63 timepoint was 1:40 or greater.|Day 63|Participants who received all scheduled vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Eight participants were excluded due to eligibility deviations, vaccine administration error or other protocol deviations. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
797897|NCT00943878|Primary|Number of Participants Reporting Solicited Subjective Systemic Reactions After the First Vaccination|Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Within 8 days (Day 0-7) post first vaccination|Participants who received the first vaccination are included. Analyses are as treated.||Participants|||Number
797898|NCT00943878|Primary|Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more. Day 21 post first H1N1 vaccination is Study Day 42 for Group 4, and is Study Day 21 for all other groups.|Day 0 prior to vaccination and 21 days after the first H1N1 vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint are included. One participant was excluded due to receipt of a non-study vaccine. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
797899|NCT00943878|Secondary|Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more. Day 21 post second H1N1 vaccination is Study Day 63 for Group 4, and is Study Day 42 for all other groups.|Day 0 prior to vaccination and 21 days after the second H1N1 vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Three participants were excluded due to receipt of non-study vaccines. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
797900|NCT00943878|Secondary|Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more. Day 21 post second H1N1 vaccination is Study Day 63 for Group 4, and is Study Day 42 for all other groups.|Day 0 prior to vaccination and 21 days after the second H1N1 vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Eight participants were excluded due to eligibility deviations, vaccine administration error or other protocol deviations. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
797914|NCT00944021|Secondary|Pharmacokinetics-Maximum Observed Plasma Concentration (Cmax) (Day 14).||0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12,16, 24, and 30 hours post-dose on Day 14 of 14 consecutive days of treatment|All PA-824 patients who received at least one administration of the investigational drug, had at least one measured concentration after the start of treatment for at least one PK analysis and had no major events affecting the integrity of the PK data.||ng/mL||Standard Deviation|Mean
799589|NCT00957424|Primary|Number of Participants That Completed 1-week Trial||One week|||participants|||Number
797901|NCT00943878|Secondary|Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination|Blood was collected from participants for testing in the HAI assay against each strain in the 2009-2010 trivalent influenza vaccine. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 63 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 63 titer was an increase by 4-fold or more.|Day 63|Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Three participants were excluded due to receipt of non-study vaccines. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
797902|NCT00943878|Secondary|Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination|Blood was collected from participants for testing in the HAI assay against each strain in the 2009-2010 trivalent influenza vaccine. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 63 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 63 titer was an increase by 4-fold or more.|Day 63|Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Eight participants were excluded due to eligibility deviations, vaccine administration error or other protocol deviations. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
797903|NCT00943878|Primary|Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more. Day 21 post first H1N1 vaccination is Study Day 42 for Group 4, and is Study Day 21 for all other groups.|Day 0 prior to vaccination and 21 days after the first H1N1 vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint, both within 4 days of the window, are included. Seven participants were excluded due to eligibility deviations, vaccine administration error or other protocol deviations. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
797904|NCT00943878|Primary|Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)|Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof; resulted in a congenital anomaly/birth defect; may have jeopardized the participant or required intervention to prevent one of these outcomes; or was described as Guillain-Barré Syndrome. Association to vaccination was determined by a study clinician licensed to make medical diagnoses.|Day 0 through Day 180 after the last vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated.||Participants|||Number
797905|NCT00943878|Primary|Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. For Group 4, this timepoint is Study Day 42, all others it is Study Day 21. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after first H1N1 vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint, both within 4 days of the window, are included. One participant was excluded due to receipt of a non-study vaccine. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
797906|NCT00943878|Primary|Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. For Group 4, this timepoint is Study Day 42, all others it is Study Day 21. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after first H1N1 vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint, both within 4 days of the window, are included. Seven participants were excluded due to eligibility deviations, vaccine administration error or other protocol deviations. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
797907|NCT00943917|Primary|Mean Change in HbA1c (ITT)|Mean change in HbA1c through Week 48|Day 0 to Week 48|Intent to treat analysis||percent change||Standard Deviation|Mean
797908|NCT00943917|Primary|Mean Change in HbA1c (Per Protocol)|Mean change in HbA1c through Week 48|Day 0 to Week 48|Per protocol - Only subjects with values at baseline and Week 48 endpoint are included.||percent change||Standard Deviation|Mean
797909|NCT00943917|Primary|Mean Change in HbA1c (ITT)|Mean change in HbA1c through Week 24|Day 0 to Week 24|Intent to treat analysis||percent change||Standard Deviation|Mean
797910|NCT00943917|Primary|Mean Change in HbA1c (Per Protocol)|Mean change in HbA1c through Week 24|Day 0 to Week 24|Per protocol analysis - Only subjects with values at baseline and Week 24 endpoint are included.||percent change||Standard Deviation|Mean
797911|NCT00943917|Primary|Mean Change in HbA1c (ITT)|Mean change in HbA1c through Week 12|Day 0 to Week 12|Intent to treat analysis||percent change||Standard Deviation|Mean
797912|NCT00943917|Primary|Mean Change in HbA1c (Per Protocol)|Mean change in HbA1c over first 12 weeks (Stage I)|Day 0 and Week 12|Per protocol analysis- Only subjects with values at baseline and Week 12 endpoint are included.||percent change||Standard Deviation|Mean
799590|NCT00957424|Primary|Number of Participants Willing to Try HRPs||Baseline|||participants|||Number
797916|NCT00944021|Secondary|Pharmacokinetics- Area Under the Plasma Concentration Time Curve From Zero to Infinity (AUC 0 to Infinity) (Day 1).||0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, and 24 hours post-dose on Day 1 of treatment|All PA-824 patients who received at least one administration of the investigational drug, had at least one measured concentration after the start of treatment for at least one PK analysis and had no major events affecting the integrity of the PK data.||ng * hour/mL||Standard Deviation|Mean
797917|NCT00944021|Secondary|Pharmacokinetics- Maximum Observed Plasma Concentration (Cmax) (Day 1).||0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, and 24 hours post-dose on Day 1 of treatment|All PA-824 patients who received at least one administration of the investigational drug, had at least one measured concentration after the start of treatment for at least one PK analysis and had no major events affecting the integrity of the PK data.||ng/mL||Standard Deviation|Mean
797918|NCT00944021|Secondary|Rate of Change in Increased Time to Sputum Culture Positivity (TTP)(Hours) in Liquid Culture Media (Days 2-14).||Days 2-14 of 14 consecutive days of treatment|All randomized subjects. Some of the TTP values could not be calculated due to missing results. The population is the number of patients for whom the results were available for this time period and therefore for whom the relevant TTP could be calculated.||hours/day||Standard Deviation|Mean
797919|NCT00944021|Secondary|Rate of Change in Increased Time to Sputum Culture Positivity (TTP)(Hours) in Liquid Culture Media (Days 0-2).||Two consecutive days of treatment|All randomized subjects. Some of the TTP values could not be calculated due to missing results. The population is the number of patients for whom the results were available for this time period and therefore for whom the relevant TTP could be calculated.||hours/day||Standard Deviation|Mean
797920|NCT00944021|Secondary|Rate of Change in Increased Time to Sputum Culture Positivity (TTP)(Hours) in Liquid Culture Media (Days 0-14).||Fourteen consecutive days of treatment|All randomized subjects. Some of the TTP values could not be calculated due to missing results. The population is the number of patients for whom the results were available for this time period and therefore for whom the relevant TTP could be calculated.||hours/day||Standard Deviation|Mean
797921|NCT00944021|Secondary|Early Bactericidal Activity (EBA) Measured as the Mean Rate of Reduction of log10 Colony Forming Units (CFU) of M. Tuberculosis Per ml Sputum on Solid Medium Over Time (Days 2-14).||Days 2-14 of 14 consecutive days of treatment|All randomized subjects. Some of the EBA values could not be calculated due to missing results. The analysis population is the number of patients for whom the results were available for this time period and therefore for whom the relevant EBA could be calculated.||log10CFU/ml/day||Standard Deviation|Mean
797922|NCT00944021|Secondary|Early Bactericidal Activity (EBA) Measured as the Mean Rate of Reduction of log10 Colony Forming Units (CFU) of M. Tuberculosis Per ml Sputum on Solid Medium Over Time (Days 0-2).||Two consecutive days of treatment|All randomized subjects. Some of the EBA values could not be calculated due to missing results. The analysis population is the number of patients for whom the results were available for this time period and therefore for whom the relevant EBA could be calculated.||log10CFU/ml/day||Standard Deviation|Mean
797923|NCT00944021|Primary|Early Bactericidal Activity (EBA) Measured as the Mean Rate of Reduction of log10 Colony Forming Units (CFU) of M. Tuberculosis Per ml Sputum on Solid Medium Over Time (Days 0-14).||14 consecutive days of treatment|All randomized subjects. Some of the EBA values could not be calculated due to missing results. The analysis population is the number of patients for whom the results were available for this time period and therefore for whom the relevant EBA could be calculated.||log10CFU/ml/day||Standard Deviation|Mean
797924|NCT00944034|Secondary|Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Two-dose Catch-up Regimen of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.|The safety and tolerability of the two-dose catch-up regimen of rMenB+OMV NZ vaccine in children (12, 18 or 24 months age) is reported as number of subjects with solicited local and systemic adverse events.|day 1 to day 7 after vaccination|The analysis was done on safety population||participants|||Number
797925|NCT00944034|Secondary|Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Fourth Booster Dose of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.|The safety and tolerability of the 4th booster dose rMenB+OMV NZ vaccine in children (12, 18 or 24 months age) is reported as number of subjects with solicited local and systemic adverse events.|From day 1 to day 7 after vaccination|Analysis was done on the Safety Population.||participants|||Number
797926|NCT00944034|Secondary|Geometric Mean Concentrations Against Vaccine Antigen 287- 953 One Month After Booster Given After a Two-dose Catch-up Regimen in Toddlers Starting at 12, 18 or 24 Months of Age.|Immunogenicity evaluation against vaccine antigen 287-953 one month after booster given after a two-dose catch-up regimen in toddlers starting at 12, 18 or 24 months of age.one month after fourth booster dose to previously primed toddlers at 12, 18 or 24 months of age measured by ELISA|1 month after booster vaccination|The analysis was performed on the per-protocol population||IU/mL||95% Confidence Interval|Geometric Mean
797927|NCT00944034|Secondary|Geometric Mean Concentrations Against Vaccine Antigen 287- 953 One Month After Fourth Booster Dose to Previously Primed Toddlers at 12, 18 or 24 Months of Age.|Immunogenicity evaluation against vaccine antigen 287-953 one month after fourth booster dose to previously primed toddlers at 12, 18 or 24 months measured by ELISA.|1 month after booster vaccination|The analysis was performed on the per-protocol population||IU/mL||95% Confidence Interval|Geometric Mean
797928|NCT00944034|Secondary|Two-dose Catch-up Regimen of rMenB+OMV NZ in Unprimed Toddlers Aged 12, 18 or 24 Months|Immunogenicity evaluation of a two-dose catch-up regimen of rMenB+OMV NZ in unprimed toddlers aged 12, 18 or 24 months as measured by serum antibody titers one month after the second vaccination f meningococcal B vaccine at 18 and 24months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ reported as geometric mean titers (GMTs) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99.|1 month after second vaccination|The analysis was performed on the per-protocol population||Titers||95% Confidence Interval|Geometric Mean
797953|NCT00944073|Primary|Number of Participants Age 36 Months to 9 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 0|Blood was collected from all participants prior to vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 0|All participants with blood collected at the timepoint are included. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
797929|NCT00944034|Secondary|GMTs in Subjects One Month After the Fourth (Booster) Dose of Meningococcal B Vaccine at 18 and 24months of Age, Previously Vaccinated With 3 Doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 Months of Age and Single Dose of rMenB+OMV NZ Given at Same Age|Characterization of immunological memory by serum antibody titers one month after the fourth (booster) dose of meningococcal B vaccine at 18 and 24months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 months of age and single dose of rMenB+OMV NZ given at same ages, are reported as geometric mean titers (GMTs) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99.|1 month after booster|The analysis was performed on the per-protocol population. For hSBA≥ 1: 5 (H44/76 strain)(N=116 101 111 93 56 48 46 52), hSBA≥ 1: 5 (5/99 strain) (N=118 100 110 92 56 46 48 50), hSBA≥ 1: 5 (NZ 98/254 strain) (N=118 103 111 95 56 48 47 50)||Titers||95% Confidence Interval|Geometric Mean
797930|NCT00944034|Secondary|GMTs in Subjects One Month After the Fourth (Booster) Dose of Meningococcal B Vaccine at 12 Months of Age Previously Vaccinated With 3 Doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 Months of Age and Single Dose of rMenB+OMV NZ Given at Same Age|Characterization of immunological memory by serum antibody titers (98.3% CI) one month after the fourth (booster) dose of meningococcal B vaccine at 12 months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 months of age and single dose of rMenB+OMV NZ given at same ages, are reported as geometric mean titers (GMTs) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99.|1 month after booster|The analysis was performed on the per-protocol population||Titers||95% Confidence Interval|Geometric Mean
797931|NCT00944034|Secondary|Geometric Mean Titers (GMTs) in Subjects One Month After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in Subjects at 12 18 or 24 Months of Age Who Previously Received 3 Doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 Months of Age.|The serum antibody titers one month after the fourth (booster) dose of meningococcal B vaccine at 12 or 18 or24 months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 months of age, are reported as geometric mean titers (GMTs) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99.|1 month after booster|The analysis was performed on the per-protocol population. For hSBA≥ 1: 5 (H44/76 strain) (N=158 116 101 138 111 93 83 56 48) For hSBA≥ 1: 5 (5/99 strain) (N=156 118 100 142 110 92 84 56 46) For hSBA≥ 1: 5 (NZ 98/254 strain) (N=159 118 103 142 111 95 86 56 48) For hSBA≥ 1: 5 (M10713 strain) (N=0 0 0 0 0 0 67 50 41)||Titers||95% Confidence Interval|Geometric Mean
797932|NCT00944034|Secondary|Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in Subjects Who Previously Received 3 Doses of rMenB+OMV NZ and Routine Vaccines at 2, 3 and 4 Months of Age.|Immunogenicity was assessed in terms of percentage of subjects with serum bactericidal antibody (SBA) titers ≥1:5 (98.3% CI) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99, one month after the fourth (booster) dose of meningococcal B vaccine at 12 or 18 or24 months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ and routine vaccines at 2, 3 and 4 months of age.|1 month after booster|The analysis was performed on the per-protocol population||percentage of subjects||95% Confidence Interval|Number
797933|NCT00944034|Secondary|Percentages of Subjects With SBA Titers ≥1:5 After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in Subjects Who Previously Received 3 Doses of rMenB+OMV NZ at 2, 4 and 6 Months of Age and Routine Vaccines at 3, 5 and 7 Months of Age.|Immunogenicity was assessed in terms of Percentages of Subjects With SBA Titers ≥1:5 (98.3% CI), After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in subjects who previously received 3 doses of rMenB+OMV NZ at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age.|1 month after booster|The analysis was performed on per-protocol population. This outcome measure was assessed only against H44/76, NZ98/254 and 5/99 strains. As exploratory analyses were performed on the M10713 strain, no endpoints were considered for this strain.||percentage of subjects||98.3% Confidence Interval|Number
797934|NCT00944034|Primary|Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in Subjects Who Previously Received 3 Doses of rMenB+OMV NZ and Routine Vaccines at 2, 4 and 6 Months of Age.|Immunogenicity was assessed in terms of percentage of subjects with serum bactericidal antibody (SBA) titers ≥1:5 (98.3% CI) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99, one month after the fourth (booster) dose of meningococcal B vaccine at 12 or 18 or24 months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ and routine vaccines at 2, 4 and 6 months of age.|1 month after booster|The analysis was performed on the per-protocol population. This outcome measure was assessed only for the strains H44/76, NZ98/254 and 5/99. As exploratory analyses were performed on the M10713 strain, no endpoints were considered for this strain.||percentage of subjects||98.3% Confidence Interval|Number
797935|NCT00944073|Secondary|Number of Participants Age 10 to 17 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 21 Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants enrolled in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to first vaccination and Day 21 after the second vaccination|All participants who received the second vaccination and had blood collected at the timepoint both within 7 days of the visit window are included. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
797936|NCT00944073|Secondary|Number of Participants Age 10 to 17 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 8-10 Following the Second Dose of H1N1 Vaccine|Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more.|Day 0 prior to first vaccination and Day 8-10 after the second vaccination|All participants who received the second vaccination within 7 days of the visit window and had blood collected at the timepoint are included. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
799591|NCT00957424|Primary|Number of Participants With no Interest in Trial of Harm-reduction Products (HRPs)||Baseline|||participants|||Number
797937|NCT00944073|Secondary|Number of Participants Age 36 Months to 9 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 21 Following the Second Dose of H1N1 Vaccine|Blood was to be collected from participants enrolled after the first 30 in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to first vaccination and Day 21 after the second vaccination|Participants who received the second vaccination and had blood collected at the timepoint both within 7 days of the visit window are included. One participant is excluded due to vaccine administration error. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
797938|NCT00944073|Secondary|Number of Participants Age 36 Months to 9 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 8-10 Following the Second Dose of H1N1 Vaccine|Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more.|Day 0 prior to first vaccination and Day 8-10 after the second vaccination|All participants who received the second vaccination within 7 days of the visit window and had blood collected at the timepoint are included. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
797939|NCT00944073|Secondary|Number of Participants Age 6 to Less Than 36 Months With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 21 Following the Second Dose of H1N1 Vaccine|Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to first vaccination and Day 21 after the second vaccination|Participants who received the second vaccination and had blood collected at the timepoint both within 7 days of the visit window are included. Two are excluded due to receipt of non-study vaccines, two due to vaccine administration errors and 1 due to a sample labeling error. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
797940|NCT00944073|Secondary|Number of Participants Age 6 to Less Than 36 Months With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 8-10 Following the Second Dose of H1N1 Vaccine|Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more.|Day 0 prior to first vaccination and Day 8-10 after the second vaccination|All participants who received the second vaccination within 7 days of the visit window and had blood collected at the timepoint are included. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
797941|NCT00944073|Secondary|Number of Participants Age 10 to 17 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 21 Following the Second Dose of H1N1 Vaccine|Blood was to be collected from all participants enrolled in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the second vaccination|All participants who received the second vaccination and had blood collected at the timepoint both within 7 days of the visit window are included. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
797942|NCT00944073|Secondary|Number of Participants Age 10 to 17 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 8-10 Following the Second Dose of H1N1 Vaccine|Blood was to be collected from all participants enrolled in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 8-10 after the second vaccination|All participants who received the second vaccination within 7 days of the visit window and had blood collected at the timepoint are included. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
797943|NCT00944073|Secondary|Number of Participants Age 36 Months to 9 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 21 Following the Second Dose of H1N1 Vaccine|Blood was to be collected from participants enrolled after the first 30 in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the second vaccination|Participants who received the second vaccination and had blood collected at the timepoint both within 7 days of the window are included. One participant is excluded due to vaccine administration error. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
797952|NCT00944073|Primary|Number of Participants Age 36 Months to 9 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 8-10 Following a Single Dose of H1N1 Vaccine|Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 8-10|All participants with blood collected at the timepoint are included. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
797944|NCT00944073|Secondary|Number of Participants Age 36 Months to 9 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 8-10 Following the Second Dose of H1N1 Vaccine|Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 8-10 after the second vaccination|All participants who received the second vaccination within 7 days of the visit window and had blood collected at the timepoint are included. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
797945|NCT00944073|Primary|Number of Participants Age 10 to 17 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Days 8-10 and 21 Following a Single Dose of H1N1 Vaccine|Blood was to be collected from all participants enrolled in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 or Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 or Day 21 titer was an increase by 4-fold or more.|Day 0 prior to and Days 8-10 and 21 after first vaccination|All participants with blood collected at the timepoints are included. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
797946|NCT00944073|Primary|Number of Participants Age 36 Months to 9 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 21 Following a Single Dose of H1N1 Vaccine|Blood was to be collected from participants enrolled after the first 30 in each dose group in this age stratum, for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to and Day 21 after first vaccination|All participants with blood collected at both timepoints are included. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
797947|NCT00944073|Primary|Number of Participants Age 36 Months to 9 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 8-10 Following a Single Dose of H1N1 Vaccine|Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more.|Day 0 prior to and Day 8-10 after first vaccination|All participants with blood collected at both timepoints are included. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
797948|NCT00944073|Primary|Number of Participants Age 6 to Less Than 36 Months With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 21 Following a Single Dose of H1N1 Vaccine|Blood was to be collected from participants enrolled after the first 30 in each dose group in this age stratum, for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to and Day 21 after first vaccination|Participants with blood collected at both timepoints are included. Analyses are as treated. This outcome restricts to age stratum. One participant was excluded due to the Day 21 blood draw being greater than 7 days out of window.||Participants|||Number
797949|NCT00944073|Primary|Number of Participants Age 6 to Less Than 36 Months With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 8-10 Following a Single Dose of H1N1 Vaccine|Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more.|Day 0 prior to and Day 8-10 after first vaccination|All participants with blood collected at both timepoints are included. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
797950|NCT00944073|Primary|Number of Participants Age 10 to 17 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 0 and at Days 8-10 and 21 Following a Single Dose of H1N1 Vaccine|Blood was collected from all participants prior to vaccination and at Days 8-10 and 21 for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 0 prior to vaccination and Days 8-10 and 21 after first vaccination|All participants with blood collected at baseline and with at least one evaluable time point after vaccination are included. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
797951|NCT00944073|Primary|Number of Participants Age 36 Months to 9 Years Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 21 Following a Single Dose of H1N1 Vaccine|Blood was to be collected from participants enrolled after the first 30 in each dose group in this age stratum, for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21|All participants with blood collected at the timepoint within 7 days of the visit window are included. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
798103|NCT00945893|Secondary|Number of Participants With Any Solicited Symptom Within 14 Days Post Vaccination, Dose 1||Days 1-15|The Safety Population for solicited symptoms was defined as all participants who received at least one dose of investigational product, had any follow-up for safety and had solicited symptom data available during the reporting period.||Participants|||Number
797954|NCT00944073|Primary|Number of Participants Age 6 to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 21 Following a Single Dose of H1N1 Vaccine|Blood was to be collected from participants enrolled after the first 30 in each dose group in this age stratum, for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21|Participants with blood collected at the timepoint are included. Analyses are as treated. This outcome restricts to age stratum. One participant was excluded due to the Day 21 blood draw being greater than 7 days out of window.||Participants|||Number
797955|NCT00944073|Primary|Number of Participants Age 6 to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 8-10 Following a Single Dose of H1N1 Vaccine|Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 8-10|All participants with blood collected at the timepoint are included. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
797956|NCT00944073|Primary|Number of Participants Age 6 to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 0|Blood was collected from all participants prior to vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 0|All participants with blood collected at the timepoint are included. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
797957|NCT00944073|Primary|Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)|Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof; resulted in a congenital anomaly/birth defect; or may have jeopardized the participant or required intervention to prevent one of these outcomes. Association to vaccination was determined by a study clinician licensed to make medical diagnoses.|Day 0 through Day 180 after last vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated.||Participants|||Number
797958|NCT00944073|Primary|Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the Second Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, myalgia, headache, nausea, decreased general activity, and malaise for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.|Day 0-7 after second vaccination|All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
797959|NCT00944073|Primary|Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the First Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, myalgia, headache, nausea, decreased general activity, and malaise for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.|Day 0-7 after first vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
797960|NCT00944073|Primary|Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Systemic Reactions After the Second Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, myalgia, headache, nausea and decreased general activity for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.|Day 0-7 after second vaccination|All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
797961|NCT00944073|Primary|Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Systemic Reactions After the First Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, myalgia, headache, nausea and decreased general activity for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.|Day 0-7 after first vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
797962|NCT00944073|Primary|Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Systemic Reactions After the Second Vaccination|Participants' parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of irritability, decreased appetite and lethargy for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.|Day 0-7 after second vaccination|All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
797973|NCT00944229|Primary|Change in Base Line Oxidized Low Density Lipoprotein (LDL) Level and in Response to Exercise||0, 1 and 8 weeks of Omega 3 supplementation.|The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in March 2013.|||||
797963|NCT00944073|Primary|Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Systemic Reactions After the First Vaccination|Participants' parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of irritability, decreased appetite and lethargy for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.|Day 0-7 after first vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
797964|NCT00944073|Primary|Number of Participants Reporting Solicited Quantitative Systemic Reactions After the Second Vaccination|Participants or their parents/guardians maintained a memory aid to record daily oral/axillary temperatures and the number of vomiting episodes, if experienced, for 8 days after vaccination (Day 0-7). Participants are counted as experiencing fever if they reported oral temperatures of 38.3 degrees Celsius or higher, or axillary temperatures of 37.8 degrees Celsius or higher, on any of the 8 days. Participants are counted as experiencing vomiting if they reported one or more episodes of vomiting on any of the 8 days.|Day 0-7 after second vaccination|All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated.||Participants|||Number
797965|NCT00944073|Primary|Number of Participants Reporting Solicited Quantitative Systemic Reactions After the First Vaccination|Participants or their parents/guardians maintained a memory aid to record daily oral/axillary temperatures and the number of vomiting episodes, if experienced, for 8 days after vaccination (Day 0-7). Participants are counted as experiencing fever if they reported oral temperatures of 38.3 degrees Celsius or higher, or axillary temperatures of 37.8 degrees Celsius or higher, on any of the 8 days. Participants are counted as experiencing vomiting if they reported one or more episodes of vomiting on any of the 8 days.|Day 0-7 after first vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated.||Participants|||Number
797966|NCT00944073|Secondary|Number of Participants Age 6 to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus Day 21 Following the Second Dose of H1N1 Vaccine|Blood was to be collected from participants enrolled after the first 30 in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the second vaccination|Participants who received the second vaccination and had blood collected at the timepoint both within 7 days of the window are included. Two are excluded due to receipt of non-study vaccines, two due to vaccine administration errors and 1 due to a sample labeling error. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
797967|NCT00944073|Secondary|Number of Participants Age 6 to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 8-10 Following the Second Dose of H1N1 Vaccine|Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 8-10 after the second vaccination|All participants who received the second vaccination within 7 days of the visit window and had blood collected at the timepoint are included. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
797968|NCT00944073|Primary|Number of Participants Reporting Solicited Quantitative Local Reactions After the Second Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Day 0-7 after second vaccination|All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated.||Participants|||Number
797969|NCT00944073|Primary|Number of Participants Reporting Solicited Quantitative Local Reactions After the First Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Day 0-7 after first vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated.||Participants|||Number
797970|NCT00944073|Primary|Number of Participants Reporting Solicited Subjective Local Reactions After the Second Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.|Day 0-7 after second vaccination|All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated.||Participants|||Number
797971|NCT00944073|Primary|Number of Participants Reporting Solicited Subjective Local Reactions After the First Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.|Day 0-7 after first vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated.||Participants|||Number
797972|NCT00944125|Primary|Change in Left Ventricular End Systolic Volume (LVESV)|The change in LVESV during the single and dual site LV pacing phases from baseline will be compared. The baseline for the second phase of the cross-over will be the end of phase one rather than the baseline done at time of randomization. Thus, the study will compare the incremental (or decremental) benefit of the alternate LV pacing configuration in each patient.|At 6 months to one year|Analysis population was based on the two randomized groups per the protocol.||ml||Standard Deviation|Mean
811703|NCT01059760|Primary|Change From Baseline in Participant Bicarbonate When Fasting and Fed||Baseline and 3 days|||mmol/L||Standard Deviation|Mean
797974|NCT00944229|Primary|Change in Reactive Hyperemia Peripheral Arterial Tonometry (RH-PAT) After 8 Weeks of Omega 3 Supplementation.||0 and after 8 weeks of Omega 3 supplementation.|The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in March 2013.|||||
797975|NCT00944229|Primary|Change in Peak VO2||0, 1 and 8 weeks of Omega 3 supplementation.|The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in March 2013.|||||
797976|NCT00944450|Primary|Peak Plasma Concentration (Cmax) Following Single Dose Administration of the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin)|Peak Plasma concentration (Cmax) for the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin)|Through 72 Hours Following the Administration of the Medication|Healthy Male and Female Subjects||μmol/L||Standard Deviation|Geometric Mean
797977|NCT00944450|Primary|Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin)|Area Under the Plasma Concentration-Time Curve and peak concentration of the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin)|Through 72 Hours Following the Administration of the Medication|Healthy Male and Female Subjects||μmol*hr/L||Standard Deviation|Geometric Mean
797978|NCT00944554|Primary|Days to Relapse|Number of days following the programmed lapse exposure until relapse to smoking occurred|4 weeks|||days||Standard Deviation|Mean
797979|NCT00944645|Primary|Maximum Concentration (Cmax) of Laropiprant|Measure of rate of absorption of laropiprant|Predose and up to 48 hours postdose|A linear mixed effect model was used to analyze laropiprant Cmax and uses data available from at least one treatment period. 166 subjects had data from the treatment of MK0524A New Site Tablet, and 167 subjects had data from the treatment of MK0524A Phase III Tablet.||micro Molar||Standard Deviation|Median
797980|NCT00944645|Primary|Area Under Curve (AUC 0-infinity) of Laropiprant|Measure of extent of absorption of laropiprant|Predose and up to 48 hours postdose|A linear mixed effect model was used to analyze laropiprant AUC0-infinity and uses data available from at least one treatment period. 166 subjects had data from the treatment of MK0524A New Site Tablet, and 167 subjects had data from the treatment of MK0524A Phase III Tablet||Micro Molar times Hour||Standard Deviation|Median
797981|NCT00944645|Primary|Total Amount of Urinary Excretion of Niacin and Its Metabolites|Measure of extent of absorption of ER niacin|Predose and up to 96 hours postdose|A linear mixed effect model was used to analyze total amount of urinary excretion of niacin and its metabolite and uses data available from at least one treatment period. 157 subjects had data from the treatment of MK0524A New Site Tablet, and 161 subjects had data from the treatment of MK0524A Phase III Tablet||micro mole||Standard Deviation|Median
797982|NCT00944645|Primary|Maximum Plasma Concentration (Cmax) of Nicotinuric Acid|Measure of rate of absorption of ER niacin|Predose and up to 24 hours postdose|The Hodges-Lehmann estimator was used to analyze nicotinuric acid Cmax and uses only subjects with data available on both treatment periods. 188 subjects were randomized,17 subjects discontinued, 26 subjects were inadvertently overdosed with 5 tablets of MK0524A 1000 mg/20 mg, reducing the available subject population for analysis to 145.||ng/mL||Inter-Quartile Range|Median
797983|NCT00944671|Secondary|Peak Plasma Concentration (Cmax) of Famotidine Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew With Water and Famotidine/Antacid Tablet With Water||Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose)|||ng/mL||95% Confidence Interval|Geometric Mean
797984|NCT00944671|Secondary|Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew With Water and Famotidine/Antacid Tablet With Water||Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose)|||ng*h/mL||95% Confidence Interval|Geometric Mean
797985|NCT00944671|Primary|Peak Plasma Concentration (Cmax) of Famotidine Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew Without Water and Famotidine/Antacid Tablet With Water||Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose)|||ng/mL||95% Confidence Interval|Geometric Mean
797986|NCT00944671|Primary|Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew Without Water and Famotidine/Antacid Tablet With Water||Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose)|||ng*hr/mL||95% Confidence Interval|Geometric Mean
797987|NCT00944697|Primary|Short Form McGill Pain Score.|The McGill Pain Score is the sum of the answers to three questions: A - describe your pain during the last week, 15 descriptors, (from 0 to 45 total), B – rate your pain during the last week (from 0 to 100), C: present pain intensity (0 to 5). Total pain score will be out of 150, with 0 being least pain and 150 being most pain.|Visit 2 (randomisation) and Visit 10 (end of study (12 weeks) or withdrawal)|||units on a scale||Standard Deviation|Mean
797988|NCT00944710|Secondary|Distribution of Randot Preschool Stereoacuity Scores at 12 Weeks for Participants With Anisometropic Amblyopia||12 weeks after randomization|The analysis includes participants with anisometropic amblyopia (no strabismus) who completed the 12-week exam.||participants|||Number
797989|NCT00944710|Secondary|Distribution of Randot Preschool Stereoacuity Score at 12 Weeks|Distribution of Randot Preschool Stereoacuity Score at 12 Weeks; Participants with a Randot Preschool test of >800 seconds of arc were classified as having a stereoacuity of 3000 seconds of arc if the Titmus fly test was positive or as nil if the Titmus fly test was negative.|12 weeks after randomization|The analysis includes all participants who completed the 12-week exam.||participants|||Number
797990|NCT00944710|Secondary|Treatment Group Comparison of the Proportion of Participants Who Have Improved by 2 or More logMAR Visual Acuity Lines Based on Visual Acuity at Best Outcome Visit||10 weeks after randomization or later (until no further VA improvement, up to maximum of 84 weeks for one subject)|||participants|||Number
798065|NCT00945477|Primary|Response Rate at 12 Weeks|Response rate defined as 50% decrease in the Prostate Specific Antigen (PSA) level at week 12 compared to baseline|12 weeks|Five subjects completed the 12 week treatment requirement.||participants|||Number
799114|NCT00951912|Secondary|Total Urinary Isoflavones||3 months|The number of participants for analysis was determinted by the participants who provided the urine samples at the 3-month test.||ug/ml||Standard Deviation|Geometric Mean
797991|NCT00944710|Secondary|Mean Change in Amblyopic-Eye Visual Acuity at Best Outcome Visit|Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. The mean change in amblyopic eye visual acuity since randomization was computed for both treatment groups based on the visit of best post-randomization visual acuity (10 weeks or later) using the initial visual acuity score (if a retest was obtained.)|10 weeks after randomization or later (until no further VA improvement, up to maximum of 84 weeks for one subject)|The analysis includes data from participants who completed the 10-week exam and/or a later visit.||logMAR lines||Standard Deviation|Mean
797992|NCT00944710|Secondary|Distribution of Change in Amblyopic-Eye Visual Acuity From Randomization to Best Outcome Visit|Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. The distribution of change in best post-randomization (10 weeks or later) visual acuity in the amblyopic eye since randomization was tabulated for both treatment groups using the initial visual acuity score (if a retest was obtained.)|Randomization to 10 weeks or later (until no further VA improvement, up to maximum of 84 weeks for one subject)|The analysis includes data from participants who completed the 10-week exam and/or a later visit.||participants|||Number
797993|NCT00944710|Secondary|Mean Amblyopic-Eye Visual Acuity at Best Outcome Visit|Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. A treatment comparison of mean amblyopic eye visual acuity at the visit of best post-randomization visual acuity (10 weeks or later) was performed using an analysis of covariance, adjusting for amblyopic eye visual acuity at randomization.|10 weeks after randomization or later (until no further VA improvement, up to maximum of 84 weeks for one subject)|The analysis includes data from participants who completed the 10-week exam and/or a later visit.||logMAR||Standard Deviation|Mean
797994|NCT00944710|Secondary|Distribution of Amblyopic-Eye Visual Acuity at Best Outcome Visit|Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. The distribution of best post-randomization (10 weeks or later) visual acuity scores in the amblyopic eye was tabulated for both treatment groups using the initial visual acuity score (if a retest was obtained.)|10 weeks after randomization or later (until no further VA improvement, up to maximum of 84 weeks for one subject)|The analysis includes data from participants who completed the 10-week exam and/or a later visit.||participants|||Number
797995|NCT00944710|Secondary|Treatment Comparison of Mean Amblyopic Eye Visual Acuity Change at 10-weeks According to Baseline Characteristics|A treatment comparison of mean amblyopic eye visual acuity change since randomization was performed at the 10-week outcome according to categorical levels of prespecified baseline subgroup factors. The analysis included data from participants with 10-week exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis.|10 weeks after randomization|The analysis included participants who completed 10-week exams between 8 and 15 weeks (inclusive) according to the principles of the primary outcome analysis.||logMAR lines||Standard Deviation|Mean
797996|NCT00944710|Secondary|Mean Amblyopic Eye Visual at Randomization According to Baseline Characteristics for 10-week Outcome|Mean amblyopic eye visual acuity at randomization was computed by treatment group within categorical levels of prespecified baseline subgroup factors. The analysis included data from participants with 10-week exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis.|10 weeks after randomization|The analysis included participants who completed 10-week exams between 8 and 15 weeks (inclusive) according to the principles of the primary outcome analysis.||logMAR||Standard Deviation|Mean
797997|NCT00944710|Secondary|Distribution of Baseline Characteristics at the 10-week Outcome|The number of participants was tabulated by treatment group within categorical levels of prespecified baseline subgroup factors for participants with 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) according to principles specified in the primary outcome analysis.|10 weeks after randomization|The analysis included participants who completed 10-week exams between 8 and 15 weeks (inclusive) according to the principles specified in the primary outcome analysis.||participants|||Number
797998|NCT00944710|Secondary|Mean Change in Fellow-Eye Visual Acuity at 12 Weeks From Randomization||12 weeks after randomization|||change in lines||Standard Deviation|Mean
797999|NCT00944710|Secondary|Distribution of Change in Fellow-Eye Visual Acuity at 12 Weeks From Randomization||12 weeks after randomization|||participants|||Number
798000|NCT00944710|Secondary|Mean Fellow-Eye Visual Acuity at 12-week Exam||12 weeks after randomization|||logMAR||Standard Deviation|Mean
798001|NCT00944710|Secondary|Distribution of 12-week Fellow-Eye Visual Acuity|Following the 10-week primary outcome exam, participants discontinued the randomized treatment and returned 2 weeks later for a 12-week visit to measure off-treatment fellow-eye visual acuity.|12 weeks after randomization|||participants|||Number
798002|NCT00944710|Secondary|Mean Interocular Difference at 12-week Exam|Mean Interocular Difference Between Eyes at 12-week Exam|12 weeks after randomization|||logMAR lines||Standard Deviation|Mean
798003|NCT00944710|Secondary|Distribution of Interocular Difference at 12-week Exam|Distribution of Interocular Difference Between Eyes at 12-week Exam|12 weeks after randomization|||participants|||Number
798004|NCT00944710|Primary|Mean Change in Amblyopic-Eye Visual Acuity at 10 Weeks From Randomization|"The change in 10-week amblyopic eye visual acuity was computed for both treatment groups and included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data.
The primary outcome analysis followed the intent-to-treat principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis."|Randomization to 10 weeks|The primary outcome analysis followed the intent-to-treat principle and included data from 10-week visual acuity exams completed between 8 and 15 weeks (inclusive) with no imputation for missing data.||logMAR lines||Standard Deviation|Mean
798005|NCT00944710|Primary|Distribution of the Change in Amblyopic-Eye Visual Acuity|"The change in 10-week amblyopic eye visual acuity scores since randomization was tabulated for both treatment groups, and included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data.
The primary outcome analysis followed the intent-to-treat principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis."|Randomization to 10 weeks|The primary outcome analysis followed the intent-to-treat principle and included data from 10-week visual acuity exams completed between 8 and 15 weeks (inclusive) with no imputation for missing data.||participants|||Number
798006|NCT00944710|Primary|Mean 10-week Amblyopic-Eye Visual Acuity|"The primary outcome analysis was a treatment group comparison of the masked 10-week amblyopic eye visual acuity using an analysis of covariance (ANCOVA) model, adjusting for visual acuity at randomization. The analysis included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data.
The primary outcome analysis followed the intent-to-treat principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis."|10 weeks after randomization|The primary outcome analysis followed the intent-to-treat principle and included data from 10-week visual acuity exams completed between 8 and 15 weeks (inclusive) with no imputation for missing data.||logMAR||Standard Deviation|Mean
798007|NCT00944710|Secondary|Average Atropine Compliance by Treatment Group|The distribution of compliance with prescribed treatment was tabulated for the 10-week outcome and as averaged scores across all study follow-up visits. Compliance was evaluated as excellent (>75%), good (51%-75%), fair (26%-50%), or poor (<26%) based on discussions with the parent and by reviewing study calendars maintained by the parent, who recorded the frequency of atropine administration.|10 weeks after randomization or later (until no further VA improvement, up to maximum of 84 weeks for one subject)|||participants|||Number
798008|NCT00944710|Secondary|Atropine Compliance at 10 Weeks by Treatment Group|The distribution of compliance with prescribed treatment was tabulated for the 10-week outcome. Compliance was evaluated as excellent (>75%), good (51%-75%), fair (26%-50%), or poor (<26%) based on discussions with the parent and by reviewing study calendars maintained by the parent, who recorded the frequency of atropine administration.|10 weeks after randomization|||participants|||Number
798009|NCT00944710|Secondary|Average Spectacle Compliance by Treatment Group|The distribution of compliance with prescribed treatment was tabulated for the 10-week outcome and as averaged scores across all study follow-up visits. Compliance was evaluated as excellent (>75%), good (51%-75%), fair (26%-50%), or poor (<26%) based on discussions with the parent and by reviewing study calendars maintained by the parent, who recorded the frequency of atropine administration.|10 weeks after randomization or later (until no further VA improvement, up to maximum of 84 weeks for one subject)|||participants|||Number
798010|NCT00944710|Secondary|Spectacle Compliance at 10 Weeks by Treatment Group|The distribution of compliance with prescribed treatment was tabulated for the 10-week outcome. Compliance was evaluated as excellent (>75%), good (51%-75%), fair (26%-50%), or poor (<26%) based on discussions with the parent and by reviewing study calendars maintained by the parent, who recorded the frequency of atropine administration.|10 weeks after randomization|||participants|||Number
798011|NCT00944710|Secondary|Treatment Group Comparison of the Proportion of Participants Who Have Improved by 2 or More logMAR Visual Acuity Lines at 10 Weeks Since Randomization|"The proportion of participants who improved at least 2 logMAR lines since randomization was computed at the 10-week outcome.
The secondary outcome analysis was a treatment group comparison of the proportion of participants whose 10-week masked amblyopic eye visual acuity improved at least 2 logMAR lines since randomization using logistic regression, adjusting for visual acuity at randomization. The analysis included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis."|10 weeks after randomization|The analysis included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis.||participants|||Number
798012|NCT00944710|Secondary|Treatment Group Comparison of the Proportion of Participants Who Achieved 20/25 or Better Visual Acuity at 10 Weeks Since Randomization|"The proportion of participants who achieved 20/25 or better visual acuity since randomization was computed at the 10-week outcome.
The secondary outcome analysis was a treatment group comparison of the proportion of participants whose 10-week masked amblyopic eye visual acuity was 20/25 or better since randomization. The analysis included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis."|10 weeks after randomization|The analysis includes data from participants who completed a 10-week exam.||participants|||Number
798013|NCT00944710|Primary|Distribution of 10-week Amblyopic-Eye Visual Acuity|"The masked 10-week amblyopic eye visual acuity scores were tabulated for both treatment groups, and included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data.
The primary outcome analysis followed the intent-to-treat principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis."|10 weeks after randomization|The primary outcome analysis followed the intent-to-treat principle and included data from 10-week visual acuity exams completed between 8 and 15 weeks (inclusive) with no imputation for missing data.||participants|||Number
798066|NCT00945555|Secondary|Percentage of Participants Who Had a Treatment Modification||Day 4, Day 7 on Average (till the End of Treatment)|All participants enrolled in the study. Number of participants analyzed=number of participants who had a treatment modification at any time point. n=number of participants who had data available at that specific time point.||percentage of participants|||Number
798067|NCT00945555|Secondary|Percentage Survivors||Day 7 on Average (till the End of Treatment)|All participants enrolled in the study. Number of participants analyzed=number of participants with data available.||percentage of participants|||Number
798014|NCT00944749|Primary|Number of Participants With Complete Response at 3 Months.|"The primary endpoint was hematologic response at 3 months, defined as no longer meeting criteria for Severe Aplastic Anemia (SAA).
A complete response was defined as absolute neutrophil count (ANC) above 1.0×109/L, Hgb > 10 g/dL, and platelet count > 100×109/L.
A partial response was defined as a hematologic response that was not sufficient for a complete response.
In subjects with a non-robust hematologic response at 3 months, improvement in one or more of the listed peripheral blood parameter (a,b,c) were recorded as a response: a) ANC - if baseline ANC below 0.5×109/L, increase in ANC by > 0.3×109/L, if baseline ANC above 0.5×109/L, any increase in ANC by > 0.5×109/L of blood; (b) platelets - if baseline platelet count < 50×109/L, any increase in platelet count by > 20×109/L of blood; c) hemoglobin - any increase in hemoglobin by 1.5 g/dl of blood in transfusion-independent patients and in absolute reticulocyte count to > 60×109/L of blood in transfusion-dependent patients."|3 months|||Participants|||Count of Participants
798015|NCT00944749|Primary|Number of Participants With Complete Response at 3 Months.|"The primary endpoint was hematologic response at 3 months, defined as no longer meeting criteria for Severe Aplastic Anemia (SAA) defined as bone marrow cellularity of less than 30% and severe pancytopenia with at least two of the following peripheral blood count criteria: (i) absolute neutrophil count less than 0.5×109/L; (ii) absolute reticulocyte count less than 60×109/L; and (iii) platelet count less than 20×109/L.
A complete response was defined as absolute neutrophil count (ANC) above 1.0×109/L, Hgb > 10 g/dL, and platelet count > 100×109/L.
A partial response was defined as a hematologic response that was not sufficient for a complete response."|3-months|||Participants|||Count of Participants
798016|NCT00945035|Primary|Peak Plasma Concentration (Cmax) for Etoricoxib||Through 120 Hours Postdose|All healthy adult subjects completed the study and were included in the statistical analysis.||ng/mL||Standard Deviation|Least Squares Mean
798017|NCT00945035|Primary|Plasma Area Under the Curve (AUC(0 to Infinity)) for Etoricoxib|The area under the plasma concentration vs time curve.|Through 120 Hours Postdose|All healthy adult subjects completed the study and were included in the statistical analysis.||µg times hr/mL||Standard Deviation|Least Squares Mean
798018|NCT00945100|Secondary|Change in Randot Preschool Stereoacuity Level at 10-week Outcome Since Randomization for Participants With Anisometropic Amblyopia||10 weeks after randomization|Change in stereoacuity level at 10 weeks was computed for participants with anisometropic amblyopia (no strabismus) who had measureable stereoacuity at randomization and at the 10-week primary outcome exam.||participants|||Number
798019|NCT00945100|Secondary|Distribution of Randot Preschool Stereoacuity Scores at 10 Weeks for Participants With Anisometropic Amblyopia||10 weeks after randomization|The analysis includes participants with anisometropic amblyopia (no strabismus) who completed the 10-week exam.||participants|||Number
798020|NCT00945100|Secondary|Distribution of Randot Preschool Stereoacuity Scores at Randomization for Participants With Anisometropic Amblyopia||Randomization|The analysis includes participants with anisometropic amblyopia (no strabismus) who completed the 10-week exam.||participants|||Number
798021|NCT00945100|Secondary|Change in Randot Preschool Stereoacuity Level at 10-week Outcome Since Randomization||10 weeks after randomization|Change in stereoacuity level at 10 weeks was computed for participants with measureable stereoacuity at randomization and at the 10-week primary outcome exam.||participants|||Number
798022|NCT00945100|Secondary|Distribution of Randot Preschool Stereoacuity Scores at 10 Weeks||10 weeks after randomization|The analysis includes all participants who completed the 10-week exam.||participants|||Number
798023|NCT00945100|Secondary|Distribution of Randot Preschool Stereoacuity Scores at Randomization|"The Preschool Randot test measures random dot stereoacuity from 800 to 40 arc seconds (800, 400, 200, 100, 60, 40). Lower scores indicate better stereoacuity and subjects who fail the first level (800 seconds of arc) are assigned a score of >800.
We administer a pretest, and those with a failed or uninterpretable score do not proceed with the Randot testing.
The Preschool Randot test consists of 3 booklets each with 2 sets of 4 random dot shapes (one is blank, 3 are actual figures), which can be matched to non-stereo shapes on the opposite side of the booklets. There are six levels (seconds of arc) in the test with two levels in each book. Each level has 4 rectangles that contain 3 shapes and one blank."|Randomization|The analysis includes all participants who completed the 10-week exam.||participants|||Number
798024|NCT00945100|Secondary|Mean Change in Best Fellow Eye Visual Acuity Since Randomization at Final Visit||10 weeks after randomization or later|||logMAR lines||Standard Deviation|Mean
798025|NCT00945100|Secondary|Distribution of Change in Best Fellow Eye Visual Acuity Since Randomization at Final Visit||10 weeks after randomization or later|The analysis includes data from participants who completed the 10-week exam and/or a later visit.||participants|||Number
798026|NCT00945100|Secondary|Mean Change in Best Fellow Eye Visual Acuity Since Randomization at 10 Weeks||10 weeks after randomization|The analysis includes data from participants who completed a 10-week exam.||logMAR lines||Standard Deviation|Mean
798027|NCT00945100|Secondary|Distribution of Change in Best Fellow Eye Visual Acuity Since Randomization at 10 Weeks||10 weeks after randomization|The analysis includes data from participants who completed a 10-week exam.||participants|||Number
798028|NCT00945100|Secondary|Mean Best Fellow Eye Visual Acuity at Final Visit||10 weeks after randomization or later|The analysis includes data from participants who completed the 10-week exam and/or a later visit.||logMAR||Standard Deviation|Mean
798029|NCT00945100|Secondary|Distribution of Best Fellow Eye Visual Acuity at Final Visit||10 weeks after randomization or later|The analysis includes data from participants who completed the 10-week exam and/or a later visit.||participants|||Number
798030|NCT00945100|Secondary|Mean Best Fellow Eye Visual Acuity at 10-week Outcome||10 weeks after randomization|The analysis includes data from participants who completed a 10-week exam.||logMAR||Standard Deviation|Mean
798031|NCT00945100|Secondary|Distribution of Best Fellow Eye Visual Acuity at 10-week Outcome||10 weeks after randomization|The analysis includes data from participants who completed a 10-week exam.||participants|||Number
798068|NCT00945555|Secondary|Percentage of Participants in Whom New Infection Was Determined at End of Treatment||Day 7 on Average (till the End of Treatment)|All participants enrolled in the study. Number of participants analyzed = number of participants with new infection diagnosed at end of treatment.||percentage of participants|||Number
798069|NCT00945555|Secondary|Percentage of Participants in Whom New Infection Was Determined on Day 4||Day 4|All participants enrolled in the study. Number of participants analyzed=participants with new infection diagnosed on Day 4.||percentage of participants|||Number
798032|NCT00945100|Secondary|Treatment Group Comparison of the Proportion of Participants Who Have Improved by 2 or More logMAR Visual Acuity Lines Based on Visual Acuity at Best Post-randomization Visit|Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. The proportion of participants who improved at least 2 logMAR lines since randomization was computed based on the best post-randomization visual acuity in the amblyopic eye. The initial visual acuity score was used if a retest was obtained.|10 weeks after randomization or later|The analysis includes data from participants who completed the 10-week exam and/or a later visit.||participants|||Number
798033|NCT00945100|Secondary|Mean Change in Amblyopic Eye Visual Acuity Since Randomization at Visit of Best Post-randomization Visual Acuity|Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. The mean change in amblyopic eye visual acuity since randomization was computed for both treatment groups based on the visit of best post-randomization visual acuity (10 weeks or later) using the initial visual acuity score (if a retest was obtained.)|10 weeks after randomization or later|The analysis includes data from participants who completed the 10-week exam and/or a later visit.||logMAR lines||Standard Deviation|Mean
798034|NCT00945100|Secondary|Distribution of the Change in Best Post-randomization Visual Acuity in the Amblyopic Eye|Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. The distribution of change in best post-randomization (10 weeks or later) visual acuity in the amblyopic eye since randomization was tabulated for both treatment groups using the initial visual acuity score (if a retest was obtained.)|Randomization to 10 weeks or later|The analysis includes data from participants who completed the 10-week exam and/or a later visit.||participants|||Number
798035|NCT00945100|Secondary|Mean Amblyopic Eye Visual Acuity at Visit of Best Post-randomization Visual Acuity|Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. A treatment comparison of mean amblyopic eye visual acuity at the visit of best post-randomization visual acuity (10 weeks or later) was performed using an analysis of covariance, adjusting for amblyopic eye visual acuity at randomization.|10 weeks after randomization or later|The primary outcome analysis followed the intent-to-treat principle and included data from 10-week visual acuity exams completed between 8 and 15 weeks (inclusive) with no imputation for missing data.||logMAR||Standard Deviation|Mean
798036|NCT00945100|Secondary|Distribution of Amblyopic Eye Visual Acuity at Visit of Best Post-randomization Visual Acuity|Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. The distribution of best post-randomization (10 weeks or later) visual acuity scores in the amblyopic eye was tabulated for both treatment groups using the initial visual acuity score (if a retest was obtained.)|10 weeks after randomization or later|The analysis includes data from participants who completed the 10-week exam and/or a later visit.||participants|||Number
798037|NCT00945100|Secondary|Treatment Comparison of Mean Amblyopic Eye Visual Acuity Change at 10-weeks According to Baseline Characteristics|A treatment comparison of mean amblyopic eye visual acuity change since randomization was performed at the 10-week outcome according to categorical levels of prespecified baseline subgroup factors. The analysis included data from participants with 10-week exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis.|10 weeks after randomization|The analysis included participants who completed 10-week exams between 8 and 15 weeks (inclusive) according to the principles of the primary outcome analysis.||units on a scale||Standard Deviation|Mean
798038|NCT00945100|Secondary|Mean Amblyopic Eye Visual at Randomization According to Baseline Characteristics for 10-week Outcome|Mean amblyopic eye visual acuity at randomization was computed by treatment group within categorical levels of prespecified baseline subgroup factors. The analysis included data from participants with 10-week exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis.|10 weeks after randomization|The analysis included participants who completed 10-week exams between 8 and 15 weeks (inclusive) according to the principles of the primary outcome analysis.||logMAR||Standard Deviation|Mean
798039|NCT00945100|Primary|Mean Change in Amblyopic Eye Visual Acuity at 10 Weeks From Randomization|"The change in 10-week amblyopic eye visual acuity was computed for both treatment groups and included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data.
The primary outcome analysis followed the intent-to-treat principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis."|Randomization to 10 weeks|The primary outcome analysis followed the intent-to-treat principle and included data from 10-week visual acuity exams completed between 8 and 15 weeks (inclusive) with no imputation for missing data.||logMAR lines||Standard Deviation|Mean
798040|NCT00945100|Primary|Distribution of the Change in Amblyopic Eye Visual Acuity at 10 Weeks From Randomization|"The change in 10-week amblyopic eye visual acuity scores since randomization was tabulated for both treatment groups, and included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data.
The primary outcome analysis followed the intent-to-treat principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis."|Randomization to 10 weeks|The primary outcome analysis followed the intent-to-treat principle and included data from 10-week visual acuity exams completed between 8 and 15 weeks (inclusive) with no imputation for missing data.||participants|||Number
799115|NCT00951912|Primary|Percentage Change in Low Density Lipoprotein Cholesterol|(6th month value-baseline value)/baseline value*100%|Baseline, 6 months|The number of participants for analysis was determinted by intention to treat||Percentage of change||Standard Deviation|Mean
798041|NCT00945100|Primary|Mean 10-week Amblyopic Eye Visual Acuity|"The primary outcome analysis was a treatment group comparison of the masked 10-week amblyopic eye visual acuity using an analysis of covariance (ANCOVA) model, adjusting for visual acuity at randomization. The analysis included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data.
The primary outcome analysis followed the intent-to-treat principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis."|10 weeks after randomization|The primary outcome analysis followed the intent-to-treat principle and included data from 10-week visual acuity exams completed between 8 and 15 weeks (inclusive) with no imputation for missing data.||logMAR||Standard Deviation|Mean
798042|NCT00945100|Secondary|Distribution of Baseline Characteristics at the 10-week Outcome|The number of participants was tabulated by treatment group within categorical levels of prespecified baseline subgroup factors for participants with 10-week visual acuity exams completed between 8 to 15 weeks (inclusive)according to principles specified in the primary outcome analysis.|10 weeks after randomization|The analysis included participants who completed 10-week exams between 8 and 15 weeks (inclusive) according to the principles specified in the primary outcome analysis.||participants|||Number
798043|NCT00945100|Secondary|Treatment Group Comparison of 10-week Interocular Difference|The secondary outcome analysis was a treatment group comparison of the 10-week interocular difference (IOD), computed as the difference between the masked amblyopic and fellow eye visual acuities, using an analysis of covariance (ANCOVA) model, adjusting for IOD at randomization. The analysis included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis.|10 weeks after randomization|The analysis included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis.||logMAR lines||Standard Deviation|Mean
798044|NCT00945100|Secondary|Treatment Group Comparison of the Proportion of Participants Who Have Improved by 2 or More logMAR Visual Acuity Lines at 10 Weeks Since Randomization|"The proportion of participants who improved at least 2 logMAR lines since randomization was computed at the 10-week outcome.
The secondary outcome analysis was a treatment group comparison of the proportion of participants whose 10-week masked amblyopic eye visual acuity improved at least 2 logMAR lines since randomization using logistic regression, adjusting for visual acuity at randomization. The analysis included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis."|10 weeks after randomization|The analysis included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis.||participants|||Number
798045|NCT00945100|Secondary|Average Compliance With Prescribed Patching by Treatment Group|The distribution of compliance with prescribed treatment was tabulated for the 10-week outcome and as averaged scores across all study follow-up visits. Compliance was evaluated as excellent (>75%), good (51%-75%), fair (26%-50%), or poor (<26%) based on discussions with the parent and by reviewing study calendars maintained by the parent, who recorded the number of hours the child patched each day.|10 weeks after randomization or later|||participants|||Number
798046|NCT00945100|Secondary|Compliance With Prescribed Patching by Treatment Group at 10 Weeks|The distribution of compliance with prescribed treatment was tabulated for the 10-week outcome and as averaged scores across all study follow-up visits. Compliance was evaluated as excellent (>75%), good (51%-75%), fair (26%-50%), or poor (<26%) based on discussions with the parent and by reviewing study calendars maintained by the parent, who recorded the number of hours the child patched each day.|10 weeks after randomization|||participants|||Number
798047|NCT00945100|Primary|Distribution of 10-week Amblyopic Eye Visual Acuity|"The masked 10-week amblyopic eye visual acuity scores were tabulated for both treatment groups, and included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data.
The primary outcome analysis followed the intent-to-treat principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis."|10 weeks after randomization|The primary outcome analysis followed the intent-to-treat principle and included data from 10-week visual acuity exams completed between 8 and 15 weeks (inclusive) with no imputation for missing data.||participants|||Number
798048|NCT00945139|Primary|Progression Free Survival (PFS) by GCIC Criteria|Using GCIC criteria, progression is defined as CA-125 levels greater than, or equal to, 2 times the upper limit of a reference range on 2 occasions and at least 1 week apart.|Up to 25 months|28 out of 46 enrolled patients were assessable for PFS per GCIC criteria. The remaining patients could not be evaluated for this endpoint because the timing of their CA-125 measurements did not meet the defined criteria.||Months||95% Confidence Interval|Median
798049|NCT00945139|Secondary|Overall Response Rate (ORR) by GCIC Criteria|A response according to GCIC criteria has occurred if there is at least a 50% reduction in CA 125 levels from a pretreatment sample. The response must be confirmed and maintained for at least 28 days. Patients can be evaluated according to CA-125 only if they have a pretreatment sample that is at least twice the upper limit of normal and within 2 weeks prior to starting treatment.|3 years|43 out of 46 enrolled patients were assessable for PFS by RECIST criteria. The remaining patients could not be evaluated for this endpoint because of missed imaging scans that prevented analysis according to the defined criteria.||percentage of participants||95% Confidence Interval|Number
798070|NCT00945555|Secondary|Mean Neutrophil Count||Baseline, Day 4, Day 7 on Average (till the End of Treatment)|All participants enrolled in the study. Number of participants analyzed=number of participants with available data. n=number of participants with data available at that time point.||neutrophils per cubic millimeter||Standard Deviation|Mean
798071|NCT00945555|Secondary|Mean Body Temperature||Baseline, Day 4, Day 7 on Average (till the End of Treatment)|All participants enrolled in the study. n=number of participants with available data at that time point.||Degree Celsius||Standard Deviation|Mean
799116|NCT00951912|Primary|Percentage Change in High Density Lipoprotein Cholesterol|(6th month value-baseline value)/baseline value*100%|Baseline, 6 months|||Percentage of change||Standard Deviation|Mean
798050|NCT00945139|Secondary|Clinical Benefit Rate (by RECIST)|Clinical Benefit Rate (CBR) is the sum of the percentages of patients achieving complete response, partial response, and stable disease. Tumor response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by physical exam and/or computerized tomography (CT): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|3 years|43 out of 46 enrolled patients were assessable for PFS by RECIST criteria. The remaining patients could not be evaluated for this endpoint because of missed imaging scans that prevented analysis according to the defined criteria.||percentage of participants||95% Confidence Interval|Number
798051|NCT00945139|Secondary|Overall Response Rate (ORR) by RECIST|ORR is the sum of the percentages of patients achieving complete and partial responses. Tumor response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0)|3 years|43 out of 46 enrolled patients were assessable for PFS by RECIST criteria. The remaining patients could not be evaluated for this endpoint because of missed imaging scans that prevented analysis according to the defined criteria.||Percentage of participants||95% Confidence Interval|Number
798052|NCT00945139|Secondary|Overall Survival|The time from treatment initiation to death by any cause|4 years|||Months||Full Range|Median
798053|NCT00945139|Primary|Progression Free Survival (PFS) by RECIST Criteria|Tumor response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by hysical exam and/or computerized tomography (CT): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Up to 25 months|43 out of 46 enrolled patients were assessable for PFS by RECIST criteria. The remaining patients could not be evaluated for this endpoint because of missed imaging scans that prevented analysis according to the defined criteria.||Months||Full Range|Median
798054|NCT00945243|Secondary|Implant Related Complications|Percentage of subjects who had an implant related complication|24 months|11 subjects were enrolled and treated on protocol and were thus considered for safety information||percentage of subjects|||Number
798055|NCT00945243|Secondary|Improvement in the Neck and Arm Visual Analog Pain Scale (VAS)|Percentage of subjects who experienced a maintenance of improvement in VAS neck pain intensity, neck pain frequency, arm pain intensity, and/or arm pain frequency.|24 months|8 subjects had data at 24 months.||percentage of subjects|||Number
798056|NCT00945243|Primary|Assessment of Neck Disability Index Scores|Percentage of subjects who experienced a maintenance or improvement according to measures of pain and/or function.|24 months|8 subjects had data at 24 months||percentage of subjects|||Number
798057|NCT00945256|Primary|Mixed Muscle Fractional Synthesis Rate (FSR)|The rate at which the body makes new muscle was assessed by determining the fractional synthesis rate (FSR). This technique determines how quickly new amino acids are used to make muscle. In this technique, a special (but natural and non-radioactive) version of an amino acid is infused into the blood. This special version of the amino acid is heavier than the most common version the same amino acid. This property allows it to be identified in a muscle sample. By determining how much of the special amino acid has accumulated over time in a muscle sample, the fractional synthesis rate can be determined. For example, if the rate were such that 1 of every 100 amino acids were of the special type after 1 day, the fractional synthesis rate would be 1% per day. In other words, 1/100 of the muscle would be newly made each day.|Acute ( 8 hours)|FSR was not calculated for the Elderly Sodium Nitroprusside with Amino Acid Drink arm of the study.||Fractional Synthesis Rate (pecent/hour)||Standard Error|Mean
798058|NCT00945295|Secondary|Length of Time to Meet Re-injection Criteria and the Number of Participants That do Not Meet Re-injection Criteria Prior to Completion of the Study.||6 Weeks|||number|||Number
798059|NCT00945295|Primary|The Maximum Change in Fugl-Meyer Upper Extremity Score From the Baseline Exam to Any Post Injection Visit in Each Treatment Arm. Comparison of the Difference Scores Between the Two Groups Will be Considered Significant at p < 0.05.||6 Weeks|||difference|||Number
798060|NCT00945321|Primary|Peak Plasma Concentration (Cmax) Following Single Dose Administration of Aprepitant 165 mg or 185 mg and Fosaprepitant 150 mg.||Through 72 Hours Postdose|All subjects excluding one subject who dropped from the study after Period 1 due to accidental overdose were included in the pharmacokinetic (PK) analysis.||ng/mL||Standard Error|Mean
798061|NCT00945321|Primary|Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of Aprepitant 165 mg or 185 mg and Fosaprepitant 150 mg||Through 72 Hours Postdose|All subjects excluding one subject who dropped from the study after Period 1 due to accidental overdose were included in the pharmacokinetic (PK) analysis.||ng•hr/mL||Standard Deviation|Mean
798062|NCT00945334|Secondary|Change in Methane From Baseline|"Methane output was reported as methane in parts per million (ppm) on breath test:
Subjects fast for 12 h prior to a breath sample. Breath samples were collected via a Quintron dual bag collecting system and analyzed using a BreathTracker SC. Output was reported as methane in parts per million (ppm) after correction for alveolar sample quality using breath CO2 concentration."|Baseline (Day 0) and Final Visit (Day 44)|Change in breath test methane gas levels: baseline breath test minus final breath test measurement.||parts per million||Standard Deviation|Median
798063|NCT00945334|Primary|Severity of Constipation in Each Arm at Week 1 After Completion of Therapy|"Visual analog scale (VAS) score for constipation:
Severity was rated using a VAS from 0 to 100 units (with 0 = no symptom and 100 = severe symptoms)."|1 year|||units on a scale||Standard Deviation|Mean
798064|NCT00945477|Secondary|Number Adverse Events, Grades 1-5 Using NCI-CTCAE v 3.0|Safety was evaluated by documentation of Adverse Events (AEs), by assessment of clinical laboratory findings, and by physicial examination, including measurement of vital signs and weight in all eleven subjects.|0-12 weeks|The adverse events for all participants enrolled were evaluated by documentation of Adverse Events (AEs)Grades 1-5 using NCI-CTCAE v 3.0||Adverse events Grade 1-5|||Number
798072|NCT00945555|Primary|Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted||Baseline|All participants enrolled in the study who received treatment for febrile neutropenia. Number of participants analyzed=number of participants who received an antibacterial drug for the treatment of febrile neutropenia. Participants may be counted more than once because they may have received more than one antibacterial agent.||percentage of participants|||Number
798073|NCT00945555|Primary|Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring Febrile Neutropenia (FEN) in Their Therapeutical Approach: Empirical||Baseline|All participants enrolled in the study. Participants may be counted more than once because they may have received more than one antibacterial agent.||percentage of participants|||Number
798074|NCT00945750|Secondary|Cmax of Famotidine Following Single Dose Administration of Famotidine CT With Water and Famotidine FCT With Water|Cmax values were natural log-transformed and analyzed using an ANOVA model. The ANOVA model contained factors for participant (random effect), period, treatment, and within-participant error.|0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose|Participants who completed the study||ng/mL||95% Confidence Interval|Geometric Mean
798075|NCT00945750|Secondary|AUC 0-∞ Following Single Dose Administration of Famotidine CT With Water and Famotidine FCT With Water|AUC values were natural log-transformed and analyzed using an ANOVA model. The ANOVA model contained factors for participant (random effect), period, treatment, and within-participant error.|0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose|Participants who completed the study||ng/mL hr||95% Confidence Interval|Geometric Mean
798076|NCT00945750|Primary|Peak Plasma Concentration (Cmax) of Famotidine Following Single Dose Administration of Famotidine CT Without Water and Famotidine FCT With Water|Cmax values were natural log-transformed and analyzed using an ANOVA model. The ANOVA model contained factors for participant (random effect), period, treatment, and within-participant error.|0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose|Participants who completed the study||ng/mL||95% Confidence Interval|Geometric Mean
798077|NCT00945750|Primary|Area Under the Concentration-time Curve From 0 to Infinity (AUC 0-∞) Following Single Dose Administration of Famotidine CT Without Water and Famotidine FCT With Water|AUC values were natural log-transformed and analyzed using an analysis of variance (ANOVA) model. The ANOVA model contained factors for participant (random effect), period, treatment, and within-participant error.|0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose|Participants who completed the study||ng/mL hr||95% Confidence Interval|Geometric Mean
798078|NCT00945815|Primary|Complete Remission|Complete remission (CR) is defined as: <5% marrow aspirate blasts. Blasts can be >=5% if the blasts are found to be myeloid and there is no evidence of lymphoblasts by flow cytometry or immunostaining. Neutrophils >= 1000/mcl; platelets >100,000/mcl; and no blasts in the peripheral blood. C1 Extramedullary disease status as defined in the protocol. Complete remission with incomplete platelet recovery (CRi) is same as CR but platelet count may be <=100,000/mcl and/or ANC may be <1,000/mcl.|After induction therapy was completed (1 or 2 months)|Eligible patients who began protocol therapy.||percentage of participants||95% Confidence Interval|Number
798079|NCT00945815|Secondary|Number of Patients With Grade 3 Through 5 Treatment-Related Adverse Events|Only adverse events that are possibly, probably or definitely related to study drug are reported. Any CTCAE 4.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.|Up to 5 years|Eligible patients who received any treatment and were assessed for toxicity were included in the adverse event summaries.||Participants|||Number
798080|NCT00945854|Secondary|Postprandial Plasma Lipid Changes|Blood samples during the standard meal test were drawn from an antecubital vein after a 12 h overnight fast and 0, 30, 60, 90, 120, 150 and 180 min postprandial for the measurement of triglyceride response reported as average mean postprandial increment.|12 weeks|||mg/dlx3hrs||Standard Deviation|Mean
798081|NCT00945854|Secondary|Postprandial Insulin Changes|Blood samples during the standard meal test were drawn from an antecubital vein after a 12 h overnight fast and 0, 30, 60, 90, 120, 150 and 180 min postprandial for the measurement of plasma insulin response reported as average mean postprandial increment.|12 weeks|||(microU/mlx3hrs)||Standard Deviation|Mean
798082|NCT00945854|Primary|Insulin Sensitivity (Si)|Peripheral insulin sensitivity was assessed by FSIGT. A glucose dose of 300 mg/kg body weight was given intravenously followed by a bolus of 0.03 U/kg of insulin injected after 20 min. Blood samples were frequently collected for 3 h for the measurement of plasma glucose and serum insulin concentrations, utilized to calculate the insulin sensitivity index Si|12 weeks|||104xmin-1/microU/ml||Standard Error|Mean
798083|NCT00945893|Secondary|Serum HAI GMTs in All Participants Regardless of Baseline Serostatus, Dose 2 (Day 29)|All immunogenicity analyses are based on the immunogenicity population.|Day 1, Day 57|Participants who received 2 doses of the same investigational product and had valid HAI measurements from blood samples obtained at baseline and post Dose 2 were included in the analysis.||Titer||Full Range|Geometric Mean
798084|NCT00945893|Secondary|Serum HAI GMTs in All Participants Regardless of Baseline Serostatus, Dose 1 (Day 29)|All immunogenicity analyses are based on the immunogenicity population.|Day 1, Day 29|Participants were randomized at a 1:1 ratio to have their post Dose 1 immunogenicity blood draw on either Day 15 or Day 29. Participants who received Dose 1 of the investigational product and had valid HAI measurements from blood samples obtained at baseline and post Dose 1 were included in the analysis.||Titer||Full Range|Geometric Mean
798085|NCT00945893|Secondary|Serum HAI Geometric Mean Titers (GMTs) in All Participants Regardless of Baseline Serostatus, Dose 1 (Day 15)|All immunogenicity analyses are based on the immunogenicity population.|Day 1, Day 15|Participants were randomized at a 1:1 ratio to have their post Dose 1 immunogenicity blood draw on either Day 15 or Day 29. Participants who received Dose 1 of the investigational product and had valid HAI measurements from blood samples obtained at baseline and post Dose 1 were included in the analysis.||Titer||Full Range|Geometric Mean
798086|NCT00945893|Secondary|Number of Participants Who Achieved a Post Dose 2 (Day 57) HAI Titer ≥ 32 Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus|All immunogenicity analyses are based on the immunogenicity population.|Day 1, Day 57|Participants who received 2 doses of the same investigational product and had valid HAI measurements from blood samples obtained at baseline and post Dose 2 were included in the analysis.||Participants|||Number
811704|NCT01059760|Primary|Change From Baseline in Participant Mean Platelet Volume (MPV) When Fasting and Fed||Baseline and 3 days|||fL||Standard Deviation|Mean
798087|NCT00945893|Secondary|Number of Participants Who Achieved a Post Dose 1 (Day 29) HAI Titer ≥ 32 Against the H1N1 Strain in All Subjects Regardless of Baseline Serostatus|All immunogenicity analyses are based on the immunogenicity population.|Day 1, Day 29|Participants were randomized at a 1:1 ratio to have their post Dose 1 immunogenicity blood draw on either Day 15 or Day 29. Participants who received Dose 1 of the investigational product and had valid HAI measurements from blood samples obtained at baseline and post Dose 1 were included in the analysis.||Participants|||Number
798088|NCT00945893|Secondary|Number of Participants Who Achieved a Post Dose 1 (Day 15) HAI Titer ≥ 32 Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus|All immunogenicity analyses are based on the immunogenicity population.|Day 1, Day 15|Participants were randomized at a 1:1 ratio to have their post Dose 1 immunogenicity blood draw on either Day 15 or Day 29. Participants who received Dose 1 of the investigational product and had valid HAI measurements from blood samples obtained at baseline and post Dose 1 were included in the analysis.||Participants|||Number
798089|NCT00945893|Secondary|Number of Participants With NOCDs Through 180 Days Post Final Dose.|An NOCD was a newly diagnosed medical condition that was of a chronic, ongoing nature and was assessed by the investigator as medically significant. Examples of NOCDs included, but were not limited to, diabetes, asthma, autoimmune disease (eg, lupus, rheumatoid arthritis), and neurological disease (eg, epilepsy, autism). Examples of events not considered NOCDs were mild eczema, diagnosis of a congenital anomaly present at study entry, or acute illness (eg, otitis media, bronchitis).|Days 1-209|The Safety Population was defined as all participants who received at least one dose of investigational product and had any follow-up for safety.||Participants|||Number
798090|NCT00945893|Secondary|Number of Participants With SAEs Through 180 Days Post Final Dose|SAEs were those AEs that resulted in death; were immediately life threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a birth defect in the offspring of a participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed above.|Days 1-209|The Safety Population was defined as all participants who received at least one dose of investigational product and had any follow-up for safety.||Participants|||Number
798091|NCT00945893|Secondary|Number of Participants With NOCDs Within 28 Days Post Vaccination, Dose 2|An NOCD was a newly diagnosed medical condition that was of a chronic, ongoing nature and was assessed by the investigator as medically significant. Examples of NOCDs included, but were not limited to, diabetes, asthma, autoimmune disease (eg, lupus, rheumatoid arthritis), and neurological disease (eg, epilepsy, autism). Examples of events not considered NOCDs were mild eczema, diagnosis of a congenital anomaly present at study entry, or acute illness (eg, otitis media, bronchitis).|Days 29-57|Participants in the Safety Population for Dose 2 who received Dose 2 and had any safety follow-up during the reporting period.||Participants|||Number
798092|NCT00945893|Secondary|Number of Participants With SAEs Through 28 Days Post Vaccination, Dose 2|SAEs were those AEs that resulted in death; were immediately life threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a birth defect in the offspring of a participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed above.|Days 29-57|Participants in the Safety Population for Dose 2 who received Dose 2 and had any follow-up for safety during the reporting period.||Participants|||Number
798093|NCT00945893|Secondary|Number of Participants With New Onset Chronic Diseases (NOCDs) Within 28 Days Post Vaccination, Dose 1|An NOCD was a newly diagnosed medical condition that was of a chronic, ongoing nature and was assessed by the investigator as medically significant. Examples of NOCDs included, but were not limited to, diabetes, asthma, autoimmune disease (eg, lupus, rheumatoid arthritis), and neurological disease (eg, epilepsy, autism). Examples of events not considered NOCDs were mild eczema, diagnosis of a congenital anomaly present at study entry, or acute illness (eg, otitis media, bronchitis).|Days 1-29|The Safety Population was defined as all participants who received at least one dose of investigational product and had any follow-up for safety.||Participants|||Number
798094|NCT00945893|Secondary|Number of Participants With Serious Adverse Events (SAEs) Through 28 Days Post Vaccination, Dose 1|SAEs were those AEs that resulted in death; were immediately life threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a birth defect in the offspring of a participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed above.|Days 1-29|The Safety Population was defined as all participants who received at least one dose of investigational product and had any follow-up for safety.||Participants|||Number
798095|NCT00945893|Secondary|Number of Participants Using Anti-pyretic and Analgesic Agents Within 14 Days Post Vaccination, Dose 2||Days 29-43|Participants in the Safety Population who received Dose 2 and had any follow-up for safety during the reporting period.||Participants|||Number
798096|NCT00945893|Secondary|Number of Participants Reporting AEs Within 14 Days Post Vaccination, Dose 2||Days 29-43|Participants in the Safety Population who received Dose 2 and had any follow-up for safety during the reporting period.||Participants|||Number
798097|NCT00945893|Secondary|Number of Participants With Any Solicited Symptom Within 14 Days Post Vaccination, Dose 2||Days 29-43|Participants in the Safety Population who received Dose 2 and had solicited symptom data available during the reporting period.||Participants|||Number
798098|NCT00945893|Secondary|Number of Participants Using Anti-pyretic and Analgesic Agents Within 7 Days Post Vaccination, Dose 2||Days 29-36|Participants in the safety population who received Dose 2 and had any follow-up for safety during the reporting period.||Participants|||Number
798099|NCT00945893|Secondary|Number of Participants Reporting AEs Within 7 Days Post Vaccination, Dose 2||Days 29-36|Participants in the Safety Population who received Dose 2 and had any follow-up for safety during the reporting period.||Participants|||Number
800797|NCT00960375|Primary|Number of Cigarettes Smoked Per Day|Number of cigarettes smoked per day for the last 7 days|day|All randomized||number of cigarettes||Standard Deviation|Mean
798104|NCT00945893|Secondary|Number of Participants Using Anti-pyretic and Analgesic Agents Within 7 Days Post Vaccination, Dose 1.||Days 1-8|The Safety population was defined as all participants who received at least one dose of investigational product and had any follow-up for safety.||Participants|||Number
798105|NCT00945893|Secondary|Number of Participants Reporting Adverse Events (AEs) Within 7 Days Post Vaccination, Dose 1||Days 1-8|The Safety Population was defined as all participants who received at least one dose of investigational product and had any follow-up for safety.||Participants|||Number
798106|NCT00945893|Secondary|Number of Participants With Any Solicited Symptom Within 7 Days Post Vaccination, Dose 1|Solicited symptoms were events considered likely to occur post dosing. For this study, other solicited symptoms included: Fever (> 100°F [37.8°C] oral), Runny nose, Sore throat, Cough, Vomiting, Muscle aches, Chills, Decreased activity (tiredness), and Headache.|Days 1-8|The Safety population for solicited symptoms was defined as all participants who received at least one dose of investigational product, had any follow-up for safety and had solicited symptom data available during the reporting period.||Participants|||Number
798107|NCT00945893|Primary|Number of Participants Who Experienced a Post Dose 2 (Day 57) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. All immunogenicity analyses were based on the immunogenicity population.|Day 1, Day 57|Participants who received 2 doses of the same investigational product and had valid HAI measurements from blood samples obtained at baseline and post Dose 2 were included in the analysis.||Participants|||Number
798108|NCT00945893|Primary|Number of Participants Who Experienced a Post Dose 1 (Day 29) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. All immunogenicity analyses were based on the immunogenicity population.|Day 1, Day 29|For each treatment group, participants were randomized at a 1:1 ratio to have their post Dose 1 immunogenicity blood draw occur on either Day 15 or Day 29. Participants who received Dose 1 of the investigational product and had valid HAI measurements from blood samples obtained at baseline and post Dose 1 were included in the analysis.||Participants|||Number
798109|NCT00945893|Primary|Number of Participants Who Experienced a Post Dose 1 (Day 15) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus|Seroresponse was defined as a ≥ 4-fold rise in hemagglutination inhibition (HAI) titer from baseline. All immunogenicity analyses were based on the immunogenicity population.|Day 1, Day 15|For each treatment group, participants were randomized at a 1:1 ratio to have their post Dose 1 immunogenicity blood draw occur on either Day 15 or Day 29. Participants who received Dose 1 of the investigational product and had valid HAI measurements from blood samples obtained at baseline and post Dose 1 were included in the analysis.||Participants|||Number
798110|NCT00945893|Primary|Number of Participants With Fever Post Dose 1 (Days 1-8), Defined as an Oral Temperature ≥ 101°F (38.3°C).|The number of participants with fever between the two treatment groups was compared based on the upper limit of the two-sided 95% exact confidence intervals (CIs) for the rate difference (Vaccine minus Placebo). The upper limit of the two-sided 95% CI was evaluated against the prespecified equivalence criterion of 10% which corresponded to the following hypotheses • H0 (null): rate difference ≥ 10% • HA (alternative): rate difference < 10%|Days 1-8|Safety Population was defined as all participants who received at least one dose of investigational product and had any follow-up for safety.||Participants|||Number
798111|NCT00945906|Secondary|Number of Bleeding Episodes|Number of bleeding episodes at any time after the first infusion in the study.|After the first infusion until study completion. Study completion is up to 2 years or until Factor XIII Concentrate (Human) is commercially available in the USA.|The Safety Population consisted of all subjects who received a dose of Factor XIII Concentrate (Human) during the study.||Episodes|||Number
798112|NCT00945906|Secondary|Number of Subjects With at Least One Bleeding Episode|Number of subjects with at least one bleeding episode at any time after the first infusion in the study, and the number of subjects with at least one bleeding episode requiring Factor XIII treatment.|After the first infusion until study completion. Study completion is up to 2 years or until Factor XIII Concentrate (Human) is commercially available in the USA.|The Safety Population consisted of all subjects who received a dose of Factor XIII Concentrate (Human) during the study.||participants|||Number
798113|NCT00945906|Secondary|FXIII Concentration|Trough Factor XIII concentration.|Before the first infusion, at 24 and 48 weeks after the first infusion, and at the end-of-study (or withdrawal) visit.|The Safety Population consisted of all subjects who received a dose of Factor XIII Concentrate (Human) during the study.||Units/mL||Standard Deviation|Mean
798114|NCT00945906|Secondary|FXIII Antibody Testing|Number of participants with serum Factor XIII antibodies.|Before the first infusion, then every 48 weeks, at the end-of-study (or withdrawal) visit and after a bleeding episode requiring treatment with a Factor XIII -containing product.|The Safety Population consisted of all subjects who received a dose of Factor XIII Concentrate (Human) during the study.||participants|||Number
798115|NCT00945906|Secondary|Hematology and Chemistry Testing|Number of participants with treatment-emergent clinically significant hematology and/or chemistry laboratory parameter values.|After the first infusion and at the end-of-study (or withdrawal) visit.|The Safety Population consisted of all subjects who received a dose of Factor XIII Concentrate (Human) during the study.||participants|||Number
798116|NCT00945906|Primary|Adverse Events|Number of subjects with any treatment-emergent adverse event (AE), treatment-related AE or serious AE (SAE). Treatment-related AEs are defined as AEs whose relationship to treatment is related, or possibly related and AEs with missing relationship.|After the first infusion until study completion. Study completion is up to 2 years or until Factor XIII Concentrate (Human) is commercially available in the USA.|The Safety Population consisted of all subjects who received a dose of Factor XIII Concentrate (Human) during the study. Treatment related AEs are events whose relationship to study treatment is related, or possibly related, in the opinion of the investigator. AEs with missing relationship are considered related to treatment.||participants|||Number
798159|NCT00946101|Secondary|Number of Participants With Any Solicited Symptoms Within 14 Days After Vaccination With Investigational Product, Dose 1||Days 1-15|The safety population included all participants who received at least one dose of investigational product (H1N1=259; Placebo=65), experienced any follow-up for safety, and had solicited symptoms data available during the reporting period (H1N1=259; Placebo=65).||participants|||Number
798117|NCT00945945|Secondary|Mean Change From Baseline to Endpoint (13 Week) in 36-item Short-Form Health Survey|Self-reported questionnaire with 36 questions covering 8 health domains. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. Due to the nature of a study drug labeling error and the resultant treatment crossover (see Arms), the data from both protocol-defined treatment groups were compromised, and the intended comparisons for differences between those treatment groups are considered unevaluable. Secondary efficacy results from the 2 mixed-treatment groups are not presented.|Baseline, 13 weeks|||units on a scale||Standard Deviation|Mean
798118|NCT00945945|Secondary|Mean Change of Total Score From Baseline to Endpoint (13 Week) in European Quality of Life Questionnaire (EQ-5D)|Patients rate their health state in 5 domains: mobility, self-care, usual activities, pain, and mood. Score between 1-3 is generated for each domain which is mapped to single index score. Index ranges between 0-1; higher scores indicate better health perceived by patient. Due to nature of study drug labeling error and resultant treatment crossover, data from both protocol-defined treatment groups were compromised, and intended comparisons for differences between those treatment groups are considered unevaluable. Secondary efficacy results from the 2 mixed-treatment groups are not presented.|Baseline, 13 weeks|||units on a scale||Standard Deviation|Mean
798119|NCT00945945|Secondary|Mean Change of Total Score From Baseline to Endpoint (13 Week) in Profile of Mood States- Brief Form (BPOMS)|BPOMS measures mood states and has 6 factors: tension-anxiety, depression-dejection, anxiety-hostility, fatigue, confusion, and vigor. Item scores: 0 (not at all) to 4 (extremely). Each factor scores range from 0-20. Total score = sum of all factor scores minus vigor score. Due to nature of study drug labeling error and resultant treatment crossover, data from both protocol-defined treatment groups were compromised, and intended comparisons for differences between those treatment groups are considered unevaluable. Secondary efficacy results from the 2 mixed-treatment groups are not presented.|Baseline, 13 weeks|||units on a scale||Standard Deviation|Mean
798120|NCT00945945|Secondary|Mean Change of Total Score From Baseline to Endpoint(13 Week) in Intermittent and Constant Osteoarthritis Pain: Knee Version|An 11-item questionnaire to individually and jointly assess intermittent and constant pain. Questions assess intensity and impact of pain on activity and emotion. Each item is scored from 0 to 4; higher values indicate higher severity. Total Pain score ranges from 0-44. Due to the nature of study drug labeling error and resultant treatment crossover, data from both protocol-defined treatment groups were compromised, and intended comparisons for differences between those treatment groups are considered unevaluable. Secondary efficacy results from the 2 mixed-treatment groups are not presented.|Baseline, 13 weeks|||units on a scale||Standard Deviation|Mean
798121|NCT00945945|Secondary|Mean Change of Total Score From Baseline to Endpoint (13 Week) in Clinical Global Impressions of Severity (CGI-S)|Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Due to the nature of a study drug labeling error and the resultant treatment crossover (see Arms), the data from both protocol-defined treatment groups were compromised, and the intended comparisons for differences between those treatment groups are considered unevaluable. Secondary efficacy results from the 2 mixed-treatment groups are not presented.|Baseline, 13 weeks|||units on a scale||Standard Deviation|Mean
798122|NCT00945945|Secondary|Mean Change of Total Score From Baseline to Endpoint (13 Week) in Brief Pain Inventory- Interference Score|Interference scores range from 0 (does not interfere) to 10 (completely interferes) on 7 questions assessing interference of pain for general activity, mood, walking ability, normal work, relations with others, sleep, and enjoyment of life. Total score ranges from 0-70. Due to the nature of study drug labeling error and resultant treatment crossover, data from both protocol-defined treatment groups were compromised, and intended comparisons for differences between those treatment groups are considered unevaluable. Secondary efficacy results from the 2 mixed-treatment groups are not presented.|Baseline, 13 weeks|||units on a scale||Standard Deviation|Mean
798123|NCT00945945|Secondary|Mean Change of Total Score From Baseline to Endpoint (13 Week) of Brief Pain Inventory-Severity (BPI-S) Scale|Self-reported scale measuring pain severity. Severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Four questions assess worst pain, least pain, and average pain in the past 24 hours, and pain right now. Total score ranges from 0-40. Due to the nature of a study drug labeling error and resultant treatment crossover, data from both protocol-defined treatment groups were compromised, and the intended comparisons for differences between those treatment groups are considered unevaluable. Secondary efficacy results from the 2 mixed-treatment groups are not presented.|Baseline, 13 weeks|||units on a scale||Standard Deviation|Mean
798124|NCT00945945|Secondary|Mean Change From Baseline to Endpoint (13 Week) in Western Ontario McMaster Universities (WOMAC) Index Score|The WOMAC index (pain, stiffness, physical function subscales) was completed by the patient. The index has 24 questions. Each question is answered using a 5-point Likert scale (0 to 4). The Total score has a range from 0 (none) to 96 (extreme). Due to the nature of a study drug labeling error and the resultant treatment crossover (see Arms), data from both protocol-defined treatment groups were compromised, and the intended comparisons for differences between those treatment groups are considered unevaluable. Secondary efficacy results from the 2 mixed-treatment groups are not presented.|baseline, 13 weeks|||units on a scale||Standard Deviation|Mean
798125|NCT00945945|Secondary|Mean Change From Baseline to Endpoint (13 Week) in Patient's Global Impressions of Improvement Score|A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). Due to the nature of a study drug labeling error and the resultant treatment crossover (see Arms), the data from both protocol-defined treatment groups were compromised, and the intended comparisons for differences between those treatment groups are considered unevaluable. Secondary efficacy results from the 2 mixed-treatment groups are not presented.|Baseline, 13 weeks|||participants||Standard Deviation|Mean
798126|NCT00945945|Secondary|Number of Participants With Suicidal Behaviors and Ideations From the Columbia Suicide Severity Rating Scale|C-SSRS: scale capturing occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of patients with suicidal behaviors and ideations are provided. Suicidal behavior: a “yes” answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a “yes” answer to any one of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation.|Baseline through 13 weeks|All randomized participants.||participants|||Number
798127|NCT00945945|Primary|"Change From Baseline to 13 Week Endpoint (Baseline Observation Carried Forward [BOCF]) in Brief Pain Inventory (BPI) 24-Hour Average Pain Item (Question 3) of the BPI-Modified Short Form Score"|A self-reported measure of the severity of pain based on the average pain over 24-hours. Severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). BOCF endpoint was defined as the baseline value for participants discontinued during acute phase, and defined as the last non-missing observation in the treatment phase for all other randomized participants. Due to the nature of a study drug labeling error which led to a treatment crossover (see Arms), data from protocol-defined treatment groups were compromised. The results from each mixed-treatment group are presented.|Baseline, 13 weeks|Number of randomized participants with a non-missing baseline and BOCF endpoint.||units on a scale||Standard Deviation|Mean
798128|NCT00945958|Secondary|Mean Change in IOP From Baseline to Visit 7 (End of Evaluations Visit)|From the start of study (baseline visit) through week 24 (Visit 7, end of evaluations visit), the change in IOP was measured|24 weeks|From the start of the study through Week 24 (Visit 7, End of Evaluations), the change in IOP is evaluated||mm Hg||Standard Deviation|Mean
798129|NCT00945958|Primary|Number of Subjects With AEs|Subjects with treatment emergent adverse events|24 weeks|||participants|||Number
798130|NCT00946088|Secondary|Number of Days Delay of Delivery|Number of days from intervention to delivery|Up to the time of delivery|exact delivery data unavailable for one term participant||days||Full Range|Median
798131|NCT00946088|Secondary|Neonatal Congenital Abnormalities||Up to the time of neonatal discharge from the delivery hospital|||Neonates|||Number
798132|NCT00946088|Secondary|Neonatal Mortality||Up to 28 days after neonatal birth|||Participants|||Count of Participants
798133|NCT00946088|Secondary|Neonatal Morbidity||Up to 28 days after neonatal birth|||Participants|||Count of Participants
798134|NCT00946088|Secondary|Neonatal Intensive Care Unit (NICU) Admission||At time of neonatal discharge|||Participants|||Count of Participants
798135|NCT00946088|Secondary|Birthweight|Newborn birthweight in grams|At the time of newborn birth|||grams||Full Range|Mean
798136|NCT00946088|Secondary|Maternal Anticipated Adverse Medication Reaction||Up to the maternal discharge from delivery hospitalization|||Participants|||Count of Participants
798137|NCT00946088|Secondary|Maternal Chorioamnionitis||Up to maternal hospital discharge|||Participants|||Count of Participants
798138|NCT00946088|Primary|Reduction in Delivery Rate Prior to 37 Weeks Gestation|Reduction in delivery rate prior to 37 weeks gestation (preterm birth).|Up to 37 weeks of gestation|||Participants|||Count of Participants
798139|NCT00946101|Secondary|Serum HAI GMTs in All Participants, Regardless of Baseline Serostatus, Dose 2 (Day 57)|All immunogenicity analyses are based on the immunogenicity population.|Day 1, Day 57|Participants who received 2 doses of the same study vaccine (H1N1=258; Placebo=65), had valid HAI measurements from blood samples obtained at baseline and post Dose 2 were included in the analysis (H1N1=250; Placebo=62).||titer||Full Range|Geometric Mean
798140|NCT00946101|Secondary|Serum HAI GMTs in All Participants, Regardless of Baseline Serostatus, Dose 1 (Day 29)|All immunogenicity analyses are based on the immunogenicity population.|Day 1, Day 29|Participants who received Dose 1 of study vaccine (H1N1=259; Placebo=65), had valid HAI measurements from blood samples obtained at baseline and post Dose 1 were included in the analysis (H1N1=126; Placebo=32).||titer||Full Range|Geometric Mean
798141|NCT00946101|Secondary|Serum HAI Geometric Mean Titers (GMTs) in All Participants, Regardless of Baseline Serostatus, Dose 1 (Day 15)|All immunogenicity analyses are based on the immunogenicity population.|Day 1, Day 15|Participants who received Dose 1 of study vaccine (H1N1=259; Placebo=65), had valid HAI measurements from blood samples obtained at baseline and post Dose 1 were included in the analysis (H1N1=129; Placebo=32).||titer||Full Range|Geometric Mean
798142|NCT00946101|Secondary|Number of Participants Who Achieve a Post Dose 2 (Day 57) HAI Titer Greater Than or Equal to 32 Against the H1N1 Strain in All Participants, Regardless of Baseline Serostatus.|All immunogenicity analyses are based on the immunogenicity population.|Day 1, Day 57|Participants who received 2 doses of the same study vaccine (H1N1=258; Placebo=65), had valid HAI measurements from blood samples obtained at baseline and post Dose 2 were included in the analysis (H1N1=250; Placebo=62).||participants|||Number
798143|NCT00946101|Secondary|Number of Participants Who Achieve a Post Dose 1 (Day 29) HAI Titer Greater Than or Equal to 32 Against the H1N1 Strain in All Participants, Regardless of Baseline Serostatus.|All immunogenicity analyses are based on the immunogenicity population.|Day 1, Day 29|Participants who received Dose 1 of study vaccine (H1N1=259; Placebo=65), had valid HAI measurements from blood samples obtained at baseline and post Dose 1 were included in the analysis (H1N1=126; Placebo=32).||participants|||Number
798144|NCT00946101|Secondary|Number of Participants Who Achieve a Post Dose 1 (Day 15) HAI Titer Greater Than or Equal to 32 Against the H1N1 Strain in All Participants, Regardless of Baseline Serostatus.|All immunogenicity analyses are based on the immunogenicity population.|Day 1, Day 15|Participants who received Dose 1 of study vaccine (H1N1=259; Placebo=65), had valid HAI measurements from blood samples obtained at baseline and post Dose 1 were included in the analysis (H1N1=129; Placebo=32).||participants|||Number
798145|NCT00946101|Secondary|Number of Participants With SAEs Within 180 Days Post Final Dose of Investigational Product.|SAEs were those AEs that resulted in death; were immediately life threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly in the offspring of a participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed above.|Days 1-209|The safety population included all participants who received at least one dose of investigational product (H1N1=259; Placebo=65) and experienced any follow-up for safety (H1N1=259; Placebo=65).||participants|||Number
798160|NCT00946101|Secondary|Number of Participants Using Anti-pyretic and Analgesic Agents Within 7 Days After Vaccination With Investigational Product, Dose 1||Days 1-8|The safety population included all participants who received at least one dose of investigational product (H1N1=259; Placebo=65) and experienced any follow-up for safety (H1N1=259; Placebo=65).||participants|||Number
799117|NCT00951912|Primary|Percentage Change in Triglyceride|(6th month value-baseline value)/baseline value*100%|Baseline, 6 months|The number of participants for analysis was determinted by intention to treat||Percentage of change||Standard Deviation|Mean
798146|NCT00946101|Secondary|Number of Participants With NOCDs Within 180 Days Post Final Dose of Investigational Product.|An NOCD was a newly diagnosed medical condition that was of a chronic, ongoing nature and was assessed by the investigator as medically significant. Examples of NOCDs included, but were not limited to, diabetes, asthma, autoimmune disease (eg, lupus, rheumatoid arthritis), and neurological disease (eg, epilepsy, autism). Examples of events not considered NOCDs were mild eczema, diagnosis of a congenital anomaly present at study entry, or acute illness (eg, otitis media, bronchitis).|Days 1-209|The safety population included all participants who received at least one dose of investigational product (H1N1=259; Placebo=65) and experienced any follow-up for safety (H1N1=259; Placebo=65).||Participants|||Number
798147|NCT00946101|Secondary|Number of Participants With SAEs Within 28 Days After Vaccination With Investigational Product, Dose 2|SAEs were those AEs that resulted in death; were immediately life threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly in the offspring of a participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed above.|Days 29-57|The safety population included all participants who received Dose 2 (H1N1=258; Placebo=65) and experienced any follow-up for safety (H1N1=255; Placebo=63).||participants|||Number
798148|NCT00946101|Secondary|Number of Participants With NOCDs Within 28 Days After Vaccination With Investigational Product, Dose 2.|An NOCD was a newly diagnosed medical condition that was of a chronic, ongoing nature and was assessed by the investigator as medically significant. Examples of NOCDs included, but were not limited to, diabetes, asthma, autoimmune disease (eg, lupus, rheumatoid arthritis), and neurological disease (eg, epilepsy, autism). Examples of events not considered NOCDs were mild eczema, diagnosis of a congenital anomaly present at study entry, or acute illness (eg, otitis media, bronchitis).|Days 29-57|The safety population included all participants who received Dose 2 (H1N1=258; Placebo=65) and experienced any follow-up for safety (H1N1=255; Placebo=63).||participants|||Number
798149|NCT00946101|Secondary|Number of Participants With Serious Adverse Events (SAEs) Within 28 Days After Vaccination With Investigational Product, Dose 1|SAEs were those AEs that resulted in death; were immediately life threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly in the offspring of a participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed above.|Days 1-29|The safety population included all participants who received at least one dose of investigational product (H1N1=259; Placebo=65) and experienced any follow-up for safety (H1N1=259; Placebo=65).||participants|||Number
798150|NCT00946101|Secondary|Number of Participants With New Onset Chronic Diseases (NOCDs) Within 28 Days After Vaccination With Investigational Product, Dose 1.|An NOCD was a newly diagnosed medical condition that was of a chronic, ongoing nature and was assessed by the investigator as medically significant. Examples of NOCDs included, but were not limited to, diabetes, asthma, autoimmune disease (eg, lupus, rheumatoid arthritis), and neurological disease (eg, epilepsy, autism). Examples of events not considered NOCDs were mild eczema, diagnosis of a congenital anomaly present at study entry, or acute illness (eg, otitis media, bronchitis).|Days 1-29|The safety population included all participants who received at least one dose of investigational product (H1N1=259; Placebo=65) and experienced any follow-up for safety (H1N1=259; Placebo=65).||participants|||Number
798151|NCT00946101|Secondary|Number of Participants Using Anti-pyretic and Analgesic Agents Within 14 Days After Vaccination With Investigational Product, Dose 2||Days 29-43|The safety population included all participants who received Dose 2 (H1N1=258; Placebo=65), experienced any follow-up for safety (H1N1=255; Placebo=63).||participants|||Number
798152|NCT00946101|Secondary|Number of Participants Reporting AEs Within 14 Days After Vaccination With Investigational Product, Dose 2||Days 29-43|The safety population included all participants who received Dose 2 (H1N1=258; Placebo=65), experienced any follow-up for safety (H1N1=255; Placebo=63).||participants|||Number
798153|NCT00946101|Secondary|Number of Participants With Any Solicited Symptoms Within 14 Days After Vaccination With Investigational Product, Dose 2||Days 29-43|The safety population for solicited symptoms Dose 2 included all participants who received Dose 2 (H1N1=258; Placebo=65), experienced any follow-up for safety and had solicited symptom data available during the reporting period (H1N1=255; Placebo=63).||participants|||Number
798154|NCT00946101|Secondary|Number of Participants Using Anti-pyretic and Analgesic Agents Within 7 Days After Vaccination With Investigational Product, Dose 2||Days 29-36|The safety population included all participants who received Dose 2 (H1N1=258; Placebo=65) and experienced any follow-up for safety (H1N1=255; Placebo=63).||participants|||Number
798155|NCT00946101|Secondary|Number of Participants Reporting AEs Within 7 Days After Vaccination With Investigational Product, Dose 2||Days 29-36|The safety population included all participants who received Dose 2 (H1N1=258; Placebo) and experienced any follow-up for safety (H1N1=255; Placebo=63).||participants|||Number
798156|NCT00946101|Secondary|Number of Participants With Any Solicited Symptoms Within 7 Days After Vaccination With Investigational Product, Dose 2||Days 29-36|The safety population for solicited symptoms Dose 2 included all participants who received Dose 2 (H1N1=258; Placebo=65), experienced any follow-up for safety and had solicited symptom data available during the reporting period (H1N1=255; Placebo=63).||participants|||Number
798157|NCT00946101|Secondary|Number of Participants Using Anti-pyretic and Analgesic Agents Within 14 Days After Vaccination With Investigational Product, Dose 1||Days 1-15|The safety population included all participants who received at least one dose of investigational product (H1N1=259; Placebo=65) and experienced any follow-up for safety (H1N1=259; Placebo=65).||participants|||Number
798158|NCT00946101|Secondary|Number of Participants Reporting AEs Within 14 Days After Vaccination With Investigational Product, Dose 1||Days 1-15|The safety population included all participants who received at least one dose of investigational product (H1N1=259; Placebo=65) and experienced any follow-up for safety (H1N1=259; Placebo=65).||participants|||Number
799118|NCT00951912|Primary|Percentage Change in Total Cholesterol|(6th month value-baseline value)/baseline value*100%|Baseline, 6 months|The number of participants for analysis was determinted by intention to treat||Percentage of change||Standard Deviation|Mean
798161|NCT00946101|Secondary|Number of Participants Reporting Adverse Events (AEs) Within 7 Days After Vaccination With Investigational Product, Dose 1||Days 1-8|The safety population included all participants who received at least one dose of investigational product (H1N1=259; Placebo=65) and experienced any follow-up for safety (H1N1=259; Placebo=65).||participants|||Number
798162|NCT00946101|Secondary|Number of Participants With Any Solicited Symptoms Within 7 Days After Vaccination With Investigational Product, Dose 1|Other solicited symptoms include fever (> 100°F [37.8°C] axillary), runny/stuffy nose, sore throat, cough, headache, generalized muscle aches, decreased activity level (lethargy) or tiredness/weakness, decreased appetite.|Days 1-8|The safety population included all participants who received at least one dose of investigational product (H1N1=259; Placebo=65), experienced any follow-up for safety and had solicited symptoms data available during the reporting period (H1N1=259; Placebo=65).||participants|||Number
798163|NCT00946101|Primary|Number of Participants Who Experience a Post Dose 2 (Day 57) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus|Seroresponse is described as greater than or equal to a 4-fold rise in HAI titer from baseline. All immunogenicity analyses are based on the immunogenicity population.|Day 1, Day 57|Participants who received 2 doses of the same study vaccine (H1N1=258; Placebo=65) and had valid HAI measurements from blood samples obtained at baseline and post Dose 2 were included in the analysis (H1N1=250; Placebo=62).||participants|||Number
798164|NCT00946101|Primary|Number of Participants Who Experience a Post Dose 1 (Day 29) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus|Seroresponse is described as greater than or equal to a 4-fold rise in HAI titer from baseline. All immunogenicity analyses are based on the immunogenicity population.|Day 1, Day 29|Participants who received Dose 1 of study vaccine (H1N1=259; Placebo=65) and had valid HAI measurements from blood samples obtained at baseline and post Dose 1 (H1N1=126; Placebo=32).||participants|||Number
798165|NCT00946101|Primary|Number of Participants Who Experience a Post Dose 1 (Day 15) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus|Seroresponse is described as greater than or equal to a 4-fold rise in hemagglutination inhibition (HAI) titer from baseline. All immunogenicity analyses was based on the immunogenicity population.|Day 1, Day 15|Participants who received Dose 1 of study vaccine (H1N1=259; Placebo=65), had valid HAI measurements from blood samples obtained at baseline and post Dose 1 were included in the analysis (H1N1=129; Placebo=32).||participants|||Number
798166|NCT00946101|Primary|Number of Participants With Fever Post Dose 1 (Days 1-8), Defined as an Axillary Temperature ≥ 101°F (38.3°C).|The number of participants with fever between the two treatment groups was compared based on the upper limit of the two-sided 95% exact confidence intervals for the rate difference (Vaccine minus Placebo). The upper limit of the two-sided 95% confidence intervals was evaluated against the prespecified equivalence criterion of 10% which corresponded to the following hypotheses: H0 (null): rate difference ≥ 10%, HA (alternative): rate difference < 10%.|Days 1- 8|The safety population included all participants who received at least one dose of investigational product and experienced any follow-up for safety (H1N1=259; Placebo=65).||participants|||Number
798167|NCT00946114|Primary|Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Adverse event = any untoward medical occurrence in a subject administered study medication regardless of causality including abnormal test findings, clinically significant signs/symptoms, changes in physical examination findings, hypersensitivity, progression/worsening of underlying disease, and exposure in utero. Serious adverse event = any untoward medical occurrence at any dose that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of hospitalization, or resulted in persistent or significant disability/incapacity or congenital anomaly/birth defect.|Baseline up to 116 Weeks|Safety population: all subjects assumed to have taken at least one dose of study medication. Non-serious adverse events were reported up to 7 days after the last dose of study medication. Serious adverse events were reported up to 28 days after the last dose of study medication.||participants|||Number
798168|NCT00938366|Secondary|Percentage of Subjects With Any Treatment Emergent Adverse Events (TEAEs), Serious AEs, AEs Leading to Death, and AEs Leading to Discontinuation|An AE was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 1 year, that were absent before treatment or that worsened relative to pre treatment state. AEs Leading to Death and AEs Leading to Discontinuation were also presented in the outcome measure.|Up to 1 year|Safety analysis set included all the randomized subjects who received treatment with at least one dose of either cladribine or pantoprazole during the study period.||percentage of subjects|||Number
798169|NCT00938366|Other Pre-specified|Apparent Volume of Distribution During the Terminal Phase Following Extravascular Administration (Vz/f) of Cladribine|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|Pre-dose (within 30 minutes prior to dosing) and at 0.5,1, 3, 6, 8, 12,16, 24, 36, 48 Hour post-dose|The PK analysis set included all the subjects who received cladribine alone and cladribine + pantoprazole according to the randomization and completed the full PK sampling.||liter||Geometric Coefficient of Variation|Geometric Mean
798170|NCT00938366|Secondary|Total Body Clearance From Plasma Following Extravascular Administration (CL/f) of Cladribine|Clearance of a drug was a measure of the rate at which cladribine is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose was influenced by the fraction of the dose absorbed.|Pre-dose (within 30 minutes prior to dosing) and at 0.5,1, 3, 6, 8, 12,16, 24, 36, 48 Hour post-dose|The PK analysis set included all the subjects who received cladribine alone and cladribine + pantoprazole according to the randomization and completed the full PK sampling.||liter/hour||Geometric Coefficient of Variation|Geometric Mean
798184|NCT00938392|Secondary|Number of Subjects Seropositive Against the 3 Vaccine Strains|A seropositive subject was defined as a subject with a serum HI titer greater than or equal to 1:10. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane.|At Days 0 and 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom data concerning immunogenicity outcome variable measures were available for the specific time point.||Subjects|||Number
798171|NCT00938366|Secondary|Apparent Terminal Half-life (t1/2) of Cladribine|The apparent terminal half-life was defined as the time required for the plasma concentration of drug cladribine to decrease 50 percent (%) in the final stage of its elimination.|Pre-dose (within 30 minutes prior to dosing) and at 0.5,1, 3, 6, 8, 12,16, 24, 36, 48 Hour post-dose|The PK analysis set included all the subjects who received cladribine alone and cladribine + pantoprazole according to the randomization and completed the full PK sampling.||hour||Geometric Coefficient of Variation|Geometric Mean
798172|NCT00938366|Secondary|Time to Reach the Maximum Plasma Concentration (Tmax) of Cladribine|The tmax was defined as time taken by the drug cladribine to reach Cmax.|Pre-dose (within 30 minutes prior to dosing) and at 0.5,1, 3, 6, 8, 12,16, 24, 36, 48 Hour post-dose|The PK analysis set included all the subjects who received cladribine alone and cladribine + pantoprazole according to the randomization and completed the full PK sampling.||hour||Full Range|Median
798173|NCT00938366|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of Cladribine|The AUC(0-inf) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity.|Pre-dose (within 30 minutes prior to dosing) and at 0.5,1, 3, 6, 8, 12,16, 24, 36, 48 Hour post-dose|The PK analysis set included all the subjects who received cladribine alone and cladribine + pantoprazole according to the randomization and completed the full PK sampling.||hour*nanogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
798174|NCT00938366|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) of Cladribine|The AUC (0-t) was defined as the area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t).|Pre-dose (within 30 minutes prior to dosing) and at 0.5,1, 3, 6, 8, 12,16, 24, 36, 48 Hour post-dose|The PK analysis set included all the subjects who received cladribine alone and cladribine + pantoprazole according to the randomization and completed the full PK sampling.||hour*nanogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
798175|NCT00938366|Primary|Maximum Plasma Concentration (Cmax) of Cladribine|The maximum or peak plasma concentration observed after the administration of cladribine.|Pre-dose (within 30 minutes prior to dosing) and at 0.5,1, 3, 6, 8, 12,16, 24, 36, 48 Hour post-dose|Pharmacokinetic (PK) analysis set included all the subjects who received cladribine alone and cladribine + pantoprazole according to the randomization and completed the full PK sampling.||nanogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
798176|NCT00938392|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the entire study period (up to Day 21)|The analysis was performed on the Total Vaccinated Cohort including all vaccinated subjects.||Subjects|||Number
798177|NCT00938392|Secondary|Number of Subjects Reporting Adverse Events of Specific Interest (AESI)|AESIs for safety monitoring included autoimmune diseases and other immune mediated inflammatory disorders.|During the 21-day post-vaccination period|The analysis was performed on the Total Vaccinated Cohort including all vaccinated subjects.||Subjects|||Number
798178|NCT00938392|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 21-day post-vaccination period|The analysis was performed on the Total Vaccinated Cohort including all vaccinated subjects.||Subjects|||Number
798179|NCT00938392|Secondary|Duration of Solicited Local and General Symptoms|Local symptoms assessed include ecchymosis, pain, redness and swelling. General symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, muscle aches, shivering and fever. Duration is expressed as median number of days the specific symptom was experienced.|During the 7-day post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, on those subjects reporting the specific symptom only.||Days||Full Range|Median
798180|NCT00938392|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms|Local symptoms assessed include ecchymosis, pain, redness and swelling. General symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, muscle aches, shivering and fever [oral temperature greater than or equal to 38 degrees Celsius (°C)]. Grade 3 pain: considerable pain at rest, which prevented normal everyday activities. Grade 3 ecchymosis, redness and swelling: more than 100 millimeter. Grade 3 fever: oral temperature greater than or equal to 39°C. Related: general symptom assessed by the investigator as causally related to the study vaccination.|During the 7-day post-vaccination period|The analysis was performed on the Total Vaccinated Cohort including all vaccinated subjects with their symptom sheet completed.||Subjects|||Number
798181|NCT00938392|Secondary|Number of Subjects Seroprotected for the 3 Vaccine Strains|A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.|At Days 0 and 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom data concerning immunogenicity outcome variable measures were available for the specific time point.||Subjects|||Number
798182|NCT00938392|Secondary|Seroconversion Factor for the 3 Vaccine Strains|Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane.|At Day 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom data concerning immunogenicity outcome variable measures were available for the specific time points.||Fold Increase||95% Confidence Interval|Geometric Mean
798183|NCT00938392|Secondary|Number of Subjects Seroconverted for the 3 Vaccine Strains|A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a four-fold increase in post-vaccination titer. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane.|At Day 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom data concerning immunogenicity outcome variable measures were available for the specific time points.||Subjects|||Number
798204|NCT00938457|Secondary|Patient Clinical Response and Treatment Effects on Blood Chemistry and Hepatic Function Markers (Phase I)||Up to 2 years||||||
798185|NCT00938392|Primary|Serum Haemagglutination-Inhibition (HI) Antibody Titers Against the 3 Vaccine Strains|Titers are presented as Geometric Mean Titers. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane.|At Days 0 and 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom data concerning immunogenicity outcome variable measures were available for the specific time point.||Titer||95% Confidence Interval|Geometric Mean
798186|NCT00938431|Secondary|Plasma Ctrough Values for SPM 12809 at Day 42|"SPM 12809 is major metabolite of LCM and is known as O-desmethyl-lacosamide. During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM.
The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point."|Day 42|"The analysis consists of the Safety Set, which is all subjects who signed the informed consent form and took at least 1 dose of LCM in SP0847.
The number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point."||μg/mL||Geometric Coefficient of Variation|Geometric Mean
798187|NCT00938431|Secondary|Plasma Ctrough Values for SPM 12809 at Day 35|"SPM 12809 is major metabolite of LCM and is known as O-desmethyl-lacosamide. During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM.
The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point."|Day 35|"The analysis consists of the Safety Set, which is all subjects who signed the informed consent form and took at least 1 dose of LCM in SP0847.
The number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point."||μg/mL||Geometric Coefficient of Variation|Geometric Mean
798188|NCT00938431|Secondary|Plasma Ctrough Values for SPM 12809 at Day 28|"SPM 12809 is major metabolite of LCM and is known as O-desmethyl-lacosamide. During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM.
The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point."|Day 28|"The analysis consists of the Safety Set, which is all subjects who signed the informed consent form and took at least 1 dose of LCM in SP0847.
The number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point."||μg/mL||Geometric Coefficient of Variation|Geometric Mean
798189|NCT00938431|Secondary|Plasma Ctrough Values for SPM 12809 at Day 7|"SPM 12809 is major metabolite of LCM and is known as O-desmethyl-lacosamide. During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM.
The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point."|Day 7|"The analysis consists of the Safety Set, which is all subjects who signed the informed consent form and took at least 1 dose of LCM in SP0847.
The number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point."||μg/mL||Geometric Coefficient of Variation|Geometric Mean
798190|NCT00938431|Secondary|Plasma Ctrough Values for Lacosamide at Day 42|"During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM.
The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point."|Day 42|"The analysis consists of the Safety Set, which is all subjects who signed the informed consent form and took at least 1 dose of LCM in SP0847.
The number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point."||μg/mL||Geometric Coefficient of Variation|Geometric Mean
798205|NCT00938457|Secondary|Toxicity and Adverse Events Profile (Phase I)|"Number of patients with a grade >= 3 adverse event.
Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.
Description of Grades:
Grade 1: Mild Grade 2: Moderate Grade 3: Severe Grade 4: Life-threatening Grade 5: Death"|Up to 2 years|||participants|||Number
798191|NCT00938431|Secondary|Plasma Ctrough Values for Lacosamide at Day 35|"During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM.
The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point."|Day 35|"The analysis consists of the Safety Set, which is all subjects who signed the informed consent form and took at least 1 dose of LCM in SP0847.
The number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point."||μg/mL||Geometric Coefficient of Variation|Geometric Mean
798192|NCT00938431|Secondary|Plasma Ctrough Values for Lacosamide at Day 28|"During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM.
The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point."|Day 28|"The analysis consists of the Safety Set, which is all subjects who signed the informed consent form and took at least 1 dose of LCM in SP0847.
The number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point."||μg/mL||Geometric Coefficient of Variation|Geometric Mean
798193|NCT00938431|Secondary|Plasma Ctrough Values for Lacosamide at Day 7|"During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM.
The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point."|Day 7|"The analysis consists of the Safety Set, which is all subjects who signed the informed consent form and took at least 1 dose of LCM in SP0847.
The number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point."||μg/mL||Geometric Coefficient of Variation|Geometric Mean
798194|NCT00938431|Secondary|Clinical Global Impression of Change Score at Visit 5 (Day 27/28) or Early Termination|"For assessment of the Clinical Global Impression of Change, the investigator provided his/her assessment of the subject's clinical status, compared to Baseline (Visit 1), including an evaluation of seizure frequency and intensity, the occurrence of AEs, and subject's functional status.
The investigator will be asked to check the number that best describes the subject's condition over the past 4 weeks compared to Baseline:
Very much improved
Much improved
Minimally improved
No Change
Minimally worse
Much worse
Very much worse"|Visit 5 (Day 27/28) or Early Termination|"This analysis consists of the Full Analysis Set, which is all subjects from the Safety Set who have at least 1 post-Baseline seizure diary day with available data during the SP0847 study.
For one subject in the age group >=12 years to <=17 years no data is available."||Participants|||Number
798195|NCT00938431|Secondary|Caregiver Global Impression of Change Score at Visit 5 (Day 27/28) or Early Termination|"For the assessment of the Caregiver Global Impression of Change, the caregiver (including parent/legal guardian) provided his/her assessment of the subject's clinical status, compared to Baseline (Visit 1), including an evaluation of seizure frequency and intensity, the occurrence of Adverse Events (AEs), and subject's functional status.
The caregiver will be asked to check the number that best describes the subject's condition over the past 4 weeks compared to Baseline:
Very much improved
Much improved
Minimally improved
No change
Minimally worse
Much worse
Very much worse"|Visit 5 (Day 27/28) or Early Termination|This analysis consists of the Full Analysis Set, which is all subjects from the Safety Set who have at least 1 post-Baseline seizure diary day with available data during the SP0847 study.||Participants|||Number
798196|NCT00938431|Secondary|Change in Seizure Frequency From Baseline to End of Treatment||From Baseline to End of Treatment (approximately 13 weeks)|This analysis consists of the Full Analysis Set, which is all subjects from the Safety Set who have at least 1 post-Baseline seizure diary day with available data during the SP0847 study.||percentage change||Standard Deviation|Mean
798197|NCT00938431|Primary|Number of Subjects That Report at Least One Treatment-emergent Adverse Event During the Study (Approximately 13 Weeks)||13 weeks|The analysis consists of the Safety Set (SS), which is all subjects who signed the informed consent form and took at least 1 dose of Lacosamide (LCM) in SP0847.||participants|||Number
798198|NCT00938457|Secondary|Evaluation of Cause of Death (Phase II)||Up to 5 years|No patients were accrued to the Phase II portion.|||||
798199|NCT00938457|Secondary|Refinement of Patient Clinical Response and Treatment Effects on Blood Chemistry and Hepatic Function Markers (Phase II)||Up to 2 years|No patients were accrued to the Phase II portion.|||||
798200|NCT00938457|Secondary|Refinement of Toxicity and Adverse Events Profile (Phase II)||Up to 2 years|No patients were accrued to the Phase II portion.|||||
798201|NCT00938457|Secondary|Median Time to Progression of Treated Tumors (Phase II)||Up to 5 years|No patients were accrued to the Phase II portion.|||||
798202|NCT00938457|Secondary|Local Control (LC) Cumulative Incidence Rates (Phase II)||3 and 6 months and 1, 2, and 5 years|No patients were accrued to the Phase II portion.|||||
798203|NCT00938457|Secondary|Radiographic Response Rate (Phase II)||Up to 2 years|No patients were accrued to the Phase II portion.|||||
798206|NCT00938457|Primary|Determine the Minimum Effective Dose (MED) Necessary for Durable Local Control, Defined as the Dose Level at Which Local Control (LC) is >= 80% at 1 Year. (Phase II)|LC is defined as no evidence of disease progression within the volume treated to prescription dose (i.e. PTV) for a specific lesion. The development of new intrahepatic metastases sites outside of the PTV will not be considered local failures.|At 1 year|No patients were accrued to the Phase II portion.|||||
798207|NCT00938457|Primary|Determination of the Maximum Tolerated Dose (MTD) of Single-fraction Stereotactic Body Radiation Therapy (SF-SBRT) in Hepatic Metastases.||2 months|Not enough patients were accrued to the Phase I portion to determine the MTD.|||||
798208|NCT00938470|Secondary|Percentage of Participants With Overall Clinical Tumor Response (CR or PR)|Overall clinical tumor response rate was defined as the percentage of evaluable participants who achieved either complete response (CR) or partial response (PR) noted on the objective status from pre-surgical staging (for arm II) or either from pre-RT or pre-surgical staging (for arm I). > CR was defined as disappearance of all non-target lesion (TL) and normalization of tumor biomarker level, all lymph nodes (LN) must be non-pathological in size (<1 cm short axis); or disappearance of all TL and normalization of tumor biomarkers, any pathological LN (whether target or non-target) must have reduction in short axis to <1 cm; or >=30% decrease in the sum of the diameters of TL taking as reference the baseline sum of the diameters.|Up to 2 years|Eligible randomized participants who initiated first cycle of protocol treatment.||percentage of participants||95% Confidence Interval|Number
798209|NCT00938470|Secondary|Number of Participants Who Experienced a Maximum Grade of 3 or Above Adverse Event|Adverse events were assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.|Up to 2 years|Eligible randomized participants who initiated first cycle of protocol treatment.||Participants|||Count of Participants
798210|NCT00938470|Secondary|Disease-free Survival|Disease-free survival was defined as the time from randomization to the date of recurrent or death, whichever comes first.|Up to 2 years|Eligible randomized participants who initiated first cycle of protocol treatment.||months||95% Confidence Interval|Median
798211|NCT00938470|Secondary|Overall Survival|Overall survival was defined as the time from randomization to the time of death from any cause. Overall survival was censored at the date of last follow-up visit for patients who are still alive or loss of follow-up.|Up to 2 years|Eligible randomized participants who initiated first cycle of protocol treatment.||months||95% Confidence Interval|Median
798212|NCT00938470|Primary|Percentage of Participants With Pathologic Complete Response (PCR)|Pathologic complete response was defined as no gross or microscopic tumor identified with the surgical specimen. All lymph nodes should be free of tumor to document a PCR. If no gross tumor is visible, section around the area of inflammation (nodularity) should be made every 2-3 cm and specimens examined.|Up to 2 years|Eligible randomized participants who initiated first cycle of protocol treatment.||percentage of participants||95% Confidence Interval|Number
798213|NCT00938548|Secondary|Pain Scores (VNRS) at 1 Week and 1 Month After Operation|Pain was evaluated using an 11-point verbal numerical rating scale (VNRS). Patients were instructed preoperatively to express their pain on the 0–10 VNRS, where 0 represents no pain at all and 10 represents the worst pain imaginable.|1 week, 1 month|||Units on a scale||Standard Deviation|Mean
798214|NCT00938548|Primary|Number of Participants With the Indicated Side Effects - Nausea & Vomiting, Sedation, Headache, Dizziness Etc.|Nausea and vomiting was graded on a four-point scale, where 0 = no nausea, 1 = mild nausea, 2 = severe nausea requiring antiemetics, and 3 = retching and/ or vomiting. Grades 3 and 4 were grouped together as postoperative nausea and vomiting (PONV) and rescue anti-emetic, metoclopramide 10 mg i.v. was given.|1, 6, 24, 48 hour|||participants|||Number
798215|NCT00938548|Primary|Pain Scores (Verbal Numerical Rating Scale;VNRS) During Postoperative Hours.|Pain was evaluated using an 11-point verbal numerical rating scale (VNRS). Patients were instructed preoperatively to express their pain on the 0–10 VNRS, where 0 represents no pain at all and 10 represents the worst pain imaginable.|1, 6, 24, 48 hour|||Units on a scale||Full Range|Median
798216|NCT00938639|Secondary|Frequency and Intensity of Unsolicited AEs|"Unsolicited AEs included AEs other than those specifically sought for.
The grading definitions were:
Mild (Grade 1): Symptoms were easily tolerated and did not interfere with daily activities.
Moderate (Grade 2): Enough discomfort to cause some interference with daily activities.
Severe (Grade 3): Incapacitating, with inability to work or do usual activities."|From Day 0 to Day 20 after vaccination; up to 180 days after the last vaccination for SAEs, AESIs, and NOCIs|The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.||percentage of participants|||Number
798217|NCT00938639|Secondary|Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs)|An AESI was defined as an AE for which the association with seasonal influenza vaccine was unclear. A NOCI was defined as the diagnosis of a new medical condition that was chronic in nature, including those potentially controllable by medication (eg, diabetes, asthma).|Up to 180 days after the last vaccination|The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.||percentage of participants|||Number
798218|NCT00938639|Secondary|Duration of Solicited Systemic AEs After the Second Vaccination|Solicited AEs included AEs that were specifically sought for.|From Day 0 to Day 6 after the second vaccination and up to Day 20 after the second vaccination if AE is ongoing at Day 7|The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.||days||Standard Deviation|Mean
798219|NCT00938639|Secondary|Frequency and Intensity of Solicited Systemic AEs After the Second Vaccination|Solicited AEs included AEs that were specifically sought for. Grade 3 solicited AE definitions: Prevented normal daily activities; Temperature 102.2°F (39.0°C) or more for fevers.|From Day 0 to Day 6 after the second vaccination|The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.||percentage of participants|||Number
798220|NCT00938639|Secondary|Duration of Solicited Systemic AEs After the First Vaccination|Solicited AEs included AEs that were specifically sought for.|From Day 0 to Day 6 after the first vaccination and up to Day 20 after the first vaccination if AE is ongoing at Day 7|The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.||days||Standard Deviation|Mean
801429|NCT00972543|Secondary|Heart Rate||Measure at Day 0, Day 7, Week 8, Week 16 and Follow Up and Early Termination visits|Results not analysed due to early termination of the study|||||
798221|NCT00938639|Secondary|Frequency and Intensity of Solicited Systemic AEs After the First Vaccination|Solicited AEs included AEs that were specifically sought for. Grade 3 solicited AE definitions: Prevented normal daily activities; Temperature 102.2°F (39.0°C) or more for fevers.|From Day 0 to Day 6 after the first vaccination|The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.||percentage of participants|||Number
798222|NCT00938639|Secondary|Duration of Solicited Local AEs After the Second Vaccination|Solicited AEs included AEs that were specifically sought for.|From Day 0 to Day 6 after the second vaccination and up to Day 20 after the second vaccination if AE is ongoing at Day 7|The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.||days||Standard Deviation|Mean
798223|NCT00938639|Secondary|Frequency and Intensity of Solicited Local AEs After the Second Vaccination|Solicited AEs included AEs that were specifically sought for. Grade 3 solicited AE definitions: Prevented normal daily activities; Size > 100 mm for injection site redness, induration/swelling, and bruising.|From Day 0 to Day 6 after the second vaccination|The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.||percentage of participants|||Number
798224|NCT00938639|Secondary|Duration of Solicited Local AEs After the First Vaccination|Solicited AEs included AEs that were specifically sought for.|From Day 0 to Day 6 after the first vaccination and up to Day 20 after the first vaccination if AE is ongoing at Day 7|The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.||days||Standard Deviation|Mean
798225|NCT00938639|Secondary|Frequency and Intensity of Solicited Local Adverse Events (AEs) After the First Vaccination|Solicited AEs included AEs that were specifically sought for. Grade 3 solicited AE definitions: Prevented normal daily activities; Size > 100 mm for injection site redness, induration/swelling, and bruising.|From Day 0 to Day 6 after the first vaccination|The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.||percentage of participants|||Number
798226|NCT00938639|Secondary|Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More 180 Days After the Second Vaccination||180 days after the second vaccination|The Evaluable Population comprised all randomised participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).||percentage of participants||95% Confidence Interval|Number
798227|NCT00938639|Secondary|GMFI in the HI Antibody Titre 180 Days After the Second Vaccination|The GMFI in antibody titre was calculated by taking the anti-logs of the means of the log transformed fold-increases in the antibody titre 180 days after the second vaccination over the antibody titre 21 days after the second vaccination.|21 days and 180 days after the second vaccination|The Evaluable Population comprised all randomised participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).||geometric mean fold increase||95% Confidence Interval|Geometric Mean
798228|NCT00938639|Secondary|Percentage of Participants With a Baseline Titre Greater Than or Equal to 1:10 Achieving Seroconversion After Vaccination|"The number of participants with a baseline titre greater than or equal to 1:10 differed according to antibody assay (HI or MN) and is shown in the category titles accordingly. The total number of participants analysed includes all evaluable participants; however, the analysis is stratified by baseline titre and those participants with a baseline titre of 1:10 or more are presented in this outcome measure while those with a baseline titre less than 1:10 are presented in a separate outcome measure.
Antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination titre of 1:40 or more; or participants with a pre-vaccination titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre (ie, a significant increase in antibody titre after vaccination)."|Before and 21 days after each vaccination|The Evaluable Population comprised all randomised participants who received the study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).||percentage of participants||95% Confidence Interval|Number
798229|NCT00938639|Secondary|Percentage of Participants With a Baseline Titre Less Than 1:10 Achieving Seroconversion After Vaccination|"The number of participants with a baseline titre less than 1:10 differed according to antibody assay (HI or MN) and is shown in the category titles accordingly. The total number of participants analysed includes all evaluable participants; however, the analysis is stratified by baseline titre and those participants with a baseline titre less than 1:10 are presented in this outcome measure while those with a baseline titre of 1:10 or more are presented in a separate outcome measure.
Antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination titre of 1:40 or more; or participants with a pre-vaccination titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre."|Before and 21 days after each vaccination|The Evaluable Population comprised all randomised participants who received the first (or second, as appropriate) study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).||percentage of participants||95% Confidence Interval|Number
798230|NCT00938639|Secondary|Percentage of Participants Achieving a HI or MN Antibody Titre of 1:40 or More After the Second Vaccination by Age Group|Adults were aged from 18 to 49 years; Older adults were aged from 50 to 64 years.|21 days after the second vaccination|The Evaluable Population (for the second vaccination) comprised all randomised participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).||percentage of participants||95% Confidence Interval|Number
798334|NCT00939107|Secondary|Pain|The back and leg pain questionnaire included three separate 11 point box scales comprising the following items: Low Back Pain (LBP) at the moment, the worst LBP within the past two weeks, and the average level of LBP within the last two weeks. These summed to a total score ranging from 0 points (no back or leg pain at all) to 60 points (worst possible back and leg pain on all items).|twelve months posttreatment|||Units on a scale||95% Confidence Interval|Mean
798231|NCT00938639|Secondary|Percentage of Participants Achieving a HI or MN Antibody Titre of 1:40 or More After the First Vaccination by Age Group|Adults were aged from 18 to 49 years; Older adults were aged from 50 to 64 years.|21 days after the first vaccination|The Evaluable Population (for the first vaccination) comprised all randomised participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).||percentage of participants||95% Confidence Interval|Number
798232|NCT00938639|Secondary|GMFI in the HI and MN Antibody Titre After the Second Vaccination by Age Group|"GMFI in antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre.
Adults were aged from 18 to 49 years; Older adults were aged from 50 to 64 years."|Before and 21 days after the second vaccination|The Evaluable Population (for the second vaccination) comprised all randomised participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).||geometric mean fold increase||95% Confidence Interval|Geometric Mean
798233|NCT00938639|Secondary|GMFI in the HI and MN Antibody Titre After the First Vaccination by Age Group|"GMFI in antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre.
Adults were aged from 18 to 49 years; Older adults were aged from 50 to 64 years."|Before and 21 days after the first vaccination|The Evaluable Population (for the first vaccination) comprised all randomised participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).||geometric mean fold increase||95% Confidence Interval|Geometric Mean
798234|NCT00938639|Secondary|HI and MN Antibody Titre Seroconversion Rate After the Second Vaccination by Age Group|"Antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination antibody titre of 1:40 or more; or participants with a pre-vaccination titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre.
Adults were aged from 18 to 49 years; Older adults were aged from 50 to 64 years."|Before and 21 days after the second vaccination|The Evaluable Population (for the second vaccination) comprised all randomised participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).||percentage of participants||95% Confidence Interval|Number
798235|NCT00938639|Secondary|HI and MN Antibody Titre Seroconversion Rate After the First Vaccination by Age Group|"Antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination antibody titre of 1:40 or more; or participants with a pre-vaccination titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre.
Adults were aged from 18 to 49 years; Older adults were aged from 50 to 64 years."|Before and 21 days after the first vaccination|The Evaluable Population (for the first vaccination) comprised all randomised participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).||percentage of participants||95% Confidence Interval|Number
798236|NCT00938639|Primary|Percentage of Participants Achieving a HI or MN Antibody Titre of 1:40 or More After the Second Vaccination||21 days after the second vaccination|The Evaluable Population (for the second vaccination) comprised all randomised participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).||percentage of participants||95% Confidence Interval|Number
798237|NCT00938639|Primary|Percentage of Participants Achieving a HI or MN Antibody Titre of 1:40 or More After the First Vaccination||21 days after the first vaccination|The Evaluable Population (for the first vaccination) comprised all randomised participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).||percentage of participants||95% Confidence Interval|Number
798238|NCT00938639|Primary|GMFI in the HI and MN Antibody Titer After the Second Vaccination|GMFI in antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre.|Before and 21 days after the second vaccination|The Evaluable Population (for the second vaccination) comprised all randomised participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).||geometric mean fold increase||95% Confidence Interval|Geometric Mean
798239|NCT00938639|Primary|Geometric Mean Fold Increase (GMFI) in the HI and MN Antibody Titre After the First Vaccination|GMFI in antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre.|Before and 21 days after the first vaccination|The Evaluable Population (for the first vaccination) comprised all randomised participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).||geometric mean fold increase||95% Confidence Interval|Geometric Mean
798240|NCT00938639|Primary|HI and MN Antibody Titre Seroconversion Rate After the Second Vaccination|Antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination antibody titre of 1:40 or more; or participants with a pre-vaccination titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre.|Before and 21 days after the second vaccination|The Evaluable Population (for the second vaccination) comprised all randomised participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).||percentage of participants||95% Confidence Interval|Number
798241|NCT00938639|Primary|Haemagglutination Inhibition (HI) and Microneutralisation (MN) Antibody Titre Seroconversion Rate After the First Vaccination|Antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination antibody titre of 1:40 or more; or participants with a pre-vaccination titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre.|Before and 21 days after the first vaccination|The Evaluable Population (for the first vaccination) comprised all randomised participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).||percentage of participants||95% Confidence Interval|Number
798242|NCT00938704|Secondary|Change From Baseline in Conjunctival Staining (Nasal) at Week 2|Change from baseline in conjunctival staining (nasal) at Week 2. Staining of the conjunctiva following ocular administration of lissamine green dye was graded using a 6-point scale (0=no staining, 5=diffuse staining). The higher the grade score, the worse the dry eye severity. A negative number change from baseline indicates improvement.|Baseline, Week 2|Intent-to-Treat (ITT). The ITT population consisted of all patients who started the study (randomized).||Scores on a Scale||Standard Deviation|Mean
798243|NCT00938704|Secondary|Change From Baseline in Conjunctival Staining (Temporal) at Week 2|Change from baseline in conjunctival (temporal) staining at Week 2. Staining of the conjunctiva following ocular administration of lissamine green dye was graded using a 6-point scale (0=no staining, 5=diffuse staining). The higher the grade score, the worse the dry eye severity. A negative number change from baseline indicates improvement.|Baseline, Week 2|Intent-to-Treat (ITT). The ITT population consisted of all patients who started the study (randomized).||Scores on a Scale||Standard Deviation|Mean
798244|NCT00938704|Secondary|Change From Baseline in Corneal Staining at Week 2|Change from baseline in corneal staining at Week 2. Staining of the cornea following ocular administration of fluorescein dye was graded using a 6-point scale (0=no staining, 5=diffuse staining). The higher the grade score, the worse the dry eye severity. A negative number change from baseline indicates improvement.|Baseline, Week 2|Intent-to-Treat (ITT). The ITT population consisted of all patients who started the study (randomized).||Scores on a Scale||Standard Deviation|Mean
798245|NCT00938704|Secondary|Change From Baseline in Tear Breakup Time (TBUT) at Week 2|Change from baseline in TBUT at Week 2. TBUT is defined as the time required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A positive number change from baseline indicates improvement.|Baseline, Week 2|Intent-to-Treat (ITT). The ITT population consisted of all patients who started the study (randomized).||Seconds||Standard Deviation|Mean
798246|NCT00938704|Primary|Change From Baseline in Ocular Surface Disease Index (OSDI) at Week 2|Change from baseline in OSDI at Week 2. The OSDI consists of 12 questions measuring the presence of ocular symptoms. Each of the 12 questions is assessed using a 5-point scale (0=none of the time; 4=all of the time). The score is converted to a 0-100 score where 0 is best and 100 is worst. Higher OSDI scores are associated with greater severity. A negative number change from baseline indicates improvement.|Baseline, Week 2|Intent-to-Treat (ITT). The ITT population consisted of all patients who started the study (randomized).||Scores on a Scale||Standard Deviation|Mean
798247|NCT00938717|Secondary|12-Week Percent of Abdominal Pain-free Days|"Abdominal pain free (APF) days are those days where the patient reported a score of '0' for abdominal pain at its worst.
Abdominal Pain at its worst (in the last 24 hours) is based on an 11-point scale where 0 represents no abdominal pain and 10 represents very severe abdominal pain."|Change from Baseline to Week 12|805 patients were randomized to treatment. 804 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.||Percent of Pain-free Days||Standard Deviation|Mean
798248|NCT00938717|Secondary|Abdominal Pain Responder for 6 Out of 12 Weeks|A patient is considered to be an AP responder if, for at least 6 out of the first 12 weeks of the treatment period, the patient had a decrease of at least 30 percent in their Abdominal Pain score from baseline during a particular week.|Change from Baseline to Week 12|805 patients were randomized to treatment. 804 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.||participants|||Number
798249|NCT00938717|Secondary|Complete Spontaneous Bowl Movement (CSBM) Responder for 6 Weeks Out of 12 Weeks of Treatment|A patient is considered to be a CSBM responder if, for at least 6 out of the 12 weeks of the treatment period, an increase of at least 1 CSBM per week from baseline was experienced.|Change from Baseline to Week 12|805 patients were randomized to treatment. 804 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.||participants|||Number
798250|NCT00938717|Secondary|12-Week Change in Bloating|"Bloating was assessed on an 11-point scale where a value of 0 is none and a value of 10 is very severe."|Change from Baseline to Week 12|805 patients were randomized to treatment. 804 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.||Units on a scale||Standard Error|Least Squares Mean
798251|NCT00938717|Secondary|12-Week Change in Abdominal Discomfort|"Abdominal discomfort was assessed on an 11-point scale where a value of 0 is none and a value of 10 is very severe."|Change from Baseline to Week 12|805 patients were randomized to treatment. 804 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.||Units on a scale||Standard Error|Least Squares Mean
798252|NCT00938717|Secondary|12-Week Change in Abdominal Pain Score|Abdominal Pain at its worst (in the last 24 hours) is based on an 11-point scale where 0 represents no abdominal pain and 10 represents very severe abdominal pain.|Change from Baseline to Week 12|805 patients were randomized to treatment. 804 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.||Units on a scale||Standard Error|Least Squares Mean
798335|NCT00939107|Primary|Disability|Problems performing daily activities measured on the 23-item modified Roland Morris Disability Questionnaire (worst: 23 points, best:0 points).|two months after treatment|Intention to treat||Units on a scale||95% Confidence Interval|Mean
798253|NCT00938717|Secondary|12-Week Change in Severity of Straining|"Straining is measured on a 5-point scale where a value of 1 is not at all and a value of 5 is an extreme amount."|Change from Baseline to Week 12|805 patients were randomized to treatment; 804 patients had at least 1 postrandomization entry of the primary efficacy assessment and included in the ITT Population; 134 patients with no pretreatment spontaneous bowel movements were excluded from the Straining analysis. An observed-cases approach to missing postbaseline data was applied.||Units on a scale||Standard Error|Least Squares Mean
798254|NCT00938717|Secondary|12-Week Change in Stool Consistency|"The consistency of each BM was assessed by patients using the 7-point Bristol Stool Form Scale (BSFS) from 1 to 7.
= separate hard lumps like nuts [difficult to pass]
= sausage shaped but lumpy
= like a sausage but with cracks on surface
= like a sausage or snake, smooth and soft
= soft blobs with clear-cut edges [passed easily]
= fluffy pieces with ragged edges, a mushy stool
= watery, no solid pieces [entirely liquid])."|Change from Baseline to Week 12|805 patients were randomized to treatment; 804 patients had at least 1 postrandomization entry of the primary efficacy assessment and included in the ITT Population; 134 patients with no pretreatment spontaneous bowel movements were excluded from the Stool Consistency analysis. An observed-cases approach to missing postbaseline data was applied.||Units on a scale||Standard Error|Least Squares Mean
798255|NCT00938717|Secondary|12-Week Spontaneous Bowl Movement (SBM) Frequency|The change from baseline in 12-week SBM frequency (i.e., weekly SBM frequency over the first 12 weeks of the Treatment Period).|Change from Baseline to Week 12|805 patients were randomized to treatment. 804 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.||SBMs per Week||Standard Error|Least Squares Mean
798256|NCT00938717|Secondary|12-Week Complete Spontaneous Bowel Movement (CSBM) Frequency|The change from baseline in 12-week CSBM frequency (i.e., weekly CSBM frequency over the first 12 weeks of the Treatment Period).|Change from Baseline to Week 12|805 patients were randomized to treatment. 804 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.||CSBMs per Week||Standard Error|Least Squares Mean
798257|NCT00938717|Primary|Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 6 Out of 12 Weeks|"A patient is considered to be a 6 out of 12 week APC responder if, for at least 6 out of the first 12 weeks of the treatment period, the patient had an increase of at least 1 CSBM from baseline, and had a decrease of at least 30 percent in their Abdominal Pain (AP) score from baseline during a particular week.
The AP score assesses patient's worst AP in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no AP and 10 represents very severe AP.
SBM is defined as a bowel movement that occurs in the absence of laxative, enema, or suppository use on either the calendar day of the bowel movement or the calendar day before the bowel movement. CSBM is defined as an SBM associated with a sense of complete evacuation."|Change from Baseline to Week 12|805 patients were randomized to treatment. 804 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.||participants|||Number
798258|NCT00938717|Primary|Abdominal Pain Responder, 9 Out of 12 Weeks|"A patient is considered to be an abdominal pain responder if, for at least 9 out of the 12 weeks of the treatment period, they experienced a decrease of at least 30 percent in the mean abdominal pain score from baseline during a particular week.
The Abdominal Pain score assesses patient's worst abdominal pain in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no abdominal pain and 10 represents very severe abdominal pain."|Change from Baseline to Week 12|805 patients were randomized to treatment. 804 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.||participants|||Number
798259|NCT00938717|Primary|Complete Spontaneous Bowel Movement (CSBM) 3+1 Responder, 9 Out of 12 Weeks|"A patient is considered to be a CSBM 3+1 responder if, for at least 9 out of the 12 weeks of the treatment period, the patient had at least 3 CSBMs and experienced an increase of at least 1 CSBM from baseline during a particular week.
A CSBM was defined as a Spontaneous Bowel Movement (SBM) that was associated with a sense of complete evacuation.
An SBM was defined as a bowel movement (BM) that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM."|Change from Baseline to Week 12|805 patients were randomized to treatment. 804 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.||participants|||Number
798260|NCT00938717|Primary|Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 9 Out of 12 Weeks|"A patient is considered to be a 9 out of 12 week APC responder if, for at least 9 out of the first 12 weeks of the treatment period, the patient had at least 3 CSBMs, had an increase of at least 1 CSBM from baseline, and had a decrease of at least 30 percent in their Abdominal Pain (AP) score from baseline during a particular week.
The AP score assesses patient's worst AP in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no AP and 10 represents very severe AP.
SBM is defined as a bowel movement that occurs in the absence of laxative, enema, or suppository use on either the calendar day of the bowel movement or the calendar day before the bowel movement. CSBM is defined as an SBM associated with a sense of complete evacuation."|Change from Baseline to Week 12|805 patients were randomized to treatment. 804 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the Intent to Treat (ITT) Population. An observed-cases approach to missing postbaseline data was applied.||participants|||Number
798261|NCT00938782|Primary|Time to Extubation|The exact time from end of last anesthetic drug to time of tracheal extubation.|Measured from time of end anesthesia to time of tracheal extubation.|All patients enrolled in both groups.||minutes||Standard Deviation|Mean
798262|NCT00938860|Secondary|Number of Participants With Dose Reduction or Discontinuation of Antiviral (AV) Therapy Due to Poor Tolerability at Any Time During the Study for Any Reason|Defined as number of patients with dose reduction or discontinuation of AV therapy due to poor tolerability|Week 80|The efficacy population was defined as a subset of the ITT population with sufficient compliance to the protocol procedures to allow meaningful conclusions. Patients were excluded from the Efficacy population in case of: Error in treatment assignment, if the randomized study medication was not initiated, antiviral therapy was not initiated||Participants|||Number
798263|NCT00938860|Secondary|Number of Participants for Relapse Rate|Defined as reappearance of detectable Hepatitis C Virus (HCV) RNA at 24 weeks after completion of antiviral treatment when HCV RNA was undetectable at the end of treatment. The HCV RNA detection limit was <15 IU/ml (<1.18 log IU/ml)|Week 24|The efficacy population was defined as a subset of the ITT population with sufficient compliance to the protocol procedures to allow meaningful conclusions. Patients were excluded from the Efficacy population in case of: Error in treatment assignment, if the randomized study medication was not initiated, antiviral therapy was not initiated||Participants|||Number
798264|NCT00938860|Secondary|Number of Participants of True Non-responder Rate|Defined as failure to achieve at least a 2 log reduction of Hepatitis C virus (HCV) RNA. The HCV RNA detection limit was <15 IU/ml (<1.18 log IU/ml)|Week 80|The efficacy population was defined as a subset of the ITT population with sufficient compliance to the protocol procedures to allow meaningful conclusions. Patients were excluded from the Efficacy population in case of: Error in treatment assignment, if the randomized study medication was not initiated, antiviral therapy was not initiated||Participants|||Number
798265|NCT00938860|Secondary|Number of Participants for the End of Treatment Response (ETR)|ETR defined as non-detectable HCV RNA at the completion of AV treatment. The HCV RNA detection limit was <15 IU/ml (<1.18 log IU/ml)|Week 80|The efficacy population was defined as a subset of the ITT population with sufficient compliance to the protocol procedures to allow meaningful conclusions. Patients were excluded from the Efficacy population in case of: Error in treatment assignment, if the randomized study medication was not initiated, antiviral therapy was not initiated||Participants|||Number
798266|NCT00938860|Secondary|Number of Participants of Early Viral Response (EVR)|EVR defined as non-detectable HCV RNA or a ≥2 logs reduction of HCV RNA at 12 weeks after initiation of antiviral treatment. The HCV RNA detection limit was <15 IU/ml (<1.18 log IU/ml)|Week 12|The efficacy population was defined as a subset of the ITT population with sufficient compliance to the protocol procedures to allow meaningful conclusions. Patients were excluded from the Efficacy population in case of: Error in treatment assignment, if the randomized study medication was not initiated, antiviral therapy was not initiated||Participants|||Number
798267|NCT00938860|Secondary|Number of Participants of Rapid Viral Response (RVR)|RVR defined as non-detectable HCV RNA 4 weeks after initiation of antiviral treatment. The HCV RNA detection limit was <15 IU/ml (<1.18 log IU/ml)|Week 4|The efficacy population was defined as a subset of the ITT population with sufficient compliance to the protocol procedures to allow meaningful conclusions. Patients were excluded from the Efficacy population in case of: Error in treatment assignment, if the randomized study medication was not initiated, antiviral therapy was not initiated||Participants|||Number
798268|NCT00938860|Secondary|Number of Participants With Fibrosis Progression (Increase in Ishak-Knodell (IK) Score by at Least One Point From the Baseline)|Ishak-Knodell Score: 0=No fibrosis; 01=Fibrous expansion of some portal areas, with or without short fibrous septa; 02=Fibrous expansion of most portal areas, with or without short fibrous septa; 03=Fibrous expansion of most portal areas, with occasional portal to portal (P-P) bridging; 04=Fibrous expansion of portal areas, with marked bridging (portal to portal (P-P) as well as portal to central (P-C)); 05=Marked bridging (P-P and/or P-C) with occasional nodules (incomplete cirrhosis); 06=Cirrhosis, probable or definite, Participants showing an increase of Ishak Knodell fibrosis score by at least one level (increase of ≥1)|Week 80|The efficacy population was defined as a subset of the ITT population with sufficient compliance to the protocol procedures to allow meaningful conclusions. Patients were excluded from the Efficacy population in case of: Error in treatment assignment, if the randomized study medication was not initiated, antiviral therapy was not initiated||Participants|||Number
798269|NCT00938860|Secondary|Number of Events of the Composite Endpoint of Biopsy Proven Acute Rejections (BPAR), Death or Graft Loss and of the Individual Components|Efficacy failure (biopsy proven acute rejection (BPAR), graft loss, or death|Week 80|Intent-to-Treat (ITT) population: The ITT population consisted of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.||Number of events|||Number
798270|NCT00938860|Primary|Number of Participants Sustained Virological Response (SVR) Following Treatment of Hepatitis C Virus (HCV) Infection With Peg-IFN and Ribavirin in Liver Transplanted Recipients on Maintenance Therapy With Neoral or Tacrolimus|The achievement of SVR, defined as HCV RNA below limit of detection at the end of AV treatment, 24 weeks after end of AV treatment (W24 post). A dichotomous variable (SVR achieved: Yes/No) was computed. A patient was classified as non-responder (SVR not achieved) if HCV RNA was detectable at the completion of antiviral treatment, at W24post, or at any time between W24 and completion of antiviral treatment. The HCV RNA detection limit was <15 IU/ml (<1.18 log IU/ml)|Week 24|The efficacy population was defined as a subset of the ITT population with sufficient compliance to the protocol procedures to allow meaningful conclusions. Patients were excluded from the Efficacy population in case of: Error in treatment assignment, if the randomized study medication was not initiated, antiviral therapy was not initiated||Participants|||Number
798271|NCT00938886|Secondary|7-day Point Prevalence Smoking Abstinence|Self-report abstinence from smoking over the past 7 days biochemically confirmed with carbon monoxide and saliva cotinine.|26 weeks after target quit smoking date|||Participants|||Count of Participants
798272|NCT00938886|Primary|Percent Heavy Drinking Days|Defined for women as percent of days drinking 4 or more drinks in a day. For men, percent of days drinking 5 or more drinks in a day|Across the 6 months following smoking quit date|||percentage of days||Standard Deviation|Mean
798273|NCT00938964|Secondary|Change in Neurological Function, as Measured by the Western Perioperative Neurologic Scale (WPNS)|The Western perioperative neurologic scale was designed to detect neurologic deficits after cardiac surgery. It includes 14 items classified into eight domains (mentation, speech, cranial nerve function, motor weakness, sensation and cerebellum, reflexes, and gait). Each item is scored from 0 (severe deficit) to3 (normal), and a maximum score of 42 indicates normal neurological function.|baseline, 1-year||05/2018||||
798274|NCT00938964|Secondary|Change in Neurological Function, as Measured by the Western Perioperative Neurologic Scale (WPNS)|The Western perioperative neurologic scale was designed to detect neurologic deficits after cardiac surgery. It includes 14 items classified into eight domains (mentation, speech, cranial nerve function, motor weakness, sensation and cerebellum, reflexes, and gait). Each item is scored from 0 (severe deficit) to3 (normal), and a maximum score of 42 indicates normal neurological function.|baseline, 6-weeks|||units on a scale||Standard Deviation|Mean
798275|NCT00938964|Secondary|Change in Study 36-Item Short Form Health Survey (SF-36)|The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36): The SF-36 was designed to measure general health status. Two scales were used: Work Activities (four items) and General Health (one item). For the work activities scale, the reported score was the sum of four questions, each with values ranging from 1 to 4, the total score could range from 4 to 16. A higher score on Work Activities indicates more health-related problems For the general health question, the patients ranked their health from Excellent (1) to poor (5), the scale ranged from 1 to 5 with 1 being best health and 5 being worst. A high score in General Health indicates poorer health state.|baseline, 1-year||05/2018||||
798276|NCT00938964|Secondary|Change in Study 36-Item Short Form Health Survey (SF-36)|The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36): The SF-36 was designed to measure general health status. Two scales were used: Work Activities (four items) and General Health (one item). For the work activities scale, the reported score was the sum of four questions, each with values ranging from 1 to 4, the total score could range from 4 to 16. A higher score on Work Activities indicates more health-related problems For the general health question, the patients ranked their health from Excellent (1) to poor (5), the scale ranged from 1 to 5 with 1 being best health and 5 being worst. A high score in General Health indicates poorer health state.|baseline, 6-weeks|||units on a scale||Standard Deviation|Mean
798277|NCT00938964|Secondary|Change in Social Activity|Social Activity: This measure consisted of eight items that indicate the degree of social interaction. Sample items are “How often do you talk on the telephone with friends and relatives?” and “How often do you attend meetings of social groups, clubs, or civic organizations?” Scores range from 8 to 32. A lower score indicates more social activity.|baseline, 1-year||||||
798278|NCT00938964|Secondary|Change in Social Activity|Social Activity: This measure consisted of eight items that indicate the degree of social interaction. Sample items are “How often do you talk on the telephone with friends and relatives?” and “How often do you attend meetings of social groups, clubs, or civic organizations?” Scores range from 8 to 32. A lower score indicates more social activity.|baseline, 6-weeks|||units on a scale||Standard Deviation|Mean
798279|NCT00938964|Secondary|Change in Perceived Social Support|Perceived Social Support Scale: Twelve items indicate how strongly subjects agree that there is “a special person who is around when I am in need” and “my family really tries to help me.” Choices range from “very strongly disagree” to “very strongly agree.” Items are summed for a range of 12 to 84, with a high score meaning more social support.|baseline, 1-year||05/2018||||
798280|NCT00938964|Secondary|Change in Perceived Social Support|Perceived Social Support Scale: Twelve items indicate how strongly subjects agree that there is “a special person who is around when I am in need” and “my family really tries to help me.” Choices range from “very strongly disagree” to “very strongly agree.” Items are summed for a range of 12 to 84, with a high score meaning more social support.|baseline, 6-weeks|||units on a scale||Standard Deviation|Mean
798281|NCT00938964|Secondary|Change in the Cognitive Difficulties Scale|Cognitive Difficulties Scale: a 39-item scale, is a self-report assessment of perceived problems in long- and short-term memory, concentration, attention, and psycho-motor coordination. Sample items are “I forget errands I planned to do” and “I fail to recognize people I know.” Scores range from 39 to 164, with higher scores indicating greater cognitive difficulty.|baseline, 1-year||||||
798282|NCT00938964|Secondary|Change in the Cognitive Difficulties Scale|Cognitive Difficulties Scale: a 39-item scale, is a self-report assessment of perceived problems in long- and short-term memory, concentration, attention, and psycho-motor coordination. Sample items are “I forget errands I planned to do” and “I fail to recognize people I know.” Scores range from 39 to 164, with higher scores indicating greater cognitive difficulty.|baseline, 6-weeks|||units on a scale||Standard Deviation|Mean
798283|NCT00938964|Secondary|Change in the Duke Older Americans Resources and Services Procedures– Instrumental Activities of Daily Living (OARS-IADL)|Duke Older Americans Resources and Services Procedures– Instrumental Activities of Daily Living (OARS-IADL): This measure contains six items that assess the ability to perform important tasks for daily living (e.g., “Could you prepare your own meals?” “Could you drive a car?”). Scores range from 6 to 24. Higher scores indicate increasing difficulty in engaging in daily activities.|baseline, 1-year||||||
798284|NCT00938964|Secondary|Change in the Duke Older Americans Resources and Services Procedures– Instrumental Activities of Daily Living (OARS-IADL)|Duke Older Americans Resources and Services Procedures– Instrumental Activities of Daily Living (OARS-IADL): This measure contains six items that assess the ability to perform important tasks for daily living (e.g., “Could you prepare your own meals?” “Could you drive a car?”). Scores range from 6 to 24. Higher scores indicate increasing difficulty in engaging in daily activities.|baseline, 6-weeks|||units on a scale||Standard Deviation|Mean
798285|NCT00938964|Secondary|Change in Symptom Limitations|Symptom limitations: Patients were given a list of eight symptoms and asked to rate the degree to which the symptom limited daily activities. The symptoms were angina, shortness of breath, arthritis, back trouble, leg pains, headaches, fatigue, and other. Scores range from 8 to 32, with higher scores indicating greater limitations.|baseline, 1-year||||||
798286|NCT00938964|Secondary|Change in Symptom Limitations|Symptom limitations: Patients were given a list of eight symptoms and asked to rate the degree to which the symptom limited daily activities. The symptoms were angina, shortness of breath, arthritis, back trouble, leg pains, headaches, fatigue, and other. Scores range from 8 to 32, with higher scores indicating greater limitations.|baseline, 6-weeks|||units on a scale||Standard Deviation|Mean
798287|NCT00938964|Secondary|Change in Spielberger State Anxiety Inventory (STAI)|Spielberger State Anxiety Inventory (STAI): The STAI consists of two 20-item scales that measure anxiety. Representative items include statements such as “I feel nervous” and “I feel worried.” These items are rated on a 4-point scale, based on how well they describe the patient’s current or typical mood, from “not at all” to “very much so.” Scores range from 20 to 80, with higher scores indicating greater anxiety.|baseline, 1-year||||||
798288|NCT00938964|Secondary|Change in Spielberger State Anxiety Inventory (STAI)|Spielberger State Anxiety Inventory (STAI): The STAI consists of two 20-item scales that measure anxiety. Representative items include statements such as “I feel nervous” and “I feel worried.” These items are rated on a 4-point scale, based on how well they describe the patient’s current or typical mood, from “not at all” to “very much so.” Scores range from 20 to 80, with higher scores indicating greater anxiety.|baseline, 6-weeks|||units on a scale||Standard Deviation|Mean
798289|NCT00938964|Secondary|Change in Center for Epidemiological Studies Depression Scale (CES-D)|Center for Epidemiological Studies Depression Scale (CES-D). The CES-D is a 20-item self-report examination designed to measure symptoms of depression. Subjects rate the degree to which they have experienced a range of symptoms of depression, such as “I had crying spells” and “I felt lonely.” Scores range from 0 to 60, with higher scores indicating greater depressive symptoms. Scores greater than 16 are typically considered indicative of clinically significant depression.|baseline, 1-year||||||
798290|NCT00938964|Secondary|Change in Center for Epidemiological Studies Depression Scale (CES-D)|Center for Epidemiological Studies Depression Scale (CES-D). The CES-D is a 20-item self-report examination designed to measure symptoms of depression. Subjects rate the degree to which they have experienced a range of symptoms of depression, such as “I had crying spells” and “I felt lonely.” Scores range from 0 to 60, with higher scores indicating greater depressive symptoms. Scores greater than 16 are typically considered indicative of clinically significant depression.|baseline, 6-weeks|||units on a scale||Standard Deviation|Mean
798291|NCT00938964|Secondary|Change in Neurological Function, as Measured by the National Institutes of Health Stroke Scale (NIHSS)|The National Institutes of Health Stroke Scale (NIHSS) is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent’s ability to answer questions and perform activities. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items. The range of scores is from 0 (normal) to 42 (profound effect of stroke on patient).|baseline, 1-year||05/2018||||
798292|NCT00938964|Secondary|Change in Neurological Function, as Measured by the National Institutes of Health Stroke Scale (NIHSS)|The National Institutes of Health Stroke Scale (NIHSS) is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent’s ability to answer questions and perform activities. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items. The range of scores is from 0 (normal) to 42 (profound effect of stroke on patient).|baseline, 6-weeks|||units on a scale||Standard Deviation|Mean
798293|NCT00938964|Secondary|Change in Duke Activity Status Index (DASI)|The DASI is a 12-item scale of functional capacity that has been found to correlate well with objective measures of maximal exercise capacity. Items reflect activities of personal care, ambulation, household tasks, sexual function, and recreational activities. Activities done “with no difficulty” receive scores, which are weighted and summed, for a quantitative measure of functional status. Scores range from 0 to 60; a higher-weighted score indicates better function.|baseline, 1-year||||||
798294|NCT00938964|Secondary|Change in Duke Activity Status Index (DASI)|The DASI is a 12-item scale of functional capacity that has been found to correlate well with objective measures of maximal exercise capacity. Items reflect activities of personal care, ambulation, household tasks, sexual function, and recreational activities. Activities done “with no difficulty” receive scores, which are weighted and summed, for a quantitative measure of functional status. Scores range from 0 to 60; a higher-weighted score indicates better function.|baseline, 6-weeks|||units on a scale||Standard Deviation|Mean
798295|NCT00938964|Secondary|Change in Cognitive Function From Baseline||1 year after surgery||05/2018||||
798296|NCT00938964|Secondary|Transcerebral Activation Gradient of Platelet-neutrophil Conjugates|Paired jugular venous and radial arterial blood samples were drawn at baseline, cross-clamp removal, end of cardiopulmonary bypass, and 6 hours post cross-clamp removalime points and analyzed by fluorescence-activated cell sorting to identify activated platelets. Transcerebral activation gradients were calculated by subtracting arterial values from venous values and were compared between groups|Baseline to 6 hours post cross-clamp removal|Planned substudy, that was analyzed after 202 enrolled subjects.||Mean linear fluorescence intensity-MLFI||Standard Deviation|Mean
798297|NCT00938964|Secondary|Transcerebral Activation Gradients of Monocytes|Paired jugular venous and radial arterial blood samples were drawn at baseline, cross-clamp removal, end of cardiopulmonary bypass, and 6 hours post cross-clamp removalime points and analyzed by fluorescence-activated cell sorting to identify activated platelets. Transcerebral activation gradients were calculated by subtracting arterial values from venous values and were compared between groups|Baseline to 6 hours post cross-clamp removal|Planned substudy, that was analyzed after 202 enrolled subjects.||Mean linear fluorescence intensity-MLFI||Standard Deviation|Mean
798298|NCT00938964|Secondary|Transcerebral Activation Gradients of Neutrophils|Paired jugular venous and radial arterial blood samples were drawn at baseline, cross-clamp removal, end of cardiopulmonary bypass, and 6 hours post cross-clamp removal and analyzed by fluorescence-activated cell sorting to identify activated platelets. Transcerebral activation gradients were calculated by subtracting arterial values from venous values and were compared between groups|Baseline to 6 hours post cross-clamp removal|Planned substudy, that was analyzed after 202 enrolled subjects||Mean linear fluorescence intensity-MLFI||Standard Deviation|Mean
798299|NCT00938964|Secondary|Transcerebral Activation Gradients of Platelets|Paired jugular venous and radial arterial blood samples were drawn at baseline, cross-clamp removal, end of cardiopulmonary bypass, and 6 hours post cross-clamp removalime points and analyzed by fluorescence-activated cell sorting to identify activated platelets. Transcerebral activation gradients were calculated by subtracting arterial values from venous values and were compared between groups|Baseline to 6 hours post cross-clamp removal|Planned substudy, that was analyzed after 202 enrolled subjects||Mean linear fluorescence intensity-MLFI||Standard Deviation|Mean
798300|NCT00938964|Primary|Count of Participants With a Decline of Greater Than or Equal to One Standard Deviation in One or More of Five Cognitive Domain Scores Reported as a Dichotomous Post-operative Cognitive Deficit (POCD) Outcome|To characterize cognitive function over time, while minimizing potential redundancy in the cognitive measures, a factor analysis was performed on the 14 cognitive test scores from baseline. We chose a five-factor solution, which represents 5 cognitive domains: structured verbal memory, unstructured verbal memory, executive function, visual memory and attention/concentration. Each domain score is normally distributed with a mean of zero. A change score was calculated for each domain by subtracting the baseline from the 6-week score. A dichotomous outcome variable of post-operative cognitive deficit was defined as a decline of ≥1 standard deviation in 1 or more of the 5 domains.|Preoperative to 6 weeks after surgery|||Participants|||Count of Participants
798301|NCT00938964|Primary|Change in Cognitive Function From Baseline Characterized as Continuous Cognitive Change|To characterize cognitive function over time, while minimizing potential redundancy in the cognitive measures, a factor analysis was performed on the 14 cognitive test scores from baseline. We chose a five-factor solution, which represents 5 cognitive domains: structured verbal memory, unstructured verbal memory, executive function, visual memory and attention/concentration. To quantify overall cognitive function, a baseline cognitive index was first calculated as the mean of the 5 preoperative domain scores. The cognitive index score has a mean of zero, thus any positive score is above the mean, any negative score is below the mean. A continuous change score was then calculated by subtracting the baseline from the 6-week cognitive index. The resulting outcome measure is unbounded with standard deviation of 0.35. A negative change score indicating decline and a positive score indicating improvement.|Preoperative to 6 weeks after surgery|||units on a scale||Standard Deviation|Mean
798302|NCT00939003|Other Pre-specified|Number of Participants Achieving a BASDAI50 Response During the Open-label Period|The Bath Ankylosing Spondylitis (AS) Disease Activity Index assesses disease activity by asking the participant to answer 6 questions (each on a 10 cm VAS) pertaining to symptoms experienced for the past week. For 5 questions (level of fatigue/tiredness, level of AS neck, back or hip pain, level of pain/swelling in joints, other than neck, back or hips, level of discomfort from any areas tender to touch or pressure, and level of morning stiffness), the response is from 0 (none) to 10 (very severe); for Question 6 (duration of morning stiffness), the response is from 0 (0 hours) to 10 (≥ 2 hours). The overall BASDAI score ranges from 0 to 10 cm. Lower scores indicate less disease activity. BASDAI50 is a 50% improvement from Baseline in BASDAI score.|Baseline and Weeks 52, 104, and 156|Full analysis set participants with available data at each time point (indicated by N)||participants|||Number
798303|NCT00939003|Other Pre-specified|Number of Participants Achieving an ASAS40 Response During the Open-label Period|"ASAS40 response was defined as improvement of ≥ 40% relative to Baseline and absolute improvement of ≥ 20 units (on a scale from 0 to 100) in ≥ 3 of the following 4 domains with no deterioration (defined as a net worsening of > 0 units on a scale of 0 to 100) in the potential remaining domain:
Patient's Global Assessment of disease activity, measured on a visual analog scale (VAS) from 0 (none) to 100 (severe);
Pain, measured by the total back pain VAS from 0 (no pain) to 100 (most severe);
Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on a VAS ranging from 0 (easy) to 100 (impossible);
Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) VAS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration)."|Baseline and Weeks 52, 104, and 156|Full analysis set participants with available data at each time point (indicated by N)||participants|||Number
798304|NCT00939003|Other Pre-specified|Number of Participants Achieving an ASAS20 Response During the Open-label Period|"ASAS20 response was defined as improvement of ≥ 20% relative to Baseline and absolute improvement of ≥ 10 units (on a scale from 0 to 100) in ≥ 3 of the following 4 domains with no deterioration (defined as a change for the worse of ≥ 20% and net worsening of ≥ 10 units) in the potential remaining domain:
Patient's Global Assessment of disease activity, measured on a visual analog scale (VAS) from 0 (none) to 100 (severe);
Pain, measured by the total back pain VAS from 0 (no pain) to 100 (most severe);
Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on a VAS ranging from 0 (easy) to 100 (impossible);
Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) VAS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration)."|Baseline and Weeks 52, 104, and 156|Full analysis set participants with available data at each time point (as indicated by N)||participants|||Number
798305|NCT00939003|Secondary|Change From Baseline in SPARCC MRI Score for the Spine|"Six discovertebral units (DVU) representing the 6 most abnormal DVUs, and 3 consecutive sagittal slices at each DVU representing the most abnormal slices for that DVU were selected for scoring. Each DVU was divided into 4 quadrants and scored for the presence (1) or absence (0) of edema. The maximum score is 12 per DVU. The maximum score is 72 for 6 DVUs.
If edema was present in at least 1 quadrant of a DVU slice, it was scored for intensity and depth of the edema representing that slice:
A score of 1 was assigned if an intense signal was seen in any quadrant on a DVU slice. The maximum score for intensity per slice is 1, per DVU is 3 and for 6 DVUs is 18.
A lesion was graded as deep (score of 1) if there was homogeneous and unequivocal increase in signal extending over a depth of at least 1 cm from the surface of the endplate in any quadrant. The maximum score per slice is 1, for a DVU is 3 and for 6 DVUs is 18.
The total maximum SPARCC score for all 6 DVUs is 108."|Baseline and Week 12|Full analysis set; participants with non-missing Baseline and non-missing post-baseline value were included.||units on a scale||Standard Deviation|Mean
798306|NCT00939003|Secondary|Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Score for Sacroiliac Joints|"Six consecutive sacroiliac (SI) joint image coronal slices representing the largest proportion of the synovial compartment of the SI joints were assessed for edema, intensity and depth of edema using SPARCC scoring.
Each SI joint (left and right) was divided into quadrants for a total of 8 SI scoring locations. Each quadrant was scored for the presence (1) or absence (0) of edema; the maximum score is 8 per slice and maximum score for 6 SI joint slices is 48.
Intensity of edema: A score of 1 was assigned for each SI joint (left and right) if an intense signal was seen in any quadrant of that joint for each slice. The maximum score is 2 per slice and 12 for 6 slices.
A lesion was graded as deep (score of 1) if there was homogeneous and unequivocal increase in signal extending over a depth of at least 1 cm from the articular surface of the SI joint in any quadrant. The maximum score per slice is 2 and for 6 slices 12.
The total maximum score for all SI joints across 6 slices is 72."|Baseline and Week 12|Full analysis set; participants with non-missing Baseline and non-missing post-baseline value were included.||units on a scale||Standard Deviation|Mean
798307|NCT00939003|Secondary|Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP)|C-reactive protein (CRP) is considered an efficacy variable for the axial spondyloarthritis indication. It is a general marker of inflammation that is sensitive to acute changes in inflammatory response. Higher levels indicate more inflammation.|Baseline and Week 12|Full analysis set; participants with non-missing Baseline and at least one non-missing post-baseline value were included. Last observation carried forward was used.||mg/L||Standard Deviation|Mean
798308|NCT00939003|Secondary|Change From Baseline in Disability Index of Health Assessment Questionnaire Modified for the Spondyloarthropathies (HAQ-S)|Health Assessment Questionnaire modified for spondyloarthropathies (HAQ-S) is a self-reported measure to assess the physical function and health-related quality of life. The Disability Index (DI) of HAQ-S is calculated as the mean of the following 8 category scores (range: 0 [without any difficulty] to 3 [unable to do]): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Five additional items in the functional status measure were included in the HAQ-S, including carrying heavy packages, sitting for long periods, able to work at a flat topped table, and (if the participant had a driver's license or a car) able to look in the rear view mirror and able to turn head to drive in reverse. The overall score ranges from 0 (no disability) to 3 (three very severe, high-dependency disability). Negative mean changes from Baseline in the overall score indicate improvement.|Baseline and Week 12|Full analysis set; participants with non-missing Baseline and at least one non-missing post-baseline values were included. Last observation carried forward was used.||units on a scale||Standard Deviation|Mean
798309|NCT00939003|Secondary|Number of Participants Achieving an ASAS5/6 Response|"ASAS5/6 response is a 20% improvement in five out of the following six domains:
Patient's Global Assessment of disease activity, measured on a visual analog scale (VAS) from 0 (none) to 100 (severe);
Pain, measured by the total back pain VAS from 0 (no pain) to 100 (most severe);
Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on a VAS ranging from 0 (easy) to 100 (impossible);
Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) VAS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none) to 10 (very severe/2 hours or more duration).
Spinal mobility, measured from the lateral lumbar flexion score of the Bath AS Metrology Index (BASMI) on a scale from 0 (best mobility) to 10 (worst mobility);
C-reactive protein level (lower levels indicate less inflammation)."|Baseline and Week 12|Full analysis set; Non-responder imputation performed.||participants|||Number
798310|NCT00939003|Other Pre-specified|Number of Participants With Blood Hematology or Chemistry Values Common Toxicity Criteria Grade ≥ 3|Blood was collected for analysis at designated study visits; hematology and chemistry results were provided by a central laboratory. The number of participants with an abnormal laboratory result (higher then upper normal limit or lower than lower normal limit) meeting Common Toxicity Criteria (CTC) of Grade 3 or higher is summarized.|Through Week 12|All participants who received at least 1 dose of study drug. Results for the double-blind phase phase of the study are reported through Week 12.||participants|||Number
798311|NCT00939003|Other Pre-specified|Number of Participants Reporting Adverse Events|Adverse events were collected at designated study visits for all participants who received at least 1 dose of study drug. The number of participants experiencing any adverse event (serious and non-serious) is summarized.|Through Week 12|All participants who received at least 1 dose of study drug. For the double-blind phase of the study, adverse events are reported through Week 12.||participants|||Number
798312|NCT00939003|Secondary|Number of Participants Achieving ASAS Partial Remission|"ASAS partial remission is an absolute score of < 20 units on a 0 to 100 scale for each of the four following domains:
Patient's Global Assessment of disease activity, measured on a visual analog scale (VAS) from 0 (none) to 100 (severe);
Pain, measured by the total back pain VAS from 0 (no pain) to 100 (most severe);
Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on a VAS ranging from 0 (easy) to 100 (impossible);
Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) VAS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration)."|Week 12|Full analysis set; Non-responder imputation performed.||participants|||Number
798313|NCT00939003|Secondary|Change From Baseline in Short Form-36 (SF-36) Physical Component Summary Score|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life. The SF-36 consists of 36 questions in 8 domains (limitations in physical functioning due to health problems; limitations in usual role because of physical health problems; bodily pain; general health perceptions; vitality; limitations in social functioning because of physical or emotional problems; limitations in usual role due to emotional problems; and general mental health). Two component scores can be summarized: physical and mental; domains 1-4 comprise the physical component summary of the SF-36. A transformed summary score is calculated ranging from 0 to 100 where higher scores indicate a higher level of functioning. A positive change from Baseline score indicates an improvement.|Baseline and Week 12|Full analysis set with available data||units on a scale||Standard Deviation|Mean
798314|NCT00939003|Secondary|Number of Participants Achieving a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response|The Bath Ankylosing Spondylitis (AS) Disease Activity Index assesses disease activity by asking the participant to answer 6 questions (each on a 10 cm VAS) pertaining to symptoms experienced for the past week. For 5 questions (level of fatigue/tiredness, level of AS neck, back or hip pain, level of pain/swelling in joints, other than neck, back or hips, level of discomfort from any areas tender to touch or pressure, and level of morning stiffness), the response is from 0 (none) to 10 (very severe); for Question 6 (duration of morning stiffness), the response is from 0 (0 hours) to 10 (≥ 2 hours). The overall BASDAI score ranges from 0 to 10 cm. Lower scores indicate less disease activity. BASDAI50 is a 50% improvement from Baseline in BASDAI score.|Baseline and Week 12|Full analysis set; Non-responder imputation performed.||participants|||Number
798315|NCT00939003|Secondary|Number of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) 20 Response|"ASAS20 response was defined as improvement of ≥ 20% relative to Baseline and absolute improvement of ≥ 10 units (on a scale from 0 to 100) in ≥ 3 of the following 4 domains with no deterioration (defined as a change for the worse of ≥ 20% and net worsening of ≥ 10 units) in the potential remaining domain:
Patient's Global Assessment of disease activity, measured on a visual analog scale (VAS) from 0 (none) to 100 (severe);
Pain, measured by the total back pain VAS from 0 (no pain) to 100 (most severe);
Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants’ ability to perform activities on a VAS ranging from 0 (easy) to 100 (impossible);
Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) VAS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration)."|Baseline and Week 12|Full analysis set; Non-responder imputation performed.||participants|||Number
798316|NCT00939003|Primary|Number of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) 40 Response|"ASAS40 response was defined as improvement of ≥ 40% relative to Baseline and absolute improvement of ≥ 20 units (on a scale from 0 to 100) in ≥ 3 of the following 4 domains with no deterioration (defined as a net worsening of > 0 units on a scale from 0 to 100) in the potential remaining domain:
Patient's Global Assessment of disease activity, measured on a visual analog scale (VAS) from 0 (none) to 100 (severe);
Pain, measured by the total back pain VAS from 0 (no pain) to 100 (most severe);
Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants’ ability to perform activities on a VAS ranging from 0 (easy) to 100 (impossible);
Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) VAS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration)."|Baseline and Week 12|Full analysis set. Participants with missing data at Week 12 were counted as non-responders (non-responder imputation).||participants|||Number
798317|NCT00939029|Secondary|Point-prevalence Abstinence at 6 Months|7 day point prevalence abstinence from all tobacco at 6 months, biochemically confirmed using urinary anabasine < 2 ng per ml.|week 24|intention to treat||participants|||Number
798318|NCT00939029|Secondary|Point-prevalence Abstinence at 3 Months|7 day point prevalence abstinence from tobacco at 3 months, biochemically confirmed using urinary anabasine < 2 ng per ml|week 12|intention to treat||participants|||Number
798319|NCT00939029|Primary|End of Treatment (Week 8) Point Prevalence Abstinence|7 day point prevalence abstinence at the end of treatment, biochemically confirmed by urinary anabasine < 2 ng per ml|weeks 8|intention to treat||participants|||Number
798320|NCT00939055|Secondary|Quality of Life|Quality of life as assessed by the Impact of Weight on Quality of Life Questionnaire (IWQOL-Lite); a ≥ 10 total score improvement from baseline (screening) will represent a clinically significant improvement.|12 months|Secondary endpoint was not analyzed.|||||
798321|NCT00939055|Primary|Weight Loss|A clinically significant reduction in pre-RNYGB excess weight, defined by ≥15% EBL and BMI < 35.|12 month|When futility analysis was performed, only 46 out of 108 patients had reached the 12 month primary endpoint. Analysis was performed on the 29 StomaphyX-treated patients to determine whether study objectives were met. Sham (control) patients were not analyzed.||participants|||Number
798322|NCT00939094|Secondary|Change in BPI-SF Pain Interference From Baseline to Day 28|Change from baseline (measured prior to randomization) to Day 28 was calculated for pain interference (mean of 7 interference items). Each interference item is recorded on a NRS 0-10, where 0=No interference and 10=Interferes completely.|28 days|||Scores on BPI-SF pain interference||Standard Error|Least Squares Mean
798323|NCT00939094|Secondary|Change in Brief Pain Inventory-Short Form (BPI-SF) Pain Severity From Baseline to Day 28|Change from baseline (measured prior to randomization) to Day 28 was calculated for the pain severity (mean of 4 intensity items). Each intensity item is recorded on a NRS 0-10, where 0=No Pain and 10=Pain as bad as you can imagine.|28 days|||Scores (units) on BPI-SF pain severity||Standard Error|Least Squares Mean
798324|NCT00939094|Secondary|Change in SF-MPQ Affective Index From Baseline to Day 28|"Affective index=sum of the intensity scale values of the words chosen for the descriptors 12-15 in the questionnaire. Range of scores for the affective index=0-12 (higher score represents a worse condition).
Change from baseline (measured prior to randomization) to Day 28 was calculated."|28 days|||Scores (units) on SF-MPQ Affective Index||Standard Deviation|Least Squares Mean
798325|NCT00939094|Secondary|Change in Short Form McGill Pain Questionnaire (SF-MPQ) Sensory Index From Baseline to Day 28|"Sensory index=sum of the intensity scale values of the words chosen for the descriptors 1-11 in the questionnaire. Range of scores for the sensory index=0-33 (higher score represents a worse condition).
Change from baseline (measured prior to randomization) to Day 28 was calculated."|28 days|||Scores (units) on SF-MPQ Sensory Index||Standard Error|Least Squares Mean
798326|NCT00939094|Secondary|Patients With Patient Global Impression of Change (PGIC) Score of at Least “Much Improved” (Responder Rate) at Day 28|"PGIC scale ranges from 1-7 where 1=Very much improved and 7=Very much worse Responder=Patient with a response of  much improved or very much improved Responder rate=(no. of responders/total no. of patients)*100"|28 days|||Patients|||Number
798327|NCT00939094|Secondary|Patients With ≥50% Reduction From Baseline in NRS Pain Intensity Score (Responder Rate) at Day 28|Pain intensity score reduction=(change from baseline Day 28/baseline)*100 Responder=pain intensity score reduction ≥50% (Yes/No)? Responder rate=(no. of responders/total no. of patients)*100|28 days|||Participants|||Number
798328|NCT00939094|Secondary|Patients With ≥30% Reduction From Baseline in NRS Pain Intensity Score (Responder Rate) at Day 28|NRS pain intensity score reduction=(change from baseline at Day 28/baseline)*100 Responder=pain intensity score reduction ≥30% (yes/no)? Responder rate=(no. of responders/total no. of patients)*100|28 days|||Participants|||Number
798329|NCT00939094|Primary|Change in Mean Numerical Rating Scale (NRS) Pain Score From Baseline to Last 5 Days on Treatment|Mean pain intensity for 5-day baseline period (morning Day -5 to evening Day-1) and mean pain intensity for last 5 days on treatment (ie, last dose day and the 4 preceding calendar days) was calculated based on the NRS scale (0-10). 0=No pain, 10=Worst pain imaginable.|Change in mean pain intensity from 5-day baseline to the last 5 days on treatment, measure twice daily with NRS (12-hour recall)|||Scores (units) on NRS||Standard Error|Least Squares Mean
798330|NCT00939107|Primary|Number of Patients With Treatment Success|Treatment success was defined as a reduction of at least 5 points or an absolute score below 5 points on the 23-item modified Roland Morris Disability Questionnaire (best value: 0 points, worst value 23 points)|Two months posttreatment|Intention to treat||participants|||Number
798331|NCT00939107|Secondary|Cost Effectiveness||twelve months posttreatment||08/2010||||
798332|NCT00939107|Secondary|Quality of Life|Quality of life, general health, measured on the Short Form 36 questionnaire (worst:100, best:0)|twelve months posttreatment||08/2010||||
798333|NCT00939107|Secondary|Number of Patients on Sick Leave|Measured by self-report of beeing on sick leave at the moment because of LBP|twelve months posttreatment|Number of patients on sick leave due to LBP pre-treatment.||Participants|||Number
798351|NCT00939211|Secondary|Plasma AZD9164 Cmax|Maximum plasma concentration of AZD9164|0, 5 min, 15 min, 30 min, 60 min, 90 min, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h|||nmol/L||Full Range|Geometric Mean
798352|NCT00939211|Secondary|QTcF, Average Effect Over 0 - 4 Hours Post-dose|Average QTcF value|0, 30 min, 2 h, 4 h|||ms||Standard Deviation|Mean
798336|NCT00939120|Secondary|International Prostate Symptoms Score (IPSS), Storage Subscore|To evaluate the efficacy in men taking dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with LUTS including OAB symptoms: storage subscore international prostate symptoms score (IPSS) - 3 questions scored from 0-5 (higher score indicating more severe symptoms), thus total scores ranged from 0-15.|12 months|Last data point carried forward for participants who were randomized and dropped prior to study end.||units on a scale||Standard Error|Mean
798337|NCT00939120|Secondary|International Prostate Symptoms Score, Voiding Subscore|To evaluate the efficacy in men taking dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with LUTS including OAB symptoms: voiding subscore of international prostate symptoms score (IPSS) - 4 questions scored from 0-5 (higher score indicating more severe symptoms), thus total scores ranged from 0-20.|12 months|Last data point carried forward for participants who were randomized and dropped prior to study end.||units on a scale||Standard Error|Mean
798338|NCT00939120|Secondary|International Prostate Symptoms Score (IPSS), Total|To evaluate the efficacy in men taking dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with LUTS including OAB symptoms: total international prostate symptoms score (IPSS) - 7 questions scored from 0-5 (higher score indicating more severe symptoms), thus total scores ranged from 0-35.|12 months|Last data point carried forward for participants who were randomized and dropped prior to study end.||units on a scale||Standard Error|Mean
798339|NCT00939120|Secondary|Patient Perception of Bladder Condition (PPBC)|To evaluate the efficacy in men taking dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with LUTS including OAB symptoms: participant reported patient perception of bladder condition (PPBC), one question scored from 1-6, higher scores indicating more severe symptoms.|12 months|Last data point carried forward for participants who were randomized and dropped prior to study end.||units on a scale||Standard Error|Mean
798340|NCT00939120|Primary|Acute Urinary Retention (AUR)|To evaluate the safety of dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with symptoms of LUTS: acute urinary attention (AUR) - inability to urinate requiring catheterization.|12 months|Last data point carried forward for participants who were randomized and dropped prior to study end.||participants|||Number
798341|NCT00939120|Primary|Urine Voided Volume (Voiding)|To evaluate the safety of dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with symptoms of LUTS: urine voided volume (voiding) measured by uroflowmetry.|12 months|Last data point carried forward for participants who were randomized and dropped prior to study end.||mL||Standard Error|Mean
798342|NCT00939120|Primary|Maximum Urine Flow Rate (Qmax).|To evaluate the safety of dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with symptoms of LUTS: maximum urine flow rate (Qmax) measured via uroflowmetry.|12 months|Last data point carried forward for participants who were randomized and dropped prior to study end.||mL/sec||Standard Error|Mean
798343|NCT00939120|Secondary|Overactive Bladder Questionnaire (OABq)|To evaluate the efficacy in men taking dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with LUTS including OAB symptoms: overactive bladder questionnaire (OABq) - 33 questions scored via 1-6 (higher scores indicate more severe symptoms), thus values ranged from 33-198.|12 months|Last data point carried forward for participants who were randomized and dropped prior to study end.||units on a scale||Standard Error|Mean
798344|NCT00939120|Primary|Post-void Residual (PVR) Volume|To evaluate the safety of dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with symptoms of LUTS: post-voiding residual volume measured via ultrasound.|12 months|Last data point carried forward for participants who were randomized and dropped prior to study end.||mL||Standard Error|Mean
798345|NCT00939159|Primary|Overall Response Rate Based on the Hematologic Improvement|"Overall response rate defined by International Working Group (IWG) response criteria in myelodysplasia. Hematologic Improvement (HI) responses, at least 9 weeks: Erythroid response (pretreatment, <11 g/dL): Hgb increase by 1.5 g/dL; Relevant reduction units of Red blood cell (RBC) transfusions by absolute number at least 4 RBC transfusions/8 week compared with pretreatment transfusion number in previous 8 weeks; Only RBC transfusions for Hgb of 9.0 g/dL pretreatment count in RBC transfusion response evaluation; Platelet response (pretreatment,<100x10^9/L): If starting with >20x10^9/L platelets:
absolute increase 30x10^9/L, Increase from baseline <20 x10^9/L to >20x10^9/L and by =/> 100%; Neutrophil response (pretreatment, <1.0x10^9/L): =/> 100% increase & absolute increase >0.5x10^9/L; Progression or relapse after HI: At least 1 of the following: =/>50% decrement from max response levels in granulocytes or platelets; Reduction in Hgb by 1.5 g/dL; or Transfusion dependence ."|Assessment with 28-day cycle until response, then every 3 cycles as needed|Of the seventeen participants registered, four were not treated making thirteen evaluable for response.||Percentage of Participants|||Number
798346|NCT00939185|Secondary|Time Reported for a Patient Being Consulted and Diagnosed From the Moment He/She Entered the Hospital|Time of exam completion minus the start time of the examination.|Day 1|Safety population||minutes||Full Range|Median
798347|NCT00939185|Secondary|Compliance|"Compliance was assessed by the following questions: Question 1: Were the pediatrician’s instructions during the treatment phase followed (i.e. dose, frequency and number of days)?; Question 2: Was it easy to understand your pediatrician's instructions regarding treatment?; and Question 3: Was the administration of this drug easier than any other previously used drug? Patients could answer either yes, no, or Not applicable (NA)."|3 to 7 days after receiving treatment|Safety population||participants|||Number
798348|NCT00939185|Secondary|Number of Subjects Who Withdrew From the Study||3 to 7 days after receiving treatment|Safety Population. Please refer to the participant flow and AE sections for results pertaining to tolerability.||participants|||Number
798349|NCT00939185|Primary|Number of Patients With Adverse Events (AEs)|All observed or volunteered AEs regardless of suspected causal relationship to the investigational product(s) were reported.|3 to 7 days after receiving treatment|Safety population = Those subjects who were known to have received at least one dose of the study treatment. Subjects who were dispensed study treatment and immediately lost to follow-up were not included among those known to have been dosed.||participants|||Number
798350|NCT00939211|Secondary|Plasma AZD9164 AUC0-24|Area under the AZD9164 plasma concentration curve|0, 5 min, 15 min, 30 min, 60 min, 90 min, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h|||nmol*h/L||Full Range|Geometric Mean
798361|NCT00939341|Secondary|Study Medication Use (Maintenance and Reliever) in Diary Cards – Percentage of Days During Treatment Period Participants Used ≥ 9 Inhalations of Symbicort® 160µg/4.5µg in a Day|The mean percentage of days during treatment period participants used ≥ 9 inhalations of Symbicort® 160µg/4.5µg in a day|Baseline and 12 weeks|||Percentage of days||Standard Deviation|Mean
798362|NCT00939341|Secondary|Study Medication Use (Maintenance and Reliever) in Diary Cards – Percentage of Days During Treatment Period Participants Used ≥ 5 Inhalations of of Symbicort® 160µg/4.5µg in a Day|The mean percentage of days during treatment period participants used ≥ 5 inhalations of Symbicort® 160µg/4.5µg in a day|Baseline and 12 weeks|||Percentage of days||Standard Deviation|Mean
798363|NCT00939341|Secondary|Study Medication Use (Maintenance and Reliever) in Diary Cards – Percentage of Days During Treatment Period Participants Used ≥ 3 Inhalations of Symbicort® 160µg/4.5µg in a Day|The mean percentage of days during treatment period participants used ≥ 3 inhalations of Symbicort® 160µg/4.5µg in a day|Baseline and 12 weeks|||Percentage of days||Standard Deviation|Mean
798364|NCT00939341|Secondary|Study Medication Use (Maintenance and Reliever) in Diary Cards – Total Number of Inhalations of Symbicort® 160µg/4.5µg Per Day During Treatment Period|Total number of inhalations of Symbicort® 160µg/4.5µg per day during treatment period, defined as the sum of maintenance medication and as-needed medication during night and day time|Baseline and 12 weeks|||Number of inhalations||Standard Deviation|Mean
798365|NCT00939341|Secondary|Study Medication Use (Maintenance and Reliever) in Diary Cards – Change in As-needed Night-time Reliever Medication From run-in Period|Change in the number of as-needed night-time inhalations of medication, calculated as difference in mean value of all available data obtained during treatment period and mean value in run-in period.|Baseline and 12 weeks|||Number of inhalations||95% Confidence Interval|Mean
798366|NCT00939341|Secondary|Study Medication Use (Maintenance and Reliever) in Diary Cards – Change in As-needed Day-time Reliever Medication From run-in Period|Change in the number of as-needed day-time inhalations of medication, defined as the difference in mean value of all available data obtained during treatment period and mean value in run-in period.|Baseline and 12 weeks|||Number of inhalations||95% Confidence Interval|Mean
798367|NCT00939341|Secondary|Change in AQLQ (S) Domain (Environmental Stimuli) Scores From Baseline|Participants ' responses to environmental stimuli were scored on a scale of decreasing response to environmental stimuli from 1 to 7, in which 1 = maximum response. The change in overall mean AQLQ(S) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12)|Baseline and 12 weeks|||Units on a scale||95% Confidence Interval|Mean
798368|NCT00939341|Secondary|Change in AQLQ (S) Domain (Emotion Function) Scores From Baseline|Participants' emotional functions were scored on a scale of decreasing impairment to emotional function from 1 to 7, in which 1 = maximum impairment. The change in overall mean AQLQ(S) emotion function score were calculated as change from baseline (Week 0) to the treatment period (mean of the scores at Week 4, Week 8, Week 12)|Baseline and 12 weeks|||Units on a scale||95% Confidence Interval|Mean
798369|NCT00939341|Secondary|Change in AQLQ (S) Domain (Activity Limitation) Scores From Baseline|Participants' QOL were scored on a scale of decreasing QOL impairment from 1 to 7, in which 1 = maximum impairment. The change in overall mean AQLQ(S) symptom score from baseline were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12)|Baseline and 12 weeks|||Units on a scale||95% Confidence Interval|Mean
798370|NCT00939341|Secondary|Change in AQLQ (S) Domain (Symptom) Scores From Baseline|Participants' QOL were scored on a scale of decreasing QOL impairment from 1 to 7, in which 1 = maximum impairment. The change in overall mean AQLQ(S) symptom score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12).|Baseline and 12 weeks|||Units on a scale||95% Confidence Interval|Mean
798371|NCT00939341|Secondary|Change in Asthma Quality of Life Questionnaire, Standardized Version (AQLQ (S)) Overall Scores From Baseline|Participants' QOL were scored on a scale of decreasing QOL impairment from 1 to 7, in which 1 = maximum impairment. The change in overall mean AQLQ(S) score from baseline were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12)|Baseline and 12 weeks|||Units on a scale||95% Confidence Interval|Mean
798372|NCT00939341|Secondary|Change in Overall ACQ(5) Score From Baseline at Country Level (Thailand)|Participants' levels of asthma control were scored on a 7-point Likert scale from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The regional mean change of overall ACQ(5) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12).|Baseline and 12 weeks|This outcome measure is reported at individual country level only, and therefore the number of patients analyzed are less than reported in participant flow, which captures the total patients in the region.||Units on a scale||95% Confidence Interval|Mean
798373|NCT00939341|Secondary|Change in Overall ACQ(5) Score From Baseline at Country Level (Taiwan)|Participants' levels of asthma control were scored on a 7-point Likert scale from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The regional mean change of overall ACQ(5) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12).|Baseline and 12 weeks|This outcome measure is reported at individual country level only, and therefore the number of patients analyzed are less than reported in participant flow, which captures the total patients in the region.||Units on a scale||95% Confidence Interval|Mean
798374|NCT00939341|Secondary|Change in Overall ACQ(5) Score From Baseline at Country Level (Indonesia)|Participants' levels of asthma control were scored on a 7-point Likert scale from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The regional mean change of overall ACQ(5) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12).|Baseline and 12 weeks|This outcome measure is reported at individual country level only, and therefore the number of patients analyzed are less than reported in participant flow, which captures the total patients in the region.||Units on a scale||95% Confidence Interval|Mean
798375|NCT00939341|Secondary|Change in Overall ACQ(5) Score From Baseline at Country Level (India)|Participants' levels of asthma control were scored on a 7-point Likert scale from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The regional mean change of overall ACQ(5) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12).|Baseline and 12 weeks|This outcome measure is reported at individual country level only, and therefore the number of patients analyzed are less than reported in participant flow, which captures the total patients in the region.||Units on a scale||95% Confidence Interval|Mean
798376|NCT00939341|Secondary|Change in ACQ(5) Score From Baseline at Country Level (China)|Participants' levels of asthma control were scored on a 7-point Likert scale from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The regional mean change of overall ACQ(5) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12).|Baseline and 12 weeks|This outcome measure is reported at individual country level only, and therefore the number of patients analyzed are less than reported in participant flow, which captures the total patients in the region.||Units on a scale||95% Confidence Interval|Mean
798377|NCT00939341|Primary|Change in Asthma Control Questionnaire (ACQ(5)) Score From Baseline at a Regional Level|Participants' levels of asthma control were scored on a 7-point Likert scale from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The regional mean change of overall ACQ(5) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12).|Baseline and 12 weeks|||Units on a scale||95% Confidence Interval|Mean
798378|NCT00939367|Primary|The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞)|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|plasma samples were obtained from blood drawn at 0 (within 60 minutes prior to dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 20 and 24 hours (18 samples) after administration of the dose.|||ng.hr/mL||Standard Deviation|Mean
798379|NCT00939367|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t)|plasma samples were obtained from blood drawn at 0 (within 60 minutes prior to dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 20 and 24 hours (18 samples) after administration of the dose.|||ng.hr/mL||Standard Deviation|Mean
798380|NCT00939367|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that the drug reaches in the plasma|plasma samples were obtained from blood drawn at 0 (within 60 minutes prior to dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 20 and 24 hours (18 samples) after administration of the dose.|||ng/mL||Standard Deviation|Mean
798391|NCT00939471|Primary|Effectiveness: Change in Sinus Symptom Scores (SNOT-20)|Change in sinus symptoms (mean reduction) for subjects 12 years of age or greater evaluated using the SNOT-20 questionnaire at 52 weeks post-procedure compared to baseline. The maximum possible score for the SNOT-20 is five and the minimum is zero. A reduction is SNOT-20 score indicates improvement.|12 months|Data calculated for matched pairs (subjects with baseline and 12 months follow-up scores).||change in SNOT-20 score||Standard Deviation|Mean
798392|NCT00939471|Secondary|Revision Rate|The number of subjects requiring revisions out of 33 subjects treated.|at 1 year|||participants|||Number
798393|NCT00939471|Secondary|Days Out of School During the 12 Months of Follow-up|Quantitative assessment of days out of school during the 12 months of follow-up.|12 months|||days||Standard Deviation|Mean
798394|NCT00939471|Secondary|Effectiveness of Dilation/Measured by Post-op Interventions|Effectiveness of balloon dilation as measured by the need for post-operative interventions other than revision sinus surgery. This endpoint evaluation includes irrigation and debridement. Number of post-operative interventions reported.|12 months|||number of interventions|||Number
798395|NCT00939471|Secondary|Effectiveness: Medication Thru 1 yr|Data was summarized from the Global Patient Assessment Form. Each subject's last observation was used in order to account for any missing data or early termination of subjects. The results indicated represents the proportion of subjects (expressed as a percentage) who reported a decrease in medication usage at the time of their study discontinuation.|12 months|||percentage of participants|||Number
798396|NCT00939471|Secondary|Device Success: Ability to Access/Dilate Sinus Ostia|Percentage of sinuses treated which were considered procedure success by the investigator relative to sinuses attempted.|12 months|intent to treat analysis||percentage of sinuses successful|sinuses||Number
798397|NCT00939471|Primary|Effectiveness: Change in Sinus Symptom Scores (SN-5)|Change in sinus symptoms (mean reduction) for subjects less than 12 years of age evaluated using the SN-5 questionnaire at 52 weeks post-procedure compared to baseline. The maximum possible score for the SN-5 is seven and the minimum is one. A reduction in SN-5 score indicates improvement.|12 months|Data calculated for matched pairs (subjects with baseline and 12 months follow-up scores).||change in SN-5 score||Standard Deviation|Mean
798398|NCT00939471|Primary|Safety: Device-related Adverse Events During Balloon Dilation Through 12 Months|Number of device-related adverse events from time of procedure through 12 months post-procedure.|12 months|||number of events|||Number
798399|NCT00939484|Secondary|Pharmacokinetic Parameters of Vismodegib, CSF Penetration|The estimated median of cerebrospinal fluid (CSF) drug penetration is reported when expressed as an AUC ratio of CSF vismodegib to that of unbound drug in plasma.|up to 12 month|The calculation of drug penetration is based on patients who had the course 1 plasma and CSF drug concentration data||ratio||Full Range|Median
798400|NCT00939484|Secondary|Duration of Objective Response|The duration of objective response is measured from the initial scan documenting complete or partial response that was subsequently confirmed until the earlier of documented progression or death on study. Duration of objective response is censored at the last tumor assessment date for patients without disease progression who have not died within 30 days of last exposure to study treatment.|From start of treatment up to 2 years|Patients with sustained objective response||months||Full Range|Median
798401|NCT00939484|Secondary|Progression-free Survival|Progression-free survival (PFS) is measured from the date of initial treatment with GDC-0449 until the earliest of progression or death on study. PFS is censored at the last tumor assessment date for patients without disease progression who have not died within 30 days of last exposure to study treatment. Kaplan-Meier method is used to estimate the progression-free survival.|From start of treatment up to 2 years|||months||95% Confidence Interval|Median
798402|NCT00939484|Primary|Objective Response (CR+PR) Sustained for ≥ 8 Weeks|Objective response is either a complete response or a partial response sustained for 8 weeks in a patient. The objective response rate will be reported separately for patients of each stratum. CR is complete disappearance of all enhancing tumor. PR is >= 50% reduction in tumor size.|Up to 12 months|||proportion of participants||95% Confidence Interval|Number
798403|NCT00939510|Primary|RECIST-defined Measurable Disease|Patients who have a response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) by RECIST criteria. To be assigned a status of PR or CR, changes in tumor measurements must be confirmed by repeat assessments that should be performed no less than 4 weeks after the criteria for response are first met. In the case of SD, follow-up measurements must have met the SD criteria at least once after study entry at a minimum interval of 6-8 weeks|every 8 weeks and at end of treatment|12 patients had RECIST-defined measurable disease. One patient came off study early for toxicity and therefore was not evaluable.||participants|||Number
812450|NCT01070784|Primary|ECG Variables - Heart Rate|Change from baseline|Baseline and 52 week after|||beats/minute||Standard Deviation|Mean
798404|NCT00939510|Secondary|Number of Patients With Statistically Significant Change in Immune Response From Baseline to End of Study|The change in mean T cell immunohistochemical markers and dendritic cells over time will be evaluated using analysis of variance methods for repeated measures with additional main factors included in the analysis for subset comparisons. The pattern of immune response will be evaluated based upon overall clinical response using these same techniques.|every 28 days for first 3 cycles, end of study|All patients that received treatment||participants|||Number
798405|NCT00939510|Primary|Number of Patients With a PSA Response|Number of patients with a PSA Response defined as a PSA decline greater or equal to 50% compared with baseline value.|reevaluated for response every eight weeks|All patients that received treatment.||participants|||Number
798406|NCT00939536|Primary|The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞)|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|plasma samples were obtained from blood drawn at 0 (within 60 minutes prior to dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 20 and 24 hours (18 samples) after administration of the dose.|||mcg*hr/mL||Standard Deviation|Mean
798407|NCT00939536|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t)|plasma samples were obtained from blood drawn at 0 (within 60 minutes prior to dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 20 and 24 hours (18 samples) after administration of the dose.|||mcg*hr/mL||Standard Deviation|Mean
798408|NCT00939536|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that the drug reaches in the plasma|plasma samples were obtained from blood drawn at 0 (within 60 minutes prior to dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 20 and 24 hours (18 samples) after administration of the dose.|||ng/ml||Standard Deviation|Mean
798409|NCT00939562|Primary|Area Under Plasma Concentration-Time Profile From Time Zero to Infinity (AUCinf) of Doxycycline|AUCinf = Area under the plasma concentration-time profile from time zero (pre-dose) to infinity.|0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours postdose.|PK||ug*hr/mL||Standard Deviation|Mean
798410|NCT00939562|Primary|Maximum Plasma Concentration (Cmax) of Doxycycline||0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours postdose.|The pharmacokinetic (PK) concentration population was defined as all subjects randomized and treated who had at least 1 concentration in at least 1 treatment period.||ug/mL||Standard Deviation|Mean
798411|NCT00939627|Secondary|Overall Survival Associated With Immunomodulatory Cytokines|Twelve immunomodulatory cytokines were selected based on previous a feasibility study. One cytokines, HGF, was eliminated due to extremely low expression. Three cytokines, TGF-beta 1, IL-8 and VEGF were evaluated for association with survival.|Pre-therapy||||||
798412|NCT00939627|Other Pre-specified|Quality of Life||up to 3 years|The Quality of Life survey instrument was not completed by study participants, thus data is not available for analysis.|||||
798413|NCT00939627|Secondary|Gene Expression Levels|Gene Expression Levels were to be addressed using mostly descriptive statistics.|Pre-therapy and every 21 days for up to 9 weeks||||||
798414|NCT00939627|Secondary|Number of Participants With Each Worst‐Grade Toxicity|Count of patients according to the worst‐grade toxicity experienced by each, where worst‐grade toxicity is per NCI common toxicity criteria: grade 1, mild; grade 2, moderate; grade 3, severe; grade 4, life‐threatening; grade 5, death|On-study date to 30 days following final dose of study drug|Total number of patients reported with any toxicity. Because not all patients experience a toxicity, and some experience more than one; the number of patients analyzed does not coincide with the number of patients on study.||participants|||Number
798415|NCT00939627|Secondary|Overall Survival (OS)|Estimated probable duration of life from on‐study date to date of death from any cause, using the Kaplan‐Meier method with censoring (see analysis population description for additional details)|On-study date to date of death from any cause (assessed up to 3 years)|All patients are included in the analysis on intention-to-treat basis. Analysis is by Kaplan‐Meier method, where death is an event, with censoring for non‐expired patients at greater of off‐study date or last known alive date.||months||95% Confidence Interval|Median
798416|NCT00939627|Secondary|Best Response|"Number of patients in each response category, per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, summarized as follows for target lesion criteria (see RECIST v1.1 for additional details): complete response (CR),disappearance of target lesions; partial response (PR), >=30% decrease in sum of longest diameter of target lesions; progressive disease (PD), >=20% increase in sum of longest diameter (LD) of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or SD.
Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR>PR>SD>PD."|On-treatment date to date of disease progression (assessed up to 3 years)|All patients with best overall response data. Patients are excluded if best overall response data is missing or if the patient is not evaluable for best overall response.||participants|||Number
798417|NCT00939627|Primary|Progression Free Survival (PFS)|Estimated probable duration of life without disease progression, from on‐study date to earlier of progression date or date of death from any cause, using the Kaplan‐Meier method with censoring (see analysis population description for additional details). Disease progression is defined under Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as >=20% increase in sum of longest diameters of target lesions, unequivocal progression of non‐target lesions, or appearance of new lesions.|On‐study date to lesser of date of progression or date of death from any cause (assessed up to 3 years)|All patients are included in the analysis on intention-to-treat basis. Analysis is by Kaplan‐Meier method, where either death or progression is an event, with censoring for non‐progressed, non‐expired patients at greater of off-study date or last known alive date.||months||95% Confidence Interval|Median
798418|NCT00939692|Primary|The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞)|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.|||ng·h/mL||Standard Deviation|Mean
798419|NCT00939692|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t)|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.|||mcg*hr/mL||Standard Deviation|Mean
798420|NCT00939692|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that the drug reaches in the plasma|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.|||ng/ml||Standard Deviation|Mean
798421|NCT00939705|Primary|The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞)|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.|Pharmacokinetic analyses are based on 18 out of 18 enrolled subjects who completed this study.||ng h / ml|Participants|Standard Deviation|Mean
798422|NCT00939705|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t)|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.|Pharmacokinetic analyses are based on 18 out of 18 enrolled subjects who completed this study.||ng h / ml|Participants|Standard Deviation|Mean
798423|NCT00939705|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that the drug reaches in the plasma.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.|Pharmacokinetic analyses are based on 18 out of 18 enrolled subjects who completed this study.||ng / ml|Participants|Standard Deviation|Mean
798424|NCT00939731|Secondary|Apparent Volume of Distribution (Vz/F)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, 84 and 96 hrs post PF-02341066 dose in period 1 and additional 168 hrs post PF-02341066 dose in period 2|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||L||Standard Deviation|Geometric Mean
798425|NCT00939731|Secondary|Apparent Oral Clearance (CL/F)|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.|0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, 84 and 96 hrs post PF-02341066 dose in period 1 and additional 168 hrs post PF-02341066 dose in period 2|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||L/hr||Standard Deviation|Geometric Mean
798426|NCT00939731|Primary|Maximum Observed Plasma Concentration (Cmax)||0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, 84 and 96 hrs post PF-02341066 dose in period 1 and additional 168 hrs post PF-02341066 dose in period 2|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng/mL||Standard Deviation|Geometric Mean
798427|NCT00939731|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞])|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, 84 and 96 hrs post PF-02341066 dose in period 1 and additional 168 hrs post PF-02341066 dose in period 2|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng*hr/mL||Standard Deviation|Geometric Mean
798428|NCT00939731|Secondary|Plasma Decay Half Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, 84 and 96 hrs post PF-02341066 dose in period 1 and additional 168 hrs post PF-02341066 dose in period 2|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||hr||Standard Deviation|Mean
798429|NCT00939731|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, 84 and 96 hrs post PF-02341066 dose in period 1 and additional 168 hrs post PF-02341066 dose in period 2|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||hr||Full Range|Median
798430|NCT00939731|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast).|0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, 84 and 96 hours (hrs) post PF-02341066 dose in period 1 and additional 168 hrs post PF-02341066 dose in period 2|Pharmacokinetic (PK) parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng*hr/mL||Standard Deviation|Geometric Mean
798464|NCT00940017|Primary|Concentration Ratio in ELF to Plasma|Concentration ratio in ELF to plasma determined by a point estimate within each subject at the time-point where ELF data was available.|4, 8, 12, 24 hours after start of infusion|PK parameter analysis population; summary parameters derived using average data for all subjects. Subjects randomized to a single BAL procedure timepoint; bronchoscopy and BAL done for 5 different subjects at each timepoint.||ratio||Standard Deviation|Mean
799136|NCT00952211|Secondary|Hospital Anxiety and Depression (HADS) Scale -Depression Subscale|HADS depression subscale: 7 items, range 0-21. Higher score indicates worse symptoms|10 days after beginning CPAP treatment|||units on a scale||Standard Deviation|Mean
798431|NCT00939783|Secondary|Percentage of Participants With Clinically Significant Electrocardiogram (ECG) Findings|Abnormal ECG findings included maximum value of >=300 millisecond (msec), maximum increase of >=25% for baseline value of >200 msec and maximum increase of >=50% for baseline value of <=200 msec for PR interval (int); maximum increase of >=25% for baseline value of >100 msec and maximum increase of >=50% for baseline value of <=100 msec for QRS interval; maximum value of >450 to <=480, >480 to <=500 and >500 msec, increase of >30 to <=60 and >60 msec for QT interval corrected using Fridericia's formula (QTcF).|Baseline up to Week 65 (end of treatment)|Safety analysis set included all the participants who received at least one dose of study medication, including partial doses. Here 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure and 'n' is signifying those participants who were evaluable for a particular category.||Percentage of participants|||Number
798432|NCT00939783|Secondary|Percentage of Participants With Abnormal Clinically Significant Laboratory Values|For hematology, liver function, renal function, electrolytes, clinical chemistry, abnormality was reported if observed value was more than or less than X times upper limit of normal (ULN) or lower limit of normal (LLN); X=specified in categories of each parameter in measured values section. For urinalysis abnormality was reported if result was >=1 in qualitative test of all parameters except red and white blood cells which were reported if result was >=6, indicating levels in urine were abnormal. Urine pH abnormality reported if >8 and urine specific gravity abnormality if <1.003 or >1.030.|Baseline up to Week 65 (end of treatment)|Safety analysis set included all the participants who received at least one dose of study medication, including partial doses. Here 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure and 'n' is signifying those participants who were evaluable for a particular laboratory parameter.||Percentage of participants|||Number
798433|NCT00939783|Secondary|Percentage of Participants With Abnormal Clinically Significant Vital Signs|Abnormal clinically significant vital signs included absolute systolic blood pressure (BP) values less than (<) 90 millimeter of mercury (mmHg), maximum increase or decrease of greater than or equal to (>=) 30 mmHg from baseline for systolic BP; absolute diastolic BP <50 mmHg with maximum increase or decrease of >=20 mmHg from baseline and absolute heart rate values <40 beats per minute (bpm), >120 bpm for supine or sitting measurement, >140 bpm for standing measurement.|Baseline up to Week 65 (end of treatment)|Safety analysis set included all the participants who received at least one dose of study medication, including partial doses. Here 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure and 'n' is signifying those participants who were evaluable for a particular category.||Percentage of participants|||Number
798434|NCT00939783|Primary|Percentage of Participants With Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|Baseline up to Week 65 (end of treatment)|Safety analysis set included all the participants who received at least one dose of study medication, including partial doses.||Percentage of participants|||Number
798435|NCT00939796|Secondary|Tube Retention|Presence of the Tympanostomy Tube across the tympanic membrane at two weeks post-procedure. Evaluated for test cohort subjects only (not lead-in subjects).|two weeks post-procedure|||retained tubes|Participants||Number
798436|NCT00939796|Secondary|Cross-Over to Manual Myringotomy and Tube Placement|Conversion of the procedure from Tympanostomy Tube Delivery System to manual myringotomy and tube placement. Evaluated for test cohort subjects only (not lead-in subjects). Decision to convert to a manual myringotomy and tube placement procedure occurs at the conclusion of the Tube Delivery System procedure.|at procedure visit|||number of ears|Participants||Number
798437|NCT00939796|Primary|Device Success|Successful deployment of the tube in each indicated ear using the TTDS. Evaluated for test cohort subjects only (not lead-in subjects).|At procedure visit|All TTDS devices attempted||devices|Participants||Number
798438|NCT00939809|Secondary|Biomarkers of Drug Effect on Peripheral Blood Mononuclear Cells (PBMCs)|Note: due to the limited activity of this agent, it was decided not to expend resources assaying the PBMCs.|Day 1 prior to dosing; Day 2 prior to dosing and 4-hour post dosing; Day 8 prior to dosing.||||||
798439|NCT00939809|Secondary|Overall Survival||Every other cycle, up to 5 years|Eligible and treated participants||months||95% Confidence Interval|Median
798440|NCT00939809|Secondary|Progression-free Survival|"Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions.
CT scan or MRI is used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response."|scans to assess response were done every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels.|Eligible and treated participants||months||95% Confidence Interval|Median
798441|NCT00939809|Primary|Frequency and Severity of Adverse Events as Assessed by CTCAE v3.0||Every cycle during treatment||||||
798442|NCT00939809|Primary|Tumor Response|"Complete and Partial Tumor Response by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Per RECIST v1.0 for target lesions and assessed by MRI or CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD.
CT scan or MRI is used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response."|Scans to assess response were done every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels.|Eligible and treated participants||percentage of participants||90% Confidence Interval|Number
799409|NCT00947349|Secondary|Cavg for BI 201335 ZW|average plasma concentration (Cavg) of BI 201335 ZW|10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose|PKS||ng/mL||Geometric Coefficient of Variation|Geometric Mean
798443|NCT00939809|Primary|Progression-free Survival at 6 Months|"Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions.
CT scan or MRI is used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response."|Scans to assess progression were done every other cycle for the first 6 months.|Eligible and treated participants||percentage of participants||90% Confidence Interval|Number
798444|NCT00939874|Secondary|Percentage of Participants With HIV Viral Load <50 Copies/mL|Plasma HIV viral load remained <50 copies/mL|from Baseline to Week 96|Week 96 data were available for 32 completed participants||percentage of participants|||Number
798445|NCT00939874|Primary|Percent Change in Bone Mineral Density (BMD) of Lumbar Spine and Hips|Percent Change in Bone Mineral Density of Lumbar Spine and Hips from Baseline to Weeks 48 and 96|from Baseline to Weeks 48 and 96|Week 48 data were available for 37 completed participants and Week 96 data were available for 32 completed participants. Fifteen of the enrolled 52 participants were screen failures.||percent change||95% Confidence Interval|Mean
798446|NCT00939900|Secondary|Time to Total Arthroplasty or Joint Preserving Surgery||Measurement will be done at 0m, 3m, 6m, 9m, 12m, 18m, 24m)||||||
798447|NCT00939900|Secondary|Time to Collapse of Femoral Head||Measurement will be done at 0m, 3m, 6m, 9m, 12m, 18m, 24m)||||||
798448|NCT00939900|Secondary|Change of HHS (Harris Hip Scores), WOMAC Score, SF-36||Measurement will be done at 0m, 3m, 6m, 9m, 12m, 18m, 24m)||||||
798449|NCT00939900|Secondary|Collpase Rate of Femoral Head||Measurement will be done at 0m, 3m, 6m, 9m, 12m, 18m, 24m)||||||
798450|NCT00939900|Primary|Number of Participants With Femoral Head Collapse Within 24 Months||Measurements were done at 6, 12, 24 months|||participants|||Number
798451|NCT00939952|Primary|Residual Drug in Peritoneal Cavity After 1st Exchange||6h|||mg||Standard Deviation|Mean
798452|NCT00939952|Primary|k31|1st order intercompartmental rate constant peritoneal cavity to central|12h|||h^(-1)||Standard Deviation|Mean
798453|NCT00939952|Primary|k13|1st order intercompartmental rate constant from central to peritoneal cavity|12h|||h^(-1)||Standard Deviation|Mean
798454|NCT00939952|Primary|k21|1st order intercompartmental rate constant from peripheral to central compartment|12h|||h^(-1)||Standard Deviation|Mean
798455|NCT00939952|Primary|k12|1st order intercompartmental rate constant between central and peripheral compartments|12h|||h^(-1)||Standard Deviation|Mean
798456|NCT00939952|Primary|Clearance (CL)|population PK clearance|12h|||Liters/hour (L/h)||Standard Deviation|Mean
798457|NCT00939952|Primary|Volume of Distribution, Central Compartment (Vc)|Population PK|12h|||Liters (L)||Standard Deviation|Mean
798458|NCT00939991|Secondary|Phase II: Number of Patients With Grade 2 or Greater, Treatment-related Toxicities|Phase II: Number of patients with grade 2 or greater, treatment-related toxicities based on Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|3 years|||participants|||Number
798459|NCT00939991|Secondary|Phase II: Median Overall Survival (OS)|Phase II: Time in months from the start of study treatment to date of death due to any cause. Patients alive as of the last follow-up had OS censored at the last follow-up date. Median OS was estimated using a Kaplan-Meier curve.|3 years|||months||95% Confidence Interval|Median
798460|NCT00939991|Secondary|Phase II: Median Progression-free Survival (PFS)|Phase II: Time in months from the start of study treatment to the date of first progression according to RANO criteria, or to death due to any cause. Per RANO, progression is a ≥ 25% increase in the sum of the products of perpendicular diameters of enhancing lesions, any new lesion or clinical deterioration. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve.|3 years|||months||95% Confidence Interval|Median
798461|NCT00939991|Secondary|Phase II: Radiographic Response.|The percentage of participants with a complete or partial response as determined by modified Response Assessment in Neuro-Oncology (RANO) criteria. A confirmation of response was not required. Complete Response (CR) was defined as complete disappearance on MR/CT of all enhancing tumor and mass effect, off all corticosteroids (or receiving only adrenal replacement doses) and accompanied by a stable or improving neurologic examination. Partial Response (PR) was defined as greater than or equal to 50% reduction in tumor size on MR/CT by bi-dimensional measurement, on a stable or decreasing dose of corticosteroids and accompanied by a stable or improving neurologic examination. Tumor assessments were done at baseline, the end of the first cycle (4 weeks), then the end of every second cycle (every 8 weeks) thereafter.|3 years|||percentage of participants||95% Confidence Interval|Number
798462|NCT00939991|Primary|Phase II: 6-month Progression-free Survival (PFS)|Phase II: Percentage of participants surviving six months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to RANO criteria, or to death due to any cause. Per RANO, progression is a ≥ 25% increase in the sum of the products of perpendicular diameters of enhancing lesions, any new lesion or clinical deterioration.|6 months|||percentage of participants||95% Confidence Interval|Number
798463|NCT00939991|Primary|Phase I: Determination of the Maximum Tolerated Dose (MTD)|The MTD is based upon dose-limiting toxicities (DLTs) experienced during Cycle 1 of treatment. The MTD is the dose level at which 0/6 or 1/6 patients experience DLT with at least two patients experiencing DLT at the next higher dose level. Using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, DLTs are defined as: Grade 4 neutropenia lasting greater than 5 days; Grade 3 thrombocytopenia; the occurrence of non-hematologic Grade 3 or greater drug-related adverse events excluding Grade ≥ 3 elevation in alkaline phosphatase, Grade ≥ 3 nausea or vomiting unless occurring despite the use of standard anti-emetics or Grade 3 diarrhea unless occurring despite standard anti-diarrheal therapy; > 14 day delay to re-treat due to failure to resolve drug-related toxicity to re-treatment criteria or pre-treatment baseline.|Cycle 1 (28 days)|||mg|||Number
798995|NCT00950963|Other Pre-specified|Number of Total Emergency Department (ED) Visits and Hospital Admissions During the Follow up Period.|Evaluate the effect of the intervention on healthcare utilization as defined by ED visits and hospitalizations|18 months|Analysis per intention to treat||Number of ED visits and hospitalizations|||Number
798465|NCT00940017|Primary|Overall Drug Penetration Ratio in ELF|ELF collected by bronchoscopy and BAL on Day 3. ELF to plasma penetration ratio calculated by dividing area under the plasma concentration-time profile (AUC) in ELF by AUC in plasma from 20 subjects where t is 24 hours for anidulafungin and 12 hours for voriconazole. Summary parameters were derived using average data for all subjects and associated to a single subject for reporting purposes (mean with standard deviation was not calculated).|4, 8, 12, 24 hours after start of infusion|PK parameter analysis population; summary parameters derived using average data for all subjects.||average ELF to plasma ratio|||Number
798466|NCT00940017|Primary|AM: t1/2|t1/2 = terminal elimination half-life in hours; Loge(2)Kel, where Kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. AM collected by bronchoscopy and BAL on Day 3.|4, 8, 12, 24 hours after start of infusion|PK parameter analysis population; summary parameters derived using average data for all subjects. Data in AM did not allow calculation of t1/2; not analyzed.||hours|||Number
798467|NCT00940017|Primary|AM: AUCtau|AUCtau = area under the plasma concentration-time profile from time zero (0) to time = t (AUCt), the dosing interval, where t is 24 hours for anidulafungin and 12 hours for voriconazole. AM collected by bronchoscopy and BAL on Day 3. Summary parameters were derived using average data for all subjects and associated to a single subject for reporting purposes (mean with standard deviation was not calculated).|4, 8, 12, 24 hours after start of infusion|PK parameter analysis population; summary parameters derived using average data for all subjects.||average concentration (ug*hr/mL)|||Number
798468|NCT00940017|Primary|AM: Tmax|Tmax = time (hours) to maximum plasma concentration (Cmax). Observed directly from data as time of first occurrence. AM collected by bronchoscopy and BAL on Day 3.|4, 8, 12, 24 hours after start of infusion|PK parameter analysis population; summary parameters derived using average data for all subjects.||hours|||Number
798469|NCT00940017|Primary|Alveolar Macrophages (AM): Cmax|Cmax = maximum observed plasma concentration; observed directly from the data. AM collected by bronchoscopy and BAL on Day 3. Summary parameters were derived using average data for all subjects and associated to a single subject for reporting purposes (mean with standard deviation was not calculated).|4, 8, 12, 24 hours after start of infusion|PK parameter analysis population; summary parameters derived using average data for all subjects.||average concentration (ug/mL)|||Number
798470|NCT00940017|Primary|ELF PK: t1/2|t1/2 = terminal elimination half-life in hours; Loge(2)/Kel, where Kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. ELF collected by bronchoscopy and BAL on Day 3.|4, 8, 12, 24 hours after start of infusion|PK parameter analysis population; summary parameters derived using average data for all subjects. Data in ELF did not allow calculation of t1/2; not analyzed.||hours|||Number
798471|NCT00940017|Primary|ELF PK: AUCtau|AUCtau = area under the plasma concentration-time profile from time zero (0) to time = t (AUCt), the dosing interval, where t is 24 hours for anidulafungin and 12 hours for voriconazole. ELF collected by bronchoscopy and BAL on Day 3. Summary parameters were derived using average data for all subjects and associated to a single subject for reporting purposes (mean with standard deviation was not calculated).|4, 8, 12, 24 hours after start of infusion|PK parameter analysis population; summary parameters derived using average data for all subjects.||average concentration (ug*hr/mL)|||Number
798472|NCT00940017|Primary|ELF PK: Tmax|Tmax = time (hours) to maximum plasma concentration (Cmax). Observed directly from data as time of first occurrence. ELF collected by bronchoscopy and BAL on Day 3.|4, 8, 12, 24 hours after start of infusion|PK parameter analysis population; summary parameters derived using average data for all subjects.||hours|||Number
798473|NCT00940017|Primary|Epithelial Lining Fluid (ELF) PK: Cmax|Cmax=maximum observed plasma concentration. ELF collected by bronchoscopy and bronchoalveolar lavage (BAL) Day 3; determined from BAL sample using urea dilution method: [Drug ELF]=[Drug BAL] multiplied by [Urea SERUM] divided by [Urea BAL]. Drug ELF=anidulafungin or voriconazole (drug) concentration in ELF corrected for dilution; Drug BAL=assayed drug concentration in BAL; Urea SERUM and Urea BAL simultaneously collected. Summary parameters derived using average data for all subjects; associated to a single subject for reporting purposes (mean with standard deviation not calculated).|4, 8, 12, 24 hours after start of infusion|PK parameter analysis population; summary parameters derived using average data for all subjects.||average concentration (ug/mL)|||Number
798474|NCT00940017|Primary|Plasma PK: Volume of Distribution at Steady-state (Vss)|Vss = volume of distribution at steady-state; measured as liters (L). Calculated as (CL multiplied by mean residence time extrapolated to infinity [MRTinf]). MRTinf = [(AUMCt plus t (AUCinf minus AUCt)) divided by AUCt] minus (infusion time divided by 2); AUMCt = area under the first moment curve from time zero to time t; AUCinf = area under the plasma concentration-time curve extrapolated to infinity.|100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion|PK parameter analysis population; (n) = number of subjects contributing to the mean.||L||Standard Deviation|Mean
798475|NCT00940017|Primary|Plasma PK: Total Clearance (CL Total)|CL total = total clearance calculated as dose divided by AUCt; measured as milliliters per minute (mL/min). Collected on Day 3.|100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion|PK parameter analysis population||mL/min||Standard Deviation|Mean
798476|NCT00940017|Primary|Plasma PK: Plasma Elimination Half-life (t1/2)|t1/2 = terminal elimination half-life in hours; Loge(2)/Kel, where Kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Collected on Day 3.|100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion|PK parameter analysis population; (n) = number of subjects contributing to the mean||hours||Standard Deviation|Mean
798477|NCT00940017|Primary|Plasma PK: Area Under the Curve From Time Zero to Time = Tau (AUCtau)|AUCtau = area under the plasma concentration-time profile from time zero (0) to time = t (AUCt), the dosing interval, where t is 24 hours for anidulafungin and 12 hours for voriconazole; measured as micrograms times hours per milliliter (ug*hr/mL). Collected on Day 3.|100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion|PK parameter analysis population defined as all subjects randomized and treated who had at least 1 of the PK parameters of primary interest.||ug*hr/mL||Standard Deviation|Mean
798478|NCT00940017|Primary|Plasma PK: Time to Reach Maximum Plasma Concentration (Tmax)|Tmax = time (hours) to maximum plasma concentration (Cmax). Observed directly from data as time of first occurrence. Collected on Day 3.|100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion|PK parameter analysis population||hours||Full Range|Median
812451|NCT01070784|Primary|Vital Signs- Pulse Rate|Change from baseline|Baseline and 52 week after|||beats/minute||Standard Deviation|Mean
798479|NCT00940017|Primary|Plasma Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax)|Cmax = maximum observed plasma concentration; measured in micrograms per milliliter (ug/mL). Observed directly from the data. Collected on Day 3.|100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion|PK parameter analysis population||ug/mL||Standard Deviation|Mean
798480|NCT00940108|Secondary|Frequency and Intensity of Unsolicited Adverse Events After the First or Second Vaccination|Unsolicited AEs included AEs other than those specifically sought for. Grade 1 unsolicited AE definition: Easily tolerated and did not interfere with normal daily activities. Grade 2 unsolicited AE definition: Some interference with normal daily activities. Grade 3 unsolicited AE definition: Prevented normal daily activities.|During the 21 days after each vaccination; up to 180 days after the last vaccination for SAEs, AESIs, and NOCIs|The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.||percentage of participants|||Number
798481|NCT00940108|Secondary|Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs)|An AESI was defined as an AE for which the association with seasonal influenza vaccine was unclear. A NOCI was defined as the diagnosis of a new medical condition that was chronic in nature, including those potentially controllable by medication (eg, diabetes, asthma).|Up to 180 days after the last vaccination|The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.||percentage of participants|||Number
798482|NCT00940108|Secondary|Duration of Solicited AEs After the Second Vaccination|Solicited AEs included AEs that were specifically sought for.|During the 7 days after the second vaccination and up to Day 20 after the second vaccination if AE was ongoing at Day 7.|The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.||days||Standard Deviation|Mean
798483|NCT00940108|Secondary|Duration of Solicited AEs After the First Vaccination|Solicited AEs included AEs that were specifically sought for.|During the 7 days after the first vaccination and up to Day 20 after the first vaccination if AE is ongoing at Day 7.|The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.||days||Standard Deviation|Mean
798484|NCT00940108|Secondary|Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination|Solicited AEs included AEs that were specifically sought for. Grade 3 solicited AE definitions: Cried when limb was moved/spontaneously painful (Cohort A) or prevented normal daily activities (Cohort B) for injection site pain; Size > 100 mm for injection site redness and induration/swelling; Temperature > 103.1°F (39.5°C) for fevers; Prevented normal daily activities or required medical intervention for all other systemic AEs.|During the 7 days after each vaccination|The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.||percentage of participants|||Number
798485|NCT00940108|Primary|Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More After the Second Vaccination||21 days after the second vaccination|The Evaluable Population (for the second vaccination) comprised all randomised participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).||percentage of participants||95% Confidence Interval|Number
798486|NCT00940108|Primary|Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More After the First Vaccination||21 days after the first vaccination|The Evaluable Population (for the first vaccination) comprised all randomised participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).||percentage of participants||95% Confidence Interval|Number
798487|NCT00940108|Primary|GMFI in the HI Antibody Titre After the Second Vaccination|GMFI in HI antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre.|Before and 21 days after the second vaccination|The Evaluable Population (for the second vaccination) comprised all randomised participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).||geometric mean fold increase||95% Confidence Interval|Geometric Mean
798488|NCT00940108|Primary|Geometric Mean Fold Increase (GMFI) in the HI Antibody Titre After the First Vaccination|GMFI in HI antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre.|Before and 21 days after the first vaccination|The Evaluable Population (for the first vaccination) comprised all randomised participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).||geometric mean fold increase||95% Confidence Interval|Geometric Mean
798489|NCT00940108|Primary|HI Antibody Titre Seroconversion Rate After the Second Vaccination|HI antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination HI antibody titre of 1:40 or more; or participants with a pre-vaccination HI titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre.|Before and 21 days after the second vaccination|The Evaluable Population (for the second vaccination) comprised all randomised participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).||percentage of participants||95% Confidence Interval|Number
798490|NCT00940108|Primary|Haemagglutination Inhibition (HI) Antibody Titre Seroconversion Rate After the First Vaccination|HI antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination HI antibody titre of 1:40 or more; or participants with a pre-vaccination HI titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre.|Before and 21 days after the first vaccination|The Evaluable Population (for the first vaccination) comprised all randomised participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).||percentage of participants||95% Confidence Interval|Number
798491|NCT00940290|Primary|Change in Behavior in Physicians Attitude Towards a Decision to Give a Medication|"A fictitious clinical case of a child with acute diarrhea was presented. The physician read the case and then answered the question would you recommend racecadotril to this patient? A zero to 10 visual-analog scale and a Likert scale were used to measure the decision of the physician related to the clinical case presented (from zero=definitely no to 10=definitely yes). Mean differences before-after and among groups were measured on the 10 centimeters scale."|One day|||Mean change in centimeters||95% Confidence Interval|Mean
798492|NCT00940485|Secondary|Number of Participants With Laboratory Abnormalities Which Were Captured as an Adverse Event|Participants with clinically significant laboratory abnormalities which were captured as an AE (at the >=5% threshold) were presented.|Up to Week 48|Safety set (SS) included all the participants who received at least 1 dose of study drug and who had at least undergone safety assessment once, regardless of whether the patients withdrew from the study or not.||Participants|||Number
798493|NCT00940485|Secondary|Number of Participants With Incidence of Adverse Events and Serious Adverse Events|An adverse event (AE) was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A Serious Adverse Events (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.|Up to Week 48|Safety set (SS) included all the participants who received at least 1 dose of study drug and who had at least undergone safety assessment once, regardless of whether the patients withdrew from the study or not.||Participants|||Number
798494|NCT00940485|Secondary|Quantitative Change in Mean Hepatitis B Surface Antigen Change Over Time|Quantitative Hepatitis B Surface Antigen (HBsAg) results were analyzed in central lab. Values that were less than LLOQ had been replaced by LLOQ when analyzed, e.g. <1000 was replaced by 1000 and <0.2 was replaced by 0.2. Quantitative HBsAg calculated using ‘International Units Per Millilitre’ (IU/mL). Change in HBsAg was analysed at Weeks 0, 8, 12, 24, 36, and 48.|Up to Week 48|Full analysis set included all patients who were randomized and received at least one dose of the study drug. Maximum participants available at particular time point were analysed.||IU/ml||Standard Deviation|Mean
798495|NCT00940485|Secondary|Quantitative Change in Mean Hepatitis B Envelope Antigen Over Time|Quantitative hepatitis B envelope antigen (HBeAg) results were analyzed in central lab. Values that were less than lower limit of quantification (LLOQ) had been replaced by LLOQ when analyzed, e.g. <1000 was replaced by 1000 and <0.2 was replaced by 0.2. Quantitative HBeAg value unit was calculated using ‘Paul Ehrlich Institute units per millilitre’ (PEIU/ml). Change in HBeAg was analysed at Weeks 0, 8, 12, 24, 36, and 48.|Up to Week 48|Full analysis set included all patients who were randomized and received at least one dose of the study drug. Maximum participants available at particular time point were analysed.||PEIU/ml)||Standard Deviation|Mean
798496|NCT00940485|Secondary|Percentage of Participants With Normalized Alanine Aminotransferase at Week 48|Normalized Alanine Aminotransferase (ALT) is defined as having a baseline ALT value > upper limit of normal (ULN), and a decrease in ALT value to ≤ ULN at the given time point.|At Week 48|Full analysis set included all patients who were randomized and received at least one dose of the study drug.||Percentage of participants||95% Confidence Interval|Number
798497|NCT00940485|Secondary|Percentage of Participants With Hepatitis B Surface Antigen Seroconversion at Week 48|Hepatitis B Surface Antigen (HBsAg) seroconversion was defined as loss of HBsAg and presence of anti-HBs .(antibody to Hepatitis B surface antigen)|At Week 48|Full analysis set included all patients who were randomized and received at least one dose of the study drug.||Percentage of participants||95% Confidence Interval|Number
798498|NCT00940485|Secondary|Percentage of Participants With Hepatitis B Surface Antigen Loss at Week 48|Loss of Hepatitis B Surface Antigen (HBsAg) was defined as change of detectable HBsAg from positive to negative.|At Week 48|Full analysis set included all patients who were randomized and received at least one dose of the study drug.||Percentage of participants||95% Confidence Interval|Number
798499|NCT00940485|Secondary|Percentage of Participants With Hepatitis B Virus - Deoxyribonucleic Acid <1000 Copies/ Millilitre at Week 48|Blood was collected for Hepatitis B Virus - Deoxyribonucleic Acid (HBV -DNA) and was analysed at the central laboratories using the Roche approved polymerase chain reaction (PCR) methodology at Week 48. Percentage of participants with HBV-DNA < 1000 copies/mL was reported.|At Week 48|Full analysis set included all patients who were randomized and received at least one dose of the study drug.||Percentage of participants||95% Confidence Interval|Number
798500|NCT00940485|Secondary|Percentage of Participants With Loss of Hepatitis B Envelope Antigen at Week 48|Loss of Hepatitis B Envelope Antigen (HBeAg) is defined as the absence of HBeAg.|At Week 48|Full analysis set included all patients who were randomized and received at least one dose of the study drug.||Percentage of participants||95% Confidence Interval|Number
798501|NCT00940485|Primary|Percentage of Participants With Hepatitis B Envelope Antigen Seroconversion at Week 48|Hepatitis B envelope Antigen (HBeAg) seroconversion was defined as the absence of HBeAg and the presence of antibody to Hepatitis B envelope antigen (anti-HBe).|At Week 48|Full analysis set included all patients who were randomized and received at least one dose of the study drug.||Percentage of participants||95% Confidence Interval|Number
798502|NCT00940537|Secondary|T2 (Spin-spin Relaxation Time) Ratios of Triglyceride/Water|T2 (spin-spin relaxation time) ratios of triglyceride/water using optimized PRESS sequences|baseline cross-sectional measurements|This analysis was per protocol.||ratio||Standard Deviation|Mean
798503|NCT00940537|Secondary|The Hepatic Triglyceride Content Pre- and Post-prandial.|We compared the intrahepatic triglyceride content in subjects after a 12 hour fast and 2 hours after eating a high fat, high carbohydrate meal. The measure reported here is for the pre and post prandial results given as the ratio of triglyceride signal to water signal. After showing its reliability, we chose to use the results from the optimized breath-hold sequence.|after a 12 hour fast and 2 hours post-prandial|||ratio||Standard Error|Mean
798504|NCT00940537|Primary|The Reproducibility of the Hepatic Triglyceride Content Measurement by MRS.|We compared three 1H-Magnetic Resonance Spectroscopy sequences: A Standard Siemens sequence, and an optimized sequence with either breath-holds or free-breathing. Repeat scans were done with the subject briefly removed from and returned to the scanner between scans. The results given are coefficients of variation of the triglyceride signal divided by the water signal.|6 months|||coefficient of variation||Standard Error|Mean
798505|NCT00940576|Primary|Score of Crohn´s Disease and/or Ulcerative Colitis|score for Crohn´s disease: Crohn´s Disease Activity Index (CDAI), < 150 = remission, 151-220 = moderate activity, 221-450 = severe activity; score for ulcerative colitis: Colitis Activity Index (CAI), 0-4 = remission, 5-9 = low activity, 10-16 = moderate activity, 17-23 = high activity.|8 weeks|||units on a scale||Standard Deviation|Mean
798506|NCT00940576|Secondary|Extra-intestinal Pain|The patients recorded daily their extraintestinal disorders (fever, anal fissures, stomatitis, arthralgia, skin irritation) using a treatment improvement protocol (TIP).|8 weeks|||Percentage of days with pain||Standard Deviation|Mean
798507|NCT00946296|Primary|Blood Loss During Surgery|Blood loss in milliliters during surgery.|up to 162 minutes|||mL||Standard Deviation|Mean
798508|NCT00946309|Primary|3-alpha-diol Gluconate Levels|Change in serum 3-alpha-diol gluconate(3α-DG) levels|Baseline and 5 weeks|Due to budget restrictions, outcome data from only collected from the first 25 participants||ng/mL||Standard Deviation|Mean
798509|NCT00946309|Primary|Testosterone Levels|Change in testosterone (T) levels|Baseline and 5 weeks|Due to budget restrictions, outcome data from only collected from the first 25 participants||ng/dL||Standard Deviation|Mean
798510|NCT00946309|Primary|DHT Levels|Change in serum dihydrotestosterone (DHT) levels|Baseline and 5 weeks|Due to budget restrictions, outcome data from only collected from the first 25 participants||pg/mL||Standard Deviation|Mean
798511|NCT00946309|Primary|DNA Oxidation|Prostate tissue 8-hydroxy-2’-deoxyguanosine (8OHdG) levels|Five weeks|Outcome data were not collected due to budget restrictions|||||
798512|NCT00946309|Primary|Lipid Oxidation|Blood F2 Isoprostane levels|Baseline and 5 weeks|Outcome data were not collected due to budget restrictions|||||
798513|NCT00946309|Primary|Gene Expression of Phase II Enzymes|Change in Phase II enzyme expression|Baseline and 5 weeks|Due to budget restrictions, outcome data from only collected from the first 20 participants||-fold change in expression||Standard Deviation|Mean
798514|NCT00946322|Secondary|Partner-reported Dyadic Adjustment Scale|Partner-reported total score on the Dyadic Adjustment Scale, which is a measure of couple relationship satisfaction. Possible range 0-151. Higher = worse.|Pre- to post-treatment (~20 weeks)|Participants completing pre- and post-treatment assessment were analyzed.||units on a scale||Standard Deviation|Mean
798515|NCT00946322|Secondary|Partner-reported Beck Depression Inventory - II|Partner-reported Beck Depression Inventory - II (BDI-II) total severity score. Possible range 0-63. Higher = worse.|Pre- to post-treatment (~20 weeks)|Participants completing the pre- and post-treatment assessment were included||units on a scale||Standard Deviation|Mean
798516|NCT00946322|Primary|Partner-reported PTSD Checklist|Partner-reported total severity score for patient's PTSD symptoms on the PTSD Checklist - Specific (PCL-S) version. Possible range 17-85. Higher = worse.|Pre- to post-treatment (~20 weeks)|Participants completing pre- and post-treatment assessment||units on a scale||Standard Deviation|Mean
798517|NCT00946322|Primary|Patient-reported PTSD Checklist|Patient self-reported total severity score on the PTSD Checklist - Specific (PCL-S) version. Possible range of scores 17-85. Higher = worse.|Pre- to post-treatment (~20 weeks)|Participants completing pre- and post-treatment assessments were included.||units on a scale||Standard Deviation|Mean
798518|NCT00946322|Secondary|Patient-reported Dyadic Adjustment Scale|Patient-reported total score on the Dyadic Adjustment Scale (DAS), which is a measure of couple relationship satisfaction. Possible range = 0 - 151. Higher = worse.|Pre- to post-treatment (~20 weeks)|Participants completing pre- and post-treatment assessment were analyzed||units on a scale||Standard Deviation|Mean
798519|NCT00946322|Secondary|Patient-reported Beck Depression Inventory - II (BDI-II)|Patient-reported total severity score on Beck Depression Inventory - II (BDI-II). Possible range 0-63. Higher = worse.|Pre- to post-treatment|Participants completing the BDI-II at pre- and post-treatment were analyzed||units on a scale||Standard Deviation|Mean
798520|NCT00946322|Primary|Percentage Days of Heavy Drinking|Percentage days of heavy drinking (PDHD) was calculated by dividing the number of days in which the Veteran consumed more than six standard drinks by the total days in the period. Both partners reported upon the Veterans’ drinking behaviors. Following common practice in AUD research (e.g., McCrady, Epstein, Cook, Jensen, & Hildebrandt, 2011), we used the highest report of the two regarding PDHD to reduce possible underreporting. Possible range of scores 0-100%. Higher = worse.|Pre- to post-treatment (~20 weeks)|Participants completing pre- and post-treatment assessments were analyzed||percentage of days of heavy drinking||Standard Deviation|Mean
798521|NCT00946322|Primary|Clinician-administered PTSD Scale (CAPS)|Total severity score on the CAPS was used. Higher = worse outcome. Possible range of scores 0-135.|Pre- to post-treatment (~20 weeks)|Participants completing both pre- and post-treatment assessments were analyzed.||units on a scale||Standard Deviation|Mean
798522|NCT00946348|Secondary|To Assess the Effects of Dronabinol in This Population to Determine Whether Measures of Craving, Mood and Negative Symptoms Will Improve Using the PANSS; and to Determine Whether Measures of Psychotic Symptoms and Cognitive Deficits Will Increase.||Over 8 hours||||||
798523|NCT00946348|Primary|fMRI Connectivity of Regions of Interest (ROI) Within the Brain Reward Circuitry (BRC).|Average Z scores for the region-of-interest functional connectivity at the second scan (when subjects received either a cannabis cigarette or 15mg of dronabinol) between the bilateral nucleus accumbens (NAc) and ventral anterior cingulate cortex (vACC) for patients with schizophrenia and co-occurring cannabis use disorder.|Measures were acquired at peak THC level for each of the two drugs up to 4 hours.|||Z score||Standard Deviation|Mean
798524|NCT00946478|Primary|Cathelicidin mRNA Expression Levels in Adult Skin From Patients With AD|Delta-delta CT values were measured using RT-PCR of cathelicidin mRNA in human biopsy samples at baseline, and then 3 weeks after treatment with either pimecrolimus or placebo|3 weeks|||delta-delta ct units on PCR||Standard Error|Mean
798525|NCT00946530|Secondary|WASO (Wake After Sleep Onset)|WASO (Wake After Sleep Onset): the amount of time test subjects have spent awake after initially falling sleep and before they awaken for good.|2 weeks|||units on a scale (minutes)||Standard Deviation|Mean
798526|NCT00946530|Primary|Total Sleep Time|The amount of actual sleep time in a sleep episode.|2 weeks|dyads consisting of 1 AD patient and 1 caregiver||units on a scale (minutes)||Standard Deviation|Mean
798527|NCT00948389|Other Pre-specified|Number of Participants With Disease Progression at 12 Months|As measured by brain magnetic resonance imaging.|12 months|Treated participants||participants|||Number
798996|NCT00950963|Secondary|Number of CVD Patients With LDL Less Than 70 mg/dL.||18 months|Analysis was per intention to treat||Participants|||Number
798528|NCT00948389|Primary|Number of Participants With Worst Grade of Biochemistry Abnormality Per NCI CTCAE Version 3.0 Criteria|Grades (gr) 1=mild; gr2=moderate; gr3=severe; gr4=life-threatening. For details of NCI CTCAE laboratory values for each grade, please refer to http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm#ctc_30. Low Potassium=Hypokalemia, High Potassium=Hyperkalemia, Low Sodium=Hyponatremia, Low Calcium=Hypocalcemia, High Bilirubin=Hyperbilirubinemia, low phosphatase=Hypophosphatemia, Low Potassium=Hypokalemia.|Assessed at baseline, every 2 weeks during cycles 1-6 (6-week cycles), and every 6 weeks after 6 cycles. Median number of cycles = 1.0 (range: 1.0 - 7.0).|Treated participants||participants|||Number
798529|NCT00948389|Primary|Number of Participants With Worst Grade of Hematological Toxicity Per NCI CTCAE Version 3.0 Criteria|Neutrophils (neutropenia): Grade (gr)1 <LLN–1500/mm3; Gr2 <1500–1000/mm3; Gr3 <1000–500/mm3; Gr4 <500/mm3. Leukocytes (leukopenia): Gr1 <LLN–3000/mm3; Gr2 <3000–2000/mm3; Gr3 <2000–1000/mm3; Gr4 <1000/mm3. Lymphocytes (lymphocytopenia): Gr1 <LLN–800/mm3; Gr2 <800–500/mm3; Gr3 <500–200/mm3; Gr4 <200/mm3. Platelets (thrombocytopenia): Gr1 <LLN–75,000/mm3; Gr2 <75,000–50,000/mm3; Gr3 <50,000–25,000/mm3; Gr4 <25,000/mm3. Hemoglobin (anemia): Gr1 <LLN–10.0 g/dL; Gr2 <10.0–8.0 g/dL; Gr3 <8.0–6.5 g/dL; Gr4 <6.5 g/dL. LLN/ULN=lower/upper limit of normal (normal ranges may vary by local laboratories).|Assessed at baseline, every 2 weeks during cycles 1-6 (6-week cycles), and every 6 weeks after cycle 6. Median number of cycles = 1.0 (range: 1.0 - 7.0).|Treated participants||participants|||Number
798530|NCT00948389|Primary|Deaths Within 30 Days of Protocol Treatment Discontinuation||From time of randomization through within 30 days after protocol treatment discontinuation. Median (full range) number of 6-week treatment cycles was 1.0 (1.0-7.0).|Treated participants||participants|||Number
798531|NCT00948389|Primary|Number of Participants With Dose-limiting Toxicities (DLTs)|Grades (gr) according to National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. DLTs were defined as adverse drug reactions as follows: absolute neutrophil counts <0.5x10^9/L (gr4) lasting for 7 consecutive days; febrile neutropenia (neutrophil count <1x10^9/L and fever of >=38.5°C); thrombocytopenia (gr4); any gr3/4 nonhematological toxicity except nausea, vomiting and fever which could be rapidly controlled with appropriate measures; any toxicity which did not allow administering at least 70% of the intended dose intensity for both agents.|The duration for observation of DLT was 2 6-week cycles in participants with escalated dose (QD to BID) and 1 6 -week cycle for participants starting with BID regime. For participants receiving dasatinib at 150 mg, DLTs were only documented over cycle 1.|Evaluable Participants: subset of participants used to decide on dose escalations. Participants were assessable if they completed the period for DLT observation.||participants|||Number
798532|NCT00948389|Primary|Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs|SAE=any untoward medical event that results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires inpatient hospitalization or prolongation. AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. Treatment-related(Tx-R)=certainly, probably, possibly related and unknown relationship to study drug. AE grades(Gr) 1=Mild; 2=Moderate; 3=Severe; 4=Life-threatening.|Assessed at baseline, every 2 weeks during cycles 1-6 (6-week cycles), and every 6 weeks after cycle 6. Median number of cycles = 1.0 (range: 1.0 - 7.0).|All treated participants||participants|||Number
798533|NCT00948441|Secondary|Safety, Side Effects|collection of adverse events and safety information. Each participant was contacted either at a clinical visit or by phone every two weeks while enrolled in the study.|7 months per study patient|collected adverse events during each time period||participants|||Number
798534|NCT00948441|Primary|Number of Episodes of Catheter Related Blood Stream Infections in Each Study Period.|For the purpose of this study, episodes of catheter related blood stream infections were considered as the primary outcome measure. An episode of infection was defined as more than one positive blood culture obtained from the catheter requiring antibiotic therapy. Each episode after enrollment was recorded in its appropriate study period: ethanol lock, placebo lock, or washout period. If a patient had a catheter related blood stream infections, the study locks were held until after the number of days in each period was calculated as the number of days not on antibiotic therapy.|7 months per study patient|This was a crossover study. Each participant served as their own control. Infections in each time period of the study were compared. Infections with using ethanol locks and infections while using heparin locks.||number of CRBSI per 1000 catheter days|||Number
798535|NCT00948506|Secondary|Subject-reported Adverse Events or Abnormal Findings|Number of participants who reported an adverse event (as assessed by subject interview and if indicated, physical exam) or had abnormal finding on urine and blood laboratory examination|up to 16 weeks|The analysis was performed using intention-to-treat, whereby all enrolled participants who received treatment were analyzed.||participants|||Number
798536|NCT00948506|Primary|Physician's Global Assessment (PGA) of Hair Density|Number of participants with a score of 2 or less on the Physician Global Assessment (PGA) of Hair Density at the end of active treatment. The five point scale ranges from 0 (total alopecia) to 5 (very dense).|up to 8 weeks or end of active treatment|The analysis was performed using intention-to-treat and all enrolled participants who received treatment were included in the analysis. For participants who withdrew during treatment, the data from their last visit were carried forward.||participants|||Number
798537|NCT00948610|Secondary|Cellular Inflammation|Percentage of monocytes producing interleukin-6 at post-infusion day 2 in placebo vs. remicade|Post-infusion day 2|||percentage of monocytes||Standard Deviation|Mean
798538|NCT00948610|Primary|Slow Wave Sleep|Slow wave sleep in minutes at post-infusion day 2 in placebo vs. remicade|Post-infusion day 2|||Minutes||Standard Deviation|Mean
798568|NCT00948818|Secondary|12-Week Stool Consistency|"The consistency of each BM was assessed by patients using the 7-point Bristol Stool Form Scale (BSFS) from 1 to 7.
= separate hard lumps like nuts [difficult to pass]
= sausage shaped but lumpy
= like a sausage but with cracks on surface
= like a sausage or snake, smooth and soft
= soft blobs with clear-cut edges [passed easily]
= fluffy pieces with ragged edges, a mushy stool
= watery, no solid pieces [entirely liquid])."|Change from Baseline to Week 12|802 randomized patients received study drug. The 800 patients in the ITT population had at least 1 postrandomization entry of the primary efficacy assessment; 107 patients with no pretreatment spontaneous bowel movements were excluded from the 12-Week Stool Consistency analysis. An observed-cases approach to missing postbaseline data was applied.||units on a scale||Standard Error|Least Squares Mean
798539|NCT00948675|Secondary|Disease Control Rates Defined as Complete Response (CR), Partial Response (PR), and Stable Disease (SD)|Disease control rate is the percentage of participants with a confirmed CR, PR or SD, as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. CR is the disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesion; SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Disease control rate is calculated as a total number of participants with CR or PR or SD divided by the total number of participants treated, then multiplied by 100.|Baseline to date of objective progressive disease up to 39.49 months|All randomized participants.||percentage of participants||95% Confidence Interval|Number
798540|NCT00948675|Secondary|Percentage of Participants With Complete Response or Partial Response (Overall Tumor Response Rate)|Overall Response rate (ORR) is the percentage of participants with a confirmed complete response (CR) or partial response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. CR is the disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesions. ORR is calculated as a total number of participants with CR or PR from the start of study treatment until disease progression or recurrence divided by the total number of participants treated, then multiplied by 100.|Baseline to date of objective progressive disease up to 39.49 months|All randomized participants.||percentage of participants||95% Confidence Interval|Number
798541|NCT00948675|Secondary|Overall Survival (OS)|OS is defined as the duration from the date of randomization to the date of death from any cause. For participants who were alive at the time of the data inclusion cutoff, OS was censored at the last date the participant was known to be alive.|Randomization to date of death from any cause up to 39.49 months|All randomized participants. The number of participants censored was 52 for pemetrexed + carboplatin group and 56 for paclitaxel + carboplatin + bevacizumab group.||months||90% Confidence Interval|Median
798542|NCT00948675|Secondary|Progression Free Survival (PFS)|PFS was defined as the duration from the date of randomization to the date of progressive disease (PD) or death from any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. PD is ≥20% increase in sum of longest diameter of target lesions or the appearance of new lesions. For participants who had no PD or death at the time of the data inclusion cutoff, PFS was censored at their last objective progression-free disease assessment prior to the cutoff date or the date of initiation of subsequent systemic anticancer therapy.|Randomization to measured progressive disease up to 39.49 months|All randomized participants. The number of participants censored was 35 for pemetrexed + carboplatin group and 49 for paclitaxel + carboplatin + bevacizumab group.||months||90% Confidence Interval|Median
798543|NCT00948675|Primary|Progression Free Survival Without Grade 4 Toxicity (G4PFS) as Measured by the Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0|G4PFS was defined as the duration from the date of randomization to the earliest occurrence date of one of the following three events: Common Terminology Criteria (CTC) grade 4 adverse events (G4AEs), or progressive disease (PD) or death from any cause, whichever occurred earlier. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. PD is ≥20% increase in sum of longest diameter of target lesions or the appearance of new lesions. For participants who had no G4AEs, or PD, or death at the time of the data inclusion cutoff, PFS was censored at their last objective progression-free disease assessment prior to the cutoff date or the date of initiation of subsequent systemic anticancer therapy.|Randomization to measured progressive disease or treatment discontinuation up to 39.49 months|All randomized participants. The number of participants censored was 30 for pemetrexed + carboplatin group and 35 for paclitaxel + carboplatin + bevacizumab group.||months||90% Confidence Interval|Median
798544|NCT00948688|Secondary|Resectability Rate|Percentage of patients able to undergo surgical resection after protocol therapy.|5 months|One participant excluded from this analysis due to non-compliance with study drug administration.||Participants|||Count of Participants
798545|NCT00948688|Secondary|Response Rate|Participants who have either a complete response (disappearance of all target lesions), partial response (at least 30% decrease in sum of longest diameter of target lesions) or stable disease (decrease in size of less than 30% or increase in size of less than 20%).|1 year|One participant excluded from this analysis due to non-compliance with study drug administration.||Participants|||Count of Participants
798546|NCT00948688|Secondary|Overall Survival|Percentage of participants still alive at 1 year after enrollment on study|1 year|One participant excluded from this analysis due to non-compliance with study drug administration.||Participants|||Count of Participants
798547|NCT00948688|Secondary|Number of Participants Experiencing Unacceptable Toxicity|All participants who receive at least one dose of study treatment were evaluable for toxicity. Unacceptable toxicity is based on the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Most grade 3 (severe) or 4 (life-threatening) events are considered to be unacceptable toxicities -- exceptions include nausea or vomiting, fatigue, and alopecia. Hematologic toxicities need to be either grade 4 or last for protocol-defined durations to be considered unacceptable.|1 year|||Participants|||Count of Participants
798548|NCT00948688|Secondary|Progression Free Survival|Progression free survival for this endpoint was defined as the duration of time from beginning of the patients' initial chemotherapy to time of objective disease progression. Death was regarded as a progression event. Progression was defined by the Response Evaluation Criteria in Solid Tumors (RECIST) as at least a 20% increase in the sum of the longest diameter of target lesions, or the appearance of one or more new lesions as seen on radiologic evaluation.|2 years|||months||95% Confidence Interval|Median
798549|NCT00948688|Primary|Progression Free Survival (PFS) at 7 Months From Registration|Progression free survival was defined as the duration of time from registration on study to time of objective disease progression. Death was regarded as a progression event. Progression was defined by the Response Evaluation Criteria in Solid Tumors (RECIST) as at least a 20% increase in the sum of the longest diameter of target lesions, or the appearance of one or more new lesions as seen on radiologic evaluation.|7 months|||months||95% Confidence Interval|Median
798550|NCT00948688|Primary|Maximally Tolerated Dose (MTD) of Vorinostat in Combination With Infusional 5-FU and Radiation Therapy.|The maximum tolerated dose (MTD) is defined as one dose level below the dose level at which participants experience an unacceptable rate of dose-limiting toxicity.|6 weeks|||milligrams per day|||Number
798551|NCT00948766|Secondary|Extension Study: Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Score at Week 24|The ADCS-CGIC assesses the clinical meaningfulness of a treatment based on the clinician’s rating of change. The rating is provided by a trained clinician or psychometrician blinded to the patient’s treatment. The rater interviewed the patient and caregiver separately at Baseline using a worksheet that provided space for notes and comments. At baseline, raters had access to all of the patient’s available records and evaluations. The rater used a similar worksheet at follow-up visits, and referred to the baseline worksheet prior to making a rating of change. The worksheets were divided into 3 domains: mental/cognitive state, behavior, and functioning. Change ratings were based on a 7-point scale: Marked (1), moderate (2), and minimal improvement (3), no change (4), and marked (5), moderate (6), and minimal worsening (7). The percentage of patients in each of the 7 categories is reported.|Baseline of the core study to Week 24 of the extension study|Modified full analysis set: All patients who received at least 1 application of study medication and had at least 1 efficacy assessment in the extension study. Only patients with available data were included in the analysis.||Percentage of patients|||Number
798552|NCT00948766|Secondary|Extension Study: Change From Baseline in the Severity Impairment Battery (SIB) Score at Week 24|The SIB is a 40-item scale developed for the evaluation of the severity of cognitive dysfunction in more advanced Alzheimer Disease patients. The domains assessed included social interaction, memory, language, attention, orientation, praxis, visuo-spatial ability, construction, and orienting to name. The items of the SIB were developed as simple 1-step commands which are presented by a trained rater with gestural cues and repeated if necessary. The SIB was scored from 0 to 100, with higher scores reflecting higher levels of cognitive ability. A positive change score indicates improvement.|Baseline of the core study to Week 24 of the extension study|Modified full analysis set: All patients who received at least 1 application of study medication and had at least 1 efficacy assessment in the extension study. Only patients with available data were included in the analysis.||Units on a scale||Standard Deviation|Mean
798553|NCT00948766|Secondary|Extension Study: Change From Baseline in the Alzheimer's Disease Cooperative Study-Activities of Daily Living-Severe Impairment Version (ADCS-ADL-SIV) Score at Week 24|"The ADCS-ADL-SIV is designed to assess the patient's performance of both basic and instrumental activities of daily living such as those necessary for personal care, communicating and interacting with other people, maintaining a household, conducting hobbies and interests, and making judgments and decisions. For each of the 19 questions in the ADCS-ADL-SIV, there was either a forced choice of best response or a yes or no question with additional sub-questions. Responses for each item were obtained from the caregiver through an interview. Higher numbered scores and answers of yes reflected a more self-sufficient individual. The total score was calculated as the sum of all items and sub-questions and ranged from 0 to 54. A higher total score represented a higher functioning patient. A positive change score indicates improvement."|Baseline of the core study to Week 24 of the extension study|Modified full analysis set: All patients who received at least 1 application of study medication and had at least 1 efficacy assessment in the extension study. Only patients with available data were included in the analysis.||Units on a scale||Standard Deviation|Mean
798554|NCT00948766|Secondary|Core Study: Change From Baseline in the Neuropsychiatric Inventory (NPI-12) Score at Week 24|The NPI-12 assesses a wide range of behaviors encountered in patients with dementia to provide a means of distinguishing the frequency and severity of behavioral changes over time. Ten behavioral and 2 neurovegetative domains were evaluated in an interview with the caregiver given by a mental health professional. The scale included both frequency and severity ratings of each domain as well as a composite domain score (frequency x severity). The sum of the composite scores for the 12 domains yielded the NPI-12 total score. The NPI-12 was scored from 0 to 144, with lower scores reflecting improvement in psychiatric behavior. A negative change score indicates improvement.|Baseline of the core study to Week 24 of the core study|Modified full analysis set: All randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline measurement of the co-primary efficacy variables. Only patients with available data were included in the analysis.||Units on a scale||Standard Deviation|Mean
798555|NCT00948766|Secondary|Core Study: Alzheimer’s Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Score at Week 24|The ADCS-CGIC assesses the clinical meaningfulness of a treatment based on the clinician’s rating of change. The rating is provided by a trained clinician or psychometrician blinded to the patient’s treatment. The rater interviewed the patient and caregiver separately at Baseline using a worksheet that provided space for notes and comments. At baseline, raters had access to all of the patient’s available records and evaluations. The rater used a similar worksheet at follow-up visits, and referred to the baseline worksheet prior to making a rating of change. The worksheets were divided into 3 domains: mental/cognitive state, behavior, and functioning. Change ratings were based on a 7-point scale: Marked (1), moderate (2), and minimal improvement (3), no change (4), and marked (5), moderate (6), and minimal worsening (7). The percentage of patients in each of the 7 categories is reported.|Baseline of the core study to Week 24 of the core study|Modified full analysis set: All randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline measurement of the co-primary efficacy variables. Only patients with available data were included in the analysis.||Percentage of patients|||Number
798556|NCT00948766|Primary|Core Study: Change From Baseline in the Severity Impairment Battery (SIB) Score at Week 24|The SIB is a 40-item scale developed for the evaluation of the severity of cognitive dysfunction in more advanced Alzheimer Disease patients. The domains assessed included social interaction, memory, language, attention, orientation, praxis, visuo-spatial ability, construction, and orienting to name. The items of the SIB were developed as simple 1-step commands which are presented by a trained rater with gestural cues and repeated if necessary. The SIB was scored from 0 to 100, with higher scores reflecting higher levels of cognitive ability. A positive change score indicates improvement.|Baseline of the core study to Week 24 of the core study|Modified full analysis set: All randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline measurement of the co-primary efficacy variables. Only patients with available data were included in the analysis.||Units on a scale||Standard Deviation|Mean
798587|NCT00949078|Primary|Dose of Peanut Protein Inducing Allergic Symptoms at OFC 2|mg|up to 8 weeks|||mg||Full Range|Median
798588|NCT00949078|Primary|Dose of Peanut Protein Inducing Allergic Symptoms at Oral Food Challenge (OFC) 1|mg|up to 8 weeks|||mg||Full Range|Median
798589|NCT00949078|Primary|Total Immunoglobulin E (IgE) After Pn-BHR Response|kU/L (range)|up to 6 months|||kU/L||Full Range|Median
798557|NCT00948766|Primary|Core Study: Change From Baseline in the Alzheimer’s Disease Cooperative Study-Activities of Daily Living-Severe Impairment Version (ADCS-ADL-SIV) Score at Week 24|"The ADCS-ADL-SIV is designed to assess the patient's performance of both basic and instrumental activities of daily living such as those necessary for personal care, communicating and interacting with other people, maintaining a household, conducting hobbies and interests, and making judgments and decisions. For each of the 19 questions in the ADCS-ADL-SIV, there was either a forced choice of best response or a yes or no question with additional sub-questions. Responses for each item were obtained from the caregiver through an interview. Higher numbered scores and answers of yes reflected a more self-sufficient individual. The total score was calculated as the sum of all items and sub-questions and ranged from 0 to 54. A higher total score represented a higher functioning patient. A positive change score indicates improvement."|Baseline of the core study to Week 24 of the core study|Modified full analysis set: All randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline measurement of the co-primary efficacy variables. Only patients with available data were included in the analysis.||Units on a scale||Standard Deviation|Mean
798558|NCT00948792|Primary|30 Minute-6 Hour Difference in Platelet Counts||30 minutes - 6 hours after transfusion|Transfusions were randomized, not babies. Therefore, each baby could provide transfusions falling into either arm of randomization. The 21 long transfusions were provided by 14 infants; the 22 short transfusions by 15. This explains the perceived discrepancy.||Platelets (*10^3/mm^3)|Participants|Full Range|Median
798559|NCT00948792|Primary|Change in Post-transfusion Platelet Counts|The difference between the baseline platelet count and the platelet count taken 6 hours after completion of the transfusion.|Baseline - 6 hours after transfusion|Transfusions were randomized, not babies. Therefore, each baby could provide transfusions falling into either arm of randomization. The 21 long transfusions were provided by 14 infants; the 22 short transfusions by 15. This explains the perceived discrepancy.||Platelets (*10^3/mm^3)|Participants|Full Range|Median
798560|NCT00948792|Primary|Change in Post-transfusion Platelet Counts|The difference between the baseline platelet count and the platelet count taken 30 minutes after completion of the transfusion.|Baseline-30 minutes after transfusion|Transfusions were randomized, not babies. Therefore, each baby could provide transfusions falling into either arm of randomization. The 21 long transfusions were provided by 14 infants; the 22 short transfusions by 15. This explains the perceived discrepancy.||Platelets (*10^3/mm^3)|Participants|Full Range|Median
798561|NCT00948818|Secondary|12-Week Percent of Abdominal Pain-free (APF) Days|"Abdominal pain free (APF) days are those days where the patient reported a score of ‘0’ for abdominal pain at its worst
Abdominal Pain at its worst (in the last 24 hours) is based on an 11-point scale where 0 represents no abdominal pain and 10 represents very severe abdominal pain."|Change from Baseline to Week 12|803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.||Percent||Standard Deviation|Mean
798562|NCT00948818|Secondary|Abdominal Pain Responder for 6 Out of 12 Weeks|"A patient is considered to be an abdominal pain responder if, for at least 6 out of the 12 weeks of the treatment period, they experienced a decrease of 30 percent or more in the abdominal pain score from baseline.
The Abdominal Pain score assesses the worst of a patient's abdominal pain in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no abdominal pain and 10 represents very severe abdominal pain."|Change from Baseline to Week 12|803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.||Participants|||Number
798563|NCT00948818|Secondary|Complete Spontaneous Bowl Movement (CSBM) Responder for 6 Weeks Out of 12 Weeks of Treatment|A patient is considered to be a CSBM responder if, for at least 6 out of the 12 weeks of the treatment period, an increase of at least 1 CSBM per week from baseline was experienced.|Change from Baseline to Week 12|803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.||Participants|||Number
798564|NCT00948818|Secondary|12-Week Change in Bloating|Bloating was assessed on an 11-point scale where a value of 0 is “none” and a value of 10 is “very severe”.|Change from Baseline to Week 12|803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.||units on a scale||Standard Error|Least Squares Mean
798565|NCT00948818|Secondary|12-Week Change in Abdominal Discomfort|Abdominal Discomfort is measured on an 11-point scale where a value of 0 is “none” and a value of 10 is “very severe.”|Change from Baseline to Week 12|803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.||units on a scale||Standard Error|Least Squares Mean
798566|NCT00948818|Secondary|12-Week Change in Abdominal Pain Score|Abdominal Pain at its worst (in the last 24 hours) is based on an 11-point scale where 0 represents no abdominal pain and 10 represents very severe abdominal pain.|Change from Baseline to Week 12|803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.||units on a scale||Standard Error|Least Squares Mean
798567|NCT00948818|Secondary|12-Week Severity of Straining|Straining is measured on a 5-point scale where a value of 1 is “not at all” and a value of 5 is “an extreme amount.|Change from Baseline to Week 12|802 randomized patients received study drug. The 800 patients in the ITT population had at least 1 postrandomization entry of the primary efficacy assessment; 107 patients with no pretreatment spontaneous bowel movements were excluded from the Severity of Straining analysis. An observed-cases approach to missing postbaseline data was applied.||units on a scale||Standard Error|Least Squares Mean
798590|NCT00949078|Primary|Peanut Specific Immunoglobulin E (IgE) After Pn-BHR Response|kU/L (range)|up to 6 months|||kU/L||Full Range|Median
798569|NCT00948818|Secondary|12-Week Spontaneous Bowl Movement (SBM) Frequency Rate|The number of Spontaneous Bowl Movements experienced per week.|Change from Baseline to Week 12|803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.||SBMs per week||Standard Error|Least Squares Mean
798570|NCT00948818|Primary|Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 6 Out of 12 Weeks.|"A patient is considered an APC responder if, for at least 6 of the 12 weeks of the treatment, the patient experienced an increase of at least 1 Complete Spontaneous Bowel Movement (CSBM) from baseline and experienced a decrease of at least 30 percent in their Abdominal Pain (AP)score during a particular week.
The AP score assesses the worst of a patient's AP in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no AP and 10 represents very severe AP.
A CSBM was defined as a Spontaneous Bowel Movement (SBM) that was associated with a sense of complete evacuation."|Change from Baseline to Week 12|803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.||Participants|||Number
798571|NCT00948818|Primary|Abdominal Pain Responder, 9 Out of 12 Weeks|"A patient is considered to be an abdominal pain responder if, for at least 9 out of the 12 weeks of the treatment period, they experienced a decrease of at least 30 percent in the mean abdominal pain score from baseline during a particular week.
The Abdominal Pain score assesses the worst of a patient's abdominal pain in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no abdominal pain and 10 represents very severe abdominal pain."|Change from Baseline to Week 12|803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.||Participants|||Number
798572|NCT00948818|Primary|Complete Spontaneous Bowel Movement (CSBM) 3+1 Responder, 9 Out of 12 Weeks|"A patient is considered to be a CSBM 3+1 responder if, for at least 9 out of the 12 weeks of the treatment period, the patient had at least 3 CSBMs and experienced an increase of at least 1 CSBM from baseline during a particular week.
A CSBM was defined as a Spontaneous Bowel Movement (SBM) that was associated with a sense of complete evacuation.
An SBM was defined as a bowel movement (BM) that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM."|Change from Baseline to Week 12|803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.||Participant|||Number
798573|NCT00948818|Secondary|12-Week Complete Spontaneous Bowel Movement (CSBM) Frequency Rate|The number of CSBMs per week.|Change from Baseline to Week 12|803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.||CSBMs per Week||Standard Error|Least Squares Mean
798574|NCT00948818|Primary|Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 9 Out of 12 Weeks|"A patient is considered to be an APC responder if, for at least 9 out of the 12 weeks of the treatment period, the patient had at least 3 CSBMs, experienced an increase of at least 1 CSBM from baseline, and experienced a decrease of at least 30 percent in their Abdominal Pain (AP) score from baseline during a particular week.
The AP score assesses the worst of a patient's AP in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no AP and 10 represents very severe AP.
A CSBM is defined as a spontaneous bowel movement, associated with a sense of complete evacuation."|Change from Baseline to Week 12|803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the Intent to Treat (ITT) Population. An observed-cases approach to missing postbaseline data was applied.||Participants|||Number
798575|NCT00948857|Primary|Live Birth|Live Birth outcome compared between DHEA active treatment and Placebo|9 months|This study was closed for futility because of difficulty finding patients willing to undergo randomization.||participants|||Number
798576|NCT00948857|Secondary|Clinical Pregnancy||12 months||||||
798577|NCT00948857|Secondary|Androgen Side Effects||12 months||||||
798578|NCT00948857|Secondary|Endocrine Effects||12 months||||||
798579|NCT00948857|Primary|Live Birth||24 months||||||
798580|NCT00948896|Primary|Incident Malaria Cases Per Person Year at Risk in HIV-exposed Participants|The primary outcome was the incidence of malaria, defined as the number of incident episodes per time at risk, during the period the intervention was given. Treatments within 14 days of a prior episode were not considered incident events. Time at risk was from the day following the initiation of study drugs to the last day of observation, minus 14 days after each treatment for malaria.|Randomization to 24 months of age|||Episodes per person year at risk|||Number
798581|NCT00948896|Primary|Incident Malaria Cases Per Person Year at Risk in HIV-unexposed Participants|The incidence of malaria, defined as the number of incident episodes per time at risk, during the period the intervention was given (6–24 mo of age). Treatments within 14d of a prior episode were not considered incident events. Time at risk was from the day following the initiation of study drugs to the last day of observation, minus 14 d after each treatment for malaria.|6 to 24 months of age|||Episode per person year at risk|||Number
798582|NCT00948896|Secondary|Rebound Incidence of Malaria Defined as the Number of Treatments for New Episodes of Malaria Per Time at Risk||24 months to 36 months of age|||Incidence per person year at risk|||Number
798583|NCT00948896|Secondary|Incidence of Any Adverse Events Defined as Severity Grade 3-4 That Are Possibly, Probably, or Definitely Related to Study Drugs|NIH Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events published December, 2004|Time from randomization until 24 months of age|||incidence per person-year at risk|||Number
798584|NCT00949078|Primary|Omalizumab Received Before OFC 2|total mg|up to 6 months|||mg||Full Range|Median
798585|NCT00949078|Primary|Omalizumab Received Before OFC 2|Number of doses|up to 6 months|||number of doses||Full Range|Median
798586|NCT00949078|Primary|Dose of Peanut Protein Inducing Allergic Symptoms at OFC 3|mg|up to 8 weeks|||mg||Full Range|Median
798593|NCT00949117|Secondary|Change in Weight for Age Z-score From Baseline Through 24 Weeks|Change in weight for age Z-score from Baseline through 24 weeks while on study treatment. Weight for age Z-score calculated using the Center for Disease Control and Prevention (CDC) weight-for-age Z score data tables.|Baseline and 24 weeks|||z score||Standard Deviation|Mean
798594|NCT00949117|Secondary|Quality of Life as Assessed by Peds-FAACT Questionnaire at Baseline and at Weeks 4 and 24||24 weeks|Outcome not assessed as the one subject that completed the protocol was too young to complete the PedsFAACT quality of life assessment.|||||
798595|NCT00949117|Secondary|Effect of Cyproheptadine Hydrochloride on Pre-albumin and Body Composition||24 weeks|Outcome not assessed as the one subject that completed the protocol did not have the prealbumin lab drawn at the 24 week visit and body composition tests assessed.|||||
798596|NCT00949117|Secondary|Body Mass Index as Assessed at Baseline and 24 Weeks|Change in Body Mass Index (BMI) in subjects from Baseline visit to 24 week visit.|24 weeks|||kg/m^2||Standard Deviation|Mean
798597|NCT00949117|Primary|Difference Between Measures of Weight at Baseline and at Week 24|Difference in measure of weight in kilograms of subject at baseline and at week 24 after continuing on study treatment for the entire 24 week period.|24 weeks|||kilograms||Standard Deviation|Mean
798598|NCT00949533|Secondary|Number of Participants With Various Clinical Signs and Symptoms in Whom Resistant Virus Were Detected|Number of participants with various clinical signs and symptoms, as per investigator's discretion, in whom new AH1N1 virus was detected, were reported. Same participants were reported in more than 1 category.|Day 5|"ITT population. Here number of participants analyzed included evaluable participants for the outcome measure."||participants|||Number
798599|NCT00949533|Secondary|Number of Participants With Various Clinical Signs and Symptoms|"Number of participants with various clinical signs and symptoms, as per investigator's discretion, were reported. Same participants were reported in more than 1 category. Other in the category included abdominal pain, breathlessness, thoracic pain and tired."|Day 5|"ITT population. Here number of participants analyzed included evaluable participants for the outcome measure."||participants|||Number
798600|NCT00949533|Secondary|Percentage of Participants With A Reduction in Viral Load|Viral load is defined as the amount of H1N1 virus in blood. As per investigator, a participant was considered as having viral load reduction at Day 5 if the Day 5 viral load was lower than the Baseline viral load.|Baseline, Day 5|ITT population.||percentage of participants|||Number
798601|NCT00949533|Primary|Percentage of Participants Excreting Resistant Virus|Resistant virus included new influenza A virus subtype hemagglutinin type 1 and neuraminidase type 1 (New AH1N1).|Day 5|"ITT population. Here number of participants analyzed included evaluable participants for the outcome measure."||percentage of participants|||Number
798602|NCT00949650|Secondary|Trough Plasma Concentrations of Afatinib at Day 43|Trough plasma concentrations of afatinib at day 43 (course 3, visit 1) after multiple daily dosing of 40mg afatinib and after dose escalation to 50 mg or dose reduction to 30mg or 20mg.|Day 43|Patients from the treated set with evaluable data and who had at least 1 valid afatinib plasma concentration available on this time point.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
798603|NCT00949650|Secondary|Trough Plasma Concentrations of Afatinib at Day 29|Trough plasma concentrations of afatinib at day 29 (course 2, visit 2) after multiple daily dosing of 40mg afatinib and after dose escalation to 50 mg or dose reduction to 30mg or 20mg.|Day 29|Patients from the treated set with evaluable data and who had at least 1 valid afatinib plasma concentration available on this time point.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
798604|NCT00949650|Secondary|Trough Plasma Concentrations of Afatinib at Day 22|Trough plasma concentrations of afatinib at day 22 (course 2, visit 1) after multiple daily dosing of 40mg afatinib and after dose escalation to 50 mg or dose reduction to 30mg or 20mg.|Day 22|Patients from the treated set with evaluable data and who had at least 1 valid afatinib plasma concentration available on this time point.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
798605|NCT00949650|Secondary|HRQOL: Time to Deterioration in Pain|HRQOL was measured by EORTC QLQ-C30 and its lung cancerspecific module QLQ-LC13. Analysis for pain is based on composite of QLQ-C30 questions 9 and 19. Time to deterioration was defined as the time from randomisation to a score increased (worsened) by at least 10 points from baseline (0-100 point scale). Patients were considered deteriorated at time of death. Median time results from unstratified Kaplan-Meier estimates.|Throughout the trial until progression (every 3 weeks)|RS||months||95% Confidence Interval|Median
798606|NCT00949650|Secondary|HRQOL: Time to Deterioration in Dyspnoea|HRQOL was measured by EORTC QLQ-C30 and its lung cancerspecific module QLQ-LC13. Analysis for dyspnoea is based on composite of QLQ-LC13 questions 3-5. Time to deterioration was defined as the time from randomisation to a score increased (worsened) by at least 10 points from baseline (0-100 point scale). Patients were considered deteriorated at time of death. Median time results from unstratified Kaplan-Meier estimates.|Throughout the trial until progression (every 3 weeks)|RS||months||95% Confidence Interval|Median
798607|NCT00949650|Secondary|Health Related Quality of Life (HRQOL): Time to Deterioration in Coughing|HRQOL was measured by European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire C30 (QLQ-C30) and its lung cancerspecific module LC13 (QLQ-LC13). Analysis for cough is based on QLQ-LC13 question 1. Time to deterioration was defined as the time from randomisation to a score increased (worsened) by at least 10 points from baseline (0-100 point scale). Patients were considered deteriorated at time of death. Median time results from unstratified Kaplan-Meier estimates.|Throughout the trial until progression (every 3 weeks)|RS.||months||95% Confidence Interval|Median
798608|NCT00949650|Secondary|Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)|ECOG PS measured on 6 point scale to assess participants performance status. 0=Fully active, able to carry on all pre-disease activities without restriction; 1=Restricted in physically strenuous activity, but ambulatory and able to carry out light or sedentary work; 2=Ambulatory (>50 percent of waking hours), capable of all selfcare, unable to carry out any work activities; 3=Capable of only limited self care, confined to bed or chair more then 50 percent of waking hours; 4=Completely disabled, cannot carry on any selfcare, totally confined to bed or chair; 5=Dead.|Throughout the trial until progression (every 3 weeks), up to 28 month|RS. Only patients with baseline and at least one post-baseline assessment were included.||Participants|||Number
798997|NCT00950963|Primary|Number of Patients With a Low Density Lipid (LDL) Value Less Than 100 mg/dL|Number of patients with and without cardiovascular disease (CVD) with LDL value less than 100 mg/dL at the end of the study|18 months|Analysis was per intention to treat.||Participants|||Number
798609|NCT00949650|Secondary|Change From Baseline in Body Weight|Because the PFS was longer for patients in the afatinib arm than for patients in the chemotherapy arm, the period of data collection for ECOG status and body weight continued for a longer time in the afatinib arm.|Baseline and throughout the trial until progression (every 3 weeks), up to 28 month|RS. Only patients with baseline and at least one post-baseline assessment were included.||kg||Standard Deviation|Mean
798610|NCT00949650|Secondary|Tumour Shrinkage|Tumour shrinkage is calculated as the minimum sum of diameters (SoD) of target lesions from all post-baseline tumour assessments, as read by the central independent review. The mean of these minimum values are presented after adjusting for baseline SoD, EGFR mutation group and race.|Tumour assessments were performed at screening, Week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks|RS. There were only 204 patients in the Afatinib 40 mg arm and 100 patients in the Pemetrexed / Cisplatin Chemotherapy with tumour measurements.||mm||Standard Error|Mean
798611|NCT00949650|Secondary|Overall Survival (OS) Time|OS is defined as time from randomisation to death.|From randomisation to primary endpoint analysis cut-off date.|RS.||months||95% Confidence Interval|Median
798612|NCT00949650|Secondary|Percentage of Participants With Disease Control (DC)|DC is defined as a patient with OR or stable disease (SD). Assessed by central independent review according to the RECIST 1.1. Only data collected until the primary endpoint analysis cut-off date were considered.|Tumour assessments were performed at screening, Week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks|RS||Percentage of Participants with DC||95% Confidence Interval|Number
798613|NCT00949650|Secondary|Percentage of Patients With Objective Response (OR)|OR is defined as complete response (CR) and partial response (PR). Assessed by central independent review according to RECIST 1.1. Only data collected until the primary endpoint analysis cut-off date (09 February 2012) were considered.|Tumour assessments were performed at screening, Week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks|RS||Percentage of patients with OR||95% Confidence Interval|Number
798614|NCT00949650|Primary|Progression-free Survival (PFS) Time|PFS is defined as time from randomisation to disease progression or death whichever occurs first. Assessed by central independent review according to the Response Evaluation Criteria in Solid Tumours (RECIST 1.1). Median time results from unstratified Kaplan-Meier estimates. Only data collected until the primary endpoint analysis cut-off date (09 February 2012) were considered.|Tumour assessments were performed at screening, Week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks or until death|Randomised Set (RS). The randomised set includes all patients who were randomised to receive treatment, whether treated or not.||months||95% Confidence Interval|Median
798615|NCT00949702|Secondary|Percentage of Patients With Adverse Event|The intensity of adverse events was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0 (CTCAE) on a 5-point scale (Grade 1 to 5: Mild, Moderate, Severe, Life-threatening, and Death).|From first treatment through September 27, 2010|Intent-to-treat population: All enrolled patients who received at least one, or a partial dose of vemurafenib.||Percentage of participants|||Number
798616|NCT00949702|Secondary|Time-matched Change From Baseline in the Study Specific Corrected QT Interval (QTcP)|Three electrocardiograms (ECG) were obtained pre-dose and 2, 4, 6, and 8 hours post-dose at Days 1 and 15 of Cycle 1 and again pre-dose and 4 hours post-dose at various Cycles throughout treatment. Five baseline triplicate ECGs were obtained before the start of treatment at the same time points used during treatment. Reported is the largest mean time-matched QTcP change from baseline. QTcP=QT/(60/heart rate)^β (β=mean [calculated separately for males and females] log-transformed QT versus log-transformed RR regression slopes using all available pre-treatment (baseline) ECG values.|Pre-dose Cycle 1 Day 1 to pre-dose Cycle 6 Day 1|Electrocardiogram (ECG) evaluable population: All treated patients who had a baseline ECG and at least one ECG during treatment.||ms||95% Confidence Interval|Mean
798617|NCT00949702|Secondary|Vemurafenib Plasma Levels at Various Treatment Cycles|Blood samples for assessing the concentration of vemurafenib in plasma were drawn before the morning dose and 4 hours post-dose at Day 1 of Cycles 1, 2, 3, 4, 6, 8, and 10. Each Cycle was 3 weeks in duration.|Pre-dose Cycle 1 Day 1 to 4 hours post-dose Cycle 10 Day 1|Pharmacokinetic population: All patients who received all doses of vemurafenib without dose reduction up to and including Day 15 and who provided at least one of the pharmacokinetic assessments up to and including 8 hours after the first daily dose on Day 15.||μg/mL||Standard Deviation|Mean
798618|NCT00949702|Secondary|Vemurafenib Plasma Level Area Under the Curve From 0 to 8 Hours (AUC0-8h) on Day 15 of Cycle 1|Blood samples for assessing the concentration of vemurafenib in plasma were drawn before the morning dose and at 2, 4, 6, and 8 hours post-dose on Day 15 of Cycle 1. Pharmacokinetic parameters were estimated by non-compartmental analysis (Win Non-Lin). AUC0-8h was calculated using the linear trapezoidal rule.|Pre-dose to 8 hours post-dose on Day 15 of Cycle 1|Pharmacokinetic population: All patients who received all doses of vemurafenib without dose reduction up to and including Day 15 and who provided at least one of the pharmacokinetic assessments up to and including 8 hours after the first daily dose on Day 15.||μg⋅h/mL||Standard Deviation|Mean
798619|NCT00949702|Secondary|Maximum Plasma Concentration (Cmax) of Vemurafenib on Day 15 of Cycle 1|Blood samples for assessing the concentration of vemurafenib in plasma were drawn before the morning dose and at 2, 4, 6, and 8 hours post-dose on Day 15 of Cycle 1. Pharmacokinetic parameters were estimated by non-compartmental analysis (Win Non-Lin).|Pre-dose to 8 hours post-dose on Day 15 of Cycle 1|Pharmacokinetic population: All patients who received all doses of vemurafenib without dose reduction up to and including Day 15 and who provided at least one of the pharmacokinetic assessments up to and including 8 hours after the first daily dose on Day 15.||μg/mL||Standard Deviation|Mean
798620|NCT00949702|Secondary|Improvement in Physical Symptoms (Improvement in Physician’s Assessment of Global Performance Status and Oxygen Saturation Requirements, and Decrease in Total Dose and Frequency of Narcotic Pain Analgesics) During Treatment in Comparison to Baseline|Three parameters were measured. (1) Improvement in the Physician’s Assessment of Global Performance status on a 7-point scale (1=very much better to 7=very much worse). (2) Improvement in oxygen saturation requirements, defined as a clinically meaningful increase in oxygen saturation requirement (from a baseline value < 95% to ≥ 95% saturation using a pulse oximeter). (3) A decrease in total dose and frequency of narcotic pain analgesics. The percentage of patients showing improvement (1 and 2) or a decrease (3) are reported.|From first treatment through September 27, 2010|Intent-to-treat population: All enrolled patients who received at least one, or a partial dose of vemurafenib.||Percentage of participants||95% Confidence Interval|Number
798621|NCT00949702|Secondary|Overall Survival|Overall survival was defined as the time from the date of the first treatment to the date of death, regardless of the cause of death. For patients who were alive at the time of analysis, overall survival was censored at the last date the patient was known to be alive prior to the data cutoff date.|From first treatment through September 27, 2010|Intent-to-treat population: All enrolled patients who received at least one, or a partial dose of vemurafenib.||Months||95% Confidence Interval|Median
798622|NCT00949702|Secondary|Progression Free Survival (PFS) Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)|PFS was defined the time interval between the date of the first treatment and the date of progression or death from any cause, whichever occurred first. Deaths that occurred in patients without disease progression were considered to be a PFS event on the date of death. Patients who neither progressed nor died were censored on the date of the last evaluable tumor assessment prior to the data cutoff date.|From first treatment through September 27, 2010|Intent-to-treat population: All enrolled patients who received at least one, or a partial dose of vemurafenib.||Months||95% Confidence Interval|Median
798623|NCT00949702|Secondary|Time to Response Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)|Time to response was defined as the interval between the date of the first treatment and the date of the first documentation of confirmed complete response (CR) or partial response (PR), whichever occurred first.|From first treatment through September 27, 2010|Intent-to-treat population: All enrolled patients who received at least one, or a partial dose of vemurafenib.||Months||Inter-Quartile Range|Median
798624|NCT00949702|Secondary|Duration of Response Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)|Duration of response was defined as the time interval between the date of the earliest qualifying response and the date of disease progression (PD) or death, only for those patients whose best overall response was complete response or partial response. PD: At least 20% increase in the sum of diameters of target lesions compared to Nadir (smallest sum of diameters on-study), unequivocal progression of existing non-target lesions, or presence of new lesion. For patients who were alive without progression, duration of response was censored on the date of the last evaluable tumor assessment.|From first treatment through September 27, 2010|Intent-to-treat population: All enrolled patients who received at least one, or a partial dose of vemurafenib.||Months||95% Confidence Interval|Median
798625|NCT00949702|Secondary|Best Overall Response (BOR) Assessed by the Investigator Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)|BOR was defined as a complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. Patients who never received study treatment and treated patients without any post-baseline tumor assessments were considered as non-responders. CR: Disappearance of all target lesions, all non-target lesions, and no new lesion. Any pathological lymph nodes must have had reduction in the short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesion.|From first treatment through September 27, 2010|Intent-to-treat population: All enrolled patients who received at least one, or a partial dose of vemurafenib.||Percentage of participants||95% Confidence Interval|Number
798626|NCT00949702|Primary|Best Overall Response (BOR) Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)|BOR was defined as a complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. Patients who never received study treatment and treated patients without any post-baseline tumor assessments were considered as non-responders. CR: Disappearance of all target lesions, all non-target lesions, and no new lesion. Any pathological lymph nodes must have had reduction in the short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesion.|From first treatment through September 27, 2010|Intent-to-treat population: All enrolled patients who received at least one, or a partial dose of vemurafenib.||Percentage of participants||95% Confidence Interval|Number
798627|NCT00949715|Secondary|Compare AT/AF Burden From Baseline to 24 Months Follow-up Between the Optimize RV Mid-Septal (RVS) and RV Apex (RVA) Groups.|Test the difference in AT/AF burden (defined as total duration of minutes in AT or AF relative to total patient follow-up days from baseline to 24 months follow-up) between the Optimize RVS and RVA groups. The proportion can be interpreted as the average time per day that patieents were in AT/AF as collected in the time period from baseline to 24 month follow-up.|Whole time from baseline to 24 months averaged by day|All subjects who meet inclusion/exclusion criteria for the study.||minutes per day||Standard Deviation|Mean
798628|NCT00949715|Secondary|Compare Change in LV End Systolic Volume After 24 Months Follow-up Between the Optimize RVS Group and RVA Group.|Compare change in 4 chamber LV end systolic volume between baseline and 24 month visit between the Optimize RVS group and RVA group.|24 months|All subjects who had 4 chamber LV end systolic volume at both the baseline and the 24 month time points||mL||95% Confidence Interval|Mean
798629|NCT00949715|Secondary|Compare the Change in LVEF From the 2 Week Visit (Collected in Prior Study) to the 24 Month Follow-up Visit Between the Optimize RV Mid-Septum Pacing (RVS) Group and RV Apical Pacing (RVA) Group.|Compare the change in LVEF (in the 4 chamber view) from 2 weeks to 24 months between the Optimize RV Mid-Septum Pacing (RVS) group and RV Apical Pacing (RVA) group.|24 months|Patients that had both 2 week and 24 month follow-up echo data with a 4 chamber LVEF measurement||percentage of LVEF||95% Confidence Interval|Mean
798630|NCT00949715|Primary|Difference in Mean Left Ventricular Ejection Fraction (LVEF) Between RV Pacing Sites at 24 Month|Difference in mean LVEF between pacing sites (RV mid-septal minus RV apex) at 24 months using the 4 chamber view|24 months|Subjects who had LVEF measurements from both baseline and 24 month timepoints||percentage of LVEF||95% Confidence Interval|Mean
798631|NCT00949884|Other Pre-specified|Change From Baseline to Week 2 in Trough, Cuff, Seated Blood Pressure|The change from baseline in trough systolic and diastolic blood pressure at Week 2 as measured by the Omron monitor. Morning doses of study medication were taken after the exam, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit.|Baseline, Week 2|The efficacy population was defined as participants who received at least 1 dose of double-blind randomized study medication and had a baseline and at least 1 post-baseline blood pressure measurement. Last observation carried forward.||mmHg||Standard Error|Least Squares Mean
798632|NCT00949884|Other Pre-specified|Change From Baseline in Mean Ambulatory Blood Pressure During the Final 2, 4, and 6 Hours of the Dosing Interval at Week 8|In week 8, participants arrived at the site in the morning without having taken that day's dose of medication. Once the ambulatory blood pressure monitor (ABPM) had been applied, medication was taken and the participant wore the ABPM for a period of 24-hours. Systolic and diastolic blood pressure readings taken in the final 2, 4, and 6 hours of the 24-hour ABPM cycle are summarized.|Baseline, Week 8|The ambulatory blood pressure monitor (ABPM) population was defined as participants in the efficacy population that had valid baseline and Week 8 ABPM data. Valid (technically successful) ABPM had at least 23 hours of ABPM data.||mmHg||Standard Error|Least Squares Mean
798633|NCT00949884|Other Pre-specified|Change From Baseline in Mean Ambulatory Blood Pressure During the Final 2, 4, and 6 Hours of the Dosing Interval at Week 4|In week 4, participants arrived at the site in the morning without having taken that day's dose of medication. Once the ambulatory blood pressure monitor (ABPM) had been applied, medication was taken and the participant wore the ABPM for a period of 24-hours. Systolic and diastolic blood pressure readings taken in the final 2, 4, and 6 hours of the 24-hour ABPM cycle are summarized.|Baseline, Week 4|The ambulatory blood pressure monitor (ABPM) population was defined as participants in the efficacy population that had valid baseline and Week 4 ABPM data. Valid (technically successful) ABPM had at least 23 hours of ABPM data.||mmHg||Standard Error|Least Squares Mean
798634|NCT00949884|Other Pre-specified|Change From Baseline in Mean Daytime (8am to 4pm) and Mean Nighttime (10pm to 6am) Ambulatory Blood Pressure at Week 8|In week 8, participants arrived at the site in the morning without having taken that day's dose of medication. Once the ambulatory blood pressure monitor (ABPM) had been applied, medication was taken and the participant wore the ABPM for a period of 24-hours. Daytime (8am to 4pm) and nighttime (10pm to 6am) systolic and diastolic blood pressure readings are summarized.|Baseline, Week 8|The ambulatory blood pressure monitor (ABPM) population was defined as participants in the efficacy population that had valid baseline and Week 8 ABPM data. Valid (technically successful) ABPM had at least 23 hours of ABPM data.||mmHg||Standard Error|Least Squares Mean
798635|NCT00949884|Other Pre-specified|Change From Baseline in Mean Daytime (8am to 4pm) and Mean Nighttime (10pm to 6am) Ambulatory Blood Pressure at Week 4|In week 4, participants arrived at the site in the morning without having taken that day's dose of medication. Once the ambulatory blood pressure monitor (ABPM) had been applied, medication was taken and the participant wore the ABPM for a period of 24-hours. Daytime (8am to 4pm) and nighttime (10pm to 6am) systolic and diastolic blood pressure readings are summarized.|Baseline, Week 4|The ambulatory blood pressure monitor (ABPM) population was defined as participants in the efficacy population that had valid baseline and Week 4 ABPM data. Valid (technically successful) ABPM had at least 23 hours of ABPM data.||mmHg||Standard Error|Least Squares Mean
798636|NCT00949884|Other Pre-specified|Change From Baseline in Mean 24-Hour Ambulatory Blood Pressure at Week 8|In week 8, participants arrived at the site in the morning without having taken that day's dose of medication. Once the ambulatory blood pressure monitor (ABPM) had been applied, medication was taken and the participant wore the ABPM for a period of 24-hours.|Baseline, Week 8|The ABPM population was defined as all participants in the efficacy population that had valid (technically successful required at least 23 hours of ABPM data) baseline and Week 8 ABPM data.||mmHg||Standard Error|Least Squares Mean
798637|NCT00949884|Other Pre-specified|Change From Baseline in Mean 24-Hour Ambulatory Blood Pressure at Week 4|In week 4, participants arrived at the site in the morning without having taken that day's dose of medication. Once the ambulatory blood pressure monitor (ABPM) had been applied, medication was taken and the participant wore the ABPM for a period of 24-hours.|Baseline, Week 4|The ABPM population was defined as all participants in the efficacy population that had valid (technically successful required at least 23 hours of ABPM data) baseline and Week 4 ABPM data.||mmHg||Standard Error|Least Squares Mean
798638|NCT00949884|Other Pre-specified|Percentage of Participants Achieving Blood Pressure Goals at Week 8|"Percentage of participants who achieved the following goals:
Systolic blood pressure: <140 mmHg, <135 mmHg, <130 mmHg, <120 mmHg Diastolic blood pressure: <90 mmHg, <85 mmHg, <80 mmHg Blood pressure: <140/90 mmHg, <135/80 mmHg, <130/80 mmHg, <120/80 mmHg"|Week 8|Efficacy population. Last observation carried forward. Denominator is the number of participants who have seated cuff BP measurement in each treatment group at any visit during the entire randomized treatment phase. Participants randomized to placebo-olmesartan, the measurement is after at least one dose of olmesartan.||percentage of participants analyzed|||Number
798639|NCT00949884|Other Pre-specified|Percentage of Participants Achieving Blood Pressure Goals at Week 4|"Percentage of participants who achieved the following goals:
Systolic blood pressure: <140 mmHg, <135 mmHg, <130 mmHg, <120 mmHg Diastolic blood pressure: <90 mmHg, <85 mmHg, <80 mmHg Blood pressure: <140/90 mmHg, <135/80 mmHg, <130/80 mmHg"|Week 4|Efficacy population. Last observation carried forward. Denominator is the number of participants who have seated cuff BP measurement in each treatment group at any visit during the entire randomized treatment phase. Participants randomized to placebo-olmesartan, the measurement is after at least one dose of olmesartan.||percentage of participants analyzed|||Number
798640|NCT00949884|Other Pre-specified|Incremental Change From Week 4 to Week 8 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP)|The change from Week 4 in trough SSBP at Week 8 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit.|Week 4, Week 8|The Efficacy Population included participants who received at least 1 dose of double-blind randomized study medication and had a baseline and at least 1 post-baseline blood pressure measurement. Last observation carried forward||mmHg||Standard Error|Least Squares Mean
798661|NCT00949975|Secondary|Sputum Colour - Baseline|Sputum Colour as assessed by the Bronkotest scale, reported on a scale from 1 - clear (best health status) to 5 - dark green (worst possible health status).|Baseline|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||Units on a scale||Standard Deviation|Mean
798641|NCT00949884|Other Pre-specified|Incremental Change From Week 4 to Week 8 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP)|The change from Week 4 in trough SDBP at Week 8 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit.|Week 4, Week 8|The Efficacy Population included participants who received at least 1 dose of double-blind randomized study medication and had a baseline and at least 1 post-baseline blood pressure measurement. Last observation carried forward||mmHg||Standard Error|Least Squares Mean
798642|NCT00949884|Post-Hoc|Percentage of Participants Achieving Ambulatory Blood Pressure Goal of < 135/85 mmHg at Week 8|Participants from pre-selected sites had 24-hour ambulatory blood pressure readings collected. Daytime readings were results collected between 8am and 4pm. Nighttime readings were results collected between 10pm and 6am.|Week 8|Ambulatory Blood Pressure Monitoring (ABPM) Population: All participants in the Efficacy Population that had both valid (technically successful) baseline and Week 8 ambulatory blood pressure monitor data. A technically successful ABPM had at least 23 hours of ABPM data.||percentage of population|||Number
798643|NCT00949884|Secondary|Change From Baseline to Week 4 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP)|The change from baseline in trough SDBP at Week 4 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit.|Day 0, Week 4|The Efficacy Population included participants who received at least 1 dose of double-blind randomized study medication and had a baseline and at least 1 post-baseline blood pressure measurement. Last observation carried forward||mmHg||Standard Error|Least Squares Mean
798644|NCT00949884|Secondary|Change From Baseline to Week 8 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP)|The change from baseline in trough SSBP at Week 8 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit.|Day 0, Week 8|The Efficacy Population included participants who received at least 1 dose of double-blind randomized study medication and had a baseline and at least 1 post-baseline blood pressure measurement. Last observation carried forward||mmHg||Standard Error|Least Squares Mean
798645|NCT00949884|Secondary|Change From Baseline to Week 4 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP)|The change from baseline in trough SSBP at Week 4 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit.|Day 0, Week 4|The Efficacy Population included participants who received at least 1 dose of double-blind randomized study medication and had a baseline and at least 1 post-baseline blood pressure measurement. Last observation carried forward||mmHg||Standard Error|Least Squares Mean
798646|NCT00949884|Primary|Change From Baseline to Week 8 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP)|The change from baseline in trough SDBP at Week 8 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit.|Day 0, Week 8|The Efficacy Population included participants who received at least 1 dose of double-blind randomized study medication and had a baseline and at least 1 post-baseline blood pressure measurement. Last observation carried forward.||mmHg||Standard Error|Least Squares Mean
798647|NCT00949910|Secondary|Overall Survival (OS)|OS was defined as the time from start of treatment to date of death for any reason. The median duration of OS and corresponding 95% CI were estimated by Kaplan-Meier analysis and expressed in months.|Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter|ITT/Safety Population.||months||95% Confidence Interval|Median
798648|NCT00949910|Secondary|Percentage of Participants Who Died|The percentage of participants (in nearest integer) who died from any cause was reported.|Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter|ITT/Safety Population.||percentage of participants|||Number
798649|NCT00949910|Secondary|Progression-Free Survival (PFS) According to RECIST|Tumor response was assessed by RECIST during the study. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-treatment sum LD, or the appearance of new lesions. PFS was defined as the time from start of treatment to the first event of death or PD. The median duration of PFS and corresponding 95% confidence interval (CI) were estimated by Kaplan-Meier analysis and expressed in months.|Up to approximately 4.5 years; assessed at Baseline, according to institutional standards during treatment (up to 3.5 years), and every 6 months thereafter|ITT/Safety Population; only participants with available data were included.||months||95% Confidence Interval|Median
798650|NCT00949910|Secondary|Percentage of Participants With Death or Disease Progression According to RECIST|Tumor response was assessed by RECIST during the study. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-treatment sum LD, or the appearance of new lesions. The percentage of participants (in nearest integer) who died or experienced PD was reported.|Up to approximately 4.5 years; assessed at Baseline, according to institutional standards during treatment (up to 3.5 years), and every 6 months thereafter|ITT/Safety Population; only participants with available data were included.||percentage of participants|||Number
798651|NCT00949910|Secondary|Percentage of Participants by Best Overall Response According to RECIST|Tumor response was assessed by RECIST during the study. CR was defined as disappearance of all clinical and radiographic evidence of target and non-target lesions, normal tumor markers, and absence of tumor-related symptoms. PR was defined as ≥30% decrease in sum LD of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥28 days after the initial assessment of CR or PR. SD was defined as neither sufficient shrinkage to qualify for PR but <20% increase in sum LD. Disease progression or progressive disease (PD) was defined as ≥20% increase in sum LD in reference to the smallest on-treatment sum LD, or the appearance of new lesions. The percentage of participants (in nearest integer unless the percentage is <1) with each type of best overall response was reported.|Up to approximately 4.5 years; assessed at Baseline, according to institutional standards during treatment (up to 3.5 years), and every 6 months thereafter|ITT/Safety Population.||percentage of participants|||Number
798652|NCT00949910|Secondary|Percentage of Participants With Disease Control According to RECIST|Disease control was defined as a best overall response of either CR, PR, or stable disease (SD) as assessed by RECIST during the study. CR was defined as disappearance of all clinical and radiographic evidence of target and non-target lesions, normal tumor markers, and absence of tumor-related symptoms. PR was defined as ≥30% decrease in sum LD of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥28 days after the initial assessment of CR or PR. SD was defined as neither sufficient shrinkage to qualify for PR but less than (<) 20% increase in sum LD. The percentage of participants (in nearest integer) with disease control was reported.|Up to approximately 4.5 years; assessed at Baseline, according to institutional standards during treatment (up to 3.5 years), and every 6 months thereafter|ITT/Safety Population.||percentage of participants|||Number
798653|NCT00949910|Primary|Percentage of Participants With Objective Response According to Response Evaluation Criteria in Solid Tumors (RECIST)|Objective response was defined as a best overall response of either complete response (CR) or partial response (PR) as assessed by RECIST during the study. CR was defined as disappearance of all clinical and radiographic evidence of target and non-target lesions, normal tumor markers, and absence of tumor-related symptoms. PR was defined as greater than or equal to (≥) 30 percent (%) decrease in sum of longest diameter (LD) of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥28 days after the initial assessment of CR or PR. The percentage of participants (in nearest integer) with objective response was reported.|Up to approximately 4.5 years; assessed at Baseline, according to institutional standards during treatment (up to 3.5 years), and every 6 months thereafter|ITT/Safety Population.||percentage of participants|||Number
798654|NCT00949975|Secondary|Exacerbations - Clinic Defined|Number of patients having a clinic defined disease exacerbation|Duration of the the treatment period - 12 weeks|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||Participants|||Number
798655|NCT00949975|Secondary|St George's Respiratory Questionnaire (COPD) - End-value Overall Score|St George’s Respiratory Questionnaire for Chronic Obstructive Pulmonary Disease, as a measure of Quality of Life (reported on a % scale from 0 (best health status) to 100(worst possible status)).questionaire assessed on vist 6 -( last on treatment clinic visit)|Measured Day 1 and 12 weeks|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||Scores on a scale||Standard Error|Least Squares Mean
798656|NCT00949975|Secondary|St George's Respiratory Questionnaire (COPD) - Overall Score at Baseline|St George’s Respiratory Questionnaire for Chronic Obstructive Pulmonary Disease, as a measure of Quality of Life (reported on a % scale from 0 (best health status) to 100(worst possible status)).|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||Scores on a scale||Standard Deviation|Mean
798657|NCT00949975|Secondary|Six-minute Walk Test - End-value Distance Walked (m)|distance walked on vist 6 - last on treatment clinic visit|Measured Day 1 and 12 weeks|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||m||Standard Error|Least Squares Mean
798658|NCT00949975|Secondary|Six-minute Walk Test - Distance Walked at Baseline (m)||Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||m||Standard Deviation|Mean
798659|NCT00949975|Secondary|Use of Reliever Medication|Daily average of number of inhalations of reliever medication|Last 6 weeks on treatment|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||Inhalations||Standard Error|Least Squares Mean
798660|NCT00949975|Secondary|Sputum Colour - End Value|Sputum Colour as assessed by the Bronkotest scale, reported on a scale from 1 - clear (best health status) to 5 - dark green (worst possible health status).End of treatment week 12|Measured at clinic visits:1, 4, 8 and 12 weeks|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||Units on a scale||Standard Error|Least Squares Mean
799137|NCT00952211|Primary|Profile of Mood States (POMS) - Fatigue Subscale|POMS fatigue subscale: 7 items; range 0-28; higher score indicates worse symptoms, i.e., more fatigue|10 days after beginning CPAP treatment|Data only available for 2 subjects; one subject did not provide data for this questionnaire.||units on a scale||Standard Deviation|Mean
798662|NCT00949975|Secondary|BCSS - End-value Total Score|Breathlessness, Cough and Sputum Scale, patient reported questionnaire as a measure of respiratory symptoms (reported on a 0(best health status) to 12(worst possible status)scale). Last 6 weeks on treatment|Measured daily in the evening for 12 weeks|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||Units on a scale||Standard Error|Least Squares Mean
798663|NCT00949975|Secondary|BCSS - Baseline Total Score|Breathlessness, Cough and Sputum Scale, patient reported questionnaire as a measure of respiratory symptoms (reported on a 0 (best health status) to 12 (worst possible status)scale).Baseline is the mean of last 10 days of data before start of treatment|Baseline|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||Units on a scale||Standard Deviation|Mean
798664|NCT00949975|Secondary|EXACT - End-value Total Score|EXAcerbations of Chronic pulmonary disease Tool, patient questionnaire as a measure of respiratory symptoms (reported as units on a 0 (best health status) to 100 (worst possible status)scale). Last 6 weeks on treatment.|Measured daily in the evening for 12 weeks|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||Units on a scale||Standard Error|Least Squares Mean
798665|NCT00949975|Secondary|EXACT - Baseline Total Score|EXAcerbations of Chronic pulmonary disease Tool, patient questionnaire as a measure of respiratory symptoms (reported as units on a 0 (best health status) to 100 (worst possible status)scale). Baseline is the mean of last 10 days of data before start of treatment.|Baseline|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||Units on a scale||Standard Deviation|Mean
798666|NCT00949975|Secondary|FEV1 - End-value Measured by Patient at Home (L) in the Morning|Forced Expiratory Volume in 1 second (L)|Last 6 weeks on treatment|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Error|Least Squares Mean
798667|NCT00949975|Secondary|FEV1 - Baseline Measured by Patient at Home (L) in the Morning|Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured at home by the patient each morning.Baseline is the mean of last 10 days of data before start of treatment|Baseline|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Deviation|Mean
798668|NCT00949975|Secondary|PEF - End-value Measured by Patient at Home (L/Min) in the Morning|Peak Expiratory Flow (L/min)|Last 6 weeks on treatment|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L/min||Standard Error|Least Squares Mean
798669|NCT00949975|Secondary|PEF - Baseline Measured by Patient at Home (L/Min) in the Morning|Peak Expiratory Flow (L/min) as a measure of lung function, measured at home by the patient each morning.Baseline is the mean of last 10 days of data before start of treatment|Baseline|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L/min||Standard Deviation|Mean
798670|NCT00949975|Secondary|Post-bronchodilator IC (L) - End-value|End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)|Measured at clinic visits: 1, 4, 8 and 12 weeks|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Error|Least Squares Mean
798671|NCT00949975|Secondary|Post-bronchodilator IC (L) - Baseline|Inspiratory Capacity (L) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Deviation|Mean
798672|NCT00949975|Secondary|Pre-bronchodilator IC (L) - End-value|End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)|Measured at clinic visits: 1, 4, 8 and 12 weeks|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Error|Least Squares Mean
798673|NCT00949975|Secondary|Pre-bronchodilator IC (L) - Baseline|Inspiratory Capacity (L) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Deviation|Mean
798674|NCT00949975|Secondary|Post-bronchodilator FVC (L) - End-value|End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)|Measured at clinic visits: 1, 4, 8 and 12 weeks|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Error|Least Squares Mean
798675|NCT00949975|Secondary|Post-bronchodilator FVC (L) - Baseline|Forced Vital Capacity (L) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Deviation|Mean
798676|NCT00949975|Secondary|Pre-bronchodilator FVC (L) - End-value|End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)|Measured at clinic visits: 1, 4, 8 and 12 weeks|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Error|Least Squares Mean
798677|NCT00949975|Secondary|Pre-bronchodilator FVC (L) - Baseline|Forced Vital Capacity (L) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Deviation|Mean
798678|NCT00949975|Secondary|Post-bronchodilator FEV1 (L) - End-value|End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)|Measured at clinic visits: 1, 4, 8 and 12 weeks|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Error|Least Squares Mean
798679|NCT00949975|Secondary|Post-bronchodilator FEV1 (L) - Baseline|Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Deviation|Mean
798680|NCT00949975|Primary|End-value Pre-bronchodilator FEV1 (L)|End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)|Measured at clinic visits: 1, 4, 8 and 12 weeks|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Error|Least Squares Mean
798681|NCT00949975|Primary|Baseline Pre-bronchodilator FEV1 (L)|Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Deviation|Mean
798682|NCT00950183|Secondary|Postoperative Complications||postop day 1 up to postop day 14|Data not analyzed due to study termination|||||
798683|NCT00950183|Secondary|Surgical Complications||Day of Surgery|Data not analyzed due to study termination|||||
798684|NCT00950183|Secondary|Patient Satisfaction||first postoperative visit (between postop day 10 and 14)|Data not analyzed due to study termination|||||
798685|NCT00950183|Secondary|Narcotic Pain Medication Usage||postop day 1 up to postop day 14|Data not analyzed due to study termination.|||||
798686|NCT00950183|Primary|Visual Analog Scale (VAS) Pain Scores||postop day 1 up to postop day 14|Data not analyzed due to study termination|||||
798687|NCT00950235|Secondary|Large for Gestational Age (LGA)|Large-for-gestational-age defined as weight greater than the 90th percentile for gestational age at birth.|At birth|Babies born to participants||participants|||Number
798688|NCT00950235|Secondary|Pregnancy Weight Change||baseline to 34 weeks gestation|Participants returning for follow up visit or validated clinical data||kg||Standard Deviation|Mean
798689|NCT00950235|Primary|Maternal Weight Change|We chose the weight at 2 weeks postpartum, rather than at an end point during pregnancy, to avoid the contribution of products of conception, maternal edema, and increased maternal blood volume to the weight gain.|baseline to 2 weeks post partum|Data was from follow up visit or validated clinical data||kg||Standard Deviation|Mean
798712|NCT00950352|Secondary|Testing if Improvements in Cognitive Function as Well as Brain Chemical and Structural Parameters Will be Associated With Greater Reductions in Drug Use.|Self report drug use and mood will be evaluated at each study visit throughout the course of the study. Also, urine samples will be collected twice a week for drugs of abuse testing.|Throughout the course of the study||||||
798713|NCT00950352|Secondary|Testing if Neuroimaging Measures Will Show Significant Improvements in Brain Chemical and Structural Parameters After 8-9 Weeks of Citicoline Treatment in Methamphetamine Dependent Subjects.|Phosphorus-31 ((31)P) magnetic resonance spectroscopy (MRS) was used to evaluate changes in mitochondrial high energy phosphates, including phosphocreatine (PCr) and β-nucleoside triphosphate (β-NTP, primarily ATP in brain) levels.|Neuroimaging will occur at week 0 and week 8/9||||||
798714|NCT00950352|Secondary|Testing if Citicoline Administration Will be Associated With Significant Improvements in Neuropsychological Performance.|Cognitive measurement tests will be employed.|Neuropsychological testing will occur at week 0 and week 8/9||||||
798715|NCT00950352|Primary|Methamphetamine Dependent Subjects Treated With Citicoline vs Placebo|Total Amount of Methamphetamine consumed by the participants after 8-9 weeks of treatment. Methamphetamine was assessed twice weekly.|8 weeks, assessed twice weekly starting week1|||total amount consumed in grams||Standard Deviation|Mean
798798|NCT00950599|Primary|Change From Baseline in A1C at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in A1C achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||percentage of glycosylated hemoglobins||Standard Error|Mean
798716|NCT00950599|Secondary|Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0 & 100 mg Cohort|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|From Week 6 to Week 10 for AEs; up to 30 days post follow-up in both cohorts for SAEs and Discontinuations|All participants treated during the follow-up period.||Percentage of participants|||Number
798717|NCT00950599|Secondary|Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0-40 mg Cohort|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|From Week 12 to Week 16 for AEs; up to 30 days post follow-up in both cohorts for SAEs and Discontinuations|All participants treated during the follow-up period.||Percentage of participants|||Number
798718|NCT00950599|Secondary|Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0 & 100 mg Cohort|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|up to Week 6 for AEs; up to 30 days post-double-blind period but prior to follow-up period if any for SAEs and up to 30 days post-double-blind period for Discontinuations|All participants randomized and treated during the double-blind period.||Percentage of participants|||Number
798719|NCT00950599|Secondary|Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0-40 mg Cohort|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|up to Week 12 for AEs; up to 30 days post-double-blind period but prior to follow-up period if any for SAEs and up to 30 days post-double-blind period for Discontinuations|All participants randomized and treated during the double-blind period.||Percentage of participants|||Number
798720|NCT00950599|Secondary|Discontinuations During the Double-Blind Phase Due to Lack of Glycemic Control|Number of participants discontinuing from the double-blind phase due to lack of glycemic control at Week 4 and Week 6. (Note: this analysis was not performed.)|Week 4, Week 6||||||
798721|NCT00950599|Secondary|Change From Baseline in 60-minute Postprandial Glucagon Excursion at Week 6 in the 0 & 100 mg Cohort|Adjusted mean change from baseline in postprandial glucagon excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 6 in the 0 & 100 mg cohort. (Note: this analysis was not performed.)|Baseline, Week 6||||||
798722|NCT00950599|Secondary|Change From Baseline in 60-minute Postprandial FFA Excursion at Week 6 in the 0 & 100 mg Cohort|Adjusted mean change from baseline in postprandial FFA excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 6 in the 0 & 100 mg cohort. (Note: this analysis was not performed.)|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||||
798723|NCT00950599|Secondary|Percentage of Participants Achieving A1C < 7% at Week 6 in the 0 & 100 mg Cohort|Percentage of participants achieving A1C < 7%, the American Diabetic Association's defined goal for glycemia, at each dose of saxagliptin at Week 6 in the 0 & 100 mg cohort.|Week 6|Randomized participants. To be included in the Week 6 LOCF analysis, subjects must have had at least 1 post-baseline measurement.||Percentage of Participants|||Number
798724|NCT00950599|Secondary|Change From Baseline in 60 Minute Postprandial Glucose at Week 6 by Baseline Category in the 0 & 100 mg Cohort|Adjusted mean change from baseline in 60-minute postprandial glucose achieved at each dose of saxagliptin at Week 6 in subjects with baseline 60-minute postprandial glucose <140 mg/dL, ≥140 to <200 mg/dL, and ≥200 mg/dL in the 0 & 100 mg cohort.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6, participants must have had a baseline and at least 1 post-baseline measurement.||mg/dL||Standard Deviation|Mean
798725|NCT00950599|Secondary|Change From Baseline in FSG at Week 6 in Subjects by Baseline FSG Category in the 0 & 100 mg Cohort.|Adjusted mean change from baseline in FSG achieved at each dose of saxagliptin at Week 6 in subjects with baseline FSG <140 mg/dL, ≥140 mg/dL to <180 mg/dL, and ≥ 180 mg/dL in the 0 & 100 mg cohort.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||mg/dL||Standard Deviation|Mean
798726|NCT00950599|Secondary|Change From Baseline in A1C at Week 6 by Baseline A1C Category in the 0 & 100 Cohort|Adjusted mean change from baseline in A1C achieved at each dose of saxagliptin at Week 6 in subjects with baseline A1C <7%, ≥7% to <8%, ≥8% to <9%, and ≥9% in the 0 & 100 mg cohort.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||percent||Standard Deviation|Mean
798727|NCT00950599|Secondary|Change From Baseline in Fructosamine at 4 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts|Mean change from baseline in fructosamine achieved at each dose of saxagliptin during the Follow-up period at Week 16 in the 0-40 mg cohort and at Week 10 in the 0 & 100 mg cohort.|Baseline, Week 10, Week 16|Randomized participants. To be included in analysis of change from baseline to Week 16 (0-40 mg cohort) and Week 10 (0&100 mg cohort), participants must have had a baseline and at least 1 follow-up period measurement. Week 16 and Week 10 assessments are the assessments closest to the respective target date (or later assessment in the case of a tie)||umol/L||Standard Deviation|Mean
798728|NCT00950599|Secondary|Change From Baseline in Fructosamine at 2 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts|Mean change from baseline in fructosamine achieved at each dose of saxagliptin during the Follow-up period at Week 14 in the 0-40 mg cohort and at Week 8 in the 0 & 100 mg cohort.|Baseline, Week 8, Week 14|Randomized participants. To be included in analysis of change from baseline to Week 14 or Week 8, participants must have had a baseline and at least 1 post-baseline measurement. The Week 14 and Week 8 assessments are the assessments closest to the respective target dates (or later assessments in the case of a tie).||umol/L||Standard Deviation|Mean
798729|NCT00950599|Secondary|Change From Baseline in FSG at 4 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts|Mean change from baseline in FSG achieved at each dose of saxagliptin during the follow-up period at Week 16 in the 0-40 mg cohort and at Week 10 in the 0 & 100 mg cohort.|Baseline, Week 10, Week 16|Randomized participants. To be included in analysis of change from baseline to Week 16 (0-40 mg cohort) and Week 10 (0&100 mg cohort), participants must have had a baseline and at least 1 follow-up period measurement. Week 16 and Week 10 assessments are the assessments closest to the respective target date (or later assessment in the case of a tie)||mg/dL||Standard Deviation|Mean
798730|NCT00950599|Secondary|Change From Baseline in FSG at 2 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts|Mean change from baseline in FSG achieved at each dose of saxagliptin during Follow-Up period at Week 14 in the 0-40 mg cohort and at Week 8 in the 0 & 100 mg cohort.|Baseline, Week 8, Week 14|Randomized participants. To be included in analysis of change from baseline to Week 14 (0-40 mg cohort) or Week 8 (0&100 mg cohort), participants must have had a baseline and at least 1 follow-up period measurement. Week 14 and Week 8 assessments are the assessments closest to the respective target dates (or later assessments in the case of a tie).||mg/dL||Standard Deviation|Mean
798731|NCT00950599|Secondary|Change From Baseline in A1C at 4 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts|Mean change from baseline in A1C achieved at each dose of saxagliptin during the Follow-Up period at Week 16 in the 0-40 mg cohort and at Week 10 in the 0 & 100 mg cohort.|Baseline, Week 10, Week 16|Randomized participants. To be included in analysis of change from baseline to Week 16 (0-40 mg cohort) and Week 10 (0&100 mg cohort), participants must have had a baseline and at least 1 follow-up period measurement. Week 16 and Week 10 assessments are the assessments closest to the respective target date (or later assessment in the case of a tie)||percentage of glycated hemoglobins||Standard Deviation|Mean
798732|NCT00950599|Secondary|Change From Baseline in A1C at 2 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts|Mean change from baseline in A1C achieved at each dose of saxagliptin during the Follow-Up period at Week 14 in the 0-40 mg cohort and at Week 8 in the 0 & 100 mg cohort.|Baseline, Week 14|Randomized participants. To be included in analysis of change from baseline to Week 14 (0-40 mg cohort) or Week 8 (0&100 mg cohort), participants must have had a baseline and at least 1 follow-up period measurement. Week 14 and Week 8 assessments are the assessments closest to the respective target dates (or later assessments in the case of a tie).||percentage of glycated hemoglobins||Standard Deviation|Mean
798733|NCT00950599|Secondary|Change From Baseline in Matsuda Index at Week 12 in the 0-40 mg Cohort|Mean change from baseline in Matsuda index achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort. The Matsuda index is a scale designed to give numbers between 0 and 12, with a linear relationship to other indices of insulin sensitivity. The higher the number, the better the insulin sensitivity (improvement).|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||units on a scale||Standard Deviation|Mean
798734|NCT00950599|Secondary|Change From Baseline in Matsuda Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Mean change from baseline in Matsuda index achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. The Matsuda index is a scale designed to give numbers between 0 and 12, with a linear relationship to other indices of insulin sensitivity. The higher the number, the better the insulin sensitivity (improvement).|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||units on a scale||Standard Deviation|Mean
798735|NCT00950599|Secondary|Change From Baseline in 30-minute Insulinogenic Index at Week 12 in the 0-40 mg Cohort|Mean change from baseline in 30-minute insulinogenic index of a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort. The insulinogenic index is a unitless scale which is a measure of insulin production normalized for the glucose stimulus. Higher numbers mean more beta cell function (improvement). The low value is zero. The highest value obtainable is unknown.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||units on a scale||Standard Deviation|Mean
798736|NCT00950599|Secondary|Change From Baseline in 30-minute Insulinogenic Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts.|Mean change from baseline in 30-minute insulinogenic index of a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. The insulinogenic index is a unitless scale which is a measure of insulin production normalized for the glucose stimulus. Higher numbers mean more beta cell function (improvement). The low value is zero. The highest value obtainable is unknown.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||units on a scale||Standard Deviation|Mean
799448|NCT00947531|Secondary|Change From Baseline in Trail-making Test|The Trail-making test is a frequently used instrument for the assessment of executive function.|week 4, 12, 16, 24||||||
798737|NCT00950599|Secondary|Change From Baseline in 15-minute Insulinogenic Index at Week 12 in the 0-40 mg Cohort|Mean change from baseline in 15-minute insulinogenic index of a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort. The insulinogenic index is a unitless scale which is a measure of insulin production normalized for the glucose stimulus. Higher numbers mean more beta cell function (improvement). The low value is zero. The highest value obtainable is unknown.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||units on a scale||Standard Deviation|Mean
798738|NCT00950599|Secondary|Change From Baseline in 15-minute Insulinogenic Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Mean change from baseline in 15-minute insulinogenic index of a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. The insulinogenic index is a unitless scale which is a measure of insulin production normalized for the glucose stimulus. Higher numbers mean more beta cell function (improvement). The low value is zero. The highest value obtainable is unknown.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||units on a scale||Standard Deviation|Mean
798739|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial FFA Excursion at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) FFA excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||mEq/mL||Standard Error|Mean
798740|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial FFA Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) FFA excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||mEq/mL||Standard Error|Mean
798741|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial Glucagon Excursion at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) glucagon excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||pg/mL||Standard Error|Mean
798742|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial Glucagon Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) glucagon excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||pg/mL||Standard Error|Mean
798743|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial FFA at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) FFA 30 minutes after a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||mEg/L||Standard Error|Mean
798744|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial Free Fatty Acids (FFA) at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) FFA 30 minutes after a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||mEg/L||Standard Error|Mean
798745|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial Glucagon at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) glucagon 30 minutes after a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||pg/mL||Standard Error|Mean
798746|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial Glucagon at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) glucagon 30 minutes after a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||pg/mL||Standard Error|Mean
798747|NCT00950599|Secondary|Change From Baseline in 60-minute Postprandial C-peptide Excursion at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||ng/mL||Standard Error|Mean
798748|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial C-peptide Excursion at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||ng/mL||Standard Error|Mean
799858|NCT00959049|Secondary|Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)||7 days after each vaccination|Safety population; Afluria Cohort A receiving 2 doses N=96, Fluzone Cohort A receiving 2 doses N=110||Participants|||Number
798749|NCT00950599|Secondary|Change From Baseline in 15-minute Postprandial C-peptide Excursion at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||ng/mL||Standard Error|Mean
798750|NCT00950599|Secondary|Change From Baseline in 60-minute Postprandial C-peptide Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||ng/mL||Standard Error|Mean
798751|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial C-peptide Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||ng/mL||Standard Error|Mean
798752|NCT00950599|Secondary|Change From Baseline in 15-minute Postprandial C-peptide Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||ng/mL||Standard Error|Mean
798753|NCT00950599|Secondary|Change From Baseline in 60-minute Postprandial Insulin Excursion at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||uU/mL||Standard Error|Mean
798754|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial Insulin Excursion at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||uU/mL||Standard Error|Mean
798755|NCT00950599|Secondary|Change From Baseline in 15-minute Postprandial Insulin Excursion at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||uU/mL||Standard Error|Mean
798756|NCT00950599|Secondary|Change From Baseline in 60-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||uU/mL||Standard Error|Mean
798757|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||uU/mL||Standard Error|Mean
798758|NCT00950599|Secondary|Change From Baseline in 15-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||uU/mL||Standard Error|Mean
798759|NCT00950599|Secondary|Change From Baseline in 60-minute Postprandial Glucose Excursion at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||mg/dL||Standard Error|Mean
798760|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial Glucose Excursion at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||mg/dL||Standard Error|Mean
798841|NCT00950664|Other Pre-specified|Reduction of Tsui Score at Each Visit From Baseline|Tsui scale (range: 0-25, higher values represent worse cervical dystonia.) Negative numbers to represent decreases of Tsui scale.|8, 12 and 16 weeks after injection|||units on a scale||Standard Deviation|Mean
798761|NCT00950599|Secondary|Change From Baseline in 15-minute Postprandial Glucose Excursion at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||mg/dL||Standard Error|Mean
798762|NCT00950599|Secondary|Change From Baseline in 60-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||mg/dL||Standard Error|Mean
798763|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||mg/dL||Standard Error|Mean
798764|NCT00950599|Secondary|Change From Baseline in 15-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||mg/dL||Standard Error|Mean
798765|NCT00950599|Secondary|Change From Baseline in 60-minute Postprandial C-peptide at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||ng/mL||Standard Error|Mean
798766|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial C-peptide at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||ng/mL||Standard Error|Mean
798767|NCT00950599|Secondary|Change From Baseline in 15-minute Postprandial C-peptide at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||ng/mL||Standard Error|Mean
798768|NCT00950599|Secondary|Change From Baseline in 60-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||ng/mL||Standard Error|Mean
798769|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||ng/mL||Standard Error|Mean
798770|NCT00950599|Secondary|Change From Baseline in 15-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||ng/mL||Standard Error|Mean
798771|NCT00950599|Secondary|Change From Baseline in 60-minute Postprandial Insulin at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) insulin 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||uU/mL||Standard Error|Mean
798772|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial Insulin at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) insulin 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||uU/mL||Standard Error|Mean
798773|NCT00950599|Secondary|Change From Baseline in 15-minute Postprandial Insulin at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) insulin 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||uU/mL||Standard Error|Mean
798774|NCT00950599|Secondary|Change From Baseline in 60-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) insulin 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||uU/mL||Standard Error|Mean
798775|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) insulin 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||uU/mL||Standard Error|Mean
798776|NCT00950599|Secondary|Change From Baseline in 15-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial insulin 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||uU/mL||Standard Error|Mean
798777|NCT00950599|Secondary|Change From Baseline in 60-minute Postprandial Glucose at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) glucose 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||mg/dL||Standard Error|Mean
798778|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial Glucose at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial glucose 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||mg/dL||Standard Error|Mean
798779|NCT00950599|Secondary|Change From Baseline in 15-minute Postprandial Glucose at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) glucose 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||mg/dL||Standard Error|Mean
798780|NCT00950599|Secondary|Change From Baseline in 60-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) glucose 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||mg/dL||Standard Error|Mean
798781|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial glucose 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||mg/dL||Standard Error|Mean
798782|NCT00950599|Secondary|Change From Baseline in 15-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) glucose 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||mg/dL||Standard Error|Mean
798783|NCT00950599|Secondary|Change From Baseline in Postprandial C-peptide 0-60 Minute AUC at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (postprandial) C-peptide 0-60 minute AUC response to a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort. Area Under the Curve (AUC) is defined as the area under the plot of plasma concentration of drug (not logarithm of the concentration) against time after drug administration. The AUC is of particular use in estimating bioavailability of drugs, and in estimating total clearance of drugs.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||ng*min/mL||Standard Error|Mean
798784|NCT00950599|Secondary|Change From Baseline in Postprandial C-peptide 0-60 Minute AUC at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 0-60 minute AUC response to a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. Area Under the Curve (AUC) is defined as the area under the plot of plasma concentration of drug (not logarithm of the concentration) against time after drug administration. The AUC is of particular use in estimating bioavailability of drugs, and in estimating total clearance of drugs.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||ng*min/mL||Standard Error|Mean
798797|NCT00950599|Secondary|Change From Baseline in A1C at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in A1C achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||percentage of glycosylated hemoglobins||Standard Error|Mean
799872|NCT00951171|Primary|Clinical Pregnancy|positive beta HCG test|1 month|All study women undergoing IUI were included||positive pregnancy test (beta HCG)|||Number
798785|NCT00950599|Secondary|Change From Baseline in Postprandial Insulin 0-60 Minute AUC at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) insulin 0-60 minute AUC response to a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort. Area Under the Curve (AUC) is defined as the area under the plot of plasma concentration of drug (not logarithm of the concentration) against time after drug administration. The AUC is of particular use in estimating bioavailability of drugs, and in estimating total clearance of drugs.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||uU*min/mL||Standard Error|Mean
798786|NCT00950599|Secondary|Change From Baseline in Postprandial Insulin 0-60 Minute AUC at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) insulin 0-60 minute AUC response to a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. Area Under the Curve (AUC) is defined as the area under the plot of plasma concentration of drug (not logarithm of the concentration) against time after drug administration. The AUC is of particular use in estimating bioavailability of drugs, and in estimating total clearance of drugs.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||uU*min/mL||Standard Error|Mean
798787|NCT00950599|Secondary|Change From Baseline in Postprandial Glucose 0-60 Minute AUC at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) glucose 0-60 minute AUC response to a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort. Area Under the Curve (AUC) is defined as the area under the plot of plasma concentration of drug (not logarithm of the concentration) against time after drug administration. The AUC is of particular use in estimating bioavailability of drugs, and in estimating total clearance of drugs.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||mg*min/dL||Standard Error|Mean
798788|NCT00950599|Secondary|Change From Baseline in Postprandial Glucose 0-60 Minute Area Under the Curve (AUC) at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) glucose 0-60 minute AUC response to a liquid meal tolerance test (MTT) achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. Area Under the Curve (AUC) here is defined as the area under the plot of the serum concentration of glucose against time after ingesting the meal for the first 60 minutes after the subject drinks the liquid meal.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||mg*min/dL||Standard Error|Mean
798789|NCT00950599|Secondary|Change From Baseline in C-peptide at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in C-peptide achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||ng/mL||Standard Error|Mean
798790|NCT00950599|Secondary|Change From Baseline in C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in C-peptide achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||ng/mL||Standard Error|Mean
798791|NCT00950599|Secondary|Change From Baseline in Insulin at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in insulin achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||uU/mL||Standard Error|Mean
798792|NCT00950599|Secondary|Change From Baseline in Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in fasting insulin achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||uU/mL||Standard Error|Mean
798793|NCT00950599|Secondary|Change From Baseline in Fructosamine at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in fructosamine achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||umol/L||Standard Error|Mean
798794|NCT00950599|Secondary|Change From Baseline in Fructosamine at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in fructosamine achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||umol/L||Standard Error|Mean
798795|NCT00950599|Secondary|Change From Baseline in FSG at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in FSG achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||mg/dL||Standard Error|Mean
798796|NCT00950599|Secondary|Change From Baseline in Fasting Serum Glucose (FSG) at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in FSG achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||mg/dL||Standard Error|Mean
812452|NCT01070784|Primary|Vital Signs- Sitting Diastolic Blood Pressure(DBP)|Change from baseline|Baseline and 52 week after|||mmHg||Standard Deviation|Mean
798799|NCT00950599|Primary|Analysis of Test for Positive Efficacy Trend in Change From Baseline in Hemoglobin A1c (A1C) at Week 12 in the 0-40 mg Cohort|Positive efficacy trend among doses of saxagliptin by assessing the adjusted mean change from baseline in A1C in the 0-40 mg cohort. The unit of measurement for A1C is percent.|Baseline, Week 12|Randomized participants. To be included in analysis of positive efficacy trend in change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||percentage of glycosylated hemoglobins||Standard Deviation|Mean
798800|NCT00950612|Secondary|Anti-M72 Specific Antibody Concentrations|Antibody concentrations given in Enzyme-Linked Immunosorbent Assay (ELISA) units per millilitre (EL.U/mL) were expressed as Geometric Mean Concentrations (GMCs).|At Day 0, 30, 60 and 210|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received at least one dose of study vaccine/placebo according to their random assignment, for whom data concerning immunogenicity outcome measures were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
798801|NCT00950612|Secondary|Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines|Among cytokines expressed were interleukin-2 [IL-2], interferon-gamma [IFN-γ], tumour necrosis factor-alpha [TNF-α] and cluster of differentiation 40-ligand [CD40-L], after background reduction stimulated by M72. Analysis of cytokines expression was done by means of in vitro flow cytometry, using intracellular cytokine staining (ICS).|At Day 0, 7, 30, 37, 60 and 210|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received at least one dose of study vaccine/placebo according to their random assignment, for whom data concerning immunogenicity outcome measures were available.||T cells/million cells||Inter-Quartile Range|Median
798802|NCT00950612|Secondary|Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines|Among cytokines expressed were interleukin-2 [IL-2], interferon-gamma [IFN-γ], tumour necrosis factor-alpha [TNF-α] and cluster of differentiation 40-ligand [CD40-L], after background reduction stimulated by M72. Analysis of cytokines expression was done by means of in vitro flow cytometry, using intracellular cytokine staining (ICS).|At Day 0, 7, 30, 37, 60 and 210|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received at least one dose of study vaccine/placebo according to their random assignment, for whom data concerning immunogenicity outcome measures were available.||T cells/million cells||Inter-Quartile Range|Median
798803|NCT00950612|Secondary|Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines|Among cytokines expressed were interleukin-2 [IL-2], interferon-gamma [IFN-γ], tumour necrosis factor-alpha [TNF-α] and cluster of differentiation 40-ligand [CD40-L], after background reduction stimulated by M72. Analysis of cytokines expression was done by means of in vitro flow cytometry, using intracellular cytokine staining (ICS).|At Day 0, 7, 30, 37, 60 and 210|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received at least one dose of study vaccine/placebo according to their random assignment, for whom data concerning immunogenicity outcome measures were available.||T cells/million cells||Inter-Quartile Range|Median
798804|NCT00950612|Secondary|Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines|Among cytokines expressed were interleukin-2 [IL-2], interferon-gamma [IFN-γ], tumour necrosis factor-alpha [TNF-α] and cluster of differentiation 40-ligand [CD40-L], after background reduction stimulated by M72. Analysis of cytokines expression was done by means of in vitro flow cytometry, using intracellular cytokine staining (ICS).|At Day 0, 7, 30, 37, 60 and 210|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received at least one dose of study vaccine/placebo according to their random assignment, for whom data concerning immunogenicity outcome measures were available.||T cells/million cells||Inter-Quartile Range|Median
798805|NCT00950612|Secondary|Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines|Among cytokines expressed were interleukin-2 [IL-2], interferon-gamma [IFN-γ], tumour necrosis factor-alpha [TNF-α] and cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry, using intracellular cytokine staining (ICS).|At Day 0, 7, 30, 37, 60 and 210|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received at least one dose of study vaccine/placebo according to their random assignment, for whom data concerning immunogenicity outcome measures were available.||T cells/million cells||Inter-Quartile Range|Median
798806|NCT00950612|Primary|Number of Subjects With Haematological Levels Below Normal|"Among haematological parameters assessed were platelets [PLA], red blood cells [RBC] and white blood cells [WBC].
Levels of haematological parameters assessed in terms of normal laboratory values were – normal, below and above."|At Day 0, 7, 30, 37 and 60|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Subjects|||Number
798807|NCT00950612|Primary|Number of Subjects With Biochemical and Haematological Below Normal Levels|Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CREA], haemoglobin [Hgb]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were – normal, below and above.|At Day 0, 7, 30, 37 and 60|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Subjects|||Number
798808|NCT00950612|Primary|Number of Subjects With Haematological Levels Above Normal|"Among haematological parameters assessed were platelets [PLA], red blood cells [RBC] and white blood cells [WBC].
Levels of haematological parameters assessed in terms of normal laboratory values were – normal, below and above."|At Day 0, 7, 30, 37 and 60|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Subjects|||Number
798809|NCT00950612|Primary|Number of Subjects With Biochemical and Haematological Above Normal Levels|Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CREA], haemoglobin [Hgb]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were – normal, below and above.|At Day 0, 7, 30, 37 and 60|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Subjects|||Number
799936|NCT00961350|Secondary|The Number of Participants With Gastric and/or Duodenal Ulcers|The Number of Participants with Gastric and/or Duodenal Ulcers throughout 6 months of treatment.|6 Months|Intent to Treat (ITT) Population||participants|||Number
798810|NCT00950612|Primary|Number of Subjects With Normal Haematological Levels|"Among haematological parameters assessed were platelets [PLA], red blood cells [RBC] and white blood cells [WBC].
Levels of haematological parameters assessed in terms of normal laboratory values were – normal, below and above."|At Day 0, 7, 30, 37 and 60|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Subjects|||Number
798811|NCT00950612|Primary|Number of Subjects With Normal Biochemical and Haematological Levels|Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CREA], haemoglobin [Hgb]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were – normal, below and above.|At Day 0, 7, 30, 37 and 60|The analysis was performedon the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Subjects|||Number
798812|NCT00950612|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Day 0 up to Day 210)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Subjects|||Number
798813|NCT00950612|Primary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset out-side the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 30-day (Days 0-29) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Subjects|||Number
798814|NCT00950612|Primary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms were fatigue, temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastrointestinal symptoms (gastro) [nausea, vomiting, diarrhoea and/or abdominal pain], headache, malaise and myalgia. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Subjects|||Number
798815|NCT00950612|Primary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. Relationship analysis was not performed.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Subjects|||Number
798816|NCT00950651|Secondary|Patient Diary: Difficulty With Stairs (Between Visit Means) at Week 12|As part of the daily diary for the entire study, patients rated their difficulty with stairs with their worst knee using a five-point scale ranging from 1=No problem to 5=Severe difficulty. Mean scores summarizing the entries of the preceding period were calculated.|12 weeks|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.||Units on a scale||Standard Deviation|Mean
798817|NCT00950651|Secondary|Patient Diary: Difficulty With Walking (Between Visit Means) at Week 12|As part of the daily diary for the entire study, patients rated their difficulty walking with their worst knee using a five-point scale ranging from 1=No problem to 5=Severe difficulty. Mean scores summarizing the entries of the preceding period were calculated.|12 weeks|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.||Units on a scale||Standard Deviation|Mean
798818|NCT00950651|Secondary|Patient Diary: Ability Getting Things Done (Between Visit Means) at Week 12|As part of the daily diary for the entire study, patients rated their ability to get things done with their worst knee using a five-point scale ranging from: 1=No problem to 5=A lot of things didn’t get done. Mean scores summarizing the entries of the preceding period were calculated.|12 weeks|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.||Units on a scale||Standard Deviation|Mean
798819|NCT00950651|Secondary|Patient Diary: Stiffness (Between Visit Means) at Week 12|As part of the daily diary for the entire study, patients rated the stiffness in their worst knee using a five-point scale ranging from 1=none to 5=severe. Mean scores summarizing the entries of the preceding period were calculated.|12 weeks|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.||Units on a scale||Standard Deviation|Mean
798820|NCT00950651|Secondary|Patient Diary: Pain (Between Visit Means) at Week 12|As part of the daily diary for the entire study, patients rated the arthritis pain in their worst knee using a five-point scale ranging from 1=none to 5=severe. Mean scores summarizing the entries of the preceding period were calculated.|12 weeks|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.||Units on a scale||Standard Deviation|Mean
798821|NCT00950651|Secondary|Physician Overall Rating: Effectiveness of Pain Control 24 Hours After the Most Recent Dose of Tramadol at Week 12|The physician was asked to indicate the effectiveness of pain control 24 hours after the most recent dose of tramadol using a 4-point Likert-scale, dichotomized for the analysis: Very Effective, Effective, Somewhat Effective were summarized to Effective; Ineffective remained unchanged.|12 weeks|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.||participants|||Number
798822|NCT00950651|Secondary|Physician Overall Rating: Overall Assessment at Week 12|The physician was asked to indicate his overall assessment of the formulation the patient was taking using a 4-point Likert-scale dichotomized for the analysis: Very Effective, Effective, and Somewhat Effective were summarized to Effective; Ineffective remained unchanged.|12 weeks|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.||participants|||Number
798823|NCT00950651|Secondary|Patient Global Assessment: Current Interfering Side Effects Versus Pain Relief During Previous Tramadol Treatment at Week 12|Patients who have previously taken tramadol HCl were asked: “Compared to when you were previously taking tramadol, how have any side effects you have felt during this study interfered with your day-to-day activities?”. Possible answers were: “Interfered much less now”, “Interfered somewhat less now”, “Same as before”, “Interfered more now”.|12 weeks|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.||participants|||Number
798824|NCT00950651|Secondary|Patient Global Assessment: Current Pain Relief Versus Pain Relief During Previous Tramadol Treatment at Week 12|"Patients who have previously taken tramadol HCl were asked to compare how they compare the current pain relief to the pain relief felt when previously taking tramadol, using a 4-point Likert-scale: Worse than before, Same as before, Somewhat better now, or “Much better now”."|12 weeks|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.||participants|||Number
798825|NCT00950651|Secondary|Patient Global Assessment: Side Effects Interfering With Day to Day Activities at Week 12|Patients were asked: “How have any side effects you may have felt from the drug interfered with day-to-day activities?” with 4 possible answers: “Significantly”, “Somewhat”, “Minimally”, “Not at all”.|12 weeks|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.||participants|||Number
798826|NCT00950651|Secondary|Patient Global Rating of Pain Relief at Week 12|"The Patient Global Rating of Pain is a Likert-scale that answers the question: How do you rate overall pain relief with the drug? with 4 possible answers that were dichotomized: very effective, effective, and somewhat effective were summarized to “effective”; “not effective” remained unchanged."|12 Weeks|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.||participants|||Number
798827|NCT00950651|Secondary|Percentage of Change From Baseline in Walking Time for 15 Meters at Week 12|The walking test is a measure of how many seconds it takes the patient to walk a distance of 15 meters. The change from baseline to week 12 was calculated.|Baseline to week 12|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.||percentage of change||Standard Deviation|Mean
798828|NCT00950651|Secondary|Percentage of Change From Baseline in Average Pain Within Last 24 Hours at Week 12|Patients indicated their Average Pain Within Last 24 Hours using a 100mm VAS scale ranging from 0=no pain to 100=extreme pain. The percentage of change was calculated from baseline to week 12. In case of premature discontinuation, the last assessment was used to calculate percentage of change.|Baseline to week 12|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.||percentage of change||Standard Deviation|Mean
798829|NCT00950651|Secondary|Percentage of Change From Baseline in Worst Pain Within Last 24 Hours at Week 12|Patients indicated their Worst Pain Within Last 24 Hours using a 100mm VAS scale ranging from 0=no pain to 100=extreme pain. The percentage of change was calculated from baseline to week 12. In case of premature discontinuation, the last assessment was used to calculate percentage of change.|Baseline to week 12|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.||percentage of change||Standard Deviation|Mean
798842|NCT00950664|Secondary|Reduction of Total TWSTRS Score at 4 Weeks From Baseline|"TWSTRS (Toronto western spasmodic torticollis rating scale) The TWSTRS is a composite scale which covers different features of cervical dystonia(CD).
The first part is based on the physical findings (severity subscale), the second part rates disability, and the third part pain.
(range: 0-80, higher values represent worse cervical dystonia.) Details of the TWSTRS are displayed on the Web site http://www.wemove.org. Negative numbers to represent decreases of TWSTRS."|4 weeks after injection from baseline|||units on a scale||Standard Deviation|Mean
798830|NCT00950651|Secondary|Percentage of Change From Baseline in Least Pain Within Last 24 Hours at Week 12|Patients indicated their Least Pain Within Last 24 Hours using a 100mm VAS scale ranging from 0=no pain to 100=extreme pain. The percentage of change was calculated from baseline to week 12. In case of premature discontinuation, the last assessment was used to calculate percentage of change.|Baseline to week 12|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.||percentage of change||Standard Deviation|Mean
798831|NCT00950651|Secondary|Percentage of Change From Baseline in Current Pain at Week 12|Pain Visual Analogue Scales: Current Pain. Patients indicated their current pain using a 100mm VAS scale ranging from 0=no pain to 100=extreme pain. The percentage of change in current pain was calculated from baseline to week 12. In case of premature discontinuation, the last assessment was used to calculate percentage of change.|Baseline to week 12|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.||percentage of change||Standard Deviation|Mean
798832|NCT00950651|Secondary|Percentage of Change From Baseline in WOMAC Total Score at Week 12|The WOMAC is a statistically validated, 24-item questionnaire assessing current OA symptoms and functional limitations. Each item is rated on a 100mm VAS scale (0mm=no pain/stiffness/difficulty to 100mm=extreme no pain/stiffness/difficulty). In case of premature discontinuation, the last assessment was used to calculate percentage of change.|Baseline to week 12|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.||percentage of change||Standard Deviation|Mean
798833|NCT00950651|Secondary|Percentage of Change From Baseline in WOMAC Physical Function Subscale Score at Week 12|The WOMAC is a statistically validated, 24-item questionnaire assessing current OA symptoms and functional limitations. Physical Function subscale score consists of 17 items rated on a 100mm VAS scale (0mm=no difficulty to 100mm=extreme difficulty). In case of premature discontinuation, the last assessment was used to calculate percentage of change|Baseline to week 12|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.||percentage of change||Standard Deviation|Mean
798834|NCT00950651|Secondary|Percentage of Change From Baseline in WOMAC Stiffness Subscale Score at Week 12|The WOMAC is a statistically validated, 24-item questionnaire assessing current OA symptoms and functional limitations. Stiffness subscale score consists of 2 items each rated on 100mm VAS scale (0mm=no stiffness to 100mm=extreme stiffness). In case of premature discontinuation, the last assessment was used to calculate the percentage of change.|Baseline to week 12|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.||percentage of change||Standard Deviation|Mean
798835|NCT00950651|Secondary|Arthritis Pain at the End of Dosing Interval (24-hour Efficacy)|Each day before morning dose, patients assessed arthritis pain in worst knee in a diary using a 5-point rating scale ranging from none to severe. A median score was estimated for each patient each week and re-categorized into different degrees of pain (rounding off to the closest integer). Results are of 12th week (day 78-84).|12 weeks|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.||participants|||Number
798836|NCT00950651|Primary|Percentage of Change From Baseline in WOMAC Pain Subscale Score at Week 12|The WOMAC is a statistically validated, 24-item questionnaire assessing current OA symptoms and functional limitations. The Pain subscale score consists of 5 items each rated on a 100mm VAS scale (0mm=no pain to 100mm=extreme pain). In case of premature discontinuation, the last assessment was used to calculate the percentage of change.|Baseline to week 12|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.||percentage of change||Standard Deviation|Mean
798837|NCT00950664|Other Pre-specified|Reduction of Pain Associated With Cervical Dystonia at Each Visit From Baseline|Pain subscale of TWSTRS scale.(Range: 0-20) Negative numbers to represent decreases of TWSTRS pain subscale.|4, 8, 12 and 16 weeks after injection|||units on a scale||Standard Deviation|Mean
798838|NCT00950664|Other Pre-specified|Reduction of Total TWSTRS at Each Visit From Baseline|TWSTRS scale (Toronto western spasmodic torticollis rating scale, range: 0-80, higher values represent worse cervical dystonia.) Negative numbers to represent decreases of TWSTRS scale.|8, 12 and 16 weeks after injection|||units on a scale||Standard Deviation|Mean
798839|NCT00950664|Secondary|PGI-I (Patient's Global Impression of Improvement)|"The proportion of patients with 'very much improved' or 'much improved' on the PGI (Patient's global impression of impairment, PGI-I)
1 = very much improved, 2= much improved, 3 = slightly improved, 4 = no change, 5 = slightly aggravated, 6 = much aggravated, and 7 = very much aggravated"|4, 8, 12 and 16 weeks after injection|||percentage of patients scoring 1 or 2|||Number
798840|NCT00950664|Secondary|CGI-I (Clinical Global Impression of Illness)|"The proportion of patients with ‘normal/ not at all ill’ or ‘borderline mildly ill’ on the CGI (Clinical global impression of illness, CGI-I)
1 = normal / not at all ill’; 2 = ‘borderline mildly ill’; 3 = ‘mildly ill’; 4 = ‘moderlately ill’; 5 = ‘markedly ill’; 6 = ‘severely ill’; 7 = ‘the most extremely ill’."|4, 8, 12 and 16 weeks after injection|||percentage of participants scoring 1or2|||Number
798843|NCT00950664|Primary|Reduction of Total Tsui Score at 4 Weeks From Baseline|"Tsui scale is an impairment scale which evaluates the amplitude and duration of sustained posture and intermittent movements of the head, as well as the presence of shoulder elevation and tremor.
Tsui scale (range: 0-25, higher values represent worse cervical dystonia.) Negative numbers to represent decreases of Tsui scale."|4 weeks after injection from baseline|||units on a scale||Standard Deviation|Mean
798844|NCT00950690|Primary|Humphrey Perimetry Visual Field|Analysis of visual field deficits for abnormalities.|Visits 1 and 4|Data collection process did not permit clear identification of IOP & visual field data in non-monitored study. Efficacy data not sufficiently interpretable for statistical summaries.||decibels||Standard Deviation|Mean
798845|NCT00950690|Primary|Intraocular Pressure|Intraocular pressure was measured at each visit|Screening, 10 days, 4 weeks and 12 weeks after beginning treatment|Data collection process did not permit clear identification of IOP & visual field data in non-monitored study. Efficacy data not sufficiently interpretable for statistical summaries.||millimeters of mercury||Standard Deviation|Mean
798846|NCT00950729|Primary|Mean Breaking Force Measured on a Driving Car Simulator|computerized driving simulator was used to measure the braking force during emergency braking with and without distractor|June 2007 to September 2007|||pounds||Standard Deviation|Mean
798847|NCT00950729|Primary|Mean Breaking Time Measured on a Driving Car Simulator|computerized driving simulator was used to measure the braking reaction time and the total braking time during emergency braking with and without a distracter.|June 2007 to September 2007|||seconds||Standard Deviation|Mean
798848|NCT00950742|Secondary|Summary of Concentration of Herceptin in Plasma|Pre-dose Concentrations of Herceptin in Plasma on Days 8, 15 and 29 (Cpre,8, Cpre,15 and Cpre,29) and Maximum Concentration of Herceptin in Plasma on Days 1, 15 and 29 (Cmax,1, Cmax,15 and Cmax,29).|0.05 hours (h) before dosing and 0.5-1h, 2h, 3h, 4h, 5h, 6h, 8h after dosing|Patients with no data available for the relevant parameter and dose were excluded from analysis.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
798849|NCT00950742|Secondary|Time From Dosing to the Maximum Concentration of Afatinib in Plasma at Steady State (Tmax,ss)|tmax,ss represents the time from dosing to the maximum concentration of afatinib in plasma at steady state|0.05 hours (h) before dosing and 0.5-1h, 2h, 3h, 4h, 5h, 6h, 8h after dosing|Patients with no data available for the relevant parameter and dose were excluded from analysis.||hours||Full Range|Median
798850|NCT00950742|Secondary|Summary of Concentration of Afatinib in Plasma|Pre-dose Concentrations of Afatinib in Plasma at Steady State on Days 8, 15 and 29 (Cpre,ss,8, Cpre,ss,15 and Cpre,ss,29) and Maximum Concentration of Afatinib in Plasma at Steady State (Cmax,ss).|0.05 hours (h) before dosing and 0.5-1h, 2h, 3h, 4h, 5h, 6h, 8h after dosing|Patients with no data available for the relevant parameter and dose were excluded from analysis.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
798851|NCT00950742|Secondary|Progression Free Survival (PFS)|PFS is defined as time from randomisation to disease progression or death whichever occurs first. Assessed by central independent review according to the response evaluation criteria in solid tumors (RECIST 1.1). Median time results from unstratified Kaplan-Meier estimates.|Baseline until disease progression, death or data cut-off.|TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.||Days||95% Confidence Interval|Median
798852|NCT00950742|Secondary|Number of Patients With Best Overall Response|Best overall response based on response evaluation criteria in solid tumors (RECIST) version 1.1. Best overall response is defined as complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD) or not evaluable.|Tumor assessment was performed at screening and every 2nd cycle until earliest time of progression, death or end of treatment.|TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.||Participants|||Number
798853|NCT00950742|Secondary|Number of Patients With Objective Response (OR)|Objective tumor response based on response evaluation criteria in solid tumors (RECIST) version 1.1. OR is defined as complete response (CR) or partial response (PR).|Tumor assessment was performed at screening and every 2nd cycle until earliest time of progression, death or end of treatment.|TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.||Participants|||Number
798854|NCT00950742|Primary|Maximum Tolerated Dose (MTD) of Afatinib in Combination With Herceptin(R)|The MTD was defined as the highest dose at which no more than 1 of 6 patients experienced DLT. It was determined using a standard 3 + 3 dose escalation cohort design. To confirm the MTD, the MTD cohort was to be expanded to 18 patients with no more than 3/18 patients experiencing a DLT. Please refer to CAVEATs and Limitations.|28 days|TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib. 3 patients were excluded as they were not evaluable for determination of maximum tolerated dose.||mg|||Number
798855|NCT00950742|Primary|Number of Participants With Dose Limiting Toxicities (DLT)|Number of participants with DLT in the first cycle (28 days) for the determination of the maximum tolerated dose (MTD). Important Limitations and Caveats are provided in the respective section.|28 days|Treated set (TS). TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib. 3 patients were excluded as they were not evaluable for determination of maximum tolerated dose.||Participants|||Number
798856|NCT00950755|Secondary|Number of Days Each Participant Took to Reach Hypothyroidism After the First Dosimetric Dose|Hypothyroidism is a condition in which the thyroid gland does not produce enough thyroid hormone (resulting in the elevation of thyroid stimulating hormone [TSH] in the blood).|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population. Participants experiencing hypothyroidism were analyzed.||days|||Number
798882|NCT00938314|Secondary|Trails A Test Change From Baseline at Day 90|The Trails A test measures visual scanning, numeric sequencing, and visual-motor coordination; the test score is the time (seconds) required to connect 25 numbers (e.g., 1, 2, 3, 4…)|Baseline and Day 90|"Not all patients enrolled in the group completed this outcome measure.
The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug."||seconds||Standard Deviation|Mean
798991|NCT00950937|Primary|Total Glutathione|The total glutathione content in erythrocyte concentrate at three moments: baseline, aerobic and resistance exercise.|3 times - baseline (before the peak oxygen uptake test), aerobic (immediately after aerobic exercise) and resistance (immediately after resistance exercise).|||nmoles glutathione/ ml of sample||Inter-Quartile Range|Median
798857|NCT00950755|Secondary|Number of Participants in the Indicated Categories of Thyroid Function Assessment|Hypothyroidism, a condition in which the thyroid gland does not produce enough thyroid hormone (resulting in the elevation of thyroid stimulating hormone [TSH] in the blood), may result from treatment with radioactive iodine I 131. A thyroid blockade medication was given prior to administration of the study drug and up to 2 weeks after the therapeutic dose to prevent the uptake of I 131 in the thyroid gland. Thyroid function was determined periodically, including during follow-up, in order to assess if there was any effect of the I 131 on thyroid function, such as hypothyroidism.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population. Participants who were evaluable for thyroid function assessment and who had no elevated TSH level or hypothyroidism at baseline were analyzed.||participants|||Number
798858|NCT00950755|Secondary|Time to HAMA Positivity From First Dosimetric Dose|Time to HAMA positivity is defined as the time from the first dosimetric dose to the first reported HAMA-positive result for the participant.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population. Participants who converted to HAMA positivity were analyzed.||days||Full Range|Median
798859|NCT00950755|Secondary|Number of Participants Who Became Positive or Negative for Human Anti-murine Antibody (HAMA) After Study Treatment|Tositumomab is a murine (mouse) antibody. Participants in this study were evaluated to determine if they developed a human anti-murine antibody (HAMA) immune response after administration of tositumomab and iodine I 131 tositumomab.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population||participants|||Number
798860|NCT00950755|Secondary|Nadir Values for Hemoglobin, a Hematologic Parameter|Nadir is defined as the lowest laboratory value recorded following the administration of study medication. Hemoglobin is the iron-containing oxygen-transport metalloprotein in the red blood cells.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population. Only those participants with hematologic toxicity were evaluated. Hematologic toxicity is defined as laboratory values outside the normal range (different for each parameter).||g/dL||Full Range|Median
798861|NCT00950755|Secondary|Nadir Values for Hematologic Parameters ANC, Platelets, and WBC Count|Nadir is defined as the lowest laboratory value recorded following the administration of study medication. ANC is a measure of the number of neutrophil granulocytes present in the blood. Neutrophils are a type of WBC that fights against infection. Platelets and WBCs are types of blood cells.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population. Only those participants with hematologic toxicity were evaluated. Hematologic toxicity is defined as laboratory values outside the normal range (different for each parameter).||1000 cells/millimeters cubed (mm^3)||Full Range|Median
798862|NCT00950755|Secondary|Time to Nadir and Time to Recovery to Baseline in Hematologic Laboratory Evaluations|Nadir is defined as the lowest laboratory value recorded following the administration of the study medication. Time to recovery to baseline in hematologic laboratory evaluations is the time required for recovery from nadir values to baseline values.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population. Only those participants with hematologic toxicity were evaluated for time to nadir and time to recovery to baseline. Hematologic toxicity is defined as laboratory values outside the normal range (different for each parameter).||days||Full Range|Median
798863|NCT00950755|Secondary|Duration of the Indicated Grade 3 or Grade 4 Hematologic Toxicities|Adverse events were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No adverse event or within normal limits; 1 = Mild adverse event; 2 = Moderate adverse event; 3 = Severe and undesirable adverse event; 4 = Life-threatening or disabling adverse event; 5 = Death related to adverse event.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|"ITT Exposed Population. The n in the category titles reflects the number of participants with the indicated Grade 3 or Grade 4 hematologic toxicity."||days||Full Range|Median
798864|NCT00950755|Secondary|Number of Participants With an Infection for Which Anti-infectives Were Administered|Anti-infectives are capable of acting against infection, by inhibiting the spread of an infectious agent or by killing the infectious agent outright. Anti-infective is a general term that encompasses antibacterials, antibiotics, antifungals, antiprotozoans, and antivirals.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population. Only those participants who had infection during the study and during the follow-up period were analyzed.||participants|||Number
798865|NCT00950755|Secondary|Number of Participants With the Indicated Type of Infection|An infection is the colonization of a host organism by a parasite species. Infecting parasites seek to use the host's resources to reproduce, often resulting in disease. Specimen samples of the body fluid are cultured for testing whether the infectious organism is present and grown in the culture media to assess the growth pattern of the organisms present in the specimen. The culture results could be positive or negative. The positive culture results indicate that the tested participant has the infection under investigation, in which case therapeutic treatment with anti-infective is required.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population||participants|||Number
805053|NCT01002339|Secondary|Blood Pressure|Diastolic pressure (mmHg)|1 year|Participants analyzed: participants living with a functioning graft at study end.||mmHg||Standard Deviation|Mean
798866|NCT00950755|Secondary|Number of Participants With the Indicated Serious Adverse Events (SAE) Related to Study Drug|An SAE is any event occurring at any dose that results in any of the following: death, a life-threatening adverse drug experience (ADE; at immediate risk of death from the experience as it occurred), inpatient hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, or a congenital anomaly/birth defect. Medical events that may not result in death, be life-threatening, or require hospitalization may be considered to be a serious ADEs when based upon appropriate medical judgment. Relatedness was based on the Investigator's medical judgement.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population. All participants who experienced any SAE were analyzed.||participants|||Number
798867|NCT00950755|Secondary|Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The Investigator assessed whether the AE was possibly or probably related to study drug. In addition, all laboratory-derived hematologic toxicities were assumed to be possibly or probably related to study drug.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population||participants|||Number
798868|NCT00950755|Secondary|Overall Survival|Overall survival is defined as the time from the treatment start date to the date of death from any cause.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|Only those participants who died during the study and during the follow-up period were analyzed.||months||95% Confidence Interval|Median
798869|NCT00950755|Secondary|Time to Treatment Failure as Assessed by the Investigator|Time to treatment failure is defined as the length of time from the date of enrollment to the first incidence of treatment withdrawal, study removal, progression, and/or alternative therapy for the participant's lymphoma, or death.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population. Only those participants who experienced treatment failure were evaluated.||months||95% Confidence Interval|Median
798870|NCT00950755|Secondary|Time to Progression of Disease or Death as Assessed by the Investigator|Time to progression or progression-free survival is defined as the time from the dosimetric dose to the first documented occurrence of disease progression or death. Disease progression is defined as a >=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. New lesions must be greater than 2 x 2 centimeters (cm) in diameter by radiographic evaluation or greater than 1 cm in diameter by physical examination.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population. Only those participants who experienced progression were evaluated.||months||95% Confidence Interval|Median
798871|NCT00950755|Secondary|Duration of Response for All Confirmed Responders (CR, CCR, or PR) as Assessed by the Investigator|Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Duration of response is defined as the time from the first documented response until disease progression. Disease progression is defined as a >=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be >2 cm in diameter by radiographic evaluation or >1 cm in diameter by physical examination.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population. Only those participants with confirmed response and those who experienced progressive disease were analyzed.||months||95% Confidence Interval|Median
798872|NCT00950755|Primary|Number of Participants With Confirmed Partial Response (PR) as Assessed by the Investigator|Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Confirmed PR is defined as a >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions, with no new lesions.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population. Only those participants evaluable for confirmed PR were analyzed.||participants|||Number
798873|NCT00950755|Primary|Number of Participants With Confirmed Complete Response Plus Clinical Complete Response (CR + CCR) as Assessed by the Investigator|Responses had to be confirmed by 2 separate evaluations occurring >4 weeks apart. CCR is defined as the complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present. Generally, an unchanging lesion =<2 centimeters (cm) in diameter by radiographic evaluation or =<1 cm in diameter by physical examination can be considered scar tissue. The extent of disease (EOD) must be unchanged or decreased upon follow-up evaluations. If the EOD was unchanged or if further decreases occurred for >=6 months, the participant was reclassified as having a CR.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population. Only those participants evaluable for CR + CCR were analyzed.||participants|||Number
798874|NCT00950755|Primary|Number of Participants With Confirmed Complete Response (CR) as Assessed by the Investigator|Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. CR is defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population. Only those participants evaluable for confirmed response were analyzed.||participants|||Number
798875|NCT00950755|Primary|Number of Participants With Confirmed Response as Assessed by the Investigator|Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Par. with confirmed response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population. Only those participants evaluable for confirmed response were analyzed.||participants|||Number
798876|NCT00950755|Primary|Number of Participants (Par.) With Response as Assessed by the Investigator|Par. with response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|Intent-to-Treat (ITT) Exposed Population: all participants who were enrolled into the study and received at least one dose of study drug. Only those participants evaluable for response were analyzed.||participants|||Number
798877|NCT00950807|Secondary|Change From Baseline (BL) in Serial FEV1 Over 0-28 Hours After the Morning Dose at Day 14 of Each Treatment Period|Serial FEV1 for OQ dosing is recorded at the pre-AM dose (time 0 h) and at 1, 3, 6, 9, 12,13, 15, 18, 21, 24 and 28 hs after the AM dose on D 14. For BID dosing, the 12 h AM dose corresponds to the pre-PM dose, 13 h AM dose corresponds to the 1 h PM dose, 15 h AM dose corresponds to the 3 h PM dose, 18 h AM corresponds to the 6 h PM dose, 21 h AM dose corresponds to 9 h PM dose, 24 h AM dose corresponds to the 12 h PM dose and 28 h AM dose corresponds to the 16 h PM dose in the table. Analysis performed using a mixed model with covariates of mean BL, period BL, trt, period, time, time by period BL interaction, time by mean BL interaction and time by trt interaction as fixed effects and par. as a random effect. BL is the FEV1 value recorded pre-dose on D 1 of each TP; mean BL is the mean of the BLs for each par. and period BL is the difference between the BL and the mean BL in each TP for each par. Change from BL for each TP is the trough FEV1 at Day 15 minus the BL value for that TP.|Baseline and Day (D) 14 of each treatment period (TP; up to Study Day 70)|mITT Population. All par. with >=1 post-BL assessment and non-missing covariate data are included in the analysis. Different par. may have been analyzed at different time points (n=X, X, X, X in the category titles), so the overall number of par. analyzed reflects everyone in the mITT Population with data available at >=1 time point.||Liters||Standard Deviation|Mean
798878|NCT00950807|Secondary|Change From Baseline (BL) in Weighted Mean FEV1 Over 0 to 24 Hours Obtained Post-dose on Day 14 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The weighted mean FEV1 was derived by calculating the area under the FEV1/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. The weighted mean FEV1 was calculated using 0-24 hour (h) post-dose measurements at Day 14 of each treatment period, which included pre-dose and post-dose 1, 3, 6, 9, 12, 13, 15, 18, 21 and 24 hours. Analysis performed using a mixed model with covariates mean BL, period BL, treatment and period as fixed effects and participant as a random effect. BL is the FEV1 value recorded pre-dose on Day 1 of each TP; mean BL is the mean of the BLs for each participant and period BL is the difference between the BL and the mean BL in each TP for each participant. Change from BL for each TP is the trough FEV1 at Day 15 minus the BL value for that TP.|Baseline and Day 14 of each treatment period (TP; up to Study Day 70)|mITT Population. All participants with >=1 post-Baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 14.||Liters||Standard Error|Least Squares Mean
798879|NCT00950807|Primary|Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Day 15 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Treatment Day 15 is defined as the value obtained 24 hours after the morning dose administered on Day 14. Analysis were performed using a mixed model with covariates of mean Baseline, period Baseline, treatment and period as fixed effects and participant as a random effect. Baseline is the FEV1 value recorded pre-dose on Day 1 of each treatment period; mean Baseline is the mean of the Baselines for each participant and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Change from Baseline for each treatment period is the trough FEV1 at Day 15 minus the Baseline value for that treatment period.|Baseline and Day 15 of each treatment period (up to Study Day 71)|Modified Intent-To-Treat (mITT) Population: all participants randomized to treatment who received at least one dose of study medication. All participants with >=1 post-baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 15.||Liters||Standard Error|Least Squares Mean
798880|NCT00938314|Secondary|Geriatric Depression Scale at Day 90|The Geriatric Depression Scale is commonly used to assess depression in stroke patients of any age by asking 15 yes/no questions, and then scored. A score of 0 – 5 is normal, whereas a score of 6 -15 suggests depression.|Day 90|"Not all patients enrolled in the group completed this outcome measure.
The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug."||scores on a scale||Standard Deviation|Mean
798881|NCT00938314|Secondary|Trails B Test Change From Baseline at Day 90|The Trails B test measures visual scanning, numeric sequencing, and visual-motor coordination; the test score is the time (seconds) required to connect 25 alpha numeric circles (e.g., 1, A, 2, B, 3, C, 4, D)|Baseline and Day 90|"Not all patients enrolled in the group completed this outcome measure.
The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug."||seconds||Standard Deviation|Mean
812453|NCT01070784|Primary|Vital Signs- Sitting Systolic Blood Pressure(SBP)|Change from baseline|Baseline and 52 week after|||mmHg||Standard Deviation|Mean
798883|NCT00938314|Secondary|Line Cancellation Test Change From Baseline at Day 90|The Line Cancellation Test detects the loss of awareness of one side of the body. A score of 0.00 (no units) is normal (patient favors neither right nor left side). A score of +1.00 indicates severe unawareness of the left side. A score of -1.00 indicates severe unawareness of the right side.|Baseline and Day 90|"Not all patients enrolled in the group completed this outcome measure.
The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug."||scores on a scale||Standard Deviation|Mean
798884|NCT00938314|Secondary|Boston Naming Test (BNT) Change From Baseline at Day 90|The BNT assesses impairment of language ability by asking patients to identify 20 different pictures each time the test is taken. A score of 20 is best, 0 is worst.|Baseline and Day 90|"Not all patients enrolled in the group completed this outcome measure.
The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug."||Scores on a scale||Standard Deviation|Mean
798885|NCT00938314|Secondary|Gait Velocity Test Change From Baseline at Day 90|The Gait Velocity Test assesses ability to walk as measured by the time (seconds) it takes a patient to walk 10 meters.|Baseline and Day 90|"Not all patients enrolled in the group completed this outcome measure.
The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug."||seconds||Standard Deviation|Mean
798886|NCT00938314|Secondary|Action Research Arm Test (ARAT) Change From Baseline at Day 90|The ARAT assesses recovery of arm function following stroke through a series of subtests judging ability to grasp, grip, pinch, or move the arm; scores are on a scale; The total maximum (best) score is 57 and the total minimum (worst) score is 0.|Baseline and Day 90|"Not all patients enrolled in the group completed this outcome measure.
The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug."||scores on a scale||Standard Deviation|Mean
798887|NCT00938314|Secondary|Barthel Index at Day 90|The Barthel Index measures 10 activities of daily living and mobility. A score of 100 = is best (able to live at home with a degree of independence), 0 is worst.|Day 90|The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug.||Scores on a scale||Standard Deviation|Mean
798888|NCT00938314|Secondary|Modified Rankin Scale (mRS) Response <=2 at Day 90|The mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke. The scale runs from 0 (perfect health without symptoms) to 6 (dead). mRS response <=2 is defined as the mRS score <=2 at Day 90.|Day 90|The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug.||participants|||Number
798889|NCT00938314|Secondary|NIHSS Change From Baseline at Day 30|The NIHSS is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42 (dead).|Baseline and Day 30|The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug.||scores on a scale||Standard Deviation|Mean
798890|NCT00938314|Secondary|NIHSS Response >=4 at Day 90|The NIHSS is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42 (dead). NIHSS Response >=4 is defined as a >=4 change from baseline at Day 90.|Baseline and Day 90|The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug.||participants|||Number
798891|NCT00938314|Primary|National Institutes of Health Stroke Scale (NIHSS) Change From Baseline at Day 90|The NIHSS is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42 (dead).|Baseline and Day 90|The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug.||scores on a scale||Standard Deviation|Mean
798892|NCT00938327|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Throughout the study period (from Day 0 up to Day 30)|Analysis was performed on the Total Vaccinated Cohort.||subjects|||Number
798893|NCT00938327|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31-day (Day 0 – Day 30) follow-up period after each vaccination|Analysis was performed on the Total Vaccinated Cohort.||subjects|||Number
798894|NCT00938327|Secondary|Number of Subjects Reporting Solicited General Symptoms|Cough: Cough/runny nose of any intensity Diarrhoea: Passage of three or more looser than normal stools within a day Irritability: Cried more than usual Loss of appetite: Ate less than usual Temperature: Axillary temperature greater than or equal to 37.5°C Vomiting: One or more episodes of forceful emptying of partially digested stomach contents ≥ 1 hour after feeding within a day|During the 8-day (Day 0 – Day 7) follow-up period after each vaccination|Analysis was performed on the Total Vaccinated Cohort.||subjects|||Number
798895|NCT00938327|Primary|Number of Subjects Reporting Grade 2 or 3 Symptoms (Fever, Vomiting or Diarrhoea)|"Grade 2 fever was defined as axillary temperature above 38.0 degrees Celsius (°C) and below or equal to 39.0°C.
Grade 3 fever was defined as axillary temperature above 39.0°C. Grade 2 vomiting was defined as 2 episodes of vomiting per day. Grade 3 vomiting was defined as at least 3 episodes of vomiting per day. Grade 2 diarrhoea was defined as 4-5 looser than normal stools per day. Grade 3 diarrhoea was defined as at least 6 looser than normal stools per day."|During the 8-day (Day 0 – Day 7) follow-up period after each vaccination.|Analysis was performed on the Total Vaccinated Cohort.||subjects|||Number
798896|NCT00943683|Primary|Number of Clinical Adverse Experiences (CAEs) Reported by Patients During the 6-weeks of Treatment|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|During the 6 weeks of treatment|All patients who took study medication were included in the analysis.||Participants|||Number
801534|NCT00967694|Primary|Change in Intraocular Pressure During Nitrous Oxide Sedation||Before, during and after administration of nitrous oxide (45 minutes total)|||mmHg (difference in IOP)||95% Confidence Interval|Mean
798906|NCT00943735|Secondary|Comparison of Percentage of Participants Who Agreed That They Had a Good Understanding About Their Condition and How to Treat it, Between Enrollment Date and End of Study CATI Interview||Enrollment (Day 0) up to 90 days|PP population; (n)=CATI response valid n at observation. Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid n, therefore, may have varied from response to response.||percentage of participants||95% Confidence Interval|Number
798907|NCT00943735|Secondary|Percentage of Participants Who Agreed That They Had a Good Understanding About Their Condition and How to Treat it||Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.||percentage of participants||95% Confidence Interval|Number
798908|NCT00943735|Secondary|Percentage of Participants Who Reported the YourWay Plan Encouraged Their Use of Toviaz® (Fesoterodine)||Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.||percentage of participants||95% Confidence Interval|Number
798909|NCT00943735|Secondary|Percentage of Participants Who Reported They Were Satisfied With Their Physician||Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.||percentage of participants||95% Confidence Interval|Number
798910|NCT00943735|Secondary|Percentage of Participants Who Reported They Were Satisfied With the Treatment Goals and Bladder Symptoms Progress Trackers|"Treatment goals and bladder symptoms progress trackers were incorporated in the 12 Week Tracker which included a participant determined weekly goal, a reminder to fill the prescription (if appropriate interval), participant reported progress in response to this week I did well at, and a 7-day Daily Core 4 Tracker checklist (food and drink, teach your bladder, daily fesoterodine, and track your progress)."|Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.||percentage of participants||95% Confidence Interval|Number
798911|NCT00943735|Secondary|Percentage of Participants Who Reported They Were Satisfied With the Participant Support Telephone Calls|YourWay participants received 6 telephone calls from an automated speech-recognition system over a period of approximately 11 weeks. The calls included reinforcement of treatment participation, treatment expectations, compliance, general health messages regarding OAB, review of training materials, optional weekly email communication, and a wrap-up call which included a summary of lessons learned from each of the Core 4 lessons calls and guidance to find additional information about medication and lifestyle tips to support management of OAB symptoms.|Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.||percentage of participants||95% Confidence Interval|Number
798912|NCT00943735|Secondary|Percentage of Participants Who Reported They Were Satisfied With the Overall Content of the YourWay Plan||Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.||percentage of participants||95% Confidence Interval|Number
798913|NCT00943735|Secondary|Percentage of Participants Who Reported They Felt Confident That They Could Manage Their OAB as a Result of the YourWay Plan||Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.||percentage of participants||95% Confidence Interval|Number
798914|NCT00943735|Secondary|Percentage of Participants Who Agreed That They Understand OAB is a Chronic Condition That Can be Successfully Managed, But Generally Not Cured||Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.||percentage of participants||95% Confidence Interval|Number
798915|NCT00943735|Secondary|Percentage of Participants Who Agreed That They Increased Their Knowledge of Healthy Bladder Behaviors|The use of the YourWay plan was optional but was available to all participants and included healthy bladder behaviors such as setting and maintaining personal goals and choice of bladder-friendly food and drinks.|Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.||percentage of participants||95% Confidence Interval|Number
798916|NCT00943735|Secondary|Percentage of Participants Who Agreed That They Learned Something About Their Condition||Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.||percentage of participants||95% Confidence Interval|Number
798992|NCT00950937|Secondary|Catalase Activity|Antioxidant activity of the catalase enzyme at three moments: baseline, aerobic and exercise.|3 times - baseline (before the peak oxygen uptake test), aerobic (immediately after aerobic exercise) and resistance (immediately after resistance exercise).|||units of catalase /mg protein||Inter-Quartile Range|Median
798917|NCT00943735|Secondary|Percentage of Participants Who Agreed That They Understood What to Expect From Their OAB Medication, Toviaz® (Fesoterodine)|Product indication and safety information was provided to all participants by the investigator and / or within the YourWay plan program information.|Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.||percentage of participants||95% Confidence Interval|Number
798918|NCT00943735|Secondary|Percentage of Participants Who Agreed That the YourWay Plan Helped Them Play a More Active Role in Managing Their Condition||Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.||percentage of participants||95% Confidence Interval|Number
798919|NCT00943735|Secondary|Percentage of Participants Who Agreed That They Were Able to Incorporate the YourWay Plan Into Their Lives||Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.||percentage of participants||95% Confidence Interval|Number
798920|NCT00943735|Secondary|Percentage of Participants Who Agreed That the YourWay Plan Provided a Strong Support System That Participants Could Count on for Information and Advice|YourWay participants received 6 telephone calls from an automated speech-recognition system over a period of approximately 11 weeks. The calls included reinforcement of treatment participation, treatment expectations, compliance, general health messages regarding OAB, review of training materials, optional weekly email communication, and a wrap-up call which included a summary of lessons learned from each of the Core 4 lessons calls and guidance to find additional information about medication and lifestyle tips to support management of OAB symptoms.|Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.||percentage of participants||95% Confidence Interval|Number
798921|NCT00943735|Secondary|Percentage of Participants Who Agreed That the YourWay Program Provided a Good Amount of Information||Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.||percentage of participants||95% Confidence Interval|Number
798922|NCT00943735|Secondary|Percentage of Participants Who Agreed That They Found the YourWay Program Materials Easy to Understand||Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.||percentage of participants||95% Confidence Interval|Number
798923|NCT00943735|Secondary|Percentage of Participants Who Reported That They Let Their Doctor Know How They Were Doing With the YourWay Plan|Participants were recruited for study participation when they presented with OAB symptoms during regularly-scheduled physician visits; screening and enrollment occurred during the same visit. Follow-up visits could be scheduled per standard clinical practice.|Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.||percentage of participants||95% Confidence Interval|Number
798924|NCT00943735|Secondary|Percentage of Participants Who Reported That They Kept Track of Symptoms in the 12 Week Tracker Bladder Diary|"For each week, the 12 Week Tracker included a participant determined weekly goal, a reminder to fill the prescription (if appropriate interval), participant reported progress in response to this week I did well at, and a 7-day Daily Core 4 Tracker checklist (food and drink, teach your bladder, daily fesoterodine, and track your progress)."|Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.||percentage of participants||95% Confidence Interval|Number
798925|NCT00943735|Secondary|Percentage of Participants Who Reported That They Recorded Their Treatment Goals in the Daily Core 4 Tracker|"YourWay Daily Core 4 Tracker to track daily progress in the 4 core areas of food and drink (make more informed choices), teach your bladder (train your bladder to wait), daily Toviaz® (always take as directed), and keep track (share with your doctor)."|Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.||percentage of participants||95% Confidence Interval|Number
798926|NCT00943735|Secondary|Percentage of Participants Who Reported That They Took Toviaz® (Fesoterodine) as Directed||Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.||percentage of participants||95% Confidence Interval|Number
798990|NCT00950937|Secondary|Glutathione S-transferase (GST)|Antioxidant activity of the Glutathione S-transferase enzyme at three moments: baseline, aerobic and resistance exercise.|3 times - baseline (before the peak oxygen uptake test), aerobic (immediately after aerobic exercise) and resistance (immediately after resistance exercise).|||micromol of GST/min/mg of protein||Inter-Quartile Range|Median
805054|NCT01002339|Secondary|Blood Pressure|Systolic pressure (mmHg)|1 year|Participants analyzed: participants living with a functioning graft at study end.||mmHg||Standard Deviation|Mean
798927|NCT00943735|Secondary|"Percentage of Participants Who Reported That They Trained Their Bladder to Wait"|"The use of the YourWay plan was optional but was available to all participants and included bladder training techniques such as to urinate each day when getting up and before going to bed, gradually increasing the amount of time between urinating, staying with timing goals whether there was a need to urinate or not, and bladder control tips (such as pelvic floor muscle squeeze, sit down and take 5 deep breaths, or stating I'm the boss - not my bladder)."|Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.||percentage of participants||95% Confidence Interval|Number
798928|NCT00943735|Secondary|Percentage of Participants Who Reported That They Made Bladder-friendly Food and Drink Choices|The use of the YourWay plan was optional but was available to all participants and included bladder-friendly food and drink choices and recipes as well as information for maintaining hydration and avoidance of potential bladder irritants (such as caffeine, citrus fruits and juices, artificial sweeteners, tomato-based foods, soda, alcohol, and spicy foods).|Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.||percentage of participants||95% Confidence Interval|Number
798929|NCT00943735|Secondary|Percentage of Participants Who Reported Having Adopted Lifestyle Changes to Help Improve Their Overactive Bladder (OAB) Symptoms|The use of the YourWay plan was optional but was available to all participants and included guidance for food and drink choices, bladder training, treatment compliance, and use of a daily tracker.|Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.||percentage of participants||95% Confidence Interval|Number
798930|NCT00943735|Secondary|Percentage of Participants Who Reported Having Read the YourWay Plan Materials Received From Their Physician or From the Resource Kit|YourWay plan included a starter pack with a 14-day supply of 4 mg or 8 mg fesoterodine; guidebook for YourWay plan components and lifestyle modification tips; plan progress tracker with additional lifestyle tips; plan enrollment form. About 1 week after plan enrollment, participants received a resource kit by mail which included: a cover letter; brochures for “Core 4” elements (food and drink, teach your bladder, daily fesoterodine, and track your progress); bladder diary and “track your progress” brochure; and recipes using bladder-friendly foods.|Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.||percentage of participants||95% Confidence Interval|Number
798931|NCT00943735|Secondary|Among Participants Who Used the YourWay Website, the Percentage of Participants Who Agreed That the Website Was Useful||Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.||percentage of participants||95% Confidence Interval|Number
798932|NCT00943735|Secondary|Percentage of Participants Who Visited the YourWay Website|YourWay plan was available and accessible to all participants prescribed fesoterodine, but was not defined as an explicit or required component. Plan included motivational support for taking fesoterodine and behavioral interventions shown in clinical studies to improve participants’ Overactive Bladder (OAB) outcomes. Objectives included intervening quickly after treatment initiation, before participants had an opportunity to discontinue medication, reinforcing the treatable nature of OAB, and setting appropriate expectations for onset of action with therapy and degree of symptom improvement.|Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.||percentage of participants||95% Confidence Interval|Number
798933|NCT00943735|Secondary|Percentage of Participants Who Filled at Least Two Fesoterodine Prescriptions (First Refill) During the Study Period|The prototypical pattern was to fill 3 separate prescriptions, each for a 30-day supply, between the enrollment date and Day 90 of the study period; these prescription fills could happen as early as Day 0, 30, and 60 of the study period. At enrollment, the Investigator provided participants with a prescription for fesoterodine 4mg or 8mg to be filled at a pharmacy of their choice. The first refill indicated that 2 fesoterodine prescriptions had been filled.|Enrollment (Day 0) up to 90 days|PP population||percentage of participants||95% Confidence Interval|Number
798934|NCT00943735|Secondary|Percentage of Participants Who Filled at Least One Fesoterodine Prescription During the Study Period (Primary Adherence)|The prototypical pattern was to fill 3 separate prescriptions, each for a 30-day supply, between the enrollment date and Day 90 of the study period; these prescription fills could happen as early as Day 0, 30, and 60 of the study period. Primary adherence was met if the participant filled at least 1 fesoterodine prescription during the study period.|Enrollment (Day 0) up to 90 days|PP population||percentage of participants||95% Confidence Interval|Number
798946|NCT00950833|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as causally related to study vaccination. This outcome measure refers only to the unprimed group.|During the 4-day (Days 0-3) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.||Participants|||Count of Participants
798935|NCT00943735|Primary|Percentage of Participants Who Filled at Least 90 Days Supply of Fesoterodine (4mg QD or 8mg QD) Within 90 Days of Study Enrollment|Prototypical pattern for meeting primary endpoint was to fill 3 separate prescriptions (Rx), each for a 30-day supply between enrollment and Day 90. Rx fills could happen as early as Day 0, 30, and 60 of the study period. Participants could also have chosen to wait until their 14-day medication sample was exhausted before receiving their first fill. Investigators received no prescribing restrictions, but were advised not to write Rx for a 90-day supply of fesoterodine at enrollment visit. Participants whose first observed Rx was for a ≥90-day supply were non-evaluable for the primary endpoint.|Enrollment (Day 0) up to 90 days|Per Protocol (PP) population: all participants who returned a signed informed consent form (Intent to Treat) and enrollment questionnaire, had evidence of ≥1 prescription in LRx database for any medication class, and did not receive an initial fesoterodine prescription for ≥ a 90-day supply.||percentage of participants||95% Confidence Interval|Number
798936|NCT00950833|Secondary|Number of Subjects With New Acquisition of H. Influenzae in Nasopharyngeal Swabs|Frequency of acquisition of new H. influenzae strains in the nasopharynx was done per group at the same swab time-point.|At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age|The analysis was performed on the ATP cohort for carriage, which included all evaluable subjects for whom carriage outcome measures were available after the swab time point.||Participants|||Count of Participants
798937|NCT00950833|Secondary|Number of Subjects With New Acquisition of S. Pneumoniae (Non-vaccine and Non-cross-reactive Serotypes) in Nasopharyngeal Swabs|Frequency of acquisition of new non- vaccine, non-cross-reactive serotypes in the nasopharynx was done per group at the same swab time-point.|At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age|The analysis was performed on the ATP cohort for carriage, which included all evaluable subjects for whom carriage outcome measures were available after the swab time point.||Participants|||Count of Participants
798938|NCT00950833|Secondary|Number of Subjects With New Acquisition of S. Pneumoniae (Cross-reactive Serotypes) in Nasopharyngeal Swabs|Frequency of acquisition of new cross-reactive serotypes in the nasopharynx was done per group at the same swab time-point.|At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age|The analysis was performed on the ATP cohort for carriage, which included all evaluable subjects for whom carriage outcome measures were available after the swab time point.||Participants|||Count of Participants
798939|NCT00950833|Secondary|Number of Subjects With New Acquisition of S. Pneumoniae (Vaccine Serotypes) in Nasopharyngeal Swabs|Frequency of acquisition of new Synflorix™ vaccine serotypes in the nasopharynx was done per group at the same swab time-point.|At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age|The analysis was performed on the ATP cohort for carriage, which included all evaluable subjects for whom carriage outcome measures were available after the swab time point.||Participants|||Count of Participants
798940|NCT00950833|Secondary|Number of Nasopharyngeal Swabs With Haemophilus Influenzae|Positive cultures of H. influenzae identified in the nasopharynx were recorded and the percentage of subjects with positive nasopharyngeal samples was calculated.|At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age|The analysis was performed on the ATP cohort for carriage, which included all evaluable subjects for whom carriage outcome measures were available after the swab time point.||Swabs|||Number
798941|NCT00950833|Secondary|Number of Nasopharyngeal Swabs With S.Pneumoniae (Non-vaccine and Non-cross-reactive Serotypes)|Positive cultures of S. pneumoniae non- Synflorix™ vaccine, non-cross-reactive serotypes identified in the nasopharynx were recorded and the percentage of subjects with positive nasopharyngeal samples was calculated.|At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age|The analysis was performed on the ATP cohort for carriage, which included all evaluable subjects for whom carriage outcome measures were available after the swab time point.||Swabs|||Number
798942|NCT00950833|Secondary|Number of Nasopharyngeal Swabs With S.Pneumoniae (Cross-reactive Serotypes)|Positive cultures of S. pneumoniae cross- reactive serotypes identified in the nasopharynx were recorded and the percentage of subjects with positive nasopharyngeal samples was calculated.|At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age|The analysis was performed on the ATP cohort for carriage, which included all evaluable subjects for whom carriage outcome measures were available after the swab time point.||Swabs|||Number
798943|NCT00950833|Secondary|Number of Nasopharyngeal Swabs With Streptococcus Pneumoniae (Vaccine Serotypes)|Positive cultures of S. pneumoniae Synflorix™ vaccine serotypes identified in the nasopharynx were recorded and the percentage of subjects with positive nasopharyngeal samples was calculated.|At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age|The analysis was performed on the ATP cohort for carriage, which included all evaluable subjects for whom carriage outcome measures were available after the swab time point.||Swabs|||Number
798944|NCT00950833|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Day 0 up to Month 10 or Month 12)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.||Participants|||Count of Participants
798945|NCT00950833|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within 31 days (Days 0-30) after each vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.||Participants|||Count of Participants
798957|NCT00950833|Secondary|Antibody Concentrations Against Protein D (Anti-PD)|Anti-protein D (anti-PD) concentrations were presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off value of the assay was an antibody concentration ≥ 100 EL.U/mL.|Prior to (Day 0) and 7-10 days after the first vaccine dose|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against protein D were available after vaccination.||EL.U/mL||95% Confidence Interval|Geometric Mean
798947|NCT00950833|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as causally related to study vaccination. This outcome measure refers only to the primed groups.|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.||Participants|||Count of Participants
798948|NCT00950833|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site. This outcome measure refers only to the unprimed group.|During the 4-day (Days 0-3) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.||Participants|||Count of Participants
798949|NCT00950833|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site. This outcome measure refers only to the primed groups.|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.||Participants|||Count of Participants
798950|NCT00950833|Secondary|Rabbit Complement-mediated Serum Bactericidal Activity Titers Against Neisseria Meningitidis Serogroups (rSBA-Men)|The Neisseria meningitidis serogroups assessed using rabbit complement were: A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY), presented as geometric mean titers (GMTs). The seropositivity cut-off of the assay was an antibody titer ≥ 8.|At 25-36 months post-vaccination in previous 107137 (NCT00496015) study|The analysis was performed on the ATP cohort for antibody persistence, which included all subjects with the vaccine administration documented, for whom assay results were available for antibodies against each considered antigen for the blood sample taken before the administration of Synflorix™ vaccine.||Titers||95% Confidence Interval|Geometric Mean
798951|NCT00950833|Secondary|Antibody Concentrations Against Protein D (Anti-PD)|Anti-protein D (anti-PD) concentrations were presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off value of the assay was an antibody concentration ≥ 100 EL.U/mL.|At Month 12, one month after the second vaccine dose|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against protein D were available after vaccination.||EL.U/mL||95% Confidence Interval|Geometric Mean
798952|NCT00950833|Secondary|Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A|Seropositivity status was defined as the opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A (opsono-16A and opsono-19A) ≥ the value of 8, presented as geometric mean titers (GMTs).|At Month 12, one month after the second vaccine dose|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one pneumococcal vaccine serotype were available after vaccination.||Titers||95% Confidence Interval|Geometric Mean
798953|NCT00950833|Secondary|Antibody Concentrations Against Vaccine Pneumococcal Cross-reactive Serotypes 6A and 19A|The vaccine pneumococcal cross-reactive serotypes 6A and 19A have been assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in μg/mL. The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.|At Month 12, one month after the second vaccine dose|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one pneumococcal vaccine serotype were available after vaccination.||μg/mL||95% Confidence Interval|Geometric Mean
798954|NCT00950833|Secondary|Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes|Seropositivity status was defined as the opsonophagocytic activity (OPA) against pneumococcal serotypes ≥ the value of 8, presented as geometric mean titers (GMTs). The vaccine pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Opsono-1, -4, -6B, -7F, -9V, -14, -18C, -19F and -23F).|At Month 12, one month after the second vaccine dose|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one pneumococcal vaccine serotype were available after vaccination.||Titers||95% Confidence Interval|Geometric Mean
798955|NCT00950833|Secondary|Antibody Concentrations Against Vaccine Pneumococcal Serotypes|The vaccine pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs), expressed in μg/mL. The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.|At Month 12, one month after the second vaccine dose|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one pneumococcal vaccine serotype were available after vaccination.||μg/mL||95% Confidence Interval|Geometric Mean
798956|NCT00950833|Secondary|Memory B-cell Detection for Vaccine Polysaccharides (PS)|B-cell detection for the pneumococcal serotype specific polysaccharides (1, 5, 6B, 18C, 19F, 23F and C) was tabulated for a subset of subjects from each group. The results are expressed as the frequencies of antigen-specific memory B-cells within the total memory B-cell population.|Prior to (Day 0) and 7-10 days after the first vaccine dose|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one pneumococcal vaccine serotype were available after vaccination.||Memory B-cells||Standard Deviation|Mean
798958|NCT00950833|Secondary|Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A|Seropositivity status was defined as the opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A (Opsono-16A and opsono-19A) ≥ the value of 8, presented as geometric mean titers (GMTs).|Prior to (Day 0) and 7-10 days after the first vaccine dose|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one pneumococcal vaccine serotype were available after vaccination.||Titers||95% Confidence Interval|Geometric Mean
798959|NCT00950833|Secondary|Antibody Concentrations Against Vaccine Pneumococcal Cross-reactive Serotypes 6A and 19A|The vaccine pneumococcal cross-reactive serotypes 6A and 19A have been assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in μg/mL. The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.|Prior to (Day 0) and 7-10 days after the first vaccine dose|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one pneumococcal vaccine serotype were available after vaccination.||μg/mL||95% Confidence Interval|Geometric Mean
798960|NCT00950833|Secondary|Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes|Seropositivity status was defined as the opsonophagocytic activity (OPA) against pneumococcal serotypes ≥ the value of 8, presented as geometric mean titers (GMTs). The vaccine pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Opsono-1, -4, -6B, -7F, -9V, -14, -18C, -19F and -23F).|Prior to (Day 0) and 7-10 days after the first vaccine dose|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one pneumococcal vaccine serotype were available after vaccination.||Titers||95% Confidence Interval|Geometric Mean
798961|NCT00950833|Secondary|Antibody Concentrations Against Vaccine Pneumococcal Serotypes|Antibody concentrations against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -6B, -7F, -9V, -14, -18C, -19F and -23F) have been assessed by 22F-inhibition ELISA, presented as GMCs and expressed in μg/mL. The seropositivity cut-off value of the assay was an antibody concentration ≥ 0.05 μg/mL.|Prior to the first study vaccine dose (At Day 0)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one pneumococcal vaccine serotype were available after vaccination.||μg/mL||95% Confidence Interval|Geometric Mean
798962|NCT00950833|Primary|Antibody Concentrations Against Vaccine Pneumococcal Serotypes|Antibody concentrations against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -6B, -7F, -9V, -14, -18C, -19F and -23F) have been assessed by 22F-inhibition enzyme linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.05 μg/mL.|At 7-10 days after the first vaccine dose|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one pneumococcal vaccine serotype were available after vaccination.||μg/mL||95% Confidence Interval|Geometric Mean
798963|NCT00950859|Secondary|Number of Participants With the Indicated Grade 3 and Grade 4 Hematological Toxicities|Hematology and clinical chemistry data were summarized according to Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, dated December 2004. Grade 1, Mild; Grade 2, Moderate; Grade 3, Severe; Grade 4, Potentially life-threatening. Data are presented for only those parameters for which an increase to Grade 3 or Grade 4 occurred. The Grade 3 and Grade 4 hematological toxicities included: Hemoglobin, Platelet Count, Total Neutrophils, and White Blood Cell count.|From start of study treatment until the end of treatment visit for each participant, up to Week 264 for Cohort I and up to Week 228 for Cohort II|Safety Population: all participants that took at least one dose of DTG||Participants|||Number
798964|NCT00950859|Secondary|Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities|Hematology and clinical chemistry data were summarized according to Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, dated December 2004. Grade 1, Mild; Grade 2, Moderate; Grade 3, Severe; Grade 4, Potentially life-threatening. Data are presented for only those parameters for which an increase to Grade 3 or Grade 4 occurred. The Grade 3 and Grade 4 clinical chemistry toxicities included: Albumin, Alkaline Phosphatase, Amylase, Aspartate Amino Transferase, Carbon dioxide content/Bicarbonate, Creatinine, Creatinine Clearance, Hypercalcemia, Hyperglycaemia, Hyperkalemia, Hypernatremia, Hypocalcemia, Hypoglycaemia, Hypokalemia, Hyponatremia, LDL Cholesterol, Magnesium, Phosphorus inorganic, and Total Bilirubin, Alanine Amino Transferase, Calcium, Chloride, Cholesterol, Creatine Kinase, Direct Bilirubin, Glucose, High Density Lipid (HDL), Cholesterol direct, Lipase, Potassium, Sodium, Total Cholesterol, Triglycerides, Urea/Blood Urine Nitrogen.|From start of study treatment until the end of treatment visit for each participant, up to Week 264 for Cohort I and up to Week 228 for Cohort II|Safety Population: all participants that took at least one dose of DTG||Participants|||Number
798965|NCT00950859|Secondary|Number of Participants With the Indicated Fold Increase in DTG FC (Fold Change in IC50 Relative to Wild-type Virus) Between Baseline and the Time of PDVF, as a Measure of Post-Baseline Phenotypic Resistance|The FC in IC50 (50% inhibitory concentration) for DTG relative to wild-type virus was determined for virus isolated at Baseline and at the time of PDVF.The number of participants with the indicated change (ratio) in the two values at the time of PDVF is presented. PDVF is defined in relation to Baseline plasma HIV-1 RNA levels: at Day 11, a decrease of <0.7 log 10 c/mL unless <400 c/mL; at Weeks 8 to <16, a decrease of <1.0 log 10 c/mL unless <400 c/mL or an increase of >=1.0 log 10 c/mL from nadir; and at or after Week 16, ≥400 c/mL . PDVF at Day 11 was based on a single plasma HIV-1 RNA evaluation and did not require confirmation. Confirmation testing was required for visits at or after Week 8. For the combination treatment phase, all HIV-1 RNA samples that meet a criterion for suspected PDVF must be confirmed by a second measurement performed at least 1 week but not more than 4 weeks apart from the date of original sample.|From Baseline (Day 1) until study completion (median 605 days for Cohort I, median 1181 days for Cohort II)|PDVF Phenotypic Resistance Populations: all participants in the ITT-E Population with available on-treatment phenotypic resistance data at the time of PDVF failure. Only participants with both Baseline and PDVF time-point DTG phenotypic data were considered for analysis.||Participants|||Number
798966|NCT00950859|Secondary|Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Protocol-defined Virologic Failure (PDVF) as a Measure of Genotypic Resistance|An analysis of changes at specific amino acids in the IN coding region associated with resistance to raltegravir, elvitegravir, or DTG was performed at Day 1 and at the time of PDVF. PDVF is defined in relation to Baseline plasma HIV-1 RNA levels: at Day 11, a decrease of <0.7 log10 c/mL unless <400 c/mL; at Weeks 8 to <16, a decrease of <1.0 log10 c/mL unless <400 c/mL or an increase of >= 1.0 log10 c/mL from nadir; and at or after Week 16, ≥400 c/mL. PDVF at Day 11 was based on a single plasma HIV-1 RNA evaluation and did not require confirmation. Confirmation testing was required for visits at or after Week 8. For the combination treatment phase, all HIV-1 RNA samples that meet a criterion for suspected PDVF must be confirmed by a second measurement performed at least 1 week but not more than 4 weeks apart from the date of the original sample.|From Baseline (Day 1) until study completion (median 605 days for Cohort I, median 1181 days for Cohort II)|On-treatment Genotypic Resistance Population: all ITT-E participants who met the criteria for protocol-defined virological failure (PDVF)||Participants|||Number
798967|NCT00950859|Secondary|Median Fold Change in Sensitivity to DTG by the Baseline (Day 1) IN Mutational Group|Summary of median fold change in sensitivity to DTG by Integrase (IN) mutational group was assessed. The IN mutational group comprises of the following mutations: Q148 +2, Q148 +1, mixture (participants with virus containing more than one Y143, Q148 or N155 mutation at Day 1), Y143, N155, other (participants with virus having no mutations at codons 143, 148, or 155 at Day 1). Fold change (FC) is the fold change in 50% Inhibitory Concentration (IC50) relative to the wild-type control virus.|Baseline (Day 1)|ITT-E Population||Percentage||Full Range|Median
798968|NCT00950859|Secondary|Number of Participants With the Indicated Genotypic Resistance at Baseline|At Baseline, the integrase genotypic results were used to document resistance to raltegravir (RAL) and for the allocation of participants to one of two genotypic groups according to their RAL signature mutations to ensure a broad range of sensitivity to DTG. These results were not used to pre-define subgroup for analysis.|Baseline|ITT-E Population||Participants|||Number
798969|NCT00950859|Secondary|Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion|PDVF is defined in relation to Baseline plasma HIV-1 RNA levels: at Day 11, a decrease of <0.7 log10 c/mL unless <400 c/mL; at Weeks 8 to <16, a decrease of <1.0 log10 c/mL unless <400 c/mL or an increase of >= 1.0 log10 c/mL from nadir; and at or after Week 16, ≥400 c/mL. PDVF at Day 11 was based on a single plasma HIV-1 RNA evaluation and did not require confirmation. Confirmation testing was required for visits at or after Week 8. For the combination treatment phase, all HIV-1 RNA samples that meet a criterion for suspected PDVF must be confirmed by a second measurement performed at least 1 week but not more than 4 weeks apart from the date of the original sample.|Day 11; Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, from Week 108 every 12 weeks up to study completion|ITT-E Population||Participants|||Number
798970|NCT00950859|Secondary|Number of Participants With HIV-1 Associated Disease Progression With the Indicated Shifts to CDC Class C or Death|The number of participants with HIV-1 disease progression (AIDS or death) was assessed per the CDC 1993 revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescents and adults. The CDC classifies HIV infection as Category A (participants with asymptomatic HIV infection, acute HIV infection with accompanying illness, or persistent generalized lymphadenopathy), Category B (participants with symptomatic non-AIDS condition, i.e., conditions that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or conditions are considered by physicians to have a clinical course or to require management that is complicated by HIV infection), and Category C (includes AIDS indicator conditions as defined by diagnostic or presumptive measures).|From the day of the first dose of study drug until study completion (median 605 days for Cohort I, median 1181 days for Cohort II)|ITT-E Population.||Participants|||Number
798971|NCT00950859|Secondary|Number of Participants With the Indicated HIV-1 Associated Conditions, Excluding Recurrences|The number of participants with post-Baseline emergent HIV-1 disease progression (Acquired immunodeficiency syndrome (AIDS) or death) was assessed per the Centers for Disease Control and Prevention (CDC) 1993 revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescents and adults. The CDC classifies HIV infection as Category A (participants with asymptomatic HIV infection, acute HIV infection with accompanying illness, or persistent generalized lymphadenopathy), Category B (participants with symptomatic non-AIDS condition, i.e., conditions that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or conditions are considered by physicians to have a clinical course or to require management that is complicated by HIV infection), and Category C (includes AIDS indicator conditions as defined by diagnostic or presumptive measures).|From the day of the first dose of study drug until study completion (median 605 days for Cohort I, median 1181 days for Cohort II)|ITT-E Population. Participant may have more than one HIV associated condition. Each condition is counted only once per participant, regardless of recurrence.||Participants|||Number
798972|NCT00950859|Secondary|AUC0-24 Assessment of DTG|AUC is defined as the area under the DTG concentration-time curve as a measure of drug exposure. AUC(0-24) is defined as the area under the concentration-time curve from time zero (pre-dose) to 24 hours. AUC0-24 of DTG was assessed at Day 10. Blood samples for pharmacokinetic assessments were collected at pre-dose (within 15 minutes prior to dose) and 2, 3, 4, 8, and 24 hours post-dose on Day 10 for DTG 50 mg OD and pre-dose (within 15 minutes prior to dose) and 2, 3, 4 and 8 hours post morning dose and 12 hours post evening dose for DTG 50 mg BID.|Day 10|PK Parameter Population||Micrograms*hour per milliliter (µg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
798973|NCT00950859|Secondary|Tmax of DTG|The tmax is defined as the time of occurrence of the maximum plasma concentration (Cmax). The tmax was assessed at Day 10. Blood samples for pharmacokinetic assessments were collected at pre-dose (within 15 minutes prior to dose) and 2, 3, 4, 8, and 24 hours post-dose on Day 10 for DTG 50 mg OD and pre-dose (within 15 minutes prior to dose) and 2, 3, 4 and 8 hours post morning dose and 12 hours post evening dose for DTG 50 mg BID.|Day 10|PK Parameter Population||Hours||Full Range|Median
798974|NCT00950859|Secondary|C0 Assessment of DTG|The plasma DTG concentration immediately prior to dosing at steady state (C0) was assessed at Day 10, and Weeks 4 and 24. Blood samples for pharmacokinetic assessments were collected at pre-dose (within 15 minutes prior to dose).|Day 10; Weeks 4 and 24|PK Parameter Population||µg/mL||Geometric Coefficient of Variation|Geometric Mean
798975|NCT00950859|Secondary|Cmax, Cmin, and Ctau of DTG|The maximum plasma concentration (Cmax), minimum plasma concentration (Cmin), and concentration at the end of a dosing interval (Ctau) of DTG were assessed at Day 10. Blood samples for pharmacokinetic (PK) assessments were collected at pre-dose (within 15 minutes prior to dose) and 2, 3, 4, 8, and 24 hours post-dose on Day 10 for DTG 50 mg OD and pre-dose (within 15 minutes prior to dose) and 2, 3, 4 and 8 hours post morning dose and 12 hours post evening dose for DTG 50 mg BID.|Day 10|Pharmacokinetic (PK) Parameter Population: all participants who provided at least one evaluable PK concentration||Micrograms per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
798976|NCT00950859|Secondary|Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion|Change from Baseline in CD4+ cell count was assessed at Day 11 and at Weeks 4, 12, 24, 48, 72, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, and 264 . Study Day 1 was considered as Baseline. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; Day 11; Weeks 4, 12, 24, 48, 72, 96, from Week 108 every 12 weeks up to study completion|ITT-E Population. Only those participants available at the indicated time points were analyzed (represented by n=X in the category titles).||cells per cubic millimeter (mm^3)||Full Range|Median
798977|NCT00950859|Secondary|Proportion of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL From Week 48 Every 12 Weeks up to Study Completion|The number of participants with plasma HIV-1 RNA <400 c/mL or <50 c/mL was assessed at Weeks 48, 72, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, and 264 using data of observed cases. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|From Week 48 every 12 weeks up to study completion|ITT-E Population||Percentage of Participants|||Number
798978|NCT00950859|Secondary|Number of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL at Baseline and Weeks 4, 12, 24, 48, 72, and 96: TLOVR Analysis.|The number of participants with plasma HIV-1 RNA <400 c/mL or <50 c/mL was assessed at Weeks 4, 12, 24, 48, 72, and 96 per the Food and Drug Administration's Time to Loss of Virological Response (TLOVR) algorithm. Using the TLOVR algorithm, participants are considered to have failed on therapy if they never achieved confirmed RNA levels below the threshold, if they had confirmed rebound of RNA above the threshold, if they made a non-permitted change in background regimen, or if they permanently discontinued investigational product for any reason.|Baseline; Weeks 4, 12, 24, 48, 72, and 96|ITT-E Population||Participants|||Number
798979|NCT00950859|Secondary|Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion|Mean change from Baseline in Plasma HIV-1 RNA was assessed on Day 6 to 8, Day 11, and Weeks 4, 12, 24, 48, 72, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, and 264 using data of the observed cases. Study Day 1 was considered as Baseline. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; Day 6 to 8; Day 11; Weeks 4, 12, 24, 48, 72, 96, from 108 every 12 weeks up to study completion|ITT-E Population. Only those participants available at the indicated time points were analyzed (represented by n=X, X in the category titles).||Log10 copies/mL||Standard Deviation|Mean
798980|NCT00950859|Primary|Number of Participants Who Achieved HIV-1 RNA <400 Copies (c)/Milliliter (mL) or at Least 0.7 log10 c/mL Below Their Baseline Value at Day 11|The number of participants who acheived Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) <400 c/mL or at least 0.7 log10 c/mL below their Baseline value at Day 11 was assessed. The last observation was carried forward if a participant had missed the Day 11 visit. The Baseline observation was carried forward if a participant had discontinued the treatment before Day 11. Blood samples for assessment of HIV-1 RNA levels were collected at Baseline and Day 11.|Baseline (Day 1) and Day 11|Intent-to-Treat Exposed (ITT-E) Population: all participants who received at least one dose of study medication and who had at least one post-Baseline measure of plasma HIV-1 RNA.||Participants|||Number
798981|NCT00950872|Secondary|Incidence of Stapler 'Misfires'|The incidence of stapler misfires was captured as the number of patients with misfires. The types of misfires that were captured were less than B shaped staples, incomplete staple line and stripping of the rack teeth.|Day 0|Of the 29 eligible patients, 2 did not have surgery resulting in a total of 27 patients for the analysis.||participants|||Number
798982|NCT00950872|Secondary|Length of Hospital Stay|Days spent in the hospital|Day 2 (Approximately 1.5 days post randomization)|Of the 29 eligible patients, 2 did not have surgery resulting in a total of 27 patients for the analysis.||days||Standard Deviation|Mean
798983|NCT00950872|Secondary|Operating Room (OR) Time|OR time was captured in minutes, with time starting at the first port placement and concluding at the removal of the last port.|Day 0|Of the 29 eligible patients, 2 did not have surgery resulting in a total of 27 patients for the analysis.||minutes||Standard Deviation|Mean
798984|NCT00950872|Primary|Incidence of Adverse Events.||Day 30|Of the 29 eligible patients, 2 did not have surgery resulting in a total of 27 patients for the analysis.||adverse events|||Number
798985|NCT00950911|Primary|Number of Participants Survived||2 years|Full Analysis Set||Participants|||Number
798986|NCT00950937|Secondary|Peak Oxygen Uptake|Is the maximum capacity of an individual's body to transport and utilize oxygen during incremental exercise.|1 time, before the exercise protocol|||ml/min||Standard Deviation|Median
798987|NCT00950937|Secondary|Neutrophil Count|Neutrophil count at three moments: baseline, aerobic and resistance exercise.|3 times - baseline (before the peak oxygen uptake test), aerobic (immediately after aerobic exercise) and resistance (immediately after resistance exercise).|||Cell/ul of blood||Inter-Quartile Range|Median
798988|NCT00950937|Secondary|T CD4|T CD4 lymphocytes counts at three moments: baseline, aerobic and resistance exercise.|3 times - baseline (before the peak oxygen uptake test), aerobic (immediately after aerobic exercise) and resistance (immediately after resistance exercise).|||Cell/ul of blood||Inter-Quartile Range|Median
798989|NCT00950937|Secondary|Lipid Peroxidation|Thiobarbituric acid–reactive substances (TBARS) assay was used as an index of lipid peroxidation in erythrocytes, at three moments: baseline, aerobic and resistance exercise.|3 times - baseline (before the peak oxygen uptake test), aerobic (immediately after aerobic exercise) and resistance (immediately after resistance exercise).|||picomol of TBARS/mg protein||Inter-Quartile Range|Median
798993|NCT00950963|Secondary|Number of Patients With Hgb A1c Less Than 7 Percent at the End of the Study|Number of patients with Hgb A1c as recommended by the American Diabetes Association guidelines.|18 months|||Participants|||Number
798998|NCT00951015|Other Pre-specified|Change From Baseline in Cluster of Differentiation 8+ (CD8+) Cell Counts at the Indicated Time Points|Change from Baseline in CD8+ cell count data are not available; CD8+ data are only listed on a per-participant basis and were not summarized.|Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96|ITT-E Population|||||
798999|NCT00951015|Secondary|Relationship Between Gastrointestinal System Organ Class AEs of Special Interest at Week 96 and the Indicated Plasma DTG PK Parameters|Logistic regressions were performed to examine the correlation between plasma DTG PK parameters (AUC[0-tau] [area under the time concentration curve over the dosing interval], Cmax [maximal concentration], Ctau [concentration at the end of the dosing interval], and C0avg [average pre-dose concentration]) on log scales and the presence of gastrointestinal system organ class AEs (abdominal pain, diarrhea, nausea, and vomiting) at Week 96. Data are presented as estimates from logistic regression, which is a measure of the association between AEs of special interest and plasma DTG PK parameters. A value of 0 indicates no statistical association; a large absolute value of the estimate indicates higher association. Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed. Results are presented for participants in any DTG group (overall DTG).|Week 96|PK/PD Analysis Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the PK/PD Analysis Population.||estimated effect|||Number
799000|NCT00951015|Secondary|Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters|Relationships between log-transformed plasma DTG PK parameters (AUC[0-tau], Cmax, C0, C0avg, Ctau, and Cmin) and safety parameters (AE occurrence, maximum AE intensity, alanine aminotransferase [ALT], change from Baseline [CFB] in ALT, total bilirubin, CFB in total bilirubin, creatine kinase, CFB in creatine kinase, triglycerides, CFB in triglycerides, lipase, CFB in lipase, total cholesterol [TC], CFB in TC) was assessed using Pearson’s correlation analyses. The Pearson's correlation coefficient is a measure of the correlation between safety parameters and plasma DTG PK parameters and ranges from -1 to 1. A value of 0 indicates no statistical association; a value close to -1 or 1 indicates a higher association. The presence of >=1 AE was used for AE occurrence. The most severe AE grade/intensity was used for maximum AE intensity. Maximum laboratory values per participant were used for safety parameters. CFB was calculated as the post-Baseline value minus the value at Baseline.|Week 96|PK/PD Analysis Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the PK/PD Analysis Population.||Pearson's correlation coefficient|||Number
799001|NCT00951015|Secondary|Relationship Between the Change From Baseline in CD4+ Cell Counts at Week 96 and the Indicated Plasma DTG PK Parameters|Relationships between plasma DTG PK parameters (AUC[0-tau] [area under the time concentration curve over the dosing interval], Cmax [maximal concentration], C0avg [average pre-dose concentration], and Ctau [concentration at the end of the dosing interval]) and the change from Baseline in CD4+ cell counts at Week 96 (calculated as the post-Baseline value minus the value at Baseline) was assessed using Pearson’s correlation analyses. The Pearson's correlation coefficient is a measure of the correlation between CD4+ cell counts and plasma DTG PK parameters and ranges from -1 to 1. A value of 0 indicates no statistical association; a value close to -1 or 1 indicates a higher association.Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed.|Week 96|PK/PD Analysis Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the PK/PD Analysis Population.||Pearson's correlation coefficient|||Number
799002|NCT00951015|Secondary|Relationship Between the Change From Baseline in Plasma HIV-1 RNA at Week 2 and the Indicated Plasma DTG PK Parameters|Relationships between Week 2 plasma DTG PK parameters (AUC[0-tau] [area under the time concentration curve over the dosing interval], Cmax [maximal concentration], and Ctau [concentration at the end of the dosing interval]) and the change from Baseline in plasma HIV-1 RNA at Week 2 (calculated as the post-Baseline value minus the value at Baseline) was assessed using Pearson’s correlation analyses. The Pearson's correlation coefficient is a measure of the correlation between plasma HIV-1 RNA and plasma DTG PK parameters and ranges from -1 to 1. A value of 0 indicates no statistical association; a value close to -1 or 1 indicates a higher association. Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed.|Week 2|PK/Pharmacodynamic (PD) Analysis Population: all participants with available PD measures (e.g., safety and/or efficacy data) and with evaluable DTG plasma concentration data considered suitable for investigation of relationship with the PD measures. Only those participants available at the specified time points were analyzed.||Pearson's correlation coefficient|||Number
799003|NCT00951015|Secondary|Time to Maximal Drug Concentration (Tmax) of DTG|tmax of DTG was determined using non-compartmental analysis based on intensive PK sampling at the following time points: pre-dose; 2, 3, 4, 8, and 24 hours post-dose at Week 2. Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed.|pre-dose and 2, 3, 4, 8, and 24 hours post-dose at Week 2|PK Summary Population. Only those participants available at the specified time points were analyzed.||Hours||Full Range|Median
799004|NCT00951015|Secondary|C0 and C0 Avg of DTG|The plasma DTG pre-dose concentration (C0) of DTG was determined using limited/sparse PK sampling at Week 2, Week 12, and Week 24. C0 avg was calculated at Week 24 as the mean of the C0 of DTG at Week 2, Week 12, and Week 24. Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed.|Week 2, Week 12, and Week 24|PK Summary Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Summary Population.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
799045|NCT00951275|Secondary|Percent Change From Baseline to Week 24 in Patient Global Assessment of Pain|The participant’s assessment of their current level of pain was displayed on a 100-millimeter (mm) horizontal visual analog scale (VAS). The left-hand extreme of the line was described as “no pain” and the right-hand as “unbearable pain”. The participant was asked to mark the line that corresponded to their current level of pain; the distance from the left edge was recorded.|Week 24|ITT population||percent change in mm||Standard Deviation|Mean
799005|NCT00951015|Secondary|Cmax, Cmin, and Ctau of DTG|The maximal concentration (Cmax), minimal concentration (Cmax), and concentration at the end of dosing interval (Ctau) of DTG were determined using non-compartmental analysis based on intensive PK sampling at the following time points: pre-dose; 2, 3, 4, 8, and 24 hours post-dose at Week 2. Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed.|pre-dose and 2, 3, 4, 8, and 24 hours post-dose at Week 2|PK Summary Population. Only those participants available at the specified time points were analyzed.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
799006|NCT00951015|Secondary|AUC(0-tau) of DTG|The area under the time concentration curve over the dosing interval (AUC[0-tau]) of DTG was determined using non-compartmental analysis based on intensive PK sampling at the following time points: pre-dose; 2, 3, 4, 8, and 24 hours post-dose at Week 2. Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed.|pre-dose and 2, 3, 4, 8, and 24 hours post-dose at Week 2|PK Summary Population. Only those participants available at the specified time points were analyzed.||Hours*µg/mL||Geometric Coefficient of Variation|Geometric Mean
799007|NCT00951015|Secondary|Plasma DTG Concentration|Blood samples for the determination of plasma DTG concentration were collected from the participants randomized to receive DTG, at the following time points: pre-dose and 2-4 hours post-dose at Weeks 2, Week 12, and Week 24. Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed. The Pharmacokinetic (PK) Summary Population is comprised of all participants who received DTG and underwent intensive PK sampling or limited PK sampling during the study and provided evaluable DTG PK parameters.|Week 2, Week 12, and Week 24|PK Summary Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles).Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Summary Population.||Micrograms per milliliter (µg/mL)||Standard Deviation|Mean
799008|NCT00951015|Secondary|Number of Participants With the Indicated Fold Increase in DTG FC (Fold Change in IC50 Relative to Wild-type Virus) at the Time of PDVF, as a Measure of Post-Baseline Phenotypic Resistance|The FC in IC50 (50% inhibitory concentration) for DTG relative to wild-type virus was determined for virus isolated at Baseline and at the time of PDVF. Fold increase in DTG FC at the time of PDVF was derived as the PDVF FC/Baseline FC ratio. PDVF was defined as (A) Virologic Non-response: a decrease in plasma HIV-1 RNA of <1 log10 copies/mL by Week 4, with subsequent confirmation, unless plasma HIV-1 RNA is <400 copies/mL; confirmed plasma HIV-1 RNA levels >=400 copies/mL on or after Week 24 without evidence of prior suppression to <400copies/mL or (B) Virologic Rebound: confirmed rebound in plasma HIV-1 RNA levels to >=400 copies/mL after prior confirmed suppression to <400 copies/mL; confirmed plasma HIV-1 RNA levels >0.5 log10 copies/mL above the nadir value, where nadir is the lowest HIV-1 value >=400 copies/mL.|From Baseline up to Week 96/Early Withdrawal|On-treatment Phenotypic Resistance Population: all participants in the ITT-E Population with available on-treatment phenotypic data, excluding participants who were not protocol-defined virologic failures.||participants|||Number
799009|NCT00951015|Secondary|Number of Participants With the Indicated Treatment-emergent Major Mutations of Other Classes Detected at the Time of Protocol-defined Virologic Failure (PDVF), as a Measure of Genotypic Resistance|For participants meeting one of the criteria for PDVF, plasma samples collected at the time point of virologic failure were tested to evaluate any potential genotypic and/or phenotypic evolution of resistance. PDVF was defined as (A) Virologic Non-response: a decrease in plasma HIV-1 RNA of <1 log10 copies/mL by Week 4, with subsequent confirmation, unless plasma HIV-1 RNA is <400 copies/mL; confirmed plasma HIV-1 RNA levels >=400 copies/mL on or after Week 24 without evidence of prior suppression to <400copies/mL or (B) Virologic Rebound: confirmed rebound in plasma HIV-1 RNA levels to >=400 copies/mL after prior confirmed suppression to <400 copies/mL; confirmed plasma HIV-1 RNA levels >0.5 log10 copies/mL above the nadir value, where nadir is the lowest HIV-1 value >=400 copies/mL.|From Baseline up to Week 96/Early Withdrawal|On-treatment Genotypic Resistance Population: all participants in the ITT-E Population with available on-treatment genotypic data, excluding participants who were not protocol-defined virologic failures.||participants|||Number
799010|NCT00951015|Secondary|Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Protocol-defined Virologic Failure (PDVF), as a Measure of Genotypic Resistance|For participants meeting one of the criteria for PDVF, plasma samples collected at the time point of virologic failure were tested to evaluate any potential genotypic and/or phenotypic evolution of resistance. PDVF was defined as (A) Virologic Non-response: a decrease in plasma HIV-1 RNA of <1 log10 copies/mL by Week 4, with subsequent confirmation, unless plasma HIV-1 RNA is <400 copies/mL; confirmed plasma HIV-1 RNA levels >=400 copies/mL on or after Week 24 without evidence of prior suppression to <400copies/mL or (B) Virologic Rebound: confirmed rebound in plasma HIV-1 RNA levels to >=400 copies/mL after prior confirmed suppression to <400 copies/mL; confirmed plasma HIV-1 RNA levels >0.5 log10 copies/mL above the nadir value, where nadir is the lowest HIV-1 value >=400 copies/mL.|From Baseline up to Week 96/Early Withdrawal|On-treatment Genotypic Resistance Population: all participants in the ITT-E Population with available on-treatment genotypic data, excluding participants who were not protocol-defined virologic failures.||participants|||Number
799011|NCT00951015|Secondary|Number of Participants With the Indicated Grade 1 to Grade 4 Treatment-emergent Clinical Chemistry and Hematology Toxicities|Blood samples were collected for the measurement of clinical chemistry and hematology parameters. Toxicities were graded for severity according to the Division of AIDS (DAIDS) toxicity scales as: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), or Grade 4 (potentially life threatening).|From Baseline up to Week 96/Early Withdrawal|Safety Population||participants|||Number
799012|NCT00951015|Secondary|Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Events (SAE)|An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity; or is a congenital anomaly/birth defect. All clinically suspected cases of hypersensitivity reaction to abacavir in participants receiving abacavir/lamivudine were reported as SAEs. Medical or scientific judgment was to have been exercised in other situations. Refer to the general AE/SAE module for a list of AEs (occuring at a frequency threshold >=3%) and SAEs.|From Baseline up to Week 96/Early Withdrawal|||participants|||Number
799013|NCT00951015|Secondary|Number of Participants With Plasma HIV-1 RNA <400 c/mL|Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96. The analysis was performed using the time to loss of virological response (TLOVR) dataset. In the TLOVR dataset, participant responses at a specified threshold of HIV-1 RNA (<400 c/mL) are determined by using the Food and Drug Administration's TLOVR algorithm. Using the TLOVR algorithm, participants are considered to have failed on therapy if they never achieved confirmed RNA levels below the threshold, if they had confirmed rebound of RNA above the threshold, if they made a non-permitted change in background regimen, or if they permanently discontinued investigational product for any reason.|Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96|ITT-E Population||participants|||Number
799014|NCT00951015|Secondary|Number of Participants With Plasma HIV-1 RNA <50 c/mL|Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96. The analysis was performed using the time to loss of virological response (TLOVR) dataset. In the TLOVR dataset, participant responses at a specified threshold of HIV-1 RNA (<50 copies/mL) are determined by using the Food and Drug Administration's TLOVR algorithm. Using the TLOVR algorithm, participants are considered to have failed on therapy if they never achieved confirmed RNA levels below the threshold, if they had confirmed rebound of RNA above the threshold, if they made a non-permitted change in background regimen, or if they permanently discontinued investigational product for any reason.|Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96|ITT-E Population||participants|||Number
799015|NCT00951015|Secondary|Number of Participants With the Indicated Type of HIV-1 Disease Progression (AIDS or Death)|Clinical disease progression (CDP) was assessed according to the Centers for Disease Control and Prevention (CDC) HIV-1 classification system. Category (CAT) A: one or more of the following conditions (CON), without any CON listed in Categories B and C: asymptomatic HIV infection, persistent generalized lymphadenopathy, acute (primary) HIV infection with accompanying illness or history of acute HIV infection. CAT B: symptomatic CON that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or that are considered by physicians to have a clinical course or to require management that is complicated by HIV infection; and not included among CON listed in clinical CAT C. CAT C: the clinical CON listed in the AIDS surveillance case definition. Indicators of CDP were defined as: CAT A at Baseline (BS) to CAT B event (EV), CAT A at BS to a CAT C EV; CAT B at BS to a CAT C EV; CAT C at BS to a new CAT C EV; or CAT A, B, or C at BS to death.|From Baseline up to Week 96|ITT-E Population||participants|||Number
799016|NCT00951015|Secondary|Number of Participants With New HIV-associated Conditions of the Indicated Class|HIV-associated conditions were assessed according to the Centers for Disease Control and Prevention (CDC) HIV-1 classification system. Category (CAT) A: one or more of the following conditions (CON), without any CON listed in Categories B and C: asymptomatic HIV infection, persistent generalized lymphadenopathy, acute (primary) HIV infection with accompanying illness or history of acute HIV infection. CAT B: symptomatic CON that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or that are considered by physicians to have a clinical course or to require management that is complicated by HIV infection; and not included among CON listed in clinical CAT C. CAT C: the clinical CON listed in the acquired immunodeficiency syndrome (AIDS) surveillance case definition.|From Baseline up to Week 96|ITT-E Population||participants|||Number
799017|NCT00951015|Secondary|Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at the Indicated Time Points|Blood samples were collected for lymphocyte subset assessment by flow cytometry at Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.|Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96|ITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT-E Population.||Cells per cubic millimeter||Inter-Quartile Range|Median
799018|NCT00951015|Secondary|Change From Baseline in HIV-1 RNA at the Indicated Time Points|Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.|Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96|ITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT-E Population.||log10 c/mL||Standard Deviation|Mean
799019|NCT00951015|Secondary|Viral Change Over the Initial 2 Weeks of Treatment|Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline and Week 2. Viral change is defined as the change in plasma HIV-1 RNA over the initial 2 weeks of treatment, calculated as the value at Week 2 minus the value at Baseline.|Baseline and Week 2|ITT-E Population. Only those participants available at the specified time point were analyzed.||log10 c/mL||Standard Deviation|Mean
799043|NCT00951275|Secondary|Percent Change From Baseline to Week 24 in Investigator's Global Assessment of Disease Activity|The physician’s assessment of the participant's current disease activity was displayed on a 100-mm horizontal VAS. The left-hand extreme of the line was described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme was considered “maximum disease activity”. The physician’s global assessment of disease activity was completed by the Efficacy Assessor who could or could not be a physician. The assessor was asked to mark the line corresponding to their assessment of the participant's present level of disease activity; the distance from the left edge was recorded.|Week 24|ITT population||percent change in mm||Standard Deviation|Mean
800347|NCT00955487|Secondary|Total Ventilation Days|Of those participants who required mechanical ventilation, the total number of days receiving ventilation|After randomization up until hospital discharge|||Days||Standard Deviation|Mean
799020|NCT00951015|Primary|Number of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) at Week 16|Plasma samples were collected for quantitative HIV-1 RNA analysis at Week 16. The analysis was performed using the time to loss of virological response (TLOVR) dataset. In the TLOVR dataset, participant responses at a specified threshold of HIV-1 RNA (<50 copies/mL) are determined by using the Food and Drug Administration's TLOVR algorithm. Using the TLOVR algorithm, participants are considered to have failed on therapy if they never achieved confirmed RNA levels below the threshold, if they had confirmed rebound of RNA above the threshold, if they made a non-permitted change in background regimen, or if they permanently discontinued investigational product for any reason. Data are reported per the Week 16 report. In later cuts of the data, the Week 16 values may have changed (because of the nature of the TLOVR algorithm).|Week 16|Intent-to-Treat Exposed (ITT-E) Population: all randomized participants who received at least one dose of study medication||participants|||Number
799021|NCT00951093|Primary|Number of Participants With Increased Acid Exposure|Increased Acid Exposure occurs when esophageal pH is <4 for a period longer than 4% of the total test time on a 24h pH monitoring.|Before GBP, 6 months after GBP and 39 months after GBP|||participants|||Number
799022|NCT00951093|Primary|Esophageal Acid Exposure at 24h pH Monitoring in Supine Position|Esophageal acid exposure was measured through 24h pH monitoring. Esophageal pH was measured and recorded as the percent of time pH was below 4 while participant in supine position|Before GBP, 6 months after GBP and 39 months after GBP|||percentage of time||Inter-Quartile Range|Median
799023|NCT00951093|Primary|Esophageal Acid Exposure at 24h pH Monitoring in Upright Position|Esophageal acid exposure was measured through 24h pH monitoring. Esophageal pH was measured and recorded as the percent of time pH was below 4 while participant in upright position|Before GBP, 6 months after GBP and 39 months after GBP|||percentage of time||Inter-Quartile Range|Median
799024|NCT00951093|Primary|Total Esophageal Acid Exposure at 24h pH Monitoring|Esophageal acid exposure was measured through 24h pH monitoring. During the entire period, esophageal pH was measured and recorded as the percent of time pH was below 4.|Before GBP, 6 months after GBP and 39 months after GBP|||percentage of time||Inter-Quartile Range|Median
799025|NCT00951093|Primary|Number of Participants With Gastroesophageal Reflux Disease (GERD)|Prevalence of GERD in patients characterized according to troublesome symptomatic syndromes assessed through a validated questionnaire based on the Montreal Consensus.|Before GBP, 6 months after GBP and 39 months after GBP|||participants|||Number
799026|NCT00951093|Primary|Number of Participants With Esophageal Injury|Syndromes with esophageal injury were represented exclusively by the presence of reflux esophagitis|Before GBP, 6 months after GBP and 39 months after GBP|||participants|||Number
799027|NCT00951093|Primary|Number of Participants Presenting Reflux Symptoms|"Prevalence of typical reflux syndrome according to the Montreal Consensus. This Consensus institutes that GERD can be outlined when troublesome symptoms and/or complications induced by reflux of the gastric content back to the esophagus are present.
In order to assess such troublesome symptoms a validated questionnaire translated into Portuguese language was used."|Before GBP, 6 months after GBP and 39 months after GBP|||participants|||Number
799028|NCT00951275|Secondary|Change From Baseline to Weeks 12 and 24 in Efficiency as Assessed by SF-HLQ|Participants were ask to rate their efficiency in working on a scale of of 0 to 10 (0=very worse, 10=as usual). Overall efficiency score was based on the first 6 items of Question 6, which is a descriptive instrument comprised of 7 items designed to evaluate the specific problems affecting production. These 7 items relate to the effect of health problems on concentration, work pace, the need to be alone, making decisions, postponing and transferring work to others. The participant can choose from 4 possible answers: (almost) never, sometimes, often and (nearly) always. Efficiency score range=6 to 24; higher scores indicate higher impairment. Change from baseline was only calculated for participants who completed the questionnaire at all times (baseline, Week 12 and Week 24). A negative change from baseline indicates improvement.|Baseline|ITT population; n=number of participants assessed for the specified parameter.||units on a scale||Standard Deviation|Mean
799029|NCT00951275|Secondary|Efficiency as Assessed by SF-HLQ|Participants were ask to rate their efficiency in working on a scale of of 0 to 10 (0=very worse, 10=as usual). Overall efficiency score was based on the first 6 items of Question 6, which is a descriptive instrument comprised of 7 items designed to evaluate the specific problems affecting production. These 7 items relate to the effect of health problems on concentration, work pace, the need to be alone, making decisions, postponing and transferring work to others. The participant can choose from 4 possible answers: (almost) never, sometimes, often and (nearly) always. Efficiency score range=6 to 24; higher scores indicate higher impairment.|Baseline|ITT population; n=number of participants assessed for the specified parameter.||units on a scale||Standard Deviation|Mean
799030|NCT00951275|Secondary|Change From Baseline to Weeks 12 and 24 SF-HLQ Hindrance Score|"Participants were asked if health problems hindered their paid work on a scale of 1 to 3 (1=no, 2=yes, slightly, 3=yes, very much) and their unpaid work including household work, going shopping, odd jobs, specific activities sharing the household on a scale of 0 to 3 (0=performed without being bothered by healthy problems; 1=performed although bothered by health problems; 2=not performed because of health problems; 3=not performed for reasons other than health problems). Hindrance score is a measure of the hindrance experienced as a result of health problems during the performance of unpaid work. The minimum score per item for hindrance score was 0, maximum score was 2 (Score of 3 was not considered since the reasons were other than health problems). Total score was calculated by adding all 4 items together and ranged from 0 (best possible score) to 8 (worst possible score). A negative change from baseline indicates improvement."|Baseline|ITT population; n=number of participants assessed for the specified parameter.||units on a scale||Standard Deviation|Mean
799044|NCT00951275|Secondary|Percent Change From Baseline to Week 24 in Patient's Global Assessment of Disease Activity|The participant's overall assessment of their current disease activity was displayed on a 100-mm horizontal VAS. The left-hand extreme of the line was described as “no disease activity” (symptom free and no arthritis symptoms) and the right-hand extreme as “maximum disease activity” (maximum arthritis disease activity). Participants were asked to assess their current level of disease activity and mark the line; the distance from the left edge was recorded.|Week 24|ITT population||percent change in mm||Standard Deviation|Mean
800348|NCT00955487|Secondary|Need for Mechanical Ventilation|Number of participants who required endotracheal intubation and mechanical ventilation|Anytime after randomization up to 36 weeks corrected gestational age|||Participants|||Count of Participants
799031|NCT00951275|Secondary|SF-HLQ Hindrance Score|"Participants were asked if their health problems hindered their paid work on a scale of 1 to 3 (1=no, 2=yes, slightly, 3=yes, very much) and their unpaid work including household work, going shopping, odd jobs, specific activities sharing the household on a scale of 0 to 3 (0=performed without being bothered by healthy problems; 1=performed although bothered by health problems; 2=not performed because of health problems; 3=not performed for reasons other than health problems). The total hindrance score for unpaid work was derived by adding up the item scores. This hindrance score is a measure of the hindrance experienced as a result of health problems during the performance of unpaid work. The minimum score per item for hindrance score was 0, maximum score was 2 (Score of 3 was not considered since the reasons were other than health problems). Total score was calculated by adding all 4 items together and ranged from 0 (best possible score) to 8 (worst possible score)."|Baseline|ITT population; n=number of participants assessed for the specified parameter.||units on a scale||Standard Deviation|Mean
799032|NCT00951275|Secondary|Change From Baseline to Weeks 12 and 24 in Number of Hours as Assessed by SF-HLQ|Number of working hours lost, and number of hours of support in in taking over and performing usual household tasks in the last month: chores done by family members, chores done by other persons receiving no pay, home care, other paid care, total number of unpaid hours, and total number of hours during the last month were reported. Changes from baseline were only calculated in participants who completed the questionnaire at all times (baseline, Week 12, and Week 24). Negative number indicates improvement.|Baseline|ITT population; n=number of participants assessed for the specified parameter.||hours||Standard Deviation|Mean
799033|NCT00951275|Secondary|Number of Hours as Assessed by SF-HLQ|Number of working hours lost, and number of hours of support in in taking over and performing usual household tasks in the last month: chores done by family members, chores done by other persons receiving no pay, home care, other paid care, total number of unpaid hours, and total number of hours during the last month were reported.|Baseline|ITT population; n=number of participants assessed for the specified parameter.||hours||Standard Deviation|Mean
799034|NCT00951275|Secondary|Change From Baseline to Weeks 12 and 24 in Number of Days as Assessed by SF-HLQ|The SF-HLQ assessed productivity losses related to health problems in individuals with paid or unpaid work and consists of three modules (absenteeism from paid work, production losses without absenteeism from paid work and hindrance in the performance of paid and unpaid work). Any missed working days or number of worked days with reduced efficiency during the last month were reported.|Weeks 12 and 24|ITT population; n=number of participants assessed for the specified parameter.||days||Standard Deviation|Mean
799035|NCT00951275|Secondary|Number of Days as Assessed by Short Form-Health and Labour Questionnaire (SF-HLQ)|The SF-HLQ assessed productivity losses related to health problems in individuals with paid or unpaid work and consists of three modules (absenteeism from paid work, production losses without absenteeism from paid work and hindrance in the performance of paid and unpaid work). Any missed working days or number of worked days with reduced efficiency during the last month were reported.|Baseline|ITT population; n=number of participants assessed for the specified parameter.||days||Standard Deviation|Mean
799036|NCT00951275|Secondary|Percentage of Participants With an Improvement of ≥1 g/dL in Hemoglobin||Week 24|ITT population||percentage of participants||95% Confidence Interval|Number
799037|NCT00951275|Secondary|Percent Change From Baseline to Week 24 in DAS28 Score|DAS28 calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joints count, the ESR (mm/hr) and patient's global assessment of disease activity (participant rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2=low disease activity, DAS28 >5.1=high disease activity and DAS <2.6=remission.|Week 24|ITT population||percent change from baseline||Standard Deviation|Mean
799038|NCT00951275|Secondary|Percentage of Participants With a Response at Week 24 by DAS28 Category|DAS28 calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joints count, the ESR (mm/hr) and patient's global assessment of disease activity (participant rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2=low disease activity, DAS28 >5.1=high disease activity and DAS <2.6=remission.|Week 24|ITT population||percentage of participants||95% Confidence Interval|Number
799039|NCT00951275|Secondary|Percentage of Participants With a Response at Week 24 by European League Against Rheumatism (EULAR) Category|Disease response was assessed using EULAR Disease Activity Score Based on 28-Joint Count (DAS28) categories of Good, Moderate, or No Response. Good response was defined as a DAS28 score of less than (<)3.2 and improvement from baseline of >1.2; Moderate response was defined as a DAS28 score of 3.2-5.1 and improvement from baseline of 1.2-0.6 or a DAS28 score of >5.1 and improvement from baseline of >1.2; No response was defined as a DAS28 score of >5.1 and improvement from baseline of <1.2. Participants who discontinued prematurely were identified as non-responders.|Week 24|ITT population||percentage of participants||95% Confidence Interval|Number
799040|NCT00951275|Secondary|Percent Change From Baseline to Week 24 in ESR|ESR is a blood test used to monitor therapy in inflammatory diseases such as RA and reflects acute phase reactant levels. ESR is measured in mm per hour (mm/hr); active disease in RA is defined by an ESR greater than 30 mm/hr.|Week 24|ITT population||percent change in mm/hr||Standard Deviation|Mean
799041|NCT00951275|Secondary|Percent Change From Baseline to Week 24 in High-Sensitivity CRP (Hs-CRP)|hs-CRP is an acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA). hsCRP is measured in milligrams per liter (mg/L).|Week 24|ITT population||percent change in mg/L||Standard Deviation|Mean
799042|NCT00951275|Secondary|Percent Change From Baseline to Week 24 in HAQ-DI|HAQ-DI includes 20 questions concerning participant’s activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Overall score was computed as the sum of the domain scores and divided by the number of domains answered. Total possible score range was 0-3 where 0 (equals)=without difficulties; 1= with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all.|Week 24|ITT population||percent change from baseline||Standard Deviation|Mean
799134|NCT00952133|Secondary|Number of Participants Who Experienced no or Reduced Post-Operative Nausea Vomiting (PONV) the First 96 Hours After Surgery|Participants with no or reduced post operative nausea over a 96 hour period after surgery. questionnaires answered after surgery at 2 hour, 6 hour, 12 hour 72 hour and 96 hours post surgery.|Pre-op through 96 hours post-op|||participants|||Number
799046|NCT00951275|Secondary|Percent Change From Baseline to Week 24 in SJC|Sixty-six (66) joints were assessed at each visit for swelling; joints were assessed and classified as swollen/not swollen. Swollen joint count 66 (SJC-66) was calculated as the number of swollen joints from 66 joints; the number of swollen joints was summed (maximum score 66). Calculated values were used for the analysis. A negative score indicated improvement.|Week 24|ITT population||percent change in swollen joints||Standard Deviation|Mean
799047|NCT00951275|Secondary|Percent Change From Baseline to Week 24 in TJC|Sixty-eight (68) joints were assessed at each visit for tenderness; joints were assessed and classified as tender/not tender. Tender joint count 68 (TJC-68) was calculated as the number of tender joints from 68 joints; the number of tender joints was summed (maximum score 68). Calculated values were used for the analysis. A negative score indicated improvement.|Week 24|ITT population||percent change in tender joints||Standard Deviation|Mean
799048|NCT00951275|Primary|Improvement in Fatigue at Week 4 Assessed as Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scores|The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participants fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). Clinically relevant improvement is defined as a greater than or equal to (≥)5-point change from Baseline.|Week 4|ITT population; n=number of participants assessed for the specified parameter at a given visit.||units on a scale||Standard Deviation|Mean
799049|NCT00951275|Secondary|Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Percent (%), 50% or 70% Improvement|The ACR response rates ACR20, ACR50, and ACR70 were defined as ≥20%, ≥50% and ≥ 70% improvement, respectively, in: swollen joint count (SJC) (66 joints) and tender joint count (TJC) (68 joints) and 3 of the 5 remaining ACR parameters: Patient assessment of pain; Patient Global Assessment of Disease Activity; Investigator Global Assessment of Disease Activity; participant self-rated assessment of disability measured by the Health Assessment Questionnaire Disability Index (HAQ-DI); and acute phase response (erythrocyte sedimentation rate [ESR] or C-reactive protein [CRP]).|Week 24|ITT Population||percentage of participants||95% Confidence Interval|Number
799050|NCT00951275|Secondary|Improvement of Fatigue Assessed as Change From Baseline in FACIT-F Scores|The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participants fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). Clinically relevant improvement is defined as a ≥5-point change from Baseline.|Weeks 2, 4, 8, 12, 16, 20 and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.||units on a scale||Standard Deviation|Mean
799051|NCT00951275|Secondary|FACIT-F Scores|The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participants fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). Clinically relevant improvement is defined as a ≥5-point change from Baseline.|Baseline, Weeks 2, 4, 8,12, 16, 20 and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.||units on a scale||Standard Deviation|Mean
799052|NCT00951275|Secondary|Improvement of Anemia Assessed as Change From Baseline in Hemoglobin|Improvement of anemia was evaluated as change in hemoglobin levels from baseline.|Weeks 2, 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.||g/dL||Standard Deviation|Mean
799053|NCT00951275|Primary|Improvement of Anemia at Week 4 Assessed as Change From Baseline in Hemoglobin|Hemoglobin levels were measured as grams/deciliter (g/dL).|Week 4|ITT population||g/dL||Standard Deviation|Mean
799054|NCT00951275|Secondary|Mean Hemoglobin Levels During the Study||Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.||g/dL||Standard Deviation|Mean
799055|NCT00951379|Primary|Dichotomized Clinical Response: Participant Complete or Partial Response Defined as =/>50% Reduction in the Sum of the Measured Products of Perpendicular Dimensions of the Target Lesion(s) or Improvement in the Degree of Dysplasia or Hyperplasia|Clinical Response assessed according to criteria & recorded as Response or No Response, analyzed as dichotomous variable. Complete Response (CR): Disappearance of all evidence of target AND non-target lesions. Partial Response (PR): greater than or equal to 50% reduction in the sum of the products of diameters of all target lesion(s). Non-target lesions may not increase greater than or equal 25% in size and no new lesion may appear. No Change (NC): No change in the size of the lesion(s) and no new lesions appearing, i.e. anything that is not CR, PR or PD. Progressive Disease (PD): Any increase greater than or equal to 25% in the product of the diameters of any measurable lesions or in the estimated size of non-measurable lesions or the appearance of an unequivocal new lesion.|Response assessed at Week 24 ±1 Week|Analysis includes all participants who received at least one dose of treatment. One participant in the Pioglitazone arm never received study drug.||participants|||Number
799094|NCT00951665|Primary|Number of Participants in Phase IIa of the Study Who Received 12 or More Paclitaxel Doses in Combination With T-DM1 and/or Pertuzumab|Participants in Phase IIa received T-DM1 Q3W and paclitaxel in Group A and T-DM1, paclitaxel, and pertuzumab in Group B.|From Day 1 to 15 weeks|Safety Population: All participants of the phase IIa part of the study who received at least a single dose of study medication and did not have disease progression in the first 12 weeks of study treatment were included.||participants|||Number
799056|NCT00951379|Primary|Dichotomized Histologic Response (HR): Participant Complete or Partial Response Defined as =/>50% Reduction in the Sum of the Measured Products of Perpendicular Dimensions of the Target Lesion(s) or Improvement in the Degree of Dysplasia or Hyperplasia|HR according to criteria & recorded as Response or No Response, analyzed as dichotomous variable. CR: Complete reversal dysplasia/hyperplasia to normal epithelium in all biopsied lesions. PR: Improvement of degree dysplasia/hyperplasia in all biopsied lesion from advanced to early, or from early to normal epithelium in some lesions while other biopsied lesions remain stable. No Change (NC): No change in degree dysplasia/hyperplasia in all biopsied lesions, anything not CR, PR or PD. Progressive Disease (PD): Any increase in severity histology grade any biopsied lesion. Early premalignant lesion: lesion defined high risk, indicated by presence of one: hyperplasia at high-risk sites (dorsal, lateral or ventral tongue, or floor of mouth) ONLY, or mild dysplasia. Advanced premalignant lesion: lesion with presence of one: moderate dysplasia or severe dysplasia (excluding CIS), erythroplakia with hyperplasia or of any severity of dysplasia.|Response assessed at Week 24 ±1 Week|All participants who received at least one dose of treatment. One participant in the Pioglitazone arm never received study drug.||participants|||Number
799057|NCT00951379|Secondary|Biomarker Measurements at Scheduled Visits: Tissue Levels of PPARG Nucleus and PPARG Cytoplasm|Tissue levels of Peroxisome proliferator-activated receptor gamma (PPARG) Nucleus and PPARG Cytoplasm as indirect measures of pharmacological effect, PPAR gamma assessed by immunohistochemistry. Tissue levels of biomarkers assessed from the biopsy obtained at the Screening Clinic Visit and Week 24 ± 1 Week, and plasma levels of biomarkers assessed from blood collected at the Baseline Clinic Visit and Week 24 ± 1 Week. Data reported as percentage of cells staining positive, according to nuclear or cytoplasmic compartments.|Baseline to end of study, 24 weeks|Four participants in the Pioglitazone arm were not analyzed at end of study, and two participants in Placebo were not analyzed for PPARG baseline scores. Analysis is based on specimen viability/availability. No exclusions are made for any other reason.||percentage of staining cells positive||Standard Deviation|Mean
799058|NCT00951379|Secondary|Biomarker Measurements at Scheduled Visits: Tissue Levels of B-cell Lymphoma 2 (Bcl2)|Tissue levels of Bcl2 as indirect measures of pharmacological effect assessed by immunohistochemistry (IHC). Tissue levels of biomarkers assessed from the biopsy obtained at the Screening Clinic Visit and Week 24 ± 1 Week, and plasma levels of biomarkers assessed from blood collected at the Baseline Clinic Visit and Week 24 ± 1 Week. Data reported a percentage of cells staining positive, according to nuclear or cytoplasmic compartments.|Baseline to end of study, 24 weeks|Four participants of 25 overall in the Pioglitazone arm were not analyzed for Bcl2 end of study score and one participant in Placebo was not analyzed for Bcl2 baseline score. Analysis is based on specimen viability/availability. No exclusions are made for any other reason.||percentage of staining cells positive||Standard Deviation|Mean
799059|NCT00951379|Secondary|Biomarker Measurements at Scheduled Visits: Tissue Levels of p21|Tissue levels of p21 as indirect measures of pharmacological effect assessed by immunohistochemistry (IHC). Tissue levels of biomarkers assessed from the biopsy obtained at the Screening Clinic Visit and Week 24 ± 1 Week, and plasma levels of biomarkers assessed from blood collected at the Baseline Clinic Visit and Week 24 ± 1 Week. Data reported as percentage of cells staining positive, according to nuclear or cytoplasmic compartments.|Baseline to end of study, 24 weeks|Two participants in the Pioglitazone arm were not analyzed for p21 end of study score. Analysis is based on specimen viability/availability. No exclusions are made for any other reason.||percentage of staining cells positive||Standard Deviation|Mean
799060|NCT00951379|Secondary|Biomarker Measurements at Scheduled Visits: Tissue Levels of Ki-67|Tissue levels of Ki-67 for proliferation assessed by immunohistochemistry (IHC). Tissue levels of biomarkers assessed from the biopsy obtained at the Screening Clinic Visit and Week 24 ± 1 Week, and plasma levels of biomarkers assessed from blood collected at the Baseline Clinic Visit and Week 24 ± 1 Week. Data reported as percentage of cells staining positive, according to nuclear or cytoplasmic compartments.|Baseline to end of study, 24 weeks|Four participants in the Pioglitazone arm were not analyzed for Ki-67 end of study score. Analysis is based on specimen viability/availability. No exclusions are made for any other reason.||percentage of staining cells positive||Standard Deviation|Mean
799061|NCT00951379|Secondary|Biomarker Measurements at Scheduled Visits: Tissue Levels of Cyclin D1|Tissue levels of Cyclin D1 as indirect measures of pharmacological effect assessed by immunohistochemistry (IHC). Tissue levels of biomarkers assessed from the biopsy obtained at the Screening Clinic Visit and Week 24 ± 1 Week, and plasma levels of biomarkers assessed from blood collected at the Baseline Clinic Visit and Week 24 ± 1 Week. Data reported as percentage of cells staining positive, according to nuclear or cytoplasmic compartments.|Baseline to end of study, 24 weeks|Two participants in the Pioglitazone arm were not analyzed for Cyclin D1 end of study score. Analysis is based on specimen viability/availability. No exclusions are made for any other reason.||percentage of staining cells positive||Standard Deviation|Mean
799062|NCT00951379|Secondary|Number of Participants Affected by Adverse Events Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (v4.0)|All adverse events (including serious) and clinical laboratory toxicity summarized affected organ system. Reporting based on the NCI CTCAE v4.0 by treatment, details included in later Adverse Event Module of results.|Up to 26 weeks|Population includes all enrolled participants.||participants|||Number
799063|NCT00951379|Secondary|Number of Participant With Clinical Response by Baseline Characteristics: Alcohol Use|Alcohol use will be summarized by treatment stratified by stage and by group. In addition, the effects of tobacco and alcohol use on the primary endpoint of clinical and pathological response assessed using statistical regression models in an exploratory fashion. Heavy drinkers are participants who drank every day; Light drinkers are participants who drank on some days; Non-drinkers are former drinkers or those who never drank alcohol.|Up to 26 weeks|All participants who received at least one dose of treatment. One participant in the Pioglitazone arm never received study drug.||participants|||Number
799064|NCT00951379|Secondary|Number of Participant With Clinical Response by Baseline Characteristics: Tobacco Use|Tobacco use summarized by treatment stratified by stage and by group. In addition, the effects of tobacco and alcohol use on the primary endpoint of clinical response assessed.|Up to 26 weeks|Analysis includes all participants who received at least one dose of treatment. One participant in the Pioglitazone arm never received study drug.||participants|||Number
800349|NCT00955487|Secondary|Severity of Bronchopulmonary Dysplasia (BPD)|Assessment of the severity of BPD as defined by the oxygen reduction test|36 weeks corrected gestational age|||Participants|||Count of Participants
799065|NCT00951379|Secondary|Number of Participants With Level of C-reactive Protein in Plasma Decrease From >5.0 mg/L to <= 5.0 mg/L From Baseline to End of Study|The longitudinal regression models for analysis of the change in CRP in plasma will be used, with suitable transformation if necessary to satisfy the model assumptions, with treatment, stage and biomarker value at screening visit as covariates.|Baseline to end of study, 24 weeks|Pioglitazone's 26 had 20 evaluable specimens at baseline & 20 at end of study with 2 of those not available for the CRP>5 baseline measure & Placebo's 25 had 25 evaluable at baseline & 21 evaluable at end of study. Analysis based on specimen viability/availability, no exclusions made for other reasons, participants needed 1/+ dose of treatment.||participants|||Number
799066|NCT00951379|Secondary|Number of Participants With >5.0 mg/L in Level of C-reactive Protein in Plasma|"Degree of change of C-reactive protein (CRP) in plasma serum via blood tests.
The longitudinal regression models for analysis of the change in CRP in plasma used, with suitable transformation if necessary to satisfy the model assumptions, with treatment, stage and biomarker value at screening visit as covariates."|Baseline to end of study, 24 weeks|Pioglitazone's 26 had 24 evaluable specimens at baseline & 20 evaluable at end of study with 2 of those not available for CRP>5 baseline measure: Placebo's 25 had 25 evaluable specimens at baseline & 21 at end of study. Analysis based on specimen viability/availability, no exclusions made for other reasons, participant needed 1/+ dose of treatment.||participants|||Number
799067|NCT00951379|Primary|Overall Response <Clinical and Histologic Response Defined as 50% or Greater Reduction in the Sum of the Measured Products of Perpendicular Dimensions of the Target Lesion(s) or Improvement in the Degree of Dysplasia or Hyperplasia>|Overall Dichotomized Clinical and Histologic Response defined as 50% or greater reduction in sum of the measured products of perpendicular dimensions of the target lesion(s) or improvement in the degree of dysplasia or hyperplasia where complete (CR) or partial response (PR) in either clinical or histologic outcome assessed according to criteria given recorded as Response or No Response and analyzed as a dichotomous variable. Clinical Response = CR: Disappearance all evidence target & non-target lesions; PR: >/=50% reduction in sum products of diameters all target lesion(s). Non-target lesions may not increase >/=25% in size & no new lesion. Histologic Response = CR: Complete reversal of dysplasia or hyperplasia to normal epithelium in all biopsied lesions. PR: Improvement of degree of dysplasia or hyperplasia in all biopsied lesion(s) from advanced to early, or from early to normal epithelium in some lesions while other biopsied lesions remain stable.|Response assessed at Week 24 ±1 Week|All participants who received at least one dose of treatment. One participant in the Pioglitazone arm never received study drug.||participants|||Number
799068|NCT00951483|Secondary|Change in 14-item Perceived Stress Scale (PSS-14)|The 14-item Perceived Stress Scale (PSS-14) is a subjective self-report assessment of stress. Each item is rated on a five point frequency scale ranging from 0 = never experiencing the stress symptom to 4 = Very often experiencing the stress symptom. Scores range from 0 to 56, where higher scores indicate higher stress.|Baseline and 12 weeks|This analysis is restricted to the twenty-three individuals from the intervention cohort had valid PSS-14 responses at baseline and 12 weeks; the healthy control arm is not included, because their PSS-14 scores were recorded at baseline only (see baseline characteristics).||units on a scale||Inter-Quartile Range|Median
799069|NCT00951483|Secondary|Change in Beck Depression Inventory (BDI)|The 21-item Beck Depression Inventory (BDI) is a subjective self-report assessment of depression. This version allows scores to range from 0 to 63, where higher scores indicate worsening mood.|Baseline and 12 weeks|This analysis is restricted to the twenty-seven individuals from the intervention cohort had valid BDI responses at baseline and 12 weeks; the healthy control arm is not included, because their BDI scores were recorded at baseline only (see baseline characteristics).||units on a scale||Inter-Quartile Range|Median
799070|NCT00951483|Secondary|Change in Hamilton Rating Scale for Anxiety (HAM-A)|The 14-item Hamilton Rating Scale for Anxiety (HAM-A) is an objective assessment of anxiety administered by a trained rater. This version allows scores to range from 0 to 56, where higher scores indicate worsening anxiety.|Baseline and 12 weeks|This analysis is restricted to the twenty-eight individuals from the intervention cohort had valid HAM-A responses at baseline and 12 weeks; the healthy control arm is not included, because their HAM-A scores were recorded at baseline only (see baseline characteristics).||units on a scale||Inter-Quartile Range|Median
799071|NCT00951483|Secondary|Change in Hamilton Rating Scale for Depression With 21 Items (HAMD-21)|The 21-item Hamilton Rating Scale for Depression (HAMD-21) is an objective assessment of depression administered by a trained rater. This version allows scores to range from 0 to 52, where higher scores indicate worsening mood.|Baseline and 12 weeks|This analysis is restricted to the twenty-eight individuals from the intervention cohort had valid HAM-D-21 responses at baseline and 12 weeks; the healthy control arm is not included, because their HAM-D-21 scores were recorded at baseline only (see baseline characteristics).||units on a scale||Inter-Quartile Range|Median
799072|NCT00951483|Secondary|Change in Hamilton Rating Scale for Depression With 17 Items (HAM-D-17)|The 17-item Hamilton Rating Scale for Depression (HAMD-17) is an objective assessment of depression administered by a trained rater. This version allows scores to range from 0 to 52, where higher scores indicate worsening mood.|Baseline and 12 weeks|This analysis is restricted to the twenty-eight individuals from the intervention cohort who had valid HAM-D-17 responses at baseline and 12 weeks; the healthy control arm is not included, because their HAM-D-17 scores were recorded at baseline only (see baseline characteristics).||units on a scale||Inter-Quartile Range|Median
799073|NCT00951483|Secondary|Change in Hamilton Rating Scale for Depression With Seven Items (HAM-D-7)|The seven item Hamilton Rating Scale for Depression (HAMD-7) is an objective assessment of depression administered by a trained rater. This version allows scores to range from 0 to 22, where higher scores indicate worsening mood.|Baseline and 12 weeks|This analysis is restricted to the twenty-eight individuals from the intervention cohort who had valid HAM-D-7 responses at baseline and 12 weeks; the healthy control arm is not included here, because their HAM-D-7 scores were recorded at baseline only (see baseline characteristics).||units on a scale||Inter-Quartile Range|Median
799074|NCT00951483|Primary|C-Reactive Protein at 12 Weeks|To compare C-Reactive Protein between the treatment and healthy control groups at 12 weeks post treatment.|12 weeks|Due to the cost for the C-reactive protein assay, only 20 individuals from each cohort are analyzed (N = 40).||mg/L||Inter-Quartile Range|Median
799112|NCT00951912|Secondary|Urinary Genistein|Urinary genistein excretion|3 months|The number of participants for analysis was determinted by the number of participants who supplied the urine samples at the 3-month test||ug/ml||Standard Deviation|Geometric Mean
799075|NCT00951509|Primary|Composite Power Mobility Road Test (PMRT) Scores|The computer-based and the virtual environments will be modeled after and scored similarly to the real world PMRT. The PMRT contains two domains: Structured Elements/Tasks and Unstructured Skilled Driving. The first domains contain 16 tasks that include activities such as passing through standard width doorways, and turning a ninety-degree turn, turning 180 degrees. In both domains, each task is scored from 1 to 4, depending on speed and the number of collisions that occur with obstacles. A total score for the entire test is calculated out of a possible 64 points, and the final score on the test reflects the percentage of total points acquired1. A passing score is a percentage of > 95%.|Baseline in-lab testing|Majority of the participants (41%) had a spectrum of multiple disabilities ranging from stroke, spinal stenosis, osteoarthritis, emphysema, and cerebral degeneration, followed by 11 participants (35%) with spinal cord injury.||units on a scale||Standard Error|Mean
799076|NCT00951561|Primary|Percentage of Intervention Uses That Resulted in at Least 1 Point Decrease in Pain and Requiring no Rescue Medication Using the Modified Melzack-McGill Scale Using a Mixed Model|Modified Melzack-McGill Scale measures general pain (0=none, 1-3=mild, 4-6=moderate, 7-9=severe, 10=worst pain) Total Number of Uses Analyzed is a sum of the Number of Uses collected at each time point.|1 month, 2 months, 3 months, 4 months|Statistical analysis was carried out per plan.||percentage of uses|Participants||Number
799077|NCT00951665|Secondary|Progression-free Survival (PFS)|PFS is defined as the time from the first day of study treatment to documented disease progression or death on study i.e., death due to any cause within 30-days of last dose of study treatment, whichever occurs first.|Tumor assessments performed at the end of Cycle 2 and then every 2 cycles (i.e., Cycles 4, 6, 8, 10, etc. [each cycle of 21 days]) throughout the duration of the study (12 months) until disease progression or study discontinuation, whichever occurs first|An efficacy population: All participants who received at least a single dose of study medication were included.||months||Full Range|Median
799078|NCT00951665|Secondary|Percentage of Participants With Clinical Benefit|Clinical benefit is defined as CR, PR, or stable disease (SD) of 6 months or more duration as assessed by the investigator. CR and PR are identified in previous outcome measure. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum longest diameter since the treatment started. PD is defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.|Tumor assessments performed at the end of Cycle 2 and then every 2 cycles (i.e., Cycles 4, 6, 8, 10, etc. [each cycle of 21 days]) throughout the duration of the study (12 months) until disease progression or study discontinuation, whichever occurs first|An efficacy population: All participants who received at least a single dose of study medication were included.||percentage of participants|||Number
799079|NCT00951665|Secondary|Duration of Objective Response|Duration of OR is only calculated for participants with OR and is defined as the time from the first tumor assessment that supports the participant`s OR to disease progression or death.|Tumor assessments performed at the end of Cycle 2 and then every 2 cycles (i.e., Cycles 4, 6, 8, 10, etc. [each cycle of 21 days]) throughout the duration of the study (12 months) until disease progression or study discontinuation, whichever occurs first|An efficacy population: All participants who received at least a single dose of study medication were included. Participants with OR were considered for this outcome measure.||months||95% Confidence Interval|Median
799080|NCT00951665|Secondary|Percentage of Participants With Objective Response Rate (ORR)|Participants with measurable disease (at least one lesion 2 centimeters [cm] or more on computed tomography (CT) scan or 1 cm or more on spiral CT scan) were considered for OR. ORR is defined as the percentage of patients with a complete response (CR)/partial response (PR) determined on two consecutive tumor assessments at least 4 weeks apart based on modified Response Evaluation Criteria in Solid Tumors, Version 1.0 (RECIST). CR defined as disappearance of all target and non-target lesions and normalization of tumor marker level. PR defined as at least 30 percent decrease in sum of the longest diameters of the target lesions taking as reference the baseline sum longest diameters.|Tumor assessments performed at the end of Cycle 2 and then every 2 cycles (i.e., Cycles 4, 6, 8, 10, etc. [each cycle of 21 days]) throughout the duration of the study (12 months) until disease progression or study discontinuation, whichever occurs first|An efficacy population: All participants who received at least a single dose of study medication were included. Participants with measurable disease were considered for OR.||percentage of participants|||Number
799081|NCT00951665|Primary|Number of Participants With Change From Baseline in Cardiac Function|Change in cardiac functions i.e., left ventricular ejection fraction (LVEF) and segmental wall abnormalities were assessed by echocardiogram or multigated acquisition scans. LVEF was assessed as change from baseline as 0 to <15%, >=15 to <25%, >=25%, and missing values.|Baseline (30 days prior to study dose), end of Cycle 2, and then every three cycles in Phase Ib and every four cycles in Phase IIa throughout the duration of the study (12 months) until disease progression or study discontinuation, whichever occurs first|Safety Population: All participants who received at least a single dose of study medication were included.||participants|||Number
799082|NCT00951665|Primary|An Apparent Volume of Distribution at Steady-state (Vss) of Plasma Concentration of Paclitaxel in Cycle 1 (in the Absence of T-DM1) and Cycle 2 (in the Presence of T-DM1)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vss is the apparent volume of distribution at steady-state which is estimated by (D/AUC[0-inf]) X (AUMC[0-inf])/AUC[0-inf]) where D is the dose of study drug, AUMC(0-inf) is the area under the first moment curve extrapolated to infinity and AUC(0-inf) is the area under the plasma concentration-time curve from time zero to infinite time. The Vss of paclitaxel (65 mg/m2 and 80 mg/m2) is observed in Cycle 1 (in the absence of T-DM1) and Cycle 2 (in the presence of T-DM1).|Pre-dose, and 0.25, 1, 2, 4, 6, and 24 hours post-dose for Cycle 1 and Cycle 2|PK population included all participants from Phase Ib who received at least one dose of T-DM1 or paclitaxel with at least one post-dose concentration data point. “n” denotes number of participants who received the indicated study drug.||L/m^2||Standard Deviation|Mean
799113|NCT00951912|Secondary|Urinary Daidzein|Urinary daidzein excretion|3 months|The number of participants for analysis was determinted by the number of participants who provided urine samples at the 3-month test||ug/ml||Standard Deviation|Geometric Mean
805055|NCT01002339|Secondary|Proteinuria||1 year|Participants analyzed: participants living with a functioning graft at study end.||mg/day||95% Confidence Interval|Mean
799083|NCT00951665|Primary|Plasma Clearance (CL) of Concentration of Paclitaxel in Cycle 1 (in the Absence of T-DM1) and Cycle 2 (in the Presence of T-DM1)|Plasma CL of paclitaxel (65 mg/m^2 and 80 mg/m^2) was estimated by non-compartmental analysis for in Cycle 1 (in the absence T-DM1) and Cycle 2 (in the presence T-DM1).|Pre-dose, and 0.25, 1, 2, 4, 6, and 24 hours post-dose for Cycle 1 and Cycle 2|PK population included all participants from Phase Ib who received at least one dose of T-DM1 or paclitaxel with at least one post-dose concentration data point. “n” denotes number of participants who received the indicated study drug.||L/hr/m^2||Standard Deviation|Mean
799084|NCT00951665|Primary|An Elimination Half-life (t1/2) of Plasma Concentration of Paclitaxel in Cycle 1 (in the Absence of T-DM1) and Cycle 2 (in the Presence of T-DM1)|Plasma t1/2 of paclitaxel (65 mg/m^2 and 80 mg/m^2) was estimated by non-compartmental analysis in Cycle 1 (in the absence T-DM1) and Cycle 2 (in the presence T-DM1).|Pre-dose, and 0.25, 1, 2, 4, 6, and 24 hours post-dose for Cycle 1 and Cycle 2|PK population included all participants from Phase Ib who received at least one dose of T-DM1 or paclitaxel with at least one post-dose concentration data point. “n” denotes number of participants who received the indicated study drug.||hr||Standard Deviation|Mean
799085|NCT00951665|Primary|Area Under Plasma Concentration - Time Curve of Paclitaxel From Time 0 to Infinity (AUC0-inf) in Cycle 1 (in the Absence of T-DM1) and Cycle 2 (in the Presence of T-DM1)|Plasma AUC0-inf of paclitaxel (65 mg/m^2 and 80 mg/m^2) was estimated by non-compartmental analysis in Cycle 1 (in the absence T-DM1) and Cycle 2 (in the presence T-DM1).|Pre-dose, and 0.25, 1, 2, 4, 6, and 24 hours post-dose for Cycle 1 and Cycle 2|PK population included all participants from Phase Ib who received at least one dose of T-DM1 or paclitaxel with at least one post-dose concentration data point. “n” denotes number of participants who received the indicated study drug.||hr*ng/mL||Standard Deviation|Mean
799086|NCT00951665|Primary|Maximum Plasma Concentration of Paclitaxel in Cycle 1 (in the Absence T-DM1) and Cycle 2 (in the Presence T-DM1)|Plasma Cmax of paclitaxel (65 mg/m^2 and 80 mg/m^2) for Cycle 1 (in the absence T-DM1) and Cycle 2 (in the presence T-DM1) was estimated by non-compartmental analysis.|Pre-dose, and 0.25, 1, 2, 4, 6, and 24 hours post-dose for Cycle 1 and Cycle 2|PK population included all participants from Phase Ib who received at least one dose of T-DM1 or paclitaxel with at least one post-dose concentration data point. “n” denotes number of participants who received the indicated study drug.||ng/mL||Standard Deviation|Mean
799087|NCT00951665|Primary|Area Under the Serum Concentration-time Curve of Total Exposure (AUClast) of T-DM1 and Total Trastuzumab in Cycle 1 After QW Dose Regimen|AUClast for serum T-DM1 and serum total trastuzumab (sum of conjugated and unconjugated trastuzumab) in Cycle 1 was estimated by non-compartmental analysis for Phase Ib when T-DM1 was administered QW|Pre-dose, and 0.25 and 4 hours post-dose on Day 1; Day 8 (before T-DM1 dose)|PK population included all participants from Phase Ib who received at least one dose of T-DM1 or paclitaxel with at least one post-dose concentration data point. Only participants with data available for this parameter were analyzed.||day*µg/mL||Standard Deviation|Mean
799088|NCT00951665|Primary|Maximum Plasma Concentration (Cmax) of DM1 in Cycle 1 After QW Dose Regimen|Cmax for plasma DM1 in Cycle 1 was estimated by non-compartmental analysis for Phase Ib when T-DM1 was administered QW|Pre-dose, and 0.25 and 4 hours post-dose on Day 1, and Day 8 (before T-DM1 dose)|PK population included all participants from Phase Ib who received at least one dose of T-DM1 or paclitaxel with at least one post-dose concentration data point. Only participants with data available for this parameter were analyzed.||ng/mL||Full Range|Mean
799089|NCT00951665|Primary|Maximum Serum Concentration (Cmax) of T-DM1 and Total Trastuzumab in Cycle 1 After QW Dose Regimen|Cmax for serum T-DM1 and total trastuzumab (sum of conjugated and unconjugated trastuzumab) in Cycle 1 was estimated by non-compartmental analysis when T-DM1 was administered QW.|Pre-dose, and 0.25 and 4 hours post-dose on Day 1; Day 8 (before paclitaxel infusion)|PK population included all participants from Phase Ib who received at least one dose of T-DM1 or paclitaxel with at least one post-dose concentration data point. Only participants with data available for this parameter were analyzed.||mcg/mL||Standard Deviation|Mean
799090|NCT00951665|Primary|Area Under the Serum Concentration-time Curve of Total Exposure (AUC0-Day 21) of T-DM1 and Total Trastuzumab in Cycle 1 After Q3W Dose Regimen|AUC0-21 for serum T-DM1 and total trastuzumab (sum of conjugated and unconjugated trastuzumab) in Cycle 1 was estimated by non-compartmental analysis for Phase Ib when T-DM1 was administered Q3W.|Pre- and post-dose (0.25 and 4 hours and Day 8 [before paclitaxel infusion) for Cycle 1 and pre- and post-dose (0.25 and 4 hours) for Cycle 2 (each cycle of 21 days)|PK population included all participants from Phase Ib who received at least one dose of T-DM1 or paclitaxel with at least one post-dose concentration data point. Only participants with data available for this parameter were analyzed.||day*mcg/mL||Standard Deviation|Mean
799091|NCT00951665|Primary|Maximum Plasma Concentration (Cmax) of DM1 in Cycle 1 After Q3W Dose Regimen|Cmax of plasma DM1 in Cycle 1 was estimated by non-compartmental analysis for Phase Ib when T-DM1 was administered Q3W.|Pre-dose, and 0.25 and 4 hours post-dose on Day 1; Day 8 (before paclitaxel infusion)|PK population included all participants from Phase Ib who received at least one dose of T-DM1 or paclitaxel with at least one post-dose concentration data point. Only participants with data available for this parameter were analyzed.||nano gram per milliliter (ng/mL)||Full Range|Mean
799092|NCT00951665|Primary|Maximum Serum Concentration (Cmax) of T-DM1 and Total Trastuzumab in Cycle 1 After Q3W Dose Regimen|Cmax of serum T-DM1 and total trastuzumab (sum of conjugated and unconjugated trastuzumab) in Cycle 1 was estimated by non-compartmental analysis for Phase Ib when T-DM1 was administered Q3W.|Pre-dose, and 0.25 and 4 hours post-dose on Day 1; Day 8 (before paclitaxel infusion)|Pharmacokinetics (PK) population included all participants from Phase Ib who received at least one dose of T-DM1 or paclitaxel with at least one post-dose concentration data point. Only participants with data available for this parameter were analyzed.||microgram per millilitre (Mcg /mL)||Standard Deviation|Mean
799093|NCT00951665|Primary|Number of Participants Who Had Adverse Events That Required Dose Modification of T-DM1 or Paclitaxel|Participants were assessed for toxicity prior to each dose of T-DM1 and paclitaxel; dosing occurred only if the clinical assessment and laboratory test values were acceptable. Dose modifications included dose delayed or any dose reduction. Participants in whom significant toxicities had not recovered to the treatment range defined by the dose modification guidelines at the time of their next scheduled dose, had their dose of T-DM1 and/or paclitaxel delayed or reduced for up to 21 days.|Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later|Safety Population: All participants who received at least a single dose of study medication were included.||participants|||Number
799095|NCT00951665|Primary|Maximum Tolerated Dose of Paclitaxel When T-DM1 (Q3W or QW) and Paclitaxel (QW) Was Administered With and Without Pertuzumab|The MTD was defined as the highest dose of paclitaxel at which 0 of 3 participants or 1 of 6 experienced a DLT, when paclitaxel (QW) and T-DM1 (Q3W or QW) was administered with and without pertuzumab treatment.|Days 1 to 21|Safety Population: All participants of the dose finding part of the study (phase 1b) who received at least a single dose of study medication were included.||mg/m^2|||Number
799096|NCT00951665|Primary|Maximum Tolerated Dose of T-DM1 When T-DM1 (Q3W or QW) and Paclitaxel (QW) Was Administered With and Without Pertuzumab|The MTD was defined as the highest dose of T-DM1 and paclitaxel at which 0 of 3 participants or 1 of 6 experienced a DLT, when T-DM1 (Q3W or QW) and paclitaxel (QW) was administered with and without pertuzumab treatment.|Days 1 to 21|Safety Population: All participants of the dose finding part of the study (phase 1b) who received at least a single dose of study medication were included.||mg/kg|||Number
799097|NCT00951665|Primary|Number of Participants With Dose Limiting Toxicity (DLT) of the Combination of T-DM1 and Paclitaxel When T-DM1 Was Administered on Either an Q3W or QW Schedule for Both With and Without Pertuzumab Treatment|DLT is defined as one of the following toxicities related to study drug during Cycle 1, according to the NCI CTCAE, Version 3: Grade 3 or higher non-hematologic AEs; Grade 3 or higher elevation of serum bilirubin, hepatic transaminases, or alkaline phosphatase; Grade 4 or higher thrombocytopenia; Grade 4 or higher neutropenia; any subjectively intolerable toxicity related to T-DM1, paclitaxel, or pertuzumab; any treatment-related toxicity prohibiting the start of the second cycle of treatment and/or prompting to a dose delay or modification during the DLT observation period, such as prompting a dose reduction at Cycle 2 Day1.|Up to 23 days|Safety Population: All participants of the dose finding part of the study (phase 1b) who received at least a single dose of study medication were included. Participants in Phase 1b (Regimen 1, Regimen 2, Regimen 3 and Regimen 4 [60 participants]) were considered for this analysis.||participants|||Number
799098|NCT00951665|Primary|Number of Participants With Any Adverse Events (AEs), Serious Adverse Events (SAEs), AEs of Grades 3/4, and Death|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.|Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later|Safety Population: All participants who received at least a single dose of study medication were included.||participants|||Number
799099|NCT00951808|Primary|Acute Chest Syndrome|First occurence of positive infiltrate on chest x-ray|Chest x-rays (CXR) were ordered for trial eligibility, as a result of clinical indications, or at discharge or 72 hours if no prior CXR.|Of 237 enrolled subjects, 27 subjects who received a transfusion and 7 subjects who had insufficient sPLA2 measurements were excluded. Therefore, two hundred and three (203) subjects were included in the analysis. Results were not reported by Arm due to the lack of enrollment.||participants|||Number
799100|NCT00951821|Secondary|Beck Suicide Scale - Adolescent Response|measure of suicidal ideation - scale ranges from 0 to 38 - higher scores indicate higher suicidal ideation. These data refer to adolescent respondents. The outcome is a change score so range is from -38 to 38.|Measured at 12 months|intent to treat||units on a scale||Standard Error|Mean
799101|NCT00951821|Primary|Beck Depression Inventory - Adolescent Report, Change in Symptom Level|self-report measure of depressed mood - range of scores 0 to 60; higher scores indicate worse depression. The data in this outcome refer to change from baseline to 12 month follow-up, per the adolescent self-report.|12 months|intent to treat||change in BDI (-60 to 60 possible range)||Standard Error|Mean
799102|NCT00951899|Secondary|Lipid Values|Lipids are fat-like substances in the blood.|Baseline, 12 weeks|||mmol/l||Standard Error|Mean
799103|NCT00951899|Secondary|Rate of Meal Glucose Disappearance (Meal Rd)|Meal Rd is the rate at which glucose leaves the systemic circulation. It was measured using a triple-tracer mixed meal and reported in micromols over 6 hours. Meal Rd was calculated by subtracting the change in glucose mass from the overall rate of glucose appearance (i.e., meal Ra + EGP).|Baseline, 12 Weeks|||micromol/6h||Standard Error|Mean
799104|NCT00951899|Secondary|Rate of Meal Glucose Appearance (Meal Ra)|Meal Ra was measured using a triple-tracer mixed meal and reported in micromols in 6 hours. Meal derived glucose is a function of both gastric emptying and splanchnic meal extraction. Meal Ra was calculated by multiplying rate of appearance of [1-^13C] glucose (obtained from the infusion rate of [6-^3H] glucose and the clamped plasma ratio of [6-^3H] glucose and [1-^13C] glucose) by the meal enrichment.|Baseline, 12 Weeks|||micromol/6h||Standard Error|Mean
799105|NCT00951899|Secondary|Fasting Endogenous Glucose Production (EGP)|EGP was measured using a triple-tracer mixed meal and calculated using the Steele's model, reported in micromoles per kilogram per minute.|Baseline, 12 Weeks|||micromol/kg/min||Standard Error|Mean
799106|NCT00951899|Secondary|Insulin Concentration|Fasting insulin levels were measured in the plasma using a chemiluminescence assay and is reported in nanomoles over 6 hours.|Baseline, 12 Weeks|||nmols/6 hrs||Standard Error|Mean
799107|NCT00951899|Secondary|Glycosylated Hemoglobin (HbA1c)|HbA1c is the percent of red blood cell hemoglobin with glucose attached to it and an indicator of average blood glucose over the previous two to three months.|Baseline, 12 weeks|||Percentage of hemoglobin||Standard Error|Mean
799108|NCT00951899|Secondary|Plasma Glucose Concentration|Fasting glucose concentrations were measured at baseline and 2 hours post-meal using the glucose oxidase method.|Baseline, 12 Weeks|||mmol/L||Standard Error|Mean
799109|NCT00951899|Secondary|Total Fasting Glucagon-Like Peptide-1 (GLP-1) Concentration|GLP-1 is thought to increase insulin secretion and was measured in the blood and reported in picomoles per liter.|Baseline, 12 weeks|||pmol/L||Standard Error|Mean
799110|NCT00951899|Primary|Total Disposition Index|Total Disposition Index (DI) is a calculated value which represents the ability of a person's pancreas to lower blood glucose. A higher number means the pancreas is better able to lower blood glucose and a lower number means the pancreas is less able to lower blood glucose.|Baseline, 12 weeks|Intent to treat analysis population.||DItot (10^-14 dl/kg/min^2 per pmol/l)||Standard Error|Mean
799111|NCT00951912|Secondary|Total Energy Intake at Follow-up|The energy intake was evaluated by 3 days dietary records.|an average of the 24 weeks follow-up period which were evalutated on baseline,12 week and 24 week.|The number of participants for analysis was determinted by intention to treat||kcal||Standard Deviation|Mean
799119|NCT00951912|Primary|Percentage Change in QUICKI|"QUICKI is the abbreviation of Quantitative Insulin Sensitivity Check Index,and it is a marker to evaluate insulin sensitivity in HOMA model.It is calculated by using the following equation: 1/(logFIns +logFG),where FIns represents fasting insulin in microunits per milliliter, and FG is in millimoles per liter.
The percentage change was caculated as (6th month value-baseline value)/baseline value*100%"|Baseline, 6 months|The number of participants for analysis was determinted by intention to treat||Percentage of change||Standard Deviation|Mean
799120|NCT00951912|Primary|Percentage Change in HOMA-IR|HOMA-IR was calculated with the homeostasis model assessment for insulin resistance,and it is caculated as the following equation: HOMA-IR=FIns×FG/22.5, where FIns represents fasting insulin in microunits per milliliter, and FG is in millimoles per liter. The percentage change was caculated as (6th month value-baseline value)/baseline value*100%|Baseline, 6 months|The number of participants for analysis was determinted by intention to treat||Percentage of change||Standard Deviation|Mean
799121|NCT00951912|Primary|Percentage Change in Fasting Plasma Insulin|(6th month value-baseline value)/baseline value*100%|Baseline, 6 months|The number of participants was determinted by intention to treat||percentage of change||Standard Deviation|Mean
799122|NCT00951912|Primary|Percentage Change in AUC of Glucose|values were from 75g glucose oral glucose tolerance test and caculated as (6th month value-baseline value)/baseline value*100%|Baseline, 6 months|The number of patticipants was determinted by intention to treat||percentage of change||Standard Deviation|Mean
799123|NCT00951912|Primary|Percentage Change in HbA1C|(6th month value-baseline value)/baseline value*100%|Baseline, 6 months|The number of participants analyzed was determinted by intention to treat.||percentage of change||Standard Deviation|Mean
799124|NCT00951912|Primary|Percentage Change in 120-minutes Postload Plasma Glucose|(6th month value-baseline value)/baseline*100%|Baseline, 6 months|All participants were determinted by intention to treat||percentage of change||Standard Deviation|Mean
799125|NCT00951912|Primary|Percentage Change in Fasting Plasma Glucose|(6th month value-baseline value)/baseline value*100%|Baseline,6 months|the number of participants for analysis was determined by intention to treat||percentage of change||Standard Deviation|Mean
799126|NCT00952068|Secondary|Number of Participants With Adverse Events|All adverse events reported during treatment with study drug were considered and reported as treatment emergent adverse events (TEAE) whether or not medication for this adverse event was required by the participant and were summarized in the same table.|6 hours|Safety population: includes all patients who received the dose of the study medication.||participants|||Number
799127|NCT00952068|Secondary|Plasma Levels of Tramadol at 0 Hour (Baseline), Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post-dose|PK samples were drawn at the end of the Screening Phase, at the onset of perceptible pain relief, at 3 hours and at 6 hours post-dose or if the patient discontinues early. PK samples were always drawn after the completion of the patient ratings of pain relief and of pain intensity scales. They were processed in a central laboratory and the plasma levels of tramadol were collected.|Baseline, time of onset of perceptible pain relief, 3 hours post-dose, 6 hours post-dose|Full analysis population: includes all patients who received the dose of study medication and who had at least one pharmacodynamic assessment during the dosing phase.||ng/ml||Standard Deviation|Mean
799128|NCT00952068|Secondary|Patient Rating of Pain Relief at Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post Dose|"Pain relief rating at time of onset of perceptible pain relief, 3 hours and 6 hours post-dose or if the patient discontinued earlier.  How would you rate the pain relief the study medication has given you? ranging from 0=none to 4=complete relief. Missing data were imputed using Last Observation Carried Forward (LOCF)."|3 hours post-dose, 6 hours post-dose, at time of onset of perceptible pain relief|Full analysis population: includes all patients who received the dose of study medication and who had at least one pharmacodynamic assessment during the dosing phase.||participants|||Number
799129|NCT00952068|Secondary|Patient Rating of Pain Intensity at Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post Dose|"Pain intensity rating at baseline, time of onset of perceptible pain relief, 3 hours and 6 hours post-dose or if the patient discontinued earlier. What is your current level of pain intensity? 0=none, 1=mild, 2=moderate, 3=severe. Missing data were imputed using Last Observation Carried Forward (LOCF)."|Baseline, 3 hours post-dose, 6 hours post-dose, time of onset of perceptible pain relief|Full analysis population: includes all patients who received the dose of study medication and who had at least one pharmacodynamic assessment during the dosing phase.||participants|||Number
799130|NCT00952068|Primary|Time to Onset of Perceptible Pain Relief|Kaplan-Meier estimates of time to perceptible pain relief. Patients who discontinued or completed the study without perceptible pain relief were censored at the time point of their last pain intensity score. A confidence interval for the median survival time was calculated.|6 hours|Full analysis population: includes all patients who received the dose of study medication and who had at least one pharmacodynamic assessment during the dosing phase.||minutes||95% Confidence Interval|Median
799131|NCT00952081|Primary|The Primary Endpoint of This Trial is the Proportion of Patients Who Did Not Require Rescue Antihypertensive Medication to Maintain SBP Below 130 mmHg (i.e. Clevidipine is a Sole Antihypertensive Agent Used for Blood Pressure Control)||intraoperatively and 90 min after surgery|||participants|||Number
799132|NCT00952120|Secondary|Percentage of Wounds With Total Skin Graft Loss|For each wound, whether there was total skin graft loss by Day 4 or 5 was determined.|Day 4 or 5|Some patients had multiple wounds that required skin grafting. Wounds were the unit of analysis, so a participant with multiple wounds could be in both treatment groups which is why the total number of participants adds to more than the number of unique participants enrolled in the study (and included in the participant flow and baseline tables)||percentage of wounds|Participants||Number
799133|NCT00952120|Primary|Percentage of Wounds With Complete Skin Graft Take|For each wound, the percentage of the skin graft that took by Day 4 or 5 was calculated. Complete take is defined as 100% take or skin graft incorporation.|Day 4 or 5|Some patients had multiple wounds that required skin grafting. Wounds were the unit of analysis, so a participant with multiple wounds could be in both treatment groups which is why the total number of participants adds to more than the number of unique participants enrolled in the study (and included in the participant flow and baseline tables).||percentage of wounds|Participants||Number
799135|NCT00952133|Primary|Complete Response Rate|A Complete Response (CR): defined as no nausea, no vomiting/retching, no rescue medication and no withdrawal of consent from the time of administration of the study drug(s) until 72 hours post emergence from anesthesia.|Pre-op through 72 hours post emergence from anesthesia|||participants|||Number
799138|NCT00952276|Primary|Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years|Solicited Injections Site Reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering.|Day 0 up to Day 7 post-vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population aged 65 years or older.||Participants|||Number
799139|NCT00952276|Primary|Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years|Solicited Injections Site Reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering|Day 0 up to Day 7 post-vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent to treat population aged 18 to 64 years.||Participants|||Number
799140|NCT00952276|Primary|Geometric Mean Titers (GMTs) of A/H1N1 Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years|Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay.|Day 0 and Day 21 post-vaccination|Pre and post-vaccination antibody titers were assessed in the per-protocol population aged 65 years or older.||Titers||95% Confidence Interval|Geometric Mean
799141|NCT00952276|Primary|Number of Participants With Seroprotection Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years|Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Seroprotection was defined as a titer ≥ 40 (1/dil).|Day 0 and Day 21 post-vaccination|Pre and post-vaccination antibody titers were assessed in the per-protocol population aged 65 years or older.||Participants|||Number
799142|NCT00952276|Primary|Number of Participants With Detectable Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years|Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Detectable anti-HA antibody titer was defined as titers ≥ 10 (1/dil).|Day 0 and Day 21 post-vaccination|Pre and post-vaccination antibody titers were assessed in the per-protocol population aged 65 years or older.||Participants|||Number
799143|NCT00952276|Primary|Geometric Mean Titers (GMTs) of A/H1N1 Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years|Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay.|Day 0 and Day 21 post-vaccination|Pre and post-vaccination antibody titers were assessed in the per-protocol population aged 18 to 64 years.||Titers||95% Confidence Interval|Geometric Mean
799144|NCT00952276|Primary|Number of Participants With Seroprotection Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years|Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Seroprotection was defined as a titer ≥ 40 (1/dil).|Day 0 and Day 21 post-vaccination|Pre and post-vaccination antibody titers were assessed in the per-protocol population aged 18 to 64 years.||Participants|||Number
799145|NCT00952276|Primary|Number of Participants With Detectable Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years|Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Detectable anti HA antibody titer was defined as titers ≥ 10 (1/dilution) on Day 0 and Day 21 post-vaccination.|Day 0 and Day 21 post-vaccination|Pre and post-vaccination antibody titers were assessed in the per-protocol population aged 18 to 64 years.||Participants|||Number
799146|NCT00952289|Secondary|Overall Survival Time at Week 144|Overall survival was assessed by the time to death or censoring. Patients were censored at the time of database cut-off or the later of either the date of withdrawal or the date of last follow-up for patients who withdrew from study before the date of database cut-off. The survival time was analyzed using the Kaplan-Meier method.|Week 144|ITT population||probability||95% Confidence Interval|Number
799147|NCT00952289|Secondary|Overall Survival at Week 144|Overall survival is reported here by the number of deaths from randomization until the data cut-off. Patients were censored at the time of database cut-off or the later of either the date of withdrawal or the date of last follow-up for patients who withdrew from study before the date of database cut-off. The survival time was analyzed using the Kaplan-Meier method.|Week 144|ITT population||participants|||Number
799148|NCT00952289|Secondary|Overall Survival Time - Extended Data|Overall survival was assessed by the time to death or censoring up until 01 March 2011. Patients were censored at this time or the later of either the date of withdrawal or the date of last follow-up for patients who withdrew from study before the date of data cut. The survival time was analyzed using the Kaplan-Meier method. This outcome reports data from August 2009 through March 2011 to coincide with a pre-planned New Drug Application (NDA) 120-day safety update.|From randomization to 4 months after the data cut-off date (up to 18 months).|ITT population||weeks||95% Confidence Interval|Median
799149|NCT00952289|Secondary|Overall Survival - Extended Data|Overall survival is reported here by the number of deaths from randomization until 01 March 2011. Patients were censored at this time or the later of either the date of withdrawal or the date of last follow-up for patients who withdrew from study before the date of data cut. The survival time was analyzed using the Kaplan-Meier method. This outcome reports data from August 2009 through March 2011 to coincide with a pre-planned New Drug Application (NDA) 120-day safety update.|From randomization to 4 months after the data cut-off date (up to 18 months).|ITT population||participants|||Number
799150|NCT00952289|Secondary|Overall Survival Time|Overall survival was assessed by the time to death or censoring. Patients were censored at the time of database cut-off or the later of either the date of withdrawal or the date of last follow-up for patients who withdrew from study before the date of data cut. The survival time was analyzed using the Kaplan-Meier method.|From randomization to the data cut-off date (up to 14 months).|ITT population||weeks||95% Confidence Interval|Median
799151|NCT00952289|Secondary|Overall Survival|Overall survival is reported here by the number of deaths from randomization until the data cut-off. Patients were censored at the time of database cut-off or the later of either the date of withdrawal or the date of last follow-up for patients who withdrew from study before the date of data cut. The survival time was analyzed using the Kaplan-Meier method.|From randomization to the data cut-off date (up to 14 months).|ITT population||participants|||Number
799152|NCT00952289|Secondary|Change From Baseline to Week 24 in Total Symptom Score|Symptoms of myelofibrosis were assessed using a modified Myelofibrosis Symptom Assessment Form (MFSAF) Version 2.0 diary. Using the diary, patients rated the following symptoms on a scale from 0 (absent) to 10 (worst imaginable): night sweats, itching, abdominal discomfort, pain under ribs on left, feeling of fullness (early satiety), and muscle/bone pain. The total symptom score ranged from 0-60 and was calculated as the sum of the 6 symptom scores. A higher score indicates worse symptoms hence a negative change from baseline indicates improvement.|Baseline and Week 24. Baseline total score was the average of the daily total scores for the last 7 days prior to randomization. The Week 24 total score was the average of daily total scores from the 28 days prior to the Week 24 visit.|This analysis only includes patients who had a non-missing change from Baseline to Week 24. Data collected after the date of treatment cross over were not included in this analysis.||scores on a scale||Standard Deviation|Mean
799153|NCT00952289|Secondary|Number of Participants With a ≥ 50% Reduction in Total Symptom Score From Baseline to Week 24|Symptoms of myelofibrosis were assessed using a modified Myelofibrosis Symptom Assessment Form (MFSAF) Version 2.0 diary. Using the diary, patients rated the following symptoms on a scale from 0 (absent) to 10 (worst imaginable): night sweats, itching, abdominal discomfort, pain under ribs on left, feeling of fullness (early satiety), and muscle/bone pain. The total symptom score ranged from 0-60 and was calculated as the sum of the 6 symptom scores. A higher score indicates worse symptoms.|Baseline and Week 24. Baseline total score was the average of the daily total scores for the last 7 days prior to randomization. The Week 24 total score was the average of daily total scores from the 28 days prior to the Week 24 visit.|ITT evaluable population included patients with Baseline data and who did not have a 0 total score at both Baseline & Week 24; data measured after the cross over date were excluded. Patients who withdrew, met cross over criteria prior to Week 24 or had a 0 Baseline score & a nonzero/missing score at Week 24 were considered not meeting the endpoint.||participants|||Number
799154|NCT00952289|Secondary|Duration of Maintenance of a ≥ 35% Reduction From Baseline in Spleen Volume Among Patients Initially Randomized to Receive Ruxolitinib|The duration of ≥ 35% reduction from Baseline in spleen volume was defined as the longest duration of consecutive measurements of ≥ 35% reduction observed before the data cut-off date for patients who had at least one measured ≥ 35% reduction, and who either had at least one subsequent measurement or, who subsequently dropped out prior to another assessment. The duration of a ≥ 35% reduction from Baseline in spleen volume was analyzed using the Kaplan-Meier method.|Baseline Visit and every 12 weeks until the data cut-off date (up to 14 months).|Patients who had at least 1 measurement of ≥ 35% reduction from Baseline in spleen volume at any time during the study and had at least 1 subsequent measurement or withdrew prior to another assessment.||weeks||95% Confidence Interval|Median
799155|NCT00952289|Secondary|Maintenance of a ≥ 35% Reduction From Baseline in Spleen Volume Among Patients Initially Randomized to Receive Ruxolitinib|The maintenance of ≥ 35% reduction from Baseline in spleen volume was assessed up until the data cutoff date using the Kaplan-Meier method for patients who had at least one measured ≥ 35% reduction, and who either had at least one subsequent measurement or who subsequently dropped out prior to another assessment.|Baseline Visit and every 12 weeks until the data cut-off date (up to 14 months).|Patients who had at least 1 measurement of ≥ 35% reduction from Baseline in spleen volume at any time during the study and had at least 1 subsequent measurement or withdrew prior to another assessment.||proportion of participants||95% Confidence Interval|Number
799156|NCT00952289|Primary|Number of Participants Achieving ≥ 35% Reduction in Spleen Volume From Baseline to Week 24|Spleen volume was assessed by magnetic resonance imaging (MRI) or by computed tomography (CT) scans if MRI was not suitable, and analyzed by a blinded central laboratory reader. Patients who withdrew, crossed over to ruxolitinib prior to the visit, or had a missing value at the visit were considered non-responders.|Baseline and Week 24|Intent-to-treat (ITT) population included all subjects randomized in the study. Treatment groups for this population were defined according to the treatment assignment at randomization. One patient was not included in the analysis due to a missing baseline spleen volume value.||participants|||Number
799191|NCT00952484|Secondary|Change in Biomarkers of Asfotase Alfa Activity as Measured by Pyridoxal-5’-Phosphate (PLP)|Change from Baseline to Week 24 in Plasma PLP|Baseline and Week 24|ITT population, which included all randomized patients that received any treatment with asfotase alfa (2 mg/kg or 3 mg/kg thrice weekly), even if they discontinued or were lost to follow-up during the conduct of the clinical trial. Data imputation was not performed.||ng/mL||Standard Deviation|Mean
799165|NCT00952367|Secondary|Risk Factors Associated With Nasopharyngeal Carriage for Moraxella Catarrhalis|Risk factors include birth information (preterm vs full-term birth); household register (local vs nonlocal); mother's education level (illiteracy, elementary school, junior middle school, senior/vocational high school or technical, college/university, vs postgraduate and above); whether have brothers or sisters (no vs yes).|Day 1|PP||relative risk||Standard Error|Mean
799166|NCT00952367|Secondary|Risk Factors Associated With Nasopharyngeal Carriage for Haemophilus Influenzae Type B|Risk factors include birth information (preterm vs full-term birth); household register (local vs nonlocal); feeding manners within 6 months (pure breast feeding, mixed feeding vs pure formula milk feeding); father's education level (illiteracy, elementary school, junior middle school, senior/vocational high school or technical, college/university vs postgraduate and above); living space per capita (continuous variables); vaccination history of Haemophilus influenzae type B (Hib) (no vs yes).|Day 1|PP||relative risk||Standard Error|Mean
799167|NCT00952367|Secondary|Risk Factors Associated With Nasopharyngeal Carriage for Streptococcus Pneumoniae|Risk factors include age of mother bearing (less than or equal to [<=] 30 years versus [vs] more than [>] 30 years); household register (local vs nonlocal); mother's education level (illiteracy, elementary school, junior middle school, senior/vocational high school or technical, college/university vs postgraduate and above); family monthly income per capita (below 600 Chinese Renminbi [RMB], 600 RMB to 1999 RMB, 2000 RMB to 4999 RMB, 5000 RMB to 7999 RMB, 8000 RMB to 9999 RMB vs more than or equal to [>=] 10000 RMB); whether have brothers or sisters (yes vs no).|Day 1|PP||relative risk||Standard Error|Mean
799168|NCT00952367|Secondary|Percentage of Moraxella Catarrhalis Isolates Resistant to Antibiotics|Categories are types of antibiotics.|Day 1|PP. Number of participants analyzed = number of participants with carriage of Moraxella catarrhalis.||percentage of isolates|||Number
799169|NCT00952367|Secondary|Percentage of Haemophilus Influenzae Type B Isolates Resistant to Antibiotics|Categories are types of antibiotics.|Day 1|PP. Number of participants analyzed = number of participants with carriage of Haemophilus influenzae type B.||percentage of isolates|||Number
799170|NCT00952367|Secondary|Percentage of Streptococcus Pneumoniae Isolates Resistant to Antibiotics|Categories are types of antibiotics. Penicillin (Old Criteria): Criteria of non-meningitis Streptococcus pneumoniae isolates resistant to penicillin were changed in Clinical Laboratory and Standards Institute (CLSI) in 2008. Criteria in CLSI before 2008 were the old criteria.|Day 1|PP. Number of participants analyzed = number of participants with carriage of Streptococcus pneumoniae.||percentage of isolates|||Number
799171|NCT00952367|Secondary|Percentage of Participants With Nasopharyngeal Carriage of Moraxella Catarrhalis|A nasopharyngeal swab sample approached via the nasal route was collected. Swab samples were inoculated directly on plates and transferred to local laboratory for culture and isolation of Moraxella catarrhalis. Percentage of participants in whom Moraxella catarrhalis was isolated is reported by site.|Day 1|PP. n=number of participants analyzed at that site.||percentage of participants|||Number
799172|NCT00952367|Secondary|Percentage of Participants With Nasopharyngeal Carriage of Haemophilus Influenzae Type B|A nasopharyngeal swab sample approached via the nasal route was collected. Swab samples were inoculated directly on plates and transferred to local laboratory for culture and isolation of Haemophilus influenzae type B. Percentage of participants in whom Haemophilus influenzae type B was isolated is reported by site.|Day 1|PP. n=number of participants analyzed at that site.||percentage of participants|||Number
799173|NCT00952367|Primary|Percentage of Participants With Serotypes of Streptococcus Pneumoniae|Categories are the serotypes of Streptococcus pneumoniae. NO6A/NO6B belongs to Group 6 but is neither 6A nor 6B. NO23F belongs to Group 23 but is not 23F. NO19A/NO19F belongs to Group 19 but is neither 19A nor 19F. Serotypes G, H, D, I, E, F are results of latex agglutination test, and do not refer to a specific serotype; they cannot be further serotyped by the Quellung reaction. NO(Without capsule) includes all Streptococcus pneumoniae isolates that cannot be serotyped because of no capsule.|Day 1|PP. Number of participants analyzed = number of participants with carriage of Streptococcus pneumoniae isolates.||percentage of participants|||Number
799192|NCT00952484|Secondary|Change in Biomarkers of Asfotase Alfa Activity as Measured by Plasma Inorganic Pyrophosphate (PPi)|Change from Baseline to Week 24 in Plasma PPi|Baseline and Week 24|ITT population, which included all randomized patients that received any treatment with asfotase alfa (2 mg/kg or 3 mg/kg thrice weekly), even if they discontinued or were lost to follow-up during the conduct of the clinical trial. Data imputation was not performed.||uM||Standard Deviation|Mean
799174|NCT00952367|Primary|Percentage of Participants With Nasopharyngeal Carriage of Streptococcus Pneumoniae|A nasopharyngeal swab sample approached via the nasal route was collected. Swab samples were inoculated directly on plates and transferred to local laboratory for culture and isolation of Streptococcus pneumoniae. Percentage of participants in whom Streptococcus pneumoniae was isolated is reported by site.|Day 1|Per-protocol (PP): Participants who completed collection of nasopharyngeal swab sample, Epidemiology Questionnaire, and 24 hours safety observation. n=number of participants analyzed at that site.||percentage of participants|||Number
799175|NCT00952393|Primary|Blood Levels of Drug|This is the plasma level of the drug as determined by high performance liquid chromatography.|12 hours|This is all participants in the study.||ng/ml||Standard Deviation|Mean
799176|NCT00952419|Primary|Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years|Solicited Injection Site Reactions: Pain, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), headache, malaise (feeling unwell), myalgia (muscle aches and pains), shivering.|Days 0 to 7 post vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.||Participants|||Number
799177|NCT00952419|Primary|Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months|Solicited Injection Site Reactions: Pain, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), headache, malaise (feeling unwell), myalgia (muscle aches and pains), shivering.|Days 0 to 7 post-vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.||Participants|||Number
799178|NCT00952419|Primary|Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months|Solicited Injection Site Reactions: Tenderness, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, irritability.|Days 0 to 7 post-vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.||Participants|||Number
799179|NCT00952419|Primary|Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years|Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.|Pre-vaccination (Day 0) and Day 21 post-vaccination|Antibody titers were assessed in the per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
799180|NCT00952419|Primary|Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years|Seroprotection: Antibody titer ≥ 40 1/dil. Antibody titers were determined by the hemagglutination inhibition (HAI) test.|Pre-vaccination (Day 0) and Day 21 post-vaccination|Pre- and post-vaccination antibody titers were assessed in the per-protocol population||Participants|||Number
799181|NCT00952419|Primary|Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years|Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.|Pre-vaccination (Day 0) and 21 days post-vaccination|Pre- and post-vaccination antibody titers were assessed in the per-protocol population||Participants|||Number
799182|NCT00952419|Primary|Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months|Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.|Pre-vaccination (Day 0) and 21 days post-vaccination|Antibody titers were assessed in the per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
799183|NCT00952419|Primary|Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months|Seroprotection: Antibody titer of ≥ 40 1/dil. Antibody titers were determined by the hemagglutination inhibition (HAI) test.|Pre-vaccination (Day 0) and Day 21 post-vaccination|Antibody titers were assessed in the per-protocol population.||Participants|||Number
799184|NCT00952419|Primary|Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months|Pre- and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.|Pre-vaccination (Day 0) and 21 days post-vaccination|Pre- and post-vaccination antibody titers were assessed in the per-protocol population||Participants|||Number
799185|NCT00952484|Secondary|Area Under Serum Concentration-time Curve to Last Measurable Concentration of Asfotase Alfa (AUCt)|Area under serum concentration-time curve to last measurable concentration following multiple doses of asfotase alfa.|Study Week 6 (0 to 48 hours post-dose).|ITT population which included all randomized patients that received any treatment with asfotase alfa (2 mg/kg or 3 mg/kg thrice weekly).||h*U/L||Standard Deviation|Mean
799186|NCT00952484|Secondary|Time at Maximum Serum Concentration of Asfotase Alfa (Tmax).|Time at maximum serum concentration observed following multiple doses of asfotase alfa.|Study Week 6 (0 to 48 hours post-dose)|ITT population which included all randomized patients that received any treatment with asfotase alfa (2 mg/kg or 3 mg/kg thrice weekly).||hours||Standard Deviation|Mean
799187|NCT00952484|Secondary|Maximum Serum Concentration of Asfotase Alfa (Cmax).|Maximum serum concentration observed following multiple doses of asfotase alfa.|Study Week 6 (0 to 48 hours post-dose)|ITT population which included all randomized patients that received any treatment with asfotase alfa (2 mg/kg or 3 mg/kg thrice weekly).||U/L||Standard Deviation|Mean
799188|NCT00952484|Secondary|Area Under Serum Concentration-time Curve to Last Measurable Concentration of Asfotase Alfa (AUCt)|Area under serum concentration-time curve to last measurable concentration following single dose of asfotase alfa.|Study Week 1 (0 to 48 hours post-dose)|ITT population which included all randomized patients that received any treatment with asfotase alfa (2 mg/kg or 3 mg/kg thrice weekly).||h*U/L||Standard Deviation|Mean
799189|NCT00952484|Secondary|Time at Maximum Serum Concentration of Asfotase Alfa (Tmax)|Maximum serum concentration observed following single dose of asfotase alfa.|Study Week 1 (0 to 48 hours post-dose)|ITT population which included all randomized patients that received any treatment with asfotase alfa (2 mg/kg or 3 mg/kg thrice weekly).||hours||Standard Deviation|Mean
799190|NCT00952484|Secondary|Maximum Serum Concentration of Asfotase Alfa (Cmax).|Maximum serum concentration observed following single dose of asfotase alfa.|Study Week 1 (0 to 48 hours post-dose)|ITT population which included all randomized patients that received any treatment with asfotase alfa (2 mg/kg or 3 mg/kg thrice weekly).||U/L||Standard Deviation|Mean
799193|NCT00952484|Secondary|Change in Height (Z-scores)|Change from Baseline to Week 24 in Height Z-Score. Height Z-Scores assigned based on Centers for Disease Control (CDC) growth charts and methodology.|Baseline and Week 24|ITT population, which included all randomized patients that received any treatment with asfotase alfa (2 mg/kg or 3 mg/kg thrice weekly), even if they discontinued or were lost to follow-up during the conduct of the clinical trial. Data imputation was not performed.||Height Z score||Standard Deviation|Mean
799194|NCT00952484|Secondary|Change in Osteomalacia - Mineralization Lag Time (as Measured by Trans-iliac Crest Bone Biopsy)|Change from Baseline to Week 24 in mineralization lag time.|Baseline and Week 24|ITT population, which included all randomized patients that received any treatment with asfotase alfa (2 mg/kg or 3 mg/kg thrice weekly), even if they discontinued or were lost to follow-up during the conduct of the clinical trial. Data imputation was not performed.||days||Standard Deviation|Mean
799195|NCT00952484|Secondary|Change in Osteomalacia - Osteoid Volume/Bone Volume (as Measured by Trans-iliac Crest Bone Biopsy)|Change from Baseline to Week 24 in osteoid volume/bone volume (%), calculated as the absolute difference of the Baseline and Week 24 percentages.|Baseline and Week 24|ITT population, which included all randomized patients that received any treatment with asfotase alfa (2 mg/kg or 3 mg/kg thrice weekly), even if they discontinued or were lost to follow-up during the conduct of the clinical trial. Data imputation was not performed.||percentage points||Standard Deviation|Mean
799196|NCT00952484|Secondary|Change in Osteomalacia - Osteoid Thickness (as Measured by Trans-iliac Crest Bone Biopsy)|Change from Baseline to Week 24 in osteoid thickness.|Baseline and Week 24|ITT population, which included all randomized patients that received any treatment with asfotase alfa (2 mg/kg or 3 mg/kg thrice weekly), even if they discontinued or were lost to follow-up during the conduct of the clinical trial. Data imputation was not performed.||um||Standard Deviation|Mean
799197|NCT00952484|Primary|Change in Rickets Severity on Skeletal Radiographs From Baseline to Week 24 as Measured by the Radiographic Global Impression of Change (RGI-C) Scale|A 7-point RGI-C (radiographic global impression of change) score was used to rate change in rickets severity. Only those patients with a minimum score of +2 indicating substantial healing of rickets) were considered responders. Three pediatric radiologists not affiliated with the conduct of the study performed the ratings.|Baseline and Week 24|ITT population, which included randomized patients that received treatment with asfotase alfa, even if discontinued or lost to follow-up. The last assessment prior to Week 24 is used for missing Week 24 data; patients with no post-baseline assessments imputed as having no change. A historical control group is used for comparison.||units on a scale||Full Range|Median
799198|NCT00952523|Primary|Facial Irritation and Cutaneous Effects|Scores on a scale were recorded each weekday. The scale for Erythema and Dryness was from 0=none to 8=severe (highest possible score is calculated as 8x5daysx3weeks=120). The scale for Burning/Stinging and Itching was from 0=none to 3=severe (highest possible score was calculated as 3x5daysx3weeks=45). The scores that were accumulated through the study for each treatment were then compared.|three weeks|||Scores on a Scale||Standard Deviation|Mean
799199|NCT00952588|Secondary|Percent of Patients With Worsened Functional Assessment of Cancer Therapy – Leukaemia (FACT-Leu) Score.|The total FACT-Leu score consists of 44 items with total scores ranging from 0 to 176. Higher scores indicate better HRQoL. Negative changes from baseline indicate a worsening of HRQoL while positive changes indicate an improvement in HRQoL. A response of “Worsened” was a change from baseline in score of less than or equal to -11.|FACT-Leu was measured every 28 days from randomization for study duration (24 months, between 2009 - 2011)|modified Intent to Treat (mITT)||percentage of participants|||Number
799200|NCT00952588|Secondary|Percent of Patients With Worsened Trial Outcome Index (TOI)|TOI is derived from the sum of the Functional Well Being (FWB), Physical Well Being (PWB) and additional subscales of the FACT-Leu. The TOI subscale consists of 31 items with TOI scores ranging from 0 to 124. The TOI is described as a summary measure of HRQoL. Higher scores indicate better HRQoL. Negative changes from baseline indicate a worsening of HRQoL while positive changes indicate an improvement in HRQoL. A response of “Worsened” was a change from baseline in score of less than or equal to -9.|TOI was measured every 28 days from randomization for study duration (24 months, between 2009 - 2011)|modified Intent to Treat (mITT)||percentage of participants|||Number
799201|NCT00952588|Secondary|Overall Survival (OS)|Overall Survival is defined as the median time from randomisation to death from any cause. Patients who were not known to have died at the time of the analysis were censored at the date they were last known to be alive.|Assessed from randomisation until the date of death from any cause, assessed up to 24 months|modified Intent to Treat (mITT)||months||Full Range|Median
799202|NCT00952588|Secondary|Time To Complete Response (TTCR)|TTCR is measured as time from randomization to either a complete response (CR) or a confirmed complete remission with incomplete recovery of neutrophils or platelets (confirmed CRi)|Response was measured every 28 days from randomization for study duration (24 months, between 2009 - 2011)|modified Intent to Treat (mITT)||days||Inter-Quartile Range|Median
799203|NCT00952588|Secondary|Disease Free Survival (DFS)|Disease-free Survival is defined as the time from randomisation to relapse or death from any cause.|DFS was measured every 28 days from randomization for study duration (24 months, between 2009 - 2011)|modified Intent to Treat (mITT)||months||Inter-Quartile Range|Median
799204|NCT00952588|Secondary|Duration of Response (DoR): Stage I and Transition Phase|DoR was defined for the median of days which showed a confirmed CRi or CR, as the time from first documented evidence of CRi or CR until the first documented sign of disease progression or death. Duration of Response was measured from the Response Start date until evidence of patient relapse or death. Stage I : 45 patients randomized in a 2:1 ratio to AZD1152 or LDAC. Transition phase: enrollment of up to 30 additional patients randomized as per stage I.|DoR was measured every 28 days from randomization for study duration (24 months, between 2009 - 2011)|modified Intent to Treat (mITT)||days||Inter-Quartile Range|Median
799222|NCT00952705|Secondary|The Percentage of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Dose||Days 0-14 post dose|The Evaluable Safety Population for solicited symptoms included all participants who received any investigational product and had any solicited symptom data available during the reporting period.||Percentage of Participants|||Number
799407|NCT00947349|Secondary|CL/F,ss for BI 201335 ZW|apparent clearance of the analyte (BI 201335 ZW) in plasma at steady state (CL/F,ss) following multiple oral administration|10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose|PKS||mL/min||Geometric Coefficient of Variation|Geometric Mean
799205|NCT00952588|Primary|Percentage of Patients With Overall Complete Response for Stage I|Percentage of patients achieving either a complete response (CR) or a confirmed complete remission with incomplete recovery of neutrophils or platelets (confirmed CRi). Per Cheson Criteria: Confirmed complete remission (CRi) is defined as a disappearance of blasts in the peripheral blood; a decrease in bone marrow blasts to <5% total bone marrow nucleated cells demonstrated in bone marrow aspirate; absence of Auer rods; no persistent extramedullary leukaemia. Complete response (CR) is defined as all requirements to meet CRi and in addition: recovery of neutrophils to ≥1.0 x 109/L and platelets to ≥100 x 109/L; transfusion-independence.|IWG Cheson criteria every 28 days from randomization for study duration (24 months, between 2009 - 2011)|modified Intent to Treat (ITT)||percentage of participants|||Number
799206|NCT00952614|Secondary|Improvement in Macular Edema on Optical Coherence Tomography and Color Photos|Anatomic Change in reading of the size of the area of retinal thickening on color photographs and OCT. Total Macular Volume (TMV) in mm^3, is the calculated volume from the layers of the retina based off OCT imaging.|baseline (preoperatively) to 3 years postoperatively|||improvement in TMV/mm^3||Inter-Quartile Range|Mean
799207|NCT00952614|Primary|Change From Baseline in Visual Acuity Using Early Treatment Diabetic Retinopathy Study (ETDRS) Charts|Outcome measure based on eyes at time points with 10-letter ETDRS score improvement|baseline (preoperatively) to 3 years postoperatively|||letters read correctly||Full Range|Mean
799208|NCT00952653|Secondary|1-Hydroxy-Midazolam (Analyte) Terminal Half-life (t 1/2) Following Midazolam Alone and When Coadministered With DVS SR||Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing|PK parameter analysis population; N=number of participants contributing to the mean.||hr||Standard Deviation|Mean
799209|NCT00952653|Secondary|1-Hydroxy-Midazolam (Analyte) Time to Cmax (Tmax) Following Midazolam Alone and When Coadministered With DVS SR||Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing|PK parameter analysis population; N=number of participants contributing to the median.||hr||Full Range|Median
799210|NCT00952653|Secondary|1-Hydroxy-Midazolam (Analyte) Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) Following Midazolam Alone and When Coadministered With DVS SR||Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing|PK parameter analysis population; N=number of participants contributing to the mean.||ng*hr/mL||Standard Deviation|Geometric Mean
799211|NCT00952653|Secondary|Midazolam Terminal Half-life (t 1/2) Following Midazolam Alone and When Coadministered With DVS SR||Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing|PK parameter analysis population; N=number of participants contributing to the mean.||hr||Standard Deviation|Mean
799212|NCT00952653|Secondary|Midazolam Time to Cmax (Tmax) Following Midazolam Alone and When Coadministered With DVS SR||Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing|PK parameter analysis population; N=number of participants contributing to the median.||hr||Full Range|Median
799213|NCT00952653|Secondary|Midazolam Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) Following Midazolam Alone and When Coadministered With DVS SR||Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing|PK parameter analysis population; N=number of participants contributing to the mean.||ng*hr/mL||Standard Deviation|Geometric Mean
799214|NCT00952653|Primary|1-Hydroxy-Midazolam (Analyte) Maximum Observed Plasma Concentration (Cmax) Following Midazolam Alone and When Coadministered With DVS SR||Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing|PK parameter analysis population; N=number of participants contributing to the mean.||ng/mL||Standard Deviation|Geometric Mean
799215|NCT00952653|Primary|1-Hydroxy-Midazolam (Analyte) Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Midazolam Alone and When Coadministered With DVS SR|1-Hydroxy-Midazolam is an analyte of Midazolam.|Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing|PK parameter analysis population; N=number of participants contributing to the mean.||ng*hr/mL||Standard Deviation|Geometric Mean
799216|NCT00952653|Primary|Midazolam Maximum Observed Plasma Concentration (Cmax) Following Midazolam Alone and When Coadministered With DVS SR|Cmax measured as nanograms per milliliters (ng/mL).|Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing|PK parameter analysis population; N=number of participants contributing to the mean.||ng/mL||Standard Deviation|Geometric Mean
799217|NCT00952653|Primary|Midazolam Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Midazolam Alone and When Coadministered With DVS SR|AUCinf measured as nanograms multiplied by hours divided by milliliters (ng*hr/mL).|Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing|PK parameter analysis population: all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. N=number of participants contributing to the mean.||ng*hr/mL||Standard Deviation|Geometric Mean
799218|NCT00952705|Secondary|The Percentage of Participants Reporting New Onset Chronic Diseases From Administration of Investigational Product Through 180 Days Post Dose||Days 0-180 post dose|The Safety Population included participants who received any investigational product and for whom any follow-up safety data were reported.||Percentage of Participants|||Number
799219|NCT00952705|Secondary|The Percentage of Participants Reporting Any Serious Adverse Event From Administration of Investigational Product Through 180 Days Post Dose||Days 0-180 post dose|The Safety Population included participants who received any investigational product and for whom any follow-up safety data were reported.||Percentage of Participants|||Number
799220|NCT00952705|Secondary|The Percentage of Participants Reporting Any Serious Adverse Event From Administration of Investigational Product Through 28 Days Post Dose||Days 0-28 post dose|The Safety Population included participants who received any investigational product and for whom any follow-up safety data were reported.||Percentage of Participants|||Number
799221|NCT00952705|Secondary|The Percentage of Participants Reporting Any Adverse Event From Administration of Investigational Product Through 28 Days Post Dose||Days 0-28 post dose|The Safety Population included participants who received any investigational product and for whom any follow-up safety data were reported.||Percentage of Participants|||Number
799223|NCT00952705|Secondary|The Percentage of Seropositive Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Victoria Strain.|Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain. The comparator for the B/Victoria strain was participants in the FluMist/B/Victoria arm.|Day 28-35|Of 1199 Q/LAIV-treated and 298 FluMist/B/Victoria-treated participants, 815 and 188, respectively, received a full dose of investigational product, had post-dose HAI measurement, were seropositive to B/Victoria, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.||Percentage of Participants|||Number
799224|NCT00952705|Secondary|The Percentage of Seropositive Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Yamagata Strain.|Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain. The comparator for the B/Yamagata strain was participants in the FluMist/B/Yamagata arm.|Day 28-35|Of 1199 Q/LAIV-treated and 300 FluMist/B/Yamagata-treated participants, 986 and 243, respectively, received a full dose of investigational product, had post-dose HAI measurement, were seropositive to B/Yamagata, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.||Percentage of Participants|||Number
799225|NCT00952705|Secondary|The Percentage of Seropositive Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H3N2 Strain.|Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain. The comparator for the A/H3N2 strain was participants in the All FluMist group (combined data for both FluMist arms).|Day 28-35|Of 1199 Q/LAIV-treated and 598 treated participants in the All FluMist group, 430 and 200, respectively, received a full dose of investigational product, had post-dose HAI measurement, were seropositive to A/H3N2, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.||Percentage of participants|||Number
799226|NCT00952705|Secondary|The Percentage of Seropositive Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H1N1 Strain.|Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain. The comparator for the A/H1N1 strain was participants in the All FluMist group (combined data for both FluMist arms).|Day 28-35|Of 1199 Q/LAIV-treated and 598 treated participants in the All FluMist group, 393 and 174, respectively, received a full dose of investigational product, had post-dose HAI measurement, were seropositive to A/H1N1, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.||Percentage of participants|||Number
799227|NCT00952705|Secondary|The Percentage of Serosusceptible Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Victoria Strain.|Participants with a baseline HAI titer ≤ 8 were considered to be serosusceptible for that strain. The comparator for the B/Victoria strain was participants in the FluMist/B/Victoria arm.|Day 28-35|Of 1199 Q/LAIV-treated and 298 FluMist/B/Victoria-treated participants, 361 and 104, respectively, received a full dose of investigational product, had post-dose HAI measurement, were serosusceptible to B/Victoria strain, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.||Percentage of Participants|||Number
799228|NCT00952705|Secondary|The Percentage of Serosusceptible Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Yamagata Strain.|Subjects with a baseline HAI titer ≤ 8 were considered to be serosusceptible for that strain. The comparator for the B/Yamagata strain was participants in the FluMist/B/Yamagata arm.|Day 28-35|Of 1199 Q/LAIV-treated and 300 FluMist/B/Yamagata-treated participants, 189 and 51, respectively, received a full dose of investigational product, had post-dose HAI measurement, were serosusceptible to B/Yamagata strain, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.||Percentage of Participants|||Number
799229|NCT00952705|Secondary|The Percentage of Serosusceptible Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H3N2 Strain.|Participants with a baseline HAI titer ≤ 8 were considered to be serosusceptible for that strain. The comparator for the A/H3N2 strain was participants in the All FluMist group (combined data for both FluMist arms).|Day 28-35|Of 1199 Q/LAIV-treated and 598 treated participants in the All FluMist group, 746 and 386, respectively, received a full dose of investigational product, had post-dose HAI measurement, were serosusceptible to A/H3N2, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.||Percentage of Participants|||Number
799230|NCT00952705|Secondary|The Percentage of Serosusceptible Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H1N1 Strain.|Participants with a baseline HAI titer ≤ 8 were considered to be serosusceptible for that strain. The comparator for the A/H1N1 strain was participants in the All FluMist group (combined data for both FluMist arms).|Day 28-35|Of 1199 Q/LAIV-treated and 598 treated participants in the All FluMist group, 783 and 412, respectively, received a full dose of investigational product, had post-dose HAI measurement, were serosusceptible to A/H1N1, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.||Percentage of participants|||Number
799231|NCT00952705|Secondary|The Percentage of Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Victoria Strain in All Participants, Regardless of Baseline Serostatus.|The comparator for the B/Victoria strain was participants in the FluMist/B/Victoria arm.|Day 28-35|Of 1199 Q/LAIV-treated and 298 FluMist/B/Victoria-treated participants, 1176 and 292, respectively, received a full dose of investigational product, had post-dose HAI measurement for B/Victoria strain, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.||Percentage of Participants|||Number
799232|NCT00952705|Secondary|The Percentage of Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Yamagata Strain in All Participants, Regardless of Baseline Serostatus.|The comparator for the B/Yamagata strain was participants in the FluMist/B/Yamagata arm.|Day 28-35|Of 1199 Q/LAIV-treated and 300 FluMist/B/Yamagata-treated participants, 1176 and 294, respectively, received a full dose of investigational product, had post-dose HAI measurement for B/Yamagata strain, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.||Percentage of subjects|||Number
799408|NCT00947349|Secondary|Cavg for RBV|average plasma concentration (Cavg) of RBV|10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose|PKS||ng/mL||Geometric Coefficient of Variation|Geometric Mean
806021|NCT01008449|Secondary|Operative Procedure Time.|time for procedure as measured in minutes|Intraoperative, at time of intervention.|||minutes||Inter-Quartile Range|Median
799233|NCT00952705|Secondary|The Percentage of Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H1N1 and A/H3N2 Strains in All Participants, Regardless of Baseline Serostatus.|The comparators to the A/H1N1 and A/H3N2 strains were participants in the All FluMist group (combined data for both FluMist arms).|Day 28-35|Of 1199 Q/LAIV-treated and 598 treated participants in the All FluMist group, 1176 and 586, respectively, received a full dose of investigational product, had post-dose HAI measurement for the 2 A strains, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.||Percentage of Participants|||Number
799234|NCT00952705|Secondary|The Percentage of Seropositive Subjects Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Victoria Strain.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain. The comparator for seroresponse to the B/Victoria strain was participants in the FluMist/B/Victoria arm.|Day 0 and Day 28-35|Of 1199 Q/LAIV-treated and 298 FluMist/B/Victoria-treated participants, 815 and 188, respectively, received a full dose of investigational product, had pre- and post-dose HAI measurements, were seropositive to B/Victoria, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.||Percentage of Participants|||Number
799235|NCT00952705|Secondary|The Percentage of Seropositive Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Yamagata Strain.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain. The comparator for seroresponse to the B/Yamagata strain was participants in the FluMist/B/Yamagata arm.|Day 0 and Day 28-35|Of 1199 Q/LAIV-treated and 300 FluMist/B/Yamagata-treated participants, 986 and 243, respectively, received a full dose of investigational product, had pre- and post-dose HAI measurements, were seropositive to B/Yamagata, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.||Percentage of Participants|||Number
799236|NCT00952705|Secondary|The Percentage of Seropositive Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H3N2 Strain.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain. The comparator for seroresponse to the A/H3N2 strain was participants in the All FluMist group (combined data for both FluMist arms).|Day 0 and Day 28-35|Of 1199 Q/LAIV-treated and 598 treated participants in the All FluMist group, 430 and 200, respectively, received a full dose of investigational product, had pre- and post-dose HAI measurements, were seropositive to A/H3N2, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.||Percentage of participants|||Number
799237|NCT00952705|Secondary|The Percentage of Seropositive Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H1N1 Strain.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain. The comparator for seroresponse to the A/H1N1 strain was participants in the All FluMist group (combined data for both FluMist arms).|Day 0 and Day 28-35|Of 1199 Q/LAIV-treated and 598 treated participants in the All FluMist group, 393 and 174, respectively, received a full dose of investigational product, had pre- and post-dose HAI measurements, were seropositive to A/H1N1, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.||Percentage of participants|||Number
799238|NCT00952705|Secondary|The Percentage of Serosusceptible Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Victoria Strain.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer ≤ 8 were considered to be serosusceptible for that strain. The comparator for seroresponse to the B/Victoria strain was participants in the FluMist/B/Victoria arm.|Day 0 and Day 28-35|Of 1199 Q/LAIV-treated and 298 FluMist/B/Victoria-treated participants, 361 and 104, respectively, received a full dose of investigational product, had pre- and post-dose HAI measurements, were serosusceptible to B/Victoria, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.||Percentage of Participants|||Number
799239|NCT00952705|Secondary|The Percentage of Serosusceptible Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Yamagata Strain.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer ≤ 8 were considered to be serosusceptible for that strain. The comparator for seroresponse to the B/Yamagata strain was participants in the FluMist/B/Yamagata arm.|Day 0 and Day 28-35|Of 1199 Q/LAIV-treated and 300 FluMist/B/Yamagata-treated participants, 189 and 51, respectively, received a full dose of investigational product, had pre- and post-dose HAI measurements, were serosusceptible to B/Yamagata, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.||Percentage of Participants|||Number
799240|NCT00952705|Secondary|The Percentage of Serosusceptible Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H3N2 Strain.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer ≤ 8 were considered to be serosusceptible for that strain. The comparator for seroresponse to the A/H3N2 strain was participants in the All FluMist group (combined data for both FluMist arms).|Day 0 and Day 28-35|Of 1199 Q/LAIV-treated and 598 treated participants in the All FluMist group, 746 and 386, respectively, received a full dose of investigational product, had pre- and post-dose HAI measurements, were serosusceptible to A/H3N2, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.||Percentage of Participants|||Number
799241|NCT00952705|Secondary|The Percentage of Serosusceptible Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H1N1 Strain.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer ≤ 8 were considered to be serosusceptible for that strain. The comparator for seroresponse to the A/H1N1 strain was participants in the All FluMist group (combined data for both FluMist arms).|Day 0 and Day 28-35|Of 1199 Q/LAIV-treated and 598 treated participants in the All FluMist group, 783 and 412, respectively, received a full dose of investigational product, had pre- and post-dose HAI measurements, were serosusceptible to A/H1N1, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.||Percentage of participants|||Number
804316|NCT00997438|Primary|Lipoic Acid Levels|Plasma concentration of LA|1 hour|Plasma samples from one secondary progressive and one healthy control subject did not yield results for unknown reason(s).||ng/mL||Standard Error|Mean
799242|NCT00952705|Secondary|The Percentage of Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Victoria Strain in All Participants, Regardless of Baseline Serostatus.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. The comparator for seroresponse to the B/Victoria strain was participants in the FluMist/B/Victoria arm.|Day 0 and Day 28-35|Of 1199 Q/LAIV-treated and 298 FluMist/B/Victoria-treated participants, 1176 and 292 participants, respectively, received a full dose of investigational product, had pre- and post-dose HAI measurements for B/Victoria strain, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.||Percentage of Participants|||Number
799243|NCT00952705|Secondary|The Percentage of Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Yamagata Strain in All Participants, Regardless of Baseline Serostatus.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. The comparator for seroresponse to the B/Yamagata strain was participants in the FluMist/B/Yamagata arm.|Day 0 and Day 28-35|Of 1199 Q/LAIV-treated and 300 FluMist/B/Yamagata-treated participants, 1175 and 294 participants, respectively, received a full dose of investigational product, had pre- and post-dose HAI measurements for B/Yamagata strain, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.||Percentage of Participants|||Number
799244|NCT00952705|Secondary|The Percentage of Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H1N1 and A/H3N2 Strains in All Participants, Regardless of Baseline Serostatus.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. The comparators for seroresponse to the A/H1N1 and A/H3N2 strains were participants in the All FluMist group (combined data for both FluMist arms).|Day 0 and Day 28-35|Of 1199 Q/LAIV-treated and 598 treated participants in the All FluMist group, 1176 and 586 participants, respectively, received a full dose of investigational product, had pre- and post-dose HAI measurements for the 2 A strains, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.||Percentage of Participants|||Number
799245|NCT00952705|Primary|The Post Dose Strain-specific Serum Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMTs) in the Q/LAIV-BFS (MEDI8662) Arm as Compared to Those in the Combined Flumist Arms (All Flumist Group).|Noninferior immune response was assessed by evaluating the upper bound of the 2-sided 95% confidence intervals (CIs) for the ratios of strain-specific HAI GMTs for the specified comparisons. The GMT ratio = GMT in comparator (All FluMist group) divided by the GMT in the Q/LAIV-BFS arm.|Day 28 to 35|Of 1199 Q/LAIV-treated and 598 treated participants in the All FluMist group, 1176 and 586 participants, respectively, received a full dose of investigational product, had a post-dose HAI measurement, and had no protocol violation that could have interfered with generation or interpretation of an immune response.||Geometric Mean Titer||Full Range|Geometric Mean
799246|NCT00952731|Secondary|Difference in Protein S Coagulation Protein in Blood Collected at Baseline and Just Prior to Surgery|The difference between protein S coagulation protein in blood samples collected at baseline and before surgery was measured using an ELISA Kit.|Baseline and immediately before surgery (after approximately 4-10 weeks)|1 patient who did not complete the treatment period due expired drug supply was not evaluable for this outcome measure.||percentage of protein S in blood||Standard Deviation|Mean
799247|NCT00952731|Secondary|Difference in Factor IX Coagulation Protein in Blood Collected at Baseline and Just Prior to Surgery|The difference between Factor IX coagulation protein in blood samples collected at baseline and before surgery was measured with VisuLize antigen ELISA Kits.|Baseline and immediately before surgery (after approximately 4-10 weeks)|1 patient who did not complete the treatment period due expired drug supply was not evaluable for this outcome measure.||percentage of Factor IX protein in blood||Standard Deviation|Mean
799248|NCT00952731|Secondary|Difference in Factor VIII Coagulation Protein in Blood Collected at Baseline and Just Prior to Surgery|The difference between Factor VIII coagulation protein in blood samples collected at baseline and before surgery was measured with VisuLize antigen ELISA Kits.|Baseline and immediately before surgery (after approximately 4-10 weeks)|1 patient who did not complete the treatment period due expired drug supply was not evaluable for this outcome measure.||percentage Factor VIII protein in blood||Standard Deviation|Mean
799249|NCT00952731|Other Pre-specified|E and Z 4-OHT Isomers|Descriptive statistics and confidence intervals will be provided.|28-70 days||||||
799250|NCT00952731|Secondary|Difference in vWF Coagulation Protein in Blood Collected at Baseline and Just Prior to Surgery|The difference between vWF coagulation protein in blood samples collected at baseline and before surgery were measured using the immune-turbidimetric assay.|Baseline to immediately before surgery (after approximately 4-10 weeks)|1 patient who did not complete the treatment period due expired drug supply was not evaluable for this outcome measure.||percentage of vWF protein in blood||Standard Deviation|Mean
799251|NCT00952731|Secondary|Difference in Mean Score for Vasomotor Symptoms Including Hot Flashes From Baseline to Time of Surgery|Hot flashes were assessed by the Breast Cancer Prevention Trial Eight Symptom Scale (BESS) questionnaire. This questionnaire measures the incidence of a number of symptoms by asking participants how frequently they experienced them on a scale of 0-4 (0 being Not at All and 4 being Extremely often). BESS questionnaire was administered at baseline and time of surgery. The incidence of vasomotor symptoms (including hot flashes, night sweats, and cold sweats) was measured at baseline (Day 0) and end of treatment prior to surgery (at least 4 weeks later or up to 10 weeks, depending on scheduled surgery date), and changes in the mean score for hot flashes were observed.|Baseline and after 4-10 weeks of treatment|1 patient who did not complete the treatment period due expired drug supply was not evaluable for this outcome measure.||units on a scale||Standard Deviation|Mean
799252|NCT00952731|Other Pre-specified|TAM Metabolite Concentrations and Estrogen Response Markers in Nipple Aspiration Fluid (NAF)|Descriptive statistics and confidence intervals will be provided.|28-70 days||||||
799253|NCT00952731|Other Pre-specified|4-OHT Affects Known Tamoxifen-modulated Pathways|Descriptive statistics and confidence intervals will be provided.|28-70 days||||||
799254|NCT00952731|Other Pre-specified|Drug Metabolite Levels in the Two Study Groups by CYP2D6 Polymorphism Status|Descriptive statistics and confidence intervals will be provided.|28-70 days||||||
799255|NCT00952731|Other Pre-specified|Compare Concentrations of Tamoxifen and Its Metabolites (4-hydroxytamoxifen, Endoxifen, N-desmethyl Tamoxifen (NDT)) Obtained From Samples on the Day of Surgery|Concentrations of tamoxifen and its metabolites: 4-hydroxytamoxifen, endoxifen, and NDT were measured in breast tissue, blood, and Nipple Aspirate Fluid (NAF) that was collected on the day of surgery.|Day of surgery (after approximately 4-10 weeks)||||||
799256|NCT00952731|Primary|Difference Between Ki-67 Labeling Index in Tissue Samples Taken at Baseline and Post-treatment|Ki-67 was measured in matched core and excision tissue samples containing DCIS (Ductal Carcinoma In-Situ) lesions, the core sample was at baseline while the excision sample was at surgery (after approximately 4-10 weeks of treatment).|Baseline and after 4-10 weeks of treatment|18 total subjects were evaluable for immunohistochemistry marker testing including the Ki-67 labeling index. Of the 26 participants who completed study treatment 2 did not have matching samples available for testing and 6 were excluded because of insufficient DCIS lesion in their samples for testing.||percentage of 300 DCIS cells||Standard Deviation|Mean
799257|NCT00952822|Secondary|Infusion Site Pain|Pain was assessed by participants (≥5 years of age) on a visual analog scale (VAS) from 0 (no pain) to 100 (worst possible pain).|Within 5 minutes post-infusion up to 24 hours post-infusion|Participants who received at least 1 infusion||Scores on a scale||Full Range|Median
799258|NCT00952822|Secondary|Number and Severity of Infusion Site Reactions|Infusion-related local reactions (including pain, tenderness, erythema, induration, and bruising) and severity were evaluated according to an FDA-defined grading scale (FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials; 2007).|Within 5 minutes pre-infusion up to 24 hours post-infusion|Participants who received at least 1 infusion||Participants|||Number
799259|NCT00952822|Secondary|Maximum Plasma Concentration|Maximal factor VIII concentration post-infusion|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Per Protocol||IU/dL||Standard Deviation|Geometric Mean
799260|NCT00952822|Secondary|Volume of Distribution at Steady State|Computed as weight-adjusted clearance * mean residence time|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Per Protocol||dL/kg||Standard Deviation|Mean
799261|NCT00952822|Secondary|Mean Residence Time|Computed as total area under the moment curve divided by the total AUC. Total area under the first moment curve (AUMC) estimated by linear trapezoidal methods|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Per Protocol||hours (h)||Standard Deviation|Mean
799262|NCT00952822|Secondary|Weight-Adjusted Clearance|Computed as the weight-adjusted dose divided by total AUC|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Per Protocol||mL/(kg*h)||Standard Deviation|Mean
799263|NCT00952822|Secondary|Terminal Half-life|Computed from the regression slope in the terminal phase of the model. Terminal half life is the time it takes for the plasma concentration or the amount of drug in the body to be reduced by 50%.|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Per Protocol||hours||Standard Deviation|Mean
799264|NCT00952822|Secondary|Adjusted in Vivo Incremental Recovery|Increase in factor VIII concentration from pre- to post-infusion|Pharmacokinetic evaluations: 30 minutes pre-infusion to 30 minutes post-infusion|Intent to Treat||IU/dL:IU/kg||Standard Deviation|Geometric Mean
799265|NCT00952822|Secondary|Total Area Under the Curve|Total AUC when the concentration is extrapolated to zero using the slope of the β-phase of the model|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Number of complete crossover participants (intent to treat) who received the assigned sequence of 2 infusions: reconstituted in 2mL then 5mL SWFI or in 5mL then 2mL SWFI.||IU*h/dL||Standard Deviation|Geometric Mean
799266|NCT00952822|Primary|Area Under the Curve|Area under the factor VIII (FVIII) plasma concentration versus time curve (AUC) from 0 to 48 hours estimated using the linear trapezoidal method|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Number of complete crossover participants (per protocol) who received the assigned sequence of 2 infusions: reconstituted in 2mL then 5mL SWFI or in 5mL then 2mL SWFI.||IU*h/dL||Standard Deviation|Geometric Mean
799267|NCT00952848|Secondary|Toxicity of MC5-A Therapy on Global Quality of Life Using the Uniscale Instrument|Change on global quality of life. The global quality of life will improve as measured by the Uniscale Linear Analog Scale Assessment (LASA) quality of life scale 0=as bad as it can be to 10=as good as it can be. Scores will be averaged.|2 weeks|Patients treated with MC5A devise for 10 consectuvive days||units on a scale||90% Confidence Interval|Median
799268|NCT00952848|Secondary|Effect of MC5-A on Morphine Oral Equivalent Doses Used Before and After MC5-A Therapy|The change in overal equivalent doses (all narcotic doses will be converted to morphine oral equivalent doses ie as mg/24hours. (All opiates taken will be recorded for the full 24 hours preceding the visit or phone call. All opiates will be converted to the pnmorphine equivalent using the Morphine oral dose equivalents (MOED). The total MOEDs taken during the 24 hours will be the sum of all opiates taken) used before intervention|2 weeks|Patients treated with MC5A devise for 10 consectuvive days||mg/24hr||90% Confidence Interval|Median
799269|NCT00952848|Secondary|Effect of MC5-A on Pain and Neuropathy|Change on pain and neuropathy as measured by the Eastern Cooperative Oncology Group (ECOG) Common Toxicity Criteria for Sensory Neuropathy scale,0=none to 4=paralysis; the World Health Organization (WHO) Classification Scale, 0=none to 4=paralysis; and the Brief Pain Inventory-Short Form, 0=none to 4=most intense pain imaginable. Scores will be averaged.|2 weeks|Patients treated with MC5A devise for 10 consectuvive days||units on a scale||90% Confidence Interval|Median
799270|NCT00952848|Primary|Change in Pain Score|"Change in Neumeric Rating Score for Pain as measured by a Numeric Pain Rating scale between day 0 to day 15.
Scale is 0 (none) to 10 (severe)"|15 days|Patients treated with MC5A devise for 10 consectuvive days||units on a scale||90% Confidence Interval|Median
799271|NCT00953017|Secondary|Polyps Detected|Number of polyps|measured at the time of colonoscopy|||polyps|||Number
799272|NCT00953017|Secondary|Procedure Time|total colonoscopy procedure time|measured at the time of colonoscopy|||minutes||Standard Deviation|Mean
799273|NCT00953017|Secondary|Patient Satisfaction With the Prep Measured by 5 Point Likert Scale|patient satisfaction based on a Likert Scale from 0-5 (5 being completely satisfied and 0 being not satisfied)|measured at check in to colonoscopy|||units on a scale||Standard Deviation|Mean
799298|NCT00953147|Secondary|Change From Baseline in Daily Subject-reported AM rNSS Averaged Over the First 6 Weeks of the Double-blind Treatment|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0 - 6|Intent to Treat Population. Not all subjects analyzed due to missing data.||units on a scale||Standard Error|Least Squares Mean
799274|NCT00953017|Primary|The Cleanliness of the Prep as Measured by the Ottawa Scale|Bowel cleansing was evaluated with the Ottawa bowel preparation scale by each endoscopist during the endoscopy. Neither the endoscopist nor the endoscopy nurse was aware of the bowel preparation used prior to the colonoscopy. The Ottawa bowel preparation scale is a validated tool and was used in this study to provide a reliable quality assessment of the bowel preparation used for colonoscopy. This validated scale rates each section of the colon, the right, the mid, and the rectosigmoid colon, on a 5-point scale (0-4), as well as a global 3-point rating for overall colonic fluid (0-2). The total score ranges from 0 to 14. An excellent preparation with little fluid would score 0-3, a good preparation 4-6, while scores higher than 7 would indicate progressively worsening bowel preparations. A completely unprepared colon would score 11-14, depending on the amount of colonic fluid.|measured at the time of colonoscopy|||Ottawa Scale||Full Range|Mean
799275|NCT00953043|Secondary|Median Pressure When Pain Sensation Was First Reported by 50% of Participants|The sensory threshold for first perception of pain was measured by stepwise inflation in increments of 4 mm Hg at 60 second intervals up to a maximum pressure of 64 mmg Hg. During this assessment participants were asked to report when they had the first perception of pain. The investigator recorded the threshold pressure at which the participants reported this sensation.|approximately 45 min after colonic tube placement, on Day 3|||mm Hg||Full Range|Median
799276|NCT00953043|Secondary|Median Pressure When Gas Sensation Was First Reported by 50% of Participants|The sensory threshold for first perception of gas was measured by stepwise inflation in increments of 4 mm Hg at 60 second intervals up to a maximum pressure of 64 mmg Hg. During this assessment participants were asked to report when they had the first perception of gas. The investigator recorded the threshold pressure at which the participants reported this sensation.|approximately 45 min after colonic tube placement, on Day 3|||mm Hg||Full Range|Median
799277|NCT00953043|Secondary|Median Pressure When First Sensation Was Reported by 50% of Participants|The sensory threshold for first sensation was measured by stepwise inflation in increments of 4 mm Hg at 60 second intervals up to a maximum pressure of 64 mmg Hg. During this assessment participants were asked to report when they had the first sensation. The investigator recorded the threshold pressure at which the participants reported this sensation.|approximately 45 min after colonic tube placement, on Day 3|||mm Hg||Full Range|Median
799278|NCT00953043|Secondary|Gas Sensation Ratings in Response to Colonic Distensions at 32 mm Hg Above Baseline Operating Pressure|Gas sensation was measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes of 0 for no gas sensation and 100 mm for extreme gas sensation. The investigator measures the mark made by the participant in mm and records this for the value of gas sensation.|approximately 1 hour after colonic tube placement, on Day 3|||mm||Standard Error|Mean
799279|NCT00953043|Primary|Pain Sensation Ratings in Response to Colonic Distension at 32 mm HG Above Baseline Operating Pressure|Pain was measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes of 0 for no pain and 100 mm for extreme pain. The investigator measures the mark made by the participant in mm and records this for the value of pain.|approximately 1 hour after colonic tube placement, on Day 3|||mm||Standard Error|Mean
799280|NCT00953043|Primary|Postprandial Colonic Tone|Colonic tone was assessed by noting the changes in the balloon volume in the presence of a constant operating pressure in the balloon (in the barostat-manometric assembly placed in the colon).|30 minutes after standard meal, on Day 3|||mL||Standard Error|Mean
799281|NCT00953043|Primary|Fasting Colonic Tone|Colonic tone is a measurement of the volume of the colon. Colonic tone was assessed by noting the changes in the balloon volume in the presence of a constant operating pressure in the balloon (in the barostat-manometric assembly placed in the colon).|30 minutes after the colonic tube placement, on Day 3|||mL||Standard Error|Mean
799282|NCT00953043|Primary|Colonic Compliance|"Colonic compliance is a measure of the stiffness of the colon, that is, what pressure was needed to reach half the maximum volume of the colon.
After the barostat catheter was inserted in the colon, the catheter was connected to a barostat machine. After an initial conditioning distension to 20 mm Hg, colonic compliance was measured by step-wise inflation with increments of 4 mm Hg up to 64 mm Hg. Colonic compliance was analyzed by a validated linear interpolation method. The pressure at half maximum volume serves as a summary of colonic compliance."|1 hour after third dose of lubiprostone or placebo, on Day 3|||mm Hg||Standard Error|Mean
799283|NCT00953056|Secondary|Number of Infants With Fecal Vaccine Virus Shedding|Fecal shedding of vaccine rotavirus in Cohort III (infants) was evaluated by determining the number of participants whose stool was positive by both (1) the Enzyme-linked Immunosorbent Assay (EIA) to detect the rotavirus antigen, and (2) PCR VP6 Genotyping (a polymerase chain reaction assay specific for rotavirus genome 6, coding for the VP6 protein of the vaccine virus). For analysis, two stool samples were collected per participant on separate days between Day 3 and Day 7 following each vaccination dose.|Between Day 3 and Day 7 following each of 3 doses of RotaTeq™/placebo|Only participants in Cohort III, infants that received the scheduled dose of vaccination, and for whom the stool samples were available for testing, were included in the analysis for that dose.||Participants|||Number
799284|NCT00953056|Primary|Number of Serious Adverse Events|The total number of serious adverse experiences (events) in participants up to 14 days post vaccination.|14 days post vaccination|||Events|||Number
799285|NCT00953056|Primary|Number of Participants With Serious Adverse Events|All serious adverse events (SAEs) were collected for 14 days following each dose to obtain the number of participants with serious adverse events.|up to 14 days post vaccination|||Participants|||Number
799286|NCT00953121|Secondary|Safety of Bevacizumab (Avastin) in Combination With Irinotecan and Carboplatin|Number of patients experiencing a toxicity greater than or equal to grade 2 treatment-related toxicity|34 months|||participants|||Number
799287|NCT00953121|Secondary|Median Overall Survival (OS)|Time in months from the start of study treatment to date of death due to any cause. Patients alive as of the last follow-up had OS censored at the last follow-up date. Median OS was estimated using a Kaplan-Meier curve.|40 months|||months||95% Confidence Interval|Median
799288|NCT00953121|Secondary|Median Progression Free Survival (PFS)|Time in months from the start of study treatment to the date of first progression according to RANO criteria, or to death due to any cause. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve.|40 months|||months||95% Confidence Interval|Median
799289|NCT00953121|Secondary|Objective Response Rate|Percentage of participants with an objective response (complete response or partial response) based on Response Assessment in Neuro-Oncology (RANO) criteria. A complete response is defined as disappearance of all enhancing tumor on contrast enhanced MRI scan. Patient must be off steroids or only on adrenal maintenance doses. A partial response is defined as greater than or equal to a 50% reduction in the size (products of the largest perpendicular diameters) for all enhancing lesions. No new lesions may arise. Steroids must be stable or decreasing dose.|34 months|The number of participants analyzed is lower than the total number in the study for each arm due to the fact that some patients progressed or experienced an adverse event which resulted in being taken off study during the first cycle and thus were never evaluated for radiographic response.||participants|||Number
799290|NCT00953121|Primary|6 Month Progression-free Survival|Percentage of participants surviving six months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to the Response Assessment in Neuro-Oncology (RANO) criteria, or to death due to any cause. Progression is defined as greater than or equal to a 25% increase in the product of the largest perpendicular diameters of any enhancing lesion or any new enhancing tumor on MRI scans. Patients may also be classified as progressive disease with significant neurologic decline felt to be due to underlying tumor and not attributable to co-morbid event or concurrent medication regardless of MRI findings.|6 months|||percentage of participants||95% Confidence Interval|Number
799291|NCT00953147|Secondary|Change From Baseline to Month 6 (Week 26) in RQLQ(S) Overall Score in Impaired Patients With Baseline RQLQ(S) Score ≥3.0.|RQLQ(S) scores in impaired subjects with baseline RQLQ[S] score ≥3.0. RQLQ(S)consists of 28 questions, each question measured on a scale of 0-6 where a higher score indicates poor quality of life. Domains: Activities (questions 1-3), Sleep (questions 4-6), Non-Nose/Eye Symptoms (questions 7-13), Practical Problems (questions 14-16), Nasal Symptoms (questions 17-20), Eye Symptoms (questions 21-24), and Emotional (questions 25-28). The overall RQLQ(S) score was calculated as the average of the mean domain scores.|Baseline and Week 26|Intent to Treat Population. Not all subjects analyzed due to missing data.||units on a scale||Standard Error|Least Squares Mean
799292|NCT00953147|Secondary|Change From Baseline to Week 6 in Rhinoconjunctivitis Quality of Life Questionnaire With Standardized [RQLQ(S)] Overall Score in Impaired Patients With Baseline RQLQ(S) Score ≥3.0|RQLQ(S) scores in subjects with baseline RQLQ[S] score ≥3.0. RQLQ(S) consists of 28 questions, each question measured on a scale of 0-6 where a higher score indicates poor quality of life. Domains: Activities (questions 1-3), Sleep (questions 4-6), Non-Nose/Eye Symptoms (questions 7-13), Practical Problems (questions 14-16), Nasal Symptoms (questions 17-20), Eye Symptoms (questions 21-24), and Emotional (questions 25-28). The overall RQLQ(S) score was calculated as the average of the mean domain scores.|Baseline and Week 6|Intent to Treat Population. Not all subjects analyzed due to missing data.||units on a scale||Standard Error|Least Squares Mean
799293|NCT00953147|Secondary|Change From Baseline in Daily Subject-reported AM and PM iNSS Averaged Over the First 6 Weeks of Double-blind Treatment Period|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Intent to Treat Population. Not all subjects analyzed due to missing data.||units on a scale||Standard Error|Least Squares Mean
799294|NCT00953147|Secondary|Change From Baseline in Daily Subject-reported PM iNSS Averaged the First 6 Weeks of the Double-blind Treatment|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Intent to Treat Population.||units on a scale||Standard Error|Least Squares Mean
799295|NCT00953147|Secondary|Change From Baseline in Daily Subject-reported AM iNSS Averaged the First 6 Weeks of the Double-blind Treatment|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Intent to Treat Population. Not all subjects analyzed due to missing data.||units on a scale||Standard Error|Least Squares Mean
799296|NCT00953147|Secondary|Change From Baseline in Daily Subject-reported AM & PM rNSS Averaged Over the First 6 Weeks of Double-blind Treatment Period.|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Intent to Treat Population. Not all subjects analyzed due to missing data.||units on a scale||Standard Error|Least Squares Mean
799297|NCT00953147|Secondary|Change From Baseline in Daily Subject-reported PM rNSS Averaged Over the First 6 Weeks of the Double-blind Treatment|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Intent to Treat Population. Not all subjects analyzed due to missing data.||units on a scale||Standard Error|Least Squares Mean
799314|NCT00953290|Secondary|Subject Satisfaction||Baseline and 6 months post final treatment|Data was not collected due to termination.||Participants|||Number
799315|NCT00953290|Primary|Difference in Circumference of Upper Thigh Between Treated and Untreated Control Arms|Mean difference of change from baseline between two arms: [Treated arm - Untreated arm]|Baseline and 6 months post final treatment|||cm|Participants|Standard Deviation|Mean
799316|NCT00953329|Primary|Treatment Alefacept|Terminated study|12 weeks (study terminated)|Study terminated|||||
799299|NCT00953147|Secondary|Change From Baseline in Daily Subject-reported PM iTNSS Averaged Over the First 6 Weeks of Double-blind Treatment.|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Intent to Treat Population. Not all subjects analyzed due to missing data.||units on a scale||Standard Error|Least Squares Mean
799300|NCT00953147|Secondary|Change From Baseline in Daily Subject-reported AM iTNSS Averaged Over the First 6 Weeks of Double-blind Treatment.|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Intent to Treat Population. Not all participants analyzed due to missing data.||units on a scale||Standard Error|Least Squares Mean
799301|NCT00953147|Secondary|Change From Baseline in Daily Subject-reported PM rTNSS Averaged Over the First 6 Weeks of Double-blind Treatment.|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Intent to Treat Population. Not all subjects analyzed due to missing data.||units on a scale||Standard Error|Least Squares Mean
799302|NCT00953147|Secondary|Change From Baseline in Daily Subject-reported AM rTNSS Averaged Over the First 6 Weeks of Double-blind Treatment.|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Intent to Treat Population. Not all subjects analyzed due to missing data.||units on a scale||Standard Error|Least Squares Mean
799303|NCT00953147|Secondary|Change From Baseline in Daily Subject-reported AM and PM Instantaneous TNSS (iTNSS) Averaged Over the First 6 Weeks of Double-blind Treatment|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Intent to Treat Population. Not all subjects analyzed due to missing data.||units on a scale||Standard Error|Least Squares Mean
799304|NCT00953147|Primary|Change From Baseline in Daily Subject-reported AM and PM Reflective TNSS (rTNSS) Averaged Over the First 6 Weeks of Double-blind Treatment|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Intent to Treat Population. Not all subjects analyzed due to missing data.||units on a scale||Standard Error|Least Squares Mean
799305|NCT00953160|Secondary|The Number of Participants With Adverse Events|At each visit (treatment and follow-up) or until resolution of AEs|Up to 6 months after the last treatment|||Participants|||Number
799306|NCT00953160|Secondary|Subject Satisfaction||Baseline and 6 months post final treatment||||||
799307|NCT00953160|Primary|Change in Circumference (cm)||Baseline and 6 months post final treatment|||Centimeters (cm)||Standard Deviation|Mean
799308|NCT00953199|Secondary|Serum Amylase Levels|serum amylase levels are measure by a blood draw|measurement is taken 2 hrs after ERCP|||units/liter||Full Range|Mean
799309|NCT00953199|Primary|Post ERCP Pancreatitis is the Primary Outcome.|The primary outcome of interest will be development of acute pancreatitis defined as new or worsening abdominal pain post-ERCP associated with an increase in serum amylase at least 3 times the upper limit of normal.|24-48 hours post-procedure|||participants|||Number
799312|NCT00953290|Primary|Difference in Circumference of Mid Thigh Between Treated and Untreated Control Arms|Mean difference of change from baseline between two arms: [Treated arm - Untreated arm]|Baseline and 6 months post final treatment|||cm|Participants|Standard Deviation|Mean
799313|NCT00953290|Secondary|Adverse Events||At each visit (treatment and follow-up) or until resolution of AEs|||Event|Participants||Number
799317|NCT00953407|Primary|Lens Awareness|Lens awareness, as interpreted by the subject, was reported by the subject as a single, retrospective evaluation of 4 week's wear time. Frequency of lens awareness was measured on a 4-point scale, with 1 being never and 4 being all the time. Four-week ratings were compared to baseline ratings, and a negative difference (4-week minus baseline) represented an improvement.|4 weeks of wear|Per protocol. Analysis excluded major protocol deviations as determined by masked review.||Participants|||Number
799318|NCT00953524|Primary|Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years|Solicited Injection Site Reactions: Pain, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), headache, malaise (feeling unwell), myalgia (muscle aches and pains), shivering (chills).|Days 0 to 7 post-vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.||Participants|||Number
799319|NCT00953524|Primary|Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years|Solicited Injection Site Reactions: Pain, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), headache, malaise (feeling unwell), myalgia (muscle aches and pains), shivering (chills).|Days 0 to 7 post-vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.||Participants|||Number
799320|NCT00953524|Primary|Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years|Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.|Pre-vaccination (Day 0) and 21 days post-vaccination|Antibody titers were assessed in the per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
799321|NCT00953524|Primary|Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years|Seroprotection: Antibody titer ≥ 40 1/dil. Antibody titers were determined by the hemagglutination inhibition (HAI) test.|Pre-vaccination (Day 0) and 21 days post-vaccination|Pre- and post-vaccination antibody titers were assessed in the per-protocol population.||Participants|||Number
799322|NCT00953524|Primary|Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1) Strain - Age ≥ 65 Years|Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.|Pre-vaccination (Day 0) and 21 days post-vaccination|Pre- and post-vaccination antibody titers were assessed in the per-protocol population.||Participants|||Number
799323|NCT00953524|Primary|Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years|Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.|Pre-vaccination (Day 0) and 21 days post-vaccination|Antibody titers were assessed in the per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
799324|NCT00953524|Primary|Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years|Seroprotection: Antibody titer ≥ 40 1/dil. Antibody titers were determined by the hemagglutination inhibition (HAI) test.|Pre-vaccination (Day 0) and Day 21 post-vaccination|Antibody titers were assessed in the per-protocol population.||Participants|||Number
799325|NCT00953524|Primary|Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years|Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.|Pre-vaccination (Day 0) and day 21 post-vaccination|Pre- and post-vaccination antibody titers were assessed in the per-protocol population.||Participants|||Number
799326|NCT00953615|Secondary|Soluble Tumor Necrosis Factor - Alpha|Assessment of effect from thalidomide on soluble tumor necrosis factor – alpha compared to baseline values were to be performed at study conclusion.|6 months, baseline|||pg/ml||Standard Deviation|Mean
799327|NCT00953615|Secondary|Mayo Risk Score|The Mayo Risk Score estimates the survival probability of a patient with primary sclerosing cholangitis based on the following variables: age, bilirubin, albumin, AST and history of variceal bleeding.|6 months|||units on a scale|||Number
799328|NCT00953615|Secondary|Overall Toxicity and Tolerability|Overall toxicity and tolerability were to be measured by the number of patients with development of neuropathy, increased liver biochemistries, drowsiness, dizziness and orthostatic hypotension.|6 months|||participants|||Number
799329|NCT00953615|Primary|Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase|The primary outcome was the change in serum liver biochemical parameter levels after 6 months of thalidomide when compared to baseline values. This was to be analyzed using the nonparametric Wilcoxon signed rank test of significance. This was based on the non-normal distribution of serum hepatic biochemical parameters among patients with PSC and the continuous nature of these variables.|6 months, baseline|Analysis was not performed because participant did not complete the study due to adverse events.||IU/L||Standard Deviation|Mean
799330|NCT00953654|Primary|Worry Symptoms|"Worry symptoms, hallmark symptoms of GAD, were assessed using the Penn State Worry Questionnaire (PSWQ). The PSWQ is a 16-item self-report questionnaire that measures pathological worry symptoms. Participants rate items from 1 not at all typical of me to 5 very typical of me. Scores range from 16 to 80, with higher scores indicated exacerbated worry symptoms. Symptoms were assessed at baseline and at the beginning of the second weekly session during weeks 2, 4, and 6."|Baseline, Week 2, Week 4, Week 6|||Units on a scale (PSWQ)|Participants|Standard Deviation|Mean
799331|NCT00953654|Primary|Generalized Anxiety Disorder (GAD) Remission as Measured by Anxiety Disorders Interview Schedule-Adult Version (ADIS-IV) Severity Ratings|GAD is characterized by persistent excessive or pathologic worry most days for at least 6 months about activities of daily life that is difficult to control and associated with at least 3 of the following symptoms: restlessness, feeling on edge, being easily fatigued, difficulty concentrating, irritability, muscle tension, and sleep difficulty. Symptoms are not caused by a substance or disorder, but cause significant distress or functional impairment. Remission was measured using the ADIS-IV from 1-16 days following the 6-week intervention.|Pre- and post- 6 week training intervention|||Participants|||Number
799332|NCT00953667|Secondary|Baseline and Peak C-Reactive Protein (CRP) Values as Categorized by Race and Gender||Baseline ( −15 min, −5 min), and 1, 2, 4, 6, 12, 18, and 24 hours post LPS|This analysis population was categorized by race and gender as follows: European American (EA) male n=102, African American (AA) male n=41, EU female n=91, and AA female n=60. Results include measurements at baseline and peak levels of C-Reactive Protein (CRP).||mg/L||Inter-Quartile Range|Median
799333|NCT00953667|Primary|Baseline and Peak TNF-alpha Values as Categorized by Race and Gender||Baseline (−15 min, −5 min), and 1, 2, 4, 6, 12, 18, and 24 hours post LPS|This analysis population was categorized by race and gender as follows: European American (EA) male n=102, African American (AA) male n=41, EU female n=91, and AA female n=60. Results include measurements at baseline and peak levels of Tumor Necrosis Factor- alpha (TNF-alpha).||pg/ml||Inter-Quartile Range|Median
799334|NCT00953680|Primary|Peak Plasma Concentration (Cmax) of HCTZ Following Single Dose Administration of Losartan/HCTZ or Losartan and HCTZ|Peak Plasma Concentration (Cmax), or maximal concentration of drug following dosing|30 Hours Post Dose|Pharmacokinetic (PK) results were based on data from the 20 subjects who had blood drawn for the HCTZ assay. These 20 subjects were selected as the first 10 subjects from each treatment sequence who completed both periods of the study.||ng/mL||Standard Deviation|Least Squares Mean
799335|NCT00953680|Primary|Area Under the Curve (AUC(0 to Infinity)) of HCTZ|Plasma Area Under the Curve, a measure of drug exposure following dosing|0 to 30 Hours Post Dose|Pharmacokinetic (PK) results included complete data from 75 of 77 subjects (with 1 replacement). Partial data from 1 subject were not analyzed. Plasma concentrations for another subject were undetectable following 1 treatment, with partial data excluded from analyses.||ng*hr/mL||Standard Deviation|Least Squares Mean
799336|NCT00953680|Primary|Peak Plasma Concentration (Cmax) for Losartan|Peak Plasma Concentration (Cmax), or maximal concentration of drug following dosing.|36 Hours Post Dose|Pharmacokinetic (PK) results included complete data from 75 of 77 subjects (with 1 replacement). Partial data from 1 subject were not analyzed. Plasma concentrations for another subject were undetectable following 1 treatment, with partial data excluded from analyses.||ng/mL||Standard Deviation|Least Squares Mean
799337|NCT00953680|Primary|Area Under the Curve (AUC(0 to Infinity)) of Losartan||0 to 36 Hours Post Dose|Pharmacokinetic (PK) results included complete data from 75 of 77 subjects (with 1 replacement). Partial data from 1 subject were not analyzed. Plasma concentrations for another subject were undetectable following 1 treatment, with partial data excluded from analyses.||ng*hr/mL||Standard Deviation|Least Squares Mean
799338|NCT00953706|Secondary|Part B : Number of Pulmonary Exacerbation Events Per Participant Per Year|Pulmonary exacerbation was defined as new, or changed, antibiotic therapy (intravenous, inhaled, or oral) for any 4 or more of the following signs/symptoms: change in sputum; new or increased hemoptysis; increased cough; increased dyspnea; malaise, fatigue, or lethargy; temperature above 38 degrees Celsius; anorexia or weight loss; sinus pain or tenderness; change in sinus discharge; change in physical examination of the chest; decrease in pulmonary function by 10 percent (%); and radiographic changes indicative of pulmonary infection.|Part B baseline through Week 64|Part B FAS.||events per participant per year|||Number
799339|NCT00953706|Secondary|Part B : Number of Pulmonary Exacerbation Events|Pulmonary exacerbation was defined as new, or changed, antibiotic therapy (intravenous, inhaled, or oral) for any 4 or more of the following signs/symptoms: change in sputum; new or increased hemoptysis; increased cough; increased dyspnea; malaise, fatigue, or lethargy; temperature above 38 degrees Celsius; anorexia or weight loss; sinus pain or tenderness; change in sinus discharge; change in physical examination of the chest; decrease in pulmonary function by 10 percent (%); and radiographic changes indicative of pulmonary infection.|Part B baseline through Week 64|Part B FAS.||events|||Number
799340|NCT00953706|Secondary|Part B : Number of Participants With Pulmonary Exacerbations|Pulmonary exacerbation was defined as new, or changed, antibiotic therapy (intravenous, inhaled, or oral) for any 4 or more of the following signs/symptoms: change in sputum; new or increased hemoptysis; increased cough; increased dyspnea; malaise, fatigue, or lethargy; temperature above 38 degrees Celsius; anorexia or weight loss; sinus pain or tenderness; change in sinus discharge; change in physical examination of the chest; decrease in pulmonary function by 10 percent (%); and radiographic changes indicative of pulmonary infection.|Part B baseline through Week 64|Part B FAS.||participants|||Number
799341|NCT00953706|Secondary|Part B : Absolute Change From Part A and Part B Baseline in Weight Through Week 64|As malnutrition is common in patients with cystic fibrosis (CF) because of increased energy expenditures due to lung disease and fat malabsorption, body weight is an important clinical measure of nutritional status.|Change from Part A baseline: Part A Baseline, Week 64; Change from Part B baseline: Part B Baseline (Week 16), Week 64|Part B FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.||kilograms (kg)||Standard Deviation|Mean
799342|NCT00953706|Secondary|Part B : Absolute Change From Part A and Part B Baseline in Sweat Chloride Concentration Through Week 64|The sweat chloride (quantitative pilocarpine iontophoresis) test is a standard diagnostic tool for cystic fibrosis (CF), serving as an indicator of cystic fibrosis transmembrane conductance regulator (CFTR) activity.|Change from Part A baseline: Part A Baseline, Week 64; Change from Part B baseline: Part B Baseline (Week 16), Week 64|Part B FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.||mmol/L||Standard Deviation|Mean
799343|NCT00953706|Secondary|Part B : Absolute Change From Part A and Part B Baseline in CFQ-R Respiratory Domain Score Through Week 64|The CFQ-R is a validated patient-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), score range: 0-100; Higher scores indicating fewer symptoms and better health-related quality of life.|Change from Part A baseline: Part A Baseline, Week 64; Change from Part B baseline: Part B Baseline (Week 16), Week 64|Part B FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.||units on a scale||Standard Deviation|Mean
799344|NCT00953706|Secondary|Part B : Rate of Change From Part B Baseline in ppFEV1 Through Week 64|ppFEV1 is defined in Outcome Measure 1.|Part B baseline through Week 64|Part B FAS.||percent predicted of FEV1 per 336 days||Standard Error|Least Squares Mean
799345|NCT00953706|Secondary|Part B : Rate of Change From Part A Baseline in ppFEV1 Through Week 64|ppFEV1 is defined in Outcome Measure 1.|Part A baseline through Week 64|Part B FAS.||percent predicted of FEV1 per 448 days||Standard Error|Least Squares Mean
799346|NCT00953706|Secondary|Part B : Absolute Change From Part A and Part B Baseline in ppFEV1 Through Week 64|ppFEV1 is defined in Outcome Measure 1.|Change from Part A baseline: Part A Baseline, Week 64; Change from Part B baseline: Part B Baseline (Week 16), Week 64|Part B FAS included all participants who received at least 1 dose of study drug during Part B. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.||percent predicted of FEV1||Standard Deviation|Mean
799347|NCT00953706|Secondary|Part A : Rate of Change From Baseline in Weight Through Week 16|As malnutrition is common in participants with cystic fibrosis (CF) because of increased energy expenditures due to lung disease and fat malabsorption, body weight is an important clinical measure of nutritional status.|Part A baseline through Week 16|Part A FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.||kilograms per 112 days||Standard Error|Least Squares Mean
799348|NCT00953706|Secondary|Part A : Absolute Change From Part A Baseline in Sweat Chloride Concentration Through Week 16|The sweat chloride (quantitative pilocarpine iontophoresis) test is a standard diagnostic tool for cystic fibrosis (CF), serving as an indicator of cystic fibrosis transmembrane conductance regulator (CFTR) activity.|Part A baseline through Week 16|Part A FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.||millimole per liter (mmol/L)||Standard Error|Least Squares Mean
799349|NCT00953706|Secondary|Part A : Absolute Change From Part A Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score Through Week 16|The CFQ-R is a validated patient-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), score range: 0-100; Higher scores indicating fewer symptoms and better health-related quality of life.|Part A baseline through Week 16|Part A FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.||units on a scale||Standard Error|Least Squares Mean
799350|NCT00953706|Primary|Part A : Absolute Change From Part A Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Through Week 16|Spirometry (as measured by ppFEV1) is a standardized assessment to evaluate lung function that is the most widely used endpoint in cystic fibrosis studies. FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. ppFEV1 (predicted for age, gender, and height) was calculated using the Knudson method.|Part A baseline through Week 16|Part A Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study drug during Part A. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.||percent predicted of FEV1||Standard Error|Least Squares Mean
799351|NCT00953719|Secondary|Proportion of Composite Successes|A subject was deemed to be a composite success at 24 months or greater if at the time of last clinical follow-up there had not been a revision of any THA components, the latest Harris Hip score was 80 or greater, and on the latest radiographic evaluation there were no radiolucencies greater than 2mm, no evidence of acetabular migration greater than 4mm, no change in acetabular shell inclination angle greater than 4 degrees, and no osteolysis.|At final follow-up visit, 24 months or later, up to 72 months|Per Protocol subjects with radiographic endpoints, and including subjects who have been revised (these are composite endpoint failures).||percentage of participants|||Number
799352|NCT00953719|Secondary|Harris Hip Score Longitudinal Analysis|The Harris Hip scoring system assigns a numeric value to responses from patients and assessments made by a surgeon, with a range of 0 to 100. Lower scores indicate a worse outcome and a score of 100 is the best possible outcome. Longitudinal analysis (repeated measures) was performed to compare post-operative Harris Hip sores over time.|6 week, 6 month, 12 month, 24 month, 36 month, and 48 months post-operatively|The population for this endpoint analysis is comprised of subjects who had Harris Hip scores at respective follow-up visits minus subjects who were found to have violated a protocol inclusion/exclusion criterion.||units on a scale||Standard Deviation|Mean
799353|NCT00953719|Secondary|Harris Hip Subscale Score: Range of Motion|The Harris Hip's Range of Motion subscale is a numeric value from 0 to 5. A lower score indicates a lower range of motion; a score of 5 indicates full range of motion.|At final follow-up visit, 24 months or later, up to 72 months|The population for this endpoint analysis is comprised of subjects who completed the study with a Harris Hip score at final follow-up visit, 24 months or later, through 72 months, minus subjects who were found to have violated a protocol inclusion/exclusion criterion.||units on a scale||Standard Deviation|Mean
799354|NCT00953719|Secondary|Harris Hip Subscale Score: Deformity|The Harris Hip's Deformity subscale is a numeric value from 0 to 4. A lower score indicates more deformity; a score of 4 indicates no deformity.|At final follow-up visit, 24 months or later, up to 72 months|The population for this endpoint analysis is comprised of subjects who completed the study with a Harris Hip score at final follow-up visit, 24 months or later, through 72 months, minus subjects who were found to have violated a protocol inclusion/exclusion criterion.||units on a scale||Standard Deviation|Mean
799355|NCT00953719|Secondary|Harris Hip Subscale Score: Activities|The Harris Hip's Activities subscale is a numeric value from 0 to 14. A lower score indicates a lower ability to perform daily activities; a score of 14 indicates no limitations in daily activities.|At final follow-up visit, 24 months or later, up to 72 months|The population for this endpoint analysis is comprised of subjects who completed the study with a Harris Hip score at final follow-up visit, 24 months or later, through 72 months, minus subjects who were found to have violated a protocol inclusion/exclusion criterion.||units on a scale||Standard Deviation|Mean
799356|NCT00953719|Secondary|Harris Hip Subscale Score: Function|The Harris Hip's function subscale is a numeric value from 0 to 33. A lower score indicates less function; a score of 33 indicates no limitations in function level.|At final follow-up visit, 24 months or later, up to 72 months|The population for this endpoint analysis is comprised of subjects who completed the study with a Harris Hip score at final follow-up visit, 24 months or later, through 72 months, minus subjects who were found to have violated a protocol inclusion/exclusion criterion.||units on a scale||Standard Deviation|Mean
799357|NCT00953719|Secondary|Harris Hip Subscale Score: Pain|The Harris Hip's pain subscale is a numeric value from 0 to 44. A lower score indicates more pain; a score of 44 indicates no pain.|At final follow-up visit, 24 months or later, up to 72 months|The population for this endpoint analysis is comprised of subjects who completed the study with a Harris Hip score at final follow-up visit, 24 months or later, through 72 months, minus subjects who were found to have violated a protocol inclusion/exclusion criterion.||units on a scale||Standard Deviation|Mean
799382|NCT00947115|Secondary|Total Immunoglobulin G (IgG) Antibody Titers in Serum|IgG antibody titers were expressed as GMTs in microgram per milliliter (µg/mL).|At Year 5, 6 and 7|The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity at Years 5, 6 and 7, which included all evaluable subjects that were included in the ATP cohort for immunogenicity of the primary study (NCT00196937) and for whom immunogenicity data at Years 5, 6 and 7 were available.||µg/mL||95% Confidence Interval|Geometric Mean
799358|NCT00953719|Primary|Total Harris Hip Score|The Harris Hip scoring system assigns a numeric value to responses from patients and assessments made by a surgeon. A score of 91-100 is excellent, 81-90 is good, 71-80 is fair, 70 or below is poor. The patient records the following: pain level, need for assistance when walking, presence of a limp, distance able to walk, ability to put on shoes and socks, climb stairs, use public transportation and the length of time one is able to comfortably sit in a chair are all scored. The Total Harris Hip Score is a sum of its subscores (Pain, Function, Activities, Deformity, and Range of Motion).|At final follow-up visit, 24 months or later, up to 72 months|The population for this primary endpoint analysis is comprised of subjects who completed the study with a Harris Hip score at final follow-up visit, 24 months or later, through 72 months, minus subjects who were found to have violated a protocol inclusion/exclusion criterion.||units on a scale||Standard Deviation|Least Squares Mean
799359|NCT00946920|Secondary|Change in International Prostate Symptom Score (IPSS) Score at Months 1, 4, 7, and 13 Compared to Baseline|"IPSS is used to assess severity of lower urinary tract symptoms and to monitor the progress of symptoms once treatment has been initiated. It contains 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5 (i.e. the minimum total score is 0 and the maximum is 35). A score of 0 corresponds to a response of not at all for the first six symptoms and none for nocturia, and a score of 5 corresponds to a response of almost always for the first six symptoms and 5 times or more for nocturia."|At baseline, 1 month, 4 months, 7 months and 13 months|FAS.||units on a scale||Standard Deviation|Mean
799360|NCT00946920|Secondary|Change in Health-related Quality of Life (HRQoL), as Measured by Short Form-36 (SF-36) Score at Month 10 and Month 13 Compared to Baseline|The SF-36 is a multi-purpose, short-form health survey with only 36 questions and with a minimum score of 0 and a maximum score of 100. The higher score the better health. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The SF-36 has proven useful in surveys of general and specific populations, comparing the relative burden of diseases, and in differentiating the health benefits produced by a wide range of different treatments.|At baseline, 10 months and 13 months|FAS.||units on a scale||Standard Deviation|Mean
799361|NCT00946920|Secondary|Percent Change in Serum Levels of Prostate-specific Antigen (PSA) Over Time|Serum PSA levels are presented as mean percent change from Baseline (in Baseline measures) after 1, 2, 3, 6 and 13 months. One treatment month equals 28 days.|Baseline and after 1, 2, 3, 6 and 13 months|FAS.||percent change||Standard Deviation|Mean
799362|NCT00946920|Secondary|Serum Levels of Testosterone Over Time|Median testosterone levels are presented as absolute values at Baseline (in Baseline measures) and after 1, 2, 3, 6 and 13 months (below). One treatment month equals 28 days.|Baseline and after 1, 2, 3, 6 and 13 months|FAS.||ng/mL||Full Range|Median
799363|NCT00946920|Primary|Difference in Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) Between Degarelix and Goserelin|This co-primary outcome measure was used to establish non-inferiority of degarelix as compared to goserelin with regard to achieving and maintaining testosterone suppression at castrate levels (≤0.5 ng/mL) from Day 3 to Day 364, using a non-inferiority margin of 5 percentage points.|Day 3 to Day 364|FAS.||percentage of participants||95% Confidence Interval|Number
799364|NCT00946920|Primary|Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) With Degarelix|This co-primary outcome measure was used to demonstrate that degarelix is effective with respect to achieving and maintaining testosterone suppression to castrate levels, evaluated as the proportion of patients with testosterone suppression ≤0.5 ng/mL from Day 28 to Day 364.|From Day 28 to Day 364|FAS.||percentage of participants||95% Confidence Interval|Number
799365|NCT00946985|Primary|Time to Relapse During Relapse Prevention Phase|Time to relapse during the relapse prevention phase was the primary efficacy variable of the study. Each case of potential relapse event were to be reviewed in a blinded fasion by an independent Relapse Monitoring Board, comprised of experts in the diagnostic, clinical and therapeutic management of schizophrenia.|24 months|The analysis population was to include all randomized patients who took at least one dose of study medication (ITT population). However, due to early study termination, only 2 patients were randomized and they did not have sufficient follow up. Hence the planned efficacy analysis could not be carried out.|||||
799366|NCT00947011|Secondary|Peripheral Glucose Utilization and Peripheral Glucagon Release||one year|Data was not collected for this outcome measure. The study was terminated. The P.I. left the institution.|||||
799367|NCT00947011|Primary|Insulin Release Rate and Hepatic Glucose Release||One year|Data was not collected for this outcome measure. The study was terminated. The P.I. left the institution.|||||
799368|NCT00947115|Secondary|Number of Subjects With Any Fatal or Vaccine-related Serious Adverse Events (SAEs) (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication).|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Year 0 up to Year 10|The analysis was performed on the Total Vaccinated cohort that included all vaccinated subjects (i.e. all subjects who received 3 doses of HPV vaccine in the primary study [NCT00196937]) for whom data were available throughout the study.||Subjects|||Number
799369|NCT00947115|Secondary|Number of Subjects With Any Fatal or Vaccine-related Serious Adverse Events (SAEs) (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Month 108 (Year 9) to the Month 120 (Year 10) visit|The analysis was based on the Total Vaccinated cohort at Year 10, which included all vaccinated subjects (i.e. all subjects who received 3 doses of HPV vaccine in the primary study [NCT00196937]) for whom data were available at Year 10.||Subjects|||Number
799399|NCT00947284|Primary|Change in Skin Sensitivity as Measured by a Visual Analog Scale|Participants would have been asked to rate the level of pain on a scale from 0 (no pain) to 10 (worst pain imaginable).|Prior to drug administration and 20 minutes, 70 minutes and 2 hours after each drug administration|The planned model of skin irritation could not be reproduced on 3 enrolled participants, thus the investigator did not obtain outcome data.|||||
799400|NCT00947297|Secondary|Patient Satisfaction With HPN-100|Drug preference will be noted at week 3|Month 1 post dose|all available questionnaires||% preferred HPN-100|||Number
799370|NCT00947115|Secondary|Number of Subjects With Any Fatal or Vaccine-related Serious Adverse Events (SAEs) (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication).|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Month 96 (Year 8) to the Month 108 (Year 9) visit|The analysis was based on the Total Vaccinated cohort at Year 9, which included all vaccinated subjects (i.e. all subjects who received 3 doses of HPV vaccine in the primary study [NCT00196937]) for whom data were available at Year 9.||Subjects|||Number
799371|NCT00947115|Secondary|Number of Subjects With Any Fatal or Vaccine-related Serious Adverse Events (SAEs) (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication).|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Month 84 (Year 7) to the Month 96 (Year 8) visit|The analysis was based on the Total Vaccinated cohort at Year 8, which included all vaccinated subjects (i.e. all subjects who received 3 doses of HPV vaccine in the primary study [NCT00196937]) for whom data were available at Year 8.||Subjects|||Number
799372|NCT00947115|Secondary|Number of Subjects With Any Fatal or Vaccine-related Serious Adverse Events (SAEs) (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication).|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Month 72 (Year 6) visit to Month 84 (Year 7) visit|The analysis was based on the Total Vaccinated cohort at Year 7, which included all vaccinated subjects (i.e. all subjects who received 3 doses of HPV vaccine in the primary study [NCT00196937]) for whom data were available at Year 7.||Subjects|||Number
799373|NCT00947115|Secondary|Number of Subjects With Any Fatal or Vaccine-related Serious Adverse Events (SAEs) (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication).|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From the Month 60 (Year 5) visit until the Month 72 (Year 6) visit|The analysis was based on the Total Vaccinated cohort at Year 6, which included all vaccinated subjects (i.e. all subjects who received 3 doses of HPV vaccine in the primary study [NCT00196937]) for whom data were available at Year 6.||Subjects|||Number
799374|NCT00947115|Secondary|Number of Subjects With Any Fatal or Vaccine-related Serious Adverse Events (SAEs) (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication).|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Month 48 in primary study (NCT00196937) up to Month 60 (Year 5)|The analysis was based on the Total Vaccinated cohort at Year 5, which included all vaccinated subjects (i.e. all subjects who received 3 doses of HPV vaccine in the primary study [NCT00196937]) for whom data were available at Year 5.||Subjects|||Number
799375|NCT00947115|Secondary|Total Immunoglobulin G (IgG) Antibody Titers in Serum|IgG antibody titers were expressed as GMTs in microgram per milliliter (µg/mL).|At Years 8, 9 and 10|The analysis was performed on the Total Vaccinated Cohort at Years 8, 9 and 10, which included all vaccinated subjects (i.e. all subjects who received 3 doses of HPV vaccine in the primary study NCT00196937) for whom data were available at the concerned year.||µg/mL||95% Confidence Interval|Geometric Mean
799376|NCT00947115|Secondary|Total Immunoglobulin G (IgG) Antibody Titers in Serum|IgG antibody titers were expressed as GMTs in microgram per milliliter (µg/mL).|At Year 5, 6 and 7|The analysis was performed on the Total Vaccinated Cohort at Years 5, 6 and 7, which included all vaccinated subjects (i.e. all subjects who received 3 doses of HPV vaccine in the primary study NCT00196937) for whom data were available at the concerned year.||µg/mL||95% Confidence Interval|Geometric Mean
799377|NCT00947115|Secondary|Total Immunoglobulin G (IgG) Secretion Antibody Titers in CVS|Titers were given as GMTs expressed in microgram per milliliter (µg/mL)|At Years 7, 8, 9, 10|Analysis was performed on the subset of subjects from the Total Vaccinated Cohort who volunteered for CVS sample collection at Years 7, 8, 9, 10 and for whom their CVS sample contained less than 200 erythrocytes per microliter.||µg/mL||95% Confidence Interval|Geometric Mean
799378|NCT00947115|Secondary|Total Immunoglobulin G (IgG) Secretion Antibody Titers in CVS|Titers were given as GMTs expressed in microgram per milliliter (µg/mL).|At Year 5 and Year 6|Analysis was performed on the subset of subjects from the Total Vaccinated Cohort who volunteered for CVS sample collection at Year 5 and Year 6 and for whom their CVS sample contained less than 200 erythrocytes per microliter.||µg/mL||95% Confidence Interval|Geometric Mean
799379|NCT00947115|Secondary|Anti-HPV-16/18 Secretion Antibody Titers in Cervico-vaginal Secretion (CVS)|Anti-HPV-16/18 titers in CVS were given as GMTs expressed in ELISA units per milliliter (EL.U/mL).|At Years 7, 8, 9, 10|Analysis was performed on the subset of subjects from the Total Vaccinated Cohort who volunteered for CVS sample collection at Year 5 and Year 6 and for whom their CVS sample contained less than 200 erythrocytes per microliter.||EL.U/mL||95% Confidence Interval|Geometric Mean
799380|NCT00947115|Secondary|Anti-HPV-16/18 Secretion Antibody Titers in Cervico-vaginal Secretion (CVS)|Anti-HPV-16/18 titers in CVS were given as GMTs expressed in ELISA units per milliliter (EL.U/mL).|At Year 5 and Year 6|Analysis was performed on the subset of subjects from the Total Vaccinated Cohort who volunteered for CVS sample collection at Year 5 and Year 6 and for whom their CVS sample contained less than 200 erythrocytes per microliter.||EL.U/mL||95% Confidence Interval|Geometric Mean
799381|NCT00947115|Secondary|Total Immunoglobulin G (IgG) Antibody Titers in Serum|IgG antibody titers were expressed as GMTs in microgram per milliliter (µg/mL).|At Years 8, 9 and 10|The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity at Years 8, 9 and 10, which included all evaluable subjects that were included in the ATP cohort for immunogenicity of the primary study (NCT00196937) and for whom immunogenicity data at Years 8, 9 and 10 were available.||µg/mL||95% Confidence Interval|Geometric Mean
799401|NCT00947297|Secondary|Blood Ammonia Levels|Venous Ammonia levels over time|1 Year|||Umol/L||Standard Deviation|Mean
799402|NCT00947297|Secondary|Number and Causes of Hyperammonemic Events|Number of hyperammonemic crises per patient|1 year|||hyperammonemic events||Standard Deviation|Mean
799383|NCT00947115|Primary|Number of Seroconverted Subjects.|Seroconversion was defined as the appearance of antibodies (i.e. anti-HPV-16 and anti-HPV-18 antibody titers respectively greater than or equal to 19 and 18 EL.U/mL) in the serum of subjects seronegative before vaccination in the primary study.|At Years 8, 9 and 10|The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity at Years 8, 9 and 10, which included all evaluable subjects that were included in the ATP cohort for immunogenicity of the primary study (NCT00196937) and for whom immunogenicity data at Years 8, 9 and 10 were available.||Subjects|||Number
799384|NCT00947115|Primary|Number of Seroconverted Subjects.|Seroconversion was defined as the appearance of antibodies (i.e. anti-HPV-16 and anti-HPV-18 antibody titers respectively greater than or equal to 8 and 7 EL.U/mL) in the serum of subjects seronegative before vaccination in the primary study.|At Year 5, 6 and 7|The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity at Years 5, 6 and 7, which included all evaluable subjects that were included in the ATP cohort for immunogenicity of the primary study (NCT00196937) and for whom immunogenicity data at Years 5, 6 and 7 were available.||Subjects|||Number
799385|NCT00947115|Primary|Anti-Human Papillomavirus (Anti-HPV) 16/18 Antibody Titers in Serum|Seroconversion was defined as the appearance of antibodies (i.e. anti-HPV-16 and anti-HPV-18 antibody titers respectively greater than or equal to 19 and 18 EL.U/mL) in the serum of subjects seronegative before vaccination in the primary study.|At Years 8, 9 and 10|The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity at Years 8, 9 and 10, which included all evaluable subjects that were included in the ATP cohort for immunogenicity of the primary study (NCT00196937) and for whom immunogenicity data at Years 8, 9 and 10 were available.||EU/mL||95% Confidence Interval|Geometric Mean
799386|NCT00947115|Primary|Anti-Human Papillomavirus (Anti-HPV) 16/18 Antibody Titers in Serum|Titers were expressed as Geometric Mean Titer (GMT) in Enzyme-Linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL).|At Year 5, 6 and 7|The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity at Years 5, 6 and 7, which included all evaluable subjects that were included in the ATP cohort for immunogenicity of the primary study (NCT00196937) and for whom immunogenicity data at Years 5, 6 and 7 were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
799387|NCT00947154|Secondary|Clinical Global Impressions Improvement (CGI-I)|The CGI-I is a clinician rated scale ranging from 0 (not assessed) to 7 (very much worse), with intermediate scores of 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse). The clinician is rating the overall change in the patient's clinical condition.|At week 8|11 participants. 1 participant lost to follow up after week 1||percentage completers with score 1 or 2|||Number
799388|NCT00947154|Primary|Mass General Hair Pulling Scale, Actual Pulling Subscale|Sum of scores for items 4, 5 and 6 from the Mass General Hair Pulling Scale (Frequency of Pulling, Attempts to Resist Pulling, Control Over Hair Pulling). Score can range from 0 to 12; higher scores indicate more severe hair pulling.|change from baseline to end of week 8|11 participants. 1 participant was lost to follow-up after week 1.||units on a scale||Standard Deviation|Mean
799389|NCT00947154|Secondary|CGI-I Score of 1 or 2 (Very Much or Much Improved)|CGI = Clinical Global Improvement 7-item scale, from very much worse to very much better.|At week 8|11 of the 12 subjects initially enrolled. One subject was lost to follow-up after the baseline visit.||participants|||Number
799390|NCT00947154|Primary|Mass General Hair Pulling Scale|A brief, self-report instrument for assessing repetitive hairpulling. Seven individual items, rated for severity from 0 to 4, assess frequency and intensity of urges to pull, ability to control the urges, frequency of pulling, attempts to resist pulling, success in resisting, and associated distress. Statistical analyses indicate that the seven items form a homogenous scale for the measurement of severity in trichotillomania. Higher scores indicate greater severity of hair pulling. Total score can range from 0 to 28.|Change from baseline to week 8|11 of the 12 subjects initially enrolled. One was lost to follow-up after baseline visit.||units on a scale||Standard Deviation|Mean
799391|NCT00947167|Secondary|Toxicities Assessed by CTCAE Grading Criteria and Assigned Attributions Accordingly|by CTCAE|AEs are assessed every cycle (every 3 wks)|whole cohort||Participants|||Count of Participants
799392|NCT00947167|Primary|Response Rate (RR) for All Patients Treated With This Strategy (Simon Design)|RECIST v1.1 used|CT scans are done every 4 cycles (every 12 wks)|whole cohort||Participants|||Count of Participants
799393|NCT00947219|Primary|Changes in Terminal Hair Count at 16 and 26 Weeks Compared to Baseline in Men Diagnosed With Androgenetic Alopecia|The primary analysis of effectiveness was an analysis of covariance, which separately modeled terminal hair count at Week 16 and Week 26 as a function of treatment group (HairMax LaserComb 2009 9 Beam vs.control), study center, age (as a continuous variable), and Fitzpatrick Skin Type classification (as a categorical variable with four levels). The active group was compared to the control device using least squares means with a two-sided test at the 5% level of significance.|baseline, 16 and 26 weeks|||hairs per cm^2|Participants|Standard Deviation|Mean
799394|NCT00947271|Primary|Number of Sexual Partners, 12 Months Post Intervention|number of sexual partners in the past 3 months, assessed 12 months post intervention|12 months post intervention|||number of partners||Standard Error|Least Squares Mean
799395|NCT00947271|Primary|Number of Sexual Partners, 9 Months Post Intervention|number of sexual partners in the past 3 months, assessed 9 months post intervention|9 months post intervention|||number of partners||Standard Error|Least Squares Mean
799396|NCT00947271|Primary|Number of Sexual Partners, 6 Months Post Intervention|number of sexual partners reported in the past 3 months, assessed 6 months post intervention.|6 months post intervention|||number of partners||Standard Error|Least Squares Mean
799397|NCT00947271|Secondary|Sexually Transmitted Infection Incidence|number of participants diagnosed with a new STI (CT, Gc, trichomoniasis, syphilis, or HIV) throughout the entire year of follow-up; includes participants who provided a study urine sample for STI testing at 3, 6, 9, and/or 12 months post intervention and participants who received STI testing through the clinic during the year of follow up|Measured throughout the 12 months post intervention|Participants who provided a urine sample for STI testing at any study follow up (3, 6, 9, or 12 months) OR who had STI testing performed at the STI clinic during the 12 months post intervention were included in these analyses||participants diagnosed with any STI|||Number
799398|NCT00947271|Primary|Number of Sexual Partners, 3 Months Post Intervention|number of sexual partners in the past 3 months, assessed 3 months post intervention|Measured after 3 months|||number of partners||Standard Error|Least Squares Mean
799410|NCT00947349|Secondary|Cmin,ss for RBV|Minimum concentration of the analyte (RBV) in plasma over the dosing interval at steady state|10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose|PKS||ng/mL||Geometric Coefficient of Variation|Geometric Mean
799411|NCT00947349|Secondary|Cmin,ss for BI 201335 ZW|Minimum concentration of the analyte (BI 201335 ZW) in plasma over the dosing interval at steady state|10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose|PKS||ng/mL||Geometric Coefficient of Variation|Geometric Mean
799412|NCT00947349|Secondary|t1/2,ss for BI 201335 ZW|terminal half-life of the analyte in plasma at steady state (t1/2,ss)|10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose|PKS||hour(s)||Geometric Coefficient of Variation|Geometric Mean
799413|NCT00947349|Secondary|Tmax, ss for RBV|Time to the maximum plasma concentration (tmax) of RBV after the last dose of BI 201335 NA with RBV and PegIFN alfa-2a at steady state|10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose|PKS||hour(s)||Full Range|Median
799414|NCT00947349|Secondary|Tmax, ss for BI 201335 ZW|Time from last dosing to the maximum plasma concentration (tmax) of BI 201335 ZW after the last dose of BI 201335 NA with RBV and PegIFN alfa-2a at steady state|10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose|PKS||hour(s)||Full Range|Median
799415|NCT00947349|Secondary|Tmax for RBV|Time to maximum plasma concentration (tmax) of RBV after the first dose of BI 201335 NA with RBV and PegIFN alfa-2a|10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the first dose|PKS||hour(s)||Full Range|Median
799416|NCT00947349|Secondary|Tmax for BI 201335 ZW|Time to maximum plasma concentration (tmax) of BI 201335 ZW after the first dose of BI 201335 NA with RBV and PegIFN alfa-2a|10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the first dose|PKS||hour(s)||Full Range|Median
799417|NCT00947349|Secondary|Cmax,ss of RBV|Maximum Plasma concentration of RBV after multiple oral admin. of BI 201335 NA (or placebo) with RBV and PegIFN alfa-2a at steady state|-0:10, 1,2,3,4,5,6,8,10,11:50, 23:50 hours on the last dose|The pharmacokinetic analysis set (PKS) consisted of all randomised patients who took at least one dose of investigational products and with at least one on treatment blood sample available.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
799418|NCT00947349|Secondary|AUCτ,ss of RBV|Area under the plasma concentration curve of RBV after the multiple oral administration of BI 201335 NA (or placebo) with RBV and PegIFN alfa-2a at steady state|-0:10, 1,2,3,4,5,6,8,10,11:50, 23:50 hours on the last dose|The pharmacokinetic analysis set (PKS) consisted of all randomised patients who took at least one dose of investigational products and with at least one on treatment blood sample available.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
799419|NCT00947349|Secondary|Cmax of RBV|Maximum Plasma concentration of RBV after multiple oral admin. of placebo with RBV and PegIFN alfa-2a|-0:10, 1,2,3,4,5,6,8,10,11:50, 23:50 hours on the first dose|The pharmacokinetic analysis set (PKS) consisted of all randomised patients who took at least one dose of investigational products and with at least one on treatment blood sample available.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
799420|NCT00947349|Primary|Assessment of Tolerability in Triple Combination Therapy|An assessment of tolerability for the safety of the triple combination therapy with BI 201335 NA, PegIFN α -2a and RBV.|4 weeks|The treated set (TS) consisted of all patients who were given study medication and were documented to have taken at least one dose of investigational products regardless of randomisation.||participants|||Number
799421|NCT00947349|Secondary|AUCτ,1 for Ribavirin (RBV)|Area under the plasma concentration curve of RBV after the first dose of placebo or BI 201335 NA with with RBV and PegIFN alfa-2a|-0:10, 1,2,3,4,5,6,8,10,11:50, 23:50 hours on the first dose|The pharmacokinetic analysis set (PKS) consisted of all randomised patients who took at least one dose of investigational products and with at least one on treatment blood sample available.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
799422|NCT00947349|Secondary|Cmax,ss of BI 201335 ZW|Maximum concentration of BI 201335 ZW at steady state|10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose|The pharmacokinetic analysis set (PKS) consisted of all randomised patients who took at least one dose of investigational products and with at least one on treatment blood sample available.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
799423|NCT00947349|Secondary|AUCτ,ss of BI 201335 ZW|AUC at steady state after 4 weeks combination of the last dose|10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose|The pharmacokinetic analysis set (PKS) consisted of all randomised patients who took at least one dose of investigational products and with at least one on treatment blood sample available.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
799424|NCT00947349|Secondary|Cmax of BI 201335 ZW|Maximum concentration of BI 201335 ZW after multiple oral admin. of BI 201335 NA with RBV and PegIFN alfa-2a|10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the first dose|The pharmacokinetic analysis set (PKS) consisted of all randomised patients who took at least one dose of investigational products and with at least one on treatment blood sample available.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
799425|NCT00947349|Secondary|AUCτ,1 for BI 201335 ZW|Area under the curve (AUC) concentration after the first dose of BI 201335 ZW|10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the first dose|The pharmacokinetic analysis set (PKS) consisted of all randomised patients who took at least one dose of investigational products and with at least one on treatment blood sample available.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
799426|NCT00947349|Secondary|Assessment of Tolerability in Standard of Care (SOC) With PegIFN α -2a and RBV|An assessment of tolerability for the safety of the SOC with PegIFN alfa-2a and RBV.|44 weeks|TS||participant(s)|||Number
799427|NCT00947349|Secondary|Number of Patients With Possible Clinically Significant Laboratory Abnormalities in Standard of Care (SOC) With PegIFN α-2a and RBV|Frequency of patients with possible clinically significant abnormalities or clinically significant laboratory test value changes over time in SOC period for treatment naive patients and treatment experienced patients.|44 weeks|TS||participant(s)|||Number
799449|NCT00947531|Secondary|Change From Baseline in ADCS-ADL (Alzheimer's Disease Cooperative Study-Activities of Daily Living Scale)|The ADCS-ADL is a measure of functional disability. The ADCS-ADL assessment of activities of daily living is based on an interview with the caregiver.|week 4, 12, 16, 24||||||
799428|NCT00947349|Secondary|Number of Participants With Investigator Defined Drug-related Adverse Events in Standard of Care (SOC) With PegIFN α-2a and RBV|Drug-related AEs in SOC treatment period were defined as those whose causal relationship with any one of the investigational products was considered by the investigator.|44 weeks|The treated set (TS) consisted of all patients who were given study medication and were documented to have taken at least one dose of investigational products regardless of randomisation.||participant(s)|||Number
799429|NCT00947349|Secondary|Sustained Virologic Response (SVR)|Number of patients with plasma HCV RNA level BLD 24 weeks after treatment completion|72 weeks|The full analysis set (FAS) consisted of all randomised patients who were given investigational products and were documented to have taken at least one dose of study medication.||participants|||Number
799430|NCT00947349|Secondary|End of Treatment Response (ETR)|Number of patients with plasma HCV RNA level BLD at week 48|48 weeks|The full analysis set (FAS) consisted of all randomised patients who were given investigational products and were documented to have taken at least one dose of study medication.||participants|||Number
799431|NCT00947349|Secondary|Complete Early Virological Response (cEVR)|Number of patients with plasma HCV RNA level BLD at Week 12|12 weeks|The full analysis set (FAS) consisted of all randomised patients who were given investigational products and were documented to have taken at least one dose of study medication.||participants|||Number
799432|NCT00947349|Secondary|Early Virological Response (EVR)|Number of patients with reduction >= 2 log10 in plasma HCV RNA level at Week 12|12 Weeks|The full analysis set (FAS) consisted of all randomised patients who were given investigational products and were documented to have taken at least one dose of study medication.||participants|||Number
799433|NCT00947349|Secondary|Day 28 Virologic Response|Number of patients with HCV viral load reduction >= 2 log10 at Week 4|4 weeks|The full analysis set (FAS) consisted of all randomised patients who were given investigational products and were documented to have taken at least one dose of study medication.||participants|||Number
799434|NCT00947349|Secondary|Change From Baseline in HCV Viral Load|Change form baseline in HCV viral load (log10) after 4 weeks|baseline and week 4|The full analysis set (FAS) consisted of all randomised patients who were given investigational products and were documented to have taken at least one dose of study medication.||IU/mL||Standard Error|Mean
799435|NCT00947349|Secondary|Rapid Virological Response (RVR)|Number of patients satisfying RVR (plasma HCV RNA level below the limit of detection (BLD) at Week 4)|4 weeks|The full analysis set (FAS) consisted of all randomised patients who were given investigational products and were documented to have taken at least one dose of study medication.||participants|||Number
799436|NCT00947349|Secondary|Week 4 Virological Response (W4VR)|Number of patients satisfying W4VR (plasma HCV RNA level below the limit of quantification (BLQ))|4 weeks|The full analysis set (FAS) consisted of all randomised patients who were given investigational products and were documented to have taken at least one dose of study medication.||participants|||Number
799437|NCT00947349|Secondary|Week 2 Virological Response (W2VR)|Number of patients satisfying W2VR (plasma HCV RNA (Hepatitis C Virus Ribonucleic acid) level below the limit of quantification (BLQ))|2 weeks|The full analysis set (FAS) consisted of all randomised patients who were given investigational products and were documented to have taken at least one dose of study medication.||participants|||Number
799438|NCT00947349|Primary|Number of Patients With Possible Clinically Significant Laboratory Abnormalities in Triple Combination Therapy|Frequency of patients with possible clinically significant abnormalities or clinically significant laboratory test value changes over time in triple combination therapy for treatment naive patients and treatment experienced patients.|4 weeks|The treated set (TS) consisted of all patients who were given study medication and were documented to have taken at least one dose of investigational products regardless of randomisation.||participants|||Number
799439|NCT00947349|Primary|Number of Participants With Investigator Defined Drug-related Adverse Events in Triple Combination Therapy|Drug-related AEs were defined as those whose causal relationship with any one of the investigational products was considered by the investigator.|4 weeks|The treated set (TS) consisted of all patients who were given study medication and were documented to have taken at least one dose of investigational products regardless of randomization randomisation.||participants|||Number
799440|NCT00947427|Primary|C-peptide Response to Mixed Meal Glucose Tolerance Test (MMTT) at One Year for Subjects Given Canakinumab Compared to Placebo|The primary outcome is the area under the stimulated C-peptide curve (AUC) based on data collected at time 0 to 2 hours of a 4-hour mixed meal glucose tolerance test (MMTT) conducted at the primary endpoint visit. The timed measurements are done at: 0, 15, 30 60, 90, and 120 minutes. The calculation for the concentration of c-peptide is a weighted average of the 6 timed measurements of c-peptide in nano-moles/Liter. We try to distinguish this calculation from the AUC by referring to it as the “AUC mean” and may be expressed algebraically as the AUC/(120 min.); thus, the units are the same as the y-axis.|12 months|||nmol/L||95% Confidence Interval|Geometric Mean
799441|NCT00947505|Primary|Changes in Terminal Hair Count at 16 and 26 Weeks Over Baseline|Results of terminal hair count will be compared to baseline for each user between active and control devicea at 26 weeks with an interim evaluation at week 16. Terminal hair count, which is non-vellus/non-miniaturized hair counts, will be assessed in the target region|16 and 26 weeks|||change in terminal hair count||Standard Deviation|Mean
799442|NCT00947518|Secondary|Incidence of Clinical and Culture Positive Sepsis||First week of life.||09/2009||||
799443|NCT00947518|Primary|Number of Participants With Positive Skin Culture at Axilla|Occurrence of any bacterial flora irrespective of the colony count in the skin swabs from axilla at 24 hrs after intervention|24 hours after intervention|||participants|||Number
799444|NCT00947518|Primary|Skin Temperature at 30 Min After Intervention|Axillary skin temperature measured by a clinical thermometer kept in axilla for 3 minutes|at 30 min after intervention|||Degree Celsius||Standard Deviation|Mean
799445|NCT00947518|Primary|Median Skin Condition Score on the 9-point Skin Condition Grading Scale Adapted by Darmstadt From Lane et al|The skin condition grading scale assesses the condition of the skin on the abdomen and dorsum of the hands/feet based on drying, erythema, crusting, oozing, etc. on a continuous scale from 1 (normal) to 9 (vesicles or pustules)|At 24 hours|||score on a scale||Full Range|Median
799446|NCT00947531|Secondary|Combined Response, i.e. Response in ADAS-COG+ and CIBIC+||week 4, 12, 16, 24||||||
799447|NCT00947531|Secondary|Change From Baseline in Clock-drawing Test|The Clock-drawing test is a frequently used screening instrument for dementia drug studies. It evaluates executive function of demented patients.|week 4, 12, 16, 24||||||
799450|NCT00947531|Secondary|Change From Baseline in MMSE (Mini-Mental State Examination) Score|The Mini-Mental State Examination (MMSE) is a frequently used screening instrument for clinical trials conducted in patients with Alzheimer’s Disease. It evaluates orientation, registration, attention and calculation, recall and language.|week 4, 12, 16, 24||||||
799451|NCT00947531|Secondary|CIBIS+ (Clinicians Interview-Based Impression of Severity)|The Clinician Interview-based Impression of Disease Severity (CIBIS+) score is assigned by an experienced physician, familiar with the manifestations of dementia, after interviewing the patient and the caregiver.|week 24||||||
799452|NCT00947531|Secondary|CIBIC+ Response|A patient with a CIBIC+ score of 1 to 3 at a particular visit is considered to have a CIBIC+ response at that visit. Patients with a score of 0, indicating that the assessment was not performed, are considered to be non-responders.|week 4, 12, 16, 24||||||
799453|NCT00947531|Secondary|CIBIC+ Sscore|The Clinician Interview-based Impression of Change (CIBIC+) score is assigned by an experienced physician familiar with the manifestations of dementia after interviewing the patient and the caregiver.|week 4, 12, 16||||||
799454|NCT00947531|Secondary|Change From Baseline for Original ADAS-COG|The Original Alzheimer’s Disease Assessment Scale – Cognitive (ADAS-COG) is comprised of items 1-11 of the modified ADAS-COG+.|week 4, 12, 16, 24||||||
799455|NCT00947531|Secondary|ADAS-COG+ Response|A patient with an improvement from baseline of ≥ 4 points in the ADAS-COG+ score at a particular visit is considered to have an ADAS-COG+ response at that visit.|week 4, 12, 16, 24||||||
799456|NCT00947531|Secondary|Change From Baseline in ADAS-COG+ (Alzheimer’s Disease Assessment Scale Cognitive Subpart)|The modified Alzheimer’s Disease Assessment Scale – Cognitive (ADAS-COG+) is a psychometric instrument used by a neuropsychologist that evaluates memory, attention, reasoning, language, orientation and praxis.|week 4, 12, 16||||||
799457|NCT00947531|Secondary|Adverse Experiences, Vital Signs, Physical and Neurological Examinations, Laboratory Tests (Hematology, Clinical Chemistry, Urinalysis ), ECG (Electrocardiogram)||Baseline, week 4, 12, 16, 24||09/2009||||
799458|NCT00947531|Primary|CIBIC+ (Clinicians Interview-based Impression of Change) Score at Week 24||week 24||09/2009||||
799459|NCT00947531|Primary|Change From Baseline in ADAS-cog+ (Alzheimer's Disease Assesment Scale - Cognitive Subpart) at Week 24|The ADAS-COG+ is a psychometric instrument used to evaluate memory, attention, reasoning, language, orientation and praxis. The score ranges from 0 to 85 with 85 being the worst score. A negative change indicates cognitive improvement.|baseline and week 24|The primary and confirmatory analysis is based on the ITT analysis set. The LOCF method is applied to account for missing data. The ITT analysis set consists of all randomized patients, who received at least one dose of study medication and had a baseline and at least one post-baseline assessment for both primary efficacy measures.||points on a scale||Standard Deviation|Mean
799460|NCT00947544|Secondary|Quality of Life Assessed by the SF-15 Questionnaire|"change from baseline to Month 12.
The SF 15 questionnaire consists of 15 questions that assess the following:
Physical functioning (5 questions)
Emotional functioning (4 questions)
Social functioning (3 questions)
School functioning (3 questions) Items were scored on a 5-point Likert scale from 0 (never) to 4 (almost always) or a 3-point scale (0 [not at all], 2 [sometimes], or 4 [a lot] for the young child self-report). Items were reverse-scored and linearly transformed to a 0–100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score was 0-100 scale (averaged from each functional areas). In the 0-100 scale, 0 is the worst score and 100 is best score.
Improved quality of life was shown by increased total score from baseline to Month 12."|1 year|Patients who completed SF-15 at baseline and Month 12 both time in the safety extension period.||score on a scale|total score from SF-15 report|Standard Deviation|Mean
799461|NCT00947544|Secondary|Plasma PAGN AUC0-24 Values on NaPBA vs. HPN-100 on on the Last Day of Treatment With Each Drug|blood samples were collected at pre-dose, 4, 8, 12, 16, 20, and 24 hour post dose on both Day 7 (NaPBA) and Day 14 (HPN-100).|Day 7 (NaPBA) and Day 14 (HPN-100)|||μg*h/mL AUC 0-24||Standard Deviation|Mean
799462|NCT00947544|Secondary|Plasma PBA (Phenylbutyrate) AUC0-24 Values on NaPBA vs. HPN-100 on on the Last Day of Treatment With Each Drug|blood samples were collected at pre-dose, 4, 8, 12, 16, 20, and 24 hour post dose on both Day 7 (NaPBA) and Day 14 (HPN-100).|Day 7 (NaPBA) and Day 14 (HPN-100)|||µg*h/ml AUC 0-24||Standard Deviation|Mean
799463|NCT00947544|Secondary|Plasma PAA (Phenylacetate) AUC0-24 Values on NaPBA vs. HPN-100 on on the Last Day of Treatment With Each Drug|blood samples were collected at pre-dose, 4, 8, 12, 16, 20, and 24 hour post dose on both Day 7 (NaPBA) and Day 14 (HPN-100).|Day 7 (NaPBA) and Day 14 (HPN-100)|||μg•h/mL AUC 0-24||Standard Deviation|Mean
799464|NCT00947544|Secondary|Urinary PAGN 24-hour Excretion Values on NaPBA vs. HPN-100 (Switch Over)|Urinary PAGN (phenylacetylglutamine) 24-hour excretion. Urine was collect during 0-12 hrs and 12-24 hrs.|Day 7 (NaPBA) and Day 14 (HPN-100)|||μg||Standard Deviation|Mean
799465|NCT00947544|Secondary|Rate (Percentage) of Ammonia Values Above Upper Limit of Normal (ULN) on NaPBA vs. HPN-100|blood samples were collected at pre-dose, 4, 8, 12, 16, 20, and 24 hour post dose on both Day 7 (NaPBA) and Day 14 (HPN-100).|Day 7 (NaPBA) and Day 14 (HPN-100)|||percentage of sample|number of blood sample||Number
799466|NCT00947544|Secondary|Average Ammonia Values on NaPBA vs. HPN-100 on the Last Day of Treatment With Each Drug (Switch Over)|blood samples were collected at pre-dose, 4, 8, 12, 16, 20, and 24 hour post dose on both Day 7 (NaPBA) and Day 14 (HPN-100).|Day 7 (NaPBA) and Day 14 (HPN-100)|||µmol/L||Standard Deviation|Mean
799467|NCT00947544|Secondary|NH3 Cmax on NaPBA vs. HPN-100 on the Last Day of Treatment With Each Drug|blood samples were collected at pre-dose, 4, 8, 12, 16, 20, and 24 hour post dose on both Day 7 (NaPBA) and Day 14 (HPN-100).|Day 7 (NaPBA) and Day 14 (HPN-100)|||μmol/L||Standard Deviation|Mean
799468|NCT00947544|Secondary|Blood Ammonia Control|To evaluate control of blood ammonia by HPN-100 compared with NaPBA in pediatric patients with UCDs.|Day 7 (NaPBA) and Day 14 (HPN-100)|||μmol∙h/L||Standard Deviation|Mean
799469|NCT00947544|Secondary|Number and Causes of Hyperammonemic Events (Safety Extension)|"Number of Subjects with at Least One Hyperammonemic Crisis.
Hyperammonemic crisis is defined as follows:
• Clinical symptoms associated with ammonia of ≥ 100 µmol/L"|1 year|||participants|||Number
799470|NCT00947544|Primary|Rate of Adverse Events During the Switchover Part of the Study Rate of Adverse Events (Number of Participants Showing Adverse Events)|To evaluate the safety and PK characteristics of HPN-100 compared with sodium phenylbutyrate (NaPBA) in pediatric patients with urea cycle disorders (UCDs)|1 week on each treatment for a total of 2 week.|||participants|||Number
799471|NCT00947661|Primary|Change in Intraocular Pressure From Baseline to Week 12|95% CI for the difference between treatment groups in estimated mean change from baseline was computed for each a total of 12 time points (for the reduction in intraocular pressure from baseline to Week 12)|12 weeks|Intent to treat population without LOCF||mm Hg||Standard Error|Least Squares Mean
799472|NCT00947752|Secondary|Degree of Pain Within 5 Mins After Injection|A visual analog scale (VAS) was used for subjective characteristics that cannot be directly measured. Respondents specified their level of agreement to a statement by indicating a position along a continuous line between two end-points. The VAS scale used 0 mm to represent “no pain” and up to 100 mm to represent “worst possible pain;” subjects drew a continuous line to represent their level of pain.|5 weeks of injections|Of the 147 subjects to be analyzed, 3 were excluded for discontinuations due to withdraw of consent.||Scores on a scale||Standard Deviation|Mean
799473|NCT00947752|Primary|Subject-reported Pain Associated Immediately After Each Injection|A visual analog scale (VAS) was used for subjective characteristics that cannot be directly measured. Respondents specified their level of agreement to a statement by indicating a position along a continuous line between two end-points. The VAS scale used 0 mm to represent “no pain” and up to 100 mm to represent “worst possible pain;” subjects drew a continuous line to represent their level of pain.|5 weeks of injections|Of the 147 subjects to be analyzed, 3 were excluded for discontinuations due to withdraw of consent.||Scores on a scale||Standard Deviation|Mean
799474|NCT00947765|Primary|Pain(at 6 Months): Nirschl Staging|"NIRSCHL STAGING:
phase1: mild pain with exercise; resolves within 24 hours phase2: pain after exercise; exceeds 48 hours phase3: pain with exercise; does not alter activity phase4: pain with exercise; alters activity phase5: pain with heavy activities of daily living phase6: pain with light activities of daily living; intermittent pain at rest phase7: constant pain at rest; disrupts sleeps
No pain______1 ______ 2______ 3_______4______ 5______ 6 _____ 7 worst pain"|6 months|||Units on a scale||Standard Deviation|Mean
799475|NCT00947765|Primary|Pain(at 6 Months): Visual Analogue Scale|"VISUAL ANALOGUE SCALE:
Pain of the participants will be assessed by most widely used and accepted “visual analogue scale”. It consists of a 10 centimeter line marked at one end with “no pain” and at other end with “worst pain ever”. Participant is asked to indicate where on the line he or she rates the pain on the day of presentation, 1, 4, 12weeks and 6 month of follow-ups. Numerical valve is then given to it simply by measuring length between “no pain” to patients mark.
No pain____1 ___ 2 ___ 3 ___ 4 ___ 5 ___ 6 ___ 7 ___ 8 ___ 9 ___ 10 worst pain ever."|6 months|||Units on a scale||Standard Deviation|Mean
799476|NCT00947765|Primary|Pain(at 12 Weeks): Nirschl Staging|"NIRSCHL STAGING:
phase1: mild pain with exercise; resolves within 24 hours phase2: pain after exercise; exceeds 48 hours phase3: pain with exercise; does not alter activity phase4: pain with exercise; alters activity phase5: pain with heavy activities of daily living phase6: pain with light activities of daily living; intermittent pain at rest phase7: constant pain at rest; disrupts sleeps
No pain______1 ______ 2______ 3_______4______ 5______ 6 _____ 7 worst pain"|12 weeks|||Units on a scale||Standard Deviation|Mean
799477|NCT00947765|Primary|Pain(at 12 Weeks): Visual Analogue Scale|"VISUAL ANALOGUE SCALE:
Pain of the participants will be assessed by most widely used and accepted “visual analogue scale”. It consists of a 10 centimeter line marked at one end with “no pain” and at other end with “worst pain ever”. Participant is asked to indicate where on the line he or she rates the pain on the day of presentation, 1, 4, 12weeks and 6 month of follow-ups. Numerical valve is then given to it simply by measuring length between “no pain” to patients mark.
No pain____1 ___ 2 ___ 3 ___ 4 ___ 5 ___ 6 ___ 7 ___ 8 ___ 9 ___ 10 worst pain ever."|12 weeks|||Units on a scale||Standard Deviation|Mean
799478|NCT00947765|Primary|Pain(at 4 Weeks): Nirschl Staging|"NIRSCHL STAGING:
phase1: mild pain with exercise; resolves within 24 hours phase2: pain after exercise; exceeds 48 hours phase3: pain with exercise; does not alter activity phase4: pain with exercise; alters activity phase5: pain with heavy activities of daily living phase6: pain with light activities of daily living; intermittent pain at rest phase7: constant pain at rest; disrupts sleeps
No pain______1 ______ 2______ 3_______4______ 5______ 6 _____ 7 worst pain"|4 weeks|||Units on a scale||Standard Deviation|Mean
799479|NCT00947765|Primary|Pain(at 4 Weeks): Visual Analogue Scale|"VISUAL ANALOGUE SCALE:
Pain of the participants will be assessed by most widely used and accepted “visual analogue scale”. It consists of a 10 centimeter line marked at one end with “no pain” and at other end with “worst pain ever”. Participant is asked to indicate where on the line he or she rates the pain on the day of presentation, 1, 4, 12weeks and 6 month of follow-ups. Numerical valve is then given to it simply by measuring length between “no pain” to patients mark.
No pain____1 ___ 2 ___ 3 ___ 4 ___ 5 ___ 6 ___ 7 ___ 8 ___ 9 ___ 10 worst pain ever."|4 weeks|||Units on a scale||Standard Deviation|Mean
799480|NCT00947765|Primary|Pain(at 1 Week): Nirschl Staging (0 to 7)|"NIRSCHL STAGING:
phase1: mild pain with exercise; resolves within 24 hours phase2: pain after exercise; exceeds 48 hours phase3: pain with exercise; does not alter activity phase4: pain with exercise; alters activity phase5: pain with heavy activities of daily living phase6: pain with light activities of daily living; intermittent pain at rest phase7: constant pain at rest; disrupts sleeps
No pain______1 ______ 2______ 3_______4______ 5______ 6 _____ 7 worst pain"|1 week|Participants were clinically examined for the treatment response i.e., decrease in pain.||Units on a scale||Standard Deviation|Mean
799481|NCT00947765|Primary|Pain (at 1 Week): Visual Analogue Scale(0 to 10)|"VISUAL ANALOGUE SCALE:
Pain of the participants will be assessed by most widely used and accepted “visual analogue scale”. It consists of a 10 centimeter line marked at one end with “no pain” and at other end with “worst pain ever”. Participant is asked to indicate where on the line he or she rates the pain on the day of presentation, 1, 4, 12weeks and 6 month of follow-ups. Numerical valve is then given to it simply by measuring length between “no pain” to patients mark.
No pain____1___2___3___4___5___6___7___8___9___10 worst pain ever."|1 week|Participants were clinically examined for the treatment response i.e., decrease in pain.||Units on a scale||Standard Deviation|Mean
799482|NCT00947791|Secondary|Systematic Assessment for Treatment Emergent Effects (SAFTEE)||4 hrs post-infusion compared to baseline|Based on confidentiality concerns, 0 participants analyzed.|||||
799483|NCT00947791|Secondary|Clinician-Administered Dissociative States Scale (CADSS)||4 hrs post-infusion compared to baseline|Based on confidentiality concerns, 0 participants analyzed.|||||
799484|NCT00947791|Secondary|Brief Psychiatric Rating Scale (BPRS)||4 hrs post-infusion compared to baseline|Based on confidentiality concerns, 0 participants analyzed.|||||
799488|NCT00947856|Secondary|Incidence of Antitherapeutic Antibodies|Counts of participants with anti-brentuximab vedotin antibodies at any time during extension treatment on Study SGN35-006 or number of retreatment experiences with anti-brentuximab vedotin antibodies at any time during retreatment|Up to 39 months|Any patient who received extension treatment or retreatment and had baseline and postbaseline sample results; 1 HL patient on the retreatment arm did not have postbaseline sample results and 3 ALCL patients on the retreatment arm were retreated more than once and had samples.||participants or experiences|Retreatment or Extension Txt Experiences||Number
799489|NCT00947856|Secondary|Overall Survival|Overall survival for both extension and retreatment arms, defined as time from start of study treatment to date of death due to any cause|Up to approximately 41 months|Patients who received treatment on the extension arm, and patients who received retreatment and had postbaseline response results; 1 HL patient on the retreatment arm did not have postbaseline response results and 3 ALCL patients on the retreatment arm were retreated more than once.||months|Retreatment or Extension Trt Experiences|95% Confidence Interval|Median
799490|NCT00947856|Secondary|Progression-free Survival by Kaplan-Meier Analysis|Progression-free survival, defined as time from start of study treatment in the retreatment arm to disease progression per investigator or death due to any cause|Up to approximately 29 months|Any patient who received retreatment and had postbaseline response results; 1 HL patient did not have postbaseline response results and 3 ALCL patients were retreated more than once.||months|Retreatment Experiences|95% Confidence Interval|Median
799491|NCT00947856|Secondary|Duration of Objective Response by Kaplan-Meier Analysis|Duration of objective response (CR + PR) on retreatment, defined as time of initial response until disease progression or death|Up to 38 months|Participants with objective response among those who received retreatment||months|Retreatment Experiences|95% Confidence Interval|Median
799492|NCT00947856|Primary|Laboratory Abnormalities >/= Grade 3|Counts of study participants with post-baseline laboratory abnormalities of Grade 3 or greater per NCI CTCAE version 3.0. Participants with multiple occurrences of a laboratory abnormality within a category are counted once in that category.|Up to 39 months|All participants who received treatment||participants|||Number
799493|NCT00947856|Primary|Adverse Events by Severity, Seriousness, and Relationship to Treatment|Counts of participants who had adverse events or treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose on SGN35-006). Serious adverse events are reported from the time of informed consent. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death). Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an adverse event within a category are counted once within the category.|up to 39 months|All participants who received treatment||participants|||Number
799494|NCT00947856|Primary|Objective Response Rate by Investigator|Percentage of participants in the retreatment arm who achieved a best response of complete remission (CR, disappearance of all evidence of disease) or partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.|Up to approximately 38 months|Any patient who received retreatment and had postbaseline response results; 1 HL patient did not have postbaseline response results and 3 ALCL patients were retreated more than once.||percentage of retreatment experiences|Retreatment Experiences|95% Confidence Interval|Number
799495|NCT00947882|Secondary|Mean Change in Maximum Urinary Flow (Qmax)|Urinary flow rate (mL/second) was measured using uroflowmetry performed according to the recommendation from the International Continence Society (ICS).|From Baseline to Month 3 and Month 6 after Dosing|"FAS. The as planned patient allocation for treatment groups was used (please refer to the Baseline Characteristics section)."||percentage change from baseline||Standard Deviation|Mean
799496|NCT00947882|Secondary|Mean Percentage Change in Total Prostate Volume (TPV)|TPV was measured directly by standardised trans-rectal ultrasound (TRUS).|From Baseline to Month 3 and Month 6 after Dosing|"FAS. The as planned patient allocation for treatment groups was used (please refer to the Baseline Characteristics section)."||percentage change from baseline||Standard Deviation|Mean
799497|NCT00947882|Secondary|Odds Ratio (as Compared to Placebo) of Treatment Response in IPSS|A 3-point reduction in IPSS score compared to baseline is defined as a clinically meaningful treatment response. Percentage of participants who met criteria for a clinically meaningful treatment response and odds ratios of treatment responses between each degarelix dose group and the placebo group are presented.|At Month 3, Month 4, Month 5 and Month 6 after Dosing|"FAS. The as planned patient allocation for treatment groups was used (please refer to the Baseline Characteristics section)."||percentage of participants|||Number
799498|NCT00947882|Secondary|Mean Change in IPSS|This secondary outcome measure was used to assess the maintained dose-response of the 3 degarelix dose groups in terms of severity of LUTS and progress of the disease process, versus the placebo group.|From Baseline to Month 4, Month 5 and Month 6 after Dosing|"FAS. The as planned patient allocation for treatment groups was used (please refer to the Baseline Characteristics section)."||percentage change from baseline||Standard Deviation|Mean
799499|NCT00947882|Primary|Mean Change in International Prostate Symptom Score (IPSS)|"This outcome measure was used to assess the dose-response of the 3 degarelix dose groups in terms of severity of lower urinary tract symptoms (LUTS) and progress of the disease process, versus the placebo group. One treatment month equals 28 days.
The IPSS questionnaire is a tool commonly used to assess the severity of LUTS, and to monitor the progress of the symptoms during treatment. It contains 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5 (i.e. minimum total score is 0 and the maximum score is 35), where 0 corresponds to a response of not at all for the first six symptoms and none for nocturia, and 5 corresponds to a response of almost always for the first six symptoms and 5 times or more for nocturia. The IPSS also includes a question to evaluate a patient's quality of life in relation to his urinary symptoms, which is not included in the total IPSS score."|From Baseline to Month 3 after Dosing|"FAS. The as planned patient allocation for treatment groups was used in the efficacy analyses (please refer to the Baseline Characteristics section)."||percentage change from baseline||Standard Deviation|Mean
799500|NCT00948064|Primary|Survival at Day 60|Assessment of survival for outcome done on 60 days following therapy and includes participants alive for at least 60 days. Survival is calculated from start of therapy until death from any cause.|Phase II, Baseline to 60 days following first treatment.|Of the 79 participants enrolled, 78 were evaluable and 1 participant withdrew from study.||participants|||Number
799501|NCT00948064|Primary|Response Rate|Number of participants with Complete Response (CR) in AML requiring disappearance of all signs and symptoms related to disease, normalization of peripheral counts (absolute neutrophil count 10^9/L or more, platelet count 100 x 10^9/L or more), and a marrow with 5% or less marrow blasts; a hematologic improvement (HI) defined as a CR except for a platelet count increase by 50% to above 30 x 10^9/L. For MDS, the International Working Group criteria used to assess response.|12-18 Months|Out of 79 participants enrolled in Phase II, 2 participants were not evaluable - 1 participant was removed from study per treating physician discretion and the other was removed per participant's request.||participants|||Number
799502|NCT00948064|Primary|Survival at Day 60|Assessment of survival for outcome done on 60 days following therapy and includes participants alive for at least 60 days. Survival is calculated from start of therapy until death from any cause.|Phase I, Baseline to 60 days following first treatment.|Of the 31 enrolled participants, 30 were evaluable and 1 participant never received treatment.||participants|||Number
799503|NCT00948090|Secondary|Overall Response Rate|The overall response status is complete response and not complete response (partial remission, primary refractory/primary induction failure, stable disease, progressive disease, and relapse) at Baseline and each of the scheduled follow-up time points.|Baseline, Day 100, Month 6, 12, 24, Early termination and End of Trial (within 30 days of the trial termination)|Participants receiving at least 1 PK-directed IV busulfan dose followed by autologous hematopoietic stem cell transplant are included in the ITT data set. Four participants (of 207) did not continue to the conditioning regimen after receiving the PK test dose and were excluded from ITT data set.||Participants|||Number
799504|NCT00948090|Secondary|Number of Transplant-related Death Events Until Day 100.|Transplant-related mortality was defined as death due to any cause other than disease relapse/progression up until Day 100.|Day 100|Participants receiving at least 1 PK-directed IV busulfan dose followed by autologous hematopoietic stem cell transplant are included in the ITT data set. Four participants (of 207) did not continue to the conditioning regimen after receiving the PK test dose and were excluded from ITT data set.||Transplant-related death|||Number
799505|NCT00948090|Secondary|Number of Death Events in 2 Years.|The time of overall survival was defined as the time from transplantation to death of all causes.|2 years|Participants receiving at least 1 PK-directed IV busulfan dose followed by autologous hematopoietic stem cell transplant are included in the ITT data set. Four participants (of 207) did not continue to the conditioning regimen after receiving the PK test dose and were excluded from ITT data set.||Deaths|||Number
799506|NCT00948090|Primary|Number of Progression Events in 2 Years.|The time of Progression-Free Survival (PFS) was defined as the time from transplantation to the occurrence of the event that was death or first recurrence of progressive disease.|2 years|Participants receiving at least 1 PK-directed IV busulfan dose followed by autologous hematopoietic stem cell transplant are included in the Intent-to-treat (ITT) data set. Four participants (of 207) did not continue to the conditioning regimen after receiving the PK test dose and were excluded from ITT data set.||Event|||Number
799507|NCT00948155|Secondary|Subjective Measures to Assess Smoking Urges|Craving for cigarettes was assessed with the 32-item Questionnaire of Smoking Urges (QSU) during each study visit. In order to calculate the QSU measure, each item is rated on a Likert-type scale from 1 (strongly disagree) to 7 (strongly agree). The values are then summed to create a single total score. Well validated 2 factor subscale scores were also created by summing the item scores for the 2 factors: Factor 1 reflects the desire to smoke for pleasure and Factor 2 reflects urges to smoke to relieve withdrawal-related negative affect. Internal consistency for each scale across all time points was high (Cronbach’s α > 0.95, 0.85, and 0.95 for Factor 1, Factor 2, and QSU total, respectively). Scale range is 1-7 where 1 is low urge to smoke and 7 represents high urge to smoke. Data was collected at each time point but outcome measure of interest is end of period.|Days 21 of each of the two 21-day study periods, range 1(low)-7(high)|Subjects who completed both 21 day placebo and drug periods.||units on a scale||Standard Deviation|Mean
799508|NCT00948155|Secondary|Carbon Monoxide Levels|Exhaled breath carbon monoxide levels collected at Day 1 and Day 21 sessions. Alveolar carbon monoxide is a validated assessment of smoke exposure.|Samples from Day 1 and Day 21 of two 21 day Periods|Subjects who completed both 21 day placebo and drug periods.||parts per million||Standard Error|Mean
799509|NCT00948155|Secondary|Cotinine Levels From Urine Samples|Cotinine levels from urine samples collected at Day 1 and Day 21.|Samples from Day 1 and Day 21 of two 21 day Periods|Subjects who completed both 21 day placebo and drug periods.||micromolar||Standard Deviation|Mean
799510|NCT00948155|Secondary|Nicotine Levels From Urine Samples|Nicotine levels from urine samples collected at Day 1 and Day 21.|Samples from Day 1 and Day 21 of two 21 day Periods|Subjects who completed both 21 day placebo and drug periods.||micromolar||Standard Deviation|Mean
799511|NCT00948155|Secondary|Total Nicotine Metabolites From Urine Samples|Total urinary metabolites from urine samples collected at Day 1 and Day 21|Samples from Day 1 and Day 21 of two 21 day Periods|Subjects who completed both 21 day placebo and drug periods.||micromolar||Standard Deviation|Mean
799512|NCT00948155|Primary|Daily Cigarette Consumption|Average of the number of cigarettes smoked per day|Two 21 day study periods|||number of cigarettes smoked per day||Standard Error|Mean
799513|NCT00948155|Primary|The Number of Choices of a Nicotine Containing Cigarette Compared to a Non-nicotine Cigarette.|Participants were given 4 puff choices (between a nicotine containing and de-nicotinized cigarette) on 6 study visits, for a total of 24 choices. Number of puffs reported is average across both study periods.|Days 1, 7, 21 of each of two 21 day study periods|All participants who completed the task were included in the analysis||number of puffs chosen of a maximum 24||Standard Error|Mean
799514|NCT00948155|Primary|Smoking Topography: Total Puff Volume|Total puff volume was created by summing all of the puffs from the cigarette smoked in the lab at each time point (each lab visit). This value represents the total volume of smoke extracted from a single cigarette and it a standard measure of smoking behavior. A total puff volume represents the total smoking volume from a cigarette. Values are reported in milliliters. Value of interest is the average puff volume across all sessions for all participants in a group and is reported as a key measure of smoking behavior. Analyses were repeated measures analysis of variance where individual, time and drug were within factors.|Days 1-21 of each of 2 study periods|All those participants who completed both study periods were included in the analysis.||milliliters||Standard Error|Mean
799515|NCT00948246|Secondary|Change in Weight|Change in weight (in kilograms) at baseline to 12 months|12 months|||pounds||95% Confidence Interval|Mean
799517|NCT00948246|Secondary|% Excess Weight Loss|Percent excess weight loss was defined as weight loss divided by excess weight multiplied by 100, where weight loss was equal to baseline weight minus follow-up weight, and excess weight was equal to baseline weight minus ideal weight.|12 months|||percentage of excess weight loss||95% Confidence Interval|Mean
799518|NCT00948246|Primary|Feasibility and Ease of Implantation|"Percent of subjects whose device implantation was rated by the surgeon as a 1 or 2 on a 5-point scale, where 1 is very easy and 5 is impossible."|< 1day|Intent-to-treat||percentage of subjects|||Number
799519|NCT00953849|Primary|Change in IL-6 Levels.|Change in levels of immune inhibitory/inflammatory mediator IL-6 in tumor tissue.|baseline and 3 weeks|Patients with head and neck squamous cell carcinoma.||pg/100 gm protein||Standard Error|Mean
799520|NCT00953849|Primary|Change in GM-CSF|Change in GM-CSF stimulatory cytokine levels within tumor tissue.|baseline and 3 weeks|Patients with head and neck squamous cell carcinoma.||pg/100 gm protein||Standard Error|Mean
799521|NCT00953849|Primary|Change in IFN-gamma Levels|Change in IFN-gamma stimulatory cytokine levels within tumor tissue.|baseline and 3 weeks|Patients with head and neck squamous cell carcinoma.||pg/100 gm protein||Standard Error|Mean
799522|NCT00953849|Primary|Change in IL-2 Levels|Change in IL-2 stimulatory cytokine levels within tumor tissue.|baseline and 3 weeks|Patients with head and neck squamous cell carcinoma.||pg/100 gm protein||Standard Error|Mean
799523|NCT00953862|Secondary|Change in Clinical Global Impression-- Severity of Illness Score|The CGI-S (Clinical Global Impression-- Severity of Illness) scale is a single-item rating scale of the clinician's assessment of the global severity of ADHD symptoms in relation to the clinician's total experience with ADHD patients. Severity is rated on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill).|Baseline and week 10 of treatment|Those treated with atomoxetine who were not discontinued due to receiving less than 2 weeks of treatment||units on a scale||Standard Deviation|Mean
799524|NCT00953862|Secondary|Change in Adult ADHD Symptom Rating Scale v1.1 Symptom Checklist Score|The ASRS (Adult ADHD Symptom Rating Scale) v1.1 Symptom Checklist is an 18-item scale developed by the workgroup on Adult ADHD for the World Health Organization designed to assess the frequency of ADHD symptoms on a 0-4 scale (0 = never, 1 = rarely, 2 = sometimes, 3= often, and 4 = very often, minimum total summed score of 0 and maximum total summed score of 72, higher score is more impairment).|Baseline and week 10 of treatment|Those treated with atomoxetine who were not discontinued due to receiving less than 2 weeks of treatment||units on a scale||Standard Deviation|Mean
799525|NCT00953862|Primary|Change in Adult ADHD Investigator Symptom Rating Scale Score|The AISRS (Adult ADHD Investigator Symptom Rating Scale) consists 18-items that directly correspond to the 18 DSM-IV symptoms of ADHD. Each item is scored on a 4-point scale (0 = none; 1 = mild; 2 = moderate; and 3 = severe, higher score is more impaired). The total summed score was at minimum 0 and at maximum 54 (the higher the score the more severe the symptomatology).|Baseline and week 10 of treatment|Those treated with atomoxetine who were not discontinued due to receiving less than 2 weeks of treatment||units on a scale||Standard Deviation|Mean
799526|NCT00953927|Secondary|To Evaluate the QuantiFERON Conversion Rate at Final Study Assessment in MVA85A/AERAS-485 Recipients Compared to Controls in Infants Without a Diagnosis of Tuberculosis During the Trial.|The number (percentage) of infants with QuantiFERON conversions at any time on the study were summarized by treatment group.|15 to 36 months post-vaccination|Per protocol population who were quantiferon negative at baseline.||participants|||Number
799527|NCT00953927|Secondary|To Discover Correlates of Protection From Tuberculosis in Infants Vaccinated With MVA85A/AERAS-485.|Investigations for determining correlates of immune protection to TB will not be completed as planned because the study did not show TB protection in MVA85A/AERAS-485 recipients.|15 to 36 months post-vaccination||||||
799528|NCT00953927|Secondary|To Evaluate the Immunogenicity of the MVA85A/AERAS-485 Vaccine Compared to Controls as Described by the University of Capetown (UCT) Whole Blood Intracellular Cytokine Assay.|Frequencies of CD4 and CD8 T cells expressing cytokines (IFN-γ, IL-2 and TNF-α) following stimulation of whole blood with an Ag85A peptide pool were also measured by flow cytometry for a subset of infants.|28 days post-vaccination|Pre-specified population subset||percentage of cytokine expressing cells||95% Confidence Interval|Median
799529|NCT00953927|Secondary|To Evaluate the Immunogenicity of the MVA85A/AERAS-485 Vaccine Compared to Controls as Described by the ex Vivo Enzyme Linked Immunospot (ELISPOT) Test Used in Previous MVA85A/AERAS-485 Human Trials.|An ex vivo IFN-γ ELISPOT assay was used to assess specific T cell responses to an Ag85A peptide pool for a subset of infants.|7 days post-vaccination|Pre-specified population subset||SFC per million PBMCs||95% Confidence Interval|Median
799530|NCT00953927|Secondary|To Evaluate the Immunogenicity of the MVA85A/AERAS-485 Vaccine Compared to Controls as Described by Flow Cytometric Intracellular Cytokine Staining of CD4 and CD8 T Cells.|Intracellular cytokine staining (ICS) assay immune response was expressed as the percentage of cluster of differentiation 4 (CD4) and cluster of differentiation 8 (CD8) T cells producing any one of three cytokines (IFN-γ, TNF-α, or IL-2) or any combination of the three cytokines simultaneously after stimulation with an Ag85A peptide pool on a subset of infants.|28 days post-vaccination|Pre-specified population subset||percentage of cytokine expressing cells||95% Confidence Interval|Median
799531|NCT00953927|Secondary|To Evaluate the Efficacy of the MVA85A/AERAS-485 Vaccine Compared to Controls in Prevention of Tuberculosis Using an Endpoint Derived From Epidemiological Cohort Surveys in BCG Vaccinated Infants.|The number (percentage) of subjects with a diagnosis of tuberculosis based on clinically-derived tuberculosis (TB) diagnostic criteria were summarized by treatment group for all subjects.|15 to 36 months post-vaccination|Per protocol population||participants with a diagnosis of TB|||Number
799532|NCT00953927|Primary|To Evaluate the Safety Profile of MVA85A/AERAS-485 in Bacillus Calmette-Guerin (BCG) -Vaccinated, HIV-negative Infants.|Adverse events (AE) were collected for 28 days after vaccination. The subject's parent or guardian recorded information regarding occurrences of solicited adverse events in diary cards through 7 days after vaccination. Serious adverse events (SAE) were collected from the time of study vaccine dosing throughout the entire study. A safety cohort (the first 330 infants enrolled) also had serum chemistry and hematology testing up to 28 days post-vaccination.|AEs recorded 28 days post-vaccination; SAEs recorded for entire study period.|All subjects vaccinated.||percentage of all subjects vaccinated||95% Confidence Interval|Number
802164|NCT00980642|Secondary|Sensitivity for Detection of Hypothermia|Hypothermia is defined as a temperature < 36 Celsius degree|From anesthesia induction to the end of surgery|||percent of hypothermias||95% Confidence Interval|Number
799533|NCT00954109|Primary|Blood Flow in Response to Oral Glucose Tolerance Tests|Blood flow response in the femoral artery measured by Doppler ultrasound during and oral glucose tolerance test. Data are represented as % change in blood flow during the oral glucose tolerance at 60 minutes vs. 0 minutes (prior to drinking the glucose)|pre and 24 hours post 5-7 days of exercise|||percentage change||Standard Error|Mean
799534|NCT00954109|Primary|Insulin Sensitivity After 5-7 Days of Exercise|Insulin sensitivity measured during an oral glucose tolerance test measured by the Matsuda Index. Matsuda insulin sensitivity index= 10000/square root of [(fasting glucose × fasting insulin) × (mean glucose × mean insulin during oral glucose tolerance test).|baseline and 24h after 5-7 days of exercise|||index score||Standard Error|Mean
799535|NCT00954122|Secondary|Change of the Positive and Negative Syndrome Scale Excited Component (PANSS-EC) Score Compared From Baseline to Day 21.|"Excited Component was used to evaluate the control of agitation and aggression in patients with schizophrenia.
Difference in mean score at baseline and day 21 is used to assess the improvement. It is shown by reduction in mean score and confirmed by p value lower than 0,05.
Positive and Negative Syndrome Scale Excited Component (PANSS-EC) is a subscale score which is calculated by adding together the following item scores: excitement (positive subscale item 4); hostility (positive subscale item 7); tension (general subscale item 4); uncooperativeness (general subscale item 8); poor impulse control (general subscale item 14).
This is rated on a 7-point Likert scale from 'absent' to 'extremely severe' (score range 5 to 35 points; mean scores = 20 points clinically corresponds to severe agitation)."|Baseline and Day 21|ITT population, which comprise of patients who have baseline and at least ONE (1) set of post-baseline PANSS assessments. No imputation on Outcome Measurement.||Scores on a scale||Standard Deviation|Mean
799536|NCT00954122|Secondary|Change From Baseline in Absolute Clinical Global Impression-Improvement (CGI-I) Scale|"Clinical Global Impression, Improvement (CGI-I) is a single-item (7-point) scale that evaluates the overall improvement in the subject’s mental. A reduction in score indicates an improvement in the subject’s condition. This assessment is based on the improvement since initiation of the study treatment.
Change in CGI-I score is analyzed by comparing CSI-score at the relevant time point to the baseline CGI-I score."|Baseline and Day 21|ITT population, which comprise of patients who have baseline and at least ONE (1) set of post-baseline PANSS (Positive and Negative Syndrome Scale) assessments. No imputation on CGI-I score.||Scores on a scale||Standard Deviation|Mean
799537|NCT00954122|Secondary|Change From Baseline in Clinical Global Impression-Severity Scale (CGI-S)|"Clinical Global Impression, Severity (CGI-S) is a single-item (7-point) scale that evaluates the overall severity of the subject’s mental illness. A reduction in score indicates an improvement in the subject’s condition. The CGI-S assessment should be based upon the subject’s symptoms during the previous week.
Change from baseline in CGI-S score is calculated by subtracting the CGI-S score at baseline from the CGI-S score at the relevant time point."|Baseline and Day 21|ITT population, which comprise of patients who have baseline and at least ONE (1) set of post-baseline PANSS (Positive and Negative Syndrome Scale) assessments. No imputation on CGI-S score.||scores on a scale||Standard Deviation|Mean
799538|NCT00954122|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score|Positive and Negative Syndrome Scale (PANSS) total score is a medical scale used for measuring symptom severity of patients with schizophrenia. It is calculated by adding together PANSS-Positive (minimum score = 7, maximum score = 49, PANSS-Negative (minimum score = 7, maximum score = 49), PANSS-General Psychopathological (PANSS-G) subscale scores (minimum score = 16, maximum score = 112), supplementary subscale item scores. The minimum is 30, maximum is 210. Total PANSS score classification: Mildly ill 58- 74, Moderately ill 75-94, Markly ill 95- 115, Severely ill >116.|Baseline and Day 21|ITT population, which comprise of patients who have baseline and at least ONE (1) set of post-baseline PANSS assessments. No imputation on PANSS Total score.||Scores on a scale||Standard Deviation|Mean
799539|NCT00954122|Secondary|Change From Baseline to Final Visit at Day 21 in PANSS Negative, General Psychopathological Scores|Negative scale includes 7 items (Blunted affect, Emotional withdrawal, Poor rapport, Passive/apathetic social withdrawal, Difficulty in abstract thinking, Lack of spontaneity and flow of conversation, Stereotyped thinking)and is calculated by adding the negative subscale item scores. Minimum score is 7, maximum score is 49. General Psychopathology scale includes 16 Items (Somatic concern, Anxiety, Guilt feelings, Tension, Mannerisms and posturing, Depression, Motor retardation, Uncooperativeness, Unusual thought content, Disorientation, Poor attention, Lack of judgment and insight, Disturbance of volition, Poor impulse control, Preoccupation, Active social avoidance). Minimum score is 16, maximum score is 112. The higher score- the worse outcome. Measure includes PANSS-Negative (range 8-37), PANSS-General Psychopathological (PANSS-G)(range 17-70), total PANSS score (range 37-143), PANSS aggression, hostility and depression cluster scores (range 4-19).|Baseline and Day 21|ITT population, which comprise of patients who have baseline and at least ONE (1) set of post-baseline PANSS assessments. No imputation on PANSS Positive score.||Scores on a scale||Standard Deviation|Mean
799540|NCT00954122|Secondary|Change From Baseline to Final Visit at Day 21 in PANSS Positive, General Psychopathological Scores.|"Positive scale includes 7 Items (Delusions, Conceptual disorganization, Hallucinations, Hyperactivity, Grandiosity, Suspiciousness/persecution, Hostility)and is calculated by adding the positive subscale item scores. Minimum score is 7, maximum score is 49. General Psychopathology scale:16 items (Somatic concern, Anxiety, Guilt feelings, Tension, Mannerisms and posturing, Depression, Motor retardation, Uncooperativeness, Unusual thought content, Disorientation, Poor attention, Lack of judgment and insight, Disturbance of volition, Poor impulse control, Preoccupation, Active social avoidance). Minimum score is 16, maximum score is 112. The higher score- the worse outcome. The biggest reduction of score from baseline- a better efficacy.
Measure includes PANSS-Positive (range 8-30), PANSS-General Psychopathological (PANSS-G)(range 17-70), total PANSS score (range 37-143), PANSS aggression, hostility and depression cluster scores (range 4-19)."|Baseline and Day 21|ITT population, which comprise of patients who have baseline and at least ONE (1) set of post-baseline PANSS assessments. No imputation on PANSS Negative score.||Scores on a scale||Standard Deviation|Mean
799592|NCT00957528|Secondary|9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines|Serum inflammatory biomarkers (Interleukin B-1, 2,5,6,7,8,10,12 13, Interferon gamma, GM-CSF, and Tumor Necrosis Factor alpha)as measured by immunoassay at baseline and at five months|5 months|All subjects who completed the protocol.||pg/mL||Standard Deviation|Mean
804367|NCT00997555|Secondary|Length of ICU Stay|Number of ICU days (bronchoscopy 10 days, 95% CI +/- 10 days versus control 18 days, 95% CI +/- 12 days, p = 0.4).|until discharge from hospital, data reviewed every 6 months|||days||95% Confidence Interval|Median
799541|NCT00954122|Primary|Change From Baseline in Positive and Negative Syndrome Scale Excited Component (PANSS-EC) Score|PANSS- Excited Component (EC) subscale score will be calculated by adding together the following item scores: excitement (positive subscale item 4); hostility (positive subscale item 7); tension (general subscale item 4); uncooperativeness (general subscale item 8); poor impulse control (general subscale item 14). This is rated on a 7-point Likert scale from ‘absent’ to ‘extremely severe’ (score range 5 to 35 points; mean scores = 20 points clinically corresponds to severe agitation). Lower value gives the better outcome.|Baseline and Day 21|ITT population, which comprise of patients who have baseline and at least ONE (1) set of post-baseline PANSS assessments. No imputation on PANSS-EC score.||Scores on a scale||Standard Deviation|Mean
799542|NCT00956943|Secondary|Side Effects|frequency of serious adverse events|8 weeks|intent to treat||events|||Number
799543|NCT00956943|Primary|Biochemically Verified 7-day Point Prevalence Abstinence at the End of 8 Weeks of Treatment|quit rate verified with carbon monoxide breath sample (abstinence: less than or equal to 10ppm)|After 8 weeks of treatment with the patch, outcome will be measured.|intent to treat||participants|||Number
799544|NCT00957008|Primary|Body Weight|Body weight was assessed using a calibrated balance-beam scale.|nine month|||Kg||Standard Error|Least Squares Mean
799545|NCT00957008|Secondary|Blood Fasting Glucose||Month 9|Last observation carried forward||mg/dl||95% Confidence Interval|Least Squares Mean
799546|NCT00957008|Primary|Body Weight and Waist Circumference||Baseline, Month 4 and Month 9||||||
799547|NCT00957021|Secondary|Radiographic Outcome|Radiographic success/failure at 1, 2, and 5-year visits will be assessed. Radiographic failure is defined as a score of 10 or greater according to the Knee Society Roentgenographic Scoring System, regardless of symptoms. A migrating or shifting prosthesis with or without the disappearance of radiolucent lines is also a failure regardless of score.|1,2 and 5 years|Maximum number of knees evaluable at any interval.||knees|knees||Number
799548|NCT00957021|Secondary|Patient Outcome Lower-Extremity Activity Scale|The Lower-Extremity Activity Scale (LEAS) score at 1, 2, 3, 4 and 5-year intervals will be compared at each post-surgery visit with baseline to see if any improvement is seen for each time point.The LEAS is completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level. A level of 1 indicated that the subject was confined to bed all day while a level of 18 indicated that the subject was up and about at will inside and outside of the house, and also participated in vigorous physical activity, such as competitive level sports, on a daily basis.|1,2,3,4 and 5 years|Maximum number of knees available at any interval.||units on a scale|knees|Standard Deviation|Mean
799549|NCT00957021|Secondary|Patient Outcome WOMAC|"The Western Ontario and McMaster Osteoarthritis Index (WOMAC) scores at 1, 2, 3, 4 and 5-year visits will be compared between groups, when data is available. Additionally, comparison of scores at each post-surgery visit with baseline will be tested to see if any improvement is seen for each time point. The WOMAC collects information specific to osteoarthritis outcomes. The questionnaire uses a visual analog scale for pain, measuring factors of general pain, stiffness, and physical findings. Pain is scored from 0 to 100 for each set of factors, with 0 indicating no pain and 100 indicating extreme pain. Total WOMAC scores range from 0 to 300. Lower values represent better outcomes.
Data for the WOMAC is only available at the 5 year interval due to typographical errors noted on earlier interval forms rendering them invalid for comparison."|5 years|The number of knees evaluated at 5 years.||units on a scale|knees|Standard Deviation|Mean
799550|NCT00957021|Secondary|Patient Outcome SF-36|The SF-36 score at 1, 2, 3, 4 and 5-year visits will be compared at each post-surgery visit with baseline to see if any improvement is seen for each time point.The SF-36 includes a physical component and a mental component and is completed by the participant. Physical component and mental component scores were calculated on a scale ranging from 0 to 100. Low values represented a poor health state and high values represented a good health state.|1,2,3,4 and 5 years|Maximum number of knees evaluated at any interval.||units on a scale|knees|Standard Deviation|Mean
799551|NCT00957021|Secondary|Patient Outcome Knee Society Score|The Knee Society Scores (KSS) at 1, 2, and 5-year visits will be compared. Additionally, comparison of scores at each post-surgery visit with baseline will be tested to see if any improvement is seen at each time point. The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, ROM and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as “excellent,” “good,” “fair,” or “poor,” a higher value represents a better outcome.|1,2 and 5 years|Maximum number of knees evaluated at any interval.||units on a scale|knees|Standard Deviation|Mean
799552|NCT00957021|Primary|Range of Motion|The primary outcome of this study is to compare active range of motion values for the Triathlon PS Total Knee System.|2 years|Participants can have both knees replaced. Range of motion is measured for each knee, as such the number of knees evaluated can be greater than the number of participants.||degrees|Knees|Standard Deviation|Mean
799553|NCT00957034|Secondary|Percent Change Physician Global Assessment of Heart Failure Status|Physician rates improvement or deterioration in heart failure: Scale -7/very great deal worse, -6 great deal worse, -5 good deal worse, -4 moderately worse, -3 somewhat worse, -2 a little worse, -1 hardly any worse/almost the same, 0 no change, 1 hardly better/almost the same, 2 little better, 3 somewhat better, 4 moderately better, 5 good deal better, 6 great deal better, 7 very great deal better.|Baseline and Day 180|No statistical analysis performed due to early termination of the study. Study was stopped prior to any subjects reaching a timepoint for efficacy assessment. Safety results were available and recorded in the interim.||Percent Change||95% Confidence Interval|Least Squares Mean
799554|NCT00957034|Secondary|Percent Change Patient Global Assessment of Heart Failure Status|Four global questions classifying improvement or deterioration in heart failure - Since your last clinic vist, has there been any change in activity limitation / symptoms / emotions / overall quality of life, related to your heart failure? Scale -7/very great deal worse, -6 great deal worse, -5 good deal worse, -4 moderately worse, -3 somewhat worse, -2 a little worse, -1 hardly any worse/almost the same, 0 no change, 1 hardly better/almost the same, 2 little better, 3 somewhat better, 4 moderately better, 5 good deal better, 6 great deal better, 7 very great deal better.|Baseline and Day 180|No statistical analysis performed due to early termination of the study. Study was stopped prior to any subjects reaching a timepoint for efficacy assessment. Safety results were available and recorded in the interim.||Percent Change||95% Confidence Interval|Least Squares Mean
799555|NCT00957034|Secondary|Percent Change Minnesota Living With Heart Failure Questionnaire (MLHFQ) Overall Score and Domain Scores|Minnesota Living with Heart Failure Questionnaire assessing how much heart failure affects life during previous month. Three scales measuring physical dimension (8 items, score 0-40), emotional dimension (5 items, score 0-25) and overall score (all 21 items, score 0-105). Eight separate items measure social & economic impairments included as part of overall score.|Baseline and Day 180|No statistical analysis performed due to early termination of the study. Study was stopped prior to any subjects reaching a timepoint for efficacy assessment. Safety results were available and recorded in the interim.||Percent Change||95% Confidence Interval|Least Squares Mean
799556|NCT00957034|Secondary|Mortality or Hospitalizations|Composite endpoint - patients who were hospitalized or died during the trial.|Baseline and Day 180|No statistical analysis performed due to early termination of the study. Study was stopped prior to any subjects reaching a timepoint for efficacy assessment. Safety results were available and recorded in the interim.||Participants|||Number
799557|NCT00957034|Secondary|Percent Change From Baseline in Severity of Heart Failure (HF) as Measured by New York Heart Association (NYHA) Classification|Class I: Cardiac disease w/o limitation of physical activity. Class II: Cardiac disease resulting in slight limitation of physical activity. Comfortable at rest; ordinary activity results in fatigue, palpitation, dyspnea or anginal pain. Class III: Cardiac disease resulting in marked limitation of physical activity. Comfortable at rest; less than ordinary activity causes fatigue, palpitation, dyspnea or anginal pain. Class IV: Cardiac disease resulting in inability to carry on any physical activity w/o discomfort. Symptoms present at rest. Any physical activity increases discomfort.|Baseline and Day 180|No statistical analysis performed due to early termination of the study. Study was stopped prior to any subjects reaching a timepoint for efficacy assessment. Safety results were available and recorded in the interim.||Percent Change|||Number
799558|NCT00957034|Primary|Percent Change From Baseline in Six Minute Walking Test (6MWT), Meters|Measurement of distance walked as fast as possible on a hard flat pathway in six minutes|Baseline and Day 180|No statistical analysis performed due to early termination of the study. Study was stopped prior to any subjects reaching a timepoint for efficacy assessment. Safety results were available and recorded in the interim.||Percent Change||95% Confidence Interval|Least Squares Mean
799559|NCT00957047|Primary|PART II - Nº of Treatment-Emergent Adverse Events (TEAE)|Safety assessments were based primarily on AEs (Number of patients who experienced at least one AEs), and on whether these were related to the study medication, were serious, led to permanent discontinuation of study participation, or led to death.|1 year|||participants|||Number
799560|NCT00957047|Primary|PART I - Seizure Frequency|The primary efficacy endpoint is the natural log transformation of the seizure frequency per 4 weeks. The primary efficacy analysis was based on the ITT population. Efficacy analyses were performed chiefly using data from the 12-week maintenance period in Part I of the study. The primary efficacy variable is the ln transformation of the seizure frequency per 4 weeks. Seizure frequency was compared between each active treatment group and the placebo group using an ANCOVA that models seizure frequency as a function of baseline seizure frequency and treatment.|12-week maintenance period|The primary efficacy analysis was an ANCOVA that assessed reduction in seizure frequency per 4 weeks for the ITT population during the 12-week maintenance period||ln (Seizures) per 4 weeks||95% Confidence Interval|Least Squares Mean
799561|NCT00957242|Secondary|Fibrin D-dimer Change From Baseline to 16 Weeks|Biomarker that measures biologic activities in patients as opposed to response.|maximum of 48 weeks|||mg/ml||Standard Deviation|Mean
799562|NCT00957242|Secondary|Change in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) From Baseline to 16 Weeks|The DLCO measures the partial pressure difference between inspired and expired carbon monoxide.|Week 48 / Final Visit|||mL/min/mmHg||Standard Deviation|Mean
799563|NCT00957242|Secondary|Total Score St. George's Respiratory Questionnaire (SGRQ)|The SGRQ is a quality of life measurement used to assess respiratory well being with a 0*-100 range (*indicates better health--lower is better).|Week 16 Change from Baseline|All participants per intention-to-treat||score on a scale||Standard Deviation|Mean
799564|NCT00957242|Secondary|Change in 6-minute Walk Distance (6MWD)|The 6MWD is a measure of exercise tolerance. Change in exercise tolerance is calculated at the latest time point (up to 48 weeks) minus the earliest time point (at baseline).|Change from baseline to last visit (maximum of 48 weeks)|||meters||Standard Deviation|Mean
799565|NCT00957242|Secondary|Cardiovascular Mortality or Morbidity|Measured at 48 Weeks|maximum of 48 weeks|||events|||Number
799566|NCT00957242|Secondary|Respiratory-related Hospitalizations||maximum 48 weeks|||events|||Number
799567|NCT00957242|Secondary|Acute Exacerbations of Idiopathic Pulmonary Fibrosis (IPF)||maximum of 48 weeks|||events|||Number
799568|NCT00957242|Secondary|Bleeding Events||maximum of 48 weeks|||events|||Number
799569|NCT00957242|Secondary|All-cause Hospitalizations||maximum 48 weeks|||events|||Number
799570|NCT00957242|Secondary|Change in Forced Vital Capacity (FVC) From Baseline to 16 Weeks|Week-16 change from Baseline|16 weeks|||liters||Standard Deviation|Mean
799571|NCT00957242|Secondary|All Cause Mortality||maximum of 48 weeks|All participants per intention-to-treat (ITT)||events|||Number
799572|NCT00957242|Primary|Death, Non-bleeding/Non-elective Hospitalization, or >10% Drop in Forced Vital Capacity|Death, non-bleeding/non-elective hospitalization, or >10% drop in forced vital capacity.|Events up to 48 weeks|All participants per intention-to-treat (ITT)||events|||Number
799573|NCT00957268|Secondary|Observed Effect at 24 Hours Post-dose (E24) of the Baseline-corrected Glucagon-like Peptide-1 (GLP-1) Concentration|The observed effect at 24 hours post-dose (E24) of baseline-corrected glucagon-like peptide-1 was determined from the concentration-time curve. Baseline-corrected glucagon-like peptide-1 concentrations were calculated as the post-dose concentration at each post-dose time point minus the baseline (pre-dose) concentration.|1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dose|Pharmacodynamic set: All participants who received at least 1 dose of study drug and who had at least 1 measureable DPP-4 inhibition or GLP-1 concentration.||pmol/L||Standard Deviation|Mean
799615|NCT00957580|Secondary|Part 1: Maximum Plasma Concentration (Cmax) of Pimasertib Single Dose||Predose 0.5, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, and 10.0 hours post-dose on Day 1 of cycle 1; Regimen 1, 2 and 3|Pharmacokinetic analysis set included all the subjects who received at least 1 dose of trial medication and provided adequate PK samples per protocol. N (number of subject analyzed) signifies subjects evaluable for this outcome measure.||nanogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
799574|NCT00957268|Secondary|Time to Reach the Maximum Observed Effect of the Baseline-corrected Glucagon-like Peptide-1 (GLP-1) Concentration|The time to reach the maximum observed effect of baseline-corrected glucagon-like peptide-1 was determined from the concentration-time curve. Baseline-corrected glucagon-like peptide-1 concentrations were calculated as the post-dose concentration at each post-dose time point minus the baseline (pre-dose) concentration.|1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dose|Pharmacodynamic set: All participants who received at least 1 dose of study drug and who had at least 1 measureable DPP-4 inhibition or GLP-1 concentration.||hr||Full Range|Median
799575|NCT00957268|Secondary|Maximum Observed Effect (Emax) of the Baseline-corrected Glucagon-like Peptide-1 (GLP-1) Concentration|The maximum observed effect (Emax) of baseline-corrected glucagon-like peptide-1 was determined from the concentration-time curve. Baseline-corrected glucagon-like peptide-1 concentrations were calculated as the post-dose concentration at each post-dose time point minus the baseline (pre-dose) concentration.|1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dose|Pharmacodynamic set: All participants who received at least 1 dose of study drug and who had at least 1 measureable DPP-4 inhibition or GLP-1 concentration.||pmol/L||Standard Deviation|Mean
799576|NCT00957268|Secondary|Area Under the Plasma Effect-Time Curve From Time 0 to 24 Hours Post-dose (AUEC[0-24]) of the Baseline-corrected Glucagon-like Peptide-1 (GLP-1) Concentration|The area under the plasma effect-time curve from time 0 to 24 hours post-dose (AUEC[0-24]) of baseline-corrected glucagon-like peptide-1 was determined from the concentration-time curve. Baseline-corrected glucagon-like peptide-1 concentrations were calculated as the post-dose concentration at each post-dose time point minus the baseline (pre-dose) concentration.|1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dose|Pharmacodynamic set: All participants who received at least 1 dose of study drug and who had at least 1 measureable DPP-4 inhibition or GLP-1 concentration.||pmol•hr/L||Standard Deviation|Mean
799577|NCT00957268|Secondary|Observed Effect at 24 Hours Post-dose (E24) of Dipeptidyl Peptidase-4 (DPP-4) Inhibition|The observed effect at 24 hours post-dose (E24) of dipeptidyl peptidase-4 (DPP-4) inhibition was determined from the inhibition-time curve.|1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dose|Pharmacodynamic set: All participants who received at least 1 dose of study drug and who had at least 1 measureable DPP-4 inhibition or GLP-1 concentration.||Percentage inhibition||Standard Deviation|Mean
799578|NCT00957268|Secondary|Time to Reach the Maximum Observed Effect of Dipeptidyl Peptidase-4 (DPP-4) Inhibition|The time to reach the maximum observed effect of dipeptidyl peptidase-4 (DPP-4) inhibition was determined from the inhibition-time curve.|1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dose|Pharmacodynamic set: All participants who received at least 1 dose of study drug and who had at least 1 measureable DPP-4 inhibition or GLP-1 concentration.||hr||Full Range|Median
799579|NCT00957268|Secondary|Maximum Observed Effect (Emax) of Dipeptidyl Peptidase-4 (DPP-4) Inhibition|The maximum observed effect (Emax) of dipeptidyl peptidase-4 (DPP-4) inhibition was determined from the inhibition-time curve.|1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dose|Pharmacodynamic set: All participants who received at least 1 dose of study drug and who had at least 1 measureable DPP-4 inhibition or GLP-1 concentration.||Percentage inhibition||Standard Deviation|Mean
799580|NCT00957268|Secondary|Area Under the Plasma Effect-Time Curve From Time 0 to 24 Hours Post-dose (AUEC[0-24]) of Dipeptidyl Peptidase-4 (DPP-4) Inhibition|The area under the plasma effect-time curve from time 0 to 24 hours post-dose (AUEC[0-24]) of dipeptidyl peptidase-4 (DPP-4) inhibition was determined from the inhibition-time curve.|1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dose|Pharmacodynamic set: All participants who received at least 1 dose of study drug and who had at least 1 measureable DPP-4 inhibition or GLP-1 concentration.||Percentage inhibition•hr||Standard Deviation|Mean
799581|NCT00957268|Primary|AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Alogliptin|AUC(0-inf) is measure of area under the curve over the dosing interval (tau) (AUC(0-tau]), where tau is the length of the dosing interval in this study).|1 hour pre-dose and 1, 2, 4, 8, 12, 16, 24, 48, and 72 hours post-dose|Pharmacokinetic set: All participants who received at least 1 dose of study drug and who had at least 1 measureable plasma concentration of alogliptin.||ng•hr/mL||Standard Deviation|Mean
799582|NCT00957268|Primary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Alogliptin|Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.|1 hour pre-dose and 1, 2, 4, 8, 12, 16, 24, 48, and 72 hours post-dose|Pharmacokinetic set: All participants who received at least 1 dose of study drug and who had at least 1 measureable plasma concentration of alogliptin.||hr||Standard Deviation|Mean
799583|NCT00957268|Primary|Cmax: Maximum Observed Plasma Concentration for Alogliptin|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|1 hour pre-dose and 1, 2, 4, 8, 12, 16, 24, 48, and 72 hours post-dose|Pharmacokinetic set: All participants who received at least 1 dose of study drug and who had at least 1 measureable plasma concentration of alogliptin.||ng/mL||Standard Deviation|Mean
799584|NCT00957333|Secondary|Urinary Bladder Capacity||1 day||||||
799585|NCT00957333|Primary|Substance Abuse Situation Record|Substance abuse situation record: ketamine|1 day|||years||Full Range|Mean
799586|NCT00957372|Primary|PART II: Nº of Treatment-Emergent Adverse Events (TEAE)|The primary objective for Part II of the study was to evaluate the safety and tolerability of eslicarbazepine acetate (ESL, BIA 2-093) at doses titrated to an efficacy or safety endpoint over a 1-year open-label period. Safety assessments were based primarily on AEs (Number of participants with at least one treatment-emergent adverse events are reported); assessment of AEs was based on treatment relatedness, action taken on study drug, outcome, and causality.|1-year|There was no sample size estimate for Part II. Part II was a 1-year open-label extension for patients who had completed Part I and was willing to continue treatment in Part II.||participants|||Number
799587|NCT00957372|Primary|Seizure Frequency|The primary efficacy endpoint is the natural log transformation of the seizure frequency per 4 weeks. The primary efficacy analysis was based on results for the ITT population during the 12-week maintenance period. Seizure frequency was compared between each active treatment group and the placebo group using an ANCOVA model with treatment as a factor and seizure frequency as a covariate|12 weeks|The primary efficacy analysis was based on the ITT population.The intent-to-treat (ITT) population included all randomized patients with at least one dose of investigational product and at least one post-baseline seizure frequency assessment||ln (Seizures) per 4 weeks||95% Confidence Interval|Least Squares Mean
799593|NCT00957528|Secondary|Changes in Serum Markers of Bone Turnover.|"Measures of bone turnover markers in serum samples at baseline and at five months.The bone turnover markers analyzed include:
Markers associated with bone breakdown NTX (N-telopeptide) TRAP5b (tartrate-resistant acid phosphatase isoform 5b) Markers associated with bone formation Osteocalcin BAP (bone specific alkaline phosphatase) Regulators of bone formation iPTH (intact parathyroid hormone) increases in response to bone loss Calcitonin inhibits bone formation in response to elevated levels of serum calcium"|5 months|||nM BCE (Bone Collagen Equivalents)||Standard Error|Mean
799594|NCT00957528|Secondary|Changes in Bone Mineral Density as Measured by Dual Energy X-ray Absorptiometry (DEXA)|Bone mineral density measure by measured by dual energy x-ray absorptiometry (DEXA)measured at baseline and a five months|5 months|||gm/cm^2||Standard Error|Mean
799595|NCT00957528|Primary|Changes in Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DEXA)|Lean body mass is expressed in grams as calculated by Hologic DEXA.|5 months|All subjects who successfully completed the five month protocol.||grams||Standard Deviation|Mean
799596|NCT00957528|Primary|Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months|Maximum weight (pounds) lifted using Cybex weight machine in a single effort(1-RM) for upper extremities (biceps and triceps) and lower extremities quadriceps and hamstrings).|5 months|||pounds||Standard Deviation|Mean
799597|NCT00957528|Primary|Changes in Basal Muscle Protein Synthesis and Breakdown as Measured by Stable Isotope Metabolic Studies at Baseline and at Five Months|The fractional synthetic rate (FSR) of mixed muscle is calculated by directly measuring the incorporation of L-[ring-13C6]-phenylalanine into protein (%/hr),, using the precursor-product model: FSR = [(EP2 − EP1)/(EM•t)]•60•100, where EP1 and EP2 are the enrichments of bound L-[ring-13C6]-phenylalanine in the first and second muscle biopsies, t is the time interval (min) between biopsies, and EM is the mean L-[ring-13C6]-phenylalanine enrichment in the muscle intracellular pool.|5 Months|Subjects who completed the entire treatment protocol||Percent per hour (%/hr)||Standard Deviation|Mean
799598|NCT00957580|Secondary|Part 2: Number of Subjects With TEAEs, Serious TEAEs, TEAEs Leading to Death and TEAEs Leading to Permanent Treatment Discontinuation|An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that results in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.|Up to 3 years|This outcome measure was not analyzed as the trial was terminated during safety run-in (Part 1).|||||
799599|NCT00957580|Secondary|Part 1: Percentage of Subjects With Best Overall Response|The best overall response was reported as either of the following: (1) Morphologic complete remission (CR) = normalization of the peripheral blood absolute neutrophil count (PBANC) >1.0x10^9 per liter (/L), platelets >100x10^9 /L, bone marrow aspirate with less than or equal to (<=) 5 percent (%) blasts, no blasts with Auer rods (AML only). (2) Complete remission with incomplete blood count recovery (CRi) = Same as CR without normalization of PBANC and platelet count. (3) Partial remission (PR) = normalization of PBANC >1.0x10^9/L, platelets >100x10^9/L, and at least a 50% decrease in the percentage of marrow aspirate blasts to 5-25%, or marrow blasts less than (<) 5%. (4) Progressive disease (PD) = >50% increase in peripheral blood or bone marrow blasts. (5) Stable disease (SD) = Subjects who failed to achieve CR, CRi or PR and without criteria for PD.|Day 29 of every alternate 29-day cycle until progression reported between day of first subject randomized, September 2009, until cut-off date, December 2012|The efficacy analysis set included all subjects who received at least 1 administration of planned dose of pimasertib and had at least 1 efficacy assessment after the first dose. 'N’ (number of subjects analyzed)=subjects evaluable for this outcome measure.||Percentage of Subjects|||Number
799600|NCT00957580|Secondary|Part 1: Apparent Oral Volume of Distribution (Vz/f) of Pimasertib: Multiple Dose|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution after oral dose (Vz/f) was influenced by the fraction absorbed.|Pre dose 0.5, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, and 10.0 hours post dose in Cycle 1 on Day 19 to Day 21 (Regimen 1 and 2) or Day 26 (Regimen 3)|Pharmacokinetic analysis set included all the subjects who received at least 1 dose of trial medication and provided pharmacokinetic samples. ‘N’(number of subjects analyzed)=subjects evaluable for this measure.||liter||Geometric Coefficient of Variation|Geometric Mean
799601|NCT00957580|Secondary|Part 1: Apparent Oral Volume of Distribution (Vz/f) of Pimasertib for Pimasertib 75 mg Reporting Arm:Single Dose|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution after oral dose (Vz/f) was influenced by the fraction absorbed.|Predose 0.5, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, and 10.0 hours post-dose on Day 1 of cycle 1; Regimen 1, 2 and 3|"Pharmacokinetic analysis set included all the subjects who received at least 1 dose of trial medication and provided pharmacokinetic samples. 'N'(number of subjects analyzed)=subjects evaluable for this measure and n = subjects evaluable for the specified regimen."||liter||Standard Deviation|Mean
799602|NCT00957580|Secondary|Part 1: Apparent Oral Volume of Distribution (Vz/f) of Pimasertib:Single Dose|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution after oral dose (Vz/f) was influenced by the fraction absorbed. Data for Pimasertib 75 mg arm was not available for all the regimens combined, thus reported as separate outcome measure and not included in this outcome.|Predose 0.5, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, and 10.0 hours post-dose on Day 1 of cycle 1; Regimen 1, 2 and 3|Pharmacokinetic analysis set included all the subjects who received at least 1 dose of trial medication and provided pharmacokinetic samples. ‘N’(number of subjects analyzed)=subjects evaluable for this measure.||liter||Geometric Coefficient of Variation|Geometric Mean
799603|NCT00957580|Secondary|Part 1: Apparent Oral Clearance (CL/f) of Pimasertib: Multiple Dose|Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent clearance after oral dose (CL/f) is influenced by the fraction absorbed.|Pre dose 0.5, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, and 10.0 hours post dose in Cycle 1 on Day 19 to Day 21 (Regimen 1 and 2) or Day 26 (Regimen 3)|Pharmacokinetic analysis set included all the subjects who received at least 1 dose of trial medication and provided pharmacokinetic samples. ‘N’(number of subjects analyzed)=subjects evaluable for this measure.||liter/hour||Geometric Coefficient of Variation|Geometric Mean
799604|NCT00957580|Secondary|Part 1: Apparent Oral Clearance (CL/f) of Pimasertib for Pimasertib 75 mg Reporting Arm: Single Dose|Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent clearance after oral dose (CL/f) is influenced by the fraction absorbed.|Predose 0.5, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, and 10.0 hours post-dose on Day 1 of cycle 1; Regimen 1, 2 and 3|"Pharmacokinetic analysis set included all the subjects who received at least 1 dose of trial medication and provided pharmacokinetic samples. ‘N’(number of subjects analyzed)=subjects evaluable for this measure and n = subjects evaluable for the specified regimen."||liter/hour||Standard Deviation|Mean
799605|NCT00957580|Secondary|Part 1: Apparent Oral Clearance (CL/f) of Pimasertib: Single Dose|Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent clearance after oral dose (CL/f) is influenced by the fraction absorbed. Data for Pimasertib 75 mg arm was not available for all the regimens combined, thus reported as separate outcome measure and not included in this outcome.|Predose 0.5, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, and 10.0 hours post-dose on Day 1 of cycle 1; Regimen 1, 2 and 3|Pharmacokinetic analysis set included all the subjects who received at least 1 dose of trial medication and provided pharmacokinetic samples. ‘N’(number of subjects analyzed)=subjects evaluable for this measure.||liter/hour||Geometric Coefficient of Variation|Geometric Mean
799606|NCT00957580|Secondary|Part 1: Area Under Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Pimasertib: Multiple Dose|The AUC0-inf was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity. It is obtained from AUC0-t plus AUCt-infinity.|Pre dose 0.5, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, and 10.0 hours post dose in Cycle 1 on Day 19 to Day 21 (Regimen 1 and 2) or Day 26 (Regimen 3)|Pharmacokinetic analysis set included all the subjects who received at least 1 dose of trial medication and provided pharmacokinetic samples. N (number of subject analyzed) signifies subjects evaluable for this outcome measure.||hour*nanogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
799607|NCT00957580|Secondary|Part 1: Area Under Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Pimasertib: Single Dose|The AUC0-inf was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity. It is obtained from AUC0-t plus AUCt-infinity.|Predose 0.5, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, and 10.0 hours post-dose on Day 1 of cycle 1; Regimen 1, 2 and 3|Pharmacokinetic analysis set included all the subjects who received at least 1 dose of trial medication and provided pharmacokinetic samples. ‘N’(number of subjects analyzed)=subjects evaluable for this measure.||hour*nanogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
799608|NCT00957580|Secondary|Part 1: Area Under Curve From Time Zero to Last Sampling Time at Which the Concentration is at or Above Lower Limit of Quantification (AUC0-t) of Pimasertib: Multiple Dose||Pre dose 0.5, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, and 10.0 hours post dose in Cycle 1 on Day 19 to Day 21 (Regimen 1 and 2) or Day 26 (Regimen 3).|"Pharmacokinetic analysis set included all the subjects who received at least 1 dose of trial medication and provided pharmacokinetic samples. ‘n =Subjects evaluable for this outcome measure for specified categories for each reporting group, respectively."||hour*nanogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
799609|NCT00957580|Secondary|Part 1: Area Under Curve From Time Zero to Last Sampling Time at Which the Concentration is at or Above Lower Limit of Quantification (AUC0-t) of Pimasertib: Single Dose||Predose 0.5, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, and 10.0 hours post-dose on Day 1 of cycle 1; Regimen 1, 2 and 3|Pharmacokinetic analysis set included all the subjects who received at least 1 dose of trial medication and provided pharmacokinetic samples. N (number of subject analyzed) signifies subjects evaluable for this outcome measure.||hour*nanogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
799610|NCT00957580|Secondary|Part 1: Apparent Terminal Half-Life (t1/2) of Pimasertib: Multiple Dose|The apparent terminal half-life was defined as the time required for the plasma concentration of drug to decrease 50% in the final stage of its elimination.|Pre dose 0.5, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, and 10.0 hours post dose in Cycle 1 on Day 19 to Day 21 (Regimen 1 and 2) or Day 26 (Regimen 3).|Pharmacokinetic analysis set included all the subjects who received at least 1 dose of trial medication and provided pharmacokinetic samples. N (number of subject analyzed) signifies subjects evaluable for this outcome measure.||hour||Geometric Coefficient of Variation|Geometric Mean
799611|NCT00957580|Secondary|Part 1: Apparent Terminal Half-Life (t1/2) of Pimasertib: Single Dose|The apparent terminal half-life was defined as the time required for the plasma concentration of drug to decrease 50% in the final stage of its elimination.|Predose 0.5, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, and 10.0 hours post-dose on Day 1 of cycle 1; Regimen 1, 2 and 3|Pharmacokinetic analysis set included all the subjects who received at least 1 dose of trial medication and provided pharmacokinetic samples. N (number of subject analyzed) signifies subjects evaluable for this outcome measure.||hour||Geometric Coefficient of Variation|Geometric Mean
799612|NCT00957580|Secondary|Part 1: Time to Reach Maximum Plasma Concentration (Tmax): Multiple Dose||Pre dose 0.5, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, and 10.0 hours post dose in Cycle 1 on Day 19 to Day 21 (Regimen 1 and 2) or Day 26 (Regimen 3)|Pharmacokinetic analysis set included all the subjects who received at least 1 dose of trial medication and provided pharmacokinetic samples per protocol. Number of subjects analysed refer to the subjects evaluable for this outcome measure.||hour||Geometric Coefficient of Variation|Geometric Mean
799613|NCT00957580|Secondary|Part 1: Time to Reach Maximum Plasma Concentration (Tmax): Single Dose||Predose 0.5, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, and 10.0 hours post-dose on Day 1 of cycle 1; Regimen 1, 2 and 3|Pharmacokinetic analysis set included all the subjects who received at least 1 dose of trial medication and provided pharmacokinetic samples per protocol. N (number of subject analyzed) signifies subjects evaluable for this outcome measure.||hour||Geometric Coefficient of Variation|Geometric Mean
799614|NCT00957580|Secondary|Part 1: Maximum Plasma Concentration (Cmax) of Pimasertib Multiple Dose||Pre dose 0.5, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, and 10.0 hours post dose in Cycle 1 on Day 19 to Day 21 (Regimen 1 and 2) or Day 26 (Regimen 3).|Pharmacokinetic analysis set included all the subjects who received at least 1 dose of trial medication and provided adequate PK samples per protocol. N (number of subject analyzed) signifies subjects evaluable for this outcome measure.||nanogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
799873|NCT00959647|Primary|Percentage of Participants Who Discontinued Treatment Due to an Adverse Event||Baseline until 30 days following the last administration of study treatment|Safety population: All participants who had received at least 1 dose of study medication.||Percentage of participants|||Number
799616|NCT00957580|Secondary|Part 1: Number of Subjects With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death and TEAEs Leading to Permanent Treatment Discontinuation|An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs include both SAEs and non-SAEs.|Baseline up to 3 years|The safety analysis set included all the subjects who received at least one administration of the trial medication.||Subjects|||Number
799617|NCT00957580|Primary|Part 2: Percentage of Subjects With Best Overall Response|The best overall response was to be reported as either of the following: (1) Morphologic complete remission (CR) = normalization of the peripheral blood absolute neutrophil count (PBANC) >1.0x10^9 per liter (/L), platelets >100x10^9 /L, bone marrow aspirate with less than or equal to (<=) 5 percent (%) blasts, no blasts with Auer rods (AML only). (2) Complete remission with incomplete blood count recovery (CRi) = Same as CR without normalization of PBANC and platelet count. (3) Partial remission (PR) = normalization of PBANC >1.0x10^9/L, platelets >100x10^9/L, and at least a 50% decrease in the percentage of marrow aspirate blasts to 5-25%, or marrow blasts less than (<) 5%. (4) Progressive disease (PD) = >50% increase in peripheral blood or bone marrow blasts. (5) Stable disease (SD) = subjects who failed to achieve CR, CRi or PR and without criteria for PD.|Day 29 of every 29-day cycle until progression reported between day of first subject randomized, September 2009, until cut-off date, December 2012|Due to limited anti-leukemic effects observed in the safety run-in part decision was made not to conduct part 2 hence this outcome measure was not assessed. Effects observed in the safety run-in part decision was made not to conduct part 2 hence this outcome measure was not assessed.|||||
799618|NCT00957580|Primary|Part 1: Number of Subjects With Dose Limiting Toxicities (DLTs)|The DLT was any toxicity that resulted in treatment delay for more than (>) 2 weeks due to treatment-related adverse effects, or any Grade greater than or equal to (>=) 3 non-hematological toxicity excluding Grade 4 asymptomatic increases in liver function tests reversible within 7 days in subjects with liver involvement, and Grade 3 asymptomatic increases in liver function tests reversible within 7 days for subjects without liver involvement, Grade 3 vomiting unless encountered and persistent for more than 3 days despite adequate and optimal therapy, and Grade 3 diarrhea unless encountered and persistent for more than 3 days despite adequate and optimal anti-diarrhea therapy at any DL and judged to be possibly or probably related to the trial treatment by the Investigator and/or the Sponsor.|Baseline Up to Day 29 of Cycle 1|The DLT analysis set included all subjects who received over 90 percent (%) administration of trial medication in Cycle 1 or showed a DLT.||subjects|||Number
799619|NCT00957593|Secondary|Perinatal Outcomes||24-72 hours||||||
799620|NCT00957593|Primary|Cesarean Delivery|Mode of delivery is the primary outcome|24-72 hours from admission for induction|||Cesarean deliveries|||Number
799621|NCT00957658|Secondary|Wrist DXA Scan Analysis|DXA is a bone densitometry scan that measures bone mineral density and assigns a T-score. This score shows the amount of bone a patient has compared with a young adult of the same gender with peak bone mass. A score above -1 is considered normal. A score between -1 and -2.5 is classified as osteopenia (low bone mass). A score below -2.5 is defined as osteoporosis.|5 years|Participants with available data: 107 hips had DXA scan T-scores at 5 years.||T-score|hips|Standard Deviation|Mean
799622|NCT00957658|Secondary|Acetabular Insert Wear|The linear wear rate of the polyethylene acetabular insert is measured radiographically and reported at 5 years.|5 years|Participants with available data: 97 hips were evaluated for wear rate at 5 years.||millimeters per year|hips|Standard Deviation|Mean
799623|NCT00957658|Secondary|PEQ (Patient Evaluation Questionnaire) Percent Achievement|"The PEQ is a study sponsor generated outcomes form. It is a one page questionnaire completed by the participant to assess lifestyle recovery post-surgery. Preoperatively, participants are asked to identify 3 of 12 different expectations that they most want to achieve after hip surgery. At 6 months,1 year and 2 years post-surgery participants evaluated the 3 expectations they identified and assessed their overall satisfaction and percent achievement.
EXPECTATIONS KEY:
Participate in recreational activities (dancing,traveling,gardening)
Exercise or participate in sports
Independently perform household chores/daily routine
Easily change position,sit to stand/stand to sit
Remove need for cane crutch or walker
Use stairs normally step by step
Ability to sleep through night
Maintain social activites,caring for someone,playing with children
Use public transportation or drive
Maintain psychological well-being
Maintain sexual activity
Maintain employment"|6 months, 1 year, 2 years|Participants with available data: A total of 206 hips had 6 month data; a total of 203 hips had 1 year data; a total of 178 hips had 2 year data. Participants select 3 expectations and assess percent achievement (100%,75%,50%,25%,or 0%) at 6 mos, 1 yr and 2 yrs.||percentage of participants|hips||Number
799624|NCT00957658|Secondary|PEQ (Patient Expectation Questionnaire) Overall Satisfaction|"The PEQ is a study sponsor generated outcomes form. It is a one page questionnaire completed by the participant to assess lifestyle recovery post-surgery. Preoperatively, participants are asked to identify 3 of 12 different expectations that they most want to achieve after hip surgery. At 6 months,1 year and 2 years post-surgery participants evaluated the 3 expectations they identified and assessed their overall satisfaction and percent achievement.
EXPECTATIONS KEY:
Participate in recreational activities (dancing,traveling,gardening)
Exercise or participate in sports
Independently perform household chores/daily routine
Easily change position,sit to stand/stand to sit
Remove need for cane crutch or walker
Use stairs normally step by step
Ability to sleep through night
Maintain social activites,caring for someone,playing with children
Use public transportation or drive
Maintain psychological well-being
Maintain sexual activity
Maintain employment"|6 months, 1 year and 2 years|Participants with available data: A total of 206 hips had 6 month data; a total of 203 hips had 1 year data; a total of 178 hips had 2 year data. Percentage of participants who were satisfied with the result is reported for each expectation at these intervals.||percentage of particpants|hips||Number
799625|NCT00957658|Secondary|Change in Lower Extremity Activity Scale (LEAS) Score|The change in LEAS is reported by comparing the mean preoperative, 2 and 5 year postoperative scores.The LEAS is completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level. The mean preoperative, 2 and 5 year scores are reported to assess improvement.|Preoperative, 2 and 5 years|Participants with available data: A total of 231 hips had a preoperative score, 181 had a 2 year, and 129 had a 5 year score.||units on a scale|hips|Standard Deviation|Mean
799626|NCT00957658|Secondary|Change in SF-12 Score|The change in SF-12 is reported by comparing the mean preoperative, 2 and 5 year postoperative scores.The SF-12 Health Survey is a 12-item patient completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.|Preoperative, 2 and 5 years|Participants with available data: A total of 217 hips had preoperative scores, 175 had 2 year and 121 had 5 year scores.||units on a scale|hips|Standard Deviation|Mean
799627|NCT00957658|Secondary|Change in Harris Hip Score (HHS)|The change in HHS is reported by comparing the mean preoperative, 2 and 5 year postoperative scores. Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score of less than or equal to 79 is considered fair-poor. 90-100 = excellent, 80-89 = good, 70-79 = fair, 0-69 = poor.|Preoperative, 2 and 5 years|Participants with available data: A total of 195 hips had a preoperative score, 174 had a 2 year score, and 117 had a 5 year score.||units on a scale|hips|Standard Deviation|Mean
799628|NCT00957658|Secondary|Revision/Removal Rates|The percentage (%) of hips with revision or removal of any total hip replacement component (acetabular cup, femoral stem or femoral head) is reported at the 2 and 5 year postoperative intervals.|2 and 5 years|Participants with available data: The revision/removal rate of any total hip replacement component at 2 years is reported for 182 hips/176 participants. The revision/removal rate of any component at 5 years is reported for 141 hips/136 participants.||percentage of hips/any component revised|hip||Number
799629|NCT00957658|Secondary|Percentage (%) of Hip Stems With Aseptic Loosening|Aseptic loosening is defined as a continuous radiolucency that surrounds the entire femoral stem porous coating-bone interface and that measures greater than 2 mm in thickness, and 5 mm or more of stem subsidence. Continuous radiolucency must be present in Zones 1, 2, 6 and 7 of the AP radiographic view and/or present in Zones 8, 9, 13 and 14 of the M/L radiographic view.|5 years|Participants with available data: 111 hips in 106 participants had a radiographic evaluation at 5 years.||percentage of hips|hips||Number
799630|NCT00957658|Primary|Combined Percentage (%) Cases Without Aseptic Loosening, Intraoperative Femoral Fracture or Thigh Pain||2 years|||percentage of hips|hips||Number
799631|NCT00957684|Primary|Part I: Seizure Frequency|The primary efficacy endpoint is the natural log transformation of the seizure frequency per 4 weeks. The primary efficacy analysis was based on the intention-to-treat (ITT) population. Efficacy analyses were performed chiefly using data from the 12-week maintenance period in Part I of the study. The primary efficacy variable is the ln transformation of the seizure frequency per 4 weeks. Seizure frequency was compared between each active treatment group and the placebo group using an ANCOVA that models seizure frequency as a function of baseline seizure frequency and treatment.to a “frequency per 4 weeks” basis|12-week maintenance period|The primary efficacy analysis was based on the ITT population.||ln (Seizures) per 4 weeks||95% Confidence Interval|Least Squares Mean
799657|NCT00957944|Secondary|AUC(0-tz) Norm (Apparent Dose) of Unconjugated Rotigotine|The AUC(0-tz) norm (apparent dose) is the area under the plasma concentration- time curve from zero up to the last analytically quantifiable concentration normalized by apparent dose (mg).|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)||(ng/ mL)*(h/ mg)||Standard Deviation|Mean
799874|NCT00959647|Primary|Percentage of Participants Who Experienced at Least 1 Adverse Event||Baseline until 30 days following the last administration of study treatment|Safety population: All participants who had received at least 1 dose of study medication.||Percentage of participants|||Number
799642|NCT00957905|Other Pre-specified|Time to Tumor Response||From treatment start until first documented CR or PR, assessed up to 4 years||||||
799643|NCT00957905|Other Pre-specified|Progression-free Survival||From treatment start until first documented progression or death, assessed up to 4 years||||||
799644|NCT00957905|Other Pre-specified|Toxicity|graded using the NCI CTCAE version 4.0.See adverse event section|Up to 4 years||||||
799645|NCT00957905|Primary|Objective Response Rate|"Number of Participants with Partial Response (PR), Stable Disease (SD), Progression of Disease (POD) Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (POD); POD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions"|Within 3 courses of treatment|||participants|||Number
799646|NCT00957944|Secondary|Apparent Dose|Apparent dose of unconjugated rotigotine in mg. The apparent dose of unconjugated rotigotine was determined from the patches removed on Day 2.|48 hours|Pharmacokinetic Set (PKS)||mg||Standard Deviation|Mean
799647|NCT00957944|Secondary|CL/f of Unconjugated Rotigotine|The CL/f is the apparent total body clearance.|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)||L/h||Standard Deviation|Mean
799648|NCT00957944|Secondary|t1/2 of Unconjugated Rotigotine|The t1/2 is the terminal half- life.|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)||hour (h)||Standard Deviation|Mean
799649|NCT00957944|Secondary|λz of Unconjugated Rotigotine|The λz is the rate constant of elimination.|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)||1/ hour (1/h)||Standard Deviation|Mean
799650|NCT00957944|Secondary|MRT of Unconjugated Rotigotine|The MRT is the mean residence time.|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)||hour (h)||Standard Deviation|Mean
799651|NCT00957944|Secondary|Tmax of Unconjugated Rotigotine|The tmax is the time to reach a maximum plasma concentration after patch application.|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)||hour (h)||Full Range|Median
799652|NCT00957944|Secondary|Cmax,Norm (BW) of Unconjugated Rotigotine|The Cmax,norm (BW) is the maximum plasma concentration normalized by body weight(kg).|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)||(ng/ mL) * kg||Standard Deviation|Mean
799653|NCT00957944|Secondary|Cmax,Norm (Apparent Dose) of Unconjugated Rotigotine|The Cmax,norm (apparent dose) is the maximum plasma concentration normalized by apparent dose(mg).|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)||(ng/ mL)/ mg||Standard Deviation|Mean
799654|NCT00957944|Secondary|AUC(0-∞) Norm (BW)|The AUC(0-∞) norm (BW) is the area under the plasma concentration- time curve from zero up to infinity normalized by body weight (kg).|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)||(ng/ mL)*h*kg||Standard Deviation|Mean
799655|NCT00957944|Secondary|AUC(0-∞) Norm (Apparent Dose)|The AUC(0-∞) norm (apparent dose) is the area under the plasma concentration- time curve from zero up to infinity normalized by apparent dose (mg).|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)||(ng/ mL)*(h/ mg)||Standard Deviation|Mean
799656|NCT00957944|Secondary|AUC(0-tz) Norm (BW) of Unconjugated Rotigotine|The AUC(0-tz) norm (BW) is the area under the plasma concentration- time curve from zero up to the last analytically quantifiable concentration normalized by body weight (kg).|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)||(ng/ mL)*h*kg||Standard Deviation|Mean
799875|NCT00959647|Secondary|Incidence of Adverse Events Leading to GDC-0449 Discontinuation||30 days following the last administration of study treatment||||||
799658|NCT00957944|Primary|AUC(0-∞) of Unconjugated Rotigotine|The AUC(0-∞) is the area under the plasma concentration- time curve from zero up to infinity|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)||(ng/ mL)*h||Standard Deviation|Mean
799659|NCT00957944|Primary|Cmax of Unconjugated Rotigotine|The Cmax is the maximum plasma concentration.|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)||ng/ mL||Standard Deviation|Mean
799660|NCT00957944|Primary|AUC(0-tz) of Unconjugated Rotigotine|The AUC(0-tz) is the area under the plasma concentration- time curve from zero up to the last analytically quantifiable concentration.|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)||(ng/ mL)*h||Standard Deviation|Mean
799661|NCT00957996|Secondary|Survival (Kaplan-Meier Estimates)|Survival was calculated as the number of days from initiation of study drug until death or last contact. Overall survival was estimated by the method of Kaplan-Meier; 95% confidence intervals for 14- and 28-day survival were presented by treatment group. Subjects who had not died were censored at the date of last contact.|14 and 28 days|The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology.||Percent Survival||95% Confidence Interval|Number
799662|NCT00957996|Other Pre-specified|Number of Participants Who Required More Than 5 Days of Peramivir Treatment|The number of subjects who continued more than 5 days were as reported on the Continuation of Treatment CRF page.|28 days|The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology.||participants|||Number
799663|NCT00957996|Secondary|Duration of Postbaseline ICU Admission (Kaplan-Meier Estimate)|The duration of ICU admission after initiation of treatment was estimated by the method of Kaplan-Meier. Subjects who were not discharged from the ICU were censored at the time of their last assessment|28 days|The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology.||days||95% Confidence Interval|Median
799664|NCT00957996|Secondary|Number of Participants Admitted to ICU After Initiation of Treatment|The number of subjects experiencing ICU admission after initiation of treatment.|28 days|The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology.||participants|||Number
799665|NCT00957996|Secondary|Number of Participants Experiencing Influenza-related Complications|Influenza-related complications were defined as the occurrence of sinusitis, otitis, bronchitis and pneumonia as reported on the Influenza-related complications CRF.|28 days|The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology.||participants|||Number
799666|NCT00957996|Secondary|Time to Hospital Discharge|Time to hospital discharge, defined as the number of days from initiation of study drug until the subject is discharged from the hospital, was estimated using the method of Kaplan-Meier. The 95% confidence interval about the median was presented. Subjects who were not discharged during the study period were censored at the last study visit. Subjects who died prior to discharge were censored at the longest observed time to discharge.|28 days|The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology.||days||95% Confidence Interval|Median
799667|NCT00957996|Secondary|Time to Resumption of Usual Activities|Subject’s ability to perform usual activities as determined from the visual analog scale (scale ranges from 0 to 10 where 0 indicates subject was unable to perform usual activities at all and 10 indicates subject is able to perform all usual activities fully) was summarized by study visit day and treatment group. The median time to resumption of usual daily activities and associated 95% CI was estimated using the method of Kaplan-Meier for adults and adolescents. Subjects who did not return to the pre-study level of performance of usual daily activities were censored at the time of their last non-missing visual analog scale value. A separate analysis was conducted for children.|28 days|The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology.||hours||95% Confidence Interval|Median
799668|NCT00957996|Secondary|Time to Resolution of Fever|Time to resolution of fever was the number of hours from initiation of study treatment until temperature was ≤37.2°C/≤99°F oral or ≤37.8°C/≤100°F rectal or tympanic for at least 24 hours with no antipyretic medication taken within 4 hours prior to the temperature measurement. Subjects who did not achieve resolution of fever were censored at the time of their last assessment. The 95% confidence interval about the median were presented.|28 days|The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology.||hours||95% Confidence Interval|Median
799669|NCT00957996|Secondary|Time to Alleviation of Symptoms|Time to alleviation of symptoms, defined as the time from initiation of study drug until the start of the 24 hour period where all seven symptoms of influenza are recorded as none or mild, was estimated using the method of Kaplan-Meier (adolescents and adults). The 95% confidence interval about the median was presented. Subjects who did not experience alleviation of symptoms were censored at the time of the last non-missing symptom assessment.|28 days|The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology. Symptom data for 18 subjects was missing.||hours||95% Confidence Interval|Median
799670|NCT00957996|Secondary|Number of Participants With Clinical Resolution|Clinical resolution was defined as normalization of at least 4 of the 5 signs of clinical stability (including both body temperature and transcutaneous oxygen saturation) for at least 24 hours.|28 days|The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology.||participants|||Number
799876|NCT00959647|Secondary|Incidence and Severity of All Adverse Events and Serious Adverse Events||30 days following the last administration of study treatment||||||
799671|NCT00957996|Secondary|Time to Clinical Resolution|Time to clinical resolution was the number of hours from initiation of study treatment until 4 of the 5 signs of clinical stability (including both body temperature and transcutaneous oxygen saturation) met resolution criteria that was maintained for at least 24 hours. The median time to clinical resolution and associated 95% confidence interval were estimated for each treatment group using the method of Kaplan-Meier. Subjects who did not achieve clinical resolution were censored at the time of their last assessment.|28 days|The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology.||hours||95% Confidence Interval|Median
799672|NCT00957996|Secondary|Change in Influenza Virus Titer, as Measured by Quantitative RT-PCR (log10 vp/mL)|The time-weighted change from baseline in viral titer measured by RT-PCR was calculated on a by-subject basis through 216 hours using the trapezoidal rule with all available data minus the baseline value. Ninety-five percent confidence intervals about the median time-weighted change from baseline were presented for each treatment group.|Baseline, 48, 108, 216 hours|The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology. Overall, 41 subjects were excluded due to negative Baseline titers (viral particles/mL RT-PCR value 1.58 for Influenza A and 1.49 for Influenza B).||log10 viral particles/mL||95% Confidence Interval|Median
799673|NCT00957996|Primary|Change From Baseline in Influenza Virus Titer (48 Hours)|The time-weighted change from baseline in log10 tissue culture infective dose50 (TCID50/mL) was calculated on a by-subject basis through 48 hours using the trapezoidal rule with all available data minus the baseline value. Ninety-five percent confidence intervals about the median time-weighted change from baseline were presented for each treatment group.|Baseline and 48 hours|The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology. Overall, 83 subjects were excluded due to negative Baseline titers (log10 TCID50 0.5).||log10 TCID50/mL||95% Confidence Interval|Median
799674|NCT00958009|Secondary|Multiple Secondary Endpoints Were Assessed, Based on Questions From the User Trial Questionnaire Related to the Single-use Autoinjector Device Use-related Outcomes.|The User Trial Questionnaire was used to assess the ease of use, functional reliability, overall satisfaction with device attributes, convenience, safety and portability of the device. Mean and confidence intervals refer to proportion of subjects responding positively to question. Secondary endpoints presented for decriptive purposes only thus no statistical analysis performed.|at 12 weeks|Subjects in the all enrolled analysis set who received at least one dose of IMP were included in the ITT analysis set. This analysis set was used to analyze the primary and secondary variables and all safety data.||Proportion of subjects||95% Confidence Interval|Mean
799675|NCT00958009|Primary|Proportion of Relapsing Multiple Sclerosis (RMS) Subjects Rating the Single-use Autoinjector as 'Easy to Use' or 'Very Easy to Use' for Self-injection in a User Trial Questionnaire|Data from the User Trial Questionnaire, Question 14 (Overall, how do you rate your experience with using the injection device?) Mean and confidence interval refer to proportion of subjects responding positively to question. Missing values were replaced with worst case response.|at 12 weeks|Subjects in the all enrolled analysis set who received at least one dose of investigational medicinal product (IMP) were included in the ITT analysis set. This analysis set was used to analyze the primary and secondary variables and all safety data.||Proportion of subjects||95% Confidence Interval|Mean
799676|NCT00958035|Primary|Percentage of Treatment Responders in Overall Eyelash Prominence at Month 4|Percentage of treatment responders in overall eyelash prominence, defined as at least a 1-grade improvement from baseline at Month 4 in the Global Eyelash Assessment (GEA) Scale. The GEA is a 4-point scale in which eyelash prominence is assessed from 1 (minimal prominence) to 4 (very marked prominence).|Month 4|Intent-to-Treat: All randomized subjects||Percentage of Patients|||Number
799677|NCT00958074|Secondary|Changes in the Physicians Serial Assessment of Erythroderma Score||Baseline to 30 days post-treatment||||||
799678|NCT00958074|Secondary|Changes in Sezary Cell Count Measured by Serial Flow Cytometry Measurements||Baseline to 30 days post-treatment||||||
799679|NCT00958074|Secondary|Safety and Tolerability of Dose-adjusted Vorinostat|Toxicities will be graded in severity according to the guidelines outlined in the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3.0.|Up to 30 days post-treatment||||||
799680|NCT00958074|Secondary|Objective Response Rate of Extracutaneous Manifestations of CTCL (Lymph Node Enlargement, Sezary Cells in Peripheral Blood);|Assessed by changes in the sum of the products in the greatest diameters of enlarged lymph nodes by serial computed tomography (CT) or positron emission tomography (PET)/CT scans.|Up to 30 days post-treatment||||||
799681|NCT00958074|Primary|Objective Response|Defined as either no evidence of clinical disease or marked improvement (>= 50%) decrease in the modified Severity-Weighted Assessment Tool (mSWAT) skin assessment score compared to baseline.|After at least 14 days. With Confirmation after additional 28 days.|In cohort 1, only 3 of the 4 subjects consented were used for analysis. 1 patient in this cohort only completed 3 days of treatment before removing themselves from treatment and withdrawing consent. This patient was deemed inevaluable, as the timeframe for initial evaluation is 14 days.||percentage of total|||Number
799682|NCT00958126|Secondary|Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination|"Unsolicited adverse event (UAE) grading:
Grade 1 (mild): Symptoms were easily tolerated and did not interfere with daily activities.
Grade 2 (moderate): Enough discomfort to cause some interference with daily activities.
Grade 3 (severe): Symptoms that prevented normal, everyday activities."|Day 0 to Day 20 after each vaccination; up to Day 180 after the last vaccination for SAEs, AESI and NOCI|The Safety Population comprised all randomized participants who received at least one dose of study vaccine and provided follow-up safety data.||percentage of participants|||Number
799683|NCT00958126|Secondary|Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI)|A NOCI was defined as the diagnosis of a new medical condition that was chronic in nature, including those potentially controllable by medication (eg, diabetes, asthma).|Up to 180 days after the last vaccination|The Safety Population comprised all randomized participants who received at least one dose of study vaccine and provided follow-up safety data.||percentage of participants|||Number
810871|NCT01056315|Secondary|Change From Baseline of the Weekly Mean of Current Pain Intensity (on an 11-point NRS) in the Evening and in the Morning, Respectively.||Baseline, weekly mean||||||
799684|NCT00958126|Primary|Percentage of Participants Achieving an HI Antibody Titer of 1:40 or More 21 Days After the Second Vaccination||21 days after the second vaccination|The Evaluable Population (for the second vaccination) comprised all randomized participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).||percentage of participants||95% Confidence Interval|Number
799685|NCT00958126|Primary|Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After the First Vaccination||21 days after the first vaccination|The Evaluable Population (for the first vaccination) comprised all randomized participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).||percentage of participants||95% Confidence Interval|Number
799686|NCT00958126|Primary|Seroconversion Rate 21 Days After the Second Vaccination|Seroconversion rate: the percentage of participants achieving seroconversion in HI antibody titer. Seroconversion is defined as participants with a pre-vaccination titer of less than 1:10 achieving a post-vaccination HI antibody titer of 1:40 or more; or participants with a pre-vaccination HI titer of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titer.|21 days after the second vaccination|The Evaluable Population (for the second vaccination) comprised all randomized participants who received the second study vaccine; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).||percentage of participants||95% Confidence Interval|Number
799687|NCT00958126|Secondary|Duration of Solicited Local Adverse Events After the First Vaccination||During the 7 days after the first vaccination, and day 7 - day 21 for ongoing AEs|The Safety Population (first vaccination) comprised all randomized participants who received the first vaccination and provided follow-up safety data.||days||Standard Deviation|Mean
799688|NCT00958126|Secondary|Frequency and Intensity of Solicited Adverse Events After the First Vaccination|Grade 3 solicited adverse event (AE) definitions: Prevented normal daily activities; Size > 100 mm for injection site redness or induration/swelling; Temperature 102.2°F (39.0°C) or more for fevers.|During the 7 days after the first vaccination|The Safety Population (first vaccination) comprised all randomized participants who received the first vaccination and provided follow-up safety data.||percentage of participants|||Number
799689|NCT00958126|Primary|Seroconversion Rate 21 Days After the First Vaccination|Seroconversion rate: the proportion of participants achieving seroconversion in hemagglutination inhibition (HI) antibody titer. Seroconversion is defined as participants with a baseline titer of less than 1:10 achieving a post-vaccination HI antibody titer of 1:40 or more; or participants with a baseline HI titer of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titer.|21 days after the first vaccination|The Evaluable Population (for the first vaccination) comprised all randomized participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).||percentage of participants||95% Confidence Interval|Number
799690|NCT00958165|Primary|Chronic Effectiveness in Treating PAF as Demonstrated by no AF Recurrences After the Blanking Period and During the 12-month Follow-up Period.||12 months|Of the 72 enrolled and treated participants, 67 were evaluable for the chronic effectiveness endpoint.||Successful participants|||Number
799691|NCT00958191|Secondary|Implant Survivorship||10 years||||||
799692|NCT00958191|Secondary|Lower Extremity Activity Scale (LEAS) Change|Change in the LEAS is reported by comparing the mean preoperative, 1,3 and 5 year scores. The LEAS is completed by the participant to assess activity level. Activity levels are ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level.|pre-operative, 1,3 and 5 years|A total of 240 hips were assessed preoperatively, 215 at 1 year, 152 at 3 years, and 131 at 5 years.||units on a scale|Hips|Standard Deviation|Mean
799693|NCT00958191|Primary|Incidence of Revision of Component for Any Reason|Revision of any component is defined as surgical removal and replacement of the femoral component, acetabular shell, acetabular insert and/or femoral head.|5 year|Difference of 5 participants from the participant flow completed (=110): 4 participants are included in the revision category of the participant flow and one participant had revision of only the femoral head & stem but later withdrew from the study & is included in the withdrawal category of the participant flow.||percentage of hips undergoing revision|Hips||Number
799694|NCT00958191|Secondary|SF-12 Health Survey Change|Change in the SF-12 score is reported by comparing the mean preoperative, 1,3 and 5 year postoperative scores.The SF-12 Health Survey is a 12-item patient completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.|pre-operative, 1,3 and 5 years|A total of 233 hips had preoperative SF-12 assessments, 211 had 1 year, 149 had 3 year, and 126 had 5 year SF-12 assessments.||units on a scale|Hips|Standard Deviation|Mean
799695|NCT00958191|Secondary|Harris Hip Score (HHS) Range of Motion (ROM) Change|"The change in HHS ROM is reported by comparing the mean preoperative, 1, 3 and 5 year postoperative scores. Scores can range from 0 (worst) to 5 (best). The degrees of motion are measured for hip flexion, abduction, adduction, external rotation and internal rotation. The measured values are added to determine a combined value that is associated with a score from 0 to 5.
211-300 degrees = 5 points
161 to 210 degrees = 4 points
101 to 160 degrees = 3 points
61 to 100 degrees = 2 points
31 to 60 degrees = 1 points
0 to 30 degrees = 0 points"|pre-operative, 1,3 and 5 years|A total of 240 hips had HHS ROM assessments preoperatively, 211 at the 1 year postoperative interval, 158 at the 3 year postoperative interval, and 122 at the 5 year postoperative interval.||units on a scale|Hips|Standard Deviation|Mean
799706|NCT00958243|Secondary|Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination|"UAE grading:
Grade 1: Symptoms were easily tolerated and did not interfere with daily activities.
Grade 2: Enough discomfort to cause some interference with daily activities. Grade 3: Symptoms that prevented normal, everyday activities."|During the 21 days after each vaccination|Safety Population comprised all randomized participants who received at least one dose of study vaccine and had provided follow-up safety data.||Percentage of participants|||Number
799696|NCT00958191|Secondary|Change in Harris Hip Score (HHS) Pain|"The change in HHS Pain is reported by comparing the mean preoperative, 1, 3 and 5 year postoperative pain scores. Scores can range from 0 to 44, with 0 indicating totally disabling pain and 44 indicating no pain or pain that is ignored.
None or ignores it = 44 points
Slight, occasional, no compromise in activities = 40 points
Mild pain, no effect on average activities, rarely moderate pain with unusual activity;may take aspirin = 30 points
Moderate pain, tolerable, but makes concessions to pain. Some limitation of ordinary activity or work. May require occasional pain medication stronger than aspirin = 20 points
Marked pain, serious limitation of activites = 10 points
Totally disabled, crippled, pain in bed, bedridden = 0 points"|pre-operative, 1,3, and 5 years|A total of 240 hips had HHS Pain assessments preoperatively, 217 at the 1 year postoperative interval, 168 at the 3 year postoperative interval, and 130 at the 5 year postoperative interval.||units on a scale|Hips|Standard Deviation|Mean
799697|NCT00958191|Secondary|Harris Hip Score (HHS) Change|"The change in HHS is reported by comparing the mean preoperative, 1, 3 and 5 year postoperative scores that assess pain, function, joint deformity and range of motion. Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score less than or equal to 79 is considered fair-poor.
90 - 100 = excellent
80 - 89 = good
70 - 79 = fair
0 - 69 = poor"|pre-opearative, 1,3 and 5 years|A total of 236 hips had HHS assessments preoperatively, 211 at the 1 year postoperative interval, 158 at the 3 year postoperative interval, and 121 at the 5 year postoperative interval.||units on a scale|Hips|Standard Deviation|Mean
799698|NCT00958191|Secondary|Radiographic Stability|Radiographic stability is defined as having all of the following: no radiographic indication of progressive radiolucent lines greater than or equal to 2 mm around the entire acetabular cup, no radiographic indication of acetabular cup migration of greater than or equal to 3 mm, no radiographic indication of progressive radiolucent lines greater than or equal to 2 mm around the entire femoral component, and no radiographic indication of progressive subsidence of the femoral component of greater than 5 mm. Radiographs are evaluated at 1,2,3,4 and 5 years.|1,2,3,4 and 5 years|A total of 214 hips had 1 year radiographs, 195 had 2 year, 166 had 3 year, 153 had 4 year and 137 had 5 year radiographs.||hips evaluated as unstable on radiograph|Hips||Number
799699|NCT00958191|Secondary|Volumetric Wear Rate of the Trident X3 Polyethylene Insert|Volumetric wear rate is calculated using a formula based on the cylindrical wear pattern perpendicular to the face of the cup and the mean linear wear rate.|3,4 and 5 years|There were 149 hips with 3 year radiographs, 134 with 4 year, and 118 with 5 year.||cubic mm/year|Hips||Number
799700|NCT00958191|Secondary|Linear Wear Rate of the Trident X3 Polyethylene Insert|Linear wear rates are defined as the annual rate of removal of the polyethylene from the polyethylene insert determined by comparing digitized images of serial radiographs obtained over the follow-up period.|3 and 4 years|A total of 149 hips were evaluated at 3 years and 134 at 4 years.||mm/year|Hips|Standard Deviation|Mean
799701|NCT00958191|Primary|Mean Linear Wear Rate at 5 Years|Linear wear rates are defined as the annual rate of removal of the polyethylene from the polyethylene insert determined by comparing digitized images of serial radiographs obtained over the follow-up period of 5 years|5 years|||mm/year|Hips|Standard Deviation|Mean
799702|NCT00958217|Primary|Timeline Followback|The Timeline Followback is a calendar-assisted structured interview that assesses the frequency of alcohol and drug use on a daily basis and the quantity of alcohol use. Summary proportion of days abstinent were calculated at each time point. Trajectory analyses examine two substance use outcomes: probability of any alcohol or drug use on a given day and probability of heavy drinking (5 or more drinks consumed in a day) on a given day. Trajectories of substance use (any alcohol or drug use on a particular day) and heavy drinking (>5 drinks on a particular day) were modeled as dichotomous outcomes, using logit links to predict the probability of substance use or heavy drinking on a particular day. Data Table reports starting proportion of days abstinent at time of randomization.|Assessed quarterly; trajectories analyzed from randomization through end of study (covering approximately 15 months)|||proportion of days abstinent||Standard Deviation|Mean
799703|NCT00958217|Primary|Posttraumatic Stress Disorder (PTSD) Symptoms|The Posttraumatic Stress Disorder Checklist - Civilian version (PCL-C) is a 17 item self-report checklist of PTSD symptoms experienced in the past month rated on a 1 (not at all) to 5 (extremely) scale; total score is summed from the item scores and range from 17 (none) to 85 (most severe). . Civilian version was selected as it allows for a variety of trauma types. Scores above 50 are considered clinical levels. We tested whether treatment group interacted with time to examine whether trajectories of symptom scores differed across treatment conditions. Linear mixed effects models were used to ascertain trajectories of total scores. This analytic approach was advantageous in that it provided examination of change in PTSD across all quarterly assessments. Models were estimated with maximum likelihood methods. Total score at the time of randomization is reported in Data Table and coefficient estimates for trajectories are reported in Statistical Analysis.|Assessed quarterly; trajectories analyzed total scores from randomization through end of study (6 timepoints covering approximately 15 months)|||units on a scale||Standard Deviation|Mean
799704|NCT00958217|Primary|Depression Symptoms Were Assessed With the Hamilton Depression Rating Scale.|Depression symptoms were assessed using a structured clinical interview assessment consisting of 21 items. Depression symptoms experienced in the past week are rated on a 0 (none) to 4 (most severe) scale. The total score is summed from the item scores and range from 0 (none) to 84 (most severe). We tested whether treatment group interacted with time in order to examine whether trajectories of symptom scores differed across treatment conditions. Linear mixed effects models were used to ascertain trajectories of total scores from randomization through end of study (6 timepoints across approximately 15 months). This analytic approach was advantageous in that it provided examination of change in depression across all quarterly assessments. Models were estimated with maximum likelihood methods. Total score at the time of randomization is reported in Data Table and coefficient estimates for trajectories are reported in Statistical Analysis.|Assessed quarterly; trajectories analyzed total scores from randomization through end of study (6 timepoints covering approximately 15 months)|||units on a scale||Standard Deviation|Mean
799705|NCT00958243|Secondary|Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset of Chronic Illness (NOCIs)|A NOCI was defined as the diagnosis of a new medical condition that was chronic in nature, including those potentially controllable by medication (e.g., diabetes, asthma).|Up to 180 days after the last vaccination|Safety Population comprised all randomized participants who received at least one dose of study vaccine and had provided follow-up safety data.||Percentage of participants|||Number
799707|NCT00958243|Secondary|Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B||During the 7 days after each study vaccination|Safety Population comprised all randomized participants who received at least one dose of study vaccine and had provided follow-up safety data. In Cohort B, Safety Population after the first vaccination are placebo group 28, 7.5 mcg group 107 and 15 mcg group 109; and 27, 105 and 103 respectively after the second vaccination.||Days||Standard Deviation|Mean
799708|NCT00958243|Primary|Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After Second Study Vaccination||21 days after the second study vaccination|The Evaluable Population (for the second vaccination) comprised all randomized participants who received the second study vaccine; provided both pre- and post-vaccination blood samples; were not excluded from analyses (e.g., the use of a prohibited medication or a laboratory confirmed infection with 2009 H1N1 between Visit 1 and Visit 3).||Percentage of participants||95% Confidence Interval|Number
799709|NCT00958243|Primary|Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After First Study Vaccination||21 days after the first study vaccination|The Evaluable Population (for the first vaccination) comprised all randomized participants who received the first study vaccine; provided both pre- and post-vaccination blood samples; were not excluded from analyses (e.g., the use of a prohibited medication or a laboratory confirmed infection with 2009 H1N1 between Visit 1 and Visit 3).||Percentage of participants||95% Confidence Interval|Number
799710|NCT00958243|Secondary|Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B|Grade 3 solicited AE definitions: Prevented normal daily activities or required medical intervention for systemic AEs; Prevented normal daily activities (aged >= 3 years)for injection site pain; Size > 30 mm for injection site redness and injection site induration/swelling; Oral temperature > 104.0°F (40.0°C) or axillary temperature > 103.1°F (39.5°C) for fevers.|During the 7 days after each study vaccination|Safety Population comprised all randomized participants who received at least one dose of study vaccine and had provided follow-up safety data.||Percentage of participants|||Number
799711|NCT00958243|Secondary|Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A||During the 7 days after each study vaccination|Safety Population comprised all randomized participants who received at least one dose of study vaccine and had provided follow-up safety data.In Cohort A, Safety Population after the first vaccination are placebo group 26, 7.5 mcg group 105 and 15 mcg group 96; and 25, 101 and 91 respectively after the second vaccination.||Days||Standard Deviation|Mean
799712|NCT00958243|Secondary|Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A|Grade 3 solicited AE definitions: Prevented normal daily activities or required medical intervention for systemic AEs; Cried when limb was moved/spontaneously painful (aged < 3 years) for injection site pain; Size > 30 mm for injection site redness and injection site induration/swelling; Oral temperature > 104.0°F (40.0°C) or axillary temperature > 103.1°F (39.5°C) for fevers.|During the 7 days after each study vaccination|Safety Population comprised all randomized participants who received at least one dose of study vaccine and had provided follow-up safety data.||Percentage of participants|||Number
799713|NCT00958243|Primary|Seroconversion Rate 21 Days After Second Study Vaccination|Seroconversion rate: the percentage of participants achieving seroconversion in HI antibody titer. Seroconversion is defined as participants with a pre-vaccination titer of less than 1:10 achieving a post-vaccination HI antibody titer of 1:40 or more; or participants with a pre-vaccination HI titer of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titer.|21 days after the second study vaccination|The Evaluable Population (for the second vaccination) comprised all randomized participants who received the second study vaccine; provided both pre- and post-vaccination blood samples; were not excluded from analyses (e.g., the use of a prohibited medication or a laboratory confirmed infection with 2009 H1N1 between Visit 1 and Visit 3).||Percentage of participants||95% Confidence Interval|Number
799714|NCT00958243|Primary|Seroconversion Rate 21 Days After First Study Vaccination|Seroconversion rate: the percentage of participants achieving seroconversion in HI antibody titer. Seroconversion is defined as participants with a pre-vaccination titer of less than 1:10 achieving a post-vaccination HI antibody titer of 1:40 or more; or participants with a pre-vaccination HI titer of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titer.|21 days after the first study vaccination|The Evaluable Population (for the first vaccination) comprised all randomized participants who received the first study vaccine; provided both pre- and post-vaccination blood samples; were not excluded from analyses (e.g., the use of a prohibited medication or a laboratory confirmed infection with 2009 H1N1 between Visit 1 and Visit 3).||Percentage of participants||95% Confidence Interval|Number
799715|NCT00958256|Primary|Response Rate|Response rate to regimen defined as the percentage of number of complete response or partial response in total number of participants treated. The response assessed after the first 2 cycles. Response (complete and partial remission) according to International Workshop Response Criteria for Non-Hodgkin's Lymphoma: A complete response is the complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A partial response is regression of measurable disease and no new sites of disease. Stable disease is failure to attain a complete response/partial response or progressive disease. A cycle is 21 days with 6-8 cycles administered depending on response.|Evaluation of disease after 2 cycles (approximately 6 weeks).|Twenty-one patients were evaluable for response assessment (100%), of whom 16 responded (76%) thus reflected are the percentage of responses to total responders (i.e. 11 (52%) of total evaluable achieved a complete response).||percentage of participants|||Number
799716|NCT00958282|Secondary|Drug Craving|"On a weekly basis, patients completed measures of cocaine craving using the Minnesota Cocaine Craving Scale.
The Minnesota Cocaine Craving Scale is a self report questionnaire and ranges from 0 to 100, 0 being very little to 100 being very much."|14 Weeks|||units on a scale||Standard Error|Mean
799717|NCT00958282|Primary|Cocaine-positive Urine Results|At each visit, subjects provided urine samples, which were analyzed for benzoylecgonine (BE; a cocaine metabolite). BE was assessed semi-quantitatively using the PROFILE® -V MEDTOXScan® Drugs of Abuse Test System, with cocaine positive tests equaling or exceeding 150 ng/mL.|14 Weeks|||percentage of BE urine tests||Standard Deviation|Mean
799718|NCT00958308|Secondary|Frequencies of Other Gastrointestinal Symptoms.|Episodes of gastrointestinal disorders during hospitalization were recorded by patient interview and were confirmed by review of patient diaries.|Up to 40 days||||||
799720|NCT00958308|Secondary|Frequency of Stool Samples Positive for Clostridium Difficile (C. Difficile) Toxin A and/or B.|If diarrhea occured while hospitalized, patients provided a stool sample for C. difficile analysis of Toxin A and/or B. All episodes were recorded by a nurse of clinician on a case report form using the seven-item Bristol Stool Form Scale (Riegler et al., 2001). A diarrhea episode was described as a bowel movement consisting of watery stool with or without solids.|Up to 40 days||||||
799721|NCT00958308|Secondary|Severity of AAD in Hospitalized Patients Ingesting BIO-K+CL1285® or Placebo.|Duration of diarrhea was determined by number of continuous days of diarrhea. Average number of liquid stools per day was determined by the sum of the number of liquid stools per day in the AAD episode divided by the duration of diarrhea in days.|Up to 40 days||||||
799722|NCT00958308|Primary|To Assess if Probiotic Prophylaxis (BIO-K+CL1285®) is Effective for the Prevention of AAD in Hospitalized Patients.|Incidence of AAD data were collected using questionnaire and diaries given to participants upon discharge. Diagnosis of AAD was made when a patient produced three or more liquid stools in a 24h period after antibiotic treatment with no other obvious reason for diarrhea.|Up to 40 days|||participants|||Number
799723|NCT00958334|Secondary|Change From Baseline of ZPU-003 Ext to 14 Months in Subject's Menstrual Pictograms(Subjects Evaluable for Menorrhagia Only)||baseline and 14 months||||||
799724|NCT00958334|Primary|The Change in Menorrhagia From the Baseline of ZPU-003 to the End of Each Off Drug Interval(ODI) Within the ZPU-003 Extension Study and the Baseline of ZPU-003 to the End of ZPU-003 Ext.|An ODI is defined as a time period of less than 3 months during which a return to menses occurs. All statistical endpoints will use the baseline of ZPU-003 Ext for 14-month data and baseline of ZPU-003 for 17-month data.|baseline, 14 months (3-4 cycles), 17 months|Intent to treat population||mL||Standard Deviation|Mean
799725|NCT00958347|Primary|Patients Will be Evaluated for Pain, Functional Level, and Clinical Complications Utilizing the Harris Hip Score.||25 Years Post-Operatively|The study was closed and no subjects reached the 25 year postoperative endpoint.|||||
799726|NCT00958360|Secondary|Comparison of Overall Visual Ability From Baseline to Four Months Later Measured With 48 Item VA Low Vision Visual Functioning Questionnaire|The range of scores for the Overall Visual Ability subscale of the VA Low Vision Visual Functioning Questionnaire is 0 to 3.5 logits (log odds ratio). A higher score indicates better ability or less difficulty performing activities.|changes from baseline to 4 months later|||logits||Standard Deviation|Mean
799727|NCT00958360|Secondary|Comparison of Changes in Visual Motor Skills From Baseline to Four Months Later Measured With 48 Item VA Low Vision Visual Functioning Questionnaire|The range of scores for the Visual Motor Skills subscale of the VA Low Vision Visual Functioning Questionnaire is 0 to 3.5 logits (log odds ratio). A higher score indicates better ability or less difficulty performing activities.|changes from baseline to 4 months later|||logits||Standard Deviation|Mean
799728|NCT00958360|Secondary|Comparison of Changes in Visual Information Processing From Baseline to Four Months Later Measured With 48 Item VA Low Vision Visual Functioning Questionnaire|The range of scores for the Visual Information Processing subscale of the VA Low Vision Visual Functioning Questionnaire is 0 to 3.5 logits (log odds ratio). A higher score indicates better ability or less difficulty performing activities.|changes from baseline to 4 months later|||logits||Standard Deviation|Mean
799729|NCT00958360|Secondary|Comparison of Changes in Mobility From Baseline to Four Months Later Measured With 48 Item VA Low Vision Visual Functioning Questionnaire|The range of scores for the Mobility subscale of the VA Low Vision Visual Functioning Questionnaire is 0 to 3.5 logits (log odds ratio). A higher score indicates better ability or less difficulty performing activities.|changes from baseline to 4 months later|||logits||Standard Deviation|Mean
799730|NCT00958360|Primary|Comparison of Changes in Visual Reading Ability From Baseline to Four Months Later Measured With 48 Item VA Low Vision Visual Functioning Questionnaire|The range of scores for the Visual Reading Ability subscale of the VA Low Vision Visual Functioning Questionnaire is 0 to 3.5 logits (log odds ratio). A higher score indicates better ability or less difficulty performing activities.|changes from baseline to 4 months later|||logits||Standard Deviation|Mean
799731|NCT00958438|Secondary|Number of Gout Flare Days With Participant's Pain Score of 5 or More (From Daily Diary) Per Participant From Day 1 to Day 113 (Week 16)|Participants were asked to complete a telephone diary by calling the IVRS daily beginning at the baseline visit (Day 1) through the follow-up visit (Day 141) and reported their general well-being, gout symptoms, and weekly study drug administrations. At the onset of pain from a gout flare, participants were to answer additional diary questions regarding their gout flare and had to continue daily flare assessments until they reported the flare had ended. If a flare occurred just prior to the follow-up visit (Day 141), participants were to continue completing the daily diary until the flare resolved. Gout flare pain was assessed on a scale from 0 to 10 (with 0=no pain and 10=severe pain) within the past 24 hours.|Day 1 to Day 113 (Week 16)|FAS that included all randomized participants who received any study medication, and was based on the treatment allocated by IVRS at randomization (as randomized). Here, number of participants analyzed=participants with available data for this endpoint.||Gout flare days||Standard Deviation|Mean
799732|NCT00958438|Secondary|Number of Gout Flare Days Per Participant From Day 1 to Day 113 (Week 16)|Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain, and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Number of gout flare days per participant was reported for this outcome measure.|Day 1 to Day 113 (Week 16)|FAS that included all randomized participants who received any study medication, and was based on the treatment allocated by the IVRS at randomization (as randomized). Here, number of participants analyzed=participants with available data for this endpoint.||Gout flare days||Standard Deviation|Mean
799733|NCT00958438|Secondary|Percentage of Participants With at Least Two Flares From Day 1 to Day 113 (Week 16)|Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain, and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Percentage of participants with at least two gout flares was reported for this outcome measure.|Day 1 to Day 113 (Week 16)|FAS that included all randomized participants who received any study medication, and was based on the treatment allocated by the IVRS at randomization (as randomized).||percentage of participants|||Number
799734|NCT00958438|Secondary|Percentage of Participants With at Least One Flare From Day 1 to Day 113 (Week 16)|Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain; and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Percentage of participants with at least one gout flare was reported for this outcome measure.|Day 1 to Day 113 (Week 16)|FAS that included all randomized participants who received any study medication, and was based on the treatment allocated by the IVRS at randomization (as randomized).||percentage of participants|||Number
799735|NCT00958438|Secondary|Number of Modified Gout Flares Per Participant From Day 1 to Day 113 (Week 16)|Modified gout flare was defined using modified definition of a gout flare as participant-reported articular pain typical of a gout attack that was deemed to require treatment with anti-inflammatory therapy. Number of modified gout flares per participant were reported for this outcome measure.|Day 1 to Day 113 (Week 16)|FAS that included all randomized participants who received any study medication, and was based on the treatment allocated by the IVRS at randomization (as randomized). Here, number of participants analyzed=participants with available data for this endpoint.||Gout flares||Standard Deviation|Mean
799736|NCT00958438|Primary|Number of Gout Flares Per Participant Assessed From Day 1 to Day 113 (Week 16)|Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Number of gout flares per participant was reported for this outcome measure.|Day 1 to Day 113 (Week 16)|Full analysis set (FAS) that included all randomized participants who received any study medication, and was based on the treatment allocated by the Interactive voice response system (IVRS) at randomization (as randomized). Here, number of participants analyzed=participants with available data for this endpoint.||Gout flares||Standard Deviation|Mean
799737|NCT00958477|Secondary|Minimum Percent Change From Baseline in PSA Level|Minimum percent change from Baseline in PSA Level during the study was reported.|Baseline up to 394 days|Efficacy analysis set included all subjects who received at least 1 dose of the study drug.||percent change||Standard Deviation|Mean
799738|NCT00958477|Secondary|Maximum Percent Change From Baseline in Prostate Specific Antigen (PSA) Level|Maximum percent change from Baseline in PSA Level during the study was reported.|Baseline up to 394 days|Efficacy analysis set included all subjects who received at least 1 dose of the study drug.||percent change||Standard Deviation|Mean
799739|NCT00958477|Secondary|Total Pain Score Using Brief Pain Inventory-Short Form (BPI-sf)|"BPI-sf is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions. BPI-sf has 4 questions that assess pain intensity (worst, least, average, right now) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each question is answered on a scale ranging from 0 to 10;‘0=No pain and 10=Pain as bad as you can imagine’.Total score is reported as average of individual questions ranges from 0 to 10, with lower scores being indicative of less pain or pain interference.Data was not available for EMD 525797 250 mg arm for FUP Weeks 15, 19, 23, 27, 31, 35, 39, 43, 47, 51, 55, 59, 63, 67, 71, 75 and EMD 525797 1000 mg arm for FUP Weeks 47, 51, 55, 59, 63, 67, 71 and EMD 525797 1500 mg arm for FUP Weeks 35, 39, 43, 47, 51, 55, 59, 63, 67, 71, 75 respectively as no subjects were evaluable at the specified FUP visits."|Screening; Baseline; Week 3, 5, 7; Follow-up (FUP) Week 11, 15, 19, 23, 27, 31, 35, 39, 43, 47, 51, 55, 59, 63, 67, 71, 75; End of treatment (EOT; maximum up to 380 days) and EOS (maximum up to 394 days)|"Efficacy analysis set included all subjects who received at least 1 dose of the study drug. Here n signifies those subjects who were evaluable for this outciome measure at the specified time points."||score on a scale||Standard Deviation|Mean
799740|NCT00958477|Secondary|Number of Subjects With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score vs. Best Post-baseline Score|ECOG performance status measured to assess subject’s performance status on a scale of 0 to 4, where 0=Fully active, able to carry on all pre-disease activities without restriction; 1=Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; 2=Ambulatory (>50% of waking hours), capable of all self-care, unable to carry out any work activities; 3=Capable of only limited self-care, confined to bed/chair >50% of waking hours; 4=Completely disabled, cannot carry on any self-care, totally confined to bed/chair. ECOG performance status was reported in terms of number of subjects with Baseline value vs. best post-baseline value (i.e. lowest score) combination.|Baseline up to 394 days|Safety analysis set included all subjects who received at least 1 dose of the study medication and had at least 1 follow-up safety measure.||subjects|||Number
799741|NCT00958477|Secondary|Number of Subjects With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score vs. Worst Post-baseline Score|ECOG performance status measured to assess subject’s performance status on a scale of 0 to 4, where 0=Fully active, able to carry on all pre-disease activities without restriction; 1=Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; 2=Ambulatory (>50% of waking hours), capable of all self-care, unable to carry out any work activities; 3=Capable of only limited self-care, confined to bed/chair >50% of waking hours; 4=Completely disabled, cannot carry on any self-care, totally confined to bed/chair. ECOG performance status was reported in terms of number of subjects with Baseline value vs. worst post-baseline value (i.e. highest score) combination.|Baseline up to 394 days|Safety analysis set included all subjects who received at least 1 dose of the study medication and had at least 1 follow-up safety measure.||subjects|||Number
799742|NCT00958477|Secondary|Time to Progression (TTP)|TTP was calculated as the time between the date of imaging for the earliest visit where progressive disease was detected and the first dose date plus 1 day. Participants without event are censored on the date of last tumor assessment.|Baseline up to disease progression up to a maximum of 13.1 months|Efficacy analysis set included all subjects who received at least 1 dose of the study drug. Here “Number of Participants” analyzed signifies those subjects who were evaluable for this outcome measure.||months|||Number
799890|NCT00959751|Primary|Headache Relief (Modified LOCF - Efficacy Evaluable Analysis Set)|Headache relief at 2 hours post administration defined as reduction from Baseline moderate or severe score to mild or none.|2 hours|Modified LOCF - Efficacy Evaluable Analysis Set||Participants|||Number
799743|NCT00958477|Secondary|Progression-free Survival (PFS) as Per Prostate Cancer Clinical Trials Working Group 1 (PCWG1) and Prostate Cancer Clinical Trials Working Group 2 (PCWG2) Criteria|PFS PCWG1 criteria: time from the day treatment is initiated up to progression (for subject’s whose prostate specific antigen [PSA] level did not decrease after baseline, progression defined as 50% PSA increase relative to baseline; for subject’s whose PSA decreased after baseline, progression defined as 50% PSA increase relative to nadir [smallest PSA value post-baseline]. Progression was confirmed if progression criterion was met in next 2 assessments as well.) PFS PCWG2 criteria: time from study entry to disease progression or death. Progression was defined as first appearance of progression according to PSA (for subject’s whose PSA decreased after baseline, progression was defined as 25% PSA increase relative to nadir. Progression was confirmed if another assessment measured at least 3 weeks later met the criterion as well; for subject’s whose PSA did not decrease after baseline, progression was defined as 25% PSA increase relative to baseline assessed 12 weeks after baseline).|Baseline up to 394 days|Efficacy analysis set included all subjects who received at least 1 dose of the study drug.||months||95% Confidence Interval|Median
799744|NCT00958477|Secondary|Number of Subjects With Best Overall Response (BOR)|Number of subjects with BOR in each category (complete response [CR], partial response [PR], stable disease [SD], progressive disease [PD]) according to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0) was reported. CR: defined as disappearance of all target and all non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: defined as at least a 30% decrease in sum of longest diameter of target lesions, taking as reference the baseline sum of longest diameter. PD:defined as at least a 20% increase in sum of longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or unequivocal progression of existing non-target lesions. SD: defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of longest diameter while on study.|Week 6, Week 19, Overall (Baseline Up to 394 days)|Efficacy analysis set included all subjects who received at least 1 dose of the study drug.||subjects|||Number
799745|NCT00958477|Secondary|Accumulation Ratio of AUC (R_AUC)|Accumulation ratio for AUC, calculated as area under the serum concentration-time curve within one complete dosing interval at third dose divided by area under the serum concentration-time curve within one complete dosing interval at first dose.|pre-dose, end of infusion, 4, 8, 24, 48, 96,168 hours post-infusion at Week 1 and pre-dose, end of infusion, 4, 8, 24, 48, 96, 168, 336 hours post third infusion at Week 5|PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here “Number of Participants analyzed” signifies those subjects who were evaluable for this outcome measure for each arm, respectively.||ratio||Geometric Coefficient of Variation|Geometric Mean
799746|NCT00958477|Secondary|Accumulation Ratio Of Cmax (R_Cmax)|Accumulation ratio for Cmax was calculated as Cmax, after third dose/Cmax, after first dose.|pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 1 and Week 5|PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here “Number of Participants analyzed” signifies those subjects who were evaluable for this outcome measure for each arm, respectively.||ratio||Geometric Coefficient of Variation|Geometric Mean
799747|NCT00958477|Secondary|Apparent Volume of Distribution at Steady State (Vss) of EMD 525797 After Third Infusion|Apparent volume of distribution at steady-state was reported. Apparent volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug.|pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 5|PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here “Number of Participants analyzed” signifies those subjects who were evaluable for this outcome measure for each arm, respectively.||Liters||Geometric Coefficient of Variation|Geometric Mean
799748|NCT00958477|Secondary|Mean Residence Time of Drug in the Body (MRT) of EMD 525797 After First Infusion|Mean residence time of drug in the body calculated as: AUMC0-inf / AUC0-inf, where AUMC0-inf is the area under the first moment curve from time zero to infinity. Where AUC0-inf is area under the serum concentration time curve from time zero to infinity, calculated as AUC0 t + AUCextra. AUCextra represents an extrapolated value obtained by Clast/λz, where Clast is the calculated serum concentration at the last sampling time point at which the measured serum concentration is at or above lower limit of quantification (LLQ) and λz is elimination rate constant.|pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 1|"PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here Number of Participants analyzed signifies those subjects who were evaluable for this outcome measure for each arm, respectively."||hours||Geometric Coefficient of Variation|Geometric Mean
799749|NCT00958477|Secondary|Peak Trough Fluctuation Over One Dosing Interval at Steady State (%PTF) of EMD 525797 After Third Infusion|The peak trough fluctuation over one dosing interval at steady state, calculated as PTF (%) = ( [ Cmax - Cmin ] / Cav )*100|pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 5|PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here “Number of Participants analyzed” signifies those subjects who were evaluable for this outcome measure for each arm, respectively.||percentage of fluctuation||Geometric Coefficient of Variation|Geometric Mean
799762|NCT00958477|Primary|Trough Serum Concentration (Ctrough) Of EMD 525797 at Week 5|Ctrough is the concentration prior to study drug administration.|pre-dose at Week 5|PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here “Number of Participants analyzed” signifies those subjects who were evaluable for this outcome measure for each arm, respectively.||mcg/mL||Standard Deviation|Mean
799891|NCT00959764|Secondary|Change in Plasma CTx-1 From Baseline|Percent change from baseline of plasma CTx-1 at end of study=48 weeks|48 weeks|Modified Intent-to-Treat Population||Percentage change from baseline||Standard Deviation|Least Squares Mean
799750|NCT00958477|Secondary|Area Under the Serum Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of EMD 525797 After First Infusion|Area under the serum concentration time curve from time zero to infinity, calculated as AUC0 t + AUCextra. AUCextra represents an extrapolated value obtained by Clast/λz, where Clast is the calculated serum concentration at the last sampling time point at which the measured serum concentration is at or above LLQ and λz is elimination rate constant.|pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 1|"PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here Number of Participants analyzed signifies those subjects who were evaluable for this outcome measure for each arm, respectively."||h*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
799751|NCT00958477|Secondary|Area Under the Serum Concentration-time Curve Within One Complete Dosing Interval (AUCtau) of EMD 525797 After Third Infusion|Area under the concentration-time curve from time zero up to time Tau, where Tau is the dosing interval (336 hours).|pre-dose, end of infusion, 4, 8, 24, 48, 96,168, 336 hours post third infusion at Week 5|PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here “Number of Participants analyzed” signifies those subjects who were evaluable for this outcome measure for each arm, respectively.||h*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
799752|NCT00958477|Secondary|Area Under the Serum Concentration-time Curve Within One Complete Dosing Interval (AUCtau) of EMD 525797 After First Infusion|Area under the concentration-time curve from time zero up to time Tau, where Tau is the dosing interval (168 hours).|pre-dose, end of infusion, 4, 8, 24, 48, 96 and 168 hours post-infusion at Week 1|"PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here Number of Participants analyzed signifies those subjects who were evaluable for this outcome measure for each arm, respectively."||h*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
799753|NCT00958477|Secondary|Average Serum Concentration at Steady State (Cav) of EMD 525797 After Third Infusion|The average serum concentration at steady state, calculated as Cav = AUCtau/tau, where tau is the dosing interval (336 hours).|pre-dose, end of infusion, 4, 8, 24, 48, 96, 168, 336 hours post third infusion at Week 5|PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here “Number of Participants analyzed” signifies those subjects who were evaluable for this outcome measure for each arm, respectively.||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
799754|NCT00958477|Secondary|Observed Minimum Serum Concentration (Cmin) of EMD 525797 After Third Infusion|Observed minimum serum concentration determined directly from the serum concentration-time profile of each subject.|pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 5|PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here “Number of Participants analyzed” signifies those subjects who were evaluable for this outcome measure for each arm, respectively.||mcg/mL||Standard Deviation|Mean
799755|NCT00958477|Secondary|Elimination Rate Constant (λz) of EMD 525797 After First Infusion|Elimination rate constant obtained from linear regression of the terminal phase of the log transformed concentration-time data.|pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 1|"PK analysis set included all subjects who received at least first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here Number of Participants analyzed signifies those subjects who were evaluable for this outcome measure for each arm, respectively."||1/h||Geometric Coefficient of Variation|Geometric Mean
799756|NCT00958477|Secondary|Apparent Terminal Half-life (t1/2) of EMD 525797 After First Infusion|Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life is calculated by dividing the natural logarithm to the base e (Log e) multiplied by (*) 2/ λz, where ‘λz’ is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.|pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 1|"PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here Number of Participants analyzed signifies those subjects who were evaluable for this outcome measure for each arm, respectively."||hours||Full Range|Median
799757|NCT00958477|Secondary|C-Reactive Protein Levels||Week 1 up to a maximum of 56 days|As per change in planned analysis, it was decided that that the biomarker analysis were not significantly associated with compound administration and thus the data was not collected for this outcome.|||||
799758|NCT00958477|Secondary|Serum Levels of Interleukin 6 (IL-6) and Interleukin 8 (IL-8)||Week 1 up to a maximum of 56 days|As per change in planned analysis, it was decided that that the biomarker analysis were not significantly associated with compound administration and thus the data was not collected for this outcome.|||||
799759|NCT00958477|Secondary|Number of Subjects With Positive Anti-EMD 525797 Antibodies||Week 1, 3, 5, 8, 9|Safety analysis set included all subjects who received at least 1 dose of the study medication and had at least 1 follow-up safety measure.||Subjects|||Number
799760|NCT00958477|Secondary|Time to Reach Observed Serum Concentration (Tmax) After Third Infusion||pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 5|PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here “Number of Participants analyzed” signifies those subjects who were evaluable for this outcome measure for each arm, respectively.||hours||Full Range|Median
799761|NCT00958477|Secondary|Time to Reach Observed Serum Concentration (Tmax) After First Infusion||pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 1|"PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here Number of Participants analyzed signifies those subjects who were evaluable for this outcome measure for each arm, respectively."||hours||Full Range|Median
810872|NCT01056315|Secondary|Change From Baseline of the Weekly Mean of Night Pain Intensity (on an 11-point NRS).||Baseline; weekly mean||||||
799763|NCT00958477|Primary|Trough Serum Concentration (Ctrough) Of EMD 525797 at Week 3|Ctrough is the concentration prior to study drug administration.|pre-dose at Week 3|PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here “Number of Participants analyzed” signifies those subjects who were evaluable for this outcome measure for each arm, respectively.||mcg/mL||Standard Deviation|Mean
799764|NCT00958477|Primary|Trough Serum Concentration (Ctrough) Of EMD 525797 at Week 1|Ctrough is the concentration prior to study drug administration.|pre-dose at Week 1|PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here “Number of Participants analyzed” signifies those subjects who were evaluable for this outcome measure for each arm, respectively.||mcg/mL||Standard Deviation|Mean
799765|NCT00958477|Primary|Apparent Volume of Distribution During Terminal Phase (Vz) of EMD 525797 After First Infusion|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution during the terminal phase, calculated as = Dose/(AUC0-inf *λz) after first infusion. Where ‘λz’ is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Where AUC0-inf is area under the serum concentration time curve from time zero to infinity, calculated as AUC0 t + AUCextra. AUCextra represents an extrapolated value obtained by Clast/λz, where Clast is the calculated serum concentration at the last sampling time point at which the measured serum concentration is at or above lower limit of quantification (LLQ) and λz is elimination rate constant.|pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 1|"PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here Number of Participants analyzed signifies those subjects who were evaluable for this outcome measure for each arm, respectively."||Liters||Geometric Coefficient of Variation|Geometric Mean
799766|NCT00958477|Primary|Total Body Clearance of Drug From Serum (CL) After First Infusion|Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Total body clearance of drug from serum, calculated as CL = dose/AUC0-inf. Where AUC0-inf is area under the serum concentration time curve from time zero to infinity, calculated as AUC0 t + AUCextra. AUCextra represents an extrapolated value obtained by Clast/λz, where Clast is the calculated serum concentration at the last sampling time point at which the measured serum concentration is at or above lower limit of quantification (LLQ) and λz is elimination rate constant.|pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 1|"PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here Number of Participants analyzed signifies those subjects who were evaluable for this outcome measure for each arm, respectively."||L/h||Geometric Coefficient of Variation|Geometric Mean
799767|NCT00958477|Primary|Area Under the Serum Concentration-time Curve From Time Zero to the Last Sampling Time (AUC0-t) After First Infusion|Area under the serum concentration-time curve from time zero to the last sampling time at which the concentration is at or above lower limit of quantification (LLQ). AUC0-t was calculated according to the mixed log linear trapezoidal rule.|pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 1|"PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here Number of Participants analyzed signifies those subjects who were evaluable for this outcome measure for each arm, respectively."||h*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
799768|NCT00958477|Primary|Observed Maximum Serum Concentration (Cmax) of EMD 525797 After Third Infusion||pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 5|"PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here Number of Participants analyzed signifies those subjects who were evaluable for this outcome measure for each arm, respectively."||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
799769|NCT00958477|Primary|Observed Maximum Serum Concentration (Cmax) of EMD 525797 After First Infusion||pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 1|"Pharmacokinetic (PK) analysis set included all subjects who received at least first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797.Here Number of Participants analyzed signifies those subjects who were evaluable for this outcome measure for each arm, respectively."||microgram per milliliter (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
799770|NCT00958477|Primary|Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Related TEAEs|An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent are events between first dose of study drug that were absent before treatment or that worsened relative to pre-treatment state. TEAEs include both Serious TEAEs and non-serious TEAEs.Treatment-related are events which had causal relationship to study drug as assessed by the Investigator and were suspected to be reasonably related to the study drug.|Baseline up to 534 days|Safety analysis set included all subjects who received at least 1 dose of the study medication and had at least 1 follow-up safety measure.||Subjects|||Number
799782|NCT00958568|Secondary|Mean Change From Week 20 to Week 47 in Fasting Triglycerides|Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and standard error (SE). LS Mean values were controlled for baseline (Week 20), treatment, country, visit, and treatment by visit interaction.|Randomization (Week 20), Week 47|All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) triglycerides measurement.||milligrams/deciliter (mg/dL)||Standard Error|Least Squares Mean
812454|NCT01070784|Primary|Clinical Laboratory Test: Clinical Chemistry- S-Urea Nitrogen|Change from baseline|Baseline and 52 week after|||mg/dL||Standard Deviation|Mean
799771|NCT00958477|Primary|Number of Subjects With Dose Limiting Toxicity (DLT)|DLT was defined using National Cancer Institute Common Toxicity Criteria for Adverse Events Version 3.0 as any Grade 3 or 4 hematological or non-hematological toxicity occurring at any dose level until the end of Week 6, and suspected to be reasonably related to the investigational product by the Investigator and/or Sponsor except for allergic/ hypersensitivity reactions and any Grade 3/4 out-of-range laboratory values without any clinical correlate, which were reversible within 7 days.|Baseline up to 6 weeks|DLT analysis set: all subjects who experienced any DLT during first 6 weeks, regardless of number of doses of drug administered or who were considered completers (did not discontinue treatment for any reason other than DLT, were compliant, did not deviate in drug administration for more than +/-2 days due to any reason other than related toxicity).||subjects|||Number
799772|NCT00958568|Other Pre-specified|Kaplan-Meier Estimate of Percentage of Subjects Not Relapsing at Week 27 (Day 189)|Relapse is defined as meeting any of the following criteria (Relapse-any reason): 50% increase in MADRS score from randomization with concomitant CGI-S of Depression score increase to a score of 4 or more (MADRS score/CGI-S Depression Score); Hospitalization for depression or suicidality; Discontinuation due to lack of efficacy/worsening of depression/suicidality. MADRS is a rating scale for severity of depressive mood symptoms with 10 items rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). CGI-S measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (the most extremely ill). Lack of Efficacy/Worsening of depression was at the discretion of the investigator and based on clinical observation. Suicidality is thoughts or actions of self-harm as determined by the investigator.|Randomization (Week 20) to Week 27|All randomized participants.||percentage of participants||95% Confidence Interval|Number
799773|NCT00958568|Secondary|Percent of Participants With a 60 Milliseconds (Msec) Increase in Fridericia-Corrected (for Rate) Cardiac QT Interval (QTcF) on Electrocardiogram||Randomization (Week 20) to Week 47|All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) electrocardiogram (ECG) measurements.||percentage of participants|||Number
799774|NCT00958568|Secondary|Percent of Participants With Treatment-Emergent Corrected (for Rate) Cardiac QT Interval Using Fridericia's Formula (QTcF) on Electrocardiogram ≥500 Milliseconds (Msec)|Data presented are the percent of participants whose baseline corrected (for rate) cardiac QT interval <500 msec with post-baseline corrected (for rate) cardiac QT interval ≥500 msec.|Randomization (Week 20) to Week 47|All randomized participants who had <500 msec QTc interval at baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) electrocardiogram (ECG) measurements.||percentage of participants|||Number
799775|NCT00958568|Secondary|Mean Change in Corrected (for Rate) Cardiac QT Interval Using Fridericia’s Formula (QTcF) on Electrocardiogram|Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes baseline (Week 20), treatment, country, visit, and treatment by visit interaction.|Randomization (Week 20), Week 47|All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) electrocardiogram (ECG) measurements.||milliseconds (msec)||Standard Error|Least Squares Mean
799776|NCT00958568|Secondary|Percent of Participants With Suicide-Related Thoughts and Behaviors|"Columbia Suicide Rating Scale (C-SSRS) captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal ideation: a yes answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Suicidal behavior: a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide."|Randomization (Week 20) to Week 47|All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) C-SSRS measurements.||percentage of participants|||Number
799777|NCT00958568|Secondary|Percent of Participants With Week 20-to-Week 47 Endpoint Increase in Weight of at Least 7%||Week 20 to Week 47|All randomized participants who had Week 20 and at least 1 post-baseline (Weeks 21-47) weight measurements.||percentage of participants|||Number
799778|NCT00958568|Secondary|Mean Change From Week 20 to Week 47 in Weight|Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and standard error (SE). LS Mean values were controlled for baseline (Week 20), treatment, country, visit, and treatment by visit interaction.|Randomization (Week 20), Week 47|All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) weight measurements.||kilograms (kg)||Standard Error|Least Squares Mean
799779|NCT00958568|Secondary|Percent of Participants With Treatment-Emergent High Fasting Glucose|Impaired to High fasting glucose: ≥100 milligrams/deciliter (mg/dL) and <126 mg/dL at baseline and ≥126 mg/dL any time post baseline; Normal to High glucose: <100 mg/dL at baseline and ≥126 mg/dL any time post baseline; Normal to Impaired fasting glucose is <100 mg/dL at baseline, ≥100 mg/dL and <126 mg/dL any time post baseline; Normal/Impaired to High fasting glucose: <126 mg/dL at baseline and ≥126 mg/dL any time post baseline.|Randomization (Week 20) to Week 47|All randomized participants who had impaired or normal glucose value at baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) glucose measurements.||percentage of participants|||Number
799780|NCT00958568|Secondary|Mean Change From Week 20 to Week 47 in Fasting Glucose|Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and standard error (SE). LS Mean values were controlled for baseline (Week 20), treatment, country, visit, and treatment by visit interaction.|Randomization (Week 20), Week 47|All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) glucose measurements.||milligrams/deciliter (mg/dL)||Standard Error|Least Squares Mean
799781|NCT00958568|Secondary|Percent of Participants With Treatment-Emergent High Fasting Triglycerides|Borderline to High fasting triglycerides: ≥150 milligrams/deciliter (mg/dL) and <200 mg/dL at baseline and ≥200 mg/dL any time post baseline; Normal to Borderline fasting triglycerides: <150 mg/dL at baseline, ≥150 mg/dL and <200 mg/dL any time post baseline; Normal to High fasting triglycerides: <150 mg/dL at baseline and ≥200 mg/dL any time post baseline.|Randomization (Week 20) to Week 47|All randomized participants who had borderline or normal triglycerides value at baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) triglyceride measurements.||percentage of participants|||Number
799804|NCT00958568|Secondary|Time to Relapse as Measured by Hospitalization for Depression or Suicidality|"Those who did not relapse were censored at their last observation."|Randomization (Week 20) to Week 47|All randomized participants are included in the time to event analyses. The numbers of participants censored are 217 and 220 for OFC and Flu groups, respectively.||days||Full Range|Median
799783|NCT00958568|Secondary|Percent of Participants With Treatment-Emergent Hepatic Events|Participants with alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <=3 times the upper limit of normal (ULN) at baseline, with ALT or AST >=3 times the ULN post-baseline and total bilirubin >=2 times ULN at the same time are considered having treatment-emergent hepatic events.|Randomization (Week 20) to Week 47|All randomized participants who had baseline (Week 20) and post-baseline (Weeks 21-47) hepatic function measurements.||percentage of participants|||Number
799784|NCT00958568|Secondary|Percent of Participants With Treatment-Emergent Low Fasting High-Density Lipoprotein (HDL) Cholesterol|Normal to Low fasting HDL cholesterol is ≥40 milligrams/deciliter (mg/dL) at baseline and <40 mg/dL anytime post baseline.|Randomization (Week 20) to Week 47|All randomized participants who had normal HDL cholesterol value at baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) HDL cholesterol measurements.||percentage of participants|||Number
799785|NCT00958568|Secondary|Mean Change From Week 20 to Week 47 in Fasting High-Density Lipoprotein (HDL) Cholesterol|Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and standard error (SE). LS Mean values were controlled for baseline (Week 20), treatment, country, visit, and treatment by visit interaction.|Randomization (Week 20), Week 47|All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) HDL cholesterol measurements.||milligrams/deciliter (mg/dL)||Standard Error|Least Squares Mean
799786|NCT00958568|Secondary|Percent of Participants With Treatment-Emergent High Fasting Low-Density Lipoprotein (LDL) Cholesterol|Borderline to High fasting LDL cholesterol: ≥100 milligrams/deciliter (mg/dL) and <160 mg/dL at baseline and ≥160 mg/dL any time post baseline; Normal to Borderline fasting LDL cholesterol: <100 mg/dL at baseline, ≥100 mg/dL and <160 mg/dL any time post baseline; Normal to High fasting LDL cholesterol: <100 mg/dL at baseline and ≥160 mg/dL any time post baseline.|Randomization (Week 20) to Week 47|All randomized participants who had borderline or normal LDL cholesterol value at baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) LDL cholesterol measurements.||percent of participants|||Number
799787|NCT00958568|Secondary|Mean Change From Week 20 to Week 47 in Fasting Low-Density Lipoprotein (LDL) Cholesterol|Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and standard error (SE). LS Mean values were controlled for baseline (Week 20), treatment, country, visit, and treatment by visit interaction.|Randomization (Week 20), Week 47|All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) LDL cholesterol measurements.||milligrams/deciliter (mg/dL)||Standard Error|Least Squares Mean
799788|NCT00958568|Secondary|Percent of Participants With Treatment-Emergent High Fasting Total Cholesterol|Borderline to High fasting total cholesterol: ≥200 milligrams/deciliter (mg/dL) and <240 mg/dL at baseline and ≥240 mg/dL any time post baseline; Normal to Borderline fasting total cholesterol: <200 mg/dL at baseline, ≥200 mg/dL and <240 mg/dL any time post baseline; Normal to High fasting total cholesterol: <200 mg/dL at baseline and ≥240 mg/dL any time post baseline.|Randomization (Week 20) to Week 47|All randomized participants who had borderline or normal cholesterol level at baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) cholesterol measurements.||percentage of participants|||Number
799789|NCT00958568|Secondary|Mean Change From Week 20 to Week 47 in Fasting Total Cholesterol|Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and standard error (SE). LS Mean values were controlled for baseline (Week 20), treatment, country, visit, and treatment by visit interaction.|Randomization (Week 20), Week 47|All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) cholesterol measurements.||milligrams/deciliter (mg/dL)||Standard Error|Least Squares Mean
799790|NCT00958568|Secondary|Percent of Participants With Treatment-Emergent Dyskinesia|Abnormal Involuntary Movement Scale (AIMS) is a 12-item scale designed to record the occurrence of dyskinetic movements. Items 1 through 10 are rated on a 5-point scale, with 0 being no dyskinetic movements and 4 being severe dyskinetic movements. Items 11 and 12 are yes/no questions regarding the dental condition of the participants. Treatment emergent dyskinesia is defined as a score ≥3 on any one of the AIMS items 1-7 post-baseline (Weeks 21-47) or scores ≥2 on any two of the AIMS items 1-7 post-baseline (Weeks 21-47) among participants without either criteria at baseline (Week 20).|Randomization (Week 20) to Week 47|All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) AIMS measurements.||percentage of participants|||Number
799791|NCT00958568|Secondary|Percent of Participants With Treatment-Emergent Parkinsonism|Simpson-Angus Scale is used to measure Parkinsonian-type symptoms in participants exposed to neuroleptics. The scale consists of 10 items, each rated on a 5-point scale, with 0 meaning complete absence of the condition and 4 meaning the presence of the condition in extreme form. The total score is obtained by adding the items and ranges from 0-40 with higher scores indicating worse conditions. Treatment emergent parkinsonism is defined as total score ≤3 of items 1 through 10 of the Simpson-Angus scale at baseline (Week 20) and a total score >3 of items 1 through 10 post-baseline (Weeks 21-47).|Randomization (Week 20) to Week 47|All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) Simpson-Angus Scale measurements.||percentage of participants|||Number
799792|NCT00958568|Secondary|Percent of Participants With Treatment-Emergent Akathisia|Barnes Akathisia Scale (BAS) rates observable, restless movements of drug-induced akathisia as well as the subjective awareness of restlessness and any distress associated with the akathisia. It consists of 4 items. 3 items (objective akathisia, subjective awareness of restlessness and subjective distress related to restlessness) rated on a 4-point scale, with 0 being no akathisia and 3 being severe akathisia. Item 4 (global clinical assessment of Akathisia) is derived from the responses on Items 1-3 rated on a 6-point scale, with 0 being absence and 5 being extreme Akathisia. Treatment emergent akathisia is defined as a global clinical assessment score on BAS <2 at baseline (Week 20) and a global clinical assessment score on BAS ≥2 post-baseline (Weeks 21-47).|Randomization (Week 20) to Week 47|All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) BAS measurements.||percentage of participants|||Number
799815|NCT00958776|Other Pre-specified|Incidence of Influenza-Related Complications|Influenza-related complications were defined as the occurrence of sinusitis, otitis, bronchitis, and pneumonia as reported on the influenza-related complications CRF.|10 days|The Intent-to-Treat Infected-Non-NAI-Containing SOC (ITTI-Non-NAI) population included randomized subjects who received at least 1 dose of study drug, had confirmed influenza, and who received an SOC that does not contain an NAI at randomization.||participants|||Number
799793|NCT00958568|Secondary|Change From Week 20 to Week 47 Endpoint in the Sheehan Disability Scale (SDS)|The SDS is completed by the participant and is used to assess the effect of the participant's symptoms on their work or school (Item 1), social (Item 2), and family life and home responsibilities (Item 3). Each item is measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. Total scores is the sum of the 3 items and range from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. Least Squares (LS) Mean values were controlled for baseline (Week 20), treatment and country.|Randomization (Week 20), up to Week 47|All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) SDS score measurements. Last observation carried forward (LOCF) principle was used.||units on a scale||Standard Error|Least Squares Mean
799794|NCT00958568|Secondary|Resource Utilization (Number of Psychiatric Visits, Number of Emergency Room or Equivalent Facility Visits for Psychiatric Illness)|Resource utilization is defined as the average number of psychiatric visits and number of emergency room or equivalent facility visits for psychiatric illness.|Randomization (Week 20) to Week 47|All randomized participants who provided information of psychiatric visits and emergency room or equivalent facility visits for psychiatric illness from Week 21 to Week 47.||visits per participant||Standard Deviation|Mean
799795|NCT00958568|Secondary|Resource Utilization - Average Number of Hours Worked for Pay Per Week at Week 47||Week 47|All randomized participants who worked for pay at Week 47.||hours||Standard Deviation|Mean
799796|NCT00958568|Secondary|Mean Change From Week 20 to Week 47 in Clinical Global Impressions - Severity (CGI-S) of Depression Using Mixed-Effects Model Repeated Measures (MMRM) Analysis|CGI-S measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Least Squares (LS) Mean values were controlled for baseline (Week 20), treatment, country, visit, and treatment by visit interaction.|Randomization (Week 20), Week 47|All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) CGI-S measurements.||units on a scale||Standard Error|Least Squares Mean
799797|NCT00958568|Secondary|Mean Change From Week 20 to Week 47 in Montgomery-Asberg Depression Rating Scale (MADRS) Using Last Observation Carried Forward (LOCF) Analysis|The MADRS has a 10-item checklist with items rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Least Squares (LS) Mean values were controlled for baseline (Week 20), treatment and country.|Randomization (Week 20), up to Week 47|All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) MADRS measurements. LOCF principle was used.||units on a scale||Standard Error|Least Squares Mean
799798|NCT00958568|Secondary|Mean Change From Week 20 to Week 47 in Montgomery-Asberg Depression Rating Scale (MADRS) Using Mixed-Effects Model Repeated Measures (MMRM) Analysis|The MADRS has a 10-item checklist with items rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Least Squares (LS) Mean values were controlled for baseline (Week 20), treatment, country, visit, and treatment by visit interaction.|Randomization (Week 20), Week 47|All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) MADRS measurements.||units on a scale||Standard Error|Least Squares Mean
799799|NCT00958568|Secondary|Percentage of Participants Maintaining Remission|Remission is defined as the Montgomery-Asberg Depression Rating Scale (MADRS) score ≤8. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist with items rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Randomization (Week 20) to Week 47|All randomized participants.||percentage of participants|||Number
799800|NCT00958568|Secondary|Percentage of Participants Achieving Remission at Any Point During Stabilization Treatment Phase|Remission is defined as the Montgomery-Asberg Depression Rating Scale (MADRS) score ≤8. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist with items rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Week 8 to Week 20|All participants who entered open-label stabilization treatment phase (SPIII).||percentage of participants|||Number
799801|NCT00958568|Secondary|Percentage of Participants Maintaining Response at Any Point During Stabilization Treatment Phase|A 50% or greater improvement from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) and a Clinical Global Impressions-Severity (CGI-S) of Depression score ≤3 will be considered as response criteria met. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist with items rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). CGI-S measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).|Week 8 to Week 20|All participants who entered open-label stabilization treatment phase (SPIII).||percentage of participants|||Number
799802|NCT00958568|Secondary|Percentage of Participants Responding to Treatment During Open-Label Acute Treatment Phase|A 50% or greater improvement from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) and a Clinical Global Impressions-Severity (CGI-S) of Depression score ≤3 will be considered as response criteria met. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist with items rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). CGI-S measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).|Week 0 to Week 8|All participants who entered open-label acute treatment phase (SPII).||percentage of participants|||Number
799803|NCT00958568|Secondary|Time to Relapse as Measured by Discontinuation Due to Lack of Efficacy/Worsening of Depression/Suicidality|"Lack of Efficacy/Worsening of depression was at the discretion of the investigator and was based on clinical observation. Suicidality is thoughts or actions of self-harm as determined by the investigator. Those who did not relapse were censored at their last observation."|Randomization (Week 20) to Week 47|All randomized participants are included in the time to event analyses. The numbers of participants censored are 197 and 160 for OFC and Flu groups, respectively.||days||Full Range|Median
799855|NCT00959049|Primary|Geometric Mean Titer 30 Days After the Last Study Vaccination||30 days after the last study vaccination|Per-protocol population||Titers||95% Confidence Interval|Geometric Mean
799805|NCT00958568|Secondary|Time to Relapse Based on the Montgomery-Åsberg Depression Rating Scale (MADRS) Score With Concomitant Clinical Global Impressions-Severity (CGI-S) of Depression Score|"Relapse is defined as a 50% increase in the Montgomery-Asberg Depression Rating Scale (MADRS) score from randomization with concomitant Clinical Global Impressions-Severity (CGI-S) of Depression score increase to a score of 4 or more. The MADRS has a 10-item checklist with items rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). CGI-S measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (the most extremely ill). Those who did not relapse were censored at their last observation."|Randomization (Week 20) to Week 47|All randomized participants are included in the time to event analyses. The numbers of participants censored are 190 and 160 for OFC and Flu groups, respectively.||days||Full Range|Median
799806|NCT00958568|Secondary|Percentage of Participants Who Relapse as Measured by Discontinuation Due to Lack of Efficacy/Worsening of Depression/Suicidality|Lack of Efficacy/Worsening of depression was at the discretion of the investigator and was based on clinical observation. Suicidality is thoughts or actions of self-harm as determined by the investigator.|Randomization (Week 20) to Week 47|All randomized participants.||percentage of participants|||Number
799807|NCT00958568|Secondary|Percentage of Participants Who Relapse as Measured by Hospitalization for Depression or Suicidality||Randomization (Week 20) to Week 47|All randomized participants.||percentage of participants|||Number
799808|NCT00958568|Secondary|Percentage of Participants Who Relapse Based on Montgomery-Åsberg Depression Rating Scale (MADRS) Score With Concomitant Clinical Global Impressions-Severity (CGI-S) of Depression Score|Relapse is defined as a 50% increase in the Montgomery-Asberg Depression Rating Scale (MADRS) score from randomization with concomitant Clinical Global Impressions-Severity (CGI-S) of Depression score increase to a score of 4 or more. The MADRS has a 10-item checklist with items rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). CGI-S measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (the most extremely ill).|Randomization (Week 20) to Week 47|All randomized participants.||percentage of participants|||Number
799809|NCT00958568|Secondary|Percentage of Participants Who Relapse by Any Criteria|Relapse is defined as meeting any of the following criteria: 50% increase in Montgomery-Asberg Depression Rating Scale (MADRS) score from randomization with concomitant Clinical Global Impressions-Severity (CGI-S) of Depression score increase to a score of 4 or more; Hospitalization for depression or suicidality; Discontinuation due to lack of efficacy/worsening of depression/suicidality. MADRS is a rating scale for severity of depressive mood symptoms with 10 items rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). CGI-S measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (the most extremely ill). Lack of Efficacy/Worsening of depression was at the discretion of the investigator and based on clinical observation. Suicidality is thoughts or actions of self-harm as determined by the investigator.|Randomization (Week 20) to Week 47|All randomized participants.||percentage of participants|||Number
799810|NCT00958568|Primary|Time to Relapse by Any Criteria|"Relapse defined as meeting any of these criteria: 50% increase in Montgomery-Asberg Depression Rating Scale (MADRS) score from randomization with a Clinical Global Impressions-Severity (CGI-S) of Depression score increase to a score of 4 or more; Hospitalized for depression or suicidality; Discontinued due to lack of efficacy/worsening of depression/suicidality. MADRS is a 10-item rating scale for depressive mood symptoms severity, items rated on 0-6 scale, with total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). CGI-S measures severity of illness at time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (the most extremely ill). Lack of Efficacy/Worsening of depression was at discretion of investigator based on clinical observation. Suicidality is thoughts or actions of self-harm as determined by the investigator. Those who did not relapse were censored at their last observation."|Randomization (Week 20) to Week 47|All randomized participants are included in the time to event analyses. The numbers of participants censored are 186 and 152 for OFC and Flu groups, respectively.||days||Full Range|Median
799811|NCT00958776|Other Pre-specified|Change in Viral Sensitivity to Peramivir, Oseltamivir, and Zanamivir; Fold Change From Initial|Viral sensitivity to peramivir, oseltamivir, and zanamivir was assessed over time during the study, and was presented as fold change from initial sensitivity by influenza virus subtype. Initial assessment of susceptibility may have occurred at a post-baseline visit.|Initial (baseline or post-baseline) and up to 10 days|The Intent-to-Treat Infected (ITTI) population included randomized subjects who received at least 1 dose of study drug, and had confirmed influenza A or B.||fold change||Standard Deviation|Mean
799812|NCT00958776|Other Pre-specified|Initial Viral Sensitivity to Peramivir, Oseltamivir, and Zanamivir; IC50 (nM)|Initial viral sensitivity to peramivir, oseltamivir, and zanamivir was assessed over time during the study, and was presented by influenza virus subtype. Initial assessment of susceptibility may have occurred at a post-baseline visit.|Initial (baseline or post-baseline) and up to 10 days|The Intent-to-Treat Infected (ITTI) population included randomized subjects who received at least 1 dose of study drug, and had confirmed influenza A or B.||nM||Standard Deviation|Mean
799813|NCT00958776|Other Pre-specified|Survival at 14 and 28 Days After Initiation of Study Drug (Kaplan-Meier Estimate)|Survival was calculated as the number of days from initiation of study drug until death or last contact. Estimates and 95% confidence intervals were calculated using the method of Kaplan-Meier and presented by treatment group.|28 days|The Intent-to-Treat Infected-Non-NAI-Containing SOC (ITTI-Non-NAI) population included randomized subjects who received at least 1 dose of study drug, had confirmed influenza, and who received an SOC that does not contain an NAI at randomization.||Percent Survival||95% Confidence Interval|Number
799814|NCT00958776|Other Pre-specified|Number of Subjects Requiring More Than 5 Days of Study Drug|Subjects who had not met the protocol-defined criteria of clinical resolution on Day 5 or who had detectable virus by RT-PCR from a sample collected on Study Day 4 after dosing continued their assigned treatment for a further 5 days.|10 days|The Intent-to-Treat Infected-Non-NAI-Containing SOC (ITTI-Non-NAI) population included randomized subjects who received at least 1 dose of study drug, had confirmed influenza, and who received an SOC that does not contain an NAI at randomization.||participants|||Number
799816|NCT00958776|Other Pre-specified|Time to Hospital Discharge|Time to hospital discharge, defined as the number of days from initiation of study treatment until the subject was discharged from the hospital, was summarized by treatment group using the method of Kaplan-Meier. Subjects who were not discharged from the hospital were censored at their last study visit.|10 days|The Intent-to-Treat Infected-Non-NAI-Containing SOC (ITTI-Non-NAI) population included randomized subjects who received at least 1 dose of study drug, had confirmed influenza, and who received an SOC that does not contain an NAI at randomization.||days||95% Confidence Interval|Median
799817|NCT00958776|Secondary|Duration of All ICU Admissions (Kaplan-Meier Estimate)|Duration of postbaseline ICU admission was defined as the total number of days in the ICU for those subjects who had a post-baseline admission to the ICU. Only days starting after the initial postbaseline admission were included. If a subject's stay in the ICU was ongoing, the duration was censored at the last study visit. Subjects who did not have a postbaseline admission had a duration of 0.|10 days|The Intent-to-Treat Infected-Non-NAI-Containing SOC (ITTI-Non-NAI) population included randomized subjects who received at least 1 dose of study drug, had confirmed influenza, and who received an SOC that does not contain an NAI at randomization.||days||95% Confidence Interval|Median
799818|NCT00958776|Secondary|Number of Subjects With ICU Admission|The number of subjects requiring ICU admission post-randomization was summarized by treatment group.|10 days|The Intent-to-Treat Infected-Non-NAI-Containing SOC (ITTI-Non-NAI) population included randomized subjects who received at least 1 dose of study drug, had confirmed influenza, and who received an SOC that does not contain an NAI at randomization.||participants|||Number
799819|NCT00958776|Secondary|Time to Resumption of Usual Activities|Time to resumption of usual activities was determined from the visual analog scale (scale ranged from 0 to 10 where 0 indicated subject was unable to perform usual activities at all and 10 indicated subject was able to perform all usual activities fully). Time to resumption of usual activities was summarized by treatment group using the method of Kaplan-Meier.|10 days|The Intent-to-Treat Infected-Non-NAI-Containing SOC (ITTI-Non-NAI) population included randomized subjects who received at least 1 dose of study drug, had confirmed influenza, and who received an SOC that does not contain an NAI at randomization.||days||95% Confidence Interval|Median
799820|NCT00958776|Secondary|Time to Resolution of Fever (Kaplan-Meier Estimate)|Time to resolution of fever was measured as the time from initiation of study treatment until resolution of fever, maintained for at least 24 hours; temperature measurements taken less than 4 hours after antipyretic use were treated as missing values.|10 days|The Intent-to-Treat Infected-Non-NAI-Containing SOC (ITTI-Non-NAI) population included randomized subjects who received at least 1 dose of study drug, had confirmed influenza, and who received an SOC that does not contain an NAI at randomization.||hours||95% Confidence Interval|Median
799821|NCT00958776|Secondary|Time to Alleviation of Clinical Symptoms of Influenza|Time to alleviation of clinical symptoms of influenza was measured as the time from the first dose of study drug through the time period in which all 7 symptoms of influenza (cough, sore throat, nasal congestion, myalgia [aches and pains], headache, feverishness, and fatigue) were absent or rated as no greater than mild for at least 24 hours. Time to alleviation of symptoms was estimated using the method of Kaplan-Meier. Subjects who did not have resolution of any individual clinical sign were censored at the time of their last non-missing assessment of that sign.|10 days|The Intent-to-Treat Infected-Non-NAI-Containing SOC (ITTI-Non-NAI) population included randomized subjects who received at least 1 dose of study drug, had confirmed influenza, and who received an SOC that does not contain an NAI at randomization.||hours||95% Confidence Interval|Median
799822|NCT00958776|Secondary|Change (Reduction) in Influenza Virus Titer|The reduction in viral shedding was assessed as the change from baseline in log10 tissue culture infective dose50 (TCID50/mL) and RT-PCR and was summarized for each treatment group and study visit.|Baseline and 24, 48, 108 hours|The Intent-to-Treat Infected-Non-NAI-Containing SOC (ITTI-Non-NAI) population included randomized subjects who received at least 1 dose of study drug, had confirmed influenza, and who received an SOC that does not contain an NAI at randomization.||log10 viral particles/mL||95% Confidence Interval|Median
799823|NCT00958776|Primary|Time to Clinical Resolution (Kaplan-Meier Estimate)|Time to clinical resolution was defined as the time in hours from initiation of study treatment until normalization of at least 4 of the 5 signs within the respective normalization criteria, maintained for at least 24-hours. Time to clinical resolution was summarized by treatment group using the method of Kaplan-Meier. For subjects who did not experience clinical resolution, values were censored at the date of their last non-missing assessment of clinical resolution during the study (whether this assessment occurred as an inpatient or as an outpatient).|10 days|The Intent-to-Treat Infected-Non-NAI-Containing SOC (ITTI-Non-NAI) population included randomized subjects who received at least 1 dose of study drug, had confirmed influenza, and who received an SOC that does not contain a NAI at randomization.||hours||95% Confidence Interval|Median
799824|NCT00958789|Secondary|Knee Society Score (KSS) Change From Pre-op to Post-op Visits|The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, ROM and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as “excellent,” “good,” “fair,” or “poor,” a higher value represents a better outcome.|pre-op, 1, 5 year||||||
799825|NCT00958789|Secondary|Lower Extremity Activity Scale Score Change From Pre-op to Post-op Visits|The LEAS is completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level.|pre-op, 1, 2, 5 years||||||
799826|NCT00958789|Secondary|HSS Patella Score Change From Pre-op to Post-op Visits|The HSS Patella Score incorporates both subjective symptoms and objective data specific to the patellofemoral joint. It consists of one score from 0-100 with a score of 100 indicating no pain, no functional limitations, no tenderness or crepitus and normal quadriceps strength.|pre-op, 1, 2, 5 years||||||
799827|NCT00958789|Secondary|Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Pre-op to Post-op Visits|KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.|pre-op, 1, 2, 5 years||||||
799828|NCT00958789|Secondary|Revision Rates||5 years||||||
799829|NCT00958789|Secondary|Radiographic Stability|Parameters for radiographic failures will follow the guidelines that have been set by the Knee Society. The scoring system for each of the three components is determined by measuring the width of the radiolucent lines for each of the zones in millimeters for each of the three components. The total widths are added for each zone for each of the three prostheses. The total produces a numerical score for each component. Failure is defined as a score of 10 or greater, regardless of symptoms. A migrating or shifting prosthesis, with or without the disappearance of radiolucent lines, should be considered as a possible or impending failure regardless of the score. Radiolucency in at least 50% of a zone and measuring at least 1 mm in width is defined as radiolucency present. Subsidence is defined as settling of the prosthetic component in bone, and is related to the distance between fixed bony landmarks on the tibia and the prosthesis.|1, 2, 5 years||||||
799830|NCT00958789|Secondary|SF-36 Health Survey Change From Pre-op to Post-op Visits|The SF-36 Health Survey is a 36-item patient completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.|pre-op, 1, 2, 5 years||||||
799831|NCT00958789|Secondary|The Effect of Joint Line Restoration on Post-op Stability, Anterior Knee Pain & Functional Performance.||2 years, 5 years||||||
799832|NCT00958789|Primary|Knee Society Score (KSS) Change From Preoperative Time Point to 2 Years|"KSS Pain score, KSS Function score, Total Combined KSS
The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, ROM and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as “excellent,” “good,” “fair,” or “poor,” a higher value represents a better outcome.
Additionally, the KSS Pain subscore and KSS Function subscore are added together to obtain a total combined score (minimum score 0, maximum score 200)."|pre-op, 2 years|KSS Function Score at 2 years - One case had a calculable score for Function and not for Pain/Motion. Therefore, the case was not included in the Combined KSS Score and Participant Flow completed total of 130.||units on a scale|knees|Standard Deviation|Mean
799833|NCT00958828|Primary|Overall Lens Satisfaction|Overall Lens Satisfaction, as interpreted by the subject and reported by the subject on a questionnaire as a single, retrospective evaluation of 1-week’s wear time. Overall lens satisfaction was measured on a 10-point scale, with 1 being poor and 10 being excellent.|After 1 week of wear|Per protocol||Units on a scale||Standard Deviation|Mean
799834|NCT00958841|Secondary|Nelson's Syndrome: Number of Patients Attaining Normalization or a More Than 50% Reduction in Primary Biochemical Tumor Marker|Six patients with Nelson’s syndrome met the responder’s criteria of attaining normalization or a reduction of more than 50% in primary tumor marker at Month 6.|Baseline, month 6|The efficacy analyzable set included all enrolled patients who received at least one dose of pasireotide LAR and had indication-specific baseline primary biochemical tumor marker levels >ULN. Responder analysis are reported only for indications with minimum of 6 patients. Patients with missing Month 6 assessment were considered as non-responders.||Participants|||Number
799835|NCT00958841|Secondary|PiNETs: Number of Patients Attaining Normalization or a More Than 50% Reduction in Primary Biochemical Tumor Marker|Specific primary biochemical tumor markers were used to assess the efficacy of pasireotide in PNETs. A Month 6 responder was defined as the patients who either attained normalization or greater than 50% reduction from baseline in the level of the primary biochemical tumor marker at Month 6.|Baseline, month 6|The efficacy analyzable set included all enrolled patients who received at least one dose of pasireotide LAR and had indication-specific baseline primary biochemical tumor marker levels >ULN. Responder analysis are reported only for indications with minimum of 6 patients. Patients with missing Month 6 assessment were considered as non-responders.||Participants|||Number
799836|NCT00958841|Secondary|PNETs: Number of Patients Attaining Normalization or a More Than 50% Reduction in Primary Biochemical Tumor Marker|Specific primary biochemical tumor markers were used to assess the efficacy of pasireotide in PNETs. A Month 6 responder was defined as the patients who either attained normalization or greater than 50% reduction from baseline in the level of the primary biochemical tumor marker at Month 6. One gastrinoma patient had a missing primary tumor marker value at Month 6, but had a Month 5 assessment done on Day 141, which fell within the allowed window period for Month 6.|Baseline, month 6|The efficacy analyzable set included all enrolled patients who received at least one dose of pasireotide LAR and had indication-specific baseline primary biochemical tumor marker levels >ULN. Responder analysis are reported only for indications with minimum of 6 patients. Patients with missing Month 6 assessment were considered as non-responders.||Participants|||Number
799837|NCT00958841|Secondary|Percentage of Responders With Probability of Success at Month 6 - Individual NETs|Percentage of responders for each of the 10 NET indications considered in the study. Responder analyses were performed for an indication only if there were at least 6 patients in the efficacy analyzable set. For all other individual indications, the numbers of patients in the efficacy analyzable sets were less than 6 and therefore no responder analyses were carried out for these indications. The probability of success was a chance that the true responder rate was greater than 15%) for the indications gastrinoma, prolactinoma, and Nelson’s syndrome.|6 months|The efficacy analyzable set included all enrolled patients who received at least one dose of pasireotide LAR and had indication-specific baseline primary biochemical tumor marker levels >ULN.||Percentage of participants|||Number
799838|NCT00958841|Secondary|Percentage of Responders at Month 6 - Individual NETs|Percentage of responders for each of the 10 NET indications considered in the study. Responder analyses were performed for an indication only if there were at least 6 patients in the efficacy analyzable set. For all other individual indications, the numbers of patients in the efficacy analyzable sets were less than 6 and therefore no responder analyses were carried out for these indications.|6 months|The efficacy analyzable set included all enrolled patients who received at least one dose of pasireotide LAR and had indication-specific baseline primary biochemical tumor marker levels >ULN.||percentage of participants|||Number
799856|NCT00959049|Secondary|Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C||7 days after vaccination|Safety population||Participants|||Number
799857|NCT00959049|Secondary|Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B||7 days after each vaccination|Safety population; Afluria cohort B receiving 2 doses N=68, Fluzone cohort B receiving 2 doses N=78||Participants|||Number
820714|NCT01147497|Secondary|Ease of Insertion and Presence of Pain in Nulliparous Women Versus Nulligravid Women||assessed immediately following insertion||||||
799839|NCT00958841|Primary|Percentage of Responders at Month 6 - Pooled Pancreatic NETs (PNETs)|The primary efficacy endpoint was defined as the percentage of responders at Month 6 among pooled PNET patients (insulinoma, gastrinoma, VIPoma, and glucagonoma). A responder was defined as a patient who either attained normalization or had a greater than 50% reduction from baseline of the level of the primary biochemical tumor marker at Month 6 (M6). Four insulinoma pts were excluded from analysis because of unavailability of normal ranges for the associated primary biochemical tumor marker (insulin-to-glucose ratio). One patient with VIPoma with a normal baseline was also excluded. As a result, only 20 out of 25 patients with PNET were included in the assessment of the primary endpoint, which was less than the planned sample size of 34. Therefore, the primary objective could not be assessed with sufficient power. Patients with missing Month 6 assessment were considered as non-responders. Responder analyses are reported only for indications with minimum of 6 patients.|6 months|The efficacy analyzable set included all enrolled patients who received at least one dose of pasireotide LAR and had indication-specific baseline primary biochemical tumor marker levels >ULN. Patients with baseline primary biochemical tumor marker levels either missing at baseline or missing ULN or baseline value ≤ ULN were excluded.||percentage of participants|||Number
799840|NCT00958880|Secondary|Social Phobic Disorders Severity and Change Form|Social Phobic Disorders Severity and Change (SPDSC) Form is a version of the Clinical Global Improvement-Severity scale adapted specifically for clinician ratings of social anxiety disorder symptom severity. The scale ranges from 0 to 5, with higher scores indicating more social anxiety symptoms severity (i.e., worse outcomes). We examined the change in SPDSC scores from baseline to a 1 month follow-up.|CGI change scores from baseline to 1 month follow-up|||units on a scale||Standard Deviation|Mean
799841|NCT00958880|Primary|The Liebowitz Social Anxiety Scale (LSAS)|The Liebowitz Social Anxiety Scale (LSAS) is a self-report measure of social anxiety symptom severity. Scores range from 0 to 144, with higher scores indicating more social anxiety symptoms severity (i.e., a worse outcome).|LSAS means at 1 month follow-up|||units on a scale||Standard Deviation|Mean
799842|NCT00958893|Primary|To Further Evaluate Adverse Events of a 25 mg Dose of Proellex® Administered to Women Once Daily for Three 4 Month Cycles Separated by Off-drug Intervals.||three 4 month cycles separated by off-drug intervals||||||
799843|NCT00958919|Secondary|Change in Level of B-endorphin Immunoreactivity During Saline Intervention|Change in serum levels of beta-endorphin immunoreactivity measured in pmol/L in subjects receiving Saline|Baseline and at the end of Resistance Load Breathing during either Period 1 (Day 3 or 4) or Period 2 (Day 5, 6 or 7) depending on randomization|Total number of subjects completing period with saline intervention.||pmol/L||Standard Deviation|Mean
799844|NCT00958919|Secondary|Change in Level of B-endorphin Immunoreactivity During Naloxone Intervention|Change in serum levels of beta-endorphin immunoreactivity measured in pmol/L in subjects receiving Naloxone|Baseline and at the end of Resistance Load Breathing during either Period 1 (Day 3 or 4) or Period 2 (Day 5, 6 or 7) depending on randomization|Total number of subjects completing period with Naloxone intervention.||pmol/L||Standard Deviation|Mean
799845|NCT00958919|Secondary|Endurance Time|Length of time that subjects were able to continue Resistive Load Breathing|Period 1 (Day 3 or 4) and Period 2 (Day 5, 6 or 7)|Total number of subjects completing both periods of the study.||minutes||Standard Deviation|Mean
799846|NCT00958919|Primary|Unpleasantness of Breathlessness|"The average of all ratings for the unpleasantness of breathlessness at equivalent times for each subject during Resistive Load Breathing (RLB). For example, if 1 subject provided 6 ratings during 6 minutes of RLB with naloxone and 10 ratings during 10 minutes of RLB with normal saline, then ratings for intensity through 6 minutes were used for analysis for that patient. This approach was used for all subjects to yield a total of 154 ratings for naloxone and for normal saline.
Subject rating of intensity of unpleasantness was obtained during RLB on a 100 mm Visual Analog Scale anchored at the bottom by No Unpleasantness and at the top by Greatest Unpleasantness."|At 1 minute intervals during Resistive Load Breathing at Period 1 (Day 3 or 4) and Period 2 (Day 5, 6 or 7)|Total number of subjects completing both periods of the study.||units on a scale||Standard Deviation|Mean
799847|NCT00958919|Primary|Intensity of Breathlessness|"The average of all ratings for the intensity of breathlessness at equivalent times for each subject during Resistive Load Breathing (RLB). For example, if 1 subject provided 6 ratings during 6 minutes of RLB with naloxone and 10 ratings during 10 minutes of RLB with normal saline, then ratings for intensity through 6 minutes were used for analysis for that patient. This approach was used for all subjects to yield a total of 154 ratings for naloxone and for normal saline.
Subject rating of intensity of breathlessness was obtained at 1 minute intervals during RLB on a 100 mm Visual Analog Scale anchored at the bottom by No Intensity and at the top by Greatest Intensity."|At 1 minute intervals during Resistive Load Breathing at Period 1 (Day 3 or 4) and Period 2 (Day 5, 6 or 7)|Total number of subjects completing both periods of the study.||units on a scale||Standard Deviation|Mean
799848|NCT00959049|Secondary|Duration of Local and Systemic Solicited Symptoms, Cohort C||7 days after vaccination|Safety population||Days||Standard Deviation|Mean
799849|NCT00959049|Secondary|Duration of Local and Systemic Solicited Symptoms, Cohort B||7 days after each vaccination|Safety population||Days||Standard Deviation|Mean
799850|NCT00959049|Secondary|Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)||7 days after each vaccination|Safety population||Days||Standard Deviation|Mean
799851|NCT00959049|Secondary|Serious Adverse Events (SAEs)||6 months after last study vaccination|Safety Population||Participants|||Number
799852|NCT00959049|Secondary|New Onset of Chronic Illnesses (NOCIs)|New onset of chronic illness after any vaccine dose. A new onset of chronic illness was defined as the diagnosis of a new medical condition which was chronic in nature, including those potentially controllable by medication (e.g., diabetes, asthma).|6 months after last study vaccination|Safety population||Participants|||Number
799853|NCT00959049|Secondary|Frequency and Intensity of Unsolicited Adverse Events (UAEs)|UAE stands for Unsolicited Adverse Events|30 days after each vaccination|Safety population||Participants|||Number
799854|NCT00959049|Primary|Percentage of Participants With Seroconversion 30 Days After the Last Study Vaccination|Seroconversion rate was defined as the proportion of participants with either a titer of less than 1:10 before vaccination achieving a HI antibody titer of 1:40 or more after vaccination, or a HI titer of 1:10 or more before vaccination achieving a four-fold or greater increase in HI titer after vaccination.|30 days after the last study vaccination|Per-Protocol Population||Percentage of participants||95% Confidence Interval|Number
799859|NCT00959192|Other Pre-specified|The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 40, 52, 78 and 104.|The MMSE is a brief, structured examination of cognitive function. It has a total score of 30 points (0-30), and any score equal to or lower than 26 points indicates cognitive impairment.|Baseline up to 24 months|Efficacy analyses were performed on the modified intent-to-treat (mITT) population. The mITT population included all of the randomly assigned participants who took at least one dose of study medication, and had the baseline and at least one post baseline evaluation of the key efficacy variable (ADAS-Cog).||Units on a scale||Standard Deviation|Mean
799860|NCT00959192|Other Pre-specified|The Mean Changes in Neuropsychological Test Battery (NTB) Score From Baseline at Week 12, 26, 52 and 78.|The NTB is a composite of nine widely used neuropsychological tests that assess immediate and delayed recall of verbal and visual information, attention, verbal fluency and executive function. The cognitive tests included in the NTB are the Wechsler Memory Scale (WMS) Visual-Paired Associates (immediate and delayed), WMS-Verbal Paired Associates (immediate and delayed), Rey Auditory Verbal Learning Test (immediate and delayed), WMS-Digit Span, Controlled Word Association Test, and Category Fluency Test. The NTB z-score is used for analysis. The z-score for each component is calculated through the following formula: z = (y_visit – y_base)/SD_base, where y_visit is a value at a particular time point and y_base is the average test score, and SD_base is the SD based on all participants’ observed baseline scores in the study.|Baseline up to 24 months|Efficacy analyses were performed on the modified intent-to-treat (mITT) population. The mITT population included all of the randomly assigned participants who took at least one dose of study medication, and had the baseline and at least one post baseline evaluation of the key efficacy variable (ADAS-Cog).||Z-score||Standard Deviation|Mean
799861|NCT00959192|Other Pre-specified|The Mean Changes in Disability Assessment for Dementia (DAD) Score From Baseline at Week 12, 26, 52,78 and 104.|"The DAD is administered through an interview with the caregiver and measures instrumental and basic activities of daily living.
A total score is obtained by adding the rating for each question and converting this total score out of 100. Higher scores represent less disability in ADL while lower scores indicate more dysfunction."|Baseline up to 24 months|Efficacy analyses were performed on the modified intent-to-treat (mITT) population. The mITT population included all of the randomly assigned participants who took at least one dose of study medication, and had the baseline and at least one post baseline evaluation of the key efficacy variable (ADAS-Cog).||Units on a scale||Standard Deviation|Mean
799862|NCT00959192|Other Pre-specified|The Mean Changes in Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-Cog) Score From Baseline at Week 12, 26, 52, 78 and 104.|The ADAS-Cog is a 12-item,objective measure of cognitive function, consisting of 1) Word Recall, 2) Naming Objects and Fingers, 3) Following Commands, 4) Constructional Praxis, 5) Ideational Praxis, 6) Orientation, 7) Word Recognition, 8) Recall of Test Instructions, 9) Spoken Language Ability, 10) Word-Finding Difficulty, 11) Comprehension of Spoken Language and 12) Concentration/Distractibility. For this study, the ADAS-Cog total score is derived by summing the individual scores from items 1 to 11. Total score ranges from 0 to 70 points, with higher scores indicating a greater degree of impairment.|Baseline up to 24 months|Efficacy analyses were performed on the modified intent-to-treat (mITT) population. The mITT population included all of the randomly assigned participants who took at least one dose of study medication, and had the baseline and at least one post baseline evaluation of the key efficacy variable (ADAS-Cog).||Units on a scale||Standard Deviation|Mean
799863|NCT00959192|Secondary|Anti-a-beta IgM Titer at Specified Visits|Geotmetric mean of anti-a-beta IgM titer from pre-study through Week 104|Baseline up to 24 months|The population for immunogenicity analysis includes all of the randomly assigned participants who took at least one dose of study medication, having the baseline and at least one post baseline immunogenicity evaluation.||Units/mL||95% Confidence Interval|Geometric Mean
799864|NCT00959192|Secondary|Anti-a-beta IgG Titer at Specified Visits|Geometric mean of anti-a-beta IgG titer from pre-study through Week 104|Baseline up to 24 months|The population for immunogenicity analysis includes all of the randomly assigned participants who took at least one dose of study medication, having the baseline and at least one post baseline immunogenicity evaluation.||Units/mL||95% Confidence Interval|Geometric Mean
799865|NCT00959192|Primary|Number of Participants With Abnormalities in Neurological Examination|Number of participants with abnormalities in neurological examinations as determined by the investigators. Neurological examinations included Mental Status, Speech, Cranial Nerves (including pupil equality and reactivity), Visual field, Sensory, Motor, Coordination, Gait, Primitive reflexes, Tendon reflexes and Romberg.|Baseline up to 24 months|The safety analysis population includes all of the randomly assigned participants who took at least one dose of study medication.||Participants|||Number
799866|NCT00959192|Primary|Number of Participants With Brain Abnormalities in Magnetic Resonance Imaging (MRI) Data|Number of participants with brain abnormalities in MRI data that are either consistent or not consistent with AD, as determined by radiologists.|Baseline up to 24 months|The safety analysis population includes all of the randomly assigned participants who took at least one dose of study medication.||Participants|||Number
799867|NCT00959192|Primary|Incidence of Treatment-emergent Adverse Events (AEs) by Severity|Number of participants who experienced mild, moderate, or severe AEs (mild = does not interfere with subject's usual function; moderate = interferes to some extent with subject's usual function; severe = interferes significantly with subject's usual function)|Baseline up to 24 months|The safety analysis population includes all of the randomly assigned participants who took at least one dose of study medication.||Participants|||Number
799868|NCT00959374|Secondary|Cosmesis|Photographs of scars were obtained at 12 week visit and reviewed by a independent blinded plastic surgeon. The blinded assessor scored four elements of scar appearance on a scale of 1 to 5 each, including color match, width, borders and edges, and contour and distortion. On this scale, 1 = worst, 2= poor, 3= average, 4=good and 5=excellent. For the purpose of analysis, all scores for a patient were summed into a single composite score (4-20).|12 weeks|Subjects who did not return for the 12 week follow-up visit were excluded from the analysis.||units on a scale||Standard Deviation|Mean
799869|NCT00959374|Primary|Total Dermal Closure Time|In calculating the total dermal closure time, only the intradermal closure time is used for those subjects that did not have the deep dermal layer closed.|At time of surgery|Includes only those subjects where a deep dermal layer was closed.||Minutes||Standard Deviation|Mean
799870|NCT00951171|Secondary|Positive Pregnancy Test||14 days||||||
799871|NCT00951171|Secondary|Live Birth||9 months||||||
799877|NCT00959699|Secondary|Percentage of Participants With HCV Virologic Breakthrough or Incomplete Virologic Response/Rebound|Virologic breakthrough is defined as achieving undetectable HCV-RNA and subsequently having an HCV-RNA level of >1000 IU/mL. Incomplete Virologic Response/Rebound is defined as having a one log10 increase in HCV-RNA from the participant's nadir, with an HCV-RNA >1000 IU/mL. HCV-RNA was detected by a nucleic acid amplification test and the lower limit of detection for this assay is 9.3 IU/mL.|Up to Week 72|All randomized participants receiving at least one dose of any study medication (Full Analysis Set); this includes 3 participants who did not enter the Follow-Up Period.||percentage of participants|||Number
799878|NCT00959699|Secondary|Change From Baseline in log10 HCV-RNA at Treatment Week 4 (TW4)|This is a measure of the change in the amount of HCV-RNA in the plasma at the end of 4 weeks of treatment. HCV-RNA was detected by a nucleic acid amplification test and the lower limit of detection for this assay is 9.3 IU/mL.|Baseline and Week 4|All randomized participants receiving at least one dose of any study medication (Full Analysis Set); this includes 3 participants who did not enter the Follow-Up Period.||participants|||Number
799879|NCT00959699|Secondary|Percentage of Participants With Undetectable HCV-RNA at Follow-up Week 12 (FW12)|The virologic response at FW12 was considered SVR12 with an additional rule for handling missing data: participants with missing HCV-RNA assessment at FW12 but having non-missing, undetectable HCV-RNA assessments at both FW4 and FW24, were assumed to be responders for SVR12. HCV-RNA was detected by a nucleic acid amplification test and the lower limit of detection for this assay is 9.3 IU/mL.|Up to Week 60|All randomized participants receiving at least one dose of any study medication (Full Analysis Set); this includes 3 participants who did not enter the Follow-Up Period.||percentage of participants|||Number
799880|NCT00959699|Secondary|Percentage of Participants With Early Virologic Response (EVR) Who Achieved SVR24|EVR was defined as undetectable HCV-RNA at Treatment Week (TW) 2, 4, 8, or 12. HCV-RNA was detected by a nucleic acid amplification test and the lower limit of detection for this assay is 9.3 IU/mL.|Up to Week 12|All randomized participants receiving at least one dose of any study medication (Full Analysis Set); this includes 3 participants who did not enter the Follow-Up Period. No participants had undetectable HCV-RNA at Week 2; the “n” value in the table below represents the number of participants with EVR at that time point.||percentage of participants|||Number
799881|NCT00959699|Secondary|Percentage of Participants Achieving SVR24 Among Randomized Participants Who Received At Least One Dose of Boceprevir (Experimental) or Placebo (Control)|SVR24 is defined as undetectable plasma HCV-RNA 24 weeks after the end of all study treatment. If there was no value in the FW24 visit window, the closest value available chronologically after this window was used; if a value was still missing after that, the value from FW12 was used. HCV-RNA is detected by a nucleic acid amplification test and the lower limit of detection for this assay is 9.3 IU/mL.|Up to Week 72|All randomized participants receiving one dose of boceprevir (PegIFN-2b + RBV + Boceprevir group) or placebo to boceprevir (PegIFN-2b + RBV group), defined as the Modified Intent-to-Treat Population; this includes 2 participants who did not enter the Follow-up Period.||percentage of participants|||Number
799882|NCT00959699|Primary|Percentage of Participants Achieving Sustained Viral Response (SVR) at Follow-up Week 24 (FW24) Among Randomized Participants Who Received At Least One Dose of Trial Medication|SVR24 is defined as undetectable plasma hepatitis C virus ribonucleic acid (HCV-RNA) at 24 weeks after the end of all study treatment. If there was no value in the FW24 visit window, the closest value available chronologically after this window was used; if a value was still missing after that, the value from Follow-up Week 12 (FW12) was used. HCV-RNA is detected by a nucleic acid amplification test and the lower limit of detection for this assay is 9.3 IU/mL.|Up to Week 72|All randomized participants receiving at least one dose of any study medication (Full Analysis Set); this includes 3 participants who did not enter the Follow-Up Period.||percentage of participants|||Number
799883|NCT00959751|Post-Hoc|Sustained Complete Headache Relief (Efficacy Evaluable Analysis Set)|Exploratory Post-hoc Analysis: Sustained complete headache relief is defined as a reduction in headache severity from moderate or severe to absent over all indicated time points.|2 - 48 hours|Efficacy Evaluable Analysis Set includes all subjects in the Full Analysis Set with an observed or imputed HSS (using rules predefined in the Statistical Analysis Plan [SAP]) at both the 2-hour time point and the 4-hour time point when using the modified LOCF approach||Participants|||Number
799884|NCT00959751|Secondary|Overall Evaluation of Study Medication at 24 Hours Post Administration (Full Analysis Set)|Overall evaluation of the study drug was measured with a 4-point scale at 24 hours and used the following categories: 1 = Poor; 2 = Moderate; 3 = Good; and,4 = Excellent|24 hours|Full Analysis Set includes all subjects in the Safety Population who had at least one post-dose observation for headache severity recorded in his or her diary.||Participants|||Number
799885|NCT00959751|Secondary|Time (Hours) to First Use of Rescue Medication (Full Analysis Set)|Subjects who do not require rescue medication are censored at the time of their last diary assessment completed up to 24 hours following study drug administration.|24 Hours|Full Analysis Set includes all subjects in the Safety Population who had at least one post-dose observation for headache severity recorded in his or her diary.||Participants who required rescue||95% Confidence Interval|Median
799886|NCT00959751|Primary|Headache Recurrence (Modified LOCF - Efficacy Evaluable Analysis Set)|Headache recurrence is defined as any subject that experiences headache relief at the given time point (i.e., 2 hours or 4 hours), who did not use rescue medication and who experienced a worsening of their headache to moderate or severe within 24 hours following study drug administration. The denominator is the number of subjects who experienced headache relief at 2 hours/4 hours.|4 hours|30 and 42 placebo and NXN-188 subjects, respectivley, experienced headache relief at 2 hours. 41 and 55 placebo and NXN-188 subjects, respectively, experienced headache relief at 4 hours.||Participants|||Number
799887|NCT00959751|Secondary|Complete Headache Relief (Efficacy Evaluable Analysis Set)||72 hours|||Participants|||Number
799888|NCT00959751|Secondary|Headache Relief Based on a 1-Point Reduction From Baseline (Modified LOCF - Efficacy Evaluable Analysis Set)|The Headache Severity Score (HSS) assessment was recorded in the diary by the subject and used the following categories: 0 = no pain; 1 = mild pain; 2 = moderate pain; and, 3 = severe pain|72 hours|||Participants|||Number
799889|NCT00959751|Secondary|Headache Relief Based on a 2-Point Reduction From Baseline (Modified LOCF - Efficacy Evaluable Analysis Set)|The Headache Severity Score (HSS) assessment was recorded in the diary by the subject and used the following categories: 0 = no pain; 1 = mild pain; 2 = moderate pain; and, 3 = severe pain|72 hours|||Participants|||Number
799892|NCT00959764|Secondary|Change in Plasma C-terminal Telopeptide of Collagen 1 (CTx-1)|Change from baseline in plasma CTx-1 at 24 and 48 weeks. CTx-1 is an accepted plasma biomarker as evidence of an effect on bone resorption and the effect of oral calcitonin was compared to that of intranasal calcitonin, both vs placebo.|24 weeks|Modified Intent-to-Treat Population||percentage change from baseline||Standard Deviation|Least Squares Mean
799893|NCT00959764|Primary|Percent Change From Baseline in Bone Mineral Density (BMD) of Axial Lumbar Spine|Bone Mineral Density is measured by Dual-Energy X-ray Absorptiometry (DXA) body scans. Two scans were taken for each timepoint(baseline, week 24 and week 48) and the mean of the two values was entered. The primary outcome timepoint was 48 weeks, but if a patient did not complete the full study, then the 24 week BMD value was used as Last Observation Carried Forward. The percentage change from the baseline value, set as 0%, was recorded as the primary outcome measure.|48 weeks|Patients who were randomized, received treatment, and had at least one post-baseline BMD value measured at least 154 days after randomization.||Percentage increase from baseline||Standard Deviation|Least Squares Mean
799894|NCT00961116|Primary|The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞)|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.|Pharmacokinetic analyses are based on 49 out of 54 enrolled subjects who completed this study.||ng-hr/mL||Standard Deviation|Mean
799895|NCT00961116|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.|Pharmacokinetic analyses are based on 49 out of 54 enrolled subjects who completed this study.||ng-hr/mL||Standard Deviation|Mean
799896|NCT00961116|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that the drug reaches in the plasma.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.|Pharmacokinetic analyses are based on 49 out of 54 enrolled subjects who completed this study.||ng/mL||Standard Deviation|Mean
799897|NCT00961181|Secondary|Device Success|"Device success defined as exact deployment of the device as documented by two different projections assessed by quantitative coronary angiography (QCA).
Offline quantitative coronary angiography (QCA) analysis was performed by an independent core laboratory (Ulrich Dietz, MD, Deutsche Klinik für Diagnostik, Wiesbaden, Germany)."|directly after intervention (after finalized treatment)|||participants|||Number
799898|NCT00961181|Secondary|Technical Success|"Technical success is defined as successful vascular access, completion of the endovascular procedure and immediate morphological success with < 30% residual diameter stenosis assessed by quantitative coronary angiography (QCA).
Diameter stenosis is defined as the difference between reference vessel diameter and minimal lumen diameter divided by reference vessel diameter x100%.
Offline quantitative coronary angiography (QCA) analysis was performed by an independent core laboratory (Ulrich Dietz, MD, Deutsche Klinik für Diagnostik, Wiesbaden, Germany)."|directly after intervention (after finalized treatment)|||participants|||Number
799899|NCT00961181|Secondary|Binary In-segment Restenosis|"In-segment is defined as from proximal shoulder to distal shoulder of the dilated Pantera Lux balloon plus 5 mm proximal and 5 mm distal.
Binary restenosis was defined as a ≥ 50% diameter stenosis at follow-up as evaluated by offline quantitative coronary angiography (QCA).
Diameter stenosis is defined as the difference between reference vessel diameter and minimal lumen diameter divided by reference vessel diameter x100%.
Offline quantitative coronary angiography (QCA) analysis was performed by an independent core laboratory (Ulrich Dietz, MD, Deutsche Klinik für Diagnostik, Wiesbaden, Germany)."|6 months|2 patients died, 2 patients withdrew consent, 6 patients refused repeat angiography at 6 months follow up, 8 patients could not be analysed by QCA||participants|||Number
799900|NCT00961181|Secondary|Binary In-stent Restenosis|"In-sent is defined as from proximal shoulder to distal shoulder of the dilated Pantera Lux balloon.
Binary restenosis was defined as a ≥ 50% diameter stenosis at follow-up as evaluated by offline quantitative coronary angiography (QCA).
Diameter stenosis is defined as the difference between reference vessel diameter and minimal lumen diameter divided by reference vessel diameter x100%.
Offline quantitative coronary angiography (QCA) analysis was performed by an independent core laboratory (Ulrich Dietz, MD, Deutsche Klinik für Diagnostik, Wiesbaden, Germany)."|6 months|2 patients died, 2 patients withdrew consent, 6 patients refused repeat angiography at 6 months follow up, 8 patients could not be analysed by QCA||participants|||Number
799901|NCT00961181|Secondary|In-segment Diameter Stenosis (%DS)|"In-segment is defined as from proximal shoulder to distal shoulder of the dilated Pantera Lux balloon plus 5 mm proximal and 5 mm distal.
Diameter stenosis is defined as the difference between reference vessel diameter and minimal lumen diameter divided by reference vessel diameter x100%.
Offline quantitative coronary angiography (QCA) analysis was performed by an independent core laboratory (Ulrich Dietz, MD, Deutsche Klinik für Diagnostik, Wiesbaden, Germany)."|6 months|2 patients died, 2 patients withdrew consent, 6 patients refused repeat angiography at 6 months follow up, 8 patients could not be analysed by QCA||percentage of re-narrowing||Standard Deviation|Mean
799902|NCT00961181|Secondary|In-stent Diameter Stenosis (%DS)|"In-stent is defined as from proximal shoulder to distal shoulder of the dilated Pantera Lux balloon.
Diameter stenosis is defined as the difference between reference vessel diameter and minimal lumen diameter divided by reference vessel diameter x100%.
Offline quantitative coronary angiography (QCA) analysis was performed by an independent core laboratory (Ulrich Dietz, MD, Deutsche Klinik für Diagnostik, Wiesbaden, Germany)."|6 months|2 patients died, 2 patients withdrew consent, 6 patients refused repeat angiography at 6 months follow up, 8 patients could not be analysed by QCA||percentage of re-narrowing||Standard Deviation|Mean
799903|NCT00961181|Secondary|Cumulative MACE Rate (Composite of Cardiac Death, Non-fatal MI, Clinically Driven TLR, Clinically Driven TVR)|All safety endpoint and serious adverse events were adjudicated by an independent clinical events committee.|12 months|2 patients died, 2 patients withdrew consent, 1 patient lost to follow up||participants|||Number
799904|NCT00961181|Secondary|Cumulative Major Adverse Cardiac Events Rate (Composite of Cardiac Death, Non-fatal Myocardial Infarction, Clinically Driven Target Lesion Revascularization, Clinically Driven Target Vessel Revascularization)|"All safety endpoint and serious adverse events were adjudicated by an independent clinical events committee.
Major Adverse Cardiac Events = MACE Myocardial Infarction = MI Target Lesion Revascularization = TLR Target Vessel Revascularization = TVR"|6 months|2 patients died, 2 patients withdrew consent||participants|||Number
799905|NCT00961181|Secondary|In-segment Late Lumen Loss|"In-segment is defined as from proximal shoulder to distal shoulder of the dilated Pantera Lux balloon plus 5 mm proximal and 5 mm distal.
Late lumen loss is defined as the difference between minimal luminal diameter after procedure and at 6 months, as evaluated by offline quantitative coronary angiography (QCA).
Offline quantitative coronary angiography (QCA) analysis was performed by an independent core laboratory (Ulrich Dietz, MD, Deutsche Klinik für Diagnostik, Wiesbaden, Germany)."|6 months|2 patients died, 2 patients withdrew consent, 6 patients refused repeat angiography at 6 months follow up, 8 patients could not be analysed by QCA||mm||Standard Deviation|Mean
799906|NCT00961181|Primary|In-stent Late Lumen Loss|"In-stent is defined as from proximal shoulder to distal shoulder of the dilated Pantera Lux balloon.
Late lumen loss is defined as the difference between minimal luminal diameter after procedure and at 6 months, as evaluated by offline quantitative coronary angiography (QCA).
Offline quantitative coronary angiography (QCA) analysis was performed by an independent core laboratory (Ulrich Dietz, MD, Deutsche Klinik für Diagnostik, Wiesbaden, Germany)."|6 months|2 patients died, 2 patients withdrew consent, 6 patients refused repeat angiography at 6 months follow up, 8 patients could not be analysed by QCA||mm||Standard Deviation|Mean
799907|NCT00961220|Secondary|Changes in AGT Inactivation in Non-responding Patients|Changes in AGT levels will be determined by biochemical activity assay from first course to seventh course of treatment.|After seventh course at 14 weeks|Attempts to stain AGT and caspase 3 were unsuccessful and there were no remaining tissues for other outcomes.|||||
799908|NCT00961220|Secondary|Changes in AGT Inactivation in Non-responding Patients|Changes in AGT levels will be determined by biochemical activity assay from first course to seventh course of treatment.|After first course at 2 weeks|Attempts to stain AGT and caspase 3 were unsuccessful and there were no remaining tissues for other outcomes.|||||
799909|NCT00961220|Secondary|Changes in DNA Damage- Cytotoxicity|Immunohistochemistry will be used to assess expression of these proteins in keratinocytes, epidermal lymphocytes, and dermal lymphocytes, to determine the effects of BCNU cytotoxicity in each subpopulation of cells|48 hours after the first infusion|Attempts to stain AGT and caspase 3 were unsuccessful and there were no remaining tissues for other outcomes.|||||
799910|NCT00961220|Secondary|Changes in DNA Damage- Cytotoxicity|Immunohistochemistry will be used to assess expression of these proteins in keratinocytes, epidermal lymphocytes, and dermal lymphocytes, to determine the effects of BCNU cytotoxicity in each subpopulation of cells|24 hours after the first infusion|Attempts to stain AGT and caspase 3 were unsuccessful and there were no remaining tissues for other outcomes.|||||
799911|NCT00961220|Secondary|Changes in the Cell Cycle/Proliferation|Comparing skin biopsy specimens of BCNU-protected CTCL lesional specimens vs BCNU-treated lesional specimens at 48 hours, using immunohistochemical staining for Ki-67, PCNA, bcl-2, and caspase-3, as well as y2HAX and TUNEL assays. The proliferation rate will be calculated from these results.|at 48 hours after the first infusion|Attempts to stain AGT and caspase 3 were unsuccessful and there were no remaining tissues for other outcomes.|||||
799912|NCT00961220|Secondary|Changes in the Cell Cycle/Proliferation|Comparing skin biopsy specimens of BCNU-protected CTCL lesional specimens vs BCNU-treated lesional specimens at 24 hours, using immunohistochemical staining for Ki-67, PCNA, bcl-2, and caspase-3, as well as y2HAX and TUNEL assays. The proliferation rate will be calculated from these results.|at 24 hours after the first infusion|Attempts to stain AGT and caspase 3 were unsuccessful and there were no remaining tissues for other outcomes.|||||
799913|NCT00961220|Secondary|Changes in the Apoptosis|Comparing skin biopsy specimens of BCNU-protected CTCL lesional specimens vs BCNU-treated lesional specimens at 48 hours, using immunohistochemical staining for Ki-67, PCNA, bcl-2, and caspase-3, as well as y2HAX and TUNEL assays. The apoptotic index will be calculated from these results.|at 48 hours after the first infusion|Attempts to stain AGT and caspase 3 were unsuccessful and there were no remaining tissues for other outcomes.|||||
799914|NCT00961220|Secondary|Changes in the Apoptosis|Comparing skin biopsy specimens of BCNU-protected CTCL lesional specimens vs BCNU-treated lesional specimens at 24 hours, using immunohistochemical staining for Ki-67, PCNA, bcl-2, and caspase-3, as well as y2HAX and TUNEL assays. The apoptotic index will be calculated from these results.|at 24 hours after the first infusion|Attempts to stain AGT and caspase 3 were unsuccessful and there were no remaining tissues for other outcomes.|||||
799915|NCT00961220|Secondary|Changes in AGT (O6-alkylguanine DNA Alkyltransferase) Activity|Examine AGT depletion at baseline, 24 hrs or 48 hrs, and 1 week after the first Infusion of O6BG. AGT levels will be determined by biochemical activity assay.|1 week after the first infusion|Attempts to stain AGT and caspase 3 were unsuccessful and there were no remaining tissues for other outcomes.|||||
799916|NCT00961220|Secondary|Changes in AGT (O6-alkylguanine DNA Alkyltransferase) Activity|Examine AGT depletion at baseline, 24 hrs or 48 hrs, and 1 week after the first Infusion of O6BG. AGT levels will be determined by biochemical activity assay.|48 hours after the first infusion|Attempts to stain AGT and caspase 3 were unsuccessful and there were no remaining tissues for other outcomes.|||||
799917|NCT00961220|Secondary|Changes in AGT (O6-alkylguanine DNA Alkyltransferase) Activity|Examine AGT depletion at baseline, 24 hrs or 48 hrs, and 1 week after the first Infusion of O6BG. AGT levels will be determined by biochemical activity assay.|24 hours after the first infusion|Attempts to stain AGT and caspase 3 were unsuccessful and there were no remaining tissues for other outcomes.|||||
799918|NCT00961220|Secondary|Changes in AGT (O6-alkylguanine DNA Alkyltransferase) Activity|Examine AGT depletion at baseline, 24 hrs or 48 hrs, and 1 week after the first Infusion of O6BG. AGT levels will be determined by biochemical activity assay.|Baseline|Attempts to stain AGT and caspase 3 were unsuccessful and there were no remaining tissues for other outcomes.|||||
799935|NCT00961350|Secondary|The Number of Subjects With “Treatment Success”|Those Subjects Without Gastric Ulcers and Without Upper Gastrointestinal (UGI) Adverse Events leading to discontinuation.|6 Months|Intent to Treat Population||participants|||Number
820715|NCT01147497|Secondary|Acceptability of Discomfort Associated With Insertion||assessed at one week after insertion and at one month after insertion||||||
799919|NCT00961220|Primary|Overall Response Rate|"Based on changes in modified SWAT assessment, patient responses will be classified as complete clinical response (CCR), partial response (PR), stable disease (SD), or progressive disease (PD). SWAT provides an accurate and reproducible assessment of cutaneous disease involvement based on body surface area of involvement and lesional thickness.
CCR: No evidence of disease, 100% improvement for a duration of at least 4 weeks. PR: Greater than or equal to 50% decrease in SWAT score compared to baseline and improvement is maintained for at least 4 weeks. SD: Less than 50% decrease in SWAT score compared to baseline. PD: Increase of greater or equal to 25% of the SWAT score compared to baseline while the patient is actively taking the study drug"|Up to 2 weeks after completion of study treatment|Intention to treat||participants|||Number
799920|NCT00961233|Primary|Tissue Eosinophil Counts|Level of tissue eosinophil counts (measured in number of eosinophils per high-power microscopy field) on esophageal biopsy after treatment|8 weeks|||# of eosinophils per high-power field||Standard Deviation|Mean
799921|NCT00961233|Secondary|Adrenal Insufficiency|Adrenal insufficiency as measured by a standard cortisol stimulation test (using 0.25 mg cosyntropin IV and baseline and 60 minute post-injection serum cortisol measurements) after treatment. A rise in serum cortisol concentration after to a peak of ≥18 mcg/dL was considered normal; a smaller rise than this was considered adrenal insufficiency.|8 weeks|||participants|||Number
799922|NCT00961259|Primary|The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞)|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant. For the dosing group, Fenofibric Acid 35 mg (35 mg Dose-adjusted to 105 mg), the AUC(0-∞) values were dose-adjusted in order to assess pharmacokinetic linearity.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.|Pharmacokinetic analyses of fenofibric acid are based on 53 out of the 54 subjects who completed the study.||ng-hr/mL||Standard Deviation|Mean
799923|NCT00961259|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule. For the dosing group, Fenofibric Acid 35 mg (35 mg Dose-adjusted to 105 mg), the [AUC(0-t)] values were dose-adjusted in order to assess pharmacokinetic linearity.|serial pharmacokinetic blood samples drawn immediately prior to dosing and then 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours after dose administration|Pharmacokinetic analyses of fenofibric acid are based on 53 out of the 54 subjects who completed the study.||ng-hr/mL||Standard Deviation|Mean
799924|NCT00961259|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that the drug reaches in the plasma. For the dosing group, Fenofibric Acid 35 mg (35 mg Dose-adjusted to 105 mg), the Cmax values were dose-adjusted in order to assess pharmacokinetic linearity.|serial pharmacokinetic blood samples drawn immediately prior to dosing and then 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours after dose administration|Pharmacokinetic analyses of fenofibric acid are based on 53 out of the 54 subjects who completed the study.||ng/mL||Standard Deviation|Mean
799925|NCT00961298|Secondary|Irritable Bowel Syndrome Severity Scoring System|This is a 4 item Likert scale with each assessment being 100 mm scored from measuring from 0 to 400. Higher numbers indicate worse outcome.|endpoint [12 weeks]|||scores on a scale||Standard Deviation|Mean
799926|NCT00961298|Secondary|Irritable Bowel Syndrome-Quality of Life Scale|"The IBS-QOL consists of 34 items, each with a five-point response scale. Ratings range from 1 not at all to 5 extremely or a great deal Higher responses on the scale indicate worse outcome. A minimal total score would be 34, maximum 170."|endpoint [12 weeks]|||scores on a scale||Standard Deviation|Mean
799927|NCT00961298|Secondary|Hamilton Anxiety Rating Scale|"The HAM-A is a 14 question scale with five responses. Responses range from 0 not present to 4 very severe. The total score ranges from 0 to 56. Higher values represent a worse outcome."|endpoint [12 weeks]|||scores on a scale||Standard Deviation|Mean
799928|NCT00961298|Primary|Clinical Global Impression Scale|"The scale consists of two parts the first part being Severity of Illness and the second part is Global Improvement. We report the Global improvement scale.
The Global Improvement is a 1-7 change scale of global improvement since inclusion in the project ranging with 1 very much improved, 4 no change, and 7 very much worse."|endpoint [12 weeks]|per protocol||scores on a scale||Standard Deviation|Mean
799929|NCT00961311|Secondary|Device Success|Device Success defined as successful delivery of the balloon to the target lesion, dilatation of the lesion using the study device, and no evidence of arterial perforation, dissection, arrhythmias, or reduction in blood flow.|1-3 days|||Percent of Participants|||Number
799930|NCT00961311|Secondary|Vessel Perforation (Clinical)|Clinical vessel perforation is classified as requring additional treatment, or resulting in significant pericardial effusion, acute closure, myocardial infarction, or death.|1-3 days|||Percent of Participants|||Number
799931|NCT00961311|Secondary|Major Adverse Cardic Events (MACE)|Major Adverse Cardiac Events (MACE) defined as death, myocardial infarction, emergent coronary bypass surgery, or clinically-driven repeat target lesion revascularization by percutaneous or surgical methods.|1-3 days|||Percent of Participants|||Number
799932|NCT00961311|Primary|Procedural Success|Procedural Success defined as delivery of the balloon to the target lesion, no evidence of perforation or dissection and restoration of normal blood flow at the end of the procedure.|1-3 days|||Percent of Participants|||Number
799933|NCT00961350|Secondary|The Number of Participants With Heartburn Resolution at 6 Months, ie no Heartburn Symptoms During the Last 7 Days Prior to the Visit|"Subjects were asked whether heartburn symptoms within the 7 days prior to the visit were:
none: no symptoms
mild: awareness of symptom, but easily tolerated
moderate: discomforting symptom sufficient to cause interference with normal activities (including sleep)
severe: incapacitating symptom, with inability to perform normal activities (including sleep) Heartburn was defined as a burning feeling rising from the stomach or lower part of the chest towards the neck."|6 Months|Intent to Treat (ITT) Population||participants|||Number
799934|NCT00961350|Secondary|The Number of Participants Discontinuing From the Study Due to NSAID-Associated Upper GI Adverse Events|The Number of Participants Discontinuing from the Study Due to non-steroidal anti-inflammatory drug (NSAID)-Associated Upper GI Adverse Events during the treatment period|6 months|Intent to Treat (ITT) Population||participants|||Number
799937|NCT00961350|Primary|Number of Participants With Gastric Ulcer Confirmed by Endoscopy(EC) Aspirin 325 mg|The primary efficacy endpoint was the number of subjects with gastric ulcers at any time throughout 6 months of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter (measured by close application of open endoscopic biopsy forceps) with unequivocal crater depth. A subject is considered to have completed the study if all scheduled assessments up through the 6 month visit have been performed or if the endpoint of gastric ulcer confirmed by endoscopy has been reached.|6 months|Intent to Treat (ITT) Population||participants|||Number
799938|NCT00961402|Secondary|PHQ-9|Continuous measure of depression. Scoring is on a scale of 0-27 1-4 Minimal depression 5-9 Mild depression 10-14 Moderate depression 15-19 Moderately severe depression 20-27 Severe depression|6 Months|||Score on a scale||Standard Deviation|Mean
799939|NCT00961402|Secondary|Edinburgh Postnatal Depression Scale|This scale is a continuous measure of postpartum depression. Range is 0-30 and a score of 10 or above may be considered depressed. Higher scores indicate higher depression.|6 Months|||Score on a scale||Standard Deviation|Mean
799940|NCT00961402|Secondary|7-Day Physical Activity Recall Interview|Physical activity during previous 7 days. This measure does not have a range given it is directly dependent upon number of minutes of physical activity per week. The intensity ranges from moderate (similar to a brisk walk), hard (similar to a jog), and very hard (similar to a run).|6 months|||Number of physical activity minutes||Standard Deviation|Mean
799941|NCT00961402|Primary|Structured Clinical Interview for DSM-IV Axis I Disorders|This measure was used to determine if participants met the diagnostic criteria for postpartum depression. This is a yes/no diagnostic tool and our data indicate percentage who meet criteria for depression.|6 months|||percentage of participants|||Number
799942|NCT00961415|Secondary|Quality of Life|European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire–Cancer 30 (EORTC QLQ-C30): included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). The European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire–Lung Cancer 13 [EORTC QLQ-LC13]consisted of 1 multi-item scale and 9 single items that assessed the specific symptoms (dyspnea, cough, hemoptysis, and site specific pain), side effects (sore mouth, dysphagia, neuropathy, and alopecia), and pain medication use of lung cancer participants receiving chemotherapy. Scale score range: 0 to 100. Higher symptom score = greater degree of symptom severity. QOL was assessed using Pre-Induction Baseline (Pre-ind BL), Maintenance (MTC), End of study (EOS) cycles.|Up to 21 months|The ITT population included all the participants that were randomized.||Score on scale||Standard Deviation|Mean
799943|NCT00961415|Secondary|Number of Participants With Marked Laboratory Abnormalities|Marked laboratory abnormalities were defined as those values that were outside the reference range and showed a clinically relevant change from Baseline. The reference range for Platelets was 100-550 (10^9/L), for White blood cells (WBC) was 3.0-18.0 (10^9/L), for Lymphocytes was 0.70-7.60 (10^9/L), and Neutrophil 1.50-9.25 (10^9/L ).|Up to 21 months|The safety population comprised of all participants who received at least one dose of study medication. Participants who received induction treatment and were not randomised to maintenance treatment are also included in analysis.||Participants|||Number
799944|NCT00961415|Secondary|Incidence of Adverse Events and Serious Adverse Event|An adverse events (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. An serious adverse event (SAE) is any experience that suggests a significant hazard, contraindication, side effect, or precaution.|Up to 21 months|The safety population comprised of all participants who received at least one dose of study medication. Participants who received induction treatment and were not randomised to maintenance treatment are also included in analysis.||Participants|||Number
799945|NCT00961415|Secondary|Duration of Disease Control During Maintenance Treatment Phase|Duration of disease control is defined as the time in months from randomization to the earlier of documented PD or death due to any cause. Tumor assessment was done before Cycle 3, at Cycle 2 of maintenance therapy and every nine weeks thereafter.|Up to 21 months|The ITT population included all the participants that were randomized.||Months||95% Confidence Interval|Median
799946|NCT00961415|Secondary|Duration of Response During Maintenance Treatment Phase|Duration of response is defined as the time in months from the initial start of response PR or better to the earlier of documented PD or death due to any cause. Participants who had neither progressed nor died at the date of clinical cutoff, who withdrew from the study, were lost to follow-up, or were without documented disease progression were censored at the date of the last available tumor assessment. The analysis was based on all participants with measurable disease at baseline who achieved response.Tumor assessment was done before Cycle 3, at Cycle 2 of maintenance therapy and every nine weeks thereafter.|Up to 21 months|The ITT population included all the participants that were randomized.Participants available at particular time point for assessment were included in the analysis.||Months||95% Confidence Interval|Median
799947|NCT00961415|Secondary|Best Overall Response Rate During Maintenance Treatment Phase|The best overall response rate (BORR) is defined as the percentage of participants having achieved confirmed Complete Response (CR) and Partial Response (PR) as the best overall response. CR was defined as complete disappearance of all target lesions and non-target disease. PR was defined as a greater than or equal to (≥) 30% decrease under baseline of the sum of diameters of all target lesions. Stable disease (SD) is defined as steady state of disease with neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD).Tumor assessment was done before Cycle 3, at Cycle 2 of maintenance therapy and every nine weeks thereafter.|Up to 21 months|The ITT population which included all the participants that were randomized.||percentage of participants||95% Confidence Interval|Number
799948|NCT00961415|Secondary|Overall Survival During Maintenance Treatment Phase|Overall survival (OS) is assessed from the date of first induction treatment until the date of death. Tumor assessment was done before Cycle 3, at Cycle 2 of maintenance therapy and every nine weeks thereafter.|Up to 21 months|The ITT population included all the participants that were randomized.||Months||95% Confidence Interval|Median
820716|NCT01147497|Secondary|Time for Insertion Procedure||assessed immediately after IUD insertion||||||
799949|NCT00961415|Primary|Progression Free Survival During Maintenance Treatment Phase|Progression free survival (PFS) is defined as the time from randomization to the date of documented disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) , or the date of occurrence of a second primary cancer, or date of death from any cause, whichever comes first. Progression is defined using (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, the appearance of new lesions and increase of at least 5 mm in the sum of diameters of target lesions.Tumor assessment was done before Cycle 3, at Cycle 2 of maintenance therapy and every nine weeks thereafter.|Up to 21 months|The ITT population included all the participants that were randomized.||Months||95% Confidence Interval|Median
799950|NCT00961441|Secondary|Occurrence of Treatment-Emergent Adverse Events From Starting Study Drug Treatment (Day 1) to up to 14 Days|An Adverse Event (AE) is any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. Treatment emergent means that an AE has begun or got worse after start of Keppra XR administration.|From Starting Study Drug Treatment (Day 1) to up to 14 days|Safety Set includes all subjects who took at least one dose of study medication. The Safety Set is identical to the Intention-to-treat (ITT) population in this study.||Count|||Number
799951|NCT00961441|Primary|Apparent Total Body Clearance (CL/F) of Keppra XR During up to 7 Days of Administration|The Apparent Total Body Clearance (CL/F) was calculated as Dose/ AUCtau. 6 pharmacokinetic samples were taken pre-dose, 1, 2.5, 4, 6 and 10 hours after administration, at Day 4, 5, 6, or 7 of Keppra XR administration.|6 pharmacokinetic samples were taken pre-dose, 1, 2.5, 4, 6 and 10 hours after administration, at Day 4, 5, 6, or 7 of Keppra XR administration.|PK-PP population||L/h||Geometric Coefficient of Variation|Geometric Mean
799952|NCT00961441|Primary|Time of Maximum Plasma Concentration (Tmax) of Keppra XR During up to 7 Days of Administration|The Tmax is the time corresponding to the maximum plasma concentration of Keppra XR. It was directly obtained from the observed concentration versus time curve. 6 pharmacokinetic samples were taken pre-dose, 1, 2.5, 4, 6 and 10 hours after administration, at Day 4, 5, 6, or 7 of Keppra XR administration.|6 pharmacokinetic samples were taken pre-dose, 1, 2.5, 4, 6 and 10 hours after administration, at Day 4, 5, 6, or 7 of Keppra XR administration.|PK-PP population||hours (h)||Full Range|Median
799953|NCT00961441|Primary|Area Under the Plasma Concentration Curve Over a Dosing Interval of 24 Hours (AUCtau) of Keppra XR Normalized by Dose, and by Body Weight and Dose During up to 7 Days of Administration|"AUCtau normalized by 1000 mg dose was calculated as:
AUCtau/(mg dose taken/ 1000 mg Keppra XR).
AUCtau normalized by body weight and dose (1 mg Keppra XR/kg) was calculated as:
AUCtau/(bodyweight (kg)/ mg dose Keppra XR taken).
6 PK samples were taken pre-dose, 1, 2.5, 4, 6 and 10 hours after administration, at Day 4, 5, 6, or 7 of Keppra XR administration. At steady state, reached after 2 days of administration of Keppra XR, the concentrations at 24h postdose is equal to the predose concentration. The predose concentration was used as the 24h concentration to calculate AUCτau."|6 pharmacokinetic samples were taken pre-dose, 1, 2.5, 4, 6 and 10 hours after administration, at Day 4, 5, 6, or 7 of Keppra XR administration.|Pharmacokinetic Per-Protocol (PK-PP) population||µg*h/mL||95% Confidence Interval|Geometric Mean
799954|NCT00961441|Primary|Maximum Concentration at Steady State (Cmax) of Keppra XR Normalized by Dose and by Body Weight and Dose During up to 7 Days of Administration|"The Cmax is the maximum plasma concentration normalized by dose and by body weight and dose.
Cmax normalized by 1000 mg dose was calculated as:
Cmax/(mg dose taken/ 1000 mg Keppra XR).
Cmax normalized by body weight and dose (1 mg Keppra XR/kg) was calculated as:
Cmax/(bodyweight (kg)/ mg dose Keppra XR taken).
Pharmacokonetic (PK) samples were taken predose and 1h, 2.5h, 4h, 6h and 10h after study medication at day 4, 5, 6 or 7 of Keppra XR administration."|6 pharmacokinetic samples were taken pre-dose, 1, 2.5, 4, 6 and 10 hours after administration, at Day 4, 5, 6, or 7 of Keppra XR administration.|Pharmacokinetic Per-Protocol (PK-PP) population||µg/mL||95% Confidence Interval|Geometric Mean
799955|NCT00961532|Secondary|Adverse Events : New Fever >=100.4F, Respiratory Distress or Pulmonary Edema on Chest Radiography, Rash, Hypotension (Systolic BP < 100 mm Hg or New Vasopressor Use or Increase in Vasopressor Dose by >25%)|We prospectively defined acute adverse events as: new fever >=100.4F, respiratory distress or pulmonary edema on chest radiography, rash, hypotension (systolic BP < 100 mm Hg or new vasopressor use or increase in vasopressor dose by >25%). The two patients reported were the only two that sustained any of the prospectively defined adverse events.|within 6 hours of study treatment|||participants|||Number
799956|NCT00961532|Primary|Change in Platelet Activity, Measured in Seconds on PFA-EPI Assay, From Pre to Post-treatment|The Platelet Function Analyzer (PFA) is a commercially available point-of-care assay that measures the time to closure of an aperature. Longer time to closure indicates less platelet activity. EPI denotes epinephrine (as opposed to adenosine diphosphate) as the stimulant to platelet aggregation. In our laboratory, a time to closure of at least 172 seconds in consistent with an aspirin effect.|60 minutes after treatment start|||seconds||Standard Error|Mean
799957|NCT00961571|Secondary|Objective Response|complete response, partial response or stable disease per RECIST criteria.|8 weeks||03/2017||||
799958|NCT00961571|Secondary|Overall Survival|Overall survival (OS) will be measured as the number of days between each patient's enrollment and his/her date of death.|2 years||03/2017||||
799959|NCT00961571|Secondary|Toxicity||24 months||03/2017||||
799960|NCT00961571|Primary|Progression-free Survival|Progression-free survival (PFS) will be measured as the number of days between each patient's enrollment and his/her date of progression or date of death.|24 months|Progression-free survival (PFS) will be measured as the number of days between each patient's enrollment and his/her date of progression or date of death.||participants||Full Range|Median
799961|NCT00961636|Secondary|Number of Participants With Maximum GFSS ≥4 During the Post-withdrawal Period|Flushing symptoms were recorded using participant's response to the Global Flushing Severity Score (GFSS), which assesses the overall severity of the flushing experience (including redness, warmth, tingling, or itching) using a scale with response categories of None, Mild, Moderate, Severe, and Extreme. The categories were supplemented with numbers 0 to 10 to allow for greater precision within each category (None=0, Mild=1-3, Moderate=4-6, Severe=7-9, Extreme=10). The daily response was recorded in the morning, and reflected the symptoms experienced during the previous 24 hours.|Week 21 to Week 32|Analysis performed using the Full Analysis Set (FAS) population which included all randomized participants that did not have a withdrawal visit and/or did not have at least 1 GFSS score during the post-withdrawal period (Weeks 21 to 32).||Participants|||Number
799962|NCT00961636|Primary|Number Participants With Days Per Week With Global Flushing Severity Score (GFSS) ≥4 Partitioned Into 6 Categories During the Postwithdrawal Period|Flushing symptoms were recorded using participant's response to the Global Flushing Severity Score (GFSS), which assessed the overall severity of the flushing experience, using a scale of 0 (no symptom) to 10 (extreme). The number of days/week was derived as: 7*(total number of days with GFSS ≥4 across Weeks 21-32 divided by the total number of days with nonmissing GFSS across the same period). The number of days/week with a GFSS ≥4 for each participant was listed in 1 of the following 6 categories: 0, >0 to 0.5, >0.5 to 1, >1 to 2, >2 to 3, and >3 days per week.|Week 21 to Week 32|Analysis performed using the Full Analysis Set (FAS) population which included all randomized participants that did not have a withdrawal visit and/or did not have at least 1 GFSS score during the post-withdrawal period (Weeks 21 to 32).||Participants|||Number
799963|NCT00961649|Primary|Mean Change in Intraocular Pressure (IOP) From Baseline to Each of the Assessment Time Points (8 AM, +2 Hrs, +7 Hrs, and +9 Hrs) at Week 6 - Brinz/Brim, Brinz+Brim|The study drug was instilled at 8 AM and +7 hours relative to the 8 AM dosing (approximately 15 minutes after conducting the IOP measurements). Intraocular pressure was measured by Goldmann applanation tonometry. One eye from each patient was chosen as the study eye and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Per-Protocol (PP) analysis data set was pre-specified for the comparison of Brinz/Brim to Brinz+Brim.|Baseline, Week 6|PP: All subjects who received study drug, satisfied inclusion/exclusion criteria, and had at least 1 scheduled on-therapy visit. Individual subject visits or data points were excluded if protocol criteria were violated at a subset of the subject's visits and the violations, in the opinion of the Medical Monitor, did not invalidate remaining visits.||millimeters mercury (mmHg)||Standard Error|Least Squares Mean
799964|NCT00961649|Primary|Mean Change in Intraocular Pressure (IOP) From Baseline to Each of the Assessment Time Points (8 AM, + 2 Hrs, + 7 Hrs, and + 9 Hrs) at Week 6 - Brinz/Brim, Brinz, Brim|The study drug was instilled at 8 AM and +7 hours relative to the 8 AM dosing (approximately 15 minutes after conducting the IOP measurements). Intraocular pressure was measured by Goldmann applanation tonometry. One eye from each patient was chosen as the study eye and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Intent-to-Treat (ITT) analysis data set was pre-specified for the comparison of Brinz/Brim to its individual components (Brinz and Brim).|Baseline, Week 6|ITT: All subjects who received study drug and had at least 1 scheduled on-therapy study visit.||millimeters mercury (mmHg)||Standard Error|Least Squares Mean
799965|NCT00961662|Secondary|Body Weight Loss (Compared to Baseline)||6 months||||||
799966|NCT00961662|Secondary|A Decrease of Fasting Plasma Glucose (FPG) Level Compared With Baseline Level at Any Time Point Over the Duration of the Study||6 months||||||
799967|NCT00961662|Secondary|A Decrease of ≥1% in HbA1c Level in Any of the Naturlose (Tagatose) Treatment Groups at Any Time Point Over the Duration of the Study||8 months||||||
799968|NCT00961662|Secondary|A Decrease of ≥0.5% in HbA1c Level at Each Study Visit||6 months||||||
799969|NCT00961662|Secondary|Effects of Naturlose (Tagatose) on Other Glycemic Control Measurements Such as Plasma Glucose Concentrations and Plasma Lipids at Each Study Visit||6 months||||||
799970|NCT00961662|Primary|Change From Baseline HbA1c After Six Months of Treatment in Patients With Type 2 Diabetes Mellitus|The primary efficacy parameter was a dichotomous variable: the treatment success as measured by a reduction from baseline HbA1c by at least 0.5 units after six months of treatment (i.e.,0.5% reduction in HbA1c after six months of treatment).|6 months from baseline|ITT Population||participants|||Number
799971|NCT00961805|Secondary|Self-image - Body Dysmorphic Disorder Examination Questionnaire|scored between 0 from 168, with higher scores indicating greater level of dissatisfaction with self-image|Baseline, after 16 weeks and after 32 weeks|||units on a scale||Standard Deviation|Mean
799972|NCT00961805|Secondary|Depression - Beck Inventory|score between 0 from 63, with higher score indicating greater depression|Baseline, after 16 weeks and after 32 weeks|||units on a scale||Standard Deviation|Mean
799973|NCT00961805|Secondary|Quality of Life - SF-36 - Mental Health|score between 0 from 100, with higher scores denoting better quality of life|baseline, after 16 weeks and after 32 weeks|||units on a scale||Standard Deviation|Mean
799974|NCT00961805|Secondary|Quality of Life - SF-36 - Emotional Aspects|score between 0 from 100, with higher scores denoting better quality of life|baseline, after 16 weeks and after 32 weeks|||units on a scale||Standard Deviation|Mean
799975|NCT00961805|Secondary|Quality of Life - SF-36 - Social Aspects|score between 0 from 100, with higher scores denoting better quality of life|baseline, after 16 weeks and after 32 weeks|||units on a scale||Standard Deviation|Mean
799976|NCT00961805|Secondary|Quality of Life - SF-36 - Vitality|score between 0 from 100, with higher scores denoting better quality of life|baseline, after 16 weeks and after 32 weeks|||units on a scale||Standard Deviation|Mean
799977|NCT00961805|Secondary|Quality of Life - Sf-36 - General Health State|score between 0 from 100, with higher scores denoting better quality of life|baseline, after 16 weeks and after 32 weeks|||units on a scale||Standard Deviation|Mean
799978|NCT00961805|Secondary|Quality of Life - Sf-36 - Pain|score between 0 from 100, with higher scores denoting better quality of life|baseline, after 16 weeks and after 32 weeks|||units on a scale||Standard Deviation|Mean
799979|NCT00961805|Secondary|Quality of Life - SF-36 - Physical Limitation|score between 0 from 100, with higher scores denoting better quality of life|baseline, after 16 weeks and after 32 weeks|||units on a scale||Standard Deviation|Mean
799980|NCT00961805|Secondary|Quality of Life - SF-36 -Functional Capacity|score between 0 from 100, with higher scores denoting better quality of life|baseline, after 16 weeks and after 32 weeks|||units on a scale||Standard Deviation|Mean
799981|NCT00961805|Secondary|Quality of Life - Fibromyalgia Impact Questionnaire|score between 0 from 10 with 0 indicating no impairment and 10 indicating maximum impairment|baseline, after 16 weeks and after 32 weeks|||units on a scale||Standard Deviation|Mean
799982|NCT00961805|Secondary|Function - 6 Minute Walk Test|meters traveled on a 20-meter course over a six-minute period|baseline, after 16 weeks and after 32 weeks|||meters||Standard Deviation|Mean
799983|NCT00961805|Primary|Visual Analog Scale for Pain|score between 0 and 100 where 0 is no pain and 100 in unbearable pain|baseline, after 16 weeks and after 32 weeks|||mm||Standard Deviation|Mean
799984|NCT00961896|Primary|Number of Participants With at Least Partial Clinical Clearance (Part I)|Clinical response parameters were defined as (i) complete response (i.e., there is no longer any visible evidence of a lesion consistent with BCC at this site), (ii) partial response (i.e., although a BCC still remains at this site, it has demonstrated a visible decrease in size compared with baseline), and (iii) no response / worsening (i.e., the BCC has not demonstrated any visible decrease in size compared with baseline).|day 8, day 15, day 22, day 29|All part I participants were included in the analysis.||Number of participants|||Number
799985|NCT00961896|Secondary|Change From Baseline in Tumor Measurements (by Tumor) (Part II)|Measurement of the tumor size, volume and color by standardized digital photography, using dermatoscopic, macroscopic and 3D images of the BCCs. Photographic analysis was conducted by QuantifiCare. The volume of a lesion was measured with a special device, the “3D LIFEVIZ Micro system”, which uses a lens splitter to produce two images of the skin surface, captured at the same time, with viewing angle differences close to human vision. A stereovision algorithm is then applied to reconstruct and quantitatively analyze the skin surface in 3D. A negative change from baseline indicates improvement.|4 weeks, 6 weeks, 9 weeks|Part II participants with evaluable data (n=3,6) were included in the analysis.||Percent change in tumor measurement|Participants|Standard Deviation|Mean
799986|NCT00961896|Secondary|Change From Baseline in Tumor Measurements (by Tumor) (Part I)|Measurement of the tumor size, volume and color by standardized digital photography, using dermatoscopic, macroscopic and 3D images of the BCCs. Photographic analysis was conducted by QuantifiCare. The volume of a lesion was measured with a special device, the “3D LIFEVIZ Micro system”, which uses a lens splitter to produce two images of the skin surface, captured at the same time, with viewing angle differences close to human vision. A stereovision algorithm is then applied to reconstruct and quantitatively analyze the skin surface in 3D. A negative change from baseline indicates improvement.|4 weeks|All part I participants were included in this analysis.||Percent change in tumor measurement|Participants|Standard Deviation|Mean
799987|NCT00961896|Secondary|Change From Baseline in Tumor Measurements (Part II)|Measurement of the tumor size, volume and color by standardized digital photography, using dermatoscopic, macroscopic and 3D images of the BCCs was done by participant where if a participant had more than one tumor, for each of these tumors, the change from baseline was calculated (% change). From these values, the mean was calculated to get only one result per participant. Then for all the participants (n=8 both for LDE and vehicle), the mean was calculated.. Photographic analysis was conducted by QuantifiCare. The volume of a lesion was measured with a special device, the “3D LIFEVIZ Micro system”, which uses a lens splitter to produce two images of the skin surface, captured at the same time, with viewing angle differences close to human vision. A stereovision algorithm is then applied to reconstruct and quantitatively analyze the skin surface in 3D. A negative change from baseline indicates improvement.|4 weeks, 6 weeks, 9 weeks|Part II participants with evaluable data (n=3,6) were included in the analysis.||percent change in tumor measurement||Standard Deviation|Mean
799988|NCT00961896|Secondary|Change From Baseline in Tumor Measurements (Part I)|Measurement of the tumor size, volume and color by standardized digital photography, using dermatoscopic, macroscopic and 3D images of the BCCs was done by participant where if a participant had more than one tumor, for each of these tumors, the change from baseline was calculated (% change). From these values, the mean was calculated to get only one result per participant. Then for all the participants (n=8 both for LDE and vehicle), the mean was calculated. Photographic analysis was conducted by QuantifiCare. The volume of a lesion was measured with a special device, the “3D LIFEVIZ Micro system”, which uses a lens splitter to produce two images of the skin surface, captured at the same time, with viewing angle differences close to human vision. A stereovision algorithm is then applied to reconstruct and quantitatively analyze the skin surface in 3D. A negative change from baseline indicates improvement.|4 weeks|All part I participants were included in the analysis.||Percent change in tumor measurement||Standard Deviation|Mean
799989|NCT00961896|Primary|Percentage of BCCs With Complete and at Least Partial Clinical Clearance|Clinical response parameters were defined as (i) complete response (i.e., there is no longer any visible evidence of a lesion consistent with BCC at this site), (ii) partial response (i.e., although a BCC still remains at this site, it has demonstrated a visible decrease in size compared with baseline), and (iii) no response / worsening (i.e., the BCC has not demonstrated any visible decrease in size compared with baseline).|4 weeks, 6 weeks, 9 weeks|All participants were analyzed.||Percentage of BCCs|Participants||Number
799990|NCT00962000|Secondary|Kt/V Determined From Measurements of Ionic Dialysance|Kt/VID was determined for all study treatments at 2 of the 3 centers using on-line clearance measurements (Gambro Diascan or Fresenius On-line Clearance Monitor).|4 weeks|||Kt/VID|Treatments|Standard Deviation|Mean
799991|NCT00962000|Secondary|Delivered Equilibrated Kt/Vurea (eKt/V at Dialysate Flow Rates of 600 mL/Min and 800 mL/Min.|The dose of dialysis delivered in a single treatment is commonly expressed in terms of Kt/Vurea, where K is the clearance of urea, t is the treatment time, and V is the urea distribution volume. The formula for equilibrated Kt/Vurea takes urea rebound into consideration. Delivered Kt/Vurea was determined from pre-and post-dialysis BUN concentrations measured during the final treatment session of each group (ABAB or BABA).|4 weeks|||equilibrated Kt/Vurea (eKt/V)|Treatments|Standard Deviation|Mean
799992|NCT00962000|Primary|Delivered Single-pool Kt/Vurea (spKt/V) at Dialysate Flow Rates of 600 mL/Min and 800 mL/Min.|"The dose of dialysis delivered in a single treatment is commonly expressed in terms of Kt/Vurea, where K is the clearance of urea, t is the treatment time, and V is the urea distribution volume. When urea is removed from a single compartment during dialysis, it is called the single-pool Kt/V. Delivered Kt/Vurea was determined from pre-and post-dialysis BUN concentrations measured during the final treatment session of each group (ABAB or BABA)."|4 weeks|||single-pool Kt/Vurea (spKt/V)|Treatments|Standard Deviation|Mean
799993|NCT00962013|Secondary|Post-surgery Femoral Crack/Fracture and Subsidence Rate||Post-op to 5 years|Post-surgery femoral crack/fracture and subsidence rate were assessed by hip.||percentage of hips|hips||Number
799994|NCT00962013|Primary|Femoral Stem Fracture||5 years|Participants who received the Restoration Modular Hip System.||femoral stem fractures|||Number
800251|NCT00963599|Secondary|Mean Change From Baseline in Daytime Nasal Congestion Score|Patients were asked to rate the nasal symptom of Congestion daily on a 4-point scale (0 (best) to 3 (worst)).|Baseline and Week 2|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.||Units on a Scale||95% Confidence Interval|Least Squares Mean
799995|NCT00962013|Secondary|SF-36 Health Status Survey: Role - Physical|"Consists of 8 subscores all with a range of 0-100; a higher score indicates a better health state:
The subscores are: 1 - Physical Functioning, 2 - Role-Physical, 3 - Bodily Pain, 4 - General Health, 5 - Vitality, 6 - Social Functioning, 7- Role-Emotional, 8 - Mental Health
This Secondary Outcome Measure is focused on the Role-Physical score."|pre-op, 2 year and 5 year|SF-36 Scores were assessed for each hip. (One hip did not have a pre-operative SF-36)||units on a scale|hips|Standard Deviation|Mean
799996|NCT00962013|Secondary|Harris Hip Score|"Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score less than or equal to 79 is considered fair-poor.
90 - 100 = excellent
80 - 89 = good
70 - 79 = fair
0 - 69 = poor"|pre-op and 5 years|||units on a scale|hips|Standard Deviation|Mean
799997|NCT00962013|Secondary|Radiographic Stability|Absence of a radiolucent lines ≥ 2mm around the entire stem in AP or ML view.|5 years|41 hips had fully evaluable radiographs at the 5 year interval; 40 out of the 41 hips are stable.||percentage of stable hips|hips|95% Confidence Interval|Number
799998|NCT00962013|Primary|Stem Survivorship (%)|Failure is defined by stem revision for any cause.|5 years|Participants with 5 year follow-up evaluations or participant had a stem revision before they reached 5 years.||stem survivorship percentage at 5 years|hips|90% Confidence Interval|Number
799999|NCT00962065|Secondary|Change From Baseline at Day 28 in Triglycerides||Baseline to Day 28|||mg/dL||95% Confidence Interval|Mean
800000|NCT00962065|Secondary|Change From Baseline at Day 28 in Mean Arterial Pressure||Baseline to Day 28|||mm Hg||95% Confidence Interval|Mean
800001|NCT00962065|Secondary|Change From Baseline at Day 28 in Plasma Fructosamine Level||Baseline to Day 28|||µmol/L||95% Confidence Interval|Mean
800002|NCT00962065|Secondary|Change From Baseline at Day 28 in Plasma HbA1c||Baseline to Day 28|||Percent||95% Confidence Interval|Mean
800003|NCT00962065|Secondary|Change From Baseline at Day 29 in Fasting Plasma Glucose||Baseline to Day 29|||mg/dL||95% Confidence Interval|Mean
800004|NCT00962065|Primary|Change From Baseline at Day 28 in 24-hour Urinary Glucose Excretion|To assess 24-hour urinary glucose excretion, urine was collected over a 24-hour period and evaluated for glucose concentration.|Baseline to Day 28|||grams||95% Confidence Interval|Mean
800005|NCT00962104|Secondary|Change From Baseline in the Hamilton Depression Rating Scale-17 Items (HAMD-17 Total) up to 10 Weeks|The HAMD-17 was used to assess the severity of depression and its improvement during the course of therapy. Each item was evaluated and scored using either a 5-point scale of 0 (not present) to 4 (very severe) or a 3-point scale of 0 (not present) to 2 (marked). Higher scores indicate greater symptom severity. The total score is the sum of the scores from HAMD-17 Items 1 through 17. The total score may range from 0 (not at all depressed) to 52 (severely depressed). Higher scores indicate a greater degree of symptom severity.|Baseline, up to 10 weeks|All randomized participants with a baseline and at least 1 post-baseline HAMD-17 result within each treatment group, last observation carried forward (LOCF) were included in the analysis.||units on a scale||Standard Deviation|Mean
800006|NCT00962104|Secondary|Change From Baseline in the Hamilton Anxiety Rating Scale-14 Items (HAMA-14) up to 10 Weeks|Clinician-administered rating scale that assesses severity of anxiety and its improvement (or change) during course of treatment (Hamilton 1959; Riskind et al. 1987). Scale consists of 14 items that provide an overall measure of general anxiety, including psychic anxiety and somatic anxiety. Investigator talked to participant about participant's symptoms over previous week before study visit. Each item is rated on a 5-point scale of 0 (absent) to 4 (very severe). Total score=sum of 14 items and ranges from 0 (normal) to 56 (severe). Higher scores indicate a greater degree of symptom severity.|Baseline, up to 10 weeks|All randomized participants with a baseline and at least 1 post-baseline HAMA-14 result within each treatment group, last observation carried forward (LOCF) were included in the analysis.||units on a scale||Standard Deviation|Mean
800007|NCT00962104|Secondary|Clinical Global Impression-Attention Deficit/Hyperactivity Disorder-Improvement Scale (CGI-ADHD-I) up to 10 Weeks|The CGI-ADHD-I is a single-item clinician rating of the clinician’s assessment of the participant’s improvement in ADHD symptoms in relation to the clinician’s total experience with ADHD participants. Measures total improvement (or worsening) of a participant's ADHD symptoms from the beginning of treatment (1=very much improved to 7=very much worsened).|Up to 10 weeks|All randomized participants with an endpoint CGI-ADHD-I value within each treatment group, last observation carried forward (LOCF) were included in the analysis.||units on a scale||Standard Deviation|Mean
800008|NCT00962104|Secondary|Change From Baseline in the Clinical Global Impression-Attention Deficit/Hyperactivity Disorder-Severity Scale (CGI-ADHD-S) up to 10 Weeks|The CGI-ADHD-S is a single-item clinician rating of the clinician’s assessment of the overall severity of the participant’s ADHD symptoms in relation to the clinician’s total experience with ADHD participants. Measures severity of the participant's overall severity of ADHD symptoms (1=normal, not at all ill to 7=among the most extremely ill participants).|Baseline, up to 10 weeks|All randomized participants with a baseline and at least 1 post-baseline CGI-ADHD-S result within each treatment group, last observation carried forward (LOCF) were included in the analysis.||units on a scale||Standard Deviation|Mean
800009|NCT00962104|Secondary|Change From Baseline in the Behavior Rating Inventory of Executive Function-Adult Version: Informant (BRIEF-A: Informant) Score up to 10 Weeks|Third-party observer of participant completes 75-item scale. Comprised of 3 subscales. Each item rated on 3-point Likert scale (1=behavior never observed to 3=behavior often observed). Behavioral regulation subscale measures one’s control over behavior (30-90 total score). Metacognition subscale assesses systematic problem-solving ability while sustaining these task-completion efforts in active working memory (40-120 total score). Global executive composite (GEC) subscale rates participant’s GEC in everyday environment (75-225 total score). Higher subscale ratings=greater perceived impairment.|Baseline, up to 10 weeks|All randomized participants with a baseline and at least 1 post-baseline BRIEF-A result within each treatment group, last observation carried forward (LOCF) were included in the analysis.||units on a scale||Standard Deviation|Mean
800102|NCT00962741|Secondary|C-reactive Protein (CRP)|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||mg/Liter (mg/L)||Standard Deviation|Mean
800010|NCT00962104|Secondary|Change From Baseline in the Behavior Rating Inventory of Executive Function-Adult Version: Self Report (BRIEF-A:Self Report) Score up to 10 Weeks|A 75-item standardized self-reported measure comprised of 3 subscales. Each item is rated on a 3-point Likert scale (1=behavior never observed to 3=behavior often observed). Behavioral regulation subscale measures one’s control over behavior (30-90 total score). Metacognition subscale assesses systematic problem-solving ability while sustaining these task-completion efforts in active working memory (40-120 total score). Global executive composite (GEC) subscale rates participant’s GEC in everyday environment (75- 225 total score). Higher subscale ratings=greater perceived impairment.|Baseline, up to 10 weeks|All randomized participants with a baseline and at least 1 post-baseline BRIEF-A result within each treatment group, last observation carried forward (LOCF) were included in the analysis.||units on a scale||Standard Deviation|Mean
800011|NCT00962104|Secondary|The Conners' Adult Attention-Deficit/Hyperactivity Disorder Rating Scale-Self Report: Screening Version (CAARS-S:SV) 18 Item Total Attention-Deficit/Hyperactivity Disorder (ADHD) Symptom Score at 10 Weeks|Participant assessment of symptom severity over past week. Total ADHD symptom score comprises 18 items (sum of inattention [9 items, range: 0-27] and hyperactivity-impulsivity [9 items, range: 0-27] subscales) using 4-point scale (0=not at all/never to 3=very much/very frequently). Total score range: 0 to 54. Higher scores=greater impairment. Least Squares Mean Value based on mixed model repeated measures analysis with term for baseline, country, visit, treatment, and treatment*visit. Baseline included as covariate; thus, treatment difference in observed value is same as change from baseline.|10 weeks|All randomized participants with a baseline and at least 1 post-baseline CAARS-S:SV result were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
800012|NCT00962104|Secondary|The Conners' Adult Attention-Deficit/Hyperactivity Disorder Rating Scale-Investigator Rated: Screening Version (CAARS-Inv:SV) 18-Item Total Attention-Deficit/Hyperactivity Disorder (ADHD) Symptom Score at 10 Weeks|CAARS-Inv:SV assesses symptom severity over past week. Total ADHD symptom score comprises 18 items (sum of inattention [9 items, range: 0-27] and hyperactivity-impulsivity [9 items, range: 0-27] subscales) using a 4-point scale (0=not at all/never to 3=very much/very frequently). Total score range: 0 to 54. Higher scores=greater impairment. Least Squares Mean Value based on mixed model repeated measures analysis with term for baseline, country, visit, treatment, and treatment*visit. Baseline included as a covariate; thus, treatment difference in observed value is same as change from baseline.|10 weeks|All randomized participants with a baseline and at least 1 post-baseline CAARS-Inv:SV result were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
800013|NCT00962104|Secondary|Change From Baseline in the European Quality of Life Questionnaire-5 Dimensions (EQ-5D) Health State Score up to 10 Weeks|The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument. Overall health state score is self-reported using a visual analogue scale marked on a scale of 0 to 100 with 0 representing worst imaginable health state and 100 representing best imaginable health state.|Baseline, up to 10 weeks|All randomized participants with a baseline and at least 1 post-baseline EQ-5D result within each treatment group, last observation carried forward (LOCF) were included in the analysis.||units on a scale||Standard Deviation|Mean
800014|NCT00962104|Secondary|Change From Baseline in the Adult Attention-Deficit/Hyperactivity Disorder Quality of Life-29 (AAQoL) Scores up to 10 Weeks|Participant-reported outcome measure used to examine disease-specific functional impairments and QoL for adults with ADHD. The domains include work functioning, family relationships, social functioning, activities of daily living (that is, driving, managing finances), and psychological adaptation (that is, life satisfaction and self-esteem). Individual items scored on a 5-point scale from 1 (not at all/never) to 5 (extremely/very often). Range of scores for this subscale is 0 to 100. Consistent with the majority of existing QoL measures, higher scores on AAQoL-29 indicate better functioning.|Baseline, up to 10 weeks|All randomized participants with a baseline and at least 1 post-baseline AAQoL result within each treatment group, last observation carried forward (LOCF) were included in the analysis.||units on a scale||Standard Deviation|Mean
800015|NCT00962104|Primary|Change From Baseline in the Conners' Adult Attention-Deficit/Hyperactivity Disorder Rating Scale-Investigator Rated: Screening Version (CAARS-Inv:SV) 18-Item Total Attention-Deficit/Hyperactivity Disorder (ADHD) Symptom Score up to 10 Weeks|CAARS-Inv:SV is a scale that assesses symptom severity over past week. Total ADHD symptom score consisted of 18 items (sum of inattention [9 items, range: 0-27] and hyperactivity-impulsivity [9 items, range: 0-27] subscales) using a 4-point scale (0=not at all/never to 3=very much/very frequently) for total score range of 0 to 54. Higher scores indicate greater impairment.|Baseline, up to 10 weeks|All randomized participants with a baseline and at least 1 post-baseline CAARS-Inv:SV result within each treatment group, last observation carried forward (LOCF) were included in the analysis.||units on a scale||Standard Deviation|Mean
800016|NCT00962208|Secondary|Determine Changes in Other Ocular Parameters (e.g. Corneal Biomechanics and Aberration) Associated With Orthokeratology Lens Wear||2 years||||||
800017|NCT00962208|Secondary|Determine the Incidence of Adverse Effects in Cornea, the Palpebral, Bulbar and Tarsal Conjunctiva in the Study and the Control Groups||2 years||||||
800018|NCT00962208|Primary|Axial Elongation in the Study and Control Subjects Who Completed the Two Years Study|Axial elongation was determined by the change in axial length of the eyeball before and after treatment period. Axial length was measured by the IOLMaster (Zeiss Humphrey, Dublin, CA) 30 minutes after cycloplegia. The measurement of the axial length followed the procedures as recommended by the manufacturer.|2 years|||mm||Standard Deviation|Mean
800019|NCT00962247|Secondary|Energy Intake|Resting metabolic rate was calculated using the activity data from accelerometer (Actigraph) collection. Resting metabolic rate was used to calculate estimated daily energy expenditure. Daily energy expenditure and weight change over the study period was used to estimate energy intake. If weight was stable of the nine weeks, assume energy intake = energy expenditure. A gain of a pound was estimated as equivalent to a positive balance of 3500 calories and a loss of a pound was estimated as equivalent to a negative balance of 3500 calories.|3 days|||calories/day||Standard Error|Mean
800020|NCT00962247|Primary|Physical Activity|Actigraph activity monitors were used to record physical activity over 3 days, in addition to a weekly physical activity diary. Acti-graph counts were used to estimate energy expenditure during waking hours. Counts per minute describes the average rate of counts, with 0 being at rest and higher numbers indicating more vigorous physical activity.|3 days|||counts/minute of physical activity||Standard Error|Mean
822935|NCT01165983|Secondary|Absolute Change in Inflammatory Cytokines and Growth Factors, MCP-1 pg/mL||12 Weeks post-randomization|||pg/mL||Inter-Quartile Range|Median
800021|NCT00962390|Secondary|Change in DAN Prostate Symptom Scale From Baseline at Week 4|The questionnaire is made up of two kinds of questions: intensity of a symptom and bothersomeness of a symptom. Prostate symptoms are addressed in questions 1 - 12 and sexual function in questions 13 - 15. Patients indicate how intense/frequent (scoring 0, 1, 2, or 3; where 0 represents the best case and 3 the worst case) and how bothersome the symptom (scoring 0, 1, 2, or 3; where 0 is 'not at all' and 3 is 'very much'). DAN-PSS total and DAN-PSS total sexual function score were calculated by multiplying the frequency score by the trouble score of each symptom, and then adding the resulting figures. The possible values of DAN-PSS total ranged from 0 to 108 and of DAN-PSS total sexual function score ranged from 0 to 27. A reduction in DAN-PSS total and/or sexual function score is consistent with improved BPH symptoms/sexual functioning.|4 weeks|All randomized subjects who received at least 1 dose of investigational product starting at Baseline, and who had at least 1 post-dose assessment of interest.||units on a scale||Standard Deviation|Mean
800022|NCT00962390|Secondary|Change in I-PSS Total Score From Baseline at Week 4|The International Prostate Symptom Score (I-PSS) is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of 6 answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). The first seven questions of the I-PSS are identical to the questions appearing on the American Urological Association (AUA) Symptom Index which currently categorizes symptoms as follows: Mild (symptom score less than of equal to 7); Moderate (symptom score range 8-19); and Severe (symptom score range 20-35). A reduction in I-PSS Total Score is consistent with improvement in symptoms of BPH.|4 weeks|All randomized subjects who received at least 1 dose of investigational product starting at Baseline, and who had at least 1 post-dose assessment of interest.||units on a scale||Standard Deviation|Mean
800023|NCT00962390|Secondary|Investigators Assessment of Nocturia at Week 4|Investigators were asked to rate participant's change in nocturia since the Baseline Visit.|4 weeks|All randomized subjects who received at least 1 dose of investigational product starting at Baseline, and who had at least 1 post-dose assessment of interest.||number of times urinated at night||Full Range|Median
800024|NCT00962390|Secondary|Participants Assessment of Nocturia at Week 4|Participants were asked to rate their change in nocturia (number of times you wake from sleep to urinate) since the Baseline Visit.|4 weeks|All randomized subjects who received at least 1 dose of investigational product starting at Baseline, and who had at least 1 post-dose assessment of interest.||number of times to urinate at night||Full Range|Median
800025|NCT00962390|Secondary|Change in Total Testosterone Concentration From Baseline at Week 4||4 weeks|All randomized subjects who received at least 1 dose of investigational product starting at Baseline, and who had at least 1 post-dose assessment of interest.||nmol/L||Standard Deviation|Mean
800026|NCT00962390|Secondary|Change in Luteinizing Hormone Concentration From Baseline at Week 4||4 weeks|All randomized subjects who received at least 1 dose of investigational product starting at Baseline, and who had at least 1 post-dose assessment of interest.||IU/L||Standard Deviation|Mean
800027|NCT00962390|Secondary|Change in in Dihydrotestosterone Concentration From Baseline at Week 4||4 weeks|All randomized subjects who received at least 1 dose of investigational product starting at Baseline, and who had at least 1 post-dose assessment of interest.||pg/mL||Standard Deviation|Mean
800028|NCT00962390|Secondary|Change in Post-Void Residual Volume From Baseline at Week 4||4 weeks|All randomized subjects who received at least 1 dose of investigational product starting at Baseline, and who had at least 1 post-dose assessment of interest.||mL||Standard Deviation|Mean
800029|NCT00962390|Secondary|Change in Void Volume From Baseline at Week 4||4 weeks|All randomized subjects who received at least 1 dose of investigational product starting at Baseline, and who had at least 1 post-dose assessment of interest.||mL||Standard Deviation|Mean
800030|NCT00962390|Secondary|Percent Change in Qmax From Baseline at Week 4||4 weeks|All randomized subjects who received at least 1 dose of investigational product starting at Baseline, and who had at least 1 post-dose assessment of interest.||Participants|||Count of Participants
800031|NCT00962390|Secondary|Categorical Change in Qmax From Baseline at Week 4||4 weeks|All randomized subjects who received at least 1 dose of investigational product starting at Baseline, and who had at least 1 post-dose assessment of interest.||Participants|||Count of Participants
800032|NCT00962390|Secondary|Change in Qmax From Baseline at Week 4||4 weeks|All randomized subjects who received at least 1 dose of investigational product starting at Baseline, and who had at least 1 post-dose assessment of interest.||mL/sec||Standard Deviation|Mean
800033|NCT00962390|Secondary|Change in Prostate Volume From Baseline at Week 4|Prostate size as measured by prostate volume as assessed by transrectal ultrasound.|4 weeks|All randomized subjects who received at least 1 dose of investigational product starting at Baseline, and who had at least 1 post-dose assessment of interest.||mL||Standard Deviation|Mean
800034|NCT00962390|Primary|Change From Baseline at Week 4 in Prostate Specific Antigen (PSA) Concentration.|Prostate specific antigen is considered to be the most sensitive measure of S-equol effects on the prostate, due to the expected effects of S-equol on the androgen receptor axis. In this proof-of-concept study, a population of 124 male subjects was estimated to achieve approximately 104 completed subjects (based on an estimated drop-out rate of 15%) to examine the dose-response compared to placebo. A sample size of 26 subjects in each treatment arm was considered to be adequate to observe a trend in this proof-of-concept study.|4 weeks|All Participants who received at least 1 dose of study drug and who had a post-dose PSA assessment at Week 4.||ng/mL||Standard Error|Least Squares Mean
800035|NCT00962585|Post-Hoc|Change From Baseline in Menopause Rating Scale (MRS) - Dryness of Vagina- S-equol Groups Combined|"The following analysis pre-specified the combining of all S-equol groups (S-equol 20 mg total daily dose, 100 mg total daily dose, and 300 mg total daily dose) into a single treatment group. The results from the Wilcoxon-Mann-Whitney test (pair-wise test), based on the change from Baseline at Week 4, are presented.
Note: Dryness of Vagina was assigned a score from 0 to 4 (0 = 'None' and 4 = 'Extremely severe'"|4 weeks from Baseline (Day 0)|||units on a scale||95% Confidence Interval|Mean
800327|NCT00955474|Secondary|HDL Blood Levels at Baseline and Week 8.|HDL levels at Baseline and Week 8. Normal range: 35-100 mg/dl.|8 weeks|Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.||mg/dl||Standard Deviation|Mean
800036|NCT00962585|Secondary|Mean Precentage Change in the Menopause Rating Scale Total Score From Baseline at Week 4|Percentage change from Baseline at Week 4 = (Week 4 value - Day 0 value)/(Day 0 value) x 100. Note: MRS consists of 11 symptoms, where each symptom is assigned a score from 0 to 4 (0 = 'None' and 4 = 'Extremely severe').|4 weeks from Baseline (Day 0)|The analysis population consists of all randomized patients who received at least 1 dose of randomized study drug starting at visit 3, who had at least 1 post-dose efficacy assessment. Missing efficacy data were not imputed.||Percentage Change||95% Confidence Interval|Mean
800037|NCT00962585|Post-Hoc|Change From Baseline in Menopause Rating Scale (MRS) - Sum of 3 Symptoms (Irritability, Dry Vagina, Joint/Muscular Discomfort) - S-equol Groups Combined|"The following analysis shows the results when the S-equol groups (S-equol 20 mg total daily dose, 100 mg total daily dose, and 300 mg total daily dose) are combined and regarded as a single treatment group.
Note: Each MRS symptoms was assigned a score from 0 to 4 (0 = 'None' and 4 = 'Extremely severe'"|4 weeks from Baseline (Day 0)|||units on a scale||95% Confidence Interval|Mean
800038|NCT00962585|Post-Hoc|Percentage Change From Baseline in Menopause Rating Scale (MRS) - Sum of 3 Symptoms (Irritability, Dry Vagina, Joint/Muscular Discomfort)|Percentage change from Baseline at Week 4 = (Week 4 value - Day 0 value)/(Day 0 value) x 100. Note: Each MRS symptoms is assigned a score from 0 to 4 (0 = 'None' and 4 = 'Extremely severe').|4 weeks from Baseline (Day 0)|||Percentage Change||95% Confidence Interval|Mean
800039|NCT00962585|Post-Hoc|Change From Baseline in Menopause Rating Scale (MRS) - Sum of 3 Symptoms (Irritability, Dry Vagina, Joint/Muscular Discomfort)|"Note: Each MRS symptoms is assigned a score from 0 to 4 (0 = 'None' and 4 = 'Extremely severe').
Scores for Symptoms 5, 10, and 11 on the MRS were summed and analyzed. Total summed scores ranged from 0 to 12, with higher scores representing more severe symptoms."|4 weeks from Baseline (Day 0)|||units on a scale||95% Confidence Interval|Mean
800040|NCT00962585|Secondary|Mean Change in the Menopause Rating Scale Total Score From Baseline at Week 4|"MRS consists of 11 menopause symptoms. The scoring scheme is simple, i.e., the score increases point by point with increasing severity of subjectively perceived symptoms in each of the 11 items (severity 0 [no complaints] 4 scoring points [extremely severe symptoms]). The respondent provides her personal perception by checking one of 5 possible boxes of severity for each of the items. The composite score (total score) is the sum of the 11 item scores, which can range from 0 (no symptoms) to 44 (extremely severe symptoms). Low total scores represent less severe menopause symptoms while higher scores represent more severe symptoms."|4 weeks from Baseline (Day 0)|The analysis population consists of all randomized patients who received at least 1 dose of randomized study drug starting at visit 3, who had at least 1 post-dose efficacy assessment. Missing efficacy data were not imputed.||units on a scale||95% Confidence Interval|Mean
800041|NCT00962585|Secondary|Change From Baseline in Progesterone Concentration at Week 2 and Week 4|No repeated measures ANCOVA results are presented for change from Baseline in progesterone concentrations since the model did not converge.|2 and 4 weeks from Baseline (Day 0)|The analysis population consists of all randomized patients who received at least 1 dose of randomized study drug starting at visit 3, who had at least 1 post-dose efficacy assessment. Missing efficacy data were not imputed.||Progesterone Concentration (nmol/L)||95% Confidence Interval|Mean
800042|NCT00962585|Secondary|Change From Baseline in Estradiol Concentration at Weeks 2 and 4|The LSMeans refer to overall adjusted mean estradiol concentration.|2 and 4 weeks from Baseline (Day 0)|The analysis population consists of all randomized patients who received at least 1 dose of randomized study drug starting at visit 3, who had at least 1 post-dose efficacy assessment. Missing efficacy data were not imputed.||Estradiol Concentration (pmol/L)||95% Confidence Interval|Mean
800043|NCT00962585|Secondary|Change From Baseline in Vaginal Maturation Index at Week 2 and Week 4|"The Vaginal Maturation Index was calculated by examining the maturation of the vaginal epithelium as adjudged by the cell types exfoliated. Parabasal cells are the least mature cells, intermediate cells display mild maturation, and superficial cells display the most maturity. The cell count is expressed as a percentage. The Vaginal Maturation Index was calculated as: 0.2*(parabasal cells, %)+0.6*(intermediate cells, %)+1.0*(superficial cells, %). This method is described in Menopause 2005;12(6):708-15.
The index serves as an objective means of evaluating hormonal secretion or response; lower values indicate more immature cells on the surface (atrophy), while higher values indicate more mature epithelium.
The LSMeans refer to overall adjusted mean percent of cells counted."|2 and 4 weeks from Baseline (Day 0)|The analysis population consists of all randomized patients who received at least 1 dose of randomized study drug starting at visit 3, who had at least 1 post-dose efficacy assessment. Missing efficacy data were not imputed.||percentage of cells||95% Confidence Interval|Mean
800044|NCT00962585|Secondary|Change From Baseline (Day 0) in Vaginal pH at Week 2 and Week 4|"The pH scale measures how acidic or basic a substance is. The pH scale ranges from 0 to 14. A pH of 7 is neutral. A pH less than 7 is acidic. A pH greater than 7 is basic. The pH scale is logarithmic and as a result, each whole pH value below 7 is ten times more acidic than the next higher value.
Normal vaginal pH is 3.8 to 4.5, slightly acidic.
The LSMeans refer to overall adjusted mean pH."|2 and 4 weeks from Baseline (Day 0)|The analysis population consists of all randomized patients who received at least 1 dose of randomized study drug starting at visit 3, who had at least 1 post-dose efficacy assessment. Missing efficacy data were not imputed.||units on a scale||95% Confidence Interval|Mean
800045|NCT00962585|Secondary|Change From Baseline (Day 0) in the Severity of VMS as Recorded in the Patient Diary at Week 1, Week 2, and Week 4|"The severity of vasomotor symptoms per week at each of the protocol visits was calculated for each patient as follows: [(Sum of scores of Mild, Moderate, Severe hot flushes)/(Current protocol visit date – Previous protocol visit date (days)] * 7, where severity of vasomotor symptoms were scored as: 1 = mild, 2 = moderate and 3 = severe. Higher values represented worse severity.
LSMeans refer to the overall adjusted mean severity of VMS.
Hot Flush Classification: Mild: sensation of heat without sweating; Moderate: sensation of heat with sweating, able to continue activity; Severe: sensation of heat with sweating, causing cessation of activity.
Patients recorded the number of hot flushes (day and night) in their diaries related to the severity (mild/moderate/severe)."|1, 2, and 4 weeks from Baseline (Day 0)|The analysis population consists of all randomized patients who received at least 1 dose of randomized study drug starting at visit 3, who had at least 1 post-dose efficacy assessment. Missing efficacy data were not imputed.||units on a scale||95% Confidence Interval|Mean
802960|NCT00988442|Secondary|Quality of Life Measured by Euro-QoL - Anxiety/Depression|Quality of Life Measured by Euro-QoL - Question 5: Anxiety/Depression.|Week 24|Available data from participants who made it to week 24 are summarized.||Participants|||Count of Participants
800046|NCT00962585|Secondary|Change From Baseline (Day 0) in the Frequency of MSVS at Week 1 and Week 2|"The frequency of MSVS per week, at each of the protocol visits, was calculated as follows, for each patient: [# of Moderate+Severe hot flushes)/(Current protocol visit date–Previous protocol visit date (days)] * 7.
The ANCOVA procedure tested the following hypotheses:
H0: μ1 = μp versus HA: μ1 ≠ μp, where μ1 and μp denote the mean frequency of MSVS, adjusted for Baseline MSVS values, in the treatment and placebo groups, respectively.
LSMeans refer to the overall adjusted mean frequecy of MSVS."|1 and 2 weeks from Baseline (Day 0)|The analysis population consists of all randomized patients who received at least 1 dose of randomized study drug starting at visit 3, who had at least 1 post-dose efficacy assessment. Missing efficacy data were not imputed.||Number of MSVS/week||95% Confidence Interval|Mean
800047|NCT00962585|Secondary|Mean Change in Frequency of MSVS From Baseline at Week 4 (1-week Period)|"Change from Baseline in the frequency of MSVS (difference between Baseline [period following first 7 days of 2-week run-in period] and period following first 7 days of 2-week Week 4 period), where the Baseline MSVS frequency was captured at visit 3 (Day 0), in the period following the first 7 days, as per CRF. Note: this endpoint is identical to the primary endpoint, however, instead of a 14 ± 2 day period, the period following the first 7 days was used, at Baseline and visit 3.
Treatment group differences are estimated using least squares (LS) means and 95% confidence intervals based on the mean square error from the ANCOVA. LSMeans refer to overall adjusted mean frequency of MSVS."|4 weeks from Baseline (period following first 7 days of 2-week run-in period)|The analysis population consists of all randomized patients who received at least 1 dose of randomized study drug starting at visit 3, who had at least 1 post-dose efficacy assessment. Missing efficacy data were not imputed.||Number of MSVS/week||95% Confidence Interval|Mean
800048|NCT00962585|Primary|Mean Change in Frequency of Moderate to Severe Vasomotor Symptoms (MSVS) Baseline at Week 4 (2-week Period)|"The primary efficacy endpoint for this study was the change from Baseline (Day 0) in the frequency of MSVS (difference between Baseline [2-week run-in period] and Week 4), where the baseline MSVS frequency was captured over 14 ± 2 day period. Moderate is defined as “sensation of heat with sweating, able to continue activity”; severe is defined as “sensation of heat with sweating, causing cessation of activity”. Patients used the take-home daily diary to record MSVS information during the run-in period and treatment period and analyses were performed as specified.
Treatment group differences are estimated using least squares (LS) means and 95% confidence intervals based on the mean square error from the ANCOVA. LSMeans refer to overall adjusted mean frequency of MSVS."|4 weeks from Baseline (2-week run-in period)|The analysis population consists of all randomized patients who received at least 1 dose of randomized study drug starting at visit 3, who had at least 1 post-dose efficacy assessment. Missing efficacy data were not imputed.||Number of MSVS/2 weeks||95% Confidence Interval|Mean
800049|NCT00962598|Secondary|Clinician's Global Improvement Scale (CGI)|a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.|baseline and 10-week treatment phase|3 participants in Omega-3 Fatty Acids arm were discontinued prior to receiving treatment and were not included in the data results||units on a scale||Standard Deviation|Mean
800050|NCT00962598|Primary|Children's Depressive Rating Scale - Revised (CDRS-R)|It is a 17-item scale, with items ranging from 1 to 5 or 1 to 7 (possible total score from 17 to 113), rated by a clinician via interviews with the child and parent. A score of ≥40 is indicative of depression, whereas a score ≤28 is often used to define remission (minimal or no symptoms).|baseline and 10-weeks|3 participants in Omega-3 Fatty Acids arm were discontinued prior to receiving treatment and were not included in the data results||units on a scale||Standard Deviation|Mean
800051|NCT00962650|Primary|Completion of Diagnostic Peritineoscopy|"Number of participants in which transgastric access was achieved using the EES NOTES GEN1 Toolbox
Outcome description: Completion of diagnostic peritoneoscopy after transgastric access was completed using a flexible, steerable trocar. Because this was a feasibility trial, transgastric access was the primary outcome."|Assessed intra-operatively as the time from first insertion of the flexible trocar into the oral cavity to final withdrawal of the flexible trocar|The subject pool was limited to individuals scheduled for Rouen Y gastric bypass(Intent to Treat population). There was no statistical analysis. Success was based on completion of the diagnostic peritineoscopy procedure after transgastric access.||Participants|||Number
800052|NCT00962741|Other Pre-specified|Number of Participants With Neutralizing Anti-etanercept Antibodies||Baseline up to Week 12, Week 48, Week 96|Safety population included all participants who received at least 1 dose of the study medication.||Participants|||Number
800053|NCT00962741|Other Pre-specified|Number of Participants With Anti-etanercept Antibodies: PsA Sub-population||Baseline up to Week 12, Week 48, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a firstdegree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Participants|||Number
800054|NCT00962741|Other Pre-specified|Number of Participants With Anti-etanercept Antibodies: ERA Sub-population||Baseline up to Week 12, Week 48, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Participants|||Number
800055|NCT00962741|Other Pre-specified|Number of Participants With Anti-etanercept Antibodies: eoJIA Sub-population||Baseline up to Week 12, Week 48, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Participants|||Number
800056|NCT00962741|Other Pre-specified|Number of Participants With Anti-etanercept Antibodies||Baseline up to Week 12, Week 48, Week 96|Safety population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Participants|||Number
800328|NCT00955474|Secondary|Blood Level of Triglycerides at Baseline and Week 8.|Level of triglycerides at Baseline and Week 8. Normal range: 40-150mg/dl.|8 weeks|Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.||mg/dl||Standard Deviation|Mean
800057|NCT00962741|Other Pre-specified|Body Mass Index (BMI) z-Score by Age Group for PsA Sub-population|BMI was used to measure body fat based on height and weight. It was calculated by body weight (kg)/height (m) squared. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.|Baseline, Week 12, Week 48, Week 72, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||z-score||Standard Deviation|Mean
800058|NCT00962741|Other Pre-specified|Body Mass Index (BMI) z-Score by Age Group for ERA Sub-population|BMI was used to measure body fat based on height and weight. It was calculated by body weight (kg)/height (m) squared. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.|Baseline, Week 12, Week 48, Week 72, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||z-score||Standard Deviation|Mean
800059|NCT00962741|Other Pre-specified|Body Mass Index (BMI) z-Score by Age Group for eoJIA Sub-population|BMI was used to measure body fat based on height and weight. It was calculated by body weight (kg)/height (m) squared. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.|Baseline, Week 12, Week 48, Week 72, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease and had progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||z-score||Standard Deviation|Mean
800060|NCT00962741|Other Pre-specified|Body Mass Index (BMI) z-Score by Age Group|BMI was used to measure body fat based on height and weight. It was calculated by body weight (kg)/height (m) squared. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.|Baseline, Week 12, Week 48, Week 72, Week 96|Safety population: participants who received at least 1 dose of study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||z-score||Standard Deviation|Mean
800061|NCT00962741|Other Pre-specified|Weight z-Scores by Age Group for PsA Sub-population|Weight was taken as a mean of 3 consecutive measurements using a medical electronic scale. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||z-score||Standard Deviation|Mean
800062|NCT00962741|Other Pre-specified|Weight z-Scores by Age Group for ERA Sub-population|Weight was taken as a mean of 3 consecutive measurements using a medical electronic scale. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||z-score||Standard Deviation|Mean
800063|NCT00962741|Other Pre-specified|Weight z-Scores by Age Group for eoJIA Sub-population|Weight was taken as a mean of 3 consecutive measurements using a medical electronic scale. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease and had progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||z-score||Standard Deviation|Mean
800064|NCT00962741|Other Pre-specified|Weight z-Scores by Age Group|Weight was taken as a mean of 3 consecutive measurements using a medical electronic scale. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|Safety population: participants who received at least 1 dose of study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||z-score||Standard Deviation|Mean
800341|NCT00955487|Secondary|Sepsis|Number of participants that developed sepsis|Randomization to discharge|||Participants|||Count of Participants
800065|NCT00962741|Other Pre-specified|Height z-Score by Age Group for PsA Sub-population|Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.|Baseline, Week 12, Week 48, Week 72, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||z-score||Standard Deviation|Mean
800066|NCT00962741|Other Pre-specified|Height z-Score by Age Group for ERA Sub-population|Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.|Baseline, Week 12, Week 48, Week 72, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||z-score||Standard Deviation|Mean
800067|NCT00962741|Other Pre-specified|Height z-Score by Age Group for eoJIA Sub-population|Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.|Baseline, Week 12, Week 48, Week 72, Week 96|eoJIA sub-population: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease and had progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||z-score||Standard Deviation|Mean
800068|NCT00962741|Other Pre-specified|Height z-Score by Age Group|Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.|Baseline, Week 12, Week 48, Week 72, Week 96|Safety population: participants who received at least 1 dose of study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||z-score||Standard Deviation|Mean
800069|NCT00962741|Other Pre-specified|Tanner Assessment Score by Age Group for PsA Sub-population|Tanner assessment score: used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size).|Baseline, Week 12, Week 48, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Units on a scale||Standard Deviation|Mean
800070|NCT00962741|Other Pre-specified|Tanner Assessment Score by Age Group for ERA Sub-population|Tanner assessment score: used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size).|Baseline, Week 12, Week 48, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Units on a scale||Standard Deviation|Mean
800071|NCT00962741|Other Pre-specified|Tanner Assessment Score by Age Group for eoJIA Sub-population|Tanner assessment score: used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size).|Baseline, Week 12, Week 48, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Units on a scale||Standard Deviation|Mean
800072|NCT00962741|Other Pre-specified|Tanner Assessment Score by Age Group|Tanner assessment score: used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size).|Baseline, Week 12, Week 48, Week 96|Safety population: participants who received at least 1 dose of study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Units on a scale||Standard Deviation|Mean
800073|NCT00962741|Other Pre-specified|Number of Participants With Adverse Events (AEs): PsA Sub-population|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Number of participants reporting adverse events included medically important infections, infections considered preventable by vaccination, injection site reactions (ISRS), malignancies, adverse events, excluding infections and injection site reactions, infections and serious adverse events including infections.|Week 12, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Participants|||Number
800074|NCT00962741|Other Pre-specified|Number of Participants With Adverse Events (AEs): ERA Sub-population|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Number of participants reporting adverse events included medically important infections, infections considered preventable by vaccination, injection site reactions (ISRS), malignancies, adverse events, excluding infections and injection site reactions, infections and serious adverse events including infections.|Week 12, Week 96|ERA:participants with Ar/enthesitis, any 2: sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis, ERA, sacroiliitis with Ifm bowel disease, Reiter’s syndrome history; human leukocyte antigen-B27;Ar in male>6yrs; AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Participants|||Number
800075|NCT00962741|Other Pre-specified|Number of Participants With Adverse Events (AEs): eoJIA Subpopulation|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Number of participants reporting adverse events included medically important infections, infections considered preventable by vaccination, injection site reactions (ISRS), malignancies, adverse events, excluding infections and injection site reactions, infections and serious adverse events including infections.|Week 12, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Participants|||Number
800076|NCT00962741|Other Pre-specified|Number of Participants With Adverse Events (AEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Number of participants reporting adverse events included medically important infections, infections considered preventable by vaccination, injection site reactions (ISRS), malignancies, adverse events, excluding infections and injection site reactions, infections and serious adverse events including infections.|Week 12, Week 96|Safety population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Participants|||Number
800077|NCT00962741|Other Pre-specified|Physician's Global Assessment (PGA) of Psoriasis for PsA Sub-population|PGA of Psoriasis assessed the amount of induration, erythema, and scaling averaged over all psoriatic lesions on a scale of 0 to 5. 0 (no psoriasis) to 5 (severe disease). ‘Clear’ and “Almost clear’ includes all participants who were scored as a 0 or 1.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Units on a scale||Standard Deviation|Mean
800078|NCT00962741|Other Pre-specified|Percentage of Body Surface Area (BSA) Affected by Psoriasis for PsA Sub-population|Percentage of body surface area affected by psoriasis was estimated using the palm method: one of the participant’s palm to proximal interphalangeal and thumb= 1 percent (%) of BSA. Regions of the body were assigned specific number of palms with percentage [Head and neck= 10% (10 palms), upper extremities= 20% (20 palms), Trunk (axillae and groin)= 30% (30 palms), lower extremities (buttocks)= 40% (40 palms)]. The total BSA affected was the summation of individual regions affected.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Percentage of BSA||Standard Deviation|Mean
800079|NCT00962741|Other Pre-specified|Modified Schober's Test for ERA Sub-population|Modified Schober’s Test: A mark was placed in the midpoint of a line that joined the posterior superior iliac spines. Another mark was placed 10 centimeter (cm) above the first. The participant then bent maximally forward with the knees fully extended. The distance between the two marks was then re-measured. The full measurement between the two lines was recorded to the nearest tenth of a centimeter.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||cm||Standard Deviation|Mean
800080|NCT00962741|Other Pre-specified|Nocturnal Back Pain Score for ERA Sub-population|Nocturnal back pain assessed by participant’s parent using a 100 mm VAS with 0 mm = no pain and 100 mm = most severe pain.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||mm||Standard Deviation|Mean
800081|NCT00962741|Other Pre-specified|Overall Back Pain Score for ERA Sub-population|Overall back pain assessed by participant’s parent using a 100 millimeter (mm) VAS with 0 mm= no pain and 100 mm= most severe pain.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||mm||Standard Deviation|Mean
800082|NCT00962741|Other Pre-specified|Tender Entheseal Assessment for ERA Sub-population|Tender entheseal assessment: Entheses were assessed and coded as: 1= any tenderness, 0= no tenderness, NE= not evaluable. Total number of tender entheses: 66*(total number of tender entheses with counts > 0)/number of non-missing tender entheses. If > 33 tender entheseal counts were missing, total number of tender entheses was defined as missing.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Tender entheses||Standard Deviation|Mean
800342|NCT00955487|Secondary|Severe Intracranial Hemorrhage|Number of participants that developed severe intracranial hemorrhage (grade 3-4)|Randomization to discharge|||Participants|||Count of Participants
800083|NCT00962741|Secondary|Childhood Health Assessment Questionnaire (CHAQ) Score: PsA Sub-population|CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report participants’s ability to perform activities in 8 domains: dressing, arising, eating, walking,hygiene, each,grip,common activities distributed in total of 30 items.Each item is scored on 4-point Likert scale: 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Highest score reported for domain is score for that domain.Overall score = sum of domain scores divided by number of domains answered. Total score: 0=no difficulty to 3=extreme difficulty.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Units on a scale||Standard Deviation|Mean
800084|NCT00962741|Secondary|Childhood Health Assessment Questionnaire (CHAQ) Score: ERA Sub-population|CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report participants’s ability to perform activities in 8 domains: dressing, arising, eating, walking,hygiene, each,grip,common activities distributed in total of 30 items.Each item is scored on 4-point Likert scale: 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Highest score reported for domain is score for that domain.Overall score = sum of domain scores divided by number of domains answered. Total score: 0=no difficulty to 3=extreme difficulty.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA: participants with Ar /enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Units on a scale||Standard Deviation|Mean
800085|NCT00962741|Secondary|Childhood Health Assessment Questionnaire (CHAQ) Score: eoJIA Sub-population|CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report participants’s ability to perform activities in 8 domains: dressing, arising, eating, walking,hygiene, each,grip,common activities distributed in total of 30 items.Each item is scored on 4-point Likert scale: 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Highest score reported for domain is score for that domain.Overall score = sum of domain scores divided by number of domains answered. Total score: 0=no difficulty to 3=extreme difficulty.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Units on a scale||Standard Deviation|Mean
800086|NCT00962741|Secondary|Childhood Health Assessment Questionnaire (CHAQ) Score|CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report participants’s ability to perform activities in 8 domains: dressing, arising, eating, walking,hygiene, each,grip,common activities distributed in total of 30 items.Each item is scored on 4-point Likert scale: 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Highest score reported for domain is score for that domain.Overall score = sum of domain scores divided by number of domains answered. Total score: 0=no difficulty to 3=extreme difficulty.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Units on a scale||Standard Deviation|Mean
800087|NCT00962741|Secondary|Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: PsA Sub-population|Inactive disease was defined as no joints with active arthritis, a normal CRP, and a PGA of Disease Activity of 0 on a 21-circle VAS.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Percentage of participants|||Number
800088|NCT00962741|Secondary|Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: ERA Sub-population|Inactive disease was defined as no joints with active arthritis, a normal CRP, and a PGA of Disease Activity of 0 on a 21-circle VAS.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA:participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history;ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter's syndrome history;humanleukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Percentage of participants|||Number
800089|NCT00962741|Secondary|Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: eoJIA Sub-population|Inactive disease was defined as no joints with active arthritis, a normal CRP, and a PGA of Disease Activity of 0 on a 21-circle VAS.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease and had progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Percentage of participants|||Number
800090|NCT00962741|Secondary|Percentage of Participants With Inactive Disease Per Wallace 2004 Definition|Inactive disease was defined as no joints with active arthritis, a normal CRP, and a PGA of Disease Activity of 0 on a 21-circle VAS.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Percentage of participants|||Number
800101|NCT00962741|Secondary|C-reactive Protein (CRP): eoJIA Sub-population|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||mg/L||Standard Deviation|Mean
800343|NCT00955487|Secondary|Threshold Retinopathy of Prematurity (ROP)|Threshold ROP defined as requiring interventional therapy|Randomization to discharge|||Participants|||Count of Participants
800091|NCT00962741|Secondary|Duration of Morning Stiffness: PsA Sub-population|Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes was recorded).|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Minutes||Standard Deviation|Mean
800092|NCT00962741|Secondary|Duration of Morning Stiffness: ERA Sub-population|Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes was recorded).|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Minutes||Standard Deviation|Mean
800093|NCT00962741|Secondary|Duration of Morning Stiffness: eoJIA Sub-population|Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes was recorded).|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Minutes||Standard Deviation|Mean
800094|NCT00962741|Secondary|Duration of Morning Stiffness|Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes was recorded).|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Minutes||Standard Deviation|Mean
800095|NCT00962741|Secondary|Pain Assessment: PsA Sub-population|Pain Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = no pain and 10 = very severe pain.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Units on a scale||Standard Deviation|Mean
800096|NCT00962741|Secondary|Pain Assessment: ERA Sub-population|Pain Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = no pain and 10 = very severe pain.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Units on a scale||Standard Deviation|Mean
800097|NCT00962741|Secondary|Pain Assessment: eoJIA Sub-population|Pain Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = no pain and 10 = very severe pain.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Units on a scale||Standard Deviation|Mean
800098|NCT00962741|Secondary|Pain Assessment|Pain Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = no pain and 10 = very severe pain.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Units on a scale||Standard Deviation|Mean
800099|NCT00962741|Secondary|C-reactive Protein (CRP): PsA Sub-population|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||mg/L||Standard Deviation|Mean
800100|NCT00962741|Secondary|C-reactive Protein (CRP): ERA Sub-population|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||mg/L||Standard Deviation|Mean
800344|NCT00955487|Secondary|Symptomatic PDA Requiring Surgical Ligation|Number of participants with symptomatic PDA that required surgical ligation|Randomization through discharge|||Participants|||Count of Participants
800103|NCT00962741|Secondary|Number of Joints With Limitation of Motion: PsA Sub-population|The joints were assessed and coded as: 0= no limitation of motion; 1= any limitation of motion; JR= joint replacement; NE= not evaluable. Total number of joints with limitation of motion: 69*(total number of joints with counts of limitation of motion > 0)/number of non-missing limitation of motions. JR and NE were treated as missing. If > 34 counts of limitation of motion were missing, total number of joints with limitation of motion was defined as missing.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Joints||Standard Deviation|Mean
800104|NCT00962741|Secondary|Number of Joints With Limitation of Motion: ERA Sub-population|The joints were assessed and coded as: 0= no limitation of motion; 1= any limitation of motion; JR= joint replacement; NE= not evaluable. Total number of joints with limitation of motion: 69*(total number of joints with counts of limitation of motion > 0)/number of non-missing limitation of motions. JR and NE were treated as missing. If > 34 counts of limitation of motion were missing, total number of joints with limitation of motion was defined as missing.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Joints||Standard Deviation|Mean
800105|NCT00962741|Secondary|Number of Joints With Limitation of Motion: eoJIA Sub-population|The joints were assessed and coded as: 0= no limitation of motion; 1= any limitation of motion; JR= joint replacement; NE= not evaluable. Total number of joints with limitation of motion: 69*(total number of joints with counts of limitation of motion > 0)/number of non-missing limitation of motions. JR and NE were treated as missing. If > 34 counts of limitation of motion were missing, total number of joints with limitation of motion was defined as missing.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Joints||Standard Deviation|Mean
800106|NCT00962741|Secondary|Number of Joints With Limitation of Motion|The joints were assessed and coded as: 0= no limitation of motion; 1= any limitation of motion; JR= joint replacement; NE= not evaluable. Total number of joints with limitation of motion: 69*(total number of joints with counts of limitation of motion > 0)/number of non-missing limitation of motions. JR and NE were treated as missing. If > 34 counts of limitation of motion were missing, total number of joints with limitation of motion was defined as missing.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Joints||Standard Deviation|Mean
800107|NCT00962741|Secondary|Number of Active Joints: PsA Sub-population|Active joints: Joints that were swollen or, in absence of swelling, joints with limited motion with pain and/or tenderness. Joints were coded as: 0= no swelling, limitation of motion, or pain and/or tenderness on motion; 1= any swelling, limitation of motion, or pain and/or tenderness on motion; JR= joint replacement; NE= not evaluable. Total number of active joints= 73*(total number of active joints with counts > 0)/number of non-missing active joints. JR and NE were treated as missing. If > 36 active joint counts were missing, total number of active joints was defined as missing.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Joints||Standard Deviation|Mean
800108|NCT00962741|Secondary|Number of Active Joints: ERA Sub-population|Active joints: Joints that were swollen or, in absence of swelling, joints with limited motion with pain and/or tenderness. Joints were coded as: 0= no swelling, limitation of motion, or pain and/or tenderness on motion; 1= any swelling, limitation of motion, or pain and/or tenderness on motion; JR= joint replacement; NE= not evaluable. Total number of active joints= 73*(total number of active joints with counts > 0)/number of non-missing active joints. JR and NE were treated as missing. If > 36 active joint counts were missing, total number of active joints was defined as missing.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Joints||Standard Deviation|Mean
800109|NCT00962741|Secondary|Number of Active Joints: eoJIA Sub-population|Active joints: Joints that were swollen or, in absence of swelling, joints with limited motion with pain and/or tenderness. Joints were coded as: 0= no swelling, limitation of motion, or pain and/or tenderness on motion; 1= any swelling, limitation of motion, or pain and/or tenderness on motion; JR= joint replacement; NE= not evaluable. Total number of active joints= 73*(total number of active joints with counts > 0)/number of non-missing active joints. JR and NE were treated as missing. If > 36 active joint counts were missing, total number of active joints was defined as missing.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Joints||Standard Deviation|Mean
800164|NCT00962871|Primary|Mean Change From Baseline in Viral Quantitative e Antibody|An acute virologic response was determined by change from baseline in viral antigen/antibody laboratory data.|Day 1, 3, 5, 8, 10, 14, Week 3, 4, 5, 6 (weeks are computed from the first dose of Pegasys)|All participants who received at least 1 dose of the study medication were included in this analysis. Only participants with both a baseline value and a value particular time point were summarized.||Cut-off index (C.O.I.)||Standard Deviation|Mean
800345|NCT00955487|Secondary|Symptomatic PDA Requiring Medical Treatment|Number of participants with a symptomatic PDA that required medical treatment|From randomization until discharge|||Participants|||Count of Participants
800110|NCT00962741|Secondary|Number of Active Joints|Active joints: Joints that were swollen or, in absence of swelling, joints with limited motion with pain and/or tenderness. Joints were coded as: 0= no swelling, limitation of motion, or pain and/or tenderness on motion; 1= any swelling, limitation of motion, or pain and/or tenderness on motion; JR= joint replacement; NE= not evaluable. Total number of active joints= 73*(total number of active joints with counts > 0)/number of non-missing active joints. JR and NE were treated as missing. If > 36 active joint counts were missing, total number of active joints was defined as missing.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Joints||Standard Deviation|Mean
800111|NCT00962741|Secondary|Patient/Parent Global Assessment: PsA Sub-population|Patient/Parent Global Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = very well and 10 = very poor.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Units on a scale||Standard Deviation|Mean
800112|NCT00962741|Secondary|Patient/Parent Global Assessment: ERA Sub-population|Patient/Parent Global Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = very well and 10 = very poor.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Units on a scale||Standard Deviation|Mean
800113|NCT00962741|Secondary|Patient/Parent Global Assessment: eoJIA Sub-population|Patient/Parent Global Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = very well and 10 = very poor.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Units on a scale||Standard Deviation|Mean
800114|NCT00962741|Secondary|Patient/Parent Global Assessment|Patient/Parent Global Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = very well and 10 = very poor.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Units on a scale||Standard Deviation|Mean
800115|NCT00962741|Secondary|Physician's Global Assessment (PGA) of Disease Activity: PsA Sub-population|PGA of Disease Activity was measured on a 21-circle Visual Analog Scale (VAS) ranging from 0 to 10, with 0 = no disease activity and 10= Maximum disease activity.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Units on a scale||Standard Deviation|Mean
800116|NCT00962741|Secondary|Physician's Global Assessment (PGA) of Disease Activity: ERA Sub-population|PGA of Disease Activity was measured on a 21-circle Visual Analog Scale (VAS) ranging from 0 to 10, with 0 = no disease activity and 10= Maximum disease activity.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Units on a scale||Standard Deviation|Mean
800117|NCT00962741|Secondary|Physician's Global Assessment (PGA) of Disease Activity: eoJIA Sub-population|PGA of Disease Activity was measured on a 21-circle Visual Analog Scale (VAS) ranging from 0 to 10, with 0 = no disease activity and 10= Maximum disease activity.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Units on a scale||Standard Deviation|Mean
800118|NCT00962741|Secondary|Physician's Global Assessment (PGA) of Disease Activity|PGA of Disease Activity was measured on a 21-circle Visual Analog Scale (VAS) ranging from 0 to 10, with 0 = no disease activity and 10= Maximum disease activity.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Units on a scale||Standard Deviation|Mean
800119|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 100 Response: PsA Sub-population|ACR Pedi 100 response: 100% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Percentage of participants||95% Confidence Interval|Number
800252|NCT00963599|Secondary|Mean Change From Baseline in Daytime Eye Symptoms Score|Mean change from baseline in Daytime Eye Symptoms scores. Patients were asked to rate each of the 4 eye symptom of tearing, itchy, red, and puffy eyes daily on a 4-point scale (0 (best) to 3 (worst)). The average of the 4 individual eye symptoms scores was reported as the Daytime Eye Symptoms Score.|Baseline and Week 2|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.||Units on a Scale||95% Confidence Interval|Least Squares Mean
800120|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 100 Response: ERA Sub-population|ACR Pedi 100 response: 100% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Percentage of participants||95% Confidence Interval|Number
800121|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 100 Response: eoJIA Sub-population|ACR Pedi 100 response: 100% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease and had progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Percentage of participants||95% Confidence Interval|Number
800122|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 100 Response|ACR Pedi 100 response: 100% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Percentage of participants||95% Confidence Interval|Number
800123|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 90 Response: PsA Sub-population|ACR Pedi 90 response: >= 90% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Percentage of participants||95% Confidence Interval|Number
800124|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 90 Response: ERA Sub-population|ACR Pedi 90 response: >= 90% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Percentage of participants||95% Confidence Interval|Number
800125|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 90 Response:eoJIA Sub-population|ACR Pedi 90 response: >= 90% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease and had progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Percentage of participants||95% Confidence Interval|Number
800126|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 90 Response|ACR Pedi 90 response: >= 90% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Percentage of participants||95% Confidence Interval|Number
800127|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 70 Response: PsA Sub-population|ACR Pedi 70 response: >= 70% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Percentage of participants||95% Confidence Interval|Number
800192|NCT00963157|Primary|Number of Participants With Chemistry Laboratory Adverse Events After the First Vaccination|Blood was drawn 8-10 days after vaccination to assess laboratory parameters at a central laboratory. Adverse events (AE) were any values that were Grade 1 or greater for the following parameters: sodium (AE >146 or <135 mEq/L), potassium (>5.3 or <3.5 mEq/L), creatinine (>1.4 mg/dL), Alanine transaminase (>52.7 U/L), Albumin (<3.2 g/dL), and total protein (<6.0 g/dL participants age 18-64 years, <5.8 g/dL participants age 65 years and older). These parameters were not evaluated prior to enrollment as an assessment of eligibility.|8-10 days after first vaccination|Participants who received the first vaccination and had blood collected with results reported at the timepoint are included. Analyses are as treated.||Participants|||Number
800128|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 70 Response: ERA Sub-population|ACR Pedi 70 response: >= 70% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Percentage of participants||95% Confidence Interval|Number
800129|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 70 Response: eoJIA Sub-population|ACR Pedi 70 response: >= 70% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease and had progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Percentage of participants||95% Confidence Interval|Number
800130|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 70 Response|ACR Pedi 70 response: >= 70% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Percentage of participants||95% Confidence Interval|Number
800131|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 50 Response: PsA Sub-population|ACR Pedi 50 response: >= 50% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Percentage of participants||95% Confidence Interval|Number
800132|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 50 Response: ERA Sub-population|ACR Pedi 50 response: >= 50% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Percentage of participants||95% Confidence Interval|Number
800133|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 50 Response: eoJIA Sub-population|ACR Pedi 50 response: >= 50% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease and had progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Percentage of participants||95% Confidence Interval|Number
800134|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 50 Response|ACR Pedi 50 response: >= 50% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Percentage of participants||95% Confidence Interval|Number
800135|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 30 Response: Psoriatic Arthritis (PsA) Sub-population|ACR Pedi 30 response: >= 30% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of arthritis pain, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Percentage of participants||95% Confidence Interval|Number
800223|NCT00963430|Primary|Number of Participants Reporting Solicited Subjective Systemic Reactions After Second Vaccination|Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Within 8 days (Day 0-7) post second vaccination|All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated.||Participants|||Number
811705|NCT01059760|Primary|Change From Baseline in Participant Red Cell Distribution Width (RDW) When Fasting and Fed||Baseline and 3 days|||% of SD of MCV to mean MCV||Standard Deviation|Mean
800136|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 30 Response: Enthesitis-Related Arthritis (ERA) Sub-population|ACR Pedi 30 response: >= 30% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of arthritis pain, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA:participants with arthritis(Ar) or(/)enthesitis,any 2:sacroiliac joint tenderness/inflammatory(Ifm)lumbosacral pain history;ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;acute anterior uveitis(AAU)/AAU first-degree relative.||Percentage of participants||95% Confidence Interval|Number
800137|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 30 Response: Extended Oligoarticular Juvenile Idiopathic Arthritis (eoJIA) Sub-population|ACR Pedi 30 response: >= 30% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of arthritis pain, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease and had progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Percentage of participants||95% Confidence Interval|Number
800138|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 30 Response|ACR Pedi 30 response: >= 30% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of arthritis pain, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein.|Week 4, Week 8, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Percentage of participants||95% Confidence Interval|Number
800139|NCT00962741|Primary|Percentage of Participants With an American College of Rheumatology Pediatric 30 (ACR Pedi 30) Response at Week 12|ACR Pedi 30 response: greater than or equal to (>=) 30% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of arthritis pain, 3) childhood health assessment questionnaire (CHAQ) 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein.|Week 12|Modified Intent-to-Treat (mITT) population included all participants who received at least 1 dose of the study medication. Here ‘N’ (Number of participants analyzed) signified those participants who were evaluable for this measure at week 12.||Percentage of participants||95% Confidence Interval|Number
800140|NCT00962754|Secondary|Complications|notifications of complications|duration of admission|||participants|||Number
800141|NCT00962754|Secondary|Use of Diuretics|prescription of diuretic therapy|during days of admission|||participants|||Number
800142|NCT00962754|Primary|Duration of Admission at the Ward in Days|Duration of hospital stay in days or duration of admission at the pediatric ward in days|1-8 months|intention to treat analysis||number of days||Full Range|Median
800143|NCT00962780|Other Pre-specified|Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3|Specific systemic events (fever >=38 degrees Celsius[C], fatigue, headache, vomiting, diarrhea, muscle pain, joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any (symptom present); Mild (did not interfere with activity); Moderate (some interference with activity); Severe (prevented routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours); Moderate (>2 times in 24 hours); Severe (required intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hours); Moderate (4-5 loose stools 24 hours); Severe (>=6 loose stools in 24 hours). All reporting of fever >40 degrees C except 1 participant and all reporting of severe vomiting, after 13vPnC Dose 3, were confirmed as data entry errors.|Within 14 days after 13vPnC Dose 3|Safety population. Here “N” (number of participants analyzed) signifies participants with known values for any systemic event and “n” signifies participants with known values for specified systemic event. Participants may be represented in more than 1 category.||percentage of participants|||Number
800144|NCT00962780|Other Pre-specified|Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2|Specific systemic events (fever >=38 degrees Celsius[C], fatigue, headache, vomiting, diarrhea, muscle pain, joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any (symptom present); Mild (did not interfere with activity); Moderate (some interference with activity); Severe (prevented routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours); Moderate (>2 times in 24 hours); Severe (required intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hours); Moderate (4-5 loose stools 24 hours); Severe (>=6 loose stools in 24 hours). All reporting of fever >40 degrees C and all reporting of severe vomiting, after 13vPnC Dose 2, were confirmed as data entry errors.|Within 14 days after 13vPnC Dose 2|Safety population. Here “N” (number of participants analyzed) signifies participants with known values for any systemic event and “n” signifies participants with known values for specified systemic event. Participants may be represented in more than 1 category.||percentage of participants|||Number
800165|NCT00963157|Primary|Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the first vaccination|Participants who received the H1N1 vaccination and from whom blood was collected within 7 days of the window are included. One participant was excluded due to influenza-like illness. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
800145|NCT00962780|Other Pre-specified|Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1|Specific systemic events (fever >=38 degrees Celsius[C], fatigue, headache, vomiting, diarrhea, muscle pain, joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any (symptom present); Mild (did not interfere with activity); Moderate (some interference with activity); Severe (prevented routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours); Moderate (>2 times in 24 hours); Severe (required intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hours); Moderate (4-5 loose stools 24 hours); Severe (>=6 loose stools in 24 hours). All reporting of fever >40 degrees C except 2 participants and all reporting of severe vomiting, after 13vPnC Dose 1, were confirmed as data entry errors.|Within 14 days after 13vPnC Dose 1|Safety population. Here “N” (number of participants analyzed) signifies participants with known values for any systemic event and “n” signifies participants with known values for specified systemic event. Participants may be represented in more than 1 category.||percentage of participants|||Number
800146|NCT00962780|Other Pre-specified|Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3|Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as Any (redness present or swelling present); Mild (0.5 to 2.0 cm for participants aged 6 to <12 years and 2.5 to 5.0 cm for participants aged >12 years); Moderate (2.5 to 7.0 cm for participants aged 6 to <12 years and 5.1 to 10.0 cm for participants aged >12 years); Severe (>7 cm for participants aged 6 to <12 years and >10 cm for participants aged >12 years). Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity).|Within 14 days after 13vPnC Dose 3|Safety population. Here “N” (number of participants analyzed) signifies participants with known values for any local reaction and “n” signifies participants with known values for specified local reaction. Participants may be represented in more than 1 category.||percentage of participants|||Number
800147|NCT00962780|Other Pre-specified|Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2|Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as Any (redness present or swelling present); Mild (0.5 to 2.0 cm for participants aged 6 to <12 years and 2.5 to 5.0 cm for participants aged >12 years); Moderate (2.5 to 7.0 cm for participants aged 6 to <12 years and 5.1 to 10.0 cm for participants aged >12 years); Severe (>7 cm for participants aged 6 to <12 years and >10 cm for participants aged >12 years). Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity).|Within 14 days after 13vPnC Dose 2|Safety population. Here “N” (number of participants analyzed) signifies participants with known values for any local reaction and “n” signifies participants with known values for specified local reaction. Participants may be represented in more than 1 category.||percentage of participants|||Number
800148|NCT00962780|Other Pre-specified|Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1|Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as Any (redness present or swelling present); Mild (0.5 to 2.0 centimeters (cm) for participants aged 6 to <12 years and 2.5 to 5.0 cm for participants aged greater than (>) 12 years); Moderate (2.5 to 7.0 cm for participants aged 6 to <12 years and 5.1 to 10.0 cm for participants aged >12 years); Severe (>7 cm for participants aged 6 to <12 years and >10 cm for participants aged >12 years). Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity). Report of severe swelling was confirmed as data entry error.|Within 14 days after 13vPnC Dose 1|Safety population. Here “N” (number of participants analyzed) signifies participants with known values for any local reaction and “n” signifies participants with known values for specified local reaction. Participants may be represented in more than 1 category.||percentage of participants|||Number
800149|NCT00962780|Other Pre-specified|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 3 to 1 month after 23vPS Dose were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both 1 month after 13vPnC Dose 3 and 1 month after 23vPS Dose blood draws.|1 month after 13vPnC Dose 3, 1 month after 23vPS Dose|"Evaluable immunogenicity population. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies participants with valid and determinate assay results for specified serotype at both 1 month after 13vPnC Dose 3 and after 23vPS Dose blood draws for each treatment arm, respectively."||fold rise||95% Confidence Interval|Geometric Mean
800150|NCT00962780|Other Pre-specified|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants|Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of pediatric, adult and all participants using a mcOPA assay. GMT (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for both after 13vPnC Dose 3 and after 23vPS Dose blood draws. CI for GMT were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|1 month after 13vPnC Dose 3, 1 month after 23vPS Dose|"Evaluable immunogenicity population. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies participants with valid and determinate assay results for specified serotype at both 1 month after 13vPnC Dose 3 and after 23vPS Dose blood draws for each treatment arm, respectively."||titers||95% Confidence Interval|Geometric Mean
800286|NCT00954707|Secondary|Rate of Major Adverse Cardiac Events (MACE)|MACE includes Death, myocardial infarction, emergent bypass surgery, or target lesion revascularization at 12 months|12 Months|ITT Population patients with the specific event prior to end of follow-up plus patients without that event but with death or adequate follow-up (within 1 month prior to end of scheduled 12 months follow-up).||participants|||Number
800151|NCT00962780|Other Pre-specified|Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 3 to 1 month after 23vPS Dose were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both 1 month after 13vPnC Dose 3 and 1 month after 23vPS Dose blood draws.|1 month after 13vPnC Dose 3, 1 month after 23vPS Dose|"Evaluable immunogenicity population. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies participants with valid and determinate assay results for specified serotype at both 1 month after 13vPnC Dose 3 and after 23vPS Dose blood draws for each treatment arm, respectively."||fold rise||95% Confidence Interval|Geometric Mean
800152|NCT00962780|Other Pre-specified|Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants|Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for pediatric, adult and all participants are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for both after 13vPnC Dose 3 and after 23vPS Dose blood draws. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|1 month after 13vPnC Dose 3, 1 month after 23vPS Dose|"Evaluable immunogenicity population. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies participants with valid and determinate assay results for specified serotype at both 1 month after 13vPnC Dose 3 and after 23vPS Dose blood draws for each treatment arm, respectively."||mcg/mL||95% Confidence Interval|Geometric Mean
800153|NCT00962780|Other Pre-specified|Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC Dose 1 to 1 month after 13vPnC Dose 1 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both before 13vPnC Dose and after 13vPnC Dose 1 blood draws.|Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1|"Evaluable immunogenicity population. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies participants with valid and determinate assay results for specified serotype at both the before and 1 month after 13vPnC Dose 1 blood draws for each treatment arm, respectively."||fold rise||95% Confidence Interval|Geometric Mean
800154|NCT00962780|Other Pre-specified|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants|Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of pediatric, adult and all participants using a microcolony OPA (mcOPA) assay. GMT (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for both the before and after 13vPnC Dose 1 blood draws. CI for GMT were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1|"Evaluable immunogenicity population. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies participants with valid and determinate assay results for specified serotype at both the before and 1 month after 13vPnC Dose 1 blood draws for each treatment arm, respectively."||titers||95% Confidence Interval|Geometric Mean
800155|NCT00962780|Other Pre-specified|Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC Dose 1 to 1 month after 13vPnC Dose 1 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both before 13vPnC Dose and after 13vPnC Dose 1 blood draws.|Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1|"Evaluable immunogenicity population. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies participants with valid and determinate assay results for specified serotype at both the before and 1 month after 13vPnC Dose 1 blood draws for each treatment arm, respectively."||fold rise||95% Confidence Interval|Geometric Mean
800156|NCT00962780|Other Pre-specified|Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants|Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for pediatric, adult and all participants are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for both the before and after 13vPnC Dose 1 blood draws. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1|"Evaluable immunogenicity population. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies participants with valid and determinate assay results for specified serotype at both the before and 1 month after 13vPnC Dose 1 blood draws for each treatment arm, respectively."||mcg/mL||95% Confidence Interval|Geometric Mean
800183|NCT00963157|Primary|Number of Participants Reporting Solicited Subjective Systemic Reactions After the First Vaccination|Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, nausea, chills, arthralgia, and shivering for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Within 8 days (Day 0-7) post first vaccination|Participants who received the first vaccination are included. Analyses are as treated.||Participants|||Number
800157|NCT00962780|Secondary|Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 2 to 1 month after 13vPnC Dose 3 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws.|1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3|"Evaluable immunogenicity population. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies participants with valid and determinate assay results for specified serotype at both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws for each treatment arm, respectively."||fold rise||95% Confidence Interval|Geometric Mean
800158|NCT00962780|Secondary|Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 2 to 1 month after 13vPnC Dose 3 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws.|1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3|"Evaluable immunogenicity population. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies participants with valid and determinate assay results for specified serotype at both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws for each treatment arm, respectively."||fold rise||95% Confidence Interval|Geometric Mean
800159|NCT00962780|Secondary|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants|Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of pediatric, adult and all participants using a microcolony OPA (mcOPA) assay. GMT (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws. CI for GMT were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3|"Evaluable immunogenicity population. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies participants with valid and determinate assay results for specified serotype at both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws for each treatment arm, respectively."||titers||95% Confidence Interval|Geometric Mean
800160|NCT00962780|Secondary|Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants|Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for pediatric, adult and all participants are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated. Geometric means were calculated using all participants with available data for both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3|"Evaluable immunogenicity population. Here “N” (number of participants analyzed) signifies all participants who were evaluable for this measure and n signifies all participants who were evaluable for specified serotype for each treatment arm, respectively."||microgram per milliliter (mcg/mL)||95% Confidence Interval|Geometric Mean
800161|NCT00962780|Primary|Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in All Participants|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 2 to 1 month after 13vPnC Dose 3 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws.|1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3|Evaluable immunogenicity population:eligible participants who received vaccination as assigned;had blood drawn within pre-specified time-frames;had at least 1 valid, determinate assay result; had no major protocol violation. N (number of participants analyzed)=participants evaluable for this measure, n=participants evaluable for specified serotype.||fold rise||95% Confidence Interval|Geometric Mean
800162|NCT00962871|Secondary|Early Changes in Viral Sequence Associated With Viral Suppression|Viral sequence data was obtained from the first 10 participants enrolled in Study but on analysis of the data, numerous low frequency deviations from the HBV consensus sequences were observed in the 454 SLX sequence data which were not replicated in data obtained from routine Sanger sequencing. These sequence deviations did not correspond to a temporal pattern consistent with selection of mutations following HBV treatment. Moreover, they could not be reliably distinguished from sequencing artifacts. It was also revealed that complete genome coverage was not obtained due to errors in the design of the primer sequences. For these reasons, further sequence analyses were not performed for the remaining treatment population.|Day 1, 5, 14, Week 4 and 6||||||
800163|NCT00962871|Secondary|Mean Change From Baseline in HBV-DNA log10|An acute virologic response was determined by change from baseline in HBV-DNA log10.|Day 1, 3, 5, 8, 10, 14, Week 3, 4, 5, 6 (weeks are computed from the first dose of Pegasys)|All participants who received at least 1 dose of the study medication were included in this analysis. Only participants with both a baseline value and a value particular time point were summarized.||IU/mL||Standard Deviation|Mean
800287|NCT00954707|Secondary|Rate of Target Vessel Failure (TVF)|Defined as target vessel revascularization, recurrent infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vessel.|12 Months|ITT Population patients with the specific event prior to end of follow-up plus patients without that event but with death or adequate follow-up (within 1 month prior to end of scheduled 12 months follow-up).||participants|||Number
800166|NCT00963157|Primary|Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 8 Days Following the First Dose of H1N1 Vaccine|Blood was collected from all participants 8 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 8 after the first vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint are included. One participant was excluded due to influenza-like illness. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
800167|NCT00963157|Primary|Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the first vaccination|Participants who received the H1N1 vaccination and from whom blood was collected within 7 days of the window are included. One participant was excluded due to eligibility deviation and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
800168|NCT00963157|Primary|Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 8 Days Following the First Dose of H1N1 Vaccine|Blood was collected from all participants 8 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 8 after the first vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint are included. One participant was excluded due to eligibility deviation. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
800169|NCT00963157|Primary|Number of Participants Reporting Solicited Quantitative Local Reactions After the Second Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of redness and swelling for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Within 8 days (Day 0-7) post second vaccination|Participants who received the second vaccination are included. Analyses are as treated.||Participants|||Number
800170|NCT00963157|Primary|Number of Participants Reporting Solicited Quantitative Local Reactions After the First Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of redness and swelling for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Within 8 days (Day 0-7) post first vaccination|Participants who received the first vaccination are included. Analyses are as treated.||Participants|||Number
800171|NCT00963157|Primary|Number of Participants Reporting Solicited Subjective Local Reactions After the Second Vaccination|Participants maintained a memory aid to record daily the occurrence of local symptoms of pain, tenderness and swelling for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Within 8 days (Day 0-7) post second vaccination|Participants who received the second vaccination are included. Analyses are as treated.||Participants|||Number
800172|NCT00963157|Primary|Number of Participants Reporting Solicited Subjective Local Reactions After the First Vaccination|Participants maintained a memory aid to record daily the occurrence of local symptoms of pain, tenderness and swelling for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Within 8 days (Day 0-7) post first vaccination|Participants who received the first vaccination are included. Analyses are as treated.||Participants|||Number
800173|NCT00963157|Primary|Number of Participants Reporting Fever After the Second Vaccination|Participants were provided a thermometer and a memory aid to record daily oral temperatures for 8 days (Day 0-7) after vaccination. Participants are counted as experiencing fever if they reported oral temperatures of 38 degrees Celsius or higher on any of the 8 days.|Within 8 days (Day 0-7) post second vaccination|Participants who received the second vaccination and reported oral temperatures during the time period are included. Analyses are as treated.||Participants|||Number
800174|NCT00963157|Primary|Number of Participants Reporting Fever After the First Vaccination|Participants were provided a thermometer and a memory aid to record daily oral temperatures for 8 days (Day 0-7) after vaccination. Participants are counted as experiencing fever if they reported oral temperatures of 38 degrees Celsius or higher on any of the 8 days.|Within 8 days (Day 0-7) post first vaccination|Participants who received the first vaccination and reported oral temperatures during the time period are included. Analyses are as treated.||Participants|||Number
800175|NCT00963157|Secondary|Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 270 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 270 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 270 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 270 days after the second H1N1 vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected within 14 days of the window are included. One participant was excluded due to influenza-like illness and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
800346|NCT00955487|Secondary|Necrotizing Enterocolitis (NEC)|Number of participants diagnosed with necrotizing enterocolitis|After randomization through hospital discharge|||Participants|||Count of Participants
800176|NCT00963157|Secondary|Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 180 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 180 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 180 days after the second H1N1 vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected within 14 days of the window are included. One participant was excluded due to influenza-like illness and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
800177|NCT00963157|Secondary|Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 21 days after the second H1N1 vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected within 7 days of the window are included. One participant was excluded due to influenza-like illness and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
800178|NCT00963157|Secondary|Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 8 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 8 days after the second H1N1 vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected are included. One participant was excluded due to influenza-like illness and one due to receipt of off-study vaccine. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
800179|NCT00963157|Secondary|Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 270 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 270 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 270 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 270 days after the second H1N1 vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected within 14 days of the window are included. Two participants were excluded due to eligibility deviations, one due to receipt of the wrong second dose, and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
800180|NCT00963157|Secondary|Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 180 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 180 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 180 days after the second H1N1 vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected within 14 days of the window are included. Two participants were excluded due to eligibility deviations, one due to receipt of the wrong second dose, and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
800181|NCT00963157|Secondary|Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 21 days after the second H1N1 vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected within 7 days of the window are included. One participant was excluded due to eligibility deviation, one due to receipt of the wrong second dose, and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
800182|NCT00963157|Primary|Number of Participants Reporting Solicited Subjective Systemic Reactions After the Second Vaccination|Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, nausea, chills, arthralgia, and shivering for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Within 8 days (Day 0-7) post second vaccination|Participants who received the second vaccination are included. Analyses are as treated.||Participants|||Number
800234|NCT00963469|Secondary|Patient's Global Evaluation of Allergic Rhinitis After First 2 Weeks of Treatment|An evaluation by the patient, administered after the first 2 weeks of treatment using a 7-point scale [Score 0 (best) to 6 (worst)], of the change in symptoms as compared to the beginning of the study.|After first 2 weeks of treatment|The primary efficacy analyses were based on the intention-to-treat. Since only 1 measurement was obtained during the treatment period, no missing values were imputed.||Scores on a scale||95% Confidence Interval|Least Squares Mean
800184|NCT00963157|Primary|Number of Participants With Chemistry Laboratory Adverse Events After the Second Vaccination|Blood was drawn 8-10 days after vaccination to assess laboratory parameters at a central laboratory. Adverse events (AE) were any values that were Grade 1 or greater for the following parameters: sodium (AE >146 or <135 mEq/L), potassium (>5.3 or <3.5 mEq/L), creatinine (>1.4 mg/dL), Alanine transaminase (>52.7 U/L), Albumin (<3.2 g/dL), and total protein (<6.0 g/dL participants age 18-64 years, <5.8 g/dL participants age 65 years and older). These parameters were not evaluated prior to enrollment as an assessment of eligibility.|8-10 days after second vaccination|Participants who received at least the first vaccination and had blood collected with results reported at the timepoint are included. Analyses are as treated.||Participants|||Number
800185|NCT00963157|Secondary|Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 8 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 8 days after the second H1N1 vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected are included. One participant was excluded due to eligibility deviation, one due to receipt of the wrong second dose, and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
800186|NCT00963157|Secondary|Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 270 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 270 days after second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 270 after the second vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected within 14 days of window are included. One participant was excluded due to influenza-like illness and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
800187|NCT00963157|Secondary|Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 180 days after second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 180 after the second vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected within 14 days of window are included. One participant was excluded due to influenza-like illness and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
800188|NCT00963157|Secondary|Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 21 days after second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the second vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected within 7 days of window are included. One participant was excluded due to influenza-like illness and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
800189|NCT00963157|Secondary|Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 8 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 8 days after second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 8 after the second vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected are included. One participant was excluded due to influenza-like illness and one due to receipt of off-study vaccine. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
800190|NCT00963157|Secondary|Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 270 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 270 days after second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 270 after the second vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected within 14 days of window are included. Two participants were excluded due to eligibility deviations, one due to receipt of the wrong second dose, and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
800191|NCT00963157|Secondary|Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 180 days after second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 180 after the second vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected within 14 days of window are included. Two participants were excluded due to eligibility deviations, one due to receipt of the wrong second dose, and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
800193|NCT00963157|Primary|Number of Participants With Hematology Laboratory Adverse Events After the Second Vaccination|Blood was drawn 8-10 days after vaccination to assess laboratory parameters at a central laboratory. Adverse events (AE) were any values that were Grade 1 or greater for the following parameters: prothrombin time (AE >12.6 seconds), partial thromboplastin time (>40.7 seconds), platelets (>=401,000 or <=129,000 cells/square millimeter), white blood cells (>10,800 or <3800 cells/microliter), neutrophils (>8000 or <1800 cells/microliter), and lymphocytes(>4100 or <850 cells/microliter). These parameters were not evaluated prior to enrollment as an assessment of eligibility.|8-10 days after second vaccination|Participants who received at least the first vaccination and had blood collection at the timepoint are included. Analyses are as treated.||Participants|||Number
800194|NCT00963157|Primary|Number of Participants With Hematology Laboratory Adverse Events After the First Vaccination|Blood was drawn 8-10 days after vaccination to assess laboratory parameters at a central laboratory. Adverse events (AE) were any values that were Grade 1 or greater for the following parameters: prothrombin time (AE >12.6 seconds), partial thromboplastin time (>40.7 seconds), platelets (>=401,000 or <=129,000 cells/square millimeter), white blood cells (>10,800 or <3800 cells/microliter), neutrophils (>8000 or <1800 cells/microliter), and lymphocytes(>4100 or <850 cells/microliter). These parameters were not evaluated prior to enrollment as an assessment of eligibility.|8-10 days after first vaccination|Participants who received the first vaccination and had blood collected with results reported at the timepoint are included. Analyses are as treated.||Participants|||Number
800195|NCT00963157|Secondary|Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 21 days after second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the second vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected within 7 days of window are included. One participant was excluded due to eligibility deviation, one due to receipt of the wrong second dose, and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
800196|NCT00963157|Secondary|Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 8 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 8 days after second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 8 after the second vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected are included. One participant was excluded due to eligibility deviation, one due to receipt of the wrong second dose, and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
800197|NCT00963157|Primary|Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)|Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof; resulted in a congenital anomaly/birth defect; may have jeopardized the participant or required intervention to prevent one of these outcomes; or was described as Guillain-Barré Syndrome. Association to vaccination was determined by a study clinician licensed to make medical diagnoses.|Day 0 through Day 365 after the last vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated.||Participants|||Number
800198|NCT00963157|Primary|Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 21 days after the first H1N1 vaccination|Participants who received the H1N1 vaccination and from whom blood was collected within 7 days of the window are included. One participant was excluded due to influenza-like illness. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
800199|NCT00963157|Primary|Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 8 Days Following the First Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 8 days after the first H1N1 vaccination|Participants who received the H1N1 vaccination and from whom blood was collected are included. One participant was excluded due to influenza-like illness. This outcome restricts to age stratum.||Participants|||Number
800200|NCT00963157|Primary|Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 21 days after the first H1N1 vaccination|Participants who received the H1N1 vaccination and from whom blood was collected within 7 days of the window are included. One participant was excluded due to eligibility deviation and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
822936|NCT01165983|Secondary|Absolute Change in Inflammatory Cytokines and Growth Factors, IL-8, pg/mL||12 Weeks post-randomization|||pg/mL||Inter-Quartile Range|Median
800201|NCT00963157|Primary|Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 8 Days Following the First Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 8 days after the first H1N1 vaccination|Participants who received the H1N1 vaccination and from whom blood was collected are included. One participant was excluded due to an eligibility deviation. This outcome restricts to age stratum.||Participants|||Number
800202|NCT00963235|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3|Specific systemic events (fever >=38 degrees C, fatigue, headache, vomiting, diarrhea, new generalized muscle/joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, new generalized muscle and joint pain were scaled as: Any (symptom present); Mild (no interference with activity); Moderate (some interference); Severe (prevents routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hrs); Moderate (>2 times in 24 hrs); Severe (requires intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hrs); Moderate (4-5 loose stools 24 hrs); Severe (>=6 loose stools in 24 hrs).|Within 14 days post-dose 3|Safety population:participants who received at least 1 dose of study vaccine. ‘N’(number of participants analyzed)=participants whose response was “Yes” for any day or “No” for all days. ‘n’ = participants whose response was “Yes” for any day or “No” for all days for specified systemic event. Participants may be represented in more than 1 category.||percentage of participants||95% Confidence Interval|Number
800203|NCT00963235|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2|Specific systemic events (fever >=38 degrees C, fatigue, headache, vomiting, diarrhea, new generalized muscle/joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, new generalized muscle and joint pain were scaled as: Any (symptom present); Mild (no interference with activity); Moderate (some interference); Severe (prevents routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hrs); Moderate (>2 times in 24 hrs); Severe (requires intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hrs); Moderate (4-5 loose stools 24 hrs); Severe (>=6 loose stools in 24 hrs).|Within 14 days post-dose 2|Safety population:participants who received at least 1 dose of study vaccine. ‘N’(number of participants analyzed)=participants whose response was “Yes” for any day or “No” for all days. ‘n’ = participants whose response was “Yes” for any day or “No” for all days for specified systemic event. Participants may be represented in more than 1 category.||percentage of participants||95% Confidence Interval|Number
800204|NCT00963235|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1|Specific systemic events (fever greater than or equal to [>=]38 degrees Celsius[C], fatigue, headache, vomiting, diarrhea, new generalized muscle/joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, new generalized muscle and joint pain were scaled as: Any (symptom present); Mild (no interference with activity); Moderate (some interference); Severe (prevents routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours [hrs]); Moderate (>2 times in 24 hrs); Severe (requires intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hrs); Moderate (4-5 loose stools 24 hrs); Severe (>=6 loose stools in 24 hrs). Report of fever >40 degrees C after 13vPnC Dose 1 was confirmed as data entry error.|Within 14 days post-dose 1|Safety population:participants who received at least 1 dose of study vaccine. ‘N’(number of participants analyzed)=participants whose response was “Yes” for any day or “No” for all days. ‘n’ = participants whose response was “Yes” for any day or “No” for all days for specified systemic event. Participants may be represented in more than 1 category.||percentage of participants||95% Confidence Interval|Number
800205|NCT00963235|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3|Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 cm); Moderate (5.5 to 10.0 cm); Severe (>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating).|Within 14 days post-dose 3|Safety population:participants who received at least 1 dose of study vaccine. ‘N’(number of participants analyzed)=participants whose response was “Yes” for any day or “No” for all days. ‘n’ = participants whose response was “Yes” for any day or “No” for all days for specified local reaction. Participants may be represented in more than 1 category.||percentage of participants||95% Confidence Interval|Number
800206|NCT00963235|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2|Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 cm); Moderate (5.5 to 10.0 cm); Severe (>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating).|Within 14 days post-dose 2|Safety population:participants who received at least 1 dose of study vaccine. ‘N’(number of participants analyzed)=participants whose response was “Yes” for any day or “No” for all days. ‘n’ = participants whose response was “Yes” for any day or “No” for all days for specified local reaction. Participants may be represented in more than 1 category.||percentage of participants||95% Confidence Interval|Number
800235|NCT00963469|Secondary|Mean Change From Baseline in Daytime Eye Symptoms Score Over First 2 Weeks of Treatment Period|"Mean change from baseline in Daytime Eye Symptoms scores.
Patients were asked to rate each of the 4 eye symptom of tearing, itchy, red, and puffy eyes daily on a 4-point scale [Score 0 (best) to 3 (worst)]. The average of the 4 individual eye symptoms scores was reported as the Daytime Eye Symptoms Score."|Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement through the first 2 weeks of treatment were included||Scores on a scale||95% Confidence Interval|Least Squares Mean
800207|NCT00963235|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1|Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters [cm]); Moderate (5.5 to 10.0 cm); Severe (greater than [>] 10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating).|Within 14 days post-dose 1|Safety population:participants who received at least 1 dose of study vaccine. ‘N’(number of participants analyzed)=participants whose response was “Yes” for any day or “No” for all days. ‘n’ = participants whose response was “Yes” for any day or “No” for all days for specified local reaction. Participants may be represented in more than 1 category.||percentage of participants||95% Confidence Interval|Number
800208|NCT00963235|Secondary|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 1 of 13vPnC to 1 Month After Dose 2 of 13vPnC|GMFRs for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month post-dose 1 to 1 month post-dose 2 were computed using the logarithmically transformed assay results. CI for the GMFRs were back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.|1 month post-dose 1, 1 month post-dose 2|Evaluable immunogenicity population: eligible participants who were >=18 years of age on the day of first vaccination, received at least 2 doses of 13vPnC in the sequence assigned, had valid and determinate assay results, and had no major protocol violations. N (number of participants analyzed)=participants who were evaluable for this measure.||fold rise||95% Confidence Interval|Geometric Mean
800209|NCT00963235|Secondary|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnC|GMFRs for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month post-dose 2 to 1 month post-dose 3 were computed using the logarithmically transformed assay results. CI for the GMFRs were back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.|1 month post-dose 2, 1 month post-dose 3|Evaluable immunogenicity population: eligible participants who were >=18 years of age on the day of first vaccination, received at least 2 doses of 13vPnC in the sequence assigned, had valid and determinate assay results, and had no major protocol violations. N (number of participants analyzed)=participants who were evaluable for this measure.||fold rise||95% Confidence Interval|Geometric Mean
800210|NCT00963235|Secondary|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC|Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using a microcolony OPA (mcOPA) assay. GMT (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for both post-dose 2 and post-dose 3 blood draws.|1 month post-dose 1, 1 month post-dose 2|Evaluable immunogenicity population: eligible participants who were >=18 years of age on the day of first vaccination, received at least 2 doses of 13vPnC in the sequence assigned, had valid and determinate assay results, and had no major protocol violations. N (number of participants analyzed)=participants who were evaluable for this measure.||titers||95% Confidence Interval|Geometric Mean
800211|NCT00963235|Secondary|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC|Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using a microcolony OPA (mcOPA) assay. GMT (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for both post-dose 2 and post-dose 3 blood draws.|1 month post-dose 2, 1 month post-dose 3|Evaluable immunogenicity population: eligible participants who were >=18 years of age on the day of first vaccination, received at least 2 doses of 13vPnC in the sequence assigned, had valid and determinate assay results, and had no major protocol violations. N (number of participants analyzed)=participants who were evaluable for this measure.||titers||95% Confidence Interval|Geometric Mean
800212|NCT00963235|Secondary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC|Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for both post-dose 1 and post-dose 2 blood draws.|1 month post-dose 1, 1 month post-dose 2|Evaluable immunogenicity population: eligible participants who were >=18 years of age on the day of first vaccination, received at least 2 doses of 13vPnC in the sequence assigned, had valid and determinate assay results, and had no major protocol violations. N (number of participants analyzed)=participants who were evaluable for this measure.||mcg/mL||95% Confidence Interval|Geometric Mean
800213|NCT00963235|Secondary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC|Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated. Geometric means (GMs) were calculated using all participants with available data for both post-dose 2 and post-dose 3 blood draws.|1 month post-dose 2, 1 month post-dose 3|Evaluable immunogenicity population: eligible participants who were >=18 years of age on the day of first vaccination, received at least 2 doses of 13vPnC in the sequence assigned, had valid and determinate assay results, and had no major protocol violations. N (number of participants analyzed)=participants who were evaluable for this measure.||microgram per milliliter (mcg/mL)||95% Confidence Interval|Geometric Mean
800236|NCT00963469|Secondary|Mean Change From Baseline in Composite Symptoms Score (Daytime Nasal and Nighttime Symptoms) Over First 2 Weeks of Treatment Period|Composite Symptoms Scores were computed as the average of Daytime Nasal Scores [Score 0 (best) to 3 (worst)] and Nighttime Symptoms Scores [Score 0 (best) to 3 (worst)].|Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement through the first 2 weeks of treatment were included||Scores on a scale||95% Confidence Interval|Least Squares Mean
800214|NCT00963235|Primary|Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnC|Geometric mean fold rises (GMFRs) for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month post-dose 2 to 1 month post-dose 3 were computed using the logarithmically transformed assay results. Confidence interval (CI) for the GMFRs were back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.|1 month post-dose 2, 1 month post-dose 3|Evaluable immunogenicity population: eligible participants who were >=18 years of age on the day of first vaccination, received at least 2 doses of 13vPnC in the sequence assigned, had valid and determinate assay results, and had no major protocol violations. N (number of participants analyzed)=participants who were evaluable for this measure.||fold rise||95% Confidence Interval|Geometric Mean
800215|NCT00963430|Primary|Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)|Serious adverse events included any untoward medical occurrence that resulted in death of the mother, fetus or infant; was life threatening to mother, fetus or infant; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof; was a congenital anomaly/birth defect in fetus or infant; or may have jeopardized the mother, fetus or infant, or required intervention to prevent one of the outcomes, or was described as Guillain-Barré Syndrome. Association was determined by a clinician licensed to diagnose and listed on the site's FDA Form 1572.|Day 0 through Day 180 after last vaccination|All participants receiving the first vaccination are included in the ITT safety cohort.||Participants|||Number
800216|NCT00963430|Secondary|Number of Participants With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus Following 2 Doses of H1N1 Vaccine|Blood was collected from all participants at Day 21 post second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the second vaccination|Participants were included in the analyses if they received both vaccinations within 4 days of the window and had blood collected at both timepoints, with 13 participants excluded due to receipt of non-study vaccines. Participants were analyzed as treated.||Participants|||Number
800217|NCT00963430|Primary|Number of Participants Reporting Neonatal Complications|Participants were contacted after delivery, and medical records reviewed, to collect neonatal complications. The data collection process followed a prospectively-defined list of complications reported for this outcome measure, some of which may have also been reported as serious adverse events if otherwise meeting those requirements.|At time of delivery|All live births are included in this outcome measure, which excludes 2 participants whose pregnancies ended in miscarriage or stillbirth. Three participants gave birth to twins and one to triplets, each counted separately.||Participants|||Number
800218|NCT00963430|Primary|Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery|Participants were contacted after delivery, and medical records reviewed, to collect complications experienced during pregnancy, labor and delivery. The data collection process followed a prospectively-defined list of complications reported for this outcome measure, some of which may have also been reported as serious adverse events if otherwise meeting those requirements.|At time of delivery|All participants from whom outcome data were collected are included in the ITT safety population for this outcome measure.||Participants|||Number
800219|NCT00963430|Primary|Number of Participants With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus Following a Single Dose of H1N1 Vaccine|Blood was collected from all participants at Day 21 post first vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at the timepoint, with 5 participants excluded due to receipt of non-study vaccines. Participants were analyzed as treated.||Participants|||Number
800220|NCT00963430|Primary|Number of Participants With 4-fold or Greater Serum Hemagglutination Inhibition (HAI) Antibody Titer Increases Against Influenza H1N1 2009 Virus Following a Single Dose of H1N1 Vaccine|Blood was collected from all participants prior to the initial vaccination as well as 21 days after the first vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 post vaccination titer was an increase by 4-fold or more.|Day 0 prior to and Day 21 after the first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints, with 5 participants excluded due to receipt of non-study vaccines. Participants were analyzed as treated.||Participants|||Number
800221|NCT00963430|Primary|Number of Participants Reporting Fever After Second Vaccination|Participants were provided with a thermometer and a memory aid on which to record daily oral temperatures for 8 days after vaccination (Day 0-7). The protocol defined fever as oral temperature of 37.8 degrees Celsius or higher. Participants are counted as experiencing fever if they reported oral temperatures of 37.8 degrees Celsius or higher on any of the 8 days.|Within 8 days (Day 0-7) post second vaccination|All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated.||Participants|||Number
800222|NCT00963430|Primary|Number of Participants Reporting Fever After First Vaccination|Participants were provided with a thermometer and a memory aid on which to record daily oral temperatures for 8 days after vaccination (Day 0-7). The protocol defined fever as oral temperature of 37.8 degrees Celsius or higher. Participants are counted as experiencing fever if they reported oral temperatures of 37.8 degrees Celsius or higher on any of the 8 days.|Within 8 days (Day 0-7) post first vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated.||Participants|||Number
800250|NCT00963599|Secondary|Mean Change From Baseline in Daytime Rhinorrhea Score|Patients were asked to rate the nasal symptom of Rhinorrhea daily on a 4-point scale (0 (best) to 3 (worst)).|Baseline and Week 2|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.||Units on a Scale||95% Confidence Interval|Least Squares Mean
800224|NCT00963430|Secondary|Number of Participants With 4-fold or Greater Serum Hemagglutination Inhibition (HAI) Antibody Titer Increases Against Influenza H1N1 2009 Virus Following 2 Doses of H1N1 Vaccine|Blood was collected from all participants prior to the initial vaccination as well as 21 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post vaccination 2 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 post vaccination 2 titer was an increase by 4-fold or more.|Day 0 prior to first vaccination and Day 21 after the second vaccination|Participants were included in the analyses if they received both vaccinations within 4 days of the window and had blood collected at both timepoints, with 13 participants excluded due to receipt of non-study vaccines. Participants were analyzed as treated.||Participants|||Number
800225|NCT00963430|Secondary|Number of Participants With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer Greater Than or Equal to 40 Against the Novel Influenza H1N1 2009 Virus in Cord Blood|Cord blood was collected at the time of delivery for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|At time of delivery|Participants were included in the analyses if a cord blood sample was collected at delivery, with 22 participants excluded due to receipt of non-study vaccines and 5 due to specimen processing errors at the time of sample collection.||Participants|||Number
800226|NCT00963430|Secondary|Number of Participants With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer Greater Than or Equal to 40 Against the Novel Influenza H1N1 2009 Virus in the Maternal Blood at the Time of Delivery|Blood was collected from participants at the time of delivery for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|At time of delivery|Participants were included in the analyses if they had blood collected at delivery, with 22 participants excluded due to receipt of non-study vaccines and 3 due to specimen processing errors at the time of sample collection. Participants were analyzed as treated.||Participants|||Number
800227|NCT00963430|Primary|Number of Participants Reporting Solicited Subjective Systemic Reactions After First Vaccination|Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Within 8 days (Day 0-7) post first vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated.||Participants|||Number
800228|NCT00963430|Primary|Number of Participants Reporting Solicited Quantitative Local Reactions After Second Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of redness and swelling for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Within 8 days (Day 0-7) post second vaccination|All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated.||Participants|||Number
800229|NCT00963430|Primary|Number of Participants Reporting Solicited Quantitative Local Reactions After First Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of redness and swelling for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Within 8 days (Day 0-7) post first vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated.||Participants|||Number
800230|NCT00963430|Primary|Number of Participants Reporting Solicited Subjective Local Reactions After Second Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.|Within 8 days (Day 0-7) post second vaccination|All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated.||Participants|||Number
800231|NCT00963430|Primary|Number of Participants Reporting Solicited Subjective Local Reactions After First Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.|Within 8 days (Day 0-7) post first vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated.||Participants|||Number
800232|NCT00963469|Secondary|Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score After First 2 Weeks of Treatment Period|Patients completed a Rhinoconjunctivitis Quality-of-Life Questionnaire-28 questions on a 7-point scale [0(best) to 6(worst)] across 7 domains: activity,sleep,non-nose/eye symptoms,practical problems,nasal symptoms, eye symptoms, and emotions. The scores for each domain were averaged, then scores for the 7 domains were averaged for an overall score.|Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement through the first 2 weeks of treatment were included||Scores on a scale||95% Confidence Interval|Least Squares Mean
800233|NCT00963469|Secondary|Physician's Global Evaluation of Allergic Rhinitis After First 2 Weeks of Treatment|An evaluation by the physician, administered after the first 2 weeks of treatment using a 7-point scale [Score 0 (best) to 6 (worst)], of the change in symptoms as compared to the beginning of the study.|After first 2 weeks of treatment|The primary efficacy analyses were based on the intention-to-treat. Since only 1 measurement was obtained during the treatment period, no missing values were imputed.||Scores on a scale||95% Confidence Interval|Least Squares Mean
805056|NCT01002339|Secondary|Renal Function|Estimated Glomerular Filtration Rate (ml/min/1.73 m^2)|1 year|Participants analyzed: Participants living with a functioning graft at study end.||ml/min/1.73 m^2||95% Confidence Interval|Mean
800237|NCT00963469|Secondary|Mean Change From Baseline in Nighttime Symptoms Score Over First 2 Weeks of Treatment Period|"Mean change from baseline in Nighttime Symptoms Score.
Patients were asked to rate each symptom daily on a 4-point scale [Score 0 (best) to 3 (worse)], and the combined score of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings was reported as the Nighttime Symptoms Score."|Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement through the first 2 weeks of treatment were included||Scores on a scale||95% Confidence Interval|Least Squares Mean
800238|NCT00963469|Primary|Mean Change From Baseline in Daytime Nasal Symptoms Score Over First 2 Weeks of Treatment Period|"Mean change from baseline in Daytime Nasal Symptoms Score.
Patients were asked to rate each nasal symptom of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4- point scale [Score 0 (best) to 3 (worse)]. The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal Symptoms Score."|Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement through the first 2 weeks of treatment were included.||Scores on a scale||95% Confidence Interval|Least Squares Mean
800239|NCT00963482|Secondary|Drinking in the Last 7 Days (Patients Report + Urine Sample)||6 months||||||
800240|NCT00963482|Primary|Number of Smoke-free Patients|"Smoke-free defined with following measures:
patients self-report about smoking in the last 7 days (yes/no)
CO-level (smoke-free <10ppm)
urine sample (cotinine)"|6 months|Intention-to-treat analysis||participants|||Number
800241|NCT00963508|Secondary|Proportion of Subjects Who Were Considered a Treatment Success 14 Days After Their First Treatment in the Modified ITT (LOCF).|"The secondary efficacy variable was the proportion of subjects who were considered a Treatment Success 14 days after their first treatment.
Treatment Success in the Efficacy ITT (LOCF)"|3 weeks|Proportion of subjects that are lice free 14 days after their first treatment||percentage of subjects|||Number
800242|NCT00963508|Primary|Proportion of Index Subjects Free of Any Lice 14 Days After Their Last Treatment in the Modified ITT (LOCF)|"The primary efficacy variable was the proportion of index subjects who were considered a Treatment Success 14 days after their last treatment (Day 14 visit if only treated on Day 1, Day 21 visit if treated on Day 1 and Day 7)
Treatment Success in the Efficacy ITT (LOCF)
index subjects: 150 from 403 randomized (the youngest subject in the household that met the index case criteria (having nits and at least 3 live lice))"|3 weeks|Efficacy: index subjects who had at least one application of treatment mITT: treated subjects who had at least one post-treatment visit Subjects with missing efficacy data were included first LOCF and then with non-LOCF PP: subjects who complied with the protocol, completed all required visits Safety: all subjects who had at least one treatment||percentage of subjects|||Number
800243|NCT00963560|Primary|Best Corrected Visual Acuity|Best corrected vision was tested at 4 meters (m), 60 centimeters (cm), 40cm and at preferred distance (distance chosen by each subject) with a standard ETDRS chart for distance and a hand held chart for near. Scores were calculated using logMAR values. LogMAR is the “logarithm of the minimum angle of resolution”. A lower logMAR value indicates better visual acuity. Preferred distance for each study group was as follows: ReSTOR +3 = 38.7 +/- 6.8 cm, Crystalens HD = 49.9 +/- 9.8 cm, Crystalens AO = 53.1 +/- 9.8 cm.|6 Months after surgery|2 ReSTOR +3 subjects and 1 Crystalens HD subject missed their final visits and were not included in this analysis.||logMAR||Standard Deviation|Mean
800244|NCT00963599|Secondary|Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score|Patients completed a Rhinoconjunctivitis Quality-of-Life Questionnaire, 28 questions on a 7-point scale [0(best) to 6(worst)] across 7 domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, emotional. Scores per domain were averaged, then scores for the 7 domains were averaged for an overall score.|Week 2|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included. No missing values were imputed.||Units on a Scale||95% Confidence Interval|Least Squares Mean
800245|NCT00963599|Secondary|Physician's Global Evaluation of Allergic Rhinitis|An evaluation by the physician, administered at the last visit (or upon discontinuation) using a 7-point scale, of the change in symptoms as compared to the beginning of the study. Responses were assigned numerical values from 0 (very much better) to 6 (very much worse).|Week 2|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle. Since only 1 measurement was obtained during the treatment period, no missing values were imputed.||Units on a Scale||95% Confidence Interval|Least Squares Mean
800246|NCT00963599|Secondary|Patient's Global Evaluation of Allergic Rhinitis|An evaluation by the patient, administered at the last visit (or upon discontinuation) using a 7-point scale, of the change in symptoms as compared to the beginning of the study. Responses were assigned numerical values from 0 (very much better) to 6 (very much worse).|Week 2|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle. Since only 1 measurement was obtained during the treatment period, no missing values were imputed.||Units on a Scale||95% Confidence Interval|Least Squares Mean
800247|NCT00963599|Secondary|Mean Change From Baseline in Nasal Congestion Upon Awakening|Patients were asked to rate the symptom of Nasal Congestion Upon Awakening daily on a 4-point scale (0 (best) to 3 (worst)).|Baseline and Week 2|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.||Units on a Scale||95% Confidence Interval|Least Squares Mean
800248|NCT00963599|Secondary|Mean Change From Baseline in Daytime Sneezing Score|Patients were asked to rate the nasal symptom of Sneezing daily on a 4-point scale (0 (best) to 3 (worst)).|Baseline and Week 2|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.||Units on a Scale||95% Confidence Interval|Least Squares Mean
800249|NCT00963599|Secondary|Mean Change From Baseline in Daytime Nasal Itching Score|Patients were asked to rate the nasal symptom of Nasal Itching daily on a 4-point scale (0 (best) to 3 (worst)).|Baseline and Week 2|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.||Units on a Scale||95% Confidence Interval|Least Squares Mean
800253|NCT00963599|Secondary|Change From Baseline in Composite Symptoms Score (Daytime Nasal and Nighttime Symptoms)|Composite Symptoms scores were computed as the average of the Daytime Nasal Symptoms scores and Nighttime Symptoms scores collected on a 4 point scale (0 (best) to 3 (worst)).|Baseline and Week 2|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.||Units on a Scale||95% Confidence Interval|Least Squares Mean
800254|NCT00963599|Secondary|Mean Change From Baseline in Nighttime Symptoms Score|Mean change from baseline in Nighttime Symptoms Score. Patients were asked to rate each symptom daily on a 4-point scale (0 (best) to 3 (worst)), and the combined score of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings was reported as the Nighttime Symptoms Score.|Baseline and Week 2|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.||Units on a Scale||95% Confidence Interval|Least Squares Mean
800255|NCT00963599|Primary|Mean Change From Baseline in Daytime Nasal Symptoms Score|Mean change from baseline in Daytime Nasal Symptoms score. Patients were asked to rate each of the 4 nasal symptoms of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4-point scale (0 (best) to 3 (worst)). The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal Symptoms Score.|Baseline and Week 2|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.||Units on a Scale||95% Confidence Interval|Least Squares Mean
800256|NCT00954447|Other Pre-specified|Number of Patients With HbA1c < 6.5 Percent||24 and 52 weeks|FAS (NCF)||Participants|||Number
800257|NCT00954447|Secondary|Change From Baseline in Incremental Post-prandial Glucose (iPPG) After 24 Weeks of Treatment||Baseline and 24 weeks: post-breakfast, post-lunch, post-dinner|FAS (OC)||mmol*hr/L||Standard Deviation|Mean
800258|NCT00954447|Secondary|Change From Baseline in Weighted Mean Daily Glucose After 24 and 52 Weeks of Treatment|Mean Daily Glucose was calculated using the 8-point blood glucose profile|Baseline, 24 and 52 weeks|FAS (OC)||mmol*hr/L||Standard Deviation|Mean
800259|NCT00954447|Secondary|Change From Baseline in Mean Insulin Dose at 52 Weeks of Treatment|Means adjusted for treatment, continous baseline HbA1c, continous baseline weight, continous baseline Insulin, categorical renal function impairment and concomitant OADs|Baseline and 52 weeks|FAS (LOCF)||International units (IU)||Standard Error|Mean
800260|NCT00954447|Secondary|Change From Baseline in FPG||Baseline, 6, 12, 18, 24, 32 and 40 weeks|FAS, observed cases (OC)||mg/dL||Standard Deviation|Mean
800261|NCT00954447|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment||Baseline and 52 weeks|FAS (LOCF), further restricted to patients with a baseline FPG measurement and at least one on-treatment FPG measurement||mg/dL||Standard Deviation|Mean
800262|NCT00954447|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at 24 Weeks of Treatment|Means adjusted for treatment, baseline HbA1c, baseline FPG, categorical renal function impairment and concomitant OADs|Baseline and 24 weeks|FAS (LOCF), further restricted to patients with a baseline FPG measurement and at least one on-treatment FPG measurement||mg/dL||Standard Error|Mean
800263|NCT00954447|Secondary|Change From Baseline in HbA1c by Visit at Week 52|Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs|Baseline and 52 weeks|FAS (LOCF)||Percentage||Standard Error|Mean
800264|NCT00954447|Secondary|Change From Baseline in HbA1c by Visit at Week 40|Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs|Baseline and 40 weeks|FAS (LOCF)||Percentage||Standard Error|Mean
800265|NCT00954447|Secondary|Change From Baseline in HbA1c by Visit at Week 32|Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs|Baseline and 32 weeks|FAS (LOCF)||Percentage||Standard Error|Mean
800266|NCT00954447|Secondary|Change From Baseline in HbA1c by Visit at Week 18|Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs|Baseline and 18 weeks|FAS (LOCF)||Percentage||Standard Error|Mean
800267|NCT00954447|Secondary|Change From Baseline in HbA1c by Visit at Week 12|Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs|Baseline and 12 weeks|FAS (LOCF)||Percentage||Standard Error|Mean
800268|NCT00954447|Secondary|Change From Baseline in HbA1c by Visit at Week 6|Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs|Baseline and 6 weeks|FAS (LOCF)||Percentage||Standard Error|Mean
800269|NCT00954447|Secondary|Number of Patients Lowering HbA1c by at Least 0.5 Percent||24 and 52 weeks|FAS (NCF)||Participants|||Number
800270|NCT00954447|Secondary|Number of Patients With HbA1c < 7.0 Percent||24 and 52 weeks|FAS using the non-completers considered failure (NCF) approach, in which missing data due to premature discontinuation of a patient were considered as failure.||Participants|||Number
800271|NCT00954447|Primary|Change From Baseline in HbA1c After 24 Weeks|HbA1c is measured as a percentage. Adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant Oral antidiabetic drugs (OAD)|Baseline and 24 weeks|The Full Analysis Set (FAS) with a last observation carried forward (LOCF) approach. The FAS comprises all randomised patients who were treated with at least one dose of study medication, had a baseline HbA1c measurement, and had at least one on-treatment HbA1c measurement within the first 24 weeks of double-blind treatment.||Percentage||Standard Error|Mean
800272|NCT00954512|Primary|Part 1: Number of Participants Who Experienced One or More Adverse Events (AEs)|An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to this study drug. AEs may include the onset of new illness and the exacerbation of pre-existing conditions.|Up to ~30 days after the final dose of robatumumab (Up to ~14 months)|The All Treated Set (safety) consisted of all participants who received ≥1 dose of study drug.||Participants|||Number
800273|NCT00954512|Primary|Part 2: Number of Participants With Each Type of Response Evaluation Criteria in Solid Tumors (RECIST)-Determined Overall Best Response|Overall best response was determined by RECIST criteria. Types of overall response could be: Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive Disease (PD), Not Assessable (NA) or Incomplete Response/Stable Disease (IR/SD).|Up to ~30 days after the final dose of robatumumab (Up to ~14 months)|The All Treated Set (efficacy) consisted of all participants who received ≥1 dose of study drug and were evaluable for this outcome measure.||Participants|||Number
800274|NCT00954538|Primary|Least Squares (LS) Mean [18F]MK-3328 SUVR in Brain Posterior Cingulate Gyrus in AD Participants and HE Participants|Using PET brain images acquired after the second dose of [18F]MK-3328, regions of interest (ROIs) were drawn in identified brain areas. The ROIs were projected onto all frames of the dynamic PET scans in order to generate [18F]MK-3328 tissue TACs. Posterior cingulate gyrus SUVR was calculated as the ratio of the average [18F]MK-3328 uptake over 60-90 minutes post dose in the target brain region and the cerebellum.|60-90 minutes after second dose|All participants who received a second dose of [18F]MK-3328 in Part III of study||ratio||95% Confidence Interval|Least Squares Mean
800275|NCT00954538|Primary|Mean Brain Cortical [18F]MK-3328 Standard Uptake Value Ratio (SUVR) in AD Participants and HE Participants|Using PET brain images acquired after dosing, regions of interest (ROIs) were drawn in identified brain areas. The ROIs were projected onto all frames of the dynamic PET scans in order to generate [18F]MK-3328 tissue TACs. SUVR is calculated as the ratio of the average [18F]MK-3328 uptake over 60-90 minutes post dose in the target brain region and the cerebellum. Cortical SUVR is reported, which is a mean SUVR derived from SUVR from multiple brain regions (frontal cortex, parietal cortex, anterior cingulate gyrus, posterior cingulate gyrus, temporal cortex, lateral temporal cortex and occipital cortices).|60-90 minutes post dose|All participants who received [18F]MK-3328 in Part II of study||ratio||Standard Deviation|Mean
800276|NCT00954538|Primary|Organ Effective Dose of [18F]MK-3328|Using PET whole body images acquired after dosing, ROIs were drawn in all organs showing visible [18F]MK-3328 accumulation. TACs showing total [18F]MK-3328 retention as a function of time were determined for each organ. Residence times were calculated from the area under each organ TAC. Radiation exposure of the body and critical organs was calculated from the [18F]MK-3328 residence times using OLINDA software. For each organ, the equivalent dose, which is the absorbed radiation dose weighted for the degree of the biological effect of different types of radiation, was calculated. The organ effective dose is the equivalent dose in each organ multiplied by a weighting factor for the type of tissue exposed. The unit of organ effective dose is Sv.|Up to approximately 6 hours post dose|All participants who received [18F]MK-3328 in Part I of study||µSv/MBq||Standard Deviation|Mean
800277|NCT00954538|Primary|Effective Dose of [18F]MK-3328|Using PET whole body images acquired after dosing, regions of interest (ROIs) were drawn in all organs showing visible [18F]MK-3328 accumulation. Time activity curves (TACs) showing total [18F]MK-3328 retention as a function of time were determined for each organ. Residence times were calculated from the area under each organ TAC. Radiation exposure of the body and critical organs was calculated from the [18F]MK-3328 residence times using OLINDA (Organ Level Internal Dose Assessment) software. For each organ, the equivalent dose, which is the absorbed radiation dose weighted for the degree of the biological effect of different types of radiation, was calculated. The total radiation exposure to the body is expressed as the effective dose, which is the sum of the equivalent doses in each organ multiplied by a weighting factor for the type of tissue exposed. Effective dose is the primary surrogate for radiation risk. The unit of effective dose is the Sievert (Sv).|Up to approximately 6 hours post dose|All participants who received [18F]MK-3328 in Part I of study||µSv/MBq||Standard Deviation|Mean
800278|NCT00954538|Primary|Number of Participants Who Discontinued Study Due to an AE|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug.|Up to 14 days after last dose|All participants who received [18F]MK-3328||participants|||Number
800279|NCT00954538|Primary|Number of Participants With an Adverse Event (AE)|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug.|Up to 14 days after last dose|All participants who received [18F]MK-3328||participants|||Number
800280|NCT00954681|Primary|Maximum Tolerated Dose of Quetiapine|Mean maximum tolerated dose of quetiapine|Weekly|Mean maximum dose of quetipaine achieved||milligrams||Full Range|Mean
800281|NCT00954707|Secondary|Rate of Non-cardiac Death|Include all deaths due to non-cardiac causes.|12 Months|ITT Population patients with the specific event prior to end of follow-up plus patients without that event but with death or adequate follow-up (within 1 month prior to end of scheduled 12 months follow-up)||participants|||Number
800282|NCT00954707|Secondary|Rate of Cardiac Death|Include all deaths due to cardiac causes.|12 Months|ITT Population patients with the specific event prior to end of follow-up plus patients without that event but with death or adequate follow-up (within 1 month prior to end of scheduled 12 months follow-up)||participants|||Number
800283|NCT00954707|Secondary|Rate of Protocol Defined Major Bleeding Complications|Defined by the Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) classification, including severe and moderate bleeding combined.|12 Months|ITT Population patients with the specific event prior to end of follow-up plus patients without that event but with death or adequate follow-up (within 1 month prior to end of scheduled 12 months follow-up)||participants|||Number
800284|NCT00954707|Secondary|Rate of Academic Research Consortium (ARC) Defined Stent Thrombosis (ST)|ARC defined ST classifies ST by type – definite, probable, possible; by timing - acute, sub-acute, late, very late. Definite includes angiographic or pathologic confirmation; probable includes Any unexplained death within the first 30 days or Any MI (related to documented acute ischemia and without another obvious cause) in the territory of the stent; Possible includes Any unexplained death > 30 days. Acute includes those ≤ 24 hours post procedure; sub-acute includes those > 24 hours to ≤ 30 days post procedure; and late includes those > 30 days to ≤ 1 year post procedure; and very late includes those > 1 year post procedure.|12 Months|ITT Population patients with the specific event prior to end of follow-up plus patients without that event but with death or adequate follow-up (within 1 month prior to end of scheduled 12 months follow-up)||participants|||Number
800285|NCT00954707|Secondary|Rate of Protocol Defined Stent Thrombosis (ST)|Protocol defined ST includes early and late ST. Early thrombosis is defined as composite thirty-day ischemic endpoint including death, Q-wave myocardial infarction, or subabrupt closure requiring revascularization. Late thrombosis is defined as myocardial infarction occurring > 30 days after the index procedure and attributable to the target vessel with angiographic documentation (site reported or by qualitative coronary angiography) of thrombus or total occlusion at the target site and freedom from an interim revascularization of the target vessel.|12 Months|ITT Population patients with the specific event prior to end of follow-up plus patients without that event but with death or adequate follow-up (within 1 month prior to end of scheduled 12 months follow-up)||participants|||Number
800288|NCT00954707|Secondary|Rate of Clinically Driven Target Vessel Revascularization (TVR)|Defined as any clinically driven repeat percutaneous intervention of the target vessel or bypass surgery of the target vessel. Clinically-driven revascularizations are those in which the subject has a positive functional study, ischemic ECG changes at rest in a distribution consistent with the target vessel, or ischemic symptoms, and an in-lesion diameter stenosis ≥50% by QCA.|12 months|ITT Population patients with the specific event prior to end of follow-up plus patients without that event but with death or adequate follow-up (within 1 month prior to end of scheduled 12 months follow-up).||participants|||Number
800289|NCT00954707|Secondary|Rate of Clinically-driven Target Lesion Revascularization (TVR)|Defined as any “clinically-driven” repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel. Clinically-driven revascularizations are those in which the subject has a positive functional study, ischemic ECG changes at rest in a distribution consistent with the target vessel, or ischemic symptoms, and an in-lesion diameter stenosis ≥50% by QCA.|12 Months|ITT Population patients with the specific event prior to end of follow-up plus patients without that event but with death or adequate follow-up (within 1 month prior to end of scheduled 12 months follow-up)||participants|||Number
800290|NCT00954707|Secondary|Rate of Procedure Success|Procedure success is defined as the achievement of a final diameter stenosis of < 50% (by QCA) using any percutaneous method, without the occurrence of death, Myocardial infarction (MI), or repeat coronary revascularization of the target lesion during the hospital stay.|From post- procedure to hospital discharge, up to 39 days|Intent-to-Treat Population||participants|||Number
800291|NCT00954707|Secondary|Rate of Lesion Success|Lesion success is defined as the attainment of < 50% residual stenosis (by Quantitative coronary angiography (QCA)) using any percutaneous method.|From post- procedure to hospital discharge, up to 39 days|The total number of lesions the Intent-to-Treat population had at the beginning of the study||Lesions|Participants||Number
800292|NCT00954707|Secondary|Rate of Device Success|A study device success is defined as achievement of a final residual diameter stenosis of < 50% (by QCA), using the assigned device only. If QCA is not available, the visual estimate of diameter stenosis is used.|From post- procedure to hospital discharge, up to 39 days|The total number of devices the Intent-to-Treat patients used in the study.||Devices|Participants||Number
800293|NCT00954707|Primary|Phase I: the Rate of Target Lesion Failure (TLF)|Target lesion failure (TLF) is defined as clinically-driven target lesion revascularization, target vessel myocardial infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vessel at 12 months.|12 months|Active subjects in the ITT population at 12-month post procedure||participants|||Number
800294|NCT00954733|Primary|TcCo2 vs PACo2 Difference|Evaluate the correlation between PaCO2- TcCO2 in detecting hypoventilation for patients undergoing deep sedation Absolute mean difference between TcCo2 and the PA Co2|1 hour|||mmHG||Standard Deviation|Mean
800295|NCT00954824|Primary|The Primary Outcome Measure is Plasma Levels of TNF Alpha.||24 hours|||ng/mL||Standard Deviation|Mean
800296|NCT00954915|Secondary|Teplizumab Blood Levels||Day 0 through Day 84||||||
800297|NCT00954915|Secondary|Physician's Global Assessment (PGA)|The PGA rates the subject’s psoriasis relative to baseline as 1 (100% clearing), 2 (excellent: 75% through 99% clearing with striking improvement), 3 (good: 50% through 74% clearing with moderate improvement), 4 (fair: 25% through 49% clearing with slight improvement), 5 (poor: 0% through 24% clearing with little or no change), or 6 (worsening). Involvement of body-surface area, induration, scaling, and erythema are taken into account.|Day 0, 14, 28, 63 and 84||||||
800298|NCT00954915|Secondary|Number of Participants Improved on the Psoriasis Area and Severity Index (PASI)|The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of plaque scale, erythema, and plaque induration (thickness) in each region, yielding an overall score of 0 for no psoriasis to a maximum of 72 for severe disease.|Day 0, 14, 28, 63 and 84||||||
800299|NCT00954915|Secondary|Number of Participants Improved on Lattice System Physician's Global Assessment (LS-PGA)|The LS-PGA score is determined by estimating the extent of body surface area involved by psoriasis and rating plaque qualities (elevation, erythema, scaling) averaged over the entire body. LS-PGA score is then determined using available software. LS-PGA ranks involvement on an 8 point scale from clear, almost clear, mild, mild to moderate, moderate, moderate to severe, severe, and very severe. Participants who have an improvement of one or more steps in the LS-PGA will be considered to have met the primary criteria for a clinical response.|Day 0, 14, 28, 63 and 84||||||
800300|NCT00954915|Primary|Adverse Events (AE)|Primary endpoints include safety data such as vital signs, physical examinations, electrocardiograms, AE reports, and laboratory test results.|Day 0 through Day 84|One subject was enrolled and followed per protocol. This subject's data are described in the adverse events summary.||Participants|||Number
800301|NCT00954941|Primary|Treatment Success Rate|Treatment success is defined as no nausea, no vomiting and no need for rescue medication (or complete response) within the first 6 treatment days. Treatment success rate defined as percentage of participants achieving treatment success.|First 6 treatment days|Of the 98 participants in the study, six (6) in Group 1: Ondansetron and nine (9) in Group 2: Ondansetron + Aprepitant were not.evaluable.||percentage of participants|||Number
800302|NCT00954941|Primary|Participant Responses|Participant response defined as: Complete response - no emetic episode, no nausea and no rescue medication during the administration of chemotherapy; Partial response - less than or equal to one episode of emesis in 24 hours, no rescue medication, and no more than moderate nausea (grade 2 National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)) during chemotherapy. Vomit was defined as expulsion of stomach contents through the mouth, nausea as stomach distress with distaste for food and an urge to vomit, and rescue medication as antiemetic medications given to treat nausea and/or vomit that did not respond to the initial prophylactic regimen. Treatment success was defined as no nausea, no vomiting and no need for rescue medication within the first 6 treatment days with continuous monitoring.|First 6 treatment days|Of the 98 participants in the study, six (6) in Group 1: Ondansetron and nine (9) in Group 2: Ondansetron + Aprepitant were not.evaluable.||participants|||Number
800326|NCT00955474|Secondary|LDL Blood Levels at Baseline and Week 8.|LDL levels at Baseline and Week 8. Normal range < 100 mg/dl.|8 weeks|Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.||mg/dl||Standard Deviation|Mean
800303|NCT00954993|Primary|Apparent Terminal Half-life (t-1/2) of Vaniprevir in the Liver|Participants were treated with vaniprevir twice daily on days 1,2, and 3. On treatment Day 4 participants were treated once with vaniprevir; then core needle liver biopsies were to be collected at 6, 12 and 24 hours postdose to determine the t-1/2 of vaniprevir. The t-1/2 is the time taken to eliminate half the amount of vaniprevir.|6, 12 and 24 hours postdose on day 4 of each period (up to day 148)|Since only a single liver sample timepoint was obtained from each participant at either 6 or 12 hours, and the 24 hour timepoint was not collected from any participant due to the early termination of the study, the t-1/2 could not be determined.|||||
800304|NCT00954993|Primary|Concentration of Vaniprevir in the Liver|Participants were treated with vaniprevir on days, 1,2, and 3. On treatment Day 4 participants were treated once with vaniprevir; then core needle liver biopsies were collected at 6, 12, and 24 hours postdose to determine the concentration of vaniprevir in the liver.|6, 12 and 24 hours postdose on day 4 of each period (up to day 148)|Participants treated with vaniprevir who had a liver biopsy were analyzed as two separate groups that received 600 mg and 300 mg doses . No biopsies were collected at the 24 hour timepoint.||nM||Full Range|Median
800305|NCT00954993|Primary|Area Under the Curve (AUC) (0-12 Hrs) of Vaniprevir in the Liver|Participants were treated with vaniprevir twice daily on days 1,2, and 3. On treatment Day 4 participants were treated once with vaniprevir; then core needle liver biopsies were to be collected at 6, 12 and 24 hours postdose to determine the AUC of vaniprevir. AUC is the integrated area under the curve for plasma concentration of vaniprevir over time.|6, 12 and 24 hours postdose on day 4 of each period (up to Day 148)|Since only a single liver sample timepoint at either 6 or 12 hours was obtained from each participant, and no 24 hour timepoint was collected from any participant due to the early termination of the study, the AUC (0-12 hrs) was not calculated|||||
800306|NCT00955032|Secondary|Hamilton Depression Rating Scale (HAM-D)|The Hamilton Depression Rating Scale (HAM-D) is a 24-item interviewer administered structure questionaire designed to assess symptoms of depression. Items are scored with a range of 0-4, though 11 of the items are scored between 0 and 2. A total score is then calculated of all items which can range from 0 to 74. A higher score is indicative of more depressive symptoms, and a lower score post-tx is indicative of better outcome.|Pre-Tx; 10 days post-tx|All participants who completed study procedures were included for analyses.||units on a scale||Standard Deviation|Mean
800307|NCT00955032|Secondary|Beck Depression Inventory-Second Edition (BDI-II)|The Beck Depression Inventory-Second Edition (BDI-II) is a 21-item self-report questionaire that measures depressive symptoms. Each item is scored on a scale of 0-3, and items are summated to yield a total score. A higher score is indicative of greater symptoms of depression. Total scores may range between 0 and 63. A score greater than or equal of 14 is suggestive of clinically significant symptoms.|Pre-Tx; 10 days post-tx|All participants who completed study procedures were included for analyses.||units on a scale||Standard Deviation|Mean
800308|NCT00955032|Secondary|Lille Apathy Rating Scale (LARS)|The Lille Apathy Rating Scale (LARS) is a 33-item interviewer administered structured questionaire designed to assess level of apathetic symptoms. The first 3 items are scored from -2 to +2, while the remainder items are scored from -1 to +1. Scores can range between -36 to +36. The more positive the score, the greater level of apathy symptoms.|Pre-Tx; 10 days post-tx|All participants who completed study procedures were included for analyses.||units on a scale||Standard Deviation|Mean
800309|NCT00955032|Primary|Apathy Evaluation Scale (AES)|The apathy evaluation scale is a 14-item self-report questionaire that provides a quantitative estimate of apathy symptoms. Items are given a score of 0-3, and a total score is summated using all items. Scores may range between 0 and 42. Higher scores are indicative of greater symptoms of apathy, and a score of 14 is suggestive of clinically significant symptoms.|Pre-Tx; 10 days post tx|All participants who completed study procedures were included for analyses.||units on a scale||Standard Deviation|Mean
800310|NCT00955110|Primary|High VAS - Emax (mm)|"The High Visual Analog Scale (VAS) consisted of a horizontal line with a statement presented above the bar (I am feeling high). The ends of the line were marked with the descriptive anchors (Definitely not and Definitely so). Using a laptop computer, participants were instructed to click and drag the mouse to the appropriate position along the line, according to how they felt at that moment. Each scale was scored as an integer from 0 (Definitely not) to 100 (Definitely so), representing the position on the line."|High VAS was administered at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose.|Per Protocol population: Subjects who received all 5 treatments and who had no major protocol deviations or other circumstances that would exclude them from the analysis. The pharmacokinetic and pharmacodynamic analyses were performed using the Per Protocol population. No imputation of missing values was performed.||mm||Standard Deviation|Mean
800311|NCT00955266|Secondary|Length of ICU Stay (Days)|Intensive Care Unit length of stay in days.|64 enrolled patients or 9 months following start of protocol, whichever comes first|Data was in paper form only. Data storage location sustained significant water intrusion and mold contamination in June 2016. Environmental contractor has advised paper contents will need to be destroyed under containment conditions to ensure that mold does not spread. As a result, data is not available for results reporting.|||||
800312|NCT00955266|Secondary|Length of Hospital Stay (Days)|Hospital length of stay in days.|64 enrolled patients or 9 months following start of protocol, whichever comes first|Data was in paper form only. Data storage location sustained significant water intrusion and mold contamination in June 2016. Environmental contractor has advised paper contents will need to be destroyed under containment conditions to ensure that mold does not spread. As a result, data is not available for results reporting.|||||
800313|NCT00955266|Secondary|Need for Inotropic or Vasopressor Support Upon Leaving the OR|Use of inotropes or vasopressors in the Operating Room.|64 enrolled patients or 9 months following start of protocol, whichever comes first|Data was in paper form only. Data storage location sustained significant water intrusion and mold contamination in June 2016. Environmental contractor has advised paper contents will need to be destroyed under containment conditions to ensure that mold does not spread. As a result, data is not available for results reporting.|||||
800314|NCT00955266|Secondary|Return to Cardiopulmonary Bypass Secondary to Hemodynamic Instability|Return to Cardiopulmonary bypass Yes/ No|64 enrolled patients or 9 months following start of protocol, whichever comes first|Data was in paper form only. Data storage location sustained significant water intrusion and mold contamination in June 2016. Environmental contractor has advised paper contents will need to be destroyed under containment conditions to ensure that mold does not spread. As a result, data is not available for results reporting.|||||
800315|NCT00955266|Primary|Diastolic Dysfunction|E/ A ratio on TEE. This ratio of peak velocity flow in early diastole (the E wave) to peak velocity flow in late diastole caused by atrial contraction (the A wave) is reflective of degree of diastolic dysfunction.|64 enrolled patients or 9 months following start of protocol, whichever comes first|Data was in paper form only. Data storage location sustained significant water intrusion and mold contamination in June 2016. Environmental contractor has advised paper contents will need to be destroyed under containment conditions to ensure that mold does not spread. As a result, data is not available for results reporting.|||||
800316|NCT00955279|Secondary|Change From Baseline in Percent-predicted Forced Vital Capacity (FVC) at Week 28|Forced vital capacity (FVC) is a standard pulmonary function test used to quantify respiratory muscle weakness. FVC is the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. Predicted forced vital capacity is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FVC = (observed value)/(predicted value) * 100%. Change is calculated as the value at week 28 minus the baseline value.|Baseline (Day 1) and Week 28|mITT population included all the participants who were randomized and who received at least 1 dose of study medication.||percent of predicted FVC||Standard Error|Least Squares Mean
800317|NCT00955279|Secondary|Percentage of Responders With a Score of Less Than or Equal to 1 on Skin Physician's Global Assessment (SPGA) Scale|The SPGA is 7-point scale used to assess the condition of skin in participants. The physician checks the state of the skin and gives them score from 0 (clear) to 5 (severe). Higher scores indicate worsening of skin condition.|Week 28|Secondary population included all the participants with chronic sarcoidosis with skin involvement who have received at least 1 dose of study medication.||Percentage of Participants|||Number
800318|NCT00955279|Secondary|Change From Baseline in the St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 28|St. George's Respiratory Questionnaire (SGRQ) is a health related quality of life questionnaire consisting of 51 items in three components: symptoms, activity, and impacts. The lowest possible value is zero and the highest 100. Higher values correspond to greater impairment in quality of life. Change from Baseline was calculated as the value at Week 28 minus value at Baseline.|Baseline (Day 1) and Week 28|mITT population included all the participants who were randomized and who received at least 1 dose of study medication.||Units on a scale||Standard Error|Least Squares Mean
800319|NCT00955279|Secondary|Change From Baseline in 6-minute Walk Distance at Week 28|Change from Baseline in 6-minute walk distance at Week 28 was calculated as 6-minute walk distance at Week 28 minus 6-minute walk distance at Baseline. The 6-minute walk distance was the total distance walked during the 6-minute walk test.|Baseline (Day 1) and Week 28|mITT population included all the participants who were randomized and who received at least 1 dose of study medication.||meters||Standard Error|Least Squares Mean
800320|NCT00955279|Primary|Change From Baseline in Percent-predicted Forced Vital Capacity (FVC) at Week 16|Forced vital capacity (FVC) is a standard pulmonary function test used to quantify respiratory muscle weakness . FVC was the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. Predicted forced vital capacity is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FVC = (observed value)/(predicted value) * 100%. Change was calculated as the value at Week 16 minus the baseline value.|Baseline (Day 1) and Week 16|Modified intent-to-treat (mITT) population included all the participants who were randomized and who received at least 1 dose of study medication.||percent of predicted FVC||Standard Error|Least Squares Mean
800321|NCT00955305|Secondary|Proportion of Patients With Objective Response|"Objective response was evaluated using the RECIST 1.1 criteria.
Objective response includes complete response (CR) and partial response (PR). Objective response is defined as disappearance of all target lesions or at least a 30% decrease in the sum of the diameters of target lesions. In addition, non-target lesions do not meet the criteria for disease progression and no new lesions were observed."|Assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry; up to 5 years|Eligible and treated patients||Proportion of participants||95% Confidence Interval|Number
800322|NCT00955305|Secondary|Overall Survival (OS)|Overall survival is defined as the time from randomization to death or date last known alive.|Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; up to 5 years|Eligible and treated patients||months||95% Confidence Interval|Median
800323|NCT00955305|Primary|Progression-free Survival (PFS)|"Progression-free survival was defined as the time from randomization to progression or death without documentation of progression. For cases without progression, follow-up was censored at the date of last disease assessment without progression, unless death occurs within 3 months following the date last known progression-free, in which case the death was counted as a failure.
Progression was evaluated using RECIST 1.1 criteria and defined as:
At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study and the sum must also demonstrate an absolute increase of at least 5 mm.
OR
Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions."|Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; up to 5 years|Eligible and treated patients||months||95% Confidence Interval|Median
800324|NCT00955357|Primary|"The Proportion of Subjects Who Achieved Seizure-free Status During the First 12 Weeks of the Maintenance Phase"|"A subject will be considered seizure-free if the subject completes the first 12 weeks of the Maintenance Phase, reports zero seizures, and has no seizure data missing for any day during the period of time.
This study was intended to assess the efficacy outcomes in the First Add-On Group and the Later Add-On Group individually relative to historical data. Comparisons between the 2 groups should not be attempted and conclusions should not be drawn."|From Week 7 (end of Week 6) to end of Week 18|The Analysis Population refers to the Completer Set (CS) which includes all subjects who were enrolled, received at least one dose of Lacosamide and completed the first 12 weeks of the Maintenance Phase.||percentage of subjects|||Number
800325|NCT00955474|Secondary|Blood Hemoglobin A1C at Baseline and Week 8.|Blood hemoglobin A1C at Baseline and Week 8. Normal range: 3.8%-6.4%.|8 weeks|Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.||% glycated hemoglobin||Standard Deviation|Mean
805057|NCT01002339|Secondary|Rejection|Biopsy proven acute rejection. Measured variable: Rate of Biopsy proven acute rejection.|1 year|||percentage of participants||95% Confidence Interval|Number
800329|NCT00955474|Secondary|Blood Level of Total Cholesterol Levels Were Collected at Baseline and Week 8.|Cholesterol levels were collected at Baseline and Week 8. Normal cholesterol levels should be <200mg/dl.|8 weeks|Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.||mg/dl||Standard Deviation|Mean
800330|NCT00955474|Secondary|RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Delayed Memory Subscale Scores at Baseline and Week 8.|RBANS Delayed Memory subscale scores at Baseline and Week 8. Scores range from 40-160, with 160 referring to higher cognitive functioning. All RBANS subscales and the total score are standardized using age-based norms. Thus, they have a mean of 100 (average) and a standard deviation of 15. A score of 90-110 is in the average range; score of 70-85 mild to moderate cognitive impairment; score <70 moderate to severe impairment.|8 weeks|Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.||units on a scale||Standard Deviation|Mean
800331|NCT00955474|Secondary|RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Attention Sub-scale Scores at Baseline and Week 8.|RBANS Attention sub-scale scores at Baseline and Week 8. Scores range from 40-160, with 160 referring to higher cognitive functioning. All RBANS subscales and the total score are standardized using age-based norms. Thus, they have a mean of 100 (average) and a standard deviation of 15. A score of 90-110 is in the average range; score of 70-85 mild to moderate cognitive impairment; score <70 moderate to severe impairment.|8 weeks|Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.||units on a scale||Standard Deviation|Mean
800332|NCT00955474|Secondary|RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Language Sub-scale Score.|RBANS Language sub-scale scores at Baseline and Week 8 of study. Scores range from 40-160, with 160 referring to higher cognitive functioning. All RBANS subscales and the total score are standardized using age-based norms. Thus, they have a mean of 100 (average) and a standard deviation of 15. A score of 90-110 is in the average range; score of 70-85 mild to moderate cognitive impairment; score <70 moderate to severe impairment.|8 weeks|Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.||units on a scale||Standard Deviation|Mean
800333|NCT00955474|Secondary|RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Visuospatial/Constructional Sub-scale.|RBANS Visuospatial/Constructional sub-scales at Baseline and Week 8. Scores range from 40-160, with 160 referring to higher cognitive functioning. All RBANS subscales and the total score are standardized using age-based norms. Thus, they have a mean of 100 (average) and a standard deviation of 15. A score of 90-110 is in the average range; score of 70-85 mild to moderate cognitive impairment; score <70 moderate to severe impairment.|8 weeks|Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.||units on a scale||Standard Deviation|Mean
800334|NCT00955474|Secondary|RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Immediate Memory Sub-scale Score|RBANS Immediate Memory sub-scale scores at Baseline and Week 8. Scores range from 40-160, with 160 referring to higher cognitive functioning. All RBANS subscales and the total score are standardized using age-based norms. Thus, they have a mean of 100 (average) and a standard deviation of 15. A score of 90-110 is in the average range; score of 70-85 mild to moderate cognitive impairment; score <70 moderate to severe impairment.|8 weeks|Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.||units on a scale||Standard Deviation|Mean
800335|NCT00955474|Secondary|RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Total Score|Neuropsychological Assessment. Scores range from 40-160, with 160 referring to higher cognitive functioning. All RBANS subscales and the total score are standardized using age-based norms. Thus, they have a mean of 100 (average) and a standard deviation of 15. A score of 90-110 is in the average range; score of 70-85 mild to moderate cognitive impairment; score <70 moderate to severe impairment. RBANS measured at baseline and 8 weeks.|8|Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.||units on a scale||Standard Deviation|Mean
800336|NCT00955474|Secondary|CPFQ (Cognitive and Psychological Functioning Questionnaire)|Score on the Cognitive and Psychological Functioning Questionnaire (CPFQ). Scores range from 7-42 with 42 referring to the worst functioning. CPFQ measured at baseline and 8 weeks.|8 weeks|Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.||units on a scale||Standard Deviation|Mean
800337|NCT00955474|Secondary|Fasting Blood Glucose|Fasting glucose levels collected at Baseline and Week 8. Normal range for fasting glucose is 70-110 mg/dl.|8 weeks|Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were five completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.||ml/dl||Standard Deviation|Mean
800338|NCT00955474|Primary|Psychosis|Psychosis measured by Brief Psychosis Rating Scale (BPRS) at baseline and 8 weeks. Scores range from 24-168, with 168 bring the most severe.|8 weeks|Complete missing data for 2 subjects in the quetiapine with SSRI group (11 of 13 have baseline outcome measures). There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.||units on a scale||Standard Deviation|Mean
800339|NCT00955474|Primary|Depression|Depression measured with Hamilton Rating Scale for Depression 17 (HAM-D) at baseline and 8 weeks. Ham D 17 scores range from 0-52, 52 being the most severe.|8 weeks|Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were five completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.||units on a scale||Standard Deviation|Mean
800340|NCT00955487|Other Pre-specified|Days in Hospital|Length of stay of participants|From birth to hospital discharge|||Days||Standard Deviation|Mean
800350|NCT00955487|Primary|Combined Endpoint of Bronchopulmonary Dysplasia (BPD) or Mortality Stratified by Birth Weight|Number of participants that developed bronchopulmonary dysplasia and/or that died, stratified by birth weight (grams)|Randomization to discharge|||Participants|||Count of Participants
800351|NCT00955487|Primary|Combined Endpoint of Bronchopulmonary Dysplasia (BPD) or Mortality|Number of participants that developed bronchopulmonary dysplasia and/or that died|Week 36 or earlier, if participants are discharged from the hospital|||Participants|||Count of Participants
800352|NCT00955513|Primary|Measure: Pain on Movement on Day 5 (Change From Baseline).|Visual analog scale (0 to 100 mm) A greater change from baseline equates to a better outcome.|baseline and day 5|||mm||Standard Deviation|Mean
800353|NCT00955617|Secondary|Signal Intensity|Signal to Noise ratio (SNR): SNR = SIa /NO SIa is the signal intensity measured in the ROI positioned in the artery. NO is noise defined as the standard deviation (SD) of signal intensity measured in the subtraction image (of the two non-enhanced scans) at the same location as the arterial ROI is to be measured.|MRA examination|||Ratio||Standard Deviation|Mean
800354|NCT00955617|Secondary|Diagnostic Confidence|"Number of High/Excellent diagnostic confidence. Level of diagnostic confidence assessed on a 5-point scale by patient: nil, poor, moderate, high, excellent.
Each image is analysed by 4 readers."|MRA examination|Descriptive study - No calculation||Images|Participants||Number
800355|NCT00955617|Primary|Overall Image Quality of MRA Images|"Number of images quoted with excellent and more than adequate quality in each group.
Image quality will be assessed on a 5-point scale:
Excellent
More than adequate
Adequate
Less than adequate
Non-diagnostic
Each image is analysed by 4 readers."|MRA examination|descriptive and pilot study, no number of participants calculation performed||Images|Participants||Number
800356|NCT00955721|Secondary|Phase II: Explore Biomarkers of Response to the Combination||9 Months||||||
800357|NCT00955721|Secondary|Phase II: Further Evaluate the Safety of the Proposed Combination||9 Months||||||
800358|NCT00955721|Secondary|Phase II: Estimate Overall Survival||Start of treatment until death||||||
800359|NCT00955721|Secondary|Phase II: Estimate Overall Response Rate and Clinical Benefit Rate.|Overall response rate [CR + PR]. Clinical Benefit Rate [Complete Response (CR) + Partial Response (PR) + Stable Disease (SD)] per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0).|9 Months|||percentage of patients|||Number
800360|NCT00955721|Primary|Phase II: Obtain an Estimate of the 9-month Progression-free Survival Rate in Patients With Advanced BTC Receiving the RPTD of the Combination Sorafenib and GEMOX.||9 Months|The number or participants is too small to obtain an estimate of the progression-free survival.|||||
800361|NCT00955721|Primary|Phase I: Establish the Recommended Phase II Dose (RPTD) of the Combination of Sorafenib and GEMOX in Patients With Advanced Biliary Tract Cancer (BTC).||First two 14-day Phase I cycles||||||
800362|NCT00955747|Primary|Change in Hemoglobin A1C Level From Baseline|The primary efficacy variable will be the change in HbA1c level from baseline. Changes from baseline in HbA1c level at each visit will be assessed with the use of linear model(ANCOVA) to adjust for any baseline difference, as well as the stratification factor.|1 year from baseline|Calculation of the final numbers for study completion considers a standard deviation of 1.4%, a two-sided 95% confidence interval (alpha= 0.025), power of 90%, and the ability to detect a 0.5% difference in HbA1c between treatment and placebo groups.||percentage of change from baseline||Standard Error|Least Squares Mean
800363|NCT00955825|Primary|Combined Score (CS)|"The daily Combined Score (CS) is a patient specific score taking into account the patient’s daily Rhinoconjunctivis Total Symptom Score (RTSS) and daily Rescue Medication Score (RMS), assuming equivalent importance of symptoms and rescue medication scores.
The RMS (range 0-3) is derived as follows: 0, no rescue medication; 1, use of antihistamine; 2, use of nasal corticosteroid; 3, use of oral corticosteroid. The RTSS (range 0-18) is the sum of the 6 individual rhinoconjunctivitis symptom score (each symptom is scored as follows: 0: no symptoms, 1: mild symptoms, 2: moderate symptoms and 3: severe symptoms).
The CS (range 0-3) = (RTSS/6 + RMS)/2. The lower the score, the better the outcome."|Pollen period (average of 42.8 days)|The Full Analysis Set (FAS) includes all patients who received at least one dose of the investigational product and had at least one Combined Score while on treatment during the pollen period. The FAS was regarded as primary for the efficacy evaluations.||Units on a scale (range: 0 to 3)||Standard Error|Least Squares Mean
800364|NCT00955903|Secondary|Weight Change/Maintenance|The change in body weight at follow up of 1 year. Change is calculated as value at baseline minus value at 1 year|Baseline to 1 year|||Kg||Standard Deviation|Mean
800365|NCT00955903|Secondary|Cardiometabolic Risk Factors|We are reporting change in blood glucose. Change is calculated as value at baseline minus value at 1 year|Baseline to 1 year|||mg/dL||Standard Deviation|Mean
800366|NCT00955903|Primary|Change in Abdominal Fat Mass|Visceral adipose tissue (cm3) by MRI. Change is calculated as value at baseline minus value at 1 year|Baseline to 1 year|||Cubic cm||Standard Deviation|Mean
800367|NCT00955916|Secondary|Median Overall Survival (OS)|Overall Survival is defined as the time from randomization until death from any cause.|Up to 3 years|All participants||months||95% Confidence Interval|Median
800368|NCT00955916|Secondary|Median Progression Free Survival (PFS)|Progression Free Survival is defined as the duration of time from start of treatment to time of progression. Leukemia related failure (progressive disease): Failure to induce bone marrow hypoplasia after 2 cycles or regrowth of leukemic blasts ≥ 20%.|Up to 3 years|All participants||months||95% Confidence Interval|Median
800369|NCT00955916|Primary|Overall Response Rate (ORR)|Overall Response Rate: Morphologic Complete Remission (CR) + Morphologic Complete Remission with incomplete blood count recovery (CRi) for evaluable participants. CR - Bone Marrow: < 5% blasts without Auer rods with at least 20% cellularity with maturation of all cell lines, No presence of unique phenotype by flow cytometry identical to what was found in the pretreatment specimen, No persistent dysplasia; Peripheral: normal blood counts, absolute neutrophil count (ANC) > 1.0 k/μl and platelets > 100 k/μl ANC > 1.0 k/μl and platelets > 100 k/μl (Peripheral blood counts documenting recovery can be utilized within 4 weeks of the bone marrow); No evidence of extramedullary leukemia. CRi - All CR criteria are met except for residual Neutropenia <1.0 x 10^9/L platelets < 100 k/μl.|8 weeks per participant|All participants||percentage of participants|||Number
800986|NCT00968019|Secondary|Lesion Success|Lesion success defined as the attainment of <50% final diameter stenosis (by visual estimate) using any percutaneous method.|Peri-procedure up to discharge|318 patients treated with the Presillion stent in up to two de novo coronary artery lesions (354 lesions)||percentage of lesion Success|Participants||Number
800370|NCT00955955|Secondary|The Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)|"This measure is a 16 item self report questionnaire assessing symptoms of depression. For each item, scores range from 0 to 3 with higher scores indicating greater impairment. To score this measure:
Enter the highest score from questions 1-4 (sleep items): ______
Enter score on item 5 ____
Enter the highest score from questions 6-9 (appetite/weight): ______
Enter score on item 10 ____
Enter score on item 11 ____
Enter score on item 12 ____
Enter score on item 13 ____
Enter score on item 14 ____
Enter the highest score from questions 15-16 (psychomotor items): ______
Total score range 0-27: ______
When assessing changes in this measure over time, negative means indicate an improvement (i.e. the scores decreased over time) and positive means indicate worsening in functioning."|Baseline and Day 60|Data presented is mean score reduction for the QIDS. The dataset of interest is limited to patients treated with placebo in phase I, did not experience a clinical response and entered phase II. Drug is compared to placebo in phase II for this subset alone.||Scores on a scale||Standard Deviation|Mean
800371|NCT00955955|Primary|The 17-item Hamilton Depression Scale (HAM-D-17)|"The HAM-D-17 is a multiple choice questionnaire that clinicians may use to rate the severity of a patient's major depression. Items are scored on a scale of zero to four and higher scores indicate greater impairment. This scale is scored by summing the scores on each item and scores can range from 0-68.
When assessing changes in HAMD score, negative changes indicate improvement (i.e. the score has decreased) and positive scores indicate a worsening of symptoms (i.e. scores have increased)."|Baseline and Day 60|The phase II dataset of interest is limited to patients treated with placebo in phase I, completed phase I, did not experience a clinical response and entered phase II. Drug is compared to placebo in phase II for this subset alone. Some patients received Deplin in both phases of the study, but those patients are not included in these analyses.||Scores on a scale||Standard Deviation|Mean
800372|NCT00956020|Primary|Qualitative Changes in Dermal and Sub Dermal Vascularity 12 Weeks After Treatment With Platelet Rich Fibrin Matrix|Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal vascularity (as determined by the number of specimen with greater than 5 immature capillaries per high powered field) after treatment with platelet rich fibrin matrix will be reported. Individual treated specimen were evaluated at 12 weeks after treatment, and the results used to determine the general qualitative changes and time frame for the effects of treatment.|12 weeks after treatment|Each participant underwent biopsy of skin treated with platelet rich fibrin matrix at 12 weeks.||% spec.with>5 immature capillaries/HPF|||Number
800373|NCT00956020|Primary|Qualitative Changes in Dermal and Sub Dermal Vascularity 10 Weeks After Treatment With Platelet Rich Fibrin Matrix|Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal vascularity (as determined by the number of specimen with greater than 5 immature capillaries per high powered field) after treatment with platelet rich fibrin matrix will be reported. Individual treated specimen were evaluated at 10 weeks after treatment, and the results used to determine the general qualitative changes and time frame for the effects of treatment.|10 weeks after treatment|Each participant underwent biopsy of skin treated with platelet rich fibrin matrix at 10 weeks.||% spec.with>5 immature capillaries/HPF|||Number
800374|NCT00956020|Primary|Qualitative Changes in Dermal and Sub Dermal Vascularity 6 Weeks After Treatment With Platelet Rich Fibrin Matrix|Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal vascularity (as determined by the number of specimen with greater than 5 immature capillaries per high powered field) after treatment with platelet rich fibrin matrix will be reported. Individual treated specimen were evaluated at 6 weeks after treatment, and the results used to determine the general qualitative changes and time frame for the effects of treatment.|6 weeks after treatment|Each participant underwent biopsy of skin treated with platelet rich fibrin matrix at 6 weeks.||% spec.with>5 immature capillaries/HPF|||Number
800375|NCT00956020|Primary|Qualitative Changes in Dermal and Sub Dermal Vascularity 2 Weeks After Treatment With Platelet Rich Fibrin Matrix|Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal vascularity (as determined by the number of specimen with greater than 5 immature capillaries per high powered field) after treatment with platelet rich fibrin matrix will be reported. Individual treated specimen were evaluated at 2 weeks after treatment, and the results used to determine the general qualitative changes and time frame for the effects of treatment.|2 weeks after treatment|Each participant underwent biopsy of skin treated with platelet rich fibrin matrix at 2 weeks.||% spec.with>5 immature capillaries/HPF|||Number
800376|NCT00956020|Primary|Qualitative Changes in Dermal and Sub Dermal Vascularity 1 Week After Treatment With Platelet Rich Fibrin Matrix|Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal vascularity (as determined by the the number of specimen with greater than 5 immature capillaries per high powered field) after treatment with platelet rich fibrin matrix will be reported. Individual treated specimen were evaluated at 1 week after treatment, and the results used to determine the general qualitative changes and time frame for the effects of treatment.|1 week after treatment|Each participant underwent biopsy of skin treated with platelet rich fibrin matrix at 1 week.||% spec.with>5 immature capillaries/HPF|||Number
800377|NCT00956020|Primary|Qualitative Changes in Dermal and Sub Dermal Vascularity 30 Minutes After Treatment With Platelet Rich Fibrin Matrix|Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal vascularity (as determined by the the number of specimen with greater than 5 immature capillaries per high powered field) after treatment with platelet rich fibrin matrix will be reported. Individual treated specimen were evaluated at 30 minutes after treatment, and the results used to determine the general qualitative changes and time frame for the effects of treatment.|30 minutes after treatment|Each participant underwent biopsy of skin treated with platelet rich fibrin matrix at 30 minutes.||% spec.with>5 immature capillaries/HPF|Participants||Number
800378|NCT00956020|Primary|Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 12 Weeks After Treatment With Platelet Rich Fibrin Matrix|Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal collagen (as determined by the number of specimen which had greater than 25% new collagen deposition per high powered field) 12 weeks after treatment with platelet rich fibrin matrix will be reported. The results were characterize the general qualitative changes and time frame for the effects of treatment.|12 weeks after treatment|Each participant will undergo biopsy of skin treated with platelet rich fibrin matrix, at 12 weeks after treatment.||%specimen with >25%new collagen/HPF|||Number
800379|NCT00956020|Primary|Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 10 Weeks After Treatment With Platelet Rich Fibrin Matrix|Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal collagen (as determined by the number of specimen which had greater than 25% new collagen deposition per high powered field) 10 weeks after treatment with platelet rich fibrin matrix will be reported. The results were characterize the general qualitative changes and time frame for the effects of treatment.|10 weeks after treatment|Each participant will undergo biopsy of skin treated with platelet rich fibrin matrix, at 10 weeks after treatment.||%specimen with >25%new collagen/HPF|||Number
800380|NCT00956020|Primary|Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 6 Weeks After Treatment With Platelet Rich Fibrin Matrix|Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal collagen (as determined by the number of specimen which had greater than 25% new collagen deposition per high powered field) 6 weeks after treatment with platelet rich fibrin matrix will be reported. The results were characterize the general qualitative changes and time frame for the effects of treatment.|6 weeks after treatment|Each participant will undergo biopsy of skin treated with platelet rich fibrin matrix, at 6 weeks after treatment.||%specimen with >25%new collagen/HPF|Participants||Number
800381|NCT00956020|Primary|Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 2 Weeks After Treatment With Platelet Rich Fibrin Matrix|Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal collagen (as determined by the number of specimen which had greater than 25% new collagen deposition per high powered field) 2 weeks after treatment with platelet rich fibrin matrix will be reported. The results were characterize the general qualitative changes and time frame for the effects of treatment.|2 weeks after treatment|Each participant will undergo biopsy of skin treated with platelet rich fibrin matrix, at 2 weeks after treatment.||%specimen with >25%new collagen/HPF|Participants||Number
800382|NCT00956020|Primary|Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 1 Week After Treatment With Platelet Rich Fibrin Matrix|Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal collagen (as determined by the number of specimen which had greater than 25% new collagen deposition per high powered field) 1 week after treatment with platelet rich fibrin matrix will be reported. The results were characterize the general qualitative changes and time frame for the effects of treatment.|1 week after treatment|Each participant will undergo biopsy of skin treated with platelet rich fibrin matrix, at 1 week after treatment.||%specimen with >25%new collagen/HPF|Participants||Number
800383|NCT00956020|Primary|Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 30 Minutes After Treatment With Platelet Rich Fibrin Matrix|Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal collagen (as determined by the number of specimen which had greater than 25% new collagen deposition per high powered field) 30 minutes after treatment with platelet rich fibrin matrix will be reported. The results were characterize the general qualitative changes and time frame for the effects of treatment.|30 minutes after treatment|Each participant will undergo biopsy of skin treated with platelet rich fibrin matrix, at 30 minutes after treatment.||%specimen with >25%new collagen/HPF|Participants||Number
800384|NCT00956085|Primary|Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale.|Patients given YBOCS (Yale Brown Obsessive-Compulsive Scale), a gold standard measure of obsessions and compulsions. For the YBOCS the minimum units are 0 and Maximum units on the total scale are 40. The higher the number on the YBOCS, the more severe the symptoms. Response was defined as at least a 35% reduction on the YBOCS.|Baseline and 6 weeks|||Participants|||Count of Participants
800385|NCT00956254|Secondary|AUC0-last of Fentanyl|AUC0-last is defined as the area under the plasma concentration-time curve from time-zero to the time of the last quantifiable concentration of fentanyl, was calculated using the linear trapezoidal rule, and was determined from individual concentration versus time data. Blood samples for pharmacokinetic analysis were drawn pre-dose; and 15 and 30 minutes; and 1, 2, 4, 6, 8, 10, and 12 hours post-dose. Fentanyl concentration assays were performed using a fully validated and sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. Results are reported for patients with and without mucositis.|Pre-dose to 12 hours post-dose|Pharmacokinetic evaluable population: All subjects who had evaluable plasma profiles to calculate reliable estimates of pharmacokinetic parameters and who had no major protocol deviations.||hr*ng/mL||Standard Deviation|Mean
800386|NCT00956254|Secondary|Tmax of Fentanyl|Tmax is defined as the time to reach the maximum concentration of fentanyl in plasma and was determined from individual concentration versus time data. Blood samples for pharmacokinetic analysis were drawn pre-dose; and 15 and 30 minutes; and 1, 2, 4, 6, 8, 10, and 12 hours post-dose. Fentanyl concentration assays were performed using a fully validated and sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. Results are reported for patients with and without mucositis.|Pre-dose to 12 hours post-dose|Pharmacokinetic (PK) population: All subjects who had evaluable plasma profiles to calculate reliable estimates of PK parameters and who had no major protocol deviations. One subject in the non-mucositis group self-administered a fentanyl product before receiving the study drug and was excluded from the PK population due to this protocol deviation.||hr||Standard Deviation|Mean
800387|NCT00956254|Primary|Cmax of Fentanyl|Cmax is defined as the maximum drug concentration in plasma and was determined from individual plasma concentration versus time data. Blood samples for pharmacokinetic analysis were drawn pre-dose; 15 and 30 minutes; and 1, 2, 4, 6, 8, 10, and 12 hours post-dose. Fentanyl concentration assays were performed using a fully validated and sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. Results are reported for patients with and without mucositis.|Pre-dose to 12 hours post-dose|Pharmacokinetic (PK) population: All subjects who had evaluable plasma profiles to calculate reliable estimates of PK parameters and who had no major protocol deviations. One subject in the non-mucositis group self-administered a fentanyl product before receiving the study drug and was excluded from the PK population due to this protocol deviation.||ng/mL||Standard Deviation|Mean
800388|NCT00956293|Secondary|Renal Function by Proteinuria||Months12, 24, 36, 48 and 60|This outcome measure was not analyzed because a total of 244 completed subjects were needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.|||||
800389|NCT00956293|Secondary|Renal Function by GFR Over Time||Months 12, 24, 36, 48 and 60|This outcome measure was not analyzed because a total of 244 completed subjects were needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.|||||
800390|NCT00956293|Secondary|Number of Participants Who Experienced Adverse Events, Serious Adverse Events and Death|Participants with adverse events (serious plus non-serious), serious adverse events and death were reported.|Months 6, 12, 24, 36, 48 and 60|Randomized Safety Set: This set included all randomized participants who received at least one dose of study medication.||Participants|||Number
800391|NCT00956293|Secondary|CD25 Saturation on Lymphocytes||Month 6|This outcome measure was not analyzed because a total of 244 completed subjects were needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.|||||
800392|NCT00956293|Secondary|Evolution of Renal Function (Creatinine Slope)|The study was terminated prematurely and not powered for efficacy.|Week 7, Month 6|This outcome measure was not analyzed because a total of 244 completed subjects were needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.|||||
800393|NCT00956293|Secondary|Occurrence of Treatment Failures|The study was terminated prematurely and not powered for efficacy.|Month 6|This outcome measure was not analyzed because a total of 244 completed subjects were needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.|||||
800394|NCT00956293|Secondary|Biopsy Proven Acute Rejection (BPAR), Graft Loss and Death|The study was terminated prematurely and not powered for efficacy.|Months 6, 12, 24, 36, 48 and 60|This outcome measure was not analyzed because a total of 244 completed subjects were needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.|||||
800395|NCT00956293|Secondary|Renal Function by Serum Creatinine|The study was terminated prematurely and not powered for efficacy.|Months 6, 12, 24, 36, 48 and 60|This outcome measure was not analyzed because a total of 244 completed subjects were needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.|||||
800396|NCT00956293|Secondary|Renal Function by GFR Via Modification of Diet in Renal Diseases (MDRD) and Nankivell Method|The study was terminated prematurely and not powered for efficacy.|Month 6|This outcome measure was not analyzed because a total of 244 completed subjects were needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.|||||
800397|NCT00956293|Primary|Renal Function by Glomerular Filtration Rate (GFR) Via Cockcroft-Gault Method|The study was terminated prematurely and not powered for efficacy.|Month 6|This outcome measure was not analyzed because a total of 244 completed subjects were needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.|||||
800398|NCT00956540|Primary|Weaning Time|The weaning time starts at the first disconnection from mechanical ventilation lasting >30 minutes and ends after the patient tolerate 24 consecutive hours disconnected from mechanical ventilation.|6 months|||day||Standard Deviation|Mean
800399|NCT00956540|Secondary|Tracheobronchitis and Pneumonia||6 months||||||
800400|NCT00956592|Secondary|Use of Adjuncts to Assist Intubation||1 year||||||
800401|NCT00956592|Secondary|Laryngeal View Achieved||1 year||||||
800402|NCT00956592|Secondary|Complications||1 year||||||
800403|NCT00956592|Secondary|Rescue Devices Used||1 year||||||
800404|NCT00956592|Secondary|Intubation Time|Time was measured as the duration of laryngoscopy defined by blade insertion to tracheal tube cuff inflation|1 year||||||
800405|NCT00956592|Primary|Measure of Intubation Success|Success was measured by confirmed tracheal tube placement with one attempt. Any removal of the laryngoscope blade constituted a failure|During each intubation in a 14 month period|4 patients of the 300 were excluded because the randomization was not followed due to unavailability of equipment or provider preference to remove patient from study||Participants||95% Confidence Interval|Number
800430|NCT00963807|Secondary|Overall Response Rate Reported as a Proportion of the Total Number of Patients Who Received at Least One Cycle of Therapy Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST)|RECIST version 1.1 was utilized for this outcome measure. A detailed description of RECIST 1.1 can be found here: Nishino M, Jackman DM, Hatabu H, Yeap BY, Cioffredi LA, Yap JT, et al. New Response Evaluation Criteria in Solid Tumors (RECIST) guidelines for advanced non-small cell lung cancer: comparison with original RECIST and impact on assessment of tumor response to targeted therapy. AJR Am J Roentgenol 2010;195:W221-8.|Up to 6 weeks|||percentage of participants|||Number
800431|NCT00963807|Secondary|Change in 18F-Fluorodeoxyglucose (FDG) Uptake|Will be calculated by subtracting the baseline FDG uptake from the post-cycle 2 uptake (as measured by SULmax).|Baseline and 6 weeks|||SULmax||Standard Deviation|Mean
800406|NCT00956631|Other Pre-specified|Quality of Life Physical Component Score (PCS) as Measured by the 12-question Short Form Survey Version 2 (SF-12v2). Change From Baseline Mean to Six Month Mean is Reported Below. A Positive Value Represents the 6 Month Value Minus the Baseline Value.|Minimally Important Difference (MID) is a measure of true clinical relevance of a difference. The MID for mean Physical Component Score (PCS) improvement is 2 to 3 points. SF-12v2 is a validated tool that uses norm-based scoring to determine treatment outcomes & is a generic measure, as opposed to one that targets a specific age, disease, or treatment group. The SF-12v2 asks for patient views about their health to determine how they feel & how well they are able to conduct their usual activities. The data for the 2 summary scales and 8 survey scales are normalized so each scale has the same mean (50 points) & the same standard deviation (10 points) in the general 1998 U.S. population. By using this method, anytime a scale is below 50, health status is below average, & each point is one-tenth of a standard deviation. The PCS summary measure takes into account the correlations among the Health Survey scales, & shows the broad impact which was of interest in this study.|Baseline and Six Months|All available participants were analyzed at six months.||units on a scale||95% Confidence Interval|Mean
800407|NCT00956631|Other Pre-specified|Function Measure Oswestry Disability Index (ODI). Measures Permanent Functional Disability Through Questions Which Characterize Disturbance of Activities of Daily Living (ADL) Resulting From Chronic Back Pain. Higher Scores Indicate Greater Disability.|Change from baseline to month six is reported below, where a positive value represents baseline value minus 6 month value. The questionnaire is divided into 10 topics including pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social life, traveling and employment/homemaking. Each topic is rated 0 (no pain or no limitation)to 5 (high pain or very limited physically) based on typical pain and/or physical limitations. The worst possible score is 50 (100 % disability) and best would be zero (0% disability).|Baseline and Six months|All available participants at Month 6.||units on a scale||95% Confidence Interval|Mean
800408|NCT00956631|Primary|Mean Change in Back Pain as Measured by a 10-point Visual Analog Scale (VAS).|The 10-point Visual Analog Scale rates 'no pain' as zero and 'worst pain imaginable' as ten. Visual analog scores of mean improvement greater than or equal to 2.0 are clinically relevant. The change from baseline to six months is reported below, where a positive value represents the baseline value minus the 6 month value.|Baseline and Six Months|All available treated patients at Month 6.||units on a scale||95% Confidence Interval|Mean
800409|NCT00956657|Primary|CR Adherence|Number of cardiac rehabilitation classes attended in total.|Approximately 3-months after recruitment|||Classes Attended||Standard Deviation|Mean
800410|NCT00956657|Secondary|Illness Perceptions Questionnaire-Revised Scores|Eight sub-scale scores obtained. Sub-scales include; Illness consequences, Illness Control, Treatment Control, Illness Identity, Emotional Representation, Illness Cause, Illness Coherence, Timeline Cyclical. Minimum and Maximum scores vary for each sub-scale.|3-months after consent||||||
800411|NCT00956709|Secondary|Duration of Sensory Sciatic Block (h)||72 hours|||hours||Full Range|Median
800412|NCT00956709|Secondary|Duration of Motor Sciatic Block (h)||72 hours|||hours||Full Range|Median
800413|NCT00956709|Secondary|Evaluate the Relative Position of the Tibial and Contigent Fibulaire Common in the Sciatic Nerve.||72 hours||||||
800414|NCT00956709|Primary|Compare the Onset of Action of Ropivacaine 0.5% and levobupivacaïne 0.5 % for Sciatic Nerve Block Guided in Major Surgery of the Foot||72 hours|Two patients in each group had incomplete block before surgery.||minutes||Full Range|Median
800415|NCT00956761|Primary|Number of Participants Who Reported Solicited Local and Systemic Reactions|Safety was assessed for participants who reported solicited local and systemic reactions from day 0 up to and including day 3 after the FLUAD vaccination.|0-3 days post-vaccination|Analysis was done using the safety dataset; participants in the exposed population who provided post-vaccination safety data.||Number of participants|||Number
800416|NCT00956761|Primary|Percentage of Participants Who Achieved SRH Area ≥25mm2 Against Each of the Three Vaccine Strains After One Vaccination of FLUAD|"Immunogenicity was measured as the percentage of participants achieving SRH area ≥25 mm2 against each of the three vaccine strains at baseline (day 0) and three weeks after FLUAD vaccination (day 21).
This criterion is met according to CHMP guideline if percentage of participants achieving SRH area ≥25 mm2 is 60% (≥65 years)."|day 21|Analysis was done using PP set.||Percentage of participants||95% Confidence Interval|Number
800417|NCT00956761|Primary|Geometric Mean Ratio of Participants Against Each of the Three Vaccine Strains After One Vaccination of FLUAD|"Geometric mean ratio (GMR) of participants was calculated as the ratio of post-vaccination to pre-vaccination SRH geometric mean areas (GMAs), directed against each of the three vaccine strains, three weeks after FLUAD vaccination (day 21).
The CHMP criterion was met if the geometric mean increase (GMR, day 21/day 0) in SRH antibody area is >2.0 (≥65 years)."|day 21|Analysis was done using PP set.||Ratio||95% Confidence Interval|Geometric Mean
800418|NCT00956761|Primary|Percentage of Participants Who Achieved Seroconversion or Significant Increase in Single Radial Hemolysis (SRH) Area Against Each of Three Vaccine Strains After One Vaccination of FLUAD|"Immunogenicity was measured as the percentage of participants who achieved seroconversion or significant increase in single radial hemolysis (SRH) area, against each of the three vaccine strains, three weeks after vaccination (day 21), evaluated using SRH assay.
Seroconversion: proportion of participants with negative pre-vaccination serum and a post-vaccination serum area ≥ 25 mm2. Significant increase: proportion of participants with at least a 50% increase in area from positive pre-vaccination serum. Seroconversion or significant increase: proportion of participants with either seroconversion or significant increase.
The European (Committee for Medicinal Products for Human Use [CHMP]) criterion is met, if percentage of participants achieving seroconversion or significant increase in SRH area is 30% (≥65 years)."|Day 21|Per protocol (PP) analysis set included all enrolled participants who had received the relevant dose of vaccine correctly on Day 0, provided evaluable serum samples with the relevant time windows, and had no major protocol violations.||Percentage of participants||95% Confidence Interval|Number
800432|NCT00963807|Primary|Change in FLT Uptake in Responders and Non-responders|Unadjusted analysis will be performed utilizing students t-tests. If the data appears non-normal, the Wilcox on rank-sum test will be used rather than the t-test. Adjusted analysis will be performed utilizing logistic regression.|Baseline and 6 weeks|||SULmax||Standard Deviation|Mean
800433|NCT00963807|Primary|Change in FLT Uptake|Will be calculated by subtracting the uptake of the scan after the second cycle of chemotherapy from the uptake of the pre-treatment scan.|Baseline and 6 weeks|||SULmax||Standard Deviation|Mean
800419|NCT00956813|Secondary|Change of Daily Interference as Measured by the Hot Flash Related Daily Interference Scale (HFRDIS)|The change of daily interference as measured by the HFRDIS from baseline to treatment termination between flaxseed versus placebo arms was evaluated with an independent t-test for continuous data. On a 0-10 scale, patients were asked to describe how hot flashes interfered with 10 different aspects of their life (work, social activities, leisure activities, sleep, mood, concentration, relationships with others, sexuality, enjoyment of life and overall quality of life). Scores were converted to a 0-100 scale where 100 is best QOL.The HFRDIS total score was the average of the 10 individual questions. The change in total score from baseline to end of treatment was analyzed between the groups using a Kruskal-Wallace test.|Baseline and up to 7 weeks|Per protocol, the study was powered for 77 patients on each arm. With 20% over-accrual, the analysis began after 94 patients registered to each arm. 25 patients from Flaxseed were not used (4 cancel, 2 ineligible, 12 refused further treatment, 5 due to adverse events, 2 noncompliance). 17 from the placebo arm were not used (3,1,5,7,1 respective)||units on a scale||Standard Deviation|Mean
800420|NCT00956813|Secondary|Change of Menopause Specific Quality of Life as Measured by the Menopause Specific Quality of Life (MENQOL)|The change in quality of life as measured by the MENQOL from baseline to treatment termination between flaxseed versus placebo arms was evaluated. On a 0-6 scale, patients were asked to answer questions in in each of 4 domain scores (Vasomotor, Psychosocial, Physical, Sexual) Scores were converted to a 0-100 scale where 100 is best QOL. The change in score from baseline to end of treatment were analyzed separately for each domain. Here we report the mean change in score for each category.|Baseline and up to 7 weeks|Per protocol, the study was powered for 77 patients on each arm. With 20% over-accrual, the analysis began after 94 patients registered to each arm. 25 patients from Flaxseed were not used (4 cancel, 2 ineligible, 12 refused further treatment, 5 due to adverse events, 2 noncompliance). 17 from the placebo arm were not used (3,1,5,7,1 respective)||units on a scale||Standard Deviation|Mean
800421|NCT00956813|Secondary|Change of Mood as Measured by the Profile of Mood States (POMS)|"Profile of Mood States (POMS) was used to look at total mood disturbance as well as the subscales of tension-anxiety, fatigue-inertia, and vigor-activity. The POMS is a well known, well validated, reliable measure of psychological distress which includes 6 subscales of fatigue-inertia, vigor-activity, tension-anxiety, depression-dejection, anger-hostility, and confusion-bewilderment. The entire scale can be scored to provide a measure of total mood disturbance. The measure contains adjectives related to mood which are scored from 0 (not at all) to 4 (extremely). Individual scores were converted to a 0-100 scale where 100 is best quality of life.
The change of mood as measured by the POMS from baseline to treatment termination between flaxseed versus placebo arms was compared using Kruskal-Wallis test. The mean change in total score for each arm is reported."|Baseline and up to 7 weeks|Per protocol, the study was powered for 77 patients on each arm. With 20% over-accrual, the analysis began after 94 patients registered to each arm. 25 patients from Flaxseed were not used (4 cancel, 2 ineligible, 12 refused further treatment, 5 due to adverse events, 2 noncompliance). 17 from the placebo arm were not used (3,1,5,7,1 respective)||units on a scale||Standard Deviation|Mean
800422|NCT00956813|Secondary|Toxicity as Measured by CTCAE v3.0|Frequency and severity of adverse events were reported by patients weekly evaluated through clinical assessment by NCI CTCAE v3.0. The number of patients reporting grade 3 or higher events are reported in this outcome measure. For a full list of all events, please refer to the Adverse Events section of this report.|Up to 7 weeks|All patients treated during the Double-blinded period of the study were included in this analysis||Participants|||Count of Participants
800423|NCT00956813|Primary|To Evaluate the Efficacy of Flaxseed on Hot Flash Scores in Women as Measured by a Daily Prospective Hot Flash Diary.|"The intra-patient difference in hot flash activity between baseline (study week 1) and treatment termination (study week 7) is the primary endpoint. The hot flash activity will be measured by the weekly average hot flash score which is a composite entity of both frequency and severity of hot flashes.
The hot flash severities are graded from 1 to 4, ranging from mild, to moderate, to severe to very severe. The daily hot flash score is computed by multiplying the mean grade of severity by the frequency during every 24 hour period. Therefore, a score of zero is the lowest possible score and can be interpreted as having no hot flashes. The average daily hot flash score during the baseline week was compared to the average daily value during week 7.
The primary method of analysis will be the independent sample t-test to examine the change of weekly average hot flash score from baseline to treatment termination between flaxseed and placebo arms."|Baseline and 7 weeks|Per protocol, the study was powered for 77 patients on each arm. With 20% over-accrual, the analysis began after 94 patients registered to each arm. 25 patients from Flaxseed were not used (4 cancel, 2 ineligible, 12 refused further treatment, 5 due to adverse events, 2 noncompliance). 17 from the placebo arm were not used (3,1,5,7,1 respective)||units on a scale||Standard Deviation|Mean
800424|NCT00956839|Secondary|Serum Total Calcium|Serum total calcium (mg/dL) at time points 0, 1, 3 and 6 months|0, 1, 3, 6 months post intervention|at time points 0, 1, 3 and 6 months||mg/dL||Standard Deviation|Mean
800425|NCT00956839|Primary|Percentage of Patients With Serum 25 Hydroxy Vitamin D3 > 30 ng/ml|Percentage of patients in each group with serum 25 hydroxy vitamin D >30 ng/ml|6 months post intervention|Intention to treat analysis||percentage of patients||95% Confidence Interval|Number
800426|NCT00963638|Primary|Frequency/Duration of Muscle Cramps||30 days||||||
800427|NCT00963638|Primary|Change in Frequency of Leg Cramps|Patients recorded number of leg cramps daily. The primary outcome measure was changed to the weekly average number of daily leg cramps for the first 28 days (4 weeks) after the start of treatment compared to the week prior to treatment (week 4 - pretreatment baseline).|30 days|||Cramps per week||Standard Deviation|Mean
800428|NCT00963677|Secondary|Time for Nasotracheal Intubation With the Use of Shikani Optical Stylet|The time of nasotracheal intubation was calculated from the SOS insertion to withdrawing the stylet from the endotracheal tube.|1 hour (peri-intubation time)|||seconds||Standard Deviation|Mean
800429|NCT00963677|Primary|Number of the Patients With Successful Nasotracheal Intubation|After anesthesia induction, the patients were undergone nasotracheal intubation with SOS. Number for first time successful intubation was recorded. If the time for one attempt intubation exceeded more than 120 seconds, it would be regarded as failed intubation for this time intubation. If a patient could not be successfully intubated after three attempts, the patients would be viewed as a case failing nasotracheal intubation with SOS.|1 hour(peri-intubation time)|||participants|||Number
800434|NCT00963807|Primary|Change in 18F-Fluorothymidine (FLT) Uptake|Will be calculated by subtracting the uptake of the scan after the first cycle of chemotherapy from the uptake of the pre-treatment scan.. Change in FLT uptake will be measured using the maximum standard uptake value adjusted for lean body mass (SULmax), which is a measure of how much radiotracer (in this case FLT) is being consumed by cells.|Baseline and 3 weeks|||SULmax||Standard Deviation|Mean
800435|NCT00963820|Primary|Neurotoxicity Grading|Neurotoxicity is graded using participant responses to 11 functional questions on a 5-point scale, where 0=Not at all and 4=Very much, using the Functional Assessment of Cancer Therapy/Gynecology Oncology Group - Neurotoxicity Questionnaire, Version 4.0(14). Neurotoxicity subscale is a sum of 11 reversed item scores where each original score is transformed as (4 - score). The highest possible score is 44, and a higher score indicates more neurotoxicity.|Cycle 1 Day 1 and End of Study (Up to 354 days)|Safety Population included all randomized participants who received study drug.||score on a scale||Standard Deviation|Mean
800436|NCT00963820|Secondary|Overall Response to Treatment With Ixazomib Citrate Based on Investigator's Evaluation Over Time|"Responses were based on International Myeloma Working Group Uniform Criteria. Complete Response (CR)=Negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow.
Partial Response (PR)= reduction in M-Protein ≥50% in serum and ≥90% in 24-hour urine. If M-protein unmeasurable, ≥50% decrease in difference of involved and uninvolved Free Light Chain (FLC). If M-protein and FLC unmeasurable, ≥50% reduction in plasma cells is required, if baseline bone marrow plasma cell ≥30%. And ≥50% reduction in the size of soft tissue plasmacytomas.
Minimal Response (MR)= 25–49% reduction in serum paraprotein for 6 weeks. 50–89% reduction in 24 hour urinary light chain excretion for 6 weeks. For Non-secretory myeloma patients, 25–49 % reduction in plasma cells in bone marrow and trephine biopsy for a 6 weeks. 25–49% reduction in the size of soft tissue plasmacytomas. No increase in the size or number of lytic bone lesions."|Up to 354 days|Response-Evaluable Population included all participants who had measurable disease at Baseline, had received at least 1 dose of study drug, and had at least 1 post-baseline response assessment.||percentage of participants||95% Confidence Interval|Number
800437|NCT00963820|Secondary|TEmax: Time of Occurrence of Emax||Days 1 and 15 of Cycle 1|PD analysis population included all participants who had sufficient dosing data to calculate PD parameters||Hours||Standard Deviation|Mean
800438|NCT00963820|Secondary|Emax: Maximum Inhibition|A Whole Blood 20S Proteasome Inhibition Parameter. There were no subjects in the Pharmacodynamic (PD) Analysis Set for the 2.23 mg/m^2 cohort, so PD tables do not include that arm.|Days 1 and 15 of Cycle 1|PD analysis Population included all participants who had sufficient dosing data to calculate PD parameters||Percentage of inhibition||Standard Deviation|Mean
800439|NCT00963820|Secondary|Terminal Phase Elimination Half-life (T1/2) for MLN2238|Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma. MLN2238 is the complete hydrolysis product of the study drug ixazomib citrate (MLN9708).|Day 15 of Cycle 1|Participants from the PK Analysis Population, all participants who had sufficient dosing data to calculate PK parameters, with data available for calculation of terminal phase elimination half-life.||hour||Standard Deviation|Mean
800440|NCT00963820|Secondary|Terminal Elimination Rate Constant (λz) for MLN2238|Terminal elimination rate constant (λz) is the rate at which drugs are eliminated from the body and the values were used for calculation of T1/2. MLN2238 is the complete hydrolysis product of the study drug ixazomib citrate (MLN9708).|Day 15 of Cycle 1|Participants from the PK Analysis Population, all participants who had sufficient dosing data to calculate PK parameters, with data available for calculation of terminal elimination rate constant.||1/hour||Standard Deviation|Mean
800441|NCT00963820|Secondary|Accumulation Ratio: Day 15 AUC0-168 / Day 1 AUC0-168 for MLN2238|MLN2238 is the complete hydrolysis product of the study drug ixazomib citrate (MLN9708).|Day 15 of Cycle 1|Participants from the PK Analysis Population, all participants who had sufficient dosing data to calculate PK parameters, with data available for calculation of accumulation ratio.||unitless||Standard Deviation|Mean
800442|NCT00963820|Secondary|AUC(0-168): Area Under the Plasma Concentration-Time Curve From Time 0 to 168 Hours Postdose for MLN2238|AUC(0-168) is a measure of the area under the plasma concentration-time curve over the dosing interval (tau) (AUC[0-tau]), where tau is the length of the dosing interval - 168 hours in this study). MLN2238 is the complete hydrolysis product of the study drug ixazomib citrate (MLN9708).|Days 1 and 15 of Cycle 1|Participants from the PK Analysis Population, all participants who had sufficient dosing data to calculate PK parameters, with data available for calculation of AUC(0-168).||hr*ng/mL||Standard Deviation|Mean
800443|NCT00963820|Secondary|Tmax: Time to Reach the Maximum Observed Plasma Concentration (Cmax) for MLN2238|Tmax: Time to reach the maximum observed plasma concentration (Cmax), equal to time to Cmax. MLN2238 is the complete hydrolysis product of the study drug ixazomib citrate (MLN9708).|Days 1 and 15 of Cycle 1|Participants from the PK Analysis Population, all participants who had sufficient dosing data to calculate PK parameters, with data available for analysis of Tmax.||hours||Full Range|Median
800444|NCT00963820|Secondary|Cmax: Maximum Observed Plasma Concentration for MLN2238|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. MLN2238 is the complete hydrolysis product of the study drug ixazomib citrate (MLN9708).|Days 1 and 15 of Cycle 1|Participants from the Pharmacokinetic (PK) Analysis Population, all participants who had sufficient dosing data to calculate PK parameters, with data available for calculation of Cmax.||ng/mL||Standard Deviation|Mean
800463|NCT00963872|Secondary|Non-Relapse Mortality|Deaths not due to relapse.|Day 180|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.||participants|||Number
800464|NCT00963872|Secondary|Incidence of Grades II-IV Graft-vs-host Disease|Development of graft-versus-host disease through day 100.|Day 0 through Day 100|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.||participants|||Number
800465|NCT00963872|Secondary|Donor Chimerism in Blood|Percentage of donor DNA present in the peripheral blood|Day 28|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.||percentage of donor DNA||Standard Deviation|Mean
800466|NCT00963872|Secondary|Neutrophil Engraftment|Achieving 500 neutrophils/uL by day 42.|Day 42|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.||participants|||Number
800445|NCT00963820|Primary|Number of Participants Reporting One or More Treatment-Emergent Adverse Events and Serious Adverse Events|"An Adverse Event is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
A Serious Adverse Event (SAE) was any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant."|From the first dose through 30 days after last dose of ixazomib citrate or until the start of subsequent antineoplastic therapy (Up to 354 days)|Safety Population included all randomized participants who received study drug.||participants|||Number
800446|NCT00963859|Primary|Overall Percentage Median Yield|The median yield (the lymph node count) allows for comparison of how many lymph nodes are left behind after robotic-assisted removal and are then found after a wider incision is made. Specifically a robot-assisted laparoscopic extended pelvic lymph node dissection (RA-PLND) is compared to a second-look open lymph node dissection (O-PLND) among participants undergoing radical cystectomy for urothelial carcinoma of the bladder. The median yield lymph nodes illustrates the adequacy of extended pelvic lymph node dissection using a robotic-assisted technique.|3 months including surgery and post-operative period.|||Percentage of Nodes (Node Yield)|||Number
800447|NCT00963859|Primary|Median Yield of Robot Assisted and Second Look Open Pelvic Lymph Node Dissection to Compare the Lymph Node Yield Achieved|The median yield (the lymph node count) allows for comparison of how many lymph nodes are left behind after robotic-assisted removal and are then found after a wider incision is made. Specifically a robot-assisted laparoscopic extended pelvic lymph node dissection (RA-PLND) is compared to a second-look open lymph node dissection (O-PLND) among participants undergoing radical cystectomy for urothelial carcinoma of the bladder. The median yield lymph nodes illustrate the adequacy of extended pelvic lymph node dissection using a robotic-assisted technique, i.e. whether the robotic-assisted laparoscopic radical cystectomy yields a sufficient number of lymph nodes to be oncologically equivalent to the open procedure.|3 months including surgery and post-operative period.|||Nodes (Node Yield)||Full Range|Median
800448|NCT00963872|Secondary|Donor Chimerism|Percentage of donor DNA in the bone marrow.|Day 360|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.||percentage of donor DNA||Standard Deviation|Mean
800449|NCT00963872|Secondary|Donor Chimerism|Percentage of donor DNA in the bone marrow.|Day 180|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.||percentage of donor DNA||Standard Deviation|Mean
800450|NCT00963872|Secondary|Donor Chimerism|Percentage of donor DNA in the bone marrow.|Day 100|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.||percentage of donor DNA||Standard Deviation|Mean
800451|NCT00963872|Secondary|Disease Progression|Patients who developed disease progression after transplantation.|Day 720|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.||participants|||Number
800452|NCT00963872|Secondary|Relapse of Disease|Patients who developed disease relapse after transplantation.|Day 720|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.||participants|||Number
800453|NCT00963872|Secondary|Overall Survival at Day 720|Survival (alive) from transplantation to last follow-up at day 720.|720 days|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.||participants|||Number
800454|NCT00963872|Secondary|Non-relapse Mortality|Deaths not due to relapse.|Day 360|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.||participants|||Number
800455|NCT00963872|Secondary|Incidence of Grades III-IV Graft-vs-host Disease|Development of graft-versus-host disease by day 100.|0 to 100 days|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.||participants|||Number
800456|NCT00963872|Secondary|Donor Chimerism in Blood|Percentage of donor DNA present in the peripheral blood|Day 60|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.||percentage of donor DNA||Standard Deviation|Mean
800457|NCT00963872|Secondary|Platelet Recovery|Number of patients with >20,000 platelets/uL by day 180|Day 180|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.||participants|||Number
800458|NCT00963872|Secondary|Disease Progression|Patients who developed disease progression after transplantation.|Day 360|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.||participants|||Number
800459|NCT00963872|Secondary|Relapse of Disease|Patients who developed disease relapse after transplantation.|Day 360|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.||participants|||Number
800460|NCT00963872|Secondary|Chronic Graft-Versus-Host Disease|Patients who developed chronic graft-versus-host disease.|Day 360|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.||participants|||Number
800461|NCT00963872|Secondary|Bone Marrow Chimerism|Percentage of donor DNA in the bone marrow.|Day 21|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.||percentage of donor DNA||Standard Deviation|Mean
800462|NCT00963872|Secondary|Overall Survival|Survival (alive) from transplantation to last follow-up.|Day 360|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.||participants|||Number
811706|NCT01059760|Primary|Change From Baseline in Participant Mean Corpuscular Hemoglobin Concentration (MCHC) When Fasting and Fed||Baseline and 3 days|||g/dL||Standard Deviation|Mean
800467|NCT00963872|Primary|Number of Patients With the Complement 3a (C3a) Unit Predominating|Efficacy of the pre-incubation of one of two umbilical cord blood (UCB) units with C3a as part of a unrelated donor double UCB nonmyeloablative transplantation in patients with high-risk hematological malignancies.|Day 180|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.||participants|||Number
800468|NCT00963924|Secondary|Side Effects Checklist (SEC)||Weeks 0 - 8, and Month 6 after cognitive remediation completion||||||
800469|NCT00963924|Secondary|Clinical Global Impression (CGI)||Weeks 0 and 8, and Month 6 after cognitive remediation completion||||||
800470|NCT00963924|Secondary|Calgary Depression Scale for Schizophrenia (CDSS)|Baseline scores on the Calgary Depression Scale for Schizophrenia (CDSS). Total CDSS scores range from 0-27. The assessment is comprised of 9 questions covering the topics of Depression, Hopelessness, Self Depreciation, Guilty Ideas of Reference, Pathological Guilt, Morning Depression, Early Wakening, Suicide, Observed Depression. Each item is scored on a scale from 0-3 (0 = absent, 1 = mild, 2 = moderate, 3 = severe). The total score is computed by adding up the individual scores of each item. The higher the score, the more prominent the symptoms of depression are for the participant.|Baseline|||units on a scale||Standard Deviation|Mean
800471|NCT00963924|Secondary|Heinrich Quality of Life Scale (QoL)|Baseline scores of the Heinrich Quality of Life Scale, a 21 item scale designed and validated to measure intrapsychic foundations, interpersonal relations, instrumental role, and common objects and activities in patients diagnosed with Schizophrenia. Patients are rated on each of the 21 items on a scale of 0-6. Total scores are computed by adding up the scores of each individual item, with a total score ranging from 0-126. Higher scores reflect higher functioning.|Baseline|||units on a scale||Standard Deviation|Mean
800472|NCT00963924|Secondary|Global Assessment of Functioning Scale (GAS)|The Global Assessment of Functioning Scale (GAS) measured at baseline. This scale measures social, occupational, and psychological functioning, on a scale of 0-100. The higher the score, the greater a participant's functioning level.|Baseline|||units on a scale||Standard Deviation|Mean
800473|NCT00963924|Secondary|Scale for Assessment of Negative Symptoms (SANS)|The total scores from baseline and week 8 on the scale for the assessment of negative symptoms (SANS) total score. Total SANS scores range from 0-100. The SANS is comprised of 5 subscores: Affective Flattening or Blunting (score range 0-35), Alogia (score range 0-20), Avolition-Apathy (score range 0-15), Anhedonia-Asociality (score range 0-20), and Attention (0-10). For each scale, the higher the score the more prominent the negative symptoms were. The total score was computed by adding all the sub-scale total scores. Scores are reported for baseline and week 8.|Baseline vs. Week 8|||units on a scale||Standard Deviation|Mean
800474|NCT00963924|Secondary|Positive and Negative Syndrome Scale (PANSS)|The baseline score on the positive symptom sub-scale of the Positive and Negative Syndrome Scale (PANSS). Total PANSS positive symptom sub-scale scores range from 7-49. The PANSS positive symptom sub-scale is comprised of 7 items rated on a scale of 1-7: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. A score of one on each item 1 absent, 2 is minimal, 3 is mild, 4 is moderate, 5 is moderately severe, 6 is severe, and 7 is extreme. The total score was computed by adding all the items on the sub-scale together. The higher a score the more prominent a positive symptom is.|Baseline|||units on a scale||Standard Deviation|Mean
800475|NCT00963924|Primary|Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS)|Change of a composite score from baseline to week 8 on the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS). The MATRICS consists of 10 cognitive tasks that are used to calculate scores in 7 cognitive domains: speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The raw scores on each cognitive task are transformed into t-scores, and then these scores are used to calculate the domain scores. The composite score is calculated by averaging all domain t-scores to come up with one overall cognitive composite t-score. For all scores on the assessment, the higher the score the better the performance on the task.|Baseline vs. Week 8|||Units on a scale||Standard Deviation|Mean
800476|NCT00963937|Secondary|Percentage of Participants Who Used Rescue Medication Between the Time of Dosing and 240 Minutes Post-Treatment|Rescue medication included one of the following: a single oral dose of a nonsteroidal anti-inflammatory drug (NSAID) or acetaminophen, not to exceed the maximum recommended single dose; and anti-emetics (a drug to prevent vomiting).|within 240 minutes post-treatment (Randomization through Final Visit [Week 6])|FAS. The analysis was performed on the observed case dataset, a dataset without any imputation of missing data.||percentage of participants|||Number
800477|NCT00963937|Secondary|Percentage of Participants Who Were Free of Vomiting at 30, 60, 120, and 240 Minutes Post-Treatment|"Vomiting is one of the associated symptoms of a migraine. A participant was assessed as being free of vomiting when the symptom was recorded as absent at each time point in his or her patient diary. Vomiting was recorded as present for all subsequent assessments if a participant took a rescue medication."|30, 60, 120, and 240 minutes post-treatment (Randomization through Final Visit [Week 6])|FAS. The analysis was performed on the LOCF dataset. Only participants who had vomiting at the time of treatment were included in the denominator.||percentage of participants|||Number
800478|NCT00963937|Secondary|Percentage of Participants Who Were Nausea Free at 30, 60, 120, and 240 Minutes Post-Treatment|"Nausea is one of the associated symptoms of a migraine. A participant was assessed as nausea free when the symptom was recorded as absent at each time point in his or her patient diary. Nausea was recorded as present for all subsequent assessments if a participant took rescue medication."|30, 60, 120, and 240 minutes post-treatment (Randomization through Final Visit [Week 6])|FAS. The analysis was performed on the LOCF dataset. Only participants who had nausea at the time of treatment were included in the denominator.||percentage of participants|||Number
800479|NCT00963937|Secondary|Percentage of Participants Who Were Phonophobia Free at 30, 60, 120, and 240 Minutes Post-Treatment|"Phonophobia (sensitivity to sound) is one of the associated symptoms of a migraine. A participant was assessed as phonophobia free when the symptom was recorded as absent at each time point in his or her patient diary. Phonophobia was recorded as present for all subsequent assessments if a participant took rescue medication."|30, 60, 120, and 240 minutes post-treatment (Randomization through Final Visit [Week 6])|FAS. The analysis was performed on the LOCF dataset. Only participants who had phonophobia at the time of treatment were included in the denominator.||percentage of participants|||Number
800480|NCT00963937|Secondary|Percentage of Participants Who Were Photophobia Free at 30, 60, 120, and 240 Minutes Post-Treatment|"Photophobia (sensitivity to light) is one of the associated symptoms of a migraine. A participant was assessed as photophobia free when the symptom was recorded as absent at each time point in his or her patient diary. Photophobia was recorded as present for all subsequent assessments if a participant took rescue medication."|30, 60, 120, and 240 minutes post-treatment (Randomization through Final Visit [Week 6])|FAS. The analysis was performed on the LOCF dataset. Only participants who had photophobia at the time of treatment were included in the denominator.||percentage of participants|||Number
800481|NCT00963937|Secondary|Percentage of Participants Who Were Pain Free at 30, 60, 120, and 240 Minutes Post-Treatment|Pain free was defined as a post-treatment pain intensity score of 1 on a 5-grade scale in participants who had not used headache rescue medication before assessment. A pain intensity score of 5 was assigned for all subsequent assessments if a participant took a rescue medication. The 5-grade scale is a participant's self-rating scale to assess the pain intensity of a migraine with the following scores: 1 = none, 2 =mild, 3=mild to moderate, 4=moderate to severe, and 5=severe.|30, 60, 120, and 240 minutes post-treatment (Randomization through Final Visit [Week 6])|FAS. The analysis was performed on the LOCF dataset.||percentage of participants|||Number
800482|NCT00963937|Secondary|Percentage of Participants Who Reported Pain Relief at 30, 60, 120, and 240 Minutes Post-Treatment|Pain relief was defined as at least a 2-grade reduction in pain intensity on a 5-grade scale in participants who had not used headache rescue medication before assessment. A pain intensity score of 5 was assigned for all subsequent assessments if a participant took rescue medication (a single oral dose for the treatment of migraine pain or associated symptoms). The 5-grade scale is a participant's self-rating scale to assess the pain intensity of a migraine with the following scores: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe.|30, 60, 120, and 240 minutes post-treatment (Randomization through Final Visit [Week 6])|FAS. The analysis was performed on the LOCF dataset.||percentage of participants|||Number
800483|NCT00963937|Primary|Percentage of Participants Who Reported Pain Relief at 120 Minutes Post-Treatment|Pain relief was defined as at least a 2-grade reduction in pain intensity on a 5-grade scale in participants who had not used headache rescue medication before assessment. A pain intensity score of 5 was assigned for all subsequent assessments if a participant took rescue medication (a single oral dose for the treatment of migraine pain or associated symptoms). The 5-grade scale is a participant's self-rating scale to assess the pain intensity of a migraine with the following scores: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe.|120 minutes post-treatment (Randomization through Final Visit [Week 6])|Full Analysis Set (FAS): all participants in the Safety Population (all participants who took >=1 dose of investigational product [IP]) who provided any post-treatment efficacy assessment. Analysis was performed on the last observation carried forward (LOCF) dataset (imputed by LOCF method). Only post-treatment values were used for imputation.||percentage of participants|||Number
800484|NCT00964444|Primary|Force Exerted on a Fetus as the Delivery Occurs|The amount of force exerted on the fetus was measured in ounces. It was calculated based on measurements from the force transducers in the platform. The obstetrician stands or sits on the platform as the infant is delivered.|Assessment was done after the delivery|||ounces||Standard Deviation|Mean
800485|NCT00964496|Primary|Cessation of Bleeding|The cessation of bleeding was defined as repeated negative faecal occult blood test (FOBT) (monoclonal colloidal gold color technology) during our observation period. Rebleeding was defined based on a positive FOBT at any visit after treatment.|52 months|||participants|||Number
800486|NCT00964496|Secondary|Change From Baseline in Total Transfused Red Cell Requirements at 12 Months|Change of total transfused red cell requirements at 12 months after randomization from one year before baseline in transfusion dependent patients|baseline and 12 months|There are 14 participants depended on blood transfusion in each group||milliliter||Standard Deviation|Mean
800487|NCT00964496|Secondary|Participants Dependent on Blood Transfusions|Numbers of participants dependent on blood transfusions|52 months|55 patients were enrolled in our study. One in iron-controlled group refused to continue for personal reason after 8 months, two other in thalidomide plus iron group refused to take study medications after 4 weeks treatment due to leukopenia and unexplained somnolence. Analysis was performed according to Intention-to-Treat principle.||participants|||Number
800488|NCT00964496|Secondary|Change From Baseline in Bleeding Duration at 12 Months|The change from baseline in bleeding duration at 12 months|baseline and 12 months|||days||Standard Deviation|Mean
800489|NCT00964496|Secondary|Change From Baseline in Bleeding Episodes at 12 Months|The Change from baseline in bleeding episodes at 12 months|baseline and 12 months|||bleeding episodes||Standard Deviation|Mean
800490|NCT00964496|Secondary|Change From Baseline in Hemoglobin (Hb) Level at 12 Months|The change from baseline in average hemoglobin (Hb) level(tested every month) at 12 months.|baseline and 12 months|||g/L||Standard Deviation|Mean
800491|NCT00964496|Primary|Participants Whose Rebleeds Decreased From Baseline by ≥ 50% at 12 Months|The primary end point was defined as the patients whose rebleeds decreased from baseline by ≥ 50% at 12 months. Reduction of rebleeds = [(total bleeding episode at 12 months - total bleeding episodes at a year before randomization)/total bleeding episodes at a year before randomization(baseline)]*100%. Rebleeding was defined based on a positive fecal occult blood test (FOBT) (monoclonal colloidal gold color technology) at any visit after treatment.|baseline and 12 months|||participants|||Number
800492|NCT00964548|Secondary|Transcranial Doppler Mean Flow Velocity (Change From Baseline Mean Flow Velocity (Pre-infusion) Over Time Until 135 Minutes Post-infusion)|Mean flow velocities of vessel in vasospasm (Change from baseline mean flow velocity (pre-infusion) over time until 135 minutes post-infusion).|baseline until 135 minutes post-infusion|||cm/s||95% Confidence Interval|Mean
800493|NCT00964548|Secondary|Transcranial Doppler Peak Systolic Velocity (Change From Baseline Peak Systolic Velocity (Pre-infusion) Over Time Until 135 Minutes Post-infusion)|Peak Systolic Velocity of vessel in vasospasm (Change from baseline peak systolic velocity (pre-infusion) over time until 135 minutes post-infusion).|baseline until 135 minutes post-infusion|||cm/s||95% Confidence Interval|Mean
800494|NCT00964548|Primary|Hemodynamic Parameters (Change From Baseline Systolic Blood Pressure (Pre-infusion) Over Time Until 135 Minutes Post-infusion)|Systolic Blood Pressure (Change from baseline systolic blood pressure (pre-infusion) over time until 135 minutes post-infusion).|baseline until 135 minutes post-infusion|||mmHg||95% Confidence Interval|Mean
800495|NCT00964678|Secondary|Change in Tricuspid Annular Plane Systolic Excursion|Higher values indicate a better outcome.|baseline and 6 months|The patient excluded from the analysis was unable to be present for the final echo-cardiogram due to lack of transportation and distance from the hospital. Multiple attempts to schedule the study test were made through phone and email.||centimeters|||Number
800496|NCT00964678|Secondary|Change in 6 Minute Walk Distance||baseline and 6 months|The patient who was excluded from analysis developed an orthopedic injury during the study and was unable to complete the walking test at conclusion of the study||feet|||Number
800497|NCT00964678|Secondary|Change in Right Ventricular End Systolic Volume|right ventricular end systolic volume determined by MRI|baseline and 6 months|||mL|||Number
800498|NCT00964678|Primary|Absolute Change in Right Ventricular Ejection Fraction|Change in right ventricular ejection fraction is measured by cardiac magnetic resonance imaging, using the method of disks with the reading radiologist being blinded to before and after images. Cardiac magnetic resonance imaging was done at baseline and 6 months only|baseline, 6 months|Patients with right heart catheterization confirmed pulmonary arterial hypertension, already on pulmonary vasodilator therapy||% RVEF||95% Confidence Interval|Mean
800499|NCT00964743|Secondary|CSF and Serum Vascular Endothelial Growth Factor (VEGF) Levels|CSF and serum VEGF levels were to be measured over time, and the means and standard errors of the respective VEGF levels were to be plotted at specific sampling time points. The respective VEGF levels may also have been correlated with patients’ PFS, OS, or cytology using descriptive statistical methods similarly as mentioned above. The log transformation of lab values were to be employed on the continuous variables whenever necessary.|6 Months|The study closed early due to low accrual of 2 of 10 expected patients. Neither patient completed 8 weeks of treatment as outlined in the protocol. Both patients expired before reaching the 6 month Progression Free Survival endpoint.|||||
800500|NCT00964743|Secondary|Sorafenib Levels in Cerebrospinal Fluid (CSF)|CSF sorafenib level was to be measured over time, and the means and standard errors of the sorafenib level were to be plotted at specific sampling time points. CSF sorafenib levels may also have been correlated with patients’ PFS, OS, or cytology using descriptive statistical methods (e.g., KM analysis stratified by high vs. low CSF sorafenib levels). The log transformation of lab values were to be employed on the continuous variables whenever necessary.|6 Months|The study closed early due to low accrual of 2 of 10 expected patients. Neither patient completed 8 weeks of treatment as outlined in the protocol. Both patients expired before reaching the 6 month Progression Free Survival endpoint.|||||
800501|NCT00964743|Secondary|Number of Participants With Overall Survival (OS)|Several secondary endpoints were to be analyzed in a descriptive fashion. All patients were to be followed up until death.|6 Months|The study closed early due to low accrual of 2 of 10 expected patients. Neither patient completed 8 weeks of treatment as outlined in the protocol. Both patients expired before reaching the 6 month Progression Free Survival endpoint.|||||
800502|NCT00964743|Secondary|Number of Participants With Progression Free Survival (PFS) at 6 Months|Kaplan-Meier analysis of PFS was to be performed and the PFS at 6 months in the study patients were be empirically described. All patients were to be followed up until death.|6 Months|The study closed early due to low accrual of 2 of 10 expected patients. Neither patient completed 8 weeks of treatment as outlined in the protocol. Both patients expired before reaching the 6 month Progression Free Survival endpoint.|||||
800503|NCT00964743|Primary|Number of Participants With Adverse Events (AEs)|Safety and tolerability of sorafenib with DepoCyt. Toxicities were to be reported using tables and descriptive statistics by type and grade. All patients were to be followed up until death.|6 Months|All participants||participants|||Number
800504|NCT00964795|Other Pre-specified|Summary of Study Duration (Weeks)|Study Duration = (last visit/ discontinuation date - first dose date + 28)/7|Baseline through end of treatment (Week 180)|||weeks||Standard Deviation|Mean
800505|NCT00964795|Other Pre-specified|Summary of Treatment Duration (Weeks)|Treatment Duration = (last dose date - first dose date + 28)/7|Baseline through end of treatment (Week 180)|||weeks||Standard Deviation|Mean
800506|NCT00964795|Secondary|Change in BCVA Letter Score (mLOCF)|"The secondary endpoint in the study is the change in BCVA letter score from baseline through Week 116.
(mLOCF: The last non-missing observation prior to the missing visit was carried forward to impute the missing data; no imputation after last visit; no baseline value carried forward)."|Baseline through Week 116|||letters correctly read||Standard Deviation|Mean
800507|NCT00964795|Primary|Safety and Tolerability of Intravitreal Aflibercept Injection in Participants With Neovascular AMD|"The primary endpoint in the study is the safety and tolerability of Intravitreal Aflibercept Injection in patients with neovascular AMD (Age-related Macular Degeneration) from day 1 through the end of treatment visit (week 180) based on the number of participants who experienced any treatment-emergent adverse event (TEAE).
Treatment-emergent adverse events were categorized according to Ocular TEAEs in the study eye, Ocular TEAEs in the fellow eye, and Non-Ocular TEAEs"|Baseline (day 1) through end of treatment (Week 180)|||participants|||Number
800508|NCT00964860|Secondary|Whole Mouth Mean Lobene Modified Gingival Index Between the Brushing Only Group and the Brushing + Flossing Group|"Whole-mouth average MGI scores were calculated separately for each subject and visit by averaging the MGI scores of all gradable sites. Interpoximal average MGI scores were also calculated for each subject and visit by averaging over only interpoximal sites (buccal-mesial, buccal-distal, lingual-mesian, and lingual-distal).
Within each treatment, changes from baseline were analyzed using paired t-test. Between treatments mean comparisons were conducted using analysis of covariance with baseline MGI score as a covariate. All statistical comparisons were two-sided with a 5% significance level.
The average MGI score for a subject can range from 0 (no gingivitis) to 4 (inflammation on all gradable sites)."|30 days|per protocol||units on a scale||Standard Error|Least Squares Mean
800509|NCT00964860|Primary|Mean Interproximal Lobene Modified Gingival Index Between the Brushing Only Group and the Brushing + Flossing Group|Gingivitis was scored using the Lobene Modified Gingival Index (a visual examination for inflammation) on all scorable teeth. For each tooth, six gingival areas (distobuccal, buccal, mesiobuccal, mesiolingual, lingual, and distolingual) were scored on a 5-point, categorical scale (0 = absence of inflammation; 4 = severe inflammation) corresponding to Inflammation|30 days|per protocol||units on a scale||Standard Error|Mean
801150|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment|Subject response to the following question: If you were to choose to continue treatment for your acne, which treatment would you choose? (Yes or No).|Week 1, Week 2|ITT||Participants|||Number
800510|NCT00964886|Secondary|Roland and Morris Disability Questionnaire|"This questionnaire measures disability in everyday function due to back pain. It is a 24-item checklist asking patients to endorse whether or not back pain limits activities they normally do (eg, I stay at home most of the time because of my back). Scores range from 0 to 24, with higher scores indicating greater disability in everyday function due to back pain. The analysis evaluated the 'as randomized' sample at 12 weeks after baseline, after co-varying for baseline (pre-treatment) values."|12 weeks after baseline (or last observation carried forward)|All participants assigned at baseline to receive cognitive behavioral therapy or to no cognitive behavioral therapy (behavioral effect). This is an 'as randomized' Intent-to-Treat analysis. Values are mean scores at Week 12 (or last observation carried forward). Means are adjusted for baseline Roland and Morris scores||Units on a scale.||Standard Error|Mean
800511|NCT00964886|Primary|Intent-toTreat Analysis of Descriptor Differential Scale (DDS) of Pain Intensity|"The DDS is self-report measure of current pain intensity of chronic back pain. Participants rate pain on a 20 point scale as being greater or less intense relative to 12 adjectival descriptor words which serve as anchors (eg, greater or less than faint, moderate, strong). Scores range from 0 to 20 with higher scores indicating higher pain intensity. The analysis evaluated the 'as randomized' sample at 12 weeks after baseline or last observation carried forward, after co-varying for baseline (pre-treatment) values."|12 weeks after baseline (or last observation carried forward)|We conducted an intent-to-treat analysis of all randomized participants assigned to cognitive behavioral therapy to or no behavior therapy comparing mean DDS pain intensity at Week 12 (or the last observation carried forward) adjusted for mean baseline score.||units on a scale||Standard Error|Mean
800512|NCT00964886|Secondary|Roland and Morris Disability Questionnaire|"This questionnaire measures disability in everyday function due to back pain. It is a 24-item checklist asking patients to endorse whether or not back pain limits activities they normally do (eg, I stay at home most of the time because of my back). Scores range from 0 to 24, with higher scores indicating greater disability in everyday function due to back pain. The analysis evaluated the 'as randomized' sample at 12 weeks after baseline, after co-varying for baseline (pre-treatment) values."|12 weeks after baseline (or last observation carried forward)|All participants assigned at baseline to receive desipramine hydrochloride or benztropine mesylate (drug effect). This is an 'as randomized' Intent-to-Treat analysis. Values are mean scores at Week 12 (or last observation carried forward). Means are adjusted for baseline Roland and Morris scores||Units on a scale.||Standard Error|Mean
800513|NCT00964886|Primary|Intent-toTreat Analysis of Descriptor Differential Scale (DDS) of Pain Intensity|"The DDS is self-report measure of current pain intensity of chronic back pain. Participants rate pain on a 20 point scale as being greater or less intense relative to 12 adjectival descriptor words which serve as anchors (eg, greater or less than faint, moderate, strong). Scores range from 0 to 20 with higher scores indicating higher pain intensity. The analysis evaluated the 'as randomized' sample at 12 weeks after baseline or last observation carried forward, after co-varying for baseline (pre-treatment) values."|12 weeks after baseline (or last observation carried forward)|We conducted an intent-to-treat analysis of all randomized participants assigned to desipramine or to active drug placebo (benztropine) comparing mean DDS pain intensity at Week 12 (or the last observation carried forward) adjusted for mean baseline score.||units on a scale||Standard Error|Mean
800514|NCT00965081|Secondary|Number of Participants With Suicidal Behaviors and Ideations Collected by Columbia -Suicide Severity Rating Scale (C-SSRS)|"The C-SSRS is a scale capturing occurrence, severity, and frequency of suicide-related thoughts and behaviors. The number of participants with suicidal behaviors and ideations are provided.
Suicidal behavior: a “yes” answer to any of 5 suicidal behavior questions which include: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide.
Suicidal ideation: a “yes” answer to any 1 of 5 suicidal ideation questions which include wish to be dead and 4 different categories of active suicidal ideation."|Baseline through 12 weeks|Only participants having at least 1 post-baseline C-SSRS assessment were included in this analysis.||Participants|||Number
800515|NCT00965081|Secondary|Change From Baseline to 12-Week Endpoint 36-Item Short-Form Health Survey (SF-36)|SF-36 has 36 items with 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional, general health; each scored on 0 to 100 scale. Higher scores indicate better status. Mental component summary (MCS) and physical component summary (PCS) based on 8 SF-36 domains. Scales scored using norm-based methods; mean is 50 and standard deviation is 10 in U.S. population. Treatment group difference in Least Squares (LS) Means at endpoint from analysis of covariance. Terms for treatment group, pooled investigators, baseline in model.|Baseline, 12 weeks|Intention to treat (ITT) population: analyses conducted per initial group assignments. The last-observation-carried-forward (LOCF) method used to impute the missing endpoint.||Units on a scale||Standard Error|Least Squares Mean
800516|NCT00965081|Secondary|Change From Baseline to 12-Week Endpoint Beck Anxiety Inventory (BAI)|"The BAI is a 21-item patient-completed questionnaire designed to assess the characteristics of anxiety. Each item is rated on a 4-point scale (0=not present; 3=present in the extreme). The total score ranges from 0 to 63; the higher the score, the more severe the anxiety symptoms.
The treatment group difference in the Least Squares (LS) Means at endpoint is from an analysis of covariance (ANCOVA). The model included terms for treatment group, pooled investigators and baseline."|Baseline, 12 weeks|Intention to treat (ITT) population: analyses conducted per initial group assignments. The last-observation-carried-forward (LOCF) method used to impute the missing endpoint during initial double-blind therapy.||Units on a scale||Standard Error|Least Squares Mean
800517|NCT00965081|Secondary|Change From Baseline to 12-Week Endpoint Fibromyalgia Impact Questionnaire (FIQ)|FIQ is a 20-item self-administered questionnaire that measures fibromyalgia (FM) patient status, progress, and outcomes over the past week. The total score ranges from 0 to 80 with higher scores reflecting a more negative impact of FM. The treatment group difference in the Least Squares (LS) Means change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included terms for treatment group, pooled investigators and baseline.|Baseline, 12 weeks|Intention to treat (ITT) population: analyses conducted per randomly assigned groups. Baseline-observation-carried-forward (BOCF) method used to impute endpoint value for those who discontinued initial double-blind therapy(DB) due to adverse event; last non-missing observation during initial DB used to impute the missing endpoint for all others.||Units on a scale||Standard Error|Least Squares Mean
807034|NCT01018511|Secondary|Cminss of Solifenacin||Week 4, Week 8 and Week 12|"PKAS population. N indicates the number of participants with available data at each timepoint."||ng/mL||Geometric Coefficient of Variation|Geometric Mean
800518|NCT00965081|Secondary|Change From Baseline to 12-Week Endpoint Beck Depression Inventory-II (BDI-II)|The BDI-II is a 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a 4-point scale for each item ranging from 0 to 3 (0 = not present; 3 = present in the extreme). The treatment group difference in the Least Squares (LS) Means change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included terms for treatment group, pooled investigators and baseline.|Baseline, 12 weeks|Intention to treat (ITT) population: analyses conducted per initial group assignments. The last-observation-carried-forward (LOCF) method was used to impute the missing endpoint during initial double-blind therapy.||Units on a scale||Standard Error|Least Squares Mean
800519|NCT00965081|Secondary|Clinical Global Impression of Improvement (CGI-I) for Depression at Endpoint|"The CGI-I measures clinician's perception of patient improvement at time of assessment compared with start of treatment. Scores range from 1 (very much improved) to 7 (very much worse).
The treatment group difference in Least Squares (LS) Means at endpoint is from an analysis of covariance (ANCOVA). The model included terms for treatment group, pooled investigators and baseline CGI-Severity (CGI-S)."|12 weeks|Intention to treat (ITT) population: analyses conducted per initial group assignments. The last-observation-carried-forward (LOCF) method was used to impute the missing endpoint during initial double-blind therapy.||Units on a scale||Standard Error|Least Squares Mean
800520|NCT00965081|Secondary|Patient Global Impression - Improvement (PGI-I) at Endpoint|"The PGI-I scale is a patient-rated instrument that measures perceived improvement in symptoms. It is a 7-point scale: score of 1 is very much better, 4 is no change, and 7 is very much worse. Treatment group difference in Least Squares (LS) Means at endpoint is from an analysis of covariance (ANCOVA); model included terms for treatment group, pooled investigators and baseline PGI-Severity (PGI-S)."|12 weeks|Intention to treat (ITT) population: analyses conducted per initial group assignments. The last-observation-carried-forward (LOCF) method was used to impute the missing endpoint during initial double-blind therapy.||Units on a scale||Standard Error|Least Squares Mean
800521|NCT00965081|Secondary|Change From Baseline to 12-Week Endpoint in the Brief Pain Inventory (BPI) - Modified Short Form|BPI-Modified Short Form mean interference score ranges from 0 (does not interfere) to 10 (completely interferes) for pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Treatment group difference in the Least Squares (LS) Means changes from baseline to endpoint is from an analysis of covariance (ANCOVA) with terms for treatment group, pooled investigators and baseline. Last-observation-carried forward (LOCF) endpoint defined as last available post-baseline value obtained during initial double-blind therapy.|Baseline, 12 weeks|Intention to treat (ITT) population: analyses conducted per initial group assignments. The LOCF method was used to impute the missing endpoint during initial double-blind therapy.||Units on a scale||Standard Error|Least Squares Mean
800522|NCT00965081|Primary|"Change From Baseline to 12-Week Endpoint in the Brief Pain Inventory (BPI) 24-Hour Average Pain Item (Question 3) of the BPI-Modified Short Form Score"|BPI Average Pain score ranges from 0 (no pain) to 10 (pain as bad as you can imagine). Treatment group difference in Least Squares (LS) Means changes from analysis of covariance (ANCOVA) with terms for treatment group, pooled investigators, baseline. Baseline-observation-carried-forward (BOCF) method used to impute endpoint value for those who discontinued initial double-blind therapy (DBT) due to adverse event (AE); last non-missing observation during initial DBT used to impute missing endpoint for all others. Analyses included all participants having non-missing baseline and endpoint.|Baseline, 12 weeks|Intent-to-treat (ITT) population: all randomized participants. ITT treatment group is group to which participant was randomized regardless of treatment actually received. BOCF method used to impute endpoint value if initial DBT discontinued due to AE. Change from baseline analyses included all those with baseline and ≤1 post-baseline observation.||Units on a scale||Standard Error|Least Squares Mean
800523|NCT00965094|Secondary|Change in Renal Function (Creatinine Slope)|X(slope)=(1/value of creatinine).|3 months, 5 months, 7 months, 9 months|The ITT population comprised all randomized patients who received at least one dose of the study medications after randomization and had at least one post-baseline assessment of the primary efficacy variable (renal function based on Nankivell method).||mg/dl per month||Standard Deviation|Mean
800524|NCT00965094|Secondary|Participants Who Had Occurrence of Treatment Failure.|Treatment failure was defined as a composite endpoint of biopsy-proven acute rejection, graft loss, death, loss to follow up, discontinuation due to lack of efficacy or toxicity or conversion to another regimen.|9 months|The ITT population comprised all randomized patients who received at least one dose of the study medications after randomization and had at least one post-baseline assessment of the primary efficacy variable (renal function based on Nankivell method)||Participants|||Number
800525|NCT00965094|Secondary|Participants Who Had Occurrence of Biopsy Proven Acute Rejection, Graft Loss or Death.|Biopsy-proven acute rejection was defined as a biopsy gradeed IA, IB, IIA, IIB, or III. The allograft was presumed to be lost if the patient started dialysis and was not able to subsequently be removed from dialysis. If the patient underwent a graft nephrectomy, then the day of nephrectomy was the day of graft loss.|9 months|The ITT population comprised all randomized patients who received at least one dose of the study medications after randomization and had at least one post-baseline assessment of the primary efficacy variable||Participants|||Number
800526|NCT00965094|Secondary|Assessment of GFR by the Cockcroft-Gault Method (LOCF)|the GFR was also calculated using the Cockcroft-Gault method (Cockcroft and Gault 1976) and the Modification of Diet in Renal Disease (MDRD) method (Levey et al., 1999, Rodrigo et al., 2003; Pierrat et al., 2003).Cockcroft-Gault formula For men: GFR= (140-Age)X Body Weight[kg]/72X Serum Creatinine[mg/dl] For women: GFR= 0,85x(140-Age) x Body Weight[kg]/72x Serum Creatinine [mg/dl] The Last Observation Carried Forward (LOCF) imputation technique was used for this analysis.|9 months|The ITT population comprised all randomized patients who received at least one dose of the study medications after randomization and had at least one post-baseline assessment of the primary efficacy variable||mL/min||Standard Deviation|Mean
800676|NCT00966875|Secondary|Change From Baseline in Disease Activity Score (DAS28)-Part A|DAS28 consisted of a composite score of the following variables: TJC28, SJC28, CRP, and PtGADA-VAS. DAS28 was calculated as: DAS28 − CRP =0.56(square root TJC28) + 0.28(square root SJC28) + 0.36(ln[CRP +1]) + 0.014(VAS) + 0.96. A negative change indicated an improvement.|Baseline, up to Week 12|Part A FAS: All randomized participants who received at least 1 dose of study drug; last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
800527|NCT00965094|Primary|Renal Function Assessed as Glomerula Filtration Rate (GFR) - Nankivell Method - 9 Months After Renal Transplantation (LOCF)|The glomerular filtration rate (GFR) is the best clinical estimate of renal function in health and disease, and correlates well with the clinical severity of renal function disturbances. The GFR, calculated according to the Nankivell formula, was used as the primary outcome measure in this study. This equation has been validated in renal transplant patients against the true GFR measured by a radionuclide method and has been confirmed as a very accurate method to calculate the GFR in this specific population (Gaspari et al., 2004)GFR = 6.7 / Scr + BW / 4 – Surea / 2-100 / (height)² + C Scr = serum creatinine concentration expressed in mmol/L. BW = body weight in kg, Surea = serum urea in mmol/L and Height is expressed in meters.The Last Observation Carried Forward (LOCF) imputation technique was used for this analysis.|9 months|The ITT population comprised all randomized patients who received at least one dose of the study medications after randomization and had at least one post-baseline assessment of the primary efficacy variable (renal function based on Nankivell method).||mL/min/1.73m^2||Standard Deviation|Mean
800528|NCT00965146|Primary|Evaluate Complication Rate.|This study was terminated prior to the protocol defined 15 year endpoint. As such, final outcome measures cannot be posted.|15 years||||||
800529|NCT00965146|Primary|Evaluate Component Design Effect on Functional Knee Society Score and Radiographic Findings.|This study was terminated prior to the protocol defined 15 year endpoint. As such, final outcome measures cannot be posted.|15 years||||||
800530|NCT00965185|Secondary|Liver Function Tests (LFTs)|"Number of participants with LFT abnormalities (greater than or equal to 3 times the upper limit of normal).
For reference, the normal ranges for AST and ALT are shown below. Please note that the normal range for ALT at Labcorp changed over the course of the study. AST and ALT elevations were determined based on the normal range at the time the lab test was performed.
ALT: 0-40 IU/L, 0-44 IU/L, or 0-55 IU/L AST: 0-40 IU/L"|Measured at baseline, 1, 3, 6, 9, and 12 months|All available data were used.||participants|||Number
800531|NCT00965185|Secondary|Adipocytokines||Measured at 1 year||||||
800532|NCT00965185|Secondary|C-reactive Protein (CRP)|12 month change in Log CRP concentration|Measured at baseline and 1 year|All available data were used.||log(mg/L)||95% Confidence Interval|Mean
800533|NCT00965185|Secondary|Lipid Profile|12 month change in lipid profile|Measured at baseline and 1 year|All available data were used.||mmol/L||95% Confidence Interval|Mean
800534|NCT00965185|Secondary|Immune Function|12 month change in CD4 T-lymphocytes|Measured at baseline and 1 year|All available data were used; data were not available for one subject who completed the study.||cells per microliter||95% Confidence Interval|Mean
800535|NCT00965185|Secondary|Endothelial Function||Measured at 1 year||||||
800536|NCT00965185|Secondary|Plaque Progression|12 month percent change in plaque volume|Measured at baseline and 1 year|All available data were used.||Percent change||95% Confidence Interval|Mean
800537|NCT00965185|Primary|Coronary and Aortic Plaque Inflammation|12 month change in mean FDG-PET TBR (18-fluorodeoxyglucose positron emission tomography target-to-background ratio)|Measured at baseline and 1 year|All participants with baseline and 12 month PET and CT scans of acceptable image quality to permit assessment of change over time in identical regions in serial scans. As a result, only a limited number of participants could be included.||ratio||95% Confidence Interval|Mean
800538|NCT00965237|Primary|Overall Satisfaction With the Lenses|Overall satisfaction with the lenses was interpreted by and assessed by the subject as a single, retrospective measurement of one week's wear time. Overall satisfaction with the lenses was recorded on a questionnaire as a numerical rating on a scale of 1 to 100, with 1 being completely dissatisfied, and 100 being excellent, completely satisfied.|1 week of wear|Analysis conducted per protocol||Units on a Scale||Standard Deviation|Mean
800539|NCT00965250|Secondary|Correlate Response to Therapy With Changes in FDG-PET Imaging|Participants with scans that showed neither sufficient shrinkage to qualify as an objective response nor sufficient increase to qualify as disease progression, taking as reference the smallest cumulative longest dimension since start of treatment, to have stable disease.|6 weeks after initiation of treatment|We did radiological assessment ourselves, and an independent radiological assessment was not undertaken for assessment of response or progression.|||||
800540|NCT00965250|Secondary|Median Number of Cycles of Therapy|A cycle is defined as 21 days or 6 weeks of therapy.|6 weeks|||Cycles||Full Range|Median
800541|NCT00965250|Secondary|Overall Survival|Time from treatment start date until date of death or date last known alive.|39 months|||Months||95% Confidence Interval|Median
800542|NCT00965250|Secondary|Time to Progression|Time between the first day of treatment to the day of disease progression.|39 months|||Months||95% Confidence Interval|Median
800543|NCT00965250|Secondary|Disease Control Rate (DCR)|Disease control rate is defined as objective response plus stable disease.|39 months|||percentage of participants||95% Confidence Interval|Number
800544|NCT00965250|Secondary|Percentage of Participants Who Respond to Treatment|Percentage of participants who respond to treatment was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST).|39 months|||percentage of participants||95% Confidence Interval|Number
800545|NCT00965250|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|81 months and 17 days|Adverse events are not separated by group because the adverse events are related to the drug which was the same in both groups.||Participants|||Number
800546|NCT00965250|Primary|Objective Response Rate (Partial Response (PR)+Complete Response (CR)) to IMC-A12 Monotherapy in Patients With Advanced or Recurrent Thymoma or Thymic Carcinoma.|Objective response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete response (CR) is the disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Patients were assessed for response every 2 cycles (every 6 weeks) while receiving the study drug.|||Participants|||Number
802961|NCT00988442|Secondary|Quality of Life Measured by Euro-QoL - Pain/Discomfort|Quality of Life Measured by Euro-QoL - Question 4: Pain/Discomfort.|Week 24|Available data from participants who reached week 24 are summarized.||Participants|||Count of Participants
800547|NCT00965341|Secondary|The Hospital Anxiety and Depression Scale (HADS) and Symptoms Scored by the Edmonton Symptom Assessment Scale (ESAS).|The ESAS assessed 10 symptoms experienced by cancer patients during the previous 24 hours: pain, fatigue, nausea, depression, anxiety, drowsiness, dyspnea, anorexia, sleep disturbance, and feelings of well-being. The severity of each symptom is rated on a numerical scale of 0–10 (0 = no symptom, 10 = worst possible severity). Depression was assessed using the 14-item HADS questionnaire. Each item on the questionnaire was scored from 0-3. Total Scores for the HADS Questionnaire range from 0 to 42 with higher scores denoting feeling of depression.|Day 29 (+/- 3 days)|||units on a scale||Standard Deviation|Mean
800548|NCT00965341|Primary|Functional Assessment of Cancer Therapy-Fatigue Subscale (FACIT-F) at Day 29 (+/- 3 Days)|The primary endpoint was to evaluate the effect of testosterone replacement therapy on fatigue in hypogonadic male patients with advanced cancer, measured by the Functional Assessment of Cancer Therapy-Fatigue subscale (FACIT-F) at day 29 (+/- 3 days). FACIT-F consists of 27 general quality-of-life questions divided into 4 domains (physical, social, emotional, and functional), plus a 13-item fatigue subscore. The participant rates the intensity of fatigue and its related symptoms on a scale of 0–4. The FACIT-F total score ranged between 0 and 108, with higher scores denoting improved function. The FACIT-F Fatigue Subscale ranges from 0 to 52, with higher scores represent better (less) fatigue than a lower score. A positive difference score (29 days minus baseline) represents improvement. A greater positive difference score represents greater improvement.|Day 29 (+/- 3 days)|||units on a scale||Standard Deviation|Mean
800555|NCT00965484|Secondary|Percentage of Dyads Reporting New Genotropin Mark VII Injection Pen Preferable Compared to Pre-study Experience With the Genotropin Pen®|Preference for use measured using IPAQ PRO tool (ease of use and preference based on 13 unique characteristics of injection pens). Section I measures ease of use of Genotropin® (very easy, somewhat easy, neither easy nor difficult, somewhat difficult, or very difficult). Section II measures ease of use of new Genotropin Mark VII Pen in comparison to pre-study experience with Genotropin® Pen (Genotropin® Pen easier to use, new injection pen easier to use, or no difference) and preference (prefer Genotropin® Pen, prefer new injection pen, or no preference).|2 months|FAS; number of participants with measurement.||percentage of dyads||95% Confidence Interval|Number
800556|NCT00965484|Secondary|Percentage of Dyads Reporting New Genotropin Mark VII Injection Pen Easier to Use Compared to Pre-study Experience With the Genotropin Pen®|Ease of use measured using the IPAQ PRO tool (ease of use and preference based on 13 unique characteristics of injection pens). Section I measures ease of use of Genotropin® Pen (very easy, somewhat easy, neither easy nor difficult, somewhat difficult, or very difficult). Section II measures ease of use of new Genotropin Mark VII Pen in comparison to pre-study experience with Genotropin® Pen (Genotropin® Pen easier to use, new injection pen easier to use, or no difference) and preference (prefer Genotropin® Pen, prefer new injection pen, or no preference).|2 months|FAS||percentage of dyads||95% Confidence Interval|Number
800557|NCT00965484|Secondary|Percentage of Dyads Reporting no Preference or Preference for New Genotropin Mark VII Injection Pen Compared to Pre-study Experience With the Genotropin Pen®|Preference for use measured using IPAQ PRO tool (ease of use and preference based on 13 unique characteristics of injection pens). Section I measures ease of use of Genotropin® (very easy, somewhat easy, neither easy nor difficult, somewhat difficult, or very difficult). Section II measures ease of use of new Genotropin Mark VII Pen in comparison to pre-study experience with Genotropin® Pen (Genotropin® Pen easier to use, new injection pen easier to use, or no difference) and preference (prefer Genotropin® Pen, prefer new injection pen, or no preference).|2 months|FAS; N=number of participants with measurement.||percentage of dyads||95% Confidence Interval|Number
800558|NCT00965484|Primary|Percentage of Dyads (Participant and Caregiver or Parent) Reporting no Difference or Easier to Use for New Genotropin Mark VII Injection Pen Compared to Pre-study Experience With the Genotropin Pen®|Ease of use measured using the Injection Pen Assessment Questionnaire (IPAQ) patient-reported outcome (PRO) tool (based on 13 unique characteristics of injection pens). Section I measures ease of use of Genotropin® (very easy, somewhat easy, neither easy nor difficult, somewhat difficult, or very difficult). Section II measures ease of use of new Genotropin Mark VII Pen in comparison to pre-study experience with Genotropin® Pen (Genotropin® pen easier to use, new injection pen easier to use, or no difference) and preference (prefer Genotropin® Pen, prefer new injection pen, or no preference).|2 months|Full analysis set (FAS): all participants who used the new pen at least once to administer Genotropin and who completed the 2-month follow-up questionnaire. Dyad defined as the participant (child being treated) and adult partner (parent or caregiver).||percentage of dyads||95% Confidence Interval|Number
800559|NCT00965497|Secondary|McGill Quality of Life Scale (MQOL)|McGill Quality of Life Scale is a a 20-item scale measuring quality of life in chronic and end of life conditions. MQOL is self-reported with a 2-day time frame. Items are scored 0 (worst) to 10 (excellent)on five domains (physical well-being, physical symptoms, psychological, existential, and support). An overall index score can be calculated from the means of the five sub-scales measuring quality of life from 0 (poor) to 10 (excellent).|8 weeks|||quality of life||Full Range|Mean
800560|NCT00965497|Primary|Hamilton Depression Scale (HAM-D 17).|Hamilton Depression Rating Scale-17 (HAM-D) is a 17-item observer rated scale that measures depressive symptoms. Items are rated 0 (no symptoms)-4 ( most severe symptoms. Possible minimum and maximum scores range is 0-50. total score indications: 0-7 = Normal; 8-13 = Mild Depression; 14-18 = Moderate Depression; 19-22 = Severe Depression and ≥ 23 = Very Severe Depression.|8 weeks|Intention to Treat||depression severity||Standard Deviation|Median
800561|NCT00965523|Secondary|Objective Response Rate (ORR) as Measured by Response Evaluation Criteria in Solid Tumors (RECIST)|Objective response measured by Response Evaluation Criteria In Solid Tumors (RECIST) criteria and is Complete Response (disappearance of all target lesions) plus Partial Response (at least 30% decrease in sum of longest diameter [LD] of target lesions compared baseline sum of LD). Tumor assessments every 6 weeks.|Every 6 weeks|Full Analysis Set||percentage of subjects|||Number
800562|NCT00965523|Primary|Number of Subjects With Adverse Events.||Every week during treatment and up to 30 days after last dose of study treatment|Safety Analysis Set||Participants|||Number
800563|NCT00965562|Primary|Comparison of the Change in CGI Improvement Scores Among Groups|CGI-I = Clinical Global Impression Improvement: the improvement subscale of CGI measuring change at each visit as compared to visit 1 (1=very much improved, 7=very much worse). This outcome is a measure of effect size between the two trial groups and the placebo group, with the placebo effect size value used as a reference.|over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit|Intention to treat cohort.||units on CGI Improvement scale||Standard Deviation|Mean
800564|NCT00965562|Primary|Comparison of the Change in DRSP Symptom Scores Among Groups|DRSP = Daily Record of Severity of Problems, which combines responses to 21 items each with scale: 1=no symptoms, 6=extreme. This outcome is a measure of effect size between the two trial groups and the placebo group, with the placebo effect size value used as a reference.|over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit|Intention to treat cohort.||units on DRSP scale||Standard Deviation|Mean
800565|NCT00965562|Primary|Comparison of the Change in CGI-S Symptom Scores Among Groups|CGI-S = Clinical Global Impression-Severity: a severity scale widely used in psychopharmacology research (1=normal not at all ill, 7=among most extremely ill). This outcome is a measure of effect size between the two trial groups and the placebo group, with the placebo effect size value used as a reference.|over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit|Intention to treat cohort.||units on CGI-S scale||Standard Deviation|Mean
800566|NCT00965562|Primary|Comparison of the Change in PMTS Symptom Scores Among Groups|PMTS = Premenstrual Tension Syndrome (Observer Rating) Scale: a clinician-administered retrospective scale developed for the study of PMS, a sum of responses to 10 items each with 4 points (0=no symptoms, 40=most severe). This outcome is a measure of effect size between the two trial groups and the placebo group, with the placebo effect size value used as a reference.|over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit|Intention to treat cohort.||units on PMTS scale||Standard Deviation|Mean
800567|NCT00965562|Primary|Comparison of the Change in IDS Symptom Scores Among Groups|IDS = Inventory of Depressive Symptomatology: measures depressive symptoms during the previous premenstrual phase with high internal consistency: sum of responses to 28 of 30 possible items each scored 0 to 3 points with total scoring (0=no symptoms, 84=most severe). This outcome is a measure of effect size between the two trial groups and the placebo group, with the placebo effect size value used as a reference.|over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit|Intention to treat cohort.||units on IDS scale||Standard Deviation|Mean
811707|NCT01059760|Primary|Change From Baseline in Participant Mean Corpuscular Hemoglobin (MCH) When Fasting and Fed||Baseline and 3 days|||pg||Standard Deviation|Mean
800568|NCT00965562|Secondary|Proportion of Patients With PMTS Visit-wise Response to Treatment (50% Improvement)|Visit-wise response considers participants who remained in the study until Visit 5 and provided data for the visit. PMTS = Premenstrual Tension Syndrome (Observer Rating) Scale: a clinician-administered retrospective scale developed for the study of PMS, a sum of responses to 10 items each with 4 points (0=no symptoms, 40=most severe).|over duration of treatment from baseline to visit 5, including 4 menstrual cycles averaging 4 months after baseline visit|For fluoxetine, calcium and placebo groups, 8, 11 and 12 participants remained in the trial until Visit 5.||proportion of participants|||Number
800569|NCT00965562|Secondary|Proportion of Patients With IDS Visit-wise Response to Treatment (50% Improvement)|"Visit-wise response considers participants who remained in the study until Visit 5 and provided data for the visit.
IDS = Inventory of Depressive Symptomatology: measures depressive symptoms during the previous premenstrual phase with high internal consistency, sum of responses to 28 of 30 possible items each scored 0 to 3 points with total scoring (0=no symptoms, 84=most severe)."|over duration of treatment from baseline to visit 5, including 4 menstrual cycles averaging 4 months after baseline visit|For fluoxetine, calcium and placebo groups, 8, 11 and 12 participants remained in the trial until Visit 5.||proportion of participants|||Number
800570|NCT00965562|Secondary|Proportion of Participants With DRSP Visit-wise Response to Treatment (50% Improvement)|Visit-wise response considers participants who remained in the study until Visit 5 and provided data for the visit. DRSP = Daily Record of Severity of Problems, which combines responses to 21 items each with scale: 1=no symptoms, 6=extreme.|over duration of treatment from baseline to visit 5, including 4 menstrual cycles averaging 4 months after baseline visit|For fluoxetine, calcium and placebo groups, 8, 11 and 12 participants remained in the trial until Visit 5. However, Visit 5 DRSP calendars were missing for an additional 3 subjects in the fluoxetine group and for one subject in each of the calcium and placebo cells.||proportion of participants|||Number
800571|NCT00965562|Secondary|Proportion of Participants With PMTS LOCF Response to Treatment (50% Improvement)|PMTS: Premenstrual Tension Syndrome (Observer Rating) Scale: a clinician-administered retrospective scale developed for the study of PMS, a sum of responses to 10 items each with 4 points (0=no symptoms, 40=most severe). LOCF: last observation carried forward.|over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit|Response analysis includes all data from all subjects with the last observation carried forward to Visit 5.||proportion of participants|||Number
800572|NCT00965562|Secondary|Proportion of Participants With IDS LOCF Response to Treatment (50% Improvement)|IDS: Inventory of Depressive Symptomatology: measures depressive symptoms during the previous premenstrual phase with high internal consistency: sum of responses to 28 of 30 possible items each scored 0 to 3 points with total scoring (0=least severe, 84=most severe). LOCF: last observation carried forward.|over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit|Response analysis includes all data from all subjects with the last observation carried forward to Visit 5.||proportion of participants|||Number
800573|NCT00965562|Secondary|Proportion of Participants With DRSP LOCF Response to Treatment (50% Improvement)|DRSP: Daily Record of Severity of Problems, which combines responses to 21 items each with scale: 1=no symptoms, 6=extreme. LOCF: the last observation carried forward.|over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit|Response analysis includes all data from all subjects with the last observation carried forward to Visit 5.||proportion of participants|||Number
800574|NCT00965718|Primary|Progressive Disease(PD)|Of the 16 patients in the ITT population, progressive disease (PD) was confirmed. Disease control rate was calculated based on the number of CR or PR or SD patients in the ITT population.|Every 2 months from the baseline, up to 16 weeks|Patients who underwent response evaluation at least once were included in the intention-to-treat (ITT) population.||number of participants|||Number
800575|NCT00965718|Primary|Stable Disease(SD)|Of the 16 patients in the ITT population, stable disease(SD) was confirmed. Disease control rate was calculated based on the number of CR or PR or SD patients in the ITT population.|Every 2 months from the baseline, up to 16 weeks|Patients who underwent response evaluation at least once were included in the intention-to-treat (ITT) population.||number of participants|||Number
800576|NCT00965718|Secondary|Quality of Life (QoL) Assessed Using Quality of Life Questionnaire Core 30(QLQ-C30) in Patients With Pancreatic Cancer(QLQ-PAN26 Questionnaire)|QLQ-PAN26 consists of questions (Qs) relating to disease symptoms, treatment (Tx) side effects and emotional issues specific to pancreatic cancer (PC). Questions include on altered bowel habits, pain, dietary changes, disease and Tx-related symptoms and issues related to the emotional and social well-being of participants with PC. All Qs are answered on 4-point Likert scale ranging from '1=not at all' to 4='very much' and subsequently transformed into scales that range from 0-100; higher scores= greater degree of symptoms or treatment side effects and emotional issues.|Every one month from the baseline, up to 16 weeks|Patients who underwent response evaluation at least once were included in the intention-to-treat (ITT) population.||units on a scale||Standard Deviation|Mean
800577|NCT00965718|Secondary|Quality of Life (QoL) Assessed Using the Quality of Life Questionnaire Core 30 (QLQ-C30)|QLQ-C30 constitutes a functional scale(physical, role, emotional, cognitive, and social functioning), symptom scores scale(fatigue, nausea/vomiting, pain, dyspnea, constipation, diarrhea, insomnia, appetite loss, financial difficulties), and global QoL scale. With the scores of all scales ranging from 0 to 100, a higher score indicates a better functional scale and a better global QoL scale as well as a worse symptom scores scale.|Every one month from the baseline, up to 16 weeks|Patients who underwent response evaluation at least once were included in the intention-to-treat (ITT) population.||units on a scale||Standard Deviation|Mean
800578|NCT00965718|Secondary|Time to Progression|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. Unequivocal progression of existing non-target lesions.|Every 2 months from the baseline, up to 16 weeks|Patients who underwent response evaluation at least once were included in the intention-to-treat (ITT) population.||weeks||95% Confidence Interval|Median
800579|NCT00965718|Secondary|Overall Survival (OS)|OS was calculated from the date of enrollment until death from any cause. And OS was estimated using Kaplan-Meier methods with 95% confidence intervals (CIs).|Every visit, up to 16 weeks|Patients who underwent response evaluation at least once were included in the intention-to-treat (ITT) population.||weeks||95% Confidence Interval|Median
800580|NCT00965718|Primary|Disease Control Rate|"Disease control rate is defined as the number of patients with a best overall response of complete response (CR), partial response (PR), or stable disease (SD) using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1). Complete Response: Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study.
Disease control rate = CR or PR or SD patients / ITT population *100"|Every 2 months from the baseline, up to 16 weeks|Patients who underwent response evaluation at least once were included in the intention-to-treat (ITT) population.||percentage of participants||95% Confidence Interval|Number
800581|NCT00965731|Other Pre-specified|Recommended Phase 2 Dose (RP2D) of PF-02341066 When Administered in Combination With Erlotinib (Phase 1)|If no more than 1/6 participants presented with a DLT during Cycle 1 at the MTD, then this dose level was considered the RP2D. If >1/6 participants experienced a DLT, then the previous lower level was considered the MTD and RP2D.|Baseline up to 28 days (Cycle 1)|DLT evaluable population||mg|||Number
800582|NCT00965731|Other Pre-specified|Maximum Tolerated Dose (MTD) of PF-02341066 When Administered in Combination With Erlotinib (Phase 1)|MTD: the combination dose level of PF-02341066 and erlotinib in which 0/6 or 1/6 participants experienced DLT after 28 days of treatment (Cycle 1) with the next higher dose level having at least 2/3 or 2/6 participants with DLT during Cycle 1 of treatment.|Baseline up to 28 days (Cycle 1)|DLT evaluable population||mg|||Number
800583|NCT00965731|Secondary|Percentage of Participants With Mutations in Tumor Tissue (Phase 2)|Tumor tissue samples collected for molecular profiling were to be analyzed to assess Kirsten rat sarcoma (KRAS) mutations, mutations, amplification and expression of Epidermal Growth Factor Receptor (EGFR) and c-Met, and echinoderm microtubule-associated protein-like 4-anaplastic large cell receptor kinase (EML4-ALK) fusion in tumors.|Screening|Not analyzed due to phase 2 study termination|||||
800584|NCT00965731|Secondary|Plasma Concentration of Erlotinib (Phase 2)|Plasma concentration of erlotinib when administered as a single agent during phase 2|Day 1 of cycles 1, 3, and 5 (i.e., up to 15 weeks) at 0 hours (pre-dose)|Not analyzed due to phase 2 study termination|||||
800585|NCT00965731|Secondary|Plasma Concentration of PF-02341066 and Erlotinib (Phase 2)|Plasma concentration of PF-02341066 and erlotinib when administered in combination during phase 2|Day 1 of cycles 1, 3, and 5 (i.e., up to 15 weeks) at 0 (pre-dose) and 2 to 6 hours post dose|Not analyzed due to phase 2 study termination|||||
800586|NCT00965731|Secondary|EORTC Quality of Life Questionnaire -Lung Cancer 13 (QLQ-LC13) Score at Phase 2|QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, neuropathy, alopecia, and medicine for pain). Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.|Baseline and every 21 days, up to 20 months|Not analyzed due to phase 2 study termination|||||
800587|NCT00965731|Secondary|European Organization for Research and Treatment of Cancer (EORTC), Quality of Life Questionnaire (QLQ-C30) Score at Phase 2|Phase 2 EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms.|Baseline and every 21 days, up to 20 months|Not analyzed due to phase 2 study termination|||||
800588|NCT00965731|Secondary|Overall Survival (OS) at Phase 2|Time in months from randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 30.4.|Baseline until death, up to 20 months|Not analyzed due to phase 2 study termination|||||
800589|NCT00965731|Secondary|Percentage of Participants With Objective Response (Phase 2)|Percentage of participants during phase 2 with objective response based assessment of confirmed CR or confirmed PR according to RECIST (1.1). Confirmed responses: persist on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions and disappearance of all non-target lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of nontarget disease. No new lesions.|Baseline, every 42 days up to 20 months, disease progression, or unacceptable toxicity|Not analyzed due to phase 2 study termination|||||
800590|NCT00965731|Secondary|Percentage of Participants With Confirmed CR, PR or Stable Disease (SD) at Phase 2|Percentage of participants during phase 2 with confirmed CR, confirmed PR or SD according to RECIST 1.1. Also known as Disease Control Rate (DCR). CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions and disappearance of all non-target lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of nontarget disease. No new lesions. SD: neither sufficient shrinkage or increase to qualify for PR or PD.|Week 6 and Week 12|Not analyzed due to phase 2 study termination|||||
800602|NCT00965731|Secondary|Erlotinib Maximum Observed Plasma Concentration (Cmax) (Phase 1)|Cmax is a measure of the plasma exposure to erlotinib. In this study, it is used to characterize erlotinib exposure after multiple doses of erlotinib were administered alone (Day -1) and in combination of PF-02341066 (Cycle 1 Day 1 and Day 15).|C1D-1 i.e., 1 day prior to initiation of continuous dosing of crizotinib; C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib|Pharmacokinetic (PK) parameter analysis population included all participants in safety analysis set 1 who had at least 1 of the PK parameters of interest. Number of participants analyzed section in below table includes number of participants in PK analysis population. N=number of participants in treatment group contributing to summary statistics.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
800591|NCT00965731|Secondary|Duration of Response (Phase 2)|Median duration (50%) of tumor response. DR defined as time from start of first documented objective tumor response (CR or PR) to first documented objective tumor progression or death due to any cause, whichever occurs first. DR calculated as (Weeks) = (the end date for DR minus first subsequent confirmed CR or PR plus 1) divided by 7.02. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions and disappearance of all non-target lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of nontarget disease. No new lesions.|Baseline, every 42 days up to 20 months, disease progression, or unacceptable toxicity|Not analyzed due to phase 2 study termination|||||
800592|NCT00965731|Secondary|Plasma Level of Soluble Marker: HGF Scatter Factor (Phase 2)||Baseline and Day 50 (Cycle 3, Day 1)|Not analyzed due to phase 2 study termination|||||
800593|NCT00965731|Secondary|Plasma Level of Soluble Marker: c-Met Ectodomain (Phase 2)||Baseline and Day 50 (Cycle 3, Day 1)|Not analyzed due to phase 2 study termination|||||
800594|NCT00965731|Secondary|Plasma Level of Soluble Marker: Hepatocyte Growth Factor (HGF) Scatter Factor (Phase 1)||Baseline and Day 50 (Cycle 3, Day 1)|Plasma level of soluble marker HGF scatter factor not analyzed due to prior experience with high levels of intra participant variability|||||
800595|NCT00965731|Secondary|Plasma Level of Soluble Marker: c-Met Ectodomain (Phase 1)|Levels of soluble protein biomarker c-MET was analyzed at Baseline and at Day 50.|Baseline and Day 50 (Cycle 3, Day 1)|The soluble biomarker evaluable population was defined as participants from the safety analysis set of phase 1 who had a soluble protein blood sample taken prior to dosing on Cycle 3 Day 1 and 1 soluble biomarker evaluation after dosing on Cycle 3 Day 1.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
800596|NCT00965731|Secondary|Percentage of Participants With Objective Response (Phase 1)|Percentage of participants during phase 1 with objective response based assessment of confirmed CR or confirmed PR according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Confirmed responses: persist on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions and disappearance of all non-target lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of nontarget disease. No new lesions.|Baseline, every 42 days until disease progression or unacceptable toxicity|Response Evaluable Population: all participants enrolled into the Phase 1 portion of the study who receive at least one dose of study medication (either PF-02341066 or erlotinib) and have an adequate baseline tumor assessment.||percentage of participants||95% Confidence Interval|Number
800597|NCT00965731|Secondary|Duration of Response (Phase 1)|Median duration (50 percent [%]) of tumor response. Duration of response (DR) defined as time from start of first documented objective tumor response [Complete Response (CR) or Partial Response (PR)] to first documented objective tumor progression or death due to any cause, whichever occurs first. DR calculated as (Weeks) = (the end date for DR minus first subsequent confirmed CR or PR plus 1) divided by 7.02. CR: disappearance of a target lesions. PR: at least 30% decrease in the sum of diameters of target lesions.|Baseline, every 42 days until disease progression or unacceptable toxicity|not analyzed due to small number of responses|||||
800598|NCT00965731|Secondary|Progression-Free Survival (Phase 1)|"Time in weeks from phase 1 randomization to first documentation of objective disease progression or death due to any cause. Progression-Free Survival was calculated as (first event date minus randomization date plus 1) divided by 7.02. Tumor progression was determined from oncologic assessment data (where data meet the criteria for PD), or from AE data (where the outcome was Death; date of death reported in notice of death was used)."|Baseline, every 42 days until disease progression or unacceptable toxicity|not analyzed due to small number of study participants|||||
800599|NCT00965731|Secondary|Ratio of Adjusted Means of Erlotinib Cmax (Crizotinib + Erlotinib / Erlotinib Alone) (Phase 1)|Ratio of adjusted means of Erlotinib Cmax (Crizotinib + Erlotinib / Erlotinib Alone) is a measure of the plasma exposure to erlotinib after erlotinib dosing with crizotinib compared with that after erlotinib dosing alone. In this study, it is used to characterize the effect magnitude of crizotinib on the erlotinib exposure after combinational use of crizotinib and erlotinib.|C1D-1 (i.e., 1 day prior to initiation of continuous dosing of crizotinib) to C1D15 (i.e., 15 days of giving crizotinib and erlotinib)|The pharmacokinetic (PK) parameter analysis population was defined as all participants in the safety analysis set 1 who had at least 1 of the PK parameters of interest.||Ratio in percentage||90% Confidence Interval|Geometric Mean
800600|NCT00965731|Secondary|Ratio of Adjusted Means of Erlotinib AUCtau (Crizotinib + Erlotinib / Erlotinib Alone) (Phase 1)|Ratio of adjusted means of Erlotinib AUCtau (Crizotinib + Erlotinib / Erlotinib Alone) is a measure of the plasma exposure to erlotinib after erlotinib dosing with crizotinib compared with that after erlotinib dosing alone. In this study, it is used to characterize the effect magnitude of crizotinib on the erlotinib exposure after combinational use of crizotinib and erlotinib.|C1D-1 (i.e., 1 day prior to initiation of continuous dosing of crizotinib) to C1D15 (i.e., 15 days of giving crizotinib and erlotinib)|The PK parameter analysis population was defined as all participants in the safety analysis set 1 who had at least 1 of the PK parameters of interest.||Ratio in percentage||90% Confidence Interval|Geometric Mean
800601|NCT00965731|Secondary|Erlotinib Apparent Oral Clearance (CL/F) (Phase 1)|Apparent oral Clearance is a measure of combination of the rate at which a drug is removed from the blood (CL) and the bioavailability (F) after oral dose. In this study, it is used to characterize erlotinib CL/F after multiple doses in combination with PF-02341066 (Cycle 1 Day 15).|C1D15 i.e., 15 days of giving crizotinib and erlotinib|The pharmacokinetic (PK) parameter analysis population was defined as all participants in the safety analysis set 1 who had at least 1 of the PK parameters of interest.||L/hr||Geometric Coefficient of Variation|Geometric Mean
800642|NCT00966823|Secondary|Maternal Complications||Intervention to 30 days postpartum|||occurrences|||Number
800643|NCT00966823|Secondary|Newborn Survival at 30 Days||30 days|1 of 2 enrolled participants (fetuses) survived until birth (Primary outcome). This 1 participant (infant) also survived at 30 days (secondary outcome).||Participants|||Number
800603|NCT00965731|Secondary|Erlotinib Area Under the Concentration-Time Curve During Dosing Interval (AUCtau) (Phase 1)|AUCtau is a measure of the plasma exposure to erlotinib. In this study, it is used to characterize erlotinib exposure after multiple doses of erlotinib were administered alone (Day -1) and in combination of PF-02341066 (Cycle 1 Day 1 and Day 15).|C1D-1 i.e., 1 day prior to initiation of continuous dosing of crizotinib; C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib|Pharmacokinetic (PK) parameter analysis population included all participants in safety analysis set 1 who had at least 1 of the PK parameters of interest. Number of participants analyzed section in below table includes number of participants in PK analysis population. N=number of participants in treatment group contributing to summary statistics.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
800604|NCT00965731|Secondary|Molecular Weight Adjusted PF-06260182-to-PF-02341006 Ratio of AUCtau (Phase 1)|Molecular weight adjusted PF-06260182-to-PF-02341006 ratio of AUCtau is a measure of how much PF-02341066 (parent drug) was converted to the metabolite PF-06260182 after PF-02341066 dosing. In this study, it is used to characterize the metabolite-to-parent ratio exposure after a single dose (Cycle 1 Day 1) and multiple doses (Cycle 1 Day 15) of PF-02341066 were administered in combination of Erlotinib.|C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib|Pharmacokinetic (PK) parameter analysis population included all participants in safety analysis set 1 who had at least 1 of the PK parameters of interest. Number of participants analyzed section in below table includes number of participants in PK analysis population. N=number of participants in treatment group contributing to summary statistics.||Ratio||Geometric Coefficient of Variation|Geometric Mean
800605|NCT00965731|Secondary|PF-06260182 Maximum Observed Plasma Concentration (Cmax) (Phase 1)|Cmax is a measure of the plasma exposure to PF-06260182, a PF-02341066 metabolite. In this study, it is used to characterize the metabolite exposure after a single dose (Cycle 1 Day 1) and multiple doses (Cycle 1 Day 15) of PF-02341066 were administered in combination of Erlotinib.|C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib|Pharmacokinetic (PK) parameter analysis population included all participants in safety analysis set 1 who had at least 1 of the PK parameters of interest. Number of participants analyzed section in below table includes number of participants in PK analysis population. N=number of participants in treatment group contributing to summary statistics.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
800606|NCT00965731|Secondary|PF-06260182 Area Under the Concentration-Time Curve During Dosing Interval (AUCtau) (Phase 1)|AUCtau is a measure of the plasma exposure to PF-06260182, a PF-02341066 metabolite. In this study, it is used to characterize the metabolite exposure after a single dose (Cycle 1 Day 1) and multiple doses (Cycle 1 Day 15) of PF-02341066 were administered in combination of Erlotinib.|C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib|Pharmacokinetic (PK) parameter analysis population included all participants in safety analysis set 1 who had at least 1 of the PK parameters of interest. Number of participants analyzed section in below table includes number of participants in PK analysis population. N=number of participants in treatment group contributing to summary statistics.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
800607|NCT00965731|Secondary|PF-02341066 (Crizotinib) Apparent Oral Clearance (CL/F) (Phase 1)|Apparent oral Clearance is a measure of combination of the rate at which a drug is removed from the blood (CL) and the bioavailability (F) after oral dose. In this study, It is used to characterize PF-02341066 CL/F after multiple doses (Cycle 1 Day 15) of PF-02341066 were administered in combination of Erlotinib.|C1D15 i.e., 15 days of giving crizotinib and erlotinib|The pharmacokinetic (PK) parameter analysis population was defined as all participants in the safety analysis set 1 who had at least 1 of the PK parameters of interest.||L/hr||Geometric Coefficient of Variation|Geometric Mean
800608|NCT00965731|Secondary|PF-02341066 (Crizotinib) Maximum Observed Plasma Concentration (Cmax) (Phase 1)|Cmax is a measure of the plasma exposure to PF-02341066. In this study, it is used to characterize PF-02341066 exposure after a single dose (Cycle 1 Day 1) and multiple doses (Cycle 1 Day 15) of PF-02341066 were administered in combination of Erlotinib|C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib|Pharmacokinetic (PK) parameter analysis population included all participants in safety analysis set 1 who had at least 1 of the PK parameters of interest. Number of participants analyzed section in below table includes number of participants in PK analysis population. N=number of participants in treatment group contributing to summary statistics.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
800609|NCT00965731|Secondary|PF-02341066 (Crizotinib) Area Under the Concentration-Time Curve During Dosing Interval (AUCtau) (Phase 1)|AUCtau is a measure of the plasma exposure to PF-02341066. In this study, it is used to characterize PF-02341066 exposure after a single dose (Cycle 1 Day 1) and multiple doses (Cycle1 Day 15) of PF-02341066 were administered in combination of Erlotinib.|Cycle 1 (C1) Day 1 (D1) i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib|Pharmacokinetic (PK) parameter analysis population included all participants in safety analysis set 1 who had at least 1 of the PK parameters of interest. Number of participants analyzed section in below table includes number of participants in PK analysis population. N=number of participants in treatment group contributing to summary statistics.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
800610|NCT00965731|Primary|Progression-Free Survival (Phase 2)|"Time in weeks from phase 2 study randomization to first documentation of objective disease progression or death due to any cause. Progression-Free Survival was calculated as (first event date minus randomization date plus 1) divided by 7.02. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from AE data (where the outcome was Death; date of death reported in notice of death was used)."|Baseline, every 42 days up to 20 months, disease progression, or unacceptable toxicity|Not analyzed due to phase 2 study termination|||||
800644|NCT00966823|Primary|Newborn Survival at Birth||Newborn period (1 day)|||Participants|||Number
800677|NCT00966875|Secondary|Smallest Doses That Achieve 10%, 50%, and 90% of the Maximum ACR50 Response in bDMARD-Naive Population|ACR50 responders were participants with at least 50% improvement from baseline for TJC, SJC, and at least 3 of the 5 remaining core set measures: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, and PhGA-VAS. Missing values were imputed using NRI.|Week 12|Part A FAS: All randomized participants who received at least 1 dose of study drug and were bDMARD-naive.||log (dose) mg|||Number
800611|NCT00965731|Primary|Number of Participants With Dose-Limiting Toxicities (DLT) (Phase 1)|Phase 1, first cycle DLT includes Grade (Gr) ≥4 hematologic possible drug-related toxicities and Gr ≥3 possible drug-related febrile neutropenia. Gr ≥3 non-hematological possible drug-related toxicities (except asymptomatic lab value elevation). Gr 3/4 nausea, vomiting or diarrhea. Gr 3 hypertension considered DLT if event unmanageable by approved pharmacologic agents or symptomatic sequelae despite medical intervention. Diagnosis of interstitial lung disease. Inability to deliver at least 80 percent (%) of planned dose during cycle 1 due to possible drug-related adverse events (AEs).|Baseline up to Day 28|DLT evaluable population: all participants in dose escalation phase receiving at least 1 dose of study medication who did not have a major treatment deviation during the first cycle (for example, less than 80% of planned dose of PF-02341066 or erlotinib in cycle 1 for reasons other than treatment-related toxicities)||participants|||Number
800612|NCT00965757|Primary|Percentage of American College of Rheumatology [ACR] 20 Criteria Responders|ACR20 response is defined as at least a 20% improvement in tender joint count and swollen joint count, and in three of five of the following measures: patient pain intensity assessment, patient global assessment, physician global assessment, Health assessment questionnaire disability index (HAQ-DI), and an acute phase reactant [erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)].|Week 24 Last Observation Carried Forward (LOCF) (for T-614 arm and placebo arm) and Week 52 LOCF (for T-614 arm and placebo/T614 arm)|Full Analysis Set (Double-blind), Efficacy Analysis Set (Extension)||Percentage of Participants||95% Confidence Interval|Number
800613|NCT00965757|Secondary|Percentage of ACR 70 Criteria Responders|ACR70 response is defined as at least a 70% improvement in tender joint count and swollen joint count, and in three of five of the following measures: patient pain intensity assessment, patient global assessment, physician global assessment, Health assessment questionnaire disability index (HAQ-DI), and an acute phase reactant [erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)].|Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)|FAS (Double-blind), Efficacy Analysis Set (Extension)||Percentage of Participants||95% Confidence Interval|Number
800614|NCT00965757|Secondary|Percentage of ACR 50 Criteria Responders|ACR50 response is defined as at least a 50% improvement in tender joint count and swollen joint count, and in three of five of the following measures: patient pain intensity assessment, patient global assessment, physician global assessment, Health assessment questionnaire disability index (HAQ-DI), and an acute phase reactant [erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)].|Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)|Full Analysis Set (Double-blind), Efficacy Analysis Set (Extension)||Percentage of Participants||95% Confidence Interval|Number
800615|NCT00965757|Secondary|Disease Activity Score in 28 Joints (DAS28): The Rates of Remission (DAS28-CRP Less Than 2.6), and Low Disease Activity (DAS28-CRP Less Than 3.2)|The DAS28 is a composite score derived from 4 of these measures i.e count of 28 swollen joints, 28 tender joints, measure erythrocyte sedimentation rate (ESR) or C reactive protein (CRP) and to make a 'global assessment of health' (indicated by marking a 10 cm line between very good and very bad). DAS28 is assessed as score on scale from 0 to 10 indicating current rheumatoid arthritis (RA) disease activity (0= low disease activity and 10 = high disease activity).|Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)|FAS (Double-blind), Efficacy Analysis Set (Extension)||participants|||Number
800616|NCT00965757|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR)|Assessment of individual ACR core components i.e. ESR|Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)|FAS (Double-blind), Efficacy Analysis Set (Extension)||mm/hr||Standard Deviation|Mean
800617|NCT00965757|Secondary|Change From Baseline in C-reactive Protein (CRP)|Assessment of individual ACR core components i.e. CRP|Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)|FAS (Double-blind), Efficacy Analysis Set (Extension)||mg/dl||Standard Deviation|Mean
800618|NCT00965757|Secondary|Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)|HAQ-DI was a participant assessed measure of health assessment, measured on a single scale ranging from 0 (no difficulty) to 3 (unable to do), with higher scores indicating severe disease.|Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)|FAS (Double-blind), Efficacy Analysis Set (Extension)||score on scale||Standard Deviation|Mean
800619|NCT00965757|Secondary|Change From Baseline in PAP, PtGADA and PyGADA|Patient's assessment of pain (PAP), patient's global assessment of disease activity (PtGADA) and physician's global assessment of disease activity (PyGADA) each was assessed on a visual analog scale ranging from 0–100 mm, with higher scores indicating severe disease.|Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)|FAS (Double-blind), Efficacy Analysis Set (Extension)||mm||Standard Deviation|Mean
800620|NCT00965757|Secondary|Change From Baseline in Tender Joint Counts and Swollen Joint Counts|Assessment of individual ACR core components like Tender Joint Counts (TJC) and Swollen Joint Counts (SJC)|Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)|FAS (Double-blind), Efficacy Analysis Set (Extension)||joint counts||Standard Deviation|Mean
800621|NCT00965848|Secondary|Number of Participants With 90-day Mortality|Number of Participants with 90-day mortality was defined as the number of participants who died by Day 90.|up to Day 90|"The cMITT included all participants who received any dose of study medication and met the clinical definition in the protocol. N” signifies those participants who were evaluated for this measure."||Participants|||Number
800622|NCT00965848|Secondary|Percentage of Participants With Clinical Response at Test-of-Cure (TOC)|Clinical response was defined as cure, improvement, failure and indeterminate. Cure=All signs/symptoms resolved/improved/lack of progression of all abnormalities; Improvement=Signs/symptoms of disease improved/resolved/ no modification in antibiotic therapy required and no worsening/appearance of new signs & symptoms of disease; Failure=Persistence or worsening of signs/symptoms of disease or emergence of new signs/symptoms & require any other antimicrobial therapy; & Indeterminate=Insufficient data for treatment evaluation. The TOC visit (up to Day 14 after EOT) was conducted by phone. Participants who were assessed as cure or improvement at EOT will be evaluated for clinical response at TOC (up to Day 14 after EOT).|Up to Day 14 after End-of-Treatment (EOT)|"The cMITT included all participants who received any dose of study medication. “N signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."||Percentage of Participants|||Number
800623|NCT00965848|Secondary|Percentage of Participants With Clinical Response at End-of-Treatment (EOT)|Clinical response was defined as cure, improvement, failure and indeterminate. Cure=All signs/symptoms resolved/improved/lack of progression of all abnormalities; Improvement=Signs/symptoms of disease improved/resolved/ no modification in antibiotic therapy required & no worsening/appearance of new signs & symptoms of disease; Failure=Persistence or worsening of signs/symptoms of disease or emergence of new signs/symptoms and require any other antimicrobial therapy; and Indeterminate=Insufficient data for treatment evaluation. 2 subjects were lost to follow-up.|Up to Day 14 (EOT)|"Clinical Modified-Intent-to-Treat (cMITT) included all participants who received any dose of study medication. N signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."||Percentage of participants|||Number
800624|NCT00965848|Primary|Number of Participants With Adverse Events (AEs) and Number of Participants Discontinued Because of AEs|An adverse event is any untoward medical occurrence in a participant administered with a pharmaceutical product. An adverse event does not necessarily have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. The number of participants discontinued because of AEs were also reported.|Up to 30 days after last dose of study drug|Intent-to-treat population (ITT) included all participants who received at least one dose of study medication.||Participants|||Number
800625|NCT00966186|Secondary|Insertion Time, Sealing Pressure and Complication||5 min - 4 hours||||||
800626|NCT00966186|Primary|Success of Insertion at First Attempt||5 minute|||participants|||Number
800627|NCT00966238|Secondary|Geometric Mean Hemagglutinin Inhibition (HAI) Antibody Titers||28 days after vaccination|The immunogenicity of the vaccine was evaluated by measuring the number of subjects who demonstrate seroconversion either by developing a measurable titer following vaccination or by showing a significant increase in HAI serum antibody titers post-vaccination.||Titers||95% Confidence Interval|Geometric Mean
800628|NCT00966238|Primary|Number of Participants With Local and Systemic Immediate Reactogenicity Complaints||within 4 hours following vaccination|Immediate complaints were vaccination symptoms that were solicited and observed at 30 minutes (+15 minutes) and (±30 minutes) after the vaccination on Day 0.||Participants|||Number
800629|NCT00966264|Secondary|Depression||baseline, 6 and 12 months, 5 and 10 years||05/2010||||
800630|NCT00966264|Primary|Costs||baseline, 6 and 12 months, 5 and 10 years||05/2010||||
800631|NCT00966264|Primary|HRQoL (Health Related Quality of Life)|HRQoL was measured by the 5-Dimensional EuroQol (EQ-5D) questionnaire which measures HRQoL in 5 dimensions of life (scale 0-1)(from very poor=0 to very good=5). The results are the change of HRQoL from baseline at 5 years (EQ-5D score at 5 years - EQ-5D score at baseline)|baseline and 5 years|The power calculation was made on the basis of an EQ-5D score SD of 19% and alfa=0.05. The study had 80% power to detect a 7.5% difference between the groups||points on a scale||95% Confidence Interval|Mean
800632|NCT00966277|Primary|Number of Participants With Venous Thromboembolic Events (VTE)|Venous thromboembolism (VTE) defined by both symptomatic and asymptomatic VTE which includes deep venous thrombosis (DVT) and pulmonary embolism (PE) through clinical assessments and radiologic studies. All patients undergo bilateral lower extremity ultrasound every 2 months while on study (total of 3 exams including pre-randomization). VTE requires imaging documentation to evaluate use of prophylactic anticoagulation in reducing the occurrence of VTE in a patient population with a known high risk of VTE.|16 weeks of treatment|||participants|||Number
800636|NCT00966550|Primary|IL-6 Concentrations||6 hour postprandial study|Analysis was per-protocol (tomato vs Non-tomato) and no imputations were given for any missing values; missing values treated as a missing.||pg/mL||Standard Error|Least Squares Mean
800637|NCT00966641|Primary|Area Under the Curve of Plasma Naproxen From 0 to t|Blood samples for evaluation of PK variables were collected over a 48-hour period after drug administration.|30 minutes prior to administration; 30, 60, and 90 minutes post drug administration; and 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, and 48 hours post drug administration.|Pharmacokinetic (PK) Evaluable Population consists of the 28 subjects who completed the study with no protocol deviations.||min×μg/mL||Full Range|Mean
800638|NCT00966654|Secondary|Insulin Infusion Requirements||72 hours|The raw study data is not available for this study. The study was terminated early due to the P.I.'s noncompliance with JHU IRB Protocol and he has since left the institution. Significant efforts have been made to locate data, but it is unfortunately unavailable.|||||
800639|NCT00966654|Primary|Left Ventricular Systolic Function: Pulmonary Capillary Wedge Pressure||2 years|The raw study data is not available for this study. The study was terminated early due to the P.I.'s noncompliance with Johns Hopkins University School of Medicine Institutional Review Board Protocol and he has since left the institution. Significant efforts have been made to locate data, but it is unfortunately unavailable.|||||
800640|NCT00966823|Secondary|Number of Participants With In Utero Lung Growth (LHR) >1.4|"Inclusion criterion for the study is LHR<0.9 (extreme pulmonary hypoplasia). Given that LHR is relatively constant during 2nd and 3rd trimester of gestation, In utero lung growth is defined as LHR>1.4 (definition of mild/moderate pulmonary hypoplasia) within 2 weeks of intervention.
Outcome measure = number of participants with LHR>1.4 at 2 weeks post-intervention"|Intervention to 2 weeks post-intervention|||Participants|||Number
800641|NCT00966823|Secondary|Fetal Morbidity|Fetal morbidity, fetal mortality|Intervention to delivery|||Participants|||Number
800645|NCT00966875|Secondary|Percentage of Participants With Anti-LY2439821 Antibodies|Treatment-emergent anti-LY2439821 antibody positive participants were defined as a titer change from baseline that was at least 2 dilutions (4-fold) increase. Participants must have had an assessment to be classified as treatment emergent antibody positive or negative.|Week 16, Week 64|Part A (Week 16) FAS: all randomized participants who received at least 1 dose of study drug with antibody testing performed; Part B (Week 64): All participants from Part A who entered the open-label portion of the study, part B, with baseline and at least 1 post-baseline antibody testing.||percentage of participants|||Number
800646|NCT00966875|Secondary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2439821 at Steady State|Evaluable PK concentrations from all time points, including data from placebo participants who elected active treatment in Part B, were combined and utilized in a population approach to determine the population median estimates and 90% confidence intervals at steady state. Day 0 and Week 6 postdose samples were collected as late as possible during the dosing visit (in other words, the postdose samples were collected at the end of their respective visits).|Predose: Day 0, Day 1 or 2 or 3, Day 7, Weeks 6, 10, 16, 40 and 64 and Postdose: Day 0 and Week 6|All randomized participants who received at least 1 dose of study drug in Part A and had estimable PK data, as well as, participants from Part A who entered the open-label portion of the study, Part B, and had estimable PK data.||nanograms per milliliter (ng/mL)||90% Confidence Interval|Median
800647|NCT00966875|Secondary|Relationship Between Exposure and Response of EULAR28||Through Week 72|Relationship between exposure and response of EULAR 28 analysis was reported in OMs 22 and 23 as percentage of participants in EULAR28 (Parts A and B), respectively. No further analyses were completed for EULAR28.|||||
800648|NCT00966875|Secondary|Relationship Between Exposure and Response of DAS28||Through Week 72|Relationship between exposure and response of DAS28 analysis was reported in OMs 6 and 7 as change from baseline in DAS28 (Parts A and B) respectively. No further analyses were completed for DAS28.|||||
800649|NCT00966875|Secondary|Relationship Between Exposure and Response of ACR20/50/70/N||Through Week 72|Relationship between exposure and response ACR20/50/70/N analysis was reported in OMs 8 and 9, as percentage of participants with ACR 20/50/70 Response (Parts A and B) and OMs 24 and 25 as percentage of participants with ACR-N (Parts A and B) respectively. No further analyses were completed for ACR20/50/70/N.|||||
800650|NCT00966875|Secondary|Relationship Between Exposure and Response of Individual Components of the ACR Core Set||Through Week 72|Relationship between exposure and response in Individual Components (IC) of ACR Core Set analysis was reported in outcome measures (OMs) 10-21 as change from baseline in IC of ACR Core Sets: TJC, SJC, PAAP-VAS, PtGADA-VAS, PhGA-VAS, and CRP (Parts A and B). No further analyses were completed for individual components of ACR Core Set.|||||
800651|NCT00966875|Secondary|Change From Baseline in HAQ-DI - Part B|HAQ-DI was a participant-reported questionnaire that consisted of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do). The highest score for any question in a category was the score of that category unless special aids or devices or help from another person was required. Answers for at least 6 of the 8 disability domains were required to compute the participant's HAQ-DI score. If the participant had scores for fewer than 6 categories, the HAQ-DI score was considered missing. The HAQ-DI score was calculated as the sum of the category scores divided by the number of categories scored, with a possible scores range from 0 to 3. Negative mean changes from baseline indicated improvement.|Baseline, Week 64|All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 HAQ-DI results.||units on a scale||Standard Deviation|Mean
800652|NCT00966875|Secondary|Change From Baseline in HAQ-DI - Part A|HAQ-DI was a participant-reported questionnaire that consisted of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do). The highest score for any question in a category was the score of that category unless special aids or devices or help from another person was required. Answers for at least 6 of the 8 disability domains were required to compute the participant's HAQ-DI score. If the participant had scores for fewer than 6 categories, the HAQ-DI score was considered missing. The HAQ-DI score was calculated as the sum of the category scores divided by the number of categories scored, with a possible scores range of 0 to 3. Negative mean changes from baseline indicated improvement.|Baseline, up to Week 12|Part A FAS: All randomized participants who received at least 1 dose of study drug; LOCF.||units on a scale||Standard Deviation|Mean
800653|NCT00966875|Secondary|Change From Baseline in Duration of Morning Stiffness (Minutes) - Part B|The investigator queried the participants about the duration of morning stiffness in and around their joints and the results (in minutes) were recorded by the investigator. Duration was the time from when the participants woke up to when normal activities could be resumed. Durations recorded as longer than 12 hours (720 minutes) were summarized as 720 minutes. An increase in duration from baseline indicated a joint worsening and a decrease from baseline indicated joint improvement.|Baseline, Week 64|All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 Duration of Morning Stiffness results.||minutes||Standard Deviation|Mean
800654|NCT00966875|Secondary|Change From Baseline in Duration of Morning Stiffness (Minutes) - Part A|The investigator queried the participants about the duration of morning stiffness in and around their joints and the results (in minutes) were recorded by the investigator. Duration was the time from when the participants woke up to when normal activities could be resumed. Durations recorded as longer than 12 hours (720 minutes) were summarized as 720 minutes. An increase in duration from baseline indicated a joint worsening and a decrease from baseline indicated joint improvement.|Baseline, up to Week 12|Part A FAS: All randomized participants who received at least 1 dose of study drug; LOCF.||minutes||Standard Deviation|Mean
800675|NCT00966875|Secondary|Change From Baseline in DAS28 - Part B|DAS28 consisted of a composite score of the following variables: TJC28, SJC28, CRP, and PtGADA-VAS. DAS28 was calculated as: DAS28 − CRP =0.56(square root TJC28) + 0.28(square root SJC28) + 0.36(ln[CRP +1]) + 0.014(VAS) + 0.96. A negative change indicated an improvement.|Baseline, Week 64|All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 DAS28 results.||units on a scale||Standard Deviation|Mean
800655|NCT00966875|Secondary|Change From Baseline in FACIT Fatigue Scale - Part B|The FACIT-Fatigue Scale was a brief participant-reported questionnaire measure of fatigue and consisted of 13 items that assessed tiredness, weakness and difficulty conducting usual activities due to fatigue. Each question was scored on a 5-point scale from 0 (not at all) to 4 (very much). Scores range from 0 to 52, with higher scores indicating greater fatigue. For missing data, scores were prorated using the average of the other answers in the scales as long as more than 50% of the items were answered. A negative change indicated less fatigue.|Baseline, Week 64|All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 FACIT results.||units on a scale||Standard Deviation|Mean
800656|NCT00966875|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale - Part A|The FACIT Fatigue Scale was a brief participant-reported questionnaire measure of fatigue and consisted of 13 items that assessed tiredness, weakness and difficulty conducting usual activities due to fatigue. Each question was scored on a 5-point scale from 0 (not at all) to 4 (very much). Scores range from 0 to 52, with higher scores indicating greater fatigue. For missing data, scores were prorated using the average of the other answers in the scales as long as more than 50% of the items were answered. A negative change indicated less fatigue.|Baseline, up to Week 12|Part A FAS: defined as all data from all randomized participants who received at least 1 dose of study drug LOCF.||units on a scale||Standard Deviation|Mean
800657|NCT00966875|Secondary|ACR-N - Part B|ACR-N was a continuous measure of clinical, laboratory and functional outcomes in RA that characterized the percentage of improvement in RA disease activity from baseline. The index was defined as the lowest of either: the percent change in TJC, the percent change in SJC, or the median percent change of the remaining 5 ACR core criteria: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, and PhGA-VAS. For each criterion, percent change was calculated as: [(post baseline value - baseline value)/baseline value] * 100.|Week 64|All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 ACR-N results.||units on a scale||Standard Deviation|Mean
800658|NCT00966875|Secondary|ACR-N - Part A|ACR-N was a continuous measure of clinical, laboratory and functional outcomes in RA that characterized the percentage of improvement in RA disease activity from baseline. The index was defined as the lowest of either: the percent change in TJC, the percent change in SJC, or the median percent change of the remaining 5 ACR core criteria: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, and PhGA-VAS. For each criterion, percent change was calculated as: [(post baseline value - baseline value) / baseline value] * 100.|Week 12|Part A FAS: All randomized participants who received at least 1 dose of study drug with results at Week 12; LOCF.||units on a scale||Standard Deviation|Mean
800659|NCT00966875|Secondary|Percentage of Participants in EULAR28 - Part B|Assessment of participant's RA by the EULAR that is based on the DAS28 joint count. Participants were categorized as non-responders or responders (moderate responders + good responders). Percentage of participants was calculated as: (number of responders / number of participants) * 100.|Week 64|All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 EULAR28 results.||percentage of participants|||Number
800660|NCT00966875|Secondary|Percentage of Participants in European League Against Rheumatism Responder Index (EULAR) 28 - Part A|Assessment of participant's rheumatoid arthritis (RA) by the EULAR that is based on the DAS 28 joint count. Participants were categorized as non-responders or responders (moderate responders + good responders). Percentage of participants was calculated as: (number of responders / number of participants) * 100.|Week 12|Part A FAS: All randomized participants who received at least 1 dose of study drug; LOCF.||percentage of participants|||Number
800661|NCT00966875|Secondary|Change From Baseline in Individual Components of the ACR Core Set - CRP - Part B|CRP is a biological marker of disease activity. A negative change indicated an improvement in participant's disease activity.|Baseline, Week 64|All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 CRP results.||mg/L||Standard Deviation|Mean
800662|NCT00966875|Secondary|Change From Baseline in Individual Components of the ACR Core Set - CRP - Part A|CRP is a biological marker of disease activity. A negative change indicated an improvement in participant's disease activity.|Baseline, up to Week 12|Part A FAS: All randomized participants who received at least 1 dose of study drug; LOCF.||mg/L||Standard Deviation|Mean
800663|NCT00966875|Secondary|Change From Baseline in Individual Components of the ACR Core Set - PhGA-VAS - Part B|"The investigator gave an overall assessment of the severity of the participant's disease activity. The physician's response was recorded by marking a vertical tick on a 100-mm VAS with the left end (0 mm) marked as no arthritis activity and the right end (100 mm) marked as extremely active arthritis. A negative change indicated a lessening in the severity of the participant's disease activity."|Baseline, Week 64|All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 PhGA-VAS results.||mm||Standard Deviation|Mean
800664|NCT00966875|Secondary|Change From Baseline in Individual Components of the ACR Core Set - PhGA-VAS - Part A|"The investigator gave an overall assessment of the severity of the participants disease activity. The physician's response was recorded by marking a vertical tick on a 100-mm VAS with the left end (0 mm) marked as no arthritis activity and the right end (100 mm) marked as extremely active arthritis. A negative change indicated a lessening in the severity of the participant's disease activity."|Baseline, up to Week 12|Part A FAS: All randomized participants who received at least 1 dose of study drug; LOCF.||mm||Standard Deviation|Mean
800665|NCT00966875|Secondary|Change From Baseline in Individual Components of the ACR Core Set - PtGADA-VAS - Part B|"The participant was asked to give an overall assessment of his/her current arthritis disease activity. The participants response was recorded by marking a vertical tick on a 100-mm VAS with the left end (0 mm) marked as no arthritis activity to the right end (100 mm) marked extremely active arthritis. A negative change indicated an improvement in the participant's assessment of disease activity."|Baseline, Week 64|All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 PtGADA-VAS results.||mm||Standard Deviation|Mean
800666|NCT00966875|Secondary|Change From Baseline in Individual Components of the ACR Core Set - PtGADA-VAS - Part A|"The participant was asked to give an overall assessment of his/her current arthritis disease activity. The participants response was recorded by marking a vertical tick on a 100-mm VAS with the left end (0 mm) marked as no arthritis activity to the right end (100 mm) marked extremely active arthritis. A negative change indicated an improvement in the participant's assessment of disease activity."|Baseline, up to Week 12|Part A FAS: All randomized participants who received at least 1 dose of study drug; LOCF.||mm||Standard Deviation|Mean
800667|NCT00966875|Secondary|Change From Baseline in Individual Components of the ACR Core Set-PAAP-VAS - Part B|"Participants were asked to assess his/her current level of arthritis pain by marking a vertical tick on a 100-mm horizontal VAS with the left end (0 mm) marked as no pain and the right end (100 mm) marked worst possible pain. The scale was administered prior to the TJC and SJC count examinations. Results were expressed in mm measured between the left end of the scale and the crossing point of the vertical line of the tick. A negative change indicated a lessening of the participant's arthritis pain."|Baseline, Week 64|All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 PAAP-VAS results.||mm||Standard Deviation|Mean
800668|NCT00966875|Secondary|Change From Baseline in Individual Components of the ACR Core Set-PAAP VAS - Part A|"Participants were asked to assess his/her current level of arthritis pain by marking a vertical tick on a 100-mm horizontal VAS with the left end (0 mm) marked as no pain and the right end (100 mm) marked worst possible pain. The scale was administered prior to the TJC and SJC count examinations. Results were expressed in mm measured between the left end of the scale and the crossing point of the vertical line of the tick. A negative change indicated a lessening of the participant's arthritis pain."|Baseline, up to Week 12|Part A FAS: All randomized participants who received at least 1 dose of study drug; LOCF.||mm||Standard Deviation|Mean
800669|NCT00966875|Secondary|Change From Baseline in Individual Components of the ACR Core Set-SJC - Part B|SJC was determined by examination of 28 joint that were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint. Swelling secondary to osteoarthrosis was assessed as not swollen, unless there was unmistakable fluctuation. Joint assessments for each participant were performed by the same assessor, when possible, throughout the study to minimize variation. Replaced, ankylosed, or arthrodesed joints were identified by the investigator and were excluded from evaluation during the study. Any joints that required intra-articular injections over the course of the study were excluded from evaluation from the time of the injection to the conclusion of the study. The number of swollen joints ranged from 0-28. A negative change indicated fewer swollen joints.|Baseline, Week 64|All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 SJC results.||swollen joints||Standard Deviation|Mean
800670|NCT00966875|Secondary|Change From Baseline in Individual Components of the ACR Core Set-SJC - Part A|SJC was determined by examination of 28 joint that were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint. Swelling secondary to osteoarthrosis was assessed as not swollen, unless there was unmistakable fluctuation. Joint assessments for each participant were performed by the same assessor, when possible, throughout the study to minimize variation. Replaced, ankylosed, or arthrodesed joints were identified by the investigator and were excluded from evaluation during the study. Any joints that required intra-articular injections over the course of the study were excluded from evaluation from the time of the injection to the conclusion of the study. The number of swollen joints count ranged from 0-28. A negative change indicated fewer swollen joints.|Baseline, up to Week 12|Part A FAS: All randomized participants who received at least 1 dose of study drug; LOCF.||swollen joints||Standard Deviation|Mean
800671|NCT00966875|Secondary|Change From Baseline in Individual Components of the ACR Core Set-TJC - Part B|TJC was determined by examination of 28 joint counts that were assessed for tenderness by pressure and joint manipulation on physical examination. The participant was asked for pain sensations on these manipulations and was watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-non-tender dichotomy. Joint assessments for each participant were performed by the same assessor, when possible, throughout the study to minimize variation. Replaced, ankylosed, arthrodesed joints were identified by the investigator and excluded from evaluation during the study. Any joints that required intra-articular injections during the study were excluded from evaluation from the time of the injection to the conclusion of the study. The number of tender joints ranged from 0-28. A negative change indicated fewer tender joints.|Baseline, Week 64|All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 TJC results.||tender joints||Standard Deviation|Mean
800672|NCT00966875|Secondary|Change From Baseline in Individual Components of the ACR Core Set-TJC - Part A|TJC was determined by examination of 28 joint counts that were assessed for tenderness by pressure and joint manipulation on physical examination. The participant was asked for pain sensations on these manipulations and was watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-non-tender dichotomy. Joint assessments for each participant were performed by the same assessor, when possible, throughout the study to minimize variation. Replaced, ankylosed, arthrodesed joints were identified by the investigator and excluded from evaluation during the study. Any joints that required intra-articular injections during the study were excluded from evaluation from the time of the injection to the conclusion of the study. The number of tender joints ranged from 0-28. A negative change indicated fewer tender joints.|Baseline, up to Week 12|Part A FAS: All randomized participants who received at least 1 dose of study drug; LOCF.||tender joints||Standard Deviation|Mean
800673|NCT00966875|Secondary|Percentage of Participants With of ACR20/50/70 Response - Part B|ACR20 (or ACR50 or ACR70) responders were participants with at least 20% (or 50% or 70% respectively) improvement from baseline TJC, SJC, and at least 3 of the 5 remaining core set measures: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, and PhGA-VAS. Missing values were imputed using NRI. Percentage of participants was calculated as: (number of ACR20 [or ACR50 or ACR70] responders per treatment arm) / (total number of participants per treatment arm) * 100].|Week 64|All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 ACR20/50/70 results.||percentage of participants|||Number
800674|NCT00966875|Secondary|Percentage of Participants With ACR20/50/70 Response - Part A|ACR20 (or ACR50 or ACR70) responders were participants with at least 20% (or 50% or 70%, respectively) improvement from baseline TJC, SJC, and at least 3 of the 5 remaining core set measures: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, and PhGA-VAS. Missing values were imputed using NRI. Percentage of participants was calculated as: (number of ACR20 [or ACR50 or ACR70] responders per treatment arm) / (total number of participants per treatment arm) * 100.|Week 12|Part A FAS: All randomized participants who received at least 1 dose of study drug.||percentage of participants|||Number
800863|NCT00960661|Secondary|Percent of Participants Achieving HbA1c ≤ 6.5%.|Percent of participants achieving HbA1c ≤ 6.5%.|Week 30|Participants included in the analysis = 244 and 263, respectively. These numbers derived from the per protocol population (247 and 263, respectively) with no missing data for this endpoint (244, 263, respectively).||percentage of participants|||Number
800678|NCT00966875|Secondary|Smallest Doses That Achieved 10%, 50%, and 90% of the Maximum Disease Activity Score (DAS) 28 Response in bDMARD-Naive Population|DAS modified included the 28 diarthrodial joint count (DAS28) that consisted of a composite score of the following variables: TJC out of 28 (TJC28), SJC out of 28 (SJC28), CRP [milligrams per liter (mg/L)], and PtGADA on a 0 to 100 millimeter (mm) VAS ranging from 0 mm (no arthritis activity) to 100 mm (extremely active arthritis). DAS28 was calculated as: DAS28 − CRP = 0.56(square root of TJC28) + 0.28(square root of SJC28) + 0.36(ln[CRP +1]) + 0.014(VAS) + 0.96.|Week 12|Part A FAS: All randomized participants who received at least 1 dose of study drug and were bDMARD-naive.||log (dose) mg|||Number
800679|NCT00966875|Secondary|Smallest Doses That Achieve 10%, 50%, and 90% of the Maximum ACR 20 Response in bDMARD-Naive Population|ACR20 responders are participants with at least 20% improvement from baseline for TJC, SJC, and at least 3 of the 5 remaining core set measures: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, and PhGA-VAS. The model used in the dose response analysis was used to estimate the doses that achieved 10%, 50%, and 90% of the maximal drug efficacy. Missing values were imputed using NRI. The log transformed dose was evaluated.|Week 12|Part A FAS: All randomized participants who received at least 1 dose of study drug and were bDMARD-naive.||log (dose) mg|||Number
800680|NCT00966875|Secondary|Percentage of Participants With ACR20 Response in Tumor Necrosis Factor Alpha-Inadequate Responder (TNFα-IR) Population|ACR20 responders were participants with at least 20% improvement from baseline for TJC, SJC, and at least 3 of the 5 remaining core set measures: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, and PhGA-VAS. Missing values were imputed using NRI. Percentage of participants achieving ACR20 response was calculated as: (number of ACR20 responders / number of participants treated) * 100.|Week 12|Part A FAS: All randomized participants who received at least 1 dose of study drug and were TNFα-IR.||percentage of participants|||Number
800681|NCT00966875|Primary|Dose-Response Relationship Measured by the Percentage of Participants With American College of Rheumatology (ACR) 20 Response in bDMARD-Naive Population|ACR20 responders are participants with at least 20% improvement from baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: Health Assessment Questionnaire-Disability Index (HAQ-DI) which measured participants perceived degree of difficulty performing daily activities, C-reactive Protein (CRP), Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), Patient’s Global Assessment of Disease Activity-VAS(PtGADA-VAS), and Physician’s Global Assessment of Disease Activity-VAS (PhGA-VAS). Missing values were imputed using Non-Responder Imputation (NRI). Percentage of participants achieving ACR20 response was calculated as: (number of ACR20 responders / number of participants treated) * 100.|Week 12|Part A FAS: All randomized participants who received at least 1 dose of study drug and were bDMARD-naive.||percentage of participants|||Number
800682|NCT00966940|Secondary|Mean Intraocular Pressure (IOP) at 6:00 PM|Intraocular pressure was measured by Goldmann applanation tonometry.|6 weeks|This reporting group includes all patients randomized to both periods of the study and exposed to both study drugs.||mm Hg||Standard Deviation|Mean
800683|NCT00966940|Secondary|Mean Intraocular Pressure (IOP) at 4:00 PM|Intraocular pressure was measured by Goldmann applanation tonometry.|6 weeks|This reporting group includes all patients randomized to both periods of the study and exposed to both study drugs.||mm Hg||Standard Deviation|Mean
800684|NCT00966940|Secondary|Mean Intraocular Pressure (IOP) at 2:00 PM|Intraocular pressure was measured by Goldmann applanation tonometry.|6 weeks|This reporting group includes all patients randomized to both periods of the study and exposed to both study drugs.||mm Hg||Standard Deviation|Mean
800685|NCT00966940|Secondary|Mean Intraocular Pressure (IOP) at 12:00 PM|Intraocular pressure was measured by Goldmann applanation tonometry.|6 weeks|This reporting group includes all patients randomized to both periods of the study and exposed to both study drugs.||mm Hg||Standard Deviation|Mean
800686|NCT00966940|Secondary|Mean Intraocular Pressure (IOP) at 10:00 AM|Intraocular pressure was measured by Goldmann applanation tonometry.|6 weeks|This reporting group includes all patients randomized to both periods of the study and exposed to both study drugs.||mm Hg||Standard Deviation|Mean
800687|NCT00966940|Secondary|Mean Intraocular Pressure (IOP) at 8:00 AM|Intraocular pressure was measured by Goldmann applanation tonometry.|6 weeks|This reporting group includes all patients randomized to both periods of the study and exposed to both study drugs.||mm Hg||Standard Deviation|Mean
800688|NCT00966940|Primary|Mean Intraocular Pressure (IOP) at 8:00 PM|Intraocular pressure was measured by Goldmann applanation tonometry.|6 weeks|This reporting group includes all patients randomized to both periods of the study and exposed to both study drugs.||mm Hg||Standard Deviation|Mean
800689|NCT00966953|Primary|Plaque Index|Plaque score scale: Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|8 weeks|||Units on a scale||Standard Deviation|Mean
800690|NCT00954187|Primary|Decreased Overall Pain Score as Measured by the Visual Analogue Scale|No data was collected or analyzed. No study procedures were performed.|one month|No subjects were assigned treatment and no study procedures were performed|||||
800691|NCT00954356|Secondary|Treatment Emergent Adverse Events|"Adverse Events were recorded at the time of occurence. Clinically significant findings (if any) in ECG and vital signs assessments and laboratory samples were recorded as adverse events.
Treatment Emergent Adverse Events (TEAEs) are those which either started or worsened following administration of study drug (XPF-001 or placebo)."|48 hours|||Events|||Number
800692|NCT00954356|Secondary|Time to Rescue Medication|The time of administration of rescue medication (if any) was recorded for each subject and the duration since dosing was calculated.|24 hours|||Minutes||95% Confidence Interval|Median
800693|NCT00954356|Secondary|Time to Meaningful Relief|"Onset of analgesia was measured using 2 stopwatches. Both stopwatches were started at the time of dose administration. Stopwatch 1 was pressed by the subject when any pain relief was first perceived (Time to First Perceptible Relief) and stopwatch 2 was pressed by the subject when pain relief became meaningful (Time to Meaningful Relief).
'Meaningful Relief' was defined as when the relief became 'meaningful' to each individual subject, and was not necessarily a complete absence of pain. 'Meaningful Relief' could not occur before 'First Perceptible Relief'."|24 hours|||Minutes||90% Confidence Interval|Median
801151|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin|Subject response to question: did you feel that your skin was hydrated and moisturized while you on your study product? (Yes or No).|Week 8|ITT||Participants|||Number
800694|NCT00954356|Secondary|Time to First Perceptible Relief|Onset of analgesia was measured using 2 stopwatches. Both stopwatches were started at the time of dose administration. Stopwatch 1 was pressed by the subject when any pain relief was first perceived (Time to First Perceptible Relief) and stopwatch 2 was pressed by the subject when pain relief became meaningful (Time to Meaningful Relief).|24 hours|||Minutes||95% Confidence Interval|Median
800695|NCT00954356|Secondary|Summed Pain Intensity Difference (SPID) at 12 Hours Post Dose|"Pain intensity was scored on an 11-point scale (PINRS), (0=no pain - 10=pain as bad as you can imagine). Scores were measured at baseline (after surgery but before dosing) and at multiple timepoints after dosing. At each timepoint, pain intensity difference (PID) was calculated (ie, baseline score minus timepoint score).
SPID12 is an area calculation encompassing time and the PID scores over the 12 hours following dosing. The minimum possible SPID12 value = -120, the maximum possible = 120.
A positive SPID LS Means score implies reduced pain intensity over the corresponding time period."|Baseline to 12 hours post dose|||units on a scale||95% Confidence Interval|Least Squares Mean
800696|NCT00954356|Secondary|Summed Pain Intensity Difference (SPID) at 8 Hours Post Dose|"Pain intensity was scored on an 11-point scale (PINRS), (0=no pain - 10=pain as bad as you can imagine). Scores were measured at baseline (after surgery but before dosing) and at multiple timepoints after dosing. At each timepoint, pain intensity difference (PID) was calculated (ie, baseline score minus timepoint score).
SPID8 is an area calculation encompassing time and the PID scores over the 8 hours following dosing. The minimum possible SPID8 value = -80, the maximum possible = 80.
A positive SPID LS Means score implies reduced pain intensity over the corresponding time period."|Baseline to 8 hours post dose|||units on a scale||95% Confidence Interval|Least Squares Mean
800697|NCT00954356|Secondary|Summed Pain Intensity Difference (SPID) at 6 Hours Post Dose|"Pain intensity was scored on an 11-point scale (PINRS), (0=no pain - 10=pain as bad as you can imagine). Scores were measured at baseline (after surgery but before dosing) and at multiple timepoints after dosing. At each timepoint, pain intensity difference (PID) was calculated (ie, baseline score minus timepoint score).
SPID6 is an area calculation encompassing time and the PID scores over the 6 hours following dosing. The minimum possible SPID6 value = -60, the maximum possible = 60.
A positive SPID LS Means score implies reduced pain intensity over the corresponding time period."|Baseline to 6 hours post dose|||units on a scale||95% Confidence Interval|Least Squares Mean
800698|NCT00954356|Secondary|Summed Pain Intensity Difference (SPID) at 4 Hours Post Dose|"Pain intensity was scored on an 11-point scale (PINRS), (0=no pain - 10=pain as bad as you can imagine). Scores were measured at baseline (after surgery but before dosing) and at multiple timepoints after dosing. At each timepoint, pain intensity difference (PID) was calculated (ie, baseline score minus timepoint score).
SPID4 is an area calculation encompassing time and the PID scores over the 4 hours following dosing. The minimum possible SPID4 value = -40, the maximum possible = 40.
A positive SPID LS Means score implies reduced pain intensity over the corresponding time period."|Baseline to 4 hours post dose|||units on a scale||95% Confidence Interval|Least Squares Mean
800699|NCT00954356|Secondary|Total Pain Relief (TOTPAR) at 12 Hours Post Dose|"A secondary efficacy variable was total pain relief at the 12-hour observation (TOTPAR 12); TOTPAR 12 is an area calculation incorporating time and relief scores over the 12 hours following dosing and was calculated using Simpson's trapezoidal rule.
The higher the LS Means scores, the more pain relief was obtained.
Relief (REL) scores were measured at multiple timepoints after dosing, using a 5 point categorical pain relief rating scale. (None = 0, A Little Relief = 1, Some = 2, A Lot = 3, Complete Relief = 4). The minimum possible TOTPAR 12 score = 0, maximum possible score = 48."|12 hours|||units on a scale||95% Confidence Interval|Least Squares Mean
800700|NCT00954356|Secondary|Total Pain Relief (TOTPAR) at 8 Hours Post Dose|"A secondary efficacy variable was total pain relief at the 8-hour observation (TOTPAR 8); TOTPAR 8 is an area calculation incorporating time and relief scores over the 8 hours following dosing and was calculated using Simpson's trapezoidal rule.
The higher the LS Means scores, the more pain relief was obtained.
Relief (REL) scores were measured at multiple timepoints after dosing, using a 5 point categorical pain relief rating scale. (None = 0, A Little Relief = 1, Some = 2, A Lot = 3, Complete Relief = 4). The minimum possible TOTPAR 8 score = 0, maximum possible score = 32"|8 hours|||units on a scale||95% Confidence Interval|Least Squares Mean
800701|NCT00954356|Secondary|Total Pain Relief (TOTPAR) at 4 Hours Post Dose|"A secondary efficacy variable was total pain relief at the 4-hour observation (TOTPAR 4); TOTPAR 4 is an area calculation incorporating time and relief scores over the 4 hours following dosing and was calculated using Simpson's trapezoidal rule.
The higher the LS Means scores, the more pain relief was obtained.
Relief (REL) scores were measured at multiple timepoints after dosing, using a 5 point categorical pain relief rating scale. (None = 0, A Little Relief = 1, Some = 2, A Lot = 3, Complete Relief = 4). The minimum possible TOTPAR 4 score = 0, maximum possible score = 16)."|4 hours|||units on a scale||95% Confidence Interval|Least Squares Mean
800702|NCT00954356|Primary|Total Pain Relief at 6 Hours Post Dose (TOTPAR 6)|"The primary efficacy variable was total pain relief at the 6-hour observation (TOTPAR 6); TOTPAR 6 is an area calculation incorporating time and relief scores over the 6 hours following dosing and was calculated using Simpson's trapezoidal rule.
The higher the LS Means scores, the more pain relief was obtained.
Relief (REL) scores were measured at multiple timepoints after dosing, using a 5 point categorical pain relief rating scale. (None = 0, A Little Relief = 1, Some = 2, A Lot = 3, Complete Relief = 4). The minimum possible TOTPAR 6 score = 0, maximum possible score = 24"|6 hours post dose|Published data from an impacted wisdom tooth removal was used to determine a 60 subject study with 2:1 randomisation and a one-sided significance level of 0.10 would have a power of 84.1%. LOCF was used for imputed values and all subjects were included in both the IIT and PP populations for analysis.||units on a scale||95% Confidence Interval|Least Squares Mean
800711|NCT00959894|Secondary|Change in Limb and Trunk Fat Distribution as Measured by DEXA Scan, in the Same Subgroup of up to 40 Participants (as in Aim 8), From Baseline to Week 24 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|Changes from baseline to follow-up in limb fat, trunk fat, total body fat, and lean mass were calculated. Whole body Dual X-ray Absorptiometry (DEXA) scans (Hologic Discovery W, Hologic Inc., Bedford, MA) were conducted at baseline, Week 24, and Week 96 to assess body fat distribution. Calculations of change from baseline to follow-up used the value closest to schedule and within the analysis window, and were quantified with the estimated median and distribution-free 95% CI.|Baseline to 24 weeks|This per-protocol sub-study analysis was conducted in the as-treated population of participants in the metabolic sub-study.||percentage of body fat||95% Confidence Interval|Median
800703|NCT00954421|Secondary|Fain-Tolosa-Marin Tremor Rating Scale (TRS) Change Score for Either VIM or VO On, and for Both VIM and VO Off (Baseline Minus 6 Months Post-implant)|"Tremor was evaluated using the Fain-Tolosa-Marin Tremor Rating Scale (TRS). Score was obtained by summing all 21 items, each of which assessed tremor on a scale of 0-4. Because some of the 21 items contained more than one subsection, total maximum score was 144, and minimum score was 0. Higher scores represent worse tremor.
Both VIM and VO stimulators will be turned ON and TRS score at 6 months will be compared to pre-implant (baseline).
Either VO or VIM stimulator will be turned on (as opposed to both stimulators, as in outcome measure 1), and change in Tremor Rating Scale scores will be compared. The effects of each individual stimulator will also be compared to both being turned on."|Baseline to Six Months|Patients completing 6 months were tested for VIM and VO both on vs. both off. Score is TRS scale with both off minus both on. Positive value favors DBS.||units on a scale||Standard Deviation|Mean
800704|NCT00954421|Primary|Fain-Tolosa-Marin Tremor Rating Scale (TRS) Change Score for Both VIM and VO ON (Baseline Minus 6 Months Post-implant)|"Tremor was evaluated using the Fain-Tolosa-Marin Tremor Rating Scale (TRS). Score was obtained by summing all 21 items, each of which assessed tremor on a scale of 0-4. Because some of the 21 items contained more than one subsection, total maximum score was 144, and minimum score was 0. Higher scores represent worse tremor.
Both VIM and VO stimulators will be turned ON and TRS score at 6 months will be compared to pre-implant (baseline)."|Change from Baseline to Six Months|All Subjects completing Period 4||units on a scale||Standard Deviation|Mean
800705|NCT00959894|Secondary|Population Pharmacokinetics of Etravirine 400 mg Once Daily, in Combination With Fixed-dose Emtricitabine-tenofovir Among Treatment-naïve HIV-1 Infected Adults: Etravirine AUC-24 Hours at Steady State|Population pharmacokinetics were calculated using sparse sampling. Plasma concentrations of etravirine measured in samples from participants who provided blood samples at multiple study visits, with variation in sampling times relative to dosing of etravirine used to cover the spectrum of the dosing schedule. Model simulations and fitting were performed with NONMEM ® 7.3. (ICON, plc) and model exploration was performed with Berkeley Madonna (Berkeley, CA, USA)|At or after 4 weeks|57 participants who provided samples at multiple time points relative to etravirine dosing.||ng*hr/mL||Inter-Quartile Range|Median
800706|NCT00959894|Secondary|Population Pharmacokinetics of Etravirine 400 mg Once Daily, in Combination With Fixed-dose Emtricitabine-tenofovir Among Treatment-naïve HIV-1 Infected Adults|Population pharmacokinetics were calculated using sparse sampling. Plasma concentrations of etravirine measured in samples from participants who provided blood samples at multiple study visits, with variation in sampling times relative to dosing of etravirine used to cover the spectrum of the dosing schedule. Model simulations and fitting were performed with NONMEM ® 7.3. (ICON, plc) and model exploration was performed with Berkeley Madonna (Berkeley, CA, USA)|At or after 4 weeks|57 participants who provided samples at multiple time points relative to etravirine dosing.||ng/mL||Inter-Quartile Range|Median
800707|NCT00959894|Secondary|Change in Fat Mass Ratio as Measured by DEXA Scan, in the Same Subgroup of up to 40 Participants (as in Aim 8), From Baseline to Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|Change from baseline to follow-up in fat mass ratio was calculated. Whole body Dual X-ray Absorptiometry (DEXA) scans (Hologic Discovery W, Hologic Inc., Bedford, MA) were conducted at baseline, Week 24, and Week 96 to assess body fat distribution. Fat mass ratio was calculated as the ratio of trunk fat percentage and lower limb fat percentage (% trunk fat mass / % lower limb fat mass). Calculations of change from baseline to follow-up used the value closest to schedule and within the analysis window, and were quantified with the estimated median and distribution-free 95% CI.|Baseline to 96 weeks|This per-protocol sub-study analysis was conducted in the as-treated population of participants in the metabolic sub-study.||ratio of trunk fat % : lower limb fat %||95% Confidence Interval|Median
800708|NCT00959894|Secondary|Pharmacokinetics of Etravirine in Genital Secretions of up to 10 Men and up to 10 Women at Week 4 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|This secondary outcome measure assessed the ratio of semen:plasma concentration of etravirine in paired semen and plasma samples collected from 14 male participants at Week 4 of treatment with etravirine and fixed dose tenofovir/emtricitabine.|4 weeks|Of 79 participants who initiated study medications, 14 provided paired plasma and genital secretion samples. The goal was to enroll a total of 20 participants (10 men and 10 women) into the genital secretion sub-group, however no women enrolled into this subgroup. Data are presented for semen and plasma etravirine concentrations for 14 men.||ratio of semen:plasma drug concentration||Inter-Quartile Range|Median
800709|NCT00959894|Secondary|Change in Fat Mass Ratio as Measured by DEXA Scan, in the Same Subgroup of up to 40 Participants (as in Aim 8), From Baseline to Week 24 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|Change from baseline to follow-up in fat mass ratio was calculated. Whole body Dual X-ray Absorptiometry (DEXA) scans (Hologic Discovery W, Hologic Inc., Bedford, MA) were conducted at baseline, Week 24, and Week 96 to assess body fat distribution. Fat mass ratio was calculated as the ratio of trunk fat percentage and lower limb fat percentage (% trunk fat mass / % lower limb fat mass). Calculations of change from baseline to follow-up used the value closest to schedule and within the analysis window, and were quantified with the estimated median and distribution-free 95% CI.|Baseline to 24 weeks|This per-protocol sub-study analysis was conducted in the as-treated population of participants in the metabolic sub-study.||ratio of trunk fat % : lower limb fat %||95% Confidence Interval|Median
800710|NCT00959894|Secondary|Change in Limb and Trunk Fat Distribution as Measured by DEXA Scan, in the Same Subgroup of up to 40 Participants (as in Aim 8), From Baseline to Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|Changes from baseline to follow-up in limb fat, trunk fat, total body fat, and lean mass were calculated. Whole body Dual X-ray Absorptiometry (DEXA) scans (Hologic Discovery W, Hologic Inc., Bedford, MA) were conducted at baseline, Week 24, and Week 96 to assess body fat distribution. Calculations of change from baseline to follow-up used the value closest to schedule and within the analysis window, and were quantified with the estimated median and distribution-free 95% CI.|Baseline to 96 weeks|This per-protocol sub-study analysis was conducted in the as-treated population of participants in the metabolic sub-study.||percentage of body fat||95% Confidence Interval|Median
800770|NCT00960076|Secondary|Change in 2-hour PPG Following Mixed Meal Tolerance Test (MMTT) From Baseline to Week 18 (LOCF)|Adjusted mean change from baseline in 2-hour PPG (following MMTT) achieved with saxagliptin added on to metformin versus metformin at Week 18 (Randomized Analysis Set). PPG is a continuous measure, the change from baseline for each participant is calculated as the Week 18 value minus the baseline value.|Baseline to week 18|||mg/dL||Standard Error|Mean
800712|NCT00959894|Secondary|Change in Glucose Metabolism (Insulin Resistance), in a Subgroup of up to 40 Participants, From Baseline to Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|Metabolic data analyses were conducted as-treated. Insulin resistance was estimated by the homeostasis model assessment of insulin resistance (HOMA-IR), and was calculated as [fasting insulin (µU/mL) × fasting glucose (mmol/L)]/22.5. Changes from baseline to follow-up were calculated using the value closest to schedule and within the analysis window, and were quantified with the median and inter-quartile range.|Baseline to 96 weeks|This per-protocol sub-study analysis of metabolic outcomes was conducted in the as-treated population in the metabolic sub-study.||µU/ml*mmol/L||Inter-Quartile Range|Median
800713|NCT00959894|Secondary|Change in the Lipid Profile and Glucose Metabolism, in a Subgroup of up to 40 Participants, From Baseline to Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|Metabolic data analyses were conducted as-treated. Changes in total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, triglycerides, and fasting blood glucose from baseline to follow-up were calculated using the value closest to schedule and within the analysis window, and were quantified with the median and inter-quartile range. Insulin resistance was estimated by the homeostasis model assessment of insulin resistance (HOMA-IR), and was calculated as [fasting insulin (µU/mL) × fasting glucose (mmol/L)]/22.5.|Baseline to 96 weeks|This per-protocol sub-study analysis of metabolic outcomes was conducted in the as-treated population in the metabolic sub-study.||mg/dL||Inter-Quartile Range|Median
800714|NCT00959894|Secondary|Change in Glucose Metabolism (Insulin Resistance), in a Subgroup of up to 40 Participants, From Baseline to Week 48 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|Metabolic data analyses were conducted as-treated. Insulin resistance was estimated by the homeostasis model assessment of insulin resistance (HOMA-IR), and was calculated as [fasting insulin (µU/mL) × fasting glucose (mmol/L)]/22.5. Changes from baseline to follow-up were calculated using the value closest to schedule and within the analysis window, and were quantified with the median and inter-quartile range.|Baseline to 48 weeks|This per-protocol sub-study analysis of metabolic outcomes was conducted in the as-treated population in the metabolic sub-study.||µU/ml*mmol/L||Inter-Quartile Range|Median
800715|NCT00959894|Secondary|Change in the Lipid Profile and Glucose Metabolism, in a Subgroup of up to 40 Participants, From Baseline to Week 48 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|Metabolic data analyses were conducted as-treated. Changes in total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, triglycerides, and fasting blood glucose from baseline to follow-up were calculated using the value closest to schedule and within the analysis window, and were quantified with the median and inter-quartile range.|Baseline to 48 weeks|This per-protocol sub-study analysis of metabolic outcomes was conducted in the as-treated population in the metabolic sub-study.||mg/dL||Inter-Quartile Range|Median
800716|NCT00959894|Secondary|Change in Glucose Metabolism (Insulin Resistance), in a Subgroup of up to 40 Participants, From Baseline to Week 24 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|Metabolic data analyses were conducted as-treated. Insulin resistance was estimated by the homeostasis model assessment of insulin resistance (HOMA-IR), and was calculated as [fasting insulin (µU/mL) × fasting glucose (mmol/L)]/22.5. Changes from baseline to follow-up were calculated using the value closest to schedule and within the analysis window, and were quantified with the median and inter-quartile range.|Baseline to 24 weeks|This per-protocol sub-study analysis of metabolic outcomes was conducted in the as-treated population in the metabolic sub-study.||µU/ml*mmol/L||Inter-Quartile Range|Median
800717|NCT00959894|Secondary|Change in the Lipid Profile and Glucose Metabolism, in a Subgroup of up to 40 Participants, From Baseline to Week 24 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|Metabolic data analyses were conducted as-treated. Changes in total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, triglycerides, and fasting blood glucose from baseline to follow-up were calculated using the value closest to schedule and within the analysis window, and were quantified with the median and inter-quartile range.|Baseline to 24 weeks|This per-protocol sub-study analysis of metabolic outcomes was conducted in the as-treated population in the metabolic sub-study.||mg/dL||Inter-Quartile Range|Median
800718|NCT00959894|Secondary|Probability of Remaining Free of a Safety/Tolerability Event at 96 Weeks|The Kaplan-Meier method was used to estimate the proportion of participants ever exposed to etravirine who remained event-free through Week 96, with a 95% CI using Greenwood’s variance estimate and a log-log transformation. Time was handled as continuous (weeks from treatment start to event or censoring).|96 weeks|The analysis population for this outcome is all participants who received at least one dose of etravirine, regardless of whether or not they were still receiving etravirine at the time of the safety/tolerability event.||proportion of participants||95% Confidence Interval|Number
800719|NCT00959894|Secondary|Tolerability of Etravirine in HIV-1 Infected Adults Initiating Antiretroviral Therapy|"The safety/tolerability endpoint was defined as the first grade 3 or higher sign, symptom or laboratory abnormality that was at least one grade higher than baseline among participants ever exposed to etravirine (regardless of treatment status), or permanent discontinuation of etravirine due to any toxicity (regardless of grade). Modification of tenofovir/emtricitabine was not a safety/tolerability event.
The Kaplan-Meier method was used to estimate the proportion of participants ever exposed to etravirine who remained event-free through Week 96, with a 95% CI using Greenwood’s variance estimate and a log-log transformation. Time was handled as continuous (weeks from treatment start to event or censoring)."|96 weeks|The analysis population for this outcome is all participants who received at least one dose of etravirine, regardless of whether or not they were still receiving etravirine at the time of the safety/tolerability event.||participants|||Number
800720|NCT00959894|Secondary|Resistance Mutations in the Subset of Patients With Confirmed Virologic Failure Who Have HIV RNA >500 Copies/mL and Genotype Resistance Results|Per-protocol, genotype testing was conducted at confirmation of virologic failure if the confirmatory HIV-1 RNA was above the laboratory-specified threshold of 500 copies/mL. HIV-1 genotype was determined using the TRUGENE® HIV-1 assay (Siemens Healthcare Diagnostics, Tarrytown, NY)|96 weeks|Of participants with confirmed virologic failure, 8 had HIV-1 RNA levels ≥ 500 copies/mL and 6 of these had viral genotype results available (1 had previously discontinued study medication at Week 2, and 1 was missing).||participants|||Number
807035|NCT01018511|Secondary|Cmaxss of Solifenacin||Week 4, Week 8 and Week 12|"PKAS population. N indicates the number of participants with available data at each timepoint."||ng/mL||Geometric Coefficient of Variation|Geometric Mean
800721|NCT00959894|Secondary|Change in CD4+ Cell Count From Baseline to Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|The per-protocol intention-to-treat analysis of change in CD4+ cell count from baseline to Week 96 was calculated using the measurement closest to schedule and within the analysis window, and quantified with an estimated median and distribution-free 95% CI.|Baseline to 96 weeks|Of 79 participants who initiated study medications, 63 had a Week 48 CD4+ cell count measurement (6 discontinued study participation prior to Week 96 and 10 were lost to follow-up).||cells/uL||95% Confidence Interval|Median
800722|NCT00959894|Secondary|Change in CD4+ Cell Count From Baseline to Week 48 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|The per-protocol intention-to-treat analysis of change in CD4+ cell count from baseline to Week 48 was calculated using the measurement closest to schedule and within the analysis window, and quantified with an estimated median and distribution-free 95% CI.|Baseline to 48 weeks|Of 79 participants who initiated study medications, 69 had a Week 48 CD4+ cell count measurement (4 discontinued study participation prior to Week 48 visit, 3 were lost to follow-up, and 3 missed the Week 48 visit).||cells/uL||95% Confidence Interval|Median
800723|NCT00959894|Secondary|Change in CD4+ Cell Count From Baseline to Week 24 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|The per-protocol analysis of change in CD4+ cell count from baseline to Week 24 was calculated using the measurement closest to schedule and within the analysis window, and quantified with an estimated median and distribution-free 95% confidence interval (CI).|Baseline to 24 weeks|Of 79 participants who initiated study medications, 73 had a Week 24 CD4+ cell count measurement (4 discontinued study participation prior to Week 24,1 missed the Week 24 visit, and 1 did not have a Week 24 CD4+ cell count measurement).||cells/uL||95% Confidence Interval|Median
800724|NCT00959894|Secondary|The Proportion of Participants With HIV RNA <200 Copies/mL at Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|This secondary outcome assessed the proportion of participants who achieved HIV-1 RNA 200 copies/ml at Week 96 of study treatment. The per-protocol analysis was conducted intention-to-treat, with missing evaluations counted as failures.|96 weeks|Of 79 participants who initiated study medications, 63 had a Week 96 HIV-1 RNA measurement (6 participants had discontinued the study and 10 were lost to follow-up). The analysis was conducted intention-to-treat, with missing evaluations counted as failure.||proportion of participants||95% Confidence Interval|Number
800725|NCT00959894|Secondary|The Proportion of Participants With HIV RNA <200 Copies/mL at Week 48 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|This secondary outcome assessed the proportion of participants who achieved HIV-1 RNA <200 copies/ml at Week 48 of study treatment. The per-protocol analysis was conducted intention-to-treat, with missing evaluations counted as failures.|48 weeks|Of 79 participants who initiated study medications, 69 had a Week 48 HIV-1 RNA measurement (4 participants had discontinued the study, 3 were lost to follow-up, and 3 missed the Week 48 visit). The analysis was conducted intention-to-treat, with missing evaluations counted as failure.||proportion of participants||95% Confidence Interval|Number
800726|NCT00959894|Secondary|The Proportion of Participants With HIV RNA <200 Copies/mL at Week 24 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|This secondary outcome assessed the proportion of participants who achieved HIV-1 RNA <200 copies/ml at Week 24 of study treatment. The per-protocol analysis was conducted intention-to-treat, with missing evaluations counted as failures.|24 weeks|Of 79 participants who initiated study medications, 74 had a Week 24 HIV-1 RNA measurement (3 participants had discontinued the study, 1 was lost to follow-up, and 1 missed the Week 24 visit). The analysis was conducted intention-to-treat, with missing evaluations counted as failure.||proportion of participants||95% Confidence Interval|Number
800727|NCT00959894|Secondary|The Proportion of Participants With HIV RNA <50 Copies/mL at Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|This secondary outcome assessed the proportion of participants who achieved HIV-1 RNA <50 copies/ml at Week 96 of study treatment. The per-protocol analysis was conducted intention-to-treat, with missing evaluations counted as failures.|96 weeks|Of 79 participants who initiated study medications, 63 had a Week 96 HIV-1 RNA measurement (6 participants had discontinued the study and 10 were lost to follow-up). The analysis was conducted intention-to-treat, with missing evaluations counted as failure.||proportion of participants||95% Confidence Interval|Number
800728|NCT00959894|Secondary|The Proportion of Participants With HIV RNA <50 Copies/mL at Week 48 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|This secondary outcome assessed the proportion of participants who achieved HIV-1 RNA <50 copies/ml at Week 48 of study treatment. The per-protocol analysis was conducted intention-to-treat, with missing evaluations counted as failures.|48 weeks|Of 79 participants who initiated study medications, 69 had a Week 48 HIV-1 RNA measurement (4 participants had discontinued the study, 3 were lost to follow-up, and 3 missed the Week 48 visit). The analysis was conducted intention-to-treat, with missing evaluations counted as failure.||proportion of participants||95% Confidence Interval|Number
800729|NCT00959894|Primary|The Antiretroviral Activity of Etravirine 400 mg Given Once Daily, With Fixed-dose Truvada Once Daily, Among Treatment-naïve HIV-1 Infected Adults as Measured by the Percentage of Participants With HIV RNA < 50 Copies/mL at Week 24|The primary study endpoint was the proportion of participants who achieved HIV-1 RNA <50 copies/ml at Week 24 of study participation. The per-protocol primary analysis was conducted intention-to-treat, with missing evaluations counted as failures. Achievement of HIV-1 viral load below 50 copies/ml was defined as having HIV-1 RNA <50 copies/ml during the Week 24 analysis window (>18 and <30 weeks post-entry).|24 weeks|Of 79 participants who initiated study medications, 74 had a Week 24 HIV-1 RNA measurement. The primary analysis was conducted intention-to-treat, with missing evaluations counted as failure.||proportion of participants||95% Confidence Interval|Number
800730|NCT00959907|Primary|Horizontal Action Halo Diameter at 112 Days|Minor’s test permits the visualization of the effect of botulinum toxin in the injected area,also called action halos. Mirror is a computer program that allows, through photogrpahs, measuring the horizontal diameter and the area of action halos.|112 days|Intention to treat analysis. 55 volunteers - One drop out from visit 2 (28 days) to visit 3 (112 days): 54 volunteers.||centimeter||Standard Deviation|Mean
800731|NCT00959907|Primary|ECMAP in m. Frontialis BoNT A1(4U) X BoNT A2 (2U)|ECMAP(Evoked Compound Muscle Action Potentials) was accessed by an electromyography (EMG) device (TECA Sapphire - TECA Corp., Pleasantville, NY).|28 days|||microvolts||Standard Deviation|Mean
811708|NCT01059760|Primary|Change From Baseline in Participant Mean Corpuscular Volume (MCV) When Fasting and Fed||Baseline and 3 days|||fL||Standard Deviation|Mean
800732|NCT00959907|Primary|Horizontal Action Halo Diameter at 28 Days|Minor’s test permits the visualization of the effect of botulinum toxin in the injected area,also called action halos. Mirror is a computer program that allows, through photogrpahs, measuring the horizontal diameter and the area of action halos.|28 days|The analysis was intention to treat (ITT); One drop out, from baseline to visit 1(intervention) and 3 drop outs from visit 1 to visit 2 (28 days after botulinum toxin injections). Started 59 volunteers - 4 drop outs, there was 55 volunteers in the first analysis.||centimeter||Standard Deviation|Mean
800733|NCT00959920|Secondary|Difference in Cost Between the Two Interventions|Cost of the intermittent vs. foley catheterization procedures was measured and reported in mean dollars.|End of study.|No formal statistical testing was conducted on these measures as complete financial records were not available for the analysis.|||||
800734|NCT00959920|Primary|Time to Delivery (by Any Route)|Time to delivery defined as IV placement to delivery of infant.|1 day|Our a priori sample size required 138 women (69 per group) for 80% power to detect the clinically relevant 30 minute difference in the time to delivery interval with a .05 alpha error.||Hours||Inter-Quartile Range|Median
800735|NCT00959946|Secondary|Plasma Decay Half-Life (t1/2) - Part 2|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Half-life was to be calculated as 0.693/λz.|0 hour (Pre-dose) on Day 1 and 2, 3, 4, 6, 8 and 24 hours post-dose on Day 14 of Cycle 1|Data was not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.|||||
800736|NCT00959946|Secondary|Terminal-Phase Disposition Rate Constant (λz) - Part 2|The terminal-phase disposition rate constant measured by a log-linear regression of the terminal mono exponential portion of the observed plasma concentrations.|0 hour (Pre-dose) on Day 1 and 2, 3, 4, 6, 8 and 24 hours post-dose on Day 14 of Cycle 1|Data was not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.|||||
800737|NCT00959946|Secondary|Apparent Oral Clearance (CL/F) - Part 2|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|0 hour (Pre-dose) on Day 1 and 2, 3, 4, 6, 8 and 24 hours post-dose on Day 14 of Cycle 1|Data was not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.|||||
800738|NCT00959946|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)] - Part 2|AUC (0-24) = Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-24).|0 hour (Pre-dose) on Day 1 and 2, 3, 4, 6, 8 and 24 hours post-dose on Day 14 of Cycle 1|Data was not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.|||||
800739|NCT00959946|Secondary|Apparent Volume of Distribution (Vz/F) - Part 2|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|0 hour (Pre-dose) on Day 1 and 2, 3, 4, 6, 8 and 24 hours post-dose on Day 14 of Cycle 1|Data was not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.|||||
800740|NCT00959946|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) - Part 2||0 hour (Pre-dose) on Day 1 and 2, 3, 4, 6, 8 and 24 hours post-dose on Day 14 of Cycle 1|Data was not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.|||||
800741|NCT00959946|Secondary|Maximum Observed Plasma Concentration (Cmax) - Part 2||0 hour (Pre-dose) on Day 1 and 2, 3, 4, 6, 8 and 24 hours post-dose on Day 14 of Cycle 1|Data was not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.|||||
800742|NCT00959946|Secondary|Duration of Response (DR) - Part 2|Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Part 2 Baseline, every 6 weeks up to 2 to 6 weeks after last dose|Data was not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.|||||
800743|NCT00959946|Secondary|Clinical Benefit Rate - Part 2|Percent of participants with confirmed CR, PR or SD for at least 24 weeks on study according to RECIST. CR: disappearance of all lesions. PR: at least 30% decrease in sum of LDs of target lesions taking as reference baseline sum LDs. SD: neither sufficient shrinkage for PR nor sufficient increase for PD taking as reference smallest sum of LD since treatment started.|Part 2 Baseline, every 6 weeks up to 2 to 6 weeks after last dose|Data was not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.|||||
800744|NCT00959946|Secondary|Progression Free Survival (PFS) - Part 2|"Time in weeks from randomization to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of randomization plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for PD), or from adverse event (AE) data (where the outcome was Death)."|Part 2 Baseline, every 6 weeks up to 2 to 6 weeks after last dose|Data was not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.|||||
800745|NCT00959946|Secondary|Best Overall Response - Part 1|Best overall response based on investigator's disease status assessment. CR: disappearance of all lesions. PR: at least 30% decrease in sum of LDs of target lesions taking as reference baseline sum LDs. Progressive disease (PD): at least 20% increase in sum of LD of target lesions taking as a reference smallest sum of the recorded LDs since treatment start, or the appearance of 1 or more new lesions. Stable disease (SD): neither sufficient shrinkage for PR nor sufficient increase for PD taking as reference smallest sum of LD since treatment started.|Part 1 Baseline, every 6 weeks up to 6 months|Per protocol (PP) population included participants who received at least 14 doses of bosutinib and at least 10 doses of capecitabine within a 21-day period, had a baseline and at least 1 post-baseline tumor assessment, and had no major protocol violations.||Participants|||Number
800746|NCT00959946|Primary|Percentage of Participants With Objective Response - Part 2|Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST v1.0). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR is defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30 percent (%) decrease in the sum of the longest dimensions (LDs) of the target lesions taking as a reference the baseline sum LDs.|Part 2 Baseline, every 6 weeks up to 2 to 6 weeks after last dose|Data was not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.|||||
800747|NCT00959946|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) - Part 1|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Part 1 Baseline up to 28 days after last dose of study treatment|Safety population: included participants who received at least 1 dose of the study medication.||Percentage of Participants|||Number
800748|NCT00959946|Primary|Maximum Tolerated Dose (MTD) - Part 1|The MTD contour is defined as the dose combinations that achieve a toxicity rate (dose-limiting toxicity [DLT] rate) of less than (<) 1/3. The observed toxicity rates for all the reporting groups (to which at least 1 cohort of participants was allocated) was estimated by calculating the proportion of DLTs observed in the first 21 days of treatment at those reporting groups. DLT includes grade (Gr) 3/4 nausea, vomiting, diarrhea, or asthenia more than 3 days, Gr 4 hematologic toxicities, delayed study treatment administration due to dose toxicities by more than 3 weeks. Pre-defined criterion for MTD: if a higher dose level of capecitabine existed such that the same dose level of bosutinib had a DLT rate of <1/3, no MTD was recommended for that capecitabine dose and if even the lowest dose of bosutinib achieved a toxicity rate of greater than (>) 1/3, no MTD was recommended for that capecitabine dose level.|Part 1 Baseline up to Day 21|DLT evaluable population included all participants who received at least 14 doses of bosutinib and at least 10 doses of capecitabine in the first 21 days of treatment or had experienced a DLT within the first 21 days of treatment. N (number of participants analyzed) signifies participants who were evaluable for this measure.||mg|||Number
800749|NCT00959985|Secondary|To Evaluate the Number of Patients With Low-level Arm Swelling in Order to Understand the Natural History of Lymphedema After Treatment for Breast Cancer|We recorded the number of participants who had low-level arm swelling, as defined by the Relative Volume Change (RVC) equation of >5%-<10%, at the time of their post-operative follow up to determine if women who had low-level arm swelling were more likely to develop lymphedema|5 years|Number and percentage of participants who had low-level arm swelling at their post-operative follow up are documented below||Participants|||Count of Participants
800750|NCT00959985|Secondary|To Identify the Number of Patients With Risk Factors Associated With the Onset of Lymphedema That Are Both Related and Unrelated to Treatment for Breast Cancer|Surgical and radiation therapy risk factors for lymphedema (surgery to lymph nodes, radiation to lymph nodes), as well as risk factors unrelated to breast cancer treatment such as high BMI were collected upon medical record review|5 years|The number and percentage of participants in each group who had at least 2 known risk factors for lymphedema is documented in the outcome measure data table below||Participants|||Count of Participants
800751|NCT00959985|Primary|To Assess Survey Response Scores Regarding Upper Extremity Function as it Associated With Varying Degrees of Lymphedema|Upper extremity functions were assessed through the Lymphedema Evaluation Following Treatment of Breast Cancer (LEFT-BC) survey. Participant responses were scored on a scale from 19-95, where higher score was associated with more difficulty utilizing arm for daily activities (19 = least difficulty; 95 = most difficulty)|5 years|Median scores for the upper extremity function questions on the LEFT-BC survey, per group, are indicated below. Participants who did not complete or return surveys due to non-compliance were excluded from this analysis.||units on a scale||Full Range|Median
800752|NCT00959985|Primary|To Assess Survey Response Scores Regarding Quality of Life as it Associated With Varying Degrees of Lymphedema|Quality of life was assessed through the Lymphedema Evaluation Following Treatment of Breast Cancer (LEFT-BC) survey. Participant responses were scored on a scale from 0-141, where higher score was associated with higher post-operative quality of life (0= worst; 141= best)|5 years|Median scores for the quality of life questions on the LEFT-BC survey, per group, are indicated below. Participants who did not complete or return surveys due to non-compliance were excluded from this analysis.||units on a scale||Full Range|Median
800753|NCT00959985|Primary|To Assess Survey Response Scores Regarding Fear Avoidance Behavior Associated With Varying Degrees of Lymphedema|Fear avoidance behavior was assessed through the Lymphedema Evaluation Following Treatment of Breast Cancer (LEFT-BC) survey. Participant responses were scored on a scale from 7-28, where higher score was associated with higher level of fear of using arm (7= least fear level; 28= most fear level)|5 years|Median scores for the fear avoidance behavior section on the LEFT-BC survey, per group, are indicated below. Participants who did not complete or return surveys due to non-compliance were excluded from this analysis.||units on a scale||Full Range|Median
800754|NCT00959985|Primary|To Assess Survey Response Scores Regarding Symptoms Associated With Varying Degrees of Lymphedema|Symptoms were assessed through the Lymphedema Evaluation Following Treatment of Breast Cancer (LEFT-BC) survey. The responses were scored on a scale from 0-51, where higher score was associated with presence of more symptoms (0=no symptoms, 51 = most symptoms)|5 years|Median scores of the symptom-related questions on the LEFT-BC survey, per group, are indicated below. Participants who did not complete or return surveys due to non-compliance were excluded from this analysis.||units on a scale||Full Range|Median
800771|NCT00960076|Primary|Change in HbA1c Level From Baseline to Week 18 (LOCF)|Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus metformin at Week 18 (Randomized Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 18 value minus the baseline value.|Baseline to week 18|||Percent||Standard Error|Mean
811709|NCT01059760|Primary|Change From Baseline in Participant Platelet Count When Fasting and Fed||Baseline and 3 days|||cells x 10^3/mL||Standard Deviation|Mean
800755|NCT00959985|Primary|To Identify the Number of Patients Who Experienced Reduction in Edema With Compression Garments +/- Night Compression Bandaging for Moderate Volume Lymphedema Due to Breast Cancer Treatment|Participants who are randomized to receive compression treatment with/without night bandaging will have their arm volume measured at regular intervals throughout the study period. Participants' arm volume, as measured by the validated Relative Volume Change (RVC) equation, at the end of the intervention period will be assessed to determine the efficacy of the compression garment intervention and whether or not it was successful in reducing the participants' arm edema to RVC<10%. Data was collected in participants enrolled in Group 2A and 2B only (8 participants total), and the percentage of participants who experienced reduction in edema is reported below.|5 years|This outcome measure was compared between Groups 2A and 2B. No data was collected for Group 1A and 1B as this outcome does not apply to these groups||Participants|||Count of Participants
800756|NCT00959985|Primary|To Identify the Number of Patients Who Experienced Reduction in Edema With Compression Garment Usage for Low Volume Lymphedema Associated With Breast Cancer Treatment|Participants who are randomized to receive compression treatment will have their arm volume measured at regular intervals throughout the study period. Participants' arm volume, as measured by the validated Relative Volume Change (RVC) equation, at the end of the intervention period will be assessed to determine the efficacy of the compression garment intervention and whether or not it was successful in reducing the participants' arm edema to RVC<10%.Data was collected in study participants enrolled in Group 1A and Group 1B only (15 patients total), and the percentage of participants who experienced reduction in edema is reported below.|5 years|This outcome measure was compared between Group 1A (control) and Group 1B (compression garment). No data was collected for this outcome in Groups 2A and 2B||Participants|||Count of Participants
800757|NCT00960063|Secondary|Plasma Level of Insulin-like Growth Factor Binding Protein-3 (IGFBP-3)|The IGFBP-3 protein is secreted into the bloodstream where it binds to IGF-I and IGF-II. High expression levels of this protein promote the growth of several types of tumors and may be predictive of the chances of recovery of the participant. Robatumumab inhibits expression of this protein. Plasma levels of IGFBP-3 were to be analyzed on Day 1 of Cycles 1, 2, 3, 5, and approximately 30 days after the final dose of robatumumab or the standard treatment assigned (whichever was last).|On Day 1 of Cycles 1, 2, 3 and 5, and ~30 days after last dose of study drug (Up to~10.3 months)|All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy. Individual data were collected, but, due to study termination and small numbers of participants, summary data for IGFBP-3 were not produced.|||||
800758|NCT00960063|Secondary|Plasma Level of Insulin-like Growth Factor Binding Protein-2 (IGFBP-2)|The IGFBP-2 protein is secreted into the bloodstream where it binds to IGF-I and IGF-II. High expression levels of this protein promote the growth of several types of tumors and may be predictive of the chances of recovery of the participant. Robatumumab inhibits expression of this protein. Plasma levels of IGFBP-2 were to be analyzed on Day 1 of Cycles 1, 2, 3, 5, and approximately 30 days after the final dose of robatumumab or the standard treatment assigned (whichever was last).|On Day 1 of Cycles 1, 2, 3 and 5, and ~30 days after last dose of study drug (Up to~10.3 months)|All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy. Individual data were collected, but, due to study termination and small numbers of participants, summary data for IGFBP-2 were not produced.|||||
800759|NCT00960063|Secondary|Plasma Level of Insulin-like Growth Factor-2 (IGF-II)|IGF-II is generally produced locally in response to growth hormone from the hypothalamic-pituitary axis. The IGF ligands can promote neoplastic events (cancer growth) through a number of different mechanisms. Robatumumab inhibits IGF ligand binding, IGF-stimulated receptor phosphorylation and human tumor cell proliferation. Plasma levels of IGF-II were to be analyzed on Day 1 of Cycles 1, 2, 3, 5, and approximately 30 days after the final dose of robatumumab or the standard treatment assigned (whichever was last).|On Day 1 of Cycles 1, 2, 3 and 5, and ~30 days after last dose of study drug (Up to~10.3 months)|All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy. Individual data were collected, but, due to study termination and small numbers of participants, summary data for IGF-II were not produced.|||||
800760|NCT00960063|Secondary|Area Under the Curve During a Dosing Interval τ (AUCτ) for Robatumumab|AUCτ was defined as the area under the plasma concentration-time curve during a dosage interval (τ). Blood samples for analysis of robatumumab PK were to be obtained at Cycles 1 and 2 at the following time points: predose, immediately post-infusion, and at 3, 6, 24, 48, 168, 336, and 504 hours post the start time of infusion. For all odd-numbered cycles (Cycle 3 and on) samples were to be obtained at each of the following two time points: predose and immediately postdose of robatumumab. Additionally, PK samples were to be obtained at the Post Study Visits 1 (30 days after last dose of robatumumab or standard treatment and 2 (approximately 4 months after last dose of robatumumab or standard treatment).|Cycles 1 & 2: pre- and post-infusion, and at 3, 6, 24, 48, 168, 336, and 504 hours post start of infusion; then pre-and post-dose in odd-numbered cycles, and Post Study Visits 1 and 2|All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy. Individual data were collected, but, due to study termination and small numbers of participants, summary data for AUCτ were not produced.|||||
800761|NCT00960063|Secondary|Area Under the Curve at the Time of Final Quantifiable Sample (AUCtf) for Robatumumab|AUCtf for robatumumab was defined as the area under the curve at the time of the final quantifiable sample of robatumumab. Blood samples for analysis of robatumumab PK were to be obtained at Cycles 1 and 2 at the following time points: predose, immediately post-infusion, and at 3, 6, 24, 48, 168, 336, and 504 hours post the start time of infusion. For all odd-numbered cycles (Cycle 3 and on) samples were to be obtained at each of the following two time points: predose and immediately postdose of robatumumab. Additionally, PK samples were to be obtained at the Post Study Visits 1 (30 days after last dose of robatumumab or standard treatment and 2 (approximately 4 months after last dose of robatumumab or standard treatment).|Cycles 1 & 2: pre- and post-infusion, and at 3, 6, 24, 48, 168, 336, and 504 hours post start of infusion; then pre-and post-dose in odd-numbered cycles, and Post Study Visits 1 and 2|All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy. Individual data were collected, but, due to study termination and small numbers of participants, summary data for AUCtf were not produced.|||||
800864|NCT00960661|Secondary|Percentage of Participants Achieving HbA1C < 7.0%|Percentage of participants achieving HbA1C < 7.0%|Week 30|Participants included in the analysis = 244 and 263, respectively. These numbers derived from the per protocol population (247 and 263, respectively) with no missing data for this endpoint (244, 263, respectively).||Percentage of participants|||Number
800762|NCT00960063|Secondary|Time to Maximum Observed Concentration (Tmax) of Robatumumab|Tmax was defined as time of Cmax of robatumumab when administered in combination with other treatments. Blood samples for analysis of robatumumab PK were to be obtained at Cycles 1 and 2 at the following time points: predose, immediately post-infusion, and at 3, 6, 24, 48, 168, 336, and 504 hours post the start time of infusion. For all odd-numbered cycles (Cycle 3 and on) samples were to be obtained at each of the following two time points: predose and immediately postdose of robatumumab. Additionally, PK samples were to be obtained at the Post Study Visits 1 (30 days after last dose of robatumumab or standard treatment and 2 (approximately 4 months after last dose of robatumumab or standard treatment).|Cycles 1 & 2: pre- and post-infusion, and at 3, 6, 24, 48, 168, 336, and 504 hours post start of infusion; then pre-and post-dose in odd-numbered cycles, and Post Study Visits 1 and 2|All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy. Individual data were collected, but, due to study termination and small numbers of participants, summary data for Tmax were not produced.|||||
800763|NCT00960063|Secondary|Number of Participants Who Developed Anti-robatumumab Antibodies|The incidence of anti-robatumumab antibodies was to be assessed. Only participants who had a negative pre-treatment sample and a post-treatment sample were considered to be evaluable. If a participant had a single sample considered positive in the anti-robatumumab antibody assay (with the exception of pre-treatment positive participants), then they would be counted as positive in the immunogenicity assessment.|Prior to 1st and 8th doses of robatumumab, ~30 days after last dose of study drug, and 4 months after last dose of study drug (Up to ~13.3 months)|All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy and had a negative pre-treatment sample and a post-treatment sample.||Participants|||Number
800764|NCT00960063|Secondary|Plasma Level of Insulin-like Growth Factor-I (IGF-I)|IGF-I is produced largely by the liver in response to growth hormone from the hypothalamic-pituitary axis. The IGF ligands can promote neoplastic events (cancer growth) through a number of different mechanisms. Robatumumab inhibits IGF ligand binding, IGF-stimulated receptor phosphorylation and human tumor cell proliferation. Plasma levels of IGF-I were to be analyzed on Day 1 of Cycles 1, 2, 3, 5, and approximately 30 days after the final dose of robatumumab or the standard treatment assigned (whichever was last).|On Day 1 of Cycles 1, 2, 3 and 5, and ~30 days after last dose of study drug (Up to~10.3 months)|All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy. Individual data were collected, but, due to study termination and small numbers of participants, summary data for IGF-I were not produced.|||||
800765|NCT00960063|Secondary|Maximum Observed Concentration (Cmax) of Robatumumab|Cmax was defined as the maximum observed serum concentration of robatumumab when administered in combination with other treatments. Blood samples for analysis of robatumumab pharmacokinetics (PK) were to be obtained at Cycles 1 and 2 at the following time points: predose, immediately post-infusion, and at 3, 6, 24, 48, 168, 336, and 504 hours post the start time of infusion. For all odd-numbered cycles (Cycle 3 and on) samples were to be obtained at each of the following two time points: predose and immediately postdose of robatumumab. Additionally, PK samples were to be obtained at the Post Study Visits 1 (30 days after last dose of robatumumab or standard treatment and 2 (approximately 4 months after last dose of robatumumab or standard treatment).|Cycles 1 & 2: pre- and post-infusion, and at 3, 6, 24, 48, 168, 336, and 504 hours post start of infusion; then pre-and post-dose in odd-numbered cycles, and Post Study Visits 1 and 2|All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy. Individual data were collected, but, due to study termination and small numbers of participants, summary data for Cmax were not produced.|||||
800766|NCT00960063|Secondary|Best Overall Response Based on Response Evaluation Criteria in Solid Tumors (RECIST)|All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs were to be identified as target lesions. Data were to be collected at Screening, every 6 weeks and at 30 days after the final dose of robatumumab or the standard treatment assigned (whichever was last). The best overall response was to be the best response recorded from the start of the treatment until disease progression/recurrence. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): >30% decrease in the sum of the longest diameter (LD) of target lesions; Progressive Disease (PD): >20% increase in the sum of the LD of target lesions or the appearance of one or more new lesions; or Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|Screening, every 6 weeks and at ~30 days after last dose of study drug (Up to ~10.3 months)|All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.||Participants|||Number
800767|NCT00960063|Primary|Number of Participants With Dose Limiting Toxicities|Dose-limiting toxicity was defined by the following adverse events (AEs) that were considered possibly or probably related to either robatumumab or to its interaction with the chemotherapy regimen assigned: neutropenia (Grade 4 for >1 week that did not resolve prior to Day 1 of the next cycle; Grade 3-4 neutropenia with Grade ≥2 fever lasting 3 days; neutropenic infection; failure to recover to study entry/eligibility criteria laboratory requirement levels that resulted in a delay of 14 days between treatment cycles), thrombocytopenia (Grade 4 for >1 week that did not resolve prior to Day 1 of the next cycle; Grade 3-4 requiring a platelet transfusion on 2 separate days within a cycle) or all other AEs (Grade ≥3 [any duration] not ameliorable by supportive or symptomatic measures). The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE version 4.0) was to be used to grade AEs.|Up to ~30 days after last dose of study drug (Up to ~10.3 months)|All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.||Participants|||Number
800768|NCT00960076|Secondary|Percent of Subjects Reaching Goal (HbA1c <7%) at Week 18 (LOCF) - Percent of Subjects (1)|Percent of subjects achieving therapeutic response (HbA1c <7.0%) at Week 18 (LOCF) (Randomized analysis set)|Week 18 (LOCF)|||Percentage of Participants|||Number
800769|NCT00960076|Secondary|Change in FPG From Baseline to Week 18 (LOCF)|Adjusted mean change from baseline in FPG achieved with saxagliptin added on to metformin versus metformin at Week 18 (Randomized Analysis Set). FPG is a continuous measure, the change from baseline for each participant is calculated as the Week 18 value minus the baseline value.|Baseline to week 18|||mg/dL||Standard Error|Mean
800865|NCT00960661|Primary|Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 30|Change in HbA1c from baseline following 30 weeks of therapy (i.e. HbA1c at week 30 minus HbA1c at baseline).|Baseline, 30 weeks|Participants analyzed for this endpoint included the per protocol population, 247 and 263, respectively.||percent of hemoglobin||Standard Error|Least Squares Mean
800772|NCT00960115|Secondary|Time to Treatment Failure (TTF)|TTF was defined as the duration from date of randomization to the date of discontinuation of any trial treatment (cyclophosphamide or saline, tecemotide [L-BLP25] or placebo vaccine) for any reason as reported by the Investigator. Participants who had missed 2 consecutive scheduled doses and were subsequently lost to follow-up were considered as treatment failures with event date as date of first missed administration. Participants without event still on treatment at time of analysis were censored on the date of last treatment administration.|Time from randomization to discontinuation of trial treatment, reported between day of first subject randomized in Step 2 (i.e. 03 Feb 2010), until clinical cut-off date (i.e. 01 May 2014).|ITT analysis set included all subjects randomly allocated to a treatment (tecemotide [L-BLP25] or placebo).||Months||95% Confidence Interval|Median
800773|NCT00960115|Secondary|Progression Free Survival (PFS) Time – Investigator Read|PFS time was defined as the duration from randomization to either first observation of objective PD (based on RECIST v1.0) or occurrence of death due to any cause. Participants without event still on treatment at time of analysis, or who stopped treatment for reasons other than PD or PD without radiological confirmed progression, were censored at the last imaging date. Participants without event who were lost to follow-up were censored at the date of lost to follow-up, except if they missed 2 consecutive scheduled doses, in which case they were considered as having disease progression at time of first missed administration.|Time from randomization to disease progression, death or last tumor assessment, reported between day of first subject randomized in Step 2 (i.e. 03 Feb 2010), until clinical cut-off date (i.e. 01 May 2014).|ITT analysis set included all subjects randomly allocated to a treatment (tecemotide [L-BLP25] or placebo).||Months||95% Confidence Interval|Median
800774|NCT00960115|Secondary|Time To Progression (TTP) – Investigator Read|TTP was defined as the time from date of randomization to date of radiological diagnosis of PD (based on Response Evaluation Criteria in Solid Tumors [RECIST] v1.0). In the event that radiological confirmation could not be obtained but participant was withdrawn from trial treatment or died due to disease progression, TTP was measured from date of randomization to the date of discontinuation of trial treatment. Participants without event who died from causes other than disease progression were censored at date of death. Participants without event who were lost to follow-up were censored at the date of lost to follow-up, except if they missed 2 consecutive scheduled doses, in which case they were considered as having disease progression at time of first missed administration. Participants without event with ongoing treatment at time of analysis, or who had stopped treatment for reasons other than PD, were censored on the date of last treatment administration.|Time from randomization to PD, reported between day of first subject randomized in Step 2 (i.e. 03 Feb 2010), until clinical cut-off date (i.e. 01 May 2014).|ITT Analysis Set included all subjects randomly allocated to a treatment (tecemotide [L-BLP25] or placebo).||Months||95% Confidence Interval|Median
800775|NCT00960115|Primary|Overall Survival (OS) Time|OS time was defined as the time from randomization to death. Participants without event were censored at the last date known to be alive or at the clinical cut-off date (01 May 2014), whichever was earlier.|Time from randomization to death or last day known to be alive reported between day of first subject randomized in Step 2 (i.e. 03 Feb 2010), until clinical cut-off date (i.e. 01 May 2014).|ITT analysis set included all subjects randomly allocated to a treatment (tecemotide [L-BLP25] or placebo).||Months||95% Confidence Interval|Median
800776|NCT00960141|Secondary|Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score|Patients completed a validated, self-administered questionnaire, which included 28 questions on a 7-point scale [score 0 (best) to 6 (worst)] across 7 domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. The scores for each domain were averaged, then the scores for the 7 domains were averaged for the overall score.|Baseline and Week 2|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included. No missing values were imputed.||Units on a Scale||95% Confidence Interval|Least Squares Mean
800777|NCT00960141|Secondary|Physician's Global Evaluation of Allergic Rhinitis|An evaluation by the physician, administered at the last visit (or upon discontinuation) using a 7-point scale, of the change in symptoms as compared to the beginning of the study. Responses were assigned numerical values from 0 (very much better) to 6 (very much worse).|Week 2|The primary efficacy analyses were based on the intention-to-treat. Since only 1 measurement was obtained during the treatment period, no missing values were imputed.||Units on a Scale||95% Confidence Interval|Least Squares Mean
800778|NCT00960141|Secondary|Patient's Global Evaluation of Allergic Rhinitis|An evaluation by the patient, administered at the last visit (or upon discontinuation) using a 7-point scale, in answer to a single question regarding the change in symptoms as compared to the beginning of the study. Responses were assigned numerical values from 0 (very much better) to 6 (very much worse).|Week 2 (or upon discontinuation)|The primary efficacy analyses were based on the intention-to-treat. Since only 1 measurement was obtained during the treatment period, no missing values were imputed.||Units on a Scale||95% Confidence Interval|Least Squares Mean
800779|NCT00960141|Secondary|Mean Change From Baseline in Daytime Eye Symptoms Score|Mean change from baseline in Daytime Eye Symptoms scores on a 4-point scale [0(best) to 3(worst)]. The average of the 4 individual eye symptoms scores (tearing, itchy, red, and puffy eyes) was reported as the Daytime Eye Symptoms Score.|Baseline and Week 2|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.||Units on a Scale||95% Confidence Interval|Least Squares Mean
800780|NCT00960141|Secondary|Mean Change From Baseline in Nighttime Symptoms Score|Mean change from baseline in Nighttime Symptoms Score on a 4-point scale [0(best) to 3(worst)]. The average of 3 scores (Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings) was reported as the Nighttime Symptoms Score.|Baseline and Week 2|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.||Units on a Scale||95% Confidence Interval|Least Squares Mean
800795|NCT00960323|Primary|Maximum Plasma Concentration (Cmax) of Colchicine|The maximum or peak concentration that colchicine reaches in the plasma.|serial pharmacokinetic blood samples drawn prior to dosing on Days 1 and 28 and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hours after dose administration.|24 subjects were enrolled in this study. One subject withdrew from the study prior to Period II check in due to a schedule conflict.||pg/mL||Standard Deviation|Mean
800781|NCT00960141|Primary|Mean Change From Baseline in Daytime Nasal Symptoms Score|Mean change from baseline in Daytime Nasal Symptoms score on a 4-point scale [0(best) to 3(worst)]. The average of the 4 individual nasal symptoms scores (Congestion, Rhinorrhea, Itching, and Sneezing) was reported as the Daytime Nasal Symptoms Score.|Baseline and Week 2|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.||Units on a Scale||95% Confidence Interval|Least Squares Mean
800782|NCT00960154|Primary|Histological Metrics: Amount of Overlying Adherent Char on Slide; Damage to Tumor Epithelium; Effect of Electrosurgical Damage on Diagnostic Quality of Lumpectomy Specimen|Overall histological quality score will be a composite of the histological metrics|Intraoperative|An integrity audit found that the data for this study could not be analyzed owing to unverifiable source documentation.|||||
800783|NCT00960154|Secondary|Operative Metrics: Operative Time, Estimated Blood Loss, Skin Scarring||Intraoperatively and 1-2 weeks postoperatively|An integrity audit found that the data for this study could not be analyzed owing to unverifiable source documentation.|||||
800784|NCT00960193|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable colchicine plasma concentration to the elimination rate constant.|Serial pharmacokinetic blood samples drawn immediately prior to colchicine dosing on Days 1 and 18, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hours after colchicine dose administration.|24 subjects were enrolled in this study. One subject was withdrawn due to failure to arrive for the Day 15 orange juice dose. The pharmacokinetic parameter, AUC(0-∞), could not be determined for 1 subject in the Colchicine Alone group and for 2 subjects in the Colchicine with Seville orange juice group.||pg*hr/mL||Standard Deviation|Mean
800785|NCT00960193|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable colchicine concentration (t), as calculated by the linear trapezoidal rule.|Serial pharmacokinetic blood samples drawn immediately prior to colchicine dosing on Days 1 and 18, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hours after colchicine dose administration.|24 subjects were enrolled in this study. One subject was withdrawn due to failure to arrive for the Day 15 orange juice dose.||pg*hr/mL||Standard Deviation|Mean
800786|NCT00960193|Primary|Maximum Plasma Concentration (Cmax) of Colchicine|The maximum or peak concentration that colchicine reaches in the plasma.|serial pharmacokinetic blood samples drawn immediately prior to colchicine dosing on Days 1 and 18, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hours after colchicine dose administration.|24 subjects were enrolled in this study. One subject was withdrawn due to failure to arrive for the Day 15 orange juice dose.||pg/mL||Standard Deviation|Mean
800787|NCT00960206|Secondary|Hip Follow-Up Questionnaire|"A three question follow-up questionnaire was administered annually asking whether the participant is satisfied with the study total hip replacement(THR) (noted as satisfied below); whether they have any study hip pain (noted as no pain below); and whether they have had any surgery on the study hip during the previous year noted as no surgery below)."|6-10 years|Participants may have one or both hips replaced. Number of participants/hips analyzed includes all enrolled. Number of hips with positive three question responses at postoperative periods indicated is included in the outcome results posting. Number of hips available for evaluation is indicated in the results heading by postoperative period.||hips|Hips||Number
800788|NCT00960206|Secondary|Radiographic Evaluation|Failure is defined as progressive femoral radiolucency (RLL) > or = 2mm around entire stem, progressive subsidence > or = 5mm, progressive acetabular radiolucency (RLL) > or = 2 mm around entire cup, or cup migration > or = 3mm.|3-5 and 10 years|Participants may have one or both hips replaced. Number of participants/hips analyzed includes all enrolled. Number of hips demonstrating radiographic failure assessment at postoperative periods indicated is included in the outcome results posting. Number of hips available for evaluation is indicated in the results heading by postoperative period.||hips|Hips||Number
800789|NCT00960206|Secondary|Harris Hip Score|"Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score less than or equal to 79 is considered fair-poor.
90 - 100 = excellent
80 - 89 = good
70 - 79 = fair
0 - 69 = poor"|3-5 and 10 Years|Participants may have one or both hips replaced. Number of participants and hips analyzed include all enrolled. Number of hips with HHS evaluated at postoperative periods indicated is included in the outcome results posting.||hips|Hips||Number
800790|NCT00960206|Primary|Component Revision and Complications|The number of hips in which the study device was removed and replaced with a new component/s is listed. Complications (adverse events) are listed in the adverse event section.|10 years|Number of participants analyzed includes all subjects enrolled.||hips|hips||Number
800791|NCT00960297|Secondary|To Assess Clinical & Pathologic Response Rate, Complete Resection Rate, Toxicity, Progression-free Survival, & Overall Survival.||60 months||||||
800792|NCT00960297|Primary|To Assess 3-year Overall Survival in Patients With Stage IB (>4.0 cm), II, or Select Stage III NSCLC Treated With Preoperative Carboplatin, Paclitaxel, and Bevacizumab Followed by Surgical Resection.||36 months|Study ended early due to slow accrual.|||||
800793|NCT00960323|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. [AUC(0-∞)] was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant for colchicine.|Serial pharmacokinetic blood samples drawn prior to dosing on Days 1 and 28 and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hours after dose administration.|24 subjects were enrolled in this study. One subject withdrew prior to Period II check-in. The pharmacokinetic parameter, AUC(0-∞), could not be determined for 1 subject in the Colchicine Alone group and for 4 subjects in the Colchicine with Atorvastatin group.||pg*hr/mL||Standard Deviation|Mean
800794|NCT00960323|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule for colchicine.|Serial pharmacokinetic blood samples drawn prior to dosing on Days 1 and 28 and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hours after dose administration.|24 subjects were enrolled in this study. One subject withdrew from the study prior to Period II check in due to a schedule conflict.||pg*hr/mL||Standard Deviation|Mean
800798|NCT00960440|Other Pre-specified|Number of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 6|DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = remission.|Month 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.||participants|||Number
800799|NCT00960440|Other Pre-specified|Number of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 3|DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = remission.|Month 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.||participants|||Number
800800|NCT00960440|Other Pre-specified|Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 4.5 and 6|DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0-9.4, higher score=more disease activity. DAS28-3 (CRP) <=3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission.|Month 4.5, 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.||participants|||Number
800801|NCT00960440|Other Pre-specified|Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Week 2, Month 1 and 3|DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0-9.4, higher score=more disease activity. DAS28-3 (CRP) <=3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission.|Week 2, Month 1, 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.||participants|||Number
800802|NCT00960440|Secondary|Work Limitations Questionnaire (WLQ) Score at Month 6|WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (TMS)(5-items); Physical Demands scale (PDS) (6-item); Mental-Interpersonal Demands Scale (MIDS) (9-items); Output Demands Scale (ODS) (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index (WLI), which represented percentage of lost work over time period relative to a normative population, was derived (total score: 0 [no loss] to 100 [complete loss of work]).|Month 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
800803|NCT00960440|Secondary|Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3|WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (TMS)(5-items); Physical Demands scale (PDS) (6-item); Mental-Interpersonal Demands Scale (MIDS) (9-items); Output Demands Scale (ODS) (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index (WLI), which represented percentage of lost work over time period relative to a normative population, was derived (total score: 0 [no loss] to 100 [complete loss of work]).|Baseline, Month 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
800804|NCT00960440|Secondary|Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 6|Work performance of participants on number of days bothered was based on 10-point scale, where higher score indicated lower work performance.|Month 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
800805|NCT00960440|Secondary|Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline and Month 3|Work performance of participants on number of days bothered was based on 10-point scale, where higher score indicated lower work performance.|Baseline, Month 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
800806|NCT00960440|Secondary|Number of Hours Per Day as Assessed RA-HCRU at Month 6|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, hours affected per day and average number of hours missed work per day were reported.|Month 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.||hours per day||Standard Deviation|Mean
822937|NCT01165983|Secondary|Absolute Change in Inflammatory Cytokines and Growth Factors, GM-CSF pg/mL||12 Weeks post-randomization|||pg/mL||Inter-Quartile Range|Median
800807|NCT00960440|Secondary|Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, hours affected per day and average number of hours missed work per day were reported.|Baseline, Month 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.||hours per day||Standard Deviation|Mean
800808|NCT00960440|Secondary|Number of Days as Assessed Using RA-HCRU at Month 6|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends were reported.|Month 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.||days||Standard Deviation|Mean
800809|NCT00960440|Secondary|Number of Days as Assessed Using RA-HCRU at Baseline and Month 3|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends were reported.|Baseline, Month 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.||days||Standard Deviation|Mean
800810|NCT00960440|Secondary|Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.|Month 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.||number of events||Standard Deviation|Mean
800811|NCT00960440|Secondary|Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.|Baseline, Month 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.||number of events||Standard Deviation|Mean
800812|NCT00960440|Secondary|Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6|RA-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, non-medical practitioner, nursing home, hospital, surgery, emergency room(ER) treatment, diagnostic tests, over-night stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score=higher medical cost.|Month 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
800813|NCT00960440|Secondary|Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3|Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost:visit to doctor,non-medical practitioner,nursing home,hospital,surgery,emergency room(ER) treatment,diagnostic tests, over-night stay,home healthcare services, aids/devices used. Indirect costs associated with functional disability:employment status,willingness to work,work disability due to RA,sick leave,part time work,ability to perform chores,chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale;higher score=higher medical cost.|Baseline, Month 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
800814|NCT00960440|Secondary|Euro Quality of Life - 5 Dimensions (EQ-5D) - Health State Profile Utility Score at Month 6|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Month 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
800946|NCT00967005|Primary|Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Urges/Thoughts Subscale|Week 0 corresponds to baseline. Questions 1 through 5 are summed to compute the thoughts/urges subscale. Minimum=0 and maximum=20, with higher scores signifying more severe thoughts/urges.|Week 0|||units on a scale||Standard Deviation|Mean
800815|NCT00960440|Secondary|Euro Quality of Life - 5 Dimensions (EQ-5D)- Health State Profile Utility Score at Baseline, Month 1 and 3|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Month 1, 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
800816|NCT00960440|Secondary|Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 6|FACIT-FS:13-item questionnaire, participant scored each item on a 5-point scale: 0 (not at all) to 4 (very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-FS for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.|Month 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
800817|NCT00960440|Secondary|Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline and Month 3|FACIT-Fatigue Scale (FS):13-item questionnaire, participant scored each item on a 5-point scale: 0 (not at all) to 4 (very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-FS for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.|Baseline, Month 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
800818|NCT00960440|Secondary|Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6|MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not optimal by choosing yes or no. Number of participants with optimal sleep is reported.|Month 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.||participants|||Number
800819|NCT00960440|Secondary|Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1, and 3|MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not optimal by choosing yes or no. Number of participants with optimal sleep is reported.|Baseline, Week 2, Month 1, 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.||participants|||Number
800820|NCT00960440|Secondary|Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6|Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales:sleep disturbance,snoring,awakened short of breath,sleep adequacy,somnolence (range:0-100);sleep quantity (range:0-24),optimal sleep(yes/no), and 9 item index measures of sleep disturbance provide composite scores:sleep problem summary,overall sleep problem.Except adequacy,optimal sleep and quantity,higher scores=more impairment.Scores transformed(actual raw score[RS] minus lowest possible score divided by possible RS range*100);total score range:0-100;higher score=more intensity of attribute.|Month 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
800821|NCT00960440|Secondary|Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3|Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales:sleep disturbance,snoring,awakened short of breath,sleep adequacy,somnolence (range:0-100);sleep quantity (range:0-24),optimal sleep(yes/no), and 9 item index measures of sleep disturbance provide composite scores:sleep problem summary,overall sleep problem.Except adequacy,optimal sleep and quantity,higher scores=more impairment.Scores transformed(actual raw score[RS] minus lowest possible score divided by possible RS range*100);total score range:0-100;higher score=more intensity of attribute.|Baseline, Week 2, Month 1, 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
800822|NCT00960440|Secondary|36-Item Short-Form Health Survey (SF-36) at Month 6|SF-36 is a standardized survey evaluating 8 domains (of 2 components; physical and mental) of functional health and well being: physical and social functioning, physical and emotional role (role-physical, role-emotional) limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Month 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
800823|NCT00960440|Secondary|36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3|SF-36 is a standardized survey evaluating 8 domains (of 2 components; physical and mental) of functional health and well being: physical and social functioning, physical and emotional role (role-physical, role-emotional) limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline, Week 2, Month 1, 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
800824|NCT00960440|Secondary|Physician Global Assessment of Arthritis at Month 4.5 and 6|Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.|Month 4.5, 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
800825|NCT00960440|Secondary|Physician Global Assessment of Arthritis at Baseline, Week 2, Month 1 and 3|Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.|Baseline, Week 2, Month 1, 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
800826|NCT00960440|Secondary|Patient Global Assessment (PtGA) of Arthritis Pain at Month 4.5 and 6|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly."|Month 4.5, 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
800827|NCT00960440|Secondary|Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1 and 3|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly."|Baseline, Week 2, Month 1, 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
800828|NCT00960440|Secondary|Patient Assessment of Arthritis Pain at Month 4.5 and 6|Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.|Month 4.5, 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
800829|NCT00960440|Secondary|Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1 and 3|Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.|Baseline, Week 2, Month 1, 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
800830|NCT00960440|Secondary|Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 4.5 and 6|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3:0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3:0=least difficulty and 3=extreme difficulty.|Month 4.5, 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
800831|NCT00960440|Secondary|Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, Month 1 and 3|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3:0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3:0=least difficulty and 3=extreme difficulty.|Week 2, Month 1, 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
800832|NCT00960440|Secondary|Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 6|DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = remission.|Month 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
800833|NCT00960440|Secondary|Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline and Month 3|DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = remission.|Baseline, Month 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
800834|NCT00960440|Secondary|Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 4.5 and 6|DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission.|Month 4.5, 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
800835|NCT00960440|Secondary|Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1 and 3|DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) <=3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission.|Baseline, Week 2, Month 1, 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
800836|NCT00960440|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 4.5 and 6|ACR70 response: >=70% improvement in TJC or SJC and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Month 4.5, 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Missing values due to participant dropping due to any reason were imputed using NRI. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.||percentage of participants|||Number
800837|NCT00960440|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 2, Month 1 and 3|ACR70 response: >=70% improvement in TJC or SJC and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 2, Month 1, 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Missing values due to participant dropping due to any reason were imputed using NRI. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.||percentage of participants|||Number
800838|NCT00960440|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 4.5 and 6|ACR50 response: >= 50% improvement in TJC or SJC and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Month 4.5 and 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Missing values due to participant dropping due to any reason were imputed using NRI. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.||percentage of participants|||Number
800839|NCT00960440|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 2, Month 1 and 3|ACR50 response: >= 50% improvement in TJC or SJC and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 2, Month 1, 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Missing values due to participant dropping due to any reason were imputed using NRI. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.||percentage of participants|||Number
800840|NCT00960440|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 4.5 and 6|ACR20 response: >=20% improvement in TJC; >=20% improvement in SJC; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Month 4.5, 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Missing values due to participant dropping due to any reason were imputed using NRI. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.||percentage of participants|||Number
800841|NCT00960440|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 2 and Month 1|ACR20 response: >=20% improvement in TJC; >=20% improvement in SJC; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 2, Month 1|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Missing values due to participant dropping due to any reason were imputed using NRI. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.||percentage of participants|||Number
800842|NCT00960440|Primary|Percentage of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 3|DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, erythrocyte sedimentation rate (ESR)(millimeter/hour [mm/hour]) and patient's global assessment (PtGA) of disease activity (participant rated arthritis activity assessment). Total score range:0-9.4, higher score=more disease activity. DAS28-4 (ESR) less than or equal to (<=)3.2 implied low disease activity, greater than (>)3.2 to 5.1 implied moderate to high disease activity, less than (<)2.6=remission. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis.|Month 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Missing values due to participant dropping due to any reason were imputed using NRI. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.||percentage of participants|||Number
800843|NCT00960440|Primary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities:dress/groom;arise;eat; walk;reach;grip; hygiene;common activities over past week. Each item scored on 4-point scale from 0-3:0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3:0=least difficulty and 3=extreme difficulty. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis.|Baseline, Month 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.||Units on a scale||Standard Deviation|Mean
800844|NCT00960440|Primary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 3|ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joints count (TJC); >= 20% improvement in swollen joints count (SJC); and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP). For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis.|Month 3|Full Analysis Set(FAS):all randomized participants who received at least 1 dose of study treatment, had at least 1 post-baseline measurement. Missing values due to participant dropping due to any reason were imputed using Non-Responder Imputation(NRI). 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.||percentage of participants|||Number
800845|NCT00960531|Other Pre-specified|Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104|The lower limit of quantification (LLOQ) was 100 U/mL and when the assay result was below LLOQ (100 U/mL), 50 U/mL was imputed for IgG.|Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104|The immunogenicity population included all randomized participants with documented injection of at least one dose of study drug and at least one immunogenicity data point collected.||U/ml||95% Confidence Interval|Geometric Mean
800846|NCT00960531|Primary|Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs)|An AE was any untoward, undesired, or unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study drug or in a sponsor’s clinical study. The event did not need to be causally related to the study drug or the clinical studies. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|24 months|All participants who received at least one dose of the study drug were included in the safety population. For safety analyses, the participants were summarized according to the combination of treatments they actually received during the 3134K1-200-EU or 3134K1-2201-US lead-in studies and 3134K1-2203-EU or 3134K1-2205-US extension studies.||percentage of participants|||Number
800847|NCT00960531|Other Pre-specified|Change From Baseline GMTs of Anti-A-beta IgG Subtypes Using ELISA at Visits Where an IgG Total Response is Measurable (at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104 if Applicable)|IgG subtypes were not assessed|Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104|IgG subtypes were not assessed.|||||
800848|NCT00960531|Other Pre-specified|GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104|IgM was not statistically analyzed.|Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104|IgM was not assessed.|||||
800849|NCT00960570|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. [AUC(0-∞)] was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant for efavirenz.|serial pharmacokinetic blood samples drawn immediately prior to dosing on Days 1 and 31 and then 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 48, 72, 96 and 120 hours after dose administration|30 subjects were exposed to study drugs. A total of 6 subjects withdrew. One of those 6 subjects completed all dosing of study medications but withdrew consent prior to the 8 hour post-dose activities on Day 31.||ng-hr/mL||Standard Deviation|Mean
800850|NCT00960570|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule for efavirenz.|serial pharmacokinetic blood samples drawn prior to dosing on Days 1 and 31 and then 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 48, 72, 96 and 120 hours after dose administration|30 subjects were exposed to study drugs. A total of 6 subjects withdrew. One of those 6 subjects completed all dosing of study medications but withdrew consent prior to the 8 hour post-dose activities on Day 31.||ng-hr/mL||Standard Deviation|Mean
805180|NCT00995566|Primary|Duration of Exposure to Thelin|Time between the first and last dose of Thelin. For participants who continued Thelin from TOPS (another study), the initial TOPS’ Thelin start date was used.|1 Year|FAS||months||Standard Deviation|Mean
800851|NCT00960570|Primary|Maximum Plasma Concentration (Cmax) of Efavirenz|The maximum or peak concentration that efavirenz reaches in the plasma.|serial pharmacokinetic blood samples drawn prior to dosing on Days 1 and 31 and then 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 48, 72, 96 and 120 hours after dose administration.|30 subjects were enrolled in this study. A total of 6 subjects withdrew. One of those 6 subjects completed all dosing of study interventions but withdrew consent prior to the 8 hour post-dose activities on Day 31.||ng/mL||Standard Deviation|Mean
800852|NCT00960622|Primary|Change in Peak Oxygen Uptake.|change or difference in peak oxygen uptake after switching from zidovudine-based therapy, such as combivir or trizivir, to tenofovir, versus continuing on zidovudine-based therapy.The difference in peak oxygen uptake were calculated by subtracting peak oxygen uptake values at baseline from the peak oxygen uptake values after 6 months of study intervention. The changes were analyzed within each group and between groups.|baseline and 6 months|||ml/Kg/min||Standard Deviation|Mean
800853|NCT00960661|Secondary|Minor Hypoglycemia Rate Per Year|Mean (standard deviation) of minor hyperglycemia episodes experienced per year. Rates per year were calculated for each individual as the number of episodes divided by the total number of days in the study (from randomization to last visit date), then multiplied by 365.25. Minor hypoglycemia was defined as any time a participant feels that he or she is experiencing a sign or symptom associated with hypoglycemia that is either self-treated by the participant or resolves on its own AND has a concurrent finger stick blood glucose <3.0 mmol/L (54 mg/dL)|30 weeks|The As-treated population includes all randomized participants who had taken at least one dose of study drug.||rate per year||Standard Deviation|Mean
800854|NCT00960661|Secondary|Major Hypoglycemia Rate Per Year|Mean (standard deviation) of major hyperglycemia episodes experienced per year. Rates per year were calculated for each individual as the number of episodes divided by the total number of days in the study (from randomization to last visit date), then multiplied by 365.25. Major hypoglycemia was defined as any symptoms consistent with hypoglycemia resulting in loss of consciousness or seizure that shows prompt recovery in response to administration of glucagon or glucose OR documented hypoglycemia (blood glucose <3.0 mmol/L [54 mg/dL]) and requiring the assistance of another person because of severe impairment in consciousness or behavior.|30 weeks|The As-treated population includes all randomized participants who had taken at least one dose of study drug.||rate per year||Standard Deviation|Mean
800855|NCT00960661|Secondary|Daily Insulin Glargine Dose at Baseline and at Week 30|Daily Insulin Glargine Dose at baseline and at Week 30|Baseline, week 30|Participants analyzed were from the per protocol population (247, 263) with no missing data for this endpoint (247, 263, respectively).||IU/day||Standard Deviation|Mean
800856|NCT00960661|Secondary|Change in Diastolic Blood Pressure (DBP) From Baseline to Week 30|Change in Diastolic Blood Pressure (DBP) from baseline to Week 30 using MMRM model.The model included the respective baseline outcome as covariate, treatment, country, prior use of SUs, week of visit, and treatment-by-week interaction as fixed effects and patient and error as random effects.|baseline, Week 30|Participants included in the analysis = 207 and 227, respectively. These numbers derived from the per protocol population (247 and 263, respectively) with no missing data for this endpoint (207, 227, respectively).||mmHg||Standard Error|Least Squares Mean
800857|NCT00960661|Secondary|Change in Systolic Blood Pressure (SBP) From Baseline to Week 30|Change in Systolic Blood Pressure (SBP) from baseline to Week 30 using MMRM model.The model included the respective baseline outcome as covariate, treatment, country, prior use of SUs, week of visit, and treatment-by-week interaction as fixed effects and patient and error as random effects.|Baseline, Week 30|Participants included in the analysis = 207 and 227, respectively. These numbers derived from the per protocol population (247 and 263, respectively) with no missing data for this endpoint (207, 227, respectively).||mmHg||Standard Error|Least Squares Mean
800858|NCT00960661|Secondary|Change in Body Weight From Baseline to Week 30.|Change in body weight from baseline to Week 30 using MMRM model.The model included the respective baseline outcome as covariate, treatment, country, prior use of SUs, week of visit, and treatment-by-week interaction as fixed effects and patient and error as random effects.|baseline, week 30|Participants analyzed were 247 and 263, respectively. These were from the per protocol population (247, 263, respectively) with no missing data (247, 263, respectively).||kg||Standard Error|Least Squares Mean
800859|NCT00960661|Secondary|Change in Low Density Lipoprotein (LDL) From Baseline to Week 30|Change in Low Density Lipoprotein (LDL) from baseline to week 30 using ANCOVA model.The model included the respective secondary outcome as dependent variable, country, prior use of SU's and treatment groups as factors, and the respective outcomes baseline value as a covariate.|Baseline, Week 30|Participants included in the analysis = 232 and 245, respectively. These numbers derived from the per protocol population (247 and 263, respectively) with no missing data for this endpoint (232, 245, respectively).||mmol/L||Standard Error|Least Squares Mean
800860|NCT00960661|Secondary|Change in High Density Lipoprotein (HDL) From Baseline to Week 30|Change in High Density Lipoprotein (HDL) from baseline to Week 30 using ANCOVA model.The model included the respective secondary outcome as dependent variable, country, prior use of SU's and treatment groups as factors, and the respective outcomes baseline value as a covariate.|Baseline, week 30|Participants included in the analysis = 237 and 254, respectively. These numbers derived from the per protocol population (247 and 263, respectively) with no missing data for this endpoint (237, 254, respectively).||mmol/L||Standard Error|Least Squares Mean
800861|NCT00960661|Secondary|Change in Total Cholesterol From Baseline to Week 30|Change in total cholesterol from baseline to Week 30 using ANCOVA model. The model included the respective secondary outcome as dependent variable, country, prior use of SU's and treatment groups as factors, and the respective outcomes baseline value as a covariate.|Baseline, week 30|Participants included in the analysis = 237 and 254, respectively. These numbers derived from the per protocol population (247 and 263, respectively) with no missing data for this endpoint (237, 254, respectively).||mmol/L||Standard Error|Least Squares Mean
800862|NCT00960661|Secondary|Change in Fasting Blood Glucose (FBG) From Baseline to Week 30.|Change in fasting blood glucose (FBG) from Baseline to Week 30 using MMRM model. The model included the respective baseline outcome as covariate, treatment, country, prior use of SUs, week of visit, and treatment-by-week interaction as fixed effects and patient and error as random effects.|Baseline, Week 30|Participants included in the analysis = 243 and 262, respectively. These numbers derived from the per protocol population (247 and 263, respectively) with no missing data for this endpoint (243, 262, respectively).||mmol/L||Standard Error|Least Squares Mean
800866|NCT00960687|Primary|The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞)|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.|Pharmacokinetic analyses are based on 47 out of 54 enrolled subjects who completed this study.||ng-hr/mL||Standard Deviation|Mean
800867|NCT00960687|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.|Pharmacokinetic analyses are based on 47 out of 54 enrolled subjects who completed this study.||ng-hr/mL||Standard Deviation|Mean
800868|NCT00960687|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that the drug reaches in the plasma.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.|Pharmacokinetic analyses are based on 47 out of 54 enrolled subjects who completed this study.||ng/mL||Standard Deviation|Mean
800869|NCT00960843|Secondary|Rate of Weight Loss kg/wk at Day 180|Rate of weight loss = (screening weight (kg) – weight at Day 180 visit (kg)) / (number of days between screening and Day 180 visit / 7).|Screening to Day 180|Per Protocol population||kg/week||Standard Deviation|Mean
800870|NCT00960843|Secondary|Mean Static Intraband Pressure at Day 180|Mean static Intraband Pressure will be automatically calculated by the Pressure Recording System as the sum of all pressure points divided by the number of seconds X 10 (10Hz data acquisition)|Day 180|Per Protocol population. Note, one subject in the Intraband pressure arm did not provide static intraband pressure measurements at Day 180 and is thus excluded from the analysis.||mmHg||Standard Deviation|Mean
800871|NCT00960843|Primary|Percent Excess Weight Change at Day 180|Percent Excess Weight Change will be calculated per subject as 100% times the difference between screening and Day 180 visit weight divided by the difference between screening weight and ideal body weight for a given sex and height of a subject. Excess weight is defined as the Screening Weight minus the ideal body weight. Ideal body weight is taken from the 1983 Metropolitan Life using the upper limit value of the medium frame range.|Screening to Day 180|Per Protocol Population - all randomized subjects without major protocol violations affecting the validity of pressure or non-pressure data.||percentage of excess weight at screening||Standard Deviation|Mean
800872|NCT00960856|Primary|The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞)|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.|Pharmacokinetic analyses of fenofibric acid are based on 34 subjects who completed the study. One subject discontinued due to an adverse event and two subjects discontinued for personal reasons.||ng-hr/mL||Standard Deviation|Mean
800873|NCT00960856|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic blood samples drawn immediately prior to dosing and then 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours after dose administration|Pharmacokinetic analyses of fenofibric acid are based on 34 subjects who completed the study. One subject discontinued due to an adverse event and two subjects discontinued for personal reasons.||ng-hr/mL||Standard Deviation|Mean
800874|NCT00960856|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that the drug reaches in the plasma.|serial pharmacokinetic blood samples drawn immediately prior to dosing and then 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours after dose administration|Pharmacokinetic analyses of fenofibric acid are based on 34 subjects who completed the study. One subject discontinued due to an adverse event and two subjects discontinued for personal reasons.||ng/mL||Standard Deviation|Mean
800875|NCT00960869|Secondary|The Number of Participants With Heartburn Resolution at 6 Months, i.e. no Heartburn Symptoms During the Last 7 Days Prior to the Visit|"Subjects were asked whether heartburn symptoms within the 7 days prior to the visit were:
none: no symptoms
mild: awareness of symptom, but easily tolerated
moderate: discomforting symptom sufficient to cause interference with normal activities (including sleep)
severe: incapacitating symptom, with inability to perform normal activities (including sleep) Heartburn was defined as a burning feeling rising from the stomach or lower part of the chest towards the neck."|6 months|Intent to Treat (ITT) Population||participants|||Number
800876|NCT00960869|Secondary|The Number of Participants Discontinuing From the Study Due to NSAID-Associated Upper GI Adverse Events|The Number of Participants Discontinuing from the Study Due to non-steroidal anti-inflammatory drug (NSAID)-Associated Upper GI Adverse Events during the treatment period|6 months|Intent to Treat (ITT) Population||participants|||Number
800877|NCT00960869|Secondary|The Number of Subjects With “Treatment Success”|Those Subjects Without Gastric Ulcers and Without Upper Gastrointestinal (UGI) Adverse Events leading to discontinuation.|6 months|Intent to Treat (ITT) Population||participants|||Number
800878|NCT00960869|Secondary|The Number of Participants With Gastric and/or Duodenal Ulcers|The Number of Participants with Gastric and/or Duodenal Ulcers throughout 6 months of treatment.|6 months|Intent to Treat (ITT) Population||participants|||Number
800879|NCT00960869|Primary|Number of Participants With Gastric Ulcer Confirmed by Endoscopy|The primary efficacy endpoint was the number of subjects with gastric ulcers at any time throughout 6 months of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter (measured by close application of open endoscopic biopsy forceps) with unequivocal crater depth. A subject is considered to have completed the study if all scheduled assessments up through the 6 month visit have been performed or if the endpoint of gastric ulcer confirmed by endoscopy has been reached.|6 months|Intent to Treat (ITT) Population||participants|||Number
800880|NCT00960934|Secondary|LS Mean Percent Change From Baseline to Month 6 in Serum Osteocalcin|Serum osteocalcin is a biomarker of bone formation and is measured using units of nanograms (ng) / milliliter (mL).|Baseline and Month 6|Per Protocol population; defined as the subset of the APaT population that excluded participants based on critical protocol violations.||percent change||95% Confidence Interval|Least Squares Mean
800881|NCT00960934|Secondary|LS Mean Percent Change From Baseline to Month 6 in Serum Procollagen Type I N-Terminal Propeptide (P1NP)|Measurement of P1NP appears to be a sensitive marker of bone formation rate in the assessment of osteoporosis.|Baseline to Month 6|The 'Per Protocol' population was used for this analysis. The Per-Protocol population was defined as a subset population that excluded participants based on critical protocol violations.||percent change||95% Confidence Interval|Least Squares Mean
800882|NCT00960934|Secondary|LS Mean Percent Change From Baseline to Month 6 in Serum Bone-Specific Alkaline Phosphatase (s-BSAP)|Bone Specific Alkaline Phosphatase is a biomarker of bone formation and is measured in units of microgram (μg)/liter (L).|Baseline and Month 6|Per Protocol population; defined as the subset of the APaT population that excluded participants based on critical protocol violations.||percent change||95% Confidence Interval|Least Squares Mean
800883|NCT00960934|Secondary|LS Mean Percent Change From Baseline to Month 6 in Serum C-Terminal Telopeptide Collagen I (s-CTx)|C-Terminal Telopeptide Collagen I is used as a serum-marker of bone resorption in the assessment of osteoporosis.|Baseline to Month 6|Per Protocol population; defined as the subset of the APaT population that excluded participants based on critical protocol violations.||percent change||95% Confidence Interval|Least Squares Mean
800884|NCT00960934|Secondary|LS Mean Percent Change From Baseline to Month 6 in the Ratio of Urinary N-Telopeptides of Type I Collagen to Creatinine (u-NTx/Cr)|The ratio of u-NTx to Cr is a biomarker for bone resorption. It is measured in the serum in units of nanomoles (nm) of bone collagen equivalents (BCE)/millimoles of creatinine (Cr).|Baseline and Month 6|Per Protocol population; defined as the subset of the APaT population that excluded participants based on critical protocol violations.||percent change||95% Confidence Interval|Least Squares Mean
800885|NCT00960934|Secondary|LS Mean Percent Change From Baseline to Month 6 in Trabecular Volumetric BMD of the Lumbar Spine|Quantitative computed tomography (QCT) technology was used at baseline and periodically through out the study to assess and measure bone mineral content volumetrically (ie, in grams of tissue per centimeter of tissue cubed).|Baseline and Month 6|Full Analysis Set (FAS); participants who received at least one dose of study treatment, had post-randomization data subsequent to at least one dose of study treatment, and who had baseline data.||percent change||95% Confidence Interval|Least Squares Mean
800886|NCT00960934|Secondary|LS Mean Percent Change From Baseline to Month 6 in Trabecular Volumetric BMD of the Hip|Quantitative computed tomography (QCT) technology was used to assess and measure bone mineral content volumetrically (ie, in grams of tissue per centimeter of tissue cubed).|Baseline and Month 6|Full Analysis Set (FAS); participants who received at least one dose of study treatment, had post-randomization data subsequent to at least one dose of study treatment, and who had baseline data.||percent change||95% Confidence Interval|Least Squares Mean
800887|NCT00960934|Secondary|LS Mean Percent Change From Baseline to Month 6 in Distal One-third Forearm Areal BMD|"DXA was used to assess and measure aBMD of the distal 1/3 forearm. Areal BMD was measured as areal density using units of gram (gm) of tissue /centimeter of tissue squared (cm^2)."|Baseline and Month 6|Full Analysis Set (FAS); participants who received at least one dose of study treatment, had post-randomization data subsequent to at least one dose of study treatment, and who had baseline data.||percent change||95% Confidence Interval|Least Squares Mean
800888|NCT00960934|Secondary|LS Mean Percent Change From Baseline to Month 6 in Total Body aBMD|"DXA was used to assess and measure aBMD of the total body. Areal BMD was measured as areal density using units of gram (gm) of tissue /centimeter of tissue squared (cm^2)."|Baseline and Month 6|Full Analysis Set (FAS); participants who received at least one dose of study treatment, had post-randomization data subsequent to at least one dose of study treatment, and who had baseline data.||percent change||95% Confidence Interval|Least Squares Mean
800889|NCT00960934|Secondary|LS Mean Percent Change From Baseline to Month 6 in Trochanter aBMD|"DXA was used to assess and measure aBMD of the trochanter. Areal BMD was measured as areal density using units of gram (gm) of tissue /centimeter of tissue squared (cm^2)."|Baseline and Month 6|Full Analysis Set (FAS); participants who received at least one dose of study treatment, had post-randomization data subsequent to at least one dose of study treatment, and who had baseline data.||percent change||95% Confidence Interval|Least Squares Mean
800890|NCT00960934|Secondary|LS Mean Percent Change From Baseline to Month 6 in Femoral Neck aBMD|"DXA was used to assess and measure aBMD of the femoral neck. Areal BMD was measured as areal density using units of gram (gm) of tissue /centimeter of tissue squared (cm^2)."|Baseline and Month 6|Full Analysis Set (FAS); participants who received at least one dose of study treatment, had post-randomization data subsequent to at least one dose of study treatment, and who had baseline data.||percent change||95% Confidence Interval|Least Squares Mean
800891|NCT00960934|Secondary|LS Mean Percent Change From Baseline to Month 6 in Total Hip aBMD|"DXA was used to assess and measure aBMD of the total hip. Areal BMD was measured as areal density using units of gram (gm) of tissue /centimeter of tissue squared (cm^2)."|Baseline and Month 6|Full Analysis Set (FAS); participants who received at least one dose of study treatment, had post-randomization data subsequent to at least one dose of study treatment, and who had baseline data.||percent change||95% Confidence Interval|Least Squares Mean
800892|NCT00960934|Primary|Percentage of Participants With Bone Neoplasms|"Evidence of bone neoplasm(s) was considered an event of interest and was prespecified as a Tier 1 safety event."|Baseline through Month 6|All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment. 3 randomized participants did not receive treatment and were not included in the APaT.||Percentage of participants|||Number
800893|NCT00960934|Primary|Percentage of Participants With Kidney Stones|"Evidence of kidney stone(s) was considered an event of interest and was prespecified as a Tier 1 safety event."|Baseline through Month 6|All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment. 3 randomized participants did not receive treatment and were not included in the APaT.||Percentage of participants|||Number
802962|NCT00988442|Secondary|Quality of Life Measured by Euro-QoL - Usual Activities|Quality of Life Measured by Euro-QoL - Question 3: Usual activities.|Week 24|All available data from participants that reached week 24 are summarized.||Participants|||Count of Participants
800894|NCT00960934|Primary|Percentage of Participants With Albumin-Corrected Calcium Levels Outside the Pre-defined Limits of Change|"Albumin-Corrected Calcium = ([4 - plasma albumin in g/dL] × 0.8 + serum calcium).
≥10.6 mg/dL was predefined in this study as the cut-off for the normal limits of change. Participants with albumin-corrected calcium levels ≥10.6 mg/dL were considered as having a Tier 1 safety event."|Baseline through Month 6|All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment. 3 randomized participants did not receive treatment and were not included in the APaT.||Percentage of participants|||Number
800895|NCT00960934|Primary|Percentage of Participants With Total Serum Calcium Levels Outside the Pre-defined Limits of Change|"Normal serum calcium level is 8-10 mg/dL (2-2.5 mmol/L) with some interlaboratory variation in the reference range, and hypercalcemia is defined as a serum calcium level greater than 10.5 mg/dL (>2.5 mmol/L).
Based on these references, ≥10.6 mg/dL was predefined in this study as the cut-off for the normal limits of change. Participants with calcium levels ≥10.6 mg/dL were considered as having a Tier 1 safety event."|Baseline through Month 6|All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment. 3 randomized participants did not receive treatment and were not included in the APaT.||Percentage of participants|||Number
800896|NCT00960934|Primary|Least Squares (LS) Mean Percent Change From Baseline to Month 6 in Lumbar Spine Areal Bone Mineral Density (aBMD)|"Dual Energy X-ray Absorptiometry (DXA) was used to assess and measure aBMD of the lumbar spine. Areal BMD was measured as areal density using units of gram (gm) of tissue /centimeter of tissue squared (cm^2)."|Baseline (BL) and Month 6|Full Analysis Set (FAS); participants who received at least one dose of study treatment, had post-randomization data subsequent to at least one dose of study treatment, and who had baseline data.||percent change||95% Confidence Interval|Least Squares Mean
800897|NCT00960986|Secondary|Percentage of Patients Achieving Remission|Remission was defined as 17-item Hamilton Depression Rating Scale (HAMD-17) total score ≤7. HAMD-17 total scores ranged from 0 (not at all depressed)-52 (severely depressed).|Baseline up to 8 weeks|The efficacy population included the number of participants with baseline and at least 1 post-baseline value analysed under the intent-to-treat (ITT) principle according to the drug dose they were assigned.||percentage of participants|||Number
800898|NCT00960986|Secondary|Percentage of Participants Achieving Response|Response was defined as ≥50% decrease from baseline on the 17-item Hamilton Depression Rating Scale (HAMD-17) total score. HAMD-17 total scores ranged from 0 (not at all depressed)-52 (severely depressed).|Baseline up to 8 weeks|The efficacy population included the number of participants with baseline and at least 1 post-baseline value analysed under the intent-to-treat (ITT) principle according to the drug dose they were assigned.||percentage of participants|||Number
800899|NCT00960986|Secondary|Time to Resolve Nausea|Events of nausea were taken from the adverse event (AE) data. Participants were censored based on the following rules: 1=study discontinuation date if the participant discontinues the study; 2=study lost to follow-up date if the participant drops out of the study.|Nausea onset up to nausea resolve (Baseline up to 8 weeks)|The safety population included all participants who took at least 1 study drug dose analysed according to the drug dose actually taken.||days||95% Confidence Interval|Median
800900|NCT00960986|Secondary|Time to Onset of Nausea|Events of nausea were taken from the adverse event (AE) data. Participants were censored based on the following rules: 1=study discontinuation date if the participant discontinues the study; 2=study lost to follow-up date if the participant drops out of the study.|Baseline to onset of nausea (Baseline up to 8 weeks)|The safety population included all participants who took at least 1 study drug dose analysed according to the drug dose actually taken.||days||95% Confidence Interval|Median
800901|NCT00960986|Secondary|Patient Global Impression of Improvement (PGI-I) at 1 Week and 8 Weeks|The PGI-I Rating Scale was a 7-point scale: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; or 7=very much worse. Least squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction and an unstructured covariance matrix.|1 week, 8 weeks|The efficacy population included the number of participants with baseline and at least 1 post-baseline value analysed under the intent-to-treat (ITT) principle according to the drug dose they were assigned.||units on a scale||Standard Error|Least Squares Mean
800902|NCT00960986|Secondary|Mean Change From Baseline to 1-Week and 8-Week Endpoints in Clinical Global Impressions of Severity (CGI-S)|The CGI-S Rating Scale was a 7-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; or 7=extremely ill. Least squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariance matrix.|Baseline, 1 week, 8 weeks|The efficacy population included the number of participants with baseline and at least 1 post-baseline value analysed under the intent-to-treat (ITT) principle according to the drug dose they were assigned.||units on a scale||Standard Error|Least Squares Mean
800903|NCT00960986|Secondary|Mean Change From Baseline to 1-Week and 8-Week Endpoints in 17-Item Hamilton Depression Rating Scale (HAMD-17) Sleep Subscale|The HAMD-17 Sleep subscale (Items 4, 5, 6 of HAMD-17 questionnaire) evaluated initial, middle, and late insomnia. Total subscale scores ranged from 0 (no difficulty)-6 (difficulty). Least Squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariate matrix.|Baseline, 1 week, 8 weeks|The efficacy population included the number of participants with baseline and at least 1 post-baseline value analysed under the intent-to-treat (ITT) principle according to the drug dose they were assigned.||units on a scale||Standard Error|Least Squares Mean
800904|NCT00960986|Secondary|Mean Change From Baseline to 1-Week and 8-Week Endpoints in 17-Item Hamilton Depression Rating Scale (HAMD-17) Retardation/Somatization Subscale|The HAMD-17 Retardation/Somatization subscale (Items 1, 7, 8, 14 of HAMD-17 questionnaire) evaluated dysfunction in mood, work, sexual activity, and overall motor retardation. Total subscale scores ranged from 0 (normal)-14 (severe). Least Squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariate matrix.|Baseline, 1 week, 8 weeks|The efficacy population included the number of participants with baseline and at least 1 post-baseline value analysed under the intent-to-treat (ITT) principle according to the drug dose they were assigned.||units on a scale||Standard Error|Least Squares Mean
800905|NCT00960986|Secondary|Mean Change From Baseline to 1-Week and 8-Week Endpoints in 17-Item Hamilton Depression Rating Scale (HAMD-17) Anxiety/Somatization Subscale|The HAMD-17 Anxiety/Somatization subscale (Items 10, 11, 12, 13, 15, 17 of HAMD-17 questionnaire) evaluated the severity of psychic and somatic manifestations of anxiety and agitation. Total subscale scores ranged from 0 (normal)-18 (severe). Least Squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariate matrix.|Baseline, 1 week, 8 weeks|The efficacy population included the number of participants with baseline and at least 1 post-baseline value analysed under the intent-to-treat (ITT) principle according to the drug dose they were assigned.||units on a scale||Standard Error|Least Squares Mean
800906|NCT00960986|Secondary|Mean Change From Baseline to 1-Week and 8-Week Endpoints in 17-Item Hamilton Depression Rating Scale (HAMD-17) Core Mood Subscale|The HAMD-17 Core Mood subscale (Items 1, 2, 3, 7, 8 of HAMD-17 questionnaire) represented the core symptoms of depression. Total subscale scores ranged from 0 (normal)-20 (severe). Least Squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariate matrix.|Baseline, 1 week, 8 weeks|The efficacy population included the number of participants with baseline and at least 1 post-baseline value analysed under the intent-to-treat (ITT) principle according to the drug dose they were assigned.||units on a scale||Standard Error|Least Squares Mean
800907|NCT00960986|Secondary|Mean Change From Baseline to 1-Week and 8-Week Endpoints in 17-Item Hamilton Depression Rating Scale (HAMD-17) Maier Subscale|"The HAMD-17 Maier subscale (Items 1, 2, 7, 8, 9, 10 of HAMD-17 questionnaire) represented the core symptoms of depression. Total subscale scores ranged from 0 (normal)-24 (severe). Least Squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariate matrix."|Baseline, 1 week, 8 weeks|The efficacy population included the number of participants with baseline and at least 1 post-baseline value analysed under the intent-to-treat (ITT) principle according to the drug dose they were assigned.||units on a scale||Standard Error|Least Squares Mean
800908|NCT00960986|Secondary|Mean Change From Baseline to 1-Week and 8-Week Endpoints in 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score|The HAMD-17 total score ranged from 0 (not at all depressed)-52 (severely depressed). Least squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariance matrix.|Baseline, 1 week, 8 weeks|The efficacy population included the number of participants with baseline and at least 1 post-baseline value analysed under the intent-to-treat (ITT) principle according to the drug dose they were assigned.||units on a scale||Standard Error|Least Squares Mean
800909|NCT00960986|Secondary|Mean Change From Baseline to 1-Week and 8-Week Endpoints in Association for Methodology and Documentation in Psychiatry (AMDP-5) Measure: Common Adverse Events (AEs) Score|AMDP-5 common AEs score was used to create a composite measure of AEs from previous duloxetine studies (incidence >5% and 2X placebo rate). The common AEs total score was the sum of the following 8 AMDP-5 items: 1) Mean of Item 112 (nausea) + 113 (vomiting); 2) Item 111 (dry mouth); 3) Item 115 (constipation); 4) Mean of Items 101-104 (insomnia); Item 122 (increased perspiration); 8) Item 106 (decreased appetite). Score was based on a 5-point scale: 1=absent, 2=mild, 3=moderate, 4=severe, 5=extremely severe; Higher score=worse severity.|Baseline, 1 week, 8 weeks|The safety population included all participants who took at least 1 study drug dose analysed according to the drug dose actually taken.||units on a scale||Standard Error|Least Squares Mean
800910|NCT00960986|Secondary|Mean Change From Baseline to 1-Week and 8-Week Endpoints in Association for Methodology and Documentation in Psychiatry (AMDP-5) Measure: Gastric Events Score|Gastric events scores (average of Item 112 [nausea] + Item 113 [vomiting]) of AMDP-5 (Week 0-8) ranged from 0-3: 0=Not present; 1=Mild; 2=Moderate; 3=Severe. Least Squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariate matrix.|Baseline, 1 week and 8 weeks|The safety population included all participants who took at least 1 study drug dose analysed according to the drug dose actually taken.||units on a scale||Standard Error|Least Squares Mean
800911|NCT00960986|Secondary|Mean Change From Baseline to 8-Week Endpoint in Association for Methodology and Documentation in Psychiatry (AMDP-5) Adverse Event (AE) Scale Item 112 (Nausea)|Scores for AE scale Item 112 (nausea) of AMDP-5 (Week 0-8) ranged from 0-3: 0=Not present; 1=Mild; 2=Moderate; 3=Severe. Least Squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariate matrix.|Baseline, 8 weeks|The safety population included all participants who took at least 1 study drug dose analysed according to the drug dose actually taken. N = number of subjects with a baseline and post-baseline result at the Week 8 visit.||units on a scale||Standard Error|Least Squares Mean
800912|NCT00960986|Primary|Mean Maximum Nausea Severity, Association for Methodology and Documentation in Psychiatry (AMDP-5) Adverse Event (AE) Scale Item 112 (Nausea)|AMDP-5 AE scale Item 112 (nausea) measured nausea severity during treatment (Week 0-8). The scores ranged from 0-3: 0=Not present; 1=Mild; 2=Moderate; 3=Severe.|1 week and 8 weeks|The safety population included all participants who took at least 1 study drug dose analysed according to the drug dose actually taken.||units on a scale||95% Confidence Interval|Mean
800913|NCT00960999|Secondary|Association Between Biomarkers, Primary Tumor Control Rate, and ≥ Grade 2 Radiation Pneumonitis||From start of treatment to 1 year||||||
800914|NCT00960999|Secondary|Distribution of Pulmonary Function Changes by Treatment Arm and Response||From start of treatment to end of follow-up.||||||
800915|NCT00960999|Secondary|Distribution of FDG-PET (Fluorodeoxyglucose) Standardized Uptake Value Changes as a Potential Measure of Treatment Response and Outcomes||From start of treatment to date of failure (local, regional or distant), death or last follow-up.||||||
800916|NCT00960999|Secondary|1-year Overall Survival and Disease-free Survival Rate||From start of treatment to 1 year||||||
800917|NCT00960999|Secondary|1-year Primary Tumor Control Rate||From start of treatment to 1 year||||||
800984|NCT00968019|Secondary|Clinically Driven TLR|Target Lesion Revascularization (TLR) is defined as any clinically-driven repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel|Up to 30 days|309 patients treated with the Presillion stent in up to two de novo coronary artery lesions (311 lesions)||participants|Participants||Number
800918|NCT00960999|Primary|Counts of ≥ Grade 3 Adverse Events (AE) Graded by CTCAE v4 (Common Terminology Criteria for Adverse Events) That Are Definitely, Probably, or Possibly Related to Treatment (DPPRT)|Number of patients with ≥ grade 3 AE occurring within 1 year of treatment (TRT) start and reported as DPPRT among this subset of CTCAE v4: pericardial effusion, pericarditis, restrictive cardiomyopathy, dysphagia, esophagitis, esophageal fistula/obstruction/perforation/stenosis/ulcer/hemorrhage, rib fracture, brachial plexopathy, recurrent laryngeal nerve palsy, myelitis, atelectasis, bronchopulmonary/mediastinal/pleural/tracheal hemorrhage, bronchial/pulmonary/bronchopleural/tracheal fistula, hypoxia, bronchial/tracheal obstruction, pleural effusion, pneumonitis, pulmonary fibrosis, skin ulceration (thorax only), FEV1 (Forced Expiratory Volume) or FVC (forced vital capacity) decline, or grade 5 related to TRT. Each arm is considered independently. For each arm, >=5 of 38 analyzable subjects experiencing a grade ≥ 3 AE during the 1st year following TRT start would determine the respective TRT excessively toxic. For each arm this design provides 88% power with a 0.10 type I error rate.|From start of treatment to 1 year|First 38 eligible patients per arm who started treatment||participants|||Number
800919|NCT00961051|Secondary|Number of Subjects With no Corneal Staining|Corneal staining was performed via slit lamp observation of the corneal through a cobalt blue filter and a yellow #12 or #15 filter Wratten filter following contact lens removal and installation of standard sodium fluorescein.|Day 180|||participants|||Number
800920|NCT00961051|Primary|Mean Lens Cleanliness as Measured by Light Reflectance|Lens cleanliness was assessed by total light reflectance, which is a computerized quantitative assessment conducted in a laboratory. The amount of light that scattered off the lens surface in a light field and was assessed using a light reflectance score that ranged from 0 (maximum lens cleanliness; clean/clear) to100 (minimum lens cleanliness; dirty/opaque).|Day 30|Lens cleanliness analysis could only be done on subjects whose lenses were returned for analysis. Out of 270 subjects, 253 returned their study lenses to the sponsor for lab analysis (169 + 84 = 253).||light reflectance score||Standard Deviation|Mean
800921|NCT00966992|Secondary|Relationship of SUVmax and Metabolic Heterogeneity in the Primary Tumor and Evidence of Persistent/Recurrent Disease||3 months after completion of treatment and 9 months after completion of treatment|This outcome measure could not be analyzed as there were no participants enrolled in the zometa arm and the outcome measure required comparing results from the no zometa arm to the zometa arm.|||||
800922|NCT00966992|Secondary|If Depressed and Anxious Moods Are Associated With Greater Impairment of Adaptive Immunity and Higher Levels of Angiogenesis in Peripheral Blood||At diagnosis, 6 months after completion of treatment, and 9 months after completion of treatment|This outcome measure could not be analyzed as there were no participants enrolled in the zometa arm and the outcome measure required comparing results from the no zometa arm to the zometa arm.|||||
800923|NCT00966992|Secondary|Change in Biochemical Markers of Bone Turnover||At the time of diagnosis and 9 months after completion of treatment|This outcome measure could not be analyzed as there were no participants enrolled in the zometa arm and the outcome measure required comparing results from the no zometa arm to the zometa arm.|||||
800924|NCT00966992|Secondary|Change in Bone Mineral Density||At the time of diagnosis and 9 months after completion of treatment|This outcome measure could not be analyzed as there were no participants enrolled in the zometa arm and the outcome measure required comparing results from the no zometa arm to the zometa arm.|||||
800925|NCT00966992|Primary|Incidence of Disseminated Tumor Cells in Bone Marrow||At time of diagnosis, 3 months after completion of treatment, and 9 months after completion of treatment|This outcome measure could not be analyzed as there were no participants enrolled in the zometa arm and the outcome measure required comparing results from the no zometa arm to the zometa arm.|||||
800926|NCT00966992|Primary|Incidence of Circulating Tumor Cells (CTCs)||At time of diagnosis, 3 months after completion of treatment, and 9 months after completion of treatment|This outcome measure could not be analyzed as there were no participants enrolled in the zometa arm and the outcome measure required comparing results from the no zometa arm to the zometa arm.|||||
800927|NCT00967005|Primary|Hamilton Anxiety Rating Scale Total Score|Week 24 represents the 3-month follow-up period (ie, corresponds to being off N-acetylcysteine or placebo and done with imaginal desensitization and motivational interviewing for 12 weeks). This scale measures anxiety symptoms, tension, somatic symptoms, difficulty concentrating, and others. Total score is computed by summing the scores on the 14 items (each item is scored from 0 to 4). Minimum score= 0 and maximum score= 56, with higher scores signifying more severe anxiety symptoms.|Week 24|||units on a scale||Standard Deviation|Mean
800928|NCT00967005|Primary|Hamilton Anxiety Rating Scale Total Score|Week 12 corresponds to end of 6 sessions of N-acetylcysteine plus imaginal desensitization and motivational interviewing versus placebo plus imaginal desensitization and motivational interviewing. This scale measures anxiety symptoms, tension, somatic symptoms, difficulty concentrating, and others. Total score is computed by summing the scores on the 14 items (each item is scored from 0 to 4). Minimum score= 0 and maximum score= 56, with higher scores signifying more severe anxiety symptoms.|Week 12|||units on a scale||Standard Deviation|Mean
800929|NCT00967005|Primary|Hamilton Anxiety Rating Scale Total Score|Week 6 corresponds to end of N-acetylcysteine plus Ask-Advise-Refer therapy versus placebo plus Ask-Advise-Refer therapy. This scale measures anxiety symptoms, tension, somatic symptoms, difficulty concentrating, and others. Total score is computed by summing the scores on the 14 items (each item is scored from 0 to 4). Minimum score= 0 and maximum score= 56, with higher scores signifying more severe anxiety symptoms.|Week 6|||units on a scale||Standard Deviation|Mean
800930|NCT00967005|Primary|Hamilton Anxiety Rating Scale Total Score|Week 0 corresponds to baseline. This scale measures anxiety symptoms, tension, somatic symptoms, difficulty concentrating, and others. Total score is computed by summing the scores on the 14 items (each item is scored from 0 to 4). Minimum score= 0 and maximum score= 56, with higher scores signifying more severe anxiety symptoms.|Week 0|||units on a scale||Standard Deviation|Mean
800931|NCT00967005|Primary|Hamilton Depression Rating Scale Total Score|Week 24 represents the 3-month follow-up period (ie, corresponds to being off N-acetylcysteine or placebo and done with imaginal desensitization and motivational interviewing for 12 weeks). This scale assesses depressed mood, feelings of guilt, difficulty sleeping, somatic symptoms, and others. Total score is computed by summing the scores of the 17 items. Minimum score is 0 and maximum score is 52, with higher scores signifying more severe depressive symptoms.|Week 24|||units on a scale||Standard Deviation|Mean
800932|NCT00967005|Primary|Hamilton Depression Rating Scale Total Score|Week 12 corresponds to end of 6 sessions of N-acetylcysteine plus imaginal desensitization and motivational interviewing versus placebo plus imaginal desensitization and motivational interviewing. This scale assesses depressed mood, feelings of guilt, difficulty sleeping, somatic symptoms, and others. Total score is computed by summing the scores of the 17 items. Minimum score is 0 and maximum score is 52, with higher scores signifying more severe depressive symptoms.|Week 12|||units on a scale||Standard Deviation|Mean
800933|NCT00967005|Primary|Hamilton Depression Rating Scale Total Score|Week 6 corresponds to end of N-acetylcysteine plus Ask-Advise-Refer therapy versus placebo plus Ask-Advise-Refer therapy. This scale assesses depressed mood, feelings of guilt, difficulty sleeping, somatic symptoms, and others. Total score is computed by summing the scores of the 17 items. Minimum score is 0 and maximum score is 52, with higher scores signifying more severe depressive symptoms.|Week 6|||units on a scale||Standard Deviation|Mean
800934|NCT00967005|Primary|Hamilton Depression Rating Scale Total Score|Week 0 corresponds to baseline. This scale assesses depressed mood, feelings of guilt, difficulty sleeping, somatic symptoms, and others. Total score is computed by summing the scores of the 17 items. Minimum score is 0 and maximum score is 52, with higher scores signifying more severe depressive symptoms.|Week 0|||units on a scale||Standard Deviation|Mean
800935|NCT00967005|Primary|Fagerstrom Test for Nicotine Dependence Total Score|Week 24 represents the 3-month follow-up period (ie, corresponds to being off N-acetylcysteine or placebo and done with imaginal desensitization and motivational interviewing for 12 weeks). This scale has 6 questions. Questions 1 and 4 are on a scale from 0 to 3 (higher scores being more severe symptoms) and questions 2, 3, 5, and 6 are on a scale from 0 to 1 (1 being more severe symptoms). Scores on all questions are summed to compute total score, with higher total score meaning more severe nicotine dependence. Scores range from 0 to 10.|Week 24|||units on a scale||Standard Deviation|Mean
800936|NCT00967005|Primary|Fagerstrom Test for Nicotine Dependence Total Score|Week 12 corresponds to end of 6 sessions of N-acetylcysteine plus imaginal desensitization and motivational interviewing versus placebo plus imaginal desensitization and motivational interviewing. This scale has 6 questions. Questions 1 and 4 are on a scale from 0 to 3 (higher scores being more severe symptoms) and questions 2, 3, 5, and 6 are on a scale from 0 to 1 (1 being more severe symptoms). Scores on all questions are summed to compute total score, with higher total score meaning more severe nicotine dependence. Scores range from 0 to 10.|Week 12|||units on a scale||Standard Deviation|Mean
800937|NCT00967005|Primary|Fagerstrom Test for Nicotine Dependence Total Score|Week 6 corresponds to end of N-acetylcysteine plus Ask-Advise-Refer therapy versus placebo plus Ask-Advise-Refer therapy. This scale has 6 questions. Questions 1 and 4 are on a scale from 0 to 3 (higher scores being more severe symptoms) and questions 2, 3, 5, and 6 are on a scale from 0 to 1 (1 being more severe symptoms). Scores on all questions are summed to compute total score, with higher total score meaning more severe nicotine dependence. Scores range from 0 to 10.|Week 6|||units on a scale||Standard Deviation|Mean
800938|NCT00967005|Primary|Fagerstrom Test for Nicotine Dependence Total Score|Week 0 corresponds to baseline. This scale has 6 questions. Questions 1 and 4 are on a scale from 0 to 3 (higher scores being more severe symptoms) and questions 2, 3, 5, and 6 are on a scale from 0 to 1 (1 being more severe symptoms). Scores on all questions are summed to compute total score, with higher total score meaning more severe nicotine dependence. Scores range from 0 to 10.|Week 0|||units on a scale||Standard Deviation|Mean
800939|NCT00967005|Primary|Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Behavior Subscale|Week 24 represents the 3-month follow-up period (ie, corresponds to being off N-acetylcysteine or placebo and done with imaginal desensitization and motivational interviewing for 12 weeks). Questions 6 through 10 are summed to compute the thoughts/urges subscale. Minimum=0 and maximum=20, with higher scores signifying more severe gambling behaviors.|Week 24|||units on a scale||Standard Deviation|Mean
800940|NCT00967005|Primary|Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Behavior Subscale|Week 12 corresponds to end of 6 sessions of N-acetylcysteine plus imaginal desensitization and motivational interviewing versus placebo plus imaginal desensitization and motivational interviewing. Questions 6 through 10 are summed to compute the thoughts/urges subscale. Minimum=0 and maximum=20, with higher scores signifying more severe gambling behaviors.|Week 12|||units on a scale||Standard Deviation|Mean
800941|NCT00967005|Primary|Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Behavior Subscale|Week 6 corresponds to end of N-acetylcysteine plus Ask-Advise-Refer therapy versus placebo plus Ask-Advise-Refer therapy. . Questions 6 through 10 are summed to compute the thoughts/urges subscale. Minimum=0 and maximum=20, with higher scores signifying more severe gambling behaviors.|Week 6|||units on a scale||Standard Deviation|Mean
800942|NCT00967005|Primary|Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Behavior Subscale|Week 0 corresponds to baseline. Questions 6 through 10 are summed to compute the thoughts/urges subscale. Minimum=0 and maximum=20, with higher scores signifying more severe gambling behaviors.|Week 0|||units on a scale||Standard Deviation|Mean
800943|NCT00967005|Primary|Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Urges/Thoughts Subscale|Week 24 represents the 3-month follow-up period (ie, corresponds to being off N-acetylcysteine or placebo and done with imaginal desensitization and motivational interviewing for 12 weeks). Questions 1 through 5 are summed to compute the thoughts/urges subscale. Minimum=0 and maximum=20, with higher scores signifying more severe thoughts/urges.|Week 24|||units on a scale||Standard Deviation|Mean
800944|NCT00967005|Primary|Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Urges/Thoughts Subscale|Week 12 corresponds to end of 6 sessions of N-acetylcysteine plus imaginal desensitization and motivational interviewing versus placebo plus imaginal desensitization and motivational interviewing. Questions 1 through 5 are summed to compute the thoughts/urges subscale. Minimum=0 and maximum=20, with higher scores signifying more severe thoughts/urges.|Week 12|||units on a scale||Standard Deviation|Mean
800945|NCT00967005|Primary|Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Urges/Thoughts Subscale|Week 6 corresponds to end of N-acetylcysteine plus Ask-Advise-Refer therapy versus placebo plus Ask-Advise-Refer therapy. Questions 1 through 5 are summed to compute the thoughts/urges subscale. Minimum=0 and maximum=20, with higher scores signifying more severe thoughts/urges.|Week 6|||units on a scale||Standard Deviation|Mean
802963|NCT00988442|Secondary|Quality of Life Measured by Euro-QoL - Self-Care|Quality of Life Measured by Euro-QoL - Question 2: Self-Care.|Week 24|All available data from participants that reached week 24 are summarized.||Participants|||Count of Participants
800947|NCT00967005|Primary|Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Total Score|Week 24 represents the 3-month follow-up period (ie, corresponds to being off N-acetylcysteine or placebo and done with imaginal desensitization and motivational interviewing for 12 weeks). Minimum score=0 and maximum score=40, with higher score signifying more severe symptoms. Scale is 10 items scored from 0 to 4. Scores on each item are summed to compute total score. Thoughts/urges (questions 1 to 5) and behavior (questions 6 to 10) are added to get the total score.|Week 24|||units on a scale||Standard Deviation|Mean
800948|NCT00967005|Primary|Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Total Score|Week 12 corresponds to end of 6 sessions of N-acetylcysteine plus imaginal desensitization and motivational interviewing versus placebo plus imaginal desensitization and motivational interviewing. Minimum score=0 and maximum score=40, with higher score signifying more severe symptoms. Scale is 10 items scored from 0 to 4. Scores on each item are summed to compute total score. Thoughts/urges (questions 1 to 5) and behavior (questions 6 to 10) are added to get the total score.|Week 12|||units on a scale||Standard Deviation|Mean
800949|NCT00967005|Primary|Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Total Score|Week 6 corresponds to end of N-acetylcysteine plus Ask-Advise-Refer therapy versus placebo plus Ask-Advise-Refer therapy. Minimum score=0 and maximum score=40, with higher score signifying more severe symptoms. Scale is 10 items scored from 0 to 4. Scores on each item are summed to compute total score. Thoughts/urges (questions 1 to 5) and behavior (questions 6 to 10) are added to get the total score.|Week 6|||units on a scale||Standard Deviation|Mean
800950|NCT00967005|Primary|Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Total Score|Week 0 corresponds to baseline. Minimum score=0 and maximum score=40, with higher score signifying more severe symptoms. Scale is 10 items scored from 0 to 4. Scores on each item are summed to compute total score. Thoughts/urges (questions 1 to 5) and behavior (questions 6 to 10) are added to get the total score.|Week 0|||units on a scale||Standard Deviation|Mean
800951|NCT00967018|Other Pre-specified|Serum Levels of Testosterone Over Time|Testosterone levels were measured over time. The table below shows median levels at baseline (n=77 participants), 24 weeks (n=68), 36 weeks (n=59), 48 weeks (n=54), 72 weeks (n=9)|from baseline to week 72|The table below shows median levels at baseline (n=77 participants), 24 weeks (n=68), 36 weeks (n=59), 48 weeks (n=54), 72 weeks (n=9)||ng/mL||Full Range|Median
800952|NCT00967018|Other Pre-specified|Serum Levels of Prostate Specific Antigen (PSA)Over Time|PSA levels were measured over time. The table below shows median levels at baseline (n=77 participants), 24 weeks (n=56), 36 weeks (n=58), 48 weeks (n=48), 72 weeks (n=9)|from baseline to 72 weeks|The table below shows median levels at baseline (n=77 participants), 24 weeks (n=56), 36 weeks (n=58), 48 weeks (n=48), 72 weeks (n=9)||ng/mL||Full Range|Median
800953|NCT00967018|Primary|Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight|This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value.|Up to 22.5 months|||Participants|||Number
800954|NCT00967018|Primary|Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables|The figures present the number of participants who had markedly abnormal levels of safety laboratory variables. Only the laboratory variables that had at least one percentage of participants in either group with abnormal value are presented, more variables were included in the study.|Up to 22.5 months|||Participants|||Number
800955|NCT00967044|Primary|Maximum Tolerated Dose (MTD) of Everolimus With Panobinostat|MTD of the novel combination of Everolimus + Panobinostat (LBH589) in a phase-I study in participants with relapsed lymphoma (Hodgkin and non-Hodgkin) where MTD is defined as the highest dose at which no more than 1 in 6 of the participants in the cohort experiences one or more dose limiting toxicities (DLTs) in the first 28 day treatment cycle. Thirty patients were enrolled onto four dose levels: Everolimus (mg, orally) 5, 5, 10, 10 daily or Panobinostat (mg, orally) 10, 20, 20, 30 three times per week. The MTD was established without the use of colony stimulating factor in cycle 1.|28 day treatment cycle|||mg, orally|||Number
800956|NCT00967226|Secondary|Constitutional Adverse Events|Number of constitutional AEs in each study arm.|enrollment to study close out or withdrawal up to 9 months|||Adverse Events|||Number
800957|NCT00967226|Secondary|Vascular Adverse Events|Number of Vascular AEs in each study arm.|enrollment to study withdrawal or close out up to 9 months|||Adverse Events|||Number
800958|NCT00967226|Secondary|Metabolic or Laboratory AEs|Number of Metabolic or Laboratory AEs in each study arm.|enrollment to study withdrawal or close out up to 9 months|||Adverse Events|||Number
800959|NCT00967226|Secondary|Infectious Adverse Events|Number of infectious AEs in each study arm (i.e. conjunctivitis, thrush, fever)|enrollment to study withdrawal or close out up to 9 months|||Adverse Events|||Number
800960|NCT00967226|Secondary|Gastrointestinal Adverse Events|Number of Gastrointestinal AEs in each arm|enrollment to study withdrawal or study close out up to 9 months|||Adverse Events|||Number
800961|NCT00967226|Secondary|Endocrinologic Adverse Events|Number of Endocrinologic AEs (of which adrenal crisis does not overlap).|enrollment to close out or study withdrawal up to 9 months|||Adverse Events|||Number
800962|NCT00967226|Secondary|Dermatologic Adverse Events|Number of Dermatologic Adverse Events in each study arm.|enrollment to study close out or withdrawal up to 9 months|||Adverse Events|||Number
800963|NCT00967226|Secondary|Allergy/Immunology Adverse Events|Number of allergy/immunology AE per study arm|enrollment through study closeout or study withdrawal up to 9 months|||Adverse Events|||Number
800964|NCT00967226|Secondary|Pulmonary/Respiratory Adverse Events|Number of pulmonary/respiratory adverse events (CTCAE 22) in each study arm|enrollment through study close out or withdrawal, up to 9 months|||Adverse Events|||Number
800965|NCT00967226|Secondary|Growth and Development Adverse Events|Number of Growth and Development AEs in each study arm|enrollment to study withdrawal or close out up to 9 months|||Adverse Events|||Number
800985|NCT00968019|Secondary|Procedural Success|Procedural success defined as achievement of a final diameter stenosis of <50% (by visual estimate) using any percutaneous method, without the occurrence of death, MI (Myocardial Infarction), or repeat revascularization of the target lesion during the hospital stay|Peri-procedure up to discharge|318 patients treated with the Presillion stent in up to two de novo coronary artery lesions (354 lesions)||percentage of Procedural Success|Participants||Number
800966|NCT00967226|Secondary|Number of Serious Adverse Events (SAEs)|Number of serious adverse events experienced by the participants in each treatment arm within the categories adrenal crisis, growth/development, constitutional. Serious adverse events are defined as events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, result in a persistent or significant disability/incapacity, or result in a congenital anomaly/birth defect. Other important medical events, based upon appropriate medical judgment, may also be considered Serious Adverse Events if a trial participant's health is at risk and intervention is required to prevent an outcome mentioned.|enrollment until study close out or withdrawal up to 9 months|||Serious Adverse Events|||Number
800967|NCT00967226|Secondary|Tolerability of Medication|All adverse events relating to medication tolerability including: adrenal crisis, growth/development, constitutional (dehydration), allergy/immunology, dermatologic, endocrine, GI, infection, metabolism/labs, pulmonary, vascular.|enrollment until study close out or withdrawal up to 9 months|"All adverse events relating to medication tolerability including: adrenal crisis, growth/development, constitutional (dehydration), allergy/immunology, dermatologic, endocrine, GI, infection, metabolism/labs, pulmonary, vascular. In this table Adverse Events are those exclusive of the Serious Adverse Events which are noted separately."||Events|||Number
800968|NCT00967226|Primary|Decrease in Size of Hemangioma (Length x Width) in Square mm|A priori primary outcome was proportional change in the total surface area as measured by lesion's outer margin length x width at baseline minus the same measure at 4 months with surrogate data used at 5 months if 4 months not available.|4-5 months after initiating therapy|Data available at 4 or 5 months for only 9/11 propranolol participants and for 6/8 prednisolone participants due to missed appointments. Overall, 90% (138/154) study appointments were completed.||mm squared||95% Confidence Interval|Mean
800969|NCT00967993|Secondary|The Incidence of Treatment-emergent Adverse Events (New or Worsened From Study Drug Initiation) Will be Summarized by Body System, Severity, Type of Adverse Event, and Presumed Relationship to the Study Drug.||6 weeks||||||
800970|NCT00967993|Primary|The Primary Outcome of This Trial Will be the Change in Serum Phosphorus From Baseline to End of Treatment After a Four Week Treatment Period.||4 weeks|||mg/dL||Standard Deviation|Mean
800971|NCT00968019|Secondary|Stroke||Up to 12 months|||participants|||Number
800972|NCT00968019|Secondary|Stent Thrombosis|Thrombosis is defined as the formation of blood clot derived from aggregation of red cells or platelets obstructing the lumen of the vessel.|Up to 12 months|||participants|||Number
800973|NCT00968019|Secondary|Major Bleeding||Up to 12 months|||participants|||Number
800974|NCT00968019|Secondary|Myocardial Infarction|"A positive diagnosis of myocardial infarction is made when one of the following criteria is met:
Typical rise and/or fall of biochemical markers of myocardial necrosis together with evidence of ischemia with at least one of the following:
ischemic symptoms
ECG changes indicative of ischemia (ST segment elevation or depression)
Development of pathological Q waves in the ECG
Imaging evidence of new an equivocal loss of viable myocardium or new regional wall motion abnormality
Pathological findings of an acute myocardial infarction"|Up to 12 months|303 patients treated with the Presillion stent in up to two de novo coronary artery lesions (308 lesions)||participants|Participants||Number
800975|NCT00968019|Secondary|Target Vessel Failure|"Target vessel failure includes any target vessel revascularization as well as any MI or any cardiac death that cannot be clearly attributed to a non-target vessel.
Target vessel failure will be reported when:
MI occurs in territory not clearly attributed to a vessel other than the target vessel.
Cardiac death not clearly due to a non-target vessel endpoint.
Target vessel revascularization is performed."|Up to 12 months|303 patients treated with the Presillion stent in up to two de novo coronary artery lesions (308 lesions)||participants|Participants||Number
800976|NCT00968019|Secondary|Clinically Driven TVR|Target vessel revascularization (TVR) is defined as any clinically driven (as defined for TLR) repeat percutaneous intervention of the target vessel or bypass surgery of the target vessel.|Up to 12 months|303 patients treated with the Presillion stent in up to two de novo coronary artery lesions (308 lesions)||participants|Participants||Number
800977|NCT00968019|Secondary|Clinically Driven TLR|Target Lesion Revascularization (TLR) is defined as any clinically-driven repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel|up to 12 months|303 patients treated with the Presillion stent in up to two de novo coronary artery lesions (308 lesions)||participants|Participants||Number
800978|NCT00968019|Secondary|Stent Thrombosis|Thrombosis is defined as the formation of blood clot derived from aggregation of red cells or platelets obstructing the lumen of the vessel.|Up to 30 days|||participants|||Number
800979|NCT00968019|Secondary|Stroke||Up to 30 days|||participants|||Number
800980|NCT00968019|Secondary|Major Bleeding||Up to 30 days|||participants|||Number
800981|NCT00968019|Secondary|Myocardial Infarction|"A positive diagnosis of myocardial infarction is made when one of the following criteria is met:
Typical rise and/or fall of biochemical markers of myocardial necrosis together with evidence of ischemia with at least one of the following:
ischemic symptoms
ECG changes indicative of ischemia (ST segment elevation or depression)
Development of pathological Q waves in the ECG
Imaging evidence of new an equivocal loss of viable myocardium or new regional wall motion abnormality
Pathological findings of an acute myocardial infarction"|Up to 30 days|309 patients treated with the Presillion stent in up to two de novo coronary artery lesions (311 lesions)||participants|Participants||Number
800982|NCT00968019|Secondary|Target Vessel Failure|"Target vessel failure includes any target vessel revascularization as well as any MI or any cardiac death that cannot be clearly attributed to a non-target vessel.
Target vessel failure will be reported when:
MI occurs in territory not clearly attributed to a vessel other than the target vessel.
Cardiac death not clearly due to a non-target vessel endpoint.
Target vessel revascularization is performed."|Up to 30 days|309 patients treated with the Presillion stent in up to two de novo coronary artery lesions (311 lesions)||participants|Participants||Number
800983|NCT00968019|Secondary|Clinically Driven TVR|Target vessel revascularization (TVR) is defined as any clinically driven (as defined for TLR) repeat percutaneous intervention of the target vessel or bypass surgery of the target vessel.|Up to 30 days|309 patients treated with the Presillion stent in up to two de novo coronary artery lesions (311 lesions)||participants|Participants||Number
802964|NCT00988442|Secondary|Quality of Life Measured by Euro-QoL - Mobility|Quality of life measured by Euro-QoL - Question 1: Mobility.|Week 24|Available data for participants that reached week 24 are summarized.||Participants|||Count of Participants
800987|NCT00968019|Secondary|Device Success|Device success defined as achievement of a final diameter stenosis of <50% (by visual estimate), using the assigned device only|Peri-procedure up to discharge|318 patients treated with the Presillion stent in up to two de novo coronary artery lesions (354 lesions)||percentage of device success|Participants||Number
800988|NCT00968019|Primary|Major Cardiac Adverse Events (Including Cardiac Death, Myocardial Infarction (Q-wave and Non Q-wave) and Clinically Driven TLR (Target Lesion Revascularization))|"Major adverse cardiac and cerebral events are defined as an adjudicated composite of cardiac death, myocardial infarction (Q-wave and non Q-wave), emergent coronary artery bypass surgery and target vessel revascularization (TVR).
The primary safety measure was the composite of MACE up to 12 months follow up. In order to show the safety of the device, the MACE rate was compared with the performance goal for bare metal stents(experience with bare metal stents in clinical trials suggested that the 12 month MACE rate should be about 25.0%)."|at 12 months follow-up|No formal statistical significance testing was performed. Descriptive statistics were calculated for all relevant variables (mean, standard deviation, median and ranges for the continuous variables and with frequencies and % for the discrete variables). Subjects who discontinued prematurely were included in the analysis and were not replaced.||participants|||Number
800989|NCT00968032|Primary|Number of Participants With a Successful Implantation.|The implantation of the device under investigation in a single patient is defined as successful if delivery, placement and release of the device in a stable position is successful. The value will be compared to the number of patient enrolled.|6 weeks ± 2 weeks|||participants|||Number
800990|NCT00968071|Primary|Number of Participants With Complete Response (CR)|Complete Response (CR) was defined as normalization of peripheral blood and bone marrow with </= 5% blasts, a peripheral anc >/= 1 * 10^9 /l, and a platelet count of >/= 100 & 10^9 /l. Evaluation after each treatment course (5-6 weeks) up to 6 cycles.|Up to 36 weeks|||participants|||Number
800991|NCT00968149|Secondary|Number of Patients Who Were Discontinued Due to LAEs||2 weeks|All patients who took study medication during the 2-week, double-blind treatment period and had at least one laboratory test post baseline were included in the analysis.||Participants|||Number
800992|NCT00968149|Secondary|Number of Patients With Drug-related LAEs||2 weeks|All patients who took study medication during the 2-week, double-blind treatment period and had at least one laboratory test post baseline were included in the analysis.||Participants|||Number
800993|NCT00968149|Secondary|Number of Patients With Serious LAEs|Serious LAEs are any LAEs occurring at any dose that: Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose|2 weeks|All patients who took study medication during the 2-week, double-blind treatment period and had at least one laboratory test post baseline were included in the analysis.||Participants|||Number
800994|NCT00968149|Secondary|Number of Patients With Laboratory Adverse Experiences (LAEs)|A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|2 weeks|All patients who took study medication during the 2-week, double-blind treatment period and had at least one laboratory test post baseline were included in the analysis.||Participants|||Number
800995|NCT00968149|Secondary|Number of Patients Who Were Discontinued Due to CAEs||2 weeks|All patients who took study medication during the 2-week, double-blind treatment period were included in the analysis.||Participants|||Number
800996|NCT00968149|Secondary|Number of Patients With Drug-related CAEs|Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs|2 weeks|All patients who took study medication during the 2-week, double-blind treatment period were included in the analysis.||Participants|||Number
800997|NCT00968149|Secondary|Number of Patients With Serious CAEs|Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose|2 weeks|All patients who took study medication during the 2-week, double-blind treatment period were included in the analysis.||Participants|||Number
800998|NCT00968149|Primary|Number of Patients With Clinical Adverse Experiences (CAEs)|A clinical adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|2 weeks|All patients who took study medication during the 2-week, double-blind treatment period were included in the analysis.||Participants|||Number
800999|NCT00968201|Secondary|Number of Patients Who Were Discontinued Due to Serious Drug-related LAEs - Extension|Patients who were discontinued due to serious drug-related LAEs with up to 2.8 years of treatment|up to 2.8 years|All patients who took study medication and had at least one laboratory test post baseline were included in the analysis.||Participants|||Number
801000|NCT00968201|Secondary|Number of Patients Who Were Discontinued Due to Serious LAEs - Extension|Patients who were discontinued due to serious LAEs with up to 2.8 years of treatment|up to 2.8 years|All patients who took study medication and had at least one laboratory test post baseline were included in the analysis.||Participants|||Number
801001|NCT00968201|Secondary|Number of Patients Who Were Discontinued Due to Drug-related LAEs - Extension|Patients who were discontinued due to drug-related LAEs with up to 2.8 years of treatment|up to 2.8 years|All patients who took study medication and had at least one laboratory test post baseline were included in the analysis.||Participants|||Number
801002|NCT00968201|Secondary|Number of Patients Who Were Discontinued Due to LAEs - Extension|Patients who were discontinued due to LAEs up to 2.8 years of treatment|up to 2.8 years|All patients who took study medication and had at least one laboratory test post baseline were included in the analysis.||Participants|||Number
801003|NCT00968201|Secondary|Number of Patients With Serious Drug-related Laboratory Adverse Experiences (LAEs) - Extension|Patients who reported serious drug-related LAEs up to 2.8 years of treatment|up to 2.8 years|All patients who took study medication and had at least one laboratory test post baseline were included in the analysis.||Participants|||Number
801152|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin|Subject response to question: did you feel that your skin was hydrated and moisturized while you on your study product? (Yes or No).|Week 1, Week 2|ITT||Participants|||Number
801004|NCT00968201|Secondary|Number of Patients With Serious LAEs - Extension|Serious LAEs are any LAEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose|up to 2.8 years|All patients who took study medication and had any laboratory tests performed were included in the analysis.||Participants|||Number
801005|NCT00968201|Secondary|Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) - Extension|Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs|up to 2.8 years|All patients who took study medication and had at least one laboratory test post baseline were included in the analysis.||Participants|||Number
801006|NCT00968201|Secondary|Number of Patients With Laboratory Adverse Experiences (LAEs) - Extension|A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|up to 2.8 years|All patients who took study medication were included in the analysis.||Participants|||Number
801007|NCT00968201|Secondary|Number of Patients Who Were Discontinued Due to Serious Drug-related CAEs - Extension|Patients who were discontinued due to serious drug-related CAEs with up to 2.8 years of treatment|up to 2.8 years|All patients who took study medication were included in the analysis.||Participants|||Number
801008|NCT00968201|Secondary|Number of Patients Who Were Discontinued Due to Serious CAEs - Extension|Patients who were discontinued due to serious CAEs with up to 2.8 years of treatment|up to 2.8 years|All patients who took study medication were included in the analysis.||Participants|||Number
801009|NCT00968201|Secondary|Number of Patients Who Were Discontinued Due to Drug-related CAEs - Extension|Patients who were discontinued due to drug-related CAEs with up to 2.8 years of treatment|up to 2.8 years|All patients who took study medication were included in the analysis.||Participants|||Number
801010|NCT00968201|Secondary|Number of Patients Who Were Discontinued Due to CAEs - Extension|Patients who were discontinued due to CAEs up to 2.8 years of treatment|up to 2.8 years|All patients who took study medication were included in the analysis.||Participants|||Number
801011|NCT00968201|Secondary|Number of Patients With Serious Drug-related CAEs Reported by Patients - Extension|"Patients who reported serious drug-related CAEs up to 2.8 years of
treatment"|up to 2.8 years|All patients who took study medication were included in the analysis.||Participants|||Number
801012|NCT00968201|Secondary|Number of Patients With Serious CAEs Reported by Patients - Extension|Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose|up to 2.8 years|All patients who took study medication were included in the analysis.||Participants|||Number
801013|NCT00968201|Secondary|Number of Patients With Drug-related CAEs Reported by Patients - Extension|Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs|up to 2.8 years|All patients who took study medication were included in the analysis.||Participants|||Number
801014|NCT00968201|Secondary|Number of Patients With Clinical Adverse Experiences (CAE) Reported by Patients - Extension|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|up to 2.8 years|All patients who took study medication were included in the analysis.||Participants|||Number
801015|NCT00968201|Secondary|Number of Patients Who Were Discontinued Due to Drug-related LAEs - Base Study|Patients who were discontinued due to drug-related LAEs during 12 weeks of treatment|12 weeks of treatment|All patients who took study medication and had at least one laboratory test post baseline were included in the analysis.||Participants|||Number
801016|NCT00968201|Secondary|Number of Patients Who Were Discontinued Due to LAEs - Base Study|Patients who were discontinued due to LAEs during 12 weeks of treatment|12 weeks of treatment|All patients who took study medication and had at least one laboratory test post baseline were included in the analysis.||Participants|||Number
801017|NCT00968201|Secondary|Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) - Base Study|Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs|12 weeks of treatment|All patients who took study medication and had at least one laboratory test post baseline were included in the analysis.||Participants|||Number
801018|NCT00968201|Secondary|Number of Patients With Laboratory Adverse Experiences (LAEs) - Base Study|A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|12 weeks of treatment|All patients who took study medication and had at least one laboratory test post baseline were included in the analysis.||Participants|||Number
801019|NCT00968201|Secondary|Number of Patients Who Were Discontinued Due to Serious CAEs - Base Study|Patients who were discontinued due to serious CAEs during 12 weeks of treatment|12 weeks of treatment|All patients who took study medication were included in the analysis.||Participants|||Number
801020|NCT00968201|Secondary|Number of Patients Who Were Discontinued Due to Drug-related CAEs - Base Study|Patients who were discontinued due to drug-related CAEs during 12 weeks of treatment|12 weeks of treatment|All patients who took study medication were included in the analysis.||Participants|||Number
801021|NCT00968201|Secondary|Number of Patients Who Were Discontinued Due to CAEs - Base Study|Patients who were discontinued due to CAEs during 12 weeks of treatment|12 weeks of treatment|All patients who took study medication were included in the analysis.||Participants|||Number
801022|NCT00968201|Secondary|Number of Patients With Serious Drug-related CAEs Reported by Patients - Base Study|Patients who reported serious drug-related CAEs during 12 weeks of treatment|12 weeks of treatment|All patients who took study medication were included in the analysis.||Participants|||Number
801153|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Compliance|Subject response to question regarding use of the product every day or not at week 8 time point answering Yes or No|Week 8|ITT||Participants|||Number
807036|NCT01018511|Secondary|CL/F of Solifenacin||Week 4, Week 8 and Week 12|"PKAS population. N indicates the number of participants with available data at each timepoint."||L/h||Geometric Coefficient of Variation|Geometric Mean
801023|NCT00968201|Secondary|Number of Patients With Serious CAEs Reported by Patients - Base Study|Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose|12 weeks of treatment|"All patients who took study medication were included in the analysis.
A serious CAE (study drug overdose) prior to randomization in the Placebo group is not included in this number"||Participants|||Number
801024|NCT00968201|Secondary|Number of Patients With Drug-related CAEs Reported by Patients - Base Study|Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs|12 weeks of treatment|"All patients who took study medication were included in the analysis.
Drug relationship for 1 patient in the Placebo group should have been listed as definitely not drug related."||Participants|||Number
801025|NCT00968201|Primary|Number of Patients With Clinical Adverse Experiences (CAE) Reported by Patients - Base Study|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|12 weeks of treatment|All patients who took study medication were included in the analysis.||Participants|||Number
801026|NCT00968227|Secondary|Change in Oxygen Extraction Fraction in Regions With Low Baseline Delivery.|Change in oxygen extraction fraction after transfusion of 1 unit of RBC in regions with low baseline delivery (DO2 < 4.5 ml/100g/min.|1 hour|||fraction||Standard Deviation|Mean
801027|NCT00968227|Primary|Change in Oxygen Delivery in Vulnerable Brain Regions|Change in oxygen delivery after transfusion in brain regions with low baseline delivery.|1 hour|||ml/100g/min||Standard Deviation|Mean
801028|NCT00968617|Secondary|Number of Participants Who Were Responders|Responder was defined as a participant achieving (pre-transfusion) an increase from baseline hemoglobin of greater than or equal to 1 g/dL and a hemoglobin concentration of greater than or equal to 11 g/dL.|Each week up to 12 weeks|||Participants|||Number
801029|NCT00968617|Secondary|Change From Baseline in Hemoglobin Level||Weeks 1-3, 5-10, and Week 12|||g/dL||Standard Deviation|Mean
801030|NCT00968617|Secondary|Hemoglobin Concentration After Treatment With MK2578||Weeks 1-10 and Week 12|||g/dL||Standard Deviation|Mean
801031|NCT00968617|Primary|Number of Participants With Confirmed, Treatment Emergent Antibodies to MK2578||16 Weeks|||Participants|||Number
801032|NCT00968617|Primary|Number of Participants With Hypertension, Seizure, and Pure Red Cell Aplasia||16 Weeks|||Participants|||Number
801033|NCT00968617|Primary|Number of of Participants With Composite Events of Injection Site Reactions||16 Weeks|||Participants|||Number
801034|NCT00968617|Primary|Number of Participants With Composite Events of Transfusion-related Adverse Experiences||16 Weeks|||Participants|||Number
801035|NCT00968617|Primary|Number of Participants With Composite Events of Death, Myocardial Infarction and Cerebrovascular Accident, Serious Events of Unstable Angina, Transient Ischemic Attack, Arrythmia and Congestive Heart Failure, Peripheral Thrombo-embolic Events||16 Weeks|||Participants|||Number
801036|NCT00968617|Primary|Change From Baseline in Hemoglobin Level at Week 4||4 weeks|||g/dL||Standard Deviation|Mean
801037|NCT00968669|Secondary|Accumulation Ratio of Trough Concentrations of MEDI-528|Accumulation ratio of trough concentrations of MEDI-528 in subjects receiving 30, 100, or 300 mg MEDI-528. Serum concentrations of MEDI-528 were measured on Days 1, 15, 29, 57, 85, 127, 169, 176, 204, 232, 260, 288, and 323.|Days 1, 15, 29, 57, 85, 127, 169, 176, 204, 232, 260, 288, and 323|All participants who were randomized into the 30 mg MEDI-528 (n=81), 100 mg MEDI-528 (n=83), 300 mg MEDI-528 (n=81) and received at least one dose of investigational product.||Ratio||Standard Deviation|Mean
801038|NCT00968669|Secondary|Half Life of MEDI-528|Half life of MEDI-528 in subjects receiving 30, 100, or 300 mg MEDI-528. Serum concentrations of MEDI-528 were measured on Days 1, 15, 29, 57, 85, 127, 169, 176, 204, 232, 260, 288, and 323.|Days 1, 15, 29, 57, 85, 127, 169, 176, 204, 232, 260, 288, and 323|All participants randomized into the 30, 100, or 300 mg MEDI-528 group (n=81, 83, or 81, respectively).||Days||Standard Deviation|Mean
801039|NCT00968669|Secondary|Day 169 Steady State Trough Concentration of MEDI-528|Trough concentration of MEDI-528 measured on Day 169 prior to administration of the last dose of MEDI-528 (30, 100, or 300 mg). Serum concentrations of MEDI-528 were measured on Days 1, 15, 29, 57, 85, 127, 169, 176, 204, 232, 260, 288, and 323. Steady state trough concentration of MEDI-528 was measured on Day 169.|Day 169|All participants randomized into the 30, 100, or 300 mg MEDI-528 group (n=81, 83, or 81, respectively).||Microgram per milliliter||Standard Deviation|Mean
801040|NCT00968669|Secondary|First Dose Trough Concentration of MEDI-528|First dose trough concentration of MEDI-528 measured on Day 15 prior to administration of the second dose of MEDI-528 (30, 100, or 300 mg). Serum concentrations of MEDI-528 were measured on Days 1, 15, 29, 57, 85, 127, 169, 176, 204, 232, 260, 288, and 323. The first dose trough concentration of MEDI-528 was measured on Day 15 prior to the Day 15 dose.|Day 15|All participants randomized into the 30, 100, or 300 mg MEDI-528 group (n=81, 83, or 81, respectively).||Microgram per milliliter||Standard Deviation|Mean
801041|NCT00968669|Secondary|Proportion of Participants With Detectable Anti-drug Antibodies to MEDI-528|Proportion of participants with detectable anti-drug antibodies to MEDI-528 in subjects receiving 30, 100, or 300 mg MEDI-528 and placebo|Days 1, 29, 57, 85, 127, 169, 176, 204,260, and 323|All participants who were randomized into the 30 mg MEDI-528 (n=81), 100 mg MEDI-528 (n=83), 300 mg MEDI-528 (n=81), or placebo (n=82) group and received at least one dose of investigational product.||Participants|||Number
801067|NCT00968812|Secondary|Percentage of Patients Experiencing at Least 1 Hypoglycemic Event From Baseline to Week 52|The table below shows the percentage of patients who experienced at least 1 documented hypoglycemic event from Baseline to Week 52 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in percentages.|Day 1 (Baseline) and Week 52|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 52 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percentage of patients|||Number
803612|NCT00993499|Secondary|Best Overall Response|Best overall response (unconfirmed) according to RECIST v1.1|From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days|Treated set||Percentage of participants|||Number
801042|NCT00968669|Secondary|Proportion of Participants Who Had a Asthma Quality of Life Questionnaire - Standard (AQLQ[S]) Assessment Response at Day 176 (Intent-to-Treat Analysis)|Effect of MEDI-528 (30, 100, or 300 mg) versus placebo on the proportion of participants who had an AQLQ(S) assessment response at Day 176 (Intent-to-Treat Analysis). The AQLQ(S) is a 32-item questionnaire that measures the health related quality of life experienced by asthma patients. In the study, participants were asked to recall their experiences during the previous 2 weeks and to score each of the 32 questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score is calculated as the mean response to all questions. Individual improvement in the overall score of 0.5 has been identified as the minimally important difference, with score changes > 1.5 identified to be large meaningful differences.|Day 176|All participants who were randomized into the 30 mg MEDI-528 (n=81), 100 mg MEDI-528 (n=83), 300 mg MEDI-528 (n=81), or placebo group (n=82) who had AQLQ(S) data at Day 176 (n=62, 58, 64, and 60 for placebo, 30, 100, and 300 mg MEDI-528, respectively).||Participants|||Number
801043|NCT00968669|Secondary|Proportion of Participants Who Had a Asthma Quality of Life Questionnaire - Standard (AQLQ[S]) Assessment Response at Day 85 (Intent-to-Treat Analysis)|Effect of MEDI-528 (30, 100, or 300 mg) versus placebo on the proportion of participants who had an AQLQ(S) assessment response (defined as an improvement of at least 0.5 score in AQLQ[S]) at Day 85 (Intent-to-Treat Analysis). The AQLQ(S) is a 32-item questionnaire that measures the health related quality of life experienced by asthma patients. In the study, participants were asked to recall their experiences during the previous 2 weeks and to score each of the 32 questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score is calculated as the mean response to all questions. Individual improvement in the overall score of 0.5 has been identified as the minimally important difference, with score changes > 1.5 identified to be large meaningful differences.|Day 85|All participants who were randomized into the 30 mg MEDI-528 (n=81), 100 mg MEDI-528 (n=83), 300 mg MEDI-528 (n=81), or placebo group (n=82) who had AQLQ(S) data at Day 85 (n=69, 63, 76, and 68 for placebo, 30, 100, and 300 mg MEDI-528, respectively).||Participants|||Number
801044|NCT00968669|Secondary|Change at Day 176 From Baseline in Forced Expiratory Volume in One Second (FEV1) (Intent-to-Treat Analysis)|Effect of MEDI-528 (30, 100, or 300 mg) versus placebo on the mean change from baseline (Day 1, prior to dosing) in FEV1 at Day 176|Day 176|All participants randomized into the 30, 100, or 300 mg MEDI-528 (n=81, 83, or 81, respectively) or placebo (n=82) groups who had FEV1 data available at Day 176 (n=67, 75, or 73 for 30, 100, or 300 mg MEDI-528, respectively, and n=69 for placebo).||Liters||Standard Deviation|Mean
801045|NCT00968669|Secondary|Change at Day 92 From Baseline in Forced Expiratory Volume in One Second (FEV1) (Intent-to-Treat Analysis)|Effect of MEDI-528 (30, 100, or 300 mg) versus placebo on the mean change at Day 92 from baseline (Day 1, prior to dosing) in FEV1.|Day 92|All participants randomized into the 30, 100, or 300 mg MEDI-528 (n=81, 83, or 81, respectively) or placebo (n=82) groups who had FEV1 data available at Day 92 (n=62, 73, or 72 for 30, 100, or 300 mg MEDI-528, respectively, and n=67 for placebo).||Liters||Standard Deviation|Mean
801046|NCT00968669|Secondary|Time to First Observed Mean Asthma Control Questionnaire (ACQ) Change From Baseline > or = 0.5 Through Day 176 (Intent-to-Treat Analysis)|Effect of MEDI-528 (30, 100, or 300 mg) versus placebo on the time to first observed mean ACQ change from baseline (Day 1, prior to dosing) > or = 1.5 Through Day 176 (Intent-to-Treat Analysis). The 6-item ACQ is a participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and daily rescue bronchodilator use. Participants were asked to recall how their asthma had been during the previous week. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score is the mean of the responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score ≥ 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful.|Days 1 - 176|All participants who were randomized into the 30 mg MEDI-528 (n=81), 100 mg MEDI-528 (n=83), 300 mg MEDI-528 (n=81), or placebo group (n=82) who had ACQ data through Day 176.||Day||95% Confidence Interval|Median
801047|NCT00968669|Secondary|Time to First Observed Mean Asthma Control Questionnaire (ACQ) Change From Baseline > or = 0.5 Through Day 92 (Intent-to-Treat Analysis)|Effect of MEDI-528 (30, 100, or 300 mg) versus placebo on the time to first observed mean ACQ change from baseline (Day 1, prior to dosing) > or = 0.5 through Day 92 (Intent-to-Treat Analysis). The 6-item ACQ is a participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and daily rescue bronchodilator use. Participants were asked to recall how their asthma had been during the previous week. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score is the mean of the responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score ≥ 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful.|Days 1 - 92|All participants who were randomized into the 30 mg MEDI-528 (n=81), 100 mg MEDI-528 (n=83), 300 mg MEDI-528 (n=81), or placebo group (n=82) who had ACQ data through Day 92.||Day||95% Confidence Interval|Median
801048|NCT00968669|Secondary|Proportion of Participants Achieving Mean Asthma Control Questionnaire (ACQ) Scores at Day 176 of < or = 0.75, > 0.75 to < 1.5, and > or = 1.5 (Intent-to-Treat Analysis)|Proportion of participants achieving mean ACQ scores of < or = 0.75, > 0.75 to < 1.5, and > or = 1.5 at Day 176 in participants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). The 6-item ACQ is a participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and daily rescue bronchodilator use. Participants were asked to recall how their asthma had been during the previous week. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score is the mean of the responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score ≥ 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful.|Day 176|All participants who were randomized into the 30 mg MEDI-528 (n=81), 100 mg MEDI-528 (n=83), 300 mg MEDI-528 (n=81), or placebo group (n=82) who had ACQ data available on Day 176.||Participants|||Number
801424|NCT00972543|Secondary|Haematology Laboratory Assessments - Haematocrit|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits|||participants|||Number
801049|NCT00968669|Secondary|Proportion of Participants Achieving Mean Asthma Control Questionnaire (ACQ) Scores at Day 92 of < or = 0.75, > 0.75 to < 1.5, and > or = 1.5 (Intent-to-Treat Analysis)|Proportion of participants achieving mean ACQ scores of < or = 0.75, > 0.75 to < 1.5, and > or = 1.5 at Day 92 in participants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). The 6-item ACQ is a participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and daily rescue bronchodilator use. Participants were asked to recall how their asthma had been during the previous week. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score is the mean of the responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score ≥ 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful.|Day 92|All participants who were randomized into the 30 mg MEDI-528 (n=81), 100 mg MEDI-528 (n=83), 300 mg MEDI-528 (n=81), or placebo group (n=82) who had ACQ data available on Day 92.||Participants|||Number
801050|NCT00968669|Secondary|Change at Day 176 From Baseline in Mean Asthma Control Questionnaire Scores (Intent-to-Treat Analysis)|Change at Day 176 from baseline (Day 1, prior to dosing) in mean ACQ scores in participants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). The 6-item ACQ is a participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and daily rescue bronchodilator use. Participants were asked to recall how their asthma had been during the previous week. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score is the mean of the responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score ≥ 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful.|Day 176|All participants who were randomized into the 30 mg MEDI-528 (n=81), 100 mg MEDI-528 (n=83), 300 mg MEDI-528 (n=81), or placebo group (n=82) who had ACQ data available on Day 176.||Scores on a scale||Standard Deviation|Mean
801051|NCT00968669|Secondary|Time to First Asthma Exacerbation Through Day 176 (Intent-to-Treat Analysis)|Time to first asthma exacerbation between Day 1 and Day 176 in pariticpants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). An exacerbation was defined as a progressive increase of asthma symptoms AND a reduction of 20% or more in peak expiratory flow (PEF) or forced expiratory volume in 1 second (FEV1) from baseline (Day 1, prior to dosing) or best previously measured value prior to the current event that did not resolve after the initiation of rescue medications; and results in a prescription for/or administration of systemic corticosteroid burst therapy by the investigator or health care provider. An exacerbation event was considered resolved when the subject’s asthma symptoms diminished and PEF or FEV1 return to greater than 80% of baseline for 7 or more days after completion of systemic corticosteroid burst therapy.|Days 1 - 176|All participants who were randomized and received at least one dose of investigational product (30, 100, or 300 mg MEDI-528 or placebo)||Day||95% Confidence Interval|Median
801052|NCT00968669|Secondary|Time to First Asthma Exacerbation Through Day 92 (Intent-to-Treat Analysis)|Time to first asthma exacerbation between Day 1 and Day 92 in pariticpants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). An exacerbation was defined as a progressive increase of asthma symptoms AND a reduction of 20% or more in peak expiratory flow (PEF) or forced expiratory volume in 1 second (FEV1) from baseline (Day 1, prior to dosing) or best previously measured value prior to the current event that did not resolve after the initiation of rescue medications; and results in a prescription for/or administration of systemic corticosteroid burst therapy by the investigator or health care provider. An exacerbation event was considered resolved when the subject’s asthma symptoms diminished and PEF or FEV1 return to greater than 80% of baseline for 7 or more days after completion of systemic corticosteroid burst therapy.|Days 1 - 92|All participants who were randomized and received at least one dose of investigational product (30, 100, or 300 mg MEDI-528 or placebo)||Day||95% Confidence Interval|Median
801053|NCT00968669|Secondary|Proportion of Participants Experiencing at Least One Asthma Exacerbation Through Day 176 (Intent-to-Treat Analysis)|The proportion of participants that experienced at least one asthma exacerbation between Day 1 and Day 176 in pariticpants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). An exacerbation was defined as a progressive increase of asthma symptoms AND a reduction of 20% or more in peak expiratory flow (PEF) or forced expiratory volume in 1 second (FEV1) from baseline (Day 1, prior to dosing) or best previously measured value prior to the current event that did not resolve after the initiation of rescue medications; and results in a prescription for/or administration of systemic corticosteroid burst therapy by the investigator or health care provider. An exacerbation event was considered resolved when the subject’s asthma symptoms diminished and PEF or FEV1 return to greater than 80% of baseline for 7 or more days after completion of systemic corticosteroid burst therapy.|Days 1 - 176|All participants who were randomized and received at least one dose of investigational product (30, 100, or 300 mg MEDI-528 or placebo)||Participants|||Number
801054|NCT00968669|Secondary|Proportion of Participants Experiencing at Least One Asthma Exacerbation Through Day 92 (Intent-to-Treat Analysis)|The proportion of participants that experienced at least one asthma exacerbation between Day 1 and Day 92 in pariticpants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). An exacerbation was defined as a progressive increase of asthma symptoms AND a reduction of 20% or more in peak expiratory flow (PEF) or forced expiratory volume in 1 second (FEV1) from baseline (Day 1, prior to dosing) or best previously measured value prior to the current event that did not resolve after the initiation of rescue medications; and results in a prescription for/or administration of systemic corticosteroid burst therapy by the investigator or health care provider. An exacerbation event was considered resolved when the subject’s asthma symptoms diminished and PEF or FEV1 return to greater than 80% of baseline for 7 or more days after completion of systemic corticosteroid burst therapy.|Days 1 - 92|All participants who were randomized and received at least one dose of investigational product (30, 100, or 300 mg MEDI-528 or placebo)||Participants|||Number
801122|NCT00969540|Secondary|Sleep Variables (Sleep Efficiency) Measured With Actigraphy in Patients With Lower Back Pain.|Secondary outcome: Sleep efficiency in placebo mattress cover compared to active mattress cover.|Assessed daily for 14 days per intervention.|The sponsor determined the number of participants.||Percentage of time asleep||Standard Deviation|Mean
822938|NCT01165983|Secondary|Absolute Change in Inflammatory Cytokines and Growth Factors, G-CSF, pg/mL||12 Weeks post-randomization|||pg/mL||Inter-Quartile Range|Median
801055|NCT00968669|Secondary|Weighted Asthma Exacerbation Rate Through Day 176 (Intent-to-Treat Analysis)|Weighted asthma exacerbation rate (total number of exacerbation rate in each group per total duration of participant-year follow-up in each group) between Day 1 and Day 176 in pariticpants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). An exacerbation was defined as a progressive increase of asthma symptoms AND a reduction of 20% or more in peak expiratory flow (PEF) or forced expiratory volume in 1 second (FEV1) from baseline (Day 1, prior to dosing) or best previously measured value prior to the current event that did not resolve after the initiation of rescue medications; and results in a prescription for/or administration of systemic corticosteroid burst therapy by the investigator or health care provider. An exacerbation event was considered resolved when the subject’s asthma symptoms diminished and PEF or FEV1 return to greater than 80% of baseline for 7 or more days after completion of systemic corticosteroid burst therapy.|Days 1 - 176|All participants who were randomized and received at least one dose of investigational product (30, 100, or 300 mg MEDI-528 or placebo)||Exacerbations per participant year||95% Confidence Interval|Number
801056|NCT00968669|Secondary|Weighted Asthma Exacerbation Rate Through Day 92 (Intent-to-Treat Analysis)|Weighted asthma exacerbation rate (total number of exacerbation rate in each group per total duration of participant-year follow-up in each group) between Day 1 and Day 92 in pariticpants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). An exacerbation was defined as a progressive increase of asthma symptoms AND a reduction of 20% or more in peak expiratory flow (PEF) or forced expiratory volume in 1 second (FEV1) from baseline (Day 1, prior to dosing) or best previously measured value prior to the current event that did not resolve after the initiation of rescue medications; and results in a prescription for/or administration of systemic corticosteroid burst therapy by the investigator or health care provider. An exacerbation event was considered resolved when the subject’s asthma symptoms diminished and PEF or FEV1 return to greater than 80% of baseline for 7 or more days after completion of systemic corticosteroid burst therapy.|Days 1 - 92|All participants who were randomized and received at least one dose of investigational product (30, 100, or 300 mg MEDI-528 or placebo)||Exacerbations per participant year||95% Confidence Interval|Number
801057|NCT00968669|Primary|Change at Day 92 From Baseline in Mean Asthma Control Questionnaire (ACQ) Scores (Intent-toTreat Analysis)|Change at Day 92 from baseline (Day 1, prior to dosing) in mean ACQ scores in pariticpants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). The 6-item ACQ is a participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and daily rescue bronchodilator use. Participants were asked to recall how their asthma had been during the previous week. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score is the mean of the responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score ≥ 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful.|Day 92|All participants randomized into the 30, 100, or 300 mg MEDI-528 (n=81, 83, or 81, respectively) or placebo (n=82) groups.||Scores on a scale||Standard Deviation|Mean
801058|NCT00968708|Secondary|Percentage of Participants With Secondary Major Adverse Cardiac Events (MACE)|Secondary MACE composite consisted of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or urgent revascularization due to unstable angina; these events were adjudicated by an independent cardiovascular endpoint committee.|From randomization until the adjudication cut-of date of May 31 2013 (maximum time on study was 41 months).|Full analysis set||percentage of participants|||Number
801059|NCT00968708|Primary|Percentage of Participants With Primary Major Adverse Cardiac Events (MACE)|Primary Major Adverse Cardiac Events were defined as a composite of cardiovascular death, nonfatal myocardial infarction and nonfatal stroke; these events were adjudicated by an independent cardiovascular endpoints committee.|From randomization until the adjudication cut-off date of May 31 2013 (maximum time on study was 41 months).|Full analysis set (all randomized participants)||percentage of participants|||Number
801060|NCT00968799|Secondary|Pharmacokinetics|data not analysed due to poor accrual|intraoperative and 1 week after surgery||||||
801061|NCT00968799|Secondary|Overall Survival||5 years|||months||Full Range|Median
801062|NCT00968799|Secondary|Surgical Complications|any serious surgical event (Dindo scale >= III (reoperation required) or CTCAE grade >=3)|6 weeks post operation|||participants|||Number
801063|NCT00968799|Secondary|Nephrotoxicity|glomerular filtration rate (GFR)|6 weeks post operation|||participants|||Number
801064|NCT00968799|Primary|Fitness for Systemic Chemotherapy|"Are patients fit to receive six courses of systemic carboplatin chemotherapy after completion of trial.
If chemotherapy starts within 3 months after surgery and at least 4 courses could be administered, patient is considered fit.
If chemotherapy is stopped early for reasons clearly unrelated to study treatment (e.g. platinum resistance), patient is also considered fit."|3 months post operation|||participants|||Number
801065|NCT00968812|Secondary|Change in HbA1c From Baseline to Week 104|The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 104 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in the LS mean change.|Baseline, Week 104|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug).||Percent||Standard Error|Least Squares Mean
801066|NCT00968812|Secondary|Percent Change in Body Weight From Baseline to Week 52|The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 52 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in the LS mean percent change.|Day 1 (Baseline) and Week 52|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 52 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percent change||Standard Error|Least Squares Mean
801123|NCT00969540|Secondary|Sleep Variables (Nocturnal Awakenings) Measured With Actigraphy in Patients With Lower Back Pain.|Secondary outcome: Number of nocturnal awakenings with placebo mattress cover compared to active mattress cover.|Assessed daily for 14 days per intervention.|The sponsor determined the number of participants.||Awakenings||Standard Deviation|Mean
803613|NCT00993499|Primary|Occurrence of Dose Limiting Toxicities (DLT)|Number of participants with of dose limiting toxicities (DLT)|2 first cycles, 56 days|Treated set||Participants|||Number
801068|NCT00968812|Primary|Change in HbA1c From Baseline to Week 52|The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 52 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in the LS mean change.|Day 1 (Baseline) and Week 52|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 52 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percent||Standard Error|Least Squares Mean
801069|NCT00968838|Primary|Number of Participants Alive at Day 30|Participant survival measured over the 30 days subsequent to the first granulocyte transfusion. Collecting complete blood counts (CBCs) pre and post transfusion allows determination of whether the duration of neutrophil replacement differs between the two study groups (comparing unradiated white blood cells to radiated white blood cell infusion).|30 Days|||Participants|||Number
801070|NCT00968890|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Day 0 to Day 364|The analysis was performed on the Total Vaccinated cohort.||subjects|||Number
801071|NCT00968890|Secondary|Number of Subjects With Adverse Events of Specific Interest|Adverse events of specific interest include autoimmune diseases and other immune mediated inflammatory disorders.|From Day 0 to Day 364|The analysis was performed on the Total Vaccinated cohort.||subjects|||Number
801072|NCT00968890|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms|From Day 0 to Day 83|The analysis was performed on the Total Vaccinated cohort.||subjects|||Number
801073|NCT00968890|Secondary|Number of Subjects With Solicited Local and General Symptoms|Solicited local symptoms are pain, redness and swelling at the injection site. They are divided between solicited local symptoms occurring after administration of Pandemrix, Fluarix or Placebo. Solicited general symptoms are fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and temperature (defined as axillary temperature >= 38.0 degrees Celsius).|Within 7 days (Day 0-Day 6) after each vaccination|Analysis was performed on the Total Vaccinated cohort.||subjects|||Number
801074|NCT00968890|Secondary|Number of Subjects With Titers Equal to or Above Titer 1:10|"The cut-off 1:10 was considered as seropositivity.
The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08."|Days 0, 21, 42, 182, 364|The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom blood samples were taken and immunogenicity data were available.||subjects|||Number
801075|NCT00968890|Primary|Geometric Mean Fold Rise (GMFR) After the Second Dose of Pandemrix and After Vaccination With Fluarix|"The GMFR is defined as the Geometric Mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.
The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08."|21 days after the second dose of Pandemrix (=Day 42) and after vaccination with Fluarix (=Day 21 for Pandemrix+Fluarix and Pandemrix+Placebo Group or Day 42 for Pandemrix+ Placebo and Pandemrix+Fluarix Group)|The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom blood samples were taken and immunogenicity data were available.||ratio||95% Confidence Interval|Geometric Mean
801076|NCT00968890|Primary|Number of Seroprotected Subjects After the Second Dose of Pandemrix and After Vaccination With Fluarix|"A seroprotected subject was a subject with reciprocal HI titers >= 40 against the vaccine homologous virus.
The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08."|21 days after the second dose of Pandemrix (=Day 42) and after vaccination with Fluarix (=Day 21 for Pandemrix+Fluarix and Pandemrix+Placebo Group or Day 42 for Pandemrix+ Placebo and Pandemrix+Fluarix Group)|The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom blood samples were taken and immunogenicity data were available.||subjects|||Number
801077|NCT00968890|Secondary|Geometric Mean Fold Rise (GMFR)|The GMFR is defined as the Geometric Mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.|at Day 21 (for Pandemrix vaccine strain only), Day 182 and Day 364|The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom blood samples were taken and immunogenicity data were available.||ratio||95% Confidence Interval|Geometric Mean
801078|NCT00968890|Secondary|Number of Seroprotected Subjects|A seroprotected subject is a subject with reciprocal HI titers >= 40 against the vaccine homologous virus. The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.|at Day 21 (for Pandemrix vaccine strain only), Day 182 and Day 364|The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom blood samples were taken and immunogenicity data were available.||subjects|||Number
801079|NCT00968890|Secondary|Number of Seroconverted Subjects|"A seroconverted subject is a subject who had either a pre-vaccination reciprocal hemagglutination inhibition (HI) titer < 10 and a postvaccination reciprocal titer >= 40, or a pre-vaccination reciprocal HI titer >= 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.
The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08."|at Day 21 (for Pandemrix vaccine strain only), Day 182 and Day 364|The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom blood samples were taken and immunogenicity data were available.||subjects|||Number
801080|NCT00968890|Secondary|Geometric Mean Titers for Antibodies Against Pandemrix and Fluarix Vaccine Strains|"Titers are expressed as GMTs.
The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08."|Days 0, 21, 42, 182, 364|The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom blood samples were taken and immunogenicity data were available.||titer||95% Confidence Interval|Geometric Mean
803614|NCT00993616|Primary|Duration of Progression-free Interval for All Patients||Up to 5 years||||||
801081|NCT00968890|Primary|Number of Seroconverted Subjects After the Second Dose of Pandemrix and After Vaccination With Fluarix|"A seroconverted subject is a subject who had either a pre-vaccination reciprocal hemagglutination inhibition (HI) titer < 10 and a postvaccination reciprocal titer >= 40, or a pre-vaccination reciprocal HI titer >= 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.
The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08."|21 days after the second dose of Pandemrix (=Day 42) and after vaccination with Fluarix (=Day 21 for Pandemrix+Fluarix and Pandemrix+Placebo Group or Day 42 for Pandemrix+ Placebo and Pandemrix+Fluarix Group)|The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom blood samples were taken and immunogenicity data were available.||subjects|||Number
801082|NCT00968981|Primary|Time to Achieve Maximum Observed Plasma Concentration (Tmax) After a Single Dose of GDC-0449||0, 1, 2, 4, 6, 24, 48, 72 hours on Day 1|PK Evaluable Population.||hours||Full Range|Median
801083|NCT00968981|Secondary|Duration of Response (DR)|DR during first line therapy is defined as the time from when response (complete response [CR] or partial response [PR]) was first documented to first documented disease progression or death (whichever occurs first) during first line therapy. This was only be calculated for participants who achieved a best overall response of CR or PR. Participants who did not progress or die after they had a confirmed response were censored at the date of their last tumor measurement or last follow up for progression of disease during first line therapy. CR: disappearance of all target lesions (TLs) with any pathological lymph nodes (whether target or non-target) having a reduction in short axis to less than 10 millimeters. PR: at least a 30% decrease in the sum of diameters of TLs, with reference to baseline sum diameters. DR was not calculated as only 1 responding participant reached their response at the last scheduled response assessment, hence follow-up data are not available.|Screening Day 57, and every 8 weeks thereafter up to 52 weeks||||||
801084|NCT00968981|Primary|Area Under the Curve From Time Zero to the Last Measured Concentration (AUClast) for Total and Unbound GDC-0449|AUC values were calculated using the linear trapezoidal method when the concentrations were rising and using the logarithmic trapezoidal method when the concentrations were declining (linear up/log down rule in WinNonlin). BLQ values at pre-dose were considered as zero for PK analysis.|Predose and 1, 2, 4, 6, 24, 48, and 72 on Days 1, 29, 50, and 54 and predose on Days 8, 10, 15, 22, 33, 36, 43, and 57|PK Evaluable Population. n = number of participants with data available at specified time point in each group.||mcM*hour||Standard Deviation|Mean
801085|NCT00968981|Primary|Area Under the Curve From Time Zero to 24 Hour (AUC0-24) for Total and Unbound GDC-0449|AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. AUC values were calculated using the linear trapezoidal method when the concentrations were rising and using the logarithmic trapezoidal method when the concentrations were declining (linear up/log down rule in WinNonlin). Below the limit of quantitation (BLQ) values at pre-dose were considered as zero for PK analysis.|Predose and 1, 2, 4, 6, 24, 48, and 72 on Days 1, 29, 50, and 54 and predose on Days 8, 10, 15, 22, 33, 36, 43, and 57|PK Evaluable Population. n = number of participants with data available at specified timepoint in each group.||mcM*hour||Standard Deviation|Mean
801086|NCT00968981|Primary|Maximum Plasma Concentration (Cmax) of Total and Unbound GDC−0449|Plasma GDC-0449 concentrations were reported in ng/mL units and converted to mcM units using the molecular weight (421.30 g/mol) prior to PK analysis.|0, 1, 2, 4, 6, 24, 48, 72 hours on Day 1, 15 and 57 post-dose|PK Evaluable Population. 'n' signifies number of participants with data available at specified timepoint in each group.||mcM||Standard Deviation|Mean
801087|NCT00968981|Primary|Plasma Concentration at Steady State (Css) for Total and Unbound GDC−0449|Plasma GDC-0449 concentrations were reported in nanogram per milliliter (ng/mL) units and converted to micromolar (mcM) units using the molecular weight (421.30 grams per mole [g/mol]) prior to PK analysis. Css was calculated for Days 28 to 56.|Predose and 1, 2, 4, 6, 24, 48, and 72 on Days 1, 29, 50, and 54 and predose on Days 8, 10, 15, 22, 33, 36, 43, and 57|PK Evaluable Population. N = participants with baseline and post baseline data available for measurement of Css at steady state.||mcM||Standard Deviation|Mean
801088|NCT00968981|Primary|Ratio of Total and Unbound Trough GDC-0449 Concentration Between Day 57 to Day 15|Ratio = trough concentration on Day 57 divided by trough concentration on Day 15. If the ratio of total and unbound trough GDC-0449 concentration between Day 57 to Day 15 is less than 1, then it indicates reduction in total and unbound trough GDC-0449 concentration between Day 15 to Day 57.|Predose and 1, 2, 4, 6, 24, 48, and 72 on Days 1, 29, 50, and 54 and predose on Days 8, 10, 15, 22, 33, 36, 43, and 57|The PK Evaluable Population. N = participants who completed Day 57 of the study were included in this analysis.||ratio||Full Range|Mean
801089|NCT00968981|Primary|Number of Participants With Greater Than (>) 50 Percent (%) Decrease in Trough Concentration at Steady State (Css, Trough)|Percent change = ([trough concentration on Day 15 minus trough concentration on Day 57] divided by trough concentration on Day 15) multiplied by 100.|Predose and 1, 2, 4, 6, 24, 48, and 72 on Days 1, 29, 50, and 54 and predose on Days 8, 10, 15, 22, 33, 36, 43, and 57|PK Evaluable Population. Here number of participants analyzed (N) = participants with baseline and at least 1 post baseline assessment for this outcome.||participants|||Number
801090|NCT00968981|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) at Steady-State for Both Total and Unbound GDC-0449||Predose and 1, 2, 4, 6, 24, 48, and 72 on Days 1, 29, 50, and 54 and predose on Days 8, 10, 15, 22, 33, 36, 43, and 57|The PK Evaluable Population. Number of participants analyzed (N) is equal to (=) participants with baseline and at least one post-baseline assessment for this outcome; n = participants evaluable at specified time-points.||hours||Full Range|Median
801091|NCT00968981|Secondary|Progression-Free Survival (PFS) Time|PFS defined as the time from study treatment initiation to the first occurrence of disease progression, as determined by the investigator review of tumor assessments using RECIST, or death from any cause during the study (i.e., within 30 days after the last dose of study treatment).|Screening Day 57, and every 8 weeks thereafter up to 52 weeks|Efficacy Evaluable Population.||months||95% Confidence Interval|Median
801124|NCT00969540|Secondary|Sleep Variables (Total Sleep) Measured With Actigraphy in Patients With Lower Back Pain.|Secondary outcome: Total sleep time with placebo mattress cover compared to active mattress cover.|Assessed daily for 14 days per intervention.|The sponsor determined the number of participants.||Minutes||Standard Deviation|Mean
803615|NCT00993616|Primary|Survival Time for All Patients||Up to 5 years||||||
803616|NCT00993616|Primary|Frequency and Severity of Observed Adverse Effects Graded According to NCI CTCAE Version 4.0||Up to 5 years||||||
801092|NCT00968981|Secondary|Percentage of Participants With a Response by Best Overall Response (BOR)|BOR was defined as the best overall response observed during the treatment period according to RECIST. CR: disappearance of all TLs, with any pathological lymph nodes (whether target or non-target) having a reduction in short axis to less than 10 mm. PR: at least a 30% decrease in the sum of diameters of TLs, taking as reference the BL sum diameters. Progressive disease (PD): at least a 20% increase in the sum of diameters of TLs, taking as a reference the smallest sum on study (this included the baseline sum if that is the smallest on study). In addition to the relative increase in 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. Stable disease (SD) was defined as neither sufficient shrinkages to qualify for PR, nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|Screening Day 57, and every 8 weeks thereafter up to 52 weeks|Efficacy Evaluable Population; only participants with measurable disease at baseline were included in the analysis.||percentage of participants|||Number
801093|NCT00968981|Secondary|Percentage of Participants With Disease Progression or Death|Disease progression (assessed by Response Evaluation Criteria in Solid Tumors [RECIST]) was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions or the appearance of one or more new lesions and/or unequivocal progression of existing non target lesions.|Screening, Day 57, and every 8 weeks thereafter up to 52 weeks|Efficacy Evaluable Population: all participants who had measurable disease at baseline and either had at least one follow-up tumor assessment or discontinued the study due to disease progression.||percentage of participants|||Number
801094|NCT00969124|Secondary|Time Spent During Withdrawal Phase and Total Procedure|Time in minutes for withdrawal phase of procedure and for total procedure|During the colonoscopy procedure (up to 1 hour, average 25 minutes)|||minutes||Standard Deviation|Mean
801095|NCT00969124|Primary|Detection Rates for All Polyps|All polyps detected with the colonoscope alone vs. with the Retroscope|During the colonoscopy procedure (up to 1 hour, average 25 minutes)|||All polyps|||Number
801096|NCT00969124|Primary|Detection Rates for Adenomas|Adenomas detected with the colonoscope alone vs. with the Retroscope|During the colonoscopy procedure (up to 1 hour, average 25 minutes)|||Adenomas|||Number
801097|NCT00969150|Secondary|Change in Sheehan Disability Scale (SDS) Total Score|The Sheehan Disability Scale (SDS) is a 3-item clinician-rated questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. All items are rated on an 11-point continuum (0 = no impairment to 10 = most severe) with the total SDS score ranging from 0 (no impairment) to 30 (most severe)|From Baseline to Week 8|||units on a scale||Standard Error|Least Squares Mean
801098|NCT00969150|Primary|Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|"MADRS was used to assess depressive symptomatology during the past week. Patients are rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest.
Each item of the 10 items are scored on a 7-point scale. A score of 0 indicates the absence of symptoms,and a score of 6 indicates symptoms of maximum severity. The total MADRS score for this measure ranges from 0 (absence of symptoms) to 60 (maximum severity)."|From Baseline to Week 8|Of the 357 patients who received at least 1 dose of double-blind treatment (Safety Population), 355 patients had at least 1 postbaseline MADRS assessment (Intent to Treat [ITT] Population).||units on a scale||Standard Error|Least Squares Mean
801099|NCT00969228|Secondary|Number of Subjects Reporting Rotavirus Gastroenteritis Episode(s)||From Dose 1 up to 1 month after Dose 2.|Analysis was performed on the Total Vaccinated Cohort.||subjects|||Number
801100|NCT00969228|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Throughout the study period (2-3 months).|Analysis was performed on the Total Vaccinated Cohort.||subjects|||Number
801101|NCT00969228|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31-day (Day 0 – Day 30) follow-up period after each vaccine dose|Analysis was performed on the Total Vaccinated Cohort.||subjects|||Number
801102|NCT00969228|Secondary|Number of Subjects Reporting Solicited Symptoms|Solicited symptoms assessed include cough, diarrhoea, irritability, loss of appetite , fever and vomiting.|During the 8-day (Day 0 – Day 7) follow-up period after each vaccine dose.|Analysis was performed on the Total Vaccinated Cohort.||subjects|||Number
801103|NCT00969228|Secondary|Serum Anti-rotavirus Immunoglobulin A Antibody Concentrations|Concentrations are given as Geometric Mean Concentrations (GMCs). Note: In the Placebo Group the value was below the assay cut-off (20 units per milliliter).|One month after the second vaccine dose|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, on subjects with available results.||units per milliliter (U/mL)||95% Confidence Interval|Geometric Mean
801104|NCT00969228|Primary|Number of Subjects Seroconverted for Anti-rotavirus Immunoglobulin A|Seroconversion is defined as the appearance of antibodies with concentrations greater than or equal to 20 units per milliliter (U/mL) in the serum of subjects seronegative before vaccination.|One month after the second vaccine dose|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, on subjects with available results.||subjects|||Number
801105|NCT00969280|Secondary|General Assessment||visit 11||||||
801106|NCT00969280|Secondary|Medication Quantification Scale (MQS)||every visit||||||
801107|NCT00969280|Secondary|Tear Film Break-up Time : BUT||Visit 1, 10||||||
801108|NCT00969280|Secondary|Schirmer 1 Test||visit 1,10||||||
801109|NCT00969280|Secondary|Visual Analogue Scale of Self Symptoms||every visit||||||
801125|NCT00969540|Secondary|Sleep Variables (Nighttime Wake-time) Measured With Actigraphy in Patients With Lower Back Pain.|Secondary outcome: Nighttime wake-time after sleep onset with placebo mattress cover compared to active mattress cover.|Assessed daily for 14 days per intervention.|The sponsor determined the number of participants.||Minutes||Standard Deviation|Mean
801430|NCT00972543|Secondary|Complaint Directed Physical Examinations|Number of participants undergoing complaint directed physical examinations|Measure at (Day 0, Day 7, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits)|Results not analysed due to early termination of the study|||||
801110|NCT00969280|Primary|Ocular Surface Disease Index : OSDI|The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants checked at a score between 0 and 4, where 0 equals “none of the time” and 4 equals “all of the time”. OSDI scores will be calculated according to the following formula: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4]. The possible range of the OSDI score is 0 to 100. Mean difference of the OSDI scores was calculated from the OSDI scores between Visit 11 and baseline.|Visit 11 (after 3 weeks from baseline)|Statistical analyses were conducted on an intention-to-treat basis (ITT analysis, significance p<0.05). According to the last observation carried forward method (LOCF method), the last observed missing values were used to complete missing values from drop-out participants.||Scores on the OSDI score|Participants|Standard Deviation|Mean
801111|NCT00969436|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or congenital anomaly/birth defect in the offspring of a study subject.|From the first study dose up to study end (Month 0 to Month 7.5 approximately)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subjects|||Number
801112|NCT00969436|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Event|An unsolicited Adverse Event (AE) covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an AE reported in addition to those solicited during the clinical study. Also any ‘solicited’ symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.|Within 43-day (Days 0-42) after the first and second vaccination dose|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subjects|||Number
801113|NCT00969436|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Rash|Any rash was defined as incidence of a rash regardless of intensity grade or relationship to vaccination and grade 3 rash greater than (>) 150 lesions. Related rash was defined as rash assessed by the investigator as causally related to the vaccination|During the 43-day (Days 0-42) post-vaccination period following each dose (dose 1 and dose 2)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with the symptom sheet filled in.||Subjects|||Number
801114|NCT00969436|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Fever|Any fever was defined as fever ≥ 38.0°C and grade 3 fever > 39.5°C after vaccination. Related fever was defined as fever assessed by the investigator as related to the vaccination.|During the 43-day (Days 0-42) post-vaccination period following each dose (dose 1 and dose 2)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with the symptom sheet filled in.||Subjects|||Number
801115|NCT00969436|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were meningism and parotid gland swelling. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 (G3) meningism and parotid gland swelling = meningism/parotid gland swelling which prevented normal everyday activities. Related (Rel) = symptom assessed by the investigator as related to the vaccination.|During the 43-day (Days 0-42) post-vaccination period following each dose (dose 1 and dose 2)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with the symptom sheet filled in.||Subjects|||Number
801116|NCT00969436|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.|During the 4-day (Days 0-3) post-vaccination period following each dose (dose 1 and dose 2)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with the symptom sheet filled in.||Subjects|||Number
801117|NCT00969436|Secondary|Antibody Concentrations Against Measles, Mumps, Rubella and Varicella Viruses|Antibody concentrations were summarized by geometric mean concentrations (GMCs) with their 95% confidence intervals (CIs)|At 42 – 56 days after the first (at week 6) and second (at week 30) vaccination dose|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all eligible subjects for whom pre-vaccination and post-vaccination serology results were available for antibodies against at least one antigen.||mIU/mL||95% Confidence Interval|Geometric Mean
801118|NCT00969436|Secondary|Number of Seroconverted Subjects for Measles, Mumps, Rubella and Varicella Antibodies|Seroconversion was defined as the appearance of antibodies (i.e. concentration/titre ≥ the cut-off value) in the serum of subjects seronegative before vaccination. The cut-off values for serocoversion were 150 mIU/mL, 231 U/mL, 4 IU/mL and for IgG varicella antibodies 1:4 dilution for measles, mumps, rubella and varicella, respectively.|Approximately 42 to 56 days after the first vaccine dose at week 6|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all eligible subjects for whom pre-vaccination and post-vaccination serology results were available for antibodies against at least one antigen.||Subjects|||Number
801119|NCT00969436|Primary|Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies|Seroconversion was defined as the appearance of antibodies [i.e. concentration/titre greater than or equal to (≥) the cut-off value] in the serum of subjects seronegative before vaccination. The cut-off values for serocoversion were 150 milli-international units per milliliter (mIU/mL), 231 units per milliliter (U/mL), 4 international units per milliliter (IU/mL) and for immunoglobulin G (IgG) varicella antibodies 1:4 dilution for measles, mumps, rubella and varicella, respectively.|At 42 – 56 days after the second vaccination dose at week 30|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all eligible subjects for whom pre-vaccination and post-vaccination serology results were available for antibodies against at least one antigen.||Subjects|||Number
801120|NCT00969501|Primary|Number of Participants With a Reduction in Pain by the Scores.|Greater than 50 percent reduction in pain scores from baseline.|6 months|￼||participants|||Number
801121|NCT00969540|Secondary|Sleep Variables (Sleep Latency) Measured With Actigraphy in Patients With Lower Back Pain.|Secondary outcome: Sleep latency in placebo mattress cover compared to active mattress cover.|Assessed daily for 14 days per intervention.|The sponsor determined the number of participants.||Minutes||Standard Deviation|Mean
801126|NCT00969540|Primary|Optically Modified Polyethylene Terephthalate Fiber Mattress Cover (OMPETFMC) Improves Sleep Quality in Patients With Lower Back Pain as Measured by Clinical Global Impression (CGI).|"The primary outcomes are the change in mean daily Clinical Global Impressions (pain and sleep) in placebo mattress compared to active mattress cover (assessed daily for 14 days per intervention).
The daily scores range from 1 (very much improved) to 7 (very much worse)."|14 days|The sponsor determined the size of the study.||units on a scale||Standard Deviation|Mean
801127|NCT00969618|Secondary|Mean Change From Baseline to 48 Weeks Endpoint in Comorbid, Depressive Symptoms, as Measured by Hamilton Depression Rating Scale-17 (HAMD-17) Items|The HAMD-17 instrument consists of 17 items used to assess the severity of depression and its improvement during the course of therapy. This instrument is completed by the clinician based on his or her assessment of the participant. Each item was evaluated and scored using either a 5-point scale of 0 (not present) to 4 (very severe) or a 3-point scale of 0 (not present) to 2 (marked). The total score is the sum of the scores from HAMD-17 Items 1 through 17 and ranges from 0 (not at all depressed) to 52 (severely depressed). Higher scores indicate greater symptom severity.|Baseline, 48 weeks|All participants who received at least one dose of study drug, and had a baseline and at least one post-baseline HAMD-17 measurement. Last observation carried forward (LOCF) principle was used.||units on a scale||Standard Deviation|Mean
801128|NCT00969618|Secondary|Mean Change From Baseline to 48 Weeks Endpoint in the Behavior Rating Inventory of Executive Function-Adult (BRIEF-A) Version: Informant Scores (BRIEF-A:Informant Scores)|Third-party observer of participant completes 75-item scale. Comprised of 3 subscales. Each item rated on 3-point Likert scale: 1 (behavior never observed) to 3 (behavior often observed). Global executive composite (GEC) subscale rates participant’s GEC in everyday environment (75-225 total score). Behavioral regulation subscale measures participant’s control over behavior (30-90 total score). Metacognition subscale assesses systematic problem-solving ability while sustaining these task-completion efforts in active working memory (40-120 total score). Higher subscale ratings indicate greater perceived impairment.|Baseline, 48 weeks|All participants who received at least one dose of study drug, and had a baseline and at least one post-baseline BRIEF-A Informant scores measurement. Last observation carried forward (LOCF) principle was used.||units on a scale||Standard Deviation|Mean
801129|NCT00969618|Secondary|Mean Change From Baseline to 48 Weeks Endpoint in Clinical Global Impressions-Attention-Deficit/Hyperactivity Disorder-Severity (CGI-ADHD-S)|The CGI-ADHD-S is a single-item rating of the clinician’s assessment of the overall severity of the participant’s ADHD symptoms in relation to the clinician’s total experience with ADHD participants. CGI-ADHD-S measures severity of the participant's overall severity of ADHD symptoms: 1 (normal, not at all ill) to 7 (among the most extremely ill participants).|Baseline, 48 weeks|All participants who received at least one dose of study drug, and had a baseline and at least one post-baseline CGI-ADHD-S measurement. Last observation carried forward (LOCF) principle was used.||units on a scale||Standard Deviation|Mean
801130|NCT00969618|Secondary|Mean Change From Baseline to 48 Weeks Endpoint in Comorbid, Anxiety Symptoms, as Measured by Hamilton Anxiety Rating Scale-14 (HAMA-14) Items|The HAMA-14 instrument consists of 14 items that provide an overall measure of general anxiety, including psychic anxiety and somatic anxiety. This instrument is completed by the clinician based on his or her assessment of the participant. Each item is rated on a 5-point scale of 0 (absent) to 4 (very severe). Total score is the sum of the 14 items and ranges from 0 (normal) to 56 (severe). Higher scores indicate greater anxiety.|Baseline, 48 weeks|All participants who received at least one dose of study drug, and had a baseline and at least one post-baseline HAMA-14 measurement. Last observation carried forward (LOCF) principle was used.||units on a scale||Standard Deviation|Mean
801131|NCT00969618|Secondary|Mean Change From Baseline to 48 Weeks Endpoint in the Behavior Rating Inventory of Executive Function -Adult (BRIEF-A) Version: Self Report (BRIEF-A:Self Report )|A 75-item standardized self-reported measure comprised of 3 subscales. Each item is rated on a 3-point Likert scale: 1 (behavior never observed) to 3 (behavior often observed). Global executive composite (GEC) subscale rates participant’s GEC in everyday environment (75- 225 total score). Behavioral regulation subscale measures participant’s control over behavior (30-90 total score). Metacognition subscale assesses systematic problem-solving ability while sustaining these task-completion efforts in active working memory (40-120 total score). Higher subscale ratings indicate greater perceived impairment.|Baseline, 48 weeks|All participants who received at least one dose of study drug, and had a baseline and at least one post-baseline BRIEF-A self report measurement. Last observation carried forward (LOCF) principle was used.||units on a scale||Standard Deviation|Mean
801132|NCT00969618|Secondary|Mean Change From Baseline to 48 Weeks Endpoint in the Adult Attention-Deficit/Hyperactivity Disorder Quality of Life (AAQoL)-29 Scores|AAQoL is a 29 items participant completed questionnaire rated on a 5-point Likert scale from 1 (Not at all/ Never) to 5 (Extremely/Very Often). AAQoL total (all 29 items) and 4 subscale scores: Life Productivity (11 items); Psychological Health (6 items); Life Outlook (7 items); Relationships (5 items). Total score is computed by (1) reversing scores for all items except the 7 items in the Life Outlook subscale; (2) transforming scores to 0-100 scale (1=0; 2=25; 3=50; 4=75; 5=100); (3) summing item scores and dividing by the item count. Higher total scores indicate better quality of life.|Baseline, 48 weeks|All participants who received at least one dose of study drug, and had a baseline and at least one post-baseline AAQoL measurement. Last observation carried forward (LOCF) principle was used.||units on a scale||Standard Deviation|Mean
801133|NCT00969618|Secondary|Mean Change From Baseline to 48 Weeks Endpoint in the Conners' Adult Attention-Deficit Hyperactivity Disorder Rating Scale-Investigator Rated: Screening Version-Japanese (CAARS-Inv:SV-J)|CAARS-Inv:SV-J is a 30-item scale containing 3 subscales: inattention (9 items), hyperactivity/impulsivity (9 items), and attention deficit hyperactivity disorder (ADHD) Index (12 items). Each item is scored 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Total ADHD symptoms score=sum of the inattention subscales (scores range from 0-27) and hyperactivity/impulsivity subscales (scores range from 0-27) with a total score range of 0-54. The ADHD Index scores range from 0-36. Higher scores indicate greater impairment.|Baseline, 48 weeks|All participants who received at least one dose of study drug, and had a baseline and at least one post-baseline CAARS measurement. Last observation carried forward (LOCF) principle was used.||units on a scale||Standard Deviation|Mean
801134|NCT00969618|Primary|Number of Participants With Adverse Events Leading to Discontinuation||Baseline through 48 weeks|All participants who received at least one dose of study drug.||participant|||Number
801135|NCT00969709|Secondary|Change in Sheehan Disability Scale (SDS) Total Score|The Sheehan Disability Scale (SDS) is a 3-item clinician-rated questionnaire used to evaluate functional impairments in the domains of work, social life/leisure, and family life/home responsibility. All items are rated on an 11-point continuum (0 = no impairment to 10 = most severe) with the total SDS score ranging from 0 (no impairment) to 30 (most severe for all measured symptoms)|From Baseline to Week 8|A total of 724 patients were randomized to receive double-blind treatment (Randomized Population); 713 patients received at least 1 dose of treatment (Safety Population); and 704 patients received at least 1 dose of treatment and had at least 1 postbaseline MADRS-CR assessment(Intent to Treat [ITT] Population).||units on a scale||Standard Error|Mean
801136|NCT00969709|Primary|Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score|"The MADRS was used to assess depressive symptomatology during the past week. Patients are rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest.
Each item of the 10 items are scored on a 7-point scale. A score of 0 indicates the absence of symptoms,and a score of 6 indicates symptoms of maximum severity. The total MADRS score for this measure ranges from 0 (absence of symptoms) to 60 (maximum severity for all measured symptoms)."|From Baseline to Week 8|A total of 724 patients were randomized to receive double-blind treatment (Randomized Population); 713 patients received at least 1 dose of treatment (Safety Population); and 704 patients received at least 1 dose of treatment and had at least 1 postbaseline MADRS-CR assessment (Intent to Treat [ITT] Population).||Units on a scale||Standard Error|Least Squares Mean
801137|NCT00969878|Secondary|•The Immunogenicity of TA-CD;|Peak antibody levels after five vaccinations with TA-CD, which occurred at week 16.|During the 18 weeks study period.|||micrograms/ml||95% Confidence Interval|Mean
801138|NCT00969878|Primary|Cocaine Abstinence During Weeks 9 to 16 Inclusive|Number of patients having at least 2 weeks of cocaine-free urines between weeks 9-16 after vaccination with five doses of TA-CD 400 µg compared to placebo|Over 8 weeks ( Study Weeks 9 to 16 inclusive)|||participants|||Number
801139|NCT00970216|Primary|HBV-DNA < 300 Copies/mL in 48 Weeks||48 weeks|||participants|||Number
801140|NCT00964028|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the whole study period (from Day 0 until Month 3 or Month 4)|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.||Participants|||Count of Participants
801141|NCT00964028|Primary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Days 0-30) follow-up period after each vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.||Participants|||Count of Participants
801142|NCT00964028|Primary|Number of Subjects With Any Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above 37.0 degrees Celsius (°C)]. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination.|During the 4-day (Days 0-3) follow-up period after each dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.||Participants|||Count of Participants
801143|NCT00964028|Primary|Number of Subjects With Any Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.|During the 4-day (Days 0-3) follow-up period after each dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.||Participants|||Count of Participants
801144|NCT00964119|Primary|Skeletal Toxicities Related to the Use of Isotretinoin|Bone Marker measurements to assess skeletal toxicities: Change in Bone specific Alkaline Phosphatase: (BSAP) over 5 months of therapy|Baseline to 5 months post therapy|Pilot observational study; Principal Investigator left sponsoring institution, data analysis not completed. Data analysis based on interim data (12 subjects). No manuscript published. No final analysis expected. Study has been closed with the local IRB and files archived.||U/L||Standard Deviation|Mean
801145|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, very satisfied; 2, satisfied; 3, neutral; 4, unsatisfied; 5, very unsatisfied.|Week 8|ITT||Units on a scale||Standard Deviation|Mean
801146|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product|Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 1, very satisfied; 2, satisfied; 3, neutral; 4, unsatisfied; 5, very unsatisfied.|Week 1, Week 2|ITT||Units on a scale||Standard Deviation|Mean
801147|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up|Measure Description Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, not applicable; 1, very easy; 2, easy; 3, neutral; 4, difficult.|Week 8|ITT. All participants were asked to respond to the questionnaire.||Units on a scale||Standard Deviation|Mean
801148|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up|Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, not applicable; 1, very easy; 2, easy; 3, neutral; 4, difficult.|Week 1, Week 2|ITT. All participants were asked to respond to the questionnaire.||Units on a scale||Standard Deviation|Mean
801149|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment|Subject response to the following question: If you were to choose to continue treatment for your acne, which treatment would you choose? (Yes or No).|Week 8|ITT||Participants|||Number
823784|NCT01175902|Primary|Blood Pressure (BP), Period 2|systolic and diastolic BP measured after treaemt from week 8 to week 12|12 weeks|||mmHg||Standard Deviation|Mean
801154|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Compliance|Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, non-compliant (< 50% of the week); 1, mostly compliant (50-79%); 2, very compliant (80-100%).|Week 1, Week 2|ITT||Units on a scale||Standard Deviation|Mean
801155|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, highly favorable; 2, favorable; 3, neutral; 4, unfavorable; 5, highly unfavorable.|Week 8|ITT||Units on a scale||Standard Deviation|Mean
801156|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products|Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 1, highly favorable; 2, favorable; 3, neutral; 4, unfavorable; 5, highly unfavorable.|Week 1, Week 2|ITT||Units on a scale||Standard Deviation|Mean
801157|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Comparison of Study Products to Products Used in the Past|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, more satisfied; 2, somewhat more satisfied; 3, neither satisfied or dissatisfied; 4, more satisfied; 5, more dissatisfied.|Week 8|ITT||Units on a scale||Standard Deviation|Mean
801158|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Which Study Product is Subject More Satisfied With?|Product Acceptability and Preference Questionnaire was completed by the subject at week 1 and week 2 asking which study product they were more satisfied with: Duac or Epiduo.|Week 1, Week 2|ITT. Some participants missed a visit and therefore were not included in the number of participants analyzed for that visit.||Participants|||Number
801159|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Comfort of Skin|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, very comfortable; 2, comfortable; 3, somewhat comfortable; 4, somewhat uncomfortable; 5, uncomfortable.|Week 8|ITT||Units on a scale||Standard Deviation|Mean
801160|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Comfort of Skin|Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 1, very comfortable; 2, comfortable; 3, somewhat comfortable; 4, somewhat uncomfortable; 5, uncomfortable.|Week 1, Week 2|ITT||Units on a scale||Standard Deviation|Mean
801161|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Ease of Application of Product|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, very easy; 2, easy; 3, neutral; 4, difficult; 5, very difficult.|Week 8|ITT||Units on a scale||Standard Deviation|Mean
801162|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Ease of Application of Product|Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 1, very easy; 2, easy; 3, neutral; 4, difficult; 5, very difficult.|Week 1, Week 2|ITT||Units on a scale||Standard Deviation|Mean
801163|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Severity of Scaling|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.|Week 8|ITT||Units on a scale||Standard Deviation|Mean
801164|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Severity of Scaling|Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.|Week 1, Week 2|ITT||Units on a scale||Standard Deviation|Mean
801165|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Severity of Itching|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.|Week 8|ITT||Units on a scale||Standard Deviation|Mean
801166|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Severity of Itching|Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.|Week 1, Week 2|ITT||Units on a scale||Standard Deviation|Mean
801167|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Severity of Burning|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.|Week 8|ITT||Units on a scale||Standard Deviation|Mean
801168|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Severity of Burning|Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.|Week 1, Week 2|ITT||Units on a scale||Standard Deviation|Mean
801169|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Severity of Dryness|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.|Week 8|ITT||Units on a scale||Standard Deviation|Mean
801170|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Severity of Dryness|Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.|Week 1, Week 2|ITT||Units on a scale||Standard Deviation|Mean
801171|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Severity of Redness|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.|Week 8|ITT||Units on a scale||Standard Deviation|Mean
801172|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Severity of Redness|Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.|Week 1, Week 2|ITT||Units on a scale||Standard Deviation|Mean
801425|NCT00972543|Secondary|Haematology Laboratory Assessments - Haemoglobin|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits|||participants|||Number
801173|NCT00964223|Secondary|Skindex-29 Quality of Life Questionnaire - Global Score|"Skindex-29 Quality of Life (QoL)Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: never to all the time, higher scores for each domain indicate worse effects on QoL. The Global Score ranges from 0 to 100. Higher scores indicate worse QoL for that domain."|Baseline, and Week 8|ITT||Units on a scale||Standard Deviation|Mean
801174|NCT00964223|Secondary|Skindex-29 Quality of Life Questionnaire - Functional Domain|"Skindex-29 Quality of Life (QoL)Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: never to all the time, higher scores for each domain indicate worse effects on QoL. Scores range from 0 to 100. Higher scores indicate worse QoL for that domain."|Baseline, and Week 8|ITT||Units on a scale||Standard Deviation|Mean
801175|NCT00964223|Secondary|Skindex-29 Quality of Life Questionnaire - Emotional Domain|"Skindex-29 Quality of Life (QoL)Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: never to all the time, higher scores for each domain indicate worse effects on QoL. Scores range from 0 to 100. Higher scores indicate worse QoL for that domain."|Baseline, and Week 8|ITT||Units on a scale||Standard Deviation|Mean
801176|NCT00964223|Secondary|Skindex-29 Quality of Life Questionnaire - Symptomatic Domain|"Skindex-29 Quality of Life (QoL) Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: never to all the time, higher scores for each domain indicate worse effects on QoL. Scores range from 0 to 100. Higher scores indicate worse QoL for that domain."|Baseline, and Week 8|ITT||Units on a scale||Standard Deviation|Mean
801177|NCT00964223|Secondary|Total Acne Lesion Counts|Total acne lesion counts - includes both inflammatory acne lesions (pustules, papules), noninflammatory lesions (whiteheads and blackheads),|Week 5, Week 8|ITT||total acne lesions||Standard Deviation|Mean
801178|NCT00964223|Secondary|Non-Inflammatory Acne Lesion Counts|Total number of non-inflammatory acne lesions (whiteheads and blackheads) at each timepoint.|Week 5, Week 8|ITT||non-inflammatory acne lesions||Standard Deviation|Mean
801179|NCT00964223|Secondary|Inflammatory Acne Lesion Counts|Total number of inflammatory acne lesions (pustules, papules) at each timepoint.|Week 5, Week 8|ITT||inflammatory acne lesions||Standard Deviation|Mean
801180|NCT00964223|Secondary|Investigator Static Global Assessment Score|ISGA is evaluated using the following scale: 0, clear, clear skin with no lesions; 1, almost clear, rare non-inflammatory lesions; 2, mild, some non-inflammatory lesions with no more than a few inflammatory lesions but no nodular lesions; 3, moderate, up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than 1 small nodular lesion; 4, severe, up to many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions; 5, very severe, many non-inflammatory and inflammatory lesions and more than a few nodular lesions. May have cystic lesions.|Week 5, Week 8|ITT||Units on a scale||Standard Deviation|Mean
801181|NCT00964223|Secondary|Irritant/Allergic Contact Dermatitis Score|Investigator assessment of tolerability (contact dermatitis) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.|Week 5, Week 8|ITT||Units on a scale||Standard Deviation|Mean
801182|NCT00964223|Secondary|Skin Peeling Score|Investigator assessment of tolerability (skin peeling) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.|Week 5, Week 8|ITT||Units on a scale||Standard Deviation|Mean
801183|NCT00964223|Secondary|Skin Dryness Score|Investigator assessment of tolerability (skin dryness) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.|Week 5, Week 8|ITT||Units on a scale||Standard Deviation|Mean
801184|NCT00964223|Secondary|Erythema (Redness) Score|Investigator assessment of tolerability (erythema) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.|Week 5, Week 8|ITT||Units on a scale||Standard Deviation|Mean
801185|NCT00964223|Primary|Erythema (Redness) Score|Investigator assessment of tolerability (irritant/allergic contact dermatitis) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.|Week 1, Week 2|ITT||Units on a scale||Standard Deviation|Mean
801186|NCT00964223|Primary|Irritant/Allergic Contact Dermatitis Score|"Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis) on the face.
Erythema,peeling, and dryness were graded using the following scale:
0 None
Slight
Moderate
Intense"|Week 1, Week 2|ITT||Units on a scale||Standard Deviation|Mean
801187|NCT00964223|Primary|Skin Peeling Score|Investigator assessment of tolerability (skin peeling) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; Intense, 3.|Week 1, Week 2|ITT||Units on a scale||Standard Deviation|Mean
801188|NCT00964223|Primary|Skin Dryness Score|Investigator assessment of tolerability (skin dryness) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.|Week 1, Week 2|Intent-to-Treat (ITT) Population||Units on a scale||Standard Deviation|Mean
801189|NCT00964366|Secondary|Skin Hydration|Evaluation of Skin Hydration using electrical conductance measurements,on weekdays during 14 days of treatment. The value recorded which is expressed in units of microsiemens represents the AC conductance 2-3 seconds after placing the spring-loaded probe tip to the sample site.|2 weeks|ITT||Microsiemens||Standard Deviation|Mean
801190|NCT00964366|Secondary|Sebum Measurements|To sample the skin surface, the sebum collector strips are applied to the skin sites for 10 seconds. Once removed, these samples will be immediately measured for the amount of sebum on the strip using the tape analyzer. The amount of sebum production was measured as the amount of sebum collected on a tape applied to the skin for 10 seconds and then converted to 1 of 10 incremental levels. Sebum production was measured in increments of 0 (minimum value) to 10 (maximum value). The higher the number, the greater amount of sebum produced.|2 weeks|ITT||units on a scale||Standard Deviation|Mean
801426|NCT00972543|Secondary|Weight Measurements||Measured at Screening, Day 0, Day 7, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits|Results not analysed due to early termination of the study|||||
801191|NCT00964366|Primary|Skin Dryness|"The amount of dryness on the left and right cheek of each panelist.
The scale used to evaluate skin dryness is:
Grade Description 0 None 2 Slight flaking 4 Moderate flaking/scaling 6 Marked scaling / slight fissuring 8 Severe scaling, fissuring
Expert Grader assessments of dryness were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14."|Baseline, Day 1through Day 14|ITT||Units on a scale||Standard Deviation|Mean
801192|NCT00964366|Secondary|Transepidermal Water Loss (TEWL)|To assess skin moisture and hydration using transepidermal water loss (TEWL). These tables record the data obtained for each panelist at Baseline, and on Days 3, 7 and 14 or upon early termination of site(s), if applicable. Results are measured on a continuous scale.|2 Weeks|||TEWL rates (gm/m2/hr)||Standard Deviation|Mean
801193|NCT00964366|Primary|Skin Erythema (Redness)|"Assessment of erythema as part of an evaluation of tolerance of two treatments: clindamycin and benzoyl peroxide or dapsone gel. This was done by visual assessment by an independent blinded grader using the grading scale shown below.
Grade Description 0 None 2 Mild erythema 4 Moderate confluent erythema 6 Marked erythema with some edema 8 Marked erythema, edema, possible erosion"|2 Weeks|ITT||Units on a scale||Standard Deviation|Mean
801194|NCT00964392|Secondary|Percentage of Subjects Experienced Serious Adverse Events.|The occurrence of serious adverse events (SAE) was used to provide the prospective long-term safety data. The SAEs are summarized by the following time periods: 0 to 30 days post-ablation, 31 days to 365 post-ablation, 366 to 730 days post-ablation, and more than 730 days post-ablation. One subject might have experienced SAEs in more than one time periods. This report covers the SAEs occurred from September 29, 2009 (first patient enrolled) to June 23, 2015 (data download date for this report).|First study day to 5 year post-ablation|Safety population, which is defined as those subjects who underwent study catheter insertion. However subject LUC-030, who experienced one SAE, was excluded from this analysis since the subject discontinued prior to RF ablation.||percentage of participants|||Number
801195|NCT00964392|Primary|The Percentage of Subjects Experiencing Primary Adverse Events Within Seven Days of the Ablation Procedure.|The primary adverse events (AE) include Death, Myocardial infarction (MI), Pulmonary vein (PV) stenosis, Diaphragmatic paralysis, Atrio-esophageal fistula, Transient ischemic attack (TIA), Stroke/Cerebrovascular accident (CVA), Thromboembolism, Pericarditis, Cardiac tamponade, Pericardial effusion, Pneumothorax, Atrial perforation, Vascular access complications, Pulmonary edema, Hospitalization (including initial and prolonged, excluding those hospitalizations solely due to pre-existing arrhythmia recurrence), Heart block. Pulmonary vein stenosis (defined as ≥70% diameter reduction) and atrio-esophageal fistula occurring more than 7 days post-procedure shall be deemed a Primary AE. The primary endpoint for the Post-Approval Registry is a comparison of the 7-day primary AE rate against a performance criterion of 16 %. The 16% performance criterion is based on literature data and discussion with the FDA per IDE G030236.|Seven days post ablation procedure|Safety population, which is defined as those subjects who underwent study catheter insertion. However subject LUC-030, who experienced one primary AE, was excluded from this analysis since the subject discontinued prior to RF ablation.||percentage of participants||95% Confidence Interval|Number
801196|NCT00964431|Primary|Total Patient Pain Relief Over 0 to 8 Hours.|"Total patient pain relief was assessed as a time-weighted sum of the patient pain assessments at each individual time point from 0-8 hours.
Values for TOTPAR are measured from 0 to 4 on the Pain Relief Scale 0 None Min; 1 A little; 2 Some; 3 A lot; 4 Complete Max
The TOTPAR is a weighted measure of the observations; the minimum possible value is 0 and the maximum possible value is 32."|8 hours|||units on a scale||95% Confidence Interval|Least Squares Mean
801197|NCT00970268|Secondary|Change From Baseline in Peak FEV1|Change From Baseline (Visit 2 of study NCT00891462, [LAS-MD-33])in Peak FEV1 in liters at Week 52 (Week 64 from the start of NCT00891462, [LAS-MD-33]).|52 weeks|||L||Standard Error|Least Squares Mean
801198|NCT00970268|Primary|Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1)|Change From Baseline (Visit 2 of lead-in Study NCT00891462, [LAS-MD-33]) to Week 52 (Week 64 From Start of NCT00891462, [LAS-MD-33]) in Morning Predose (Trough) FEV1|Change from baseline (visit 2 of lead-in study LAS-MD-33) to 52 weeks|From the total of 291 patients enrolled, 289 patients (99.3%) received at least 1 dose of double-blind treatment and therefore were included in the Safety Population. Of these patients, 246 (84.5%) had a baseline and at least 1 postbaseline FEV1 assessment and qualified for the ITT Population||L||Standard Error|Least Squares Mean
801199|NCT00970281|Secondary|Percentage of Participants With Treatment-Emergent Extrapyramidal Symptoms Based on the Drug Induced Extrapyramidal Symptoms Scale (DIEPSS) Score up to 24 Hours After the First Intramuscular (IM) Injection|Assesses extrapyramidal symptoms attributable to antipsychotics. Consists of 9 items (8 to assess individual symptoms; 1 to assess global severity). Each item is assessed from 0 (none, normal) to 4 (severe). Total points of 8 items are defined as DIEPSS total (0 to 32 points). Items for assessment of individual symptoms are classified into 4 categories of parkinsonism, akathisia, dystonia and dyskinesia. Parkinsonism is assessed by total points of items 1 to 5; akathisia, dystonia and dyskinesia are assessed by points given to corresponding items (item 6, item 7, and item 8, respectively).|Up to 24 hours after the first IM injection|Participants with an abnormal value at post-baseline, last observation carried forward (LOCF).||percentage of participants|||Number
801200|NCT00970281|Secondary|Percentage of Participants With Scores of 4 to 7 in the Agitation-Calmness Evaluation Scale (ACES) Score up to 24 Hours After the First Intramuscular (IM) Injection|The ACES differentiates agitation, calmness, and sleep-state, using a 9-point scale: 1 (Marked Agitation) to 9 (Unarousable). Scores of 4 (Normal) to 7 (Marked Calmness) were used for this outcome measure.|up to 24 hours after the first IM injection|Participants having a post-baseline measure, last observation carried forward (LOCF).||percentage of participants|||Number
801201|NCT00970281|Secondary|Percentage of Participants With 40% or Greater Percent Decrease in the Positive and Negative Syndrome Scale - Excited Component (PANSS-EC) Total Score up to 2 Hours After the First Intramuscular (IM) Injection|Measures excitability and consists of the following 5 items from the PANSS: Excitement, Hostility, Tension, Uncooperativeness, and Poor Impulse Control. Each item is rated on a scale from 1 (absent) to 7 (extreme). The sum of the 5 items is defined as the PANSS-EC total score which ranges from 5 to 35.|Up to 2 hours after the first (IM) injection|Full analysis set (FAS): All randomized participants administered at least 1 intramuscular (IM) injection of the investigational product with at least 1 observation after the first IM injection, last observation carried forward (LOCF).||percentage of participants|||Number
823785|NCT01175902|Primary|Blood Pressure (BP), Period 1|systolic and diastolic BP at 4 weeks after use of eyedrops|4 weeks|||mmHg||Standard Deviation|Mean
801202|NCT00970281|Secondary|Change From Baseline in the Positive and Negative Syndrome Scale - Excited Component (PANSS-EC) Total Score up to 24 Hours After the First Intramuscular (IM) Injection|Measures excitability and consists of the following 5 items from the PANSS: Excitement, Hostility, Tension, Uncooperativeness, and Poor Impulse Control. Each item is rated on a scale from 1 (absent) to 7 (extreme). The sum of the 5 items is defined as the PANSS-EC total score which ranges from 5 to 35.|Baseline, up to 24 hours after first IM injection|Full analysis set (FAS): All randomized participants administered at least 1 intramuscular (IM) injection of the investigational product with at least 1 observation after the first IM injection, last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
801203|NCT00970281|Secondary|Change From Baseline in PANSS-EC Total Score up to 90 Minutes After the First Intramuscular (IM) Injection|Measures excitability and consists of the following 5 items from the PANSS: Excitement, Hostility, Tension, Uncooperativeness, and Poor Impulse Control. Each item is rated on a scale from 1 (absent) to 7 (extreme). The sum of the 5 items is defined as the PANSS-EC total score which ranges from 5 to 35.|Baseline, 15 minutes, 30 minutes, 60 minutes, and 90 minutes after the first injection|Full analysis set (FAS): All randomized participants administered at least 1 intramuscular (IM) injection of the investigational product with at least 1 observation after the first IM injection, last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
801204|NCT00970281|Primary|Change From Baseline in the Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) Total Score up to 2 Hours After the First Intramuscular (IM) Injection|Measures excitability and consists of the following 5 items from the PANSS: Excitement, Hostility, Tension, Uncooperativeness, and Poor Impulse Control. Each item is rated on a scale from 1 (absent) to 7 (extreme). The sum of the 5 items is defined as the PANSS-EC total score which ranges from 5 to 35.|Baseline, up to 2 hours after first IM injection|Participants with a baseline and a value at the time, last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
801205|NCT00970294|Secondary|Glycemic Control|HbA1c measure|Baseline and at 10 weeks (change score)|||percentage of glycosolated hemoglobin||Standard Deviation|Mean
801206|NCT00970294|Secondary|Aerobic Fitness|peak VO2 as measured with a graded maximal exercise test on a cycle ergometer|Baseline and at 10 weeks (change score)|||mL/kg/m||Standard Deviation|Mean
801207|NCT00970294|Primary|Recruitment, Retention, Adherence|% of enrolled subjects who completed the trial|10 weeks|||percentage of participants|||Number
801208|NCT00970307|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.|During the entire study period (from Month 0 to Month 3)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.||Participants|||Count of Participants
801209|NCT00970307|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE was any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31-day (Days 0-30) post-vaccination period after any vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.||Participants|||Count of Participants
801210|NCT00970307|Secondary|Number of Subjects With Any Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever (defined as axillary temperature ≥ 37.5°C). Any= incidence of a general symptom irrespective of intensity grade and relationship to vaccination.|During the 8-day (Days 0-7) post-vaccination period after any vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available and had the symptom sheets filled in.||Participants|||Count of Participants
801211|NCT00970307|Secondary|Number of Subjects With Any Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = incidence of a local symptom irrespective of intensity grade.|During the 8-day (Days 0-7) post-vaccination period after any vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available and had the symptom sheets filled in.||Participants|||Count of Participants
801212|NCT00970307|Secondary|Anti-PD Antibody Concentrations|Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 100 EL.U/mL.|At Month 3|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.||EL.U/mL||95% Confidence Interval|Geometric Mean
801213|NCT00970307|Secondary|Number of Seropositive Subjects for Anti-protein D (Anti-PD)|A seropositive subject was defined as a subject with anti-PD concentrations ≥ 100 EL.U/mL.|At Month 3|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.||Participants|||Count of Participants
801214|NCT00970307|Secondary|Anti-pneumo Antibody Concentrations|Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 0.05 µg/mL.|At Month 3|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.||µg/mL||95% Confidence Interval|Geometric Mean
801215|NCT00970307|Secondary|Number of Seropositive Subjects for Anti-pneumococcal (Anti-pneumo) Serotypes|A seropositive subject was defined as a subject with anti-pneumo concentrations ≥ 0.05 µg/mL. The anti-pneumo serotypes assessed were: 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.|At Month 3|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.||Participants|||Count of Participants
801216|NCT00970307|Secondary|Anti-polio Types 1, 2 and 3 Antibody Titers|Titers were expressed as geometric mean titers (GMTs) for the seroprotection cut-off value of ≥ 1:8.|At Month 3|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.||Titers||95% Confidence Interval|Geometric Mean
801217|NCT00970307|Secondary|Number of Seroprotected Subjects for Anti-poliovirus (Anti-polio) Types 1, 2 and 3|A seroprotected subject was defined as a subject with anti-polio type 1, 2 or 3 antibody titers ≥ 1:8.|At Month 3|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.||Participants|||Count of Participants
801218|NCT00970307|Secondary|Anti-HBs Antibody Concentrations|Antibody concentrations were expressed as GMCs. The seroprotection cut-off used was of ≥ 10 mIU/mL. A decrease in the specificity of the anti-HB ELISA had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the CLIA approved by the FDA. The table shows updated results following partial or complete retesting/reanalysis.|At Month 3|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.||mIU/mL||95% Confidence Interval|Geometric Mean
801219|NCT00970307|Secondary|Number of Seroprotected and Seropositive Subjects for Anti-hepatitis B Surface Antigen (Anti-HBs)|A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL. A seropositive subject was defined as a subjects with anti-HBs antibody concentrations ≥ 3.3 mIU/mL. A decrease in the specificity of the anti-HB ELISA had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis.|At Month 3|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.||Participants|||Count of Participants
801220|NCT00970307|Secondary|Number of Subjects With a Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN|A subject with a vaccine response was defined as either an initially seronegative subject with anti-PT, anti-FHA or anti-PRN concentrations ≥ 5 EL.U/mL or an initially seropositive subjects with antibody concentrations one month after the primary vaccination ≥ 1 fold the-pre vaccination antibody concentration.|At Month 3|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.||Participants|||Count of Participants
801221|NCT00970307|Secondary|Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations|Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 5 EL.U/mL.|At Months 0 and 3|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.||EL.U/mL||95% Confidence Interval|Geometric Mean
801222|NCT00970307|Secondary|Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)|A seropositive subject was defined as a subject with anti-PT, anti-FHA or anti-PRN concentrations ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).|At Month 3|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.||Participants|||Count of Participants
801223|NCT00970307|Secondary|Anti-D and Anti-T Antibody Concentrations|Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off value of ≥ 0.1 IU/mL.|At Month 3|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.||IU/mL||95% Confidence Interval|Geometric Mean
801224|NCT00970307|Secondary|Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T)|A seroprotected subject was defined as a subject with anti-D or anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).|At Month 3|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.||Participants|||Count of Participants
801225|NCT00970307|Secondary|Anti-PSC Antibody Concentrations|Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 0.3 µg/mL.|At Months 0 and 3|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.||µg/mL||95% Confidence Interval|Geometric Mean
801226|NCT00970307|Secondary|Number of Seropositive Subjects for Anti-polysaccharide Neisseria Meningitidis Serogroup C (Anti-PSC)|A seropositive subject was defined as a subject with anti-PSC antibody concentration ≥ 0.3 µg/mL.|At Month 3|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.||Participants|||Count of Participants
801427|NCT00972543|Secondary|Temperature||Measure at Day 0, Day 7, Week 8, Week 16 and Follow Up and Early Termination visits|Results not analysed due to early termination of the study|||||
801227|NCT00970307|Secondary|Antibody Titers Against rSBA-MenC|The seroprotection cut-off value of the assay was an antibody titer ≥ 1:8.|At Months 0 and 3|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.||Titers||95% Confidence Interval|Geometric Mean
801228|NCT00970307|Secondary|Anti-PRP Antibody Concentrations|Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off value of ≥ 0.15 µg/mL.|At Months 0 and 3|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.||µg/mL||95% Confidence Interval|Geometric Mean
801229|NCT00970307|Primary|Number of Seroprotected Subjects Against Neisseria Meningitidis Serogroup C Using Baby Rabbit Complement (rSBA-MenC)|A seroprotected subject was defined as a subject with rSBA-MenC titers greater than or equal to (≥) 1:8.|At Month 3|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.||Participants|||Count of Participants
801230|NCT00970307|Primary|Number of Seroprotected Subjects Against Polyribosyl-Ribitol-Phosphate (PRP)|A seroprotected subject was defined as a subject with anti-PRP antibody concentrations greater than or equal to (≥) 0.15 micrograms per milliliter (µg/mL).|At Month 3|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.||Participants|||Count of Participants
801231|NCT00970320|Secondary|Change in Manometry Measurements|manometric measurements of pelvic floor muscle strength and anal sphincter length during voluntary pelvic floor muscle contraction|12 to 24 months postpartum||||||
801232|NCT00970320|Secondary|Change in Pelvic Floor Muscle Function Test as Measured on the ICS Scale|Digital palpation and grading of voluntary pelvic floor muscle contraction (1=absent, 2=weak, 3=normal, 4=strong).|12 to 24 months postpartum||||||
801233|NCT00970320|Secondary|Fecal Incontinence of Life (FIQL) Scale|Change in health-related quality of Life as measured on the fecal incontinence quality of life scale (FIQL). There is no total scale, only four sub scales ranging from 4 (complete continence, no impact on QoL) to 1 (complete incontinence, severe impact on QoL) Data from the postpartum period has not and will not be analysed due to low numbers.|0 to 24 months postpartum||||||
801234|NCT00970320|Secondary|Change in Urinary Incontinence as Measured on ICI-Q UI SF|"International Consultation of Incontinence Questionnaire, short form (ICI-Q SF) ranges from 0 (Complete continence) to 21 (Complete incontinence) and measures the frequency of UI, amount of leakage and impact on quality of life.
Data have not been analysed."|0 to 24 months postpartum||||||
801235|NCT00970320|Primary|Change in Anal Incontinence as Measured on the St. Mark's Score|Survey and interview using the questionnaire St. Mark's incontinence score ranging from 0 (no incontinence) -24 (complete incontinence) points for measuring anal incontinence (AI). The A total of 1069 women responded to the questionnaires at 6 months postpartum and 1031 at 12 months postpartum. Discrepancies in the number of included and analysed participants in the PFME trials are related to the number of women who did not attend the follow-up appointments as described in the published paper.|0 to 24 months postpartum|||units on a scale||Standard Deviation|Mean
801236|NCT00970359|Secondary|Change From Baseline in Serum Thyroglobulin Levels After Treatment With 131I|Will perform a Wilcoxon signed rank test for paired samples to compare the serum thyroglobulin level before and after 131I treatment in the subset of patients treated with 131I following AZD6244.|At 2 months and 6 months after Radioiodine administration|Only patients treated with Radioiodine.||percentage of reduction of levels||Full Range|Mean
801237|NCT00970359|Primary|Tumor Response Defined as Either a Complete Response or Partial Response|as defined by the RECIST v1.1 criteria Descriptive statistics will be used to summarize the data.|6 months|Only patients treated with radioiodine.||participants|||Number
801238|NCT00970359|Primary|Number of Patients Whose Tumor(s) Acquire an Increased Propensity for Iodine Uptake as Detected on Iodine-124 Positron Emission Tomography Scan||2 years|||participants|||Number
801239|NCT00970489|Secondary|Other Endpoints|"Number of days in the ICU, of telemetry monitoring, and of total hospital stay.
Non-AF arrhythmias of at least 30 sec duration, including non-AF-SVT, ventricular tachycardia (VT), and ventricular flutter (VF), assessed and adjudicated by the Events Committee.
MACE: Combined total mortality, myocardial infarction, and stroke.
Bleeding, assessed by (a) chest tube output in the 24 hour period following surgery and (b) total number of packed red blood cell (RBC) transfusions from enrollment to end of treatment (hospital discharge or post-op day 10).
Significant adverse events: Discontinuation of study treatment, at the discretion of the treating physicians, for suspected significant allergic reaction, severe gastrointestinal intolerance, significant bleeding, or other side effects requiring discontinuation.
Thirty-day mortality assessed
One-year mortality assessed"|up to 10 days post-surgery or discharge, whichever sooner|||Participants|||Number
801240|NCT00970489|Secondary|Other Arrhythmias|"The first 3 suspected episodes of atrial fibrillation or flutter of at least 30 sec duration following randomization were documented, including the following information:
Printed or digital rhythm strip and/or 12-lead ECG.
Recording of time of onset and time of cessation.
Additional documentation of temporally associated signs of symptoms, such as new or worsening chest pain, shortness of breath, or lightheadedness; drop in blood pressure requiring escalation of fluid or pressor treatment; or need for electrical or pharmacologic cardioversion.
The first suspected episode of each of other supraventricular or unknown narrow-complex tachycardia of at least 30 sec duration following randomization was also documented."|up to 10 days post-surgery or discharge, whichever sooner|||Participants|||Number
801285|NCT00971048|Secondary|Moist Wound Environment as Per the Bates-Jensen Wound Assessment Tool (BWAT)|Modified Bates-Jensen Wound Assessment (BWAT-m) Scores for those characteristics measured (wound exudate type and amount) were each graded on a 5-point scale, with 1 being the best and 5 being the worst.|At every visit: Day 8, Day 15, Day 22, Day 29|||BWAT-m Exudate Score||Standard Error|Least Squares Mean
801241|NCT00970489|Secondary|Post-op Af|Secondary AF endpoints included post-op AF that was sustained (>1 hour), symptomatic, or treated with pharmacological or electrical cardioversion; post-op AF excluding atrial flutter; time to first post-op AF; and the number of post-op AF episodes per patient. OPERA also evaluated the total number of in-hospital days in which any post-op AF, including sustained post-op AF, was present; and the proportion of in-hospital days free of any post-op AF. All potential episodes of post-op AF and other tachyarrhythmias were reviewed and adjudicated by a centralized Events Committee of cardiac electrophysiologists. Additional endpoints included resource utilization, major adverse cardiovascular events (MACE), arterial thromboembolism, and 30-day mortality.|up to 10 days post-surgery or discharge, whichever sooner|||Participants|||Number
801242|NCT00970489|Primary|Any First Post-op Atrial Fibrillation or Flutter (AF)|Primary: Occurrence of post-CS AF (atrial fibrillation or flutter) of at least 30 seconds duration and confirmed by rhythm strip or 12-lead ECG. This will include definite AF and probable AF (SVT likely to be AF depending on rate and other characteristics).|up to 10 days post-surgery or discharge, whichever sooner|||Participants|||Number
801243|NCT00970502|Secondary|Locoregional Control, Progression-free Survival, Overall Survival and Late Toxicity|At a median follow-up of 11 months, the 1 year locoregional control, progression-free survival, and overall survival rates.|1 year|||percentage of participants|||Number
801244|NCT00970502|Secondary|Locoregional Progression|Patients with locoregional and/or distant progression|20 months|||participants|||Number
801245|NCT00970502|Secondary|Clinical Response|Response to Concurrent Erlotinib, Celecoxib, and Reirradiation according to Response Evaluation Criteria in Solid Tumors - Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions|20 months|||Participants|||Count of Participants
801246|NCT00970502|Primary|Toxicity|Number of participants with acute and late toxicity|30 DAYS|Erlotinib and celecoxib were administered orally||participants|||Number
801247|NCT00970606|Primary|Hospital Mortality to Day 28 or if Mortality is Not Different Between Groups, Time to Achieve Resolution of Respiratory Failure (e.g., Time to Unassisted Breathing in Survivors (Including Patient's Never Requiring Mechanical Ventilation).|No outcome analyses were run as the sample size was not of sufficient size for a comparison with only 7 of >2000 participants planned/anticipated actually enrolled.|28 days|Only 7 participants were enrolled in this study designed for >2000. No formal anlaysis of outcomes was performed as tne n was too small to show any differences|||||
801248|NCT00970632|Secondary|Change From Baseline in Postvoid Residual Volume (PVR) at 12 Weeks|PVR was the amount of urine remaining in the bladder after void completion.|Baseline, 12 weeks|The analysis population included all randomized participants who started study medication, and had non-missing data at baseline and at endpoint (last non-missing post-baseline value).||milliliter (mL)||Standard Deviation|Median
801249|NCT00970632|Secondary|Change From Baseline in Volume of Voided Urine (V-Comp) at 12 Weeks|V-comp (volume of urine voided) was measured in milliliters (mL) using a standard calibrated flowmeter. At each visit, a uroflowmetry assessment was considered valid and data were included in the analyses only if the prevoid total bladder volume (assessed by ultrasound) was ≥150 to ≤550 mL and V-comp was ≥125 mL.|Baseline, 12 weeks|The analysis population included all randomized participants who started study medication, and had non-missing data at baseline and at endpoint (last non-missing post-baseline value).||milliliter (mL)||Standard Deviation|Median
801250|NCT00970632|Secondary|Change From Baseline in Mean Urine Flow Rate (Q-Mean) at 12 Weeks|Q-mean (mean urine flow rate) was measured in milliliters per second (mL/sec) using a standard calibrated flowmeter. At each visit, a uroflowmetry assessment was considered valid and data were included in the analyses only if the prevoid total bladder volume (assessed by ultrasound) was ≥150 to ≤550 mL and the voided volume (V-comp) was >=125 mL.|Baseline, 12 weeks|The analysis population included all randomized participants who started study medication, and had non-missing data at baseline and at endpoint (last non-missing post-baseline value).||milliliters per second (mL/sec)||Standard Deviation|Median
801251|NCT00970632|Secondary|Change From Baseline in Peak Urine Flow Rate (Q-Max) at 12 Weeks|Q-max (peak urine flow rate) was measured in milliliters per second (mL/sec) using a standard calibrated flowmeter. At each visit, a uroflowmetry assessment was considered valid and data were included in the analyses only if the prevoid total bladder volume (assessed by ultrasound) was ≥150 to ≤550 mL and the voided volume (V-comp) was ≥125 mL.|Baseline, 12 weeks|The analysis population included all randomized participants who started study medication, and had non-missing data at baseline and at endpoint (last non-missing post-baseline value).||milliliters per second (mL/sec)||Standard Deviation|Median
801252|NCT00970632|Secondary|Change From Baseline in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain at 12 Weeks|IIEF measured self-reported EF over the past 4 weeks. Scores ranged from 0 (low or no EF)-5 (high EF) on 6 questions (1-5, 15 of the IIEF). Total EF Domain scores ranged from 1-30. Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.|Baseline, 12 weeks|The analysis population included all randomized sexually active participants with erectile dysfunction who started study medication, and had baseline and at least 1 post-baseline measurement.||units on a scale||Standard Error|Least Squares Mean
801253|NCT00970632|Secondary|Treatment Satisfaction Scale - Benign Prostatic Hyperplasia (TSS-BPH) at 12 Weeks: Overall|The TSS-BPH was a validated participant-rated instrument that measured participant satisfaction with treatment based on a 13-item questionnaire. The overall TSS-BPH score was converted to a percentage of the maximum value possible (percent ranged from 0-100) with lower scores indicating greater satisfaction.|12 weeks|The analysis population included all participants who were randomized, started study medication, and had non-missing data at baseline and at least one post-baseline measurement.||units on a scale||Standard Deviation|Median
801286|NCT00971048|Secondary|Pain Assessed by a 100-mm VAS Scale.|100-mm VAS scale was used to evaluate pain, with 1 being healthy tissue (no pain) up to 100 (wound degeneration and severe pain)|At every visit: Day 8, Day 15, Day 22, Day 29|Intent-to-Treat||VAS Pain Scores||Standard Error|Least Squares Mean
801287|NCT00971048|Secondary|Number of Participants With Wound Closure by Day 22.||22 days|||Subjects|||Number
801254|NCT00970632|Secondary|Clinician Global Impression of Improvement (CGI-I) at 12 Weeks|"The CGI-I was an investigator-rated instrument that measured improvement or worsening of the participant’s symptoms based on a 7-point scale. A score of 1=participant felt symptoms were “very much better”; score of 2=participant felt symptoms were much better; score of 3=participant felt symptoms were a little better; score of 4=participant felt “no change” in symptoms; score of 5=participant felt symptoms were a little worse; score of 6=participant felt symptoms were much worse; score of 7=participant felt symptoms were “very much worse”."|12 weeks|The analysis population included all participants who were randomized, started study medication, and had non-missing data.||participants|||Number
801255|NCT00970632|Secondary|Patient Global Impression of Improvement (PGI-I) at 12 Weeks|"The PGI-I was a participant-rated instrument that measured the improvement or worsening of the participant’s symptoms based on a 7-point scale at Week 12. A score of 1=participant felt symptoms were “very much better”; score of 2=participant felt symptoms were much better; score of 3=participant felt symptoms were a little better; score of 4=participant felt “no change” in symptoms; score of 5=participant felt symptoms were a little worse; score of 6=participant felt symptoms were much worse; score of 7=participant felt symptoms were “very much worse”."|12 weeks|The analysis population included all participants who were randomized, started study medication, and had non-missing data.||participants|||Number
801256|NCT00970632|Secondary|Change From Baseline in Benign Prostatic Hyperplasia Impact Index (BII) at 12 Weeks|BII was a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores ranged from 0-13; higher scores represented increased perceived impact of BPH-lower urinary tract symptoms (LUTS) on overall health. Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.|Baseline, 12 weeks|The analysis population included all participants who were randomized, started study medication, and had non-missing data at baseline and at least 1 post-baseline measurement.||units on a scale||Standard Error|Least Squares Mean
801257|NCT00970632|Secondary|Change From Baseline in Benign Prostatic Hyperplasia Impact Index (BII) at 4 Weeks|BII was a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores ranged from 0-13; higher scores represented increased perceived impact of BPH-lower urinary tract symptoms (LUTS) on overall health. Least Squares (LS) Mean of change from baseline to endpoint (Week 4 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.|Baseline, 4 weeks|The analysis population included all participants who were randomized, started study medication, and had non-missing data at baseline and at least 1 post-baseline measurement.||units on a scale||Standard Error|Least Squares Mean
801258|NCT00970632|Secondary|Change From Baseline in Modified International Prostate Symptom Score (mIPSS) at 1 Week|The mIPSS Total Score covered a time period of 1 week and was obtained by combining scores of responses to Component Questions 1-7. Each question was scored from 0-5 for an mIPSS range of 0-35 points; higher numerical scores represented greater severity of symptoms. Least Squares (LS) Mean of change from baseline to endpoint (Week 1 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.|Baseline, 1 week|The analysis population included all participants who were randomized, started study medication, and had non-missing data at baseline and at least 1 post-baseline measurement.||units on a scale||Standard Error|Least Squares Mean
801259|NCT00970632|Secondary|Change From Baseline in International Prostate Symptom Score (IPSS) Quality of Life (QoL) Index at 12 Weeks|IPSS QoL assessed QoL by urinary symptoms, with scores ranging from 0 (delighted)-6 (terrible). Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.|Baseline, 12 weeks|The analysis population included all participants who were randomized, started study medication, and had non-missing data at baseline and at least 1 post-baseline measurement.||units on a scale||Standard Error|Least Squares Mean
801260|NCT00970632|Secondary|Change From Baseline in International Prostate Symptom Score (IPSS) Nocturia Question at 12 Weeks|The IPSS nocturia question (Component Question 7) measured nocturia (need to urinate at night) over the past 4 weeks. Scores ranged from 0 (no episodes of nocturia)-5 (5 or more episodes of nocturia). Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.|Baseline, 12 weeks|The analysis population included all participants who were randomized, started study medication, and had non-missing data at baseline and at least 1 post-baseline measurement.||units on a scale||Standard Error|Least Squares Mean
801261|NCT00970632|Secondary|Change From Baseline in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore at 12 Weeks.|IPSS voiding (obstructive) subscore was the sum of Component Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores ranged from 0 (no obstructive symptoms)-5 (frequent obstructive symptoms); therefore, the 4 questions of the obstructive score ranged from 0-20. Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.|Baseline, 12 weeks|The analysis population included all participants who were randomized, started study medication, and had non-missing data at baseline and at least 1 post-baseline measurement.||units on a scale||Standard Error|Least Squares Mean
801288|NCT00971048|Primary|Adequate Management of the Wound Assessed by a Left Movement (Improvement) in the Modified Bates Jensen Wound Assessment Tool.|Modified Bates-Jensen Wound Assessment (BWAT-m) Scores for those characteristics measured (wound size, depth, edges, undermining, necrotic tissue type and amount, exudate type and amount, periwound color and edema, granulation tissue, and epithelialization) were each graded on a 5-point scale, with 1 being the best and 5 being the worst.|22 - 29 days|Intent-to-Treat||units on a scale||Standard Error|Least Squares Mean
801262|NCT00970632|Secondary|Change From Baseline in International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore at 12 Weeks|IPSS storage (irritative) subscore was the sum of Component Questions 2, 4 and 7 of the IPSS questionnaire. Scores ranged from 0 (no irritative symptoms) to 5 (frequent irritative symptoms); therefore, the 3 questions of the irritative subscore ranged from 0 to 15. Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.|Baseline, 12 weeks|The analysis population included all participants who were randomized, started study medication, and had non-missing data at baseline and at least 1 post-baseline measurement.||units on a scale||Standard Error|Least Squares Mean
801263|NCT00970632|Secondary|Change From Baseline in Total International Prostate Symptom Score (IPSS) at 4 Weeks|The IPSS Total Score was obtained by combining the scores of the responses to Component Questions 1-7. Each question was scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represented greater severity of symptoms. Least Squares (LS) Mean of change from baseline to endpoint (Week 4 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.|Baseline, 4 weeks|The analysis population included all participants who were randomized, started study medication, and had non-missing data at baseline and at least 1 post-baseline measurement.||units on a scale||Standard Error|Least Squares Mean
801264|NCT00970632|Primary|Change From Baseline in Total International Prostate Symptom Score (IPSS) at 12 Weeks|The IPSS Total Score was obtained by combining the scores of the responses to Component Questions 1-7. Each question was scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represented greater severity of symptoms. Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.|Baseline, 12 weeks|The analysis population included all participants who were randomized, started study medication, and had non-missing data at baseline and at least 1 post-baseline measurement.||units on a scale||Standard Error|Least Squares Mean
801265|NCT00970684|Secondary|Best Response|The number of patients with a response will be assessed using the RECIST criteria of complete response (the disappearance of all target lesions); partial response (at least a 30% decrease in the diameter of lesions); progressive disease at least a 20% increase in the diameter of lesions); or stable disease(neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease)|1 year|One patient was unevaluable for response due to missing baseline tumor measurement.||participants|||Number
801266|NCT00970684|Secondary|Median Time to Progression|Time to progression (TTP) is defined as the time from start of treatment to first evidence of disease progression, defined per the RECIST 1.1 criteria as at least a 20% increase in the diameter of a lesion and an absolute increase of at least 5mm.|1 year|Intent to treat||months||95% Confidence Interval|Median
801267|NCT00970684|Primary|Progression Free Survival(PFS)|PFS is defined as time to death or first occurrence of documented disease progression assessed by the investigator as per the RECIST guidelines (at lease a 20% increase in the diameter of a lesion, in addition to an absolute increase of 5mm). If no deaths occur prior to progression, this measure will be the same as the median time to progression.|1 year|Intent to treat||months||95% Confidence Interval|Median
801268|NCT00970736|Secondary|Area of Submental Representation|Cortical sites are stimulated sequentially from the SOLMT in the anterior direction. At each site, 5 pulses of 110% of the MEP threshold obtained at the SOLMT are delivered and recorded. If a site produces no MEP in 3/5 pulses it is considered non-submental. This process is continued until the entire submental representation is surrounded by non-submental responsive sites. The number of sites is used to calculate the area of submental representation.|2 weeks|This data was not analyzed because the study, funding, and PIs VA affiliation ended prior to any data analyses.|||||
801269|NCT00970736|Secondary|Motor Map Center of Gravity|Position on the TMS motor map with highest amplitude response to stimulation in the muscles of interest (submental muscles).|2 weeks|This data was not analyzed because the study and funding, as well as the PIs VA affiliation, ended prior to doing any analyses.|||||
801270|NCT00970736|Primary|Mean Motor Evoked Potential Amplitude for Submental Cortical Representation|Cortical sites are stimulated sequentially from the SOLMT in the anterior direction. At each site, 5 pulses of 110% of the MEP threshold obtained at the SOLMT are delivered and recorded. If a site produces no MEP in 3/5 pulses it is considered non-submental. This process is continued until the entire submental representation is surrounded by non-submental responsive sites. The number of sites is used to calculate the area of submental representation. The mean sEMG amplitudes of the submental muscles for each of these sites is then calculated for the mean MEP measure.|2 weeks|This data was not analyzed because the study funding, as well as PIs VA affiliation, ended prior to any data analyses.|||||
801271|NCT00970814|Primary|The Percentage of Heavy Drinking Days Per Week During Study Weeks 5 Through 14.|A heavy drinking day is 5+ drinks per day for men and 4+ drinks per day for women based on self report.|Study Weeks 5-14|||percentage of heavy drinking days||Standard Error|Least Squares Mean
801272|NCT00970814|Secondary|The Number of Drinks Per Drinking Day Study Weeks 5-14.|based on self report|Study Weeks 5-14|||drinks per day||Standard Error|Least Squares Mean
801273|NCT00970814|Primary|The Percentage of Subjects With no Heavy Drinking Days During Study Weeks 5 Through 14.|A heavy drinking day is 5+ drinks per day for men and 4+ drinks per day for women based on self report.|Weeks 5-14|||percentage of subjects|||Number
801274|NCT00970853|Secondary|Teacher Rating Form (TRF), Total Problems|"The TRF is the companion to the CBCL and is completed by the child's teacher. The TRF measures a broad range of behavioral, emotional, and social functioning. The TRF asks teachers to rate problem behaviors and questions about receipt of educational services. Respondents are asked to rate 112 problem items as 0 for not true of the child, 1 for somewhat or sometimes true of the child, and 2 for very true or often true of the child, based on the past two months. The raw scores from the 112 items are then compared with age- and gender-matched controls from the standardization sample, and standard scores are derived with a mean of 50 and a standard deviation of 10. Best score is 30; worst score is 80."|8 years from study entry|||units on a scale||Standard Deviation|Mean
801275|NCT00970853|Secondary|Teacher Rating Form (TRF), Externalizing|"The TRF is the companion to the CBCL and is completed by the child's teacher. The TRF measures a broad range of behavioral, emotional, and social functioning. The TRF asks teachers to rate problem behaviors and questions about receipt of educational services. Respondents are asked to rate 112 problem items as 0 for not true of the child, 1 for somewhat or sometimes true of the child, and 2 for very true or often true of the child, based on the past two months. The raw scores from the 112 items are then compared with age- and gender-matched controls from the standardization sample, and standard scores are derived with a mean of 50 and a standard deviation of 10. Best score is 30; worst score is 80."|8 years from study entry|||units on a scale||Standard Deviation|Mean
801276|NCT00970853|Secondary|Teacher Rating Form (TRF), Internalizing|The TRF is the companion to the CBCL and is completed by the child’s teacher. The TRF measures a broad range of behavioral, emotional, and social functioning. The TRF asks teachers to rate problem behaviors and questions about receipt of educational services. Respondents are asked to rate 112 problem items as 0 for “not true of the child,” 1 for “somewhat or sometimes true of the child,” and 2 for “very true or often true of the child”, based on the past two months. The raw scores from the 112 items are then compared with scores from age- and gender-matched controls from the standardization sample, and standard scores are derived with a mean of 50 and a standard deviation of 10. value is 80; best value is 30.|8 years from study entry|||units on a scale||Standard Deviation|Mean
801277|NCT00970853|Secondary|Child Behavior Checklist (CBCL),Total Problems|"The CBCL is part of The Achenbach System of Empirically Based Assessment (ASEBA)that measures a broad range of behavioral, emotional, and social behaviors. The CBCL is administered in interview format and respondents are asked to rate 112 problem items as 0 for not true of the child, 1 for somewhat or sometimes true of the child, and 2 for very true or often true of the child, based on the past two months. The raw scores from the 112 items are then compared with age- and gender-matched controls from the standardization sample, and standard scores are derived with a mean of 50 and a standard deviation of 10. Worst score is 80; best score is 30."|8 years from study entry|||units on a scale||Standard Deviation|Mean
801278|NCT00970853|Secondary|Child Behavior Checklist (CBCL), Externalizing|"The CBCL is part of The Achenbach System of Empirically Based Assessment (ASEBA)that measures a broad range of behavioral, emotional, and social behaviors. The CBCL is administered in interview format and respondents are asked to rate 112 problem items as 0 for not true of the child, 1 for somewhat or sometimes true of the child, and 2 for very true or often true of the child, based on the past two months. The raw scores from the 112 items are then compared with age- and gender-matched controls from the standardization sample, and standard scores are derived with a mean of 50 and a standard deviation of 10. The worst possible score is 80 and the best possible score is 30."|8 years from study entry|||units on a scale||Standard Deviation|Mean
801279|NCT00970853|Secondary|Child Behavior Checklist (CBCL), Internalizing|The CBCL is part of The Achenbach System of Empirically Based Assessment (ASEBA)that measures a broad range of behavioral, emotional, and social behaviors. The CBCL is administered in interview format and respondents are asked to rate 112 problem items as 0 for “not true of the child,” 1 for “somewhat or sometimes true of the child,” and 2 for “very true or often true of the child”, based on the past two months. The raw scores from the 112 items are then compared with age- and gender-matched controls from the standardization sample, and standard scores are then derived with a mean of 50 and a standard deviation of 10. Worst value is 80; best value is 30.|8 years from study entry|||units on a scale||Standard Deviation|Mean
801280|NCT00970853|Secondary|Woodcock-Johnson Academic Ability Test, 3rd Edition (WJR-III, Ach), Broad Math|The WJR-III, Ach, Broad Math measures math academic achievement in children and offers a recent standardization sample and updated item content. The WJR-III, Ach, Math was selected because its recent standardization sample includes an appropriate proportion of children from ethnic minority, limited parent education, and Northeastern U.S. regional families. The mean test score is 100, with a standard deviation of 15. The test yields scores from 55 (worst score) to 145 (best score).|8 years from study entry|||units on a scale||Standard Deviation|Mean
801281|NCT00970853|Secondary|Woodcock-Johnson Academic Ability Test, 3rd Edition (WJR-III, Ach), Broad Reading|The WJR-III, Ach, Broad Reading measures reading achievement in children and offers a recent standardization sample and updated item content. The WJR-III, Ach, Broad Reading was selected because it includes indices of reading and a recent standardization sample that includes an appropriate proportion of children from ethnic minority, limited parent education, and Northeastern U.S. regional families.The mean test score is 100, with a standard deviation of 15. The test yields scores from 55 (worst score) to 145 (best score).|8 years from study entry|||units on a scale||Standard Deviation|Mean
801282|NCT00970853|Primary|Woodcock-Johnson Cognitive Ability Test, 3rd Edition (WJR-III, Cog)|The WJR-III, Cog measures intelligence and cognition in children and offers a recent standardization sample and updated item content. The WJR-III, Cog was selected because it includes verbal, nonverbal, and language scales and its recent standardization sample includes an appropriate proportion of children from ethnic minority, limited parent education, and Northeastern U.S. regional families.The mean test score is 100, with a standard deviation of 15. The test yields scores from 55 (worst score) to 145 (best score).|8 years post original enrollment in study|All were included.||units on a scale||Standard Deviation|Mean
801283|NCT00970944|Primary|Disability Rating Scale: Functional Status|"Measure of function after traumatic brain injury (TBI) intended to measure function from coma to community. Minimum score= 0; Maximum score= 29 (High scores are indicative of greater degree of disability)."|Randomization and weekly for 6 weeks. The primary study endpoint was week 4 and drug washout was week 6.|Analyses were conducted according to the intention-to-treat principle. 184 subjects were randomized and included for analysis. Since missing data were infrequent and unrelated to the study outcome, imputation methods were not undertaken.||units on a scale||Standard Deviation|Mean
801284|NCT00970944|Secondary|JFK Coma Recovery Scale-Revised: Neurobehavioral Status|"Measure of neurobehavioral function and clinical change for individuals with severe alterations of consciousness.
Minimum score= 0; Maximum score= 23 (Higher scores are indicative of a higher-level of neurobehavioral function)."|Week 4 (primary endpoint); Week 6 (post-washout)|Analyses were conducted according to the ITT principle so that all 184 patients randomized were included for analysis. Imputation techniques were not undertaken since missing data were infrequent and unrelated to study outcome.||units on a scale||Standard Deviation|Mean
801428|NCT00972543|Secondary|Arterial Blood Pressure||Measure at Day 0, Day 7, Week 8, Week 16 and Follow Up and Early Termination visits|Results not analysed due to early termination of the study|||||
801289|NCT00971204|Primary|Freedom From Recurrence of Atrial Fibrillation|Absence of symptomatic atrial fibrillation lasting one minute or more beyond the 90-day blanking period during the 12 month evaluation period.|12 months|Primary Effectiveness Endpoint participants. Of the 86 enrolled and treated participants, 84 were evaluable for the effectiveness endpoint.||successful participants|||Number
801290|NCT00971243|Secondary|Adverse Events, Laboratory Tests, Vital Signs, Etc.||Weeks 24, 52||||||
801291|NCT00971243|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24|Change in FPG from baseline to Week 24 or LOCF was assessed with an ANCOVA approach similar to that of the primary efficacy endpoint.|Baseline and Week 24|LOCF was implemented in the ITT population analysis to replace missing values for all those subjects who did not present a FPG value at Week 24.||mg/dL||Standard Error|Least Squares Mean
801292|NCT00971243|Primary|Change in HbA1c From Baseline to Week 24|The change of HbA1c from baseline to Week 24 or a last observation carried forward (LOCF), was assessed with an analysis of covariance (ANCOVA) model, with the centre and treatment effect as factors and the baseline HbA1c as a covariate.|Baseline and Week 24|LOCF was implemented in the Intention-to-Treat (ITT) population analysis to replace missing values for all those subjects who did not present an HbA1c value at Week 24.||percentage of HbA1c||Standard Error|Least Squares Mean
801293|NCT00971282|Primary|Pruritus|score from 0 (none) to 3 (severe)|at 4 weeks|safety population (APT)||units on a scale||Standard Error|Mean
801294|NCT00971282|Primary|Stinging/Burning|score from 0 (none) to 3 (severe)|at 4 weeks|safety population (APT)||units on a scale||Standard Error|Mean
801295|NCT00971282|Primary|Dryness|score from 0 (none) to 3 (severe)|at 4 weeks|safety population (APT)||units on a scale||Standard Error|Mean
801296|NCT00971282|Primary|Scaling|score from 0 (none) to 3 (severe)|at 4 weeks|safety population (APT)||units on a scale||Standard Error|Mean
801297|NCT00971282|Primary|Erythema Rating Scale|score from 0 (none) to 3 (severe)|at 4 weeks|safety population (APT)||units on a scale||Standard Error|Mean
801298|NCT00971295|Secondary|AUC0-∞ - Area Under the Plasma Concentration From Time Zero to Infinity|area under the plasma metformin concentration from time zero to infinity|3 weeks|||ng*h/mL||Standard Deviation|Mean
801299|NCT00971295|Secondary|Tmax - Time of Occurrence of Cmax|time of occurrence of maximum observed plasma metformin concentration|3 weeks|||hours||Standard Deviation|Mean
801300|NCT00971295|Primary|Cmax - Maximum Observed Plasma Concentration|Maximum Observed Plasma Metformin Concentration|3 weeks|||ng/mL||Standard Deviation|Mean
801301|NCT00971425|Secondary|Number of Subjects With AEs of Specific Interest|Adverse events of specific interest included auto-immune diseases and other immune mediated disorders.|During the entire study period (Day 0-364)|The analysis was performed on the Total Vaccinated cohort.||subjects|||Number
801302|NCT00971425|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the entire study period (Day 0-364)|The analysis was performed on the Total Vaccinated cohort.||subjects|||Number
801303|NCT00971425|Primary|Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain|"The Pandemrix vaccine strain was A/Cal/7/09.
A seroprotected subject was defined as a subject with a serum HI antibody titer greater than or equal to 1:40."|At Day 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available.||subjects|||Number
801304|NCT00971425|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|"Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Any: any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3: unsolicited AE that prevented normal everyday activity Related: unsolicited AE assessed by the investigator as related to the vaccination"|During 21 days (Day 0-20) after each vaccination|The analysis was performed on the Total Vaccinated cohort.||subjects|||Number
801305|NCT00971425|Primary|Seroconversion Factor for Antibodies Against Pandemrix Vaccine Strain|"Seroconversion Factor (SCF) is defined as the fold increase in serum HI antibody GMTs post-vaccination compared to prevaccination (Day 0).
The Pandemrix vaccine strain was A/Cal/7/09."|At Day 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available.||fold increase||95% Confidence Interval|Mean
801306|NCT00971425|Primary|Number of Seroconverted Subjects for Antibodies Against Pandemrix Vaccine Strain|"The Pandemrix vaccine strain was A/Cal/7/09.
A subject seroconverted for haemagglutination inhibition (HI) antibodies was defined as a subject with either a prevaccination (Day 0) HI antibody titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a prevaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer."|At Day 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available.||subjects|||Number
801307|NCT00971425|Primary|Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain|"The Pandemrix vaccine strain was A/Cal/7/09.
The cut-off was a titer of 1:10 and this titer was considered as seropositivity."|At Day 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available.||subjects|||Number
801308|NCT00971425|Secondary|Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix|Solicited local symptoms were pain, redness and swelling at the injection site. General symptoms were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating, temperature (defined as axillary temperature equal to or above 37.5 degrees Celsius)|During a 7-Day (Day 0-6) follow-up period after each administration of (at Day -21 and at Day 42) placebo or Fluarix|The analysis was performed on the Total Vaccinated cohort on subjects with available results.||subjects|||Number
801350|NCT00971997|Secondary|Change From Baseline in Fasting C-Peptide at Week 48 to Endpoint|C-peptide is a protein that is produced in the body along with insulin.|Baseline, Week 48|Participants received at least one dose of the study drug, and had both baseline and post-baseline values.||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
801309|NCT00971425|Secondary|Number of Subjects With Solicited Local and General Symptoms After Administration of Pandemrix|Solicited local symptoms were pain, redness and swelling at the injection site. Solicited general symptoms were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating, temperature (defined as axillary temperature equal to or above 37.5 degrees Celsius).|During a 7-Day (Day 0-6) follow-up period after each administration of Pandemrix|The analysis was performed on the Total Vaccinated cohort on subjects with available results||subjects|||Number
801310|NCT00971425|Secondary|Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains|"A seroprotected subject was defined as a subject with a serum HI antibody titer greater than or equal to 1:40.
Pandemrix vaccine strain (A/Cal/7/09) data were assessed up to Month 12. Note that Day 42 data for Pandemrix vaccine strain were already addressed as a primary outcome measure.
Fluarix vaccine strains (A/Bri/59/07, B/Bri/60/08, and A/Uru/716/07) data were only assessed up to Day 63."|Day -21, Day 0, Day 21, Day 42, Day 63, Month 6 and Month 12|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available.||subjects|||Number
801311|NCT00971425|Secondary|Seroconversion Factor for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains|"For the definition of seroconversion factor, please refer to the primary outcome measure.
Pandemrix vaccine strain (A/Cal/7/09) data were generated for Day 21, Month 6 and Month 12.
Fluarix vaccine strains (A/Bri/59/07, B/Bri/60/08, and A/Uru/716/07) data were generated at 21 days after Fluarix administration, i.e. depending on the group at Day 0 or Day 63 (Day 0/Day 63)."|At Day 21, Month 6 and Month 12 for Pandemrix vaccine strain, and at Day 0/Day 63 for Fluarix vaccine strains.|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available.||fold increase||95% Confidence Interval|Mean
801312|NCT00971425|Secondary|Number of Seroconverted Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains|"A seroconverted subject was defined as a subject with either a prevaccination (Day 0) HI antibody titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a prevaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer.
Pandemrix vaccine strain (A/Cal/7/09) data were generated for Day 21, Month 6 and Month 12.
Fluarix vaccine strains (A/Bri/59/07, B/Bri/60/08, and A/Uru/716/07) data were generated at 21 days after Fluarix administration, i.e. depending on the group at Day 0 or Day 63 (Day 0/Day 63)."|At Day 21, Month 6 and Month 12 for Pandemrix vaccine strain, and at Day 0/Day 63 for Fluarix vaccine strains.|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available.||subjects|||Number
801313|NCT00971425|Secondary|Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains|"The cut-off was a titer of 1:10 and this titer was considered as seropositivity.
Pandemrix vaccine strain (A/Cal/7/09) data were assessed up to Month 12. Note that Day 42 data for Pandemrix vaccine strain were already addressed as a primary outcome measure.
Fluarix vaccine strains (A/Bri/59/07, B/Bri/60/08, and A/Uru/716/07) data were only assessed up to Day 63."|At Day -21, Day 0, Day 21, Day 42, Day 63, Month 6 and Month 12|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available.||subjects|||Number
801314|NCT00971425|Secondary|Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains|"Pandemrix vaccine strain (A/Cal/7/09) data were assessed up to Month 12. Note that Day 42 data for Pandemrix vaccine strain were already addressed as a primary outcome measure.
Fluarix vaccine strains (A/Bri/59/07, B/Bri/60/08, and A/Uru/716/07) data were only assessed up to Day 63."|Day -21, Day 0, Day 21, Day 42, Day 63, Month 6 and Month 12|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available.||titer||95% Confidence Interval|Geometric Mean
801315|NCT00971425|Primary|Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain|"Titers were expressed as GMTs.
The Pandemrix vaccine strain was A/Cal/7/09."|At Day 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available.||titer||95% Confidence Interval|Geometric Mean
801316|NCT00971620|Secondary|Worst Pain Severity|Pain severity was assessed by the Brief Pain Inventory (BPI). The BPI is a validated pain assessment tool that assesses severity of pain, location of pain, impact of pain on daily functions, pain medications, and amount of pain relief in the past 24 hours or past week (e.g. scale of 0-10 (worst pain)). This outcome was based on a single 0-10 question on the BPI.|Week 0 vs. week 4|||Score||Full Range|Median
801317|NCT00971620|Secondary|Percentage of Patients With a Change in Post-Ice Visual Analog Score (VAS) Between Week 0 and Week 4|The VAS is a commonly used validated tool for assessment of pain. The 10-cm VAS was used to assess current patient pain/discomfort before and after application of ice to study lesions. A clinically meaningful change in chronic pain intensity using the VAS has been determined as a reduction of 2 points or 30%. Scale is 0-10. 10 = worse pain.|Week 0 vs. week 4|||percentage of patients|||Number
801318|NCT00971620|Secondary|Percentage of Patients With a Change in Pre-Ice Visual Analog Score (VAS) Between Week 0 and Week 4|The VAS is a commonly used validated tool for assessment of pain. The 10-cm VAS was used to assess current patient pain/discomfort before and after application of ice to study lesions. A clinically meaningful change in chronic pain intensity using the VAS has been determined as a reduction of 2 points or 30%. Scale of 0-10. 10 = worse pain.|Week 0 vs. week 4|||percentage of patients|||Number
801319|NCT00971620|Secondary|Percentage of Patients With a Change in Average Pain Score|Average pain was determined from a 0-10 scale question on the Brief Pain Inventory (BPI). 10 denotes worse pain.|Week 0 score vs. week 4 score|||percentage of patients|||Number
801320|NCT00971620|Secondary|Immunohistochemical Staining of Cutaneous Leiomyomas for C-fos Before (i.e., Week 0) and 12 Weeks After Botulinum Toxin Administration|c-fos, a marker of neuronal activation after pain stimulation, was scored as 0 (none), 1 (scattered), 2 (<66% of tumor cells), or 3 (≥66% of tumor cells).|Week 0 vs. week 12|||Score||Full Range|Median
801321|NCT00971620|Secondary|Immunohistochemical Staining of Cutaneous Leiomyomas for Acetylcholinesterase (AchE) Before (i.e.,Week 0) and 12 Weeks After Botulinum Toxin Administration|AchE staining was scored as 0 (none), 1 (rare), 2 (scattered), or 3 (focal or greater).|Week 0 vs. week 12|||Score||Full Range|Median
801322|NCT00971620|Secondary|Change in Post-Ice Provocation Visual Analog Score (VAS) Between Week 12 and Week 24|The VAS is a commonly used validated tool for assessment of pain. The 10-cm VAS was used to assess current patient pain/discomfort before and after application of ice to study lesions. A clinically meaningful change in chronic pain intensity using the VAS has been determined as a reduction of 2 points or 30%. Scale is 0-10. 10 denotes worse pain than 0.|Between week 12 and 24|||Score||Full Range|Median
801323|NCT00971620|Secondary|Specific Skin Pain-Related Question on the Dermatology Life Quality Index|"The DLQI is a 10-question quality of life survey which has been extensively validated and frequently used in dermatologic disorders such as atopic dermatitis, acne, and psoriasis. Participants response to the question Over the last week, how itchy, sore, painful or stinging has your skin been? was assessed by the Dermatology Life Quality Index. This outcome refers to a single specific question on the DLQI, so the range for this outcome is 0-3. Lower values in the DLQI indicate less impairment (or greater improvement) in life quality from the skin disease."|Week 0 vs. week 4|||Units on a scale||Full Range|Median
801324|NCT00971620|Secondary|Comparison of Change in Skin Related Quality of Life by Total Dermatology Life Quality Index (DLQI) at Week 0 vs. Week 4|The DLQI is a 10-question quality of life survey which has been extensively validated and frequently used in dermatologic disorders such as atopic dermatitis, acne, and psoriasis. Score is 0-30 based on 10 questions. The higher the score, the more quality of life is impaired.|Week 0 vs. week 4|||Units on a scale||Full Range|Median
801325|NCT00971620|Secondary|Visual Analog Scale (VAS) of Patient Perceived Pain at Leiomyoma Site Prior to Ice Provocation at Week 0 vs. Week 4|The VAS is a commonly used validated tool for assessment of pain. For this measure, a 10-cm VAS was used to assess current patient pain/discomfort before application of ice to study lesions at week 0 and week 4. A clinically meaningful change in chronic pain intensity using the VAS has been determined as a reduction of 2 points or 30%. Range is 0-10; 0 is no pain and 10 is worst possible pain.|Week 0 vs. week 4|||Score||Full Range|Median
801326|NCT00971620|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|37 months|||participants|||Number
801327|NCT00971620|Primary|Median Change in Average Pain Between Two Arms|Change in average pain was assessed by the Brief Pain Inventory (BPI). The BPI is a validated pain assessment tool that assesses severity of pain, location of pain, impact of pain on daily functions, pain medications, and amount of pain relief in the past 24 hours or past week (e.g. scale of 0-10 (worst pain)).|Between weeks 0 and week 4|||Score||Full Range|Median
801328|NCT00971620|Primary|Change in Worst Lesional Pain in the Past Week Based on Brief Pain Inventory|Change in worst lesional pain in the past week based on Brief Pain Inventory (BPI) from Week 0 to Week 4 in treated patients versus controls. The BPI uses an arbitrary units on a 0-10 scale. For the purposes of the statistical calculation, a difference of 1 standard deviation between groups at baseline vs. week 4 was considered significant. Any BPI value above zero (no pain) is abnormal. The mean change indicates mean change in pain score.|Between week 0 and week 4|||units on a scale||Standard Error|Mean
801329|NCT00971633|Primary|Maximum Plasma Concentration (Cmax) of Ondansetron||24 hours post dose|All study participants (N=12)||nM||Standard Deviation|Least Squares Mean
801330|NCT00971633|Primary|Area Under the Plasma Concentration-Time Curve From Zero to Infinity (AUC) of Ondansetron||0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, and 24 hours post dose|All study participants (N=12)||nM*hr||Standard Deviation|Least Squares Mean
801331|NCT00971750|Primary|Polyps on Transabdominal and Laparoscopic Ultrasound|Number of patients with polyps.|6 years|||participants|||Number
801332|NCT00971750|Secondary|Common Bile Duct (CBD) Diameter Measured by Transabdominal Ultrasound Versus Laparoscopic Ultrasound.|Mean CBD diameter.|transabdominal measurements will be done within 30 days prior to surgery; laparoscopic ultrasound measurements are completed intraoperatively|||millimeters||Standard Deviation|Mean
801333|NCT00971750|Primary|Cholelithiasis on Transabdominal Ultrasound Versus Laparoscopic Ultrasound.|Number of patients with cholelithiasis.|transabdominal measurements within 30 days prior to surgery; laparoscopic ultrasound measurements are completed intraoperatively|||participants|||Number
801334|NCT00971789|Primary|Number of Participants With Adverse Events|Here is the number of participants with adverse events|47 months|||Participants|||Number
801335|NCT00971789|Primary|Biochemical Changes in Benign and Malignant Tumor Tissues as Assessed by Immunohistochemistry.|A biochemical change is defined as a decrease in certain protein levels (e.g. P-AKT (phosphorylated AKT), total S6, P-S6, and P-4E-BP1) important in cell growth. These are measured by collecting tissue samples which stained and protein levels are measured under the microscope. Scoring will be based on distribution and intensity of staining. Distribution will be scored as 0 (0%), 1 (1% to 50%), and 2 (51% to 100%) to indicate the percentage of positive cells of interest in a single core. The intensity of the signal will be scored as 1 (weak), 2 (moderate), and 3 (strong). The distribution score and intensity score will be summed into a total score (TS).|Baseline, day 14, and day 56|No patient underwent biopsy after the study treatment, so no such tissue analysis was done.|||||
801336|NCT00971841|Secondary|Number of Participants With Complete Response to Tumor|Tumor measured/evaluated via imaging and assessed according to the Response Evaluation Criteria in Solid Tumor (RECIST) version 1.0 wherein complete response is disappearance of all target lesions; partial response is 30% decrease in the sum of the longest diameter of target lesions; progressive disease is 20% increase in the sum of the longest diameter of target lesions, and stable disease is small changes that do not meet above criteria. The baseline assessment was done prior to the first administration of drug in the original Study CA139-540 (NCT 00344552).|Every 7 weeks Day 1 to 4 years|Only one participant enrolled so results are for one participant.||participants|||Number
801337|NCT00971841|Primary|Number of Adverse Events (AEs) Per Participant|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Severity of the adverse event was judged and graded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 2.0.|Weekly Day 1 to 4 years|Only one participant enrolled in the study so all results represent one participant.||adverse events|||Number
801419|NCT00972543|Secondary|Haematology Laboratory Assessments - Lymphocytes|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits|||participants|||Number
801338|NCT00971932|Secondary|Time to Treatment Failure|Time to treatment failure according to modified WHO criteria as assessed by IRC was defined as the time from first administration of trial treatment until the date of the first occurrence of one of the events defining treatment failure: PD assessed by the investigator, discontinuation of treatment due to PD, discontinuation of treatment due to an adverse event (AE), start of any new anticancer therapy, or withdrawal of consent or death within 60 days of the last tumor assessment or first administration of trial treatment.|Time from first administration of trial treatment to treatment failure or last tumor assessment, reported between day of first participant treated, until cut-off date, 02 March 2011|"ITT population included all participants who received at least one dose of the study medication. Here number of participants analyzed N is signifying those participants for whom trial treatment failed."||months||95% Confidence Interval|Median
801339|NCT00971932|Secondary|Overall Survival (OS) Time|Time from first administration of trial treatment to death. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.|Time from first administration of trial treatment or last day known to be alive, reported between day of first participant treated, until cut-off date, 02 March 2011|ITT population included all participants who received at least one dose of the study medication.||months||95% Confidence Interval|Median
801340|NCT00971932|Secondary|Progression-Free Survival (PFS) Time|The PFS time according to modified WHO criteria as assessed by IRC was defined as duration from first administration of trial treatment until PD (radiological or clinical, if radiological progression is not available) or death due to any cause. Only deaths within 60 days of last tumor assessment are considered. Participants without event are censored on the date of last tumor assessment.|Time from first administration of trial treatment to PD, death or last tumor assessment, reported between day of first participant treated, until cut-off date, 02 March 2011|ITT population included all participants who received at least one dose of the study medication.||months||95% Confidence Interval|Median
801341|NCT00971932|Secondary|Duration of Response|Duration of response according to modified WHO criteria as assessed by IRC was defined as the time from the first assessment of CR or PR until the date of the first occurrence of PD, or until the date of death when death occurred within 60 days of the last tumor assessment or first administration of trial treatment (whichever was last).|Time from first assessment of CR or PR to PD, death or last tumor assessment, reported between day of first participant treated, until cut-off date, 02 March 2011|Subgroup of participants from the study population with a best overall response (CR or PR).||months||95% Confidence Interval|Median
801342|NCT00971932|Secondary|Disease Control Rate|Percentage of participants experiencing a CR (complete disappearance of measurable and evaluable disease without new lesions) or PR (>=50 percent decrease in sum of the products of diameters [SOPD] of index lesions compared to baseline SOPD, with no evidence of PD) confirmed by subsequent assessment no less than 28 days after criteria for response were first met) or stable disease [SD] (neither sufficient decrease to qualify for PR nor sufficient increase to qualify for PD) at least once no less than 42 days after first dose of trial treatment based on modified WHO criteria as assessed by IRC.|Evaluations performed every 6 weeks until PD reported between day of first participant treated, until cut-off date, 02 March 2011|ITT population included all participants who received at least one dose of the study medication.||percentage of participants||95% Confidence Interval|Number
801343|NCT00971932|Secondary|Best Overall Response (BOR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Criteria|Percentage of participants with objective response based assessment of confirmed CR or confirmed PR according to RECIST as assessed by IRC. CR are those that persist on repeat imaging study at least 28 days after initial documentation of response. PR are those with greater than or equal to 30 percent decrease in the SOPD of index lesions compared to the baseline SOPD, with no evidence of PD.|Evaluations performed every 6 weeks until PD reported between day of first participant treated, until cut-off date, 02 March 2011|ITT population included all participants who received at least one dose of the study medication.||percentage of participants||95% Confidence Interval|Number
801344|NCT00971932|Primary|Best Overall Response (BOR) According to Modified World Health Organization (WHO) Criteria|Percentage of participants experiencing a complete response [CR] (complete disappearance of measurable and evaluable disease without new lesions) or partial response [PR] (greater than or equal to 50 percent decrease in the sum of the products of diameters [SOPD] of index lesions compared to the baseline SOPD, with no evidence of PD) confirmed by a subsequent assessment no less than 28 days after criteria for response were first met based on modified WHO criteria as assessed by Independent Review Committee (IRC).|Evaluations performed every 6 weeks until progressive disease (PD) reported between day of first participant treated, until cut-off date, 02 March 2011|Intention-to-treat (ITT) population included all participants who received at least one dose of the study medication.||percentage of participants||95% Confidence Interval|Number
801345|NCT00971997|Secondary|Number of Hypoglycemia Episodes Participants Experienced at Any Time From Baseline Through Week 48|A hypoglycemic episode was considered any hypoglycemic event in which participants themselves recognized hypoglycemia-related signs and symptoms, or participants had a blood glucose level below 50 mg/dL regardless of signs, symptoms or the relationship to treatment.|Baseline through Week 48|Participants received at least one dose of the study drug.||number of hypoglycemic episodes|||Number
801346|NCT00971997|Secondary|Percentage of Participants Developing Hypoglycemia at Any Time From Baseline Through Week 48|Results are reported as the percentage of participants experiencing hypoglycemia, which was considered any hypoglycemic event in which participants themselves recognized hypoglycemia-related signs and symptoms, or they had a blood glucose level below 50 milligram/deciliter (mg/dL) regardless of signs, symptoms or the relationship to treatment.|Baseline through Week 48|Participants received at least one dose of the study drug.||percentage of participants|||Number
801347|NCT00971997|Secondary|Total Daily Dose of Insulin at Baseline, Week 16, Week 32 and Week 48||Baseline and Weeks 16, 32 and 48|Participants who completed treatment through Week 48.||units of insulin/day||Standard Deviation|Mean
801348|NCT00971997|Secondary|Change From Baseline in Body Weight at Week 48 Endpoint||Baseline, Week 48|Participants who completed treatment through Week 48, and had both baseline and post-baseline value.||kilogram (kg)||Standard Deviation|Mean
801349|NCT00971997|Secondary|Change From Baseline in Fasting Serum Lipids at Week 48 Endpoint||Baseline, Week 48|Participants received at least one dose of the study drug, and had both baseline and post-baseline values.||mg/dL||Standard Deviation|Mean
801351|NCT00971997|Secondary|Change From Baseline in Blood Glucose Profile at Week 48 Endpoint|Time course of changes in blood glucose was determined by 7-point self-monitoring of blood glucose (SMBG) during the day (before breakfast, lunch, and dinner, 2 hours after the start of each meal, and at bedtime).|Baseline, Week 48|Participants received at least one dose of the study drug, and had both baseline and post-baseline values.||mg/dL||Standard Deviation|Mean
801352|NCT00971997|Secondary|Change From Baseline in Fasting Glucose at Week 48 Endpoint||Baseline, Week 48|Participants received at least one dose of the study drug, and had both baseline and post-baseline values.||milligram/deciliter (mg/dL)||Standard Deviation|Mean
801353|NCT00971997|Secondary|Change From Baseline in Hemoglobin A1c (HbA1c) at Week 48 Endpoint|Hemoglobin A1c (HbA1c) is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time.|Baseline, Week 48|Participants received at least one dose of the study drug, and had both baseline and post-baseline values.||percentage of glycosylated hemoglobin||Standard Deviation|Mean
801354|NCT00971997|Secondary|Percentage of Participants Achieving Hemoglobin A1c (HbA1c) Level Below 6.5% and Below 7.0% by Regimen at Week 48 Endpoint|Hemoglobin A1c (HbA1c) is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. 6.5% and 7.0% HbA1c are the Japan Diabetes Society (JDS) values, and are equivalent to the National Glycohemoglobin Standardization Program (NGSP) HbA1c values of 6.9% and 7.4%, respectively.|Week 48|Participants completed treatment through Week 48.||percentage of participants||95% Confidence Interval|Number
801355|NCT00971997|Secondary|Percentage of Participants Achieving Hemoglobin A1c (HbA1c) Below 7.0% at Week 16, 32 and 48 Endpoints|Hemoglobin A1c (HbA1c) is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The 7.0% HbA1c is the Japan Diabetes Society (JDS) value, and is equivalent to the National Glycohemoglobin Standardization Program (NGSP) HbA1c value of 7.4%.|Week 16 and Week 32 and Week 48|Participants received at least one dose of the study drug.||percentage of participants||95% Confidence Interval|Number
801356|NCT00971997|Secondary|Percentage of Participants Achieving Hemoglobin A1c (HbA1c) Below 6.5% at Week 16 and Week 32 Endpoints|Hemoglobin A1c (HbA1c) is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The 6.5% HbA1c is the Japan Diabetes Society (JDS) value, and is equivalent to the National Glycohemoglobin Standardization Program (NGSP) HbA1c value of 6.9%.|Week 16 and Week 32|Participants received at least one dose of the study drug.||percentage of participants||95% Confidence Interval|Number
801357|NCT00971997|Primary|Percentage of Participants Achieving Hemoglobin A1c (HbA1c) Below 6.5% at Week 48 Endpoint|Hemoglobin A1c (HbA1c) is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The 6.5% HbA1c is the Japan Diabetes Society (JDS) value, and is equivalent to the National Glycohemoglobin Standardization Program (NGSP) HbA1c value of 6.9%.|Week 48|Participants received at least one dose of the study drug.||percentage of participants||95% Confidence Interval|Number
801358|NCT00972023|Secondary|Toxicity||Within 48 hours prior to surgery and after 14 days of DHEA treatment.|Per protocol, although no analysis was completed, patient chose to receive neoadjuvant chemo instead of surgery & refused follow up.|||||
801359|NCT00972023|Secondary|Effect of DHEA on Changes in Serum Estrogen and Androgen Hormone Levels (e.g., Estrone, Estradiol, Testosterone, Dihydrotestosterone, DHEA, and DHEA-sulfate)||Baseline, prior to DHEA treatment, within 48 hours prior to surgery and after 14 days of DHEA treatment.|Per protocol, although no analysis was completed, patient chose to receive neoadjuvant chemo instead of surgery & refused follow up.|||||
801360|NCT00972023|Secondary|Effect of Dehydroepiandrosterone (DHEA) on Androgen Receptor Expression||Baseline, prior to DHEA treatment, within 48 hours prior to surgery and after 14 days of DHEA treatment.|Per protocol, although no analysis was completed, patient chose to receive neoadjuvant chemo instead of surgery & refused follow up.|||||
801361|NCT00972023|Primary|Tumor Proliferation (Percentage of Ki-67 Positive Cells)||Baseline, prior to DHEA treatment, within 48 hours prior to surgery and after 14 days of DHEA treatment.|Per protocol, although no analysis was completed, patient chose to receive neoadjuvant chemo instead of surgery & refused follow up.|||||
801362|NCT00972088|Primary|Prevalence of Inflammation as Diagnosed by Capsule Endoscopy|The capsule endoscopy findings were carefully examined by specialists in the field. findings such as erosions, edema, erythema and ulceration in significant areas of the intestine led to the clinical diagnosis of crohn's disease. all together 6 patients were diagnosed as suffering from crohn's disease.|up to 7 days|per protocol||participants|||Number
801363|NCT00972153|Secondary|Surgery Site Particulate Density (Size >10 Micrometer)Per Cubic Meter|Airborne particulate was measured using a particle analyzer (LASAIR II 310B). The analyzer sampled continuously during surgery at a rate of 28.3 L/min and recorded data at one-minute intervals. The samples were collected through a length of sterile PVC tubing with the end placed adjacent to the CFU sample tubing, within 5 cm of the surgical incision. Particles of various diameters were obtained; particles of size >10 micrometer had the strongest correlation to the presence of CFUs at the incision site.|Ten minute intervals throughout surgery|||>10 micrometer particles / cubic meter||Full Range|Median
801364|NCT00972153|Primary|Surgery Site CFU Density|"Colony forming unit counts were collected from the air within 5 cm of the surgical wound using a bioaerosol slit sampling device. Air was drawn through a sterile PVC tubing located at the incision and impacted upon media (TSA 5% sheep's blood) plates located in the sampling device. The plates were exchanged every 10 minutes throughout the procedure. Values are presented as CFU/cubic meter."|Ten minute intervals throughout surgery|Airborne CFU densities were obtained in ten-minute intervals throughout each procedure. Average surgery duration was 69 minutes in the control and sham groups; 66 minutes in the experiment group. A total of 208 density readings were obtained.||CFU/cubic meter||Full Range|Median
801365|NCT00972205|Secondary|Number of Participants Who Had an Overall Response|"Response is determined by the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria. Complete response (CR)-disappearance of all target lesions, Partial response (PR)-at least a 30% decrease in the sum of the longest diameter(LD)of target lesions, stable disease (SD) - neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.
See the Protocol Link module for further details about the RECIST Criteria."|Baseline to progression|||participants with response|||Number
823786|NCT01175902|Primary|Intraocular Pressure (IOP), Period 2|IOP (mean IOP) after treaemt from week 8 to week 12|12 weeks|||mmHg||Standard Deviation|Mean
801366|NCT00972205|Secondary|Percent Inhibition of Rhodamine Efflux From CD56+Cells Post Treatment|Rhodamine 123 was added to whole blood obtained before and after CBT-1. The blood was incubated, layered on lymphocyte separation medium and centrifuged. Peripheral blood mononuclear cells(PBMCs)were isolated, washed and incubated in rhodamine-free medium with or without valspodar. Cells were washed and incubated in phycoerythrin-labeled anti-CD56 antibody or negative control antibody. Rhodamine 123 fluorescence was assessed in CD56+cells with or without valspodar and a 60 min efflux period,continuing the cells without or with valspodar to generate Efflux and PSC/Efflux histograms.|Rhodamine efflux was performed on blood drawn prior to CBT-1 ingestion and after 6 days of dosing.|Rhodamine 123 fluorescence was assessed in CD56+cells after a 30 min loading period with or without exogenously added valspodar and a 60 min efflux period followed, continuing the cells with or without exogenous valspodar to generate Efflux and PSC/Efflux histograms. Percent decrease in difference between these histograms is reported.||Percent inhibition of rhodamine efflux||Full Range|Mean
801367|NCT00972205|Primary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|18 months|||Participants|||Number
801368|NCT00972205|Primary|Percent Increase in Sestamibi Retention in the Liver as a Measure of P-glycoprotein Inhibition|An area under the concentration curve (AUC) was calculated for 99mTc counts over the liver, lungs, and heart. An equation was applied to determine the increase in sestamibi in the liver: [(AUCpost - AUC baseline)/(AUC baseline)] x 100.|sestamibi scanning was performed on day 0 and day 6, allowing scans to be performed pre and post CBT-1 administration|As planned imaging data from 10 pts were analyzed.||percent increase sestamibi retention||Full Range|Median
801369|NCT00972244|Secondary|Proportion of Participants Achieving Glycemic Response Defined as HbA1c <7%|Proportion of participants achieving therapeutic glycemic response defined as glycosylated hemoglobin <7%, after 12 weeks of double-blind therapy|At Week 12|Full Analysis Set, participants with non-missing baseline and week 12 (LOCF) values||Percentage of participants|||Number
801370|NCT00972244|Secondary|Adjusted Mean Change in Fasting Plasma Glucose|Change in fasting plasma glucose from baseline to Week 12 or the last post-baseline measurement prior to Week 12, if no Week 12 assessment is available.|Baseline to Week 12|Full Analysis Set, participants with non-missing baseline and Week 12 (LOCF) values||mg/dL||95% Confidence Interval|Least Squares Mean
801371|NCT00972244|Primary|Adjusted Mean Change in HbA1c Levels|The primary efficacy endpoint is the absolute change in HbA1c from baseline to Week 12 or the last post-baseline measurement prior to Week 12, if no Week 12 assessment is available.|Baseline to Week 12|Full Analysis Set, participants with non-missing baseline and Week 12 (LOCF) values||percent||95% Confidence Interval|Least Squares Mean
801372|NCT00972283|Secondary|Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.|Week 0 to Week 52 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator.||Episodes/100 years of patient exposure|||Number
801373|NCT00972283|Secondary|Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 52 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator.||Episodes/100 years of patient exposure|||Number
801374|NCT00972283|Primary|Rate of Treatment Emergent Adverse Events (AEs)|Corresponds to rate of AEs per 100 patient years of exposure. Mild AEs: no or transient symptoms, no interference with subject’s daily activities. Moderate AEs: marked symptoms, moderate interference with subject’s daily activities. Severe AEs: considerable interference with subject’s daily activities, unacceptable. Serious adverse event (SAE): AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.|Week 0 to Week 78 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator.||Events/100 years of patient exposure|||Number
801375|NCT00972283|Primary|Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.|Week 0 to Week 78 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator in the main trial including subjects carried through to the extension trial.||Episodes/100 years of patient exposure|||Number
801376|NCT00972283|Primary|Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 78 + 7 days follow up|Safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or its comparator in the main trial including subjects carried through to the extension trial.||Episodes/100 years of patient exposure|||Number
801420|NCT00972543|Secondary|Haematology Laboratory Assessments - Neutrophils|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits|||participants|||Number
801377|NCT00972283|Secondary|Extension Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 78|Mean of the SMPG at 78 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am, before breakfast.|Week 78|The FAS included all randomised subjects in the main trial including subjects carried through to the extension trial and missing data was imputed using LOCF. For 36 subjects all 9-point SMPG values were missing.||mmol/L||Standard Deviation|Mean
801378|NCT00972283|Secondary|Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 52|Mean of 9-point SMPG at 52 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast.|Week 52|The FAS included all randomised subjects and missing data was imputed using LOCF. For 36 subjects all 9-point SMPG values were missing.||mmol/L||Standard Deviation|Mean
801379|NCT00972283|Secondary|Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 78 Weeks of Treatment|Change from baseline in HbA1c after 78 weeks of treatment|Week 0, Week 78|The FAS included all randomised subjects in the main trial including subjects carried through to the extension trial and missing data was imputed using LOCF||percentage of glycosylated haemoglobin||Standard Deviation|Mean
801380|NCT00972283|Primary|Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment|Change from baseline in HbA1c after 52 weeks of treatment|Week 0, Week 52|Full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF)||percentage of glycosylated haemoglobin||Standard Deviation|Mean
801381|NCT00972322|Primary|Number of Participants Discontinuing Study Drug Due to an AE|An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to Day 28|All participants who received at least one dose of the investigational drug.||Participants|||Number
801382|NCT00972322|Primary|Number of Participants Who Experienced Serious or Non-serious Adverse Events|An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. A serious AE is any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.|Up to Day 31|All participants who received at least one dose of the investigational drug.||Participants|||Number
801383|NCT00972322|Primary|Change From Baseline in the 24-hour Weighted Mean Glucose (WMG)|"The 24-hour WMG is derived from multiple glucose values collected during both fasting and post-meal periods. A weighted rather than a simple mean is used to avoid overrepresentation of post-meal glucose values. Blood samples for glucose were collected immediately prior to, and after each meal, and overnight and fasting one hour pre-dose."|Baseline and Day 28|All participants who were compliant with the study procedures and have available data from at least one treatment were included in the primary analysis dataset.||mg/dL||Standard Deviation|Least Squares Mean
801384|NCT00972335|Secondary|To Correlate the Activity of This Treatment Regimen With Expression of Selected Intra-tumoral Biomarkers.||18 months||||||
801385|NCT00972335|Secondary|To Evaluate the Toxicity of Bevacizumab/Everolimus in Patients With Recurrent Meningioma.||18 months|Includes all treated patients (one patient not treated)||participants|||Number
801386|NCT00972335|Primary|Progression-free Survival (PFS), in the Treatment of Patients With Refractory Meningioma.|Progression-free survival (PFS) is defined as the time from randomization until objective tumor progression (PD) or death. Progression is defined per MacDonald criteria for response as ≥25% increase in size of enhancing tumor or any new tumor on MRI scan, neurologically worse, and steroids stable or increased.|18 months|Includes all enrolled and treated patients (one patient not treated)||months||95% Confidence Interval|Median
801387|NCT00972374|Other Pre-specified|Percentage of Patients With Intraocular Pressure (IOP) < 10 mmHg in the Study Eye at Any Follow up Visit|IOP is the fluid pressure inside the eye. The percentage of patients with IOP < 10 millimeters of mercury (mmHg) in the study eye at any follow up visit is presented.|12 Months|Intent to Treat: all randomized patients||Percentage of Patients|||Number
801388|NCT00972374|Secondary|Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening.|Baseline, Month 3|Intent to Treat: all randomized patients||Number of Letters Read Correctly||Standard Deviation|Mean
801389|NCT00972374|Primary|Percentage of Patients With at Least a 15-Letter Increase From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates that vision has improved. The percentage of patients with at least a 15-letter increase in BCVA in the study eye is reported.|Month 3|Intent to Treat: all randomized patients||Percentage of Patients|||Number
801421|NCT00972543|Secondary|Haematology Laboratory Assessments - Platelets|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits|||participants|||Number
801395|NCT00972504|Secondary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention or is associated with liver injury and impaired liver function defined as: alanine aminotransferase >=3 times upper limit of normal (ULN), and total bilirubin >=2 times ULN or international normalized ratio more than 1.5.|approximately up to 63 days|All Subjects population.||Participants|||Number
801396|NCT00972504|Secondary|Mean Forced Expiratory Volume in 1 Second (FEV1)|On the third dosing day, participants entered the ECC for a duration of 6 hours, 1 hour after receiving their third dose. Time 0 hour was considered as the time that the participant entered the ECC. FEV1 was measured at pre-challenge, 60, 120, 180, 240, 300 and 360 minutes.|Day 3 of each treatment period (approximately up to 63 days)|All Subjects population. Only those participants with data available at the indicated time points were analyzed (represented by n=x,x,x,x,x in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects population.||Liters||Standard Deviation|Mean
801397|NCT00972504|Secondary|Weighted Mean Nasal Congestion VAS 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3|On the third dosing day, participants entered the ECC for a duration of 6 hours, 1 hour after receiving their third dose. Time 0 hour was considered as the time that the participant entered the ECC. Nasal congestion was measured on 0-10 centimeter VAS scale (0: no symptoms and 10: the worst possible symptoms) with low score indicates well-being and higher values indicate greater congestion. It was measured at 60, 80, 100, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300, 320, 340 and 360 minutes. The adjusted mean is provided as least square mean.|Day 3 of each treatment period (approximately up to 63 days)|All Subjects population. Only those participants with data available at the indicated time points were analyzed.||Score on a scale||95% Confidence Interval|Least Squares Mean
801398|NCT00972504|Secondary|Weighted Mean Wet Tissue Weight (as a Surrogate Marker of Nasal Secretion) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3|On the third dosing day, participants entered the ECC for a duration of 6 hours, 1 hour after receiving their third dose. Time 0 hour was considered as the time that the participant entered the ECC. Wet tissue weight assessments was measured as a surrogate marker of nasal secretion at 60, 120, 180, 240, 300 and 360 minutes. The adjusted mean is provided as least square mean.|Day 3 of each treatment period (approximately up to 63 days)|All Subjects population. Only those participants with data available at the indicated time points were analyzed.||Grams||95% Confidence Interval|Least Squares Mean
801399|NCT00972504|Secondary|Weighted Mean of the Individual Components of TNSS (Sneeze, Itch, Rhinorrhoea and Nasal Blockage) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3|On the third dosing day, participants entered the ECC for a duration of 6 hours, 1 hour after receiving their third dose. Time 0 hour was considered as the time that the participant entered the ECC. Nasal blockage, itch, sneeze and rhinorrhoea was scored on a categorical scale from 0 to 3 (0: no symptoms; 1: mild symptoms; 2: moderate symptoms; 3: severe symptoms). The total TNSS ranged from 0-12 point, with low score indicates well-being and higher score indicates more severity. Individual symptoms scores was summed to produce the TNSS at each time point (0, 20, 40, 60, 80, 100, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300, 320, 340 and 360 minutes). The adjusted mean is provided as least square mean.|Day 3 of each treatment period (approximately up to 63 days)|All Subjects population. Only those participants with data available at the indicated time points were analyzed.||Score on a scale||95% Confidence Interval|Least Squares Mean
801422|NCT00972543|Secondary|Haematology Laboratory Assessments - White Cell Count|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits|||participants|||Number
801423|NCT00972543|Secondary|Haematology Laboratory Assessments - Red Cell Count|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits|||participants|||Number
801400|NCT00972504|Primary|Weighted Mean TNSS (Sneeze, Itch, Rhinorrhoea and Nasal Blockage) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3|On the third dosing day, participants entered the ECC for a duration of 6 hours, 1 hour after receiving their third dose. Time 0 hour was considered as the time that the participant entered the ECC. Nasal blockage, itch, sneeze and rhinorrhoea was scored on a categorical scale from 0 to 3 (0: no symptoms; 1: mild symptoms; 2: moderate symptoms; 3: severe symptoms). The total TNSS ranged from 0-12 point, with low score indicates well-being and higher score indicates more severity. Individual symptoms scores was summed at each time point (0, 20, 40, 60, 80, 100, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300, 320, 340 and 360 minutes). The adjusted mean is provided as least square mean.|Day 3 of each treatment period (approximately up to 63 days)|The all subjects population was used defined as all participants who receive at least one dose of study medication. Only those participants with data available at the indicated time points were analyzed.||Score on a scale||95% Confidence Interval|Least Squares Mean
801401|NCT00972530|Primary|Relapse of Arthritis|The patients were followed for six months and if signs and symptoms recurred in between the patients were told to contact the rheumatology department. In such cases the elbow was re-examined and if a relapse could be confirmed the duration of effect was recorded and if needed the patient was offered another injection.|Regular visits at one week, 3 months and 6 months.|||participants|||Number
801402|NCT00972543|Secondary|Negative Urinary Human Chorionic Gonadotrophin (hCG) Pregnancy Test|A urinary human chorionic gonadotrophin (hCG) pregnancy test will be conducted for all female subjects of childbearing potential prior to entering the study.|Measured at screening (Day -14 to Day -1)|||participants|||Number
801403|NCT00972543|Secondary|Negative Serum Human Chorionic Gonadotrophin (hCG) Pregnancy Test|A serum human chorionic gonadotrophin (hCG) pregnancy test will be conducted for all female subjects of childbearing potential prior to entering the study.|Measured at screening (Day -14 to Day -1)|||participants|||Number
801404|NCT00972543|Secondary|Clinical Chemistry Laboratory Assessments - C Reactive Protein|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits|||participants|||Number
801405|NCT00972543|Secondary|Clinical Chemistry Laboratory Assessments - Alkaline Phosphatase|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits|||participants|||Number
801406|NCT00972543|Secondary|Clinical Chemistry Laboratory Assessments - Gamma Glutamyl Transpeptidase|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits|||participants|||Number
801407|NCT00972543|Secondary|Clinical Chemistry Laboratory Assessments - Alanine Transaminase|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits|||participants|||Number
801408|NCT00972543|Secondary|Clinical Chemistry Laboratory Assessments - Aspartate Transaminase|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits|||participants|||Number
801409|NCT00972543|Secondary|Clinical Chemistry Laboratory Assessments - Calcium|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits|||participants|||Number
801410|NCT00972543|Secondary|Clinical Chemistry Laboratory Assessments - Total Protein|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits|||participants|||Number
801411|NCT00972543|Secondary|Clinical Chemistry Laboratory Assessments - Total Bilirubin|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits|||participants|||Number
801412|NCT00972543|Secondary|Clinical Chemistry Laboratory Assessments - Creatinine|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits|||participants|||Number
801413|NCT00972543|Secondary|Clinical Chemistry Laboratory Assessments - Urea|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits|||participants|||Number
801414|NCT00972543|Secondary|Clinical Chemistry Laboratory Assessments - Potassium|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits|||participants|||Number
801415|NCT00972543|Secondary|Clinical Chemistry Laboratory Assessments - Sodium|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits|||participants|||Number
801416|NCT00972543|Secondary|Haematology Laboratory Assessments - Basophils|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits|||participants|||Number
801417|NCT00972543|Secondary|Haematology Laboratory Assessments - Eosinophils|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits|||participants|||Number
801418|NCT00972543|Secondary|Haematology Laboratory Assessments - Monocytes|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits|||participants|||Number
801431|NCT00972543|Secondary|Participants With Direct Physical Examination Abnormalities|Physical examination included Lymph node palpation, Abdominal palpation, Auscultation of the lung, heart and intestinum|Measured at at screening, Day 0, Week 4, Week 12, and Early Termination visits|Results not analysed due to early termination of the study|||||
801432|NCT00972543|Primary|Dynamic Physician's Global Assessment of Change (dPGA)|The global response of all psoriatic lesions to therapy compared with the baseline condition using Study Day 0 Body Diagrams will be evaluated using the following categories: Cleared (100% improvement), Excellent (75-99 improvement), Good (50-74% improvement), Fair (25-49% improvement), Slight (1-24% improvement), Unchanged, or Worse|Measured at Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits|Results not analysed due to early termination of the study|||||
801433|NCT00972543|Primary|Static Physician Global Assessment (SPGA)|The global response of all psoriatic lesions to therapy compared with the baseline condition using Study Day 0 Body Diagrams will be evaluated using the following categories: Cleared (100% improvement), Excellent (75-99 improvement), Good (50-74% improvement), Fair (25-49% improvement), Slight (1-24% improvement), Unchanged, or Worse|Measured at Screening, Day 0 and Day 7|Results not analysed due to early termination of the study|||||
801434|NCT00972543|Primary|Psoriasis Area and Severity Index (PASI)|Minimum possible score 0, maximum possible score 72.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits|Results not analysed due to early termination of the study|||||
801435|NCT00972543|Primary|Static Physician Global Assessment Hands and Feet (sPGA – H&F)|Minimum possible score 0, maximum possible score 4.|Measured at Screening, Day 0, Day 7, Week 4, Week 8, Week 12, Week 16, Week 20 visits and Early Termination Visit|Results not analysed due to early termination of the study|||||
801436|NCT00972543|Primary|Palmoplantar Pustular Psoriasis Area and Severity Index (PPPASI)|Minimum possible score 0, maximum possible score 72.|Measured at Screening, Day 0, Day 7, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits|Results not analysed due to early termination of the study|||||
801437|NCT00972595|Primary|Peak Plasma Concentration (Cmax) for Ondansetron||24 hours post-dose|All 44 of the subjects who completed both Treatment OE U.K. tablet and U.K. tablet were included in the statistical analysis.||ng/mL||Standard Deviation|Least Squares Mean
801438|NCT00972595|Primary|Plasma Area Under The Concentration Versus Time Curve (AUC(0-infinity)) For Ondansetron||0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, and 24 hours postdose|All 44 of the subjects who completed both Treatments OE U.K. tablet and U.K. tablet were included in the statistical analysis.||ng*hr/mL||Standard Deviation|Least Squares Mean
801439|NCT00972621|Secondary|Postoperative Mean Endothelial Cell Count|mean endothelial cell count (measured by Konan specular microscope) at 3 months|3 months postoperative|Results based on Intent-to-Treat (ITT) population (i.e., population based on the intended randomization scheme, which specified 199 Vitrax II subjects and 201 Viscoat subjects). Study statistical analysis plan specified reporting mean endothelial cell count for ITT population, which differs from the safety population used in the Participant Flow.||number of endothelial cells||Standard Deviation|Mean
801440|NCT00972621|Primary|Percent of Intraocular Pressure Spikes 30 mm Hg or Greater Postoperatively|Cumulative rate of Intraoperative Pressure (IOP) spikes 30 mm Hg (millimeters of mercury) or greater measured postoperatively through three months.|3 months postoperative|Results based on Intent-to-Treat (ITT) population (i.e., population based on the intended randomization scheme, which specified 199 Vitrax II subjects and 201 Viscoat subjects). Study statistical analysis plan specified reporting IOP spikes ≥ 30 mmHg for ITT population, which differs from the safety population used in the Participant Flow.||percentage of participants||90% Confidence Interval|Number
801441|NCT00972725|Secondary|Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations|Antibody concentrations were expressed as geometric mean concentrations (GMCs), given in milli-enzyme-linked immunosorbent assay (ELISA) units per millilitre (mEL.U/mL).|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||mEL.U/mL||95% Confidence Interval|Geometric Mean
801442|NCT00972725|Secondary|Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines|Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS. Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool_F4co) or by adding individual frequencies of the CD4+ T cell response to each of the 4 antigens (F4co_est).|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||T cells/million cells||Inter-Quartile Range|Median
801443|NCT00972725|Secondary|Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines|Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS. Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool_F4co) or by adding individual frequencies of the CD4+ T cell response to each of the 4 antigens (F4co_est).|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||T cells/million cells||Inter-Quartile Range|Median
801444|NCT00972725|Secondary|Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines|Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS. Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool_F4co) or by adding individual frequencies of the CD4+ T cell response to each of the 4 antigens (F4co_est).|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||T cells/million cells||Inter-Quartile Range|Median
801535|NCT00973349|Secondary|Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age|Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.|7 days after vaccination|The analysis was on the safety set.||Participants|||Number
811710|NCT01059760|Primary|Change From Baseline in Participant Hematocrit When Fasting and Fed||Baseline and 3 days|||% of red blood cells to whole blood||Standard Deviation|Mean
801445|NCT00972725|Secondary|Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines|Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS. Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool_F4co) or by adding individual frequencies of the CD4+ T cell response to each of the 4 antigens (F4co_est).|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||T cells/million cells||Inter-Quartile Range|Median
801446|NCT00972725|Secondary|Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines|Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||T cells/million cells||Inter-Quartile Range|Median
801447|NCT00972725|Secondary|Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines|Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||T cells/million cells||Inter-Quartile Range|Median
801448|NCT00972725|Secondary|Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines|Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||T cells/million cells||Inter-Quartile Range|Median
801449|NCT00972725|Secondary|Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines|Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||T cells/million cells||Inter-Quartile Range|Median
801450|NCT00972725|Secondary|Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines|Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||T cells/million cells||Inter-Quartile Range|Median
801451|NCT00972725|Secondary|Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines|Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||T cells/million cells||Inter-Quartile Range|Median
801452|NCT00972725|Secondary|Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines|Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||T cells/million cells||Inter-Quartile Range|Median
801453|NCT00972725|Secondary|Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines|Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||T cells/million cells||Inter-Quartile Range|Median
801454|NCT00972725|Secondary|Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines|Magnitude was defined as the frequency of CD4+ T cells group-specific antigen (Gag) proteins 17, 24, negative regulatory factor (Nef), reverse transcriptase (RT) and fusion protein of all 4 antigens (F4co). Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool_F4co) or by adding individual frequencies of the CD8+ T cell response to each of the 4 antigens (F4co_est). Among the cytokines expressed were IL-2, TNF-α and INF-γ.|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||T cells/million cells||Inter-Quartile Range|Median
801455|NCT00972725|Secondary|Number of Subjects With Frequency of Cluster of Differentiation (CD4+) T Cells Expressing at Least 2 Cytokines to at Least 1, 2, 3 or All 4 Antigens|Among expressed cytokines were interleukin-2 (IL-2), tumour necrosis factor alpha (TNF-α) and interferon gamma (INF-γ), as determined by ICS.|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||Subjects|||Number
801456|NCT00972725|Secondary|Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine|Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS. Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool_F4co) or by adding individual frequencies of the CD8+ T cell response to each of the 4 antigens (F4co_est).|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||T cells/million cells||Inter-Quartile Range|Median
801703|NCT00976703|Primary|Time to Delivery||an average of 20 hours, up to 40 hours|In order to find a 20% difference with a 40% standard deviation, power of 90%, and alpha of 0.05, we estimated we needed 86 patients in each arm. We aimed to recruit 194 patients to account for potential dropouts and missing data.||hours||Standard Deviation|Mean
801457|NCT00972725|Secondary|Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine|Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS. Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool_F4co) or by adding individual frequencies of the CD8+ T cell response to each of the 4 antigens (F4co_est).|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||T cells/million cells||Inter-Quartile Range|Median
801458|NCT00972725|Secondary|Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine|Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS. Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool_F4co) or by adding individual frequencies of the CD8+ T cell response to each of the 4 antigens (F4co_est).|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||T cells/million cells||Inter-Quartile Range|Median
801459|NCT00972725|Secondary|Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine|Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS. Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool_F4co) or by adding individual frequencies of the CD8+ T cell response to each of the 4 antigens (F4co_est).|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||T cells/million cells||Inter-Quartile Range|Median
801460|NCT00972725|Secondary|Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine|Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||T cells/million cells||Inter-Quartile Range|Median
801461|NCT00972725|Secondary|Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine|Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||T cells/million cells||Inter-Quartile Range|Median
801462|NCT00972725|Secondary|Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine|Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||T cells/million cells||Inter-Quartile Range|Median
801463|NCT00972725|Secondary|Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine|Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||T cells/million cells||Inter-Quartile Range|Median
801464|NCT00972725|Secondary|Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine|Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||T cells/million cells||Inter-Quartile Range|Median
801465|NCT00972725|Secondary|Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine|Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or cluster of differentiation 40-ligand (CD40-L) cytokines as determined by ICS.|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||T cells/million cells||Inter-Quartile Range|Median
801466|NCT00972725|Secondary|Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine|Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||T cells/million cells||Inter-Quartile Range|Median
801467|NCT00972725|Secondary|Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine|Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or cluster of differentiation 40-ligand (CD40-L) cytokines as determined by ICS.|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||T cells/million cells||Inter-Quartile Range|Median
801468|NCT00972725|Secondary|Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine|Magnitude was defined as the frequency of CD8+ T cells group-specific antigen (Gag) proteins 17, 24; negative regulatory factor (Nef); reverse transcriptase (RT) and fusion protein of all 4 antigens (F4co). Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool_F4co) or by adding individual frequencies of the CD8+ T cell response to each of the 4 antigens (F4co_est). Among the cytokines expressed were IL-2, TNF-α and INF-γ.|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||T cells/million cells||Inter-Quartile Range|Median
801469|NCT00972725|Primary|Levels of Haematological and Biochemical Parameters|Among haematological and biochemical parameters determined were alanine aminotransferase [ALT], aspartate aminotransferase [ASA], basophils [BASO], creatinine [CREA], eosinophils [EOS], haematocrit [HAEM], haemoglobin [HAEMO], lymphocytes [LYMPH], monocytes [MONO], neutrophils [NEU], platelets [PLA], red blood cells [RBC], urea [UR] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were – unknown, below, within and above.|At Day 180|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Subjects|||Number
801470|NCT00972725|Primary|Levels of Haematological and Biochemical Parameters|Among haematological and biochemical parameters determined were alanine aminotransferase [ALT], aspartate aminotransferase [ASA], basophils [BASO], creatinine [CREA], eosinophils [EOS], haematocrit [HAEM], haemoglobin [HAEMO], lymphocytes [LYMPH], monocytes [MONO], neutrophils [NEU], platelets [PLA], red blood cells [RBC], urea [UR] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were – unknown, below, within and above.|At Day 30|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Subjects|||Number
801471|NCT00972725|Primary|Levels of Haematological and Biochemical Parameters|Among haematological and biochemical parameters determined were alanine aminotransferase [ALT], aspartate aminotransferase [ASA], basophils [BASO], creatinine [CREA], eosinophils [EOS], haematocrit [HAEM], haemoglobin [HAEMO], lymphocytes [LYMPH], monocytes [MONO], neutrophils [NEU], platelets [PLA], red blood cells [RBC], urea [UR] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were – unknown, below, within and above.|At Day 7|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Subjects|||Number
801472|NCT00972725|Primary|Levels of Haematological and Biochemical Parameters|Among haematological and biochemical parameters determined were alanine aminotransferase [ALT], aspartate aminotransferase [ASA], basophils [BASO], creatinine [CREA], eosinophils [EOS], haematocrit [HAEM], haemoglobin [HAEMO], lymphocytes [LYMPH], monocytes [MONO], neutrophils [NEU], platelets [PLA], red blood cells [RBC], urea [UR] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were – unknown, below, within and above.|At Day 0|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Subjects|||Number
801473|NCT00972725|Primary|Number of Subjects With AEs of Specific Interest and Immune-Mediated Disorders (IMDs)|Adverse events of specific interest include auto-immune diseases (AID) and immune mediated disorders such as neurological/demyelinating events, rheumatic and connective diseases, autoimmune endocrine diseases, inflammatory bowel diseases, autoimmune blood disorders, inflammatory skin disorders, other autoimmune/inflammatory events.|During the entire study period (from Day 0 up to Day 360)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Subjects|||Number
801474|NCT00972725|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Day 0 up to Day 360)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Subjects|||Number
801475|NCT00972725|Primary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset out-side the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 32 Day (Days 2-29) post-chloroquine administration and during the 30 Day (Days 0-29) post-vaccine administration period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Subjects|||Number
801476|NCT00972725|Primary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms were fatigue, temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastrointestinal symptoms [nausea, vomiting, diarrhoea and/or abdominal pain] and headache. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7 Day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Subjects|||Number
801477|NCT00972725|Primary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.|During the 7 Day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Subjects|||Number
801478|NCT00972725|Primary|Number of Subjects With Frequency of Cluster of Differentiation 8 (CD8+) T Cells Expressing at Least One Cytokine to at Least 1, 2, 3 or All 4 Antigens|Among expressed cytokines were interleukin-2 (IL-2), tumour necrosis factor alpha (TNF-α) and interferon gamma (INF-γ), as determined by intracellular cytokine staining (ICS).|At Day 14|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||Subjects|||Number
801493|NCT00972816|Secondary|Antibody Response Based on Baseline Seropositivity|"Subgroup analysis based on Subjects with seropositivity (pre-vaccination HI antibody titer < 1:10 and prevaccination HI antibody titer ≥ 1:10) at baseline.
Subgroups with baseline HI titer < 1:10: PPS Day 1–29 analysis set. N= 104, 116, 111, 107, 109, 113,120, and 103 for Groups A, B, C, D, E, F, G, and H respectively.
Subgroups with baseline HI titer ≥ 1:10: PPS Day 1–29 analysis set. N= 39, 33, 38, 39, 38, 34, 24, and 41 for Groups A, B, C, D, E, F, G, and H respectively."|Day 22, Day 29 and Day 43|||percentage of Subjects||95% Confidence Interval|Number
801479|NCT00972738|Secondary|Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score After the 2-week Treatment Period|Patients completed a validated, self-administered Rhinoconjunctivitis Quality-of-Life Questionnaire, which included 28 questions on a 7-point scale [Score 0 (best) to 6 (worst)], across 7 domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. The individual domain scores were calculated as the average values of all scores within a domain, then the scores for the 7 domains were averaged for the overall score.|Baseline and at the end of 2-week treatment period|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and a week 2 measurement were included. No missing values were imputed.||Scores on a scale||95% Confidence Interval|Least Squares Mean
801480|NCT00972738|Secondary|Physician's Global Evaluation of Allergic Rhinitis at the End of the 2-week Treatment Period|An evaluation by the physician, administered at the last visit (or upon discontinuation) using a 7-point scale [Score 0 (very much better) to 6 (very much worse)], of the change in symptoms as compared to the beginning of the study.|End of the 2-week treatment period|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle. Since only 1 measurement was obtained during the treatment period, no missing values were imputed.||Scores on a scale||95% Confidence Interval|Least Squares Mean
801481|NCT00972738|Secondary|Patient's Global Evaluation of Allergic Rhinitis at the End of the 2-week Treatment Period|An evaluation by the patient, administered at the last visit (or upon discontinuation) using a 7-point scale [Score 0 (very much better) to 6 (very much worse)], of the change in symptoms as compared to the beginning of the study.|End of the 2-week treatment period|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle. Since only 1 measurement was obtained during the treatment period, no missing values were imputed.||Scores on a scale||95% Confidence Interval|Least Squares Mean
801482|NCT00972738|Secondary|Mean Change From Baseline in Daytime Eye Symptoms Score Over the 2-week Treatment Period|Mean change from baseline in Daytime Eye Symptoms scores. Patients were asked to rate each of the 4 eye symptoms of tearing, itchy, red, and puffy eyes daily on a 4-point scale [0 (best) to 3 (worst)]. The average of the 4 individual eye symptoms scores was reported as the Daytime Eye Symptoms Score.|Baseline and over the 2-week treatment period|The primary efficacy analyses were based on intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.||Scores on a scale||95% Confidence Interval|Least Squares Mean
801483|NCT00972738|Secondary|Mean Change From Baseline in Nighttime Symptoms Score Over the 2-week Treatment Period|Mean change from baseline in Nighttime Symptoms Score. Patients were asked to rate each symptoms of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings daily on a 4-point [Scale 0 (best) to 3 (worst)]. The average of the individual symptoms scores was reported as the Nighttime Symptoms Score.|Baseline and over the 2-week treatment period|The primary efficacy analyses were based on intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.||Scores on a scale||95% Confidence Interval|Least Squares Mean
801484|NCT00972738|Primary|Mean Change From Baseline in Daytime Nasal Symptoms Score Over the 2-week Treatment Period|Mean change from baseline in Daytime Nasal Symptoms. Patients were asked to rate each of the 4 nasal symptoms of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4-point scale [Score 0 (best) to 3 (worst)]. The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal Symptoms Score.|Baseline and over the 2-week treatment period|The primary efficacy analyses were based on intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.||Scores on a scale||95% Confidence Interval|Least Squares Mean
801485|NCT00972777|Secondary|Microbial Eradication|The absence of ocular bacteria that were present at or above pathogenic threshold levels at baseline.|Visit 3|Microbial Eradication at Visit 3, (LOCF), mITT Population.||eyes|||Number
801486|NCT00972777|Secondary|Clinical Resolution|The absence of both conjunctival discharge and bulbar conjunctival injection.|Visit 3|Clinical Resolution at Visit 3, (LOCF) mITT Population.||eyes|||Number
801487|NCT00972777|Primary|Microbial Eradication|The absence of ocular bacteria that were present at or above pathogenic threshold levels at baseline.|Visit 2|Microbial Eradication at Visit 2, (LOCF), mITT Population.||eyes|||Number
801488|NCT00972777|Primary|Clinical Resolution|The absence of both conjunctival discharge and bulbar conjunctival injection.|Visit 2|Clinical Resolution at Visit 2, (LOCF), mITT Population.||eyes|||Number
801489|NCT00972816|Secondary|Number of Participants Reporting Unsolicited Adverse Events (AEs)|Safety was measured in terms of the Number of Participants Reporting Unsolicited AEs. Source Vocabulary Name: MedDRA (13.1)|Safety monitoring periods were the Primary Period: Day 1 (1st vaccination) through ≤21 days post second vaccination, and the Follow-up Period: >21 Days post second vaccination to 12 months after second vaccination|The analysis was done on unsolicited safety set population.||Subjects|||Number
801490|NCT00972816|Secondary|Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination|Solicited local and systemic reactions were assessed after the second vaccination by vaccine group.Source Vocabulary Name: MedDRA (13.1)|7 days after second vaccination|The analysis was performed on safety set population||Participant|||Number
801491|NCT00972816|Secondary|Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination|Solicited local and systemic reactions were assessed after the first vaccination by vaccine group. Source Vocabulary Name: MedDRA (13.1).|7 days after first vaccination|The analysis was performed on safety set population||Participants|||Number
801492|NCT00972816|Secondary|Geometric Mean Titers (GMTs) Based on Baseline Seropositivity|"Subgroup analysis based on Subjects with seropositivity (pre-vaccination HI antibody titer < 1:10 and prevaccination HI antibody titer ≥ 1:10) at baseline.
Immunogenicity responses in subjects who are seropositive (A/H1N1 2009 HI titer ≥ 1:10) at Baseline [Day 1 (pre-vaccination)] as compared to those who are seronegative (HI titer < 1:10)."|Day 1, Day 22, Day 29, Day 43|||Titers||95% Confidence Interval|Geometric Mean
801529|NCT00967486|Primary|Overall Perioperative Complications Between Selective vs. Routine Shunting.|perioperative complication included at least one of transient ischemic attack (TIA), hemorrhage, myocardial infarction [MI], or asymptomatic carotid thrombosis or congestive heart failure.|Within 30 days of enrollment|||Participants|||Number
811711|NCT01059760|Primary|Change From Baseline in Participant Red Blood Cell Count (RBC) When Fasting and Fed||Baseline and 3 days|||cells x 10^6/mL||Standard Deviation|Mean
801494|NCT00972816|Secondary|Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010|"Immunogenicity was measured in terms of GMTs of Subgroups with receipt of recent seasonal vaccination. Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines
Subgroups without recent seasonal flu vaccine:
PPS Day 1, Day 1–22 and Day 1–43 analysis set. N= 141, 147, 150, 148, 146, 146, 150, and 146 for Groups A, B, C, D, E, F, G, and H respectively.
PPS Day 1–29 analysis set. N= 132, 140, 143, 139, 138, 136, 139, and 138 for Groups A, B, C, D, E, F,G, and H respectively.
Subgroups with recent seasonal flu vaccine:PPS Day 1–22 and Day 1-43 analysis set. N= 11, 9, 6, 8, 9, 11, 6, and 7 for Groups A, B, C, D, E, F, G,and H respectively.
PPS Day 1–29 analysis set. N= 11, 9, 6, 7, 9, 11, 5, and 6 for Groups A, B, C, D, E, F, G, and H respectively"|Day 1, Day 22, Day 29, Day 43|The analysis was done on PPS population.||Titers||95% Confidence Interval|Geometric Mean
801495|NCT00972816|Secondary|Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010.|HI antibody assay (used to assess immune responses in subjects following vaccination) according to the Committee for Medicinal Products for Human Use (CHMP) guidance: in adults ages 18 to 60 years are:The percentage of subjects with seroconversion or significant increase in HI antibody is > 40%.The percentage of subjects achieving an HI titer ≥ 40 is > 70% and The GMR is > 2.5. All 3 criteria (seroconversion/significant increase, HI antibody titer ≥ 40, and GMR) had to be fulfilled to establish immunogenicity.Subgroup analysis based on receipt of recent seasonal vaccination. Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines.Subgroups without recent seasonal flu vaccine:PPS Day1, Day 1–22 and Day1–43 analysis set. N= 141, 147, 150, 148, 146, 146, 150, and 146 for Groups A, B, C, D, E, F, G, and H respectively. PPS Day 1–29 analysis set. N= 132, 140, 143, 139, 138, 136, 139, and 138 for Groups A, B, C, D, E, F, G,and H respectively.|Day 22, Day 29, Day 43|The analysis was done on PPS population||percentage of Subjects||95% Confidence Interval|Number
801496|NCT00972816|Secondary|Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group|"Immunogenicity was measured in terms of GMTs After each vaccination by vaccine Group.
PPS Day1–29 analysis set: N=143, 149, 149, 146, 147, 147, 144, and 144 for Groups A, B, C, D, E, F, G, and H respectively.
PPS Day 1–202 analysis set. N= 82, 85, 84, 84, 86, 87, 82, and 79 for Groups A, B, C, D, E, F, G, and H respectively."|Day 22, Day 29, Day 43, Day 202 and Day 387|The analysis was performed on per protocol set (PPS) population||Titers||95% Confidence Interval|Geometric Mean
801497|NCT00972816|Primary|Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations|"HI antibody assay (used to assess immune responses in subjects following vaccination) according to the Center for Biologics Evaluation and Research (CBER) guidance for <65 years of age: The lower bound of the two-sided 95% Confidence Interval (CI) for the percentages of subjects achieving seroconversion for HI antibody should be ≥ 40% and the lower bound of the two-sided 95% CI for the percentages of subjects achieving an HI antibody titer ≥ 1:40 should be ≥ 70%. Both criteria (seroconversion and HI antibody titer ≥ 40) had to be fulfilled to establish immunogenicity.
PPS Day 1–29 analysis set: N= 143, 149, 149, 146, 147, 147, 144, and 144 for Groups A, B, C, D, E, F,G,and H respectively.
PPS Day 1–202 analysis set: N= 82, 85, 84, 84, 86, 87, 82, and 79 for Groups A, B, C, D, E, F, G, and H respectively.
PPS Day 1–387 analysis set: N= 55, 63, 61, 58, 61, 65, 59, and 63 for Groups A, B, C, D, E, F, G, and H respectively."|Day 22, Day 29, Day 43, Day 202 and Day 387|The analysis was performed on per protocol set (PPS) population||percentage of subjects||95% Confidence Interval|Number
801498|NCT00972959|Secondary|Bone Remodelling|Bone remodelling was studied by the measurement of the following serum indices on day 21 of cycle 4 (day 84) using an enzyme-linked immunosorbent assay (ELISA): bone formation marker [bone-specific alkaline phosphatase (bALP) ].|day 168|Out of the 17 patients enrolled 12 patients completed the 8 VD cycles, 2 patients 6 VD cycles (due to peripheral neuropathy), 1 patient 5 VD cycles (and then progressed) and 2 patients died after receiving 1 and 2 VD cycles (respectively)||U/L||Full Range|Median
801499|NCT00972959|Secondary|Bone Remodelling|Bone remodelling was studied by the measurement of the following serum indices on day 21 of cycle 4 (day 84) using an enzyme-linked immunosorbent assay (ELISA) bone formation marker [bone-specific alkaline phosphatase (bALP)].|day 84|Out of the 17 patients enrolled 12 patients completed the 8 VD cycles, 2 patients 6 VD cycles (due to peripheral neuropathy), 1 patient 5 VD cycles (and then progressed) and 2 patients died after receiving 1 and 2 VD cycles (respectively)||U/L||Full Range|Median
801500|NCT00972959|Secondary|New Skeletal-related Events (SRE: Pathologic Fractures, Need for Bone Radiation Therapy or Surgery)|New Skeletal-related Events (SRE: Pathologic Fractures, Need for Bone Radiation Therapy or Surgery) after 18 months post VD|18 months|Out of the 17 patients enrolled 12 patients completed the 8 VD cycles, 2 patients 6 VD cycles (due to peripheral neuropathy), 1 patient 5 VD cycles (and then progressed) and 2 patients died after receiving 1 and 2 VD cycles (respectively)||participants|||Number
801501|NCT00972959|Secondary|New Skeletal-related Events (SRE: Pathologic Fractures, Need for Bone Radiation Therapy or Surgery)|New Skeletal-related events (SRE: pathologic fractures, need for bone radiation therapy or surgery) following 8 cycles (day 168) of therapy|day 168|Out of the 17 patients enrolled 12 patients completed the 8 VD cycles, 2 patients 6 VD cycles (due to peripheral neuropathy), 1 patient 5 VD cycles (and then progressed) and 2 patients died after receiving 1 and 2 VD cycles (respectively)||participants|||Number
801502|NCT00972959|Secondary|Skeletal Survey for New Osteolytic Lesions/Fractures|Skeletal survey was measured using conventional radiography [imaging of the whole skeleton (skull, cervical spine, thoracic spine, lumbar spine, pelvis, humeri, femoral bones)] every 6 months for up to 18 months|18 months|Out of the 17 patients enrolled 12 patients completed the 8 VD cycles, 2 patients 6 VD cycles (due to peripheral neuropathy), 1 patient 5 VD cycles (and then progressed) and 2 patients died after receiving 1 and 2 VD cycles (respectively)||participants|||Number
801503|NCT00972959|Secondary|Skeletal Survey for New Osteolytic Lesions/Fractures|Skeletal survey was measured using conventional radiography [imaging of the whole skeleton (skull, cervical spine, thoracic spine, lumbar spine, pelvis, humeri, femoral bones)] on day 21 of cycle 8 (day 168)|day 168|Out of the 17 patients enrolled 12 patients completed the 8 VD cycles, 2 patients 6 VD cycles (due to peripheral neuropathy), 1 patient 5 VD cycles (and then progressed) and 2 patients died after receiving 1 and 2 VD cycles (respectively)||participants|||Number
801530|NCT00967551|Secondary|Proportion of Children With Respiratory Infections|Number of children with respiratory infections divided by the total number of children in the group|6 months|All children enrolled||percentage of participants|||Number
801504|NCT00972959|Secondary|Bone Pain|"Bone pain was measured with the use of the Visual Analogue Scale on day 21 of cycle 8 (day 168).
Bone pain was measured with the use of the Visual Analogue Scale. The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.
The VAS for Bone Pain was constructed as follows:
None Mild Moderate Severe Worst possible 1,2 3,4 5,6 7,8 9,10 Lower values are considered to be of a better outcome, higher values are considered to be of a worst outcome."|On the day 168|Out of the 17 patients enrolled 12 patients completed the 8 VD cycles, 2 patients 6 VD cycles (due to peripheral neuropathy), 1 patient 5 VD cycles (and then progressed) and 2 patients died after receiving 1 and 2 VD cycles (respectively)||units on a scale||Full Range|Median
801505|NCT00972959|Secondary|Bone Pain|"Bone pain was measured with the use of the Visual Analogue Scale on day 21 of cycle 4 (day 84).
Bone pain was measured with the use of the Visual Analogue Scale. The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.
The VAS for Bone Pain was constructed as follows:
None Mild Moderate Severe Worst possible 1,2 3,4 5,6 7,8 9,10 Lower values are considered to be of a better outcome, higher values are considered to be of a worst outcome."|On the day 84|Out of the 17 patients enrolled 12 patients completed the 8 VD cycles, 2 patients 6 VD cycles (due to peripheral neuropathy), 1 patient 5 VD cycles (and then progressed) and 2 patients died after receiving 1 and 2 VD cycles (respectively)||units on a scale||Full Range|Median
801506|NCT00972959|Secondary|Bone Remodelling|Bone remodelling was studied by the measurement of the following serum indices on day 21 of cycle 8 (day 168) using an enzyme-linked immunosorbent assay (ELISA): i) bone resorption marker C-terminal cross-linking telopeptide of collagen type I (CTX) and ii) bone formation marker [osteocalcin (OC)].|day 168|Out of the 17 patients enrolled 12 patients completed the 8 VD cycles, 2 patients 6 VD cycles (due to peripheral neuropathy), 1 patient 5 VD cycles (and then progressed) and 2 patients died after receiving 1 and 2 VD cycles (respectively)||ng/ml||Full Range|Median
801507|NCT00972959|Secondary|Bone Remodelling|Bone remodelling was studied by the measurement of the following serum indices on day 21 of cycle 4 (day 84) using an enzyme-linked immunosorbent assay (ELISA): i) bone resorption marker C-terminal cross-linking telopeptide of collagen type I (CTX) and ii) bone formation markers [osteocalcin (OC)].|day 84|Out of the 17 patients enrolled 12 patients completed the 8 VD cycles, 2 patients 6 VD cycles (due to peripheral neuropathy), 1 patient 5 VD cycles (and then progressed) and 2 patients died after receiving 1 and 2 VD cycles (respectively)||ng/ml||Full Range|Median
801508|NCT00972959|Secondary|Bone Mineral Density (BMD)|BMD of the lumbar spine (L1–L4, anteroposterior view) and femoral neck (FN) was measured by Dual Energy X-Absorptiometry scan (DEXA-scan) using a Hologic QDR-1000 scanner on day 21 of cycle 8 (day 168)|day 168|Out of the 17 patients enrolled 12 patients completed the 8 VD cycles, 2 patients 6 VD cycles (due to peripheral neuropathy), 1 patient 5 VD cycles (and then progressed) and 2 patients died after receiving 1 and 2 VD cycles (respectively)||T-score||Full Range|Median
801509|NCT00972959|Primary|Bone Mineral Density (BMD)|BMD of the lumbar spine (L1–L4, anteroposterior view) and femoral neck (FN) was measured by dual energy X-ray absorptiometry (DXA) using a Hologic QDR-1000 scanner on day 21 of cycle 4 (day 84)|day 84|Out of the 17 patients enrolled 12 patients completed the 8 VD cycles, 2 patients 6 VD cycles (due to peripheral neuropathy), 1 patient 5 VD cycles (and then progressed) and 2 patients died after receiving 1 and 2 VD cycles (respectively)||T-scores||Full Range|Median
801510|NCT00967330|Secondary|Time to Treatment Failure||From baseline until end of study (up to 4.5 years)|Data for this outcome measure were not collected as this outcome was removed as per changes in planned analysis.||years||Full Range|Median
801511|NCT00967330|Secondary|Percentage of Participants Who Received Corticosteroid for Glioblastoma|Participants used corticosteroids for the glioblastoma condition. Corticosteroids included dexamethasone, methylprednisone, fortecortin, hydrocortisone, urbason, and prednisolone.|From baseline to Month 6|The safety population (SAF) was defined to include all participants who received at least 1 dose of study medication. Data were analyzed according to the treatment actually received (as treated).||percentage of participants|||Number
801512|NCT00967330|Secondary|Change From Baseline for Karnofsky Performance Status (KPS) Score at Baseline, Post-Baseline (up to Month 30)|KPS is an 11-level score (0, 10, 20, 30, 40, 50, 60, 70, 80, 90, and 100) which ranges between 0 (death) to 100 (complete healthy status); a higher score represents a higher ability to perform daily tasks. Deterioration in KPS was defined as decrease of 20 or more points in KPS score.|Baseline, Post-Baseline (up to Month 30)|ITT population||units on a scale||95% Confidence Interval|Least Squares Mean
801513|NCT00967330|Secondary|Change From Baseline for Mini-Mental Status Examination (MMSE) at Baseline, Post-Baseline (up to Month 30)|The MMSE briefly measures orientation to time and place, immediate recall, short-term verbal memory, calculation, language and construct ability. Each area tested had a designated point value, the total score can range from 0 to 30, with a higher score indicating better function.|Baseline, Post-Baseline (up to Month 30)|ITT population.||units on a scale||95% Confidence Interval|Least Squares Mean
801514|NCT00967330|Secondary|Change From Baseline for EORTC QLQ Brain Neoplasm 20 (BN20) at Baseline, Post-Baseline (up to Month 30)|EORTC QLQ-BN20 consisted of 20 items assessing visual disorders, motor dysfunction, communication deficit, various disease symptoms (e.g. headaches and seizures), treatment toxicities (e.g. hair loss) and future uncertainty. All of the 20 items are rated on a 4 point Likert scale from 1=not at all, 2=a little, 3=quite a bit and 4=very much, and were linearly transformed to a 0-100 scale, with higher scores indicating more severe symptoms.|Baseline, Post-Baseline (up to Month 30)|ITT population||units on a scale||95% Confidence Interval|Least Squares Mean
801531|NCT00967551|Primary|Proportion of Children of Diarrhea Episodes|Number of children with diarrhea divided by the number of children in the group|6 months|All children enrolled||percentage of participants|||Number
801532|NCT00967668|Secondary|Change in Weight|Expected weight change from baseline to 24 months in kilograms based on linear mixed-effects model using all available data. Statistical analyses methods are the same as for the 12-month outcome.|24 months after enrollment|Includes only individuals who formally consented to participate in the second 12 months of the study.||kilograms||95% Confidence Interval|Mean
801533|NCT00967668|Primary|Change in Weight|Expected weight change from baseline to 12 months in kilograms based on linear mixed-effects model using all available data|12 months after enrollment|||Kilograms||95% Confidence Interval|Mean
801515|NCT00967330|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ - C30) at Baseline, Post-Baseline (up to Month 30)|The EORTC QLQ-C30 incorporates: 5 functional scales (physical, role, cognitive, emotional, and social); 9 symptom scales (fatigue, pain, nausea and vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties); and a global health and quality-of-life scale. Most questions used 4 point scale (1 ‘Not at all’ to 4 ‘Very much’; 2 questions used 7-point scale (1 ‘very poor’ to 7 ‘Excellent’). Scores were averaged and transformed to 0-100 scale; higher score for Global Qol/functional scales=better level of functioning or a higher score for symptom scale=greater degree of symptoms. The change in global health status was determined to be the difference in values at baseline and each specific visit. The term ‘’baseline’’ refers to the time of randomization to the maintenance phase.|Baseline, Post-Baseline (up to Month 30)|ITT population.||units on a scale||95% Confidence Interval|Least Squares Mean
801516|NCT00967330|Secondary|Percentage of Participants With Response on FLAIR Imaging|"FLAIR lesions were determined as “stable”, “progressive” or “decreased”. FLAIR lesions was determined as “progressive” only if they were not be attributed to causes apart from tumor infiltration (sequelae of radiation therapy, demyelination, ischemia, infection, seizures, or other treatment effects). Percentage of participants are based on ITT population.
Dis.=Discontinuation."|At screening, Baseline, Month 6 and Therapy Discontinuation (Up to 4.5 years)|ITT population. Here, n = participants with at least 1 assessment during specified time-point.||percentage of participants|||Number
801517|NCT00967330|Secondary|Number of Participants With A Best Overall Response (BOR) of Complete Response (CR) and With A BOR of CR or Partial Response (PR)|BOR was defined as the best response observed for a participant during assessment. Number of participants who had BOR as CR and number of participants who had BOR as CR or PR were reported. Complete response was defined as disappearance of all enhancing tumor on consecutive Gd-MRI scans at least 1 month apart, off steroids, and neurologically stable or improved. Partial response was defined as 50% reduction in size of enhancing tumor on consecutive Gd-MRI scans at least 1 month apart, steroids stable or reduced, and neurologically stable or improved.|4 week after radiotherapy (RT) (up to Week 4), >4 Week after RT (up to Week 8) and Month 6|ITT population. Data were analyzed according to the treatment randomized (as randomized). Here, number of participants analyzed = participants who were evaluable for this outcome and n = participants who were evaluable of specified time-point.||participants|||Number
801518|NCT00967330|Secondary|Percentage of Participants Who Discontinued|Discontinuation was defined as the percentage of participants who permanently discontinued treatment in either treatment arm. Percentage of participant with individual discontinuation reason are reported. CNS: central nervous system; CTCAE: Common Terminology Criteria for Adverse Events . Other reason refers to any other reason than the specified ones.|From baseline until death (up to 4.5 years)|ITT population||percentage of participants|||Number
801519|NCT00967330|Secondary|Overall Survival (OS)|Overall survival was defined as the time from randomization to death from any cause. OS was estimated using Kaplan-Meier method.|From baseline until death (up to 4.5 years)|ITT population. Data were analyzed according to the treatment randomized (as randomized).||Months||95% Confidence Interval|Median
801520|NCT00967330|Secondary|Progression-Free Survival (PFS)|Progression-free survival was defined as the time from randomization to objective tumor progression or death from any cause, whichever came first. Progression was defined as 25% increase in size of enhancing tumor or any new tumor on Gd-MRI scans, or neurologically worse, and steroids stable or increased. PFS was estimated using Kaplan-Meier method.|From baseline to the end of the study (up to 4.5 years)|ITT population. Data were analyzed according to the treatment randomized (as randomized).||Months||95% Confidence Interval|Median
801521|NCT00967330|Primary|Percentage of Participants Achieving Progression-Free Survival (PFS) Without Disease Progression or Death at 6 Months|Progression-free survival was defined as the time from randomization to objective tumor progression or death from any cause, whichever came first. Progression was defined as 25 percent (%) increase in size of enhancing tumor or any new tumor on gadolinium contrast agent magnetic resonance imaging (Gd-MRI) scans, or neurologically worse, and steroids stable or increased. Percentage of participants achieving PFS without disease progression or death was reported.|6 months|Intent-to-treat (ITT) population included participants randomized for whom it cannot be ruled out, that they took study medication at least once and where primary variable was measured at least once under study medication. Data were analyzed according to the treatment randomized (as randomized).||percentage of participants||95% Confidence Interval|Number
801522|NCT00967447|Secondary|Volume of Wound Drainage||From 12 To 37 Days|The trial was stopped due poor enrollment|||||
801523|NCT00967447|Secondary|Major Extra Surgical Site Bleedings||From 12 To 37 Days|The trial was stopped due poor enrollment|||||
801524|NCT00967447|Secondary|Major Bleeding Events (MBE)||From 12 To 37 Days|The trial was stopped due poor enrollment|||||
801525|NCT00967447|Primary|Venous Thromboembolic Events||6 Months|The trial was stopped due poor enrollment|||||
801526|NCT00967473|Primary|Lens Axis Misalignment|Comparison of where the surgeon intended to place the lens axis versus final placement of the lens during the surgical procedure, measured in degrees. This number should be close to zero as there should be minimal difference between the two numbers. This assessment is only for the study eye.|Time of surgery|All implanted subjects were included in this analysis.||Degrees||Full Range|Mean
801527|NCT00967473|Primary|Reduction of Cylinder|Percentage of subjects with reduction in post-operative refractive cylinder (amount of astigmatism) compared to pre-operative keratometric cylinder in the study eye. The post-operative refractive cylinder should be significantly lower than it was pre-operatively.|6 months after surgery on second eye|All implanted subjects were included in this analysis.||Percent reduction of cylinder||95% Confidence Interval|Mean
801528|NCT00967473|Primary|Number of Subjects Reporting Spatial Distortions Related to Intraocular Lens (IOL) Misalignment|Rates of spatial distortions were evaluated by use of the Visual Distortion Questionnaire (VDQ). The VDQ evaluates the rate & frequency of subjects’ experiences with potential visual distortions. The fewer the patients that report visual distortions, the better. The VDQ is a binocular assessment, therfore the subject will use both eyes to evaluate visual distortions.|Before Surgery and 180 days after second eye implant|Per protocol, one subject was excluded from this analysis due to a secondary surgical intervention.||Participants|||Number
811712|NCT01059760|Primary|Change From Baseline in Participant Hemoglobin When Fasting and Fed||Baseline and 3 days|||g/dL||Standard Deviation|Mean
801536|NCT00973349|Secondary|Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age|Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.|7 days after vaccination|The analysis was on the safety set.||Participants|||Number
801537|NCT00973349|Secondary|Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age|Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.|7 days after vaccination|The analysis was on the safety set.||Participants|||Number
801538|NCT00973349|Secondary|Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age|Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.|7 days after vaccination|The population used in analysis was the safety set||Participants|||Number
801539|NCT00973349|Secondary|Geometric Mean Ratio From Baseline, in Participants 18 to 60 Years of Age and ≥61 Years of Age|Immunogenicity evaluation after each vaccination by vaccine group according to CHMP criteria. Geometric Mean Ratio (GMR) of the hemagglutinin inhibition (HI)titers.|21 days after vaccination|The analysis was on the per protocol set. For this analysis, total subjects enrolled were stratified and randomized in two age groups, according to the CHMP criteria, 18 to 60 years and over 60 years of age.||Geometric Mean Ratio||95% Confidence Interval|Geometric Mean
801540|NCT00973349|Secondary|Number of Subjects With Seroconversion and With HI ≥1:40, in Participants ≥61 Years of Age|Immunogenicity evaluation after each vaccination by vaccine group according to CHMP criteria. Seroconversion is defined as the percentage of participants with either a prevaccination HI titer <1:10 and a post vaccination HI titer > 40 or a pre-vaccination HI titer > 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as Hemagglutinin Inhibition (HI) antibody titer ≥1:40.|21 days after each vaccination|The analysis was on the per protocol set.||Participants|||Number
801541|NCT00973349|Primary|Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age|Seroconversion is defined by CBER as the percentage of participants with either a prevaccination HI titer <1:10 and a post vaccination HI titer > 40 or a pre-vaccination HI titer > 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as participants having HI antibody titer ≥1:40.|21 days after each vaccination|The analysis was on the per protocol set.||Participants|||Number
801542|NCT00973349|Secondary|Number of Subjects With Seroconversion and With HI ≥1:40, in Participants 18 to 60 Years of Age|Immunogenicity evaluation after each vaccination by vaccine group according to CHMP (Committee for Medicinal Products for Human Use) criteria. Seroconversion is defined as the percentage of participants with either a prevaccination HI titer <1:10 and a post vaccination HI titer > 40 or a pre-vaccination HI titer > 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as Hemagglutinin Inhibition (HI) antibody titer ≥1:40.|21 days after each vaccination|The analysis was on the per protocol set.||Participants|||Number
801543|NCT00973349|Secondary|Geometric Mean HI Titer by Vaccine Groups; in Participants 18 to 64 Years of Age and ≥65 Years of Age|Geometric mean hemagglutinin inhibition (HI) titer = GMT|21 days after each vaccination|The analysis was on the per protocol set. For this analysis, total subjects enrolled were stratified and randomized in two age groups, according to the CBER criteria, 18 to 64 years and over 64 years of age.||Geometric Mean Titer||95% Confidence Interval|Geometric Mean
801544|NCT00973349|Primary|Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age|Seroconversion is defined by CBER (Center for Biologics Evaluation, Research and Review) as the percentage of participants with either a prevaccination HI titer <1:10 and a post vaccination HI titer > 40 or a pre-vaccination HI titer > 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as participants having HI antibody titer ≥1:40.|21 days after each vaccination|The analysis was based on the per protocol population.||Participants|||Number
801545|NCT00973362|Secondary|ASC-US Study Arm: FDA-Approved HPV DNA Assay Performance for Detecting CIN2+ (All Biopsies)|ASC_US Study Arm: 21+ yrs. Population for Detecting CIN2+ (All Biopsies): FDA-Approved HPV DNA Assay|Baseline Evaluation|74 women with Aptima HPV assay results did not have FDA-Approved HPV DNA test results primarily due to insufficient volume of the cytology specimen for an N of 865 results for the FDA-Approved HPV DNA assay compared to 939 results for the Aptima HPV assay.||participants|||Number
801546|NCT00973362|Secondary|ASC-US Study Arm: Aptima HPV Assay Performance for Detecting CIN2+ (All Biopsies)|ASC-US Study Arm: 21+ yrs. Population: Aptima HPV assay performance on Tigris System for detecting CIN2+ (All Biopsies)|Baseline Evaluation|||participants|||Number
801547|NCT00973362|Primary|Adjunct Study Arm: Compare Assay Performance for FDA-Approved HPV DNA Assay to a FDA-Approved HPV Assay for Detecting CIN2+|Adjunct Study Arm: 30+ yrs. Population: FDA-Approved HPV DNA Assay Performance for Detecting CIN2+: Compare Clinical Performance of the Aptima HPV Assay to a FDA-Approved HPV Assay for Detecting CIN2+|Baseline Evaluation|18 women with Aptima HPV results did not have FDA-Approved DNA test results due to insufficient volume of the cytology specimen for a N of 801 compared to a N of 819 for the Aptima HPV assay results.||participants|||Number
801548|NCT00973362|Primary|Adjunct Study Arm: Compare Assay Performance for Aptima HPV Assay to a FDA-Approved HPV Assay for Detecting CIN2+|Adjunct 30+ yrs. Population: Aptima HPV Assay Performance for Detecting CIN2+: Compare Clinical Performance of the Aptima HPV Assay to a FDA-Approved HPV Assay for Detecting CIN2+|Baseline Evaluation|||participants|||Number
801549|NCT00975975|Secondary|Time to Platelet Engraftment|Time to platelet engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of platelets is defined as the time from day 0 to the first of seven consecutive days after transplantation during which the platelet count is at least 20 x109/l without transfusion support. Patients who did not have platelet engraftment before death will be censored at the date of death. The median and 95% confidence intervals will be provided.|Transplant (Day 0) up to 1 year|All patients enrolled and received treatment, excluding the patient who entered after the stopping rule was met.||days||95% Confidence Interval|Median
801620|NCT00976599|Primary|Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at Pre-dose on Day 35 or Early Termination|Serum samples were analyzed for IL-1ra and IL-15 concentrations using a validated, sensitive and specific ELISA method.|Pre-dose on Day 35 or Early Termination|FAS included all randomized participants who received at least 1 dose of the study medication.||pg/mL||Standard Deviation|Mean
801550|NCT00975975|Secondary|Time to Neutrophil Engraftment|Time to neutrophil engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of neutrophils is defined as the time from day 0 to the date of the first of three consecutive days after transplantation during which the absolute neutrophils count (ANC) is at least 0.5 x109/l. Patients who did not have neutrophil engraftment before death will be censored at the date of death. The median and 95% confidence intervals will be provided.|Transplant (Day 0) up to 1 year|All patients enrolled and received treatment, excluding the patient who entered after the stopping rule was met.||days||95% Confidence Interval|Median
801551|NCT00975975|Primary|Grade 3-4 Acute GVHD Rate|The percent of patients where a patient experienced a Grade 3 or 4 acute GVHD|Transplant (Day 0) up to 1 year|All patients enrolled and received treatment||percentage of participants||95% Confidence Interval|Number
801552|NCT00976027|Other Pre-specified|Number of Participants Reporting Adverse Events of Special Interest (AESIs) and Serious Adverse Events Post-vaccination With Either Fluzone High-Dose and Fluzone|Adverse events of special interest: new onset of Guillain Barre Syndrome (GBS), Bell's Palsy, encephalitis or myelitis, optic neuritis, Stevens Johnson Syndrome, and toxic epidermal necrolysis|Day 0 before vaccination to Day 180 after vaccination|Adverse events of special interest were assessed in all participants who received study vaccine (Full Analysis Set).||Participants|||Number
801553|NCT00976027|Other Pre-specified|Number of Participants Reporting Events Associated With All Cases of CDC Defined Influenza-Like Illness (ILI)|Events associated with CDC defined influenza-like Illnesses (ILI) were defined as pneumonia, new onset or exacerbation of pre existing cardio respiratory conditions, health care visits, and medication use (including nonsteroidal anti-inflammatory drugs, NSAIDs).|Day 14 (post-vaccination) up to 12 Months post-vaccination|The occurrence of events associated with CDC defined ILI was assessed in all participants who met all study inclusion and exclusion criteria, received the vaccine to which they were randomized, and had no protocol violations that might have interfered with evaluation of primary endpoints (Per-Protocol Analysis Set).||Participants|||Number
801554|NCT00976027|Other Pre-specified|Number of Participants Reporting Events Associated With All Cases of Protocol Defined Influenza-Like Illness (ILI)|Events associated with Protocol defined influenza-like Illnesses (ILI) were defined as pneumonia, new onset or exacerbation of pre-existing cardio respiratory conditions, health care visits, and medication use (including nonsteroidal anti-inflammatory drugs, NSAIDs).|Day 0 (pre-vaccination) up to the end of the influenza season|The occurrence of events associated with ILI was assessed in all participants who met all study inclusion and exclusion criteria, received the vaccine to which they were randomized, and had no protocol violations that might have interfered with evaluation of primary endpoints (Per-Protocol Analysis Set).||Participants|||Number
801555|NCT00976027|Primary|Efficacy of Fluzone High Dose Relative to Fluzone in the Prevention of Laboratory Confirmed Influenza Caused by Viral Types and Subtypes That Are Antigenically Similar to Those Contained in the Respective Annual Vaccine Formulations.|The presence (and specific identification) of influenza virus in the respiratory tract of vaccinated individuals with influenza like illness (ILI) was confirmed by tissue culture (for infectious virus) and molecular techniques (polymerase chain reaction based assays), with results reported for cases cause by any viral type or subtype.|Day 0 (pre-vaccination) up to Year 1 post-vaccination|Efficacy was assessed in all participants who met all study inclusion criteria and none of the exclusion criteria, received the vaccine to which they were randomized, and had no protocol violations that might have interfered with evaluation of primary endpoints (Per Protocol Analysis Set).||Participants|||Number
801556|NCT00976183|Secondary|Number of Participants With Progression Free Survival (PFS) up to 24 Months|Progression-free survival was defined as the length of time from the date of initial induction chemotherapy until clinical, radiological, or CA-125 progression|2 years or 24 months|||participants|||Number
801557|NCT00976183|Primary|Objective Response Rate|Clinical response was assessed by clinical, serologic, and radiographic means.|2 years or 24 months|Response Evaluation Criteria In Solid Tumors (RECIST v1.0)||participants|||Number
801558|NCT00976209|Secondary|Percentage of Participants That Preferred the Convenience of Phenylephrine HCl 30 mg Extended Release Tablets, as Compared to Phenylephrine HCl 10 mg Immediate Release Tablets|"Convenience was calculated based on total participants that completed the study.
Responses to the following questions in the consumer preference questionnaire were the basis for the preference endpoints:
Secondary Endpoint
Which product, if any, was more convenient?
The possible answers were:
I preferred the convenience of Treatment A (the every 12 hours white tablet; Phenylephrine HCl 30 mg Extended Release Tablet)
I preferred the convenience of Treatment B (the every 4 hours red tablet; Phenylephrine HCl 10 mg Immediate Release tablet)
or
• I did not have a preference"|Visit 6 (Period 2, Day 4)|A total of 319 of 331 subjects who completed both treatment periods provided a response to the primary endpoint, and hence were included in the Modified Intent-to-Treat (MITT) population.||Percentage of participants|||Number
801559|NCT00976209|Primary|Percentage of Participants That Preferred Phenylephrine HCl 30 mg Extended Release Tablets, as Compared to Phenylephrine HCl 10 mg Immediate Release Tablets for the Relief of Nasal Congestion|"Preference was calculated based on total participants that completed the study.
Responses to the following questions in the consumer preference questionnaire were the basis for the preference endpoints:
Which product, if any, did you prefer for the relief of nasal congestion?
The possible answers were:
I preferred the relief of Treatment A (the every 12 hours white tablet; Phenylephrine HCl 30 mg Extended Release Tablet)
I preferred the relief of Treatment B (the every 4 hours red tablet; Phenylephrine HCl 10 mg Immediate Release tablet)
or
• I did not have a preference"|Visit 6 (Period 2, Day 4)|A total of 319 of 331 subjects who completed both treatment periods provided a response to the primary endpoint, and hence were included in the Modified Intent-to-Treat (MITT) population.||Percentage of participants|||Number
811713|NCT01059760|Primary|Change From Baseline in Participant White Blood Cell Count (WBC) When Fasting and Fed||Baseline and 3 days|||cells/mL||Standard Deviation|Mean
801563|NCT00976274|Secondary|Change in the Pre- and Post-treatment Oxidized Low-densty Lipoprotein(LDL)||baseline and 12 weeks|||uIU/mL||Standard Deviation|Mean
801564|NCT00976274|Primary|Change in the Pre- and Post-treatment Systolic Blood Pressure||baseline and 12 weeks|||mm Hg||Standard Deviation|Mean
801565|NCT00976339|Secondary|Change in Mammographic Breast Density||1 year|Data for this study (NCT00976339) is combined with the data for another study (NCT00859651); see NCT00859651 for combined results. Investigator is unable to determine the subject data that should be entered for this study alone, since subject data was combined for the purpose of data analysis. Data for this study alone was not analyzed.|||||
801566|NCT00976339|Primary|Number of Participants That Successfully Completed the 1-year Intervention||1 year|Data for this study (NCT00976339) is combined with the data for another study (NCT00859651); see NCT00859651 for combined results. Investigator is unable to determine the subject data that should be entered for this study alone, since subject data was combined for the purpose of data analysis. Data for this study alone was not analyzed.|||||
801567|NCT00976391|Secondary|Change From Baseline in Body Weight at Weeks 36, 48 and 52|The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. This analysis used observed body weight values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|Baseline and Weeks 36, 48 and 52|ITT Population with observed values. Only those participants who were available at the indicated time points were analyzed (represented by n=X, X in the category title).||Kilograms||Standard Deviation|Mean
801568|NCT00976391|Secondary|Change From Baseline in Body Weight at Week 26|The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The LOCF method was used to impute missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue were treated as missing and replaced with prerescue values. Based on ANCOVA: change = treatment + Baseline weight + Baseline HbA1c category + prior myocardial infarction history + age category + region + current oral antidiabetic therapy.|Baseline and Week 26|ITT Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 26.||Kilograms||Standard Error|Least Squares Mean
801569|NCT00976391|Secondary|Time to Hyperglycemia Rescue|Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue. The conditions for hyperglycemia rescue were as follows: HbA1c >9.0% and <0.5% decrease from Baseline between >=Week 4 and <Week 8; HbA1c >9.0% and <0.5% decrease from Baseline between >=Week 8 and <Week 12; HbA1c >8.5% and >=4 weeks since uptitration between >=Week 12 and <Week 16; HbA1c >8.0% and >=4 weeks since uptitration; HbA1c >7.5% and >=4 weeks between >Week 26 and >=Week 48 since uptitration. Participants could have been rescued at any time after Week 4. Time to hyperglycemia rescue is the time between the date of first dose and the date of hyperglycemia rescue plus 1 day, or the time between the date of first dose and the date of last visit during active treatment period plus 1 day for participants not requiring rescue. This time is divided by 7 to express the result in weeks.|From the start of study medication until the end of the treatment (up to Week 52)|ITT Population. Only those participants with a value at Baseline and at the specified visit were analyzed.||Weeks||95% Confidence Interval|Median
801570|NCT00976391|Secondary|Number of Participants Who Achieved HbA1c Response Level of <6.5% and <7.0% at Week 26|The number of participants who acheieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5% and <7.0% at Week 26) were assessed.|Week 26|ITT Population. Only those participants available at the indicated time point were assessed.||Participants|||Number
801571|NCT00976391|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 36, 48 and 52|The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline FPG minus the Baseline FPG. This analysis used observed FPG values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|Baseline and Weeks 36, 48 and 52|ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed (represented by n=X, X in the category title).||Millimoles per liter (mmol/L)||Standard Deviation|Mean
801572|NCT00976391|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26|The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. The LOCF method was used to impute missing post-Baseline FPG values. FPG values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on ANCOVA: change = treatment + Baseline FPG + Baseline HbA1c category + region|Baseline and Week 26|Intent-to-Treat (ITT) Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 26.||Millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
801621|NCT00976599|Primary|Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 24 Hours Post-dose on Day 28|Serum samples were analyzed for IL-1ra and IL-15 concentrations using a validated, sensitive and specific ELISA method.|24 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||pg/mL||Standard Deviation|Mean
801573|NCT00976391|Secondary|Change From Baseline in HbA1c at Weeks 36, 48 and 52|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. Baseline is defined as the last available assessment on or prior to the first dose of study drug. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed HbA1c values, excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|Baseline and Weeks 36, 48 and 52|ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Percentage of HbA1c in the blood||Standard Deviation|Mean
801574|NCT00976391|Primary|Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 26|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The BL HbA1c value is defined as the last non-missing value before the start of treatment. Change from BL was calculated as the value at Week 26 minus the value at BL. The analysis was performed using an Analysis of Covariance (ANCOVA) model with treatment group, region, history of prior myocardial infarction (yes versus no), and age category (<65 years versus ≥65 years) as factors and Baseline HbA1c as a continuous covariate.The last observation carried forward (LOCF) method was used to impute missing post-BL HbA1c values; the last non-missing post-BL on-treatment measurement was used to impute the missing measurement. HbA1c values obtained after hyperglycemic rescue were treated as missing and were replaced with pre-rescue values.|Baseline and Week 26|Intent-to-Treat (ITT) Population with LOCF: all randomized par. who received >=1 dose of study medication and who had a BL assessment and >=1 post-BL assessment of HbA1c. Only par. with a value at BL and at the specified visit were analyzed. Values were carried forward for par. who were rescued or discontinued from active treatment before Week 26.||Percentage of HbA1c in the blood||Standard Error|Least Squares Mean
801575|NCT00976404|Secondary|Serious Adverse Events Attributed to Study Treatments|Grade 3 or 4 serious adverse events related to study treatments (raltegravir, maraviroc, or HIV-recombinant Ad5-based vaccine)|56 weeks|||serious adverse events|||Number
801576|NCT00976404|Secondary|HIV Specific T-cell Response to Env|HIV-specific immunity: Interferon gamma ELISpot response to Env (clades A) at week 36 (one month after rAd5 boosting)|36 weeks|||response per 10^6 PBMCs||Standard Deviation|Median
801577|NCT00976404|Secondary|Change From Baseline in CD4+ T Cell Count at Week 56||Week 56|||cells per mm^3||Inter-Quartile Range|Median
801578|NCT00976404|Secondary|Change From Baseline in HIV DNA in Rectal Tissue at Week 56||Week 56|||log^10 copies per 10^6 cells||Inter-Quartile Range|Median
801579|NCT00976404|Primary|Change From Baseline in HIV DNA in PBMCs at Week 56||56 weeks|||log^10 copies per 10^6 PBMCs||Inter-Quartile Range|Median
801580|NCT00976456|Secondary|Overall Survival|Overall survival (defined as the number of days from the day of first treatment to death (from any cause), or until the last day if we know that the patient is alive).|42 months|||months||95% Confidence Interval|Median
801581|NCT00976456|Primary|Progression Free Survival|Progression free survival (defined as the number of days from the day of the first treatment until day of death (from any cause) or progression, whichever occurs earlier, or until the day of the last response assessment, if no progression or death (from any cause) is observed during the study).|42 months|||months||95% Confidence Interval|Median
801582|NCT00976482|Primary|Two-year All-cause Mortality||2 years|||percentage of participants||95% Confidence Interval|Number
801583|NCT00976495|Secondary|Adjusted Mean Change From Baseline in Nighttime (0100 to 0600 Hours) Ambulatory Systolic Blood Pressure (ASBP) at Week 12 (Last Observation Carried Forward [LOCF])|Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Measurements were obtained during lead-in, and Week 12 in the double-blind period.|From Baseline to Week 12|All randomized participants who received study medication and had nonmissing ASBP values at baseline and Week 12 (LOCF)||mmHg||Standard Error|Mean
801584|NCT00976495|Secondary|Adjusted Mean Change From Baseline in Daytime (0900 to 2100 Hours) Ambulatory Systolic Blood Pressure (ASBP) at Week 12 (Last Observation Carried Forward [LOCF])|Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Measurements were obtained during lead-in, and Week 12 in the double-blind period.|From Baseline to Week 12|All randomized participants who received study medication and had nonmissing ASBP values at baseline and Week 12 (LOCF)||mmHg||Standard Error|Mean
801585|NCT00976495|Secondary|Adjusted Mean Change From Baseline in 24-Hour Ambulatory Systolic Blood Pressure (ASBP) at Week 12 (Last Observation Carried Forward [LOCF])|Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Measurements were obtained during lead-in, and Week 12 in the double-blind period.|From Baseline to Week 12|All randomized participants who received study medication and had nonmissing ASBP values at baseline and Week 12 (LOCF)||mmHg||Standard Error|Mean
801586|NCT00976495|Primary|Adjusted Percent Change From Baseline in Glomerular Filtration Rate (GFR) at Week 12 (Modified Last Observation Carried Forward [MLOCF])|Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. If no Week 12 measurement was available, the last available post-baseline measurement obtained on or after Day 23 was used regardless of rescue medication. Measurements were obtained during radomization visit, and Week 12 in the double-blind period by a central laboratory.|From Baseline to Week 12|All randomized participants who received study medication and had nonmissing HbA1c values at baseline and Week 12 (MLOCF)||% Change of Baseline GFR||Standard Error|Mean
801587|NCT00976508|Secondary|Number of Participants With Objective Response|Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST)version 1.1. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST version 1.1. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.|From Screening, odd numbered cycles (predose, Cycle 3, 5, 7 etc.) up to Cycle 27 or end of treatment visit (21 days after last dose of figitumumab)|Response-evaluable set: All participants who started Cycle 1 with an adequate baseline tumor assessment and at least 1 follow up tumor assessment.||participants|||Number
801588|NCT00976508|Secondary|Percentage of Participants Reporting Positive Anti-Drug Antibodies (ADA) Response for Figitumumab|Percentage of participants with positive total or neutralizing ADA for figitumumab.|Day 1 of Cycles 1 and 4; end of treatment (21 days after last dose of figitumumab); follow-up visit (90 days after last dose of figitumumab)|ADA samples were not analyzed as the study was terminated prematurely due to lack of operational feasibility and the halt of figitumumab development.|||||
801589|NCT00976508|Secondary|Mean Change in Glucose Levels Between Fasting and Post Glucose Load|The effect of combining figitumumab with pegvisomant was analyzed to assess whether pegvisomant reverses figitumumab-induced glucose intolerance at various pegvisomant dose levels. The change in glucose load was assessed by Glucose Tolerance Testing (GTT) at baseline (fasting), during Cycle 1 following administration of figitumumab alone (post load), and near the end of Cycle 2 (post load) following combined therapy with figitumumab and pegvisomant.|Screening; Day 8 of Cycle 1; Day 15 of Cycle 2|Glucose tolerance set: All enrolled participants who started treatment and who had at least one baseline or on-study sample submitted. N=number of participants with analyable data for this outcome measure.||milligram/deciliter (mg/dL)||Standard Deviation|Mean
801590|NCT00976508|Secondary|Area Under the Trough Concentrations (AUCtrough)|The trough concentration-time profile (AUCtrough) of pegvisomant was to be analyzed by noncompartmental methods.|Cycle 1: Day 15 (within 2 hours before loading dose), Day 16 (within 2 hours pre-SC dose); Cycle 2: Days 1, 8 and 15 (within 2 hours pre-SC dose); Cycle 3 up to Cycle 17: Day 1 (within 2 hours pre-SC dose); end of treatment; 90-day follow-up visit|PK samples were not analyzed as the study was terminated prematurely due to lack of operational feasibility and the halt of figitumumab development.|||||
801591|NCT00976508|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)of Figitumumab|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)of figitumumab after Cycle 1|Cycle 2: Day 1 (within 2 hours before and 1 hour after figitumumab infusion); Cycle 3 to Cycle 17: Day 1 (within 2 hours before figitumumab infusion); end of treatment; 90-day follow-up visit|PK samples were not analyzed as the study was terminated prematurely due to lack of operational feasibility and the halt of figitumumab development.|||||
801592|NCT00976508|Secondary|Cycle 1: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Figitumumab|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) of figitumumab in cycle 1.|Days 1, 2, 8 and 15 of Cycle 1; Day 1 of subsequent cycle starting from Cycle 2 (up to Cycle 17); end of treatment ( 21 days after last dose of figitumumab); follow-up visit (90 days after last dose of figitumumab)|PK samples were not analyzed as the study was terminated prematurely due to lack of operational feasibility and the halt of figitumumab development.|||||
801593|NCT00976508|Secondary|Plasma Concentration at the Last Quantifiable Time Point (Clast) of Figitumumab|Plasma Concentration at the Last Quantifiable Time Point (Clast) of Figitumumab from Cycle 2 to the end of treatment.|Cycle 2: Day 1 (within 2 hours before and 1 hour after figitumumab infusion); Cycle 3 to Cycle 17: Day 1 (within 2 hours before figitumumab infusion); end of treatment; 90-day follow-up visit|PK samples were not analyzed as the study was terminated prematurely due to lack of operational feasibility and the halt of figitumumab development.|||||
801594|NCT00976508|Secondary|Cycle 1: Plasma Concentration at the Last Quantifiable Time Point (Clast) of Figitumumab||Cycle 1: Day 1 (within 2 hours before figitumumab infusion), Day 2 (1 hour post figitumumab infusion), Day 8 and Day 15|PK samples were not analyzed as the study was terminated prematurely due to lack of operational feasibility and the halt of figitumumab development.|||||
801595|NCT00976508|Secondary|Maximum Observed Plasma Concentration (Cmax) of Figitumumab||Cycle 2: Day 1 (within 2 hours before and 1 hour after figitumumab infusion); Cycle 3 to Cycle 17: Day 1 (within 2 hours before figitumumab infusion); end of treatment; 90-day follow-up visit|PK samples were not analyzed as the study was terminated prematurely due to lack of operational feasibility and the halt of figitumumab development.|||||
801596|NCT00976508|Secondary|Cycle 1: Maximum Observed Plasma Concentration (Cmax) of Figitumumab||Cycle 1: Day 1 (within 2 hours before figitumumab infusion), Day 2 (1 hour post figitumumab infusion), Day 8 and Day 15|PK samples were not analyzed as the study was terminated prematurely due to lack of operational feasibility and the halt of figitumumab development.|||||
801597|NCT00976508|Secondary|Serum Circulating Insulin-like Growth Factor (IGF-1) Levels|The effect of the combined therapy with figitumumab and pegvisomant on circulating concentrations of total IGF-1 was assessed.|Days 1 and 15 of Cycle 1 (Baseline); Day 1 of subsequent cycles starting from Cycle 2 to Cycle 27; end of treatment (21 days after last dose of figitumumab); follow-up visit (90 days after last dose of figitumumab)|Biomarker analysis set: all enrolled participants who had at least 1 baseline or on-study sample submitted. N=number of participants who were evaluable for IGF-1 Levels at prespecified time points.||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
801598|NCT00976508|Primary|Number of Participants With Dose Limiting Toxicities (DLT)|DLT was defined as any of the following events occurring during DLT period and considered related to study medication: Grade (Gr) 4 neutropenia lasting >=7 days, febrile neutropenia (Gr 3 or 4 neutropenia, fever >=38.5 degrees Celsius, lasting over 24 hours), neutropenic infection (Gr >=3 neutropenia, infection); Gr 3 or 4 thrombocytopenia associated with bleeding or Gr 4 thrombocytopenia >=7 days; Gr 3 or 4 lymphopeniab accompanied by an opportunistic infection; other non-hematologic Grade 4 toxicities or symptomatic Gr 3 toxicities that require medical intervention and 14 days to resolve.|From Cycle 2, Day 1 to Cycle 3, Day 8; from Cycle 1, Day 15 to end of Cycle 2|Safety analysis set: all enrolled participants who received at least 1 dose of either of the study medications. N=number of participants remained on treatment throughout the required DLT period and included as analyzed for DLT based on the defined DLT evaluability specifications.||participants|||Number
801599|NCT00976508|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. AEs were graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 (Grade [Gr] 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death). Relatedness to [study drug] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.|From Screening to the follow-up visit (90 days after last dose of figitimumab)|Safety analysis set: all enrolled participants who received at least 1 dose of either of the study medications.||Participants|||Number
801600|NCT00976521|Secondary|Major Secondary Endpoint - Infarct Size at 30 Days as a Percentage of Total Left Ventricular Mass - Aspiration vs. No Aspiration|The major secondary endpoint of the INFUSE AMI Study is infarct size as a percentage of total myocardial mass at 30 days measured by cardiac MRI (cMRI), comparing the pooled randomized aspiration arms to the pooled no aspiration arms, without regard to abciximab infusion.|30 Days|Evaluable cardiac MRI (cMRI) results at 30 days to assess percentage of total myocardial mass were available for 192 and 190 patients randomized to thrombus aspiration versus no no thrombus aspiration, respectively for the ITT (intention to treat) analysis set.||Percentage of Total Myocardial Mass||Inter-Quartile Range|Median
801601|NCT00976521|Primary|Primary Endpoint - Infarct Size at 30 Days as a Percentage of Total Left Ventricular Mass - Abciximab Infusion vs. No Infusion|The primary endpoint of the INFUSE AMI study is infarct size as a percentage of total left ventricular mass at 30 days as measured by cardiac MRI (cMRI), comparing the pooled randomized active (abciximab) infusion to the pooled non infusion arms, without regard to aspiration.|30 Days Post Index Procedure|Evaluable cardiac MRI (cMRI) results at 30 days to assess percentage of total left ventricular mass were available for 181 and 172 patients randomized to intracoronary abciximab infusion versus no abciximab infusion, respectively for the ITT (intention to treat) analysis set.||Percentage of Left Ventricular Mass||Inter-Quartile Range|Median
801602|NCT00976573|Secondary|Overall Survival Time|Overall survival time is defined as the time from registration to death due to any cause. The distribution of survival times will be estimated using the method of Kaplan-Meier.|up to 5 years|Intent-to-treat analysis population: All participants enrolled are included.||months||95% Confidence Interval|Median
801603|NCT00976573|Secondary|Confirmed Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) According to Response Evaluation Criteria in Solid Tumors (RECIST) Criteria|Confirmed Tumor Response: A confirmed tumor response is defined to be a CR or PR (by the RECIST criteria) noted as the objective status on 2 consecutive evaluations at least 8 weeks apart. The proportion of tumor responses will be estimated by the number of confirmed tumor responses divided by the total number of evaluable patients. A ninety percent confidence interval for the true proportion of confirmed tumor responses will be calculated assuming that the number of confirmed tumor responses follows a binomial distribution.|Up to 5 years|Intent-to-treat analysis population: All participants enrolled are included.||percentage of patients||95% Confidence Interval|Number
801604|NCT00976573|Secondary|Toxicity|For this secondary endpoint, toxicity is defined as a grade 3 or higher adverse events that is classified as either possibly, probably, or definitely related to study treatment. The assignment of attribution to study treatment and grade (or degree of severity) of the adverse event are classified using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The percentage of participants reporting a grade 3 or higher toxicity is reported. For a list of all reported adverse events, please refer to the Adverse Events Section below.|Up to 5 years|Participants who completed the study (specified in the Participant Flow) are included.||percentage of participants|||Number
801605|NCT00976573|Primary|Progression-free Survival|The primary endpoint is progression-free survival (PFS) defined as the time from randomization to documentation of disease progression or death without documentation of progression. The distribution of PFS times will be estimated using the Kaplan-Meier method. Progression is defined using the RECIST Criteria as at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum of diameters recorded on study (this includes the baseline sum if that is the smallest on study) or the appearance of one or more new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm of target lesions, or the appearance of one or more new lesions, unequivocal progression of existing non-target lesions, although unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.|Time from randomization to documentation of disease progression or death without documentation of progression;Up to 5 years|Intent-to-treat analysis population: All participants enrolled are included in the primary analysis.||months||95% Confidence Interval|Median
801606|NCT00976599|Secondary|Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) <=3.2 and <2.6|DAS28-4 (ESR) was calculated from the number of SJC, TJC using the 28 joints count, ESR [mm/hour] and patient's global assessment (PtGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity, > 3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Day -7, 1 (Baseline), 28, 35 or Early Termination|FAS included all randomized participants who received at least 1 dose of the study medication.||percentage of participants|||Number
801607|NCT00976599|Secondary|Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Day 28 and 35|DAS28-4 (ESR) was calculated from the number of SJC, TJC using the 28 joints count, ESR [mm/hour] and patient's global assessment (PtGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity, > 3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Day 1 (Baseline), 28, 35 or Early Termination|FAS included all randomized participants who received at least 1 dose of the study medication.||units on a scale||Standard Deviation|Mean
801701|NCT00976703|Secondary|Time to Foley Expulsion|time from Foley placement until it is spontaneously expulsed from the cervix|an average of 2 hours, up to 12 hours|||hours||Full Range|Median
801608|NCT00976599|Secondary|Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])|DAS28-4 (ESR) was calculated from the number of SJC, TJC using the 28 joints count, ESR (millimeters per hour [mm/hour]) and patient's global assessment (PtGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity, > 3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Day -7, 1 (Baseline), 28, 35 or Early Termination|FAS included all randomized participants who received at least 1 dose of the study medication.||units on a scale||Standard Deviation|Mean
801609|NCT00976599|Secondary|Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) <=3.2 and <2.6|DAS28-3 (CRP) was calculated from the SJC, TJC using the 28 joints count and the CRP (mg/mL). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) <= 3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Day -7, 1 (Baseline), 28, 35 or Early Termination|FAS included all randomized participants who received at least 1 dose of the study medication.||percentage of participants|||Number
801610|NCT00976599|Secondary|Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Day 28 and 35|DAS28-3 (CRP) was calculated from the SJC, TJC using the 28 joints count and the CRP (mg/mL). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) <= 3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Day 1 (Baseline), 28, 35 or Early Termination|FAS included all randomized participants who received at least 1 dose of the study medication.||units on a scale||Standard Deviation|Mean
801611|NCT00976599|Secondary|Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])|DAS28-3 (CRP) was calculated from the SJC, TJC using the 28 joints count and the CRP) (milligram per liter [mg/L]). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) less than or equal to (<=) 3.2 implied low disease activity, greater than (>) 3.2 to 5.1 implied moderate to high disease activity and less than (<) 2.6 implied remission.|Day -7, 1 (Baseline), 28, 35 or Early Termination|FAS included all randomized participants who received at least 1 dose of the study medication.||units on a scale||Standard Deviation|Mean
801612|NCT00976599|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response|ACR70 response: >=70% improvement in TJC; >= 70% improvement in SJC; and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Day 28, 35 or Early Termination|FAS included all randomized participants who received at least 1 dose of the study medication.||percentage of participants|||Number
801613|NCT00976599|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response|ACR50 response: >=50% improvement in TJC; >= 50% improvement in SJC; and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Day 28, 35 or Early Termination|FAS included all randomized participants who received at least 1 dose of the study medication.||percentage of participants|||Number
801614|NCT00976599|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% Response|ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count (TJC); >= 20% improvement in swollen joint count (SJC); and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Day 28, 35 or Early Termination|FAS included all randomized participants who received at least 1 dose of the study medication.||percentage of participants|||Number
801615|NCT00976599|Primary|Urine Collagen Type II C-telopeptide Fragments (uCTX-II) at Pre-dose on Day 35 or Early Termination|Urinary concentration of collagen type II C-telopeptide fragments was measured by competitive ELISA. uCTX-II was measured as ng/mmol Cr.|Pre-dose on Day 35 or Early Termination|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||ng/mmol Cr||Standard Deviation|Mean
801616|NCT00976599|Primary|Urine Collagen Type II C-telopeptide Fragments (uCTX-II) at 24 Hours Post-dose on Day 28|Urinary concentration of collagen type II C-telopeptide fragments was measured by competitive ELISA. uCTX-II was measured as ng/mmol Cr.|24 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||ng/mmol Cr||Standard Deviation|Mean
801617|NCT00976599|Primary|Urine Collagen Type II C-telopeptide Fragments (uCTX-II) at Pre-dose on Day 28|Urinary concentration of collagen type II C-telopeptide fragments was measured by competitive ELISA. uCTX-II was measured as ng/mmol Cr.|Pre-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication.||ng/mmol Cr||Standard Deviation|Mean
801618|NCT00976599|Primary|Urine Collagen Type II C-telopeptide Fragments (uCTX-II) at Pre-dose on Day 10|Urinary concentration of collagen type II C-telopeptide fragments was measured by competitive ELISA. uCTX-II was measured as ng/mmol Cr.|Pre-dose on Day 10|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||ng/mmol Cr||Standard Deviation|Mean
801619|NCT00976599|Primary|Urine Collagen Type II C-telopeptide Fragments (uCTX-II) at Pre-dose on Day 1|Urinary concentration of collagen type II C-telopeptide fragments was measured by competitive ELISA. uCTX-II was measured as nanogram per millimoles of creatinine (ng/mmol Cr).|Pre-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||ng/mmol Cr||Standard Deviation|Mean
802983|NCT00988442|Secondary|Change in CD4 Cell Count at Week 48|Change in CD4 cell count from baseline at Week 48, calculated as Week 48 CD4 minus baseline CD4.|Baseline and Week 48|Only 16 participants had week 48 CD4 observations to be included in this analysis.||cells/mm^3||95% Confidence Interval|Mean
801622|NCT00976599|Primary|Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 8 Hours Post-dose on Day 28|Serum samples were analyzed for IL-1ra and IL-15 concentrations using a validated, sensitive and specific ELISA method.|8 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable for this measure at specified time points for each arm group, respectively.||pg/mL||Standard Deviation|Mean
801623|NCT00976599|Primary|Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 4 Hours Post-dose on Day 28|Serum samples were analyzed for IL-1ra and IL-15 concentrations using a validated, sensitive and specific ELISA method.|4 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable for this measure at specified time points for each arm group, respectively.||pg/mL||Standard Deviation|Mean
801624|NCT00976599|Primary|Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 1 Hour Post-dose on Day 28|Serum samples were analyzed for IL-1ra and IL-15 concentrations using a validated, sensitive and specific ELISA method.|1 Hour Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||pg/mL||Standard Deviation|Mean
801625|NCT00976599|Primary|Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at Pre-dose on Day 28|Serum samples were analyzed for IL-1ra and IL-15 concentrations using a validated, sensitive and specific ELISA method.|Pre-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||pg/mL||Standard Deviation|Mean
801626|NCT00976599|Primary|Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at Pre-dose on Day 10|Serum samples were analyzed for IL-1ra and IL-15 concentrations using a validated, sensitive and specific ELISA method.|Pre-dose on Day 10|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||pg/mL||Standard Deviation|Mean
801627|NCT00976599|Primary|Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 4 Hours Post-dose on Day 1|Serum samples were analyzed for IL-1ra and IL-15 concentrations using a validated, sensitive and specific ELISA method.|4 Hours Post-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||pg/mL||Standard Deviation|Mean
801628|NCT00976599|Primary|Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 1 Hour Post-dose on Day 1|Serum samples were analyzed for IL-1ra and IL-15 concentrations using a validated, sensitive and specific ELISA method.|1 Hour Post-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||pg/mL||Standard Deviation|Mean
801629|NCT00976599|Primary|Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at Pre-dose on Day 1|Serum samples were analyzed for IL-1ra and IL-15 concentrations using a validated, sensitive and specific ELISA method.|Pre-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||pg/mL||Standard Deviation|Mean
801630|NCT00976599|Primary|Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at Pre-dose on Day 35 or Early Termination|Serum samples were analyzed for SAA concentrations using MSD single ELISA electrochemiluminescence method and for CTX-1 concentrations using a validated, sensitive and specific ECLIA.|Pre-dose on Day 35 or Early Termination|FAS included all randomized participants who received at least 1 dose of the study medication.||ng/mL||Standard Deviation|Mean
801631|NCT00976599|Primary|Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 24 Hours Post-dose on Day 28|Serum samples were analyzed for SAA concentrations using MSD single ELISA electrochemiluminescence method and for CTX-1 concentrations using a validated, sensitive and specific ECLIA.|24 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||ng/mL||Standard Deviation|Mean
801632|NCT00976599|Primary|Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 8 Hours Post-dose on Day 28|Serum samples were analyzed for SAA concentrations using MSD single ELISA electrochemiluminescence method and for CTX-1 concentrations using a validated, sensitive and specific ECLIA.|8 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable for this measure at specified time points for each arm group, respectively.||ng/mL||Standard Deviation|Mean
801633|NCT00976599|Primary|Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 4 Hours Post-dose on Day 28|Serum samples were analyzed for SAA concentrations using MSD single ELISA electrochemiluminescence method and for CTX-1 concentrations using a validated, sensitive and specific ECLIA.|4 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||ng/mL||Standard Deviation|Mean
801634|NCT00976599|Primary|Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 1 Hour Post-dose on Day 28|Serum samples were analyzed for SAA concentrations using MSD single ELISA electrochemiluminescence method and for CTX-1 concentrations using a validated, sensitive and specific ECLIA.|1 Hour Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||ng/mL||Standard Deviation|Mean
801635|NCT00976599|Primary|Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at Pre-dose on Day 28|Serum samples were analyzed for SAA concentrations using MSD single ELISA electrochemiluminescence method and for CTX-1 concentrations using a validated, sensitive and specific ECLIA.|Pre-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication.||ng/mL||Standard Deviation|Mean
801636|NCT00976599|Primary|Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at Pre-dose on Day 10|Serum samples were analyzed for SAA concentrations using MSD single ELISA electrochemiluminescence method and for CTX-1 concentrations using a validated, sensitive and specific ECLIA.|Pre-dose on Day 10|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||ng/mL||Standard Deviation|Mean
801637|NCT00976599|Primary|Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 4 Hours Post-dose on Day 1|Serum samples were analyzed for SAA concentrations using MSD single ELISA electrochemiluminescence method and for CTX-1 concentrations using a validated, sensitive and specific ECLIA.|4 Hours Post-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||ng/mL||Standard Deviation|Mean
801638|NCT00976599|Primary|Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 1 Hour Post-dose on Day 1|Serum samples were analyzed for SAA concentrations using MSD single ELISA electrochemiluminescence method and for CTX-1 concentrations using a validated, sensitive and specific ECLIA.|1 Hour Post-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||ng/mL||Standard Deviation|Mean
801639|NCT00976599|Primary|Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at Pre-dose on Day 1|Serum samples were analyzed for SAA concentrations using meso scale discovery (MSD) single ELISA electrochemiluminescence method and for CTX-1 concentrations using a validated, sensitive and specific Electro ChemiLuminescent ImmunoAssay (ECLIA).|Pre-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable for this measure at specified time points for each arm group, respectively.||ng/mL||Standard Deviation|Mean
801640|NCT00976599|Primary|Plasma Level of Interleukin-34 (IL-34) and Interleukin-18 (IL-18)||Pre-dose on Day 1, 10, 28 and 35 or Early Termination; 1, 4 hours Post-dose on Day 1, 28; 8, 24 hours Post-dose on Day 28|Analyses of IL-34 and IL-18 were not performed as a valid assay was not available.|||||
801641|NCT00976599|Primary|Plasma Level of Matrix Metallopeptidase (MMP13)||Pre-dose on Day 1, 10, 28 and 35 or Early Termination; 1, 4 hours Post-dose on Day 1, 28; 8, 24 hours Post-dose on Day 28|Analyses of MMP13 was not performed as valid assay for MMP13 was not available.|||||
801642|NCT00976599|Primary|Osteoprotegerin(OPG) Level at Pre-dose on Day 35 or Early Termination|Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.|Pre-dose on Day 35 or Early Termination|FAS included all randomized participants who received at least 1 dose of the study medication.||pmol/L||Standard Deviation|Mean
801643|NCT00976599|Primary|Osteoprotegerin (OPG) Level at 24 Hours Post-dose on Day 28|Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.|24 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||pmol/L||Standard Deviation|Mean
801644|NCT00976599|Primary|Osteoprotegerin (OPG) Level at 8 Hours Post-dose on Day 28|Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.|8 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||pmol/L||Standard Deviation|Mean
801645|NCT00976599|Primary|Osteoprotegerin (OPG) Level at 4 Hours Post-dose on Day 28|Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.|4 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||pmol/L||Standard Deviation|Mean
801646|NCT00976599|Primary|Osteoprotegerin (OPG) Level at 1 Hour Post-dose on Day 28|Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.|1 Hour Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication.||pmol/L||Standard Deviation|Mean
801647|NCT00976599|Primary|Osteoprotegerin (OPG) Level at Pre-dose on Day 28|Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.|Pre-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication.||pmol/L||Standard Deviation|Mean
801648|NCT00976599|Primary|Osteoprotegerin (OPG) Level at Pre-dose on Day 10|Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.|Pre-dose on Day 10|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||pmol/L||Standard Deviation|Mean
801649|NCT00976599|Primary|Osteoprotegerin (OPG) Level at 4 Hours Post-dose on Day 1|Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.|4 Hours Post-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||picomole per liter (pmol/L)||Standard Deviation|Mean
801650|NCT00976599|Primary|Osteoprotegerin (OPG) Level at 1 Hour Post-dose on Day 1|Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.|1 Hour Post-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication.||pmol/L||Standard Deviation|Mean
801651|NCT00976599|Primary|Osteoprotegerin (OPG) Level at Pre-dose on Day 1|Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.|Pre-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication.||picomole per liter (pmol/L)||Standard Deviation|Mean
801652|NCT00976599|Primary|Parathyroid Hormone (PTH) Level at Pre-dose on Day 35 or Early Termination|Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.|Pre-dose on Day 35 or Early Termination|FAS included all randomized participants who received at least 1 dose of the study medication.||pg/mL||Standard Deviation|Mean
801653|NCT00976599|Primary|Parathyroid Hormone (PTH) Level at 24 Hours Post-dose on Day 28|Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.|24 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||pg/mL||Standard Deviation|Mean
801654|NCT00976599|Primary|Parathyroid Hormone (PTH) Level at 8 Hours Post-dose on Day 28|Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.|8 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||pg/mL||Standard Deviation|Mean
801655|NCT00976599|Primary|Parathyroid Hormone (PTH) Level at 4 Hours Post-dose on Day 28|Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.|4 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||pg/mL||Standard Deviation|Mean
801656|NCT00976599|Primary|Parathyroid Hormone (PTH) Level at 1 Hour Post-dose on Day 28|Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.|1 Hour Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication.||pg/mL||Standard Deviation|Mean
801657|NCT00976599|Primary|Parathyroid Hormone (PTH) Level at Pre-dose on Day 28|Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.|Pre-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||pg/mL||Standard Deviation|Mean
801658|NCT00976599|Primary|Parathyroid Hormone (PTH) Level at Pre-dose on Day 10|Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.|Pre-dose on Day 10|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||pg/mL||Standard Deviation|Mean
801659|NCT00976599|Primary|Parathyroid Hormone (PTH) Level at 4 Hours Post-dose on Day 1|Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.|4 Hours Post-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||pg/mL||Standard Deviation|Mean
801660|NCT00976599|Primary|Parathyroid Hormone (PTH) Level at 1 Hour Post-dose on Day 1|Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.|1 Hour Post-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||pg/mL||Standard Deviation|Mean
801661|NCT00976599|Primary|Parathyroid Hormone (PTH) Level at Pre-dose on Day 1|Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.|Pre-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication.||pg/mL||Standard Deviation|Mean
801662|NCT00976599|Primary|Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at Pre-dose on Day 35 or Early Termination|Blood/serum samples were analyzed for MMP3, osteocalcin and osteopontin concentrations using a validated analytical assay sensitive and specific ELISA method for MMP3 and osteopontin in serum samples; specific electrochemiluminescence method for osteocalcin in blood samples.|Pre-dose on Day 35 or Early Termination|FAS included all randomized participants who received at least 1 dose of the study medication.||ng/mL||Standard Deviation|Mean
801663|NCT00976599|Primary|Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 24 Hours Post-dose on Day 28|Blood/serum samples were analyzed for MMP3, osteocalcin and osteopontin concentrations using a validated analytical assay sensitive and specific ELISA method for MMP3 and osteopontin in serum samples; specific electrochemiluminescence method for osteocalcin in blood samples.|24 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||ng/mL||Standard Deviation|Mean
801664|NCT00976599|Primary|Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 8 Hours Post-dose on Day 28|Blood/serum samples were analyzed for MMP3, osteocalcin and osteopontin concentrations using a validated analytical assay sensitive and specific ELISA method for MMP3 and osteopontin in serum samples; specific electrochemiluminescence method for osteocalcin in blood samples.|8 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||ng/mL||Standard Deviation|Mean
801665|NCT00976599|Primary|Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 4 Hours Post-dose on Day 28|Blood/serum samples were analyzed for MMP3, osteocalcin and osteopontin concentrations using a validated analytical assay sensitive and specific ELISA method for MMP3 and osteopontin in serum samples; specific electrochemiluminescence method for osteocalcin in blood samples.|4 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||ng/mL||Standard Deviation|Mean
801666|NCT00976599|Primary|Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 1 Hour Post-dose on Day 28|Blood/serum samples were analyzed for MMP3, osteocalcin and osteopontin concentrations using a validated analytical assay sensitive and specific ELISA method for MMP3 and osteopontin in serum samples; specific electrochemiluminescence method for osteocalcin in blood samples.|1 Hour Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication.||ng/mL||Standard Deviation|Mean
801756|NCT00976989|Primary|Safety: Percentage of Participants With Symptomatic Cardiac Events as Assessed by the Investigator|Left ventricular systolic dysfunction (LVSD) as assessed by the Investigator, including Grade 3, 4 or 5 symptomatic LVSD with symptomatic cardiac events.|From baseline up to approximately 3.5 years|Safety population included all participants who were randomized and received study drug.||percentage of participants|||Number
801667|NCT00976599|Primary|Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at Pre-dose on Day 28|Blood/serum samples were analyzed for MMP3, osteocalcin and osteopontin concentrations using a validated analytical assay sensitive and specific ELISA method for MMP3 and osteopontin in serum samples; specific electrochemiluminescence method for osteocalcin in blood samples.|Pre-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication.||ng/mL||Standard Deviation|Mean
801668|NCT00976599|Primary|Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at Pre-dose on Day 10|Blood/serum samples were analyzed for MMP3, osteocalcin and osteopontin concentrations using a validated analytical assay sensitive and specific ELISA method for MMP3 and osteopontin in serum samples; specific electrochemiluminescence method for osteocalcin in blood samples.|Pre-dose on Day 10|FAS included all randomized participants who received at least 1 dose of the study medication.||ng/mL||Standard Deviation|Mean
801669|NCT00976599|Primary|Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 4 Hours Post-dose on Day 1|Blood/serum samples were analyzed for MMP3, osteocalcin and osteopontin concentrations using a validated analytical assay sensitive and specific ELISA method for MMP3 and osteopontin in serum samples; specific electrochemiluminescence method for osteocalcin in blood samples.|4 Hours Post-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication.||ng/mL||Standard Deviation|Mean
801670|NCT00976599|Primary|Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 1 Hour Post-dose on Day 1|Blood/serum samples were analyzed for MMP3, osteocalcin and osteopontin concentrations using a validated analytical assay sensitive and specific ELISA method for MMP3 and osteopontin in serum samples; specific electrochemiluminescence method for osteocalcin in blood samples.|1 Hour Post-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication.||ng/mL||Standard Deviation|Mean
801671|NCT00976599|Primary|Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at Pre-dose on Day 1|Blood/serum samples were analyzed for MMP3, osteocalcin and osteopontin concentrations using a validated analytical assay sensitive and specific Enzyme-Linked Immunosorbent Assay [ELISA] method for MMP3 and osteopontin in serum samples; specific electrochemiluminescence method for osteocalcin in blood samples).|Pre-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
801672|NCT00976599|Primary|Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination|Blood samples were collected for FACS analysis of lymphocyte subsets. Lymphocyte subset counts of T cells, B cells and NK cells were analyzed using fluorescent-labeled antibodies against CD markers.|Pre-dose on Day 35 or Early Termination|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||cells/mcL||Standard Deviation|Mean
801673|NCT00976599|Primary|Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28|Blood samples were collected for FACS analysis of lymphocyte subsets. Lymphocyte subset counts of T cells, B cells and NK cells were analyzed using fluorescent-labeled antibodies against CD markers.|24 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||cells/mcL||Standard Deviation|Mean
801674|NCT00976599|Primary|Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28|Blood samples were collected for FACS analysis of lymphocyte subsets. Lymphocyte subset counts of T cells, B cells and NK cells were analyzed using fluorescent-labeled antibodies against CD markers.|8 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||cells/mcL||Standard Deviation|Mean
801675|NCT00976599|Primary|Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28|Blood samples were collected for FACS analysis of lymphocyte subsets. Lymphocyte subset counts of T cells, B cells and NK cells were analyzed using fluorescent-labeled antibodies against CD markers.|4 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||cells/mcL||Standard Deviation|Mean
801676|NCT00976599|Primary|Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28|Blood samples were collected for FACS analysis of lymphocyte subsets. Lymphocyte subset counts of T cells, B cells and NK cells were analyzed using fluorescent-labeled antibodies against CD markers.|1 Hour Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||cells/mcL||Standard Deviation|Mean
801677|NCT00976599|Primary|Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28|Blood samples were collected for FACS analysis of lymphocyte subsets. Lymphocyte subset counts of T cells, B cells and NK cells were analyzed using fluorescent-labeled antibodies against CD markers.|Pre-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||cells/mcL||Standard Deviation|Mean
801678|NCT00976599|Primary|Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10|Blood samples were collected for FACS analysis of lymphocyte subsets. Lymphocyte subset counts of T cells, B cells and NK cells were analyzed using fluorescent-labeled antibodies against CD markers.|Pre-dose on Day 10|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||cells/mcL||Standard Deviation|Mean
801679|NCT00976599|Primary|Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1|Blood samples were collected for FACS analysis of lymphocyte subsets. Lymphocyte subset counts of T cells, B cells and NK cells were analyzed using fluorescent-labeled antibodies against CD markers.|4 Hours Post-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||cells/mcL||Standard Deviation|Mean
801780|NCT00977106|Secondary|Hemoglobin Concentration During the Double-Blind Treatment Period|Hemoglobin concentrations were determined at each visit to evaluate anemia in participants and measured as grams per deciliter (g/dL).|Baseline and Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||g/dL||Standard Deviation|Mean
801680|NCT00976599|Primary|Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1|Blood samples were collected for FACS analysis of lymphocyte subsets. Lymphocyte subset counts of T cells, B cells and NK cells were analyzed using fluorescent-labeled antibodies against CD markers.|1 Hour Post-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||cells/mcL||Standard Deviation|Mean
801681|NCT00976599|Primary|Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1|Blood samples were collected for fluorescence-activated cell sorting [FACS] analysis of lymphocyte subsets. Lymphocyte subset counts of T cells, Bone-marrow cells (B cells) and natural killer (NK) cells were analyzed using fluorescent-labeled antibodies against clusters of differentiation (CD) markers.|Pre-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||cells per microliter (cells/mcL)||Standard Deviation|Mean
801682|NCT00976599|Primary|Blood Cytokine Level at Pre-dose on Day 35 or Early Termination|Blood samples were collected from all the participants and pro-inflammatory cytokine levels were measured. The levels of pro-inflammatory cytokine IL-1beta, IL-1alpha, IL-4, IL-6, IL-8, IL-10, IL-17A, IL-7, IL-21, IL-12p70, IP-10, TNFalpha, IFNgamma, GM-CSF, MIP1a, MCP1, sVEGF, sVCAM-1, sICAM-1, G-CSF was measured by immunoassay and the levels were expresses as pg/mL.|Pre-dose on Day 35 or Early Termination|FAS included all randomized participants who received at least 1 dose of the study medication.||pg/mL||Standard Deviation|Mean
801683|NCT00976599|Primary|Blood Cytokine Level at 24 Hours Post-dose on Day 28|Blood samples were collected from all the participants and pro-inflammatory cytokine levels were measured. The levels of pro-inflammatory cytokine IL-1beta, IL-1alpha, IL-4, IL-6, IL-8, IL-10, IL-17A, IL-7, IL-21, IL-12p70, IP-10, TNFalpha, IFNgamma, GM-CSF, MIP1a, MCP1, sVEGF, sVCAM-1, sICAM-1, G-CSF was measured by immunoassay and the levels were expresses as pg/mL.|24 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication.||pg/mL||Standard Deviation|Mean
801684|NCT00976599|Primary|Blood Cytokine Level at 8 Hours Post-dose on Day 28|Blood samples were collected from all the participants and pro-inflammatory cytokine levels were measured. The levels of pro-inflammatory cytokine IL-1beta, IL-1alpha, IL-4, IL-6, IL-8, IL-10, IL-17A, IL-7, IL-21, IL-12p70, IP-10, TNFalpha, IFNgamma, GM-CSF, MIP1a, MCP1, sVEGF, sVCAM-1, sICAM-1, G-CSF was measured by immunoassay and the levels were expresses as pg/mL.|8 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||pg/mL||Standard Deviation|Mean
801685|NCT00976599|Primary|Blood Cytokine Level at 4 Hours Post-dose on Day 28|Blood samples were collected from all the participants and pro-inflammatory cytokine levels were measured. The levels of pro-inflammatory cytokine IL-1beta, IL-1alpha, IL-4, IL-6, IL-8, IL-10, IL-17A, IL-7, IL-21, IL-12p70, IP-10, TNFalpha, IFNgamma, GM-CSF, MIP1a, MCP1, sVEGF, sVCAM-1, sICAM-1, G-CSF was measured by immunoassay and the levels were expresses as pg/mL.|4 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||pg/mL||Standard Deviation|Mean
801686|NCT00976599|Primary|Blood Cytokine Level at 1 Hour Post-dose on Day 28|Blood samples were collected from all the participants and pro-inflammatory cytokine levels were measured. The levels of pro-inflammatory cytokine IL-1beta, IL-1alpha, IL-4, IL-6, IL-8, IL-10, IL-17A, IL-7, IL-21, IL-12p70, IP-10, TNFalpha, IFNgamma, GM-CSF, MIP1a, MCP1, sVEGF, sVCAM-1, sICAM-1, G-CSF was measured by immunoassay and the levels were expresses as pg/mL.|1 Hour Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication.||pg/mL||Standard Deviation|Mean
801687|NCT00976599|Primary|Blood Cytokine Level at Pre-dose on Day 28|Blood samples were collected from all the participants and pro-inflammatory cytokine levels were measured. The levels of pro-inflammatory cytokine IL-1beta, IL-1alpha, IL-4, IL-6, IL-8, IL-10, IL-17A, IL-7, IL-21, IL-12p70, IP-10, TNFalpha, IFNgamma, GM-CSF, MIP1a, MCP1, sVEGF, sVCAM-1, sICAM-1, G-CSF was measured by immunoassay and the levels were expresses as pg/mL.|Pre-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication.||pg/mL||Standard Deviation|Mean
801688|NCT00976599|Primary|Blood Cytokine Level at Pre-dose on Day 10|Blood samples were collected from all the participants and pro-inflammatory cytokine levels were measured. The levels of pro-inflammatory cytokine IL-1beta, IL-1alpha, IL-4, IL-6, IL-8, IL-10, IL-17A, IL-7, IL-21, IL-12p70, IP-10, TNFalpha, IFNgamma, GM-CSF, MIP1a, MCP1, sVEGF, sVCAM-1, sICAM-1, G-CSF was measured by immunoassay and the levels were expresses as pg/mL.|Pre-dose on Day 10|FAS included all randomized participants who received at least 1 dose of the study medication.||pg/mL||Standard Deviation|Mean
801689|NCT00976599|Primary|Blood Cytokine Level at 4 Hours Post-dose on Day 1|Blood samples were collected from all the participants and pro-inflammatory cytokine levels were measured. The levels of pro-inflammatory cytokine IL-1beta, IL-1alpha, IL-4, IL-6, IL-8, IL-10, IL-17A, IL-7, IL-21, IL-12p70, IP-10, TNFalpha, IFNgamma, GM-CSF, MIP1a, MCP1, sVEGF, sVCAM-1, sICAM-1, G-CSF was measured by immunoassay and the levels were expresses as pg/mL.|4 hours post-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||pg/mL||Standard Deviation|Mean
801690|NCT00976599|Primary|Blood Cytokine Level at 1 Hour Post-dose on Day 1|Blood samples were collected from all the participants and pro-inflammatory cytokine levels were measured. The levels of pro-inflammatory cytokine IL-1beta, IL-1alpha, IL-4, IL-6, IL-8, IL-10, IL-17A, IL-7, IL-21, IL-12p70, IP-10, TNFalpha, IFNgamma, GM-CSF, MIP1a, MCP1, sVEGF, sVCAM-1, sICAM-1, G-CSF was measured by immunoassay and the levels were expresses as pg/mL.|1 hour post-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication.||pg/mL||Standard Deviation|Mean
801702|NCT00976703|Secondary|Patient Pain/Comfort Rating|Using a visual analog pain scale, with 0 being no pain and 10 being the most severe pain possible, the patients were asked to assess their pain every hour. The highest pain score recorded while the Foley catheter was in place was used. The data are reported as the median and range.|an average of 20 hours, up to 40 hours|All patients had pain scores recorded and used in analysis. The values in the table represented the recorded data available and used in the analysis.||units on a scale||Full Range|Median
823787|NCT01175902|Primary|Intraocular Pressure (IOP), Period 1|IOP (mean IOP) after 4 weeks of treatment|4 weeks|||mmHg||Standard Deviation|Mean
801691|NCT00976599|Primary|Blood Cytokine Level at Pre-dose on Day 1|Blood samples were collected from all the participants and pro-inflammatory cytokine levels were measured. The levels of pro-inflammatory cytokine IL-1beta, IL-1alpha, IL-4, IL-6, IL-8, IL-10, IL-17A, IL-7, IL-21, active 70 kDa (p70) form of IL-12(IL-12p70), interferon gamma (IFNgamma) - induced protein 10 (IP-10), TNFalpha, granulocyte macrophage colony-stimulating factor (GM-CSF), macrophage inflammatory protein 1 alpha (MIP1a), monocyte chemotactic protein 1 (MCP1), soluble vascular endothelial growth factor (sVEGF), soluble vascular cell adhesion molecule 1 (sVCAM-1), soluble intercellular adhesion molecule 1 (sICAM-1), granulocyte colony-stimulating factor (G-CSF) was measured by immunoassay and the levels were expresses as picogram per milliliter (pg/mL).|Pre-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication.||pg/mL||Standard Deviation|Mean
801692|NCT00976599|Primary|Blood Levels for Gene Expression (Messenger Ribonucleic Acid [mRNA]) at Day 28|Blood levels were utilized for expression analysis (mRNA) of following genes that reflect immune function: CD19, CD3E, STAT1, STAT3, ISG15, CXCL10. mRNA gene expression in blood were assayed by quantitative PCR using standard curve method. Standard curve generated by linear regression using log threshold cycle versus log (cell number). Data were presented as control gene normalized expression (relative expression) within blood.|Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||REU||Standard Deviation|Mean
801693|NCT00976599|Primary|Blood Levels for Gene Expression (Messenger Ribonucleic Acid [mRNA]) at Baseline (Day-7)|Blood levels were utilized for expression analysis (mRNA) of following genes that reflect immune function: CD19, CD3 epsilon (CD3E), STAT1, STAT3, ISG15, CXCL10. mRNA gene expression in blood were assayed by quantitative PCR using standard curve method. Standard curve generated by linear regression using log threshold cycle versus log (cell number). Data were presented as control gene normalized expression (relative expression) within blood.|Baseline (Day -7)|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||REU||Standard Deviation|Mean
801694|NCT00976599|Primary|Change From Baseline in Percentage of Area Stained For CD3+ and CD68+ Surface Markers of Inflammatory Cells of the Synovial Tissue at Day 28|The intensity of CD3 and CD68 cell infiltration was expressed as the percentage area of the tissue section occupied by positively stained cells. Surface marker CD68 macrophages and CD3 thymus cells (T cells) in the inflammatory cells of synovial tissue were detected by immunohistochemical staining.|Baseline (Day -7), Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||percentage area stained||Standard Deviation|Mean
801695|NCT00976599|Primary|Change From Baseline in Protein Expression of Tumor Necrosis Factor Alpha (TNFalpha), Interleukin-6 (IL-6), Interleukin-17a (IL-17a) and Interleukin-10 (IL-10) at Day 28|Synovial tissue biopsy was to be performed and assayed for protein expression by quantitative PCR using standard curve method. Standard curve was to be generated by linear regression using log threshold cycle versus log (cell number). TNFalpha, IL-6, IL-17 and IL-10 data were to be presented as control normalized expression (relative expression) within synovial tissue.|Baseline (Day -7), Day 28|Analyses of TNFalpha, IL-6, IL-17 and IL-10 were not performed due to insufficient samples and lack of appropriate method to process/analyze the samples.|||||
801696|NCT00976599|Primary|Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28|Synovial tissue biopsy were performed and assayed for mRNA gene expression by quantitative polymerized chain reaction (PCR) using standard curve method. Standard curve generated by linear regression using log threshold cycle versus log (cell number). Interleukin-1beta (IL-1beta), IL-6, matrix metalloproteinase-3 (MMP3), cluster of differentiation 19 (CD19), cluster of differentiation 3 epsilon (CD3E), Janus kinase 1 (JAK1), JAK2, JAK3, signal transducers, activators of transcription (STAT1), interferon stimulated gene 15 (ISG15), C-X-C motif chemokine 10 (CXCL10), chemokine (C-C motif) ligand2 (CCL2), phospho-STAT1 (pSTAT1), pSTAT3, tumor necrosis factor alpha (TNFalpha), receptor activator of nuclear factor kappa-B ligand (RANKL) and osteoprotegerin (OPG) presented as control gene normalized expression (relative expression) within synovial tissue.|Day -7 (Baseline), Day 28|Full analysis set (FAS) included all randomized participants who received at least 1 dose of the study medication. Analyses of tumor necrosis factor alpha(TNFα), receptor activator of nuclear factor kappa-B ligand(RANKL), osteoprotegerin(OPG) were not performed due to insufficient samples and lack of appropriate method to process/analyze samples.||relative expression unit (REU)||Standard Deviation|Mean
801697|NCT00976664|Primary|Oswestry Disability Index (ODI)|This index measures the functional disability of the subject, points on this index can range from 0-50. A higher numeric value on this scale indicates a worse outcome or increased disability (e.g. 0-10: minimal disability; 11-20: moderate disability; 21-30: severe disability; 31-50: crippling). Absolute scores are reported in the data table.|Randomization, Week 6, and Week 12|Three participants were lost to follow-up in the Orthotic group and one was lost to follow-up in the Wait group, resulting in a drop from 25 participants in each group to 22 and 24 respectively.||units on a scale||Standard Deviation|Mean
801698|NCT00976664|Primary|Visual Analog Scale (VAS)|This scale measures pain on a scale of 0 (no pain) to 10 (worst pain imaginable). A higher score on this scale indicates a worse outcome or increase in pain.|Randomization, Week 6, and Week 12|Three participants were lost to follow-up in the Orthotic group and one was lost to follow-up in the Wait group, resulting in a drop from 25 participants in each group to 22 and 24 respectively.||units on a scale||Standard Deviation|Mean
801699|NCT00976677|Primary|Progression-free Survival (PFS)|Progression-free survival (PFS) is defined to be the time from randomization to progression of disease or death, whichever occurs first. Progressive disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study, or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|Every 6 weeks during treatment and every 3 months in follow-up until disease progression or up to 5 years|All eligible and treated patients are included in this analysis.||Months||95% Confidence Interval|Median
801700|NCT00976703|Other Pre-specified|Maternal Morbidities|post-partum hemorrhage, clinical chorionamnionitis, endomyometritis, cervical laceration, second procedure, readmission, DVT|30 days after delivery|||diagnoses|||Number
801704|NCT00976716|Secondary|Summary of Adverse Events|The number of subjects who experienced adverse events (AEs; all-causality and treatment-related) based on safety assessment was summarized. The severity and seriousness of treatment-emergent AEs as well as discontinuations, dose reductions and temporary discontinuations (DR/TD) due to treatment-emergent AEs were also summarized.|8 days|The safety analysis set consisted of all patients who had taken at least one study medication.||Participants|||Number
801705|NCT00976716|Secondary|Withdrawal Due to Lack of Efficacy|The number of subjects who withdrew due to insufficient clinical response was evaluated.|8 days|The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints.||Participants|||Number
801706|NCT00976716|Secondary|Severity of Inflammatory Symptoms (Localized Warmth) Within 8 Days Post First Dose|The investigator assessed the localized warmth, using the categories “None,” “Mild,” “Moderate,” and “Severe” at Baseline, Visit 2 (Day 4), Visit 3 (Day 8) and Final Visit.|Baseline, Days 4 (Visit 2) and 8 (Visit 3)|The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the LOCF was used.||Participants|||Number
801707|NCT00976716|Secondary|Severity of Inflammatory Symptoms (Redness) Within 8 Days Post-first Dose|The investigator assessed the redness, using the categories “None,” “Mild,” “Moderate,” and “Severe” at Baseline, Visit 2 (Day 4), Visit 3 (Day 8) and Final Visit.|Baseline, Days 4 (Visit 2) and 8 (Visit 3)|The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the LOCF was used.||Participants|||Number
801708|NCT00976716|Secondary|Severity of Inflammatory Symptoms (Swelling) Within 8 Days Post-first Dose|The investigator assessed the swelling, using the categories “None,” “Mild,” “Moderate,” and “Severe” at Baseline, Visit 2 (Day 4), Visit 3 (Day 8) and Final Visit.|Baseline, Days 4 (Visit 2) and 8 (Visit 3)|The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the LOCF was used.||Participants|||Number
801709|NCT00976716|Secondary|Peak Pain Intensity Difference (PPID) for Pain at Rest (Spontaneous Pain) and on Active Movement Until 6 Hours Post-first Dose|The PPID was obtained by subtracting the maximum value of pain intensity (PI) at a time point among 2 to 6 hours post first dose from baseline value of PI for each patient.|Two, 4 and 6 hours post first dose|The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints.||mm||95% Confidence Interval|Mean
801710|NCT00976716|Secondary|Sum of Pain Intensity Differences (SPID) for Pain at Rest (Spontaneous Pain) and on Active Movement Until 6 Hours Post-first Dose|The SPID was derived according to the following rule: each PID was weighted by the width of time interval between previous and current time points in hours and summed up to 6 hours post-first dose|6 hours|The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement. If a patient withdrew the study before 6 hours on Day 1 and the measurement of the PI at 6 hours on Day 1 was missing, the LOCF method was used for the PI at 6 hours on Day 1 to derive the SPID.||mm||95% Confidence Interval|Mean
801711|NCT00976716|Secondary|PID in Pain on Active Movement Within 8 Days Post-first Dose|The PID score was obtained by subtracting the PI at each time point from the Baseline PI score. Increase in scores indicated a lessening of subjects' pain compared to baseline scores; higher scores indicated a greater reduction in pain.|2, 4 and 6 hours post first dose, and before sleep on Day 1, on awakening and before sleep on Days 2 to 7, on awakening on Day 8 and Visit 3 (Day 8)|The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the LOCF was used.||mm||Standard Deviation|Mean
801712|NCT00976716|Secondary|Pain Intensity Differences (PID) in Pain at Rest (Spontaneous Pain) Within 8 Days Post-first Dose|The PID score was obtained by subtracting the PI (by VAS: 0 mm=no pain, 100 mm=worst possible pain) at each time point from the Baseline PI score. Increase in PID scores indicated a lessening of subjects' pain compared to baseline scores; higher scores indicated a greater reduction in pain.|Two, 4 and 6 hours post first dose, and before sleep on Day 1, on awakening and before sleep on Days 2 to 7, on awakening on Day 8 and Visit 3 (Day 8)|The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the LOCF was used.||mm||Standard Deviation|Mean
801713|NCT00976716|Secondary|PI of Pain on Active Movement as Measured by VAS Within 8 Days Post-first Dose|The PI of pain on active movement was recorded on the 100 mm VAS in the patient diary, where 0 mm=no pain, 100 mm=worst possible pain.|Baseline, 2, 4 and 6 hours post first dose, and before sleep on Day 1, on awakening and before sleep on Days 2 to 7, on awakening on Day 8 and Visit 3 (Day 8)|The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the LOCF was used.||mm||Standard Deviation|Mean
801714|NCT00976716|Secondary|Pain Intensity (PI) of Pain at Rest (Spontaneous Pain) as Measured by Visual Analog Scale (VAS) Within 8 Days Post-first Dose|The PI of pain at rest (spontaneous pain) was recorded on the 100 mm VAS in the patient diary, where 0 mm=no pain, 100 mm=worst possible pain.|Baseline, 2, 4 and 6 hours post first dose, and before sleep on Day 1, on awakening and before sleep on Days 2 to 7, on awakening on Day 8 and Visit 3 (Day 8)|The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the LOCF was used.||mm||Standard Deviation|Mean
801901|NCT00977938|Secondary|Definite or Probable Stent Thrombosis (ST) - Randomized BMS ITT|ST was assessed according to the Academic Research Consortium (ARC) definitions.|21 months (12-33 months post-index procedure)|All randomized BMS ITT patients; Patients were analyzed according to the treatment to which they were randomized (regardless of post-randomization compliance with the randomized treatment); Patients not experiencing the endpoint were censored at 33 months or at last known follow-up, whichever was earlier.||percentage of patients (KM estimate)|||Number
801715|NCT00976716|Secondary|Patient Impressions Within 8 Days Post-first Dose (the Number of Subjects Who Have Rated “Excellent” and “Good”)|"The patient impression of the study medication was entered in the patient diary based on the following categories: “excellent,” “good,” “fair” and “poor.”
Efficacy was based on the patient impression of the study medication (excellent and good) from the first study medication until each time point."|6 hours post first dose and before sleep on Day 1, before sleep on Day 2, Day 4 (Visit 2) and Day 8 (Visit 3)|The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints.||Participants|||Number
801716|NCT00976716|Primary|Patient Impressions at Final Visit (the Number of Participants Who Have Rated “Excellent” and “Good”)|"The patient impression of the study medication was entered in the patient diary based on the following categories: “excellent,” “good,” “fair” and “poor.”
Efficacy was based on the patient impression of the study medication (“excellent” and “good”) from the first study medication until Final Visit."|8 days|The full analysis set (FAS) consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the last observation carried forward (LOCF) was used.||Participants|||Number
801717|NCT00976911|Secondary|European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Ovarian (OV) 28 Abdominal/Gastrointestinal (AB/GI) Symptom Scale - Percentage of Responders (Data Cutoff 14 November 2011)|The EORTC OV-28 module is a questionnaire that focuses on issues specific to ovarian cancer. It assesses AB/GI symptoms, among others. Participants were asked to indicate the extent to which they experienced AB/GI symptoms in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following: Did you have abdominal pain? Did you have a bloated feeling in your abdomen/stomach? Did you have problems with your clothes feeling too tight? Did you experience any change in bowel habit as a result of your disease or treatment? Were you troubled by passing wind/gas/flatulence? Have you felt full too quickly after beginning to eat? Have you had indigestion/heartburn? Data are transformed to a scale from 0 to 100. Lower scores represent better health (fewer symptoms). Participants were considered a responder if they had a 10 point or more reduction in EORTC QLQ-OV28 AB/GI symptom scale score from baseline.|Baseline and Weeks 8, 9, 16, 18, 24 and 30 (Data Cutoff 14 November 2011)|ITT population; n (number) = (equals) number of participants that completed the questionnaire at baseline and at the specified visit.||percentage of participants||95% Confidence Interval|Number
801718|NCT00976911|Secondary|Overall Survival (Data Cutoff 25 January 2013)|Duration of overall survival was defined as the time from randomization to death of any cause. Kaplan-Meier methodology was used. The OS data for participants for whom no death was captured in the clinical database were censored at the last time they were known to be alive. 95% CI was computed using the method of Brookmeyer and Crowley.|Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 25 January 2013|ITT Population; only participants who died were included in the analysis.||months||95% Confidence Interval|Median
801719|NCT00976911|Primary|Progression Free Survival (PFS; Data Cutoff 14 November 2011)|PFS was defined as the time from the date of randomization to the first documented disease progression or death, whichever occurred first. Progression was based on tumor assessment made by the investigators according to the RECIST criteria (for participants with measurable disease), and for those with non-measurable disease presence or absence of lesions was noted. Time from randomization to occurrence of disease progression or death was measured in months. An event was defined as the earliest progressive disease or death that occurred on or before the cutoff date (14 November 2011), regardless of start of nonprotocol specified anti-cancer therapy or the bevacizumab monotherapy. Disease progression was assessed by investigator according to RECIST or by symptom deterioration, and could not be declared on the basis of rising cancer antigen 125 (CA125) levels alone. Kaplan-Meier methodology was used. 95% CI for median was computed using the method of Brookmeyer and Crowley.|Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 14 November 2011|ITT Population; only participants with an event of progression or death were included in the analysis||months||95% Confidence Interval|Median
801720|NCT00976911|Secondary|Percentage of Participants Who Died (Data Cutoff 25 January 2013)||Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 25 January 2013|ITT Population||percentage of participants|||Number
801721|NCT00976911|Secondary|Duration of Objective Response (Data Cutoff 14 November 2011)|For randomized participants who achieved an objective response per modified RECIST, duration of objective response was defined as the time from the date of the first occurrence of a CR or PR (whichever occurred first) until the date that progressive disease or death was documented (whichever occurred first). Participants who had an objective response and did not experience disease progression or death by the time of analysis were censored at the time of the last tumor assessment. Summaries of duration of objective response (median and percentiles) were estimated from Kaplan−Meier curves. 95% CI for duration of objective response was computed using the method of Brookmeyer and Crowley.|Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 14 November 2011|ITT Population; only participants with a best overall confirmed response of CR or PR were included in the analysis.||months||95% Confidence Interval|Median
801731|NCT00976937|Secondary|Change From Baseline in Insulin Resistance Assessed by Homeostasis Model Assessment- Insulin Resistance (HOMA-IR) at Week 24|HOMA-IR was derived from FPG and FPI as: (FPI [micro units per milliliter]*FPG [mmol/L]) divided by 22.5. Change was calculated for HOMA-IR by subtracting the baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HOMA-IR assessment during on-treatment period.||mU * mmol/L^2||Standard Error|Least Squares Mean
805487|NCT01003184|Secondary|Change in Body Weight From Baseline to Week 26|Change in body weight from baseline to week 26|Baseline, Week 26|The analysis was done for the FAS population (as randomised).||kilograms||Standard Error|Least Squares Mean
801722|NCT00976911|Secondary|Percentage of Participants With Best Overall Confirmed Objective Response of Complete Response (CR) or Partial Response (PR) Per Modified RECIST (Data Cutoff 14 November 2011)|Objective Response was determined by the investigator using modified RECIST criteria, Version 1.0. An objective response was a complete or partial overall confirmed response as determined by investigators. CR defined as complete disappearance of all target and non-target lesions and no new lesions. PR defined as greater than or equal to (≥) 30 percent (%) decrease in the sum of appropriate diameters of all target measurable lesions, no progress in the non-measurable disease, and no new lesions. 95% CI computed using the normal approximation to the binomial distribution.|Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 14 November 2011|ITT Population; only participants with measurable disease at baseline were included in the analysis.||percentage of participants||95% Confidence Interval|Number
801723|NCT00976911|Primary|Percentage of Participants With Disease Progression or Death (Data Cutoff 14 November 2011)|Progression free survival was defined as the time from the date of randomization to the first documented disease progression or death, whichever occurs first. Progression was based on tumour assessment made by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria (for participants with measurable disease), and for those with non-measurable disease presence or absence of lesions was noted.|Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 14 November 2011|ITT Population: All participants randomized to study treatment, irrespective of whether or not the assigned treatment was actually received. For all efficacy analyses, participants were grouped according to the treatment assigned at randomization||percentage of participants|||Number
801724|NCT00976937|Other Pre-specified|Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia|Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the patient required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.|First dose of study drug up to 3 days after the last dose administration|Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.||participants|||Number
801725|NCT00976937|Other Pre-specified|Change From Baseline in Fasting Proinsulin-to-insulin Ratio and 2-hour Postprandial Proinsulin-to-insulin Ratio at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of the study drug or up to the introduction of rescue therapy, whichever is the earliest.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline proinsulin-to-insulin ratio assessment during on-treatment period and 'n' = patients with baseline and at least 1 post-baseline assessment for the specified category.||ratio||Standard Error|Least Squares Mean
801726|NCT00976937|Other Pre-specified|Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest.|Baseline, Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.||percentage of participants|||Number
801727|NCT00976937|Secondary|Percentage of Patients Requiring Rescue Therapy During 24-Week Period|Routine fasting self-measured plasma glucose (SMPG) and central laboratory FPG (and HbA1c after week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after week 12) were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG >270 milligram/deciliter (mg/dL) (15.0 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 24: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >8.5%.|Baseline up to Week 24|mITT population.||percentage of participants|||Number
801728|NCT00976937|Other Pre-specified|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.||percentage of participants|||Number
801729|NCT00976937|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 24|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.||percentage of participants|||Number
801730|NCT00976937|Secondary|Change From Baseline in Beta Cell Function Assessed by Homeostasis Model Assessment–Beta (HOMA-beta) at Week 24|HOMA-beta was derived from FPG and FPI as: (20*FPI [micro units/milliliter]) divided by (FPG [mmol/L] minus 3.5). Change was calculated for HOMA-beta by subtracting the baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HOMA-beta assessment during on-treatment period.||percentage of normal beta cells function||Standard Error|Least Squares Mean
801755|NCT00976989|Primary|Safety: Percentage of Participants With Left Ventricular Ejection Fraction (LVEF) Decline During Pre-operative (Neoadjuvant) Period|Percentage of participants with LVEF measures decline of ≥ 10% from baseline and to a value of <50% during the pre-operative (neoadjuvant) period.|From baseline up to approximately 18 weeks|Safety population included all participants who were randomized and received study drug.||percentage of participants|||Number
801732|NCT00976937|Secondary|Change From Baseline in Fasting Proinsulin and 2-hour Postprandial Proinsulin at Week 24|Change was calculated for fasting proinsulin and 2-hour postprandial proinsulin by subtracting the baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of the study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline proinsulin assessment during on-treatment period and 'n' = patients with baseline and at least 1 post-baseline assessment for the specified category.||pmol/L||Standard Error|Least Squares Mean
801733|NCT00976937|Secondary|Change From Baseline in Fasting Glucagon and 2-hour Postprandial Glucagon at Week 24|Change was calculated for fasting glucagon and 2-hour postprandial glucagon by subtracting the baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline glucagon assessment during on-treatment period and 'n' = patients with baseline and at least 1 post-baseline assessment for the specified category.||ng/L||Standard Error|Least Squares Mean
801734|NCT00976937|Secondary|Change From Baseline in Fasting C-peptide and 2-hour Postprandial C-peptide at Week 24|Change was calculated for fasting C-peptide and 2-hour postprandial C-peptide by subtracting the baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline C-peptide assessment during on-treatment period and 'n' = patients with baseline and at least 1 post-baseline assessment for the specified category.||nmol/L||Standard Error|Least Squares Mean
801735|NCT00976937|Secondary|Change From Baseline in Fasting Plasma Insulin (FPI) and 2-hour Postprandial Plasma Insulin (PPI) at Week 24|Change was calculated for fasting plasma insulin and 2-hour post prandial plasma insulin by subtracting the baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of the study drug or up to the introduction of rescue therapy, whichever is the earliest.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline plasma insulin assessment during on-treatment period and 'n' = patients with baseline and at least 1 post-baseline assessment for the specified category.||pmol/L||Standard Error|Least Squares Mean
801736|NCT00976937|Secondary|Change From Baseline in Glucose Excursion at Week 24|Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the standardized meal test, before study drug administration. Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of the study drug or up to the introduction of rescue therapy, whichever is the earliest.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline glucose excursion assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
801737|NCT00976937|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 1 day after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline FPG assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
801738|NCT00976937|Secondary|Change From Baseline in 2-hour Postprandial Plasma Glucose (PPG) at Week 24|The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of the study drug or up to the introduction of rescue therapy, whichever is the earliest.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline 2-hour PPG assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
801739|NCT00976937|Secondary|Change From Baseline in Body Weight at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.||kilogram||Standard Error|Least Squares Mean
801740|NCT00976937|Secondary|Absolute Change From Baseline in HbA1c at Week 24|Absolute change = HbA1c value at Week 24 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.||percentage of hemoglobin||Standard Error|Least Squares Mean
801741|NCT00976937|Primary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% and at Least 5% Weight Loss From Baseline at Week 24|Percentage of patients who met both criteria (HbA1c <7% at Week 24 and at least 5% weight loss from baseline at Week 24) is reported. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest.|Week 24|mITT population included randomized patients who received at least 1 dose of study drug. Missing data was imputed using Last observation carried forward (LOCF).||percentage of participants|||Number
801742|NCT00976950|Secondary|Change in CD4+ Cell Count From Baseline at Week 48||48 weeks|Treated set with with non-missing data at the visit||cells/mm^3||Standard Deviation|Mean
811714|NCT01059760|Primary|Change From Baseline in Participant Fibroblast Growth Factor-21 (FGF-21) When Fasting and Fed||Baseline and 3 days|||pg/mL||Standard Deviation|Mean
801743|NCT00976950|Secondary|Virologic Response|Virologic response is defined as HIV viral load of < 50 copies/mL before week 48 and without subsequent rebound or change of ARV therapy prior to week 48. A rebound is defined by two consecutive measurements of VL >= 50 copies/ml, at least two weeks apart, after two consecutive measurements of VL< 50 copies/ml. Because of many missing data concerning the viral load, the virologic response could be determined only for four patients.|48 weeks|Treated set (TS), defined as patients treated with Aptivus||Number of participants|||Number
801744|NCT00976950|Primary|Number of Patients Reporting Adverse Events (AE)|Any type of adverse events|48 weeks|Treated set (TS), defined as patients treated with Aptivus||Participants|||Number
801745|NCT00976989|Secondary|Safety: Maximum Decrease in Left Ventricular Ejection Fraction (LVEF) Measures|Maximum decrease in LVEF measures is the change from baseline at worst treatment value. LVEF is measured as percentage.|From baseline up to approximately 3.5 years|Safety analysis population included all randomized participants who received treatment. Number of participants analyzed is total number of participants evaluable.||percentage (ejection fraction)||Standard Deviation|Mean
801746|NCT00976989|Secondary|Safety: Percentage of Participants With Asymptomatic Left Ventricular Ejection Fraction (LVEF) Events|Percentage of participants with LVEF events without signs or symptoms of cardiac events.|From baseline to end of Neoadjuvant Period (up to 18 weeks), Adjuvant Period (up to 1.5 years), Follow-up Period (up to 3.5 years)|Safety analysis population included all randomized participants who received treatment. Number of participants analyzed is total number of participants evaluable during each period.||percentage of participants|||Number
801747|NCT00976989|Secondary|Safety: Percentage of Participants With Cardiac Symptoms Associated With Symptomatic Left Ventricular Systolic Dysfunction (LVSD)|Percentage of participants with signs or symptoms of cardiac events.|From Baseline to end of Neoadjuvant Period (up to 18 weeks), Adjuvant Period (up to 1.5 years), Follow-up Period (up to 3.5 years)|Safety analysis population included all randomized participants who received treatment. Number of participants analyzed is total number of participants evaluable during each period.||percentage of participants|||Number
801748|NCT00976989|Secondary|Efficacy: Percentage of Participants Without a Progression-Free Survival (PFS) Event|Progression-free survival was defined as the time from the date of randomization to the first documentation of PD or death from any cause, whichever occurred first. PD was assessed using RECIST v1.0 and MRI and CBE. It was defined as at least a 20% increase in the sum of diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions. Participants who were withdrawn from the study without documented PD were censored at the date of the last assessment when the participant was known to be free from PD. Participants without post-baseline assessments but known to be alive were censored at the time of randomization plus one day.|From baseline to end of study up to 5 years|ITT population included all participants who were randomized to treatment.||percentage of participants|||Number
801749|NCT00976989|Secondary|Efficacy: Percentage of Participants Without a Disease-Free Survival (DFS) Event|The DFS was defined as the time from the first date of no disease (i.e., date of surgery) to the first documentation of progressive disease (PD) or death. PD was assessed using RECIST v1.0 and MRI and CBE. It was defined as at least a 20% increase in the sum of diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions. Any evidence of contralateral disease in situ was not considered as PD. Participants who were withdrawn from the study without documented PD were censored at the date of the last assessment when the participant was known to be disease-free.|From baseline to end of study up to 5 years|ITT population included all participants who were randomized to treatment. Number of participants analyzed is total number of participants evaluable during each period.||percentage of participants|||Number
801750|NCT00976989|Secondary|Efficacy: Percentage of Participants Without an Overall Survival (OS) Event|Overall survival (OS) was defined as the time from randomization to the date of death from any cause. Participants who were alive or lost to follow-up were censored at the last known alive date. Participants with no post-baseline information were censored at the date of randomization plus one day.|From baseline to end of study up to 5 years|ITT population included all participants who were randomized to treatment.||percentage of participants|||Number
801751|NCT00976989|Secondary|Efficacy: Percentage of Participants Achieving Breast Conserving Surgery|This is the percentage of participants who achieved breast conserving surgery out of the intent-to-treat population without inflammatory breast cancer, as these participants received mastectomy irrespective of their response to neoadjuvant (pre-operative) treatment.|At approximately 18 weeks|Number of participants analyzed represents the participants with T2-3 tumors for whom mastectomy was planned.||percentage of participants|||Number
801752|NCT00976989|Secondary|Efficacy: Time to Clinical Response|Time to clinical response is defined as the time from the date of first dose received to the first date of assessment of clinical response. Clinical response is defined as a response of CR or PR at any time pre-surgery. Per RECIST v1.0 for target lesions and assessed by mammogram or MRI and CBE, CR is disappearance of all target lesions; PR is >=30% decrease in the sum of the longest diameter of target lesions.|Up to 18 weeks|ITT population included all participants who were randomized to treatment.||weeks||95% Confidence Interval|Median
801753|NCT00976989|Secondary|Efficacy: Clinical Response Rate|Tumor response is defined as complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD) and is identified as per local practice. Clinical response rate is defined as the percentage of participants who achieve a response of CR or PR at any time pre-surgery. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by mammogram or magnetic resonance imaging (MRI) and clinical breast examination (CBE), CR is disappearance of all target lesions; PR is >=30% decrease in the sum of the longest diameter of target lesions.|During each 3-week cycle of 6 total cycles: up to 18 weeks|ITT population included all participants who were randomized to treatment.||percentage of participants|||Number
801754|NCT00976989|Secondary|Efficacy: Percentage of Participants With Complete Pathological Response (pCR)|pCR is defined as the absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy. pCR is evaluated after 6 cycles of treatment and surgery or following withdrawal from the study whichever occurs sooner.|At surgery, after 18 weeks (6 cycles) of treatment|Intent to treat (ITT) population included all participants who were randomized to treatment.||percentage of participants||95% Confidence Interval|Number
811715|NCT01059760|Primary|Change From Baseline in Participant Adiponectin When Fasting and Fed||Baseline and 3 days|||ratio of high molecular to total||Standard Deviation|Mean
801757|NCT00977080|Secondary|Number of Participants With Hypercalcemia Defined as Calcium > 10.5 mg/dL and Based on the Mean of at Least 2 Values Obtained During the Evaluation Period (Weeks 21 to 28)|Calcium values obtained during the evaluation period (Weeks 21 to 28) were averaged for each participant with at least 2 calcium values. Participants whose average calcium value was > 10.5 mg/dL were counted.|Weeks 21 to 28|Randomized participants who received at least 1 dose of study drug and who had at least 2 calcium values during the evaluation period (Weeks 21 to 28)||Participants|||Number
801758|NCT00977080|Secondary|Number of Participants With Hypocalcemia Defined as < 8.4 mg/dL and Based on the Mean of at Least 2 Values Obtained During the Evaluation Period (Weeks 21 to 28)|Calcium values obtained during the evaluation period (Weeks 21 to 28) were averaged for each participant with at least 2 calcium values. Participants whose average calcium value was < 8.4 mg/dL were counted.|Weeks 21 to 28|Randomized participants who received at least 1 dose of study drug and who had at least 2 calcium values during the evaluation period (Weeks 21 to 28)||Participants|||Number
801759|NCT00977080|Secondary|Analysis of the Number of Participants Who Achieve a Mean iPTH Value Between 150 and 300 pg/mL During the Evaluation Period (Weeks 21 to 28) Using a Cochran-Mantel-Haenszel Test Controlling for IV and Oral Site Randomization Strata|iPTH values obtained during the evaluation period (Weeks 21 to 28) were averaged for each participant with at least 2 iPTH values. Participants whose average iPTH value was between 150 to 300 pg/mL were counted. Data from both the IV and oral strata were analyzed together.|Weeks 21 to 28|Randomized participants who received at least 1 dose of study drug and who had both a baseline iPTH value and at least 2 iPTH values during the evaluation period (Weeks 21 to 28)||Participants|||Number
801760|NCT00977080|Secondary|Number of Participants Who Achieve at Least 50% Reduction From Baseline in iPTH as Assessed by the Mean iPTH Obtained During the Evaluation Period (Weeks 21 to 28).|iPTH values obtained during the evaluation period (Weeks 21 to 28) were averaged for each participant with both a baseline iPTH value and at least 2 iPTH values. Participants whose average iPTH value showed a 50% reduction from Baseline were counted.|Weeks 21 to 28|Randomized participants who received at least 1 dose of study drug and who had both a baseline iPTH value and at least 2 iPTH values during the evaluation period (Weeks 21 to 28)||Participants|||Number
801761|NCT00977080|Secondary|Number of Participants Who Achieve at Least 30% Reduction From Baseline in Intact Parathyroid Hormone (iPTH) as Assessed by the Mean iPTH Obtained During the Evaluation Period (Weeks 21 to 28).|iPTH values obtained during the evaluation period (Weeks 21 to 28) were averaged for each participant with both a baseline iPTH value and at least 2 iPTH values. Participants whose average iPTH value showed a 30% reduction from Baseline were counted.|Weeks 21 to 28|Randomized participants who received at least 1 dose of study drug and who had both a baseline iPTH value at least 2 iPTH values during the evaluation period (Weeks 21 to 28)||Participants|||Number
801762|NCT00977080|Primary|The Number of Participants Who Achieve a Mean Intact Parathyroid Hormone (iPTH) Value Between 150 to 300 pg/mL During the Evaluation Period (Weeks 21 to 28).|iPTH values obtained during the evaluation period (Weeks 21 to 28) were averaged for each participant with at least 2 iPTH values. Participants whose average iPTH value was between 150 to 300 pg/mL were counted.|Weeks 21 to 28|Randomized participants who received at least 1 dose of study drug and who had both a baseline iPTH value and at least 2 iPTH values during the evaluation period (Weeks 21 to 28)||Participants|||Number
801763|NCT00977106|Secondary|DAS40 During the Open Treatment Period|DAS40 was calculated from the number of swollen joints and tender joints using the 40-joint count, the erythrocyte sedimentation rate, and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS40 score ranged from 0 to 10, where higher scores correspond to greater disease activity.|Baseline and Weeks 12, 24, 36, and 48|One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.||units on a scale||Standard Deviation|Mean
801764|NCT00977106|Secondary|Disease Activity Score Based on 40-Joints Count (DAS40) During the Double-Blind Treatment Period|DAS40 calculated from the number of swollen joints and tender joints using the 40-joint count, the erythrocyte sedimentation rate and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity.|Baseline and Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.||units on a scale||Standard Deviation|Mean
801765|NCT00977106|Secondary|DAS28 During the Open Treatment Period|DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. DAS28 less than or equal to (≤3.2) = low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity.|Baseline and Weeks 12, 24, 36, and 48|One-Year Efficacy Population n=number of participants assessed for the specified parameter at a given visit.||units on a scale||Standard Deviation|Mean
801766|NCT00977106|Secondary|Disease Activity Score Based on 28-Joints Count (DAS28) During the Double-Blind Treatment Period|DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. DAS28 less than or equal to (≤3.2) = low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity.|Baseline and Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.||units on a scale||Standard Deviation|Mean
801767|NCT00977106|Secondary|SJC Based on 40-Joint Count During the Open Treatment Period|Forty joints were assessed for swelling (5 MCP [left and right] joints, 5 PIP [left and right joints], left and right wrists, elbows, shoulders, knees, and ankles, and 5 MTP [left and right] joints). Joints were classified as swollen (1)/not swollen (0) for a total possible score of 0 to 40. Baseline = Last value available before Day 0 (selection or Day 0) for placebo and last value available before Week 4 (Week 1 or Week 4) for tocilizumab group.|Baseline and Weeks 12, 24, 36, and 48|One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.||swollen joints||Standard Deviation|Mean
808485|NCT01033942|Primary|Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 8||Week 8|Not all participants answered every question||participants|||Number
801768|NCT00977106|Secondary|Percent Change From Baseline in SJC Based on 40-Joint Count During the Double-Blind Treatment Period|Forty joints were assessed for swelling (5 MCP [left and right] joints, 5 PIP [left and right joints], left and right wrists, elbows, shoulders, knees, and ankles, and 5 MTP [left and right] joints). Joints were classified as swollen (1)/not swollen (0) giving a total possible SJC score of 0 to 40.|Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.||percent change||Standard Deviation|Mean
801769|NCT00977106|Secondary|SJC Based on 40-Joint Count During the Double-Blind Treatment Period|Forty joints were assessed for swelling (5 MCP [left and right] joints, 5 PIP [left and right joints], left and right wrists, elbows, shoulders, knees, and ankles, and 5 MTP [left and right] joints). Joints were classified as swollen (1)/not swollen (0) giving a total possible SJC score of 0 to 40. Baseline = value at Day 0 if available, value at screening otherwise.|Baseline and Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.||swollen joints||Standard Deviation|Mean
801770|NCT00977106|Secondary|Swollen Joint Count (SJC) Based on 28-Joint Count During the Open Treatment Period|Twenty-eight joints were assessed for swelling (5 MCP [left and right] joints, 5 PIP [left and right joints], left and right wrists, elbows, shoulders, knees, and ankles, and 5 MTP [left and right] joints) . Joints were classified as swollen (1)/not swollen (0) giving a total possible SJC score of 0 to 28. Baseline = Last value available before Day 0 (selection or Day 0) for placebo and last value available before Week 4 (Week 1 or Week 4) for tocilizumab group.|Baseline and Weeks 12, 24, 36, and 48|One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.||swollen joints||Standard Deviation|Mean
801771|NCT00977106|Secondary|Percent Change From Baseline in SJC Based on 28-Joint Count During the Double-Blind Treatment Period|Twenty-eight joints were assessed for swelling. Joints were classified as swollen (1)/not swollen (0) giving a total possible SJC score of 0 to 28.|Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.||percent change||Standard Deviation|Mean
801772|NCT00977106|Secondary|Swollen Joint Count (SJC) Based on 28-Joint Count During the Double-Blind Treatment Period|Twenty-eight joints were assessed for swelling. Joints were classified as swollen (1)/not swollen (0) giving a total possible SJC score of 0 to 28. Baseline = value at Day 0 if available, value at screening otherwise.|Baseline and Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.||swollen joints||Standard Deviation|Mean
801773|NCT00977106|Secondary|TJC Based on 40-Joint Count During the Open Treatment Period|Forty joints were assessed for tenderness (5 MCP [left and right] joints, 5 PIP [left and right joints], left and right wrists, elbows, shoulders, knees, and ankles, and 5 MTP [left and right] joints). Joints were classified as tender (1)/not tender (0) giving a total possible TJC score of 0 to 40. Baseline = Last value available before Day 0 (selection or Day 0) for placebo and last value available before Week 4 (Week 1 or Week 4) for tocilizumab group.|Baseline and Weeks 12, 24, 36, and 48|One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.||tender joints||Standard Deviation|Mean
801774|NCT00977106|Secondary|Percent Change From Baseline in TJC Based on 40-Joint Count During the Double-Blind Treatment Period|Forty joints were assessed for tenderness (5 MCP [left and right] joints, 5 PIP [left and right joints], left and right wrists, elbows, shoulders, knees, and ankles, and 5 MTP [left and right] joints). Joints were classified as tender (1)/not tender (0) giving a total possible TJC score of 0 to 40.|Weeks 1 and 4|One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.||percent change||Standard Deviation|Mean
801775|NCT00977106|Secondary|TJC Based on 40-Joint Count During the Double-Blind Treatment Period|Forty joints were assessed for tenderness (5 MCP [left and right] joints, 5 PIP [left and right joints], left and right wrists, elbows, shoulders, knees, and ankles, and 5 MTP [left and right] joints). Joints were classified as tender (1)/not tender (0) giving a total possible TJC score of 0 to 40. Baseline = value at Day 0 if available, value at screening otherwise.|Baseline and Weeks 1 and 4|One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.||tender joints||Standard Deviation|Mean
801776|NCT00977106|Secondary|TJC Based on 28-Joint Count During the Open Treatment Period|Twenty-eight joints were assessed for tenderness and joints were classified as tender (1)/not tender (0), giving a total possible tender joint count score of 0 to 28. Baseline = Last value available before Day 0 (selection or Day 0) for placebo and last value available before Week 4 (Week 1 or Week 4) for tocilizumab group.|Baseline and Weeks 12, 24, 36, and 48|One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.||tender joints||Standard Deviation|Mean
801777|NCT00977106|Secondary|Percent Change From Baseline in TJC Based on 28-Joint Count During the Double-Blind Treatment Period|Twenty-eight joints were assessed for tenderness. Joints were classified as tender (1)/not tender (0) giving a total possible TJC score of 0 to 28.|Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.||percent change||Standard Deviation|Mean
801778|NCT00977106|Secondary|Tender Joint Count (TJC) Based on 28-Joint Count During the Double-Blind Treatment Period|Twenty-eight joints were assessed for tenderness. Joints were classified as tender (1)/not tender (0) giving a total possible TJC score of 0 to 28. Baseline = value at Day 0 if available, value at screening otherwise.|Baseline and Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.||tender joints||Standard Deviation|Mean
801779|NCT00977106|Secondary|Hemoglobin Concentration During the Open Treatment Period|Hemoglobin concentrations were determined at each visit to evaluate anemia in participants and measured as g/dL.|Baseline, Weeks 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48|One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.||g/dL||Standard Deviation|Mean
803701|NCT00985673|Secondary|Number of Subjects Reporting Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling|During a 7-day follow-up period (Days 0-6) post-vaccination period|The Total Vaccinated cohort included all vaccinated subjects||Subjects|||Number
801781|NCT00977106|Secondary|FACIT-F During the Open Treatment Period|FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the patient's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-F score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the participant's health status. Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4.|Baseline, Weeks 12, 24, 36, and 48|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||units on a scale||Standard Deviation|Mean
801782|NCT00977106|Secondary|Percent Change From Baseline in FACIT-F During the Double-Blind Treatment Period|FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the patient's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-F score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the participant's health status. Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4.|Week 1 and Week 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||percent change||Standard Deviation|Mean
801783|NCT00977106|Secondary|Functional Assessment of Chronic Illness in Therapy - Fatigue (FACIT-F) During the Double-Blind Treatment Period|FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the patient's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-F score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the participant's health status. Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4.|Day 0, Week 1, and Week 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||units on a scale||Standard Deviation|Mean
801784|NCT00977106|Secondary|HAQ-DI During the Open Treatment Period|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline and Weeks 12, 24, 36, and 48|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.||units on a scale||Standard Deviation|Mean
801785|NCT00977106|Secondary|HAQ-DI During the Double-Blind Treatment Period|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Screening and Week 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||units on a scale||Standard Deviation|Mean
801786|NCT00977106|Secondary|Weekly Methotrexate (MTX) Dose|Before entering the study, participants had to be treated with MTX for at least 12 weeks and at a stable dose for at least 8 weeks before the screening visit (10-25 mg per week [mg/week] of oral or parenteral MTX). During the study, treatment with MTX had to be stable during the first month and then could be continued or modified, at the investigator’s discretion.|Baseline and Weeks 24 and 48|One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.||mg/week||Standard Deviation|Mean
801787|NCT00977106|Secondary|Serum Osteogenic Growth Peptide (s-OGP) Over the 1-Year Tocilizumab Period|S-OGP is a biological marker of bone and cartilage metabolism measured as picomoles per liter (pmol/L). Baseline is the closest value +/- 1 month around the first tocilizumab infusion. If values before and after the first infusion were eligible, the value before was taken into account.|Baseline and Weeks 12 and 48|One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.||pmol/L||Standard Deviation|Mean
801788|NCT00977106|Secondary|Serum Procollagen Type II N-Propeptide (s-PIINP), Serum Procollagen Type I N Propeptide (s-PINP), and Serum Carboxy-Terminal Collagen Crosslinks-1 (s-CTX-I) Over the 1-Year Tocilizumab Period|S-PIIINP, S-CTX-I, and S-PINP are biological markers of bone and cartilage metabolism. Baseline is the closest value +/- 1 month around the first tocilizumab infusion. If values before and after the first infusion were eligible, the value before was taken into account.|Baseline and Weeks 12, 24, and 48|One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.||ng/mL||Standard Deviation|Mean
801789|NCT00977106|Secondary|S-Sclerostin and P-Dkk1 (Wnt Signaling Inhibitor Dickkopf) Over the 1-Year Tocilizumab Period|S-Sclerostin and P-Dkk1 are biological markers of bone and cartilage metabolism measured as picograms/milliliter (pg/mL). Baseline is the closest value plus or minus (+/-) 1 month around the first tocilizumab infusion. If values before and after the first infusion were eligible, the value before was taken into account.|Baseline, Weeks 12, 24, and 48|One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.||pg/mL||Standard Deviation|Mean
801790|NCT00977106|Secondary|Percentage of Participants Treated With Corticosteroids Over the 1-Year Tocilizumab Period||Baseline, Weeks 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48|One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
801791|NCT00977106|Secondary|Bone Mineral Density|To describe bone mineral density (BMD), standardized values were calculated for lumbar spine, hip, femoral neck, and trochanter, taking into account the type of Dual energy X ray absorptiometry (DXA) used. All DXA at baseline were taken into account (done from before screening to Week 8). DXA at end of study were taken into account if they were done after at least 6 infusions of tocilizumab. Values were measured in milligrams per square centimeter (mg/cm^2).|Baseline and Week 48|One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.||mg/cm^2||Standard Deviation|Mean
801792|NCT00977106|Secondary|Percent Change From Baseline in Beta 2 Microglobulin Levels During the Double-Blind Treatment Period|Beta 2 Microglobulin is a biological marker of inflammation. If baseline value was equal to 0, it was replaced by 0.1 to calculate the change from baseline.|Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.||percent change||Standard Deviation|Mean
801793|NCT00977106|Secondary|Beta 2 Microglobulin Levels During the Double-Blind Treatment Period|Beta 2 Microglobulin is a biological marker of inflammation measured in micrograms per milliliter (mcg/mL).|Baseline, Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.||mg/L||Standard Deviation|Mean
801794|NCT00977106|Secondary|Beta 2 Microglobulin Levels During the Open Treatment Period|Beta 2 Microglobulin is a biological marker of inflammation measured in micrograms per milliliter (mcg/mL). Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4.|Baseline, Weeks 12, 24, 36, and 48|One-Year Efficacy Population;n=number of participants assessed for the specified parameter at a given visit.||mcg/mL||Standard Deviation|Mean
801795|NCT00977106|Secondary|Serum Amyloid A Component During the Open Treatment Period|Serum Amyloid A (SAA) component is a biological marker of inflammation measured in mg/L. Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4.|Baseline, Weeks 12, 24, 36, and 48|One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.||mg/L||Standard Deviation|Mean
801796|NCT00977106|Secondary|Percent Change From Baseline in Serum Amyloid A Component During the Double-Blind Treatment Period|Serum Amyloid A (SAA) component is a biological marker of inflammation. A negative change from baseline indicates improvement.|Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.||percent change||Standard Deviation|Mean
801797|NCT00977106|Secondary|Serum Amyloid A Component During the Double-Blind Treatment Period|Serum Amyloid A (SAA) component is a biological marker of inflammation and is measured in mg/L. A reduction in SAA indicates improvement.|Baseline, Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.||mg/L||Standard Deviation|Mean
801798|NCT00977106|Secondary|C- Reactive Protein During the Open Treatment Period|C-reactive protein is a biological marker of inflammation and is measured in nanograms per milliliter (ng/mL). Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4.|Baseline, Weeks 12, 24, 36, and 48|One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.||ng/L||Standard Deviation|Mean
801799|NCT00977106|Secondary|Percent Change From Baseline in C-Reactive Protein During the Double-Blind Treatment Period|C-Reactive protein (CRP) is a biological marker of inflammation. Negative changes from baseline indicate improvement.|Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.||percent change||Standard Deviation|Mean
801800|NCT00977106|Secondary|C-Reactive Protein During the Double-Blind Treatment Period|C-Reactive protein (CRP) is a biological marker of inflammation and is measured in nanograms per milliliter (ng/mL). A reduction in CRP indicates improvement.|Baseline, Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.||ng/mL||Standard Deviation|Mean
801801|NCT00977106|Secondary|Erythrocyte Sedimentation Rate During the Open Treatment Period|Erythrocyte sedimentation rate is a biological marker of inflammation, measured in mm/hr. A reduction in ESR indicates improvement. Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4.|Baseline, Weeks 12, 24, 36, and 48|One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.||mm/hr||Standard Deviation|Mean
801802|NCT00977106|Secondary|Percent Change From Baseline in Erythrocyte Sedimentation Rate During the Double-Blind Treatment|Erythrocyte sedimentation rate is a biological marker of inflammation. A negative change indicates improvement.|Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.||percent change||Standard Deviation|Mean
801803|NCT00977106|Secondary|Erythrocyte Sedimentation Rate During the Double-Blind Treatment Period|Erythrocyte sedimentation rate is a biological marker of inflammation, measured in mm per hour (mm/hr). A reduction in ESR indicates improvement.|Baseline, Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.||mm/hr||Standard Deviation|Mean
801823|NCT00977197|Secondary|Mean Diarrhea BSS Score at Week 12|The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.|Week 12|The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire.||units on a scale||Standard Deviation|Mean
801804|NCT00977106|Secondary|Percent Change From Baseline in Synovitis Score During the Open Treatment Period Assessed Using Power Doppler Ultrasound|Synovitis was assessed by ultrasonography (B-mode ultrasound and Power Doppler) and scored from “0” to “3”, for each of 40 joints (5 MCP [left and right] joints, 5 PIP [left and right] joints, left and right wrists, elbows, shoulders, knees, and ankles, and 5 MTP [left and right] joints); synovitis scores were calculated by adding the sum of scores for each joint for a total score ranging from 0 to 120 (higher score=more severe disease). Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4. Relative change was the percentage change from baseline.|Weeks 12, 24, and 48|One-Year Efficacy Population: all randomized participants with at least 1 tocilizumab infusion (completed or not). n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.||percent change||Standard Deviation|Mean
801805|NCT00977106|Secondary|Percent Change From Baseline in Synovitis Score During the Open Treatment Period Assessed Using B-Mode Ultrasound|Synovitis was assessed by ultrasonography (B-mode ultrasound and Power Doppler) and scored from “0” to “3”, for each of 40 joints (5 MCP [left and right] joints, 5 PIP [left and right] joints, left and right wrists, elbows, shoulders, knees, and ankles, and 5 MTP [left and right] joints); synovitis scores were calculated by adding the sum of scores for each joint for a total score ranging from 0 to 120 (higher score=more severe disease). Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4. Relative change was the percentage (%) change from baseline.|Weeks 12, 24, and 48|One-Year Efficacy Population: all randomized participants with at least 1 tocilizumab infusion (completed or not). n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.||percent change||Standard Deviation|Mean
801806|NCT00977106|Secondary|Synovitis Score During the Double-Blind Treatment Period Assessed Using Power Doppler Ultrasound|Synovitis was assessed by ultrasonography (B-mode ultrasound and Power Doppler) and scored from “0” to “3”, for each of 40 joints (5 MCP [left and right] joints, 5 PIP [left and right] joints, left and right wrists, elbows, shoulders, knees, and ankles, and 5 MTP [left and right] joints); synovitis scores were calculated by adding the sum of scores for each joint for a total score ranging from 0 to 120 (higher score=more severe disease). Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4. Negative change from baseline indicated improvement.|Baseline, Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.||units on a scale||Standard Deviation|Mean
801807|NCT00977106|Secondary|Synovitis Score During the Double-Blind Treatment Period Assessed Using B-Mode Ultrasound|Synovitis was assessed by ultrasonography (B-mode ultrasound and Power Doppler) and scored from “0” to “3”, for each of 40 joints (5 metacarpal phalangeal [MCP; left and right] joints, 5 proximal interphalangeal [PIP; left and right] joints, left and right wrists, elbows, shoulders, knees, and ankles, and 5 metatarsal phalangeal [MTP; left and right] joints); synovitis scores were calculated by adding the sum of scores for each joint for a total score ranging from 0 to 120. A score of 0 indicated no damage and a score of 120 indicated most severe damage. Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4. A negative change from baseline indicated improvement.|Baseline, Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.||units on a scale||Standard Deviation|Mean
801808|NCT00977106|Secondary|Patient Global Assessment of Pain During the Open Treatment Period|Participants were asked to rate their assessment of pain using a VAS of 0 to 100 mm, where 0 represented no pain and 100 represented intolerable pain. Participants were asked to mark the line corresponding to their assessment and the distance from the left edge was measured. A negative value in change from Baseline indicates an improvement.|Baseline and Weeks 12, 24, 36, and 48|ITT Population; 3 participants were randomized to the placebo treatment group but received tocilizumab. n=number of participants assessed at a specific visit||mm||Standard Deviation|Mean
801809|NCT00977106|Secondary|Patient Global Assessment of Pain During the Double-Blind Treatment Period|Participants were asked to rate their assessment of pain using a VAS of 0 to 100 mm, where 0 represented no pain and 100 represented intolerable pain. Participants were asked to mark the line corresponding to their assessment and the distance from the left edge was measured. A negative value in change from Baseline indicates an improvement.|Baseline and Week 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.||mm||Standard Deviation|Mean
801810|NCT00977106|Secondary|Physician Global Assessment of Disease Activity During the Open Treatment Period|Physicians were asked to assess disease activity of the participants using a VAS of 0 to 100 mm, where 0 represented no symptoms and 100 represented severe symptoms. Physicians were asked to mark the line corresponding to their assessment and the distance from the left edge was measured. A negative value in change from Baseline indicates an improvement.|Baseline, Weeks 12, 24, 36, and 48|ITT Population; 3 participants were randomized to the placebo treatment group but received tocilizumab. n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.||mm||Standard Deviation|Mean
801811|NCT00977106|Secondary|Physician Global Assessment of Disease Activity During the Double-Blind Treatment Period|Physicians were asked to assess disease activity of the participants using a VAS of 0 to 100 mm, where 0 represented no symptoms and 100 represented severe symptoms. Physicians were asked to mark the line corresponding to their assessment and the distance from the left edge was measured. A negative value in change from Baseline indicates an improvement.|Baseline and Week 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.||mm||Standard Deviation|Mean
811716|NCT01059760|Primary|Change From Baseline in Participant Glycogen-Like Protein-1 (GLP-1) When Fasting and Fed||Baseline and 3 days|||ng/mL||Standard Deviation|Mean
801812|NCT00977106|Secondary|Patient Global Assessment of Disease Activity During the Open Treatment Period|Participants were asked to rate their assessment of disease activity using a VAS of 0 to 100 mm, where 0 represented no symptoms and 100 represented severe symptoms. Participants were asked to mark the line corresponding to their assessment and the distance from the left edge was measured. A negative value in change from Baseline indicates an improvement.|Baseline, Weeks 12, 24, 36 and 48|ITT Population; 3 participants were randomized to the placebo treatment group but received tocilizumab. n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.||mm||Standard Deviation|Mean
801813|NCT00977106|Secondary|Patient Global Assessment of Disease Activity During the Double-Blind Treatment Period|Participants were asked to rate their assessment of disease activity using a visual analog scale (VAS) of 0 to 100 millimeters (mm), where 0 represented no symptoms and 100 represented severe symptoms. Participants were asked to mark the line corresponding to their assessment and the distance from the left edge was measured. A negative value in change from Baseline indicates an improvement.|Baseline, Weeks 1 and 4|ITT Population; number (n) = number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.||mm||Standard Deviation|Mean
801814|NCT00977106|Primary|Percentage of Participants With Clinically Significant Improvement in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 4|HAQ-DI includes 20 questions concerning participant’s activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant’s everyday activities: 0 (equals)=without difficulties; 1= with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3. Relevant clinical improvement was defined as a reduction of at least 0.22 points in HAQ-DI.|Week 4|ITT Population||percentage of participants|||Number
801815|NCT00977171|Primary|Patient Global Impression of Improvement|The CGI-I is a 7 point scale ranging from a score of 1 (very much improved) to 7 (very much worse), with no change in the middle, and assesses the improvement in relation to the baseline evaluation.|Baseline to end of 12 week treatment period|3 patients enrolled in the study prior to it being stopped due to difficulty enrolling patients.||units on a scale||Standard Deviation|Mean
801816|NCT00977184|Secondary|Activities of Daily Living UPDRS|The Activities of Daily Living Unified Parkinson's Disease Rating Scale (ADL UPDRS) is a self evaluation of the activities of daily living. The following variables are rated: speech, salivation, swallowing, handwriting, cutting food and handling utensils, dressing, hygiene, turning in bed, falling, freezing when walking, walking, tremor and sensory complaints. Each variable is rated on a scale of 0 (normal) to 4 (severe impairment). A total score for the ADL UPDRS ranges from 0 (no impairment) to 52 (severe impairment).|Baseline, 1 day post rTMS|Intent to treat||units on a scale||Standard Deviation|Mean
801817|NCT00977184|Secondary|Motor UPDRS|The Motor Unified Parkinson's Disease Rating Scale (UPDRS) includes only the motor assessment of the UPDRS (Part III) and examines speech, facial expression, tremor at rest, action tremor, rigidity, finger taps, hand movements, hand pronation and supination, leg agility, arising from chair, posture, gait, postural stability and body bradykinesia. The scores range from 0 (no motor impairment) to 108 (severe motor impairment). The Motor UPDRS was administered at baseline and at 1 day post rTMS or sham. Subjects were assessed on medication and off medication.|Baseline, 1 day post rTMS|Intent to treat.||units on a scale||Standard Deviation|Mean
801818|NCT00977184|Secondary|Total UPDRS Score|The Total Unified Parkinson's Disease Rating Scale (UPDRS) is an overall assessment scale that quantifies the signs and symptoms of Parkinson's disease. The total UPDRS score consists of mentation, behavior, mood, activities of daily living and motor components, and ranges from 0 (not affected) to 176 (most severely affected). The total UPDRS score is obtained from patient examination, interview and patient questionnaires.|Baseline, 1 day post rTMS|Intent to treat||units on a scale||Standard Deviation|Mean
801819|NCT00977184|Secondary|Bradykinesia|Bradykinesia refers to the slowness in executing a movement. Bradykinesia was assessed by measuring the time in seconds it takes to do the following sequence, 10 times: 1) hand closing and opening while squeezing a ball 2) elbow flexion 3) hand closing and opening, and 4) elbow extension. Subjects were allowed to practice these hand and arm movements until performance appeared not to get faster, and then abstained from further practice to minimize learning effects. The time it takes subjects to execute the entire sequence 10 times with either the left or right arm/hand was measured. Means are reported for each group.|Baseline, 1 day post rTMS|||seconds||Standard Deviation|Mean
801820|NCT00977184|Primary|Gait Speed|Gait speed was assessed by measuring the time it takes to walk 10 meters. Subject's gait speed was measured while on medication and off medication for each group, i.e., real rTMS and sham rTMS. Two trials were averaged for each condition. Patients were instructed to walk fast without taking the risk of falling, wearing the same shoes and consistently using assistive devices if needed. Gait speed was measured at baseline and 1 day post intervention.|Baseline, 1 day post rTMS|Intent to treat||seconds||Standard Deviation|Mean
801821|NCT00977197|Secondary|Number of Subjects With Greater Than or Equal to a 30 Point Change in Pain BSS Score|The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.|baseline, week 12|Intent to Treat analysis||participants|||Number
801822|NCT00977197|Secondary|Mean Bloating BSS Score at Week 12|The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.|Week 12|The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire.||units on a scale||Standard Deviation|Mean
804368|NCT00997555|Secondary|Length of Mechanical Ventilation|Days of mechanical ventilation (bronchoscopy 5.1 days, 95% CI +/- 3.6 days versus control 6.7 days, 95% CI +/- 6.3 days, p = 0.7).|until discharge from hospital, data reviewed every 6 months|||days||95% Confidence Interval|Median
801824|NCT00977197|Secondary|Mean Constipation BSS Score at Week 12|The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.|Week 12|The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire.||units on a scale||Standard Deviation|Mean
801825|NCT00977197|Secondary|Mean Overall Severity BSS Score at Week 12|The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.|Week 12|The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire.||units on a scale||Standard Deviation|Mean
801826|NCT00977197|Secondary|Mean Pain BSS Score at Week 12|The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.|Week 12|The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire.||units on a scale||Standard Deviation|Mean
801827|NCT00977197|Secondary|Number of Subjects With Adequate Relief of IBS Symptoms at Least 50% of the Last 4 Weeks of Therapy|"One of the weekly questions asked of subjects was, Did you have adequate relief of your IBS symptoms over the last week? Possible answers were Yes or No."|Weeks 9-12|Intent to treat analysis||participants|||Number
801828|NCT00977197|Secondary|Mean Bloating BSS Score Over the Last 4 Weeks of the Study (Weeks 9-12)|The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.|Weeks 9-12)|The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire.||units on a scale||Standard Deviation|Mean
801829|NCT00977197|Secondary|Mean Diarrhea BSS Score Over the Last 4 Weeks of the Study (Weeks 9-12)|The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.|Weeks 9-12|The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire.||units on a scale||Standard Deviation|Mean
801830|NCT00977197|Secondary|Mean Constipation BSS Score Over Last 4 Weeks of Study (Weeks 9-12)|The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.|Weeks 9-12|The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire.||units on a scale||Standard Deviation|Mean
801831|NCT00977197|Secondary|Mean Overall Severity of Irritable Bowel Syndrome (IBS) Symptoms BSS Score Last 4 Weeks of the Study (Weeks 9-12)|The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.|weeks 9-12|The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire.||units on a scale||Standard Deviation|Mean
801832|NCT00977197|Primary|Mean Pain Bowel Symptom Scale (BSS) Score Over Last 4 Weeks of Study (Weeks 9-12)|The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.|weeks 9-12|Intent to treat analysis||units on a scale||Standard Deviation|Mean
801833|NCT00977314|Secondary|Measure of Benefit of SoundBite Using Abbreviated Profile of Hearing Aid Benefit (APHAB).|The measure of the benefit of the device was assessed using the Abbreviated Profile of Hearing Aid Benefit (APHAB), a 24-item self-assessment inventory in which the amount of difficulty in everyday situations is reported with larger numbers indicating more difficulty. Device benefit is calculated by subtracting the score obtained after using a device from the score obtained before using the device. A software program is utilized to score the APHAB and results are compared a different time points. The APHAB is well characterized and broadly used as a quantifiable measurement of device benefit. The APHAB benefit scores can range from -99 (treatment worse than no treatment) to +99 (treatment better than no treatment)|30 days|||Global Benefit Score||Standard Deviation|Mean
801902|NCT00977938|Secondary|MACCE (Death, Myocardial Infarction or Stroke) - Randomized BMS ITT||21 months (12-33 months post-index procedure)|All randomized BMS ITT patients; Patients were analyzed according to the treatment to which they were randomized (regardless of post-randomization compliance with the randomized treatment); Patients not experiencing the endpoint were censored at 33 months or at last known follow-up, whichever was earlier.||percentage of patients (KM estimate)|||Number
801834|NCT00977314|Primary|Efficacy: Ability to Understand Speech in Noise|The primary efficacy outcome was a measure of the ability to understand speech in noise while wearing the device compared with not wearing the device. The Hearing in Noise Test (HINT) was utilized for this measure as it is the most widely used test for SSD devices. An improvement in HINT score is indicated as a negative (-) dB value change. A more negative (-dB) value indicates an improvement in understanding speech in noise. An improvement in a HINT score of -1 dB is equivalent to a 10% improvement in the ability to understand speech in noise and is likely of clinical benefit. The scores are calculated as HINT Advantage (aided compared with unaided) which depict the differences of using a device as compared to not wearing a device.|Day 1, Day 30|||dB||Standard Deviation|Mean
801835|NCT00977314|Primary|Incidence of Device- and Procedure-related Adverse Events at 30 Days|"The safety parameters for the trial were monitored throughout the Evaluation Phase (30 days). The safety checks included:
Comprehensive Medical evaluation at Enrollment and at Termination Comprehensive Dental evaluation at Enrollment and at Termination, with interim dental checks at each visit in between, if needed Comprehensive Audiological evaluation at Enrollment and Termination."|30 days|||participants|||Number
801836|NCT00977379|Secondary|Absolute Change From Baseline in Mini Mental State (MMS) Total Score|MMS was an 11-question measure that tested five areas of cognitive function: orientation, registration, attention and calculation, recall, and language. Four items were scored on a scale of 0 to 1; 1 item was scored on a scale of 0 to 2; 3 items were scored on a scale of 0 to 3; and 3 items were scored on a scale of 0 to 5. MMS total score was obtained by adding the scores of all individual items and ranged from 0 to 30, where higher scores indicate better cognitive state.|Baseline, Up to end of Treatment (up to 10.6 months overall)|ITT population. Here, number of participants analyzed = participants evaluable for this outcome.||units on a scale||Standard Deviation|Mean
801837|NCT00977379|Secondary|Overall Survival (OS)|OS was defined as the time from the start of study treatment to date of death due to any cause. OS was assessed using Kaplan-Meier analysis.|Baseline until death (up to approximately 1 year 5.5 months overall)|ITT population.||months||95% Confidence Interval|Median
801838|NCT00977379|Secondary|Time to Progression, Assessed by Investigator According to MRI and CT|Time to progression was defined as the time from start of study treatment to first documentation of PD or death due to tumor (CNS or extra-cranial). PD was assessed by MRI or CT according to RECIST. PD: a 20% or greater increase in the sum of the LD of CNS or extra-cranial lesions taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more CNS or extra-cranial lesions and/or unequivocal progression of existing CNS or extra-cranial lesions.|Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm “WBRT Followed by Standard of Care” only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)|ITT population.||months||Full Range|Median
801839|NCT00977379|Secondary|Time to Extra-cranial Disease Progression, Assessed by Investigator According to CT|Time to extra-cranial progression was defined as the time from start of study treatment to first documentation of PD or death due to extra-cranial lesions. PD was assessed by CT according to RECIST. PD: a 20% or greater increase in the sum of the LD of extra-cranial lesions taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more extra-cranial lesions and/or unequivocal progression of existing extra-cranial lesions.|Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm “WBRT Followed by Standard of Care” only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)|ITT population.||months||Full Range|Median
801840|NCT00977379|Secondary|Percentage of Participants With Objective Extra-cranial Disease Response at 4 Weeks After Completion of WBRT, Assessed by Investigator According to CT|Objective extra-cranial response was defined as having CR or PR for extra-cranial lesions, assessed by CT using RECIST. CR: disappearance of all extra-cranial lesions. PR: >/=30 % decrease in sum of LD of extra-cranial lesions taking as reference the baseline sum LD.|Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm “WBRT Followed by Standard of Care” only), or death, whichever occurred first up to 4 weeks after completion of WBRT (up to approximately 7 weeks)|ITT population.||percentage of participants|||Number
801841|NCT00977379|Secondary|Percentage of Participants With Best Objective Extra-cranial Disease Response, Assessed by Investigator According to Computed Tomography (CT)|Best objective extra-cranial response was defined as having CR or PR for extra-cranial lesions, assessed by CT using RECIST. CR: disappearance of all extra-cranial lesions. PR: >/=30 % decrease in sum of LD of extra-cranial lesions taking as reference the baseline sum LD.|Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm “WBRT Followed by Standard of Care” only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)|ITT population.||percentage of participants|||Number
801842|NCT00977379|Secondary|Time to CNS Progression, Assessed by Investigator According to MRI|Time to CNS progression was defined as the time from start of study treatment to first documentation of PD or death due to CNS metastasis. PD was assessed by contrast-enhanced MRI according to RECIST. PD: a 20% or greater increase in the sum of the LD of CNS lesions taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more CNS lesions and/or unequivocal progression of existing CNS lesions.|Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm “WBRT Followed by Standard of Care” only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)|ITT population.||months||Full Range|Median
801843|NCT00977379|Secondary|Duration of CNS Response, Assessed by Investigator According to MRI|Duration of CNS response was defined as the time from first documented cranial CR or PR (whichever was recorded first) until the first date CNS recurrence or progression was documented as assessed by contrast-enhanced MRI according to RECIST criteria but without exam for response confirmation. CR: disappearance of all CNS lesions. PR: >/=30 % decrease in sum of LD of CNS lesions taking as reference the baseline sum LD. PD: a 20% or greater increase in the sum of the LD of CNS lesions taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more CNS lesions and/or unequivocal progression of existing CNS lesions.|Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm “WBRT Followed by Standard of Care” only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)|ITT population. Here, number of participants analyzed = participants having had a CR or PR during the study.||months||Full Range|Median
801844|NCT00977379|Secondary|Percentage of Participants With Objective CNS Response at 4 Weeks After Completion of WBRT, Assessed by Investigator According to MRI|Objective CNS response was defined as having CR or PR for CNS metastasis, assessed by contrast-enhanced MRI using RECIST. CR: disappearance of all CNS lesions. PR: >/=30 % decrease in sum of LD of CNS lesions taking as reference the baseline sum LD.|Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm “WBRT Followed by Standard of Care” only), or death, whichever occurred first up to 4 weeks after completion of WBRT (up to approximately 7 weeks)|ITT population.||percentage of participants|||Number
801845|NCT00977379|Secondary|Percentage of Participants With Clinical Benefit, Assessed by Investigator According to MRI|Clinical benefit was defined as having CR, PR, or stable disease (SD), assessed by contrast-enhanced MRI using RECIST. CR: disappearance of all CNS lesions. PR: >/=30 % decrease in sum of LD of CNS lesions taking as reference the baseline sum LD. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference smallest sum LD since treatment started. PD: a 20% or greater increase in the sum of the LD of CNS lesions taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more CNS lesions and/or unequivocal progression of existing CNS lesions.|Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm “WBRT Followed by Standard of Care” only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)|ITT population.||percentage of participants|||Number
801846|NCT00977379|Secondary|Percentage of Participants With Objective CNS Response at 4 Weeks After Completion of WBRT, Assessed by Centralized Independent Expert According to MRI in 3 Dimension|Objective CNS response was defined as having CR or PR for CNS metastasis, assessed by 3 dimensional MRI using RECIST. CR: disappearance of all CNS lesions. PR: >/=30% decrease in sum of LD of CNS lesions taking as reference the baseline sum LD.|Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm “WBRT Followed by Standard of Care” only), or death, whichever occurred first up to 4 weeks after completion of WBRT (up to approximately 7 weeks)|The data for this outcome was not collected as per changes in planned analysis because sufficient information on the method used was not available.|||||
801847|NCT00977379|Secondary|Percentage of Participants With Best Objective CNS Response, Assessed by Investigator According to MRI|Best objective CNS response was defined as having CR or PR for CNS metastasis, assessed by contrast-enhanced MRI using RECIST. CR: disappearance of all CNS lesions. PR: >/=30% decrease in sum of LD of CNS lesions taking as reference the baseline sum LD.|Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm “WBRT Followed by Standard of Care” only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)|ITT population.||percentage of participants|||Number
801848|NCT00977379|Secondary|Percentage of Participants With Objective CNS Response at 4 Weeks After Completion of WBRT, Assessed by Centralized Independent Expert According to MRI|Objective CNS response was defined as having CR or PR for CNS metastasis, assessed by contrast-enhanced MRI using RECIST. CR: disappearance of all CNS lesions. PR: >/=30% decrease in sum of LD of CNS lesions taking as reference the baseline sum LD.|Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm “WBRT Followed by Standard of Care” only), or death, whichever occurred first up to 4 weeks after completion of WBRT (up to approximately 7 weeks)|ITT population.||percentage of participants|||Number
801849|NCT00977379|Primary|Percentage of Participants With Best Objective CNS Response, Assessed by Centralized Independent Expert According to MRI - Per-Protocol (PP) Population|Best objective CNS response was defined as having CR or PR for CNS metastasis, assessed by contrast-enhanced MRI using RECIST. CR: disappearance of all CNS lesions. PR: >/=30% decrease in sum of LD of CNS lesions taking as reference the baseline sum LD.|Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm “WBRT Followed by Standard of Care” only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)|PP population included all ITT population participants excluding participants with following major protocol violations: inclusion and exclusion criteria not met; intake of prohibited treatment, protocol design and/or visit dates not respected; and missing values for main criterion without premature withdrawal.||percentage of participants|||Number
801850|NCT00977379|Primary|Percentage of Participants With Best Objective Central Nervous System (CNS) Response, Assessed by Centralized Independent Expert According to Magnetic Resonance Imaging (MRI) - Intent-to-Treat (ITT) Population|Best objective CNS response was defined as having complete response (CR) or partial response (PR) for CNS metastasis, assessed by contrast-enhanced MRI using response evaluation criteria in solid tumors (RECIST). CR: disappearance of all CNS lesions. PR: greater than or equal to (>/=) 30 percent (%) decrease in sum of longest diameters (LD) of CNS lesions taking as reference the baseline sum LD.|Baseline until disease progression (PD), unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm “WBRT Followed by Standard of Care” only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)|ITT population.||percentage of participants|||Number
801851|NCT00977470|Other Pre-specified|Percent of Participants in Which FMISO-PET ([18F]-Fluoromisonidazole-positron Emission Tomography) is Able to Detect and Quantify Changes in Tumor Hypoxia After Erlotinib.|[18F]-FMISO-PET/CT was performed on a 64-slice PET/CT scanner and tracer uptake was assessed using SUV (standardized uptake value), normalizing the radioactivity measured in tissue by the injected dose and the body weight of the patient. Mean and maximum SUV and threshold volume of FMISO uptake were measured to quantify the extent of hypoxia in the primary tumor. Imaging was performed before and after initiation of therapy with erlotinib.|12 weeks|Only 2 participants were enrolled in this pilot companion study||Participants|||Count of Participants
801852|NCT00977470|Other Pre-specified|EGFR Mutational Status|Correlation of molecular and genetic tumor characteristics with disease response. Genomic DNA will be extracted from tumor tissue and direct sequencing analysis will be performed to identify additional mutations.|2 years|Tumor tissue analysis was not performed for this correlative outcome.|||||
801853|NCT00977470|Other Pre-specified|Circulating Tumor Cell Quantification|Serial circulating tumor cell (CTC) analyses will be performed on peripheral blood and correlated with disease response.|Until disease progression (median of 10.8 months)|Due to technical reasons, this assay was not ready and therefore circulating tumor cell analysis was not done.|||||
801854|NCT00977470|Secondary|Overall Survival of Patients Treated With Erlotinib and With Erlotinib/HCQ||Until death||01/2018||||
801855|NCT00977470|Secondary|Objective Tumor Response Rate Following Treatment With Erlotinib and With Erlotinib/HCQ.|"Response is assessed via spiral CT scan, done at baseline and after every 2 cycles of study treatment. Standard RECIST (Response Evaluation Criteria in Solid Tumors) was used. Complete Response (CR) = disappearance of all target lesions; Partial Response (PR) = at least a 30% decrease in the size of target lesions, as compared to baseline; Progressive Disease (PD) = at least at 20% increase in the size of target lesions, or the appearance of one or more new lesions; Stable Disease (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease.
Response rate = CR + PR. Disease control rate = CR + PR + SD"|2 years|1 participant in each arm (2 participants total) did not have any scans done after baseline and therefore response could not be assessed.||Participants|||Count of Participants
801856|NCT00977470|Secondary|Treatment Related Toxicity, > 10% Frequency, Any Grade|To evaluate the safety of treatment with erlotinib with and without hydroxychloroquine (HCQ). All participants receiving study treatment were evaluated for safety. Parameters included laboratory tests, hematological abnormalities, physical exam findings and spontaneous reports of adverse events reported by participants. Toxicities were evaluated and graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening, Grade 5 = fatal.|2 years|||Participants|||Count of Participants
801857|NCT00977470|Primary|Nine-month Progression-free Survival Rate|This trial can detect a difference in proportions alive without progression at 9 months from 50% in the erlotinib arm to 77% in the erlotinib plus hydroxychloroquine (HCQ) arm, using an alpha of 0.15 and power of 85%, using the two-sided Likelihood Ratio test. Progression is defined as at least a 20% increase in the size of existing lesions or the appearance of one or more new lesions.|Nine months|||percentage of participants||95% Confidence Interval|Number
801858|NCT00977470|Primary|Median Progression Free Survival|A measure of progression-free survival in patients with advanced non small-cell lung cancer (NSCLC) and EGFR mutations treated with erlotinib as compared with patients treated with erlotinib plus hydroxychloroquine (HCQ). Disease progression is defined as at least a 20% increase in the sum of the longest diameter of target lesions, as seen on CT scan, or the appearance of one or more new lesions on CT scan.|From start of treatment until report of disease progression, assessed up to 10 years.|||months||Full Range|Median
801859|NCT00977548|Secondary|Leukemia Free Survival (LFS)|LFS: Survival without evidence of relapse at any time post-transplant. Kaplan-Meier estimates were used for secondary endpoint analysis.|Up to 21 Months|All evaluable participants. Nine patients were not evaluable for response (withdrew consent or off study due to adverse event before first evaluation).||months||95% Confidence Interval|Median
801860|NCT00977548|Secondary|Median Progression Free Survival (PFS)|PFS: The time elapsed between treatment initiation and tumor progression or death from any cause. Kaplan-Meier estimates were used for secondary endpoint analysis. Disease Progression is defined using International Working Group (IWG) Response Criteria for MDS, as at least 50% decrement from maximum remission/response levels in granulocytes or platelets; reduction in hemoglobin (Hgb) concentration by ≥ 2 g/dL; transfusion dependence.|Up to 21 Months|All evaluable participants. Nine patients were not evaluable for response (withdrew consent or off study due to adverse event before first evaluation).||months||95% Confidence Interval|Median
801861|NCT00977548|Secondary|Median Overall Survival (OS)|OS: The time from randomization until death from any cause. Kaplan-Meier estimates were used for secondary endpoint analysis.|Up to 21 Months|All evaluable participants. Nine patients were not evaluable for response (withdrew consent or off study due to adverse event before first evaluation).||months||95% Confidence Interval|Median
801862|NCT00977548|Primary|Combined Overall Response Rate (ORR)|Best Response Categories: Marrow complete response (CR), Bone marrow: ≤ 5% myeloblasts and decrease by ≥ 50% over pretreatment; Hematological improvement (HI), Hgb increase by ≥ 1.5 g/dL, Absolute increase of ≥ 30 x 10^9/L for patients starting with > 20 x 10^9/L, At least 100% increase and an absolute increase of > 0.5 x 10^9/L, as defined by the International Working Group (IWG) 2006 criteria.|Up to 21 Months|All evaluable participants. Nine patients were not evaluable for response (withdrew consent or off study due to adverse event before first evaluation).||participants|||Number
801863|NCT00977561|Secondary|Number of Total Circulating Tumor-Related Cells (CTCs) and Insulin-Like Growth Factor 1 Receptor (IGF-IR)-Expressing CTCs|Pre-treatment and post-treatment counts of total and IGF-IR-positive CTCs|Baseline (Cycle 1, Day 1), Cycle 4 (Day 1) and at the end of treatment visit (28 days post last figitumumab dose)|No analysis of total CTCs and IGF-IR-expressing CTCs was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.|||||
801864|NCT00977561|Secondary|Levels of Serum Circulating Insulin-like Growth Factor (IGF) Pathway Related Markers||Baseline (Cycle 1, Day 1 prior to dosing), Cycle 4 (Day 1), at the end of treatment visit (28 days post last figitumumab dose)|No analysis for serum circulating IGF pathway related markers was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.|||||
801865|NCT00977561|Secondary|Pre-treatment Levels of Tumor Biomarkers Involved in Insulin-Like Growth Factor 1 (IGF-I) Signaling Pathway||Baseline prior to dosing|No analysis of tumor biomarkers was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.|||||
801866|NCT00977561|Secondary|Numeric Rating Scale (NRS) Score|"The Numeric Rating Scale (NRS) is a 1-item self-reported questionnaire designed to assess worst pain severity. Overall scores range from 0 to 10, with low scores representing a lower level of pain."|Day 1 of every cycle (up to 17 cycles), at the end of treatment visit (28 days post last dose); then every 6 weeks until disease progression|No analysis for NRS score was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.|||||
804369|NCT00997555|Secondary|Incidence of Pneumonia|Bronchoscopy group- 4/13 (31%) Control group- 6/15 (40%)|until discharge from the hospital, data reviewed every 6 months|||participants|||Number
801867|NCT00977561|Secondary|Cancer Dyspnea Scale (CDS) Score|"The Cancer Dyspnea Scale consists of 12 questions that assess 3 domains of dyspnea (sense of effort, anxiety and discomfort) related to lung cancer. The questions are answered on 5-point Likert scale ranging from 1 to 5 (1 Not at All to 5 Very Much)."|Day 1 of every cycle (up to 17 cycles), at the end of treatment visit (28 days post last dose); then every 6 weeks until disease progression|No analysis for cancer dyspnea scale score was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.|||||
801868|NCT00977561|Secondary|Percentage of Participants Reporting Positive Anti-Drug Antibodies (ADA) Response for Figitumumab|Percentage of participants with positive total or neutralizing anti-drug antibody (ADA) for figitumumab|Day 2 of Cycle 1 (or Day 1 of the initial cycle starting single agent figitumumab); Day 1 of Cycles 2 and 4; Day 28 and Day 90 post last figitumumab dose|No analysis of ADA response was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.|||||
801869|NCT00977561|Secondary|Maximum Observed Plasma Concentration (Cmax) of Etoposide||Cycles 1 and 2, Day 1 and Day 2 (within 3 hours prior to Day 1 etoposide infusion; 1, 1.5, 2, 3, 6, and 24 hours post Day 1 etoposide infusion); Cycles 4 and 5, Day 2: 24 hours post Day 1 etoposide infusion|No analysis of PK parameters for etoposide was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.|||||
801870|NCT00977561|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Etoposide|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|Cycles 1 and 2, Day 1 and Day 2 (within 3 hours prior to Day 1 etoposide infusion; 1, 1.5, 2, 3, 6, and 24 hours post Day 1 etoposide infusion); Cycles 4 and 5, Day 2: 24 hours post Day 1 etoposide infusion|No analysis of pharmacokinetics (PK) parameters for etoposide was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.|||||
801871|NCT00977561|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) of Figitumumab||Cycle 1, Day 2; Day 1 of Cycles 2, 4, 5, 6, 10 and 15; Day 28 and Day 90 post last figitumumab dose|No analysis of Cmin for figitumumab was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.|||||
801872|NCT00977561|Secondary|Maximum Observed Plasma Concentration (Cmax) of Figitumumab||Cycle 1, Day 2; Day 1 of Cycles 2, 4, 5, 6, 10 and 15; Day 28 and Day 90 post last figitumumab dose|No analysis of Cmax for figitumumab was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.|||||
801873|NCT00977561|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|AEs are any untoward, undesired, or unplanned event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study treatment. The event does not need to be causally related to the study treatment. SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly or birth defect in the offspring of a study subject.|Baseline up to follow-up (90 days post dose)|All randomized participants who received at least one dose of any agent of the combination were included in the safety analysis.||participants|||Number
801874|NCT00977561|Secondary|Overall Survival (OS)|Overall survival was the duration from enrollment to death due to any cause. For participants who are alive, overall survival was censored at the last contact. Survival time (days) = [death date (last known alive date) - date of randomization +1].|Every 3 months until death or 12 months from the date the last participant was randomized|No analysis of overall survival was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.|||||
801875|NCT00977561|Secondary|Number of Participants With Objective Response|Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST.|Baseline, every 2nd cycle (between Day 15-21, 1 cycle = 21 days) starting with Cycle 2 until disease progression, at the end of treatment visit (if more than 28 days have passed since last evaluation); and every 6 weeks until disease progression|No analysis of objective response was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.|||||
801876|NCT00977561|Primary|Progression-Free Survival (PFS)|Median time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first. PFS time (days) = [event (progression or death) date or censor date - date of randomization + 1].|Baseline, every 2nd cycle (between Day 15-21, 1 cycle = 21 days) starting with Cycle 2 until disease progression, at the end of treatment visit (if more than 28 days have passed since last evaluation); and every 6 weeks until disease progression|No analysis of progression-free survival was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.|||||
801877|NCT00977613|Secondary|Overall Survival||after 6 months||||||
801878|NCT00977613|Secondary|Recurrence-free Survival||after 6 months||||||
801879|NCT00977613|Secondary|Disease-free Survival||after 6 months||||||
801880|NCT00977613|Primary|Number of Participants Who Maintained an Exercise Regimen Average of 18 Metabolic Units (MET) Per Week or Greater|One MET is the energy expenditure for sitting quietly for 1 hour. MET scores for walking were assigned based on the pace and duration reported. For other activities, a leisurely to moderate intensity score was selected. The scores for MET-hours per week for each activity were calculated from the reported hours per week engaged in that activity multiplied by the assigned MET score, and individual activities were summed to derive a total MET-hours per week.|6 months|34 of the 50 enrolled subjects had at least 6 months of follow-up. There was no evaluable data for the remaining 16 subjects.||participants|||Number
801881|NCT00977665|Secondary|Total Number of Falls During the Study|Participants recorded each time they fell during the study in a diary.|Day 1 up to week 48|Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment, and who maintained diaries.||falls||Inter-Quartile Range|Median
801882|NCT00977665|Secondary|Change From Baseline to Week 48 or Termination in the Beck Depression Inventory Scale (BDI-II)|The Beck Depression Inventory (BDI-II), is a 21-question multiple-choice self-report inventory, one of the most widely used instruments for measuring the severity of depression. Participants are asked to pick the answer for each question that best describes the way they have been feeling in the past two weeks, including the day participants complete the questionnaire. Each question is rated on a scale of 0-3, with 0 meaning the participant does not feel the emotion described in the question, and 3 meaning the participant has extremely strong feelings. Total scale is 0 (no evidence of depression) to 63 (extreme depression). Negative change from baseline scores indicate improvement in level of depression.|Day 0 (baseline), Week 48 or termination visit|Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
801883|NCT00977665|Secondary|Percentage of Participants Who Achieved a Score of >=3 on the Unified Multiple System Atrophy Rating Scale (UMSARS) Question #1 (Speech Impairment), Question #2 (Swallowing Impairment) and Question #8 (Falling)|"UMSARS' questions are rated on a scale of 0=normal to 4=extreme impairment.
This endpoint reports the percentage of participants rated a 3 or worse. Rating 3 = Severely impaired speech (Question #1), swallowing (Question #2) or falling more frequently than once per week (Question #8)."|up to week 48|Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment.||percentage of participants|||Number
801884|NCT00977665|Secondary|Change From Baseline to Week 48 or Termination in the Montreal Cognitive Assessment Scale (MoCA) Scale|MoCA is a cognitive screening test which helps health professionals identify mild cognitive impairment. The total scale is 0 (significant cognitive impairment) to 30 (no impairment detected). Scores >=26 are considered normal. Positive change from baseline scores indicate improvement in cognition.|Day 0 (baseline), Week 48 or termination visit|Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
801885|NCT00977665|Secondary|Estimates for Time to Change in Anti-Parkinsonian or Anti-Orthostatis Hypotension Medications|"Change in anti-parkinsonian or anti-orthostatic hypotension medication is defined by at least one of the following events:
An addition of a new anti-parkinsonian or anti-orthostatic hypotension medication during study.
Dose modification of anti-parkinsonian or anti-orthostatic hypotension concomitant medications reflecting disease progression.
The event of interest, determined on a by patient basis, therefore, is the earliest event of the two events defined above. Otherwise, patient is right censored according to his/her study termination date.
Since less than 25% of participants had an event, median estimatation for time to change in medications is not possible."|Day 0 (baseline) to Week 48 or termination visit|Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment.||days||95% Confidence Interval|Median
801886|NCT00977665|Secondary|Change From Baseline to Week 12 in Total UMSARS Score for Symptomatic Effect|This outcome represents the sum of 2 UMSARS sub-scales: Part I: Historical Review that includes 12 items and Part II: Motor Examination that includes 14 items. All items range from 0 to 4. Each subscale score is the sum of its items and the total UMSARS score is the sum of all 26 items. Hence the total UMSARS score can range from 0 to 104, with 0 meaning no impairment and 104 indicating severe impairment. Negative change from baseline scores indicate improvement.|Day 0 (baseline), Week 12|Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment.||units on a scale||Standard Deviation|Mean
801887|NCT00977665|Secondary|Change From Baseline to Week 48 or Termination in UMSARS Subscores for Parts I, II and IV|UMSARS Part I is an historical review and scores symptoms of neurological and autonomic dysfunction with 12 items rated on a scale of 0 (normal) to 4 (extreme dysfunction). The full scale for Part 1 is therefore 0 (normal) to 48 (extreme dysfunction). Part II is a motor examination and has 14 items also rated on a scale of 0 to 4 for a full scale of 0 (normal) to 56 (extreme dysfunction). Part IV is a global disability scale with rates the extent of disease from 1 (normal) to 5 (severe disease).|Day 0 (baseline), Week 48 or termination visit|Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
801888|NCT00977665|Secondary|Rate of Progression in Total Unified Multiple System Atrophy Rating Scale (UMSARS) Score From Baseline to Weeks 12-48|"The UMSARS is composed of 2 sub-scales: Part I: Historical Review that includes 12 items and Part II: Motor Examination that includes 14 items. All items range from 0 to 4. Each subscale score is the sum of its items and the total UMSARS score is the sum of all 26 items. Hence the total UMSARS score can range from 0 to 104, with 0 meaning no impairment and 104 indicating severe impairment.
The rate of progression of atrophy is represented by the slope of change from baseline scores for visits between Weeks 12 and 48."|Day 0 (baseline), Weeks 12-48|Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment.||units on a scale/week||Standard Error|Mean
801986|NCT00978757|Primary|The Effect of Ketamine on Interleukin 6 Synthesis in Hepatic Resections Requiring Temporary Porto-arterial Occlusion (Pringle Maneuver)||Blood samples for IL-6 levels were obtained prior to surgery, upon placement of the first intravenous|||pg/ml||Standard Deviation|Mean
801889|NCT00977665|Secondary|Change From Baseline to Week 48/Termination Visit in the Multiple System Atrophy (MSA) Health-related Quality of Life (QoL) Scale|"The Multiple System Atrophy Quality of Life questionnaire (MSA-QoL) is a self-reported questionnaire focusing on MSA-specific symptoms and has a scale ranging from 0 - 160, with 0= 'no problem' and 160= extreme problem."|Day 0 (baseline), Week 48|Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
801890|NCT00977665|Secondary|Mean Score of the Composite Autonomic Symptom Scale Select (COMPASS_Select Change) at Week 48/Termination Visit|COMPASS_Select change is comprised of 5 of the 11 domains in the COMPASS scale: Orthostatic Intolerance, Bladder Disorder, Sweating, Vasomotor, and Sleep Disorder COMPASS_Select change has a range of -150 to 150, with -150 indicating symptoms are much better and 150 indicating symptoms are much worse.|48 weeks|Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
801891|NCT00977665|Secondary|Percentage of Participants Who Achieved a Score of >=3 on the Unified Multiple System Atrophy Rating Scale (UMSARS) Question #7 Regarding Ambulation|UMSARS' Question #7 concerns the participant's ability to walk, rated on a scale of 0=normal to 4=cannot walk at all even with assistance. This endpoint counts participants rated a 3 or worse. Rating 3 = Severely impaired; assistance and/or walking aid needed occasionally.|up to week 48|Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment.||percentage of participants|||Number
801892|NCT00977665|Secondary|Change From Baseline to Week 24 in Total Unified Multiple System Atrophy Rating Scale (UMSARS) Score|"The UMSARS is composed of 2 sub-scales: Part I: Historical Review that includes 12 items and Part II: Motor Examination that includes 14 items. All items range from 0 to 4. Each subscale score is the sum of its items and the total UMSARS score is the sum of all 26 items. Hence the total UMSARS score can range from 0 to 104, with 0 meaning no impairment and 104 indicating severe impairment. Negative change from baseline scores indicate improvement.
In the case that 6 items or more (out of 26) were missing at a certain visit, the UMSARS score for that visit was assigned a missing value."|Day 0 (baseline), Week 24|Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
801893|NCT00977665|Secondary|Clinical Global Impression Improvement (CGI-I) at Week 48/Termination Visit|"Outcome measures the investigator's clinical impression of the participants' improvement at Week 48 as compared to Week 12. CGI scale range from 1-7, with 1=very much improved, 4= no change, and 7=very much worse.
In order to maintain the overall (hypotheses about primary and key secondary endpoints) type I error at the 0.05 level an hierarchy will be employed as follows: If the primary endpoint will be found to be significant at a significance level of 0.05 then the first key secondary endpoint will be tested, if this endpoint will be found to be significant in a significance level of 0.05 then the second key secondary endpoint will be tested and so on. The 'key' secondary endpoints are outcomes 2-6."|Week 48|Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
801894|NCT00977665|Primary|Change From Baseline to Week 48/Termination Visit in the Total Unified Multiple System Atrophy Rating Scale (UMSARS Part I and II)|"This outcome represents the sum of 2 UMSARS sub-scales: Part I: Historical Review that includes 12 items and Part II: Motor Examination that includes 14 items. All items range from 0 to 4. Each subscale score is the sum of its items and the total UMSARS score is the sum of all 26 items. Hence the total UMSARS score can range from 0 to 104, with 0 meaning no impairment and 104 indicating severe impairment. Negative change from baseline scores indicate improvement.
In the case that 6 items or more (out of 26) were missing at a certain visit, the UMSARS score for that visit was assigned a missing value."|Day 0 (baseline), Week 48|Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment were included in the principal efficacy analysis, according to the treatment group to which they were originally assigned.||units on a scale||Standard Error|Least Squares Mean
801895|NCT00977704|Primary|Local and Systemic Adverse Events|"To examine the safety of Restylane and Perlane when used in the treatment of facial wrinkles and folds by identification of the point incidence of:
All local adverse events as reported by healthcare professional
All systemic adverse events (related and unrelated)"|2-weeks|Primary object is to examine safety using descriptive statistics (frequency and percentage). Analysis was on the Intent to treat Population of all treated subjects, including those subjects for whom only incomplete data were available. No considerations (e.g. imputation) were made for missing data.||percentage of participants|||Number
801896|NCT00977769|Secondary|Bleeding|The calculated estimated blood loss from delivery until 2 h after intervention|120 minutes|||ml blood loss||Standard Deviation|Mean
801897|NCT00977769|Primary|Arterial Blood Pressure|The mean change in SAP compared with baseline at the time of delivery up to 2.5 minutes post delivery.|2.5 min|||percentage change in arterial blood pres||95% Confidence Interval|Mean
801898|NCT00977769|Primary|Cardiac Output|The relative change in CO from baseline at the time of delivery up to 2.5 minutes post delivery.|2.5 minutes|||percentage change in cardiac output||95% Confidence Interval|Mean
801899|NCT00977808|Primary|Occurrence of Hypoglycemic Episodes|Hypoglycemic events were defined as below 3.9 mmol/liter and the percentage of time within the range of 3.9 to 7.8 mmol/liter overnight (21:30 until 08:00) as measured by reference blood glucose (YSI or Beckman Glucose Analyzer).|Overnight (21:30 until 08:00)|Only participants who completed both study periods were considered for this assessment.||Hypoglycemic Episodes|||Number
801900|NCT00977938|Secondary|GUSTO Severe or Moderate Bleeding - Randomized BMS ITT|Bleeding was assessed according to the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) criteria.|21 months (12-33 months post-index procedure)|Only patients who could be evaluated were included in this analysis (i.e., patients whose last contact date was ≥600 days after randomization or who had any adjudicated bleeding event at or before 630 days).||percentage of patients|||Number
804370|NCT00997555|Primary|Respiratory Associated Mortality|Bronchoscopy group deaths n=0. Control group deaths n=1.|until death or discharge from hospital, data reviewed every 6 months|||participants|||Number
801903|NCT00977938|Secondary|GUSTO Severe or Moderate Bleeding - Randomized BMS ITT|Bleeding was assessed according to the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) criteria.|18 months (12-30 months post-index procedure)|Only patients who could be evaluated were included in this analysis (i.e., patients whose last contact date was ≥510 days after randomization or who had any adjudicated bleeding event at or before 540 days).||percentage of patients|||Number
801904|NCT00977938|Secondary|Definite or Probable Stent Thrombosis (ST) - Randomized BMS ITT|ST was assessed according to the Academic Research Consortium (ARC) definitions.|18 months (12-30 months post-index procedure)|All randomized BMS ITT patients; Patients were analyzed according to the treatment to which they were randomized (regardless of post-randomization compliance with the randomized treatment); Patients not experiencing the endpoint were censored at 30 months or at last known follow-up, whichever was earlier.||percentage of patients (KM estimate)|||Number
801905|NCT00977938|Secondary|MACCE (Death, Myocardial Infarction or Stroke) - Randomized BMS ITT||18 months (12-30 months post-index procedure)|All randomized BMS ITT patients; Patients were analyzed according to the treatment to which they were randomized (regardless of post-randomization compliance with the randomized treatment); Patients not experiencing the endpoint were censored at 30 months or at last known follow-up, whichever was earlier.||percentage of patients (KM estimate)|||Number
801906|NCT00977938|Secondary|GUSTO Severe or Moderate Bleeding - Randomized DES ITT|Bleeding was assessed according to the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) criteria.|21 months (12-33 months post-index procedure)|Only patients who could be evaluated were included in this analysis (i.e., patients whose last contact date was ≥600 days after randomization or who had any adjudicated bleeding event at or before 630 days).||percentage of patients|||Number
801907|NCT00977938|Secondary|Definite or Probable Stent Thrombosis (ST) - Randomized DES ITT|ST was assessed according to the Academic Research Consortium (ARC) definitions.|21 months (12-33 months post-index procedure)|All randomized DES ITT patients; Patients were analyzed according to the treatment to which they were randomized (regardless of post-randomization compliance with the randomized treatment); Patients not experiencing the endpoint were censored at 33 months or at last known follow-up, whichever was earlier.||percentage of patients (KM estimate)|||Number
801908|NCT00977938|Secondary|MACCE (Death, Myocardial Infarction or Stroke) - Randomized DES ITT||21 months (12-33 months post-index procedure)|All randomized DES ITT patients; Patients were analyzed according to the treatment to which they were randomized (regardless of post-randomization compliance with the randomized treatment); Patients not experiencing the endpoint were censored at 33 months or at last known follow-up, whichever was earlier.||percentage of patients (KM estimate)|||Number
801909|NCT00977938|Secondary|Definite or Probable Stent Thrombosis (ST) - Propensity Matched DES vs. BMS|Secondary powered endpoint|33 months (0-33 months post-index procedure)|A subsample created by matching BMS- to DES-treated patients exactly on prevalence of STEMI and then matching on remaining baseline characteristics via propensity score, using a caliper width of 0.10. A BMS-treated patient was matched to a variable number of DES-treated patients without replacement, up to a maximum of 8.||percentage of patients|||Number
801910|NCT00977938|Secondary|MACCE (Death, Myocardial Infarction or Stroke) - Propensity Matched DES vs. BMS|Secondary powered endpoint|33 months (0-33 months post-index procedure)|A subsample created by matching BMS- to DES-treated patients exactly on prevalence of STEMI and then matching on remaining baseline characteristics via propensity score, using a caliper width of 0.10. A BMS-treated patient was matched to a variable number of DES-treated patients without replacement, up to a maximum of 8.||percentage of patients|||Number
801911|NCT00977938|Primary|GUSTO Severe or Moderate Bleeding - Randomized DES ITT|The primary safety endpoint was moderate or severe bleeding within randomized DES ITT patients between 12 and 30 months post procedure. Bleeding was assessed according to the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) criteria.|18 months (12-30 months post-index procedure)|Only patients who could be evaluated were included in this analysis (i.e., patients whose last contact date was ≥510 days after randomization or who had any adjudicated bleeding event at or before 540 days).||percentage of patients|||Number
801912|NCT00977938|Primary|Definite or Probable Stent Thrombosis (ST) - Randomized DES ITT|The coprimary efficacy endpoints were the cumulative incidence of MACCE and the cumulative incidence of definite or probable ST within randomized DES ITT patients between 12 and 30 months post procedure. ST was assessed according to the Academic Research Consortium (ARC) definitions.|18 months (12-30 months post-index procedure)|All randomized DES ITT patients; Patients were analyzed according to the treatment to which they were randomized (regardless of post-randomization compliance with the randomized treatment); Patients not experiencing the endpoint were censored at 30 months or at last known follow-up, whichever was earlier.||percentage of patients (KM estimate)|||Number
801913|NCT00977938|Primary|MACCE (Death, Myocardial Infarction or Stroke) - Randomized DES ITT|The coprimary efficacy endpoints were the cumulative incidence of MACCE and the cumulative incidence of ARC definite or probable stent thrombosis within randomized DES ITT patients between 12 and 30 months post procedure.|18 months (12-30 months post-index procedure)|All randomized DES ITT patients; Patients were analyzed according to the treatment to which they were randomized (regardless of post-randomization compliance with the randomized treatment); Patients not experiencing the endpoint were censored at 30 months or at last known follow-up, whichever was earlier.||percentage of patients (KM estimate)|||Number
801914|NCT00978029|Secondary|Proportion of Participants Who Discontinued Due to Adverse Events.|Participants were treated for 28 days with either 6 or 12 Units of SCH 39641 or placebo, and the proportion with AEs leading to study discontinuation were reported. An AE is any unfavorable and unintended sign, symptom or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Up to Day 28|ASAT consisting of all randomized participants who received at least one dose of study treatment. Due to non-compliance with GCP 7 participants were excluded from this analysis.||Proportion of Participants|||Number
801915|NCT00978029|Secondary|Proportion of Participants Reporting Mouth Oedema|Participants were treated for 28 days with either 6 or 12 Units of SCH 39641 or placebo, and the proportion with mouth oedema were reported.|Up to Day 42|ASAT consisting of all randomized participants who received at least one dose of study treatment. Due to non-compliance with GCP 7 participants were excluded from this analysis.||Proportion of Participants|||Number
801916|NCT00978029|Secondary|Proportion of Participants Reporting Throat Irritation|Participants were treated for 28 days with either 6 or 12 Units of SCH 39641 or placebo, and the proportion with throat irritation were reported.|Up to Day 42|ASAT consisting of all randomized participants who received at least one dose of study treatment. Due to non-compliance with GCP 7 participants were excluded from this analysis.||Proportion of Participants|||Number
801917|NCT00978029|Secondary|Proportion of Participants Reporting Ear Pruritus|Participants were treated for 28 days with either 6 or 12 Units of SCH 39641 or placebo, and the proportion with ear pruritus were reported.|Up to Day 42|ASAT consisting of all randomized participants who received at least one dose of study treatment. Due to non-compliance with GCP 7 participants were excluded from this analysis.||Proportion of Participants|||Number
801918|NCT00978029|Secondary|Proportion of Participants Reporting Oral Pruritus|Participants were treated for 28 days with either 6 or 12 Units of SCH 39641 or placebo, and the proportion with oral pruritus were reported.|Up to Day 42|ASAT consisting of all randomized participants who received at least one dose of study treatment. Due to non-compliance with GCP 7 participants were excluded from this analysis.||Proportion of Participants|||Number
801919|NCT00978029|Primary|The Proportion of Participants Reporting Treatment-emergent Adverse Events (AEs)|Participants were treated for 28 days with either 6 or 12 Units of SCH 39641 or placebo, and the proportion with treatment-emergent AEs were recorded. An AE is any unfavorable and unintended sign, symptom or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment-emergent AEs are new AEs that occur after participants have been randomized into the trial, or existing AEs that occurred during Screening that increase in severity after randomization.|Up to Day 42|All subjects as treated (ASAT) consisting of all randomized participants who received at least one dose of study treatment. Due to non-compliance with GCP 7 participants were excluded from this analysis.||Proportion of Participants|||Number
801920|NCT00978042|Secondary|Responder Rate Based on Improvement in Score on MFVDS by Facial Region|The investigator evaluated the volume deficit of the patient's face using the MFVDS 6-point scale where: 0=none (best) to 5=severe (worst). To be considered a “responder,” the average of the blinded, independent Evaluating Investigators’ assessments of the participant’s respective mid-facial area score on MFVDS at 6 months had to be improved (reduced) by ≥ 1 grade compared with the average of the Evaluating Investigator pre-treatment assessments. The percentage of responders is categorized by facial region.|6 months|Only those participants from the Modified-intent-to-treat (MITT) population randomized to the Treatment Arm who received treatment with available data are included in the analysis.||percentage of responders|||Number
801921|NCT00978042|Secondary|Responder Rate Based on Improvement in Score on Global Aesthetic Improvement Scale (GAIS)|The investigator evaluated the patient's overall mid-face volume using the GAIS 5-point scale where: 2=much improved to -2=much worse. To be considered a “responder,” the average of the blinded, independent Evaluating Investigators’ assessments of the participant’s overall score on GAIS at 6 months had to be improved (reduced) by ≥ 1 grade compared with the average of the Evaluating Investigator pre-treatment assessments.|6 months|Only those participants from the Modified-intent-to-treat (MITT) population randomized to the Treatment Arm who received treatment with available data are included in the analysis.||Percentage of responders|||Number
801922|NCT00978042|Secondary|Duration of Treatment Effect|Duration of treatment effect was determined by Kaplan-Meier (KM) product limit estimate of the percentage of participants in the treatment group that maintained at least a 1-point improvement in the overall mid-face volume deficit score on the Mid-Face Volume Deficit Scale (MFVDS) based on the average of the 2 blinded Evaluating Investigators’ assessments (with 95% Greenwood's Confidence Interval).|24 Months|"Participants from the Modified-intent-to-treat (MITT) population, all participants randomized to the treatment arm who received treatment and all participants randomized to no treatment control arm who received treatment, with data available for analysis."||Percentage of participants||95% Confidence Interval|Number
801923|NCT00978042|Primary|Responder Rate Based on Improvement in Score on Validated 6-point Mid-Face Volume Deficit Scale (MFVDS)|The primary effectiveness variable was responder rate for the treatment group. The investigator evaluated the volume deficit of the patient's face using the MFVDS 6-point scale where: 0=none (best) to 5=severe (worst). To be considered a “responder,” the average of the blinded, independent Evaluating Investigators’ assessments of the participant’s overall score on MFVDS at 6 months had to be improved (reduced) by ≥ 1 grade compared with the average of the Evaluating Investigator pre-treatment assessments.|6 months|"Participants from the Modified-intent-to-treat (MITT) population, all participants randomized to treatment who received treatment and all participants randomized to no treatment control arm, with data available for analysis."||percentage of responders||95% Confidence Interval|Number
801924|NCT00978120|Primary|Percentage of Participants With Seroprotection at Day 41 Following Two Administrations of Vaccination, Severe Asthmatics|Percentage of participants with seroprotection defined as a hemagglutination inhibition assay (HAI) antibody titer of 1:40 or greater against influenza H1N1 2009 virus following two administrations of the H1N1 vaccine at each dose, combined across age groups.|Days 1 to 41|||percentage of participants|||Number
801925|NCT00978120|Primary|Percentage of Participants With Seroprotection at Day 41 Following Two Administrations of Vaccination, Mild-Moderate Asthmatics|Percentage of participants with seroprotection defined as a hemagglutination inhibition assay (HAI) antibody titer of 1:40 or greater against influenza H1N1 2009 virus following two administrations of the H1N1 vaccine at each dose, combined across age groups.|Days 1 to 41|||percentage of participants|||Number
801926|NCT00978120|Primary|Percentage of Participants With Seroprotection at Day 28 Following Two Administrations of Vaccination, Severe Asthmatics|Percentage of participants with seroprotection defined as a hemagglutination inhibition assay (HAI) antibody titer of 1:40 or greater against influenza H1N1 2009 virus following two administrations of the H1N1 vaccine at each dose, combined across age groups.|Days 1 to 28|||percentage of participants|||Number
801927|NCT00978120|Primary|Percentage of Participants With Seroprotection at Day 28 Following Two Administrations of Vaccination, Mild-Moderate Asthmatics|Seroprotection: The percentage of participants with a hemagglutination inhibition assay (HAI) antibody titer of 1:40 or greater against influenza H1N1 2009 virus following two administrations of the H1N1 vaccine at each dose, combined across age groups.|Days 1 to 28|||percentage of participants|||Number
804371|NCT00997555|Primary|All Cause Mortality|Bronchoscopy group deaths n=0. Control group deaths n=1.|until death or discharge from hospital, data reviewed every 6 months|||participants|||Number
801928|NCT00978120|Primary|Percentage of Participants With Seroconversion at Day 41 Following Two Administrations of Vaccination, Severe Asthmatics|Seroconversion: The percentage of participants with a four-fold or greater hemagglutination inhibition assay (HAI) antibody titer increase compared to baseline against the novel influenza hemagglutinin type 1 and neuraminidase type 1 (H1N1) 2009 virus following two administrations of Novartis H1N1 vaccine at each dose, combined across age groups.|Days 1 to 41|||percentage of participants|||Number
801929|NCT00978120|Primary|Percentage of Participants With Seroconversion at Day 41 Following Two Administrations of Vaccination, Mild-Moderate Asthmatics|Seroconversion: The percentage of participants with a four-fold or greater hemagglutination inhibition assay (HAI) antibody titer increase compared to baseline against the novel influenza hemagglutinin type 1 and neuraminidase type 1 (H1N1) 2009 virus following two administrations of Novartis H1N1 vaccine at each dose, combined across age groups.|Days 1 to 41|||percentage of participants|||Number
801930|NCT00978120|Primary|Percentage of Participants With Seroconversion at Day 28 Following Two Administrations of Vaccination, Severe Asthmatics|Seroconversion: The percentage of participants with a four-fold or greater hemagglutination inhibition assay (HAI) antibody titer increase compared to baseline against the novel influenza hemagglutinin type 1 and neuraminidase type 1 (H1N1) 2009 virus following two administrations of Novartis H1N1 vaccine at each dose, combined across age groups.|Days 1 to 28|||percentage of participants|||Number
801931|NCT00978120|Primary|Percentage of Participants With Seroconversion at Day 28 Following Two Administrations of Vaccination, Mild-Moderate Asthmatics|Seroconversion: The percentage of participants with a four-fold or greater hemagglutination inhibition assay (HAI) antibody titer increase compared to baseline against the novel influenza hemagglutinin type 1 and neuraminidase type 1 (H1N1) 2009 virus following two administrations of Novartis H1N1 vaccine at each dose, combined across age groups.|Days 1 to 28|||percentage of participants|||Number
801932|NCT00978120|Secondary|Percentage of Participants With Seroprotection at Day 21 Following Single Administration of Vaccination, Severe Asthmatics|Percentage of participants with seroprotection defined as hemagglutination inhibition assay (HAI) antibody titer of 1:40 or greater against influenza H1N1 2009 virus following a single administration of the H1N1 vaccine at each dose, combined across age groups.|Days 1 to 21|||percentage of participants|||Number
801933|NCT00978120|Secondary|Percentage of Participants With Seroprotection at Day 21 Following Single Administration of Vaccination, Mild-Moderate Asthmatics|Percentage of participants with seroprotection defined as hemagglutination inhibition assay (HAI) antibody titer of 1:40 or greater against influenza H1N1 2009 virus following a single administration of the H1N1 vaccine at each dose, combined across age groups.|Days 1 to 21|||percentage of participants|||Number
801934|NCT00978120|Secondary|Percentage of Participants With Seroconversion at Day 21 Following Single Administration of Vaccination, Severe Asthmatics|Percentage of participants with seroconversion defined as a four-fold or greater hemagglutination inhibition assay(HAI) antibody titer increase compared to baseline against the novel influenza hemagglutinin type 1 and neuraminidase type 1 (H1N1) 2009 virus following a single administration of Novartis H1N1 vaccine at each dose, combined across age groups.|Days 1 to 21|||percentage of participants|||Number
801935|NCT00978120|Secondary|Percentage of Participants With Seroconversion at Day 21 Following Single Administration of Vaccination, Mild-Moderate Asthmatics|Percentage of participants with seroconversion defined as a four-fold or greater hemagglutination inhibition assay (HAI) antibody titer increase compared to baseline against the novel influenza hemagglutinin type 1 and neuraminidase type 1 (H1N1) 2009 virus following a single administration of Novartis H1N1 vaccine at each dose, combined across age groups.|Days 1 to 21|||percentage of participants|||Number
801936|NCT00978120|Primary|Percentage of Participants With Asthma Exacerbations Status Post Vaccination 2|Percentage of participants with asthma exacerbations within 8 days after vaccination 2. Any of the following events are considered asthma exacerbation: Increase in the daily use of bronchodilator rescue medication for 2 consecutive days; an increase is defined as ≥6puffs of bronchodilator from a metered-dose inhaler or ≥2 uses of nebulized albuterol above average use reported in the two weeks prior to Visit 1. Increase in use of systemic corticosteroids or the addition of systemic corticosteroids to treatment regimen for asthma. Unscheduled use of health care for the treatment of asthma.|Days 21 to 28|||percentage of participants|||Number
801937|NCT00978120|Primary|Percentage of Participants With Asthma Exacerbations Status Post Vaccine 1|Percentage of participants with asthma exacerbations within 8 days after vaccination 1. Any of the following events are considered asthma exacerbation: Increase in the daily use of bronchodilator rescue medication for 2 consecutive days; an increase is defined as ≥6puffs of bronchodilator from a metered-dose inhaler or ≥2 uses of nebulized albuterol above average use reported in the two weeks prior to Visit 1. Increase in use of systemic corticosteroids or the addition of systemic corticosteroids to treatment regimen for asthma. Unscheduled use of health care for the treatment of asthma.|Days 1 to 8|||percentage of participants|||Number
801938|NCT00978120|Primary|Percentage of Participants With Reactogenicity Adverse Events (AEs) Status Post Vaccine 2|Percentage of participants with reactogenicity AEs, local (erythema, ecchymosis, induration, pain and tenderness at the injection sites) and systemic (feverishness, chills, fatigue, myalgias, arthralgias, headache and nausea), within 8 Days After Vaccination 2 by Dose Level Group.|Days 21 through 28|||percentage of participants|||Number
801939|NCT00978120|Primary|Percentage of Participants With Reactogenicity Adverse Events (AEs) Status Post Vaccine 1|Percentage of participants with reactogenicity AEs, local (erythema, ecchymosis, induration, pain and tenderness at the injection sites) and systemic (feverishness, chills, fatigue, myalgias, arthralgias, headache and nausea), within 8 Days After Vaccination 1 by Dose Level Group.|Days 1 through 8|||percentage of participants|||Number
801940|NCT00978120|Primary|Percentage of Participants With Serious Adverse Events (SAEs) Attributed To Vaccination|Percentage of participants with serious adverse events (SAEs) attributed to vaccination, as determined by site investigators at the time of reporting.|Measured at Baseline Visit and Days 1, 8, 21, 28, 41, 80, 120, and 201|||percentage of participants|||Number
801941|NCT00978341|Secondary|Pharmacokinetic Evaluations of Pregabalin|Pharmacokinetic (PK) results are not presented in this report due to early termination of the trial. Pregabalin PK was not measured as there was incomplete data to conduct pharmacokinetic/pharmacodynamic analyses.|Day 1: 0 (pre-dose), 0.5, 1, 2, and 6 hours post-dose; Day 8: 0 (pre-dose), 1, 4, & 6 hours post-dose||||||
812455|NCT01070784|Primary|Clinical Laboratory Test: Clinical Chemistry- S-C-Reactive Protein|Change from baseline|Baseline and 52 week after|||mg/dL||Standard Deviation|Mean
801942|NCT00978341|Secondary|Neuropathic Pain Symptom Inventory (NPSI)|NPSI: subject rated questionnaire to evaluate 5 dimensions of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia). Includes 10 descriptors ranging from 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each relevant dimension. Total score is calculated as the sum of scores of the 10 descriptors, range: 0-100. Higher score indicates greater intensity of pain.|Prior to morning dosing on Day 1 and prior to discharge on Day 8 for each period.|FAS; Combined results for At-level and Below-level of spinal cord injury.||scores on scale||Inter-Quartile Range|Median
801943|NCT00978341|Secondary|Mechanical Pain Sensitivity Stimulus-Response Function|Mechanical pain sensitivity stimulus response function was assessed at the control and painful sites using calibrated von Frey monofilaments and the SENSElab brush. Seven different von Frey monofilaments (8 –512 milliNewtons [mN], force increases by a factor of two from filament to filament) and the brush were applied in a predetermined pseudo-random order. Pain rating for each stimulus: 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst possible pain).|Screening, Days 1 & 8: 0 (pre-dose), & 2, 4, and 6 hours post-dose|FAS; combined results for At-level and Below-level of spinal cord injury.||scores on scale||Standard Deviation|Mean
801944|NCT00978341|Secondary|Punctate Allodynia Area|Area of punctate allodynia was determined using a von Frey filament (OptiHair2). Stimulation was started from the non-painful perimetry and repeated along a pattern of 8 radial spokes. With a movement along each spoke at steps of 5 millimeters (mm), the subjects reported sensation changes from non-painful to painful and the spot was marked on the skin. The area of punctate allodynia was determined from these 8 distances by calculating the area of an octagon (in square centimeter(s)[cm2]).|Screening, Days 1 & 8: 0 (pre-dose) and 4 hours post-dose|FAS; combined results for At-level and Below-level spinal cord injury.||cm2||Standard Deviation|Mean
801945|NCT00978341|Secondary|Dynamic Allodynia Pain Score|Five strokes (each approx. 6 centimeters [cm] long) were applied with a standardized brush (SENSELab Brush 05) across the painful site (and a control site) at a constant velocity (20 millimeters per second [mm/sec]). Pain in response to brush stimulation of the allodynic area was recorded using an 11-point numeric rating scale from 0 (no pain) to 10 (worst possible pain). Patients were asked to give a pain rating after each brush stroke. A painful sensation was considered as representing brush allodynia.|Screening, Days 1 & 8: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, and 6 hours post-dose|FAS; Combined results for At-level and Below-level of spinal cord injury.||scores on scale||Standard Deviation|Mean
801946|NCT00978341|Secondary|Dynamic Allodynia Area|Area of dynamic allodynia was assessed using a brush (SENSElab Brush 05; velocity approximately 20 millimeters per second [mm/s]) by stimulating along a pattern of 8 radial spokes. Stimulation was started from the non-painful perimetry. Subjects were asked to report change in sensation from non-painful to painful and the spot was marked onto the skin. The area of dynamic allodynia was determined from these 8 distances by calculating the area of an octagon (in centimeter squared [cm2]).|Screening, Days 1 & 8: 0 (pre-dose) & 4 hours post-dose,|FAS; Combined results for At-level and Below-level of spinal cord injury.||cm2||Standard Deviation|Mean
801947|NCT00978341|Secondary|Daily Pain Score|Daily Pain Score: Day 1 pain intensity over past 24 hours recorded on waking every morning. 0-10 numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain).|Predose: Daily from 7 days before Visit 2 (start of Intervention 1) until the morning of Visit 5 (end of Intervention 2)|FAS; Combined results for At-level and Below-level of spinal cord injury.||scores on scale||Standard Deviation|Mean
801948|NCT00978341|Primary|Present Pain Intensity Score|Present pain intensity score: 0-10 numeric rating scale (NRS), 0 (no pain) to 10 (worst possible pain).|Day 1: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours (post-dose); Day 8: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours (post-dose)|Full analysis set (FAS): those subjects who completed both periods of the study. Combined results for At-level and Below-level neuropathic pain; At-level: located within 2 dermatomes above or below the level of spinal cord injury; Below-level: located at least 3 dermatomes below the level of spinal cord injury.||scores on scale||Standard Deviation|Mean
801949|NCT00978380|Secondary|Antibody and Inhibitor Development|All subjects who received rFXIII were monitored for anti-rFXIII antibodies and inhibitor development. Samples passed through 2 tiers of ELISA testing: an initial screen with a specific cut-off point (including ~5% false positives) and a second confirmatory assay for samples yielding a result above the screening cut-off point. If samples were confirmed as antibody positive in the confirmation assay, an inhibitor assay was also carried out to detect functional inhibitors. Percentage of subjects with antibody and inhibitor development were reported.|From week 0 to week 52|The safety analysis set included all subjects exposed to trial product in this extension trial.||Percentage of subjects|||Number
801950|NCT00978380|Primary|Adverse Events (AEs)(Serious and Non-serious)|An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Trial AEs (serious) included any event such as death, life-threatening experience, in-subject hospitalisation, significant disability/ congential anomaly experienced from the trial product.|All AEs were collected and reported from screening (week 0) for a minimum period of 52 weeks or until the end of trial visit.|The FAS included the 60 unique subjects exposed to trial product in this extension trial.||Events|||Number
801951|NCT00978432|Secondary|Evaluate the Association of Observed Response to the Doublet With the Response Predicted by Molecular Signatures for Activated B Cell Like (ABC) DLBCL and for Germinal Center B Cell Like (GCB) DLBCL.|"Response rates seen in subjects with activated B cell like DLBCL and for Germinal center B cell like DLBCL will be reported and assessed to see if GCB is associated with improved outcomes compared to ABC in subjects with relapsed disease who have received RAD + LBH. We will estimate the association of the ABC and GCB with the observed response. All evaluable patients will be used in estimating response. The chi-square test with one-sided alpha of 0.10 will be used to test for the association between predicted and observed responses.
The number of responses to treatment were so few that we did not think we could get enough meaningful data for analysis."|up to 13 cycles of therapy; approximately 1 year|The number of responses to treatment were so few that we did not think we could get enough meaningful data for analysis. Therefore, molecular analysis was not performed and no results are available.|||||
812456|NCT01070784|Primary|Clinical Laboratory Test: Clinical Chemistry- S-Protein, Total|Change from baseline|Baseline and 52 week after|||g/dL||Standard Deviation|Mean
801952|NCT00978432|Secondary|Distribution of Change Across Time of mTOR and HDAC-I Inhibition From Baseline Until After the 1st 2 Cycles of Study Drug in Patients Who Received LBH and RAD.|Serum markers will be measured on the first day of cycle 1 and on the first day of cycle 3. The distribution of change across time in a marker will be summarized.|after 2 cycles of study therapy; up to 8 weeks|The number of responses to treatment were so few that we did not think we could get enough meaningful data for analysis. Therefore, serum marker analysis was not performed and no results are available.|||||
801953|NCT00978432|Secondary|Summary of Adverse Events (AEs)|Counts of adverse events or treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose) experienced by patients on study drug(s). National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) is used to assess severity. Relatedness to study drug is assessed by the investigator.|From the time of first dose of study drug until 4 weeks after participant has stopped study drug; up to 1 year|Participants who consented to the study and took study drug were analyzed for this outcome measure. Total number of events per CTCAE v4 category per arm are reported if more than one event occurred.||events|||Number
801954|NCT00978432|Primary|Assessment of Association Between Observed Response to RAD001 and LBH589 and the Response Predicted by Molecular Signatures Developed in Our Pre-clinical Model|We will estimate the association of the molecular signature-predicted response to the doublet (CR+PR) with the observed response. All evaluable patients will be used in estimating response. The chi-square test with one-sided alpha of 0.10 will be used to test for the association between predicted and observed responses. Contingency tables will be used to present these associations.|From the start of combination therapy until a maximum of 2 years after completion of therapy|The number of responses to treatment were so few that we did not think we could get enough meaningful data for analysis. Therefore, molecular analysis was not performed and no results are available.|||||
801955|NCT00978432|Primary|Overall Response Rate|Overall Response Rate is the number of participants with a partial and complete response assessed by the Updated Cheson criteria for lymphoma. A complete response is complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy and normalization of those biochemical abnormalities. If a subject has residual lesions on CT scan and the disease was fluorodeoxyglucose (FDG) avid pre-treatment, then that subject will be considered to be in a complete response. Partial response is a greater than or equal to 50% decrease in the sum of the products of the greatest diameters of 6 largest dominant nodes or nodal masses. No increase in size of nodes, liver or spleen and no new sites of disease|after 2 cycles of each study drug or after 2 cycles of doublet, up to 24 weeks|Patients have to be on each drug for at least 2 cycles to be evaluable for response.||participants|||Number
801956|NCT00978445|Secondary|Change in Quality of Life - Based on Quality of Life Scores PSQ-18 (Short Form Patient Satisfaction Questionnaire) Duke Anticoagulation Satisfaction Scale SF-12 (Short Form 12 Version 2) Quality of Life Questionnaire|"we are interested in the relative measure of quality of life by comparing quality of life measures through use of PSQ-18 and other measures listed.
Higher scores indicate a better quality of life."|During study vist number 2 after 12 week study period, repeated after second study 12 week period study visit #3|power analysis||scores on a scale||Standard Deviation|Mean
801957|NCT00978445|Primary|Time Spent Per PT/INR Monitoring Encounter|minutes spent measuring coagulation time of blood on standard versus home protocol|Once per week during 12 week study|through minimum power study||minutes||Standard Deviation|Mean
801958|NCT00978562|Secondary|Volume of Enhancing Lesions|Appropriate descriptive statistics will be estimated. Results will be posted at overall completion.|Up to 2 years||12/2018||||
801959|NCT00978562|Secondary|Ultrastructure (Only in Patients for Whom a Biopsy or Surgery is Scheduled Outside of This Protocol)|Appropriate descriptive statistics will be estimated. Results will be posted at overall completion.|Up to 2 years||12/2018||||
801960|NCT00978562|Secondary|Tumor Vascularity|Appropriate descriptive statistics will be estimated. Results will be posted at overall completion.|Up to 2 years||12/2018||||
801961|NCT00978562|Secondary|Number of Enhancing Lesions|Appropriate descriptive statistics will be estimated. Results will be posted at overall completion.|Up to 2 years||12/2018||||
801962|NCT00978562|Secondary|Histology (Only in Patients for Whom a Biopsy or Surgery is Scheduled Outside of This Protocol)|Appropriate descriptive statistics will be estimated. Results will be posted at overall completion.|Up to 2 years||12/2018||||
801963|NCT00978562|Primary|Vascular Properties of Pediatric Brain Tumors Using Dynamic Contrast-enhanced MRI (DCE-MRI) After Administration of a Gadolinium-based Contrast Agent|Volume transfer coefficient reflecting vascular permeability of pediatric brain tumors using Dynamic Contrast-enhanced MRI (DCE-MRI) was measured. Subjects undergo MRI with ferumoxytol (study drug) and gadolinium (standard contrast agent) in the same imaging session. Ferumoxytol is given first and DSC images obtained, followed by gadolinium, and DCE images are obtained.|up to 2 years|||min^-1||Standard Deviation|Mean
801964|NCT00978562|Primary|Vascular Properties of Pediatric Brain Tumors Using Dynamic Susceptibility-weighted Contrast Enhanced MRI (DSC-MRI) After Administration of Ferumoxytol|Signal intensity, relative cerebral blood volume (rCBV) was measured. Relative CBV measurements were calculated from regions of interest (ROI) that were placed in regions of highest perfusion seen on the rCBV color overlay parametric maps.The mean of 3 regions of contralateral white matter was used as the internal reference standard. The size of the ROIs was kept constant (radius 1.5 mm). Parametric color overlay maps were analyzed using ImageJ software (NIH, Bethesda, MD, USA).|Up to 2 years|||mL/g||Standard Deviation|Mean
801965|NCT00978627|Primary|Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)|Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.|Week 0 to Week 53 + 7 days of follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||Events/100 years of patient exposure|||Number
805488|NCT01003184|Secondary|Change in HbA1c From Baseline to Week 26|Change in HbA1c from baseline to week 26|Baseline, Week 26|The analysis was done for the FAS population (as randomised).||Percentage of total hemoglobin||Standard Error|Least Squares Mean
801966|NCT00978627|Secondary|Extension Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment|Change from baseline in FPG after 52 weeks of treatment.|Week 0, Week 53|The full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). For 2 subjects, FPG values were missing.||mmol/L||Standard Deviation|Mean
801967|NCT00978627|Secondary|Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 a.m.|Week 0 to Week 26 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||Episodes/100 years of patient exposure|||Number
801968|NCT00978627|Primary|Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 a.m.|Week 0 to Week 53 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||Episodes/100 years of patient exposure|||Number
801969|NCT00978627|Primary|Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol /L.|Week 0 to Week 53 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||Episodes/100 years of patient exposure|||Number
801970|NCT00978627|Secondary|Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment|Change from baseline in HbA1c after 52 weeks of treatment|Week 0, Week 53|The full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF).||percentage of glycosylated haemoglobin||Standard Deviation|Mean
801971|NCT00978627|Secondary|Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26|Overall mean of 9-point SMPG at 26 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast.|Week 26|The full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). For 22 subjects all 9-point SMPG values were missing.||mmol/L||Standard Deviation|Mean
801972|NCT00978627|Secondary|Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 26 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||Episodes/100 years of patient exposure|||Number
801973|NCT00978627|Primary|Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment|Change from baseline in HbA1c after 26 weeks of treatment|Week 0, Week 26|The full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF).||percentage of glycosylated haemoglobin||Standard Deviation|Mean
801974|NCT00978731|Secondary|Median Number of Months of Overall Survival (OS) (Kaplan Meier Method)|Overall survival was defined as the median number of months from baseline to death from any cause.|Baseline to study discontinuation. Median duration of exposure (on-study time) was 23.4 months.|All treated participants.||months||95% Confidence Interval|Median
801975|NCT00978731|Secondary|Median Number of Months of Progression-free Survival (PFS) (Kaplan Meier Method)|Interval between randomization date & earliest date of disease progression/death due to any cause, assessed by the Independent Radiology Review Committee (IRRC) using modified World Health Organization (WHO) criteria to define progressive disease (PD): >=25% increase in sum of products of diameters (SOPD) of lesions compared with smallest SOPD recorded for study period or progression of any non-index lesion/appearance of new lesion. If no progression/death, date of last tumor assessment used. For participants who had no on-study tumor assessments & were still alive, date of randomization used.|Baseline to study discontinuation. Median duration of exposure (on-study time) was 23.4 months.|All treated participants.||months||95% Confidence Interval|Median
801976|NCT00978731|Secondary|Number of Participants With Best Cytogenetic Response|Cytogenetic responses are based on the prevalence of Ph+ metaphases among cells in metaphase on a bone marrow sample. CCyR: 0% Ph+ cells in metaphase in bone marrow, PCyR: >0% to 35% Ph+ cells in metaphase in bone marrow, Minor CyR: >35% to 65% Ph+ cells in metaphase in bone marrow, Minimal CyR: >65% to 95% Ph+ cells in metaphase in bone marrow and No CyR: >95% to 100% Ph+ cells in metaphase in bone marrow.|Pre-treatment to study discontinuation. Median duration of exposure (on-study time) was 23.4 months.|All treated participants with evaluable sample sizes. Data was not analyzed and reported for the Accelerated Phase CML and Myeloid Blast Phase CML groups due to small sample sizes, which would lead to response rate estimates that are not stable.||participants|||Number
801987|NCT00979017|Secondary|Median Overall Survival (OS)|Time in months from the start of study treatment to the date of death due to any cause. Patients alive as of the last follow-up had OS censored at the last follow-up date. Median OS was estimated using a Kaplan-Meier curve.|36 months|Intent-to-treat||months||95% Confidence Interval|Median
812457|NCT01070784|Primary|Clinical Laboratory Test: Clinical Chemistry- S-Albumin|Change from baseline|Baseline and 52 week after|||g/dL||Standard Deviation|Mean
801977|NCT00978731|Primary|Number of Participants With Dose Interruptions and Dose Reductions|Dose interruptions and reductions were allowed, in order to optimize individual participant’s hematologic, cytogenetic, and molecular response while maintaining and evaluating safety and tolerability of long-term exposure to dasatinib. A dose reduction is defined as the administration of a dose at a lower level compared to previous dose and such that reduced dose, or a lower dose, is given at least 4 consecutive times. In determining the reductions, dose level would be compared to the previous non-null dose. Dose interruption is defined as a complete omission of dosing for 4 consecutive times.|From start of study to final assessment (up to 32.2 months).|All treated participants.||participants|||Number
801978|NCT00978731|Secondary|Median Number of Months of Major Cytogenetic Response (MCyR)|MCyR: 0% Ph+ cells in metaphase in bone marrow or Partial Cytogenetic Response (PCyR): >0% to 35% Ph+ cells in metaphase in bone marrow.The duration of MCyR was computed for chronic phase participants whose best response is either CCyR or PCyR. It was measured in months from the time measurement criteria are first met for CCyR or PCyR (whichever status is recorded first) until the date of progression or death. Participants who neither progress nor die are censored on the date of their last cytogenetic assessment.|Pre-treatment to study discontinuation. Median duration of exposure (on-study time) was 23.4 months.|All treated participants with CML (whether QD or BID dosing), who had MCyR (13 participants had MCyR in QD group and 9 in BID group). Data were not analyzed and reported for the other two groups (Accelerated Phase CML and Myeloid Blast Phase CML) due to small sample sizes.||months||95% Confidence Interval|Median
801979|NCT00978731|Primary|Number of Participants With Grade 3-4 Serum Chemistry Abnormalities|Abnormalities were graded per the NCI (CTC), v3.0 (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening). Grade 3 and 4 criteria are as follows: Alanine aminotransferase (ALT): Grade 3: 5.0-20.0 * ULN (upper limit of normal), Grade 4: >20.0 * ULN; Calcium: Grade 3: 6.0-<7.0 or >12.5-13.5 mg/dL, Grade 4: <0.6->13.5 mg/dL; Bilirubin: Grade 3: >3-10 * ULN, Grade 4: >10 * ULN; Creatinine: Grade 3: >3.0-6.0 * ULN, Grade 4: >6.0 * ULN; Albumin: Grade 3: <2g/dL (Grade 4 not defined in NCI CTC); Magnesium: Grade 3: 0.6-<0.8 or >2.46-6.6mEq/L, Grade 4: <0.6 or >6.6mEq/L.|From start of study until up to 30 days after end of study participation. Median duration of exposure (on-study time) was 23.4 months.|All treated participants.||participants|||Number
801980|NCT00978731|Secondary|Number of Participants With Major Cytogenetic Response (MCyR)|Cytogenetic responses are based on the prevalence of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase on a bone marrow sample. MCyR is defined as number of participants with Complete Cytogenetic Response (CCyR): 0% Ph+ cells in metaphase in bone marrow or Partial Cytogenetic Response (PCyR): >0% to 35% Ph+ cells in metaphase in bone marrow.|Pre-treatment to study discontinuation. Median duration of exposure (on-study time) was 23.4 months.|All treated participants with evaluable sample sizes. Data was not analyzed and reported for the Accelerated Phase CML and Myeloid Blast Phase CML groups due to small sample sizes, which would lead to response rate estimates that are not stable.||participants|||Number
801981|NCT00978731|Secondary|Median Number of Months of CHR (Kaplan Meier Method)|CHR: WBC<=ULN (range: 9.29-12.5*10^3 c\uL); ANC >=1000/mm^3;Platelets <450000/mm^3,no blasts/promyelocytes in peripheral blood; <5% myelocytes+metamyelocytes in peripheral blood; basophils in peripheral blood <20% & no extramedullary involvement. Duration computed for chronic phase participants, measured in months from first day CHR criteria met, provided they are confirmed 4 weeks later, until progression of disease, treatment discontinuation due to progressive disease or death. Participants who neither discontinue due to progression, nor progress nor die censored on date of last assessment.|Pre-treatment to study discontinuation. Median duration of exposure (on-study time) was 23.4 months.|All treated participants with CML (whether QD or BID dosing), who had CHR. Data were not analyzed and reported for the other two groups (Accelerated Phase CML and Myeloid Blast Phase CML) due to small sample sizes.||months||95% Confidence Interval|Median
801982|NCT00978731|Secondary|Number of Participants With Complete Hematologic Response (CHR)|CHR should meet all of the following criteria: WBC <= Institutional ULN; ANC >= 1000/mm^3 ; Platelets < 450 000/mm^3 , no blasts or promyelocytes in peripheral blood; < 5% myelocytes plus metamyelocytes in peripheral blood; basophils in peripheral blood < 20% and no extramedullary involvement (including no hepatomegaly or splenomegaly). CHR can begin only 14 days after the start of treatment.|Pre-treatment to study discontinuation. Median duration of exposure (on-study time) was 23.4 months.|All treated participants. Data was not analyzed and reported for the other two groups (Accelerated Phase CML and Myeloid Blast Phase CML) due to small sample sizes.||participants|||Number
801983|NCT00978731|Primary|Number of Participants With Grade 3-4 Hematology Abnormalities|Abnormalities were graded per the National Cancer Institute(NCI)Common Toxicity Criteria (CTC), v3.0(Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening). Grade 3 and 4 criteria are as follows: Hemoglobin: Grade 3:6.5 - <8.0g/dL, Grade 4: <6.5g/dL. Platelets: Grade 3: 25.0 - <50.0*10^9/L, Grade 4: <25.0*10. Absolute Neutrophil Count (ANC): Grade 3: 0.5 - <1.0*10^9/L, Grade 4: <0.5*10^9/L.White Blood Cells (WBC) : Grade 3: 1.0 - <2.0*10^9/L, Grade 4: <1.0*10^9/L.|From start of study until up to 30 days after end of study participation. Median duration of exposure (on-study time) was 23.4 months.|All treated participants.||participants|||Number
801984|NCT00978731|Primary|Number of Participants Who Experienced Drug-related AEs and Drug-related SAEs.|Drug-related AEs are those events with a relationship to the study therapy of certain; probable; or possible or missing. Drug-related SAEs are those events with any relationship to the study therapy.|From start of study until up to 30 days after end of study participation. Median duration of exposure (on-study time) was 23.4 months.|All treated participants.||participants|||Number
801985|NCT00978731|Primary|Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation.|AEs: any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to AEs were recorded. These data differ from that in the Participant Flow section. This is because the data were collected on 2 different pages of the Case Report Form and were not reconciled.|From start of study until up to 30 days after end of study participation. Median duration of exposure (on-study time) was 23.4 months.|All treated participants.||participants|||Number
808486|NCT01033942|Primary|Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 4||Week 4|Not all participants answered every question||participants|||Number
801988|NCT00979017|Secondary|Median Progression-free Survival (PFS)|Time in months from the start of study treatment to the date of first progression according to RANO criteria, or to death due to any cause. Per RANO, progression is a ≥ 25% increase in the sum of the products of perpendicular diameters of enhancing lesions, worsening T2/FLAIR, any new lesion, or clinical deterioration. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve.|36 months|Intent-to-treat||months||95% Confidence Interval|Median
801989|NCT00979017|Secondary|Incidence of Grade ≥ 4 Hematologic and ≥ Grade 3 Non-hematologic Toxicities|Incidence of treatment-related, grade ≥ 4 hematologic and ≥ grade 3 non-hematologic toxicities- The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.|4 months|Intent-to-treat||participants|||Number
801990|NCT00979017|Secondary|Incidence and Severity of Central Nervous System (CNS) Hemorrhage and Systemic Hemorrhage|Incidence and severity of CNS hemorrhage and systemic hemorrhage- The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.|4 months|Intent-to-treat||participants|||Number
801991|NCT00979017|Primary|Response Rate|The percentage of participants with a complete or partial response as determined by a modification of the Response Assessment in Neuro-Oncology (RANO) criteria. Complete Response (CR) was defined as complete disappearance on MR/CT of all enhancing tumor and mass effect, off all corticosteroids (or receiving only adrenal replacement doses) and accompanied by a stable or improving neurologic examination. Partial Response (PR) was defined as greater than or equal to 50% reduction in tumor size on MR/CT by bi-dimensional measurement, on a stable or decreasing dose of corticosteroids and accompanied by a stable or improving neurologic examination. Per the criteria, confirmation of response was required. Response rate = CR+PR.|4 months|Intent-to-treat||percentage of participants||95% Confidence Interval|Number
801992|NCT00979069|Primary|Executive Language Functions|The Verbal Fluency Test is demonstrated to be reliable and valid among adults aged 50 to 89 (Delis, et al., 2001; Delis, Kramer, Kaplan, & Hodnack, 2004). The Verbal Fluency Test has three conditions, Letter Verbal Fluency, Category Verbal Fluency, and Switching Verbal Fluency. Each was randomized at pre- and post-12 week timeline and equated for difficulty. Letter Verbal Fluency assesses the number of words beginning with certain letters that participants can generate within 60 seconds,the Category Verbal Fluency assesses the number of words within particular categories participants can generate within 60 seconds, and the Switching Verbal Fluency assesses the number of words while alternating between different categories participants can generate within 60 seconds. For each condition (letter, category, and switching) a total score representing the total number of correct|number of correct words at pre and post separated by 12 weeks|||Mean outpoint by group at pre and post||Standard Deviation|Mean
801993|NCT00979121|Other Pre-specified|Changes in Plasma Concentrations of C-reactive Protein (CRP) From Baseline to Day 6 and Day 14|CRP levels were collected on subjects at baseline and on-study. The change in concentration from baseline levels to levels on study days 6 and 14 was analyzed. Those subjects that were still alive and on study at day 6 and 14 with a measured CRP level were included in the analysis.|6 and 14 days after randomization|||mg/dL||Standard Deviation|Mean
801994|NCT00979121|Other Pre-specified|Other Secondary Out-comes|Percentage of subjects with Arrhythmia's, Bowel Ischemia, Myocardial Infarction, Ischemic Stroke, and Thromboembolism were measured.|28 days after randomization|||percentage of participants||95% Confidence Interval|Number
801995|NCT00979121|Other Pre-specified|ICU Free Days to Day 28||28 days after randomization|||days||Standard Deviation|Mean
801996|NCT00979121|Other Pre-specified|Organ Failure Free Days at Day 14|The number of days from randomization to day 14 without an organ failure. Four main organ systems were measured: cardiovascular, coagulation, hepatic function, and renal function.|14 days after randomization|||days||Standard Deviation|Mean
801997|NCT00979121|Secondary|Ventilator Free Days at Study Day 28|Ventilator Free Days (VFDs) to day 28 were defined as the number of days from the time of initiating unassisted breathing to day 28 after randomization, assuming survival for at least two consecutive calendar days after initiating unassisted breathing and continued unassisted breathing to day 28. If a subject received assisted breathing at day 27 or died prior to day 28, a value of zero VFDs was given.|time of initiating unassisted breathing to day 28 after study randomization|||days||Standard Deviation|Mean
801998|NCT00979121|Primary|Hospital Mortality to Day 60.|The percentage of subjects alive at study day 60. Those subjects discharged home prior to day 60 were counted as alive at day 60.|60 days after randomization|||percentage of participants||95% Confidence Interval|Number
801999|NCT00979199|Secondary|Cost-benefit and Cost-effectiveness Analysis|Different non invasive imaging modalities are compared in terms of a cost-effectiveness analysis where costs include direct and indirect costs incurred as a consequence of the use of each modality or combination of modalities and effectiveness is the diagnostic accuracy with invasive diagnosis of IHD as end-point.|3 months||||||
802000|NCT00979199|Primary|Diagnosis of IHD at Invasive Coronary Angiography and FFR Measurement|The outcome measure is the number of participants who received the diagnosis of IHD at invasive coronary angiography coupled with FFR measurements (in case of intermediate coronary lesions).|3 months from enrollment|||participants|||Number
802001|NCT00979212|Secondary|Response Rate|Patients are assessed for best response to protocol treatment using the RECIST criteria. The response rate was calculated as the number of patients who have a complete response (CR) or partial response (PR) divided by the total number of analyzable patients at completion of induction chemoradiation +/- panitumumab and prior to anticipated surgery in each arm. Patients without a documented assessment are considered as not having a CR or PR. Rates are not compared across arms.|From date of randomization to time of protocol surgery, approximately 12 weeks.|All eligible patients who started study treatment||percentage of participants||95% Confidence Interval|Number
802002|NCT00979212|Secondary|Ability of FDG-PET/CT Scan Data to Predict Outcome|FDG-PET/CT scan data has not been obtained and therefore this outcome measure cannot be reported.|Patients are followed until death. Analysis occurs at time of primary analysis, approximately five years from start of study.||||||
802984|NCT00988442|Secondary|Change in CD4 Cell Count at Week 24|Change in CD4 cell count from baseline at Week 24, calculated as Week 24 CD4 minus baseline CD4.|Baseline and Week 24|Due to early study closure, only 42 participants had week 24 CD4 observations to be included in this analysis.||cells/mm^3||95% Confidence Interval|Mean
802003|NCT00979212|Secondary|Surgical Morbidities in Patients With Resectable Disease at Reassessment|A surgical morbidity is any toxicity occurring within 30 days of protocol surgery, as evaluated using CTCAE v4.0. Rates of grade 3 and higher surgical morbidity were calculated; the rates across arms were not compared.|From date of surgery to 30 days following surgery.|All eligible patients who started study treatment and received protocol surgery||percentage of patients||95% Confidence Interval|Number
802004|NCT00979212|Secondary|Percentage of Patients With Grade 3 or Higher Acute and Late Adverse Events|Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. Does not include surgical morbidities. An acute adverse event is defined as any grade 3 or worse toxicity occurring during protocol treatment and within 30 days from the end of protocol treatment that is possibly, probably, or definitely related to treatment. Acute adverse events are any adverse events occurring within 30 days of the end of all protocol treatment. Late adverse events are any adverse events occurring after 30 days after the end of all protocol treatment.|Patients are followed until death. Analysis occurs at time of primary analysis, approximately five years from start of study.|All eligible patients who started study treatment||percentage of participants||95% Confidence Interval|Number
802005|NCT00979212|Secondary|Patterns of First Failure|The first failure site will be tabulated, not compared.|Patients are followed until death. Analysis occurs at time of primary analysis, approximately five years from start of study.|All eligible patients who started study treatment||participants|||Number
802006|NCT00979212|Secondary|Overall Survival|Survival time was calculated from the date of randomization to the date of death from any cause or the date of last follow-up. The Kaplan-Meier method was used to estimate the overall survival rates. One-year survival rates were estimated, not compared.|Patients are followed until death. Analysis occurs at time of primary analysis, approximately five years from start of study|All eligible patients who started study treatment||percentage of participants||95% Confidence Interval|Number
802007|NCT00979212|Primary|Mediastinal Nodal Clearance After Completion of Induction Chemoradiotherapy With or Without Panitumumab.|The assessment of whether mediastinal nodes which were involved at the time of study registration were clear of disease following induction chemoradiotherapy with or without panitumumab; the assessment is made at the time of surgery 4-6 weeks after chemoradiation. If surgery could not be performed, the patient was considered as not having had mediastinal nodal clearance.|From date of randomization to time of protocol surgery, approximately 12 weeks.|All eligible patients who started study treatment||percentage of participants||95% Confidence Interval|Number
802008|NCT00979420|Secondary|Number of Participants With Drug Related Adverse Events|Number of participants with drug related Adverse Events (AEs)|Up to 185 months|Treated set||participants|||Number
802009|NCT00979420|Secondary|Course of Absolute CD4+ Cell Count|The course of absolute CD4+ cell count is presented as the absolute CD4+ cell count at last visit.|Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months|PPS: All patients from FAS without treatment interruptions and who are treated with Viramune for at least 10 years||CD4+ cells/mm3||Full Range|Median
802010|NCT00979420|Secondary|History of Therapy With Antiretroviral Medication|Participants with a history of therapy with antiretroviral medication.|Baseline|Treated set||participants|||Number
802011|NCT00979420|Secondary|Duration of Intake of Viramune|Duration of intake of Viramune|End of treatment, up to 185 months|Treated set||months||Full Range|Median
802012|NCT00979420|Secondary|Number of Patients With Laboratory Abnormalities for Hemoglobin During Study (Worst Grade) by DAIDS Grade|"Duration of intake of Viramune ranges from 14 to 185 months. The DAIDS AE Grading Table was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening."|Up to 185 months|Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of Hemoglobin.||Participants|||Number
802013|NCT00979420|Secondary|Number of Patients With Laboratory Abnormalities for Creatinine During Study (Worst Grade) by DAIDS Grade|"Duration of intake of Viramune ranges from 14 to 185 months. The DAIDS AE Grading Table was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening."|Up to 185 months|Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of Creatinine.||Participants|||Number
802014|NCT00979420|Secondary|Number of Patients With Laboratory Abnormalities for Aspartate Aminotransferase (AST) During Study (Worst Grade) by DAIDS Grade|"Duration of intake of Viramune ranges from 14 to 185 months. The DAIDS AE Grading Table was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening."|Up to 185 months|Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of AST||Participants|||Number
802015|NCT00979420|Secondary|Number of Patients With Laboratory Abnormalities for Alanine Aminotransferase (ALT) During Study (Worst Grade) by DAIDS Grade|"Duration of intake of Viramune ranges from 14 to 185 months. The DAIDS AE Grading Table was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening."|Up to 185 months|Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of ALT||Participants|||Number
802016|NCT00979420|Secondary|Number of Patients With Laboratory Abnormalities for Blood Glucose During Study (Worst Grade) by DAIDS Grade|"Duration of intake of Viramune ranges from 14 to 185 months. The DAIDS AE Grading Table was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening."|Up to 185 months|Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of blood glucose||Participants|||Number
802017|NCT00979420|Secondary|Number of Patients With Laboratory Abnormalities for Triglycerides During Study (Worst Grade) by DAIDS Grade|"Duration of intake of Viramune ranges from 14 to 185 months. The DAIDS AE Grading Table was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening."|Up to 185 months|Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of triglycerides.||Participants|||Number
802018|NCT00979420|Secondary|Number of Patients With Laboratory Abnormalities for Low-density Lipoprotein (LDL) Cholesterol During Study (Worst Grade) by DAIDS Grade|"Duration of intake of Viramune ranges from 14 to 185 months. The DAIDS AE Grading Table was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening."|Up to 185 months|Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of LDL cholesterol.||Participants|||Number
802019|NCT00979420|Secondary|Number of Patients With Laboratory Abnormalities for Cholesterol During Study (Worst Grade) by Division of AIDS (DAIDS) Grade|"Duration of intake of Viramune ranges from 14 to 185 months. The DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table) was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening."|Up to 185 months|Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of cholesterol.||Participants|||Number
802020|NCT00979420|Primary|Change in Absolute CD4 Lymphocytes (CD4+ Cells) From Baseline to Last Visit|Baseline is defined as the last documentation before start of therapy with Viramune. The change from baseline reflects the last available number of CD4+ cells minus the baseline number of CD4+ cells.|Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.|PPS: All patients from FAS without treatment interruptions and who are treated with Viramune for at least 10 years.||CD4+ cells/mm3||Full Range|Median
802021|NCT00979420|Primary|Number of Participants With Viral Load <50 Copies/ml and >=50 Copies/ml at Last Visit||Last available visit. Duration of intake of Viramune ranges from 14 to 185 months.|PPS: All patients from FAS without treatment interruptions and who are treated with Viramune for at least 10 years.||Participants|||Number
802022|NCT00979420|Primary|Change in log10 Viral Load From Baseline to Last Visit|Baseline is defined as the last documentation before start of therapy with Viramune. The change from baseline reflects the last available visit viral load minus the baseline viral load.|Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.|Per protocol set (PPS): All patients from FAS without treatment interruptions and who are treated with Viramune for at least 10 years.||log10 copies/ml||Full Range|Median
802023|NCT00979420|Primary|Change in Absolute CD4 Lymphocytes (CD4+) Cells From Baseline to Last Visit|Baseline is defined as the last documentation before start of therapy with Viramune. The change from baseline reflects the last available number of CD4+ cells minus the baseline number of CD4+ cells.|Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.|FAS: This patient set includes all patients from TS who have documented at least one value for the viral load before start of therapy with Viramune.||CD4+ cells/mm3||Full Range|Median
802024|NCT00979420|Primary|Number of Participants With Viral Load <50 Copies/ml and >=50 Copies/ml at Last Visit||Last available visit. Duration of intake of Viramune ranges from 14 to 185 months.|FAS: This patient set includes all patients from TS who have documented at least one value for the viral load before start of therapy with Viramune.||Participants|||Number
802025|NCT00979420|Primary|Change in log10 Viral Load From Baseline to Last Visit|Baseline is defined as the last documentation before start of therapy with Viramune. The change from baseline reflects the last available visit viral load minus the baseline viral load.|Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.|Full analysis set (FAS): This patient set includes all patients from Treated Set (TS) who have documented at least one value for the viral load before start of therapy with Viramune.||log10 copies/ml||Full Range|Median
802026|NCT00979459|Secondary|Number of Participants Who Discontinued Study Medication Due to an Adverse Event||up to 8 days|All participants received both formulations of MK-1006, FCT and DFC, and appear in both treatment groups.||participants|||Number
802027|NCT00979459|Secondary|Number of Participants Who Experienced at Least One Adverse Event||Through 30 days post-dose|All participants received both formulations of MK-1006, FCT and DFC, and appear in both treatment groups.||participants|||Number
802028|NCT00979459|Primary|Maximum Plasma Concentration (Cmax) for MK-1006|Maximum plasma concentration for 2 formulations of MK-1006, FCT and DFC|Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 120 hours post-dose|||nM||95% Confidence Interval|Geometric Mean
802029|NCT00979459|Primary|Area Under the Concentration Versus Time Curve (AUC(0-infinity)) for MK-1006|AUC (0-infinity) is the area under the curve for the plot showing plasma concentration against time from time zero to the time of the last quantifiable concentration for two formulations of MK-1006, FCT and DFC|Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 120 hours post-dose|||nM*hr||95% Confidence Interval|Geometric Mean
802030|NCT00979576|Secondary|Cmax of Pemetrexed|Maximum measured concentration of pemetrexed in plasma (Cmax)|5 minutes (min) before pemetrexed administration and 10min, 40min, 1 hour (h), 2h, 4h, 6h, 23h 55min, 47h 55min after pemetrexed administration in cycles 1 and 2|PK set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
802031|NCT00979576|Secondary|AUC0-inf of Pemetrexed|Area under the concentration-time curve of pemetrexed in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf)|5 minutes (min) before pemetrexed administration and 10min, 40min, 1 hour (h), 2h, 4h, 6h, 23h 55min, 47h 55min after pemetrexed administration in cycles 1 and 2|PK set||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
802032|NCT00979576|Secondary|Cmax of Nintedanib|Maximum measured concentration of nintedanib in plasma (Cmax)|5 minutes (min) before nintedanib administration and 1h, 2h, 3h, 4h, 6h, 7h, 10h and 23h 55min after nintedanib administration in cycle 1|PK set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
802033|NCT00979576|Secondary|AUC0-inf of Nintedanib|Area under the concentration-time curve of nintedanib in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf)|5 minutes (min) before nintedanib administration and 1h, 2h, 3h, 4h, 6h, 7h, 10h and 23h 55min after nintedanib administration in cycle 1|Pharmacokinetic (PK) set||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
802034|NCT00979576|Secondary|Number of Participants With Clinically Relevant Abnormalities in Laboratory Parameters|Number of participants with clinically relevant abnormalities in laboratory parameters reported as adverse events which occurred in >= 20% of patients|Between first administration of pemetrexed and 28 days after last administration of pemetrexed and/or BIBF 1120, up to 1020 days|Treated set||participants|||Number
808841|NCT01038323|Secondary|Change in Evoked Pain Scores|0 to 20 pain scale, with higher pain score representing greater sensitivity to pressure pain stimuli|Baseline and Week 21 clinic visits|||units on a scale||Standard Error|Mean
802035|NCT00979576|Secondary|Duration of Disease Control|Duration of disease control was defined as the time period from the first study drug administration to the progressive disease (PD) or death of patients, whichever occurred earlier.|From first study drug administration until PD or death, up to 1003 days|Patients from the treated set who achieved disease control||Days||Full Range|Median
802036|NCT00979576|Secondary|Disease Control Rate|Number of participants with complete response (CR), partial response (PR) or stable disease (SD) according to the Response Evaluation Criteria In Solid Tumors (RECIST) 1.0|Every 6 weeks after start of study treatment until end of treatment, up to 992 days|Treated set||Participants|||Number
802037|NCT00979576|Secondary|Overall Response Rate|Number of participants with complete response (CR) or partial response (PR) according to the Response Evaluation Criteria In Solid Tumors (RECIST) 1.0|Every 6 weeks after start of study treatment until end of treatment, up to 992 days|Treated set||Participants|||Number
802038|NCT00979576|Primary|Adverse Events According to Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 for All Courses|"Number of patients with adverse events according to worst Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 for all courses.
CTCAE grades are: 1 (mild AE), 2 (moderate AE), 3 (severe AE), 4 (life-threatening or disabling AE) or 5 (death related to AE)."|Between first administration of pemetrexed and 28 days after last administration of pemetrexed and/or BIBF 1120, up to 1020 days|Treated set||participants|||Number
802039|NCT00979576|Primary|Dose Limiting Toxicities|Number of participants with dose limiting toxicity (DLT) in combination therapy of BIBF 1120 and pemetrexed during the first course|During the first course, 21 days|Treated set||Participants|||Number
802040|NCT00979602|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Throughout the entire study period (Day 0 - Day 385)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Participants|||Count of Participants
802041|NCT00979602|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within the 42-day (Days 0-41) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Participants|||Count of Participants
802042|NCT00979602|Secondary|Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) represent a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|Throughout the entire study period (Day 0 - Day 385)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Participants|||Count of Participants
802043|NCT00979602|Secondary|Number of Subjects With Any Medically-attended Adverse Events (MAEs)|MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.|Throughout the entire study period (Day 0 - Day 385)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Participants|||Count of Participants
802044|NCT00979602|Secondary|Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels|Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], alkaline phosphatase [AP], aspartate aminotransferase [AST], basophils [BAS], total bilirubin [T/BIL], bilirubin direct [BIL/D], creatinine [CREA], eosinophils [EOS], hematocrit [HEM], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], plateles [PLA], red blood cells [RBC], blood urea nitrogen [BUN] and white blood cells [WBC. Levels of haematological/biochemical parameters assessed with respect to normal laboratory values were – unknown, below, within and above for subjects aged 18-64 years (18-64y) and >64 years old (>64y).|At Days 7 and 21|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Participants|||Count of Participants
802045|NCT00979602|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, fever [defined as axillary temperature equal to or above (≥) 38.0 degrees Celsius (°C)], headache, joint pain at other location, muscle aches, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who filled in their symptom sheets.||Participants|||Count of Participants
802046|NCT00979602|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who filled in their symptom sheets.||Participants|||Count of Participants
802047|NCT00979602|Secondary|Number of ILI Symptoms in All Reported ILI Cases|Assessed ILI symptoms were fever [defined as oral temperature equal to or above (≥) 38.5 degrees Celsius (°C)], myalgia (muscle aches all over the body), cough, sore throat, runny/stuffy nose, short of breath, headache, vomiting, diarrhea, chills, fatigue.|From Day 14 post-vaccination through the end of ILI surveillance (Day 385)|The analysis was performed on the ATP cohort for efficacy, which included all eligible subjects who received the study vaccine according to their treatment assignment and who were successfully contacted at least once during the active influenza surveillance period after completing the Day 21 study visit.||Events|||Number
802216|NCT00981214|Secondary|Percentage of Blood in Stool|Mean percentage of stools with blood at each period for total participants was summarized.|Baseline, Day 5 up to Day 11 (dose stabilization period), Day 12 up to Day 18 (treatment period)|Analysis population set included all participants who received at least 1 dose of study.||percentage of stools||Standard Deviation|Mean
802048|NCT00979602|Secondary|Number of ILI Symptoms in All Reported ILI Cases|Assessed ILI symptoms were fever [defined as oral temperature equal to or above (≥) 38.5 degrees Celsius (°C)], myalgia (muscle aches all over the body), cough, sore throat, runny/stuffy nose, short of breath, headache, vomiting, diarrhea, chills, fatigue.|From Day 0 up to the end of ILI surveillance (Day 385)|The analysis was performed on the ATP cohort for efficacy, which included all eligible subjects who received the study vaccine according to their treatment assignment and who were successfully contacted at least once during the active influenza surveillance period after completing the Day 21 study visit.||Events|||Number
802049|NCT00979602|Secondary|Number of A/California Influenza Related Cases|Influenza related cases included: A/California/7/2009 (H1N1)v-like influenza illness (ILI) cases, pneumonia cases, RT-qPCR confirmed influenza, culture confirmed influenza and RT-qPCR confirmed influenza with pneumonia.|From Day 0 up to the end of ILI surveillance (Day 385)|The analysis was performed on the ATP cohort for efficacy, which included all eligible subjects who received the study vaccine according to their treatment assignment and who were successfully contacted at least once during the active influenza surveillance period after completing the Day 21 study visit.||Events|||Number
802050|NCT00979602|Secondary|Seroconversion Factor (SCF) for HI Antibodies Against A/CAL/7/09 H1N1 Virus Strain|SCF was defined as the fold increase in serum HI geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus, in subjects 18-60 years and older and 18-64 years and older, following the CHMP.|At Day 182|The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 182 were available.||Fold increase||95% Confidence Interval|Geometric Mean
802051|NCT00979602|Secondary|Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain|SCF was defined as the fold increase in serum HI geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus, in subjects 18-60 years and older and 18-64 years and older, following the CHMP.|At Day 42|The analysis was performed on a subset from the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 42 were available.||Fold increase||95% Confidence Interval|Geometric Mean
802052|NCT00979602|Secondary|Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain|A seroprotected subject was defined as a vaccinated subject with serum HI antibody titer ≥ 1:40. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.|At Day 182|The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 182 were available.||Participants|||Count of Participants
802053|NCT00979602|Secondary|Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain|A seroprotected subject was defined as a vaccinated subject with serum HI antibody titer ≥ 1:40. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.|At Day 42|The analysis was performed on a subset from the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 42 were available.||Participants|||Count of Participants
802054|NCT00979602|Secondary|Number of Seroconverted (SCR) Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain|A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer ≥1:40 and at least a 4-fold increase of the pre-vaccination titer. The Flu strain assessed was A/California/7/09 (H1N1)v-like) (Flu A/CAL/7/09) in subjects of 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.|At Day 182|The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 182 were available.||Participants|||Count of Participants
802055|NCT00979602|Secondary|Number of Seroconverted (SCR) Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain|A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer ≥1:40 and at least a 4-fold increase of the pre-vaccination titer. The Flu strain assessed was A/California/7/09 (H1N1)v-like) (Flu A/CAL/7/09) in subjects of 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.|At Day 42|The analysis was performed on a subset from the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 42 were available.||Participants|||Count of Participants
802056|NCT00979602|Secondary|Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain|Titers were presented as geometric mean titers (GMTs). The flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.|At Day 182|The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 182 were available.||Titers||95% Confidence Interval|Geometric Mean
802057|NCT00979602|Secondary|Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain|Cut-off values assessed were greater than or equal to ≥ 1:10 in the sera of subjects seronegative before vaccination. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.|At Day 182|The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 182 were available.||Participants|||Count of Participants
802058|NCT00979602|Secondary|Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain|Titers were presented as geometric mean titers (GMTs). The flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.|At Day 42|The analysis was performed on a subset from the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 42 were available.||Titers||95% Confidence Interval|Geometric Mean
802059|NCT00979602|Secondary|Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain|Cut-off values assessed were greater than or equal to (≥) 1:10 in the sera of subjects seronegative before vaccination. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.|At Day 42|The analysis was performed on a subset from the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 42 were available.||Participants|||Count of Participants
802060|NCT00979602|Secondary|Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain|Titers were presented as geometric mean titers (GMTs). The flu strain assessed was /California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.|At Days 0 and 21|The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 21 were available.||Titers||95% Confidence Interval|Geometric Mean
802061|NCT00979602|Secondary|Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain|"Cut-off values assessed were greater than or equal to (≥) 1:10 in the sera of subjects seronegative before vaccination.
The Flu strains assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance."|At Days 0 and 21|The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 21 were available.||Participants|||Count of Participants
802062|NCT00979602|Primary|Number of A/California/7/2009 (H1N1)V-like Illness (ILI) Cases|The analysis focused on Quantitative Reverse Transcription Polymerase Chain Reaction Assay (RT-qPCR)-confirmed A/California/7/2009 (H1N1)v-like illness (ILI) cases.|From Day 14 post-vaccination up to study end (at Day 385)|The analysis was performed on the ATP cohort for efficacy, which included all eligible subjects who received the study vaccine according to their treatment assignment and who were successfully contacted at least once during the active influenza surveillance period after completing the Day 21 study visit.||Events|||Number
802063|NCT00979602|Primary|Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain|SCF was defined as the fold increase in serum HI geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus, in subjects 18-60 years and older and 18-64 years and older, following the CHMP guidance.|At Day 21|The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 21 were available.||Fold increase||95% Confidence Interval|Geometric Mean
802064|NCT00979602|Primary|Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain|A seroprotected subject was defined as a vaccinated subject with serum HI antibody titer ≥ 1:40. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.|At Day 21|The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 21 were available.||Participants|||Count of Participants
802065|NCT00979602|Primary|Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) antibody titer ≥ 1:40 against the tested virus. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.|At Day 0|The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 21 were available.||Participants|||Count of Participants
802066|NCT00979602|Primary|Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain|A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer higher than or equal to (≥)1:40 or at least a 4-fold increase of the pre-vaccination titer of ≥ 1:10. The Flu strain assessed was A/California/7/09 (H1N1)v-like (Flu A/CAL/7/09) in subjects of 18-60 years and older and 18-64 years and older, following the Committee for Medicinal Products for Human Use (CHMP) and the Center for Biologics Evaluation and Research (CBER) guidance.|At Day 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 21 were available.||Participants|||Count of Participants
802081|NCT00979654|Secondary|Maximum Observed Serum Concentration (Cmax) for Sifalimumab|The Cmax is the maximum observed plasma concentration of sifalimumab.|Pre-infusion and End of Infusion on Day 1|The PK Population included all participants who received at least one dose of investigational product and had at least one evaluable sifalimumab serum concentration. Here, “N” is number of participants analyzed for this outcome measure.||microgram per milliliter (mcg/mL)||Standard Deviation|Mean
802272|NCT00974051|Secondary|Percent of Nighttime Glucose Levels <70||10:00pm to 6:00am|||percentage of nighttime glucose values|||Number
802067|NCT00979615|Secondary|Mean Change in Sneezing Reflective Score|Change from baseline after 2 weeks in responses to patient-completed diaries for reflective Total Nasal VMR Symptom Scores (rTVSS). TVSS is composed of 4 individual assessments, which included nasal congestion, rhinorrhea, post nasal drip and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are totaled for a composite score (TVSS score), the maximum of which could be 12. Reflective scores were assessed from the hour since the last dose of study medication.|2 Weeks|||Units on a scale||Standard Deviation|Mean
802068|NCT00979615|Secondary|Mean Change Nasal Congestion Reflective Score|Change from baseline after 2 weeks in responses to patient-completed diaries for reflective Total Nasal VMR Symptom Scores (rTVSS). TVSS is composed of 4 individual assessments, which included nasal congestion, rhinorrhea, post nasal drip and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are totaled for a composite score (TVSS score), the maximum of which could be 12. Reflective scores were assessed from the hour since the last dose of study medication.|2 Weeks|||Units on a scale||Standard Deviation|Mean
802069|NCT00979615|Secondary|Mean Change Postnasal Drip Reflective Score|Change from baseline after 2 weeks in responses to patient-completed diaries for reflective Total Nasal VMR Symptom Scores (rTVSS). TVSS is composed of 4 individual assessments, which included nasal congestion, rhinorrhea, post nasal drip and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are totaled for a composite score (TVSS score), the maximum of which could be 12. Reflective scores were assessed from the hour since the last dose of study medication.|2 Weeks|||Units on a scale||Standard Deviation|Mean
802070|NCT00979615|Secondary|Mean Change in Rhinorrhea Reflective Score|Change from baseline after 2 weeks in responses to patient-completed diaries for reflective Total Nasal VMR Symptom Scores (rTVSS). TVSS is composed of 4 individual assessments, which included nasal congestion, rhinorrhea, post nasal drip and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are totaled for a composite score (TVSS score), the maximum of which could be 12. Reflective scores were assessed from the hour since the last dose of study medication.|2 week|||Units on a scale||Standard Deviation|Mean
802071|NCT00979615|Primary|Mean Change in 2-week rTNSS From Baseline|Change from baseline after 2 weeks in responses to patient-completed diaries for reflective Total Nasal VMR Symptom Scores (rTVSS). TVSS is composed of 4 individual assessments, which included nasal congestion, rhinorrhea, post nasal drip and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are totaled for a composite score (TVSS score), the maximum of which could be 12. Reflective scores were assessed from the hour since the last dose of study medication.|2 week|||Units on a scale||Standard Deviation|Mean
802072|NCT00979628|Secondary|To Determine Differences Between Treatments Arms in # of Hypoglycemic Events||during hospitalization||||||
802073|NCT00979628|Primary|To Determine Glycemic Control Between Basal Plus(Glargine Once Daily Plus Corrective Doses of Glulisine Before Meals and Bedtime as Needed), Basal Bolus Approach of Glargine Once Daily Plus Glulisine Before Meals and SSRI||during hospitalization|||mg/dl||Standard Deviation|Mean
802074|NCT00979654|Secondary|Number of Participants With Positive Anti-Drug Antibody|Participants tested for immunogenicity to Sifalimumab (MEDI-545) from Day 1 to the end of study.|Day 1 and Week 12, 24, 52, 104, 156 and 168|Safety Population included all participants who received at least one dose of investigational product.||Participants|||Number
802075|NCT00979654|Secondary|Accumulation Index for Minimum Observed Serum Concentration (Ctrough) of Sifalimumab|The Ctrough is the minimum observed serum concentration of sifalimumab. Accumulation Index is calculated as Ctrough value at steady state divided by Ctrough value after first dose.|Pre-infusion and End of Infusion on Day 1 and Week 2, 4, 8, 12, 24, 52, 104, 156 and 168|The PK Population included all participants who received at least one dose of investigational product and had at least one evaluable sifalimumab serum concentration. Here, “N” is number of participants analyzed for this outcome measure.||ratio||Standard Deviation|Mean
802076|NCT00979654|Secondary|Minimum Observed Serum Concentration at Steady State (Ctrough,ss) of Sifalimumab|The Ctrough is the minimum observed serum concentration at steady state of sifalimumab.|Pre-infusion and End of Infusion on Day 1 and Week 2, 4, 8, 12, 24, 52, 104, 156 and 168|The PK Population included all participants who received at least one dose of investigational product and had at least one evaluable sifalimumab serum concentration. Here, “N” is number of participants analyzed for this outcome measure.||mcg/mL||Standard Deviation|Mean
802077|NCT00979654|Secondary|Area Under the Serum Concentration-time Curve Over the Dosing Interval (AUCtau) of Sifalimumab|The AUCtau is the area under the serum concentration-time curve over the dosing interval of sifalimumab.|Pre-infusion and End of Infusion on Day 1|The PK Population included all participants who received at least one dose of investigational product and had at least one evaluable sifalimumab serum concentration. Here, “N” is number of participants analyzed for this outcome measure.||microgram.day per milliliter(mcg*day/mL)||Standard Deviation|Mean
802078|NCT00979654|Secondary|Minimum Observed Serum Concentration (Ctrough) of Sifalimumab|The Ctrough is the minimum observed serum concentration of sifalimumab.|Pre-infusion and End of Infusion on Day 1|The PK Population included all participants who received at least one dose of investigational product and had at least one evaluable sifalimumab serum concentration. Here, “N” is number of participants analyzed for this outcome measure.||mcg/mL||Standard Deviation|Mean
802079|NCT00979654|Secondary|Time to Last Quantifiable Plasma Concentration (Tlast) of Sifalimumab|The Tlast is the time to last quantifiable plasma concentration (Tlast) of sifalimumab.|Pre-infusion and End of Infusion on Day 1|The PK Population included all participants who received at least one dose of investigational product and had at least one evaluable sifalimumab serum concentration. Here, “N” is number of participants analyzed for this outcome measure.||days||Standard Deviation|Mean
802080|NCT00979654|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Sifalimumab|The Tmax is the time to reach maximum observed plasma concentration of sifalimumab.|Pre-infusion and End of Infusion on Day 1|The PK Population included all participants who received at least one dose of investigational product and had at least one evaluable sifalimumab serum concentration. Here, “N” is number of participants analyzed for this outcome measure.||days||Full Range|Median
802128|NCT00980174|Secondary|Trochanter Bone Mineral Density Percent Change From Baseline at Month 12||From Baseline to 12 Months|||Percent||95% Confidence Interval|Mean
802082|NCT00979654|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received investigational product. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of investigational product and 30 days after the last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state.|From start of study drug administration until week 182|Safety Population included all participants who received at least one dose of investigational product.||participants|||Number
802083|NCT00979875|Secondary|Time to Percentage of Total Insulin Exposure|Time to 10% and 50% of total insulin exposure was measured. Samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); every 5 mins (from 15 to 30 mins); every 15 mins (from 30 to 90 mins); every 30 mins (from 90 to 240 mins); and every 60 mins (from 240 to 480 mins) after each injection.|Predose up to 480 minutes postdose|Participants who received at least one dose of Lispro alone, Lispro + rHuPH20, Glulisine alone, Glulisine + recombinant human hyaluronidase PH20 (rHuPH20), Aspart alone, or Aspart + rHuPH20 with evaluable total insulin exposure data.||minutes||Standard Deviation|Mean
802084|NCT00979875|Secondary|Percentage of Total Area Under the Concentration-time Curve for Serum Insulin Attained by Time t (AUC0-t)|Percentage of total area under the concentration (AUC)-time curve at 15, 30, 60, 120 minutes after injection was measured. Blood samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); every 5 mins (from 15 to 30 mins); every 15 mins (from 30 to 90 mins); and at 90 and 120 mins after each injection.|Predose up to 120 minutes postdose|Participants who received at least one dose of Lispro alone, Lispro + recombinant human hyaluronidase PH20 (rHuPH20) , Glulisine alone, Glulisine + rHuPH20, Aspart alone, or Aspart + rHuPH20 with evaluable AUC0-t data.||percentage of total AUC||Standard Deviation|Mean
802085|NCT00979875|Secondary|Time to Maximum Glucose Infusion Rate (tGIR[Max])|Blood samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); every 5 mins (from 15 to 30 mins); every 15 mins (from 30 to 90 mins); every 30 mins (from 90 to 240 mins); and every 60 mins (from 240 to 480 mins) after each injection.|Predose up to 480 minutes postdose|Participants who received at least one dose of Lispro alone, Lispro + recombinant human hyaluronidase PH20 (rHuPH20), Glulisine alone, Glulisine + rHuPH20, Aspart alone, or Aspart + rHuPH20 with evaluable tGIR(max) data.||minutes||Standard Deviation|Mean
802086|NCT00979875|Secondary|Time to Early and Late 50% Maximum Serum Insulin Concentration (t[50%Max])|Blood samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); every 5 mins (from 15 to 30 mins); every 15 mins (from 30 to 90 mins); every 30 mins (from 90 to 240 mins); and every 60 mins (from 240 to 480 mins) after each injection.|Predose up to 480 minutes postdose|Participants who received at least one dose of Lispro alone, Lispro + recombinant human hyaluronidase PH20 (rHuPH20), Glulisine alone, Glulisine + rHuPH20, Aspart alone, or Aspart + rHuPH20 with evaluable t(50%max) data.||minutes||Standard Deviation|Mean
802087|NCT00979875|Secondary|Time to Maximum Serum Insulin Concentration (Tmax)|Tmax was determined as the timepoint where the maximum of all valid concentration measurements for each measurement series was observed. Samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); every 5 mins (from 15 to 30 mins); every 15 mins (from 30 to 90 mins); every 30 mins (from 90 to 240 mins); and every 60 mins (from 240 to 480 mins) after each injection.|Predose up to 480 minutes postdose|Participants who received at least one dose of Lispro alone, Lispro + recombinant human hyaluronidase PH20 (rHuPH20), Glulisine alone, Glulisine + rHuPH20, Aspart alone, or Aspart + rHuPH20 with evaluable tmax data.||minutes||Standard Deviation|Mean
802088|NCT00979875|Primary|Area Under the Concentration-time Curve for Serum Insulin From Time 0 to 60 Minutes (AUC0-60)|Area under the concentration (AUC)-time curve was derived as the area under the serum insulin concentration profile from 0 to 60 minutes. Blood samples were taken 30, 20, and 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); and at 20, 25, 30, 45, and 60 mins after each injection.|Predose up to 60 minutes postdose|Participants who received at least one dose of Lispro alone, Lispro + recombinant human hyaluronidase PH20 (rHuPH20), Glulisine alone, Glulisine + rHuPH20, Aspart alone, or Aspart + rHuPH20 with evaluable AUC0-60 data.||minutes*nanomolars (min*nM)||Standard Deviation|Mean
802089|NCT00979901|Secondary|Mean Change From Baseline in Rhinoconjunctivitis Quality-of-life Questionnaire (RQLQ) Overall Score at Week 2|Patients completed the validated, self-administered RQLQ, which included 28 items on a 7-point scale across 7 domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. Scores for each domain were averaged, then scores for the 7 domains were averaged for the overall score. Scores were measured as 0 (best) to 6 (worst).|Week 2|This secondary endpoint analysis was performed using the intention-to-treat approach. Patients were excluded if no baseline or treatment period data were available. No missing values were imputed.||Units on a Scale||95% Confidence Interval|Least Squares Mean
802090|NCT00979901|Secondary|Physician's Global Evaluation of Allergic Rhinitis at Week 2|An evaluation by the physician, administered at the last visit (or upon discontinuation) using a 7-point scale, of the change in symptoms as compared to the beginning of the study. Scores were measured as 0 (best) to 6 (worst).|Week 2|This secondary endpoint analysis was performed using the intention-to-treat approach. Patients were excluded if no treatment period data were available. No missing values were imputed.||Units on a Scale||95% Confidence Interval|Least Squares Mean
802091|NCT00979901|Secondary|Patient's Global Evaluation of Allergic Rhinitis at Week 2|"An evaluation by the patient, administered at the last visit (or
upon discontinuation) using a 7-point scale, of the change in symptoms as compared to the beginning of the
study. Scores were measured as 0 (best) to 6 (worst)."|Week 2|This secondary endpoint analysis was performed using the intention-to-treat approach. Patients were excluded if no treatment period data were available. No missing values were imputed.||Units on a Scale||95% Confidence Interval|Least Squares Mean
802129|NCT00980174|Secondary|Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 12||From Baseline to 12 Months|||Percent||95% Confidence Interval|Mean
802130|NCT00980174|Secondary|Total Hip Bone Mineral Density Percent Change From Baseline at Month 12||From Baseline to 12 Months|||Percent||95% Confidence Interval|Mean
802092|NCT00979901|Secondary|Mean Change From Baseline in Daytime Eye Symptoms Score Over 2 Weeks|"Mean change from baseline in Daytime Eye Symptoms scores.
Patients were asked to rate each of the 4 eye symptoms of tearing, itchy, red, and puffy eyes daily on a 4-point scale. The average of the 4 individual eye symptoms scores was reported as the Daytime Eye Symptoms Score. Scores were measured as 0 (best) to 3 (worst)."|Baseline and Week 2|The secondary efficacy analyses were based on the ITT (all-patients treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.||Units on a Scale||95% Confidence Interval|Least Squares Mean
802093|NCT00979901|Secondary|Mean Change From Baseline in Nighttime Symptoms Score Over 2 Weeks|"Mean change from baseline in Nighttime Symptoms Score.
Patients were asked to rate each symptom daily on a 4-point scale, and the combined score of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings was reported as the Nighttime Symptoms Score. Scores were measured as 0 (best) to 3 (worst)."|Baseline and Week 2|The secondary efficacy analyses were based on the ITT (all-patients treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.||Units on a Scale||95% Confidence Interval|Least Squares Mean
802094|NCT00979901|Primary|Mean Change From Baseline in Daytime Nasal Symptoms Score Over 2 Weeks|"Mean change from baseline in Daytime Nasal Symptoms score.
Patients were asked to rate each of the 4 nasal symptoms of Congestion, Rhinorrhea, Itching, and Sneezing daily
on a 4-point scale. The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal
Symptoms Score. Scores were measured as 0 (best) to 3 (worst)."|Baseline and Week 2|The primary efficacy analysis was based on the ITT (all-patients treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.||Units on a Scale||95% Confidence Interval|Least Squares Mean
802095|NCT00979940|Primary|Periprocedural Myonecrosis||16-24 hours post PCI|||participants|||Number
802096|NCT00979953|Primary|Change From Baseline in the Average Pain Score (NPRS) for Week 2|The mean of the daily average scores were calculated from the NPRS pain assessment for the previous 24 hours obtained once a day for at least 4 days from Day -6 through Day 1 (Baseline assessment) and everyday from Day 2 through Day 15 (Treatment Phase assessment). The NPRS is an 11-point scale (0 to 10) with 0 indicating no pain and 10 indicating the worst possible pain.|Baseline, Week 2|All participants who received at least 1 dose of study medication and had at least evaluable 1 NPRS postdose measurement. Last-observation-carried-forward (LOCF) was used to impute missing postbaseline values.||units on a scale||Standard Deviation|Least Squares Mean
802097|NCT00979992|Other Pre-specified|Changes in Serum and Plasma Angiogenesis Markers by Enzyme-linked Immunosorbent Assays||Baseline to up to 5 years||||||
802098|NCT00979992|Other Pre-specified|Change in Pro-angiogenic Protein Levels||Baseline to up to 5 years||||||
802099|NCT00979992|Secondary|Number of Participants With Grade 3 or Higher Adverse Events|Grade 3 or higher adverse events were graded by CTC AE v 4.|Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.|Eligible and treated patients||participants|||Number
802100|NCT00979992|Secondary|Progression-free Survival|Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression was based on RECIST 1.1|Tumor scans were done every other cycle for the first 6 months; then every 3 months x 2; then every 6 months thereafter for up to 5 years.|Eligible and treated patients.||months||90% Confidence Interval|Median
802101|NCT00979992|Secondary|Overall Survival|Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.|Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years.|Eligible and treated patients.||months||90% Confidence Interval|Median
802102|NCT00979992|Primary|The Percentage of Patients Who Survive Progression Free for at Least 6 Months|Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression was based on RECIST 1.1. RECIST 1.1 defines progressive disease as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions or unequivocal progression of non-target lesions is also considered progression.|CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months|Eligible and treated patients.||percentage of participants||90% Confidence Interval|Number
802103|NCT00979992|Primary|Objective Tumor Response Rate (Complete and Partial Response)|Complete and Partial Tumor Response by RECIST 1.1. RECIST 1.1 defines complete response as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm and the disappearance of all non-target lesions and normalization of tumor marker level. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Only those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.|CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; then every 3 months x 2; then every 6 months thereafter until disease progression for up to 5 years.|Eligible and treated patients||percentage of participants||90% Confidence Interval|Number
802104|NCT00980005|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs).|An SAE is defined as any untoward medical occurrence in a patient or clinical investigation subject that: results in death, is lifethreatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.|During the entire study period (From Day 0 up to Day 180).|The Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
802105|NCT00980005|Secondary|Number of Subjects Reporting Medically Attended Adverse Events (MAEs).|For each solicited and unsolicited symptom the subject experiences, the subject/subject’s parent(s)/ Legally Acceptable Representative (LAR(s)) was asked if they received medical attention defined as hospitalisation, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason.|During the entire study period (From Day 0 up to Day 180).|The Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
802106|NCT00980005|Secondary|Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs), by Age-strata.|"Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any ‘solicited’ symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.
Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years.
Grade 3 = event that prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination."|During a 28 day follow-up period (Days 0-27) after vaccination.|The Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
802107|NCT00980005|Secondary|Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs).|"Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any ‘solicited’ symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.
Grade 3 = event that prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination."|During a 28 day follow-up period (Days 0-27) after vaccination.|The Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
802108|NCT00980005|Secondary|Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata.|"Solicited local symptoms assessed were pain, redness and swelling.
Any = occurrence of any solicited general symptom regardless of intensity grade.
Grade 3 pain = pain that prevented normal activity. Grade 3 redness, swelling = redness, swelling above 100 millimeter (mm).
All solicited local AEs were considered to be causally related to vaccination.
Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years."|During a 4-day follow-up period (Days 0-3) after vaccination.|The Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
802109|NCT00980005|Secondary|Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs).|"Solicited local symptoms assessed were pain, redness and swelling.
Any = occurrence of any solicited general symptom regardless of intensity grade.
Grade 3 pain = pain that prevented normal activity. Grade 3 redness, swelling = redness, swelling above 100 millimeter (mm).
All solicited local AEs were considered to be causally related to vaccination."|During a 4-day follow-up period (Days 0-3) after vaccination.|The Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
802110|NCT00980005|Secondary|Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs).|"The general symptoms solicited from study subjects 5 years of age and older were arthralgia (joint pain), fatigue, headache, muscle aches, shivering, and fever(= axillary temperature equal to or above 38.0 degrees Celsius (°C)).
Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to vaccination.
Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 temperature = axillary temperature ≥ 39.0°C and ≤ 40.0°C.
Related = symptom assessed by the investigator as causaly related to the vaccination."|During a 4-day follow-up period (Days 0-3) after vaccination.|The Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
802111|NCT00980005|Secondary|Number of Subjects Below 5 Years of Age With Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs).|"The general symptoms solicited from study subjects younger than 5 years of age were drowsiness, irritability, loss of appetite, and fever(= axillary temperature equal to or above 38.0 degrees Celsius (°C)).
Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to vaccination.
Grade 3 drowsiness, irritability = symptom that prevented normal activity. Grade 3 loss of appetite = not eating at all.
Grade 3 temperature = axillary temperature ≥ 39.0°C and ≤ 40.0°C.
Related = symptom assessed by the investigator as causally related to the vaccination."|During a 4-day follow-up period (Days 0-3) after vaccination.|The Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
802112|NCT00980005|Secondary|Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains, by Age-strata.|"The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.
Seroconversion factor (SCF) was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination.
Seroconversion factor (SCF) was defined as the geometric mean of the within subjects ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. SCFs were calculated at Day 28 following the complete vaccination regimen.
Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years."|At Day 0 and at Day 28 after last vaccine dose|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination.||Fold increase||95% Confidence Interval|Mean
802113|NCT00980005|Secondary|Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains.|"The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.
Seroconversion factor (SCF) was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination.
Seroconversion factor (SCF) was defined as the geometric mean of the within subjects ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. SCFs were calculated at Day 28 following the complete vaccination regimen."|At Day 0 and at Day 28 after last vaccine dose|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination.||Fold increase||95% Confidence Interval|Mean
802114|NCT00980005|Secondary|Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata.|"The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.
Seroprotection rate (SPR) was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 that represents a putative protective level in adults.
Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years."|At Day 0 and 28 after last vaccine dose.|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination.||Subjects|||Number
802131|NCT00980174|Primary|Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12||From Baseline to 12 Months|Subjects with baseline and at least one post baseline measurements||Percent||95% Confidence Interval|Mean
802115|NCT00980005|Secondary|Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains.|"The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.
Seroprotection rate (SPR) was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 that represents a putative protective level in adults."|At Day 0 and 28 after last vaccine dose.|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination.||Subjects|||Number
802116|NCT00980005|Secondary|Number of Seroconverted Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata.|"The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.
Seroconversion was defined as the percentage of vaccinees that had either a pre-vaccination (Day 0) titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer.
Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years."|At Day 28 after last vaccine dose.|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination.||Subjects|||Number
802117|NCT00980005|Secondary|Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata.|"The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.
Titers were expressed as geometric mean antibody titers (GMTs).
Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years."|At Day 0 and 28 after last vaccine dose.|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination.||Titers||95% Confidence Interval|Geometric Mean
802118|NCT00980005|Primary|Number of Seroconverted Subjects for HI Antibodies Against the Three Strains.|"The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.
Seroconversion was defined as the percentage of vaccinees that had either a pre-vaccination (Day 0) titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer."|At Day 28 after last vaccine dose.|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination.||Subjects|||Number
802119|NCT00980005|Primary|Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains.|"The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.
Titers were expressed as geometric mean antibody titers (GMTs)."|At Day 0 and 28 after last vaccine dose.|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination.||Titers||95% Confidence Interval|Geometric Mean
802120|NCT00980044|Primary|Total Number of Breakthrough Withdrawal Medication Doses Taken Week 2|There were four medications (acetaminophen for aches/pains, zolpidem for trouble sleeping, bismuth subsalicylate for diarrhea, and alumina/magnesia/simethicone for nausea/upset stomach) available to all volunteers in all treatment arms to help relieve any withdrawal symptoms that were not relieved by the blinded tramadol/placebo doses.|Days 8-13 (all groups now on placebo)|The primary analysis was ANOVA with day and treatment arm as factors. The outcome measure described below is the mean number of doses/day across the days listed.||mean # of doses per day||Standard Error|Mean
802121|NCT00980044|Primary|Subjective Opioid Withdrawal Adjective Total Score Week 2|range of scores is 0-84; low scores indicate no opioid withdrawal, higher scores indicating more opioid withdrawal present|days 8-13|The primary analysis was ANOVA with day and treatment arm as factors. The outcome measure described below is the mean total withdrawal score across the days listed.||units on a scale||Standard Error|Mean
802122|NCT00980044|Primary|Total Number of Breakthrough Withdrawal Medication Doses Taken Week 1|There were four medications (acetaminophen for aches/pains, zolpidem for trouble sleeping, bismuth subsalicylate for diarrhea, and alumina/magnesia/simethicone for nausea/upset stomach) available to all volunteers in all treatment arms to help relieve any withdrawal symptoms that were not relieved by the blinded tramadol/placebo doses.|Days 1-7|These are data from week 1 -- the 12 people who completed this week in each group. This is the analysis that was specified at the start of the study. The primary analysis was ANOVA with day and treatment arm as factors. The outcome measure described below is the mean across the days listed.||Mean doses per day||Standard Error|Mean
802123|NCT00980044|Primary|Subjective Opioid Withdrawal Total Adjective Score|range of scores is 0-84; low scores indicate no opioid withdrawal, higher scores indicating more opioid withdrawal present. T|Days 1-7|The primary analysis was ANOVA with day and treatment arm as factors. The outcome measure described below is the mean across the days listed.||units on a scale||Standard Error|Mean
802124|NCT00980148|Secondary|Demographical Characteristics and Clinical Parameters to Predict Treatment Outcome.||Baseline and study visit #2 (Day 28 after therapy is started)||||||
802125|NCT00980148|Primary|Assess Microbiological Failure of Recommended Azithromycin and Doxycycline Regimens in Uncomplicated Chlamydia Trachomatis Infection in a Setting Where Repeat Exposure to Chlamydia-infected Persons Can be Minimized.|The proportion of participants with testing by Gen-Probe Aptima Combo 2 that is positive for C. trachomatis and C. trachomatis OmpA (Major Outer Membrane Protein) genotyping reveals the baseline chlamydial strain and the repeat positive chlamydial strain to be the same genotype (i.e., concordant).|Study visit # 2 (Day 28 after therapy started)|The per protocol population is comprised of participants who completed therapy and whose failure status could be established at the day 28 visit. Participants were considered to have completed therapy if they took a single dose of azithromycin or at least 10 of the 14 doses of doxycycline.||percentage of participants|||Number
802126|NCT00980174|Secondary|Serum Type 1 Collagen C-telopeptide (CTX) Percent Change From Baseline at Day 15||From Baseline to Day 15|||Percent||Inter-Quartile Range|Median
802127|NCT00980174|Secondary|Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 12||From Baseline to 12 Months|||Percent||95% Confidence Interval|Mean
802132|NCT00980200|Secondary|Change From Baseline in Weighted Mean 24-hour FEV1 on Day 7 of the Treatment Period|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Weighted mean was derived by calculating the average area under curve, and then dividing by the relevant time interval. 24-hour serial measurements of FEV1 were performed on Day 7 of each of the 5 treatment periods (Visits 3, 5, 7, 9, and 11). Measurements were taken at pre-dose; 30 and 60 minutes; and 3, 5, 11, 12, 12.5, 13, 15, 17, 23, and 24 hours post-dose. Visits 3, 5, 7, 9, and 11 were overnight visits. Change from Baseline was calculated as the Day 7 value minus the Baseline value. Analysis was performed using a mixed effects analysis of covariance (ANCOVA) model, with fixed effects for treatment, period, sex, and age. Participant was fitted as a random effect, and the period Baseline FEV1 measurement was included as part of a bivariate response. The model for the period Baseline value is not affected by treatment group.|Baseline and Day 7 of the treatment period (up to Study Day 63)|ITT Population. Only those participants available at the indicated time points were analyzed.||Liters||Standard Error|Least Squares Mean
802133|NCT00980200|Primary|Change From Baseline in Trough (Pre-bronchodilator and Pre-dose) FEV1 on Day 7 of the Treatment Period|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is defined as the mean of the FEV1 values obtained at the last two scheduled time points at the Day 7 clinic visit (i.e., 11 and 12 hours after the morning dose, or 23 and 24 hours after the evening dose). Change from Baseline was calculated as the Day 7 value minus the Baseline value. Analysis was performed using a mixed model analysis of covariance (ANCOVA) with fixed effects of treatment, period, sex, and age. Participants is fitted as a random effect, and the period Baseline measurement is included as part of a bivariate response. The model for the period Baseline value is not affected by treatment group.|Baseline and Day 7 of the treatment period (up to Study Day 63)|Intent-to Treat (ITT) Population: all participants randomized to treatment who received at least one dose of trial medication. Randomized participants were assumed to have received trial medication unless definitive evidence to the contrary existed. Only participants available at the indicated time point were analyzed.||Liters||Standard Error|Least Squares Mean
802134|NCT00980278|Secondary|Final Bone Volume: Initial Graft Volume Ratio|Bone volume fraction of bone core histological and µCT analyses|4 months|||ratio||Standard Deviation|Mean
802135|NCT00980278|Secondary|Change in Sinus Bone Volume|CBCT was used to evaluated 3-D changes in the bone volume within the treated areas of the sinus cavity|Pre-baseline and within 2 weeks of 4 Month visit|||cm3||Standard Deviation|Mean
802136|NCT00980278|Primary|Bone Volume Fraction of Bone Core|Bone volume fraction of bone core histological and µCT analyses|4 months|||ratio||Standard Deviation|Mean
802137|NCT00980278|Secondary|Change in Linear Radiographic Bone Height|Change in linear radiographic bone heights were measured before and after bone graft reconstruction|Screening and 1 week post-op from baseline|||mm||Standard Deviation|Mean
802138|NCT00980278|Primary|Bone Mineral Density of Bone Core|Bone mineral density of bone core was measured by histological and µCT analyses|4 months|||mg/mm^3||Standard Deviation|Mean
802139|NCT00980330|Secondary|Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24h) for TMC435|The table below shows the median (range) AUC24h values for TMC435 for participants in each TMC435 treatment group.|0 (predose, baseline) and 4, 8, 12, and 24 hours post-dose at Weeks 2, 4, 8, 12, 16, 24, and 48|Participants who received at least 1 dose of study medication with at least 1 post-baseline pharmacokinetic (PK) assessment were included in the PK analysis population.||ng.h/mL||Full Range|Median
802140|NCT00980330|Secondary|Plasma Concentrations of TMC435|The table below shows median (range) predose plasma concentration (C0h) values and median (range) average steady-state plasma concentration (Css,av) values for TMC435 for participants in each of the 6 TMC435 treatment groups.|0 (predose, baseline) and 4, 8, 12, and 24 hours post-dose at Weeks 2, 4, 8, 12, 16, 24, and 48|Participants who received at least 1 dose of study medication with at least 1 post-baseline pharmacokinetic (PK) assessment were included in the PK analysis population.||ng/mL||Full Range|Median
802141|NCT00980330|Secondary|The Number of Participants Who Achieved Normalized Alanine Aminotransferase (ALT) Levels at the End of Treatment (EOT)|The table below shows the number of participants with abnormal ALT levels at Baseline who achieved the normal ALT levels at the EOT (up to Week 48).|EOT (up to Week 48)|Intent-to-treat: Participants who received at least 1 dose of study medication were included.||Percentage of participants|||Number
802142|NCT00980330|Secondary|The Percentage of Participants With Viral Relapse|The table below shows the percentage of participants in the overall population who had viral relapse, defined as confirmed detectable Hepatitis C virus (HCV) ribonucleic acid (RNA) during the follow-up period in participants with HCV RNA less than 25 IU/mL undetectable at end of treatment.|Up to Week 72|Intent-to-treat: Participants who received at least 1 dose of study medication were included.||Percentage of participants|||Number
802143|NCT00980330|Secondary|The Percentage of Participants With Viral Breakthrough|The table below shows the percentage of participants in the overall population in each treatment group during the treatment period who experienced viral breakthrough, defined as a confirmed increase of greater than 1 log10 IU/mL in Hepatitis C virus (HCV) ribonucleic acid (RNA) from the lowest level reached or a confirmed HCV RNA of > 100 IU/mL in participants whose HCV RNA had previously been below the lower limit of quantification (i.e., less than 25 IU/mL detectable or undetectable).|EOT (up to Week 48)|Intent-to-treat: Participants who received at least 1 dose of study medication were included.||Percentage of participants|||Number
802144|NCT00980330|Secondary|The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12)|The table below shows the percentage of participants in the overall population who achieved undetectable plasma Hepatitis C virus ribonucleic acid levels at the end of treatment (EOT) and 12 Weeks after the planned EOT.|Week 60|Intent-to-treat: Participants who received at least 1 dose of study medication were included.||Percentage of participants|||Number
802145|NCT00980330|Secondary|The Percentage of Participants Achieving a Complete Early Virologic Response (cEVR)|The table below shows the percentage of participants in each treatment group who had a cEVR, defined as having undetectable plasma levels of Hepatitis C virus ribonucleic acid at Week 12.|Week 12|Intent-to-treat: Participants who received at least 1 dose of study medication were included.||Percentage of participants|||Number
802163|NCT00980642|Secondary|Specificity for Detection of Hypothermia|Hypothermia will be defined as a temperature < 36 Celsius degree|From anesthesia induction to the end of surgery|||percent of non-hypothermias||95% Confidence Interval|Number
802146|NCT00980330|Secondary|The Percentage of Participants Achieving an Early Virologic Response (EVR)|The table below shows the percentage of participants who achieved an EVR, defined as having a greater than or equal to 2 log10 reduction in plasma Hepatitis C virus ribonucleic acid from baseline at Week 12.|Week 12|Intent-to-treat: Participants who received at least 1 dose of study medication were included.||Percentage of participants|||Number
802147|NCT00980330|Secondary|The Percentage of Participants Achieving a Rapid Virologic Response (RVR)|The table below shows the percentage of participants in each treatment group who achieved a RVR, defined as having an undetectable plasma Hepatitis C virus ribonucleic acid level after receiving 4 weeks of treatment.|Week 4|Intent-to-treat: Participants who received at least 1 dose of study medication were included.||Percentage of participants|||Number
802148|NCT00980330|Secondary|The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-up|The table below shows the percentage of participants in each treatment group who achieved plasma HCV RNA levels below the limit of quantification defined as less than 25 IU/mL (detectable or undetectable) at selected time points during treatment, follow-up, and at the end of treatment (EOT).|Weeks, 2, 4, 8, 12, 24, 36, 48, 60, 72, and EOT (up to Week 48)|Intent-to-treat: Participants who received at least 1 dose of study medication were included.||Percentage of Participants|||Number
802149|NCT00980330|Secondary|The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-up|The table below shows the percentage of participants in each treatment who achieved plasma HCV RNA levels of <25 IU/mL undetectable at selected time points during treatment and follow-up and at the end of treatment (EOT).|Weeks, 2, 4, 8, 12, 24, 36, 48, 60, 72 and EOT (up to Week 48)|Intent-to-treat: Participants who received at least 1 dose of study medication were included.||Percentage of participants|||Number
802150|NCT00980330|Secondary|The Percentage of Participants With a Greater Than 2 log10 Drop in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Time Points During Treatment|The table below shows the percentage of participants in each treatment group who achieved a greater than 2 log10 drop in plasma levels of HCV RNA at selected time points during treatment.|Weeks, 2, 4, 8, and 12|Intent-to-treat: Participants who received at least 1 dose of study medication were included.||Percentage of participants|||Number
802151|NCT00980330|Primary|The Percentage of Participants Achieving a Sustained Virologic Response at the End of Treatment (EOT) and 24 Weeks After the EOT (SVR24)|The table below shows the percentage of participants in the overall population with an SVR24, defined as having plasma levels of Hepatitis C Virus ribonucleic acid less than 25 IU/mL undetectable at the EOT and 24 weeks after the EOT.|Week 72|Intent-to-treat: Participants who received at least 1 dose of study medication were included.||Percentage of participants|||Number
802152|NCT00980343|Secondary|Determine Drug Effect (Pharmacokinetics) in Plasma for Arm 1|samples collected pre tumor resection (day of surgery) and post-tumor resection (day of surgery|Day of surgery|||ng/ml||Standard Deviation|Median
802153|NCT00980343|Secondary|Changes in Sonic Hedgehog Pathway Activation|determined by Reverse transcription polymerase chain reaction (RT-PCR) and immunohistochemistry (IHC) (Gli-1, Gli-2, PATCH (PTCH-1b)|Pre-tumor resection and post tumor resection (12 hours)|only small number of samples and thus not enough to give useful information. Samples not processed for outcome and analysis was not performed. No numerical data to report|||||
802154|NCT00980343|Secondary|Incidence of CD133+ Neurospheres by Arm|number of tumor-derived CD133 neurospheres undergoing proliferation and self-renewal|12 hours post-vismodegib administration|||percent of CD133 Neuospheres|||Number
802155|NCT00980343|Secondary|Toxicity Incidence Grade 3 or 4 According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0|NCI CTCAE grade 3 or 4 possible, probable or definitely related events Grade 3 - severe Grade 4 - life threatening|30 days from last dose of drug treatment - 1.5 years|||percent of participants|||Number
802156|NCT00980343|Secondary|Best Tumor Response Assessed by the Modified Macdonald Radiographic Response Criteria|"The Macdonald criteria, roughly similarly to other systems, divides response into 4 types of response based on imaging (MRI) and clinical features
1: complete response; 2: partial response; 3:stable disease; 4:progression
Complete response imaging features: disappearance of all enhancing disease (measurable and non-measurable) sustained for at least 4 weeks; no new lesions clinical features; no corticosteroids; clinically stable or improved
Partial response imaging features: 50% or more decrease of all measurable enhancing lesions sustained for at least 4 weeks: no new lesions clinical features: stable or reduced corticosteroids; clinically stable or improved
Stable disease imaging features: does not qualify for complete response, partial response or progression clinical features: clinically stable
Progression imaging features: 25% of more increase in enhancing lesions; any new lesions clinical features: clinical deterioration"|evaluated every 8 weeks - 1 year|3 subjects not evaluable for radiographic response Arm 1 and 4 subjects not evaluable for radiographic response in Arm 2||participants|||Number
802157|NCT00980343|Secondary|Overall Survival Time|The overall failure rate will be estimated along with 95% confidence intervals. A median time of survival will be estimated using standard methods.. Start date based on onset of treatment.|3 years|||months||95% Confidence Interval|Median
802158|NCT00980343|Primary|6 Months Progression-free Survival (PFS)|Estimated using Kaplan Meier curves. six months calculated from date of treatment onset post-operatively. MRI scan at 6 months must be free of progression Progressive disease Progressive neurological abnormalities not explained by other causes or greater than 25% increase in size of tumor or if new lesion.|6 months|||percentage of patients||95% Confidence Interval|Number
802159|NCT00980590|Secondary|Incidence of Intubation Complications|Including mucosal trauma, dental injury, lip injury, hypoxia (SPO2<95%) and Esophageal intubation|Intubation period|||cases|||Number
802160|NCT00980590|Secondary|Number of Intubation Attempts||Intubation period|||times|||Number
802161|NCT00980590|Secondary|Overall Intubation Success Rate||Intubation period|||Percentage of overall intubation|||Number
802162|NCT00980590|Primary|Intubation Time|For the case with number of intubation attempt no more than 3, intubation time was defined as the total time of individual intubation attempt. Otherwise, intubation was defined as a failure and excluded from the calculation of intubation time.|The time from picking up the Airway Scope or Macintosh laryngoscope to confirmation of tracheal intubation by capnography.|Patients with number of intubation attempt no more than 3||seconds||Standard Deviation|Mean
802273|NCT00974051|Secondary|Percent of Nighttime Glucose Levels <80||9:00pm to 6:00am|||percentage of overnight glucose levels|||Number
802165|NCT00980642|Primary|The Bias Between Temperature Measured by Drager Double-sensor vs Core Temperature|Determine if the Drager double-sensor temperature monitoring system, used at the forehead is accurate compared to esophageal temperature for general anesthesia group and bladder temperature for regional anesthesia group.|From anesthesia induction to the end of surgery|||Celsius degree||95% Confidence Interval|Mean
802166|NCT00980655|Other Pre-specified|Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4|Specific systemic events (fever >=38 degrees Celsius [C], fatigue, headache, vomiting, diarrhea, muscle pain, joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any (symptom present); Mild (did not interfere with activity); Moderate (some interference with activity); Severe (prevented routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours); Moderate (>2 times in 24 hours); Severe (required intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hours); Moderate (4-5 loose stools 24 hours); Severe (>=6 loose stools in 24 hours).|Within 14 days after 13vPnC Dose 4|Safety population. Here 'N' (number of participants analyzed) signifies participants with known values for any systemic event and 'n' signifies participants with known values for specified systemic event. Participants may be represented in more than 1 category.||percentage of participants||95% Confidence Interval|Number
802167|NCT00980655|Other Pre-specified|Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 3|Specific systemic events (fever >=38 degrees Celsius [C], fatigue, headache, vomiting, diarrhea, muscle pain, joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any (symptom present); Mild (did not interfere with activity); Moderate (some interference with activity); Severe (prevented routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours); Moderate (>2 times in 24 hours); Severe (required intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hours); Moderate (4-5 loose stools 24 hours); Severe (>=6 loose stools in 24 hours).|Within 14 days after 13vPnC Dose 3|Safety population. Here 'N' (number of participants analyzed) signifies participants with known values for any systemic event and 'n' signifies participants with known values for specified systemic event. Participants may be represented in more than 1 category.||percentage of participants||95% Confidence Interval|Number
802168|NCT00980655|Other Pre-specified|Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 2|Specific systemic events (fever >=38 degrees Celsius [C], fatigue, headache, vomiting, diarrhea, muscle pain, joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any (symptom present); Mild (did not interfere with activity); Moderate (some interference with activity); Severe (prevented routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours); Moderate (>2 times in 24 hours); Severe (required intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hours); Moderate (4-5 loose stools 24 hours); Severe (>=6 loose stools in 24 hours).|Within 14 days after 13vPnC Dose 2|Safety population. Here 'N' (number of participants analyzed) signifies participants with known values for any systemic event and 'n' signifies participants with known values for specified systemic event. Participants may be represented in more than 1 category.||percentage of participants||95% Confidence Interval|Number
802169|NCT00980655|Other Pre-specified|Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 1|Specific systemic events (fever >=38 degrees Celsius [C], fatigue, headache, vomiting, diarrhea, muscle pain, joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any (symptom present); Mild (did not interfere with activity); Moderate (some interference with activity); Severe (prevented routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours); Moderate (>2 times in 24 hours); Severe (required intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hours); Moderate (4-5 loose stools 24 hours); Severe (>=6 loose stools in 24 hours).|Within 14 days after 13vPnC Dose 1|Safety population. Here 'N' (number of participants analyzed) signifies participants with known values for any systemic event and 'n' signifies participants with known values for specified systemic event. Participants may be represented in more than 1 category.||percentage of participants||95% Confidence Interval|Number
802170|NCT00980655|Other Pre-specified|Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 4|Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as Any (redness present or swelling present); Mild (0.5 to 2.0 centimeters [cm] for participants aged 2 to <12 years and 2.5 to 5.0 cm for participants aged >= 12 years); Moderate (2.5 to 7.0 cm for participants aged 2 to <12 years and 5.5 to 10.0 cm for participants aged >= 12 years); Severe (greater than [>] 7.0 cm for participants aged 2 to <12 years and >10.0 cm for participants aged >= 12 years). Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity).|Within 14 days after 13vPnC Dose 4|Safety population. Here 'N' (number of participants analyzed) signifies participants with known values for any local reaction and 'n' signifies participants with known values for specified local reaction. Participants may be represented in more than 1 category.||percentage of participants||95% Confidence Interval|Number
802171|NCT00980655|Other Pre-specified|Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 3|Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as Any (redness present or swelling present); Mild (0.5 to 2.0 centimeters [cm] for participants aged 2 to <12 years and 2.5 to 5.0 cm for participants aged >= 12 years); Moderate (2.5 to 7.0 cm for participants aged 2 to <12 years and 5.5 to 10.0 cm for participants aged >= 12 years); Severe (greater than [>] 7.0 cm for participants aged 2 to <12 years and >10.0 cm for participants aged >= 12 years). Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity).|Within 14 days after 13vPnC Dose 3|Safety population. Here 'N' (number of participants analyzed) signifies participants with known values for any local reaction and 'n' signifies participants with known values for specified local reaction. Participants may be represented in more than 1 category.||percentage of participants||95% Confidence Interval|Number
802172|NCT00980655|Other Pre-specified|Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 2|Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as Any (redness present or swelling present); Mild (0.5 to 2.0 centimeters [cm] for participants aged 2 to <12 years and 2.5 to 5.0 cm for participants aged >= 12 years); Moderate (2.5 to 7.0 cm for participants aged 2 to <12 years and 5.5 to 10.0 cm for participants aged >= 12 years); Severe (greater than [>] 7.0 cm for participants aged 2 to <12 years and >10.0 cm for participants aged >= 12 years). Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity).|Within 14 days after 13vPnC Dose 2|Safety population. Here 'N' (number of participants analyzed) signifies participants with known values for any local reaction and 'n' signifies participants with known values for specified local reaction. Participants may be represented in more than 1 category.||percentage of participants||95% Confidence Interval|Number
802173|NCT00980655|Other Pre-specified|Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 1|Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as Any (redness present or swelling present); Mild (0.5 to 2.0 centimeters [cm] for participants aged 2 to <12 years and 2.5 to 5.0 cm for participants aged >= 12 years); Moderate (2.5 to 7.0 cm for participants aged 2 to <12 years and 5.5 to 10.0 cm for participants aged >= 12 years); Severe (greater than [>] 7.0 cm for participants aged 2 to <12 years and >10.0 cm for participants aged >= 12 years). Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity).|Within 14 days after 13vPnC Dose 1|Safety population. Here 'N' (number of participants analyzed) signifies participants with known values for any local reaction and 'n' signifies participants with known values for specified local reaction. Participants may be represented in more than 1 category.||percentage of participants||95% Confidence Interval|Number
802174|NCT00980655|Secondary|Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 3 to 1 month after 13vPnC Dose 4 were computed using the logarithmically transformed assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both after 13vPnC Dose 3 and after 13vPnC Dose 4 blood draws.|1 month after 13vPnC Dose 3, 1 month after 13vPnC Dose 4|Evaluable immunogenicity population. Here 'N' (number of participants analyzed) signifies all participants who were evaluable for this measure and 'n' signifies all participants who were evaluable for specified serotype for each treatment arm, respectively.||fold rise||95% Confidence Interval|Geometric Mean
802175|NCT00980655|Secondary|Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC Dose 1 to 1 month after 13vPnC Dose 4 were computed using the logarithmically transformed assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both before 13vPnC Dose 1 and after 13vPnC Dose 4 blood draws.|Before 13vPnC Dose 1 (pre-vaccination), 1 month after 13vPnC Dose 4|Evaluable immunogenicity population. Here 'N' (number of participants analyzed) signifies all participants who were evaluable for this measure and 'n' signifies all participants who were evaluable for specified serotype for each treatment arm, respectively.||fold rise||95% Confidence Interval|Geometric Mean
802176|NCT00980655|Secondary|Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC Dose 1 to 1 month after 13vPnC Dose 3 were computed using the logarithmically transformed assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both before 13vPnC Dose 1 and after 13vPnC Dose 3 blood draws.|Before 13vPnC Dose 1 (pre-vaccination), 1 month after 13vPnC Dose 3|Evaluable immunogenicity population. Here 'N' (number of participants analyzed) signifies all participants who were evaluable for this measure and 'n' signifies all participants who were evaluable for specified serotype for each treatment arm, respectively.||fold rise||95% Confidence Interval|Geometric Mean
802177|NCT00980655|Secondary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants|Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for pediatric, adult and all participants are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for 1 month after 13vPnC Dose 4 blood draw. CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|1 month after 13vPnC Dose 4|Evaluable immunogenicity population. Here 'N' (number of participants analyzed) signifies all participants who were evaluable for this measure and 'n' signifies all participants who were evaluable for specified serotype for each treatment arm, respectively.||mcg/mL||95% Confidence Interval|Geometric Mean
802178|NCT00980655|Secondary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants|Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for pediatric, adult and all participants are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated. Geometric means were calculated using all participants with available data for 1 month after 13vPnC Dose 3 blood draw. CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|1 month after 13vPnC Dose 3|Evaluable immunogenicity population. Here 'N' (number of participants analyzed) signifies all participants who were evaluable for this measure and 'n' signifies all participants who were evaluable for specified serotype for each treatment arm, respectively.||microgram per milliliter (mcg/mL)||95% Confidence Interval|Geometric Mean
802179|NCT00980655|Primary|Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 3 in All Participants|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC Dose 1 to 1 month after 13vPnC Dose 3 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both before 13vPnC Dose 1 and after 13vPnC Dose 3 blood draws.|Before 13vPnC Dose 1 (pre-vaccination), 1 month after 13vPnC Dose 3|Evaluable immunogenicity population:eligible participants who received vaccination as assigned;had blood drawn within pre-specified time-frames;had at least 1 valid, determinate assay result; had no major protocol violation. N (number of participants analyzed)=participants evaluable for this measure, n=participants evaluable for specified serotype.||fold rise||95% Confidence Interval|Geometric Mean
802180|NCT00980681|Primary|Percent of Non Assessable Renal Artery Segments|For each examination (TOF and Dotarem-enhanced MRA) the percent of non-assessable segments will be compared|1 to 7 days|||percentage of non-assessable segments|||Number
802181|NCT00980746|Primary|Change From Baseline to Endpoint in Mean Pain, Scored Daily on a on an 11-point (0-10) Numeric Rating Pain Scale (NRPS), Where 0 = no Pain and 10 = Worst Possible Pain|﻿Endpoint mean pain was defined as the mean of the last 4 available pain scores in the last 7 days of the treatment period. Likewise, baseline mean pain was defined as the mean of the last 4 available pain scores in the last 7 days of the baseline period.|17 weeks|||units on a scale||Standard Error|Least Squares Mean
802182|NCT00980798|Secondary|The Number of Patients Discontinuing From the Trial Due to the Occurrence of an Adverse Event|The number of patients dropping out of the study owing to adverse events will be presented for each treatment group.|At each study visit from baseline until week 16|Safety population: All randomised patients who received at least one dose of study drug.||participants|||Number
802183|NCT00980798|Primary|Analgesic Effect as Assessed by Brief Pain Inventory (BPI) Item 5 Score (Pain on Average)|"The analgesic effect was assessed by the BPI item 5 “pain on average” using a 0 to 10 numeric rating scale, with 0 being no pain and 10 being pain as bad as you can imagine."|At each study visit from screening to week 16|The primary population for the efficacy analyses was the intention to treat (ITT) population: all randomised patients who received at least one dose of study drug excluding patients who had no post-baseline efficacy data. This population included patients who discontinued early owing to lack of efficacy or other reasons.||units on a scale||Standard Deviation|Mean
802184|NCT00980980|Secondary|Intervention Impact on Chlorhexidine Susceptibility of MRSA Isolates|Frequency of MRSA+ isolates from ICU patients with reduced susceptibility to chlorhexidine (CHG) (MIC >4 μg/ml), comparing baseline to intervention period across arms, accounting for clustering by hospital.|25-month time frame represents 7-month baseline and 18-month intervention periods|The total number of participants analyzed reflects the combined total of baseline and intervention participants during the outcome time frame, for each arm. The total number of units analyzed reflects the combined total of MRSA+ isolates collected from ICU patients during baseline and intervention phase, for each arm.||MRSA isolates non-susceptible to CHG|MRSA+ isolates||Number
802185|NCT00980980|Secondary|Intervention Impact on Mupirocin Susceptibility of MRSA Isolates|Odds ratio for MRSA+ isolates from ICU patients expressing low-level mupirocin resistance (LLMR) and high-level mupirocin resistance (HLMR), comparing baseline to intervention period across arms, accounting for clustering by hospital.|25-month time frame represents 7-month baseline and 18-month intervention periods|The total number of participants analyzed reflects the combined total of baseline and intervention participants during the outcome time frame, for each arm. The total number of units analyzed reflects the combined total of MRSA+ isolates collected from ICU patients during baseline and intervention phase, for each arm.||Odds Ratio|MRSA+ isolates|95% Confidence Interval|Number
802186|NCT00980980|Secondary|Intervention Impact on Bacteriuria and Candiduria|Proportional hazard ratio for as-randomized, unadjusted, ICU-attributable bacteriuria, comparing Baseline to Intervention period across Arms, accounting for clustering by hospital. High-level bacteriuria is defined as ≥50,000 CFU/mL, high-level candiduria is defined as ≥50,000 CFU/mL.|30-month time frame represents 12-month baseline and 18-month intervention periods.|The number of participants analyzed reflects the combined total of baseline and intervention admissions with an ICU stay, for each arm.||Hazard Ratio||95% Confidence Interval|Number
802187|NCT00980980|Secondary|Blood Culture Contamination Rates|Odds ratio for ICU-attributable blood culture contamination rates, comparing Baseline to Intervention period across Arms, accounting for clustering by hospital.|24-month time frame for this analysis represents a 6-month baseline and 18-month intervention period.|The number of participants analyzed reflects the combined total of baseline and intervention admissions, with an ICU stay and a blood draw set, for each arm.||Odds Ratio||95% Confidence Interval|Number
802188|NCT00980980|Secondary|Intervention Impact on Healthcare Costs|Costs (in dollars) per 1000 ICU-admissions associated with 3 ICU strategies to reduce ICU Bloodstream infection (BSI), (Arms 1-3).|12-month period|Annual adult ICU admissions per hospital, over the course of 1 year.||Dollars per 1000 ICU-admissions|||Number
802189|NCT00980980|Secondary|ICU-attributable All-pathogen Bloodstream Infection|Hazard ratio for ICU-attributable positive blood culture from any pathogen, comparing Baseline to Intervention period, by Arm, accounting for clustering by hospital.|The 30-month time frame represents 12-month baseline and 18-month intervention periods. During these time periods, outcomes are defined as events occurring during attributed ICU time: from day 3 of the ICU stay until 2 days after ICU discharge.|The total number of participants analyzed included the table reflects the combined total of baseline and intervention participants, for each arm.||Hazard ratio||95% Confidence Interval|Number
802190|NCT00980980|Secondary|MRSA Bloodstream Infection|Hazard ratio for ICU-attributable MRSA+ blood cultures comparing Baseline to Intervention period, by Arm, accounting for clustering by hospital.|The 30-month time frame represents 12-month baseline and 18-month intervention periods. During these time periods, outcomes are defined as events occurring during attributed ICU time: from day 3 of the ICU stay until 2 days after ICU discharge.|The total number of participants analyzed included the table reflects the combined total of baseline and intervention participants, for each arm.||hazard ratio||95% Confidence Interval|Number
805551|NCT01004393|Secondary|Constipation Assessment (Severity and Distress) After Administration of Subcutaneous Methylnaltrexone||48 hours after the dose of subcutaneous methylnaltrexone|||percentage of participants||95% Confidence Interval|Number
802191|NCT00980980|Primary|Main Outcome: Patients With Nosocomial MRSA Clinical Cultures|Hazard ratio for ICU-attributable MRSA+ clinical cultures comparing Baseline to Intervention period, by Arm, accounting for clustering by hospital.|The 30-month time frame represents 12-month baseline and 18-month intervention periods. During these time periods, outcomes are defined as events occurring during attributed ICU time: from day 3 of the ICU stay until 2 days after ICU discharge.|The total number of participants analyzed included the table reflects the combined total of baseline and intervention participants, for each arm.||hazard ratio||95% Confidence Interval|Number
802192|NCT00981019|Secondary|Number of Physicians (= Participants) Assuming a Benefit of Screening|Physicians are faced with four different medical statistics about the effect of screening (e.g., 5-year survival) within four successive scenarios and after each scenario asked whether they assume the screening to be beneficial given the statistical information. Options to answer are: yes, no, can't decide. If yes, then participants are further asked to describe this benefit by the following categories: Very large, large, moderate, small, very small.|25 minutes (mean duration of the survey)||08/2011||||
802193|NCT00981019|Primary|Number of Physicians (=Participants) Recommending the Screening|The aim of the study was to learn how different medical cancer screening statistics would influence doctors' recommendation behavior and their effectiveness judgments of screening tests. For that reason the online survey study presented physicians with four different medical statistics (e.g., 5-year survival) within four successive scenarios and asked after each scenario whether they would recommend the screening to a (hypothetical) patient given the data. Options to answer are: Definitely yes, Probably yes, Probably no, Definitely no, Can’t decide.|25 minutes (mean duration of the survey)|We calculated that a sample size of 300 physicians was needed to have 90% power to detect differences of 20% or higher in the proportion of respondents correctly answering questions about the different cancer statistics (2-sided alpha of .05).||participants|||Number
802194|NCT00981045|Primary|Proportion of Subjects Experiencing at Least One Event in the Primary Composite Safety Endpoint in the Randomized Population.|The primary composite safety endpoint was defined as death due to any cause, nonfatal myocardial infarction, nonfatal stroke, unstable angina requiring hospitalization or medical intervention, arrhythmias, protocol-defined hypersensitive events, and protocol-defined hyposensitive events.|Day 120|||participants|||Number
802195|NCT00981045|Primary|Mean Change From Baseline to the Highest Observed Hemoglobin Any Time From Baseline to End of Study.||Day 56|||g/dL||Standard Deviation|Mean
802196|NCT00981058|Secondary|Number of Participants With a Serum Anti-Necitumumab Antibody Assessment|A participant was considered to have an anti-Necitumumab antibody response if anti-drug antibodies (ADA) were detected at any time point.|Baseline through 31 Months|All randomized participants who received who received at least 1 dose of drug and had evaluable data for antibodies.||participants|||Number
802197|NCT00981058|Secondary|Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab||Day 1 of Cycle 2, 3, 4, 5 and 6 Prior to Necitumumab Drug Infusion, Up to 24 Months|All randomized participants who received at least one dose of study drug and had evaluable data for PK.||micrograms/milliliter (ug/mL)||Geometric Coefficient of Variation|Geometric Mean
802198|NCT00981058|Secondary|Number of Participants With an Epidermal Growth Factor Hormone (EGFR) Protein Expression Measured by Immunohistochemistry (IHC)|EGFR IHC Histoscore H-score = weighted sum of % 1+ cells, twice % 2+ cells, and three times % 3+ cells. IHC H-score criteria was used to assess participants with a low EGFR expression defined by a H-score cutoff value of <200 and participants with a high EGFR expression defined by a H-score of cutoff value of >=200.|31 Months|All randomized participants who received at least one dose of study drug and had evaluable data for EGFR IHC.||participants|||Number
802199|NCT00981058|Secondary|Mean Change From Baseline in PRO Using the Outcomes Lung Cancer Symptom Scale (LCSS)|The LCSS consisted of 9 items: 6 items focused on lung cancer symptoms [loss of appetite, fatigue, cough, dyspnea (shortness of breath), hemoptysis (blood in sputum), and pain] and 3 items were global items (symptom distress, interference with activity level, and global quality of life). Participant responses to each item were measured using visual analogue scales (VAS) with 100-mm lines. A higher score for any item represented a higher level of symptoms/problems. Scores for each of the reported categories ranged from 0 (for best outcome) to 100 (for worst outcome). The Average Symptom Burden Index (ASBI) was the mean of the 6 symptom items of the LCSS, and the Total LCSS was the mean of all 9 LCSS items. ASBI and Total LCSS were not computed for a participant if he/she had 1 or more missing values for the 6 and 9 items, respectively.|Baseline, Cycle 6 (Cycle = 3 Weeks)|All randomized participants who had evaluable data for LCSS.||millimeter (mm)||Standard Deviation|Mean
802200|NCT00981058|Secondary|Mean Change From Baseline in Patient Reported Outcomes (PRO) Using the European Quality of Life-5 Dimension (EQ-5D)|The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a three level scale 1-3 (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension).|Baseline, Cycle 6 (Cycle = 3 Weeks)|All randomized participants who had evaluable baseline and postbaseline EQ-5D data.||units on a scale||Standard Deviation|Mean
802201|NCT00981058|Secondary|Time to Treatment Failure (TTF)|TTF is defined as the time from the date of randomization until the date of the first radiographic documentation of PD, death from any cause, discontinuation of treatment for any reason, or initiation of new cancer therapy. Participants who withdrew from the study for reasons other than progression or death were censored at the date of study withdrawal. Participants who did not meet any of the criteria for treatment failure were censored at their date of last contact in the study.|Randomization to Measured Progressive Disease, Death From Any Cause, Discontinuation of Treatment or Initiation of New Anticancer Therapy (Up to 31 Months)|All randomized participants. Censored participants: Necitumumab + Gemcitabine + Cisplatin = 16, Gemcitabine + Cisplatin =20||Months||95% Confidence Interval|Median
802214|NCT00981175|Primary|Number of Participants With Seroconversion to Homologous ChimeriVax-JE Virus Strain After a Single Dose of Chimerivax™-JE and Placebo Dose|Assay by 50% Plaque Reduction Neutralization Test (PRNT50) Seroconversion: PRNT50 ≥ 10 and PRNT50 ≥ 20. Assessed in all participants who received ChimeriVax™-JE vaccine on Day 0 and Day 28.|Day 28 post-vaccination|Immunogenicity was assessed in the Intent-to-Treat Population.||Participants|||Number
802202|NCT00981058|Secondary|Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR) (Objective Response Rate [ORR])|ORR is confirmed best overall tumor response of CR or PR. According to RECIST v1.0, CR was defined as the disappearance of all target and non-target lesions. PR defined as a >=30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD; Percentage of participants was calculated as: (total number of participants with CR or PR from start of the treatment until disease progression or recurrence)/total number of participants treated) * 100.|Baseline to Measured Progressive Disease (Up to 31 Months)|All randomized participants.||percentage of participants||95% Confidence Interval|Number
802203|NCT00981058|Secondary|Progression-Free Survival (PFS)|PFS is defined as the time from randomization until the first radiographic documentation of objective measured progressive disease as defined by RECIST (Version 1.0), or death from any cause. Progressive Disease (PD) was defined as having at least a 20% increase in the sum of the longest diameter of target lesions. Participants who die without a reported prior progression were considered to have progressed on the day of their death. Participants who did not progress or were lost to follow-up were censored at the day of their last radiographic tumor assessment. If no baseline or postbaseline radiologic assessment was available, the participants were censored at the date of randomization. If death or PD occurs after two or more consecutive missing radiographic visits, censoring occurred at the date of the last radiographic visit prior to the missed visits.|Randomization to Measured Progressive Disease or Death from Any Cause (Up to 31 Months)|All randomized participants. Censored participants: Necitumumab + Gemcitabine + Cisplatin = 114, Gemcitabine + Cisplatin = 131||months||95% Confidence Interval|Median
802204|NCT00981058|Primary|Overall Survival Time (OS)|Overall survival is defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive. OS was estimated by the Kaplan-Meier method.|Randomization to Death from Any Cause (Up to 31 Months)|All randomized participants. Censored participants: Necitumumab + Gemcitabine + Cisplatin = 127, Gemcitabine + Cisplatin = 106||Months||95% Confidence Interval|Median
802205|NCT00981084|Primary|Word Generation|Word Generation - Measure of verbal fluency. (Min = 0; No Max. )Higher scores indicate better performance. Scores from derived by subtracting session 2 scores from session 1 scores.|Outcome was assessed after each intervention (2 time points). Time 2 scores were subtracted from time 1 scores.|||number of words generated||Standard Deviation|Mean
802206|NCT00981084|Primary|Stroop|Stroop - Test of impulsivity (min = 0, max = none). Higher scores indicate better performance. Scores from derived by subtracting session 2 scores from session 1 scores.|Outcome was assessed after each intervention (2 time points). Time 2 scores were subtracted from time 1 scores.|||number of colors named||Standard Deviation|Mean
802207|NCT00981084|Primary|CPT -Test of Information Processing Speed|"Lower scores indicate better perforamnce. Scores from derived by subtracting session 2 scores from session 1 scores.
Continuous Performance Test (CPT) - Vigilance and reaction time."|Outcome was assessed after each intervention (2 time points). Time 2 scores were subtracted from time 1 scores.|||milliseconds||Standard Deviation|Mean
802208|NCT00981084|Primary|Learning and Memory Measures.|"Testing was completed after first intervention and again after second intervention.
Higher scores indicate better performance. Scores from derived by subtracting session 2 scores from session 1 scores.
Rey Auditory Verbal Learning Test (RAVLT)- Measure of Verbal Learning (Min = 0; Max = 75).
RAVLT Delay - Measure of Delayed Verbal Recall (Min = 0; Max = 15).
Brief Visuospatial Memory Test (BVMT) Learning - Measure of Visual Learning (Min = 0; Max = 36).
BVMT Delay - Measure of Delayed Visual Recall (Min = 0; Max = 12)."|Outcome was assessed after each intervention (2 time points). Time 2 scores were subtracted from time 1 scores.|||Items recalled||Standard Deviation|Mean
802209|NCT00981175|Secondary|Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment.|Treatment emergent adverse events were assessed in all participants receiving ChimeriVax-JE Vaccine, Diluent (Placebo), or Booster Vaccination.|Day 0 up to 28 post-vaccination|Treatment emergent adverse events were assessed in the Safety Population.||Participants|||Number
802210|NCT00981175|Primary|Number of Participants Reporting Injection Site Treatment Emergent Adverse Events Post-Vaccination With ChimeriVax™-JE or Placebo at Day 0 and Day 28, and Following a Booster of ChimeriVax™-JE at Month 6 in a Subset of the Study Population.|Injection Site Treatment Emergent Adverse Events: Pain, Reaction Not Otherwise Specified (NOS), Erythema, Swelling, Bruising, Nodule, Pigmentation Changes, Pruritus were assessed in all participants for up to 28 days post-Vaccination.|Days 0 to 28 post-vaccination|Injection site reactions were assessed in the Safety Population.||Participants|||Number
802211|NCT00981175|Secondary|Number of Participants With Seroconversion to Homologous ChimeriVax-JE Virus Strain After a Single Dose of Chimerivax™-JE and Placebo Followed or Not by a Booster Vaccine Dose at 6 Month.|Assay by 50% Plaque Reduction Neutralization Test (PRNT50) Seroconversion: PRNT50 ≥ 10 and PRNT50 ≥ 20. Assessed in all participants who received ChimeriVax™-JE vaccine on Day 0 and Day 28 and followed or not by a booster vaccine dose at month 24.|Month 24 post-vaccination|Immunogenicity was assessed in the Intent to Treat Population||Participants|||Number
802212|NCT00981175|Secondary|Number of Participants With Seroconversion to Homologous ChimeriVax™-JE Virus Strain After a Single Dose of Chimerivax™-JE and Placebo Followed or Not by a Booster Vaccine Dose at 6 Month.|Assay by 50% Plaque Reduction Neutralization Test (PRNT50) Seroconversion: PRNT50 ≥ 10 and PRNT50 ≥ 20. Assessed in all participants who received ChimeriVax™-JE vaccine on Day 0 and Day 28 and followed or not by a booster vaccine dose at 6 month.|Month 12 post-vaccination|Immunogenicity was assessed in the Intent to Treat Population||Participants|||Number
802213|NCT00981175|Secondary|Number of Participants With Seroconversion to Homologous ChimeriVax™-JE Virus Strain After a Single Dose of Chimerivax™-JE and Placebo Followed by a Booster Vaccine Dose.|Assay by 50% Plaque Reduction Neutralization Test (PRNT50) Seroconversion: PRNT50 ≥ 10 and PRNT50 ≥ 20. Assessed in all participants who received ChimeriVax™-JE vaccine on Day 0 and Day 28 and pre- and post-Booster vaccination.|Month 6 pre- and post-vaccination|Immunogenicity was assessed in the Intent to Treat Population pre- and post-booster vaccination.||Participants|||Number
802215|NCT00981214|Secondary|Percentage of Stool With Visible Oil or Grease|Mean percentage of oil or grease at each period for total participants was summarized.|Baseline, Day 5 up to Day 11 (dose stabilization period), Day 12 up to Day 18 (treatment period)|Analysis population included all participants who received at least 1 dose of study medication.||percentage of stools||Standard Deviation|Mean
802217|NCT00981214|Secondary|Physician’s and Parent’s or Legal Guardians Assessment of Improvement in Clinical Symptoms|Clinical symptoms of exocrine pancreatic insufficiency (EPI) were assessed by the physician and parent or guardian to determine if the participant showed improvement in symptoms of EPI at end of study after the dose stabilization period. EPI is a syndrome characterized by clinical symptoms of poor absorption of fats, proteins, and to a lesser extent, carbohydrates, which manifests primarily in patients with cystic fibrosis. Number of participants with improvement in clinical symptoms was reported.|Day 19 (end of study)|Analysis population set included all participants who received at least 1 dose of study.||participants|||Number
802218|NCT00981214|Secondary|Mean Number of Pain Symptoms|Symptoms of pain was classified by severity as mild (no impairment of daily activities), moderate (slight impairment of daily activities), or severe (unable to perform daily activities). Mean number of symptoms of specific severity for each participant was calculated from frequency of symptoms by the participant per day. Mean number of symptoms at each period for total participants was summarized.|Baseline, Day 5 up to Day 11 (dose stabilization period), Day 12 up to Day 18 (treatment period)|Analysis population set included all participants who received at least 1 dose of study.||pain symptoms per day||Standard Deviation|Mean
802219|NCT00981214|Secondary|Mean Number of Abdominal Symptoms: Flatulence|Flatulence is presence of excessive gas in the digestive tract. Symptoms of flatulence was classified by severity as mild (no impairment of daily activities), moderate (slight impairment of daily activities), or severe (unable to perform daily activities). Mean number of symptoms of specific severity for each participant was calculated from frequency of symptoms by the participant per day. Mean number of symptoms at each period for total participants was summarized.|Baseline, Day 5 up to Day 11 (dose stabilization period), Day 12 up to Day 18 (treatment period)|Analysis population included all participants who received at least 1 dose of study medication.||flatulences per day||Standard Deviation|Mean
802220|NCT00981214|Secondary|Mean Number of Abdominal Symptoms: Bloating|Bloating is swelling of the intestinal tract caused by excessive gas formation. Symptoms of bloating were classified by severity as mild (no impairment of daily activities), moderate (slight impairment of daily activities), or severe (unable to perform daily activities). Mean number of symptoms of specific severity for each participant was calculated from frequency of symptoms by the participant per day. Mean number of symptoms at each period for total participants was summarized.|Baseline, Day 5 up to Day 11 (dose stabilization period), Day 12 up to Day 18 (treatment period)|Analysis population included all participants who received at least 1 dose of study medication.||bloatings per day||Standard Deviation|Mean
802221|NCT00981214|Secondary|Percentage of Stool Categorized by Consistency|Stool consistency was categorized as hard, formed/normal, soft, watery or overt diarrhea. Percentage of stools of a specific consistency of each participant was calculated as the number of stools with a specific consistency relative to the total number of stools during the collection period. Mean percentage of stool with specific consistency at each period for total participants was summarized.|Baseline, Day 5 up to Day 11 (dose stabilization period) and Day 12 up to Day 18 (treatment period)|Analysis population included all participants who received at least 1 dose of study medication.||percentage of stools||Standard Deviation|Mean
802222|NCT00981214|Primary|Percentage of Participants Who Were Responders After 2 Weeks of Treatment With Study Medication|Responders were defined as those participants without steatorrhea (defined as less than 30% fecal fat content) and without signs and symptoms of malabsorption after 2 weeks of treatment with study medication.|Day 18 (end of treatment)|Analysis population included all participants who received at least 1 dose of study medication.||percentage of participants||95% Confidence Interval|Number
802223|NCT00981214|Secondary|Mean Daily Number of Stools|Mean daily number of stools of each participant was calculated from frequency of stools by the participant per day. Mean daily number of stools at each period for total participants was summarized.|Baseline, Day 5 up to Day 11 (dose stabilization period), Day 12 up to Day 18 (treatment period)|Analysis population included all participants who received at least 1 dose of study medication.||stools per day||Standard Error|Mean
802224|NCT00981214|Secondary|Change From Baseline in Weight at Day 12, 19||Baseline, Day 12, 19|Analysis population included all participants who received at least 1 dose of study medication.||kilogram||Standard Deviation|Mean
802225|NCT00981214|Primary|Percentage of Participants Who Were Responders After 1 Week of Treatment With Study Medication|Responders were defined as those participants without steatorrhea (defined as less than 30 percent (%) fecal fat content) and without signs and symptoms of malabsorption after 1 week of treatment with study medication.|Day 11|Analysis population included all participants who received at least 1 dose of study medication.||percentage of participants||95% Confidence Interval|Number
802226|NCT00981227|Other Pre-specified|Change in Mean Pain (NRPS) From Baseline to Endpoint by Total Daily Dose|Details of neuropathic pain, as recorded in a subject diary, were used for the primary assessment of analgesic efficacy. Subjects assessed their pain using an 11–point (0 “no pain” to 10 “worst possible pain”) NRPS upon awakening each morning and recorded the results in the subject diary. This score reflected the subject’s mean pain over the previous 24 hours. Subjects were trained how to record their pain reliably. Investigators were trained in the subject’s NRPS use during site initiation visits and at the investigators’ meeting.|baseline and 13 weeks|||Points||Standard Error|Least Squares Mean
802227|NCT00981227|Primary|Change in Mean Pain (NRPS) From Baseline to Endpoint in Mean Pain|"The primary efficacy variable will be based upon an 11-point (0-10) Numeric Rating Pain Scale (NRPS), where 0 = no pain and 10 = worst possible pain, to be recorded in a patient's diary upon awakening each morning. This score should reflect the patient's mean pain over the previous 24 hours.
Please note that the change from baseline to endpoint in mean pain, i.e. the difference between endpoint mean pain and baseline mean pain, which are defined as follows:
Baseline mean pain is defined as the mean of the last four available ratings of average daily pain (NRPS) in the patient diary performed in the last 7 days before randomisation.
Endpoint mean pain is defined as the mean of the last four available ratings of average daily pain in the patient diary in the last 7 days of the treatment period."|baseline and 13 weeks|||Points||Standard Error|Least Squares Mean
802228|NCT00981292|Secondary|Number of Participants With Significant Modulation of Mood.|Mood was assessed via computerised visual analogue scales at baseline and post- dose time points. Mood scores were calculated as change from baseline. And significant modulation was determined if baseline scores were significantly different to post dose.|42 minutes|As long as data for all participants was captured for all 3 sessions then that participants data was utilized in the analysis.||Participants|||Number
802229|NCT00981292|Secondary|Number of Participants With Significant Modulation of Cognitive Performance|The cognitive performance of participants was assessed via a range of computerised, mentally demanding, executive function tasks: Serial 3s and 7s subtractions, oddball reaction time task, rapid visual information processing, stroop and simple reaction time.These tasks were completed at baseline and then again 45 minutes after treatment administration. Significant modulation was determined if participants' post dose scores were significantly higher than baseline.|42 minutes|If participants were deemed to have completed the tasks to the best of their ability then their scores were utilized in the analysis.||Participants|||Number
802230|NCT00981292|Primary|Modulation of Levels of Total Haemoglobin|This measure assessed changes in levels of total haemoglobin during the 42 minute post- dose task period. Levels are in μmol/L and represent change from baseline levels.|42 minutes|If NIRS readings were deemed not too affected by artefacts (usually caused by participants moving the headband in some way) then they were utilized in the analysis.||μmol/L||Standard Error|Mean
802231|NCT00981305|Secondary|Change of Vaginal Maturation Index|Vaginal maturation index is a ratio obtained by performing a random cell count of the three major cell types shed from the vaginal squamous epithelium: parabasal, intermediate, and superficial cells. The higher the maturation index, the higher the number of mature cells (those designated superficial and intermediate).|Baseline and 8 weeks|||vaginal maturation index||Standard Deviation|Mean
802232|NCT00981305|Secondary|Change of Vaginal pH||Baseline and 8 weeks|||pH||Standard Deviation|Mean
802233|NCT00981305|Secondary|Change of a Total and Other Five Domains of Female Sexual Function Index Score|The Female Sexual Function Index (FSFI) is a 19-item self-reported instrument used for assessing key dimensions of female sexual function over the past 4 weeks with a total of six domains being analyzed. Each of the six specific domains (desire, arousal, lubrication, orgasm, satisfaction, and pain) analyzed in the FSFI is scored on a scale ranging from 1.2 to 6.0 (desire), 0 to 6.0 (arousal, lubrication, orgasm, and pain) or 0.8 to 6.0 (satisfaction), with higher scores indicating better performance. The total score, falling in a possible range from 2.0 to 36.0, is obtained by adding the six domain scores together.|Baseline and 8 weeks|||units on a scale||Standard Deviation|Mean
802234|NCT00981305|Primary|Change of Pain Score of Female Sexual Function Index|The Female Sexual Function Index (FSFI) is a 19-item self-reported instrument used for assessing key dimensions of female sexual function over the past 4 weeks with a total of six domains being analyzed. Each of the six specific domains (desire, arousal, lubrication, orgasm, satisfaction, and pain) analyzed in the FSFI is scored on a scale ranging from 1.2 to 6.0 (desire), 0 to 6.0 (arousal, lubrication, orgasm, and pain) or 0.8 to 6.0 (satisfaction), with higher scores indicating better performance. The total score, falling in a possible range from 2.0 to 36.0, is obtained by adding the six domain scores together.|Baseline and 8 weeks|||units on a scale||Standard Deviation|Mean
802235|NCT00981370|Primary|To Determine if Red Cell Survival as Assessed by Hemoglobin Level, Reticulocyte Count, Lactic Acid Dehydrogenase, and Plasma Hemoglobin in Sickle Cell Patients is Related to the Degree of Iron Overload||Baseline, 6 months and 12 months||||||
802236|NCT00981409|Secondary|The Percentage of Participants With a Bleeding Event|Bleeding events (major bleeding [clinically overt bleeding with: fatality, location in critical organ, a fall in hemoglobin >=2 g/dL, or a transfusion >=2 units], minor bleeding [clinically overt bleeding and not adjudicated as major bleeding]) were adjudicated blindly by the Central Independent Adjudication Committee of Safety (CIACS).|FPX or UFH treatment period (Days 5-10, on average)|Safety population: all participants who received at least one dose of medication (FPX or UFH).||percentage of participants|||Number
802237|NCT00981409|Secondary|Total Perfusion Score at Baseline and Mean Change From Baseline at Days 5-10|The perfusion score (0: no perfusion; 0.25, 0.5, 0.75, 1: normal) in each of the six lobes of the lung was adjudicated blindly by the Central Independent Adjudication Committee of Efficacy (CIACE). Total perfusion score (r) was calculated as: r = (0.25 x right lower lobe) + (0.12 x right middle lobe) + (0.18 x right upper lobe) + (0.20 x left lower lobe) + (0.12 x lingula) + (0.13 x left upper lobe).|Baseline, Days 5-10 (the day when the medication [FPX or UFH] was finished /discontinued) (+/-1)|Full Analysis Set (FAS): all participants receiving at least one dose of medication (FPX or UFH) who had efficacy data and had a confirmed diagnosis of acute pulmonary thromboembolism (PE)||points on a scale||Standard Deviation|Mean
802238|NCT00981409|Secondary|The Percentage of Participants With Perfusion Lung Scan Results Scored as Improved, no Change, or Worse|"Improved, No change, or Worse was adjudicated blindly by the Central Independent Adjudication Committee of Efficacy (CIACE). Each category is adjudicated by comparison with the perfusion score at baseline by the CIACE."|Baseline, Days 5-10 (the day when the medication [FPX or UFH] was finished /discontinued) (+/-1)|Full Analysis Set (FAS): all participants receiving at least one dose of medication (FPX or UFH) who had efficacy data and had a confirmed diagnosis of acute pulmonary thromboembolism (PE)||percentage of participants|||Number
802239|NCT00981409|Secondary|The Percentage of Participants With Recurrent or New Symptomatic/Asymptomatic Venous Thromboembolism (VTE) (by Type)|VTE (pulmonary thromboembolism [PE] and/or deep vein thromboembolism [DVT]) was adjudicated blindly by the Central Independent Adjudication Committee of Efficacy (CIACE).|From Day 1 to Day 90 (±7 days)|Full Analysis Set (FAS): all participants receiving at least one dose of medication (FPX or UFH) who had efficacy data and had a confirmed diagnosis of acute pulmonary thromboembolism (PE)||percentage of participants|||Number
802240|NCT00981409|Primary|The Percentage of Participants With Recurrent or New Symptomatic Venous Thromboembolism (VTE)|VTE (pulmonary thromboembolism [PE] and/or deep vein thromboembolism [DVT]) was adjudicated blindly by the Central Independent Adjudication Committee of Efficacy (CIACE).|From Day 1 to Day 90 (±7 days)|Full Analysis Set (FAS): all participants receiving at least one dose of medication (FPX or UFH) who had efficacy data and had a confirmed diagnosis of acute pulmonary thromboembolism (PE)||percentage of participants|||Number
802241|NCT00981435|Secondary|Intraocular Inflammation|The count of patients with inflammation defined as anterior chamber cells was measured in each study arm.|Up to week 12|Patient data was incomplete due to inadequate measurement or follow up as follows: Artificial tears (31 enrolled, 31 available for data acquisition); Non-steroidal anti-inflammatory (29 enrolled, 26 available for data acquisition); Steroid (37 enrolled, 35 available for data acquisition).||Participants|||Count of Participants
803728|NCT00985725|Secondary|Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|Baseline|FAS||percentage of participants|||Number
802242|NCT00981435|Primary|Intraocular Pressure (IOP) Change|IOP will be measured before and at 6 and 12 weeks after intervention using Goldman tonometry.|Baseline to Week 12|Patient data was incomplete due to inadequate measurement or follow up as follows: Artificial tears (31 enrolled, 27 available for data acquisition); Non-steroidal anti-inflammatory (29 enrolled, 26 available for data acquisition); Steroid (37 enrolled, 33 available for data acquisition).||mmHg||Standard Deviation|Mean
802243|NCT00981461|Primary|Changes in Terminal Hair Count Week 16 and 26 Weeks Over Baseline|The primary analysis of effectiveness was an analysis of covariance, which separately modeled terminal hair count at Week 16 and Week 26 as a function of treatment group (HairMax LaserComb 2009 9 Beam vs.control), study center, age (as a continuous variable), and Fitzpatrick Skin Type classification (as a categorical variable with four levels). The active group was compared to the control device using least squares means with a two-sided test at the 5% level of significance.|Baseline, 16 weeks, 26 weeks|||hairs per cm^2||Standard Deviation|Mean
802249|NCT00973622|Primary|A Difference Score for the Log Value of K.|K is a output value, a summary statistic, derived from a hyperbolic function that summarizes the rate at which monetary values are discounted according to the time they are received. The value of K can either increase or decrease from its baseline value. For example, an increase in K would indicate that the participant is choosing to receive larger amounts of money at a later point in time. A decrease would suggest the opposite - lesser amounts of money at an earlier point in time). The difference score is calculated from baseline to that immediately after 10 or 20 Hz rTMS.|baseline and immediately after stimulation, an average of 25 seconds.|All participants that attended at least one session and provided at least some outcome data were included in the analyses||log transformed values of K||Standard Deviation|Log Mean
802250|NCT00973700|Secondary|Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age|"Number of subjects with specified solicited local and systemic reactions in adult subjects (18 to 64 years of age).
Note: 1) postvac. 1 = after the first vaccination and 2) postvac. 2 = after the second vaccination.
The analyses were performed on the safety set."|7 days after each vaccination|The analysis is done on the safety set.||Number of subjects|||Number
802251|NCT00973700|Secondary|Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age|"Number of subjects with specified solicited local and systemic reactions in adult subjects (9 to 17 years of age).
Postvac: postvaccination Analges: analgesics Antipyr: antipyretics The analyses were performed on the safety set.
Note: 1) postvac 1 = after the first vaccination and 2) postvac 2 = after the second vaccination."|7 days after each vaccination|The analysis is done on the safety set.||Number of subjects|||Number
802252|NCT00973700|Secondary|Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age|"Number of subjects with specified solicited local and systemic reactions in adult subjects (3 to <9 years of age).
Postvac: postvaccination; Analges: analgesics; Antipyr: antipyretics. The analyses were performed on the safety set. Note: 1) postvac 1 = after the first vaccination and 2) postvac 2 = after the second vaccination"|7 days after each vaccination|The analysis is done on the safety set.||Number of subjects|||Number
802253|NCT00973700|Secondary|Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years|"Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer.
The analyses were performed on the per-protocol set (PPS)."|7 days and 21 days after each vaccination|The analysis is done on the per-protocol set.||Percentages of Subjects||95% Confidence Interval|Number
802254|NCT00973700|Secondary|HI GMR, in Adults 18 to 64 Years|"Geometric Mean Ratios (GMRs) of hemagglutination inhibition (HI) antibody assay (ratio of post-vaccination versus pre-vaccination HI titers).
The analyses were performed on the Per-Protocol Set (PPS)."|Day 1 to day 387|The analysis is done on the per-protocol set.||Ratio||95% Confidence Interval|Geometric Mean
802255|NCT00973700|Secondary|HI GMRs, in 3 to <9 Years and 9 to 17 Years|"Geometric Mean Ratios (GMRs) of hemagglutination inhibition (HI) antibody assay (ratio of post-vaccination versus pre-vaccination HI titers).
The analyses were performed on the the per-protocol set (PPS)."|Day 1 to day 387|The analysis is done on the per-protocol set.||Ratio||95% Confidence Interval|Geometric Mean
802256|NCT00973700|Secondary|Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years|"Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer.
The analyses were performed on the Per-Protocol Set (PPS)."|Day 1 to day 387|The analysis is done on the per-protocol set.||Percentages of Subjects||95% Confidence Interval|Number
802257|NCT00973700|Secondary|Age Distribution at Baseline||Baseline|The overall number of baseline participants.||years||Standard Deviation|Mean
802258|NCT00973700|Primary|Percentage of Subjects With Seroconversion and HI Titer ≥ 1:40 in Adults 18 to 64 Years of Age|"Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer.
Analyses were performed on the Per-Protocol set (PPS)."|Day 1 to day 387|The analysis was done on the per-protocol set.||Percentages of Subjects||95% Confidence Interval|Number
802259|NCT00973700|Primary|Percentage of Subjects With Seroconversion and HI Titer ≥1:40 in Children 3 to 17 Years of Age|"Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer.
The analyses were performed on the Per-Protocol Set (PPS)."|Day 1 to day 387|The analysis was done on the per-protocol set.||Percentages of Subjects||95% Confidence Interval|Number
802260|NCT00973739|Secondary|Participants Experiencing Grade 3 Toxicities (CTCAE)|Toxicity was assessed throughout the study, up to one year.|Baseline through one year|||participants|||Number
802261|NCT00973739|Secondary|Participants Experiencing Grades 1 or 2 Toxicities (CTCAE)|Toxicity was assessed throughout the study, up to one year.|Baseline through one year|||participants|||Number
802262|NCT00973739|Secondary|Estimated Volumetric Progression Free Survival for Hearing at 12 Months|"Measurements were taken every three months, up to one year. Estimated volumetric progression free survival (PFS) was measured from date of enrollment to date of hearing progression. PFS was analyzed using the Kaplan–Meier method in terms of overall PFS (volumetric or hearing progression), volumetric progression, and hearing progression.
Point estimates for PFS with 95% confidence intervals (CIs) were calculated from Kaplan–Meier curves."|Every three months for one year|This analysis is based on the 17 evaluable patients.||Liklihood of PFS at 12 months||95% Confidence Interval|Mean
802263|NCT00973739|Primary|Estimated Volumetric Progression Free Survival at 12 Months|"Measurements were taken every three months, up to one year. Estimated volumetric progression free survival (PFS) was measured from date of enrollment to date of volumetric progression. PFS was analyzed using the Kaplan–Meier method in terms of overall PFS (volumetric or hearing progression), volumetric progression, and hearing progression.
Point estimates for PFS with 95% confidence intervals (CIs) were calculated from Kaplan–Meier curves."|Every three months for one year|This analysis is based on the 17 evaluable patients.||Liklihood of PFS at 12 months||95% Confidence Interval|Mean
802264|NCT00973752|Primary|Overall Survival at One Year|The number of participants alive one year after baseline.|1 years|||Participants|||Count of Participants
802265|NCT00973765|Primary|Treatment Failures at 7 Days|worsening abscess or new recurrence of abscess|7 days|||participants|||Number
802266|NCT00973921|Secondary|Correlation of Stent Diameter Measurements Between the QCA and IVUS .|The mean difference between stent diameter measurements at the narrowest point (Minimum Stent Diameter) by QCA and by IVUS|On day of procedure|Total of 40 consecutive patients who underwent PCI with stent implantation were enrolled. Only 31 of them had analyzable IVUS results.||mm||Standard Deviation|Mean
802267|NCT00973921|Primary|The Accuracy (Percent of Correct Decisions) of Post-dilatation Decisions Based on QCA Analysis, With IVUS as Gold Standard.|IVUS was used as a gold standard to decide if a stent required post dilatation or not. Independently and blindly, QCA analysis was used to determine the same decisions. The accuracy of SO was determined as the percentage of correct decisions compared to the gold standard.|On procedure day|Total of 40 consecutive patients who underwent PCI with stent implantation were enrolled. Only 31 of them had analyzable IVUS results.||percentage of correct decision by QCA|||Number
802268|NCT00973921|Secondary|Correlation of Stent Diameter Measurements Between the StentOptimizer and IVUS .|The mean difference between stent diameter measurements at the narrowest point (Minimum Stent Diameter) by SO and by IVUS.|On day of procedure|Total of 40 consecutive patients who underwent PCI with stent implantation were enrolled. Only 31 of them had analyzable IVUS results.||mm||Standard Deviation|Mean
802269|NCT00973921|Primary|The Accuracy (Percent of Correct Decisions) of Post-dilatation Decisions Based on the Stent Optimizer (SO) Software, With IVUS as Gold Standard.|IVUS was used as a gold standard to decide if a stent required post dilatation or not. Independently and blindly, The SO software was used to determine the same decisions. The accuracy of SO was determined as the percentage of correct decisions compared to the gold standard.|On the procedure day|Total of 40 consecutive patients who underwent PCI with stent implantation were enrolled. Only 31 of them had analyzable IVUS results.||percentage of correct decisions by SO|||Number
802270|NCT00974051|Primary|Blood Glucose Nadir|BG nadir overnight after intervention|overnight hours|||mg/dl||Standard Deviation|Mean
802271|NCT00974051|Secondary|Percent of Nighttime Glucose Levels >250 mg/dl||10:00pm to 6:00am|||percentage of overnght glucose values|||Number
802274|NCT00974090|Secondary|Change From Baseline in 2-hour Postprandial Plasma Glucose at Week 12|The change from Baseline in 2-hour Postprandial Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline 2-hour Postprandial Plasma Glucose as a covariate.|at Week 0 and Week 12|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization.||mg / dL||Standard Error|Least Squares Mean
802275|NCT00974090|Secondary|Change From Baseline in the Areas Under the Curve From 0 to 2 h (AUC0-2h) for Postprandial Plasma Glucose at Week 12|The change from Baseline in AUC0-2h for Postprandial Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline AUC0-2h for Postprandial Plasma Glucose as a covariate.|0, 0.5, 1, 2 hours post-dose at Week 0 and Week 12|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization.||mg・hr/dL||Standard Error|Least Squares Mean
802276|NCT00974090|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 12|The change from Baseline in Fasting Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline Fasting Plasma Glucose as a covariate.|at Week 0 and Week 12|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization. Analysis based on last observation carried forward, where the last postbaseline double-blind observed value was carried forward and used for Week 12 where data was missing.||mg / dL||Standard Error|Least Squares Mean
802277|NCT00974090|Primary|Change From Baseline in HbA1c at Week 12|The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate.|at Week 0 and Week 12|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization. Analysis based on last observation carried forward, where the last postbaseline double-blind observed value was carried forward and used for Week 12 where data was missing.||percentage of HbA1c||Standard Error|Least Squares Mean
802278|NCT00974220|Secondary|Cycle Exercise Endurance Time|Constant workrate cycle endurance during tests at 75% of the peak incremental workrate|10-minutes post-treatment|Subjects completing both treatment arms were included in this analysis||minutes||Standard Error|Mean
802279|NCT00974220|Primary|Dyspnea Intensity Measured by the 10-point Borg Scale During Cycle Exercise|"The 10-point Borg scale ranges from 0 nothing at all to 10 maximal/extremely strong and was used to rate the intensity of dyspnea during exercise; therefore, a decrease in this rating signifies an improvement. Dyspnea intensity was assessed at the highest equivalent standardized time achieved in both post-treatment constant work rate cycle exercise tests."|10-minutes post-treatment|Subjects who completed both treatment arms of the crossover study were included in the primary analysis.||units on a scale||Standard Error|Mean
802280|NCT00974233|Secondary|Overall Survival|Overall survival (OS) is defined as the time from the day of first study drug administration until death from any cause.|42 months (6 months induction therapy, 12 months maintenance, 24 months long-term follow-up)|Overall survival (OS) was measured for all enrolled subjects as the time from the day of first study drug administration until death from any cause.||months||95% Confidence Interval|Median
802281|NCT00974233|Secondary|Toxicities Observed With Induction Chemotherapy and Maintenance Therapy|Toxicities were reported using the Common Terminology Criteria for Adverse Events, version 3.0.|42 months (6 months induction therapy, 12 months maintenance, 24 months long-term follow-up)|Toxicities were reported using the Common Terminology Criteria for Adverse Events, version 3.0.||participants|||Number
802282|NCT00974233|Secondary|Objective Response Rate (Complete + Partial Responses)|Response and progression in cases of SLL were evaluated using the International Working Group Criteria for response in NHL (Cheson, et al 1996). Response and progression in cases of CLL were evaluated using the NCI-sponsored CLL Working Group guidelines for CLL (Cheson, et al 2007). Complete response defined as resolution enlarged lymph nodes, spleen and liver; normalization of blood counts (neutrophils, hemoglobin, platelets); no residual CLL/SLL detectable in the bone marrow. Partial response defined as 50% or more reduction in size of enlarged lymph nodes, liver or spleen; 50% or more improvement of blood counts; 50% or more improvement in the blood lymphocyte count. Progressive disease defined as 50% or more increase in the combined measurements of at least 2 lymph nodes as measured on CT scans or the appearance of new enlarged lymph nodes; 50% of more increase in the size of the spleen or liver; 50% or more increase in blood lymphocyte count.|42 months (6 months induction therapy, 12 months maintenance, 24 months long-term follow-up)|||participants|||Number
802283|NCT00974233|Primary|Progression-free Survival|Progression-free survival (PFS) is defined as the time from the day of first study drug administration until progression of CLL/SLL or death from any cause. PFS is reported as the proportion of participants with PFS up to 42 months.|42 months (6 months induction therapy, 12 months maintenance, 24 months long-term follow-up)|||Proportion of participants||95% Confidence Interval|Median
802284|NCT00974233|Primary|Progression Free Survival|The primary endpoint of this study was progression-free survival (PFS), defined as the number of days from the day of first study drug administration to the day the patient experienced disease progression or death from any cause. Response and progression in cases of small lymphocytic lymphoma(SLL) were evaluated using the International Working Group Criteria for response in NHL (Cheson, et al 1996). Response and progression in cases of chronic lymphocytic leukemia (CLL) were evaluated using the NCI-sponsored CLL Working Group guidelines for CLL (Cheson, et al 2007).|42 months (6 months induction therapy, 12 months maintenance, 24 months long-term follow-up)|The study was designed to test the null hypothesis that the median PFS with induction BR and maintenance lenalidomide is at most 18 months versus the alternative hypothesis that median PFS is >18 months, at a one-sided significance level of 0.10 with a power of 80%.||months||95% Confidence Interval|Median
802285|NCT00974246|Primary|Pulmonary Function FEC/FVC Ratio at 16 Weeks|To measure whether pulmonary function, determined by the ratio between FEC (Forced Expiratory Capacity) and FVC (Forced Vital Capacity), improved during 16 weeks of Advair Diskus administration.|16 weeks|||ratio||Standard Deviation|Mean
812458|NCT01070784|Primary|Clinical Laboratory Test: Clinical Chemistry- S- Calcium|Change from baseline|Baseline and 52 week after|||mg/dL||Standard Deviation|Mean
802286|NCT00974246|Primary|To Determine if Changes in Pulmonary Function (FEC/FVC) Were Associated With a Reduction in Depression as Assessed by Using the Cornell Depression Scale or Section D SUM of the Minimum Data Set 3.0 During Advair Diskus Treatment.|FEC is Forced Expiratory Capacity and FVC is Forced Vital Capacity. The Cornell Depression Scale ranges from 0-38, with a score 12 points or more indicating probable depression. Section D SUM o f the Minimum Date Set 3.0 is an assessment tool of health status for all residents (regardless of payer) of long-term care facilities certified to participate in Medicare or Medicaid. Scores range from 0 to 27, with a higher score indicating more depression.|16 weeks|||units on a scale||Standard Deviation|Mean
802287|NCT00974246|Primary|To Determine the Effect of Treating COPD Patients With Advair Diskus for 16 Weeks on the Cornell Depression Scale or Section D SUM of the Minimum Data Set 3.0|The Cornell Depression Scale ranges from 0-38, with a score 12 points or more indicating probable depression. Section D SUM o f the Minimum Date Set 3.0 is an assessment tool of health status for all residents (regardless of payer) of long-term care facilities certified to participate in Medicare or Medicaid. Scores range from 0 to 27, with a higher score indicating more depression.|16 weeks|||units on a scale||95% Confidence Interval|Mean
802288|NCT00974311|Secondary|Circulating Tumor Cell (CTC) Conversion Rate|RESULTS FOR CTC WILL BE REPORTED IN 2014|During study period (up to 3 years)||||||
802289|NCT00974311|Secondary|European Quality of Life Five-Domain Scale (EQ-5D)|"RESULTS FOR EQ-5D WILL BE REPORTED in Q4 2013.
The EQ-5D is a standardized instrument for use as a measure of quality of life. Five parameters (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) were assessed on 3-point categorical scales ranging from “no problem” to “severe problem.” Higher scores reflect worse quality of life."|At Week 13 visit||12/2013||||
802290|NCT00974311|Secondary|Percentage of Patients With Soft-tissue Objective Response|"The best overall soft tissue response as assessed using RECIST v1.1 during the study was summarized using the Investigators’ response assessments and also the derived response assessments by treatment group. Only patients with measurable soft tissue disease at screening were included in this analysis. Patients with measurable disease at screening are patients who had at least 1 target lesion identified per RECIST v1.1 at screening.
Percentage of Participants summarizes the number of patients with complete or partial objective response (%).
Soft Tissue assessment based on Eisenhauer EA, Therasse P, Bogaerts J et al. New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1). Eur J Cancer 2009; 45:228-247."|During study period (up to 3 years)|Intent to Treat (ITT) with Measurable Disease. Patients who were part of the ITT Population and had measurable soft tissue disease at screening, defined by at least 1 target lesion according to RECIST v1.1.||Percentage of participants|||Number
802291|NCT00974311|Secondary|Percentage of Patients With Prostate Specific Antigen (PSA) Response|Patients were evaluable for PSA response rate if they had a PSA level measured at baseline and at least 1 post-baseline assessment. Both PSA responses of > 50% and > 90% were determined. PSA responses required confirmation with a subsequent assessment that was conducted at least 3 weeks later.|During study period (up to 3 years)|Evaluable Intent to Treat. Patients who were part of the ITT Population and had a PSA level measured at baseline and at least 1 post-baseline assessment.||Percentage of Participants|||Number
802292|NCT00974311|Secondary|Percentage of Patients With Pain Palliation|The proportion of patients with pain palliation was assessed for patients with a stable and sufficient pain burden at study entry. Pain burden was measured by question #3 of the Brief Pain Inventory (Short Form). This scale measures pain on a 0 to 10 scale with 0 indicating no pain and 10 indicating pain as bad as you can imagine. Pain palliation at Week 13 was determined for the proportion of men with baseline bone metastasis(es) who had baseline pain attributable to the metastasis(es). Palliation was defined as ≥ 30% reduction in average pain score at Week 13 compared to baseline without a ≥ 30% increase in analgesic use.|During study period (up to 3 years)|Evaluable ITT Population. Patients with metastatic bone disease at baseline; provided answers to Question #3 of the Brief Pain Inventory – Short Form for a minimum of 4 out of 7 days in the baseline run-in period; stable baseline pain; stable analgesic use; and had an average pain score during the baseline run-in period of ≥ 4.||Percentage of Participants||95% Confidence Interval|Number
802293|NCT00974311|Secondary|Time to Prostate-specific Antigen (PSA) Progression|"Time to PSA progression was defined as time from randomization to PSA progression. Patients who did not reach the endpoint were right censored at their last assessment or for patients with no post-baseline PSA assessment, date of randomization.
For patients with PSA declines at Week 13, the PSA progression date was defined as the date that a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the nadir was documented, which was confirmed by a second consecutive value obtained 3 or more weeks later (required only if PSA progression did not occur at last PSA assessment). For patients with no PSA declines at Week 13, PSA progression date was defined as the date that a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the baseline was documented, which was confirmed by a second consecutive value 3 or more weeks later (required only if PSA progression did not occur at last PSA assessment)."|Baseline and at every study visit from week 13 while on study drug (up to 3 years)|Intent to Treat (ITT) - All Patients Randomized||Months||95% Confidence Interval|Median
802294|NCT00974311|Secondary|Functional Assessment of Cancer Therapy - Prostate (FACT-P)|"The FACT-P questionnaire is a 39-item questionnaire consisting of 5 domains; “physical well-being,” “social/family well-being,” “emotional well-being,” “functional well-being,” and “additional concerns” (consisting of items relating to prostate cancer and its treatment). Each item can be answered on a scale of 0–4. The sum of scores on all 5 domains constitutes the FACT-P.
Patients were defined as having a quality of life response if they had a 10-point improvement in their global FACT-P score, as compared with baseline, on two consecutive measurements obtained at least 3 weeks apart."|During study period (up to 3 years)|Evaluable Intent to Treat (ITT) - all patients who were part of the ITT Population and had a global FACT-P score at baseline and at least 1 post-baseline assessment.||Percentage of participants||95% Confidence Interval|Number
802295|NCT00974311|Secondary|Time to First Skeletal-related Event|The time to first skeletal-related event was defined as time from randomization to the occurrence of the first skeletal-related event. Patients were assessed for skeletal-related events at regularly scheduled visits. A skeletal-related event was defined as radiation therapy or surgery to bone, pathologic bone fracture, spinal cord compression, or change of antineoplastic therapy to treat bone pain. Patients who did not reach the endpoint were right censored at their last assessment.|During study period (up to 3 years)|Intent to Treat (ITT) - All Patients Randomized||Months||95% Confidence Interval|Median
802296|NCT00974311|Secondary|Radiographic Progression-free Survival|Radiographic progression-free survival was defined as time from randomization to the earliest objective evidence of radiographic progression or death due to any cause. Patients were assessed for objective disease progression at regularly scheduled visits. The consensus guidelines of the Prostate Cancer Clinical Trials Working Group 2 were taken into consideration for the determination of disease progression. Radiographic disease progression was defined by RECIST 1.1 for soft tissue disease, or the appearance of two or more new bone lesions on bone scan. Progression at the first scheduled reassessment at Week 13 required a confirmatory scan 6 or more weeks later. Patients who did not reach the endpoint were right censored at their last assessment.|During study period (up to 3 years)|Intent to Treat (ITT) - All Patients Randomized||Months||95% Confidence Interval|Median
802297|NCT00974311|Primary|Overall Survival|Survival is defined as time from randomization to death due to any cause. The duration of overall survival was right-censored for patients who were lost to follow-up since randomization or not known to have died at the data analysis cutoff date (this included patients who were known to have died after the data analysis cutoff date).|During study period (up to 3 years)|Intent to Treat (ITT) - All Patients Randomized||Months||95% Confidence Interval|Median
802298|NCT00974363|Secondary|Antibody Concentrations Against the Vaccine Polysaccharides|Antibody concentrations against polysaccharide A (anti-PSA), polysaccharide C (anti-PSC), polysaccharide W-135 (anti-PSW-135) and polysaccharide Y (anti-PSY) assessed were equal to or above (≥) the cut-off values of 0.3 micrograms/milliliter (µg/mL ) and 2.0 micrograms/milliliter (µg/mL). Concentration of antibodies was determined by enzyme-linked immunosorbent assay (ELISA).|At Month 24 post primary dose|The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom assay results were available for at least one tested antigen.||μg/mL||95% Confidence Interval|Geometric Mean
802299|NCT00974363|Secondary|Number of Subjects With Antibody Concentrations Against the Vaccine Polysaccharides|Antibody concentrations against polysaccharide A (anti-PSA), polysaccharide C (anti-PSC), polysaccharide W-135 (anti-PSW-135) and polysaccharide Y (anti-PSY) assessed were equal to or above (≥) the cut-off values of 0.3 micrograms/milliliter (µg/mL ) and 2.0 micrograms/milliliter (µg/mL). Concentration of antibodies was determined by enzyme-linked immunosorbent assay (ELISA).|At Month 24 post primary dose|The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom assay results were available for at least one tested antigen.||Subjects|||Number
802300|NCT00974363|Secondary|Antibody Titers Against the Vaccine Meningococcal Serogroups|Seropositivity status was defined as the anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) titers equal to or above the cut-off value of 1:128. Antibody titers were presented as geometric mean titers (GMTs). The blood analyses were performed at the Public Health of England`s (PHE) laboratory and at GSK Biologicals’ laboratory.|At Months 24, 36, 48 and 60 post primary dose|The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom assay results were available for at least one tested antigen.||Titers||95% Confidence Interval|Geometric Mean
802301|NCT00974363|Secondary|Number of Seropositive Subjects Against the Vaccine Meningococcal Serogroups|A seropositive subject was defined as a subject who had the anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:128. The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers. The blood analyses were performed at the Public Health of England`s (PHE) laboratory and at GSK Biologicals’ laboratory.|At Months 24, 36, 48 and 60 post primary dose|The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom assay results were available for at least one tested antigen.||Subjects|||Number
802302|NCT00974363|Primary|Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups|A seroprotected subject was defined as a subject who had anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:8. The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers. The blood analyses for this timepoint were performed solely at the Public Health of England`s (PHE) laboratory.|At Month 60 post primary dose|The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom assay results were available for at least one tested antigen.||Subjects|||Number
802303|NCT00974363|Primary|Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups|A seroprotected subject was defined as a subject who had anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:8. The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers. The blood analyses for this timepoint were performed solely at the Public Health of England`s (PHE) laboratory.|At Month 48 post primary dose|The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom assay results were available for at least one tested antigen.||Subjects|||Number
802304|NCT00974363|Primary|Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups|A seroprotected subject was defined as a subject who had anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:8. The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers. The blood analyses for this timepoint were performed solely at the Public Health of England`s (PHE) laboratory.|At Month 36 post primary dose|The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom assay results were available for at least one tested antigen.||Subjects|||Number
802305|NCT00974363|Primary|Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups|A seroprotected subject was defined as a subject who had anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:8. The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers. The blood analyses were performed at the GSK Biologicals’ laboratory.|At Month 24 post primary dose|The analysis was performed on the According-to-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom assay results were available for at least one tested antigen.||Subjects|||Number
802663|NCT00983346|Primary|Bone Anabolic Effect of Bortezomib in Patients With Smoldering Myeloma.|The primary endpoint is the change in bone Alkaline Phosphatase at baseline and 6 weeks.|Baseline and 6 weeks|Only 13 patents had bone alkaline phosphatase measured at the appropriate time points out of the 17 that completed the study||Percentage of Baseline Value|||Number
802306|NCT00974376|Primary|Percentage of Negative Urinary Drug Screens (UDS) for Cannabis at 12 Weeks Following Administration of Gabapentin or Placebo During the Double Blind Period|Express Results Integrated Multi-Drug Screen Cups were used to obtain a semi-quantitative urine drug screen for delta-9-THC. Submitted UDS would yield a positive result when the concentration of THC-COOH in urine exceeded 50 ng/mL. Specimens were collected weekly. Two analytical approaches were used: one where any missed UDS test was assumed positive (i.e intent-to-treat (ITT)) and another where missed UDS were considered missing at random (MAR).|12 weeks|Two participants in the gabapentin group and one in the placebo group were lost to follow up after randomization and did not submit any UDS for testing while on study. Two participants in the placebo group withdrew from the study at the week 1 visit, and thus did not submit any UDS for testing while on study.||percentage of negative UDS||Standard Deviation|Mean
802307|NCT00974480|Secondary|Tolerance Evaluated by Investigator.|"Tolerance was studied by evaluating scaling, dryness, erythema and burning/itching sensation on a 5-point scale.
Scaling, Dryness and Erythema Evaluations
- None (0) - Very Severe = (4)
Burning and Itching Evaluation Scale
None (0) = Normal, no discomfort
Mild (1) = Slight discomfort that is not bothersome
Moderate (2) = Discomfort that is somewhat bothersome
Marked (3) = Discomfort that is bothersome and that occasionally interferes with normal daily activities
Severe (4) = Continuous discomfort that interferes with normal daily activities"|12, 24 weeks|Analysis was intent to treat (ITT) with Last Observation Carried Forward (LOCF) imputation technique.||Units on a scale||Standard Deviation|Mean
802308|NCT00974480|Secondary|Facial Skin Self-evaluation.|A visual analog scale of 13 evaluations were performed by the subject. Scale is from 1 - 10 for each evaluation individually evaluated. 0 = absent, 10 = important.|12, 24 weeks|Analysis was intent to treat (ITT) with Last Observation Carried Forward (LOCF) imputation technique.||Units on a scale||Standard Deviation|Mean
802309|NCT00974480|Secondary|Sensitivity of the Face Evaluated by Subject.|"Sensitivity of the entire face evaluated by the subject was performed using 4 different 10 cm visual analog scales (pruritus, tingling, burning, tightness). Each score was analysed separately.
Each score is from 0 = absent to 10 important."|12, 24 weeks|Analysis was intent to treat (ITT) with Last Observation Carried Forward (LOCF) imputation technique.||Units on a scale||Standard Deviation|Mean
802310|NCT00974480|Secondary|Clinical Skin Evaluation.|A clinical skin evaluation of the face was performed by a dermatologist using 8 scales (skin hydration, radiance, roughness, spots, laxity, skin tone homogeneity, softness, relief (variations in depth)). The individual scores were totalled (worst = 0, best = 47) and the total score was used for analyses.|12, 24 weeks|Analysis was intent to treat (ITT) with Last Observation Carried Forward (LOCF) imputation technique.||Units on a scale||Standard Deviation|Mean
802311|NCT00974480|Secondary|Area Ratio - Analysis of Skin Replicas of Crow's Feet.|An illuminator is used to cross illuminate the specimen (silicone mold replicas) perpendicular to the major lines which accentuate the surface details. The resulting image which consists of a series of shadows that directly correspond to the pattern of wrinkles is digitized for analysis. One can measure changes in skin surface topography by selecting an area range (shadow size) that allows one to directly determine the projected area of the shadowed region associated with the wrinkles and major lines. The Area Ratio is the area of the shadows. The higher the ratio, the greater the wrinkling.|24 weeks|Only the per protocol (PP) population was considered for this analysis. Early termination and lost subjects were excluded from this analysis. Furthermore, some replicas of subjects who completed the study could not be analyzed with precision and were consequently excluded from the analysis by the laboratory.||mm²||Standard Deviation|Mean
802312|NCT00974480|Secondary|Skin Elasticity.|Skin elasticity was measured with a DermaLab device (Cortex Technology, Denmark) equipped with a skin elasticity probe. Pressure required to raise the skin 1mm was recorded. Measurements were performed on the upper cheeks and care was taken to use the same location for all measurements. Final measurements were the average of left and right cheeks. When the product is a moisturizer, lower pressures are indicative of efficacy.|12, 24 weeks|Analysis was intent to treat (ITT) with Last Observation Carried Forward (LOCF) imputation technique.||kilo Pascals||Standard Deviation|Mean
802313|NCT00974480|Secondary|Skin Hydration (Conductance)|"Skin hydration was measured with a DermaLab device (Cortex Technology, Denmark) equipped with a skin hydration probe.
Measurements were performed in a room with controlled temperature (20°C +/-2) and humidity (45% +/- 15%). All measurements were performed at least 30 minutes after the subject had been transferred into this room. Care was taken to use the same cheek for each subject throughout the study. Higher values indicate greater hydration."|12, 24 weeks|Analysis was intent to treat (ITT) with Last Observation Carried Forward (LOCF) imputation technique.||µsiemens (µmho)||Standard Deviation|Mean
802314|NCT00974480|Secondary|Trans-epidermal Water Loss (TEWL).|Trans Epidermal Water Loss (TEWL) was measured with a DermaLab device (Cortex Technology, Denmark) equipped with a TEWL probe. Measurements were performed with the subject lying down on the back in a room with controlled temperature (20°C +/-2) and relative humidity (45% +/- 15%). All measurements were performed at least 30 minutes after the subject was transferred into this room. The measurements were performed on the cheek. Care was taken to use the same cheek for each subject throughout the study.|12, 24 weeks|Analysis was intent to treat (ITT) with Last Observation Carried Forward (LOCF) imputation technique.||g / m² / h||Standard Deviation|Mean
802315|NCT00974480|Secondary|Photographic Evaluation by a Panel of Blinded Dermatologists.|"A blinded panel of two dermatologists had to identify independently which of the two photographs had an improvement or if there was no noticeable difference between them. The two photographs of each subject were randomized to keep the blind.
When the Week 24 photograph was selected as the one showing an improvement, it was scored by the statistician as “improvement”. When the Day 0 photograph was selected as the one showing an improvement, it was scored by the statistician as “worsening”. When there was no noticeable difference between the photographs, it was scored as “stable”."|24 weeks|Analysis was intent to treat (ITT). Photographs taken at early termination visit were not available for every early termination subject as some subjects refused to have their photographs taken. Thus, early termination and lost to follow-up subjects were excluded from this analysis. The total number of subjects included in the ITT analysis was 92.||Participants|||Number
802329|NCT00974675|Primary|Apparent Terminal Elimination Phase Half-Life (t[1/2]el) for CAT-354 After First Dose|Terminal elimination phase half-life is the time measured for the serum concentration to decrease by one half.|Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21|PK population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax.||days||Standard Deviation|Mean
802316|NCT00974480|Primary|Skin Aging Measured With the Photonumeric Scale.|Scoring was accomplished by matching each part of the face (forehead, glabella, corners of the mouth, nasal labial fold, crow's feet, below eyes and upper lip) to photographs in the scales and reporting the appropriate number in the tables. All individual scores were added to obtain the total score (Less signs of skin aging = 0, more signs of skin aging = 41.6).|12, 24 weeks|Analysis was intent to treat (ITT) with Last Observation Carried Forward (LOCF) imputation technique.||Units on a scale||Standard Deviation|Mean
802317|NCT00974571|Secondary|Physician's Global Evaluation of Allergic Rhinitis|An evaluation by the physician, administered at week 4 of the study (or upon discontinuation) using a 7-point scale [Score 0 (best) to 6 (worst)], of the change in symptoms as compared to the beginning of the study.|End of the first 4 weeks in 6-week treatment period|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle. Since only 1 measurement was obtained during the treatment period, no missing values were imputed.||Scores on a scale||95% Confidence Interval|Least Squares Mean
802318|NCT00974571|Secondary|Patient's Global Evaluation of Allergic Rhinitis|An evaluation by the patient, administered at week 4 of the study (or upon discontinuation) using a 7-point scale [Score 0 (best) to 6 (worst)], of the change in symptoms as compared to the beginning of the study.|End of the first 4 weeks in 6-week treatment period|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle. Since only 1 measurement was obtained during the treatment period, no missing values were imputed.||Scores on a scale||95% Confidence Interval|Least Squares Mean
802319|NCT00974571|Secondary|Mean Change From Baseline in Composite Symptoms Score|Composite Symptoms Scores were computed as the average of the Daytime Nasal Symptoms Scores [Score 0 (best) to 3 (worst)]. and Nighttime Symptoms Scores collected [Score 0 (best) to 3 (worst)].|Baseline and first 4 weeks in 6-week treatment period|All patients who had a baseline and at least one posttreatment measurement were included.||Score 0 (best) to 3 (worst)||95% Confidence Interval|Least Squares Mean
802320|NCT00974571|Secondary|Mean Change From Baseline in Nighttime Symptoms Score|"Mean change from baseline in Nighttime Symptoms Score.
Patients were asked to rate each symptom daily on a 4-point scale [Score 0 (best) to 3 (worst)], and the average score of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings was reported as the Nighttime Symptoms Score."|Baseline and first 4 weeks in 6-week treatment period|All patients who had a baseline and at least one posttreatment measurement were included.||Scores on a scale||95% Confidence Interval|Least Squares Mean
802321|NCT00974571|Primary|Mean Change From Baseline in Daytime Nasal Symptoms Score|"Mean change from baseline in Daytime Nasal Symptoms score.
Patients were asked to rate each nasal symptom of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4-point scale [Score 0 (best) to 3 (worst)]. The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal Symptoms Score."|Baseline and first 4 weeks of a 6-week treatment period|All patients who had a baseline and at least one posttreatment measurement were included.||Scores on a scale||95% Confidence Interval|Least Squares Mean
802322|NCT00974675|Primary|Accumulation Ratio (R0) for CAT-354|Accumulation ratio is calculated as: R0 = AUC(56 - 84)/AUC(0 - 28) where AUC(0 - 28) and AUC(56 - 84) are the area under the serum concentration time curve over a dosage interval determined after the first dose (Day 0 to Day 28) and after the third dose (Day 56 to Day 84), respectively.|Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0 and 56; Pre-dose on Day 28; Day 4, 7, 14, 21, 63 and 84|PK population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||ratio||Standard Deviation|Mean
802323|NCT00974675|Secondary|Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Day 147 that were absent before treatment or that worsened relative to pre-treatment state.|Day 0 to Day 147|Safety population included all participants who received at least 1 dose of IMP (CAT-354 or placebo) including those who did not complete the study.||participants|||Number
802324|NCT00974675|Primary|Observed Serum Concentration for CAT-354 28 Days (C28) After Third Dose||Day 84|PK population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||mcg/mL||Standard Deviation|Mean
802325|NCT00974675|Primary|Observed Serum Drug Concentration for CAT-354 28 Days (C28) After Second Dose||Pre-dose on Day 56|PK population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||mcg/mL||Standard Deviation|Mean
802326|NCT00974675|Primary|Observed Serum Drug Concentration for CAT-354 28 Days (C28) After First Dose||Pre-dose on Day 28|PK population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||mcg/mL||Standard Deviation|Mean
802327|NCT00974675|Primary|Volume of Distribution (Vd) for CAT-354 After First Dose|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Volume of distribution was normalized to the body weight of the participant.|Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21|PK population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax.||mL/kg||Standard Deviation|Mean
802328|NCT00974675|Primary|Clearance (CL) for CAT-354 After First Dose|Clearance of a drug was a measure of the rate at which a drug was metabolized or eliminated by normal biological processes. Clearance was normalized by the body weight of the participant.|Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21|PK population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax.||(mL/day)/kilogram||Standard Deviation|Mean
802330|NCT00974675|Primary|Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC[0 - Infinity]) for CAT-354 After First Dose|AUC (0 - infinity) = Area under the serum concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - infinity). It is obtained from AUC (0 - t) plus AUC (t - infinity).|Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21|PK population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax.||(mcg*day)/mL||Standard Deviation|Mean
802331|NCT00974675|Primary|Area Under the Serum Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC[0 - t]) for CAT-354 After First Dose||Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21|PK population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax.||(mcg*day)/mL||Standard Deviation|Mean
802332|NCT00974675|Primary|Maximum Observed Serum Concentration (Cmax) for CAT-354 After Third Dose||Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 56; Day 63, 84, 105 and 147|PK population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||mcg/mL||Standard Deviation|Mean
802333|NCT00974675|Primary|Maximum Observed Serum Concentration (Cmax) for CAT-354 After Second Dose||Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 28; Day 35|PK population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||mcg/mL||Standard Deviation|Mean
802334|NCT00974675|Primary|Maximum Observed Serum Concentration (Cmax) for CAT-354 After First Dose||Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21|Pharmacokinetic (PK) population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax.||microgram/milliliter (mcg/mL)||Standard Deviation|Mean
802335|NCT00974818|Primary|Response to Treatment|will be assessed by cystoscopy every 3 months (+/- 3 weeks) in the first 2 years after induction.|2 years|Due to a lack of patients accrued to the protocol the protocol was closed and the analysis of the 2 year relapse rates could not be compared.||participants|||Number
802336|NCT00974974|Secondary|"On Time Without Troublesome Dyskinesia"|"On time without troublesome dyskinesiais measured by using the Parkinson's disease diary. On time without troublesome dyskinesia describes a period when the participant experiences decreased Parkinsonian symptoms (e.g. immobility or inability to move with ease) without dyskinesia (i.e. difficulty in performing voluntary movements) that affect daily living."|22 weeks|All randomized subjects||hours||Standard Deviation|Mean
802337|NCT00974974|Secondary|"Off Time"|"Off time hours is measured by using the Parkinson's disease diary. Off time describes a period when the participant experiences increased Parkinsonian symptoms (e.g. immobility or inability to move with ease)."|22 weeks|All randomized subjects||hours||Standard Deviation|Mean
802338|NCT00974974|Primary|"Percentage of Off Time During Waking Hours at End of Study"|"Percentage of off time during waking hours at end of study is measured by using the Parkinson's disease diary. Off time describes a period when the participant experiences increased Parkinsonian symptoms (e.g. immobility or inability to move with ease)."|22 weeks|All randomized subjects||percentage||Standard Deviation|Mean
802339|NCT00975000|Secondary|Time to Parathyroidectomy||56 weeks|Full analysis set who underwent a parathyroidectomy|||||
802340|NCT00975000|Secondary|Percentage of Participants With a Parathyroidectomy||56 weeks|Full analysis set||percentage of participants|||Number
802341|NCT00975000|Secondary|Change From Baseline to the EAP in Urine Phosphorus||Baseline and the EAP (mean of Weeks 22, 24, and 26)|Full analysis set with available data||mg/dL||Standard Deviation|Mean
802342|NCT00975000|Secondary|Change From Baseline to the EAP in Intact Parathyroid Hormone (iPTH)||Baseline and the EAP (mean of Weeks 22, 24, and 26)|Full analysis set||pg/mL||Standard Deviation|Mean
802343|NCT00975000|Secondary|Change From Baseline to the EAP in Corrected Total Calcium||Baseline and the EAP (mean of Weeks 22, 24, and 26)|Full analysis set||mg/dL||Standard Deviation|Mean
802344|NCT00975000|Secondary|Change From Baseline to Week 52 in eGFR|eGFR was calculated using the Modification of Diet in Renal Disease (MDRD) formula.|Baseline and Week 52|Full analysis set with available data||mL/min/1.73 m²||Standard Deviation|Mean
802345|NCT00975000|Secondary|Change From Baseline to the EAP in Mean Serum Phosphorus||Baseline and the EAP (mean of Weeks 22, 24, and 26)|Full analysis set with available data||mg/dL||Standard Deviation|Mean
802346|NCT00975000|Secondary|Percent Change From Baseline to Week 52 in Bone Mineral Density at the Femoral Neck|Bone mineral density (BMD) was measured using dual X-ray absorptiometry (DXA).|Baseline and Week 52|Full analysis set with available data||percent change||Inter-Quartile Range|Median
802347|NCT00975000|Primary|Percentage of Participants With a Mean Corrected Total Serum Calcium Value < 10.2 mg/dL (2.55 mmol/L) During the Efficacy Assessment Phase (EAP)||Weeks 21 to 26 (EAP)|Full analysis set (all randomized participants excluding participants determined to have graft failure prior to week 26)||percentage of participants|||Number
802348|NCT00975130|Secondary|Percentage of Participants Achieving Remission|Remission was defined as achievement of a DAS28-ESR < 2.6.|Start of Month 8, Start of Month 9, Start of Month 10, Start of Month 11, End of Month 12|8 participants (3 poor quality data, 4 without a post-baseline DAS28-ESR, and 1 did not take Part 2 medication) and 7 participants (5 poor data quality, 1 without a DAS28-ESR at baseline, 1 without post-baseline DAS28-ESR) were excluded from the efficacy evaluable population for the IV-GLM 2mg/kg + SC GLM 50 mg and SC-GLM50 arms, respectively.||Percentage of Participants||95% Confidence Interval|Number
802369|NCT00975130|Secondary|Mean Change From Baseline in HAQ-DI by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6|The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802349|NCT00975130|Secondary|Mean Area Under the DAS28-ESR Curve From Study Month 6 to Month 12|"The DAS28-ESR is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR, and participant assessment of disease activity measure on a visual analogue scale. The DAS28-ESR has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). Minimum score=0 (best) to maximum score=10 (worst). The DAS28-ESR area under the curve can be calculated from the DAS28-ESR score versus time curve to provide an assessment of changes in disease activity over time.
The area under the DAS28-ESR score versus time curve was computed using the trapezoidal rule and using raw DAS28-ESR score values at Part-2 Baseline, end of Month 12, and at least 2 intermediate time points. The DAS28-ESR area under the curve was then averaged over the total duration (months) and expressed as units on a scale."|End of Month 6, End of Month 12|8 participants (3 poor quality data, 4 without a post-baseline DAS28-ESR, and 1 did not take Part 2 medication) and 7 participants (5 poor data quality, 1 without a DAS28-ESR at baseline, 1 without post-baseline DAS28-ESR) were excluded from the efficacy evaluable population for the IV-GLM 2mg/kg + SC GLM 50 mg and SC-GLM50 arms, respectively.||Units on a Scale||Standard Deviation|Mean
802350|NCT00975130|Secondary|Number of Participants With a Participant Acceptable Symptom State (PASS) at Month 4, Month 6, and Month 8|The number of participants achieving PASS was evaluated at study Month 2, Month 4, and Month 6 was calculated. PASS is participant self-evaluation tool that uses a VAS 0mm (best) - 100mm (worst), with a score <=31 representing an acceptable PASS.|Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR.||Participants|||Number
802351|NCT00975130|Secondary|Mean Change From Baseline in EQ-5D by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant indicates their health state by ticking the box against the most appropriate statement. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Units on a Scale||Standard Deviation|Mean
802352|NCT00975130|Secondary|Mean Change From Baseline in EQ-5D by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6|The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Units on a Scale||Standard Deviation|Mean
802353|NCT00975130|Secondary|Mean Change From Baseline in EQ-5D by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6|The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802354|NCT00975130|Secondary|Mean Change From Baseline in EQ-5D by Physician Experience Level at Month 2, Month 4, and Month 6|The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802361|NCT00975130|Secondary|Mean Change From Baseline in EQ-5D by Duration of Disease at Month 2, Month 4, and Month 6|The mean change from baseline in the EQ-5D by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802355|NCT00975130|Secondary|Mean Change From Baseline in EQ-5D by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The mean change from baseline in the EQ-5D by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. Participants were grouped by participant expectation score into 3 groups: <=1.5, >1.5 to <1.86, and >=1.86.||Score on a Scale||Standard Deviation|Mean
802356|NCT00975130|Secondary|Mean Change From Baseline in EQ-5D by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the EQ-5D by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802357|NCT00975130|Secondary|Mean Change From Baseline in EQ-5D by Smoking Status at Month 2, Month 4, and Month 6|The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802358|NCT00975130|Secondary|Mean Change From Baseline in EQ-5D by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6|The mean change from baseline in the EQ-5D by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802359|NCT00975130|Secondary|Mean Change From Baseline in EQ-5D by Baseline RF Level at Month 2, Month 4, and Month 6|The mean change from baseline in the EQ-5D by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802360|NCT00975130|Secondary|Mean Change From Baseline in EQ-5D by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6|The mean change from baseline in the EQ-5D by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 to < =5.1 = low disease activity, and DAS28-ESR <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802469|NCT00975130|Secondary|Mean Change From Baseline in ESR by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum ESR by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 to < =5.1 = low disease activity, and DAS28-ESR <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||mm/h||Standard Deviation|Mean
802362|NCT00975130|Secondary|Mean Change From Baseline in EQ-5D by the Number of DMARD Failures at Month 2, Month 4, and Month 6|The mean change from baseline in the EQ-5D by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802363|NCT00975130|Secondary|Mean Change From Baseline in EQ-5D by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the EQ-5D by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802364|NCT00975130|Secondary|Mean Change From Baseline in EQ-5D by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6|The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. DMARD Combination 1=MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2=MTX + leflunomide; Combination 3=MTX +sulfasalazine; Combination 4=MTX + hydrochloroquine, chloroquine, chloroquine phosphate+sulfasalazine; Combination 5=leflunomide.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802365|NCT00975130|Secondary|Mean Change From Baseline in the EuroQOL (EQ-5D) Quality-of-Life Questionnaire by Concomitant MTX Dose at Month 2, Month 4, and Month 6|Concomitant MTX dose was defined as low < 10mg/wk, medium >= 10 to < 15 mg/week, and and high >=15 mg/week. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802366|NCT00975130|Secondary|Number of Participants Who Achieved Minimal or Absence of Functional Impairment|The number of participants that achieved minimal or absence of functional impairment as assessed by the HAQ at study Month 2, Month 4, and Month 6 was calculated. Minimal or absence of functional impairment was defined as a HAQ score of <=0.5. The HAQ evaluates participants on a scale of 0 to 3, with 0=with no difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do.|Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR.||Participants|||Number
802367|NCT00975130|Secondary|Mean Change From Baseline in HAQ-DI by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Units on a Scale||Standard Deviation|Mean
802368|NCT00975130|Secondary|Mean Change From Baseline in HAQ-DI by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6|The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a scores ranging from 0 (best) to 3 (best) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Units on a Scale||Standard Deviation|Mean
802539|NCT00975195|Secondary|Change in On-treatment BODE Index|Change from baseline in on-treatment BODE index (Body mass index, airflow Obstruction, Dyspnea and Exercise capacity index), a composite score ranging from 0 (best) to 10 (worst); change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.|Baseline and week 18 and 52 visits|Treated set||units on a scale||Standard Error|Least Squares Mean
802370|NCT00975130|Secondary|Mean Change From Baseline in HAQ-DI by Physician Experience Level at Month 2, Month 4, and Month 6|The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802371|NCT00975130|Secondary|Mean Change From Baseline in HAQ-DI by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The mean change from baseline in the HAQ-DI by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. Participants were grouped by participant expectation score into 3 groups: <=1.5, >1.5 to <1.86, and >=1.86.||Score on a Scale||Standard Deviation|Mean
802372|NCT00975130|Secondary|Mean Change From Baseline in HAQ-DI by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the HAQ-DI by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802373|NCT00975130|Secondary|Mean Change From Baseline in HAQ-DI by Smoking Status at Month 2, Month 4, and Month 6|The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802374|NCT00975130|Secondary|Mean Change From Baseline in HAQ-DI by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6|The mean change from baseline in the HAQ-DI by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802375|NCT00975130|Secondary|Mean Change From Baseline in HAQ-DI by Baseline RF Level at Month 2, Month 4, and Month 6|The mean change from baseline in the HAQ-DI by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802376|NCT00975130|Secondary|Mean Change From Baseline in HAQ-DI by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6|The mean change from baseline in the HAQ-DI by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 to < =5.1 = low disease activity, and DAS28-ESR <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802377|NCT00975130|Secondary|Mean Change From Baseline in HAQ-DI by Duration of Disease at Month 2, Month 4, and Month 6|The mean change from baseline in the HAQ-DI by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802678|NCT00983385|Secondary|Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol, at End of the Maintenance Period.|Participants were requested to rate their tapentadol (new) analgesic medication on a 5-point scale. The medication was rated as excellent, very good, good, fair and poor.|End of Week 12|Intention to treat (ITT).||participants|||Number
802378|NCT00975130|Secondary|Mean Change From Baseline in HAQ-DI by the Number of DMARD Failures at Month 2, Month 4, and Month 6|The mean change from baseline in the HAQ-DI by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802379|NCT00975130|Secondary|Mean Change From Baseline in HAQ-DI by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the HAQ-DI by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802380|NCT00975130|Secondary|Mean Change From Baseline in HAQ-DI by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6|The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802381|NCT00975130|Secondary|Mean Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ-DI) by Concomitant MTX Dose at Month 2, Month 4, and Month 6|The mean change from baseline the disability index of the HAQ was calculated by concomitant MTX dose (low < 10mg/wk, medium >= 10 to < 15 mg/week, and high >=15 mg/week) at study Month 2, Month 4, and Month 6. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst)with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802382|NCT00975130|Secondary|Number of Participants Achieving Low Disease Activity and Remission at Month 2, Month 4, and Month 6|The number of participants achieving low disease activity or remission was calculated by the DAS28-ESR, DAS28-CRP, and SDAI at study Month 2, Month 4, and Month 6. Low disease activity by DAS28-ESR was defined as >= 2.6 to 3.2, and remission was defined as a DAS28-ESR <2.6. Low disease activity by DAS28-CRP was defined as DAS28-CRP >=2.6 to 3.2, and remission was defined as DAS28-CRP >2.6. Low disease activity by SDAI was defined as SDAI >5.0 to <=20, and remission was defined as SDAI <=5.0.|Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR.||Participants|||Number
802383|NCT00975130|Secondary|Number of Participants Who Achieved DAS28-CRP EULAR Response|DAS28-CRP EULAR response is defined as a good or moderate response that results in a DAS28-CRP >=0.6.|Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR.||Participants|||Number
802384|NCT00975130|Secondary|Number of Participants Who Achieved DAS28-ESR EULAR Response|EULAR response was assessed at the end of Month 2, Month 4, and Month 6 by the Disease Activity Score using the 28 tender and swollen joint count calculated with erythrocyte sedimentation rate values (DAS28-ESR). A good response would was defined as a decrease >1.2 units and a final DAS28-ESR < 3.2 units, while a moderate response was defined as a decrease > 1.2 units and final DAS28-ESR >= 3.2 units, OR a decrease of 0.6 to 1.2.|Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Participants|||Number
802385|NCT00975130|Secondary|Mean Change From Baseline in SDAI by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] – 10 cm [worst]) and level of C‐reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802435|NCT00975130|Secondary|Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the physician global assessment of disease activity by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802386|NCT00975130|Secondary|Mean Change From Baseline in SDAI by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6|The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] – 10 cm [worst]) and level of C‐reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802387|NCT00975130|Secondary|Mean Change From Baseline in SDAI by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6|The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] – 10 cm [worst]) and level of C‐reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802388|NCT00975130|Secondary|Mean Change From Baseline in SDAI by Physician Experience Level at Month 2, Month 4, and Month 6|The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] – 10 cm [worst]) and level of C‐reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802389|NCT00975130|Secondary|Mean Change From Baseline in SDAI by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The mean change from baseline in the SDAI by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] – 10 cm [worst]) and level of C‐reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. Participants were grouped by participant expectation score into 3 groups: <=1.5, >1.5 to <1.86, and >=1.86.||Score on a Scale||Standard Deviation|Mean
802390|NCT00975130|Secondary|Mean Change From Baseline in SDAI by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the SDAI by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6. The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] – 10 cm [worst]) and level of C‐reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802391|NCT00975130|Secondary|Mean Change From Baseline in SDAI by Smoking Status at Month 2, Month 4, and Month 6|The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] – 10 cm [worst]) and level of C‐reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802392|NCT00975130|Secondary|Mean Change From Baseline in SDAI by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6|The mean change from baseline in the SDAI by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6. The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] – 10 cm [worst]) and level of C‐reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802455|NCT00975130|Secondary|Mean Change From Baseline in CRP by Duration of Disease at Month 2, Month 4, and Month 6|The mean change from baseline in the participant serum CRP by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||mg/L||Standard Deviation|Mean
802393|NCT00975130|Secondary|Mean Change From Baseline in SDAI by Baseline RF Level at Month 2, Month 4, and Month 6|The mean change from baseline in the SDAI by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6. The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] – 10 cm [worst]) and level of C‐reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802394|NCT00975130|Secondary|Mean Change From Baseline in SDAI by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6|The mean change from baseline in the SDAI by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. The SDAI is the numerical sum of five outcome parameters: tender and swollen joint count (based on a 28‐joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] – 10 cm [worst]) and level of C‐reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease with increasing scores indicating increased burden of disease. DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 to < =5.1 = low disease activity, and DAS28-ESR <2.6 = remission. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802395|NCT00975130|Secondary|Mean Change From Baseline in SDAI by Duration of Disease at Month 2, Month 4, and Month 6|The mean change from baseline in the SDAI by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. The SDAI is the numerical sum of five outcome parameters: tender and swollen joint count (based on a 28‐joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] – 10 cm [worst]) and level of C‐reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802396|NCT00975130|Secondary|Mean Change From Baseline in SDAI by the Number of DMARD Failures at Month 2, Month 4, and Month 6|The mean change from baseline in the SDAI by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6. The SDAI is the numerical sum of five outcome parameters: tender and swollen joint count (based on a 28‐joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] – 10 cm [worst]) and level of C‐reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802397|NCT00975130|Secondary|Mean Change From Baseline in SDAI by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the SDAI by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6. The SDAI is the numerical sum of five outcome parameters: tender and swollen joint count (based on a 28‐joint assessment), patient and physician global assessment of disease activity (VAS 0 cm [best] – 10 cm [worst]) and level of C‐reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802398|NCT00975130|Secondary|Mean Change From Baseline in SDAI Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6|The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] – 10 cm [worst]) and level of C‐reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802399|NCT00975130|Secondary|Mean Change From Baseline in the Simplified Disease Activity Index (SDAI) Score by Concomitant MTX Dose at Month 2, Month 4, and Month 6|The mean change from baseline in the SDAI was calculated by concomitant MTX dose (low < 10mg/wk, medium >= 10 to < 15 mg/week, and high >=15 mg/week) at study Month 2, Month 4, and Month 6. The SDAI is the numerical sum of five outcome parameters: tender and swollen joint count (based on a 28‐joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] – 10cm [worst]) and level of C-reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802679|NCT00983385|Secondary|Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol, in the Maintenance Period.|Participants were requested to rate their tapentadol (new) analgesic medication on a 5-point scale. The medication was rated as excellent, very good, good, fair and poor.|End of Week 8|Intention to treat (ITT).||participants|||Number
802400|NCT00975130|Secondary|Mean Change From Baseline in DAS28-CRP by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission. The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802401|NCT00975130|Secondary|Mean Change From Baseline in DAS28-CRP Score by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6|The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission. The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Units on a Scale||Standard Deviation|Mean
802402|NCT00975130|Secondary|Mean Change From Baseline in DAS28-CRP Score by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6|The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802403|NCT00975130|Secondary|Mean Change From Baseline in DAS28-CRP Score by Physician Experience Level at Month 2, Month 4, and Month 6|The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission. Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802404|NCT00975130|Secondary|Mean Change From Baseline in DAS28-CRP Score by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-CRP score by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. Participants were grouped by participant expectation score into 3 groups: <=1.5, >1.5 to <1.86, and >=1.86.||Score on a Scale||Standard Deviation|Mean
802405|NCT00975130|Secondary|Mean Change From Baseline in DAS28-CRP Score by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-CRP score by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802406|NCT00975130|Secondary|Mean Change From Baseline in DAS28-CRP Score by Smoking Status at Month 2, Month 4, and Month 6|The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
803920|NCT00986856|Secondary|Number of Patients With Clinical Success at Visit 2||Visit 2: Day 4|The full analysis set consists of 56 patients, 40 patients in the Fucidin® cream 20 mg/g group and 16 patients in the Fucidin® cream vehicle group (2 patients excluded because of lack of efficacy data)||Participants|||Number
802407|NCT00975130|Secondary|Mean Change From Baseline in DAS28-CRP Score by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-CRP score by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802408|NCT00975130|Secondary|Mean Change From Baseline in DAS28-CRP Score by Baseline RF Level at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-CRP by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802409|NCT00975130|Secondary|Mean Change From Baseline in DAS28-CRP Score by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-CRP score by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP with increasing scores indicating increased burden of disease. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). DAS28-CRP > 5.1 = high disease activity, DAS28-CRP < 3.2 to < =5.1 = low disease activity, and DAS28-CRP <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802410|NCT00975130|Secondary|Mean Change From Baseline in DAS28-CRP Score by Duration of Disease at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-CRP score by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802411|NCT00975130|Secondary|Mean Change From Baseline in DAS28-CRP Score by the Number of DMARD Failures at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-CRP score by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802412|NCT00975130|Secondary|Mean Change From Baseline in DAS28-CRP by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-CRP by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802413|NCT00975130|Secondary|Mean Change From Baseline in DAS28-CRP Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6|The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts & swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP >5.1 =high disease activity, DAS28-CRP <3.2=low disease activity, and DAS28-CRP <2.6=remission. DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 =leflunomide.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802540|NCT00975195|Secondary|Change in On-treatment Exercise Capacity Measured by Six-minute Walk Test (6-MWT)|Change from baseline in on-treatment exercise capacity measured by six-minute walk test (6-MWT); change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.|Baseline and week 18 and 52 visits|Treated set||meters||Standard Error|Least Squares Mean
802414|NCT00975130|Secondary|Mean Change From Baseline in DAS28-CRP Score by Concomitant MTX Dose at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-CRP was calculated by concomitant MTX dose (low < 10mg/wk, medium >= 10 to < 15 mg/week, and high >=15 mg/week) at study Month 2, Month 4, and Month 6. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802415|NCT00975130|Secondary|Mean Change From Baseline in DAS28-ESR by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission. The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802416|NCT00975130|Secondary|Mean Change From Baseline in DAS28-ESR Score by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6|The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission. The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802417|NCT00975130|Secondary|Mean Change From Baseline in DAS28-ESR Score by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6|The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802418|NCT00975130|Secondary|Mean Change From Baseline in DAS28-ESR Score by Physician Experience Level at Month 2, Month 4, and Month 6|The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission. Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802419|NCT00975130|Secondary|Mean Change From Baseline in DAS28-ESR Score by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-ESR score by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. Participants were grouped by participant expectation score into 3 groups: <=1.5, >1.5 to <1.86, and >=1.86.||Score on a Scale||Standard Deviation|Mean
802420|NCT00975130|Secondary|Mean Change From Baseline in DAS28-ESR Score by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-ESR score by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
810873|NCT01056315|Secondary|Change From Baseline in the Mean of the Daily Average Pain Intensity Scores (on an 11-point NRS) Over Each Week of Maintenance.||Baseline; daily scores over each week of maintenance||||||
802421|NCT00975130|Secondary|Mean Change From Baseline in DAS28-ESR Score by Smoking Status at Month 2, Month 4, and Month 6|The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802422|NCT00975130|Secondary|Mean Change From Baseline in DAS28-ESR Score by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-ESR score by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. Increasing scores indicate increased burden of disease. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802423|NCT00975130|Secondary|Mean Change From Baseline in DAS28-ESR Score by Baseline RF Level at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-ESR by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. Increasing scores indicate increased burden of disease. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802424|NCT00975130|Secondary|Mean Change From Baseline in DAS28-ESR Score by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-ESR score by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR with increasing scores indicating increased level of disease burden. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 to < =5.1 = low disease activity, and DAS28-ESR <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802425|NCT00975130|Secondary|Mean Change From Baseline in DAS28-ESR Score by Duration of Disease at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-ESR score by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed on a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR >5.1 = high disease activity, DAS28-ESR <3.2 = low disease activity, and DAS28-ESR <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802426|NCT00975130|Secondary|Mean Change From Baseline in DAS28-ESR Score by the Number of DMARD Failures at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-ESR score by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed on a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802427|NCT00975130|Secondary|Mean Change From Baseline in DAS28-ESR by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-ESR by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR <3.2 = low disease activity, and DAS28-ESR <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802456|NCT00975130|Secondary|Mean Change From Baseline in CRP by the Number of DMARD Failures at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum CRP by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||mg/L||Standard Deviation|Mean
802428|NCT00975130|Secondary|Mean Change From Baseline in DAS28-ESR Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6|The DAS28-ESR measures disease burden using patient global health (self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission. DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX+sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802429|NCT00975130|Secondary|Mean Change From Baseline in DAS28-ESR Score by Concomitant MTX Dose at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-ESR was calculated by concomitant MTX dose (low < 10mg/wk, medium >= 10 to < 15 mg/week, and high >=15 mg/week) at study Month 2, Month 4, and Month 6. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802430|NCT00975130|Secondary|Mean Change From Baseline in the Physician Global Assessment of Disease Activity by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The mean change from baseline in the physician global assessment of disease activity by the baseline physician expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Units on a Scale||Standard Deviation|Mean
802431|NCT00975130|Secondary|Mean Change From Baseline in the Physician Global Assessment of Disease Activity by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6|The mean change from baseline in the physician global assessment of disease activity by the number of patients treated with biologics by the treating physician was evaluated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Units on a Scale||Standard Deviation|Mean
802432|NCT00975130|Secondary|Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6|The mean change from baseline in the physician global assessment of disease activity by physician experience level with biologics was evaluated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802433|NCT00975130|Secondary|Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Physician Experience Level at Month 2, Month 4, and Month 6|The mean change from baseline in the physician global assessment of disease activity by the treating physician level of experience was evaluated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802434|NCT00975130|Secondary|Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The mean change from baseline in the physician global assessment of disease activity by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] -100mm [worst]) with increasing scores indicating increased level of disease. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. Participants were grouped by participant expectation score into 3 groups: <=1.5, >1.5 to <1.86, and >=1.86.||Score on a Scale||Standard Deviation|Mean
802541|NCT00975195|Secondary|Change in On-treatment Physical Health Status as Determined by Body Mass Index (BMI)|Change from baseline in on-treatment physical health status as determined by body mass index (BMI); change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.|Baseline and week 18 and 52 visits|Treated set||kg/m2||Standard Error|Least Squares Mean
802436|NCT00975130|Secondary|Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Smoking Status at Month 2, Month 4, and Month 6|The mean change from baseline in the physician global assessment of disease activity by participant baseline smoking status was calculated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802437|NCT00975130|Secondary|Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6|The mean change from baseline in the physician global assessment of disease activity by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR or at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802438|NCT00975130|Secondary|Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Baseline RF Level at Month 2, Month 4, and Month 6|The mean change from baseline in the physician global assessment of disease activity by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802439|NCT00975130|Secondary|Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6|The mean change from baseline in the physician global assessment of disease activity by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802440|NCT00975130|Secondary|Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Duration of Disease at Month 2, Month 4, and Month 6|The mean change from baseline in the physician global assessment of disease activity by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802441|NCT00975130|Secondary|Mean Change From Baseline in the Physician Global Assessment of Disease Activity Score by the Number of DMARD Failures at Month 2, Month 4, and Month 6|The mean change from baseline in the physician global assessment of disease activity score by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802442|NCT00975130|Secondary|Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the physician global assessment of disease activity by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802443|NCT00975130|Secondary|Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the physician global assessment of disease by concomitant DMARD background treatment was evaluated at Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide only.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802457|NCT00975130|Secondary|Mean Change From Baseline in CRP by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in serum CRP by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||mg/L||Standard Deviation|Mean
802444|NCT00975130|Secondary|Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Concomitant MTX Dose at Month 2, Month 4, and Month 6|The mean change from baseline in physician global assessment of disease activity was calculated by concomitant MTX dose (low < 10mg/wk, medium >= 10 to < 15 mg/week, and high >=15 mg/week) at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802445|NCT00975130|Secondary|Mean Change From Baseline in CRP by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum CRP by the physician's expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||mg/L||Standard Deviation|Mean
802446|NCT00975130|Secondary|Mean Change From Baseline in CRP by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum CRP by the number of patients treated with biologics by the treating physician was evaluated at study Month 2, Month 4, and Month 6. The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||mg/L||Standard Deviation|Mean
802447|NCT00975130|Secondary|Mean Change From Baseline in CRP by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum CRP by physician experience level with biologics was evaluated at study Month 2, Month 4, and Month 6. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||mg/L||Standard Deviation|Mean
802448|NCT00975130|Secondary|Mean Change From Baseline in CRP by Physician Experience Level at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum CRP by the treating physician level of experience was evaluated at study Month 2, Month 4, and Month 6. Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||mg/L||Standard Deviation|Mean
802449|NCT00975130|Secondary|Mean Change From Baseline in CRP by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum CRP by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. Participants were grouped by participant expectation score into 3 groups: <=1.5, >1.5 to <1.86, and >=1.86.||mg/L||Standard Deviation|Mean
802450|NCT00975130|Secondary|Mean Change From Baseline in CRP by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum CRP by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||mg/L||Standard Deviation|Mean
802451|NCT00975130|Secondary|Mean Change From Baseline in CRP by Smoking Status at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum CRP by participant baseline smoking status was calculated at study Month 2, Month 4, and Month 6. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||mg/L||Standard Deviation|Mean
802452|NCT00975130|Secondary|Mean Change From Baseline in CRP by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6|The mean change from baseline in CRP by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||mg/L||Standard Deviation|Mean
802453|NCT00975130|Secondary|Mean Change From Baseline in CRP by Baseline RF Level at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum CRP by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||mg/L||Standard Deviation|Mean
802454|NCT00975130|Secondary|Mean Change From Baseline in CRP by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum CRP by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. DAS28-ESR scores of > 3.2 to <=5.1 indicate moderate disease activity and DAS28-ESR scores of > 5.1 indicate high disease activity.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||mg/L||Standard Deviation|Mean
802458|NCT00975130|Secondary|Mean Change From Baseline in CRP by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum CRP by concomitant DMARD background treatment was calculated at study Month 2, Month 4, and Month 6. DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide only.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||mg/L||Standard Deviation|Mean
802459|NCT00975130|Secondary|Mean Change From Baseline in C-Reactive Protein (CRP) by Concomitant MTX Dose at Month 2, Month 4, and Month 6|The change from baseline in participant serum CRP was calculated by concomitant MTX dose (low < 10mg/wk, medium >= 10 to < 15 mg/week, and high >=15 mg/week) at study Month 2, Month 4, and Month 6.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||mg/L||Standard Deviation|Mean
802460|NCT00975130|Secondary|Mean Change From Baseline in ESR by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum ESR by the physician's expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||mm/h||Standard Deviation|Mean
802461|NCT00975130|Secondary|Mean Change From Baseline in ESR by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum ESR by the number of patients treated with biologics by the treating physician was evaluated at study Month 2, Month 4, and Month 6. The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||mm/h||Standard Deviation|Mean
802462|NCT00975130|Secondary|Mean Change From Baseline in ESR by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum ESR by physician experience level with biologics was evaluated at study Month 2, Month 4, and Month 6. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||mm/h||Standard Deviation|Mean
802463|NCT00975130|Secondary|Mean Change From Baseline in ESR by Physician Experience Level at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum ESR by the treating physician level of experience was evaluated at study Month 2, Month 4, and Month 6. Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||mm/h||Standard Deviation|Mean
802464|NCT00975130|Secondary|Mean Change From Baseline in ESR by Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum ESR by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. Participants were grouped by participant expectation score into 3 groups: <=1.5, >1.5 to <1.86, and >=1.86.||mm/h||Standard Deviation|Mean
802465|NCT00975130|Secondary|Mean Change From Baseline in ESR by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum ESR by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||mm/h||Standard Deviation|Mean
802466|NCT00975130|Secondary|Mean Change From Baseline in ESR by Smoking History at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum ESR by participant baseline smoking status was calculated at study Month 2, Month 4, and Month 6. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||mm/h||Standard Deviation|Mean
802467|NCT00975130|Secondary|Mean Change From Baseline in ESR by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6|The mean change from baseline in ESR by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||mm/h||Standard Deviation|Mean
802468|NCT00975130|Secondary|Mean Change From Baseline in ESR by Baseline RF Level at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum ESR by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||mm/h||Standard Deviation|Mean
802470|NCT00975130|Secondary|Mean Change From Baseline in ESR by Duration of Disease at Month 2, Month 4, and Month 6|The mean change from baseline in the participant serum ESR by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||mm/h||Standard Deviation|Mean
802471|NCT00975130|Secondary|Mean Change From Baseline in ESR by the Number of DMARD Failures at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum ESR by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||mm/h||Standard Deviation|Mean
802472|NCT00975130|Secondary|Mean Change From Baseline in ESR by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in serum ESR by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||mm/h||Standard Deviation|Mean
802473|NCT00975130|Secondary|Mean Change From Baseline in ESR by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum ESR by concomitant DMARD background treatment was calculated at study Month 2, Month 4, and Month 6. DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide only.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||mm/h||Standard Deviation|Mean
802474|NCT00975130|Secondary|Mean Change From Baseline in the Erythrocyte Sedimentation Rate (ESR) by Concomitant MTX Dose at Month 2, Month 4, and Month 6|The change from baseline in participant serum ESR was calculated by concomitant MTX dose (low < 10mg/wk, medium >= 10 to < 15 mg/week, and high >=15 mg/week) at study Month 2, Month 4, and Month 6.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||mm/h||Standard Deviation|Mean
802475|NCT00975130|Secondary|Mean Change From Baseline in Participant Global Assessment of Disease Activity by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The mean change from baseline in the participant global assessment of disease activity by the physician's expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] – 100mm [worst]) with increasing scores indicating increased level of disease. The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802476|NCT00975130|Secondary|Mean Change From Baseline in Participant Global Assessment of Disease Activity by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6|The mean change from baseline in the participant global assessment of disease activity by the number of patients treated with biologics by the treating physician was evaluated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] – 100mm [worst]) with increasing scores indicating increased level of disease. The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802477|NCT00975130|Secondary|mm [Best]Mean Change From Baseline in Participant Global Assessment of Disease Activity by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6|The mean change from baseline in the participant global assessment of disease activity by physician experience level with biologics was evaluated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] – 100mm [worst]) with increasing scores indicating increased level of disease. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802478|NCT00975130|Secondary|Mean Change From Baseline in Participant Global Assessment of Disease Activity by Physician Experience Level at Month 2, Month 4, and Month 6|The mean change from baseline in the participant global assessment of disease activity by the treating physician level of experience was evaluated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] – 100mm [worst]) with increasing scores indicating increased level of disease. Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802618|NCT00975923|Secondary|Access of Tools and Use of Quality Improvement Strategies|Follow-up survey of ICU nurse and quality managers for all participating medical centers from Jan 2008 through April 2008 included questions about the implementation of process interventions: Access and use of clinical guidelines tools, access and use of quality improvement tools, and types of quality improvement implementation strategies.|18 months|per protocol||Percentage of ICUs|||Number
802479|NCT00975130|Secondary|Mean Change From Baseline in Participant Global Assessment of Disease Activity by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The mean change from baseline in the participant global assessment of disease activity by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] – 100mm [worst]) with increasing scores indicating increased level of disease. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. Participants were grouped by participant expectation score into 3 groups: <=1.5, >1.5 to <1.86, and >=1.86.||Score on a Scale||Standard Deviation|Mean
802480|NCT00975130|Secondary|Mean Change From Baseline in Participant Global Assessment of Disease Activity by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the participant global assessment of disease activity by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] – 100mm [worst]) with increasing scores indicating increased level of disease.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802481|NCT00975130|Secondary|Mean Change From Baseline in Participant Global Assessment of Disease Activity by Smoking Status at Month 2, Month 4, and Month 6|The mean change from baseline in the participant global assessment of disease activity by participant baseline smoking status was calculated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] – 100mm [worst]) with increasing scores indicating increased level of disease. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802482|NCT00975130|Secondary|Mean Change From Baseline in Participant Global Assessment of Disease Activity by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6|The mean change from baseline in the participant global assessment of disease activity by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] – 100mm [worst]) with increasing scores indicating increased level of disease.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802483|NCT00975130|Secondary|Mean Change From Baseline in Participant Global Assessment of Disease Activity by Baseline RF Level at Month 2, Month 4, and Month 6|The mean change from baseline in the participant global assessment of disease activity by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] – 100mm [worst]) with increasing scores indicating increased level of disease.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802484|NCT00975130|Secondary|Mean Change From Baseline in Participant Global Assessment of Disease Activity by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6|The mean change from baseline in the participant global assessment of disease activity by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] – 100mm [worst]) with increasing scores indicating increased level of disease.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802485|NCT00975130|Secondary|Mean Change From Baseline in Participant Global Assessment of Disease Activity by Duration of Disease at Month 2, Month 4, and Month 6|The mean change from baseline in the participant global assessment of disease activity by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] – 100mm [worst]) with increasing scores indicating increased level of disease.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802486|NCT00975130|Secondary|Mean Change From Baseline in Participant Global Assessment of Disease Activity Score by the Number of DMARD Failures at Month 2, Month 4, and Month 6|The mean change from baseline in the participant global assessment of disease activity score by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] – 100mm [worst]) with increasing scores indicating increased level of disease.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802496|NCT00975130|Secondary|Mean Change From Baseline in the Number of Tender Joints by Smoking History at Month 2, Month 4, and Month 6|The mean change from baseline in the number of tender joints was calculated by the baseline participant smoking status at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Tender Joints||Standard Deviation|Mean
802487|NCT00975130|Secondary|Mean Change From Baseline in Participant Global Assessment of Disease Activity by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the participant global assessment of disease activity by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] – 100mm [worst]) with increasing scores indicating increased level of disease.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802488|NCT00975130|Secondary|Mean Change From Baseline in Participant Global Assessment of Disease Activity by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6|The participant global assessment of disease activity was evaluated using a VAS (0mm [best] – 100mm [worst]) with increasing scores indicating increased level of disease. DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide only.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802489|NCT00975130|Secondary|Mean Change From Baseline in Participant Global Assessment of Disease Activity by Concomitant MTX Dose at Month 2, Month 4, and Month 6|The mean change from baseline in participant global assessment of disease activity was calculated by concomitant MTX dose (low < 10mg/wk, medium >= 10 to < 15 mg/week, and high >=15 mg/week) at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a visual analogue scale (VAS; 0mm [best] -100mm [worst]) with increasing scores indicating increased level of disease.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
802490|NCT00975130|Secondary|Mean Change From Baseline in the Number of Tender Joints by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The mean change from baseline in the number of tender joints. was calculated by the physician's expectation of treatment outcome at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. The physician's expectation of treatment outcomes was assessed at the start of Month 4 at which time physicians were asked to rate their expectations of treatment outcome in each participant as: high disease activity, moderate disease activity, low disease activity, or remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Tender Joints||Standard Deviation|Mean
802491|NCT00975130|Secondary|Mean Change From Baseline in the Number of Tender Joints by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6|The mean change from baseline in the number of tender joints was calculated by the baseline number of patients the physician treats with biologics at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. The number of patients treated with biologics is defined as the number of patients treated by the physician in the last month with biologics for rheumatoid arthritis.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Tender Joints||Standard Deviation|Mean
802492|NCT00975130|Secondary|Mean Change From Baseline in the Number of Tender Joints by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6|The mean change from baseline in the number of tender joints was calculated by the physician experience level with biologics at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Tender Joints||Standard Deviation|Mean
802493|NCT00975130|Secondary|Mean Change From Baseline in the Number of Tender Joints by Physician Experience Level at Month 2, Month 4, and Month 6|The mean change from baseline in the number of tender joints was calculated by the physician experience level at study Month 2, Month 4, Month 6. A total of 28 joints were evaluated. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Tender Joints||Standard Deviation|Mean
802494|NCT00975130|Secondary|Mean Change From Baseline in the Number of Tender Joints by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The mean change from baseline in the number of tender joints was calculated by the participant baseline expectation of treatment outcome at study Month 2, Month 4, Month 6. A total of 28 joints were evaluated. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. Participants were grouped by participant expectation score into 3 groups: <=1.5, >1.5 to <1.86, and >=1.86.||Tender Joints||Standard Deviation|Mean
802495|NCT00975130|Secondary|Mean Change From Baseline in the Number of Tender Joints by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the number of tender joints was calculated by the baseline participant eligibility for anti-TNF treatment at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Tender Joints||Standard Deviation|Mean
807987|NCT01027910|Primary|Maximum Tolerated Dose||up to 30 days after starting study drugs|The two groups differ in that GCSF was offered if clinically indicated in arm 1 while it was administered to all participants in arm 2.||mg/m2|||Number
802497|NCT00975130|Secondary|Mean Change From Baseline in the Number of Tender Joints by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6|The mean change from baseline in the number of tender joints was calculated by the participant baseline level of anti-CCP at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Tender Joints||Standard Deviation|Mean
802498|NCT00975130|Secondary|Mean Change From Baseline in the Number of Tender Joints by Baseline RF Level at Month 2, Month 4, and Month 6|The change from baseline in the mean number of tender joints was calculated by the participant baseline level of RF at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Tender Joints||Standard Deviation|Mean
802499|NCT00975130|Secondary|Mean Change From Baseline in the Number of Tender Joints by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6|The mean change from baseline in the number of tender joints was calculated by the participant baseline level of disease activity, as measured by DAS28, at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 to < =5.1 = low disease activity, and DAS28-ESR <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Tender Joints||Standard Deviation|Mean
802500|NCT00975130|Secondary|Mean Change From Baseline in the Number of Tender Joints by Duration of Disease at Month 2, Month 4, and Month 6|The mean change from baseline in the number of tender joints was calculated by the participant duration of disease at study Month 2, Month 4, and Month 6. Duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. A total of 28 joints were evaluated.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Tender Joints||Standard Deviation|Mean
802501|NCT00975130|Secondary|Mean Change From Baseline in the Number of Tender Joints by the Number of DMARD Failures at Month 2, Month 4, and Month 6|The mean change from baseline in the number of tender joints was calculated by the number of participant DMARD failures at baseline at study Month 2, Month 4, Month 6. A total of 28 joints were evaluated.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Tender Joints||Standard Deviation|Mean
802502|NCT00975130|Secondary|Mean Change From Baseline in the Number of Tender Joints by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the number of tender joints was calculated by participant baseline concomitant steroid treatment at study Month 2, Month 4, and Month 6. A total 28 joints were evaluated.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Tender Joints||Standard Deviation|Mean
802503|NCT00975130|Secondary|Mean Change From Baseline in the Number of Tender Joints by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the number of tender joints was calculated by participant background DMARD treatment at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide only.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Tender Joints||Standard Deviation|Mean
802504|NCT00975130|Secondary|Mean Change From Baseline in the Number of Tender Joints by Concomitant MTX Dose at Month 2, Month 4, and Month 6|The mean change from baseline in the number of tender joints was calculated by participant concomitant MTX dose (low < 10mg/wk, medium >= 10 to < 15 mg/week, and high >=15 mg/week) at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Tender Joints||Standard Deviation|Mean
802505|NCT00975130|Secondary|Mean Change From Baseline in the Number of Swollen Joints by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The mean change from baseline in the number of swollen joints was calculated by the physician's expectation of treatment outcome at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. The physician's expectation of treatment outcomes was assessed at the start of Month 4 at which time physicians were asked to rate their expectations of treatment outcome in each participant as: high disease activity, moderate disease activity, low disease activity, or remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Swollen Joints||Standard Deviation|Mean
802506|NCT00975130|Secondary|Mean Change From Baseline in the Number of Swollen Joints by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6|The mean change from baseline in the number of swollen joints was calculated by the baseline number of patients the physician treats with biologics at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. The number of patients treated with biologics is defined as the number of patients treated by the physician in the last month with biologics for rheumatoid arthritis.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Swollen Joints||Standard Deviation|Mean
802507|NCT00975130|Secondary|Mean Change From Baseline in the Number of Swollen Joints by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6|The mean change from baseline in the number of swollen joints was calculated by the physician experience level with biologics at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Swollen Joints||Standard Deviation|Mean
802508|NCT00975130|Secondary|Mean Change From Baseline in the Number of Swollen Joints by Physician Experience Level at Month 2, Month 4, and Month 6|The mean change from baseline in the number of swollen joints was calculated by the physician experience level at study Month 2, Month 4, Month 6. A total of 28 joints were evaluated. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Swollen Joints||Standard Deviation|Mean
802509|NCT00975130|Secondary|Mean Change From Baseline in the Number of Swollen Joints by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The mean change from baseline in the number of swollen joints was calculated by the participant baseline expectation of treatment outcome at study Month 2, Month 4, Month 6. A total of 28 joints were evaluated. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. Participants were grouped by participant expectation score into 3 groups: <=1.5, >1.5 to <1.86, and >=1.86.||Swollen Joints||Standard Deviation|Mean
802510|NCT00975130|Secondary|Mean Change From Baseline in the Number of Swollen Joints by Eligibility for Anti-Tumor Necrosis Factor (Anti-TNF) Treatment at Month 2, Month 4, and Month 6|The change from baseline in the mean number of swollen joints was calculated by the baseline participant eligibility for anti-TNF treatment at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Swollen Joints||Standard Deviation|Mean
802511|NCT00975130|Secondary|Mean Change From Baseline in the Number of Swollen Joints by Smoking History at Month 2, Month 4, and Month 6|The change from baseline in the mean number of swollen joints was calculated by the baseline participant smoking status at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Swollen Joints||Standard Deviation|Mean
802512|NCT00975130|Secondary|Mean Change From Baseline in the Number of Swollen Joints by Baseline Anti-Cyclic Citrullinated Antibody (Anti-CCP) Level at Month 2, Month 4, and Month 6|The change from baseline in the mean number of swollen joints was calculated by the participant baseline level of anti-CCP at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Swollen Joints||Standard Deviation|Mean
802513|NCT00975130|Secondary|Mean Change From Baseline in the Number of Swollen Joints by Baseline Rheumatoid Factor (RF) Level at Month 2, Month 4, and Month 6|The change from baseline in the mean number of swollen joints was calculated by the participant baseline level of RF at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Swollen Joints||Standard Deviation|Mean
802514|NCT00975130|Secondary|Mean Change From Baseline in the Number of Swollen Joints by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6|The mean change from baseline in the number of swollen joints by participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6 by the participant's level of baseline disease activity, as measured by DAS28-ESR. A total of 28 joints were evaluated. DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 to < =5.1 = low disease activity, and DAS28-ESR <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Swollen Joints||Standard Deviation|Mean
802515|NCT00975130|Secondary|Mean Change From Baseline in the Number of Swollen Joints by Duration of Disease at Month 2, Month 4, and Month 6|The mean change from baseline in the mean number of swollen joints was calculated by the participant duration of disease at study Month 2, Month 4, and Month 6. The participant duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. A total of 28 joints were evaluated.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Swollen Joints||Standard Deviation|Mean
802516|NCT00975130|Secondary|Mean Change From Baseline in the Number of Swollen Joints by the Number of DMARD Failures at Month 2, Month 4, and Month 6|The mean change from baseline in the mean number of swollen joints by the number of baseline participant DMARD failures was calculated at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Swollen Joints||Standard Deviation|Mean
802985|NCT00988442|Secondary|Change in CD4 Cell Count at Week 12|Change in CD4 cell count from baseline at week 12, calculated as Week 12 CD4 minus baseline CD4.|Baseline and Week 12|Due to early study closure, only 44 participants had week 12 CD4 observations to be included in this analysis.||cells/mm^3||95% Confidence Interval|Mean
802517|NCT00975130|Secondary|Mean Change From Baseline in the Number of Swollen Joints by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the number of swollen joints by participant baseline concomitant corticosteroid treatment was calculated at study Month 2, Month 4, and Month 6 . A total of 28 joints were evaluated.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Swollen Joints||Standard Deviation|Mean
802518|NCT00975130|Secondary|Mean Change From Baseline in the Number of Swollen Joints by Disease Modifying Antirheumatic Drug (DMARD) Background Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the number of swollen joints was calculated by participant baseline background DMARD treatment regimen at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide only.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Swollen Joints||Standard Deviation|Mean
802519|NCT00975130|Secondary|Mean Change From Baseline in the Number of Swollen Joints by Concomitant Methotrexate (MTX) Dose at Month 2, Month 4, and Month 6|The mean change from baseline in the mean number of swollen joints was calculated at study Month 2, Month 4, and Month 6 by concomitant MTX dose (low < 10mg/wk, medium >= 10 to < 15 mg/week, and high >=15 mg/week). A total of 28 joints were evaluated.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Swollen Joints||Standard Deviation|Mean
802520|NCT00975130|Primary|Number of Participants Experiencing Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR) Remission at the Start of Month 11 and End of Month 12|The number of participants experiencing DAS28-ESR remission was evaluated at the start of study Month 11 and the end of study Month 12. The DAS28-ESR is expressed on a unit on a scale with the minimum score=0 (best) to maximum score=10 (worst). Remission was defined as DAS28-ESR <2.6.|Start of Month 11, End of Month 12|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR.||Participants|||Number
802521|NCT00975130|Primary|Number of Participants Achieving a Good or Moderate European League Against Rheumatism (EULAR) Response at Month 6|EULAR response was assessed at the end of Month 6 by the Disease Activity Score using the 28 tender and swollen joint count calculated with erythrocyte sedimentation rate values (DAS28-ESR). A good response was defined as a decrease >1.2 units and a final DAS28-ESR < 3.2 units, while a moderate response was defined as a decrease > 1.2 units and final DAS28-ESR >= 3.2 units, OR a decrease of 0.6 to 1.2 units AND final DAS28-ESR <= 5.1 units|Month 6|The Efficacy Evaluable population in Part 1 of the study excluded participants without a DAS28-ESR at baseline and at least 1 post-line value DAS28-ESR or those that had very poor data quality due to incomplete documentation.||Participants|||Number
802522|NCT00975143|Primary|Co-Primary Outcome 2: Proportion of Patients Who Achieve at Least a 90% Reduction in Total Number of Nodular Lesions (Facial and Truncal).|"The percentage of patients in each group who achieved ≥90% reduction in the total nodular lesion count from Baseline to Week 20 was calculated along with its 95% CI (normal approximation). A 95% 2-sided CI on the difference between treatments (CIP-ISOTRETINOIN minus Isotretinoin) was also computed.
Pre-defined criterion for non-inferiority: lower bound of the 95% CI for the treatment difference > -10."|20 weeks|Analysis based on the Per Protocol (PP) Population, defined as all randomized patients who were at least 75% compliant with their assigned treatment, had no major study protocol violations, had a Week 20 count of total nodular lesions, and did not use any disallowed medications during the 20 study weeks.||percentage of participants||95% Confidence Interval|Number
802523|NCT00975143|Secondary|Proportion of Patients Who Are Rated as Clear/Almost Clear on the Six-point Physicians' Global Assessment Scale (PGSA).|PGSA categories: 1 (Almost clear); 2 (Mild); 3 (Moderate); 4 (Severe); 5 (Very severe). A grade of either 0 (clear) or 1 (almost clear) on the 6-point PGSA scale within the Week 20 analysis window was considered a success.|20 weeks|Analysis based on the Per Protocol (PP) Population. Patients with a Baseline PGSA score of 0 or 1 (i.e., who had primarily truncal lesions at Baseline) were excluded from the analysis, as PGSA evaluated facial lesions.||percentage of participants||95% Confidence Interval|Number
802524|NCT00975143|Primary|Co-primary Outcome 1: Change From Baseline in Total Nodular Lesion Count (Facial and Truncal)|"The change from Baseline to Week 20 in the total number of nodular lesions was calculated as the Week 20 lesion count minus Baseline lesion count and compared using Analysis of Covariance (ANCOVA), controlling for Baseline total nodular lesion count, gender and analysis site.
The 95% CI of the adjusted least square mean difference (CIP-ISOTRETINOIN minus Isotretinoin) was also calculated using the ANCOVA model.
Pre-defined criterion for non-inferiority: upper bound of the 95% CI for the treatment difference < 4."|20 weeks|Analysis based on the Per Protocol (PP) Population, defined as all randomized patients who were at least 75% compliant with their assigned treatment, had no major study protocol violations, had a Week 20 count of total nodular lesions, and did not use any disallowed medications during the 20 study weeks.||Lesions||Standard Deviation|Mean
802525|NCT00975156|Secondary|6 Minute Walking Distance (6MWD)||Baseline, 1-Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention|||meters (m)||Standard Deviation|Mean
802526|NCT00975156|Primary|10-meter Walking Test (10mWT)||Baseline, 1 Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention|Analysis was determined per protocol (i.e.between-group variation)||meters per second (m/s)||Standard Deviation|Mean
802527|NCT00975195|Secondary|Change in On-treatment Physician Global Evaluation|"Change from baseline in on-treatment physician global evaluation. The evaluation reflected the physician's opinion of the patient's overall condition and was based on the need for concomitant medication, the number and severity of exacerbations, the severity of cough, the ability to exercise, the amount of wheezing and any other relevant clinical observations. Patients were graded on a scale of 1 (poor) to 8 (excellent). Change was calculated as week score minus baseline score.
Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest."|Baseline and week 27 and 52 visits|Treated set||units on a scale||Standard Error|Least Squares Mean
802528|NCT00975195|Secondary|Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Total Score|"Change from baseline in on-treatment St Georges Respiratory Questionnaire (SGRQ) scores: Total score. Scores range from 0 to 100, with higher scores indicating more limitations. Change was calculated as week score minus baseline score.
Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest."|Baseline and week 27 and 52 visits|Treated set||units on a scale||Standard Error|Least Squares Mean
802529|NCT00975195|Secondary|Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Symptoms Domain|"Change from baseline in on-treatment St Georges Respiratory Questionnaire (SGRQ) scores: Symptoms domain. Scores range from 0 to 100, with higher scores indicating more limitations. Change was calculated as week score minus baseline score.
Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest."|Baseline and week 27 and 52 visits|Treated set||units on a scale||Standard Error|Least Squares Mean
802530|NCT00975195|Secondary|Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Impact Domain|"Change from baseline in on-treatment St Georges Respiratory Questionnaire (SGRQ) scores: Impact Domain. Scores range from 0 to 100, with higher scores indicating more limitations. Change was calculated as week score minus baseline score.
Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest."|Baseline and week 27 and 52 visits|Treated set||units on a scale||Standard Error|Least Squares Mean
802531|NCT00975195|Secondary|Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Activity Domain|"Change from baseline in on-treatment St Georges Respiratory Questionnaire (SGRQ) scores: Activity domain. Scores range from 0 to 100, with higher scores indicating more limitations. Change was calculated as week score minus baseline score.
Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest."|Baseline and week 27 and 52 visits|Treated set||units on a scale||Standard Error|Least Squares Mean
802532|NCT00975195|Secondary|Change in On-treatment PEFR as Measured by Home Based Spirometry|Change from baseline in on-treatment peak expiratory flow rate (PEFR) as measured by home based spirometry; change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.|Baseline and week 6, 12, 18, 27, 36, 45 and 52 visits|Treated set||Litres/sec||Standard Error|Least Squares Mean
802533|NCT00975195|Secondary|Change in On-treatment FVC as Measured by Home Based Spirometry|Change from baseline in on-treatment forced vital capacity (FVC) as measured by home based spirometry. Change was calculated as week score minus baseline score. The weekly mean was defined as the mean of the measurements taken during the last 7 days prior to the visit date, and was calculated if ≥4 of the 7 days had non-missing measurements. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.|Baseline and week 6, 12, 18, 27, 36, 45 and 52 visits|Treated set||Litres||Standard Error|Least Squares Mean
802534|NCT00975195|Secondary|Change in On-treatment FEV1 as Measured by Home Based Spirometry|Change from baseline in on-treatment Forced Expiratory Volume in One Second (FEV1) as measured by home based spirometry. Change was calculated as week score minus baseline score. The weekly mean was defined as the mean of the measurements taken during the last 7 days prior to the visit date, and was calculated if ≥4 of the 7 days had non-missing measurements. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.|Baseline and week 6, 12, 18, 27, 36, 45 and 52 visits|Treated set||Litres||Standard Error|Least Squares Mean
802535|NCT00975195|Secondary|Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Sputum Symptoms Domain|"Change from baseline in on-treatment cough and expectoration as measured by the cough and sputum assessment questionnaire (CASA-Q) (selected sites only): Sputum symptoms domain. Change was calculated as week score minus baseline score. Response options for the items in this domain range from “not at all/never” to “extremely/always” on a five-point scale. Domain items were reverse scored, summed and transformed to a domain score ranging from 0 to 100 where a higher score is associated with less symptoms due to sputum.
Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest."|Baseline and week 12, 18 and 52 visits|Treated set who completed CASA-Q||units on a scale||Standard Error|Least Squares Mean
802536|NCT00975195|Secondary|Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Sputum Impact Domain|"Change from baseline in on-treatment cough and expectoration as measured by the cough and sputum assessment questionnaire (CASA-Q) (selected sites only): Sputum impact domain. Change was calculated as week score minus baseline score. Response options for the items in this domain range from “not at all/never” to “a lot/always” on a five-point scale. Domain items were reverse scored, summed and transformed to a domain score ranging from 0 to 100 where a higher score is associated with less impact due to sputum.
Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest."|Baseline and week 12, 18 and 52 visits|Treated set who completed CASA-Q||units on a scale||Standard Error|Least Squares Mean
802537|NCT00975195|Secondary|Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Cough Symptoms Domain|"Change from baseline in on-treatment cough and expectoration as measured by the cough and sputum assessment questionnaire (CASA-Q) (selected sites only): Cough symptoms domain. Change was calculated as week score minus baseline score. Response options for the items in this domain range from “not at all/never” to “a lot/always” on a five-point scale. Domain items were reverse scored, summed and transformed to a domain score ranging from 0 to 100 where a higher score is associated with less symptoms due to cough.
Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest."|Baseline and week 12, 18 and 52 visits|Treated set who completed CASA-Q||units on a scale||Standard Error|Least Squares Mean
802538|NCT00975195|Secondary|Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Cough Impact Domain|"Change from baseline in on-treatment cough and expectoration as measured by the cough and sputum assessment questionnaire (CASA-Q) (selected sites only): Cough impact domain. Change was calculated as week score minus baseline score. Response options for the items in this domain range from “not at all/never” to “extremely/always” on a five-point scale. Domain items were reverse scored, summed and transformed to a domain score ranging from 0 to 100 where a higher score is associated with less impact due to cough.
Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest."|Baseline and week 12, 18 and 52 visits|Treated set who completed CASA-Q||units on a scale||Standard Error|Least Squares Mean
802542|NCT00975195|Secondary|Changes in On-treatment Dyspnoea as Measured by the Modified Medical Research Council (MMRC) Dyspnoea Scale|"Change from baseline in on-treatment dyspnoea as measured by the Modified Medical Research Council (MMRC) dyspnoea scale; change was calculated as week score minus baseline score. Negative changes from baseline indicate an improvement in health.
Scale from 0 to 4:
0 = not troubled by breathlessness, except during strenuous exercise
1 = short of breath when hurrying or walking up a slight hill
2 = walks slower than contemporaries on the same level because of breathlessness, or has to stop for breath when walking at own pace
3 = stops for breath after approximately 100 yards, or after a few minutes on the level
4 = too breathless to leave the house, or breathless when dressing or undressing
No breathlessness was given a score of -1
Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest."|Baseline and week 18 and 52 visits|Treated set||units on a scale||Standard Error|Least Squares Mean
802543|NCT00975195|Secondary|Change in On-treatment Lung Function as Measured by Trough FEV1|Change from baseline in on-treatment lung function as measured by trough forced expiratory volume in one second (FEV1); change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.|Baseline and week 6, 12, 18 and 52 visits|Treated set||Litres||Standard Error|Least Squares Mean
802544|NCT00975195|Secondary|Severity of On-treatment COPD Exacerbations|Severity of on-treatment COPD exacerbations: for each patient, the worst applicable category was taken (i.e. none, mild, moderate or severe)|During randomised treatment, up to 488 days|Treated set||percentage of participants|||Number
802545|NCT00975195|Secondary|Proportion of Patients With at Least One On-treatment COPD Exacerbation|Presence (yes vs no) of at least one on-treatment COPD exacerbation of any severity, displayed as a percentage.|During randomised treatment, up to 488 days|Treated set||percentage of participants|||Number
802546|NCT00975195|Secondary|Number of On-treatment COPD Exacerbations|"Number of on-treatment COPD exacerbations of any severity, based on a 7-day gap rule: exacerbations where the onset date of the second exacerbation event was ≤7 days after the end date of the first exacerbation event were combined.
Measured values show adjusted event rate."|During randomised treatment, up to 488 days|Treated set||exacerbations per patient-year||95% Confidence Interval|Mean
802547|NCT00975195|Secondary|Time to First On-treatment COPD Exacerbation|"Time to first on-treatment COPD exacerbation of any severity. The measure type displays the 25th percentile and its 95% confidence interval."|During randomised treatment, up to 488 days|Treated set||days||95% Confidence Interval|Number
802548|NCT00975195|Secondary|Proportion of Patients With at Least One Severe On-treatment COPD Exacerbation.|Presence (yes vs no) of at least one severe on-treatment COPD exacerbation, displayed as a percentage. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for >6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital.|During randomised treatment, up to 488 days|Treated set||percentage of participants|||Number
802549|NCT00975195|Secondary|Number of Severe On-treatment COPD Exacerbations|"Number of severe on-treatment COPD exacerbations based on a 7-day gap rule: exacerbations where the onset date of the second exacerbation event was ≤7 days after the end date of the first exacerbation event were combined and counted as severe if ≥1 of the contributing exacerbation events was severe. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for >6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital.
Measured values show adjusted event rate."|During randomised treatment, up to 488 days|Treated set||exacerbations per patient-year||95% Confidence Interval|Mean
802550|NCT00975195|Secondary|Time to First Severe On-treatment COPD Exacerbation|"Time to first severe on-treatment COPD exacerbation. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for >6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital.
The measure type displays the 25th percentile and its 95% confidence interval."|During randomised treatment, up to 488 days|Treated set||days||95% Confidence Interval|Number
802551|NCT00975195|Secondary|Proportion of Patients With ≥1 Moderate or Severe On-treatment COPD Exacerbation|Presence (yes vs no) of at least one moderate or severe on-treatment COPD exacerbation, displayed as a percentage. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for >6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital. Exacerbations were considered moderate if they required prescription of antibiotics and/or systemic steroids.|During randomised treatment, up to 488 days|Treated set||percentage of participants|||Number
802552|NCT00975195|Secondary|Number of Moderate or Severe On-treatment COPD Exacerbations|"Number of moderate or severe on-treatment COPD exacerbations, based on a 7-day gap rule: exacerbations where the onset date of the second exacerbation event was ≤7 days after the end date of the first exacerbation event were combined and counted as moderate or severe if ≥1 of the contributing exacerbation events was moderate or severe. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for >6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital. Exacerbations were considered moderate if they required prescription of antibiotics and/or systemic steroids.
Measured values show adjusted mean event rate."|During randomised treatment, up to 488 days|Treated Set||exacerbations per patient-year||95% Confidence Interval|Mean
802562|NCT00975286|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 14 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.||percentage of participants|||Number
802633|NCT00982995|Secondary|To Determine the Partial Response (Relief of Nausea and Vomiting to the Extent That the Patient Desires Continued Dosing With Palonosetron,) in Terminally Ill Patients Suffering From Nausea and/or Vomiting, Treated With Palonosetron||96 hours after dosing|The study was unable to accrue the required number of patients to analyze the primary outcome.|||||
802553|NCT00975195|Primary|Time to First Moderate or Severe On-treatment COPD Exacerbation|"A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as an increase or new onset of ≥2 lower respiratory symptoms related to COPD, with ≥1 symptom lasting ≥3 days, requiring a change in treatment. Lower respiratory symptoms included shortness of breath, sputum production (volume), sputum purulence, cough, wheezing and chest tightness. A change in treatment included: hospitalisation/treatment in an urgent care unit, prescription of antibiotics and/or systemic steroids or a significant change of prescribed respiratory medication such as theophyllines, long-acting beta-agonists or inhaled corticosteroids. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for >6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital.The measure type displays the 25th percentile and its 95% confidence interval."|During randomised treatment, up to 488 days|Treated set||days||95% Confidence Interval|Number
802554|NCT00975221|Secondary|Percent Change From Baseline in Plasma Parathyroid Hormone Level During the EAP||Baseline and the EAP (mean of Weeks 16, 20, 24, and 28)|Full analysis set with at least 1 post-baseline measurement; for participants with no data for the EAP, the last post-baseline value from the titration phase was used to impute the missing EAP values (LVCF imputation).||percent change||Standard Error|Least Squares Mean
802555|NCT00975221|Secondary|Percent Change From Baseline in Corrected Total Serum Calcium Concentration During the EAP||Baseline and the EAP (mean of Weeks 16, 20, 24, and 28)|Full analysis set with at least 1 post-baseline measurement; for participants with no data for the EAP, the last post-baseline value from the titration phase was used to impute the missing EAP values (LVCF imputation).||percent change||Standard Error|Least Squares Mean
802556|NCT00975221|Secondary|Percentage of Participants With a ≥ 1 mg/dL (0.25 mmol/L) Decrease From Baseline in Mean Corrected Total Serum Calcium Concentration During the EAP||Baseline and the EAP (mean of Weeks 16, 20, 24, and 28)|Full analysis set (all participants randomized to treatment). For participants with no data for the EAP, the last post-baseline value from the titration phase was used to impute the missing EAP values (last value carried forward (LVCF) imputation). Participants with only baseline information were counted as non-responders.||percentage of participants|||Number
802557|NCT00975221|Primary|Percentage of Participants With Mean Corrected Total Serum Calcium Concentration ≤ 10.3 mg/dL (2.57 mmol/L) During the EAP||Efficacy assessment phase (study visits at Weeks 16, 20, 24, and 28)|Full analysis set (all participants randomized to treatment). For participants with no data for the EAP, the last post-baseline value from the titration phase was used to impute the missing EAP values (last value carried forward (LVCF) imputation). Participants with only baseline information were counted as non-responders.||percentage of participants|||Number
802558|NCT00975286|Other Pre-specified|Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia|Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the patient required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.|First dose of study drug up to 3 days after the last dose administration|Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.||participants|||Number
802559|NCT00975286|Secondary|Change From Baseline in Treatment Satisfaction Score (Sum of Items 1, 4, 5, 6, 7 and 8 of DTSQ) at Week 24|Change was calculated by subtracting baseline value from Week 24 value. DTSQ: 8-item questionnaire to assess treatment satisfaction and patient perception of hyper and hypoglycemia. Each question (Q) scored on a Likert scale from 0 to 6. Six items (Q1 and 4-8; higher score = more satisfaction) measured treatment satisfaction and were summed to calculate treatment satisfaction score which ranged from 0 (very dissatisfied) to 36 (very satisfied). Two items (Q2 and 3), which were not included, measured perceived hyperglycemia and hypoglycemia, respectively and lower scores represented good perceived blood glucose control. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline DTSQ assessment during on-treatment period. Missing data was imputed using LOCF.||units on a scale||Standard Error|Least Squares Mean
802560|NCT00975286|Secondary|Percentage of Patients Requiring Rescue Therapy During the Double-blind Period|Routine fasting SMPG, central laboratory FPG and HbA1c values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG and HbA1c were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG >200 milligram/deciliter (mg/dL) (11.1 mmol/L) or HbA1c >9%, from Week 8 to Week 24: fasting SMPG/FPG >180 mg/dL (10.0 mmol/L) or HbA1c >8.5%. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline up to Week 24|mITT population.||percentage of participants|||Number
802561|NCT00975286|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 24|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 14 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.||percentage of participants|||Number
802591|NCT00975507|Secondary|Number of Participants With Postvaccination Measles ELISA Antibody Titer ≥207.8 mIU/mL|Antibody Response to Measles at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <207.8 mIU/mL) to Measles at Baseline|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to measles at baseline, and followed protocol procedures.||Participants|||Number
802563|NCT00975286|Other Pre-specified|Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.||percentage of participants|||Number
802564|NCT00975286|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 1 day after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline FPG assessment during on-treatment period. Missing data was imputed using LOCF.||mmol/L||Standard Error|Least Squares Mean
802565|NCT00975286|Secondary|Change From Baseline in Average Insulin Glargine Daily Dose at Week 24|Change was calculated by subtracting the baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline insulin glargine dose assessment during on-treatment period. Missing data was imputed using LOCF.||units per day||Standard Error|Least Squares Mean
802566|NCT00975286|Secondary|Change From Baseline in Body Weight at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period. Missing data was imputed using LOCF.||kilogram||Standard Error|Least Squares Mean
802567|NCT00975286|Secondary|Change From Baseline in Average 7-Point Self Monitored Plasma Glucose (SMPG) Profile at Week 24|Patients recorded a 7-point plasma glucose profile measured before and 2 hours after each meal and at bedtime once in a week and the average value for the 7-time points was calculated. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline average 7-point SMPG assessment during on-treatment period. Missing data was imputed using LOCF.||mmol/L||Standard Error|Least Squares Mean
802568|NCT00975286|Secondary|Change From Baseline in Glucose Excursion at Week 24|Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the standardized meal test, before study drug administration. Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline glucose excursion assessment during on-treatment period. Missing data was imputed using LOCF.||mmol/L||Standard Error|Least Squares Mean
802569|NCT00975286|Secondary|Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Week 24|The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline 2-hour PPG assessment during on-treatment period. Missing data was imputed using last observation carried forward (LOCF).||mmol/L||Standard Error|Least Squares Mean
802570|NCT00975286|Primary|Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|Absolute change = HbA1c value at Week 24 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 14 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population:all randomized patients who received at least 1 dose;had baseline,at least 1 post-baseline efficacy assessment, irrespective of compliance with study protocol/procedures. Number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period. Last observation carried forward used.||percentage of hemoglobin||Standard Error|Least Squares Mean
802571|NCT00975416|Other Pre-specified|Drug Craving|Cocaine Craving Questionnaire|Post-treatment||||||
802572|NCT00975416|Primary|Therapeutic Alliance|"Penn Helping Alliance Questionnaire containing 19 questions with possible scores from 19(low therapeutic alliance)-114(high therapeutic alliance).
Working Alliance Inventory containing 36 questions with possible scores from 36(low therapeutic alliance)-252 (high therapeutic alliance)."|Post 12 weeks treatment with cognitive behavioral therapy|Number of participants for analysis was determined by the number of participants who had post-treatment outcome measures.||units on a scale||Standard Deviation|Mean
802573|NCT00975481|Primary|Other Subjective Effects- Addiction Research Center Inventory (ARCI) Benzedrine Group (BG): Maximum Effect (Emax) and Minimum Effect (Emin)|ARCI (BG) is measure of other subjective effects. It is a set of 13 questions in which each question contributes to total score. Participants select ‘False’ / 'True' for response. One point given for each response that agrees with scoring direction, true items receive score of 1 if answer 'True', false items receive score of 1 if answer 'False'. No points if answer is opposite to scoring direction. Score range: 0 to 13, higher score indicated higher other subjective effects. Emax: largest effect score between 0 - 24 hours post-dose. Emin: smallest effect score between 0 - 24 hours post-dose.|0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose|The pharmacodynamic analysis included all randomized participants in the treatment phase who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter in at least 1 treatment period.||Units on Scale||Standard Deviation|Mean
802574|NCT00975481|Primary|Other Subjective Effects- Drug Similarity|Drug similarity VAS is one of the measures of other subjective effects. It assesses the similarity of the drug recently received by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm= not at all similar) to 'extremely' (score of 100 mm= very similar). Recently received drugs were compared with placebo, benzodiazepines, codeine/morphine, Tetrahydrocannabinol (THC), pseudoephedrine.|12 hours post-dose|The pharmacodynamic analysis included all randomized participants in the treatment phase who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter in at least 1 treatment period. 'n' is signifying those participants who were evaluated for this measure for various drugs for similarity in each treatment group.||mm||Standard Deviation|Mean
802575|NCT00975481|Primary|Other Subjective Effects- Any Drug Effects: Peak Effect (Maximum Effect [Emax])|Any drug effects VAS is one of the measures of other subjective effects. It assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm= definitely not) to 'extremely' (score of 100 mm= definitely so). Emax is the largest effect score between 0.5 to 24 hours post-dose.|0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose|The pharmacodynamic analysis included all randomized participants in the treatment phase who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter in at least 1 treatment period.||mm||Standard Deviation|Mean
802576|NCT00975481|Primary|Sedative Effects- Alertness/Drowsiness: Minimum Effect (Emin)|"Alertness/Drowsiness VAS is one of the measures of sedative effects. It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of neither drowsy nor alert (score of 50 mm), on the left with very drowsy (score of 0 mm) and on the right with very alert (score of 100 mm). Emin is the smallest effect score between 0 to 24 hours post-dose."|0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose|The pharmacodynamic analysis included all randomized participants in the treatment phase who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter in at least 1 treatment period.||mm||Standard Deviation|Mean
802577|NCT00975481|Primary|Sedative Effects- Addiction Research Center Inventory (ARCI) Pentobarbital Chlorpromazine Group (PCAG): Maximum Effect (Emax)|ARCI (PCAG) is one of the measures of sedative effects. It is a set of 15 questions in which each question contributes to total score. Participants indicate their responses by selecting 'False' or 'True'. One point is given for each response that agrees with the scoring direction on scale i.e, true items receive a score of 1 if answer is 'True', false items receive a score of 1 if answer is 'False'. No points are given when answer is opposite to scoring direction. Score range: 0 to 15, higher score indicated higher sedative effects. Emax: largest effect score between 0 to 24 hours post-dose.|0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose|The pharmacodynamic analysis included all randomized participants in the treatment phase who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter in at least 1 treatment period.||Units on Scale||Standard Deviation|Mean
802578|NCT00975481|Primary|Negative Effects- Addiction Research Center Inventory (ARCI) Lysergic Acid Diethylamide (LSD): Maximum Effect (Emax)|ARCI (LSD) is one of the measures of negative effects. It is a set of 14 questions in which each question contributes to total score. Participants indicate their responses by selecting 'False' or 'True'. One point is given for each response that agrees with scoring direction on scale i.e, true items receive a score of 1 if answer is 'True', false items receive a score of 1 if answer is 'False'. No points are given when the answer is opposite to scoring direction. Score range: 0 to 14, higher score indicated higher negative effects. Emax: largest effect score between 0 to 24 hours post-dose.|0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose|The pharmacodynamic analysis included all randomized participants in the treatment phase who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter in at least 1 treatment period.||Units on Scale||Standard Deviation|Mean
802579|NCT00975481|Primary|Negative Effects- Bad Drug Effects: Peak Effect (Maximum Effect [Emax])|"Bad effects VAS is one of the measures of negative effects that assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm= definitely not) to 'extremely' (score of 100 mm= definitely so).
Emax is largest effect score between 0.5 to 24 hrs."|0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose|The pharmacodynamic analysis included all randomized participants in the treatment phase who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter in at least 1 treatment period.||mm||Standard Deviation|Mean
802580|NCT00975481|Primary|Positive Effects- High VAS: Peak Effect (Maximum Effect [Emax])|"High VAS is one of the measures of positive effects that assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm= definitely not) to 'extremely' (score of 100 mm= definitely so).
Emax is largest effect score between 0 to 24 hours."|0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose|The pharmacodynamic analysis included all randomized participants in the treatment phase who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter in at least 1 treatment period.||mm||Standard Deviation|Mean
802590|NCT00975507|Secondary|Number of Participants With Postvaccination Varicella Antibody Titer ≥5 gpELISA Units/mL for Subjects Initially With Varicella Antibody Titer <1.25 gpELISA Units/mL at Baseline|Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially With Varicella Antibody Titer <1.25 gpELISA units/mL at Baseline|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, Varicella Antibody Titer <1.25 gpELISA units/mL at baseline, and followed protocol procedures.||Participants|||Number
802581|NCT00975481|Primary|Positive Effects- Good Drug Effects: Peak Effect (Maximum Effect [Emax])|"Good drug effects VAS is one of the measures of positive effects that assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm= definitely not) to 'extremely' (score of 100 mm= definitely so).
Emax is the largest effect score between 0.5 to 24 hours post-dose."|0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose|The pharmacodynamic analysis included all randomized participants in the treatment phase who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter in at least 1 treatment period.||mm||Standard Deviation|Mean
802582|NCT00975481|Primary|Positive Effects- Addiction Research Center Inventory (ARCI) Morphine Benzedrine Group (MBG): Maximum Effect (Emax)|ARCI (MBG) is one of the measures of positive effects. It is a set of 16 questions in which each question contributes to total score. Participants indicate their responses by selecting 'False' or 'True'. One point is given for each response that agrees with the scoring direction on scale i.e, true items receive a score of 1 if answer is 'True', false items receive a score of 1 if answer is 'False'. No points are given when the answer is opposite to the scoring direction. Score range: 0 to 16, higher score indicated positive effects. Emax: largest effect score between 0 to 24 hours post-dose.|0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 12, 24 hours post-dose|The pharmacodynamic analysis included all randomized participants in the treatment phase who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter in at least 1 treatment period.||Units on scale||Standard Deviation|Mean
802583|NCT00975481|Primary|Balance of Effects- Subjective Drug Value (SDV): Maximum Effect (Emax)|SDV is one of measures of balance of effects. It is a proxy measure of reinforcing efficacy that involves a series of independent, theoretical forced choices between drug administered and different monetary values. Participants were asked to choose between receiving another dose of same drug or an envelope containing specified amount of money, but they did not receive drug or money as described. Possible score range from 0.25 to 50. Higher score range indicates higher SDV. Emax: largest effect score between 6-24 hours post-dose.|6, 12, 24 hrs post-dose|The pharmacodynamic analysis included all randomized participants in the treatment phase who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter in at least 1 treatment period.||Dollar||Standard Deviation|Mean
802584|NCT00975481|Primary|Balance of Effects- Good and Bad Effects VAS: Peak Effect (Maximum Effect [Emax]) and Minimum Effect (Emin)|"Good and Bad effects VAS is one of the measures of balance of effects that assesses the effect experienced by the participant on a 100 mm bipolar VAS, anchored in the center with a neutral anchor of neither good nor bad effects (score of 50 mm), on the left with bad effects(score of 0 mm) and on the right with good effects (score of 100 mm).
Emax is largest effect score between 0.5 to 24 hours post-dose. Emin is smallest effect score between 0.5 to 24 hours post-dose."|0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose|The pharmacodynamic analysis included all randomized participants in the treatment phase who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter in at least 1 treatment period.||mm||Standard Deviation|Mean
802585|NCT00975481|Primary|Balance of Effects- Take Drug Again VAS: Peak Effect (Maximum Effect [Emax])|"Take drug again VAS is one of the measures of balance of effects. It is a subjective assessment of the degree to which a participant would desire to take the drug again if given the opportunity. It is presented on a 100 mm bipolar VAS with score ranging from 0 mm to 100 mm (score of 0 mm = definitely not, 50 mm = do not care, and 100 mm = definitely so).
Emax is largest effect score between 6 hours to 24 hours."|6, 12, 24 hours post-dose|The pharmacodynamic analysis included all randomized participants in the treatment phase who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter in at least 1 treatment period.||mm||Standard Deviation|Mean
802586|NCT00975481|Primary|Balance of Effects- Overall Drug Liking VAS: Peak Effect (Maximum Effect [Emax]) and Minimum Effect (Emin)|"Overall drug liking VAS is one of the measures of balance of effects that assesses the participant's global perception of drug liking (that is, effects over the whole course of the drug experience including any carryover effects). A 100 mm bipolar VAS is used to assess response based on a score ranging from 0 mm to 100 mm (0 mm = strong disliking, 50 mm= neither like nor dislike, and 100 mm= strong liking).
Emax is the largest effect score between 6 to 24 hours post-dose. Emin is the smallest effect score between 6 to 24 hours post-dose."|6, 12, 24 hours post-dose|The pharmacodynamic analysis included all randomized participants in the treatment phase who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter in at least 1 treatment period.||mm||Standard Deviation|Mean
802587|NCT00975481|Primary|Balance of Effects- Drug Liking VAS: Peak Effect (Maximum Effect [Emax]) and Minimum Effect (Emin)|"Drug liking VAS is one of the measures of balance of effects that assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 millimeter (mm) bipolar visual analogue scale (VAS) anchored in the center with a neutral anchor of neither like nor dislike (score of 50 mm), on the left with strong disliking (score of 0 mm) and on the right with strong liking (score of 100 mm).
Emax is largest effect score between 0.5 to 24 hours post-dose. Emin is smallest effect score between 0.5 to 24 hours post-dose."|0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose|The pharmacodynamic analysis population included all randomized participants in the treatment phase who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter in at least 1 treatment period.||mm||Standard Deviation|Mean
802588|NCT00975507|Secondary|Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL|Antibody Response to Rubella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <10 IU/mL) to Rubella at Baseline|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to rubella at baseline, and followed protocol procedures.||Participants|||Number
802589|NCT00975507|Secondary|Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥2.0 Ab Units/mL|Antibody Response to Mumps at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <2.0 Ab Units/mL) to Mumps at Baseline|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to mumps at baseline, and followed protocol procedures.||Participants|||Number
802634|NCT00982995|Primary|To Determine the Complete Response (no Vomiting and no Need for Nausea Rescue Medication) in Terminally Ill Patients Suffering From Nausea and/or Vomiting, Treated With Palonosetron.||96 hours after dosing|The study was unable to accrue the required number of patients to analyze the primary outcome.|||||
802592|NCT00975507|Primary|Number of Participants With Postvaccination Varicella Antibody Titer ≥5 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL for Subjects Initially Seronegative (a Titer of <0.6 gpELISA Units/mL) to Varicella at Baseline|Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer of <0.6 gpELISA units/mL) to Varicella at Baseline|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to varicella at baseline, and followed protocol procedures.||Participants|||Number
802593|NCT00975585|Secondary|Symptoms of Dryness|Subjects responded to a phone survey question regarding the frequency of the sensation of dryness while wearing the study contact lenses using the following scale: 1=Extreme, 2=Moderate, 3=Slight, 4=None|2 weeks|Analysis includes subjects that completed the study.||units on a scale||Standard Error|Least Squares Mean
802594|NCT00975585|Secondary|Bulbar Redness|The investigator assessed bulbar redness using the following scale: 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe|2 weeks|Analysis includes subjects that completed the study.||units on a scale||Standard Error|Least Squares Mean
802595|NCT00975585|Secondary|Limbal Redness|The investigator assessed limbal redness using the following scale: 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe|2 weeks|Analysis includes subjects that completed the study.||units on a scale||Standard Error|Least Squares Mean
802596|NCT00975585|Primary|Overall Comfort|After four weeks of wear, subjects responded to a phone survey question regarding overall comfort of the study contact lenses (lotrafilcon B)using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.|2 weeks and 4 weeks|Analysis includes all subjects that completed the study.||units on a scale||Standard Error|Least Squares Mean
802597|NCT00975585|Primary|Overall Comfort|After two weeks of wear, subjects responded to a phone survey question regarding overall comfort of the study contact lenses (senofilcon A and lotrafilcon B) using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.|2 weeks|Analysis includes subjects that completed the study.||units on a scale||Standard Error|Least Squares Mean
802598|NCT00975585|Primary|Visual Acuity|Visual acuity was assessed by the investigator using the Snellen chart and converted to the logarithm of the minimum angle of resolution (logMAR). logMAR ideal is 0.0 and represents 20/20 Snellen visual acuity. logMAR values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.|2 weeks|||logMAR units||Standard Error|Least Squares Mean
802599|NCT00975585|Primary|Average Corneal Staining|The overall score is the average of the total scores of each of five regions of the cornea. The minimum average score is 0 and the maximum average score is 3. Corneal surface abnormality as indicated by the severity of staining over five regions of the cornea (central, superior, inferior, nasal and temporal) was assessed by the investigator using the following scale: 0=none, 1=slight, 2=moderate, 3=severe.|2 weeks|Analysis included all subjects that completed the study.||units on a scale||Standard Error|Least Squares Mean
802600|NCT00975611|Primary|Change in Prolactin Levels for Individuals Treated With Adjunctive Amantadine Versus Placebo.||week 4 and week 8|Of the 22 consented subjects, 15 screen-failed because prolactin levels did not meet eligibility criteria and 1 screen-failed due to a positive drug screen. Because of this unanticipated high screen-failure rate, the study was terminated. Only baseline characteristics of all 22 consented/screened subjects were published and are reported here.|||||
802601|NCT00975637|Secondary|Percent of Body Surface Area (BSA) Affected by Psoriasis|To evaluate the efficacy of AMG 827 as measured by the following: Body surface area (BSA) involvement at weeks 12. At the baseline of the study the subject would need to have at least a 10% BSA; at week 12 they were again assessed to see what change ion percentage of BSA has occurred.|Baseline and Week 12|||percentage of BSA psoriasis||Standard Deviation|Mean
802602|NCT00975637|Primary|To Establish a Dose-response Efficacy Profile of AMG 827 Compared With Placebo as Measured by the Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 and to Identify an Appropriate Dose Regimen for Future Trials|At screening a subject would need to have a PASI score of equal to or greater than 12, so at week 12 they were assessed to see percentage of change from there baseline PASI score.|Baseline and 12 weeks|||percentage of psoriasis improvement||Standard Deviation|Mean
802603|NCT00975689|Primary|Oxysterol Levels||Six months|Every patient in the trial received the study drug as well as the placebo.||ng/mL||Standard Error|Mean
802604|NCT00975715|Secondary|Number of Participants With Clinical Global Impression of Change (CGIC) at Final Assessment, by Treatment Group|Clinical Global Impression of Change (CGI) is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). CGI-C scores range from 1 (very much improved) through to 7 (very much worse).|56 days|The Analysis set included all participants who received study drug and had data available for analysis.||participants|||Number
802605|NCT00975715|Secondary|Percent Change in Partial Onset Seizure Frequency During the Double-blind Phase by Seizure Type|Percent change in seizure frequency from baseline = 100 (T-B)/B, B=Seizure frequency per 28 days during baseline phase, T=Seizure frequency per 28 days during the double-blind phase. Seizure frequency per 28 days is calculated as: (seizure frequency during the double-blind phase / the number of days the seizure information were provided) x 28. Only patients with both baseline and corresponding post-baseline values are included.|28 days|Analyzed set includes all participants who received study drug and had both baseline and post baseline data available.||percentage change in seizure frequency||Standard Deviation|Mean
802606|NCT00975715|Secondary|Percent of Participants With Response During Double-blind Phase, by Treatment Group|Responder rate was defined as the percent of participants with an at least 50% reduction in partial onset seizure frequency per 28 days from the screening phase.|screening to 28 days|The Full Analysis set included all participants who received study drug.||percentage of participants|||Number
802607|NCT00975715|Secondary|Partial Seizure Frequency Per 28 Days, by Study Period (Every 28 Days) and Treatment Group|Partial onset seizure frequency per 28 days during a period between baseline and Week 4 was measured. Partial onset seizure frequency per 28 days (count/28 days)” = Number of partial onset seizures during each phase (screening phase or double-blind phase) / Number of days during the phase x 28.|baseline, 28 days and 56 days|The Full Analysis set included all participants who received study drug.||seizures per 28 days||Standard Deviation|Mean
802608|NCT00975715|Primary|Percent Change in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Double-blind Phase, by Treatment Group|Percent change in partial onset seizure frequency per 28 days during the double-blind phase from the screening phase, was calculated according to the following formula: “Percent change in partial onset seizure frequency per 28 days from the screening phase” = (partial onset seizure frequency per 28 days during the double-blind phase - partial onset seizure frequency per 28 days during the screening phase) / partial onset seizure frequency per 28 days during the double-blind phase x 100 “Partial onset seizure frequency per 28 days” = Number of partial onset seizures during each phase (screening phase or double-blind phase) / number of days during the screening or double-blind phase × 28.|screening and 28 days|The Full Analysis set included all participants who received study drug.||percentage change per 28 days||Standard Deviation|Mean
802609|NCT00975780|Secondary|Lower Respiratory Tract Infection Other Than Pneumonia|The number of participants that recorded a 'lower respiratory tract infection other than pneumonia' during the 2.5 years timeframe.|2.5 years|||participants|||Number
802610|NCT00975780|Primary|Pneumonia|The number of participants that recorded a 'first pneumonia' during the 2.5 years timeframe.|2.5 years|||participants|||Number
802611|NCT00975806|Secondary|Overall Survival (OS)|Overall survival was defined as the time from the start of study drug therapy to death.|Day 1 of study drug to death|Analysis was not performed due to the early termination of the study. The cumulative frequency and severity of toxicities observed at each dose level, including Maximum Tolerated Dose (MTD), were higher than expected and evident during all cycles and all dose levels in Phase 1. The decision was made not to open the Phase 2 portion of the study.|||||
802612|NCT00975806|Secondary|Duration of Response|Duration of response was defined as the time from the initial response date to progressive disease (PD) for participants who achieved an objective confirmed complete response (CR) or partial response (PR)|Day 1 of initial response date to progressive disease|Analysis was not performed due to the early termination of the study. The cumulative frequency and severity of toxicities observed at each dose level, including Maximum Tolerated Dose (MTD), were higher than expected and evident during all cycles and all dose levels in Phase 1. The decision was made not to open the Phase 2 portion of the study.|||||
802613|NCT00975806|Secondary|Progression Free Survival (PFS)|Progression-free survival was defined as the time from the start of study drug therapy to the first observation of disease progression or death due to any cause, whichever came first.|Day 1 of study drug to disease progression or death|Analysis was not performed due to the early termination of the study. The cumulative frequency and severity of toxicities observed at each dose level, including MTD, were higher than expected and evident during all cycles and all dose levels in Phase 1. The decision was made not to open the Phase 2 portion of the study.|||||
802614|NCT00975806|Secondary|Phase 1 : Tumor Response Rate According to RECIST 1.1|"Tumor response was evaluated every 3 cycles beginning with Cycle 3 Day 1 and at treatment discontinuation. Response was evaluated using the Response Criteria Evaluation in Solid Tumors (RECIST 1.1) criteria:
Treatment response includes both complete response and partial response
Complete response-disappearance of all lesions
Partial response-30% decrease in the sum of diameters of target lesions from baseline
Stable disease-neither shrinkage nor increase of lesions
Progressive Disease-20% increase in the sum of diameters of target lesions from nadir"|Every 3 cycles; up to month 25|Intent to Treat Population includes participants who took at least one dose of study drug. Study participants with stable disease also reported.||participants|||Number
802615|NCT00975806|Secondary|Phase 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) While on Both Lenalidomide and Sunitinib|Adverse event (AE) = any noxious, unintended, or untoward medical occurrence occurring at any dose that may appear or worsen in a participant during the course of a study, including new intercurrent illness, worsening concomitant illness, injury, or any concomitant impairment of participants health, including laboratory test values, regardless of etiology. Serious adverse event (SAE) = any AE which: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. TEAE = any AE occurring or worsening on or after the first treatment with any study drug. Related = suspected by investigator to be related to study treatment. National Cancer Institute [NCI] Common Toxicity Criteria for Adverse Events [CTCAE], Version 4.0, grades: 1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, 5 = death|First day of study drug to within 28 days after the last dose of the last study drug; The duration of exposure to lenalidomide and sunitinib was 7.0 to 327 and 7.0 to 328 days respectively|Safety population includes all participants who received at least one dose of study drug.||participants|||Number
802616|NCT00975806|Primary|Phase 2: Tumor Response Rate According to Response Evaluation Criteria In Solid Tumors (RECIST 1.1)|"Tumor response was to be evaluated every 3 cycles beginning with Cycle 3 Day 1 and at treatment discontinuation. Response was to be defined by RECIST 1.1 criteria:
Complete response-disappearance of all lesions
Partial response-30% decrease in the sum of diameters of target lesions from baseline
Stable disease-neither shrinkage nor increase of lesions.
Progressive Disease-20% increase in the sum of diameters of target lesions from nadir."|After at least 3 cycles of treatment|Analysis was not performed due to the early termination of the study. The cumulative frequency and severity of toxicities observed at each dose level, including Maximum Tolerated Dose (MTD), were higher than expected and evident during all cycles and all dose levels in Phase 1. The decision was made not to open the Phase 2 portion of the study.|||||
802617|NCT00975806|Primary|Phase 1: Maximum Tolerated Dose (MTD)|"The MTD of lenalidomide in combination with sunitinib was defined as the highest dose level at which no more than 1 out of 6 participants experienced a dose limiting toxicity (DLT). Dose limiting toxicities were:
• Inability to deliver Lenalidomide in Cycle 1 due to a drug-related toxicity resulting in:
Grade (GR) 3 or 4 non-hematological toxicity lasting for ≥ 14 days
Febrile neutropenia
Gr 4 neutropenia lasting for ≥ 7 days
Gr 4 thrombocytopenia The occurrence of one of the above drug-related toxicities resulting in a clinical and/or laboratory assessment being done within 7 days following the initial finding to examine the participants for resolution of the toxicity. Lack of resolution of the toxicities was considered a DLT.
If ≤ 7 doses of lenalidomide or Sunitinib were missed in Cycle 1 due to non-drug related event, the participant data was to be included in the evaluation of dose escalation."|Within 21 days of first dose of treatment|Safety population includes all participants who received at least one dose of the study drug.||mg|||Number
805095|NCT01002989|Primary|Mean Watch BP Office Ankle-Brachial Index||once (cross-sectional)|||ratio||Standard Deviation|Mean
802619|NCT00975923|Primary|CLABSI and VAP Rates|Central line associated bloodstream infections(CLABSI) and ventilator associated pneumonias (VAP) using Centers for Disease Control and Prevention definitions as number of events per 1,000 device days, data collection and surveillance methods.|18 Months: 3-month baseline and quarterly post-intervention periods|A cluster randomized trial randomly assigned hospitals to either the Collaborative or Tool Kit groups, stratified by region within the United States and ICU volume. Implementation and analysis was at the level of the ICU. One of the 30 hospital in the Tool Kit Group was sold, leaving 29 hospitals. Analysis was conducted per protocol.||events/1000 device days||Inter-Quartile Range|Median
802620|NCT00981630|Secondary|Participants With Japanese Encephalitis (Homologous Virus) Seropositivity Over Time Following Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or Placebo|Antibodies were measured using 50% plaque reduction neutralization test (PRNT50) for measurement of neutralizing antibodies against homologous ChimeriVax™-JE virus strains. Seropositivity was defined as a titer < 1:10.|Day 30 up to 12 months post-vaccination|Seropositivity was assessed in all participants who were negative for homologous and all wild type JE antibodies at Day 0 and had no protocol violations that might have interfered with evaluation of primary criterion (Per-Protocol Population).||Participants|||Number
802621|NCT00981630|Secondary|Geometric Mean Titers to Japanese Encephalitis (Wild Type JE Virus Strains) Following Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or a Placebo|The Japanese Encephalitis (Wild Type JE Virus Strains) antibodies were measured using PRNT50 for measurement of neutralizing antibodies against homologous ChimeriVax™-JE and wild type JE virus strains.|Day 30 post-vaccination|Geometric mean titers were assessed in all participants who were negative for homologous and all wild type JE antibodies at Day 0 and had no protocol violations that might have interfered with evaluation of primary criterion (Per-Protocol Population).||Titers||95% Confidence Interval|Geometric Mean
802622|NCT00981630|Secondary|Geometric Mean Titers to Japanese Encephalitis (Homologous Virus) Following Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or a Placebo|Antibodies were measured using 50% plaque reduction neutralization test (PRNT50) for measurement of neutralizing antibodies against homologous ChimeriVax™-JE virus strains.|Day 11 and Day 30 post-vaccination|Geometric Mean Titers were assessed in all participants who were negative for homologous and all wild type JE antibodies at Day 0 and had no protocol violations that might have interfered with evaluation of primary criterion (Per-Protocol Population).||Titers||95% Confidence Interval|Geometric Mean
802623|NCT00981630|Primary|Number of Participants Reporting Solicited Local Injection Site and Treatment Related Adverse Events Post Vaccination With One of 3 Doses of ChimeriVax™-JE Vaccine or Placebo|Local Injection Site Adverse Events (AEs): Pain, Erythema, Reaction, Hemorrhage, Induration, Paresthesia. Treatment Related Systemic AEs: Fever, Chills, Malaise, Fatigue, Headache, Myalgia, Arthralgia, Nausea, Vomiting, Diarrhea, Rash. Other AEs as reported spontaneously.|Day 0 (post-vaccination) up to Day 30 post-vaccination|Adverse events were assessed in all randomized participants who received one injection of study treatment, according to the treatment actually received (Safety Population).||Participants|||Number
802624|NCT00981630|Primary|Number of Participants Who Seroconverted to Wild Type JE Virus Strains After Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or a Placebo|Antibodies were measured using 50% plaque reduction neutralization test (PRNT50) for measurement of neutralizing antibodies against homologous ChimeriVax™-JE and wild type JE virus strains. Seroconversion was defined as a titer ≥ 1:20 at post vaccination time points for subjects who were seronegative at baseline, or ≥ 4 fold rise from baseline.|Day 30 post-vaccination|Seroconversion was assessed in all participants who were negative for homologous and all wild type JE antibodies at Day 0 and had no protocol violations that might have interfered with evaluation of primary criterion.||Participants|||Number
802625|NCT00981630|Primary|Number of Participants Who Seroconverted to the Respective Homologous JE Vaccine Strain, 28 Days After Completion of the Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or A Placebo|Antibodies were measured using 50% plaque reduction neutralization test (PRNT50) for measurement of neutralizing antibodies against homologous ChimeriVax™-JE and wild type JE virus strains. Seroconversion was defined as a titer ≥ 1:20 at post vaccination timepoints for subjects who were seronegative at baseline, or ≥ 4 fold rise from baseline.|Day 11 and Day 30 post-vaccination|Seroconversion was assessed in all participants who were negative for homologous and all wild type JE antibodies at Day 0 and had no protocol violations that might have interfered with evaluation of primary criterion.||Participants|||Number
802626|NCT00981669|Primary|Number of Participants With Adverse Events.|Safety and tolerability were evaluated by monitoring occurence of fever, diarrhea, vomiting, abdominal pain and increase of liver enzymes.|Within the first five days post-vaccination.|||participants|||Number
802627|NCT00981669|Secondary|Anti-rotavirus IgA Level.|It was evaluated by anti-rotavirus IgA levels in terms of optical density. Pre-vaccination levels of anti-rotavirus antibodies were not considered as an exclusion criterion. Seroconversion was considered as a fourfold increase in IgA titers. The proportion of seroconverters in both groups was compared. IgA levels in optical density were not converted to any unit of measure.|before each dose (total of doses:3) and after 6 weeks of the third dose|As in most phase I trials, sample size was not calculated to provide statistically significant differences between groups. Rather, a descriptive analysis on the frequency of AE and immunogenicity data was undertaken.||Arbitrary units||Inter-Quartile Range|Median
802628|NCT00981812|Primary|Feasibility That Breast Biopsy Can be Performed Using PEM and Stereo Navigator Software After Diagnostic PEM on the Same Day.||At time of biopsy|||Breast Lesions|||Number
802629|NCT00981825|Primary|CFU (Colony Forming Units)|Total number of salivary bacterial colony forming units (lower number = less colonies present)|4 hours|||number of colony forming units||Standard Deviation|Mean
802630|NCT00982735|Secondary|Change From Baseline in Microalbuminuria at 24 Weeks||Baseline and 24 weeks|||Participants|||Number
802631|NCT00982735|Secondary|Assessment by Attending Physicians on the Effectiveness of Treatment With Telmisartan, According to Their Opinion|A 5-point scale was used by the attending physicians to assess the effectiveness of Telmisartan according to their opinion. The scale was rated from 0 (not satisfactory), 1 (marginal), 2 (satisfactory), 3 (very satisfactory) to 4 (outstanding).|24 weeks|||Participants|||Number
802632|NCT00982735|Primary|Number of Patients Achieving Blood Pressure (BP) Control, Sitting Diastolic BP Over Systolic BP 90 Over 140 mm Hg and/or Reduction From Baseline in Sitting Systolic BP or Diastolic BP More Than 10 mm Hg.||24 weeks|||Participants|||Number
802635|NCT00983073|Secondary|Change From Baseline in the Western Ontario McMaster Questionnaire (WOMAC) Global Score Assessing Pain, Disability and Joint Stiffness of the Knee Over the Last Week at Week 12|The WOMAC is a self-administered questionnaire and has 24 questions: Pain, Stiffness and Physical Function. The possible scores range from 0-20 for pain, 0-8 for stiffness, 0-68 for physical function and these are then summed 0-96 for the global score. The negative value indicates that there has been an improvement since baseline, the higher the value the greater the change since baseline.|Baseline; End of Week 12 (12 Weeks)|Number of participants with data available||units on a scale||Standard Deviation|Mean
802636|NCT00983073|Secondary|Change From Baseline in the Western Ontario McMaster Questionnaire (WOMAC) Global Score Assessing Pain, Disability and Joint Stiffness of the Knee Over the Last Week at Week 6|The WOMAC is a self-administered questionnaire and has 24 questions: Pain, Stiffness and Physical Function. The possible scores range from 0-20 for pain, 0-8 for stiffness, 0-68 for physical function and these are then summed 0-96 for the global score. The negative value indicates that there has been an improvement since baseline, the higher the value the greater the change since baseline.|Baseline; End of Week 6 (6 Weeks)|Number of participants with data available||units on a scale||Standard Deviation|Mean
802637|NCT00983073|Secondary|Baseline Western Ontario McMaster Questionnaire (WOMAC) Global Score Assessing Pain, Disability and Joint Stiffness of the Knee|Western Ontario McMaster Questionnaire (WOMAC) Global Score: WOMAC is measured with a Likert ordinal scale (the participant gives one of 5 possible answers) A higher score indicate that a symptom is bothersome or disabling. The WOMAC is a self-administered questionnaire and has 24 questions: Pain, Stiffness and Physical Function. The possible scores range from 0-20 for pain, 0-8 for stiffness, 0-68 for physical function and these are then summed 0-96 for the global score. A lower score indicates a lower level of symptoms and or disability.|Baseline|Number of participants with data available||units on a scale||Standard Deviation|Mean
802638|NCT00983073|Secondary|Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol.|Participants were requested to rate their tapentadol (new) analgesic medication on a 5-point scale. The medication was rated as excellent, very good, good, fair and poor.|Baseline; End of Week 12 (12 Weeks)|Number of participants with data available||participants|||Number
802639|NCT00983073|Secondary|Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol.|Participants were requested to rate their tapentadol (new) analgesic medication on a 5-point scale. The medication was rated as excellent, very good, good, fair and poor.|Baseline; End of Week 6 (6 Weeks)|Number of participants with data available||participants|||Number
802640|NCT00983073|Secondary|Participant's Satisfaction With Previous Analgesic Treatment|Participants were requested to rate their previous analgesic medication on a 5-point scale. Previous medication was rated as excellent, very good, good, fair and poor.|Baseline|Number of participants with data available.||participants|||Number
802641|NCT00983073|Secondary|Clinical Global Impression of Change|In the Clinical Global Impression of Change (CGIC) the clinician indicates the perceived change over the treatment period. The clinician is requested to choose one of seven categories. Scores range from very much improved to very much worse.|Baseline; End of Week 12 (12 Weeks)|Number of participants with data available||Participants|||Number
802642|NCT00983073|Secondary|Clinical Global Impression of Change|In the Clinical Global Impression of Change (CGIC) the clinician indicates the perceived change over the treatment period. The clinician is requested to choose one of seven categories. Scores range from very much improved to very much worse.|Baseline; End of Week 6 (6 Weeks)|Number of participants with data available||Participants|||Number
802643|NCT00983073|Secondary|Patient Global Impression of Change|In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant is requested to choose one of seven categories. Scores range from very much improved to very much worse.|Baseline; End of Week 12 (12 Weeks)|Number of participants with data available||Participants|||Number
802644|NCT00983073|Secondary|Patient Global Impression of Change|In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant is requested to choose one of seven categories. Scores range from very much improved to very much worse.|Baseline; End of Week 6 (6 Weeks)|Number of participants with data available||Participants|||Number
802645|NCT00983073|Secondary|Change in Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS)|EuroQoL-5D Health State Visual Analog Scale (VAS) is a participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. The values indicated represent the change from the baseline, a positive value indicates an improvement.|Baseline, End of Week 12 (12 Weeks)|Number of participants with data available||Units on a scale||Standard Deviation|Mean
802646|NCT00983073|Secondary|Change in Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS)|EuroQoL-5D Health State Visual Analog Scale (VAS) is a participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. The values indicated represent the change from the baseline, a positive value indicates an improvement.|Baseline; End of Week 6 (6 Weeks)|Number of participants with data available.||Units on a scale||Standard Deviation|Mean
802647|NCT00983073|Secondary|EuroQol-5 (EQ-5D) Health Status Index Outcome Over Time|"The participant scored the EuroQol-5. This is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating full health and 0 representing dead. The positive values indicate that during the study the health status improved."|Baseline; End of Week 12 (12 Weeks)|Number of participants with data available||Units on a scale||Standard Deviation|Mean
802662|NCT00983294|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that colchicine reaches in the plasma.|serial pharmacokinetic plasma concentrations were drawn prior to colchicine dose administration (0 hour) on Days 1 and 19, then at 0.5, 1.0, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after colchicine dose administration|||pg/mL||Standard Deviation|Mean
805096|NCT01002989|Primary|Mean Doppler Ankle-Brachial Index||once (cross-sectional)|||ratio||Standard Deviation|Mean
802648|NCT00983073|Secondary|EuroQol-5 (EQ-5D) Health Status Index Outcome Over Time|"The participant scored the EuroQol-5. This is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating full health and 0 representing dead. The positive values indicate that during the study the health status improved."|Baseline; End of Week 6 (6 Weeks)|Number of participants with data available.||Units on a scale||Standard Deviation|Mean
802649|NCT00983073|Secondary|Change in Average Pain Intensity After 12 Weeks of Tapentadol PR Treatment|"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. The value indicates the change from the baseline value on the 0 to 10 scale. A Negative value indicates a reduction in pain intensity from the baseline average pain intensity."|Baseline; End of Week 12 (12 Weeks)|Number of participants with data available.||units on a scale||Standard Deviation|Mean
802650|NCT00983073|Secondary|Change in Average Pain Intensity After 6 Weeks of Tapentadol PR Treatment|"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. The value indicates the change from the baseline value on the 0 to 10 scale. A Negative value indicates a reduction in pain intensity from the baseline average pain intensity."|Baseline; End of Week 6 (6 Weeks)|Number of participants with data available.||units on a scale||Standard Deviation|Mean
802651|NCT00983073|Secondary|Average Pain Intensity Before the Start of Tapentadol Treatment|"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale (NRS)where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Baseline|||units on a scale||Standard Deviation|Mean
802652|NCT00983073|Primary|The Primary Endpoint is Defined as the Change From Week -1 of the Average Pain Intensity Score on an 11-point NRS-3 at Week 6.|"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. The value indicates the change from the baseline value on the 0 to 10 scale. A Negative value indicates a reduction in pain intensity from the baseline average pain intensity."|Baseline to end of week 6|All participants who had at least one dose of study medication and one post-baseline pain intensity assessment. Last Observation Carried Forward (LOCF).||Units on a scale||Standard Deviation|Mean
802653|NCT00983216|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the colchicine plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable colchicine plasma concentration to the elimination rate constant.|serial pharmacokinetic blood samples drawn within 1 hour prior to colchicine dosing (0 hour) on Days 1 and 19, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72 and 96 hours after colchicine dose administration|||pg-hr/mL||Standard Deviation|Mean
802654|NCT00983216|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the colchicine plasma concentration versus time curve, from time 0 to the time of the last measurable colchicine concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic blood samples drawn within 1 hour prior to colchicine dosing (0 hour) on Days 1 and 19, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72 and 96 hours after colchicine dose administration|||pg-hr/mL||Standard Deviation|Mean
802655|NCT00983216|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that colchicine reaches in the plasma.|serial pharmacokinetic blood samples drawn within 1 hour prior to colchicine dosing (0 hour) on Days 1 and 19, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72 and 96 hours after colchicine dose administration|||pg/mL||Standard Deviation|Mean
802656|NCT00983242|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable colchicine plasma concentration to the elimination rate constant.|On Days 1 and 19 - serial pharmacokinetic blood samples were collected pre-dose and at 0.5, 1.0, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose.|||pg-hr/mL||Standard Deviation|Mean
802657|NCT00983242|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve beginning from the first dose (time 0) to the last measurable colchicine concentration (time t), as calculated by the linear trapezoidal method.|On Days 1 and 19 - serial pharmacokinetic blood samples were collected pre-dose and at 0.5, 1.0, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose.|||pg-hr/mL||Standard Deviation|Mean
802658|NCT00983242|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that colchicine reaches in the plasma.|On Days 1 and 19 - serial pharmacokinetic blood samples were collected pre-dose and at 0.5, 1.0, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose.|||pg/mL||Standard Deviation|Mean
802659|NCT00983281|Primary|Mortality||Overall inpatient mortality upon discharge from the hospital with a mean length of stay of 8 days.|||participants|||Number
802660|NCT00983294|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the colchicine plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable colchicine plasma concentration to the elimination rate constant.|serial pharmacokinetic plasma concentrations were drawn prior to colchicine dose administration (0 hour) on Days 1 and 19, then at 0.5, 1.0, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after colchicine dose administration|||pg-hr/mL||Standard Deviation|Mean
802661|NCT00983294|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the colchicine plasma concentration versus time curve, from time 0 to the time of the last measurable colchicine concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic plasma concentrations were drawn prior to colchicine dose administration (0 hour) on Days 1 and 19, then at 0.5, 1.0, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after colchicine dose administration|||pg-hr/mL||Standard Deviation|Mean
802664|NCT00983359|Secondary|Karnofsky Decay Time|Time from enrollment to the date the patient’s Karnofsky performance score drops below 60. If the patient dies of any cause with no documentation of a drop in their Karnofsky score to less than 60, the date of death will be used as the date of worsening of the Karnofsky score. A patient with a Karnofsky score of 60 or greater requires occasional assistance, but is able to care for most of his/her needs. A patient’s Karnofsky decay time will be considered censored if the patient is still under follow up with a Karnofsky score of 60 or greater and if the patient dies of a non-cancer-related cause.|From time of enrollment up to 5 years|||months||Full Range|Median
802665|NCT00983359|Secondary|Time to Systemic Death|Descriptive analysis will be conducted using Kaplan-Meier survival analysis|From time of enrollment up to 5 years|||months||95% Confidence Interval|Median
802666|NCT00983359|Secondary|Time to Neurological Death|Time from enrollment to date of death directly due to brain metastases. Deaths from other causes including hemorrhage or infection will be considered ‘censored’ observations in the setting of neurologic improvement or stabilization. If the patient dies of any cause with worsening of neurologic symptoms, the death will be counted as an ‘event’ or neurological death.|From time of enrollment up to 5 years|||months||Full Range|Median
802667|NCT00983359|Secondary|Progression-free Survival (PFS)|Time from enrollment to first date of progressive or recurrent disease. Worsening of neurological symptoms is considered indicative of neurological disease progression. Patients who die of disease-related or treatment-related causes will be considered to have progressed at their date of death; i.e., not be considered ‘censored’. PFS will be considered censored only if no progression is noted or if the patient dies of a clearly non-cancer-related event such as accident.|Up to 5 years|||months||95% Confidence Interval|Median
802668|NCT00983359|Primary|Proportion of Patients Dying of Neurological Death, Defined as Dying With Progressive Neurological Dysfunction Regardless of Systemic Disease Status|Neurological death is defined as dying with progressive neurological dysfunction regardless of systemic disease status. Patients wtih severe neurological disability who die of intercurrent illness will also be considered to have died of neurological death.|Up to 5 years|||patients|||Number
802669|NCT00983372|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable colchicine plasma concentration to the elimination rate constant.|serial pharmacokinetic blood samples drawn immediately prior to dosing on Days 1 and 21, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after dose administration|||pg-hr/mL||Standard Deviation|Mean
802670|NCT00983372|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable colchicine concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic blood samples drawn immediately prior to dosing on Days 1 and 21, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after dose administration|||pg-hr/mL||Standard Deviation|Mean
802671|NCT00983372|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that colchicine reaches in the plasma.|serial pharmacokinetic blood samples drawn immediately prior to dosing on Days 1 and 21, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after dose administration|||pg/mL||Standard Deviation|Mean
802672|NCT00983385|Secondary|NRS-3 Pain Intensity Assessment in Participants With Prior Opioid Treatment at the End of the Maintenance Period.|"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|End of Week 12|Intention to treat (ITT). Negative painDETECT subpopulation - 8 participants. Unclear and positive painDETECT subpopulation - 42 participants||Units on a scale||Standard Deviation|Mean
802673|NCT00983385|Secondary|NRS-3 Pain Intensity Assessment in Participants With Prior Opioid Treatment at the End of the Titration and Optimal Dose Period.|"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|End of Week 6|Intention to treat (ITT). Negative painDETECT subpopulation - 13 participants. Unclear and positive painDETECT subpopulation - 62 participants||Units on a scale||Standard Deviation|Mean
802674|NCT00983385|Secondary|Baseline NRS-3 Pain Intensity in Participants With Prior Opioid Treatment, at Baseline.|"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Baseline|Intention to treat (ITT). Negative painDETECT subpopulation - 18 participants. Unclear and positive painDETECT subpopulation - 70 participants||Units on a scale||Standard Deviation|Mean
802675|NCT00983385|Secondary|NRS-3 Pain Intensity in Participants With No Prior Opioid Treatment at the End of the Maintenance Period.|"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|End of Week 12|Intention to treat (ITT). Negative painDETECT subpopulation - 15 participants. Unclear and positive painDETECT subpopulation - 24 participants||Units on a scale||Standard Deviation|Mean
802676|NCT00983385|Secondary|NRS-3 Pain Intensity in Participants With No Prior Opioid Treatment at the End of the Titration and Optimal Dose Period.|"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|End of Week 6|Intention to treat (ITT). Negative painDETECT subpopulation - 22 participants. Unclear and positive painDETECT subpopulation - 37 participants||Units on a scale||Standard Deviation|Mean
802677|NCT00983385|Secondary|Baseline NRS-3 Pain Intensity in Participants With No Prior Opioid Treatment, at Baseline.|"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Baseline|Intention to treat (ITT). Negative painDETECT subpopulation - 31 participants. Unclear and positive painDETECT subpopulation - 56 participants||Units on a scale||Standard Deviation|Mean
802680|NCT00983385|Secondary|Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol, at the End of Titration and Optimal Dose Period.|Participants were requested to rate their tapentadol (new) analgesic medication on a 5-point scale. The medication was rated as excellent, very good, good, fair and poor.|End of Week 6|Intention to treat (ITT).||participants|||Number
802681|NCT00983385|Secondary|Participant's Satisfaction With Previous Analgesic Treatment at Baseline|Participants were requested to rate their previous analgesic medication on a 5-point scale. Previous analgesic medication was rated as excellent, very good, good, fair and poor.|Baseline|||participants|||Number
802682|NCT00983385|Secondary|Final Stable Tapentadol PR Dose in Opioid Naive Participants at End of Titration and Optimal Dose Period.|Tapentadol hydrochloride PR dose after 5 weeks of titration which was to be kept stable during the remained of the trial.|Week 6|Negative painDETECT subpopulation - 22 participants Unclear painDETECT subpopulation - 15 participants Positive painDETECT subpopulation - 22 participants Intention to treat (ITT).||milligrams (mg)||Standard Deviation|Mean
802683|NCT00983385|Secondary|Hospital Anxiety Depression Scale: Change in Depression Score at End of Maintenance Period|"Depression Scale - 7 items scored for each individual question from 0 = best and 3 = worst.
HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 14 items. Seven statements describe depression. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points.
A negative value indicates that there has been an improvement."|Baseline; End of Week 12 (12 Weeks)|"Negative painDETECT subpopulation - 23 participants Unclear and positive painDETECT subpopulation - 66 participants.
Intention to Treat (ITT)."||units on a scale||Standard Deviation|Mean
802684|NCT00983385|Secondary|Hospital Anxiety Depression Scale: Change in Depression Score at End of Titration and Optimal Dose Period.|"Depression Scale - 7 items scored for each individual question from 0 = best and 3 = worst.
HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 14 items. Seven statements describe depression. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points.
A negative value indicates that there has been an improvement."|Baseline; End of Week 6 (6 weeks)|Negative painDETECT subpopulation - 34 participants Unclear or positive painDETEC subpopulation - 94 participants Intention to Treat (ITT).||units on a scale||Standard Deviation|Mean
802685|NCT00983385|Secondary|Hospital Anxiety Depression Scale: Depression Score at Baseline|"Depression Scale - 7 items scored for each individual question from 0 = best and 3 = worst.
HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 14 items. Seven statements describe anxiety. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points.
A negative value indicates that there has been an improvement."|Baseline|Negative painDETECT subpopulation - 49 participants Unclear and positive painDETECT subpopulation - 124 participants Intention to Treat (ITT).||units on a scale||Standard Deviation|Mean
802686|NCT00983385|Secondary|Hospital Anxiety Depression Scale: Change in Anxiety Score at End of Maintenance Period|"Anxiety Scale - 7 items scored for each individual question from 0 = best and 3 = worst.
HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 14 items. Seven statements describe anxiety. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points.
A negative value indicates that there has been an improvement."|Baseline; End of Week 12 (12 Weeks)|Negative painDETECT subpopulation - 23 participants Unclear and positive painDETECT subpopulation - 66 participants Intention to Treat (ITT).||units on a scale||Standard Deviation|Mean
802687|NCT00983385|Secondary|Hospital Anxiety Depression Scale: Change in Anxiety Score at End of Titration and Optimal Dose Period|"Anxiety Scale - 7 items scored for each individual question from 0 = best and 3 = worst.
HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 14 items. Seven statements describe anxiety. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points.
A negative value indicates that there has been an improvement."|Baseline; End of Week 6 (6 weeks)|Negative painDETECT subpopulation - 34 participants Unclear and positive painDETECT subpopulation - 94 participants Intention to Treat (ITT).||units on a scale||Standard Deviation|Mean
802688|NCT00983385|Secondary|Hospital Anxiety Depression Scale: Anxiety Score at Baseline|"Anxiety Scale - 7 items scored for each individual question from 0 = best and 3 = worst.
HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 14 items. Seven statements describe anxiety. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points.
A negative value indicates that there has been an improvement."|Baseline|Negative painDETECT subpopulation - 49 participants Unclear and positive painDETECT subpopulation - 124 participants Intention to Treat (ITT).||units on a scale||Standard Deviation|Mean
802689|NCT00983385|Secondary|Clinical Global Impression of Change (All Participants) at End of Maintenance Period|In the Clinical Global Impression of Change (CGIC) the clinician indicates the perceived change over the treatment period. The clinician is requested to choose one of seven categories. Scores range from very much improved to very much worse.|Baseline; End of Week 12 (12 weeks)|Intention to treat (ITT).||participants|||Number
802690|NCT00983385|Secondary|Clinical Global Impression of Change (All Participants) at End of Titration and Optimal Dose Period|In the Clinical Global Impression of Change (CGIC) the clinician indicates the perceived change over the treatment period. The clinician is requested to choose one of seven categories. Scores range from very much improved to very much worse.|Baseline; End of Week 6 (6 weeks)|Intention to treat (ITT).||participants|||Number
802691|NCT00983385|Secondary|Change in Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS) at End of Maintenance Period|EuroQoL-5D Health State Visual Analog Scale (VAS) is a participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. The values indicated represent the change from the baseline, a positive value indicates an improvement.|Baseline; End of Week 12 (12 weeks)|Intention to treat (ITT). painDETECT negative subpopulation - 23 participants. Unclear and positive painDETECT subpopulation - 66 participants.||Units on a scale||Standard Deviation|Mean
812459|NCT01070784|Primary|Clinical Laboratory Test: Clinical Chemistry- S-Potassium|Change from baseline|Baseline and 52 week after|||mEq/L||Standard Deviation|Mean
802692|NCT00983385|Secondary|EuroQol-5 (EQ-5D) Health Status Index Outcome Over Time at End of Maintenance Period|"The participant scored the EuroQol-5. This is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating full health and 0 representing dead. The positive values indicate that during the study the health status improved."|Baseline; End of Week 12 (12 weeks)|Intention to treat (ITT). Unclear and positive painDETECT subpopulation - 66 participants. painDETECT negative subpopulation - 23 participants.||units on a scale||Standard Deviation|Mean
802693|NCT00983385|Secondary|Change in Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS)at End of Titration and Optimal Dose Period.|EuroQoL-5D Health State Visual Analog Scale (VAS) is a participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. The values indicated represent the change from the baseline, a positive value indicates an improvement.|Baseline; End of Week 6 (6 weeks)|Intention to treat (ITT). painDETECT negative subpopulation - 34 participants. Unclear and positive painDETECT subpopulation - 97 participants.||Units on a scale||Standard Deviation|Mean
802694|NCT00983385|Secondary|EuroQol-5 (EQ-5D) Health Status Index Outcome Over Time at End of Titration and Optimal Dose Period.|"The participant scored the EuroQol-5. This is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating full health and 0 representing dead. The positive values indicate that during the study the health status improved."|Baseline; End of Week 6 (6 weeks)|Intention to treat (ITT). painDETECT negative subpopulation - 35 participants. Unclear and positive painDETECT subpopulation - 98 participants.||Units on a scale||Standard Deviation|Mean
802695|NCT00983385|Secondary|Change in Neuropathic Pain Symptom Inventory (NPSI) Final Score Assessment at End of the Maintenance Period|Change in mean score NPSI, questionnaire evaluates symptoms of neuropathic pain. Ten pain descriptors questions are answered on an 11-point scale 0 (no pain)-10 (most intense pain imaginable). The NPSI derives a total intensity score calculated from the subscores. A negative value indicates improvement in neuropathic symptoms.|Baseline; End of Week 12 (12 Weeks)|Intention to treat (ITT), Last Observation Carried Forward (LOCF).||units on a scale||Standard Deviation|Mean
802696|NCT00983385|Secondary|Change in Neuropathic Pain Symptom Inventory (NPSI) Final Score Assessment at End of Titration and Optimal Dose Period|Change in mean score NPSI, questionnaire evaluates symptoms of neuropathic pain. Ten pain descriptors questions are answered on an 11-point scale 0 (no pain)-10 (most intense pain imaginable). The NPSI derives a total intensity score calculated from the subscores. A negative value indicates improvement in neuropathic symptoms.|Baseline; End of Week 6 (6 Weeks)|Intention to treat (ITT), Last Observation Carried Forward (LOCF).||Units on a scale||Standard Deviation|Mean
802697|NCT00983385|Secondary|Neuropathic Pain Symptom Inventory (NPSI) Subscores and Overall Score Assessment at End of the Maintenance Period|Mean score NPSI (Neuropathic Pain Symptom Inventory). The participant rates their symptoms of neuropathic pain. Ten pain questions are answered on an 11-point scale 0 (no pain) to 10 (most intense pain imaginable). Two items related to temporal pain assessed on 5-point scales.|End of Week 12|Intention to treat (ITT).||units on a scale||Standard Deviation|Mean
802698|NCT00983385|Secondary|Neuropathic Pain Symptom Inventory (NPSI) Subscores and Overall Score at End of Titration and Optimal Dose Period|Mean score NPSI (Neuropathic Pain Symptom Inventory). The participant rates their symptoms of neuropathic pain. Ten pain questions are answered on an 11-point scale 0 (no pain) to 10 (most intense pain imaginable). Two items related to temporal pain assessed on 5-point scales.|End of Week 6|Intention to treat (ITT).||units on a scale||Standard Deviation|Mean
802699|NCT00983385|Secondary|Neuropathic Pain Symptom Inventory (NPSI) Subscores and Overall Score Assessment at Baseline|Mean score NPSI (Neuropathic Pain Symptom Inventory). The participant rates their symptoms of neuropathic pain. Ten pain questions are answered on an 11-point scale 0 (no pain) to 10 (most intense pain imaginable). Two items related to temporal pain assessed on 5-point scales.|Baseline Visit|Intention to treat (ITT).||units on a scale||Standard Deviation|Mean
802700|NCT00983385|Secondary|painDETECT Assessment for Participants at End of the Maintenance Period|"The baseline painDETECT score was reassessed at the end of Week 12.
It is a participant completed questionnaire. A total score is calculated. Participants with a score between 0 and 12 are scored as being negative (no neuropathic pain component). Value between 19 and 38 as being positive (presence of neuropathic component). Values from 13 to 18 are scored as being unclear."|End of Week 12|Intention to treat (ITT).||units on a scale||Standard Deviation|Mean
802701|NCT00983385|Secondary|painDETECT Assessment for Participants at End of Titration and Optimal Dose Period|"The baseline painDETECT score was reassessed at the end of Week 6.
It is a participant completed questionnaire. A total score is calculated. Participants with a score between 0 and 12 are scored as being negative (no neuropathic pain component). Value between 19 and 38 as being positive (presence of neuropathic component). Values from 13 to 18 are scored as being unclear."|End of Week 6|Intention to treat (ITT).||units on a scale||Standard Deviation|Mean
802702|NCT00983385|Secondary|painDETECT Assessment at Baseline|"The painDETECT questionnaire was used to determine the possibility of the presence of a neuropathic pain component. It is a participant completed questionnaire. A total score is calculated. Participants with a score between 0 and 12 are scored as being negative (no neuropathic pain component). Value between 19 and 38 as being positive (presence of neuropathic component). Values from 13 to 18 are scored as being unclear."|Baseline|Intention to treat (ITT).||units on a scale||Standard Deviation|Mean
802703|NCT00983385|Secondary|Change in the Health Survey Scores Form (SF-36) at End of Maintenance Period|The Scores Form 36 (SF-36) includes several brief board questions on 8 aspects, (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. A higher score indicates an improvement in health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state. A positive mean value indicates an improvement from baseline.|Baseline; End of Week 12 (12 weeks)|||Units on a scale||Standard Deviation|Mean
802704|NCT00983385|Secondary|Change in the Health Survey Scores Form (SF-36) at End of Titration and Optimal Dose Period|The Scores Form 36 (SF-36) includes several brief board questions on 8 aspects, (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. A higher score indicates an improvement in health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state. A positive mean value indicates an improvement from baseline.|Baseline; End of Week 6 (6 weeks)|Intention to treat (ITT)||Units on a scale||Standard Deviation|Mean
802705|NCT00983385|Secondary|Patient Global Impression of Change at End of the Maintenance Period|In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant is requested to choose one of seven categories. Scores range from very much improved to very much worse.|Baseline; End of Week 12 (12 weeks)|Intention to treat (ITT).||participants|||Number
802706|NCT00983385|Secondary|Patient Global Impression of Change at End of Titration and Optimal Dose Period|In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant is requested to choose one of seven categories. Scores range from very much improved to very much worse.|Baseline; End of Week 6 (6 Weeks)|Intention to treat (ITT).||participants|||Number
802707|NCT00983385|Primary|The Primary Endpoint is Defined as the Change of the Average Pain Intensity Score on an 11-point NRS-3 at Week 6 From Week -1 (Baseline).|"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. The value indicates the change from the baseline participant assessment on the 0 to 10 scale. A negative value indicates a reduction in pain intensity."|Baseline; End of Week 6 (6 Weeks)|Intention to treat. Last Observation Carried Forward (LOCF)||Units on a scale||Standard Deviation|Mean
802708|NCT00983437|Secondary|Change From Baseline in the Medical Outcomes Study 6-Item Cognitive Functioning Scale (MOS-CF6) Total Score at Months 3, 6, 9, and Endpoint (Month 12 or Last Postbaseline Observation)|The MOS-CF 6 is an instrument to assess patient self-reported cognitive function. Items were selected to cover 6 relevant aspects of cognitive functioning as follows: confusion, concentration/thinking, attention, memory, reasoning, problem solving, and processing speed. The CF 6-item responses include 6 choices, ranging from “none of the time” to “all of the time.” The CF-6 is scored by summing responses across the 6 items and converting the total to a 0- to 100-point scale, with higher scores indicating better cognitive functioning. Baseline was defined as the baseline value from the double-blind study C10953/3067/ES/MN (NCT00893789) from which the participants entered into this open-label study.|Baseline, Months 3, 6, 9, and 12 (or last postbaseline observation)|Changes from baseline in MOS-CF6 total score were not summarized. This assessment was not performed in study C10953/3067/ES/MN (NCT00893789); therefore, the data obtained at screening for the current study would represent true baseline data only for new participants, of which there were none.|||||
802709|NCT00983437|Primary|Change From Baseline in the Total Score From the Self-Reported Hamilton Depression Rating Scale, 6 Item Version (S-HAM-D6) at Week 2, Months 1, 2, 3, 6, 9, and Endpoint (Month 12, or Last Postbaseline Observation)|"The self-reported S-HAM-D6 is a validated scale developed from the core depressive items of the 17 Item Hamilton Depression Inventory (HAM-D17). The HAM-D6 (Items 1, 2, 7, 8, 10, 13 from the 17-item HAMD) evaluates core symptoms of Major Depressive Disorder (MDD). The assessment consists of 6 items representing depressed mood, guilt, work and activities, retardation, psychic anxiety, and general somatic symptoms. Each item is evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). Total scores range from 0 (normal) to 22 (severe). Scores greater than 12 indicate moderate to severe depression. Baseline was defined as the baseline value from the double-blind study C10953/3067/ES/MN (NCT00893789) from which the participants entered into this open-label study."|Baseline, Week 2, Months 1, 2, 3, 6, 9, and Endpoint (Month 12, or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.|Participants in the Safety Analysis Set with a Baseline value; n=number of participants with baseline and postbaseline value at given time point.||units on a scale||Standard Deviation|Mean
802710|NCT00983437|Primary|"Number of Participants Answering Yes to Any Question on the Columbia-Suicide Severity Rating Scale Since Last Visit Version (C-SSRS SLV) at Week 2, Months 1, 2, 3, 6, 9, and Endpoint (Month 12, or Last Postbaseline Observation)"|The percentage of participants answering 'yes' to any of the 9 yes/no questions about suicidal behaviors, ideations, and acts at given time points are presented. The C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors since last visit (SLV). Questions included the presence (yes) or absence (no) of the following: a wish to be dead; nonspecific active suicidal thoughts; actual suicide attempt; non-suicidal self-injurious behavior; interrupted attempt; aborted attempt; suicidal behavior; preparatory suicidal acts or behavior; and completed suicide.|Week 2, Months 1, 2, 3, 6, 9, and Endpoint (Month 12, or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.|Safety Analysis Set; n=number of participants with nonmissing value at given time point.||participants|||Number
802711|NCT00983437|Primary|Safety and Tolerability: Physical Examination Findings Shifts From Baseline to Endpoint (Month 12 or Last Postbaseline Observation)|Number of participants with shifts from normal/abnormal physical examination findings at baseline (BL) to (→) normal/abnormal findings at endpoint (EP). Shifts (normal and abnormal) from baseline to endpoint are summarized using participant counts for each physical examination category. A newly diagnosed finding was defined as being normal or missing at baseline and abnormal at least once during the study. Any physical examination finding that was judged by the investigator as a clinically significant change (worsening) compared to a baseline value was considered an adverse event. HEENT= head, eyes, ears, nose, throat. Baseline was defined as the baseline value from the double-blind study C10953/3067/ES/MN (NCT00893789) from which the participants entered into this open-label study.|Baseline through Endpoint (Month 12 or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.|Safety Analysis Set; only those participants with both baseline and endpoint physical examination findings are summarized.||participants|||Number
802986|NCT00988442|Secondary|Number of Participants With Premature Antiretroviral Therapy (ART) Regimen Discontinuation|Number of premature ART regimen discontinuations, defined as the first substitution, subtraction, or addition of one or more ARVs made to the initial study regimen.|From study entry to Week 72|All participants with available ART data.||participants|||Number
802712|NCT00983437|Primary|Safety and Tolerability: Electrocardiogram (ECG) Findings Shifts From Baseline to Overall|Number of participants with shifts from normal/abnormal 12-lead ECG findings at baseline (BL) to (→) normal/abnormal findings overall are presented. For overall, the worst postbaseline finding (the abnormal finding if there are both normal and abnormal findings) for the participant between baseline and endpoint (defined as last postbaseline observation, up to Week 12) is summarized. Any ECG finding that was judged by the investigator as a clinically meaningful change (worsening) compared to baseline was recorded as an adverse event. Baseline was defined as the baseline value from the double-blind study C10953/3067/ES/MN (NCT00893789) from which the participants entered into this open-label study.|Baseline through Endpoint (Month 12 or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.|Safety Analysis Set; only those participants with both baseline and endpoint ECG findings are summarized.||participants|||Number
802713|NCT00983437|Primary|Safety and Tolerability: Number of Participants With Notable Blood Pressure Values Per World Health Organization Criteria|Criteria for World Health Organization (WHO) notable blood pressure (BP) values: systolic blood pressure ≥140 mm Hg plus increase of ≥10% from baseline; diastolic blood pressure ≥90 mm Hg plus increase of ≥10% from baseline. Baseline was defined as the baseline value from the double-blind study C10953/3067/ES/MN (NCT00893789) from which the participants entered into this open-label study.|Baseline, Week 2, Months 1, 2, 3, 6, 9, and 12 (or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.|Safety Analysis Set; participants with a baseline and postbaseline value.||participants|||Number
802714|NCT00983437|Primary|Safety and Tolerability: Number of Participants With Clinically Significant Abnormal Urinalysis Results|Criteria for clinically significant abnormal urinalysis values: blood (hemoglobin) ≥2 unit increase from baseline; glucose ≥2 unit increase from baseline; ketones ≥2 unit increase from baseline; total protein ≥2 unit increase from baseline. Baseline was defined as the baseline value from the double-blind study C10953/3067/ES/MN (NCT00893789) from which the participants entered into this open-label study.|Baseline, Months 6 and 12 (or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.|Safety Analysis Set||participants|||Number
802715|NCT00983437|Primary|Safety and Tolerability: Number of Participants With Clinically Significant Abnormal Hematology Test Results|Criteria for clinically significant abnormal hematology values: hematocrit, men <0.37 L/L or women <0.32 L/L; hemoglobin, men ≤115 g/L or women ≤95 g/L; white blood cell (WBC) count ≤3x10^9/L or ≥20x10^9/L; eosinophils ≥10%; absolute neutrophil count (ANC) ≤1x10^9/L; platelet count ≤75x10^9/L or ≥700x10^9/L.|Assessed at Screening, Months 6 and 12 (or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.|Safety Analysis Set||participants|||Number
802716|NCT00983437|Secondary|Change From Baseline in Traumatic Brain Injury - Work Instability Scale (TBI-WIS) Score Values at Months 3, 6, 9, and Endpoint (Month 12 or Last Postbaseline Observation)|"The TBI-WIS is a validated participant-rated instrument for assessing a participant's functional ability after TBI and the functional demands of their job. The assessment consists of 36 questions to which the participant responded with a true or not true answer. To score the questionnaire, the number of true responses is counted: if < 2, the risk for work instability is low; 2 to 23, the risk is medium; and >23, the risk is high. Score range is 0 (lowest risk for work instability) to 36 (highest risk for work instability). Baseline was defined as the baseline value from the double-blind study C10953/3067/ES/MN (NCT00893789) from which the participants entered into this open-label study."|Baseline, Months 3, 6, 9, and Endpoint (Month 12 or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.|Participants in the Full Analysis Set (those in the Safety Analysis Set with at least 1 post-baseline efficacy assessment) with a TBI-WIS score at baseline; n=number of participants with value at baseline and given time point.||units on a scale||Standard Deviation|Mean
802717|NCT00983437|Secondary|Percentage of Participants With Improvement on the Clinical Global Impression of Severity of Illness (CGI-S) at Week 2 and Months 1, 2, 3, 6, 9, and Endpoint (Month 12 or Last Postbaseline Observation)|The clinician's rating of disease severity as assessed by the Clinical Global Impression of Severity (CGI-S). CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill); the 7 categories include the following: normal-shows no sign of illness, borderline ill, mildly (slightly) ill, moderately ill, markedly ill, severely ill, and among the most extremely ill. Improvement is defined as at least 1 point improvement from baseline. Baseline was defined as the baseline value from the double-blind study C10953/3067/ES/MN (NCT00893789) from which the participants entered into this open-label study.|Week 2 and Months 1, 2, 3, 6, 9, and Endpoint (Month 12 or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.|Full Analysis Set = participants in the Safety Analysis Set who had at least 1 post-baseline efficacy assessment; n=number of participants with value at baseline and given time point.||percentage of participants|||Number
802718|NCT00983437|Secondary|Change From Baseline in Clinical Global Impression of Severity of Illness (CGI-S) at Week 2 and Months 1, 2, 3, 6, 9, and Endpoint (Month 12 or Last Postbaseline Observation)|The clinician's rating of disease severity as assessed by the Clinical Global Impression of Severity (CGI-S). CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill); the 7 categories include the following: normal-shows no sign of illness, borderline ill, mildly (slightly) ill, moderately ill, markedly ill, severely ill, and among the most extremely ill. Baseline was defined as the baseline value from the double-blind study C10953/3067/ES/MN (NCT00893789) from which the participants entered into this open-label study.|Baseline, Week 2 and Months 1, 2, 3, 6, 9, and Endpoint (Month 12 or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.|Full Analysis Set = participants in the Safety Analysis Set who had at least 1 post-baseline efficacy assessment; n=number of participants with value at baseline and given time point.||units on a scale||Standard Deviation|Mean
802768|NCT00983905|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the theophylline plasma concentration versus time curve, from time 0 to the time of the last measurable theophylline concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic blood samples drawn within 1 hour prior to theophylline dosing (0 hour) on Days 1 and 19, then at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours after theophylline dose administration|||µg-hr/mL||Standard Deviation|Mean
812460|NCT01070784|Primary|Clinical Laboratory Test: Clinical Chemistry- S-Sodium|Change from baseline|Baseline and 52 week after|||mEq/L||Standard Deviation|Mean
802719|NCT00983437|Secondary|Change From Baseline in Epworth Sleepiness Scale (ESS) at Week 2 and Months 1, 2, 3, 6, 9, and Endpoint (Month 12 or Last Postbaseline Observation)|The participant's evaluation of excessive daytime sleepiness was measured by the ESS. The ESS score is based on responses to questions referring to 8 everyday situations (eg, sitting and reading, talking to someone, being stopped in traffic) and reflects a patient's propensity to fall asleep in those situations. The ESS score is derived from the sum of the values from questions corresponding to the 8 situations. Scores for the ESS range from 0 to 24, with a higher score indicating a greater daytime sleepiness. This test was self-administered. Baseline was defined as the baseline value from the double-blind study C10953/3067/ES/MN (NCT00893789) from which the participants entered into this open-label study.|Baseline, Week 2 and Months 1, 2, 3, 6, 9, and Endpoint (Month 12 or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.|Full Analysis Set = participants in the Safety Analysis Set who had at least 1 post-baseline efficacy assessment; n=number of participants with value at baseline and given time point.||units on a scale||Standard Deviation|Mean
802720|NCT00983437|Primary|Safety and Tolerability: Number of Participants With Clinically Significant Abnormal Vital Signs Measurements|Criteria for clinically significant abnormal vital signs values: pulse, ≥120 beats per minute (bpm) and increase from baseline of ≥15 bpm or ≤50 bpm and decrease from baseline of ≥15 bpm; systolic blood pressure, ≥180 mm Hg and increase from baseline of ≥20 mm Hg or ≤90 mm Hg and decrease from baseline of ≥20 mm Hg; diastolic blood pressure, ≥105 mm Hg and increase from baseline of ≥15 mm Hg or ≤50 mm Hg and decrease from baseline of ≥15 mm Hg; temperature >38.3º celsius (C) and change from baseline of ≥1.1°C. Baseline was defined as the baseline value from the double-blind study C10953/3067/ES/MN (NCT00893789) from which the participants entered into this open-label study.|Baseline, Week 2, Months 1, 2, 3, 6, 9, and 12 (or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.|Safety Analysis Set||participants|||Number
802721|NCT00983437|Primary|Safety and Tolerability: Number of Participants With Clinically Significant Serum Chemistry Test Results|Criteria for clinically significant abnormal serum chemistry values: alanine aminotransferase (ALT) ≥3x upper limit of normal (ULN); aspartate aminotransferase (AST) ≥3x ULN; alkaline phosphatase ≥3x ULN; gamma-glutamyl transpeptidase (GGT) ≥3x ULN; lactate dehydrogenase (LDH) ≥3x ULN; blood urea nitrogen (BUN) ≥10.71 mmol/L; creatinine ≥177 μmol/L; uric acid, men ≥625 μmol/L, women ≥506 μmol/L; bilirubin (total) ≥34.2 μmol/L.|Assessed at Screening, Months 6 and 12 (or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.|Participants in the Safety Analysis Set who had a baseline and at least one post-baseline value.||participants|||Number
802722|NCT00983437|Primary|Safety and Tolerability: Concomitant Medication Usage In Participants Throughout the Study|Therapeutic classification of concomitant medications used by participants throughout the study. Participants are counted only once in each therapeutic class category.|Assessed from Screening through end of treatment; median (full range) of treatment was 98 (5.0 to 326.0) days.|Safety Analysis Set||participants|||Number
802723|NCT00983437|Primary|Safety and Tolerability: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations Due to AEs|AE=any untoward medical occurrence that develops or worsens in severity during the conduct of the clinical study of a pharmaceutical product and does not necessarily have a causal relationship to the study drug. SAE=any AE that resulted in any of the following: death; a life-threatening adverse event; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; a congenital anomaly or birth defect; an important medical event that required medical intervention to prevent 1 of the outcomes listed in this definition. Treatment-related AEs=definite, probable, possible, or missing relationship to study drug. Protocol-defined AEs=treatment-emergent adverse events associated with skin rash, hypersensitivity reaction, emergent suicidal ideation or suicide attempt, depression, psychosis, and seizure or suspected seizure were considered to be of potential clinical importance. DB=double-blind portion of the study (NCT00893789).|Assessed from Screening through end of treatment; median (full range) of treatment was 98 (5.0 to 326.0) days.|Safety Analysis Set (study participants who received at least 1 dose of study drug)||participants|||Number
802724|NCT00983476|Secondary|BMI|BMI = (weight in pounds * 703)/ height in inches²|12 months|All randomized participants who received the intervention as randomized and who completed a 12 month follow-up weight were included in this summary. Receiving the intervention as randomized was minimally defined as participating in one or more modules/sessions (WebMOVE or MOVE SMI) or receipt of the educational handout (Usual Care).||kg/meter square||Standard Deviation|Mean
802725|NCT00983476|Secondary|BMI|BMI = (weight in pounds * 703)/ height in inches²|9 months|All randomized participants who received the intervention as randomized and who completed a 9 month follow-up weight were included in this summary. Receiving the intervention as randomized was minimally defined as participating in one or more modules/sessions (WebMOVE or MOVE SMI) or receipt of the educational handout (Usual Care).||kg/meter squared||Standard Deviation|Mean
802726|NCT00983476|Secondary|Quality of Life: Sexual Life|"Impact of Weight on Quality of Life (IWQOL; Kolotkin et al 2008): Sexual Life subscale.
The Sexual Life subscale includes survey items 19-22, which are each scored on a scale from 1-5. The subscale score is an average of the scores on those items. Lower scores indicate greater impairment. Range in the subscale scores can be from 1 (min) to 5 (max)."|6 months|All randomized participants who received the intervention as randomized and completed this measure at 6 months were included in the analysis. Receiving the intervention as randomized was minimally defined as participating in one or more modules/sessions (WebMOVE or MOVE SMI) or receipt of the educational handout (Usual Care).||units on a scale||Standard Error|Mean
802727|NCT00983476|Secondary|Quality of Life: Self-Esteem|"Impact of Weight on Quality of Life (IWQOL; Kolotkin et al. 2008): Self-Esteem subscale.
The Self-Esteem subscale includes survey items 12-18, which are each scored on a scale from 1-5. The subscale score is an average of the scores on those items. Lower scores indicate greater impairment. Range in the subscale scores can be from 1 (min) to 5 (max)."|6 months|All randomized participants who received the intervention as randomized and had data at 6 months were included in the analyses. Receiving the intervention as randomized was minimally defined as participating in one or more modules/sessions (WebMOVE or MOVE SMI) or receipt of the educational handout (Usual Care).||units on a scale||Standard Error|Mean
805177|NCT00995566|Primary|Concomitant Medications|Number of participants with concomitant medication usage reported by drug categories.|Baseline, monthly up to 1 year|Data not summarized due to the small number of participants in database.||participants|||Number
802728|NCT00983476|Secondary|Quality of Life: Physical Functioning|"Impact of Weight on Quality of Life (IWQOL; Kolotkin et al., 2008): Physical Functioning subscale.
The Physical Functioning subscale includes survey items 1-11, which are each scored on a scale from 1-5. The subscale score is an average of the scores on those items. Lower scores indicate greater impairment. Range in the subscale scores can be from 1 (min) to 5 (max)."|6 months|All randomized participants who received the intervention as randomized and completed this measure at 6 months were included in the analysis. Receiving the intervention as randomized was minimally defined as participating in one or more modules/sessions (WebMOVE or MOVE SMI) or receipt of the educational handout (Usual Care).||units on a scale||Standard Error|Mean
802729|NCT00983476|Primary|Dietary Habits: Reducing Fat (Self-efficacy, Motivation, Readiness to Change)|"Self-Efficacy and Eating Habits Survey (Sallis et al., 1988): Reducing Fat Factor.
The Reducing Fat factor includes survey items 16-20, which are each scored on a scale from 1-5. The factor score is an average of the scores on those items. Higher scores indicate more confidence in making the change in reducing fat in the diet. Range in the factor scores can be from 1 (min) to 5 (max)."|6 months|All randomized participants who received the intervention as randomized and completed this measure at 6 months were included in the analysis. Receiving the intervention as randomized was minimally defined as participating in one or more modules/sessions (WebMOVE or MOVE SMI) or receipt of the educational handout (Usual Care).||units on a scale||Standard Error|Mean
802730|NCT00983476|Primary|Dietary Habits: Reducing Calories (Self-efficacy, Motivation, Readiness to Change)|"Self-Efficacy and Eating Habits Survey (Sallis et al., 1988): Reducing Calories Factor.
The Reducing Calories factor includes survey items 6-10, which are each scored on a scale from 1-5. The factor score is an average of the scores on those items. Higher scores indicate more confidence in making the change in reducing calories. Range in the factor scores can be from 1 (min) to 5 (max)."|6 months|All randomized participants who received the intervention as randomized and completed this measure at 6 months were included in the analysis. Receiving the intervention as randomized was minimally defined as participating in one or more modules/sessions (WebMOVE or MOVE SMI) or receipt of the educational handout (Usual Care).||units on a scale||Standard Error|Mean
802731|NCT00983476|Primary|Body Mass Index (BMI) Within Obese Sample|BMI = (weight in pounds * 703)/ (height in inches²); obese defined as BMI > 30|6 months|Analyses excluded participants with BMI of 28-29.9 (overweight) at baseline, leaving only those with BMI >= 30 at baseline who received the intervention as randomized.||kilogram/(meters squared)||Standard Error|Mean
802732|NCT00983476|Primary|Body Mass Index (BMI)|BMI = (weight in pounds * 703)/ (height in inches²) at 6 month follow-up as predicted by the mixed model described in Statistical Analysis 1|6 months|All randomized participants who received any intervention as randomized were included in the primary analyses, regardless of the number of assessments completed. Receiving intervention as randomized was defined as participating in one or more modules/sessions (WebMOVE or MOVE SMI) or receipt of the educational handout (Usual Care).||kg/(meters squared)||Standard Error|Mean
802733|NCT00983489|Primary|Exclusive Breast Feeding Rate at Six Weeks Postnatal Age||6 weeks|||Participants|||Number
802734|NCT00983515|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable colchicine plasma concentration to the elimination rate constant.|serial pharmacokinetic blood samples drawn within 1 hour prior to colchicine dosing (0 hour) on Days 1 and 19, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after colchicine dose administration|||pg-hr/mL||Standard Deviation|Mean
802735|NCT00983515|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable colchicine concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic blood samples drawn within 1 hour prior to colchicine dosing (0 hour) on Days 1 and 19, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after colchicine dose administration|||pg-hr/mL||Standard Deviation|Mean
802736|NCT00983515|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that colchicine reaches in the plasma.|serial pharmacokinetic blood samples drawn within 1 hour prior to colchicine dosing (0 hour) on Days 1 and 19, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after colchicine dose administration|||pg/mL||Standard Deviation|Mean
802737|NCT00983541|Secondary|Evaluate Rate of Distant Mets Following Gemcitabine and 5-FU With Radiation Therapy in Patients With HCC||9 months|Trial did not meet accrual goals so analysis was not performed|||||
802738|NCT00983541|Secondary|Evaluate Local Control Rate Following Gemcitabine and 5-FU With Radiation Therapy in Patients With HCC||9 months|Trial did not meet accrual goals so analysis was not performed|||||
802739|NCT00983541|Secondary|Evaluate Tumor Response Rate Following Gemcitabine and 5-FU With Radiation Therapy in Patients With HCC||9 months.|Trial did not meet accrual goals so analysis was not performed|||||
802740|NCT00983541|Secondary|Evaluate Progression Free Survival Rate Following Gemcitabine and 5-FU With Radiation Therapy in Patients With HCC||9 months|Trial did not meet accrual goals so analysis was not performed|||||
802741|NCT00983541|Secondary|Evaluate the Rate at Which Patients With Unresectable Extrahepatic Cholangiocarcinoma Become Resectable Following Gemcitabine and Radiation Therapy.||9 months|Trial did not meet accrual goals so analysis was not performed|||||
802742|NCT00983541|Secondary|Evaluate Overall Survival Ratefollowing Gemcitabine and 5-FU With Radiation Therapy in Patients With HCC||9 months|Trial did not meet accrual goals so analysis was not performed|||||
802743|NCT00983541|Primary|Number of Participants Experiencing Toxicity Treated With Gemcitabine Every Two Weeks & 5-FU Given Concurrently With External Beam Radiation Therapy , Followed by Brachytherapy or SBRT Boost.||Toxicity was assessed for each patient over the course of the study treatment and follow-up stage which together lasted 9 months. Only one patient was enrolled.|||participants|||Number
802744|NCT00983645|Secondary|Lipid Levels||6 months post-transplant|Data cannot be located for analysis.|||||
802745|NCT00983645|Secondary|Post-transplant Diabetes Mellitus||6 months post-transplant|Data cannot be located for analysis.|||||
802746|NCT00983645|Secondary|Renal Function||6 months post-transplant|Data cannot be located for analysis.|||||
802747|NCT00983645|Primary|Rejection||6 months post-transplant|Data cannot be located for analysis.|||||
802748|NCT00983749|Primary|Safety (Including Endpoints Such an Increase NIHSS During or Immediately After ECP, and Acute Hemorrhage on Repeating Imaging, Serious Adverse Events Related to ECP, Mortality)|Safety was evaluated by the incidence of serious adverse events (SAEs) or acute neurological deterioration in relation to the study device and/or procedures at 30 days, the incidence of acute symptomatic hemorrhage on repeat imaging at 24 hours, the incidence of all adverse events (AEs) in the first 48 hours, and mortality at 30 days. The National Institutes of Health Stroke Scale (NIHSS) is a stroke severity scale, based on examination, that goes from 0 (no deficit) to a maximum of 42. Acute neurological deterioration – which was captured as a serious adverse event - was defined as a ≥4-point increase on the NIHSS, or a ≥2-point decline in level of consciousness item 1a on the NIHSS, or a new neurological deficit, or clinically significant worsening of motor function lasting more than 8 hours and attributable to a neurological entity. Symptomatic intracranial hemorrhage was defined as new hemorrhage on CT that was associated with acute neurological deterioration.|30 days|||participants|||Number
802749|NCT00983749|Primary|Feasibility and Tolerability of External Counterpulsation|The first primary outcome measure was tolerability and feasibility. Tolerance was defined as the absence of any indications to stop the procedure or reduce the pressure to a non-therapeutic level. Feasibility was defined in the full-pressure group as the sustained (at least 30 minutes) tolerance of any pressure capable of causing a 15% augmentation of MFV in 90% of subjects, and defined in the sham-pressure group as the sustained tolerance of the sham pressure in all subjects.|During one hour of treatment|||participants|||Number
802750|NCT00983801|Secondary|Number of Participants With Serum Chemistry Abnormalities|Grading: NCI CTCAE, Version 3.0. GR1=mild, GR2=moderate, GR3=severe, GR4=life threatening or disabling. Normal ranges provided by local laboratory and may also vary by age and sex. Alkaline phosphatase (ALP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST): GR1=>ULN-2.5*ULN; GR2=>2.5-5.0*ULN; GR3=>5.0-20.0*ULN; GR4=>20.0*ULN. Total bilirubin: GR1=>ULN-1.5*ULN, GR2=>1.5-3.0*ULN, GR3=>3-10*ULN, GR4=>10*ULN. Creatinine: GR1=>ULN-1.5*ULN, GR2=>1.5-3.0*ULN, GR3=>3.0-6.0*ULN, GR4=>6.0*ULN. ULN=upper limit of normal.|Assessed within 2 weeks of first dose and every 3 weeks before therapy dose (maximum time that any participant was on therapy was 30 weeks).|Participants who received at least 1 dose of ixabepilone. n=number of participants with at least 1 measurement available during the study therapy period.||participants|||Number
802751|NCT00983801|Secondary|Number of Participants With Hematology Abnormalities|Grading: NCI CTCAE, Version 3.0. GR1=mild, GR2=moderate, GR3=severe, GR4=life threatening or disabling. Normal ranges provided by local laboratory and may also vary by age and sex. White blood cell (WBC):GR1=<LLN-3.0*10^9/L; GR2=<3.0-2.0*10^9/L; GR3=<2.0-1.0*10^9/L; GR4=<1.0*10^9/L. Absolute Neutrophil Count (ANC):GR1=<LLN-1.5*10^9 /L; GR2=<1.5-1.0*10^9/L; GR3=<1.0-0.5*10^9/L; GR4=<0.5*10^9/L. Platelets:GR1=<LLN-75.0*10^9/L; GR2=<75.0-50.0*10^9/L; GR3=<50.0-25.0*10^9/L, GR4=<25.0*10^9/L. Hemoglobin:GR1=<LLN-10.0g/dL; GR2=<10.0-8.0g/dL; GR3=<8.0-6.5g/dL, GR4=<6.5g/dL. LLN=lower limit of normal.|Assessed once every week for first 3 weeks, as clinically indicated, start of each 3 week cycle (maximum time that any participant was on therapy was 30 weeks).|Participants who received at least 1 dose of ixabepilone and had at least one measurement available during the study therapy period.||participants|||Number
802752|NCT00983801|Other Pre-specified|Number of Participants With Best Response as Assessed With Modified RECIST|Best overall response that any participant can have is the best response recorded from the start of treatment until disease progression or recurrence (taking the smallest measurement recorded since the start of treatment as reference). PR: At least 30% reduction from baseline in the sum of the LD of all target lesions. PR criteria should be met again after 4 weeks and before 6 weeks. Stable disease (SD)=Neither PR or progressive disease (PD) are met, taking the smallest sum of the LD recorded at baseline as reference. Refer to outcome measure 4 for definition of PD.|During treatment, assessed every 6 weeks (± 1 week) starting from the 1st dose of therapy until disease progression, or development of intolerable toxicity, for a maximum of 8 cycles (to a maximum follow up for tumor response of 30 weeks)|Response-evaluable participants: Participants who received at least 1 dose of ixabepilone with measurable disease at baseline and right cancer diagnosis (presence of histologic or cytologic diagnosis of advanced or metastatic adenocarcinoma originating in the stomach or gastroesophageal junction).||participants|||Number
802753|NCT00983801|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs), and AEs Leading to Discontinuation of Study Therapy Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0|AE: New untoward medical occurrence or worsening of a preexisting medical condition that does not have causal relationship with this treatment. SAE: Untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, drug dependency/abuse; life-threatening, an important medical event, a congenital anomaly/birth defect; requires inpatient hospitalization/prolongs existing hospitalization. Grade (GR) 3=Severe; and GR4=Life-threatening or disabling. DR=Drug-related. Any Peripheral Neuropathy includes peripheral sensory and motor neuropathies, including muscle weakness, and hypoaesthesia.|Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 10.5 weeks (range: 3 to 30 weeks)|Participants who received at least 1 dose of study therapy.||participants|||Number
802754|NCT00983801|Secondary|Percentage of Participants With Disease Control Rate|Defined as percentage of participants whose best response was PR, CR, or SD as determined by the investigator. SD=Neither PR or PD are met, taking the smallest sum of the LD recorded at baseline as reference. Refer to outcome measure 1 for definition of CR or PR and refer to outcome measure 4 for definition of PD. A 2-sided 95% CI was computed using Clopper-Pearson method.|During treatment, assessed every 6 weeks (± 1 week) starting from the 1st dose of therapy until disease progression, or development of intolerable toxicity, for a maximum of 8 cycles (maximum time that any participant was on therapy was 30 weeks)|Response-evaluable participants: Participants who received at least 1 dose of ixabepilone with measurable disease at baseline and right cancer diagnosis (presence of histologic or cytologic diagnosis of advanced or metastatic adenocarcinoma originating in the stomach or gastroesophageal junction).||percentage of participants||95% Confidence Interval|Number
802769|NCT00983905|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that theophylline drug reaches in the plasma.|serial pharmacokinetic blood samples drawn within 1 hour prior to theophylline dosing (0 hour) on Days 1 and 19, then at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours after theophylline dose administration|||µg/mL||Standard Deviation|Mean
802770|NCT00983918|Secondary|Analgesic Consumption||24 hours||||||
802755|NCT00983801|Secondary|Progression Free Survival (PFS)|PFS=the time interval from date of randomization to the earliest (first) progression or date of death. Participants who progressed or died were counted as events. PD=≥20% increase in sum of LD of target lesions and an absolute increase ≥5 mm in tumor size in reference to the smallest sum LD recorded at or following baseline or the appearance of one or more new lesions or unequivocal progression of existing non-target lesions. Estimated using the Kaplan-Meier product-limit method for all treated participants and a 2-sided 95% CI for the median PFS was computed by Brookmeyer and Crowley method).|From the date of initiation of study therapy to the date of progression (up to 8.1 months).|Participants who received at least 1 dose of ixabepilone. Participants who died without reporting prior progression were considered to have progressed on their death day. Participants who did not progress or die were censored on their last tumor assessment day. Participants without on-study tumor assessments were censored at start date of therapy.||months||95% Confidence Interval|Median
802756|NCT00983801|Secondary|Duration of Response|Defined as the period in months from the time measurement criteria are first met for PR or CR until the first date of documented PD or death. Refer to outcome measure 1 for CR and PR. PD=≥20% increase in the sum of LD of target lesions and an absolute increase of at least 5 mm of tumor size in reference to the smallest sum LD recorded at or following baseline or the appearance of one or more new lesions or unequivocal progression of existing non-target lesions. Estimated by Kaplan-Meier product limit method and a 2-sided 95% CI for median duration was computed by Brookmeyer and Crowley method.|From the date of first PR or CR assessment to the date of progression, death, or last tumor assessment (maximum: 4.1 months)|Participants who received at least 1 dose of ixabepilone and had either CR or PR. Participants who neither relapsed nor died were censored on the date of their last tumor assessment.||months||95% Confidence Interval|Median
802757|NCT00983801|Secondary|Time to Response|Time to response is defined as the time in weeks from the first dose of study therapy until measurement criteria are first met for PR or CR (whichever status is recorded first). CR: Disappearance of all evidence of target and non-target lesions. In case of lymph node lesions, the short axis of all nodes should measure <10 mm. PR: At least 30% reduction from baseline in the sum of the LD of all target lesions. CR and PR criteria should be met again after 4 weeks and before 6 weeks of initial assessment.|Assessed every 6 weeks (± 1 week) starting from the first dose of study therapy until CR or PR (up to 12.1 weeks.)|Participants who received at least 1 dose of study therapy and had a response of either CR or PR.||weeks||Full Range|Median
802758|NCT00983801|Primary|Percentage of Participants With Overall Response Rate (ORR) Based on Modified Response Evaluation Criteria in Solid Tumors (RECIST)|Percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) according to modified RECIST, as determined by investigator. CR: Disappearance of all evidence of target and non-target lesions. In case of lymph node, the lesions short axis of all nodes measuring <10 mm. PR: At least 30% reduction from baseline in the sum of the longest diameter (LD) of all target lesions. CR and PR criteria should be met again after 4 weeks and before 6 weeks after initial assessment. A 2-sided confidence interval (CI) was computed using Clopper-Pearson method.|During treatment, assessed every 6 weeks (± 1 week) starting from the 1st dose of therapy until disease progression, or development of intolerable toxicity, for a maximum of 8 cycles (maximum time that any participant was on therapy was 30 weeks)|Response-evaluable participants: Participants who received at least 1 dose of ixabepilone with measurable disease at baseline and right cancer diagnosis (presence of histologic or cytologic diagnosis of advanced or metastatic adenocarcinoma originating in the stomach or gastroesophageal junction).||percentage of participants||95% Confidence Interval|Number
802759|NCT00983827|Primary|Safety|Number of procedure related adverse events that occurred during study.|16 weeks|||adverse events|||Number
802760|NCT00983853|Secondary|Median Trough Plasma Concentration (Ctrough) Ratios of Atazanavir (ATZ), Ritonavir, and Tenofovir (Part B Only, Subjects on ATV-based HAART)|Ctrough of HAART medication with telaprevir (test) and without telaprevir (reference)|through 12 weeks after first dose of study drug|subjects with available concentration data||ratio (test/reference)||Full Range|Median
802761|NCT00983853|Secondary|Median Trough Plasma Concentration (Ctrough) Ratios of Efavirenz and Tenofovir (Part B Only, Subjects on EFV-based HAART)|Ctrough ratio of HAART medication with telaprevir (test) and without telaprevir (reference)|through 12 weeks after first dose of study drug|subjects with available concentration data||ratio (test/reference)||Full Range|Median
802762|NCT00983853|Secondary|Effect of Efavirenz-based (EFV) and Atazanavir-based (ATV/r) Highly Active Antiretroviral Therapy(HAART) on Telaprevir Exposure||through 12 weeks after first dose of study drug|subjects with available plasma concentration data||ratio (test/reference)||90% Confidence Interval|Least Squares Mean
802763|NCT00983853|Secondary|Proportion of Subjects Who Have Undetectable HCV RNA 12 Weeks (SVR12) and 24 Weeks (SVR24) After Last Planned Dose of Study Treatment||12 weeks after last dose of study drug|subjects who received at least 1 dose of study drug.||participants|||Number
802764|NCT00983853|Secondary|Proportion of Subjects Achieving Undetectable HCV RNA at Week 4 and Week 12|number of subjects with undetectable HCV RNA|4 and 12 weeks after the first dose of study drug|Subjects who were randomized and received at least 1 dose of study drug||participants|||Number
802765|NCT00983853|Primary|Proportion of Subjects Achieving Undetectable HCV RNA at Week 12||12 weeks after first dose of study drug|Subjects who were randomized and received at least 1 dose of study drug||participants|||Number
802766|NCT00983892|Primary|Summed Symptom Severity|Summed severity across 8 symptoms of interest, as measured using the MD Anderson Symptom Inventory. 8 core symptoms rated by the patient on a scale of 0 to 10. These 8 symptoms were chosen based on their prevalence of 50% or greater in the population of interest. Higher scores mean WORSE or GREATER SYMPTOM BURDEN.|3 months|||units on a scale||Standard Deviation|Mean
802767|NCT00983905|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the theophylline plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable theophylline plasma concentration to the elimination rate constant.|serial pharmacokinetic blood samples drawn within 1 hour prior to theophylline dosing (0 hour) on Days 1 and 19, then at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours after theophylline dose administration|||µg-hr/mL||Standard Deviation|Mean
802771|NCT00983918|Primary|Pain Measured on Verbal Scale of 0-10, With 0 Being Absolutely no Pain, and 10 Being the Worst Pain in That Subjects Life.||24 hours|||units on a scale||Standard Deviation|Mean
802772|NCT00983931|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable colchicine plasma concentration to the elimination rate constant.|serial pharmacokinetic blood samples drawn immediately prior to colchicine dosing on Days 1 and 15, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after colchicine dose administration|||pg-hr/mL||Standard Deviation|Mean
802773|NCT00983931|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable colchicine concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic blood samples drawn immediately prior to colchicine dosing on Days 1 and 15, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after colchicine dose administration|||pg-hr/mL||Standard Deviation|Mean
802774|NCT00983931|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that colchicine reaches in the plasma.|serial pharmacokinetic blood samples drawn immediately prior to colchicine dosing on Days 1 and 15, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after colchicine dose administration|||pg/mL||Standard Deviation|Mean
802775|NCT00983957|Primary|Time of Maximum Observed Plasma Concentration of Norelgestromin|Norelgestromin was measured in plasma, using liquid chromatography-tandem mass spectrometry by a validated analytical method during the period of known analyte stability. Tmax was measured in hours (h), and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77|All participants who received the study drug.||hours||Full Range|Median
802776|NCT00983957|Primary|Area Under the Concentration-Time Curve in 1 Dosing Interval of Norelgestromin|Norelgestromin was measured in plasma, using liquid chromatography-tandem mass spectrometry by a validated analytical method during the period of known analyte stability. AUC(TAU) was measured in nanograms multiplied by hours (h) per milliliter (ng*h/mL) and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77|All participants who received the study drug.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
802777|NCT00983957|Secondary|Number of Participants Demonstrating a Clinically Meaningful Effect in ECG Parameters|The electrocardiogram (ECG) evaluations were performed within ± 15 minutes of the relative time points. ECGs were recorded after the participants were in supine position for at least 5 minutes. ECG parameters measured were: PR interval, QRS complex, QT interval and corrected QT (QTc).|Screening, Day 1, Day 67, Day 77|All participants who received at least one dose of study drug.||participants|||Number
802778|NCT00983957|Secondary|Number of Participants Demonstrating a Clinically Meaningful Effect in Vital Signs|Vital Signs were measured after the participant was seated quietly for at least 5 minutes and included systolic and diastolic blood pressure, heart rate, respiratory rate, and temperature. Baseline = Last non-missing pretreatment value.|Baseline, Day 28, Day 29, Day 67, Day 68, Day 78, Day of discharge|All participants who received at least one dose of study drug.||participants|||Number
802779|NCT00983957|Secondary|Number of Participants With Laboratory Test Abnormalities|Laboratory marked abnormalities were defined as Hematocrit (low) as <0.85*Pre-treatment (PreRx), Hemoglobin (low) as <0.85*PreRx, Aspartate Aminotransferase (AST) (high) as >1.25*PreRx if PreRx > upper limits of normal (ULN); >1.25*ULN if PreRx <=ULN; >1.25*ULN if PreRx = Missing, Blood in urine (high) as ≥2 PreRx if PreRx ≥1; ≥2 if PreRx <1; ≥2 if PreRx = Missing.|From start of treatment (Day 1) up to Day 78 or discharge|All participants who received at least one dose of study drug.||participants|||Number
802780|NCT00983957|Secondary|Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Who Died|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|For AEs from start of treatment (Day 1) up to Day 78 or discharge and for SAEs from Day 1 to 30 days after last dose of study drug|All participants who received at least one dose of study drug.||participants|||Number
802781|NCT00983957|Primary|Maximum Observed Plasma Concentration of Norelgestromin|Norelgestromin is a major active metabolite of norgestimate (NGM) which is found in Ortho Tri-Cyclen. Norelgestromin was measured in plasma, using liquid chromatography-tandem mass spectrometry by a validated analytical method during the period of known analyte stability. Cmax was measured in nanograms per milliliter (ng/mL) and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77|All participants who received the study drug.||nanogram per millilitre (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
802782|NCT00983957|Primary|Time of Maximum Observed Plasma Concentration of Ethinyl Estradiol|Ethinyl Estradiol was measured in plasma, using liquid chromatography-tandem mass spectrometry by a validated analytical method during the period of known analyte stability. Tmax was measured in hours (h), and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77|All participants who received the study drug||hours||Full Range|Median
802783|NCT00983957|Secondary|Time of Maximum Observed Plasma Concentration of Norgestrel|Norgestrel was measured in plasma, using liquid chromatography-tandem mass spectrometry by a validated analytical method during the period of known analyte stability. Tmax was measured in hours (h), and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77|All participants who received the study drug.||hours||Full Range|Median
802784|NCT00983957|Secondary|Area Under the Concentration-Time Curve in 1 Dosing Interval of Norgestrel|Norgestrel was measured in plasma, using liquid chromatography-tandem mass spectrometry by a validated analytical method during the period of known analyte stability. AUC(TAU) was measured in picograms multiplied by hours (h) per milliliter (pg*h/mL) and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77|All participants who received the study drug.||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
802785|NCT00983957|Primary|Area Under the Concentration-Time Curve (AUC) in 1 Dosing Interval of Ethinyl Estradiol|Ethinyl Estradiol was measured in plasma, using liquid chromatography-tandem mass spectrometry by a validated analytical method during the period of known analyte stability. AUC(TAU) was measured in picograms multiplied by hours (h) per milliliter (pg*h/mL) and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77|All participants who received the study drug.||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
802786|NCT00983957|Secondary|Maximum Observed Plasma Concentration of Norgestrel|Norgestrel is an NGM metabolite and was measured in plasma using liquid chromatography–mass spectrometry by a validated analytical method during the period of known analyte stability. Cmax was measured in picograms per milliliter (pg/mL) and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77|All participants who received the study drug.||pg/mL||Geometric Coefficient of Variation|Geometric Mean
802787|NCT00983957|Primary|Maximum Observed Plasma Concentration (Cmax) of Ethinyl Estradiol|Ethinyl Estradiol is an analyte of Ortho Tri-Cyclen. Ethinyl Estradiol was measured in plasma, using liquid chromatography-tandem mass spectrometry (LC-MS/MS) by a validated analytical method during the period of known analyte stability. Cmax was measured in picograms per milliliter (pg/mL) and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Days 49 and 77|All participants who received the study drug.||picogram per millilitre (pg/mL)||Geometric Coefficient of Variation|Geometric Mean
802788|NCT00983983|Primary|Tolerability|Number of participants who completed the study on their assigned study intervention.|5 months|The number of participants who received the study diet (4 participants withdrew consent prior to receiving study intervention).||participants|||Number
802789|NCT00983983|Primary|Serious Adverse Events|SAE were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|5 months|||Number of Serious Adverse Events|||Number
802790|NCT00983983|Primary|Safety Outcomes: Frequency of Adverse Events||5 months|||Total Number of Adverse Events|||Number
802791|NCT00983983|Secondary|Biomarkers of Body Composition and Lipid Metabolism||5 months follow-up||||||
802792|NCT00983983|Secondary|Rate of Change in ALSFRS-R in Units/Month|Rate of change in the ALS Functional Rating Scale-Revised, calculated in units/month. Negative numbers refer to worsening over time.|Over 5 months|||units on a scale/month||95% Confidence Interval|Mean
802793|NCT00984009|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable colchicine plasma concentration to the elimination rate constant.|serial pharmacokinetic blood samples drawn immediately prior to colchicine dosing on Days 1 and 18, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after colchicine dose administration|||pg-hr/mL||Standard Deviation|Mean
802794|NCT00984009|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable colchicine concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic blood samples drawn immediately prior to colchicine dosing on Days 1 and 18, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after colchicine dose administration|||pg-hr/mL||Standard Deviation|Mean
802795|NCT00984009|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that colchicine reaches in the plasma.|serial pharmacokinetic blood samples drawn immediately prior to colchicine dosing on Days 1 and 18, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after colchicine dose administration|||pg/mL||Standard Deviation|Mean
802796|NCT00984022|Secondary|Number of Participants Who Experienced a 30% or Greater Reduction in Surface Area of Cellulitis.|Participants were assessed to see whether or not the surface area of the cellulitis was reduced by at least 30% and the number of such participants was reported.|2 weeks|||Participants|||Number
802797|NCT00984022|Secondary|Change in Patient Rating of Pain|Change in mean pain score based on patient self-report, using Wong-Baker FACES pain rating scale. Scale ranges from 0 to 5, where 5 means the worst pain possible and 0 means no pain at all.|Baseline and 2 weeks|||Scores on a scale||Standard Deviation|Mean
802798|NCT00984022|Primary|Number of Participants Who Experienced a 30% or Greater Reduction in Surface Area of Abscess|Participants were assessed to see whether or not the surface area of the abscess was reduced by at least 30%, and the number of such participants is reported.|2 weeks|||Participants|||Number
802799|NCT00984061|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the colchicine plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable colchicine plasma concentration to the elimination rate constant.|serial pharmacokinetic blood samples collected immediately prior to dosing on Days 1 and 29, then at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours after dose administration|||ng-hr/mL||Standard Deviation|Mean
805552|NCT01004393|Secondary|Bowel Movement Assessment (Frequency, Consistency and Difficulty) After Administration of Subcutaneous Methylnaltrexone||48 hours after the dose of subcutaneous methylnaltrexone|||percentage of participants||95% Confidence Interval|Number
802800|NCT00984061|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the colchicine plasma concentration versus time curve beginning from the first dose (time 0) to the last measurable colchicine concentration (time t), as calculated by the linear trapezoidal method.|serial pharmacokinetic blood samples collected immediately prior to dosing on Days 1 and 29, then at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours after dose administration|||ng-hr/mL||Standard Deviation|Mean
802801|NCT00984061|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that colchicine reaches in the plasma.|serial pharmacokinetic blood samples collected immediately prior to dosing on Days 1 and 29, then at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours after dose administration|||ng/mL||Standard Deviation|Mean
802802|NCT00984126|Secondary|Haemostatic Response to Turoctocog Alfa (None, Moderate, Good or Excellent) in Treatment of Bleeds.|Haemostatic response to turoctocog alfa (none, moderate, good or excellent) in treatment of bleeds using a four-point response scale: none, moderate, good or excellent. The evaluation was done by patient, caregiver and/or investigator based on experience as follows: 1. Excellent: Abrupt pain relief and/or unequivocal improvement in objective signs of bleeding within approximately 8 hours after a single infusion 2. Good: Definite pain relief and/or improvement in signs of bleeding within approximately 8 hours after an infusion, but possibly requiring more than 1 infusion for complete resolution. 3. Moderate: Probable or slight beneficial effect within approximately 8 hours after the first infusion; usually requiring more than 1 infusion. 4. None: No improvement, or worsening of symptoms. This endpoint is measured during the preventive and on-demand sub-trial (during 90 months).|After 90 months|Full Aanalysis Set. The endpoint was measured for preventive and on-demand regimen for comparison of the efficacy of turoctocog alfa between regimens. Number of subjects analysed=subjects who received preventive and on-demand regimen and were evaluable for this outcome.||Number of bleeds|||Number
802803|NCT00984126|Secondary|Annualised Bleeding Rate Reported During the Prevention Period (Only Applicable for Subjects in the Preventive Regimen)|The number of bleeding episodes per year reported during the prevention period (during 90 months).|After 90 months|Full Analysis Set. Number of subjects analysed=Subjects who received preventive regimen and were evaluable for the outcome.||Bleeding episodes/year||Full Range|Median
802804|NCT00984126|Secondary|Frequency of Adverse Events and Serious Adverse Events|The number of adverse events and serious adverse events reported during the main trial and the on-demand sub-trial (during 90 months).|After 90 months|Safety Analysis Set includes all dosed subjects with data after dosing.||Number of Events|||Number
802805|NCT00984126|Primary|Frequency of Development of FVIII Inhibitors (Greater Than or Equal to 0.6 Bethesda Units (BU)/mL)|The frequency of inhibitors was calculated as number of patients with inhibitors during the trial divided by number of patients in the trial. This endpoint was measured during the trial.|After 90 months|Full analysis set||subjects|||Number
802806|NCT00984139|Secondary|Number of Subjects With Anamnestic Response to the Challenge Dose as Measured by CLIA.|Anamnestic response was defined as: - At least (i.e. greater than or equal to) a 4-fold rise in post-challenge vaccine dose anti-HBs antibody concentrations in subjects seropositive (i.e. with anti-HBs antibody concentration ≥ 6.2 mIU/mL) at the pre-challenge dose time point. - Post-challenge dose anti-HBs antibody concentrations equal to or greater than 10 mIU/mL in subjects seronegative (i.e. with anti-HBs antibody concentrations < 6.2 mIU/mL) at the pre-challenge dose time point.|One month after the challenge dose (Month 1)|The analysis was performed on the according-to-protocol (ATP) cohort of immunogenicity on all evaluable subjects who had received a challenge dose of Engerix-B and for whom data concerning immunogenicity outcome measures were available at the time point after the Engerix-B challenge dose.||Subjects|||Number
802807|NCT00984139|Secondary|Number of Subjects With Anamnestic Response to the Challenge Dose as Measured by ELISA.|Anamnestic response was defined as: - At least (i.e. greater than or equal to) a 4-fold rise in post-challenge vaccine dose anti-HBs antibody concentrations in subjects seropositive (i.e. with anti-HBs antibody concentration equal to or greater than 3.3 mIU/mL) at the pre-challenge dose time point. - Post-challenge dose anti-HBs antibody concentrations equal to or greater than 10 mIU/mL in subjects seronegative (i.e. with anti-HBs antibody concentrations less than 3.3 mIU/mL) at the pre-challenge dose time point.|One month after the challenge dose (Month 1)|The analysis was performed on the according-to-protocol (ATP) cohort of immunogenicity on all evaluable subjects who had received a challenge dose of Engerix-B and for whom data concerning immunogenicity outcome measures were available at the time point after the Engerix-B challenge dose.||subjects|||Number
802808|NCT00984139|Primary|Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations as Measured by ChemiLuminescence ImmunoAssay (CLIA) Equal to or Above Cut-off Value.|The cut-off value was defined as 100 milli-international units per milliliter (mIU/mL).|One month after the challenge dose (Month 1)|The analysis was performed on the according-to-protocol (ATP) cohort of immunogenicity on all evaluable subjects who had received a challenge dose of Engerix-B and for whom data concerning immunogenicity outcome measures were available at the time point after the Engerix-B challenge dose.||Subjects|||Number
802809|NCT00984139|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31-day (Day 0-30) follow-up period following the challenge dose vaccination|The analysis was performed on the Total Vaccinated cohort.||subjects|||Number
802810|NCT00984139|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|After the challenge dose of the vaccine (Day 0) up to the study end (Month 1)|The analysis was performed on the Total Vaccinated cohort.||subjects|||Number
802811|NCT00984139|Secondary|Number of Subjects With Solicited Local and General Symptoms|"Solicited local symptoms were pain, redness and swelling. Solicited general symptoms were fatigue, gastrointestinal symptoms, headache and fever.
Fever was defined as axillary temperature greater than or equal to 37.5 degrees Celsius."|During the 4-day (Day 0-3) follow-up period following the challenge dose vaccination|The analysis was performed on the Total Vaccinated cohort.||subjects|||Number
806763|NCT01016834|Secondary|Treatment Preference|Number of subjects preferring Sumavel DosePro compared to their pre-study migraine treatment (Prefer Sumavel DosePro vs. No Preference or Prefer Other Treatment).|After 4 migraines or 60 days|||participants|||Number
802812|NCT00984139|Secondary|Number of Subjects With Anti-HBs Antibody Concentrations as Measured by CLIA Equal to or Above Cut-off Values|The cut-off values were defined as 6.2 mIU/mL, 10 mIU/mL and 100 mIU/mL. Note: the number of subjects with anti-HBs antibody concentrations equal to or above 100 mIU/mL on month post-challenge dose data are presented as a primary outcome measure.|Before (Day 0) and one month (Month 1) after the challenge dose|The analysis was performed on the according-to-protocol (ATP) cohort of immunogenicity on all evaluable subjects who had received a challenge dose of Engerix-B and for whom data concerning immunogenicity outcome measures were available at the time point after the Engerix-B challenge dose.||Subjects|||Number
802813|NCT00984139|Secondary|Number of Subjects With Anti-HBs Antibody Concentrations as Measured by ELISA Equal to or Above Cut-off Values|"The cut-off values were defined as 3.3 mIU/mL, 10 mIU/mL and 100 mIU/mL.
Note: the number of subjects with anti-HBs antibody concentrations equal to or above 100 mIU/mL on month post-challenge dose data are presented as a primary outcome measure."|Before (Day 0) and one month (Month 1) after the challenge dose|The analysis was performed on the according-to-protocol (ATP) cohort of immunogenicity on all evaluable subjects who had received a challenge dose of Engerix-B and for whom data concerning immunogenicity outcome measures were available at the time point after the Engerix-B challenge dose.||subjects|||Number
802814|NCT00984139|Primary|Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations as Measured by ELISA Equal to or Above Cut-off Value|The cut-off value was defined as 100 milli-international units per milliliter (mIU/mL).|One month after the challenge dose (Month 1)|The analysis was performed on the according-to-protocol (ATP) cohort of immunogenicity on all evaluable subjects who had received a challenge dose of Engerix-B and for whom data concerning immunogenicity outcome measures were available at the time point after the Engerix-B challenge dose.||subjects|||Number
802817|NCT00984204|Secondary|Secondary Efficacy- Freedom From Recurrence of Typical Atrial Flutter up to 3 Months Post Procedure||3 months|||participants|||Number
802818|NCT00984204|Primary|Primary Efficacy- Bidirectional Block in the Cavo-tricuspid Isthmus and Non-inducibility of Typical Atrial Flutter at Least 30 Minutes Following the Last RF Ablation With the Cool Path Duo Ablation Catheter System is Obtained.||30 mins|||participants|||Number
802819|NCT00984204|Primary|Primary Safety- Incidence of Intra Procedural Serious Cardiac Adverse Events Occuring Within 7 Days of Post-procedure, Regardless of Whether a Determination Can be Made Regarding Device Relatedness.||7 days|||participants|||Number
802820|NCT00984256|Secondary|Measured Concentrations of Plasma Atovaquone With Determinations of Area Under the Curve|Plasma concentrations were used to determine the pharmacokinetic curves with determinations of area under the curve (AUC).The smallest AUC Day 0-6.5 associated with protection from detectable parasitemia, and the highest AUC Day 0-6.5 observed in any cases of malaria (prophylactic failures) were to be reported.|7, 6, 5, and 1 day prior to challenge; on the day of the challenge; 1, 4, 5, 6, 7, 8, 10and 14 days after the challenge; and on the day parasitemia develops.,|Analysis was done on subjects who completed the study according to protocol||ng*day/ml||Standard Deviation|Mean
802821|NCT00984256|Secondary|Measured Concentrations of Plasma Atovaquone With Determinations of T1/2.|Plasma concentrations (ng/ml) were used to determine the elimination half life (t1/2) of atovaquone (days).|7, 6, 5, and 1 day prior to challenge; on the day of the challenge; 1, 4, 5, 6, 7, 8, 10and 14 days after the challenge; and on the day parasitemia develops.,|Population for analysis included According to Protocol Population.||Days||Standard Deviation|Mean
802822|NCT00984256|Primary|Prophylactic Efficacy of 3 Different Doses of Atovaquone/Proguanil (Malarone@) Given 1 Week Before Infectious Sporozoite Challenge Using the P. Falciparum Human Challenge Model.|Number of participants with prophylactic efficacy was determined by the absence of cases of malaria parasitemia, defined as microscopically detectable parasitemia by Giemsa-stained thick smears, in those receiving any dose of Malarone as compared to the control (no treatment) group|Days 6-20|"Analysis population was According to Protocol which included participants meeting all eligibility criteria, not meeting any elimination criteria, complying with defined protocol procedures and for whom data are available."||participants with negative parasitemia|||Number
802823|NCT00984282|Secondary|AUC(0-12h),ss (Area Under the Concentration Time Curve From Time 0 to 12 Hours at Steady State)|Sorafenib AUC(0-12h),ss (area under the concentration time curve from time 0 to 12 hours at steady state) was estimated from the steady state plasma concentration.|A single pharmacokinetic plasma sample was collected at steady state (after 14 days of uninterrupted, unmodified sorafenib dosing)|Pharmacokinetic (PK) analysis set=participants with PK data collected after 14 days of uninterrupted and unmodified dosing of sorafenib. If an interruption occurred within 14 days prior to the sample, no doses may be missed for 3 days prior to the sample, and no more than 3 doses could be missed 4 to 14 days prior to the sample collection date.||mg*h/L||Standard Deviation|Geometric Mean
802824|NCT00984282|Secondary|Maximum Percent Reduction in Target Lesion Size Based on Central Assessment|The magnitude of change from baseline in target lesion size in evaluable participants with scans was determined.|From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years|PPS||Percentage of participants|||Number
802836|NCT00984295|Primary|Antibody Response to Diphtheria at 6 Weeks Postvaccination - GMT|Postvaccination Observed Geometric Mean Titer of Antibody to Diphtheria. (Titers measured using Vero Cell Culture Assay.)|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.||IU/mL||95% Confidence Interval|Geometric Mean
802825|NCT00984282|Secondary|Duration of Response (DOR) Based on Central Assessment|Duration of response was defined as the time from the first documented objective response of PR or CR, whichever was noted earlier, to disease progression or death (if death occurred before progression was documented). CR = Disappearance of all clinical and radiological evidence of tumor (both target and no-target). PR = At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum.|From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years|FAS - responders only||Days||Full Range|Median
802826|NCT00984282|Secondary|Response Rate Based on Central Assessment|Response rate was defined as the proportion of subjects whose best response was CR or PR. Per RECIST, CR and PR was to be confirmed by another scan at least 4 weeks later. CR = Disappearance of all clinical and radiological evidence of tumor (both target and no-target). PR = At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum.|From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years|PPS||Percentage of participants||95% Confidence Interval|Number
802827|NCT00984282|Secondary|Disease Control Rate (DCR) Based on Central Assessment|Disease control rate was defined as the proportion of subjects whose best response was complete response (CR), partial response (PR), or stable disease (SD). Per Response Evaluation Criteria in Solid Tumors (RECIST) criteria, CR and PR were to be confirmed by another scan at least 4 weeks later; SD had to be documented at least 4 weeks after date of randomization. CR = Disappearance of all clinical and radiological evidence of tumor (both target and no-target). PR = At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum. SD = steady state of disease which is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years|Per protocol set (PPS). A participant was included in the PPS if he/she was randomized and was evaluable for tumor response based on imaging data, had exposure to study medication, and had no major protocol deviations.||Percentage of participants||95% Confidence Interval|Number
802828|NCT00984282|Secondary|Time to Progression (TTP) Based on Central Assessment Incl. Clinical Progression Due to Bone Irradiation|Time to progression was defined at the time (days) from randomization to progression (based on central assessment [radiological and clinical progression due to bone irradiation])|From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years|FAS||Days||95% Confidence Interval|Median
802829|NCT00984282|Secondary|Overall Survival (OS)|Overall survival was defined as the time (days) from date of randomization to date of death due to any cause. Subjects still alive at the time of analysis were censored at their date of last contact. Since the median value could not be estimated due to censored data, the percentage of participants who died is presented.|From randomization of the first subject until the database cut-off (14 Jul 2015), study duration approximately six years|Full Analysis Set (FAS)||Percentage of participants|||Number
802830|NCT00984282|Primary|Progression-free Survival (PFS) Based on Central Assessment Incl. Clinical Progression Due to Bone Irradiation|PFS=time from randomization to first observed disease progression (radiological according to central assessment or clinical due to bone irradiation, whichever is earlier), or death due to any cause, if death occurred before progression. Progression was assessed by RECIST criteria, version 1.0, modified for bone lesions. PFS for participants without disease progression or death at the time of analysis or unblinding were censored at the last date of tumor assessment before unblinding. Participants with no tumor evaluation after baseline were censored at Day 1. PD (Progression Disease)=At least a 20% increase in sum of longest diameters (LD) of measured lesions taking as reference the smallest sum LD on study since the treatment started or the appearance of 1 or more new lesions. New lesions also constituted PD. In exceptional circumstances, unequivocal progression of a nonmeasured lesion may have been accepted as evidence of disease progression in participants with measurable disease.|Final analysis to be performed when approximately 267 progression-free survival events (centrally assessed) had occurred, study duration approximately three years|Full Analysis Set (FAS). The primary population for efficacy analysis was the FAS. The FAS was identical to the intent-to-treat (ITT) population, which was defined as all randomized participants. Participants were analyzed as randomized.||Days||95% Confidence Interval|Median
802831|NCT00984295|Primary|Antibody Response to Tetanus at 6 Weeks Postvaccination – GMT|Postvaccination Observed Geometric Mean Titer of Antibody to Tetanus. (Titers of tetanus antitoxin were measured with an indirect, noncompetitive enzyme immunoassay (EIA).)|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.||IU/mL||95% Confidence Interval|Geometric Mean
802832|NCT00984295|Primary|Antibody Response to Haemophilus Influenzae Type B (Hib) at 6 Weeks Postvaccination - GMT|Postvaccination observed GMT of antibody to Hib. (Anti-polyribosylribitol phosphate (PRP) was measured by RIA using radiolabeled-PRP according to a standard Farr technique and with a standard provided by the U.S. FDA.)|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.||mIU/mL||95% Confidence Interval|Geometric Mean
802833|NCT00984295|Primary|Antibody Response to Hepatitis B at 6 Weeks Postvaccination - GMT|Postvaccination Observed Geometric Mean Titer of Antibody to Hepatitis B. (Titers measured using the Quantitative AUSAB™ radioimmunoassay (RIA).)|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.||mIU/mL||95% Confidence Interval|Geometric Mean
802834|NCT00984295|Primary|Antibody Response to Pertussis Filamentous Hemagglutinin (FHA) at 6 Weeks Postvaccination - GMT|Postvaccination Observed Geometric Mean Titer of Antibody to Pertussis Filamentous Hemagglutinin (FHA). (Titers measured using an indirect, noncompetitive Pertussis enzyme immunoassay (EIA).)|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.||units/mL||95% Confidence Interval|Geometric Mean
802835|NCT00984295|Primary|Antibody Response to Pertussis Toxin (PT) at 6 Weeks Postvaccination - GMT|Postvaccination Observed Geometric Mean Titer of Antibody to Pertussis Toxin (PT). Titers measured using an indirect, noncompetitive Pertussis enzyme immunoassay (EIA).|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.||units/mL||95% Confidence Interval|Geometric Mean
802837|NCT00984295|Primary|Antibody Response to Varicella at 6 Weeks Postvaccination for Participants Initially Seronegative to Varicella at Baseline - GMT|Postvaccination Observed Geometric Mean Titer of Antibody to Varicella. (Titers measured using VZV gpELISA.)|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.||gpELISA units/mL||95% Confidence Interval|Geometric Mean
802838|NCT00984295|Primary|Antibody Response to Rubella at 6 Weeks Postvaccination for Participants Initially Seronegative to Rubella at Baseline - GMT|Postvaccination Observed Geometric Mean Titer of Antibody to Rubella. (Titers measured using Rubella ELISA.)|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to rubella at baseline, and followed protocol procedures.||IU/mL||95% Confidence Interval|Geometric Mean
802839|NCT00984295|Primary|Antibody Response to Mumps at 6 Weeks Postvaccination for Participants Initially Seronegative to Mumps at Baseline - GMT|Postvaccination observed GMT of antibody to mumps. (Titers measured using mumps ELISA.)|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to mumps at baseline, and followed protocol procedures.||ELISA Ab units/mL||95% Confidence Interval|Geometric Mean
802840|NCT00984295|Primary|Antibody Response to Measles at 6 Weeks Postvaccination for Participants Initially Seronegative to Measles at Baseline - Geometric Mean Titer (GMT)|Postvaccination Observed Geometric Mean Titer of Antibody to Measles. (Titers measured using Measles ELISA.)|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to measles at baseline, and followed protocol procedures.||mIU/mL||95% Confidence Interval|Geometric Mean
802841|NCT00984295|Primary|Number of Participants With Postvaccination Haemophilus Influenzae Type B (Hib) Radioimmunoassay (RIA) Antibody Titer ≥ 1 mcg/mL|Antibody response to Haemophilus influenzae type B (Hib). (Anti-polyribosylribitol phosphate (PRP) was measured by radioimmunoassay (RIA) using radiolabeled-PRP according to a standard Farr technique and with a standard provided by the U.S. FDA.)|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.||Participants|||Number
802842|NCT00984295|Primary|Number of Participants With Postvaccination Hepatitis B (Quantitative AUSAB™ Radioimmunoassay (RIA)) Antibody Titer ≥10 mIU/mL|Antibody response to Hepatitis B (titers measured using the Quantitative AUSAB™ radioimmunoassay (RIA)).|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.||Participants|||Number
802843|NCT00984295|Primary|Number of Participants With ≥4-fold Rise in Pertussis Filamentous Hemagglutinin (FHA) EIA Antibody Titer|Antibody response to pertussis FHA(titers of pertussis filamentous hemagglutinin antibodies were measured with an indirect, noncompetitive EIA).|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.||Participants|||Number
802844|NCT00984295|Primary|Number of Participants With ≥4-fold Rise in Pertussis Toxin (PT) EIA Antibody Titer|Antibody response to Pertussis Toxin (titers of pertussis toxin antibodies were measured with an indirect, noncompetitive EIA).|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.||Participants|||Number
802845|NCT00984295|Primary|Number of Participants With Postvaccination Tetanus Enzyme Immunoassay (EIA) Antibody Titer ≥0.1 IU/mL|Antibody response to Tetanus (tetanus antitoxin were measured with an indirect, noncompetitive enzyme immunoassay (EIA)) at 6 weeks postvaccination.|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.||Participants|||Number
802846|NCT00984295|Primary|Number of Participants With Postvaccination Diphtheria Vero Cell Culture Assay Antibody Titer ≥0.1 IU/mL|Antibody response to Diphtheria at 6 weeks postvaccination|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.||Participants|||Number
802847|NCT00984295|Primary|Number of Participants With Postvaccination Varicella-Zoster Virus (VZV) Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Antibody Titer ≥5 gpELISA Units/mL|Antibody Response to Varicella-Zoster Virus (VZV) at 6 Weeks Postvaccination for Participants Initially Seronegative (a titer <0.6 gpELISA units/mL) to VZV at Baseline|6 weeks Postvaccination|"The per-protocol analysis set included participants
who had pre- and post-randomization blood samples within predefined day ranges, were seronegative to
varicella at baseline, and followed protocol procedures."||Participants|||Number
802848|NCT00984295|Primary|Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL|Antibody Response to Rubella at 6 Weeks Postvaccination for Participants Initially Seronegative (a titer <10 IU/mL) to Rubella at Baseline|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges, were seronegative to rubella at baseline, and followed protocol procedures.||Participants|||Number
802849|NCT00984295|Primary|Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥10 Ab Units/mL|Antibody Response to Mumps at 6 Weeks Postvaccination for Participants Initially Seronegative (a titer <10 Ab units/mL) to Mumps at Baseline|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges, were seronegative to mumps at baseline, and followed protocol procedures.||Participants|||Number
802850|NCT00984295|Primary|Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥120 mIU/mL|Antibody Response to Measles at 6 Weeks Postvaccination for Participants Initially Seronegative (a titer <120 mIU/mL) to Measles at Baseline|6 Weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges, were seronegative to measles at baseline, and followed protocol procedures.||Participants|||Number
802883|NCT00984620|Secondary|Rapid Virological Response at Week 4 (RVR)|Rapid virological response at week 4 (RVR): The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at week 4.|4 weeks|PPS||participants|||Number
802851|NCT00984308|Secondary|Sleep Apnea Treatment Rate||One year|Among the 58 intervention patients with a diagnosis of sleep apnea, CPAP data were available for 57. Among the 7 control patients who received polysomnography as part of usual care, 5 had sleep apnea: CPAP data were available for 4 patients (2 did not receive any CPAP and 2 had CPAP therapy), the data card was unavailable for 1 patient.||participants|||Number
802852|NCT00984308|Primary|Hypertension Control|Medication-Adjusted Systolic Blood Pressure|One year|ITT||mm Hg||Standard Deviation|Mean
802853|NCT00984308|Primary|Sleep Apnea Diagnosis Rate|The number of patients with a diagnosis of sleep apnea|The entire study period (baseline and up to one-year)|The intervention patients had polysomnography at baseline (n=102) whereas control patients either had polysomnography as part of usual care (n=7) or at the end of the study as part of the study protocol (n=85). The n=7 patients who had polysomnography as part of usual care were included in the analysis for this outcome.||participants|||Number
802854|NCT00984334|Primary|Incidence and Severity of Treatment Emergent Adverse Events on Single Dosing.|Incidence and severity of treatment emergent adverse events on single dosing.|3 weeks|Intent to treat.||participants|||Number
802855|NCT00984490|Secondary|Changes in Circulating Insulin-like Growth Factor 1 (IGF-1) and IGF Binding Protein 3 (IGFBP-3)|Effect of study drug on circulating IGF-1 and IGFBP-3 as measured in ng/mL in peripheral blood samples taken pre-treatment and post-treatment with metformin|baseline and 23 days|No levels of IGF-1 and IGFBP-3 were determined. This clinical trial was closed due to slow accrual.||units on a scale||Standard Deviation|Mean
802856|NCT00984490|Primary|Change in Ki67 Levels Before and After Treatment|Change in Ki67 levels in pre-treatment, pre-surgery and post-treatment, surgically excised breast tissue. Measured by percentage of positive-staining nuclei with a minimum of 0% to a maximum of 100%. A mean score is determined.|baseline and between 8-23 days|No Ki67 levels were determined. This clinical trial was closed due to slow accrual||percentage of stained cell nuclei||Standard Deviation|Mean
802857|NCT00984542|Secondary|Overall Survival|Estimated probable duration of life from on‐study date to date of death from any cause, using the Kaplan‐Meier method with censoring (see analysis population description for additional details)|On study to date of death from any cause or last date known alive, measured every 6-8 weeks from the end of treatment, up to 31 months|All patients are included in the analysis on intention‐to-treat basis. Analysis is by Kaplan‐Meier method, where death is an event, with censoring for non‐expired patients at greater of off‐study date or last known alive date.||days||95% Confidence Interval|Median
802858|NCT00984542|Secondary|Progression-free Survival|Estimated probable duration of life without disease progression, from on‐study date to earlier of progression date or date of death from any cause, using the Kaplan‐Meier method with censoring (see analysis population description for additional details). Disease progression is defined under RECIST v1.1 as >=20% increase in sum of longest diameters of target lesions, unequivocal progression of non‐target lesions, or appearance of new lesions.|On‐study date to lesser of date of progression or date of death from any cause ,measured following cycle 2, 4, 6 of a 21-day cycle for 6 cycles, (assessed up to 126 days)|All patients are included in the analysis on intention‐to-treat basis. Analysis is by Kaplan‐Meier method, where either death or progression is an event, with censoring for non‐progressed, non‐expired patients at greater of off‐study date or last known alive date.||days||95% Confidence Interval|Median
802859|NCT00984542|Secondary|Best Response|"Number of patients in each response category, per RECIST v1.1, summarized as follows for target lesion criteria (see RECIST v1.1 for additional details):
complete response (CR),disappearance of target lesions; partial response (PR), >=30% decrease in sum of longest diameter of target lesions; progressive disease (PD), >=20% increase in sum of LD of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or SD. Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR>PR>SD>PD."|On‐treatment date to date of disease progression, following cycle 2, 4, and 6 of a 21-day cycle for 6 cycles, (assessed up to 126 days)|All patients with best overall response data; patients are excluded if best overall response data is missing or if the patient is non-evaluable for best overall response. 8 patients were not evaluable.||participants|||Number
802860|NCT00984542|Secondary|Number of Patients With Each Worst-grade Toxicity|Number of patients with worst-grade toxicity at each of five grades following NCI Common Toxicity Criteria with grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life-threatening/disabling, 5 = death.|Day 1 of each 21-day cycle for 6 cycles and at 30 days after end of treatment, at 156 days|Total number of patients reported with any toxicity||participants|||Number
802861|NCT00984542|Primary|Time to Progression|Estimated probable duration from on-study date to date of disease progression, using the Kaplan‐Meier method with censoring (see analysis population description for additional details). Disease progression is defined under RECIST v1.1 as >=20% increase in sum of longest diameters of target lesions, unequivocal progression of non‐target lesions, or appearance of new lesions.|On-study to date of progression, measured following cycle 2, 4, and 6 of a 21-day cycle for 6 cycles, (during 126 days)|All patients are included in the analysis on intention-to treat basis. Analysis is by Kaplan‐Meier method, where progression is an event, with censoring for non-progressed patients at greater of off‐study date, last known alive date, or date of death not attributable to disease progression.||days||95% Confidence Interval|Median
802862|NCT00984568|Primary|Number of Participants With Response at Week 4 and Steroid-Free Remission at Week 50|Response at Week 4 was defined as a minimum decrease from baseline in Mayo score of 3 points and 30%. Steroid-free remission at Week 50 was defined as a total Mayo score (including endoscopic assessment) of 2 points or lower and no individual subscore exceeding 1. The Mayo score consists of the following 4 subscores: stool frequency; rectal bleeding; endoscopy results; physician’s global assessment. Each subscore is rated on a scale from 0 (best) to 3 (worst). The total Mayo score is calculated as the sum of the 4 subscores and ranges from 0 (best) to 12 (worst).|Week 50|The FAS consisted of all randomized participants who received at least one dose of study treatment.||Participants|||Number
802884|NCT00984620|Primary|Virological Response at Week 28 (W28VR)|Virological response at Week 28: The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at Week 28.|28 weeks|Per Protocol Set (PPS): included all patients in the FAS without important protocol deviations.||participants|||Number
812461|NCT01070784|Primary|Clinical Laboratory Test: Clinical Chemistry- S-Total Bilirubin|Change from baseline|Baseline and 52 week after|||mg/dL||Standard Deviation|Mean
802863|NCT00984568|Secondary|Number of Participants Achieving Treatment Response|"Response was defined as a minimum decrease from baseline in total Mayo score of 3 points and 30% up to and including 4 weeks after the start of treatment. The Mayo score consists of the following 4 subscores: stool frequency; rectal bleeding; endoscopy results; physician’s global assessment. Each subscore
is rated on a scale from 0 (best) to 3 (worst). The total Mayo score is calculated as the sum of the 4 subscores and ranges from 0 (best) to 12 (worst)."|Up to Week 4|The full analysis set (FAS) consisted of all randomized participants who received at least one dose of study treatment.||Participants|||Number
802864|NCT00984594|Secondary|Lysholm Score at 24 Months|The Lysholm scores from the 24-month exams are shown. The Lysholm score is an indexed score of knee functional ability, with 0 being the worst score and 100 being the best score, indicating no limitations in activity/function.|24 months|Of the 2 patients enrolled in the study in the backfill group, 1 was lost to follow-up, therefore the data presented is for only 1 patient.||units on a scale||Full Range|Mean
802865|NCT00984594|Secondary|Magnetic Resonance Imaging (MRI) Results|MRI images were graded by a radiologist with regard to the incorporation of the CR graft in both the cancellous and cortical portions of the bone at the graft site. The raw scores were converted to an index scale form 0 to 100, with 0 representing failure of the graft to incorporate and 100 representing complete incorporation of the graft.|24 months|Of the 2 patients enrolled in the study in the backfill group, 1 was lost to follow-up, therefore the data presented is for only 1 patient.||units on a scale||Full Range|Mean
802866|NCT00984594|Secondary|IKDC Assessment|The International Knee Documentation Committee (IKDC) scores from 24 months are shown. The IKDC is an index score from 0 to 100, with 100 being the best possible score,|24 months|Of the 2 patients enrolled in the study in the backfill group, 1 was lost to follow-up, therefore the data presented is for only 1 patient.||units on a scale||Full Range|Mean
802867|NCT00984594|Secondary|Current Health Assessment (CHA)|Evaluation on the Current Health Assessment at 24 months. Scores are transformed to a 0–100 scale, with zero representing a self-graded perception of extremely poor health and 100 representing no health problems. Scores between 0 and 100 represent the percentage of total possible score achieved.|24 months|Of the 2 patients enrolled in the study in the backfill group, 1 was lost to follow-up, therefore the data presented is for only 1 patient.||units on a scale||Full Range|Mean
802868|NCT00984594|Primary|Knee Injury and Osteoarthritis Outcome Score (KOOS|The outcome at 24 months as measured by the Knee injury and Osteoarthritis Outcome Score (KOOS). Scores are transformed to a 0–100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.|24 months|Of the 2 patients enrolled in the backfill group, 1 was lost to follow-up, therefore the data presented is for only 1 patient.||units on a scale||Full Range|Mean
802869|NCT00984620|Secondary|Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (6)|Change from baseline (CFB) in PT-INR (ratio).|baseline and 48 weeks|TS||ratio||Standard Deviation|Mean
802870|NCT00984620|Secondary|Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)|Change from baseline (CFB) in AST/GOT, ALT/GPT, Alka. phosphatase, GGT, Creatine kinase, Lipase, and Amylase.|baseline and 48 weeks|TS||U/L||Standard Deviation|Mean
802871|NCT00984620|Secondary|Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)|Change from baseline (CFB) in Sodium, Bicarbonate, Cholesterol total, Triglyceride, and Glucose.|baseline and 48 weeks|TS||mmol/L||Standard Deviation|Mean
802872|NCT00984620|Secondary|Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3)|Change from baseline (CFB) in Platelets and white blood cells.|baseline and 48 weeks|TS||10^9 cells/L||Standard Deviation|Mean
802873|NCT00984620|Secondary|Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2)|Change from baseline (CFB) in haematocrit and Eosinophils.|baseline and 48 weeks|TS||% of laboratory test substance||Standard Deviation|Mean
802874|NCT00984620|Secondary|Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (1)|Change from baseline (CFB) in Red blood cells.|baseline and 48 weeks|TS||10^12 cells/L||Standard Deviation|Mean
802875|NCT00984620|Secondary|Number of Participants With Clinically Relevant Abnormalities Vital Signs, and Physical Examination|No number of participants with clinically relevant abnormalities in vital signs and physical examination.|48 weeks|TS||participants with abnormality|||Number
802876|NCT00984620|Secondary|Laboratory Test Abnormalities and Study Medication Tolerabilities|Participants with possible clinically significant laboratory test abnormalities observed in functional groups: Haematology, Coagulation, Electrolytes, Enzymes, Substrates and Differentials, automatic.|48 weeks|Treated Set (TS): comprised all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment regardless of randomisation.||participants|||Number
802877|NCT00984620|Secondary|Time to Reach a Plasma HCV RNA Level BLD While on Treatment|Time to reach a plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) level below the lower limit of detection (BLD) while on treatment|48 weeks|PPS||week||Inter-Quartile Range|Median
802878|NCT00984620|Secondary|Viral Load (HCV RNA) at All Visits During Treatment and Follow-up|Viral load of Hepatitis C virus Ribonucleic acid (HCV RNA) at all visits during treatment (TRT) and follow-up, ie. change from baseline viral load at all visits.|From baseline to 72 weeks|PPS||IU/mL||Standard Deviation|Mean
802879|NCT00984620|Secondary|Sustained Virological Response (SVR24) at 24 Weeks After Completion of All Therapy|Sustained Virological Response (SVR24) at 24 weeks: The patients who reached plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at 24 weeks after completion of all Hepatitis C virus (HCV) therapy.|72 weeks|PPS||participants|||Number
802880|NCT00984620|Secondary|End of Treatment Response (ETR)|End of Treatment Response (ETR): The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at end of all therapy.|up to 48 weeks|PPS||participants|||Number
802881|NCT00984620|Secondary|Virological Response at Week 36 (W36VR)|Virological response at week 36 (W36VR): the patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at week 36.|36 weeks|PPS||participants|||Number
802882|NCT00984620|Secondary|Virological Response at Week 24 (W24VR)|virological response at week 24 (W24VR): The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at week 24.|24 weeks|PPS||participants|||Number
802919|NCT00985010|Primary|Clinical Evolution|Number of participants who died versus those who remained alive after 6 months of follow up since the first entrance at the Emergency Room|six months|We made a clinical follow up from nine encephalopathic patients. After six months we studied the differences in Mn, hemoglobin, etc., between those patients still alive and those who died.||participants|||Number
802920|NCT00985114|Primary|Percent (%) of Subjects Who Achieve a ≥ 0.5% Reduction in HbA1C at 24 Weeks or Last Visit From Baseline.||6 months|||% of participants|||Number
812462|NCT01070784|Primary|Clinical Laboratory Test: Clinical Chemistry- S-Creatinine|Change from baseline|Baseline and 52 week after|||mg/dL||Standard Deviation|Mean
802905|NCT00984698|Primary|Depression|Hamilton Rating Scale for Depression, 17 item The Hamilton Rating Scale for Depression is an interview assessment of depression symptom severity. Total score range is from 0 (no symptoms of depression) to 52 (maximum symptoms of depression).|post-treatment, at 12 weeks|"CBSRT arm: 18 participants completed 75% of psychotherapy sessions; 20 participants completed study assessment at 12-week post-treatment time point
PCGT arm: 14 participants completed 75% of psychotherapy sessions; 17 participants completed study assessment at 12-week post-treatment time point"||units on a scale||Standard Deviation|Mean
802906|NCT00984698|Secondary|PTSD|Clinician-Administered PTSD Scale (CAPS), DSM-IV The CAPS is a 17-item interview assessment post-traumatic stress disorder (PTSD) symptom severity. Total score ranges from 0 (no PTSD symptoms) to 136 (maximum PTSD symptoms).|post-treatment, at 12 weeks|"CBSRT arm: 18 participants who completed 75% of psychotherapy sessions; 20 participants who completed 12-week post-treatment assessment
PCGT arm: 14 participants who completed 75% of psychotherapy sessions; 17 participants who completed 12-week post-treatment assessment"||units on a scale||Standard Deviation|Mean
802907|NCT00984815|Secondary|Change From Baseline in the Satisfaction With Dyspepsia-Related Health Scale of the Severity of Dyspepsia Assessment (SODA) Questionnaire at 54 Weeks|The satisfaction with dyspepsia-related health scale of the SODA questionnaire ranges from 2 - 23. Change from baseline compares the score at Week 54 to the baseline score for each participant who completed the Satisfaction questions of the SODA questionnaire at baseline and Week 54. A positive change from baseline in the SODA satisfaction scale represents a participant's overall improved satisfaction with their dyspepsia-related health.|Baseline and 54 Weeks|55 participants who completed the satisfaction with dyspepsia-related health questions of the SODA questionnaire at baseline and week 54.||Scores on a scale||Standard Deviation|Mean
802908|NCT00984815|Secondary|Change From Baseline in the Non-pain Symptoms Scale of the Severity of Dyspepsia Assessment (SODA) Questionnaire at 54 Weeks|The non-pain symptom scale of the SODA questionnaire ranges from 7 - 35. Change from baseline compares the score at Week 54 to the baseline score for each participant that completed the non-pain symptom questions of the SODA questionnaire at baseline and Week 54. Higher scores indicate greater symptom severity and therefore a negative mean change from baseline is indicative of an improvement in symptoms.|Baseline and 54 Weeks|55 participants who completed the non-pain symptom questions of the SODA questionnaire at baseline and Week 54.||Scores on a scale||Standard Deviation|Mean
802909|NCT00984815|Primary|Number of Participants With Treatment Emergent Adverse Events||54 weeks|All participants enrolled and who received at least one dose of study drug comprised the Safety Population.||participants|||Number
802910|NCT00984815|Secondary|Change From Baseline in the Pain Intensity Scale of the Severity of Dyspepsia Assessment (SODA) Questionnaire at 54 Weeks|The pain intensity scale of the SODA questionnaire ranges from 2 - 47. Change from baseline compares the score at Week 54 to the baseline score for each participant who completed the pain intensity questions of the SODA questionnaire at baseline and Week 54. Higher scores indicate greater symptom severity and therefore a negative mean change from baseline is indicative of an improvement in symptoms.|Baseline and 54 Weeks|54 participants who completed the pain intensity questions of the SODA questionnaire at baseline and Week 54.||Scores on a scale||Standard Deviation|Mean
802911|NCT00984867|Secondary|Proportion of Participants Achieving a Therapeutic Glycemic Response Defined as a Reduction in HbA1c of ≥0.7% Compared to Baseline|To compare the proportion of participants achieving a therapeutic glycaemic response, defined as a reduction in HbA1c of ≥0.7% compared to baseline, with dapagliflozin versus placebo at week 24. Least Squares Mean represents the percent of participants adjusted for HbA1c baseline value.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values||Percentage of participants||95% Confidence Interval|Least Squares Mean
802912|NCT00984867|Secondary|Adjusted Mean Change in 2-hour Post Liquid Meal Glucose Rise|To compare the change in 2-hour post liquid meal glucose rise achieved with dapagliflozin versus placebo from baseline to week 24.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values||mg/dL||95% Confidence Interval|Least Squares Mean
802913|NCT00984867|Secondary|Adjusted Mean Change in Seated Systolic Blood Pressure (SBP) in Participants With Baseline SBP>=130 mmHg|To compare the change in seated systolic blood pressure (SBP) in participants with baseline seated SBP >=130 achieved with dapagliflozin versus placebo from baseline to week 8.|Baseline to Week 8|Full analysis set, participants with baseline SBP>=130mmHg and Week 8 (LOCF) value||mmHg||95% Confidence Interval|Least Squares Mean
802914|NCT00984867|Secondary|Adjusted Mean Change in Fasting Plasma Glucose (FPG)|To compare the change in FPG achieved with dapagliflozin versus placebo from baseline to week 24.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values||mg/dL||95% Confidence Interval|Least Squares Mean
802915|NCT00984867|Secondary|Adjusted Mean Change in HbA1c in Participants With Baseline HbA1c ≥8%|To compare the change in HbA1c in participants with baseline HbA1c ≥8% achieved with dapagliflozin versus placebo from baseline to week 24.|Baseline to Week 24|Full analysis set, participants with baseline HbA1c >=8% and Week 24 (LOCF) value||Percent||95% Confidence Interval|Least Squares Mean
802916|NCT00984867|Secondary|Adjusted Mean Change in Body Weight|To compare the change in total body weight achieved with dapagliflozin versus placebo from baseline to week 24.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values||kg||95% Confidence Interval|Least Squares Mean
802917|NCT00984867|Primary|Adjusted Mean Change in HbA1c Levels|To compare the change from baseline in HbA1c after 24 weeks treatment (LOCF) between dapagliflozin and placebo in patients with type 2 diabetes who are inadequately controlled on sitagliptin alone or on sitagliptin plus metformin.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values||Percent||95% Confidence Interval|Least Squares Mean
802918|NCT00985010|Secondary|Manganese Levels|From encephalopathic patients, we took individual blood samples, analyzed in the biochemistry laboratory at the National Institute of Neurology and Neurosurgery, Mexico, City, with a graphite furnace atomic absorption spectrometer, according to the technique reported by Pleban.|Up to six months we followed the recruited patients to determine who were still alive|All patients attended at the Internal Medicine Service with Hepatic Encephalopathy were included. The analysis was per protocol.||μg/L||Standard Deviation|Mean
805553|NCT01004393|Secondary|Symptoms of Opioid Withdrawal (Modified Himmelsbach Withdrawal Scales (Ranging 7-28 in Total; 1=None - 4=Severe for 7 Items)) After Administration of Subcutaneous Methylnaltrexone||48 hours after the dose of subcutaneous methylnaltrexone|||units on a scale||Standard Deviation|Mean
802921|NCT00985140|Primary|Clinical Response Rate|"After the completion of TSEBT, patients will be followed every 4 weeks until 24 weeks ,and then every 8 weeks for a total of 12 months or until there is disease progression, relapse, or the initiation of a new anti-cancer therapy.
The primary endpoint for the trial was the clinical response rate as defined by the modified severity weighted assessment tool (mSWAT) Partial response was defined as 50% improvement in the mSWAT. Complete response was complete disappearance of disease."|1 year|All patients who completed treatment.||participants|||Number
802922|NCT00985153|Primary|Number of Participants With Serious Vaccine-related CAEs|Subjects with a serious vaccine-related CAE (an AE which is assessed by an investigator/qualified physician as being related to study vaccine and results in death, persistent or significant disability/incapacity, prolongs an existing inpatient hospitalization, is life-threatening, a congenital anomaly/birth defect, a cancer, or an overdose).|6 weeks Postvaccination|All subjects with follow-up for safety were included in the analysis.||Participants|||Number
802923|NCT00985153|Primary|Antibody Response to Rubella for Subjects Initially Seronegative (a Titer < 10 IU/mL) to Rubella at Baseline – Geometric Mean Titer|Postvaccination observed Geometric Mean Titer of antibody to Rubella|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to rubella at baseline, and followed protocol procedures.||ELISA AB units||95% Confidence Interval|Mean
802924|NCT00985153|Primary|Antibody Response to Mumps for Subjects Initially Seronegative (a Titer < 10 Ab Units/mL) to Mumps at Baseline – Geometric Mean Titer|Postvaccination observed Geometric Mean Titer of antibody to Mumps.|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to mumps at baseline, and followed protocol procedures.||ELISA AB units||95% Confidence Interval|Mean
802925|NCT00985153|Primary|Antibody Response to Measles for Subjects Initially Seronegative (a Titer < 120 mIU/mL) to Measles at Baseline – Geometric Mean Titer|Postvaccination observed Geometric Mean Titer of antibody to Measles.|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to measles at baseline, and followed protocol procedures.||mIU/mL||95% Confidence Interval|Mean
802926|NCT00985153|Primary|Antibody Response to Varicella for Subjects Initially With Varicella Antibody Titer < 1.25 gpELISA Units/mL at Baseline - Geometric Mean Titer|Postvaccination observed Geometric Mean Titer of antibody to Varicella|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, Varicella Antibody Titer < 1.25 gpELISA units/mL at baseline, and followed protocol procedures.||gpELISA||95% Confidence Interval|Mean
802927|NCT00985153|Primary|Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥ 10 IU/mL|Antibody Response to Rubella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer < 10 IU/mL) to Rubella at Baseline|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to rubella at baseline, and followed protocol procedures.||Participants|||Number
802928|NCT00985153|Primary|Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥ 10 Ab Units/mL|Antibody Response to Mumps at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer < 10 Ab units/mL) to Mumps at Baseline|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to mumps at baseline, and followed protocol procedures.||Participants|||Number
802929|NCT00985153|Primary|Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥ 120 mIU/mL|Antibody Response to Measles at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer < 120 mIU/mL) to Measles at Baseline|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to measles at baseline, and followed protocol procedures.||Participants|||Number
802930|NCT00985153|Primary|Number of Participants With Postvaccination Varicella Antibody Titer ≥ 5 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL|Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially With Varicella Antibody Titer < 1.25 gpELISA units/mL at Baseline|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, Varicella Antibody Titer <1.25 gpELISA units/mL at baseline, and followed protocol procedures.||Participants|||Number
802931|NCT00985166|Primary|Antibody Response to Rubella for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer|Postvaccination observed Geometric Mean Titer of antibody to Rubella|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, received M-M-R™ II + VARIVAX™ prior to entering the study, and followed protocol procedures.||IU/mL||95% Confidence Interval|Geometric Mean
802932|NCT00985166|Primary|Antibody Response to Mumps for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer|Postvaccination observed Geometric Mean Titer of antibody to Mumps|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, received M-M-R™ II + VARIVAX™ prior to entering the study, and followed protocol procedures.||ELISA AB units/mL||95% Confidence Interval|Geometric Mean
802933|NCT00985166|Primary|Antibody Response to Measles for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer|Postvaccination observed Geometric Mean Titer of antibody to Measles|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, received M-M-R™ II + VARIVAX™ prior to entering the study, and followed protocol procedures.||mIU/mL||95% Confidence Interval|Geometric Mean
802934|NCT00985166|Primary|Antibody Response to Varicella for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer|Postvaccination observed Geometric Mean Titer of antibody to Varicella|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, received M-M-R™ II + VARIVAX™ prior to entering the study, and followed protocol procedures.||gpELISA units/mL||95% Confidence Interval|Geometric Mean
805554|NCT01004393|Secondary|Overall Pain Scores (0-10; 0=no Pain, 10=Worst Pain) After Administration of Subcutaneous Methylnaltrexone||48 hours after the dose of subcutaneous methylnaltrexone|||units on a scale||Standard Deviation|Mean
802935|NCT00985192|Secondary|Biomarker Correlations: Time to Progression|Potential correlations between time to progression and S6 protein and mTOR-related proteins in tumor tissue samples from these patients.|30 months|"Exploratory analysis of translational endpoints in patient samples, Representative paraffin blocks were required for all participating patients. Tissue blocks were obtained on 39 patients.
p-s6 and p-mTOR IHC expression in tumors"||months||95% Confidence Interval|Median
802936|NCT00985192|Secondary|Biomarker Correlations: Progression Free Survival|Potential correlations between progression free survival and S6 protein and mTOR-related proteins in tumor tissue samples from these patients.|30 months|"Exploratory analysis of translational endpoints in patient samples, Representative paraffin blocks were required for all participating patients. Tissue blocks were obtained on 39 patients.
p-s6 and p-mTOR IHC expression in tumors"||months||95% Confidence Interval|Median
802937|NCT00985192|Secondary|Observed Biomarkers|Potential correlations between clinical outcome and biomarkers of interest, including S6 protein overexpression and/or other mTOR-related proteins in tumor tissue samples from these patients.|30 months|"Exploratory analysis of translational endpoints in patient samples, Representative paraffin blocks were required for all participating patients. Tissue blocks were obtained on 39 patients.
p-s6 and p-mTOR IHC expression in tumors"||number of tissue blocks|||Number
802938|NCT00985192|Secondary|Efficacy in Terms of Progression Free Response|Progression-free survival (PFS), was defined as the time from the date of initial treatment to first objective documentation of disease progression, or death. Estimated using the Kaplan–Meier method. Complete response (CR) + partial response (PR) + stable disease (SD) were determined according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Radiologic disease assessments were utilized.|evry 3 months in year 1, every 6 months after that|||months||95% Confidence Interval|Median
802939|NCT00985192|Secondary|Overall Survival|Overall Survival (OS), defined as the time from date of initial treatment to date of death. Survival function was estimated using the Kaplan–Meier method.|2.5 year|||months||95% Confidence Interval|Median
802940|NCT00985192|Primary|Overall Disease-control Rate in Patients With Previously Treated Unresectable or Metastatic Adenocarcinoma of the Upper Gastrointestinal Tract Treated With Everolimus.|Disease control rate (DCR), defined as complete response (CR) + partial response (PR) + stable disease (SD) according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria.|Radiologic disease assessment was performed every 8 weeks (14 days = 1 cycle) treatment discontinuation.|||percent subjects with disease control||95% Confidence Interval|Number
802941|NCT00985231|Secondary|Subjective Ratings of Eye Strain|Convergence Insufficiency Symptom Survey (CISS), was used to assess eye strain symptoms measured on a scale of 1-4. 0 score=never, 4 score=always|2 week visit|All Eligible, Dispensed Eyes, CISS Composite Score||CISS Composite Score||Standard Deviation|Mean
802942|NCT00985231|Primary|Distance Visual Acuity (VA) Between Test and Control Lenses Worse Than 20/40.|Eyes with distance lens VA of 20/40 or worse at study exit between test and control lenses.|2 weeks|All Eligible, Dispensed Eyes with non-missing scores||eyes|Participants||Number
802943|NCT00985257|Primary|Percent of Blood Glucose (BG) Results Within +/-15mg/dL or +/-20% of Laboratory Glucose Method|Subjects with diabetes and healthcare professionals (HCPs) used a new blood glucose monitoring system (BGMS) with subject blood. BGM results were compared to a lab glucose method - Yellow Springs Instrument (YSI) Analyzer. Duplicate BG results were used to calculate the number of BG results within +/-15mg/dL (for reference BG results <75mg/dL) or +/- 20% (for reference BG values >/=75mg/dL) of the reference method results.|1-2 hours|To achieve glucose concentrations across the meter test range, 47 blood samples were modified. The total glucose distribution (total 121 natural capillary samples plus 47 modified) ranged from 25.7 to 563.5mg/dL. Two sets of subject results were not analyzed because sufficient sample was not obtained for the YSI reference test.||percent of blood glucose results|Participants||Number
802944|NCT00985439|Primary|Total Patient Pain Relief Over 0 to 12 Hours.|"Total patient pain relief was assessed as a time-weighted sum of the patient pain assessments at each individual time point from 0-12 hours.
Values for TOTPAR are measured from 0 to 4 on the Pain Relief Scale 0 None Min; 1 A little; 2 Some; 3 A lot; 4 Complete Max
The TOTPAR is a weighted measure of the observations; the minimum possible value is 0 and the maximum possible value is 60."|12 hours.|||units on a scale||95% Confidence Interval|Least Squares Mean
802945|NCT00985491|Secondary|Improvement in Type 2 Diabetic Status|Subjects who achieved HbA1c reduction of 0.5%|12 months|7 subjects were enrolled that had Type 2 Diabetes; endpoint evaluated subjects who achieved HbA1c reduction of 0.5%||% of subjects with T2DM|||Number
802946|NCT00985491|Primary|Assessment of % Excess Weight Loss|Primary efficacy was assessment of the percent excess weight loss (%EWL) at Week 52 or last assessment. Excess weight was determined from ideal body weights based on a body mass index (BMI) of 25 kg/m2. Percent excess weight loss from baseline to 12 months was calculated as [(baseline weight minus the 12-month weight) / (baseline weight minus the ideal body weight)] * 100).|12 months|||%EWL||Standard Error|Mean
802947|NCT00985504|Secondary|Percentage of Participants Who Discontinue Due to Lack of Efficacy During 8 Weeks|Percentage of participants who discontinue after baseline due to lack of efficacy in the investigator's opinion.|Baseline through 8 weeks|All randomized participants.||percentage of participants|||Number
802948|NCT00985504|Secondary|Number of Days From Baseline to Relapse as Defined by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score ≥16 During 8 Weeks|The number of days from baseline to the first relapse is defined as reaching a MADRS Total Score≥16. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Censored participants were included in the Kaplan-Meier analysis, the minimum and maximum time to relapse have been calculated and reported here. Median time to relapse and quartiles could not be computationally calculated using the Kaplan-Meier procedure due to low event rate and high completion rate (censored).|Baseline through 8 weeks|Number of participants in each treatment group having time to relapse plus the participants censored. Duloxetine had 200 participants censored and escitalopram had 199 participants censored.||days|||Number
802959|NCT00988429|Primary|Seizure Frequency Over the 12-week Maintenance Period.||12-week maintenance period (Week 3 to week 14)|Intent-to-treat (ITT) population was the primary population for the analysis of efficacy; ITT included all randomized subjects who received at least one dose of study treatment after randomization and had at least one post-baseline seizure frequency assessment.||Nº Standardized Seizures by 4 weeks||Standard Error|Least Squares Mean
802949|NCT00985504|Secondary|Percentage of Participants Who Relapsed During 8 Weeks|Relapse is defined as achieving a Montgomery-Asberg Depression Rating Scale (MADRS) total score≥16 at any time after baseline. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline through 8 weeks|All randomized participants with a baseline and at least 1 post-baseline result.||percentage of participants|||Number
802950|NCT00985504|Secondary|Change From Baseline in the Sheehan Disability Scale (SDS) Total and Individual Scores at Week 8|The SDS is a participant-rated assessment. Total scores range from 0-30 with higher values indicating greater disruption in the participant's work/social/family life. Items 1-3 assess the effect of the participant's symptoms on work/school schedule, social life/leisure activities, and family life/home responsibilities, respectively. Item scores are 0-10; higher values indicate greater disruption. Number of unproductive days and days lost in past week (symptom related) were reported. LS Mean Value was calculated from an ANCOVA model with terms of treatment, pooled investigator, and baseline.|Baseline, 8 weeks|All randomized participants with a baseline and at least 1 post-baseline result.||units on a scale||Standard Error|Least Squares Mean
802951|NCT00985504|Secondary|Change From Baseline in the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH-CPFQ) Total and Item Scores at Week 8|"The MGH-CPFQ is a 7-item participant-rated questionnaire evaluating the participant's cognitive and physical well-being during the past month. The MGH-CPFQ assesses motivation, wakefulness, energy, focus, recall, word-finding difficulty, and mental acuity. Each item is scored on a 6-point scale ranging from 1 (greater than normal) to 2 (normal) to 6 (totally absent). Total scores range from 7 to 42. Higher scores indicate greater disease severity. The LS Mean Value was calculated from an analysis of covariance (ANCOVA) model with terms of treatment, pooled investigator, and baseline."|Baseline, 8 weeks|All randomized participants with a baseline and at least 1 post-baseline result.||units on a scale||Standard Error|Least Squares Mean
802952|NCT00985504|Secondary|Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score and Item 8 (Inability to Feel) at Week 8|MADRS is a rating scale for severity of depressive mood symptoms and has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Item 8 assesses the participant's inability to feel. Scores range from 0 (normal interest in surroundings and other people) to 6 (emotional paralysis, inability to feel anger/grief/pleasure). The LS Mean Value was calculated from an MMRM model with terms of treatment, pooled investigator, visit, treatment*visit, baseline, and baseline*visit.|Baseline, 8 weeks|All randomized participants with a baseline and at least 1 post-baseline result.||units on a scale||Standard Error|Least Squares Mean
802953|NCT00985504|Secondary|Change From Baseline in the Clinical Global Impression of Severity (CGI-S) Rating Scale at Week 8|The CGI-S measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The LS Mean Value was calculated from an MMRM model with terms of treatment, pooled investigator, visit, treatment*visit, baseline, and baseline*visit.|Baseline, 8 weeks|All randomized participants with a baseline and at least 1 post-baseline result.||units on a scale||Standard Error|Least Squares Mean
802954|NCT00985504|Secondary|Patient’s Global Impressions of Improvement Scale (PGI-I) Rating Scale Score at Week 8|The PGI-I is a scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). The LS Mean Value was calculated from an MMRM model with terms of treatment, pooled investigator, visit, and treatment*visit.|8 weeks|All randomized participants.||units on a scale||Standard Error|Least Squares Mean
802955|NCT00985504|Secondary|Change From Baseline in the Rothschild Scale for Antidepressant Tachyphylaxis (RSAT) Total and Individual Item Scores at Week 8|RSAT assesses symptoms of apathy or decreased motivation among depressed participants who have achieved symptomatic remission with antidepressant treatment and consists of 6 self-report items assessing energy level, motivation and interest, cognitive functioning, weight gain, sleep and sexual functioning, as well as affect. Each item score ranges from 0 to 4 with total scores ranging from 0 to 28. Higher scores indicate greater disease severity. LS Mean Value was calculated from an MMRM model with terms of treatment, pooled investigator, visit, treatment*visit, baseline, and baseline*visit.|Baseline, 8 weeks|All randomized participants with a baseline at and least 1 post-baseline result.||units on a scale||Standard Error|Least Squares Mean
802956|NCT00985504|Secondary|Change From Baseline in the Apathy Evaluation Scale-Clinician Rated Version (AES-C) Subscale Scores at Week 8|AES-C subscales separately assess participants' intensity of cognitive, behavioral, emotional, and other apathy symptoms with individual item scores of 1 (not at all characteristic) to 4 (a lot characteristic). Subtotal score ranges for the subscales are: 8-32 (cognitive), 5-20 (behavioral), 2-8 (emotional), and 3-12 for other (display of personal insight, initiative and motivation). Higher subscale scores indicate greater illness severity. The LS Mean Value was calculated from an MMRM model with terms of treatment, pooled investigator, visit, treatment*visit, baseline, and baseline*visit.|Baseline, 8 weeks|All randomized participants with a baseline and at least 1 post-baseline result.||units on a scale||Standard Error|Least Squares Mean
802957|NCT00985504|Primary|Change From Baseline in the Apathy Evaluation Scale - Clinician Rated Version (AES-C) Total Score at Week 8|The AES-C is a validated 18-item instrument used to assess cognitive, behavioral, emotional and other symptoms of apathy. Clinicians rate each item based on verbal and nonverbal information provided by the participant. Item scores range from 1 (not at all characteristic) to 4 (a lot characteristic). Total scores range from 18 to 72 where higher derived scores indicate more severe apathy. The Least Squares (LS) Mean Value was calculated from a mixed model repeated measures (MMRM) model with terms of treatment, pooled investigator, visit, treatment*visit, baseline, and baseline*visit.|Baseline, 8 weeks|All randomized participants with a baseline and at least 1 post-baseline result.||units on a scale||Standard Error|Least Squares Mean
802958|NCT00988429|Secondary|Proportion of Responders|Subjects who had at least a 50% reduction from baseline in standardized seizure frequency during the maintenance period were classified as responders.|Baseline (Week-8 through Week -1) and Maintenance period (Week 3 to week 14)|Intent-to-treat (ITT) population was the primary population for the analysis of efficacy; ITT included all randomized subjects who received at least one dose of study treatment after randomization and had at least one post-baseline seizure frequency assessment.||percentage of participants||95% Confidence Interval|Number
802965|NCT00988442|Secondary|Antiretroviral (ARV) Medication Adherence at Week 24 Using Visual Analog Scale|ARV medication adherence at Week 24, as measured by the visual analog scale. The visual analog scale is a 0-100% scale that measures the percentage of HIV medication taken in the past month.|Week 24|Due to early study closure, only 40 participants had adherence data available at week 24 for this outcome.||percentage of HIV meds taken last month||Inter-Quartile Range|Median
802966|NCT00988442|Secondary|Antiretroviral (ARV) Medication Adherence at Week 12 Using Visual Analog Scale|ARV medication adherence at week 12, as measured by the visual analog scale. The visual analog scale is a 0-100% scale that measures the percentage of HIV medication taken in the past month.|Week 12|Due to early study closure, only 44 participants had adherence data available at week 12 for this outcome.||percentage of HIV meds taken last month||Inter-Quartile Range|Median
802967|NCT00988442|Secondary|Antiretroviral (ARV) Medication Adherence at Week 24 Using Four Day Recall|"ARV medication adherence, as measured by four day recall, i.e. Missed doses in last 4 days."|Week 24|Due to early study closure, only 39 participants had adherence data at week 24.||Participants|||Count of Participants
802968|NCT00988442|Secondary|Antiretroviral (ARV) Medication Adherence at Week 12 Using Four Day Recall|"ARV medication adherence at week 12, as measured by four day recall, i.e. Missed doses in last 4 days."|Week 12|Due to early study closure, only 42 participants had adherence data at week 12 for this outcome.||Participants|||Count of Participants
802969|NCT00988442|Secondary|Antiretroviral (ARV) Medication Adherence at Week 24 Using ACTG Adherence Questionnaire|ARV medication adherence at week 24, as measured by the ACTG adherence questionnaire index. The ACTG adherence questionnaire index is on a 0-100 scale where higher scores indicate better adherence.|Week 24|Due to early study closure, 31 participants had complete adherence data for this outcome.||units on a scale||Inter-Quartile Range|Median
802970|NCT00988442|Secondary|Antiretroviral (ARV) Medication Adherence at Week 12 Using ACTG Adherence Questionnaire|ARV medication adherence at week 12, as measured by the ACTG adherence questionnaire index. This questionnaire index is on a 0-100 scale, with higher scores indicating higher adherence.|Week 12|Due to early study closure, only 30 participants had complete adherence data for this outcome.||units on a scale||Inter-Quartile Range|Median
802971|NCT00988442|Secondary|Number of Participants With Virologic Suppression, Defined as HIV-1 RNA Less Than 1,000 Copies/mL at Week 48|Number of participants with virologic suppression, defined as HIV-1 RNA less than 1,000 copies/mL, at week 48.|Measured at Week 48|Due to early study closure, only the 14 participants that reached week 48 with available data were included in this analysis.||Participants|||Count of Participants
802972|NCT00988442|Secondary|Number of Participants With Virologic Suppression, Defined as HIV-1 RNA Less Than 1,000 Copies/mL at Week 24|Number of participants with virologic suppression, defined as HIV-1 RNA less than 1,000 copies/mL, at week 24.|Week 24|Due to early study closure, only the 41 participants who reached week 24 with available data were included in this analysis.||Participants|||Count of Participants
802973|NCT00988442|Secondary|Number of Participants With Virologic Suppression, Defined as HIV-1 RNA Less Than 1,000 Copies/mL at Week 12|Number of participants with virologic suppression, defined as HIV-1 RNA less than 1,000 copies/mL, at week 12.|Week 12|Due to early study closure, only the 43 participants who reached week 12 with available data were included in this analysis.||Participants|||Count of Participants
802974|NCT00988442|Secondary|Number of Participants With Virologic Suppression, Defined as HIV-1 RNA Less Than 200 Copies/mL at Week 24.|Number of participants with virologic suppression, defined as HIV-1 RNA less than 200 copies/mL, at week 24.|Week 24|Due to early study closure, only the 41 participants who reached week 24 with available data were included in this analysis.||Participants|||Count of Participants
802975|NCT00988442|Secondary|Number of Participants With Virologic Suppression, Defined as HIV-1 RNA Less Than 200 Copies/mL at Week 12|Number of participants with virologic suppression, defined as HIV-1 RNA less than 200 copies/mL, at week 12.|Week 12|Due to early study closure, only the 43 participants who reached week 12 with available virologic data were included in this analysis.||Participants|||Count of Participants
802976|NCT00988442|Secondary|Intervention Dosage Score for Enhanced Nursing Telephone Support (Total Amount of Time Spent in Calls)|Intervention dosage score for enhanced nursing telephone support. This is the total amount of time spent in calls overall.|Week 12|Only participants in the telephone support group were analyzed.||minutes||Inter-Quartile Range|Median
802977|NCT00988442|Secondary|Intervention Dosage Score for Enhanced Nursing Telephone Support (Total Percentage of Scheduled Calls Successfully Delivered)|Intervention dosage score for enhanced nursing telephone support. This is the total percentage of scheduled calls successfully delivered.|Measured at Week 12|Only participants in the telephone support group were analyzed.||percent of scheduled calls delivered||Standard Deviation|Mean
802978|NCT00988442|Secondary|Number of Participants Who Received Last Telephone Call if Prior to the End of Defined Intervention Period|Number of participants whose last telephone call received occurred prior to the end of the defined intervention period.|Measured from entry to Week 72 or premature study discontinuation|Only participants in the telephone support group were analyzed.||participants|||Number
802979|NCT00988442|Secondary|Number of Participants With Virological Suppression|Number of participants with virological suppression, defined as HIV-1 RNA less than 200 copies/mL.|Measured from entry to Week 72 or premature study discontinuation|All participants with scheduled post baseline HIV-1 RNA measurements.||participants|||Number
802980|NCT00988442|Secondary|Number of Participants With Illness Events or Mortality|Number of participants who had acute illnesses and mortality during follow-up. The categories of illness events and mortality are not mutually exclusive.|Measured from entry to Week 72 or premature study discontinuation|Due to early study closure, only 59 participants were accrued and followed on study.||Participants|||Count of Participants
802981|NCT00988442|Secondary|Cost of the Adherence Telephone Interventions|This outcome was planned to be analyzed if the intervention was found to be successful. However, the intervention was not determined to be successful.|Week 48|This outcome was not analyzed, since the intervention was not determined to be successful.|||||
802982|NCT00988442|Secondary|Confirmed Virologic Failure|Number of participants with confirmed virologic failure. Virologic failure is defined as confirmed HIV-1 RNA ≥200 copies/mL at or after the week 24 HIV-1 RNA evaluation (obtained at least 20 weeks after the date of randomization).|Week 24 through Week 72|The analysis population was all participants randomized to a treatment arm in this trial.||Participants|||Count of Participants
802987|NCT00988442|Primary|Number of Participants With Virologic Suppression|Number of participants with virologic suppression, defined as HIV-1 RNA at less than 200 copies/mL at week 48.|Week 48|All participants enrolled who had Week 48 HIV-1 RNA results available were included in this intent-to-treat-analysis. At the time of early study closure, 14 participants had reached week 48.||Participants|||Count of Participants
802988|NCT00988533|Primary|Summary of Pharmacokinetic Parameter (Time of Observed Maximum Plasma Concentration) Following Ivermectin Application.|Plasma concentrations of ivermectin were measured by validated and appropriate bioanalytical instruments and methods before application and on Day 1 (0.5, 1, and 6 hours post-application), Day 2 (24 hours post-application), Day 8 (7 days post-application), and Day 15 (14 days post-application).|Before; 0.5, 1, 6, 24 hours, Day 8 and Day 15 post-application|Plasma concentrations of Ivermectin were assessed in the pharmacokinetic (PK) population.||hour||Standard Deviation|Mean
802989|NCT00988533|Primary|Summary of Pharmacokinetic Parameter (Mean Concentration) Following Ivermectin Application.|Plasma concentrations of ivermectin were measured by validated and appropriate bioanalytical instruments and methods before application and on Day 1 (0.5, 1, and 6 hours post-application), Day 2 (24 hours post-application), Day 8 (7 days post-application), and Day 15 (14 days post-application).|Before; 0.5, 1, 6, 24 hours, Day 8 and Day 15 post-application|Plasma concentrations of Ivermectin were assessed in the pharmacokinetic (PK) population.||ng/mL||Standard Deviation|Mean
802990|NCT00988533|Secondary|Liver Function Test Results at Before (Baseline) and Following Ivermectin Application on Days 2, 8, and 15 Post-application|Liver function test (total bilirubin) was performed before treatment Day 1 (baseline) and following Ivermectin application on Days 2, 8, and 15 Post-application, respectively.|Day 1, Day 2, Day 8 and Day 15 post-application|Liver function tests were performed in the intent to treat population.||mg/dL||Standard Deviation|Mean
802991|NCT00988533|Secondary|Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application|Liver function tests (Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, and Lactate Dehydrogenase) were performed before Ivermectin application on Day 1 (baseline) and on Days 2, 8, and 15 after application.|Day 1, Day 2, Day 8 and Day 15 post-application|Liver function tests were performed in the intent to treat population.||U/L||Standard Deviation|Mean
802992|NCT00988533|Secondary|Percentage of Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 8 and Day 15 Post-treatment With Ivermectin.|Eradication of live lice was assessed by visual examination of the scalp and hair before and following application of Ivermectin.|Day 2, Day 8 and Day 15 post-application|Eradication of live lice was assessed in the intent to treat population.||Percent of Participants|||Number
802993|NCT00988533|Secondary|Percentage of Participants Who Were Lice-Free by Visit Post-treatment With Ivermectin.|Eradication of live lice was assessed by visual examination of the scalp and hair.|Day 2, Day 8 and Day 15 post-application|Eradication of live lice was assessed in the intent-to-treat population.||Percent of Participants|||Number
802994|NCT00988533|Secondary|Number of Participants Reporting Adverse Events Following Ivermectin Treatment|Adverse events were assessed at each visit and during the follow up phone call on Day 28.|Day 1 up Day 28 post-application|Adverse events were assessed in the intent-to-treat population.||Participants|||Number
802995|NCT00988533|Primary|Summary of Pharmacokinetic Parameters Following Ivermectin Application.|Plasma concentrations of ivermectin were measured by validated and appropriate bioanalytical instruments and methods before application and on Day 1 (0.5, 1, and 6 hours post-application), Day 2 (24 hours post-application), Day 8 (7 days post-application), and Day 15 (14 days post-application).|Before; 0.5, 1, 6, 24 hours, Day 8 and Day 15 post-application|Plasma concentrations of Ivermectin were assessed in the pharmacokinetic (PK) population.||ng/h/mL||Standard Deviation|Mean
802996|NCT00988533|Primary|Mean Plasma Concentration of Ivermectin in Samples Collected Before Application and at Specified Post-Application Time Points|Plasma concentrations of ivermectin were measured by validated and appropriate bioanalytical instruments and methods with a sensitivity of 0.05 ng/mL before application and on Day 1 (0.5, 1, and 6 hours), Day 2 (24 hours post-application), Day 8 (7 days post-application), and Day 15 (14 days post-application).|Before; 0.5, 1, 6, 24 hours and Up to 14 days post-application|Plasma concentrations of Ivermectin were assessed in the pharmacokinetic (PK) population.||ng/mL||Standard Deviation|Mean
802997|NCT00988637|Secondary|Number of Participants With Tolerability Assessments Resulting in Adverse Events From Baseline to Week 4|Number of participants with Tolerability Assessments resulting in Adverse Events from baseline to week 4. Tolerability assessments (Pruritus, telangiectasias, and stinging/burning) are evaluated on a scale from 0 - 3 (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) with 0 being best and 3 being worst. Skin atrophy and folliculitis are evaluated as absent or present. Changes in tolerability assessments that require a dose modification or concomitant medications/therapy are recorded as adverse events.|Baseline to Week 4|Safety||participants|||Number
802998|NCT00988637|Secondary|"Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question I Would Use This Treatment Program Again if Recommended by the Dermatologist at Week 4"|"Number of participants who responded to the categories of possible answers to the Subject's Satisfaction Survey question I would use this treatment program again if recommended by the dermatologist at Week 4. Categories of possible answers include Strongly agree, Moderately agree, No opinion, Moderately disagree, and Strongly disagree."|Week 4|ITT (Intent to Treat)||participants|||Number
802999|NCT00988637|Secondary|"Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question I am Satisfied With the Results of This Treatment Program at Week 4"|"Number of participants who responded to the categories of possible answers to the Subject's Satisfaction Survey question I am satisfied with the results of this treatment program at Week 4. Categories of possible answers include Strongly agree, Moderately agree, No opinion, Moderately disagree, and Strongly disagree."|Week 4|ITT (Intent to Treat)||participants|||Number
803000|NCT00988637|Secondary|"Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question I am Satisfied With my Appearance at Week 4"|"Number of participants who responded to the categories of possible answers to the Subject's Satisfaction Survey question I am Satisfied with my Appearance at Week 4. Categories of possible answers include Strongly agree, Moderately agree, No opinion, Moderately disagree, and Strongly disagree."|Week 4|ITT (Intent to Treat)||participants|||Number
805555|NCT01004393|Secondary|Time to Laxation After Administration of Subcutaneous Methylnaltrexone||48 hours after the dose of subcutaneous methylnaltrexone|||hours||Standard Error|Mean
803001|NCT00988637|Secondary|"Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question The Treatment Program Was Easy to Follow at Week 4"|"Number of participants who responded to the categories of possible answers to the Subject's Satisfaction Survey question The treatment program was easy to follow at Week 4. Categories of possible answers include Strongly agree, Moderately agree, No opinion, Moderately disagree, and Strongly disagree."|Baseline and Week 4|ITT (Intent to Treat)||participants|||Number
803002|NCT00988637|Secondary|Mean Change From Baseline Scores for the Koo-Menter Psoriasis Index 12-item Quality of Life Questionnaire (PQOL-12) From Baseline to Week 4|Mean change from baseline scores for the Koo-Menter Psoriasis Index 12-item Quality of Life Questionnaire (PQOL-12) from Baseline to Week 4. The Koo-Menter Psoriasis Index is a questionnaire with 12 questions that can be used to assess the effect that psoriasis has on a patient's overall quality of life. The questions are answered on a scale from 0 to 10 with 0 being best and 10 being worst.|Baseline to Week 4|ITT (Intent to Treat)||Units on a scale||Standard Deviation|Mean
803003|NCT00988637|Secondary|Median Percent (%) Change From Baseline in % Treatable BSA (Body Surface Area) From Baseline to Week 4|Median percent (%) change from baseline in % treatable BSA (Body Surface Area) from Baseline to Week 4|Baseline to Week 4|ITT (Intent to Treat); LOCF (Last Observation Carried Forward)||Percent change||Standard Deviation|Median
803004|NCT00988637|Secondary|Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) Scores From Baseline to Week 4|Number of participants with decrease in Signs of Psoriasis (Plaque Elevation) scores from Baseline to Week 4. Signs of Psoriasis (Plaque Elevation) are evaluated on a scale from 0 - 4 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe/Very Severe) with 0 being best and 4 being worst.|Baseline to Week 4|ITT (Intent to Treat); LOCF (Last Observation Carried Forward)||participants|||Number
803005|NCT00988637|Secondary|Number of Participants With Decrease in Signs of Psoriasis (Scaling) Scores From Baseline to Week 4|Number of participants with decrease in Signs of Psoriasis (Scaling) scores from Baseline to Week 4. Signs of Psoriasis (Scaling) are evaluated on a scale from 0 - 4 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe/Very Severe) with 0 being best and 4 being worst.|Baseline to Week 4|ITT (Intent to Treat); LOCF (Last Observation Carried Forward)||participants|||Number
803006|NCT00988637|Secondary|Number of Participants With a Decrease in Signs of Psoriasis (Erythema) Scores From Baseline to Week 4|Number of participants with a decrease in Signs of Psoriasis (Erythema) scores from Baseline to Week 4. Signs of Psoriasis (Erythema) are evaluated on a scale from 0 - 4 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe/Very Severe with 0 being best and 4 being worst.|Baseline to Week 4|ITT (Intent to Treat; LOCF (Last Observation Carried Forward)||participants|||Number
803007|NCT00988637|Secondary|Number of Participants in Each Category of the Global Assessment of Improvement (GAI) Scale From Baseline to Week 4|Number of participants in each category of the Global Assessment of Improvement (GAI) Scale from Baseline to Week 4. The Global Assessment of Improvement is evaluated on a scale from -1 to 4 (-1 = Symptoms worse, 0 = No change, 1 = Minimal Improvement, 2 = Definite Improvement, 3 = Considerable Improvement and 4 = Clearing) with -1 being worst and 4 being best.|Baseline to Week 4|ITT (Intent to Treat); LOCF (Last Observation Carried Forward)||participants|||Number
803008|NCT00988637|Secondary|Number of Participants Who Were a Success (Clear/Almost Clear) of Plaque Psoriasis at Week 2 Based on the Overall Disease Severity (ODS), Dichotomized Scale From Baseline to Week 2|Number of participants who were a success (Clear/Almost Clear) of Plaque Psoriasis at Week 2 based on the Overall Disease Severity (ODS), dichotomized scale from Baseline to Week 2. Overall Disease Severity is evaluated on a scale from 0 - 4 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe/Very Severe) with 0 being best and 4 being worst.|Baseline to week 2|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)||participants|||Number
803009|NCT00988637|Primary|Number of Participants Who Were a Success (Clear/Almost Clear) of Plaque Psoriasis at Week 4 Based on the Overall Disease Severity (ODS), Full Ordinal Scale From Baseline to Week 4|Number of participants who were a success (Clear/Almost Clear) of Plaque Psoriasis at week 4 based on the Overall Disease Severity (ODS), full ordinal scale from baseline to week 4. Overall Disease Severity is evaluated on a scale from 0 - 4 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe/Very Severe) with 0 being best and 4 being worst.|Baseline to Week 4|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)||participants|||Number
803010|NCT00988832|Primary|Mean Cost Per Participant for Diagnostic Tests During Planned Outpatient Consultations|Costs were calculated as those incurred to the National Health Service (NHS) to treat Crohn's Disease. Costs of diagnostic tests conducted during outpatient consultations were calculated as per the 2008-2009 NHS Reference Costs. Costs for diagnostic tests during hospitalizations and A&E visits were incorporated into cost analyses for those categories and are not included here.|12 months prior to and 12, 18, and 24 months after the first infusion of infliximab|||Pounds sterling per participant||Standard Deviation|Mean
803011|NCT00988832|Primary|Mean Cost Per Participant for Crohns-related Medications|Costs of biologics were calculated by multiplying the number of vials of drug used per participant by the 2009 British National Formulary (BNF) cost per vial. Costs of other drugs with ≥10 prescriptions were calculated by multiplying the 2009 BNF daily cost of the standard/most-prescribed dose of the most-prescribed drug (reference drug) in each drug group (Anatomical Therapeutic Classification [ATC] Level 4) by the length of treatment. Costs for drugs in drug groups with ≤9 prescriptions were calculated using the average cost of all Crohns medications multiplied by the length of treatment.|12 months prior to and 12, 18, and 24 months after the first infusion of infliximab|||Pounds sterling per participant||Standard Deviation|Mean
803012|NCT00988832|Primary|Mean Cost Per Participant of Accident and Emergency (A&E) Visits|Costs for visits to A&E without admission. Costs were calculated as those incurred to the National Health Service (NHS) to treat Crohn's Disease as per the 2009 Healthcare Resource Group (HRG) descriptors.|12 months prior to and 12, 18, and 24 months after the first infusion of infliximab|||Pounds sterling per participant||Standard Deviation|Mean
803013|NCT00988832|Primary|Mean Cost Per Participant for All Hospitalizations|"Costs for all hospitalizations, including costs associated with elective
and emergency (non-elective) admissions as well as outpatient procedures."|12 months prior to and 12, 18, and 24 months after the first infusion of infliximab|||Pounds sterling per participant||Standard Deviation|Mean
805556|NCT01004393|Secondary|Laxation After Administration of Subcutaneous Methylnaltrexone||24 and 48 hours after the dose of subcutaneous methylnaltrexone|||percentage of participants||95% Confidence Interval|Number
803014|NCT00988832|Primary|Mean Cost Per Participant for Admissions for Day Case Surgery|Costs were calculated as those incurred to the National Health Service (NHS) to treat Crohn's Disease. Costs of day case (outpatient) surgeries were calculated as per the 2009 Healthcare Resource Group (HRG) descriptors. Costs were analyzed for any surgeries that did not require the participant to stay overnight in the hospital.|12 months prior to and 12, 18, and 24 months after the first infusion of infliximab|||Pounds sterling per participant||Standard Deviation|Mean
803015|NCT00988832|Primary|Mean Cost Per Participant Due to Non-elective/Emergency Inpatient Admissions|Costs were calculated as those incurred to the National Health Service (NHS) to treat Crohn's Disease. Costs of non-elective or emergency inpatient admissions were calculated as per the 2009 Healthcare Resource Group (HRG) descriptors. Costs were analyzed for unplanned hospital admissions due to emergency surgical procedures and unplanned consultations due to complications.|12 months prior to and 12, 18, and 24 months after the first infusion of infliximab|||Pounds sterling per participant||Standard Deviation|Mean
803016|NCT00988832|Primary|Mean Cost Per Participant of Elective Surgical Procedures|Costs were calculated as those incurred to the National Health Service (NHS) to treat Crohn's Disease. Costs of elective surgical procedures were calculated as per the 2009 Healthcare Resource Group (HRG) descriptors. Costs were analyzed for elective surgeries that required participants to be admitted into a hospital.|12 months prior to and 12, 18, and 24 months after the first infusion of infliximab|||Pounds sterling per participant||Standard Deviation|Mean
803017|NCT00988832|Primary|Mean Cost Per Participant of Consultations With Health Care Providers (HCPs)|Costs were calculated as those incurred to the National Health Service (NHS) to treat Crohn's Disease. Costs of outpatient consultations are based on the 2009 Unit Cost of Health and Social Care published by the Personal Social Service Research Unit. Consultations with gastroenterologists, gastric/gastrointestinal surgeons, radiologists, nurses/Inflammatory Bowel Disease nurses, dieticians/nutrition specialists, psychologists/psychiatrists, pharmacists, and occupational therapists are included in the analysis.|12 months prior to and 12, 18, and 24 months after the first infusion of infliximab|||Pounds sterling per participant||Standard Deviation|Mean
803018|NCT00988858|Secondary|PK: Area Under the Plasma Concentration vs. Time Curve From Time Zero to Infinity [AUC(0-∞)] of Pemetrexed||Day 1 and Day 2 of Cycle 1 and Cycle 2: Prior to End of Infusion (EOI); EOI + 1-2 hour (hr); EOI + 4-6- hr; EOI + 20-28 hr|All randomized participants who received at least 1 dose of drug and had evaluable PK data.||microgram*hour per milliliter (µg*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
803019|NCT00988858|Secondary|PK: Area Under the Plasma Concentration vs. Time Curve From Time Zero to Infinity [AUC(0-∞)] of LY2603618||Day 2 and Day 3 of Cycle 1 and Cycle 2: Prior to End of Infusion (EOI); EOI + 1-2 hr; EOI + 4-6 hr; EOI + 20-28 hr; anytime on Day 8 of Cycle 1 and Cycle 2|All randomized participants who received at least 1 dose of drug and had evaluable PK data||nanograms*hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
803020|NCT00988858|Secondary|PK: Maximum Plasma Concentration (Cmax) of Pemetrexed||Day 1 and Day 2 of Cycle 1 and Cycle 2: Prior to End of Infusion (EOI); EOI + 1-2 hour (hr); EOI + 4-6- hr; EOI + 20-28 hr|All randomized participants who received at least 1 dose of drug and evaluable PK data.||microgram per milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
803021|NCT00988858|Secondary|Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY2603618||Day 2 and Day 3 of Cycle 1 and Cycle 2: Prior to End of Infusion (EOI); EOI + 1-2 hr; EOI + 4-6 hr; EOI + 20-28 hr; anytime on Day 8 of Cycle 1 and Cycle 2|All randomized participants who received at least 1 dose of drug and evaluable PK data.||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
803022|NCT00988858|Secondary|Change in Symptom Burden Scores of Lung Cancer Symptom Scale (LCSS)|The LCSS participants scale is a 9-item questionnaire. Six questions are symptom-specific measures for lung cancer (appetite, fatigue, cough, dyspnea, hemoptysis and pain), and 3 summation items describe total symptomatic distress, activity status, and overall quality of life. Participant responses were measured using visual analogue scales (VAS) with 100-milliliter (mm) lines. Scores range from 0 (for best outcome) to 100 (for worst outcome). The Average Symptom Burden Index (ASBI) was calculated as the mean of 6 symptom-specific questions from the LCSS.|Baseline until End of Study (Up to 27.1 Months)|The LCSS evaluable population consisted of all enrolled participants who had a baseline LCSS measurement and at least 1 post-baseline measurement. The population was evaluated for changes in the ASBI (improved, stable, worsened), with improvement/worsening based on trends seen in sets of consecutive ASBI assessments with respect to baseline ASBI.||participants|||Number
803023|NCT00988858|Secondary|Duration of Response|Duration of Response is defined as the time from the first observation of CR or PR to the first observation of progressive disease (PD) or death from any cause. A response is defined as a confirmed objective status of CR or PR. For participants who are not known to have died as of the data inclusion cut-off date and who do not have PD, the duration will be censored at the date of the last objective progression free disease assessment prior to the date of any subsequent anticancer therapy.|First Observation of CR or PR until Progressive Disease or Death Due to Any Cause (Up to 23 Months)|All randomized participants who received at least 1 dose of drug with Best Overall Response of Complete Response or Partial Response.5 participants were censored.||months||90% Confidence Interval|Median
803024|NCT00988858|Secondary|Progression-free Survival (PFS)|Progression-free survival (PFS) time was defined as the time from the date of randomization to the first date of progressive disease (symptomatic or objective) or death due to any cause, whichever occurred first. For participants who were not known to have died or progressed as of the data-inclusion cutoff date, PFS time was censored at the date of the last objective progression-free disease assessment prior to the date of any subsequent systematic anticancer therapy. PFS was summarized using Kaplan-Meier estimates.|Baseline to Progressive Disease or Death Due to Any Cause (Up to 27.1 Months)|All randomized participants who received at least 1 dose of drug. 9 participants were censored.||months||90% Confidence Interval|Median
803046|NCT00989092|Secondary|Hematopoietic Response During the Test Period|The number of participants achieving a hematopoietic response, defined as an increase in hemoglobin from baseline of ≥ 2.0 g/dL or a concentration ≥ 12.0 g/dL both in the absence of red blood cell (RBC) transfusions during the preceding 28 days.|Weeks 1-12|Includes all randomized patients in the darbepoetin alfa arm who received at least 1 dose of study drug or all randomized patients in the observation arm. Patients also needed to have a baseline hemoglobin that was not affected by a red blood cell transfusion.||Participants|||Number
828092|NCT01214395|Secondary|The Number of Patients That Did Not Have a Staphylococcus Aureus Infection||6 months|counted||participants|||Number
803025|NCT00988858|Secondary|Percentage of Participants Who Achieved a Best Response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) (Clinical Benefit Rate)|Clinical benefit rate is the best response CR, PR, or stable disease (SD) as classified by the investigators according to the RECIST v1.1. CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of not-target lesions or appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameter since treatment started. Clinical benefit rate is calculated as a total number of participants with CR, PR, or SD divided by the total number of participants with at least 1 measurable lesion, multiplied by 100.|Baseline until Progressive Disease or Study Discontinuation (Up to 23 Months)|All randomized participants who received at least 1 dose of drug.||percentage of participants||90% Confidence Interval|Number
803026|NCT00988858|Primary|Overall Tumor Response - Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)]|Overall response rate is the best response of complete response (CR) or partial response (PR) as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of not-target lesions or appearance of new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with at least 1 measurable lesion, multiplied by 100.|Baseline until Progressive Disease or Study Discontinuation (Up to 23 Months)|All randomized participants who received at least 1 dose of drug.||percentage of participants||95% Confidence Interval|Number
803027|NCT00988884|Secondary|Geometric Mean Titers of the Antibody Response to Neisseria Meningitidis Serogroups Contained in Menactra™|Serum bactericidal antibodies to Neisseria meningitidis serogroups A, C, Y, and W-135 were measured by incubating serial dilutions of serum with target N. meningitidis strains and complement, and enumerating the surviving bacteria after overnight incubation on blood agar plates. The antibody titer is expressed as the reciprocal of the highest dilution that achieves >50% bacterial killing; a higher value represents a greater antibody response. For the Concomitant Vaccination group, serum samples were collected 4 weeks after Day 1 vaccination; for the Non-concomitant Vaccination group, serum samples were collected 4 weeks after Month 1 vaccination.|4 weeks following Day 1 or Month 1 vaccination|The per-protocol population included participants who received study vaccination and had serum samples available for evaluation of the endpoint||Titer||95% Confidence Interval|Geometric Mean
803028|NCT00988884|Secondary|Percentage of Participants Who Seroconvert for Each of the HPV Types Contained in V503|Blood was drawn at Month 7 and assayed to determine whether or not a participant had achieved seroconversion for the HPV types. The lower limit of the titer (milli Merck U/mL) considered seropositive was as follows: HPV Type 6: >=30, HPV Type 11: >=16; HPV Type 16: >=20, HPV Type 18: >=24, HPV Type 31: >=10, HPV Type 33: >=8, HPV Type 45: >=8, HPV Type 52: >=8, and HPV Type 58: >=8.|Month 7|The per-protocol population included participants who received all study vaccinations, were seronegative to HPV on Day 1, and had serum samples available for evaluation of the endpoint||Percentage of participants|||Number
803029|NCT00988884|Primary|Percentage of Participants With Maximum Temperature >=37.8 °C (>=100.0 °F) (Oral or Oral Equivalent)|For the Concomitant Vaccination group, temperatures were collected after the Day 1 vaccination and the Month 1 visit; for the Non-concomitant Vaccination group, temperatures were collected after the Day 1 vaccination and the Month 1 vaccination.|Up to 5 days following the Day 1 and Month 1 vaccination / visit|The population analyzed included all vaccinated participants with follow-up||Percentage of participants|||Number
803030|NCT00988884|Primary|Percentage of Participants With a Menactra™ or Adacel™ Injection-site Adverse Experience|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Only injection-site AEs in the arm that received Menactra™ and Adacel™ vaccination were reported for this endpoint. For the Concomitant Vaccination group, injection-site AEs are reported following Day 1 vaccination; for the Non-concomitant Vaccination group, injection-site AEs are reported following Month 1 vaccination.|Day 1 through Day 5 following Day 1 or Month 1 vaccination|The population analyzed included all vaccinated participants with follow-up for injection-site AEs||Percentage of participants|||Number
803031|NCT00988884|Primary|Percentage of Participants With a V503 Injection-site Adverse Experience|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Only injection-site AEs in the arm that received V503 vaccination were reported for this endpoint.|Day 1 through Day 5 following Day 1 vaccination|The population analyzed included all vaccinated participants with follow-up for injection-site AEs||Percentage of participants|||Number
803032|NCT00988884|Primary|Geometric Mean Titers of Pertussis Antibody Responses|For the Concomitant Vaccination group, serum samples were collected 4 weeks after the Day 1 vaccination; for the Non-concomitant Vaccination group, serum samples were collected 4 weeks after the Month 1 vaccination. Titers of anti-pertussis toxin (PT), anti-filamentous hemagglutinin (FHA), anti-pertactin (PRN), and anti-fimbriae 2/3 (FM 2/3) antibodies were measured using enzyme-linked immunosorbent assays. The titers were expressed as Enzyme-linked Immunoassay Units (ELU)/mL.|4 weeks following Day 1 or Month 1 vaccination|The per-protocol population included participants who received study vaccination and had serum samples available for evaluation of the endpoint||ELU/mL||Full Range|Geometric Mean
803047|NCT00989092|Secondary|Hemoglobin Response During the Test Period|The number of participants achieving a hemoglobin response, defined as an increase in hemoglobin from baseline of ≥ 2.0 g/dL in the absence of red blood cell (RBC) transfusions during the preceding 28 days.|Weeks 1-12|Includes all randomized patients in the darbepoetin alfa arm who received at least 1 dose of study drug or all randomized patients in the observation arm. Patients also needed to have a baseline hemoglobin that was not affected by a red blood cell transfusion.||Participants|||Number
803033|NCT00988884|Primary|Percentage of Participants Who Achieve Acceptable Titers of Anti-Diphtheria and Anti-Tetanus Antibody|For the Concomitant Vaccination group, serum samples were collected 4 weeks after the Day 1 vaccination; for the Non-concomitant Vaccination group, serum samples were collected 4 weeks after the Month 1 vaccination. Titers of neutralizing antibody to diphtheria toxin were measured using a cell-based Diphtheria Micrometabolic Inhibition assay. The lower limit of quantitation of the assay was defined as 0.01 International Units (IU)/mL. Serum titers of neutralizing antibody to tetanus toxin were measured using an enzyme immunoassay. The lower limit of quantitation of the assay was defined as 0.04 IU/mL. Acceptable titers refer to the World Health Organization-defined protective titers of >=0.1 IU/mL.|4 weeks following Day 1 or Month 1 vaccination|The per-protocol population included participants who received study vaccination and had serum samples available for evaluation of the endpoint||Percentage of participants|||Number
803034|NCT00988884|Primary|Percentage of Participants With >=4-fold Increase in Antibody Titers to Neisseria Meningitidis Serogroups|For the Concomitant Vaccination group, serum samples were collected at Day 1 (baseline) and 4 weeks after the Day 1 vaccination; for the Non-concomitant Vaccination group, serum samples were collected at Month 1 (baseline) and 4 weeks after the Month 1 vaccination. Bactericidal antibodies to Neisseria meningitidis serogroups A, C, Y, and W-135 were measured by incubating serial dilutions of serum with target N. meningitidis strains and complement, and enumerating the surviving bacteria after overnight incubation on blood agar plates. The serum bactericidal titer is reported as the reciprocal of the final serum dilution giving >50% killing in 60 minutes.|Baseline and 4 weeks following Day 1 (Concomitant) or Month 1 (Non-concomitant) vaccination|The per-protocol population included participants who received study vaccination and had serum samples available for evaluation of the endpoint||Percentage of participants|||Number
803035|NCT00988884|Primary|Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503|Serum antibody titers to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 were evaluated using a competitive Luminex immunoassay. Titers are reported in milli Merck Units/mL.|4 weeks following Month 6 vaccination|The per-protocol population included participants who received all study vaccinations, were seronegative to HPV on Day 1, and had serum samples available for evaluation of the endpoint||milli Merck Units/mL||Full Range|Geometric Mean
803036|NCT00989014|Primary|Response Rate for Achieving a 2 Grade Improvement on Clinician's Erythema Assessment (CEA) and Patient Self Assessment (PSA) Over 12 Hours After Dosing.||Baseline and every hour for 12 hours following application|||participants|||Number
803037|NCT00989092|Secondary|Number of Days of Red Blood Cell Transfusions During Weeks 5-12|The number of days when at least one RBC transfusion was administered during Weeks 5 to 12.|Weeks 5-12|Includes all randomized patients in the darbepoetin alfa arm who received at least 1 dose of study drug or all randomized patients in the observation arm, and who were on-study as of the beginning of Week 5 (Study Day 29).||days||Standard Deviation|Mean
803038|NCT00989092|Secondary|Number of Units of Red Blood Cells Transfused During Weeks 5-12|The number of standard units of RBCs transfused during Weeks 5 to 12.|Weeks 5-12|Includes all randomized patients in the darbepoetin alfa arm who received at least 1 dose of study drug or all randomized patients in the observation arm, and who were on-study as of the beginning of week 5 (study day 29).||units of red blood cells||Standard Deviation|Mean
803039|NCT00989092|Secondary|Number of Participants With Red Blood Cell (RBC) Transfusions During Weeks 5-12|The number of participants with at least one RBC transfusion during weeks 5 to 12.|Weeks 5-12|Includes all randomized patients in the darbepoetin alfa arm who received at least 1 dose of study drug or all randomized patients in the observation arm, and who were on-study as of the beginning of Week 5 (Study Day 29).||Participants|||Number
803040|NCT00989092|Secondary|Number of Days of Red Blood Cell Transfusions During the Test Period|The number of days when at least one red blood cell transfusion was administered during Weeks 1 to 12.|Weeks 1-12|Includes all randomized patients in the darbepoetin alfa arm who received at least 1 dose of study drug or all randomized patients in the observation arm.||days||Standard Deviation|Mean
803041|NCT00989092|Secondary|Number of Units of Red Blood Cells Transfused During the Test Period|The average number of standard units of red blood cells transfused during Weeks 1 to 12.|Weeks 1-12|Includes all randomized patients in the darbepoetin alfa arm who received at least 1 dose of study drug or all randomized patients in the observation arm.||units of red blood cells||Standard Deviation|Mean
803042|NCT00989092|Primary|Number of Hospitalizations During the Test Period|Number of times participants were hospitalized as self-reported in the Health Care Utilization portion of the Subject Outcome Questionaire during Weeks 1-12|Weeks 1-12|Includes all randomized patients in the darbepoetin alfa arm who received at least 1 dose of study drug or all randomized patients in the observation arm. Patients also needed to have completed the baseline and at least 1 post-baseline subject outcome questionaire.||hospitalizations||Standard Deviation|Mean
803043|NCT00989092|Primary|Days of Hospitalization During the Test Period|Number of days hospitalized during Weeks 1-12 as self-reported in the Health Care Utilization portion of the Subject Outcome Questionaire; participants who were not hospitalized had a value of 0 days.|Weeks 1-12|Includes all randomized patients in the darbepoetin alfa arm who received at least 1 dose of study drug or all randomized patients in the observation arm. Patients also needed to have completed the baseline and at least 1 post-baseline subject outcome questionaire.||days||Standard Deviation|Mean
803044|NCT00989092|Secondary|Number of Participants With Red Blood Cell (RBC) Transfusions During the Test Period|Number of participants with at least one RBC transfusion during Weeks 1 to 12.|Weeks 1-12|Includes all randomized patients in the darbepoetin alfa arm who received at least 1 dose of study drug or all randomized patients in the observation arm with available data.||Participants|||Number
803045|NCT00989092|Secondary|Change From Baseline in Hemoglobin Level|The difference between hemoglobin concentrations after 12 weeks of treatment and the Baseline hemoglobin concentration value (Study Day 1 sample prior to first dose of darbepoetin alfa).|Baseline (Week 1) and Week 13|Includes all randomized patients in the darbepoetin alfa arm who received at least 1 dose of study drug or all randomized patients in the observation arm. Patients also needed to have a baseline hemoglobin that was not affected by a red blood cell transfusion. LVCF imputation was used.||g/dL||Standard Deviation|Mean
804168|NCT00996892|Secondary|AUC0-24 of Pictilisib on Cycle 1 Day 18 – Stage 1A All Cohorts||Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
803048|NCT00989092|Secondary|Change in Functional Assessment of Cancer Therapy (FACT)-Fatigue Score at Week 13|The FACT-Fatigue scale comprises 13 questions evaluating the impact of anemia on cancer patients with various tumor types receiving chemotherapy. Fatigue scores range from 0 to 52, with a higher score indicating less fatigue.|Baseline (Week 1) and Week 13|Includes all randomized patients in the darbepoetin alfa arm who received at least 1 dose of study drug or all randomized patients in the observation arm. Participants also needed to have completed the baseline and at least 1 post-baseline FACT-Fatigue questionaire. Last Value Carried Forward (LVCF) imputation used.||units on a scale||Standard Deviation|Mean
803049|NCT00989092|Secondary|Total Hospital Costs During the Test Period|The hospital bill database was used to determine the mean total hospital cost per participant during the test period. Participants who were not hospitalized had a cost of $0 imputed.|Weeks 1-12|Includes all randomized patients in the darbepoetin alfa arm who received at least 1 dose of study drug or all randomized patients in the observation arm, and were included in the hospital bill database. Participants who were not hospitalized had a cost of $0 imputed.||dollars||Standard Deviation|Mean
803050|NCT00989092|Primary|Number of Participants Hospitalized During the Test Period|Number of participants hospitalized during Weeks 1-12 as self-reported in the Health Care Utilization portion of the Subject Outcome Questionaire.|Weeks 1- 12|Includes all randomized patients in the darbepoetin alfa arm who received at least 1 dose of study drug or all randomized patients in the observation arm. Patients also needed to have completed the baseline and at least 1 post-baseline subject outcome questionaire.||Participants|||Number
803051|NCT00989157|Primary|T1/2|Half life|0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5, 24, 48. 72|||hours||Standard Deviation|Mean
803052|NCT00989157|Primary|AUCo-inf,|Area under the plasma concentration time curve|0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5, 24, 48. 72|||ng h/mL||Standard Deviation|Mean
803053|NCT00989157|Primary|Tmax|Time to maximum plasma concentration|0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5, 24, 48. 72|||Hours||Standard Deviation|Mean
803054|NCT00989157|Secondary|Emesis|episodes of emesis.|4 days|||number of occurences|||Number
803055|NCT00989157|Primary|Cmax|The difference, if any, in the pharmacokinetics parameters (Cmax) of duloxetine between patients who are nine to fifteen months post Roux-en-Y Bariatric Surgery and control subjects matched for BMI, age and gender.|0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5, 24, 48. 72|||ng/ml||Standard Deviation|Mean
803056|NCT00989196|Secondary|Immunogenicity (Number of Patients That Developed an Inhibitor During the Course of the Study)|Inhibitor activity was determined by the modified Bethesda assay (Nijmegen modification) at study entry, then immediately before both PK cycles, in the 48 hour sample of both PK cycles, after 10 to 15 EDs with human-cl rhFVIII, at the 3-month visit (± 2 weeks), then every 3 months (± 2 weeks) until study completion, and after >50 EDs (except for some patients who may finish the study before they achieve 50 EDs), with human-cl rhFVIII (i.e. at the study completion visit).|study entry, then immediately before both PK cycles, in the 48 hour sample of both PK cycles, after 10 to 15 EDs with human-cl rhFVIII, at the 3-month visit (± 2 weeks), then every 3 months (± 2 weeks) until study completion, and after >50 EDs (except for|||participants|||Number
803057|NCT00989196|Secondary|Efficacy of On-demand Treatment of Bleeding Episodes|"After each infusion of IMP and at the end of a BE, the following efficacy assessment is made by the subject (together with the Investigator in case of on-site treatment):
Excellent: Abrupt pain relief and/or unequivocal improvement in objective signs of bleeding within approximately 8 hours after a single infusion.
Good: Definite pain relief and/or improvement in signs of bleeding within approximately 8 – 12 hours after an infusion requiring up to 2 infusions for complete resolution.
Moderate: Probable or slight beneficial effect within approximately 12 hours after the first infusion requiring more than two infusions for complete resolution.
None: No improvement within 12 hours, or worsening of symptoms, requiring more than 2 infusions for complete resolution.
The assessment was made at the end of a BE in case more than one infusion was needed."|From 1st treatment after PK cycle 2 until study end.|||percentage of bleeding episodes|Participants||Number
803058|NCT00989196|Secondary|Clearance (CL) for Human-cl rhFVIII Compared to Kogenate FS|After the infusion of 50IU/kg bw of Human-cl rhFVIII and Kogenate FS respectively, FVIII activity levels were measured at various time points before and after the infusion. FVIII level results derived from the chromogenic FVIII assay were used to calculate the mean of the area under the curve normalized to the dose administered.|At baseline (prior to infusion), 0.25, 0.5, 0.75, 1, 3, 6, 9, 12, 24, 30 and 48 hours after the end of the infusion.|||mL/h/kg||Standard Deviation|Mean
803059|NCT00989196|Secondary|Volume of Distribution at Steady State (Vss) for Human-cl rhFVIII Compared to Kogenate FS|After the infusion of 50IU/kg bw of Human-cl rhFVIII and Kogenate FS respectively, FVIII activity levels were measured at various time points before and after the infusion. FVIII level results derived from the chromogenic FVIII assay were used to calculate the mean of the area under the curve normalized to the dose administered.|At baseline (prior to infusion), 0.25, 0.5, 0.75, 1, 3, 6, 9, 12, 24, 30 and 48 hours after the end of the infusion.|||mL/kg||Standard Deviation|Mean
803060|NCT00989196|Secondary|Mean Residence Time (MRT) for Human-cl rhFVIII Compared to Kogenate FS|After the infusion of 50IU/kg bw of Human-cl rhFVIII and Kogenate FS respectively, FVIII activity levels were measured at various time points before and after the infusion. FVIII level results derived from the chromogenic FVIII assay were used to calculate the mean of the area under the curve normalized to the dose administered.|At baseline (prior to infusion), 0.25, 0.5, 0.75, 1, 3, 6, 9, 12, 24, 30 and 48 hours after the end of the infusion.|||hours||Standard Deviation|Mean
803061|NCT00989196|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) for Human-cl rhFVIII Compared to Kogenate FS|After the infusion of 50IU/kg bw of Human-cl rhFVIII and Kogenate FS respectively, FVIII activity levels were measured at various time points before and after the infusion. FVIII level results derived from the chromogenic FVIII assay were used to calculate the mean of the area under the curve normalized to the dose administered.|At baseline (prior to infusion), 0.25, 0.5, 0.75, 1, 3, 6, 9, 12, 24, 30 and 48 hours after the end of the infusion.|||hours||Standard Deviation|Mean
803192|NCT00982020|Secondary|Mean Clinical Global Impression of Improvement (CGI-I) at 52 Weeks for All Participants|The Clinical Global Impression of Improvement (CGI-I) is used by the clinician to record the improvement of illness at the time of assessment. The score ranges from 1 (very much improved) to 7 (very much worse).|52 weeks|All randomized participants who received at least one dose of study drug. Mixed model repeated measures (MMRM) methodology.||units on a scale||Standard Error|Least Squares Mean
803062|NCT00989196|Secondary|Maximum Plasma Concentration (Cmax) for Human-cl rhFVIII Compared to Kogenate FS|After the infusion of 50IU/kg bw of Human-cl rhFVIII and Kogenate FS respectively, FVIII activity levels were measured at various time points before and after the infusion. FVIII level results derived from the chromogenic FVIII assay were used to calculate the mean of the area under the curve normalized to the dose administered.|At baseline (prior to infusion), 0.25, 0.5, 0.75, 1, 3, 6, 9, 12, 24, 30 and 48 hours after the end of the infusion.|||IU/mL||Standard Deviation|Mean
803063|NCT00989196|Secondary|Pharmacokinetic Parameter: Invivo Half-life (T1/2) for Human-cl rhFVIII Compared to Kogenate FS|After the infusion of 50IU/kg bw of Human-cl rhFVIII and Kogenate FS respectively, FVIII activity levels were measured at various time points before and after the infusion. FVIII level results derived from the chromogenic FVIII assay were used to calculate the mean of the area under the curve normalized to the dose administered.|At baseline (prior to infusion), 0.25, 0.5, 0.75, 1, 3, 6, 9, 12, 24, 30 and 48 hours after the end of the infusion.|||hours||Standard Deviation|Mean
803064|NCT00989196|Primary|The Area Under the Concentration Curve for Human-cl rhFVIII Compared to Kogenate FS|After the infusion of 50IU/kg bw of Human-cl rhFVIII and Kogenate FS respectively, FVIII activity levels were measured at various time points before and after the infusion. FVIII level results derived from the chromogenic FVIII assay were used to calculate the mean of the area under the curve normalized to the dose administered.|At baseline (prior to infusion), 0.25, 0.5, 0.75, 1, 3, 6, 9, 12, 24, 30 and 48 hours after the end of the infusion.|||h IU/mL (IU/kg)||Standard Deviation|Mean
803065|NCT00989235|Secondary|Participants With Positive Antibody Responses to Abatacept (Electrochemiluminescence [ECL] Method) During Double-Blind Treatment|A positive antibody response to Abatacept (measured by the ECL assay) is further classified as a positive response for either Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) and Possibly immunoglobulin (Ig)' or 'Ig and/or Junction Region'|After 12 months of treatment|Number of participants analyzed= Number of participants with available immunogenicity measurements||participants|||Number
803066|NCT00989235|Secondary|Clinically Significant Changes in Vital Signs and Physical Findings|Clinical significance was determined by investigator. Parameters include blood pressure, heart rate, respiration rate, and temperature.|From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks)|This analysis was not done because clinically significant changes in vital signs and physical findings were reported as adverse events.||participants|||Number
803067|NCT00989235|Secondary|Percentage of Participants With Laboratory Values Meeting the Marked Abnormality Criteria During Double-Blind Treatment|Not evaluated: high hemoglobin,high hematocrit,high erythrocytes,high neutrophils+bands(N+B),low monocytes,low basophils,low eosinophils,low alkaline phosphatase(ALP),low aspartate aminotransferase(AST),low alanine aminotransferase(ALT),low G-Glutamyl transferase(GGT),low total bilirubin,low blood urea nitrogen,low creatinine,high albumin,low uric acid,low urine protein,low urine glucose,low urine blood,low urine leukocyte esterase,low urine white blood cells,low red blood cells.Pre Rx=pretreatment,(*)Lymphocytes(c/uL):Low<.750x10^3,High>7.50x10^3.(*)Eosinophils:>.750x10^3 c/uL.|From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks)|Number of participants analyzed = All treated participants during the double-blind period; n=number of participants with specific measure||percentage of participants|||Number
803068|NCT00989235|Secondary|Percentage of Participants With Pre-specified Autoimmune Disorders (ADs) Reported During Double-Blind Treatment, by Intensity|A total of 127 autoimmune disorders were prespecified in the protocol. MCTD=Musculoskeletal and Connective Tissue Disorders|From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks)|Number of participants analyzed = All treated participants during the double-blind period.||percentage of participants|||Number
803069|NCT00989235|Secondary|Percentage of Participants With Prespecified Peri-Infusional Adverse Events (PAIAEs) During Double-Blind Treatment, by Intensity|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Peri-infusional AE=a pre-specified infusional AE occuring during the first 24 hours after the start of study drug infusion.A total of 105 infusional events were prespecified in the protocol. GDASC=General Disorders and Administration Site Conditions, RTMD=Respiratory, Thoracic and Mediastinal Disorders.|From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks)|Number of participants analyzed = All treated participants during the double-blind period.||percentage of participants|||Number
803070|NCT00989235|Secondary|Percentage of Participants With Prespecified Acute Infusional Adverse Events (AIAEs) During Double-Blind Treatment, by Intensity|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Acute Infusional AE= a subset of the peri-infusional AEs with onset during the first hour after the start of the study drug infusion. A total of 105 infusional events were prespecified in the protocol.|From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks)|Number of participants analyzed = All treated participants during the double-blind period.||percentage of participants|||Number
803071|NCT00989235|Secondary|Percentage of Participants With Malignant Neoplasms Reported During Double-Blind Treatment|All neoplasms were assessed by medical review as to whether or not the event was malignant.|From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks)|Number of participants analyzed = All treated participants during the double-blind period.||percentage of participants|||Number
803189|NCT00982020|Secondary|Mean Change From Baseline to 52 Weeks in Anchored Version of the Brief Psychiatric Rating Scale for Children (BPRS-C) for Participants With Schizophrenia|The BPRS-C characterizes psychopathology. A total of 21 items are rated on a scale from 0 (not present) to 6 (extremely severe) with a total score ranging from 0 to 126. A decrease in score indicates a reduction in psychopathology.|Baseline, 52 weeks|All randomized participants with schizophrenia who received at least one dose of study drug. Mixed model repeated measures (MMRM) methodology.||units on a scale||Standard Error|Least Squares Mean
803072|NCT00989235|Secondary|Percentage of Participants With Infection and Infestation AEs Reported During Double-Blind Treatment|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Infection and Infestation AEs = any AE within the System Organ Class Infection and Infestation.|From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks)|Number of participants analyzed = All treated participants during the double-blind period.||percentage of participants|||Number
803073|NCT00989235|Secondary|Percentage of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations During Double-Blind Treatment|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Related AE/SAE=Certain, Probable, Possible, or Missing. SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.|From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks)|Number of participants analyzed = All treated participants during the double-blind period.||percentage of participants|||Number
803074|NCT00989235|Secondary|Steady-state Trough Serum Concentration (Cmin) of Abatacept During Double-Blind Treatment||Day 701 of the main study; sub-study Days 1, 85, 169, 253|Number of participants analyzed= number of participants randomized; n =randomized participants with measurement at given time point. For the Day 701 measure, one apparent outlier sample was deleted..||ng/mL||Standard Deviation|Mean
803075|NCT00989235|Secondary|Percentage of Participants Who Lost Remission Status|Loss of remission is defined as DAS 28 CRP >=2.6.|After 12 months of treatment|Number of participants analyzed= number of participants randomized.||percentage of participants||95% Confidence Interval|Number
803076|NCT00989235|Secondary|Percentage of Participants Who Modified Therapy During Double-Blind Treatment|Modified therapy=additional DMARD therapy, 2 or more courses of high dose steroids or rescue medication. Additional DMARD therapy=re-introduction of methotrexate (MTX), an increase of at least 2.5 mg of MTX, or the addition of at least 1 DMARD. A course of high dose steroids=a course of intramuscular, intravenous, or high dose oral corticosteroids (use of > 10 mg/day equivalent of prednisone for a minimum of 3 consecutive days or for those subjects who had continued use for long durations of time, each course was determined by 28 day intervals). Rescue medication=abatacept 10 mg/kg.|After 12 months of treatment|Number of participants analyzed= number of participants randomized.||percentage of participants||95% Confidence Interval|Number
803077|NCT00989235|Secondary|Percentage of Participants Given Rescue Medication Therapy During Double-Blind Treatment|All subjects in the sub-study randomized to receive double-blind abatacept 5 mg/kg or 10 mg/kg. Subjects rescued to open-label treatment received abatacept 10 mg/kg.|After 12 months of treatment|Number of participants analyzed= number of participants randomized.||percentage of participants||95% Confidence Interval|Number
803078|NCT00989235|Primary|Time to Disease Relapse Through Month 12 (Kaplan-Meier Cumulative Percentage of Events of Disease Relapse)|An event of disease relapse was defined as additional Disease-modifying antirheumatic drug (DMARD) therapy given, or 2 or more courses of high steroids given, or return to abatacept 10 mg/kg (rescue medication given), or DAS28 C-reactive protein (CRP) score >=3.2 at 2 consecutive visits. Time to disease relapse was evaluated using life tables (Kaplan-Meier Cumulative Percentage of Events of Disease Relapse).|Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12|Number of participants analyzed=number of participants randomized. n=number of participants at risk at the end of a specified month.||Percentage of Events|||Number
803079|NCT00989235|Secondary|Percentage of Participants Who at Any Time During Double-Blind Treatment Were Given 2 or More Courses of High-Dose Steroids|A course of high dose steroids is defined as a course of intramuscular, intravenous, or high dose oral corticosteroids (use of > 10 mg/day equivalent of prednisone for a minimum of 3 consecutive days or for those subjects who had continued use for long durations of time, each course was determined by 28 day intervals).|After 12 months of treatment|Number of participants analyzed= number of participants randomized.||percentage of participants|||Number
803080|NCT00989235|Secondary|Percentage of Participants Given Additional DMARD Therapy During Double-Blind Treatment|Additional DMARD therapy is defined as a re-introduction of methotrexate (MTX), an increase of at least 2.5 mg of MTX, or the addition of at least 1 DMARD.|After 12 months of treatment|Number of participants analyzed= number of participants randomized.||percentage of participants||95% Confidence Interval|Number
803081|NCT00989235|Secondary|Percentage of Participants With 2 Consecutive DAS 28 CRP Scores ≥ 3.2 (Loss of Low Disease Activity Status)|DAS 28 is a continuous variable which is a composite of 4 variables: number of tender joints out of 28, number of swollen joints out of 28 joints, CRP in mg/L and subject assessment of disease activity measure on a VAS of 100 mm. The DAS28 provides a score on a scale from 0 to 10 indicating the current activity of the rheumatoid arthritis (>5.1=high disease activity; <3.2=low disease activity; <2.6=remission).|After 12 months of treatment|Number of participants analyzed= number of participants randomized.||percentage of participants||95% Confidence Interval|Number
803082|NCT00989235|Secondary|Adjusted Mean Change From Baseline in DAS28 CRP During Double-Blind Treatment|Mean baseline DAS28 CRP values for the cohort of participants with serum samples available at that timepoint. DAS 28 is a continuous variable which is a composite of 4 variables: number of tender joints out of 28, number of swollen joints out of 28 joints, CRP in mg/L and subject assessment of disease activity measure on a VAS of 100 mm. The DAS28 provides a score on a scale from 0 to 10 indicating the current activity of the rheumatoid arthritis (>5.1=high disease activity; <3.2=low disease activity; <2.6=remission).|Baseline, Days 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365|Number of participants analyzed=number of participants randomized; n=the number of participants with available DAS28 CRP scores at that time point.||units on a scale||Standard Error|Mean
803190|NCT00982020|Secondary|Mean Change From Baseline to 52 Weeks in Clinical Global Impression - Severity (CGI-S) for All Participants|The CGI-S is used by the clinician to record the severity of illness at the time of assessment. The score ranges from 1 = normal, not at all ill to 7 = among the most extremely ill.|Baseline, 52 weeks|All randomized participants who received at least one dose of study drug. Mixed model repeated measures (MMRM) methodology.||units on a scale||Standard Error|Least Squares Mean
803083|NCT00989235|Secondary|Mean Time-Matched Baseline DAS28 CRP Scores|Mean baseline DAS28 CRP values for the cohort of participants with serum samples available at that timepoint. DAS 28 is a continuous variable which is a composite of 4 variables: number of tender joints out of 28, number of swollen joints out of 28 joints, CRP in mg/L and subject assessment of disease activity measure on a visual analogue scale (VAS) of 100 mm. The DAS28 provides a score on a scale from 0 to 10 indicating the current activity of the rheumatoid arthritis (>5.1=high disease activity; <3.2=low disease activity; <2.6=remission).|Baseline|Number of participants analyzed=number of participants randomized; n=All treated participants with available DAS28 CRP scores at that time point. Mean time-matched baseline values reflect changing n-values over time.||units on a scale||Standard Deviation|Mean
803084|NCT00989235|Secondary|Number of Participants Experiencing Disease Relapse|Disease relapse is defined as additional DMARD therapy given, or 2 or more courses of high steroids given, or return to abatacept 10 mg/kg (rescue medication given), or DAS28 CRP score >= 3.2 at 2 consecutive visits.|After 12 Months of treatment|Number of participants analyzed=number randomized.||Participants|||Number
803085|NCT00989586|Secondary|Monitor Human Anti-veltuzumab Antibodies and Human Anti-milatuzumab (HAHA)|Patients will be monitored for the development of human anti-veltuzumab antibodies and human anti-milatuzumab antibodies (HAHA).|up to 36 weeks|HAHA titres were assayed for patients in Phase I and Phase II||patients|||Number
803086|NCT00989586|Secondary|Access Pharmacokinetics Through Cmax|Evaluation of pharmacokinetics of veltuzumab and milatuzumab was performed for patients included in the trial. Statistically, descriptive data of PK parameters will be computed. Relationships between such parameters as dose and AUC, volume of distribution, clearance, and others will be evaluated, but be preliminary due to the small sample size.|0, 24, 48, 72, 96 and 120 hours post-dose|Cmax for patients dosed at 20 mg/kg||ug/ml||Standard Deviation|Mean
803087|NCT00989586|Secondary|Access Pharmacokinetics Through AUC0–∞ (Area Under Curve)|Evaluation of pharmacokinetics (Pk) of veltuzumab and milatuzumab was performed for patients included in the trial. Statistically, descriptive data of PK parameters will be computed. Relationships between such parameters as dose and AUC, volume of distribution, clearance, and others will be evaluated, but be preliminary due to the small sample size.|0, 24, 48, 72, 96 and 120 hours post-does|AUC0–∞ for patients dosed at 20 mg/kg||d*ug/ml||Standard Deviation|Mean
803088|NCT00989586|Secondary|Quantitative T-, B-, and NK-cell Subsets Using Flow Cytometry|Quantitative T-, B-, and NK- cell subsets will be assessed using flow cytometry to quantify the percentage and absolute number of cells expressing CD4, CD8, CD56, CD16, CD19, and CD20 at screening, after induction, and prior to the start of therapy on day 1 week 12, day 1 week 28, and then every 4 months for one year.|up to 1 year|This data is not available due to analysis was not performed. The response rate was to low for the analysis to yield results to report for this trial.|||||
803089|NCT00989586|Secondary|Fcγ-receptor Polymorphism Response to Treatment|The relationship between overall response rate (ORR) and Fcy receptor status. A two-sided chi-square test or exact test with α = 0.05 will be used to test the homogeneity of the ORR among the three genotypes.|up to 2 years|This data is not available due to analysis was not performed. The response rate was to low for the analysis to yield results to report for this trial.|||||
803090|NCT00989586|Secondary|Progression-free Survival (PFS)|Progression is defined using International Response Criteria (Cheson JCO 2007), as a >= 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or at least a 50% increase in the longest diameter of any single previously identified node more than 1 cm in its short axis, or the size of other lesions (eg, splenic or hepatic nodules), or the appearance of new lesions.|up to 2 years|||months||95% Confidence Interval|Median
803091|NCT00989586|Primary|Overall Objective Response Rate|Per International Response Criteria (Cheson JCO 2007) for target lesions and assessed by CT, MRI or PET: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses; Overall Response (OR) = CR + PR.|Up to 2 years|||percent of patients|||Number
803092|NCT00989586|Primary|Maximum Tolerated Dose (MTD)for Phase I Patients|Patients received a fixed dose of Veltuzumab IV 200 mg/m2 and Milatuzumab was dose escalated|up to 2 years|||mg/kg|||Number
803093|NCT00989586|Primary|Dose Limiting Toxicity (DLT) for Phase I Patients|Dose-limiting toxicity was assessed during induction therapy for phase I.|up to 2 years|||patients|||Number
803094|NCT00989664|Secondary|Number of Participants With Hypothyroidism Prior to Therapy and After the Therapeutic Dose|Thyroid function was determined periodically, including during follow-up, in order to assess if there was any effect of the Iodine 131 on thyroid function. Hypothyroidism is a condition in which the thyroid gland does not make enough thyroid hormone.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. Participants who were evaluable for thyroid function assessment were analyzed.||participants|||Number
803095|NCT00989664|Secondary|Number of Participants With the Indicated Grade 3 or Grade 4 Hematologic Toxicities|Adverse events were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No adverse event or within normal limits; 1 = Mild adverse event; 2 = Moderate adverse event; 3 = Severe and undesirable adverse event; 4 = Life-threatening or disabling adverse event; 5 = Death related to adverse event. Grade 3/4 hematological toxicities: hemoglobin <8.0 g/dL; platelets <50,000 cells per millimeters (mm)^3; ANC <1000 cells per mm^3; WBC <2000 cells per mm^3.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population||participants|||Number
803096|NCT00989664|Secondary|Time to HAMA Positivity From the First Dosimetric Dose|HAMA are human immunoglobulins with specificity for mouse immunoglobulins. HAMA assays were conducted in the laboratory to measure conversion to HAMA positivity following treatment. Time to HAMA positivity was calculated as the difference between the day on which HAMA positivity occurred and the first dosimetric dose administration day.|HAMA was measured at baseline; Day5; Weeks 7, 17, 25; and then every 12 months while in study BEX104526. Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. Participants who converted from being negative for HAMA at Baseline to being positive for HAMA following treatment were analyzed.||days||Full Range|Median
805557|NCT01004393|Primary|Rescue-free Laxation After Administration of Subcutaneous Methylnaltrexone||4 hours after the dose of subcutaneous methylnaltrexone|||percentage of participants||95% Confidence Interval|Number
803097|NCT00989664|Secondary|Number of Participants Who Were Negative for Human Anti-murine Antibodies (HAMA) at Baseline (Before Receiving the Dosimetric Dose) But Positive or Negative After Receiving the Dosimetric Dose|"The administration of murine antibodies may form HAMA. A HAMA assay was performed using the ImmunoSTRIP HAMA IgG enzyme-linked immune absorbent assay by a central laboratory (Covance Classic Laboratory Services, Indianapolis, IN). Fludarabine, a known immunosuppressant, might decrease HAMA production in addition to reducing bone marrow involvement. To be positive, a participant had to have a positive HAMA assessment at any follow-up visit."|HAMA was measured at baseline; Day5; Weeks 7, 17, 25; and then every 12 months while in study BEX104526. Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. Only those participants evaluable for HAMA were analyzed.||participants|||Number
803098|NCT00989664|Secondary|Number of Participants With an Infection for Which Anti-infectives Were Administered|Anti-infectives are capable of acting against infection, by inhibiting the spread of an infectious agent or by killing the infectious agent outright. Anti-infective is a general term that encompasses antibacterials, antibiotics, antifungals, antiprotozoans, and antivirals.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. Only those participants who had an infection during the study and during the follow-up period were analyzed.||participants|||Number
803099|NCT00989664|Secondary|Number of Participants With the Indicated Type of Infection|An infection is the colonization of a host organism by a parasite species. Infecting parasites seek to use the host's resources to reproduce, often resulting in disease. Specimen samples of the body fluid are cultured for testing whether the infectious organism is present and grown in the culture media to assess the growth pattern of the organisms present in the specimen. The culture results could be positive or negative. The positive culture results indicate that the tested participant has the infection under investigation, in which case therapeutic treatment with anti-infective is required.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. Only those participants who experienced any infection were analyzed.||participants|||Number
803100|NCT00989664|Secondary|Number of Participants With the Indicated SAEs Related to Study Drug|An SAE is any event occurring at any dose that results in any of the following: death, a life-threatening adverse drug experience (ADE; at immediate risk of death from the experience as it occurred), inpatient hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, or a congenital anomaly/birth defect. Medical events that may not result in death, be life threatening, or require hospitalization may be considered to be a serious ADEs when based upon appropriate medical judgment. Relatedness was based on the Investigator's medical judgement.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. All participants who experienced SAEs were analyzed.||participants|||Number
803101|NCT00989664|Secondary|Number of Participants With the Indicated Fatal SAEs Related to Study Drug|An SAE is any event occurring at any dose that results in any of the following: death, a life-threatening adverse drug experience (ADE; at immediate risk of death from the experience as it occurred), inpatient hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, or a congenital anomaly/birth defect. Medical events that may not result in death, be life threatening, or require hospitalization may be considered to be a serious AEs when based upon appropriate medical judgment. Relatedness was based on the Investigator's medical judgement.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. All participants who experienced fatal SAEs were analyzed.||participants|||Number
803102|NCT00989664|Secondary|Number of Participants With the Indicated Fatal Serious Adverse Events (SAE) Unrelated to Study Drug|An SAE is any event occurring at any dose that results in any of the following: death, a life-threatening adverse drug experience (ADE; at immediate risk of death from the experience as it occurred), inpatient hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, or a congenital anomaly/birth defect. Medical events that may not result in death, be life threatening, or require hospitalization may be considered to be a serious ADEs when based upon appropriate medical judgment. Relatedness was based on the Investigator's medical judgment.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. All participants who experienced fatal SAEs were analyzed.||participants|||Number
803103|NCT00989664|Secondary|Number of Participants With the Indicated Time to Death From the Last Dose of Study Drug|Time to death from the last dose of study drug is the time period difference between when study drug treatment stopped and when death occurred.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. All participants who died during the study were analyzed.||participants|||Number
803104|NCT00989664|Secondary|Number of Participants With the Indicated Primary Cause of Death|The primary cause of death of the participants was assessed by the Investigator.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. All participants who died during the study were analyzed.||participants|||Number
803105|NCT00989664|Secondary|Number of Participants With the Indicated Grade 3 or Grade 4 AEs Related to Study Drug and Experienced by at Least 5% of Participants|AEs were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No AE or within normal limits; 1 = Mild AE; 2 = Moderate AE; 3 = Severe and undesirable AE; 4 = Life-threatening or disabling AE; 5 = Death related to AE. The Investigator assessed whether the AE was possibly or probably related to study drug. In addition, all laboratory-derived hematologic toxicities (values outside the normal range) were assumed to be possibly or probably related to study drug.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. All participants who experienced Grade 3 or 4 AEs related to study drug were analyzed.||participants|||Number
803191|NCT00982020|Secondary|Mean Change From Baseline to 52 Weeks in Waist Circumference for All Participants||Baseline, 52 weeks|All randomized participants who received at least one dose of study drug.||centimeters (cm)||Standard Error|Least Squares Mean
803106|NCT00989664|Secondary|Number of Participants With the Indicated Grade 3 or Grade 4 AEs Experienced by at Least 5% of Participants|AEs were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No AE or within normal limits; 1 = Mild AE; 2 = Moderate AE; 3 = Severe and undesirable AE; 4 = Life-threatening or disabling AE; 5 = Death related to AE.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. All participants who experienced Grade 3 or Grade 4 AEs were analyzed.||participants|||Number
803107|NCT00989664|Secondary|Number of Participants With the Indicated Adverse Events (AE) Related to Study Drug Experienced by at Least 5% of Participants|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The Investigator assessed whether the adverse event was related to study drug.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. All participants who experienced any AE related to study drug were analyzed.||participants|||Number
803108|NCT00989664|Secondary|Number of Participants With Responses of CR, CCR, CR+CCR, and PR Following TST and I 131 TST and Following the LQCR, as Assessed by the Investigator|Participants with response include those with CR, CCR, or PR. Criteria for CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. Criteria for CCR: complete resolution of all disease-related symptoms, but residual foci, thought to be residual scar tissue, are present. Criteria for PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions with no new lesions.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. Only those participants evaluable for response were analyzed.||participants|||Number
803109|NCT00989664|Secondary|Overall Survival|Overall survival is defined as the time from the treatment start date to the date of death from any cause.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. Only those participants who died during the study and during the follow-up period were analyzed.||months||95% Confidence Interval|Median
803110|NCT00989664|Secondary|Time to Treatment Failure, as Assessed by the Investigator|Time to treatment failure is defined as the length of time from the date of enrollment to the first incidence of treatment withdrawal, study removal, progression, and/or alternative therapy for the participant's lymphoma, or death.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. Only those participants who experienced treatment failure were analyzed.||months||95% Confidence Interval|Median
803111|NCT00989664|Secondary|Time to Progression of Disease or Death, as Assessed by the Investigator|Time to progression or progression-free survival is defined as the time from the dosimetric dose to the first documented occurrence of disease progression or death. Disease progression is defined as a >=25% increase from the nadir value (lowest laboratory value recorded following administration of the study medication) of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be >2 cm in diameter by radiographic evaluation or >1 cm in diameter by physical examination.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. Only those participants who experienced disease progression or died were analyzed.||months||95% Confidence Interval|Median
803112|NCT00989664|Secondary|Number of Participants With Any Confirmed Response (CR, CCR, or PR), Confirmed CR, Confirmed CCR, Confirmed CR+CCR, and Confirmed PR, as Assessed by Investigator|Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Par. with confirmed response include those with CR, CCR , or PR. A confirmed response (CR/CCR/PR) had to be confirmed by a consecutive response (>=28 days [ 4 weeks] later) that was the same or better. Individual confirmed response data only counts that response confirmed by the same response; thus, not all possible combinations are represented.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. Only those participants evaluable for confirmed response were analyzed.||participants|||Number
803113|NCT00989664|Secondary|Number of Participants With Any Uncofirmed Response (CR, Clinical Complete Response [CCR], or PR), CR, CCR, CR+CCR, and PR), as Assessed by the Investigator|Participants with response include those with CR, CCR, or PR. Criteria for CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. Criteria for CCR: complete resolution of all disease-related symptoms, but residual foci, thought to be residual scar tissue, are present. Criteria for PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions with no new lesions.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. Only those participants evaluable for response were analyzed.||participants|||Number
803114|NCT00989664|Primary|Duration of Response for Par. Receiving TST and I 131 TST With a Response >=30 Days Versus the Number of Par. With a Response >=30 Days After Their LQCR, as Assessed by the MIRROR Panel|Duration of response is defined as the time from the first documented response (for par. with complete response, complete response unconfirmed, or partial response) until disease progression (DP). DP is defined as a >=25% increase from the nadir value (lowest laboratory value recorded following administration of the study medication) of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be >2 centimeters (cm) in diameter by radiographic evaluation or >1 cm in diameter by physical examination.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. Only those participants with complete response, complete response unconfirmed, or partial response were analyzed.||months||95% Confidence Interval|Median
803238|NCT00982280|Secondary|Clinical Global Impression of Change|In the Clinical Global Impression of Change (CGIC) the clinician indicates the perceived change over the treatment period. The clinician is requested to choose one of seven categories. Scores range from very much improved to very much worse.|Baseline; End of Week 12 (12 Weeks)|Intention to treat (ITT).||participants|||Number
803115|NCT00989664|Primary|Number of Participants (Par.) Receiving TST and I 131 TST With a Response >=30 Days Versus Par. With a Response >=30 Days After Their Last Qualifying Chemotherapy Regimen (LQCR), Masked Independent Randomized Radiology and Oncology Review (MIRROR) Panel|Par. with response are those with complete response (CR; complete resolution of all disease-related radiological abnormalities and the disappearance of all signs/symptoms related to disease), complete response unconfirmed (CRu; meets characteristics of CR, except the nodal size hasn’t regressed sufficiently, or there is indeterminate bone marrow), or partial response (PR; >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions with no new lesions). Participants' LQCR was used as a comparator for subsequent treatment with Iodine I 131TST.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population||participants|||Number
803116|NCT00989768|Secondary|ECMAP in m. Frontialis|The measurement of the ECMAP(Evoked Compound Muscle Action Potentials) used surface electrodes on the forehead and electrical stimulation of the facial nerve, according to standard neurophysiological procedures. The amplitude of the ECMAP in the m. frontalis on stimulation of the facial nerve was performed by an experienced neurologist. ECMAP was assessed by an electromyography (EMG) device (TECA Sapphire - TECA Corp., Pleasantville, NY).|112 days|||microVolts||Standard Deviation|Mean
803117|NCT00989768|Secondary|ECMAP in m. Frontialis|The measurement of the ECMAP(Evoked Compound Muscle Action Potentials) used surface electrodes on the forehead and electrical stimulation of the facial nerve, according to standard neurophysiological procedures. The amplitude of the ECMAP in the m. frontalis on stimulation of the facial nerve was performed by an experienced neurologist. ECMAP was assessed by an electromyography (EMG) device (TECA Sapphire - TECA Corp., Pleasantville, NY).|28 days|||microvolts||Standard Deviation|Mean
803118|NCT00989768|Primary|Horizontal Action Halo Diameter at 112 Days|The colorful complex formed by Minor’s test allows the visualization of the area covered by the effects of botulinum toxin on sweat glands, also known as action halos. The horizontal diameter at day 112 were expressed in centimeters and quantified by the software Mirror® (Canfield Scientific Inc., USA).|112 days|||centimeter||Standard Deviation|Mean
803119|NCT00989768|Primary|Horizontal Action Halo Diameter at 28 Days|The colorful complex formed by Minor’s test allows the visualization of the area covered by the effects of botulinum toxin on sweat glands, also known as action halos. The horizontal diameter at day 28 were expressed in centimeters and quantified by the software Mirror® (Canfield Scientific Inc., USA).|28 Days|||centimeter||Standard Deviation|Mean
803120|NCT00989833|Secondary|Number of Participants With an Adverse Event During the Study||6 weeks|The Full Analysis Set (FAS) comprises all randomized patients regardless of whether they took IP or not and for whom data had been recorded in the CRF after randomization.||Participants|||Number
803121|NCT00989833|Secondary|Diary Recording of Asthma Symptoms|Asthma symptoms during days with exercise|6 weeks|The Full Analysis Set (FAS) comprises all randomized patients regardless of whether they took IP or not and for whom data had been recorded in the CRF after randomization.||Percent of exercise days||Standard Deviation|Mean
803122|NCT00989833|Secondary|Asthma Control Measured by a 5-item Asthma Control Questionnaire (ACQ5)|Change in overall ACQ5. ACQ5 measures asthma control and a lower values shows a better asthma control, a higher value is worse. A decrease in the ACQ5 shows an improvement during the treatment period. Range of ACQ5 is 0-5, with 0 as the best value and 5 as the worst value. Further information at www.qoltech.co.uk.|Baseline e and 6 weeks|The Full Analysis Set (FAS) comprises all randomized patients regardless of whether they took IP or not and for whom data had been recorded in the CRF after randomization.||units on a scale||Standard Deviation|Mean
803123|NCT00989833|Secondary|Use of as Needed Medication|Mean number of as needed inhalations taken before exercise|6 weeks|The Full Analysis Set (FAS) comprises all randomized patients regardless of whether they took IP or not and for whom data had been recorded in the CRF after randomization.||number of inhalations per day||Standard Deviation|Mean
803124|NCT00989833|Secondary|Concentration of Exhaled Nitric Oxide||6 weeks|The Full Analysis Set (FAS) comprises all randomized patients regardless of whether they took IP or not and for whom data had been recorded in the CRF after randomization.||ppb||Standard Deviation|Mean
803125|NCT00989833|Secondary|Bronchial Responsiveness to Mannitol|Change in cumulative Mannitol dose in mg in patients with a positive mannitol provocation test at baseline (PD15)|Baseline and 6 weeks|The Full Analysis Set (FAS) comprises all randomized patients regardless of whether they took IP or not and for whom data had been recorded in the CRF after randomization.||mg||Standard Deviation|Mean
803126|NCT00989833|Secondary|Percent Change in Maximum Post-exercise FEV1 Fall After 3 Weeks|FEV1|Baseline and 3 weeks|The Full Analysis Set (FAS) comprises all randomized patients regardless of whether they took IP or not and for whom data had been recorded in the CRF after randomization.||Percent change||Standard Deviation|Mean
803127|NCT00989833|Primary|Percent Change in Maximum Post-exercise Forced Expiratory Volume in One Second (FEV1) Fall After 6 Weeks|FEV1|Baseline and Visit 6|The Full Analysis Set (FAS) comprises all randomized patients regardless of whether they took IP or not and for whom data had been recorded in the CRF after randomization.||Percent change||Standard Deviation|Mean
803128|NCT00989911|Primary|Pulmonary Blood Flow as Determined by MRI Velocity Encoding at 3-6 Months|Magnetic resonance imaging-derived aortic flow|3-6 months|||L/min||Standard Deviation|Mean
803129|NCT00989950|Primary|Sleep Latency|Measure by daily subject sleep diary|9 weeks|All 26 subjects wore the patches for 9, 10, 11 and 12 hour wears. Results are based upon impact of patch wear time on parameter||minutes||95% Confidence Interval|Mean
803130|NCT00989989|Secondary|Patient Outcome Measure Euro Quality of Life Questionnaire (EQ-5D)|"The Euro Quality of Life Questionnaire (EQ-5D) standardized instrument was utilized to measure health outcomes related to mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Participants self-rate their health on a visual, vertical analogue scale from 0 to 100 where the endpoints are labeled Best imaginable health state (100) and worst imaginable health state (0)."|12 months|The Full Analysis Set consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment) and had at least one post-baseline assessment for Best-Corrected Visual Acuity.||units on a scale||Standard Deviation|Mean
806870|NCT01017237|Primary|Amnesia: Lack of Picture Recall Shown 15 Minutes Into Surgery|Lack of recall of picture shown at this time indicates presence of amnesia|Day of Surgery prior to discharge|per protocol||percentage of patients|||Number
803131|NCT00989989|Secondary|Best-Corrected Visual Acuity (BCVA) Mean Change From Baseline at Month 12|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. A positive change from baseline of BCVA indicates improvement.|12 months|The Full Analysis Set consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment)and had at least one post-baseline assessment for Best-Corrected Visual Acuity.||Letters||Standard Deviation|Mean
803132|NCT00989989|Secondary|Percent of Participants Who Lost >= 15 Letters at Month 12 Compared to Baseline|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. A loss of 15 or more BCVA letters from baseline indicates worsening.|12 months|The Full Analysis Set consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment)and had at least one post-baseline assessment for Best-Corrected Visual Acuity.||Percentage of participants|||Number
803133|NCT00989989|Secondary|Percent of Participants Who Gained >= 15 Letters at Month 12 Compared to Baseline|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. A gain of 15 or more BCVA letters from baseline indicates improvement. A BCVA of 84 letters or more at Month 12 indicates improvement.|12 months|The Full Analysis Set consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment)and had at least one post-baseline assessment for Best-Corrected Visual Acuity.||Percentage of participants|||Number
803134|NCT00989989|Secondary|Percent of Participants Who Lost >= 10 Letters at Month 12 Compared to Baseline|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. A loss of 10 or more BCVA letters from baseline indicates worsening.|12 months|The Full Analysis Set consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment)and had at least one post-baseline assessment for Best-Corrected Visual Acuity.||Percentage of participants|||Number
803135|NCT00989989|Secondary|Percent of Participants Who Gained >= 10 Letters at Month 12 Compared to Baseline|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. A gain of 10 or more BCVA letters from baseline indicates improvement. A BCVA of 84 letters or more at Month 12 indicates improvement.|12 months|The Full Analysis Set consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment)and had at least one post-baseline assessment for Best-Corrected Visual Acuity.||Percentage of participants|||Number
803136|NCT00989989|Secondary|Percent of Participants With Visual Acuity Above 73 Letters at Month 12|Best Corrected Visual Acuity (BCVA) was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart at baseline and month 12 while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. BCVA above 73 letters at month 12 indicates a positive outcome.|12 months|The Full Analysis Set consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment)and had at least one post-baseline assessment for Best-Corrected Visual Acuity.||percentage of participants|||Number
803137|NCT00989989|Secondary|Percent of Participants With Anatomical Changes in Sub-retinal Fluid at End of Study Compared to Baseline|Presence or absence of sub-retinal fluid in any of the 6 sections of the study eye was measured using Optical Coherence Tomography (OCT). A complete resolution or decrease from baseline of sub-retinal fluid indicates improvement.|Up to 12 months|The Full Analysis Set consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment) and had sub-retinal fluid in any of the 6 sections of the study eye at baseline. Not applicable means there was no sub-retinal fluid at baseline.||percentage of participants|||Number
803138|NCT00989989|Secondary|Percent of Participants With Anatomical Changes in Intra-retinal Cysts at End of Study Compared to Baseline|Presence or absence of intra-retinal cysts in any of the 6 sections of the study eye was measured using Optical Coherence Tomography (OCT). A complete resolution or decrease from baseline of intra-retinal cysts indicates improvement.|Up to 12 months|The Full Analysis Set consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment) and had intra-retinal cysts in any of the 6 sections of the study eye at baseline - not applicable means there was no intra-retinal cyst at baseline.||percentage of participants|||Number
803139|NCT00989989|Secondary|Change From Baseline on Central Retinal Subfield Thickness (CRST) at Month 12|Central Retinal Subfield Thickness (CRST) was measured using Optical Coherence Tomography (OCT) in micrometers. A negative change from baseline of CRST indicates improvement.|12 months|The Full Analysis Set consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment) and had Central Retinal Subfield Thickness value with signal strength ≥ 5 for Carl Zeiss Optical Coherence Tomography 3 system.||micrometers||Standard Deviation|Mean
803140|NCT00989989|Primary|Average Change From Baseline of Best-Corrected Visual Acuity (BCVA) Over 12 Months (From Month 1 to Month 12 Compared to Baseline)|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. A positive average change from baseline of BCVA indicates improvement.|12 months|The Full Analysis Set (FAS) consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment) and had at least one post-baseline assessment for Best-Corrected Visual Acuity.||Letters||Standard Deviation|Mean
805726|NCT01005719|Secondary|Percentage of Time Intragastric pH >3.5 Over 24-hour Period on Day 7||Treatment dose to 24-hours post-dose on Day 7|Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.||Percentage of Time||Full Range|Median
803141|NCT00990093|Primary|Discomfort Measured on a VAS Scale 0 Being no Discomfort, 10 Being Worst Imaginable Discomfort.|"Participants were to test the catheter by self-catheterising a minimum of 4 catheters each day for 14 days.
At the end of each study period participants were asked to indicate how they would rate the discomfort experienced during the catheterisation procedures. Discomfort was measured by the participants own rating of discomfort on a VAS scale from 0 (no discomfort) to 10 (worst imaginable discomfort)"|14 days|Six participants discontinued the study in the first test period, i.e. before visit 2 at which the first catheter evaluation was to be given. The primary outcome was the catheter evaluation on discomfort, and these six participants did not contribute to the ITT analysis of the primary outcome.||units on a scale||Standard Deviation|Mean
803142|NCT00990106|Secondary|Alcohol Use Disorders Identification Test – Consumption (AUDIT-C)||Baseline, Weeks 7, 11 and 15||||||
803143|NCT00990106|Secondary|Penn Alcohol Craving Scale (PACS)||Baseline, Weeks 7, 11 and 15||||||
803144|NCT00990106|Secondary|SF-12V||Baseline, Weeks 7, 11 and 15||||||
803145|NCT00990106|Secondary|Quality Of Life Inventory (QOLI)||Baseline, Weeks 7, 11 and 15||||||
803146|NCT00990106|Secondary|Patient Health Questionnaire-9 (PHQ-9)||Baseline, Weeks 7, 11 and 15||||||
803147|NCT00990106|Secondary|Hamilton Depression Scale (HAM-D)||Baseline, Weeks 7, 11 and 15||||||
803148|NCT00990106|Secondary|CAPS Symptom Clusters (Reexperiencing/Intrusions, Numbing/Avoidance, and Hyperarousal)||Baseline, Weeks 7, 11 and 15||||||
803149|NCT00990106|Secondary|Clinician-Administered PTSD Scale (CAPS) Total Score||Baseline, Weeks 7, 11 and 15||||||
803150|NCT00990106|Primary|Clinical Global Impression of Change (CGIC)|The Clinical Global Impression of Change is a 7-point scale that rates global change compared to baseline (1=markedly improved, 2=moderately improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=moderately worse, 7=markedly worse). The CGIC is used to determine the impact of treat effects on meaningful and distinct change in overall sense of well-being and functioning. This outcome measures the proportion of responders who were rated markedly or moderately improved at Week 15 compared to Baseline.|Change from Baseline to Week 15|Of the 67 subjects randomized, 46 completed the full 15 weeks (23 per group). The outcome data reports only those 46 participants who completed the full 15 weeks.||Percentage of responders||95% Confidence Interval|Number
803151|NCT00990106|Primary|Change in Pittsburgh Sleep Quality Index (PSQI)|Pittsburgh Sleep Quality Index is a self-report questionnaire assessing sleep quality and disturbances over a 1-month time interval. A global score is obtained by summing the seven component subscales (total score range: 0-21). A score of 5 or less indicates good sleep quality. A score of more than 5 indicates poor sleep quality. Change is measured from Baseline to Week 15.|Baseline to Week 15|||Scores on a Scale||Standard Error|Mean
803152|NCT00990106|Primary|Change in Clinician Administered PTSD Scale for DSM-IV (CAPS) Recurrent Distressing Dreams Item|"Item B-2 recurrent distressing dreams of the event is a single item from the Clinician Administered PTSD Scale. The rating consists of two parts: Frequency and Intensity. Symptom frequency rated 0 to 4. Symptom intensity rated 0 to 4. Frequency plus Intensity ratings equal the total score. A higher score is worse; a lower score is better. This outcome measure evaluates the change in score from Baseline to Week 15."|Baseline to Week 15|Of the 67 subjects randomized, 46 completed the full 15 weeks (23 per group). The outcome data reports only those 46 participants who completed the full 15 weeks.||Scores on a Scale||Standard Error|Mean
803153|NCT00990184|Secondary|Glucose Disappearance Rate|Rate of fall of glucose in the blood|Baseline and 8 weeks|||percentage of glucose/min||Standard Error|Mean
803154|NCT00990184|Secondary|Insulin Sensitivity|"Tissue response to circulating insulin in the blood. Insulin sensitivity is measured using a mathematical model that quantifies the fractional rate of change in glucose concentrations per unit of insulin. Low values are insulin resistant and high values are insulin sensitive. *Please note: the -1 in the Unit of Measure should be a superscripted value."|Baseline and 8 weeks|||min-1 per pmol/L||Standard Error|Mean
803155|NCT00990184|Primary|Acute Insulin Response (AIRg) to Intravenous Glucose|Increase in insulin following glucose injection. AIRg is measured as the magnitude of the insulin response to an intravenous glucose injection calculated over the 10 minutes following glucose administration.|Baseline and 8 weeks|Subjects who completed the study||pmol/1*min||Inter-Quartile Range|Median
803156|NCT00990340|Secondary|Subject-reported Overall Satisfaction Following the End of Each Period of the Study.|The difference in subject-reported overall satisfaction between the two injection methods as recorded on a 5-point scale following the end of each period of the study. The overall satisfaction was to be rated by the subject on a 5-point scale as 1 (Really Unhappy) to 5 (Really Happy), a higher score denoting greater satisfaction. Overall satisfaction is obtained only once at the end of each period; Period 1 Tjet group was added to Period 2 Tjet group and Period 1 syringe group was added to Period 2 syringe group; no averaging was necessary.|28 Days; end of Period 1(14 days) and end of Period 2 (14 days)|Of the 52 subjects enrolled, 10 were unevaluable as follows: 4 discontinuations (2 adverse events, 1 lost to follow up, 1 inconsistent participation) 3 non-compliant dosing or diary use, 3 protocol violations ( 2 received devices out of randomized sequence, 1 interruption of injection due to device malfunction.||Scores on a scale||Standard Deviation|Least Squares Mean
803157|NCT00990340|Secondary|Subject or Caregiver Reported Perception of Ease of Administration as Recorded Weekly on a 5-point Scale.|The difference in subject-reported overall satisfaction between the two injection methods as recorded on a 5-point scale following the end of each period of the study. The overall satisfaction was to be rated by the subject on a 5-point scale as 1 (Really Unhappy) to 5 (Really Happy), a higher score denoting greater satisfaction. Overall satisfaction is obtained only once at the end of each period; Period 1 Tjet group was added to Period 2 Tjet group and Period 1 syringe group was added to Period 2 syringe group; no averaging was necessary.|28 Days; end of Period 1(14 days) and end of Period 2 (14 days)|Of the 52 subjects enrolled, 10 were unevaluable as follows: 4 discontinuations (2 adverse events, 1 lost to follow up, 1 inconsistent participation) 3 non-compliant dosing or diary use, 3 protocol violations ( 2 received devices out of randomized sequence, 1 interruption of injection due to device malfunction.||Scores on a scale||Standard Deviation|Least Squares Mean
803239|NCT00982280|Secondary|Clinical Global Impression of Change|In the Clinical Global Impression of Change (CGIC) the clinician indicates the perceived change over the treatment period. The clinician is requested to choose one of seven categories. Scores range from very much improved to very much worse.|Baseline; End of Week 6 (6 Weeks)|Intention to treat (ITT).||participants|||Number
803158|NCT00990340|Secondary|Subject or Caregiver Reported Perception of Ease of Preparation as Recorded Weekly on a 5-point Scale.|The difference in mean subject-reported injection anxiety between the two injection methods as recorded on a 5 point scale immediately before administration, which scale consisted of a row of five faces with values from 1(most positive)to 5(most negative or greater anxiety.) The score is an average of the Period 1 (Days 1-14) and Period 2 (Days 15-28) assessments; like arms were combined and then averaged. There were 3 visits: Visit 1 (Begin Period 1) Screening and Randomized assignment, Visit 2 (first day of Period 2) Cross over to other assignment, Visit 3 End of Study.|2 weeks|Of the 52 subjects enrolled, 10 were unevaluable as follows: 4 discontinuations (2 adverse events, 1 lost to follow up, 1 inconsistent participation) 3 non-compliant dosing or diary use, 3 protocol violations ( 2 received devices out of randomized sequence, 1 interruption of injection due to device malfunction.||Scores on a scale||Standard Deviation|Least Squares Mean
803159|NCT00990340|Secondary|Subject-reported Injection Pain Immediately Following Administration.|The difference in mean subject-reported injection anxiety between the two injection methods as recorded on a 5 point scale immediately before administration, which scale consisted of a row of five faces with values from 1(most positive)to 5(most negative or greater anxiety.) The score is an average of the Period 1 (Days 1-14) and Period 2 (Days 15-28) assessments; like groups were combined and then averaged. There were 3 visits: Visit 1 (Begin Period 1) Screening and Randomized assignment, Visit 2 (first day of Period 2) Cross over to other assignment, Visit 3 End of Study.|28 days; Period 1: 14 days, Period 2: 14 days|Of the 52 subjects enrolled, 10 were unevaluable as follows: 4 discontinuations (2 adverse events, 1 lost to follow up, 1 inconsistent participation) 3 non-compliant dosing or diary use, 3 protocol violations ( 2 received devices out of randomized sequence, 1 interruption of injection due to device malfunction.||Scores on a scale||Standard Deviation|Least Squares Mean
803160|NCT00990340|Primary|Subject-reported Injection Anxiety Immediately Before Administration|The difference in mean subject-reported injection anxiety between the two injection methods as recorded on a 5 point scale immediately before administration, which scale consisted of a row of five faces with values from 1(most positive)to 5(most negative or greater anxiety.) The score is an average of the Period 1 (Days 1-14) and Period 2 (Days 15-28) assessments; like groups were combined and then averaged. There were 3 visits: Visit 1 (Begin Period 1) Screening and Randomized assignment, Visit 2 (first day of Period 2) Cross over to other assignment, Visit 3 End of Study.|28 days; Period 1: 14 days, Period 2: 14 days|Of the 52 subjects enrolled, 10 were unevaluable as follows: 4 discontinuations (2 adverse events, 1 lost to follow up, 1 inconsistent participation) 3 non-compliant dosing or diary use, 3 protocol violations ( 2 received devices out of randomized sequence, 1 interruption of injection due to device malfunction.||Scores on a scale||Standard Deviation|Mean
803161|NCT00990509|Primary|Mean Intracerebral Hemorrhage (ICH) Volume|11 of 14 participants received a Day 5 MRI. Mean ICH volume based on 11 participants is presented.|Day 5 MRI|||cc||Standard Deviation|Mean
803162|NCT00990509|Primary|Assessment of Safety of Albumin Administration in Primary ICH|Serious adverse events. Specific safety outcomes assessed: frank pulmonary edema as visualized on chest X-Ray, congestive heart failure, neurological deterioration (4-point worsening on NIHSS), death|Through Day 90 following enrollment|||events|||Number
803163|NCT00990509|Primary|Mean Hyperintense Acute injuRy Marker (HARM)|Hyperintense Acute injuRy Marker (HARM) characterizes the frequency and severity of blood brain barrier disruption. Mean HARM is assessed on the post-contrast study using a previously developed 5 point scale (0 to 5).). A score of 0 indicates no HARM, whereas a score of 5 indicates diffuse and generalized HARM. 11 of 14 participants received a Day 5 MRI. HARM reads could only be performed on 4 of the 7 placebo subjects due to insufficient sequences or presence of subarachnoid blood. Mean HARM score is presented.|Day 5 MRI|||points|||Number
803164|NCT00990561|Secondary|Maintenance of Psoriasis Improvement With Lac-Hydrin Lotion After Discontinuation of Steroid Therapy||6 weeks||||||
803165|NCT00990561|Primary|Change in Modified Psoriasis Area Severity Index (PASI) Score|PASI is a scale that measures psoriasis severity based on erythema, induration, scaling, and body surface area covered. It ranges from 0 (no disease) to 72 (most extensive).|2 weeks|This was a pilot study and the number was based on the available budget to perform the study.||units on a scale||Full Range|Mean
803166|NCT00990652|Secondary|Overall Survival Rate at 6 Months|The rate of overall survival at 6 months (regardless of disease progression) was calculated.|After 6 months on study|The 6-month overall survival rate was based on a median of 168 days of follow-up.||percentage of participants|||Number
803167|NCT00990652|Secondary|Overall Survival (in Days)||Days 1, 4, 8 pre-surgery, once per cycle (every 4 weeks) while on treatment post-surgery, and then every 3 months up to 2 years during follow-up|||days||95% Confidence Interval|Median
803168|NCT00990652|Other Pre-specified|Pharmacokinetics of Bortezomib in Tumor Tissue Taken at the Time of Surgery.||Tissue sample taken at the time of surgery for all patients.||||||
803169|NCT00990652|Other Pre-specified|Change in MGMT Methylation Status as Well as Other Methylation Patterns in Plasma|To determine MGMT methylation status as well as other methylation patterns in plasma|Blood samples drawn on days 1, 4, and 8 pre-surgery, and then prior to cycle 1 and every 2 cycles thereafter||||||
803170|NCT00990652|Secondary|Number of Grade 1, 2, 3, 4, and 5 Adverse Events Observed During Study Treatment (Defined by CTCAE v 3.0)|"Adverse events (AEs) were graded according to the National Cancer Institute's Common Toxicity Criteria for Adverse Events (CTCAE) version 3.0. In general, AEs are graded according to the following:
Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE"|Days 1, 4, 8 pre-surgery, and then at the start of every cycle (approximately every 4 weeks) post-surgery while on treatment|||adverse events|||Number
803171|NCT00990652|Secondary|Number of Participants Achieving a Response to Treatment (Either Complete or Partial Response) as Defined by MacDonald Criteria|"This measure was assessed only in patients who had residual tumor post-operatively. Per MacDonald Criteria:
Complete Response requires complete disappearance of all measurable & evaluable disease, no new lesions, no evidence of non-evaluable disease, and only minimal or no use of steroids.
Partial Response is defined as >= 50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable lesions, no progression of evaluable disease, and no new lesions. Responders must be on the same or decreasing doses of steroid.
Response was assessed by imaging (MRI or CT with contrast)."|Day of treatment post-surgery and then approximately every 8 weeks thereafter until off treatment|Only those participants who had residual tumor remaining after surgical resection were evaluated for this outcome.||participants|||Number
803172|NCT00990652|Primary|Number of Patients Surviving Without Disease Progression After 6 Months|"Patients will be monitored from date of first treatment to the date of first observation of progressive disease, non-reversible neurologic progression or increasing steroid requirements, death due to any cause, or early discontinuation of treatment. Progression-free survival will be defined as the absence of any of the above after 6 months.
Progression (defined by MacDonald Criteria) is a 25% increase in the sum of products of all measurable lesions over smallest sum observed compared to baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to the cancer)."|From date of first treatment until disease progression, death, or early discontinuation of treatment (up to 24 months)|||participants|||Number
803173|NCT00990652|Other Pre-specified|Correlation of Expression of NFKBIA Gene With Response to Therapy and Survival.|The effects of bortezomib on the endogenous modulators of NF-Kappa B pathways, especially the NFKBIA gene (nuclear factor of kappa light polypeptide gene enhancer in B-cells inhibitor, alpha) were assessed using novel assay technology; expression of NFKBIA was then correlated with response to therapy and patient survival.|Tissue samples for analysis were obtained on the day of surgery for all patients||||||
803174|NCT00990704|Secondary|Number of Occurrences of iPTH Control, Defined as Within the Target Range of 60-180 pg/mL of iPTH||Over the 12-week treatment period|||Occurrences per participant||Standard Deviation|Mean
803175|NCT00990704|Secondary|Number of Occurrences of iPTH Control, Defined as >=50% Reduction in iPTH From Baseline||Over the 12-week treatment period|||Occurrences per participant||Standard Deviation|Mean
803176|NCT00990704|Secondary|Percentage of Participants With iPTH Within the Target Range of 60-180 pg/mL Based on the Average iPTH Obtained in the Last 3 Weeks of the Study and Without Hypercalcemia Anytime During Treatment|Hypercalcemia was defined as at least 1 corrected calcium > 11.5 mg/dL or at least 2 consecutive corrected calcium >= 11.0 mg/dL.|Baseline and the last 3 weeks (Weeks 11, 12, and 13) for iPTH and anytime during the 12-week treatment period for hypercalcemia|||Percentage of participants|||Number
803177|NCT00990704|Secondary|Percentage of Participants With a >= 50% Reduction in iPTH From Baseline to the Average iPTH Obtained in the Last 3 Weeks and Without Hypercalcemia During Treatment|Hypercalcemia was defined as at least 1 corrected calcium > 11.5 mg/dL or at least 2 consecutive corrected calcium >= 11.0 mg/dL.|Baseline and the last 3 weeks (Weeks 11, 12, and 13) for iPTH and anytime during the 12-week treatment period for hypercalcemia|||Percentage of participants|||Number
803178|NCT00990704|Secondary|Mean Change in iPTH From Baseline to the Average iPTH Obtained in the Last 3 Weeks||Baseline and the last 3 weeks (Weeks 11, 12, and 13)|||pg/mL||Standard Deviation|Mean
803179|NCT00990704|Secondary|Mean iPTH at Each Visit||Screening (up to 2 weeks before Baseline) to Week 13|||pg/mL||Standard Deviation|Mean
803180|NCT00990704|Secondary|The Percentage of Participants With iPTH Within Target Range of 60-180 pg/mL, Based on the Average iPTH Obtained in the Last 3 Weeks||During the last 3 weeks (Weeks 11, 12, and 13)|||Percentage of participants|||Number
803181|NCT00990704|Primary|The Percentage of Participants With a >=50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline Compared to the Average iPTH Obtained in the Last 3 Weeks.||Baseline and the last 3 weeks (Weeks 11, 12, and 13)|All subjects who received at least 1 dose of study drug and who had at least 1 iPTH measurement while on treatment.||Percentage of participants|||Number
803182|NCT00990769|Secondary|Pain Score: Faces, Legs, Activity, Cry, and Consolability (FLACC)|Pain was assessed with the Faces, Legs, Activity, Cry, and Consolability (FLACC) scale. The FLACC scale is an observational measure of child behavior in response to postoperative pain. Five subscales are rated from 0-2 on severity: facial expression, leg position and motion, psychomotor agitation, crying, and inconsolability. Subscale scores are summed to compute a total score ranging from 0-10, with 10 representing the most severe pain. In the post-operative setting, the FLACC scale is validated for cognitively intact children up to age 7 years, and was used for all children in the study.|Within 30 minutes of arrival in recovery room|All patients were analyzed.||units on a scale||Standard Deviation|Mean
803183|NCT00990769|Secondary|Time to Emergence From Anesthesia|The time from cessation of anesthesia delivery (Sevoflurane turned off) to extubation.|After the completion of surgery|All patients were analyzed||minutes||Standard Deviation|Mean
803184|NCT00990769|Primary|Peak Pediatric Assessment of Emergence Delirium (PAED) Score Within the First 30 Minutes of Reaching the Recovery Room (Post-Anesthesia Care Unit)|The PAED scale is a validated observational measure of five aspects of child behavior on emergence from anesthesia (caregiver eye contact, purposeful movement, evidence of awareness of surroundings, restlessness, and inconsolability). Ratings are summed to arrive at a total score ranging from 0 – 20, with higher scores indicating greater severity of emergence agitation.|Within 30 minutes of arrival in recovery room|All patients in each group were analyzed.||units on a scale||Standard Deviation|Mean
803185|NCT00990782|Secondary|Number of Participants With Capsule-identified Esophageal Injury Who Report Symptoms Post-RFA||14 Days|||Participants|||Count of Participants
803186|NCT00990782|Primary|Number of Participants With Esophageal Lesions Identified Using Capsule Endoscopy||14 days|||Participants|||Count of Participants
803187|NCT00990821|Primary|Area Under the Plasma-Time Curve (AUC[0 to Infinity]) for Aprepitant and MK-0517 for Study Part V|AUC (0-inf) is the area under the plasma concentration-time curve from time zero extrapolated to infinite time. The AUC(0-inf) bioequivalence was evaluated for single doses of 100 and 115 mg MK-0517 PS80, IV and that of an oral 125-mg capsule of aprepitant. Period I to IV populations are not included in the outcome analysis because those were formulation and dose-finding/dose confirmation arms.|Up to 72 Hours Post Dose|All participants in Part V who had at least one period of AUC data were included in the evaluation of pharmacokinetics. Participants without sufficient concentration data for an AUC calculation included: 6 participants in the Aprepitant (125 mg) , 8 participants in the MK-0517 (100 mg) group, and 5 participants in the MK-0517 (115 mg) group.||ng*hr/mL||Standard Deviation|Least Squares Mean
803188|NCT00982007|Primary|Mean Increase From Baseline to the Highest Observed Hemoglobin Value Between Baseline and Day 35 or Time of Intervention for Patients Taking FCM as Compared to That for Patients Taking Ferrous Sulfate.||Day 35|Modified Intent-to-Treat Population: Subjects who have received at least 1 dose of randomized study medication and had at least 1 post-baseline hemoglobin assessment||g/dL||Standard Deviation|Mean
812463|NCT01070784|Primary|Clinical Laboratory Test: Clinical Chemistry- S-Alkaline Phosphatase (ALP)|Change from baseline|Baseline and 52 week after|||U/L||Standard Deviation|Mean
803193|NCT00982020|Secondary|Mean Change From Baseline to 52 Weeks in Adolescent Structured Young Mania Rating Scale (YMRS) for Participants With Bipolar I Disorder|The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 (symptom not present) to 60 (symptom extremely severe).|Baseline, 52 weeks|All randomized participants with bipolar I disorder, who received at least one dose of study drug. Mixed model repeated measures (MMRM) methodology.||units on a scale||Standard Error|Least Squares Mean
803194|NCT00982020|Secondary|Time to Event for 7%, 15%, and 25% Weight Gain for All Participants|Kaplan-Meier methodology used to estimate time to event. Participants who never reached the target weight gain contributed to the set of patients at risk up to the point at which they discontinued from the study and were then censored (i.e., removed from the risk set).|Baseline up to 52 weeks|"65 participants (32%; 34% in Standard Group [SG], 30% in Intense Group [IG]) did not meet 7% weight gain criterion [WGC] by the time they discontinued.
122 participants (60%; 58% in SG, 62% in IG) did not meet 15% WGC by the time they discontinued.
161 participants (79%; 76% in SG, 82% in IG) did not meet 25% WGC by the time they discontinued."||days||95% Confidence Interval|Median
803195|NCT00982020|Secondary|Mean Change From Baseline to Endpoint in Body Mass Index (BMI) for Participants With Duration of Treatment of at Least 6 Months||Baseline, 52 weeks|All randomized participants who received at least one dose of study drug and who had at least 6 months of data. Last observation carried forward (LOCF) methodology.||kg/m^2||Standard Error|Least Squares Mean
803196|NCT00982020|Primary|Mean Change From Baseline to 52 Weeks in Body Mass Index (BMI) for All Participants||Baseline, 52 weeks|All randomized participants who received at least one dose of study drug. Mixed model repeated measures (MMRM) methodology used.||kilograms per meter squared (kg/m^2)||Standard Error|Least Squares Mean
803197|NCT00982033|Primary|Exercise Treadmill Time|"Treadmill exercise time to exhaustion on the modified naughton protocol.
LS-mean is in effect, within-group means appropriately adjusted for the other effects in the model."|Baseline, 24 week visit|||seconds||Standard Deviation|Mean
803198|NCT00982111|Secondary|Percentage of Participants With EGFR Measured by IHC|EGFR IHC H-score = weighted sum of % 1+ cells, twice % 2+ cells, and three times % 3+ cells. IHC H-score criteria assesses participants with a low EGFR expression defined by a H-score cutoff value of < 200 and participants with a high EGFR expression defined by a H-score of cutoff value of >=200.|Baseline|Translational research population included all participants who: (1) received at least one dose of study drug; (2) had a valid non-missing result for EGFR H-Score; and (3) were enrolled for more than 2 cycles prior to the decision to terminate enrollment||percentage of participants|||Number
803199|NCT00982111|Secondary|Epidermal Growth Factor Hormone (EGFR) Protein Expression Measured by Immunohistochemistry (IHC)|EGFR IHC H-score = weighted sum of % 1+ cells, twice % 2+ cells, and three times % 3+ cells. IHC H-score criteria assesses participants with a low EGFR expression defined by a H-score cutoff value of < 200 and participants with a high EGFR expression defined by a H-score of cutoff value of >=200.|Baseline|Translational research population included all participants who: (1) received at least one dose of study drug; (2) had a valid non-missing result for EGFR H-Score; and (3) were enrolled for more than 2 cycles prior to the decision to terminate enrollment.||H-Score||Standard Deviation|Mean
803200|NCT00982111|Secondary|Mean Change From Baseline in PRO as Measured Using the Lung Cancer Symptom Scale (LCSS)|The LCSS consisted of 9 items: 6 items focused on lung cancer symptoms [loss of appetite, fatigue, cough, dyspnea (shortness of breath), hemoptysis (blood in sputum), and pain] and 3 items were global items (symptom distress, interference with activity level, and global quality of life). Participant responses to each item were measured using visual analogue scales (VAS) with 100-mm lines. A higher score for any item represented a higher level of symptoms/problems. Scores for each of the reported categories ranged from 0 (for best outcome) to 100 (for worst outcome). The Average Symptom Burden Index (ASBI) was the mean of the 6 symptom items of the LCSS, and the Total LCSS was the mean of all 9 LCSS items. ASBI and Total LCSS were not computed for a participant if he/she had 1 or more missing values for the 6 and 9 items, respectively.|Baseline, Cycle 6 (Cycle =3 Weeks)|All randomized participants who had evaluable baseline and postbaseline LCSS data.||millimeter (mm)||Standard Deviation|Mean
803201|NCT00982111|Secondary|Mean Change From Baseline in Patient Reported Outcomes (PRO) Using the European Quality of Life-5 Dimensions (EQ-5D)|The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a three level scale 1-3 (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension).|Baseline, Cycle 6 (Cycle = 3 weeks)|All randomized participants who had evaluable baseline and postbaseline EQ-5D data.||units on a scale||Standard Deviation|Mean
803202|NCT00982111|Secondary|Number of Participants With Serum Anti-Necitumumab Antibody Assessment (Immunogenicity)|A participant was considered to have an anti-Necitumumab antibody response if anti-drug antibodies (ADA) were confirmed positive. Treatment emergent antibodies were defined as any anti-Necitumumab antibody titer equal to or greater than 4-fold the participant's baseline titer.|Baseline to Study Completion (Up to 31.6 Months)|All randomized participants who received at least one dose of necitumumab and had evaluable antibody data.||participants|||Number
803203|NCT00982111|Secondary|Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab||Predose Day 1 of Cycle 2,3,4,5 and 6 Prior to Necitumumab Infusion, Up to 23 Weeks|Participants who were randomized to necitumumab and had evaluable PK data.||micrograms/milliliter (ug/ml)||Geometric Coefficient of Variation|Geometric Mean
803223|NCT00982228|Secondary|Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 52 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator.||Episodes/100 years of patient exposure|||Number
803204|NCT00982111|Secondary|Time to Treatment Failure (TTF)|TTF was defined as the time from study enrollment/randomization to the first observation of measured progressive disease, death from any cause, or early discontinuation of treatment or initiation of new anti-cancer therapies. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. Progressive Disease (PD) was defined as having at least a 20% increase in sum of longest diameter of target lesions. Time to treatment failure was censored at the date of the last follow-up visit for participants who did not discontinue early, who were still alive, and who have not progressed.|Randomization to Measured Progressive Disease, Death from Any Cause, Discontinuation of Treatment or Initiation of New Anticancer Therapy (Up to 30.4 Months)|All randomized participants. Censored participants: Necitumumab + Pemetrexed + Cisplatin = 10, Pemetrexed + Cisplatin = 13||Months||95% Confidence Interval|Median
803205|NCT00982111|Secondary|Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) (Objective Tumor Response Rate [ORR])|ORR is confirmed best overall tumor response of CR or PR. According to RECIST v1.0, CR was defined as the disappearance of all target and non-target lesions; PR defined as a >30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD. Percentage of participants was calculated as: (total number of participants with CR or PR from start of the treatment until disease progression or recurrence)/total number of participants treated) * 100.|Baseline to Measured Progressive Disease (Up to 30.4 Months)|All randomized participants.||percentage of participants||95% Confidence Interval|Number
803206|NCT00982111|Secondary|Progression-Free Survival (PFS)|PFS is defined as the time from randomization until the first radiographic documentation of measured progressive disease as defined by RECIST (Version 1.0), or death from any cause. Participants who die without a reported prior progression will be considered to have progressed on the day of their death. Participants who did not progress or were lost to follow-up were censored at the day of their last radiographic tumor assessment. If no baseline or postbaseline radiologic assessment was available, the participant was censored at the date of randomization. If death or PD occurs after two or more consecutive missing radiographic visits, censoring occurred at the date of the last radiographic visit prior to the missed visits.|Randomization to Measured Progressive Disease or Death from Any Cause (Up to 30.4 Months)|All randomized participants. Censored participants: Necitumumab + Pemetrexed + Cisplatin=84, Pemetrexed + Cisplatin=79||Months||95% Confidence Interval|Median
803207|NCT00982111|Primary|Overall Survival Time (OS)|OS is defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive. OS was estimated using the Kaplan-Meier method.|Randomization to Death from Any Cause (Up to 31.6 Months)|All randomized participants. Censored participants: Necitumumab + Pemetrexed + Cisplatin =79, Pemetrexed + Cisplatin=72||Months||95% Confidence Interval|Median
803208|NCT00982137|Primary|Number of Participants Reporting Solicited Local and Systemic Adverse Events Post Vaccination With ChimeriVax™-JE or STAMARIL® Alone or the Co-Administration of ChimeriVax™-JE and STAMARIL®, or Placebo|"Solicited Local Adverse Events: Injection Site Pain, Erythema, Swelling, Hemorrhage, Venipuncture site Hemorrhage. Solicited Systemic Adverse Events: Fatigue, Malaise, Pyrexia, Chills, Headache, Dizziness, Myalgia, Abdominal Pain, Diarrhea, Nausea, Pharyngolaryngeal Pain.
All solicited local reactions associated with ChimeriVax™-JE are presented in Group 1, those associated with STAMARIL® in Group 2, those associated with co-administered vaccines in Group 3, and those associated with diluent in Group 4. The solicited systemic adverse events are reported according to the participants' randomized study groups."|Day 0 up to Day 60 post-vaccination|Safety analyses were performed on data from all randomized subjects who received at least one dose of study medication: ChimeriVax JE, STAMARIL, or Diluent (Safety Population).||Participants|||Number
803209|NCT00982137|Primary|Number of Participants Who Seroconverted to Japanese Encephalitis 30 Days Post ChimeriVax™-JE Vaccination|Neutralising antibody titer against homologous JE, YF, and other relevant wild type JE strains was determined using a 50% serum dilution plaque reduction neutralisation test. Seroconversion at a later post vaccination timepoint was defined as the appearance of neutralising antibody titer when not present at Day 0, or at least a four-fold rise in neutralising antibody titer between the pre-injection Day 0 and post-vaccination samples.|Day 0 (Pre-vaccination) through Day 30 post-vaccination|Japanese encephalitis seroconversion was assessed in all participants who were flavivirus naive at Day 0 and who had no protocol violations that might have interfered with analysis of primary endpoints (Per Protocol Population).||Participants|||Number
803210|NCT00982137|Secondary|Geometric Mean Titers to Yellow Fever (Homologous Virus) Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL®, or Placebo|"Neutralising antibody titer against homologous yellow fever was determined using a 50% serum dilution plaque reduction neutralisation test.
Post vaccination 15 (30) Days Yellow Fever seroconversion is: Day 15 (30) for Group 1 (ChimeriVax™-JE then STAMARIL®) and Group 3 (Co-administration of ChimeriVax™-JE and STAMARIL, then Diluent); Day 45 (60) for Group 2 (STAMARIL® then ChimeriVax™-JE) and Group 4 (Diluent then Co-administration of ChimeriVax™-JE and STAMARIL)."|Day 0 through 6 months post-vaccination|GMTs were assessed in all participants who were flavivirus naive at Day 0 and who had no protocol violations that might have interfered with analysis of primary endpoints (Per-Protocol Population).||Titers||95% Confidence Interval|Geometric Mean
803211|NCT00982137|Secondary|Geometric Mean Titers (GMTs) to Japanese Encephalitis (Homologous Virus) Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL®, or Placebo Vaccination.|"Neutralising antibody titer against homologous Japanese encephalitis (JE) and other relevant wild type JE strains was determined using a 50% serum dilution plaque reduction neutralisation test.
Post-vaccination 15 (30) Days JE seroconversion is: Day 15 (30) for Group 1 (ChimeriVax™-JE then STAMARIL®) and Group 3 (Co-administration of ChimeriVax™-JE and STAMARIL, then Diluent); Day 45 (60) for Group 2 (STAMARIL® then ChimeriVax™-JE) and Group 4 (Diluent then Co-administration of ChimeriVax™-JE and STAMARIL)"|Day 0 through 6 months post-vaccination|GMTs were assessed in all participants who were flavivirus naive at Day 0 and who had no protocol violations that might have interfered with analysis of primary endpoints (Per-protocol Population).||Titers||95% Confidence Interval|Geometric Mean
804169|NCT00996892|Secondary|Cmax of Pictilisib on Cycle 1 Day 18 – Stage 1A All Cohorts||Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
803212|NCT00982137|Primary|Number of Participants With Yellow Fever Seroconversion Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL® or Placebo Vaccination.|"Neutralising antibody titer against yellow fever strains was determined using a 50% serum dilution plaque reduction neutralisation test. Seroconversion at a later post vaccination timepoint ws defined as the appearance of neutralising antibody titer when not present at Day 0, or at least a four-fold rise in neutralising antibody titre between the pre-injection Day 0 and later post vaccination samples.
The Day 30 post-JE seroconversion is: Day 30 for Group 1 (ChimeriVax™-JE then STAMARIL®) and Group 3 (Co-administration of ChimeriVax™-JE and STAMARIL, then Diluent); Day 60 for Group 2 (STAMARIL® then ChimeriVax™-JE) and Group 4 (Diluent then Co-administration of ChimeriVax™-JE and STAMARIL)."|Pre-vaccination (Day 0 or 30) and post-vaccination (Day 30 or 60)|Yellow fever seroconversion was assessed in all participants who were flavivirus naive at Day 0 and who had no protocol violations that might have interfered with analysis of primary endpoints (Per Protocol Population).||Participants|||Number
803213|NCT00982137|Primary|Number of Participants With Japanese Encephalitis Seroconversion Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL®, or Placebo Vaccination.|"Neutralising antibody titer against homologous Japanese encephalitis (JE), yellow fever (YF), and other relevant wild type JE strains were determined using a 50% serum dilution plaque reduction neutralisation test. Seroconversion post-vaccination was defined as the appearance of neutralising antibody titer when not present at Day 0, or at least a four-fold rise in neutralising antibody titer between the pre-vaccination (Day 0) and the post-vaccination samples.
The 30 Days post-JE seroconversion is: Day 30 for Group 1 (ChimeriVax™-JE then STAMARIL®) and Group 3 (Co-administration of ChimeriVax™-JE and STAMARIL, then Diluent); Day 60 for Group 2 (STAMARIL® then ChimeriVax™-JE) and Group 4 (Diluent then Co-administration of ChimeriVax™-JE and STAMARIL)."|Pre-vaccination (Day 0 or 30) and post-vaccination (Day 30 or 60)|Japanese encephalitis seroconversion was assessed in all participants who were flavivirus naive at Day 0 and who had no protocol violations that might have interfered with analysis of primary endpoints (Per-Protocol Population).||Participants|||Number
803214|NCT00982189|Secondary|Changes in Biomarkers|The biomarkers assessed in this study were soluble proteins measured in blood, or the plasma component of blood. The biomarkers measured represent inflammation and activation of the immune system in the body.|change from baseline to 4 months||||||
803215|NCT00982189|Secondary|Changes in Small Artery Elasticity|Small artery elasticity is a measure of vascular function, estimated through analysis of the blood pressure waveform. A sensor is placed on wrist over the radial pulse. The blood pressure waveform of the pulse is recorded and analyzed the elasticity, or compliance, of the small (and large) vasculature. Impaired artery elasticity, or increased stiffness, is an early sign of vascular disease that predicts risk for future cardiovascular events.|change from baseline to 4 months||||||
803216|NCT00982189|Secondary|Changes in Blood Lipids|Blood lipids include routine cholesterol measurements that are monitored in clinical practice. They are measured in blood after a blood draw is performed. The specific measurements include: a) total cholesterol, b) low-density lipoprotein cholesterol, c) high-density lipoprotein cholesterol, and d) triglycerides|change from baseline to 4 months||||||
803217|NCT00982189|Secondary|Changes in Blood Pressure|Blood pressure was assessed by standard clinical methods (i.e., the same way it is measured during a routine clinic visit)|change from baseline to 4 months||||||
803218|NCT00982189|Primary|Change From Baseline to Month 4 in the Framingham Risk Score (FRS)|The Framingham Risk Score is calculated by a published algorithm that predicts a patients risk of having a coronary heart disease event in the next 10 years. The measures that are considering in predicting this risk are: age, blood pressure, cholesterol (both total cholesterol and high-density lipoprotein cholesterol), smoking status, and use of medication to treat hypertension. This risk score can be estimated using an online calculator (http://hp2010.nhlbihin.net/atpiii/calculator.asp)|Change from baseline to 4 months|All participants had Framingham risk score (FRS) estimated at baseline and month 4. The change from baseline to month 4 was calculated as the outcome.||Percent probability of CHD event in 10yr||Inter-Quartile Range|Median
803219|NCT00982189|Primary|Number of Participants Who Took >90% of Their Doses (by Pill Count)|The number of pills missing from study medication bottles was counted by study nurses at the completion of the study. The proportion of pills taken divided by the number of days the participant was enrolled in the study was calculated, and multiplied by 100, to generate the '% of doses taken'|4 months|Number of participants who took >90% of their doses (by pill count)were studied. All participants who returned unused medications at end of the study were included for these analyses||participants|||Number
803220|NCT00982189|Primary|Number of Participants Who Stated (by Self-report) That They Had Side Effects|Participants were asked at each visit if they had any side effects to study medication. They provided a yes or no answer, and if yes they specified what the side effect was.|4 months|Number of participants who stated (by self-report) that they had side effects||participants|||Number
803221|NCT00982228|Secondary|Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 52|Mean of 9-point self-measured plasma glucose profile (SMPG) after 52 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast.|Week 52|The FAS included all randomised subjects and missing data was imputed using LOCF. For 7 subjects all 9-point SMPG values were missing.||mmol/L||Standard Deviation|Mean
803222|NCT00982228|Secondary|Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occuring between 00:01 and 05:59 a.m.|Week 0 to Week 52 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator.||Episodes/100 years of patient exposure|||Number
803237|NCT00982280|Secondary|Patient Global Impression of Change|In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant is requested to choose one of seven categories. Scores range from very much improved to very much worse.|Baseline; End of Week 6 (6 Weeks)|Intention to treat (ITT).||participants|||Number
803224|NCT00982228|Secondary|Extension Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 104 of Treatment|Mean of 9-point self-measured plasma glucose profile (SMPG) after 104 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast.|Treatment week 104|The FAS included all randomised subjects in the main trial including subjects carried through to the extension trial and missing data was imputed using LOCF. For 12 subjects all 9-point SMPG values were missing.||mmol/L||Standard Deviation|Mean
803225|NCT00982228|Secondary|Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment|Change from baseline in HbA1c after 104 weeks of treatment|Week 0, Week 104|The FAS included all randomised subjects in the main trial including subjects carried through to the extension trial and missing data was imputed using LOCF.||percentage of glycosylated haemoglobin||Standard Deviation|Mean
803226|NCT00982228|Primary|Extension Trial (Primary Endpoint): Cross-reacting Antibodies to Human Insulin|The unit for measuring antibody levels is amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture (%B/T). Samples were taken before 1st dosing and after a 1-week wash-out period.|Week 0, Week 106|The SAS included all subjects who received at least one dose of the investigational product or its comparator in the main trial including subjects carried through to the extension trial.||%B/T||Standard Deviation|Mean
803227|NCT00982228|Secondary|Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occuring between 00:01 and 05:59 a.m.|Week 0 to Week 104 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator in the main trial including subjects carried through to the extension trial.||Episodes/100 years of patient exposure|||Number
803228|NCT00982228|Primary|Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 104 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator in the main trial including subjects carried through to the extension trial.||Episodes/100 years of patient exposure|||Number
803229|NCT00982228|Primary|Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)|Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.|Week 0 to Week 104 + 7 days follow up|Safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or its comparator in the main trial including subjects carried through to the extension trial.||Events/100 years of patient exposure|||Number
803230|NCT00982228|Primary|Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment|Change from baseline in HbA1c after 52 weeks of treatment|Week 0, Week 52|The full analysis set (FAS) included all randomised subjects and missing data was imputed using LOCF (last observation carried forward).||percentage of glycosylated haemoglobin||Standard Deviation|Mean
803231|NCT00982280|Secondary|Mean Equipotency Ratio of Tapentadol Compared to Oxycodone|Tapentadol was compared to Oxycodone with Oxycodone set to 1. The average total daily dose of Tapentadol at which a pain score equivalent or below to the pain score at the end of observation period under Oxycodone was reached was documented as the equipotent or equianalgesic dose to the total daily dose of the previously used Oxycodone.|Baseline; End of Week 6 (6 Weeks)|Intention to treat (ITT). 6 participants with previous oxycodone treatment.||Ratio|||Number
803232|NCT00982280|Secondary|Mean Equipotency Ratio of Tapentadol Compared to Buprenorphine|Tapentadol was compared to Transdermal Buprenorphine with Buprenorphine set to 1. The average total daily dose of Tapentadol at which a pain score equivalent or below to the pain score at the end of observation period under Transdermal Buprenorphine was reached was documented as the equipotent or equianalgesic dose to the total daily dose of the previously used Transdermal Buprenorphine.|Baseline; End of Week 6 (6 Weeks)|Intention to treat (ITT). 48 participants with previous transdermal buprenorphine treatment.||Ratio|||Number
803233|NCT00982280|Secondary|Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol.|Participants were requested to rate their tapentadol (new) analgesic medication on a 5-point scale. The medication was rated as excellent, very good, good, fair and poor.|After 12 weeks|Intention to treat (ITT).||participants|||Number
803234|NCT00982280|Secondary|Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol.|Participants were requested to rate their tapentadol (new) analgesic medication on a 5-point scale. The medication was rated as excellent, very good, good, fair and poor.|After 6 weeks|Intention to treat (ITT).||participants|||Number
803235|NCT00982280|Secondary|Participant's Satisfaction With Previous Analgesic Treatment.|Participants were requested to rate their previous analgesic medication on a 5-point scale. Previous medication was rated as excellent, very good, good, fair and poor.|Baseline|Intention to treat (ITT).||participants|||Number
803236|NCT00982280|Secondary|Patient Global Impression of Change|In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant is requested to choose one of seven categories. Scores range from very much improved to very much worse.|Baseline; End of Week 12 (12 Weeks)|Intention to treat (ITT).||participants|||Number
812464|NCT01070784|Primary|Clinical Laboratory Test: Clinical Chemistry- S-Aspartate Aminotransferase|Change from baseline|Baseline and 52 week after|||U/L||Standard Deviation|Mean
803240|NCT00982280|Secondary|Change in Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS)|EuroQoL-5D Health State Visual Analog Scale (VAS) is a participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. The values indicated represent the change from the baseline, a positive value indicates an improvement.|12 Weeks|Intention to treat (ITT)||Units on a scale||Standard Deviation|Mean
803241|NCT00982280|Secondary|Change in Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS)|EuroQoL-5D Health State Visual Analog Scale (VAS) is a participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. The values indicated represent the change from the baseline, a positive value indicates an improvement.|6 Weeks|Intention to treat (ITT)||Units on a scale||Standard Deviation|Mean
803242|NCT00982280|Secondary|EuroQol-5 (EQ-5D) Health Status Index Outcome Over Time|"The participant scored the EuroQol-5. This is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating full health and 0 representing dead. The positive values indicate that during the study the health status improved."|12 weeks|Intention to treat (ITT).||Units on a scale||Standard Deviation|Median
803243|NCT00982280|Secondary|EuroQol-5 (EQ-5D) Health Status Index Outcome Over Time|"The participant scored the EuroQol-5. This is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating full health and 0 representing dead. The positive values indicate that during the study the health status improved."|6 weeks|Intention to treat (ITT).||Units on a scale||Standard Deviation|Median
803244|NCT00982280|Secondary|Change From Baseline in the Western Ontario McMaster Questionnaire (WOMAC) Global Score Assessing Pain, Disability and Joint Stiffness of the Knee Over the Last Week at Week 12|The WOMAC is a self-administered questionnaire and has 24 questions: Pain, Stiffness and Physical Function. The possible scores range from 0-20 for pain, 0-8 for stiffness, 0-68 for physical function and these are then summed 0-96 for the global score. The negative value indicates that there has been an improvement since baseline, the higher the value the greater the change since baseline.|12 weeks|Intention to treat (ITT).||Units on a scale||Standard Deviation|Mean
803245|NCT00982280|Secondary|Change From Baseline in the Western Ontario McMaster Questionnaire (WOMAC) Global Score Assessing Pain, Disability and Joint Stiffness of the Knee Over the Last Week at Week 6|The WOMAC is a self-administered questionnaire and has 24 questions: Pain, Stiffness and Physical Function. The possible scores range from 0-20 for pain, 0-8 for stiffness, 0-68 for physical function and these are then summed 0-96 for the global score. The negative value indicates that there has been an improvement since baseline, the higher the value the greater the change since baseline.|6 weeks|Intention to treat (ITT).||Units on a scale||Standard Deviation|Mean
803246|NCT00982280|Secondary|Baseline Western Ontario McMaster Questionnaire (WOMAC) Global Score Assessing Pain, Disability and Joint Stiffness of the Knee|Western Ontario McMaster Questionnaire (WOMAC) Global Score: WOMAC is measured with a Likert ordinal scale (the participant gives one of 5 possible answers) A higher score indicate that a symptom is bothersome or disabling. The WOMAC is a self-administered questionnaire and has 24 questions: Pain, Stiffness and Physical Function. The possible scores range from 0-20 for pain, 0-8 for stiffness, 0-68 for physical function and these are then summed 0-96 for the global score. A lower score indicates a lower level of symptoms and or disability.|Baseline|Intention to treat (ITT).||Units on a scale||Standard Deviation|Mean
803247|NCT00982280|Secondary|Change in Average Pain Intensity After 12 Weeks of Tapentadol PR Treatment.|"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. The value indicates the change from the baseline value on the 0 to 10 scale. A Negative value indicates a reduction in pain intensity from the baseline average pain intensity."|Baseline; Week 12 (12 weeks)|Intention to treat (ITT)||Units on a scale||Standard Deviation|Mean
803248|NCT00982280|Secondary|Change in Average Pain Intensity After 6 Weeks of Tapentadol PR Treatment.|"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. The value indicates the change from the baseline value on the 0 to 10 scale. A Negative value indicates a reduction in pain intensity from the baseline average pain intensity."|Baseline; Week 6 (6 weeks)|Intention to treat||Units on a scale||Standard Deviation|Mean
803249|NCT00982280|Secondary|Average Pain Intensity Before the Start of Tapentadol Treatment|"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Baseline|Intention to Treat||units on a scale||Standard Deviation|Mean
803250|NCT00982280|Primary|Responder Rate|Participants were considered responders if they reported the same or less average pain intensity over a 3 day period after 6 weeks of tapentadol PR treatment as with their previous analgesic treatment.|6 weeks|Per Protocol Set. Last Observation Carried Forward (LOCF).||Participants|||Number
803251|NCT00982345|Primary|17-item Hamilton Depression Rating Scale (HDRS)|Standard 17-item rating scale for depression used in clinical trials. A score of 0-7 is considered to be normal. 8 - 13 mild depression. Scores of 20 or higher indicate moderate, severe, or very severe depression, and are usually required for entry into a clinical trial. Range of score: 0 - 50.|Started: March 2009 Ending March 2011|||units on a scale||Standard Deviation|Mean
803302|NCT00991081|Secondary|Intention to Quit|Category: Psychological Outcome Instrument: 3-item inventory, Likert scale from 1 to 7 Measures: Intention, confidence, and expectation of quitting smoking Range: 3-21 Direction: Higher values represent increased intention to quit|Within 1 week of first clinical call|First psychological outcome analyses include participants who received the first clinical call (n = 33)||units on a scale||Standard Deviation|Mean
803252|NCT00982410|Secondary|As-treated Analysis: The Impact of Pain on Activities and Functioning: General Activity Score (WHY MPI)|The WHY MPI General Activity score is a composite construct designed to assess the extent to which physical pain impacts various aspects of daily living. The outcome measure below represents the average WHY MPI General Activity score in each Arm/Group, across the entire follow-up period, adjusted for baseline WHY MPI General Activity score, but restricted here to study participants that partook in at least one treatment group session.|Baseline, 3mo, 6mo, 12mo follow-up|||units on a scale||Standard Error|Mean
803253|NCT00982410|Secondary|As-treated Analysis: Pain Intensity, as Measured by Average Pain Within the Last Week (NRS-1)|Per study protocol, participants were asked to attend 10 sessions, which comprised the intervention for CBT participants and educational support for EUC participants. Some participants in each group did not attend any sessions, yet participated in follow-up assessments. The As-treated analysis was undertaken to evaluate the impact of the intervention, among participants that attended at least 1 session. As in the Primary Analysis, average pain last week (NRS-1) is a scale ranging from 0 (no pain) to 10 (worst possible pain). The results reported below are based on longitudinal repeated measures modeling, adjusted for baseline NRS-1 average pain level. The variance was modeled to account for time interval (3-mo, 6-mo, 12-mo), and for session block; at the time of randomization, participants were assigned to blocks for a series of 10 sessions, in parallel for the intervention and control. Session blocks were utilized as a blocking variable to address between-block variation|Baseline, 3-, 6-, 12-months|||units on a scale||Standard Error|Mean
803254|NCT00982410|Secondary|Self-efficacy of Physical Functioning|The CPSS is a 22-item questionnaire designed to measure chronic pain patients' perceived self-efficacy to cope with the consequences of chronic pain (Anderson et al. 1995). The CPSS subscale, self-efficacy for physical function (FSE), utilized to assess management of pain-related disability, with respect to several aspects of daily functioning. This scale have high reliability. Scores range from 10-100, with higher scores representing a better outcome. The outcome measure below represents the average CPSS FSE score in each Arm/Group, across the entire follow-up period, and was adjusted for baseline level of CPSS FSE.|Baseline, 3-, 6-, 12- months|||units on a scale||Standard Error|Mean
803255|NCT00982410|Secondary|Self-efficacy of Pain Management|As measured via CPSS PSE score at each time point. The CPSS is a 22-item questionnaire designed to measure chronic pain patients' perceived self-efficacy to cope with the consequences of chronic pain (Anderson et al. 1995). The CPSS PSE subscale is a measure of self-efficacy for pain management. These scales have high reliability. Scores range from 10-100, with higher scores representing a better outcome. The outcome measure below represents the average CPSS PSE score in each Arm/Group, across the entire follow-up period, and was adjusted for baseline CPSS PSE.|Baseline, 3-, 6-, 12- months|||units on a scale||Standard Error|Mean
803256|NCT00982410|Primary|Pain Tolerance|Pain tolerance was measured by the amount of time the participant could hold their hand immersed in a vessel of cold water in seconds. The maximum allowed duration of the test was two minutes. The outcome measure below represents the average duration of task in each Arm/Group, across the entire follow-up period, and was adjusted for baseline level of pain tolerance.|Baseline, 3-,6-,12-months|||seconds||Standard Error|Mean
803257|NCT00982410|Primary|Drug Use|# days used illicit drugs in the past 30 days, as assessed via timeline follow-back (TLFB) calendars. Use of illicit drugs and misuse of prescription drugs (e.g., Rx opioids) were recorded for the 30 days prior to the follow-up visit. #days in a controlled environment (e.g., hospitalization, incarceration) also recorded to identify the duration of days at risk. The outcome measure below represents the average #days drug use in each Arm/Group, across the entire follow-up period, and was adjusted for baseline TLFB #days used illicit drugs.|Baseline, 3-, 6-, 12- months|||#Days used||Standard Error|Mean
803258|NCT00982410|Primary|Alcohol Use|#days used alcohol in the past 30 days, as assessed via timeline follow-back(TLFB) calendars. #days in a controlled environment (e.g. hospitalization, incarceration) also recorded to identify the duration of days at risk. The outcome measure below represents the average #days alcohol use in each Arm/Group, across the entire follow-up period, and was adjusted for baseline TLFB #days used alcohol.|Baseline, 3-, 6-, 12- months|||#Days used||Standard Error|Mean
803259|NCT00982410|Primary|The Impact of Pain on Activities and Functioning: General Activity Score (WHY MPI)|The WHY MPI General Activity score is a composite construct designed to assess the extent to which physical pain impacts various aspects of daily living. Aspects include ability to perform chores inside the home, activities away from the home, and social functioning. The outcome measure below represents the average pain levels in each Arm/Group, across the entire follow-up period, and was adjusted for baseline WHY MPI General Activity score.|Baseline, 3-,6-, 12-month|||units on a scale||Standard Error|Mean
803260|NCT00982410|Primary|Pain Intensity, as Measured by Average Pain Within the Last Week (NRS-1)|The outcome measure below represents the average pain levels in each Arm/Group, across the entire follow-up period. Average pain in the last week (NRS-1) is a scale ranging from 0 (no pain) to 10 (worst possible pain). The results reported below are based on longitudinal repeated measures modeling, adjusted for baseline NRS-1 average pain level. The variance was modeled to account for time interval (3-mo, 6-mo, 12-mo), and for session block; at the time of randomization, participants were assigned to blocks for a series of 10 sessions, in parallel for the intervention and control. Session blocks were utilized as a blocking variable to address between-block variation.|Baseline, 3-, 6-, & 12-months|||units on a scale||Standard Error|Mean
803261|NCT00982423|Secondary|Plasma Cyclic Guanosine Monophosphate (cGMP) at Baseline and in Response to Decreasing Furosemide Dose|Any change in atrial filling pressures leads to the release of atrial natriuretic peptides (ANP) from the heart. Once released, atrial peptides exert potent direct vasodilator and natriuretic actions by virtue of the ability to increase their intracellular second messenger, cGMP. Plasma cGMP correlates closely with the severity of congestive heart failure.|3 weeks, approximately 6 weeks|||pg/mL||Standard Deviation|Mean
803262|NCT00982423|Secondary|Angiotensin II at Baseline and in Response to Decreasing Furosemide Dose|Renin activates the renin-angiotensin system by cleaving angiotensinogen, produced by the liver, to yield angiotensin I, which is further converted into angiotensin II by the angiotensin-converting enzyme (ACE) primarily within the capillaries of the lungs. Angiotensin II then constricts blood vessels, increases the secretion of antidiuretic hormone (ADH) and aldosterone, and stimulates the hypothalamus to activate the thirst reflex, each leading to an increase in blood pressure.|3 weeks, approximately 6 weeks|||pg/mL||Standard Deviation|Mean
812465|NCT01070784|Primary|Clinical Laboratory Test: Clinical Chemistry- S-Alanine Aminotransferase|Change from baseline|Baseline and 52 week after|||U/L||Standard Deviation|Mean
803263|NCT00982423|Secondary|Plasma Renin Activity at Baseline and in Response to Decreasing Furosemide Dose|Plasma renin activity is a measure of the activity of the plasma enzyme renin, which plays a major role in the body's regulation of blood pressure, thirst, and urine output. Renin is an enzyme that hydrolyses angiotensinogen secreted from the liver into the peptide angiotensin I. Renin's primary function is to cause an increase in blood pressure, leading to restoration of perfusion pressure in the kidneys.|3 weeks, approximately 6 weeks|||ng/mL/hr||Standard Deviation|Mean
803264|NCT00982423|Secondary|Aldosterone at Baseline and in Response to Decreasing Furosemide Dose|Aldosterone is part of the renin–angiotensin-aldosterone system (RAAS). Drugs that interfere with the secretion or action of aldosterone are in use as antihypertensives, like lisinopril, which lowers blood pressure by blocking the angiotensin-converting enzyme (ACE), leading to lower aldosterone secretion. The net effect of these drugs is to reduce sodium and water retention but increase retention of potassium.|3 weeks, approximately 6 weeks|||ng/dL||Standard Deviation|Mean
803265|NCT00982423|Secondary|Renal Plasma Flow at Baseline and in Response to Decreasing Furosemide Dose|Effective renal plasma flow (eRPF) is a measure used to calculate renal plasma flow (RPF) and hence estimate renal function. Renal plasma flow is the volume of blood plasma that flows through the kidneys per unit time, measured as ml/min.|3 weeks, approximately 6 weeks|||ml/min||Standard Deviation|Mean
803266|NCT00982423|Primary|Renal Function as Measured by Glomerular Filtration Rate (GFR) at Baseline and in Response to Decreasing Furosemide Dose|Kidney function was measured by GFR determined by iothalamate clearance. GFR describes the flow rate of filtered fluid through the kidney measured in milliliters per minute per 1.73 m^2 of body surface area. A lower GFR means the kidney is not filtering normally. An estimated GFR of less than 60 mg/min/1.73 m^2 of body surface area is considered to be impaired kidney function.|3 weeks, approximately 6 weeks|||ml/min||Standard Deviation|Mean
803267|NCT00982488|Primary|Number of Participants Who Died and Had Serious Adverse Events (SAEs), Related SAEs, Adverse Events (AEs) Leading to Discontinuation, Related AEs Leading to Discontinuation, Related AEs, and Related AEs of Special Interest|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=drug-related; having certain, probable, possible, or unknown relationship to study drug.|Day 1 of treatment through a maximum of 82 months + 30 days|All participants who received at least 1 dose of study drug||Participants|||Number
803268|NCT00982553|Primary|Raltegravir Maximum Plasma Concentrations When Co-administered|On day 20 participants were administered raltegravir 400 mg and ribavirin 800 mg this was followed by intensive pharmacokinetic testing at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 12 hours.|Day 20|||ng/mL||95% Confidence Interval|Geometric Mean
803269|NCT00982553|Primary|Ribavirin Maximum Plasma Concentration When Co-administered|On day 20 participants were administered raltegravir 400 mg and ribavirin 800 mg this was followed by intensive pharmacokinetic testing at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 12 hours.|Day 20|||ng/mL||95% Confidence Interval|Geometric Mean
803270|NCT00982553|Primary|Raltegravir Alone Maximum Plasma Concentration|After a 14 day wash out participants took raltegravir 400 mg twice daily for 4 days. on day 19 they attended for intensive pharmacokinetic tests at 0 (pre-dose of raltegravir 400mg)then 0.5, 1, 2, 3, 4, 6, 8 and 12 hours|Day 19|||ng/mL||95% Confidence Interval|Geometric Mean
803271|NCT00982553|Primary|Ribavirin Alone Maximum Plasma Concentration|On day 1 participants were administered a single dose of Ribavirin 800mg and then intensive pharmacokinetic blood samples were collected at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 and 12 hours|Day 1|Per protocol||ng/mL||95% Confidence Interval|Geometric Mean
803272|NCT00982592|Secondary|Incidence of Toxicities (grades1 and 2)|Defined as percentage of patients who experienced a toxicity with grade 1 or 2 (worst grade) related to the protocol therapy. Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0.|Up to 4 years|All the patients who started the treatment.||percentage of patients|||Number
803273|NCT00982592|Secondary|Incidence of Toxicities (Grade 3 and Higher)|Defined as percentage of patients who experienced a toxicity with grade 3 or higher related to the protocol therapy. Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0|Up to 4 years|All the patients who started the treatment.||percentage of patients|||Number
803274|NCT00982592|Secondary|Overall Survival|Defined as time from randomization day until death from any cause.|up to 4 years|Intent-to-treat population||months||95% Confidence Interval|Median
803275|NCT00982592|Secondary|Objective Response Rate|Defined as the percentage of the patients who had complete response (CR) or partial response (PR) per RECIST 1.1.|Up to 4 years|Intent-to-treat population||percentage of patients|||Number
803276|NCT00982592|Primary|Median Progression-free Survival (PFS)|PFS is defined as the time from randomization until objective tumor progression or death from any cause and is evaluated per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.|up to 4 years|Intent-to-treat population||months||95% Confidence Interval|Median
803277|NCT00982644|Primary|Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)|Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.|Week 0 to Week 104 + 7 days of follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator in the main trial including subjects carried through to the extension trial.||Events/100 years of patient exposure|||Number
803303|NCT00991081|Secondary|Fatalism|Category: Psychological Outcome Instrument: Powe Fatalism Inventory, 10-item, revised Measures: belief in inevitability of smoking status Range: 0-10 Direction: Higher values represent increased fatalism beliefs|12 weeks after Target Quit Date|Follow-up psychological outcome analyses include only those participants not lost to follow-up (n = 30)||units on a scale||Standard Deviation|Mean
808121|NCT01020123|Secondary|Weight, Change From Baseline|Summary statistic of change from baseline|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 244 in CSR)||kg||Standard Deviation|Mean
803278|NCT00982644|Secondary|Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.|Week 0 to Week 52 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator.||Episodes/100 years of patient exposure|||Number
803279|NCT00982644|Secondary|Extension Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 104|Mean of 9-point SMPG at 104 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast.|Week 104|The FAS included all randomised subjects in the main trial including subjects carried through to the extension trial and missing data was imputed using LOCF. For 140 subjects all 9-point SMPG values were missing.||mmol/L||Standard Deviation|Mean
803280|NCT00982644|Secondary|Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 52|Mean of 9-point SMPG at 52 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast.|Week 52|The FAS included all randomised subjects and missing data was imputed using LOCF. For 126 subjects all 9-point SMPG values were missing.||mmol/L||Standard Deviation|Mean
803281|NCT00982644|Secondary|Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment|Change from baseline in HbA1c after 104 weeks of treatment|Week 0, Week 104|The FAS included all randomised subjects in the main trial including subjects carried through to the extension trial and missing data was imputed using LOCF.||percentage of glycosylated haemoglobin||Standard Deviation|Mean
803282|NCT00982644|Primary|Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.|Week 0 to Week 104 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator in the main trial including subjects carried through to the extension trial.||Episodes/100 years of patient exposure|||Number
803283|NCT00982644|Primary|Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 104 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator in the main trial including subjects carried through to the extension trial.||Episodes/100 years of patient exposure|||Number
803284|NCT00982644|Secondary|Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 52 + 7 days follow up|The safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or its comparator.||Episodes/100 years of patient exposure|||Number
803285|NCT00982644|Primary|Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment|Change from baseline in HbA1c after 52 weeks of treatment|Week 0, Week 52|The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF).||percentage of glycosylated haemoglobin||Standard Deviation|Mean
803286|NCT00982657|Secondary|Number of Participants With Anti- CVX-060 Antibodies||Baseline up to 28 days after last CVX-060 dose|The study was terminated during the Phase 1b phase by the sponsor prematurely. Due to the decision of not conducting the phase II portion of the study, no Anti-CVX-060 antibody assessment was conducted.|||||
803287|NCT00982657|Secondary|Duration of Response|Duration of response is defined as the time from the first documentation of objective tumor response to the first documentation of objective tumor progression or death due to any cause, whichever occurs first. Participants last known to be progression free are censored at the date of the last objective disease assessment that verified lack of disease progression.|Baseline up to 7 days post last dose of study medication|Duration of response was not calculated as there were no participants with objective response.|||||
803288|NCT00982657|Secondary|Percentage of Participants With Objective Response|Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. Per RECIST v1.0: CR defined as disappearance of all target lesions and non-target lesions. PR defined as >= 30% decrease in sum of the longest diameters (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non target lesions.|Baseline up to 7 days post last dose of study medication|Safety Analysis set consisted of all participants who received at least 1 dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||Percentage of participants||95% Confidence Interval|Number
803324|NCT00991939|Secondary|The Percentage of Patients Who Remain Free of All ITP Therapy With a Platelet Count of ≥ 50,000 From 180 Through 365 Days After Study Entry||From 180 days through 365 days after study entry|Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.|||||
803289|NCT00982657|Secondary|Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) and Non-Serious Adverse Events (Non-SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre treatment state.|Baseline up to 28 days post last dose of study medication|Safety Analysis set consisted of all participants who received at least 1 dose of study medication.||Participants|||Number
803290|NCT00982657|Secondary|Serum Angiopoietin-2 (Ang-2) and Plasma Vascular Endothelial Growth Factor (VEGF) Levels||Ang-2 (Day 1, 2, 5, 8, 22, 29 Cycle 1, Day 1 Cycle 2 up to Cycle 28); VEGF (Day 1, 8, 15, 22 Cycle 1, Day 1 Cycle 2 up to Cycle 28)|The study was terminated during the Phase 1b phase by the sponsor prematurely. Due to the decision of not conducting the phase II portion of the study, pharmacodynamics assessment was not conducted.|||||
803291|NCT00982657|Secondary|Number of Participants With Dose-limiting Toxicities (DLT)|DLT included grade 4 neutropenia of >= 3 day duration or with grade 4 neutropenia associated with fever; grade 4 thrombocytopenia for >= 3 consecutive days; Proteinuria of >=2 grams (g) per 24 hours; inability to resume to CVX-060 or sunitinib within 14 days of scheduled administration due to treatment related toxicity; any Grade 3 nonhematologic toxicity except nausea, vomiting, and diarrhea; Grade 3 nausea, vomiting, or diarrhea which persists for >=48 hours; Any >= Grade 4 non-hematologic toxicity; Any additional hematological or non-hematological toxicity for which dose reduction was required or for which patient was discontinued from the trial.|Baseline up to 28 days post last dose of study medication|Safety Analysis set consisted of all participants who received at least 1 dose of study medication.||participants|||Number
803292|NCT00982657|Secondary|Pharmacokinetic Parameters of CVX-060|Pharmacokinetic parameters Area under the Curve (AUC), Maximum Observed Serum Concentration (Cmax), Minimum Observed Serum Trough Concentration (Cmin), Clearance (CL), terminal elimination half life (t1/2) were planned to be analyzed.|Pre-dose on Day 1 Cycle 1 ; post-dose on Day 1, 5, 8, 15, 22, 29 Cycle 1 , Day 1 Cycle 2, to Cycle 28 , end of study (7 days post last dose of study medication), follow-up visit (28 days post last dose of study medication)|The study was terminated during the Phase 1b phase by the sponsor prematurely. Due to the decision of not conducting the phase II portion of the study,pharmacokinetics assessment was not conducted.|||||
803293|NCT00982657|Primary|Progression-free Survival (PFS)|PFS was defined as the time from the first dose date to the first documentation of disease progression or death due to any cause, whichever occurred first.|Baseline tumor progression/clinical deterioration or death (up to 28 days post last dose of study medication)|The study was terminated during the Phase 1b phase by the sponsor prematurely. Due to the decision of not conducting the Phase II portion of the study.The PFS endpoint was a pre-specified endpoint for the Phase II portion of the study, and was therefore not assessed.|||||
803294|NCT00982657|Primary|Maximum Tolerated Dose (MTD)|The MTD was defined as the dose level at which less than or equal to (<=) 1/6 participants experienced Dose Limiting Toxicity (DLT) during the first cycle of treatment with the next higher dose having >= 2/6 participants with DLT.|Baseline up to Cycle 1( Day 1 to Day 42)|The study was terminated during the Phase 1b phase by the sponsor prematurely. Due to the decision of not conducting the Phase II portion of the study, no MTD was assessed.|||||
803295|NCT00990964|Primary|Subjects Without a Left-heart Lead and Delivery Catheter Related Complication|A left-heart lead and delivery related complication was defined as a complication, an adverse event that resulted in death, any termination of significant device function or invasive intervention, that resulted from the presence of or performance (intended or otherwise) of the Medtronic left-heart lead or Attain Family of delivery catheters. All adverse events were adjudicated by an Adverse Event Advisory Committee (AEAC).|Implant to 3 months|||participants|||Number
803296|NCT00990964|Primary|Subjects Successfully Implanted With an Attain Family Left-heart Lead Using an Attain Family Delivery Catheter|Implant success was defined as final successful placement of the Attain Family left-heart lead in the coronary vein branches utilizing the Attain Family of delivery catheters.|Implant|||participants|||Number
803297|NCT00991081|Secondary|Threat Minimization|Category: Psychological Outcome Instrument: 2-item inventory, Likert scale from 1 to 7 Measures: Perceived presence of factors that would reduce personal smoking risks Range: 2-14 Direction: Higher values represent increased risk minimization|Within 1 week of first clinical call|First psychological outcome analyses include participants who received the first clinical call (n = 33)||units on a scale||Standard Deviation|Mean
803298|NCT00991081|Secondary|Self-Efficacy|Category: Psychological Outcome Instrument: 3-item inventory, Likert scale from 1 to 7 Measures: Perceived ability to quit smoking in the next month Range: 3-21 Direction: Higher values represent increased self-efficacy|Within 1 week of first clinical call|First psychological outcome analyses include participants who received the first clinical call (n = 33)||units on a scale||Standard Deviation|Mean
803299|NCT00991081|Secondary|Risk Perception|Category: Psychological Outcome Instrument: 4-item inventory, Likert scale from 1 to 5 Measures: Perceived personal health risks from smoking Range: 4-20 Direction: Higher values represent increased perception of risk|Within 1 week of first clinical call|First psychological outcome analyses include participants who received the first clinical call (n = 33)||units on a scale||Standard Deviation|Mean
803300|NCT00991081|Secondary|Perceived Control|Category: Psychological Outcome Instrument: 3-item inventory, Likert scale from 1 to 7 Measures: Control over ability to quit smoking in the next month Range: 3-21 Direction: Higher values represent increased sense of control|Within 1 week of first clinical call|First psychological outcome analyses include participants who received the first clinical call (n = 33)||units on a scale||Standard Deviation|Mean
803301|NCT00991081|Secondary|Motivation|Category: Psychological Outcome Instrument: Single item, Likert scale from 1 to 7 Measures: Desire to quit smoking Range: 1-7 Direction: Higher values represent increased motivation to quit|Within 1 week of first clinical call|First psychological outcome analyses include participants who received the first clinical call (n = 33)||units on a scale||Standard Deviation|Mean
803325|NCT00991939|Secondary|The Percentage of Patients Who Remain Free of All ITP Therapy With a Platelet Count of ≥ 150,000 From 180 Through 365 Days After Study Entry||From 180 days through 365 days after study entry|Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.|||||
803304|NCT00991081|Secondary|Depression|Category: Psychological Outcome Instrument: Center for Epidemiologic Studies Depression Scale (CES-D) Measures: Interest in participating in recommended treatment plan Range: 0-60 Direction: Higher values represent increased symptoms of depression|Within 1 week of first clinical call|First psychological outcome analyses include participants who received the first clinical call (n = 30)||units on a scale||Standard Deviation|Mean
803305|NCT00991081|Secondary|Treatment Interest Scale|Category: Treatment Acceptability Measures: Interest in participating in recommended treatment plan Range: 1-10 Direction: Higher values represent higher treatment interest|Within 1 week of first clinical call|First treatment satisfaction analyses include participants who received the first clinical call (n = 33)||units on a scale||Standard Deviation|Mean
803306|NCT00991081|Secondary|Satisfaction Scale|Category: Treatment Acceptability Measures: Overall satisfaction with the clinician Range: 4-20 Direction: Higher values represent higher satisfaction|Within 1 week of first clinical call|First treatment satisfaction analyses include participants who received the first clinical call (n = 33)||units on a scale||Standard Deviation|Mean
803307|NCT00991081|Secondary|Communication Scale|Category: Treatment Acceptability Measures: Quality of verbal interaction and responsiveness during counseling sessions Range: 4-20 Direction: Higher values represent greater interaction and responsiveness|Within 1 week of first clinical call|First treatment satisfaction analyses include participants who received the first clinical call (n = 33)||units on a scale||Standard Deviation|Mean
803308|NCT00991081|Secondary|Trust Scale|Category: Treatment Acceptability Measures: Trust in the clinician Range: 5-30 Direction: Higher values represent higher trust|Within 1 week of first clinical call|First treatment satisfaction analyses include participants who received the first clinical call (n = 33)||units on a scale||Standard Deviation|Mean
803309|NCT00991081|Secondary|Morisky Adherence Scale|Category: Treatment Acceptability Measures: Treatment Compliance Range: 0-8 Direction: Higher values represent higher compliance|12 weeks after Target Quit Date|Follow-up treatment satisfaction analyses includes only those participants not lost to follow-up (n = 30)||units on a scale||Standard Deviation|Mean
803310|NCT00991081|Primary|Continuous Abstinence at 12 Weeks Post Target Quit Date|"Participants reporting continuous tobacco-use abstinence 12 weeks after their Target Quit Date, whose salivary cotinine levels confirmed their abstinence, were counted as abstinent. All others were recorded as not abstinent."|12 weeks after Target Quit Date|All randomized participants were included in the data analysis.||participants|||Number
803311|NCT00991185|Primary|CSF:Serum Ratio of Vancomycin|CSF:serum ration of vancomycin|within 1 week of drug administration|||ratio||Full Range|Median
803312|NCT00991809|Secondary|Pain Threshold|The amount of time (in seconds) before the participant first verbally reports feeling pain after placing hand in 4 degree Celsius circulating water bath at the 30 minute time point. Truncated at 300 seconds for safety purposes.|8 sessions over 4-6 weeks|One person in the diphenhydramine group was dropped from analysis, even though he completed the study as he tolerated cold pressor testing for the maximum amount of time in sessions 2-8.||seconds||Full Range|Mean
803313|NCT00991809|Primary|Pain Tolerance|The participant places their hand in a water bath kept at 4 degrees Celsius (cold pressor test). They then continue to hold the hand in the water bath until they can no longer tolerate the pain (pain tolerance) or until the end of the testing (truncated at 300 seconds for safety purposes). Reported as the mean (time to hand removal in seconds) at the 30 minute time point.|8 sessions over 4-6 weeks|One person in the diphenhydramine group was dropped from analysis, even though he completed the study as he tolerated cold pressor testing for the maximum amount of time in sessions 2-8.||seconds||Full Range|Mean
803314|NCT00991887|Primary|Mayo Elbow Performance Score|Mayo Elbow Performance Score (MEPS) is an outcome tool based on a 100 point scale, with higher score indicating better function. It measures pain, stability, function, and motion. The score is graded on the basis of the MEPS as excellent (>=90), good (75-89), fair (60-74), and poor (<60).|6 month|Patients with elbow trauma treated with radiation therapy in the prevention of post-traumatic heterotopic ossification. Subjects are randomized to either radiation therapy or no radiation therapy.||units on a scale||Standard Deviation|Mean
803315|NCT00991939|Secondary|The Percentage of Patients With Severe Adverse Events Attributable to Steroid Therapy||Through 1 year after study entry|Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.|||||
803316|NCT00991939|Secondary|The Percentage of Patients Not Completing Study Therapy||49 days after study entry|Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.|||||
803317|NCT00991939|Secondary|The Incidence and Severity of Bleeding as Defined by a Customized Bleeding Score||Through 365 days after study entry|Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.|||||
803318|NCT00991939|Secondary|Change in the Quality of Life From Randomization to Weeks 4, 8 and End of Study, Determined Using the SF-36 Health Survey||Weeks 4, 8, and 52 after study entry|Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.|||||
803319|NCT00991939|Secondary|The Percentage of Patients Undergoing Splenectomy||Through 365 days after study entry|Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.|||||
803320|NCT00991939|Secondary|The Percentage of Platelet Counts ≥ 150,000/μl After Day 60 (If a Subject Receives an Acute Therapeutic Intervention, the Next Protocol-specified Platelet Count Will be Excluded From This Analysis, as it May be Influenced by the Intervention.)||From 60 days through 365 days after study entry|Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.|||||
803321|NCT00991939|Secondary|The Percentage of Platelet Counts ≥ 50,000/μl After Day 60 (If a Subject Receives an Acute Therapeutic Intervention, the Next Protocol-specified Platelet Count Will be Excluded From This Analysis, as it May be Influenced by the Intervention.)||From 60 days through 365 days after study entry|Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.|||||
803322|NCT00991939|Secondary|The Percentage of Patients Receiving Acute Therapeutic Intervention Beyond the First 60 Days After Study Entry||From 60 days through 365 days after study entry|Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.|||||
803323|NCT00991939|Secondary|The Percentage of Patients Receiving Acute Therapeutic Intervention During the First 60 Days After Study Entry||Through 60 days after study entry|Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.|||||
803326|NCT00991939|Secondary|The Percentage of Patients With Platelets ≥ 50,000/μl at 365 Days Who Are Off All Treatment, Have Received ≤ 2 Acute Therapeutic Interventions for Thrombocytopenia, and Whose Last Acute Therapeutic Intervention Occurred at Least 90 Days Before Day 365||365 days after study entry|Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.|||||
803327|NCT00991939|Secondary|The Percentage of Patients Who Remain Free of All ITP Therapy With a Platelet Count ≥ 150,000/μl From 60 Days Through 365 Days After Study Entry||From 60 days through 365 days after study entry|Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.|||||
803328|NCT00991939|Primary|The Percentage of Patients in Each Treatment Arm Who Remain Free of All ITP Therapy With a Platelet Count ≥ 50,000/μl From 60 Days Through 365 Days After Study Entry.||From 60 days through 365 days after study entry.|||percentage of subjects|||Number
803329|NCT00991952|Primary|Overall Response Rate|Response was determined as indicated in the protocol.|From the start of treatment for up to 3 months|||participants|||Number
803330|NCT00992017|Secondary|Response to Seasonal Trivalent Influenza Vaccine (TIV)|Presents the value of the median titer as well as the interquartile range at study entry. Antibodies to seasonal Influenza vaccine were measured using an HAI assay. The potential titer read-outs from the assay used were <10 (considered undetectable), 10, 20, 40, 60, 80, 160, 320, 640, and >=1280.|Measured at entry|Pregnant women who received the first H1N1 immunization.||titer||Inter-Quartile Range|Median
803331|NCT00992017|Secondary|Maternal Cell-mediated Immunity (CMI) Responses, as Measured by B-cell and T-cell Enzyme-linked Immunosorbent Spot (ELISPOT) Assay Values|The median and interquartile range (IQR) of B-Cell ELISPOT-measured IgG antibody-secreting cells (ASC)/10^6 PBMC and the median and interquartile range (IQR) of T-Cell ELISPOT-measured pH1N1 IFNgamma spot-forming cells (SFC)/10^6 PBMC.|Measured at entry, at 21 days after first dose of vaccine, at 10 days after second dose|The pregnant women who had not delivered prior to the evaluation, had received all doses of vaccine up to that timepoint and had sufficient samples for testing.||ASC or SFC/10^6 PBMC||Inter-Quartile Range|Median
803332|NCT00992017|Secondary|Infant GMT of Antibodies HAI|Presents the value of the geometric mean titer at each time point. Antibodies to Influenza A (H1N1) 2009 were measured using an HAI assay. The potential titer read-outs from the assay used were <10 (considered undetectable), 10, 20, 40, 60, 80, 160, 320, 640, and >=1280.|Measured at birth and at 3 and 6 months of age|The population consists of infants born to eligible women with nonmissing HAI titers, who had not delivered before the evaluation post second dose, and received two doses of vaccine. The N for analyses at birth, 3 and 6 months were 96, 87 and 52, respectively. Cord blood was used when available. Only some infants had a clinic visit at 6 months.||units on the HAI titer scale||95% Confidence Interval|Geometric Mean
803333|NCT00992017|Secondary|Maternal Geometric Mean Titers (GMT) of Antibodies HAI|Presents the value of the geometric mean titer at each time point. Antibodies to Influenza A (H1N1) 2009 were measured using an HAI assay. The potential titer read-outs from the assay used were <10 (considered undetectable), 10, 20, 40, 60, 80, 160, 320, 640, and >=1280.|Measured after the first and second doses of the vaccine, at delivery, and at 3 and 6 months after delivery|The population consists of eligible women with nonmissing HAI titers, who had not delivered before the evaluation post first or second dose, and received all vaccines up to that point, respectively. The N for analyses after the first and second vaccinations, at delivery, 3 and 6 months after were 104, 94, 102, 92 and 58, respectively.||titers||95% Confidence Interval|Geometric Mean
803334|NCT00992017|Secondary|Percent of Infants With an HAI Titer of >= 40|Antibodies to Influenza A (H1N1) 2009 were measured using an HAI assay. The potential titer read-outs from the assay used were <10 (considered undetectable), 10, 20, 40, 60, 80, 160, 320, 640, and >=1280. Seroprotection was defined as having a titer of >=40 following vaccination.|Measured at birth (via cord blood) and at 3 months and 6 months of age|The population consists of infants born to eligible women with nonmissing HAI titers, who had not delivered before the evaluation post second dose, and received two doses of vaccine. The N for analyses at birth, 3 and 6 months were 96, 87 and 52, respectively. Cord blood was used when available. Only some infants had a clinic visit at 6 months.||Percent of participants||95% Confidence Interval|Number
803335|NCT00992017|Secondary|Percent of Pregnant Women With an HAI Titer of >= 40 at Delivery, 3 Months and 6 Months After Delivery|Antibodies to Influenza A (H1N1) 2009 were measured using an HAI assay. The potential titer read-outs from the assay used were <10 (considered undetectable), 10, 20, 40, 60, 80, 160, 320, 640, and >=1280. Seroprotection was defined as having a titer of >=40 following vaccination.|Measured at delivery of the baby, and at 3 months and 6 months after delivery|The population consists of eligible pregnant women with nonmissing HAI titers, who had not delivered before the evaluation post second dose, and received two doses of vaccine. The N for the analyses of HAI titers at delivery, and at 3 and 6 months after were 102, 92 and 58, respectively. Only some women had a clinic visit at 6 months post delivery.||Percent of participants||95% Confidence Interval|Number
803336|NCT00992017|Primary|Percent of Pregnant Women With a Hemagglutination Inhibition (HAI) Titer of >= 40|Antibodies to Influenza A (H1N1) 2009 were measured using an HAI assay. The potential titer read-outs from the assay used were <10 (considered undetectable), 10, 20, 40, 60, 80, 160, 320, 640, and >=1280. Seroprotection was defined as having a titer of >=40 following vaccination.|Measured at 21 days after first dose and at 10 days after second dose of study vaccine|The analysis population consists of the eligible pregnant women with nonmissing HAI titers, who had not delivered prior to the evaluation, and had received all doses of vaccine up to that timepoint. The N for the analyses of HAI titers after the first and second vaccinations were 118 and 108, respectively.||Percent of participants||95% Confidence Interval|Number
803337|NCT00992017|Primary|Withholding of Second Vaccine Dose Due to Adverse Reactions Attributed to First Dose||Measured at Day 21|All 128 pregnant women who received at least one vaccination are included.||Participants|||Number
803338|NCT00992017|Primary|The Number of Participants Who Had at Least One AE Attributed to the Study Vaccine|Shows the number of participants who experienced any events that were thought to be at least possibly related to study treatment. Adverse Events were graded using the DAIDS Grading Severity of AEs (see Link under More Information), as follows: grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death.|Measured up to 6 months after delivery|All 128 pregnant women who received at least one vaccination are included.||Participants|||Number
808122|NCT01020123|Secondary|Pulse, Change From Baseline|Summary statistic of change from baseline|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 236 in CSR)||Beats/min||Standard Deviation|Mean
803339|NCT00992017|Primary|The Number of Participants Who Had at Least One Adverse Event (AE)|Shows the number of participants who had at least one adverse event (AE) in each category. These include: abnormal laboratory values, signs and symptoms, or diagnoses; solicited local AEs; and solicited systemic AEs. Adverse Events were graded using the DAIDS Grading Severity of AEs (see Link under More Information), as follows: grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death.|Measured up to 6 months after delivery|All 128 pregnant women who received at least one vaccination are included in this analysis.||Participants|||Number
803340|NCT00992056|Primary|Change in 24-hour Mean Systolic Blood Pressure by ABPM From Day 5 of Low Sodium to Day 10 of High Sodium||Day 5, Day 10|24 subjects were randomized. Three withdrew informed consent during the study. One was withdrawn during the washout period. One completed all phases of the study but had a faulty ABPM reading on the last determination||mmHg||95% Confidence Interval|Mean
803341|NCT00992108|Secondary|Clinical Response as Assessed by >20% Change From Baseline in Jaw Opening|maximum mandibular range of motion scores (measured as the maximum interincisal distance and compensating for occlusion)|baseline, 4 months|Participants completing the 4-month follow-up||participants|||Number
803342|NCT00992108|Secondary|Clinical Response as Assessed by >20% Change From Baseline in the Pressure Pain Threshold|measurements were obtained by placing examiner’s index finger of the examiner on the area of the trigger point (hyperirritable areas on skeletal muscle with palpable taut bands of muscle fibers) and exerting pressure until there was whitening of the nail bed. Pressure pain levels were rated subjectively by the participant and coded numerically as mild (1), moderate (2) to severe (3).|baseline, 4 months|Participants completing the 4-month follow-up||participants|||Number
803343|NCT00992108|Secondary|Clinical Response as Assessed by >20% Change From Baseline in the Jaw Functional Limitation Scale (JFLS) Global Score|"The JFLS contains 20 items that measure limitations across mastication, vertical jaw mobility, and verbal/emotional expression rated on a 0-10 scale where 0 = no limitation and 10 = severe limitation."|6 weeks|||participants|||Number
803344|NCT00992108|Primary|Clinical Response as Assessed by >20% Change From Baseline in the Jaw Functional Limitation Scale (JFLS) Global Score|"The JFLS contains 20 items that measure limitations across mastication, vertical jaw mobility, and verbal/emotional expression rated on a 0-10 scale where 0 = no limitation and 10 = severe limitation."|4 months|participants who completed the 4-month follow-up||participants|||Number
803345|NCT00992186|Other Pre-specified|Time to Worsening in Eastern Cooperative Oncology Group (ECOG) Status Score|A worsening in ECOG performance status score was defined as greater than or equal to 1-point increase from Baseline. Time to worsening is defined as the number of days from first dose to the first day of worsening in ECOG score, or death, whichever occurred first. ECOG is a 5-point scale 0=Fully active, 1=Ambulatory, carry out work of sedentary nature, 2=Ambulatory, capable of all selfcare, 3=Capable of limited selfcare, confined to bed or chair more than 50% of waking hours, 4=Completely disabled, no selfcare, totally confined to bed or chair, 5=Dead.|Up to 2 weeks before first dose, pre-infusion, Week 4 after last dose of carlumab|Analysis population included all the participants who received at least 1 administration of carlumab.||Days||95% Confidence Interval|Median
803346|NCT00992186|Secondary|Half-life (t1/2)|The time measured for the serum concentration to decrease by one half.|Pre-dose and at the end of infusion for each Dose; 2, 4 hour (hr) and 1 week after Dose 1; 2 hr after Dose 4; Week 1, 4, 8 and 12 post-last dose|Analysis population included all the participants who received at least 1 administration of carlumab except those whose serum samples were missing at the end of infusion.||Days||Full Range|Median
803347|NCT00992186|Secondary|Area Under the Serum Concentration Versus Time Curve Between 0 And 14 Days (AUC 0-14d)||Pre-dose, at the end of infusion, 2, 4 hr and 1 week after end of infusion for the first dose|Analysis population included all the participants who received at least 1 administration of carlumab except those whose serum samples were missing at the end of infusion.||mcg*day/mL||Standard Deviation|Mean
803348|NCT00992186|Secondary|Maximum Observed Serum Concentration (Cmax)|The maximum observed analyte concentration was measured.|Pre-dose and at the end of infusion for each Dose; 2, 4 hour (hr) and 1 week after Dose 1; 2 hr after Dose 4; Week 1, 4, 8 and 12 post-last dose|Analysis population included all the participants who received at least 1 administration of carlumab.||mcg/mL||Standard Deviation|Mean
803349|NCT00992186|Secondary|Minimum Observed Serum Concentration (Cmin)||Pre-dose and at the end of infusion for each Dose; 2, 4 hour (hr) and 1 week after Dose 1; 2 hr after Dose 4; Week 1, 4, 8 and 12 post-last dose|Analysis population included all the participants who received at least 1 administration of carlumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||microgram/milliliter (mcg/mL)||Standard Deviation|Mean
803350|NCT00992186|Secondary|Duration of Radiologic Response|Radiologic response based on assessment of confirmed CR or PR according to RECIST. CR defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to less than 10 millimeter (mm). PR defined as at least 30% decrease in sum of the diameters of the target lesions taking as reference the Baseline sum diameters. Confirmed responses are those that persist on repeat imaging study for at least 4 weeks after initial documentation of response.|Up to 4 weeks before first dose, every 12 weeks after first dose, Week 12 after last dose of carlumab|Analysis population included all the participants who received at least 1 administration of carlumab. No data was available for this endpoint as no participant achieved CR or PR.|||||
803351|NCT00992186|Secondary|Time to Radiologic Response|Radiologic response based on assessment of confirmed CR or PR according to RECIST. CR defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to less than 10 millimeter (mm). PR defined as at least 30% decrease in sum of the diameters of the target lesions taking as reference the Baseline sum diameters. Confirmed responses are those that persist on repeat imaging study for at least 4 weeks after initial documentation of response.|Up to 4 weeks before first dose, every 12 weeks after first dose, Week 12 after last dose of carlumab|Analysis population included all the participants who received at least 1 administration of carlumab. No data was available for this endpoint as no participant achieved CR or PR.|||||
803594|NCT00993473|Secondary|Glycosylated Hemoglobin A1c (HbA1c): End of Treatment and Change From Baseline to End of Treatment (ANCOVA Estimates)|Assessed using an analysis of covariance (ANCOVA) model with treatment, and randomization strata (baseline number of CGM hypoglycemic excursions <0.5 events/24hours or ≥0.5 events/24 hours, and baseline HbA1c <8.5% or ≥8.5%) as fixed effects, and using the baseline value as covariate.|baseline, 6 months|Same as for primary endpoint: mITT population.||percent HbA1c||Standard Error|Least Squares Mean
803352|NCT00992186|Secondary|Percentage of Participants With Pain Response|Pain response is defined as 2-point decrease from Baseline in ‘worst pain’ intensity score (item 3) on the Brief Pain Inventory (BPI) questionnaire. The BPI is a nine-item questionnaire with 0 to 10 numeric rating scales in response to each item, where 0=No pain and 10=Pain as bad as you can imagine. Measure can be scored by item, with lower scores being indicative of less pain or pain interference.|Up to 2 weeks before first dose, every 4 weeks after first dose, Week 4 after last dose of carlumab|Analysis population included all the participants who received at least 1 administration of carlumab, had Baseline BPI ‘worst pain’ intensity score (item 3) more than or equal to 2, and at least 1 post-treatment pain evaluation. Participants with disease progression were considered to be evaluable, regardless of the post-dose evaluation.||Percentage of participants|||Number
803353|NCT00992186|Secondary|Percentage of Participants With Urinary Crosslinked N-Telopeptide of Type I Collagen (NTx) Response|Urinary NTx response for participants with elevated NTx level at Baseline (more than or equal to 50 nanomole per millimole (nmol/mmol)) is defined as a 30% reduction from Baseline NTx value, confirmed by a second NTx value 3 or more weeks later.|Up to 2 weeks before first dose, every 4 weeks after first dose, Week 4, 8, 12 after the last dose of carlumab|Analysis population included all the participants who received at least 1 administration of carlumab and had elevated urinary NTx level at Baseline (more than or equal to 50 nmol/mmol) and at least 1 post-treatment urinary NTx measurement. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||Percentage of participants|||Number
803354|NCT00992186|Secondary|Percentage of Participants With Prostate Specific Antigen (PSA) Response|The PSA response for participants with elevated PSA levels at Baseline (more than or equal to 5 nanogram per milliliter (ng/mL) is defined as at least a 50% reduction in PSA from the Baseline value, confirmed by a second PSA value measurement 3 or more weeks later.|Up to 2 weeks before first dose, every 4 weeks after first dose, Week 4, 8, 12 after the last dose of carlumab|Analysis population included all the participants who received at least 1 administration of carlumab and had a Baseline PSA more than or equal to 5 ng/mL and at least 1 post-treatment PSA measurement. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||Percentage of participants|||Number
803355|NCT00992186|Secondary|Overall Survival (OS)|The OS is defined as the time from the date of initiation of study treatment to death due to any cause. Participants were followed for 1 year after the last administration of carlumab for survival or until the end of study, whichever occurs first. For participants with unknown survival status as of the data cutoff date, OS was censored at the last date that the participant was known to be alive.|Week 8, 12, every 12 weeks up to 1 year after last dose of carlumab|Analysis population included all the participants who received at least 1 administration of carlumab.||Days||Full Range|Median
803356|NCT00992186|Secondary|Progression-Free Survival (PFS)|The PFS is defined as the time from the date of initiation of study treatment to the date of initial documented skeletal or extra-skeletal progressive disease, or date of death, whichever occurs first. A participant is considered to have extra-skeletal disease progression if the disease has progressed as per the Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria. A participant is considered to have skeletal disease progression if they have 1 post-baseline bone scan demonstrating 2 or more new skeletal lesions compared to Baseline and confirmed by a second bone scan 6 to 12 weeks later or with evidence of clinical progression.|Up to 4 weeks before first dose, every 12 weeks after first dose, Week 12 after last dose of carlumab|Analysis population included all the participants who received at least 1 administration of carlumab.||Days||95% Confidence Interval|Median
803357|NCT00992186|Secondary|Percentage of Participants With Objective Tumor Response|Objective response based on assessment of confirmed CR or PR according to RECIST. CR defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to less than 10 millimeter (mm). PR defined as at least 30 percent (%) decrease in sum of the diameters of the target lesions taking as reference the Baseline sum diameters. Confirmed responses are those that persist on repeat imaging study for at least 4 weeks after initial documentation of response.|Up to 4 weeks before first dose, every 12 weeks after first dose, Week 12 after last dose of carlumab|Analysis population included all the participants who received at least 1 administration of carlumab and had a measurable, non-measurable or bone lesion at Baseline and had at least 1 post-treatment tumor evaluation. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||Percentage of participants|||Number
803358|NCT00992186|Primary|Percentage of Participants With Composite Response|The composite response is measured by change from Baseline in skeletal lesions, extra-skeletal lesions, and prostate specific antigen (PSA) values. A participant is considered to have composite response, if 1 of the following responses occurs after the first dose of carlumab: (1) Complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST), (2) PSA response at 12 weeks and absence of skeletal and extra-skeletal progression or (3) Stable disease at 24 weeks defined as the absence of PSA, skeletal, or extra-skeletal progression.|Up to 4 weeks before first dose, every 12 weeks after first dose, Week 12 after last dose of carlumab|Analysis population included all the participants who received at least 1 administration of carlumab and had at least 1 post-baseline disease evaluation. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||Percentage of participants|||Number
803361|NCT00992394|Secondary|Physician Global Assessment (PGA) of Disease Activity at Week 52|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).|Week 52|The modified intent-to-treat (mITT) population will be the primary efficacy population and will correspond to all randomized subjects who have a baseline PGA and at least one postbaseline PGA.||Units on a scale||Standard Deviation|Mean
803362|NCT00992394|Secondary|Patient Psoriasis Satisfaction Questionnaire (PSSQ): I Would Like to Continue With my Current Psoriasis Treatment, at Baseline, Before Retreatment, and at the End of Retreatment|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).|Baseline to Week 52|mITT population was the primary efficacy population and corresponded to all randomized subjects who has a baseline PGA and at least one postbaseline PGA.||Number of Participants|||Number
803363|NCT00992394|Secondary|Patient Psoriasis Satisfaction Questionnaire (PSSQ): How Satisfied Were You With Your Psoriasis Treatment in General? at Baseline, Before Retreatment, and at the End of Retreatment|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).|Baseline to Week 52|mITT population was the primary efficacy population and corresponded to all randomized subjects who has a baseline PGA and at least one postbaseline PGA.||Number of Participants|||Number
803364|NCT00992394|Secondary|Patient Psoriasis Satisfaction Questionnaire (PSSQ): How Your Skin Affects Your Social and Leisure Activities, at Baseline, Before Retreatment, and at the End of Retreatment|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).|Baseline to Week 52|mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA.||Number of Participants|||Number
803365|NCT00992394|Secondary|Patient Psoriasis Satisfaction Questionnaire (PSSQ): How Others Respond to Your Personal Appearance at Work/School, at Baseline, Before Retreatment, and at the End of Retreatment|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).|Baseline to Week 52|mITT) population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA.||Number of Participants|||Number
803366|NCT00992394|Secondary|Patient Psoriasis Satisfaction Questionnaire (PSSQ): Fatigue, at Baseline, Before Retreatment, and at the End of Retreatment|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).|Baseline to Week 52|mITT population was the primary efficacy population and corresponded to all randomized subjects who has a baseline PGA and at least one postbaseline PGA.||Number of Participants|||Number
803367|NCT00992394|Secondary|Patient Psoriasis Satisfaction Questionnaire (PSSQ): Depression, at Baseline, Before Retreatment, and at the End of Retreatment|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).|Baseline to Week 52|mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA.||Number of Participants|||Number
803368|NCT00992394|Secondary|Patient Psoriasis Satisfaction Questionnaire (PSSQ): Anxiety, at Baseline, Before Retreatment, and at the End of Retreatment|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).|Baseline to Week 52|mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA.||Number of Participants|||Number
803369|NCT00992394|Secondary|Patient Psoriasis Satisfaction Questionnaire (PSSQ): Your Comfort Level With Your Personal Appearance, at Baseline, Before Retreatment, and at the End of Retreatment|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).|Baseline to Week 52|mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA.||Number of Participants|||Number
803370|NCT00992394|Secondary|Patient Psoriasis Satisfaction Questionnaire (PSSQ): Joint Pain, at Baseline, Before Retreatment, and at the End of Retreatment|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).|Baseline to Week 52|mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA.||Number of Participants|||Number
803371|NCT00992394|Secondary|Patient Psoriasis Satisfaction Questionnaire (PSSQ): Skin Pain, at Baseline, Before Retreatment, and at the End of Retreatment|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).|Baseline to Week 52|mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA.||Number of Participants|||Number
812466|NCT01070784|Primary|Clinical Laboratory Test: Haematology -Neutrophils|Change from baseline|Baseline and 52 week after|||percentage of Neutrophils||Standard Deviation|Mean
803372|NCT00992394|Secondary|Patient Psoriasis Satisfaction Questionnaire (PSSQ): Burning Sensation in the Skin, at Baseline, Before Retreatment, and at the End of Retreatment|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).|Baseline to Week 52|mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA.||Number of Participants|||Number
803373|NCT00992394|Secondary|Patient Psoriasis Satisfaction Questionnaire (PSSQ): Bleeding of the Skin, at Baseline, Before Retreatment, and at the End of Retreatment|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).|Baseline to Week 52|mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA.||Number of Participants|||Number
803374|NCT00992394|Secondary|Patient Psoriasis Satisfaction Questionnaire (PSSQ): Tightness of the Skin, at Baseline, Before Retreatment, and at the End of Retreatment|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).|Baseline to Week 52|mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA.||Number of Participants|||Number
803375|NCT00992394|Secondary|Patient Psoriasis Satisfaction Questionnaire (PSSQ): Redness of the Skin, at Baseline, Before Retreatment, and at the End of Retreatment|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).|Baseline to Week 52|mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA.||Number of Participants|||Number
803376|NCT00992394|Secondary|Patient Psoriasis Satisfaction Questionnaire (PSSQ): Flaking Skin, at Baseline, Before Retreatment, and at the End of Retreatment|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).|Baseline to Week 52|mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA.||Number of Participants|||Number
803377|NCT00992394|Secondary|Patient Psoriasis Satisfaction Questionnaire (PSSQ): The Overall Appearance of Skin, at Baseline, Before Retreatment, and at the End of Retreatment|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).|Baseline to Week 52|mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA.||Number of participants|||Number
803378|NCT00992394|Secondary|Time-Normalized Area Under Curve (AUC) of Dermatology Life Quality Index (DLQI) at Week 52|DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst).|Week 52|The modified intent-to-treat (mITT) population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA.||Units on a scale||Standard Deviation|Mean
803379|NCT00992394|Primary|Time-Normalized Area Under Curve (AUC) of Physician Global Assessment (PGA) of Psoriasis Score at Week 52|PGA psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration and scaling across all psoriatic lesions. PGA of Psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). ‘Clear’ and “Almost clear’ includes all participants who were scored as a 0 or 1. For participants who discontinued the study before week 52, the final PGA score was carried forward to the remaining time points before calculating the 52-week AUC. The AUC was calculated on the PGA score profile with the method of trapeziums from baseline visit to visit 52. The time-normalized AUC is defined as the ratio between AUC and the expected treatment period (days): AUC/ 52 weeks*7days + 1.|Week 52|The modified intent-to-treat (mITT) population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA. Last Observation Carried Forward (LOCF).||Units on a scale||Standard Deviation|Mean
803380|NCT00992407|Secondary|Change From Baseline in Barnes Akathisia Rating Scale (BARS) Score at Week 52|The BARS includes an objective rating, 2 subjective ratings of symptoms of akathisia (awareness of restlessness and reported distress related to restlessness: ranging from 0 to 3), and a global clinical rating of akathisia (GCRA), ranging from 0 (absent) to 5 (severe). The global rating score, that is scored separately, is the most relevant measure of severity of akathisia. Higher scores denote worsening akathisia.|Baseline and Week 52|"Safety analysis population included all randomized subjects who received risperidone injection or risperidone tablets at least once. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."||Units on a scale||Standard Deviation|Mean
803405|NCT00992433|Primary|Number of Participants Reporting Solicited Subjective Local Reactions After the Second Vaccination|Participants maintained a memory aid to record daily the occurrence of local symptoms of pain, tenderness and swelling for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Within 8 days post second vaccination (Day 0-7).|Participants who received the second vaccination are included. Analyses are as treated.||Participants|||Number
803381|NCT00992407|Secondary|Change From Baseline in Simpson and Angus Rating Scale (SAS) Score at Week 52|The SAS rates 10 items from 0 (normal) to 4 (extreme), including gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, leg pendulousness, head rotation, Glabellar tap, tremor and salivation. The SAS global score is the average score (total sum of items score divided by the number of items) and ranges between 0 and 4, where the higher score denotes more severe condition of extra pyramidal symptoms.|Baseline and Week 52|"Safety analysis population included all randomized subjects who received risperidone injection or risperidone tablets at least once. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."||units on a scale||Full Range|Median
803382|NCT00992407|Secondary|Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Score at Week 52|The AIMS rates the severity of involuntary movements from 0 (none) to 4 (severe), including facial and oral movements, extremity movements, trunk movements, global and judgments, and 2 additional items concerning dental status (yes/no). A total score (ranging from 0 to 28) will be calculated as the sum of items 1 to 7.|Baseline and Week 52|"Safety analysis population included all randomized subjects who received risperidone injection or risperidone tablets at least once. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."||units on a scale||Full Range|Median
803383|NCT00992407|Secondary|Change From Baseline in Number of Outpatient Clinic Visits at Week 52|Healthcare economics questionnaire consists of 13-Questions, which measured disease burden on participant; out of which 1 question is related to number of outpatient clinic visits. Mean-calculations were done for all questions. Higher value indicates more disease burden. Change from Baseline is the value at Week 52 minus value at Baseline.|Baseline and Week 52|"ITT population included all randomized participants who received at least one dose of study medication & fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure.n signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively."||number of visits||Standard Deviation|Mean
803384|NCT00992407|Secondary|Change From Baseline in Travelling Fee for Outpatients, Hospitalization Travelling Fee and Salary Paid a Participant Before Being Ill at Week 52|Healthcare economics questionnaire consists of 13-Questions, which measured disease burden on participant; out of which 3 questions are related to travelling fee for outpatients, hospitalization travelling fee and salary paid a participant before being ill. Mean-calculations were done for all questions. Travelling fee, hospitalization travelling fee and salary paid were assessed for every past three months. Higher value indicates more disease burden. Change from Baseline is the value at Week 52 minus value at Baseline.|Baseline and Week 52|"ITT population included all randomized participants who received at least one dose of study medication & fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure.n signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively."||Won||Standard Deviation|Mean
803385|NCT00992407|Secondary|Change From Baseline in Total Outpatients and Inpatients Hours at Week 52|Healthcare economics questionnaire consists of 13-Questions, which measured disease burden on participant; out of which 2 questions are related to total outpatients and inpatients hours. Total outpatients hours and total inpatient hours indicate the total hours spent by outpatients and inpatients respectively at Investigator site.Mean-calculations were done for all questions. Higher value indicates more disease burden. Change from Baseline is the value at Week 52 minus value at Baseline.|Baseline and Week 52|"ITT population included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."||hours||Standard Deviation|Mean
803386|NCT00992407|Secondary|Change From Baseline in Days of Hospitalization, Number of Days Affected by Participants and Family, at Week 52|Healthcare economics questionnaire consists of 13-Questions, which measured disease burden on participant; out of which 3 questions are related to days of hospitalization, number of days affected by participants and family per participant within reporting interval score. Mean-calculations were done for all questions. Change from Baseline is the value at Week 52 minus value at Baseline.|Baseline and Week 52|"ITT population included all randomized participants who received at least one dose of study medication & fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure.n signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively."||days||Standard Deviation|Mean
803387|NCT00992407|Secondary|Change From Baseline in Members for Outpatients, Members Visiting Inpatients, Affected Members and Visiting Inpatients at Week 52|Healthcare economics questionnaire consists of 13-Questions, which measured disease burden on participant; out of which 4 questions are related to number of members for outpatients, number of members visiting inpatients, number of affected members and number of visiting inpatients. Mean-calculations were done for all questions. Higher value indicates more disease burden. Change from Baseline is the value at Week 52 minus value at Baseline.|Baseline and Week 52|"ITT population included all randomized participants who received at least one dose of study medication & fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure.n signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively."||participants||Standard Deviation|Mean
803388|NCT00992407|Secondary|Change From Baseline in Drug Attitude Inventory–10 (DAI-10) Score at Week 52|The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. Score ranges from (-) 10 to 10. It is the binary scale assessing the participant's subjective response. A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive subjective response (SR); a negative sum of scores indicates a negative SR (non-compliant).|Baseline and Week 52|"ITT population included all randomized participants who received at least one dose of study medication & fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure.n signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively."||units on a scale||Standard Deviation|Mean
803454|NCT00992602|Secondary|Overall Survival||Time from start of therapy until death, assessed up to 4 years|||months||95% Confidence Interval|Median
812467|NCT01070784|Primary|Clinical Laboratory Test: Haematology -Monocytes|Change from baseline|Baseline and 52 week after|||percentage of Monocytes||Standard Deviation|Mean
803389|NCT00992407|Secondary|Change From Baseline in Scale to Assess Unawareness of Mental Disorder (SUMD) Score at Week 52|The SUMD scale is a semi-structured scale that assesses participant's awareness of and insight into their illness, that is, the present level of insight. SUMD total score ranges from 0-27, with higher scores indicating poorer insight. The scale consists of nine items score ranging from 1 to 3, with higher scores indicating poorer insight. Score for each item is summed to produce the total score.|Baseline and Week 52|"ITT population included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."||units on a scale||Standard Deviation|Mean
803390|NCT00992407|Secondary|Change From Baseline in Global Assessment of Functioning (GAF) Test Score at Week 52|The GAF is a 100-point tool rating overall psychological, social and occupational functioning of adults. The higher score range (91 to 100) refers to a superior functioning in a wide range of activities, and absence of symptoms. The lower score range (1 to 10) refers to persistent danger of severely hurting self or others; or persistent inability to maintain minimum personal hygiene; or serious suicidal act with clear expectation of death.|Baseline and Week 52|"ITT population included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."||units on a scale||Standard Deviation|Mean
803391|NCT00992407|Secondary|Change From Baseline in Psychosocial Well-being Index (PWI) Score at Week 52|Psychosocial Well-being Index (PWI) is a questionnaire about how the participant feels and how the things had been going with them. Total score ranges from 0 to 135, where lower score indicates worsening.|Baseline and Week 52|"ITT population included all randomized participants who received at least one dose of study medication & fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure.n signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively."||units on a scale||Standard Deviation|Mean
803392|NCT00992407|Secondary|Change From Baseline in Theory of Mind (TOM) Scale Score at Week 52|The TOM scale is used to assess the ability of participant to infer other's mental states. It includes recognition that other individuals experience thoughts, feelings, intentions, and desires. It is measured by cartoon task, score ranging from 0-30 and stork task which includes stork task set A (false belief), stork task set B (double bluff, white lie, persuasion, misunderstanding), and physical story, score ranging from 0-12, 0-26 and 0-24 respectively. Higher score indicates improvement.|Baseline and Week 52|"ITT population included all randomized participants who received at least one dose of study medication & fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure.n signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively."||units on a scale||Standard Deviation|Mean
803393|NCT00992407|Secondary|Change From Baseline in Continuous Performance Task (CPT) Based on Neurocognitive Function Test (NCFT) at Week 52|The NCFT is neuropsychological test which measures psychological functions. The CPT assessed CPT (Omissions) and CPT (Commissions). Omission errors indicate the number of times the target was presented, but the participant did not respond/click the mouse. High omission rates indicate that the participant is either not paying attention (distractibility) to stimuli or has a sluggish response. Commission errors indicate the number of times the participant responded but no target was presented. A fast reaction time and high commission error rate points to difficulties with impulsivity. A slow reaction time with high commission and omission errors indicates inattention in general.|Baseline and Week 52|"ITT population included all randomized participants who received at least one dose of study medication & fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure.n signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively."||Errors||Standard Deviation|Mean
803394|NCT00992407|Secondary|Change From Baseline in Working Memory Based on Neurocognitive Function Test (NCFT) at Week 52|The NCFT is neuropsychological test which measures psychological functions. Working memory was assessed using Controlled Oral Word Association Test (COWAT) which measured verbal fluency and is a sub-test of the multilingual aphasia examination. The COWAT uses the three letter set of C, F, and L to assess phonemic fluency. Individuals are given 1 minute to name as many words as possible beginning with one of the letters. The procedure is then repeated for the remaining two letters. More words indicate improvement.|Baseline and Week 52|"ITT population included all randomized participants who received at least one dose of study medication & fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure.n signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively."||Words||Standard Deviation|Mean
803395|NCT00992407|Secondary|Change From Baseline in Trail Making Test Based on Neurocognitive Function Test (NCFT) at Week 52|The NCFT is neuropsychological test which measures psychological functions. The Trail Making Test is composed of two Parts, A and B. Part A consists of 25 circles printed on a sheet of paper. Each circle contains a number from 1 to 25. The participant's task is to connect the circles with a pencil line as quickly as possible, beginning with the number 1 and proceeding in numerical sequence. Part B consists of 25 circles numbered from 1 to 13 and lettered from A to L. The task in Part B is to connect the circles, in sequence, alternating between numbers and letters. Here, mean number of seconds are represented required to complete each Part.|Baseline and Week 52|"ITT population included all randomized participants who received at least one dose of study medication & fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure.n signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively."||Seconds||Standard Deviation|Mean
803404|NCT00992433|Primary|Number of Participants Reporting Solicited Quantitative Local Reactions After the First Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Within 8 days post first vaccination (Day 0-7).|Participants who received the first vaccination are included. Analyses are as treated.||Participants|||Number
812468|NCT01070784|Primary|Clinical Laboratory Test: Haematology -Lymphocytes|Change from baseline|Baseline and 52 week after|||percentage of Lymphocytes||Standard Deviation|Mean
803396|NCT00992407|Secondary|Change From Baseline in Verbal Working Memory (VWM) Response Based on Neurocognitive Function Test (NCFT) at Week 52|The NCFT is neuropsychological test which measures psychological functions. The VWM was measured by Korean-Wechsler Adults Intelligence Scale (K-WAIS), which consists of two subscales, the Verbal scale (6 subtests) and the Performance scale (5 subtests). The verbal tests were: information, comprehension, arithmetic, digit span, similarities, and vocabulary. Arithmetic and Digit Span test of Verbal WAIS scales was conducted. Arithmetic test (arithmetic questions were asked orally) involved calculations that measured concentration while manipulating mental mathematical problems. Digit span test (children were asked to repeat the orally given sequences of numbers either as heard or in reverse order) measured attention, concentration, and mental control. Here, mean number of correct responses in limited time period are reported for arithmetic (calculation) and Digit span. Increase in number of correct response indicates improvement.|Baseline and Week 52|"ITT population included all randomized participants who received at least one dose of study medication & fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure.n signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively."||Correct responses||Standard Deviation|Mean
803397|NCT00992407|Secondary|Change From Baseline in Emotional & Social Functioning Scale (SFS) Score at Week 52|For emotional and SFS, mean scores of neuroticism-extroversion-openness (NEO) personality test, relationship style questionnaire (RSQ), state-trait anger expression inventory (STAXI), positive affect and negative affect schedule (PANAS), emotional intelligence (EI), beck depression inventory (BDI), and beck anxiety inventory (BAI) scales were calculated. Score ranges for each category as:60-300 for NEO, 30-150 for RSQ, 20-80 for STAXI, 20-100 for PANAS, 8-172 for EI, 0-63 for BDI and BAI. Higher score indicates improvement.|Baseline and Week 52|"ITT population included all randomized participants who received at least one dose of study medication & fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure.n signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively."||units on a scale||Standard Deviation|Mean
803398|NCT00992407|Secondary|Change From Baseline in Social Functioning Scale (SFS) Score at Week 52|Social Functioning Scale (SFS) scores from 0 to 223 wherein, following categories were involved: Social Engagement (Score Range 0-15); Interpersonal Communication (Score Range 0-9); Recreational Activities (Score Range 0-45); Social Activities (Score Range 0-66; Independence Competence (Score Range 0-39); Independence Performance (Score Range 0-39); Occupational Activity (Score Range 0-10). Total score is sum of all sub scores and higher score indicates better level of social functioning.|Baseline and Week 52|"ITT population included all randomized participants who received at least one dose of study medication & fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure.n signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively."||units on a scale||Standard Deviation|Mean
803399|NCT00992407|Secondary|Change From Baseline in Clinical Global Impression-Severity Scale (CGI-S) Score at Week 52|"The CGI rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher scores indicate worsening."|Baseline and Week 52|ITT population included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria.||units on a scale||Standard Deviation|Mean
803400|NCT00992407|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Score at Week 52|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Baseline and Week 52|ITT population included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria.||units on a scale||Standard Deviation|Mean
803401|NCT00992407|Primary|Change From Baseline in Personal and Social Performance (PSP) Scale Score at Week 52|The PSP assesses degree of participant’s dysfunction within 4 domains of behavior, socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate degree of difficulty (1=absent to 6=very severe) in each of 4 domains. Based on the 4 domains there will be one total score. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision.|Baseline and Week 52|Intent-to-treat (ITT) population included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria.||units on a scale||Standard Deviation|Mean
803402|NCT00992433|Primary|Number of Participants Reporting Vaccine-Associated Serious Adverse Events (SAEs)|Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof; resulted in a congenital anomaly/birth defect; may have jeopardized the participant or required intervention to prevent one of these outcomes; or was described as Guillain-Barré Syndrome. Association to vaccination was determined by a study clinician licensed to make medical diagnosis.|Day 0 through Day 180 after the last vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated.||Participants|||Number
803403|NCT00992433|Primary|Number of Participants Reporting Solicited Quantitative Local Reactions After the Second Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Within 8 days post second vaccination (Day 0-7).|Participants who received the second vaccination are included. Analyses are as treated.||Participants|||Number
803455|NCT00992602|Primary|Survival Free of Neurological Progression, Measured in Weeks|Neurological progression defined by either clinical impression (measured by Karnofsky Performance Status), radiographical response (using Macdonald criteria), or cytologic response (measured by CSF cytology).|Time from start of therapy, assessed up to 4 years|||weeks||95% Confidence Interval|Median
803406|NCT00992433|Primary|Number of Participants Reporting Solicited Subjective Local Reactions After the First Vaccination|Participants maintained a memory aid to record daily the occurrence of local symptoms of pain, tenderness and swelling for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Within 8 days post first vaccination (Day 0-7).|Participants who received the first vaccination are included. Analyses are as treated.||Participants|||Number
803407|NCT00992433|Primary|Number of Participants Reporting Fever After the Second Vaccination|Participants were provided a thermometer and a memory aid to record daily oral temperatures for 8 days (Day 0-7) after vaccination. Participants are counted as experiencing fever if they reported oral temperatures of 38 degrees Celsius or higher on any of the 8 days.|Within 8 days post second vaccination (Day 0-7).|Participants who received the second vaccination are included. Analyses are as treated.||Participants|||Number
803408|NCT00992433|Primary|Number of Participants Reporting Fever After the First Vaccination|Participants were provided a thermometer and a memory aid to record daily oral temperatures for 8 days (Day 0-7) after vaccination. Participants are counted as experiencing fever if they reported oral temperatures of 38 degrees Celsius or higher on any of the 8 days.|Within 8 days post first vaccination (Day 0-7).|Participants who received the first vaccination are included. One participant did not record temperatures. Analyses are as treated.||Participants|||Number
803409|NCT00992433|Primary|Number of Participants Reporting Solicited Subjective Systemic Reactions After the Second Vaccination|Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Within 8 days post second vaccination (Day 0-7).|Participants who received the second vaccination are included. Analyses are as treated.||Participants|||Number
803410|NCT00992433|Primary|Number of Participants Reporting Solicited Subjective Systemic Reactions After the First Vaccination|Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Within 8 days post first vaccination (Day 0-7).|Participants who received the first vaccination are included. Analyses are as treated.||Participants|||Number
803411|NCT00992433|Primary|Number of Participants in the CD4 200/mL or Greater Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 180 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 180 after the second vaccination|Participants who received both H1N1 vaccinations in window and from whom blood was collected at the timepoint are included. Analyses are as treated. This outcome restricts to CD4 stratum.||Participants|||Number
803412|NCT00992433|Primary|Number of Participants in the CD4 200/mL or Greater Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 10 and 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 10 and 21 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 10 and Day 21 after the second vaccination|Participants who received both H1N1 vaccinations in window and from whom blood was collected at the timepoint are included. Analyses are as treated. This outcome restricts to CD4 stratum.||Participants|||Number
803413|NCT00992433|Primary|Number of Participants in the CD4 200/mL or Greater Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from all participants 21 days after the first vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the first vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint are included. Analyses are as treated. This outcome restricts to CD4 stratum.||Participants|||Number
803414|NCT00992433|Primary|Number of Participants in the CD4 200/mL or Greater Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 10 Days Following the First Dose of H1N1 Vaccine|Blood was collected from all participants 10 days after the first vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 10 after the first vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint are included. Analyses are as treated. This outcome restricts to CD4 stratum.||Participants|||Number
803415|NCT00992433|Primary|Number of Participants in the CD4 200/mL or Greater Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus at Baseline Prior to the First Dose of H1N1 Vaccine|Blood was collected from all participants at Day 0 prior to the first vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 0 prior to the first vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint are included. Analyses are as treated. This outcome restricts to CD4 stratum.||Participants|||Number
803595|NCT00993473|Secondary|Glycosylated Hemoglobin A1c (HbA1c): End of Treatment and Change From Baseline to End of Treatment||baseline, 6 months|Same as for primary endpoint: mITT population. However post-baseline HbA1c values were missing for 9 patients: 2 patients in the Lantus group and 7 in the NPH group.||percent HbA1c||Standard Deviation|Mean
803416|NCT00992433|Primary|Number of Participants in the CD4 Less Than 200/mL Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 180 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 180 after the second vaccination|Participants who received both H1N1 vaccinations in window and from whom blood was collected at the timepoint are included. One participant was excluded due to not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 stratum.||Participants|||Number
803417|NCT00992433|Primary|Number of Participants in the CD4 Less Than 200/mL Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 21 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the second vaccination|Participants who received both H1N1 vaccinations in window and from whom blood was collected at the timepoint are included. One participant was excluded due to not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 stratum.||Participants|||Number
803418|NCT00992433|Primary|Number of Participants in the CD4 Less Than 200/mL Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 10 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 10 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 10 after the second vaccination|Participants who received both H1N1 vaccinations in window and from whom blood was collected at the timepoint are included. One participant was excluded due to not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 stratum.||Participants|||Number
803419|NCT00992433|Primary|Number of Participants in the CD4 Less Than 200/mL Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from all participants 21 days after the first vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the first vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint are included. One participant was excluded due to not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 stratum.||Participants|||Number
803420|NCT00992433|Primary|Number of Participants in the CD4 Less Than 200/mL Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus at Baseline and 10 Days Following the First Dose of H1N1 Vaccine|Blood was collected from all participants at Day 0 prior to vaccination and 10 days after the first vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 0 prior to vaccination and 10 days after the first vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint are included. One participant was excluded due to not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 stratum.||Participants|||Number
803421|NCT00992433|Primary|Number of Participants in the CD4 200/mL or Greater Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 180 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 180 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 180 days after the second vaccination|Participants who received both H1N1 vaccinations in window and from whom blood was collected at the timepoint are included. One participant was excluded due to not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 stratum.||Participants|||Number
803422|NCT00992433|Primary|Number of Participants in the CD4 200/mL or Greater Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 21 days after the second vaccination|Participants who received both H1N1 vaccinations in window and from whom blood was collected at the timepoint are included. One participant was excluded due to not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 stratum.||Participants|||Number
803466|NCT00992719|Primary|Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery|Participants were contacted after delivery, and medical records reviewed, to collect complications experienced during pregnancy, labor and delivery. The data collection process followed a prospectively-defined list of complications reported for this outcome measure, some of which may have also been reported as serious adverse events if otherwise meeting those requirements.|At time of delivery|All participants from whom outcome data were collected are included in the ITT safety population for this outcome measure.||participants|||Number
803423|NCT00992433|Primary|Number of Participants in the CD4 200/mL or Greater Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 10 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 10 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 10 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 10 days after the second vaccination|Participants who received both H1N1 vaccinations in window and from whom blood was collected at the timepoint are included. Analyses are as treated. This outcome restricts to CD4 stratum.||Participants|||Number
803424|NCT00992433|Primary|Number of Participants in the CD4 CD4 200/mL or Greater Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 21 days after the first vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint are included. Analyses are as treated. This outcome restricts to CD4 stratum.||Participants|||Number
803425|NCT00992433|Primary|Number of Participants in the CD4 200/mL or Greater Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 10 Days Following the First Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 10 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 10 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 10 days after the first vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint are included. Analyses are as treated. This outcome restricts to CD4 stratum.||Participants|||Number
803426|NCT00992433|Primary|Number of Participants in the CD4 Less Than 200/mL Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 180 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 180 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 180 days after the second vaccination|Participants who received both H1N1 vaccinations in window and from whom blood was collected at the timepoint are included. One participant was excluded due to not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 stratum.||Participants|||Number
803427|NCT00992433|Primary|Number of Participants in the CD4 Less Than 200/mL Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 21 days after the second vaccination|Participants who received both H1N1 vaccinations in window and from whom blood was collected at the timepoint are included. One participant was excluded due to not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 stratum.||Participants|||Number
803428|NCT00992433|Primary|Number of Participants in the CD4 Less Than 200/mL Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 10 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 10 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 10 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 10 days after the second vaccination|Participants who received both H1N1 vaccinations in window and from whom blood was collected at the timepoint are included. One participant was excluded due to not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 stratum.||Participants|||Number
803429|NCT00992433|Primary|Number of Participants in the CD4 Less Than 200/mL Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 21 days after the first vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint are included. One participant was excluded due to not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 stratum.||Participants|||Number
803535|NCT00993200|Primary|The Number of Days to First International Normalized Ratio (INR) Within Therapeutic Range|The number of days to first International Normalized Ratio (INR) is being measured from initiation of warfarin to the time when a subject first has an INR lab test result within +/- 0.5 of mean target INR range. The period during which this time interval could be measured is any time during the subject's warfarin therapy.|variable as defined|analysis per protocol||days||Standard Deviation|Median
803430|NCT00992433|Primary|Number of Participants in the CD4 Less Than 200/mL Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 10 Days Following the First Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 10 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 10 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 10 days after the first vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint are included. One participant was excluded due to not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 stratum.||Participants|||Number
803431|NCT00992446|Secondary|Event-free Survival|(Not enough follow-up to report. 6/17/2018 is when this outcome measure will be met)|3 Years Post-Transplant||||||
803432|NCT00992446|Secondary|Overall Survival|(Not enough follow-up to report. 6/17/2018 is when this outcome measure will be met)|3 Years Post-Transplant||||||
803433|NCT00992446|Secondary|Ability to Complete Planned 12 Cycles of Maintenance Therapy|Number of patients who completed all 12 cycles of maintenance therapy.|Approximately 12 months following start of maintenance therapy|||Participants|||Count of Participants
803434|NCT00992446|Secondary|Median Time to Disease Progression|(Not enough follow-up to report. 6/17/2018 is when this outcome measure will be met)|3 Years Post-Transplant||||||
803435|NCT00992446|Primary|Toxicity of Vorinostat Bortezomib Maintenance Therapy After Autologous Transplant|Number of patients on maintenance therapy post-transplant who experienced grade 3 or higher toxicity per NCI-Common Terminology Criteria for Adverse Events, version 3. The first three months of bortezomib and vorinostat therapy will be used as the time period to evaluate toxicity for stopping rules of the study. Toxicity that meets stopping rules will be determined based on the number of patients that are withdrawn from study for significant toxicity (grade IV, non-hematological, non-metabolic, non-peripheral neuropathy).|3 months after start of maintenance therapy|||Participants|||Count of Participants
803436|NCT00992459|Secondary|U-PAGN24-hour Excr of NaPBA and HPN-100||24 hours on Day 14 of each treatments|Intent-to-Treat (ITT) (N = 45): Patients receiving any amount of NaPBA or HPN-100 comprise the ITT population. ITT population was to be used for the primary analysis of this secondary endpoint. One subject who withdrew from study after receiving one dose of NaPBA yielding N=44||μg||Standard Deviation|Mean
803437|NCT00992459|Secondary|Cmax PAGN of NaPBA and HPN-100 in Plasma|Blood samples were collected at pre-dose, 2, 4, 8, 12, 16, 20 and 24 hours after first dose on days 14 and 28.|pre-dose, 2, 4, 8, 12, 16, 20 and 24 hours after first dose on days 14 and 28|Intent-to-Treat (ITT) (N = 45): Patients receiving any amount of NaPBA or HPN-100 comprise the ITT population. ITT population was to be used for the primary analysis of this secondary endpoint. One subject who withdrew from study after receiving one dose of NaPBA yielding N=44||μg/mL||Standard Deviation|Mean
803438|NCT00992459|Secondary|Cmax for PBA of NaPBA and HPN-100 in Plasma|Blood samples were collected at pre-dose, 2, 4, 8, 12, 16, 20 and 24 hours after first dose on days 14 and 28.|pre-dose, 2, 4, 8, 12, 16, 20 and 24 hours after first dose on days 14 and 28|Intent-to-Treat (ITT) (N = 45): Patients receiving any amount of NaPBA or HPN-100 comprise the ITT population. ITT population was to be used for the primary analysis of this secondary endpoint. One subject who withdrew from study after receiving one dose of NaPBA yielding N=44||μg/mL||Standard Deviation|Mean
803439|NCT00992459|Secondary|Cmax for PAA of NaPBA and HPN-100 in Plasma|Blood samples were collected at pre-dose, 2, 4, 8, 12, 16, 20 and 24 hours after first dose on days 14 and 28.|pre-dose, 2, 4, 8, 12, 16, 20 and 24 hours after first dose on days 14 and 28|Intent-to-Treat (ITT) (N = 45): Patients receiving any amount of NaPBA or HPN-100 comprise the ITT population. ITT population was to be used for the primary analysis of this secondary endpoint. One subject who withdrew from study after receiving one dose of NaPBA yielding N=44||μg/mL||Standard Deviation|Mean
803440|NCT00992459|Secondary|Rate of Adverse Events in Each Treatment Group||29 Days|Safety population: (N=45 for NaPBA; N = 44 for HPN): Patients receiving any amount of NaPBA or HPN-100 comprise the Safety population. Safety population was to be used for safety analysis performed.||participants|||Number
803441|NCT00992459|Secondary|Number and Severity of Symptomatic Hyperammonemic Crises|Severity of symptomatic hyperammonemic crises was measured by peak ammonia level (µmol/L) when it is >= 100 µmol/L.|29 Days|Safety population: (N=45 for NaPBA; N = 44 for HPN): Patients receiving any amount of NaPBA or HPN-100 comprise the Safety population. Safety population was to be used for safety analysis performed.||events|||Number
803442|NCT00992459|Secondary|Rate (Percentage) of Ammonia Values Above Upper Limit of Normal (ULN) on NaPBA Versus HPN-100|NaPBA treated arm: total 345 blood samples were collected. HPN-100 treated arm: 343 blood samples were collected.|on Day 14 and Day 28|Intent-to-Treat (ITT) (N = 45): Patients receiving any amount of NaPBA or HPN-100 comprise the ITT population. ITT population was to be used for the primary analysis of this secondary endpoint. One subject who withdrew from study after receiving one dose of NaPBA yielding N=44||samples|blood samples||Number
803443|NCT00992459|Secondary|Maximum Ammonia Values Observed on NaPBA Versus HPN-100|Blood samples were collected at pre-dose, 2, 4, 8, 12, 16, 20 and 24 hours after first dose on days 14 and 28.|pre-dose, 2, 4, 8, 12, 16, 20 and 24 hours after first dose on days 14 and 28|Intent-to-Treat (ITT) (N = 45): Patients receiving any amount of NaPBA or HPN-100 comprise the ITT population. ITT population was to be used for the primary analysis of this endpoint. One subject who withdrew from study after receiving one dose of NaPBA yielding N=44||µmol/L||Standard Deviation|Mean
803444|NCT00992459|Secondary|Correlation Between Urinary Phenylacetylglutamine (PAGN) Excretion Over 24 Hours (U-PAGN24-hour Excr) and Venous Ammonia - Area Under the Concentration-time Curve From Time 0 (Predose) to 24 Hours (AUC0-24)|The correlation between 24-hour urinary phenylacetylglutamine (PAGN) excretion (U-PAGN24-hour Excr) and venous ammonia AUC0-24 was summarized and the correlation was tested using the Spearman rank-order correlation.|28 Days|Intent-to-Treat (ITT) (N = 45): Patients receiving any amount of NaPBA or HPN-100 comprise the ITT population. ITT population was to be used for the primary analysis of this secondary endpoint. One subject who withdrew from study after receiving one dose of NaPBA yielding N=44||correlation coefficient|||Number
808123|NCT01020123|Secondary|Diastolic Blood Pressure, Change From Baseline|Summary statistic of change from baseline|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 240 in CSR)||mmHg||Standard Deviation|Mean
803445|NCT00992459|Primary|The Primary Endpoint Was the 24-hour Area Under the Curve for Blood Ammonia (NH324-hour AUC) on Days 14 and 28.|Blood samples were collected at pre-dose, 2, 4, 8, 12, 16, 20 and 24 hours after first dose on days 14 and 28. Arm A day 14 and Arm B day 28 data were combined as a NaPBA treatment Arm. Arm B day 14 and Arm A day 28 data were combined as a HPN-100 treatment Arm.|pre-dose, 2, 4, 8, 12, 16, 20 and 24 hours after first dose on days 14 and 28|Intent-to-Treat (ITT) (N = 45): Patients receiving any amount of NaPBA or HPN-100 comprise the ITT population. ITT population was to be used for the primary analysis of this endpoint. One subject who withdrew from study after receiving one dose of NaPBA yielding N=44||μmol∙h/L||Standard Deviation|Mean
803446|NCT00992589|Primary|Change From Baseline in in Weekly Average I-GERQ-DD Total Score (Double-blind Phase/ Baseline Observation Carried Forward)|The Infant Gastroesophageal Reflux Questionnaire-Daily Diary (I-GERQ-DD) is a 9-item daily diary that the primary caregiver will be instructed to complete every evening at the same time interval after the participant has gone to sleep for the night. The I-GERQ-DD contains 3 subscales: the Regurgitation subscale, the Eating Behavior subscale and the Discomfort subscale. Each of the 9 items will be assigned a numeric score. The total score will be calculated as the sum of all 9 items, and ranges from 0 to 37. A higher value indicates a worse outcome.|Baseline, Week 8|Intent to Treat population, which consisted of all participants who completed the Open-label period, were randomly assigned to treatment in the Double-blind (DB) period, had taken at least 1 dose of DB study drug, and with evaluable data at each measurement time point.||scores on a scale||Standard Deviation|Mean
803447|NCT00992589|Primary|Change From Baseline in I-GERQ-R Total Score (Double-blind Phase/ Baseline Observation Carried Forward)|The Infant Gastroesophageal Reflux Questionnaire-Revised (I-GERQ-R) is a 12-item questionnaire that is completed by the primary caregiver at every office or telephonic visit. It has a weekly recall and the items cover the frequency, amount and discomfort attributed to spit-up, refusal or stopping feeding, crying and fussing, hiccups, arching back and stopping breathing or changing color. The total score is calculated as the sum of all 12 scores for the individual questions, and ranges from 0 to 42. A higher value indicates a worse outcome.|Baseline, Week 8|Intent to Treat population, which consisted of all participants who completed the Open-label period, were randomly assigned to treatment in the Double-blind (DB) period, had taken at least 1 dose of DB study drug, and with evaluable data at each measurement time point.||scores on a scale||Standard Deviation|Mean
803448|NCT00992589|Secondary|Change From Baseline in Weekly Average I-GERQ-DD Eating Behavior Subscale Score (Double-blind Phase/ Last Observation Carried Forward)|The Infant Gastroesophageal Reflux Questionnaire-Daily Diary (I-GERQ-DD) is a 9-item daily diary that the primary caregiver will be instructed to complete every evening at the same time interval after the subject has gone to sleep for the night. The I-GERQ-DD contains 3 subscales: the Regurgitation subscale, the Eating Behavior subscale and the Discomfort subscale. The Eating Behavior subscale score will be calculated as the sum of the 3 questions regarding eating behavior (Questions 4, 5, 6) and will range from 0 to 12. For each subscale score, a higher value indicates a worse outcome.|Baseline, Week 8|Intent to Treat population, which consisted of all participants who completed the Open-label period, were randomly assigned to treatment in the Double-blind (DB) period, had taken at least 1 dose of DB study drug, and with evaluable data at each measurement time point.||scores on a scale||Standard Deviation|Mean
803449|NCT00992589|Secondary|Change From Baseline in Weekly Average I-GERQ-DD Discomfort Subscale Score (Double-blind Phase/ Last Observation Carried Forward)|The Infant Gastroesophageal Reflux Questionnaire-Daily Diary (I-GERQ-DD) is a 9-item daily diary that the primary caregiver will be instructed to complete every evening at the same time interval after the subject has gone to sleep for the night. The I-GERQ-DD contains 3 subscales: the Regurgitation subscale, the Eating Behavior subscale and the Discomfort subscale. The Discomfort subscale score will be calculated as the sum of the 3 questions regarding discomfort (Questions, 7, 8, 9) and will range from 0 to 12. For each subscale score, a higher value indicates a worse outcome.|Baseline, Week 8|Intent to Treat population, which consisted of all participants who completed the Open-label period, were randomly assigned to treatment in the Double-blind (DB) period, had taken at least 1 dose of DB study drug, and with evaluable data at each measurement time point.||scores on a scale||Standard Deviation|Mean
803450|NCT00992589|Secondary|Change From Baseline in Weekly Average I-GERQ-DD Regurgitation Subscale Score (Double-blind Phase/ Last Observation Carried Forward)|The Infant Gastroesophageal Reflux Questionnaire-Daily Diary (I-GERQ-DD) is a 9-item daily diary that the primary caregiver will be instructed to complete every evening at the same time interval after the participant has gone to sleep for the night. The I-GERQ-DD contains 3 subscales: the Regurgitation subscale, the Eating Behavior subscale and the Discomfort subscale. The Regurgitation subscale will be calculated as the sum of the 3 questions regarding regurgitation (Questions 1, 2, 3) and will range from 0 to 13. For each subscale score, a higher value indicates a worse outcome.|Baseline, Week 8|Intent to Treat population, which consisted of all participants who completed the Open-label period, were randomly assigned to treatment in the Double-blind (DB) period, had taken at least 1 dose of DB study drug, and with evaluable data at each measurement time point.||scores on a scale||Standard Deviation|Mean
803451|NCT00992589|Secondary|The Daily Average Number of Episodes Related to Each Volume of Regurgitation During the Double-blind Treatment Period||Baseline, Week 8|Intent to Treat population, which consisted of all participants who completed the Open-label period, were randomly assigned to treatment in the Double-blind (DB) period, had taken at least 1 dose of DB study drug, and with evaluable data at each measurement time point.||number of episodes||Standard Deviation|Mean
803452|NCT00992589|Primary|Change From Baseline in Weight-for-Age Z-Score (Double-blind Phase/ Baseline Observation Carried Forward)|Body weight was measured with the participant unclothed and before a feeding during each office visit. In the analysis of weight data, weight will be transformed to the weight-for-age Z-score using World Health Organization Child Growth Standards, taking into account the infant’s age and gender (Borghi E, 2006).|Baseline, Week 8|Intent to Treat population, which consisted of all participants who completed the Open-label period, were randomly assigned to treatment in the Double-blind (DB) period, had taken at least 1 dose of DB study drug, and with evaluable data at each measurement time point.||Z-score||Standard Deviation|Mean
803453|NCT00992589|Primary|Change From Baseline in Average Daily Frequency of Regurgitation (Double-blind Phase/ Baseline Observation Carried Forward)||Baseline, Week 8|Intent to Treat population, which consisted of all participants who completed the Open-label period, were randomly assigned to treatment in the Double-blind (DB) period, had taken at least 1 dose of DB study drug, and with evaluable data at each measurement time point.||frequency of Regurgitation||Standard Deviation|Mean
803456|NCT00992719|Primary|Number of Participants With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus Following a Single Dose of H1N1 Vaccine|Blood was collected from all participants prior to and at Day 21 post vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 0 prior to and Day 21 following vaccination|Participants were included in the analyses if they received the vaccination and had blood collected at both timepoints, with 1 participant excluded due to receipt of non-study vaccines. Participants were analyzed as treated.||participants|||Number
803457|NCT00992719|Primary|Number of Participants With 4-fold or Greater Serum Hemagglutination Inhibition (HAI) Antibody Titer Increases Against Influenza H1N1 2009 Virus Following a Single Dose of H1N1 Vaccine|Blood was collected from all participants prior to vaccination as well as 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 post vaccination titer was an increase by 4-fold or more.|Day 0 prior to and Day 21 after the first vaccination|Participants were included in the analyses if they received the vaccination and had blood collected at both timepoints, with 1 participant excluded due to receipt of non-study vaccines. Participants were analyzed as treated.||participants|||Number
803458|NCT00992719|Primary|Number of Participants Reporting Fever After Vaccination|Participants were provided with a thermometer and a memory aid on which to record daily oral temperatures for 8 days after vaccination (Day 0-7). The protocol defined fever as oral temperature of 37.8 degrees Celsius or higher. Participants are counted as experiencing fever if they reported oral temperatures of 37.8 degrees Celsius or higher on any of the 8 days.|Within 8 days (Day 0-7) post vaccination|All participants receiving the vaccination and who reported temperatures are included in the safety cohort. One participant did not report temperatures. Analyses are as treated.||participants|||Number
803459|NCT00992719|Primary|Number of Participants Reporting Solicited Subjective Systemic Reactions After Vaccination|Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Within 8 days post vaccination (Day 0-7)|All participants receiving the vaccination are included in the safety cohort. Analyses are as treated.||participants|||Number
803460|NCT00992719|Secondary|Number of Participants With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer Greater Than or Equal to 40 Against the Novel Influenza H1N1 2009 Virus in Cord Blood|Cord blood was collected at the time of delivery for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|At time of delivery|Pregnant participants were included in the analyses if they had cord blood collected at delivery, with 1 participant excluded due to receipt of non-study vaccine. Participants were analyzed as treated.||participants|||Number
803461|NCT00992719|Secondary|Number of Participants With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer Greater Than or Equal to 40 Against the Novel Influenza H1N1 2009 Virus in the Maternal Blood at the Time of Delivery|Blood was collected from participants at the time of delivery for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|At time of delivery|Pregnant participants were included in the analyses if they had blood collected at delivery, with 1 participant excluded due to receipt of non-study vaccine. Participants were analyzed as treated.||participants|||Number
803462|NCT00992719|Primary|Number of Participants Reporting Solicited Quantitative Local Reactions After Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of redness and swelling for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Within 8 days post vaccination (Day 0-7)|All participants receiving the vaccination are included in the safety cohort. Analyses are as treated.||participants|||Number
803463|NCT00992719|Primary|Number of Participants Reporting Solicited Subjective Local Reactions After Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.|Within 8 days post vaccination (Day 0-7)|All participants receiving the vaccination are included in the safety cohort. Analyses are as treated.||participants|||Number
803464|NCT00992719|Primary|Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)|Serious adverse events included any untoward medical occurrence that resulted in death of the mother, fetus or infant; was life threatening to mother, fetus or infant; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof; was a congenital anomaly/birth defect in fetus or infant; or may have jeopardized the mother, fetus or infant, or required intervention to prevent one of the outcomes, or was described as Guillain-Barré Syndrome. Association was determined by a clinician licensed to diagnose and listed on the site's FDA Form 1572.|Day 0 through Day 180 after vaccination|All participants receiving the vaccination are included in the safety cohort. Analyses are as treated.||participants|||Number
803465|NCT00992719|Primary|Number of Births With Neonatal Complications|Participants were contacted after delivery, and medical records reviewed, to collect neonatal complications. The data collection process followed a prospectively-defined list of complications reported for this outcome measure, some of which may have also been reported as serious adverse events if otherwise meeting those requirements.|At time of delivery|All births are included in this outcome measure. Two participants gave birth to twins and two to triplets, each counted separately.||births|||Number
812469|NCT01070784|Primary|Clinical Laboratory Test: Haematology -Basophils|Change from baseline|Baseline and 52 week after|||percentage of Basophils||Standard Deviation|Mean
803467|NCT00992784|Secondary|The GM Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Day 180|The markers assessed were CD40L, IL-2, TNF-α and IFN-γ and vaccine strains tested included A/Brisbane, A/Uruguay and B/Brisbane antigens.|At Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for cell mediated immunity (CMI) Day 180 in subjects for whom data concerning immunogenicity were available for at least one test, 180 Days after vaccination.||cells per million CD4+ T-cells||Standard Deviation|Geometric Mean
803468|NCT00992784|Secondary|The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strains Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21|The markers assessed were Cluster of Differentiation 40 Ligand (CD40L), interleukin 2 (IL-2), tumour necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ) and vaccine strains tested included A/Brisbane, A/Uruguay and B/Brisbane antigens.|At Day 0 and Day 21|Analysis was performed on According-to-Protocol (ATP) cohort for cell mediated immunity (CMI) Day 21 in subjects for whom data concerning immunogenicity were available for at least one test, 21Days after vaccination.||cells per million CD4+ T-cells||Standard Deviation|Geometric Mean
803469|NCT00992784|Secondary|The Number of Subjects Seroprotected to HI Antibodies at Day 180|A seroprotected subject was defined as a subject with a serum HI titer ≥ 1:40 that usually is accepted as indicating protection.|At Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for humoral immunogenicity Day 180 for whom data concerning immunogenicity at day 180 were available.||subjects|||Number
803470|NCT00992784|Secondary|The Number of Subjects Seroprotected to HI Antibodies at Days 0 and 21|A seroprotected subject was defined as a subject with a serum HI titer ≥ to 1:40 that usually is accepted as indicating protection.|At Day 0 and Day 21|Analysis was performed on According-to-Protocol (ATP) cohort for humoral immunogenicity Day 21 for whom data concerning immunogenicity at day 21 were available.||subjects|||Number
803471|NCT00992784|Secondary|HI Antibody SCF at Day 180|SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0.|At Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for humoral immunogenicity Day 180 for whom data concerning immunogenicity at day 180 were available.||fold increase||95% Confidence Interval|Geometric Mean
803472|NCT00992784|Secondary|HI Antibody Seroconversion Factors (SCF) at Day 21|SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0.|At Day 21|Analysis was performed on According-to-Protocol (ATP) cohort for humoral immunogenicity Day 21 for whom data concerning immunogenicity at day 21 were available.||fold increase||95% Confidence Interval|Geometric Mean
803473|NCT00992784|Secondary|The Number of Subjects Seroconverted to HI Antibodies at Day 180|A seroconverted subject was defined as a subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.|Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for humoral immunogenicity Day 180 for whom data concerning immunogenicity at day 180 were available.||subjects|||Number
803474|NCT00992784|Secondary|The Number of Subjects Seroconverted to HI Antibodies at Day 21|A seroconverted subject was defined as a subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.|Day 21|Analysis was performed on According-to-Protocol (ATP) cohort for humoral immunogenicity Day 21 for whom data concerning immunogenicity at day 21 were available.||subjects|||Number
803475|NCT00992784|Secondary|The Number of Subjects Seropositive to HI Antibodies at Day 180|Seropositivity was defined as antibody titer greater than or equal to the cut-off value i.e ≥ 1:10.|Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for humoral immunogenicity Day 180 for whom data concerning immunogenicity at day 180 were available.||subjects|||Number
803476|NCT00992784|Secondary|The Number of Subjects Seropositive to HI Antibodies at Days 0 and 21|Seropositivity was defined as antibody titer greater than or equal to the cut-off value i.e ≥ 1:10.|Day 0 and Day 21|Analysis was performed on According-to-Protocol (ATP) cohort for humoral immunogenicity Day 21 for whom data concerning immunogenicity at day 21 were available.||subjects|||Number
803477|NCT00992784|Secondary|HI Antibody Titers at Day 180|Antibody titers were expressed as GMTs against separate vaccine strains. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for humoral immunogenicity Day 180 for whom data concerning immunogenicity at day 180 were available.||titer||95% Confidence Interval|Geometric Mean
803478|NCT00992784|Secondary|Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21|Antibody titers were expressed as Geometric mean titers (GMTs) against separate vaccine strains. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|Day 0 and Day 21|Analysis was performed on According-to-Protocol (ATP) cohort for humoral immunogenicity Day 21 for whom data concerning immunogenicity at day 21 were available.||titer||95% Confidence Interval|Geometric Mean
803479|NCT00992784|Primary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) After Day 180|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade and related was event assessed by the investigator as causally related to the study vaccination.|After Day 180|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
803480|NCT00992784|Primary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) up to Day 180|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade and related was event assessed by the investigator as causally related to the study vaccination.|Up to Day 180|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
804170|NCT00996892|Secondary|Tmax of Pictilisib on Cycle 1 Day 18 – Stage 1A All Cohorts||Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Median
803481|NCT00992784|Primary|Number of Subjects Reporting AEs of Specific Interest (AESI)|AESI for safety monitoring are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as symptom that prevented normal activity and related was general symptom assessed by the investigator as causally related to the study vaccination.|Day 0-179|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
803482|NCT00992784|Primary|Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit|For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as symptom that prevented normal activity and related was general symptom assessed by the investigator as causally related to the study vaccination.|Day 0-179|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
803483|NCT00992784|Primary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade, grade 3 was unsolicited symptom that prevented normal activity and related was event assessed by the investigator as causally related to the study vaccination.|Day 0-20|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
803484|NCT00992784|Primary|Duration of Solicited General AEs|Duration was defined as number of days with any grade of general symptoms.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.||Days||Full Range|Median
803485|NCT00992784|Primary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs|Any fever was defined as oral temperature ≥ 38.0 degree centigrade (°C), grade 3 fever was oral temperature ≥ 39.0°C-≤ 40.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade, grade 3 was defined as general symptom that prevented normal activity and related was general symptom assessed by the investigator as causally related to the study vaccination.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.||subjects|||Number
803486|NCT00992784|Primary|Duration of Solicited Local AEs|Duration was defined as number of days with any grade of local symptoms.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented on subjects who experienced the symptom.||Days||Full Range|Median
803487|NCT00992784|Primary|Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)|Grade 3 ecchymosis, redness and swelling was ≥ 100 millimeter (mm) and grade 3 pain was considerable pain at rest, that prevented normal everyday activities.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.||subjects|||Number
803488|NCT00992836|Secondary|Cell-mediated Immune Responses to Influenza Viruses Contained in TIV and Other Antigens|"The TIV assay was not performed due to lack of available cells after completion of other planned assays.
The median and interquartile range (IQR) of T-Cell ELISPOT-measured pH1N1 Granzyme B spot-forming cells (SFC)/10^6 peripheral blood mononucleated cell (PBMC).
The median and interquartile range (IQR) of T-Cell ELISPOT-measured PHA INFgamma spot-forming cells (SFC)/10^6 PBMC.
The median and interquartile range (IQR) of T-Cell ELISPOT-measured PHA Granzyme B spot-forming cells (SFC)/10^6 PBMC."|Measured at entry, 21 days after first dose, and 10 days after second dose|The participants who had received all doses of vaccine up to that timepoint and had sufficient samples for testing.||SFC/10^6 PBMC||Inter-Quartile Range|Median
803489|NCT00992836|Secondary|HAI Titers Against Seasonal Influenza Viruses Containing Trivalent Influenza Vaccine (TIV)|Presents the value of the median titer as well as the interquartile range at study entry. Antibodies to seasonal Influenza vaccine were measured using an HAI assay. The potential titer read-outs from the assay used were <10 (considered undetectable), 10, 20, 40, 60, 80, 160, 320, 640, and >=1280.|Measured at entry, 21 days after first dose, and 10 days and 6 months after second dose|The participants who had received all doses of vaccine up to that timepoint and had sufficient samples for testing.||titer||Inter-Quartile Range|Median
803490|NCT00992836|Secondary|Cell-mediated Immune Responses, Measured by B-cell and T-cell Enzyme-linked Immunosorbent Spot (ELISPOT) Assay Values|The median and interquartile range (IQR) of B-Cell ELISPOT-measured IgG antibody-secreting cells (ASC)/10^6 peripheral blood mononucleated cell (PBMC) and the median and interquartile range (IQR) of T-Cell ELISPOT-measured pH1N1 IFNgamma spot-forming cells (SFC)/10^6 PBMC.|Measured at entry, 21 days after first dose, and 10 days after second dose|The participants who had received all doses of vaccine up to that timepoint and had sufficient samples for testing.||ASC or SFC/10^6 PBMC||Inter-Quartile Range|Median
803491|NCT00992836|Secondary|Geometric Mean Antibody Titers (GMT) HAI|Presents the value of the geometric mean titer at each time point.|Measured after first and second doses and 6 months after second dose|The HAI titers following the first vaccination were summarized for the eligible study participants who received at least one vaccine and had nonmissing HAI data, and the titers following the second vaccination for the eligible study participants who received both doses of vaccine and had nonmissing HAI data.||titers||95% Confidence Interval|Geometric Mean
803492|NCT00992836|Secondary|Percent of Participants With an HAI Titer >=40 at Long-term Follow-up||Measured at 6 months after second dose|The HAI titers were summarized for the eligible study participants who received both doses of vaccine and had nonmissing HAI data.||percentage of participants||95% Confidence Interval|Number
803536|NCT00993265|Secondary|National Institute of Mental Health –Trichotillomania Severity Scale (NIMH-TSS)|The National Institute of Mental Health - Trichotillomania Severity Scale (NIMH-TSS) assesses severity of hair pulling. The NIMH-TSS is a 6 item assessment, with total scores ranging from 0-20. Higher scores indicate greater severity/impairment.|Week 12|||units on a scale||Standard Error|Mean
810708|NCT01048606|Secondary|Physical Capacity: 3 Tests From the Senior Fitness Test (Chair Stand Test, Chair Sit-and-Reach Test, Back Scratch Test) + Handgrip Strength Test (Lafayette Hand Dynamometer, Indiana)||0, 6 and 12 months||||||
803493|NCT00992836|Primary|Percent of Participants With a Hemagglutinin Inhibition (HAI) Titer of >=40|Antibodies to Influenza A (H1N1) 2009 were measured using an HAI assay. The potential titer read-outs from the assay used were <10 (considered undetectable), 10, 20, 40, 60, 80, 160, 320, 640 and >=1280. Seroprotection was defined as having a titer of >=40 following vaccination.|Measured at 21 days after first dose and 10 days after second dose|The HAI titers following the first vaccination were summarized for the eligible study participants who received at least one vaccine and had nonmissing HAI data, and the titers following the second vaccination for the eligible study participants who received both doses of vaccine and had nonmissing HAI data.||percentage of participants||95% Confidence Interval|Number
803494|NCT00992836|Primary|Withholding of Second Vaccine Dose Due to Adverse Reactions Attributed to First Dose||Measured at Day 21|The 154 study participants who received at last one vaccination are included in this analysis.||participants|||Number
803495|NCT00992836|Primary|The Number of Participants Who Had at Least One AE Attributed to the Study Vaccine|Shows the number of participants who experienced any events that were thought to be at least possibly related to study treatment. Adverse Events were graded using the DAIDS Grading Severity of AEs (see Link under More Information), as follows: grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death.|Measured up to 7 months after vaccination|The 154 study participants who received at last one vaccination are included in this analysis.||participants|||Number
803496|NCT00992836|Primary|The Number of Participants Who Had at Least One Adverse Event (AE)|"Shows the number of participants who had at least one adverse event (AE) in each category. The AEs include: abnormal laboratory values, signs and symptoms, or diagnoses; solicited local AEs; and solicited systemic AEs.
Adverse Events were graded using the DAIDS Grading Severity of AEs (see Link under More Information), as follows: grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death."|Measured up to 7 months after vaccination|||participants|||Number
803497|NCT00992927|Secondary|Pain Measured by Visual Analogue Scale (VAS)|"before intervention for all participants
using 10cm horizontal visual analog scale
best: 0cm (no pain)
worst: 10cm (worst pain)"|1 month|||cm||Standard Deviation|Mean
803498|NCT00992927|Primary|Range of Motion (ROM) of the Glenohumeral Joint|"before intervention for all participants
using a goniometer
patient sitting on a stool with the arm at anatomical position
worst: 0 degree
best: 360 degree"|1 month|||degree||Standard Deviation|Mean
803499|NCT00992992|Secondary|Overall Survival|Overall survival is defined as the time from the start of treatment to the date of death from any cause.|Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)|ITT-Exposed Population||Months||95% Confidence Interval|Median
803500|NCT00992992|Secondary|Number of Participants With an Adverse Event of Cytopenia|The effects of iodine I-131 tositumomab on the growth and function of hematopoietic progenitor cells was measured as the number of participants who had cytopenia. An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)|ITT-Exposed Population||Participants|||Number
803501|NCT00992992|Secondary|Number of Participants Negative for Human Anti-Murine (Mouse) Antibody (HAMA) at Screening Who Converted to HAMA Positivity or Remained Negative During the Course of the Study|The number of participants who developed human anti-murine (mouse) anibodies (HAMA) after treatment was measured. Conversion to HAMA positivity is relative to Screening (participants were evaluable for HAMA analysis if they were HAMA negative at Screening).|Screening; at Week 7, Week 13, then every 6 months until disease progression or death (up to 143 months)|ITT-Exposed Population. Only those participants evaluable for HAMA were analyzed.||Participants|||Number
803502|NCT00992992|Secondary|Time to Recovery From the Indicated Hematology Parameters|Hematology parameters include ANC (calculated), hemoglobin, platelet count, and WBC count. Nadir is defined as the lowest laboratory value recorded following the administration of study medication. Time to recovery to Baseline for the indicated hematologic parameters is defined as the time required for recovery from nadir values to Baseline values.|Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)|ITT-Exposed Population. Only 24 participants had data available.||Days||95% Confidence Interval|Median
803503|NCT00992992|Secondary|Time to Nadir for the Indicated Hematology Parameters|Hematology parameters include ANC (calculated), hemoglobin, platelet count, and WBC count. Nadir is defined as the lowest laboratory value recorded following the administration of study medication. Time to nadir is defined as the time from Baseline to the time the lowest value recorded following the therapeutic dose.|Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)|ITT-Exposed Population. Only 24 participants had data available.||Days||Standard Deviation|Mean
803504|NCT00992992|Secondary|Mean Nadir Values for Platelets and White Blood Cell (WBC) Count|Nadir is defined as the lowest laboratory value recorded following the administration of study medication. Platelets and WBCs are types of blood cells.|Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)|ITT-Exposed Population. Only 24 participants had platelet and WBC data available.||1000 cells/microliter||Standard Deviation|Mean
803505|NCT00992992|Secondary|Mean Nadir Value for Hemoglobin|Nadir is defined as the lowest laboratory value recorded following the administration of study medication. Hemoglobin is the iron-containing oxygen-transport metalloprotein in the red blood cells.|Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)|ITT-Exposed Population. Only 24 participants had hemoglobin data available.||grams/deciliter (g/dL)||Standard Deviation|Mean
803506|NCT00992992|Secondary|Mean Nadir Value for Absolute Neutrophil Count (ANC)|Nadir is defined as the lowest laboratory value recorded following the administration of study medication. ANC is a measure of the number of neutrophil granulocytes present in the blood. Neutrophils are a type of white blood cell that fights infection.|Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)|ITT-Exposed Population. Only 24 participants had ANC data available.||1000 cells/millimeters cubed (mm^3)||Standard Deviation|Mean
803596|NCT00993473|Secondary|Event Rate of Severe Nocturnal Hypoglycemia Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years|Severe nocturnal symptomatic hypoglycemia: any severe symptomatic hypoglycemic event that occurred between 23:00 and 07:00 hours.|6 months|Same as for primary endpoint: mITT population.||number of events per patient-year|Participants|Standard Deviation|Mean
803507|NCT00992992|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAEs are defined as those events that were fatal or immediately life-threatening, and those events that resulted in hospitalization; prolonged an existing hospitalization; resulted in disability; or was a congenital anomaly. Refer to the general AE/SAE module for a complete list of all AEs and SAEs.|Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)|ITT-Exposed Population||Participants|||Number
803508|NCT00992992|Secondary|Time to Treatment Failure|Time to treatment failure is defined as the time from the date of the dosimetric dose to the first occurrence of treatment withdrawal, decision to seek additional therapy, study removal, disease progression, alternative therapy, or death.|Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)|ITT-Exposed Population||Months||95% Confidence Interval|Median
803509|NCT00992992|Secondary|Progression-free Survival|Progression-free survival is defined as the time from the start of treatment (i.e., the dosimetric dose) to the first documented disease progression or death. Disease progression is defined as a >=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must have been greater than 2 centimeters (cm) in diameter by radiographic evaluation or greater than 1 cm in diameter by physical examination.|Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)|ITT-Exposed Population||Months||95% Confidence Interval|Median
803510|NCT00992992|Secondary|Duration of Response for Confirmed Complete Responders|Complete response is the complete disappearance of all detectable clinical and radiographic evidence of disease and the disappearance of all disease-related symptoms. A confirmed response is defined as a response that was confirmed by two separate response evaluations occurring at least 4 weeks apart. Duration of response is defined as the time from the first documented response to the first documented progression.|Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)|ITT-Exposed Population. Only those participants with confirmed CR were analyzed.||Months||95% Confidence Interval|Median
803511|NCT00992992|Secondary|Duration of Response for Unconfirmed Complete Responders|Complete response is defined as the complete disappearance of all detectable clinical and radiographic evidence of disease and the disappearance of all disease-related symptoms. Duration of response is defined as the time from the first documented response to the first documented progression.|Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)|ITT-Exposed Population. Only those participants with unconfirmed CR were analyzed.||Months||95% Confidence Interval|Median
803512|NCT00992992|Secondary|Duration of Response for All Unconfirmed Responders (CR + CRu + PR)|Complete response (CR) is defined as the complete disappearance of all detectable clinical and radiographic evidence of disease and the disappearance of all disease-related symptoms. Complete response unconfirmed is defined as CR, with one of the following: residual lymph node mass >1.5 cm that has regressed by more than 75% in the sum of the product of the diameters or indeterminate bone marrow. Partial response (PR) is defind as a >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions. Duration of response is defined as the time from the first documented response to the first documented progression.|Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)|ITT-Exposed Population. Only those participants with an unconfirmed response (CR, CRu, or PR) were analyzed for duration of response.||Months||95% Confidence Interval|Median
803513|NCT00992992|Secondary|Duration of Response for All Confirmed Responders (CR + CRu + PR)|Complete response (CR) is defined as the complete disappearance of all detectable clinical and radiographic evidence of disease and the disappearance of all disease-related symptoms. Complete response unconfirmed (CRu) is defined as CR, with one of the following: residual lymph node mass >1.5 cm that has regressed by more than 75% in the sum of the product of the diameters or indeterminate bone marrow. Partial response (PR) is defined as a >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions. For participants with CR, CRu, or PR, duration of response is defined as the time from the first documented response to the first documented progression.|Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)|ITT-Exposed Population. Only those participants (par.) with a confirmed CR, CRu, or PR were analyzed. The number of par. analyzed represents the par. with a confimed CR, CRu, or PR who also had the same response or a better response as confirmation (for example, a par. with an initial CRu and a subsequent CR has been included in the analysis).||Months||95% Confidence Interval|Median
803514|NCT00992992|Secondary|Number of Participants With the Indicated Confirmed Response (Confirmed Complete Response, Complete Response Unconfirmed, and Partial Response)|A confirmed response is defined as a response that was confirmed by two separate response evaluations occurring at least 4 weeks apart. Participants with a confirmed response include those with complete response (CR: complete disappearance of all detectable clinical and radiographic evidence of disease and the disappearance of all disease-related symptoms), complete response unconfirmed (CRu: CR, with one of the following: residual lymph node mass >1.5 cm that has regressed by more than 75% in the sum of the product of the diameters or indeterminate bone marrow), or partial response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions). The individual rows for confirmed CR, confirmed CRu, and confirmed PR represent confirmation of the same response. For example, a confirmed CR indicates that a CR was followed by another CR at least 4 weeks later.|Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)|ITT-Exposed Population. Only those participants evaluable for response (those with at least one response assessment) were analyzed.||Participants|||Number
803537|NCT00993265|Secondary|The Milwaukee Inventory for Styles of Trichotillomania–Child Version|"The Milwaukee Inventory for Styles of Trichotillomania (MIST) - Child Version assesses focused pulling, hair pulling that occurs intentionally to relieve tension or distress, and automatic pulling, hair pulling that occurs outside of the child's attention. This scale contains 25 questions, 21 questions in the focused pulling subscale and 4 questions in the automatic pulling subscale. The scores range from 0-36 on the automatic pulling subscale and 0-189 on the focused pulling subscale. Higher scores on the subscales indicate more of the hair pulling is of that style."|Week 12|||units on a scale||Standard Error|Mean
803515|NCT00992992|Primary|Number of Participants With the Indicated Unconfirmed Response (Complete Response, Complete Response Unconfirmed, and Partial Response)|Participants with response include those with complete response (CR: complete disappearance of all detectable clinical and radiographic evidence of disease and the disappearance of all disease-related symptoms), complete response unconfirmed (CRu: CR, with one of the following: residual lymph node mass >1.5 centimeters [cm] that has regressed by more than 75% in the sum of the product of the diameters or indeterminate bone marrow), or partial response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).|Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)|ITT-Exposed Population: all participants who received any iodine I-131 tositumomab or CHOP treatment. Only those participants evaluable for response (those with at least one response assessment) were analyzed.||Participants|||Number
803516|NCT00993044|Primary|Dose Limiting Toxicity|Number of participants with dose limiting toxicity events|2 years|||participants|||Number
803517|NCT00993148|Secondary|Proportion of Participants With Plasma HIV-1 RNA >50 Copies/mL|Proportion of participants with confirmed plasma HIV-1 RNA level >50 copies/mL|96 weeks|||percentage of participants||95% Confidence Interval|Number
803518|NCT00993148|Secondary|Median CD4 Count Change From Baseline|Median changes from baseline in peripheral CD4+ T-cell count|96 weeks|||cells per mm^3||Inter-Quartile Range|Median
803519|NCT00993148|Secondary|Trough Concentrations (Ctrough) of Maraviroc|Average trough concentration (Ctrough) of maraviroc|24 hours|||ng/mL||Standard Deviation|Mean
803520|NCT00993148|Secondary|Drug Adherence, Number of Participants With Missed Doses|Drug adherence, assessed as number of participants with missed doses over four-day recall|Week 24|||participants|||Number
803521|NCT00993148|Secondary|Drug Resistance Mutations and Co-receptor Tropism Assessed by Trofile ES||At study entry and at the time of virologic failure|||participants|||Number
803522|NCT00993148|Secondary|Signs/Symptoms or Laboratory Toxicities of Grade 3 or Higher|Signs/symptoms or laboratory toxicities of Grade 3 or higher, or of any grade which led to a permanent change or discontinuation of study treatment regimen|96 weeks|||participants|||Number
803523|NCT00993148|Secondary|Percentage of Participants With Plasma HIV-1 RNA >50 Copies/mL|Percentage of participants with confirmed plasma HIV-1 RNA level >50 copies/mL|48 weeks|||percentage of participants||95% Confidence Interval|Number
803524|NCT00993148|Secondary|Percentage of Participants With Virologic Failure or Off Study Treatment Regimen|Percentage of participants with virologic failure (confirmed plasma HIV-1 RNA > 50 copies/mL) or off study treatment regimen (composite end point)|24 weeks|||percentage of participants||95% Confidence Interval|Number
803525|NCT00993148|Primary|Percentage of Participants With Plasma HIV-1 RNA >50|Percentage of participants with confirmed plasma HIV-1 RNA > 50 copies/mL|24 weeks|||percentage of participants||95% Confidence Interval|Number
803526|NCT00993187|Secondary|Percentage of Participants With HbA1C < 7.0% at Week 30|HbA1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%).|Week 30|The FAS Population included all randomized participants who had a baseline measurement, consumed at least one dose of study medication, and had at least one post-randomization measurement.||Percentage of Participants|||Number
803527|NCT00993187|Secondary|Change From Baseline in Body Weight at Week 30|Change in body weight following 30 weeks of therapy (i.e., body weight at Week 30 minus body weight at baseline)|Baseline and Week 30|The APaT Population includes all randomized participants who received at least 1 dose of study medication.||kg||95% Confidence Interval|Least Squares Mean
803528|NCT00993187|Secondary|Percentage of Participants With One or More Episodes of Hypoglycemia|Symptomatic episodes assessed as likely to be due to hypoglycemia were reported by investigators as adverse experiences of hypoglycemia. Adverse experiences of hypoglycemia were based on all reports of hypoglycemia; a concurrent glucose measurement was not required.|Up to Week 30|The APaT Population includes all randomized participants who received at least 1 dose of study medication.||Percentage of participants|||Number
803529|NCT00993187|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 30|Blood glucose was measured on a fasting basis (collected after an 8- to 10-hour fast). FPG is expressed as mg/dL. Blood was drawn at predose on Day 1 and after 30 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 30 minus FPG at baseline).|Baseline and Week 30|The FAS Population included all randomized participants who had a baseline measurement, consumed at least one dose of study medication, and had at least one post-randomization measurement.||mg/dL||95% Confidence Interval|Least Squares Mean
803530|NCT00993187|Primary|Number of Participants Who Discontinued Study Drug Due to an Adverse Event|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.|Up to 30 weeks|The APaT Population includes all randomized participants who received at least 1 dose of study medication.||Participants|||Number
803531|NCT00993187|Primary|Number of Participants Who Experienced at Least One Adverse Event (AE)|An adverse event (AE) is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.|Up to 32 weeks|The All Patients as Treated (APaT) Population includes all randomized participants who received at least 1 dose of study medication.||Participants|||Number
803532|NCT00993187|Primary|Change From Baseline in Hemoglobin A1C (HbA1C) at Week 30|HbA1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%). Change in A1C following 30 weeks of therapy (i.e., A1C at Week 30 minus A1C at baseline).|Baseline and Week 30|Full-Analysis-Set (FAS) Population included all randomized participants who had a baseline measurement, consumed at least one dose of study medication, and had at least one post-randomization measurement.||Percent of total hemoglobin||95% Confidence Interval|Least Squares Mean
803533|NCT00993200|Secondary|Thrombotic Complication|Number of thrombotic events|12 week|||number of thrombotic events|||Number
803534|NCT00993200|Secondary|Adverse Major and Minor Bleeding Events|Number of major and minor bleeding events|12 week|||number of bleeding events|||Number
803558|NCT00993421|Secondary|Change in Glycated Hemoglobin A1c (HbA1c) From Baseline|Analysis of change in HbA1c was not conducted due to an inadequate number of samples.|Baseline, 24 weeks|Zero participants were analyzed due to the small sample size.||percent glycated hemoglobin||Standard Deviation|Mean
803538|NCT00993265|Secondary|Trichotillomania Scale for Children - Parent Version|The Trichotillomania Scale for Children (TSC) - Parent Version assesses hair pulling severity, distress, and impairment in children. The scale is split into two sections (severity and distress/impairment), with 12 questions (5 severity and 7 distress/impairment). The severity score is summed from questions 1-5 and divided by 5. The distress/impairment score is summed from questions 6-12 and divided by 7. The total score is calculated by summing the severity score and the distress/impairment score. Scores range from 0-4. Higher total scores indicate greater severity/distress/impairment.|Week 12|||units on a scale||Standard Error|Mean
803539|NCT00993265|Secondary|Children's Depression Inventory|The Massachusetts General Hospital - Hairpulling Scale (MGH-HPS) is a 7-question scale that measures the severity of hair pulling. The scale ranges from 0-28. The higher the score, the more severe the hairpulling.|Week 12|||units on a scale||Standard Error|Mean
803540|NCT00993265|Secondary|Multidimensional Anxiety Scale for Children (MASC)|The Multidimensional Anxiety Scale for Children (MASC) assesses major dimensions of anxiety in children. The MASC contains 39 items rated on a scale of 0-3. Scores range from 0-117. The higher the score, the greater the anxiety.|Week 12|||units on a scale||Standard Error|Mean
803541|NCT00993265|Secondary|Trichotillomania Scale for Children - Child Version|The Trichotillomania Scale for Children (TSC) - Child Version assesses hair pulling severity, distress, and impairment in children. The scale is split into two sections (severity and distress/impairment), with 12 questions (5 severity and 7 distress/impairment). The severity score is summed from questions 1-5 and divided by 5. The distress/impairment score is summed from questions 6-12 and divided by 7. The total score is calculated by summing the severity score and the distress/impairment score. Scores range from 0-4. Higher total scores indicate greater severity/distress/impairment.|Week 12|||units on a scale||Standard Error|Mean
803542|NCT00993265|Primary|Massachusetts General Hospital Hair Pulling Scale (MGH-HPS)|The Massachusetts General Hospital - Hairpulling Scale (MGH-HPS) is a 7-question scale that measures the severity of hair pulling. The scale ranges from 0-28. The higher the score, the more severe the hairpulling.|Week 12|||units on a scale||Standard Error|Mean
803543|NCT00993291|Secondary|Time to Walk 14 Meters|Change in the time to walk 14 meters compared to baseline measured in seconds|5 hours||||||
803544|NCT00993291|Secondary|Gait Velocity|gait velocity measured as change from baseline in in CM/second|5 hours||||||
803545|NCT00993291|Primary|Change in Stride Length From Baseline|Evaluation performed after DBS frequency setting changed for one hour, compared to the subject's baseline DBS frequency stride length|1 hour|||CM||Full Range|Mean
803546|NCT00993317|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)|Range of HAQ-DI score: 0-3 This outcome measures changes of HAQ-DI score at Week 24 from Baseline. Lower score of HAQ-DI represents a better outcome.|Baseline and Week 24|FAS population||scores on a scale||Standard Deviation|Mean
803547|NCT00993317|Secondary|ACR70 Responses at Week24||Week 24|FAS population||participants|||Number
803548|NCT00993317|Secondary|ACR50 Responses at Week 24||Week 24|FAS population||participants|||Number
803549|NCT00993317|Secondary|ACR70 Responses at Week 12|Achieving ACR70 means 70% or greater improvement in the number of tender joints, a 70% or more improvement in the number of swollen joints and a 70% or greater improvement in at least three of the five remaining core set measures: Patient’s and physician’s global assessments, Patient’s assessment of pain, disability index based on the Health Assessment Questionnaire and C-reactive Protein.|Week12|FAS population||participants|||Number
803550|NCT00993317|Secondary|ACR50 Responses at Week 12|Achieving ACR50 means 50% or greater improvement in the number of tender joints, a 50% or more improvement in the number of swollen joints and a 50% or greater improvement in at least three of the five remaining core set measures: Patient’s and physician’s global assessments, Patient’s assessment of pain, disability index based on the Health Assessment Questionnaire and C-reactive Protein.|Week 12|FAS population||participants|||Number
803551|NCT00993317|Secondary|ACR 20 Responses at Week 12|Achieving ACR20 means 20% or greater improvement in the number of tender joints, a 20% or more improvement in the number of swollen joints and a 20% or greater improvement in at least three of the five remaining core set measures: Patient’s and physician’s global assessments, Patient’s assessment of pain, disability index based on the Health Assessment Questionnaire and C-reactive Protein.|Week 12|FAS population||participants|||Number
803552|NCT00993317|Primary|ACR20 Responses at Week 24|Achieving ACR20 means 20% or greater improvement in the number of tender joints, a 20% or more improvement in the number of swollen joints and a 20% or greater improvement in at least three of the five remaining core set measures: Patient’s and physician’s global assessments, Patient’s assessment of pain, disability index based on the Health Assessment Questionnaire and C-reactive Protein.|Week 24|Full Analysis Set (FAS) Population The full set population will consist of all the subjects who were randomized and treated with the drug and received the primary efficacy evaluation at baseline. In the case of dosing administration error, analyses on the FAS population will be conducted according to the drug the subjects were randomized to.||participants|||Number
803553|NCT00993421|Secondary|Pharmacokinetics: Maximum Concentration (Cmax)|Analysis of Cmax was not conducted due to an inadequate number of samples collected.|4 weeks, 12 weeks, and 24 weeks|Zero participants were analyzed due to the small sample size.||nanograms per milliliter (ng/mL)||Standard Error|Geometric Mean
803554|NCT00993421|Secondary|Pharmacokinetics: Area Under the Concentration Time Curve (AUC)|Analysis of AUC was not conducted due to an inadequate number of samples collected.|4 weeks, 12 weeks, and 24 weeks|Zero participants were analyzed because of the low sample size.||nanograms*hour per milliliter (ng*hr/mL)||Standard Error|Geometric Mean
803555|NCT00993421|Secondary|Change in Insulin Resistance From Baseline to 24 Weeks Endpoint|Analysis of change in insulin resistance was not conducted due to an inadequate number of samples.|Baseline, 24 weeks|Zero participants were analyzed due to inadequate number of samples.||Units of Insulin/Day||Standard Deviation|Mean
803556|NCT00993421|Secondary|Change in Fasting Insulin From Baseline to 24 Weeks Endpoint|Analysis of change in fasting insulin was not conducted due to an inadequate number of samples.|Baseline, 24 weeks|Zero participants were analyzed due to an inadequate number of samples.||micro Units/milliliter (μU/mL)||Standard Deviation|Mean
803557|NCT00993421|Secondary|Change in Fasting Glucose From Baseline to 24 Weeks Endpoint|Analysis of change in fasting glucose was not conducted due to an inadequate number of samples.|Baseline, 24 weeks|Zero participants were analyzed due to an inadequate number of samples.||millimoles per Liter (mmol/L)||Standard Deviation|Mean
803559|NCT00993421|Secondary|Change From Baseline in Vitality Scale of Medical Outcomes Short Form - 36 (SF-36) Scale|Vitality change from baseline is presented as Least Squares Mean (LSMean) with treatment, visit, and their interaction as fixed effects, subject as a random effect, baseline body mass index was used as covariate. SF-36 is a self-reported questionnaire that consists of 36 questions covering 8 health domains including vitality. The vitality domain results are presented. The vitality domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning.|Baseline, 24 weeks|Intent to Treat (IIT) population: all randomized participants who received at least one dose of study drug and received the intended study drug. Participants with baseline and at least one post-baseline measurement were included in the analysis (LOCF).||units on a scale||Standard Error|Least Squares Mean
803560|NCT00993421|Secondary|Change From Baseline for Obesity Weight Loss Quality of Life Instrument (OWL-QoL)|Results presented as Least Squares Mean with treatment, visit, and their interaction as fixed effects, subject as random effect, baseline body mass index used as covariate. OWL-QoL consists of 17 items on scale ranging from 0 (Not at all) to 6 (A very great deal). Before calculating scores, each item is reversed. A single quality of life score is computed by summing each item and transforming this raw score onto standardized scale of 0 (greatest impact) to 100 (lowest impact) using formula: score = [(sum of component items score (minus) lowest possible score/ possible raw score range)*100].|Baseline, 24 weeks|ITT||units on a scale||Standard Error|Least Squares Mean
803561|NCT00993421|Secondary|Change in Triglycerides From Baseline to 24 Weeks Endpoint||Baseline, 24 weeks|Intent to Treat (IIT) population: all randomized participants who received at least one dose of study drug and received the intended study drug. Participants with baseline and at least one post-baseline measurement were included in the analysis (LOCF).||millimole/Liter (mmol/L)||Standard Deviation|Mean
803562|NCT00993421|Secondary|Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to 24 Weeks Endpoint||Baseline, 24 weeks|Intent to Treat (IIT) population: all randomized participants who received at least one dose of study drug and received the intended study drug. Participants with baseline and at least one post-baseline measurement were included in the analysis (LOCF).||millimole/Liter (mmol/L)||Standard Deviation|Mean
803563|NCT00993421|Secondary|Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to 24 Weeks Endpoint||Baseline, 24 weeks|Intent to Treat (IIT) population: all randomized participants who received at least one dose of study drug and received the intended study drug. Participants with baseline and at least one post-baseline measurement were included in the analysis (LOCF).||millimole/Liter (mmol/L)||Standard Deviation|Mean
803564|NCT00993421|Secondary|Change in Total Cholesterol From Baseline to 24 Weeks Endpoint||Baseline, 24 weeks|Intent to Treat (IIT) population: all randomized participants who received at least one dose of study drug and received the intended study drug. Participants with baseline and at least one post-baseline measurement were included in the analysis (LOCF).||millimole/Liter (mmol/L)||Standard Deviation|Mean
803565|NCT00993421|Secondary|Percentage Change in Waist Circumference From Baseline to 24 Week Endpoint|Percentage change from baseline to endpoint is presented as LSMEAN with treatment, visit, and their interaction as fixed effects, subject as a random effect, baseline waist circumference, age, gender were used as covariates.|Baseline, 24 weeks|ITT||percent change||Standard Deviation|Least Squares Mean
803566|NCT00993421|Secondary|Change in Waist Circumference From Baseline to 24 Week Endpoint|Change from baseline to endpoint is presented as LSMEAN with treatment, visit, and their interaction as fixed effects, subject as a random effect, baseline waist circumference, age, gender were used as covariates.|Baseline, 24 weeks|ITT population: all randomized participants receiving at least 1 dose of the study drug according to the treatment the participants actually received. Participants with baseline and a measurement at endpoint were included in the analysis.||centimeter (cm)||Standard Error|Least Squares Mean
803567|NCT00993421|Secondary|Change in Body Composition Using Dual Energy X-ray Absorptiometry (DXA) From Baseline to 24 Week Endpoint|Change in body composition (lean body mass and fat mass) was assessed using dual energy x-ray absorptiometry (DXA) and is presented as LSMEAN values with treatment, visit, and their interaction as fixed effects, subject as a random effect, baseline body composition, age, gender were used as covariates.|Baseline, 24 weeks|ITT population: all randomized participants receiving at least 1 dose of the study drug according to the treatment the participants actually received. Participants with baseline and a measurement at endpoint were included in the analysis.||kilograms (kg)||Standard Error|Least Squares Mean
803568|NCT00993421|Secondary|Change in Blood Pressure From Baseline to 24 Week Endpoint|Blood pressure change from baseline is presented as Least Squares Mean (LSMean) with treatment, visit, and their interaction as fixed effects, subject as a random effect, baseline blood pressure, age, gender were used as covariates.|Baseline, 24 weeks|ITT||mm Hg||Standard Error|Least Squares Mean
803569|NCT00993421|Secondary|Change in Heart Rate From Baseline to 24 Week Endpoint|Heart rate change from baseline is presented as Least Squares Mean (LSMean) with treatment, visit, and their interaction as fixed effects, subject as a random effect, baseline heart rate, age, gender were used as covariates.|Baseline, 24 weeks|ITT population: all randomized participants receiving at least 1 dose of the study drug according to the treatment the participants actually received. Participants with baseline and a measurement at endpoint were included in the analysis.||beats per minute (bpm)||Standard Error|Least Squares Mean
803570|NCT00993421|Secondary|Percentage of Participants Who Achieve a Minimum of 10% Weight Loss From Baseline at 24 Weeks||24 weeks|ITT population: all randomized participants receiving at least 1 dose of the study drug according to the treatment the participants actually received. Participants with baseline and a measurement at endpoint were included in the analysis.||percentage of participants|||Number
803571|NCT00993421|Secondary|The Mean Change in Body Weight From Baseline to 24 Week Endpoint|Body weight change from baseline is presented as Least Squares Mean (LSMean) with treatment, visit, and their interaction as fixed effects, subject as a random effect, baseline body weight, age, gender were used as covariates.|Baseline, 24 weeks|ITT population: all randomized participants receiving at least 1 dose of the study drug according to the treatment the participants actually received. Participants with baseline and a measurement at endpoint were included in the analysis.||kilograms||Standard Error|Least Squares Mean
804171|NCT00996892|Secondary|AUC0-24 of Pictilisib on Cycle 1 Day 1 – Stage 1A All Cohorts||Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Days 2|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
803572|NCT00993421|Primary|Percent Change in Body Weight From Baseline to 24 Week Endpoint|Body weight percentage change from baseline is presented as Least Squares Mean (LSMean) with treatment, visit, and their interaction as fixed effects, subject as a random effect, baseline body weight, age, gender were used as covariates.|Baseline, 24 weeks|ITT population: all randomized participants receiving at least 1 dose of the study drug according to the treatment the participants actually received. Participants with baseline and a measurement at endpoint were included in the analysis.||percent change||Standard Error|Least Squares Mean
803573|NCT00993447|Primary|Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine|Solicited Injection-site reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Fever, (Temperature) Headache, Malaise, Myalgia, and Asthenia. Grade 3 Solicited Injection-Site Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥ 5 cm. Grade 3 Solicited Systemic Reactions: Fever, ≥ 39˚C; Headache, Malaise, Myalgia, and Asthenia, Significant; prevents daily activity.|Day 0 up to Day 14 post-each vaccination|Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set, which includes all persons who received at least one dose of study vaccine.||Participants|||Number
803574|NCT00993447|Primary|Summary of Geometric Mean Titer Ratios of Antibodies in Flavivirus-Naive Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine|"Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT).
Flavivirus-naïve participants are defined as those participants with < 10 1/dil for all serotypes with parental dengue virus strains and for Yellow Fever titer. Geometric mean titer ratio is the geometric mean of individual post-vaccination/pre-vaccination titer of antibodies to each parental dengue virus serotype strain."|Day 0 (pre-each vaccination) and Day 28 post-each vaccination|Antibody titers against each dengue virus serotype strain were assessed in the Full Analysis Set.||Titers||95% Confidence Interval|Geometric Mean
803575|NCT00993447|Primary|Summary of Geometric Mean Titers (GMTs) of Antibodies in Flavivirus-Naïve Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine|Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT). Flavivirus-naïve participants are defined as those participants with < 10 1/dilutions for all serotypes with parental dengue virus strains and for Yellow Fever titer.|Day 0 (pre-each vaccination) and Day 28 post-each vaccination|Antibody titers against each dengue virus serotype strain were assessed in the Full Analysis Set.||Titers (1/dilution)||95% Confidence Interval|Geometric Mean
803576|NCT00993447|Primary|Summary of Geometric Mean Titers Ratios of Antibodies in Flavivirus-Immune Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine|Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT). Flavivirus-immune subjects at baseline are defined as those participants with ≥ 10 1/dil for at least one serotype with the parental dengue virus strain or for Yellow Fever titer. Geometric mean titer ratio is the geometric mean of individual post vaccination/pre-vaccination titer of antibodies to each parental dengue virus serotype strain.|Day 0 (pre each vaccination) and Day 28 post each vaccination|Antibody titers against each dengue virus serotype strain were assessed in the Full Analysis Set.||Titers||95% Confidence Interval|Geometric Mean
803577|NCT00993447|Primary|Summary of Geometric Mean Titers (GMTs) of Antibodies in Flavivirus-Immune Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine|Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT). Flavivirus-immune subjects at baseline are defined as those participants with ≥ 10 1/dil for at least one serotype with the parental dengue virus strain or for Yellow Fever titer.|Day 0 (before each vaccination) and Day 28 post each vaccination|Antibody titers against each dengue virus serotype strain were assessed in the Full Analysis Set.||Titers (1/dilution)||95% Confidence Interval|Geometric Mean
803578|NCT00993447|Primary|Summary of Geometric Mean Titers Ratios of Antibodies Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine|Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT). Geometric mean titer ratio is the geometric mean of individual post vaccination/pre vaccination titer of antibodies to each parental dengue virus serotype strain.|Day 0 (before each vaccination) and Day 28 post each vaccination|Antibody titers against each dengue virus serotype strain were assessed in the Full Analysis Set.||Titers||95% Confidence Interval|Geometric Mean
803579|NCT00993447|Primary|Summary of Geometric Mean Titers (GMTs) of Antibodies Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine|Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT).|Day 0 (before each vaccination) and Day 28 post-each vaccination|Antibody titers against each dengue virus serotype strain were assessed in the Full Analysis Set.||Titers (1/dilution)||95% Confidence Interval|Geometric Mean
803580|NCT00993447|Primary|Percentage of Flavi Virus-Naive Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Pre and Post-Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine|Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT).|Day 0 (before each vaccination) and Day 28 post each vaccination|Antibody titers against each dengue virus serotype strain were assessed in the Per Full Analysis Set.||Percentage of participants|||Number
803597|NCT00993473|Secondary|Event Rate of Nocturnal Symptomatic Hypoglycemia Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years|Nocturnal symptomatic hypoglycemia: any symptomatic hypoglycemic event that occurred between 23:00 and 07:00 hours.|6 months|Same as for primary endpoint: mITT population.||number of events per patient-year||Standard Deviation|Mean
803581|NCT00993447|Primary|Percentage of Flavi Virus-Immune Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Pre and Post-Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine|Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT).|Day 0 (before each vaccination) and Day 28 post each vaccination|Antibody titers against each dengue virus serotype strain were assessed in the Per Full Analysis Set.||Percentage of participants|||Number
803582|NCT00993447|Primary|Percentage of Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Before and Following Each Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine|Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT).|Day 0 (before each vaccination) and Day 28 post each vaccination|Antibody titers against each dengue virus serotype strain were assessed in the Per Full Analysis Set.||Percentage of participants|||Number
803583|NCT00993447|Primary|Percentage of Flavi Virus-Naive Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine|Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT). Flavi virus (FV) naïve participants are defined as those participants with < 10 1/dil for all serotypes with parental dengue virus strains and for Yellow Fever titer.|Day 0 (pre-each vaccination) and Day 28 post-each vaccination|Antibody titers against each dengue virus serotype strain were assessed in the Full Analysis Set.||Percentage of participants|||Number
803584|NCT00993447|Primary|Percentage of Flavi Virus-Immune Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine|Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT). Flavi virus (FV) immune participants at baseline are defined as those participants with ≥ 10 1/dil for at least one serotype with the parental dengue virus strain or for Yellow Fever titer.|Day 0 (pre-each vaccination) and Day 28 post-each vaccination|Antibody titers against each dengue virus serotype strain were assessed in the Full Analysis Set.||Percentage of Participants|||Number
803585|NCT00993447|Primary|Percentage of Participants With Antibody Titers of ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine|Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT).|Day 0 (pre-each vaccination) and Day 28 post-each vaccination|Antibody titers against each dengue virus serotype strain were assessed in the Per Protocol Analysis Set.||Percentage of participants|||Number
803586|NCT00993473|Other Pre-specified|Nocturnal Blood Glucose Variability Based on All On-treatment CGMS Values|Calculated for any given patient as the standard deviation (SD) of all CGMS interstitial glucose values recorded during the nocturnal time period (between 23:00 and 07:00 hours).|6 months|The population analyzed consisted of patients from the mITT population (as defined for primary outcome measure) with on-treatment CGM values (1 patient from the Lantus group and 1 from the NPH group did not have on-treatment CGM).||mmol/L||Standard Deviation|Mean
803587|NCT00993473|Post-Hoc|"Event Rate of All Confirmed Low FSBG (Individual Component of the Primary Endpoint) Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years (Events Per Patient-year)"|"All confirmed low FSBG consisted of all low FSBG readings (values <70 mg/dL) performed at other times."|6 months|Same as for primary endpoint: mITT population.||events per patient-year||Standard Deviation|Mean
803588|NCT00993473|Post-Hoc|"Event Rate of All Confirmed Low CGMS Excursions (Individual Component of Primary Endpoint) Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years (Events Per Patient-year)"|"All confirmed low CGMS excursions consisted of all low continuous glucose monitoring system (CGMS) excursions (interstitial glucose <70 mg/dL [3.9 mmol/L]) confirmed by fingerstick blood glucose (FSBG) <70 mg/dL."|6 months|Same as for primary endpoint: mITT population.||events per patient-year||Standard Deviation|Mean
803589|NCT00993473|Other Pre-specified|Blood Glucose Variability Based on All On-treatment CGMS Values|Calculated for any given patient as the standard deviation (SD) of all CGMS interstitial glucose values recorded over all CGMS placements.|6 months|The population analyzed consisted of patients from the mITT population (as defined for primary outcome measure) with on-treatment CGM values (1 patient from the Lantus group and 1 from the NPH group did not have on-treatment CGM).||mmol/L||Standard Deviation|Mean
803590|NCT00993473|Other Pre-specified|Percent of Blood Glucose (BG) Within the Range of 70 – 180 mg/dL (3.9-10 mmol/L)|Calculated for each patient as the percent of all on-treatment CGMS values falling within the range of 70 – 180 mg/dL (3.9 – 10 mmol/L) inclusive.|6 months|The population analyzed consisted of patients from the mITT population (as defined for primary outcome measure) with on-treatment CGM values (1 patient from the Lantus group and 1 from the NPH group did not have on-treatment CGM).||percent of CGMS values within the range||Standard Deviation|Mean
803591|NCT00993473|Other Pre-specified|Number of Patients With Different Types of Hypoglycemia Events|Definitions of the different types of hypoglycemia events provided in the outcome measure description of the corresponding event rates.|6 months|Same as for primary endpoint: mITT population.||participants|||Number
803592|NCT00993473|Secondary|Average Daily Blood Glucose (BG) Based on CGMS Values: End of Treatment and Change From Baseline to End of Treatment||baseline, 6 months|Same as for primary endpoint: mITT population. However 1 patient in the NPH group did not have baseline CGM value and 2 other patients (1 in the Lantus group and 1 in the NPH group) did not have on-treatment CGM values.||mmol/L||Standard Deviation|Mean
803593|NCT00993473|Secondary|Percentage of Patients Reaching HbA1c Target of Less Than 7.5% at the End of Treatment Visit|Percentage of patients reaching International Society for Pediatric and Adolescent Diabetes (ISPAD)-recommended goals of Glycosylated Hemoglobin A1c <7.5% at the end of treatment visit.|6 months|The population analyzed consisted of patients from the mITT population (as defined for primary outcome measure) with post-baseline HbA1c values. 2 patients from the Lantus group and 7 from the NPH group had no post-baseline HbA1c value.||percentage of participants|||Number
803598|NCT00993473|Secondary|"Event Rate of Nocturnal Hypoglycemia Defined as the Total Number of All Hypoglycemia Episodes Divided by the Total Duration of the On-treatment Period in Years"|Nocturnal hypoglycemia: any event from the “all hypoglycemia” total that occurred between 23:00 and 07:00 hours.|6 months|Same as for primary endpoint: mITT population.||number of events per patient-year||Standard Deviation|Mean
803599|NCT00993473|Secondary|Event Rate of Severe Symptomatic Hypoglycemia Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years|Severe symptomatic hypoglycemia: any event with clinical symptoms considered to result from a hypoglycemic episode for which the patients required the assistance of a third party (ie, other than the patient, or a parent/usual caregiver; eg, from emergency personnel), because the patients/parents could not treat the event with acute neurological impairment directly resulting from the hypoglycemic event. The occurrence of seizure, coma, unconsciousness, or the use of glucagon, were also to qualify a hypoglycemic episode as severe.|6 months|Same as for primary endpoint: mITT population.||number of events per patient-year|Participants|Standard Deviation|Mean
803600|NCT00993473|Secondary|Event Rate of Symptomatic Hypoglycemia (Individual Component of Primary Endpoint) Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years (Events Per Patient-year)|Symptomatic hypoglycemia: any event with clinical symptoms considered to result from hypoglycemia, validated by the study investigator based on data from patient diaries.|6 months|Same as for primary endpoint: mITT population.||events per patient-year||Standard Deviation|Mean
803601|NCT00993473|Primary|"Event Rate of All Hypoglycemia Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years (Events Per Patient-year)"|"The rate of all hypoglycemia was calculated from all hypoglycemia episodes which occurred during the 24-week on-treatment period and consisted of: - symptomatic hypoglycemia episodes validated by the study investigator based on entries in patients' diaries, - low continuous glucose monitoring system (CGMS) excursions (interstitial glucose <70 mg/dL [3.9 mmol/L]) confirmed by fingerstick blood glucose (FSBG) <70 mg/dL, - low FSBG readings (values <70 mg/dL) performed at other times."|6 months|The efficacy population consisted of all randomized patients who received at least one dose of the study medication (modified intent-to-treat [mITT] population). For efficacy analyses, patients were analyzed in the treatment group allocated by the Interactive Voice Response System (IVRS) at randomization (as randomized).||number of events per patient-year||Standard Deviation|Mean
803602|NCT00993499|Secondary|Frequency of Patients With Possible Clinically-significant Abnormalities in Liver Enzymes or Total Bilirubin|Evaluation of laboratory parameters included assessment of the frequency of patients with ALT and AST elevations concurrent with elevated bilirubin and indicative of Hy’s law cases.|From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days|Treated set||Percentage of participants|||Number
803603|NCT00993499|Secondary|Percentage of Patients With Drug-related AEs|Percentage of patients with drug-related adverse events (AEs).|From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days|Treated set||Percentage of participants|||Number
803604|NCT00993499|Secondary|Occurrence of Adverse Events According to CTCAE, Version 3.0|Percentage of participants with adverse events according to highest Common Terminology Criteria for Adverse Events (CTCAE) grade, version 3.0|From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days|Treated set||Percentage of participants|||Number
803605|NCT00993499|Secondary|AUC of Sirolimus at Steady State Over the Dosing Interval τ (AUCτ,ss)|Area under the curve (AUC) of sirolimus at steady state over the dosing interval τ (AUCτ,ss) for afatinib.|24 hours (h) 5 minutes (min), 24h, 23h, 22h, 20h, 18h, 16h, 5min before first afatinib administration and 144h, 311h 55min, 312h, 313h, 314h, 315h, 316h, 317h, 318h, 320h, 336h, 480h after first administration of afatinib|PK set||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
803606|NCT00993499|Secondary|Maximum Measured Plasma Concentration of Sirolimus at Steady State (Cmax,ss)|Maximum measured plasma concentration of sirolimus at steady state (Cmax,ss)|24 hours (h) 5 minutes (min), 24h, 23h, 22h, 20h, 18h, 16h, 5min before first afatinib administration and 144h, 311h 55min, 312h, 313h, 314h, 315h, 316h, 317h, 318h, 320h, 336h, 480h after first administration of afatinib|PK set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
803607|NCT00993499|Secondary|AUC of Afatinib at Steady State Over the Dosing Interval τ (AUCτ,ss)|Area under the curve (AUC) of Afatinib at steady state over the dosing interval τ (AUCτ,ss) for afatinib.|24 hours (h), 311h 55minutes (min), 312h, 313h, 314h, 315h, 316h, 317h, 318h, 320h and 336h after first administration of afatinib|Pharmacokinetic (PK) set which included all patients in the treated set who had taken at least 1 dose of study medication and for whom at least 1 valid blood or plasma concentration was available. No patients in the Afa40+Sir05 group had analyzable data.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
803608|NCT00993499|Secondary|Maximum Measured Plasma Concentration of Afatinib at Steady State (Cmax,ss)|Maximum measured plasma concentration of Afatinib at steady state (Cmax,ss)|24 hours (h), 311h 55minutes (min), 312h, 313h, 314h, 315h, 316h, 317h, 318h, 320h and 336h after first administration of afatinib|Pharmacokinetic (PK) set which included all patients in the treated set who had taken at least 1 dose of study medication and for whom at least 1 valid blood or plasma concentration was available. No patients in the Afa40+Sir05 group had analyzable data.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
803609|NCT00993499|Secondary|Exploratory Examination of EGFR Mutations (Exons 19, 20 and 21 and Others) in Serum/Plasma DNA and Tumour DNA.|"Exploratory examination of Epidermal growth factor (receptor)(EGFR) mutations (Exons 19, 20 and 21 and others) in serum/plasma DNA and tumour DNA.
This endpoint was not analysed in the study report as the available data was too limited."|Multiple time points during the trial|Treated set. This endpoint was not analysed in the study report as the available data was too limited.|||||
803610|NCT00993499|Secondary|Rate of Disease Control|Rate of (unconfirmed) disease control defined as CR, PR, or stable disease (SD), according to RECIST v1.1|From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days|Treated set||Percentage of participants|||Number
803611|NCT00993499|Secondary|Objective Response|Rate of (unconfirmed) objective response, defined as complete response (CR) or partial response (PR) according to RECIST v1.1|From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days|Treated set||Percentage of participants|||Number
803617|NCT00993616|Primary|Objective Response by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (Version 1.1)|Per Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (version 1.1): Complete Response (CR) is disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm; Partial Response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters; Increasing Disease is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions); Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest|From study entry, up to 5 years|||participants|||Number
803618|NCT00993655|Secondary|Overall Survival|Time from the day of randomization to death from any cause.|During the study with median follow-up of 33 months|||months||95% Confidence Interval|Median
803619|NCT00993655|Secondary|Progression Free Survival|Time from the day of randomization until the time when first observation of disease progression (earliest of the dates of first CA125 which meets progression definition and first objective relapse or progression defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions, has been documented or when death due to any cause has been observed.|During the study with median follow-up of 33 months|All patients randomized to the study||months||95% Confidence Interval|Median
803620|NCT00993655|Primary|9-month Progression Rate Post-randomization|It is defined as proportion of patients who had progressed at or before 9 months after randomization, i.e., the time from the randomization to the date when the first observation of disease progression (earliest of the date when the first CA 125 meets progression definition and the date of first objective relapse or progression, defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions, recorded) has been documented or when death due to any cause has been observed was less than or equal to 9 months.|9 months|All randomized patients||Porportion of participants|||Number
803621|NCT00993668|Secondary|Percentage of Subjects Without Baseline Protective Titers Achieving a ≥ 4-fold Titer Increase in ≥ 2 of 3 Influenza Antigens at Week 6 by Concomitant MTX Use.||Baseline, End of single blind period (Week 6)|Of the 224 randomized subjects (114 Placebo, 110 CZP), 169 were in the Per Protocol Set Influenza (PPSI) population (83 Placebo, 86 CZP) without baseline protective titers, and are included in the analysis.||percentage of participants||95% Confidence Interval|Number
803622|NCT00993668|Secondary|Percentage of Subjects Without Baseline Protective Titers Achieving a ≥ 2-fold Titer Increase in ≥ 3 of 6 Pneumococcal Antigens at Week 6 by Concomitant Methotrexate (MTX) Use.||Baseline, End of single blind period (Week 6)|Of the 224 randomized subjects (114 Placebo, 110 CZP), 176 were in the Per Protocol Set Pneumococcal (PPSP) population (88 Placebo, 88 CZP) without baseline protective titers, and are included in the analysis.||percentage of participants||95% Confidence Interval|Number
803623|NCT00993668|Secondary|Percentage of All Subjects With Protective Influenza Antibody Titers (≥1:40 in ≥ 2 of 3 Influenza Antigens) at Week 6.||End of single blind period (Week 6)|Of the 224 randomized subjects (114 Placebo, 110 CZP), 216 were in the Full Analysis Set Influenza (FASI) population (109 Placebo, 107 CZP), and are included in the analysis.||percentage of participants||95% Confidence Interval|Number
803624|NCT00993668|Secondary|Percentage of All Subjects With Protective Pneumococcal Antibody Titers (≥1.6 µg/ml in ≥ 3 of 6 of the Pneumococcal Antigens) at Week 6.||End of single blind period (Week 6)|Of the 224 randomized subjects (114 Placebo, 110 CZP), 217 were in the Full Analysis Set Pneumococcal (FASP) population (110 Placebo, 107 CZP), and are included in the analysis.||percentage of participants||95% Confidence Interval|Number
803625|NCT00993668|Secondary|Percentage of Subjects With no Previous Protective Influenza Antibody Titers at Baseline With Protective Influenza Antibody Titers (≥1:40 in ≥ 2 of 3 Influenza Antigens) at Week 6.||Baseline, End of single blind period (week 6)|Of the 224 randomized subjects (114 Placebo, 110 CZP), 169 were in the Per Protocol Set Influenza (PPSI) population (83 Placebo, 86 CZP) without baseline protective titers but with protective influenza antibody titers, and are included in the analysis.||percentage of participants||95% Confidence Interval|Number
803626|NCT00993668|Secondary|Percentage of Subjects With no Previous Protective Pneumococcal Antibody Titers at Baseline With Protective Pneumococcal Antibody Titers (≥1.6 µg/ml in ≥ 3 of 6 of the Pneumococcal Antigens) at Week 6.||Baseline, End of single blind period (Week 6)|Of the 224 randomized subjects (114 Placebo, 110 CZP), 180 were in the Per Protocol Set Pneumococcal (PPSP) population (90 Placebo, 90 CZP) without baseline protective titers. Of these 180 subjects 150 (75 Placebo, 75 CZP) had protective pneumococcal antibody titers and are included in the analysis.||percentage of participants||95% Confidence Interval|Number
803627|NCT00993668|Secondary|Percentage of All Subjects Achieving a ≥ 4-fold Titer Increase in ≥ 2 of 3 Influenza Antigens (2009/2010 Composition) at Week 6.||End of single blind period (Week 6)|Of the 224 randomized subjects (114 Placebo, 110 CZP), 109 were in the Full Analysis Set Influenza (FASI) population (109 Placebo, 107 CZP), and are included in the analysis.||percentage of participants||95% Confidence Interval|Number
803628|NCT00993668|Secondary|Percentage of All Subjects Achieving a ≥ 2-fold Titer Increase in ≥ 3 of 6 Pneumococcal Antigens (6B, 9V, 14, 18C, 19F, and 23F) at Week 6.||End of single blind period (Week 6)|Of the 224 randomized subjects (114 Placebo, 110 CZP), 217 were in the Full Analysis Set Pneumococcal (FASP) population (110 Placebo, 107 CZP), and are included in the analysis.||percentage of participants||95% Confidence Interval|Number
803629|NCT00993668|Primary|Percentage of Subjects Without Baseline Protective Titers Achieving a ≥ 4-fold Titer Increase in ≥ 2 of 3 Influenza Antigens (2009/2010 Composition) at Week 6.||Baseline, End of single blind period (Week 6)|Of the 224 randomized subjects (114 Placebo, 110 CZP), 169 were in the Per Protocol Set Influenza (PPSI) population (83 Placebo, 86 CZP) without baseline protective titers, and are included in the analysis.||percentage of participants||95% Confidence Interval|Number
808124|NCT01020123|Secondary|Systolic Blood Pressure, Change From Baseline|Summary statistic of change from baseline|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 237 in CSR)||mmHg||Standard Deviation|Mean
803630|NCT00993668|Primary|Percentage of Subjects Without Baseline Protective Titers Achieving a ≥ 2-fold Titer Increase in ≥ 3 of 6 Pneumococcal Antigens (6B, 9V, 14, 18C, 19F, and 23F) at Week 6.||Baseline, End of single blind period (Week 6)|Of the 224 randomized subjects (114 Placebo, 110 CZP), 176 were in the Per Protocol Set Pneumococcal (PPSP) population (88 Placebo, 88 CZP) without baseline protective titers, and are included in the analysis.||percentage of participants||95% Confidence Interval|Number
803631|NCT00993824|Primary|Hypoglycemia Percentage of Time <70 mg/dL Average by Group|Ambulatory glucose profile (AGP) reports were examined for the changes in the incidence of hypoglycemia (CGM<70 mg/dL)|2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2.|||percentage of time <70 mg/dL||Standard Deviation|Mean
803632|NCT00993824|Primary|Wake Norm AUC Average by Group (Normalized)|Wake glucose captured by continuous glucose monitoring (CGM).|2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2.|||mg/(dL/hr) (normalized)||Standard Deviation|Mean
803633|NCT00993824|Primary|Sleep Norm AUC Average by Group (Normalized)|Overnight glucose captured by CGM.|2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2.|||mg/(dL/hr) normalized||Standard Deviation|Mean
803634|NCT00993824|Primary|Total Norm AUC Average by Group (Normalized)|Double Blinded CGM used for 2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2.|2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2.|||mg/(dL/hr) normalized||Standard Deviation|Mean
803635|NCT00993915|Other Pre-specified|Percent Change From Baseline in Lipid Parameters at 1 Month|Percent change from baseline calculated as: 100*(change at Month X)/(baseline value).|Month 1|Not analyzed; LDL data not collected at 1 Month visit, time point erroneously identified in registration for this outcome measure.|||||
803636|NCT00993915|Other Pre-specified|Change From Baseline in Lipid Parameters at 1 Month|Lipid parameters include HDL cholesterol, LDL cholesterol, total cholesterol, and total triglycerides. Change = Month 6 value minus baseline|Month 1|Not analyzed; LDL data not collected at 1 Month visit, time point erroneously identified in registration for this outcome measure.|||||
803637|NCT00993915|Secondary|Percent Change From Baseline in Lipid Parameters|Percent change from baseline calculated as: 100*(change at Month X)/(baseline value).|Month 6|FAS population. Number of participants analyzed (N) = participants with evaluable data; n = number of participants with evaluable data for the specific category. Percent change at Month 3 not analyzed; Month 3 visit not part of final protocol, time point erroneously identified for this outcome measure.||percent change||95% Confidence Interval|Mean
803638|NCT00993915|Secondary|Change From Baseline in Lipid Parameters|Lipid parameters include HDL cholesterol, LDL cholesterol, total cholesterol, and total triglycerides. Change = Month 6 value minus baseline|Month 6|FAS Population. Number of participants analyzed (N) = participants with evaluable data; n = number of participants with evaluable data for the specific category. Change at Month 3 not analyzed; Month 3 visit not part of final protocol, time point erroneously identified for this outcome measure.||mg/dL||95% Confidence Interval|Mean
803639|NCT00993915|Secondary|Percentage of Participants Achieving LDL Level ≤ 100 mg/dL at the 1 Month Visit||Month 1|Not analyzed; LDL data not collected at 1 Month visit, time point erroneously identified for this outcome measure.|||||
803640|NCT00993915|Primary|Percentage of Participants Achieving LDL Level Less Than or Equal to (≤) 100 mg/dL at the 6 Month Visit||Month 6|Full analysis set (FAS) population: all participants who received at least one dose of Atorvastatin (Liprimar) during the observation period and who had at least 1 post-baseline efficacy evaluation. Number of participants analyzed (N)= participants with evaluable data.||percentage of participants||95% Confidence Interval|Number
803641|NCT00993928|Secondary|Distress at Week 6|The Distress Thermometer is a single-item tool which asks patients to describe how much distress he/she has been experiencing in the past week on a scale of 0 to 10 (0=no distress, 10=extreme distress). The Distress Thermometer was selected for this study due to its brevity. Week 7 distress measures were analyzed as percent change from baseline and analyzed between arms with a t-test.|From baseline to week 7|All patients that completed a Distress Thermometer assessment at baseline and week 7 were included in the analysis.||percentage of change||Full Range|Median
803642|NCT00993928|Secondary|Total Mood Disturbance as Measured by Profiles of Mood States B (POMS-B)|The POMS-B is a shortened version of the original POMS with 30 items each asking the patient to select how he/she has been feeling during the past week with respect to an adjective such as “tense”, “angry”, “worn out”, etc., on a 0-4 scale (0=not at all; 4=extremely). The POMS-B consists of six identifiable mood states (tension/anxiety, depression/dejection, anger/hostility, vigor/activity, fatigue/inertia, and confusion/bewilderment) and measures the patient’s total mood disturbance. This study analyzed total mood disturbance (total scale score) as a secondary endpoints. Possible weekly scores ranged from 0-120. Week 7 scores were analyzed as a percentage change from baseline with a negative score representing a worsening condition. A Wilcoxon rank-sum test was used to compare treatment arms.|At baseline and week 7|Patients that completed the POMS-B questionnaire at baseline and week 7 were used in this analysis.||percentage of change||Full Range|Median
803643|NCT00993928|Secondary|Comparing the Efficacy of Two Home-based Sleep Interventions as Therapy for Sleep-wake Disturbances as Measured by the Percent of People Who Show Improved Sleep Per the Pittsburgh Sleep Quality Index (PSQI)|The PSQI has 19 items and seven component scales: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep-wake disturbances, use of sleep medication, and daytime dysfunction. The scoring algorithm yields seven component scales on 0-3 scales which are summed to produce a global score on a 0-21 scale with higher values representing more severe sleep difficulty. The percentage of patients that showed improvement or worsening in sleep score from baseline to Week 7 were analyzed and compared using a Chi-squared test.|Baseline and 7 weeks|Thirty-six patients from Arm A and 31 patients from Arm B had PSQI measurements available for analysis.||percentage of participants|||Number
803698|NCT00985673|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs).|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within the 84-day (Days 0-83) post-vaccination period.|The Total Vaccinated Cohort included all vaccinated subjects.||Subjects|||Number
803644|NCT00993928|Secondary|Efficacy of Home-based Interventions on the Number of Awakenings After Sleep, Sleep Quality, Sleep Difficulty, and Sleep Latency at Baseline and Weeks 4 and 7.|"Overall efficacy was analyzed as a composite of 4 outcomes: 1. sleep difficulty, 2. sleep quality, 3. Number of awakenings, and 4. Sleep latency. These 4 outcomes were measured by the responses to the following questions, respectively: >
How difficult was it to get to sleep last night? (scale 1-5, 5 meaning very easy) >
How deeply did you sleep last night? (scale 1-5, 5 meaning very deeply) >
How many times did you awaken last night? >
How long did it take you to get to sleep last night? > > The 4 questions were analyzed as percent change from baseline after week 4 and after week 7. The percent change between arms was analyzed using a Wilcoxon test."|Baseline and 7 weeks|In Arm A, 38 patients responded to questions during week 4 and 37 responded during week 7. In Arm B, 31 patients responded during week 4 and 30 responded during week 7.||percentage of change||Full Range|Median
803645|NCT00993928|Primary|Change of the (3 Day) Sleep Latency Time and Time to Fall Back Asleep After Awakening During the Night From Baseline to the End of Study at Week 7|"The primary analysis will compare the change in time (in minutes) to fall asleep from baseline to week 7 as reported by question 3 in the sleep diary: How long did it take you to get to sleep last night? and time to fall back asleep after awakening during the night as reported by question 6A on sleep dairy: When waking up after first falling asleep, how long did it take you to fall back to sleep? >
> Data were analyzed as a percent change from baseline to week 7. The percent change were compared between arms using a Wilcoxon rank-sum test."|Baseline and 7 weeks|In Arm A, 4 went off treatment prior to week 7 and 2 had missing data. 23 patients were able to respond to question 6A. In Arm B, 7 did not finish 7 weeks of treatment and 1 patient had missing data. 16 patients responded to question 6A. Therefore, Q3 and Q6A are based on 37 and 23 patients in Arm A and 30 and 23 patients from Arm B, respectively.||percentage change||Full Range|Median
803646|NCT00993954|Secondary|Proportion of Patients With RHS Not Identified by Nurse Pathway.||End of enrollment|||participants|||Number
803647|NCT00993954|Secondary|Proportion of Patients With Presentation Compatible With RHS, Have Reduction Attempted, Who Are Subsequently Diagnosed With Fracture.||Every 3 months during enrollment|||participants|||Number
803648|NCT00993954|Secondary|Time to Discharge From ED (Minutes)||End of enrollment|2 missing data point in the physician group||minutes||Full Range|Median
803649|NCT00993954|Primary|Proportion of Patients With Successful Reduction of Radial Head Subluxation by Nurse, Compared With Physician Controls||10-15 minutes post reduction attempt|||percentage of patients reduced|||Number
803650|NCT00994110|Primary|To Compare 60-day ≥Grade 3 Pancreatic Complication Rates (Fistula, Leak, and Abscess) as Defined by the MSKCC Surgical Secondary Events System Between Patients Who Receive Perioperative SOM230 and Saline Placebo.||60 days|||percentage of participants|||Number
803651|NCT00994123|Post-Hoc|To Explore the Utility of an EGFR Family Receptor-ligand (Heregulin, HRG) as a Predictor of Response to MM-121 and /or Erlotinib in Formalin Fixed (FFPE) Tumor Samples|Tumor tissue samples were obtained from patients prior to enrollment. Samples were analyzed using RNA-ISH for the expression of the biomarker, heregulin. Progression-free survival was assessed using RECIST v 1.1 to determine whether patients whose tumors express HRG have a lower PFS than those whose tumors do not express HRG, and to assess whether the addition of MM-121 to erlotinib can increase PFS in HRG-high patients.|Time from first dose to date of progression, with a median of 8.1 weeks|Patients with available tissue for heregulin testing||months PFS||95% Confidence Interval|Median
803652|NCT00994123|Primary|Phase 2: Progression-free Survival of the MM-121 + Erlotinib Combination|"This was a time-to-event measure using Progression-Free Survival (PFS) comparing MM-121 + erlotinib vs.erlotinib alone. Progression of disease is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Progression free survival was defined as the number of weeks from the date of randomization to the date of death or progression. If neither death nor progression was observed during the study, PFS data was censored at the last non-progressive disease valid tumor assessment unless the patient was discontinued due to symptomatic deterioration. If this occurred, the patient was counted as having progressive disease (PD)."|Time from first dose to date of progression, with a median of 8.1 weeks|||weeks||95% Confidence Interval|Median
803653|NCT00994123|Primary|Phase 1: Determine the Maximum Tolerated Dose Dependent on Reports of Dose-limiting Toxicities|"Using a 3+3 dose escalation model, the maximum tolerated dose was determined by assessing dose-limiting toxicities in each cohort. If 3 patients were treated and passed the observation window, escalation to the next cohort was initiated. If a DLT was reported, 3-4 additional patients were enrolled and observed. If a DLT was observed in the expanded cohort, this dose was considered to be the maximum tolerated dose. The maximum tolerated dose was defined at the cohort in which two dose-limiting toxicities were observed, or as the highest target dose tested in the absence of DLTs.
The determined MTD was used as the recommended Phase 2 dose."|From date of first dose to 30 days after termination, the longest 175 weeks|All participants treated in the Phase 1 dose-escalation portion of the study||dose level of MTD|||Number
803654|NCT00994123|Primary|Phase 1: To Determine the Recommended Phase 2 Dose of the MM-121 + Erlotinib Combination Based Upon Either the Maximum Tolerated Dose (MTD) or the Maximum Feasible Dose of the Combination in Patients With NSCLC.|To establish the safety of escalating doses of MM-121 in combination with erlotinib in order to determine the recommended phase 2 dose of the combination for the second part of the study. Dose-escalation conducted using standard 3+3 model to determine maximum tolerated dose. Reports of Dose-Limiting Toxicities (DLTs) were assessed to determine the MTD.|From date of first dose to 30 days after termination, the longest 175 weeks|||participants reporting DLTs|||Number
803655|NCT00994175|Primary|Baseline - Juniper Asthma Quality of Life Questionnaire (AQLQ) Score|Juniper Asthma Quality of Life Questionnaire (AQLQ) score at the end of the pioglitazone treatment period as compared to the placebo treatment period. The AQLQ is scored on a 7-point scale with 7 = not impaired at all, 1 = severly impaired|Baseline|All subjects who completed both treatment phases of the study||units on a scale||Standard Deviation|Mean
803656|NCT00994175|Primary|16 Weeks - Juniper Asthma Quality of Life Questionnaire (AQLQ) Score|Juniper Asthma Quality of Life Questionnaire (AQLQ) score at the end of the pioglitazone treatment period as compared to the placebo treatment period. The AQLQ is scored on a 7-point scale with 7 = not impaired at all, 1 = severly impaired|16 weeks|All subjects who completed both treatment phases of the study||units on a scale||Standard Deviation|Mean
803657|NCT00994214|Secondary|Number of Subjects Reported Adverse Events During the Study|"For summaries of intensity and causality, individual patients may be reported in more than one category. In the event of multiple episodes of AEs being reported by the same patient during the study, the maximum intensity (severe > moderate > mild) and the most serious causality (related > not related) have been chosen.
TEAE (Treatment emergent adverse event) are reported by Maximum Dose Received in Each Part of the Study."|Up to Visit 10 (An average of 6.5 Months)|"Safety Population
Part B: Arm A: BIM 23A760 1 mg- 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received."||Participants|||Number
803658|NCT00994214|Secondary|Percentage Change in Ring Finger Circumference|Percentage change from Baseline at month X = (Ring finger circumference at month X – ring finger circumference at baseline) x 100 / ring finger circumference at baseline.|Baseline (Day 1) and Month 6|ITT population. N=Number of subjects attended Month 6 (visit 9).||Percentage of Change in Ring Finger circ||Standard Deviation|Mean
803659|NCT00994214|Secondary|Changes in IGF-1||Baseline (Day 1) and Month 6|ITT population||Percentage of ULN||Standard Deviation|Mean
803660|NCT00994214|Secondary|Percent Change From Baseline in the Mean GH From 0-3 Hours at Months 1, 3 and 6|Percentage change from Baseline at month X = (Mean GH at month X - Mean GH at baseline) x 100 / Mean GH at baseline|0-3 hr on Baseline (Day 1) and Months 1, 3 and 6|N=Number of patients randomised to treatment in IGF-1 <2.5 x upper limit of normal (ULN) stratum and IGF-1 ≥2.5 x ULN stratum.||Percentage of change in mean GH||Standard Deviation|Mean
803661|NCT00994214|Secondary|Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1||At Month 1|ITT population. N=Number of subjects attended Month 1 (visit 5).||Percentage of subjects|||Number
803662|NCT00994214|Secondary|Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1||At Month 3|ITT population. N=Number of subjects attended Month 3 (visit 7).||Percentage of subjects|||Number
803663|NCT00994214|Primary|Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1||At Month 6|Intention-to-Treat (ITT) population: All randomized subjects who received at least one dose of study medication. N=Number of subjects attended Month 6 (visit 9).||Percentage of subjects|||Number
803664|NCT00985543|Secondary|Adverse Events|Number of reported adverse events, severity of adverse events and relationship to study drug was assessed by questions, physical examination and laboratory parameters. Adverse event data was used to assess the safety and tolerability of low lopinavir/ritonavir doses.|Up to 11 weeks from screening to final study visit|22 participants completed the three sequential dosing phases and pharmacokinetic evaluations as per protocol. The same 22 participants are in the analysis population for each lopinavir/ritonavir dose (arm).||number of adverse events|||Number
803665|NCT00985543|Primary|Plasma Lopinavir/Ritonavir Concentrations as Measured by the Area Under the Curve (AUC 0-12h).|Pharmacokinetics of plasma lopinavir/ritonavir over a 12-hour dosing interval following administration of lopinavir/ritonavir 400/100mg, 200/150mg and 200/50mg twice daily.|at the end of each 7-day dosing phase|22 participants completed the three sequential dosing phases and pharmacokinetic evaluations as per protocol. The same 22 participants are in the analysis population for each lopinavir/ritonavir dose (arm).||ng.h/mL||90% Confidence Interval|Geometric Mean
803666|NCT00985673|Secondary|Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains.|"Titers were expressed as geometric mean titers (GMTs).
Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008."|At Day 182 after dose 1 vaccination|The According-To-Protocol (ATP) cohort for immunogenicity at Day 182 included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) for whom 1 dose of Flulaval vaccine and 2 doses of pandemic vaccine were administered and results were available for antibodies against H1N1 antigen at Day 182.||Titers||95% Confidence Interval|Geometric Mean
803667|NCT00985673|Secondary|Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains.|"Titers were expressed as geometric mean titers (GMTs).
Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008."|On Days 0, 21 and 63 for the first 4 groups and on Days 0, 42 and 63 for the Unadjuvanted Arepanrix/placebo/Flulaval and Arepanrix/placebo/Flulaval Groups|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.||Titers||95% Confidence Interval|Geometric Mean
803668|NCT00985673|Secondary|Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains.|"Seroconversion factor of the within-subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer.
Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008."|At Day 182 from Day 0|The According-To-Protocol (ATP) cohort for immunogenicity at Day 182 included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) for whom 1 dose of Flulaval vaccine and 2 doses of pandemic vaccine were administered and results were available for antibodies against H1N1 antigen at Day 182.||Fold||95% Confidence Interval|Mean
803669|NCT00985673|Secondary|Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains.|"Seroconversion factor of the within-subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer.
Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008."|On Days 21 and 63 from Day 0 for the first 4 groups and on Days 42 and 63 from Day 0 for the Unadjuvanted Arepanrix/placebo/Flulaval and Arepanrix/placebo/Flulaval Groups|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.||Fold||95% Confidence Interval|Mean
803670|NCT00985673|Secondary|Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains.|"Seroprotection rate was defined as the proportion of subjects with H1N1 reciprocal HI titers ≥ 40 against the tested vaccine virus.
Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008."|At Day 182 after the first dose|The According-To-Protocol (ATP) cohort for immunogenicity at Day 182 included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) for whom 1 dose of Flulaval vaccine and 2 doses of pandemic vaccine were administered and results were available for antibodies against H1N1 antigen at Day 182.||Subjects|||Number
803671|NCT00985673|Secondary|Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains.|"Seroprotection rate was defined as the proportion of subjects with H1N1 reciprocal HI titers ≥ 40 against the tested vaccine virus.
Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008."|before vaccination and on days 21 and 63 for the first 4 groups and before vaccination and on days 42 and 63 for the Unadjuvanted Arepanrix/placebo/Flulaval and Arepanrix/placebo/Flulaval Groups|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.||Subjects|||Number
803672|NCT00985673|Secondary|Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains|"Seroconversion defined as:
For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer
Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008."|At Day 182 from Day 0|The According-To-Protocol (ATP) cohort for immunogenicity at Day 182 included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) for whom 1 dose of Flulaval vaccine and 2 doses of pandemic vaccine were administered and results were available for antibodies against H1N1 antigen at Day 182.||Subjects|||Number
803673|NCT00985673|Secondary|Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains|"Seroconversion defined as:
For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer
Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008."|on Days 21 and 63 from Day 0 for the first 4 groups; on Days 42 and 63 from Day 0 for the Unadjuvanted Arepanrix/placebo/Flulaval and Arepanrix/placebo/Flulaval Groups|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.||Subjects|||Number
803674|NCT00985673|Secondary|Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains.|"Seroconversion factor was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal Hemagglutination Inhibition (HI) titer to the prevaccination reciprocal HI titer.
Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008.
For the analysis the Flulaval/placebo/unadjuvanted Arepanrix Group and the Flulaval/placebo/Arepanrix Group were pooled."|At Day 21 from Day 0 for the pooled group, Flulaval/unadjuvanted Arepanrix/placebo and Flulaval/Arepanrix/placebo Groups; at Day 63 from Day 42 for Unadjuvanted Arepanrix/placebo/Flulaval Group and Arepanrix/placebo/Flulaval Group|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.||Fold||95% Confidence Interval|Mean
803675|NCT00985673|Secondary|Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains|"Seroprotection was defined as the proportion of subjects with H1N1 reciprocal Hemagglutination Inhibition (HI) titers ≥ 1:40 against the tested vaccine virus.
Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008.
For the analysis the Flulaval/placebo/unadjuvanted Arepanrix Group and the Flulaval/placebo/Arepanrix Group were pooled."|At Day 21 for the pooled group, Flulaval/unadjuvanted Arepanrix/placebo and Flulaval/Arepanrix/placebo Groups; at Day 63 for Unadjuvanted Arepanrix/placebo/Flulaval Group and Arepanrix/placebo/Flulaval Group|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.||Subjects|||Number
803676|NCT00985673|Secondary|Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains.|"Seroconversion defined as:
For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer
Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008.
For the analysis the Flulaval/placebo/unadjuvanted Arepanrix Group and the Flulaval/placebo/Arepanrix Group were pooled."|At Day 21 from Day 0 for the pooled group, Flulaval/unadjuvanted Arepanrix/placebo and Flulaval/Arepanrix/placebo Groups; at Day 63 from Day 42 for Unadjuvanted Arepanrix/placebo/Flulaval Group and Arepanrix/placebo/Flulaval Group|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.||Subjects|||Number
803677|NCT00985673|Secondary|Seroconversion Factor for Antibodies Against A/California Strain.|Seroconversion factor was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the prevaccination reciprocal HI titer.|At Day 63 from Day 21 for Flulaval/placebo/unadjuvanted Arepanrix and Flulaval/placebo/Arepanrix Groups; At Day 42 from Day 0 for the 4 other groups|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.||Fold||95% Confidence Interval|Mean
803678|NCT00985673|Secondary|Number of Seroprotected Subjects for Antibodies Against A/California Strain.|Seroprotection rate was defined as the proportion of subjects with H1N1 reciprocal HI titers ≥ 40 against the tested vaccine virus.|At Day 63 for Flulaval/placebo/unadjuvanted Arepanrix and Flulaval/placebo/Arepanrix Groups; At Day 42 for the 4 other groups.|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.||Subjects|||Number
803699|NCT00985673|Secondary|Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed|Laboratory parameters assessed were serum urea nitrogen (SUN), white blood cells (WBC), red blood cells (RBC). For each parameter and for each range it was assessed whether the values of the subjects were unknown, above, below or within the range.|On Days 0, 7, 21, 28, 42, 63 and 182|The Total Vaccinated cohort included all vaccinated subjects||Subjects|||Number
803679|NCT00985673|Secondary|Number of Seroconverted Subjects for Antibodies Against A/ California Strain.|"Seroconversion rate was defined as the incidence rate of vaccinees who had either a pre-vaccination titer recorded as < 1:10 and a post-vaccination reciprocal titer ≥ 40 or a pre-vaccination reciprocal titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer.
Seroconversion defined as:
For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer"|At Day 63 from Day 21 for Flulaval/placebo/unadjuvanted Arepanrix and Flulaval/placebo/Arepanrix Groups; At Day 42 from Day 0 for the 4 other groups|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.||Subjects|||Number
803680|NCT00985673|Secondary|Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flu A/California H1N1 Strain.|Titers were expressed as geometric mean antibody titers (GMTs).|At Day 182|The According-To-Protocol (ATP) cohort for immunogenicity at Day 182 included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) for whom 1 dose of Flulaval vaccine and 2 doses of pandemic vaccine were administered and results were available for antibodies against H1N1 antigen at Day 182.||Titers||95% Confidence Interval|Geometric Mean
803681|NCT00985673|Secondary|Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flu A/California H1N1 Strain.|Titers were expressed as geometric mean antibody titers (GMTs).|On Days 0, 21, 42 and 63|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.||Titers||95% Confidence Interval|Geometric Mean
803682|NCT00985673|Secondary|Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains.|"The antibody response against each of the three Flulaval vaccine components in subjects exposed to pre-treatment with two doses of the unadjuvanted formulation of Arepanrix vaccine and in subjects exposed to a single dose of Flulaval vaccine.
Flulaval vaccine strains were Flu A/Brisbane/59/2007 H1N1, Flu A/Uruguay/716/2007 H3N2 and Flu B/Brisbane/60/2008.
Titers were expressed as geometric mean antibody titers (GMTs)."|21 days after the Flulaval vaccination (Day 63 for Unadjuvanted Arepanrix/placebo/Flulaval Group and Day 21 for Flulaval/placebo/unadjuvanted Arepanrix and Flulaval/placebo/Arepanrix Groups)|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.||Titers||95% Confidence Interval|Geometric Mean
803683|NCT00985673|Secondary|Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains.|"The antibody response against each of the three Flulaval vaccine components in subjects exposed to pre-treatment with two doses of Arepanrix vaccine and in subjects exposed to a single dose of Flulaval vaccine.
Flulaval vaccine strains were Flu A/Brisbane/59/2007 H1N1, Flu A/Uruguay/716/2007 H3N2 and Flu B/Brisbane/60/2008.
Titers were expressed as geometric mean antibody titers (GMTs)."|21 days after the Flulaval vaccination (Day 63 for Arepanrix/placebo/Flulaval Group and Day 21 for Flulaval/placebo/unadjuvanted Arepanrix and Flulaval/placebo/Arepanrix Groups)|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.||Titers||95% Confidence Interval|Geometric Mean
803684|NCT00985673|Secondary|Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains.|"The antibody response against each of the three Flulaval vaccine components in subjects exposed to co-administration of Flulaval vaccine with the first of two doses of the unadjuvanted formulation of Arepanrix vaccine and in subjects exposed to a single dose of Flulaval vaccine.
Flulaval vaccine strains were Flu A/Brisbane/59/2007 H1N1, Flu A/Uruguay/716/2007 H3N2 and Flu B/Brisbane/60/2008.
Titers were expressed as geometric mean antibody titers (GMTs)."|21 days after the Flulaval vaccination (at Day 21).|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.||Titers||95% Confidence Interval|Geometric Mean
803685|NCT00985673|Secondary|Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains.|"The antibody response against each of the three Flulaval vaccine components in subjects exposed to co-administration of Flulaval vaccine with the first of two doses of Arepanrix vaccine and in subjects exposed to a single dose of Flulaval vaccine.
Flulaval vaccine strains were Flu A/Brisbane/59/2007 H1N1, Flu A/Uruguay/716/2007 H3N2 and Flu B/Brisbane/60/2008.
Titers were expressed as geometric mean antibody titers (GMTs)."|21 days after the Flulaval vaccination (at Day 21).|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.||Titers||95% Confidence Interval|Geometric Mean
803686|NCT00985673|Secondary|Hemagglutination Inhibition (HI) Antibody Titers Against A/California/7/2009 H1N1 Vaccine Strain.|"The A/California vaccine virus-homologous antibody response was measured in subjects pre-treated with Flulaval who subsequently received two doses of the unadjuvanted formulation of Arepanrix vaccine compared to subjects pre-treated with Flulaval vaccine who subsequently received two doses of Arepanrix vaccine.
Titers were expressed as geometric mean antibody titers (GMTs)."|21 days after the second dose of the pandemic vaccine (at Day 63)|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.||Titers||95% Confidence Interval|Geometric Mean
803700|NCT00985673|Secondary|Number of Subjects Reporting Solicited General Symptoms.|Solicited general symptoms assessed were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and temperature. Temperature is defined as an axillary temperature equal to or above 38.0 degrees Celsius (°C).|During a 7-day follow-up period (Days 0-6) post-vaccination period|The Total Vaccinated cohort included all vaccinated subjects||Subjects|||Number
803687|NCT00985673|Secondary|Hemagglutination Inhibition (HI) Antibody Titers Against A/California/7/2009 H1N1 Vaccine Strain.|"The A/California vaccine virus-homologous antibody response was measured in subjects having received two doses of the unadjuvanted formulation of Arepanrix vaccine, with prior treatment with Flulaval vaccine 21 days before the first dose and in subjects having received two doses of the unadjuvanted formulation of Arepanrix vaccine alone.
Titers were expressed as geometric mean antibody titers (GMTs)."|21 days after the second dose of the unadjuvanted formulation of Arepanrix vaccine (Day 63 for Flulaval/placebo/unadjuvanted Arepanrix Group and Day 42 for Unadjuvanted Arepanrix/placebo/Flulaval Group)|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.||Titers||95% Confidence Interval|Geometric Mean
803688|NCT00985673|Secondary|Hemagglutination Inhibition (HI) Antibody Titers Against A/California/7/2009 H1N1 Vaccine Strain.|"The A/California vaccine virus-homologous antibody response was measured in subjects having received two doses of Arepanrix vaccine, with prior treatment with Flulaval vaccine 21 days before the first dose and in subjects having received two doses of Arepanrix vaccine alone.
Titers were expressed as geometric mean antibody titers (GMTs)."|21 days after the second dose of Arepanrix vaccine (Day 63 for Flulaval/placebo/Arepanrix Group and Day 42 for Arepanrix/placebo/Flulaval Group)|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.||Titers||95% Confidence Interval|Geometric Mean
803689|NCT00985673|Primary|Hemagglutination Inhibition (HI) Antibody Titers Against A/California/7/2009 H1N1 Vaccine Strain.|"The A/California vaccine virus-homologous antibody response was measured in subjects having received Flulaval vaccine co-administered with the first dose of the unadjuvanted formulation of Arepanrix vaccine, and in subjects having received two doses of the unadjuvanted formulation of Arepanrix vaccine alone.
Titers were expressed as geometric mean antibody titers (GMTs)."|21 days after the second dose of the unadjuvanted formulation of Arepanrix vaccine (at Day 42)|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.||Titers||95% Confidence Interval|Geometric Mean
803690|NCT00985673|Primary|Hemagglutination Inhibition (HI) Antibody Titers Against A/California/7/2009 H1N1 Vaccine Strain.|"The A/California vaccine virus-homologous antibody response was measured in subjects having received Flulaval vaccine co-administered with the first dose of Arepanrix vaccine, and in subjects having received two doses of Arepanrix vaccine alone.
Titers were expressed as geometric mean antibody titers (GMTs)."|21 days after the second dose of Arepanrix vaccine (at Day 42).|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.||Titers||95% Confidence Interval|Geometric Mean
803691|NCT00985673|Secondary|Vaccine Response Rates (VRR) for Microneutralization Antibody Titers Against A/California/7/2009 (H1N1) Strain.|"Arepanrix vaccine strain and the unadjuvanted formulation of Arepanrix vaccine strain was A/California/7/2009 (H1N1).
Vaccine Response Rate for microneutralization titers was defined as the incidence rate of vaccinees with at least a 4-fold increase in post vaccination reciprocal titer relative to Day 0.
Microneutralization testing was cancelled."|On Days 0, 21, 42, 63 and 182|Microneutralization testing was cancelled.|||||
803692|NCT00985673|Secondary|Number of Subjects With a Microneutralization Titer Greater Than or Equal to 1:28 for Antibodies Against A/California/7/2009 (H1N1) Strain.|"Arepanrix vaccine strain and the unadjuvanted formulation of Arepanrix vaccine strain was A/California/7/2009 (H1N1).
The antibody cut-off value assessed was a titer of 1:10 and this value was considered as seropositivity.
Seronegative subject is a subject whose antibody titer is below the cut-off value, a seropositive subject is a subject whose antibody titer is greater than or equal to the cut-off value. Microneutralization titers < 1:28 were considered below the cut-off.
Microneutralization testing was cancelled."|On Days 0, 21, 42, 63 and 182|Microneutralization testing was cancelled.|||||
803693|NCT00985673|Secondary|Microneutralization Antibody Titers Against A/California/7/2009 (H1N1) Strain.|"Titers were expressed as geometric mean titers (GMTs) and measured by microneutralization.
Arepanrix vaccine strain and the unadjuvanted formulation of Arepanrix vaccine strain was A/California/7/2009 (H1N1).
Microneutralization testing was cancelled."|On Days 0, 21, 42, 63 and 182|Microneutralization testing was cancelled.|||||
803694|NCT00985673|Secondary|Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed|Laboratory parameters assessed were neutrophils (NEU), lymphocytes (LYM), monocytes (MON) and platelets (PLA). For each parameter and for each range it was assessed whether the values of the subjects were unknown, in above, below or within the range.|On Days 0, 7, 21, 28, 42, 63 and 182|The Total Vaccinated cohort included all vaccinated subjects||Subjects|||Number
803695|NCT00985673|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs).|"The day 329 was the last contact day with the subjects reporting serious adverse events.
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects."|During the entire study period (Days 0-329).|The Total Vaccinated Cohort included all vaccinated subjects.||Subjects|||Number
803696|NCT00985673|Secondary|Number of Subjects Reporting Potential Immune Diseases (pIMDs).|The day 406 was the last contact day with the subjects reporting the event. Potential immune-mediated diseases (pIMDs) are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.|During the entire study period (Days 0-406).|The Total Vaccinated Cohort included all vaccinated subjects.||Subjects|||Number
803697|NCT00985673|Secondary|Number of Subjects Reporting Medically Attended Visits (MAEs).|The day 368 was the last contact day for the last subject reporting the event. For each solicited and unsolicited symptom the subject experienced, the subject was asked if they received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel for any reason.|During the entire study period (Days 0-368).|The Total Vaccinated Cohort included all vaccinated subjects.||Subjects|||Number
803702|NCT00985673|Secondary|Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed|Laboratory parameters assessed were creatinine (CREA), bilirubin (BIL) (direct (D)), eosinophils (EOS), hemoglobin (Hgb), hematocrit (Hct). For each parameter and for each range it was assessed whether the values of the subjects were unknown, in above, below or within the range.|On Days 0, 7, 21, 28, 42, 63 and 182|The Total Vaccinated cohort included all vaccinated subjects||Subjects|||Number
803703|NCT00985673|Secondary|Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed|Laboratory parameters assessed were alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT), alkaline phosphatase (AP), bilirubin (BIL) (total (T)), basophils (BAS). For each parameter and for each range it was assessed whether the values of the subjects were in unkown, above, below or within the range.|On Days 0, 7, 21, 28, 42, 63 and 182|The Total Vaccinated Cohort included all vaccinated subjects.||Subjects|||Number
803704|NCT00985673|Secondary|Number of Influenza-specific Cluster of Differentiation 8 (CD8) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α).|"Influenza-specific CD8 T-Cells were stimulated in vitro with A/California virus and seasonal Influenza viruses, related antigens or derived peptides.
Stimulating antigens were A/Brisbane, A/California, pool peptides H1N1 and pool FLU."|On Days 0, 7, 21, 28, 42, 63 and 182|The According-To-Protocol (ATP) cohort for immunogenicity at Day 182 included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) for whom 1 dose of Flulaval vaccine and 2 doses of pandemic vaccine were administered and results were available for antibodies against H1N1 antigen at day 182.||Number of T cells/million||Standard Deviation|Mean
803705|NCT00985673|Secondary|Number of Influenza-specific Cluster of Differentiation 4 (CD4) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α).|"Influenza-specific CD4 T-Cells were stimulated in vitro with A/California virus and seasonal Influenza viruses, related antigens or derived peptides.
Stimulating antigens were A/Brisbane, A/California, pool peptides H1N1 and pool FLU."|On Days 0, 7, 21, 28, 42, 63 and 182|The According-To-Protocol (ATP) cohort for immunogenicity at Day 182 included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) for whom 1 dose of Flulaval vaccine and 2 doses of pandemic vaccine were administered and results were available for antibodies against H1N1 antigen at day 182.||Number of T cells/million||Standard Deviation|Mean
803706|NCT00985686|Secondary|Spiritual Involvement and Belief Scale (SIBS)|Measure of spiritual well-being in 19 to 24 year olds. The instrument is self-administered and contains 26 items in a Likert-type format.|At 8 week intervals over a 24 week period||||||
803707|NCT00985686|Secondary|Spiritual Well-Being Scale (SWBS)|Measure of level spiritual well-being in 13-18 year olds. The self administered 10-item version was used.|At 8 week intervals over a 24 week period||||||
803708|NCT00985686|Secondary|Profile of Mood States (POMS)|Measure of psychological well-being in 19 to 24 year olds. The POMS has the format of an adjective check list and consists of 65 items. It provides a total score of mood disturbance and six factor based subscale scores.|At 8 week intervals over a 24 week period||||||
803709|NCT00985686|Secondary|Six Factor Self-Concept Scale|Measure of self concept in 19 to 24 year olds. The Six-Factor Self-Concept Scale is a multidimensional measure of adult self-concept that was designed to have broad applicability across life settings, roles, and activities. The scale consist of 115 items and assess six factors including likability, morality, task accomplishment, giftedness, power and vulnerability.|At 8 week intervals over a 24 week period||||||
803710|NCT00985686|Secondary|Piers-Harris Children’s Self-Concept Scale - Second Edition (Piers Harris 2)|Measure of self-concept in 13 to 18 year olds. The scale can be completed in 10-15 minutes and includes 60 items covering six subscales: physical appearance and attributes, intellectual and school status, happiness and satisfaction, freedom from anxiety, behavioural adjustment and popularity.|At 8 week intervals over a 24 week period||||||
803711|NCT00985686|Primary|Hamilton Depression Rating Scale (HAMD)|Measure of depression severity in individuals 19 to 24 years of age. HAMD total scores includes the sum of 17-items, with eight items scored on a range of 0 (absent) to 2 (marked or definite) and nine scored on a range of 0 (absent) to 4 (very severe). The level of depression was based on the following scoring ranges: 7 or under not depressed, 8-13 some depressive symptoms but no depressive disorder, 12-15 mild depression, 16-19 moderate depression, 20-24 moderately severe depression, and 25+ severe depression. To meet eligibility requirements, participants required a total score of 12-24.|At 8 week intervals over a 24 week period|||units on a scale||Standard Error|Mean
803712|NCT00985686|Primary|Children's Depression Rating Scale Revised (CDRS-R)|Measure of depression severity in individuals 13 to 18 years of age. CDRS-R total raw scores includes the sum of 17 items, each item's scoring range is from 1 (no difficulties) to 5 (severe clinically significant difficulties) or 1 (no difficulties) to 7 (severe clinically significant difficulties), with a total possible raw score ranging from 17 to 113. To meet eligibility requirements, participants required a total raw score of 40 to 70.|At 8 week intervals over a 24 week period|||units on a scale||Standard Error|Mean
803713|NCT00985712|Secondary|30-Day Adjusted Rates of Self-Reported Hyperglycemic Episodes at Any Time From Baseline Through Week 24|Hyperglycemic episode is defined as blood glucose measurement >18 mmol/L (324 mg/dL). Adjusted rate = number of events in study period, divided by number of days in study period, then multiplied by 30.|Baseline through Week 24|Randomized participants who took at least one dose of study drug with post-baseline hyperglycemia follow-up.||number of events per 30 days||Standard Deviation|Mean
803714|NCT00985712|Secondary|30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes at Any Time From Baseline Through Week 24|Hypoglycemic episode is defined as blood glucose measurement ≤3.9 millimoles/Liter (mmol/L; 70 milligrams/deciliter [mg/dL]). Adjusted rate = number of events in study period, divided by number of days in study period, then multiplied by 30.|Baseline through Week 24|Randomized participants who took at least one dose of study drug with post-baseline hypoglycemia follow-up.||number of events per 30 days||Standard Deviation|Mean
803791|NCT00986102|Primary|Number of Participants With the Usage of Doripenem as Per the Approved Indication|Early onset of Nosocomial Pneumonia (NP) and Ventilator-Associated Pneumonia (VAP) is defined as less than 5 days after hospitalization and late onset of NP and VAP is defined as more than or equal to 5 days after hospitalization|5 to 14 days|Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication.||Participants|||Number
803715|NCT00985712|Secondary|Score in Insulin Delivery System Questionnaire (IDSQ) - Willingness to Continue at Week 24 Endpoint|IDSQ is used to evaluate acceptance of study pen. Willingness to continue was assessed by a single question, rated from 1 to 5 (1=Definitely unwilling and 5=Definitely willing). Higher score indicates stronger desire to continue. Least Squares (LS) Mean values were controlled for treatment and baseline score.|Week 24|Participants in full analysis population set who had Week 24 measurements.||units on a scale||95% Confidence Interval|Least Squares Mean
803716|NCT00985712|Secondary|Percentage of Participants Achieving Hemoglobin A1c (HbA1c) ≤7.5% and ≤7.0% at Week 24 Endpoint||Week 24|Participants in full analysis population set who had Week 24 measurements.||percentage of participants|||Number
803717|NCT00985712|Primary|Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 Endpoint|HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least Squares (LS) Mean values were controlled for treatment, visit, treatment*visit interaction, screening HbA1c (≤9% / >9%), change of prandial insulin at baseline, and baseline HbA1c.|Baseline, Week 24|Participants in full analysis population set with missing values accounted for using mixed model repeated measures (MMRM).||percentage of glycosylated hemoglobin||95% Confidence Interval|Least Squares Mean
803718|NCT00985725|Secondary|Change From Baseline in Sheehan Suicidality Tracking Scale (STS) Total Score at Week 9|The STS is an 8-question clinician-rated assessment of suicidal ideation, suicidal behavior, and accidents. The items are scored on a 5-point Likert scale from 0 (not at all) to 4 (extremely) and summed to produce a total score ranging from 0 to 32. Lower scores indicate reduced suicidal tendencies.|Baseline and week 9|SAS population was used for this assessment. However, not all subjects from the SAS completed this assessment, therefore the total number of subjects analyzed for this outcome is less than the total number of subjects that comprise the SAS population.||Scores on a scale||Standard Deviation|Mean
803719|NCT00985725|Secondary|Change From Baseline in the Generalized Anxiety Disorder 7-Item (GAD-7) Total Score at Week 9, LOCF|The GAD-7 is a 7-item self-report questionnaire for assessing anxiety severity. Each item is scored using a scale that ranges from 0 (not at all) to 3 (nearly every day) with total scores ranging from 0 to 21. Lower scores indicate a reduction in anxiety.|Baseline and week 9|SAS||Scores on a scale||Standard Deviation|Mean
803720|NCT00985725|Secondary|Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at Week 11|ACSA scale has 16 symptom items rated on a scale from 0 (not at all) to 4 (extremely) with a possible total score range of 0 to 64. Higher scores indicate greater withdrawal symptom severity.|Baseline and week 11|SAS population was used for this assessment. However, not all subjects from the SAS completed this assessment, therefore the total number of subjects analyzed for this outcome is less than the total number of subjects that comprise the SAS population.||Scores on a scale||Standard Deviation|Mean
803721|NCT00985725|Secondary|Change From Baseline in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Total Scores at up to 9 Weeks/Endpoint|The Q-LES-Q is a 93-item self-report questionnaire on quality of life and health. Each item is rated on a 5-point scale from 1 (very poor) to 5 (very good) with a total score ranging from 93 to 465. Higher scores indicate greater satisfaction.|Baseline and up to 9 weeks/Endpoint|FAS population was used for this assessment. However, not all subjects from the FAS completed this assessment, therefore the total number of subjects analyzed for this outcome is less than the total number of subjects that comprise the FAS population.||Scores on a scale||Standard Deviation|Mean
803722|NCT00985725|Secondary|Change From Baseline in Short Form-12 Health Survey (SF-12) Scale Total Scores at Week 9|The SF-12 is a 12-item self-report questionnaire that is a subset of the SF-36 Health Survey. The survey captures physical and mental health. Each of the 12 items is scored using various scales with a total score ranging from 0 (lowest level of health) to 100 (highest level of health).|Baseline and week 9|FAS population was used for this assessment. However, not all subjects from the FAS completed this assessment, therefore the total number of subjects analyzed for this outcome is less than the total number of subjects that comprise the FAS population.||Scores on a scale||Standard Deviation|Mean
803723|NCT00985725|Secondary|Change From Baseline in CSFQ-14 Total Scores for Females at Week 9, LOCF|This is a 14 item self-report tool that evaluates sexual functioning. Each item is scored on a 5-point Likert scale ranging from 1 (never) to 5 (always) with total scores ranging from 14 to 70. Higher scores reflect better sexual functioning.|Baseline and week 9|Only the females from the SAS population were used and not all of them completed this outcome assessment.||Scores on a scale||Standard Deviation|Mean
803724|NCT00985725|Secondary|Change From Baseline in Changes in Sexual Functioning Questionnaire (CSFQ-14) Total Scores for Males at Week 9, LOCF|This is a 14 item self-report tool that evaluates sexual functioning. Each item is scored on a 5-point Likert scale ranging from 1 (never) to 5 (always) with total scores ranging from 14 to 70. Higher scores reflect better sexual functioning.|Baseline and week 9|The Safety Analysis Set (SAS) defined as all randomized subjects who took at least 1 dose of investigational product and for whom at least 1 follow-up safety assessment was completed. Only the males from the SAS population were used and not all of them completed this outcome assessment.||Scores on a scale||Standard Deviation|Mean
803725|NCT00985725|Secondary|Change From Baseline in Endicott Work Productivity Scale (EWPS) Total Score at up to 9 Weeks/Endpoint|The EWPS quantifies work performance, productivity attitudes and behaviors assessing 25 items on a scale ranging from 0 (high performance) to 4 (lowest performance). Scores range from 0 to 100 with 100 representing lowest productivity.|Baseline and up to 9 weeks/Endpoint|FAS population was used for this assessment. However, not all subjects from the FAS completed this assessment, therefore the total number of subjects analyzed for this outcome is less than the total number of subjects that comprise the FAS population.||Scores on a scale||Standard Error|Least Squares Mean
803726|NCT00985725|Secondary|Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) at Week 9, LOCF|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|Week 9|FAS||percentage of participants|||Number
803727|NCT00985725|Secondary|Percent of Participants With CGI-S at up to 9 Weeks/Endpoint|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|Up to 9 weeks/Endpoint|FAS population was used for this assessment. However, not all subjects from the FAS completed this assessment, therefore the total number of subjects analyzed for this outcome is less than the total number of subjects that comprise the FAS population.||percentage of participants|||Number
803729|NCT00985725|Secondary|Change From Baseline in Central Nervous System Vital Signs Computerized Cognitive Testing Battery Neurocognitive Domain and Index Scores at up to 9 Weeks/Endpoint|This measures the speed and accuracy of basic mental functions. Scores are normalized from raw scores and present an age matched score relative to other people in a normative sample. Scores are normalized with a mean of 100 and standard deviation of 15. Scores < 70 indicate likely deficit and impairment, and scores > 110 indicate high function and capacity. Higher scores are better.|Baseline and up to 9 weeks/Endpoint|FAS||Response scores||Standard Deviation|Mean
803730|NCT00985725|Secondary|Change From Baseline in BRIEF-A T-scores at Week 9, LOCF|BRIEF-A is a validated 75-item questionnaire. Items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.|Baseline and week 9|FAS||T-scores||Standard Error|Least Squares Mean
803731|NCT00985725|Secondary|Change From Baseline in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Total Score at Week 9 - (LOCF)|MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression.|Baseline and week 9|FAS||Scores on a scale||Standard Error|Least Squares Mean
803732|NCT00985725|Primary|Change From Baseline in Behavior Rating Inventory of Executive Function - Adult Version Global Executive Composite T-score (BRIEF-A GEC T) at Week 9, Last Observation Carried Forward (LOCF)|BRIEF-A Global Executive Composite assesses behavioral aspects of executive function. Items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.|Baseline and week 9|The Full Analysis Set (FAS) defined as all randomized subjects who took at least 1 dose of randomized investigational product and had at least 1 primary efficacy assessment after baseline.||T-scores||Standard Error|Least Squares Mean
803733|NCT00985738|Primary|To Determine the Effect of Short-term Intake of Daily Dutasteride Prostate Cancer Volume, Distribution Within the Gland and Gleason Score Sum in Patients in Comparison to Placebo After Adjusting for Changes in Prostate Gland Volume.|The effect of Dutasteride intake on the following parameters as detected by mapping biopsy vs. initial trans-rectal biopsy in the treatment arm and the control group: change in prostate gland volume, change in distribution within the gland, and change in Gleason score sum.|24 Months|"The study was terminated. Study end points were not reached. No data were collected"|||||
803734|NCT00985751|Secondary|Level of Anti-dPly Antibodies Inhibiting Ply Haemolysis Activity|Inhibition of haemolysis activity of pneumolysin (Ply) by anti-dPly antibodies was measured in vitro by mean of a haemolytic assay. The haemolysis activity could be followed by measuring the level of haemoglobin released. Anti-dPly titers (for inhibition of haemolytic activity) ≥ 140.|One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.||Titers||95% Confidence Interval|Geometric Mean
803735|NCT00985751|Secondary|Antibody Concentrations to Protein D (Anti-PD)|Seropositivity status, defined as anti-PD antibody concentrations ≥ 112 Luminex Units per milliliter (LU/mL).|One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.||LU/mL||95% Confidence Interval|Geometric Mean
803736|NCT00985751|Secondary|Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes|Seropositivity status, defined as Opsonophagocytic activity against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F and cross-reactive serotypes 6A and 19A ≥ 8.|One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.||Titers||95% Confidence Interval|Geometric Mean
803737|NCT00985751|Secondary|Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations|Seropositivity status, defined as anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F and cross-reactive serotype 6A and 19 antibody concentrations ≥ 0.05 microgram per milliliter (µg/mL).|One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.||µg/mL||95% Confidence Interval|Geometric Mean
803738|NCT00985751|Secondary|Anti-pneumococcal dPly and PhtD Proteins Antibody Concentrations|Seropositivity status, defined as anti-pneumococcal dPly antibody concentrations ≥ 599 Luminex Units per milliliter (LU/mL) and anti-pneumococcal PhtD antibody concentrations ≥ 391 LU/mL.|One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.||LU/mL||95% Confidence Interval|Geometric Mean
803739|NCT00985751|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period starting at the administration of the first vaccine dose up to study end (from Day 0 up to Month 7)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.||Participants|||Count of Participants
803740|NCT00985751|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. “Any” is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.|During the 31-day (Days 0-30) follow-up period after the booster dose|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet filled in.||Participants|||Count of Participants
803792|NCT00986154|Secondary|Clinically Relevant Bleeding (i.e., Major or Clinically Relevant Non-major Bleeding) Occurring During Treatment|Clinically relevant bleeding (i.e., major or clinically relevant non-major bleeding) occurring during treatment plus 3 days after their last dose for that time period.|12 months from time of randomization|Safety Analysis Set||participants with an event|||Number
835357|NCT01286805|Secondary|Incidence of Nausea|The number of participants with nausea.|Day of surgery prior to discharge|||participants|||Number
803741|NCT00985751|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. “Any” is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.|During the 31-day (Days 0-30) follow-up period after each primary dose|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.||Participants|||Count of Participants
803742|NCT00985751|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms assessed include drowsiness, fever (defined as rectally temperature ≥ 38.0°C), irritability, and loss of appetite. Grade 3 drowsiness = drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectally temperature) above (>) 40.0 degree Celsius (°C). Grade 3 irritability = crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite = not eating at all. “Any” is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination.|During the 7-day (Days 0-6) post-vaccination period following each dose (Dose 1, Dose 2, Booster dose)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet filled in.||Participants|||Count of Participants
803743|NCT00985751|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (>) 30 millimeters (mm). “Any” is defined as incidence of the specified symptom regardless of intensity.|During the 7-day (Days 0-6) post-vaccination period following each dose (Dose 1, Dose 2 and Booster dose)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet filled in.||Participants|||Count of Participants
803744|NCT00985751|Primary|Number of Subjects With Fever > 40.0°C (Rectal Temperature)|The number of subjects with rectal temperature higher (>) than 40.0 degrees Celsius (°C) is reported.|Within 7 days (Day 0-Day 6) following at least one dose of the primary vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.||Participants|||Count of Participants
803745|NCT00985751|Primary|Number of Subjects With Fever > 40.0°C (Rectal Temperature)|The number of subjects with rectal temperature higher (>) than 40.0 degrees Celsius (°C) is reported.|Within 7 days (Day 0-Day 6) following at least one dose of the primary vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.||Participants|||Count of Participants
803746|NCT00985790|Secondary|Number of Subjects With Any Adverse Events of Specific Interest (AESIs).|An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.|From Day 0 to Day 180 (study conclusion)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||subjects|||Number
803747|NCT00985790|Secondary|Number of Subjects With Any and Related Serious Adverse Events (SAEs).|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Any was defined as occurrence of any symptom regardless of intensity grade and related was an event assessed by the investigator as causally related to the study vaccination.|From Day 0 to Day 180 (study conclusion)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||subjects|||Number
803748|NCT00985790|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|An unsolicited AE covers any untoward medical occurrence in a subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to vaccination.|During the 28-day follow-up period (Days 0 to 27) after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||subjects|||Number
803749|NCT00985790|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature (defined as axillary temperature equal to or above 37.5 degrees Celsius). For other symptoms: Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms assessed by the investigator as related to vaccination. Grade 3 drowsiness = prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 irritability= crying that could not be comforted/prevented normal activity. Grade 3 temperature: ≥ 39.0°C.|During the 7-day follow-up period (Days 0 to 6) after any vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with the symptom sheet completed.||subjects|||Number
803750|NCT00985790|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms.|Assessed solicited local symptoms were pain, redness and swelling at the injection site. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.|During the 7-day follow-up period (Days 0 to 6) after any vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with the symptom sheet completed.||subjects|||Number
803751|NCT00985790|Secondary|Number of Seroprotected Subjects Against 4 Strains of Influenza Disease.|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the unprimed groups.|At Days 0, 28 and 56|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||subjects|||Number
803752|NCT00985790|Secondary|Number of Seroprotected Subjects Against 4 Strains of Influenza Disease.|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the primed groups.|At Days 0 and 28|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||subjects|||Number
803753|NCT00985790|Secondary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the unprimed groups.|At Days 28 and 56|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||fold increase||95% Confidence Interval|Geometric Mean
803754|NCT00985790|Secondary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the primed groups.|At Day 28|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||fold increase||95% Confidence Interval|Geometric Mean
803755|NCT00985790|Secondary|Number of Seroconverted Subjects Against 4 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the unprimed groups.|At Days 28 and 56|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||subjects|||Number
803756|NCT00985790|Secondary|Number of Seroconverted Subjects Against 4 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the primed groups.|At Day 28|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||subjects|||Number
803757|NCT00985790|Secondary|Number of Seropositive Subjects Against 4 Strains of Influenza Disease.|A seropositive subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:10. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the unprimed groups.|At Days 0, 28 and 56|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||subjects|||Number
803758|NCT00985790|Secondary|Number of Seropositive Subjects Against 4 Strains of Influenza Disease.|A seropositive subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:10. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the primed groups.|At Days 0 and 28|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||subjects|||Number
803759|NCT00985790|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. The 4 influenza strains assessed were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the unprimed groups.|At Days 0, 28 and Day 56|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||titers||95% Confidence Interval|Geometric Mean
803775|NCT00985985|Secondary|Mean Change From Baseline in Body Weight at Week 6, Week 12 and Week 24/ Premature Termination.|Change in body weight was analyzed at Weeks 6, 12, and 24.|Baseline, Week 6, 12 and Week 24|Analysis was carried out per FAS population, which consisted of all randomized subjects who had study medication for at least once with assessment data post-dosing. Due to drop outs, there was difference in the population analyzed (n) for this outcome measure at each time point i.e. Week 6, Week 12 and Week 24. Missing values were not imputed.||kilogram (kg)||Standard Deviation|Mean
803760|NCT00985790|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. The 4 influenza strains assessed were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the primed groups.|At Days 0 and 28.|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||titers||95% Confidence Interval|Geometric Mean
803761|NCT00985790|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the 3 Fluarix Vaccine Strains.|Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. The 3 influenza strains assessed were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2) and Flu B/Brisbane/60/08 Victoria (VICT).The POST results were the primary outcome variables.|At Day 0 [PRE] and at 28 days post last vaccination (Day 28 or Day 56) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||titers||95% Confidence Interval|Geometric Mean
803762|NCT00985946|Secondary|Evaluate the Overall Survival of Patients With Gastrointestinal Neuroendocrine Tumors Treated With Panobinostat||Up to 5 years|||months||90% Confidence Interval|Median
803763|NCT00985946|Secondary|Delineate the Expression of Notch 1 in Neuroendocrine Tumor Samples Before and During Treatment With Panobinostat|The expression of Notch 1 in neuroendocrine tumor samples will be evaluated prior to Cycle 1 Day 1 dose and at the end of Cycle 2 of treatment of treatment.|Pre-treatment and up to week 12|Data to delineate the expression of Notch 1 in neuroendocrine tumor samples was not collected. The question regarding the role of Notch1 in well-differentiated NET remains unanswered.|||||
803764|NCT00985946|Secondary|Evaluate the Time to Progression for Patients With Gastrointestinal Neuroendocrine Tumors Treated With Panobinostat||Up to 5 years|||months||90% Confidence Interval|Median
803765|NCT00985946|Secondary|Number of Participants With Toxicities|Evaluate the toxicity and tolerability of panobinostat in the patient population|up to 5 years|||participants|||Number
803766|NCT00985946|Primary|Tumor Response Rate of Patients With Gastrointestinal Neuroendocrine Tumors Using Response Evaluation Criteria in Solid Tumors (RECIST) Criteria.|Confirmed anti-tumor response rate will be validated by the Response Evaluation Criteria in Solid Tumors (RECIST). All participants included in the study will be assessed for response to the proposed panobinostat treatment, even if there are protocol treatment deviations. Each participant will be assigned one of the following categories: complete response, partial response, stable disease, progressive disease, early death from malignant disease, early death from toxicity, early death because of other cause, or unknown.|every 8 weeks, up to 5 years|||participants|||Number
803767|NCT00985959|Secondary|Median Time to First Response - Phase II|Time to first response is the duartion of time required to achieve first response to treatment|up to 54 weeks|Full analysis set: All participants who received at least one dose of the study medication.||Days||95% Confidence Interval|Median
803768|NCT00985959|Secondary|Maximum Observed Plasma Concentration (Cmax) of Prednisolone - Phase I|Cmax of Prednisolone at dose of 60 mg/m2 on Cycle 2/Day 4|Day 4 of Cycle 2|Pharmacokinetics-evaluable population: 14 participants were included in pharmacokinetics-evaluable population during Cycle 2||ng/mL||Standard Deviation|Mean
803769|NCT00985959|Secondary|Maximum Observed Plasma Concentration (Cmax) of Melphalan - Phase I|Cmax of melphalan at dose of 9 mg/m2 on Cycle 2/Day 4|Day 4 of Cycle 2|Pharmacokinetics-evaluable population: 14 participants were included in pharmacokinetics-evaluable population during Cycle 2||ng/mL||Standard Deviation|Mean
803770|NCT00985959|Secondary|Maximum Observed Plasma Concentration (Cmax) of Bortezomib (JNJ-26866138 in Combination With Melphalan and Prednisolone) - Phase I|Cmax of bortezomib following intravenous administration of JNJ-26866138 at dose of 0.7, 1.0, and 1.3 mg/m2 on Cycle 2/Day 4 (combination with melphalan and prednisolone)|Day 4 of Cycle 2|Pharmacokinetics-evaluable population: 14 participants were included in pharmacokinetics-evaluable population during Cycle 2||ng/mL||Standard Deviation|Mean
803771|NCT00985959|Secondary|Maximum Observed Plasma Concentration (Cmax) of Bortezomib (JNJ-26866138 Alone) - Phase I|Cmax of bortezomib following intravenous administration of JNJ-26866138 at dose of 0.7, 1.0, and 1.3 mg/m2 on Cycle 1/Day 25 (JNJ-26866138 alone)|Day 25 of Cycle 1|Pharmacokinetics-evaluable population: 16 participants were included in pharmacokinetics-evaluable population||ng/mL||Standard Deviation|Mean
803772|NCT00985959|Primary|Number of Participants With Overall Response (Complete Response [CR] + Partial Response [PR]) - Phase I and II|Response is evaluated as per the criteria for evaluating disease response and progression in patients with multiple myeloma treated by high-dose therapy and haemopoietic stem cell transplantation (Blade et al. 1998). CR: disappearance of the original monoclonal protein from the blood and urine and <5% plasma cells in the bone marrow on at least 2 determinations for a minimum of 6 weeks; no increase in the size or number of lytic bone lesions; disappearance of soft tissue plasmacytomas for at least 6 weeks. PR: ≥50% reduction in the level of serum monoclonal protein for at least 2 determinations 6 weeks apart; If present, reduction in 24-hour urinary light chain excretion by either ≥90% or to <200 mg for at least 2 determinations 6 weeks apart; ≥50% reduction in the size of soft tissue plasmacytomas for at least 6 weeks; no increase in size or number of lytic bone lesions|54 weeks|Full analysis set: All participants who received at least one dose of the study medication.||Participants|||Number
803773|NCT00985959|Primary|Number of Participants With Dose Limiting Toxicity During the Phase I (Cycle 1)|Dose limiting toxicity defined as an adverse event or adverse drug reaction experienced by the participants during 6 weeks of treatment Cycle 1|6 weeks|Dose Limiting Toxicity set, Which includes all 18 participants in the Phase I||Participants|||Number
803774|NCT00985985|Secondary|Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Cardiovascular AEs and Who Discontinued Due to AEs|All AEs and SAEs were reviewed and reported by investigator. AEs were graded on a 3-point scale as Mild, Moderate and Severe.|Weekly assessments from first treatment dose up to 15 days after last treatment dose|Safety Population of this study consists of all randomized participants who have had study medication for at least once.||Participants|||Number
835358|NCT01286805|Secondary|Narcotic Pain Medication Needed||Day of surgery prior to discharge|||equivalents milligrams oral morphine||Standard Deviation|Mean
803776|NCT00985985|Secondary|Mean Daily Dose at Visit 4, 5, 6, 7 and 10|Mean daily dose of lozenges was calculated as number of lozenges taken at each visit divided by days since the last visit.|Weeks 1-2, 3-4, 5-6, 7-12 and 13-24|Analysis was carried out per FAS population, which consisted of all randomized subjects who had study medication for at least once with assessment data post-dosing. Due to drop outs, there was difference in the population analyzed (n) for this outcome measure at each time point. Missing values were not imputed.||Number of lozenges||Standard Deviation|Mean
803777|NCT00985985|Secondary|Mean Score of Relief of Craving/ Total Withdrawal Symptoms|The evaluation of withdrawal and craving symptoms was carried out every day with the Minnesota Nicotine Withdrawal scale (MNWS). The MNWS total score contains 9 items (urge to smoke; depressed mood; irritability, frustration, or anger; anxiety; difficulty concentrating; restlessness; increased appetite; difficulty going to sleep; difficulty staying asleep). Each item was rated on a 5 grade scale with scores ranging from 0 (best score) to 4 (worst score) i.e. none (score=0), slight (score=1), mild (score=2), moderate (score=3), and severe (score=4). For each symptom at each week, the average score was calculated as the average of the daily scores during that week. The total score was calculated as the sum of the 9 symptoms.|Weekly assessment at Week 1, 2, 3, 4, 5 and Week 6|Analysis was carried out per FAS population, which consisted of all randomized subjects who have had study medication for at least once with assessment data post-dosing. Due to drop outs, there was difference in the number of participants analyzed (n) for this outcome measure. Missing values were not imputed.||Score on a scale||Standard Deviation|Mean
803778|NCT00985985|Secondary|Proportion of Participants With Seven Day Point Prevalence Abstinence|Seven day point prevalence abstinence was defined as complete abstinence from smoking for the 7 days up to and including the evaluation day.|Weekly assessment at Week 1, 2, 4, 6, 12 and Week 24|Analysis was carried out per FAS population. FAS population consisted of all randomized subjects who had study medication for at least once with assessment data post-dosing.||Percentage of participants|||Number
803779|NCT00985985|Secondary|Rate of Long-term Successful Smoking Cessation at Week 24|Rate of long-term successful smoking cessation at Week 24 was defined as the proportion of participants who achieved the primary end-point with no more than six cumulative days of smoking from Week 6 to Week 24.|From Week 6 to Week 24|Analysis was done per FAS population. FAS population consisted of all randomized subjects who had study medication for at least once with assessment data post-dosing.||Percentage of participants|||Number
803780|NCT00985985|Secondary|Rate of Continuous Successful Smoking Cessation at Week 12 and Week 24|Continuous abstinence was verified by measurement of CO breath levels.|From baseline to Week 12 and Week 24|Analysis was done per FAS population. FAS population consisted of all randomized subjects who had study medication for at least once with assessment data post-dosing.||Percentage of participants|||Number
803781|NCT00985985|Primary|Rate of Successful Smoking Cessation at Week 6|Rate of Successful Smoking Cessation at Week 6 was measured by Carbon Monoxide (CO) breath levels.|From baseline to Week 6|Analysis was considered per Full Analysis Set (FAS) population. FAS population consisted of all randomized participants who had study medication for at least once with assessment data post-dosing.||Percentage of participants|||Number
803782|NCT00986102|Secondary|Number of Participants Readmitted to the Hospital Within 28 Days After End-of-treatment (EOT)||Within 28 days after EOT (Day 5 or Day 7 or Day 14)|Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication.||Participants|||Number
803783|NCT00986102|Secondary|Number of Participants Readmitted to the Intensive Care Unit (ICU) Within 28 Days After End-of-treatment (EOT)||Within 28 days after EOT (Day 5 or Day 7 or Day 14)|Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication.||Participants|||Number
803784|NCT00986102|Secondary|Medical Resource Utilization|Medical resource utilization included length of hospital stay, length of intensive care unit (ICU) stay, duration of mechanical ventilation and time to discharge.|From Baseline (Day -1) upto the duration of hospital stay of a participant|Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication.||Days||Full Range|Median
803785|NCT00986102|Secondary|Number of Participants Who Experienced Eradication, Presumed Eradication, Persistence, Presumed Persistence and Indeterminate Response at End-of-treatment Visit (EOT) Visit||Day 5 or Day 7 or Day 14|Microbiological Modified Intent-to-Treat Population (mMITT): included participants who had a baseline pathogen identified, regardless of susceptibility to study medication.||Participants|||Number
803786|NCT00986102|Secondary|Number of Participants Who Achieved Clinical Cure, or Experienced Clinical Failure, Relapse or Intermediate Outcome at Test-of-cure (TOC) Visit||End-of-treatment (Day 5 or Day 7 or Day 14) plus 7 to 14 days|Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication.||Participants|||Number
803787|NCT00986102|Secondary|Number of Participants Who Achieved Clinical Cure, Clinical Failure and Intermediate Outcome at End-of-treatment Visit (EOT)||Day 5 or Day 7 or Day 14|Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication.||Participants|||Number
803788|NCT00986102|Primary|Number of Participants With Acute Physiology and Chronic Health Evaluation II (APACHE II) Score|APACHE II is a severity of disease classification system and the score will be determined in the participants admitted to the Intensive Care Unit upon study enrollment to help predict the risk of mortality for critically ill patients. It consists of, A: acute physiology score (APS; range, 0 to 4), B: age points (range, 0 [less than or equal to 44] to 6 [greater than or equal to 75]) and C: chronic health points (2 [elective postoperative patient] and 5 [non-operative or emergency postoperative patient]). Total APACHE II score is sum of A, B and C.|Baseline (Day -1)|Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication.||Participants|||Number
803789|NCT00986102|Primary|Duration of Antibiotic Therapy|Duration of doripenem and duration of doripenem plus oral antibiotics therapy|5 to 14 days|Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication.||Days||Standard Deviation|Mean
803790|NCT00986102|Primary|Number of Participants With Different Mode of Usage of Doripenem||5 to 14 days|Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication.||Participants|||Number
803793|NCT00986154|Secondary|The Composite Clinical Outcome of Symptomatic Recurrent VTE and All-cause Mortality||12 months from time of randomization|mITT Analysis set||number of participants with event|||Number
803794|NCT00986154|Primary|Symptomatic Recurrent VTE, i.e., the Composite of DVT, Non-fatal PE, and Fatal PE|"Symptomatic recurrent Venous Thromboembolism (VTE), i.e., the composite of deep Vein Thrombosis (DVT), non-fatal Pulmonary Embolism (PE), and fatal PE occurring during the Overall Study Period.
Overall Study Period defined as The time from the reference date (randomization date/initial dose of study drug date) to the last study follow-up visit."|12 months from time of randomization|(mITT) modified Intent To Treat Analysis Set||number or participants with an event|||Number
803795|NCT00986180|Secondary|Kaplan-Meier First Time to 50% Response From Baseline for Low Back Pain|50% response means >= 50% reduction from baseline in low back pain intensity score.|Day 0 and Day 10/last visit|Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).||Hours||95% Confidence Interval|Median
803796|NCT00986180|Secondary|Kaplan-Meier First Time to 30% Response From Baseline for Low Back Pain|30% response means >= 30% reduction from baseline in low back pain intensity score.|Day 0 and Day 10/last visit|Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).||Hours||95% Confidence Interval|Median
803797|NCT00986180|Secondary|Summary of Subjects Having Pruritus as a Treatment-Emergent Adverse Event|Number of subjects that reported pruritus as a treatment emergent adverse event during the study.|Day 0 and Day 10/last visit|Safety Population: all randomized subjects who take at least 1 dose of study drug.||Participants|||Number
803798|NCT00986180|Secondary|Summary of Subjects Having Constipation as a Treatment-Emergent Adverse Event|Number of subjects that reported constipation as a treatment emergent adverse event during the study.|Day 0 and Day 10/last visit|Safety Population: all randomized subjects who take at least 1 dose of study drug.||Participants|||Number
803799|NCT00986180|Secondary|Summary of Subjects Having Vomiting as a Treatment-Emergent Adverse Event|Number of subjects that reported vomiting as a treatment emergent adverse event during the study.|Day 0 and Day 10/last visit|Safety Population: all randomized subjects who take at least 1 dose of study drug.||Participants|||Number
803800|NCT00986180|Secondary|Summary of Subjects Having Nausea as a Treatment-Emergent Adverse Event|Number of subjects that reported nausea as a treatment-emergent adverse event during the study.|Day 0 and Day 10/last visit|Safety Population: all randomized subjects who take at least 1 dose of study drug.||Participants|||Number
803801|NCT00986180|Secondary|Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation||Day 0 and Day 10/last visit|Safety Population: all randomized subjects who take at least 1 dose of study drug.||Participants|||Number
803802|NCT00986180|Secondary|Incidence of 50% Responders Without Nausea or Vomiting at Day 5|Number of subjects had ≥ 50% reduction from baseline in low back pain intensity without nausea or vomiting reported.|Day 0 and Day 5|Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).||Participants|||Number
803803|NCT00986180|Secondary|Incidence of 30% Responders Without Nausea or Vomiting at Day 5|Number of subjects had ≥ 30% reduction from baseline in low back pain intensity without nausea or vomiting reported.|Day 0 and Day 5|Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).||Participants|||Number
803804|NCT00986180|Secondary|Satisfaction With Treatment at End of Study|The subject’s satisfaction with treatment was assessed using a 7-point scale (1=Very satisfied, 2=Somewhat satisfied, 3=Slightly satisfied, 4=Neither satisfied nor dissatisfied, 5=Slightly dissatisfied, 6=Somewhat dissatisfied, 7=Very dissatisfied).|Day 0 and Day 10/last visit|Intent-To-Treat Population with subject's satisfaction assessment at end of the study.||Units on a Scale||Standard Deviation|Mean
803805|NCT00986180|Secondary|Satisfaction With Treatment at End of Study|The subject’s satisfaction with treatment was assessed using a 7-point scale (1=Very satisfied, 2=Somewhat satisfied, 3=Slightly satisfied, 4=Neither satisfied nor dissatisfied, 5=Slightly dissatisfied, 6=Somewhat dissatisfied, 7=Very dissatisfied).|Day 0 and Day 10/last visit|Intent-To-Treat Population.||Units on a Scale|||Number
803806|NCT00986180|Secondary|Satisfaction With Treatment at Day 5|The subject’s satisfaction with treatment was assessed using a 7-point scale (1=Very satisfied, 2=Somewhat satisfied, 3=Slightly satisfied, 4=Neither satisfied nor dissatisfied, 5=Slightly dissatisfied, 6=Somewhat dissatisfied, 7=Very dissatisfied).|Day 0 and Day 5|Intent-To-Treat Population with subject's satisfaction assessment on Day 5.||Units on a Scale||Standard Deviation|Mean
803807|NCT00986180|Secondary|Satisfaction With Treatment at Day 5|The subject’s satisfaction with treatment was assessed using a 7-point scale (1=Very satisfied, 2=Somewhat satisfied, 3=Slightly satisfied, 4=Neither satisfied nor dissatisfied, 5=Slightly dissatisfied, 6=Somewhat dissatisfied, 7=Very dissatisfied).|Day 0 and Day 5|Intent-To-Treat Population.||Units on a Scale|||Number
803808|NCT00986180|Secondary|Clinician Global Impression of Change at End of Study|Clinician Global Impression of Change (CGIC) assesses the subject’s global improvement since starting study treatment using a 7-point NRS (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse).|Day 0 and Day 10/last visit|Intent-To-Treat Population with CGIC assessment.||Units on a Scale||Standard Deviation|Mean
803809|NCT00986180|Secondary|Clinician Global Impression of Change at End of Study|Clinician Global Impression of Change (CGIC) assesses the subject’s global improvement since starting study treatment using a 7-point NRS (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse).|Day 0 and Day 10/last visit|Intent-To-Treat Population.||Units on a Scale|||Number
803810|NCT00986180|Secondary|Patient Global Impression of Change at End of Study|Patient Global Impression of Change (PGIC) assesses the subject’s global improvement since starting study treatment using a 7-point NRS (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse).|Day 0 and Day 10/lst visit|Intent-To-Treat Population with PGIC assessment.||Units on a Scale||Standard Deviation|Mean
805727|NCT01005719|Secondary|Percentage of Time Intragastric is pH >4 Over 24-hour Period on Day 7||Treatment dose to 24-hour post-dose on Day 7|Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.||Percentage of time||Full Range|Median
803811|NCT00986180|Secondary|Patient Global Impression of Change at End of Study|Patient Global Impression of Change (PGIC) assesses the subject’s global improvement since starting study treatment using a 7-point NRS (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse).|Day 0 and Day 10/last visit|Intent-To-Treat Population.||Units on a Scale|||Number
803812|NCT00986180|Secondary|SF-MPQ-2 – Change From Baseline Values: Subscale and Total Scores - Total Score Day 10/Last Visit|Short-Form McGill Pain Questionnaire – 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). The total SF-MPQ-2 scale score is calculated as the mean of all 22 items. The range of the total score is 0 to 10.|Day 0 and Day 10|Intent-To-Treat Population with both baseline and Day 10 SF-MPQ-2 measurements.||Units on a Scale||Standard Deviation|Mean
803813|NCT00986180|Secondary|SF-MPQ-2 – Change From Baseline Values: Subscale and Total Scores - Total Score Day 5|Short-Form McGill Pain Questionnaire – 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). The total SF-MPQ-2 scale score is calculated as the mean of all 22 items. The range of the total score is 0 to 10.|Day 0 and Day 5|Intent-To-Treat Population and have both baseline and Day 5 SF-MPQ-2 measurements.||Units on a Scale||Standard Deviation|Mean
803814|NCT00986180|Secondary|SF-MPQ-2 – Change From Baseline Values: Subscale and Total Scores - Affective Descriptors Day 10/Last Visit|Short-Form McGill Pain Questionnaire – 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Affective subscale descriptors include: tiring-exhausting, sickening, fearful, and punishing-cruel.|Day 0 and Day 10|Intent-To-Treat Population and have both baseline and Day 10 SF-MPQ-2 measurements.||Units on a Scale||Standard Deviation|Mean
803815|NCT00986180|Secondary|SF-MPQ-2 – Change From Baseline Values: Subscale and Total Scores - Affective Descriptors Day 5|Short-Form McGill Pain Questionnaire – 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Affective subscale descriptors include: tiring-exhausting, sickening, fearful, and punishing-cruel.|Day 0 and Day 5|Intent-To-Treat Population and have both baseline and Day 5 SF-MPQ-2 measurements.||score of scale||Standard Deviation|Mean
803816|NCT00986180|Secondary|SF-MPQ-2 – Change From Baseline Values: Subscale and Total Scores - Neuropathic Pain Day 10/Last Visit|Short-Form McGill Pain Questionnaire – 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Predominantly neuropathic pain subscale descriptors include: hot-burning pain, cold-freezing pain, pain caused by light touch, itching, tingling or “pins and needles” and numbness.|Day 0 and Day 10|Intent-To-Treat Population and have both baseline and Day 10 SF-MPQ-2 measurements.||Units on a Scale||Standard Deviation|Mean
803817|NCT00986180|Secondary|SF-MPQ-2 – Change From Baseline Values: Subscale and Total Scores - Neuropathic Pain Day 5|Short-Form McGill Pain Questionnaire – 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Predominantly neuropathic pain subscale descriptors include: hot-burning pain, cold-freezing pain, pain caused by light touch, itching, tingling or “pins and needles” and numbness.|Day 0 and Day 5|Intent-To-Treat Population and have both baseline and Day 5 SF-MPQ-2 measurements.||Units on a Scale||Standard Deviation|Mean
803818|NCT00986180|Secondary|SF-MPQ-2 – Change From Baseline Values: Subscale and Total Scores - Intermittent Pain Day 10/Last Visit|Short-Form McGill Pain Questionnaire – 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Intermittent pain subscale descriptors include: shooting pain, stabbing pain, sharp pain, splitting pain, electric-shock pain, and piercing.|Day 0 and Day 10|Intent-To-Treat Population and have both baseline and Day 10 SF-MPQ-2 measurements.||Units on a Scale||Standard Deviation|Mean
803819|NCT00986180|Secondary|SF-MPQ-2 – Change From Baseline Values: Subscale and Total Scores - Intermittent Pain Day 5|Short-Form McGill Pain Questionnaire – 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Intermittent pain subscale descriptors include: shooting pain, stabbing pain, sharp pain, splitting pain, electric-shock pain, and piercing.|Day 0 and Day 5|Intent-To-Treat Population and have both baseline and Day 5 SF-MPQ-2 measurements.||Units on a Scale||Standard Deviation|Mean
803820|NCT00986180|Secondary|SF-MPQ-2 – Change From Baseline Values: Subscale and Total Scores - Continuous Pain Day 10/Last Visit|Short-Form McGill Pain Questionnaire – 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Continuous pain subscale descriptors include: throbbing pain, cramping pain, gnawing pain, aching pain, heavy pain, and tender.|Day 0 and Day 10|Intent-To-Treat Population and have both baseline and Day 10 SF-MPQ-2 measurements.||Units on a Scale||Standard Deviation|Mean
803831|NCT00986232|Secondary|Antibody Response to Rubella at 6 Weeks Postvaccination in Participants Initially Seronegative to Rubella at Baseline - Geometric Mean Titer (GMT)|Postvaccination observed Geometric Mean Titer (GMT) of Rubella antibody. (Titers measured using Rubella ELISA.)|6 weeks postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.||mcg/mL||95% Confidence Interval|Geometric Mean
812470|NCT01070784|Primary|Clinical Laboratory Test: Haematology -Eosinophils|Change from baseline|Baseline and 52 week after|||percentage of Eosinophils||Standard Deviation|Mean
803821|NCT00986180|Secondary|SF-MPQ-2 – Change From Baseline Values: Subscale and Total Scores - Continuous Pain Day 5|Short-Form McGill Pain Questionnaire – 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Continuous pain subscale descriptors include: throbbing pain, cramping pain, gnawing pain, aching pain, heavy pain, and tender.|Day 0 and Day 5|Intent-To-Treat Population (all randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain) and have both baseline and Day 5 SF-MPQ-2 measurement||Units on a Scale||Standard Deviation|Mean
803822|NCT00986180|Secondary|Total Pain Relief (TOTPAR) for Low Back Pain – Summary Statistics at 5 Days|Pain Relief – 5-Point Numerical Rating Scale, 0=None, 4=Complete. Total Pain Relief (TOTPAR) is a weighted sum of pain relieve over a specified time period, say 5 days.|Day 0 and Day 5|Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).||Units on a Scale||Standard Error|Least Squares Mean
803823|NCT00986180|Secondary|SPID for Index Leg Pain – Summary Statistics at 10 Days (With Imputation)|Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 10 days.|Day 0 and Day 10|Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).||Units on a Scale||Standard Error|Least Squares Mean
803824|NCT00986180|Secondary|SPID for Index Leg Pain – Summary Statistics at 5 Days (With Imputation)|Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 5 days.|Day 0 and Day 5|Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).||Units on a Scale||Standard Error|Least Squares Mean
803825|NCT00986180|Secondary|SPID for Index Leg Pain – Summary Statistics at 3 Days (With Imputation)|Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 3 days.|Day 0 and Day 3|Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).||Units on a Scale||Standard Error|Least Squares Mean
803826|NCT00986180|Secondary|SPID for Index Leg Pain – Summary Statistics at 2 Days (With Imputation)|Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 2 days.|Day 0 and Day 2|Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).||Units on a Scale||Standard Error|Least Squares Mean
803827|NCT00986180|Secondary|SPID for Low Back Pain – Summary Statistics at 10 Days (With Imputation)|Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 10 days.|Day 0 and Day 10|Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).||Units on a scale||Standard Error|Least Squares Mean
803828|NCT00986180|Secondary|SPID for Low Back Pain – Summary Statistics at 3 Days (With Imputation)|Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 3 days.|Day 0 and Day 3|Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).||Units on a scale||Standard Error|Least Squares Mean
803829|NCT00986180|Secondary|Sum of Pain Intensity Difference (SPID) for Low Back Pain – Summary Statistics at 2 Days (With Imputation)|Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 2 days.|Day 0 and Day 2|Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).||Units on a Scale||Standard Error|Least Squares Mean
803830|NCT00986180|Primary|Sum of Pain Intensity Difference (SPID) for Low Back Pain – Summary Statistics at 120 Hours (With Imputation)|Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 120 hours.|0 hour (prior to first dose) and 120 hours|Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).||Units on a scale||Standard Error|Least Squares Mean
803873|NCT00986349|Other Pre-specified|Fasting Plasma Glucose Over Time for All Subjects||Baseline to 12 months post Device Explant|Subjects with a Successful Device Implant Procedure||mmol/L||Full Range|Median
803874|NCT00986349|Secondary|Total Weight Change (kg) at Week 52 Compared to Baseline Weight||Baseline to 52 weeks|||kg||Standard Deviation|Mean
803832|NCT00986232|Secondary|Antibody Response to Mumps at 6 Weeks Postvaccination in Participants Initially Seronegative to Mumps at Baseline - Geometric Mean Titer (GMT)|Postvaccination observed Geometric Mean Titer (GMT) of Mumps antibody. (Titer measured using Mumps ELISA.)|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.||mcg/mL||95% Confidence Interval|Geometric Mean
803833|NCT00986232|Secondary|Antibody Response to Measles at 6 Weeks Postvaccination in Participants Initially Seronegative to Measles at Baseline - Geometric Mean Titer (GMT)|Postvaccination observed Geometric Mean Titer (GMT) of Measles antibody. (Titers measured using Measles ELISA.)|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.||mcg/mL||95% Confidence Interval|Geometric Mean
803834|NCT00986232|Secondary|Antibody Response to Varicella at 6 Weeks Postvaccination in Participants With Baseline Titer < 1.25 gpELISA Units - Geometric Mean Titer (GMT)|Postvaccination observed Geometric Mean Titer (GMT) of Varicella antibody. (Titers measured using Varicella zoster virus (VZV) gpELISA.)|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.||mcg/mL||95% Confidence Interval|Geometric Mean
803835|NCT00986232|Secondary|Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences (CAEs)|Participants with a serious vaccine-related CAE (an AE which is assessed by an investigator/qualified physician as being related to study vaccine and results in death, persistent or significant disability/incapacity, prolongs an existing inpatient hospitalization, is life-threatening, a congenital anomaly/birth defect, a cancer, or an overdose).|6 weeks Postvaccination Visit 1 or Visit 2|All participants with follow-up for safety were included in the analysis.||Participants|||Number
803836|NCT00986232|Secondary|Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥ 10 IU/mL|Antibody response to Rubella at 6 weeks postvaccination in participants initially seronegative (a titer <10 IU/mL) to Rubella at baseline|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges, were seronegative to rubella at baseline, and followed protocol procedures.||Participants|||Number
803837|NCT00986232|Secondary|Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥ 2.0 Ab Units/mL|Antibody response to Mumps at 6 weeks postvaccination in participants initially seronegative (a titer < 2.0 Ab units/mL) to Mumps at baseline|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges, were seronegative to mumps at baseline, and followed protocol procedures.||Participants|||Number
803838|NCT00986232|Secondary|Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥ 207.5 mIU/mL|Antibody response to measles at 6 weeks postvaccination in participants initially seronegative (a titer <207.5 mIU/mL) to measles at baseline|6 weeks postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges, were seronegative to measles at baseline, and followed protocol procedures.||Participants|||Number
803839|NCT00986232|Primary|Number of Participants With Varicella Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Antibody Titer ≥ 5 gpELISA Units|Antibody response to Varicella at 6 weeks postvaccination in participants with baseline titer <1.25 gpELISA units|6 weeks postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges, were seronegative to varicella at baseline, and followed protocol procedures.||Participants|||Number
803840|NCT00986245|Secondary|Patients Who Have Global Impression for Improvement to Severity of Dyskinesia|Patients who have Global Impression for Improvement to Severity of Dyskinesia compared|After 8 weeks in each arm or at last visit for early completion|The number of patient who completed the study and answered the questionnaire for global impression to dyskinesia severity.||participants|||Number
803841|NCT00986245|Secondary|Patients Who Have Global Impression for Improvement to Duration of Dyskinesia|Patients who have global impression for improvement to duration of dyskinesia compared|After 8 weeks in each arm or at last visit for early completion|The number of patient who completed the study and answered the questionnaire for global impression to dyskinesia duration.||participants|||Number
803842|NCT00986245|Secondary|Patients Who Have Global Impression for Improvement to Severity of Motor Fluctuation|Patients who have global impression for improvement to severity of motor fluctuation compared|After 8 weeks in each arm or at last visit for early completion|The number of patient who completed the study and answered the questionnaire for global impression to motor fluctuation severity.||participants|||Number
803843|NCT00986245|Secondary|Patients Who Have Global Impression for Improvement to Duration of Motor Fluctuation|Patients who have global impression for improvement to duration of motor fluctuation|After 8 weeks in each arm or at last visit for early completion|The number of patient who completed the study and answered the questionnaire for global impression to motor fluctuation duration.||participants|||Number
803844|NCT00986245|Secondary|Patients Who Have Global Impression for Improvement|Patients who have global impression for improvement for each dosing.|After 8 weeks in each arm or at last visit for early completion|The number of patient who completed the study and answered the questionnaire for global impression.||participants|||Number
803845|NCT00986245|Secondary|Adverse Events|Patients who have adverse events|After 8 weeks in each arm or at last visit for early completion|Total number of patients are 61 (Group 1 + Group 2), because of Crossover design. QD or BID arm means clinical variables measured in once-daily or twice-daily regimen, respectively.||participants|||Number
803846|NCT00986245|Secondary|Compliance|Compliances after 8 weeks in each arm or at last visit for early completion. Compliance was calcuated by the percentage of used medication.|8 weeks for each arm or at last visit|Total number of patients are 61 (Group 1 + Group 2), because of Crossover design. QD or BID arm means clinical variables measured in once-daily or twice-daily regimen, respectively.||percentage of used medication||Standard Deviation|Mean
803847|NCT00986245|Secondary|Epworth Sleep Scale|"Epworth sleep scale after 8 weeks in each arm or at last visit for early completion.
Range: 0~24 Higher values represent worse daytime-sleepiness."|8 weeks in each arm or at last visit for early completion|Total number of patients are 61 (Group 1 + Group 2), because of Crossover design. QD or BID arm means clinical variables measured in once-daily or twice-daily regimen, respectively.||units on a scale||Standard Deviation|Mean
803848|NCT00986245|Secondary|Early Morning Off Symptoms|"Sleep questionnaire 3 for early morning off symptoms Visual analogue scale: 0~10 Higher values represent worse early morning off symptoms."|8 weeks for each arm or at last visit|Total number of patients are 61 (Group 1 + Group 2), because of Crossover design. QD or BID arm means clinical variables measured in once-daily or twice-daily regimen, respectively.||units on a scale||Standard Deviation|Mean
803849|NCT00986245|Secondary|Nocturnal Off-symptoms|"Sleep questionnaire 2 for Nocturnal off-symptoms Visual analogue scale: 0~10 Higher values represent worse nocturnal off-symptoms."|8 weeks for each arm or at last visit|Total number of patients are 61 (Group 1 + Group 2), because of Crossover design. QD or BID arm means clinical variables measured in once-daily or twice-daily regimen, respectively.||units on a scale||Standard Deviation|Mean
803850|NCT00986245|Secondary|Overall Quality of Sleep|"Sleep questionnaire 1 for Overall quality of sleep Visual analogue scale: 0~10 Higher values represent worse overall sleep quality."|8 weeks for each arm or at last visit|Total number of patients are 61 (Group 1 + Group 2), because of Crossover design. QD or BID arm means clinical variables measured in once-daily or twice-daily regimen, respectively.||units on a scale||Standard Deviation|Mean
803851|NCT00986245|Secondary|Hoehn and Yahr Stage|Hoehn and Yahr(HY) stage for parkinsonism after 8 weeks in each arm or at last visit for early completion Range: 0~5 Higher values represent more severe parkinsonism|8 weeks for each arm or at last visit|Total number of patients are 61 (Group 1 + Group 2), because of Crossover design. Once-daily or twice-daily arm means clinical variables measured in once-daily or twice-daily regimen, respectively.||Scores on a scale||Standard Deviation|Mean
803852|NCT00986245|Secondary|Unified Parkinson's Disease Rating Scale, Part 3|"Unified Parkinson's disease rating scale (UPDRS) motor scale after 8 weeks in each arm or at last visit for early completion.
UPDRS part 3 is motor scale for parkinson's disease. Range: 0~108 Higher values represent more severe motor symptoms of parkinsonism."|8 weeks for each arm or at last visit|Total number of patients are 61 (Group 1 + Group 2), because of Crossover design. Once-daily or Twice-daily arm means clinical variables measured in once-daily or twice-daily regimen, respectively.||units on a scale||Standard Deviation|Mean
803853|NCT00986245|Primary|Patient Preference|Patient preference between once-daily and twice-daily regimen|After 16 weeks or at last visit for early completion|"Primary outcome measure was the preference of the subjects between once-daily versus twice-daily of RPR at the completion or at early completion after crossover.
61 of participants completing period with study intervention."||participants|||Number
803854|NCT00986258|Secondary|painDETECT Assessment for Participants After 12 Weeks of Tapentadol Prolonged Release Treatment|"The baseline painDETECT score was reassessed at the end of Week 12.
It is a participant completed questionnaire. A total score is calculated. Participants with a score between 0 and 12 are scored as being negative (no neuropathic pain component). Value between 19 and 38 as being positive (presence of neuropathic component). Values from 13 to 18 are scored as being unclear."|End of Week 12|Intention to treat (ITT).||units on a scale||Standard Deviation|Mean
803855|NCT00986258|Secondary|painDETECT Assessment for Participants After 6 Weeks of Tapentadol Prolonged Release Treatment|"The baseline painDETECT score was reassessed at the end of Week 6.
It is a participant completed questionnaire. A total score is calculated. Participants with a score between 0 and 12 are scored as being negative (no neuropathic pain component). Value between 19 and 38 as being positive (presence of neuropathic component). Values from 13 to 18 are scored as being unclear."|End of Week 6|Intention to treat (ITT).||units on a scale||Standard Deviation|Mean
803856|NCT00986258|Secondary|painDETECT Assessment at Baseline|"The painDETECT questionnaire was used to determine the possibility of the presence of a neuropathic pain component. It is a participant completed questionnaire. A total score is calculated. Participants with a score between 0 and 12 are scored as being negative (no neuropathic pain component). Value between 19 and 38 as being positive (presence of neuropathic component). Values from 13 to 18 are scored as being unclear."|Baseline|Intention to treat (ITT).||units on a scale||Standard Deviation|Mean
803857|NCT00986258|Secondary|Mean Equipotency Ratio of Tapentadol Compared to Hydromorphone|Tapentadol was compared to Hydromorphone with Hydromorphone set to 1. The average total daily dose of Tapentadol at which a pain score equivalent or below to the pain score at the end of observation period under Hydromorphone was reached was documented as the equipotent or equianalgesic dose to the total daily dose of the previously used Hydromorphone.|Baseline; End of Week 6 (6 Weeks)|Intention to treat (ITT). 8 participants with previous hydromorphone treatment.||Ratio|||Number
803858|NCT00986258|Secondary|Mean Equipotency Ratio of Tapentadol Compared to Morphine|Tapentadol was compared to Morphine with Morphine set to 1. The average total daily dose of Tapentadol at which a pain score equivalent or below to the pain score at the end of observation period under Morphine was reached was documented as the equipotent or equianalgesic dose to the total daily dose of the previously used Morphine.|Baseline; End of Week 6 (6 Weeks)|Intent to treat (ITT). 14 participants with previous morphine treatment.||Ratio|||Number
803859|NCT00986258|Secondary|Mean Equipotency Ratio of Tapentadol Compared to Fentanyl|Tapentadol was compared to Transdermal Fentanyl with Fentanyl set to 1. The average total daily dose of Tapentadol at which a pain score equivalent or below to the pain score at the end of observation period under Transdermal Fentanyl was reached was documented as the equipotent or equianalgesic dose to the total daily dose of the previously used Fentanyl.|Baseline; End of Week 6 (6 Weeks)|Intent to treat (ITT). 22 participants with previous transdermal fentanyl treatment.||Ratio|||Number
803860|NCT00986258|Secondary|Mean Equipotency Ratio of Tapentadol Compared to Buprenorphine|Tapentadol was compared to Buprenorphine with Buprenorphine set to 1. The average total daily dose of Tapentadol at which a pain score equivalent or below to the pain score at the end of observation period under Buprenorphine was reached was documented as the equipotent or equianalgesic dose to the total daily dose of the previously used Buprenorphine.|Baseline; End of Week 6 (6 Weeks)|Intention to treat (ITT). 24 participants with previous buprenorphine treatment.||Ratio|||Number
803861|NCT00986258|Secondary|Mean Equipotency Ratio of Tapentadol Compared to Oxycodone|Tapentadol was compared to Oxycodone with Oxycodone set to 1. The average total daily dose of Tapentadol at which a pain score equivalent or below to the pain score at the end of observation period under Oxycodone was reached was documented as the equipotent or equianalgesic dose to the total daily dose of the previously used Oxycodone.|Baseline; End of Week 6 (6 Weeks)|Intention to treat (ITT). 35 participants with previous oxycodone treatment.||Ratio|||Number
812471|NCT01070784|Primary|Clinical Laboratory Test: Haematology -Platelet Count|Change from baseline|Baseline and 52 week after|||*10000/μl||Standard Deviation|Mean
803862|NCT00986258|Secondary|Neuropathic Pain Symptom Inventory (NPSI) Sub-scores and Overall Score|"All participants were requested to complete the NPSI (Neuropathic Pain Symptom Inventory) questionnaire at this visit. Each participant rated their own neuropathic pain symptoms by answering ten questions relating to neuropathic symptoms on an 11-point scale 0 (not present) to 10 (worst imaginable) for each question. The higher the score for a question (sub-scale) the more bothersome the symptom is for the participant.
Results are reported as the mean (average) for each neuropathic symptom in a sub-scale.
The mean score is reported on a scale of 0 (not present in the group) to 1 (symptom has the maximum imaginable intensity for the whole group)."|End of Week 12|Intention to treat (ITT).||units on a scale||Standard Deviation|Mean
803863|NCT00986258|Secondary|Neuropathic Pain Symptom Inventory (NPSI) Sub-scores and Overall Score|"All participants were requested to complete the NPSI (Neuropathic Pain Symptom Inventory) questionnaire at this visit. Each participant rated their own neuropathic pain symptoms by answering ten questions relating to neuropathic symptoms on an 11-point scale 0 (not present) to 10 (worst imaginable) for each question. The higher the score for a question (sub-scale) the more bothersome the symptom is for the participant.
Results are reported as the mean for each neuropathic symptom in a sub-scale. The mean score is reported on a scale of 0 (not present in the group) to 1 (symptom has the maximum imaginable intensity for the whole group)."|End of Week 6|"Intention to treat (ITT).
For the sub-scores Overall Score and Pressing Pain there were only 60 participants with data available at Visit 6."||units on a scale||Standard Deviation|Mean
803864|NCT00986258|Secondary|Neuropathic Pain Symptom Inventory (NPSI) Sub-scores and Overall Score|"All participants were requested to complete the NPSI (Neuropathic Pain Symptom Inventory) questionnaire at this visit. Each participant rated their own neuropathic pain symptoms by answering ten questions relating to neuropathic symptoms on an 11-point scale 0 (not present) to 10 (worst imaginable) for each question. The higher the score for a question (sub-scale) the more bothersome the symptom is for the participant.
Results are reported as the mean for each neuropathic symptom in the sub-scale. The mean score is reported on a scale of 0 (not present in the group) to 1 (symptom has the maximum imaginable intensity for the whole group)."|Baseline|"Intention to treat (ITT).
For the sub-scores Overall Score and Pressing Pain there were only 69 participants with data available at baseline."||units on a scale||Standard Deviation|Mean
803865|NCT00986258|Secondary|Change in the Health Survey Scores Form (SF-36)|The Scores Form 36 (SF-36) includes several brief questions on 8 aspects, (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. A higher score indicates an improvement in health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state. A positive mean value indicates an improvement from baseline.|Baseline; End of Week 12 (12 Weeks)|"Intention to Treat (ITT).
For the sub-scores Role Emotional and Role Physical, there were only 91 participants with data available for the change of these sub-scores from baseline to visit 12."||units on a scale||Standard Deviation|Mean
803866|NCT00986258|Secondary|Change in the Health Survey Scores Form (SF-36)|The Scores Form 36 (SF-36) includes several brief questions on 8 aspects, (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. A higher score indicates an improvement in health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state. A positive mean value indicates an improvement from baseline.|Baseline; End of Week 6 (6 Weeks)|"Intention to treat (ITT).
For the sub-scores Role Emotional and Role Physical there were 98 participants, for sub-scores Physical Functioning, Vitality and Mental Health there were 99 participants, for sub-score General Health there were 100 participants with data available for the change of these sub-scores from baseline to visit 6."||units on a scale||Standard Deviation|Mean
803867|NCT00986258|Secondary|Patient Global Impression of Change|In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant is requested to choose one of seven categories. Scores range from very much improved to very much worse.|Baseline; End of Week 12 (12 Weeks)|Intention to treat (ITT)||participants|||Number
803868|NCT00986258|Secondary|Patient Global Impression of Change|In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant is requested to choose one of seven categories. Scores range from very much improved to very much worse.|Baseline; End of Week 6 (6 Weeks)|Intention to treat (ITT)||participants|||Number
803869|NCT00986258|Secondary|Change in Average Pain Intensity After 12 Weeks of Tapentadol Prolonged Release Treatment.|"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. The value indicates the change from the baseline value on the 0 to 10 scale. A Negative value indicates a reduction in pain intensity from the baseline average pain intensity."|Baseline; End of Week 12 (12 weeks)|Intention to treat (ITT).||units on a scale||Standard Deviation|Mean
803870|NCT00986258|Secondary|Change in Average Pain Intensity After 6 Weeks of Tapentadol Prolonged Release Treatment.|"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. The value indicates the change from the baseline value on the 0 to 10 scale. A negative value indicates a reduction in pain intensity from the baseline average pain intensity."|Baseline; End of Week 6 (6 weeks)|Intention to treat (ITT)||units on a scale||Standard Deviation|Mean
803871|NCT00986258|Secondary|Average Pain Intensity Before the Start of Tapentadol Treatment|"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Baseline|Intention to Treat||units on a scale||Standard Deviation|Mean
803872|NCT00986258|Primary|Number of Participants That Responded to Treatment|Participants were considered responders if they reported the same or less average pain intensity over a 3 day period (NRS-3) after 6 weeks of tapentadol prolonged release treatment as with their previous analgesic treatment (over a 3 day period on the Numeric Rating Scale) at Week 6 compared with Week-1.|6 weeks|Per Protocol Set. Last Observation Carried Forward (LOCF).||participants|||Number
803875|NCT00986349|Primary|Change in Anti-diabetes Medications|Medications were classified as “increased” if the dose of one or more oral agents was higher or an additional glucose-lowering agent was utilized at the time of treatment completion after EndoBarrier implantation in comparison with baseline. Medications were classified as “decreased” if the dose of one or more oral agents was lowered or one or more agents were discontinued at the time of treatment completion in comparison with baseline. For subjects in which the dose of one oral glucose-lowering agent was increased and another agent decreased, the change in medications was classified as “not assessable.”|Baseline to 52 weeks|||Participants|||Count of Participants
803876|NCT00986349|Primary|Assessment of Glycemic Control (HbA1c) Over Time|HbA1c (%) at Baseline, Month 3, Month 6, Month 9, and Month 12|Baseline to 12 Months with device implanted|20 subjects with a successfully implanted device were analyzed at Baseline. 1 subject removed at day 75 due to non-compliance with attending required visits. 1 subject removed at 175 due to device rotation, 2 subjects removed at day 203 and 313 due to abdominal pain AE||HbA1c %||Full Range|Median
803877|NCT00986362|Primary|Percentage of Eyes With Total Macular Posterior Vitreous Detachment (PVD).|Percentage of eyes with total macular PVD (to the vascular ridge in eyes with ROP) at the beginning of vitrectomy or after application of suction, as assessed by masked surgeon observation under the operating microscope.|Beginning of vitrectomy or after application of suction|Study eyes were analysed according to the Intent-to-Treat (ITT) principle, i.e. as randomised regardless of treatment received. The primary endpoint was evaluated using the Full Analysis Set (FAS), with missing data imputed using the Last Observation Carried Forward (LOCF) method. 1 subject contributed 1 eye to both treatment groups||percentage of eyes|Participants||Number
803878|NCT00986401|Secondary|Maximum Plasma Level (Cmax) of Trospium Chloride (Sanctura XR®) Following Oral Administration of Sanctura XR®|Maximum Plasma Level (Cmax) of Trospium Chloride (Sanctura XR®) Following Oral Administration of Sanctura XR® alone and in combination with Glucophage®. Plasma is the fluid portion of the blood in which the cells are suspended.|34 Days|Intent-to-treat, which includes all patients who started the study (randomized). One patient was not included in the analysis due to early discontinuation.||Nanograms per milliliter (ng/mL)||Standard Deviation|Mean
803879|NCT00986401|Primary|Maximum Plasma Level (Cmax) of Metformin Hydrochloride (Glucophage®) Following Oral Administration of Glucophage®|Maximum Plasma Level (Cmax) of Metformin Hydrochloride (Glucophage®) following oral administration of Glucophage® alone and in combination with SanturaXR®. Plasma is the fluid portion of the blood.|34 Days|Intent-to-treat, which includes all patients who started the study (randomized). One patient was not included in the analysis due to early discontinuation.||Nanograms per milliliter (ng/mL)||Standard Deviation|Mean
803880|NCT00986427|Secondary|Number of Subjects Achieving Improvement in the Physician's Global Improvement Assessment (PGIA)|Number of subjects achieving improvement in the PGIA. The investigator assessed the two target fingernails with a rating of Excellent, Good, Fair, No Improvement or Worse based on the comparison between the nails at the current visit and high-resolution photographs of the nails taken at baseline. An improvement was a score of Excellent/Good/Fair vs. No Improvement/Worse.|Week 24|||participants|||Number
803881|NCT00986427|Secondary|Growth of the Treated and Untreated Nail in the Previous 4 Weeks|Growth of the treated and untreated nail the previous 4 weeks. Nail growth was measured in millimeters.|Week 24|||Millimeters (mm)||Standard Deviation|Mean
803882|NCT00986427|Secondary|Change From Baseline in Quality of Life (QOL) Related to Nail Disease|"Change from baseline in quality of life as measured at week 24 by the subject satisfaction Questionnaire question: Overall, how satisfied are you with your nails? Responses ranged from 1 (very satisfied) to 5 (very unsatisfied). A negative number changed from baseline (decrease in grade score) indicates improvement and a positive change (increase in grade score) indicates worsening."|Baseline, week 24|||scores on a scale||Standard Deviation|Mean
803883|NCT00986427|Primary|Change From Baseline in the Physician's Global Assessment (PGA) of Target Fingernails #1 and #2|"Change from baseline in the Physician's Global Assessment (PGA) of target fingernails #1 and #2 as measured at week 24.
The PGA is a static evaluation/measure of the severity of brittle nails signs in target fingernails #1 and #2 (the 2 nails with the most severe signs of brittleness). Evaluated sings were the degree of lamellar onychoschizia, ridging, longtitudinal splitting, fragility/breakage and thickness. The PGA was scored on a 6 point scale from 0 to 5, in which 0 = none, 1 = mild, 2 = mild to moderate, 3 = moderate, 4 = moderate to severe, 5 = severe. A negative number change from baseline (decrease in grade score) indicates improvement and a positive change (increase in grade score) indicates worsening."|Baseline, week 24|||scores on a scale||Standard Deviation|Mean
803884|NCT00986453|Secondary|Dissection Performance|Amount of tissue (g) removed over time (min)|Intraoperative|Two subjects were removed from the analysis of secondary variables owing to protocol deviations.||g/min|Participants|Standard Deviation|Mean
803885|NCT00986453|Secondary|Amount of Tissue Removed||Intraoperative|Two subjects were removed from the analysis of secondary variables owing to protocol deviations.||g|Participants|Standard Deviation|Mean
803886|NCT00986453|Secondary|Operative Time||Intraoperative|Two subjects were removed from the analysis of secondary variables owing to protocol deviations.||minutes|Participants|Standard Deviation|Mean
803887|NCT00986453|Secondary|Estimated Blood Loss||Intraoperative|Two subjects were removed from the analysis of secondary variables owing to protocol deviations.||mL|Participants|Standard Deviation|Mean
803888|NCT00986453|Primary|Postoperative Pain|"The difference in pain was measured by visual analog scale for 24 hours post-operatively and for 10 post-operative days twice daily between the SOC and PlasmaBlade operative sites.
Wong-Baker FACES Visual Analog Scale, 0 (no hurt) to 10 (hurts worst). The results represent the mean of each subject's mean pain scores over 10 days."|0 to 10 days postoperative|Two subjects were removed from the analysis of secondary variables owing to protocol deviations.||units on a scale|Participants|Standard Deviation|Mean
803889|NCT00986479|Secondary|Brief Psychiatric Rating Scale (BPRS) Positive Score.|Brief Psychiatric Rating Scale (BPRS) Positive is a 4-item scale which measures positive symptoms of schizophrenia (conceptual disorganization, hallucinatory behavior, suspiciousness, and unusual thought content). Each item is rated from 1 to 7 with higher score indicating greater severity. The total score is the sum of the 4 items, resulting in a range of scores from 4-28.|60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.|||Units on a scale||Standard Error|Least Squares Mean
812472|NCT01070784|Primary|Clinical Laboratory Test: Haematology -Leucocytes|Change from baseline|Baseline and 52 week after|||/microliter(mcl)||Standard Deviation|Mean
803890|NCT00986479|Secondary|Visual Analogue Scale (VAS) Anxious Score.|"The Visual Analog Scale (VAS) Anxious is a 0 to 100-mm self-administered scale where patients rate their mood between “extreme sad” (0-mm) and “extreme happy (100-mm), with a median “normal” point."|60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.|ITT population including all randomized patients who were given study treatment.||Units on a scale||Standard Error|Least Squares Mean
803891|NCT00986479|Secondary|Young Mania Rating Scale (YMRS) Score.|Young Mania Rating Scale (YMRS) consists of 11 items, rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe) or from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60. 0 is considered to be the best outcome, 60 the worst.|60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.|ITT population including all randomized patients who were given study treatment.||Units on a scale||Standard Error|Least Squares Mean
803892|NCT00986479|Secondary|Beck Depression Inventory (BDI) Score.|Beck Depression Inventory (BDI) is a 21-question instrument for measuring the severity of depression. Each question has a set of at least four possible answer choices, ranging in intensity. A value of 0 to 3 is assigned for each answer and the total score is computed. Higher total scores indicate more severe depressive symptoms.|60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.|ITT population including all randomized patients who were given study treatment.||Units on a scale||Standard Error|Least Squares Mean
803893|NCT00986479|Secondary|Brief Psychiatric Rating Scale (BPRS) Score.|"The Brief Psychiatric Rating Scale (BPRS) is a 18-item scale which measures symptoms and behaviors that are characteristic of schizophrenia. Each item is rated from 1 to 7 with higher score indicating greater severity. The total score is the sum of the 18 items, resulting in a range of scores from 18-126.
18 is considered to be the best outcome, 126 the worst."|60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.|ITT population including all randomized patients who were given study treatment.||Units on a scale||Standard Error|Least Squares Mean
803894|NCT00986479|Secondary|Clinician-Administered Dissociative States Scale (CADSS) Score.|Clinician- Administered Dissociative States Scale (CADSS) is a clinician-administered measure of perceptual, behavioral, and attentional alterations occurring during dissociative experiences. This scale involves a 23 questions and each is rated from 0 (not at all) to 4 (extremely). The total score is sum of the 23 items and range from 0 to 92 - best is 0 and worst is 92.|60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing|ITT population including all randomized patients who were given study treatment.||Units on a scale||Standard Error|Least Squares Mean
803895|NCT00986479|Secondary|Visual Analogue Scale (VAS) Depressed Score|"The Visual Analog Scale (VAS) Depressed is a 0 to 100-mm self-administered scale where patients rate their mood between “extreme sad” (0-mm) and “extreme happy (100-mm), with a median “normal” point."|60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing|ITT population including all randomized patients who were given study treatment.||Scores on a scale||Standard Error|Least Squares Mean
803896|NCT00986479|Secondary|Hamilton Depression Rating Scale-17 Item (HDRS) Total Score|Hamilton Depression Rating Scale-17 item (HDRS) is a scale that assesses depressive symptoms. HDRS consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher scores indicate more severe depression.|60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing|ITT population including all randomized patients who were given study treatment.||Units on a scale||Standard Error|Least Squares Mean
803897|NCT00986479|Secondary|Hamilton Anxiety Rating Scale (HAM-A) Total Score.|Hamilton Anxiety Rating Scale (HAM-A) is used as a rating measure of anxiety severity. The scale consists of 14 items. Each item is rated on a scale of 0 to 4. The HAM-A total score is the sum of the 14 items and the score ranges from 0 to 56. 0 is considered the best outcome, 56 the worst.|60 minutes (min) prior to dosing (baseline); and 230 min, 1 day, 2 days, 3 days and 7 days following dosing.|||Units on a scale||Standard Error|Least Squares Mean
803898|NCT00986479|Secondary|Scale for Suicide Ideation (SSI) Total Score.|Scale for Suicide Ideation (SSI) is a 19-item scale designed to quantify the intensity of current conscious suicide ideation. Each item is rated on a scale of 0 to 2 (with higher scores indicating greater suicidal ideation). The individual item scores are added together to form a total score, ranging between 0 and 38. 0 is considered the best outcome, 38 the worst.|60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.|ITT population including all randomized patients who were given study treatment.||Units on a scale||Standard Error|Least Squares Mean
803899|NCT00986479|Secondary|The Number of Participants With at Least 50% Reduction in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (MADRS Response).|Response defined as a >= 50% reduction from baseline in MADRS total score. MADRS is a 10-item instrument used for the evaluation of depressive symptoms. Each item is rated on a scale of 0 to 6 (with higher scores indicating more severe depression). The individual item scores are added together to form a total score, ranging between 0 and 60. 0 is considered the best score, 60 the worst.|60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.|ITT population including all randomized patients who were given study treatment.||Participants|||Number
803900|NCT00986479|Secondary|The Number of Participants With Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than 10 (MADRS Remission).|Remission defined as a Montgomery-Asberg Depression Rating Scale (MADRS) total score <10. MADRS is a 10-item instrument used for the evaluation of depressive symptoms. Each item is rated on a scale of 0 to 6 (with higher scores indicating more severe depression). The individual item scores are added together to form a total score, ranging between 0 and 60. 0 is considered the best score, 60 the worst.|60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.|ITT population including all randomized patients who were given study treatment.||Participants|||Number
808347|NCT01033448|Primary|Sustained Viral Response (SVR) Rates in CHC Genotype 1|Sustained Viral Response, undetectable HCV-RNA 24 weeks after the end of treatment for genotype 1.|Week 96|Participants with CHC genotype 1 at Week 96||Percentage of participants||95% Confidence Interval|Number
803901|NCT00986479|Primary|Montgomery-Asberg Depression Rating Scale (MADRS) Total Score.|Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item instrument used for the evaluation of depressive symptoms. Each item is rated on a scale of 0 to 6 (with higher scores indicating more severe depression). The individual item scores are added together to form a total score, ranging between 0 and 60. 0 is considered the best score, 60 the worst.|60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.|ITT population including all randomized patients who were given study treatment.||Units on a scale||Standard Error|Least Squares Mean
803902|NCT00986544|Secondary|Number of Participants With Postoperative Complications||1 month|Intention to treat analysis||participants|||Number
803903|NCT00986544|Primary|Number of Participants With Subhepatic Collection at Ultrasonographic Examination|An abdominal ultrasonography was routinely performed on the first postoperative day with the aim to detect any fluid collection. If present, the volume in ml of subhepatic collection was calculated.|first postoperative day|An intention to treat (ITT) analysis was performed.||Participants|||Number
803904|NCT00986570|Primary|Treatment Success|Success has been defined as the reduction of any grade to a lower grade of expression wrinkles in the visit 3 (day 15) compared to the baseline assessment. The wrinkles will be classified according to the following: absence, mild, moderate, severe.|Baseline (pre-treatment) and Visit 3 (Day 15)|||% of participants||95% Confidence Interval|Number
803905|NCT00986583|Secondary|Fasciculation|The fasciculation ranges from 0 to 3: 0 none; 1 small movements around eyes and fingers; 2 moderate movements in face, neck, fingers, and trunk; and 3 vigorous movements in trunk and extremities.|postoperative|||participants|||Number
803906|NCT00986583|Secondary|Duration of Succinylcholine Block|Time required to reach maximum block by succinylcholine after succinylcholine administration.|intraoperative: from succinylcholine administration|||minute||Inter-Quartile Range|Median
803907|NCT00986583|Secondary|Change in Plasma Creatine Phosphokinase (CK) Concentration From 2 to 24 Hours Postoperatively|Change in plasma creatine phosphokinase (CK) concentration from 2 to 24 hours postoperatively|2 and 24 hours postoperatively|Two patients in the nonstatin group had missing CK value at 2 hour||units/l||Inter-Quartile Range|Median
803908|NCT00986583|Secondary|Serum Potassium Concentration||At 5 and 20 min after succinylcholine|Two patients in non-statin group had missing value at 20 minute.||mEq/l||Inter-Quartile Range|Median
803909|NCT00986583|Secondary|Muscle Pain|"verbal rating scale score and the pain score both at 2 and 24 hours postoperatively.
The verbal rating scale score ranges from 0 (no pain) to 100 (worst pain imaginable).
The pain score ranges from 0 to 3: 0 none; 1 muscle stiffness or pain in the nape of the neck, shoulders, and chest; 2 muscle stiffness and pain requiring analgesia; and 3 incapacitating generalized muscle stiffness or pain."|2 and 24 hours postoperatively|||participants|||Number
803910|NCT00986583|Primary|Plasma Myoglobin Concentration||induction, 5 minutes after administration, 20 minutes and 24 hours post operatively|||ug/l||Inter-Quartile Range|Median
803911|NCT00986674|Secondary|Response Rate|Tumor response was assessed via Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. Complete response (CR) was defined disappearance of all tumor lesions. Partial response (PR) was defined as as at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter. Overall response rate= CR+PR.|Tumor measurements are repeated every 6 weeks while on treatment. After off treatment, assessed every 3 months if patient is < 2 years from study entry and every 6 months in year 3|eligible and treated patients who have response data. 3 patients on arm I and 1 patient on arm III had unknown/missing tumor response and were excluded from the analysis||percentage of participants||95% Confidence Interval|Number
803912|NCT00986674|Secondary|Overall Survival|Overall survival is defined as time from registration to death from any cause.|assessed every 3 months if patient is < 2 years from study entry and every 6 months in year 3|eligible and treated patients||months||95% Confidence Interval|Median
803913|NCT00986674|Primary|Progression Free Survival|"Progression free survival is defined as time from registration to disease progression or death from any cause, whichever occurred earlier. Disease progression was assessed via Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, and/or the appearance of one or more new lesion(s), and/or unequivocal progression of existing nontarget lesions .
All eligible and treated patients were included in the analysis."|Tumor measurements are repeated every 6 weeks while on treatment. After off treatment, assessed every 3 months if patient is < 2 years from study entry and every 6 months in year 3|eligible and treated patients||months||95% Confidence Interval|Median
803914|NCT00986856|Secondary|The Actual Change in Total Severity Score From Baseline to End of Treatment (LOCF).|Total Severity Score is the sum of scores for the following 5 signs: Pustules/infected bullae, erythema, infiltration/induration, erosions and crusting. Each sign is assessed using a 4-point scale: 0=absent, 1=mild, 2=moderate and 3=severe involvement. Minimum Total Severity score is 0, maximum score is 15.|EOT: Visit at day 25|The full analysis set consists of 56 patients, 40 patients in the Fucidin® cream 20 mg/g group and 16 patients in the Fucidin® cream vehicle group (2 patients excluded because of lack of efficacy data)||Units on a scale||Standard Error|Mean
803915|NCT00986856|Secondary|Number of Patients With Bacteriological Success at EOT||EOT: Visit at day 25|The analysis population was the full (intention-to treat) analysis set including the patients with confirmed presence of pathogenic bacteria (S. aureus and/or betahaemolytic streptococci (group A)) at baseline||Participants|||Number
803916|NCT00986856|Secondary|Number of Patients With Bacteriological Success at Visit 3||Visit 3: Day 11|The analysis population were those patients who had a visit 3 observation||Participants|||Number
803917|NCT00986856|Secondary|Number of Patients With Bacteriological Success at Visit 2||Visit 2: Day 4|The analysis population was the full (intention-to treat) analysis set including the patients with confirmed presence of pathogenic bacteria (S. aureus and/or betahaemolytic streptococci (group A)) at baseline||Participants|||Number
803918|NCT00986856|Secondary|Number of Patients With Clinical Success at EOT||EOT: Visit at day 25|The full analysis set consists of 56 patients, 40 patients in the Fucidin® cream 20 mg/g group and 16 patients in the Fucidin® cream vehicle group (2 patients excluded because of lack of efficacy data)||Participants|||Number
803919|NCT00986856|Secondary|Number of Patients With Clinical Success at Visit 3||Visit 3: Day 11|The analysis population were those patients who had a visit 3 observation||Participants|||Number
803921|NCT00986856|Primary|Number of Patients With Clinical Success (Marked Improvement or Completely Cleared) and Bacteriological Success (Eradication) at End of Treatment (EOT).||EOT: Visit at Day 25|The analysis population was the full (intention-to treat) analysis set including the patients with confirmed presence of pathogenic bacteria (S. aureus and/or betahaemolytic streptococci (group A)) at baseline||Participants|||Number
803922|NCT00986921|Secondary|Moderate or Severe Pain Overnight|Women wer asked to rank their amount of pain on a catergorical scale. The outcome measure is the number of women experiencing moderate or severe pain overnight (after mifepristone or osmotic dilators, and before the abortions procedure)|Overnight|All participants are included||percentage of participants|||Number
803923|NCT00986921|Secondary|Assessment of Ease of Procedure by Operator|"The operator for each procedure rated the ease of procedure on a categorical scale. The categories were collapsed into two: easy or very easy and average or difficult."|It is administered shortly after the primary outcome, which is one day after enrollment. The study is complete at that point.|"All participants with a completed abortion procedure were rated by the operator as to ease of completing the procedure. The number of women in each group having an abortion procedure rated easy or very easy is tabulated"||percentage of participants|||Number
803924|NCT00986921|Primary|Time for Completion of Procedure|Minutes, from the time of the start of the procedure (speculum insertion) to the conclusion of the procedure (speculum removal)|Performance and completion of the abortion procedure takes 10-20 minutes. The length of the procedure is measured. The procedure occurs approximately 24 hours after enrollment.|Of the 25 women enrolled in the osmotic dilator group, all had osmotic dilators insertion. One woman aborted spontaneously before the surgical abortion; therefore she did not have an abortion procedure and time could not be obtained. she did contribute information about her experience to that point.||Minutes||95% Confidence Interval|Mean
803925|NCT00986947|Secondary|Decrease in Panel Reactive Antibody||4 months|Data was not collected for this outcome measure. The study was terminated prematurely due to the P.I. leaving the institution.|||||
803926|NCT00986947|Primary|Time to Kidney Transplantation||4 months|Data was not collected for this outcome measure. The study was terminated prematurely due to the P.I. leaving the institution.|||||
803927|NCT00986960|Secondary|To Define the Effect of add-on Pulsed IM ACTH vs. Placebo to IFNβ-1a I.M. in RRMS on Anterior Optic Pathway Pathology, as Measured by OCT and LCLA in Patients With RRMS.||1 year||||||
803928|NCT00986960|Primary|To Define the Effect of add-on Pulsed IM ACTH vs. Placebo to IFNβ-1a I.M. on a Voxel-wise MTR Dynamic Mapping of the Lesions and NABT in Patients With RRMS|None. Study did not initiate recruitment or data collection.|1 year||||||
803929|NCT00986973|Secondary|Delis-Kaplan Executive Function System Verbal Fluency Subtest (D-KEFS)|The Delis–Kaplan Executive Function System (D-KEFS) is a neuropsychological test is used to measure a variety of verbal and nonverbal executive functions for both children and adults. Among the 9 subtests is the Verbal Fluency Test which measures letter fluency, category fluency, and category switching. Verbal Fluency Test. This subtest requires an individual to randomly generate words based upon given parameters (ex., as words beginning with the letter F) and the believed areas of executive function assessed are cognitive flexibility, response inhibition, and verbal fluency. Raw scores are calculated based on the number of correct answers, which are then converted to scaled scores with a mean of 10 and standard deviation of 3. Higher scaled score represents a higher level of executive verbal and nonverbal function.|Measures were obtained at the beginning and conclusion of each study period (baseline and 4 months)|1 Subject was withdrawn from the study due to poor compliance with KUVAN therapy and did not complete all assessments.||units on a scale||Inter-Quartile Range|Median
803930|NCT00986973|Secondary|Wechsler Adult Intelligence Scale (WAIS-IV)-Digit Span|The Wechsler Adult Intelligence Scale (WAIS) is a test designed to measure intelligence in adults and older adolescents. It is composed of 10 core subtests and five supplemental subtests, with the 10 core subtests comprising the Full Scale intelligence quotient (IQ). Contained within the WAIS is an assessment of digit-coding which consists of nine digit-symbol pairs followed by a list of digits. Under each digit the subject should write down the corresponding symbol as fast as possible. The number of correct symbols within the allowed time (e.g. 90 or 120 sec) is measured, with a higher score representative of a higher performance component of IQ/intelligence.|Measures were obtained at the beginning and conclusion of each study period (baseline and 4 months)|1 Subject was withdrawn from the study due to poor compliance with KUVAN therapy and did not complete all WAIS-IV assessments.||Number of correct symbols||Inter-Quartile Range|Median
803931|NCT00986973|Secondary|Symbol-Digit Modalities Test (SMTD)|The symbol-digit modalities test (SDMT) was developed to identify individuals with neurological impairment. The SDMT requires individuals to identify nine different symbols corresponding to the numbers 1 through 9, and to practice writing the correct number under the corresponding symbol. Then they manually fill the blank space under each symbol with the corresponding number. A second oral administration is then completed. The participant is given a blank copy of the test and asked to state the correct number for each corresponding symbol. The participant is given 90 s to complete each of these administrations. A written and oral score is calculated by totaling the number of correct answers for each section. The score is the number of correctly coded items from 0-110 in 90 seconds, with a higher score representing less neurological impairment with respect to attention, scanning abilities and motor skills. The total raw score was used for purposes of this study.|Measures were obtained at the beginning and conclusion of each study period (baseline and 4 months)|1 Subject was withdrawn from the study due to poor compliance with KUVAN therapy and did not complete all SMTD assessments.||units on a scale||Inter-Quartile Range|Median
803948|NCT00987337|Secondary|Number of Participants With Dose Reduction or Temporary Discontinuation Due to Adverse Events (AEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to Week 72|Safety population included all randomized participants who took at least 1 dose of study drug analyzed as treated.||participants|||Number
804096|NCT00994279|Secondary|Fatigue at 10 Weeks|FACIT-Fatigue patient reported outcome. This questionnaire consists of 13 questions answered on a 0 to 4 scale with a min of 0 and a max of 52. Higher scores indicate less fatigue.|10 weeks|Participants with 10 week outcome data. Note that one participant in the Wellness group was missing this outcome even though they completed the study.||units on a scale||Standard Error|Least Squares Mean
803932|NCT00986973|Secondary|Paced Auditory Serial Addition Task (PASAT)|The Adapted Paced Auditory Serial Addition Task (PASAT) is a measure of cognitive function that specifically assesses auditory information processing speed and flexibility, as well as calculation ability. For Rates #1 and #2, single digits are presented every 3 seconds and the patient must add each new digit to the one immediately prior to it. The score for PASAT is the total number of correct answers (out of 60, for a total possible score ranging from 0-60 with higher score preferred as it indicates higher auditory processing speed) for each trial. All scores are expressed as “z-scores” which are generated based on norms for 101 healthy adults, with separate norms for <12 years of education versus >12years of education. Using a reference population as a basis of comparison, the “z-score” is the number of standard deviations the score is above (positive) or below (negative) the mean of the reference population (zero). Possible z-scores lie on a continuous scale.|Measures were obtained at the beginning and conclusion of each study period (baseline and 4 months)|1 Subject was withdrawn from the study due to poor compliance with KUVAN therapy and did not complete all PASATassessments.||units on a scale||Inter-Quartile Range|Median
803933|NCT00986973|Secondary|Hopkins Verbal Learning Test (HVLT) Delayed Recall|The Hopkins Verbal Learning Test-Revised (HVLT) is a neuropsychological test designed to assess verbal memory. The test consists of 12 nouns (targets) with four words drawn from each of three semantic categories. Raw scores are derived for Total Recall (across three learning trials), Delayed Recall (after 20-25 minute delay), Retention (% retained), and a Recognition Discrimination Index (true positives minus false positives). The maximum total for each recall trial (Learning Trials 1 to 3, Delayed Recall Trial 4) is 12. Raw scores are converted to “T-scores” by means of age-based tables provided in test manual (T-scores can go from 0 – 100, with higher scores correlating with higher verbal memory function). Median HVLT Total Recall and HVLT Delayed Recall T-scores at baseline and 4 months after Sapropterin therapy were compared.|Measures were obtained at the beginning and conclusion of each study period (baseline and 4 months)|1 Subject was withdrawn from the study due to poor compliance with KUVAN therapy and did not complete all HVLT assessments.||units on a scale||Inter-Quartile Range|Median
803934|NCT00986973|Secondary|Hopkins Verbal Learning Test (HVLT) Total Recall|The Hopkins Verbal Learning Test-Revised (HVLT) is a neuropsychological test designed to assess verbal memory. The test consists of 12 nouns (targets) with four words drawn from each of three semantic categories. Raw scores are derived for Total Recall (across three learning trials), Delayed Recall (after 20-25 minute delay), Retention (% retained), and a Recognition Discrimination Index (true positives minus false positives). The maximum total for each recall trial (Learning Trials 1 to 3, Delayed Recall Trial 4) is 12. Raw scores are converted to “T-scores” by means of age-based tables provided in test manual (T-scores can go from 0 – 100, with higher scores correlating with higher verbal memory function). Median HVLT Total Recall and HVLT Delayed Recall T-scores at baseline and 4 months after Sapropterin therapy were compared.|Measures were obtained at the beginning and conclusion of each study period (baseline and 4 months)|1 Subject was withdrawn from the study due to poor compliance with KUVAN therapy and did not complete all HVLT assessments.||units on a scale||Inter-Quartile Range|Median
803935|NCT00986973|Primary|Plasma Phenylalanine Level (mg/dl)|Plasma phenylalanine level (mg/dl) served as the primary means of evaluating brain glucose metabolism before and after sapropterin (KUVAN) therapy. Blood tests for phenylalanine levels (Phe) were collected before and 4 months after sapropterin (KUVAN) therapy. All subjects received KUVAN at a dose of 20/mg/kg/day for four months. The goal was to estimate the change in blood glucose metabolism after treatment with Sapropterin (if any), with the hypothesis that treatment would decrease plasma Phe levels.|Measurements were obtained at the beginning and conclusion of each study period (baseline and 4 months)|1 subject was withdrawn from the study due to poor compliance with KUVAN therapy.||mg/dl||Standard Deviation|Mean
803936|NCT00986986|Secondary|HDL||12 weeks||||||
803937|NCT00986986|Primary|Flow Mediated Vasodilation|Flow mediated vasodilation is a marker of endothelial function|12 weeks|||percentage change in FMD||Inter-Quartile Range|Median
803938|NCT00986986|Secondary|High-density Lipoprotein Cholesterol (HDL) Change From Baseline to Study Week 12|"HDL, often referred to Good cholesterol levels, will be obtained in both arms. HDL is a marker of coronary heart disease."|Two time points (baseline and study week 12)|||mg/dl||Inter-Quartile Range|Median
803939|NCT00986986|Primary|Change in Flow-mediated Vasodilation (FMD) From Baseline to Study Week 12|Brachial arterial flow-mediated dilation (FMD), assessed by high-resolution ultrasonography, reflects endothelium-dependent vasodilator function. The primary outcome is the change in FMD from baseline to study week 12.|Two time points (baseline and study week 12)|HIV infected patients with HDL-C < 40||percentage change in FMD||Inter-Quartile Range|Median
803940|NCT00986999|Secondary|Change in hsCRP||3 months||||||
803941|NCT00986999|Secondary|Change in Total, HDL and LDL Cholesterol and Triglyceride Levels||3 months||||||
803942|NCT00986999|Secondary|Change in Glucose Homeostasis and Insulin Resistance as Assessed by Oral Glucose Tolerance Testing||3 months||||||
803943|NCT00986999|Secondary|Change in Mitochondrial-specific Oxidative Stress (Mt-specific 8-oxo-dG) and Oxidative Phosphorylation (OXPHOS) Protein/Enzyme Activity [Complex I and Complex IV] Levels||3 months||||||
803944|NCT00986999|Secondary|Change in HIV Biomarkers of Immune Activation to Include CD38 and CD69 Expression on T Cells and CD16 and CD69 Expression on Monocytes||3 months||||||
803945|NCT00986999|Primary|Change in Flow Mediated Dilatation (FMD) of the Brachial Artery||3 months|Not analyzed|||||
803946|NCT00987337|Secondary|Plasma Concentration of Filibuvir, Pegylated Interferon and Ribavirin||Week 0 (pre-dose), Week 2, 4, 8, 12, 16, 20, 24, 48 (only for those participants who received treatment till Week 48) post-dose|Data could not be summarized due to sparse sampling time points adopted for this study.|||||
803947|NCT00987337|Secondary|Number of Participants With Laboratory Test Abnormalities by Severity|Number of participants with laboratory abnormalities by Division of Auto Immune Disease Syndrome (DAIDS) grade of 4; 3 or 4; 2, 3 or 4 was summarized. Abnormal laboratory values refers to a DAIDS grade greater than 0, where grade 1= mild, grade 2= moderate, grade 3= severe and grade 4 = potentially life-threatening.|Baseline up to Week 72|Safety population included all randomized participants who took at least 1 dose of study drug analyzed as treated. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||participants|||Number
804097|NCT00994279|Primary|Retention|Proportion of participants completing the 10 week study|10 weeks|All randomized participants||percentage of participants||95% Confidence Interval|Number
803949|NCT00987337|Secondary|Number of Participants Who Discontinued Study Due to Adverse Events (AEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to Week 72|Safety population included all randomized participants who took at least 1 dose of study drug analyzed as treated.||participants|||Number
803950|NCT00987337|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Relationship to Study Drug (Any Therapy)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Week 72 that were absent before treatment or that worsened relative to pretreatment state. All causality AEs included SAEs as well as non-serious AEs, without regard to relationship to the study drug, which occurred during the trial. Treatment-related were events considered related to study drug by the investigator. Number of participants with treatment related TEAEs and all causality TEAEs were summarized.|Baseline up to Week 72|Safety population included all randomized participants who took at least 1 dose of study drug analyzed as treated.||participants|||Number
803951|NCT00987337|Secondary|Number of Adverse Events (AEs) by Severity (All Causality)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Adverse events were graded as mild (did not interfere with participant's usual function), moderate (interfered to some extent with participant's usual function) or severe (interfered significantly with participant's usual function). The most severe grade was used in case of multiple occurrences of the same event.|Baseline up to Week 72|Safety population included all randomized participants who took at least 1 dose of study drug analyzed as treated.||adverse events|||Number
803952|NCT00987337|Secondary|Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4, 12 and 24|Plasma HCV RNA levels were measured using the Roche COBAS TaqMan assay (limit of detection: 15 IU/mL). Baseline value calculated as the average of the screening and Day 1 pre-dose measurements.|Baseline, Week 4, 12, 24|ITT population included all randomized participants who took at least 1 dose of study drug. LOCF method was used for imputing missing values for participants who did not discontinue from study. Final value was imputed as baseline for participants who discontinued before the time point of interest.||log10 IU/mL||Standard Deviation|Mean
803953|NCT00987337|Secondary|Percentage of Participants With Relapsed Response|A participant was considered to have relapsed response if the plasma HCV RNA levels were undetectable at end of treatment (Week 24 or 48, depending on the time of therapy discontinuation based on HCV RNA levels during therapy) but detectable (>=15 IU/mL) during the off-treatment follow-up period up to Week 72. Overall percentage of participants with relapsed response was summarized.|Week 24 or Week 48 up to Week 72|ITT population included all randomized participants who took at least 1 dose of study drug. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. Participant with all the HCV RNA values missing during follow-up was imputed as having relapsed.||percentage of participants|||Number
803954|NCT00987337|Secondary|Percentage of Participants With Breakthrough Viremia|A participant was considered to have breakthrough viremia if there was a >2 log10 increase from nadir in HCV RNA concentration while on treatment or HCV RNA that became undetectable with treatment but then became persistently detectable (2 or more consecutive viral RNA measurements >1000 IU/mL) again during treatment. Overall percentage of participants with breakthrough viremia was summarized.|Baseline up to Week 48|ITT population included all randomized participants who took at least 1 dose of study drug.||percentage of participants|||Number
803955|NCT00987337|Secondary|Percentage of Participants With Sustained Viral Response at 24 Weeks Following Completion of Therapy (SVR24)|SVR24 was summarized only for those participants who received filibuvir, had undetectable HCV RNA from Week 4 through 24 and discontinued therapy at Week 24 and all participants who received placebo for 48 weeks. A participant was considered to have achieved SVR24 if the plasma HCV RNA levels were <15 IU/mL at both the end of treatment (Week 24 for filibuvir participants who ended therapy at Week 24 and Week 48 for participants who received placebo) and 24 weeks following the completion of therapy (Week 48 for filibuvir participants who ended therapy at Week 24; Week 72 for placebo participants who ended therapy at Week 48).|24 weeks after completion of therapy (Week 48 or 72)|ITT population.N (number of participants analyzed)=evaluable participants for the measure. Missing HCV RNA value at EOT, all follow-up visits/at specified time point, all subsequent visits was considered not to have undetectable HCV RNA.Missing HCV RNA value at 24 weeks after EOT was imputed using value of subsequent follow-up visit, if available.||percentage of participants|||Number
803956|NCT00987337|Secondary|Percentage of Participants With Sustained Viral Response at 12 Weeks Following Completion of Therapy (SVR12)|A participant was considered to have achieved SVR12 if the plasma HCV RNA levels were <15 IU/mL at both the end of treatment (Week 24 or 48, depending on the time of therapy discontinuation based on HCV RNA levels during therapy) and 12 weeks following the completion of therapy (Week 36 for participants who ended therapy at Week 24; Week 60 for participants who ended therapy at Week 48). Overall percentage of participants with SVR12 was summarized.|12 weeks after completion of therapy (Week 36 or 60)|ITT population. Participant with missing HCV RNA values at end of treatment and all follow-up visits or at the specified time point and all subsequent visits was considered not to have undetectable HCV RNA. Missing HCV RNA value at 12 weeks following completion of therapy was imputed using value of subsequent follow-up visit, if available.||percentage of participants|||Number
804005|NCT00988091|Primary|Change From Baseline in the Visual Analogue Score (VAS) Pain Score of the 50-foot Walk Test at Week 26|The level of pain is estimated by the participant following a walk of 50 feet in length which is observed by the investigator. Pain estimates were recorded on a 100 millimeter visual analog scale. A score of 0 millimeters means there was no pain; a score of 100 millimeters means extreme pain. Change from baseline is calculated: week 26 VAS Pain Score - Baseline VAS Pain Score.|Day 0 (baseline) through Week 26|Intent to treat population||units on a scale||Standard Error|Least Squares Mean
803957|NCT00987337|Secondary|Percentage of Participants With Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4, 12, 24 and 48|Percentage of participants with undetectable HCV RNA at Week 4 (rapid viral response [RVR]), Week 12 (early viral response [EVR]), Week 24 and Week 48 were summarized. Undetectable HCV RNA was defined as plasma HCV RNA levels <15 IU/mL.|Week 4, 12, 24, 48|ITT population included all randomized participants who took at least 1 dose of study drug. Last observation carried forward (LOCF) method was used to impute missing values for participants who did not discontinue from study. Participants who discontinued early from the study were considered not to have undetectable HCV RNA.||percentage of participants|||Number
803958|NCT00987337|Primary|Percentage of Participants With Sustained Viral Response (SVR) at Week 72|For participants who received filibuvir, had undetectable HCV RNA from Week 4 through 24 and discontinued therapy at Week 24, SVR was defined as undetectable plasma HCV RNA levels (<15 IU/mL) at both Week 24 (End of Treatment [EOT]) and Week 72, regardless of the HCV RNA levels between Week 24 and 72. For participants who received filibuvir, had detectable HCV RNA at Week 4 or later and discontinued therapy at Week 48 or who received placebo, SVR was defined as undetectable plasma HCV RNA levels (<15 IU/mL) at both Week 48 (EOT) and Week 72, regardless of the HCV RNA levels between Week 48 and 72.|Week 72|ITT population included all randomized participants who took at least 1 dose of study drug. If a participant had a missing value at Week 72, participant was considered a failure; if a participant had achieved SVR but died or discontinued within same time period, the participant was considered a success.||percentage of participants|||Number
803959|NCT00987402|Primary|Surgical Site Infection|255 (8.1%) patients developed SSIs. Rates for the two study arms were similar (8.3% for alcohol-based handrub versus 8.0% for plain soap and water; odds ratio, 1.03; 95% CI, 0.80 - 1.33).|30 days post-operatively|||Participants|||Number
803960|NCT00987402|Secondary|Cost of Hand Preparation Agent|Average weekly costs were estimated for the plain soap and water used each week in the operating room as well as for the procurement, preparation and dispensing of the alcohol-based handrub to enable a comparison between the two study arms.|30 days||||||
803961|NCT00987415|Secondary|Change in Submaximal Exercise Capacity (6-MWT)|6-Minute Walk Test|Baseline to 24 weeks|Participants analyzed included those patients who had complete data for this endpoint.||meters||Standard Deviation|Mean
803962|NCT00987415|Secondary|Change in Quality of Life (KCCQ)|Kansas City Cardiomyopathy (KCCQ) overall summary score - The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.|Baseline to 24 weeks|Participants analyzed included those patients who had complete data for this endpoint.||units on a scale||Standard Deviation|Mean
803963|NCT00987415|Secondary|Change in Submaximal Exercise Capacity (6-MWT)|6-Minute Walk Test|Baseline to 12 weeks|Participants analyzed included those patients who had complete data for this endpoint.||meters||Standard Deviation|Mean
803964|NCT00987415|Secondary|Change in Quality of Life (KCCQ).|Kansas City Cardiomyopathy (KCCQ) overall summary score - The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.|Baseline to 12 weeks|Participants analyzed included those patients who had complete data for this endpoint.||units on a scale||Standard Deviation|Mean
803965|NCT00987415|Primary|A Composite Clinical Endpoint (CCE) That Classifies Subject's Clinical Status as Improved, Worsened, or Unchanged.|CCE composed of 3-level categorical variable with options that include worsened, unchanged or improved|24 Weeks|||participants|||Number
803966|NCT00987467|Secondary|Corticosteroid Usage|Number of flare-ups requiring topical steroid-use across all participants over the entire 12 month follow-up period|12 months or longer|||Total number of flare-up episodes|||Number
803967|NCT00987467|Primary|Ocular Symptoms and Signs Total Composite Score|Symptoms (itching, tearing, discomfort, discharge, photophobia) and signs (Bublar conjunctival hyperemia, upper tarsal conjunctival papillae, punctate keratitis, corneal neovascularization, cicatrizing conjunctivitis, and blepharitis) evaluated on a 4 point scale of 0-3, with a minimum symptom score of 0- maximum 15, and sign score minimum 0-maximum 18, and total composite score of signs and symptoms of minimum 0-maximum 33. The highest score would indicate the most severe case of AKC.|Baseline and 8 weeks|||units on a scale||Full Range|Mean
803968|NCT00987558|Primary|Simvastatin AUC0-∞ (AUC From Time Zero to Infinity)|Simvastatin (Reference) ESL + Simvastatin (Test)|Day 1 and Day 14|||ng.h/mL||Standard Deviation|Mean
803969|NCT00987558|Primary|Simvastatin AUC0-t|"AUC0-t - area under the plasma concentration versus time curve (AUC) from time zero to the last sampling time at which concentrations were at or above the limit of quantification
Simvastatin (Reference) ESL + Simvastatin (Test)"|Day 1 and Day 14|||ng.h/mL||Standard Deviation|Mean
803970|NCT00987558|Primary|Simvastatin Tmax (Time of Occurrence of Cmax)|Simvastatin (Reference) ESL + Simvastatin (Test)|Day 1 and Day 14|||hours||Standard Deviation|Mean
803971|NCT00987558|Primary|Simvastatin Cmax (Maximum Plasma Concentration)|Simvastatin (Reference) ESL + Simvastatin (Test)|Day 1 and Day 14|||ng/mL||Standard Deviation|Mean
803972|NCT00987623|Primary|Overall Lens Satisfaction|Overall Lens Satisfaction, as interpreted by the participant and reported on a questionnaire as a single, retrospective evaluation of 1-week’s wear time. Overall lens satisfaction was measured on a 10-point scale, with 1 being Poor and 10 being Excellent|1 week|Analysis conducted per protocol, with exclusions due to major protocol deviations as determined by masked review, discontinuations, and/or missing responses.||Units on a Scale||Standard Deviation|Mean
804006|NCT00988117|Secondary|Pre-post Change in Montreal Cognitive Assessment|The Montreal Cognitive Assessment (MoCA) was used as measure of global cognitive function. Total scores range from 0 (worst) to 30 (best).|Baseline and 12 weeks|||units on a scale||Standard Deviation|Mean
804172|NCT00996892|Secondary|Cmax of Pictilisib on Cycle 1 Day 1 – Stage 1A All Cohorts||Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 15-17|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
803973|NCT00987727|Secondary|Change From Baseline in Ocular Surface Disease Index (OSDI) Questionnaire Score at Day 35|Change from baseline in Ocular Surface Disease Index (OSDI) questionnaire score at Day 35. The OSDI questionnaire consists of 12 questions measuring the presence of ocular symptoms. Each of the 12 questions is assessed using a 5-point scale (where 0=none of the time and 4=all of the time). The score is converted to a 0-100 point score where 0 is no symptoms and 100 is most symptoms.|Baseline, Day 35|Per Protocol: All subjects who were randomised, who received at least one dose of the study product, had at least one follow-up visit and who did not have significant protocol violations and who completed the assessment of this outcome measure at Day 35.||Number on a scale (score)||Standard Deviation|Mean
803974|NCT00987727|Primary|Change From Baseline in Global Ocular Staining Score at Day 35|Change from baseline in global ocular staining score (range from 0-15) at Day 35. The global ocular staining score is the sum of three different staining severities, each with a score of 0-5 on a 6-point scale, where 0 is no staining (best) and 5 is diffuse staining (worst).|Baseline, Day 35|Per Protocol: All subjects who were randomised, who received at least one dose of the study product, had at least one follow-up visit and who did not have significant protocol violations and who completed the assessment of this outcome measure at Day 35.||Number on a scale (score)||Standard Deviation|Mean
803975|NCT00987831|Post-Hoc|Time to Flare Comparing Patients With (at Baseline) British Isles Lupus Assessment Group Index (BILAG) >/= 17 (Severe Disease) to Those With BILAG < 17 (Moderate Disease Activity).||12 months|Only 40/41 entered patients completed the study by the definition of the endpoint which was flare.||days to flare||95% Confidence Interval|Median
803976|NCT00987831|Primary|Time to Flare Comparing Patients With Moderate vs Severe Disease Activity at Baseline|Group A only: patients on immunosuppressive treatments had them withdrawn at baseline. All patients were allowed up to 160 mg depomedrol at baseline which could be repeated within two weeks up to a total of 4 shots maximum or until satisfactory improvement. Time to flare was calculated from baseline. moderate disease at baseline was defined as up to 3 BILAG B (moderate disease) organ scores, no BILAG A (severe disease) score and a SLEDAI </= 10. Severe disease required >3 BILAG B, OR at least one BILAG A OR SLEDAI > 10 or meeting criteria for a severe flare on the SELENA SLEDAI flare index. At baseline 25 patients with moderate disease. 16 patients had severe disease. Note: severe rash with A on BILAG is only SLEDAI=2, explaining some discrepancies in measures|12 months|This prespecified primary outcome was restricted to Group A only. This was an exploratory proof of concept study, not powered for the primary endpoint||days to flare||95% Confidence Interval|Median
803977|NCT00987935|Secondary|fe0-12,ss (Fraction Excreted in Urine Between 0 and 12 Hours at Steady State) for Nintedanib|"fe0-12,ss (fraction excreted in urine between 0 and 12 hours at steady state) for Nintedanib.
The reported value corresponds to the percentage of administered dose."|0 to 4 hours (h), 4 to 12 h, and 12 to 24 h after nintedanib|Pharmacokinetic set (PKS): The PK set was a subset of the treated set and included all patients who received at least one dose of trial medication and for whom at least one PK observation was available.||percentage||Geometric Coefficient of Variation|Geometric Mean
803978|NCT00987935|Secondary|Cmax,ss,Norm (Maximum Concentration of the BIBF 1202 Glucuronide in Plasma at Steady State, Normalised Values)|"Cmax,ss,norm (maximum concentration of the BIBF 1202 glucuronide in plasma at steady state, normalised values).
Detailed time points of sampling are:
Phase I and selected phase II patients in the Nintedanib arm:
Cycle 1, Day 15 to 16: Immediately prior to swallowing the dose of nintedanib (predose) and 1 hour (h), 2 h, 3 h, 4 h, 5 h, 7 h, 10 h, 12 h and 24 h after drug administration on Day 15; Cycle 2, Day 1: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 1; Cycle 2, Day 15: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 15."|Day1, Day15 and Day 16|Pharmacokinetic set (PKS): The PK set was a subset of the treated set and included all patients who received at least one dose of trial medication and for whom at least one PK observation was available.||(ng/mL)/mg||Geometric Coefficient of Variation|Geometric Mean
803979|NCT00987935|Secondary|Cmax,ss,Norm (Maximum Concentration of the BIBF 1202 in Plasma at Steady State, Normalised Values)|"Cmax,ss,norm (maximum concentration of the BIBF 1202 in plasma at steady state, normalised values).
Detailed time points of sampling are:
Phase I and selected phase II patients in the Nintedanib arm:
Cycle 1, Day 15 to 16: Immediately prior to swallowing the dose of nintedanib (predose) and 1 hour (h), 2 h, 3 h, 4 h, 5 h, 7 h, 10 h, 12 h and 24 h after drug administration on Day 15; Cycle 2, Day 1: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 1; Cycle 2, Day 15: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 15."|Day1, Day15 and Day 16|Pharmacokinetic set (PKS): The PK set was a subset of the treated set and included all patients who received at least one dose of trial medication and for whom at least one PK observation was available.||(ng/mL)/mg||Geometric Coefficient of Variation|Geometric Mean
803980|NCT00987935|Secondary|Cmax,ss,Norm (Maximum Concentration of the Nintedanib in Plasma at Steady State, Normalised Values)|"Cmax,ss,norm (maximum concentration of the Nintedanib in plasma at steady state, normalised values).
Detailed time points of sampling are:
Phase I and selected phase II patients in the Nintedanib arm:
Cycle 1, Day 15 to 16: Immediately prior to swallowing the dose of nintedanib (predose) and 1 hour (h), 2 h, 3 h, 4 h, 5 h, 7 h, 10 h, 12 h and 24 h after drug administration on Day 15; Cycle 2, Day 1: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 1; Cycle 2, Day 15: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 15."|Day1, Day15 and Day 16|Pharmacokinetic set (PKS): The PK set was a subset of the treated set and included all patients who received at least one dose of trial medication and for whom at least one PK observation was available.||(ng/mL)/mg||Geometric Coefficient of Variation|Geometric Mean
803994|NCT00988065|Other Pre-specified|Percentage of Participants With an Adverse Event Suggestive of a Dose-dependent Trend That Also Exceeds a Frequency Threshold Above 5% in Any Treatment Arm (Including Both Serious and Non-serious Adverse Events).|All adverse events from the study were reviewed for potential safety signals. The reported incidences suggestive of a dose-dependent trend and with a frequency threshold above 5% (including both serious and non-serious adverse events) are presented.|From first randomized dose (Day 8) up to 30 days after day of last randomized dose of study medication.|All-Subjects as treated (i.e., who received at least one dose of randomized study medication).||percentage of participants|||Number
808348|NCT01033448|Primary|End of Treatment Response in Genotype 2 and 3|End of treatment response rate at Week 48 was reported for genotype 2 and 3.|Week 48|Participants with CHC Genotype 2 and 3 at Week 48.||Percentage of Participants|||Number
803981|NCT00987935|Secondary|AUC0-12,ss,Norm (Area Under the Plasma Concentration-time Curve Between 0 and 12 Hours at Steady State, Normalised Values) of BIBF 1202 Glucuronide (Metabolite of Nintedanib)|"AUC0-12,ss,norm of BIBF 1202 glucuronide (Metabolite of Nintedanib):
Detailed time points of sampling are:
Phase I and selected phase II patients in the Nintedanib arm:
Cycle 1, Day 15 to 16: Immediately prior to swallowing the dose of nintedanib (predose) and 1 hour (h), 2 h, 3 h, 4 h, 5 h, 7 h, 10 h, 12 h and 24 h after drug administration on Day 15; Cycle 2, Day 1: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 1; Cycle 2, Day 15: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 15."|Day1, Day15 and Day 16|Pharmacokinetic set (PKS): The PK set was a subset of the treated set and included all patients who received at least one dose of trial medication and for whom at least one PK observation was available.||(ng*h/mL)/mg||Geometric Coefficient of Variation|Geometric Mean
803982|NCT00987935|Secondary|AUC0-12,ss,Norm (Area Under the Plasma Concentration-time Curve Between 0 and 12 Hours at Steady State, Normalised Values) of BIBF 1202 (Metabolite of Nintedanib)|"AUC0-12,ss,norm (area under the plasma concentration-time curve between 0 and 12 hours at steady state, normalised values) of BIBF 1202 (metabolite of Nintedanib).
Detailed time points of sampling are:
Phase I and selected phase II patients in the Nintedanib arm:
Cycle 1, Day 15 to 16: Immediately prior to swallowing the dose of nintedanib (predose) and 1 hour (h), 2 h, 3 h, 4 h, 5 h, 7 h, 10 h, 12 h and 24 h after drug administration on Day 15; Cycle 2, Day 1: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 1; Cycle 2, Day 15: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 15."|Day1, Day15 and Day 16|Pharmacokinetic set (PKS): The PK set was a subset of the treated set and included all patients who received at least one dose of trial medication and for whom at least one PK observation was available.||(ng*h/mL)/mg||Geometric Coefficient of Variation|Geometric Mean
803983|NCT00987935|Secondary|AUC0-12,ss,Norm (Area Under the Plasma Concentration-time Curve Between 0 and 12 Hours at Steady State, Normalised Values) of Nintedanib|"AUC0-12,ss,norm (area under the plasma concentration-time curve between 0 and 12 hours at steady state, normalised values) of Nintedanib
Detailed time points of sampling are:
Phase I and selected phase II patients in the Nintedanib arm:
Cycle 1, Day 15 to 16: Immediately prior to swallowing the dose of nintedanib (predose) and 1 hour (h), 2 h, 3 h, 4 h, 5 h, 7 h, 10 h, 12 h and 24 h after drug administration on Day 15; Cycle 2, Day 1: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 1; Cycle 2, Day 15: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 15."|Day1, Day15 and Day 16|Pharmacokinetic set (PKS): The PK set was a subset of the treated set and included all patients who received at least one dose of trial medication and for whom at least one PK observation was available.||(ng*h/mL)/mg||Geometric Coefficient of Variation|Geometric Mean
803984|NCT00987935|Secondary|Overall Survival|Overall survival was defined as the duration from date of randomisation to the date of death.|From randomization until data cut-off (16 July 2014); Up to 171 weeks|Treated set, include only phase II participants||months||Inter-Quartile Range|Median
803985|NCT00987935|Secondary|Progression Free Survival (PFS)|PFS by RECIST 1.0 was defined as the duration from date of randomisation to date of progression or death, whichever occurred earlier, based on central independent review.|From randomization until data cut-off (16 July 2014); Up to 171 weeks|Treated set, only phase II participants.||months||Inter-Quartile Range|Median
803986|NCT00987935|Secondary|Objective Tumour Response by RECIST|"Objective RECIST 1.0 tumour response was defined as Complete Response (CR) or Partial Response (PR) and was derived from the patient's best objective RECIST 1.0 response based on central independent review.
95% Confidence Interval presented below are computed by Clopper and Pearson method."|From randomization until data cut-off (16 July 2014); Up to 171 weeks|Treated set, only phase II participants.||percentage of participants||95% Confidence Interval|Number
803987|NCT00987935|Secondary|Incidence of Dose Limiting Toxicity in Phase I|Number of patients with dose limiting toxicity are presented|4 weeks|Treated set (Phase I patients from the dose escalation part that were not replaced for MTD determination).||participants|||Number
803988|NCT00987935|Secondary|Incidence and Intensity of Adverse Events (AEs) Reported as the Number of Patients With AEs According to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Throughout the Treatment Period.|Incidence and worst intensity (severity) of Adverse Events with grading according to the Common Terminology Criteria for Adverse Events (CTCAE version 3.0).|AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)|Treated set||participants|||Number
803989|NCT00987935|Secondary|Time to Progression (TTP) in Phase II (Follow-up Analyses)|TTP according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.0 criteria based on central independent review. TTP RECIST 1.0 was defined as the time from randomisation to disease progression according to RECIST 1.0.|From randomization until disease progression or data cut-off (16 Jul 2014); Up to 171 weeks|Treated set, Only phase II participants||months||Inter-Quartile Range|Median
803990|NCT00987935|Primary|Time to Progression (TTP) in Phase II|TTP according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.0 criteria based on central independent review. TTP RECIST 1.0 was defined as the time from randomisation to disease progression according to RECIST 1.0.|From randomization until data cut-off (28 Sep 2012); Up to 77 weeks|Treated set, only phase II participants.||months||Inter-Quartile Range|Median
803991|NCT00987935|Primary|Maximum Tolerated Dose in Phase I|The MTD was defined as the highest dose studied for which the incidence of DLTs was 0/3 or less than 2/6 patients during the first treatment course.|4 weeks|Treated set (Patients from the dose escalation part that were not replaced for MTD determination)||mg|||Number
803992|NCT00987948|Secondary|Change From Baseline to 24 Weeks in Neuropsychological Performance As Measured by Age- and Education-Adjusted Z-Scores|The Z-score represents the number of standard deviations away from the mean, with positive Z-scores representing better neuropsychological performance and negative Z-scores representing poorer neuropsychological performance. Z-scores have been adjusted based on age- and education-matched norms.|Baseline to 24 Weeks|6 of 12 patients who completed the study who had mild to moderate cognitive impairment||Z-score||Inter-Quartile Range|Median
803993|NCT00987948|Primary|Change From Baseline to 24 Weeks in HIV DNA (Log-10 Copies/10^6 Cells) as Measured by HIV DNA Within CD14+ Peripheral Blood Mononuclear Cells|Week 24 minus baseline|Baseline to 24 weeks|Outcome measure in the 12 patients who completed the study.||Log-10 copies/10^6 cells||Inter-Quartile Range|Median
803995|NCT00988065|Secondary|The Percentage of Participants With Adjudicated Hypersensitivity Signs/Symptoms After Each Randomized Dose of Study Treatment, for Each Sugammadex Dose Group and Placebo.|"Hypersensitivity signs/symptoms were systematically collected for each subject by the investigator. Suspected cases of hypersensitivity signs/symptoms were sent to the independent Adjudication Committee (comprised of anesthesiologists & allergists/immunologists) for blinded review & determination of adjudicated hypersensitivity &/or anaphylaxis based on expert evaluation of all clinical data from the healthy subject.
The percentages of subjects who had adjudicated hypersensitivity (dose 1/Day 8, dose 2/Day 36, or dose 3/Day 78) are presented for each of the 3 treatment arms for each dose."|Day 8, Day 36, and Day 78 of the study|All-Subjects as treated, per dose (i.e. who received the corresponding dose of randomized study medication).||percentage of participants|||Number
803996|NCT00988065|Secondary|The Percentage of Participants With Each of the 3 Levels of Diagnostic Certainty of Adjudicated Anaphylaxis According to the Definition by Rüggeberg et al., for Each Sugammadex Dose Group and Placebo.|"The Adjudication Committee evaluated each case to determine anaphylaxis according to the criteria put forth by the guidelines of the Brighton Collaboration Anaphylaxis Working Group as described by Rüggeberg et al. (Vaccine 2007; 25:5675-5684).
Level 1 represents the highest level of certainty of anaphylaxis and level 3 the lowest level of certainty.
The percentages of subjects who had adjudicated anaphylaxis according to the Rüggeberg Criteria at any dose (dose 1 [~Day 8], dose 2 [~Day 36], or dose 3 [Day ~78]) were compared between the 3 treatment groups."|Day 8, Day 36, and Day 78 of the study|All-Subjects as treated (i.e., who received at least one dose of randomized study medication).||percentage of participants|||Number
803997|NCT00988065|Secondary|The Percentage of Participants With Adjudicated Anaphylaxis According to the Definition by Sampson et al., for Each Sugammadex Dose Group and Placebo.|"The Adjudication Committee evaluated each case to determine whether the subject's hypersensitivity sign/symptoms fulfilled the definition of anaphylaxis according to the criteria defined by the Symposium on the Definition and Management of Anaphylaxis as described by Sampson et al. (J Allergy Clin Immunol 2006; 117:391-7).
The percentages of subjects who had adjudicated anaphylaxis according to the Sampson Criteria at any dose (dose 1 [~Day 8], dose 2 [~Day 36], or dose 3 [Day ~78]) were compared between the 3 treatment groups."|Day 8, Day 36, and Day 78 of the study|All-Subjects as treated (i.e., who received at least one dose of randomized study medication).||percentage of participants||95% Confidence Interval|Number
803998|NCT00988065|Primary|The Percentage of Participants With Adjudicated Hypersensitivity Signs/Symptoms, for Each Sugammadex Dose Group and Placebo.|"Hypersensitivity signs/symptoms were systematically collected for each subject by the investigator. Suspected cases of hypersensitivity signs/symptoms were sent to the independent Adjudication Committee (comprised of anesthesiologists & allergists/immunologists) for blinded review and determination of adjudicated hypersensitivity &/or anaphylaxis based on expert evaluation of all clinical data from the healthy subject.
The percentages of subjects who had adjudicated hypersensitivity at any dose (dose 1/Day 8, dose 2/Day 36, or dose 3/Day 78) were compared between the 3 treatment groups."|Day 8, Day 36, and Day 78 of the study|All-Subjects as treated (i.e., who received at least one dose of randomized study medication).||percentage of participants||95% Confidence Interval|Number
803999|NCT00988091|Secondary|Percentage of Observed Osteoarthritis Research Society International (OARSI30) Responders Using the Visual Analogue Scale (VAS) to Assess Pain Following a 50-foot Walk at Week 26|Responders are identified based on a calculation of three scales: 50-foot walk test for pain, function (WOMAC Disability score) and global assessment (Patient Global Assessment Score) scales. Each of the individual scales was completed by the participant. A responder showed considerable improvement in pain or function (>=50 percent and absolute change of >=20 millimeters), or improvement in at least two of three categories: Pain and/or Function and/or Patient Global Assessment scales of >=20 percent and absolute change >=10 millimeter. Response at Week 26 is compared to baseline.|Day 0 (baseline), week 26|Intent to treat population||percentage of participants|||Number
804000|NCT00988091|Secondary|Change From Baseline in Patient Global Assessment at Week 26|Participants were asked to mark along a 100mm visual analog scale (VAS) indicating the point best representing the severity of the knee pain that day. The left side of the VAS was 0=no pain and the right side was 100 = extreme pain. Change from baseline was calculated as Week 26 - Baseline.|Day 0 (baseline), Week 26|Intent to treat population||units on a scale||Standard Error|Least Squares Mean
804001|NCT00988091|Secondary|Number of Tablets of Rescue Medication Used Between Visits|Acetaminophen (500-mg tablets) was provided to study participants as a rescue medication in case they needed a pain medication during the study. The mean number of tablets of rescue medication should have been summarized, however the data was not captured in a reliable way and is therefore not reported.|Day 1 to week 26|||tablets||Standard Deviation|Mean
804002|NCT00988091|Secondary|Subjective Patient Assessment of Treatment at Week 26|"At the end of the double-blind period (week 26), participants were asked: “Are you satisfied with the results of the injection? Answers could be: 1=dissatisfied; 2=slightly satisfied; 3=satisfied; or 4=very satisfied."|Week 26|Intent to treat population||units on a scale||Standard Deviation|Mean
804003|NCT00988091|Secondary|Percentage of Participants With a >=20mm Improvement Between Baseline and Week 26 on the 50 Foot Walk Visual Analogue Scale (VAS) Pain Score.|The level of pain is estimated by the participant following a walk of 50 feet in length which is observed by the investigator. Pain estimates were recorded on a 100 millimeter visual analog scale. A score of 0 millimeters means there was no pain; a score of 100 millimeters means extreme pain. Change from baseline is calculated: week 26 VAS Pain Score - Baseline VAS Pain Score. The percent of participants who showed a 20mm or greater improvement in the pain scores at week 26 compared to baseline are reported.|Day 0 (baseline), Week 26|Intent to treat population||percentage of participants|||Number
804004|NCT00988091|Secondary|Change From Baseline in Western Ontario McMaster University Osteoarthritis Index (WOMAC) Disability Scores at Week 26|Adjusted mean of all WOMAC pain, stiffness and physical function subscores on Visual Analog Scale (VAS) of 100 mm; 0 mm = no pain, stiffness and difficulty; 100 mm = extreme pain, stiffness and difficulty. Change from baseline calculated as: Week 26 minus baseline.|Day 0 (baseline), week 26|Intent to treat population||units on a scale||Standard Error|Least Squares Mean
804130|NCT00996892|Secondary|Tmax of Cobimetinib on Cycle 1 Day 1 – Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 15-17|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Median
804007|NCT00988117|Primary|Pre-post Change in Continuous Performance Test of Attention (Median Reaction Time)|On the Continuous Performance Test (CPT), subjects press the spacebar quickly when they see a target image (a white star; 150 trials), and withhold response when they see a non-target image (5 randomly sampled white shapes; 150 trials). The inter-stimulus interval is randomly sampled from 1.5s, 2.5s, or 4s. Performance is measured by the median reaction time (milliseconds) on accurate target trials.|Baseline and 12 weeks|Data were missing for two of the patients on the CPT post-treatment due to a computer error.||milliseconds||Full Range|Median
804008|NCT00988117|Primary|Resting State Functional Activity Change From Baseline to 12 Weeks|Fractional amplitude of low frequency fluctuations (fALFF) was used to measure brain activity. This metric is derived from task-free functional magnetic resonance imaging (fMRI) and represents the power of regional spontaneous and intrinsic brain activity at the local, voxel-wise level while the subject is at rest. More specifically, the amplitude of low-frequency fluctuations (ALFF) is the total power in the low-frequency range, and fALFF is calculated by dividing ALFF by the total power across all measurable frequencies. Whereas ALFF values increase near blood vessels and cerebrospinal fluid (CSF), likely due to pulsations in those areas, fALFF is less susceptible to artifactual signals. We measured change in these ratio scores post-treatment minus baseline and present in z-score units.|Baseline and 12 weeks|All patients who completed the study were included.||z-score||Standard Deviation|Mean
804009|NCT00988143|Primary|Geometric Mean Titers (GMTs) Against Influenza A Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine in Adult Participants.|Immunogenicity outcomes were assessed in serum samples by Hemagglutination inhibition (HAI) assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.|21 Days post last vaccination|Geometric mean titers to vaccine A strains were determined in the per-protocol population. For this outcome, the data for the A/Brisbane/59/2007(A1N1) and A/Uruguay/716/2007(H3N2) antibodies were pooled for participants vaccinated with either 2009-2010 TIV or 2008-2009 TIV and presented in the column for Study Group 1 (2009-2010 TIV).||Titers||95% Confidence Interval|Geometric Mean
804010|NCT00988143|Other Pre-specified|Number of Participants With Seroprotection to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines|"Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.
Seroprotection to vaccine antigens was defined as a pre-vaccination and post-vaccination titer value of titer ≥ 40 (1/dil)."|Day 0 (pre-vaccination) and Day 21 post final vaccination|Seroprotection to influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population||Participants|||Number
804011|NCT00988143|Other Pre-specified|Number of Participants With Seroconversion to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines|Seroconversion to vaccine antigens were defined as a pre-vaccination titer < 10 (1/dil) and a post-vaccination titer ≥ 40 (1/dil), or a pre-vaccination titer ≥ 10 (1/dil) and a ≥ 4-fold increase in post-vaccination titer.|Day 0 up to 21 days post-vaccination|Seroconversion with respects to influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population||Participants|||Number
804012|NCT00988143|Other Pre-specified|Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Study Participants|Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.|21 Days post last vaccination|Geometric mean titers to influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population||Titers||95% Confidence Interval|Geometric Mean
804013|NCT00988143|Other Pre-specified|Number of Adult Participants With Seroconversion to Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines|Seroconversion to vaccine antigens was defined as a pre-vaccination titer < 10 (1/dil) and a post-vaccination titer ≥ 40 (1/dil), or a pre-vaccination titer ≥ 10 (1/dil) and a ≥ 4-fold increase in post-vaccination titer.|Day 21 post-vaccination|Seroconversion with respect to vaccine antigens were determined in randomized and vaccinated participants, per-protocol population.||Participants|||Number
804014|NCT00988143|Other Pre-specified|Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Adult Participants|Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.|21 Days post last vaccination|Geometric mean titers to influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population||Titers||95% Confidence Interval|Geometric Mean
804015|NCT00988143|Other Pre-specified|Number of Adult Participants With Seroprotection Against Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine|"Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.
Seroprotection to vaccine antigens was defined as a pre-vaccination and post-vaccination titer value of titer ≥ 40 (1/dil)"|Day 0 (pre-vaccination) and Day 21 post final vaccination|Seroprotection against the influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population.||Participants|||Number
804016|NCT00988143|Primary|Geometric Mean Titers (GMTs) Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine in Adult Participants.|Immunogenicity outcomes were assessed in serum samples by Hemagglutination inhibition (HAI) assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.|21 Days post last vaccination|Geometric mean titers to vaccine B strains were determined in randomized and vaccinated participants, per-protocol population||Titers||95% Confidence Interval|Geometric Mean
804147|NCT00996892|Secondary|Cmax of Cobimetinib on Cycle 1 Day 1 – Stage 2 Individual Indication Specific Cohorts|Stage 2 PK data were reported for each indication specific cohort separately.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 14|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
804017|NCT00988143|Primary|Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines.|"Solicited injection site reactions (6-23 Months): Tenderness, Redness and Swelling; Solicited systemic reactions: Fever, Abnormal crying, Drowsiness, Loss of appetite, Vomiting and Irritability Grade 3 Tenderness: cries when injected limb is moved; Redness and Swelling: ≥5 cm; Fever: >103.1°F; Abnormal crying: >3 hours; Drowsiness: Sleeping most of the time; Loss of appetite: refuses ≥3 feeds/meals; Vomiting: ≥6 episodes/24 hours; Irritability: inconsolable.
(24-59 Months): Pain, Redness and Swelling; Fever, Headache, Malaise and Myalgia. Grade 3: Pain, Incapacitating; Redness and Swelling: ≥5 cm; Fever: >102.1°F, Headache, Malaise and Myalgia: Significant, prevents daily activity.
(Adults): Pain, Redness, Induration, and Ecchymosis; Fever, Headache, Malaise, Myalgia and Shivering.
Grade 3: Pain: significant, prevents daily activities; Redness, Swelling, Induration and Ecchymosis: >10 cm; Fever >102.1°F; Headache, Malaise, Myalgia & Shivering: Significant, prevents daily activity."|Day 0 up to 7 days post-vaccination|Solicited injection site and systemic reactions were assessed in all randomized and vaccinated participants, safety population.||Participants|||Number
804018|NCT00988156|Primary|Responder Rate|Responder rate defined as the number of patients with at least a 50% decrease in the standardised 4-week seizure frequency from the baseline period to the 12-week maintenance period.|baseline up to Visit 7|||participants|||Number
804019|NCT00988156|Primary|Change From Baseline in Seizure Frequency|Relative reduction in the standardised 4-week seizure frequency from the baseline period to the 12-week maintenance period.|Baseline up to Visit 7|||seizures/month||Standard Deviation|Mean
804020|NCT00988169|Primary|Radiographic Objective Response Rate|(CR+PR, by WHO Criteria for Standard Bidimensional Tumor Measurement) After One 21-day Cycle of Combination Therapy With Erlotinib and AT-101|21 days after cycle one|||participants|||Number
804021|NCT00988208|Secondary|Number of Participants With Treatment Emergent Adverse Events (AEs)|A TEAE is defined as any AE occurring or worsening on or after the first dose of study drug and within 28 days after the last dose of study drug. A TESAE is defined as any serious adverse event (SAE) occurring or worsening on or after the first dose of study drug and within 28 days after the last dose of study drug. Safety and Severity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0; Severity of AEs were graded (including second primary malignancies) as Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe; Grade 4- Life-threatening; Grade 5-Fatal;|The maximum duration on study drug was 93 weeks, which includes the time from the first dose of study drug administration to 28 days after the last dose of study drug and up to the data cut-off date of 13 January 2012|The Safety Population is defined as all randomized participants who receive at least one dose of the study treatment (lenalidomide/placebo, Docetaxel, or Prednisone).||participants|||Number
804022|NCT00988208|Secondary|Objective Response Rate (ORR) of Measurable and/or Non-measurable Disease as Determined by Investigators According to RECIST Version 1.1 Criteria|Objective response (OR) is defined as having complete response (CR) or partial response (PR) as best overall response. RECIST Criteria 1.1 defines a CR = Disappearance of all target lesions except lymph nodes (LN); LN must have a decrease in the short axis to <10mm; PR = 30% decrease in sum of diameters of target lesions taking as reference the baseline sum diameters; Progressed Disease (PD) = 20% increase in sum of diameters of target lesions taking as a reference the smallest sum of diameters and an absolute increase of ≥5 mm; the appearance of ≥1 new lesions; Stable Disease (SD)= Neither shrinkage to qualify for PR nor increase to qualify for PD taking the smallest sum diameters on study as reference. For non-target lesions a CR = Disappearance of all non-target lesions and all LN must be non-pathological in size <10 mm; Non-CR/Non PD: persistence of one or more non-target lesions; PD = unequivocal progression of existing non-target lesions or appearance of new ones|Day 1 to data cut-off 13 January 2012; maximum time on study approximately 26 months|Based on the ITT population||participants|||Number
804023|NCT00988208|Secondary|Progression-free Survival (PFS)|PFS was the time from randomization to disease progression, or death, whatever occurred first. Progression criteria was met by analysis of target and non-target lesions as defined by RECIST Version 1.1 criteria. Progressive Disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum of the diameters while on study or the appearance of one or more new lesions; an increase of at least 5mm as a total sum. Lymph nodes identified as target lesions (≥ 15 mm diameter in short axis) will be followed and reported by changes in diameter of short axis; or the unequivocal progression of a non-target lesion defined as an increase in the overall disease burden based on the change in non-measurable disease that is comparable in scope to the increase required to declare PD for measurable disease; Two or more new bone lesions as detected by bone scan|Randomization until disease progression or death from any cause up to cut-off date of 13 Jan 2012; maximum time on study approximately 26 months|Based on the Intent to treat population (ITT)||Weeks||95% Confidence Interval|Median
804024|NCT00988208|Primary|Overall Survival (OS)|Overall survival (OS) was the time from the date of randomization to the date of death from any cause. If no death was reported for a participant before the cut-off date for OS analysis, OS was censored at the last date at which the participant was alive. The median OS was calculated based on Kaplan-Meier estimates and corresponding 95% confidence interval (CI) was calculated using the method provided by Brookmeyer and Crowley.|Randomization until death from any cause up to the cut-off date of 13 January 2012|Time to Death in Weeks; efficacy analysis was based on the Intention-to-Treat population (ITT), defined as all randomized patients irrespective of whether they received treatment or not.||weeks||95% Confidence Interval|Median
804025|NCT00988221|Secondary|Height Standard Deviation Score at Baseline, Week 52, and Week 104|The height Standard Deviation Score was calculated using the following formula: (Observed height - median of the reference population)/standard deviation of the reference population. The reference population was defined as that of the same sex and age to the nearest completed year and month using the World Health Organization norms. A negative score indicates less height than the reference population.|Baseline to Week 104|Growth population: All participants who received at least 1 dose of tocilizumab but who did not take the growth hormone somatotropin.||Standard deviation score||Standard Deviation|Mean
804148|NCT00996892|Secondary|Tmax of Cobimetinib on Cycle 1 Day 1 – Stage 2 Individual Indication Specific Cohorts|Stage 2 PK data were reported for each indication specific cohort separately.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 14|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Median
804026|NCT00988221|Secondary|Methotrexate Dose at Baseline, Week 52, and Week 104|Values are based on the average daily dose on the study day and if not available the last observation carried forward is used.|Baseline to Week 104|All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. Each visit includes patients with a non-missing assessment at the time point. Patients who previously withdrew are excluded.||mg/m^2/week||Standard Deviation|Mean
804027|NCT00988221|Secondary|Oral Corticosteroid Dose at Baseline, Week 52, and Week 104|Due to the different types of corticosteroid medications available, the prednisone equivalent was used in the calculation of the oral corticosteroid dose. Values are based on the average daily dose on the study day and if not available the last observation carried forward is used.|Baseline to Week 104|All exposure safety population: All patients randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. Each visit includes patients with a non-missing assessment at the time point. Patients who previously withdrew are excluded.||mg/kg/day||Standard Deviation|Mean
804028|NCT00988221|Secondary|Percent of Patients Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at Week 104 by Duration of Disease (< 2 Years, ≥ 2 Years)|A JIA ACR30/50/70/90 response is defined as a ≥ 30/50/70/90% response on 3 of 6 variables and no more than 1 of the remaining variables worsening > 30%. The 6 variables are physician global assessment of disease activity (20 units minimum on a 0-100 visual analog scale [VAS]), parent/patient global assessment of overall well-being (20 VAS units minimum), number of joints (minimum of 2 worse) with active arthritis (swelling, or pain and limitation of motion), number of joints (minimum of 2 worse) with limitation of movement, erythrocyte sedimentation rate, and functional ability assessed using the disability index of the Childhood Health Assessment Questionnaire (CHAQ, 30 questions, 8 domains, 0[best]-3[worst]). Patients who withdrew due to non-safety reasons are classified as non-responders.|Baseline to Week 104|Continuous tocilizumab population: Patients randomized to tocilizumab in Part II of the study and who therefore received tocilizumab throughout the study. Patients who withdrew due to safety have their last available response prior to withdrawal carried forward. Last observation carried forward applied to missing core components at visits.||Percent of patients|||Number
804029|NCT00988221|Secondary|Percent of Patients in Clinical Remission From Week 40 to 104|A patient was in clinical remission if they had inactive disease at all visits in the 6 months prior to and including the visit assessment day. A patient was judged to have inactive disease if all of the following criteria were met: Number of joints with active arthritis = 0; absence of active uveitis, defined by the adverse event preferred terms ‘uveitis’ and ‘intermediate uveitis’; normal erythrocyte sedimentation rate (< 20 mm/hour regardless of age and sex); and physician’s global assessment of overall well-being visual analog scale score ≤ 10. Patients who withdrew due to non-safety reasons are classified as non-responders.|Week 40 to Week 104|Continuous tocilizumab population: Patients randomized to tocilizumab in Part II of the study and who therefore received tocilizumab throughout the study. Patients who withdrew due to safety have their last available response prior to withdrawal carried forward. Last observation carried forward applied to missing core components at visits.||Percent of patients|||Number
804030|NCT00988221|Secondary|Percent of Patients With Inactive Disease From Week 16 to Week 104|A patient is judged to have inactive disease if all of the following criteria are met: Number of joints with active arthritis = 0; absence of active uveitis, defined by the adverse event preferred terms ‘uveitis’ and ‘intermediate uveitis’; normal erythrocyte sedimentation rate (< 20 mm/hour regardless of age and sex); and physician’s global assessment of overall well-being visual analog scale score ≤ 10. Patients who withdrew due to non-safety reasons are classified as non-responders.|Week 16 to Week 104|Continuous tocilizumab population: Patients randomized to tocilizumab in Part II of the study and who therefore received tocilizumab throughout the study. Patients who withdrew due to safety have their last available response prior to withdrawal carried forward. Last observation carried forward applied to missing core components at visits.||Percent of patients|||Number
804031|NCT00988221|Secondary|Change From Baseline in the Pain Visual Analogue Scale (VAS) Score at Weeks 2, 40, 52, and 104|The patient or parent/guardian, as appropriate, provides a rating of the patient’s pain (also called a discomfort index) on a 0 to 100 mm horizontal scale. The extreme left end of the line represents ‘no pain’ and the extreme right end represents ‘very extreme pain’. A higher score indicates more pain. A negative change score indicates improvement.|Baseline to Week 104|Continuous tocilizumab population: Patients randomized to tocilizumab in Part II of the study and who therefore received tocilizumab throughout the study. Each visit includes patients with a non-missing assessment at the time point. Patients who previously withdrew are excluded. Patients without a Baseline assessment are excluded.||Units on a scale||Standard Deviation|Mean
804032|NCT00988221|Secondary|C-reactive Protein Levels From Baseline to Week 104|C-reactive protein (CRP), an acute phase protein, was measured in blood samples with a high-sensitivity CRP (hs-CRP) test using laser nephelometry.|Baseline to Week 104|Continuous tocilizumab population: Patients randomized to tocilizumab in Part II of the study and who therefore received tocilizumab throughout the study. Each visit includes patients with a non-missing assessment at the time point. Patients who previously withdrew are excluded.||mg/L||Standard Deviation|Mean
804040|NCT00988221|Secondary|Change From Baseline in the Juvenile Arthritis Disease Activity Score-71 (JADAS-71) at Week 104|The JADAS-71 is composed of 4 components: Physician global assessment of disease activity on a visual analog scale (VAS) (range = 0-10, left end of the line = arthritis inactive, ie, symptom-free and no arthritis symptoms; right end = arthritis very active), patient/parent global assessment of overall well-being on a VAS (range = 0-10, left end of the line = very well, ie, symptom-free and no arthritis disease activity; right end = very poor, ie, maximum arthritis disease activity), normalized erythrocyte sedimentation rate (ESR) (range = 0-10, If ESR is ≤ 20 mm/h, set to 0. If ≥ 120 mm/h, set to 10 mm/h. If > 20 mm/h and < 120 mm/h, apply formula: [ESR − 20 mm/h]/10 mm/h), and a count of active arthritis (swelling present or pain present and limitation of motion) in 71 selected joints (range=0-71). The JADAS-71 is the sum of the 4 component scores and ranges from 0-101. A higher score indicates more arthritis disease activity. A positive change score indicates improvement.|Baseline to Week 104|Continuous tocilizumab population: Patients randomized to tocilizumab in Part II of the study and who therefore received tocilizumab throughout the study. Only patients with non-missing data were included in the analysis.||Units on a scale||Standard Deviation|Mean
804033|NCT00988221|Secondary|Percent of Patients With a Minimally Important Improvement in the Children’s Health Assessment Questionnaire-Disability Index (CHAQ-DI) Score at Weeks 16, 40, 52, 80, and 104|The CHAQ-DI consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. There are 4 possible responses to each question (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do). A domain score is the highest score in that domain. If aids and devices listed in the questionnaire or assistance from a person are required to perform a task, a domain score of 0 or 1 is increased to 2; if the domain score is 2 or 3, the domain score is not adjusted. To calculate the overall score, the patient must have a domain score in at least 6 of the 8 domains. The CHAQ-DI score is the sum of the domain scores divided by the number of domains that have a non-missing score and ranges from 0 (best) to 3 (worst). A minimally important improvement is an improvement ≥ 0.13 over Baseline. Patients who withdrew due to non-safety reasons are classified as non-responders.|Baseline to Week 104|Continuous tocilizumab population: Patients randomized to tocilizumab in Part II of the study and who therefore received tocilizumab throughout the study. Patients who withdrew due to non-safety reasons are classified as non-responders. Patients who withdrew due to safety have their last available response prior to withdrawal carried forward.||Percent of patients|||Number
804034|NCT00988221|Secondary|Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Functional Ability at Week 104|Functional ability is assessed with the Childhood Health Assessment Questionnaire (CHAQ-DI) disability index which consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. There are 4 possible responses to each question (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do). A domain score is the highest score in that domain. If aids and devices listed in the questionnaire or assistance from a person are required to perform a task, a domain score of 0 or 1 is increased to 2; if the domain score is 2 or 3, the domain score is not adjusted. To calculate the overall score, the patient must have a domain score in at least 6 of the 8 domains. The CHAQ-DI score is the sum of the domain scores divided by the number of domains that have a non-missing score and ranges from 0 (best) to 3 (worst). A negative change score indicates improvement.|Baseline to Week 104|Continuous tocilizumab population: Patients randomized to tocilizumab in Part II of the study and who therefore received tocilizumab throughout the study. Each visit includes patients with a non-missing assessment at the time point. Patients who previously withdrew are excluded. Patients without a Baseline assessment are excluded.||Percent change||Standard Deviation|Mean
804035|NCT00988221|Secondary|Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Erythrocyte Sedimentation Rate (ESR) at Week 104|Erythrocyte sedimentation rate, an acute phase protein, was measured using a kit furnished by the study central laboratory. A negative change score indicates improvement.|Baseline to Week 104|Continuous tocilizumab population: Patients randomized to tocilizumab in Part II of the study and who therefore received tocilizumab throughout the study. Each visit includes patients with a non-missing assessment at the time point. Patients who previously withdrew are excluded. Patients without a Baseline assessment are excluded.||Percent change||Standard Deviation|Mean
804036|NCT00988221|Secondary|Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Number of Joints With Limitation of Movement at Week 104|Joints with limitation of movement are defined as joints with limitation of motion. The maximum number of joints with limitation of movement is 67. The joint assessment is performed by an independent assessor who is not the treating physician and who is blinded to all other aspects of the patient’s efficacy and safety data. A negative change score indicates improvement.|Baseline to Week 104|Continuous tocilizumab population: Patients randomized to tocilizumab in Part II of the study and who therefore received tocilizumab throughout the study. Each visit includes patients with a non-missing assessment at the time point. Patients who previously withdrew are excluded. Patients without a Baseline assessment are excluded.||Percent change||Standard Deviation|Mean
804037|NCT00988221|Secondary|Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Number of Joints With Active Arthritis at Week 104|Joints with active arthritis are defined as joints with swelling present or pain present and limitation of motion. The maximum number of joints with active arthritis is 71. The joint assessment is performed by an independent assessor who is not the treating physician and who is blinded to all other aspects of the patient’s efficacy and safety data. A negative change score indicates improvement.|Baseline to Week 104|Continuous tocilizumab population: Patients randomized to tocilizumab in Part II of the study and who therefore received tocilizumab throughout the study. The analysis excluded patients without a Baseline assessment or who had withdrawn.||Percent change||Standard Deviation|Mean
804038|NCT00988221|Secondary|Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Patient/Parent Global Assessment of Overall Well-being at Week 104|The patient or parent/guardian, as appropriate, provides a rating of the patient’s well-being on a 0 to 100 mm horizontal scale. The extreme left end of the line represents ‘very well’ (ie, symptom-free and no arthritis disease activity) and the extreme right end represents ‘very poor’ (ie, maximum arthritis disease activity). A negative change score indicates improvement.|Baseline to Week 104|Continuous tocilizumab population: Patients randomized to tocilizumab in Part II of the study and who therefore received tocilizumab throughout the study. The analysis excluded patients without a Baseline assessment or who had withdrawn.||Percent change||Standard Deviation|Mean
804039|NCT00988221|Secondary|Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Physician Global Assessment of Disease Activity at Week 104|The patient’s treating physician provides a rating of the patient’s arthritis disease activity on a 0 to 100 mm horizontal scale. The extreme left end of the line represents ‘arthritis inactive’ (ie, symptom-free and no arthritis symptoms) and the extreme right end represents ‘arthritis very active’. A negative change score indicates improvement.|Baseline to Week 104|Continuous tocilizumab population: Patients randomized to tocilizumab in Part II of the study and who therefore received tocilizumab throughout the study. The analysis excluded patients without a Baseline assessment or who had withdrawn.||Percent change||Standard Deviation|Mean
804094|NCT00988351|Primary|Positive Airway Pressure Adherence (Nightly Use of Treatment)|average nightly hours of using positive airway pressure (including 0 for nights not used)|6 weeks after starting treatment|patients using cpap or apap at clinic visit||hours||Standard Deviation|Mean
804041|NCT00988221|Secondary|Percent of Patients With 4 Baseline Disease Characteristics Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at Week 104|A JIA ACR30/50/70/90 response is defined as a ≥ 30/50/70/90% response on 3 of 6 variables and no more than 1 of the remaining variables worsening > 30%. The 6 variables are physician global assessment of disease activity (20 units minimum on a 0-100 visual analog scale), parent/patient global assessment of overall well-being (20 VAS units minimum), number of joints (minimum of 2 worse) with active arthritis (swelling, or pain and limitation of motion), number of joints (minimum of 2 worse) with limitation of movement, erythrocyte sedimentation rate, and functional ability assessed using the disability index of the Childhood Health Assessment Questionnaire (CHAQ, 30 questions, 8 domains, 0[best]-3[worst]). Results are reported for the subgroups: Previous biologic treatment (yes/no), concomitant methotrexate use (yes/no), rheumatoid factor (positive/negative), concomitant oral corticosteroid use (yes/no). Last observation carried forward was applied to missing components at visits.|Week 104|Continuous tocilizumab population: Patients randomized to tocilizumab in Part II of the study and who therefore received tocilizumab throughout the study. Patients who withdrew due to non-safety reasons are classified as non-responders. Patients who withdrew due to safety have their last available response prior to withdrawal carried forward.||Percent of patients|||Number
804042|NCT00988221|Secondary|Percent of Patients Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at Weeks 2, 52, and 104|A JIA ACR30/50/70/90 response is defined as a ≥ 30/50/70/90% response on 3 of 6 variables and no more than 1 of the remaining variables worsening > 30%. The 6 variables are physician global assessment of disease activity (20 units minimum on a 0-100 visual analog scale [VAS]), parent/patient global assessment of overall well-being (20 VAS units minimum), number of joints (minimum of 2 worse) with active arthritis (swelling, or pain and limitation of motion), number of joints (minimum of 2 worse) with limitation of movement, erythrocyte sedimentation rate, and functional ability assessed using the disability index of the Childhood Health Assessment Questionnaire (CHAQ, 30 questions, 8 domains, 0[best]-3[worst]).|Week 2 to Week 104|Continuous tocilizumab population: Patients randomized to tocilizumab in Part II of the study and who therefore received tocilizumab throughout the study.||Percent of patients|||Number
804043|NCT00988221|Secondary|Percent of Patients With Inactive Disease at the End of Part II of the Study (Week 40)|"A patient is judged to have inactive disease if all of the following criteria are met: Number of joints with active arthritis = 0; absence of active uveitis, defined by the adverse event preferred terms ‘uveitis’ and ‘intermediate uveitis’; normal erythrocyte sedimentation rate (< 20 mm/hour regardless of age and sex); and physician’s global assessment of overall well-being visual analog scale score ≤ 10.
The statistical test is not significant due to a break in the hierarchical chain of significance testing."|Week 40|Intent-to-treat population-2: All eligible patients completing Part I of the study who were randomized into Part II of the study and received at least 1 dose of tocilizumab in Part II.||Percent of patients||95% Confidence Interval|Number
804044|NCT00988221|Secondary|Change From Baseline in the Pain Visual Analogue Scale (VAS) Score at the End of Part II of the Study (Week 40)|The patient or parent/guardian, as appropriate, provides a rating of the patient’s pain (also called a discomfort index) on a 0 to 100 mm horizontal scale. The extreme left end of the line represents ‘no pain’ and the extreme right end represents ‘very extreme pain’. A higher score indicates more pain. A negative change score indicates improvement. Change from baseline was calculated using last observation carried forward (LOCF) imputation for missing values. The analysis was adjusted for the randomization stratification factors background use of methotrexate and background use of oral corticosteroids, and the pain visual analog scale score at Baseline. The adjusted means from the fitted model are presented.|Baseline to Week 40|Intent-to-treat population-2: All eligible patients completing Part I of the study who were randomized into Part II of the study and received at least 1 dose of tocilizumab in Part II.||Units on a scale||Standard Deviation|Mean
804045|NCT00988221|Secondary|Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Childhood Health Assessment Questionnaire-Disability Index (CHAQ-DI) at the End of Part II of the Study (Week 40)|The Childhood Health Assessment Questionnaire-Disability Index (CHAQ-DI), as a measure of functional ability, consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. There are 4 possible responses to each question (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do). A domain score is the highest score in that domain. To calculate the overall score, the patient must have a domain score in at least 6 of the 8 domains. The CHAQ-DI score is the sum of the domain scores divided by the number of domains that have a non-missing score and ranges from 0 (best) to 3 (worst). A higher score indicates less ability. A negative change score indicates improvement. Change from baseline was calculated using last observation carried forward imputation for missing values.|Baseline to Week 40|Intent-to-treat population-2: All eligible patients completing Part I of the study who were randomized into Part II of the study and received at least 1 dose of tocilizumab in Part II.||Units on a scale||Standard Deviation|Mean
804046|NCT00988221|Secondary|Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Erythrocyte Sedimentation Rate (ESR) at the End of Part II of the Study (Week 40)|Erythrocyte sedimentation rate, an acute phase protein, was measured using a kit furnished by the study central laboratory. A negative change score indicates improvement. Change from baseline was calculated using last observation carried forward imputation for missing values.|Baseline to Week 40|Intent-to-treat population-2: All eligible patients completing Part I of the study who were randomized into Part II of the study and received at least 1 dose of tocilizumab in Part II.||mm/hour||Standard Deviation|Mean
804047|NCT00988221|Secondary|Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Number of Joints With Limitation of Movement at the End of Part II of the Study (Week 40)|Joints with limitation of movement are defined as joints with limitation of motion. The maximum number of joints with limitation of movement is 67. The joint assessment is performed by an independent assessor who is not the treating physician and who is blinded to all other aspects of the patient’s efficacy and safety data. A negative change score indicates improvement. Change from baseline was calculated using last observation carried forward imputation for missing values.|Baseline to Week 40|Intent-to-treat population-2: All eligible patients completing Part I of the study who were randomized into Part II of the study and received at least 1 dose of tocilizumab in Part II.||Joints||Standard Deviation|Mean
804048|NCT00988221|Secondary|Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Number of Joints With Active Arthritis at the End of Part II of the Study (Week 40)|Joints with active arthritis are defined as joints with swelling present or pain present and limitation of motion. The maximum number of joints with active arthritis is 71. The joint assessment is performed by an independent assessor who is not the treating physician and who is blinded to all other aspects of the patient’s efficacy and safety data. A negative change score indicates improvement. Change from baseline was calculated using last observation carried forward imputation for missing values.|Baseline to Week 40|Intent-to-treat population-2: All eligible patients completing Part I of the study who were randomized into Part II of the study and received at least 1 dose of tocilizumab in Part II.||Joints||Standard Deviation|Mean
804049|NCT00988221|Secondary|Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Patient/Parent Global Assessment of Overall Well-being at the End of Part II of the Study (Week 40)|The patient or parent/guardian, as appropriate, provides a rating of the patient’s well-being on a 0 to 100 mm horizontal scale. The extreme left end of the line represents ‘very well’ (ie, symptom-free and no arthritis disease activity) and the extreme right end represents ‘very poor’ (ie, maximum arthritis disease activity). A higher score indicates poorer well-being. A negative change score indicates improvement. Change from baseline was calculated using last observation carried forward imputation for missing values.|Baseline to Week 40|Intent-to-treat population-2: All eligible patients completing Part I of the study who were randomized into Part II of the study and received at least 1 dose of tocilizumab in Part II.||Units on a scale||Standard Deviation|Mean
804050|NCT00988221|Secondary|Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Physician Global Assessment of Disease Activity at the End of Part II of the Study (Week 40)|The patient’s treating physician provides a rating of the patient’s arthritis disease activity on a 0 to 100 mm horizontal scale. The extreme left end of the line represents ‘arthritis inactive’ (ie, symptom-free and no arthritis symptoms) and the extreme right end represents ‘arthritis very active’. A higher score indicates more disease activity. A negative change score indicates improvement. Change from baseline was calculated using last observation carried forward imputation for missing values.|Baseline to Week 40|Intent-to-treat population-2: All eligible patients completing Part I of the study who were randomized into Part II of the study and received at least 1 dose of tocilizumab in Part II.||Units on a scale||Standard Deviation|Mean
804051|NCT00988221|Secondary|Percent of Patients Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at the End of Part II of the Study (Week 40)|A JIA ACR30/50/70/90 response is defined as a ≥ 30/50/70/90% response on 3 of 6 variables and no more than 1 of the remaining variables worsening > 30%. The 6 variables are physician global assessment of disease activity (20 units minimum on a 0-100 visual analog scale [VAS]), parent/patient global assessment of overall well-being (20 VAS units minimum), number of joints (minimum of 2 worse) with active arthritis (swelling, or pain and limitation of motion), number of joints (minimum of 2 worse) with limitation of movement, erythrocyte sedimentation rate, and functional ability assessed using the disability index of the Childhood Health Assessment Questionnaire (CHAQ, 30 questions, 8 domains, 0[best]-3[worst]). The analysis used the Cochran-Mantel-Haenszel test with the stratification variables background use of methotrexate and oral corticosteroids applied at Week 16.|Week 40|Intent-to-treat population-2: All eligible patients completing Part I of the study who were randomized into Part II of the study and received at least 1 dose of tocilizumab in Part II.||Percent of patients||95% Confidence Interval|Number
804052|NCT00988221|Secondary|Percent of Patients With an Elevated White Blood Count at Baseline That Had Normalized at the End of Part I of the Study (Week 16)|White blood cells were measured in blood samples taken from the patients.|Baseline to Week 16|Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab.||Percent of patients|||Number
804053|NCT00988221|Secondary|Percent of Patients With an Elevated Platelet Count at Baseline That Had Normalized at the End of Part I of the Study (Week 16)|Platelets were measured in blood samples taken from the patients.|Baseline to Week 16|Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab.||Percent of patients|||Number
804054|NCT00988221|Secondary|Percent of Patients With an Elevated Erythrocyte Sedimentation Rate at Baseline That Had Normalized at the End of Part I of the Study (Week 16)|Erythrocyte sedimentation rate, an acute phase protein, was measured using a kit furnished by the study central laboratory.|Baseline to Week 16|Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab.||Percent of patients|||Number
804055|NCT00988221|Secondary|Percent of Patients With an Elevated C-reactive Protein Concentration at Baseline That Had Normalized at the End of Part I of the Study (Week 16)|C-reactive protein (CRP), an acute phase protein, was measured in blood samples with a high-sensitivity CRP (hs-CRP) test using laser nephelometry.|Baseline to Week 16|Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab.||Percent of patients|||Number
804056|NCT00988221|Secondary|Percent of Patients With Inactive Disease at the End of Part I of the Study (Week 16)|A patient is judged to have inactive disease if all of the following criteria are met: Number of joints with active arthritis = 0; absence of active uveitis, defined by the adverse event preferred terms ‘uveitis’ and ‘intermediate uveitis’; normal erythrocyte sedimentation rate (< 20 mm/hour regardless of age and sex); and physician’s global assessment of overall well-being visual analog scale score ≤ 10.|Week 16|Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab.||Percent of patients|||Number
804057|NCT00988221|Secondary|Pain Visual Analogue Scale (VAS) Score at the End of Part I of the Study (Week 16)|The patient or parent/guardian, as appropriate, provides a rating of the patient’s pain (also called a discomfort index) on a 0 to 100 mm horizontal scale. The extreme left end of the line represents ‘no pain’ and the extreme right end represents ‘very extreme pain’. A higher score indicates more pain.|Week 16|Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab.||Units on a scale||Standard Deviation|Mean
812473|NCT01070784|Primary|Clinical Laboratory Test: Haematology -Haemoglobin|Change from baseline|Baseline and 52 week after|||g/dL||Standard Deviation|Mean
804058|NCT00988221|Secondary|Juvenile Arthritis Disease Activity Score (JADAS-27) at the End of Part I of the Study (Week 16)|The JADAS-27 is derived from the following components: Physician’s global assessment of disease activity on a 0-100 mm visual analog scale (VAS)/10, patient/parent’s global assessment of overall well-being on a 0-100 mm VAS/10, normalized erythrocyte sedimentation rate (ESR) (if ESR is ≤ 20 then set to 0, if ≥ 120 then set to 10, and if > 20 and < 120 then apply formula [ESR-20]/10), and number of joints (maximum of 27) with active arthritis (cervical spine, left/right elbow, left/right wrist, left/right MCP1-3, left/right PIP1-5, left/right hips, left/right knee and left/right ankle). The scores for the first 3 components range from 0-10; the score for the final component ranges from 0-27. The overall JADAS-27 score ranges from 0-57. A higher score indicates more disease activity.|Week 16|Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab.||Units on a scale||Standard Deviation|Mean
804059|NCT00988221|Secondary|Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Functional Ability at the End of Part I of the Study (Week 16)|Functional ability is assessed with the Childhood Health Assessment Questionnaire (CHAQ-DI) disability index which consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. There are 4 possible responses to each question (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do). A domain score is the highest score in that domain. If aids and devices listed in the questionnaire or assistance from a person are required to perform a task, a domain score of 0 or 1 is increased to 2; if the domain score is 2 or 3, the domain score is not adjusted. To calculate the overall score, the patient must have a domain score in at least 6 of the 8 domains. The CHAQ-DI score is the sum of the domain scores divided by the number of domains that have a non-missing score and ranges from 0 (best) to 3 (worst). A higher score indicates less ability. A negative change score indicates improvement.|Baseline to Week 16|Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab.||Percent change||Standard Deviation|Mean
804060|NCT00988221|Secondary|Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Erythrocyte Sedimentation Rate (ESR) at the End of Part I of the Study (Week 16)|Erythrocyte sedimentation rate, an acute phase protein, was measured using a kit furnished by the study central laboratory. A negative change score indicates improvement.|Baseline to Week 16|Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab.||Percent change||Standard Deviation|Mean
804061|NCT00988221|Secondary|Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Number of Joints With Limitation of Movement at the End of Part I of the Study (Week 16)|Joints with limitation of movement are defined as joints with limitation of motion. The maximum number of joints with limitation of movement is 67. The joint assessment is performed by an independent assessor who is not the treating physician and who is blinded to all other aspects of the patient’s efficacy and safety data. A negative change score indicates improvement.|Baseline to Week 16|Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab.||Percent change||Standard Deviation|Mean
804062|NCT00988221|Secondary|Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Number of Joints With Active Arthritis at the End of Part I of the Study (Week 16)|Joints with active arthritis are defined as joints with swelling present or pain present and limitation of motion. The maximum number of joints with active arthritis is 71. The joint assessment is performed by an independent assessor who is not the treating physician and who is blinded to all other aspects of the patient’s efficacy and safety data. A negative change score indicates improvement.|Baseline to Week 16|Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab.||Percent change||Standard Deviation|Mean
804063|NCT00988221|Secondary|Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Patient/Parent Global Assessment of Overall Well-being at the End of Part I of the Study (Week 16)|The patient or parent/guardian, as appropriate, provides a rating of the patient’s well-being on a 0 to 100 mm horizontal scale. The extreme left end of the line represents ‘very well’ (ie, symptom-free and no arthritis disease activity) and the extreme right end represents ‘very poor’ (ie, maximum arthritis disease activity). A higher score indicates poorer well-being. A negative change score indicates improvement.|Baseline to Week 16|Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab.||Percent change||Standard Deviation|Mean
804064|NCT00988221|Secondary|Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Physician Global Assessment of Disease Activity at the End of Part I of the Study (Week 16)|The patient’s treating physician provides a rating of the patient’s arthritis disease activity on a 0 to 100 mm horizontal scale. The extreme left end of the line represents ‘arthritis inactive’ (ie, symptom-free and no arthritis symptoms) and the extreme right end represents ‘arthritis very active’. A higher score indicates more disease activity. A negative change score indicates improvement.|Baseline to Week 16|Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab.||Percent change||Standard Deviation|Mean
804065|NCT00988221|Secondary|Percent of Patients Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses in Part I of the Study (Baseline to Week 16)|A JIA ACR30/50/70/90 response is defined as a ≥ 30/50/70/90% response on 3 of 6 variables and no more than 1 of the remaining variables worsening > 30%. The 6 variables are physician global assessment of disease activity (20 units minimum on a 0-100 visual analog scale [VAS]), parent/patient global assessment of overall well-being (20 VAS units minimum), number of joints (minimum of 2 worse) with active arthritis (swelling, or pain and limitation of motion), number of joints (minimum of 2 worse) with limitation of movement, erythrocyte sedimentation rate, and functional ability assessed using the disability index of the Childhood Health Assessment Questionnaire (CHAQ, 30 questions, 8 domains, 0[best]-3[worst]).|Baseline to Week 16|Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab.||Percent of patients|||Number
804066|NCT00988221|Primary|Percent of Patients With a Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30 (ACR30) Flare in Part II of the Study (Weeks 16-40)|JIA ACR30 flare is defined as a ≥ 30% worsening of 3 of 6 variables and no more than 1 of the remaining variables improving > 30%. The 6 variables are physician global assessment of disease activity (worsening of 20 units minimum on a 0-100 visual analog scale [VAS]), parent/patient global assessment of overall well-being (worsening of 20 VAS units minimum), number of joints (minimum of 2 worse) with active arthritis (swelling, or pain and limitation of motion), number of joints (minimum of 2 worse) with limitation of movement, erythrocyte sedimentation rate, and functional ability assessed using the disability index of the Childhood Health Assessment Questionnaire (CHAQ, 30 questions, 8 domains, 0[best]-3[worst]). Patients who withdrew or who took escape medication are classified as flared. The analysis used the Cochran-Mantel-Haenszel test with the stratification variables background use of methotrexate and oral corticosteroids applied at Week 16.|Week 16 through Week 40|Intent-to-treat population-2: All eligible patients completing Part I of the study who were randomized into Part II of the study and received at least 1 dose of tocilizumab in Part II.||Percent of patients||95% Confidence Interval|Number
804067|NCT00988247|Secondary|Change From Baseline to Week 52 in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in Participants With Impaired Quality of Life at Baseline|"The adult RQLQ has 28 questions in 7 domains (activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional). Participants were asked to recall their experiences during the previous week and to give their responses on a 7-point scale (0 = Least severe to 6 = Extremely severe). The overall RQLQ score is the mean of all 28 responses, and ranges from 0 to 7.
Week 52 scores were compared to baseline scores. A negative change score indicates improvement."|Day 0 (Baseline) and Week 52|The RQLQ population included only those participants over the age of 18 years with an impaired quality of life at Baseline as defined by a RQLQ score at Day 0 of 3.0 or greater.||units on a scale||Standard Error|Least Squares Mean
804068|NCT00988247|Secondary|Change From Baseline to Week 30 in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in Participants With Impaired Quality of Life at Baseline|"The adult RQLQ has 28 questions in 7 domains (activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional). Participants were asked to recall their experiences during the previous week and to give their responses on a 7-point scale (0 = Least severe to 6 = Extremely severe). The overall RQLQ score is the mean of all 28 responses, and ranges from 0 to 7.
Week 30 scores were compared to baseline scores. A negative change score indicates improvement."|Day 0 (Baseline) and Week 30|The RQLQ population included only those participants over the age of 18 years with an impaired quality of life at Baseline as defined by a RQLQ score at Day 0 of 3.0 or greater.||units on a scale||Standard Error|Least Squares Mean
804069|NCT00988247|Secondary|Change From Baseline in Average Subject-Assessed 24-Hour Instantaneous Total Nasal Symptom Score (iTNSS) up to 52 Weeks|"Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) in the past 10 minutes (prior to the assessment) daily using the following scale:
0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (bothersome but tolerable); 3=severe (hard to tolerate, interfere with daily activities).
The total nasal symptom score (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from baseline score indicates improvement."|Baseline (Days -6 to 0), Day 1 to Week 52|Intent to treat population||units on a scale||Standard Error|Least Squares Mean
804070|NCT00988247|Secondary|Change From Baseline in Average Subject-Assessed 24-Hour Reflective Total Nasal Symptom Score (rTNSS) up to 52 Weeks|"Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) in the past 24-hours (prior to the assessment) daily using the following scale:
0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (bothersome but tolerable); 3=severe (hard to tolerate, interfere with daily activities).
The total nasal symptom score (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from baseline score indicates improvement."|Baseline (Days -6 to 0), Day 1 to Week 52|Intent to treat population.||units on a scale||Standard Error|Least Squares Mean
804071|NCT00988247|Secondary|Change From Baseline in Average Subject-Assessed 24-Hour Instantaneous Total Nasal Symptom Score (iTNSS) up to 30 Weeks|"Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) in the past 10 minutes (prior to the assessment) daily using the following scale:
0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (bothersome but tolerable); 3=severe (hard to tolerate, interfere with daily activities).
The total nasal symptom score (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from baseline score indicates improvement."|Baseline (Days -6 to 0), Day 1 to Week 30|Intent to treat population||units on a scale||Standard Error|Least Squares Mean
804072|NCT00988247|Primary|Change From Baseline in Average Subject-Assessed 24-Hour Reflective Total Nasal Symptom Score (rTNSS) up to 30 Weeks|"Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) in the past 24-hours (prior to the assessment) daily using the following scale:
0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (bothersome but tolerable); 3=severe (hard to tolerate, interfere with daily activities).
The total nasal symptom score (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from baseline score indicates improvement."|Baseline (Days -6 to 0), Day 1 to Week 30|Intent to treat population||units on a scale||Standard Error|Least Squares Mean
804073|NCT00988325|Secondary|Number of Participants Showing Within-patient Variability in Vital Signs|Systolic blood pressure, diastolic blood pressure, pulse rate, respiratory rate, and heart rate were examined for any consistent within-patient post-baseline changes.|Post baseline, Day 3, 4, 6, 11, 18+/- 2 days, 30+/-2 days|Safety population included all treated participants with at least one post-baseline safety assessment. Due to the small numbers of participants and the extent of influenza induced variability, changes in vital sign patterns cannot be detected.|||||
804095|NCT00994240|Primary|Difference in Cure Rates of Superficial BCC Following One Cycle of ED&C Versus Three Cycles of ED&C.|Clinical evidence of BCC recurrence post treatment|base line, every 3 months until 12 month completion|Study was terminated early due to lack of funding and slow enrollment. Biostatisticians determined insufficient data was available for statistical significance. Primary/lead protocol author is no longer at the institution and no data analysis is intended. Study has been closed with the local IRB and study files archived.||participants|||Number
812474|NCT01070784|Primary|Clinical Laboratory Test: Haematology -Erythrocytes|Mean change from Baseline|Baseline and 52 week after|||*10000/μl||Standard Deviation|Mean
804074|NCT00988325|Secondary|Number of Participants With Adverse Events, Serious Adverse Events and Secondary Illness|An Adverse Event (AEs) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An Serious Adverse Event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect. Secondary illnesses were influenza disease-related events, namely bronchitis, pneumonia, otitis media, and sinusitis that resolved without sequelae. Adverse events, serious adverse events, and secondary illness are reported for on-treatment period (from the first dose of oseltamivir upto 3 days after the last dose of oseltamivir [Approximately 14 days].|Up to 3 days after the last dose of oseltamivir (Approximately 14 days)|Safety population included all treated participants with at least one post-baseline safety assessment||Participants|||Number
804075|NCT00988325|Secondary|Percentage of Participants With Decline of Body Temperature to the Afebrile State|This was performed for all participants who had fever at baseline Fever is defined as body temperature >37.0ºC. Rectal temperature is converted by subtracting 1 ºC. The rate of decline of body temperature was calculated as the slope of body temperature between the baseline temperature and the 1st temperature below 37°C. Participants with decline in body temperature were considered to have no fever; however, participants who did not show any decline in body temperature were considered to have persisting fever.|Baseline (Day 1), Day3/4, Day 6, Day 11, Day 18+/-2 days, Day 30+/-2 days|Pharmacodynamic Analysis Population consisted of all enrolled participants with a positive influenza infection confirmed by culture or PCR at baseline or anytime during the study||percentage of participants|||Number
804076|NCT00988325|Secondary|Time to Resolution of Fever in Participants With Fever at the Baseline|This was performed for all participants who had fever at baseline. Fever is defined as body temperature >37.0 degree Celsius. Rectal temperature is converted by subtracting 1 degree Celsius. Time to Resolution of Fever was defined as the time from the initiation of treatment to first time the afebrile state was reached and maintained for at least 21.5 hours, where afebrile state was defined as axillary temperature ≤ 37 degree Celsius.|Days 1 to 11; Day 18; Day 30|Pharmacodynamic Analysis Population consisted of all enrolled participants with a positive influenza infection confirmed by culture or PCR at baseline or anytime during the study||hours||Full Range|Median
804077|NCT00988325|Secondary|Number of Participants With Virus Shedding by Virus Type|The viral titer was measured by culture and reported in log10 (50% tissue culture infective dose [TCID50]). The viral load was analyzed by PCR and reported as log10 particles/mL. The number of patients positive for viral shedding by virus sub-type was measured on specified days from baseline to last visit on Day 30.|Baseline (Day 1), Day3/4, Day 6, Day 11, Day 18+/-2 days, Day 30+/-2 days|Pharmacodynamic Analysis Population consisted of all enrolled participants with a positive influenza infection confirmed by culture or PCR at baseline or anytime during the study||Participants|||Number
804078|NCT00988325|Secondary|Median Time to Cessation of Viral Shedding in Participants With Positive Culture at Baseline|Median time to cessation of viral shedding was calculated for all patients with positive by culture / by polymerase chain reaction (PCR) at baseline using all data points between the start of the treatment and the 1st time point of negative culture without subsequent positive culture results. These time-to event analyses were only performed for the viral titre.|Days 1, 3 or 4, 6, 11, 18, and 30|Pharmacodynamic Analysis Population consisted of all enrolled participants with a positive influenza infection confirmed by culture or PCR at baseline or anytime during the study||hours||95% Confidence Interval|Median
804079|NCT00988325|Secondary|Number of Participants With Change From Baseline in Neurological Assessment Scores|Neurological assessment was performed to assess the mental state of the participants through two scales: Infant face scale and Glasgow coma scale. Each scale consists of 3 subscales: eye opening (ranging 1 to 4), verbal response (ranging 1 to 5), and motor responses (ranging 1 to 6). The final score is the sum of these ranges and is scored between 3 and 15. 3 being the worst, and 15 the best. Change from baseline is change of final score post-baseline minus the final score at baseline.|Baseline (Day 1); Day 3 for who received two does on Day 1 or Day 4 for who received one dose on Day 1; Day 6, Day 11, Day 18, Day 30|Safety population included all treated participants with at least one post-baseline safety assessment||participants|||Number
804080|NCT00988325|Secondary|Time of the Last Measurable Plasma Concentration for Oseltamivir and Oseltamivir Carboxylate|Oseltamivir carboxylate is an active metabolite of oseltamivir.|15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 3 if two doses taken on Day 1 or 15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 4 if one dose taken on Day 1|Pharmacokinetic (PK) population included all treated participants with at least one blood sample evaluable for drug concentration level and who adhered to the protocol.||hours||Geometric Coefficient of Variation|Geometric Mean
804081|NCT00988325|Secondary|Clast of Oseltamivir and Oseltamivir Carboxylate|The last measurable plasma concentration of oseltamivir and oseltamivir carboxylate was the last quantifiable concentration of oseltamivir or oseltamivir carboxylate, respectively.|15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 3 if two doses taken on Day 1 or 15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 4 if one dose taken on Day 1|Pharmacokinetic (PK) population included all treated patients with at least one blood sample evaluable for drug concentration level and who were adhered to the protocol||ng/mL||Geometric Coefficient of Variation|Geometric Mean
804082|NCT00988325|Secondary|The Volume of Distribution as a Function of Bioavailability of Oseltamivir and Oseltamivir Carboxylate|Oseltamivir carboxylate is active metabolite of oseltamivir. V/F is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.|15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 3 if two doses taken on Day 1 or 15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 4 if one dose taken on Day 1|Pharmacokinetic (PK) population included all treated participants with at least one blood sample evaluable for drug concentration level and who adhered to the protocol. n = participants with evaluable drug concentration.||mL||Geometric Coefficient of Variation|Geometric Mean
804173|NCT00996892|Secondary|Tmax of Pictilisib on Cycle 1 Day 1 – Stage 1A All Cohorts||Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 15-17|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Median
804083|NCT00988325|Secondary|Total Plasma Clearance as a Function of Bioavailability and Apparent Plasma Clearance of the Metabolite as a Function of Bioavailability (CLm/F) of Oseltamivir and Oseltamivir Carboxylate|Oseltamivir carboxylate is active metabolite of oseltamivir. CL/F was calculated as dose/AUCinf, where AUCinf represents the area under the concentration-time curve of the analyte in plasma over the time interval from zero extrapolated to infinity|15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 3 if two doses taken on Day 1 or 15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 4 if one dose taken on Day 1|Pharmacokinetic (PK) population included all treated participants with at least one blood sample evaluable for drug concentration level and who adhered to the protocol. n = participants with evaluable drug concentration||mL/hour||Standard Deviation|Mean
804084|NCT00988325|Primary|Steady-state Minimum Observed Plasma Concentration of Oseltamivir and Oseltamivir Carboxylate|Oseltamivir carboxylate is active metabolite of oseltamivir. Cmin was estimated for both oseltamivir and oseltamivir carboxylate by non-compartmental analysis|15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 3 if two doses taken on Day 1 or 15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 4 if one dose taken on Day 1|Pharmacokinetic (PK) population included all treated participants with at least one blood sample evaluable for drug concentration level and who adhered to the protocol. n = participants with evaluable drug concentration.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
804085|NCT00988325|Primary|Steady-state Maximum Observed Plasma Concentration of Oseltamivir and Oseltamivir Carboxylate|Oseltamivir carboxylate is an active metabolite of oseltamivir. Cmax was estimated for both oseltamivir and Oseltamivir carboxylate by non-compartmental analysis.|15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 3 if two doses taken on Day 1 or 15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 4 if one dose taken on Day 1|Pharmacokinetic (PK) population included all treated participants with at least one blood sample evaluable for drug concentration level and who adhered to the protocol. n = participants with evaluable drug concentration||ng/mL||Geometric Coefficient of Variation|Geometric Mean
804086|NCT00988325|Secondary|Apparent First-order Elimination Rate Constant of Oseltamivir and Oseltamivir Carboxylate|Oseltamivir carboxylate is active metabolite of oseltamivir.The apparent first-order elimination rate constant (Lambda Z) was determined by linear regression analysis of terminal data points. A minimum of 3 data points were used for lambda Z estimation. By reporting tool convention, if n<3, no summary statistics were calculated|15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 3 if two doses taken on Day 1 or 15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 4 if one dose taken on Day 1|Pharmacokinetic (PK) population included all treated participants with at least one blood sample evaluable for drug concentration level and who adhered to the protocol.||1/hour||Geometric Coefficient of Variation|Geometric Mean
804087|NCT00988325|Secondary|Apparent Elimination Half Life of Oseltamivir and Oseltamivir Carboxylate|Elimination half-life is defined as the time required for elimination of a drug to half its plasma concentration and was computed using non-compartmental method|15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 3 if two doses taken on Day 1 or 15 minutes pre-dose; 1 hour +/-15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 4 if one dose taken on Day 1|Pharmacokinetic (PK) population included all treated participants with at least one blood sample evaluable for drug concentration level and who adhered to the protocol. n = participants with evaluable drug concentration||hours||Geometric Coefficient of Variation|Geometric Mean
804088|NCT00988325|Secondary|Time to the Maximum Observed Plasma Concentration of Oseltamivir and Oseltamivir Carboxylate|Oseltamivir carboxylate is an active metabolite of oseltamivir.Tmax was estimated using non-compartmental methods|15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 3 if two doses taken on Day 1 or 15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 4 if one dose taken on Day 1|Pharmacokinetic (PK) population included all treated participants with at least one blood sample evaluable for drug concentration level and who adhered to the protocol. n = participants with evaluable drug concentration||hours||Full Range|Median
804089|NCT00988325|Primary|Steady-state Area Under the Plasma Concentration Versus Time Curve From Time Zero to 12 Hours of Oseltamivir and Oseltamivir Carboxylate|Oseltamivir carboxylate is active metabolite of oseltamivir. AUC0-12 was estimated for oseltamivir and oseltamivir carboxylate by linear trapezoidal rule|15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 3 if two doses taken on Day 1 or 15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 4 if one dose taken on Day 1|Pharmacokinetic (PK) population included all treated participants with at least one blood sample evaluable for drug concentration level and who adhered to the protocol. n = participants with evaluable drug concentration||hour (h)*nanogram(ng)/milliliter (mL)||Geometric Coefficient of Variation|Geometric Mean
804090|NCT00988351|Secondary|Treatment Pressure (Level of CPAP or 90th Percentile APAP)|The level of CPAP used for treatment versus the 90th percentile pressure used during APAP. The 90th percentile pressure is the value that is used if one converts a patient from APAP to CPAP.|6 weeks clinic|participants using PAP at the 6 weeks clinic visit||cm H2O||Standard Deviation|Mean
804091|NCT00988351|Secondary|Residual Apnea-hypopnea Index|The PAP device estimate of residual apnea-hypopnea index (AHI, number of apneas and hypopneas per hour of patient use) an estimate of effectiveness of treatment. An AHI < 10 is considered adequate treatment and <5/hour ideal treatment.|over first 6 weeks of treatment|participants using PAP at clinic visit (>= 1/2 hour of nightly use)||events (apneas+hypopneas)/hour||Standard Deviation|Mean
804092|NCT00988351|Secondary|Change in Functional Outcomes of Sleep Questionnaire|The functional outcomes of sleep questionnaire (FOSQ) is a standard quality of life measure used to assess improvement in quality of life after treatment for sleep disorders. The total FOSQ score was analyzed. The range if 5 to 20. A higher score is a better quality of life. This analysis compares the change after treatment (post treatment FOSQ - pretreatment FOSQ). A positive difference indicates an improve in the quality of life.|6 weeks at clinic|Using PAP 1/2 hour or more nightly||units on a scale||Standard Deviation|Mean
804093|NCT00988351|Secondary|Change in Epworth Sleepiness Scale|Epworth sleepiness scale (ESS) is measure of subjective sleepiness. Tendency to fall asleep in 8 situations. Total varies from zero to 24. A ESS of 10 or less is considered normal. The change in the ESS = post-treatment value - pre-treatment value. A decrease in the ESS (negative change) is consistent with less sleepiness.|6 weeks after starting treatment|||units on a scale||Standard Deviation|Mean
804098|NCT00994318|Primary|Kaplan-Meier Survival Analysis for Time to Other Anemia Therapy or Hb Trigger|"Endpoint reported number of participants with/without events and was reached:
First time of initiation of additional or alternative anaemia management,
First time the subject reached the Hb trigger.
3 primary comparisons using a hierarchical step-down procedure on the log-rank test to preserve an alpha level of 0.05, performed in the following order:
FCM (high ferritin target) compared with oral iron.
FCM (high ferritin target) compared with FCM (low ferritin target).
FCM (low ferritin target) compared with oral iron.
Sensitivity analyses of the primary endpoint were performed using the following alternative definitions of time to initiation of additional or alternative anaemia management:
Without taking into account the Hb trigger.
Taking into account the Hb trigger based on local laboratory data, instead of central laboratory data.
Taking into account the Hb trigger based on subjects with a complete set of Hb values from the central laboratory."|Up to 1 year after baseline|The Full Analysis Set (FAS) was used for the primary endpoint analysis, which consisted of all subjects randomised to treatment, received at least 1 dose of study treatment or, according to the protocol, were not treated due to ferritin value <100 mcg/L, and attended at least 1 post-baseline visit with at least 1 non-missing assessment available.||participants|||Number
804099|NCT00994422|Primary|Summary of the Reported Skin/Scalp Irritations Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)|"Participants skin/scalp irritations were assessed before treatment (Day 1) and Post-treatment with either Ivermectin or placebo by a trained evaluator.
Severe scalp irritations were defined as follows:
Severe Pruritus - Nearly constant, frequent scratching, very bothersome; Severe Erythema - Large areas of the scalp are red; Severe Excoriation: Widespread breaking of the skin involving most of the scalp; Severe Pyoderma - Lesions with crusting or other evidence of infection, involving most of the scalp."|Day 1 up to Day 15 post-application|Local tolerability was assessed in the Intent-to-treat (Safety) population.||Participants|||Number
804100|NCT00994422|Primary|Number of Participants Reporting Adverse Events Post-Treatment With Either Ivermectin or Placebo (Vehicle Control)||Day 1 up to Day 28 post-application|Adverse events were assessed in the Intent-to-treat (Safety) population.||Participants|||Number
804101|NCT00994422|Primary|Percentage of Participants With Treatment Success Following Treatment With Either Ivermectin or Placebo (Vehicle Control)|Treatment success was defined as the absence of live lice and was determined by visual examination of hair and scalp by a trained evaluator.|Days 2 up to Day 15 post-treatment|Treatment success was assessed in the Intent-to-treat population. Any participant with live lice on or after Day 2 received an FDA approved head lice treatment and was classified as a treatment failure, imputed as such for remaining assessments.||Percent of Participants|||Number
804102|NCT00994448|Primary|Feasibility of Retaining Adolescents in Trial|the mean retention for participants is used to assess feasibility of retaining adolescents in the trial (completion = 56 days or 8 weeks)|8 weeks|mean days retained in treatment for each grou[p||days||Standard Deviation|Mean
804103|NCT00994461|Secondary|Incidence of Treatment-emergent, All-causality GI Body System Adverse Events|The percentage of subjects who had treatment-emergent, all-causality gastrointestinal body system adverse events after 2 weeks treatment (The number of subjects who had treatment-emergent, all-causality gastrointestinal body system adverse events after 2 weeks treatment divided by participants multiplied by 100.)|2 weeks|The m-SAF consisted of all randomized subjects who received at least one dose of the study drug, and underwent endoscopy at baseline and at the end/discontinuation of treatment, as well.||Percent|||Number
804104|NCT00994461|Secondary|Number of Gastroduodenal Erosions in Each Subject|Number of subjects for each number of gastroduodenal endoscopic erosions after 2 weeks treatment (An erosion is defined as a lesion producing a definite break in the mucosa with equivocal depth.)|2 weeks|The m-SAF consisted of all randomized subjects who received at least one dose of the study drug, and underwent endoscopy at baseline and at the end/discontinuation of treatment, as well.||Participants|||Number
804105|NCT00994461|Secondary|Number of Gastroduodenal Ulcers in Each Subject|Number of subjects for each number of gastroduodenal endoscopic ulcers after 2 weeks treatment (An ulcer is defined as any break in the mucosa at least 3 mm in diameter with unequivocal depth.)|2 weeks|The m-SAF consisted of all randomized subjects who received at least one dose of the study drug, and underwent endoscopy at baseline and at the end/discontinuation of treatment, as well.||Participants|||Number
804106|NCT00994461|Secondary|Post-treatment Gastroduodenal Endoscopic Scores (According to Mucosal Grading Scale)|Number of subjects for each gastroduodenal endoscopic score (according to Mucosal Grading Scale) after 2 weeks treatment (Score 0 = normal mucosa (no visible lesions); Score 1 = 1 to 10 petechiae; Score 2 = more than 10 petechiae; Score 3 = 1 to 5 erosions; Score 4 = 6 to 10 erosions; Score 5 = 11 to 25 erosions; Score 6 = more than 25 erosions; Score 7 = ulcer)|2 weeks|The m-SAF consisted of all randomized subjects who received at least one dose of the study drug, and underwent endoscopy at baseline and at the end/discontinuation of treatment, as well.||Participants|||Number
804107|NCT00994461|Secondary|Incidence of Any Gastroduodenal, Gastric, and Duodenal Ulcers and/or Erosions|The percentage of subjects who had gastroduodenal, gastric, and duodenal endoscopic ulcers and/or erosions after 2 weeks treatment (The number of subjects who had gastroduodenal, gastric, and duodenal endoscopic ulcers and/or erosions after 2 weeks treatment divided by participants multiplied by 100.) An ulcer is defined as any break in the mucosa at least 3 mm in diameter with unequivocal depth. An erosion is defined as a lesion producing a definite break in the mucosa with equivocal depth.|2 weeks|The m-SAF consisted of all randomized subjects who received at least one dose of the study drug, and underwent endoscopy at baseline and at the end/discontinuation of treatment, as well.||Percent|||Number
804108|NCT00994461|Secondary|Incidence of Any Gastric, and Duodenal Ulcers|The percentage of subjects who had gastric and duodenal endoscopic ulcers after 2 weeks treatment (The number of subjects who had gastric and duodenal endoscopic ulcers after 2 weeks treatment divided by participants multiplied by 100.) An ulcer is defined as any break in the mucosa at least 3 mm in diameter with unequivocal depth.|2 weeks|The m-SAF consisted of all randomized subjects who received at least one dose of the study drug, and underwent endoscopy at baseline and at the end/discontinuation of treatment, as well.||Percent|||Number
804149|NCT00996892|Secondary|Accumulation Ratio of Pictilisib on Cycle 1 Day 21 – Stage 1B All Cohorts|Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 21 divided by AUC0-24 at Cycle 1 Day 1.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Days 1 and 21, Cycle 1 Days 2 and 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ratio||Geometric Coefficient of Variation|Geometric Mean
804109|NCT00994461|Primary|Incidence of Gastroduodenal Ulcers|The percentage of subjects who had gastroduodenal endoscopic ulcers after 2 weeks treatment (The number of subjects who had gastroduodenal endoscopic ulcers after 2 weeks treatment divided by participants multiplied by 100.) An ulcer is defined as any break in the mucosa at least 3 mm in diameter with unequivocal depth.|2 weeks|The modified-safety analysis set (m-SAF) consisted of all randomized subjects who received at least one dose of the study drug, and underwent endoscopy at baseline and at the end/discontinuation of treatment, as well.||Percent|||Number
804110|NCT00996892|Secondary|Progression-Free Survival (PFS) - Dose Escalation Stages 1, 1A and 1B|PFS was the time from study treatment initiation to the first occurrence of disease progression, as determined by investigator review of tumor assessments using RECIST, or death from any cause during the study (within 30 days after the last dose of study treatment). PD = at least 20% increase in the sum of the longest diameter of measured lesions taking as reference the smallest sum of the longest diameter since treatment start or appearance of one or more new lesions.|Up to 30 days after last dose (last dose = up to Cycle 15, cycle length = 28 days)|Data for this outcome measure was not collected as per changes in planned analysis.|||||
804111|NCT00996892|Secondary|Duration of Objective Response - Dose Escalation Stages 1, 1A and 1B|Duration of objective response was defined as the time from first occurrence of a documented objective response (CR or PR) until the time of disease progression, as determined by investigator review of tumor assessments using RECIST, or death from any cause during the study (within 30 days after the last dose of study treatment). CR = disappearance of all target and non-target lesions. PR = at least 30 % decrease in sum of the longest diameter of measured lesions taking as reference the baseline sum of the longest diameter. PD = at least 20% increase in the sum of the longest diameter of measured lesions taking as reference the smallest sum of the longest diameter since treatment start or appearance of one or more new lesions.|Up to 30 days after last dose (last dose = up to Cycle 15, cycle length = 28 days)|Data for this outcome measure was not collected as per changes in planned analysis.|||||
804112|NCT00996892|Secondary|Number of Participants With Best Overall Response - Dose Escalation Stages 1, 1A and 1B|Tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) = disappearance of all target and non-target lesions. Partial Response (PR) = at least 30 percent (%) decrease in sum of the longest diameter of measured lesions taking as reference the baseline sum of the longest diameter. Progressive disease (PD) = at least 20% increase in the sum of the longest diameter of measured lesions taking as reference the smallest sum of the longest diameter since treatment start or appearance of one or more new lesions. Stable disease (SD) = neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of the longest diameter since treatment start.|Up to 30 days after last dose (last dose = up to Cycle 15, cycle length = 28 days)|Safety-evaluable population. Here, number of participants analyzed = participants who were evaluable for this outcome.||participants|||Number
804113|NCT00996892|Secondary|Accumulation Ratio of Pictilisib on Cycle 1 Day 18 – Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately. Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 21 divided by AUC0-24 at Cycle 1 Day 1. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
804114|NCT00996892|Secondary|CL/F of Pictilisib on Cycle 1 Day 18 – Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately. Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||L/hr||Geometric Coefficient of Variation|Geometric Mean
804115|NCT00996892|Secondary|t1/2 of Pictilisib on Cycle 1 Day 18 – Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately. Half-life is the time measured for the plasma concentration to decrease by one half.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Geometric Mean
804116|NCT00996892|Secondary|AUC0-24 of Pictilisib on Cycle 1 Day 18 – Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
804117|NCT00996892|Secondary|Cmax of Pictilisib on Cycle 1 Day 18 – Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
804131|NCT00996892|Secondary|Accumulation Ratio of Pictilisib on Cycle 1 Day 21 – Stage 2 Individual Indication Specific Cohorts|Stage 2 PK data were reported for each indication specific cohort separately. Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 21 divided by AUC0-24 at Cycle 1 Day 1.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Days 1 and 21, Cycle 1 Days 2 and 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ratio||Geometric Coefficient of Variation|Geometric Mean
804118|NCT00996892|Secondary|Tmax of Pictilisib on Cycle 1 Day 18 – Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Median
804119|NCT00996892|Secondary|AUC0-24 of Pictilisib on Cycle 1 Day 1 – Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Days 2|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
804120|NCT00996892|Secondary|Cmax of Pictilisib on Cycle 1 Day 1 – Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 15-17|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
804121|NCT00996892|Secondary|Tmax of Pictilisib on Cycle 1 Day 1 – Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 15-17|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Median
804122|NCT00996892|Secondary|Accumulation Ratio of Cobimetinib on Cycle 1 Day 18 – Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately. Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 21 divided by AUC0-24 at Cycle 1 Day 1. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
804123|NCT00996892|Secondary|CL/F of Cobimetinib on Cycle 1 Day 18 – Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately. Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||L/hr||Geometric Coefficient of Variation|Geometric Mean
804124|NCT00996892|Secondary|t1/2 of Cobimetinib on Cycle 1 Day 18 – Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately. Half-life is the time measured for the plasma concentration to decrease by one half. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Geometric Mean
804125|NCT00996892|Secondary|AUC0-24 of Cobimetinib on Cycle 1 Day 18 – Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
804126|NCT00996892|Secondary|Cmax of Cobimetinib on Cycle 1 Day 18 – Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
804127|NCT00996892|Secondary|Tmax of Cobimetinib on Cycle 1 Day 18 – Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as median.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Median
804128|NCT00996892|Secondary|AUC0-24 of Cobimetinib on Cycle 1 Day 1 – Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Days 2|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
804129|NCT00996892|Secondary|Cmax of Cobimetinib on Cycle 1 Day 1 – Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 15-17|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
804309|NCT00997438|Primary|cAMP Levels||4 hours|Useable PBMCs were not obtained from one healthy control and 2 relapsing remitting MS patients||pmol cAMP/mg protein||Inter-Quartile Range|Median
804132|NCT00996892|Secondary|CL/F of Pictilisib on Cycle 1 Day 21 – Stage 2 Individual Indication Specific Cohorts|Stage 2 PK data were reported for each indication specific cohort separately. Half-life is the time measured for the plasma concentration to decrease by one half. Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||L/hr||Geometric Coefficient of Variation|Geometric Mean
804133|NCT00996892|Secondary|t1/2 of Pictilisib on Cycle 1 Day 21 – Stage 2 Individual Indication Specific Cohorts|Stage 2 PK data were reported for each indication specific cohort separately. Half-life is the time measured for the plasma concentration to decrease by one half.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Geometric Mean
804134|NCT00996892|Secondary|AUC0-24 of Pictilisib on Cycle 1 Day 21 – Stage 2 Individual Indication Specific Cohorts|Stage 2 PK data were reported for each indication specific cohort separately.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
804135|NCT00996892|Secondary|Cmax of Pictilisib on Cycle 1 Day 21 – Stage 2 Individual Indication Specific Cohorts|Stage 2 PK data were reported for each indication specific cohort separately.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
804136|NCT00996892|Secondary|Tmax of Pictilisib on Cycle 1 Day 21 – Stage 2 Individual Indication Specific Cohorts|Stage 2 PK data were reported for each indication specific cohort separately.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Median
804137|NCT00996892|Secondary|AUC0-24 of Pictilisib on Cycle 1 Day 1 – Stage 2 Individual Indication Specific Cohorts|Stage 2 PK data were reported for each indication specific cohort separately.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Days 2|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
804138|NCT00996892|Secondary|Cmax of Pictilisib on Cycle 1 Day 1 – Stage 2 Individual Indication Specific Cohorts|Stage 2 PK data were reported for each indication specific cohort separately.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 14|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
804139|NCT00996892|Secondary|Tmax of Pictilisib on Cycle 1 Day 1 – Stage 2 Individual Indication Specific Cohorts|Stage 2 PK data were reported for each indication specific cohort separately.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 14|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Median
804140|NCT00996892|Secondary|Accumulation Ratio of Cobimetinib on Cycle 1 Day 21 – Stage 2 Individual Indication Specific Cohorts|Stage 2 PK data were reported for each indication specific cohort separately. Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 21 divided by AUC0-24 at Cycle 1 Day 1.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Days 1 and 21, Cycle 1 Days 2 and 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ratio||Geometric Coefficient of Variation|Geometric Mean
804141|NCT00996892|Secondary|CL/F of Cobimetinib on Cycle 1 Day 21 – Stage 2 Individual Indication Specific Cohorts|Stage 2 PK data were reported for each indication specific cohort separately. Half-life is the time measured for the plasma concentration to decrease by one half. Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||L/hr||Geometric Coefficient of Variation|Geometric Mean
804142|NCT00996892|Secondary|t1/2 of Cobimetinib on Cycle 1 Day 21 – Stage 2 Individual Indication Specific Cohorts|Stage 2 PK data were reported for each indication specific cohort separately. Half-life is the time measured for the plasma concentration to decrease by one half.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Geometric Mean
804143|NCT00996892|Secondary|AUC0-24 of Cobimetinib on Cycle 1 Day 21 – Stage 2 Individual Indication Specific Cohorts|Stage 2 PK data were reported for each indication specific cohort separately.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
804144|NCT00996892|Secondary|Cmax of Cobimetinib on Cycle 1 Day 21 – Stage 2 Individual Indication Specific Cohorts|Stage 2 PK data were reported for each indication specific cohort separately.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
804145|NCT00996892|Secondary|Tmax of Cobimetinib on Cycle 1 Day 21 – Stage 2 Individual Indication Specific Cohorts|Stage 2 PK data were reported for each indication specific cohort separately.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Median
804146|NCT00996892|Secondary|AUC0-24 of Cobimetinib on Cycle 1 Day 1 – Stage 2 All Cohorts|Stage 2 PK data were reported for each indication specific cohort separately.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Days 2|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
804150|NCT00996892|Secondary|CL/F of Pictilisib on Cycle 1 Day 21 – Stage 1B All Cohorts|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||L/hr||Geometric Coefficient of Variation|Geometric Mean
804151|NCT00996892|Secondary|AUC0-24 of Pictilisib on Cycle 1 Day 21 – Stage 1B All Cohorts||Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
804152|NCT00996892|Secondary|Cmax of Pictilisib on Cycle 1 Day 21 – Stage 1B All Cohorts||Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
804153|NCT00996892|Secondary|Tmax of Pictilisib on Cycle 1 Day 21 – Stage 1B All Cohorts||Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Median
804154|NCT00996892|Secondary|AUC0-24 of Pictilisib on Cycle 1 Day 1 – Stage 1B All Cohorts||Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Day 2|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
804155|NCT00996892|Secondary|Cmax of Pictilisib on Cycle 1 Day 1 – Stage 1B All Cohorts||Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Day 2|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
804156|NCT00996892|Secondary|Tmax of Pictilisib on Cycle 1 Day 1 – Stage 1B All Cohorts||Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Day 2|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Median
804157|NCT00996892|Secondary|Accumulation Ratio of Cobimetinib on Cycle 1 Day 21 – Stage 1B All Cohorts|Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 21 divided by AUC0-24 at Cycle 1 Day 1.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Days 1 and 21, Cycle 1 Days 2 and 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ratio||Geometric Coefficient of Variation|Geometric Mean
804158|NCT00996892|Secondary|CL/F of Cobimetinib on Cycle 1 Day 21 – Stage 1B All Cohorts|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||L/hr||Geometric Coefficient of Variation|Geometric Mean
804159|NCT00996892|Secondary|AUC0-24 of Cobimetinib on Cycle 1 Day 21 – Stage 1B All Cohorts||Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
804160|NCT00996892|Secondary|Cmax of Cobimetinib on Cycle 1 Day 21 – Stage 1B All Cohorts||Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
804161|NCT00996892|Secondary|Tmax of Cobimetinib on Cycle 1 Day 21 – Stage 1B All Cohorts||Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Median
804162|NCT00996892|Secondary|AUC0-24 of Cobimetinib on Cycle 1 Day 1 – Stage 1B All Cohorts||Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Day 2|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
804163|NCT00996892|Secondary|Cmax of Cobimetinib on Cycle 1 Day 1 – Stage 1B All Cohorts||Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Day 2|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
804164|NCT00996892|Secondary|Tmax of Cobimetinib on Cycle 1 Day 1 – Stage 1B All Cohorts||Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Day 2|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Median
804165|NCT00996892|Secondary|Accumulation Ratio of Pictilisib on Cycle 1 Day 18 – Stage 1A All Cohorts|Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 18 divided by AUC0-24 at Cycle 1 Day 1.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Days 1 and 18, Cycle 1 Days 2, 19|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ratio||Geometric Coefficient of Variation|Geometric Mean
804166|NCT00996892|Secondary|CL/F of Pictilisib on Cycle 1 Day 18 – Stage 1A All Cohorts|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||L/hr||Geometric Coefficient of Variation|Geometric Mean
804167|NCT00996892|Secondary|t1/2 of Pictilisib on Cycle 1 Day 18 – Stage 1A All Cohorts|Half-life is the time measured for the plasma concentration to decrease by one half. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Geometric Mean
804310|NCT00997438|Primary|cAMP Levels||2 hours|Useable PBMCs were not obtained from one healthy control and 2 relapsing remitting MS patients||pmol cAMP/mg protein||Inter-Quartile Range|Median
804174|NCT00996892|Secondary|Accumulation Ratio of Cobimetinib on Cycle 1 Day 18 – Stage 1A All Cohorts|Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 18 divided by AUC0-24 at Cycle 1 Day 1.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Days 1 and 18, Cycle 1 Days 2, 19|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ratio||Geometric Coefficient of Variation|Geometric Mean
804175|NCT00996892|Secondary|CL/F of Cobimetinib on Cycle 1 Day 18 – Stage 1A All Cohorts|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||L/hr||Geometric Coefficient of Variation|Geometric Mean
804176|NCT00996892|Secondary|t1/2 of Cobimetinib on Cycle 1 Day 18 – Stage 1A All Cohorts|Half-life is the time measured for the plasma concentration to decrease by one half.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Geometric Mean
804177|NCT00996892|Secondary|AUC0-24 of Cobimetinib on Cycle 1 Day 18 – Stage 1A All Cohorts||Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
804178|NCT00996892|Secondary|Cmax of Cobimetinib on Cycle 1 Day 18 – Stage 1A All Cohorts||Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
804179|NCT00996892|Secondary|Tmax of Cobimetinib on Cycle 1 Day 18 – Stage 1A All Cohorts||Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Median
804180|NCT00996892|Secondary|AUC0-24 of Cobimetinib on Cycle 1 Day 1 – Stage 1A All Cohorts||Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Days 2|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
804181|NCT00996892|Secondary|Cmax of Cobimetinib on Cycle 1 Day 1 – Stage 1A All Cohorts||Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 15-17|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
804182|NCT00996892|Secondary|Tmax of Cobimetinib on Cycle 1 Day 1 – Stage 1A All Cohorts||Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 15-17|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Median
804183|NCT00996892|Secondary|Accumulation Ratio of Pictilisib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) – Stage 1 All Cohorts|Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) divided by AUC0-24 at Cycle 1 Day 1 (Cycle 1 Day 8 for Cohorts 1-3).|Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Days 8 and 28, Cycle 1 Days 9, 29; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Days 1 and 21, Cycle 1 Day 2, 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ratio||Geometric Coefficient of Variation|Geometric Mean
804184|NCT00996892|Secondary|CL/F of Pictilisib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) – Stage 1 All Cohorts|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 28, Cycle 1 Day 29, Cycle 2 Days 1, 15, 21; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||L/hr||Geometric Coefficient of Variation|Geometric Mean
804185|NCT00996892|Secondary|t1/2 of Pictilisib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) – Stage 1 All Cohorts|Half-life is the time measured for the plasma concentration to decrease by one half. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.|Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 28, Cycle 1 Day 29, Cycle 2 Days 1, 15, 21; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Geometric Mean
804186|NCT00996892|Secondary|AUC0-24 of Pictilisib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) – Stage 1 All Cohorts||Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 28, Cycle 1 Day 29; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
804187|NCT00996892|Secondary|Cmax of Pictilisib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) – Stage 1 All Cohorts||Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 28, Cycle 1 Day 29, Cycle 2 Days 1, 15, 21; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
804188|NCT00996892|Secondary|Tmax of Pictilisib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) – Stage 1 All Cohorts||Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 28, Cycle 1 Day 29, Cycle 2 Days 1, 15, 21; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Median
804311|NCT00997438|Primary|Lipoic Acid Levels|Plasma concentration of LA|48 hour|Plasma samples from one secondary progressive and one healthy control subject did not yield results for unknown reason(s).||ng/mL||Standard Error|Mean
804189|NCT00996892|Secondary|AUC0-24 of Pictilisib on Cycle 1 Day 1 (Cycle 1 Day 8 for Cohorts 1-3) – Stage 1 All Cohorts||Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 8, Cycle 1 Day 9; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Day 2|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
804190|NCT00996892|Secondary|Cmax of Pictilisib on Cycle 1 Day 1 (Cycle 1 Day 8 for Cohorts 1-3) – Stage 1 All Cohorts||Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 8, Cycle 1 Day 9, 15, 21; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Day 2, 8, 14|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
804191|NCT00996892|Secondary|Tmax of Pictilisib on Cycle 1 Day 1 (Cycle 1 Day 8 for Cohorts 1-3) – Stage 1 All Cohorts||Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 8, Cycle 1 Day 9, 15, 21; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Day 2, 8, 14|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Median
804192|NCT00996892|Secondary|Accumulation Ratio of Cobimetinib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) – Stage 1 All Cohorts|Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) divided by AUC0-24 at Cycle 1 Day 1 (Cycle 1 Day 8 for Cohorts 1-3).|Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Days 8 and 28, Cycle 1 Days 9, 29; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Days 1 and 21, Cycle 1 Days 2, 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ratio||Geometric Coefficient of Variation|Geometric Mean
804193|NCT00996892|Secondary|Apparent Clearance (CL/F) of Cobimetinib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) – Stage 1 All Cohorts|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 28, Cycle 1 Day 29, Cycle 2 Days 1, 15, 21; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||Liters per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
804194|NCT00996892|Secondary|Terminal Half-life (t1/2) of Cobimetinib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) – Stage 1 All Cohorts|Half-life is the time measured for the plasma concentration to decrease by one half.|Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 28, Cycle 1 Day 29, Cycle 2 Days 1, 15, 21; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Geometric Mean
804195|NCT00996892|Secondary|AUC0-24 of Cobimetinib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) – Stage 1 All Cohorts||Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 28, Cycle 1 Day 29; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
804196|NCT00996892|Secondary|Cmax of Cobimetinib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) – Stage 1 All Cohorts||Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 28, Cycle 1 Day 29, Cycle 2 Days 1, 15, 21; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
804197|NCT00996892|Secondary|Tmax of Cobimetinib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) – Stage 1 All Cohorts||Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 28, Cycle 1 Day 29, Cycle 2 Days 1, 15, 21; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Median
804198|NCT00996892|Secondary|AUC0-24 of Cobimetinib on Cycle 1 Day 1 (Cycle 1 Day 8 for Cohorts 1-3) – Stage 1 All Cohorts||Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 8, Cycle 1 Days 9; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Day 2|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
804199|NCT00996892|Secondary|Cmax of Cobimetinib on Cycle 1 Day 1 (Cycle 1 Day 8 for Cohorts 1-3) – Stage 1 All Cohorts||Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 8, Cycle 1 Days 9, 15, 21; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Day 2, 8, 14|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
804200|NCT00996892|Secondary|Tmax of Cobimetinib on Cycle 1 Day 1 (Cycle 1 Day 8 for Cohorts 1-3) – Stage 1 All Cohorts||Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 8, Cycle 1 Days 9, 15, 21; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Day 2, 8, 14|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Median
804201|NCT00996892|Primary|AUC0-24 of Pictilisib on Day 1 – Stage 1, Cohorts 1-3||0-4 hours Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Day 1, Day 2, 0-4 hours Pr-C dose on Day 3|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
804202|NCT00996892|Primary|Cmax of Pictilisib on Day 1 – Stage 1, Cohorts 1-3||0-4 hours Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Day 1, Day 2, 0-4 hours Pr-C dose on Day 3|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
804203|NCT00996892|Primary|Tmax of Pictilisib on Day 1 – Stage 1, Cohorts 1-3||0-4 hours pre-pictilisib (Pr-P) dose, 0.5, 2, 4, 6 hours post-pictilisib (Po-P) dose on Day 1, Day 2, 0-4 hours Pr-C dose on Day 3|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Median
804312|NCT00997438|Primary|Lipoic Acid Levels|Plasma concentration of LA|24 hour|Plasma samples from one secondary progressive and one healthy control subject did not yield results for unknown reason(s).||ng/mL||Standard Error|Mean
804204|NCT00996892|Primary|Area Under the Concentration-Time Curve From Time 0 to 24 Hours Post-Dose (AUC0-24) of Cobimetinib on Day 3 – Stage 1, Cohorts 1-3||0-4 hours Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Day 3, Day 4|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||nonograms*hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
804205|NCT00996892|Primary|Maximum Plasma Concentration (Cmax) of Cobimetinib on Day 3 – Stage 1, Cohorts 1-3||0-4 hours Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Day 3, Day 4|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
804206|NCT00996892|Primary|Time of Maximum Concentration (Tmax) of Cobimetinib on Day 3 – Stage 1, Cohorts 1-3||0-4 hours pre-cobimetinib (Pr-C) dose, 0.5, 2, 4, 6 hours post-cobimetinib (Po-C) dose on Day 3, Day 4|Pharmacokinetic (PK) population included all participants who had at least one cobimetinib and pictilisib plasma concentration available. Here, number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Median
804207|NCT00996892|Primary|Maximum Tolerated Combination Doses of Cobimetinib and Pictilisib During Dose-Escalation Stages 1, 1A and 1B|MTD was determined (by Investigator) based on the DLTs, as well as adverse events (AEs) in dose-escalation Stages 1, 1A, and 1B that did not meet protocol-defined DLT criteria but indicated intolerability of a given dose combination. Separate combination MTDs were determined for each dose-escalation stage. DLT was defined as 1 of the following toxicities considered treatment related by Investigator: Grade ≥3 non-hematologic, non–hepatic organ toxicity; Grade ≥3 febrile neutropenia; Grade ≥4 neutropenia (absolute neutrophil count <500/microliter) lasting >5 days; Grade ≥4 thrombocytopenia lasting >48 hours; Grade ≥4 anemia; Grade ≥3 total bilirubin, hepatic transaminase, alkaline phosphatase, lasting >72 hours; Grade ≥2 diffusion capacity of the lung for carbon monoxide concomitant with an absolute decrease of ≥20 percentage points from baseline.|Cohorts 1-3: Day 1 to Day 35, All other cohorts: Day 1 to Day 28|Safety-evaluable population. Here, number of participants analyzed = participants who were evaluable for this outcome and n = participants evaluable for specified categories.||mg|||Number
804208|NCT00996892|Primary|Number of Participants With Dose-Limiting Toxicities (DLTs) During Dose Escalation Stages 1, 1A and 1B|DLT was defined as 1 of the following toxicities considered treatment related by Investigator: Grade ≥3 non-hematologic, non–hepatic organ toxicity, excluding the following: Grade 3 nausea, vomiting, or diarrhea that resolved to Grade ≤1 within 7 days, Grade 3 rash or Grade ≥3 fatigue that resolved to Grade ≤2 within 7 days, Grade ≥3 hyperglycemia or lipid profile results that occurred during non-fasting conditions, Grade 3 or 4 elevation of serum creatine phosphokinase levels or Grade 3 non clinically significant (as assessed by Investigator) laboratory abnormality that was asymptomatic; Grade ≥3 febrile neutropenia; Grade ≥4 neutropenia (absolute neutrophil count <500/microliter) lasting >5 days; Grade ≥4 thrombocytopenia lasting >48 hours; Grade ≥4 anemia; Grade ≥3 total bilirubin, hepatic transaminase, alkaline phosphatase, lasting >72 hours; Grade ≥2 diffusion capacity of the lung for carbon monoxide concomitant with an absolute decrease of ≥20 percentage points from baseline.|Cohorts 1-3: Day 1 to Day 35, All other cohorts: Day 1 to Day 28|Safety-evaluable population included all participants who received at least one dose of study drug. Here, number of participants analyzed = participants who were evaluable for this outcome.||participants|||Number
804209|NCT00996918|Secondary|Change From Extension Study Baseline in MMSE Score at Weeks 6, 19, 32, 45 and 78.|MMSE measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. Total score derived from sub-scores; total ranged from 0 to 30, higher score indicates better cognitive state|Weeks 6, 19, 32, 45 and 78|||Units on a scale||Standard Error|Least Squares Mean
804210|NCT00996918|Secondary|Change From Base Study Baseline in Mini-mental State Examination (MMSE) Score at Weeks 6, 19, 32, 45 and 78.|MMSE measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. Total score derived from sub-scores; total ranged from 0 to 30, higher score indicates better cognitive state.|Weeks 6, 19, 32, 45 and 78|The Extension mITT Population was defined as all randomly assigned participants who received at least one dose of investigational product in the extension study and who had a baseline for the extension study and at least one valid post-baseline assessment of the ADAS-Cog total score and DAD total score in the extension study.||Units on a scale||Standard Error|Least Squares Mean
804211|NCT00996918|Secondary|Change From Extension Study Baseline in NPI Score at Weeks 26, 52 and 78.|NPI:12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, night-time behavior. Severity (1=Mild to 3=Severe), frequency (1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score(range 0-12). Total score=sum of each domain score(range 0-144); higher score=greater behavioral disturbances; negative change score from baseline=improvement.|Weeks 26, 52 and 78|The Extension mITT Population was defined as all randomly assigned participants who received at least one dose of investigational product in the extension study and who had a baseline for the extension study and at least one valid post-baseline assessment of the ADAS-Cog total score and DAD total score in the extension study.||Units on a scale||Standard Error|Least Squares Mean
804212|NCT00996918|Secondary|Change From Base Study Baseline in Neuropsychiatric Inventory (NPI) Score at Weeks 26, 52 and 78.|NPI:12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, nighttime behavior. Severity (1=Mild to 3=Severe), frequency (1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score(range 0-12). Total score=sum of each domain score (range 0-144); higher score=greater behavioral disturbances; negative change score from baseline=improvement.|Weeks 26, 52 and 78|The Extension mITT Population was defined as all randomly assigned participants who received at least one dose of investigational product in the extension study and who had a baseline for the extension study and at least one valid post-baseline assessment of the ADAS-Cog total score and DAD total score in the extension study.||Units on a scale||Standard Error|Least Squares Mean
804313|NCT00997438|Primary|Lipoic Acid Levels|Plasma concentration of LA|4 hours|Plasma samples from one secondary progressive and one healthy control subject did not yield results for unknown reason(s).||ng/mL||Standard Error|Mean
804213|NCT00996918|Secondary|Change From Extension Study Baseline in DAD Score at Weeks 13, 26, 39, 52 and 78|The DAD measures instrumental and basic activities of daily living in participants with AD. The DAD is administered to the participants’caregiver in the form of an interview. This scale had to be administered by a trained and certified psychometric rater who did not have access to any information regarding adverse events experienced by the participant. This scale assesses a participants’ ability to initiate, plan, and perform activities related to hygiene, dressing, continence, eating, meal preparation, telephoning, going on an outing, finance and correspondence, medications, leisure, and housework. Each item can be scored as 1 = yes, 0 = no, non applicable = NA. A total score is obtained by adding the rating for each question and converting this total score out of 100. Higher scores indicate better function; a positive change from baseline indicates an improvement|Weeks 13, 26, 39, 52 and 78|The Extension mITT Population was defined as all randomly assigned participants who received at least one dose of investigational product in the extension study and who had a baseline for the extension study and at least one valid post-baseline assessment of the ADAS-Cog total score and DAD total score in the extension study.||Units on a scale||Standard Error|Least Squares Mean
804214|NCT00996918|Secondary|Change From Base Study Baseline in Disability Assessment for Dementia (DAD) Score at Weeks 13, 26, 39, 52 and 78.|The DAD measures instrumental and basic activities of daily living in participants with Alzheimer's Disease (AD). The DAD is administered to the participants’caregiver in the form of an interview. This scale had to be administered by a trained and certified psychometric rater who did not have access to any information regarding adverse events experienced by the participant. This scale assesses a participants’ ability to initiate, plan, and perform activities related to hygiene, dressing, continence, eating, meal preparation, telephoning, going on an outing, finance and correspondence, medications, leisure, and housework. Each item can be scored as 1 = yes, 0 = no, non applicable = NA. A total score is obtained by adding the rating for each question and converting this total score out of 100. Higher scores indicate better function; a positive change from baseline indicates an improvement|Weeks 13, 26, 39, 52 and 78|The Extension mITT Population was defined as all randomly assigned participants who received at least one dose of investigational product in the extension study and who had a baseline for the extension study and at least one valid post-baseline assessment of the ADAS-Cog total score and DAD total score in the extension study.||Units on a scale||Standard Error|Least Squares Mean
804215|NCT00996918|Secondary|Change From Extension Study Baseline in ADAS-Cog/11 at Weeks 13, 26, 39, 52 and 78.|The ADAS-Cog is a multi-item, objective measure of cognitive function. The scale evaluates memory, language, and praxis with items such as orientation, word recall, word recognition, object identification, comprehension, and the completion of simple tasks. Analysis of the ADAS-Cog for this study was based upon an 11 item score from the following items 1) word recall task, 2) naming objects and fingers, 3) following commands, 4) constructional praxis, 5) ideational praxis, 6) orientation, 7) word recognition, 8) remembering test instructions, 9) spoken language ability, 10) word finding difficulty in spontaneous speech, and 11) comprehension.This scale had to be administered by a trained and certified psychometric rater who did not have access to any information regarding adverse events experienced. The ADAS-Cog/11 ranged from 0 to 70 points, with higher scores indicating a greater degree of impairment. A negative change from baseline indicates a decrease in cognitive impairment.|Weeks 13, 26, 39, 52 and 78|The Extension mITT Population was defined as all randomly assigned participants who received at least one dose of investigational product in the extension study and who had a baseline for the extension study and at least one valid post-baseline assessment of the ADAS-Cog total score and DAD total score in the extension study.||Units on a scale||Standard Error|Least Squares Mean
804216|NCT00996918|Secondary|Change From Base Study Baseline in Alzheimer's Disease Assesment Scale-Cognitive Subscale (ADAS-Cog/11) at Weeks 13, 26, 39, 52 and 78.|The ADAS-Cog is a multi-item, objective measure of cognitive function. The scale evaluates memory, language, and praxis with items such as orientation, word recall, word recognition, object identification, comprehension, and the completion of simple tasks. Analysis of the ADAS-Cog for this study was based upon an 11 item score from the following items 1) word recall task, 2) naming objects and fingers, 3) following commands, 4) constructional praxis, 5) ideational praxis, 6) orientation, 7) word recognition, 8) remembering test instructions, 9) spoken language ability, 10) word finding difficulty in spontaneous speech, and 11) comprehension.This scale had to be administered by a trained and certified psychometric rater who did not have access to any information regarding adverse events experienced. The ADAS-Cog/11 ranged from 0 to 70 points, with higher scores indicating a greater degree of impairment. A negative change from baseline indicates a decrease in cognitive impairment.|Weeks 13, 26, 39, 52 and 78|The Extension mITT Population was defined as all randomly assigned participants who received at least one dose of investigational product in the extension study and who had a baseline for the extension study and at least one valid post-baseline assessment of the ADAS-Cog total score and DAD total score in the extension study.||Units on a scale||Standard Error|Least Squares Mean
804217|NCT00996918|Primary|Number of Participants Reporting a Serious Adverse Event.|Safety was measured according to standard adverse event collection as described in the Adverse Event Section of the Results. Complete tables of events are provided there.|Up to Week 195|The Safety Population included all participants who consented to participate in the extension and received at least one dose of the investigational product (in the extension study).||Number of participants|||Number
804218|NCT00996931|Secondary|Change in Childhood Autism Rating Scale (CARS)Value From Baseline to 6 Weeks|Change in CARS value from baseline to 6 weeks. Total CARS scores range from a fifteen to 60, with a minimum score of thirty serving as the cutoff for a diagnosis of autism on the mild end of the autism spectrum.|Baseline and 6 weeks|Intention to treat||mean change in units on scale||Standard Deviation|Mean
804219|NCT00996931|Primary|Change in TNF-alpha Levels|Change in CSF-TNF-α from baseline to 12 weeks.|Baseline and 12 weeks|Intention to treat||mean % change||Standard Deviation|Mean
804220|NCT00996944|Secondary|Drug Clearance Rate On-Dialysis and Off-Dialysis During the Maintenance Dose Treatment Phase (in the Long-term Treatment Period)|For on-dialysis analysis, measurements were to have been taken 1 hour before dialysis, in the artery/vein at the beginning, during, and end of dialysis, and 1 hour after dialysis. For off-dialysis analysis, measurements were to have been taken 1 hour before dialysis, at the beginning, during, and end of dialysis, and 1 hour after dialysis.|Week 12 through Week 64|PK analysis was not performed because there were no participants (who had received a maintenance dose of the IP for more than 1 week in the long-term treatment period) from whom a blood sample could be collected when decision of study termination was made.|||||
804221|NCT00996944|Secondary|Mean Daily Number of Hours of RLS Symptoms by Timeframe for Participants Who Withdrew fn the Long-term Treatment Period (LONG WD)|Participants recorded the onset time and total duration of RLS symptoms on their diary cards for 7 days from one week before each visit. Timeframes were defined as follows: daytime, 7:00AM to 4:59PM; evening, 5:00PM to 7:59PM; and nighttime, 8:00PM to 6:59AM.|LONG WD (up to Week 64)|FAS. Only participants with symptoms who were able to record them in the diary card were included in the analyses of the and LONG WD data.||hours||Standard Deviation|Mean
804222|NCT00996944|Secondary|Mean Daily Number of Hours of RLS Symptoms by Timeframe for Participants Who Withdrew From the Double-Blind Treatment Period (DBT WD)|Participants recorded the onset time and total duration of RLS symptoms on their diary cards for 7 days from one week before each visit. Timeframes were defined as follows: daytime, 7:00AM to 4:59PM; evening, 5:00PM to 7:59PM; and nighttime, 8:00PM to 6:59AM.|DBT WD (up to Week 12)|FAS. Only participants with symptoms who were able to record them in the diary card were included in the analyses of the DBT WD data.||hours||Standard Deviation|Mean
804223|NCT00996944|Secondary|Mean Daily Number of Hours of RLS Symptoms by Timeframe at Week 0 and Week 12|Participants recorded the onset time and total duration of RLS symptoms on their diary cards for 7 days from one week before each visit. Timeframes were defined as follows: daytime, 7:00AM to 4:59PM; evening, 5:00PM to 7:59PM; and nighttime, 8:00PM to 6:59AM.|Week 0 and Week 12|FAS. Participants without symptoms were not included in the analysis of Week 0 data. Participants without symptoms and participants prematurely withdrawn from the study were not included in the analysis of Week 12 data.||hours||Standard Deviation|Mean
804224|NCT00996944|Secondary|Number of Participants With the Indicated Responses to the Patient Satisfaction Question for Participants Who Withdrew From the Double-Blind Treatment Period (DBT WD)|Participants responded to a question about their satisfaction with the IP on the following 1 to 7 scale: 1 = very much satisfied; 2 = satisfied; 3 = somewhat satisfied; 4 = neither satisfied nor dissatisfied; 5 = somewhat dissatisfied; 6 = dissatisfied; and 7 = very dissatisfied. At Week 0, participants responded to a question about their satisfaction with their prior medications.|DBT WD (up to Week 12)|FAS. Participants with missing DBT WD data were not included in the analysis.||participants|||Number
804225|NCT00996944|Secondary|Number of Participants With the Indicated Responses to the Patient Satisfaction Question for Participants Who Withdrew fn the Long-term Treatment Period (LONG WD)|Participants responded to a question about their satisfaction with the IP on the following 1 to 7 scale: 1 = very much satisfied; 2 = satisfied; 3 = somewhat satisfied; 4 = neither satisfied nor dissatisfied; 5 = somewhat dissatisfied; 6 = dissatisfied; and 7 = very dissatisfied. At Week 0, participants responded to a question about their satisfaction with their prior medications.|LONG WD (up to Week 64)|FAS. Participants with no measurement data in the long-term treatment period because of their premature withdrawal without receiving the IP in that period were not included in the analysis.||participants|||Number
804226|NCT00996944|Secondary|Number of Participants With the Indicated Responses to the Patient Satisfaction Question at Week 0 and Week 12|Participants responded to a question about their satisfaction with the IP on the following 1 to 7 scale: 1 = very much satisfied; 2 = satisfied; 3 = somewhat satisfied; 4 = neither satisfied nor dissatisfied; 5 = somewhat dissatisfied; 6 = dissatisfied; and 7 = very dissatisfied. At Week 0, participants responded to a question about their satisfaction with their prior medications.|Week 0 and Week 12|FAS. Participants withdrawn from the study before Week 12 were not included in the analysis.||participants|||Number
804227|NCT00996944|Secondary|The PSQI Total Score for Participants Who Withdrew fn the Long-term Treatment Period (LONG WD)|The PSQI consists of the following 7 domains: sleep quality, duration getting to sleep, sleep duration, sleep adequacy, sleep disturbance, use of sleeping pill, and somnolence. These domains are numerically scored from 0 to 3, with 0 representing the least severe response and 3 representing the most severe response. The PSQI total score is calculated by summing the individual domain scores. The highest possible score is 21, which represents the most disturbances in sleep quality; the lowest possible score is 0, which represents an absence of disturbances in sleep quality.|LONG WD (up to Week 64)|FAS. Participants with no measurement data in the long-term treatment period because of their premature withdrawal without receiving the IP in that period were not included in the analysis.||units on a scale||Standard Deviation|Mean
804228|NCT00996944|Secondary|The PSQI Total Score for Participants Who Withdrew From the Double-Blind Treatment Period (DBT WD)|The PSQI consists of the following 7 domains: sleep quality, duration getting to sleep, sleep duration, sleep adequacy, sleep disturbance, use of sleeping pill, and somnolence. These domains are numerically scored from 0 to 3, with 0 representing the least severe response and 3 representing the most severe response. The PSQI total score is calculated by summing the individual domain scores. The highest possible score is 21, which represents the most disturbances in sleep quality; the lowest possible score is 0, which represents an absence of disturbances in sleep quality.|DBT WD (up to Week 12)|FAS. Participants with missing DBT WD data were not included in this analysis.||units on a scale||Standard Deviation|Mean
804229|NCT00996944|Secondary|The Pittsburgh Sleep Quality Index (PSQI) Total Score at Week 0 and Week 12|The PSQI consists of the following 7 domains: sleep quality, duration getting to sleep, sleep duration, sleep adequacy, sleep disturbance, use of sleeping pill, and somnolence. These domains are numerically scored from 0 to 3, with 0 representing the least severe response and 3 representing the most severe response. The PSQI total score is calculated by summing the individual domain scores. The highest possible score is 21, which represents the most disturbances in sleep quality; the lowest possible score is 0, which represents an absence of disturbances in sleep quality.|Week 0 and Week 12|FAS. Participants withdrawn from the study before Week 12 were not included in the analysis.||units on a scale||Standard Deviation|Mean
804230|NCT00996944|Secondary|Johns Hopkins RLSQOL Questionnaire Overall Life Impact Score for Participants Who Withdrew in the Long-term Treatment Period (LONG WD)|The RLSQOL questionnaire is a participant-rated questionnaire designed to assess the impact of RLS on the lives of participants. It consists of 18 items, 10 of which contribute to a single summary score (overall life impact). The response for each item is coded from 1 to 5, with 1 representing the best quality of life and 5 representing the worst quality of life. The lowest possible overall life impact score is 0, and the highest possible overall life impact score is 100. The score of 100 represents the best possible quality of life.|LONG WD (up to Week 64)|FAS. Participants with no measurement data in the long-term treatment period because of their premature withdrawal without receiving the IP in that period were not included in the analysis.||units on a scale||Standard Deviation|Mean
804231|NCT00996944|Secondary|Johns Hopkins RLSQOL Questionnaire Overall Life Impact Score for Participants Who Withdrew From the Double-Blind Treatment Period (DBT WD)|The RLSQOL questionnaire is a participant-rated questionnaire designed to assess the impact of RLS on the lives of participants. It consists of 18 items, 10 of which contribute to a single summary score (overall life impact). The response for each item is coded from 1 to 5, with 1 representing the best quality of life and 5 representing the worst quality of life. The lowest possible overall life impact score is 0, and the highest possible overall life impact score is 100. The score of 100 represents the best possible quality of life.|DBT WD (up to Week 12)|FAS. Participants with missing DBT WD data were not included in the analysis.||units on a scale||Standard Deviation|Mean
804232|NCT00996944|Primary|IRLS Rating Scale Total Score for Participants Who Withdrew From the Double-Blind Treatment Period (DBT WD)|The IRLS rating scale is an investigator-rated scale consisting of 10 questions with a choice of 5 responses each. These responses are numerically scored from 0 (the least severe response) to 4 (the most severe response). The IRLS rating scale total score is calculated by summing the individual response scores. The highest possible score is 40, which represents the most severe RLS; the lowest possible score is 0, which represents an absence of RLS. A total of 17 participants were prematurely withdrawn from the study before Week 12, and 2 participants had missing DBT WD data.|DBT WD (up to Week 12)|Full Analysis Set (FAS): participants who were progressed to the treatment phase, but excluding those who did not have the target indication, those who had not received at least one dose of the investigational product, and those who did not have any measured efficacy data after initiation of the study treatment.||units on a scale||Standard Deviation|Mean
804233|NCT00996944|Secondary|Johns Hopkins Restless Legs Syndrome Quality of Life (RLSQOL) Questionnaire Overall Life Impact Score at Week 0 and Week 12|The RLSQOL questionnaire is a participant-rated questionnaire designed to assess the impact of RLS on the lives of participants. It consists of 18 items, 10 of which contribute to a single summary score (overall life impact). The response for each item is coded from 1 to 5, with 1 representing the best quality of life and 5 representing the worst quality of life. The lowest possible overall life impact score is 0, and the highest possible overall life impact score is 100. The score of 100 represents the best possible quality of life.|Week 0 and Week 12|FAS. Participants withdrawn from the study before Week 12 were not included in the analysis.||units on a scale||Standard Deviation|Mean
804234|NCT00996944|Secondary|Number of Participants With the Indicated CGI-I Scores for Participants Who Withdrew fn the Long-term Treatment Period (LONG WD)|The CGI-I assesses the participant's improvement or worsening of RLS from baseline with the following eight grades: 0 = Not Assessed, 1 = Very Much Improved, 2 = Much Improved, 3 = Minimally Improved, 4 = No Change, 5 = Minimally Worse, 6 = Much Worse, and 7 = Very Much Worse.|LONG WD (up to Week 64)|FAS. Participants with no measurement data in the long-term treatment period because of their premature withdrawal without receiving the IP in that period were not included in the analysis.||participants|||Number
804235|NCT00996944|Secondary|Number of Participants With the Indicated CGI-I Scores for Participants Who Withdrew From the Double-Blind Treatment Period (DBT WD)|The CGI-I assesses the participant's improvement or worsening of RLS from baseline with the following eight grades: 0 = Not Assessed, 1 = Very Much Improved, 2 = Much Improved, 3 = Minimally Improved, 4 = No Change, 5 = Minimally Worse, 6 = Much Worse, and 7 = Very Much Worse.|DBT WD (up to Week 12)|FAS. Participants with missing DBT WD data were not included in the analysis.||participants|||Number
804236|NCT00996944|Secondary|Number of Participants With the Indicated Clinical Global Impression–Improvement (CGI-I) Scores at Week 12|The CGI-I assesses the participant's improvement or worsening of RLS from baseline with the following eight grades: 0 = Not Assessed, 1 = Very Much Improved, 2 = Much Improved, 3 = Minimally Improved, 4 = No Change, 5 = Minimally Worse, 6 = Much Worse, and 7 = Very Much Worse.|Week 12|FAS. Participants withdrawn from the study before Week 12 were not included in the analysis.||participants|||Number
804237|NCT00996944|Secondary|IRLS Rating Scale Total Score for Participants Who Withdrew in the Long-term Treatment Period (LONG WD)|The IRLS rating scale is an investigator-rated scale consisting of 10 questions with a choice of 5 responses each. These responses are numerically scored from 0 (the least severe response) to 4 (the most severe response). The IRLS rating scale total score is calculated by summing the individual response scores. The highest possible score is 40, which represents the most severe RLS; the lowest possible score is 0, which represents an absence of RLS.|LONG WD (up to Week 64)|FAS. One participant in each group had no measurement data and thus was not included in the analysis. These two participants were withdrawn from the study without receiving the IP in the long-term treatment period.||units on a scale||Standard Deviation|Mean
804238|NCT00996944|Primary|International Restless Legs Syndrome (IRLS) Rating Scale Total Score at Week 0 and Week 12|The IRLS rating scale is an investigator-rated scale consisting of 10 questions with a choice of 5 responses each. These responses are numerically scored from 0 (the least severe response) to 4 (the most severe response). The IRLS rating scale total score is calculated by summing the individual response scores. The highest possible score is 40, which represents the most severe RLS; the lowest possible score is 0, which represents an absence of RLS. A total of 17 participants were prematurely withdrawn from the study before Week 12.|Week 0 and Week 12|Full Analysis Set (FAS): participants who were progressed to the treatment phase, but excluding those who did not have the target indication, those who had not received at least one dose of the investigational product, and those who did not have any measured efficacy data after initiation of the study treatment.||units on a scale||Standard Deviation|Mean
804239|NCT00996996|Secondary|Number of Participants Who Received Thyroid Medication After Treatment|Hypothyroidism is a condition in which the thyroid gland does not make enough thyroid hormone and is defined as either developing elevated TSH levels or initiating thyroid medication.|From Study Day 0 (start of treatment) up to 12 years (long-term follow up)|ITT-Exposed Population||participants|||Number
804240|NCT00996996|Secondary|Number of Participants With Low or Normal Baseline TSH Levels That Developed Hypothyroidism|Hypothyroidism is a condition in which the thyroid gland does not make enough thyroid hormone and is defined as either developing elevated TSH levels or initiating thyroid medication.|Baseline and up to 12 years from the start of treatment|ITT-Exposed Population. Only those participants who had low or normal Baseline TSH levels were assessed.||participants|||Number
804314|NCT00997438|Primary|Lipoic Acid Levels|Plasma concentration of LA|3 hours|Plasma samples from one secondary progressive and one healthy control subject did not yield results for unknown reason(s).||ng/mL||Standard Error|Mean
804241|NCT00996996|Secondary|Number of Participants With the Adverse Event (AEs) of Hypothyroidism|Hypothyroidism is a condition in which the thyroid gland does not make enough thyroid hormone and is defined as either developing elevated TSH levels or initiating thyroid medication. An AE is defined as any unfavorable and unintended sign, including an abnormal laboratory finding, symptom, or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered to be related to the medical treatment or procedure, that occurs during the course of the study.|Baseline and up to 12 years from the start of treatment|ITT-Exposed Population||participants|||Number
804242|NCT00996996|Secondary|Time to Elevated TSH Post Baseline for Participants Who Had Low or Normal TSH Levels at Baseline and Elevated Levels Post Baseline|TSH is a hormone that stimulates the thyroid gland to produce thyroxine (T4) and then triiodothyronine (T3), which stimulates the metabolism of almost every tissue in the body. Participants were categorized to have elevated or normal/low TSH values per the standard TSH ranges of the testing laboratory.|Baseline and up to 12 years from the start of treatment|ITT-Exposed Population. Only those participants who had low or normal TSH levels at Baseline and elevated levels post Baseline were assessed.||months||Full Range|Median
804243|NCT00996996|Secondary|Participants With Elevated TSH Levels at Baseline With Post Baseline TSH Levels of Low/Normal and Elevated|TSH is a hormone that stimulates the thyroid gland to produce thyroxine (T4) and then triiodothyronine (T3), which stimulates the metabolism of almost every tissue in the body. Participants were considered to have normal, high, or low TSH levels per the standard TSH ranges of the testing laboratory.|Baseline and up to 12 years (long-term follow up)|ITT-Exposed Population. Only participants with elevated TSH levels at Baseline were assessed.||participants|||Number
804244|NCT00996996|Secondary|Number of Participants With Elevated, Low, and Normal Thyroid Stimulating Hormone (TSH) Levels at Baseline|TSH is a hormone that stimulates the thyroid gland to produce thyroxine (T4) and then triiodothyronine (T3), which stimulates the metabolism of almost every tissue in the body. Participants were considered to have normal, high, or low TSH levels per the standard TSH ranges of the testing laboratory.|Baseline|ITT-Exposed Population. Only those participants for whom TSH levels were recorded at Baseline were assessed.||participants|||Number
804245|NCT00996996|Secondary|Time to HAMA Positivity From the First Dosimetric Dose|Tositumomab is a murine (mouse) antibody (immunoglobulin) of the IgG2a subclass. Participants were evaluated to determine whether they developed an immune response to study treatment, as evident by human anti-mouse antibodies (HAMA) after administration of tositumomab and iodine I-131 tositumomab. A positive HAMA value indicates that the participant developed HAMA above the HAMA assay threshold, and a negative HAMA value indicates either the absence or below threshold level of HAMA. HAMA assays were conducted in the laboratory to measure conversion to HAMA positivity following treatment.|From Baseline up to 2 years from the start of treatment|ITT-Exposed Population. Only those participants who converted from being negative for HAMA at Baseline to being positive for HAMA any time following treatment were assessed.||days||Standard Deviation|Mean
804246|NCT00996996|Secondary|Number of Participants With Conversion to HAMA Positivity Any Time During the Study From Baseline|Tositumomab is a murine (mouse) antibody (immunoglobulin) of the IgG2a subclass. Participants were evaluated to determine whether they developed an immune response to study treatment, as evident by human anti-mouse antibodies (HAMA) after administration of tositumomab and iodine I-131 tositumomab. A positive HAMA value indicates that the participant developed HAMA above the HAMA assay threshold, and a negative HAMA value indicates either the absence or below threshold level of HAMA. HAMA assays were conducted in the laboratory to measure conversion to HAMA positivity following treatment.|From Baseline up to 2 years from the start of treatment|ITT-Exposed Population. Only those participants who were evaluable for HAMA were assessed.||participants|||Number
804247|NCT00996996|Secondary|Number of Participants Evaluable and Not Evaluable for Human Anti-Murine Antibodies (HAMA)|Tositumomab is a murine (mouse) antibody (immunoglobulin) of the IgG2a subclass. Participants were evaluated to determine whether they developed an immune response to study treatment, as evident by human anti-mouse antibodies (HAMA) after administration of tositumomab and iodine I-131 tositumomab. A positive HAMA value indicates that the participant developed HAMA above the HAMA assay threshold, and a negative HAMA value indicates either the absence or below threshold level of HAMA.|From Baseline up to 2 years from the start of treatment|ITT-Exposed Population||participants|||Number
804248|NCT00996996|Secondary|Number of Participants With the Indicated Fatal Serious Adverse Events (SAE)|An SAE is any event occurring at any dose that results in any of the following: death, a life-threatening adverse drug experience (ADE; at immediate risk of death from the experience as it occurred), inpatient hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, or a congenital anomaly/birth defect. A fatal SAE is a medical event that results in death.|From Baseline up to 12 years from the start of treatment (long-term follow up)|ITT-Exposed Population||participants|||Number
804249|NCT00996996|Secondary|Normal Organ Dosimetry for the Indicated Organs|Organ dosimetry was performed in participants using the kidneys, liver, lungs, spleen, red marrow, urinary bladder, and the remainder of the body as source organs. Organ doses and Iodine I-131 Anti-B1 Antibody biodistribution were comparable across the three Anti-B1 Antibody manufacturers. Gamma camera images of participants were used to calculate the amount of radiation that accumulated in the target tumor and normal organs (tumor/organ dosimetry). For the spleen (corrected) category, participant-specific corrections were made to account for individual spleen size.|0-120 hours from the dosimetric dose (given only on Day 0) and 0-120 hours from the therapeutic dose (given only on Day 7)|ITT-Exposed Population. Only those participants who had available gamma camera images for the indicated organs were assessed.||cGy/75 cGy total body dose (TBD)||Standard Deviation|Mean
804250|NCT00996996|Secondary|Total Body Effective Half-life (EHL)|Total body EHL is the time required for a radioactive element in the body to be diminished by 50% as a result of radioactive decay and biologic elimination. The EHL is equal to the product of the biologic half-life (BHL) and the radioactive half-life (RHL) divided by the sum of the BHL and the RHL: EHL=(BHL * RHL)/(BHL + RHL). BHL is the time it takes for a drug to lose half of its pharmacologic, physiologic, or radiologic activity. RHL is the time taken for half of the radioactive nuclei to decay.|0-120 hours from the dosimetric dose (given only on Day 0) and 0-120 hours from the therapeutic dose (given only on Day 7)|ITT-Exposed Population||hours||Standard Deviation|Mean
804315|NCT00997438|Primary|Lipoic Acid Levels|Plasma concentration of LA|2 hours|Plasma samples from one secondary progressive and one healthy control subject did not yield results for unknown reason(s).||ng/mL||Standard Error|Mean
804251|NCT00996996|Secondary|Volume of Distribution at Infusion Time 0 (Vd0) and Steady State (Vdss)|Volume of distribution at the start of infusion and at steady state of I-131 tositumomab. The volume of distribution measures how much the drug spreads through the body after the dose. Steady state is defined as that state at which the overall intake of a drug is fairly in dynamic equilibrium with its elimination.|0-120 hours from the dosimetric dose (given only on Day 0) and 0-120 hours from the therapeutic dose (given only on Day 7)|ITT-Exposed Population. Only those participants for whom pharmacokinetic blood samples were collected at the indicated time points were assessed.||milliliters (ml)||Standard Deviation|Mean
804252|NCT00996996|Secondary|Maximum Concentration (Cmax) Values|Cmax is the maximum observed I-131 tositumomab concentration from time zero (end of the dosimetric dose infusion) to 120 hours after the end of the infusion. Unit: %ID/ml, where %ID/ml is the percentage of the injected dose per milliliter of blood. Cmax is the highest drug concentration in the blood after infusion.|0-120 hours from the dosimetric dose (given only on Day 0) and 0-120 hours from the therapeutic dose (given only on Day 7)|ITT-Exposed Population. Only those participants for whom pharmacokinetic blood samples were collected at the indicated time points were assessed.||%ID/ml||Standard Deviation|Mean
804253|NCT00996996|Secondary|Clearance Values|Clearance of I-131 tositumomab after intravenous administration was measured. The clearance of a drug measures the rate at which the drug is removed from the body after the dose.|0-120 hours from the dosimetric dose (given only on Day 0) and 0-120 hours from the therapeutic dose (given only on Day 7)|ITT-Exposed Population. Only those participants for whom pharmacokinetic blood samples were collected at the indicated time points were assessed.||Milliliters per hour (ml/hr)||Standard Deviation|Mean
804254|NCT00996996|Secondary|Area Under the Curve (AUC) at 0 to 120 Hours and 0 to Infinity Hours|Area under the concentration-time curve for I-131 tositumomab from time 0 to 120 hours and time 0 to infinity hours (extrapolated) after the end of the dosimetric dose infusion was measured. Unit: %ID*h/ml, where %ID/ml is the percentage of the injected dose per milliliter of blood. AUC measures how much drug is in the system over time after infusion.|0-120 hours and 0-infinity hours from the dosimetric dose (given only on Day 0) and 0-120 hours and 0-infinity hours from the therapeutic dose (given only on Day 7)|ITT-Exposed Population. Only those participants for whom pharmacokinetic blood samples were collected at the indicated time points were assessed.||%ID*h/ml||Standard Deviation|Mean
804255|NCT00996996|Secondary|Terminal Half-life (t1/2beta)|t1/2 beta is the estimated terminal or beta phase half-life in a two-compartmental pharmacokinetic model. Half-life measures how long it takes for the concentration of drug in the blood to decrease by half.|0-120 hours from the dosimetric dose (given only on Day 0) and 0-120 hours from the therapeutic dose (given only on Day 7)|ITT-Exposed Population. Only those participants for whom pharmacokinetic blood samples were collected at the indicated time points were assessed.||hours||Standard Deviation|Mean
804256|NCT00996996|Secondary|Initial Half-life (t1/2alpha)|t1/2 alpha is the estimated initial or alpha phase half-life in a two-compartmental pharmacokinetic model. Half-life measures how long it takes for the concentration of drug in the blood to decrease by half.|0-120 hours from the dosimetric dose (given only on Day 0) and 0-120 hours from the therapeutic dose (given only on Day 7)|ITT-Exposed Population. Only those participants for whom pharmacokinetic blood samples were collected at the indicated time points were assessed.||hours||Standard Deviation|Mean
804257|NCT00996996|Secondary|Progression-free Survival (PFS) Based on Participants’ Baseline PCR Status|PCR is a scientific technique in molecular biology to amplify a single copy or a few copies of a piece of deoxyribonucleic acid (DNA) across several orders of magnitude, generating thousands to millions of copies of a particular DNA sequence. Applications of PCR technique include: selective DNA isolation, amplification and quantification of DNA, and the diagnosis of diseases. PCR positive: interchromosomal translocation t(14;18) is present. PCR negative: t(14;18) is absent. PFS is defined as the time from the dosimetric dose to the first documented occurrence of disease progression or death.|Baseline and up to 12 years (long-term follow up)|ITT-Exposed Population. Only those participants with a PCR status taken at Baseline were evaluated for PFS.||months||95% Confidence Interval|Median
804258|NCT00996996|Secondary|Duration of Response (the Time From the First Documented Response to the First Documented Progression) for Participants Who Were PCR Positive at Baseline and Converted to PCR Negative Status After Treatment|PCR is a scientific technique in molecular biology to amplify a single copy or a few copies of a piece of deoxyribonucleic acid (DNA) across several orders of magnitude, generating thousands to millions of copies of a particular DNA sequence. Applications of PCR technique include: selective DNA isolation, amplification and quantification of DNA, and the diagnosis of diseases. PCR positive: interchromosomal translocation t(14;18) is present. PCR negative: t(14;18) is absent.|Baseline and up to 12 years (long-term follow up)|ITT-Exposed Population. Only those participants who were PCR positive at Baseline and converted to a status of PCR negative were assessed.||months||95% Confidence Interval|Median
804259|NCT00996996|Secondary|Number of Participants Who Were Polymerase Chain Reaction (PCR)-Positive at Baseline With Bone Marrow Conversion to a Status of PCR Positive and Negative Any Time After Treatment|PCR is a scientific technique in molecular biology to amplify a single copy or a few copies of a piece of deoxyribonucleic acid (DNA) across several orders of magnitude, generating thousands to millions of copies of a particular DNA sequence. Applications of PCR technique include: selective DNA isolation, amplification and quantification of DNA, and the diagnosis of diseases. PCR positive: interchromosomal translocation t(14;18) is present. PCR negative: t(14;18) is absent.|Baseline and up to 12 years (long-term follow up)|ITT-Exposed Population. Only those participants with a PCR-positive status at Baseline were assessed. One participant had a Baseline measurement but no post Baseline measure, and was thus not assessed.||participants|||Number
804260|NCT00996996|Secondary|Number of Participants With Resolution of All Baseline B-symptoms by the End of the Study|"The Ann Arbor staging system of lymphomas is used to summarize the extent of the cancer's spread. Stages are classified by Roman numerals I (less spread) to IV (more spread). If the following symptoms (called B-symptoms) are present, a B classification is added to the stage: night sweats, intermittant fever, and weight loss. B-symptoms indicate the presence of systemic symptoms. The presence or absence of B-symptoms has prognostic significance and is reflected in the staging of these lymphomas."|Baseline and up to 12 years (long-term follow up)|ITT-Exposed Population. Only those participants who experienced any B-symptom at Baseline were assessed. Not all participants experienced all B-symptoms at Baseline; thus, the number of participants analyzed represents all participants who experienced at least one B-symptom.||participants|||Number
804261|NCT00996996|Secondary|Time to Progression of Disease or Death (Progression-free Survival)|Time to progression is defined as the time from the treatment start date to the first documented progression or death. Progressive Disease is defined as a >=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion.|From Study Day 0 (start of treatment) up to 12 years (long-term follow up)|ITT-Exposed Population. Only those participants who experienced disease progression or died were assessed.||months||95% Confidence Interval|Median
804262|NCT00996996|Secondary|Overall Survival|Overall survival is defined as the time from the treatment start date to the date of death from any cause.|From Study Day 0 (start of treatment) up to 12 years (long-term follow up)|ITT-Exposed Population. Only those participants who died during the study due to any cause were assessed.||months||95% Confidence Interval|Median
804263|NCT00996996|Secondary|The Estimated Value Represents the Percentage of Participants With a PR|Duration of response (CR, CCR, or PR) is defined as the time from the first documented response to the first documented progression. Progressive Disease (PD) is defined as a >=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion.|From Study Day 0 (start of treatment) up to 12 years (long-term follow up)|ITT-Exposed Population. Only participants who experienced confirmed CR, CCR, or PR with PD were assessed. Response (R) had to be confirmed by a consecutive R that was the same or better >=4 weeks apart. Each individual confirmed R category only counts the R confirmed by the exact same R; therefore, not all possible combinations are represented.||months||95% Confidence Interval|Median
804264|NCT00996996|Primary|Number of Participants With Complete Response (CR, CCR, and CR+CCR) and Partial Response (PR)|CR: Complete resolution of all disease-related radiological abnormalities and disappearance of all signs and symptoms related to the disease. CCR: Complete resolution of all disease-related symptoms, but residual foci, thought to be residual scar tissue, are present. PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions with no new lesions.|From Study Day 0 (start of treatment) up to 12 years (long-term follow up)|ITT-Exposed Population||participants|||Number
804265|NCT00996996|Primary|Number of Participants With Confirmed Complete Response (CR, CCR, and CR+CCR) and Partial Response (PR)|Responses were confirmed by two separate response evaluations at least 4 weeks apart. CR: Complete resolution of all disease-related radiological abnormalities and disappearance of all signs and symptoms related to the disease. CCR: Complete resolution of all disease-related symptoms, but residual foci, thought to be residual scar tissue, are present. PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions with no new lesions.|From Study Day 0 (start of treatment) up to 12 years (long-term follow up)|ITT-Exposed Population. Only participants evaluable for confirmed response (R) were assessed. R had to be confirmed by a consecutive R that was the same or better >=4 weeks apart. Each individual confirmed R category only counts the R confirmed by the exact same R; therefore, not all possible combinations are represented in the table.||participants|||Number
804266|NCT00996996|Primary|Number of Participants With Response, Including Participants With Complete Response (CR), Clinical Complete Response (CCR), or Partial Response (PR)|CR: Complete resolution of all disease-related radiological abnormalities and disappearance of all signs and symptoms related to the disease. CCR: Complete resolution of all disease-related symptoms, but residual foci, thought to be residual scar tissue, are present. PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions with no new lesions.|From Study Day 0 (start of treatment) up to 12 years (long-term follow up)|ITT-Exposed Population||participants|||Number
804267|NCT00996996|Primary|Number of Participants With Confirmed Response, Including Participants With Complete Response (CR), Clinical Complete Response (CCR), and Partial Response (PR)|Confirmed response required CR, CCR, or PR, which were confirmed by 2 separate response evaluations >=4 weeks apart. CR: Complete resolution of all disease-related radiological abnormalities and disappearance of all signs and symptoms related to the disease. CCR: Complete resolution of all disease-related symptoms, but residual foci, thought to be residual scar tissue, are present. PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions with no new lesions.|From Study Day 0 (start of treatment) up to 12 years (long-term follow up)|ITT-Exposed Population: all participants who were enrolled in the study and received at least one dose of study drug. Only participants evaluable for confirmed response were assessed.||participants|||Number
804268|NCT00997035|Secondary|Minimum Inhibitory Concentration of Isolates|Comparing Minimum inhibitory concentration of isolates by treatment arm|3 months after enrollment||12/2017||||
804269|NCT00997035|Secondary|Number of Adverse Events|Comparing the number of serious and non-serious adverse events by treatment arm.|3-months from enrollment|||adverse events|||Number
804270|NCT00997035|Secondary|Microbiological Cure at 7 Days|Fungal Culture negative at 7 days post treatment|7 days|Fungal Culture negative at 7 days post treatment||Participants|||Count of Participants
804271|NCT00997035|Secondary|Hazard Ratio for Re-epithelialization|Hazard Ratio of re-epithelialization comparing the treatment groups|Up to 21 days|||Number re-epthelialized/person-days|||Number
804272|NCT00997035|Secondary|Size of Infiltrate/Scar|Size of infiltrate/scar at 3 weeks after enrollment, using enrollment infiltrate scar/size as a covariate|3 weeks after enrollment|Mean infiltrate scar size at three weeks.||mm^2||Standard Error|Mean
804273|NCT00997035|Secondary|Size of Infiltrate/Scar - 3 Months|Size of infiltrate/scar at 3 months after enrollment, using enrollment infiltrate scar/size as a covariate|3 months after enrollment|Mean infiltrate scar size at three months correcting for baseline scar size and site||mm^2||Standard Error|Mean
804274|NCT00997035|Secondary|Best Spectacle-corrected logMAR Visual Acuity at 3-weeks|Best spectacle-corrected logMAR visual acuity at 3 weeks after enrollment, adjusting for enrollment BSCVA and treatment arm in a multiple linear|3 weeks after enrollment|Best spectacle-corrected logMAR visual acuity at 3 weeks after enrollment, adjusting for enrollment BSCVA and study site.||logMAR||Standard Error|Mean
804275|NCT00997035|Secondary|Best Spectacle-corrected logMAR Visual Acuity|Best spectacle-corrected logMAR visual acuity at 3 months after enrollment, adjusting for enrollment BSCVA and treatment arm in a multiple linear|3 months after enrollment|Best spectacle-corrected logMAR visual acuity at 3 weeks after enrollment, adjusting for enrollment BSCVA and study site||logMAR||Standard Error|Mean
815826|NCT01102374|Secondary|Change in Parathyroid Hormone Level||Baseline and 12 months|Issue relating to sample collection/processing precluded measurement of PTH level in the trial|||||
804276|NCT00997035|Primary|Incidence of Perforation or Therapeutic Penetrating Keratoplasty|Hazard ratio of perforation or therapeutic penetrating keratoplasty (TPK) comparing voriconazole to placebo|3 months from enrollment|Comparison of rate of perforation or TPK between the treatment groups (topical voriconazole with oral voriconazole vs. topical voriconazole with oral placebo)||New perforations or TPK/person-days|||Number
804277|NCT00997113|Secondary|Patient Reported Pain and Recall of the Painful Procedure for Which They Were Sedated Measure by Patient Query After They Had Regained Their Baseline Level of Consciousness After the Procedure|Pain and recall were measured seperately by direct patient query. The patient was asked if they experienced any pain during the procedure. The patient was then asked if they could recall any part of the fracture reduction. Patients who had either pain with the procedure of recall of the procedure were counted as having pain or recall with the procedure.|single time point measured after sedation procedure completed|||participants|||Number
804278|NCT00997113|Secondary|Respiratory Depression|categorized as a change in end tidal CO2 from baseline >10mmhg, a loss of end tidal CO2 waveform for more than 6 seconds, or an oxygen saturation less than 93%.|From one minute prior to the start of the sedation procedure until the patient has returned to baseline mental status|||participants|||Number
804279|NCT00997113|Primary|Change in Serum Catecholamines|change in serum catecholamine levels, values indicate a decrease over the procedure. These patients underwent fracture reduction procedures which are typically associated with an increase in catecholamines.|one minute prior to the start of the procedure and immediately at the end of sedation procedure (median time of procedure 12 minutes range 6-26 minutes|||mcg/ml||Inter-Quartile Range|Median
804280|NCT00997126|Secondary|Patient Reported Recall of the Procedure||Single measurement immediately after patient returns to baseline mental status after sedation procedure|||participants|||Number
804281|NCT00997126|Secondary|Patient Reported Pain||Single measurement immediately after patient returns to baseline mental status after sedation procedure|||participants|||Number
804282|NCT00997126|Secondary|Depth of Sedation Measured Using the OAAS Scale|Observers Assesment of Alertness Scale, 5 responds normally to voice, 4 lethargic response to voice, 3 responds only to loud voice or light touch, 2 responds only to mild prodding or shaking, 1 responds only to painful stimuli, 0 no response to painful stimuli|Single measurement during sedation procedure|||units on a scale||Inter-Quartile Range|Median
804283|NCT00997126|Secondary|Time to Return of Baseline Mental Status From Start of Procedure in Minutes||Single time point after completion of sedation procedure, measured from start of procedure until the patient returns to baseline mental status up to 24 hours|||minutes||Inter-Quartile Range|Median
804284|NCT00997126|Primary|Number of Participants With Sub-clinical Respiratory Depression and Clinical Events Associated With Respiratory Depression During the Sedation Procedure||From one minute prior to start of procedure until the patient has returned to baseline mental status after the conclusion of the sedation procedure (~3-60 minutes depending on procedure duration)|||participants|||Number
804285|NCT00997139|Primary|MRSA Clearance Rate|Percentage of subjects with methicillin-resistant S. aureus on Baseline culture who achieved clearance with treatment.|14 days|||percentage of subjects|||Number
804286|NCT00997139|Primary|MSSA Clearance Rate|Percentage of subjects with methicillin-sensitive S. aureus on Baseline culture who achieved clearance with treatment.|14 days|||percentage of subjects|||Number
804287|NCT00997139|Primary|Carrier Rate for Staphylococcus Aureus|Percentage of subjects with baseline culture positive for Staphylococcus aureus (via nasal swab)|Baseline|||percentage of subjects|||Number
804288|NCT00997204|Secondary|Clinical Efficacy of Self-treatment of Acute HAE Attacks With s.c. Injections of Icatibant, Time to Symptom Relief Using VAS Score for a Single Primary Symptom by Patient Cohort|Subjects assessed angioedema attack symptoms using the visual analogue scale (VAS) for skin pain, skin swelling and abdominal pain. The VAS is a continuous scale comprised of a 100 mm in length line, anchored by 2 verbal descriptors, one for each symptom extreme 0 (no pain) and 100 (worst pain). The respondent is asked to place a mark on the VAS line (any where between 0 and 100 mm) at the point that represents their pain intensity. The score is determined by measuring the distance (mm) on the line between the “no pain” anchor and the patient’s mark, providing a range of scores from 0–100. A higher score indicates greater pain intensity. Score interpretation is: no pain (0–4 mm), mild pain (5–44 mm), moderate pain (45–74 mm), and severe pain (75–100 mm). Symptom relief is defined as at least a 50% reduction in a pre-dose VAS score of 30 mm or greater. The time to onset of symptom relief is defined as the first of 3 consecutive assessments at which symptom relief was observed.|48 hours post-dose|||Hours||Inter-Quartile Range|Median
804289|NCT00997204|Primary|Number of Participants With Adverse Events in Self-treatment of Acute HAE Attacks With s.c. Injections of Icatibant|"Clinical safety of self-treatment of acute HAE attacks with s.c. injections of icatibant was assessed by calculating the number of AEs occurred during the study. Only those adverse events occurring up to the earlier of 7 days from the start of the naive phase, study discontinuation and start of the self-administration phase are assessed.
The Local Tolerability Assessment tool was used. Subjects and Investigators graded erythema/reddening, swelling, burning, pruritus/itching, warm sensation, and skin pain on a 0 to 3 severity scale."|7 days from the beginning of each phase|||participants|||Number
804290|NCT00997243|Secondary|Explore the Biologic Role of microRNAs in Determining Clinical Response to the AZA Plus Lintuzumab Combination and Achievement of the Other Pharmacodynamic Endpoints||Up to 5 years|No participants were analyzed due to withdrawal of the investigational agent by the company.|||||
804291|NCT00997243|Secondary|Perform Exploratory Studies of AZA-triphosphate With Global DNA Methylation||up to 5 years|No participants were analyzed due to withdrawal of the investigational agent by the company.|||||
804292|NCT00997243|Secondary|Provide Preliminary Data on the Biological Activity of AZA as a Demethylating Agent (Changes in Target Gene Methylation and Gene Expression, DNMT1[Deoxyribonucleic Acid Methyltransferase 1 DNA Methyltransferase 1]Protein Expression, Global Methylation)||up to 5 years|No participants were analyzed due to withdrawal of the investigational agent by the company.|||||
804293|NCT00997243|Secondary|Determine the Relationship Between Pretreatment Expression of Syk and Clinical Response; to Determine Whether the Investigational Agents Modulate Syk Expression and Correlate Drug-induced Changes in Syk With Response to Treatment||up to 5 years|No participants were analyzed due to withdrawal of the investigational agent by the company.|||||
815827|NCT01102374|Secondary|Change in 25-hydroxyvitamin D (25OHD) Level||Baseline and 12 months|||ng/mL||Standard Error|Mean
804294|NCT00997243|Secondary|Toxicities of the Combination|All patients who received study drug were closely monitored for adverse events (AEs). All AEs that occured during study period were reported and the investigator determined the severity and relationship to study drug (unrelated, unlikely, possibly, probably, or definitely related). The NCI's CTCAE(Common Toxicity Criteria for Adverse Effects)v3.0 was used for grading AEs.|up to 5 years|||percentage of participants|||Number
804295|NCT00997243|Secondary|Overall Response Rate|Response to therapy was determined based on percentage of blasts in bone marrow, hematopoiesis, and requirement for supportive care (i.e., transfusions or cytokine growth factors). The modified International Working Group response criteria was used, based on Cheson, et al.|up to 5 years|||percentage of participants|||Number
804296|NCT00997243|Primary|Complete Response Rate|Response to therapy was determined based on percentage of blasts in bone marrow, hematopoiesis, and requirement for supportive care (i.e., transfusions or cytokine growth factors). The modified International Working Group response criteria was used, based on Cheson, et al.|up to 5 years|||percentage of participants|||Number
804297|NCT00997321|Secondary|Depth of Sedation|Observes assesment of alertness scale, 1-5 ordinal scale measuring level of awareness, one represents awake, 5 general anesthesia/unresponsive to pain|single measurement during sedation procedure|100 patients were randomized, 50 to the propofol group, 50 of whom underwent sedation, and 50 in the ketamine group, 47 of whom underwent sedation||score on a scale||Full Range|Median
804298|NCT00997321|Secondary|Patient Reported Pain or Recall of the Procedure|"patient completed question after return to baseline mental status did you feel pain during the procedure and do you remember any part of the procedure answered by circling yes or no on a question sheet, positive if yes to either question"|single measurement immediately after patient returns to baseline mental status after sedation procedure|100 patients were randomized, 50 to each group, 50 underwent the procedure in the propofol group and 47 in the ketamine group||percentage of participants||95% Confidence Interval|Number
804299|NCT00997321|Secondary|Time to Return of Baseline Mental Status|time in seconds from the first dose of medication until the patient has regained baseline mental status|from start of procedure until the return of baseline mental status up to 120 minutes|50 patients were randomized to the propofol group and 50 to ketamine, 50 underwent the procedure in the propofol group and 47 in the ketamine group||minutes||95% Confidence Interval|Median
804300|NCT00997321|Primary|Respiratory Depression (Sub-clinical and Clinical Signs)|binary measure based on the occurrence of an oxygen saturation less than 93 at any time, a change in baseline end tidal co2 >10 or an absence on capnographic waveform|From one minute prior to start of the procedure until the patient has returned to baseline mental status after the conclusion of the sedation procedure up to 60 minutes)|50 subjects were randomized to each group, 50 subjects in the propofol arm completed the study, 47 in the ketamine arm||percentage of participants||95% Confidence Interval|Number
804301|NCT00997334|Post-Hoc|Feasibility Rate|Feasibility in this study is defined as the percentage of patients who completed a repeated biopsy per protocol after evidence of disease progression.|Disease was evaluated radiologically every 8 weeks on treatment (cycle duration=4 weeks). Participants were treated until evidence of disease progression or unacceptable toxicity. Progression follow-up was up to 3 years in this study cohort.|The analysis dataset is comprised of all patients eligible for repeat biopsy.||percentage of participants||90% Confidence Interval|Number
804302|NCT00997334|Post-Hoc|Time to Repeat Biopsy|Time to repeat biopsy is the duration of time from clinical determination of progressive disease to time of repeat biopsy.|At time of removal from study, patients were asked to undergo a repeat biopsy of their progressing or new tumor lesion. Progression follow up was up to 3 years in this study cohort.|The analysis dataset is comprised of all evaluable patients.||days||Full Range|Median
804303|NCT00997334|Secondary|Progression-Free Survival|Progression-free survival based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) or death. Per RECIST 1.1 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.|Disease was evaluated radiologically every 8 weeks on treatment (cycle duration=4 weeks). Participants were treated until evidence of disease progression or unacceptable toxicity. Progression follow-up was up to 3 years in this study cohort.|The analysis dataset is comprised of all treated patients.||months||95% Confidence Interval|Median
804304|NCT00997334|Primary|Resistance Mechanism|Participants were classified into 4 potential resistant mechanism groups (4 genetic/ 1 histologic) based on evaluation of rebiopsy tissue: EGFR mutations (T790M mutation, exon 20 insertion), KRAS mutations, MET amplification or small-cell lung cancer (SCLC) transform using established methods.|Participants were evaluated for incidence of genetic mechanisms of secondary resistance at time of disease progression at which point participants stopped treatment. Progression follow up was up to 3 years in this study cohort.|The analysis dataset is comprised of all evaluable patients.||participants|||Number
804305|NCT00997373|Primary|Changes in Ki67 Expression After About 3 Weeks of Letrozole Treatment for Patients With Endometrial Cancer|Changes in %Ki67 staining cells by immunoperoxidase of paraffin embedded, formalin fixed tissue|At time of consent and after hysterectomy (generally about 3 weeks)|"Subjects completing treatment who had confirmed histopathology compared to a non-randomized group of untreated control subjects. Aromatase inhibitor responsiveness was defined as a proportionate decline in %Ki67 staining of at least 70% between pre-treatment biopsy and hysterectomy 9or repeat biopsy)."||percentage of Ki67 staining cells||Full Range|Mean
804306|NCT00997425|Primary|Number and Means of Exit Seeking (Door Approach Behaviors) and Exit Door Pass Through Behaviors (Eloping)|Door and floor cover interventions were compared for efficacy in reducing wandering behavior defined as patient approaching or passing through the equipped exit door. Counts of each behavior were collected on each patient for each intervention period. Mean values of counts were compared.|eight weeks|per protocol||behavior counts||Standard Error|Mean
804307|NCT00997438|Secondary|RANTES Levels||48 hour|Analyses were terminated when it became clear no consistent significant changes in RANTES were taking place.||pg/mL||Standard Error|Mean
804308|NCT00997438|Secondary|RANTES Levels||24 hour|Analyses were terminated when it became clear no consistent significant changes in RANTES were taking place.||pg/mL||Standard Error|Mean
815828|NCT01102374|Secondary|Time to First ARI||12 months|||Hazard Ratio|||Number
804317|NCT00997503|Secondary|Rate of Stent Thrombosis (Protocol Definition)|"-Binary rate
The occurrence of any of the following:
Clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis:
Angiographic documentation of acute complete occlusion (TIMI flow 0 or 1) of a previously successfully treated artery (TIMI flow 2 to 3 immediately after stent placement and diameter stenosis less than or equal to 30%) and/or Angiographic documentation of a flow limiting thrombus within or adjacent to a previously successfully treated lesion
Acute MI in the distribution of the treated vessel.
Death within the first 30 days post index procedure (without other obvious cause) is considered a surrogate for stent thrombosis when angiography is not available."|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.||percentage of participants|||Number
804318|NCT00997503|Secondary|Rate of Stent Thrombosis (Protocol Definition)|"-Binary rate
The occurrence of any of the following:
Clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis:
Angiographic documentation of acute complete occlusion (TIMI flow 0 or 1) of a previously successfully treated artery (TIMI flow 2 to 3 immediately after stent placement and diameter stenosis less than or equal to 30%) and/or Angiographic documentation of a flow limiting thrombus within or adjacent to a previously successfully treated lesion
Acute MI in the distribution of the treated vessel.
Death within the first 30 days post index procedure (without other obvious cause) is considered a surrogate for stent thrombosis when angiography is not available."|6 months|There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.||percentage of participants|||Number
804319|NCT00997503|Secondary|Rate of Stent Thrombosis (ARC Definite + Probable)|"ARC - Academic Research Consortium
Binary Rate"|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.||percentage of participants|||Number
804320|NCT00997503|Secondary|Rate of Stent Thrombosis (ARC Definite + Probable)|"ARC - Academic Research Consortium
Binary rate"|6 months|There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.||percentage of participants|||Number
804321|NCT00997503|Secondary|Rate of Major Bleeding|"Major Bleeding defined as the composite of severe or moderate bleeding complication (based upon GUSTO classification).
Binary rate"|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.||percentage of participants|||Number
804322|NCT00997503|Secondary|Rate of Major Bleeding|"Major Bleeding defined as the composite of severe or moderate bleeding complication (based upon GUSTO classification).
Binary rate"|6 months|There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.||percentage of participants|||Number
804323|NCT00997503|Secondary|Rate of Stroke|-Binary Rate|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.||percentage of participants|||Number
804324|NCT00997503|Secondary|Rate of Stroke|-Binary Rate|6 months|There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.||percentage of participants|||Number
804325|NCT00997503|Secondary|Rate of Target Vessel Reintervention (TVR): Study Stent Related|-Binary rate|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.||percentage of participants|||Number
804326|NCT00997503|Secondary|Rate of Target Vessel Reintervention (TVR): Study Stent Related|-Binary rate|6 months|There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.||percentage of participants|||Number
804327|NCT00997503|Secondary|Rate of Target Vessel Reintervention (TVR)|-Binary rate|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.||percentage of participants|||Number
804328|NCT00997503|Secondary|Rate of Target Vessel Reintervention (TVR)|-Binary rate|6 months|There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.||percentage of participants|||Number
804329|NCT00997503|Secondary|Rate of Myocardial Infarction (MI): Study Stent Related|-Binary rate|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.||percentage of participants|||Number
804330|NCT00997503|Secondary|Rate of Myocardial Infarction (MI): Study Stent Related|-Binary rate|6 months|There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.||percentage of participants|||Number
804331|NCT00997503|Secondary|Rate of Myocardial Infarction (MI)|-Binary rate|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.||percentage of participants|||Number
804332|NCT00997503|Secondary|Rate of Myocardial Infarction (MI)|-Binary rate|6 months|There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.||percentage of participants|||Number
804333|NCT00997503|Secondary|Rate of Cardiac Death: Study Stent Related|-Binary rate|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.||percentage of participants|||Number
804334|NCT00997503|Secondary|Rate of Cardiac Death: Study Stent Related|-Binary rate|6 months|There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.||percentage of participants|||Number
804335|NCT00997503|Secondary|Rate of Cardiac Death|-Binary rate|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.||percentage of participants|||Number
804336|NCT00997503|Secondary|Rate of Cardiac Death|-Binary rate|6 months|There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.||percentage of participants|||Number
804337|NCT00997503|Secondary|Rate of All Cause Death|-Binary rate|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.||percentage of participants|||Number
804338|NCT00997503|Secondary|Rate of All Cause Death|-Binary rate|6 months|There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.||percentage of participants|||Number
804339|NCT00997503|Secondary|Rate of Cardiac Death or Myocardial Infarction (MI)|- Binary Rate|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.||percentage of participants|||Number
804340|NCT00997503|Secondary|Rate of Cardiac Death or Myocardial Infarction (MI)|- Binary Rate|6 months|There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.||percentage of participants|||Number
804341|NCT00997503|Secondary|Rate of Target Vessel Failure (TVF)|"Target vessel failure is defined as any revascularization of the target vessel, MI (Q- and non-Q wave) related to the target vessel, or death related to the target vessel.
Binary rate"|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.||percentage of participants|||Number
804342|NCT00997503|Secondary|Rate of Target Vessel Failure (TVF)|"Target vessel failure is defined as any revascularization of the target vessel, MI (Q- and non-Q wave) related to the target vessel, or death related to the target vessel.
Binary Rate"|6 months|There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.||percentage of participants|||Number
804343|NCT00997503|Secondary|Rate of Major Adverse Cardiac Events (MACE): Study Stent Related|"MACE defined as the composite of cardiac death, myocardial infarction and target vessel revascularization.
Binary rate"|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.||percentage of participants|||Number
804344|NCT00997503|Secondary|Rate of Major Adverse Cardiac Events (MACE): Study Stent Related|"MACE defined as the composite of cardiac death, myocardial infarction and target vessel revascularization.
Binary rate"|6 months|There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.||percentage of participants|||Number
804345|NCT00997503|Secondary|Rate of Major Adverse Cardiac Events (MACE)|"MACE defined as the composite of cardiac death, myocardial infarction and target vessel revascularization.
Binary rate"|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.||percentage of participants|||Number
804346|NCT00997503|Secondary|Rate of Major Adverse Cardiac Events (MACE)|"MACE defined as the composite of cardiac death, myocardial infarction and target vessel revascularization.
Binary rate"|6 months|There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.||percentage of participants|||Number
804347|NCT00997503|Secondary|Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE): Study Stent Related|"MACCE defined as the composite of cardiac death, myocardial infarction, target vessel revascularization and stroke.
Binary rate"|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.||percentage of participants|||Number
804348|NCT00997503|Secondary|Rate of Major Adverse Cardiac & Cerebrovascular Events (MACCE): Study Stent Related|MACCE defined as the composite of cardiac death, myocardial infarction, target vessel revascularization and stroke.|6 months|There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.||percentage of participants|||Number
804349|NCT00997503|Secondary|Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE)|"MACCE defined as the composite of cardiac death, myocardial infarction, target vessel revascularization and stroke.
Binary rate"|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.||percentage of participants|||Number
804350|NCT00997503|Secondary|Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE)|"MACCE defined as the composite of cardiac death, myocardial infarction, target vessel revascularization and stroke.
Binary rate"|6 months|There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.||percentage of participants|||Number
804351|NCT00997503|Secondary|Target Vessel Failure (TVF) for the Medically-Treated Diabetic Population|Target vessel failure (TVF) for TAXUS Libertē Post-Approval Study medically-treated diabetic population. For pooled data from the TAXUS Liberté population, please see the citations|12 months|To be included, subject was a medically treated diabetic at the time of enrollment. Also, subjects met the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure. There were 2945 subjects that did not meet the criteria for this analysis.||percentage of participants|||Number
804352|NCT00997503|Secondary|Incremental Rate of Stent Thrombosis (Protocol Definition)|"Stent Thrombosis (protocol definition):
The occurrence of any of the following:
Clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis:
Angiographic documentation of acute complete occlusion (TIMI flow 0 or 1) of a previously successfully treated artery (TIMI flow 2 to 3 immediately after stent placement and diameter stenosis less than or equal to 30%) and/or Angiographic documentation of a flow limiting thrombus within or adjacent to a previously successfully treated lesion
Acute MI in the distribution of the treated vessel.
Death within the first 30 days post index procedure (without other obvious cause) is considered a surrogate for stent thrombosis when angiography is not available."|1-2 years|To be analyzed in this secondary analysis, a subject needed to have an endpoint event between 1-2 years or sufficient follow-up through 2-years. There were 448 subjects that did not meet the criteria for this analysis.||percentage of participants|||Number
804353|NCT00997503|Primary|Cardiac Death or Myocardial Infarction|Cardiac death or myocardial infarction in the TAXUS Liberte Post-Approval Study enrolled population. For pooled data from the TAXUS Liberté and TAXUS Express patient populations, please see the citations.|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.||percentage of participants|||Number
804354|NCT00997516|Secondary|Satisfaction With Physical Appearance of Abdomen and Scars at 6 Months.|"The Cosmetic Appearance Scale assessed the degree of satisfaction with the physical appearance of the abdomen (and its scars) using a visual analogue scale. Numeric scores were obtained by measuring the horizontal distance from the low end of the scale to the marking, and then normalized on a scale of 0-20 points. Higher scores indicate a higher degree of satisfaction.
Since your operation, how would you describe the overall appearance of your abdomen? (Revolting; Beautiful) Since your operation, how would you describe your incisional scars? (Revolting; Beautiful) How satisfied are you with your incisional scars? (Very unsatisfied; Very satisfied) How much discomfort do your incisional scars cause? (Severe, daily pain; No pain at all) Can you score your own incisional scar? (Worst possible scar; Best possible scar)"|6 months|Participants who returned surveys for long-term follow-up||units on a scale||Standard Deviation|Mean
804355|NCT00997516|Secondary|Body Image Score at 6 Months|"After a minimum of 6 months, a Body-Image Questionnaire was sent to participants. The questionnaire has 5 questions, with answers ranging from 1 (Extremely) to 4 (Not at all); lower scores indicate worse satisfaction with and perception of bodily appearance.
Are you less satisfied with our body since the operation? Do you think the operation has damaged your body? Do you feel less attractive as a results of your operation? Do you feel less feminine or masculine as a result of your operation? Is it difficult to look at yourself naked?"|6 months|67 of 75 patients completed and returned follow-up surveys||units on a scale||Standard Deviation|Mean
804356|NCT00997516|Secondary|Readmission Within 30 Days.|Number of participants readmitted to the hospital within 30 days of surgery|30 days|||participants|||Number
804357|NCT00997516|Secondary|Time to Return to Work|Number of calendar days between participants' discharge from the hospital and the first day back at work.|30 days|||Days||Standard Deviation|Mean
804358|NCT00997516|Secondary|Wound Seroma|Number of participants who experienced un-inflamed fluid collection under the skin incision > 1cm in diameter identified within 6 months of surgery.|6 months|||participants|||Number
804359|NCT00997516|Secondary|Deep Space Infection|Number of participants who required reoperation, readmission, or percutaneous drainage of a deep (organ space) infection within 6 months of surgery. All intra-abdominal abscesses were classified as deep space infections.|6 months|||participants|||Number
804360|NCT00997516|Secondary|Wound Infection|Number of participants who required additional antibiotics, prescribed beyond the perioperative antibiotics given for acute appendicitis, for the purpose or treating a wound cellulitis.|6 months|||participants|||Number
804361|NCT00997516|Secondary|Length of Stay|Number of calendar days the participant was hospitalized.|up to 14 days|||Days||Standard Deviation|Mean
804362|NCT00997516|Secondary|Visceral or Vascular Injury|Number of participants who required intervention (suture or stapled repair, use of hemostatic agents) for injury to the intestines, colon, omentum, vasculature, or pelvic organs during the dissection.|during surgery, up to 6 hours|||participants|||Number
804363|NCT00997516|Secondary|Procedures Requiring Conversion to Open or Additional Port|Patients requiring use of additional incisions and/or trocars, or the need to perform an open procedure.|during surgery , up to 6 hours|||participants|||Number
804364|NCT00997516|Secondary|Operative Time|The amount of time to perform the operation from skin-incision to application of the dressing. This time is routinely charted by the circulating nurse in the operating room.|up to 6 hours|||minutes||Standard Deviation|Mean
804365|NCT00997516|Primary|Pain After Surgery|Mean pain score during 12 hours post-surgery, assessed by the ward nurse as needed, but at least every 4 hours, and documented in the patient's chart. Patients were asked to rate their pain on a scale of 0 to 10, with 10 being the most severe pain imaginable and 0 being no pain at all.|12 hours post-surgery|||units on a scale||Standard Deviation|Mean
804366|NCT00997555|Secondary|Length of Hospital Stay|Number of hospital days (bronchoscopy 21 days, 95% CI +/- 12 days versus control 26 days, 95% CI +/- 12 days, p = 0.5).|until discharge from hospital, data reviewed every 6 months|||days||95% Confidence Interval|Median
815829|NCT01102374|Secondary|Severity of Acute Respiratory Infections|ARIs resulting in emergency department visits or hospitalizations|12 month|||events|||Number
804372|NCT00997594|Primary|Number of Participants With Hypertension During Adrenal or Non-adrenal Radiofrequency Ablation|Blood pressure was monitored during radiofrequency (RF) ablation. The frequency of hypertension (systolic blood pressure of more than 200 mmHg) was evaluated and compared between the adrenal and non-adrenal (RF ablation other than adrenal gland) RF ablation groups.|1 week|||participants|||Number
804373|NCT00997594|Primary|Serum Cathecholamine Levels||around one year||10/2015||||
804374|NCT00997594|Secondary|Increase in Cortisol||1 day||||||
804375|NCT00997594|Primary|Increase in Catecholamine||One day||||||
804376|NCT00997672|Secondary|Effect of Lithium on Quality of Life Will be Assessed With the EQ-5D Scale.||48 weeks||||||
804377|NCT00997672|Secondary|Effect of Lithium on Quality of Life Will be Assessed With the EQ-5D Scale.||24 weeks||||||
804378|NCT00997672|Secondary|The Effect of Lithium on Mood Will be Explored With the Beck Depression Inventory.||48 weeks||||||
804379|NCT00997672|Secondary|The Effect of Lithium on Mood Will be Explored With the Beck Depression Inventory.||24 weeks||||||
804380|NCT00997672|Secondary|Micro- and Macrostructural Magnetic Resonance Parameters Will be Compared Before and After Treatment. This Will Include Voxel Based Morphometry, Resting Functional MRI, Diffusion Tensor Imaging and MRI Spectroscopy.||48 weeks||||||
804381|NCT00997672|Secondary|Secondary Outcome Will be the Unified Multiple System Atrophy Rating Scale (UMSARS). Statistical Analysis Will be Performed to Compare the Effect of Treatment on Both Groups.||48 weeks||||||
804382|NCT00997672|Secondary|Secondary Outcome Will be the Unified Multiple System Atrophy Rating Scale (UMSARS). Statistical Analysis Will be Performed to Compare the Effect of Treatment on Both Groups.||24 weeks||||||
804383|NCT00997672|Secondary|Effect of Lithium on Quality of Life Will be Assessed With the EQ-5D Scale.||0 weeks||||||
804384|NCT00997672|Secondary|The Effect of Lithium on Mood Will be Explored With the Beck Depression Inventory.||0 weeks||||||
804385|NCT00997672|Secondary|Micro- and Macrostructural Magnetic Resonance Parameters Will be Compared Before and After Treatment. This Will Include Voxel Based Morphometry, Resting Functional MRI, Diffusion Tensor Imaging and MRI Spectroscopy.||0 weeks||||||
804386|NCT00997672|Secondary|Secondary Outcome Will be the Unified Multiple System Atrophy Rating Scale (UMSARS). Statistical Analysis Will be Performed to Compare the Effect of Treatment on Both Groups.||0 weeks||||||
804387|NCT00997672|Primary|Primary Endpoint of the Study Will be the Difference in Number and Relative Frequency of Severe Adverse Events (SAE) and Non Severe Adverse Events (nSAE) Recorded During the Study, Between Treatment and Placebo Group.|Number of Adverse Events and their relative frequency in treatment groups was analyzed|the endpoint will be recorded at all visits|||number of AEs|||Number
804388|NCT00997932|Primary|IUD Expulsion|Expulsion of the LNG-IUS|From time of insertion to final study date which is 6 months after IUD insertion.|||Participants|||Count of Participants
804389|NCT00997984|Secondary|Change From Baseline in Weight at Week 8 - LOCF||Baseline and up to 8 weeks|Safety Population||pounds||Standard Deviation|Mean
804390|NCT00997984|Secondary|Change From Baseline in Height at Week 8 - LOCF||Baseline and up to 8 weeks|Safety Population||inches||Standard Deviation|Mean
804391|NCT00997984|Secondary|Change From Baseline in Oral Temperature at Week 8 - LOCF||Baseline and up to 8 weeks|Safety Population||º F||Standard Deviation|Mean
804392|NCT00997984|Secondary|Change From Baseline in Pulse Rate at Week 8 - LOCF||Baseline and up to 8 weeks|Safety Population||beats per minute||Standard Deviation|Mean
804393|NCT00997984|Secondary|Change From Baseline in Diastolic Blood Pressure at Week 8 - LOCF||Baseline and up to 8 weeks|Safety Population||mmHg||Standard Deviation|Mean
804394|NCT00997984|Secondary|Change From Baseline in Systolic Blood Pressure at Week 8 - LOCF||Baseline and up to 8 weeks|Safety Population||mmHg||Standard Deviation|Mean
804395|NCT00997984|Secondary|Change From Baseline in Mean Weiss Functional Impairment Rating Scale – Parent Report (WFIRS-P) Global Score at Week 8 - LOCF|The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Higher scores indicate greater functional impairment. Mean scores range from 0 to 3.|Baseline and up to 8 weeks|FAS||Units on a scale||Standard Error|Least Squares Mean
804396|NCT00997984|Secondary|Post Sleep Questionnaire (PSQ) Quality of Sleep at Week 8 - LOCF|Post Sleep Questionnaire (PSQ) overall rating of quality of sleep. There are 5 rating responses ranging from very poor to very good. No numbers are associated with the rating responses.|up to 8 weeks|FAS||Percent of Participants|||Number
804397|NCT00997984|Secondary|Change From Baseline in the Bedtime Resistance Subscale of Child’s Sleep Habits Questionnaire (CSHQ) at Week 8 - LOCF|The bedtime resistance subscale of CSHQ consists of 6 items scored on a scale from 1 (never/rarely) to 3 (Usually). A higher score reflects more disturbed sleep behavior.|Baseline and up to 8 weeks|FAS||Units on a scale||Standard Error|Least Squares Mean
804398|NCT00997984|Secondary|Change From Baseline in Conner's Parent Rating Scale - Revised Short Version (CPRS-R:S) Score at Week 8 - LOCF|The Conner's Parent rating Scale-revised short version (CPRS-R) consists of 27 questions graded on a scale from 0 (not true at all) to 3 (very much true) with a total score ranging from 0 to 81. Higher scores are indicative of increased ADHD. This scale allows parents to respond on the basis of the child's behavior and help assess ADHD and evaluate problem behavior.|Baseline and up to 8 weeks|FAS||Units on a scale||Standard Error|Least Squares Mean
804399|NCT00997984|Secondary|Change From Baseline in Health Utilities Index-2/3 (HUI 2/3) Scores at Week 8 - LOCF|HUI is used to describe health status and to obtain utility scores by collecting data using one or more questionnaires in formats selected to match the specific study design criteria. Scoring ranges from 0.00 (dead) to 1.00 (perfect health). Higher scores represent better health status.|Baseline and up to 8 weeks|FAS||Units on a scale||Standard Deviation|Mean
804400|NCT00997984|Secondary|Change From Baseline in Pediatric Daytime Sleepiness Scale (PDSS) Total Score at Week 8 - LOCF|The Pediatric Daytime Sleepiness Scale (PDSS) is an 8 question questionnaire scored on a scale from 0 (never) to 4 (always). Total scores range from 0 to 32, with increasing score reflecting greater sleepiness.|Baseline and up to 8 weeks|Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.||Units on a scale||Standard Error|Least Squares Mean
805728|NCT01005719|Secondary|Median 24-hr Intragastric pH on Day 7|The median intragastric pH values were recorded over a 24-hr period.|Treatment dose to 24-hour post-dose on Day 7|Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.||pH||Full Range|Median
804401|NCT00997984|Secondary|Improvement on Clinical Global Impression-Improvement (CGI-I) Scale at Week 8 - LOCF|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement includes a score of 1 (very much improved) or 2 (much improved) on the scale.|up to 8 weeks|FAS||Percent of Participants|||Number
804402|NCT00997984|Secondary|Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|Baseline and up to 8 weeks|FAS||Percent of Participants|||Number
804403|NCT00997984|Primary|Change From Baseline in Attention-Deficit/Hyperactivity Disorder-Rating Scale-IV (ADHD-RS-IV) Total Score at Week 8 - Last Observation Carried Forward (LOCF)|The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|Baseline and up to 8 weeks|Full Analysis Set (FAS) defined as all subjects who had taken at least 1 dose of investigational product during the study.||Units on a scale||Standard Error|Least Squares Mean
804404|NCT00998023|Secondary|Major Complications|Number of participants with permanent access site-related nerve injury, access-site related surgical/vascular repair, amputation related to access closure complication, access site-related bleeding/hematoma requiring transfusion, any new ipsilateral lower extremity ischemia requiring non-surgical intervention, local access site-related or generalized infection requiring prolonged hospitalization or re-hospitalization and treatment with IV antibiotics or inflammatory reaction that may include local signs and drainage, treated with re-hospitalization, IV antibiotics and/or surgical intervention|1 Day|Per protocol||Participants|||Number
804405|NCT00998023|Primary|Mean Score on the Visual Analogue Scale|The Visual Analogue Scale measures the severity of pain on a continuous scale from 0 (no pain) to 10 (worst possible pain).|Immediately before vascular closure and immediately after vascular closure.|Per protocol||Scores on a Scale||Standard Error|Mean
804406|NCT00998049|Secondary|Rate of Failure to Mobilize|The rate of failure to mobilize will be estimated by dividing the number of patients that fail to mobilize by the total number of evaluable patients. A patient is considered a failure if they never achieve 2.5 million CD34 cells/kg.|Duration of apheresis (up to 7 days)|||percentage of participants||95% Confidence Interval|Number
804407|NCT00998049|Secondary|Time to Reach 6 Million CD34 Cells|Number (median and 95% confidence interval) of days to reach 6 million CD34 cells/kg was estimated using the Kaplan Meier method. Participants were lower than 6 million CD34 cells/kg at time of last follow-up will be censored at that date.|Duration of apheresis (up to 7 days)|||days||95% Confidence Interval|Median
804408|NCT00998049|Secondary|Median Number of Days of Apheresis||Duration of apheresis (up to 7 days)|||days||Full Range|Median
804409|NCT00998049|Secondary|CD34 Yield Day 2|Number of CD34 cells/kg collected on day 2|Day 2|||cells/kg||Full Range|Median
804410|NCT00998049|Secondary|CD34 Yield on Day 1|Number of CD34 cells/kg collected on day 1.|Day 1|||cells/kg||Full Range|Median
804411|NCT00998049|Primary|Number of Patients Achieving 3 Million CD34 Cells/kg After 2 Days of Apheresis|"Number of CD34 cells/kg collected on days 1-2.
Apheresis is the process when blood is taken out through a catheter in a vein in one arm, blood is sent through a machine that takes out the stem cells and the rest of the blood is then returned through a vein in your other arm."|After 2 days of apheresis|||participants|||Number
804412|NCT00998205|Secondary|Change in Early Transmitral Velocity/Early Lateral Mitral Velocity (E/E')|Echocardiography was performed at rest and with dobutamine stress at 3 minutes, 6 minutes, 9 minutes, and 12 minutes, to measure differences in E/E' at the septum and lateral mitral annulus. Change from baseline at recovery reported.|Baseline, recovery|||Ratio||Full Range|Mean
804413|NCT00998205|Primary|Change in Left Ventricle Mean Diastolic Pressure|Left ventricle filling pressures were measured using a pigtail catheter inserted into the left ventricle. Measurements of left ventricle pressures were taken at baseline, 3 minutes, 6 minutes, 9 minutes, 12 minutes, and recovery. Change from baseline at recovery reported.|Baseline, recovery|||mmHg||Full Range|Mean
804414|NCT00998296|Secondary|Percentage Change in the Tumour Size From Baseline During the Expansion Phase|Percentage change in the tumour size from baseline is expressed as Number of subjects with maximum decrease from baseline in the sum of longest diameters of target lesions.|Tumour assessment was to be performed at Screening, every 6 weeks after starting study treatment until disease progression, and at the end-of-treatment (EOT) visit (up to 1117 days)|Treated set||participants|||Number
804415|NCT00998296|Secondary|Stable Disease for at Least 12 Weeks During the Expansion Phase|"SD: Neither sufficient shrinkage to qualify for PR (Partial response) nor sufficient increase to qualify for PD(Progressive disease), taking as references the smallest sum of diameters SoD while on study.
PR: At least a 30% decrease in the sum of diameters (SoD) of target lesions taking as reference the baseline sum diameters.
PD: At least a 20% increase in the SoD of target lesions, taking as references the smallest sum on study (this includes the baseline sum if that is the smallest on study). Also, the sum must also demonstrate an absolute increase of a least 5mm. Appearance of one or more new lesions."|Tumour assessment was to be performed at Screening, every 6 weeks after starting study treatment until disease progression, and at the end-of-treatment (EOT) visit (up to 1117 days)|Treated set||percentage of participants|||Number
804416|NCT00998296|Secondary|Disease Control (DC) During the Expansion Phase|DC is defined as the best overall response of CR, PR, stable disease (SD) and non-CR/non-PD. CR for target lesions (TL): Disappearance of all target lesions. CR for non-target lesions (NTL): Disappearance of all non-target lesions . All lymph nodes must be non-pathological in size (<10mm short axis). PR for TL: At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. Other factors which add to the overall response of an imaging timepoint as PR are as below:- CR in TL, but non-CR/Non-PD in NTL leads to PR CR in TL, but not evaluated NTL leads to PR PR in TL, but non-PD NTL or not all evaluated NTL leads to PR; SD for TL: change in the sum of diameters does not satisfy PR or PD. SD in TL, non-PD in NTL lead to overall response of SD, provided there is no appearance of new lesions.|Tumour assessment was to be performed at Screening, every 6 weeks after starting study treatment until disease progression, and at the end-of-treatment (EOT) visit (up to 1117 days)|Treated set||percentage of participants|||Number
804543|NCT00985829|Secondary|Histologic Resolution of Lesion|disappearance of the lesion in histologic examination|immediately after the terminaton of treatment course (with an average of 5 months after initiation of PDT)|from those 9 lesions with clinically complete reponse , 3 lesions were biopsied and assessed histologically.||lesions|||Number
804417|NCT00998296|Secondary|Objective Response (OR) During the Expansion Phase|"OR is defined as a best overall response of complete response (CR) or partial response (PR) according to RECIST version 1.1, CR for target lesions (TL): Disappearance of all target lesions.
CR for non-target lesions (NTL): Disappearance of all non-target lesions. All lymph nodes must be nonpathological in size (<10mm short axis). PR for TL: At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters.
Other factors which add to the overall response of an imaging timepoint as PR are as below:
CR in TL, but non-CR/Non-PD in NTL leads to PR CR in TL, but not evaluated NTL leads to PR PR in TL, but non-PD NTL or not all evaluated NTL leads to PR; All the above scenarios should also satisfy 'No occurrence of new lesions'."|Tumour assessment was to be performed at Screening, every 6 weeks after starting study treatment until disease progression, and at the end-of-treatment (EOT) visit (up to 1117 days)|Treated set||percentage of participants|||Number
804418|NCT00998296|Secondary|Trough Plasma Concentration of Afatinib at Steady State|"C(pre,ss) is defined as pre-dose (trough) concentration of afatinib in plasma at steady state immediately before administration of the next dose.
C24,7 corresponds to the plasma concentration at 24 hours on Day 7. C24,13 corresponds to the plasma concentration at 24 hours on Day 13. C24,27 corresponds to the plasma concentration at 24 hours on Day 27."|Day 7, Day 13, Day 15, Day 22, Day 27 and Day 28|"PKS. Only 6 patients were planned to be treated in the Nintedanib 150 mg +Afatinib 30 mg- Continuously group. Nevertheless, the patients were allowed to reduce their dose and by the way they changed the group and came in the Nintedanib 150 mg +Afatinib 30 mg- Continuously group with at the end N = 8 evaluable concentrations instead of 6 planned"||nanogram/millilitre (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
804419|NCT00998296|Secondary|Cpre,ss,Norm (Dose Normalized Trough Plasma Concentration of Nintedanib at Steady State)|"Cpre,ss,norm (Dose normalized trough plasma concentration of nintedanib at steady state) are presented for the 2 MTD treatment groups (continuous administered nintedanib at 150 mg b.i.d. concomitantly with continuously administered afatinib 30 mg q.d. or with intermittently administered afatinib 40 mg q.d.)
As nintedanib is given twice daily, samples are taken at Day 8, Day 15, Day 22 and Day 28; the Pharmacokinetic (PK) parameter names will be Cpre,ss,15,norm (Day 8), Cpre,ss,29,norm (Day 15), Cpre,ss,43,norm (Day 22) and Cpre,ss,55,norm (Day 28)"|Day 8, Day 15, Day 22 and Day 28|"PKS. Only 6 patients were planned to be treated in the Nintedanib 150 mg +Afatinib 30 mg- Continuously group. Nevertheless, the patients were allowed to reduce their dose and by the way they changed the group and came in the Nintedanib 150 mg +Afatinib 30 mg- Continuously group with at the end N = 8 evaluable concentrations instead of 6 planned"||nanogram/millilitre/milligram (ng/mL/mg)||Geometric Coefficient of Variation|Geometric Mean
804420|NCT00998296|Secondary|Changes in Safety Laboratory Parameters|Changes in safety laboratory Parameters reported as adverse events|First treatment administration until cut-off date of 02 October 2014, up to 336 days|TS||participants|||Number
804421|NCT00998296|Secondary|Incidence and Intensity of Adverse Events According to CTCAE (Common Toxicity Criteria Adverse Event) Version 3.0|Incidence and intensity of Adverse Events with grading according to the Common Terminology Criteria for Adverse Events (CTCAE version 3.0).|First treatment administration until cut-off date of 02Oct2014; up to 336 days|TS||participants|||Number
804422|NCT00998296|Secondary|Overall Tumour Response Rate Assessed by the Investigator According to the Response Evaluation Criteria In Solid Tumours (RECIST) Version 1.1|"The investigator evaluated whether complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD) occurred in a patient.
CR for target lesions: Disappearance of all target lesions. CR for non-target lesions: Disappearance of all non-target lesions and normalization of tumour marker level. All lymph nodes must be non-pathological in size (<10mm short axis).
PR: At least a 30% decrease in the sum of diameters (SoD) of target lesions taking as reference the baseline sum diameters.
SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as references the smallest SoD while on study.
PD: At least a 20% increase in the SoD of target lesions, taking as references the smallest sum on study (this includes the baseline sum if that is the smallest on study). Also, the sum must also demonstrate an absolute increase of a least 5mm. Appearance of one or more new lesions"|6 weeks|TS||percentage of participants|||Number
804423|NCT00998296|Primary|Maximum Tolerated Dose (MTD) of Nintedanib and Afatinib Based on the Percentage of Participants Experienced Dose Limiting Toxicities|Maximum tolerated dose (MTD) of nintedanib and afatinib based on the Percentage of participants experienced dose limiting toxicities during the dose escalation phase.|first treatment cycle, up to 28 days|TS||percentage of participants|||Number
804424|NCT00998309|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Pregnancy in Female|Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without Pregnancy in Female is significant risk factor.|Baseline to 29 days|The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed.||participants|||Number
804425|NCT00998309|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Non-Drug Therapy|Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without non-drug therapy is significant risk factor.|Baseline to 29 days|The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed.||participants|||Number
804426|NCT00998309|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Comcomittant Drugs|Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without comcomittant drugs is significant risk factor.|Baseline to 29 days|The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed.||participants|||Number
804427|NCT00998309|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Previous Antibiotic Treatment History (PATH)|Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without previous antibioutic treatment history (PATH) is significant risk factor.|Baseline to 29 days|The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed.||participants|||Number
808349|NCT01033448|Primary|End of Treatment Response Rate at Week 72 in Genotype 1|End of treatment response rate at Week 72 was reported for genotype 1.|Week 72|Participants with genotype 1 CHC at Week 72.||Percentage of Participants|||Number
804428|NCT00998309|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Complications|Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without complications is significant risk factor.|Baseline to 29 days|The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed.||participants|||Number
804429|NCT00998309|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Past Medical History|Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without Past Medical History is significant risk factor.|Baseline to 29 days|The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed.||participants|||Number
804430|NCT00998309|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Renal Dysfunction|Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without Renal Dysfunction is significant risk factor.|Baseline to 29 days|The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed.||participants|||Number
804431|NCT00998309|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Hepatic Dysfunction|Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without Hepatic Dysfunction is significant risk factor.|Baseline to 29 days|The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed.||participants|||Number
804432|NCT00998309|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Infection Severity|Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether mild infection, moderate infection, or severe infection is significant risk factor.|Baseline to 29 days|The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed.||participants|||Number
804433|NCT00998309|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Type of Infection|"Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether Type of Infection, Skin and Soft Tissue Infection, Sexual Transmitted Infection, or Dental, or Oral Surgery Infection, is significant risk factor."|Baseline to 29 days|The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed.||participants|||Number
804434|NCT00998309|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Age|Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether <65 years or >=65 years is significant risk factor.|Baseline to 29 days|The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed.||participants|||Number
804435|NCT00998309|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Gender|Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether male or female is significant risk factor.|Baseline to 29 days|The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed.||participants|||Number
804436|NCT00998309|Primary|Number of Unlisted Treatment Related Adverse Events (TRAEs)|All observed or volunteered adverse events and the investigator’s opinion of the causal relationship to the study treatment were reported. Defenition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert.|Baseline to 29 days|The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed.||Events|||Number
804437|NCT00998309|Primary|Number of Participants With Treatment Related Adverse Events (TRAEs)|All observed or volunteered adverse events and the investigator’s opinion of the causal relationship to the study treatment were reported. Defenition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product.|Baseline to 29 days|The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed.||participants|||Number
804438|NCT00998309|Secondary|Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Non-Drug Therapy|Number of participants with responders of azithromycin to determine whether with or without non-drug therapy is significant risk factor.|Baseline to 29 days|The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
804439|NCT00998309|Secondary|Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Comcomittant Drugs(CD)|Number of participants with responders of azithromycin to determine whether with or without comcomittant drugs is significant risk factor.|Baseline to 29 days|The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
804440|NCT00998309|Secondary|Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Previous Antibiotic Treatment History (PATH)|Number of participants with responders of azithromycin to determine whether with or without previous antibiotic treatment history is significant risk factor.|Baseline to 29 days|The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
804441|NCT00998309|Secondary|Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Complications|Number of participants with responders of azithromycin to determine whether with or without complications is significant risk factor.|Baseline to 29 days|The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
804442|NCT00998309|Secondary|Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Past Medical History (PMH)|Number of participants with responders of azithromycin to determine whether with or without past medical history is significant risk factor.|Baseline to 29 days|The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
804443|NCT00998309|Secondary|Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Renal Dysfunction(RD)|Number of participants with responders of azithromycin to determine whether with or without renal dysfunction is significant risk factor.|Baseline to 29 days|The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
804444|NCT00998309|Secondary|Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Hepatic Dysfunction(HD)|Number of participants with responders of azithromycin to determine whether with or without hepatic dysfunction is significant risk factor.|Baseline to 29 days|The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
804445|NCT00998309|Secondary|Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Infection Severity|"Number of participants with responders of azithromycin to determine whether Infection severity, mild infection, moderate infection, or severe infection, is significant risk factor."|Baseline to 29 days|The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
804446|NCT00998309|Secondary|Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Type of Infection|"Number of participants with responders of azithromycin to determine whether type of infection, Skin and Soft Tissue Infection, Sexual Transmitted Infection, or Dental and Oral Surgery Infection, is significant risk factor."|Baseline to 29 days|The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
804447|NCT00998309|Secondary|Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Age|Number of participants with responders of azithromycin to determine whether <65 years or >=65 years is significant risk factor.|Baseline to 29 days|The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
804448|NCT00998309|Secondary|Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Gender|Number of participants with responders of azithromycin to determine whether male or female is significant risk factor.|Baseline to 29 days|The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
804449|NCT00998309|Primary|Number of Participants With an Investigator’s Assessment of Clinical Outcome (Effective (Cured)/ Not Effective (Not Cured)) at End of the Study.|The physician in charge of the survey performed comprehensive clinical effect evaluation on result of clinical findings, bacteriological effect and others. Clinical effect (Effective (cured)/ Not effective (not cured)/ unable to evaluate effectiveness evaluation) was performed at visits during the observation period by comparing to the data before administration of this drug.Criteria of cured was disappearance or improvement of clinical findings with infections and/or causal bacterial disappearance.|Baseline to 29 days|The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
804450|NCT00998335|Secondary|Percent Change From Baseline in Vascular Inflammatory Markers|Inflammatory Markers include: Adiponectin, MMP-9, E-selectin, sICAM, and sVCAM|3 and 6 months|||Percentage of change||Standard Deviation|Mean
804451|NCT00998335|Secondary|Change in Anthropometric Measure (Body Mass Index [BMI]).|Change in anthropometric measure (body mass index [BMI]) done on day of admission at 3 and 6 months.|3 and 6 months.|"All participants were started in the Insulin detemir only arm. At week 12 the participants were randomized in a 2:1 ratio between the two arms. N=30 for first 3 months and N=28 for 6 months"||Change from baseline (Kg/m2)||Standard Deviation|Mean
804452|NCT00998335|Secondary|Advanced Lipid Testing|Change in lipoprotein particle number was determined using NMR.|3 and 6 months|||Change in number of particles (nmol/L)||Standard Deviation|Mean
804453|NCT00998335|Secondary|Metabolic Control as Measured by the Postprandial Plasma Glucose During the Day-long Plasma Glucose Profile.||3 and 6 months|"All participants were started in the Insulin detemir only arm. At week 12 the participants were randomized in a 2:1 ratio between the two arms. N=30 for first 3 months and N=28 for 6 months"||mg/dL||Standard Deviation|Mean
804454|NCT00998335|Secondary|Metabolic Control as Measured by the Fasting Plasma Glucose Concentration||3 and 6 months|"All participants were started in the Insulin detemir only arm. At week 12 the participants were randomized in a 2:1 ratio between the two arms. N=30 for first 3 months and N=28 for 6 months"||mg/dL||Standard Deviation|Mean
804455|NCT00998335|Secondary|Number of Hypoglycemic Events|Defined as hypoglycemia <40 mg/dl and/or requiring medical assistance during the trial.|3 and 6 months|"All participants were started in the Insulin detemir only arm. At week 12 the participants were randomized in a 2:1 ratio between the two arms. N=30 for first 3 months and N=28 for 6 months"||Number of events|||Number
804456|NCT00998335|Secondary|Change in Anthropometric Measure (Body Weight).|Change in anthropometric measure (body weight) done on day of admission at 3 and 6 months.|3 and 6 months.|"All participants were started in the Insulin detemir only arm. At week 12 the participants were randomized in a 2:1 ratio between the two arms. N=30 for first 3 months and N=28 for 6 months"||Change from baseline (Kg)||Standard Deviation|Mean
804457|NCT00998335|Secondary|Plasma Lipid Concentration.|Fasting plasma lipid concentration on day of admission at 3 and 6 months.|3 and 6 months.|"All participants were started in the Insulin detemir only arm. At week 12 the participants were randomized in a 2:1 ratio between the two arms. N=30 for first 3 months and N=28 for 6 months"||mg/dL||Standard Deviation|Mean
805729|NCT01005719|Secondary|Percentage Time Intragastric pH >4 During the First 4 Hours After Dosing on Day 7||Treatment dose to 4 hours Post-dose on Day 7|Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.||Percentage of time||Full Range|Median
804458|NCT00998335|Secondary|Intramyocellular (IMCL) by Magnetic Resonance Imaging and Spectroscopy (MRS).|Percent intramyocellular (IMCL) by magnetic resonance imaging and spectroscopy (MRS).|3 and 6 months.|"All participants were started in the Insulin detemir only arm. At week 12 the participants were randomized in a 2:1 ratio between the two arms. N=30 for first 3 months and N=28 for 6 months"||% of intramyocellular triglyceride||Standard Deviation|Mean
804459|NCT00998335|Secondary|Change in Insulin Secretion|Derived from the hyperglycemic clamp (Plasma C-peptide change vs. pretreatment in first and second phase).|3 and 6 months.|"All participants were started in the Insulin detemir only arm. At week 12 the participants were randomized in a 2:1 ratio between the two arms. N=30 at 3 months and N=28 at 6 months."||ng/ml||Standard Deviation|Mean
804460|NCT00998335|Secondary|Metabolic Control as Measured by the A1c||3 and 6 months|"All participants were started in the Insulin detemir only arm. At week 12 the participants were randomized in a 2:1 ratio between the two arms."||percentage of A1c||Standard Deviation|Mean
804461|NCT00998335|Primary|Hepatic Steatosis|Hepatic steatosis measured by proton magnetic resonance spectroscopy (1H-MRS).|3 and 6 months|In six patients liver MRS was not possible due to claustrophobia, metal parts, or too large for MRI scanner. N=30 participants in the Insulin detemir x 3 months, N=8 participants in the Insulin Detemir alone and 22 in the Detemir Plus Aspart at 6 months.||percentage of liver fat||Standard Deviation|Mean
804462|NCT00998374|Primary|Reactive Hypoglycemia Status|"Postoperative reactive hypoglycemia was defined as either
serum glucose <60 mg/dL at least 1 hour after initiation of glucose tolerance testing
serum glucose decrease ≥100 mg/dL within 1 hour after initiation of glucose tolerance testing"|6 months, 9 months, 12 months post-op|||participants|||Number
804463|NCT00998374|Secondary|Subjective Symptoms of Hypoglycemia During Glucose Tolerance Testing|Subjective symptoms of hypoglycemia during glucose tolerance testing measured by patients’ responses to a questionnaire about symptoms of Weakness, Nausea, Hunger, Headache, Dizziness, Diaphoresis graded on a yes/no response|6, 9, and 12 months post-op|||participants|||Number
804464|NCT00998374|Secondary|Insulin Resistance|Measured by levels of post prandial insulin|6, 9, and 12 months post-operatively|||pmol/L||Standard Deviation|Mean
804465|NCT00998374|Primary|Mean Serum Glucose Levels|Serum glucose levels measured to assess reactive hypoglycemia status|30, 60, and 120 minutes at 6, 9, and 12 months post-operatively|||mg/dl||Standard Deviation|Mean
804466|NCT00998426|Primary|Differences in Blood Glucose Levels as Measured by GNS-POC, GS-POC and Venous Blood Prior to and After HBIG Injection|All participants received GNS-POC, GS-POC and venous blood glucose measurements prior to and after HBIG injection( immediately following, 60 and 120 min post dose).|Pre-dose, immediately following, 60 min and 120 min after injection|||mg/dL||Standard Deviation|Mean
804467|NCT00998517|Secondary|Rates of Gain in Mid-upper Arm Circumference, and Length|These rates will be measured up to the 2nd followup visit (4 weeks) or up to the 1st followup visit (2 weeks) if the child recovered after only 2 weeks|4 weeks|||mm/d||Standard Deviation|Mean
804468|NCT00998517|Secondary|Remain Well-nourished Through 12 Months Following Successful Treatment for Moderate Acute Malnutrition (MAM)|Children who were successfully treated for MAM in the primary portion of the study were followed prospectively with scheduled follow-up visits for 12 months to evaluate whether they remained well-nourished, defined as mid-upper arm circumference (MUAC) >= 12.5 cm or weight-for-height Z-score >= -2 throughout the duration of follow-up.|12 months|Children who successfully recovered from MAM following the standard treat-to-WHZ -2 protocol.||participants|||Number
804469|NCT00998517|Secondary|Number of Patients With Fever, Cough, and Diarrhea During the First Two Weeks of Treatment||2 weeks|||participants|||Number
804470|NCT00998517|Secondary|Number of Patients With Adverse Outcomes|This includes children with allergic or other adverse reactions that could be attributed to their assigned intervention food.|12 months|||participants|||Number
804471|NCT00998517|Secondary|Rate of Weight Gain|This rate will be measured up to the 2nd followup visit (4 weeks) or up to the 1st followup visit (2 weeks) if the child recovered after only 2 weeks|4 weeks|||g/kg/d||Standard Deviation|Mean
804472|NCT00998517|Primary|Number of Patients With Absence of Bilateral Pedal Pitting Edema||12 weeks or recovery|||participants|||Number
804473|NCT00998517|Primary|Number of Participants With Nutritional Recovery|"Recovery is defined by weight for height Z (WHZ) score of -2 or greater using enrollment length.
WHZ will be computed using standard WHO growth standards: http://www.who.int/childgrowth/standards/en/"|12 weeks or upon completion of recovery|||participants|||Number
804474|NCT00998582|Primary|Outcome Was Change in Large Artery Elasticity (mL/mmHg x100) From Baseline to Week 24|Large artery elasticity is a measure of vascular function, estimated through analysis of the blood pressure waveform. A sensor is placed on wrist over the radial pulse. The blood pressure waveform of the pulse is recorded and analyzed the elasticity, or compliance, of the large (and small) vasculature. Impaired artery elasticity, or increased stiffness, is an early sign of vascular disease.|Change from baseline to 24 weeks|Large artery elasticity was measured at baseline and week 24 in all participants. Outcome was change in large artery elasticity (mL/mmHg x10) from baseline to week 24||ml/mmHg x10||Inter-Quartile Range|Median
804475|NCT00998582|Primary|Change in Small Artery Elasticity (mL/mmHg x100) From Baseline to Week 24|Small artery elasticity is a measure of vascular function, estimated through analysis of the blood pressure waveform. A sensor is placed on wrist over the radial pulse. The blood pressure waveform of the pulse is recorded and analyzed the elasticity, or compliance, of the small (and large) vasculature. Impaired artery elasticity, or increased stiffness, is an early sign of vascular disease that predicts risk for future cardiovascular events.|Change from baseline to 24 weeks|Small artery elasticity was measured at baseline and week 24 in all participants. Outcome was change in small artery elasticity (mL/mmHg x100) from baseline to week 24||ml/mmHg x100||Inter-Quartile Range|Median
804504|NCT00998985|Secondary|Maximum log10 HCV RNA Reduction From Baseline Following Administration of Grazoprevir in Participants With GT1 HCV or Pooled GT1 and GT3 HCV Participants Treated With Placebo|Blood samples were collected at baseline and at intervals up to 2 months post-dose in order to determine the maximum log10 reduction from baseline in plasma HCV RNA, expressed in international units (IU)/mL.|Baseline and up to approximately 2 months|Participants who complied with the protocol sufficiently to ensure that these data will exhibit the effects of treatment, according to the underlying scientific model. One GT1 participant treated with 50 mg grazoprevir, who discontinued, and all GT3 participants treated with grazoprevir were excluded from analysis.||log10 IU/mL||95% Confidence Interval|Least Squares Mean
804476|NCT00998660|Primary|Identify the Rate of User-related Battery Depletion Adverse Events Per Subject-month Requiring Intervention by a Health Care Professional (HCP) and/or the HCP's Designee, Within the First 3 Months of the Activa RC System Being Turned ON.|Subject-months of follow-up were defined as the time from device activation to the earlier of a subject's 3-month visit or until the subject exited from the study. Any user-related battery depletion adverse events requiring intervention by a health care professional (HCP) and/or the HCP's designee were collected. The event rate per 100 subject-months of follow-up is defined as the number of user-related battery depletion events divided by the total subject follow-up months through the 3-month visit, all multiplied by 100.|3 months|The 93 implanted subjects accumulated 283.6 subject-months of follow-up through the 3-month visit. There were no reported user-related battery depletion adverse events that required an intervention by a health care professional and/or HCP designee.||Event rate per 100 subject-months||95% Confidence Interval|Number
804477|NCT00998738|Secondary|Association Between the Ixabepilone-APS and Eventual Chemotherapy-induced Neuropathy|Correlation coefficients will be produced relating the worst pain scores in the first cycle of therapy and the subsequent neuropathy scores as judged from the daily and weekly questions.|First cycle of therapy (up to 21 days)|Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.|||||
804478|NCT00998738|Secondary|Severity of the Acute Pain Syndrome (APS)|"APS was measured using the pain item which evaluated the aches/pains at its WORST in the last 24 hours in the scale of 0 to 10, with 0=no aches/pain and 10=aches/pains as bad as can be.
The outcome measures for each subsequent cycle will be analyzed in a similar fashion."|Treatment initiation to day 21 (Cycle 1)|Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.|||||
804479|NCT00998738|Secondary|Incidence of the Acute Pain Syndrome (APS)|"APS was measured using the pain item which evaluated the aches/pains at its WORST in the last 24 hours in the scale of 0 to 10, with 0=no aches/pain and 10=aches/pains as bad as can be.
The outcome measures for each subsequent cycle will be analyzed in a similar fashion."|Treatment initiation to day 21 (Cycle 1)|Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.|||||
804480|NCT00998738|Secondary|Toxicity Profile of CaMg Per CTCAE Active Version||Up to 12 months from initiation of ixabepilone|Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.|||||
804481|NCT00998738|Secondary|Average Cumulative Ixabepilone Dose||Up to 12 months from initiation of ixabepilone|Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.|||||
804482|NCT00998738|Secondary|Proportion of Patients Undergoing Dose Reduction or Discontinuing Ixabepilone Secondary to Peripheral Neuropathy||Up to 12 months from initiation of ixabepilone|Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.|||||
804483|NCT00998738|Secondary|Time to Onset of Grade 2+ and/or Grade 3+ Neurotoxicity as Assessed by NCI CTCAE Active Version|Time to onset of grade 2+ neurotoxicity was defined as time from randomization to the first occurrence of grade 2+ neurotoxicity. Time to onset of grade 3+ neurotoxicity was defined as time from randomization to the first occurrence of grade 3+ neurotoxicity.|Up to 12 months from initiation of ixabepilone|Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.|||||
804484|NCT00998738|Secondary|Percentage of Patients With Grade 2+ and/or Grade 3+ Neurotoxicity as Measured by NCI CTCAE Active Version Neuropathy Scale||Up to 12 months from initiation of ixabepilone|Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.|||||
804485|NCT00998738|Primary|Comparison of Chemotherapy-induced Peripheral Neuropathy Between Calcium With Magnesium (CaMg) and Placebo Arms, as Measured by the Sensory Subscale of EORTC QLQ-CIPN20|European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy Module (EORTC QLQ-CIPN20) sensor subscale score was calculated following the standard scoring algorithm and was transformed to a 0 to 100 scale with 0=Low QOL and 100=Best QOL for data analysis.|During the first 18 weeks of ixabepilone-based therapy|Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.|||||
804486|NCT00998764|Secondary|Change From Extension Study Baseline in MMSE Score at Weeks 6, 19, 32, 45 and 78.|MMSE measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. The MMSE total score can range from 0 to 30, with lower scores indicating a greater degree of impairment. A positive change indicates improvement from baseline.|Base Study Baseline, Weeks 6, 19, 32, 45 and 78|The Modified Intent-to-Treat (mITT) Population was defined as all randomly assigned participants who received investigational product in the base study, had a baseline for the base study, had at least one valid post-baseline assessment of the ADAS-Cog and DAD total score in the base study and signed informed consent in the extension study.||Units on a scale||Standard Error|Least Squares Mean
804487|NCT00998764|Secondary|Change From Base Study Baseline in Mini-mental State Examination (MMSE) Score at Weeks 6, 19, 32, 45 and 78.|MMSE measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. The MMSE total score can range from 0 to 30, with lower scores indicating a greater degree of impairment. A positive change indicates improvement from baseline.|Base Study Baseline, Weeks 6, 19, 32, 45 and 78|The Modified Intent-to-Treat (mITT) Population was defined as all randomly assigned participants who received investigational product in the base study, had a baseline for the base study, had at least one valid post-baseline assessment of the ADAS-Cog and DAD total score in the base study and signed informed consent in the extension study.||Units on a scale||Standard Error|Least Squares Mean
804505|NCT00998985|Secondary|24 Hour Plasma Concentration (C[24hr]) of Grazoprevir on Day 7|Blood samples were collected on Day 7 at 24 hours post-dose in order to determine the C24hr of Grazoprevir. It is hypothesized that the Geometric Mean of Day 7 Grazoprevir C24hr exceeds 28 nM.|Day 7 at 24 hours post-dose|Participants who complied with the protocol sufficiently to ensure that these data will exhibit the effects of treatment, according to the underlying scientific model. GT1 or GT3 participants who received the same treatment were combined into a single arm. Participants with placebo were not analyzed as they did not receive grazoprevir.||nM||90% Confidence Interval|Geometric Mean
806241|NCT01012167|Secondary|Side Effect Checklist (SEC) - Hypersalivation|"Percentage of participants with new onset or worsening compared to baseline of Hypersalivation rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.||percentage of participants|||Number
804488|NCT00998764|Secondary|Change From Extension Study Baseline in NPI Score at Weeks 26, 52 and 78.|NPI:12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/ aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/ indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, nighttime behavior. Severity(1=Mild to 3=Severe),frequency (1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score(range 0-12). The NPI total score ranges from 0 to 144 with higher NPI scores indicate greater impairment. A negative change indicates improvement from baseline.|Base Study Baseline, Weeks 26, 52 and 78|The Modified Intent-to-Treat (mITT) Population was defined as all randomly assigned participants who received investigational product in the base study, had a baseline for the base study, had at least one valid post-baseline assessment of the ADAS-Cog and DAD total score in the base study and signed informed consent in the extension study.||Units on a scale||Standard Error|Least Squares Mean
804489|NCT00998764|Secondary|Change From Base Study Baseline in Neuropsychiatric Inventory (NPI) Score at Weeks 26, 52 and 78.|NPI:12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/ aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/ indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, nighttime behavior. Severity(1=Mild to 3=Severe),frequency (1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score(range 0-12). The NPI total score ranges from 0 to 144 with higher NPI scores indicate greater impairment. A negative change indicates improvement from baseline.|Base Study Baseline, Weeks 26, 52 and 78|The Modified Intent-to-Treat (mITT) Population was defined as all randomly assigned participants who received investigational product in the base study, had a baseline for the base study, had at least one valid post-baseline assessment of the ADAS-Cog and DAD total score in the base study and signed informed consent in the extension study.||Units on a scale||Standard Error|Least Squares Mean
804490|NCT00998764|Secondary|Change From Extension Study Baseline in Disability Assessment for Dementia (DAD) Score at Weeks 13, 26, 39, 52 and 78.|The DAD measures instrumental and basic activities of daily living in AD participants. The DAD is administered to the participant’s caregiver in the form of an interview. The performance of basic activities of daily living is evaluated in 10 aspects including hygiene, dressing, continence, eating, meal preparation, telephoning, going on an outing, finance and correspondence, medications, leisure, and housework. The caregiver answers 40 questions as yes, no, or not applicable. A one-point score was assigned to each question if the answer is “yes” and a zero score was assigned if the answer is “no”. For questions answered as “not applicable”, no score will be assigned. The DAD total score was calculated as the total number of questions answered as “yes” divided by the total number of questions answered as “yes” or “no”, times 100. The DAD score can range from 0 to 100, with higher scores indicating better function. A positive change indicates improvement from baseline.|Base Study Baseline, Weeks 13, 26, 39, 52 and 78|The Modified Intent-to-Treat (mITT) Population was defined as all randomly assigned participants who received investigational product in the base study, had a baseline for the base study, had at least one valid post-baseline assessment of the ADAS-Cog and DAD total score in the base study and signed informed consent in the extension study.||Units on scale||Standard Error|Least Squares Mean
804491|NCT00998764|Secondary|Change From Base Study Baseline in Disability Assessment for Dementia (DAD) Score at Weeks 13, 26, 39, 52 and 78.|The DAD measures instrumental and basic activities of daily living in AD participants. The DAD is administered to the participant’s caregiver in the form of an interview. The performance of basic activities of daily living is evaluated in 10 aspects including hygiene, dressing, continence, eating, meal preparation, telephoning, going on an outing, finance and correspondence, medications, leisure, and housework. The caregiver answers 40 questions as yes, no, or not applicable. A one-point score was assigned to each question if the answer is “yes” and a zero score was assigned if the answer is “no”. For questions answered as “not applicable”, no score will be assigned. The DAD total score was calculated as the total number of questions answered as “yes” divided by the total number of questions answered as “yes” or “no”, times 100. The DAD score can range from 0 to 100, with higher scores indicating better function. A positive change indicates improvement from baseline.|Base Study Baseline, Weeks 13, 26, 39, 52 and 78|The Modified Intent-to-Treat (mITT) Population was defined as all randomly assigned participants who received investigational product in the base study, had a baseline for the base study, had at least one valid post-baseline assessment of the ADAS-Cog and DAD total score in the base study and signed informed consent in the extension study.||Units on a scale||Standard Error|Least Squares Mean
804492|NCT00998764|Secondary|Change From Extension Study Baseline in ADAS-Cog/11 at Weeks 13, 26, 39, 52 and 78.|The ADAS-Cog is a multi-item, objective measure of cognitive function. The scale evaluates memory, language, and praxis with items such as orientation, word recall, word recognition, object identification, comprehension, and the completion of simple tasks. Analysis of the ADAS-Cog for this study was based upon an 11 item score from the following items 1) word recall task, 2) naming objects and fingers, 3) following commands, 4)constructional praxis, 5) ideational praxis, 6) orientation, 7) word recognition, 8)remembering test instructions, 9) spoken language ability, 10) word finding difficulty in spontaneous speech, and 11) comprehension.This scale had to be administered by a trained and certified psychometric rater who did not have access to any information regarding adverse events experienced. The ADAS-Cog/11 ranged from 0 to 70 points, with higher scores indicating a greater degree of impairment. A negative change from baseline indicates a decrease in cognitive impairment.|Base Study Baseline, Weeks 13, 26, 39, 52 and 78|The Modified Intent-to-Treat (mITT) Population was defined as all randomly assigned participants who received investigational product in the base study, had a baseline for the base study, had at least one valid post-baseline assessment of the ADAS-Cog and DAD total score in the base study and signed informed consent in the extension study.||Units on a scale||Standard Error|Least Squares Mean
804506|NCT00998985|Secondary|Area Under the Curve for 0 to 24 Hours Post-dose (AUC[0-24hr]) of Grazoprevir on Day 7|Blood samples were collected on Day 7 at pre-dose up to 24 hours post-dose in order to determine the AUC 0-24hrs of Grazoprevir. It is hypothesized that the Geometric Mean of Day 7 Grazoprevir AUC0-24hr. exceeds 3.2 uM.hr.|Day 7 at the following time points: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose|Participants who complied with the protocol sufficiently to ensure that these data will exhibit the effects of treatment, according to the underlying scientific model. GT1 or GT3 participants who received the same treatment were combined into a single arm. Participants with placebo were not analyzed as they did not receive grazoprevir.||uM.hr||90% Confidence Interval|Geometric Mean
804493|NCT00998764|Secondary|Change From Base Study Baseline in Alzheimer's Disease Assesment Scale-Cognitive Subscale (ADAS-Cog/11) at Weeks 13, 26, 39, 52 and 78|The ADAS-Cog is a multi-item, objective measure of cognitive function. The scale evaluates memory, language, and praxis with items such as orientation, word recall, word recognition, object identification, comprehension, and the completion of simple tasks. Analysis of the ADAS-Cog for this study was based upon an 11 item score from the following items 1) word recall task, 2) naming objects and fingers, 3) following commands, 4)constructional praxis, 5) ideational praxis, 6) orientation, 7) word recognition, 8 remembering test instructions, 9) spoken language ability, 10) word finding difficulty in spontaneous speech, and 11) comprehension.This scale had to be administered by a trained and certified psychometric rater who did not have access to any information regarding adverse events experienced. The ADAS-Cog/11 ranged from 0 to 70 points, with higher scores indicating a greater degree of impairment. A negative change from baseline indicates a decrease in cognitive impairment.|Base Study Baseline, Weeks 13, 26, 39, 52 and 78|The Modified Intent-to-Treat (mITT) Population was defined as all randomly assigned participants who received investigational product in the base study, had a baseline for the base study, had at least one valid post-baseline assessment of the ADAS-Cog and DAD total score in the base study and signed informed consent in the extension study.||Units on a scale||Standard Error|Least Squares Mean
804494|NCT00998764|Primary|Number of Participants Reporting a Serious Adverse Event|Safety was measured according to standard adverse event collection as described in the Adverse Event Section of the Results. Complete tables of events are provided there.|Up to Week 195|Safety population||Number of Participants|||Number
804495|NCT00998868|Secondary|Muscle Strength, Measured by Physical Examination, Per Medical Research Council Muscle Strength Grading System|"Muscle strength was measured for forward flexion and abduction of the shoulder per Medical Research Council (MRC) scale in each participants. Their mean +/- SD were calculated in each group.
MRC scale:
Grade 5: Normal and can move against full resistance. Grade 4: Reduced but can move against resistance. Grade 3: Can move only against gravity Grade 2: Can move without gravity Grade 1: Only a trace of movement Grade 0: No movement."|within one month after enrollment|||Units on a scale (minimum 0, maximum 5)||Standard Deviation|Mean
804496|NCT00998868|Secondary|Subluxation of the Glenohumeral Joint, Confirmed by Physical Examination|The glenohumeral joint subluxation was examined by palpating the subacromial regions of the both sides and comparing the affected side with the unaffected side while patients are seated and relaxed. If the palpated space between the acromion and the humeral head was wider on the affected side by one half finger breath or more, it was judged to be subluxation.|within one month after enrollment|||participants|||Number
804497|NCT00998868|Secondary|Rotator Cuff Tear of the Unaffected Shoulder, Confirmed by Ultrasonography|All patients were performed ultrasonography (USG) for the both, affected and unaffected, shoulders. USG routinely examined biceps, subscapularis, supraspinatus, and infraspinatus tendons as for the partial or complete tears, calcifications, bony irregularity and bursal swellings.|within one month after enrollment|||participants|||Number
804498|NCT00998868|Primary|Rotator Cuff Tear of the Hemiplegic Shoulder, Confirmed by Ultrasonography|All patients underwent ultrasonography (USG) for the both, affected and unaffected, shoulders. USG routinely examined biceps, subscapularis, supraspinatus, and infraspinatus tendons as for the partial or complete tears, calcifications, bony irregularity and bursal swellings.|within one month after enrollment|||participants|||Number
804499|NCT00998881|Secondary|Change From Baseline in 2-hour Postprandial Plasma Glucose at Week 12|The change from Baseline in 2-hour Postprandial Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline 2-hour Postprandial Plasma Glucose as a covariate.|12 weeks|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization.||mg / dL||Standard Error|Least Squares Mean
804500|NCT00998881|Secondary|Change From Baseline in the Areas Under the Curve From 0 to 2 h (AUC0–2h) for Postprandial Plasma Glucose at Week 12|The change from Baseline in AUC0–2h for Postprandial Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline AUC0–2h for Postprandial Plasma Glucose as a covariate.|12 weeks|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization.||mg*h / dL||Standard Error|Least Squares Mean
804501|NCT00998881|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 12|The change from Baseline in Fasting Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline Fasting Plasma Glucose as a covariate.|12 weeks|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization. Analysis based on last observation carried forward, where the last postbaseline double-blind observed value was carried forward and used for Week 12 where data was missing.||mg / dL||Standard Error|Least Squares Mean
804502|NCT00998881|Primary|Change From Baseline in HbA1c at Week 12|The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate.|12 weeks|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization. Analysis based on last observation carried forward, where the last postbaseline double-blind observed value was carried forward and used for Week 12 where data was missing.||Percent||Standard Error|Least Squares Mean
804503|NCT00998985|Secondary|Maximum log10 HCV RNA Reduction From Baseline Following Administration of Grazoprevir in Participants With GT3 HCV or Pooled GT1 and GT3 HCV Participants Treated With Placebo|Blood samples were collected at baseline and at intervals up to 2 months post-dose in order to determine the maximum log10 reduction from baseline in plasma HCV RNA.|Baseline and up to approximately 2 months|Participants who complied with the protocol sufficiently to ensure that these data will exhibit the effects of treatment, according to the underlying scientific model. One GT3 participant treated with 800 mg grazoprevir, who discontinued, and all GT1 participants were excluded from analysis.||log10 IU/mL||95% Confidence Interval|Least Squares Mean
815265|NCT01097694|Secondary|Bronchoalveolar Lavage (BAL) PGD2|Change in bronchoalveolar lavage (BAL) PGD2 levels from baseline at 6 months|6 months after start of treatment|||pg/mL||Standard Deviation|Mean
804507|NCT00998985|Primary|Number of Participants With Clinical and Laboratory Adverse Events (AEs)|An AE is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR’s product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR’s product, is also an AE.|All AEs: 15 Days after last dose; Serious AEs (SAEs) up to 2 months after last dose (Up to 67 days)|All participants who received at least one dose of the investigational drug according to the treatment(s) they actually received. Participants with either GT1 or GT3 who received the same treatment were combined for the summary into a single GT1 and GT3 arm.||Participants|||Number
804508|NCT00999037|Secondary|Serum Phosphate Concentration|Change in serum phosphate at 12 weeks from baseline|12 weeks|||percent change from baseline||Standard Deviation|Mean
804509|NCT00999037|Secondary|1,25(OH)2vitamin D Value|Percentage change in 1,25(OH)2vitamin D level from baseline at 12 weeks.|12 week|||percent change from baseline||Standard Deviation|Mean
804510|NCT00999037|Primary|Change in FGF-23 Level|Change in FGF23 value from baseline in response to Renvela at 12 weeks in comparison to placebo.|12 weeks|||percentage change from baseline||Standard Deviation|Mean
804511|NCT00999141|Primary|Number of AEs Related to the Investigational Product (FS VH S/D 4 S-apr)||Day 0 (day of surgery) through postoperative Day 14|Safety Analysis Set||Events|||Number
804512|NCT00999141|Other Pre-specified|Total Aspiration Volumes From Hematomas and Seromas||Through postoperative Day 14|Full Analysis Data Set = All randomized and treated participants||mL||Full Range|Median
804513|NCT00999141|Other Pre-specified|Investigators’ Confidence in Decreased Postsurgical Complications With the Use of FS VH S/D 4 S-apr||Through postoperative Day 14|Full Analysis Data Set = All randomized and treated participants||participants|||Number
804514|NCT00999141|Other Pre-specified|Investigators' Satisfaction With Treatment|During postoperative visits investigators recorded their satisfaction with treatment on each side of the face (FS VH S/D 4 s-apr (FS) or Standard of Care (SoC) sides of face)|Through postoperative Day 14|Full Analysis Data Set = All randomized and treated participants||participants|||Number
804515|NCT00999141|Other Pre-specified|Investigators' Satisfaction With Rate of Healing|During postoperative visits investigators recorded their satisfaction with the rate of healing of each side of the face (FS VH S/D 4 s-apr (FS) or Standard of Care (SoC) sides of face)|Through postoperative Day 14|Full Analysis Data Set = All randomized and treated participants||participants|||Number
804516|NCT00999141|Other Pre-specified|Investigators' Satisfaction With Quality of Flap Adherence|During postoperative visits investigators recorded their satisfaction with the quality of flap adherence for each side of the face (FS VH S/D 4 s-apr (FS) or Standard of Care (SoC) sides of face)|Through postoperative Day 14|Full Analysis Data Set = All randomized and treated participants||participants|||Number
804517|NCT00999141|Other Pre-specified|Investigator Preference for Side of Face|Investigator reported outcomes data was collected for overall preference for 1 side of face|Through postoperative Day 14|Full Analysis Data Set = All randomized and treated participants||participants|||Number
804518|NCT00999141|Other Pre-specified|Participants' Assessment of Difference in Numbness Between Two Sides of Face|"During each postoperative visit (Day 1, 3, 7, and 14), participants were asked:
How would you rate your numbness on each side of your face on a scale of 0-10, with 10 being the worst numbness possible?
Difference in scores on a scale = (SoC score) - (FS VH S/D 4 s-apr score)
The planned and approved Statistical Analysis Plan (SAP) called for a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through postoperative Day 14|Full Analysis Data Set = All randomized and treated participants||Scores on a scale||Standard Deviation|Mean
804519|NCT00999141|Secondary|Reasons for Participants’ Preferences for Side of Face|"Participants responded to the following questions during the side of face preference assessment:
Which side of the face do you prefer? Left side, right side, or no preference?
If right or left is chosen, participants were asked Please mark ALL reasons for choosing this side
Better skin sensation
Less numbness
Looks better
Less bruising
Less swelling
Less pain
Less itching
Less tingling
Less feeling of pins and needles
Other ________________ (Free Text)"|Through postoperative Day 14|Full Analysis Data Set = All randomized and treated participants||Participants|||Number
804520|NCT00999141|Secondary|Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 14|"Participants responded to the following question during the side of face preference assessment:
“Which side of the face do you prefer? Left side, right side, or no preference?”"|Through postoperative Day 14|Full Analysis Data Set = All randomized and treated participants||Proportion of Participants|||Number
804521|NCT00999141|Secondary|Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 7|"Participants responded to the following question during the side of face preference assessment:
“Which side of the face do you prefer? Left side, right side, or no preference?”"|Through postoperative Day 7|Full Analysis Data Set = All randomized and treated participants||Proportion of Participants|||Number
804522|NCT00999141|Secondary|Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 3|"Participants responded to the following question during the side of face preference assessment:
“Which side of the face do you prefer? Left side, right side, or no preference?”"|Through postoperative Day 3|Full Analysis Data Set = All randomized and treated participants||Proportion of Participants|||Number
804523|NCT00999141|Secondary|Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 1|"Participants responded to the following question during the side of face preference assessment:
“Which side of the face do you prefer? Left side, right side, or no preference?”"|Through postoperative Day 1|Full Analysis Data Set = All randomized and treated participants||Proportion of Participants|||Number
804524|NCT00999141|Secondary|Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4) on Postoperative Days 1, 3, 7, 14|"Participants responded to the following question during the side of face preference assessment:
“Which side of the face do you prefer? Left side, right side, or no preference?”"|Through postoperative Day 14|Full Analysis Data Set = All randomized and treated participants||participants|||Number
815266|NCT01097694|Secondary|BAL Eosinophil %|Change in BAL eosinophil percentage|6 months after start of treatment|||% eosinophils||Standard Deviation|Mean
804525|NCT00999141|Secondary|Change From Baseline (Day 0, Preoperative) in Skin Sensitivity on Postoperative Days 3, 7, 14|Skin sensitivity was measured using Semmes-Weinstein Monofilament set to detect neurological damage. Filament sizes are noted by handle numbers of measuring tools ([handle number = log10(10*force in milligrams applied to skin)], range = 1.65 to 6.65). Detection of filament with smaller handle number = greater skin sensitivity. Smaller change in filament size detection from pre-op to post-op = less impact to recovery of sensation. Smallest filament felt for each side of face was noted. Change in skin sensitivity computed as (Handle Number Postop Day 3, 7, or 14) - (Handle Number Preop Day 0).|Day 0 (preoperative) through postoperative Day 14|Full Analysis Data Set = All randomized and treated participants||Handle number(s)||95% Confidence Interval|Mean
804526|NCT00999141|Secondary|Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 14|Investigators' assessed which side of the face (FS VH S/D 4 s-apr or Standard SoC) had less edema|Through postoperative Day 14|Full Analysis Data Set = All randomized and treated participants||participants|||Number
804527|NCT00999141|Secondary|Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 7|Investigators' assessed which side of the face (FS VH S/D 4 s-apr or Standard SoC) had less edema|Through postoperative Day 7|Full Analysis Data Set = All randomized and treated participants||participants|||Number
804528|NCT00999141|Secondary|Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 3|Investigators' assessed which side of the face (FS VH S/D 4 s-apr or Standard SoC) had less edema|Through postoperative Day 3|Full Analysis Data Set = All randomized and treated participants||participants|||Number
804529|NCT00999141|Secondary|Investigators’ Visual Comparisons of Edema Between the 2 Sides of Face at Day 1|Investigators’ assessed which side of the face (FS VH S/D 4 s-apr or Standard SoC) had less edema|Through postoperative Day 1|Full Analysis Data Set = All randomized and treated participants||participants|||Number
804530|NCT00999141|Secondary|Number of Participants With Hematoma/Seroma Anytime During the Study||Day 0 (day of surgery) through postoperative Day 14|Full Analysis Data Set = All randomized and treated participants||participants|||Number
804531|NCT00999141|Secondary|Participants With Hematoma/Seroma by Study Day|Investigators assessed each side of the face for the presence of hematoma and/or seroma|Day 0 (day of surgery) through postoperative day 14|Full Analysis Data Set = All randomized and treated participants||participants|||Number
804532|NCT00999141|Secondary|Participants' First Occurrence of Hematoma or Seroma by Study Day|Investigators assessed each side of the face for the presence of hematomas and/or seromas|Day 0 (day of surgery) through postoperative day 14|Full Analysis Data Set = All randomized and treated participants||participants|||Number
804533|NCT00999141|Primary|Total Volume of Drainage on Each Side of the Face|Total drainage volume collected from each side of the face. One side of face is treated with FS VH S/D 4 s-apr (FS); the other side is treated using standard of care (SoC).|24 hours (± 4h) after surgery|Full Analysis Data Set = All randomized and treated participants||mL||Full Range|Median
804534|NCT00999167|Secondary|Change From Baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Score|Changes from Baseline to Day 56 and the Final Visit were compared between treatment groups using an ANCOVA model for the total index RBANS score ). The index score is a sum of the scores for each of the 5 individual domains (immediate memory, visuospatial/constructional, language, attention). The minimum and maximum total index scores are 40 and 160, respectively; a higher score is better.|Day 56, Final Visit (D112)|Intent to treat (ITT)||units on a scale||Standard Error|Least Squares Mean
804535|NCT00999167|Secondary|Time to Meeting the Primary Endpoint|Secondary efficacy endpoint. The time to the first HE episode during the treatment period was calculated using the Kaplan-Meier method. Subjects who did not experience an HE episode were censored at the time of their last asterixis assessment. Subjects who had no post-randomization data for the primary endpoint were considered to have an HE episode at Day 1.|112 Days|Intent to treat (ITT)||Days||95% Confidence Interval|Median
804536|NCT00999167|Primary|Part B: Proportion of Subjects Who Exhibit an HE Episode, Defined as Either of the Following During the Treatment Phase: WH ≥2; WH Grade and Asterixis Grade Increase of 1 Each, if Baseline WH = 0|"An HE event was defined as occurrences of either a West Haven (WH) Grade ≥2 or a WH Grade 1 and asterixis grade increase of 1 (if baseline WH = 0).
The WH criteria are widely used for rating the severity of HE and are summarized below:
Grade 1: trivial lack of awareness, euphoria or anxiety, shortened attention span, impaired performance of addition Grade 2: lethargy or apathy, minimal disorientation for time or place, subtle personality change, inappropriate behavior, impaired performance of subtraction Grade 3: somnolence to semi-stupor but responsive to verbal stimuli, confusion, gross disorientation Grade 4: coma (unresponsive to verbal or noxious stimuli)
Asterixis was assessed after arm and forearm extension along with wrist dorsiflexion for 30 seconds and assigned a grade according to the following criteria:
Grade 1: rare flaps Grade 2: occasional irregular flaps Grade 3: frequent flaps Grade 4: continuous flaps"|Part B: 112 Days|Intent to Treat (ITT)||participants|||Number
804537|NCT00999167|Secondary|Total Number of HE Events|Secondary efficacy endpoint. The total number of HE events during the treatment phase for subjects in the placebo and active arms.|112 Days|Intent to treat (ITT)||HE event|||Number
804538|NCT00999167|Primary|Part A: The Rate of AEs and Tolerability of HPN-100|Part A: The rate of AEs and tolerability of 6 mL and 9 mL doses of HPN-100 were considered the primary safety endpoints for Part A. Safety assessments included adverse events, laboratory tests (including ammonia, hematology, coagulation, liver function and serum chemistry parameters), vital signs, physical and neurological examinations, and electrocardiograms.|Part A: 28 days|Safety population||Subjects|||Number
804539|NCT00985829|Other Pre-specified|Past Medical History of Radiotherapy|past medical history of radiotherapy to the site of tumor before its appearance(for another reason)|baseline|||lesions|||Number
804540|NCT00985829|Other Pre-specified|BCC Type|superficial BCC (sBCC); pigmented BCC(pBCC);nodular BCC (nBCC)|baseline|||lesions|||Number
804541|NCT00985829|Other Pre-specified|Location of Lesion||baseline|||lesions|||Number
804542|NCT00985829|Other Pre-specified|Cosmetic Result|excellent: no scarring, atrophy, or induration, slight or no redness or change in pigmentation compared to the adjacent skin; good: no scarring, atrophy, or induration, moderate redness or increase in pigmentation compared to the adjacent skin; moderate: slight to moderate scarring, atrophy, or induration; and poor: extensive scarring, atrophy, or induration|1 month after termination of treatment course (with an average of 6 months after initiation of PDT)|cosmetic result was assessed among patients with complete response||lesions|||Number
804544|NCT00985829|Primary|Clinical Response to Photodynamic Therapy|categorized in 3 groups: complete response: there was no visible or palpable lesion; partial response: there was a visible or palpable lesion but the diameter of the lesion had reduced; no response: there was a visible or palpable lesion and the diameter of the lesion had not reduced|immediately after termination of treatment course (with an average of 5 month after initiation of PDT)|||lesions|||Number
804545|NCT00991276|Secondary|Restless Leg Syndrome - Quality of Life Scale (RLS-QoL)|RLS-QoL: psychometrically and clinically valid and reliable participant-rated instrument, assesses impact of RLS on participant quality of life. Specifically, it assessed effects of RLS on health status function (symptom severity, daily activity, social functioning, sleep, concentrating and decision making, travelling, sexual activity, and work) giving a summary score ranging from 0-100. Higher scores reflect better quality of life. Recall period: 1 week prior to assessment. Arithmetic mean of RLS-QoL score of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||units on a scale||95% Confidence Interval|Least Squares Mean
804546|NCT00991276|Secondary|Medical Outcomes Study - Sleep Scale (MOS-SS)|MOS-SS:Participant rated instrument, assesses sleep quantity, quality;with 12 items(7 subscale scores:sleep disturbance, snoring, awakening short of breath/with headache, sleep adequacy, somnolence, sleep quantity, optimal sleep;2 composite index scores:sleep problems Index I, II). Subscale scores total range:0-100(except sleep quantity[range 0-24 hours], optimal sleep[range 0-1: 0= <7 or >8 hours;1=7/8 hours]). Higher scores=poorer sleep outcomes(except sleep quantity, adequacy). Arithmetic mean of MOS-SS scores of each participant for all periods was taken before linear mixed model analysis.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|"ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. Here n signifies number of participants analyzed for particular subscale for each arm group respectively."||units on a scale||95% Confidence Interval|Least Squares Mean
804547|NCT00991276|Secondary|Subjective Sleep Questionnaire (SSQ): Latency Subscale|SSQ: participant-rated instrument assesses sleep behavior; measures sleep quantity, quality. Comprised of 5 items giving 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, quality of sleep. Latency (time to fall asleep [in minutes]): numerical rating completed by participant 30 minutes after waking; recall period: night before. Range: 0 - 840 minutes, lower value: better sleep. Arithmetic mean of subscale score of each participant for all periods was taken prior to employing linear mixed model. Hours of sleep subscale results reported as sTST.|Week 3 and Week 5 of each intervention period or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||minutes||95% Confidence Interval|Least Squares Mean
804548|NCT00991276|Secondary|Subjective Sleep Questionnaire (SSQ): Quality of Sleep Subscale|SSQ: participant-rated instrument to assess sleep behavior; measures sleep quantity, quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, quality of sleep. This 1 item subscale: numerical rating completed by participant 30 minutes after waking; recall period: night before, Range: 0 to 100, higher score: better quality of sleep. Arithmetic mean of this subscale score of each participant for all periods was taken prior to employing linear mixed model. Results of hours of sleep subscale reported as sTST.|Week 3 and Week 5 of each intervention period or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||units on a scale||95% Confidence Interval|Least Squares Mean
804549|NCT00991276|Secondary|Subjective Sleep Questionnaire (SSQ): Total Wake Time After Sleep Onset Subscale|SSQ: participant-rated instrument to assess sleep behavior; measures sleep quantity, quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, quality of sleep. This 1 item subscale (in minutes): numerical rating completed by participant 30 minutes after waking; recall period: night before. Range: 0-1440 minutes. Lower value: better sleep. Arithmetic mean of this subscale score of each participant for all periods was taken prior to employing linear mixed model. Results of hours of sleep subscale reported as sTST.|Week 3 and Week 5 of each intervention period or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||minutes||95% Confidence Interval|Least Squares Mean
804550|NCT00991276|Secondary|Subjective Sleep Questionnaire (SSQ): Number of Awakenings Subscale|SSQ: participant-rated instrument to assess sleep behavior; measures sleep quantity, quality. Comprised of 5 items giving 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, quality of sleep. This (1 item) subscale: numerical rating completed by participant 30 minutes after waking; recall period: night before. Range: 0 awakenings to 30 awakenings. Lower value indicates better quality of sleep. Arithmetic mean of this subscale score of each participant for all periods was taken prior to employing linear mixed model. Results of hours of sleep subscale reported as sTST.|Week 3 and Week 5 of Each Intervention Period or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||awakenings||95% Confidence Interval|Least Squares Mean
804559|NCT00991276|Secondary|Wake Time After Sleep (WTAS)|WTAS, as determined by PSG, was the number of wake (30-sec) epochs after the final awakening until the end of the 8-hour recording. WTAS was the sum of 2 consecutive days of recordings divided by 2 at the end of each intervention period. Arithmetic mean of WTAS of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||minutes||95% Confidence Interval|Least Squares Mean
804551|NCT00991276|Secondary|Hourly and Quarterly Assessment of Sleep Efficiency (SE)|SE, as determined by PSG, was the TST divided by the time in bed (TIB)(both in minutes), multiplied by 100. Sum of 2 consecutive days of recording divided by 2 at the end of each intervention period by each individual hour (8 hours total) and each individual quarter of the night (eight hours in 2 hour increments). Arithmetic mean for SE of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least one dose of study medication and had at least one post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||percentage of time asleep||95% Confidence Interval|Least Squares Mean
804552|NCT00991276|Secondary|Hourly and Quarterly Assessment of Periodic Limb Movement (PLM)|PLM, as determined by PSG was number of periodic limb movements based on time in bed (TIB). Calculated at each individual hour (8 hours total) and each individual quarter of the night (eight hours in 2 hour increments). Arithmetic mean of PLM of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least one dose of study medication and had at least one post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||movement/hour||95% Confidence Interval|Least Squares Mean
804553|NCT00991276|Secondary|Hourly and Quarterly Assessment of Number of Arousals (NASO)|NASO, as determined by PSG was the number of times there is a shift from a stage N2 to N3 or R 30-sec epoch to a stage N1 30-sec epoch from the onset of persistent sleep to light on. The sum of 2 consecutive days of recording was divided by 2 at the end of each intervention period by each individual hour (8 hours total) and each individual quarter of the night (eight hours in 2 hour increments). Arithmetic mean of NASO for each participant at each period was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|"ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. Here n signifies number of participants analyzed at that particular time point for each arm group respectively."||arousals||95% Confidence Interval|Least Squares Mean
804554|NCT00991276|Secondary|Hourly and Quarterly Assessment of Number of Awakenings of at Least 2 Epoch After Sleep Onset (NAASO2)|NAASO2, as determined by PSG, was the number of times there was a wake period of at least 2 30-sec epochs from the onset of persistent sleep to light on. Each entry to be counted must be separated by a Stage N2 30-sec epoch, Stage N3 30-sec epoch, or Stage R 30-sec epoch. The sum of 2 consecutive days of recording was divided by 2 at the end of each intervention period by each individual hour (8 hours total) and each individual quarter of the night (eight hours in 2 hour increments). Arithmetic mean of NAASO2 of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|"ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. Here n signifies number of participants analyzed at that particular time point for each arm group respectively."||awakenings||95% Confidence Interval|Least Squares Mean
804555|NCT00991276|Secondary|Hourly and Quarterly Assessment of Number of Awakenings of at Least 1 Epoch After Sleep Onset (NAASO1)|NAASO1, as determined by PSG, was the number of times there was a wake period of at least 1 30-sec epoch from the onset of persistent sleep to light on. Each entry to be counted must be separated by a Stage N2 30-sec epoch, Stage N3 30-sec epoch, or Stage R 30-sec epoch. The sum of 2 consecutive days of recording was divided by 2 at the end of each intervention period by each individual hour (8 hours total) and each individual quarter of the night (eight hours in 2 hour increments). Arithmetic mean of NAASO1 of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|"ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. Here n signifies number of participants analyzed at that particular time point for each arm group respectively."||awakenings||95% Confidence Interval|Least Squares Mean
804556|NCT00991276|Secondary|Hourly and Quarterly Assessment of Wake After Sleep Onset (WASO)|WASO, as determined by PSG was time spent awake from sleep onset to final awakening. WASO = (sum of WTDS 30-sec epochs and WTAS 30-sec epochs)/2, measured on 2 consecutive days at end of each intervention period by each individual hour (8 hours total) and each individual quarter of night (eight hours in 2 hour increments). Arithmetic mean of WASO of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|"ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. Here n signifies number of participants analyzed at that particular time point for each arm group respectively."||minutes||95% Confidence Interval|Least Squares Mean
804557|NCT00991276|Secondary|Sleep Efficiency (SE)|SE, as determined by PSG, was the TST divided by the time in bed (TIB)(both in minutes), multiplied by 100. Sum of 2 consecutive days of recording divided by 2 at the end of each intervention period. Arithmetic mean of SE of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||Percentage of time asleep||95% Confidence Interval|Least Squares Mean
804558|NCT00991276|Secondary|Total Sleep Time (TST)|TST, as determined by PSG, was the number of non-wake (30-sec) epochs from the beginning of recording to the end of the recording. TST was the sum of 2 consecutive days of recording divided by 2 at the end of each intervention period. Arithmetic mean of TST of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||minutes||95% Confidence Interval|Least Squares Mean
804560|NCT00991276|Secondary|Wake Time During Sleep (WTDS)|WTDS, as determined by PSG, was the number of wake (30-sec) epochs after the onset of persistent sleep and prior to the final awakening or at the end of 8-hour recording. WTDS was the sum of 2 consecutive days of recordings divided by 2 at the end of each intervention period. Arithmetic mean of WTDS of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||minutes||95% Confidence Interval|Least Squares Mean
804561|NCT00991276|Secondary|Latency to Persistent Sleep (LPS)|LPS, as determined by PSG, was number of epochs from the beginning of the recording (“lights-out”) to the start of the first 20 consecutive non-wake epochs (10 minutes of persistent sleep) divided by 2. Arithmetic mean of LPS of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||minutes||95% Confidence Interval|Least Squares Mean
804562|NCT00991276|Secondary|Latency to Stage R Sleep (LREM)|LREM, as determined by PSG, was number of non-wake epochs from the beginning of the recording to the first occurrence of Stage R sleep divided by 2. Arithmetic mean of LREM of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||minutes||95% Confidence Interval|Least Squares Mean
804563|NCT00991276|Secondary|Percentage of Participants With Response to Clinical Global Impression - Improvement (CGI-I) Scale|CGI-I: 7-point clinician rated scale to assess improvement in disease condition as compared to the start of the study medication (baseline), ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved). Higher score = more affected.|Baseline, Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||percentage of participants|||Number
804564|NCT00991276|Secondary|International Restless Legs Syndrome Study Group Rating Scale (IRLS)|IRLS: psychometrically; clinically valid; clinician-administered instrument assesses severity of RLS. RLS symptom severity and impact on daily living comprise of 10 items giving 2 subscale scores and 1 global score. Subscale scores: symptom severity(6 items) and impact on daily living(3 items), item 3 loaded equally on both subscales. Global score calculated from 10 items. Score of all items range from 0-4, total score range:0-40. Lower scores: lower severity and better quality of life. Arithmetic mean of IRLS of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||units on a scale||95% Confidence Interval|Least Squares Mean
804565|NCT00991276|Secondary|Arousal Index (NASOI)|Arousal index, as determined by PSG, was NASO per hours of sleep from the onset of persistent sleep to light on. Arithmetic mean of NASOI of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||arousals/hour||95% Confidence Interval|Least Squares Mean
804566|NCT00991276|Secondary|Number of Arousals (NASO)|NASO, as determined by PSG, was calculated as number of times there is a shift from a stage N2 to N3 or R 30-sec epoch to a stage N1 30-sec epoch from the onset of persistent sleep to light on. The sum of 2 consecutive days of recording was divided by 2 at the end of each intervention period. Arithmetic mean of NASO of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||arousals||95% Confidence Interval|Least Squares Mean
804567|NCT00991276|Secondary|Number of Awakenings of at Least 2 Epochs After Sleep Onset (NAASO2)|NAASO2, as determined by PSG, was the number of times there was a wake period of at least 2 30-sec epochs from the onset of persistent sleep to light on. Each entry to be counted must be separated by a Stage N2 30-sec epoch, Stage N3 30-sec epoch, or Stage R 30-sec epoch. The sum of 2 consecutive days of recording was divided by 2 at the end of each intervention period. Arithmetic mean of NAASO2 of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||awakenings||95% Confidence Interval|Least Squares Mean
804568|NCT00991276|Secondary|Periodic Limb Movement in Sleep Index (PLMSI)|PLMSI, as determined by PSG was number of periodic limb movements in sleep per hour based on TST. Arithmetic mean of PLMSI of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||movement/hour||95% Confidence Interval|Least Squares Mean
804569|NCT00991276|Secondary|Periodic Limb Movement Index (PLMI)|PLMI, as determined by PSG was number of periodic limb movements per hour based on time in bed (TIB). Arithmetic mean of PLMI of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||movement/hour||95% Confidence Interval|Least Squares Mean
804570|NCT00991276|Secondary|Restless Legs Syndrome-Next Day Impact (RLS-NDI)|RLS-NDI:participant-rated instrument to assess daytime performance and participant’s previous night’s sleep, consists of 14 items encompassing 5 domains:tiredness;emotional functioning;social functioning;cognitive functioning;activities of daily living and 1 global item for overall well-being. Each item: 0-10 scale; 0=Not at all; 10=Extremely. Total score: sum of scores from question 1-14 (question 10, 11: scores reversed). Total score range: 0-140; higher scores: more severe impact. Arithmetic mean of RLS-NDI of each participant for all periods was taken prior to employing linear mixed model.|Week 3 and Week 5 of Each Intervention Period or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||units on a scale||95% Confidence Interval|Least Squares Mean
804571|NCT00991276|Secondary|Number of Awakenings of at Least 1 Epoch After Sleep Onset (NAASO1)|NAASO1, as determined by PSG, was the number of times there was a wake period of at least 1 epoch from the onset of persistent sleep to light on. Each entry to be counted must be separated by a Stage 2 Non-REM [Stage N2] 30-second (30-sec) epoch, Stage 3 Non-REM [Stage N3] 30-sec epoch, or stage rapid eye movement [stage R] 30-sec epoch. The sum of 2 consecutive days of recording was divided by 2 at the end of each intervention period. Arithmetic mean of NAASO1 of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||awakenings||95% Confidence Interval|Least Squares Mean
804572|NCT00991276|Secondary|Minutes of Stage N1, N2, N3 and R Sleep|Minutes of Stage 1 Non-Rapid Eye Movement (Non-REM) sleep (Stage N1), Stage 2 Non-REM sleep (Stage N2), Stage 3 Non-REM sleep (Stage N3) or Slow Wave Sleep (SWS) and Stage REM (Stage R) sleep, as determined by PSG were calculated as total number of Stage N1 30-second (30-sec) epochs divided by 2, total number of Stage N2 30-sec epochs divided by 2, total number of Stage N3 30-sec epochs divided by 2 and total number of Stage R 30-sec epochs divided by 2 respectively. Arithmetic mean of minutes of stage N1, N2, N3 and R sleep of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||minutes||95% Confidence Interval|Least Squares Mean
804573|NCT00991276|Secondary|Subjective Total Sleep Time (sTST)|sTST as derived from Subjective Sleep Questionnaire (SSQ), a participant reported subjective estimate of the total amount of time the participant was asleep after lights out until final awakening. Completed by the participant 30 minutes after waking; recall period is the night before. Arithmetic mean of sTST of each participant for all periods was taken prior to employing linear mixed model.|Week 3 and Week 5 of Each Intervention Period or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||minutes||95% Confidence Interval|Least Squares Mean
804574|NCT00991276|Secondary|Periodic Limb Movement Arousal Index (PLMAI)|PLMAI, as determined by PSG was number of periodic limb movements leading to arousal per hour (per hour of Total Sleep Time [TST]). Arithmetic mean of PLMAI of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least one post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||movement/hour||95% Confidence Interval|Least Squares Mean
804575|NCT00991276|Primary|Wake After Sleep Onset (WASO)|WASO as determined by Polysomnography (PSG) was time spent awake from sleep onset to final awakening. WASO= Wake Time During Sleep [WTDS] epochs + Wake Time After Sleep [WTAS] epochs)/2. WTDS: number of wake epochs (30 seconds of PSG recording) after onset of persistent sleep and prior to final awakening or end of 8-hour recording/2 and WTAS: number of wake epochs after final awakening until end of the 8-hour recording/2. WASO was measured on 2 consecutive days within a period. Arithmetic mean of WASO of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or Early Termination (ET)|Intent to Treat (ITT) population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||minutes||95% Confidence Interval|Least Squares Mean
804576|NCT00991289|Secondary|Number of Participants With HCV Genotype 1|Confirmatory HCV genotyping was performed on stored plasma from entry using VERSANT HCV Genotype assay v2.0 (LiPA, RUO, Siemens Healthcare Diagnostics Inc., Tarrytown, NY).|Week 0|All participants who enrolled, except one participant who was found to have been ineligible after entry.||participants|||Number
804577|NCT00991289|Secondary|Change in log10 HCV Viral Load After 4 Weeks of Nitazoxanide (NTZ) Monotherapy.|Change in log10 HCV viral load was calculated as log10-transformed HCV viral load at Week 4 minus log10-transformed HCV viral load at study entry. HCV viral load testing was done using Cobas AmpliPrep/Taqman HCV Test.|Weeks 0, 4|All participants who enrolled, except one participant who was found to have been ineligible after entry, and had HCV viral load measurements available at entry and at Week 4 were analyzed.||log10 IU/mL||Inter-Quartile Range|Median
815267|NCT01097694|Secondary|BAL Neutrophil %|Change in BAL neutrophil percentage from baseline|6 months after start of treatment|||% neutrophils||Standard Deviation|Mean
804578|NCT00991289|Secondary|Percent Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) From Study Entry|HOMA-IR was calculated as [fasting glucose (mg/dL) x fasting insulin (uIU/mL)]/405. Percent Change in HOMA-IR was calculated as HOMA-IR at later time point (16, 28, 52, 76) minus HOMA-IR at study entry, divided by HOMA-IR at study entry x 100%. Study protocol required fasting for at least 8 hours (nothing by mouth except medications and water) prior to specimen collection for fasting insulin and fasting glucose testing.|Weeks 0, 16, 28, 52, and 76|All participants who enrolled, except one participant who was found to have been ineligible after entry, and had fasting insulin and fasting glucose measurements available at entry and the respective post-entry time point: 56 at Week 16, 39 at Week 28, 27 at Week 52 and 22 at Week 76.||percentage of HOMA-IR at study entry||Inter-Quartile Range|Median
804579|NCT00991289|Secondary|Percent Change in Fasting Glucose Level From Study Entry|Percent Change in fasting glucose (FGLUC) was calculated as FGLUC at later time point (16, 28, 52, 76) minus FGLUC at study entry, divided by FGLUC at study entry x 100%. Study protocol required fasting for at least 8 hours (nothing by mouth except medications and water) prior to specimen collection for fasting glucose testing.|Weeks 0, 16, 28, 52, and 76|All participants who enrolled, except one participant who was found to have been ineligible after entry, and had FGLUC measurement available at entry and the respective post-entry time point: 58 at Week 16, 41 at Week 28, 29 at Week 52 and 24 at Week 76.||percentage of FGLUC at study entry||Inter-Quartile Range|Median
804580|NCT00991289|Secondary|Percent Change in Fasting Insulin Level From Study Entry|Percent Change in fasting insulin (FINS) was calculated as FINS at later time point (16, 28, 52, 76) minus FINS at study entry, divided by FINS at study entry x 100%. Study protocol required fasting for at least 8 hours (nothing by mouth except medications and water) prior to specimen collection for fasting insulin testing.|Weeks 0, 16, 28, 52, and 76|All participants who enrolled, except one participant who was found to have been ineligible after entry, and had FINS measurement available at entry and the respective post-entry time point: 58 at Week 16, 40 at Week 28, 28 at Week 52 and 23 at Week 76.||percentage of FINS at study entry||Inter-Quartile Range|Median
804581|NCT00991289|Secondary|Change in Hemoglobin Level From Study Entry|Change in hemoglobin (HGB) was calculated as HGB at later time point (Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 76) minus HGB at study entry.|Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 76.|All participants who enrolled, except one participant who was found to have been ineligible after entry, and had HGB measurement available at entry and at the respective post-entry time point: 65, 65, 63, 60, 55, 51, 45, 38, 39, 34, 31, 32, 31 and 29 participants at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 76, respectively.||g/dL||Inter-Quartile Range|Median
804582|NCT00991289|Secondary|Number of Participants With Adverse Events of Grade 2 or Higher|Number of participants who experienced an adverse event of Grade 2 or higher at any time after study entry. Grading of adverse events (signs and symptoms and laboratory toxicities) was according to Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, December 2004.|From study entry to up to week 76|All participants who enrolled, except one participant who was found to have been ineligible after entry.||participants|||Number
804583|NCT00991289|Secondary|Percentage of Participants With Rapid Virologic Response (RVR)|Rapid virologic response (RVR) was defined as undetectable HCV viral load (<43 IU/ml) at Week 8 where 43 is the lower limit of quantification of the assay (Cobas AmpliPrep/Taqman HCV Test).|Week 8|All participants who enrolled, except one participant who was found to have been ineligible after entry. The analysis was intention to treat wherein participants who dropped out early without Week 8 HCV viral load result were considered non-responders.||percentage of participants||90% Confidence Interval|Number
804584|NCT00991289|Secondary|Percentage of Participants With Sustained Virologic Response (SVR)|Sustained virologic response (SVR) was defined as undetectable HCV viral load (<43 IU/ml) at 24 weeks after treatment discontinuation, where 43 is the lower limit of quantification of the assay (Cobas AmpliPrep/Taqman HCV Test). Participants who failed to achieve EVR or had detectable HCV RNA at Week 28 and per protocol discontinued study, and participants without HCV RNA from 24 weeks after treatment discontinuation, were considered non-responders.|24 weeks after treatment discontinuation|All participants who enrolled, except one who was found to have been ineligible after entry. The analysis was intention to treat wherein participants who dropped out early without HCV RNA from 24 weeks after treatment discontinuation, non-EVRs and those with detectable HCV RNA at Week 28, were considered non-responders.||percentage of participants||90% Confidence Interval|Number
804585|NCT00991289|Primary|Percentage of Participants With Early Virologic Response (EVR)|Early virologic response (EVR) was defined as undetectable HCV viral load (<43 IU/ml) at Week 16 or at least a 2-log10 decrease in HCV viral load from study entry at Week 16, where 43 is the lower limit of quantification of the assay (Cobas AmpliPrep/Taqman HCV Test).|Weeks 0, 16|All participants who enrolled, except one participant who was found to have been ineligible after entry. The analysis was intention to treat wherein participants who dropped out early without Week 16 HCV viral load result were considered non-responders.||percentage of participants||90% Confidence Interval|Number
804586|NCT00991289|Primary|Percentage of Participants With Complete Early Virologic Response (cEVR)|Complete early virologic response (cEVR) was defined as undetectable HCV viral load (<43 IU/ml) at week 16, where 43 is the lower limit of quantification of the assay (Cobas AmpliPrep/Taqman HCV Test).|Week 16|All participants who enrolled, except one participant who was found to have been ineligible after entry. The analysis was intention to treat wherein participants who dropped out early without Week 16 HCV viral load result were considered non-responders.||percentage of participants||90% Confidence Interval|Number
804587|NCT00991302|Secondary|Cumulative Probability of First Grade 3 or 4 Adverse Events (AEs)|"The Kaplan-Meier estimate of the cumulative probability of experiencing a grade 3 or 4 adverse event by week 72.
New Grade 3 or 4 signs, symptoms were identified by MedDRA preferred term. Events were included regardless of participant status on ART. If a participant had multiple reports of the same event, only the event reported at the highest grade were included.
Time was measured from the study entry until the date of the first new grade 3 or 4 adverse event. Participants lost to follow-up prior to reaching an adverse event endpoint or not documented to have reached an adverse event endpoint at the end of the study had their endpoint censored at the date of their last visit."|From study entry to week 72|Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment.||cumulative probability per 100 persons||95% Confidence Interval|Number
804588|NCT00991302|Secondary|Self-management Skills, as Measured by Self-reported General Self-efficacy Scale (GSES) Score|"The GSES is a 10-item scale designed to assess optimistic self-beliefs used to cope with a variety of demands in life. The scale was designed to assess self efficacy, i.e., the belief that one’s actions are responsible for successful outcomes. The scaled score for each question ranges from 1 to 4. Higher scores indicate participant’s stronger belief in self-efficacy.
The GSES score was sum of all responses. The range was from 0 to 40 scores: any unfinished question got a score of zero."|At weeks 0 (entry), 4, 12, 24, 36, 48, 60, and 72|Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment.||scores on a scale||Inter-Quartile Range|Median
804589|NCT00991302|Secondary|Virologic Suppression|Virologic suppression was defined as HIV-1 RNA <=200 copies/mL at week 24, 48, and 72. The results obtained within +/- 12 weeks of 24, 48, and 72 weeks were included. If there were multiple HIV-1 RNA measurement within the specified window, the HIV-1 RNA result closest to the center of the window was selected.|At week 24, 48, 72|Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment.||percentage of participants||95% Confidence Interval|Number
804590|NCT00991302|Secondary|Kaplan-Meier Estimate of the Cumulative Probability of Time to Change of Initial Antiretroviral (ARV) Treatment Regimen for Any Reason by Week 48|"The Kaplan-Meier estimate of the cumulative probability of initial antiretroviral (ARV) treatment regimen for any reason by week 48.
Time to ARV treatment regimen change was defined as first time to change in the drug class of participant's ART regimen for any reason from study entry. Participants completing the study without a change in the drug class of their ART regimen were censored at their last visit."|From study entry to week 48|Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment.||cumulative probability per 100 persons||95% Confidence Interval|Number
804591|NCT00991302|Secondary|Mean Self-reported Adherence Score Over a One-month Recall|The mean of participant's average self-reported adherence score over a one-month recall across visit week 4, 12, 24, 36, 48, 60, and 72; missing values were ignored.|Weeks 4, 12, 24, 36, 48, 60, and 72|Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment. Missing data were assumed missing completely at random.||percentage of adherence score||Inter-Quartile Range|Median
804592|NCT00991302|Primary|Mean Self-reported Adherence Score (%) Over a One-month Recall|"The adherence self-report questionnaire captured adherence at an Antiretroviral Therapy (ART) regimen over a one-month recall (0-100): 0 means none of anti-HIV medications were taken, 100 means every single dose of anti-HIV medications were taken. The primary endpoint evaluated for each participant was the average self-reported adherence over a one-month recall across each of their study visit week 4, 12, 24, 36, and 48: missing values were ignored.
Note: This was a change to the primary endpoint as described in the study protocol. This was due to an update to ACTG Case Report Form (CRF) that captured self-report adherence. Since the data captured on this form captured adherence over a longer timeframe and allowed for more variability in response, it was anticipated this endpoint would provide greater power to assess treatment differences."|At weeks 4, 12, 24, 36, and 48|Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment. Missing data were assumed missing completely at random.||percentage of adherence score||Inter-Quartile Range|Median
804593|NCT00991341|Secondary|Any Mechanical Ventilation More Than 48 Hours Post-operation||48 hours post-operation through day 28, hospital discharge, or death, whichever occurs first|Analysis is restricted to evaluable subjects (defined as randomized subjects who underwent cardiac surgery within 30 days after randomization and received at least one RBC transfusion between randomization and post-operative hour 96).||participants with event|||Number
804594|NCT00991341|Secondary|Days Alive and Ventilator Free Through Post-op Day 28||Through post-op day 28|Analysis is restricted to evaluable subjects (defined as randomized subjects who underwent cardiac surgery within 30 days after randomization and received at least one RBC transfusion between randomization and post-operative hour 96).||days||Standard Deviation|Mean
804595|NCT00991341|Secondary|Days to First Solid Food|Subjects were randomized for RECESS no earlier than one calendar day before the planned date of surgery, and were followed until post-operative Day 28, death, or study withdrawal, whichever occurred first. In some cases the surgery was postponed after randomization had already occurred. If surgery did not occur within 30 days after randomization, the subject ended the study and was not considered evaluable. If surgery did occur within 30 days after randomization, and the subject received at least one RBC transfusion between randomization and 96 hours after the end of surgery, the subject was considered evaluable. Therefore, in a few evaluable subjects, post-operative Day 28 could be nearly two months after the date of randomization. The times in the time-to-event analyses are from randomization to first post-operative solid food.|Through post-operative day 28, hospital discharge, or death, whichever occurs first|Analysis is restricted to evaluable subjects (defined as randomized subjects who underwent cardiac surgery within 30 days after randomization and received at least one RBC transfusion between randomization and post-operative hour 96). The mean time to an event is estimated by the area under the survival function.||days||Standard Error|Mean
804596|NCT00991341|Secondary|Days to First Bowel Movement|Subjects were randomized for RECESS no earlier than one calendar day before the planned date of surgery, and were followed until post-operative Day 28, death, or study withdrawal, whichever occurred first. In some cases the surgery was postponed after randomization had already occurred. If surgery did not occur within 30 days after randomization, the subject ended the study and was not considered evaluable. If surgery did occur within 30 days after randomization, and the subject received at least one RBC transfusion between randomization and 96 hours after the end of surgery, the subject was considered evaluable. Therefore, in a few evaluable subjects, post-operative Day 28 could be nearly two months after the date of randomization. The times in the time-to-event analyses are from randomization to first post-operative bowel movement.|Through post-operative day 28, hospital discharge, or death, whichever occurs first|Analysis is restricted to evaluable subjects (defined as randomized subjects who underwent cardiac surgery within 30 days after randomization and received at least one RBC transfusion between randomization and post-operative hour 96). The mean time to an event is estimated by the area under the survival function.||days||Standard Error|Mean
815732|NCT01100762|Primary|First Step Velocity|First step velocity was measured in meters per second|Data collection occurred before and immediately after each training session|||m/sec||Standard Deviation|Mean
804597|NCT00991341|Secondary|Change in ALT From Pre-operative Value to Worst Post-operative Value (for Pediatric Subjects Only)||Through post-operative day 7, hospital discharge, or death, whichever occurs first|Only 4 pediatric subjects were enrolled. One treatment arm had only one subject with available data for analyzing the change in ALT. Therefore, to protect patient confidentiality, results were not entered.|||||
804598|NCT00991341|Secondary|Change in Bilirubin From Pre-operative Value to Worst Post-operative Value||Through post-operative day 7, hospital discharge, or death, whichever occurs first|Analysis is restricted to evaluable subjects (defined as randomized subjects who underwent cardiac surgery within 30 days after randomization and received at least one RBC transfusion between randomization and post-operative hour 96).||mg/dL||Standard Deviation|Mean
804599|NCT00991341|Secondary|Change in Lactate From Pre-operative Value to Worst Post-operative Value|The arterial lactate levels were adjusted to make them comparable to venous lactate levels.|Through post-operative day 7, hospital discharge, or death, whichever occurs first|Analysis is restricted to evaluable subjects (defined as randomized subjects who underwent cardiac surgery within 30 days after randomization and received at least one RBC transfusion between randomization and post-operative hour 96).||mmol/L||Standard Deviation|Mean
804600|NCT00991341|Secondary|Change in Troponin-I From Pre-operative Value to Worst Post-operative Value||Through post-operative day 7, hospital discharge, or death, whichever occurs first|Analysis is restricted to evaluable subjects (defined as randomized subjects who underwent cardiac surgery within 30 days after randomization and received at least one RBC transfusion between randomization and post-operative hour 96).||ng/mL||Standard Deviation|Mean
804601|NCT00991341|Secondary|Change in Serum Creatinine From Pre-operative Value to Worst Post-operative Value||Through post-operative day 7, hospital discharge, or death, whichever occurs first|Analysis is restricted to evaluable subjects (defined as randomized subjects who underwent cardiac surgery within 30 days after randomization and received at least one RBC transfusion between randomization and post-operative hour 96).||mg/dL||Standard Deviation|Mean
804602|NCT00991341|Secondary|Ventilation Duration|Because some subjects may experience multiple periods of ventilator use, the total duration that they were on a ventilator was compared between the two groups.|Through post-operative day 28, hospital discharge, or death, whichever occurs first|Analysis is restricted to evaluable subjects (defined as randomized subjects who underwent cardiac surgery within 30 days after randomization and received at least one RBC transfusion between randomization and post-operative hour 96).||days||Standard Deviation|Mean
804603|NCT00991341|Secondary|Composite of Major Pulmonary Events (Any Mechanical Ventilation From 48 Hours Post-operation to Day 7, Hospital Discharge or Death, Whichever Comes First, or Pulmonary Embolism)||Through post-operative day 7, hospital discharge, or death, whichever occurs first|Analysis is restricted to evaluable subjects (defined as randomized subjects who underwent cardiac surgery within 30 days after randomization and received at least one RBC transfusion between randomization and post-operative hour 96).||participants with event|||Number
804604|NCT00991341|Secondary|Composite of Major Cardiac Events (Death, Myocardial Infarction, Low Cardiac Output, Ventricular Tachycardia, Ventricular Fibrillation)||Through post-operative day 7, hospital discharge, or death, whichever occurs first|Analysis is restricted to evaluable subjects (defined as randomized subjects who underwent cardiac surgery within 30 days after randomization and received at least one RBC transfusion between randomization and post-operative hour 96).||participants with event|||Number
804605|NCT00991341|Secondary|Composite of Major In-hospital Post-operative Complications (Death, Stroke, Myocardial Infarction, Renal Failure, Culture-proven Sepsis/Septic Shock)||Through post-operative day 7, hospital discharge, or death, whichever occurs first|Analysis is restricted to evaluable subjects (defined as randomized subjects who underwent cardiac surgery within 30 days after randomization and received at least one RBC transfusion between randomization and post-operative hour 96).||participants with event|||Number
804606|NCT00991341|Secondary|Change in Multiple Organ Dysfunction Score From Pre-operative Baseline.|The follow-up MODS used to calculate 28-day ΔMODS from pre-op baseline was based on the worst value of each component of MODS observed through post-op day 28, hospital discharge, or death, whichever occurred first, even if a subject's worst values for different components occurred on different dates. Subjects who died during this time period were assigned the worst possible follow-up MODS score, 24 points, and each component of MODS was set at 4, which is the worst score. If a subject did not die during this time period but had at least one day where the Glasgow Coma Score couldn't be scored[subject sedated; neurologic function not normal by pre-op history (prior stroke, tumor or trauma sequelae, cognitively challenged, behavioral disorder, etc.) or intra-op history, but currently unable to assess because of sedation], then a post-op MODS score was set to missing and a 28-day ΔMODS was not computed. The total MODS score ranges from 0 (best possible) to 24 points (worst possible).|Through 28 days post-surgery, hospital discharge, or death, whichever occurs first|Analysis is restricted to evaluable subjects (defined as randomized subjects who underwent cardiac surgery within 30 days after randomization and received at least one RBC transfusion between randomization and post-operative hour 96).||MOD score points||Standard Deviation|Mean
804607|NCT00991341|Secondary|All-cause Mortality|Subjects were randomized for RECESS no earlier than one calendar day before the planned date of surgery, and were followed for all-cause mortality until post-operative Day 28, death, or study withdrawal, whichever occurred first. In some cases the surgery was postponed after randomization had already occurred. If surgery did not occur within 30 days after randomization, the subject ended the study and was not considered evaluable. If surgery did occur within 30 days after randomization, and the subject received at least one RBC transfusion between randomization and 96 hours after the end of surgery, the subject was considered evaluable. Therefore, in a few evaluable subjects, post-operative Day 28 could be nearly two months after the date of randomization. The times in the time-to-event analysis started at randomization.|28 days post-surgery|Analysis is restricted to evaluable subjects (defined as randomized subjects who underwent cardiac surgery within 30 days after randomization and received at least one RBC transfusion between randomization and post-operative hour 96).||participants with event|||Number
804618|NCT00991510|Primary|Maximum Observed Plasma Concentration (Cmax) of Mycophenolate Mofetil|Cmax was directly obtained from measured values of plasma concentrations.|Day 14 and Day 28 (end of first two cross-over periods) before drug administration and at 30 min, 1 hour, 1.5, 2, 3, 4, 5, 6, 8, 10, and 12 hours after drug administration|PK population. Two participants were excluded from the PK population: one dropped out of the study during the first period so had no PK samples. The other was omitted due to protocol violations.||µg /ml||Standard Deviation|Mean
804608|NCT00991341|Primary|The Change in the Composite Multiple Organ Dysfunction Score (MODS) From the Pre-operative Baseline. The Worst Post-operative Values of Each Component of MODS Will be Used to Calculate the Change in MODS.|The follow-up MODS used to calculate 7-day ΔMODS from pre-op baseline was based on the worst value of each component of MODS observed through post-op day 7, hospital discharge, or death, whichever occurred first, even if a subject’s worst values for different components occurred on different dates. Subjects who died during this time period were assigned the worst possible follow-up MODS score, 24 points, and each component of MODS was set at 4, which is the worst score. If a subject did not die during this time period but had at least one day where the Glasgow Coma Score couldn't be scored [subject sedated; neurologic function not normal by pre-op history (prior stroke, tumor or trauma sequelae, cognitively challenged, behavioral disorder, etc.) or intra-op history, but currently unable to assess because of sedation], then a post-op MODS score was set to missing and a 7-day ΔMODS was not computed. The total MODS score ranges from 0 (best possible) to 24 points (worst possible).|Through post-operative day 7, hospital discharge, or death, whichever occurs first|Analysis is restricted to evaluable subjects (defined as randomized subjects who underwent cardiac surgery within 30 days after randomization and received at least one RBC transfusion between randomization and post-operative hour 96).||MOD score points||Standard Deviation|Mean
804609|NCT00991458|Secondary|Worst Outcome Post-LASIK Surgery in Reading Speed Assessment|Reading speed is determined using the MNREAD™ Reading Card. The MNREAD™ reading card is designed to simulate a normal every day reading scenario using binocular vision (both eyes at the same time). The MNREAD™ Reading speed is calculated as (60) X [Number of words on card - (reading errors)]/ (number of seconds until the card is read). The worst outcome is defined as the smallest number of words per minute across post-LASIK surgery months 3 to 6.|Months 3 to 6|Intent to Treat population: all randomized patients for whom data are available for this outcome measure.||Words Per Minute (WPM)||Standard Deviation|Mean
804610|NCT00991458|Secondary|Percentage of Patients With Cumulative Poor Vision|Cumulative Poor Vision is determined binocularly per patient (using both eyes at the same time) from the Poor Vision question on the Ocular Surface Disease Index (OSDI) questionnaire. Severity of poor vision is graded on a 5-point scale (0 = none of the time, 1 = some of the time, 2 = half of the time, 3 = most of the time, 4 = all of the time). Cumulative poor vision is defined as at least one poor vision score ≥ 1 beginning at Month 3 post-LASIK.|Month 3, Month 4, Month 5, Month 6|Intent to treat: all randomized patients.||Percentage of Patients|||Number
804611|NCT00991458|Secondary|Time to Worst Outcome Post-LASIK Surgery in Tear Film Assessment|The time to the worst outcome post-LASIK surgery in tear film stability is assessed using the Ocular Scatter Index (OSI). The OSI is calculated by an instrument which takes images of the eye over time. OSI values ≥3.0 indicate lower tear film quality resulting in a loss of visual acuity. The worst outcome post-LASIK surgery is defined as the shortest time to OSI ≥3 across both eyes and post-LASIK surgery months 3 to 6.|Months 3 to 6|Intent to Treat population: all randomized patients for whom data are available for this outcome measure.||Seconds||Standard Deviation|Mean
804612|NCT00991458|Primary|Time to Cure|Time to cure is defined as the number of days after laser in situ keratomileusis (LASIK) surgery that the patient has corneal sensitivity (the capability of the cornea to respond to stimulation) ≥ 50 millimeters in all 9 regions of both eyes after LASIK surgery. A patient is considered cured at the first of 2 consecutive visits meeting these criteria. The Inter-Quartile Range presented is actually the 25th Quantile and the 75th Quantile obtained from the Kaplan-Meier Model.|6 Months|Modified Intent to Treat: all randomized and treated patients with both eyes having Post-LASIK surgery and corneal sensitivity measurements of < 25 mm in the 3 central regions at Post-Surgery Week 1.||Days||Inter-Quartile Range|Median
804613|NCT00991510|Secondary|Summary of Participants With Adverse Events|"Summary of adverse events across three study time periods. The on-treatment time frame spanned the time during which study drug was administered. Relation to study drug was assessed by the investigator.
The Adverse Event count includes serious and non-serious AEs. A serious AE (SAE) was any event that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity or congenital anomaly/birth defect or was an important medical event could have jeopardized the patient's safety or required medical or surgical intervention to prevent one of the outcomes listed above.
Severity was measured on a three-point scale: mild, moderate, severe."|Day 1 up to Day 112|Safety population. One participant discontinued the study prior to Period II so the Myfenax # participants analyzed is one less than the CellCept arm.||participants|||Number
804614|NCT00991510|Secondary|Time Corresponding to Occurrence of Cmax (Tmax) of Mycophenolate Mofetil|Tmax was directly obtained from measured values.|Day 14 and Day 28 (end of first two cross-over periods) before drug administration|PK population. Two participants were excluded from the PK population: one dropped out of the study during the first period so had no PK samples. The other was omitted due to protocol violations.||hours||Standard Deviation|Mean
804615|NCT00991510|Secondary|Degree of Fluctuation of the Concentration Levels of Mycophenolate Mofetil Over One Dosing Interval (PTF)|PTF was calculated as: (Cmax-Cmin)/(AUCt/t)*100|Day 14 and Day 28 (end of first two cross-over periods) before drug administration|PK population. Two participants were excluded from the PK population: one dropped out of the study during the first period so had no PK samples. The other was omitted due to protocol violations.||percentage of AUC for a dosing interval||Standard Deviation|Mean
804616|NCT00991510|Secondary|Plasma Concentrations of Mycophenolate Mofetil in Pre-Administration Samples (Cpd)|Cpd was directly obtained from measured values of plasma concentrations.|Day 14 and Day 28 (end of first two cross-over periods) before drug administration|PK population. Two participants were excluded from the PK population: one dropped out of the study during the first period so had no PK samples. The other was omitted due to protocol violations.||µg /ml||Standard Deviation|Mean
804617|NCT00991510|Secondary|Minimum Observed Plasma Concentration (Cmin) of Mycophenolate Mofetil|Cmin was directly obtained from measured values of plasma concentrations.|Day 14 and Day 28 (end of first two cross-over periods) before drug administration and at 30 min, 1 hour, 1.5, 2, 3, 4, 5, 6, 8, 10, and 12 hours after drug administration|PK population. Two participants were excluded from the PK population: one dropped out of the study during the first period so had no PK samples. The other was omitted due to protocol violations.||µg /ml||Standard Deviation|Mean
806266|NCT01012167|Secondary|Laboratory Measures - Cholesterol|Total cholesterol blood levels by treatment group and visit.|Once during evaluation and once at the end of 6 weeks of study treatment|Available participant lab data for Evaluation and Week 6.||mg/dL||Standard Deviation|Mean
804619|NCT00991510|Primary|Area Under the Plasma Concentration-time Curve (AUC(0-tau)) of Mycophenolate Mofetil|For participants with a 0-12h profile: Area under the plasma concentration-time curve during a dosage interval at steady state (calculated using the trapezoidal rule, from t = 0 to t = 12 hours). For participants with a 0-6h profile: AUC(0-tau) was calculated based on AUC(0-6h) using the extrapolation formula according to Fleming.|Day 14 and Day 28 (end of first two cross-over periods) before drug administration and at 30 min, 1 hour, 1.5, 2, 3, 4, 5, 6, 8, 10, and 12 hours after drug administration|PK population. Two participants were excluded from the PK population: one dropped out of the study during the first period so had no PK samples. The other was omitted due to protocol violations.||hour* µg /ml||Standard Deviation|Mean
804620|NCT00991510|Primary|Area Under the Plasma Concentration-time Curve (AUC(0-6h)) of Mycophenolate Mofetil|Area under the plasma concentration-time curve during a dosage interval at steady state (calculated using the trapezoidal rule, from t = 0 to t = 6 hours).|Day 14 and Day 28 (end of first two cross-over periods) before drug administration and at 30 min, 1 hour, 1.5, 2, 3, 4, 5, 6, 8, 10, and 12 hours after drug administration|PK population. Two participants were excluded from the PK population: one dropped out of the study during the first period so had no PK samples. The other was omitted due to protocol violations.||hour* µg /ml||Standard Deviation|Mean
804621|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Epithelial Cells – 4 Weeks After Last Dose, Post Allergen Challenge||4 weeks after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||10^6 cells/g||Full Range|Geometric Mean
804622|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Epithelial Cells – 4 Weeks After Last Dose, Pre Allergen Challenge||4 weeks after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||10^6 cells/g||Full Range|Geometric Mean
804623|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Epithelial Cells – 1 Week After Last Dose, Post Allergen Challenge||1 week after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||10^6 cells/g||Full Range|Geometric Mean
804624|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Epithelial Cells – 1 Week After Last Dose, Pre Allergen Challenge||1 week after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||10^6 cells/g||Full Range|Geometric Mean
804625|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Epithelial Cells – Pre-treatment, Post Allergen Challenge||Pre-treatment, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||10^6 cells/g||Full Range|Geometric Mean
804626|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Epithelial Cells – Pre-treatment, Pre Allergen Challenge||Pre-treatment, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||10^6 cells/g||Full Range|Geometric Mean
804627|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Lymphocytes – 4 Weeks After Last Dose, Post Allergen Challenge||4 weeks after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||10^6 cells/g||Full Range|Geometric Mean
804628|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Lymphocytes – 4 Weeks After Last Dose, Pre Allergen Challenge||4 weeks after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||10^6 cells/g||Full Range|Geometric Mean
804629|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Lymphocytes – 1 Week After Last Dose, Post Allergen Challenge||1 week after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||10^6 cells/g||Full Range|Geometric Mean
804630|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Lymphocytes – 1 Week After Last Dose, Pre Allergen Challenge||1 week after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||10^6 cells/g||Full Range|Geometric Mean
804631|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Lymphocytes – Pre-treatment, Post Allergen Challenge||Pre-treatment, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||10^6 cells/g||Full Range|Geometric Mean
810709|NCT01048606|Secondary|Maximal Oxygen Uptake Measured Using a Continuous, Incremental Protocol (Balke Modified Protocol) on a Treadmill With a Breathing Mask by Indirect Calorimetry (CCM/D, Medgraphics Corp, St-Paul, MN, USA).||0 and 12 months||||||
804632|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Lymphocytes – Pre-treatment, Pre Allergen Challenge||Pre-treatment, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||10^6 cells/g||Full Range|Geometric Mean
804633|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Macrophages – 4 Weeks After Last Dose, Post Allergen Challenge||4 weeks after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||10^6 cells/g||Full Range|Geometric Mean
804634|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Macrophages – 4 Weeks After Last Dose, Pre Allergen Challenge||4 weeks after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||10^6 cells/g||Full Range|Geometric Mean
804635|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Macrophages – 1 Week After Last Dose, Post Allergen Challenge||1 week after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||10^6 cells/g||Full Range|Geometric Mean
804636|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Macrophages – 1 Week After Last Dose, Pre Allergen Challenge||1 week after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||10^6 cells/g||Full Range|Geometric Mean
804637|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Macrophages – Pre-treatment, Post Allergen Challenge||Pre-treatment, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||10^6 cells/g||Full Range|Geometric Mean
804638|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Macrophages – Pre-treatment, Pre Allergen Challenge||Pre-treatment, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||10^6 cells/g||Full Range|Geometric Mean
804639|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Neutrophils – 4 Weeks After Last Dose, Post Allergen Challenge||4 weeks after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||10^6 cells/g||Full Range|Geometric Mean
804640|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Neutrophils – 4 Weeks After Last Dose, Pre Allergen Challenge||4 weeks after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||10^6 cells/g||Full Range|Geometric Mean
804641|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Neutrophils – 1 Week After Last Dose, Post Allergen Challenge||1 week after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||10^6 cells/g||Full Range|Geometric Mean
804642|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Neutrophils – 1 Week After Last Dose, Pre Allergen Challenge||1 week after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||10^6 cells/g||Full Range|Geometric Mean
804643|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Neutrophils – Pre-treatment, Post Allergen Challenge||Pre-treatment, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||10^6 cells/g||Full Range|Geometric Mean
804644|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Neutrophils – Pre-treatment, Pre Allergen Challenge||Pre-treatment, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||10^6 cells/g||Full Range|Geometric Mean
804645|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Eosinophils – 4 Weeks After Last Dose, Post Allergen Challenge||4 weeks after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||10^6 cells/g||Full Range|Geometric Mean
815830|NCT01102374|Primary|Number of Acute Respiratory Infections (ARIs)|ARIs defined as upper or lower respiratory infections|12 months|||events|||Number
804646|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Eosinophils – 4 Weeks After Last Dose, Pre Allergen Challenge||4 weeks after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||10^6 cells/g||Full Range|Geometric Mean
804647|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Eosinophils – 1 Week After Last Dose, Post Allergen Challenge||1 week after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||10^6 cells/g||Full Range|Geometric Mean
804648|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Eosinophils – 1 Week After Last Dose, Pre Allergen Challenge||1 week after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||10^6 cells/g||Full Range|Geometric Mean
804649|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Eosinophils – Pre-treatment, Post Allergen Challenge||Pre-treatment, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||10^6 cells/g||Full Range|Geometric Mean
804650|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Eosinophils – Pre-treatment, Pre Allergen Challenge||Pre-treatment, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||10^6 cells/g||Full Range|Geometric Mean
804651|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Total Cells/g – 4 Weeks After Last Dose, Post Allergen Challenge||4 weeks after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||Cell count/g||Full Range|Geometric Mean
804652|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Total Cells/g – 4 Weeks After Last Dose, Pre Allergen Challenge||4 weeks after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||Cell count/g||Full Range|Geometric Mean
804653|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Total Cells/g – 1 Week After Last Dose, Post Allergen Challenge||1 week after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||Cell count/g||Full Range|Geometric Mean
804654|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Total Cells/g – 1 Week After Last Dose, Pre Allergen Challenge||1 week after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||Cell count/g||Full Range|Geometric Mean
804655|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Total Cells/g – Pre-treatment, Post Allergen Challenge||Pre-treatment, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||Cell count/g||Full Range|Geometric Mean
804656|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Total Cells/g – Pre-treatment, Pre Allergen Challenge||Pre-treatment, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||Cell count/g||Full Range|Geometric Mean
804657|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-13 – 4 Weeks After Last Dose, Post Allergen Challenge||4 weeks after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
804658|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-13 – 4 Weeks After Last Dose, Pre Allergen Challenge||4 weeks after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
804659|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-13 – 1 Week After Last Dose, Post Allergen Challenge||1 week after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
819715|NCT01130597|Primary|Percentage of Participants With Serum Potassium in the Range of 3.5 - 5.5 mEq/L at the End of Treatment||56 days|||percentage of participants|||Number
804660|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-13 – 1 Week After Last Dose, Pre Allergen Challenge||1 week after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
804661|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-13 – Pre-treatment, Post Allergen Challenge||Pre-treatment, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
804662|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Interleukin-13 (IL-13) – Pre-treatment, Pre Allergen Challenge||Pre-treatment, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
804663|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-10 – 4 Weeks After Last Dose, Post Allergen Challenge||4 weeks after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
804664|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-10 – 4 Weeks After Last Dose, Pre Allergen Challenge||4 weeks after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
804665|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-10 – 1 Week After Last Dose, Post Allergen Challenge||1 week after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
804666|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-10 – 1 Week After Last Dose, Pre Allergen Challenge||1 week after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
804667|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-10 – Pre-treatment, Post Allergen Challenge||Pre-treatment, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
804668|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Interleukin-10 (IL-10) – Pre-treatment, Pre Allergen Challenge||Pre-treatment, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
804669|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-8 – 4 Weeks After Last Dose, Post Allergen Challenge||4 weeks after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
804670|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-8 – 4 Weeks After Last Dose, Pre Allergen Challenge||4 weeks after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
804671|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-8 – 1 Week After Last Dose, Post Allergen Challenge||1 week after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
804672|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-8 – 1 Week After Last Dose, Pre Allergen Challenge||1 week after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
804673|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-8 – Pre-treatment, Post Allergen Challenge||Pre-treatment, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
805178|NCT00995566|Primary|Clinical Status Since Last Visit|Clinical status determined by status of pulmonary arterial hypertension (PAH) since last visit, reported as PAH remained stable, improved or deteriorated.|Monthly up to 1 year|Data not summarized due to the small number of participants in database.||participants|||Number
804674|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Interleukin-8 (IL-8) – Pre-treatment, Pre Allergen Challenge||Pre-treatment, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
804675|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-6 – 4 Weeks After Last Dose, Post Allergen Challenge||4 weeks after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
804676|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-6 – 4 Weeks After Last Dose, Pre Allergen Challenge||4 weeks after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
804677|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-6 – 1 Week After Last Dose, Post Allergen Challenge||1 week after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
804678|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-6 – 1 Week After Last Dose, Pre Allergen Challenge||1 week after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
804679|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-6 – Pre-treatment, Post Allergen Challenge||Pre-treatment, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
804680|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Interleukin-6 (IL-6) – Pre-treatment, Pre Allergen Challenge||Pre-treatment, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
804681|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-5 – 4 Weeks After Last Dose, Post Allergen Challenge||4 weeks after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
804682|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-5 – 4 Weeks After Last Dose, Pre Allergen Challenge||4 weeks after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
804683|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-5 – 1 Week After Last Dose, Post Allergen Challenge||1 week after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
804684|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-5 – 1 Week After Last Dose, Pre Allergen Challenge||1 week after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
804685|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-5 – Pre-treatment, Post Allergen Challenge||Pre-treatment, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
804686|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Interleukin-5 (IL-5) – Pre-treatment, Pre Allergen Challenge||Pre-treatment, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
804687|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-1β – 4 Weeks After Last Dose, Post Allergen Challenge||4 weeks after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
805507|NCT01003899|Secondary|Progression Free Survival (PFS) Time|PFS time is defined as time from start of treatment to the earliest of progression (RECIST version 1.1), clinical progression (investigator), start of new anti-cancer treatment or death|Baseline till end of study or death|FAS - Full Analysis Set||Weeks||95% Confidence Interval|Median
804688|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-1β – 4 Weeks After Last Dose, Pre Allergen Challenge||4 weeks after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
804689|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-1β – 1 Week After Last Dose, Post Allergen Challenge||1 week after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
804690|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-1β – 1 Week After Last Dose, Pre Allergen Challenge||1 week after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
804691|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-1β – Pre-treatment, Post Allergen Challenge||Pre-treatment, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
804692|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Interleukin-1β (IL-1β) – Pre-treatment, Pre Allergen Challenge||Pre-treatment, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
804693|NCT00999466|Secondary|Sputum Cellularity and Cytokines, TNFα – 4 Weeks After Last Dose, Post Allergen Challenge||4 weeks after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
804694|NCT00999466|Secondary|Sputum Cellularity and Cytokines, TNFα – 4 Weeks After Last Dose, Pre Allergen Challenge||4 weeks after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
804695|NCT00999466|Secondary|Sputum Cellularity and Cytokines, TNFα – 1 Week After Last Dose, Post Allergen Challenge||1 week after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
804696|NCT00999466|Secondary|Sputum Cellularity and Cytokines, TNFα – 1 Week After Last Dose, Pre Allergen Challenge||1 week after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
804697|NCT00999466|Secondary|Sputum Cellularity and Cytokines, TNFα – Pre-treatment, Post Allergen Challenge||Pre-treatment, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
804698|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Tumour Necrosis Factor Alpha (TNFα) – Pre-treatment, Pre Allergen Challenge||Pre-treatment, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
804699|NCT00999466|Secondary|PC20 Methacholine Challenge – 4 Weeks After Last Dose, Post Allergen Challenge|PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1|4 weeks after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||mg/mL||Full Range|Geometric Mean
804700|NCT00999466|Secondary|PC20 Methacholine Challenge – 4 Weeks After Last Dose, Pre Allergen Challenge|PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1|4 weeks after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||mg/mL||Full Range|Geometric Mean
804701|NCT00999466|Secondary|PC20 Methacholine Challenge – 1 Week After Last Dose, Post Allergen Challenge|PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1|1 week after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||mg/mL||Full Range|Geometric Mean
804702|NCT00999466|Secondary|PC20 Methacholine Challenge – 1 Week After Last Dose, Pre Allergen Challenge|PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1|1 week after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||mg/mL||Full Range|Geometric Mean
804703|NCT00999466|Secondary|PC20 Methacholine Challenge – Pre-treatment, Post Allergen Challenge|PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1|Pre-treatment, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||mg/mL||Full Range|Geometric Mean
804704|NCT00999466|Secondary|PC20 Methacholine Challenge – Pre-treatment, Pre Allergen Challenge|PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1|Pre-treatment, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||mg/mL||Full Range|Geometric Mean
804705|NCT00999466|Secondary|FEV1, Early Asthmatic Response (EAR) – 4 Weeks After Last Dose|FEV1, Early Asthmatic Response (EAR), is derived as the ratio of FEV1 AUC 0-2h (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.|4 weeks after last dose|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||ratio||Standard Deviation|Mean
804706|NCT00999466|Secondary|FEV1, Early Asthmatic Response (EAR) – 1 Week After Last Dose|FEV1, Early Asthmatic Response (EAR), is derived as the ratio of FEV1 AUC 0-2h (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.|1 week after last dose|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||ratio||Standard Deviation|Mean
804707|NCT00999466|Secondary|FEV1, Early Asthmatic Response (EAR) – Pre-treatment|FEV1, Early Asthmatic Response (EAR), is derived as the ratio of FEV1 Area Under Curve 0-2 hour post allergen challenge (AUC 0-2h) (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.|Pre-treatment (Baseline measurement)|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||ratio||Standard Deviation|Mean
804708|NCT00999466|Primary|FEV1, Late Asthmatic Response (LAR) – 4 Weeks After Last Dose|FEV1, Late Asthmatic Response (LAR), is derived as the ratio of FEV1 AUC 4-10h (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.|4 weeks after last dose|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||ratio||Standard Deviation|Mean
804709|NCT00999466|Primary|FEV1, Late Asthmatic Response (LAR) – 1 Week After Last Dose|FEV1, Late Asthmatic Response (LAR), is derived as the ratio of FEV1 AUC 4-10h (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.|1 week after last dose|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||ratio||Standard Deviation|Mean
804710|NCT00999466|Primary|FEV1, Late Asthmatic Response (LAR) – Pre-treatment|Forced Expiratory Volume in 1 second (FEV1), Late Asthmatic Response (LAR), is derived as the ratio of FEV1 Area Under Curve 4-10 hour post allergen challenge (AUC 4-10h) (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.|Pre-treatment (Baseline measurement)|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||ratio||Standard Deviation|Mean
804711|NCT00999544|Secondary|Respiration Depression|Respiration rate measured over 60 seconds. Data were collected across multiple time points, but the peak minimum score was used for this outcome measure.|42 days|Prior laboratory-based within subject studies of the pharmacodynamic response to opioid challenges.||number of breaths per minute||Standard Deviation|Mean
804712|NCT00999544|Primary|Abuse Liability Proxy|"Visual analog scale ratings (from 0-100) on the subject-rated measure of How much do you like the drug? with higher scores indicating greater abuse liability (and 100 anchored with extremely and zero indicating none anchored with none at all. Data were collected across multiple time points but the peak maximum score was used for the primary outcome measure."|42 days|Prior laboratory-based within subject studies of the pharmacodynamic response to opioid challenges. The within subject data analysis does not lend itself to reporting data in the format provided below.||units on a scale (points 0-100)||Standard Deviation|Mean
804713|NCT00999596|Primary|FFDM (Full Field Digital Mammography) Mammogram Scores|6 mammography image sets (4 images per set) from women participating in the study were read and rated (pass/fail) by 2 MQSA (Mammorgraphy Quality Standards Act) certified mammography readers. A typical MQSA evaluation was performed on each image set and an image set was scored Pass or Fail. A total of 12 scores (6 image sets, 2 readers) were obtained.|Day 1|This was not a statistical sample per FDA FFDM Guideline. FDA Guideline specified that a minimum of 6 film sets from the participants be analyzed. The number of participants required by FDA changed mid-study.||FFDM Mammogram set|||Number
837709|NCT01307631|Secondary|Duration of Progression-free Survival|Estimated by using Kaplan-Meier analysis.|Up to 3 years|||months||90% Confidence Interval|Median
804714|NCT01000610|Secondary|Change in Bone Density (in Participants Untreated With Bisphosphonates)|Bone mineral density test was performed using x-ray radiation and the values of bone density were provided directly by the apparatus as grams per square centimeter (g/cm^2) . T-score is the number of standard deviations above or below the mean for a healthy 30 year old adult of the same sex and ethnicity as the participant. A T-score with above -1 is normal bone density level. A T-score between -1 and -2.5 means that the bone density is below normal and it might be a sign of an osteopenia and may also lead into osteoporosis. A T-score below -2.5 indicates osteoporosis.|Screening and Week 84|ITT population; only participants with an assessment at both screening and Week 84 were included in the analysis.||t-score|||Number
804715|NCT01000610|Secondary|Percentage of Participants Whose DAS28 Improved by >1.2 at Week 24|The DAS28 score is a measure of the participant's disease activity calculated using the TJC [28 joints], SJC [28 joints], participant's global assessment of disease activity [VAS: 0 = no disease activity to 100 = maximum disease activity] and the ESR for a total possible score of 0 to 10. Scores < 2.6 indicate best disease control and scores ≥ 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score < 2.6. An improvement of >1.2 was considered to be clinically significant improvement.|Baseline and Week 24|ITT population; Only participants with DAS28 values at both Baseline and Week 24 were included in the analysis.||percentage of participants|||Number
804716|NCT01000610|Secondary|Percentage Change in Disease Activity Score 28 (DAS28) From Baseline to Week 24|The DAS28 score is a measure of the participant's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], participant's global assessment of disease activity [visual analog scale: [VAS] 0 equals (=) no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to 10. Scores less than (<) 2.6 indicate best disease control and scores greater than or equal to (≥) 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score < 2.6. The average improvement at each visit to the group score is equal to the formula (Previous DAS28 minus [-] current DAS 28)/ Previous DAS 28 x 100. Negative percentages indicate that the participant has worsened in comparison to last evaluation, and positive percentages indicate improvement of its DAS28 score and correlated with a bettering of clinical situation.|Baseline and Week 24|ITT population; Only participants with DAS28 values at both Baseline and Week 24 were included in the analysis.||percentage change from baseline||Standard Deviation|Mean
804717|NCT01000610|Primary|Number of Participants Reporting Adverse Events (AEs)||Days 1 and 15, every 8 weeks up to Week 24 and and then every 3 months up to 18 months for a total of 104 weeks|Safety Population: Included all participants who have received any part of an infusion of study medication.||number of participants|||Number
804718|NCT01000649|Secondary|Incidence of Abnormal Changes in ECG|"The number of patients having abnormal changes in ECG variables during the trial period was presented.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|Day 1 up to Day 7|The analysis population consist of Safety Analysis Set, which comprised of all patients who were dosed.||Number of patients|||Number
804719|NCT01000649|Secondary|Mortality|"Mortality was assessed as percentage of patients dead at pre-specified time points.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|At Day 1, 7, 14, and 28|The analysis population consist of FAS, which comprised of all patients who were dosed.||Percentage of patients|||Number
804720|NCT01000649|Secondary|Percentage of Days Alive and Free of Ventilation|"Percentage of days alive and free of ventilation was assessed on Days 7, 14, and 28.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|At Day 7|The analysis population consist of FAS, which comprised of all patients who were dosed.||Percentage of days||Standard Deviation|Mean
804721|NCT01000649|Secondary|Percentage of Days Alive and Free of Dialysis|"Percentage of days alive and free of dialysis was assessed on Days 7, 14, and 28.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|At Day 7, Day 14 and Day 28|The analysis population consist of FAS, which comprised of all patients who were dosed.||Percentage of days||Standard Deviation|Mean
804722|NCT01000649|Secondary|Percentage of Patients Alive and Free of All Vasopressors|"Percentage of patients alive and free of all vasopressors was assessed on Days 7, 14, and 28.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|At Day 7, Day 14 and Day 28|The analysis population consist of FAS, which comprised of all patients who were dosed.||Percentage of patients|||Number
804723|NCT01000649|Secondary|Days Alive and Free of Any Organ Dysfunction at Day 7|"Percentage of days alive and free of any organ dysfunction (i.e. no. of days divided by 7).
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|At Day 7|The analysis population consist of FAS, which comprised of all patients who were dosed.||Percentage of days||Standard Deviation|Mean
804724|NCT01000649|Secondary|Change From Baseline in Arterial Blood Gas (Lactate)|"Change from Baseline in arterial blood gas (lactate) was observed at each time-point.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|Day 1 up to Day 7|The analysis population consist of Safety Analysis Set, which comprised of all patients who were dosed.||mmol/L||Standard Deviation|Mean
804725|NCT01000649|Secondary|Pulmonary Function : Change From Baseline in Tidal Volume|"Change from Baseline in tidal volume was observed at each time-point.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|Day 1 up to Day 7|The analysis population consist of Safety Analysis Set, which comprised of all patients who were dosed.||mL/kg||Standard Deviation|Mean
805508|NCT01003899|Secondary|Percentage of Participants With Disease Control (DC)|Percentage of participants with objective response or stable disease (SD) as determined by RECIST version 1.1.|Baseline till progression or death|FAS - Full Analysis Set||Percentage of participants||95% Confidence Interval|Number
804726|NCT01000649|Secondary|Pulmonary Function : Change From Baseline in PaO2/FiO2|"Change from Baseline in PaO2/FiO2 was observed at each time-point.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|Day 1 up to Day 7|The analysis population consist of Safety Analysis Set, which comprised of all patients who were dosed.||Ratio||Standard Deviation|Mean
804727|NCT01000649|Secondary|SOFA Score|"The SOFA score, is used to track a patient's status during the stay in an intensive care unit. This scoring system is used to determine the extent of a person's organ function or rate of failure. The scoring system comprise of scores for six different system: Respiratory System; Nervous System; Cardiovascular System; Liver; Coagulation; and Renal System. Score for each system ranges from 0-4 (0=normal, 4=worst).
Total SOFA score is a sum of the individual system score and range from 0 to 24, 0 being the better and 24 being the worst patient status.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|Day 1 up to Day 7, Day 14 and Day 29|The analysis population consist of FAS, which comprised of all patients who were dosed.||Score on a scale||Standard Deviation|Mean
804728|NCT01000649|Secondary|Change From Baseline in Fluid Balance|"The change from Baseline in fluid balance were analysed and presented as per the planned time points. The fluid balance was adjusted for length of time interval and weight.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|Day 1 up to Day 7|The analysis population consist of FAS, which comprised of all patients who were dosed.||mL/hour/kg||Standard Deviation|Mean
804729|NCT01000649|Secondary|Change From Baseline in Heart Rate|"The change from Baseline in heart rate was analysed and presented as per the planned time points.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|Day 1 up to Day 7|The analysis population consist of Safety Analysis Set, which comprised of all patients who were dosed.||Beats per minute||Standard Deviation|Mean
804730|NCT01000649|Secondary|Change From Baseline in Interleukin-1 Receptor (IL-1R) Antagonist|"The change from Baseline in IL-1R levels were analysed and presented as per the planned time points.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|At Day 1, Day 2, Day 4, and Day 7|The analysis population consist of FAS, which comprised of all patients who were dosed.||µg/L||Standard Deviation|Mean
804731|NCT01000649|Primary|Infusion Rates of Open Label NE.|"Mean open label NE infusion rate within each predefined time period.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|Day 1 up to Day 7|The analysis population consist of FAS, which comprised of all patients who were dosed.||µg/kg/min||Standard Deviation|Mean
804732|NCT01000649|Secondary|Change From Baseline in Interleukin-10 (IL-10)|"The change from Baseline in IL-10 levels were analysed and presented as per the planned time points.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|At Day 1, Day 2, Day 4, and Day 7|The analysis population consist of FAS, which comprised of all patients who were dosed.||ng/L||Standard Deviation|Mean
804733|NCT01000649|Secondary|Change From Baseline in Interleukin-6 (IL-6)|"The change from Baseline in IL-6 levels were analysed and presented as per the planned time points.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|At Day 1, Day 2, Day 4, and Day 7|The analysis population consist of FAS, which comprised of all patients who were dosed.||ng/L||Standard Deviation|Mean
804734|NCT01000649|Secondary|Change From Baseline in Tumor Necrosis Factor (TNF)-Alpha|"The change from Baseline in TNF-alpha levels were analysed and presented as per the planned time points.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|At Day 1, Day 2, Day 4, and Day 7|The analysis population consist of FAS, which comprised of all patients who were dosed.||ng/L||Standard Deviation|Mean
804735|NCT01000649|Secondary|Change From Baseline in C-reactive Protein (CRP)|"The change from Baseline in CRP levels were analysed and presented as per the planned time points.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|Day 1 up to Day 7|The analysis population consist of FAS, which comprised of all patients who were dosed.||mg/L||Standard Deviation|Mean
804736|NCT01000649|Secondary|PK Parameter in Patients : Terminal Elimination Half-life|"PK parameters were calculated using nonlinear 2-compartment population PK model with random patient effects on clearance and volume of distribution.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|Day 1 up to Day 7|The analysis population consist of FAS, which comprised of all patients who were dosed.||Hour||Standard Deviation|Mean
804737|NCT01000649|Secondary|PK Parameter in Patients : Initial Elimination Half-life|"PK parameters were calculated using nonlinear 2-compartment population PK model with random patient effects on clearance and volume of distribution.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|Day 1 up to Day 7|The analysis population consist of FAS, which comprised of all patients who were dosed.||Hour||Standard Deviation|Mean
804738|NCT01000649|Secondary|PK Parameter in Patients : Steady State Volume of Distribution|"PK parameters were calculated using nonlinear 2-compartment population PK model with random patient effects on clearance and volume of distribution.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|Day 1 up to Day 7|The analysis population consist of FAS, which comprised of all patients who were dosed.||Litre||Standard Deviation|Mean
804739|NCT01000649|Secondary|PK Parameter in Patients : Clearance|"PK parameters were calculated using nonlinear 2-compartment population PK model with random patient effects on clearance and volume of distribution.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|Day 1 up to Day 7|The analysis population consist of FAS, which comprised of all patients who were dosed.||Litre/hour||Standard Deviation|Mean
804740|NCT01000649|Secondary|PK Parameter in Patients : Time to Steady State|"PK parameters were calculated using nonlinear 2-compartment population PK model with random patient effects on clearance and volume of distribution.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|Day 1 up to Day 7|The analysis population consist of FAS, which comprised of all patients who were dosed.||Hour||Standard Deviation|Mean
804741|NCT01000649|Secondary|Pharmacokinetic (PK) Parameter in Patients : Steady State Concentration|"PK parameters were calculated using nonlinear 2-compartment population PK model with random patient effects on clearance and volume of distribution.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|Day 1 up to Day 7|The analysis population consist of FAS, which comprised of all patients who were dosed.||ng/mL||Standard Deviation|Mean
804742|NCT01000649|Primary|Cumulative Dose of Open Label NE.|"Cumulative Dose of Open Label NE over 7 days.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|Day 1 up to Day 7|The analysis population consist of Full Analysis Set, which comprised of all patients who were dosed.||µg/kg||Standard Deviation|Mean
804743|NCT01000649|Primary|Proportion of Patients Maintaining Target MAP (>60) Irrespective of Open Label NE|"Data were evaluated for target MAP of ≥ 60 mmHg. A 95% confidence interval (CI) was calculated and presented using Clopper-Pearson method.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|Day 1 up to Day 7|The analysis population consist of Full Analysis Set, which comprised of all patients who were dosed.||Percentage of patients||95% Confidence Interval|Number
804744|NCT01000649|Primary|Proportion of Patients Maintaining Target Mean Arterial Pressure (MAP) (>60 mmHg) With no Open Label NE (Norepinephrine)|"Data were evaluated for target MAP of ≥ 60 mmHg. A 95% confidence interval (CI) was calculated and presented using Clopper-Pearson method.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|Day 1 up to Day 7|The analysis population consist of Full Analysis Set, which comprised of all patients who were dosed.||Percentage of patients||95% Confidence Interval|Number
804745|NCT01000662|Secondary|Late Radiation Toxicities Recorded According to LENT/SOMA||yearly for five years after completion of treatment||||||
804746|NCT01000662|Secondary|QOL (Quality of Life) Questionnaire of Patients on the 2 Different Arms of Treatment||at baseline, at the end of last week of treatment, and at 2 year Follow-up||||||
804747|NCT01000662|Primary|Acute Radiation Toxicities Recorded According to Radiation Therapy Oncology Group (RTOG)|Proportion of patients with a grade 2 or greater toxicity after 3 weeks of whole breast IMRT with a once/week boost compared to those patients treated with a daily boost: 0 - no symptoms, 5 - death directly related to radiation effects|Day 1 of radiation treatment to day 60|Patients receiving either daily or weekly boost to radiation therapy||participants|||Number
804748|NCT01000727|Secondary|Number of Participants With All-cause Mortality During the Time Period for Vital Status|Number of participants who died, during the vital status time-period were reported. The participants who were known to have died, date of death was used; for participants who completed the study the study completion date was used; for participants who withdrew from the study where vital status was ascertained , and are known to have not died , the last known date to be alive was used and for participants whom vital status was not ascertained, following study withdrawal the study withdrawal date was used.|From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)|All-Randomized ITT Population||Participants|||Count of Participants
804749|NCT01000727|Secondary|Number of Participants With First Occurrence of Any Event in the Composite of CHD Death and Non-fatal MI During the Time Period for Follow-up of Cardiovascular Events|Acute MI is defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI. CHD death is defined as the occurrence of a fatal MI, death caused by documented cardiac arrest, death resulting from heart failure in a participant with known CHD, death from other forms of acute/chronic CHD, unwitnessed death of unknown origin, or sudden death.|From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)|All-Randomized ITT Population||Participants|||Count of Participants
804750|NCT01000727|Secondary|Number of Participants With First Occurrence of Any Component of the Composite of All-cause Mortality, Non-fatal MI, or Nonfatal Stroke During the Time Period for Follow-up of Cardiovascular Events|Acute MI is defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI. Stroke=presence of a new focal neurologic deficit thought to be of vascular origin, with signs/symptoms lasting >24 hours or results in death (in <24 hours).|From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)|All-Randomized ITT Population||Participants|||Count of Participants
805528|NCT01004159|Secondary|Response Rate of Cetuximab 500mg/m2/Week in Combination With Irinotecan in the Enrolled Patient Population||18 months|All treated and eligible patients||percentage of particitpants||95% Confidence Interval|Number
804751|NCT01000727|Secondary|Number of Participants With First Occurrence of Any Coronary Revascularization Procedures (Excluding Coronary Revascularization Planned Prior to Randomization, But Performed After Randomization) During the Time Period for Follow-up of Cardiovascular Event|All coronary revascularization procedures (except for PCI planned prior to randomization but performed after randomization) are included. Examples include coronary artery bypass graft, balloon angioplasty and stenting. The number of participants, with first occurrence of any coronary revascularization procedures, were reported.|From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)|All-Randomized ITT Population||Participants|||Count of Participants
804752|NCT01000727|Secondary|Number of Participants With First Occurrence of Any Event in the Composite of Total Coronary Events (CHD Death, Non-fatal MI, Hospitalization for Unstable Angina, or Any Coronary Revascularization Procedure) During the Time Period for FU of CV Events|CHD death, acute MI, and prior MI diagnosed post-randomization are defined in the primary endpoint (major coronary events). Hospitalization for unstable angina=one of the following, but not fulfilling the criteria for MI: ischemic discomfort at rest associated with electrocardiogram (ECG) changes leading to hospitalization; ischemic discomfort at rest regardless of ECG changes leading to hospitalization and revascularization during the same admission; ischemic discomfort at rest in hospital associated with ECG changes; ischemic discomfort at rest in hospital without ECG changes resulting in revascularization during the same admission. NOTE: The event was not considered to be unstable angina if, after invasive/non-invasive testing or other diagnostic testing, the discomfort was found not to be caused by myocardial ischemia. Coronary revascularization procedures exclude PCI planned prior to randomization but performed after randomization.|From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)|All-Randomized ITT Population||Participants|||Count of Participants
804753|NCT01000727|Secondary|Number of Participants With Urgent Coronary Revascularization for Myocardial Ischemia During the Time Period for Follow-up of Cardiovascular Events|Urgent coronary revascularization for myocardial ischemia is defined as ischemic discomfort at rest that prompts coronary revascularization (PCI or coronary artery bypass graft [CABG]) during the same hospitalization or resulting in hospital transfer for the purpose of coronary revascularization. PCI is defined as any attempt at revascularization even if not successful (e.g., angioplasty, atherectomy or stenting).|From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)|All-Randomized ITT Population||Participants|||Count of Participants
804754|NCT01000727|Secondary|Number of Participants With CHD Death During the Time Period for Follow-up of Cardiovascular Events|CHD death is defined as the occurrence of a fatal MI, death caused by documented cardiac arrest, death resulting from heart failure in a participant with known CHD, death from other forms of acute/chronic CHD, unwitnessed death of unknown origin, or sudden death.|From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)|All-Randomized ITT Population||Participants|||Count of Participants
804755|NCT01000727|Secondary|Number of Participants With First Occurrence of Stroke (Fatal/Non-fatal) During the Time Period for Follow-up of Cardiovascular Events|Stroke is defined as the presence of a new focal neurologic deficit thought to be of vascular origin, with signs/symptoms lasting >24 hours or results in death (in <24 hours).|From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)|All-Randomized ITT Population||Participants|||Count of Participants
804756|NCT01000727|Secondary|Number of Participants With First Occurrence of MI (Fatal/Nonfatal) During the Time Period for Follow-up of Cardiovascular Events|Acute MI is defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI.|From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)|All-Randomized ITT Population||Participants|||Count of Participants
804757|NCT01000727|Secondary|Number of Participants With Cardiovascular Death During the Time Period for Follow-up of Cardiovascular Events|CV death is defined as a death due to a CV cause, which includes but is not limited to deaths resulting from stroke, arrhythmia, sudden death (witnessed/unwitnessed), MI, heart failure, pulmonary embolism, peripheral arterial disease, or complications of a CV procedure. Deaths not clearly attributable to non-CV causes are considered to be CV deaths.|From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)|All-Randomized ITT Population||Participants|||Count of Participants
804758|NCT01000727|Secondary|Number of Participants With First Occurrence of Any Component of the Composite of Major Adverse Cardiovascular Events (Cardiovascular [CV] Death, Non-fatal MI or Non-fatal Stroke) During the Time Period for Follow-up of CV Events|CV death=death due to a CV cause, which included but was not limited to deaths resulting from stroke, arrhythmia, sudden death (witnessed/unwitnessed), MI, heart failure, pulmonary embolism, peripheral arterial disease, or complications of a CV procedure. Deaths not clearly attributable to non-CV causes are considered to be CV deaths. Acute MI=evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI. Stroke=presence of a new focal neurologic deficit thought to be of vascular origin, with signs/symptoms lasting >24 hours or results in death (in <24 hours).|From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)|All-Randomized ITT Population||Participants|||Count of Participants
804782|NCT01000974|Secondary|Number of Subjects With AEs of Specific Interest (AESIs)|An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.|From booster dose until 6 months following receipt of the booster dose|Analysis was performed on the Booster Total Vaccinated cohort which included all subjects from Primary Total Vaccinated cohort that received the booster vaccine dose.||Subjects|||Number
804759|NCT01000727|Primary|Number of Participants With First Occurrence of Any Event in the Composite of Major Coronary Events During the Time Period for Follow-up (FU) of Cardiovascular (CV) Event|Coronary heart disease (CHD) death=occurrence of a fatal myocardial infarction (MI), death caused by documented cardiac arrest, death resulting from heart failure in a participant with known CHD, death from other forms of acute/chronic CHD, unwitnessed death of unknown origin, or sudden death. Acute MI=evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a nonischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI. Urgent coronary revascularization (CR) for MI=ischemic discomfort at rest that prompted CR during the same hospitalization or resulted in hospital transfer for the purpose of CR.|From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)|All-Randomized intent-to-treat (ITT) Population consisted of all randomized participants.||Participants|||Count of Participants
804760|NCT01000805|Secondary|Change From Baseline in Weight up to Week 8|"The change from baseline in weight at week 8 is the primary analysis. For the primary analysis of weight, the Least Squares (LS) Mean Value was adjusted for treatment, investigator, baseline, treatment*visit interaction, and baseline*visit interaction.
The change from baseline in weight up to week 8 is the secondary analysis. The LS Mean Value was adjusted for treatment, investigator, and baseline."|Baseline, up to week 8|"Primary analysis: All randomized participants with a baseline and at least 1 post-baseline result.
Secondary analysis: All randomized participants with a baseline and at least 1 nonmissing post-baseline result, Last Observation Carried Forward (LOCF)."||kilograms (kg)||Standard Error|Least Squares Mean
804761|NCT01000805|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Up to Week 8|"The change from baseline in SBP and DBP at week 8 is the primary analysis. For the primary analysis of SBP and DBP, the Least Squares (LS) Mean Value was adjusted for treatment, investigator, baseline, treatment*visit interaction, and baseline*visit interaction.
The change from baseline in SBP and DBP up to week 8 is the secondary analysis. The LS Mean Value was adjusted for treatment, investigator, and baseline."|Baseline, up to week 8|"Primary analysis: All randomized participants with a baseline and at least 1 post-baseline result.
Secondary analysis: Intention-to-treat population (ITT) with nonmissing baseline value and at least 1 nonmissing post-baseline value, Last Observation Carried Forward (LOCF)."||mm Hg||Standard Error|Least Squares Mean
804762|NCT01000805|Secondary|Change From Baseline in Pulse Rate up to Week 8|"The change from baseline in pulse rate at week 8 is the primary analysis. For the primary analysis of pulse rate, the Least Squares (LS) Mean Value was adjusted for treatment, investigator, baseline, treatment*visit interaction, and baseline*visit interaction.
The change from baseline in pulse rate up to week 8 is the secondary analysis. The LS Mean Value was adjusted for treatment, investigator, and baseline."|Baseline, up to week 8|"Primary analysis: All randomized participants with a baseline and at least 1 post-baseline result.
Secondary analysis: Intention-to-treat population (ITT) with nonmissing baseline value and at least 1 nonmissing post-baseline value, LOCF."||beats per minute (bpm)||Standard Error|Least Squares Mean
804763|NCT01000805|Other Pre-specified|Number of Participants With Abnormal Laboratory Values During the Double-blind Treatment Phase – High Alanine Amino Transferase/Serum Glutamate Pyruvate Transaminase (ALT/SGPT)|Laboratory assessment of ALT/SGPT during the double-blind treatment phase. Normal ALT/SGPT ranges for males are 6.00 units per liter (U/L) (low) to 43.00 U/L (high). Normal ALT/SGPT ranges for females are 6.00 U/L (low) to 34.00 U/L (high).|Baseline through 8 weeks|All randomized participants with a normal baseline (respective to the specified direction) and at least 1 post-baseline result.||participants|||Number
804764|NCT01000805|Secondary|Number of Participants With Suicidal Behaviors, Ideations, and Acts Based on the Columbia Suicide Severity Rating Scale (C-SSRS) During the Double-blind Treatment Phase|"The C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors, ideations, and acts are provided. Suicidal behavior: a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, and completed suicide. Suicidal ideation: a yes answer to any 1 of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation. Suicidal acts: a yes answer to actual attempt or completed suicide."|Baseline through 8 weeks|All randomized participants with at least 1 post-baseline C-SSRS result.||participants|||Number
804765|NCT01000805|Secondary|Patient's Global Impressions of Improvement Scale (PGI-I) at Week 8|A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, and treatment*visit interaction.|8 weeks|All randomized participants with a baseline and at least 1 post-baseline result.||units on a scale||Standard Error|Least Squares Mean
804766|NCT01000805|Secondary|Change From Baseline in the Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 8|Measures pain severity and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference=average of nonmissing scores of individual interference items. LS Mean Value adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.|Baseline, 8 weeks|All randomized participants with a baseline and at least 1 post-baseline result.||units on a scale||Standard Error|Least Squares Mean
804767|NCT01000805|Secondary|Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score at Week 2|The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range from 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.|Baseline, 2 weeks|All randomized participants with a baseline and at least 1 post-baseline result.||units on a scale||Standard Error|Least Squares Mean
804816|NCT01001078|Secondary|Airway Manipulation and Blood on Device at Removal||During and after anesthesia when the device is removed.|||participants|||Number
804768|NCT01000805|Secondary|Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score at Week 4|The MADRS is a rating scale for severity of depressive mood and symptoms. The MADRS has a 10-item checklist. Items are rated on a scale from 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.|Baseline, 4 weeks|All randomized participants with a baseline and at least 1 post-baseline result.||units on a scale||Standard Error|Least Squares Mean
804769|NCT01000805|Secondary|Percentage of Participants Achieving Remission up to Week 8|The Montgomery Asberg Depression Rating Scale (MADRS) is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale from 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Remission is defined as achieving a MADRS total score ≤12 at the last 2 nonmissing consecutive visits (for example, visit 3 [week 1] and visit 4 [week 2], or visit 4 [week 2] and visit 5 [week 4], or visit 5 [week 4] and visit 6 [week 8]).|Up to 8 weeks|All randomized participants with a baseline and at least 1 post-baseline value.||percentage of participants|||Number
804770|NCT01000805|Secondary|Change From Baseline in the Percentage of Participants Achieving Remission up to Week 8|The Montgomery Asberg Depression Rating Scale (MADRS) is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Remission is defined as achieving a MADRS total score ≤12.|Baseline, up to 8 weeks|All randomized participants with a post-baseline result, Last Observation Carried Forward (LOCF).||percentage of participants|||Number
804771|NCT01000805|Secondary|Change From Baseline in the Sheehan Disability Scale (SDS) Total and Item Scores at Week 8|SDS is completed by participant; used to assess effect of the participant's symptoms on their work/social/family life. Total scores range from 0 to 30; higher values indicate greater disruption in the participant's work/social/family life. Each item score ranges from 0 to 10 with higher values indicating greater disruption in the participant's work/school life (item 1), social life/leisure activities (item 2), or family life/home responsibilities (item 3). The LS Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.|Baseline, 8 weeks|All randomized participants with a baseline and at least 1 post-baseline result.||units on a scale||Standard Error|Least Squares Mean
804772|NCT01000805|Primary|Change From Baseline in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score at Week 8|The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.|Baseline, 8 weeks|All randomized participants with a baseline and at least 1 post-baseline result.||units on a scale||Standard Error|Least Squares Mean
804773|NCT01000805|Primary|Change From Baseline in the Brief Pain Inventory-Short Form (BPI-SF) Average Pain Score During the 8-week Treatment Period|A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). The overall change is based on the estimated main treatment effect. The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.|Day 1 through 8 weeks|All randomized participants with a baseline and at least 1 post-baseline result.||units on a scale||Standard Error|Least Squares Mean
804774|NCT01000818|Primary|Plasma Area Under Curve (AUC 0-12 hr ) for Raltegravir|Area Under the Plasma Concentration-Time Curve and peak concentration|12 hours postdose|Eighteen HIV-Infected Patients||µM*hr||95% Confidence Interval|Geometric Mean
804775|NCT01000961|Secondary|Comparison of Cysteamine PK Profiles, AUC(0-t), Between RP103 and Cystagon®.||6 hours post dosing for Cystagon®; 12 hours post dosing for RP103.|||AUC(0-t) (min*mg/L)||Standard Deviation|Least Squares Mean
804776|NCT01000961|Secondary|Comparison of Cysteamine PK Profiles, Steady State Tmax, Between RP103 and Cystagon®.||4 weeks after the last subject has completed the study|||Tmax (minute)||Standard Deviation|Least Squares Mean
804777|NCT01000961|Secondary|Comparison of Cysteamine PK Profiles, Steady State Cmax, Between RP103 and Cystagon®.||4 weeks after the last subject has completed the study|||Cmax (mg/L)||Standard Deviation|Least Squares Mean
804778|NCT01000961|Primary|The Steady-state White Blood Cell Cystine Levels of RP103 Compared to Cystagon®||4 weeks after the last subject has completed the study|||nmol ½ Cystine / mg protein||Standard Error|Least Squares Mean
804779|NCT01000974|Secondary|Anti-FHA, Anti-PRN and Anti-PT Antibody Concentrations|Antibody concentrations were given as geometric mean concentrations (GMCs) expressed as enzyme-linked immuno-sorbent assay (ELISA) units per milliliter i.e. EL.U/mL.|pre-booster and one month after booster vaccination|The analysis was performed on the Booster According-to-Protocol (ATP) cohort for immunogenicity that included all evaluable subjects for whom assay results were available for antibodies against at least 1 antigen for the blood sample taken 1 month after the administration of the booster vaccine dose||EL.U/mL||95% Confidence Interval|Geometric Mean
804780|NCT01000974|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From the booster dose until 6 months following receipt of the booster dose|Analysis was performed on the Booster Total Vaccinated cohort which included all subjects from Primary Total Vaccinated cohort that received the booster vaccine dose.||Subjects|||Number
804781|NCT01000974|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs).|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within 31 days (Day 0 to Day 30) following the booster dose|Analysis was performed on the Booster Total Vaccinated cohort which included all subjects from Primary Total Vaccinated cohort that received the booster vaccine dose.||Subjects|||Number
804783|NCT01000974|Secondary|Number of Subjects With Any Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, irritability, fever and loss of appetite. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination. Any fever= Axillary temperature equal to or above (≥) 38 degrees Celsius (°C).|Within 4 days (Days 0-3) following the booster dose|Analysis was performed on the Booster Total Vaccinated cohort which included all subjects from Primary Total Vaccinated cohort that received the booster vaccine dose and had the symptom sheets completed.||Subjects|||Number
804784|NCT01000974|Secondary|Number of Subjects With Any Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any symptom regardless of intensity grade.|Within 4 days (Days 0-3) following the booster dose|Analysis was performed on the Booster Total Vaccinated cohort which included all subjects from Primary Total Vaccinated cohort that received the booster vaccine dose and had the symptom sheets completed.||Subjects|||Number
804785|NCT01000974|Secondary|Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL and ≥1.0 IU/mL, Respectively.|Evaluation of persistence of anti-D, anti-T antibodies induced by Pediarix or Pentacel and Engerix-B prior to the administration of a booster dose of Hib vaccine at 15-18 months of age and evaluation of immunogenicity of a booster dose of Infanrix co-administered with Hiberix, a booster dose of Infanrix co-administered with ActHIB and a booster dose of Pentacel with respect to anti-D and anti-T antibodies.|Prior to the booster vaccination and 1 month after the booster vaccination|The analysis was performed on the Booster According-to-Protocol (ATP) cohort for immunogenicity that included all evaluable subjects for whom assay results were available for antibodies against at least 1 antigen for the blood sample taken 1 month after the administration of the booster vaccine dose.||Subjects|||Number
804786|NCT01000974|Secondary|Number of Subjects With Anti-Polio-1,2,3 Antibody Titers ≥ 8|Anti-polio 1,2,3 antibody titers greater or equal to the cut off value were calculated.|Prior to booster vaccination|The analysis was performed on the Booster ATP cohort for immunogenicity which included subjects for whom assay results were available for antibodies against at least 1 antigen for the blood sample taken 1 month after the administration of the booster vaccine dose.||Subjects|||Number
804787|NCT01000974|Secondary|Anti-poliovirus Types 1, 2, and 3 Antibody Titres and Titres ≥ 8|Antibody concentrations were tabulated as geometric mean titers (GMTs) and expressed as titers.|Prior to the booster vaccination|The analysis was performed on the Booster ATP cohort for immunogenicity which included subjects for whom assay results were available for antibodies against at least 1 antigen for the blood sample taken 1 month after the administration of the booster vaccine dose.||Titers||95% Confidence Interval|Geometric Mean
804788|NCT01000974|Secondary|Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ 5 EL.U/mL|Evaluation of persistence of anti-PT, anti-FHA and anti-PRN antibodies induced by Pediarix or Pentacel and Engerix-B prior to the administration of a booster dose of Hib vaccine at 15-18 months of age and evaluation of immunogenicity of a booster dose of Infanrix co-administered with Hiberix, a booster dose of Infanrix co-administered with ActHIB and a booster dose of Pentacel with respect to anti-PT, anti-FHA and anti- PRN antibodies.|Prior to the booster vaccination and 1 month after the booster vaccination|The analysis was performed on the Booster According-to-Protocol (ATP) cohort for immunogenicity that included all evaluable subjects for whom assay results were available for antibodies against at least 1 antigen for the blood sample taken 1 month after the administration of the booster vaccine dose.||Subjects|||Number
804789|NCT01000974|Secondary|Number of Subjects With Anti-HB Antibody Concentrations ≥10.0 mlU/mL and ≥6.2mLU/mL|The cut-off values were defined as a concentration≥ 6.2 mIU/mL (seropositivity) and ≥ 10 mIU/mL (seroprotection).|Prior to booster vaccination|The analysis was performed on the Booster According-to-Protocol (ATP) cohort for immunogenicity that included all evaluable subjects for whom assay results were available for antibodies against at least 1 antigen for the blood sample taken 1 month after the administration of the booster vaccine dose||Subjects|||Number
804790|NCT01000974|Secondary|Anti-Hepatitis B (Anti-HBs) Antibody Concentrations ≥10.0 mIU/mL and ≥6.2 mIU/mL|Antibody concentrations were expressed as geometric mean concentrations (GMCs) and expressed as milli-international units per milliliter (mIU/mL).|Prior to the booster vaccination|The analysis was performed on the Booster According-to-Protocol (ATP) cohort for immunogenicity that included all evaluable subjects for whom assay results were available for antibodies against at least 1 antigen for the blood sample taken 1 month after the administration of the booster vaccine dose.||mIU/mL||95% Confidence Interval|Geometric Mean
804791|NCT01000974|Secondary|Anti-polyribosylribitol Phosphate (PRP) Antibody Concentrations|Antibody concentrations were given as Geometric Mean Concentrations (GMCs) expressed in micrograms per milliliter (µg/mL).|Prior to the booster vaccination and 1 month after the booster vaccination|The analysis was performed on the Booster According-to-Protocol (ATP) cohort for immunogenicity that included all evaluable subjects for whom assay results were available for antibodies against at least 1 antigen for the blood sample taken 1 month after the administration of the booster vaccine dose.||µg/mL||95% Confidence Interval|Geometric Mean
804792|NCT01000974|Secondary|Number of Subjects With Anti-HBs Antibody Concentrations Greater Than or Equal to Cut-off Values|The cut-off values were defined as a concentration≥ 3.3 mIU/mL (seropositivity) and ≥ 10 mIU/mL (seroprotection).|At 1 month after last dose of primary vaccination|The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.||Subjects|||Number
804793|NCT01000974|Secondary|Antibody Titers for Poliovirus Types 1, 2 and 3|Antibody titers were given as geometric mean titers(GMTs).|At 1 month after last dose of primary vaccination|The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.||Titers||95% Confidence Interval|Geometric Mean
804870|NCT01001195|Primary|Change From Baseline in Average Eye Intraocular Pressure (IOP)|IOP is a measurement of the fluid pressure inside the eye. The average of the 2 eyes is used for the analyses. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening).|Baseline, Day 29 Hour 0|Modified Intent to Treat: all randomized and treated patients who had at least a baseline visit and 1 postbaseline IOP evaluation||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
804794|NCT01000974|Secondary|Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL|Evaluation of immunogenicity of a 3-dose primary vaccination course of Prevnar 13 co-administered with Hiberix, Rotarix and Pediarix, of Prevnar 13 co-administered with ActHIB, Rotarix and Pediarix and of Prevnar 13 co-administered with Pentacel, Rotarix and Engerix-B in terms of S.pneumoniae GMCs and antibody concentrations ≥ 0.05µg/mL, ≥ 0.2 µg/mL, ≥ 1.0 µg/mL at one month after the last dose of primary vaccination.|At 1 month after the last dose of primary vaccination|The analysis was based on the Primary According-to-Protocol (ATP)cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.||Subjects|||Number
804795|NCT01000974|Secondary|Anti-Hepatitis B (Anti-HBs) Antibody Concentrations|Antibody concentrations were tabulated as geometric mean concentrations (GMCs) and expressedas milli-international units per milliliter (mIU/mL).|At 1 month after last dose of primary vaccination|The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.||mIU/mL||95% Confidence Interval|Geometric Mean
804796|NCT01000974|Secondary|Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations ≥ 0.15 µg/mL and ≥ 1.0 µg/mL|Evaluation of persistence of anti-PRP antibodies induced by three primary vaccine doses of Hiberix, and ActHIB, each co-administered with Pediarix, Prevnar 13 and Rotarix, or Pentacel co-administered with Engerix-B, Rotarix and Prevnar 13 prior to the booster dose of Hiberix, ActHIB or Pentacel at 15-18 months of age and evaluation of immunogenicity of a booster dose of Hiberix co-administered with Infanrix, ActHIB co-administered with Infanrix and Pentacel in terms of the percentage of subjects with anti-PRP concentrations ≥0.15 µg/mL, ≥1.0 µg/mL and GMCs one month after the booster dose.|Prior to the booster vaccination and 1 month after the booster vaccination|The analysis was performed on the Booster According-to-Protocol (ATP) cohort for immunogenicity that included all evaluable subjects for whom assay results were available for antibodies against at least 1 antigen for the blood sample taken 1 month after the administration of the booster vaccine dose||Subjects|||Number
804797|NCT01000974|Secondary|Number of Subjects With Anti-PT, Anti-PRN and Anti-FHA Antibody Concentrations ≥ 5 EL.U/mL|Seroresponse was defined as the number of subjects showing a concentration above a threshold that leads to 90% seroresponse in the ActHIB group.|At 1 month after last dose of primary vaccination|The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.||Subjects|||Number
804798|NCT01000974|Secondary|Number of Subjects With Seroresponse (90%) to Anti-PT, Anti-PRN and Anti-FHA|Seroresponse (90%) was defined as the number of subjects showing a concentration above a threshold that leads to 90% seroresponse in the ActHIB group.|At 1 month after last dose of primary vaccination|The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.||Subjects|||Number
804799|NCT01000974|Secondary|Number of Subjects With AEs of Specific Interest (AESIs)|An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.|From Day 0 until 6 months following the last primary dose or the receipt of the booster vaccination, whichever comes first|The analysis was based on the Primary Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine dose documented.||Subjects|||Number
804800|NCT01000974|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Day 0 until 6 months following the last primary dose|The analysis was based on the Primary Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine dose documented.||Subjects|||Number
804801|NCT01000974|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs).|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Day 0-Day 30) follow-up period after primary vaccination|The analysis was based on the Primary Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine dose documented.||Subjects|||Number
804802|NCT01000974|Secondary|Number of Subjects With Any Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, irritability, fever and loss of appetite. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination. Any fever= Rectal temperature equal to or above (≥) 38 degrees Celsius (°C).|During a 4-day follow-up period (Days 0-3) following any vaccination|The analysis was based on the Primary Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine dose documented and symptom sheets completed.||Subjects|||Number
804803|NCT01000974|Secondary|Number of Subjects With Any Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any symptom regardless of intensity grade.|During a 4-day follow-up period (Days 0-3) following any vaccination|The analysis was based on the Primary Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine dose documented and with symptom sheets completed.||Subjects|||Number
804804|NCT01000974|Secondary|Anti-protein-D (Anti-D) and Anti-protein-T (Anti-T) Antibody Concentrations|Antibody concentrations were given as geometric mean concentrations (GMCs) and expressed as International Units per milliliter (IU/mL).|At 1 month after last dose of primary vaccination|The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.||IU/mL||95% Confidence Interval|Geometric Mean
804805|NCT01000974|Primary|Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations ≥ 1.0 µg/mL|Non-inferiority of a booster dose of Hiberix co-administered with Infanrix in subjects 15-18 months of age who received 3 primary vaccine doses of Hiberix to a booster dose of ActHIB co-administered with Infanrix in subjects of 15-18 months of age who received 3 primary vaccine doses of ActHIB in terms of immune response to PRP|At 1 month after booster vaccination|The analysis was performed on the Booster According-to-Protocol (ATP) cohort for immunogenicity that included all evaluable subjects for whom assay results were available for antibodies against at least 1 antigen for the blood sample taken 1 month after the administration of the booster vaccine dose||Subjects|||Number
804806|NCT01000974|Primary|Number of Subjects With Anti-Polio 1,2,3 Antibody Titres Greater Than or Equal to Cut-off Value|"The cut-off value was defined as a concentration ≥ 8 ED50 (ED50 is the concentration at which the protein exhibits 50% of its maximum activity).
The polio testing which started at the Biomnis laboratory was stopped because the polio virus micro-neutralization assays were found to be not in line with the quality standards defined in GSK Biologicals’ SOPs. As a result, polio testing was restarted at the GSK laboratory and the results were uploaded into the clinical database."|At 1 month after last dose of primary vaccination|The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.||Subjects|||Number
804807|NCT01000974|Primary|Number of Subjects With Seroresponse (95%) to Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA)|Seroresponse (95%) was defined as the number of subjects showing a concentration above a threshold that leads to 95% seroresponse in the ActHIB group.|At 1 month after last dose of primary vaccination|The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.||Subjects|||Number
804808|NCT01000974|Primary|Anti-Streptococcus Pneumoniae (S.Pneumoniae) Antibody Concentrations|Antibody concentrations against S.pneumoniae were given as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL).|At 1 month after last dose of primary vaccination|The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.||µg/mL||95% Confidence Interval|Geometric Mean
804809|NCT01000974|Primary|Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibody Concentrations|Antibody concentrations were given as geometric mean concentrations (GMCs) expressed as enzyme-linked immuno-sorbent assay (ELISA) units per milliliter i.e. EL.U/mL.|At 1 month after last dose of primary vaccination|The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.||EL.U/mL||95% Confidence Interval|Geometric Mean
804810|NCT01000974|Primary|Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations|Antibody concentrations were given as Geometric Mean Concentrations (GMCs) expressed in micrograms per milliliter (µg/mL).|At 1 month after last dose of primary vaccination|The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.||µg/mL||95% Confidence Interval|Geometric Mean
804811|NCT01000974|Primary|Number of Subjects With Anti-Protein-D (Anti-D) and Anti-Protein-T (Anti-T) Antibody Concentrations ≥ 0.1 International Units Per Milliliter (IU/mL)|Non-inferiority of Pediarix co-administered with Hiberix, Prevnar13 and Rotarix compared to Pediarix co-administered with ActHIB, Prevnar13 and Rotarix following 3 primary vaccine doses in terms of immune response to Diphtheria, Tetanus.|At 1 month after last dose of primary vaccination|The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.||Subjects|||Number
804812|NCT01000974|Primary|Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to (≥) 0.15 Microgram Per Milliliter (µg/mL) and ≥ 1.0 µg/mL|Non-inferiority of Hiberix to ActHIB, each co-administered with Pediarix, Prevnar13 and Rotarix following 3 primary doses in terms of immune response to PRP (Anti-PRP≥ 0.15 µ g/ml and ≥1.0 µg/mL).|At 1 month after last dose of primary vaccination|The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and assay results available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.||Subjects|||Number
804813|NCT01001052|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] for Colcrys™|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 18, 24, 36, 48, 60 and 72 hours post-dose|||ng*hr/mL||Standard Deviation|Mean
804814|NCT01001052|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)] for Colcrys™|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 18, 24, 36, 48, 60 and 72 hours post-dose|||ng*hr/mL||Standard Deviation|Mean
804815|NCT01001052|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that Colcrys™ (colchicine) reaches in the plasma.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 18, 24, 36, 48, 60 and 72 hours post-dose|||ng/mL||Standard Deviation|Mean
804817|NCT01001078|Secondary|Adverse Effects After Anesthesia (Sore Throat, Cough, Dysphagia, Dysphonia)|Intent to treat assessment of adverse events, per intervention, was intended. The adverse effects were assessed by phone; or in person if patient in the hospital; on the following day.|On the day following surgery|"5 participants were lost to follow-up and 4 participants had the crossover device or were intubated in the I-Gel group.
4 participants were lost to follow-up and 3 participants had the crossover device or were intubated in the LMA Supreme group (one of participants was lost to follow-up and had the crossover device or was intubated)"||participants|||Number
804818|NCT01001078|Secondary|Number of Participants With Successful Attempts to Introduce the Devices||At the beginning of anesthesia before the beginning of the surgery.|||participants|||Number
804819|NCT01001078|Secondary|Time Needed to Secure the Airway||From opening of the mouth to thoracic expansion and presence of End Tidal CO2 up to five minutes.|||seconds||Standard Deviation|Mean
804820|NCT01001078|Secondary|Measure of the Peak Airway Pressure||After introduction of the SAD before the beginning of the surgery.|||cm H20||Standard Deviation|Mean
804821|NCT01001078|Primary|Measure of the Airway Leak Pressure||After introduction of the supraglottic device before the beginning of the surgery.|||cmH2O||Standard Deviation|Mean
804822|NCT01001104|Secondary|Percentage of Participants With Self-Reported Hypoglycemic Episodes During the 12-week Treatment Period|Assessed the percentage of participants who reported a hypoglycemic episode during the 12-week treatment period. Hypoglycemia was defined as a measured plasma glucose level of ≤70 milligrams per deciliter (mg/dL) or ≤3.9 millimoles per liter (mmol/L).|12 weeks|Full analysis set: All randomized participants who received at least 1 dose of the study drug.||percentage of participants|||Number
804823|NCT01001104|Secondary|Steady-State Concentrations of LY2189265|Evaluable pharmacokinetics (PK) concentrations from all sampling time-points were combined and utilized in a population approach to determine the population mean estimate and standard deviation at 12 weeks. The model predicted LY2189265 steady state concentrations in each dose level were calculated as estimated area under the curve (AUC)/dosing period of 168 hours. The models and model parameters were described by nonlinear, mixed-effects regression modeling (NONMEM) using the program NONMEM 7®.|12 weeks|Full analysis set: All randomized participants who received at least 1 dose of the study drug.||nanograms per milliliter (ng/mL)||90% Confidence Interval|Median
804824|NCT01001104|Secondary|Change From Baseline in Beta-Cell Function Using the Updated Homeostasis Model Assessment Beta-Cell Function (HOMA2-B) at 12 Weeks|HOMA2-B is an estimated steady state beta cell function based on updated HOMA2 model. The HOMA2 model estimates steady state pancreatic beta cell function (%B) as a percentage of a normal reference population using simultaneously measured fasting plasma glucose and fasting insulin. Changes in HOMA2-B were analyzed by a mixed model repeated measures (MMRM) model that included dose, pre-study therapy, body mass index (BMI) group at baseline, baseline value, visit, and dose*visit, where the participant was treated as a random effect.|Baseline, 12 weeks|Full analysis set: All randomized participants who received at least 1 dose of the study drug.||percentage beta-cell function||95% Confidence Interval|Least Squares Mean
804825|NCT01001104|Secondary|Change From Baseline in Insulin Sensitivity Using the Updated Homeostasis Model Assessment Insulin Sensitivity (HOMA2-S) at 12 Weeks|HOMA2-S is an estimated insulin sensitivity based on updated HOMA2 model. The HOMA2 model is a computer model that estimates insulin sensitivity (%S) as percentages of a normal reference population using simultaneously measured fasting plasma glucose and fasting insulin. Changes in HOMA2-S were analyzed by a mixed model repeated measures (MMRM) model that included dose, pre-study therapy, body mass index (BMI) group at baseline, baseline value, visit, and dose*visit, where the participant was treated as a random effect.|Baseline, 12 weeks|Full analysis set: All randomized participants who received at least 1 dose of the study drug.||percentage insulin sensitivity (%S)||95% Confidence Interval|Least Squares Mean
804826|NCT01001104|Secondary|Change From Baseline in Total Body Weight at 12 Weeks|Changes in body weight were analyzed by a mixed model repeated measures (MMRM) model that included dose, pre-study therapy, body mass index (BMI) group at baseline, baseline value, visit, and dose*visit, where the participant was treated as a random effect.|Baseline, 12 weeks|Full analysis set: All randomized participants who received at least 1 dose of the study drug.||kilograms (kg)||95% Confidence Interval|Least Squares Mean
804827|NCT01001104|Secondary|Change From Baseline in the Mean Daily Blood Glucose (Based on Self-Monitoring Blood Glucose [SMBG]) at 12 Weeks|SMBG levels were measured at the following 7 timepoints during the day: fasting prebreakfast, 2 hours postbreakfast, prior to lunch, 2 hours postlunch, prior to dinner, 2 hours postdinner, and prior to bed. The change in mean daily blood glucose was analyzed by a mixed model repeated measures (MMRM) model that included dose, pre-study therapy, body mass index (BMI) group at baseline, baseline value, and dose*visit, where the participant was treated as a random effect.|Baseline, 12 weeks|Full analysis set: All randomized participants who received at least 1 dose of the study drug.||milligrams per deciliter (mg/dL)||95% Confidence Interval|Least Squares Mean
804828|NCT01001104|Secondary|Change From Baseline in Fasting Blood Glucose (FBG) Values to 12 Weeks|Change in FBG following 12 weeks of therapy (that is, FBG at week 12 minus FBG at baseline). The change in FBG was analyzed using a mixed model repeated measures (MMRM) model that included dose, pre-study therapy, body mass index (BMI) group at baseline, baseline value, visit, and dose*visit, where the participant was treated as a random effect.|Baseline, 12 weeks|Full analysis set: All randomized participants who received at least 1 dose of the study drug.||milligrams per deciliter (mg/dL)||95% Confidence Interval|Least Squares Mean
804829|NCT01001104|Secondary|Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c)<6.5% up to 12 Weeks|Percentage of participants achieving HbA1c<6.5% up to the 12-week endpoint.|up to 12 weeks|All randomized participants who received at least 1 dose of the study drug, last observation carried forward (LOCF).||percentage of participants|||Number
804830|NCT01001104|Secondary|Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c)<7% up to 12 Weeks|Percentage of participants who achieved HbA1c<7% up to the 12-week endpoint.|up to 12 weeks|All randomized participants who received at least 1 dose of the study drug, last observation carried forward (LOCF).||percentage of participants|||Number
804899|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 8: Area Under the Time Concentration Curve From Time 0 To the Real Time Tlast (AUClast)||7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined||ng*hr/ml||Standard Deviation|Mean
804831|NCT01001104|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 12 Weeks|Change in HbA1c from baseline following 12 weeks of therapy (that is, HbA1c at week 12 minus HbA1c at baseline). Changes in HbA1c were analyzed by a mixed model repeated measures (MMRM) model that included dose, pre-study therapy, body mass index (BMI) group at baseline, baseline value, visit, and dose*visit, where the participant was treated as a random effect.|Baseline, 12 weeks|Full analysis set: All randomized participants who received at least 1 dose of the study drug.||percentage glycosylated hemoglobin||95% Confidence Interval|Least Squares Mean
804832|NCT01001169|Secondary|Number of Subjects With Normal or Abnormal Values of Haematological Parameters|"Among haematological parameters assessed were Basophils (Baso), Eosinophils (EOS), Hematocrit (HEM), Hemoglobin (Hgb), Lymphocytes (LYM), Monocytes (MON), Neutrophils (NEU), Platelets (PLA), Red Blood Cells (RBC) and White Blood Cells (WBC).
Unknown = value unknown for the specified time point and laboratory parameter; Below = value below the laboratory reference range defined for the specified time point and laboratory parameter; Within = value within the laboratory reference range defined for the specified time point and laboratory parameter; Above = value above the laboratory reference range defined for the specified time point and laboratory parameter."|At Days 0, 7 and 42|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.||Subjects|||Number
804833|NCT01001169|Secondary|Number of Subjects With Normal or Abnormal Biochemical Levels|"Among biochemical parameters assessed were Alanine Amino Transferase (ALAT), Albumin, Alkaline Phosphatase (AP), Aspartate Amino Transferase (ASAT), Bilirubin, Bilirubin Conjugated/Direct, Cholesterol, Chloride, Creatinine, Creatine Phosphokinase (CK), Gamma-Glutamyl Transpeptidase (GGT), Potassium, Lactate dehydrogenase (LDH), Sodium, Protein, Urate/Uric acid and Blood Urea Nitrogen (BUN).
Unknown = value unknown for the specified time point and laboratory parameter; Below = value below the laboratory reference range defined for the specified time point and laboratory parameter; Within = value within the laboratory reference range defined for the specified time point and laboratory parameter; Above = value above the laboratory reference range defined for the specified time point and laboratory parameter."|At Days 0, 7 and 42|The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects.||Subjects|||Number
804834|NCT01001169|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Day 0 to Day 182)|The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects.||Subjects|||Number
804835|NCT01001169|Secondary|Number of Subjects With Potential Immune-Mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|During the entire study period (from Day 0 to Day 182)|The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects.||Subjects|||Number
804836|NCT01001169|Secondary|Number of Subjects With Medically Attended Events (MAEs)|MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. Analysis of intensity and relationship to vaccination of MAEs was not performed.|During the entire study period (from Day 0 to Day 182)|The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects.||Subjects|||Number
804837|NCT01001169|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|Up to 84 days (Days 0-83) after the first vaccination|The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects.||Subjects|||Number
804838|NCT01001169|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal, headache, joint pain at other location, muscle aches, shivering, sweating, and fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of any general symptoms regardless of their intensity grade or their relation to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0°C - ≤ 40.0°C. Related symptom = symptom assessed by the investigator as causally related to the study vaccination.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects.||Subjects|||Number
804839|NCT01001169|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any general symptoms regardless of their intensity grade or their relation to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = fever ≥ 39.0 °C - ≤ 40.0°C. Related = symptom assessed by the investigator as causally related to the vaccination.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects.||Subjects|||Number
804840|NCT01001169|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain [child below (<) 6 years] = cried when limb was moved/spontaneously painful. Grade 3 pain [child equal to or above (≥) 6 years] = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on The Total Vaccinated Cohort which included all vaccinated subjects.||Subjects|||Number
810710|NCT01048606|Secondary|Metabolic Rate at Rest: During 30 Minutes With a Breathing Mask by Indirect Calorimetry (CCM/D, Medgraphics Corp, St-Paul, MN, USA) After a 12-hour Fast, in the Early Morning.||0, 6 and 12 months||||||
804841|NCT01001169|Secondary|Number of Subjects With Vaccine Response Rates (VRR) for Neutralising Antibodies Against Flu A/Neth/602/09 H1N1|VRR is defined as the number of vaccinees that have a 4-fold increase between pre- and post-vaccination titers. The Flu strain assessed was Flu A/Neth/602/09 H1N1, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.|At Day 182|The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against Flu A/Neth/602/09 H1N1 antigen for the blood samples taken on Day 182 were available.||Subjects|||Number
804842|NCT01001169|Secondary|Number of Subjects With Vaccine Response Rates (VRR) for Neutralising Antibodies Against Flu A/Neth/602/09 H1N1|VRR is defined as the number of vaccinees that have a 4-fold increase between pre- and post-vaccination titers. The Flu strain assessed was Flu A/Neth/602/09 H1N1, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.|At Day 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom assay results for antibodies against Flu A/Neth/602/09 H1N1 antigen for the blood samples taken on Day 42 (21 days after the second vaccination) were available.||Subjects|||Number
804843|NCT01001169|Secondary|Number of Subjects With Vaccine Response Rates (VRR) for Neutralizing Antibodies Against Flu A/Neth/602/09 H1N1|VRR is defined as the number of vaccinees that have a 4-fold increase between pre- and post-vaccination titers. The Flu strain assessed was Flu A/Neth/602/09 H1N1, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.|At Day 21|The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against Flu A/Neth/602/09 H1N1 antigen for the blood sample taken 21 days after the first vaccination were available.||Subjects|||Number
804844|NCT01001169|Secondary|Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:8. The Flu strain assessed was Flu A/Neth/602/09 H1N1, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.|At Days 0 and 182|The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against Flu A/Neth/602/09 H1N1 antigen for the blood samples taken on Day 182 were available.||Titers||95% Confidence Interval|Geometric Mean
804845|NCT01001169|Secondary|Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:8. The Flu strain assessed was Flu A/Neth/602/09 H1N1, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.|At Days 0 and 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom assay results for antibodies against Flu A/Neth/602/09 H1N1 antigen for the blood samples taken on Day 42 (21 days after the second vaccination) were available.||Titers||95% Confidence Interval|Geometric Mean
804846|NCT01001169|Secondary|Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:8. The Flu strain assessed was Flu A/Neth/602/09 H1N1, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.|At Days 0 and 21|The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against Flu A/Neth/602/09 H1N1 antigen for the blood sample taken 21 days after the first vaccination were available.||Titers||95% Confidence Interval|Geometric Mean
804847|NCT01001169|Secondary|Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value|The cut-off values for the humoral immune response in terms of vaccine neutralizing antibodies were equal to or above (≥) 1:8. The Flu strain assessed was Flu A/Neth/602/09 H1N1, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.|At Days 0 and 182|The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against Flu A/Neth/602/09 H1N1 antigen for the blood samples taken on Day 182 were available.||Subjects|||Number
804848|NCT01001169|Secondary|Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value|The cut-off values for the humoral immune response in terms of vaccine neutralizing antibodies were equal to or above (≥) 1:8. The Flu strain assessed was Flu A/Neth/602/09 H1N1, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.|At Days 0 and 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom assay results for antibodies against Flu A/Neth/602/09 H1N1 antigen for the blood samples taken on Day 42 (21 days after the second vaccination) were available.||Subjects|||Number
804849|NCT01001169|Secondary|Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value|The cut-off values for the humoral immune response in terms of vaccine neutralizing antibodies were equal to or above (≥) 1:8. The Flu strain assessed was Flu A/Neth/602/09 H1N1, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.|At Days 0 and 21|The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against Flu A/Neth/602/09 H1N1 antigen for the blood sample taken 21 days after the first vaccination were available.||Subjects|||Number
804850|NCT01001169|Secondary|SCF for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease|"SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP guidance.
The CHMP Criterion was fulfilled if the point estimate for SCF was > 2.5."|At Day 182|The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood samples taken on Day 182 were available.||Titers||95% Confidence Interval|Geometric Mean
804900|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 8: Time to Maximum Concentration (Tmax)||7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined||hours (hr)||Full Range|Median
810711|NCT01048606|Secondary|Plasma Isoflavones (Diadzein) - a Marker of Phytoestrogen Compliance - Will be Measured by the ELISA Method||0, 6 and 12 months||||||
804851|NCT01001169|Secondary|SCF for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease|"SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years, following the CHMP guidance.
The CHMP Criterion was fulfilled if the point estimate for SCF was > 2.5. Note: Analyses based on 95% CI for 10-17 year age category at Day 42 were not performed."|At Day 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood samples taken on Day 42 (21 days after the second vaccination) were available.||Titers||95% Confidence Interval|Geometric Mean
804852|NCT01001169|Secondary|Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease|"Seroconversion factor (SCF) was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP guidance.
The CHMP Criterion was fulfilled if the point estimate for SCF was > 2.5."|At Day 21|The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after the first vaccination were available.||Titers||95% Confidence Interval|Geometric Mean
804853|NCT01001169|Secondary|Number of Seroprotected Subjects for HI Antibodies|"A seroprotected subject was defined as a vaccinated subject with a serum HI titer equal to or above (≥) 1:40. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.
The CHMP Criterion was fulfilled if the post-vaccination point estimate for SPR was > 70%.
The CBER Criterion was fulfilled if the lower 97.5% confidence interval for SPR was > 70%."|At Days 0 and 182|The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood samples taken on Day 182 were available.||Subjects|||Number
804854|NCT01001169|Secondary|Number of Seroprotected Subjects for HI Antibodies|"A seroprotected subject was defined as a vaccinated subject with a serum HI titer equal to or above (≥) 1:40. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years, following the CHMP and the CBER guidance.
The CHMP Criterion was fulfilled if the post-vaccination point estimate for SPR was > 70%.
The CBER Criterion was fulfilled if the lower 97.5% confidence interval for SPR was > 70%.
Note: Analyses based on 95% CI for 10-17 year age category at Day 42 were not performed."|At Days 0 and 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood samples taken on Day 42 (21 days after the second vaccination) were available.||Subjects|||Number
804855|NCT01001169|Secondary|Number of Seroprotected Subjects for HI Antibodies|"A seroprotected subject was defined as a vaccinated subject with a serum hemagglutination inhibition (HI) titer equal to or above (≥) 1:40. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.
The CHMP Criterion was fulfilled if the post-vaccination point estimate for SPR was > 70%.
The CBER Criterion was fulfilled if the lower 97.5% confidence interval for SPR was > 70%."|At Days 0 and 21|The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after the first vaccination were available.||Subjects|||Number
804856|NCT01001169|Secondary|Number of Seroconverted Subjects for HI Antibodies|"Seroconversion (SCR) was defined as follows:
For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.
The CHMP Criterion was fulfilled if the point estimate for SCR was > 40%. The CBER Criterion was fulfilled if the lower 97.5% confidence interval for SCR was > 40%."|At Day 182|The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood samples taken on Day 182 were available.||Subjects|||Number
804857|NCT01001169|Secondary|Number of Seroconverted Subjects for HI Antibodies|"Seroconversion (SCR) was defined as follows:
For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years, following the CHMP and the CBER guidance.
The CHMP Criterion was fulfilled if the point estimate for SCR was > 40%. The CBER Criterion was fulfilled if the lower 97.5% confidence interval for SCR was > 40%.
Note: Analyses based on 95% CI for 10-17 year age category at Day 42 were not performed."|At Day 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood samples taken on Day 42 (21 days after the second vaccination) were available.||Subjects|||Number
804858|NCT01001169|Secondary|Number of Seroconverted Subjects for HI Antibodies|"Seroconversion (SCR) was defined as follows:
For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.
The CHMP Criterion was fulfilled if the point estimate for SCR was > 40%. The CBER Criterion was fulfilled if the lower 97.5% confidence interval for SCR was > 40%."|At Day 21|The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after the first vaccination were available.||Subjects|||Number
804859|NCT01001169|Secondary|Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.|At Days 0 and 182|The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood samples taken on Day 182 were available.||Titers||95% Confidence Interval|Geometric Mean
804860|NCT01001169|Secondary|Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease|"Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years, following the CHMP and the CBER guidance.
Note: Analyses based on 95% CI for 10-17 year age category at Day 42 were not performed."|At Days 0 and 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood samples taken on Day 42 (21 days after the second vaccination) were available.||Titers||95% Confidence Interval|Geometric Mean
804861|NCT01001169|Secondary|Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.|At Days 0 and 21|The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after the first vaccination were available.||Titers||95% Confidence Interval|Geometric Mean
804862|NCT01001169|Secondary|Number of Subjects With HI Antibody Concentrations Above the Cut-off Value|The cut-off values for the humoral immune response in terms of vaccine H1N1 HI antibodies were equal to or above (≥) 1:10. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.|At Days 0 and 182|The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood samples taken on Day 182 were available.||Subjects|||Number
804863|NCT01001169|Secondary|Number of Subjects With HI Antibody Concentrations Above the Cut-off Value|"The cut-off values for the humoral immune response in terms of vaccine H1N1 HI antibodies were equal to or above (≥) 1:10. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years, following the CHMP and the CBER guidance.
Note: Analyses based on 95% CI for 10-17 year age category at Day 42 were not performed."|At Days 0 and 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable for whom assay results for antibodies against A/California-like HA antigen for the blood samples taken on Day 42 (21 days after the second vaccination) were available.||Subjects|||Number
804864|NCT01001169|Secondary|Number of Subjects With HI Antibody Concentrations Above the Cut-off Value|The cut-off values for the humoral immune response in terms of vaccine H1N1 HI antibodies were equal to or above (≥) 1:10. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.|At Days 0 and 21|The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after the first vaccination were available.||Subjects|||Number
804865|NCT01001169|Primary|Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease|"GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP guidance.
The CHMP Criterion was fulfilled if the point estimate for GMFR was > 2.5."|At Day 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable for whom assay results for antibodies against A/California-like HA antigen for the blood samples taken on Day 42 (21 days after the second vaccination) were available.||Titers||97.5% Confidence Interval|Geometric Mean
804866|NCT01001169|Primary|Number of Seroprotected Subjects for HI Antibodies|"A seroprotected subject was defined as a vaccinated subject with a serum hemagglutination inhibition (HI) titer equal to or above (≥) 1:40. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.
The CBER Criterion was fulfilled if the lower 97.5% confidence interval for seroprotection (SPR) was > 70%.
The CHMP Criterion was fulfilled if the post-vaccination point estimate for SPR was > 70%."|At Day 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable for whom assay results for antibodies against A/California-like HA antigen for the blood samples taken on Day 42 (21 days after the second vaccination) were available.||Subjects|||Number
804867|NCT01001169|Primary|Number of Seroconverted Subjects for HI Antibodies|"Seroconversion (SCR) was defined as follows:
For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.
The CBER criterion was fulfilled if the lower 97.5% confidence interval for SCR was > 40%.
The CHMP criterion was fulfilled if the point estimate for SCR was > 40%."|At Day 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable for whom assay results for antibodies against A/California-like HA antigen for the blood samples taken on Day 42 (21 days after the second vaccination) were available.||Subjects|||Number
804868|NCT01001169|Primary|Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.|At Day 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable for whom assay results for antibodies against A/California-like HA antigen for the blood samples taken on Day 42 (21 days after the second vaccination) were available.||Titers||97.5% Confidence Interval|Geometric Mean
804869|NCT01001169|Primary|Number of Subjects With Haemagglutination Inhibition (HI) Antibody Concentrations Above the Cut-off Value|"The cut-off values for the humoral immune response in terms of vaccine H1N1 HI antibodies were equal to or above (≥) 1:10.
The Flu strain assessed was A/California/7/2009 (H1N1)v-like virus (Flu A/CAL/7/09), in subjects aged between 6 months to 9 years and 10 to 17 years, following the Committee for Medicinal Products for Human Use (CHMP) and the Center for Biologics Evaluation and Research (CBER) guidance."|At Day 42|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood samples taken on Day 42 (21 days after the second vaccination) were available.||Subjects|||Number
804871|NCT01001208|Secondary|Change Form Baseline in Percentage of Body Surface Area Involved With Psoriasis at Week 24|A measurement of psoriasis involvement, given as the physician’s assessment of the percentage of the participant’s total body surface area (BSA) involved with psoriasis. The BSA numerical score was completed by a blinded assessor. A decrease from Baseline indicates improvement. Change from Baseline was calculated as Baseline score - Week 24 score; a positive change from Baseline therefore indicates improvement.|Baseline and 24 Weeks|Intention-to-Treat with available data; last observation carried forward (LOCF) imputation was used.||Percentage of BSA||Standard Deviation|Mean
804872|NCT01001208|Secondary|Change From Baseline in the Percentage of Body Surface Area Involved With Psoriasis at Week 12|A measurement of psoriasis involvement, given as the physician’s assessment of the percentage of the participant’s total body surface area (BSA) involved with psoriasis. The BSA numerical score was completed by a blinded assessor. A decrease from Baseline indicates improvement. Change from Baseline was calculated as Baseline score - Week 12 score; a positive change from Baseline therefore indicates improvement.|Baseline and 12 Weeks|Intention-to-Treat with available data; last observation carried forward (LOCF) imputation was used.||Percentage of BSA||Standard Deviation|Mean
804873|NCT01001208|Secondary|PASI 90 Response at Week 24|Percentage of participants achieving at least a 90% decrese (improvement) from Baseline in the Psoriasis Area and Severity Index (PASI) at Week 24. PASI Score incorporates measures of erythema, desquamation, infiltration, and affected body surface area. Involvement and severity of psoriasis was scored by a blinded assessor using a scale of 0 to 72, where 0 = no psoriasis and 72 = severe disease.|Baseline and 24 Weeks|Intention-to-Treat with available data; last observation carried forward (LOCF) imputation was used.||Percentage of participants|||Number
804874|NCT01001208|Secondary|PASI 90 Response at Week 12|Percentage of participants achieving at least a 90% decrease (improvement) from Baseline in the Psoriasis Area and Severity Index (PASI) at Week 12. PASI Score incorporates measures of erythema, desquamation, infiltration, and affected body surface area. Involvement and severity of psoriasis was scored by a blinded assessor using a scale of 0 to 72, where 0 = no psoriasis and 72 = severe disease.|Baseline and 12 Weeks|Intention-to-Treat with available data; last observation carried forward (LOCF) imputation was used.||Percentage of participants|||Number
804875|NCT01001208|Secondary|Static Physician Global Assessment (sPGA) Response at Week 12|Percentage of participants achieving a clear (0) or almost clear (1) status on the Static Physician Global Assessment (sPGA) at Week 12. This index evaluates the physician’s global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The assessment was scored by a blinded assessor on a scale of 0 to 5, where 0 = clear, with no evidence of plaque elevation, erythema, or scale, and 5 = severe induration, erythema, and scaling.|Week 12|Intention-to-Treat with available data; last observation carried forward (LOCF) imputation was used.||Percentage of participants|||Number
804876|NCT01001208|Secondary|PASI 75 Response at Week 12|Percentage of participants achieving at least a 75% decrease (i.e. improvement) from Baseline in the Psoriasis Area and Severity Index (PASI) at Week 12. PASI Score incorporates measures of erythema, desquamation, infiltration, and affected body surface area. Involvement and severity of psoriasis was scored by a blinded assessor using a scale of 0 to 72, where 0 = no psoriasis and 72 = severe disease.|Baseline and 12 Weeks|Intention-to-Treat with available data; last observation carried forward (LOCF) imputation was used||Percentage of participants|||Number
804877|NCT01001208|Secondary|PASI 50 Response at Week 12|Percentage of participants achieving at least a 50% decrease (improvement) from Baseline in the Psoriasis Area and Severity Index (PASI) at Week 12. PASI Score incorporates measures of erythema, desquamation, infiltration, and affected body surface area. Involvement and severity of psoriasis was scored by a blinded assessor using a scale of 0 to 72, where 0 = no psoriasis and 72 = severe disease.|Baseline and 12 Weeks|Intention-to-Treat with available data; last observation carried forward (LOCF) imputation was used.||Percentage of participants|||Number
804878|NCT01001208|Secondary|Static Physician Global Assessment (sPGA) Response at Week 24|Percentage of participants achieving a clear (0) or almost clear (1) status on the Static Physician Global Assessment (sPGA) at Week 24. This index evaluates the physician’s global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The assessment was scored by a blinded assessor on a scale of 0 to 5, where 0 = clear, with no evidence of plaque elevation, erythema, or scale, and 5 = severe induration, erythema, and scaling.|Week 24|Intention-to-Treat with available data; last observation carried forward (LOCF) imputation was used.||Percentage of participants|||Number
804879|NCT01001208|Secondary|PASI 50 Response at Week 24|Percentage of participants achieving at least a 50% decrease (improvement) from Baseline in the Psoriasis Area and Severity Index (PASI) at Week 24. PASI Score incorporates measures of erythema, desquamation, infiltration, and affected body surface area. Involvement and severity of psoriasis was scored by a blinded assessor using a scale of 0 to 72, where 0 = no psoriasis and 72 = severe disease.|Baseline and 24 Weeks|Intention-to-Treat with available data; last observation carried forward (LOCF) imputation was used.||Percentage of participants|||Number
804880|NCT01001208|Primary|PASI 75 Response at Week 24|Percentage of participants achieving at least a 75% decrease (improvement) from Baseline in the Psoriasis Area and Severity Index (PASI) at Week 24. PASI Score incorporates measures of erythema, desquamation, infiltration, and affected body surface area. Involvement and severity of psoriasis was scored by a blinded assessor using a scale of 0 to 72, where 0 = no psoriasis and 72 = severe disease.|Baseline and 24 Weeks|Intention-to-Treat with available data; last observation carried forward (LOCF) imputation was used.||Percentage of participants|||Number
804881|NCT01001221|Primary|Objective Response Rate With MTD|"Objective response was defined as a confirmed complete response (CR) or a confirmed partial response (PR) during the treatment period, based on RECIST 1.1, as assessed by the Investigator.
CR: Disappearance of all target lesions, all non-target lesions, and no new lesion. Any pathological lymph nodes must have had reduction in the short axis to <10 mm.
PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesion.
The objective response rate (ORR) was to be calculated as the proportion of participants with confirmed objective response relative to the total number of participants in the analysis population. Due to the inability to determine MTD during the study part 1, the analysis was not performed."|Fron Day 1 up to a maximum of 12 months||||||
806267|NCT01012167|Secondary|Laboratory Measures - CO2|Carbon Dioxide (CO2) blood levels by treatment group and visit.|Once during evaluation and once at the end of 6 weeks of study treatment|Available participant lab data for Evaluation and Week 6.||mE/qL||Standard Deviation|Mean
804882|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1: Ratio Day 1/Day 8 for AUClast and AUC|Ratio Day 1/Day 8 for AUClast and AUC were calculated to assess the effect of cabazitaxel on gemcitabine exposure.|Day 1 (7 to 9 timepoints from start of infusion up to 24h hours after the end of infusion) and Day 8 (7 to 9 timepoints from start of infusion up to 24h hours after the end of infusion)|Enrolled participants who received at least 1 part of a dose of study treatment and had valid Day 1 and Day 8 PK samples. Valid PK samples included at least 1 post treatment analyzable PK sample and no prohibited concomitant medications.||ratio||Full Range|Mean
804883|NCT01001221|Secondary|Pharmacokinetic of 2',2' Difluorodeoxyuridine on Cycle 1 Day 8: Area Under the Time Concentration Curve (AUC)||7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined||ng*hr/ml||Standard Deviation|Mean
804884|NCT01001221|Secondary|Pharmacokinetic of 2',2' Difluorodeoxyuridine on Cycle 1 Day 8: Terminal Half-life (t1/2z)||7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined||hours||Standard Deviation|Mean
804885|NCT01001221|Secondary|Pharmacokinetic of 2',2' Difluorodeoxyuridine on Cycle 1 Day 8: Area Under the Time Concentration Curve From Time 0 To the Real Time Tlast (AUClast)||7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined||ng*hr/ml||Standard Deviation|Mean
804886|NCT01001221|Secondary|Pharmacokinetic of 2',2' Difluorodeoxyuridine on Cycle 1 Day 8: Time to Maximum Concentration (Tmax)||7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined||hours||Full Range|Median
804887|NCT01001221|Secondary|Pharmacokinetic of 2',2' Difluorodeoxyuridine on Cycle 1 Day 8: Maximum Plasma Concentration Observed (Cmax)|"Blood samples collected for gemcitabine assay were used to assay gemcitabine metabolite, 2',2' difluorodeoxyuridine(dFdU).
2',2' difluorodeoxyuridine plasma concentrations were determined using validated LC-MS/MS methods with a LLOQ of 50 ng/mL.
PK parameters were calculated from plasma concentrations using non-compartmental analysis."|7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|All enrolled participants who received at least 1 part of a dose of study treatment and had at least 1 post treatment analyzable PK sample and with no prohibited concomitant medications.||ng/ml||Standard Deviation|Mean
804888|NCT01001221|Secondary|Pharmacokinetic of 2',2' Difluorodeoxyuridine on Cycle 1 Day 1: Area Under the Time Concentration Curve (AUC)||7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined. Two participants' assays could not be used in the analysis.||ng*hr/ml||Standard Deviation|Mean
804889|NCT01001221|Secondary|Pharmacokinetic of 2',2' Difluorodeoxyuridine on Cycle 1 Day 1: Terminal Half-life (t1/2z)||7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined||hours||Standard Deviation|Mean
804890|NCT01001221|Secondary|Pharmacokinetic of 2',2' Difluorodeoxyuridine on Cycle 1 Day 1: Area Under the Time Concentration Curve From Time 0 To the Real Time Tlast (AUClast)||7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined||ng*hr/ml||Standard Deviation|Mean
804891|NCT01001221|Secondary|Pharmacokinetic of 2',2' Difluorodeoxyuridine on Cycle 1 Day 1: Time to Maximum Concentration (Tmax)||7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined||hours||Full Range|Median
804892|NCT01001221|Secondary|Pharmacokinetic of 2',2' Difluorodeoxyuridine on Cycle 1 Day 1: Maximum Plasma Concentration Observed (Cmax)|"Blood samples collected for gemcitabine assay were used to assay gemcitabine metabolite, 2',2' difluorodeoxyuridine(dFdU).
2',2' difluorodeoxyuridine plasma concentrations were determined using validated LC-MS/MS methods with a LLOQ of 50 ng/mL.
PK parameters were calculated from plasma concentrations using non-compartmental analysis."|7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined||ng/ml||Standard Deviation|Mean
804893|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 8: Volume of Distribution at Steady State Normalized to Body Surface Area (Vss/BSA)||7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined. Two participants' assays could not be used in the analysis.||L/m^2||Standard Deviation|Mean
804894|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 8: Total Plasma Clearance Normalized to Body Surface Area (CL/BSA)||7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined. Two participants' assays could not be used in the analysis.||L/hr/m^2||Standard Deviation|Mean
804895|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 8: Volume of Distribution at Steady State (Vss)||7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined. Two participants' assays could not be used in the analysis.||L||Standard Deviation|Mean
804896|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 8: Total Plasma Clearance (CL)||7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined. Two participants' assays could not be used in the analysis.||L/hr||Standard Deviation|Mean
804897|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 8: Area Under the Time Concentration Curve (AUC)||7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined. Two participants' assays could not be used in the analysis.||ng*hr/ml||Standard Deviation|Mean
804898|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 8: Terminal Half-life (t1/2z)||7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined. Two participants' assays could not be used in the analysis.||hours (hr)||Standard Deviation|Mean
810712|NCT01048606|Secondary|Physical Activity Level: Physical Activity Scale for the Elderly (PASE)||0, 6 and 12 months||||||
804901|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 8: Maximum Plasma Concentration Observed (Cmax)|"Blood samples for gemcitabine assay were collected on Day 8 of cycle 1 at the following timepoints:
Cabazitaxel + Gemcitabine: prior the start of infusion, immediately before the end of infusion, 15, 30 minutes, 1.5, 3.5 and 22.5 hours after the end of infusion;
Gemcitabine + cabazitaxel: prior the start of infusion, immediately before the end of infusion, 15, 30 minutes, 1, 1.5, 2.5, 9 and 23.5 hours after the end of infusion;
Gemcitabine plasma concentrations were determined using validated LC-MS/MS methods with a LLOQ of 50 ng/mL.
PK parameters were calculated from plasma concentrations using non-compartmental analysis."|7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined||ng/ml||Standard Deviation|Mean
804902|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 1: Volume of Distribution at Steady State Normalized to Body Surface Area (Vss/BSA)||7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined. Five participants' assays could not be used in the analysis.||L/m^2||Standard Deviation|Mean
804903|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 1: Total Plasma Clearance Normalized to Body Surface Area (CL/BSA)||7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined. Five participants' assays could not be used in the analysis.||L/hr/m^2||Standard Deviation|Mean
804904|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 1: Volume of Distribution at Steady State (Vss)||7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined. Five participants' assays could not be used in the analysis.||L||Standard Deviation|Mean
804905|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 1: Total Plasma Clearance (CL)||7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined. Five participants' assays could not be used in the analysis.||L/hr||Standard Deviation|Mean
804906|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 1: Terminal Half-life (t1/2z)||7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined. Five participants' assays could not be used in the analysis.||hours||Standard Deviation|Mean
804907|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 1: Area Under the Time Concentration Curve (AUC)||7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined. Five participants' assays could not be used in the analysis.||ng*hr/ml||Standard Deviation|Mean
804908|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 1: Area Under the Time Concentration Curve From Time 0 To the Real Time Tlast (AUClast)||7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined||ng*hr/ml||Standard Deviation|Mean
804909|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 1: Time to Maximum Concentration (Tmax)||7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined||hours (hr)||Full Range|Median
804910|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 1: Maximum Plasma Concentration Observed (Cmax)|"Blood samples for gemcitabine assay were collected on Day 1 of cycle 1 at the following timepoints:
Cabazitaxel + Gemcitabine: prior the start of cabazitaxel infusion, immediately before the end of gemcitabine infusion, 15, 30 minutes, 1.5, 3.5 and 22.5 hours after the end of gemcitabine infusion;
Gemcitabine + cabazitaxel: prior the start of gemcitabine infusion, immediately before the end of gemcitabine infusion, 15, 30 minutes, 1, 1.5, 2.5, 9 and 23.5 hours after the end of cabazitaxel infusion;
Gemcitabine plasma concentrations were determined using validated LC-MS/MS methods with a LLOQ of 50 ng/mL.
PK parameters were calculated from plasma concentrations using non-compartmental analysis."|7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined.||ng/ml||Standard Deviation|Mean
804911|NCT01001221|Secondary|Pharmacokinetic of Cabazitaxel on Cycle 1: Volume of Distribution at Steady State Normalized to Body Surface Area (Vss/BSA)||before the start of infusion and 5 minutes before the end of infusion, then 5, 15, 30 minutes, 1, 2, 3, 5, 7, 10, 24, 48, 72, 120 and 168 hours after the end of infusion|PK population as previously defined. One participant's assays could not be used for Vss/BSA.||L/m^2||Standard Deviation|Mean
804912|NCT01001221|Secondary|Pharmacokinetic of Cabazitaxel on Cycle 1: Total Plasma Clearance Normalized to Body Surface Area (CL/BSA)||before the start of infusion and 5 minutes before the end of infusion, then 5, 15, 30 minutes, 1, 2, 3, 5, 7, 10, 24, 48, 72, 120 and 168 hours after the end of infusion|PK population as previously defined. Six participants' assays could not be used for CL/BSA.||L/hr/m^2||Standard Deviation|Mean
804913|NCT01001221|Secondary|Pharmacokinetic of Cabazitaxel on Cycle 1: Volume of Distribution at Steady State (Vss)||before the start of infusion and 5 minutes before the end of infusion, then 5, 15, 30 minutes, 1, 2, 3, 5, 7, 10, 24, 48, 72, 120 and 168 hours after the end of infusion|PK population as previously defined. One participant's assay could not be used for Vss.||L||Standard Deviation|Mean
804914|NCT01001221|Secondary|Pharmacokinetic of Cabazitaxel on Cycle 1: Total Plasma Clearance (CL)||before the start of infusion and 5 minutes before the end of infusion, then 5, 15, 30 minutes, 1, 2, 3, 5, 7, 10, 24, 48, 72, 120 and 168 hours after the end of infusion|PK population as previously defined. Six participants' assays could not be used for CL.||L/hr||Standard Deviation|Mean
804915|NCT01001221|Secondary|Pharmacokinetic of Cabazitaxel on Cycle 1: Terminal Half-life (t1/2z)||before the start of infusion and 5 minutes before the end of infusion, then 5, 15, 30 minutes, 1, 2, 3, 5, 7, 10, 24, 48, 72, 120 and 168 hours after the end of infusion|PK population as previously defined||hours (hr)||Standard Deviation|Mean
804916|NCT01001221|Secondary|Pharmacokinetic of Cabazitaxel on Cycle 1: Area Under the Time Concentration Curve (AUC)|Area under the plasma concentration versus time curve extrapolated to infinity|before the start of infusion and 5 minutes before the end of infusion, then 5, 15, 30 minutes, 1, 2, 3, 5, 7, 10, 24, 48, 72, 120 and 168 hours after the end of infusion|PK population as previously defined. Six participants' assays could not be used for AUC.||ng*hr/ml||Standard Deviation|Mean
804917|NCT01001221|Secondary|Pharmacokinetic of Cabazitaxel on Cycle 1: Area Under the Time Concentration Curve From Time 0 To the Real Time Tlast (AUClast)|Area under the plasma concentration versus time curve calculated using the trapezoidal method from time 0 to the last measurable concentration at time t.|before the start of infusion and 5 minutes before the end of infusion, then 5, 15, 30 minutes, 1, 2, 3, 5, 7, 10, 24, 48, 72, 120 and 168 hours after the end of infusion|PK population as previously defined||ng*hr/ml||Standard Deviation|Mean
804918|NCT01001221|Secondary|Pharmacokinetic of Cabazitaxel on Cycle 1: Time to Maximum Concentration (Tmax)||before the start of infusion and 5 minutes before the end of infusion, then 5, 15, 30 minutes, 1, 2, 3, 5, 7, 10, 24, 48, 72, 120 and 168 hours after the end of infusion|PK population as previously defined||hours (hr)||Full Range|Median
804919|NCT01001221|Secondary|Pharmacokinetic of Cabazitaxel on Cycle 1: Maximum Plasma Concentration Observed (Cmax)|"Blood samples for cabazitaxel assay were collected during cycle 1 and cabazitaxel plasma concentrations were determined using a validated liquid chromatography with tandem mass spectometry (LC-MS/MS) method with a lower limit of quantification (LLOQ) of 1 ng/mL.
Pharmacokinetic (PK) parameters were calculated from plasma concentrations using non-compartmental analysis."|before the start of infusion and 5 minutes before the end of infusion, then 5, 15, 30 minutes, 1, 2, 3, 5, 7, 10, 24, 48, 72, 120 and 168 hours after the end of infusion|PK population: All enrolled participants who received at least 1 part of a dose of study treatment and had at least 1 post treatment analyzable PK sample, and with no prohibited concomitant medications||ng/ml||Standard Deviation|Mean
804920|NCT01001221|Post-Hoc|Participant Best Response as Per the Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1|"Participant Best response was assessed by investigator using the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1:
Complete response (CR): Disappearance of all target lesions, all non-target lesions, and no new lesion. Any pathological lymph nodes must have had reduction in the short axis to <10 mm:
Partial response (PR): At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesion;
Progressive disease (PD): >=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of >=1 new lesion and/or unequivocal progression of existing non-target lesions;
Stable disease (SD): not a CR, PR or PD."|Up to a maximum of 22 cycles (median 4 cycles)|all treated (AT) population: All enrolled participants who received at least 1 part of a dose of study treatment.||participants|||Number
804921|NCT01001221|Secondary|Participants With Adverse Events|"Summary of participants with adverse events (AEs) according to severity and relationship to study drug as assessed by the investigator. The National Cancer Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE), version 3.0 was used to grade the severity of AE.
Treatment-emergent adverse events (TEAEs) are AEs that occurred or worsened from start of treatment up to 30 days after treatment ceased.
NCI CTCAE v.3.0 grade 3 =severe and grade 4= life-threatening or disabling."|from first dose of study medication up to 30 days after the last dose of study medication (maximum follow-up of 68 weeks)|all treated (AT) population: All enrolled participants who received at least 1 part of a dose of study treatment||participants|||Number
804922|NCT01001221|Secondary|Duration of Response With MTD|"Duration of Response (DR) was defined as the time from the first documentation of RECIST-defined objective tumor response to the first documentation of RECIST-defined objective tumor progression or death.
Median DR was to be estimated using the Kaplan-Meier method. Due to the inability to determine MTD during the study part 1, the analysis was not performed."|Fron Day 1 up to a maximum of 12 months||||||
804923|NCT01001221|Secondary|Time To Progression With MTD|"Time to progression (TTP) was defined as the time from first treatment administration to first documentation of RECIST-defined objective tumor progression (>=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of >=1 new lesion and/or unequivocal progression of existing non-target lesions).
Median TTP was to be estimated using the Kaplan-Meier method. Due to the inability to determine MTD during the study part 1, the analysis was not performed."|Fron Day 1 up to a maximum of 12 months||||||
804924|NCT01001221|Primary|Participants With Dose Limiting Toxicities During Dose Escalation|Dose Limiting Toxicities (DLTs) were defined as clinical adverse events (AE) or laboratory abnormalities considered drug-related as assessed by the Investigator or Sponsor, and achieving a Common Terminology Criteria for Adverse Events v3.0 (CTCAE) severity rating of severe (3) or life-threatening (4).|Day 1 to Day 21 of the first treatment cycle|"DLT population: All participants who completed assessments for DLT evaluation for Cycle 1 and either:
received study treatment during Cycle 1 and had DLT or
did not have DLT and received a full dose of study treatment (no delay/reduction) during Cycle 1 and did not receive hematopoietic growth factors."||participants|||Number
804925|NCT01001234|Secondary|Pain Relief at 2 Hours Post Dose in Participants Between 6 and 17 Years of Age|Pain intensity was assessed using a 5-Face Pain Scale ranging from 1=no pain to 5=very bad pain. Pain relief was defined as a reduction in severity from a rating of 3, 4 or 5 (moderate or severe pain) at the Stage 2 baseline (15 minutes post Stage 1 dose) to a rating of 2 or 1 (mild or no pain) at 2 hours post Stage 2 dose. Missing data were imputed by carrying forward the preceding Stage 2 pain intensity values. Missing Stage 2 baseline values were imputed by carrying forward the Stage 1 baseline value, if available.|2 hours post Stage 2 dose|Includes participants who did not respond to placebo in Stage 1, were randomized to and took Stage 2 study drug and had both Stage 2 baseline migraine severity (moderate or severe) and at least one post Stage 2 dose efficacy measurement prior to or including the 2 hour post dose time point. Those randomized to rizatriptan in Stage 1 were excluded.||participants|||Number
804926|NCT01001234|Secondary|Pain Freedom at 2 Hours Post Dose in Participants Between 6 and 17 Years of Age|Pain intensity was assessed using a 5-Face Pain Scale ranging from 1=no pain to 5=very bad pain. Pain freedom was defined as a reduction in severity from a rating of 3, 4 or 5 (moderate or severe pain) at the Stage 2 baseline (15 minutes post Stage 1 dose) to a rating of 1 (no pain) at 2 hours post Stage 2 dose. Missing data were imputed by carrying forward the preceding Stage 2 pain intensity values. Missing Stage 2 baseline values were imputed by carrying forward the Stage 1 baseline value, if available.|2 hours post Stage 2 dose|Includes participants who did not respond to placebo in Stage 1, were randomized to and took Stage 2 study drug and had both Stage 2 baseline migraine severity (moderate or severe) and at least one post Stage 2 dose efficacy measurement prior to or including the 2 hour post dose time point. Those randomized to rizatriptan in Stage 1 were excluded.||participants|||Number
804927|NCT01001234|Secondary|Pain Relief at 2 Hours Post Dose in Participants Between 12 and 17 Years of Age|Pain intensity was assessed using a 5-Face Pain Scale ranging from 1=no pain to 5=very bad pain. Pain relief was defined as a reduction in severity from a rating of 3, 4 or 5 (moderate or severe pain) at the Stage 2 baseline (15 minutes post Stage 1 dose) to a rating of 2 or 1 (mild or no pain) at 2 hours post Stage 2 dose. Missing data were imputed by carrying forward the preceding Stage 2 pain intensity values. Missing Stage 2 baseline values were imputed by carrying forward the Stage 1 baseline value, if available.|2 hours post Stage 2 dose|Includes participants who did not respond to placebo in Stage 1, were randomized to and took Stage 2 study drug and had both Stage 2 baseline migraine severity (moderate or severe) and at least one post Stage 2 dose efficacy measurement prior to or including the 2 hour post dose time point. Those randomized to rizatriptan in Stage 1 were excluded.||participants|||Number
804928|NCT01001234|Primary|Pain Freedom at 2 Hours Post Dose in Participants Between 12 and 17 Years of Age|Pain intensity was assessed using a 5-Face Pain Scale ranging from 1=no pain to 5=very bad pain. Pain freedom was defined as a reduction in severity from a rating of 3, 4 or 5 (moderate or severe pain) at the Stage 2 baseline (15 minutes post Stage 1 dose) to a rating of 1 (no pain) at 2 hours post Stage 2 dose. Missing data were imputed by carrying forward the preceding Stage 2 pain intensity values. Missing Stage 2 baseline values were imputed by carrying forward the Stage 1 baseline value, if available.|2 hours post Stage 2 dose|Includes participants who did not respond to placebo in Stage 1, were randomized to and took Stage 2 study drug and had both Stage 2 baseline migraine severity (moderate or severe) and at least one post Stage 2 dose efficacy measurement prior to or including the 2 hour post dose time point. Those randomized to rizatriptan in Stage 1 were excluded.||participants|||Number
804929|NCT01001299|Secondary|Progression-Free Survival (PFS)|PFS was defined the time interval between the date of the first treatment and the date of progression or death from any cause, whichever occurred first. Deaths that occurred in participants without disease progression were to be considered to be a PFS event on the date of death. Participants who neither progressed nor died were to be censored on the date of the last evaluable tumor assessment prior to the data cutoff date. PD, as assessed by investigator, was defined as at least 20% increase in the sum of diameters of target lesions compared to Nadir (smallest sum of diameters on-study), unequivocal progression of existing non-target lesions, or presence of new lesion.|Screening up to approximately 3.5 years (assessed at Screening, Day 1 of cycle 3 thereafter Day 1 of every other cycle [every 2 months] and at end of study)|The data for this outcome measure was not collected as the outcome was removed as per changes in planned analysis (protocol amendment).|||||
804930|NCT01001299|Secondary|Time to Response|Time to response was defined as the interval between the date of the first treatment and the date of the first documentation of confirmed CR or PR (as assessed by investigator), whichever occurred first. CR was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must decrease to normal (short axis <10 mm). PR was defined as a 30% decrease in the sum of the diameters of the target lesions taking as a reference the baseline sum diameter.|Screening up to approximately 3.5 years (assessed at Screening, Day 1 of cycle 3 thereafter Day 1 of every other cycle [every 2 months] and at end of study)|The data for this outcome measure was not collected as the outcome was removed as per changes in planned analysis (protocol amendment).|||||
804931|NCT01001299|Secondary|Duration of Response|Duration of response was defined as the time interval between the date of the earliest qualifying response and the date of disease progression (PD) or death, only for those participants whose best overall response was CR or PR, as assessed by investigator. CR was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must decrease to normal (short axis <10 mm). PR was defined as a 30% decrease in the sum of the diameters of the target lesions taking as a reference the baseline sum diameter. PD was defined as at least 20% increase in the sum of diameters of target lesions compared to Nadir (smallest sum of diameters on-study), unequivocal progression of existing non-target lesions, or presence of new lesion.|Screening up to approximately 3.5 years (assessed at Screening, Day 1 of Cycle 3 thereafter Day 1 of every other cycle [every 2 months] and at end of study)|The data for this outcome measure was not collected as the outcome was removed as per changes in planned analysis (protocol amendment).|||||
804932|NCT01001299|Secondary|Percentage of Participants With a Confirmed Best Overall Response of Complete Response (CR) or Partial Response (PR)|Confirmed best overall response was defined as having best objective response as CR or PR, as assessed by investigator and confirmed at least 28 days after initial response, according to the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1). CR was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must decrease to normal (short axis less than [<] 10 millimeter [mm]). PR was defined as a 30% decrease in the sum of the diameters of the target lesions taking as a reference the baseline sum diameter. Percentage of participants with best overall response of CR or PR are reported.|Screening up to approximately 3.5 years (assessed at Screening, Day 1 of Cycle 3 thereafter Day 1 of every other cycle [every 2 months] and at end of study)|Efficacy population included all enrolled participants who received any vemurafenib and had at least one post-baseline tumor assessment.||percentage of participants|||Number
804933|NCT01001299|Primary|CL/F of Probe Parent Drugs on Day 20|Drug clearance was a quantitative measure of the rate at which a drug substance was removed from the body. Clearance obtained after oral dose was influenced by the fraction of the dose absorbed.|Day 20: 0, 1, 3, 4, 6, 8, 24 hours, additionally for caffeine 0.5, 1.5, 2, 12, 18, 48, 72, 96, 120,dextromethorphan 0.5, 1.5, 2, 12, 18, 48,midazolam 0.08, 0.25, 0.5, 0.75, 2, 10,omeprazole 0.5, 1.5, 2, 2.5, 12, 18,S-warfarin 12, 48, 72, 96, 120 hours|Primary PK analysis population. Number of Participants Analyzed = participants evaluable for this outcome and n = participants evaluable for specified category.||mL/h||Standard Deviation|Mean
804934|NCT01001299|Primary|Apparent Plasma Clearance (CL/F) of Probe Parent Drugs on Day 1|Drug clearance was a quantitative measure of the rate at which a drug substance was removed from the body. Clearance obtained after oral dose was influenced by the fraction of the dose absorbed.|Day 1: 0, 1, 3, 4, 6, 8, 24 hours, additionally for caffeine 0.5, 1.5, 2, 12, 18, 48, 72, 96, 120,dextromethorphan 0.5, 1.5, 2, 12, 18, 48,midazolam 0.08, 0.25, 0.5, 0.75, 2, 10,omeprazole 0.5, 1.5, 2, 2.5, 12, 18,S-warfarin 12, 48, 72, 96, 120 hours|Primary PK analysis population. Number of Participants Analyzed = participants evaluable for this outcome and n = participants evaluable for specified category.||milliliters per hour (mL/h)||Standard Deviation|Mean
804935|NCT01001299|Primary|t1/2 of Probe Parent Drugs and Their Metabolites on Day 20|Timeframe reported for parent probe drug is also applicable for their metabolite except S-warfarin as S-warfarin does not have a metabolite.|Day 20: 0, 1, 3, 4, 6, 8, 24 hours, additionally for caffeine 0.5, 1.5, 2, 12, 18, 48, 72, 96, 120,dextromethorphan 0.5, 1.5, 2, 12, 18, 48,midazolam 0.08, 0.25, 0.5, 0.75, 2, 10,omeprazole 0.5, 1.5, 2, 2.5, 12, 18,S-warfarin 12, 48, 72, 96, 120 hours|Primary PK analysis population. Number of Participants Analyzed = participants evaluable for this outcome.||hours||Standard Deviation|Mean
804936|NCT01001299|Primary|Apparent Elimination Half-Life in Plasma (t1/2) of Probe Parent Drugs and Their Metabolites on Day 1|Timeframe reported for parent probe drug is also applicable for their metabolite except S-warfarin as S-warfarin does not have a metabolite.|Day 1: 0, 1, 3, 4, 6, 8, 24 hours, additionally for caffeine 0.5, 1.5, 2, 12, 18, 48, 72, 96, 120,dextromethorphan 0.5, 1.5, 2, 12, 18, 48,midazolam 0.08, 0.25, 0.5, 0.75, 2, 10,omeprazole 0.5, 1.5, 2, 2.5, 12, 18,S-warfarin 12, 48, 72, 96, 120 hours|Primary PK analysis population. Number of Participants Analyzed = participants evaluable for this outcome.||hours||Standard Deviation|Mean
804937|NCT01001299|Primary|Trough Plasma Concentration (Cmin) of Vemurafenib||Before morning dose (0 hour) on Day 19|Primary PK analysis population. Here, number of participants analyzed signifies participants with evaluable data for this outcome.||mcg/mL||Standard Deviation|Mean
804938|NCT01001299|Primary|Tmax of Vemurafenib||0, 0.5, 1, 2, 4, 8, 12, 13, 14, 16, 18, 24 hours on Day 19|Primary PK analysis population.||hours||Full Range|Median
804939|NCT01001299|Primary|Tmax of Probe Parent Drugs and Their Metabolites on Day 20|Timeframe reported for parent probe drug is also applicable for their metabolite except S-warfarin as S-warfarin does not have a metabolite.|Day 20: 0, 1, 3, 4, 6, 8, 24 hours, additionally for caffeine 0.5, 1.5, 2, 12, 18, 48, 72, 96, 120,dextromethorphan 0.5, 1.5, 2, 12, 18, 48,midazolam 0.08, 0.25, 0.5, 0.75, 2, 10,omeprazole 0.5, 1.5, 2, 2.5, 12, 18,S-warfarin 12, 48, 72, 96, 120 hours|Primary PK analysis population. Number of Participants Analyzed = participants evaluable for this outcome and n = participants evaluable for specified category.||hours||Full Range|Median
804940|NCT01001299|Primary|Time to Reach Maximum Plasma Concentration (Tmax) of Probe Parent Drugs and Their Metabolites on Day 1|Timeframe reported for parent probe drug is also applicable for their metabolite except S-warfarin as S-warfarin does not have a metabolite.|Day 1: 0, 1, 3, 4, 6, 8, 24 hours, additionally for caffeine 0.5, 1.5, 2, 12, 18, 48, 72, 96, 120,dextromethorphan 0.5, 1.5, 2, 12, 18, 48,midazolam 0.08, 0.25, 0.5, 0.75, 2, 10,omeprazole 0.5, 1.5, 2, 2.5, 12, 18,S-warfarin 12, 48, 72, 96, 120 hours|Primary PK analysis population. Number of Participants Analyzed = participants evaluable for this outcome and n = participants evaluable for specified category.||hours||Full Range|Median
804941|NCT01001299|Primary|Cmax of Vemurafenib||0, 0.5, 1, 2, 4, 8, 12, 13, 14, 16, 18, 24 hours on Day 19|Primary PK analysis population.||micrograms per milliliter (mcg/mL)||Standard Deviation|Mean
804942|NCT01001299|Primary|Cmax of Probe Parent Drugs and Their Metabolites on Day 20|Timeframe reported for parent probe drug is also applicable for their metabolite except S-warfarin as S-warfarin does not have a metabolite.|Day 20: 0, 1, 3, 4, 6, 8, 24 hours, additionally for caffeine 0.5, 1.5, 2, 12, 18, 48, 72, 96, 120,dextromethorphan 0.5, 1.5, 2, 12, 18, 48,midazolam 0.08, 0.25, 0.5, 0.75, 2, 10,omeprazole 0.5, 1.5, 2, 2.5, 12, 18,S-warfarin 12, 48, 72, 96, 120 hours|Primary PK analysis population. Number of Participants Analyzed = participants evaluable for this outcome and n = participants evaluable for specified category.||ng/mL||Standard Deviation|Mean
804943|NCT01001299|Primary|Cmax of Probe Parent Drugs and Their Metabolites on Day 1|Timeframe reported for parent probe drug is also applicable for their metabolite except S-warfarin as S-warfarin does not have a metabolite.|Day 1: 0, 1, 3, 4, 6, 8, 24 hours, additionally for caffeine 0.5, 1.5, 2, 12, 18, 48, 72, 96, 120,dextromethorphan 0.5, 1.5, 2, 12, 18, 48,midazolam 0.08, 0.25, 0.5, 0.75, 2, 10,omeprazole 0.5, 1.5, 2, 2.5, 12, 18,S-warfarin 12, 48, 72, 96, 120 hours|Primary PK analysis population. Number of Participants Analyzed = participants evaluable for this outcome and n = participants evaluable for specified category.||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
804944|NCT01001299|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to 8, 12, and 24 Hours (AUC[0-8], AUC[0-12], AUC[0-24]) of Vemurafenib|Area under the plasma concentration-time curve calculated using the linear trapezoidal rule from time zero to 8, 12, and 24 hours (AUC[0-8], AUC[0-12], AUC[0-24], respectively).|0, 0.5, 1, 2, 4, 8, 12, 13, 14, 16, 18, 24 hours on Day 19|Primary PK analysis population.||micrograms*hour/milliliter (mcg*h/mL)||Standard Deviation|Mean
804945|NCT01001299|Primary|AUC(0-last) and AUC(0-inf) of Probe Parent Drugs and Their Metabolites on Day 20|AUC(0-last) was defined as the area under the plasma concentration-time curve calculated using the linear trapezoidal rule from time zero to the last observed sampling time. AUC(0-inf) was defined as the area under the plasma concentration-time curve calculated using the linear trapezoidal rule from time zero extrapolated to infinity. Timeframe reported for parent probe drug is also applicable for their metabolite except S-warfarin, as S-warfarin does not have a metabolite.|Day 20: 0, 1, 3, 4, 6, 8, 24 hours, additionally for caffeine 0.5, 1.5, 2, 12, 18, 48, 72, 96, 120,dextromethorphan 0.5, 1.5, 2, 12, 18, 48,midazolam 0.08, 0.25, 0.5, 0.75, 2, 10,omeprazole 0.5, 1.5, 2, 2.5, 12, 18,S-warfarin 12, 48, 72, 96, 120 hours|Primary PK analysis population. Number of Participants Analyzed = participants evaluable for this outcome and n = participants evaluable for specified category.||ng*hr/mL||Standard Deviation|Mean
804946|NCT01001299|Primary|AUC(0-last) and Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC[0-inf]) of Probe Parent Drugs and Their Metabolites on Day 1|AUC(0-last) was defined as the area under the plasma concentration-time curve calculated using the linear trapezoidal rule from time zero to the last observed sampling time. AUC(0-inf) was defined as the area under the plasma concentration-time curve calculated using the linear trapezoidal rule from time zero extrapolated to infinity. Timeframe reported for parent probe drug is also applicable for their metabolite except S-warfarin, as S-warfarin does not have a metabolite.|Day 1: 0, 1, 3, 4, 6, 8, 24 hours, additionally for caffeine 0.5, 1.5, 2, 12, 18, 48, 72, 96, 120,dextromethorphan 0.5, 1.5, 2, 12, 18, 48,midazolam 0.08, 0.25, 0.5, 0.75, 2, 10,omeprazole 0.5, 1.5, 2, 2.5, 12, 18,S-warfarin 12, 48, 72, 96, 120 hours|Primary PK analysis population. Number of Participants Analyzed = participants evaluable for this outcome and n = participants evaluable for specified category.||nanograms*hour per milliliter (ng*hr/mL)||Standard Deviation|Mean
806268|NCT01012167|Secondary|Laboratory Measures - Chloride|Chloride blood levels by treatment group and visit.|Once during evaluation and once at the end of 6 weeks of study treatment|Available participant lab data for Evaluation and Week 6.||mE/qL||Standard Deviation|Mean
804947|NCT01001299|Primary|Geometric Mean Ratio of AUC(0-last) and Cmax of Metabolites of Probe Parent Drugs|AUC(0-last) was defined as the area under the plasma concentration-time curve calculated using the linear trapezoidal rule from time zero to the last observed sampling time. To assess the potential for drug-drug interactions, the geometric mean ratios and corresponding 90% CI of AUC(0-last) and Cmax of metabolites of parent probe drug before (Day 1) and after treatment with vemurafenib (Day 20) was calculated. Ratio and corresponding 90% CI of AUC(0-last) and Cmax (Day 20/Day 1) for each of the 4 probe drug metabolites is reported (paraxanthine [caffeine metabolite], dextrorphan [dextromethorphan metabolite], OH-midazolam [midazolam metabolite], OH-omeprazole (omeprazole metabolite); S-warfarin does not have a metabolite).|Day 1, 20: 0, 1, 3, 4, 6, 8, 24 hours, additionally for paraxanthine 0.5, 1.5, 2, 12, 18, 48, 72, 96, 120, dextrorphan 0.5, 1.5, 2, 12, 18, 48, OH-midazolam 0.08, 0.25, 0.5, 0.75, 2, 10, OH-omeprazole 0.5, 1.5, 2, 2.5, 12, 18 hours|Primary PK analysis population. Number of Participants Analyzed = participants evaluable for this outcome and n = participants evaluable for specified category.||ratio||90% Confidence Interval|Geometric Mean
804948|NCT01001299|Primary|Geometric Mean Ratio of Maximum Plasma Concentration (Cmax) of Probe Parent Drugs|To assess the potential for drug-drug interactions, the geometric mean ratios and corresponding 90% CI of Cmax of parent probe drug before (Day 1) and after treatment with vemurafenib (Day 20) was calculated. Ratio and corresponding 90% CI of Cmax (Day 20/Day 1) for each of the 5 probe drugs is reported.|Day 1, 20: 0, 1, 3, 4, 6, 8, 24 hours, additionally for caffeine 0.5, 1.5, 2, 12, 18, 48, 72, 96, 120,dextromethorphan 0.5, 1.5, 2, 12, 18, 48,midazolam 0.08, 0.25, 0.5, 0.75, 2, 10,omeprazole 0.5, 1.5, 2, 2.5, 12, 18,S-warfarin 12, 48, 72, 96, 120 hours|Primary PK analysis population. Number of Participants Analyzed = participants evaluable for this outcome and n = participants evaluable for specified category.||ratio||90% Confidence Interval|Geometric Mean
804949|NCT01001299|Primary|Geometric Mean Ratio of Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Observed Sampling Time (AUC[0-last]) of Probe Parent Drugs|AUC(0-last) was defined as the area under the plasma concentration-time curve calculated using the linear trapezoidal rule from time zero to the last observed sampling time. To assess the potential for drug-drug interactions, the geometric mean ratios and corresponding 90 percent (%) confidence interval (CI) of AUC(0-last) of parent probe drug before (Day 1) and after treatment with vemurafenib (Day 20) was calculated. Ratio and corresponding 90% CI of AUC(0-last) (Day 20/Day 1) for each of the 5 probe drugs is reported.|Day 1, 20: 0, 1, 3, 4, 6, 8, 24 hours, additionally for caffeine 0.5, 1.5, 2, 12, 18, 48, 72, 96, 120,dextromethorphan 0.5, 1.5, 2, 12, 18, 48,midazolam 0.08, 0.25, 0.5, 0.75, 2, 10,omeprazole 0.5, 1.5, 2, 2.5, 12, 18,S-warfarin 12, 48, 72, 96, 120 hours|Primary pharmacokinetic (PK) population: all participants who received all planned doses of vemurafenib without dose modification/interruption up to Day 25 and all doses of 5 cocktail probes, without major protocol violation. Number of Participants Analyzed=participants evaluable for this outcome; n=participants evaluable for specified category.||ratio||90% Confidence Interval|Geometric Mean
804950|NCT01001325|Primary|Number of pH1N1 Influenza Infections as Diagnosed by PCR From Mid-turbinate Swab|Influenza infection (pH1N1) as diagnosed by PCR from self-collected mid-turbinate swab. Participant is asked to collect a swab when they have symptoms possibly compatible with an acute viral respiratory illness: 1) fever without another obvious source, 2) at least two new respiratory symptoms (runny or stuffy nose, sneezing, sore or scratchy throat, hoarseness, cough), or 3) one respiratory symptom (as above) and one systemic symptom (fever, malaise, muscle aches, headache, fatigue)|day +7 post seasonal influenza vaccination (or placebo) to end of study|||participants||95% Confidence Interval|Number
804951|NCT01001377|Secondary|Number of Participants With Adverse Events (AEs)|Serious adverse events include any event that is fatal, life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or other significant medical hazard. Treatment-related AEs are those the investigator considered as a reasonable possibility to have been caused by study drug.|From the day of the first dose of study therapy through 30 days since the last dose. Maximum time on study treatment was 130 weeks.|Safety Analysis Set (randomized participants who received at least 1 dose of study medication). Five participants who received the incorrect study medication (4 assigned to panitumumab but received cetuximab and 1 assigned to cetuximab but received panitumumab) were included in different treatment arms for safety analyses.||participants|||Number
804952|NCT01001377|Secondary|Change From Baseline in NCCN FCSI Functional Well-being Scale Score|The FCSI consists of 9 questions comprising the most important symptoms associated with colorectal cancer, including energy, pain, weight, diarrhea, nausea, swelling or cramps in the stomach area, appetite, ability to enjoy life, and overall quality of life. The 9 questions are combined in three algorithms to provide information for 3 domains: colorectal cancer symptoms, physical well-being, and functional well-being. Each of the 9 items are scored from “0” to “4” representing “Not at All” through to “Very Much True”. The raw score for all items is transformed to a 0-100 scale, and the average for each of the 3 subscales is calculated; high scores illustrate an improved state (e.g. able to enjoy life more).|From Study Day 1 through the last day of treatment or disease progression, up to Week 85.|Patient reported outcomes (PRO) analysis set participants with available data.||scores on a scale||95% Confidence Interval|Least Squares Mean
804953|NCT01001377|Secondary|Change From Baseline in NCCN FCSI Physical Well-being Scale Score|"The FCSI consists of 9 questions comprising the most important symptoms associated with colorectal cancer, including energy, pain, weight, diarrhea, nausea, swelling or cramps in the stomach area, appetite, ability to enjoy life, and overall quality of life. The 9 questions are combined in three algorithms to provide information for 3 domains: colorectal cancer symptoms, physical well-being, and functional well-being. Each of the 9 items are scored from 0 to 4 representing Not at All through to Very Much True. The raw score for all items is transformed to a 0-100 scale, and the average for each of the 3 subscales is calculated; high scores illustrate an improved state (e.g. able to enjoy life more)."|From Study Day 1 through the last day of treatment or disease progression, up to Week 85.|Patient reported outcomes (PRO) analysis set participants with available data.||scores on a scale||95% Confidence Interval|Least Squares Mean
805005|NCT01001702|Secondary|Number of Participants With Clinically Significant Heart Rate|Heart rate was measured at Baseline and at each visit supine (lying on the back) and standing. A heart rate increase is an increase of ≥ 15 beats per minute (bpm) compared to Baseline. A heart rate decrease is a decrease of ≥ 15 bpm compared to Baseline.|Baseline, Up to 72 months|Participants with baseline assessment and at least one post-baseline numeric result for the given parameter.||Participants|||Number
804954|NCT01001377|Secondary|Change From Baseline in National Comprehensive Cancer Network Functional Assessment of Cancer Therapy Colorectal Symptom Index (NCCN FCSI ) Symptoms Score|The FCSI consists of 9 questions comprising the most important symptoms associated with colorectal cancer, including energy, pain, weight, diarrhea, nausea, swelling or cramps in the stomach area, appetite, ability to enjoy life, and overall quality of life. The 9 questions are combined in three algorithms to provide information for 3 domains: colorectal cancer symptoms, physical well-being, and functional well-being. Each of the 9 items are scored from “0” to “4” representing “Not at All” through to “Very Much True”. The raw score for all items is transformed to a 0-100 scale, and the average for each of the 3 subscales is calculated; high scores illustrate an improved state (e.g. able to enjoy life more).|From Study Day 1 through the last day of treatment or disease progression, up to Week 85.|Patient reported outcomes (PRO) analysis set participants with available data.||scores on a scale||95% Confidence Interval|Least Squares Mean
804955|NCT01001377|Secondary|Change From Baseline in EuroQOL 5 Dimension (EQ-5D) Visual Analog Scale (VAS)|The EQ-5D is a standardized instrument for use as a generic measure of health outcome. The VAS asks respondents to rate their present health status on a 0 - 100 scale, with 0 labeled as “Worst imaginable health state” and 100 labeled as “Best imaginable health state.” The VAS score is determined by observing the point at which the participant's hand drawn line intersects the scale.|From Study Day 1 through the last day of treatment or disease progression, up to Week 85.|Patient reported outcomes (PRO) analysis set participants with available data||scores on a scale||95% Confidence Interval|Least Squares Mean
804956|NCT01001377|Secondary|Change From Baseline in EuroQOL 5 Dimension (EQ-5D) Health State Index Score|The EQ-5D is a standardized instrument for use as a generic measure of health outcome. The health state index measures the following 5 health dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension contains 3 levels of response to reflect degree of problems participants have experienced: no problem (1), some problem (2) and extreme problems (3). The health states for each respondent are converted into a single index number using a specified set of weights. Resulting scores can range from 1.0 and –0.594. A higher score indicates a more preferred health status with 1.0 representing perfect health and 0 representing death. Negative scores are possible and represent health states regarded as less preferable than death (0). Repeated measures mixed model includes treatment, geographic region, ECOG score, assessment week, and treatment by assessment week interaction as fixed effects, and participants a random effect.|From Study Day 1 through the last day of treatment or disease progression, up to Week 85.|Patient reported outcomes (PRO) analysis set: all participants in the primary analysis set who have a Baseline and at least one follow-up PRO assessment prior to clinical or objective disease progression per RECIST version 1.1. Participants with available data are included.||scores on a scale||95% Confidence Interval|Least Squares Mean
804957|NCT01001377|Secondary|Time to Treatment Failure|Time to treatment failure (TTF) is the time from randomization date to date that the decision was made to end the treatment period for any reason; participants who remained in the treatment period at the time of analysis were censored at the date of the last on-study assessment.|From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.|Primary analysis set||months||95% Confidence Interval|Median
804958|NCT01001377|Secondary|Time to Response|Time to response (TTR), calculated for those participants with an objective response, is defined as the time from the randomization date to the date of first objective response.|From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.|Participants with an objective response||months||Inter-Quartile Range|Median
804959|NCT01001377|Secondary|Duration of Response|Duration of response (DOR), calculated only for those participants with an objective response, is the time from first objective response to disease progression per the RECIST v1.1 or death. Participants not meeting criteria for progression or who died by the analysis data cutoff date were censored at their last evaluable disease assessment date.|From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.|Participants with an objective response||months||95% Confidence Interval|Median
804960|NCT01001377|Secondary|Objective Response|Objective response is either a complete response (CR) or partial response (PR) per RECIST version 1.1. All participants that did not meet the criteria for an objective response by the analysis cut-off date were considered non-responders. CR: Disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm, and disappearance of all non-target lesions, and no new lesions. PR: Disappearance of all target lesions, persistence of one or more non-target lesions not qualifying for either CR or progressive disease, or, at least a 30% decrease in the sum of diameters of target lesions with no unequivocal progression of existing non-target lesions and no new lesions.|From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.|Tumor Response Analysis Set: Participants in the primary analysis set with at least 1 Baseline unidimensionally measurable lesion per RECIST version 1.1.||percentage of participants||95% Confidence Interval|Number
804961|NCT01001377|Secondary|Progression-free Survival|"Progression free survival (PFS) is the time from the date of randomization to the date of disease progression per the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 or death. Participants alive and not meeting criteria for progression by the analysis data cut-off date were censored at their last evaluable disease assessment date.
Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study based on all target lesions recorded since the treatment started (the sum must also demonstrate an absolute increase of at least 5 mm), or unequivocal progression of existing non-target lesions, or any new lesions."|From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.|Primary analysis set||months||95% Confidence Interval|Median
804962|NCT01001377|Primary|Overall Survival|Overall survival is the time from the date of randomization until the date of death. Participants who had not died by the analysis data cut-off date were censored at their last contact date.|From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.|Primary Analysis Set: All participants who were randomized and who received at least 1 dose of panitumumab or cetuximab; analyzed according to randomized treatment arm.||months||95% Confidence Interval|Median
805041|NCT01002287|Secondary|Mobilization Time|The time (minute) required to incise and mobilize the ileal loop in preparation for reanastomosis for ileostomy closure.|average 10-12 weeks post surgery|All 11 patients meet the per protocol population defined in the protocol and the statistical analysis plan.||minutes||Standard Deviation|Mean
804963|NCT01001390|Secondary|Number of Participants With Improvement in Gait Efficiency While Using an AFO|The difference of net oxygen consumption between wearing AFO and without wearing AFO (difference = wearing AFO - without wearing AFO) will be compared between the baseline study and one month later by using repeated measures analysis in which the effect of time will be tested controlling for other confounding variables.|One month after baseline evaluation|No data was collected for analysis. Two participants were enrolled, however, neither participant agreed to wear an ankle foot orthoses.|||||
804964|NCT01001390|Primary|Net Oxygen Consumption During the Six Minute Walk Test Among Study Participants Under the Two Walking Conditions, With and Without AFO.|Net oxygen consumption is calculated by the formula: [net oxygen consumption = walking oxygen consumption - sitting oxygen consumption], then adjusted by total mass in kg, including body mass, the mass of the socks, appropriate shoes, helmet, mouth piece system, and for the with AFO trials, the mass of the brace.|Baseline|No data was collected for analysis. Two participants were enrolled, however, neither participant agreed to wear an ankle foot orthoses.|||||
804965|NCT01001403|Primary|Number of Participants With Moderate and Severe Postreperfusion Syndrome (PRS)|Before entering the study, we re-defined the criteria of PRS. From our clinical experiences, two types of PRS were observed according to its severity and treatment option. “Moderate” PRS was identical to previously defined PRS: more than 30% decrease of mean arterial pressure lasting over 1 min was observed within 5 min after reperfusion of the liver graft. However, we differentiated a “severe” form of PRS, in which MAP rapidly fell below 40 mmHg, from the moderate one, because severe PRS required prompt intervention to prevent a permanent damage of vital organs.|during 5 min after reperfusion of liver graft|||participants|||Number
804966|NCT01001429|Secondary|Hemodynamic Stability Post Operatively in PACU|heart rate recorded at 30 min intervals in PACU up to 120 min|PACU to 2 hours post op|||beats per minute||Inter-Quartile Range|Mean
804967|NCT01001429|Secondary|Post Operative Hemodynamic Stability|blood pressure documented at 30 minute intervals in PACU up to 120 min|2 hours in PACU|||mmHg||Inter-Quartile Range|Mean
804968|NCT01001429|Secondary|Patient Satisfaction|1=very poor, 2=poor, 3=fair, 4=very good, 5=excellent|measured prior to discharge up to 2 hours|||units on a scale||Full Range|Mean
804969|NCT01001429|Secondary|Surgeon Satisfaction for Adequate Sedation at Completion of Procedure|surgeon satisfaction graded on numerical scale 1=very poor. 2=poor, 3=fair 4=good, 5=excellent|immediately following the completion of the procedure up to one hour|||units on a scale||Full Range|Mean
804970|NCT01001429|Secondary|Surgeon Satisfaction for Adequate Sedation|1=very poor, 2=poor,3=fair, 4=good, 5=excellent|at 10 minutes into the procedure|||units on a scale||Full Range|Mean
804971|NCT01001429|Primary|Intraoperative Heart Rate Stability|Heart rate recorded at 5 minute intervals during surgery up to 120 min and averaged per study arm|Intraoperative up to 120 min|||beats per minute||Full Range|Mean
804972|NCT01001429|Primary|Intraoperative Respiratory Stability|respiratory rate data were recorded at 5 minutes intervals throughout the surgical procedure up to 120 mins for both groups and averaged per study arm|Intraoperative up to 120 min|||breaths per minute||Full Range|Mean
804973|NCT01001429|Primary|Intraoperative Hemodynamic Stability|systolic and diastolic blood pressure was recorded at 5 minute intervals up to 120 min and were averaged per study arm|Intraoperative up to 120 min|||mm/Hg||Inter-Quartile Range|Mean
804974|NCT01001429|Secondary|"Time to Achieve Street Fitness"|Subjects will be kept in the Post Anesthesia Care Unit (PACU) for a period of 2 hours. However it will be documented as to when, in the opinion of the PACU staff, the subject has met the criteria for discharge.|for 2 hours post-operatively in Post Anesthesia Care unit|Subjects meet criteria for discharge based upon the assessment from a professional independent of the study||minutes||Inter-Quartile Range|Mean
804975|NCT01001429|Primary|Adequate Sedation Via Bispectral Index Score (BIS)and University of Michigan Sedation Scale (UMSS)|Bispectral Index Score measurement uses processed electroencephalogram signals to measure sedation depth of a scale from 0-100 (0=coma; 40-60=general anesthesia;60-90 sedated;100=awake) University of Michigan Sedation Scale (1-4) is an observational scale that quantifies sedation.1=normal response to verbal stimuli, 2=conscious sedation, responsive to tactile stimuli, 3= deeply sedated responsive to repeated or painful stimuli, 4=general anesthesia: not arousable.|Intraoperative up to 120 min|||units on a scale||Inter-Quartile Range|Mean
804976|NCT01001494|Secondary|Percentage of Patients Who Achieved at Least a 4-unit Decrease From Baseline in the SGRQ Total Score at Week 24 on Treatment|Number of patients who achieved a clinically meaningful improvement (≥4-units) in Saint George Respiratory Questionnaire (SGRQ) total score at week 24 on treatment|Week 24|Intention-to-treat (ITT) population: all randomised patients who took at least one dose of Investigational Medicinal Product and who had a baseline and at least 1 post-baseline FEV1 assessment.||Percentage of participants|||Number
804977|NCT01001494|Secondary|Percentage of Patients Who Achieved at Least a 1-unit Decrease From Baseline in TDI Focal Score at Week 24 on Treatment|Number of patients achieving a clinically meaningful improvement (≥1-unit) in Transition Dyspnoea Index (TDI) focal score at Week 24 on Treatment|Week 24|Intention-to-treat (ITT) population: all randomised patients who took at least one dose of Investigational Medicinal Product and who had a baseline and at least 1 post-baseline FEV1 assessment.||Percentage of participants|||Number
804978|NCT01001494|Secondary|Change From Baseline in Peak Forced Expiratory Volume in the First Second (FEV1) at Week 24 on Treatment||Baseline and Week 24|Intention-to-treat (ITT) population: all randomised patients who took at least one dose of Investigational Medicinal Product and who had a baseline and at least 1 post-baseline FEV1 assessment.||Liters||Standard Error|Least Squares Mean
804979|NCT01001494|Primary|Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in the First Second (FEV1) at Week 12 on Treatment||Baseline and Week 12|Intention-to-treat (ITT) population: all randomised patients who took at least one dose of Investigational Medicinal Product and who had a baseline and at least 1 post-baseline FEV1 assessment.||Liters||Standard Error|Least Squares Mean
804980|NCT01001494|Primary|Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in the First Second (FEV1) at Week 24 on Treatment||Baseline and Week 24|Intention-to-treat (ITT) population: all randomised patients who took at least one dose of Investigational Medicinal Product and who had a baseline and at least 1 post-baseline FEV1 assessment.||Liters||Standard Error|Least Squares Mean
806269|NCT01012167|Secondary|Laboratory Measures - Potassium|Potassium blood levels by treatment group and visit.|Once during evaluation and once at the end of 6 weeks of study treatment|Available participant lab data at Evaluation and Week 6.||mE/qL||Standard Deviation|Mean
804981|NCT01001520|Primary|"Measure of Brain Activity: Blood Oxygen Level Dependent (BOLD) fMRI Signal Change During the N-back Working Memory Task (Brain Region: Ventromedial Prefrontal Cortex; vmPFC)"|"Subjects completed two, 11-day study medication periods (one taking active tolcapone; one taking placebo). On Day 8 of each period, after at least 24 hours of smoking abstinence, subjects had an fMRI scan to measure changes in brain activity that occur during a memory test. The subjects completed a commonly used working memory test referred to as the N-back. This test presented complex geometric figures on a projection screen for 0.5 seconds; each figure is separated by 2.5 seconds of black screen. There were 4 conditions requiring increasing memory demands: 0-back, 1-back, 2-back, & 3-back. Subjects had to respond to the target geometric figure that was separated by 0, 1, 2, or 3 figures before it is repeated. Between each condition, there was a brief rest period.
To identify brain signal change, we calculated the difference in the amount of brain activity detected by the fMRI scan for each condition compared to the rest periods. This was a within-subject analysis."|At fMRI scan sessions - Days 8 and 29|See previous sections.||BOLD signal||Standard Error|Mean
804982|NCT01001520|Primary|"Measure of Brain Activity: Blood Oxygen Level Dependent (BOLD) fMRI Signal Change During the N-back Working Memory Task (Brain Region: Posterior Cingulate Cortex; PCC)"|"Subjects completed two, 11-day study medication periods (one taking active tolcapone; one taking placebo). On Day 8 of each period, after at least 24 hours of smoking abstinence, subjects had an fMRI scan to measure changes in brain activity that occur during a memory test. The subjects completed a commonly used working memory test referred to as the N-back. This test presented complex geometric figures on a projection screen for 0.5 seconds; each figure is separated by 2.5 seconds of black screen. There were 4 conditions requiring increasing memory demands: 0-back, 1-back, 2-back, & 3-back. Subjects had to respond to the target geometric figure that was separated by 0, 1, 2, or 3 figures before it is repeated. Between each condition, there was a brief rest period.
To identify brain signal change, we calculated the difference in the amount of brain activity detected by the fMRI scan for each condition compared to the rest periods. This was a within-subject analysis."|At fMRI scan sessions - Days 8 and 29|See previous sections.||BOLD signal||Standard Error|Mean
804983|NCT01001520|Primary|"Measure of Brain Activity: Blood Oxygen Level Dependent (BOLD) fMRI Signal Change During the N-back Working Memory Task (Brain Region: Dorsal Cingulate/Medial Prefrontal Cortex; MF/CG)"|"Subjects completed two, 11-day study medication periods (one taking active tolcapone; one taking placebo). On Day 8 of each period, after at least 24 hours of smoking abstinence, subjects had an fMRI scan to measure changes in brain activity that occur during a memory test. The subjects completed a commonly used working memory test referred to as the N-back. This test presented complex geometric figures on a projection screen for 0.5 seconds; each figure is separated by 2.5 seconds of black screen. There were 4 conditions requiring increasing memory demands: 0-back, 1-back, 2-back, & 3-back. Subjects had to respond to the target geometric figure that was separated by 0, 1, 2, or 3 figures before it is repeated. Between each condition, there was a brief rest period.
To identify brain signal change, we calculated the difference in the amount of brain activity detected by the fMRI scan for each condition compared to the rest periods. This was a within-subject analysis."|At fMRI scan sessions - Days 8 and 29|See previous sections.||BOLD signal||Standard Error|Mean
804984|NCT01001520|Primary|"Measure of Brain Activity: Blood Oxygen Level Dependent (BOLD) fMRI Signal Change During the N-back Working Memory Task (Brain Region: Left Dorsolateral Prefrontal Cortex; Left DLPFC)"|"Subjects completed two, 11-day study medication periods (one taking active tolcapone; one taking placebo). On Day 8 of each period, after at least 24 hours of smoking abstinence, subjects had an fMRI scan to measure changes in brain activity that occur during a memory test. The subjects completed a commonly used working memory test referred to as the N-back. This test presented complex geometric figures on a projection screen for 0.5 seconds; each figure is separated by 2.5 seconds of black screen. There were 4 conditions requiring increasing memory demands: 0-back, 1-back, 2-back, & 3-back. Subjects had to respond to the target geometric figure that was separated by 0, 1, 2, or 3 figures before it is repeated. Between each condition, there was a brief rest period.
To identify brain signal change, we calculated the difference in the amount of brain activity detected by the fMRI scan for each condition compared to the rest periods. This was a within-subject analysis."|At fMRI scan sessions - Days 8 and 29|See previous sections.||BOLD signal||Standard Error|Mean
804985|NCT01001520|Secondary|Subjective Symptoms: Withdrawal Symptoms|"Subjective symptoms were assessed during each in-person session throughout each study medication period. During each visit, we asked subjects to complete the Minnesota Nicotine Withdrawal Scale - Revised version (MNWS). The scale assesses eight DSM-IV items of nicotine withdrawal. The range of possible total scores on the MNWS is 0-60, with higher values indicating an increased nicotine withdrawal. This range of scores represent a total score; there are no subscales. The MNWS-N (right now/at the moment) was assessed during each fMRI scanning session visit (Day 8).
To assess if tolcapone (vs. placebo) affect withdrawal symptoms, we statistically analyzed the average of the total MNWS scores across, all 20 subjects, for each study medication period. Specifically, we analyzed for significant differences between reported withdrawal symptoms while taking tolcapone vs. taking placebo."|Day 8 of each study period|29 subjects completed both fMRI scan sessions; however, data from 9 subjects were excluded from analysis, due to either poor fMRI data quality, low task accuracy (defined as task scores falling two standard deviations below the mean), or a failure to respond to more than 30% of the task's items. Below, we report on the 20 remaining subjects.||units on a scale||Standard Deviation|Mean
804994|NCT01001559|Secondary|Length of Time to Peak Response, as Determined by the Clinical Global Impression of Severity (CGI-S) Scale|"The Clinical Global Impression of Severity (CGI-S) Rating evaluates the severity of individual symptoms and treatment response in patients with mental disorders. The CGI-S is a 7-point scale that that requires the clinician to rate the severity of the patient’s illness at the time of assessment. A rating of 1 is considered normal, or with the least severe symptoms, a rating of 7 is extremely ill, or the worst symptoms.
Median times to peak response. Peak response defined as the first improvement of two or more in the CGI-S from initial visit, and measured the time to the occurrence."|60 days|All participants||Days||Inter-Quartile Range|Median
805044|NCT01002287|Primary|The Incidence of Adhesions, Defined as the Proportion of Subjects Presenting at the Follow-up Surgery (10-12 Weeks) With One or More Adhesions to the Midline Incision, Regardless of Extent and/or Severity.||10-12 Weeks post Initial Surgery for J-Pouch|All 11 patients met the per protocol population requirements specified in the protocol and statistical analysis plan.||percentage of subjects with adhesions|||Number
804986|NCT01001520|Secondary|Subjective Symptoms: Cigarette Craving|"Subjective symptoms were assessed during each in-person session throughout each study medication period. During each visit, we asked subjects to complete the Questionnaire for Smoking Urges-Brief (QSU-B). Specifically, subjects completed the QSU-B at day 5, day 8 (fMRI scanning session 1), day 26 (day 5 of study medication period 2), and day 29 (day 8 of study medication period 2; fMRI scanning session 2).
The range of possible scores on the QSU-B is 10-70, with higher values indicating an increased craving for cigarettes. This range of scores represent a total score; there are no subscales.
While the QSU-B was collected at all in-person sessions, we only analyzed the scores collected from the fMRI scanning sessions of each period (day 8 and day 29). To analyze, we averaged the total scores across all 20 subjects from each fMRI scanning session and statistically analyzed for significant differences between these two averages. This was a within-subject analysis."|Day 8 (fMRI scanning session) of each study period|29 subjects completed both fMRI scan sessions; however, data from 9 subjects were excluded from analysis, due to either poor fMRI data quality, low task accuracy (defined as task scores falling two standard deviations below the mean), or a failure to respond to more than 30% of the task's items. Below, we report on the 20 remaining subjects||units on a scale||Standard Deviation|Mean
804987|NCT01001520|Secondary|Subjective Symptoms: Smoking Behavior|In order to determine if tolcapone (vs. placebo) would affect subject smoking behavior, we collected the daily number of cigarettes each subject smoked from Days 1 through 7 during each study medication period. This allowed us to calculate the average number of daily cigarettes smoked, across all subjects, during each study medication period (i.e., the average number of cigarettes/day smoked while all subjects took tolcapone and the average number of cigarettes/day smoked while all subjects took placebo). Then, we statistically assessed if there was a significant difference between these averages.|Days 1 through 7 of each study period|29 subjects completed both fMRI scan sessions; however, data from 9 subjects were excluded from analysis, due to either poor fMRI data quality, low task accuracy (defined as task scores falling two standard deviations below the mean), or a failure to respond to more than 30% of the task's items. Below, we report on the 20 remaining subjects.||Average number of cigarettes smoked/day||Standard Deviation|Mean
804988|NCT01001520|Secondary|Cognitive Performance: Reaction Time|"Subjects underwent two, 11-day study medication periods (one taking active tolcapone; one taking placebo). On Day 8 of each study medication period, after at least 24 hours of smoking abstinence, subjects completed an fMRI brain scan. During these fMRI scan sessions, participants completed computer tasks that were designed to test working memory and attention. These tasks were similar to computer games, in that participants would push a button in response to the pictures they see.
Specifically, we tested whether subjects, while taking tolcapone, would display increased average reaction time (in milliseconds) during the N-back working memory task compared to their performance while they took the placebo. This was a within-subject analysis."|At fMRI scan sessions - Days 8 and 29|29 subjects completed both fMRI scan sessions; however, data from 9 subjects were excluded from analysis, due to either poor fMRI data quality, low task accuracy (defined as task scores falling two standard deviations below the mean), or a failure to respond to more than 30% of the task's items. Below, we report on the 20 remaining subjects.||Milliseconds||Standard Error|Mean
804989|NCT01001520|Secondary|Cognitive Performance: Accuracy|"Subjects underwent two, 11-day study medication periods (one taking active tolcapone; one taking placebo). On Day 8 of each study medication period, after at least 24 hours of smoking abstinence, subjects completed an fMRI brain scan. During these fMRI scan sessions, participants completed computer tasks that were designed to test working memory and attention. These tasks were similar to computer games, in that participants would push a button in response to the pictures they see.
Specifically, we tested whether subjects, while taking tolcapone, would display increased accuracy during the N-back working memory task compared to their performance while they took the placebo. We measured accuracy by counting the absolute number of true positives scored (the number each subject got correct during the task). This was a within-subject analysis."|At fMRI scan sessions - Days 8 and 29|29 subjects completed both fMRI scan sessions; however, data from 9 subjects were excluded from analysis, due to either poor fMRI data quality, low task accuracy (defined as task scores falling two standard deviations below the mean), or a failure to respond to more than 30% of the task's items. Below, we report on the 20 remaining subjects.||Number of true positives||Standard Error|Mean
804990|NCT01001520|Primary|"Measure of Brain Activity: Blood Oxygen Level Dependent (BOLD) fMRI Signal Change During the N-back Working Memory Task (Brain Region: Right Dorsolateral Prefrontal Cortex; Right DLPFC)"|"Subjects completed two, 11-day study medication periods (one taking active tolcapone; one taking placebo). On Day 8 of each period, after at least 24 hours of smoking abstinence, subjects had an fMRI scan to measure changes in brain activity that occur during a memory test. The subjects completed a commonly used working memory test referred to as the N-back. This test presented complex geometric figures on a projection screen for 0.5 seconds; each figure is separated by 2.5 seconds of black screen. There were 4 conditions requiring increasing memory demands: 0-back, 1-back, 2-back, & 3-back. Subjects had to respond to the target geometric figure that was separated by 0, 1, 2, or 3 figures before it is repeated. Between each condition, there was a brief rest period.
To identify brain signal change, we calculated the difference in the amount of brain activity detected by the fMRI scan for each condition compared to the rest periods. This was a within-subject analysis."|At fMRI scan sessions - Days 8 and 29|29 subjects completed both fMRI scan sessions; however, data from 9 subjects were excluded from analysis, due to either poor fMRI data quality, low task accuracy (defined as task scores falling two standard deviations below the mean), or a failure to respond to more than 30% of the task's items. Below, we report on the 20 remaining subjects.||BOLD signal||Standard Error|Mean
804991|NCT01001546|Primary|The Impact of an Internet Intervention on Rates of Abstinence From Cigarettes (Self-reported 7-day Point Prevalent Abstinence)||3 months post treatment|||percentage of participants|||Number
804992|NCT01001559|Secondary|Absolute Count of Alterations in Therapy Required, Such as Dose Increases, Antidepressant Substitutions, or Addition of Augmentation Medications||60 days|||Alterations in antidepressant therapy|||Number
804993|NCT01001559|Secondary|Number of Hospitalizations Due to MDD|Number of hospitalizations due to MDD during treatment were assessed during this retrospective analysis of L-methylfolate plus SSRI/SNRI at treatment initiation (n=95) and SSRI/SNRI monotherapy (n-147) from patient charts|60 days|||Hospitalizations due to MDD|||Number
805045|NCT01002339|Secondary|Percentage of Patients Using Acetylsalicylic Acid (ASA)||1 year|Analysis population description: participants living with a functioning graft at study end.||percentage of participants||95% Confidence Interval|Number
804995|NCT01001559|Primary|Improvement as Measured by Change in Clinical Global Impression of Severity (CGI-S) Rating From Baseline|"The Clinical Global Impression of Severity (CGI-S) Rating evaluates the severity of individual symptoms and treatment response in patients with mental disorders. The CGI-S is a 7-point scale that that requires the clinician to rate the severity of the patient’s illness at the time of assessment. A rating of 1 is considered normal, or with the least severe symptoms, a rating of 7 is extremely ill, or the worst symptoms.
Number of patients with an improvement in CGI-S scores as demonstrated by a reduction in ≥2 points (major improvement) from baseline."|60 days|All participants||Participants|||Number
804996|NCT01001572|Secondary|Percentage of Participants With Overall Blood Pressure Control at 8 Week Endpoint|The percentage of participants with Overall Blood Pressure Control defined as the percentage of participants with a Mean Sitting Systolic Blood Pressure (MSSBP)/Mean Sitting Diastolic Blood Pressure (MSDBP) < 140/90 mmHg.|Week 8|Full Analysis Set includes all randomized participants who had both baseline and at least one post-baseline efficacy measurement.||Percentage of Participants|||Number
804997|NCT01001572|Secondary|Percentage of Participants With Diastolic Blood Pressure Control at 8 Week Endpoint|The percentage of participants with Diastolic Blood Pressure Control defined as the percentage of participants with a Mean Sitting Diastolic Blood Pressure (MSDBP) < 90 mmHg.|Week 8|Full Analysis Set includes all randomized participants who had both baseline and at least one post-baseline efficacy measurement.||Percentage of Participants|||Number
804998|NCT01001572|Secondary|Percentage of Participants With a Diastolic Blood Pressure Response at 8 Week Endpoint|The percentage of participants with a Diastolic Blood Pressure Response defined as the percentage of participants with a Mean Sitting Diastolic Blood Pressure (MSDBP) < 90 mmHg or a >= 10 mmHg reduction from baseline.|Baseline and Week 8|Full Analysis Set includes all randomized participants who had both baseline and at least one post-baseline efficacy measurement.||Percentage of Participants|||Number
804999|NCT01001572|Secondary|Change in Mean Sitting Systolic Blood Pressure (MSSBP) From Baseline to Week 8 Endpoint|Three arterial blood pressure (BP) determinations were made after the participant was in the sitting position for 5 minutes according to the American Heart Association guidelines using a calibrated standard aneroid or mercury sphygmomanometer or a calibrated standard sphygmomanometer. The change in the MSSBP was calculated comparing the Week 8 readings to the readings taken at Baseline. The change from baseline in MSSBP was analyzed using an analysis of covariance model (ANCOVA) with treatment and center (pooled as appropriate) as factors and centered baseline MSSBP as a covariate|Baseline and Week 8|Full Analysis Set includes all randomized participants who had both baseline and at least one post-baseline efficacy measurement. Last Observation Carried Forward.||mmHg||Standard Error|Least Squares Mean
805000|NCT01001572|Primary|Change in Mean Sitting Diastolic Blood Pressure (MSDBP) From Baseline to Week 8 Endpoint|Three arterial blood pressure (BP) determinations were made after the participant was in the sitting position for 5 minutes according to the American Heart Association guidelines using a calibrated standard aneroid or mercury sphygmomanometer or a calibrated standard sphygmomanometer. The change in the MSDBP was calculated comparing the Week 8 readings to the readings taken at Baseline. The change from baseline in MSDBP was analyzed using an analysis of covariance model (ANCOVA) with treatment and center (pooled as appropriate) as factors and centered baseline MSDBP as a covariate.|Baseline and Week 8|Full Analysis Set includes all randomized participants who had both baseline and at least one post-baseline efficacy measurement. Last Observation Carried Forward.||mmHg||Standard Error|Least Squares Mean
805001|NCT01001702|Secondary|Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)|The C-SSRS consisted of a baseline evaluation (completed at the first scheduled visit upon approval of protocol Amendment 3) that assessed the lifetime experience of the participant with suicide events and suicidal ideation and a post-baseline evaluation at each visit that focused on suicidality since the last trial visit. Some questions are yes/no and some are on a scale of 1 (low severity) to 5 (high severity). The number of participants experiencing suicidal ideation or suicidal behavior is reported.|Baseline, Up to 72 months|All participants with available assessment.||Participants|||Number
805002|NCT01001702|Secondary|Number of Participants Showing Significant Weight Gain or Loss|Weight was measured at Baseline, Months 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, and 72. A clinically significant weight gain was defined as a ≥ 7 % increase from Baseline. A clinically significant Weight loss was defined as a ≥ 7% decrease from Baseline.|Baseline, Up to 72 months|Participants with baseline assessment and at least one post-baseline numeric result for the given parameter.||Participants|||Number
805003|NCT01001702|Secondary|Number of Participants With Clinically Abnormal Changes in Electrocardiograms (ECGs) Evaluations|"A 12-lead ECG was recorded at Baseline, Months 6, 12, 24, 36, 48, 60 and 72. Three readings taken 5 minutes were read by a central ECG reading service and averaged.
Clinically significant ECGs were defined as:
Sinus Bradycardia: ≤ 50 beats per minute (bpm), decrease of ≥ 15 bpm from Baseline.
Supraventricular premature beat: ≥ 2 per 10 seconds, increase from Baseline. Ventricular premature beat: ≥ 1 per 10 seconds, increase from Baseline. Right bundle branch block: present. Other intraventricular block: QRS ≥ 0.10 seconds for age 13-17 years or QRS ≥ 0.11 seconds for age ≥ 18 years, an increase of ≥ 0.02 seconds from Baseline.
Symmetrical T-wave inversion: present. QTcB (QT interval corrected Bazett’s formula), QTcF (QT interval corrected Fridericia’s formula), QTcN (QT corrected FDA Neuropharmacology Division formula), QTcE (QT corrected fractional exponent correction method: ≥ 420 msec for age 13-17 years or ≥ 450 msec for age ≥ 18 years, ≥ 10 % increase from Baseline."|Baseline, Up to 72 months|Participants with at least one post-baseline numeric result for the given parameter.||Participants|||Number
805004|NCT01001702|Secondary|Number of Participants With Clinically Significant Blood Pressure|"Systolic and Diastolic blood pressure was measured at Baseline and at all visits supine (lying on the back) and standing.
Systolic increase was an increase of ≥ 20 mm Hg compared to Baseline and systolic decrease was a decrease of ≥ 20 mm Hg compared to Baseline.
A diastolic increase was an increase of ≥ 15 mm Hg compared to Baseline and a diastolic decrease was a decrease of ≥ 15 mm Hg compared to Baseline."|Baseline, Up to 72 months|Participants with baseline assessment and at least one post-baseline numeric result for the given parameter.||Participants|||Number
805046|NCT01002339|Secondary|Changes of Carotid Intima-media Thickness Over Time|absolute difference between carotid intima-media thickness at study end versus baseline.|1 year|Participants analyzed: participants living with a functioning graft at study end.||mm||95% Confidence Interval|Mean
805006|NCT01001702|Secondary|Number of Participants With Clinical Significant Laboratory Tests|"Blood was collected for Fasting clinical laboratory tests (serum chemistry and hematology) at Baseline, Months 12, 24, 36, 48, 60, and 72 and were analyzed at a central laboratory.
Clinically significant values are defined as the following:
Bilirubin, total ≥ 2.0 mg/dL. Creatine phosphokinase > 500 U/L for participants 13-17 years or 3 times the upper limit of normal for participants ≥ 18 years [Reference Range (0 to 190 IU/L (females) and 0 to 235 IU/L (males)].
Eosinophils ≥ 10 %. Hematocrit < 30 % for participants 13-17 years old or ≥ 18 year old participants female ≤ 32 % and a 3 point decrease from baseline or male ≤ 37 % and a 3 point decrease from baseline.
Hemoglobin female ≤ 9.5 g/dL or male ≤ 11.5 g/dL. Prolactin > 1 times the upper limit of normal [Reference range: 2 to 18 ng/mL (males) and 3 to 30 ng/mL (females)]."|Baseline, Up to 72 Months|Participants with at least one post-baseline numeric result for the given laboratory test are included in the analysis.||Participants|||Number
805007|NCT01001702|Secondary|Change From Baseline in Clinical Global Impression Severity of Illness (CGI-S) Score|"The rater or investigator answered the following question:
Considering your total clinical experience with this particular population, how mentally ill is the patient at this time? Response choices included: 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. A negative change from Baseline indicated improvement"|Baseline, Last Visit (Up to 72 Months)|Participants with baseline assessment and at least one post-baseline measurement for analysis.||Score on a scale||Standard Deviation|Mean
805008|NCT01001702|Primary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs and Deaths|"An AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a subject. Change in clinical relevance (severity increased) was entered as a new AE in the current trial. Abnormal laboratory test findings were considered AEs if, in the opinion of the investigator, they represented an abnormal (clinically significant) change from baseline for that individual subject.
An AE was considered serious if it was fatal; life-threatening; persistently or significantly disabling or incapacitating; required in-patient hospitalization or prolonged hospitalization; a congenital anomaly/birth defect; or other medically significant event that, based upon appropriate medical judgment, may have jeopardized the subject and may have required medical or surgical intervention.
Additional information about Adverse Events can be found in the Adverse Event section."|Up to 72 months|Safety population included all participants who received at least one dose of study drug.||Participants|||Number
805009|NCT01001767|Primary|Change in Flow Mediated Dilation (FMD) of the Brachial Artery|Flow mediated dilation (FMD) of the brachial artery measured by ultrasound is a measure of endothelium dependent endothelial cell function. FMD is expressed as a percent change from baseline brachial artery diameter to brachial artery diameter after reactive hyperemia.|baseline and week 24|Randomized to have equal number in both groups||percent change||Standard Deviation|Mean
805010|NCT01001806|Primary|Peak Aqueous Penetration||day 4 of treatment|Protocol specified enrollment of 126 subjects and analysis was performed per protocol.||ng/ml||Standard Deviation|Mean
805011|NCT01001832|Secondary|Long-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality|LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Sodium (mEq/L): <0.95*LLN or >1.05*ULN, or if preRX<LLN, use <0.95*preRX or >ULN, or if preRX>ULN, use 1.05*preRX or <LLN; potassium (mEq/L): <0.9*LLN or >1.1*ULN, or if preRX<LLN, use <0.9*preRX or >ULN, or if preRX>ULN, use 1.1*preRX or <LLN; chloride (mEq/L): <0.75*LLN or >1.125*ULN, or if preRX<LLN, use <0.75*preRX or >ULN, or if preRX>ULN, use 1.25*preRX or <LLN; calcium (mg/dL): <0.75*LLN or >1.25*ULN, or if preRX<LLN, use <0.75*preRX or >ULN, or if preRX>ULN, use 1.25*preRX or <LLN; phosphorus (mg/dL): <0.75*LLN or >1.25*ULN, or if preRX<LLN, use <0.67*preRX or >ULN, or if preRX>ULN, use 1.33*preRX or <LLN.|Baseline to Day 533|All randomized participants who received at least 1 dose of study medication.||Participants|||Number
805012|NCT01001832|Primary|Mean Change in DAS28-CRP From Baseline at Day 533 in Long Term Period|The Disease Activity Score 28 using C-Reactive Protein (DAS28-CRP) is a measure of disease activity in rheumatoid arthritis (RA) and assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), CRP level (a measure of inflammation in the blood), and the patient’s global assessment of health (ranging from very good to very bad). An overall DAS >5.1 implies active disease; <3.2, well controlled disease; and <2.6, remission.). Treatment groups represent treatment received in the short term period. Baseline is Day 1 of the study or last non-missing pre-treatment value.|Baseline to Day 533|Participants treated with at least 1 dose of study drug and who had both baseline and post-baseline measurements were analyzed.||units on a scale||95% Confidence Interval|Mean
805013|NCT01001832|Primary|Percentage of Participants With Health Assessment Questionnaire (HAQ) Response at Day 533 in Long Term Period|The Health Assessment Questionnaire (HAQ) disability index assesses patients' functional ability by rating their abilities over the previous week. At least 2 questions are asked from each of 8 categories: dressing and grooming, hygiene, arising, reach, eating, grip, walking, and common daily activities. Patients rate difficulty performing specific tasks: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The higher the number the worse the outcome. The sum of the categories score (the highest scored item in the category) is divided by the number of categories answered, yielding a score from 0-3. HAQ response=reduction of at least 0.30 units in HAQ score from baseline. The percentage of participants with a reduction of at least 0.30 units in their HAQ score from baseline is presented. Baseline is Day 1 of the study or last non-missing pre-treatment value. Treatment groups represent treatment received in the short term period.|Day 533|N=number of participants treated with at least 1 dose of study drug and with HAQ data available. n=number of participants with HAQ response. n/N = 41/52 and 31/51 in SC and IV arms, respectively. Treatment groups represent treatment received in the short term period.||percentage of participants||95% Confidence Interval|Number
805047|NCT01002339|Secondary|Percentage of Patients Using Statins||1 year|Participants analyzed: participants living with a functioning graft at study end.||percentage of participants||95% Confidence Interval|Number
805048|NCT01002339|Secondary|Lipidic Profile (LDL-c)||1 year|Participants analyzed: participants living with a functioning graft at study end.||mg/dl||Standard Deviation|Mean
805049|NCT01002339|Secondary|Lipidic Profile (HDL-c)||1 year|Participants analyzed: participants living with a functioning graft at study end.||mg/dl||Standard Deviation|Mean
805050|NCT01002339|Secondary|Lipidic Profile (Cholesterol)|Lipidic Profile (total cholesterol)|1 year|Participants analyzed: participants living with a functioning graft at study end.||mg/dl||Standard Deviation|Mean
805014|NCT01001832|Primary|Mean Change From Baseline in HAQ-DI Score at Day 533 in Long Term Period|Adjusted mean. The Health Assessment Questionnaire Disability Index (HAQ-DI) assesses patients' functional ability by rating their abilities over the previous week. At least 2 questions are asked from each of 8 categories: dressing and grooming, hygiene, arising, reach, eating, grip, walking, and common daily activities. Patients rate difficulty performing specific tasks: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The sum of the categories score (the highest scored item in the category) is divided by the number of categories answered, yielding a score from 0-3. Treatment groups represent treatment received in the short term period. Baseline is Day 1 of the study or last non-missing pre-treatment value.|Baseline to Day 533|Number of participants with both baseline and post-baseline measurements in HAQ-DI. Treatment groups represent treatment received in the short term period.||units on a scale||95% Confidence Interval|Mean
805015|NCT01001832|Primary|Percentage of Participants With Sustained American College of Rheumatology (ACR) Response at Day 533 in Long Term Period - All Randomized and Treated Participants During the Long Term Period|The ACR score indicates the degree of improvement in a patient's rheumatoid arthritis (RA), based on ACR guidelines. The ACR score= a percentage. To qualify for a score of 20, 50 or 70 (ACR20, ACR50 or ACR70), the patient must have >=20%, >=50% or >=70%, respectively, fewer tender joints and >=20%, >=50% or >=70%, respectively, fewer swollen joints and show 20%, 50% or 70%, respectively, improvement in at least 3 of the following: patient overall assessment of his/her RA, physician global assessment of the patient’s RA, patient self-assessment of pain, patient self-assessment of physical functioning, and results of an erythrocyte sedimentation rate or C-reactive protein test (to assess inflammation). Treatment groups represent treatment received in the short term period. Percentage calculated as n/m with n=number of paticipants with sustained ACR response at Day 533; m= long term participants who received at least one dose of drug and were ACR responders in the short term period.|Day 533|m=Long term period participants who received at least one dose of drug and were ACR responders in short term period: ACR20= 49, 46; ACR50= 35, 34; ACR70= 20, 16. n=number of paticipants with sustained ACR response at Day 533. n/m = percentage||percentage of participants||95% Confidence Interval|Number
805016|NCT01001832|Secondary|Long-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality|ULN=upper limit of normal; LLN=lower limit of normal; preRX=pretreatment. ALP (U/L): >2*ULN, or if preRX>ULN, use >3*preRX; AST (U/L): >3*ULN, or if preRX>ULN, use >4*preRX; ALT (U/L): >3*ULN, or if preRX>ULN, use >4*preRX; GGT (U/L): >2*ULN, or if preRX>ULN, use >3*preRX; bilirubin (mg/dL): >2*ULN, or if preRX>ULN, use >4*preRX; blood urea nitrogen (mg/dL): >2*preRX; creatinine (mg/dL): >1.5*preRX.|Baseline to Day 533|All randomized participants who received at least 1 dose of study medication.||Participants|||Number
805017|NCT01001832|Secondary|Short-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality|LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Sodium (mEq/L): <0.95*LLN or >1.05*ULN, or if preRX<LLN, use <0.95*preRX or >ULN, or if preRX>ULN, use 1.05*preRX or <LLN; potassium (mEq/L): <0.9*LLN or >1.1*ULN, or if preRX<LLN, use <0.9*preRX or >ULN, or if preRX>ULN, use 1.1*preRX or <LLN; chloride (mEq/L): <0.75*LLN or >1.125*ULN, or if preRX<LLN, use <0.75*preRX or >ULN, or if preRX>ULN, use 1.25*preRX or <LLN; calcium (mg/dL): <0.75*LLN or >1.25*ULN, or if preRX<LLN, use <0.75*preRX or >ULN, or if preRX>ULN, use 1.25*preRX or <LLN; phosphorus (mg/dL): <0.75*LLN or >1.25*ULN, or if preRX<LLN, use <0.67*preRX or >ULN, or if preRX>ULN, use 1.33*preRX or <LLN.|Baseline to Day 169|All randomized participants who received at least 1 dose of study medication.||Participants|||Number
805018|NCT01001832|Secondary|Short-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality|ULN=upper limit of normal; LLN=lower limit of normal; preRX=pretreatment. alkaline phosphatase (ALP) (U/L): >2*ULN, or if preRX>ULN, use >3*preRX; aspartate aminotransferase (AST) (U/L): >3*ULN, or if preRX>ULN, use >4*preRX; alanine aminotransferase(ALT) (U/L): >3*ULN, or if preRX>ULN, use >4*preRX; Gamma glutamyltransferase(GGT) (U/L): >2*ULN, or if preRX>ULN, use >3*preRX; bilirubin (mg/dL): >2*ULN, or if preRX>ULN, use >4*preRX; blood urea nitrogen (mg/dL): >2*preRX; creatinine (mg/dL): >1.5*preRX.|Baseline to Day 169|All randomized participants who received at least 1 dose of study medication.||Participants|||Number
805019|NCT01001832|Secondary|Long-term Period: Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria|LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Hemoglobin (g/dL): >3 g/dL decrease from preRX; hematocrit (%): <0.75*preRX; erythrocytes (*10^6 c/uL): <0.75*preRX; platelet count (*10^9 c/uL): <0.67*LLN or >1.5*ULN, of if preRX<LLN, use 0.5*preRX and <100,000/mm^3; leukocytes (*10^3 c/uL): <0.75*LLN or >1.25*ULN, or if preRX <LLN, use <0.8*preRX or >ULN, or if preRX>ULN, use >1.2*preRX or <LLN; neutrophils+bands (*10^3 c/uL): if value <1.0*10^3 c/uL; eosinophils (*10^3 c/uL): if value >0.750*10^3 c/uL; basophils (*10^3 c/uL): if value >400/mm^3; monocytes (*10^3 c/uL): if value >2000/mm^3; lymphocytes (*10^3 c/uL): if value <0.750*10^3 c/uL or if value >7.50*10^3 c/uL.|Baseline to Day 533|All randomized participants who received at least 1 dose of study medication.||Participants|||Number
805020|NCT01001832|Secondary|Short-term Period: Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality|lower limit of normal(LLN); upper limit of normal(ULN); pretreatment(preRX). Hemoglobin (g/dL): >3 g/dL decrease from preRX; hematocrit (%): <0.75*preRX; erythrocytes (*10^6 c/uL): <0.75*preRX; platelet count (*10^9 c/uL): <0.67*LLN or >1.5*ULN, of if preRX<LLN, use 0.5*preRX and <100,000/mm^3; leukocytes (*10^3 c/uL): <0.75*LLN or >1.25*ULN, or if preRX <LLN, use <0.8*preRX or >ULN, or if preRX>ULN, use >1.2*preRX or <LLN; neutrophils+bands (*10^3 c/uL): if value <1.0*10^3 c/uL; eosinophils (*10^3 c/uL): if value >0.750*10^3 c/uL; basophils (*10^3 c/uL): if value >400/mm^3; monocytes (*10^3 c/uL): if value >2000/mm^3; lymphocytes (*10^3 c/uL): if value <0.750*10^3 c/uL or if value >7.50*10^3 c/uL.|Baseline to Day 169|All randomized participants who received at least 1 dose of study medication.||Participants|||Number
805042|NCT01002287|Secondary|Adhesion Involvement Along the Midline Incision (Percentage)|The proportion of the total length of the initial midline incision associated with any adhesion at the time of the follow-up surgery, as determined by dividing the length of the incision associated with adhesions (cm) by the overall initial midline incision length (cm). This calculates the extent of adhesion involvement as a percentage.|average 10-12 weeks post surgery|These patients must have values for length of the incision associated with adhesions (cm) and for length of initial midline incision (cm) in order to calculate Extent of Adhesion Involvement (%). NOTE: Extent of Adhesion Involvement (%) = length of the incision associated with adhesions (cm) / length of initial midline incision (cm) * 100.||percentage of midline incision||Standard Deviation|Mean
805021|NCT01001832|Secondary|Long-term Period: Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=related or missing relationship to study medication.|Baseline to Day 533 and up to 56 days following last dose in Long-Term period|All randomized participants who received at least 1 dose of study medication.||Participants|||Number
805022|NCT01001832|Secondary|Short-term Period: Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=related or missing relationship to study medication.|Baseline to Day 169|All randomized participants who received at least 1 dose of study medication.||Participants|||Number
805023|NCT01001832|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR)-Defined Low Disease Activity Score (LDAS) and EULAR-defined Remission (REM) at Day 533 in Long Term Period|EULAR defines LDAS as DAS28-CRP≤3.2 and defines REM as DAS28-CRP<2.6.|Day 533|m=All treated participants in the long term period in the analysis with available LDAS and REM data. n=number of participants with either EULAR-defined LDAS response or EULAR-defined REM response. n/m = percentage of participants||percentage of participants||95% Confidence Interval|Number
805024|NCT01001832|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR)-Defined Low Disease Activity Score (LDAS) and EULAR-defined Remission (REM) at Day 169 in Short Term Period|EULAR defines LDAS as DAS28-CRP less than, equal to (≤) 3.2 and defines REM as DAS28-CRP less than (<) 2.6.|Day 169|m=All randomized participants who received at least 1 dose of study medication and with LDAS and REM data available. n= number of participants with LDAS and REM. n/m=percentage of participants.||Percentage of participants||95% Confidence Interval|Number
805025|NCT01001832|Secondary|Mean Change From Baseline at Six Months in DAS28-CRP - All Treated Participants|The Disease Activity Score 28 using C-Reactive Protein (DAS28-CRP) is a measure of disease activity in rheumatoid arthritis (RA) and assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), CRP level (a measure of inflammation in the blood), and the patient’s global assessment of health (ranging from very good to very bad). An overall DAS >5.1 implies active disease; <3.2, well controlled disease; and <2.6, remission.). Baseline is Day 1 or last non-missing pre-treatment value.|Baseline to 6 Months|All participants who received at least 1 dose of study medication with both baseline and post-baseline measurements were analyzed.||Units on a scale||95% Confidence Interval|Mean
805026|NCT01001832|Secondary|Percentage of Participants With HAQ Response at Day 169 in the Short Term Period|The Health Assessment Questionnaire Disability Index (HAQ-DI) assesses patients' functional ability by rating their abilities over the previous week. At least 2 questions are asked from each of 8 categories: dressing and grooming, hygiene, arising, reach, eating, grip, walking, and common daily activities. Patients rate difficulty performing specific tasks: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The sum of the categories score (the highest scored item in the category) is divided by the number of categories answered, yielding a score from 0-3. The HAQ-DI response is defined as a reduction of at least 0.30 units in HAQ score from baseline.|Day 169|N=All randomized participants who received at least 1 dose of study medication in short term period. n=number of participants with HAQ response in short term period; n/N=percentage of participants: 41/59 and 30/59||Percentage of participants||95% Confidence Interval|Number
805027|NCT01001832|Secondary|Mean Change From Baseline in HAQ-DI Score at Day 169 in Short Term Period|Adjusted mean. The Health Assessment Questionnaire Disability Index (HAQ-DI) assesses patients' functional ability by rating their abilities over the previous week. At least 2 questions are asked from each of 8 categories: dressing and grooming, hygiene, arising, reach, eating, grip, walking, and common daily activities. Patients rate difficulty performing specific tasks: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The sum of the categories score (the highest scored item in the category) is divided by the number of categories answered, yielding a score from 0-3.|Baseline to Day 169|All participants who received at least 1 dose of study medication were analyzed.||Units on a scale||95% Confidence Interval|Mean
805028|NCT01001832|Secondary|Percentage of Participants With American College of Rheumatology 50 (ACR50) and American College of Rheumatology 70 (ACR70) Responses at Day 169 in Short Term Period|The American College of Rheumatology (ACR) scores of 50 and 70 indicates the degree of improvement in a patient's rheumatoid arthritis (RA), based on ACR guidelines. The ACR score represents a percentage. To qualify for an ACR50 or ACR70 scores, the patient must have >=50% or >=70%, respectively, fewer tender joints and >=50% or >=70%, respectively, fewer swollen joints and show 50% or 70%, respectively, improvement in at least 3 of the following: patient overall assessment of his/her RA, physician global assessment of the patient’s RA, patient self-assessment of pain, patient self-assessment of physical functioning, and results of an erythrocyte sedimentation rate or C-reactive protein test (to assess inflammation).|Day 169|m= All participants who received at least 1 dose of study medication in short term period and had data available. n= participants with ACR50 or ACR70 response in the short term period. n/m= percentage||Percentage of participants||95% Confidence Interval|Number
805043|NCT01002287|Secondary|Severity of Adhesions|Worst midline adhesion severity score. The severity of adhesions was categorized as filmy thickness, avascular; moderate thickness, limited vascularity; and dense thickness, vascularised. The corresponding numeric severity ratings are “1”, “2”, and “3”. Subjects without adhesions were assigned a severity rating of “0”.|Average 10-12 weeks post surgery|All 11 subjects met the definition of per protocol population in the protocol and statistical analysis plan.||units on a scale||Standard Deviation|Mean
805051|NCT01002339|Secondary|Lipidic Profile (Triglycerides)||1 year|Participants analyzed: participants living with a functioning graft at study end.||mg/dl||Standard Deviation|Mean
805029|NCT01001832|Primary|Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Day 169 in Short Term Period|The ACR score of 20 indicates the degree of improvement in a patient's rheumatoid arthritis (RA), based on ACR guidelines (ACR20). The ACR score represents a percentage. To qualify for an ACR20 score, the patient must have >=20% fewer tender joints and >=20% fewer swollen joints and show 20% improvement in at least 3 of: patient overall assessment of his/her RA, physician global assessment of the patient’s RA, patient self-assessment of pain, patient self-assessment of physical functioning, and results of an erythrocyte sedimentation rate or C-reactive protein test (to assess inflammation). Percentage is calculated n/N with n=number of participants with ACR score of 20 and N= all randomized participants who received at least one dose of study drug.|Day 169|N= All randomized participants who received at least 1 dose of study medication and were analyzed. n=number of participants with ACR20 response at Day 169: 54, 49, respectively. n/N= percentage: 54/59; 49/59.||Percentage of participants||95% Confidence Interval|Number
805032|NCT01002105|Secondary|Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)|"Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) is a self-report form composed of 16 items, each rated on a 5-point scale that indicates the degree of enjoyment or satisfaction with: physical health; social relations; ability to function in daily life; ability to get around physically; mood; family relations; sexual drive and interest; ability to work on hobbies, work, leisure time activities; economic status; household activities; and living/housing situation. A total score of 1 to 15 items was computed while item 16 assessing overall life satisfaction was not included to avoid exaggerated scores. The total score was averaged from items 1 to 15 and ranged from 1 to 5, with higher scores indicating higher satisfaction."|baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks|||units on a scale||Standard Deviation|Mean
805033|NCT01002105|Secondary|Multidimensional Scale of Perceived Social Support|The MSPSS is a self-report instrument for assessment of emotional help and the level of satisfaction with the social support obtained from three sources - family, friends and significant others. The scale includes 12 items, each of which refer to the people to whom the respondent would turn if he/she had problems of a personal, health or family nature, as well as financial and employment problems. Responses are scored on a 7-point scale from 1 ('completely disagree') to 7 ('completely agree'). The MSPSS index and three subscales – family, friends and significant others - are computed. MSPSS total score ranged from 12 to 84, with a higher score indicating greater satisfaction with total support. Subscores ranged from 4 to 28, with higher score indicating greater satisfaction.|Baseline, 52 weeks|||units on a scale||Standard Deviation|Mean
805034|NCT01002105|Secondary|General Self-Efficacy Scale|"The GSES measures one’s belief in his/her ability to cope with stressful situations. The scale consists of 10 items (e.g. Usually I am able to control a situation or In unexpected situations, I always know how I must behave myself). Responses are rated on a 4- point Likert-scale ranging from ”absolutely not true” (weighted as 1) to “absolutely true” (weighted as 4), where the higher GSES total scores indicate stronger self-efficacy beliefs.All responses are added to a sum score. The range is from 10 to 40 points with a higher score indicating more self-efficiency."|baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks|||units on a scale||Standard Deviation|Mean
805035|NCT01002105|Secondary|General Health Questionnaire|The General Health Questionnaire measures whether the respondent has recently experienced a particular symptom or behavior and ranges from 0-much less than usual to 3-much more than usual. Total scores range from 0 to 36 and vary by study population: total scores of about 11-12 are typical, and a score higher than 20 suggests severe problems and psychological distress.|baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks|||units on a scale||Standard Deviation|Mean
805036|NCT01002105|Secondary|Obsessive-Compulsive Drinking Scale Scores|Used to evaluate self-reported alcohol craving. 14 items that provided a total (OCDS) as well as two subscale scores - obsessive drinking (OD) and compulsive drinking (CD). Each of the 14 items are scored from 0 to 4 with the inclusion of 4 split items with only the higher of the two scored items to be used in the total or subscale scores. The OCDS total score ranges from 0-40; the subscales both range from 0 to 20. On all scales, higher scores represent a worse outcome. Data for CD at 6 weeks not available to report|baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks|||units on a scale||Standard Deviation|Mean
805037|NCT01002105|Primary|Percent Abstinent Days|Percent abstinent days at 52 weeks. % of abstinent days were assessed by (1) patient's self-evaluation; (2) family member interview; (3) calculation of cumulative abstinence duration (CAD), defined as the total number of days of abstinence, Abstinent days was calculated for each Arm as a whole.|one year|||percentage of abstinent days|||Number
805038|NCT01002118|Secondary|Medication Adherence|percent of pills taken each month calculated as number of pills taken/number of pills dispensed|4 months|||percentage of pills|||Number
805039|NCT01002118|Secondary|Assess the Effectiveness of Omega-3 Fatty Acid Compared to Placebo on Electrocardiographic Parameters.|percent of subjects with significant arrhythmia present on Holter electrocardiography|4 months|||percentage of Holter montiors obtained|||Number
805040|NCT01002118|Primary|Determine Recruitment Rates|Determine recruitment by number eligible/number enrolled|4 months|||Participants|||Count of Participants
805052|NCT01002339|Secondary|Number of Antihypertensive Drugs Patients Reported Taking.||1 year|Participants analyzed: participants living with a functioning graft at study end.||number of antihypertensive drugs||Inter-Quartile Range|Median
805058|NCT01002339|Primary|Primary Outcome Measure (Glucose Intolerance)|Glycemia >=140 and <200 mg/dl, 2 hours after a standard oral glucose tolerance test. Measured values: glucose intolerance at 1 year defined by ADA criteria.|1 year|Participants included are those that did not develop NODAT based on not reporting the use of anti-diabetic drugs plus a fasting plasma glucose <126 mg/dl .||percentage of participants||95% Confidence Interval|Number
805059|NCT01002339|Primary|Patients Treated With Insulin or Oral Antidiabetic Drugs||1 year|Participant analyzed: participants living with a functioning graft at study end.||percentage of participants||95% Confidence Interval|Number
805060|NCT01002339|Primary|"Primary Outcome Measure New Onset Diabetes After Renal Transplantation (NODAT)"|American Diabetes Association criteria (ADA) including an oral glucose tolerance test.|1 year|Participants analyzed: participants living with a functioning graft at study end||percentage of participants||95% Confidence Interval|Number
805061|NCT01002456|Secondary|Progress Toward Adherence to Guideline Prescription|either change to a guideline agent or dose increase of a guideline agent|6 months|||patients|||Number
805062|NCT01002456|Primary|Rate of Adherence to Guideline Prescription|full adherence to guideline medication and dose|6 months|||patients|||Number
805063|NCT01002482|Secondary|Incidence of Nosocomial Bacteriemia||Date of discharge from the ICU||||||
805064|NCT01002482|Secondary|Intensive Care Unit Length of Stay||Date of discharge from the ICU|||days||Inter-Quartile Range|Median
805065|NCT01002482|Secondary|Hospital Length of Stay||Date of discharge from the hospital|||days||Inter-Quartile Range|Median
805066|NCT01002482|Secondary|Severe Hypoglycemia|Number of patients with severe biological hypoglycemia (defined as blood glucose of 40 mg per deciliter or less)regardless of clinical signs|Date of discharge from the ICU|||participants|||Number
805067|NCT01002482|Secondary|Time Spent in Blood Glucose Target||Day of discharge from the ICU||||||
805068|NCT01002482|Secondary|Intensive Care Unit Free Days|Intensive care unit free days was 28-day-ICU-free-days i.e. was calculated by subtracting the actual ICU duration in days from 28 with patients who died at day 28 or before being assigned 0 free-days and those who had a stay in ICU of 28 days or more being also assigned 0 free-days|28 days|||days||Inter-Quartile Range|Median
805069|NCT01002482|Secondary|All-cause In-hospital Mortality||Day of discharge from the hospital|||participants|||Number
805070|NCT01002482|Secondary|All-cause Intensive Care Unit Mortality||Date of discharge from the ICU|||participants|||Number
805071|NCT01002482|Secondary|All-cause 28-day Mortality||Day 28|||participants|||Number
805072|NCT01002482|Primary|All-cause 90-day Mortality||Day 90|||participants|||Number
805073|NCT01002573|Secondary|Number of Afebrile and Febrile Subject at 4 Hours Post-Dose|Number of Afebrile and Febrile Subject at 4 Hours Following Treatment|4 Hours Post-Dose|Some participants data was not included in the analysis due to having too few/insufficient data||participants|||Number
805074|NCT01002573|Secondary|Time to Afebrility (in Hours)|Tme to afebrility (temperature less than 100.4 ºF [38 ºC]) in patients receiving intravenous ibuprofen and APAP.|4 Hour post treatment|||Hours||Standard Deviation|Mean
805075|NCT01002573|Secondary|Change From Baseline in Temperature After the First Four Hours of Treatment|Change in temperature during the first 4 hours of treatment by assessing the area under the change in temperature versus time curve during the first four hours of treatment (AUC0-4)|0 to 4 hours post-dose|Some participants data was not included in the analysis due to having too few/insufficient data||degree Celsius*Time||Standard Deviation|Mean
805076|NCT01002573|Secondary|Change in Temperature|Change in temperature in patients receiving intravenous ibuprofen and APAP after the first 4 hours of treatment.|4 hours following treatment|Some participants data was not included in the analysis due to having too few/insufficient data||Celsius||Standard Deviation|Mean
805077|NCT01002573|Secondary|Change From Baseline in Temperature After the First 60 Minutes of Treatment|Change in temperature in patients receiving intravenous ibuprofen and APAP after the first 60 minutes of treatment.|60 minutes following treatment|Some participants data was not included in the analysis due to having too few/insufficient data||Celsius||Standard Deviation|Mean
805078|NCT01002573|Secondary|Change From Baseline in Temperature After the First 30 Minutes of Treatment|Change in temperature in patients receiving intravenous ibuprofen and acetaminophen (APAP) after the first 30 minutes of treatment.|30 minutes following treatment|Some participants data was not included in the analysis due to having too few/insufficient data||Celsius||Standard Deviation|Mean
805079|NCT01002573|Primary|Fever Reduction|Treatment of fever as measured by the area under the change in temperature versus time curve during the first two hours of treatment (AUC0-2)|0 to 2 hours post-dose|Some participants data was not included in the analysis due to having too few/insufficient data||degree Celsius*Time||Standard Deviation|Mean
805097|NCT01002989|Secondary|Agreement Between the Two Methods in Peripheral Artery Disease (PAD) Diagnosis|This outcome measure represents what percentage of the patients diagnosed with PAD using Doppler ABI method (reference method) were diagnosed with PAD using WatchBP Office ABI method. It also represents in what percentage of the patients in whom PAD was excluded with Doppler ABI method (reference method), PAD was excluded using WatchBP Office ABI method as well.|Once (cross-sectional)|||Percentage of participants|||Number
805098|NCT01002989|Primary|Watch BP Office Minus Doppler Ankle-Brachial Index Difference|The validation process consisted of two parts: (i) measurement validation, which compared Doppler and Watch BP Office ABI values and assessed their association, and (ii) clinical validation, which compared the diagnosis of peripheral artery disease (PAD) by the two methods and assessed the association of Watch BP Office and Doppler ABI values with cardiovascular risk factors.|once (cross-sectional)|Patients with various cardiovascular risk factors attending a hypertension or a diabetes outpatient clinic were invited to participate in the study. Subjects with atrial fibrillation or incompressible ankle arteries (ABI ≥1.4) were excluded.||ratio||Standard Deviation|Mean
805099|NCT01003067|Secondary|Feasibility of Mesh-implementation Even After Colorectal Surgery, Find Risk Factors for Wound Infection and Incisional Hernia.|Secondary endpoints are the feasibility, the safety of the mesh stripe implantation including postoperative pain, and the incidence of incisional hernias at 5 years.|5 Years||06/2020||||
805100|NCT01003067|Primary|Number of Participants With Incisional Hernia At 2 Years Following Median Laparotomy|Primary endpoint was the incidence of incisional hernias at 2 years following midline laparotomy.|2 years|||participants|||Number
805101|NCT00994604|Secondary|Changes in Airway Size by Computed Tomography|Changes in size airways as measured by computed tomography|baseline and after two weeks|||size in mm^2||Standard Deviation|Mean
805102|NCT00994604|Primary|The Primary Outcome is the Change in Bronchodilation and Bronchoprotection After Broccoli Sprout Extract|"Bronchodilator index = (1- ((1 - ((forced expiratory volume in 1 second after Methacholine A and after Deep Inspiration )÷( forced expiratory volume in 1 second baseline)))÷ (1 - ((forced expiratory volume in 1 second after Methacholine)÷( forced expiratory volume in 1 second baseline)))))x100
Bronchoprotection index = (1- ((1 - ((forced expiratory volume in 1 second after Deep Inspirations and after Methacholine B )÷( forced expiratory volume in 1 second baseline B)))÷(1 - ((forced expiratory volume in 1 second after Methacholine A)÷( forced expiratory volume in 1 second baseline A))))) x 100"|baseline and two weeks|||index||Standard Deviation|Mean
805103|NCT00994643|Primary|Assess the Efficacy of Combination Immunotherapy With Rituximab and Interleukin-2 in Patients With Non-Hodgkin's Lymphoma|Patients were enrolled based on having obtained complete remission or at least a partial remission. Efficacy was therefore determined by the number of patients that remained in remission following treatment.|1 year|||Participants|||Count of Participants
805104|NCT00994682|Secondary|Bone Mineral Density|Bone mineral density measured at the levels of spine, femoral neck, hip, and wrist by DXA.|18 and 36 months|Data analysis included 78 patients at month 18 and 62 at month 36 (based on DXA availability).||g/cm^2||Standard Deviation|Mean
805105|NCT00994682|Secondary|Molecular Pathways of Liver Glucose and Lipid Signaling; Inflammatory Pathways; Oxidative Stress; Other.||At 18 (2nd liver biopsy) and 36 (3rd liver biopsy) months.||||||
805106|NCT00994682|Secondary|Osteoporotic Fractures|Number of patients with osteoporotic fractures|18 and 36 months|||Participants|||Count of Participants
805107|NCT00994682|Secondary|Prevention of the Onset of T2DM and/or Reversal From IFG/IGT to NGT in Non-diabetics.|Number of patients developing T2DM and number of patients regressing to NGT among patients with prediabetes (IFG/IGT).|18 months|Only patients with prediabetes are included in this analysis||Participants|||Count of Participants
805108|NCT00994682|Secondary|Plasma Biomarkers Relevant to Hepatic Inflammation, Apoptosis and Fibrosis (CK-18).||18 and 36 months|Data include 101 observations at baseline (51 in the placebo group and 50 in the pioglitazone group), 83 at month 18 (42 and 41, respectively), and 63 at month 36 (29 and 34, respectively).||U/L||95% Confidence Interval|Mean
805109|NCT00994682|Secondary|Plasma Biomarkers Relevant to Hepatic Inflammation, Apoptosis and Fibrosis (Adiponectin).||18 and 36 months|Data include 101 observations at baseline (51 in the placebo group and 50 in the pioglitazone group), 83 at month 18 (42 and 41, respectively), and 63 at month 36 (29 and 34, respectively).||μg/ml||95% Confidence Interval|Mean
805110|NCT00994682|Secondary|Total Body Fat|Total body fat measured by dual-energy x-ray absorptiometry (DXA)|Months 18|Data include 101 observations at baseline (51 in the placebo group and 50 in the pioglitazone group), 83 at month 18 (42 and 41, respectively).||Percentage of body weight that is fat||Standard Deviation|Mean
805111|NCT00994682|Secondary|Body Mass Index (BMI)||Months 18 and 36|Data include 101 observations at baseline (51 in the placebo group and 50 in the pioglitazone group), 83 at month 18 (42 and 41, respectively), and 63 at month 36 (29 and 34, respectively).||kg/m^2||Standard Deviation|Mean
805112|NCT00994682|Secondary|Skeletal Muscle Insulin Sensitivity|Rate of glucose disappearance (Rd) during high-dose insulin infusion. The rate of plasma glucose disappearance was calculated using Steele’s non-steady-state equation.|18 months|Data include 101 observations at baseline (51 in the placebo group and 50 in the pioglitazone group) and 83 at month 18 (42 and 41, respectively).||mg/kgLBM/min||95% Confidence Interval|Mean
805113|NCT00994682|Secondary|Adipose Tissue Insulin Sensitivity|Suppression of free fatty acids by low dose insulin (i.e., percentage of reduction of plasma FFA with low dose insulin infusion compared to the baseline state). This was calculated as: 100*((plasma FFA without insulin - plasma FFA with insulin infusion)/plasma FFA without insulin). All measurements are obtained at the same time point during an euglycemic insulin clamp.|18 months|Data include 101 observations at baseline (51 in the placebo group and 50 in the pioglitazone group) and 83 at month 18 (42 and 41, respectively).||% of suppression of FFA||95% Confidence Interval|Mean
805114|NCT00994682|Secondary|Hepatic Insulin Sensitivity|Suppression of endogenous glucose production (Supp EGP) by low dose insulin (i.e., percentage of reduction of EGP with low dose insulin infusion compared to the baseline state). This was calculated as: 100*((EGP without insulin - EGP with insulin infusion)/EGP without insulin). All measurements are obtained at the same time point during an euglycemic insulin clamp.|18 months|Data include 101 observations at baseline (51 in the placebo group and 50 in the pioglitazone group) and 83 at month 18 (42 and 41, respectively).||% of suppression of EGP||95% Confidence Interval|Mean
810713|NCT01048606|Secondary|Dietary Intakes: 3-days Food Record. Dietary Analyses Will be Completed Using the Nutifiq Software (Université Laval)||0, 6 and 12 months||||||
805115|NCT00994682|Secondary|Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)|Homeostatic model assessment of insulin resistance (HOMA-IR) is a method for assessing insulin resistance (IR) from basal fasting plasma glucose (FPG) and fasting plasma insulin (FPI). It is calculated as (FPG x FPI)/405.|18 and 36 months|Data include 101 observations at baseline (51 in the placebo group and 50 in the pioglitazone group), 83 at month 18 (42 and 41, respectively), and 63 at month 36 (29 and 34, respectively).||Arbitrary units||95% Confidence Interval|Mean
805116|NCT00994682|Secondary|Liver Fat by Magnetic Resonance and Spectroscopy (MRS).|Liver fat content was calculated as the fat fraction: 100*(area under the curve [AUC] of fat peak / [AUC of fat peak + AUC of water peak]).|18 months|Data include 101 observations at baseline (51 in the placebo group and 50 in the pioglitazone group) and 83 at month 18 (42 and 41, respectively).||percentage of fat in liver||Standard Deviation|Mean
805117|NCT00994682|Secondary|Liver Transaminases (AST and ALT).||18 and 36 months|Data include 101 observations at baseline (51 in the placebo group and 50 in the pioglitazone group), 83 at month 18 (42 and 41, respectively), and 63 at month 36 (29 and 34, respectively).||U/L||Standard Deviation|Mean
805118|NCT00994682|Secondary|Mean Individual Histological Scores|Steatosis: 0 = <5%; 1 = 5-33%; 2 = >33-66%; 3 = >66%. Lobular Inflammation: 0 = No foci 1 = <2 foci/200x; 2 = 2-4 foci/200x, 3 = >4 foci/200x. Hepatocyte Ballooning: 0 = None; 1 = Few balloon cells; 2 = Many cells/prominent ballooning. Fibrosis: 0 = None; 1 = Perisinusoidal or periportal; 2 = Perisinusoidal and portal/periportal; 3 = Bridging fibrosis, 4 = Cirrhosis|Month 36|||units on a scale||95% Confidence Interval|Mean
805119|NCT00994682|Secondary|Individual Histological Scores|"Number of patients with improvement of at least 1 grade in each of the histological parameters.
Steatosis: 0 = <5%; 1 = 5-33%; 2 = >33-66%; 3 = >66%. Lobular Inflammation: 0 = No foci 1 = <2 foci/200x; 2 = 2-4 foci/200x, 3 = >4 foci/200x. Hepatocyte Ballooning: 0 = None; 1 = Few balloon cells; 2 = Many cells/prominent ballooning. Fibrosis: 0 = None; 1 = Perisinusoidal or periportal, 1A = Mild, zone 3, perisinusoidal delicate fibrosis; 1B = Moderate, zone 3, perisinusoidal dense fibrosis; 1C = Portal/periportal; 2 = Perisinusoidal and portal/periportal; 3 = Bridging fibrosis, 4 = Cirrhosis"|Month 18|Multiple imputation was used to impute missing histologic data for patients who did not complete 18 months of therapy.||Participants|||Count of Participants
805120|NCT00994682|Secondary|Mean Individual Histological Scores|Mean change in individual scores compared to baseline. Steatosis: 0 = <5%; 1 = 5-33%; 2 = >33-66%; 3 = >66%. Lobular Inflammation: 0 = No foci 1 = <2 foci/200x; 2 = 2-4 foci/200x, 3 = >4 foci/200x. Hepatocyte Ballooning: 0 = None; 1 = Few balloon cells; 2 = Many cells/prominent ballooning. Fibrosis: 0 = None; 1 = Perisinusoidal or periportal; 2 = Perisinusoidal and portal/periportal; 3 = Bridging fibrosis, 4 = Cirrhosis|Baseline and Month 18|Multiple imputation was used to impute missing histologic data for patients who did not complete 18 months of therapy.||units on a scale||95% Confidence Interval|Mean
805121|NCT00994682|Secondary|Number of Participants With Resolution of NASH|Resolution of NASH was defined as absence of NASH after 18 months of therapy in patients with definite NASH (presence of zone 3 accentuation of macrovesicular steatosis of any grade, hepatocellular ballooning of any degree, and lobular inflammatory infiltrates of any amount) at baseline.|Month 18|Multiple imputation was used to impute missing histologic data for patients who did not complete 18 months of therapy.||Participants|||Count of Participants
805122|NCT00994682|Primary|Liver Histology (Using Kleiner et al Criteria, Hepatology 2005)|"Number of patients with reduction of at least 2 points in the nonalcoholic fatty liver disease activity score (NAS) (with reduction in at least 2 different histological categories) without worsening of fibrosis. NAS is the sum of the separate scores for steatosis (0–3), hepatocellular ballooning (0–2) and lobular inflammation (0–3), and ranges from 0-8 .
The scoring system is based on the following grading:
Steatosis: 0 = <5%; 1 = 5-33%; 2 = >33-66%; 3 = >66%. Lobular Inflammation: 0 = No foci 1 = <2 foci/200x; 2 = 2-4 foci/200x, 3 = >4 foci/200x. Hepatocyte Ballooning: 0 = None; 1 = Few balloon cells; 2 = Many cells/prominent ballooning. Fibrosis: 0 = None; 1 = Perisinusoidal or periportal; 2 = Perisinusoidal and portal/periportal; 3 = Bridging fibrosis, 4 = Cirrhosis."|At 18 months|||Participants|||Count of Participants
805123|NCT00994760|Secondary|Caregiver: To What Extent the Treatment Needs of Your Patient Has Changed by the Use of Instanyl Regarding ...|Scale: -3= very much less, -2= much less, -1= less, 0=comparable, 1= more, 2= much more, 3= very much more|after therapy with Instanyl (last visit)|"Patients included and treated with caregiver documentation (without imputation of missing values), ITT.
All patients with valid values ('as observed'). N= number of valid cases"||units on a scale||Standard Deviation|Mean
805124|NCT00994760|Secondary|Caregiver: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ... (at Last Visit)|Scale: -3= very much improved, -2= much improved, -1= improved , 0= comparable, 1= worsened, 2= much worsened, 3= very much worsened|after therapy with Instanyl (at last visit)|"Patients included and treated with caregiver documentation (without imputation of missing values), ITT.
All patients with valid values ('as observed') =N."||units on a scale||Standard Deviation|Mean
805125|NCT00994760|Secondary|Caregiver: Assessment of Breakthrough Pain Therapy by Instanyl (Last Visit)|Scale: 1=very good, 2=good, 3=satisfactory, 4=poor, 5=very poor, 6=insufficient|after therapy with Instanyl (first/last visit)|"Patients included and treated with caregiver documentation (without imputation of missing values), intention to treat.
All patients with valid values ('as observed'). N= number of valid cases."||units on a scale||Standard Deviation|Mean
805126|NCT00994760|Secondary|Caregiver: Degree of Relief of Breakthrough Pain Achieved by Instany at Study End|0=no reduction, 1=slight, 2=medium, 3=strong, 4=very strong, 5=complete|after therapy with Instanyl (planned: 4 weeks)|"Patients included and treated with caregiver documentation (without imputation of missing values), ITT.
All patients with valid values at last visit. N= number of valid cases (=67). From the 70 participants analyzed, only 67 participants had valid values at the last visit."||units on a scale||Standard Deviation|Mean
805127|NCT00994760|Secondary|Patient: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ...(at Last Visit)|Scale: -3= very much improved, -2= much improved, -1= improved , 0= comparable, 1= worsened, 2= much worsened, 3= very much worsened|after therapy with Instanyl (at last visit)|"All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.
All patients with valid values ('as observed'). N= number of valid cases (=81). From the 83 participants analyzed, only 81 participants had valid values at the last visit."||units on a scale||Standard Deviation|Mean
810714|NCT01048606|Primary|Plasma Fibrinogen Levels Measured With Luminescence.||12 months||||||
805128|NCT00994760|Secondary|Patient: To What Extent Did Your Expectations in Instanyl Have Met With Respect to ... (Last Visit)|5=completely, 4=for the most part, 3=partially, 2=more or less, 1=rather not, 0=not at all|after therapy with Instanyl (planned: 4 weeks)|"Patients included and treated who filled in the patient's documentation with valid data (without imputation of missing values), intention to treat.
All patients with valid values at last visit. N= number of valid cases."||units on a scale||Standard Deviation|Mean
805129|NCT00994760|Secondary|Patient: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl)|Scale: 1=very good, 2=good, 3=satisfactory, 4=poor, 5=very poor, 6=insufficient|before and after therapy with Instanyl (first/last visit)|"All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.
All patients with valid values ('as observed')."||units on a scale||Standard Deviation|Mean
805130|NCT00994760|Secondary|Patient: Degree of Relief of Breakthrough Pain Achieved by Instanyl at Study End|0=no reduction, 1=slight, 2=medium, 3=strong, 4=very strong, 5=complete|after therapy with Instanyl (planned: 4 weeks)|"Patients included and treated who filled in the patient's documentation with valid data (without imputation of missing values), intention to treat.
All patients with valid values at last visit. N= number of valid cases (80). From the 83 participants analyzed, only 80 participants had valid values at the last visit."||units on a scale||Standard Deviation|Mean
805131|NCT00994760|Secondary|Patient: Marburg Questionnaire on Habitual Health (MQHH): Sum - Score (Complete Questionnaires Only) Conspicuous <1.5|conspicuous score <1.5 inconspicuous score ≥1.5|before and after therapy with Instanyl (first/last visit)|"All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.
All patients with valid values ('as observed'). N= number of valid cases."||participants|||Number
805132|NCT00994760|Secondary|Patient: Marburg Questionnaire on Habitual Health (MQHH): Sum - Score (Complete Questionnaires Only)|Scale: 0=worst, 5=best|before and after therapy with Instanyl (first/last visit)|"All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.
All patients with valid values ('as observed'). N= number of valid cases.
Initial Visit N=93
Last Visit N=81"||units on a scale||Standard Deviation|Mean
805133|NCT00994760|Secondary|Patient: Quality-of-Life-Impairment by Pain =QLIP - Sum - Score (Complete Questionnaires Only) Conspicuous ≤20|"0= conspicuous ≤20
1= inconspicuous >20"|before and after therapy with Instanyl (first/last visit)|"All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.
All patients with valid values ('as observed'). N= number of valid cases."||participants|||Number
805134|NCT00994760|Secondary|Patient: Quality-of-Life-Impairment by Pain =QLIP - Sum - Score (Complete Questionnaires Only)|Scale: 0=complete impairment, 43=no impairment|before and after therapy with Instanyl (first/last visit)|"All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.
All patients with valid values ('as observed'). N= number of valid cases.
Initial Visit N=93
Last Visit N=82"||units on a scale||Standard Deviation|Mean
805135|NCT00994760|Secondary|Patient: Modified Pain Disability Index (mPDI) - Sum - Score (Complete Questionnaires Only)|Scale: 0=no impairment, 70=complete impairment|before and after therapy with Instanyl (first/last visit)|"All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.
All patients with valid values ('as observed'). N= number of valid cases.
Initial Visit N=92
Last Visit N= 80"||units on a scale||Standard Deviation|Mean
805136|NCT00994760|Secondary|Patient: To What Extent Your Present Condition is Affected by Your Pain Attacks?|Scale: 0=not at all, 10=completely|before and after therapy with Instanyl (first/last visit)|"All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.
All patients with valid values ('as observed'). N= number of valid cases.
Initial Visit N=94
Last Visit N=83"||units on a scale||Standard Deviation|Mean
805137|NCT00994760|Secondary|Patient: How do You Feel Today?|Scale: 1=very bad, 2=bad, 3=mediocre, 4=good, 5=very good|before and after therapy with Instanyl (first/last visit)|"All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.
All patients with valid values ('as observed'). N= number of valid cases.
Initial Visit N=94
Last Visit N=83"||units on a scale||Standard Deviation|Mean
805138|NCT00994760|Secondary|Patient: Description of Pain at Initial Visit|0=no pain, 10= most intense pain imaginable|initial visit (before start of therapy with Instanyl)|"All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.
All patients with valid values ('as observed') =N."||units on a scale||Standard Deviation|Mean
805139|NCT00994760|Secondary|Patient: How Many Episodes of Pain You Experience on Average?||initial visit (before start of therapy with Instanyl)|"All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.
All patients with valid values ('as observed'). N= number of valid cases (= 91). From the 95 participants analyzed, only 91 participants had valid values at the last visit."||episodes per day||Standard Deviation|Mean
805140|NCT00994760|Primary|Physician: What is the Current Treatment Needs of Your Patient Regarding ...|Scale: 0=no, 1=low, 2=medium, 3=high|before and after therapy with Instanyl (first/last visit)|"All patients included and treated, intention to treat, missing values not imputed.
All patients with valid values ('as observed'). N= number of valid cases."||units on a scale||Standard Deviation|Mean
805141|NCT00994760|Primary|Physician: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ... (at Last Visit)|Scale: -3= very much improved, -2= much improved, -1= improved, 0= comparable, 1= worsened, 2= much worsened ,3= very much worsened|after therapy with Instanyl (at last visit)|"All patients included and treated, intention to treat, missing values not imputed.
All patients with valid values ('as observed'). N=number of valid cases."||units on a scale||Standard Deviation|Mean
805142|NCT00994760|Primary|Physician: To What Extent Did Your Expectations in Instanyl Have Met? (Last Visit)|5=completely, 4=for the most part, 3=partially, 2= more or less, 1=rather not, 0=not at all|after therapy with Instanyl (planned: 4 weeks)|"Patients included and treated with valid data (without imputation of missing values), intention to treat.
All patients with valid values at last visit. N= number of valid cases (=110). From the 116 participants analyzed, only 110 participants had valid values at the last visit."||units on a scale||Standard Deviation|Mean
810715|NCT01048606|Primary|Plasma Fibrinogen Levels Measured With Luminescence.||6 months||||||
805143|NCT00994760|Primary|Physician: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl)|Scale: 1=very good, 2=good, 3=satisfactory, 4=poor, 5=very poor, 6=insufficient|before and after therapy with Instanyl (first/last visit)|"All patients included and treated, intention to treat, missing values not imputed.
All patients with valid values ('as observed')= N."||units on a scale||Standard Deviation|Mean
805144|NCT00994760|Secondary|Physician: Degree of Relief of Breakthrough Pain Achieved by Instanyl at Study End|0=no reduction, 1=slight, 2=medium, 3=strong, 4=very strong, 5=complete|after therapy with Instanyl (planned: 4 weeks)|"Patients included and treated with valid data (without imputation of missing values), intention to treat.
All patients with valid values at last visit. N= number of valid cases (=114). From the 116 participants analyzed, only 114 participants had valid values at the last visit."||units on a scale||Standard Deviation|Mean
805145|NCT00994760|Primary|Physician: Degree of Maximum Pain Intensity During the Last Days/ Since the Last Examination|Scale: 0=no, 1=mild, 2=moderate, 3=strong, 4=very strong, 5=extreme|before and after therapy with Instanyl (first/last visit)|"All patients included and treated, intention to treat, missing values not imputed.
All patients with valid values ('as observed'). N= number of valid cases."||units on a scale||Standard Deviation|Mean
805146|NCT00994760|Primary|Dose of Instanyl|Initially prescribed dose/ most efficient single dose of Instanyl at study end|during therapy with Instanyl (planned: 28 days)|"Patients included and treated (without imputation of missing values), intention to treat.
All patients included"||participants|||Number
805147|NCT00994929|Secondary|The Mechanism of Study Drug Effect by VWF mRNA.||within 11 days of study drug.|||fold increase||Full Range|Mean
805148|NCT00994929|Secondary|The Frequency of Adverse Events||within 11 days of study drug|||participants|||Number
805149|NCT00994929|Primary|Biologic Effects by Coagulation Tests|VWF activity was measured by ristocetin-induced platelet agglutination using a Chronolog aggregometer11-14 and VWF:Ag by “sandwich” ELISA, using anti-VWF antibodies (DakoA082, Carpintera CA). Results were expressed in percent, with normal human plasma pool designated 100%, and severe type 3 VWD plasma used as the negative control|within 4 days of study drug.|Four subjects had VWD and five subjects had mild hemophilia A||percentage of normal||Standard Error|Mean
805150|NCT00995007|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|70 months and 19 days|||participants|||Number
805151|NCT00995007|Secondary|Overall Survival|Time between the first day of treatment and the day of death.|Time between the first day of treatment and the day of death, up to 1.5 years|The group data is displayed per the report provided to the Food and Drug Administration.||Months||95% Confidence Interval|Median
805152|NCT00995007|Primary|Progression Free Survival at 6 Months|Percentage of participants who are alive and progression-free at 6 months.|6 months|The group data is displayed per the report provided to the Food and Drug Administration.||percentage of participants|||Number
805153|NCT00995020|Secondary|Time Spent to Perform the Procedure|Time was recorded from insertion until removal of the vaginal speculum.|Time spent from randomization to complete the procedure|||minuts||Standard Deviation|Mean
805154|NCT00995020|Primary|Endocervical Margin Not Free of Disease.|Primary outcome is the number of participants with incomplete excision of dysplasia at the endocervical excision margin as recognized histologically.|3 months after the surgery is performed.|All data were analysed bu intention to treat.||participants|||Number
805155|NCT00995085|Primary|Safety and Tolerability|Subjects were evaluated for general safety and tolerablity measures, including number of AEs and AEs related (possibly or likely) to study drug|24 hours after drug adminstration|||events|||Number
805156|NCT00995345|Secondary|Percentage of Patients Requiring Rescue Therapy for Elevated Glucose|Percentage of Subjects Requiring Rescue Therapy – Intent-to-Treat Population|24 weeks of treatment.|||% of subjects in group|||Number
805157|NCT00995345|Secondary|Percentage of Patients Achieving HbA1c Less Than 7%|Subjects Achieving Target of Hemoglobin A1c <7.0% at Week 24 with LOCF – Intent-to-Treat Population|24 weeks|||% of subjects in group|||Number
805158|NCT00995345|Secondary|Change in Body Weight|Mean Change in Body Weight (kg) from Baseline to Week 24 with LOCF- ITT|24 weeks|||kg body weight on scale||Standard Error|Least Squares Mean
805159|NCT00995345|Primary|Change in HbA1c From Baseline (Week 0) to Week 24|Mean Change in HbA1c (%) from Baseline to Week 24 with LOCF, ITT population LS mean (SE)|Week 24|Conducted analyses of ITT population of change in HbA1c from baseline (Week 0) to Week 24. If the Wk 24 measurement was missing, the last valid post-baseline observation (LOCF) algorithm was used to impute Week 24 value (1 on-treatment value required). Efficacy data collected after the initiation of rescue therapy was excluded from the analyses.||% HbA1c||95% Confidence Interval|Least Squares Mean
805160|NCT00995371|Primary|Mean Change in ODI|"Oswestry Disability Index (ODI) measures permanent functional disability using questions regarding activities of daily living (ADL), specifically disturbance in ADL related to chronic back pain. Higher score indicate a ‘more limited’ life.
The ten topics of the ODI are rated from zero (no pain/limitation) to five (high pain/very limited physically). Calculated values range from zero (0% disability) to 100 (100% disability). The change from baseline to 6 weeks for all participants is presented below, where a positive value represents the baseline value minus the 26 week value"|Baseline and 26 weeks After ESI to mild cross-over|Participants who reported Week 26 outcomes. All findings reported below for the ESI group are after cross-over to mild.||units on a scale||95% Confidence Interval|Mean
805161|NCT00995371|Primary|Mean Change in VAS|Visual Analog Scale (VAS) - a validated ten point scale where ten is the worst possible pain and zero represents complete lack of pain. The change from baseline to 26 weeks for all participants is presented below, where a positive value represents the baseline value minus the 26 week value.|Baseline and 26 weeks After ESI to mild cross-over|Participants who reported Week 26 outcomes. All findings reported below for the ESI group are after cross-over to mild.||units on a scale||95% Confidence Interval|Mean
805179|NCT00995566|Primary|Adverse Events (AEs) by Seriousness and Relationship to Treatment|Counts of participants who had AEs or treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Serious adverse events (SAEs) were reported from the time of informed consent. Relatedness to Thelin was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.|Baseline up to year 1|FAS||participants|||Number
810716|NCT01048606|Primary|Quality of Life: Assessed With Questionnaires (SF-36 (General Health Perceptions), Kupperman Index, Perceived Stress Scale||12 months||||||
805162|NCT00995371|Primary|Mean Change in ODI|"Oswestry Disability Index (ODI) measures permanent functional disability using questions regarding activities of daily living (ADL), specifically disturbance in ADL related to chronic back pain. Higher score indicate a ‘more limited’ life.
The ten topics of the ODI are rated from zero (no pain/limitation) to five (high pain/very limited physically). Calculated values range from zero (0% disability) to 100 (100% disability). The change from baseline to 6 weeks for all participants is presented below, where a positive value represents the baseline value minus the 6 week value"|Baseline and 6 weeks prior to cross-over|All 38 participants (21 in mild and 17 in ESI arm) reported ODI at Week 6 post-treatment. All measurements for the ESI group occurred prior to cross-over to the mild procedure. This is Intent to Treat (ITT) analysis.||units on a scale||95% Confidence Interval|Mean
805163|NCT00995371|Primary|Mean Change in VAS|Visual Analog Scale (VAS) - a validated ten point scale where ten is the worst possible pain and zero represents complete lack of pain. The change from baseline to 6 weeks for all participants is presented below, where a positive value represents the baseline value minus the 6 week value.|Baseline and 6 weeks prior to cross-over|All 38 participants (21 in mild and 17 in ESI arm) reported VAS at Week 6 post-treatment. All measurements for the ESI group occurred prior to cross-over to the mild procedure. This is Intent to Treat (ITT) analysis.||units on a scale||95% Confidence Interval|Mean
805164|NCT00995410|Secondary|Most Frequent Treatment Emergent Adverse Events Leading to Study Drug Discontinuation|Most Frequent (≥ 1%) Treatment Emergent Adverse Events by System Organ Class leading to Discontinuation|12 months|Overall Safety Population. Events were collected by systematic assessment. One subject reported two adverse events leading to discontinuation from the study. SOC from vocabulary, MedDRA (12.1).||participants|Participants||Number
805165|NCT00995410|Primary|Number of Subjects Monitored for Long-term Safety of PA32540|Incidence of adverse events and monitoring vital signs and clinical laboratory values. All AEs were coded into preferred terms according to MedDRA (Medical Dictionary for Regulatory Activities) and classified by system organ class (SOC).|12 months|||participants|||Number
805166|NCT00995436|Secondary|Patient Perception of the Different Treatment Methods, Including Surgical Experience||2 years||||||
805167|NCT00995436|Primary|Anchorage Loss Measured From 3-D Model Scanning||2 years|||mm||Standard Deviation|Mean
805168|NCT00995449|Primary|This Study Was Initiated With a Safety run-in Period to Evaluate Acceptability of Repeat-dose Safety.|KB003 was administered by intravenous (IV) infusion as a 600 mg dose at weeks 0, 2, 4, 8, and 12, with primary safety being evaluated at week 14 and a follow-up (end of study) safety assessment at week 30. Safety was evaluated by number of participants with treatment-emergent (TE) adverse events (AEs). (TE is defined as ocurring during the 14 week treatment and week 30 follow-up periods)|Weeks 14 & 30|This safety run-in portion of the study was conducted in a small cohort of 7 active (600 mg) and 2 placebo subjects.||Participants|||Number
805169|NCT00995488|Secondary|Median Overall Survival|The Median Overall Survival was captured in months.|2 years|16 participants began treatment however one patient withdrew from the study and was therefore not evaluable.||months||95% Confidence Interval|Median
805170|NCT00995488|Primary|Percentage of Participants With a Partial or Complete Response|"Clinical efficacy of ABI-007 based therapy will be determined by the overall response rate (Partial Response [PR] + Complete Response[CR]) to therapy.
Partial Response: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions.
Complete Response: Disappearance of all target lesions."|2 years|16 participants began treatment however one patient withdrew from the study and was therefore not evaluable.||percentage of participants||95% Confidence Interval|Number
805171|NCT00995501|Secondary|1 Year Mortality|All-cause mortality|1 year after surgery|||Participants|||Count of Participants
805172|NCT00995501|Primary|Major Perioperative Morbidity|Our primary outcome was a collapsed composite endpoint (any versus none) defined as the occurrence of at least one of sixteen major complications before hospital discharge, including sepsis, severe surgical site infection, myocardial infarction, heart failure, stroke, unstable ventricular arrhythmias, pulmonary embolism, pneumonia, respiratory failure, dialysis dependent renal failure, large pleural or peritoneal effusions, major bleeding, major wound and surgical site healing complications, vascular graft thrombosis, and 30-day mortality.|30 day after surgery|||Participants|||Count of Participants
805173|NCT00995553|Secondary|Functional Capacity - University of California, San Diego Performance-Based Skills Assessment|The UPSA is a measure of the ability to apply cognitive skills to functional tasks. The total score from this scale was used. Scores may range from 0 - 100, with higher scores being better.|Post-intervention, within 2 weeks of completion of the 4 month intervention|All participants who engaged in the intervention, defined as completing at least 3 sessions, were included in an Intent to Treat analysis. 80 of the 81 participants who started one of the study conditions met this definition of engagement. One participant who attended only 1 session of computer skills was excluded from the analysis.||units on a scale||Standard Deviation|Mean
805174|NCT00995553|Primary|Cognitive Assessment - MATRICS Consensus Cognitive Battery|The Working Memory and Attention indexes of the MATRICS Consensus Cognitive Battery was used to assess near generalization of training with untrained tasks that were conceptually similar to training tasks. Each scale provide an age and gender corrected T-score. Thus, scores can range from 0-100, with a higher score indicating better performance.|Post-intervention, within 2 weeks of completion of the 4 month intervention|All participants who engaged in the intervention, defined as completing at least 3 sessions, were included in an Intent to Treat analysis. 80 of the 81 participants who started one of the study conditions met this definition of engagement. One participant who attended only 1 session of computer skills was excluded from the analysis.||T-score||Standard Deviation|Mean
805175|NCT00995566|Primary|Percentage of Participants Who Experienced Pulmonary Edema With the Presence of Veno-occlusive Disease|The criteria used to determine whether participants had both pulmonary edema and veno-occlusive disease was at the discretion of the Investigator.|Baseline up to year 1|FAS||percentage of participants|||Number
805176|NCT00995566|Primary|Bleeding AEs by Seriousness, Relationship to Treatment, Endothelin-A Receptor Antagonist (ERA) Usage, and International Normalized Ratio (INR) Results|Counts of participants who had bleeding events or treatment-emergent bleeding events, defined as newly occurring or worsening after first dose. Serious bleeding events reported from time of informed consent. Relatedness to Thelin assessed by investigator (Yes/No). ERA usage: was participant taking Vitamin K antagonist? (Yes/No). INR: participant's prothrombin time (PT) ratio. Participants with multiple occurrences of an AE within a category were counted once within the category.|Baseline up to year 1|FAS||participants|||Number
805181|NCT00995566|Primary|Percentage of Participants With Increases in Total, Conjugated and Non-conjugated Bilirubin Post-baseline|Total and conjugated bilirubin levels measured from blood, but indirect bilirubin calculated. Indirect bilirubin=Total bilirubin - Conjugated bilirubin. Laboratory data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analyses.|Monthly up to 1 year|Data not summarized due to the small number of participants in database.||percentage of participants|||Number
805182|NCT00995566|Primary|Percentage of Participants With a Decrease in Hemoglobin Post-baseline|Laboratory data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analyses.|Monthly up to 1 year|Data not summarized due to the small number of participants in database.||percentage of participants|||Number
805183|NCT00995566|Primary|Percentage of Participants With Elevated Liver Function Post-baseline|Elevated liver function: greater than 3 times the upper limit of normal (>3 x ULN) alanine aminotransferase (ALT) and aspartase aminotransferase (AST) levels. Laboratory data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analyses.|Monthly up to 1 year|Full Analysis Set (FAS): participants enrolled in Patient Registry of Sitaxentan in Europe (PROSE). Number of participants analyzed (N): participants with evaluable data.||percentage of participants|||Number
805184|NCT00995670|Primary|Forearm Blood Flow|endothelial (forearm blood flow) responses to acetylcholine stimulation at baseline, and under conditions of high glucose before and after ischemia/reperfusion injury, and same with the addition of an intervention: sevoflurane (Arm 1), vitamin C (Arm 2), and high statin (Arm 3).|Baseline, Glucose Control, 15-min post ischemia|||ml/100 ml tissue/min||Standard Error|Mean
805185|NCT00995709|Primary|Rate of Recurrent Ocular Exacerbations in the Study Eye During 24 Weeks by Treatment|Patients number of occurences during a 24 week period.|24 weeks|Full analysis set||Participants|||Number
805186|NCT00995709|Secondary|To Observe the Effect of AIN457 on the Systemic Non-ocular Manifestations of Behçet’s Disease in Patients With Posterior Segment Uveitis Requiring Systemic Immunosuppression as Measured by the Bechet’s Disease Current Activity Form.|The BDCAF scores oral and genital ulceration, skin, joint and gastrointestinal involvement, presence of fatigue and headache according to the duration of symptoms. The presence and type of large-vessel and central nervous system (CNS) involvement are documented. Eye activity was deemed present if there was a history of blurring of vision or if the eye was painful or red. . The BDCAF score was calculated by adding the score of each index and ranged between 0 and 12 A reduction in score signifies a lessening of the disease.|baseline and wk 24 (end of study)|Full Analysis set||change from baseline score||Standard Deviation|Mean
805187|NCT00995709|Secondary|To Establish the Impact of AIN457 on Quality of Life of Posterior Segment Uveitis Patients Secondary to Behçet’s Disease Refractory to Systemic Immunomodulatory Therapy as Measured by National Eye Institute Visual Function Questionaire-25 and Euroqol.|The VFQ-25 is a reliable and valid 25-item version of the 51-item National Eye Institute Visual Function Questionnaire (NEI-VFQ). It is especially useful in settings such as clinical trials, where interview length is a critical consideration. Scores range from 0 to 100, with higher scores indicating better visual function.|screening, and wk 24 (end of study)|Full Analysis Set||Score||Standard Deviation|Mean
805188|NCT00995709|Secondary|To Determine the Effect of AIN457 on Macular Edema and Visual Acuity in Patients With Posterior Segment Uveitis Secondary to Behçet’s Disease as Determined by Optical Coherence Tomography.|Optical coherence tomography (OCT) is amedical imaging technique that uses light to capture micrometer-resolution, three-dimensional images from within optical scattering media (e.g., biological tissue). OCT is based on low-coherence interferometry, typically employing near-infrared light. The use of relatively long wavelength light allows it to penetrate into the scattering medium. OCT is a noninvasive procedure that uses optical interferometry to visualize the structures within the retina. Following dilation of the pupil, a light source operating at 850nm provides probe illumination which is split and detected with and without the refraction of the retinal tissues. Cross-sectional imaging is accomplished in 1.3 second by acquiring a sequence of interferometric A-scans. A false color tomogram of optical reflectivity is produced by the computer. Central foveal thickness will be the primary variable derived from OCT. A increase in thickness could translate to disease progression.|baseline, and wk 24 (end of study)|(Full Analysis Set)||change from baseline : micrometers||Standard Deviation|Mean
805189|NCT00995709|Secondary|Change From Baseline for Composite Immunosuppressive Medication Score at Week 24 by Treatment (Full Analysis Set)|For each corticosteroid medication, dose of the corticosteroid was first converted to a prednisone-equivalent dose. To determine the prednisone equivalent dose, the corticosteroid dose was multiplied by a conversion factor. . The total prednisone equivalent dose was calculated as the sum of the prednisone equivalent doses of all corticosteroids. Consequently, the total converted prednisone equivalent dose was used to obtain the immunosuppressive score. The key secondary efficacy variable was the change in total post-baseline immunosuppressive medication score from baseline.The score is actually the prednisoone equivalents taken by patient as calculated by conversion table. A reduction in prenisone or prenisone equivalents is a positive outcome. An increase in the number of prednisone equivalents suggests that the treatment is not efficacious or that there is disease progression. A score of 0 would be the lowest ( no steriods taken) and the upper limit is indeterminate.|24 weeks|Full Analysis Set||immunosuppressive medication score||Standard Deviation|Mean
805190|NCT00995709|Primary|Rate of Recurrent Ocular Exacerbations in the Study Eye During 24 Weeks by Treatment||Baseline to week 24|Full Analysis Set||Ocular Exacerbations||Standard Deviation|Mean
806270|NCT01012167|Secondary|Laboratory Measures - Sodium|Sodium blood levels by treatment group and visit.|Once during evaluation and once at the end of 6 weeks of study treatment|Available participant lab data at Evaluation and Week 6.||mE/qL||Standard Deviation|Mean
805196|NCT00995761|Primary|We Conducted the Present Phase II Study to Investigate the Efficacy and Safety of a Biweekly Schedule of Docetaxel and Cisplatin in Patients With Unresectable NSCLC.|we conducted the present phase II study to investigate the efficacy and safety of a biweekly schedule of docetaxel and cisplatin in patients with unresectable NSCLC (OS, TTP, and Others)|after every 2 cycles of docetaxel and cisplatin||12/2012||||
805197|NCT00995761|Secondary|Time to Progression and Overall Survival Confirmed Through Follow-up and Observation Following Treatment||From date of enrollment in this study until the date of first documented progression or date of death from any cause, whichever came first, after every 2 cycles of docetaxel and cisplatin||||||
805198|NCT00995761|Primary|Response Rates Confirmed With CT or MRI|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
During treatment, a limited history, physical examination, assessment of toxicity, CBC with differentials, and blood chemistry tests were repeated weekly. A chest X-ray was performed every 2 weeks before each cycle. Appropriate imaging studies, including CT scans of the chest and upper abdomen, were performed every two cycles to assess the treatment response, and sooner, if required, to document disease progression. Objective tumor responses were assessed according to the RECIST criteria V 1.0."|after every 2 cycles of docetaxel and cisplatin|The sample size was calculated according to Simon's two-stage optimal design.The statistical evaluation was performed based on an ITT analysis. Descriptive statistics are reported as proportions and medians. OS and TTP were assessed by the K-M method, and the 95% CI for the median time to events was computed.||percentage of participants||95% Confidence Interval|Number
805199|NCT00995774|Secondary|A Motion Analysis Evaluation Will be Performed on Reach and Grasp Tasks. The Kinematics Will be Measured Using an Electromagnetic Tracker (Flock of Birds, Ascension Technology Corp., Burlington VT).||pre-treatment, post treatment||||||
805200|NCT00995774|Secondary|Action Research Arm Test|This scale is a standardized assessment of functional limitations in the upper extremity. Individual subscores are summed to create a total score that ranges from 0 to 57 points. A score of 57 indicates no functional limitations.|before Training Period 1, after Training Period 1, before Training Period 2, after training Period 2|||units on a scale||Standard Deviation|Mean
805201|NCT00995774|Primary|Fugl-Meyer Test of Motor Function|This scale assesses motor impairments at the shoulder, elbow, wrist and fingers (Fugl-Meyer 1975). Individual subscores are added to create a total score that ranges from 0 to 66 points. A score of 66 indicates no impairment.|before Training Period 1, after Training Period 1, before Training Period 2, after training Period 2|||units on a scale||Standard Deviation|Mean
805202|NCT00995865|Primary|The Incidence and Severity of Adverse Events in Each Treatment Group in the Double-blind Treatment Period up to 42 Days Post-vaccination.|"Subjects were observed for 60 minutes (greater than of equal to 60 minutes and less than of equal to 90 minutes) after vaccine adminstration for any signs or symptoms or local and/or systematic intolerance to the test articles and vital signs were to be checked within the same observation timeframe.
After vaccination, subjects were to complete a memory aid to record daily temperature, symptoms, and concomitant medications from Day-0 to Day-42.
Subjects were to return to the clinic on Days 3, 10, 21, 24, 31, and 42 with a second vaccination given on Day 21.
At each visit, study personnel were to conduct a structured adverse event (AE) interview, and subject were to use their memory aid to assist with the recall of symptoms experiences and daily oral temperatures."|Measured from 22 up to 42 Days.|Subjects were to combined at days 22 to 42 . At each visit, study personnel were to conduct a structured adverse event (AE) interview, and subject were to use their memory aid to assist with the recall of symptoms experiences and daily oral temperatures.||participants|||Number
805203|NCT00995865|Secondary|Distribution of Geometric Mean Antibody Titers (GMTs) to Yellow Fever 17D Virus.|Geometric mean antibody titers (GMT) neutralizing antibody titers for each dose groups.|GMT titers measured at days 21, 31 and 42 for different dose rates.|||Geometric Antibody titers||95% Confidence Interval|Geometric Mean
805204|NCT00995865|Secondary|Percentage of Subjects With Seroconversions or Who Are Seropositive Using 2 Dose Levels of XRX-001|Secondary immunogenicity endpoints will use 2 dose levels of XRX-001 inactivated yellow fever vaccine determined by 50% plaque reduction neutralization test (PRNT50). Dose groups were to be compared for neutralizing antibody seroconverison rate, distribution of antibody titers, and geometric mean antibody titers (GMTs) to yellow fever 17D virus. The seroconversion rates and GMT neutralizing antibody titers for each dose group and all dose groups combined; The reverse cumulative distribution curve of antibody titers;|Days 21 and 42, 12 months|Seropositive was to show a significant level of serum antibodies, or other immunologic marker in the serum, indicating previous exposure to the infectious agent being tested. In immunology, seroconversion is the time period during which a specific antibody develops and becomes detectable in the blood.||Percentage of subjects||95% Confidence Interval|Number
805205|NCT00995865|Primary|The Incidence and Severity of Adverse Events in Each Treatment Group in the Double-blind Treatment Period up to 42 Days Post-vaccination.|"Subjects were observed for 60 minutes (greater than of equal to 60 minutes and less than of equal to 90 minutes) after vaccine adminstration for any signs or symptoms or local and/or systematic intolerance to the test articles and vital signs were to be checked within the same observation timeframe.
After vaccination, subjects were to complete a memory aid to record daily temperature, symptoms, and concomitant medications from Day-0 to Day-42.
Subjects were to return to the clinic on Days 3, 10, 21, 24, 31, and 42 with a second vaccination given on Day 21.
At each visit, study personnel were to conduct a structured adverse event (AE) interview, and subject were to use their memory aid to assist with the recall of symptoms experiences and daily oral temperatures."|Measured from 0 up to 21 Days|Subjects were to return to the clinic on Days 3,10, 21, 24, 31,and 42 with the second vaccination given on Day 21. At each visit, study personnel were to conduct a structured adverse event (AE) interview, and subject were to use their memory aid to assist with the recall of symptoms experiences and daily oral temperatures.||participants|||Number
805206|NCT00995904|Primary|Half-life (t1/2) of Budesonide After Administration of MAP0020|Half-life (t1/2) is the time for the drug to decrease to half of its maximum concentration. Budesonide t1/2 is reported in minutes.|12 hours|Patients with available data at specified time points are included in the analysis population.||minutes||Standard Deviation|Mean
810717|NCT01048606|Primary|Quality of Life: Assessed With Questionnaires (SF-36 (General Health Perceptions), Kupperman Index, Perceived Stress Scale||6 months||||||
805207|NCT00995904|Primary|AUC(0-inf) of Budesonide After Administration of MAP0020|The AUC(0-inf) is the area under the plot of plasma concentration of drug to time infinity after drug administration. Budesonide AUC(0-inf) is reported in picograms times minutes per milliliter (pg*min/ml).|12 hours|Patients with available data at specified time points are included in the analysis population.||pg*min/ml||Standard Deviation|Mean
805208|NCT00995904|Primary|Cmax of Budesonide After Administration of MAP0020|The maximum concentration (Cmax) is the highest concentration of a drug measured in the plasma. Plasma is the clear portion of the blood. The Cmax of Budesonide is reported in picograms per milliliter (pg/ml).|12 hours|Patients with available data at specified time points are included in the analysis population.||pg/ml||Standard Deviation|Mean
805209|NCT00995930|Secondary|Pharmacokinetics: ACZ885 Serum Concentrations|Blood samples were collected to analyze the ACZ885 serum concentrations.|pre-dose, 0.167 day post dose 1, 7 days post dose 1, 14 days post dose 1, every 30 days post each dose from doses 1 through 12, 60 days post dose 12, 90 days post dose 12|Only participants from the PK analysis set, who had evaluable data at each time point, were included in the analysis for that time point. The PK analysis set included randomized participants from the ACZ885 arm who received at least one dose of study medication.||ng/mL||Standard Deviation|Mean
805210|NCT00995930|Secondary|Change From Baseline Insulin Resistance (HOMA-IR)|Blood samples were collected to analyze insulin resistance. Insulin resistance was calculated by the Homeostasis Model Assessments of insulin resistance (HOMA-IR)) as follows: HOMA-IR: The product of basal glucose (mmol/L) and insulin (µU/mL) levels divided by 22.5 [i.e., HOMA-IR = basal glucose*basal insulin/22.5].|baseline, 3 months, 12 months|Only participants from the PD analysis set, who had evaluable data at both baseline and the given post-baseline time point, were included in the analysis for that post baseline time point. The PD analysis set included randomized participants who received at least one dose of study medication.||IR score||95% Confidence Interval|Geometric Mean
805211|NCT00995930|Secondary|Change From Baseline in Beta Cell Function (HOMA-B)|Blood samples were collected to analyze beta cell function. Beta cell function was calculated by the Homeostasis Model Assessments (of beta cell function (HOMA-B) as follows: HOMA-B: The product of 20 and basal insulin (µU/mL) levels divided by the value of basal glucose (mmol/L) concentrations minus 3.5 [i.e., HOMA-B = 20*basal insulin/(basal glucose-3.5)].|baseline, 3 months, 12 months|Only participants from the PD analysis set, who had evaluable data at both baseline and the given post-baseline time point, were included in the analysis for that post baseline time point. The PD analysis set included randomized participants who received at least one dose of study medication.||percentage of beta cell function||95% Confidence Interval|Geometric Mean
805212|NCT00995930|Secondary|Change From Baseline in 2 Hour Glucose Post Oral Glucose Tolerance Test (OGTT)|Blood samples were collected to analyze the 2 hour glucose post OGTT.|baseline, 3 months, 12 months|Only participants from the PD analysis set, who had evaluable data at both baseline and the given post-baseline time point, were included in the analysis for that post baseline time point. The PD analysis set included randomized participants who received at least one dose of study medication.||mmol/L||95% Confidence Interval|Geometric Mean
805213|NCT00995930|Secondary|Change From Baseline in Hemoglobin A1c (HbA1c)|Blood samples were collected to analyze HbA1c.|baseline, 3 months, 12 months|Only participants from the PD analysis set, who had evaluable data at both baseline and the given post-baseline time point, were included in the analysis for that post baseline time point. The PD analysis set included randomized participants who received at least one dose of study medication.||percentage||95% Confidence Interval|Geometric Mean
805214|NCT00995930|Secondary|Change From Baseline in Fasting Plasma Glucose|Blood samples were collected to analyze fasting plasma glucose.|baseline, 3 months, 12 months|Only participants from the PD analysis set, who had evaluable data at both baseline and the given post-baseline time point, were included in the analysis for that post baseline time point. The PD analysis set included randomized participants who received at least one dose of study medication.||mmol/L||95% Confidence Interval|Geometric Mean
805215|NCT00995930|Secondary|Change From Baseline in High Sensitivity C-reactive Protein (hsCRP)|Blood samples were collected to analyze hsCRP.|baseline, 3 months, 12 months|Only participants from the PD analysis set, who had evaluable data at both baseline and the given post-baseline time point, were included in the analysis for that post baseline time point. The PD analysis set included randomized participants who received at least one dose of study medication.||mg/L||95% Confidence Interval|Geometric Mean
805216|NCT00995930|Secondary|Change From Baseline in Aortic Strain|Arterial strain was computed directly from the cine SSFP images and the change in lumen diameters over the cardiac cycle. The value was independent of pulse pressure and is unitless ratio derived from the maximum to minimum lumen diameters diastole and systole, respectively..|baseline, 3 months, 12 months|Only participants from the imaging analysis set, who had evaluable data at both baseline and the given post-baseline time point, were included in the analysis for that post baseline time point. The imaging analysis set included randomized participants who received at least one dose of study medication.||ratio||Standard Error|Least Squares Mean
805217|NCT00995930|Secondary|Change From Baseline in Plaque Composition|During the carotid MRI acquisition, in addition to the PD weighted ECG gated double inversion fast spin echo sequences T1 and T2 weighted sequences were acquired. In combination with the PD weighted images, the multi-contrast images were analyzed to determine regions of interest with contrast patterns consistent with the presence of necrotic lipid core, calcification and fibrous tissue in participants who had complex carotid plaque present in the bifurcation region.|baseline, 3 months, 12 months|Only participants from the imaging analysis set, who had evaluable data at both baseline and the given post-baseline time point, were included in the analysis for that post baseline time point. The imaging analysis set included randomized participants who received at least one dose of study medication.||mm^2||Standard Deviation|Mean
805218|NCT00995930|Secondary|Change From Baseline in Pulse Wave Velocity and Pulse Wave Velocity Error|Utilizing the SphygmoCor Device, ECG leads placed at the carotid and femoral arteries provided the measure of the pulse wave at that particular arterial location. The distance between the two vascular beds divided by the pulse wave time shift provided a measure of the pulse wave velocity.|baseline, 3 months, 12 months|Only participants from the imaging analysis set, who had evaluable data at both baseline and the given post-baseline time point, were included in the analysis for that post baseline time point. The imaging analysis set included randomized participants who received at least one dose of study medication.||ms^-1||Standard Error|Least Squares Mean
805219|NCT00995930|Primary|Change From Baseline in Plaque Burden (Aortic Vessel Wall Area and Carotid Vessel Wall Area)|For assessment of atherosclerotic plaque burden of the aorta, vessel wall images of the aorta were acquired with an ECG gated double-inversion recovery (black blood) fast spin echo sequence applied breath-holding. Using an oblique sagittal image of the aorta as a pilot, serial axial images were acquired to cover a section of the descending thoracic aorta. The midpoint of the right pulmonary artery in cross section was used as the anatomical reference for the first slice in baseline and follow-up scans. For assessment of the atherosclerotic plaque burden in the carotids, vessel wall images were acquired with an axial ECG gated PD (proton density) weighted black blood sequence. The carotid bifurcation was used as the anatomical reference for all three imaging time points (baseline, 12 weeks, 48 weeks) with axial slice planes acquired below the bifurcation region. The mean values reported here for the carotid are reported for the proximal common carotid region.|baseline, 3 months, 12 months|Only participants from the imaging analysis set, who had evaluable data at both baseline and the given post-baseline time point, were included in the analysis for that post baseline time point. The imaging analysis set included randomized participants who received at least one dose of study medication.||mm^2||Standard Error|Least Squares Mean
805220|NCT00995930|Primary|Change From Baseline in Aortic Distensibility|Two axial, ECG-gated, steady state free precession (SSFP) ‘cine’ images were acquired during breath-hold to determine aortic distensibility. The first image was obtained at the level of the right pulmonary artery through the ascending and proximal descending aorta and the second through the distal aorta below the diaphragm. Imaging of the aorta also enabled evaluation of the plaque burden and additional vascular function measures.|baseline, 3 months, 12 months|Only participants from the imaging analysis set, who had evaluable data at both baseline and the given post-baseline time point, were included in the analysis for that post baseline time point. The imaging analysis set included randomized participants who received at least one dose of study medication.||mmHg^-1||Standard Error|Least Squares Mean
805221|NCT00995930|Primary|Number of Participants With Adverse Events, Serious Adverse Events and Death|Participants were monitored for adverse events, serious adverse events and death throughout the study.|12 months|Safety analysis set: The safety analysis set included all randomized participants who received at least one dose of study drug.||Number of participants|||Number
805222|NCT00996034|Primary|Mean of the Average Nicotine Binding % at Scan 1 and Scan 2|nAchR levels from baseline and after immunization with 3’-AmNic-rEPA (NicVAX=vaccine) SPECT images obtained in healthy control smoking subjects at baseline and after immunization with 3’-AmNic-rEPA (NicVAX=vaccine). nAchR levels will be determined by radioligand uptake in SPECT images. Means were calculated for all subjects at scan 1 and scan 2.|3 months|||percentage of average nicotine binding||Standard Deviation|Mean
805223|NCT00996125|Primary|Geometric Mean Titers (GMTs) for Antibodies Against Human Papillomavirus (HPV)-16/18 Antigens|Titers were given as geometric mean titers and were measured by Enzyme-linked Immunosorbent Assay (ELISA) and expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).|One month after the third dose (at Month 7)|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included subjects who received 3 doses of the study vaccine or placebo and for whom data concerning immunogenicity measures were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
805224|NCT00996125|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|Throughout the study period (from Day 0 up to Month 12)|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||Subjects|||Number
805225|NCT00996125|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.|Within 30 days (Days 0 – 29) after any vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||Subjects|||Number
805226|NCT00996125|Secondary|Number of Subjects Reporting Pregnancies and Pregnancy Outcomes||Throughout the study period (from Day 0 up to Month 12)|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||Subjects|||Number
805227|NCT00996125|Secondary|Number of Subjects Reporting Medically Significant Conditions (MSCs)|"Medically significant conditions (MSCs) are defined as: adverse events (AEs) prompting emergency room or physician visits that are not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.
MSCs were collected regardless of causal relationship to vaccination and intensity."|Throughout the study period (from Day 0 up to Month 12)|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||Subjects|||Number
805228|NCT00996125|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, urticaria and fever (= axillary temperature above 37.0 degrees Celsius (°C). Grade 3 fever = axillary temperature above 39.0°C. Grade 3 urticaria = urticaria distributed on at least 4 body areas. For other symptoms, any = occurrence of any general symptom regardless of intensity grade or relation to vaccination and grade 3 = a general symptom that prevented normal activity. Related was a general symptom assessed by the investigator as causally related to the study vaccination.|During the 7 days (Days 0 – 6) following each vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.||Subjects|||Number
810718|NCT01048606|Primary|Sex-hormone Levels. Estradiol, Estrone, Progesterone, Testosterone and SHBG Will be Obtained by Enzyme Immuno Assay (EIA)||12 months||||||
805229|NCT00996125|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeter (mm).|During the 7 days (Days 0 – 6) following each vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.||Subjects|||Number
805230|NCT00996125|Secondary|Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies|Seroconversion is defined as the appearance of anti-HPV-16 and/or anti- HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination. Cut-off values were 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti- HPV-18 antibodies.|At Month 7|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity on initially seronegative subjects for whom data concerning immunogenicity measures were available.||Subjects|||Number
805231|NCT00996164|Primary|Change From Baseline in the SSE Count From Baseline to 24 Weeks|"The change from baseline in the number of Satisfying Sexual Events (SSEs) as measured by the eDiary. The SSEs will be standardized to a 28-day period according to the below formula:
Total monthly events = 28 x (sum of the number of events) / (sum of number of days entered).
Satisfying means gratifying, fulfilling, satisfactory, and/or successful for the patient. The partner's satisfaction is not the subject of this question.
An eDiary was used by the patients to record information about sexual events. Patients were instructed to complete the eDiary every morning. When completing an eDiary entry, patients answered questions regarding their sexual events since their last eDiary entry. If patients missed or were late with their eDiary entry, they entered information about their sexual events covering a maximum time period of the past 7 days; however, they did not enter any information beyond the last entry."|24 weeks|The Full Analysis Set (FAS) consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, and had at least one on-treatment efficacy assessment. The treated set was analyzed for safety. The FAS was analyzed for efficacy.||SSEs||Standard Deviation|Mean
805232|NCT00996164|Primary|The Change From Baseline to Week 24 in the Score of the Female Sexual Function Index Desire Domain.|The FSFI is a self-administered questionnaire for assessing key dimensions of sexual function in women. The scale consists of 19 items assessing sexual function over the past 4 weeks and yields scores in 6 domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. The 2 items in the desire domain are scored from '1' to '5'. The raw scores of the 2 items are added together and then multiplied by the domain factor of 0.6. Thus, the score of the desire domain ranges from 1.2 to 6.0. The higher the score on the desire domain, the higher the level of reported sexual desire.|24 weeks|The Full Analysis Set (FAS) consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, and had at least one on-treatment efficacy assessment. The treated set was analyzed for safety. The FAS was analyzed for efficacy.||units on a scale||Standard Error|Mean
805233|NCT00996203|Secondary|Erythrocyte Sedimentation Rate|ESR (mm/hr) is used to determine the acute phase response.|Weeks 4, 8, 12, 16, 20, and 24|ITT Population; n=number of participants assessed at a specific visit.||mm/hr||Standard Deviation|Mean
805234|NCT00996203|Secondary|C-Reactive Protein|CRP (milligrams/Liter) is a mediator of inflammation, acute phase protein.|Weeks 4, 8, 12, 16, 20, and 24|ITT Population; n=number of participants assessed at a specific visit.||mg/L||Standard Deviation|Mean
805235|NCT00996203|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28|The DAS28-based EULAR response criteria were used to measure individual response as no effect, good effect, and moderate effect, depending on the extent of change from baseline and the level of disease activity reached. Good effect: change from baseline >1.2 with DAS28 score ≤3.2; moderate effect: change from baseline >1.2 with DAS28 score 3.2 to 5.1 or change from baseline >0.6 to <1.2 with DAS28 score <3.2; no effect: change from baseline ≤0.6 or change from baseline >0.6 and ≤1.2 with DAS28 score >5.1.|Weeks 4, 8, 12, 16, 20, and 24|ITT Population; n=number of participants assessed at a specific visit.||percentage of participants|||Number
805236|NCT00996203|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20), 50% (ACR50), and 70% (ACR70) Response|ACR20/50/70 response: ≥20%, ≥50%, or ≥70% improvement, respectively, in swollen/tender joint count (66 joints assessed for swelling and 68 joints assessed for tenderness) and in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and acute phase response: C-reactive protein (CRP) or ESR.|Weeks 0, 4, 8, 12, 16, 20, and 24|ITT Population; n=number of participants assessed at a specific visit.||percentage of participants|||Number
805237|NCT00996203|Secondary|Percentage of Patients With Varied Disease Activity Assessed Using DAS28 During Tocilizumab Treatment|DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR mm/hour, and global health assessment (participant rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. Disease activity: 0=remission (DAS28 less than [<] 2.6), I=low (DAS28 less than or equal to [≤]2.6 to <3.2), II=moderate (DAS28=3.2 to 5.1), III=high (DAS28 greater than [>]5.1).|Weeks 0, 4, 8, 12, 16, 20, and 24|ITT Population; n=number of participants assessed at a specific visit.||percentage of participants|||Number
805238|NCT00996203|Primary|Change in HAQ Score at Week 24|HAQ includes 20 questions concerning participant’s activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant’s everyday activities: 0=without difficulties; 1=with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3.|Baseline and Week 24|ITT population||units on a scale||Standard Deviation|Mean
805260|NCT00996216|Secondary|Platelet Counts at the Indicated Time Points|Blood samples were collected for the measurement of platelet count. For each participant, the duration of Part 1 treatment varies between 2 and 9 weeks.|From the start of investigational product up to the 24-week follow-up visit after the last dose in Part 2 or early withdrawal (up to 96 weeks)|Pre-antiviral Safety Population||Gi/L||Standard Deviation|Mean
810719|NCT01048606|Primary|Sex-hormone Levels. Estradiol, Estrone, Progesterone, Testosterone and SHBG Will be Obtained by Enzyme Immuno Assay (EIA)||6 months||||||
805239|NCT00996203|Primary|Percentage of Participants With an HAQ Score Decrease of 20 Percent (%), 50%, and 70% During Tocilizumab Treatment|HAQ includes 20 questions concerning participant’s activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant’s everyday activities: 0=without difficulties; 1=with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3.|Weeks 4, 8, 12, 16, 20, and 24|ITT population:||percentage of participants|||Number
805240|NCT00996203|Secondary|Change in DAS28 Score From Baseline to Week 24||Baseline and Week 24|ITT Population||units on a scale||Standard Deviation|Mean
805241|NCT00996203|Secondary|Disease Activity Score Based on 28-Joint Count (DAS28)|DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and global health assessment (participant rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity.|Weeks 0, 4, 8, 12, 16, 20, and 24|ITT Population; n=number of participants assessed at a specific visit.||units on a scale||Standard Deviation|Mean
805242|NCT00996203|Secondary|Change in General Health Assessed by VAS|Participant-reported general health quality was assessed using an EQ-5D 100-mm horizontal VAS (0 to 100 mm) with 0=worst health state and 100=the best health state. The participants were asked to mark the line that corresponded to assessment of general health quality.|Baseline and Week 24|ITT Population||mm||Standard Deviation|Mean
805243|NCT00996203|Secondary|Percentage of Participants Achieving a Positive Response on Health Quality Assessment of EQ-5D|Participant-reported general health quality was assessed using an EQ-5D 100-mm horizontal VAS (0 to 100 mm) with 0=worst health state and 100=the best health state. The participants were asked to mark the line that corresponded to assessment of general health quality. Positive response was defined as an increase of EQ-5D score by 0.1 or more i.e. it is a clinically significant increase.|Weeks 0, 4, 8, 12, 16, 20, and 24|ITT Population; n=number of participants assessed at a specific visit.||percentage of Participants|||Number
805244|NCT00996203|Secondary|General Health Score as Assessed by EQ-5D VAS|Participant-reported general health quality was assessed using an EQ-5D 100-mm horizontal VAS (0 to 100 mm) with 0=worst health state and 100=the best health state. The participants were asked to mark the line that corresponded to assessment of general health quality.|Weeks 0, 4, 8, 12, 16, 20, and 24|ITT Population; n=number of participants assessed at a specific visit.||mm||Standard Deviation|Mean
805245|NCT00996203|Secondary|Change in EQ-5D Score at Week 24 From Baseline|EQ-5D questionnaire assess 5 domains of quality of life including mobility, self-care, habitual daily activities, pain, discomfort, and anxiety/depression. Each of five domains was assessed by 3 levels depending on severity of a problem and scored using the following: 1=no disturbances, 2=moderate disturbances, 3=severe disturbances. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. Minimum clinically significant change in EQ-5D corresponds to the parameter differences before and after treatment = 0.10. Graduations of assessment of the therapy efficacy by EQ-5D are: Difference (Δ) EQ-5D less than (<)0.10 points: none; 0.10 less than or equal to (≤)Δ EQ-5D ≤0.24: minimal effect; 0.24≤ Δ EQ-5D <0.31: satisfactory effect; Δ EQ-5D greater than or equal to (≥)0.31 points: pronounced effect.|Baseline and Week 24|ITT Population||units on a scale||Standard Deviation|Mean
805246|NCT00996203|Secondary|European Quality of Life - 5 Dimensions (EQ-5D) Score|EQ-5D questionnaire assess 5 domains of quality of life including mobility, self-care, habitual daily activities, pain, discomfort, and anxiety/depression. Each of five domains was assessed by 3 levels depending on severity of a problem and scored using the following: 1=no disturbances, 2=moderate disturbances, 3=severe disturbances. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Weeks 0, 4, 8, 12, 16, 20, and 24|ITT Population; n=number of participants assessed at a specific visit.||units on a scale||Standard Deviation|Mean
805247|NCT00996203|Secondary|Pain Score as Assessed by Visual Analogue Scale (VAS)|Participant's global assessment of pain was assessed using a 100-millimeter (mm) horizontal VAS (0 to 100 mm) with 0=pain absent and 100=intolerable pain. Participants responded by placing a mark on the line to indicate their current level of pain.|Weeks 0, 4, 8, 12, 16, 20, and 24|ITT Population; n=number of participants assessed at a specific visit.||mm||Standard Deviation|Mean
805248|NCT00996203|Primary|Health Assessment Questionnaire (HAQ) Score|HAQ includes 20 questions concerning participant’s activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant’s everyday activities: 0 (equals)=without difficulties; 1=with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3. Withdrawal Visit is the final visit prior to the withdrawal of the subject from the study.|Weeks 0, 4, 8, 12, 16, 20, and 24 and Withdrawal Visit|Intent-to-Treat (ITT) population: All participants randomized in the study who received administration of at least one dose of the study drug and who had at least one efficacy assessment performed. n (number) = number of participants assessed at a specific visit.||units on a scale||Standard Deviation|Mean
805249|NCT00996216|Secondary|Number of Participants Achieving Antiviral Treatment Milestones of Sustained Virological Response (SVR), Rapid Virological Response (RVR), Early Virological Response (EVR), and End of Treatment Response (ETR)|SVR is defined as non-detectable Hepatitis C virus (HCV) ribonucleic acid (RNA) at 24 weeks post-completion of the planned treatment period (i.e., Week 48 or 72 for genotype 2/3 or Week 72 for non-genotype 2/3). RVR is defined as undetectable HCV RNA after 4 weeks of antiviral treatment. EVR is defined as clinically significant reduction in HCV RNA (>=2 log10 drop or undetectable) after 12 weeks of antiviral treatment. ETR is defined as undetectable HCV RNA at the end of antiviral treatment.|From the start of investigational product in Part 2 up to the 24-week follow-up visit after the last dose in Part 2 or early withdrawal (up to 96 weeks)|Antiviral Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Antiviral Safety Population.||Participants|||Number
810720|NCT01048606|Primary|Sex-hormone Levels. Estradiol, Estrone, Progesterone, Testosterone and SHBG Will be Obtained by Enzyme Immuno Assay (EIA)||Baseline||||||
805250|NCT00996216|Primary|Number of Participants With a logMAR Change >=0.15 During Parts 1 and 2|LogMAR (logarithm of the minimum angle of resolution) charts are used to measure an individual's visual acuity. LogMAR, expressed as the (decadic) logarithm of the minimum angle of resolution (range from +1.00 to -0.30), converts the geometric sequence of a traditional chart to a linear scale. As there are 5 letters per line, the total score for a line on the LogMAR chart represents a change of 0.1 log units.|From the start of investigational product up to the 24-week follow-up visit after the last dose in Part 2 or early withdrawal (up to 96 weeks)|Entire Safety Population||Participants|||Number
805251|NCT00996216|Primary|Number of Participants With the Indicated Change in logMAR Scale Values During Parts 1 and 2|LogMAR (logarithm of the minimum angle of resolution) charts are used to measure an individual's visual acuity. LogMAR, expressed as the (decadic) logarithm of the minimum angle of resolution (range from +1.00 to -0.30), converts the geometric sequence of a traditional chart to a linear scale. As there are 5 letters per line, the total score for a line on the LogMAR chart represents a change of 0.1 log units.|From the start of investigational product up to the 24-week follow-up visit after the last dose in Part 2 or early withdrawal (up to 96 weeks)|Entire Safety Population||Participants|||Number
805252|NCT00996216|Primary|Number of Participants With a Decrease in Visual Acuity During Parts 1 and 2|Visual acuity (VA) is defined as acuteness or clearness of vision.|From the start of investigational product up to the 24-week follow-up visit after the last dose in Part 2 or early withdrawal (up to 96 weeks)|Entire Safety Population: all participants in the Pre-antiviral Safety Population||Participants|||Number
805253|NCT00996216|Primary|Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Hematology Parameters During Part 2|Blood samples were collected for the measurement of hematology chemistry parameters. The DAIDS grades are utilized for measuring the severity of AEs. Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening.|From Day 0 of Part 2 (Antiviral Baseline Visit [between Study Day 14 and Study Day 65) to the completion of the follow-up period (up to Week 96/WD)|Antiviral Safety Population||Participants|||Number
805254|NCT00996216|Primary|Number of Participants With the Indicated Worst-case DAIDS Grade Increases From Screening for the Indicated Hematology Parameters During Part 1|Blood samples were collected for the measurement of hematology parameters. The DAIDS grades are utilized for measuring the severity of AEs. Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening.|From Screening up to the start of antiviral therapy (up to 9 weeks; median of 21 days)|Pre-antiviral Safety Population. Only participants with data available at the specified time point were analyzed.||Participants|||Number
805255|NCT00996216|Primary|Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2|Blood samples were collected for the measurement of clinical chemistry parameters. The DAIDS grades are utilized for measuring the severity of AEs. Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening.|From Day 0 of Part 2 (Antiviral Baseline Visit [between Study Day 14 and Study Day 65) to the completion of the follow-up period (up to Week 96/WD)|Antiviral Safety Population||Participants|||Number
805256|NCT00996216|Primary|Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1|Blood samples were collected for the measurement of clinical chemistry parameters. The DAIDS grades are utilized for measuring the severity of AEs. Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening.|From Screening up to the start of antiviral therapy (up to 9 weeks; median of 21 days)|Pre-antiviral Safety Population. Only participants with data available at the specified time point were analyzed.||Participants|||Number
805257|NCT00996216|Primary|Number of Participants With Any AE and Any SAE in Part 2|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs and SAEs.|From the date of initiation of antiviral therapy (Antiviral Baseline Visit [between Study Day 14 and Study Day 65]) to the completion of the follow-up period (up to Week 96/WD)|Antiviral Safety Population: all participants who entered the Antiviral Treatment Phase (Part 2) of the study and who received at least one dose of antiviral therapy||Participants|||Number
805258|NCT00996216|Primary|Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) in Part 1|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs and SAEs.|From the start of investigational product up to the start of antiviral therapy (up to 9 weeks; median of 21 days)|Pre-antiviral Safety Population: all participants who received study drug in the Pre-antiviral Treatment Phase (Part 1) of the study||Participants|||Number
805259|NCT00996216|Secondary|Number of Particpants Who Initiated Antiviral Therapy|The number of participants who completed the Pre-antiviral Phase (Part 1) and proceeded to the Antiviral Phase (Part 2) are summarized.|From the start of the investigational product up to 9 weeks (median of 21 days)|Pre-antiviral Safety Population||Participants|||Number
805272|NCT00996333|Secondary|Toxicity Assessment|Data was not analyzed because original PI left institution before data analysis was completed.|Every month||||||
805273|NCT00996333|Secondary|Determine Overall and One Year Survival Rates|Data was not analyzed because original PI left institution before data analysis was completed.|One year||||||
805274|NCT00996333|Primary|To Determine Response Rate to the GTX Regimen in Patients With Pancreatic Cancer|Data was not analyzed because original PI left institution before data analysis was completed.|10 weeks||||||
805275|NCT00996346|Primary|Maximum Tolerated Dose (MTD) of Temsirolimus|The MTD is the dose preceding that at which at least 2 out of 3 patients in the treatment group experience a dose limiting toxicity (DLT). DLT is defined as grade 3 neutropenia on retreatment day, a grade 4 febrile neutropenia, a drug-related grade 3 or 4 non-hematologic toxicity (except fatigue, nausea, vomiting or grade 3 hypersensitivity reaction) or a grade 2 or greater motor or sensory neuropathy|Up to 1 month|||milligrams|||Number
805276|NCT00996346|Primary|Maximum Tolerated Dose (MTD) of Irinotecan|The MTD is the dose preceding that at which at least 2 out of 3 patients in the treatment group experience a dose limiting toxicity (DLT). DLT is defined as grade 3 neutropenia on retreatment day, a grade 4 febrile neutropenia, a drug-related grade 3 or 4 non-hematologic toxicity (except fatigue, nausea, vomiting or grade 3 hypersensitivity reaction) or a grade 2 or greater motor or sensory neuropathy|Up to 1 month|||milligrams/meter squared|||Number
805440|NCT00996658|Secondary|Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 18 Weeks|Glycosylated hemoglobin is reported as a percentage of the total hemoglobin|baseline, 18 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline HbA1c value and an on-treatment HbA1c value. Three subjects in each arm excluded for site non-compliance.||Percentage||Standard Error|Least Squares Mean
805277|NCT00996372|Secondary|Change From Baseline on Question 13 of the Female Sexual Distress Scale Revised (FSDS R)|The FSDS© is a self-administered measure of female personal distress associated with sexual dysfunction. Question 13 inquires about distress specifically related to sexual desire. The range for each question, including Question 13, is 0 (Never) to 4 (Always).|change from baseline to 24 weeks|The full analysis set (FAS), consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, had at least one baseline value of either one of the co-primary endpoints or key secondary endpoint, and had data available. The FAS was analyzed for efficacy.||units on a scale||Standard Error|Least Squares Mean
805278|NCT00996372|Primary|Change From Baseline in the Score on the Female Sexual Function Index (FSFI) Desire Domain|The FSFI© is a brief, self-administered questionnaire to assess key dimensions of sexual function in women. The scale consists of 19 items that assess sexual function over the past four weeks and yields scores in six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. The two items in the desire domain are scored from 1 to 5 (with 1 being the lowest report of desire and 5 being the highest). The raw scores of the two items are added together and then multiplied by the domain factor of 0.6. Thus, the score of the desire domain ranges from 1.2 to 6.0 (the higher the score, the higher the reported level of desire).|baseline through 24 weeks|The full analysis set (FAS), consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, had at least one baseline value of either one of the co-primary endpoints or key secondary endpoint, and had data available. The FAS was analyzed for efficacy.||units on a scale||Standard Deviation|Mean
805279|NCT00996372|Primary|Change From Baseline in the Number of Satisfying Sexual Events|A small handheld electronic device (eDiary) was used by patients to record information about sexual events. Patients were instructed to complete the eDiary every morning. When completing an eDiary entry, patients answered questions regarding their sexual events since their last eDiary entry. If patients missed or were late with their eDiary entry, they could enter information about their sexual events since their most recent entry up to a maximum of seven days in the past.|baseline through 24 weeks|The full analysis set (FAS), consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, had at least one baseline value of either one of the co-primary endpoints or key secondary endpoint, and had data available. The FAS was analyzed for efficacy.||sexual events||Standard Deviation|Mean
805280|NCT00996437|Secondary|Very Severe Visual Acuity Loss (Defined as <20/800)||4,8 and 12 weeks|Participants with a completed 4, 8 and 12 week visit respectively and an available visual acuity measurement were included in the analysis.||percentage of participants|||Number
805281|NCT00996437|Secondary|Severe Visual Acuity Loss (Defined as <20/200)||4,8 and 12 weeks|Participant with a completed 4,8 and 12 week visit and an available visual acuity measurement were included in this analysis.||percentage of participants|||Number
805282|NCT00996437|Secondary|Visual Acuity Better Than 20/40 and no Vitrectomy Prior to the Visit||4, 8 and 12 weeks|This analysis followed the intent-to-treat principle. It includes all randomized eyes with a completed 4, 8 and 12 week visit respectively and an available visual acuity measure.||percentage of participants|||Number
805283|NCT00996437|Secondary|Visual Acuity Adjusted for the Baseline Acuity Regardless of Vitrectomy Status|Visual acuity was analyzed using a longitudinal mixed regression model adjusting for baseline visual acuity.Unit of measure is based on the E-ETDRS visual acuity letter score scale, 0-97, where 0 = worst and 97 = best.|4, 8 and 12 weeks|Number of participants with a complete 4 week visit, 8 and 12 week respectively and an available visual acuity measurement.||letter scores||Standard Deviation|Mean
805284|NCT00996437|Secondary|Extent of Vitreous Hemorrhage Measured by Optical Coherence Tomography Signal Strength|Optical coherence tomography signal strength was evaluated as a potential indicator of vitreous hemorrhage density in an exploratory analysis. This analysis included only eyes with Optical Coherence Tomography (OCT) signal strength equals to 0 at baseline.|4, 8 and 12 weeks|This analysis followed the intent-to-treat principle||percentage of eyes|||Number
805285|NCT00996437|Secondary|Ability to Complete Panretinal Photocoagulation (PRP) in the Absence of Vitrectomy|"The proportion of eyes with complete panretinal photocoagulation by 16 weeks in abscence of vitrectomy was computed using the life-table method and treatment groups were compared using the log-rank test."|within 112 days of randomization|The secondary analysis followed the intent-to-treat principle and included all randomized eyes.||percentage of eyes|||Number
805286|NCT00996437|Primary|Safety (Injected-related, Ocular Drug-related and Systemic Drug-related)||Baseline to 16 weeks|Adverse events for each participants was collected throughout study duration.||participants|||Number
805287|NCT00996437|Primary|"Treatment or Failure Defined as Vitrectomy"|The cumulative probabilities of vitrectomy by 16 weks (112 days) in each group were computed using the life-table method. The treatment group comparison was made using the log-rank test. Data were censored at the time point of the participant's last completed visit.|within 112 days of randomization|The primary analysis followed the intent-to-treat principle and included all randomized eyes.||percentage of participants|||Number
805288|NCT00996476|Primary|The Number of Participants Who Met Virologic Stopping/Continuation Rules and Completed All Study Medications|"The table below shows the number of participants who met response-guided treatment (RGT) stopping criteria in the TMC435 treatment groups. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels less than 1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20 were to stop all study medication (TMC435, PegIFNα-2a, and ribavirin) at Week 24. All other participants continued PegIFNα-2a and ribavirin until Week 48. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Week 24|The efficacy analyses were based on the per protocol set (PPS) of participants and consisted of a subset of participants in the full analysis set (FAS) which had no major protocol violations suspected to influence efficacy assessment and had data available at the time point(s) analyzed.||Participants|||Number
805307|NCT00996580|Primary|Summary of Participants With Treatment-emergent Adverse Events|"The on-treatment time frame spanned the time during which study drug was administered until 3 weeks beyond the last study drug date.
Relationship to study drug was assessed by the investigator.
Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention."|Day 1 up to 13 months|Safety population of treated participants||participants|||Number
805289|NCT00996476|Primary|Time to Reach the Maximum Plasma Concentration (Tmax) of TMC435|"The table below shows the median time in hours to reach the maximum plasma concentration (tmax) of TMC435 for participants in the 2 TMC435 50 mg treatment groups combined (TMC12/PR24 50 mg and TMC24/PR24 50 mg) and for participants in the 2 TMC435 100 mg treatment groups combined (TMC12/PR24 100 mg and TMC24/PR24 100 mg) who had intensive blood samples collected at Weeks 4 to 6. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|within 15 minutes and at 1, 2, 4, 6, 8, 12, and 24 hours post-dose between Week 4 and Week 6 after the initiation of treatment|Pharmacokinetic (PK) analysis was performed in the PK population defined as all participants from whom intensive blood samples were drawn and who received at least 1 dose of study medication.||Hours||Full Range|Median
805290|NCT00996476|Primary|The Area Under the Plasma Concentration-time Curve From the Time of Administration up to 24 Hours After Dosing (AUC24) for TMC435|"The table below shows the mean AUC24 of TMC435 for participants in the 2 TMC435 50 mg treatment groups combined (TMC12/PR24 50 mg and TMC24/PR24 50 mg) and for participants in the 2 TMC435 100 mg treatment groups combined (TMC12/PR24 100 mg and TMC24/PR24 100 mg) who had intensive blood samples collected at Weeks 4 to 6. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|within 15 minutes and at 1, 2, 4, 6, 8, 12, and 24 hours post-dose between Week 4 and Week 6 after the initiation of treatment|Pharmacokinetic (PK) analysis was performed in the PK population defined as all participants from whom intensive blood samples were drawn and who received at least 1 dose of study medication.||ng∙h/mL||Standard Deviation|Mean
805291|NCT00996476|Primary|Predose Plasma Concentrations (C0h) of TMC435 (Intensive Blood Sampling)|"The table below shows the mean predose plasma concentration (C0h) for participants in the 2 TMC435 50 mg treatment groups combined and for participants in the 2 TMC435 100 mg treatment groups combined who had intensive blood samples collected at Weeks 4 to 6. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Weeks 4 to 6|Pharmacokinetic (PK) analysis was performed in the PK population defined as all participants from whom intensive blood samples were drawn and who received at least 1 dose of study medication.||ng/mL||Standard Deviation|Mean
805292|NCT00996476|Primary|Predose Plasma Concentrations (C0h) of TMC435 (Sparse Blood Sampling)|"The table below shows the mean (standard deviation) predose plasma concentration (C0h) for participants in each treatment group at Weeks 4, 12, and 24. The number of participants analyzed is listed at each time point in order of the treatment groups from left to right in the table (ie, Week x, n=x, x, x, x, and x) if different from the “Number of Participants Analyzed. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Weeks 4, 12, and 24|Pharmacokinetic (PK) analysis was performed in the PK population defined as all participants from whom sparse blood samples were drawn and who received at least 1 dose of study medication.||ng/mL||Standard Deviation|Mean
805293|NCT00996476|Primary|The Percentage of Participants With Sustained Virologic Response (SVR)|"The table below shows the percentage of participants with a SVR4, SVR12, and SVR24 defined as undetectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) at the end of treatment (EOT) (up to Weeks 24 or 48) and at 4, 12, and 24 weeks, respectively, after the last dose of treatment. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|SVR4 (up to Week 28 or Week 52), SVR12 (up to Weeks 36 or 60), and SVR24 (up to Weeks 48 or 72)|The efficacy analyses were based on the per protocol set (PPS) of participants and consisted of a subset of participants in the full analysis set (FAS) which had no major protocol violations suspected to influence efficacy assessment and had data available at the time point(s) analyzed.||Percentage of participants|||Number
805294|NCT00996476|Primary|The Number of Participants With Alanine Aminotransaminase (ALT) Values Within the Normal Range at the End-of-treatment (EOT)|"The table below shows the number of participants whose ALT results were within the normal range on Day 1 (initial day of treatment), Week 24, 48, and EOT (up to Weeks 24 or 48).The number of participants analyzed is listed at each time point in order of the treatment groups from left to right in the table (ie, Week x, n=x, x, x, x, and x) if different from the “Number of Participants Analyzed. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Day 1, Weeks 24, 48, and EOT (up to Weeks 24 or 48)|The efficacy analyses were based on the per protocol set (PPS) of participants and consisted of a subset of participants in the full analysis set (FAS) which had no major protocol violations suspected to influence efficacy assessment and had data available at the time point(s) analyzed.||Participants|||Number
805295|NCT00996476|Primary|Actual Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values up to Week 24 in the Post-treatment Follow-up Period|"The table below shows the mean (standard deviation) of the actual HCV RNA values by treatment group at Baseline and Weeks 4, 12, 24, 48, end of treatment (EOT, up to Weeks 24 or 48), Weeks 60 and 72 (Week 24 in the post-treatment follow-up period). The number of participants analyzed is listed at each time point in order of the treatment groups from left to right in the table (ie, Week x, n=x, x, x, x, and x) if different from the “Number of Participants Analyzed. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Baseline, Week 4, 12, 24, 48, EOT (up to Week 24 or 48), and Weeks 60 and 72|Efficacy analyses were based on the per protocol set (PPS) of participants and consisted of a subset of participants in the full analysis set (FAS) which had no major protocol violations suspected to influence efficacy assessment and had data available at the time point(s) analyzed.||log10 IU/mL||Standard Deviation|Mean
805296|NCT00996476|Primary|The Percentage of Participants With Viral Relapse|"The table below shows the percentage of participants in each treatment group who experienced viral relapse within 12 weeks (ie, at Week 36 or 60) after actual end of treatment (EOT) (up to Week 24 or 48). Viral relapse was defined as confirmed detectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels during the post treatment follow-up period at Weeks 36 or 60 in participants with undetectable plasma HCV RNA at EOT. The statistical analysis shows the difference in treatments (ie, each TMC435 group minus PR48 control) in viral relapse. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Week 36 or 60|The efficacy analyses were based on the per protocol set (PPS) of participants and consisted of a subset of participants in the full analysis set (FAS) which had no major protocol violations suspected to influence efficacy assessment and had data available at the time point(s) analyzed.||Participants|||Number
805297|NCT00996476|Primary|The Number of Participants With Viral Breakthrough|"The table below shows the number of participants in each treatment group who experienced viral breakthrough during the 48 week treatment period with at least one study medication (TMC435 or PegIFNα-2a and ribavirin). Viral breakthrough is defined as a confirmed increase of greater than (>) 1 log10 IU/mL in plasma hepatitis C virus (HCV) ribonucleic acid (RNA) level from the lowest level reached or a confirmed value of plasma HCV RNA of > 2.0 log10 IU/mL in participants whose plasma HCV RNA level had previously been reported below 1.2 log10 IU/mL detectable or undetectable during the treatment period. The number of participants analyzed is listed at each time point in order of the treatment groups from left to right in the table (ie, Week x, n=x, x, x, x, and x) if different from the “Number of Participants Analyzed. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Up to EOT (up to Week 24 or 48)|The efficacy analyses were based on the per protocol set (PPS) of participants and consisted of a subset of participants in the full analysis set (FAS) which had no major protocol violations suspected to influence efficacy assessment and had data available at the time point(s) analyzed.||Participants|||Number
805298|NCT00996476|Primary|The Percentage of Participants With Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels Undetectable or Below the Limit of Quantification (<1.2 log10 IU/mL Detectable) During Treatment and During Post Treatment Follow-up|"The table below shows the percentage of participants in each treatment group with plasma HCV RNA levels undetectable or below the limit of quantification (<1.2 log10 IU/mL detectable ) at time points during treatment and post treatment follow-up.The number of participants analyzed is listed at each time point in order of the treatment groups from left to right in the table (ie, Week x, n=x, x, x, x, and x) if different from the “Number of Participants Analyzed. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Week 4, 12, 24, 36, 48, EOT (up to Week 24 or 48), and Week 60 and 72|Efficacy analyses were based on the per protocol set (PPS) of participants and consisted of a subset of participants in the full analysis set (FAS) which had no major protocol violations suspected to influence efficacy assessment and had data available at the time point(s) analyzed.||Percentage of participants|||Number
805299|NCT00996476|Primary|The Percentage of Participants With a Decrease of Greater Than or Equal to 2 log10 IU/mL From Baseline in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Through the Post-treatment Follow-up Period|"The table below shows the percentage of participants in each treatment group with a decrease of greater than (>) or equal (=) to 2 log10 IU/mL from baseline in plasma HCV RNA levels at time points during the treatment period and post treatment follow-up period. The number of participants analyzed is listed at each time point in order of the treatment groups from left to right in the table (ie, Week x, n=x, x, x, x, and x) if different from the “Number of Participants Analyzed. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Days 1 (4 hr), 1 (8 hr), 3, Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, 24,28, 36, 42, 48, 52, 60, 72, and EOT (up to Week 24 or 48)|Efficacy analyses were based on the per protocol set (PPS) of participants and consisted of a subset of participants in the full analysis set (FAS) which had no major protocol violations suspected to influence efficacy assessment and had data available at the time point(s) analyzed.||Percentage of participants|||Number
805300|NCT00996476|Primary|The Percentage of Participants With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels During the Study|"The table below shows the percentage of participants in each treatment group with undetectable plasma HCV RNA levels at Weeks 4, 12, 24, 48, and end of treatment (EOT, up to Week 24 or 48). The number of participants analyzed is listed at each time point in order of the treatment groups from left to right in the table (ie, Week x, n=x, x, x, x, and x) if different from the “Number of Participants Analyzed.NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Weeks 4, 12, 24 or 48, and EOT (up to Week 24 or 48)|Efficacy analyses were based on the per protocol set (PPS) of participants and consisted of a subset of participants in the full analysis set (FAS) which had no major protocol violations suspected to influence efficacy assessment and had data available at the time point(s) analyzed.||Percentage of participants|||Number
805301|NCT00996476|Primary|Change in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels From Baseline to Week 4|"The table below shows the least-squares (LS) mean change and 95% confidence intervals (CI) change from baseline at Week 4 in HCV RNA levels for participants in the 2 TMC435 50 mg treatment groups combined (TMC12/PR24 50 mg and TMC24/PR24 50 mg) and for participants in the 2 TMC435 100 mg treatment groups combined (TMC12/PR24 100 mg and TMC24/PR24 100 mg). The statistical analyses show the difference in LS mean change from baseline from the PR48 control group and the 95% CI for each dose group (ie, each TMC435 dose group minus PR48 control). NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Day 1 (Baseline) and Week 4|The efficacy analyses were based on the per protocol set (PPS) of participants and consisted of a subset of participants in the full analysis set (FAS) which had no major protocol violations suspected to influence efficacy assessment and had data available at the time point(s) analyzed.||log10 IU/mL||95% Confidence Interval|Least Squares Mean
805302|NCT00996502|Secondary|Proportion of Patients Alive at One Year (Phase II)||One year||||||
805303|NCT00996502|Secondary|Overall Survival Rate||2 years||||||
805304|NCT00996502|Secondary|Objective Response Rate at the Recommended Phase II Dose Level of Docetaxel, Bevacizumab, Erlotinib, and Prednisone||Every 9 weeks||||||
805305|NCT00996502|Primary|Maximum Tolerated Dose of Docetaxel in Combination With Erlotinib, Bevacizumab, and Prednisone (Phase I)||After three 21-day cycles|The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in March 2010.|||||
805306|NCT00996580|Secondary|Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 91-day Cycles and Broken Out by Subpopulations Defined by Participant Weight|A life table approach was used to estimate the cumulative pregnancy rate on a cycle-by-cycle basis for each of the four 91-day treatment cycles.|Day 1 up to year 1|'Compliant-Use' set included PITT participants who completed at least one 91-day cycle and no other birth control methods were used. Cycles were excluded if a subject 1) skipped 2 or more consecutive combination pills, 2) had a pattern of substantial non-compliance with treatment, or 3) used a prohibited concomitant medication||pregnancies / cumulative exposure||95% Confidence Interval|Number
805308|NCT00996580|Primary|Compliant-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycle-Equivalents and Broken Out by Subpopulations Defined by Participant Weight|"Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-103 or > 7 days after stopping the combination EE/LNG treatment of DR-103. The estimated date of conception and gestational age of the fetus was determined by transvaginal or abdominal ultrasound.
In order to compare the efficacy of extended treatment with DR-103 to conventional 28-day cyclic oral contraceptive treatment, the 91-day DR-103 treatment cycle was separated into three 28-day cycle-equivalents, derived from the 84-day active combination (EE/LNG) pill period of each 91-day extended cycle.
The PI is defined as number of contraceptive failures per 100 women-years of exposure:
(100)*(total number of pregnancies)*(13)/(total number of 28-day cycles)"|Day 1 up to year 1|'Compliant-Use' set included PITT participants who completed at least one 28-day cycle and no other birth control methods were used. Cycles were excluded if a subject 1) skipped 2 or more consecutive combination pills, 2) had a pattern of substantial non-compliance with treatment, or 3) used a prohibited concomitant medication||pregnancies / 100 woman years exposure||95% Confidence Interval|Number
805309|NCT00996580|Primary|Typical-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycle-Equivalents and Broken Out by Subpopulations Defined by Participant Weight|"Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-103 or > 7 days after stopping the combination EE/LNG treatment of DR-103. The estimated date of conception and gestational age of the fetus was determined by transvaginal or abdominal ultrasound.
In order to compare the efficacy of extended treatment with DR-103 to conventional 28-day cyclic oral contraceptive treatment, the 91-day DR-103 treatment cycle was separated into three 28-day cycle-equivalents, derived from the 84-day active combination (EE/LNG) pill period of each 91-day extended cycle.
The PI is defined as number of contraceptive failures per 100 women-years of exposure:
(100)*(total number of pregnancies)*(13)/(total number of 28-day cycles)"|Day 1 up to year 1|Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age when study treatment started. The 'Typical-Use' set included PITT participants who completed at least one 28-day cycle and no other birth control methods including condoms were used.||pregnancies / 100 woman years exposure||95% Confidence Interval|Number
805310|NCT00996580|Primary|All Users Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycle-Equivalents and Broken Out by Subpopulations Defined by Participant Weight|"Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-103 or > 7 days after stopping the combination EE/LNG treatment of DR-103. The estimated date of conception and gestational age of the fetus was determined by transvaginal or abdominal ultrasound.
In order to compare the efficacy of extended treatment with DR-103 to conventional 28-day cyclic oral contraceptive treatment, the 91-day DR-103 treatment cycle was separated into three 28-day cycle-equivalents, derived from the 84-day active combination (EE/LNG) pill period of each 91-day extended cycle.
The PI is defined as number of contraceptive failures per 100 women-years of exposure:
(100)*(total number of pregnancies)*(13)/(total number of 28-day cycles)"|Day 1 up to year 1|Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age when study treatment started. The 'All Users' set included PITT participants who completed at least one 28-day cycle.||pregnancies / 100 woman years exposure|Participants|95% Confidence Interval|Number
805311|NCT00996580|Secondary|All Users Life-Table Estimates of Pregnancy Rates Based on 91-day Cycles and Broken Out by Subpopulations Defined by Participant Weight|A life table approach was used to estimate the cumulative pregnancy rate on a cycle-by-cycle basis for each of the four 91-day treatment cycles.|Day 1 up to year 1|Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age when study treatment started. The 'All Users' set included PITT participants who completed at least one 91-day cycle.||pregnancies / cumulative exposure||95% Confidence Interval|Number
805312|NCT00996580|Primary|Compliant-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 91-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight|"Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-103 or > 7 days after stopping the combination EE/LNG treatment of DR-103. The estimated date of conception and gestational age of the fetus was determined by transvaginal or abdominal ultrasound.
The PI is defined as number of contraceptive failures per 100 women-years of exposure:
(100)*(total number of pregnancies)*(4)/(total number of 91-day cycles)"|Day 1 up to year 1|'Compliant-Use' set included PITT participants who completed at least one 91-day cycle and no other birth control methods were used. Cycles were excluded if a subject 1) skipped 2 or more consecutive combination pills, 2) had a pattern of substantial non-compliance with treatment, or 3) used a prohibited concomitant medication||pregnancies / 100 woman years exposure||95% Confidence Interval|Number
805313|NCT00996580|Primary|Typical-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 91-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight|"Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-103 or > 7 days after stopping the combination EE/LNG treatment of DR-103. The estimated date of conception and gestational age of the fetus was determined by transvaginal or abdominal ultrasound.
The PI is defined as number of contraceptive failures per 100 women-years of exposure:
(100)*(total number of pregnancies)*(4)/(total number of 91-day cycles)"|Day 1 up to year 1|Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age when study treatment started. The 'Typical-Use' set included PITT participants who completed at least one 91-day cycle and no other birth control methods including condoms were used.||pregnancies / 100 woman years exposure||95% Confidence Interval|Number
805357|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in IL-17 Level|Level of IL-17 was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||pg/mL||Standard Deviation|Mean
805314|NCT00996580|Primary|All Users Pregnancy Rates Based on Pearl Index (PI) Analyses for 91-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight|"Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-103 or > 7 days after stopping the combination EE/LNG treatment of DR-103. The estimated date of conception and gestational age of the fetus was determined by transvaginal or abdominal ultrasound.
The PI is defined as number of contraceptive failures per 100 women-years of exposure:
(100)*(total number of pregnancies)*(4)/(total number of 91-day cycles)"|Day 1 up to year 1|Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age when study treatment started. The 'All Users' set included PITT participants who completed at least one 91-day cycle.||pregnancies / 100 woman years exposure|Participants|95% Confidence Interval|Number
805315|NCT00996593|Primary|Overall Survival|Overall survival is defined as the time from the treatment start date to the date of death from any cause.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population. Only those participants who died during the study and during the follow-up period were analyzed.||months||95% Confidence Interval|Median
805316|NCT00996593|Secondary|Duration of the Indicated Grade 3 or Grade 4 Hematologic Toxicities|Adverse events were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No adverse event or within normal limits; 1 = Mild adverse event; 2 = Moderate adverse event; 3 = Severe and undesirable adverse event; 4 = Life-threatening or disabling adverse event; 5 = Death related to adverse event.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population. All participants with Grade 3 or Grade 4 hematologic toxicities were analyzed.||days||Full Range|Median
805317|NCT00996593|Secondary|Number of Participants With the Indicated Grade 3 or Grade 4 Hematologic Toxicities|Adverse events were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No adverse event or within normal limits; 1 = Mild adverse event; 2 = Moderate adverse event; 3 = Severe and undesirable adverse event; 4 = Life-threatening or disabling adverse event; 5 = Death related to adverse event.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population||participants|||Number
805318|NCT00996593|Secondary|Nadir Values for Hematologic Parameters Platelets and WBC Count|Nadir is defined as the lowest laboratory value recorded following the administration of study medication. Platelets and WBCs are types of blood cells.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population||cells/microliter||Full Range|Median
805319|NCT00996593|Secondary|Nadir Values for Hemoglobin, a Hematologic Parameter|Nadir is defined as the lowest laboratory value recorded following the administration of study medication. Hemoglobin is the iron-containing oxygen-transport metalloprotein in the red blood cells.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population||G/dL||Full Range|Median
805320|NCT00996593|Secondary|Nadir Values for ANC, a Hematologic Parameter|Nadir is defined as the lowest laboratory value recorded following the administration of study medication. ANC is a measure of the number of neutrophil granulocytes present in the blood. Neutrophils are a type of white blood cell that fights against infection.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population||cells/millimeters cubed (mm^3)||Full Range|Median
805321|NCT00996593|Secondary|Time to Nadir and Time to Recovery to Baseline in Hematologic Laboratory Evaluations|Nadir is defined as the lowest laboratory value recorded following the administration of the study medication. Time to recovery to baseline in hematologic laboratory evaluations is the time required for recovery from nadir values to baseline values.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population||days||Full Range|Median
805322|NCT00996593|Secondary|Number of Participants With Serious Adverse Events (SAE) Related to Study Drug|An SAE is any event occurring at any dose that results in any of the following: death, a life-threatening adverse drug experience (ADE; at immediate risk of death from the experience as it occurred), inpatient hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, or a congenital anomaly/birth defect. Medical events that may not result in death, be life-threatening, or require hospitalization may be considered to be a serious ADEs when based upon appropriate medical judgment. Relatedness was based on the investigator's medical judgement.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population. All participants who experienced any SAE were analyzed.||participants|||Number
805323|NCT00996593|Secondary|Number of Participants With an Infection for Which Anti-infectives Were Administered|Anti-infectives are capable of acting against infection, by inhibiting the spread of an infectious agent or by killing the infectious agent outright. Anti-infective is a general term that encompasses antibacterials, antibiotics, antifungals, antiprotozoans, and antivirals.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population. Only those participants who had infection during the study and during the follow-up period were analyzed.||participants|||Number
805324|NCT00996593|Secondary|Number of Participants With the Indicated Type of Infection|An infection is the colonization of a host organism by a parasite species. Infecting parasites seek to use the host's resources to reproduce, often resulting in disease. Specimen samples of the body fluid are cultured for testing whether the infectious organism is present and grown in the culture media to assess the growth pattern of the organisms present in the specimen. The culture results could be positive or negative. The positive culture results indicate that the tested participant has the infection under investigation, in which case therapeutic treatment with anti-infective is required.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population||participants|||Number
805325|NCT00996593|Secondary|Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The Investigator assessed whether the adverse event was possibly or probably related to study drug. In addition, all laboratory-derived hematologic toxicities were assumed to be possibly or probably related to study drug.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population||participants|||Number
805326|NCT00996593|Primary|Time to Progression of Disease or Death in All Responders, Participants With CR + CCR, and Participants With PR as Assessed by the Investigator|Progression-free survival or time to progression is defined as the time from the dosimetric dose to the first documented occurrence of disease progression or death.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population. Only those participants who experienced progression were evaluated.||months||95% Confidence Interval|Median
805327|NCT00996593|Primary|Progression-free Survival for Participants With or Without a Prior Response to Rituximab|Progression-free survival is defined as the time from treatment start to the first documented occurrence of disease progression or death.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|Subset of ITT Exposed Population. Only those participants who had received rituximab prior to entry into this study were evaluated. Only those participants with confirmed response were analyzed.||months||95% Confidence Interval|Median
805328|NCT00996593|Primary|Duration of Response for All Participants With CR With or Without a Prior Response to Rituximab|Duration of response is defined as the time from the first documented response to disease progression.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|Subset of ITT Exposed Population. Only those participants who had received rituximab prior to entry into this study were evaluated. Only those participants with confirmed response were analyzed.||months||95% Confidence Interval|Median
805329|NCT00996593|Primary|Number of Participants With or Without (w/o) a Prior Response to Rituximab (Before Entry Into This Study) Who Were Classified as Having a Complete Response (CR) in This Study|CR is defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|Subset of ITT Exposed Population. Only those participants who had received rituximab prior to entry into this study were evaluated.||participants|||Number
805330|NCT00996593|Primary|Duration of Response for All Participants Classified as Responders With or Without a Prior Response to Rituximab|Duration of response is defined as the time from the first documented response to disease progression.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|Subset of ITT Exposed Population. Only those participants who had received rituximab prior to entry into this study were evaluated. Only those participants with a response were analyzed.||months||95% Confidence Interval|Median
805331|NCT00996593|Primary|Number of Participants With or Without (w/o) a Prior Response to Rituximab (Before Entry Into This Study) Who Were Classified as Responders in This Study|Response corresponds to the best response evaluation (ordered by CR, CCR, and PR) and does not require subsequent confirmation. Participants with CR, CCR, or PR are considered to be responders. A prior response to rituximab refers to a CR, CCR, or PR after rituximab treatment before enrollment into Study BEX104507.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|Subset of ITT Exposed Population. Only those participants who had received rituximab prior to entry into this study were evaluated.||participants|||Number
805332|NCT00996593|Primary|Duration of Response for All Confirmed Partial Responders as Assessed by the Investigator|Response duration is defined as the time from the first documented response until progressive disease.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population. Only those participants with confirmed PR and those who experienced progressive disease were analyzed.||months||95% Confidence Interval|Median
805333|NCT00996593|Primary|Duration of Response for CR and CCR as Assessed by the Investigator|Response duration is defined as the time from the first documented response until disease progression.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population. Only those participants with confirmed CR + CCR response and those who experienced progressive disease were analyzed.||months||95% Confidence Interval|Median
805334|NCT00996593|Primary|Duration of Response for Confirmed CR as Assessed by the Investigator|Response duration is defined as the time from the first documented response until disease progression. Disease progression is defined as a >=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measureable lesions or the appearance of any new lesion. Individual lesions must be >2 centimeters (cm) in diameter by radiographic evaluation or >1 cm in diameter by physical examination.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population. Only those participants with confirmed CR and those who experienced progressive disease were analyzed.||months||95% Confidence Interval|Median
805335|NCT00996593|Primary|Duration of Response for All Confirmed Responders (CR, CCR, or PR) as Assessed by the Investigator|Response duration is defined as the time from the first documented response until disease progression.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population. Only those participants with confirmed response and those who experienced progressive disease were analyzed.||months||95% Confidence Interval|Median
805441|NCT00996658|Secondary|Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 12 Weeks|Glycosylated hemoglobin is reported as a percentage of the total hemoglobin|baseline, 12 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline HbA1c value and an on-treatment HbA1c value. Three subjects in each arm excluded for site non-compliance.||Percentage||Standard Error|Least Squares Mean
805336|NCT00996593|Primary|Number of Participants With Confirmed Partial Response (PR) as Assessed by the Investigator|Confirmed PR is defined as a >=50 percent reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions, with no new lesions.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population. Only those participants evaluable for confirmed PR were analyzed.||participants|||Number
805337|NCT00996593|Primary|Number of Participants With Confirmed Complete Response Plus Clinical Complete Response (CR + CCR) as Assessed by the Investigator|CCR is defined as the complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present. Generally, an unchanging lesion =<2 centimeters (cm) in diameter by radiographic evaluation or =<1 cm in diameter by physical examination can be considered scar tissue. The extent of disease must be unchanged or decreased upon follow-up evaluations. If the extent of disease was unchanged or if further decreases occurred for 6 months or longer, the participant was reclassified as having a CR.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population. Only those participants evaluable for CR + CCR were analyzed.||participants|||Number
805338|NCT00996593|Primary|Number of Participants With Confirmed Complete Response (CR) as Assessed by the Investigator|CR is defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population. Only those participants evaluable for confirmed response were analyzed.||participants|||Number
805339|NCT00996593|Primary|Number of Participants (Par.) With Confirmed Response as Assessed by the Investigator|Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Par. with confirmed response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|Intent-to-Treat (ITT) Exposed Population: all participants who were enrolled into the study and received at least one dose of study drug. Only those participants evaluable for confirmed response were analyzed.||participants|||Number
805340|NCT00996606|Secondary|Change From Baseline to Week 48 in Ntotal×ME by DYNAMIKA Software Analysis|Ntotal and ME were approximated using DYNAMIKA software. The sum of three different slices was used in the determination of Ntotal. The mean of three different slices was used in the determination of ME. Each slice consisted of a 2D sequence of images acquired from the same physical location at different time instances. Function of NtotalME was expressed as voxels times ratio of signal intensity before and after contrast injection (v*ratio). Baseline AV and change from Baseline to Week 48 were averaged among all participants.|Baseline and Week 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||v*ratio||Standard Deviation|Mean
805341|NCT00996606|Secondary|Change From Baseline to Week 48 in Ntotal×IRE by DYNAMIKA Software Analysis|Ntotal and IRE were approximated using DYNAMIKA software. The sum of three different slices was used in the determination of Ntotal. The mean of three different slices was used in the determination of IRE. Each slice consisted of a 2D sequence of images acquired from the same physical location at different time instances. Function of Ntotal×IRE was expressed as voxels times change in relative intensity per second (v*ΔI/sec). Baseline AV and change from Baseline to Week 48 were averaged among all participants.|Baseline and Week 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||v*ΔI/sec||Standard Deviation|Mean
805342|NCT00996606|Secondary|Change From Baseline to Week 48 in Number of Washout Enhancing Voxels (Nwashout) by DYNAMIKA Software Analysis|Nwashout was approximated using DYNAMIKA software. The sum of three different slices was used in the determination of Nwashout. Each slice consisted of a 2D sequence of images acquired from the same physical location at different time instances. Baseline AV and change from Baseline to Week 48 were averaged among all participants.|Baseline and Week 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||washout enhancing voxels||Standard Deviation|Mean
805343|NCT00996606|Secondary|Change From Baseline to Week 48 in Number of Plateau Enhancing Voxels (Nplateau) by DYNAMIKA Software Analysis|Nplateau was approximated using DYNAMIKA software. The sum of three different slices was used in the determination of Nplateau. Each slice consisted of a 2D sequence of images acquired from the same physical location at different time instances. Baseline AV and change from Baseline to Week 48 were averaged among all participants.|Baseline and Week 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||plateau enhancing voxels||Standard Deviation|Mean
805344|NCT00996606|Secondary|Change From Baseline to Week 48 in Number of Persistent Enhancing Voxels (Npersistent) by DYNAMIKA Software Analysis|Npersistent was approximated using DYNAMIKA software. The sum of three different slices was used in the determination of Npersistent. Each slice consisted of a 2D sequence of images acquired from the same physical location at different time instances. Baseline AV and change from Baseline to Week 48 were averaged among all participants.|Baseline and Week 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||persistent enhancing voxels||Standard Deviation|Mean
805529|NCT01004159|Primary|12-week Progression Free Survival Rate Upon Escalation of Cetuximab Dose to 500mg/m2 in Combination With Irinotecan After Progression on Standard Dose Therapy in Patients With KRS Wild Type Colorectal Cancer||12 week|All treated and eligible patients||percentage of participants||95% Confidence Interval|Number
805345|NCT00996606|Secondary|Change From Baseline to Week 48 in Number of Enhancing Voxels (Ntotal) by DYNAMIKA Software Analysis|Ntotal was approximated using DYNAMIKA software. The sum of three different slices was used in the determination of Ntotal. Each slice consisted of a 2D sequence of images acquired from the same physical location at different time instances. Baseline AV and change from Baseline to Week 48 were averaged among all participants.|Baseline and Week 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||enhancing voxels||Standard Deviation|Mean
805346|NCT00996606|Secondary|Change From Baseline to Week 48 in Maximum Enhancement (ME) by DYNAMIKA Software Analysis|ME was approximated by parametric mapping via DYNAMIKA software and expressed as ratio of signal enhancement before and after contrast injection. The mean of three different slices was used in the determination of ME. Each slice consisted of a 2D sequence of images acquired from the same physical location at different time instances. Baseline AV and change from Baseline to Week 48 were averaged among all participants.|Baseline and Week 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||ratio||Standard Deviation|Mean
805347|NCT00996606|Secondary|Change From Baseline to Week 48 in Initial Rate of Enhancement (IRE) by DYNAMIKA Software Analysis|IRE was approximated by parametric mapping via DYNAMIKA software and expressed as change in relative signal intensity per second (ΔI/sec). The mean of three different slices was used in the determination of IRE. Each slice consisted of a two-dimensional (2D) sequence of images acquired from the same physical location at different time instances. Baseline AV and change from Baseline to Week 48 were averaged among all participants.|Baseline and Week 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||ΔI/sec||Standard Deviation|Mean
805348|NCT00996606|Secondary|Change From Baseline to Day 2 and Weeks 2 and 4 in Soluble Transferrin Receptor (STR) Concentration|Level of STR was measured in pg/mL. Baseline AV and changes from Baseline to Day 2 and Weeks 2 and 4 were averaged among all participants.|Baseline; Day 2; and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||pg/mL||Standard Deviation|Mean
805349|NCT00996606|Secondary|Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Hemoglobin (Hb) Concentration|Level of Hb was measured in grams per liter (g/L). Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants.|Baseline and Weeks 2, 4, 12, 24, 48|ITT Population. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.||g/L||Standard Deviation|Mean
805350|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Type II Collagen Helical Peptide (HELIX-II) Level|Level of HELIX-II was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||pg/mL||Standard Deviation|Mean
805351|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Type II Collagen N-Propeptide (PIIANP) Level|Level of PIIANP was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||pg/mL||Standard Deviation|Mean
805352|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Type I Collagen C-Terminal Telopeptide (ICTP) Level|Level of ICTP was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||pg/mL||Standard Deviation|Mean
805353|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in C-Terminal Telopeptide (CTX)-1 Level|Level of CTX-1 was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||pg/mL||Standard Deviation|Mean
805354|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Type I Collagen N-Propeptide Level|Level of Type I collagen N-propeptide was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||pg/mL||Standard Deviation|Mean
805355|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Osteocalcin Level|Level of osteocalcin was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||pg/mL||Standard Deviation|Mean
805356|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Monocyte Chemoattractant Protein (MCaP)-1 Level|Level of MCaP-1 was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||pg/mL||Standard Deviation|Mean
805442|NCT00996658|Secondary|Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 6 Weeks|Glycosylated hemoglobin is reported as a percentage of the total hemoglobin|baseline, 6 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline HbA1c value and an on-treatment HbA1c value. Three subjects in each arm excluded for site non-compliance.||Percentage||Standard Error|Least Squares Mean
805358|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in IL-1β Level|Level of IL-1β was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||pg/mL||Standard Deviation|Mean
805359|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Tumor Necrosis Factor (TNF)-α Level|Level of TNF-α was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||pg/mL||Standard Deviation|Mean
805360|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in A Proliferation-Inducing Ligand (APRIL) Level|Level of APRIL was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||pg/mL||Standard Deviation|Mean
805361|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in B Cell-Activating Factor (BAFF) Level|Level of BAFF was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||pg/mL||Standard Deviation|Mean
805362|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Stromal Cell-Derived Factor (SDF) 1 Level|Level of SDF1 was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||pg/mL||Standard Deviation|Mean
805363|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in B Cell-Attracting Chemokine (BCA) Level|Level of BCA was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||pg/mL||Standard Deviation|Mean
805364|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Th17CCL17 Level|Level of Th17CCL20 was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||pg/mL||Standard Deviation|Mean
805365|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Th17 Cysteine-Cysteine Chemokine Ligand (CCL) 20 Level|Level of Th17CCL20 was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||pg/mL||Standard Deviation|Mean
805366|NCT00996606|Secondary|Change From Baseline to Week 4 in Plasma B Cell Level|The absolute number of plasma B cells was expressed as cells/mcL. Baseline AV and change from Baseline to Week 4 were averaged among all participants.|Baseline and Week 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||cells/mcL||Standard Deviation|Mean
805367|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Plasma B Cells as a Percentage of B Cells|The intensity of plasma B cell infiltration was expressed as the percentage of B cells. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||percentage of B cells||Standard Deviation|Mean
805368|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Plasma B Cells as a Percentage of PBMCs|The intensity of plasma B cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||percentage of PBMCs||Standard Deviation|Mean
805369|NCT00996606|Secondary|Change From Baseline to Week 4 in Transitional B Cell Level|The absolute number of transitional B cells was expressed as cells/mcL. Baseline AV and change from Baseline to Week 4 were averaged among all participants.|Baseline and Week 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||cells/mcL||Standard Deviation|Mean
805370|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Transitional B Cells as a Percentage of B Cells|The intensity of transitional B cell infiltration was expressed as the percentage of B cells. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||percentage of B cells||Standard Deviation|Mean
805408|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in mRNA for IL-23 Receptor (2^ΔCt) Level|Level of mRNA for IL-23 receptor (2^ΔCt) was quantified by PCR. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||2^ΔCt||Standard Deviation|Mean
805371|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Transitional B Cells as a Percentage of PBMCs|The intensity of transitional B cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||percentage of PBMCs||Standard Deviation|Mean
805372|NCT00996606|Secondary|Change From Baseline to Week 4 in Memory B Cell Level|The absolute number of memory B cells was expressed as cells/mcL. Baseline AV and change from Baseline to Week 4 were averaged among all participants.|Baseline and Week 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||cells/mcL||Standard Deviation|Mean
805373|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Memory B Cells as a Percentage of B Cells|The intensity of memory B cell infiltration was expressed as the percentage of B cells. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||percentage of B cells||Standard Deviation|Mean
805374|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Memory B Cells as a Percentage of PBMCs|The intensity of memory B cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||percentage of PBMCs||Standard Deviation|Mean
805375|NCT00996606|Secondary|Change From Baseline to Week 4 in Mature B Cell Level|The absolute number of mature B cells was expressed as cells/mcL. Baseline AV and change from Baseline to Week 4 were averaged among all participants.|Baseline and Week 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||cells/mcL||Standard Deviation|Mean
805376|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Mature B Cells as a Percentage of B Cells|The intensity of mature B cell infiltration was expressed as the percentage of B cells. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||percentage of B cells||Standard Deviation|Mean
805377|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Mature B Cells as a Percentage of PBMCs|The intensity of mature B cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||percentage of PBMCs||Standard Deviation|Mean
805378|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in IgM Mean Intensity of Fluorescence|The mean fluorescence intensity of IgM-positive cells was measured by flow cytometry. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||fluorescence intensity units||Standard Deviation|Mean
805379|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Immunoglobulin (Ig) M-Positive Cells as a Percentage of PBMCs|The intensity of IgM-positive cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||percentage of PBMCs||Standard Deviation|Mean
805380|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in CD38 Mean Intensity of Fluorescence|The mean fluorescence intensity of CD38-positive cells was measured by flow cytometry. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||fluorescence intensity units||Standard Deviation|Mean
805381|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in CD38-Positive Cells as a Percentage of PBMCs|The intensity of CD38-positive cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||percentage of PBMCs||Standard Deviation|Mean
805382|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in CD27 Mean Intensity of Fluorescence|The mean fluorescence intensity of CD27-positive cells was measured by flow cytometry. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||fluorescence intensity units||Standard Deviation|Mean
805383|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in CD27-Positive Cells as a Percentage of PBMCs|The intensity of CD27-positive cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||percentage of PBMCs||Standard Deviation|Mean
805384|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in CD24 Mean Intensity of Fluorescence|The mean fluorescence intensity of CD24-positive cells was measured by flow cytometry. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||fluorescence intensity units||Standard Deviation|Mean
805385|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in CD24-Positive Cells as a Percentage of PBMCs|The intensity of CD24-positive cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||percentage of PBMCs||Standard Deviation|Mean
805386|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in CD19 Mean Intensity of Fluorescence|The mean fluorescence intensity of CD19-positive cells was measured by flow cytometry. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||fluorescence intensity units||Standard Deviation|Mean
805387|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in CD19-Positive Cells as a Percentage of PBMCs|The intensity of CD19-positive cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||percentage of PBMCs||Standard Deviation|Mean
805388|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Th17 Cell Level|The absolute number of Th17 cells was expressed as cells/mcL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||cells/mcL||Standard Deviation|Mean
805389|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Th17 Cells as a Percentage of T Cells|The intensity of Th17 cell infiltration was expressed as the percentage of T cells. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||percentage of T cells||Standard Deviation|Mean
805390|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Helper T (Th) 17 Cells as a Percentage of PBMCs|The intensity of Th17 cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||percentage of PBMCs||Standard Deviation|Mean
805391|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Treg Cell Level|The absolute number of Treg cells was expressed as cells per microliter (cells/mcL). Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||cells/mcL||Standard Deviation|Mean
805392|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Treg Cells as a Percentage of T Cells|The intensity of Treg cell infiltration was expressed as the percentage of T cells. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||percentage of T cells||Standard Deviation|Mean
805393|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Regulatory T (Treg) Cells as a Percentage of PBMCs|The intensity of Treg cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||percentage of PBMCs||Standard Deviation|Mean
805394|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in IL-23Rp19 Mean Intensity of Fluorescence|The mean fluorescence intensity of IL-23Rp19-positive cells was measured by flow cytometry. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||fluorescence intensity units||Standard Deviation|Mean
805395|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in IL-23 Receptor p19 Subunit (IL-23Rp19)-Positive Cells as a Percentage of PBMCs|The intensity of IL-23Rp19-positive cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||percentage of PBMCs||Standard Deviation|Mean
805438|NCT00996658|Secondary|Occurrence of Absolute Efficacy Response (HbA1c < 6.5%) After 24 Weeks|Glycosylated hemoglobin is reported as a percentage of the total hemoglobin|24 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication and had HbA1c >=6.5% at baseline (NCF). Three subjects in each arm excluded for site non-compliance.||Participants|||Number
805547|NCT01004354|Secondary|Changes in Serum Levels of Adiponectin, Leptin, and C-reactive Protein.||8 weeks||||||
805396|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in CCR4 Mean Intensity of Fluorescence|The mean fluorescence intensity of CCR4-positive cells was measured by flow cytometry. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||fluorescence intensity units||Standard Deviation|Mean
805397|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in CCR4-Positive Cells as a Percentage of PBMCs|The intensity of CCR4-positive cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||percentage of PBMCs||Standard Deviation|Mean
805398|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in CCR6 Mean Intensity of Fluorescence|The mean fluorescence intensity of CCR6-positive cells was measured by flow cytometry. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||fluorescence intensity units||Standard Deviation|Mean
805399|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Cysteine-Cysteine Chemokine Receptor (CCR) 6-Positive Cells as a Percentage of PBMCs|The intensity of CCR6-positive cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||percentage of PBMCs||Standard Deviation|Mean
805400|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in CD45RO Mean Intensity of Fluorescence|The mean fluorescence intensity of CD45RO-positive cells was measured by flow cytometry. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||fluorescence intensity units||Standard Deviation|Mean
805401|NCT00996606|Secondary|"Change From Baseline to Weeks 2 and 4 in CD45 RO Isoform (RO)-Positive Cells as a Percentage of PBMCs"|The intensity of CD45RO-positive cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||percentage of PBMCs||Standard Deviation|Mean
805402|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in CD25 Mean Intensity of Fluorescence|The mean fluorescence intensity of CD25-positive cells was measured by flow cytometry. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||fluorescence intensity units||Standard Deviation|Mean
805403|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in CD25-Positive Cells as a Percentage of PBMCs|The intensity of CD25-positive cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||percentage of PBMCs||Standard Deviation|Mean
805404|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in CD4 Mean Intensity of Fluorescence|The mean fluorescence intensity of CD4-positive cells was measured by flow cytometry. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||fluorescence intensity units||Standard Deviation|Mean
805405|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Cluster of Differentiation (CD) 4-Positive Cells as a Percentage of Peripheral Blood Mononuclear Cells (PBMCs)|The intensity of CD4-positive cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||percentage of PBMCs||Standard Deviation|Mean
805406|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in mRNA for Forkhead Box Protein (FOXP) 3 (2^ΔCt) Level|Level of mRNA for FOXP3 (2^ΔCt) was quantified by PCR. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||2^ΔCt||Standard Deviation|Mean
805407|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in mRNA for RAR-Related Orphan Receptor (ROR)-γT (2^ΔCt) Level|Level of ROR-γT (2^ΔCt) was quantified by PCR. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||2^ΔCt||Standard Deviation|Mean
805439|NCT00996658|Secondary|Occurrence of Absolute Efficacy Response (HbA1c < 7%) After 24 Weeks|Glycosylated hemoglobin is reported as a percentage of the total hemoglobin|24 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication and had HbA1c >=7.0% at baseline (NCF). Three subjects in each arm excluded for site non-compliance.||Participants|||Number
805409|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Messenger Ribonucleic Acid (mRNA) for Interleukin (IL)-17 (2^Delta Cycle Threshold [ΔCt]) Level|Level of mRNA for IL-17 (2^ΔCt) was quantified by polymerase chain reaction (PCR). Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||2^ΔCt||Standard Deviation|Mean
805410|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Soluble Interleukin-6 Receptor (sIL6R) Level|Level of sIL6R was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||pg/mL||Standard Deviation|Mean
805411|NCT00996606|Secondary|Change From Baseline to Weeks 2, 4, 12, 24, and 48 in High-Sensitivity C-Reactive Protein (hsCRP) Concentration|Level of hsCRP was measured in mg/dL. Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants.|Baseline and Weeks 2, 4, 12, 24, 48|ITT Population. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.||mg/dL||Standard Deviation|Mean
805412|NCT00996606|Secondary|Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Erythrocyte Sedimentation Rate (ESR)|ESR was measured in millimeters per hour (mm/h). Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants.|Baseline and Weeks 2, 4, 12, 24, 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||mm/h||Standard Deviation|Mean
805413|NCT00996606|Secondary|Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Vascular Endothelial Growth Factor (VEGF) Concentration|Level of VEGF was measured in picograms per milliliter (pg/mL). Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants.|Baseline and Weeks 2, 4, 12, 24, 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||pg/mL||Standard Deviation|Mean
805414|NCT00996606|Secondary|Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Disease Activity Score of 28 Joints (DAS28) Score|The DAS28 was derived from assessments of C-reactive protein (CRP), tender joint count (TJC), swollen joint count (SJC), and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] plus (+) [0.28 × square root of SJC] + [0.36 × natural log (CRP + 1)] + [0.014 × VAS] + 0.96. TJC was defined as the number of painful joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. CRP was measured in milligrams per deciliter (mg/dL). DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants, where negative changes indicated an improvement in disease activity.|Baseline and Weeks 2, 4, 12, 24, 48|ITT Population. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.||units on a scale||Standard Deviation|Mean
805415|NCT00996606|Secondary|Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Health Assessment Questionnaire Disability Index (HAQ-DI) Score|The HAQ-DI assessed 20 items in eight functional activity domains including dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. Each item was scored on a scale of 0 to 3, where 0 represented activities performed without difficulty and 3 represented inability to perform activities alone. The total score was calculated as an average of all item scores, and thus also ranged from 0 to 3. Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants, where negative changes indicated an increase in ability to perform activities independently.|Baseline and Weeks 2, 4, 12, 24, 48|ITT Population. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.||units on a scale||Standard Deviation|Mean
805416|NCT00996606|Secondary|Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Perceived General Health According to VAS Score|Global assessment of disease activity was performed using a 0- to 100-mm VAS, where the distance from 0 mm represented the investigator's evaluation or the participant's self evaluation of disease activity (0 mm = no disease activity, 100 mm = maximum disease activity). Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants, where negative changes indicated improvement in disease activity.|Baseline and Weeks 2, 4, 12, 24, 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||mm||Standard Deviation|Mean
805417|NCT00996606|Secondary|Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Perceived Pain According to Visual Analog Scale (VAS) Score|Perceived pain was assessed on a 0- to 100-millimeter (mm) VAS, where the distance from 0 mm represented the participant's self evaluation of pain (0 mm = no pain, 100 mm = maximum pain). Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants, where negative changes indicated a decrease in perceived pain.|Baseline and Weeks 2, 4, 12, 24, 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||mm||Standard Deviation|Mean
805418|NCT00996606|Secondary|Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Ritchie Articular Index Score|The Ritchie Articular Index was scored on a scale of 0 to 3, according to the grades of tenderness in each of 26 assessed joints. The total score was taken as the sum of joint scores and ranged from 0 to 78. Scores of 0 reflected no tenderness, while higher scores reflected increased tenderness. Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants, where negative changes indicated improvement in joint tenderness.|Baseline and Weeks 2, 4, 12, 24, 48|ITT Population. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.||units on a scale||Standard Deviation|Mean
805485|NCT01003184|Secondary|Percentage of Patients Achieving ≤7.0% at Endpoint|Percentage of patients achieving ≤7.0% at endpoint.|Week 26|The analysis was done for the FAS population (as randomised). Patients with baseline HbA1c ≤7.0% and/or no post-baseline HbA1c measurement were regarded as non-responders.||Percentage||95% Confidence Interval|Number
805419|NCT00996606|Secondary|Change From Baseline to Weeks 24 and 48 in Total Modified Sharp Score (TMSS), Erosion Score (ES), and Joint Space Narrowing Score (JSNS)|The TMSS was calculated as the sum of ES and JSNS and ranged from 0 to 202. The ES was taken as the sum of joint scores collected for 14 joints in each hand (individually scored from 0 to 7) and ranged from 0 to 98 for both hands. The JSNS was the sum of joint scores collected for 13 joints in each hand (individually scored from 0 to 8) and ranged from 0 to 104 for both hands. Scores of 0 reflected no change, while higher scores reflected increased disease activity. Baseline AV and changes from Baseline to Weeks 24 and 48 were averaged among all participants, where negative changes indicated improvement in disease activity.|Baseline and Weeks 24, 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||units on a scale||Standard Deviation|Mean
805420|NCT00996606|Secondary|Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Bone Marrow Edema of the Wrist and MCP Joints According to RAMRIS Score|Edema was evaluated at 15 sites in the wrist and 8 sites in the MCP joints. Bone edema was scored on a scale of 0 to 3, where 0 represented no bone edema and each 1-point increase reflected one-third increase in extent of edema. Global RAMRIS scores were calculated as the sum of all joint sites for the wrist (range, 0 to 45) and MCP joints (range, 0 to 24). Aggregate wrist and MCP joint scores could range from 0 to 69 points. Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants, where negative changes indicated improvement in edema.|Baseline and Weeks 2, 4, 12, 24, 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||units on a scale||Standard Deviation|Mean
805421|NCT00996606|Secondary|Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Number of Bones With Bone Marrow Edema in the Wrist and MCP Joints|Edema was evaluated at 15 sites in the wrist and 8 sites in the MCP joints. Bone edema was scored on a scale of 0 to 3, where 0 represented no bone edema and each 1-point increase reflected one-third increase in extent of edema. The number of bones with edema was taken as the count of joints with a bone edema score greater than or equal to (≥) 1. Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants, where negative changes indicated improvement in edema.|Baseline and Weeks 2, 4, 12, 24, 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||bones with bone marrow edema||Standard Deviation|Mean
805422|NCT00996606|Secondary|Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Erosion of the Wrist and MCP Joints According to RAMRIS Score|Erosion was evaluated at 15 sites in the wrist and 8 sites in the MCP joints. Bone erosion was scored on a scale of 0 to 10, where 0 represented no bone erosion and each 1-point increase reflected up to 10% increase in extent of erosion. Global RAMRIS scores were calculated as the sum of all joint sites for the wrist (range, 0 to 150) and MCP joints (range, 0 to 80). Aggregate wrist and MCP joint scores could range from 0 to 230 points. Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants, where negative changes indicated improvement in erosion.|Baseline and Weeks 2, 4, 12, 24, 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||units on a scale||Standard Deviation|Mean
805423|NCT00996606|Secondary|Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Number of Bones With Erosion in the Wrist and MCP Joints|Erosion was evaluated at 15 sites in the wrist and 8 sites in the MCP joints. Bone erosion was scored on a scale of 0 to 10, where 0 represented no bone erosion and each 1-point increase reflected up to a 10% increase in extent of erosion. The number of bones with erosion was taken as the count of joints with a bone erosion score greater than or equal to (≥) 1. Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants, where negative changes indicated improvement in erosion.|Baseline and Weeks 2, 4, 12, 24, 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||bones with erosion||Standard Deviation|Mean
805424|NCT00996606|Secondary|Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Synovitis of the Wrist and Metacarpo-Phalangeal (MCP) Joints According to Modified RAMRIS Score|Synovitis of the wrist was assessed at three sites including the RUJ, the RCJ, and the IC-CMCJ. Global RAMRIS scores were assigned on a scale of 0 to 3 at each site, where 0 represented normal appearance with no synovial enhancement and each 1-point increase reflected one-third of the presumed maximum volume of enhancing tissue in the synovial compartment. The scores for all three sites were added to give an aggregated score of 0 to 9. Synovitis of MCP joints was determined on the basis of Short Inversion Time Inversion Recovery (STIR) sequence evaluation with modification of the RAMRIS score. Four MCP joint compartments were each assessed 0 to 3, so the aggregated MCP joint score ranged from 0 to 12. Combined synovitis in wrist and MCP joints was determined on the basis of STIR sequences to produce overall score from 0 to 21. Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, 48 were averaged among all participants, where negative changes indicated improvement in synovitis.|Baseline and Weeks 2, 4, 12, 24, 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||units on a scale||Standard Deviation|Mean
805425|NCT00996606|Secondary|Change From Baseline to Weeks 2, 12, 24, and 48 in Synovitis of the Wrist According to REE Per Second Before and After Contrast Injection|REE per second was calculated as [S55 – S0] ÷ [S0 × 55 seconds] × 100%, where S0 was defined as the signal noise ratio before contrast injection, and S55 was defined as the signal noise ratio 55 seconds after injection. Signal noise ratios were measured as the ratio between the signal in the region of interest and the standard deviation of background noise. The changes from Baseline to Weeks 2, 12, 24, and 48 were averaged among all participants, where negative changes indicated improvement in synovitis.|Baseline and Weeks 2, 12, 24, 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||percent rate of early enhancement||Standard Deviation|Mean
805426|NCT00996606|Secondary|Change From Baseline to Weeks 2, 12, 24, and 48 in Synovitis of the Wrist According to RE Before and After Contrast Injection|RE was calculated as [S0 – S55] ÷ S0 × 100%, where S0 was defined as the signal noise ratio before contrast injection, and S55 was defined as the signal noise ratio 55 seconds after injection. Signal noise ratios were measured as the ratio between the signal in the region of interest and the standard deviation of background noise. The changes from Baseline to Weeks 2, 12, 24, and 48 were averaged among all participants, where negative changes indicated improvement in synovitis.|Baseline and Weeks 2, 12, 24, 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||percent relative enhancement||Standard Deviation|Mean
805427|NCT00996606|Secondary|Change From Baseline to Weeks 2, 12, 24, and 48 in Synovitis of the Wrist According to RAMRIS Score|Synovitis of the wrist was assessed at three sites including the RUJ, the RCJ, and the IC-CMCJ. Global RAMRIS scores were assigned on a scale of 0 to 3 at each site, where 0 represented normal appearance with no synovial enhancement and each 1-point increase reflected one-third of the presumed maximum volume of enhancing tissue in the synovial compartment. The scores for all three sites were added to give an aggregated score of 0 to 9. The changes from Baseline to Weeks 2, 12, 24, and 48 were averaged among all participants, where negative changes indicated improvement in synovitis.|Baseline and Weeks 2, 12, 24, 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||units on a scale||Standard Deviation|Mean
805428|NCT00996606|Primary|Change From Baseline to Week 4 in Synovitis of the Wrist According to Rate of Early Enhancement (REE) Per Second Before and After Contrast Injection|REE per second was calculated as [S55 – S0] ÷ [S0 × 55 seconds] × 100%, where S0 was defined as the signal noise ratio before contrast injection, and S55 was defined as the signal noise ratio 55 seconds after injection. Signal noise ratios were measured as the ratio between the signal in the region of interest and the standard deviation of background noise. Baseline AV and change from Baseline to Week 4 were averaged among all participants, where negative changes indicated improvement in synovitis.|Baseline and Week 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||percent rate of early enhancement||Standard Deviation|Mean
805429|NCT00996606|Primary|Change From Baseline to Week 4 in Synovitis of the Wrist According to Relative Enhancement (RE) Before and After Contrast Injection|RE was calculated as [S0 minus (–) S55] divided by (÷) S0, multiplied by (×) 100 percent (%), where S0 was defined as the signal noise ratio before contrast injection, and S55 was defined as the signal noise ratio 55 seconds after injection. Signal noise ratios were measured as the ratio between the signal in the region of interest and the standard deviation of background noise. Baseline AV and change from Baseline to Week 4 were averaged among all participants, where negative changes indicated improvement in synovitis.|Baseline and Week 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||percent relative enhancement||Standard Deviation|Mean
805430|NCT00996606|Primary|Change From Baseline to Week 4 in Synovitis of the Wrist According to Rheumatoid Arthritis Magnetic Resonance Imaging (RAMRIS) Score|Synovitis of the wrist was assessed at three sites including the radioulnar joint (RUJ), the radiocarpal joint (RCJ), and the intercarpal-carpometacarpal joints (IC-CMCJ). Global RAMRIS scores were assigned on a scale of 0 to 3 at each site, where 0 represented normal appearance with no synovial enhancement and each 1-point increase reflected one-third of the presumed maximum volume of enhancing tissue in the synovial compartment. The scores for all three sites were added to give an aggregated score of 0 to 9. Baseline absolute value (AV) and change from Baseline to Week 4 were averaged among all participants, where negative changes indicated improvement in synovitis.|Baseline and Week 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||units on a scale||Standard Deviation|Mean
805431|NCT00996632|Secondary|Time of Discharge|evaluation about the time of discharge from hospital|days|||Days||Standard Deviation|Mean
805432|NCT00996632|Primary|Drainage Volume|volume in milliliters of axillary drainage|discharge day|the number of participants for analysis was determined by mean of power sample size calculation||milliliters||Standard Deviation|Mean
805433|NCT00996658|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) After 18 Weeks|Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 18|baseline, 18 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline FPG value and an on-treatment FPG value. Three subjects in each arm excluded for site non-compliance.||mg/dL (milligrams per deciliter)||Standard Error|Least Squares Mean
805434|NCT00996658|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) After 12 Weeks|Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 12|baseline, 12 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline FPG value and an on-treatment FPG value. Three subjects in each arm excluded for site non-compliance.||mg/dL (milligrams per deciliter)||Standard Error|Least Squares Mean
805435|NCT00996658|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) After 6 Weeks|Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 6|baseline, 6 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline FPG value and an on-treatment FPG value. Three subjects in each arm excluded for site non-compliance.||mg/dL (milligrams per deciliter)||Standard Error|Least Squares Mean
805436|NCT00996658|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks|Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 24|baseline, 24 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline FPG value and an on-treatment FPG value. Three subjects in each arm excluded for site non-compliance.||mg/dL (milligrams per deciliter)||Standard Error|Least Squares Mean
805437|NCT00996658|Secondary|Occurrence of Relative Efficacy Response (Reduction in HbA1c >= 0.5%) After 24 Weeks|Glycosylated hemoglobin is reported as a percentage of the total hemoglobin|24 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication. Three subjects in each arm excluded for site non-compliance.||Participants|||Number
805443|NCT00996658|Primary|Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 24 Weeks|Glycosylated hemoglobin is reported as a percentage of the total hemoglobin|baseline, 24 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline HbA1c value and an on-treatment HbA1c value. Three subjects in each arm excluded for site non-compliance.||Percentage||Standard Error|Least Squares Mean
805444|NCT00996736|Secondary|Microbiological Cure at 6 Days|Microbiological cure defined as no fungal growth on culture at 6 (+/-1) days from enrollment|7 days after enrollment|||participants|||Number
805445|NCT00996736|Secondary|Minimum Inhibitory Concentration of Isolates|Minimum inhibitory concentration (50th percentile) of fungal isolates to natamycin and voriconazole|3 months after enrollment|The population for analysis included only those subjects with positive fungal cultures and for whom Minimum Inhibitory Concentrations were available (108 subjects who were randomized to natamycin and 113 who were randomized to voriconazole).||μg/ml||95% Confidence Interval|Mean
805446|NCT00996736|Secondary|Time to Resolution of Epithelial Defect|Time in days from enrollment to resolution of epithelial defect. For those subjects with more than 21 days to resolution, 21 days was used.|From enrollment to the time of resolution of epithelial defect|||days||Standard Deviation|Mean
805447|NCT00996736|Secondary|Size of Infiltrate/Scar|Size of infiltrate/scar at 3 weeks and 3 months after enrollment, using enrollment infiltrate scar/size as a covariate|3 weeks and 3 months after enrollment|||mm||95% Confidence Interval|Mean
805448|NCT00996736|Secondary|Hard Contact Lens-corrected Visual Acuity Measured in logMAR|Hard contact lens-corrected visual acuity measured in logMAR (logarithm of the Minimum Angle of Resolution) 3 months after enrollment|3 months after enrollment|||logMAR||95% Confidence Interval|Mean
805449|NCT00996736|Secondary|Best Spectacle-corrected logMAR Visual Acuity|Best spectacle-corrected logMAR (logarithm of the Minimum Angle of Resolution) visual acuity at 3 weeks after enrollment, adjusting for enrollment BSCVA and treatment arm in a multiple linear regression model|3 weeks after enrollment|306 total subjects (155 in natamycin arm, 151 in voriconazole arm) returned after enrollment for a second visit, but only 293 of those (149 in natamycin arm and 144 in voriconazole arm) visited within the 3-week window (2.5-5 weeks). Only those who visited within the window were included in the analysis.||logMAR||95% Confidence Interval|Mean
805450|NCT00996736|Primary|Best Spectacle-corrected logMAR Visual Acuity|The primary analysis is best spectacle-corrected logMAR (logarithm of the Minimum Angle or Resolution) visual acuity, correcting for enrollment BSCVA and treatment arm in a multiple linear regression model. The pre-specified non-inferiority margin is less than 1.5 lines logMAR acuity. (Adjusted three-month visual acuity confidence bounds for the difference between the voriconazole and natamycin groups which meet or exceed 0.15 logMAR units would not permit noninferiority to be declared.) Note that this design also allows declaration of superiority (2-sided alpha of 0.05, corrected for an interim analysis).|3 months from enrollment|||logMAR||95% Confidence Interval|Mean
805451|NCT00996775|Primary|Reduction in Percentage of Heavy Drinking Days|"reduction in the percentage of heavy drinking days over the prior 30-days.
a heavy drinking day was defined as drinking above gender-matched NIAAA drinking limits (e.g., greater than 4 drinks on one occasion for men)."|baseline to six-month follow-up|||percentage of heavy drinking days||Standard Deviation|Mean
805452|NCT00996801|Primary|Number of Participants With Predefined Tier 1 Adverse Events|Osteonecrosis of the jaw (ONJ), kidney stones, and bone neoplasms were predefined Tier-1 AEs in the study (an AE of special interest identified a priori that could be used for inferential testing for statistical significance for between-group comparisons).|Baseline through Month 12|All Participants as Treated (APaT): all randomized participants who received at least one dose of study treatment.||Participants|||Number
805453|NCT00996801|Primary|Number of Participants With Trough Albumin-Corrected Calcium Level Exceeding Predefined Limits At Least Once|"Albumin-Corrected Calcium = ([4 - plasma albumin in g/dL] × 0.8 + serum calcium).
≥10.6 mg/dL was predefined in this study as the cut-off for the normal limits of change. Participants with at least one albumin-corrected calcium level value ≥10.6 mg/dL were considered as having a Tier 1 AE (an AE of special interest identified a priori that could be used for inferential testing for statistical significance for between-group comparisons)."|Baseline through Month 12|All Participants as Treated (APaT): all randomized participants who received at least one dose of study treatment.||Participants|||Number
805454|NCT00996801|Primary|Number of Participants With Trough Serum Calcium Level Exceeding Predefined Limits At Least Once|"Normal serum calcium level is 8-10 mg/dL (2-2.5 mmol/L) with some interlaboratory variation in the reference range, and hypercalcemia is defined as a serum calcium level greater than 10.5 mg/dL (>2.5 mmol/L).
Based on these references, ≥10.6 mg/dL was predefined in this study as the cut-off for the normal limits of change. Participants with at least a one calcium level value ≥10.6 mg/dL were considered as having a Tier 1 adverse event (AE). A Tier 1 AE was an AE of special interest identified a priori that could be used for inferential testing for statistical significance for between-group comparisons."|Baseline through Month 12|All Participants as Treated (APaT): all randomized participants who received at least one dose of study treatment.||Participants|||Number
805455|NCT00996801|Secondary|Least Squares Mean Percent Change From Baseline to Month 12 in Serum Osteocalcin|"Serum osteocalcin is a biomarker of bone formation and is measured using units of nanograms (ng) / milliliter
(mL)."|Baseline and Month 12|Analysis of osteocalcin was not conducted when it was determined that the efficacy of MK-5442 was not significantly different than placebo.|||||
805456|NCT00996801|Secondary|Least Squares Mean Percent Change From Baseline to Month 12 in Serum Bone-Specific Alkaline Phosphatase (s-BSAP)|Bone Specific Alkaline Phosphatase is a biomarker of bone formation and is measured in units of μg/L.|Baseline and Month 12|"Per Protocol Population: defined as the subset of the APaT population that excluded participants based on critical protocol violations.
The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed."||percent change||95% Confidence Interval|Least Squares Mean
805457|NCT00996801|Secondary|Least Squares Mean Percent Change From Baseline to Month 12 in Serum N-Terminal Propeptide (s-P1NP)|s-P1NP is a sensitive marker of bone formation rate in the assessment of osteoporosis and is measured in units of ng/ml.|Baseline and Month 12|"Per Protocol Population: defined as the subset of the APaT population that excluded participants based on critical protocol violations.
The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed."||percent change||95% Confidence Interval|Least Squares Mean
805458|NCT00996801|Secondary|Least Squares Mean Percent Change From Baseline to Month 12 in Serum C-Terminal Propeptide of Type 1 Collagen (s-CTx)|C-Terminal Telopeptide Collagen I is used as a serum-marker of bone resorption in the assessment of osteoporosis and in measured in units of nanograms (n)/milliliter (ml).|Baseline and Month 12|"Per Protocol Population: defined as the subset of the APaT population that excluded participants based on critical protocol violations.
The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed."||percent change||95% Confidence Interval|Least Squares Mean
805459|NCT00996801|Secondary|Least Squares Mean Percent Change From Baseline to Month 12 in Urinary-N Telopeptides of Type 1 Collagen (u-NTx)|"Urinary, type I collagen, crosslinked N-telopeptide (uNTx) is a biomarker used to measure the rate of bone turnover found in urine.
uNTx was expressed in units of nanomoles (nM) per bone collagen equivalents (BCE) per millimoles of creatinine (Cr) or nM/BCE/mM Cr"|Baseline and Month 12|"Per Protocol Population: defined as the subset of the APaT population that excluded participants based on critical protocol violations.
The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed."||percent change||95% Confidence Interval|Least Squares Mean
805460|NCT00996801|Secondary|Least Squares Mean Percent Change From Baseline to Month 12 in Cortical Volumetric BMD of the Hip|vBMD was measured using QCT in order to assess bone strength. QCT is a three-dimensional non-projectional technique that quantifies trabecular and cortical BMD in the lumbar spine and hip as a true volumetric mineral density in g/cm^3.|Baseline and Month 12|"Full Analysis Set (FAS), QCT Subset: QCT was performed on a subset of the FAS (participants who received at least one dose of study treatment, had at least one post-randomization observation, and who had baseline data).
The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcomes analyses were performed."||percent change||95% Confidence Interval|Least Squares Mean
805461|NCT00996801|Secondary|Least Squares Mean Percent Change From Baseline to Month 12 in Cortical Volumetric BMD of the Lumbar Spine|vBMD was measured using QCT in order to assess bone strength. QCT is a three-dimensional non-projectional technique that quantifies trabecular and cortical BMD in the lumbar spine and hip as a true volumetric mineral density in g/cm^3.|Baseline and Month 12|"Full Analysis Set (FAS), QCT Subset: QCT was performed on a subset of the FAS (participants who received at least one dose of study treatment, had at least one post-randomization observation, and who had baseline data).
The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed."||percent change||95% Confidence Interval|Least Squares Mean
805462|NCT00996801|Secondary|Least Squares Mean Percent Change From Baseline to Month 12 in Trabecular Volumetric BMD of the Hip|vBMD was measured using QCT in order to assess bone strength. QCT is a three-dimensional non-projectional technique that quantifies trabecular and cortical BMD in the lumbar spine and hip as a true volumetric mineral density in g/cm^3.|Baseline and Month 12|"Full Analysis Set (FAS), QCT Subset: QCT was performed on a subset of the FAS (participants who received at least one dose of study treatment, had at least one post-randomization observation, and who had baseline data).
The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed."||percent change||95% Confidence Interval|Least Squares Mean
805463|NCT00996801|Secondary|Least Squares Mean Percent Change From Baseline to Month 12 in Trabecular Volumetric BMD (vBMD) of the Lumbar Spine|vBMD was measured using quantitative computed tomography (QCT) in order to assess bone strength. Quantitative computed tomography is a three-dimensional non-projectional technique that quantifies trabecular and cortical BMD in the lumbar spine and hip as a true volumetric mineral density in g/cm^3.|Baseline and Month 12|"Full Analysis Set (FAS), QCT Subset: QCT was performed on a subset of the FAS (participants who received at least one dose of study treatment, had at least one post-randomization observation, and who had baseline data).
The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed."||percent change||95% Confidence Interval|Least Squares Mean
805464|NCT00996801|Secondary|Least Squares Mean Percent Change From Baseline to Month 12 in 1/3 Distal Forearm Areal BMD|"Areal bone mineral density (BMD) was measured using DXA scanning technology. Scanning is performed with two X-ray beams with different energy levels which are aimed at the participant's bones. When soft tissue absorption is subtracted out, the BMD is determined from the absorption of each beam by bone.
BMD = BMC / W, where BMD = bone mineral density in g/cm^2, BMC = bone mineral content in g/cm, and W = width at the scanned line in cm"|Baseline and Month 12|"Full Analysis Set (FAS): participants who received at least one dose of study treatment, had at least one post-randomization observation, and who had baseline data.
The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed."||percent change||95% Confidence Interval|Least Squares Mean
805465|NCT00996801|Secondary|Least Squares Mean Percent Change From Baseline to Month 12 in Total Body Areal BMD|"Areal bone mineral density (BMD) was measured using DXA scanning technology. Scanning is performed with two X-ray beams with different energy levels which are aimed at the participant's bones. When soft tissue absorption is subtracted out, the BMD is determined from the absorption of each beam by bone.
BMD = BMC / W, where BMD = bone mineral density in g/cm^2, BMC = bone mineral content in g/cm, and W = width at the scanned line in cm"|Baseline and Month 12|"Full Analysis Set (FAS): participants who received at least one dose of study treatment, had at least one post-randomization observation, and who had baseline data.
The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed."||percent change||95% Confidence Interval|Least Squares Mean
805466|NCT00996801|Secondary|Least Squares Mean Percent Change From Baseline to Month 12 in Trochanter Areal BMD|"Areal bone mineral density (BMD) was measured using DXA scanning technology. Scanning is performed with two X-ray beams with different energy levels which are aimed at the participant's bones. When soft tissue absorption is subtracted out, the BMD is determined from the absorption of each beam by bone.
BMD = BMC / W, where BMD = bone mineral density in g/cm^2, BMC = bone mineral content in g/cm, and W = width at the scanned line in cm"|Baseline and Month 12|"Full Analysis Set (FAS): participants who received at least one dose of study treatment, had at least one post-randomization observation, and who had baseline data.
The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed."||percent change||95% Confidence Interval|Least Squares Mean
805486|NCT01003184|Secondary|Percentage of Patients Achieving HbA1c ≤7.4% at Endpoint|Percentage of patients who have achieved HbA1c ≤.7.4% at endpoint|Week 26|The analysis was done for the FAS population (as randomised). Patients with baseline HbA1c ≤7.0% and/or no post-baseline HbA1c measurement were regarded as non-responders.||Percentage||95% Confidence Interval|Number
805467|NCT00996801|Secondary|Least Squares Mean Percent Change From Baseline to Month 12 in Femoral Neck Areal BMD|"Areal bone mineral density (BMD) was measured using DXA scanning technology. Scanning is performed with two X-ray beams with different energy levels which are aimed at the participant's bones. When soft tissue absorption is subtracted out, the BMD is determined from the absorption of each beam by bone.
BMD = BMC / W, where BMD = bone mineral density in g/cm^2, BMC = bone mineral content in g/cm, and W = width at the scanned line in cm"|Baseline and Month 12|"Full Analysis Set (FAS): participants who received at least one dose of study treatment, had at least one post-randomization observation, and who had baseline data.
The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed."||percent change||95% Confidence Interval|Least Squares Mean
805468|NCT00996801|Secondary|Least Squares Mean Percent Change From Baseline to Month 12 in Total Hip Areal BMD|"Areal bone mineral density (BMD) was measured using DXA scanning technology. Scanning is performed with two X-ray beams with different energy levels which are aimed at the participant's bones. When soft tissue absorption is subtracted out, the BMD is determined from the absorption of each beam by bone.
BMD = BMC / W, where BMD = bone mineral density in g/cm^2, BMC = bone mineral content in g/cm, and W = width at the scanned line in cm"|Baseline and Month 12|"Full Analysis Set (FAS): participants who received at least one dose of study treatment, had at least one post-randomization observation, and who had baseline data.
The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed."||percent change||95% Confidence Interval|Least Squares Mean
805469|NCT00996801|Primary|Least Squares Mean Percent Change From Baseline To Month 12 in Lumbar Spine Areal Bone Mineral Density (BMD)|"Areal bone mineral density (BMD) was measured using dual-energy X-ray absorptiometry (DXA) scanning technology. Scanning is performed with two X-ray beams with different energy levels which are aimed at the participant's bones. When soft tissue absorption is subtracted out, the BMD is determined from the absorption of each beam by bone.
BMD = BMC / W, where BMD = bone mineral density in g/cm^2, BMC = bone mineral content in g/cm, and W = width at the scanned line in cm"|Baseline and Month 12|"Full Analysis Set (FAS): participants who received at least one dose of study treatment, had at least one post-randomization observation, and who had baseline data.
The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed."||percent change||95% Confidence Interval|Least Squares Mean
805470|NCT01003080|Secondary|Change in Hemoglobin and Hematocrit.||First three days after surgery.||||||
805471|NCT01003080|Primary|Drain Output.|This is a measure of the average drain output collected in the first 24 hours following surgery.|First 24 hours following surgery.|||mL||Standard Deviation|Mean
805472|NCT01003106|Secondary|Mean Change From Month 6 to Month 36 in Central Subfield Thickness in Patients Treated With Prn Ranibizumab+Laser Photocoagulation Versus Prn Ranibizumab Alone.||Month 6- Month 36|||microns||Standard Error|Mean
805473|NCT01003106|Secondary|Mean Change From Baseline to Month 6 in Central Subfield Thickness in Patients Treated With 0.5mg Versus 2.0mg of Ranibizumab||Baseline to month 6|||microns||Standard Error|Mean
805474|NCT01003106|Secondary|Mean Change From Month 6 to Month 36 in Best Corrected Visual Acuity in Patients Treated With Prn Ranibizumab+Laser Photocoagulation Versus Prn Ranibizumab Alone.||Month 6- Month 36|||Letters||Standard Error|Mean
805475|NCT01003106|Secondary|Mean Change From Baseline to Month 6 in Best Corrected Visual Acuity in Patients Treated With 0.5mg Versus 2.0mg of Ranibizumab||Baseline to month 6|||Letters||Standard Error|Mean
805476|NCT01003106|Primary|Incidence and Severity of Ocular and Non-ocular Adverse Events.||36 months|||participants|||Number
805477|NCT01003184|Secondary|Hypoglycemia Rate Per Year|All confirmed hypoglycemia episodes defined as either minor (any time a patient feels that he or she is experiencing a sign or symptom associated with hypoglycaemia and blood glucose (BG) <3.0 mmol/L (54 mg/dL)) or major (any hypoglycaemic episode with symptoms consistent with hypoglycaemia, resulting in loss of consciousness or seizure, and shows prompt recovery in response to administration of glucagon or glucose, or BG measurement < 3.0mmol/L is available and the patient is not capable of self-treating were taken into account.|Baseline, Week 26|Full analysis set (as randomized).||events per subject-year||95% Confidence Interval|Number
805478|NCT01003184|Secondary|Change in Triglycerides From Baseline to Endpoint (Week 26).|Change in triglycerides from baseline to endpoint (week 26).|Baseline, Week 26|The analysis was done for the FAS population (as randomised). The last observation carried forward (LOCF) of post baseline values was used for this analysis.||mmol/L||Standard Error|Least Squares Mean
805479|NCT01003184|Secondary|Change in High-density Lipoprotein (HDL) Cholesterol From Baseline to Endpoint (Week 26).|Change in High-density lipoprotein (HDL) cholesterol from baseline to endpoint (week 26).|Baseline, Week 26|The analysis was done for the FAS population (as randomised). The last observation carried forward (LOCF) of post baseline values was used for this analysis.||mmol/L||Standard Error|Least Squares Mean
805480|NCT01003184|Secondary|Change in Total Cholesterol From Baseline to Endpoint (Week 26).|Change in total cholesterol from baseline to endpoint (week 26).|Baseline, Week 26|"The analysis was done for the FAS population (as randomised).
The last observation carried forward (LOCF) of post baseline values was used for this analysis."||mmol/L||Standard Error|Least Squares Mean
805481|NCT01003184|Secondary|Change in Diastolic Blood Pressure From Baseline to Week 26.|Change in diastolic blood pressure from baseline to week 26.|Baseline, Week 26|The analysis was done for the FAS population (as randomised).||mmHg||Standard Error|Least Squares Mean
805482|NCT01003184|Secondary|Changes in Systolic Blood Pressure From Baseline to Week 26|Change in systolic blood pressure from baseline to Week 26|Baseline, Week 26|The analysis was done for the FAS population (as randomised).||mmHg||Standard Error|Least Squares Mean
805483|NCT01003184|Secondary|Change in Fasting Serum Glucose From Baseline to Endpoint (Week 26).|Change in fasting serum glucose from baseline to endpoint (Week 26).|Baseline, Week 26|"The analysis was done for the FAS population (as randomised).
The last observation carried forward (LOCF) of post baseline values was used for this analysis."||mmol/L||Standard Error|Least Squares Mean
805484|NCT01003184|Secondary|Percentage of Patients Achieving ≤6.5% at Endpoint|Percentage of patients achieving HbA1c ≤6.5% at endpoint|Week 26|The analysis was done for the FAS population (as randomised). Patients with baseline HbA1c ≤7.0% and/or no post-baseline HbA1c measurement were regarded as non-responders.||Percentage||95% Confidence Interval|Number
805489|NCT01003184|Secondary|Percentage of Patients Who Have Achieved HbA1c ≤7.4% With Weight Loss (≥1.0 kg) at Endpoint (Week 26)|Percentage of patients who have achieved HbA1c ≤7.4% with weight loss (≥1.0 kg) at endpoint (Week 26)|Baseline, Week 26|The analysis was done for the FAS population (as randomised). For secondary analyses including both final HbA1c concentration and change in weight the last post-baseline measurement set of both non-missing HbA1c and weight was used as endpoint value.||Percentage||95% Confidence Interval|Number
805490|NCT01003184|Primary|Percentage of Patients Achieving Glycosylated Hemoglobin (HbA1c) Concentration ≤7.0% With Weight Loss (≥1.0 kg) at Endpoint (Week 26)|The primary endpoint is the percentage of patients achieving HbA1c concentration ≤7.0% with weight loss (≥1.0 kg) at endpoint. The last post-baseline measurement set of both non-missing HbA1c concentration and weight (measured at the same time point, i.e. visit) is used as endpoint value. Patients who do not have a baseline weight measurement, have a protocol violation of baseline HbA1c <=7.0%, and/or have missing post-baseline measurements for HbA1c concentration and/or weight, are included in the analysis as non-responders regarding the primary objective.|Baseline, Week 26|The full analysis set (FAS) includes all data from all randomised patients receiving at least one dose of the study drug according to the treatment the patients were assigned.||Percentage||95% Confidence Interval|Number
805491|NCT01003210|Secondary|Side Effects From Study Remedy|"Any other symptoms reported by parents in logbooks. Logbooks were returned by 72/105 participants randomized to the homeopathic ear drops group and 78 of those randomized to standard therapy alone."|15 days|The number of participants analyzed includes only those whose parents returned logbooks.||participants|||Number
805492|NCT01003210|Primary|Administration of Antibiotics|Number of participants who filled antibiotic prescription (or called back for promised antibiotic prescription) after being diagnosed with acute otitis media at index visit.|15 days|||participants|||Number
805493|NCT01003210|Primary|Severity of Symptoms of Otitis Media||15 days||||||
805494|NCT01003275|Primary|Glucose Area Under the Curve (AUC)|Glucose AUC during a 2-hour oral glucose tolerance test|8 weeks|||mg*min/dL||Geometric Coefficient of Variation|Geometric Mean
805495|NCT01003288|Secondary|Number of Participants With Immunogenicity as Determined Using Haemagglutination Inhibition Assay|Antibody responses were measured using the HI assay to evaluate the rapidity and long term duration of the response|7, 14, 21 days post vaccination and long term follow up for 5 years|Only HCW 251 were assessed for HI antibodies at 21 days post vaccination||participants|||Number
805496|NCT01003288|Primary|Number of Participants With Local and Systemic Adverse Events|Solicited adverse events were collected on side reactions form which were filled in for 21 days after pandemic or seasonal vaccination.|21 days after vaccination|solicited adverse event forms were collected from the volunteers||participants|||Number
805497|NCT01003301|Primary|The the Size of the 8 Late-phase Skin Response|Reduction in skin late phase size at 8 hours at the time of blood basophil hypo-responsiveness to allergen will be reduced compared to baseline.|Baseline, 2-6 wks|||percentage decline from NAC-1||Standard Deviation|Mean
805498|NCT01003886|Secondary|Percentage of Participants With Postural Hypotension|Postural or orthostatic hypotension is a medical condition where blood pressure falls rapidly after the body changes position most commonly occurring after standing up after sitting for long periods of time.|Baseline up to Week 13 (7 days after last dose)|Safety population included participants who had taken at least 1 dose of the study medication.||Percentage of participants|||Number
805499|NCT01003886|Secondary|Change From Baseline in Diastolic BP at Week 4 and Week 12|Values at Week 4 and Week 12 minus value at baseline.|Baseline through Week 12|Safety population included participants who had taken at least 1 dose of the study medication. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time points for each group respectively.||mmHg||Standard Deviation|Mean
805500|NCT01003886|Secondary|Change From Baseline in Systolic BP at Week 4 and Week 12|Values at Week 4 and Week 12 minus value at baseline.|Baseline through Week 12|Safety population included participants who had taken at least 1 dose of the study medication. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time points for each group respectively.||mmHg||Standard Deviation|Mean
805501|NCT01003886|Secondary|Percent Change From Baseline in the IPSS Quality of Life (QoL) Score at Week 4 and Week 12|The IPSS QoL Score is obtained by assessment of a single QoL question on a 7-point likert scale which was scored on a scale of 0-6 where 0 = best possible score to 6 = worst possible score.|Baseline, Week 4 and Week 12|FAS population included participants who had taken at least 1 dose of the study medication. Missing post-baseline data was replaced by the LOCF. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time points for each group respectively.||Units on a scale||Standard Deviation|Mean
805502|NCT01003886|Secondary|Percent Change From Baseline in the International Prostate Symptom (IPSS) Total Score at Week 4 and Week 12|The IPSS total score is obtained by combining the scores of the responses to 1 through 7 component questions all of which were on a 6 point likert scale. Each question is scored from 0-5 for an IPSS range of 0-35 points where 0 = best possible score to 35 = worst possible score.|Baseline, Week 4 and Week 12|Full analysis set (FAS) population included participants who had taken at least 1 dose of the study medication. Missing post-baseline data was replaced by the last observation carried forward (LOCF). The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time points for each group respectively.||Units on a scale||Standard Deviation|Mean
805503|NCT01003886|Primary|Number of Participants With Adverse Events (AEs)|Any untoward medical occurrence in a participant who received study drug was considered an AE, without regard to possibility of causal relationship.|Baseline up to Week 13 (7 days after last dose)|Safety population included participants who had taken at least 1 dose of the study medication.||Participants|||Number
805504|NCT01003899|Secondary|Duration of OR|Duration of OR was measured from the time the criteria for CR or PR (whichever was documented first) were first met until the first date that progressive disease or death was objectively documented.|Baseline till progression or death||||||
805505|NCT01003899|Secondary|Time to OR|The time to objective response (OR) was the duration from the first treatment to the time when the measurement criteria for CR and/or PR were met according to RECIST 1.1 criteria.|Baseline till progression or death||||||
805506|NCT01003899|Secondary|Duration of Disease Control (DC)|Duration of diesease control (DC) (objective response or stable disease (SD) as determined by RECIST version 1.1).|Baseline till progression or death|FAS - Full Analysis Set||weeks||Full Range|Median
805509|NCT01003899|Primary|Percentage of Participants With Best Objective Response|Percentage of participants with best objective response: confirmed complete response (CR) or confirmed partial response (PR) according to RECIST (version 1.1).|Baseline till progression or death|FAS (Full Analysis Set). The FAS consisted of all treated patients, excluding any patients found not be EGFR mutation negative according to central laboratory testing.||Percentage of participants||95% Confidence Interval|Number
805510|NCT01003938|Secondary|Toxicity Profile|"Number of participants (patients) who experienced AEs.
Dry skin, dry eye, acne, erythema, rash, pruritus, and diarrhea were related erlotinib; dehydration, anemia, leukopenia, nausea, vomiting, platelets, and fatigue were realted to topotcan."|the whole treatment phase and 30 days post-treatment|||participants|||Number
805511|NCT01003938|Secondary|Overall Survival|estimated total time from the start of the trial|4 years|The study was terminated very early (6 enrolled vs. 30 target accrual). No statistical analysis was performed on patient data.|||||
805512|NCT01003938|Secondary|Time to Progression|Time to progression is defined as the time from first study drug administration until the first day radiological and /or symptomatic disease progression is documented, or until death in the absence of progression.|Up to 3 years|The study was terminated very early (6 enrolled vs. 30 target accrual). No statistical analysis was performed on patient data.|||||
805513|NCT01003938|Secondary|CA125 Stable Disease Duration|Stable disease (SD) duration is measured from the tile of start of therapy until the criteria for progression are met. SD: CA125 decreases <50% or increases <100%. Disease progression: CA125 doubles the value of baseline, or more, over time.|Up to 3 years|The study was terminated very early (6 enrolled vs. 30 target accrual). No statistical analysis was performed on patient data.|||||
805514|NCT01003938|Secondary|CA125 Response Duration|Response duration is measured from the time measurement criteria for CA125 CR/PR at the first met until the first date that recurrent or progressive disease is objectively documented.|Up to 3 years|The study was terminated very early (6 enrolled vs. 30 target accrual). No statistical analysis was performed on patient data.|||||
805515|NCT01003938|Primary|CA125 Response Rate With Continuous-infusion Topotecan and Erlotinib|Response was assessed after every treatment cycle. Response rate is defined as number of the patients who experienced complete or partial CA125 response (CR or PR). CR: normalization of the CA125 value, determined by 2 observations not less than 4 weeks apart; PR: CA125 decreases by >50% and is confirmed to be 50% or greater on a subsequent determination at least one month later.|Up to 3 years|||participants|||Number
805516|NCT01003990|Primary|Number of Participants With Serious Adverse Events (SAEs), Treatment Related SAEs, Treatment Related Adverse Events (AEs), AEs Leading to Discontinuation of Study Therapy, Grade 3 to Grade 4 AEs, Grade 3 to Grade 4 AEs, CDC Class C AIDS Events, or Death|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. AIDS Defining Diagnosis ( CDC Class C AIDS Events) are identified from HIV Related Diagnosis.|Date of First Dose to 30 days post the last dose; approximately 405 weeks)|All Treated Participants||Participants|||Count of Participants
805523|NCT01004146|Secondary|Respiratory Rate||one week prior to surgery to post operative day 1||||||
805524|NCT01004146|Secondary|Heart Rate||one week prior to surgery to post operative day 1||||||
805525|NCT01004146|Secondary|Oxygen Saturation||one week prior to surgery up to one day after||||||
805526|NCT01004146|Secondary|Level of Compliance||3 days to 2 weeks after clinic visit on the day of surgery||||||
805527|NCT01004146|Primary|Post Operative Incentive Spirometry Volume|After the operation, the patients to be discharged on the same day were approached in the postanesthesia care unit (PACU) and requested to use the spirometer again. The volume (best out of 2 attempts) was recorded together with the same vital signs recorded preoperatively. Patients who were admitted to the hospital were requested to use the spirometer again on postoperative day 1. The largest IS volume (out of 2 attempts) was recorded. The data presented is the mean largest IS volume the day after surgery.|1 week before surgery to the day after|||cc||Standard Deviation|Mean
805530|NCT01004172|Secondary|Overall Survival|Overall survival is defined as the time from study entry to death or date last known alive and estimated using Kaplan-Meier (KM) methods.|Off treatment, participants were followed every 3 months for progression and overall survival. Duration of follow-up for this study cohort was up to 3 years.||09/2017||||
805531|NCT01004172|Secondary|Site of First Progression|Site of first progression was defined as progressive disease in either CNS or non-CNS sites by radiographic criteria.|Disease was evaluated radiologically at baseline and every 2 cycles on treatment. Off treatment, participants were followed every 3 months for progression and overall survival. Duration of follow-up for this study cohort approximated up to 3 years.|The analysis dataset is comprised of all enrolled and assessable participants.||participants|||Number
805532|NCT01004172|Secondary|CNS Best Response|"CNS best response was defined based on standard criteria. Adding to above CR and PR:
CNS stable disease (SD) is achieving all the following:
< 50% reduction in the volumetric sum of all measurable (>/= 1 cm in LD) brain metastases compared to baseline
No progression on non-measurable lesions
No new CNS lesions (defined as any new lesion >/= 6 mm in LD)
Stable or decreasing steroid dose
No new/progressive tumor-related neurologic signs or symptoms
No progression of extra-CNS disease as assessed by RECIST
CNS Progressive Disease (PD) was experiencing any of the following:
->/- 40% increase in the volumetric sum of all measurable (>/= 1 cm in LD) brain metastases compared to baseline
Progression on non-measurable lesions
New CNS lesions (defined as any new lesion >/= 6 mm in LD)
Increasing steroid dose
New/progressive tumor-related neurologic signs or symptoms
Progression of extra-CNS disease as assessed by RECIST"|Response was evaluated radiologically at baseline and every 2 cycles on treatment. Treatment duration for this study cohort was a median (range) of 8 cycles (1-20) which approximates months given the 4 week cycle length.|The analysis dataset is comprised of all enrolled and assessable participants.||Participants|||Count of Participants
805533|NCT01004172|Secondary|Progression-Free Survival|Progression-Free Survival (PFS) is defined as the duration of time from start of treatment to time of progression, second cancer, or death, whichever occurs first. PFS is estimated using Kaplan-Meier methods.|Disease was evaluated radiologically at baseline and every 2 cycles on treatment. Off treatment, participants were followed every 3 months for progression and overall survival. Duration of follow-up for this study cohort approximated up to 3 years.||09/2017||||
805534|NCT01004172|Primary|Central Nervous System (CNS) Objective Response Rate|"CNS objective response rate is the percentage of participants that achieve CNS complete or partial response as follows:
CNS complete response (CR) is achieved if all of the following are satisfied:
Complete resolution of all measurable (>= 1 cm in longest dimension [LD]) and non-measurable brain metastases
No new CNS lesions (defined as any new lesion >= 6 mm in LD)
Stable or decreasing steroid dose
No new/progressive tumor-related neurologic signs or symptoms
No progression of extra-CNS disease as assessed by RECIST
CNS partial response (PR) is achieved if all of the following are satisfied:
->/= 50% reduction in the volumetric sum of all measurable (>/= 1 cm in LD) brain metastases compared to baseline
No progression on non-measurable lesions
No new CNS lesions (defined as any new lesion >/= 6 mm in LD)
Stable or decreasing steroid dose
No new/progressive tumor-related neurologic signs or symptoms
No progression of extra-CNS disease as assessed by RECIST"|Response was evaluated radiologically at baseline and every 2 cycles on treatment. Treatment duration for this study cohort was a median (range) of 8 cycles (1-20) which approximates months given the 4 week cycle length.|The analysis dataset is comprised of all enrolled and assessable participants.||percentage of participants||95% Confidence Interval|Number
805535|NCT01004185|Secondary|Treatment Success PUCAI Amended Endpoint (5 Point Scale Abdominal Pain), mITT|PUCAI Score (0-85, sum of scores for each) abdominal pain (0/2.5/5/7.5/10 - no pain/very mild/mild/moderate/severe), rectal bleeding (0/10/20/30 - none, small amount <50% of stools, small amount most stools, large amount >50%), stool consistency (0/5/10 - formed, partially formed, completely formed), # stools/24 hrs. (0/5/10/15 - 0-2/3-5/6-8/>8), nocturnal bowel/any diarrhea causing wakening (0/10 - no/yes), activity level (0/5/10 - no limitation/occ limitation, severe restrictions). Remission <10, Mild 10-34, Moderate 35-64, Severe 65-85. Remission is Treatment Success.|Week 26|mITT Subjects who took at least one dose of study medication and did not have baseline stool examination positive for C. difficile, bacterial pathogens or ova/parasites.||percentage of participants|||Number
805536|NCT01004185|Primary|Treatment Success PUCAI (Pediatric Ulcerative Colitis Activity Index), mITT/Modified Intent to Treat Population|PUCAI Score (0-85, sum of scores for each): abdominal pain (0/5/10 - no pain/ignored/not ignored), rectal bleeding (0/10/20/30 - none, small amount <50% of stools, small amount most stools, large amount >50%), stool consistency (0/5/10 - formed, partially formed, completely formed), # stools/24 hrs. (0/5/10/15 - 0-2/3-5/6-8/>8), nocturnal bowel/any diarrhea causing wakening (0/10 - no/yes), activity level (0/5/10 - no limitation/occ limitation, severe restrictions). Remission <10, Mild 10-34, Moderate 35-64, Severe 65-85. Remission defined as Treatment Success.|Week 26|MITT subjects who took at least one dose of study medication and did not have baseline stool exam positive for C. difficile, bacterial pathogens or ova/parasites.||percentage of participants|||Number
805537|NCT01004250|Secondary|Percentage of Participants With Confirmed Complete Response or Partial Response During the Maintenance Therapy Only|CR and PR defined per RECIST Guidelines, Version 1.0. CR is disappearance of all tumor lesions. PR is either a) at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LDs, or b) complete disappearance of target lesions, with persistence (but not worsening) of 1 or more nontarget lesions. In either case, no new lesions may have appeared.|From the start of the maintenance to the first date of objectively determined PD during the maintenance therapy (assessment during maintenance treatment completed at every other cycle till PD and at 30 day follow-up)(Cycle 5 up to 104.1 Weeks)|"Participants qualified by the following criteria:
Confirmed histological or cytological diagnosis of nonsquamous Stage IIIB or Stage IV lung cancer
At least 1 unidimensionally measurable lesion
No concomitant curative anticancer therapy
Treated with at least one dose of study drug"||Percentage of Participants||95% Confidence Interval|Number
805548|NCT01004354|Secondary|Changes in the Baseline and Post-treatment Values of the Markers of the Metabolic Syndrome (Insulin, C-peptide, Fasting Blood Glucose, Homeostasis Model of Insulin Resistance (HOMA-IR), High Density Lipoprotein Cholesterol).||8 weeks||||||
805549|NCT01004354|Primary|Change in Weight||Baseline and 8 weeks|||kilograms||Standard Deviation|Mean
805550|NCT01004393|Secondary|Patient Satisfaction With the Study Medication After Administration of Subcutaneous Methylnaltrexone||48 hours after the dose of subcutaneous methylnaltrexone|||percentage of participants||95% Confidence Interval|Number
805538|NCT01004250|Secondary|Percentage of Participants With Confirmed Response Complete or Partial Response During the Induction Treatment Only|CR and PR defined per RECIST Guidelines, Version 1.0. CR is disappearance of all tumor lesions. PR is either a) at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LDs, or b) complete disappearance of target lesions, with persistence (but not worsening) of 1 or more nontarget lesions. In either case, no new lesions may have appeared.|From the time of study enrollment to the first date of objectively determined PD during the induction therapy (assessment during study treatment completed at every other cycle up to four cycles) (Baseline up to 4 cycles)|"Participants qualified by the following criteria:
Confirmed histological or cytological diagnosis of nonsquamous Stage IIIB or Stage IV lung cancer
At least 1 unidimensionally measurable lesion
No concomitant curative anticancer therapy
Treated with at least one dose of study drug"||Percentage of Participants||95% Confidence Interval|Number
805539|NCT01004250|Secondary|Percentage of Participants With Confirmed Complete Response or Partial Response During Study Treatment (Induction and Maintenance)|Overall Response Rate (ORR) is defined as the percentage of participants whose best response is complete response (CR) or partial response (PR) per RECIST Guidelines, Version 1.0. CR is disappearance of all tumor lesions. PR is either a) at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LDs, or b) complete disappearance of target lesions, with persistence (but not worsening) of 1 or more nontarget lesions. In either case, no new lesions may have appeared.|From enrollment to objectively determined PD (assessment during study treatment completed at every other cycle till PD and at 30 day follow-up)(Baseline up to 104.1 Weeks)|"Participants qualified by the following criteria:
Confirmed histological or cytological diagnosis of nonsquamous Stage IIIB or Stage IV lung cancer
At least 1 unidimensionally measurable lesion
No concomitant curative anticancer therapy
Treated with at least one dose of study drug"||Percentage of Participants||95% Confidence Interval|Number
805540|NCT01004250|Secondary|Overall Survival|Overall Survival (OS) is defined as the time from the date of study enrollment to the date of death from any cause. For participants not known to have died as of the data cut-off date, OS will be censored at the last contact date.|From enrollment to the date of death from any cause (every cycle during study treatment, every 6 weeks during follow-up period until PD, and then at least every 3 Months) (Baseline up to 36.3 Months)|32 participants were censored. All enrolled participants receiving at least one dose of study drug.||Months||95% Confidence Interval|Median
805541|NCT01004250|Primary|Progression-Free Survival|Progression-Free Survival (PFS) is defined as the time from the date of study enrollment to the first date of objectively determined PD or death from any cause. PD is defined using Response Evaluation Criteria in Solid Tumours (RECIST) Guidelines (Version 1.0), as at least a 20% increase in the sum of longest diameter (LD) of target lesions, taking as references the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions. For participants not known to have died as of the data cut-off date and who do not have objective PD, PFS will be censored at the date of the last objective progression-free disease assessment. For participants who receive subsequent systemic anticancer therapy, PFS will be censored at the date of the last objective progression-free disease assessment prior to post-discontinuation systemic therapy.|From enrollment to the first date of objectively determined Progressive Disease (PD) or death from any cause (every other cycle during study treatment and then every 6 weeks during follow-up period)(Baseline up to 36.1 Months)|"30 participants were censored. Participants qualified by the following criteria:
Confirmed histological or cytological diagnosis of nonsquamous Stage IIIB or Stage IV lung cancer
At least 1 unidimensionally measurable lesion
No concomitant curative anticancer therapy
Treated with at least one dose of study drug"||Months||90% Confidence Interval|Median
805542|NCT01004263|Primary|Number of Participants Discontinued From Study Due to AEs Occurring Within 14 Days Post Dose|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration. Participants who discontinued due to an AE occurring within 14 days post dose are counted in this summary.|Up to 14 days post dose|All enrolled participants who administered at least one dose of study medication||participants|||Number
805543|NCT01004263|Primary|Number of Participants Discontinued From Study Due to AEs Occurring Within 24 Hours Post Dose|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration. Participants who discontinued due to an AE occurring within 24 hours post dose are counted in this summary.|Up to 24 hours post dose|All enrolled participants who administered at least one dose of study medication||participants|||Number
805544|NCT01004263|Secondary|Percentage of Participant's Migraine Attacks With Pain Freedom at 2 Hours Post Dose|Pain intensity was assessed using a 5-Face Pain Scale ranging from 1=no pain to 5=very bad pain. Pain freedom (PF) was defined as a reduction in severity from a rating of 5, 4, 3 or 2 (mild, moderate or severe pain) before the dose to a rating of 1 (no pain) at 2 hours after dosing. Pain intensity ratings were reported in diaries returned at visits at 1, 2, 3, 4, 6, 9, and 12 months after Screening visit. PF at 2 hours was summarized as follows: the percentage of treated attacks with PF at 2 hours was calculated for each patient first, then the mean across all patients was calculated.|2 hours post dose|All participants who were enrolled and reported at least one treated migraine attack with at least one post treatment efficacy evaluation||percentage of participant's attacks||Standard Deviation|Mean
805545|NCT01004263|Primary|Number of Participants With AEs Within 14 Days Post Any Dose|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration. Participants reported AEs in a diary and these were collected by the study site at visits at 1, 2, 3, 4, 6, 9, and 12 months after Screening visit. AEs were assessed in a phone contact 14 days after the last dose of study medication. Participants with an AE occurring within 14 days after any dose administered during the study are counted once in this summary.|Up to 14 days post dose|All enrolled participants who administered at least one dose of study medication||participants|||Number
805546|NCT01004263|Primary|Number of Participants With Adverse Events (AEs) Within 24 Hours Post Any Dose|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration. Participants reported AEs in a diary and these were collected by the study site at visits at 1, 2, 3, 4, 6, 9, and 12 months after Screening visit. Participants with an AE occurring within 24 hours after any dose administered during the study are counted once in this summary.|Up to 24 hours post dose|All enrolled participants who administered at least one dose of study medication||participants|||Number
805558|NCT01004432|Secondary|Change in ESR-based DAS28 Score at Week 76 Relative to Week 52|Erythrocyte Sedimentation Rate (ESR)-based disease activity score for 28-joints count (DAS28) was calculated from number of swollen joint counts (SJC) and tender joint counts (TJC) using 28 joints count, ESR, and patient global assessment of disease activity (participant rated arthritis activity assessment with scores ranging 0 to 10; higher scores indicated greater disease activity). Total ESR-based DAS28 score range: 0 to 9.4, higher score=more disease activity.|Week 52, 76|Study extension mITT population. Here 'N' (number of participants analyzed) = participants evaluable for this measure and ‘n’ = participants evaluable at specified time point for each arm, respectively. Participants reported in other groups are subgroups of ‘Study Extension OL Group’ by treatment received in the OL/DB phase (Weeks 16-52).||units on a scale||Standard Deviation|Mean
805559|NCT01004432|Secondary|Percentage of Participants Who Achieved ESR-based and C-Reactive Protein (CRP)-Based ACR20 Response at Week 76 Relative to Week 16|Erythrocyte Sedimentation Rate (ESR)-based/ C Reactive Protein (CRP)-based ACR 20 response: >=20 % improvement from Week 16 in tender (68 joints assessed) and swollen (66 joints assessed) joint counts and >=20% improvement from Week 16 in 3 of the following 5 assessments: 1- Participant’s assessment of pain using VAS (0 to 10 cm), 2- Participant’s global assessment of disease activity using VAS (0 to 10 cm), 3- Physician’s global assessment of disease activity using VAS (0 to 10 cm), 4- Participant’s assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas), 5- ESR or CRP. Percentage of participants, who achieved ESR/ CRP-based ACR 20 responses at Week 76 relative to Week 16, is reported.|Week 76|Study extension mITT population included all participants, who were enrolled into the 24-week study extension period at Week 52, and received at least 1 golimumab SC injection during the study extension period. Participants reported in other groups are subgroups of ‘Study Extension OL Group’ by treatment received in the OL/DB phase (Weeks 16-52).||percentage of participants||95% Confidence Interval|Number
805560|NCT01004432|Secondary|Percentage of Participants Who Achieved Erythrocyte Sedimentation Rate (ESR)-Based ACR20 Response at Week 52 Relative to Week 16|Erythrocyte Sedimentation Rate (ESR)-based ACR 20 response: >=20 % improvement from Week 16 in tender (68 joints assessed) and swollen (66 joints assessed) joint counts and >=20% improvement from Week 16 in 3 of the following 5 assessments: 1- Participant’s assessment of pain using VAS (0 to 10 cm), 2- Participant’s global assessment of disease activity using VAS (0 to 10 cm), 3- Physician’s global assessment of disease activity using VAS (0 to 10 cm), 4- Participant’s assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas), 5- ESR. Percentage of participants, who achieved ESR-based ACR 20 responses at Week 52 relative to Week 16, is reported.|Week 52|Double-blind modified Intent To Treat (mITT) population included participants who were randomized at Week 16 to SC or IV golimumab (Groups 2a and 2b) and received at least 1 dose of study drug after randomization.||percentage of participants||95% Confidence Interval|Number
805561|NCT01004432|Secondary|Percentage of Participants Who Achieved Erythrocyte Sedimentation Rate (ESR)-Based Disease Activity Score (DAS28) Response at Week 16 and Maintained Response Through Week 52|Erythrocyte Sedimentation Rate (ESR)-based disease activity score for 28-joints count (DAS28) as defined by European League Against Rheumatism (EULAR), response criteria was used to assess individual response as none, moderate, or good, depending on the extent of change from Baseline and the level of disease activity reached. A participant was classified as having achieved a DAS28 good response if, DAS28 was less than or equal to (<=) 3.2 at a given visit and improvement from Baseline was >1.2. Percentage of participants, who achieved ESR-based DAS 28 good response at Week 16 and maintained that response through Week 52, is reported.|Week 52|Open-label modified Intent To Treat (mITT) population included all participants, who received at least 1 open-label golimumab 50 mg SC injection during the continued open-label/ double-blind treatment period.||percentage of participants||95% Confidence Interval|Number
805562|NCT01004432|Secondary|Percentage of Participants Who Achieved Erythrocyte Sedimentation Rate (ESR)-Based ACR20 Response at Week 2|Erythrocyte Sedimentation Rate (ESR)-based ACR 20 response: greater than or equal to (>=) 20 percent (%) improvement from Baseline in tender (68 joints assessed) and swollen (66 joints assessed) joint counts and >=20% improvement from Baseline in 3 of the following 5 assessments: 1- Participant’s assessment of pain using Visual Analog Scale (VAS) (0 to 10 centimeters [cm]), 2- Participant’s global assessment of disease activity using VAS (0 to 10 cm), 3- Physician’s global assessment of disease activity using VAS (0 to 10 cm), 4- Participant’s assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas), 5- ESR.|Within 2 weeks of initiating therapy|Modified Intent To Treat (mITT) population included all enrolled participants who had Week 0 measurements and received at least 1 dose of study drug.||percentage of participants||95% Confidence Interval|Number
805563|NCT01004432|Primary|Percentage of Participants Achieving Erythrocyte Sedimentation Rate (ESR)-Based American College of Rheumatology [ACR] 20 Response at Week 14|Erythrocyte Sedimentation Rate (ESR)-based ACR 20 response: greater than or equal to (>=) 20 percent (%) improvement from Baseline in tender (68 joints assessed) and swollen (66 joints assessed) joint counts and >=20% improvement from Baseline in 3 of the following 5 assessments: 1- Participant’s assessment of pain using Visual Analog Scale (VAS) (0 to 10 centimeters [cm]), 2- Participant’s global assessment of disease activity using VAS (0 to 10 cm), 3- Physician’s global assessment of disease activity using VAS (0 to 10 cm), 4- Participant’s assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas), 5- ESR.|Week 14|Modified Intent To Treat (mITT) population included all enrolled participants who had Week 0 measurements and received at least 1 dose of study drug.||percentage of participants||95% Confidence Interval|Number
805564|NCT01004510|Primary|Rate of Control (Lack of Need for Palliative Intervention of Malignant Pleural Effusions) in Patients With Non Small Cell Lung Cancer Treated With Standard Regimens of Cytotoxic Chemotherapy With the Addition of Zometa||3 months|Too few patients enrolled to analyze data|||||
805565|NCT01004614|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose|The PK parameter analysis set was defined as all subjects randomized and treated who completed the study.||hour||Full Range|Median
805648|NCT01004939|Primary|Duration of Fondaparinux Administration||4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010; n=101 participants with non-missing data.||days||Full Range|Median
805566|NCT01004614|Secondary|Mean Residence Time (MRT)|MRT = AUMCinf / AUCinf, where AUMCinf is the area under the first moment curve from zero time to infinity calculated as AUMCinf = AUMCt + ((t x Ct) / kel) + (Ct / kel^2). AUMCt is the area under the first moment curve from zero time to time t calculated using the trapezoidal method.|prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose|The PK parameter analysis set was defined as all subjects randomized and treated who completed the study.||hour||Standard Deviation|Mean
805567|NCT01004614|Secondary|Apparent Terminal Elimination Half-Life (T-half)|Terminal phase half-life calculated as ln(2) / kel|prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose|The PK parameter analysis set was defined as all subjects randomized and treated who completed the study.||hour||Standard Deviation|Mean
805568|NCT01004614|Secondary|Apparent Terminal Elimination Phase Rate Constant (Kel)|Estimated as the absolute value of the slope of a linear regression during the terminal phase of the natural-logarithm (ln) transformed concentration-time profile.|prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose|The PK parameter analysis set was defined as all subjects randomized and treated who completed the study.||L/h||Standard Deviation|Mean
805569|NCT01004614|Secondary|Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast), Area Under the Plasma Concentration-Time Curve to Infinity (AUCinf)|"AUC last = Area under the concentration versus time curve from zero time until the last measurable concentration is calculated using the trapezoidal rule.
AUCinf = AUClast + (Ct / kel), where Ct is the estimated concentration at the last measurable concentration."|prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose|The PK parameter analysis set was defined as all subjects randomized and treated who completed the study.||ng*h/mL||Standard Deviation|Mean
805570|NCT01004614|Primary|Maximum Observed Plasma Concentration (Cmax)||prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose|The PK parameter analysis set was defined as all subjects randomized and treated who completed the study.||ng/mL||Standard Deviation|Mean
805571|NCT01004614|Primary|Area Under the Concentration-Time Curve From Zero Time Until the Last Sampling Time (AUCt)|Area under the concentration-time curve from zero time until the last sampling time|prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose|The PK parameter analysis set was defined as all subjects randomized and treated who completed the study.||ng*h/mL||Standard Deviation|Mean
805572|NCT01004705|Secondary|The Difference in Mean Total Cholesterol Between the Basal and the Final Visit of Each Treatment Period.|Change from baseline in mean total cholesterol level following each Treatment Period was defined as the difference between the measurements from the baseline visit (Visit 4, Day 1) and Visit 9 (Day 84) for Treatment Period 1, and between the Visit 11 (Day 126) and Visit 16 (Day 210) for Treatment Period 2.|Day 1 and Day 84 of the Period 1 and Day 126 and Day 210 of Period 2|Per Protocol population||mg/dL||Standard Deviation|Mean
805573|NCT01004705|Primary|The Difference in LDL Cholesterol Levels Between the Basal and the Final Visit of Each Treatment Period.|Change from baseline in LDL cholesterol level following each Treatment Period was defined as the difference between the measurements from the baseline visit (Visit 4, Day 1) and Visit 9 (Day 84) for Treatment Period 1, and between the Visit 11 (Day 126) and Visit 16 (Day 210) for Treatment Period 2.|Day 1 and Day 84 of the Period 1 and Day 126 and Day 210 of Period 2|Per Protocol population||mg/dL||Standard Deviation|Mean
805574|NCT01004770|Primary|Radiographic Density of the Region of Interest (ROI) Between Pre and Post Contrast Image|Radiographic Density differences of the abdominal aorta, pre and post contrast on the Arterial Phase|Pre and post contrast administration|Per Study Protocol||Hounsfield Units||Standard Deviation|Mean
805575|NCT01004770|Primary|12-Lead Electrocardiogram (ECG) Values|12-Lead ECG values taken up to and including 24 hours|Baseline and up to and including 24 hours post contrast administration|Per Study Protocol||QTcB (msec)||Standard Deviation|Mean
805576|NCT01004770|Primary|Vital Sign (Heart Rate in Beats Per Minute-(Bpm)) Values|Heart Rate (beats per minute-(bpm)) taken up to and including 8 hours.|Baseline and up to and including 8 hours post contrast administration|Per Study Protocol||> 10 beats per minute (bpm)||Standard Deviation|Mean
805577|NCT01004770|Primary|Vital Signs (Blood Pressure) Systolic and Diastolic Values|Systolic and Diastolic bolld pressure taken up to and including 8 hours|Baseline and up to and including 8 hours post contrast administation.|Per Study Protocol||mm Hg||Standard Deviation|Mean
805578|NCT01004770|Primary|Blood Urea Nitrogen and Creatinine Serum Values|Blood Urea Nitrogen and Creatinine serum value results taken up to and including 72 hours.|Baseline and up to and including 72 hours post contrast administration|Per Study Protocol||mg/dL||Standard Deviation|Mean
805579|NCT01004822|Secondary|Participants With Reduction in Tumor Vascular Permeability: Blood Flow and Blood Volume as Measured by Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI)|DCE-MRI is a non-invasive method that provides a functional assessment of microvasculature. The technique can measure changes in vascular permeability, extracellular, and extravascular and vascular volumes. Based on its ability to detect vascular changes, DCE-MRI has recently been evaluated as a biomarker of drug efficacy in clinical trials of angiogenesis inhibitors. Assessment of DCE-MRI started at the 3.0 mg/kg dose cohort.|Stage 2 predose up to end of study|Results are not reported for this measure, as, none of the participants could reach out to Stage 2 due to discontinuations of all the participants in Stage 1.|||||
805580|NCT01004822|Secondary|Participants WithTumor Response of CA-125 Epithelial Ovarian Cancer (EOC)/ Primary Peritoneal Cancer (PPC)|Participants with epithelial ovarian cancer or primary peritoneal cancer having CA-125 levels greater than 2x the upper limit of normal, 2 weeks prior to starting therapy were evaluated for CA-125 response and response is defined as a 50% decrease in CA-125 from a pre-treatment sample. The response was confirmed and maintained for at least 28 days. CA-125 response was calculated as intervening samples and the 28-day confirmatory sample must be less than or equal to (within assay variability of 10%) the previous sample Progression or recurrence based on serum CA-125 is defined according to the participants baseline levels.|Stage 2 every cycle|Results are not reported for this measure, as, none of the participants could reach out to Stage 2 due to discontinuations of all the participants in Stage 1.|||||
805631|NCT01004939|Secondary|Duration of All Hospitalizations Under UFH, LMWH, and Fondaparinux Administration||4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010; n=9 participants with non-missing data.||days||Full Range|Median
805581|NCT01004822|Secondary|Objective Response Rate - Percentage of Participants With Objective Response|Percentage of participants with objective response based assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1). CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short aixs was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. Stable disease was defined as not qualifying for CR, PR, and Progressive Disease.|Every 8 weeks from start of treatment until last dose of study medication (last dose = up to Cycle 39)|Safety analysis set included all randomized participants who received at least one dose of study medication. Data for Stage 2 is not reported due to early termination of the study.||percentage of participants|||Number
805582|NCT01004822|Secondary|Number of Anti Drug Antibody Samples With Positive Anti-CVX-241 Antibodies|Results were summarized for overall study population as per planned analysis.|Day 1 pre-dose of each cycle up to last dose of study medication (last dose = up to Cycle 39)|Safety analysis set included all randomized participants who received at least one dose of study medication. Data for Stage 2 is not reported due to early termination of the study.||samples|||Number
805583|NCT01004822|Secondary|Change From Baseline in Serum Angiopoietin-2 (Ang2) Concentrations|Angiopoietin-2 (Ang2) and a related protein, angiopoietin-1 (Ang1) are ligands of the endothelial cell receptor Tie-2, a receptor tyrosine kinase, and are known to mediate the angiogenesis process together with VEGF and other angiogenic regulators. Ang1 stimulates the phosporylation of Tie-2, recruits pericytes to newly formed blood vessels, and promotes their maturation. Ang2 competes with Ang1 for binding of Tie-2, promotes the dissociation of pericytes, and results in unstable blood vessels. In the presence of VEGF and other angiogenic factors, endothelial cells in these unstable vessels proliferate and migrate to form new blood vessels.|Cycle 1/Day 1, Cycle 1/Day 5, Cycle 1/Day 8, Cycle 1/Day 15, Cycle 1/Day 22, Cycle 2/Day 1|"Safety analysis set included all randomized participants who received at least one dose of study medication. Here n signifies those participants who were evaluable for this measure at specified time points for each arm, respectively. Data for Stage 2 is not reported due to early termination of the study."||pg/mL||Standard Deviation|Mean
805584|NCT01004822|Secondary|Change From Baseline in Plasma Vascular Endothelial Growth Factor (VEGF) Concentrations|VEGF family consists of five glycoproteins known as VEGF-A, -B, -C, and -D, and placental growth factor (PlGF), which bind to three structurally similar receptor tyrosine kinases VEGFR1, VEGFR2, and VEGFR3. The different ligands have distinctive binding specificities for each of the receptors. In response to ligand binding, the VEGFRs activate distinct downstream signalling pathways. VEGFR2 is expressed in the vasculature and is the key mediator of VEGF-induced angiogenesis.|Cycle 1/Day 1, Cycle 1/Day 5, Cycle 1/Day 8, Cycle 1/Day 15, Cycle 1/Day 22, Cycle 2/Day 1|"Safety analysis set included all randomized participants who received at least one dose of study medication. Here n signifies those participants who were evaluable for this measure at specified time points for each arm, respectively. Data for Stage 2 is not reported due to early termination of the study."||picogram/milliliter (pg/mL)||Standard Deviation|Mean
805585|NCT01004822|Secondary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Study drug was analysed using serum Angiopoietin-2 (Ang2) and plasma Vascular Endothelial Growth Factor (VEGF).|Pre-dose, 1, 2, 4, 6 hours post dose at Day 1 of cycle 1|Safety analysis set included all randomized participants who received at least one dose of study medication. Data for Stage 2 is not reported due to early termination of the study.||hours||Standard Deviation|Mean
805586|NCT01004822|Secondary|Systemic Clearance (CL)|CL is a quantitative measure of the rate at which a drug substance is removed from the body. Due to premature termination of the study, only certain exposure-related noncompartmental PK parameters were calculated.|Pre-dose, 1, 2, 4, 6 hours post dose at Day 1, Day 22 of cycle 1|Due to premature termination of the study, CL data were not calculated, only certain pre-specified exposure related non compartmental pharmacokinetics (PK) parameters were calculated.|||||
805587|NCT01004822|Secondary|Minimum Observed Plasma Trough Concentration (Cmin)||Pre-dose, 1, 2, 4, 6 hours post dose at Day 1, Day 22 of cycle 1|Due to premature termination of the study Cmin data were not calculated, only certain pre-specified exposure related non compartmental pharmacokinetics (PK) parameters were calculated.|||||
805588|NCT01004822|Secondary|Maximum Observed Plasma Concentration (Cmax)|Study drug was analysed using serum Angiopoietin-2 (Ang2) and plasma Vascular Endothelial Growth Factor (VEGF).|Pre-dose, 1, 2, 4, 6 hours post dose at Day 1, Day 22 of cycle 1|"Safety analysis set included all randomized participants who received at least one dose of study medication. Here n signifies those participants who were evaluable for this measure at specified time points for each arm, respectively. Data for Stage 2 is not reported due to early termination of the study."||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
805589|NCT01004822|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf]|AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞)u for unbound drug. It is obtained from AUC (0 - t)u plus AUC (t - ∞)u for unbound drug. Study drug was analysed using serum Angiopoietin-2 (Ang2) and plasma Vascular Endothelial Growth Factor (VEGF).|Pre-dose, 1, 2, 4, 6 hours post dose at Day 1 of cycle 1|"Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here n signifies those participants who were evaluable for this measure at specified time points for each arm, respectively. Data for Stage 2 is not reported due to early termination of the study."||nanogram*hours per milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
805615|NCT01004939|Secondary|Duration From Start of Fondaparinux Therapy to HIT|For the 1 participant who developed HIT after receiving Fondaparinux, the number of days from start of therapy to HIT is presented.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010. Only one participant developed HIT after receiving Fondaparinux; thus, rather than presenting median data, data are presented as the number of days from start of therapy to HIT.||days|||Number
806271|NCT01012167|Secondary|Laboratory Measures - Calcium|Calcium blood levels by treatment group and visit.|Once during evaluation and once at the end of 6 weeks of study treatment|Available participant lab data at Evaluation and Week 6.||mg/dL||Standard Deviation|Mean
805590|NCT01004822|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs)|Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included SAEs and non-SAEs that occurred during the study.|Baseline up to 28 days after last dose of study medication (last dose = up to Cycle 39)|Safety analysis set included all randomized participants who received at least 1 dose of study medication. Data for Stage 2 is not reported due to early termination of the study.||participants|||Number
805591|NCT01004822|Secondary|Number of Participants With Dose Limiting Toxicities (DLTs)|DLT was defined as any of the following events occurring during the first 28 days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 clinically-relevant non-hematologic toxicity, any clinically-significant grade 2 non-hematologic toxicity that requires 14 days to resolve (to grade 1).|Stage 1: Baseline up to Week 4|Safety analysis set included all randomized participants who received at least 1 dose of study medication.||participants|||Number
805592|NCT01004822|Primary|Recommended Phase 2 Dose (RP2D)|RP2D was the highest dose where 0 of 3 or less than (<2) out of 6 participants experience a DLT. DLT was defined as any of the following events occurring during the first 28 days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 clinically-relevant non-hematologic toxicity, any clinically-significant grade 2 non-hematologic toxicity that requires 14 days to resolve (to grade 1).|Stage 1: Baseline up to Day 28 (end of cycle 1)|Safety analysis set included all randomized participants who received at least 1 dose of study medication. Due to premature termination of the study RP2D could not be assessed.|||||
805593|NCT01004822|Primary|Maximum Tolerated Dose (MTD)|MTD was defined as highest dose level for which no more than 1 participant in a dose cohort experienced dose limiting toxicity (DLT). DLT was defined as any of the following events occurring during the first 28 days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 clinically-relevant non-hematologic toxicity, any clinically-significant grade 2 non-hematologic toxicity that requires 14 days to resolve (to grade 1).|Stage 1: Baseline up to Day 28 (end of cycle 1)|Safety analysis set included all randomized participants who received at least 1 dose of study medication. Due to premature termination of the study MTD could not be assessed.|||||
805594|NCT01004848|Secondary|Knowledge & Attitudes About Diabetes Risk||6 months||||||
805595|NCT01004848|Secondary|Physical Activity (Self-report)||6 months||||||
805596|NCT01004848|Secondary|Fiber Intake||Change from Baseline to 6 Months|||grams per day||Standard Deviation|Mean
805597|NCT01004848|Secondary|Energy Expenditure|percent energy expenditure|Change from Baseline to 6 Months|||percent expenditure/day||Standard Deviation|Mean
805598|NCT01004848|Secondary|HbA1c||Change from Baseline to 6 Months|||percent change||Standard Deviation|Mean
805599|NCT01004848|Secondary|Triglycerides||Change from Baseline to 6 Months|||mg/dl||Standard Deviation|Mean
805600|NCT01004848|Secondary|Total Cholesterol||Change from Baseline to 6 Months|||mg/dl||Standard Deviation|Mean
805601|NCT01004848|Secondary|HDL Cholesterol||Change from Baseline to 6 Months|||mg/dl||Standard Deviation|Mean
805602|NCT01004848|Secondary|LDL Cholesterol||Change from Baseline to 6 Months|||mg/dl||Standard Deviation|Mean
805603|NCT01004848|Secondary|Waist Circumference||Change from Baseline to 6 Months|||inches||Standard Deviation|Mean
805604|NCT01004848|Secondary|Change in Diastolic Blood Pressure From Baseline to 6 Months||Change from Baseline to 6 Months|||mmHg||Standard Deviation|Mean
805605|NCT01004848|Secondary|Change in Systolic Blood Pressure From Baseline to 6 Months||Change from Baseline to 6 Months|||mmHg||Standard Deviation|Mean
805606|NCT01004848|Secondary|Change in Post-prandial Fingerstick Glucose From Baseline to 6 Months|Change in sugar level as measured from fingerstick after a meal, at 6 Months as compared to Baseline|Change in 6 Months from Baseline|||mg/dL||Standard Deviation|Mean
805607|NCT01004848|Secondary|Change in Fasting Fingerstick Glucose Measurement From Baseline to 6 Months|Change in sugar level as measured from fingerstick, at 6 Months as compared to Baseline|Change from Baseline to 6 Months|||mg/dL||Standard Deviation|Mean
805608|NCT01004848|Primary|Change in Weight From Baseline to 6 Months||Change from Baseline to 6 Months|||pounds||Standard Deviation|Mean
805609|NCT01004874|Secondary|Median Progression-free Survival|PFS was defined as time in months from the start of study treatment to the date of first progression according to Macdonald criteria, or to death due to any cause. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve.|27 months|Intent to treat||months||95% Confidence Interval|Median
805610|NCT01004874|Secondary|Number of Patients Experiencing a Greater Than or Equal to Grade 4 Hematologic or a Greater Than or Equal to Grade 3 Non-hematologic Toxicity|Number of times a grade ≥4 hematologic or grade ≥3 non-hematologic toxicity was experienced|27 months|Intent to treat||participants|||Number
805611|NCT01004874|Secondary|Number of Patients Experiencing a Central Nervous System (CNS) Hemorrhage or a Systemic Hemorrhage|Number of times a CNS hemorrhage or systemic hemorrhage was experienced|27 months|Intent to treat||participants|||Number
805612|NCT01004874|Secondary|Median Overall Survival|OS was defined as time in months from the start of study treatment to date of death due to any cause. Patients alive as of the last follow-up had OS censored at the last follow-up date. Median OS was estimated using a Kaplan-Meier curve.|27 months|Intent to treat||months||95% Confidence Interval|Median
805613|NCT01004874|Secondary|One and Two Year Overall Survival|Time in months from the start of study treatment to date of death due to any cause. Patients alive as of the last follow-up had OS censored at the last follow-up date.|One year and two years|Intent to treat||percentage of participants||95% Confidence Interval|Number
805614|NCT01004874|Primary|6-month Progression-free Survival|Percentage of participants surviving six months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to the Macdonald criteria, or to death due to any cause.|6 months|Intent to treat||percentage of participants||95% Confidence Interval|Number
805616|NCT01004939|Secondary|Number of Participants With Heparin-induced Thrombocytopenia (HIT II) Under Fondaparinux Therapy|The participant with HIT II was pretreated with LMWH; however, the serious adverse event of HIT II was documented after the participant switched to Fondaparinux treatment.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010||participants|||Number
805617|NCT01004939|Secondary|Number of Participants With Skin Changes Under Fondaparinux Therapy|No formal definition for skin change was predetermined; documentation was based on the investigators’ individual assessment.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010||participants|||Number
805618|NCT01004939|Secondary|Number of Participants With Bleedings Under Fondaparinux Therapy|No formal definition for bleeding was predetermined; documentation was based on the investigators’ individual assessment.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010||participants|||Number
805619|NCT01004939|Secondary|Number of Participants With Thromboembolisms Under Fondaparinux Therapy|Any sign of thromboembolism as indicated by investigator was measured.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010||participants|||Number
805620|NCT01004939|Secondary|Number of Participants With and Without Complications Under Fondaparinux Therapy|A complication is defined as any thromoemolism, bleeding, skin change, HIT, amputation, death, or other complication (as indicated by investigator).|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010||participants|||Number
805621|NCT01004939|Secondary|Duration From Start of UFH/LMWH Therapy to HIT||4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010; n=8 participants with non-missing data.||days||Full Range|Median
805622|NCT01004939|Secondary|Number of Participants With Heparin-induced Thrombocytopenia (HIT II) Under UFH/LMWH Therapy|HIT II is characterized as a sudden decrease of thrombocyte count because of allergic response on heparin/platelet factor 4 (PF-4) complexes and is a severe and potentially fatal side effect of heparins. Usually, HIT occurs between Day 5 and Day 14 of exposure to UFH or LMWH.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010||participants|||Number
805623|NCT01004939|Secondary|Number of Participants Who Exhibited Observed Skin Changes and Also Had Skin Necrosis Associated With the Skin Changes Under UFH/LMWH Therapy|Skin necrosis is defined as the dying off of skin area because of allergic reaction. Skin necrosis is a severe side effect of heparins.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010. Only participants exhibiting skin changes are included in this analysis.||participants|||Number
805624|NCT01004939|Secondary|Number of Participants Who Exhibited Observed Skin Changes and Also Had Erythema Associated With the Skin Changes Under UFH/LMWH Therapy|Erythema is defined as inflammation of the skin, associated with reddening, and is a frequent side effect of heparins.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010. Only participants exhibiting skin changes are included in this analysis.||participants|||Number
805625|NCT01004939|Secondary|Duration From Start of UFH/LMWH Therapy to Skin Change|No formal definition for skin change was predetermined; documentation was based on the investigators’ individual assessment.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010; n=27 participants with non-missing data.||days||Full Range|Median
805626|NCT01004939|Secondary|Number of Participants With Skin Changes Under UFH/LMWH Therapy|No formal definition for skin change was predetermined; documentation was based on the investigators’ individual assessment.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010||participants|||Number
805627|NCT01004939|Secondary|Number of Participants With Bleedings Under UFH/LMWH Therapy|No formal definition for bleeding was predetermined; documentation was based on the investigators’ individual assessment.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010||participants|||Number
805628|NCT01004939|Secondary|Number of Participants With Thromboembolisms Under UFH/LMWH Therapy|Any sign of thromboembolism as indicated by investigator was measured.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010||participants|||Number
805629|NCT01004939|Secondary|Number of Participants With Complications Under UFH/LMWH Therapy|A complication is defined as any thromoemolism, bleeding, skin change, HIT, amputation, or other complication (as indicated by investigator).|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010||participants|||Number
805630|NCT01004939|Secondary|Duration of Hospitalizations Before, During, and After Fondaparinux Administration||4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010; n=3 participants (before Fondaparinux), n=5 participants (during Fondaparinux), and n=1 participant (after Fondaparinux) with non-missing data.||days||Full Range|Median
805632|NCT01004939|Secondary|Number of Participants Hospitalized Because of Thromboembolic Treatment|Thromboembolic treatment is a defined as prophylaxis for an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010||participants|||Number
805633|NCT01004939|Primary|Number of Newborns With Abnormalities|No formal definition for abnormalities was predetermined; documentation was based on the investigators’ individual assessment.|4 months (all cases occurred between 2004 and 2010)|Newborns of pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010||newborns|Participants||Number
805634|NCT01004939|Primary|Number of Newborns Who Had a “Healthy” Postnatal Classification|A “healthy” documentation was based on the investigators’ individual assessment.|4 months (all cases occurred between 2004 and 2010)|Newborns of pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010. A total of 124 newborns were born to 120 women; 4 women bore twins.||newborns|Participants||Number
805635|NCT01004939|Primary|Mean APGAR Score at 1, 5, and 10 Minutes After Birth|APGAR is a test performed by a doctor, midwife, or nurse at 1 and 5 minutes after birth. The 1-minute score determines how well the baby tolerated the birthing process; the 5-minute score assesses how well the newborn is adapting to the new environment. The health care provider examines the baby's breathing effort, heart rate, muscle tone, reflexes, and skin color. Each category is scored with 0 (worst score), 1, or 2 (best score), depending on the observed condition. The rating is based on a total score of 1-10, with 10 suggesting the healthiest infant.|4 months (all cases occurred between 2004 and 2010)|Newborns of pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010. A total of 124 newborns were born to 120 women; 4 women bore twins. n=26 (1 min) or n=27 (5 and 10 min) newborns with non-missing data.||scores on a scale|Participants|Standard Deviation|Mean
805636|NCT01004939|Primary|Mean Head Circumference of Newborn||4 months (all cases occurred between 2004 and 2010)|Newborns of pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010. A total of 124 newborns were born to 120 women; 4 women bore twins. n=27 newborns with non-missing data.||centimeters|Participants|Standard Deviation|Mean
805637|NCT01004939|Primary|Mean Height of Newborn||4 months (all cases occurred between 2004 and 2010)|Newborns of pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010. A total of 124 newborns were born to 120 women; 4 women bore twins. n=37 newborns with non-missing data.||centimeters|Participants|Standard Deviation|Mean
805638|NCT01004939|Primary|Mean Weight of Newborn||4 months (all cases occurred between 2004 and 2010)|Newborns of pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010. A total of 124 newborns were born to 120 women; 4 women bore twins. n=63 newborns with non-missing data.||grams|Participants|Standard Deviation|Mean
805639|NCT01004939|Primary|Number of Participants Who Delivered a Single Child Versus Twins||4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010||participants|||Number
805640|NCT01004939|Primary|Number of Participants With the Indicated Type of Conception/Fertilization||4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010||participants|||Number
805641|NCT01004939|Primary|Number of Participants With the Indicated Outcome of Pregnancy by Type of Birth||4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010||participants|||Number
805642|NCT01004939|Primary|Number of Participants With the Indicated Reason for the End of Fondaparinux Administration|It is possible that a participant stopped receiving Fondaparinux for multiple reasons.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010||participants|||Number
805643|NCT01004939|Primary|Number of Hours After Birth at Which Fondaparinux Administration Was Restarted||4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010; n=86 participants with non-missing data.||hours||Standard Deviation|Mean
805644|NCT01004939|Primary|Number of Hours Before Birth That the Last Fondaparinux Dose Was Administered||4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010; n=45 participants with non-missing data.||hours||Standard Deviation|Mean
805645|NCT01004939|Primary|Number of Participants for Whom Fondaparinux Administration Was Interrupted for Birth||4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010||participants|||Number
805646|NCT01004939|Primary|Duration of Postnatal Fondaparinux Administration|The postnatal interval is defined as the interval of time beginning 2 days after birth.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010; n=90 participants with non-missing data.||days||Full Range|Median
805647|NCT01004939|Primary|Duration of Prenatal Fondaparinux Administration|The prenatal interval is defined as the interval of time until 3 days before birth.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010; n=99 participants with non-missing data.||days||Full Range|Median
805649|NCT01004939|Primary|Number of Participants Administered the Indicated Dose of Fondaparinux Per Day||4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010||participants|||Number
805650|NCT01004939|Primary|Number of Participants With the Indicated Reason for Change to Fondaparinux|It was possible for a participant to have changed to fondaparinux for multiple reasons.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010||participants|||Number
805651|NCT01004939|Primary|Number of Participants Receiving Fondaparinux in the Indicated Therapy Intervals|The prenatal interval is defined as the interval of time until 3 days before birth. The perinatal interval is defined as the interval of time from 2 days before birth to one day after birth. The postnatal interval is defined as the interval of time beginning 2 days after birth.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010||participants|||Number
805652|NCT01004991|Primary|Complete Response|Complete Response|13 months|||Participants|||Count of Participants
805653|NCT01005251|Secondary|Absolute Change From Baseline to Treatment Period in Percent Days With at Most Mild GERD Symptoms.|"Symptom intensity rated by participants twice daily on a six-graded Likert scale (Did not have; Very mild; Mild; Moderate; Moderately severe; Severe) using an electronic Reflux Symptom Questionnaire diary
(GERD = Gastroesophageal Reflux Disease)"|The 7 days before randomisation (baseline) and during 26-30 days of treatment|||Percent||Inter-Quartile Range|Median
805654|NCT01005251|Primary|Number of Participants With a Change in GERD Symptoms Corresponding to at Least Three More Days of Not More Than Mild Symptoms on Average Per Week During Treatment (Approximately 4 Weeks) Than During Baseline (the 7 Days Before Randomisation)|"Symptom intensity rated by participants twice daily on a six-graded Likert scale (Did not have; Very mild; Mild; Moderate; Moderately severe; Severe) using an electronic Reflux Symptom Questionnaire diary.
(GERD = Gastroesophageal Reflux Disease)"|The 7 days before randomisation (baseline) and during 26-30 days of treatment|||Participants|||Number
805655|NCT01005290|Secondary|Difference in the Adjusted Mean 24-h Diastolic Pressure Results Between the Basal and the Final Visit of Each Treatment Period|Difference in the Adjusted Mean 24-h Diastolic Pressure Results (Using ABPM) Between the Basal and the Final Visit of Each Treatment Period|Days 7 and 36 of Period 1 and days 49 and 85 of Period 2|The PP set included all randomized subjects who received at least one dose of IMP, had a baseline primary endpoint measurement, had at least one post baseline primary endpoint measurement, and who had no major protocol deviations. The PP set served as the primary analysis set for analysis of the primary endpoint.||mm Hg||Standard Deviation|Mean
805656|NCT01005290|Primary|Difference in the Adjusted Mean 24-h Systolic Pressure Results (Using ABPM) Between the Basal and the Final Visit of Each Treatment Period.|Difference in the adjusted mean 24-h systolic pressure results using ABPM (Ambulatory Blood Pressure Monitoring)in the PP population.|Days 7 and 36 of Period 1 and days 49 and 85 of Period 2|The PP set included all randomized subjects who received at least one dose of IMP, had a baseline primary endpoint measurement, had at least one post baseline primary endpoint measurement, and who had no major protocol deviations. The PP set served as the primary analysis set for analysis of the primary endpoint.||mm Hg||Standard Deviation|Mean
805657|NCT01005316|Secondary|Time to Acute Rejection|Time (in days) to acute rejection. Acute rejection is defined as any one of the following types of rejection: acute cellular rejection (International Society for Heart and Lung Transplant (ISHLT) system for grading rejection grade 2R or greater), acute refractory cellular rejection (acute cellular rejection unresponsive to two sequential courses of corticosteroids), acute antibody mediated rejection (histological evidence of unequivocal acute capillary injury, with complement deposition and margination of macrophages with or without neutrophils), acute mixed rejection (evidence of acute antibody mediated rejection with ISHLT grade 1R or greater), or acute clinical rejection (clinically-based acute rejection, no matter the ISHLT grade, leading to an acute augmentation of immunosuppression). Time to acute rejection is time from transplantation to first acute rejection date.|Transplantation to the end of study.|Transplanted Participants||Days||Full Range|Mean
805658|NCT01005316|Secondary|Percentage of Participants Experiencing Acute Rejection|Acute rejection is defined as any one of the following types of rejection: acute cellular rejection (International Society for Heart and Lung Transplant (ISHLT)) system for grading rejection grade 2R or greater), acute refractory cellular rejection (acute cellular rejection unresponsive to two sequential courses of corticosteroids), acute antibody mediated rejection (histological evidence of unequivocal acute capillary injury, with complement deposition and margination of macrophages with or without neutrophils), acute mixed rejection (evidence of acute antibody mediated rejection with ISHLT grade 1R or greater), or acute clinical rejection (clinically-based acute rejection, no matter the ISHLT grade, leading to an acute augmentation of immunosuppression).|Transplantation to the end of study.|Transplanted Participants||percentage of participants|||Number
805659|NCT01005316|Secondary|Time to New-Onset Diabetes Mellitus|Time (in days) to new-onset diabetes mellitus. New-onset diabetes mellitus is defined as the new onset of insulin dependency or the need for oral hypoglycemic agents lasting more than 30 days post-transplant. Time to new-onset diabetes is time from transplantation until the diagnosis of new-onset diabetes.|Transplantation to the end of study (up to 4 years post transplant).|Transplanted Participants. Note to provide relevant outcome measure perspective -Of the overall number of participants analyzed, the number of new onset diabetes mellitus cases diagnosed within groups were: Cohort A: Non-Sensitized (N=1); Cohort B: Sensitized, Crossmatch Positive (N=2); and Cohort B: Sensitized, Crossmatch Negative (N=7).||Days||Full Range|Mean
805660|NCT01005316|Secondary|Time to Post-Transplantation Lymphoproliferative Disorder|Time (in days) post-transplant lymphoproliferative disorder (PTLD). PTLD is defined as histopathological evidence of lymphoid proliferation (nodal or extranodal) fulfilling the criteria of the revised classification of the WHO 2008 (Swerdlow 2008). Time to PTLD is time from transplantation until the diagnosis of PTLD.|Transplantation to the end of study (up to 4 years post transplant).|Transplanted Participants. Note to provide relevant outcome measure perspective- Of the overall number of participants analyzed, the number of diagnosed PTLD cases within groups were: Cohort A: Non-Sensitized (N=1); Cohort B: Sensitized, Crossmatch Positive (N=0); and Cohort B: Sensitized, Crossmatch Negative (N=3).||Days||Full Range|Mean
805661|NCT01005316|Secondary|Time to Diagnosis of Chronic Rejection|Time (in days) to the diagnosis of chronic rejection. Chronic rejection is defined as stenosis, irregularity, or ectasia of the epicardial vessels, or severe peripheral pruning of the distal coronary artery tree. Time to diagnosis is time from transplantation until the first diagnosis of chronic rejection.|Transplantation to the end of study (up to 4 years post transplant).|Transplanted Participants||Days||Full Range|Mean
805662|NCT01005316|Secondary|Percentage of Participants Positive for Severe Infection(s)|Severe infections are defined as a clinical illness considered likely infectious in origin that leads to hospitalization.|Transplantation to the end of study (up to 4 years post transplant).|Transplanted Participants||percentage of participants|||Number
805663|NCT01005316|Secondary|Percentage of Participants With Occurrence of Re-Hospitalization(s)|Hospitalization is defined as any hospitalization lasting greater than 24 hours.|Transplantation to the end of study (up to 4 years post transplant).|Transplanted Participants||percentage of participants|||Number
805664|NCT01005316|Secondary|Presence of C4d on Endomyocardial Biopsy (EMB)|The biopsy of the heart stained positive for the presence of C4d, a potential marker of rejection.|Transplantation to the end of study (up to 4 years post transplant).|Transplanted Participants||percentage of participants|||Number
805665|NCT01005316|Secondary|Percentage of Participants -Overall Participant and Graft Survival|This measure looks at the participants who did not die and/or did not receive a subsequent heart transplant.|Transplantation to the end of study (up to 4 years post transplant).|Transplanted Participants||percentage of participants|||Number
805666|NCT01005316|Secondary|Percentage of Participants With the Presence of Anti-MICA Antibodies by Luminex TM Assay|Major histocompatibility complex class I chain-related gene A (MICA) is an antigen that is a potential marker of rejection. Luminex TM assay was used to detect its presence.|Pre-Transplantation|Transplanted Participants||percentage of participants|||Number
805667|NCT01005316|Secondary|Percentage of Participants -Quantification of Anti-HLA IgG Antibodies by Luminex SA Testing|Quantification of anti-HLA IgG antibodies is measured in mean fluorescence intensity (MFI). The maximum MFI for the given subject is provided.|Pre-transplantation|Transplanted Participants||percentage of participants|||Number
805668|NCT01005316|Secondary|Percentage of Participants With the Presence of Anti-HLA IgG Antibodies by Luminex SA Testing|Luminex SA testing was used to detect the presence of anti-HLA IgG Antibodies for all samples at a central laboratory.|Pre-transplantation|Transplanted Participants||percentage of participants|||Number
805669|NCT01005316|Secondary|Time From Participant Listing on Organ Wait-List to Receiving Organ Transplant, Death or De-Listing|Time (in days) from listing on the organ wait-list to receiving an organ transplant, death or de-listing. This measure is calculated as time from listing on the organ wait-list until the earliest time among transplantation, death and de-listing.|Study enrollment to transplantation|Enrolled participants who died, were transplanted or de-listed.||Days||Full Range|Mean
805670|NCT01005316|Secondary|Percentage of Participants- Mortality While on Transplantation Wait-List|Death that occurred while on the transplantation wait-list, and thus before receiving a heart transplant.|Pre-transplantation|Participants Enrolled, Not Transplanted||percentage of participants|||Number
805671|NCT01005316|Secondary|Percentage of Participants Positive for de Novo Donor-Specific Alloantibody Production in the First Year Post-Transplantation|A de novo donor-specific alloantibody (DSA) is a newly developed alloantibody that is against the donor organ. This measure includes all de novo DSA (≥1000 MFI) regardless of is persistence or timing within the first year post-transplant. Alloantibodies are important mediators of acute and chronic rejection.|Transplantation to first year post transplant (up to 12 months post transplant).|Transplanted Participants||percentage of participants|||Number
805672|NCT01005316|Secondary|Time to Production of Post-Transplant de Novo Donor-specific Alloantibodies|Time (in days) from transplant to development of de novo donor-specific alloantibodies (DSA). This measure is calculated as time from transplant until the earliest time of development of any de novo DSA. The DSA is a newly developed alloantibody that is against the donor organ. Alloantibodies are important mediators of acute and chronic rejection.|Transplantation to first year post transplant (up to 12 months post transplant).|Transplanted Participants||Days||Full Range|Mean
805673|NCT01005316|Primary|Percentage of Participants Positive for Event of Death, Graft Loss or Rejection With Hemodynamic Compromise at 12 Months Post-Transplantation|"This is a composite outcome of death, graft loss or rejection with hemodynamic compromise.
Rejection was considered to be with hemodynamic compromise if the rejection event had new onset echocardiographically measured from fractional shortening <26% with ≥5% fall from last echocardiogram or the rejection event had new onset of heart failure."|12 months post-transplantation|Transplanted Participants||percentage of participants|||Number
805674|NCT01005329|Secondary|Distant Failure|Will be estimated using the cumulative incidence method.|From registration to date of distant failure or last follow-up. Analysis occurs after all patients have been potentially followed for one year.||||||
805675|NCT01005329|Secondary|Pelvic Failure|Will be estimated using the cumulative incidence method.|From registration to date of pelvic failure or last follow-up. Analysis occurs after all patients have been potentially followed for one year.||||||
805676|NCT01005329|Secondary|Disease-free Survival|Will be estimated using the Kaplan-Meier method.|From registration to date of first failure or last follow-up. Analysis occurs after all patients have been potentially followed for one year.||||||
805677|NCT01005329|Secondary|Overall Survival|Will be estimated using the Kaplan-Meier method.|From registration to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for one year.||||||
805678|NCT01005329|Secondary|Percentage of Participants With Treatment-related Adverse Events as Assessed by NCI CTCAE v4.0||From start of treatment to end of follow-up||||||
805679|NCT01005329|Secondary|Percentage of Participants With Treatment-related, Grade 3+, Non-hematologic Adverse Events as Assessed by NCI CTCAE v4.0||From start of treatment to one year||||||
805697|NCT01005355|Primary|IMC-1121B Pharmacokinetics: Maximum Serum Concentration (Cmax) - Cohorts 1 and 2 During Cycles 1 and 2||Day 1 to Day 15 of Cycles 1 and 2 of a 6-week cycle|All participants in Cohorts 1 and 2 who received study drug and had sufficient pharmacokinetics data to calculate Cmax for Cycles 1 and 2.||micrograms/milliliter (mcg/mL)||Standard Deviation|Mean
806272|NCT01012167|Secondary|Laboratory Measures - Alkaline Phosphatase|Alkaline phosphatase blood level by treatment group and visit.|Once during evaluation and once at the end of 6 weeks of study treatment|Available participant lab data at Evaluation at Week 6.||U/L||Standard Deviation|Mean
805680|NCT01005329|Primary|Percentage of Participants With Treatment-related, Grade 3+, Non-hematologic Adverse Events as Assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0|The rate of the acute specified AEs (adverse events) from previous Radiation Therapy Oncology Group (RTOG) trial 9708 (RT + cisplatin) was 44% and the hypothesis is that the addition of bevacizumab to IMRT + cisplatin will not increase this rate beyond 60%. This study was designed with a 1-sided, upper bound confidence interval to estimate this AE rate. Twenty-seven evaluable patients were required to have 95% confidence that the true grade 3+ non-hematologic treatment-related AE rate is not greater than 60%. Please note that this is a 95% ONE-SIDED confidence bound which is equivalent to the upper bound of a two-sided 90% confidence interval.|From start of treatment to 90 days|||percentage of participants||90% Confidence Interval|Number
805681|NCT01005355|Secondary|Screen for the Development of Circulating Antibodies Against IMC-1121B (Immunogenicity)|Data presented are the number of participants with treatment emergent antibody positive.|Baseline to study completion up to 48 weeks|All participants who received at least 1 dose of study drug.||participants|||Number
805682|NCT01005355|Primary|IMC-1121B Pharmacokinetics: Steady State Volume of Distribution (Vss) - Cohort 3 During Cycles 3 to 5|Due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5, Vss could not be calculated.|Cycles 3, 4 and 5 of a 6-week cycle: predose and 1 hour post-dose|Zero participants were analyzed due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5.|||||
805683|NCT01005355|Primary|IMC-1121B Pharmacokinetics: Steady State Volume of Distribution (Vss) - Cohort 3 During Cycles 1 and 2||Day 1 and Day 22 of Cycles 1 and 2 of a 6-week cycle|All participants in Cohort 3 who received study drug and had sufficient pharmacokinetics data to calculate Vss for Cycle 1. Vss is not calculated for multiple doses, therefore zero participants were analyzed for Cycle 2.||milliliters/kilogram (mL/kg)||Standard Deviation|Mean
805684|NCT01005355|Primary|IMC-1121B Pharmacokinetics: Half-Life (t 1/2) - Cohort 3 During Cycles 3 to 5|Due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5, t1/2 could not be calculated.|Cycles 3, 4 and 5 of a 6-week cycle: predose and 1 hour postdose|Zero participants were analyzed due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5.|||||
805685|NCT01005355|Primary|IMC-1121B Pharmacokinetics: Half-Life (t1/2) - Cohort 3 During Cycles 1 and 2||Day 1 to Day 22 of Cycles 1 and 2 of a 6-week cycle|All participants in Cohort 3 who received study drug and had sufficient pharmacokinetics data to calculate t1/2 for Cycles 1 and 2.||hours||Full Range|Median
805686|NCT01005355|Primary|IMC-1121B Pharmacokinetics - Area Under the Concentration (AUC) - Cohort 3 During Cycles 3 to 5|Due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5, AUC could not be calculated.|Cycles 3, 4 and 5 of a 6-week cycle: predose and 1 hour postdose|Zero participants were analyzed due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5.|||||
805687|NCT01005355|Primary|IMC-1121B Pharmacokinetics: Area Under the Concentration (AUC) - Cohort 3 During Cycles 1 and 2|AUC for Cycle 1 is AUC from time zero to infinity [AUC(0-∞)] and for Cycle 2 is AUC over a dosing interval (AUCτ).|Day 1 to Day 22 of Cycles 1 and 2 of a 6-week cycle|All participants in Cohort 3 who received study drug and had sufficient pharmacokinetics data to calculate AUC(0-∞) for Cycle 1 and AUCτ for Cycle 2.||micrograms*hour/milliliter (mcg*h/mL)||Standard Deviation|Mean
805688|NCT01005355|Primary|IMC-1121B Pharmacokinetics: Maximum Serum Concentration (Cmax) - Cohort 3 During Cycles 3 to 5|Due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5, Cmax could not be calculated.|Cycles 3, 4 and 5 of a 6-week cycle: predose and 1 hour postdose|Zero participants were analyzed due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5.|||||
805689|NCT01005355|Primary|IMC-1121B Pharmacokinetics: Maximum Serum Concentration (Cmax) - Cohort 3 During Cycles 1 and 2||Day 1 to Day 22 of Cycles 1 and 2 of a 6-week cycle|All participants in Cohort 3 who received study drug and had sufficient pharmacokinetics data to calculate Cmax for Cycles 1 and 2.||micrograms/milliliter (mcg/mL)||Standard Deviation|Mean
805690|NCT01005355|Primary|IMC-1121B Pharmacokinetics: Steady State Volume of Distribution (Vss) - Cohorts 1 and 2 During Cycles 3 to 5|Due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5, Vss could not be calculated.|Cycles 3, 4 and 5 of a 6-week cycle: predose and 1 hour postdose|Zero participants were analyzed due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5.|||||
805691|NCT01005355|Primary|IMC-1121B Pharmacokinetics: Steady State Volume of Distribution (Vss) - Cohorts 1 and 2 During Cycles 1 and 2||Day 1 to Day 15 of Cycles 1 and 2 of a 6-week cycle|All participants in Cohorts 1 and 2 who received study drug and had sufficient pharmacokinetics data to calculate Vss for Cycle 1. Vss is not calculated for multiple doses, therefore zero participants were analyzed for Cycle 2.||milliliters/kilogram (mL/kg)||Standard Deviation|Mean
805692|NCT01005355|Primary|IMC-1121B Pharmacokinetics: Half-Life (t 1/2) - Cohorts 1 and 2 During Cycles 3 to 5|Due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5, t1/2 could not be calculated.|Cycles 3, 4 and 5 of a 6-week cycle: predose and 1 hour postdose|Zero participants were analyzed due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5.|||||
805693|NCT01005355|Primary|IMC-1121B Pharmacokinetics: Half-Life (t1/2) - Cohorts 1 and 2 During Cycles 1 and 2||Day 1 to Day 15 of Cycles 1 and 2 of a 6-week cycle|All participants in Cohorts 1 and 2 who received study drug and had sufficient pharmacokinetics data to calculate t1/2 for Cycles 1 and 2.||hours||Full Range|Median
805694|NCT01005355|Primary|IMC-1121B Pharmacokinetics: Area Under the Concentration (AUC) - Cohorts 1 and 2 During Cycles 3 to 5|Due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5, AUC could not be calculated.|Cycles 3, 4 and 5 of a 6-week cycle: predose and 1 hour postdose|Zero participants were analyzed due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5.|||||
805695|NCT01005355|Primary|IMC-1121B Pharmacokinetics: Area Under the Concentration (AUC) Versus Time Curve - Cohorts 1 and 2 During Cycles 1 and 2|AUC for Cycle 1 is AUC from time zero to infinity [AUC(0-∞)] and for Cycle 2 is AUC over a dosing interval (AUCτ).|Day 1 to Day 15 of Cycles 1 and 2 of a 6-week cycle|All participants in Cohorts 1 and 2 who received study drug and had sufficient pharmacokinetics data to calculate AUC(0-∞) for Cycle 1 and AUCτ for Cycle 2.||micrograms*hour/milliliter (mcg*h/mL)||Standard Deviation|Mean
805696|NCT01005355|Primary|IMC-1121B Pharmacokinetics: Maximum Serum Concentration (Cmax) - Cohorts 1 and 2 During Cycles 3 to 5|Due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5, Cmax could not be calculated.|Cycles 3, 4 and 5 of a 6-week cycle: predose and 1 hour postdose|Zero participants were analyzed due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5.|||||
820573|NCT01145898|Primary|3-year Change in OA RI|Measurement of change in ocular blood flow - ophthalmic artery resistance index|Baseline and 36 month visits|||unitless||Standard Error|Mean
805698|NCT01005355|Primary|Number of Participants With Drug-Related Adverse Events|Data presented are the number of participants who experienced adverse events (AE) of any grade, AE of Grade ≥3 based on National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3.0 (NCI-CTCAE v 3.0), serious adverse events (SAE) and AE resulting in death that was considered to be related to IMC-1121B (ramucirumab). A summary of SAEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.|Baseline to study completion up to 48 weeks|All participants who received at least 1 dose of study drug.||participants|||Number
805699|NCT01005459|Primary|Spinal Analgesic Duration|duration of time in minutes from the time the combined spinal epidural is placed until the participant requests additional analgesia; at that time the epidural was dosed and study participation was complete|1-2 hrs|||minutes||Standard Deviation|Mean
805700|NCT01005602|Secondary|Serum Digoxin Concentration by ABCB1 SNP G2677T/A|Serum digoxin concentration by ABCB1 SNP genotypes|Steady-state (2 - 4 weeks after initiation)|||ng/ml||Standard Deviation|Mean
805701|NCT01005602|Secondary|Serum Digoxin Concentration by ABCB1 SNP C3435T|Serum digoxin concentration by genotypes for the ABCB1 SNP C3435T|Steady-state (2 - 4 weeks after initiation)|||ng/ml||Standard Deviation|Mean
805702|NCT01005602|Secondary|Serum Digoxin Concentration by ABCB1 Single Nucleotide Polymorphism (SNP) C1236T|55 patients in the Digoxin Dosing per Nomogram group consented to the Pharmacogenetic substudy and provided blood samples to perform pharmacogenetic analyses. We compared serum digoxin concentrations by ABCB1 genotype.|Steady-state (2 - 4 weeks after initiation)|||ng/ml||Standard Deviation|Mean
805703|NCT01005602|Secondary|Serum Digoxin Concentration < 1.0 ng/ml||Steady-state (2 - 4 weeks after initiation)|||percentage of participants|||Number
805704|NCT01005602|Secondary|Mean Serum Digoxin Concentration||Steady-state (2 - 4 weeks after initiation)|||ng/ml||Standard Deviation|Mean
805705|NCT01005602|Primary|Percent of Patients Achieving a Desired Steady-state Serum Digoxin Concentration Between 0.5 - 0.9ng/ml||Steady-state (2 - 4 weeks after initiation)|||percentage of participants|||Number
805706|NCT01005680|Other Pre-specified|Survival Without Toxicity (SWT)|SWT was defined as the time from randomization to a study-drug related toxicity. Toxicity was defined as Common Terminology Criteria for Adverse Events (CTCAE v3.0) Grade 3 or 4 or death. Participants who do not have a CTCAE Grade 3 or higher toxicity and are alive will be censored at the date of last contact.|Randomization to date of toxicity or date of death up to 34.6 months post-randomization|Safety population: all randomized participants who received at least 1 dose of study drug and were analyzed according to actual treatment received in Cycle 1 of 21-day cycles. Censored participants: PC=22, GC=10.||months||95% Confidence Interval|Median
805707|NCT01005680|Other Pre-specified|Disease Control Rate (DCR)|DCR was the percentage of participants with Complete Response (CR), Partial Response (PR), and Stable Disease (SD). Response determined using Response Evaluation Criteria In Solid Tumors (RECIST v1.0) criteria. CR was defined as the disappearance of all target lesions; PR was defined as at least a 30% decrease in sum of longest diameter of target lesions; progressive disease (PD) was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of 1 or more new lesions; SD was defined as small changes that did not meet the above criteria.|Randomization to date of objective PD or death from any cause up to 35.8 months post-randomization|Tumor Response Qualified Population: all randomized participants who received at least l dose of study drug, who were diagnosed with locally advanced/metastatic non-small cell lung cancer, who had at least 1 baseline and 1 post-baseline tumor measurement, and who are not on concurrent systemic chemotherapy.||percentage of participants|||Number
805708|NCT01005680|Secondary|Risk/Benefit Ratio|Risk/benefit ratio was calculated as the percentage of participants who experienced a study-drug related toxicity of Common Terminology Criteria for Adverse Events (CTCAE v3.0) Cancer Therapy Evaluation Program (CTEP) Grade 3 or higher, divided by the Kaplan-Meier estimated percentage of participants surviving one year.|Randomization to date of death from any cause up to 35.8 months post-randomization|Safety population: all randomized participants who received at least 1 dose of study drug and were analyzed according to actual treatment received in Cycle 1 of 21-day cycle.||ratio|||Number
805709|NCT01005680|Secondary|Tumor Response Rate|Tumor response rate was the percentage of participants with confirmed best tumor response of complete response (CR) or partial response (PR) using Response Evaluation Criteria in Solid Tumor (RECIST v1.0) criteria. Complete Response (CR) was defined as the disappearance of all target lesions; Partial Response (PR) was defined as at least a 30% decrease in sum of longest diameter of target lesions. Progressive disease (PD) assessed using RECIST v1.0 criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of 1 or more new lesions.|Randomization until date of objective PD or death from any cause up to 35.8 months post-randomization|Tumor Response-Qualified Population: all randomized participants who received at least l dose of study drug, who were diagnosed with locally advanced/metastatic non-small cell lung cancer, who had at least 1 baseline and 1 post-baseline tumor measurement, and who were not on concurrent systemic chemotherapy.||percentage of participants|||Number
805710|NCT01005680|Secondary|Time to Treatment Failure (TtTF)|TtTF was defined as date of randomization until the date of discontinuation of study treatment due to adverse event, progressive disease (PD), or death from any cause. PD assessed using Response Evaluation Criteria in Solid Tumor (RECIST v1.0) criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of 1 or more new lesions. Participants who discontinued study treatment for any other reason were censored at the date of discontinuation of study treatment. Participants still on study drug at data-inclusion cut-off date were censored at the cut-off date.|Randomization until date of discontinuation of study treatment due to adverse events, PD, or death from any cause up to 6.3 months post-randomization|Intent-to-Treat: all randomized participants who were analyzed according to the treatment group they were randomly assigned. Censored participants: PC=85, GC=91.||months||95% Confidence Interval|Median
805725|NCT01005719|Secondary|Number of Participants With Intragastric pH >4 for More Than 50% of the Time on Day 7|"Number of participants maintaining intragastric pH > 4 for at least 12 hrs at
steady-state on Day 7"|Treatment dose to 24-hour post-dose on Day 7|Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.||Participants|||Number
805711|NCT01005680|Secondary|Duration of Response (DoR)|DoR was defined as the time from first objective status assessment of complete response (CR) or partial response (PR) to the first time progressive disease (PD) or death as a result of any cause. Response using Response Evaluation Criteria in Solid Tumor (RECIST v1.0) criteria. CR was defined as the disappearance of all target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions. Participants who are not known to have died or to have PD were censored at the date of last contact. PD assessed using RECIST v1.0 and defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of 1 or more new lesions|Date of first response to the date of (PD) or death from any cause up to 22.9 months post-randomization|Intent-to-Treat: all randomized participants who were analyzed according to the treatment group they were randomly assigned and who achieved CR or PR. Censored participants: PC=1, GC=0.||months||95% Confidence Interval|Median
805712|NCT01005680|Secondary|Time to Progressive Disease (TtPD)|TtPD defined as the time from study randomization to the first date of progressive disease (PD). PD assessed using Response Evaluation Criteria in Solid Tumor (RECIST v1.0) criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of 1 or more new lesions. Participants who were not known to have PD or who died without PD were censored at the date of last of last tumor assessment.|Randomization to first date of PD up to 23.7 months post-randomization|Intent-to-Treat: all randomized participants who were analyzed according to the treatment group they were randomly assigned. Censored participants: PC=12, GC=19.||months||95% Confidence Interval|Median
805713|NCT01005680|Secondary|Progression Free Survival (PFS)|PFS was defined as the date of randomization to date of first observation of clinical or objective progressive disease (PD) or death due to any cause. PD assessed using Response Evaluation Criteria in Solid Tumor (RECIST v1.0) criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of one or more new lesions. Participants who were not known to have died or had PD were censored at the date of last contact.|Randomization to first date of Progressive Disease (PD) or death from any cause up to 33.0 months post-randomization|Intent-to-Treat: all randomized participants who are analyzed according to the treatment group they were randomly assigned. Censored participants: PC=8, GC=10.||months||95% Confidence Interval|Median
805714|NCT01005680|Primary|Overall Survival (OS)|OS was defined as the duration from date of randomization to date of death from any cause. Participants who were alive were censored at the date of last contact.|Randomization to date of death from any cause up to 35.8 months post-randomization|Intent-to-Treat: all participants and are analyzed according to the treatment group they were randomly assigned. Censored participants: PC=37, GC=39.||months||95% Confidence Interval|Median
805715|NCT01005706|Primary|Effectiveness and Safety of a Particular Drug Regimen to Prevent Kidney Rejection|Number of Participants with Kidney Rejections|12 months|||participants|||Number
805716|NCT01005719|Secondary|Time to Achieve Sustained Advantage Over No Treatment During the First 4 Hours After Dosing|"The earliest time during the first 4 hours after dosing that the median
pH for the treatment is over 1 unit higher than that for the No treatment during the next three 5 minute intervals. (When this condition does not occur, the time to sustained advantage will be imputed as 4 hours.)"|Treatment dose to event on Day 1 and Day 7|Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.||Minutes||Full Range|Median
805717|NCT01005719|Secondary|Percentage of Time Intragastric pH >4 During the First 4 Hours on Day 1||Treatment dose to 4-hours post-dose on Day 1|Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.||Percentage of Time||Full Range|Median
805718|NCT01005719|Secondary|Percentage of Time Intragastric pH >4 Over the Nocturnal Period on Day 1||Treatment dose to 24-hour post-dose on Day 1|Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.||Percentage of Time||Full Range|Median
805719|NCT01005719|Secondary|Number of Participants Maintaining Intragastric pH > 3.5 for at Least 12 Hours on Day 1||Treatment dose to 24-hr post-dose on Day 1|Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.||Participants|||Number
805720|NCT01005719|Secondary|Number of Participants Maintaining Intragastric pH > 4 for at Least 12 Hours on Day 1||Treatment dose to 24-hr post-dose on Day 1|Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.||Participants|||Number
805721|NCT01005719|Secondary|Time to Onset of Inhibition of Acid Secretion on Day 1|The onset of inhibition of acid secretion was the first time to sustain median pH >3.5 for each of the twenty-four successive 5-minute periods. If this condition was not met for any time point within the first 4 hours following dosing, a score of 240 minutes was imputed.|Treatment dose to onset of event on Day 1|Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.||Minutes||Full Range|Median
805722|NCT01005719|Secondary|Time to Achieve Sustained Intragastric pH > 3.5 at Steady-state on Day 7|The first time to sustain median pH > 3.5 for at least 3 successive 5-minute periods within the first 2 hours after dosing with Zegerid Capsules, and Prevacid Capsules, or No treatment on the 7th day of respective treatments. If this condition was not met for any time point within the first 2 hours following dosing, a score of 120 minutes was imputed.|Treatment dose to 2-hours post-dose on Day 7|Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.||Minutes||Full Range|Median
805723|NCT01005719|Secondary|Percentage of Time Intragastric pH >4 Over the Nocturnal Period on Day 7||Treatment dose to 24-hour post-dose on Day 7|Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.||Percentage of Time||Full Range|Median
805724|NCT01005719|Secondary|Number of Participants With Intragastric pH >3.5 for More Than 50% of the Time on Day 7|"Number of participants maintaining intragastric pH > 3.5 for at least 12 hrs at
steady-state on Day 7"|Treatment dose to 24-hour post-dose on Day 7|Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.||Participants|||Number
816298|NCT01107418|Primary|Maximum Plasma Concentration (Cmax) of Vemurafenib on Day 1||Pre-dose, 1, 2, 4, 5, 8 hours post-dose on Day 1|PK population.||micrograms/milliliter (mcg/mL)||Standard Deviation|Mean
805730|NCT01005719|Secondary|Median Time to Achieve Intragastric pH > = 3.5 for a 10-Minute Period|The time required to achieve an intragastric pH ≥3.5 that is reached for 10 consecutive minutes after drug administration on the 1st and 7th days of dosing.|Treatment dose to 4-hr post-dose on Day 1 and Day 7|Participants who received at least one dose of study treatment, and did not have missing values.||Minutes||Full Range|Median
805731|NCT01005719|Secondary|The Difference in the Onset of Action Based on Median pH Values Between the Two Active Treatments Compared to No Treatment on Day 1 and Day 7|Median intragastric pH scores were collected at 5 minute intervals after treatment dose. The difference in the onset of action was the earliest 5 minute interval (from start of interval to end of interval) for which each active treatment presented a statistically significantly advantage over No treatment based on median pH values. The earliest 5 minute interval showing the difference in onset of action is reported here.|Treatment dose to 4-hr post-dose on Day 1 and Day 7|Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.||pH||Full Range|Median
805732|NCT01005719|Secondary|Achievement of Sustained Difference in Inhibition of Intragastric Acidity Based on Median pH Values Between the Two Active Study Treatments at Steady-state on Day 1|Median intragastric pH scores were collected at 5 minute intervals after treatment dose. The achievement of sustained difference was the earliest time for which a statistically significant difference was observed in the median intragastric pH scores for 3 consecutive 5-minute intervals. The earliest 3 time points for which a statistically significant difference was observed between the median intragastric pH values for the two active treatments for three consecutive 5-minute intervals are shown here.|Treatment dose to 4-hr post-dose on Day 1|Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.||pH||Full Range|Median
805733|NCT01005719|Primary|Achievement of Sustained Difference in Inhibition of Intragastric Acidity Based on Median pH Values Between the Two Active Study Treatments at Steady-state on Day 7|Median intragastric pH scores were collected at 5 minute intervals after treatment dose. The achievement of sustained difference was the earliest time for which a statistically significant difference was observed in the median intragastric pH scores for 3 consecutive 5-minute intervals. The earliest 3 time points for which a statistically significant difference was observed between the median intragastric pH values for the two active treatments for three consecutive 5-minute intervals are shown here.|Treatment dose to 4-hr post-dose on Day 7|Participants who received at least one dose of study treatment, and did not have missing values.||pH||Full Range|Median
805734|NCT01005732|Secondary|Compliance With Wearing Compression Garment|The patients were asked to complete a compliance form indicating how many hours the garment was worn each day.|About 12 months (follow-up visit 5)|All Participants with available and evaluable data.||hours per day||Standard Deviation|Mean
805735|NCT01005732|Secondary|Clinical Appearance of Wound|"Photographs of wounds showed final cosmetic result. The two compression areas for each photograph were labeled distal (D) and proximal (P). We asked 11 experts (blinded as to the compression of the rated zones) to judge which zone (D or P) had the better cosmetic appearance or whether there was no difference. Votes were tallied according to the unblinded compression zone (i.e., high/normal and low). We report number of participants for which the rating experts all agreed or did not all agree (i.e., voted the other zone or no difference) that the indicated zone had the better appearance."|Approximately 12 months (follow-up visit 5)|All Participants with available and evaluable measurement.||Participants|||Number
805736|NCT01005732|Secondary|Thickness of Wound|Scar thickness in millimeters was obtained with high-frequency ultrasonography in the Department of Radiology. Several machines and probes were used over the years each with accuracy to 0.5 mm. The area of interest was triangulated and measurements obtained at the corners were averaged; the sides of the triangle were 3–5 cm.|Approximately 12 months (follow-up visit 5)|All Participants with available and evaluable measurement.||mm||Standard Deviation|Mean
805737|NCT01005732|Secondary|Color of Wound|A Chromameter Minolta CR-300 (Konica Minolta, Ramsey, NJ) measured skin color. Skin surface illuminated by pulsed xenon arc lamp. Light reflected perpendicular to surface collected for a tri-stimulus color analysis. One measurement consisted of three flashes of illumination in order to obtain a mean value. Measurement values are in the L*a*b* color space was described by The Commission Internationale de I’Eclairage (CIE)(L=brightness [100=white,0=black], a=red-green[red=60,green=-60], b=yellow-blue[yellow=60,blue=-60])|Approximately12 months (follow-up visits 5)|All Participants with available and evaluable measurement.||color space parameter units|Participants|Standard Deviation|Mean
805738|NCT01005732|Secondary|Durometer (Hardness) of Wound|"A single Rex Durometer Hand Model 1600, Type 00, without a foot attachment (Rex Gauge Company Inc., Glenview, IL) was used to measure scar hardness throughout the study. This device measures hardness of light foams, sponge rubber gels, and animal tissue in durometer units (range 0=soft, 100=hard). Measurements were obtained with the person in the sitting position with the forearm supported in a horizontal position on a desk and the shoulder adducted. The area of interest was triangulated and measurements obtained at the corners were averaged; the sides of the triangle were 3–5 cm."|Approximately 2.5, 5, 7.5, 10, and 12 months (follow-up visits 1-5)|All Participants with available and evaluable measurement.||durometer units||Standard Deviation|Mean
805739|NCT01005732|Primary|Pressure Under Compression Garment|Pressure measurements were obtained at the scar/garment interface using the I-ScanTM System (Tekscan, Inc., South Boston, MA). The device was calibrated and the pressure determined in mmHg. Pressure measurements were obtained by a therapist not involved in the care of the patient, who was trained in the use of the device. Therefore pressure ‘‘dose’’ was measured directly. Values reported are averaged over indicated visits.|Approximately 2.5, 5, 7.5, 10, and 12 months (follow-up visits 1-5)|All Participants with available and evaluable measurement.||mm Hg||Standard Deviation|Mean
805740|NCT01005745|Secondary|Number of Participants With Objective Response (OR)|OR is defined as the patient being alive at Day 70 and tumor size evaluated using the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria to be a complete response or partial response. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Evaluations were made by computed tomography (CT) scan approximately 6 to 8 weeks after the cell infusion, or CT scan approximately 10 weeks after the cell infusion, or by clinical evaluation during the first 70 days.|Average of 10 Months Follow-up|All participants who completed treatment||participants|||Number
805741|NCT01005745|Primary|Number of Participants With Tumor Infiltrating Lymphocytes (TIL) Growth|Feasibility was the primary endpoint of this trial, defined as a patient who can grow and expand T-cells: Number of participants with fragments cultured; Number of participants with fragments that reached a final count of 20e6 cells within 5 weeks of culture; Number of participants with fragments that reached a final count of 20e6 cells within 5 weeks of culture and were cocultured with autologous or human leukocyte antigen (HLA)-matched tumor cells for interferon(IFN)-γ production; Number of participants with fragments that produced IFN-γ in response to autologous or HLA-matched tumor cells.|192 Days Post Surgical Resection|All participants||participants|||Number
805742|NCT01005875|Secondary|The Degree of Change in Necrosis and Vascular Permeability Via Dynamic Contrast Enhanced (DCE) and Diffusion-weighted Imaging (DWI) Magnetic Resonance Imaging (MRI) as Measured by ADC (Apparent Diffusion Coefficient).|the measured ADC at baseline, 4 weeks after baseline and then 10 weeks after baseline. ADC quantifies the motion of water protons from an MRI.|baseline, 4 weeks post baseline, 10 weeks post baseline|||milimeters^2/sec||Standard Deviation|Mean
805743|NCT01005875|Secondary|The Degree of Change in Necrosis and Vascular Permeability Via Dynamic Contrast Enhanced (DCE) and Diffusion-weighted Imaging (DWI) Magnetic Resonance Imaging (MRI) as Measured by Kep. Kep Describes How Fast Contrast Can Redistribute in Tissue.|The Kep as measures by MRI at baseline, 4 weeks after baseline, and 10 weeks after baseline.|baseline, 4 weeks after baseline and 10 weeks post baseline|||Min^ -1||Standard Deviation|Mean
805744|NCT01005875|Secondary|The Degree of Change in Necrosis and Vascular Permeability Via Dynamic Contrast Enhanced (DCE) and Diffusion-weighted Imaging (DWI) Magnetic Resonance Imaging (MRI) as Measured by Ktrans (Volume Transfer Coefficient).|The initial mean Ktrans at baseline, 4 weeks and 10 week. K trans is used to describe the uptake of gadolinium contrast in tissue.|baseline, 4 weeks and 10 weeks|||min^ -1||Standard Deviation|Mean
805745|NCT01005875|Secondary|The Degree of Change in Necrosis and Vascular Permeability Via Dynamic Contrast Enhanced (DCE) and Diffusion-weighted Imaging (DWI) Magnetic Resonance Imaging (MRI) as Measured by Tumor Volume|mean tumor volume at baseline, 4 weeks and 10 weeks after start of treatment|baseline, 4 weeks and 10 weeks|||centimeters^3||Standard Deviation|Mean
805746|NCT01005875|Primary|Determine the Safety and Tolerability of Sequential SBRT and Sorafenib in Patients With Unresectable Hepatocellular Carcinoma|Number of subjects experiencing a Grade 5 toxicity related to SBRT and sorafenib|between baseline and 3 years|||participants|||Number
805747|NCT01005888|Secondary|Functional C1INH Serum Levels|"Percent change in functional C1INH serum levels from pre-infusion to 1 hour post-infusion at Visit 1 and Weeks 4, 8, and 12. Pre-infusion samples obtained at Visit 1 of each therapy period (i.e., baseline) were used to determine change at 1 hour post-infusion for all visits.
Functional C1INH serum levels are expressed as a percent of total detectable C1INH (i.e., functional C1INH/total detectable C1INH)."|Pre-infusion to 1 hour post-infusion at Visit 1 and Weeks 4, 8, and 12|Efficacy Dataset subjects with data at both sampling time points (N=20 C1INH-nf, N=22 placebo).||percent of functional C1INH||Standard Deviation|Mean
805748|NCT01005888|Secondary|Antigenic C1 Inhibitor (C1INH) Serum Levels|Change in antigenic C1INH serum levels from pre-infusion to 1 hour post-infusion at Visit 1 and Weeks 4, 8, and 12. Pre-infusion samples obtained at Visit 1 of each therapy period (i.e., baseline) were used to determine change at 1 hour post-infusion for all visits.|Pre-infusion to 1 hour post-infusion at Visit 1 and Weeks 4, 8, and 12|Efficacy Dataset subjects with data at both sampling time points (N=19 C1INH-nf, N=22 placebo).||mg/dL||Standard Deviation|Mean
805749|NCT01005888|Other Pre-specified|Total Number of Days of Swelling During Each Prophylactic Therapy Period|A day of swelling was defined as a day that a subject reported swelling at any of the five locations (abdominal, genitourinary, facial, respiratory [including laryngeal], or extremity).|12 weeks|Efficacy Dataset.||days||Standard Deviation|Mean
805750|NCT01005888|Secondary|Number of Open-label C1INH-nf Infusions Required During Each Prophylactic Therapy Period|The study design allowed for subjects to be treated with open-label C1INH-nf for laryngeal angioedema, if deemed necessary by the investigator, or prior to emergency surgical procedures.|12 weeks|Efficacy Dataset.||infusions||Standard Deviation|Mean
805751|NCT01005888|Secondary|Average Duration of HAE Attacks During Each Prophylactic Therapy Period|"The duration of an attack was measured from the first report of swelling at any one of the five locations (abdominal, genitourinary, facial, respiratory [including laryngeal], or extremity) until the first subsequent report of no swelling at all five locations."|12 weeks|Efficacy Dataset.||days||Standard Deviation|Mean
805752|NCT01005888|Secondary|Average Severity of HAE Attacks During Each Prophylactic Therapy Period|All attacks in each therapy period were assigned a value of 1 (mild), 2 (moderate), or 3 (severe). Attack severity was considered the highest value assigned by the subject to any swelling location during the attack. Average severity was set to 0 if there was no attack in a period.|12 weeks|Efficacy Dataset.||units on a scale||Standard Deviation|Mean
805753|NCT01005888|Secondary|Number of Subject Withdrawals During Each Prophylactic Therapy Period|At the end of each therapy period, each subject was assigned a yes/no drop-out status. A drop-out was defined as a subject who did not have a Week 12 visit record.|12 weeks|The Safety Dataset (N=24) consisted of all randomized subjects who received at least 1 complete or partial infusion of study drug. 24 subjects began Period 1 (12 C1INH-nf, 12 placebo) and received study drug. 22 subjects crossed over to Period 2 (11 placebo, 11 C1INH-nf) and received study drug. Thus, 23 randomized subjects received each therapy.||participants|||Number
805754|NCT01005888|Primary|Number of Hereditary Angioedema (HAE) Attacks During Each Prophylactic Therapy Period|An HAE attack was defined as the subject-reported indication of swelling at any location following a report of no swelling on the previous day. Analyses include observed attack counts and normalized attack counts (i.e., the number of attacks observed during each therapy period, normalized for the number of days the subject participated in that period).|12 weeks|The Efficacy Dataset (N=22) consisted of all randomized subjects who completed 12 weeks of therapy in Period 1 and received at least one infusion of study drug in Period 2.||attacks||Standard Deviation|Mean
805778|NCT01005914|Primary|Complete Response Rate After Course 1 of Pegaspargase When Administered in Combination With Hyper-CVAD Regimen|The complete response rate after 1A cycle of a PEG-Asparaginase and hyper-CVAD combination regimen will be estimated, and an exact 95% confidence interval will be computed using a binomial distribution.|After day 4 of treatment|Outcome Measure analysis was not performed due to early termination of the study due to safety concerns|||||
805755|NCT01005901|Secondary|Mean Daily Total Symptom Score Over the 26 Week Treatment Period|"The daily symptom score was calculated as the sum of the worst of the morning and evening assessments for each symptom (symptoms, cough, wheeze, sputum color/production, and breathlessness). The score can range from 0 to 18 with 0 indicating no symptoms. The higher the score, the worse the symptomatic status. A negative change (lower number) indicates improvement.
Mixed model used baseline symptom variables, baseline inhaled corticosteroid (ICS) use, FEV1 prior to inhalation of short acting beta-agonist (SABA), and FEV1 45 minutes post-inhalation of SABA as covariates."|26 Weeks|Full Analysis Set (FAS) included all randomized patients who received at least one dose of study medication.||units on a scale||Standard Error|Least Squares Mean
805756|NCT01005901|Secondary|Percentage of Days Able to Perform Usual Daily Activities Over the 26 Week Treatment Period|"The percentage of days able to perform usual daily activities is defined as the total number of days able to perform usual activities over the 26 week treatment period divided by the total number of days where diary recordings have been made.
Mixed model used baseline ability to perform usual daily activities, baseline ICS use, FEV1 prior to inhalation of SABA, and FEV1 45 minutes post-inhalation of SABA as covariates."|26 Weeks|Full Analysis Set (FAS) included all randomized patients who received at least one dose of study medication. At 26 weeks, the analysis is based on only patients with a value at both baseline and post-baseline.||percentage of days||Standard Error|Least Squares Mean
805757|NCT01005901|Secondary|Percentage of Days With no Daytime Symptoms Over the 26 Week Treatment Period|"The percentage of days with no daytime symptoms is defined as the total number of days with no daytime symptoms over the 26 week treatment period divided by the total number of days where diary recordings have been made.
Mixed model used baseline daytime symptoms, baseline ICS use, FEV1 prior to inhalation of SABA, and FEV1 45 minutes post-inhalation of SABA as covariates."|26 Weeks|Full Analysis Set (FAS) included all randomized patients who received at least one dose of study medication. At 26 weeks, the analysis is based on only patients with a value at both baseline and post-baseline.||percentage of days with no symptoms||Standard Error|Least Squares Mean
805758|NCT01005901|Secondary|Percentage of Nights With no Nighttime Awakenings Over the 26 Week Treatment Period|"The percentage of nights with no nighttime awakenings is defined as the total number of nights with no nighttime awakenings over the 26 week treatment period divided by the total number of night where diary recordings have been made.
Mixed model used baseline nighttime awakenings, baseline ICS use, FEV1 prior to inhalation of SABA, and FEV1 45 minutes post-inhalation of SABA as covariates."|26 Weeks|Full Analysis Set (FAS) included all randomized patients who received at least one dose of study medication. At 26 weeks, the analysis is based on only patients with a value at both baseline and post-baseline.||percentage of nights with no awakenings||Standard Error|Least Squares Mean
805759|NCT01005901|Secondary|Rate of Moderate or Severe COPD Exacerbations Over the 26 Week Treatment Period|One overall rate is calculated for the entire study population. Rate is the number of moderate or severe exacerbations per year = total number of moderate or severe exacerbations for all participants/total number of treatment years for all participants. COPD exacerbations were considered to be moderate if treatment with systemic corticosteroids and/or antibiotics was required. COPD exacerbations were considered to be severe if treatment for moderate severity and hospitalization were required.|26 weeks|Full Analysis Set (FAS) included all randomized patients who received at least one dose of study medication.||exacerbations per year|||Number
805760|NCT01005901|Secondary|Number of Participants With Adverse Events, Death, and Serious or Clinically Significant Adverse Events or Related Discontinuations|Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.|26 Weeks and 30 Day follow-up|The safety set included all patients who received at least one dose of study medication whether or not being randomized. Patients were randomized according to the treatment they received.||participants|||Number
805761|NCT01005901|Secondary|Change in 24-hourly Mean Heart Rate at Day 1, Week 12 and Week 26|The mean heart rate was collected with a 24 hour Holter monitor in a sub-set of the safety population. The change between baseline and day 1, week 12 and week 26 was calculated. The analysis of the Holter recordings was performed by a central facility. Data on heart rate, heart rate variability, supraventricular and ventricular ectopy were collected and assessed.|Baseline, Day 1, Week 12 and Week 26|"The safety set included all patients who received at least one dose of study medication whether or not being randomized. A sub-set of the safety population had 24 hour Holter monitoring. n indicates patients with observations both at baseline and each endpoint."||beats per minute||Standard Deviation|Mean
805762|NCT01005901|Secondary|Trough FEV1 and FVC at Day 1 and Week 26|"Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 hour 15 minute and 23 hour 45 minute post-dose FEV1 readings. Mixed model used baseline FEV1, baseline ICS use, FEV1 prior to inhalation of SABA, and FEV1 45 minutes post-inhalation of SABA as covariates.
Trough FVC was defined as the average of the 23 hour 15 minute and 23 hour 45 minute post-dose FVC readings. Mixed model used baseline FVC, baseline ICS use, FEV1 prior to inhalation of SABA, and FEV1 45 minutes post-inhalation of SABA as covariates."|Day 1 and Week 26|Full Analysis Set (FAS) included all randomized patients who received at least one dose of study medication. If one of the 23 h 15 min or 23 h 45 min values are missing then the remaining non-missing value is taken as trough FEV1 or trough FVC. If both values are missing, then their trough FEV1 or trough FVC is regarded as missing||Liters||Standard Error|Least Squares Mean
805763|NCT01005901|Secondary|FEV1 Area Under Curve (AUC) (5 Min - 23 Hour 45 Min) at Week 12 and Week 26|The standardized (with respect to the length of time) area under the curve (AUC) for FEV1 was calculated using trapezoidal rule between 5 min and 23 h 45 min post dose at week12/week 13and week 26/week 27 where available for every patient in the serial spirometry subgroup. Mixed model used baseline FEV1,baseline inhaled corticosteroid (ICS) use, FEV1 prior to inhalation of short acting beta-agonist (SABA), and FEV1 45 minutes post-inhalation of SABA as covariates.|Week 12 and Week 26|Serial spirometry group, a sub-set of the full analysis set of patients. Twelve hour serial spirometry was conducted in this subset of patients in selected centers at Day 1. At week 12/13 and week 26/27 a 24 hour serial spirometry was performed.||Liters||Standard Error|Least Squares Mean
805764|NCT01005901|Secondary|FEV1 Area Under the Curve (AUC) (5 Min - 12 Hour) at Day 1, Week 12 and Week 26|The standardized (with respect to the length of time) area under the curve (AUC) for FEV1 was calculated using trapezoidal rule between 5 min and 12 h post dose at Week 1 Day 1, Week 12 and Week 26 for every patient in the serial spirometry subgroup. Mixed model used baseline FEV1,baseline inhaled corticosteroid (ICS) use, FEV1 prior to inhalation of short acting beta-agonist (SABA), and FEV1 45 minutes post-inhalation of SABA as covariates.|Day 1, Week 12 and Week 26|"Serial spirometry group, a sub-set of the full analysis set of patients. Twelve hour serial spirometry was conducted in this subset of patients in selected centers at Day 1. At week 12/13 and week 26/27 a 24 hour serial spirometry was performed. n is the number of patients with non-missing observations at each time point."||Liters||Standard Error|Least Squares Mean
805765|NCT01005901|Secondary|Forced Vital Capacity (FVC) at Each Time-point on Day 1 and Week 26|Spirometry was conducted according to internationally accepted standards. FVC was calculated at each time point up to 4 hours post-dose and at 23 hours 15 min and 23 hours 45 min, by visit. Mixed model used baseline FVC, baseline inhaled corticosteroid (ICS) use, FEV1 prior to inhalation of short acting beta-agonist (SABA), and FEV1 45 minutes post-inhalation of SABA as covariates.|Day 1 and Week 26|Full Analysis Set (FAS) included all randomized patients who received at least one dose of study medication. “n” indicates number of patients with observation at each time-point.||Liters||Standard Error|Least Squares Mean
805766|NCT01005901|Secondary|FEV1 at Each Time-point on Day 1 and Week 26|Spirometry was conducted according to internationally accepted standards. FEV1 was measured at all time points up to 4 hours post-dose, and at 23 hours 15 min and 23 hours 45 min, by visit. Mixed model used baseline FEV1,baseline inhaled corticosteroid (ICS) use, FEV1 prior to inhalation of short acting beta-agonist (SABA), and FEV1 45 minutes post-inhalation of SABA as covariates.|Day 1 and Week 26|Full Analysis Set (FAS) included all randomized patients who received at least one dose of study medication. “n” indicates number of patients with observation at each time-point||Liters||Standard Error|Least Squares Mean
805767|NCT01005901|Secondary|Change From Baseline in the Mean Number of Puffs Per Day of Rescue Medication Over the Study Duration (Baseline to Week 26)|Participants recorded the number of puffs of rescue medication taken in the previous 12 hours in the morning and evening. The total number of puffs of rescue medication per day over the full 26 weeks was calculated and divided by the total number of days with non-missing rescue medication data to derive the mean daily number of puffs of rescue medication taken for the patient.|26 weeks|Full Analysis Set (FAS) included all randomized patients who received at least one dose of study medication. Patients with observations both at baseline and week 26 were included in this analysis||Puffs per day||Standard Error|Least Squares Mean
805768|NCT01005901|Secondary|Time to First Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation During 26 Weeks of Treatment|The time to the first moderate or severe COPD exacerbation was the study day on which the patient experienced first moderate or severe COPD exacerbation. COPD exacerbations are considered to be moderate if treatment with systemic corticosteroids and/or antibiotics was required. COPD exacerbations are considered to be severe if treatment for moderate severity and hospitalization were required.|26 weeks|"Full Analysis Set (FAS) included all randomized patients who received at least one dose of study medication.
The median values were not estimable."||Days||95% Confidence Interval|Median
805769|NCT01005901|Secondary|Quality of Life Assessment With St. George's Respiratory Questionnaire (SGRQ) Total Score After 26 Weeks of Treatment|SGRQ is a health related quality of life questionnaire consisting of 51 items in three components: symptoms, activity, and impacts. The lowest possible value is zero and the highest 100. Higher values correspond to greater impairment in quality of life. Mixed model used baseline SGRQ, baseline inhaled corticosteroid (ICS) use, FEV1 prior to inhalation of short acting beta-agonist (SABA), and FEV1 45 minutes post-inhalation of SABA as covariates.|26 weeks|Full Analysis Set (FAS) included all randomized patients who received at least one dose of study medication. Individual component score was imputed with LOCF (last observation carried forward).||Units on a scale||Standard Error|Least Squares Mean
805770|NCT01005901|Secondary|Transition Dyspnea Index (TDI) Focal Score After 26 Weeks of Treatment|Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement from baseline. Mixed model used baseline TDI, baseline inhaled corticosteroid (ICS) use, FEV1 prior to inhalation of short acting beta-agonist (SABA), and FEV1 45 minutes post-inhalation of SABA as covariates.|26 weeks|Full Analysis Set (FAS) included all randomized patients who received at least one dose of study medication. Patients per treatment group with no missing data were included in this analysis.||Units on a scale||Standard Error|Least Squares Mean
805771|NCT01005901|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) at 12 Weeks|Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 hour 15 minute and 23 hour 45 minute post-dose FEV1 readings. Mixed model used baseline FEV1,baseline inhaled corticosteroid (ICS) use, FEV1 prior to inhalation of short acting beta-agonist (SABA), and FEV1 45 minutes post-inhalation of SABA as covariates.|12 weeks|Full Analysis Set (FAS) The FAS included all randomized patients who received at least one dose of study medication. Patients in this group were analyzed according to the treatment to which they were randomized. Missing trough FEV1 values at week 12 were imputed using LOCF with pre-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
805772|NCT01005914|Secondary|Half-life of Pegaspargase||The approximate t½ in adult patients is 5.73 days. The half-life is independent of the dose administered, disease status, renal or hepatic function, age, or gender.||||||
805773|NCT01005914|Secondary|Rate of Minimal Residual Disease|Cycle 1A: Days 1 through 14 Cycle 1B: Days 1 through 8, after the first 14 days of cycle 1A|End of cycles 1A and 1B||||||
805774|NCT01005914|Secondary|Overall Survival||At least every 6 months until death.||||||
805775|NCT01005914|Secondary|Proportion of Patients Who Achieve Complete Response or Partial Response After Courses 1 and 2||An interim analysis of safety is planned after the enrollment of 15 evaluable patients.||||||
805776|NCT01005914|Secondary|2-year Progression-free Survival||After completion of 8 cycles||||||
805777|NCT01005914|Primary|Grade 3 and 4 Toxicity Associated With the Combination of Peg-Asparaginase and Hyper-CVAD Which Include: Allergic Reactions, Elevated Liver Enzymes, Hyperbilirubinemia, Hyperglycemia, Central Nervous System (CNS) Thrombosis, and Pancreatitis.||The assessment of safety will be based mainly on the frequency of adverse events||||||
805782|NCT01006018|Primary|Insulin Secretion|Not measured as study was prematurely terminated due to unanticipated delays.|baseline, 6 months, 9 months (after a 3 month washout)||||||
805783|NCT01006122|Secondary|Computer Based Objective Cognition Testing (CogState ) Composite Score|CogState had 5 outcome measures that measured the cognitive constructs. GMLT, detection, identification, one card learning and CPAL. GMLT score range: 0 (best) to infinity (worst), detection and identification score range: 2 (best) to 3.3 (worst); One card learning score range: 0 (worse) to 1.57 (best) and CPAL score range: 0 (best) to infinity (worst). The individual score was standardized at each assessment and was then averaged to yield a composite score; total possible score: minus infinity to plus infinity. Positive composite score=improved performance.|Baseline, Day 5, 10, 15, 20 of titration phase; Day 21 of stable dosing phase|FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here “N” (number of participants analyzed) signifies participants who were evaluable for this outcome measure and “n” signifies participants who were evaluable at specified time points for each arm, respectively.||Units on a scale||Standard Deviation|Mean
805784|NCT01006122|Secondary|Computer Based Objective Cognition Testing (CogState) Continuous Paired Associate Learning (CPAL)|CPAL: a cognitive test which assessed visual episodic learning. Participant was to learn and remember picture locations on the screen and was to tap the target on the central location to begin. As each picture was revealed, the participant was to remember where the picture was located and tap that location. The outcome measure was the number of errors made in correctly placing each of the 4 patterns in their location 4 times. Score ranges from 0 to infinity. Lower scores meant a better performance.|Baseline, Day 5, 10, 15, 20 of titration phase; Day 21 of stable dosing phase|FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here “N” (number of participants analyzed) signifies participants who were evaluable for this outcome measure and “n” signifies participants who were evaluable at specified time points for each arm, respectively.||errors||Standard Deviation|Mean
805785|NCT01006122|Secondary|Computer Based Objective Cognition Testing (CogState) One Card Learning|One card learning: a cognitive test which assessed visual learning. Participants were to remember which cards were previously shown in a task. The outcome measure was accuracy of performance; arcsine transformation of the square root of the proportion of correct responses. Score ranges from 0 (worse) to 1.57 (best). Higher scores meant a better performance.|Baseline, Day 5, 10, 15, 20 of titration phase; Day 21 of stable dosing phase|FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here “N” (number of participants analyzed) signifies participants who were evaluable for this outcome measure and “n” signifies participants who were evaluable at specified time points for each arm, respectively.||arcsine (square root proportion correct)||Standard Deviation|Mean
805786|NCT01006122|Secondary|Computer Based Objective Cognition Testing (CogState) Identification Speed|Identification speed: a cognitive test which assessed visual attention. A playing card was presented face up in the center of the screen. As soon as this happened, the participant had to decide whether the card was red or not. The outcome measure was speed of performance; mean of the log10 transformed reaction time for correct responses (measured in log10 msec). Score ranges from 2 (best) to 3.3 (worst). Lower scores meant a better performance.|Baseline, Day 5, 10, 15, 20 of titration phase; Day 21 of stable dosing phase|FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here “n” signifies participants who were evaluable at specified time points for each arm, respectively.||log10 msec||Standard Deviation|Mean
805806|NCT00999661|Primary|Percent Excess Weight Change From Baseline to 24 Months|Percent excess weight change from baseline to 24 months was calculated as (the baseline weight minus the weight at 24 months) divided by the (baseline weight minus the ideal body weight (using the upper limit of the midpoint range in the Metropolitan Tables for Life Insurance, 1983) x 100). Last observation carried forward was used for early terminated subjects.|Baseline to 24 months|Intent to Treat Population - All subjects implanted with gastric band and signing informed consent.||percent of excess weight at baseline||Standard Deviation|Mean
805787|NCT01006122|Secondary|Computer Based Objective Cognition Testing (CogState) Detection Speed|Detection speed: a cognitive test which assessed psychomotor function. A playing card was presented face up in the center of the screen. As soon as this happened, the participant was to press the 'Yes' key. The outcome measure was speed of performance; mean of the log10 transformed reaction time for correct responses [measured in log10 milliseconds (msec)]. Scores ranges from 2 (best) to 3.3 (worst). Lower scores meant a better performance.|Baseline, Day 5, 10, 15, 20 of titration phase; Day 21 of stable dosing phase|FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here “n” signifies participants who were evaluable at specified time points for each arm, respectively.||log10 msec||Standard Deviation|Mean
805788|NCT01006122|Secondary|Computer Based Objective Cognition Testing (CogState) Groton Maze Learning Task (GMLT)|GMLT: a cognitive test which assessed executive function. Participant was shown a 10 multiplied by 10 grid of tiles on a computer touch screen. A 28-step pathway was hidden among 100 possible locations. The participant was instructed to move 1 step from the start location and then continue 1 tile at a time, toward the end to find the pathway. The outcome measure was total number of errors made in attempting to learn the same hidden pathway on 5 consecutive trials at a single session. Score ranges from 0 to infinity. Lower scores meant a better performance.|Baseline, Day 5, 10, 15, 20 of titration phase; Day 21 of stable dosing phase|FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here “n” signifies participants who were evaluable at specified time points for each arm, respectively.||errors||Standard Deviation|Mean
805789|NCT01006122|Other Pre-specified|Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS)|Sheehan-STS is an 8-item clinician/participant administered prospective rating scale and an indicator of trigger assessment that tracks both treatment-emergent suicidal ideation and behaviors). Items 1a, 2-6, 8 scored on 5-point Likert scale (0=not at all, 1=a little, 2=moderately, 3=very, and 4=extremely). Items 1, 1b, 7, an indicator of trigger assessment (TA) require yes/no response. Items included 1= Ever suffer any accident, 1a= Extent plan/intend to hurt yourself, 1b= Intend to die, 2= Wish dead, 3= Want to harm yourself, 4= Think about suicide, 5= Plan for a suicide, 6= Prepare for suicide (PS) with intent to die (ITD), 7= Injure yourself on purpose, 8= Attempt suicide. Result for item 1 indicates if any of the participant ever suffered any accident, 1b indicates if any of the participant intended to die, 7 indicates if any of the participant injured themselves purposely and trigger assessment indicates if any of the participant evoked trigger assessment.|Baseline, Day 5, 10, 15, 20 of titration phase; Day 7, 14, 21 of stable dosing phase|FAS. Here “n” signifies participants who were evaluable at specified time points for each arm, respectively. Results for a parameter are not reported at certain time points since none of the participants were evaluable for the parameter at those time points.||participants|||Number
805790|NCT01006122|Other Pre-specified|Medical Outcomes Study (MOS) Sleep Scale Score|Participant-rated questionnaire to assess sleep quality and quantity. Consists of 12-item questionnaires answered on a range of 1 to 6 for questions (Q) 3 to 12, 1 to 5 for Q1(some questions are reversed so that high score reflects more of the attributes); and Q2 answered on 0 to 24. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range:0 to 100; higher score = greater intensity of attribute. The items contribute to each scale and are averaged to create 7 scale scores and 2 sleep scale index. Scales with at least one item answered was used to generate a scale score. Scales include; sleep disturbance (SD), sleep quantity, snoring, awaken short of breath (ASoB), somnolence, sleep adequacy and optimal sleep; and a 9-item overall sleep problems index(SPI) I and II Subscales range from 0-100 except for sleep quantity (SQ) ranging from0 to 24. Except for sleep quantity, higher scores=greater impairment.|Baseline, Day 5, 10, 15, 20 of titration phase; Day 7, 14, 21 of stable dosing phase|FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here “n” signifies participants who were evaluable at specified time points for each arm, respectively.||units on a scale||Standard Deviation|Mean
805791|NCT01006122|Other Pre-specified|Number of Participants With Electrocardiogram (ECG) Findings|Criteria for potential clinical concern in ECG parameters: maximum PR interval of greater than or equal to (>=) 300 milliseconds (msec), maximum QRS interval >=200 msec, maximum Fridericia’s correction of QT (QTcF) interval of 450 to <480 msec, 480 to <500 msec and >=500 msec. Number of participants who met the criteria for potential clinical concern in ECG findings were reported.|Baseline up to Day 21 of stable dosing phase|Safety analysis set consisted of all participants who received at least 1 dose of study drug. Here “N” (number of participants analyzed) signifies participants who were evaluable for this outcome measure.||participants|||Number
805792|NCT01006122|Other Pre-specified|Number of Participants With Laboratory Abnormalities|Laboratory parameters included hematology (hemoglobin, hematocrit, red blood cell count, platelets, leukocytes, total neutrophils, eosinophils, basophils, lymphocytes, monocytes); liver function (total bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, albumin, total protein); renal function (creatinine, blood urea nitrogen, uric acid, sodium, potassium, chloride, bicarbonate, calcium); urinalysis (protein, blood), and clinical chemistry (glucose). Total number of participants with laboratory abnormalities was reported.|Baseline up to Day 21 of stable dosing phase|Safety analysis set consisted of all participants who received at least 1 dose of study drug. Here “N” (number of participants analyzed) signifies participants who were evaluable for this outcome measure.||participants|||Number
805793|NCT01006122|Other Pre-specified|Number of Participants With Vital Signs Data|Criteria for potential clinical concern in vital signs: supine and standing systolic blood pressure (BP) less than (<) 90 millimeter of mercury (mmHg), supine and standing diastolic BP <50 mmHg, supine and standing heart rate <40 beats per minute (bpm) or >140 bpm. Number of participants who met the criteria for potential clinical concern was reported.|Baseline up to 7-10 days after Day 21 (stable dosing phase)|Safety analysis set consisted of all participants who received at least 1 dose of study drug. Here “N” (number of participants analyzed) signifies participants who were evaluable for this outcome measure.||participants|||Number
805868|NCT01000337|Primary|Changes in the M30 and M65 Markers Related to the Anesthesia Type|Blood samples for determination of the markers M30 and M65 as well as the serum transaminases were collected preoperatively, at the end of surgery, 24 and 48 hours postoperatively.|preoperatively, end of surgery, 24 and 48 hours postoperatively|For an effect size of 0.20 assuming a two-sided error type I error of 0.05 and a power of 0.80, a sample size of 60 sixty patients (30 patients in each group) would be required.||U/L||Standard Deviation|Mean
805794|NCT01006122|Secondary|Clinical Global Impression of Improvement (CGI-I) Scale Score|CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Clinician responded to a question: “Compared to your subject’s condition at the beginning of treatment, how much has your subject changed?”. Improvement was compared to baseline and was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Day 5, 10, 15, 20 of titration phase; Day 7, 14, 21 of stable dosing phase|FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here “N” (number of participants analyzed) signifies participants who were evaluable for this outcome measure and “n” signifies participants who were evaluable at specified time points for each arm, respectively.||units on a scale||Standard Deviation|Mean
805795|NCT01006122|Secondary|Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Day 21 of Stable Dosing Phase|SF-36 is a standardized survey evaluating 8 aspects of functional health and well-being: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality, social functioning (SF), role emotional (RE) and mental health (MH). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline, Day 21 of stable dosing phase|FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here “n” signifies participants who were evaluable at specified time points for each arm, respectively.||units on a scale||Standard Deviation|Mean
805796|NCT01006122|Secondary|Change From Baseline in Cataplexy Episodes at Day 7, 14, 21 of Stable Dosing Phase|Cataplexy is a medical condition in which a person suffers sudden physical collapse though remaining conscious. Cataplexy episodes is number of counts the participant had cataplexy.|Baseline, Day 7, 14, 21 of stable dosing phase|FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here “N” (number of participants analyzed) signifies participants who were evaluable for this outcome measure and “n” signifies participants who were evaluable at specified time points for each arm, respectively.||cataplexy episodes||Standard Deviation|Mean
805797|NCT01006122|Secondary|Change From Baseline in Brief Fatigue Inventory (BFI) Global Score at Day 5, 10, 15, 20 of Titration Phase and Day 7, 14, 21 of Stable Dosing Phase|BFI is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. There are 3 questions that pertain specifically to level of fatigue and 6 questions regarding general activity level, mood and quality of life, all are answered on an 11-point scale, with “0” being “No fatigue at all” to “10” being “As bad as you can imagine”. The global score is calculated by taking the sum of all 9 rating scales for a minimum score of 0 and a maximum score of 90. Higher global scores are associated with more severe fatigue.|Baseline, Day 5, 10, 15, 20 of titration phase; Day 7, 14, 21 of stable dosing phase|FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here “n” signifies participants who were evaluable at specified time points for each arm, respectively.||units on a scale||Standard Deviation|Mean
805798|NCT01006122|Secondary|Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score at Day 5, 10, 15, 20 of Titration Phase and Day 7, 14, 21 of Stable Dosing Phase|ESS is a simple, self-administered questionnaire which provides a measurement of the participant's general level of daytime sleepiness. The participant rates the chance that he/she would fall asleep when in 8 different situations (e.g. sitting and reading, talking to someone, etc.) commonly encountered in daily life on a scale of 0 (no daytime sleep) to 3 (maximum daytime sleep). Total score was the sum of 8 situations ranges from 0 to 24 with a higher score indicating greater daytime sleepiness.|Baseline, Day 5, 10, 15, 20 of titration phase; Day 7, 14, 21 of stable dosing phase|FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here “n” signifies participants who were evaluable at specified time points for each arm, respectively.||units on a scale||Standard Deviation|Mean
805799|NCT01006122|Primary|Change From Baseline in Maintenance of Wakefulness Test (MWT) Score at Day 21 of Stable Dosing Phase|MWT measured ability of participant to remain awake. Participants were instructed to try and remain awake during series of six 20-minute periods in a semi-recumbent position in dark room. Each period was terminated immediately after sleep onset or at end of 20 minutes if no sleep occurred. Poorest outcome was 0 minute the best was 20 minutes.|Baseline, Day 21 of stable dosing phase|"Full analysis set (FAS) consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here N(number of participants analyzed) signifies participants who were evaluable for this outcome measure and n signifies participants who were evaluable at specified time points for each arm."||minutes||Standard Deviation|Mean
805800|NCT01006135|Secondary|Patients With Any Adverse Events||6 months|TS||Number of participants|||Number
805801|NCT01006135|Secondary|Compliance of Patients|Patients are considered to be compliant if the difference of the number of days between visit 1 (baseline) and visit 3 (6months) and the number of actual taken capsules is less than 10.|6 months|Patients from FAS||Number of participants|||Number
805802|NCT01006135|Secondary|Additional Bronchodilator or Inhaled Corticosteroids (ICS)|Pulmonary medication from baseline to visit 3 (6 months)|6 months|Patients from Full Analysis Set (FAS) which includes all patients from the TS who were assessed after administration of Spiriva, i.e. who have evaluable SGRQ measurements at visit 2 or visit 3.||Number of participants|||Number
805803|NCT01006135|Primary|Mean Change of Total Saint George Respiratory Questionnaire (SGRQ) Score at the End of the Observational Period After 6 Months From Baseline|The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life)|Baseline and 6 months|Patients from the treated set (TS) who have evaluable SGRQ measurements at baseline and Visit 3 (6 months)||Units on a scale||Standard Deviation|Mean
805804|NCT00999661|Secondary|Change in Body Mass Index From Baseline to 24 Months|Change in Body Mass Index from Baseline to 24 months with last observation carried forward. The calculation was performed as the Body Mass Index at 24 months minus the Body Mass Index at Baseline.|Baseline to 24 months|||kilograms per meters squared||Standard Deviation|Mean
805805|NCT00999661|Secondary|% Excess Weight Change From Baseline to 12 Months|Percent excess weight change from baseline to 12 months was calculated as (the baseline weight minus the weight at 12 months) divided by the (baseline weight minus the ideal body weight (using the upper limit of the midpoint range in the Metropolitan Tables for Life Insurance, 1983) x 100). Last observation carried forward was used for early terminated subjects.|Baseline to 12 months|Intent to Treat Population||percent of excess weight at baseline||Standard Deviation|Mean
805807|NCT00999687|Primary|Change From Baseline in Single-Hand Nail Psoriasis Severity Index (NAPSI)and in the Modified Target NAPSI for the Single Most Severely Affected Nail of Each Hand at Week 24.|The nail is divided by imaginary horizontal and longitudinal lines into quadrants. Each nail is given a score for nail bed psoriasis (0-4) and nail matrix psoriasis (0-4) depending on the presence of any of the features of nail psoriasis in that quadrant. The NAPSI score evaluates presence of signs in the nail bed (of onycholysis, splinter hemorrhages, nail bed discoloration, and subungual hyperkeratosis) and on the nail matrix (pitting, leukonychia, red spots in the lunula and nail plate crumbling) in all 10 fingernails, providing a minimal score of 0 and a maximum of 80. This study is an intra-patient side-to-side comparison, it measures nail disease on a single hand. All 5 fingers in each group were scored providing a maximum score of 40 and a minimal of 0. The modified target NAPSI score for the target nail scores severity of nail matrix and nail-bed psoriasis from 0 (no sign) to 3 (severe involvement) in each nail quadrant, providing a maximum score of 96 and a minimal of 0.|Baseline and Week 24|Higher values represent a worse outcome. For example, a higher score at baseline and a lower score after treatment represent an improvement.||units on a scale||95% Confidence Interval|Mean
805808|NCT00999687|Primary|Change From Baseline in Single-Hand Nail Psoriasis Severity Index (NAPSI)and in the Modified Target NAPSI for the Single Most Severely Affected Nail of Each Hand at Week 12.|The nail is divided by imaginary horizontal and longitudinal lines into quadrants. Each nail is given a score for nail bed psoriasis (0-4) and nail matrix psoriasis (0-4) depending on the presence of any of the features of nail psoriasis in that quadrant. The NAPSI score evaluates presence of signs in the nail bed (of onycholysis, splinter hemorrhages, nail bed discoloration, and subungual hyperkeratosis) and on the nail matrix (pitting, leukonychia, red spots in the lunula and nail plate crumbling) in all 10 fingernails, providing a minimal score of 0 and a maximum of 80. This study is an intra-patient side-to-side comparison, it measures nail disease on a single hand. All 5 fingers in each group were scored providing a maximum score of 40 and a minimal of 0. The modified target NAPSI score for the target nail scores severity of nail matrix and nail-bed psoriasis from 0 (no sign) to 3 (severe involvement) in each nail quadrant, providing a maximum score of 96 and a minimal of 0.|Baseline and Week 12|Higher values represent a worse outcome. For example, a higher score at baseline and a lower score after treatment represent an improvement.||units on a scale||95% Confidence Interval|Mean
805809|NCT00999804|Secondary|Clinical Response||12 weeks or 24 weeks depending on arm assignment|Participants who have received at least one cycle of therapy (defined as one dose of trastuzumab and 21 days of lapatinib), and have had their response classified were evaluable. 4 participants were not evaluable for efficacy.||participants|||Number
805810|NCT00999804|Secondary|Total Pathologic Complete Response|pathologic complete response was defined as no residual invasive cancer in the breast and the axillary lymph nodes.|12 weeks or 24 weeks depending on arm assignment|Participants who have received at least one cycle of therapy (defined as one dose of trastuzumab and 21 days of lapatinib), and have had their response classified were evaluable. 4 participant were not evaluable: 3 participant were found ineligible for the study and one participant died before surgery.||participants|||Number
805811|NCT00999804|Secondary|Number of Participants With Adverse Events|the safety and tolerability of an extended regimen of lapatinib + trastuzumab, with or without endocrine therapy|12 week or 24 weeks depending on arm assignment|Participants who started the study treatment will be evaluable for safety analysis||participants|||Number
805812|NCT00999804|Primary|Pathologic Complete Response|"Pathologic complete response was defined as no residual invasive cancer in the breast, after 12 or 24 weeks of lapatinib/trastuzumab with or without endocrine therapy.
This outcome is based on patient's pathological report. We are not measuring the clinical response.
Participants who have received at least one cycle of therapy (defined as one dose of trastuzumab and 21 days of lapatinib), and have had their response classified were evaluable."|12 or 24 week depending the arm assignment|Participants who have received at least one cycle of therapy (defined as one dose of trastuzumab and 21 days of lapatinib), and have had their response classified were evaluable. 4 participant were not evaluable: 3 participant were found ineligible for the study and one participant died before surgery.||participants|||Number
805813|NCT00999830|Secondary|Safety Assessment|Adverse Events, Serious Adverse Events, physical examination and biological changes.|from screening visit to the End of Study (at each study visit)|||participants|||Number
805814|NCT00999830|Secondary|Biological Activity of IPH2101 on Killer Immunogloblin Like Receptors (KIR) Occupancy at End of Treatment|KIR-occupancy is a relative measure of the fraction of cell surface KIR that is occupied by the IPH2101 monoclonal antibody, and hence is unavailable for binding to HLA ligands.|From the start up to the end of study (15 months)|||% of occupancy||Full Range|Median
805815|NCT00999830|Primary|Rate of Patients Achieving a Response Based on M-protein or Free Light Chains|"Response was defined:
In patients with a serum M-protein > 5 g/l, as a reduction of at least 25% (minor response according to European society for Blood and Marrow Transplantation (EBMT)) from baseline of serum M-protein confirmed on two consecutive determinations at 4 weeks interval;
In patients with a serum M-protein ≤ 5 g/l and ≥ 3g/l, as a negative electrophoresis
In patients with serum M-protein < 3 g/l but a measurable involved serum free light chains ≥ 100 mg/l and an abnormal Free Light Chains ratio (<0.26 or > 1.65), as a ≥ 50 % decrease in the difference between involved and uninvolved Free Light Chains levels."|From the start of the treatment to the End of Study and during the post study follow up during 2 years according to standard practices|||participants|||Number
805816|NCT00999908|Secondary|Force Vital Capacity (FVC) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) in the 4 Hours After Treatment|FVC was measured with spirometry conducted according to internationally accepted standards. Measurements were made 30, 60, 120, 180, and 240 minutes post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time.|4 hour period following inhalation of study treatment|Intent-to-treat population: All randomized patients who received all the study drugs and had at least 1 post-dose inspiratory capacity measurement within 4 hours after inhalation in each treatment period.||Liters||Standard Deviation|Mean
805869|NCT01000376|Secondary|Safety of Eribulin Administered Alone or Coadministered With Oral Ketoconazole, as Measured by Number of Subjects With Adverse Events.||monitored throughout||||||
805870|NCT01000376|Primary|Mean (SD) Area Under Concentration Time Curve From Zero to Infinity (AUC 0-oo) of Eribulin||7 days after dosing on Days 1 and 15|Pharmacokinetic Population: includes all participants in this crossover study who completed PK evaluations and who had AUC (0-oo) data.||ng*hr/mL||Standard Deviation|Mean
805817|NCT00999908|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) in the 4 Hours After Treatment|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made 30, 60, 120, 180, and 240 minutes post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time.|4 hour period following inhalation of study treatment|Intent-to-treat population: All randomized patients who received all the study drugs and had at least 1 post-dose inspiratory capacity measurement within 4 hours after inhalation in each treatment period.||Liters||Standard Deviation|Mean
805818|NCT00999908|Primary|Peak Inspiratory Capacity Assessed With Spirometry in the 4 Hours After Treatment|During the 4 hours following inhalation of the study treatment, inspiratory capacity (IC) was measured with spirometry conducted according to internationally accepted standards. IC was measured 3 times each at 30, 60, 120, 180, and 240 minutes post-dose and the highest value was reported in liters.|4 hour period following inhalation of study treatment|Per protocol population: All randomized patients who received all the study drugs and had at least 1 post-dose inspiratory capacity measurement within 4 hours after inhalation in each treatment period and who were compliant with the protocol and without any major deviation likely to affect the analysis of pulmonary function measurements.||Liters||Standard Deviation|Mean
805819|NCT00999921|Secondary|Number of Participants Analysed for Response of Cyclical Mastalgia (Good Response Was Defined as Disappearance of Mastalgia)|"All patients who had an increase in breast pain in the perimenstrual period were designated as having cyclical mastalgia. Response was assessed following treatment in terms of either persistence of cyclical mastalgia after 3 months of treatment or disappearance of cyclical mastalgia"|3 months|114 patients were identified as having cyclical mastalgia of whom 58 patients(37 fibroadenosis, 3 fibroadenonomas and 18 mastalgias with no lump) received Tamoxifen and 56 (36 fibroadenosis, 3 fibroadenomas and 17 mastalgias with no lump) received Evening Primrose Oil for 3 months. Good response was defined as disappearance of cyclical mastalgia.||participants|||Number
805820|NCT00999921|Primary|Number of Participants Analysed for Reduction in Mastalgia (Cardiff Breast Pain Score).|All patients were categorized as Grade 0 for no pain, grade 1 for mild pain, grade 2 for moderate pain, Grade 3 for severe pain. Therapeutic response to mastalgia was expressed in terms of Cardiff Breast Pain Score (CBS) where CBS I = excellent response with no pain, CBS II = substantial response, CBS III = poor response and CBS IV = no response|3 months|88 patients treated with Tamoxifen and 47 patients treated with Evening Primrose Oil were assessed for Cardiff Breast Pain Score. Patients with fibroadenomas and those with Grade 0 pain at the beginning of therapy were excluded from this analysis.||participants|||Number
805821|NCT00999921|Primary|Number of Participants Analysed for Reduction in Lump Size ( 60% Reduction in Lump Size Considered to be a Satisfactory Response)|Ultrasonography of the breast was used to ascertain the lump size at the beginning of therapy and a repeat Ultrasonography of breast was done after 3 months at the end of the proposed therapy to record the posttreatment lump size by the same operator. The difference between the two findings were recorded and noted and a 60% or more reduction in the size of the lump was considered as a satisfactory response.|3 months|102(out of 127) patients receiving Tamoxifen and 99(out of 129) receiving Evening Primrose Oil were assessed for reduction in lump size. The remaining patients had mastalgia with no lump, hence were excluded from this assessment. A 60% or more reduction in lump size after completion of the therapy was considered as a satisfactory response.||participants|||Number
805822|NCT01000025|Secondary|Number of Participants With Toxicity as Measured by NCI CTCAE Version 4.0|Number of participants with Toxicities by treatment received according to NCI CTCAE version 4.0|42 Months|As treated population||participants|||Number
805823|NCT01000025|Secondary|Objective Response Rate|Response were evaluated in this study using the revised international criteria (1.1) proposed by the RECIST (Response Evaluation Criteria in Solid Tumours) committee. BEST RESPONSE from the start of study treatment until the end of treatment were reported.Objective response rate is the sum of CR + PR divided by the total number of patients in each group.|42 months|ITT||percentage of participants||95% Confidence Interval|Mean
805824|NCT01000025|Secondary|Progression-free Survival|progression were evaluated using the revised international criteria (1.1) proposed by the RECIST (Response Evaluation Criteria in Solid Tumours) committee|42 Months|ITT||Months||95% Confidence Interval|Median
805825|NCT01000025|Secondary|Overall Survival in EGFR-mutant Patients|Overall survival by EGFR-mutantion subgroups|42 Months|Patients with EGFR mutation||Months||95% Confidence Interval|Median
805826|NCT01000025|Secondary|Overall Survival in KRAS-WT Patients|Median and 95% confidence intervals of Overall survival in KRAS-WT patients|42 Months|Patients with K-Ras mutation wild type||Months||95% Confidence Interval|Median
805827|NCT01000025|Primary|Overall Survival|Median and 95% confidence intervals|42 Months|ITT||Months||95% Confidence Interval|Median
805828|NCT01000064|Secondary|The Study Will Utilize fMRI Methods (as Well as Aforementioned Neurobehavioral Measures) to Elucidate Neural Mechanisms of Response.||12 weeks|Based on the analysis of neurobehavioral assessment data, complications with screening, and limited sample size, the neural mechanisms of response to Vyvanse vs placebo were not significant enough to be measured and compared by fMRI. There is no data from the fMRI to be reported because it was abandoned as an aspect of this study before analysis.|||||
805829|NCT01000064|Secondary|Evaluation of Which Types of Patients Are Most Likely to Benefit From Treatment||12 weeks|No data were collected.|||||
805830|NCT01000064|Primary|"Assessment of Various Components of Attention, Related Cognitive Processes and ADHD Symptoms, Using the Behaviour Rating Inventory of Executive Function-Adult Version (BRIEF-A) Organization of Materials Sub-scale."|"The BRIEF-A is a standardized rating scale developed to observe everyday behaviors associated with specific domains of the executive functions in adults ages 18 to 90 years. The Organization of Materials scale measures orderliness of work, living, and storage spaces.
T-scores (M = 50, SD = 10) are used to interpret the individual’s level of executive functioning on the BRIEF-A, with higher scores indicating more difficulty in a particular area."|12 weeks|||t-scores||Standard Deviation|Mean
805871|NCT01000376|Primary|Mean (SD) Maximum Observed Concentration (Cmax) of Eribulin||7 days after dosing on Days 1 and 15|Pharmacokinetic Population: includes all participants in this crossover study who completed PK evaluations and who had Cmax data.||ng*mL||Standard Deviation|Mean
814122|NCT01084265|Primary|Number of Participants Who Had at Least One Follicle Greater Than 17mm in Diameter||Day 14|Per protocol set included all participants who completely met all the requirements of clinical trial protocol.||participants|||Number
805831|NCT01000064|Primary|"Assessment of Various Components of Attention, Related Cognitive Processes and ADHD Symptoms, Using the Conners Adult ADHD Rating Scale: Long Form (CAARS:L) Inattention/Memory Problems Sub-scale."|"The CAARS:L is an assessment tool that prompts an observer to provide valuable information about the client. This instrument is helpful when considering a diagnosis of ADHD or related problem. High scores on the Inattention/Memory Problems sub-scale may indicate difficulty in concentration, difficulty planning or completing tasks, forgetfulness, absent-mindedness, and/or being disorganized.
T-scores (M = 50, SD = 10) are used to measure ratings with higher t-scores indicating greater inattention and memory problems. When a t-score is around 60, this indicates greater risk."|12 weeks|||t-scores||Standard Deviation|Mean
805832|NCT01000064|Primary|Assessment of Various Components of Attention, Related Cognitive Processes and ADHD Symptoms, Using the Wechsler Adult Intelligence Scale -- Fourth Edition (WAIS-IV) Digit Span-Backward Subtest.|Digit Span repeats strings of digits of increasing length said by the examiner in the same (forward) and in reverse (backward) order. It measures working memory and concentration with a range of scaled scores from 1-19, with higher scaled scores indicating better performance when compared to population norms.|12 weeks|||units on a scale||Standard Deviation|Mean
805833|NCT01000064|Primary|Assessment of Various Components of Attention, Related Cognitive Processes and ADHD Symptoms, Using Conners Continuous Performance Task (CPT-II).|"Conner's Continuous Performance Task (CPT-II) measure sustained attention and response inhibition.
CPT-II Hit Reaction Time (RT) Standard Error (SE) measures inattention. Consistency of response times is measured by the standard error for responses to targets. Higher values indicate a greater amount of inattention."|12 weeks|||ms||Standard Deviation|Mean
805834|NCT01000064|Primary|Assessment of Various Components of Attention, Related Cognitive Processes and ADHD Symptoms, Using Conners Continuous Performance Task (CPT-II)|"Conner's Continuous Performance Task (CPT-II) measure sustained attention and response inhibition.
CPT-II Hit Reaction Time (RT) Inter-Stimulus Interval (ISI) Change assesses the ability to adapt to changing inter-stimulus intervals. Inter-stimulus intervals refers to the amount of time between presentation of stimuli. High t-scores indicate that RT increased as the ISI increased; negative values indicate that RT decreased as the ISI increased.
Less Hit RT ISI Change indicates less variability in RT depending on the speed of presentation."|12 weeks|||t-scores||Standard Deviation|Mean
805835|NCT01000064|Primary|Assessment of Various Components of Attention, Related Cognitive Processes and ADHD Symptoms, Using Conners Continuous Performance Task (CPT-II).|"Conner's Continuous Performance Task (CPT-II) measure sustained attention and response inhibition.
CPT-II Hit Reaction Time (RT) Block Change measures inattention and vigilance. Lower values indicate less slowing in RT as the test progressed. High T-scores indicate decreased vigilance over time."|12 weeks|||t-scores||Standard Deviation|Mean
805836|NCT01000064|Primary|Assessment of Various Components of Attention, Related Cognitive Processes and ADHD Symptoms, Using Conners Continuous Performance Task (CPT-II).|"Conner's Continuous Performance Task (CPT-II) measure sustained attention and response inhibition.
CPT-II Preservations represent responses in which reaction time was less than 100 ms; these responses are assumed to be anticipatory, random, or slow/inattentive (i.e., carried over from the previous response) because it is physiologically impossible to respond accurately in so short a time. Higher T-scores, percentiles, and means indicate worse performance."|12 weeks|||ms||Standard Deviation|Mean
805837|NCT01000155|Secondary|γ-globin to β-globin Ratio|Levels of peripheral blood γ-globin to β-globin messenger RNA were estimated based on established methods. The ratio of γ-globin to β-globin was then calculated.|Measured at baseline and end of treatment, up to 16 weeks.|The analysis dataset is comprised of all treated patients.||Change in γ-globin to β-globin ratio||Full Range|Median
805838|NCT01000155|Secondary|F-Cell Percentage Level|F-cell percentage levels were estimated based on established methods.|Measured at baseline and end of treatment, up to 16 weeks.|The analysis dataset is comprised of all treated patients.||F-cell percentage||Full Range|Median
805839|NCT01000155|Primary|Percent Fetal Hemoglobin (HbF%) Induction Success Rate|Success will be defined by comparing the maximum HbF% on study drug to the HbF% at baseline. An absolute increase in HbF% of 4% of more, or an increase to 100% or more of baseline in patients with HbF under 4% at baseline will be considered a success. HbF% induction success rate is calculated as the count of successes divided by the count of patients in the analysis population.|HbF% was measured at baseline and weekly on treatment. Median duration of treatment was 3 months.|The analysis dataset is comprised of all treated patients.||proportion of patients||90% Confidence Interval|Number
805840|NCT01000285|Secondary|Effects of HTLV-1 Integration Sites After Treatment||6 months|||number of integration sites||Standard Error|Mean
805841|NCT01000285|Secondary|Effects of HTLV-1 Integrase Gene Sequence After Treatment as Measured by Nucleotide Divergence||6 months|||percentage of nucleotide divergence||Standard Error|Mean
805842|NCT01000285|Secondary|Effects of HTLV-1 RNA Load After Treatment as Measured by Hbz Messenger RNA||6 months|||copies/peripheral blood mononuclear cell||Standard Error|Mean
805843|NCT01000285|Secondary|Relation of NFκB Gene Expression Profile on Response|Standard error represents the standard error of the fold expression of protein coding transcripts for each gene indicated.|6 months|Average RPKM values normalized to Patient A before therapy.||fold expression||Standard Error|Mean
805844|NCT01000285|Secondary|Effects of on HTLV-1 DNA After Treatment as Measured by Proviral Loads||6 months|||copies/peripheral blood mononuclear cell||Standard Error|Mean
805845|NCT01000285|Secondary|Time to Progression|-The progression definitions used for this study are from the 2007 Cheson criteria.|Up to 4 years following completion of therapy|12 out of the 18 participants had a complete or partial response.||days||Full Range|Median
805846|NCT01000285|Primary|Efficacy of Treatment as Measured by Best Overall Response|-The response definitions used for this study are the 2007 Cheson criteria.|Up to 4 years following completion of therapy|||participants|||Number
805847|NCT01000285|Primary|Tolerability of Treatment as Measured by Number of Participants With Grade 3 or Higher Adverse Events|The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for all toxicity reporting.|Up to 30 days after completion of treatment|||participants|||Number
805922|NCT01006889|Secondary|Percent Change From Baseline in Glucose Infusion (M Value) During Hyperglycemic Clamp|M value represents glucose infusion change|6 months|The number of participants included were the ones that completed the study.||percentage change vs pretreatment||Standard Deviation|Mean
805848|NCT01000311|Secondary|Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations|"Safety of the study vaccines (MenACWY-CRM and other routine vaccines) was assessed in terms of the number of subjects who reported adverse events (AEs) and/or serious AEs per vaccine group at the following time points: entire study period, after infants vaccination (up to 7 months), between 2- and 4-months, between 4- and 6-months, between 6- and 12-months, between 7- and 12-months, 28 days after 12-month vaccination, and between 29 days after 12-month vaccination and study termination.
Solicited reactions were not collected during this study. The safety analyses also included any AEs observed by study personnel within 15 minutes following vaccination. All AEs and SAEs were judged by the investigator as whether probably related, possibly related, or not related to vaccine."|From day 1 to 18 months|Analysis was performed on the safety dataset, i.e. all subjects in the exposed population who provided postbaseline safety data||Number of subjects|||Number
805849|NCT01000311|Secondary|Percentage of Subjects With Four-fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM|The immune response was measured as the percentage of subjects who achieved four-fold increase in hSBA titers against meningococcal serogroup A, C, W and Y one month after toddler dose of MenACWY-CRM administered at 12 months of age as compared to hSBA titers before the toddler vaccination.|One month after MenACWY-CRM toddler vaccination|Analysis was performed on the PP toddler dataset for MenACWY-CRM.||Percentage of subjects||95% Confidence Interval|Number
805850|NCT01000311|Secondary|Persistence of hSBA Geometric Mean Titers Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination|The antibody persistence was measured as the hSBA GMTs directed against meningococcal serogroup A, C, W and Y, at baseline and six months after third infant dose of MenACWY-CRM administered at 6 months (12 months of age), before administration of the toddler dose of MenACWY-CRM.|Baseline and Six months after third infant dose of MenACWY-CRM|Analysis was performed on the PP toddler dataset for MenACWY-CRM.||Titers||95% Confidence Interval|Geometric Mean
805851|NCT01000311|Secondary|Antibody Persistence by Percentage of Subjects With hSBA Titers ≥1:8 Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination|The antibody persistence was measured as the percentage of subjects with hSBA titers ≥1:8 against meningococcal serogroup A, C, W and Y, at baseline and six months after third infant dose of MenACWY-CRM administered at 6 months (12 months of age), before administration of the toddler dose of MenACWY-CRM.|Baseline and Six months after third infant dose of MenACWY-CRM|Analysis was performed on the PP toddler dataset for MenACWY-CRM.||Percentage of subjects||95% Confidence Interval|Number
805852|NCT01000311|Secondary|Percentage of Subjects With Anti-pneumococcal Antigen Antibodies ≥0.35 μg/mL One Month After Toddler Vaccination With PCV Administered With MenACWY-CRM Compared With PCV Given Alone|The immune seroresponse was measured as the percentage of subjects with anti-pneumococcal antigen antibodies ≥0.35 μg/mL against pneumococcal antigens PnC 4, 6B, 9V, 14, 18C, 19F and 23F, one month after toddler dose of PCV at 12 months of age when administered concomitantly with MenACWY-CRM compared with PCV given alone.|One month after PCV toddler vaccination|Analysis was performed on the PP pneumococcal toddler population.||Percentage of subjects||95% Confidence Interval|Number
805853|NCT01000311|Secondary|Geometric Mean Concentrations Of Antibodies Against Pneumococcal Antigens One Month After Toddler Vaccination With PCV Administered With MenACWY-CRM Compared With PCV Given Alone|Immunogenicity was measured as the GMCs of anti-pneumococcal antibodies against pneumococcal antigens PnC 4, 6B, 9V, 14, 18C, 19F and 23F, one month after toddler dose of PCV at 12 months of age administered concomitantly with MenACWY-CRM compared with PCV given alone.|One month after PCV toddler vaccination|Analysis was performed on the PP pneumococcal toddler population.||μg/mL||95% Confidence Interval|Geometric Mean
805854|NCT01000311|Secondary|Geometric Mean Concentrations Of Antibodies Against Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone|The immune response was measured as the geometric mean concentrations (GMCs) of antibodies directed against diphtheria, tetanus, pertussis (PT, FHA, Pertactin, FIM), hepatitis B, Hib, polio (type 1, 2 and 3) and pneumococcal (PnC 4, 6B, 9V, 14, 18C, 19F and 23F) antigens when routine vaccines are administered concomitantly with MenACWY-CRM compared with when routine vaccines are given alone, one month after 3 doses of infant series vaccination at 2, 4 and 6 months of age.|One month after third dose of routine infant series vaccination|Analysis was performed on the PP datasets of infants for concomitant, pertussis and hepatitis B vaccinations||μg/mL||95% Confidence Interval|Geometric Mean
805855|NCT01000311|Secondary|Percentage of Subjects With Seroresponse to Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone|"The immune seroresponse to routine concomitant vaccination was measured as the percentages of subjects with pre-specified cut-off limit of ≥0.1 IU/mL (Diphtheria and Tetanus); ≥0.15 μg/mL (Hib); ≥0.35 μg/mL (Pneumococcal antigens, PnC); and ≥10 mIU/mL (Hepatitis B), evaluated using enzyme-linked immunosorbent assay (ELISA) at one month after 3 doses of infant series vaccination administered at 2, 4 and 6 months of age.
The immune response to pertussis antigens (PT, FHA, Pertactin, FIM) was measured as percentage of subjects with seroresponse (in initially seronegative infants, ≥4 times the lower limit of quantification (LLQ); in initially seropositive infants, at least 4 times prevaccination concentration) by ELISA and percentage of subjects with titer ≥1:8 (Polio types 1, 2, and 3) by neutralization test (NT) one month after 3 doses of infant series vaccination administered at 2, 4 and 6 months of age."|One month after third dose of routine infant series vaccination|Analysis was performed on the PP concomitant, pertussis and hepatitis B infant populations.||Percentage of subjects||95% Confidence Interval|Number
805856|NCT01000311|Secondary|hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM|Immunogenicity was measured as the hSBA GMTs directed against meningococcal serogroups A, C, W and Y before (baseline) and one month after 3 infants doses of MenACWY-CRM administered at 2, 4 and 6 months of age.|Baseline and one month after third infant dose of MenACWY-CRM|Analysis was performed on the PP dataset of MenACWY-CRM infant vaccination series.||Titers||95% Confidence Interval|Geometric Mean
805923|NCT01006889|Secondary|Insulin Secretion (Hyperglycemic Clamp)|Change in C-peptide levels vs. pretreatment in the first and second phase.|6 months|The number of participants included were the ones that completed the study.||ng/ml||Standard Deviation|Mean
805857|NCT01000311|Secondary|Percentage of Subjects With hSBA Titers ≥1:8, and Four-Fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM|"Immunogenicity was measured as the percentage of subjects with hSBA titers ≥1:8 against meningococcal serogroup A, C, W and Y, before (baseline) and one month after 3 infant doses of MenACWY-CRM administered at 2, 4 and 6 months of age.
Percentage of subjects who achieved at least four-fold rise in hSBA titers against serogroup A, C, W and Y was measured one month after 3 infant doses of MenACWY-CRM."|Baseline and one month after third infant dose of MenACWY-CRM|Analysis was performed on the PP dataset of MenACWY-CRM infant vaccination series.||Percentage of subjects||95% Confidence Interval|Number
805858|NCT01000311|Secondary|hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM|Immunogenicity was measured as the hSBA geometric mean titers (GMTs) directed against meningococcal serogroup A, C, W and Y, at baseline and one month after toddler dose of MenACWY-CRM administered at 12 months of age.|Baseline and one month after fourth-dose of MenACWY-CRM|Analysis was performed on the PP toddler dataset for MenACWY-CRM vaccination.||Titers||95% Confidence Interval|Geometric Mean
805859|NCT01000311|Primary|Percentage of Subjects With hSBA Titer ≥1:8 Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM|"Immunogenicity was measured as the percentage of subjects who achieved hSBA titer ≥1:8 against meningococcal serogroup A, C, W and Y, evaluated by serum bactericidal assay using human complement (hSBA), at baseline and one month after toddler dose of MenACWY-CRM administered at 12 months of age.
The immune response was considered sufficient if the lower limit of the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8, at one month after toddler vaccination, was greater than 85% for the serogroup C, W, or Y and greater than 80% for the serogroup A."|Baseline and one month after fourth-dose of MenACWY-CRM|Analysis was done on the per-protocol (PP) toddler dataset for MenACWY-CRM, i.e. the subjects who received all the relevant doses of vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violation as defined prior to database lock.||Percentage of subjects||95% Confidence Interval|Number
805860|NCT01000324|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|A serious adverse event is any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, or was a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|Up to Year 20.|The analysis was performed on LT Total cohort that included all subjects who returned at each annual time point and who belonged to the Total Vaccinated cohort in the primary study.||Subjects|||Number
805861|NCT01000324|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|A serious adverse event was any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|During the 31-day (Day 0 to 30) period after administration of the challenge dose at Year 19.|The analysis was performed on LT Total cohort that included all subjects who returned at each annual time point and who belonged to the Total Vaccinated cohort in the primary study||Subjects|||Number
805862|NCT01000324|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE).|An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 31-day (Day 0 to 30) period after administration of the challenge dose at Year 19.|The analysis was performed on LT Total cohort that included all subjects who returned at each annual time point and who belonged to the Total Vaccinated cohort in the primary study||Subjects|||Number
805863|NCT01000324|Secondary|Anti-hepatitis B Virus (Anti-HBs) Antibody Concentration|Concentrations are given as Geometric Mean Concentrations (GMCs) expressed as mIU/mL.|At Year 18, 14 days and 30 days post challenge dose (Year 19)|The analysis was performed on LT Total cohort that included all subjects who returned at each annual time point and who belonged to the Total Vaccinated cohort in the primary study||milli-international units per milliliter||95% Confidence Interval|Geometric Mean
805864|NCT01000324|Secondary|Number of Subjects With Immune Response to the Challenge Vaccine Antigen|None of the subjects received a challenge dose at Years 16, 17, 18 and 20 while, one subject received the challenge dose at Year 19.|Before, 14 days and one month after the challenge dose at Year 19.|The analysis was performed on LT Total cohort that included all subjects who returned at each annual time point and who belonged to the Total Vaccinated cohort in the primary study||Subjects|||Number
805865|NCT01000324|Primary|Anti-HAV and Anti-HBs Geometric Mean Concentrations (GMCs)|Concentrations were expressed as GMCs in mIU/mL.|At Years 16, 17, 18, 19 and 20.|The analysis was performed on the Long-Term (LT) According-to-Protocol (ATP) cohort for analysis of immunogenicity.They were included in the ATP analysis for the primary study, did not receive hepatitis A or B vaccination that was not specified in the protocol and were not eliminated for abnormal increase of antibody concentrations.||milli-international units per milliliter||95% Confidence Interval|Geometric Mean
805866|NCT01000324|Primary|Number of Subjects Seropositive for Anti-hepatitis A Virus Antibodies (Anti-HAV) and Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies and With Anti-HBs Antibody Concentrations >= 10 Milliinternational Units Per Milliliter (mIU/mL).|Seropositivity for anti-HAV antibodies is defined as antibody concentrations >= 15 milliinternational units per milliliter (mIU/mL). Seropositivity for anti-HBs antibodies is defined as antibody concentrations >= 6.2 mIU/mL.|At Years 16, 17, 18, 19 and 20.|The analysis was performed on the Long-Term (LT) According-to-Protocol (ATP) cohort for analysis of immunogenicity. They were included in the ATP analysis for the primary study, did not receive hepatitis A or B (hep A/B) vaccination that was not specified in the protocol and were not eliminated for abnormal increase of antibody concentrations.||Subjects|||Number
805867|NCT01000337|Secondary|Transaminases||February 2011||||||
805872|NCT01000480|Secondary|Number of Participants With an Objective Tumor Response|Participants with confirmed complete response (CR), confirmed partial response (PR), stable disease (SD), or progressive disease (PD) according to Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria, as well as participants with a not evaluable/tumor response unknown. CR: disappearance of all tumor lesions. PR: either a) at least a 30% decrease in sum of longest diameter (LD) of target lesions taking as a reference baseline sum LDs, or b) complete disappearance of target lesions, with persistence (not worsening) of 1 or more nontarget lesions. In either case, no new lesions appeared. SD: small changes that did not meet above criteria. PD: at least a 20% increase in sum of LD of target lesions taking as reference smallest sum LD recorded since treatment started or appearance of 1 or more new lesions. Participants who discontinued study treatment (for reasons other than progression) before entering concurrent phase were considered to have non-evaluable response.|Date of first dose through end of follow-up [up to 30 weeks (1 cycle=21 days)]|Intent-to-treat population: Participants who received at least 1 dose of study drug (pemetrexed or cisplatin).||participants|||Number
805873|NCT01000480|Secondary|Overall Survival|Overall survival (OS) was the duration from enrollment to death due to any cause. Participants who were alive were censored at the last contact.|Date of first dose to date of death (up to 35.4 months)|Intent-to-treat population: participants who received at least 1 dose of study drug (pemetrexed or cisplatin). The number of participants censored was 45.||months||95% Confidence Interval|Median
805874|NCT01000480|Primary|1 Year Progression Free Survival|Progression free survival (PFS) was defined as the time from study enrollment to the first observation of progressive disease (PD) or death from any cause. For participants not known to have died as of the data cut-off date and who did not have objective PD, PFS was censored at the date of the last objective progression-free disease assessment. For participants who received subsequent systemic anticancer therapy (after discontinuation from the study drug) prior to objectively determined PD or death, PFS was censored at the date of the last objective progression-free disease assessment prior to start of postdiscontinuation chemotherapy. If a participant did not have a complete baseline disease assessment, then PFS was censored at the enrollment date, regardless whether or not objectively determined PD or death had been observed for the participant.|Date of first dose to date of objectively determined PD or death [every cycle up to 4 cycles and then every 3 months up to 1 year (1 cycle=21 days)]|Intent-to-treat population: participants who received at least 1 dose of either study drug (pemetrexed or cisplatin). The number of participants censored was 35.||percentage of participants||95% Confidence Interval|Number
805875|NCT01000493|Secondary|Number of Participant by Maximum Suicidal Ideation, Based on the C-SSRS During and Post Treatment|The C-SSRS used to assess severity and change of suicidality by integrating both behavior and ideation and to be completed by the participants. The SSRS track change in the severity/density of suicidality. It assessed intensity of ideation (a potentially important marker of severity), specifically asking about frequency, duration, intrusiveness, controllability, and deterrents. The interview was initiated with 5 (yes/no) questions; rated on 1-5 point scale, presented in ascending order of severity, about suicidal ideation. The clinician asked 5 questions: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation without intent to act, active suicidal ideation with any methods (not plan) without intent to act and active suicidal ideation with specific plan and intent. Participants analyzed were number of participants with at least one C-SSRS assessment after the first dose of study medication (that is on treatment or post treatment).|Baseline, Week 1, 2, 4, 6, 8, 10, 12 and Day 14 of follow-up (approximately 14 weeks)|All subject population. Only those participants available at the time of indicated time points were analyzed.||Participants|||Number
805876|NCT01000493|Secondary|Number of Participant With Suicidal Behavior Based on the Columbia Suicide Severity Rating Scale (C-SSRS) During and Post Treatment|The C-SSRS used to assess severity and change of suicidality by integrating both behavior and ideation and to be completed by the participants. The SSRS track change in the severity/density of suicidality. The interview was initiated with 5 (yes/no) questions; rated on 1-5 point scale, presented in ascending order of severity, about suicidal ideation. If the answers to the first 2 ideation questions were “yes,” the clinician asked questions 3-5. If the answers to ideation questions 1 and 2 were “no,” then the clinician proceeded to 5 (yes/no) questions that addressed suicidal behavior, which was categorized as actual attempt, engaged in non-suicidal self-injurious behavior, interrupted attempt, aborted attempt and preparatory acts or behaviors. Participants analyzed were number of participants with at least one C-SSRS assessment after the first dose of study medication (that is on treatment or post treatment).|Baseline, Week 1, 2, 4, 6, 8, 10, 12 and Day 14 of follow-up (approximately 14 weeks)|All subject population. Only those participants available at the time of indicated time points were analyzed.||Participants|||Number
805877|NCT01000493|Secondary|Change From Baseline in MSFQ Items (Diminished/Absent Libido; Arousal Difficulties; Orgasm Difficulties/Anorgasmia and Degree of Sexual Satisfaction) Scores|The MSFQ was derived from the Guided Interview Questionnaire for males and from the Arizona Sexual Experience Scale. The questionnaire includes five items with a score ranging from 1-6 (1: greater than normal; 2: normal; 3: minimally diminished; 4: moderately diminished; 5: markedly diminished and 6: totally absent). The areas of sexual functioning included were diminished/absent libido; arousal difficulties; orgasm difficulties/anorgasmia and degree of sexual satisfaction. A follow-up version of the questionnaire includes an additional sixth item of the participant’s global impression of improvement, with a score ranging from 1 to 6. It was assessed at Baseline, Week 1, 2, 4, 6, 8, 10 and 12. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. Baseline was defined as value on Day 1 (pre-dose).|Baseline (Day 1 pre-dose) and up to Week 12|All subject population. Only those participants available at the specified time points were analyzed.||Score on a scale||Standard Deviation|Mean
805924|NCT01006889|Secondary|Number of Severe Hypoglycemic (Glucose ≤40 mg/dL) Events.||6 months|The number of participants included were the ones that completed the study.||number of events|||Number
805925|NCT01006889|Secondary|Change in Anthropometric Variables (Weight).||6 months|The number of participants included were the ones that completed the study.||Kg||Standard Deviation|Mean
805926|NCT01006889|Secondary|A1c|Patients with controlled T2DM with bedtime insulin alone (n=5) or bedtime insulin and premeal rapid-acting insulin novolog (n=15) had eventide given twice daily for 6 months (if on premeal insulin it was stopped). The goal is to assess if adding SQ exenatide is effective to maintain optimal glycemic control in this population.|6 months|The number of participants included were the ones that completed the study.||percentage of A1c||Standard Deviation|Mean
805878|NCT01000493|Secondary|Change From Baseline in MSFQ Total Score in Females|The MSFQ was derived from the Guided Interview Questionnaire for males and from the Arizona Sexual Experience Scale. The questionnaire includes five items with a score ranging from 1-6 (1: greater than normal; 2: normal; 3: minimally diminished; 4: moderately diminished; 5: markedly diminished and 6: totally absent with total score 5-30; higher score indicating more dysfunction). The areas of sexual functioning included were total score used as a global measure of sexual dysfunction. A follow-up version of the questionnaire includes an additional sixth item of the participant’s global impression of improvement, with a score ranging from 1 to 6. It was assessed at Baseline, Week 1, 2, 4, 6, 8, 10 and 12. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. Baseline was defined as value on Day 1 (pre-dose).|Baseline (Day 1 pre-dose) and up to Week 12|Female participants from all subject population used. Only those participants available at the specified time points were analyzed.||Score on a scale||Standard Deviation|Mean
805879|NCT01000493|Secondary|Change From Baseline in Massachusetts Sexual Function Questionnaire (MSFQ) Total Score and Erectile Dysfunction Score in Males|The MSFQ was derived from the Guided Interview Questionnaire for males and from the Arizona Sexual Experience Scale. The questionnaire includes five items with a score ranging from 1-6 (1: greater than normal; 2: normal; 3: minimally diminished; 4: moderately diminished; 5: markedly diminished and 6: totally absent with total score 5-30; higher score indicating more dysfunction). The areas of sexual functioning included were total score and erectile dysfunction (males only). A total score was used as a global measure of sexual dysfunction. A follow-up version of the questionnaire includes an additional sixth item of the participant’s global impression of improvement, with a score ranging from 1 to 6. It was assessed at Baseline, Week 1, 2, 4, 6, 8, 10 and 12. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. Baseline was defined as value on Day 1 (pre-dose).|Baseline (Day 1 pre-dose) and up to Week 12|Male participants from all subject population used. All subject population defined as participants who received at least one dose of study medication. Only those participants available at the specified time points were analyzed.||Score on a scale||Standard Deviation|Mean
805880|NCT01000493|Secondary|Change From Baseline in the Cognitive and Physical Function Questionnaire (CPFQ) Total Score, by Visit Week|The Massachusetts CPFQ was a brief self-report scale to measure cognitive and executive dysfunction in mood and anxiety disorders. The CPFQ comprises 7 questions assessing each of the most common complaints of depressed participants reporting fatigue or cognitive/executive problems. Each question was rated on a scale of 1 to 6, with 1: greater than normal, 2: normal, 3: minimally diminished, 4: moderately diminished, 5: markedly diminished and 6: totally absent functioning with total score 7-42; higher score indicating more dysfunction. It was assessed at Baseline, Week 1, 2, 4, 6, 8, 10 and 12. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. Baseline was defined as value on Day 1 (pre-dose).|Baseline (Day 1 pre-dose) and up to Week 12|ITT population. Only those participants available at the specified time points were analyzed.||Score on a scale||Standard Deviation|Mean
805881|NCT01000493|Secondary|Change From Baseline in Hamilton Depression Rating Scale (HAM-D), by Visit Week|The HAM-D was observer-rated depressive symptom rating scale to measure the severity of depressive symptoms in participants with primary depressive illness. The items were ranked on a scale of 0-4 (0: absent; 4: greatest severity) or 0-2 (0: no difficulty; 2: difficulty falling asleep). In addition to the total score (0-66; with higher score indicates more depression), the HAM-D anxiety factor score (sum of items 10, 11, 12, 13, 15 and 17) and the melancholia subscore (sum of items 1, 2, 7, 8, 10, and 13) of the 17-item HAM-D scale was analyzed. The melancholia subscale was derived from three formal psychometric criteria (calibration, ascending monotonicity and dispersion). It was assessed at Baseline, Week 1, 2, 4, 6, 8, 10 and 12. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. Baseline was defined as value on Day 1 (pre-dose).|Baseline (Day 1 pre-dose) and up to Week 12|ITT population. Only those participants available at the specified time points were analyzed.||Score on a scale||Standard Error|Least Squares Mean
805882|NCT01000493|Secondary|Change From Baseline in the CAPS Recurrent Distressing Dreams Item (B2) at Weeks 1, 4, 8, and 12|The B2 asked participant about ‘Have you ever had unpleasant dreams about the event(s)? How often in the past month?’ Both frequency (0: never; 4: daily or all the time) and ‘at their worst, how much distress or discomfort did these dreams cause you? Did these dreams wake you up? [If yes, ask:] What were you feeling or doing when you awoke? How long does it usually take to get back to sleep? [Listen for report of panic symptoms, yelling, posturing] intensity (0: none or no problem with symptoms; 4: extreme, incapacitating) ratings were made on a 5-point scale. The total score 0-8, higher scores means more severity. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. Baseline was defined as value on Day 1 (pre-dose).|Baseline (Day 1 pre-dose) and up to Week 12|ITT population. Only those participants available at the specified time points were analyzed.||Score on a scale||Standard Deviation|Mean
805883|NCT01000493|Secondary|Change From Baseline in the PSQI Addendum for PTSD (PSQI-A) Global Score, by Visit Week|The PSQI-A was self-report instrument to assess disruptive nocturnal behavior (DNB) in PTSD participants with 7 types of DNB. These items include frequency of 1: hot flashes, 2: general nervousness, 3: memories or nightmares of traumatic experience, 4: severe anxiety or panic, not related to traumatic memories, 5: bad dreams, not related to traumatic memories, 6: episodes of terror or screaming during sleep without fully awakening and 7: episodes of acting out dreams, such as kicking, punching, running, or screaming. Each item was rated on a scale (0: not in the past month, 1: less than once a week, 2: once or twice a week and 3: three or more times a week) with global score range of 0-21. It was assessed at Baseline, Week 1, 2, 4, 6, 8, 10 and 12. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. Baseline was defined as value on Day 1 (pre-dose).|Baseline (Day 1 pre-dose) and up to Week 12|ITT population. Only those participants available at the specified time points were analyzed.||Score on a scale||Standard Deviation|Mean
805927|NCT01006889|Primary|Hepatic Steatosis|Hepatic steatosis was assessed non-invasively by MRS.|6 months|The number of participants included were the ones that completed the study.||Percentage of liver fat||Standard Deviation|Mean
806022|NCT01008449|Secondary|Composite Cosmesis Score (Stony Brook Scar Evaluation Score - SBSES) Core - SBSES))|The SBSES assessed five scar components: width, height, color, suture marks and overall appearance. Each component was assigned a score of 0 or 1 with a total sum range of 0 (worst) to 5 (best).|at the end of follow up, 4 - 6 weeks post partum|||units on a scale||Inter-Quartile Range|Median
805884|NCT01000493|Secondary|Change From Baseline in the Pittsburgh Sleep Quality Index (PSQI) Global Score, by Visit Week|The PSQI was a self-rated questionnaire to assess sleep quality and disturbances. Individual items (19) generate 7-component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication and daytime dysfunction. The global score generated by addition of individual score excluding use of sleeping medication component. It contains 15 objective (about frequency of sleep disturbances and subjective sleep quality) and 4 subjective (typical bedtime, wake-up time, sleep latency and sleep duration) items with score range from 0: no to 3: severe difficulty. The PSQI Global Score ranges from 0 to 21 and a global score > 5 was suggestive of significant sleep disturbance. It was assessed at Baseline, Week 1, 2, 4, 6, 8, 10 and 12. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. Baseline was defined as value on Day 1 (pre-dose).|Baseline (Day 1 pre-dose) and up to Week 12|ITT population. Only those participants available at the specified time points were analyzed.||Score on a scale||Standard Deviation|Mean
805885|NCT01000493|Secondary|Change From Baseline in the DTS Cluster Sub Score|This instrument consists of 17 items which parallel the DSM criteria for PTSD. Both frequency (0: never; 4: daily or all the time) and intensity (0: none or no problem; 4: extreme, incapacitating) rated using 5-point scale and added to get total score. There were 8 items including guilt, hopelessness, memory impairment, overall response validity, global PTSD severity, global improvement and social and occupational impairment. The DTS cluster includes intrusion (items 1-4, 17 [score 0-40]), A/N (items 5-11 [score 0-56]) and hyperarousal (items 12-16 [score 0-40]) with lower score indicates less symptoms and higher scores means more severity, <20: few symptoms or being asymptomatic, 20-39: mild or subthreshold PTSD, 40-59: threshold and moderate PTSD, 60-79: severe PTSD symptoms and >80: extreme PTSD symptoms. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. Baseline was defined as value on Day 1 (pre-dose).|Baseline (Day 1 pre-dose) and up to Week 12|ITT population. Only those participants available at the specified time points were analyzed.||Score on a scale||Standard Deviation|Mean
805886|NCT01000493|Secondary|Change From Baseline in the Self-rated Davidson Trauma Scale (DTS), by Visit Week|This instrument consists of 17 items which parallel the DSM criteria for PTSD. Both frequency (0: never; 4: daily or all the time) and intensity (0: none or no problem with symptoms; 4: extreme, incapacitating) rated using 5-point scale. There were 8 items assessing associated features (guilt, hopelessness, memory impairment, overall response validity, global PTSD severity, global improvement and social and occupational impairment). The DTS cluster includes intrusion (items 1-4, 17 [score 0-40]), avoidance/numbing (A/N; items 5-11 [score 0-56]) and hyperarousal (items 12-16 [score 0-40]). The total score (0-136) was added, lower score indicates less symptoms and higher scores means more severity, <20: few symptoms or being asymptomatic, 20-39: mild or subthreshold PTSD, 40-59: threshold and moderate PTSD, 60-79: severe PTSD symptoms and > 80: extreme PTSD symptoms. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.|Baseline (Day 1 pre-dose) and up to Week 12|ITT population. Only those participants available at the specified time points were analyzed.||Score on a scale||Standard Deviation|Mean
805887|NCT01000493|Secondary|Change From Baseline in the Short PTSD Rating Review (SPRINT), by Visit Week|The SPRINT consists of 8 items that assess the core symptoms of PTSD, as well as related aspects of somatic malaise, stress vulnerability and functional impairment. Each item was rated on a 5 point scale (0: not at all, 1: a little bit, 2: moderately, 3: quiet a lot and 4: very much), total score 0-32; with higher scores means more severity. Also, it provided the information about how the participant feeling (as a percentage) and symptoms improved since beginning of treatment (rated on a 5 point scale [0: worse, 1: a no change, 2: minimally, 3: much and 4: very much]). The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. Baseline was defined as value on Day 1 (pre-dose).|Baseline (Day 1 pre-dose) and up to Week 12|ITT population. Only those participants available at the specified time points were analyzed.||Score on a scale||Standard Deviation|Mean
805888|NCT01000493|Secondary|Change From Baseline in the CGI-S Score, by Visit Week|The severity of illness items were rated on a 1-7 scale with 0 means not assessed (1: normal, not at all ill, 2: borderline mentally ill, 3: mildly ill, 4: moderately ill, 5: markedly ill, 6: severely ill, 7: among the most extremely ill participants). For the severity of illness item, the clinician indicated his/her assessment of the participant severity of illness considering their total clinical experience with the particular population being studied. It was assessed at Baseline, Week 1, 2, 4, 6, 8, 10 and 12. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. Baseline was defined as value on Day 1 (pre-dose).|Baseline (Day 1 pre-dose) and up to Week 12|ITT population. Only those participants available at the specified time points were analyzed.||Score on a scale||Standard Error|Least Squares Mean
805889|NCT01000493|Secondary|Percentage of Participants Responding, Based on a Clinical Global Impression- Global Improvement (CGI-I) Score of 1 or 2, by Visit Week|The global improvement items were rated on a 1-7 scale with 0 means not assessed (1: very much improved, 2: much improved, 3: minimally improved, 4: no change, 5: minimally worse, 6: much worse, 7: very much worse). For the global improvement item, the clinician indicated their assessment of the participant’s total improvement or worsening compared with that individual's condition at the start of the study (the Baseline visit) whether or not the change was judged to be due to drug treatment. Responder was defined as a participant who had a CGI-I score of 1 or 2 (‘very much improved’ or ‘much improved’). It was assessed at Baseline, Week 1, 2, 4, 6, 8, 10 and 12. Percentage of participants were calculated by total number of responders divided by number of participants assessed multiplied by 100.|Up to Week 12|ITT population. Only those participants available at the specified time points were analyzed.||Percentage of participants|||Number
805928|NCT01006980|Secondary|Pre and Post-dose Plasma Vemurafenib Concentration by Study Day|The pharmacokinetics of vemurafenib were assessed at the beginning of each 21-day cycle using pre-dose and 2-4 hours post-dose sampling.|Plasma samples were collected before the morning dose (troughs) and 2-4 hours after the morning dose at the beginning of each cycle (Days 1, 22, 43, 64, 106, 148 and 190).|"The pharmacokinetic (PK) analysis population included all participants who received vemurafenib and provided valid PK assessments. The PK population at specific time points varied depending on the availability of confirmed dosing and PK assessment times. n indicates the number of participants with available PK data at each time point."||μg/mL||Standard Deviation|Mean
805890|NCT01000493|Secondary|Change From Baseline in the CAPS Hyperarousal Subscale Cluster Score at Weeks 1, 4, 8, and 12|The CAPS was a 30-item clinical interview. Both frequency (0: never; 4: daily or all the time) and intensity (0: none or no problem with symptoms; 4: extreme, incapacitating) ratings were made on a 5-point scale. The CAPS assessed DSM-IV diagnostic criteria for PTSD, including criteria B-D (core symptom clusters of hyperarousal). The re-experiencing subscale cluster score was derived from the CAPS. The possible range is 5 to 25 with lower score indicates less severe symptoms and with a greater score indicating greater PTSD symptom severity. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. Baseline was defined as value on Day 1 (pre-dose).|Baseline (Day 1 pre-dose) and up to Week 12|ITT population. Only those participants available at the specified time points were analyzed.||Score on a scale||Standard Error|Least Squares Mean
805891|NCT01000493|Secondary|Change From Baseline in the CAPS Avoidance/Numbing (A/N) Subscale Cluster Score at Weeks 1, 4, 8, and 12|The CAPS was a 30-item clinical interview. Both frequency (0: never; 4: daily or all the time) and intensity (0: none or no problem with symptoms; 4: extreme, incapacitating) ratings were made on a 5-point scale. The CAPS assessed DSM-IV diagnostic criteria for PTSD, including criteria B-D (core symptom clusters of A/N). The re-experiencing subscale cluster score was derived from the CAPS. The possible range is 7 to 35 with lower score indicates less severe symptoms and with a greater score indicating greater PTSD symptom severity. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. Baseline was defined as value on Day 1 (pre-dose).|Baseline (Day 1 pre-dose) and up to Week 12|ITT population. Only those participants available at the specified time points were analyzed.||Score on a scale||Standard Error|Least Squares Mean
805892|NCT01000493|Secondary|Change From Baseline in the CAPS Re-experiencing Subscale Cluster Score at Weeks 1, 4, 8 and 12|The CAPS was a 30-item clinical interview. Both frequency (0: never; 4: daily or all the time) and intensity (0: none or no problem with symptoms; 4: extreme, incapacitating) ratings were made on a 5-point scale. The CAPS assessed Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) diagnostic criteria for PTSD, including criteria B-D (core symptom clusters of re-experiencing). The re-experiencing subscale cluster score was derived from the CAPS. The possible range was 5 to 25 with lower score indicates less severe symptoms and with a greater score indicating greater PTSD symptom severity. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. Baseline was defined as value on Day 1 (pre-dose).|Baseline (Day 1 pre-dose) and up to Week 12|ITT population. Only those participants available at the specified time points were analyzed.||Score on a scale||Standard Deviation|Mean
805893|NCT01000493|Secondary|Percentage of Participants Remitting, Based on a CAPS Total Score < 20 at Weeks 1, 4, 8, and 12|The CAPS was a 30-item clinical interview. Both frequency (0: never; 4: daily or all the time) and intensity (0: none or no problem with symptoms; 4: extreme, incapacitating) ratings were made on a 5-point scale. The CAPS total severity score was based on the 17 items that assess the frequency and intensity of PTSD symptoms. There were 8 items assessing associated features (guilt, hopelessness, memory impairment, overall response validity, global PTSD severity, global improvement and social and occupational impairment). The total score 0-136, higher scores means more severity, < 20: few symptoms or being asymptomatic, 20-39: mild or subthreshold PTSD, 40-59: threshold and moderate PTSD, 60-79: severe PTSD symptoms and > 80: extreme PTSD symptoms. Remitter defined as a participants who has a CAPS total score <20. Percentage of participants were calculated by total number of responders divided by number of participants assessed multiplied by 100.|Up to Week 12|ITT population. Only those participants available at the specified time points were analyzed. The analysis method was logistic regression adjusted for Baseline CAPS total score. At a visit where there were no remitters, no analysis was performed.||Percentage of participants|||Number
805894|NCT01000493|Secondary|Change From Baseline in the 17-item CAPS Total Severity Score at Weeks 1, 4, and 8|The CAPS was a 30-item clinical interview. Both frequency (0: never; 4: daily or all the time) and intensity (0: none or no problem with symptoms; 4: extreme, incapacitating) ratings were made on a 5-point scale. The CAPS total severity score was based on the 17 items that assess the frequency and intensity of PTSD symptoms. There were 8 items assessing associated features (guilt, hopelessness, memory impairment, overall response validity, global PTSD severity, global improvement and social and occupational impairment). The total score 0-136, higher scores means more severity, < 20: few symptoms or being asymptomatic, 20-39: mild or subthreshold PTSD, 40-59: threshold and moderate PTSD, 60-79: severe PTSD symptoms and > 80: extreme PTSD symptoms. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. Baseline was defined as value on Day 1 (pre-dose).|Baseline (Day 1 pre-dose) and Week 1, 4, 8|ITT population. Only those participants available at the specified time points were analyzed.||Score on a scale||Standard Error|Least Squares Mean
805895|NCT01000493|Secondary|The Time to (Maintained) Clinical Response in Each Participants|The CAPS was a 30-item clinical interview. Both frequency (0: never; 4: daily or all the time) and intensity (0: none or no problem with symptoms; 4: extreme, incapacitating) ratings were made on a 5-point scale. The CAPS total severity score was based on the 17 items that assess the frequency and intensity of PTSD symptoms. There were 8 items assessing associated features (guilt, hopelessness, memory impairment, overall response validity, global PTSD severity, global improvement and social and occupational impairment). The total score 0-136, higher scores means more severity, < 20: few symptoms or being asymptomatic, 20-39: mild or subthreshold PTSD, 40-59: threshold and moderate PTSD, 60-79: severe PTSD symptoms and > 80: extreme PTSD symptoms. The time required to maintain CAPS response has been summarized.|Up to Week 12|ITT Population. Only those participants available at the indicated time points were analyzed.||Days||Inter-Quartile Range|Median
805929|NCT01006980|Secondary|Number of Participants With Adverse Events (AEs)|The intensity of AEs was graded according to the NCI Common Terminology Criteria for Adverse Events v 4.0 (CTCAE) on a five-point scale (Grade 1 to 5: Mild, Moderate, Severe, Life-threatening and Death). A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution, for example is life-threatening, requires hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or requires intervention to prevent one or other of the outcomes listed above.|From randomization (initiated January 2010) until December 30, 2010.|The safety population was defined as all treated participants who had at least one on-study assessment. The safety population was analyzed according to the treatment received.||participants|||Number
805896|NCT01000493|Secondary|Percentage of Participants Responding, Based on More Than Equal to (>=) 30 Percent (%) Reduction From Baseline in CAPS Total Severity Score at Weeks 1, 4, 8 and 12|The CAPS was a 30-item clinical interview. Both frequency (0: never; 4: daily or all the time) and intensity (0: none or no problem with symptoms; 4: extreme, incapacitating) ratings were made on a 5-point scale. The CAPS total severity score was based on the 17 items that assess the frequency and intensity of PTSD symptoms. There were 8 items assessing associated features (guilt, hopelessness, memory impairment, overall response validity, global PTSD severity, global improvement and social and occupational impairment). The total score 0-136, higher scores means more severity, < 20: few symptoms or being asymptomatic, 20-39: mild or subthreshold PTSD, 40-59: threshold and moderate PTSD, 60-79: severe PTSD symptoms and > 80: extreme PTSD symptoms. Percentage of participants were calculated by total number of responders divided by number of participants assessed multiplied by 100.|Baseline (Day 1 pre-dose) and up to Week 12|ITT Population. Only those participants available at the specified time points were analyzed.||Percentage of participants|||Number
805897|NCT01000493|Primary|Change From Baseline in the 17-item Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale (CAPS) Total Severity Score at Week 12|The CAPS was a 30-item clinical interview. Both frequency (0: never; 4: daily or all the time) and intensity (0: none or no problem with symptoms; 4: extreme, incapacitating) ratings were made on a 5-point scale. The CAPS total severity score was based on the 17 items that assess the frequency and intensity of PTSD symptoms. There were 8 items assessing associated features (guilt, hopelessness, memory impairment, overall response validity, global PTSD severity, global improvement and social and occupational impairment). The total score 0-136, higher scores means more severity, < 20: few symptoms or being asymptomatic, 20-39: mild or subthreshold PTSD, 40-59: threshold and moderate PTSD, 60-79: severe PTSD symptoms and > 80: extreme PTSD symptoms. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. Baseline was defined as value on Day 1 (pre-dose).|Baseline (Day 1 pre-dose) and Week 12|ITT population, consisted of all participants who gave informed consent, were randomized, received at least one dose of double blind medication and for whom at least one post-randomization assessment was available. Only those participants available at the indicated time points were analyzed.||Score on scale||Standard Error|Least Squares Mean
805930|NCT01006980|Secondary|Time to Treatment Failure|Treatment failure was defined as a secondary endpoint in the protocol, defined as death, disease progression or premature withdrawal of study treatment. This endpoint was not included in the Statistical analysis plan; therefore no analyses of time to treatment failure were performed.|approximately 3 years||||||
808672|NCT01034631|Primary|Phase I: Maximum Tolerated Dose of BNC105P in Combination With Everolimus.|Phase I|Until disease progression or unacceptable toxicity, up to 24 cycles or 24 months|12 participants completed at least one cycle of combination therapy and were evaluable.||mg/m^2|||Number
805907|NCT01006291|Secondary|Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of nocturnal confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.|Week 0 to Week 26 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator. In SAS, subjects contributed to the evaluation 'as treated'.230 subjects in the IDeg Flex group, 226 in the IDeg OD group and 229 in the IGlar OD group||Episodes/100 years of patient exposure|||Number
805908|NCT01006291|Secondary|Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 26 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator. In SAS, subjects contributed to the evaluation 'as treated'.230 subjects in the IDeg Flex group, 226 in the IDeg OD group and 229 in the IGlar OD group||Episodes/100 years of patient exposure|||Number
805909|NCT01006291|Secondary|Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)|Mean of SMPG after 26 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, before bedtime, at 4 am and before breakfast.|Week 26|The FAS included all randomised subjects and missing data is imputed using last observation carried forward (LOCF). In FAS, subjects contributed to the evaluation 'as randomised'. For 28 subjects all 9-point SMPG values were missing.||mmol/L||Standard Deviation|Mean
805910|NCT01006291|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Change from baseline in HbA1c after 26 weeks of treatment|Week 0, Week 26|The Full analysis set (FAS) included all randomised subjects and missing data is imputed using last observation carried forward (LOCF). In FAS, subjects contributed to the evaluation 'as randomised'.||percentage of glycosylated haemoglobin||Standard Deviation|Mean
805946|NCT01007123|Primary|Change From Baseline in Frequency of Spontaneous Bowel Movements|Primary ep W 1|Baseline, weekly, up to 8 weeks|ITT population||Number of SBMs||Standard Error|Least Squares Mean
805911|NCT01006356|Secondary|European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties) which are based on 4-point scale (1=Not at all to 4=Very much); and global health status and quality of life scale based on 7-point scale (1=very poor to 7=Excellent). All scales and items are averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptomatology or problems.|Day 1 and Day 15|The ITT analysis population included all the participants who received at least 1 dose of study drug and had available data in the dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Day 8. LOCF was used. Here 'n' signifies participants evaluable for this outcome measure at given time point.||Units on a Scale||Standard Deviation|Mean
805912|NCT01006356|Secondary|Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score|Investigators evaluated the overall improvement of the participant’s condition using CGI scale. The CGI-I is a 7-point scale that requires the clinician to assess how much the participant’s patient’s illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=greatly improved; 2=somewhat improved; 3=slightly improved; 4=no change; 5=slightly aggravated ; 6=somewhat aggravated; 7=greatly aggarvated.|Day 15|The ITT analysis population included all the participants who received at least 1 dose of study drug and had available data in the dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Day 8. LOCF was used. Here 'N'=participants evaluated for this outcome measure.||Participants|||Number
805913|NCT01006356|Secondary|Participant’s Preferences Along With Reasons|The number of participants who preferred oral long-acting narcotic analgesics or previously administered oral opioid analgesic were reported along with detailed and specific reasons such as consistent analgesic effect during administration, sleep undisturbed by pain, reduced intake of medication frequency, reduce intake of immediate-release opioid analgesic for breakthrough pain treatment, other and no response, for their preferences. Same participant may have multiple reason for their preference.|Day 15|The ITT analysis population included all participants who received at least 1 dose of study drug and had available data in dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Day 8. LOCF was used. Here 'N'=participants evaluated for this outcome measure and 'n'=participants who took hydromorphone OROS/oral opioid.||Participants|||Number
805914|NCT01006356|Secondary|Global Assessment of Overall Efficacy of Study Drug by Participant|Participants evaluated overall efficacy of study drug and the responses were categorized as: 'ineffective response', 'average response', ‘effective response', ‘very effectiveresponse', and ‘highly effective response'.|Day 15|"The ITT analysis population included all the participants who received at least 1 dose of study drug and had available data in the dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Day 8. LOCF was used. Here N signifies participants evaluated for this outcome measure."||Participants|||Number
805915|NCT01006356|Secondary|Global Assessment of Overall Efficacy of Study Drug by Investigator|Investigator evaluated overall efficacy of study drug and the responses were categorized as: 'ineffective response', 'average response', ‘effective response', ‘very effectiveresponse', and ‘highly effective response'.|Day 15|"The ITT analysis population included all the participants who received at least 1 dose of study drug and had available data in the dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Day 8. LOCF was used. Here N signifies participants evaluated for this outcome measure."||Participants|||Number
805916|NCT01006356|Secondary|Pain Intensity Score|Average Pain intensity score experienced by Participant over the last 24 hours of Day 3 and Day 13 was recorded. Pain intensity was measured using numerical rating scale (NRS) ranging from 0=no pain to 10=most severe pain.|Day 3 and Day 13|The ITT analysis population included all the participants who received at least 1 dose of study drug and had available data in the dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Day 8. LOCF was used. Here 'n' signifies participants evaluable for this outcome measure at given time point.||Units on a scale||Standard Deviation|Mean
805917|NCT01006356|Secondary|Change From Baseline in Korean - Brief Pain Inventory (K-BPI) Score at Day 15|K-BPI is an inventory designed to measure the degree of pain severity and the impact of pain in performing daily routines. K-BPI comprises of total 9 items in total, and the ninth item consisting of 7 sub-items is a question asking the degree of disturbance due to pain. The score ranges from 0 to 10, where 0=no pain, 1 to 4=mild pain, 5 to 6=moderate pain and 7 to 10=severe pain.|Baseline and Day 15|The ITT analysis population included all the participants who received at least 1 dose of study drug and had available data in the dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Day 8. LOCF was used.||Units on a scale||Standard Deviation|Mean
805918|NCT01006356|Secondary|Frequency of Experiencing Breakthrough Pain|Frequency of experiencing 3 types of breakthrough pain: Idiopathic pain (pain of unknown cause), incidental pain (pain that arises as a result of activity, such as movement of an arthritic joint, stretching a wound) and end-of-dose failure pain was reported.|Day 1 and Day 15|The ITT analysis population included all the as participants who received at least 1 dose of study drug and had available data in the dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Day 8. LOCF was used.||Pain episodes per day||Standard Deviation|Mean
805919|NCT01006356|Primary|Percentage of Participants With Dosing Frequency of Analgesics for Treating Breakthrough Pain|Percentage of participants with decrease in dosing frequency by 33 percent or more in breakthrough pain (acute pain that comes on rapidly despite the use of pain medication) was determined at final visit (Day 15) compared to Baseline (Day 1 - when the administration of study drug was started).|Day 15|The intent-to-treat (ITT) analysis population included all the participants who received at least 1 dose of study drug and had available data in the dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Day 8. Last observation carried forward (LOCF) was used.||Percentage of Participants|||Number
805920|NCT01006889|Secondary|Change in Anthropometric Variables (BMI).||6 months|The number of participants included were the ones that completed the study.||Kg/m2||Standard Deviation|Mean
805921|NCT01006889|Secondary|Lipid Profiles, Lipoprotein Analysis by NMR (LipoScience).|Change in lipid levels vs. pretreatment.|6 months|Number of patients completing.||mg/dl||Standard Deviation|Mean
817122|NCT01119768|Secondary|Percentage of Patients Satisfaction|Satisfied - satisfaction score of 1-4 while very satisfied - satisfaction score of 1-2.|24 weeks after end of treatment|MITT||percentage of participants|||Number
805931|NCT01006980|Secondary|Time to Confirmed Response|Time to response was defined as the time from randomization to confirmed response (complete response or partial response).|From randomization (initiated January 2010) until December 30, 2010.|The analysis population included all participants randomized by September 22, 2010 and with a best overall confirmed response of complete response or partial response.||months||Full Range|Median
805932|NCT01006980|Secondary|Duration of Response|Duration of response was defined as the time between the date of the earliest qualifying response and the date of disease progression or death due to any cause. Duration of response was calculated only for participants who had a best overall response of Complete Response or Partial Response and was estimated using the Kaplan–Meier method.|From randomization (initiated in January 2010) until December 30, 2010.|The analysis population included all participants randomized by September 22, 2010 and with a best overall confirmed response of complete response or partial response.||months||95% Confidence Interval|Median
805933|NCT01006980|Secondary|Participants With a Best Overall Response (BOR) of Complete Response or Partial Response|BOR was defined as a complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. Participants who never received study treatment and treated participants without any post-baseline tumor assessments were considered as non-responders. CR: Disappearance of all target lesions, all non-target lesions and no new lesion. Any pathological lymph nodes must have had reduction in the short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion and no new lesion.|From randomization (initiated January 2010) until December 30, 2010|The analysis population consisted of all ITT participants randomized by September 22, 2010 (at least 14 weeks prior to the clinical cutoff date of December 30, 2010). The 14-week interval was chosen as it was the minimum time needed to observe a confirmed overall response according to protocol-specified schedule for the first two tumor assessments.||participants|||Number
805934|NCT01006980|Primary|Progression-free Survival|A progression-free survival (PFS) event was defined as disease progression or death due to any cause. Tumor response (progression) was assessed according to the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 criteria using computed tomography (CT) scans or magnetic resonance imaging (MRI).|From randomization (initiated January 2010) to December 30 2010.|The analysis population for PFS consisted of all ITT participants randomized by October 27, 2010 (at least 9 weeks prior to the clinical cutoff date of December 30, 2010). The 9-week interval was chosen to allow time for participants to have had their first scheduled post baseline tumor assessment CT scan.||participants|||Number
805935|NCT01006980|Primary|Overall Survival|An Overall survival event was defined as death due to any cause. The number of participants with overall survival events is reported.|From randomization (initiated January 2010) to December 30 2010. Median follow-up time in the vemurafenib group was 3.75 months (range 0.3 to 10.8) and in the dacarbazine group was 2.33 months (range <0.1 to 10.3).|The intent-to-treat (ITT) population was defined as all randomized participants, whether or not study treatment was received. The ITT population was analyzed according to the treatment assigned at randomization. Overall survival was assessed on participants randomized at least 15 days prior to the clinical cutoff date of December 30, 2010.||participants|||Number
805936|NCT01007110|Secondary|Cardiac Conduction Time||Change from Baseline to 2 Months Post-natal|||milliseconds||Standard Deviation|Mean
805937|NCT01007110|Secondary|Cord Blood Phospholipids DHA|Newborn red blood cell phospholipids collected at birth.|Birth|||weight percent total fatty acids||Inter-Quartile Range|Median
805938|NCT01007110|Secondary|Maternal Red Blood Cell (RBC) Phospholipids at Delivery|Maternal red blood cell phospholipid collected at delivery. These results were compared to baseline red blood cell phospholipid that was collected at study enrollment. A weighed standard fatty acid mixture (Supelco 37 component fatty acid methyl ester mix,Sigma Aldrich) was employed to correct final DHA weight percent of total fatty acids (wt%TFA).|Time of delivery, 36 weeks to term|||weight percent Total Fatty Acids||Inter-Quartile Range|Median
805939|NCT01007110|Secondary|Neonatal Behavioral Assessment Scale (NBAS) Scores|"The Neonatal Behavioral Assessment Scale (NBAS) measure 6 areas.
For behavioral items a higher score corresponds to more desirable outcomes:
Habituation: Sum of scores across 3 items, scored on a scale of 1-9. Range: 3-27.
Orientation: Sum of scores across 7 items, scored on a scale of 1-9. Range: 7 – 63.
Motor: Sum of scores across 5 items; 3 scored on a scale of 1-9, 1 scored on a scale of 1-6, and 1 scored on a scale of 1-5. Range: 5-38.
Range of State: Sum of scores across 4 items; 2 scored on a scale of 1-6 and 2 scored on a scale of 1-5. Range: 4-22.
Regulation of State: Sum of scores across 4 items, scored on a scale of 1-9. Range: is 4-36.
Autonomic Stability: Sum of scores across 3 items; 1 scored on a scale of 1-9, 1 on a scale of 1-8, and 1 on a scale of 1-6. Range: 3-23.
Reflexes: Sum across the 18 items, scored on a scale of 0-3. Range: 0 to 54. The supplementary items are each scored on a scale of 1-9 and do not combine to form a composite."|within 2 weeks of delivery|||units on a scale||Standard Deviation|Mean
805940|NCT01007110|Primary|Heart Rate|Mean fetal heart rate calculated from the magnetocardiogram recorded at 24, 32 and 36 weeks gestational age.|24, 32 and 36 weeks gestational age|"Placebo: 19 subjects @ 24 wks GA, 25 subjects @ 32 wks GA, 24 subjects @ 36 wks GA
DHA: 21 subjects @ 24 wks GA, 23 subjects @ 32 wks GA, 22 subjects @ 36 wks GA"||Beats per minute||Standard Deviation|Mean
805941|NCT01007123|Secondary|Straining Change From Baseline|Daily assessment of straining. Min value: 1. Max value: 5. Higher value indicates more straining.|Baseline and during 8 weeks of treatment|ITT population||units on a scale (1-5)||Standard Error|Least Squares Mean
805942|NCT01007123|Secondary|LDL/HDL Ratio|Ratio of plasma LDL cholesterol and HDL cholesterol Difference from baseline, placebo-adjusted|Baseline and 8 weeks of treatment|ITT population||Ratio||Standard Error|Least Squares Mean
805943|NCT01007123|Secondary|Stool Consistency Change From Baseline|Bristol Stool Form Scale. Min value:1. Max value: 7. Higher value indicates more liquid shape than normal, lower indicates constipated state.|Baseline, weekly and up to 8 weeks|ITT population||units on a scale (1-7)||Standard Deviation|Least Squares Mean
805944|NCT01007123|Secondary|Time to First Bowel Movement||First week|ITT population||hours||95% Confidence Interval|Median
805945|NCT01007123|Secondary|Responder Analyses for Complete Spontaneous Bowel Movements (CSBMs)|"A CSBM responder is defined as per FDA draft guidance for IBS-C:
An increase of one or more of CSBMs per week over baseline for at least 4 out of the 8 weeks of treatment"|Baseline, weekly and up to 8 weeks|ITT population||participants|||Number
817123|NCT01119768|Secondary|Number of Patients With Unscheduled Hospital Visit(s)||from baseline to week 24 after end of treatment|MITT||participants|||Number
805947|NCT01007149|Primary|Change From Baseline in the Expression of FcεRI Receptors of Dendritic Cells|Venous blood samples were collected at screening and at Week 16. Flow cytometry analysis determined the FcεRI receptors expression of dendritic cells (mean fluorescence intensity (MFI)). Relative change in mean fluorescence intensity at the end of study was expressed as a percentage of baseline value.|Baseline and 16 weeks|Intent to Treat FcεRI analyzable population - all randomized patients who received at least one dose of study drug and had at least one post-baseline efficacy assessment, and who had a valid baseline and post-treatment measurement of FcεRI||Percent change in MFI||Standard Deviation|Mean
805948|NCT01007149|Secondary|Number of Patients With at Least One Asthma-related Event Over 16 Weeks|Asthma-related events were: unscheduled medical visits, emergency room visits and hospitalizations. Details of exacerbations requiring oral or IV corticosteroids were recorded at each visit.|16 weeks|Intent to Treat Population - all randomized patients who received at least one dose of study drug and had at least one post-baseline efficacy assessment||Participants|||Number
805949|NCT01007149|Secondary|Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to 16 Weeks|Spirometry was conducted according to internationally accepted standards. At least three maneuvers were performed at each sampling timepoint. The FEV1 recorded was taken from the maneuver obtained from the single best test curve. The best test curve was defined as the spirogram that gave the largest FEV1.|Baseline and 16 weeks|Intent to Treat Population - all randomized patients who received at least one dose of study drug and had at least one post-baseline efficacy assessment||Liters||Standard Deviation|Mean
805950|NCT01007149|Secondary|Physician and Patient Global Evaluation of Treatment Effectiveness|The GETE is an assessment of asthma symptoms controlled in response to asthma treatment. The evaluation was performed independently by both investigator and patient using the same 5 point scale. The scale points are: excellent, good, moderate, poor and worsening. A good or excellent response is suggested as a means of defining a patient who has responded to treatment.|16 weeks|Intent to Treat Population - all randomized patients who received at least one dose of study drug and had at least one post-baseline efficacy assessment||Participants|||Number
805951|NCT01007149|Secondary|Change From Baseline in Nasal Symptom Global Score and Individual Components|Nasal symptom score calculated from six scales assessing the nasal symptom severity (sneezing, runny nose, congestion, itchy nose, postnasal drip and nasal symptoms overall). These six scores were rated on a scale from 1 to 7, with 7 being the worst rating. Absolute changes in these six scores were expressed versus baseline values. A negative change indicates improvement. The range of the global score was from 1 to 7, since this is the mean value of all the subscores.|Baseline and 16 weeks|Intent to Treat Population - all randomized patients who received at least one dose of study drug and had at least one post-baseline efficacy assessment||Score units||Standard Deviation|Mean
805952|NCT01007149|Secondary|Change From Baseline in Score of the Shortened Version of the Asthma Control Questionnaire (Symptoms Plus Short-acting β2-agonist)|The shortened version of the asthma control questionnaire (symptoms plus β2-agonist) consists of 6 subscores (nighttime waking, symptoms on waking, activity limitation, shortness of breath, wheeze and rescue short-acting β2-agonist use) between 0 and 6 (0 = no impairment; 6 = maximum impairment) and a total score between 0 and 6 (subscores mean value). Absolute change in total score and subscores count was expressed versus baseline value. A decrease in score indicates improvement.|Baseline and 16 weeks|Intent to Treat Population - all randomized patients who received at least one dose of study drug and had at least one post-baseline efficacy assessment||Score units||Standard Deviation|Mean
805953|NCT01007149|Secondary|Change From Baseline in Induced Sputum Eosinophil Count|The induced sputum eosinophil count was measured in a subset of patients in selected centers. Sputum samples were collected at screening and Week 16. Sputum eosinophil count was expressed as a percentage of total nonsquamous cells. Absolute change in sputum eosinophil count was expressed versus baseline value.|Baseline and 16 weeks|Intent to Treat population - all randomized patients who received at least one dose of study drug and had at least one post-baseline efficacy assessment. Only patients with measurements at both baseline and week 16 were included in this analysis.||Percentage of total nonsquamous cells||Standard Deviation|Mean
805954|NCT01007149|Secondary|Change in Fractional Exhaled Nitric Oxide (FeNO)|FeNO was measured at baseline, and after 4, 8, 12 and 16 weeks of treatment. Absolute change in FeNO was expressed at each time point versus baseline value.|Baseline and 4, 8, 12 and 16 weeks|Intent to Treat population - all randomized patients who received at least one dose of study drug and had at least one post-baseline efficacy assessment. During different time points, participants with observations at that time point were included in the analysis.||parts per billion (ppb)||Standard Deviation|Mean
805955|NCT01007149|Primary|Change From Baseline in the Expression of FcεRI Receptors of Blood Basophils|Venous blood samples were collected at screening and at Week 16. Flow cytometry analysis determined the FcεRI receptors expression of blood basophils (mean fluorescence intensity(MFI)). Relative change in mean fluorescence intensity at the end of study was expressed as a percentage of baseline value.|Baseline and 16 weeks|Intent to Treat FcεRI analyzable population - all randomized patients who received at least one dose of study drug and had at least one post-baseline efficacy assessment, and who had a valid baseline and post-treatment measurement of FcεRI||Percent change in MFI||Standard Deviation|Mean
805956|NCT01007253|Secondary|Total Number of Eosinophils|The percentage of eosinophils among white blood cells was determined under light microscopy at 1000x magnification, and the total number of eosinophils in each lavage was then calculated. The specimens that had no eosinophils identified on differential counting despite adequate cells on the smear were assigned a number that corresponded to the lowest number of eosinophils on a slide where the number could be counted. That number was 33 total eosinophils.|50 minutes [duration of 3 nasal challenges and 2 washout periods]|One subject was removed from the study due to upper respiratory tract infection, reducing the number of evaluable subjects from 21 to 20.||eosinophils||Full Range|Median
806005|NCT01007942|Secondary|Vinorelbine Blood Concentrations by Leading Dose and Time Point|Pre-infusion (Cmin) and end of infusion (C2h) vinorelbine PK blood samples were collected at Cycle 2 Day 1. Only valid vinorelbine PK blood samples collected at steady state were used in the analyses.|Cycle 2, Day 1|The Safety Set consisted of all patients who received at least one dose of the study treatment and who had at least one valid post-baseline safety assessment.||ng/ml||Standard Deviation|Mean
808673|NCT01034657|Secondary|Time to Cause-specific Death - Overall Period|Time to cause-specific death was defined as the time from start of treatment to death related to MDS.|52 weeks|Time to cause-specific death could not be evaluated because there was no cause-specific death.|||||
805957|NCT01007253|Secondary|Change in Tryptase Level (Across Nasal Challenges)|"Tryptase is an enzyme that is released, along with histamine and other chemicals, from mast cells when they are activated, often as part of an allergic immune response. Tryptase in nasal lavages was measured using the ImmunoCap tryptase assay, by Phadia (Uppsala, Sweden). The limit of detection of the assay is 1.0 ng/mL, and levels below this value were arbitrarily assigned a value of 0.5 ng/mL.
For each patient, tryptase levels recorded after the diluent challenge were subtracted from tryptase levels recorded after each of the three nasal challenges. These differences were added across challenges, yielding the total change in tryptase level reported in this outcome for each patient."|50 minutes [duration of 3 nasal challenges and 2 washout periods]|One subject was removed from the study due to upper respiratory tract infection, reducing the number of evaluable subjects from 21 to 20.||ng/mL||Full Range|Median
805958|NCT01007253|Secondary|Change in Histamine Level (Across Nasal Challenges)|"Histamines are simple chemical substances produced by immune system cells when reacting to an antigen in response to foreign invaders like germs and bacteria.
Histamine in nasal lavages was measured using a histamine enzyme immunoassay kit market by SPI-BIo, Bertin Pharma (Montigny le Bretonneux, France). The limit of detection of the assay is 0.4 nM, and levels below the detection limit were arbitrarily assigned a value of 0.2 nM. Samples that yielded values above the upper detection limit of the assay were diluted and reassayed.
For each patient, histamine levels recorded after the diluent challenge were subtracted from histamine levels recorded after each of the three nasal challenges. These differences were added across challenges, yielding the total change in histamine level reported in this outcome for each patient."|50 minutes [duration of 3 nasal challenges and 2 washout periods]|One subject was removed from the study due to upper respiratory tract infection, reducing the number of evaluable subjects from 21 to 20.||nM||Full Range|Median
805959|NCT01007253|Secondary|Total Number of Sneezes||50 minutes [duration of 3 nasal challenges and 2 washout periods]|One subject was removed from the study due to upper respiratory tract infection, reducing the number of evaluable subjects from 21 to 20.||sneezes||Full Range|Median
805960|NCT01007253|Secondary|Total Nasal Symptoms Score Difference|After treatment, each participant was subjected to a diluent (control) challenge in one nostril and was asked to rate nasal symptoms (congestion, rhinorrhea, and itchy nose/throat) according to the following scale: 0=none, 1=mild, 2=moderate, 3=severe. The participant was then exposed to 3 doses of an antigen challenge and was asked to similarly rate severity of nasal symptoms after each dose. Diluent challenge scores were subtracted from the scores recorded after each dose. This process was repeated in the other nostril. The outcome is the total number of score differences (i.e. score after each dose subtracted by diluent challenge score) summed across doses, symptoms (congestion, rhinorrhea, and itchy nose/throat), and nostrils (left and right). Thus, each participant's total score is an integer value ranging from -36 to 36.|50 minutes [duration of 3 nasal challenges and 2 washout periods]|One subject was removed from the study due to upper respiratory tract infection, reducing the number of evaluable subjects from 21 to 20.||units on a scale||Full Range|Median
805961|NCT01007253|Primary|Total Eye Symptoms Score Difference|After treatment, each participant was subjected to a diluent (control) challenge in one eye and was asked to rate 2 eye symptoms (watery and itchy) according to the following scale: 0=none, 1=mild, 2=moderate, 3=severe. The participant was then exposed to 3 doses of an antigen challenge and was asked to similarly rate severity of watery and itchy eye symptoms after each dose. Diluent challenge scores were subtracted from the scores recorded after each dose. This process was repeated in the other eye. The outcome is the total of the score differences (i.e. score after each dose subtracted by diluent challenge score) summed across doses, symptoms (watery and itchy), and eyes (left and right). Thus, each participant's total score is an integer value ranging from -36 to 36.|50 minutes [duration of 3 nasal challenges and 2 washout periods]|One subject was removed from the study due to upper respiratory tract infection, reducing the number of evaluable subjects from 21 to 20.||units on a scale||Full Range|Median
805962|NCT01007396|Secondary|Negative Conversion Rate in Follow-up QuantiFERON-TB Gold In-Tube Test (QFT-IT Test) After Treatment of Latent Tuberculosis Infection (LTBI)|"The percentage of participants with negative conversion in follow-up QFT-IT test after LTBI treatment, out of those who had QFT-IT test conversion after one year of employment and agreed to undergo treatment for LTBI according to our recommendation
Participants with QFT-IT test conversion were recommended for LTBI therapy using 3 months of daily isoniazid and rifampicin, which was the regular treatment for LTBI in our institution.
The QFT-IT test was repeated after LTBI therapy. Negative conversion was defined as baseline IFN-r ≥ 0.35 and follow-up IFN-r < 0.35 IU/ml."|3 months after LTBI treatment|Thirteen participants agreed to undergo treatment for latent tuberculosis infection and completed 3 months therapy.||Percentage of participants|||Number
805963|NCT01007396|Primary|Annual Incidence of Tuberculosis Infection Among Newly Employed Doctors and Nurses in Korea|The participants performed QuaniFERON-TB Gold In-Tube test (QFT-IT test). Annual infection of tuberculosis infection was evaluated with the conversion of QFT-IT test through annual check up of QFT-IT test. The definitions for QFT-IT test conversion was based on the CDC definition (Baseline IFN-r < 0.35 IU/ml and follow-up IFN-r ≥ 0.35 IU/ml).|QFT-IT test was performed at enrollment and repeated at point of one year after enrollment. So, the length of timw which from the start of the first test of very first participant to the end of second test of very last participant is 2 years.|Of the 322 healthcare workers (HCWs), 275 (85%) underwent repeat QuantiFERON-TB Gold In-Tube test (QFT-IT test) after 1 year of employment; the 47 participants who had resigned were excluded. Two participants with indeterminate results on the baseline QFT-IT test were excluded from the analysis.||number of new cases per 1000 person/year|||Number
805964|NCT01007435|Secondary|Change From Baseline in Short Form 36 (SF-36) Physical Component Summary (PCS) Scores at Weeks 24 and 52|The SF-36 Health Survey (Version 2) is a standardized questionnaire consisting of 36 questions that measures patient-reported symptoms on 8 dimensions; it is used to assess health-related quality of life (HRQoL). The Physical Component Summary (PCS) score summarizes the subscales Physical Functioning, Role-Physical, Bodily Pain, and General Health. The Mental Component Summary (MCS) score summarizes the subscales Vitality, Social Functioning, Role-Emotional, and Mental Health. Each score was scaled from 0 to 100. A positive change score indicates better HRQoL.|Baseline to Weeks 24 and 52|Intent-to-treat population: All randomized participants who received at least 1 tocilizumab/placebo infusion.||Units on a scale||Standard Deviation|Mean
808674|NCT01034657|Secondary|Disease-free Survival (DFS) - Overall Period|DFS was defined as the time from start of treatment to the time to relapse.|52 weeks|DFS could not be evaluated because there was no disease-free period.|||||
805965|NCT01007435|Secondary|Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Weeks 24 and 52|The Stanford HAQ-DI is a patient completed questionnaire specific for rheumatoid arthritis. The HAQ-DI assesses how well the patient is able to perform 8 activities: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. The patient answers 20 questions with 1 of 4 responses with the past week as the time frame: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The highest score for any question in a category determines the category score. The total score ranges from 0 (no disability) to 3 (completely disabled). A negative change score indicates improvement.|Baseline to Weeks 24 and 52|Intent-to-treat population: All randomized participants who received at least 1 tocilizumab/placebo infusion.||Units on a scale||Standard Deviation|Mean
805966|NCT01007435|Secondary|Percentage of Participants With a Major Clinical Response at Week 52|A major clinical response is defined as an ACR70 response that is maintained for 6 consecutive months (24 weeks) for any 24-week period between Week 2 and Week 52.|Baseline to Week 52|Intent-to-treat population: All randomized participants who received at least 1 tocilizumab/placebo infusion.||Percentage of participants|||Number
805967|NCT01007435|Secondary|Change From Baseline in Sharp Joint Space Narrowing Score at Week 52||Baseline to Week 52|Intent-to-treat population: All randomized participants who received at least 1 tocilizumab/placebo infusion.||Units on a scale||Standard Deviation|Mean
805968|NCT01007435|Secondary|Change From Baseline in Modified Sharp Erosion Score at Week 52||Baseline to Week 52|Intent-to-treat population: All randomized participants who received at least 1 tocilizumab/placebo infusion.||Units on a scale||Standard Deviation|Mean
805969|NCT01007435|Secondary|Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52|The mTSS is a measure of joint damage and includes measures of joint erosion (JE) and joint space narrowing (JSN). The JE score, using the van der Heijde modification, measures erosion severity in 32 hand joints and 12 foot joints. Each hand joint is scored from 0 to 5 and each foot joint is scored from 0 to 10; the total score ranges from 0 to 280. Each joint is scored according to the surface area involved. A score of 10 indicates extensive loss of bone from more than one-half of the articulating bone; a score of 0 indicates no erosion. The JSN score measures the severity of JSN in 30 hand joints (15 per hand) and 12 foot joints (6 per foot). Each joint, including subluxation, is scored from 0 to 4; the total score ranges from 0 to 168. A higher score indicates more joint space narrowing. The mTSS ranges from 0 to 448 (280+168). A higher mTSS score indicates greater damage. A negative change score indicates improvement.|Baseline to Week 52|Intent-to-treat population: All randomized participants who received at least 1 tocilizumab/placebo infusion.||Units on a scale||Standard Deviation|Mean
805970|NCT01007435|Secondary|Percentage of Patients With an Improvement ≥ 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20/50/70) From Baseline to Weeks 24 and 52|Improvement must be seen in tender (68) and swollen (66) joint counts. Joints were assessed and classified as swollen/not swollen and tender/not tender by pressure and joint manipulation. Improvement must also be seen in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, the extreme left end of the line “no disease activity” [symptom-free and no arthritis symptoms] and the extreme right end “maximum disease activity”; patient assessment of pain in previous the 24 hours on a VAS (extreme left end of the line “no pain” and the extreme right end “unbearable pain”); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and C-reactive protein (CRP), or erythrocyte sedimentation rate if CRP was missing.|Baseline to Weeks 24 and 52|Intent-to-treat population: All randomized participants who received at least 1 tocilizumab/placebo infusion.||Percentage of participants|||Number
805971|NCT01007435|Secondary|Percentage of Participants With a Disease Activity Score 28 (DAS28) Remission Response at Week 52||Week 52|Intent-to-treat population: All randomized participants who received at least 1 tocilizumab/placebo infusion.||Percentage of participants|||Number
805972|NCT01007435|Primary|Percentage of Participants With a Disease Activity Score 28 (DAS28) Remission Response at Week 24|A participant has a DAS28 remission response if their DAS28 < 2.6. The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient’s global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.|Week 24|Intent-to-treat population: All randomized participants who received at least 1 tocilizumab/placebo infusion.||Percentage of participants|||Number
805973|NCT01007552|Secondary|Collect Samples at Baseline, Day 8 and Day 43 for Future Biomarker Studies and Development of Profiles of Responders to Anti-VEGF Therapy (Optional)|This was a tissue banking end point of sample collection for future studies. No analysis was completed.|Baseline, day 8 and day 43|No patients were analyzed and no data were collected for this Outcome Measure. This was an optional aim and the research team decided to opted out of analyzing.|||||
805974|NCT01007552|Secondary|Circulating Tumor Cells (CTC) Will be Assessed at Baseline, Day 22 and Day 43|Mean number of CTCs in 7.5 ml of whole blood|baseline, day 22 and day 43|All treated and eligible patients||cells||Standard Deviation|Mean
805975|NCT01007552|Secondary|Assess Overall Survival (OS)||From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years|All treated and eligible patients||months||95% Confidence Interval|Mean
806006|NCT01007942|Secondary|Everolimus Blood Concentrations by Leading Dose and Time Point|Pre-dose (Cmin) and 2 hours post-dose (C2h) everolimus PK blood samples were collected at Cycle 2 Day 1. Only valid everolimus PK blood samples collected at steady state were used in the analyses.|Cycle 2, Day 1|The Safety Set consisted of all patients who received at least one dose of the study treatment and who had at least one valid post-baseline safety assessment.||ng/ml||Standard Deviation|Mean
808675|NCT01034657|Secondary|Progression-free Survival (PFS) - Overall Period|PFS was defined as the time from start of treatment to disease progression or death from MDS.|52 weeks|PFS could not be evaluated because there was no progression.|||||
805976|NCT01007552|Secondary|Assess the Change in the Quality of Life Among Patients Using the FACT-Hep (Version 4) for Hepatobiliary Cancers.|"We utilized the FACT-HEP TOTAL SCORE (version 4) quality-of-life scale, which is a 45 item scale ranging from 96-178. Higher scores of the reflect better quality of life.
For a Detailed description see:
Nancy Heffernan, David Cella, Kimberly Webster, Linda Odom, Mary Martone, Steven Passik, Marilyn Bookbinder, Yuman Fong, William Jarnagin, and Leslie Blumgart: Measuring Health-Related Quality of Life in Patients With Hepatobiliary Cancers: The Functional Assessment of Cancer Therapy–Hepatobiliary Questionnaire. Journal of Clinical Oncology, Vol 20, No 9 (May 1), 2002: pp 2229-2239.
No subscales were analyzed."|Baseline, Day 22 and Day 43|All treated and eligible patients. Some measures were not complete for leading to missing values.||units on a scale||Standard Deviation|Mean
805977|NCT01007552|Secondary|Assess the Toxicity of the Regimen.|Number of patients with Serious Adverse Events. Please refer to the adverse event reporting for more detail.|up to 5 years|All treated and eligible patients||participants|||Number
805978|NCT01007552|Secondary|Estimate the Proportion of Patients With Clinical Response|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years|All treated and eligible patients||percentage of participants||95% Confidence Interval|Number
805979|NCT01007552|Primary|The Primary Objective of This Study is to Assess Progression Free Survival (PFS) With Proposed Therapy for Patients With Locally Advanced or Metastatic Gallbladder and Biliary Cancers.|"Progression will be evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST 1.0). Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria. Note: Lesions are either measurable or non-measurable using the criteria provided below. The term evaluable in reference to measurability will not be used because it does not provide additional meaning or accuracy."|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years|All treated and eligible patients||months||95% Confidence Interval|Median
805980|NCT01007643|Secondary|Change in Vastus Medialis Oblique Muscle Strength||3 months||||||
805981|NCT01007643|Secondary|Change in Quadriceps Flexibility||3 months||||||
805982|NCT01007643|Secondary|Change in Hamstring Flexibility||3 months||||||
805983|NCT01007643|Secondary|Changes in Patellofemoral Symptoms||3 months||||||
805984|NCT01007643|Primary|Percentage of Exercise Days Completed.|Calculated for the 12 week period as daily exercise completion rate as percentage|3 months|Per Protocol||percentage of days completed||Full Range|Mean
805985|NCT01007656|Primary|R-glutamyl Transpeptidase (r-GT)||90 days|||U/L||Standard Deviation|Mean
805986|NCT01007656|Primary|Glucose||90 days|||mg/dL||Standard Deviation|Mean
805987|NCT01007656|Primary|Globulin||90 days|||g/dL||Standard Deviation|Mean
805988|NCT01007656|Primary|Creatinine||90 days|||mg/dL||Standard Deviation|Mean
805989|NCT01007656|Primary|Cholesterol||90 days|||mg/dL||Standard Deviation|Mean
805990|NCT01007656|Primary|BUN||90 days|||mg/dL||Standard Deviation|Mean
805991|NCT01007656|Primary|Total Bilirubin|Bilirubin is released into the blood when red blood cells break down. The liver uses bilirubin to make bile. Normally there is only a small amount of bilirubin in the blood. High levels may be caused by liver or blood problems.|90 days|||mg/dL||Standard Deviation|Mean
805992|NCT01007656|Primary|Direct Bilirubin|Direct bilirubin is referred to as conjugated bilirubin, which is water-soluble. It's taken up by the liver cells and conjugated to form the water-soluble bilirubin diglucuronide. It's used to diagnose and/or monitor liver diseases, such as cirrhosis, hepatitis or gallstones. If direct bilirubin is elevated more than unconjugated bilirubin, there's typically a problem associated with decreased elimination of bilirubin by the liver cells.|90 days|||mg/dL||Standard Deviation|Mean
805993|NCT01007656|Primary|Alkaline Phosphatase||90 days|||U/L||Standard Deviation|Mean
805994|NCT01007656|Primary|Albumin||90 days|||g/dL||Standard Deviation|Mean
805995|NCT01007656|Primary|Uric Acid||90 days|||mg/dL||Standard Deviation|Mean
805996|NCT01007656|Primary|Total Protein|The total protein test measures the total amount of two classes of proteins in the blood, albumin and globulin.|90 days|||g/dL||Standard Deviation|Mean
805997|NCT01007656|Primary|Triglycerides (TG)||90 days|||mg/dL||Standard Deviation|Mean
805998|NCT01007656|Primary|Serum Glutamic Pyruvate Transaminase (ALT/SGPT)||90 days|||U/L||Standard Deviation|Mean
805999|NCT01007656|Primary|Serum Glutamic Oxaloacetic Transaminase (AST/SGOT)||90 days|||U/L||Standard Deviation|Mean
806000|NCT01007812|Primary|Overall Vision|Overall vision, as interpreted by the subject and reported by the subject on a questionnaire as a single, retrospective evaluation of one week’s wear time. Overall vision was measured on a 10-point scale, with 1 being poor and 10 being excellent.|After 1 week of wear|Per Protocol||Units on a Scale||Standard Deviation|Mean
806001|NCT01007838|Secondary|Muscle Strength|Bilateral knee extensor isometric strength.|Change from baseline in muscle strength at 12 weeks||||||
806002|NCT01007838|Primary|Muscle Cross Sectional Area|Muscle cross sectional area (quadriceps group) taken at midpoint slice between superior aspect of femoral head and the femoral condyle.|Change from baseline in cross sectional area at 12 weeks|Per protocol. All participants completing the study were analyzed.||cm2||Standard Deviation|Mean
806003|NCT01007916|Primary|Comfort Upon Insertion|Comfort upon insertion, as interpreted by the participant, was recorded on a questionnaire by the participant using a 10-point scale, with 1 being poor and 10 being excellent. Comfort upon insertion was assessed as a single, retrospective evaluation of 4-weeks' wear time.|4 weeks of wear|Analysis conducted per protocol, with exclusions due to major protocol deviations as determined by masked review.||Units on a Scale||Standard Deviation|Mean
806004|NCT01007942|Secondary|Trastuzumab Blood Concentrations by Leading Dose and Time Point|Pre-infusion (Cmin) and end of infusion (C2h) trastuzumab PK blood samples were collected at Cycle 3 Day 1. Only valid trastuzumab PK blood samples collected at steady state were used in the analyses.|Cycle 3, Day 1|The Safety Set consisted of all patients who received at least one dose of the study treatment and who had at least one valid post-baseline safety assessment.||ng/ml||Standard Deviation|Mean
806007|NCT01007942|Secondary|PRO: Time to Deterioration in Global Health Status/QoL Domain Score of the European Organization for the Research and Treatment of Cancer (EORTC)–Core Quality of Life Questionnaire (QLQ-C30) (by at Least 10%)|PRO = patient reported outcomes; Time to deterioration (≥ 10% worsening from baseline), in the global health status of EORTC QLQ-C30 scale was done in the 3 functional scales (emotional, physical, & social functioning [EF, PF, & SF]). It contains 30 items & is composed of multi-item scales & single-item measures. These include 5 functional scales (physical, role, emotional, social & cognitive functioning), 3 symptom scales (fatigue, pain, nausea, & vomiting), a global health status/QoL scale, and 6 single items (dyspnea, diarrhea, constipation, anorexia, insomnia & financial impact). Each of the multi-item scale includes a different set of items - no item occurs in more than 1 scale. Each item in the EORTC QLQ-C30 has 4 response categories (1=Not at all, 2= A little, 3= Quite a bit, 4= Very much) with the higher number representing a worse outcome. The global health domain score of the QLQ-C30 questionnaire was pre-specified as the primary QoL domain of interest & disclosed here.|Baseline, until disease progression or death up to about 41 months|The Full Analysis Set (FAS) consisted of all randomized patients.||months||95% Confidence Interval|Median
806008|NCT01007942|Secondary|Median Time to Deterioration of the ECOG Performance Status Score|Time to deterioration of ECOG performance status score was summarized at time of assessment. ECOG (Eastern Cooperative Oncology Group)performance scale is a standard criteria for measuring how treatment of cancer impacts their level of functioning in terms of their ability to care for themselves, daily activity, & physical ability (walking, working, etc.). Scale score ranges from 0 to 5, 5 being the worst. ECOG scale index: 0 - Fully active, able to carry on all pre-disease performance without restriction. 1 - Restricted in physically strenuous activity but ambulatory & able to carry out work of a light or sedentary nature, e.g., light housework, office work. 2 - Ambulatory & capable of all self-care but unable to carry out any work activities. Up & about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 - Dead|baseline, until disease progression or death up to about 41 months|The Full Analysis Set (FAS) consisted of all randomized patients.||months||95% Confidence Interval|Median
806009|NCT01007942|Secondary|Clinical Benefit Rate (CBR)|CBR was defined as the percentage of participants whose best overall response, according to RECIST, was either complete response (CR), a partial response (PR) or stable disease (SD) lasting for at least 24 weeks. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; SD = Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD; PD = At least a 20% increase in the sum of the longest diameter of all measured target lesions, taking as reference the smallest sum of longest diameter of all target lesions recorded at or after baseline.|Every 6 weeks until disease progression or death which ever occurred first up to about 41 months|The Full Analysis Set (FAS) consisted of all randomized patients.||Percentage of participants||95% Confidence Interval|Number
806010|NCT01007942|Secondary|Overall Response Rate (ORR)|ORR was defined as the percentage of participants whose best overall response was either complete response (CR) or partial response (PR) according to RECIST version 1.0. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Every 6 weeks until disease progression or death which ever occurred first up to about 41 months|The Full Analysis Set (FAS) consisted of all randomized patients.||Percentage of participants||95% Confidence Interval|Number
806011|NCT01007942|Secondary|Overall Survival (OS)|OS was defined as the time from date of randomization to the date of death from any cause. Final OS was conducted when 388 deaths occurred.|Every 3 months until death up to 41 months|The Full Analysis Set (FAS) consisted of all randomized patients.||months||95% Confidence Interval|Median
806012|NCT01007942|Primary|Progressive-free Survival (PFS) Per Investigator Assessment|PFS was defined as the time from the date of randomization to the date of first radiologically documented tumor progression or death from any cause, whichever occurs first. PFS primary analysis performed when 415 events were reached. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Every 6 weeks until disease progression or death which ever occurred first up to about 41 months|The Full Analysis Set (FAS) consisted of all randomized patients.||months||95% Confidence Interval|Median
806013|NCT01008280|Primary|Number of Heavy Drinking Days Per Two Week Segment|A heavy drinking day was defined as ≥4 drinks/ day if female or ≥5 drinks/day if male|12 weeks|||Number of heavy drinking days/2 weeks||Standard Error|Mean
806014|NCT01008280|Primary|Number of Drinks Consumed Per Two Week Segments||12 weeks|||Number of Drinks/2 Weeks||Standard Error|Mean
806015|NCT01008280|Primary|Number of Drinking Days in the Past Two Weeks||12 Weeks|||Number of Drinking Days/2 weeks||Standard Error|Mean
806016|NCT01008449|Secondary|Subject Satisfaction With Location of Scar|Satisfaction with location of scar was reported by subject using a scale of 1 - 5. A score of 1 would be the worst location of a scar and a score of 5 would be the best location of a scar|at end of follow-up, 4 - 6 weeks post partum|||units on a scale||Inter-Quartile Range|Median
806017|NCT01008449|Secondary|Subject Satisfaction With Comfort With Scar|Scar discomfort satisfaction was reported by subject perception using a scale of 1 - 5. A score of 1 would be the worst comfort and a score of 5 would be the best comfort|at end of follow-up, 4 - 6 weeks post partum|||units on a scale||Inter-Quartile Range|Median
806018|NCT01008449|Secondary|Subject Reported Satisfaction With Appearance of Scar|Subject reported satisfaction of the scar appearance was assessed by using a scale of 1 - 5 with 1 being worst appearance and 5 being best appearance|4 - 6 weeks post delivery|||units on a scale||Inter-Quartile Range|Median
806019|NCT01008449|Secondary|Post Operative Pain - 72 - 96 Hours Post Delivery|the visual analog pain scale was used. The range is 0 to 10 for reporting pain: 0 = no pain and 10 = unbearable distress|72 - 96 hours post delivery|||units on a scale||Inter-Quartile Range|Median
806020|NCT01008449|Secondary|Post Operative Pain - 4 - 6 Weeks Post Delivery|the visual analog pain scale was used. The range is 0 to 10 for reporting pain: 0 = no pain and 10 = unbearable distress|at end of follow-up, 4 - 6 weeks post partum|||units on a scale||Inter-Quartile Range|Median
806023|NCT01008449|Primary|Percent of Subjects With Composite Wound Morbidity.|this outcome measure included a composite of either disruption and/ or infection of the wound at 4 - 6 weeks post partum. The number of subjects experiencing wound disruption and or wound infection at 4 - 6 weeks post delivery was assessed|4-6 weeks post partum|||percentage of subjects|||Number
806024|NCT01008475|Secondary|Time to Treatment Failure (TTF)|TTF was defined as the time from randomization to treatment discontinuation for any reason. For subjects on drug at the analysis cut off date or lost to follow up, TTF was censored at the trial discontinuation date or at the analysis cut off date, whichever occurred first.|Time from randomization until discontinuation assessed up to 18 months (i.e data cut-off date: 09 Oct 2013)|ITT analysis set included all the subjects who were randomized into the trial.||months||95% Confidence Interval|Median
806025|NCT01008475|Secondary|Number of Subjects With Tumor Response|Tumor response was defined as the presence of at least 1 confirmed complete response (CR) or confirmed partial response (PR) as judged by RECIST version 1.0. CR was defined for target lesions (TLs) as the disappearance of all lesions, and for non-target lesions (NTLs) as the disappearance of all non-target non-measurable lesions and/or normalization of serum levels of tumor markers. PR was defined for TLs as at least a 30 percent (%) decrease from baseline (BL) in the sum of longest diameter (SLD) of TLs.|Time from randomization up to 18 months (i.e data cut-off date: 09 Oct 2013)|ITT analysis set included all the subjects who were randomized into the trial.||Subjects|||Number
806026|NCT01008475|Secondary|Time to Progression (TTP)|TTP was defined as the time from the date of randomization to the date of objective radiographic disease progression (PD). PD per RECIST v 1.0 was defined as at least 20% increase in the sum of the longest diameter of target lesions, taking as the reference the smallest sum of longest diameters recorded since treatment started, or unequivocal progression of existing non-target lesion or appearance of new lesions. For subjects who did not progress or who were without any post baseline tumor assessment, TTP was censored at their last tumor assessment date, or at the randomization date, whichever occurred last.|Time from randomization until disease progression assessed up to 18 months (i.e data cut-off date: 09 Oct 2013)|ITT analysis set included all the subjects who were randomized into the trial.||months||95% Confidence Interval|Median
806027|NCT01008475|Secondary|Overall Survival (OS) Time|OS was defined as the time from the date of randomization to the date of death from any cause. For subjects who were still alive at the analysis cut off date or lost to follow up, survival was censored at the last recorded date the subject was known to be alive or at the analysis cut off date, whichever occurred first.|Time from randomization until death assessed up to 18 months (i.e data cut-off date: 09 Oct 2013)|ITT analysis set included all the subjects who were randomized into the trial.||months||95% Confidence Interval|Median
806028|NCT01008475|Primary|Randomized Part: Progression Free Survival (PFS)|PFS was defined as the time from the randomization date to first documented sign of objective radio-graphic disease progression (PD) as per Response Evaluation Criteria In Solid Tumors version 1. (RECIST 1.0) or death from any cause if reported within 12 weeks from the last tumor assessment. PD per RECIST v 1.0 was defined as at least 20% increase in the sum of the longest diameter of target lesions, taking as the reference the smallest sum of longest diameters recorded since treatment started, or unequivocal progression of existing non-target lesion or appearance of new lesions. Subjects who did not progress or died at the time of analyses, or subjects who died without previously radio-graphically documented PD and death was observed after more than 12 weeks of last tumor assessment without progression, these subjects were censored at their last tumor assessment date or date of randomization, whichever occurred last.|Time from randomization until progressive disease or death; assessed up to 18 months (i.e data cut-off date: 09 Oct 2013)|Intention-to-treat (ITT) analysis set included all the subjects who were randomized into the treatment groups.||months||95% Confidence Interval|Median
806029|NCT01008475|Primary|Safety Part: Number of Subjects Experiencing DLTs (Dose Limiting Toxicity)|DLT was defined as any Grade 4 hematologic toxicity or Grade 3/4 non-hematologic toxicity assessed as related to trial treatment by the Investigator and/or Sponsor and confirmed by the safety monitoring committee (SMC) to be relevant to the combination treatment within the first cycle of therapy. Any Grade 3 or 4 non haematological toxicity, any Grade 4 hematological toxicity, treatment related deaths within the first 2 weeks of therapy. Toxicities excluded from DLT: alopecia, rash, nausea, vomiting and hypomagnesemia of Grade 3 or 4 severity, Grade 4 neutropenia or leukopenia lasting for =< 5 days and not associated with fever; Single laboratory values out of normal range without any clinical correlation and resolve within 7 days; Grade 3 or 4 diarrhoea without adequate supportive care. Adequate supportive care has been administered and Grade 4 diarrhea persists (investigator decision); isolated Grade 4 lymphocytopenia and thrombocytopenia without clinical correlation.|Time from the first dose of study drug up to 2 weeks|Dose-escalation analysis set included subjects who received atleast 1 dose of EMD 525797 and who met atleast 1 of the following: Did not withdraw before the end of DLT evaluation period (2 weeks from 1st drug intake) for reasons other than DLT;those who experienced a DLT during this period and received 1 dose of EMD 525797 as per cohort allocation.||subjects|||Number
806030|NCT01008553|Secondary|Number of Participants Evaluated as Per Physician's Overall Assessment - Double-Blind Period|Physician's global assessment of therapeutic efficacy (effectiveness) of the study drug was measured on a 2-point scale where 1 = effective and 2 = not effective.|Day 1 and 85 or final evaluation (double-blind period)|The FAS population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.||Participants|||Number
806031|NCT01008553|Secondary|Number of Participants Evaluated as Per Physician's Overall Assessment - Titration Period|Physician's global assessment of therapeutic efficacy (effectiveness) of the study drug was measured on a 2-point scale where 1 = effective and 2 = not effective.|Day 29 or final evaluation (Titration period)|The FAS1 population included all the randomly assigned participants with the exception of participants with pre-defined criteria.||Participants|||Number
806051|NCT01008618|Secondary|Number of Participants Evaluated as Per Physician's Overall Assessment - Titration Period|Physician's global assessment of therapeutic efficacy (effectiveness) of the study drug was measured on a 2-point scale where 1 = effective and 2 = not effective.|Day 29 or final evaluation (Titration period)|The FAS1 population included all the randomly assigned participants with the exception of participants with pre-defined criteria.||Participants|||Number
820574|NCT01145898|Primary|3-year Change in OA EDV|Measurement of change in ocular blood flow - ophthalmic artery end diastolic velocity|Baseline and 36 month visits|||cm/sec||Standard Error|Mean
806032|NCT01008553|Secondary|Short-Form 36-Item Health Survey Version 2.0 (SF-36v2) Score - Double-Blind Period|The SF-36v2 is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; role emotional, social functioning and mental health contribute to mental component; and social functioning, vitality, and general health contribute to both. All scores are based on a scale from 0 to 100, with higher scores defining more favorable health state.|Day 1 and 85 or final evaluation (double-blind period)|The FAS population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.||Units on a scale||Standard Deviation|Mean
806033|NCT01008553|Secondary|Short-Form 36-Item Health Survey Version 2.0 (SF-36v2) Score - Titration Period|The SF-36v2 is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; role emotional, social functioning and mental health contribute to mental component; and social functioning, vitality, and general health contribute to both. All scores are based on a scale from 0 to 100, with higher scores defining more favorable health state.|Day 1 and 29 or final evaluation (Titration period)|The FAS1 population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.||Units on a scale||Standard Deviation|Mean
806034|NCT01008553|Secondary|Brief Pain Inventory Short Form (BPI-sf) Score - Double-Blind Period|The BPI-sf total score is an average of the pain interference score (mean value for the nine BPI-sf questions [questions inquiring about the extent of interference with activities by pain, where the extent is ranked from 0 (does not interfere) to 10 (completely interferes)]) and pain subscale score (mean value for the scores for BPI-sf questions 3, 4, 5 and 6 [questions inquiring about the extent of pain, where the extent is ranked from 0 (no pain) to 10 (pain as bad as you can imagine)]). Total score ranges from 0 to 10 with higher values indicating more pain.|Day 1 and 85 or final evaluation (double-blind period)|The FAS population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.||Units on a scale||Standard Deviation|Mean
806035|NCT01008553|Secondary|Brief Pain Inventory Short Form (BPI-sf) Score - Titration Period|The BPI-sf total score is an average of the pain interference score (mean value for the nine BPI-sf questions [questions inquiring about the extent of interference with activities by pain, where the extent is ranked from 0 (does not interfere) to 10 (completely interferes)]) and pain subscale score (mean value for the scores for BPI-sf questions 3, 4, 5 and 6 [questions inquiring about the extent of pain, where the extent is ranked from 0 (no pain) to 10 (pain as bad as you can imagine)]). Total score ranges from 0 to 10 with higher values indicating more pain.|Day 1 and 29 or final evaluation (Titration period)|The FAS1 population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.||Units on a scale||Standard Deviation|Mean
806036|NCT01008553|Secondary|Number of Doses of Rescue Treatment Per Day - Double-Blind Period|If a breakthrough pain occurred or the analgesic efficacy became insufficient, a fast-acting oral morphine was administered. At such instances, one-time dose of the rescue treatment was administered as per the pre-defined criteria. During hospitalization, Investigator, Sub-investigator or Study Collaborator recorded in the medical record and during the out-patient period, the participants were instructed to describe the name of rescue treatment, date and time of treatment, and one-time dose in the participant's diary.|Day 1 and 85 or final evaluation (double-blind period)|The FAS population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.||Treatments per day||Standard Deviation|Mean
806037|NCT01008553|Secondary|Number of Doses of Rescue Treatment Per Day - Titration Period|If a breakthrough pain occurred or the analgesic efficacy became insufficient, a fast-acting oral morphine was administered. At such instances, one-time dose of the rescue treatment was administered as per the pre-defined criteria. During hospitalization, Investigator, Sub-investigator or Study Collaborator recorded in the medical record and during the out-patient period, the participants were instructed to describe the name of rescue treatment, date and time of treatment, and one-time dose in the participant's diary.|Day 1 and 29 or final evaluation (Titration period)|The FAS1 population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.||Treatments per day||Standard Deviation|Mean
806038|NCT01008553|Secondary|Number of Participants Evaluated as Per Participant's Overall Assessment - Double-Blind Period|The participant assessed his/her satisfaction with the therapeutic efficacy by the following 5 grades: “Extremely satisfied”, “Satisfied”, “Neither satisfied nor dissatisfied”, “Dissatisfied” and “Dissatisfied very much”. The results were reported as Category 1 = At least “Neither satisfied nor dissatisfied”, which included participants with general evaluation of “Extremely satisfied” to “Neither satisfied nor dissatisfied”, and Category 2 = At least “Satisfied”, which included participants with general evaluation of “Extremely satisfied” to “Satisfied”.|Day 1 and 85 or final evaluation (double-blind period)|The FAS population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.||Participants|||Number
806129|NCT01009333|Secondary|Number of Pads Per Day|In a diary, subjects are asked to provide number of pads they used per day.|three weeks|||Pads Per Day||Standard Deviation|Mean
808676|NCT01034657|Secondary|Event-free Survival (EFS) - Overall Period|EFS was defined as the time from start of treatment to failure or death from any cause.|52 weeks|Event-free survival could not be evaluated because there was no response, no progression or no disease-free period.|||||
806039|NCT01008553|Secondary|Number of Participants Evaluated as Per Participant's Overall Assessment - Titration Period|The participant assessed his/her satisfaction with the therapeutic efficacy by the following 5 grades: “Extremely satisfied”, “Satisfied”, “Neither satisfied nor dissatisfied”, “Dissatisfied” and “Dissatisfied very much”. The results were reported as Category 1 = At least “Neither satisfied nor dissatisfied”, which included participants with general evaluation of “Extremely satisfied” to “Neither satisfied nor dissatisfied”, and Category 2 = At least “Satisfied”, which included participants with general evaluation of “Extremely satisfied” to “Satisfied”.|Day 1 and 29 or final evaluation (Titration period)|The FAS1 population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.||Participants|||Number
806040|NCT01008553|Secondary|Pain Visual Analog Scale (VAS) Score - Double-Blind Period|The intensity of average pain (degree of pain) felt by the participants in daily living throughout the day on a “100-millimeter (mm) VAS scale” by drawing a slash. The left margin (0 mm) was considered “No pain at all”, and the right margin (100 mm) was considered “Severer pain than this is inconceivable”. The length (mm) from the left margin to the slash is measured. Mean VAS score during 3 days before the end of titration period and during 3 days before the end of double-blind period was reported.|Day 27-29 (Titration period) and Day 83-85 (double-blind period)|The FAS population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.||mm||Standard Deviation|Mean
806041|NCT01008553|Secondary|Pain Visual Analog Scale (VAS) Score - Titration Period|The intensity of average pain (degree of pain) felt by the participants in daily living throughout the day on a “100-millimeter (mm) VAS scale” by drawing a slash. The left margin (0 mm) was considered “No pain at all”, and the right margin (100 mm) was considered “Severer pain than this is inconceivable”. The length (mm) from the left margin to the slash is measured. Mean VAS score during 3 days before the end of Screening period and during 3 days before the end of titration period was reported.|Day 12-14 (Screening period) and Day 27-29 (Titration period)|Full analysis set in Period 1 (FAS1) population included all the randomly assigned participants with the exception of participants with pre-defined criteria. 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.||mm||Standard Deviation|Mean
806042|NCT01008553|Primary|Time From the Initial Day of Application in Double-Blind Period to Withdrawal Because of Insufficient Analgesic Efficacy|Time from start of double-blind (researchers and participants were unaware of the treatment) period to withdrawal because of insufficient analgesic efficacy based on any of the pre-defined discontinuation criteria was noted.|Day 1 up to Day 85 (double-blind period) and Day 92 (discontinuation of the study)|Full analysis set (FAS) population included all the randomly assigned participants with the exception of participants with pre-defined criteria.||Days||95% Confidence Interval|Median
806043|NCT01008605|Secondary|Number of Participants Providing Comments to Any Question on the Participant Assessment Tool|Number of participants providing comments on questions in the Participant Assessment Tool. Questions were as follows: were instructions clear, were instructions useful, which was the most difficult step, and was the syringe easy to use.|Day 1|FAS. Each participant tested one device/dose combination.||participants|||Number
806044|NCT01008605|Secondary|Time Required to Perform Each Step While Using the Caverject Impulse Delivery System|Steps involved while using the Caverject Impulse Delivery System included assembly, mixing the dose, de-aeration, setting the dose, and injecting the dose.|Day 1|FAS. Each participant tested one device/dose combination. n = number of participants with available data.||seconds||Standard Deviation|Mean
806045|NCT01008605|Secondary|Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 4|Participant Assessment Tool, Question 4: Syringe easy to use? Participant responses were reported as follows: Very Easy, Somewhat Easy, Somewhat Difficult, Very Difficult|Day 1|FAS. Each participant tested one device/dose combination.||participants|||Number
806046|NCT01008605|Secondary|Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 3|Participant Assessment Tool, Question 3: Most difficult step? Participant responses were reported as follows: No Steps Particularly Difficult, Attaching Needle, Mixing Solution, Getting The Air Out Of Syringe, Dialing Dose, Pushing Plunger, Other.|Day 1|FAS. Each participant tested one device/dose combination.||participants|||Number
806047|NCT01008605|Secondary|Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 2|Participant Assessment Tool, Question 2: Instructions provided were clear? Participant responses were reported as follows: Very Clear, Somewhat Clear, Not Very Clear, Not Clear At All.|Day 1|FAS. Each participant tested one device/dose combination.||participants|||Number
806048|NCT01008605|Secondary|Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 1|Participant Assessment Tool, Question 1: Instructions provided were useful? Participant responses were reported as follows: Very Useful, Somewhat Useful, Not Very Useful, Not Useful At All.|Day 1|FAS. Each participant tested one device/dose combination.||participants|||Number
806049|NCT01008605|Primary|Percentage of Participants Who Successfully Operated the Caverject Impulse Delivery System|Percentage of participants who were able to successfully expel the selected dose from the Caverject Impulse Delivery System when relying on the modified Instructions for Use. The process was considered successful if the lower bound of the 95% confidence interval (CI) was more than (>) 80% overall.|Day 1|Full Analysis Set (FAS): All eligible participants who read the instructions and attempted to deliver Alprostadil using the Caverject Impulse Delivery System. Each participant tested one device/dose combination.||percentage of participants|||Number
806050|NCT01008618|Secondary|Number of Participants Evaluated as Per Physician's Overall Assessment - Double-Blind Period|Physician's global assessment of therapeutic efficacy (effectiveness) of the study drug was measured on a 2-point scale where 1 = effective and 2 = not effective.|Day 1 and 85 or final evaluation (double-blind period)|The FAS population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.||Participants|||Number
806052|NCT01008618|Secondary|Short-Form 36-Item Health Survey Version 2.0 (SF-36v2) - Double-Blind Period:|The SF-36v2 is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; role emotional, social functioning and mental health contribute to mental component; and social functioning, vitality, and general health contribute to both. All scores are based on a scale from 0 to 100, with higher scores defining more favorable health state.|Day 1 and 85 or final evaluation (double-blind period)|The FAS population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.||Units on a scale||Standard Deviation|Mean
806053|NCT01008618|Secondary|Short-Form 36-Item Health Survey Version 2.0 (SF-36v2) - Titration Period|The SF-36v2 is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; role emotional, social functioning and mental health contribute to mental component; and social functioning, vitality, and general health contribute to both. All scores are based on a scale from 0 to 100, with higher scores defining more favorable health state.|Day 1 and 29 or final evaluation (Titration period)|The FAS1 population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.||Units on a scale||Standard Deviation|Mean
806054|NCT01008618|Secondary|Brief Pain Inventory Short Form (BPI-sf) Score - Double-Blind Period|The BPI-sf total score is an average of the pain interference score (mean value for the nine BPI-sf questions [questions inquiring about the extent of interference with activities by pain, where the extent is ranked from 0 (does not interfere) to 10 (completely interferes)]) and pain subscale score (mean value for the scores for BPI-sf questions 3, 4, 5 and 6 [questions inquiring about the extent of pain, where the extent is ranked from 0 (no pain) to 10 (pain as bad as you can imagine)]). Total score ranges from 0 to 10 with higher values indicating more pain.|Day 1 and 85 or final evaluation (double-blind period)|The FAS population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.||Units on a scale||Standard Deviation|Mean
806055|NCT01008618|Secondary|Brief Pain Inventory Short Form (BPI-sf) Score - Titration Period|The BPI-sf total score is an average of the pain interference score (mean value for the nine BPI-sf questions [questions inquiring about the extent of interference with activities by pain, where the extent is ranked from 0 (does not interfere) to 10 (completely interferes)]) and pain subscale score (mean value for the scores for BPI-sf questions 3, 4, 5 and 6 [questions inquiring about the extent of pain, where the extent is ranked from 0 (no pain) to 10 (pain as bad as you can imagine)]). Total score ranges from 0 to 10 with higher values indicating more pain.|Day 1 and 29 or final evaluation (Titration period)|The FAS1 population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.||Units on a scale||Standard Deviation|Mean
806056|NCT01008618|Secondary|Number of Doses of Rescue Treatment Per Day - Double-Blind Period|If a breakthrough pain occurred or the analgesic efficacy became insufficient, a fast-acting oral morphine was administered. At such instances, one-time dose of the rescue treatment was administered as per the pre-defined criteria. During hospitalization, Investigator, Sub-investigator or Study Collaborator recorded in the medical record and during the out-patient period, the participants were instructed to describe the name of rescue treatment, date and time of treatment, and one-time dose in the participant's diary. The mean number of treatments per day at each assessment time was reported.|Day 1 and 85 or final evaluation (double-blind period)|The FAS population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.||Treatments per day||Standard Deviation|Mean
806057|NCT01008618|Secondary|Number of Doses of Rescue Treatment Per Day - Titration Period|If a breakthrough pain occurred or the analgesic efficacy became insufficient, a fast-acting oral morphine was administered. At such instances, one-time dose of the rescue treatment was administered as per the pre-defined criteria. During hospitalization, Investigator, Sub-investigator or Study Collaborator recorded in the medical record and during the out-patient period, the participants were instructed to describe the name of rescue treatment, date and time of treatment, and one-time dose in the participant's diary. The mean number of treatments per day at each assessment time was reported.|Day 1 and 29 or final evaluation (Titration period)|The FAS1 population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.||Treatments per day||Standard Deviation|Mean
806058|NCT01008618|Secondary|Number of Participants Evaluated as Per Participant's Overall Assessment - Double-Blind Period|The participant assessed his/her satisfaction with the therapeutic efficacy by the following 5 grades: “Extremely satisfied”, “Satisfied”, “Neither satisfied nor dissatisfied”, “Dissatisfied” and “Dissatisfied very much”. The results were reported as Category 1 = At least “Neither satisfied nor dissatisfied”, which included participants with general evaluation of “Extremely satisfied” to “Neither satisfied nor dissatisfied”, and Category 2 = At least “Satisfied”, which included participants with general evaluation of “Extremely satisfied” to “Satisfied”.|Day 1 and 85 or final evaluation (double-blind period)|The FAS population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.||Participants|||Number
806238|NCT01012167|Secondary|Side Effect Checklist (SEC) - Mucosal Ulceration|"Percentage of participants with new onset or worsening compared to baseline of Mucosal Ulceration rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.||percentage of participants|||Number
806059|NCT01008618|Secondary|Number of Participants Evaluated as Per Participant's Overall Assessment - Titration Period|The participant assessed his/her satisfaction with the therapeutic efficacy by the following 5 grades: “Extremely satisfied”, “Satisfied”, “Neither satisfied nor dissatisfied”, “Dissatisfied” and “Dissatisfied very much”. The results were reported as Category 1 = At least “Neither satisfied nor dissatisfied”, which included participants with general evaluation of “Extremely satisfied” to “Neither satisfied nor dissatisfied”, and Category 2 = At least “Satisfied”, which included participants with general evaluation of “Extremely satisfied” to “Satisfied”.|Day 1 and 29 or final evaluation (Titration period)|The FAS1 population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.||Participants|||Number
806060|NCT01008618|Secondary|Pain Visual Analog Scale (VAS) Score - Double-Blind Period|The intensity of average pain (degree of pain) felt by the participants in daily living throughout the day on a “100-millimeter (mm) VAS scale” by drawing a slash. The left margin (0 mm) was considered “No pain at all”, and the right margin (100 mm) was considered “Severer pain than this is inconceivable”. The length (mm) from the left margin to the slash is measured. Mean VAS score during 3 days before the end of titration period and during 3 days before the end of double-blind period was reported.|Day 27-29 (Titration period) and Day 83-85 (double-blind period)|The FAS population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.||mm||Standard Deviation|Mean
806061|NCT01008618|Secondary|Pain Visual Analog Scale (VAS) Score - Titration Period|The intensity of average pain (degree of pain) felt by the participants in daily living throughout the day on a “100-millimeter (mm) VAS scale” by drawing a slash. The left margin (0 mm) was considered “No pain at all”, and the right margin (100 mm) was considered “Severer pain than this is inconceivable”. The length (mm) from the left margin to the slash is measured. Mean VAS score during 3 days before the end of Screening period and during 3 days before the end of titration period was reported.|Day 12-14 (Screening period) and Day 27-29 (Titration period)|Full analysis set in Period 1 (FAS1) population included all the randomly assigned participants with the exception of participants with pre-defined criteria. 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.||mm||Standard Deviation|Mean
806062|NCT01008618|Primary|Time From the Initial Day of Application in Double-Blind Period to Withdrawal Because of Insufficient Analgesic Efficacy|Time from start of double-blind (researchers and participants were unaware of the treatment) period to withdrawal because of insufficient analgesic efficacy based on any of the pre-defined discontinuation criteria was noted.|Day 1 up to Day 85 (double-blind period) and Day 92 (discontinuation of the study)|Full analysis set (FAS) population included all the randomly assigned participants with the exception of participants with pre-defined criteria.||Days||95% Confidence Interval|Median
806063|NCT01008696|Secondary|Overall Assessment of Study Medication by Investigator|Investigator’s overall assessment of study medication based on the global symptom assessment was measured. The assessment was categorized as: 2=very good, 1=good, 0=as usual, -1=bad and -2=very bad.|Day 57|The FAS included participants who received the study medication at least once and had follow-up data that could be used after the Baseline among the participants meeting the eligibility criteria of this study. LOCF was used. Here, 'N'=participants evaluated for this outcome measure.||Units on a scale||Standard Deviation|Mean
806064|NCT01008696|Secondary|Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire|Gastroesophageal reflux disease and abdominal GI-related symptoms (heartburn, regurgitation, globus sensation, chronic cough, epigastric pain, non cardiac chest pain, hoarseness, dysphagia, abdominal distension, bloating, post-prandial discomfort, early satiety, nausea, vomiting, belching) experienced by participants were assessed and graded into 4 categories: 0 (Nothing)=No symptom, 1 (Mild)=A little but not uncomfortable, 2 (Moderate)=Present but interfering daily life activities a little, 3 (Severe)=Very uncomfortable, interfering daily life activities or sleeping.|Baseline and Day 57|The FAS included participants who received study medication at least once and had follow-up data that could be used after Baseline among participants who met eligibility criteria. Last observation carried forward (LOCF) was used. Here, 'n'=participants evaluated for particular category of this outcome measure||Units on a scale||Standard Deviation|Mean
806065|NCT01008696|Primary|Percentage of Participants Completely Cured of Reflux Esophagitis Evaluated by Endoscopy Based on CYP2C19|Reflux esophagitis evaluated by endoscopy as per LA Classification graded as: A=1 or more mucosal breaks no longer than 5 millimeter (mm) that did not extend between tops of 2 mucosal folds, B=1 or more mucosal breaks more than 5 mm long that did not extend between tops of 2 mucosal folds, C=1 or more mucosal break continuous between the tops of 2 or more mucosal folds but involves less than 75 percent of circumference, D=1 or more mucosal break involving at least 75 percent of circumference. Participants that were not categorized in any of the above mentioned grades (A to D) were considered as cured of reflux esophagitis. Participants were classified as CYP2C19 homozygous extensive, heterozygous extensive and poor metabolizers.|Day 57|The Full analysis set (FAS) included participants who received study medication at least once and had follow-up data that could be used after Baseline among participants who met eligibility criteria. Last observation carried forward (LOCF) was used. Here, 'n'=participants evaluated for particular category of this outcome measure.||Percentage of participants|||Number
806066|NCT01008722|Secondary|Termination or Slowing of Atrial Fibrillation During Ablation|Using data from electrophysiological study, to determine termination of AF into sinus rhythm or organized atrial tachycardia. or slowing by 10% in cycle length measured on the coronary sinus.|acute|||Participants|||Count of Participants
806067|NCT01008722|Primary|Survival Free of Atrial Fibrillation|Using data from cardiac implanted devices when possible, with recurrence defined as 1% recurrence, or data from intermittent 24-72 hour ambulatory ECGs, with recurrence defined as >30 seconds.|6 -12 months|||participants|||Number
806068|NCT01008904|Secondary|Difference in Quality of Life|Mayo Clinic Uniscale instrument (6 questions with each question rating 0=as bad as it can be and 10=as good as it can be). A lower score is considered to be a better outcome.|from baseline to week 5|Participants who completed treatment||units on a scale||Standard Error|Mean
806069|NCT01008904|Primary|Percent Difference in Hot Flash Activity (Score) Between Baseline and End of Treatment (Week 5)|Hot flash score (frequency x severity) at baseline was compared to the end of treatment. The number of flashes in a 24 hour day and a score combining the number and severity of hot flashes (ie, 1 point for mild, 2 points for moderate, 3 points for severe and 4 points for very severe.|from baseline to week 5|25 patients completed the complete study and were analyzed||percentage of difference||Standard Error|Mean
806070|NCT01008943|Primary|Number of Participants That Experienced AMDC Product-related Events|"If an immune response after injection or any urinary retention occurred and seemed suspicious, the physicians were consulted to determine whether the effect was likely related to the AMDC product.
No adverse events reported during the study were adjudicated as AMDC product-related."|12 months|||participants|||Number
806071|NCT01008943|Primary|Injection Procedure-related Adverse Events|AMDC treatment was administered via intrasphincteric injection. Injection procedure-related events were defined as systemic responses to the injection procedure or genitourinary events occurring within 30 days of the injection procedure that could be attributed to cystoscopy or catheterization. Since these events could be attributed to the injection procedure, results are considered independent of AMDC dose received. All injection procedure-related events self-resolved or were easily treated.|30 days|||events|||Number
806072|NCT01008943|Primary|Number of Participants That Experienced Injection Procedure-related Adverse Events|AMDC treatment was administered via intrasphincteric injection. Injection procedure-related events were defined as systemic responses to the injection procedure or genitourinary events occurring within 30 days of the injection procedure that could be attributed to cystoscopy or catheterization. Since these events could be attributed to the injection procedure, results are considered independent of AMDC dose received. All injection procedure-related events self-resolved or were easily treated.|30 days|||participants|||Number
806073|NCT01008943|Primary|Number of Participants That Experienced Biopsy Procedure-related Adverse Events|Biopsy was required to generate AMDC products. Biopsy procedure-related events were defined as systemic responses to the biopsy procedure or injury at the biopsy site. Since biopsy occurred prior to AMDC treatment, results are presented independent of AMDC dose received. All biopsy procedure-related events either self-resolved or were easily treated.|at biopsy or between biopsy and treatment, approximately 6 weeks|One patient experienced procedural dizziness.||participants|Participants||Number
806074|NCT01008969|Secondary|Percentage of Images With Detectable Sentinel Lymph Nodes (LNs) From 99mTc-sulfur Nanocolloid SPECT/CT Scans|There was only one arm for this study. All participants who had prostate cancer received 99mTc-sulfur nanocolloid injection and imaged by SPECT/CT within 3 hours of injection. The imaging studies qualitatively detected radiotracer distribution within the prostate and local lymphatic system. The detection of the radiotracer distribution was performed by experienced attending nuclear medicine physicians at UCSF. The qualitative detection includes visual lymph node uptake seen by SPECT scans overlaid on coregistered CT scans.|1 day|We reviewed the imaging results of this procedure by SPECT/CT. We calculated the percentage of images with detectable lymph nodes from SPECT/CT images in these participants.||percentage of images identifying LNs|||Number
806075|NCT01008969|Primary|Percentage of Participants Successfully Completed 99mTc-sulfur Nanocolloid SPECT/CT Within 3 Hours After Injection|Successful completion of 99mTc-sulfur nanocolloid SPECT/CT means that the images were obtained within 3 hours, and the images showed patients' lymphatic drainage.|1 day|We reviewed the imaging results of this procedure by SPECT/CT. Percentage of participants who received SPECT/CT scans of 99mTc-sulfur nanocolloid was analyzed.||Percentage of Participants|||Number
806076|NCT01008995|Secondary|The Change in Dermatology Life Quality Index (DLQI) From Baseline at Week 12.|Scores could range from 0 to 30. A lower DLQI score represents better quality of life.|Baseline (Week 0) to Week 12|Analysis was based on the subset of participants with evaluable measurements according to their randomized treatment group.||Score||Standard Deviation|Mean
806077|NCT01008995|Secondary|The Number of Patients With a Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12||Week 12|All participants were included and analyzed according to their randomized treatment group.||Participants|||Number
806078|NCT01008995|Primary|The Number of Patients Who Achieved at Least a 75% Improvement in PASI (Psoriasis Area and Severity Index) From Baseline at Week 12.|Scores could range from 0 (mild) to 72 (severe).|Baseline (Week 0) to Week 12|All participants were analyzed according to the treatment group to which they were randomized, regardless of the treatment they actually received.||Participants|||Number
806079|NCT01009034|Secondary|Determine the Area Under the Concentration Time Curve of Maraviroc in Semen.||6 months|||h*mg/L||Inter-Quartile Range|Median
806080|NCT01009034|Secondary|Determine the Extent of Maraviroc Penetration Into Semen by Obtaining Semen to Plasma Ratios Across the Dosing Interval|For each participant, the Maraviroc penetration ratio was calculated as the maximum Maraviroc concentration in the semen over the maximum Maraviroc concentration in the blood throughout the dosing interval.|Semen samples were collected 30 minutes to 1 hour before the morning dose of medication (day 1), and then at hours 1, 2, 4, 8, and 12 postdrug ingestion on days 2-6. Blood samples were collected within 1 hour of the semen sample|||ratio||Inter-Quartile Range|Mean
806081|NCT01009034|Primary|Semen to Plasma Ratio of HIV Concentration During the Dosing Interval for Dar, Evr, Mar & Ral.|We used a staggered sampling approach in which semen samples were produced by participants over several days at different sampling times relative to the morning dose of antiretrovirals. Speciﬁ- cally, semen samples were collected 30 minutes to 1 hour before the morning dose of medication (day 1), and then at hours 1, 2, 4, 8, and 12 postdrug ingestion on days 2–6. We collected corresponding blood samples within 1 hour of the semen sample. For each participant a single value (the HIV concentration ratio) was calculated as the minimum HIV concentration in the semen over the minimum HIV concentration in the blood throughout the dosing interval.|Semen samples were collected 30 minutes to 1 hour before the morning dose of medication (day 1), and then at hours 1, 2, 4, 8, and 12 postdrug ingestion on days 2-6. Blood samples were collected within 1 hour of the semen sample.|We used a staggered sampling approach in which semen samples were produced by participants over several days at different sampling times relative to the morning dose of antiretrovirals.||Inhibitory concentration ratio||Inter-Quartile Range|Median
806237|NCT01012167|Secondary|Side Effect Checklist (SEC) - Nasal Irritation|"Percentage of participants with new onset or worsening compared to baseline of Nasal Irritation rating on the SEC, by Treatment Group."|Weekly for 6 weeks|"Safety data for 56 participants exposed to study treatment minus 6 participants who had missing nasal irritation data."||percentage of participants|||Number
806082|NCT01009047|Secondary|Number of Participants With PANSS Response|The PANSS is a 30-item scale with each item rated on a scale of 1 (absent) to 7 (extreme psychopathology), designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Participants with PANSS response were defined as those who achieved greater than or equal to 20 percent or higher reduction from Baseline in the PANSS total score at Day 56 and 182.|Day 56 and 182|The ITT population included all randomly assigned participants who received at least 1 dose of double-blind study drug, had both a Baseline measurement and at least 1 Post-Baseline measurement in the double-blind phase. Last observation carried forward (LOCF) method was used.||Participants|||Number
806083|NCT01009047|Secondary|Change From Baseline in Personal and Social Performance (PSP) Scores at Day 56 and 182|The PSP scale assesses degree of a participants' dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The results of the assessment are converted to a numerical score to rate degree of difficulty (1=absent to 6=very severe) in each of the 4 domains. Based on 4 domains there will be 1 total score (total score ranges from 1 to 100, divided into 10 equal intervals). Participants with score of 71 to 100 have mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision.|Baseline, Day 56 and Day 182|The ITT population included all randomly assigned participants who received at least 1 dose of double-blind study drug, had both a Baseline measurement and at least 1 Post-Baseline measurement in the double-blind phase. Last observation carried forward (LOCF) method was used.||Units on a Scale||Standard Deviation|Mean
806084|NCT01009047|Secondary|Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Days 56 and 182|"The CGI-S rating scale is a 7-point global assessment that measures the Clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher scores indicate worsening."|Baseline, Day 56 and 182|The ITT population included all randomly assigned participants who received at least 1 dose of double-blind study drug, had both a Baseline measurement and at least 1 Post-Baseline measurement in the double-blind phase. Last observation carried forward (LOCF) method was used.||Units on a scale||Full Range|Median
806085|NCT01009047|Secondary|Number of Participants With Clinical Stability|Clinical stability is defined as a decrease of 20 percent or more from Baseline in PANSS total score and CGI-S score less than or equal to 4 at Days 56 and 182, no hospitalizations due to psychiatric illness and no emergence of clinically significant suicidal or homicidal ideation during the maintenance phase.|Day 56 and 182|The ITT population included all randomly assigned participants who received at least 1 dose of double-blind study drug, had both a Baseline measurement and at least 1 Post-Baseline measurement in the double-blind phase. Last observation carried forward (LOCF) method was used.||Participants|||Number
806086|NCT01009047|Secondary|Change From Baseline in Other PANSS Factors and Subscales at Day 56 and 182|The PANSS provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each rated on a scale of 1 (absent) to 7 (extreme).|Baseline, Day 56 and 182|The ITT population included all randomly assigned participants who received at least 1 dose of double-blind study drug, had both a Baseline measurement and at least 1 Post-Baseline measurement in the double-blind phase. Last observation carried forward (LOCF) method was used.||Units on a scale||Standard Deviation|Mean
806087|NCT01009047|Secondary|Change From Baseline in Other Marder Factors Scores at Day 56 and 182|The subscales based on marder factors are: positive symptoms, disorganised thoughts factor, uncontrolled hostility/excitement factor, and anxiety/depression factor. The symptoms are rated on a 7-point scale, with a range of 8 to 56 for positive symptoms, 7 to 49 for disorganized thoughts and 4 to 28 for Uncontrolled hostility/excitement and anxiety/depression. Higher score indicate worsening.|Baseline, Day 56 and 182|The ITT population included all randomly assigned participants who received at least 1 dose of double-blind study drug, had both a Baseline measurement and at least 1 Post-Baseline measurement in the double-blind phase. Last observation carried forward (LOCF) method was used.||Units on a scale||Standard Deviation|Mean
806088|NCT01009047|Secondary|Change From Baseline in Marder Factor Negative Symptoms Score at Day 56 and 182|The PANSS negative subscale based on marder factor assesses 7 negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).|Baseline, Day 56 and Day 182|The ITT population included all randomly assigned participants who received at least 1 dose of double-blind study drug, had both a Baseline measurement and at least 1 Post-Baseline measurement in the double-blind phase. Last observation carried forward (LOCF) method was used.||Units on a scale||Standard Deviation|Mean
806089|NCT01009047|Secondary|Change From Baseline in PANSS Total Score at Day 182|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Baseline and Day 182|The ITT population included all randomly assigned participants who received at least 1 dose of double-blind study drug, had both a Baseline measurement and at least 1 Post-Baseline measurement in the double-blind phase. Last observation carried forward (LOCF) method was used.||Units on a scale||Standard Deviation|Mean
806090|NCT01009047|Primary|Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Day 56|The PANSS is a 30-item scale with each item rated on a scale of 1 (absent) to 7 (extreme psychopathology), designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Baseline and Day 56|The intent-to-treat (ITT) population included all randomly assigned participants who received at least 1 dose of double-blind study drug, had both a Baseline measurement and at least 1 Post-Baseline measurement in the double-blind phase. Last observation carried forward (LOCF) method was used.||Units on a scale||Standard Deviation|Mean
809646|NCT01036763|Primary|Assessment of Efficacy According to Physician|Physician's assessment of efficacy within categories (positive/ negative), concurrent proportion of positive efficacy assessments by both physician and patient was determined|6 - 12 weeks|||Participants|||Number
806091|NCT01009060|Secondary|Plasma Concentrations of GSK239512 (Cmax) at Steady State After Repeat Dosing on Dose Review Visit at Any Time On-treatment|One Pharmacokinetic (PK) sample was collected within 15 minutes prior to the start of the CSSB and one PK sample was collected within 15 minutes after completion of the CSSB. ‘n’ was the number of samples available for analysis.|15 minutes prior to start and 15 minutes after completion of CSSB at Week 1,2,3,4,5,6 and 7|PK-concentration population included all par. for whom a PK sample was obtained and analyzed. Number of units analyzed are number of samples available for analysis.||nanograms per milliliter (ng/mL)|Plasma sample|Geometric Coefficient of Variation|Geometric Mean
806092|NCT01009060|Secondary|Number of Par. With Abnormal Urinalysis Parameters Values of Potential Clinical Concern|Samples for urinalysis were collected on Days 1, 7, 14, 21, 28, 35, 42, 49 and up to Day 59 (follow-up) to assess specific gravity, pH, glucose, protein, blood and ketone by dipstick and microscopic examination (if blood or protein is abnormal).|Up to Day 59|Safety Population.||Participants|||Count of Participants
806093|NCT01009060|Secondary|Number of Par. With Abnormal Clinical Chemistry Parameters Values at Any Time On-treatment|Clinical chemistry parameters: Alanine Amino Transferase (ALT), Albumin, Alkaline Phosphatase, Aspartate Amino Transferase (AST), Calcium, Creatinine, Direct Bilirubin, Gamma Glutamyl Transferase (GGT), Glucose, Potassium, Sodium, Total Bilirubin, Total protein, Urea/ Blood urea nitrogen (BUN) were presented as values of potential clinical concern at any time on treatment. Only those parameters with any abnormal value are presented.|Up to Day 59|Safety Population. Only those par. available at the indicated time point were analyzed.||Participants|||Count of Participants
806094|NCT01009060|Secondary|Number of Par. With Abnormal Hematology Parameters Values at Any Time on Treatment|Hematology parameters: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, Mean Corpuscle Hemoglobin (MCH), Mean Corpuscle Hemoglobin concentration (MCHC), Mean Corpuscle Volume (MCV), Monocytes, Platelet count, Red blood cell count (RBC), Reticulocytes, Neutrophils count and White blood cell (WBC) count were presented as values of potential clinical concern at any time on treatment. Only those parameters with any abnormal value are presented.|Up to Day 59|Safety Population. Only those par. available at the indicated time point were analyzed.||Participants|||Count of Participants
806095|NCT01009060|Secondary|Number of Par. With Heart Rate Measured Value Outside Clinical Concern Range|Heart rate readings were collected at pre-dose and then hourly post-dose until 6 hours post-dose or until the participant got discharged. It was measured in both supine and standing position. For both Std and Sup positions, heart rate data of concern was <50 or >100 and IFB >=30; <50 or >100 and DFB >=30. Data with only abnormal values were presented.|Up to Day 59|Safety Population. Only those par. available at the specified time points were analyzed.||Participants|||Count of Participants
806096|NCT01009060|Secondary|Number of Par. With Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Readings Outside Clinical Concern Range|Blood pressure readings both systolic and diastolic were collected at pre-dose and then hourly post-dose until 6 hours post-dose or until the par. got discharged. Blood pressure was measured in both standing (Std) and supine (Sup) position. Data with only abnormal values were presented. For SBP the data of concern was <90 or >140 and increase from Baseline (IFB) >=40; <90 or >140 and decrease from Baseline (DFB) >=30. For DBP the data of concern was <50 or >90 and IFB >=30; <50 or >90 and DFB >=20.|Up to Day 59|Safety Population. Only those par. available at the specified time points were analyzed.||Participants|||Count of Participants
806097|NCT01009060|Secondary|Number of Par. With Most Severe On-treatment Abnormal Electrocardiogram (ECG) Findings|Triplicate 12-lead ECGs were obtained at Baseline (screening visit). Single 12-lead ECGs were obtained at each subsequent time point during the study. Abnormal ECG findings were presented for the most severe on-treatment result.|Up to Day 59|Safety Population. Only those participants who showed most severe on-treatment abnormal ECG findings are presented.||Participants|||Count of Participants
806098|NCT01009060|Secondary|Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment.|Up to Day 59|Safety Population consisted of all randomized par. who took at least one dose of investigational product.||Participants|||Count of Participants
806099|NCT01009060|Secondary|Change From Baseline in University of California and San Diego (UCSD) Performance Based Skills Assessment (UPSA) at Week 7|The UPSA is a measure of Functional Capacity and assesses skills involved in community tasks. It is composed of five subdomains- comprehension and planning, finance, communication, mobility and house management. When combined, measures functional capacity. The comprehension and planning ranges from 0 to 14, the finance ranges from 0 to 11, the communication ranges from 0 to 12, the mobility ranges from 0 to 9, and the house management ranges from 0 to 4. Then a medication management score of 0 to 37 is added. In total, the Assessment is thus scored on a 0 to 87 scale, with higher scores indicating better performance. The Baseline was calculated as the mean of the second screening assessment and the Day 1 pre-dose assessment. If either was missing, then the Baseline value was the non-missing assessment. If both were missing, then Baseline was considered missing and the task was excluded from the analysis. Change from Baseline was score at a given time post Baseline minus Baseline score|Baseline and Week 7|ITT Population. Only those participants available at the indicated time point were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
806100|NCT01009060|Secondary|Change From Baseline in Schedule for Assessment of Negative Symptoms (SANS) at Week 7|The SANS was a tool used to assess five symptom complexes to obtain clinical ratings of negative symptoms in par. with schizophrenia. Complexes include: affective blunting; alogia (impoverished thinking); avolition/apathy; anhedonia/asociality; and disturbance of attention. Assessment was conducted on six-point scale (0=not at all to 5=severe) for a total scoring range of 0-120. Lower scores represent better performance. The Baseline was calculated as the mean of the second screening assessment and the Day 1 pre-dose assessment. If either measurement meant to be used in the mean was missing, then the Baseline value was the non-missing assessment. If both were missing, then Baseline was considered missing and the task was excluded from the analysis. Change from Baseline was calculated as score at a given time post Baseline minus score at Baseline.|Baseline and Week 7|ITT Population. Only those participants available at the indicated time point were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
806101|NCT01009060|Secondary|Change From Baseline in Brief Psychiatric Rating Scale (BPRS) at Week 7|BPRS is the clinician rating of psychiatric symptoms; higher score indicates higher severity; 18-items scored 1-7; lower score is 18 and highest score is 126. The Baseline was calculated as the mean of the second screening assessment and the Day 1 pre-dose assessment. If either measurement meant to be used in the mean was missing, then the Baseline value was the non-missing assessment. If both were missing, then Baseline was considered missing and the task was excluded from the analysis. Change from Baseline was calculated as score at a given time post Baseline minus score at Baseline.|Baseline and Week 7|ITT Population. Only those participants available at the indicated time point were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
806102|NCT01009060|Secondary|Change From Baseline in Individual Cognitive Domain Scores in MCCB at Week 7|MCCB measures functioning across various cognitive domains and is comprised of ten tests that assess seven cognitive domains (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition) Its measurements are based on timed paper-and-pencil, computerized, and orally-administered tests, as well as spatial tests using geometric cubes. MCCB composite T scores are between 40 and 60 (normal range) and < 40 (below normal range). Higher scores indicate better performance. The Baseline was calculated as the mean of the second screening assessment and the Day 1 pre-dose assessment. If either measurement meant to be used in the mean was missing, then the Baseline value was the non-missing assessment. If both were missing, then Baseline was considered missing and the task was excluded from the analysis. Change from Baseline was calculated as score at a given time post Baseline minus score at Baseline.|Baseline and Week 7|ITT Population. Only those participants at indicated time point were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
806103|NCT01009060|Secondary|Change From Baseline in Individual Cognitive Domain Scores in CSSB at Week 7|The CSSB is a computerized battery with following domains (score range): Verbal memory (0-75), working memory (0-28), motor speed (0-100), verbal fluency, attention and speed of information processing (0-110) and executive functions with higher score representing better performance. Two Baseline CSSB testing were conducted; the first on the day prior to commencing dosing (Day -1) and the other test pre-dose on Day 1: the average of the two tests was used as Baseline. Change from Baseline was calculated as score at a given time minus score at Baseline. For each individual task from the CSSB, the Baseline was calculated as the mean of the second screening assessment and the Day 1 pre-dose assessment. If either measurement was missing, then the Baseline value was the non-missing assessment. If both were missing, then Baseline was considered missing. A composite score was calculated by averaging all the measures, and then calculating a z-score of the composite.|Baseline and Week 7|ITT Population. Only those participants available at the specified time points were analyzed. Par. recruited under protocol amendment 2 were not assessed at Weeks 1, 3, 5 or 6 and hence the number of par. at these visits are lower.||Scores on a scale||Standard Error|Least Squares Mean
806104|NCT01009060|Secondary|Change From Baseline in Composite Score of Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) at Week 7|MCCB measures functioning across various cognitive domains and is comprised of ten tests that assess seven cognitive domains (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition). Its measurements are based on timed paper-and-pencil, computerized, and orally-administered tests, as well as spatial tests using geometric cubes. MCCB composite T scores are between 40 and 60 (normal range) and < 40 (below normal range). Higher scores indicate better performance. The Baseline was calculated as the mean of the second screening assessment and the Day 1 pre-dose assessment. If either measurement meant to be used in the mean was missing, then the Baseline value was the non-missing assessment. If both were missing, then Baseline was considered missing and the task was excluded from the analysis. Change from Baseline was calculated as score at a given time post Baseline minus score at Baseline.|Baseline and Week 7|ITT Population. Only those participants available at the indicated time point were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
806105|NCT01009060|Primary|Change From Baseline in Composite Score of CSSB Following Dosing With GSK239512|The CSSB is a computerized battery with following domains (score range): Verbal memory (0-75), working memory (0-28), motor speed (0-100), verbal fluency, attention and speed of information processing (0-110) and executive functions with higher score representing better performance. Two Baseline CSSB testing were conducted; the first on the day prior to commencing dosing (Day -1) and the other test pre-dose on Day 1: the average of the two tests was used as Baseline. Change from Baseline was calculated as score at a given time minus score at Baseline. For each individual task from the CSSB, the Baseline was calculated as the mean of the second screening assessment and the Day 1 pre-dose assessment. If either measurement was missing, then the Baseline value was the non-missing assessment. If both were missing, then Baseline was considered missing. A composite score was calculated by averaging all the measures, and then calculating a z-score of the composite.|Baseline and up to Week 7|ITT Population. Only those participants available at the specified time points were analyzed. Par. recruited under protocol amendment 2 were not assessed at Weeks 1, 3, 5 or 6 and hence the number of par. at these visits are lower.||Scores on a scale||Standard Error|Least Squares Mean
806106|NCT01009086|Secondary|Change From Baseline to Week 24 in Total Modified Van Der Heijde-Sharp (vdH-S) Score for the Combined Radiographic Data From Studies CNTO1275PSA3001 and CNTO1275PSA3002|The modified vdH-S score is a radiographic evaluation of hand and feet erosions and joint space narrowing (JSN) for 20 joints per hand and 6 joints per foot with a total score ranging from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score and positive score changes indicate more radiographic damage and radiographic progression, respectively. As per protocol, analysis for this outcome measure used pooled data from 2 studies (CNTO1275PSA3001 and PSA3002) because initial power assumptions showed that 900 participants would be required to evaluate impact of ustekinumab on structural damage (SD) progression. The 2 studies, (which had similar study designs and dosing regimens with difference to prior exposure to anti-tumor necrosis factor alpha (TNFα) therapies), were intended to independently measure efficacy in terms of signs, symptoms and physical function, while effects on SD progression is provided from an integrated analysis.|Day 1 (Baseline) and Week 24|Analysis included: (1) combined data from studies CNTO1275PSA3001 (NCT01009086) and CNTO1275PSA3002 (NCT01077362) and (2) all participants randomly assigned to a treatment group.||Score on a scale||Standard Deviation|Mean
819094|NCT01132820|Primary|Incidence of Adverse Effects as Assessed by the National Cancer Institute CTCAE v. 4.0|Adverse Events (Grade 3 or higher)|Up to 5 years|Eligible and treated patients||Participants|||Count of Participants
806107|NCT01009086|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 70 Response at Week 24|"An ACR 70 response is defined as a greater than or equal to 70 percent improvement from baseline in swollen (66 joints) and tender (68 joints) joint counts and greater than or equal to 70 percent improvement in 3 of the following 5 assessments: 1) Participant's assessment of pain by Visual Analog Scale (VAS) (0-10 cm), 2) Participant's global assessment of disease activity by VAS (0-10 cm), 3) Physician's global assessment of disease activity by VAS (0-10 cm) 4) Participant's assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas) and 5) C reactive protein."|Week 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment. For early escape, data at or prior to Week 16 were carried forward through Week 24.||Percentage of participants|||Number
806108|NCT01009086|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Week 24|"An ACR 50 response is defined as a greater than or equal to 50 percent improvement from baseline in swollen (66 joints) and tender (68 joints) joint counts and greater than or equal to 50 percent improvement in 3 of the following 5 assessments: 1) Participant's assessment of pain by Visual Analog Scale (VAS) (0-10 cm), 2) Participant's global assessment of disease activity by VAS (0-10 cm), 3) Physician's global assessment of disease activity by VAS (0-10 cm) 4)Participant's assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas) and 5) C reactive protein."|Week 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment. For early escape, data at or prior to Week 16 were carried forward through Week 24.||Percentage of participants|||Number
806109|NCT01009086|Secondary|Percentage of Participants (With >= 3% Baseline Body Surface Area (BSA) Psoriatic Involvement) Who Achieved a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 24|The PASI is a physician-administered assessment tool used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). A PASI 75 response is defined as greater than or equal to 75 percent improvement in PASI score from baseline.|Week 24|All participants randomly assigned to a treatment group, regardless of whether they received the assigned treatment. For early escape, data at or prior to Week 16 were carried forward through Week 24. Only participants with >=3% baseline BSA psoriatic involvement were included in this analysis.||Percentage of participants|||Number
806110|NCT01009086|Secondary|"Change From Baseline to Week 24 in the Disability Index Score as Measured With the Disability Index of the Health Assessment Questionnaire (HAQ-DI)"|The HAQ-DI is 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0 (no difficulty), to 3 (inability to perform a task in that area). The average score across the functional areas yields an overall HAQ-DI score which ranges from 0 (no disability) to 3 (completely disabled). In psoriatic arthritis, a decrease in score of 0.30 indicates clinically meaningful improvement.|Day 1 (Baseline) and Week 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment. For early escape, data at or prior to Week 16 were carried forward through Week 24.||Score on a scale||Standard Deviation|Mean
806111|NCT01009086|Primary|Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 24.|"An ACR 20 response is defined as a greater than or equal to 20 percent improvement from baseline in swollen (66 joints) and tender (68 joints) joint counts and greater than or equal to 20 percent improvement in 3 of the following 5 assessments: 1) Participant's assessment of pain by Visual Analog Scale (VAS) (0-10 cm), 2) Participant's global assessment of disease activity by VAS (0-10 cm), 3) Physician's global assessment of disease activity by VAS (0-10 centimeters [cm]) 4) Participant's assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas) and 5) C reactive protein."|Week 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment. For early escape, data at or prior to Week 16 were carried forward through Week 24.||Percentage of participants|||Number
806112|NCT01009099|Primary|Exercise Duration (Time Walked on the Constant Workrate Treadmill Test)|The primary outcome measure is a comparison of time walked on the constant workrate treadmill best at 12 weeks.|baseline and 12 weeks|Patients who completed 12 weeks of exercise training were analyzed. There was one patient in each group that did not complete the treadmill test at 12 weeks although they completed other secondary outcome measures. Although they did not complete this measure, they remained in the study and were not counted as a drop.||minutes||Standard Deviation|Mean
806113|NCT01009138|Secondary|Health-care Costs: Medication Intake|Several aspects of interest regarding diabetes-related health-care costs were assessed in order to evaluate potential reductions of health-care costs following the treatment. Measurement was performed using retrospective interview refering to the previous 6 months: The assessed aspects were 1.) the number of out-patient medical appointments as a measure of costs related to health-care utilisation, 2.) the number of days on sick leave as a measure of costs related to non-productive time and 3.) the number of daily taken prescription medications as a measure of costs related to medication intake. For each aspect, the difference of the numbers between baseline and 12 month follow up was calculated.|Baseline, 12 months-FU|||number of daily medications/half year||Standard Deviation|Mean
806114|NCT01009138|Secondary|Health-care Costs: Non-productive Time|Several aspects of interest regarding diabetes-related health-care costs were assessed in order to evaluate potential reductions of health-care costs following the treatment. Measurement was performed using retrospective interview refering to the previous 6 months: The assessed aspects were 1.) the number of out-patient medical appointments as a measure of costs related to health-care utilisation, 2.) the number of days on sick leave as a measure of costs related to non-productive time and 3.) the number of daily taken prescription medications as a measure of costs related to medication intake. For each aspect, the difference of the numbers between baseline and 12 month follow up was calculated.|Baseline, 12 months-FU|||number of days on sick leave/half year||Standard Deviation|Mean
806239|NCT01012167|Secondary|Side Effect Checklist (SEC) - Malaise|"Percentage of participants with new onset or worsening compared to baseline of Malaise rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.||percentage of participants|||Number
806115|NCT01009138|Secondary|Health-care Costs: Health-care Utilisation|Several aspects of interest regarding diabetes-related health-care costs were assessed in order to evaluate potential reductions of health-care costs following the treatment. Measurement was performed using retrospective interview refering to the previous 6 months: The assessed aspects were 1.) the number of out-patient medical appointments as a measure of costs related to health-care utilisation, 2.) the number of days on sick leave as a measure of costs related to non-productive time and 3.) the number of daily taken prescription medications as a measure of costs related to medication intake. For each aspect, the difference of the numbers between baseline and 12 month follow up was calculated.|Baseline, 12 months-FU|||number of medical appointment/half year||Standard Deviation|Mean
806116|NCT01009138|Secondary|Inflammatory Marker Hs-CRP|The inflammatory marker high sensitivity C-reactive protein (hs-CRP) was assessed as measure of distress-related immune activity. The differences of the serum-concentrations between baseline and 12 month follow up were calculated.|Baseline, 12 month FU|||mg/dl||95% Confidence Interval|Mean
806117|NCT01009138|Secondary|Inflammatory Marker IL-1Ra|The inflammatory marker Interleukin 1 receptor antagonist (IL-1Ra) was assessed as measure of distress-related immune activity. The differences of the serum-concentrations between baseline and 12 month follow up were calculated.|Baseline, 12 month FU|||pg/ml||95% Confidence Interval|Mean
806118|NCT01009138|Secondary|Inflammatory Marker IL-6|The inflammatory marker Interleukin 6 (IL-6) was assessed as measure of distress-related immune activity. The differences of the serum-concentrations between baseline and 12 month follow up were calculated.|Baseline, 12 month FU|||pg/ml||95% Confidence Interval|Mean
806119|NCT01009138|Secondary|Glycemic Control (HbA1c)|The HbA1c was used as measure of glycemic control. All blood samples were analysed in a central laboratory using the Bio-Rad II Turbo analyser; the measurement units were %-points. Based on the measurement at baseline and 12-month follow up, the difference of the HbA1c values between baseline and 12 month follow up was calculated.|Baseline, 12 month FU|||%-points||Standard Deviation|Mean
806120|NCT01009138|Secondary|Diabetes Acceptance (AADQ Score)|The Acceptance and Action Diabetes Questionnaire (AADQ) was used to assessment of diabetes acceptance. Using 11 items on diabetes-related experiential avoidance behaviours and a 5-point Likert response scale (1 - 5), the AADQ estimates the overall level of diabetes acceptance. Item scores are summed to a total score between 11 and 55 with higehr scores indicating better acceptance. Based on the measurement of diabetes acceptance at baseline and 12-month follow up, the difference of the test scores between baseline and 12 month follow up was calculated.|Baseline, 12 month FU|||Scores on a scale||Standard Deviation|Mean
806121|NCT01009138|Secondary|Diabetes Self-Care (SDSCA Score)|The Summary of Diabetes Self-Care Activities Measure (SDSCA) was used to assess diabetes self-care. The SDSCA assesses the number of days of the previous week (0 - 7) on which several specific self-care activities (appropriate diet, physical activity, self-monitoring of blood glucose, foot care) were performed. The item scores are summed and averaged to a total score from 0 to 7 with higher scores indicating better overall self-care. Based on the measurement of diabetes self-care at baseline and 12-month follow up, the difference of the test scores between baseline and 12 month follow up was calculated.|Baseline, 12 month FU|||Scores on a scale||Standard Deviation|Mean
806122|NCT01009138|Secondary|Diabetes-specific Distress (PAID Score)|The Problem areas in Diabetes Scale (PAID) was used to assess diabetes-specific distress. The PAID assesses diabetes-specific distress using 20 items and a five-point Likert scale (0 - 4). Item scores are summed and transformed to a range from 0 - 100 with higher scores indicating higher distress. Based on the measurement of diabetes-specific distress at baseline and 12-month follow up, the difference of the test scores between baseline and 12 month follow up was calculated.|Baseline, 12 month FU|||Scores on a scale||Standard Deviation|Mean
806123|NCT01009138|Secondary|Quality of Life (EQ-5D TTO Score)|The EuroQol Five Dimension Questionnaire (EQ-5D) was used to assess health-related quality of life (HRQOL). The EQ-5D assesses five dimensions of HRQOL using a 3-point scale. The item scores are weighted based on population data and used to calculate a standardised total score from 0 to 1 with higher scores indicating better HRQOL. Based on the measurement of HRQOL at baseline and 12-month follow up, the difference of the test scores between baseline and 12 month follow up was calculated.|Baseline,12 month FU|||Scores on a scale||Standard Deviation|Mean
806124|NCT01009138|Primary|Depressive Symptoms (CES-D Score)|The Center for Epidemiologic Studies Depression Scale (CES-D) was used to assess depressive symptoms. The CES-D assesses the frequency of 20 typical symptoms of depression during the previous week on a 4-point Likert scale. Summing of the item scores estimates the total score with a range between 0 and 60 and higher scores indicating more severe depressive mood. Based on the measurement of depressive symptoms at baseline and 12-month follow up, the difference of the test scores between baseline and 12 month follow up was calculated.|Baseline, 12 month FU|||Scores on a scale||Standard Deviation|Mean
806125|NCT01009203|Secondary|Overall Survival (OS)|The time from treatment initiation to death by any cause|3 years|||months||Full Range|Median
806126|NCT01009203|Secondary|Overall Response Rate (ORR)|Tumor response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI:) Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions. Overall response rate (ORR) is the sum of the percentages of patients achieving complete and partial responses|3 years|Participants evaluable for response||percentage of evaluable participants|||Number
806127|NCT01009203|Secondary|Toxicity Profile|Toxicities (i.e. Adverse Events) are evaluated prior to each treatment and during any clinical visit. Toxicity will be evaluated per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. The number of patients affected by adverse events of grade 3 or higher will be reported.|3 years|Participants who received t least one dose of on-study treatment||participants|||Number
806128|NCT01009203|Primary|Progression Free Survival (PFS)|The time from treatment initiation to disease progression or death by any cause. Progression is evaluated according to modified Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI): Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or unequivocal progression of existing non-target lesion, the appearance of new lesions, death due to disease without prior objective documentation of progression, or global deterioration in health status attributable to disease requiring a change in therapy without objective evidence of progression.|3 years|||Months||Full Range|Median
806130|NCT01009333|Secondary|Number of Voids Per Day|In a diary, subjects are asked clarify each void as 'urine', 'fecal' or 'both'. Either 'urine' or 'both' are counted as void for this analysis. The total number of voids was calculated per day.|three weeks|Data from 12 subjects who completed the study were included in the efficacy analysis; data from 1 subject was excluded because the subject was not compliant with the study protocol and was subsequently withdrawn from the study. Data from all 13 subjects were used for safety reporting.||Voids Per Day||Standard Deviation|Mean
806131|NCT01009333|Primary|Number of Urinary Incontinent Episodes Per Day|In a diary, subjects are asked to rate each urine leaking episode at 'None', 'Slight', 'Moderate' or 'Heavy'. The urinary incontinence was counted if there is any degree of leaking, from 'Slight' to 'Heavy'. The total number of urinary incontinence was calculated per day.|three weeks|Data from 12 subjects who completed the study were included in the efficacy analysis; data from 1 subject was excluded because the subject was not compliant with the study protocol and was subsequently withdrawn from the study. Data from all 13 subjects were used for safety reporting.||Episodes Per Day||Standard Deviation|Mean
806132|NCT01009346|Secondary|Clinical Activity of This Regimen Correlates With Markers of the EGF-R/mTOR Pathway in Tumor Tissue & the Role of FDG PET in Early Imaging.|Early termination due to toxicity with the RAD001 in combination with cetuximab and cisplatin.|1 year||||||
806133|NCT01009346|Secondary|Response Rate of RAD001 at MTD in Combination With Weekly Cetuximab & Cisplatin.|Early termination due to toxicity with the RAD001 in combination with cetuximab and cisplatin.|1 year||||||
806134|NCT01009346|Primary|Progression Free Survival (PFS) of RAD001 at MTD in Combination With Weekly Cetuximab and Cisplatin.|Early termination due to toxicity with the RAD001 in combination with cetuximab and cisplatin.|1 year|Only 5 patients received atleast one cycle of RAD001||months||95% Confidence Interval|Median
806135|NCT01009346|Primary|Maximum Tolerated Dose (MTD) of RAD001 in Combination With Cetuximab and Cisplatin.|Early termination due to toxicity with the RAD001 in combination with cetuximab and cisplatin.|Phase 1 was to enroll over 6 months||||||
806136|NCT01009463|Secondary|Change From Baseline in Trough FEV1 at Week 52 (Visit 11)|Pulmonary function was measured by forced expiratory volume in one second (FEV1). Trough FEV1 was defined as the 24-hour post-dose FEV1 assessment, which was obtained at each visit. Analysis performed using a repeated measures model with covariates of treatment, smoking status at Screening (stratum), baseline (pre-dose Day 1), centre grouping, Week, Week by Baseline, and Week by treatment interactions.|Baseline to Visit 11 (Week 52)/Early Withdrawal|ITT Population. Number of participants presented represent those with data available at the time point being presented, however all participants in the ITT population without missing covariate information and with at least one post Baseline measurement are included in the analysis.||Liters||Standard Error|Least Squares Mean
806137|NCT01009463|Secondary|Annual Rate of Exacerbations Requiring Systemic/Oral Corticosteroids Expressed as Least Square Mean|The annual rate of COPD exacerbations during the treatment period (per participant per year) that required systemic/oral corticosteroids was assessed. An exacerbation of COPD is defined as the worsening of two or more major symptoms (dyspnea, sputum volume, sputum purulence [color]) for at least two consecutive days; or the worsening of any one major symptom together with any one of the minor symptom (sore throat, cold, fever without other cause, increased cough, increased wheeze) for at least two consecutive days. The COPD exacerbation was categorized as mild, moderate, and severe by the investigator. Mild: worsening symptoms of COPD that were self-managed by the participant. Mild exacerbations were not associated with the use of oral corticosteroids or antibiotics. Moderate: worsening symptoms of COPD that required treatment with oral corticosteroids and/or antibiotics. Severe: worsening symptoms of COPD that required treatment with in-patient hospitalization.|From the start of the double blind study medication until Visit 11 (Week 52)/Early Withdrawal|Intent-to-Treat (ITT) Population: all par. randomized who received at least 1 dose of study drug and with available data for analysis. Analysis used a negative binomial regression model with covariates of trt, smoking status at Screening, Baseline pre-dose Day 1 % predicted FEV1 and region and with logarithm of time on trt as an offset variable.||Exacerbations per participant per year||95% Confidence Interval|Least Squares Mean
806138|NCT01009463|Secondary|Time to First Occurrence of Moderate or Severe COPD Exacerbation|Time to first occurrence analyzed by using a Cox proportional hazards model with covariates of treatment, smoking status at screening (stratum), baseline disease severity (pre-dose Day 1 % predicted FEV1) and centre grouping. An exacerbation of COPD is defined as the worsening of two or more major symptoms (dyspnea, sputum volume, sputum purulence [color]) for at least two consecutive days; or the worsening of any one major symptom together with any one of the minor symptoms (sore throat, cold, fever without other cause, increased cough, increased wheeze) for at least two consecutive days. A moderate exacerbation is defined as worsening symptoms of COPD that required treatment with oral corticosteroids and/or antibiotics. A severe exacerbation is defined as worsening symptoms of COPD that required treatment with in-patient hospitalization. The number of participants with a moderate or severe COPD exacerbation while on treatment are presented.|From the start of the double blind study medication until Visit 11 (Week 52)/Early Withdrawal|ITT Population||Participants|||Number
806139|NCT01009463|Primary|Annual Rate of Moderate and Severe COPD Exacerbations Expressed as Least Square Mean|The annual rate of moderate and severe chronic obstructive pulmonary disease (COPD) exacerbations during the treatment (trt) period (per participant [par.] per year) was assessed. An exacerbation of COPD, is defined as the worsening of two or more major symptoms (dyspnea, sputum volume, sputum purulence [color]) for at least two consecutive days; or the worsening of any one major symptom together with any one of the minor symptoms (sore throat, cold, fever without other cause, increased cough, increased wheeze) for at least two consecutive days. The COPD exacerbation was categorized as mild, moderate and severe by the investigator. Mild: worsening symptoms of COPD that were self-managed by the par. without the use of oral corticosteroids or antibiotics; Moderate: worsening symptoms of COPD that required treatment with oral corticosteroids and/or antibiotics; Severe: worsening symptoms of COPD that required treatment with in-patient hospitalization.|From the start of the double blinded study medication until Visit 11 (Week 52)/Early Withdrawal|Intent-to-Treat (ITT) Population: all par. randomized who received at least 1 dose of study drug and with available data for analysis. Analysis used a negative binomial regression model with covariates of trt, smoking status at Screening, Baseline pre-dose Day 1 % predicted FEV1 and region and with logarithm of time on trt as an offset variable.||Exacerbations per participant per year||95% Confidence Interval|Least Squares Mean
806144|NCT01009554|Secondary|Mean Stain Area for Lingual Sites at 8 Weeks|The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
806145|NCT01009554|Secondary|Mean Stain Area for Lingual Sites at 6 Weeks|The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
806146|NCT01009554|Secondary|Mean Stain Area for Lingual Sites at 4 Weeks|The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
806147|NCT01009554|Secondary|Mean Stain Intensity for Lingual Sites at 8 Weeks|The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
806213|NCT01012167|Secondary|Reactions to Partner|"Participant reported responses after Brief Role Play. The Reactions to Partner item was calculated by totaling responses to 7 scales. Each scale score ranges from 1-5, which 1 being completely agree and 5 being completely disagree. The minimum score for this measure is 7 and the maximum score is 35. Higher responses indicate a more negative reaction to their role play partner."|Treatment Week 0 and Week 6|Role play data was collected at baseline and week 6, so only those participants who completed the role play at week 6 appear in these outcome analyses.||units on a scale||Standard Deviation|Mean
806148|NCT01009554|Secondary|Mean Stain Intensity for Lingual Sites at 6 Weeks|The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
806149|NCT01009554|Secondary|Mean Stain Intensity for Lingual Sites at 4 Weeks|The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
806150|NCT01009554|Secondary|Mean Stain Score for Lingual Sites at 8 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
806151|NCT01009554|Secondary|Mean Stain Score for Lingual Sites at 6 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
806152|NCT01009554|Secondary|Mean Stain Score for Lingual Sites at 4 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
806153|NCT01009554|Secondary|Mean Stain Area for Facial Sites at 8 Weeks|The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
806214|NCT01012167|Secondary|Positive and Negative Affect Schedule (PANAS) - Positive|"Participant reported responses after Brief Role Play rating how they felt during the role plays. Participants rated 12 positive affect items on a scale of 1-5, with 1 being very slightly or not at all and 5 being extremely. The minimum score for this measure is 12 and the maximum score is 60. Higher scores indicate a higher rate of positive affect during the role plays."|Treatment Week 0 and Week 6|Role play data was collected at baseline and week 6, so only those participants who completed the role play at week 6 appear in these outcome analyses.||units on a scale||Standard Deviation|Mean
806154|NCT01009554|Secondary|Mean Stain Area for Facial Sites at 6 Weeks|The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
806155|NCT01009554|Secondary|Mean Stain Area for Facial Sites at 4 Weeks|The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
806156|NCT01009554|Secondary|Mean Stain Intensity for Facial Sites at 8 Weeks|The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
806157|NCT01009554|Secondary|Mean Stain Intensity for Facial Sites at 6 Weeks|The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
806158|NCT01009554|Secondary|Mean Stain Intensity for Facial Sites at 4 Weeks|The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
806159|NCT01009554|Secondary|Mean Stain Score for Facial Sites at 8 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
806160|NCT01009554|Secondary|Mean Stain Score for Facial Sites at 6 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
806161|NCT01009554|Secondary|Mean Stain Score for Facial Sites at 4 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
806162|NCT01009554|Secondary|Mean Stain Area for Body Sites at 8 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The body regions were scored for area according to the following criteria. Stain area for the body of the tooth was scored as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
806163|NCT01009554|Secondary|Mean Stain Area for Body Sites at 6 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The body regions were scored for area according to the following criteria. Stain area for the body of the tooth was scored as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
806164|NCT01009554|Secondary|Mean Stain Area for Body Sites at 4 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The body regions were scored for area according to the following criteria. Stain area for the body of the tooth was scored as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
806165|NCT01009554|Secondary|Mean Stain Intensity for Body Sites at 8 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The body regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The body regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
806166|NCT01009554|Secondary|Mean Stain Intensity for Body Sites at 6 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The body regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The body regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
806167|NCT01009554|Secondary|Mean Stain Intensity for Body Sites at 4 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The body regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The body regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
806215|NCT01012167|Secondary|Positive and Negative Affect Schedule (PANAS) - Negative|"Participant reported responses after Brief Role Play rating how they felt during the role plays. Participants rated 12 negative affect items on a scale of 1-5, with 1 being very slightly or not at all and 5 being extremely. The minimum score for this measure is 12 and the maximum score is 60. Higher scores indicate a higher rate of negative affect during the role plays."|Treatment Week 0 and Week 6|Role play data was collected at baseline and week 6, so only those participants who completed the role play at week 6 appear in these outcome analyses.||units on a scale||Standard Deviation|Mean
806168|NCT01009554|Secondary|Mean Stain Score for Body Sites at 8 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for the body of the tooth was scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
806169|NCT01009554|Secondary|Mean Stain Score for Body Sites at 6 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for the body of the tooth was scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
806170|NCT01009554|Secondary|Mean Stain Score for Body Sites at 4 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for the body of the tooth was scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
806171|NCT01009554|Secondary|Mean Stain Area for Gingival Sites at 8 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The gingival regions were scored for area according to the following criteria. Stain area for gingival regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area.|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
806172|NCT01009554|Secondary|Mean Stain Area for Gingival Sites at 6 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The gingival regions were scored for area according to the following criteria. Stain area for gingival regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area.|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
806173|NCT01009554|Secondary|Mean Stain Area for Gingival Sites at 4 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The gingival regions were scored for area according to the following criteria. Stain area for gingival regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area.|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
806174|NCT01009554|Secondary|Mean Stain Intensity for Gingival Sites at 8 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The gingival regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The gingival regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
806182|NCT01009554|Secondary|Mean Stain Area for Interproximal (Mesial and Distal) Sites at 4 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The interproximal (mesial and distal) regions were scored for area according to the following criteria. Stain area for mesial and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area.|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
806175|NCT01009554|Secondary|Mean Stain Intensity for Gingival Sites at 6 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The gingival regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The gingival regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
806176|NCT01009554|Secondary|Mean Stain Intensity for Gingival Sites at 4 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The gingival regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The gingival regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
806177|NCT01009554|Secondary|Mean Stain Score for Gingival Sites at 8 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for gingival regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
806178|NCT01009554|Secondary|Mean Stain Score for Gingival Sites at 6 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for gingival regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
806179|NCT01009554|Secondary|Mean Stain Score for Gingival Sites at 4 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for gingival regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
806180|NCT01009554|Secondary|Mean Stain Area for Interproximal (Mesial and Distal) Sites at 8 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The interproximal (mesial and distal) regions were scored for area according to the following criteria. Stain area for mesial and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area.|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
806181|NCT01009554|Secondary|Mean Stain Area for Interproximal (Mesial and Distal) Sites at 6 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The interproximal (mesial and distal) regions were scored for area according to the following criteria. Stain area for mesial and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area.|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
810307|NCT01050673|Primary|Difference in Time to Closure Between Wounds Surgically Excised With VERSAJET™ Hydrosurgery System and Those Surgically Excised Using Conventional Operating Room Techniques.||28 days plus 6 week follow-up|||Time (minutes)||Standard Deviation|Median
806183|NCT01009554|Secondary|Mean Stain Intensity For Interproximal (Mesial and Distal) Sites at 8 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The interproximal (mesial and distal) regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
806184|NCT01009554|Secondary|Mean Stain Intensity For Interproximal (Mesial and Distal) Sites at 6 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The interproximal (mesial and distal) regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
806185|NCT01009554|Secondary|Mean Stain Intensity For Interproximal (Mesial and Distal) Sites at 4 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The interproximal (mesial and distal) regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
806186|NCT01009554|Secondary|Mean Stain Score for Interproximal (Mesial and Distal) Sites at 8 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for mesial and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
806187|NCT01009554|Secondary|Mean Stain Score for Interproximal (Mesial and Distal) Sites at 6 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for mesial and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
806188|NCT01009554|Secondary|Mean Stain Score for Interproximal (Mesial and Distal) Sites at 4 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for mesial and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
806189|NCT01009554|Secondary|Mean Stain Area Over All Tooth Sites at 8 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
810308|NCT01050764|Secondary|Serious Infections|Serious infections are reported as the number of participants experienced serious infections.|1 year|Population of participants that received HSCT and T-reg plus T-con||Participants|||Count of Participants
806190|NCT01009554|Secondary|Mean Stain Area Over All Tooth Sites at 6 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
806191|NCT01009554|Secondary|Mean Stain Area Over All Tooth Sites at 4 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
806192|NCT01009554|Secondary|Mean Stain Intensity Over All Tooth Sites at 8 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
806193|NCT01009554|Secondary|Mean Stain Intensity Over All Tooth Sites at 6 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
806194|NCT01009554|Secondary|Mean Stain Intensity Over All Tooth Sites at 4 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
806195|NCT01009554|Secondary|Mean Stain Score Over All Tooth Sites at 8 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
806203|NCT01009554|Secondary|Change in Tooth Color as Represented by ΔL at 4 Weeks Post Baseline From the CIElab Assessment|The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The change in the individual L* color parameter was calculated. The ΔL was calculated per tooth and then averaged over the teeth for a participant.|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
806240|NCT01012167|Secondary|Side Effect Checklist (SEC) - Insomnia|"Percentage of participants with new onset or worsening compared to baseline of Insomnia rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.||percentage of participants|||Number
806196|NCT01009554|Secondary|Mean Stain Score Over All Tooth Sites at 6 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
806197|NCT01009554|Secondary|Mean Stain Score Over All Tooth Sites at 4 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
806198|NCT01009554|Secondary|Change in Tooth Color as Represented by Δb at 8 Weeks Post Baseline From the CIElab Assessment|The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The change in the individual b* color parameter was calculated. The Δb was calculated per tooth and then averaged over the teeth for a participant.|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
806199|NCT01009554|Secondary|Change in Tooth Color as Represented by Δb at 6 Weeks Post Baseline From the CIElab Assessment|The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The change in the individual b* color parameter was calculated. The Δb was calculated per tooth and then averaged over the teeth for a participant.|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
806200|NCT01009554|Secondary|Change in Tooth Color as Represented by Δb at 4 Weeks Post Baseline From the CIElab Assessment|The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The change in the individual b* color parameter was calculated. The Δb was calculated per tooth and then averaged over the teeth for a participant.|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
806201|NCT01009554|Secondary|Change in Tooth Color as Represented by ΔL at 8 Weeks Post Baseline From the CIElab Assessment|The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The change in the individual L* color parameter was calculated. The ΔL was calculated per tooth and then averaged over the teeth for a participant.|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
806202|NCT01009554|Secondary|Change in Tooth Color as Represented by ΔL at 6 Weeks Post Baseline From the CIElab Assessment|The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The change in the individual L* color parameter was calculated. The ΔL was calculated per tooth and then averaged over the teeth for a participant.|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
806216|NCT01012167|Secondary|Neurocognitive Assessment Battery (MCCB) - Working Memory|MCCB Working Memory domain score by week calculated from the Wechsler Memory Scale, 3rd ed., spatial span subtest. The domain score scale is 20-80, with higher scores indicating a better outcome.|Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).|Cognitive data was collected at baseline and week 6, so only those participants who got to week 6 appear in cognitive outcome analyses.||units on a scale||Standard Deviation|Mean
806204|NCT01009554|Secondary|Change in Tooth Color as Represented by ΔE at 6 Weeks Post Baseline From the CIElab Assessment|The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The changes in the individual L*, a*, and b* color parameters were calculated to determine quantitatively the improvements in tooth lightness, redness, and yellowness, respectively. An overall change in tooth color was calculated using the CIE color equation ΔE = [(ΔL*)^2 + (Δa*)^2 + (Δb*)^2]^1/2. The ΔE was calculated per tooth and then averaged over the teeth for a participant.|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
806205|NCT01009554|Secondary|Change in Tooth Color as Represented by ΔE at 4 Weeks Post Baseline From the CIElab Assessment|The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The changes in the individual L*, a*, and b* color parameters were calculated to determine quantitatively the improvements in tooth lightness, redness, and yellowness, respectively. An overall change in tooth color was calculated using the CIE color equation ΔE = [(ΔL*)^2 + (Δa*)^2 + (Δb*)^2]^1/2. The ΔE was calculated per tooth and then averaged over the teeth for a participant.|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
806206|NCT01009554|Primary|Oral Tissue Tolerance|Oral tissue tolerance was assessed by oral tissue adverse events for which the relationship to treatment was considered as possible, probable, or very likely. If the relationship to treatment was missing, the adverse event was categorized as a treatment-related adverse event.|through 8 weeks|Analysis was based on the Safety Analysis Set, defined as all participants who used at least one dose of investigational product.||percentage of participants|||Number
806207|NCT01009554|Primary|Change in Tooth Color as Represented by ΔE at 8 Weeks Post Baseline From the CIElab Assessment|The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The changes in the individual L*, a*, and b* color parameters were calculated to determine quantitatively the improvements in tooth lightness, redness, and yellowness, respectively. An overall change in tooth color was calculated using the CIE color equation ΔE = [(ΔL*)^2 + (Δa*)^2 + (Δb*)^2]^1/2. The ΔE was calculated per tooth and then averaged over the teeth for a participant.|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
806208|NCT01009580|Secondary|Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 a.m.|Week 0 to Week 26 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||Episodes/100 years of patient exposure|||Number
806209|NCT01009580|Secondary|Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 26 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||Episodes/100 years of patient exposure|||Number
806210|NCT01009580|Secondary|Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)|Mean of SMPG after 26 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast.|Week 26|The full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). One subject was randomised in error, hence removed from the FAS. For 24 subjects all 9-point SMPG values were missing.||mmol/L||Standard Deviation|Mean
806211|NCT01009580|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Change from baseline in HbA1c after 26 weeks of treatment.|Week 0, Week 26|The full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). One subject was randomised in error, hence removed from the FAS.||percentage of glycosylated haemoglobin||Standard Deviation|Mean
806212|NCT01012167|Secondary|Willingness to Interact|"Participant reported responses after Brief Role Play. The Willingness to Interact item calculated by totaling scores from items 1-6. Each score ranges from 1-5, with 1 being definitely willing and 5 being definitely unwilling. The minimum score for this measure is 6 and the maximum score is 30. Lower scores indicate more willingness to interact with their role play partner again in the future."|Treatment Week 0 and Week 6|Role play data was collected at baseline and week 6, so only those participants who completed the role play at week 6 appear in these outcome analyses.||units on a scale||Standard Deviation|Mean
806217|NCT01012167|Secondary|Neurocognitive Assessment Battery (MCCB) - Visual Learning|MCCB Visual Learning domain score by week calculated from the Brief Visuospatial Memory Test—Revised. The domain score scale is 20-80, with higher scores indicating a better outcome.|Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).|Cognitive data was collected at baseline and week 6, so only those participants who got to week 6 appear in cognitive outcome analyses.||units on a scale||Standard Deviation|Mean
806218|NCT01012167|Secondary|Neurocognitive Assessment Battery (MCCB) - Verbal Learning|MCCB Verbal Learning domain score by week calculated from the Hopkins Verbal Learning Test—Revised, immediate recall (three learning trials only). The domain score scale is 20-80, with higher scores indicating a better outcome.|Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).|Cognitive data was collected at baseline and week 6, so only those participants who got to week 6 appear in cognitive outcome analyses.||units on a scale||Standard Deviation|Mean
806219|NCT01012167|Secondary|Neurocognitive Assessment Battery (MCCB) - Social Cognition|MCCB Social Cognition domain score by week calculated from the Mayer-Salovey-Caruso Emotional Intelligence Test- managing emotions branch. The domain score scale is 20-80, with higher scores indicating a better outcome.|Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).|Cognitive data was collected at baseline and week 6, so only those participants who got to week 6 appear in cognitive outcome analyses.||units on a scale||Standard Deviation|Mean
806220|NCT01012167|Secondary|Neurocognitive Assessment Battery (MCCB) - Reasoning/Problem Solving|MCCB Reasoning/Problem Solving domain score by week calculated from the Neuropsychological Assessment Battery- mazes subtest. The domain score scale is 20-80, with higher scores indicating a better outcome.|Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).|Cognitive data was collected at baseline and week 6, so only those participants who got to week 6 appear in cognitive outcome analyses.||units on a scale||Standard Deviation|Mean
806221|NCT01012167|Secondary|Neurocognitive Assessment Battery (MCCB) - Processing Speed|MCCB Processing Speed domain score by week calculated from the Trail Making Test- Part A, Brief Assessment of Cognition in Schizophrenia- symbol coding subtest, and the Category fluency test- animal naming. The domain score scale is 20-80, with higher scores indicating a better outcome.|Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).|Cognitive data was collected at baseline and week 6, so only those participants who got to week 6 appear in cognitive outcome analyses.||units on a scale||Standard Deviation|Mean
806222|NCT01012167|Secondary|Neurocognitive Assessment Battery (MCCB) - Attention Vigilance|MCCB Attention Vigilance domain score by week calculated from the Continuous Performance Test, Identical Pairs version. The domain score scale is 20-80, with higher scores indicating a better outcome.|Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).|Cognitive data was collected at baseline and week 6, so only those participants who got to week 6 appear in cognitive outcome analyses.||units on a scale||Standard Deviation|Mean
806223|NCT01012167|Secondary|Neurocognitive Assessment Battery (MCCB) - Composite Score|MCCB Composite Score by Week ranging from -10-100 with a higher score indicating a better outcome.|Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).|Cognitive data was collected at baseline and week 6, so only those participants who got to week 6 appear in cognitive outcome analyses.||units on a scale||Standard Deviation|Mean
806224|NCT01012167|Secondary|Side Effect Checklist (SEC) - Wheezing|"Percentage of participants with new onset or worsening compared to baseline of Wheezing rating on the SEC, by Treatment Group."|Weekly for 6 weeks|"Safety data for 56 participants exposed to study treatment minus 6 participants with missing wheezing data."||percentage of participants|||Number
806225|NCT01012167|Secondary|Side Effect Checklist (SEC) - Weight Loss|"Percentage of participants with new onset or worsening compared to baseline of Weight Loss rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.||percentage of participants|||Number
806226|NCT01012167|Secondary|Side Effect Checklist (SEC) - Vomiting|"Percentage of participants with new onset or worsening compared to baseline of Vomiting rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.||percentage of participants|||Number
806227|NCT01012167|Secondary|Side Effect Checklist (SEC) - Uterine Contractions|"Percentage of participants with new onset or worsening compared to baseline of Uterine Contractions rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Female participants||percentage of participants|||Number
806228|NCT01012167|Secondary|Side Effect Checklist (SEC) - Urticaria|"Percentage of participants with new onset or worsening compared to baseline of Urticaria rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.||percentage of participants|||Number
806229|NCT01012167|Secondary|Side Effect Checklist (SEC) - Tremor|"Percentage of participants with new onset or worsening compared to baseline of Tremor rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.||percentage of participants|||Number
806230|NCT01012167|Secondary|Side Effect Checklist (SEC) - Tinnitus|"Percentage of participants with new onset or worsening compared to baseline of Tinnitus rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.||percentage of participants|||Number
806231|NCT01012167|Secondary|Side Effect Checklist (SEC) - Stiffness|"Percentage of participants with new onset or worsening compared to baseline of Stiffness rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.||percentage of participants|||Number
806232|NCT01012167|Secondary|Side Effect Checklist (SEC) - Sore Throat|"Percentage of participants with new onset or worsening compared to baseline of Sore Throat rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.||percentage of participants|||Number
806233|NCT01012167|Secondary|Side Effect Checklist (SEC) - Sedation|"Percentage of participants with new onset or worsening compared to baseline of Sedation rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.||percentage of participants|||Number
806234|NCT01012167|Secondary|Side Effect Checklist (SEC) - Restlessness|"Percentage of participants with new onset or worsening compared to baseline of Restlessness rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.||percentage of participants|||Number
806235|NCT01012167|Secondary|Side Effect Checklist (SEC) - Rash|"Percentage of participants with new onset or worsening compared to baseline of Rash rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.||percentage of participants|||Number
806236|NCT01012167|Secondary|Side Effect Checklist (SEC) - Nausea|"Percentage of participants with new onset or worsening compared to baseline of Nausea rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.||percentage of participants|||Number
806242|NCT01012167|Secondary|Side Effect Checklist (SEC) - Hyperhydrosis|"Percentage of participants with new onset or worsening compared to baseline of Hyperhydrosis rating on the SEC, by Treatment Group."|Weekly for 6 weeks|"Safety data for 56 participants exposed to study treatment minus 6 participants who had missing Hyperhydrosis data."||percentage of participants|||Number
806243|NCT01012167|Secondary|Side Effect Checklist (SEC) - Headache|"Percentage of participants with new onset or worsening compared to baseline of Headache rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.||percentage of participants|||Number
806244|NCT01012167|Secondary|Side Effect Checklist (SEC) - Fever|"Percentage of participants with new onset or worsening compared to baseline of Fever rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.||percentage of participants|||Number
806245|NCT01012167|Secondary|Side Effect Checklist (SEC) - Excessive Tearing of the Eye|"Percentage of participants with new onset or worsening compared to baseline of Excessive Tearing of the Eye rating on the SEC, by Treatment Group."|Weekly for 6 weeks|"Safety data for 56 participants exposed to study treatment minus 6 participants who had missing excessive tearing of the eye data."||percentage of participants|||Number
806246|NCT01012167|Secondary|Side Effect Checklist (SEC) - Enuresis|"Percentage of participants with new onset or worsening compared to baseline of Enuresis rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.||percentage of participants|||Number
806247|NCT01012167|Secondary|Side Effect Checklist (SEC) - Dry Mouth|"Percentage of participants with new onset or worsening compared to baseline of Dry Mouth rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.||percentage of participants|||Number
806248|NCT01012167|Secondary|Side Effect Checklist (SEC) - Dry Eye|"Percentage of participants with new onset or worsening compared to baseline of Dry Eye rating on the SEC, by Treatment Group."|Weekly for 6 weeks|"Safety data for 56 participants exposed to study treatment minus 6 participants who had missing dry eye data."||percentage of participants|||Number
806249|NCT01012167|Secondary|Side Effect Checklist (SEC) - Dizziness|"Percentage of participants with new onset or worsening compared to baseline of Dizziness rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.||percentage of participants|||Number
806250|NCT01012167|Secondary|Side Effect Checklist (SEC) - Diarrhea|"Percentage of participants with new onset or worsening compared to baseline of Diarrhea rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.||percentage of participants|||Number
806251|NCT01012167|Secondary|Side Effect Checklist (SEC) - Constipation|"Percentage of participants with new onset or worsening compared to baseline of Constipation rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.||percentage of participants|||Number
806252|NCT01012167|Secondary|Side Effect Checklist (SEC) - Bruising Easily|"Percentage of participants with new onset or worsening compared to baseline of Bruising Easily rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.||percentage of participants|||Number
806253|NCT01012167|Secondary|Side Effect Checklist (SEC) - Anorexia|"Percentage of participants with new onset or worsening compared to baseline of Anorexia rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.||percentage of participants|||Number
806254|NCT01012167|Secondary|Side Effect Checklist (SEC) - Abdominal Pain|"Percentage of participants with new onset or worsening compared to baseline of Abdominal Pain rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.||percentage of participants|||Number
806255|NCT01012167|Secondary|Laboratory Measures - BUN|BUN blood level by treatment group and visit.|Once during evaluation and once at the end of 6 weeks of study treatment|Available participant data for Evaluation and Week 6.||mg/dL||Standard Deviation|Mean
806256|NCT01012167|Secondary|Laboratory Measures - Protein|Protein blood level by treatment group and visit.|Once during evaluation and once at the end of 6 weeks of study treatment|Available participant data for Evaluation and Week 6.||g/dL||Standard Deviation|Mean
806257|NCT01012167|Secondary|Laboratory Measures - Bilirubin|Bilirubin blood level by treatment group and visit.|Once during evaluation and once at the end of 6 weeks of study treatment|Available participant data for Evaluation and Week 6.||mg/dL||Standard Deviation|Mean
806258|NCT01012167|Secondary|Laboratory Measures - A/G Ratio|Albumin to Globulin (A/G) ratio in the blood by treatment group and visit.|Once during evaluation and once at the end of 6 weeks of study treatment|Available participant date for Evaluation and Week 6.||g/dL||Standard Deviation|Mean
806259|NCT01012167|Secondary|Laboratory Measures - Globulin|Globulin blood levels by treatment group and visit.|Once during evaluation and once at the end of 6 weeks of study treatment|Available participant lab data for Evaluation and Week 6.||g/dL||Standard Deviation|Mean
806260|NCT01012167|Secondary|Laboratory Measures - Albumin|Albumin blood levels by treatment group and visit.|Once during evaluation and once at the end of 6 weeks of study treatment|Available participant lab data for Evaluation and Week 6.||g/dL||Standard Deviation|Mean
806261|NCT01012167|Secondary|Laboratory Measures - Glucose|Glucose blood levels by treatment group and visit.|Once during evaluation and once at the end of 6 weeks of study treatment|Available participant lab data for Evaluation and Week 6.||mg/dL||Standard Deviation|Mean
806262|NCT01012167|Secondary|Laboratory Measures - VLDL|Very low density lipoprotein (VLDL) blood levels by treatment group and visit.|Once during evaluation and once at the end of 6 weeks of study treatment|Available participant lab data for Evaluation and Week 6.||mg/dL||Standard Deviation|Mean
806263|NCT01012167|Secondary|Laboratory Measures - Triglycerides|Triglyceride blood levels by treatment group and visit.|Once during evaluation and once at the end of 6 weeks of study treatment|Available participant lab data for Evaluation and Week 6.||mg/dL||Standard Deviation|Mean
806264|NCT01012167|Secondary|Laboratory Measures - LDL|Low-density lipoprotein (LDL) blood levels by treatment group and visit.|Once during evaluation and once at the end of 6 weeks of study treatment|Available participant lab data for Evaluation and Week 6.||mg/dL||Standard Deviation|Mean
806265|NCT01012167|Secondary|Laboratory Measures - HDL|High-density lipoprotein (HDL) blood levels by treatment group and visit.|Once during evaluation and once at the end of 6 weeks of study treatment|Available participant data from Evaluation and Week 6.||mg/dL||Standard Deviation|Mean
806273|NCT01012167|Secondary|Laboratory Measures - AST/SGOT|Aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT) blood levels by treatment group and visit.|Once during evaluation and once at the end of 6 weeks of study treatment|Available participant lab data at Evaluation and Week 6.||U/L||Standard Deviation|Mean
806274|NCT01012167|Secondary|Laboratory Measures - ALT/SGPT|Alanine transaminase/serum glutamic-pyruvic transaminase (ALT/SGPT) blood levels by treatment group and visit.|Once during evaluation and once at the end of 6 weeks of study treatment|Available participant lab data at Evaluation and Week 6.||U/L||Standard Deviation|Mean
806275|NCT01012167|Secondary|Blood Oxytocin Levels|Blood Oxytocin Levels by Treatment and Visit|Treatment Week 0 and Week 6|Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected.||pg/mL||Standard Deviation|Mean
806276|NCT01012167|Secondary|Barnes Akathisia Scale (BAS) - Global Score|"For each subject, the largest increase from baseline in the global akathisia score at any visit during follow-up was calculated. The global akathisia score ranges from 0=Absent to 5=Severe Akathisia. Higher scores indicate a more severe global rating of akathisia."|Treatment Week 0 and Week 6|50 participants who completed the trial.||percentage of participants|||Number
806277|NCT01012167|Secondary|Electrocardiogram (EKG)|Mean corrected QT interval (QTc) by study week and treatment.|Once during Evaluation and once at Treatment Week 6|50 participants who completed the trial.||QTc||Standard Deviation|Mean
806278|NCT01012167|Secondary|Abnormal Involuntary Movement Scale (AIMS)|"AIMS Total Score: Frequencies of Maximum Within- Participant Increases (worsening) from Baseline by Treatment Group. Total score calculated by adding scores from scales #1-#10. Each scale ranges from 0=None to 4=Severe. The minimum total AIMS score is 0 and the maximum score is 40. Higher scores indicate a more severe abnormal involuntary movement rating."|Treatment Week 0 and Week 6|50 participants who completed the trial.||percentage of participants|||Number
806279|NCT01012167|Secondary|Simpson-Angus Scale (SAS)|"SAS total score for extrapyramidal side effects: Frequencies of greatest within-participant increase (worsening) from pre-treatment baseline, by treatment group. Total scores calculated by adding scores from scales #1-#11. Each scale ranges from 0=None/Normal to 4=Extreme/Severe. The minimum total score is 0 and the maximum score is 44. Higher scores indicate a more severe extrapyramidal side effect rating."|Baseline, week 3, and week 6|Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected. Participants had to complete at least two weeks follow-up to be included in the symptom analysis.||percentage of participants|||Number
806280|NCT01012167|Secondary|Vital Signs - Pulse|Mean sitting pulse (bpm) by treatment and follow-up week|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.||bpm||Standard Deviation|Mean
806281|NCT01012167|Secondary|Vital Signs - Weight|Mean weight (kg) by treatment and follow-up week|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.||kg||Standard Deviation|Mean
806282|NCT01012167|Secondary|Vital Signs - Systolic Blood Pressure|Mean systolic blood pressure by treatment and follow-up week|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.||mm-Hg||Standard Deviation|Mean
806283|NCT01012167|Secondary|Vital Signs - Diastolic Blood Pressure|Mean diastolic blood pressure by treatment and follow-up week|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.||mm-Hg||Standard Deviation|Mean
806284|NCT01012167|Secondary|Arizona Sexual Experience Questionnaire (ASEX) Male|"Mean ASEX total scores by treatment and week for male participants. Total scores are calculated by adding scores for scales #1-#5. Total scores are calculated by adding scores for scales #1-#5. Each scale ranges from 1=Easily/Extremely to 6=Never/None. The minimum total ASEX score is 5 and the maximum score is 30. Lower scores indicate more positive sexual experiences."|Once during evaluation and once at the end of 6 weeks of study treatment|Male participants who completed at least two weeks follow-up.||units on a scale||Standard Deviation|Mean
806285|NCT01012167|Secondary|Arizona Sexual Experience Questionnaire (ASEX) Female|"Mean ASEX total scores by treatment and week for female participants. Total scores are calculated by adding scores for scales #1-#5. Each scale ranges from 1=Easily/Extremely to 6=Never/None. The minimum total ASEX score is 5 and the maximum score is 30. Lower scores indicate more positive sexual experiences."|Once during evaluation and once at the end of 6 weeks of study treatment|Female participants who completed at least two weeks follow-up.||units on a scale||Standard Deviation|Mean
806286|NCT01012167|Secondary|Calgary Depression Scale (CDS) - Total Score|"Total score calculated by adding scores for scales #1-#9. Each scale ranges from 0=Absent to 3=Severe. The minimum total CDS score is 0 and the maximum total CDS score is 27. A higher score indicates a more severe depression rating."|Every other week for 6 weeks|Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected. Participants had to complete at least two weeks follow-up to be included in the symptom analysis.||units on a scale||Standard Deviation|Mean
806287|NCT01012167|Secondary|Brief Psychiatric Rating Scale (BPRS) - Psychosis Score|"The psychosis score is calculated by adding the scores for scales #4 Conceptual Disorganization, #11 Suspiciousness, #12 Hallucinatory Behavior, and #15 Unusual Thought Content. Each scale ranges from 1=Not Present to 7=Very Severe. The minimum psychosis score is 4 and the maximum psychosis score is 28. A higher score indicates a more severe psychosis rating."|Every other week for 6 weeks|Safety data available for the 56 participants exposed to study treatment.||units on a scale||Standard Deviation|Mean
806288|NCT01012167|Secondary|Brief Psychiatric Rating Scale (BPRS) - Total Score|"The total BPRS score is calculated by adding the scores for scales #1-#18. Each scale ranges from 1=Not Present to 7=Very Severe. Total scores range from a minimum score of 18 to a maximum score of 126. A higher total score indicates a more severe psychiatric symptom rating."|Every other week for 6 weeks|Safety data available for 56 participants exposed to study treatment.||units on a scale||Standard Deviation|Mean
806289|NCT01012167|Secondary|Scale for the Assessment of Negative Symptoms (SANS) - Blunted Affect|Mean score by treatment and week. Scores range from 0-5, with higher scores indicating a worse outcome.|Every other week for 6 weeks|Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected. Participants had to complete at least two weeks follow-up to be included in the symptom analysis.||units on a scale||Standard Deviation|Mean
806290|NCT01012167|Secondary|Scale for the Assessment of Negative Symptoms (SANS) - Alogia|Mean score by treatment and week. Scores range from 0-5, with higher scores indicating a worse outcome.|Every other week for 6 weeks|Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected. Participants had to complete at least two weeks follow-up to be included in the symptom analysis.||units on a scale||Standard Deviation|Mean
806291|NCT01012167|Secondary|Scale for the Assessment of Negative Symptoms (SANS) - Anhedonia|Mean score by treatment and week. Scores range from 0-5, with higher scores indicating a worse outcome.|Every other week for 6 weeks|Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected. Participants had to complete at least two weeks follow-up to be included in the symptom analysis.||units on a scale||Standard Deviation|Mean
806292|NCT01012167|Secondary|Scale for the Assessment of Negative Symptoms (SANS) - Avolition|Mean score by treatment and week. Scores range from 0-5, with higher scores indicating a worse outcome.|Every other week for 6 weeks|Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected. Participants had to complete at least two weeks follow-up to be included in the symptom analysis.||units on a scale||Standard Deviation|Mean
806293|NCT01012167|Primary|Mean Z-Scores for Composite Cognitive Primary Outcome* by Treatment Group and Week|* Composite Cognitive Primary Outcome = mean of z-scores from the Brief Assessment of Cognition in Schizophrenia (BACS) Symbol Digit test, the Hopkins Verbal Learning Test (HVLT), and the Rapid Visual Information Processing test (RVIP). Z-scores for each test were calculated as Z = (individual patient score - pooled baseline mean)/(pooled baseline standard deviation). Higher values of the composite score represent a better outcome.|Treatment Week 0 and Week 6|Five subjects were unable to handle the demands of the Rapid Visual Information Processing (RVIP) test, part of the composite primary outcome measure, and did not provide valid data.||units on a scale||Standard Deviation|Mean
806294|NCT01012167|Primary|Scale for the Assessment of Negative Symptoms (SANS) Total Score|Mean SANS Total Score by Treatment and Week. SANS total score range = 0-85. Higher scores indicate more severe negative symptoms.|Every other week for 6 weeks|Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected. Participants had to complete at least two weeks follow-up to be included in the symptom analysis.||units on a scale||Standard Deviation|Mean
806295|NCT01012219|Primary|Cutaneous Bleeding Time (BT)|"Cutaneous bleeding Time (BT) on Day 8 after daily administration of laropiprant with aspirin and clopidogrel for 7 days versus BT on Day 8 after daily administration of placebo with aspirin and clopidogrel for 7 days.
The model used included treatment, period and sequence as fixed effect variables and subjects as the random effect variable.
Period 3 was not analyzed as bleeding time was not an objective for this part of the study."|Day 8|Due to technical reasons, bleeding time was zero for some participants; they were considered to be missing data. Therefore, these observations were excluded from the analysis.||Seconds||95% Confidence Interval|Least Squares Mean
806296|NCT01012245|Secondary|Changes to the Color of the Iris During Xalatan® or Xalacom® Treatment|Number of subjects with documented change to the color of the iris during treatment with Xalatan® or Xalacom®.|Baseline up to 3 years|Xalatan® treatment group (subjects with Xalatan® (latanoprost) monotherapy at baseline visit) and Xalacom® treatment group (latanoprost + timolol maleate) therapy at baseline visit. During the course of the study the data structure (scaling of color) was changed in a way that change in iris color was no longer evaluable; data not summarized.||participants|||Number
806297|NCT01012245|Secondary|Reasons for Discontinuation From Study|Number of subjects per reason for discontinuation from the study. More than one reason for discontinuation is possible per patient. Discontinuation analysis was performed independent of the duration of any individual subject's time on study.|January 2000 through December 2008|Subjects from the All subjects group population who discontinued the study.||participants|||Number
806298|NCT01012245|Secondary|Investigator Assessment of Tolerability of Xalatan® Treatment|Number of subjects for the Investigator's assessment of subjects tolerability of Xalatan® treatment categorized as excellent, very good, good, moderate, sufficient, or insufficient. The occurrence of adverse events (a side effect that may not have any causal relationship to study treatment) was documented as tolerability data.|Baseline up to 3 years|Xalatan® treatment group only (subjects with Xalatan monotherapy at baseline visit).||participants|||Number
806299|NCT01012245|Secondary|Reasons for Changes in Glaucoma Therapy|Number of subjects for each reason for change of therapy; there may be more than one reason possible per patient. Reasons for changes in glaucoma therapy was reported from January 2000 through December 2008 independent of the duration of any individual subject's time on study.|January 2000 through December 2008|"Subjects from the all subjects group that changed therapy through the duration of the study; subjects who changed from or changed to other therapy (Other Medication) were not included in this analysis; not summarized by subgroups."||participants|||Number
806300|NCT01012245|Secondary|Subject Self-care: Application of Eye Drops|Number of subjects per level of ability for application (administration) of eye drops categorized as without the help of nursing staff (apply without help) and with the help of nursing staff (apply with help).|Baseline, 1 year, 2 years, and 3 years|All subjects group; not summarized by subgroups||participants|||Number
806301|NCT01012245|Secondary|Visual Impairment Due to Glaucoma|Number of subjects per level of visual impairment categorized as not at all (no impairment), a little bit, moderate, severe, and very severe (very severe impairment).|Baseline, 1 year, 2 years, and 3 years|All subjects group; not summarized by subgroups||participants|||Number
806302|NCT01012245|Secondary|Visual Acuity (Visus)|Number of subjects with visual acuity evaluations: amaurosis (partial or total loss of sight); hand movements (able to detect gross object and motion perception without detailed discrimination); finger count (able to count fingers at a given distance); visual acuity scale: range 0.05 (low acuity) to >1.2 (greater acuity). If values were given for both the right eye and left eye, the value of the right eye was analyzed.|Baseline, 1 year, 2 years, and 3 years|All subjects group and all treatment groups populations||participants|||Number
806303|NCT01012245|Secondary|Subject Assessment of Satisfaction With Xalatan® Treatment|Number of subjects for assessment of subject satisfaction with Xalatan® treatment; categorized as excellent (full satisfaction), very good, good, moderate, sufficient, and insufficient (no satisfaction).|Baseline, 1 year, 2 years, and 3 years|Xalatan® treatment group only (subjects with Xalatan monotherapy at baseline visit).||participants|||Number
806304|NCT01012245|Secondary|Investigator Assessment of Xalatan® Efficacy|Number of subjects for Investigator assessment of the efficacy of Xalatan® treatment rated as excellent (highly effective), very good, good, moderate, sufficient, and insufficient (not effective).|Baseline, 1 year, 2 years, and 3 years|Xalatan® treatment group only (subjects with Xalatan® monotherapy at baseline visit).||participants|||Number
806305|NCT01012245|Primary|Change From Baseline in Optic Disc Excavation: Horizontal Cup to Disc Ratio|Mean horizontal cup to disc (cup/disc or C/D) ratio to assess the progression of glaucoma; calculated as the ratio of the diameter of the depression (cup) to that of the optical nerve head (disc). If values were given for both right and left eye, the value of the right eye was analyzed. Change calculated as mean of (value of cup/disc ratio at observation minus baseline value).|Baseline, 1 year, 2 years, and 3 years|All subjects group and all treatment groups populations. N=number of subjects with optic disc excavation data at baseline; (n)=number of subjects with analyzable data at observation for All subjects, Xalatan®, Betablockers, Xalacom®, and Other medications, respectively.||ratio||Standard Deviation|Mean
806306|NCT01012245|Primary|Change From Baseline in Optic Disc Excavation: Vertical Cup to Disc Ratio|Mean vertical cup to disc (cup/disc or C/D) ratio to assess the progression of glaucoma; calculated as the ratio of the diameter of the depression (cup) to that of the optical nerve head (disc). If values were given for both right and left eye, the value of the right eye was analyzed. Change calculated as mean of (value of cup/disc ratio at observation minus baseline value).|Baseline, 1 year, 2 years, and 3 years|All subjects group and all treatment groups populations. N=number of participants with optic disc excavation data at baseline; (n)=number of participants with analyzable data at observation for All subjects, Xalatan®, Betablockers, Xalacom®, and Other medications, respectively.||ratio||Standard Deviation|Mean
806307|NCT01012245|Primary|Aulhorn Stage (Visual Field Defects)|Number of subjects at each Aulhorn stage. Staged as: No scotoma; Stage I (relative scotomas only), Stage II (absolute scotomas without connection to the blind spot), Stage III (absolute scotomas with connection to the blind spot), Stage IV (absolute scotomas more than 1 quadrant affected), and Stage V (temporal residual visual field only). If values were given for both right and left eye, the value of the right eye was analyzed.|Baseline, 1 year, 2 years, and 3 years|All subjects group and all treatment groups populations||participants|||Number
806308|NCT01012245|Primary|Change From Baseline in Intraocular Pressure (IOP)|Mean IOP values measured by applanation tonometry. Only Goldman values are displayed; if values were given for both right and left eye, the value of the right eye was analyzed. Change (absolute difference) calculated as mean of (value of IOP at observation minus baseline value). Study course is reported by yearly intervals and clustered as 1 year (12±3 months), 2 years (24±3 months), and 3 years (36±3 months).|Baseline, 1 year, 2 years, and 3 years|All subjects group and each treatment group population. N=number of participants with IOP data at baseline; (n)=number of participants with analyzable data at observation for All subjects, Xalatan®, Betablockers, Xalacom®, and Other medications, respectively.||mm Hg||Standard Deviation|Mean
806309|NCT01012258|Secondary|Progression-Free Survival (PFS)|Progression-free survival was defined as the duration (in months) from first administration of trial treatment to first observation of PD (radiological or clinical, if radiological PD is not available), or death due to any cause. The PFS time of participants without observation of PD but death occurring after two or more missed consecutive tumor assessments (i.e. two-fold scheduled time interval of two consecutive tumor assessments) was censored on the date of last tumor assessment or first administration of trial treatment (whichever was later).|Baseline up to disease progression or withdrawal or 12 weeks after the last radiotherapy of the last participant|ITT population included all participants who received at least one dose of the IMP cetuximab or RT.||months||95% Confidence Interval|Median
806310|NCT01012258|Primary|Best Overall Response (BOR)|Best overall (objective) response was defined as the occurrence of complete response (CR) or partial response (PR) based on the investigator's assessment according to modified World Health Organization (WHO) criteria confirmed at a repeat assessment performed no less than 28 days after the criteria for response were first met. CR was defined as disappearance of all index lesions. PR was defined as a 50% or more decrease in the sum of the products of diameters (SOPD) of index lesions compared to the baseline SOPD, with no evidence of PD.|Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 3 months following the 8 weeks after the end of RT visit until the end of trial (EOT) visit|Intention-to-treat (ITT) population included all participants who received at least one dose of the investigational medicinal product (IMP) cetuximab or RT.||percentage of participants||95% Confidence Interval|Number
806311|NCT01012297|Secondary|Objective Response Rate as Measured by RECIST 1.1 Criteria|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|Up to 5 years|All randomized||percentage of participants||95% Confidence Interval|Number
806312|NCT01012297|Secondary|Frequency and Severity of Adverse Effects as Assessed by the CTCAE Version 4.0|"Count of participants with Adverse events (AEs) that are CTCAE Grade 3 or worse.
Please refer to the adverse event reporting for more detail."|Up to 5 years|All randomized.||Participants|||Count of Participants
806313|NCT01012297|Secondary|Overall Survival|"Overall survival (OS) was defined as the number of months between study enrollment and death from any cause. Patients still alive at the last followup were censored on the date of last CT Scan.
The product-limit method will be used to estimate the cumulative distribution of overall survival times for the patients assigned to each treatment group."|Up to 5 years|All randomized||months||95% Confidence Interval|Median
806314|NCT01012297|Primary|Progression-free Survival|"Progression free survival (PFS) was defined as the number of months between study enrollment and documentation of disease progression (RECIST 1.1) or death from any cause. Patients still alive and disease free at the last followup were censored on the date of last CT Scan.
Assessed with a log-rank test stratified by whether the patient had whole pelvic radiotherapy prior to starting the study treatment. The product-limit method will be used to estimate the cumulative distribution of PFS for the patients assigned to each treatment group."|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months|All randomized||months||95% Confidence Interval|Median
820397|NCT01143402|Other Pre-specified|Objective Disease Progression|per Response Evaluation Criteria In Solid Tumors (RECIST) criteria or death due to any cause in the absence of progression|assessed up to 5 years||||||
806315|NCT01012323|Secondary|Changes in the Physical and Mental Short Form-36 Health Survey Scores From Baseline to the End of the Study|The Quality of Life (QoL) questionnaire Short Form-36 Health Survey (SF-36-HS) was completed by participants ≥ 14 years of age. The SF-36-HS consists of 36 items organized into 8 subscales. The 8 subscales could be combined into 2 summary scores, physical and mental. The calculated summary scores were transformed to a range of 0-100, where a higher score indicates better health. A positive change score indicates improvement.|Baseline to end of the study (up to 12 months)|Full analysis set: All participants who received at least 1 complete treatment with NewGam and for whom data on infections were available from at least 1 post-treatment diary entry.||Units on a scale||Standard Deviation|Mean
806316|NCT01012323|Secondary|Changes in the Physical and Psychosocial Child Health Questionnaire-Parent Form Scores From Baseline to the End of the Study|The Quality of Life (QoL) questionnaire Child Health Questionnaire-Parent Form (CHQ-PF50) was completed by a parent or guardian in study participants < 14 years of age. The CHQ-PF50 consists of 50 items organized into 15 subscales.The 15 subscales could be combined into 2 summary scores, physical and psychosocial. The calculated summary scores were transformed to a range of 0-100, where a higher score indicates more positive functioning or better health status. A positive change score indicates improvement.|Baseline to end of the study (up to 12 months)|Full analysis set: All participants who received at least 1 complete treatment with NewGam and for whom data on infections were available from at least 1 post-treatment diary entry.||Units on a scale||Standard Deviation|Mean
806317|NCT01012323|Secondary|Percentage of Participants That Missed School or Work Due to an Infection||Baseline to end of the study (up to 12 months)|Full analysis set: All participants who received at least 1 complete treatment with NewGam and for whom data on infections were available from at least 1 post-treatment diary entry.||Percentage of participants|||Number
806318|NCT01012323|Secondary|Percentage of Participants With at Least 1 Episode of Fever||Baseline to end of the study (up to 12 months)|Full analysis set: All participants who received at least 1 complete treatment with NewGam and for whom data on infections were available from at least 1 post-treatment diary entry.||Percentage of participants|||Number
806319|NCT01012323|Secondary|Number of Participants Hospitalized Due to an Infection||Baseline to end of the study (up to 12 months)|Full analysis set: All participants who received at least 1 complete treatment with NewGam and for whom data on infections were available from at least 1 post-treatment diary entry.||Participants|||Number
806320|NCT01012323|Secondary|Number of Antibiotic Treatment Days Per Person-year of Treatment|The number of antibiotic treatment days per person-year of treatment was calculated by the following formula: Total number of antibiotic treatment days / patient-years of NewGam treatment.|Baseline to end of the study (up to 12 months)|Full analysis set: All participants who received at least 1 complete treatment with NewGam and for whom data on infections were available from at least 1 post-treatment diary entry.||Treatment days/person/year|||Number
806321|NCT01012323|Secondary|Number of Antibiotic Treatment Episodes Per Person-year of Treatment|The number of antibiotic treatment episodes per person-year of treatment was calculated by the following formula: Total number of antibiotic treatment episodes / patient-years of NewGam treatment.|Baseline to end of the study (up to 12 months)|Full analysis set: All participants who received at least 1 complete treatment with NewGam and for whom data on infections were available from at least 1 post-treatment diary entry.||Treatment episodes/person/year|||Number
806322|NCT01012323|Secondary|Percentage of Participants Treated With Antibiotics|The total percentage of participants treated with antibiotics, as well as, the percentage of participants treated with antibiotics therapeutically and prophylactically are reported.|Baseline to end of the study (up to 12 months)|Full analysis set: All participants who received at least 1 complete treatment with NewGam and for whom data on infections were available from at least 1 post-treatment diary entry.||Percentage of participants|||Number
806323|NCT01012323|Secondary|Time to Resolution of Serious and Other Infections|Since infections were reported as adverse events, the time to resolution of an infection was the time from the start date of the infection adverse event to the end date of the infection adverse event.|Baseline to end of the study (up to 12 months)|Full analysis set: All participants who received at least 1 complete treatment with NewGam and for whom data on infections were available from at least 1 post-treatment diary entry.||Days||Standard Deviation|Mean
806324|NCT01012323|Secondary|Number of Non-serious Infections|The MedDRA preferred term was used to determine the type of non-serious infection. They were grouped into the following categories as determined by a medical expert: Ear infections, eye infections, infections of the gastrointestinal tract, infections of the genitourinary tract, upper respiratory tract infections, lower respiratory tract infections, infections of the skin, and infections not elsewhere classified. The total number of infections and the number in each category are reported.|Baseline to end of the study (up to 12 months)|Full analysis set: All participants who received at least 1 complete treatment with NewGam and for whom data on infections were available from at least 1 post-treatment diary entry.||Infections|||Number
806325|NCT01012323|Secondary|Total Number of Infections|The number of infections included serious bacterial infections (bacterial pneumonia, bacteraemia/sepsis, osteomyelitis/septic arthritis, visceral abscess, bacterial meningitis) and other infections. For other infections, the Medical Dictionary for Regulatory Activities (MedDRA) preferred term was used to determine the type of infection. They were grouped into the following categories as determined by a medical expert: Ear infections, eye infections, infections of the gastrointestinal tract, infections of the genitourinary tract, upper respiratory tract infections, lower respiratory tract infections, infections of the skin, and infections not elsewhere classified.|Baseline to end of the study (up to 12 months)|Full analysis set: All participants who received at least 1 complete treatment with NewGam and for whom data on infections were available from at least 1 post-treatment diary entry.||Infections|||Number
806326|NCT01012323|Secondary|Trough Level Concentration of Antibodies Against Varicella-zoster Virus|Trough level concentrations of antibodies against varicella-zoster virus were measured in serum blood samples collected before the 1st infusion in all participants, before the 9th and 10th infusions in participants receiving NewGam every 3 weeks, before the 7th and 8th infusions in participants receiving NewGam every 4 weeks, and at the termination visit for all participants.|Baseline to end of the study (up to 12 months)|Pharmacokinetic set: All participants who had concentration data for at least 1 of the pre-infusion IgG trough levels.||U/mL||Standard Deviation|Mean
820575|NCT01145898|Primary|3-year Change in OA PSV|Measurement of change in ocular blood flow - ophthalmic artery peak systolic velocity|Baseline and 36 month visits|||cm/sec||Standard Error|Mean
806327|NCT01012323|Secondary|Trough Level Concentration of Antibodies Against Tetanus|Trough level concentrations of antibodies against tetanus were measured in serum blood samples collected before the 1st infusion in all participants, before the 9th and 10th infusions in participants receiving NewGam every 3 weeks, before the 7th and 8th infusions in participants receiving NewGam every 4 weeks, and at the termination visit for all participants.|Baseline to end of the study (up to 12 months)|Pharmacokinetic set: All participants who had concentration data for at least 1 of the pre-infusion IgG trough levels.||IU/mL||Standard Deviation|Mean
806328|NCT01012323|Secondary|Trough Level Concentration of Antibodies Against Cytomegalovirus|Trough level concentrations of antibodies against cytomegalovirus were measured in serum blood samples collected before the 1st infusion in all participants, before the 9th and 10th infusions in participants receiving NewGam every 3 weeks, before the 7th and 8th infusions in participants receiving NewGam every 4 weeks, and at the termination visit for all participants.|Baseline to end of the study (up to 12 months)|Pharmacokinetic set: All participants who had concentration data for at least 1 of the pre-infusion IgG trough levels.||U||Standard Deviation|Mean
806329|NCT01012323|Secondary|Trough Level Concentration of Antibodies Against Streptococcus Pneumoniae|Trough level concentrations of antibodies against Streptococcus pneumoniae (serotypes types 6B, 14, 9V, 18C, 19F, 4, and 23F) were measured in serum blood samples collected before the 1st infusion in all participants, before the 9th and 10th infusions in participants receiving NewGam every 3 weeks, before the 7th and 8th infusions in participants receiving NewGam every 4 weeks, and at the termination visit for all participants.|Baseline to end of the study (up to 12 months)|Pharmacokinetic set: All participants who had concentration data for at least 1 of the pre-infusion IgG trough levels.||µg/mL||Standard Deviation|Mean
806330|NCT01012323|Secondary|Trough Level Concentration of Antibodies Against Measles|Trough level concentrations of antibodies against measles were measured in serum blood samples collected before the 1st infusion in all participants, before the 9th and 10th infusions in participants receiving NewGam every 3 weeks, before the 7th and 8th infusions in participants receiving NewGam every 4 weeks, and at the termination visit for all participants.|Baseline to end of the study (up to 12 months)|Pharmacokinetic set: All participants who had concentration data for at least 1 of the pre-infusion IgG trough levels.||mIU/mL||Standard Deviation|Mean
806331|NCT01012323|Secondary|Trough Level Concentration of Antibodies Against Haemophilus Influenzae|Trough level concentrations of antibodies against Haemophilus influenzae were measured in serum blood samples collected before the 1st infusion in all participants, before the 9th and 10th infusions in participants receiving NewGam every 3 weeks, before the 7th and 8th infusions in participants receiving NewGam every 4 weeks, and at the termination visit for all participants.|Baseline to end of the study (up to 12 months)|Pharmacokinetic set: All participants who had concentration data for at least 1 of the pre-infusion IgG trough levels.||µg/mL||Standard Deviation|Mean
806332|NCT01012323|Secondary|IgG Trough Level Concentration|Total IgG trough concentrations were measured in serum samples taken before each infusion.|Baseline to end of the study (up to 12 months)|Pharmacokinetic set: All participants who had concentration data for at least 1 of the pre-infusion IgG trough levels.||g/L||Standard Deviation|Mean
806333|NCT01012323|Primary|Number of Serious Bacterial Infections Per Person-year of Treatment|The number of serious bacterial infections per person-year of treatment was calculated by the following formula: Total number of serious bacterial infections / patient-years on NewGam treatment. Serious bacterial infections were defined as bacteraemia/sepsis, bacterial meningitis, osteomyelitis/septic arthritis, bacterial pneumonia, and visceral abscess.|Baseline to end of the study (up to 12 months)|Full analysis set: All participants who received at least 1 complete treatment with NewGam and for whom data on infections were available from at least 1 post-treatment diary entry.||Serious infections per person-year of tr|||Number
806334|NCT01012336|Secondary|Time to First Vomiting Episode or Use of Rescue Medication||120 hours||||||
806335|NCT01012336|Secondary|Efficacy of the Aprepitant/Ramosetron/Dexamethasone Regimen in Terms of the Proportion of Patients With no Vomiting During the 120 Hour Following Initiation of Chemotherapy||120 hours||||||
806336|NCT01012336|Primary|Safety and Tolerability of the Aprepitant/Ramosetron/Dexamethasone Regimen||120 hours||||||
806337|NCT01012336|Primary|Efficacy of the Aprepitant/Ramosetron/Dexamethasone Regimen in Terms of the Proportion of Patients With a Complete Response (CR) During the 120 Hour Following Initiation of Chemotherapy.|Complete Response is defined as No vomiting with no rescue therapy. These response criteria will be applied to the following time periods: Overall: from 0 (chemotherapy initiation) to the morning of day 6, Acute: 0 to 24 hours following the initiation of chemotherapy, Delayed: 25 hours to the morning of day 6(D6).|120 hours|||Percentage of Participants|||Number
806338|NCT01012362|Secondary|Number of Participants With Treatment-Related Adverse Events|Includes all treatment-related adverse events experienced during and subsequent to Cycle 1.|Up to 30 days post treatment|Dose Level 3 includes participants from Arm 1: Dose Level 3 and Arm 2 combined.||Participants|||Count of Participants
806339|NCT01012362|Primary|Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)|A DLT was defined as one of the following events occurring during cycle 1: (1) grade 4 or greater treatment-related hematologic toxicity for >7 days; (2) grade 3 or greater treatment-related clinical non-hematologic toxicity (excluding >/= grade 3 nausea, vomiting, or diarrhea without maximal medical intervention and/or prophylaxis); or (3) delay of starting cycle 2 treatment by >2 weeks due to incomplete hematologic recovery (absolute neutrophil count > 1.5 X 10^9/L or platelets >100 X 10^9/L) or unresolved treatment-related grade 3 or greater non-hematologic toxicity. Adverse events were classified according to Common Terminology Criteria for Adverse Events V 3.0 (CTCAE).|Week 3 of each dose|6 participants were included at Dose Level 1 to confirm safety after escalation to Dose level 2, but are grouped with the original 3 participants enrolled at Dose Level 1.||Participants|||Count of Participants
806356|NCT01012622|Secondary|Change From Baseline in Academic Performance Rating Scale (APRS) Score at Week 12|APRS scale measures four factors in elementary school children such as learning ability, academic performance, impulse control, and social withdrawal. In particular, it is excellent in assessing drug effect on the academic performance not measured by other scales. Score ranges from 19 to 95, higher score means better academic performance.|Baseline and Week 12|ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. LOCF method was used. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.||units on a scale||Standard Deviation|Mean
806340|NCT01012362|Primary|The Optimal Tolerated Regimen of Pazopanib and Ixabepilone When Used in Combination|The optimal tolerated regimen is the regimen where ≤ 1 out of 6 patients experiences a dose limiting toxicity (DLT). DLT is defined as one of the following events occurring during cycle 1: grade 4 or greater treatment related hematologic toxicity for > 7 days during the first cycle (21 days) of therapy; grade 3 or greater treatment related clinical non-hematological toxicity (excluding ≥ grade 3 nausea, vomiting, or diarrhea without maximal medical intervention and/or prophylaxis) during the first cycle (21 days) of therapy; or a delay of cycle 2 treatment start by more than 2 weeks due to incomplete hematologic recovery (ANC > 1.5 x 109/L or platelets 100 x 109/L) or unresolved treatment related grade 3 or greater non-hematologic toxicity.|Week 3 of each dose level|||Dose Level|||Number
806341|NCT01012388|Primary|Number Participants With Hypertropic Scarring, Keloid Formation, Hyper- or Hypopigmentation in Patients With Fitzpatrick Skin Types IV, V, and VI Receiving Nasolabial Fold Treatment|Skin type IV - Burns minimally, tans moderately and easily, Skin type V - Rarely burns, tans profusely; Skin type VI - Never burns, tans profusely|6 months|||participants|||Number
806342|NCT01012388|Primary|Number Participants With Hypertropic Scarring, Keloid Formation, Hyper- or Hypopigmentation in Patients With Fitzpatrick Skin Types IV, V, and VI Receiving Nasolabial Fold Treatment|Skin type IV - Burns minimally, tans moderately and easily, Skin type V - Rarely burns, tans profusely; Skin type VI - Never burns, tans profusely|3 months|||Participants|||Number
806343|NCT01012414|Secondary|Effect on Carotid Intima-media Thickening (CIMT)||1 year|Data were not collected when study was stopped prematurely.|||||
806344|NCT01012414|Secondary|Effect on Known Coronary Artery Disease Risk Factors Including Lipids and Blood Pressure.||1 year|Data were not collected when study was stopped prematurely.|||||
806345|NCT01012414|Secondary|Change in Markers of Inflammation Including Interleukin (IL)-1, IL-6, Tumor Necrosis Factor Alpha, Matrix Metalloproteinase (MMP) -9 and Serum Amyloid A||1 year|Data were not collected when study was stopped prematurely.|||||
806346|NCT01012414|Primary|Change in High Sensitivity-C Reactive Protein (Serum)||1 year|Data were not collected when study was stopped prematurely.|||||
806347|NCT01012440|Primary|Reduction in Tumor Size|Comparison of tumor size pre chemotherapy and post chemotherapy represents the PEM data. There is no the response with MRI because the study was aborted and very few patients were involved.|1-2 weeks post treatment onset|This study has been terminated due to poor accrual.||mm||Standard Deviation|Mean
806352|NCT01012622|Secondary|Clinical Global Impression - Improvement (CGI-I) Scale Score at Week 12|The CGI-I is a 7-point scale that requires the clinician to assess how much the participant’s illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. Improved very much, Improved much and Improved a little are defined as improvement and No change, Aggravated a little, Aggravated much and Aggravated very much were defined as aggravation.|Week 12|ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.||participants|||Number
806353|NCT01012622|Secondary|Change From Baseline in Clinical Global Impression-severity (CGI-S) Score at Week 12|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher change scores indicate worsening."|Baseline and Week 12|ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. LOCF method was used.||units on a scale||Standard Deviation|Mean
806354|NCT01012622|Secondary|Change From Baseline in Parenting Stress Index (PSI) Total Score at Week 12|Parenting Stress Index (PSI) was designed to assess parent or guardian child-rearing stress index on a 5-rating scale from ”never” to “very truly”. Out of 30 items, 20 items are scored, being consisted of 8 child characteristics-related stress items; 9 parent-child interaction-related stress items; and 3 achievement expectation-related stress items. A possible total score ranges from 20 to 100; Increase in score indicates higher stress perceived by the parent.|Baseline and Week 12|ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. LOCF method was used. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.||units on a scale||Standard Deviation|Mean
806355|NCT01012622|Secondary|Change From Baseline in Beck Depression Inventory (BDI) Score at Week 12|Beck Depression Inventory (BDI) consisted of 21 items for measuring the subjective severity of depression and emotional, cognitive, motivational, physiological symptoms of depression. Each question has a set of 4 possible answer choices, ranging in intensity, each answer being scored on a scale value of 0 (no symptom) to 3 (the most severe symptom). Accordingly, the total score ranges from 0 (no symptom) to 63 (the most severe symptom) for 21 questions.|Baseline and Week 12|ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. LOCF method was used. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.||units on a scale||Standard Deviation|Mean
806401|NCT01013207|Secondary|Usability of the Nexus (S9) CPAP.|The usability quesitonnaire was administered at the end of the 4 week trial of Nexus (S9). Usability was defined as ease of using the Nexus (S9) and overall satisfaction with the Nexus (S9) CPAP. The outcome measure was collected through 11 point Likert questionnaires, where 0 = very poor usability and 10 = excellent usability.|4 weeks|||Units on a scale||Standard Deviation|Mean
806357|NCT01012622|Secondary|Change From Baseline in Working Memory Backward Subtest of Comprehensive Attention Test (CAT) at Week 12|CAT was developed to properly reflect brain function in childhood. The test battery provided a comprehensive measurement of simple visual auditory attention, interventional visual-auditory selective attention, divided attention, continuous attention, and operational memory. Working memory forward was measured in terms of width of space and number of correct responses ranging from 0 to 10. For width of space boxes were presented on the screen and participants remembered the order of presented box. Participants pressed the box using mouse in the backward order. Maximum number that participants correctly memorized box in the screen in the respective order was reported and overall number of times a participant responded correctly was also reported.|Baseline and Week 12|ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. LOCF method was used. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.||correct responses||Standard Deviation|Mean
806358|NCT01012622|Secondary|Change From Baseline in Working Memory Forward Subtest of Comprehensive Attention Test (CAT) at Week 12|CAT was developed to properly reflect brain function in childhood. The test battery provided a comprehensive measurement of simple visual auditory attention, interventional visual-auditory selective attention, divided attention, continuous attention, and operational memory. Working memory forward was measured in terms of width of space and number of correct responses ranging from 0 to 10. For width of space boxes were presented on the screen and participants remembered the order of presented box. Participants pressed the box using mouse in the forward order. Maximum number that participants correctly memorized box in the screen in the respective order was reported and overall number of times a participant responded correctly was also reported.|Baseline and Week 12|ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. LOCF method was used. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.||correct responses||Standard Deviation|Mean
806359|NCT01012622|Secondary|Change From Baseline in Divided Attention Subtest of Comprehensive Attention Test (CAT) at Week 12|CAT was developed to properly reflect brain function in childhood. It provided measurement of simple divided attention in terms of omission(number of missing response to target stimulus[0-150], higher score indicate greater omission), false alarm(number of response to non-target stimulus[0-150], higher score indicate greater false alarm), response mean (average time spent to response to target stimulus [200-1100, low score means faster response to target stimulus]), Response (consistency of response time to target stimulus [30-650, Low score means good consistency of response]).|Baseline and Week 12|ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. LOCF method was used. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.||units on a scale||Standard Deviation|Mean
806360|NCT01012622|Secondary|Change From Baseline in Interference-Selective Attention Subtest of Comprehensive Attention Test (CAT) Total Score at Week 12|CAT was developed to properly reflect brain function in childhood. It provided measurement of simple interference-selective attention in terms of omission(number of missing response to target stimulus[0-150], higher score indicate greater omission), false alarm(number of response to non-target stimulus[0-150], higher score indicate greater false alarm), response mean (average time spent to response to target stimulus [200-1100, low score means faster response to target stimulus]), Response (consistency of response time to target stimulus [30-650, Low score means good consistency of response]).|Baseline and Week 12|ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. LOCF method was used. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.||units on a scale||Standard Deviation|Mean
806361|NCT01012622|Secondary|Change From Baseline in Inhibition-Sustained Attention Subtest of Comprehensive Attention Test (CAT) Total Score at Week 12|CAT was developed to properly reflect brain function in childhood. It provided measurement of simple inhibition-sustained attention in terms of omission(number of missing response to target stimulus [0-150], higher score indicate greater omission), false alarm(number of response to non-target stimulus [0-150], higher score indicate greater false alarm), response mean (average time spent to response to target stimulus [200-1100, low score means faster response to target stimulus]), Response (consistency of response time to target stimulus [30-650, Low score means good consistency of response]).|Baseline and Week 12|ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. LOCF method was used. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.||units on a scale||Standard Deviation|Mean
806362|NCT01012622|Secondary|Change From Baseline in Auditory Selective Attention Subtest of Comprehensive Attention Test (CAT) Total Score at Week 12|CAT was developed to properly reflect brain function in childhood. It provided measurement of simple auditory selective attention in terms of omission (number of missing response to target stimulus [0-150], higher score indicate greater omission), false alarm (number of response to non-target stimulus [0-150], higher score indicate greater false alarm), response mean (average time spent to response to target stimulus [200-1100, low score means faster response to target stimulus]), Response (consistency of response time to target stimulus [30-650, Low score means good consistency of response]).|Baseline and Week 12|ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. LOCF method was used. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.||units on a scale||Standard Deviation|Mean
806363|NCT01012622|Secondary|Change From Baseline in Visual Selective Attention Subtest of Comprehensive Attention Test (CAT) Total Score at Week 12|CAT was developed to properly reflect brain function in childhood. It provided measurement of simple visual selective attention in terms of omission (number of missing response to target stimulus [0-150], higher score indicate greater omission), false alarm (number of response to non-target stimulus [0-150], higher score indicate greater false alarm), response mean (average time spent to response to target stimulus [200-1100, low score means faster response to target stimulus]), Response (consistency of response time to target stimulus [30-650, Low score means good consistency of response]).|Baseline and Week 12|ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. LOCF method was used. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.||units on a scale||Standard Deviation|Mean
806364|NCT01012622|Secondary|Change From Baseline in Child Health and Illness Profile-Child Edition (CHIP) Total Score and 5 Sub-domains Score at Week 12|CHIP was designed to assess the physical, psychological health conditions and functional well-being of children. The instrument has sub-domains such satisfaction (11 items) ranges from 0 to 44, stability (22 items) ranges from 0 to 88, elasticity (19 items) ranges from 0 to 76, risk aversion (14 items) ranges from 0 to 56, achievement (10 items) ranges from 0 to 40. Good health is in the range from 44 to 56 points for all sub-domains. A score of 43 or below indicates poor health in that domain. A score of 57 or higher indicates excellent health. The total score is an average of the scores for the 5 domains and ranges from 0 to 304. Higher total score indicates better health.|Baseline and Week 12|"ITT population included participants who took study drug at least once and had primary efficacy endpoint data available. Last Observation Carried Forward (LOCF) method was used. n signifies participants who were evaluated for each specified category for this measure."||units on a scale||Standard Deviation|Mean
806365|NCT01012622|Primary|Number of Participants With Remission Based on K-ARS Total Score and Clinical Global Impression – Improvement (CGI-I) Scale Score at Week 12|Remission is defined by all of the following criteria; 1) K-ARS Total score of 18 or less. 2) “Very much improved” or “Much improved” in CGI-I. K-ARS total score ranges from 0 (no symptoms) to 54 (highly symptomatic), higher score indicates worsening of condition. CGI-I is a 7-point scale ranging from 1 to 7, where 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse, higher score indicates worsening of condition.|Week 12|ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.||participants|||Number
806366|NCT01012622|Primary|Number of Participants With Response Based on K-ARS Total Score at Week 12|Response is defined as at least 25 percent (%) decrease in total score of K-ARS compared to baseline. K-ARS measures the 18 symptoms based on DSM-IV (1994). Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often), whereas the rating of 2 points or more was regarded as abnormal. Total scores range from 0 (no symptoms) to 54 (highly symptomatic), higher score indicates worsening of condition.|Week 12|ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.||participants|||Number
806367|NCT01012622|Primary|Change From Baseline in Korean Version of the Attention-Deficit Hyperactivity Disorder (K-ADHD) Rating Scale (K-ARS) Total Score at Week 12|K-ARS measures the 18 symptoms based on Diagnostic and Statistical Manual of Mental Disorders-forth edition (DSM-IV 1994). Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often), whereas the rating of 2 points or more was regarded as abnormal. Total scores range from 0 (no symptoms) to 54 (highly symptomatic), higher score indicates worsening of condition.|Baseline and Week 12|Intention-to-treat (ITT) population included participants who received the study drug at least once and had the primary efficacy endpoint data available||units on a scale||Standard Deviation|Mean
806368|NCT01012661|Primary|Patients With Clinically Significant Reduction in Pain|Assessment of clinical significance of pain reduction in the Radiesse Injectable Dermal Filler Mixed with Lidocaine nasolabial fold v. Radiesse Injectable Dermal Filler without Lidocaine nasolabial fold defined as number of participants with >/= 2cm difference on a visual analog pain scale (1 = no pain, 10 = very severe pain).|Immediately after injection (Time 0)|||Participants|||Number
806369|NCT01012661|Primary|Pain Score Using a 10-cm Visual Analog Pain Scale (1 = no Pain, 10 = Very Severe Pain)|Assessment of difference in pain score in the Radiesse Dermal Filler Mixed with Lidocaine nasolabial fold v. the Radiesse Dermal Filler without Lidocaine nasolabial fold using a 10-cm visual analog pain scale (1 = no pain, 10 = very severe pain).|Immediately after injection (Time 0)|||cm||Standard Deviation|Mean
806370|NCT01012674|Primary|Specificity|Rate of true non-stenotic segments (i.e. without stenosis >= 70%) of TOF and Dotarem-enhanced MRA evaluated by 3 independent off-site readers at the segment level, with CTA as standard of truth (re-read DGD-44-061).|2 - 42 days|||percentage of arterial segments|Participants|95% Confidence Interval|Number
806371|NCT01012674|Primary|Sensitivity|Rate of true stenotic segments (i.e. with stenosis >= 70%) of TOF and Dotarem-enhanced MRA evaluated by 3 independent off-site readers at the segment level, with CTA as standard of truth (re-read DGD-44-061).|2-42 days|||percentage of arterial segments|Participants|95% Confidence Interval|Number
806372|NCT01012674|Primary|Technical Failure Rate|Rate of non-assessable arterial segments as measured by 3 independent readers in off-site evaluation of TOF-MRA and Dotarem-enhanced MRA (re-read DGD-44-061).|2 - 28 days|||percentage of arterial segments|Participants|95% Confidence Interval|Number
806373|NCT01012713|Secondary|A Tertiary Endpoint Will be the Percentage of Patients Achieving 90% Reduction in Psoriasis Area and Severity Index at Week 12.||12 weeks|||percent||95% Confidence Interval|Number
806374|NCT01012713|Secondary|The Secondary Endpoint Will be the Percentage of Patients Achieving a 75% Reduction in Psoriasis Area and Severity Index at Weeks 4 and 8.||8 weeks|||percent||95% Confidence Interval|Number
806375|NCT01012713|Primary|The Primary Endpoint Will be the Percentage of Patients Achieving a 75% Reduction in the Psoriasis Area and Severity Index at Week 12.||12 weeks|||percent||95% Confidence Interval|Number
806376|NCT01012739|Secondary|Indacaterol Exposure (Cmax) for Each Treatment|All patients fasted for at least 10 hours prior to administration of study medication and continued to fast for at least 4 hours thereafter. Venous blood samples for pharmacokinetic evaluation were collected at 5, 10, 15, and 30 minutes; and 1, 2, 4, 8, and 24 hours post-dose in each treatment period and were analyzed using a LC-MS/MS assay. Maximum (peak) plasma drug concentration after drug administration (Cmax) was calculated from concentration-time data using non-compartmental analysis.|0 to 24 hours post-dose|Pharmacokinetic analysis set: All randomized patients with evaluable pharmacokinetic data, ie, from which at least one pharmacokinetic parameter could be determined and sampling time information was available, from at least one treatment period.||pg/mL||Standard Deviation|Mean
806402|NCT01013207|Primary|Compliance on CPAP|Compliance on CPAP was measured as average daily usage|12 weeks|||Hours||Standard Deviation|Mean
806403|NCT01013597|Secondary|Tolerability of LBH589|Tolerability and toxicity were not assessed separately, therefore tolerability is reported as toxicity.|Every 4 weeks, up to 5 years||||||
806377|NCT01012739|Secondary|Indacaterol Exposure (AUC[0-24 Hours]) for Each Treatment|All patients fasted for at least 10 hours prior to administration of study medication and continued to fast for at least 4 hours thereafter. Venous blood samples for pharmacokinetic evaluation were collected at 5, 10, 15, and 30 minutes; and 1, 2, 4, 8, and 24 hours post-dose in each treatment period and were analyzed using a LC-MS/MS assay. Area under the concentration-time curve up to 24 hours (AUC[0-24 hours]) was calculated from concentration-time data using non-compartmental analysis.|0 to 24 hours post-dose|Pharmacokinetic analysis set: All randomized patients with evaluable pharmacokinetic data, ie, from which at least one pharmacokinetic parameter could be determined and sampling time information was available, from at least one treatment period.||pg*hr/mL||Standard Deviation|Mean
806378|NCT01012739|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose for Each Treatment|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5, 15, and 30 minutes; and 1, 2, and 4 hours post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time.|From 5 minutes to 4 hours post-dose for each treatment|Pharmacodynamic analysis set: All randomized patients that received at least 1 dose of study drug and had a baseline and at least 1 post-baseline measurement of FEV1.||Liters||Standard Deviation|Mean
806379|NCT01012739|Secondary|Time to Peak Forced Expiratory Volume in 1 Second (FEV1) for Each Treatment|FEV1 was measured with spirometry conducted according to internationally accepted standards at 5, 15, and 30 minutes; 1 hour, 1 hour 30 minutes; and 1, 2, 4, 6, 8, and 12 hours post-dose in Day 1.|From 5 minutes to 12 hours post-dose|Pharmacodynamic analysis set: All randomized patients that received at least 1 dose of study drug and had a baseline and at least 1 post-baseline measurement of FEV1.||Hours||Standard Deviation|Mean
806380|NCT01012739|Secondary|Change From Baseline in Peak Forced Expiratory Volume in 1 Second (FEV1) for Each Treatment|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5, 15, and 30 minutes; and 1, 2, 4, 6, 8, and 12 hours post-dose in Day 1.|Baseline and Day 1|Pharmacodynamic analysis set: All randomized patients that received at least 1 dose of study drug and had a baseline and at least 1 post-baseline measurement of FEV1.||Liters||Standard Deviation|Mean
806381|NCT01012739|Primary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose for Each Treatment|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose for each treatment.|Baseline and Day 1|Pharmacodynamic analysis set: All randomized patients that received at least 1 dose of study drug and had a baseline and at least 1 post-baseline measurement of FEV1.||Liters||Standard Deviation|Mean
806382|NCT01012765|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) After 20 Days of Treatment|FEV1 was measured with spirometry conducted according to internationally accepted standards. FEV1 was measured pre-dose after 20 days of treatment. Analysis of variance model was used with the factors: center, period, treatment, and patients within center.|20 days|Full analysis set (FAS) included all randomized patients who received at least one dose of study medication during at least one study period. Participants with observations after 20 days were included in the analysis.||Liters||95% Confidence Interval|Least Squares Mean
806383|NCT01012765|Secondary|FEV1 30 Minutes Post-dose After 21 Days of Treatment|FEV1 was measured with spirometry conducted according to internationally accepted standards. FEV1 was measured 30 minutes post-dose. Analysis of variance model was used with the factors: center, period, treatment, and patients within center.|21 days|Full analysis set (FAS) included all randomized patients who received at least one dose of study medication during at least one study period. Participants with observations after 21 days were included in the analysis.||Liters||95% Confidence Interval|Least Squares Mean
806384|NCT01012765|Secondary|Peak Specific Airway Resistance (sRaw) After 21 Days of Treatment|Peak sRaw was measured with spirometry conducted according to internationally accepted standards. Peak sRaw was the mean of the three measurements which were measured each at 30 min, 2 hours, 3 hours and 4 hours post dose (at days 21, 55 and 89). Analysis of variance model was used with the factors: center, period, treatment, and patients within center.|21 days|Full analysis set (FAS) included all randomized patients who received at least one dose of study medication during at least one study period. Participants with observations after 21 days were included in the analysis.||kPa*sec||95% Confidence Interval|Least Squares Mean
806385|NCT01012765|Secondary|Peak Residual Volume/Peak Total Lung Capacity (RV/TLC) Ratio After 21 Days of Treatment|Peak RV/TLC ratio was measured with spirometry conducted according to internationally accepted standards. Peak RV/TLC was defined as the peak RV/peak TLC. Analysis of variance model was used with the factors: center, period, treatment, and patients within center.|21 days|Modified intent-to-treat (mITT) excluded patients from centers who performed invalid body plethysmography. Participants with observations after 21 days were included in this analysis.||Ratio||95% Confidence Interval|Least Squares Mean
806386|NCT01012765|Secondary|Peak Total Lung Capacity (TLC) After 21 Days of Treatment|TLC was measured with spirometry conducted according to internationally accepted standards. Peak TLC was calculated as the mean of the three Functional Residual Capacity peak measurements plus the mean of the three Inspiratory Capacity measurements which were measured each at 30 min, 2 hours, 3 hours and 4 hours post dose (at days 21, 55 and 89). Analysis of variance model was used with the factors: center, period, treatment, and patients within center.|21 days|Modified intent-to-treat (mITT) excluded patients from centers who performed invalid body plethysmography. Participants with observations after 21 days were included in this analysis.||Liters||95% Confidence Interval|Least Squares Mean
806387|NCT01012765|Secondary|Peak Residual Volume (RV) After 21 Days of Treatment|Peak RV was measured with spirometry conducted according to internationally accepted standards. Peak RV was calculated as the Total Lung Capacity minus the maximum of the three Inspiratory Vital Capacity measurements which were measured each at 30 min, 2 hours, 3 hours and 4 hours post dose (at days 21, 55 and 89). Analysis of variance model was used with the factors: center, period, treatment, and patients within center.|21 days|Modified intent-to-treat (mITT) excluded patients from centers who performed invalid body plethysmography. Participants with observations after 21 days were included in this analysis.||Liters||95% Confidence Interval|Least Squares Mean
810309|NCT01050764|Secondary|To Measure the Incidence and Severity of Acute and Chronic GvHD|Population of participants that received HSCT and T-reg plus T-con, and developed actue, chronic, or any graft vs host disease (GvHD)|1 year|||Participants|||Count of Participants
806388|NCT01012765|Secondary|Trough IC After 20 Days of Treatment|Trough IC was measured with spirometry conducted according to internationally accepted standards. Trough IC was calculated as the mean of the three measurements of pre-dose body plethysmography (days 21, 55 and 89). Analysis of variance model was used with the factors: center, period, treatment, and patients within center.|20 days|Modified intent-to-treat (mITT) excluded patients from centers who performed invalid body plethysmography. Participants with observations after 20 days were included in this analysis.||Liters||95% Confidence Interval|Least Squares Mean
806389|NCT01012765|Primary|Peak Inspiratory Capacity (IC) After 21 Days of Treatment|IC was measured with spirometry conducted according to internationally accepted standards. Peak IC was defined as the maximum IC of the mean over the 3 values which were measured each at 30min, 2 hour, 3 hour and 4 hour post dose by body plethysmography. Analysis of variance model was used with the factors: center, period, treatment, and patients within center.|21 days|Full analysis set (FAS) included all randomized patients who received at least one dose of study medication during at least one study period. Participants with observations after 21 days were included in the analysis.||Liters||95% Confidence Interval|Least Squares Mean
806390|NCT01012947|Primary|Change of Cognitive Function Measured by a Mini Mental State Examination Scores on a Scale According to Study Group|"The mini–mental state examination (MMSE) or Folstein test is a brief 30-point questionnaire test that is used to screen for cognitive impairment. It ranges from 0 to 30 points. The higher scores mean better outcome. It is also used to estimate the severity of cognitive impairment at a given point in time and to follow the course of cognitive changes in an individual over time, thus making it an effective way to document an individual's response to treatment.
In the time span of about 10 minutes it samples various functions including arithmetic, memory and orientation."|baseline and 18 months|The location of the survey was Suwon City, with a population of 1 million, located adjacent to Seoul, the nation's capital. The center, which has been established since 2008 and has outreach sites throughout the districts, provides a range of social, health, educational, and recreational services for users of elderly groups.||units on a scale||Standard Deviation|Mean
806391|NCT01012973|Secondary|Change From Baseline in European Five-dimensional Health Scale (EQ-5D) Score at Week 24 - LOCF|EQ-5D is a quality of life questionnaire based on a scale from -0.594 (worst) to 1.00 (best).|Baseline and Week 24|Full-Analysis Set with assessment for this outcome measure; imputation technique: LOCF||Scores on a scale||Standard Deviation|Mean
806392|NCT01012973|Secondary|Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Total Score at Week 24 - LOCF|The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales which are all scored from 0-100. To reach the overall composite score, each sub-scale score is averaged in order to give each sub-scale equal weight|Baseline and Week 24|Full-Analysis Set with assessment for this outcome measure; imputation technique: LOCF||Scores on a scale||Standard Deviation|Mean
806393|NCT01012973|Secondary|Percentage of Participants Who Developed Neovascularization During the First 24 Weeks|Formation of blood vessels in the anterior segment, optic disc, or elsewhere in the fundus up to Week 24|From baseline until Week 24|Full analysis set||Percentage of participants|||Number
806394|NCT01012973|Secondary|Change From Baseline in Central Retinal Thickness (CRT) at Week 24 - LOCF||Baseline and Week 24|Full-Analysis Set with assessment for this outcome measure; imputation technique: LOCF||microns||Standard Deviation|Mean
806395|NCT01012973|Secondary|Change From Baseline in BCVA as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 24 - Last Observation Carried Forward (LOCF)|Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 24 (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning. However, because this was assessed at the screening visit, subjects may have had a higher BCVA recorded at the baseline visit and would not have been excluded from the study.|Baseline and Week 24|Full analysis set||Letters correctly read||Standard Deviation|Mean
806396|NCT01012973|Primary|Percentage of Participants Who Gained at Least 15 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 24 With Discontinued Participants Before Week 24 Evaluated as Failures|Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 24 (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.|Baseline and Week 24|Full analysis set||Percentage of participants|||Number
806397|NCT01012999|Primary|Pain Relief at Thirty Minutes|Measured pain relief on a visual analog scale (0-10- ten being the worst pain and zero being no pain at all).|30 min post dose|||Units on a scale||Standard Deviation|Mean
806398|NCT01013194|Secondary|Analysis of Meld Score From Baseline to 1 Year Follow-up|"Assessment of the efficacy of human fetal liver progenitor cell transplantation on Meld score.
The Model for End-stage Liver Disease (MELD) scoring system aims at stratifying recipients by their disease severity according to a score estimating the 3-month probability of death on the waiting list. The calculation of an individual’s MELD score is based on three objective lab parameters (bilirubin, serum creatinine and prothrombin time expressed as international normalized ratio, INR) and it includes logarithmic transformations and multiplication by several factors. It ranges between 6 and 40. The highest is the score the lower is the patient’s survival."|Baseline and 1 year Follow-up|||units on a scale||Standard Deviation|Mean
806399|NCT01013194|Secondary|Analysis of Child-Pugh Score From Baseline to 1 Year Follow-up|"Assessment of the efficacy of human fetal liver progenitor cell transplantation on Child-Pugh score.
The Child-Pugh (CP) classification is a scoring system used for the classification of the severity of cirrhosis. It includes three continuous variables (bilirubin, albumin and INR) and two discrete variables (ascites and encephalopathy). Each variable is scored 1-3 with 3 indicating most severe derangement. The determination of CP score may range from 5 to 15 and the final score allows to categorize patients in Child–Pugh A (5–6 points), B (7–9 points) and C (10–15 points). The highest is the score the sickest is the patient."|Baseline and 1 year Follow-up|Baseline Child-Pugh score vs Follow-up||units on a scale||Standard Deviation|Mean
806400|NCT01013194|Primary|Patient Survival|Assessment of treated and control patients survival at 1 year follow-up|1 year|||participants|||Number
806871|NCT01017237|Primary|Amnesia: Lack of Recall One Day After Surgery of The Picture That Was Shown Following Dexmedetomidine Infusion Plus Midazolam.|Inability to recall picture shown at this time indicates presence of amnesia on the day following surgery.|One day after surgery|per protocol||percentage of patients|||Number
806404|NCT01013597|Secondary|Toxicity of LBH589|Most frequent toxicities at least possibly related to panobinostat, grades 2-4 (grading based on NCI common terminology criteria for adverse events CTCAE version 3). Toxicities were collected from the time the patient provided informed consent until 4 weeks after the patient stopped LBH589.|Every 4 weeks, up to 5 years|||participants|||Number
806405|NCT01013597|Secondary|Impact of LBH589 on Tumor Markers for Thyroid Cancer|Change in serum Thyroglobulin level from baseline to end of treatment. Treatment continued until either extraordinary medical circumstances, disease progression, toxicity, subject withdrawal, or death. At the time subjects came off of study treatment for one of the reasons already listed, a sample was collected for tumor markers.|Baseline and end of treatment, up to 1 year|||ng/mL||Standard Deviation|Mean
806406|NCT01013597|Secondary|Overall Survival|For a given patient, overall survival (OS) is defined as the number of days from the day of first LBH589 administration until the patient’s death. If a patient was alive at the time of analysis, then the patient’s data is censored at the date of the last available evaluation.Survival was assessed every three months until death or final data analysis, whichever occurred first.|Every 3 months up to 5 years|||months||95% Confidence Interval|Median
806407|NCT01013597|Secondary|Time to Progression of Thyroid Cancer|Progression is defined using the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Time to progression is defined as the number of days from the day of first LBH589 administration to the day the patient experienced an event of disease progression or death, whichever came first. Progression was assessed every 3 months until death or up to 5 years, whichever occurred first.|Every 3 months until progression up to 5 years|||months||95% Confidence Interval|Median
806408|NCT01013597|Secondary|Protein Expression Patterns of Notch1 in Thyroid Tissue Samples.||End of study|Notch1 protein expression was not measured due to lack of efficiency of study intervention|||||
806409|NCT01013597|Primary|Tumor Response Rate to LBH589.|"per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v.1.0) for target lesions and assessed by CT/MRI: Response includes Complete Response (CR, disappearance of all target lesions), or Partial Response (PR, >=30% decrease in the sum of the longest diameter of target lesions). No Response includes Stable Disease (SD, neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease), and Progressive Disease (PD, at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s).)"|Every 8 weeks.|||participants|||Number
806410|NCT01013701|Secondary|To Evaluate the Efficacy and Safety of Once Daily Nasal Steroid Therapy With Fluticasone Furoate Nasal Spray in Suppressing the Signs of Recurrence of Nasal Polyps Over the Course of 16 Weeks.||18 weeks|No data was collected/is available for the study as it was terminated prematurely and the PI has since left the institution.|||||
806411|NCT01013701|Primary|To Evaluate the Effect of Once Daily Nasal Steroid Therapy With Fluticasone Furoate Nasal Spray (110 mcg/Day) in Suppressing Nasal Polyp-induced Symptoms Over the Course of 16 Weeks in Patients Presenting to the Clinic With Active Nasal Polypoid Disease.||18 weeks|The PI has left the institution and neither he, nor the data if any, is available. All information provided has been obtained from the Johns Hopkins University School of Medicine Institutional Review Board.|||||
806412|NCT01013740|Secondary|Number of Participants With Grade 4 and Grade 5 Adverse Events (AE)|An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Grades: 0 = no AE or within normal limits; 1 = mild AE; 2 = moderate AE; 3 = severe and undesirable AE; 4 = life-threatening or disabling AE; 5 = death related to AE.|From randomization until disease progression, death, or discontinuation from the study (average of 55 study weeks)|Safety Population: participants who received at least one dose of study medication, based on the actual treatment received||participants|||Number
806413|NCT01013740|Secondary|Maximum Concentration (Cmax) for Vinorelbine|Cmax is defined as the maximum observed plasma or serum concentration after administration of the drug. PK parameters were to be assessed in an optional sub-study. No participants were enrolled in this optional sub-study; thus, no PK data are available.|Days 1 and 8; 0 to 24 hours post-dose||||||
806414|NCT01013740|Secondary|Area Under the Concentration-time Curve Over the Dosing Interval (AUC-tau) for Vinorelbine|AUC-tau is defined as the area under the concentration-time curve over a dosing interval at steady state, where tau is the length of the dosing interval. The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. Pharmacokinetic (PK) parameters were to be assessed in an optional sub-study. No participants were enrolled in this optional sub-study; thus, no PK data are available.|Days 1 and 8; 0 to 24 hours post-dose||||||
806415|NCT01013740|Secondary|Number of Participants With Clinical Benefit (CB) in the Randomized Phase|CB is defined as the the number of participants achieving either a confirmed CR or PR or having stable disease (SD) for at least 24 weeks (i.e., approximately 6 months). CR=the disappearance of all TLs. PR=a >=30% decrease in the sum of the LD of TLs, taking as a reference the Baseline sum LD. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD=at least a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of >=1 new lesion). Participants with unknown or missing responses were treated as non-responders.|From randomization until disease progression, death, or discontinuation from the study (average of 27 study weeks)|ITT Population||participants|||Number
806416|NCT01013740|Secondary|Time to Response in the Randomized Phase|Time to response is defined as the time from randomization until the first documented evidence of CR (the disappearance of all TLs) or PR (a >=30% decrease in the sum of the LD of the TLs, taking as a reference the basline sum LD) (whichever status is recorded first). When tumor response was confirmed at a repeat assessment, the time to response was taken to be the first time that the response was observed.|From randomization until the time of the first documented confirmed CR or PR (average of 27 study weeks)|ITT Population. Only participants with a confirmed CR or PR were assessed for time to response.||weeks||95% Confidence Interval|Median
806872|NCT01017237|Primary|Amnesia: Lack of Picture Recall Following Dexmedetomidine Infusion Plus Midazolam.|Percentage of patients unable to recall picture|Day of Surgery prior to discharge|Per protocol||percentage of patients|||Number
806417|NCT01013740|Secondary|Duration of Response (DOR) in the Randomized Phase|DOR is defined as the time from the first documented evidence of response (CR or PR) until the first documented sign of disease progression (a >=20% increase in the sum of the LD of TLs, taking as reference the smallest sum LD recorded since the treatment started or the appearance of >=1 new lesion) or death, if sooner. CR=the disappearance of all TLs. PR=a >=30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD.|From the time of the first documented confirmed complete or partial response until disease progression or death, if sooner (average of 27 study weeks)|ITT Population. Only participants with a confirmed CR or PR were assessed for duration of response.||months||95% Confidence Interval|Median
806418|NCT01013740|Secondary|Overall Survival (OS)|OS is defined as the time from randomization to the date of death due to any cause. Participants who had not died were censored at the date of the last adequate tumor assessment at the time of the cut-off.|From the date of randomization until death (average of 55 study weeks)|ITT Population||months||95% Confidence Interval|Median
806419|NCT01013740|Secondary|Number of Participants With Overall Response (OR), as Assessed by the Investigator in the Randomized Phase|OR is defined as the number of participants achieving either a confirmed complete response (CR: the disappearance of all target lesions [TLs]) or partial response (PR: a >=30% decrease in the sum of the longest diameter [LD] of the TLs, taking as reference the baseline sum LD) as assessed by the investigator as the best OR.|From randomization until disease progression, death, or discontinuation from the study (average of 27 study weeks)|ITT Population||participants|||Number
806420|NCT01013740|Primary|Progression Free Survival (PFS) in the Randomized Phase|PFS is defined as the time from randomization until the earliest date of disease progression (PD) or death due to any cause, if sooner. PD is defined as at least a 20 % increase in the sum of the longest diameter (LD) of target lesions, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of >=1 new lesion.|From randomization until disease progression, death, or discontinuation from the study (average of 27 study weeks)|ITT Population: participants who were randomized to study treatment, regardless of whether they actually received study medication||months||95% Confidence Interval|Median
806421|NCT01013753|Secondary|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG|Clinical relevant abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.|4 weeks|Treated Set||Participants|||Number
806422|NCT01013753|Secondary|Potassium 3 Hours Post-dose|Effect on potassium evaluated 3 hours post-dose. Analysis is based on the log of the potassium values. For the geometric means, the results were back-transformed to the original scale.|4 weeks|Treated set||mmol/L||95% Confidence Interval|Geometric Mean
806423|NCT01013753|Secondary|Potassium 1 Hour Post-dose|Effect on potassium evaluated 1 hour post-dose. Analysis is based on the log of the potassium values. For the geometric means, the results were back-transformed to the original scale.|4 weeks|Treated set||mmol/L||95% Confidence Interval|Geometric Mean
806424|NCT01013753|Secondary|Potassium 1 Hour Pre-dose|Effect on potassium evaluated 1 hour pre-dose. Analysis is based on the log of the potassium values. For the geometric means, the results were back-transformed to the original scale.|4 weeks|Treated set||mmol/L||95% Confidence Interval|Geometric Mean
806425|NCT01013753|Secondary|Total Asthma Control Questionnaire (ACQ) Score|Control of asthma as assessed by the ACQ at the end of each 4-week treatment period.The ACQ contains 7 questions, each question has a 7 point scale from 0 (no symptoms) till 6 (highest intensity). Total score was defined as the sum of all items divided by the number of items.|4 weeks|FAS including all patients who contributed data for this endpoint.||units on a scale||Standard Error|Mean
806426|NCT01013753|Secondary|Total Asthma Quality of Life Questionnaire (AQLQ(s)) Score|Total score from the Standardised Asthma Quality of Life Questionnaire (AQLQ (s)) at the end of each 4 week treatment period. The AQLQ(s) contains 32 questions, each question has a 7 point scale from 1 (highest intensity) till 7 (no symptoms). Total score was defined as the sum of all items divided by the number of items.|4 weeks|FAS including all patients who contributed data for this endpoint.||units on a scale||Standard Error|Mean
806427|NCT01013753|Secondary|Number of Patients Categorized by Worst Asthma Nighttime Symptoms (Overall)|Assessed by patients at home using the AM2+ device after the first 2 weeks of each period of randomised treatment.|2-4 weeks|FAS including all patients who contributed data for this endpoint.||Number of patients|||Number
806428|NCT01013753|Secondary|Number of Patients Categorized by Worst Asthma Daytime Symptoms (Overall)|Assessed by patients at home using the AM2+ device after the first 2 weeks of each period of randomised treatment.|2-4 weeks|FAS including all patients who contributed data for this endpoint.||Number of patients|||Number
806429|NCT01013753|Secondary|Number of Patients Categorized by Highest Number of Night Time Awakenings (Overall)|Assessed by patients at home using the AM2+ device after the first 2 weeks of each period of randomised treatment.|2-4 weeks|FAS including all patients who contributed data for this endpoint.||Number of patients|||Number
806430|NCT01013753|Secondary|Percentage of Asthma Symptom Free Days|Percentage of asthma-symptom free days after the first 2 weeks of each treatment period was calculated as the number of symptom-free days divided by the number of days on treatment multiplied by 100. A symptom-free day was defined as a day in which no asthma symptoms were recorded, no rescue medication was recorded, activities during the day were not at all limited due to asthma, no shortness of breath during the day was recorded, no wheezing or coughing during the day and no night-time awakenings due to asthma were recorded. Assessed by patients at home using the AM2+ device.|2-4 weeks|FAS including all patients who contributed data for this endpoint.||Percentage of asthma symptom free days||Standard Error|Mean
806431|NCT01013753|Secondary|Mean Number of Puffs of Rescue Medication During the Whole Day|Mean of daily use of salbutamol (albuterol) rescue medication as needed during the entire study period. Assessed by patients at home using the AM2+ device (overall means obtained during each period of randomised treatment excluding the data of the first 2 weeks will be compared). Means are adjusted for treatment, period, patient and study baseline.|2-4 weeks|FAS including all patients who contributed data for this endpoint.||Number of Puffs||Standard Error|Mean
806432|NCT01013753|Secondary|Mean Pre-dose Evening FEV1 (FEV1 p.m.)|FEV1 p.m. was measured by patients at home using the AM2+ device (overall means obtained during each period of randomised treatment excluding the data of the first 2 weeks will be compared). Means are adjusted for treatment, period, patient and study baseline.|2-4 weeks|FAS including all patients who contributed data for this endpoint.||L||Standard Error|Mean
806433|NCT01013753|Secondary|Mean Pre-dose Morning FEV1 (FEV1 a.m.)|FEV1 a.m. was measured by patients at home using the AM2+ device (overall means obtained during each period of randomised treatment excluding the data of the first 2 weeks will be compared). Means are adjusted for treatment, period, patient and study baseline.|2-4 weeks|FAS including all patients who contributed data for this endpoint.||L||Standard Error|Mean
806434|NCT01013753|Secondary|PEF Daily Variability|PEF daily variability was assessed by patients at home using the AM2+ device (overall means obtained during each period of randomised treatment excluding the data of the first 2 weeks will be compared). PEF daily variability is the absolute difference between the morning and the evening PEF value divided by the mean of these two values, expressed as a percent. Means are adjusted for treatment, period, patient and study baseline.|2-4 weeks|FAS including all patients who contributed data for this endpoint.||Percentage||Standard Error|Mean
806435|NCT01013753|Secondary|Mean Pre-dose Evening PEF (PEF p.m.)|PEF p.m. was measured by patients at home using the AM2+ device (overall means obtained during each period of randomised treatment excluding the data of the first 2 weeks will be compared). Means are adjusted for treatment, period, patient and study baseline.|2-4 weeks|FAS including all patients who contributed data for this endpoint.||Liter/min||Standard Error|Mean
806436|NCT01013753|Secondary|Mean Pre-dose Morning PEF (PEF a.m.)|PEF a.m. was measured by patients at home using the AM2+ device (overall means obtained during each period of randomised treatment excluding the data of the first 2 weeks will be compared). Means are adjusted for treatment, period, patient and study baseline.|2-4 weeks|FAS including all patients who contributed data for this endpoint.||Liter/min||Standard Error|Mean
806437|NCT01013753|Secondary|Trough PEF Response|Response was defined as change from baseline. Study baseline PEF was defined as the mean of the available pre-dose PEF values at the randomisation visit. Trough values were defined as the mean of 2 FEV1 values performed at the planned timepoints 23h and 23h 50min related to evening trial-drug inhalation at the end of each 4 week period of randomised treatment. Means are adjusted for treatment, period, patient and study baseline.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 23 h, and 23 h 50 min related to evening dose after 4 weeks|FAS||Liter/sec||Standard Error|Mean
806438|NCT01013753|Secondary|Peak PEF Within 24 Hours Post-dose Response|Response was defined as change from baseline. Study baseline PEF was defined as the mean of the available pre-dose PEF values at the randomisation visit. Peak PEF within 24 hours post-dose measured following the evening trial drug inhalation at the end of each 4 week period of randomised treatment. Means are adjusted for treatment, period, patient and study baseline.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks|FAS||Liter/sec||Standard Error|Mean
806439|NCT01013753|Secondary|Peak Expiratory Flow (PEF) Area Under Curve 0-24 Hours (AUC 0-24h) Response|Response was defined as change from baseline. Study baseline PEF was defined as the mean of the available pre-dose PEF values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. PEF AUC 0-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres/seconds.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1h, -10 mins, 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks|FAS||Liter/sec||Standard Error|Mean
806440|NCT01013753|Secondary|PEF Area Under Curve 12-24 Hours (AUC 12-24h) Response|Response was defined as change from baseline. Study baseline PEF was defined as the mean of the available pre-dose PEF values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. PEF AUC 12-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres/seconds.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks|FAS||Liter/sec||Standard Error|Mean
806441|NCT01013753|Secondary|Peak Expiratory Flow (PEF) Area Under Curve 0-12 Hours (AUC 0-12h) Response|Response was defined as change from baseline. Study baseline PEF was defined as the mean of the available pre-dose PEF values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. PEF AUC 0-12h was calculated using the trapezoidal rule, divided by the observation time to report in litres/seconds.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 mins, 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min related to evening dose after 4 weeks|FAS||Liter/sec||Standard Error|Mean
806442|NCT01013753|Secondary|Trough FVC Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Trough values were defined as the mean of 2 FEV1 values performed at the planned timepoints 23h and 23h 50min related to evening trial-drug inhalation at the end of each 4 week period of randomised treatment. Means are adjusted for treatment, period, patient and study baseline.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 23 h, and 23 h 50 min related to evening dose after 4 weeks|FAS||Liter||Standard Error|Mean
806443|NCT01013753|Secondary|Peak FVC Within 24 Hours Post-dose Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Peak FVC within 24 hours post dose measured following the trial drug inhalation at the end of each 4 week period of randomised treatment. Means are adjusted for treatment, period, patient and study baseline.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks|FAS||Liter||Standard Error|Mean
806444|NCT01013753|Secondary|FVC Area Under Curve 0-24 Hours (AUC 0-24h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FVC AUC 0-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 min, 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks|FAS||Liter||Standard Error|Mean
806873|NCT01017237|Primary|Amnesia: Lack of Recall One Day After Surgery of The Picture That Was Shown Prior to Sedation.|Lack of recall of picture shown indicates presence of amnesia the day following surgery.|One day after surgery|Per protocol||percentage of patients|||Number
806445|NCT01013753|Secondary|FVC Area Under Curve 12-24 Hours (AUC 12-24h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FVC AUC 12-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks|FAS||Liter||Standard Error|Mean
806446|NCT01013753|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-12 Hours (AUC 0-12h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FVC AUC 0-12h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 mins, 30 min, 60 min, 2 h , 3 h, 4 h, 11 h 50 min related to evening dose after 4 weeks|FAS||Liter||Standard Error|Mean
806447|NCT01013753|Secondary|Trough FEV1 Response|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Trough values were defined as the mean of 2 FEV1 values performed at the planned timepoints 23h and 23h 50min related to evening trial-drug inhalation at the end of each 4 week period of randomised treatment. Means are adjusted for treatment, period, patient and study baseline.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 23 h, and 23 h 50 min related to evening dose after 4 weeks|FAS||Liter||Standard Error|Mean
806448|NCT01013753|Secondary|Peak FEV1 Within 24 Hours Post-dose Response|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Peak FEV1 within 24 hours post dose measured following the evening trial drug inhalation at the end of each 4 week period of randomised treatment. Means are adjusted for treatment, period, patient and study baseline.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks|FAS||Liter||Standard Error|Mean
806449|NCT01013753|Secondary|FEV1 Area Under Curve 12-24 h (AUC 12-24h) Response at the End of Each Treatment Period|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FEV1 AUC 12-24h was calculated from 12-24 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks|FAS||Liter||Standard Error|Mean
806450|NCT01013753|Secondary|FEV1 Area Under Curve 0-12 h (AUC 0-12h) Response at the End of Each Treatment Period|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FEV1 AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 mins, 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min related to evening dose after 4 weeks|FAS||Liter||Standard Error|Mean
806451|NCT01013753|Primary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-24 Hours (AUC 0-24h) Response at the End of Each Treatment Period|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FEV1 AUC 0-24h was calculated from 0-24 hours post-dose using the trapezoidal rule, divided by the observation time (24h) to report in litres.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 mins, 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks|Full analysis set (FAS). FAS is defined as all patients in the treated set for whom the baseline (pre-dose) value is available, and who have a value for the primary endpoint for at least one crossover period.||Liter||Standard Error|Mean
806452|NCT01013792|Primary|Percent Diabetic Foot Ulcer Area Reduction From Baseline to Last Treatment Visit|A positive value indicates a reduction in area relative to baseline, while a negative value indicates an increase in area relative to baseline (at time of randomization), calculated as [(Baseline - Week 8)/Baseline] x 100%.|up to 8 weeks|All participants that are randomized||percent change of baseline area||Full Range|Median
806453|NCT01013844|Primary|Mean Number of Times Reviewed Skin Self Examination Guidelines Over 4 Months|Behavioral outcome was measured by assessing the number of times that participants reviewed skin self examination guidelines in the last 4 months.|4 months|||Number of times reviewed SSE guidelines||Standard Deviation|Mean
806454|NCT01013844|Primary|Mean Number of Skin Examinations With Partner Over 4 Months|Behavioral outcome was measured by assessing the number of times that participants examined their skin with a partner in the last 4 months.|4 months|||Times examined skin with a partner||Standard Deviation|Mean
806455|NCT01013844|Primary|Mean Number of Skin Examinations Without Partner Over 4 Months|Behavioral outcome was measured by assessing the number of times that participants examined their skin in the last 4 months.|4 months|||Times examined skin by self||Standard Deviation|Mean
806456|NCT01013870|Secondary|Symbol Digit Modalities Test - Written Score|The SDMT is a measure of divided attention, visual scanning and motor speed. This measure involves a coding key consisting of 9 abstract symbols, each paired with a number ranging from 1 to 9. The subject is required to scan the key and write down the number corresponding to each symbol as fast as possible. The number of correct substitution within 90 seconds is recorded. In the written version of the test the subject fills in the numbers that correspond to the symbols. In the oral version the examiner records the numbers spoken by the subject. The score is the number of correctly coded items from 0-110 in 90 seconds. A higher score indicates better performance.|3 months after injury|The analysis population includes all 27 patients in the atorvastatin group who completed the study and the 21 placebo group patients who completed the study plus one lost to follow-up at 6 months but had completed all of the outcome assessments for the primary and secondary outcomes at 3 months (for a total of 22 placebo group patients).||units on a scale||Inter-Quartile Range|Median
806457|NCT01013870|Secondary|Symbol Digit Modalities Test - Oral Score|The SDMT is a measure of divided attention, visual scanning and motor speed. This measure involves a coding key consisting of 9 abstract symbols, each paired with a number ranging from 1 to 9. The subject is required to scan the key and write down the number corresponding to each symbol as fast as possible. The number of correct substitution within 90 seconds is recorded. In the written version of the test the subject fills in the numbers that correspond to the symbols. In the oral version the examiner records the numbers spoken by the subject. The score is the number of correctly coded items from 0-110 in 90 seconds. A higher score indicates better performance.|3 months after injury|The analysis population includes all 27 patients in the atorvastatin group who completed the study and the 21 placebo group patients who completed the study plus one lost to follow-up at 6 months but had completed all of the outcome assessments for the primary and secondary outcomes at 3 months (for a total of 22 placebo group patients).||units on a scale||Inter-Quartile Range|Median
806458|NCT01013870|Secondary|Brief Visuospatial Memory Test - Revised|The BVMT-R is a measure of visuospatial memory. Six equivalent, alternate stimulus forms consist of six geometric figures printed in a 2 x 3 array on separate pages. In three Learning Trials, the subject views the stimulus page for 10 seconds and is asked to draw as many of the figures as possible in their correct location. A Delayed Recall Trial is administered after a 25-minute delay. Last, a Recognition Trial, in which the respondent is asked to identify which of 12 figures were included among the original geometric figures, is administered. Scoring of the immediate and delayed recall are based on the accuracy of the drawings and the location of the figures. For each figure, one point is awarded to each satisfactory domain resulting in a maximum of 12-points per trial.|3 months after injury|The analysis population includes all 27 patients in the atorvastatin group who completed the study and the 21 placebo group patients who completed the study plus one lost to follow-up at 6 months but had completed all of the outcome assessments for the primary and secondary outcomes at 3 months (for a total of 22 placebo group patients).||units on a scale||Inter-Quartile Range|Median
806459|NCT01013870|Secondary|Center for Epidemiological Study Depression Scale|The CES-D is a widely used screening scale for depression, assessing depressive feelings and behaviors occurring in the past week of a patient’s life. The CES-D consists of 20 items, which make up six scales reflecting depressive symptomatology: depressed mood, feelings of guilt and worthlessness, feelings of helplessness and hopelessness, psychomotor retardation, loss of appetite, and sleep disturbance. Each item is scored on a 4-point scale ranging from 0 (rarely/none of the time) to 3 (most/all of the time). Scores for items 4, 8, 12, and 16 are reversed before summing all items to yield a total score, which can range from 0-60. Higher scores indicate more depressive symptoms. (Radloff, LS [1977]. The CES-D Scale: A self-report depression scale for research in the general population. App Psychol Meas, 1, 385-401.)|3 months after injury|The analysis population includes all 27 patients in the atorvastatin group who completed the study and the 21 placebo group patients who completed the study plus one lost to follow-up at 6 months but had completed all of the outcome assessments for the primary and secondary outcomes at 3 months (for a total of 22 placebo group patients).||units on a scale||Inter-Quartile Range|Median
806460|NCT01013870|Secondary|Connor Davidson Resilience Measure|The Connor-Davidson Resilience scale (CD-RISC) has 25 items, each rated on a 5-point scale (0-4), with higher scores reflecting greater resilience. The sum score has a range from 0 to 100. (Conner KM, Davidson JR. Development of a new resilience scale: the Connor-Davidson Resilience Scale [CD-RISC]. Depress Anxiety 18[2]:76-82,2003].|3 months after injury|The analysis population includes all 27 patients in the atorvastatin group who completed the study and the 21 placebo group patients who completed the study plus one lost to follow-up at 6 months but had completed all of the outcome assessments for the primary and secondary outcomes at 3 months (for a total of 22 placebo group patients).||units on a scale||Inter-Quartile Range|Median
806461|NCT01013870|Secondary|Post-traumatic Stress Checklist - Civilian Form|The Post Traumatic Stress Disorder Checklist (PCL) is a 17-item self report measure of the DSM-IV symptoms of PTSD. Respondents rate how much they were “bothered by a symptom” on a 5-point scale ranging from 1 (“not at all”) to 5 (“extremely”). The PCL was scored as a total score (range 17-85), with higher total scores indicating more symptoms. (Weathers, F., Litz, B., Herman, D., Huska, J., & Keane, T. [October 1993]. The PTSD Checklist [PCL]: Reliability, Validity, and Diagnostic Utility. Paper presented at the Annual Convention of the International Society for Traumatic Stress Studies, San Antonio, TX.)|3 months after injury|The analysis population includes all 27 patients in the atorvastatin group who completed the study and the 21 placebo group patients who completed the study plus one lost to follow-up at 6 months but had completed all of the outcome assessments for the primary and secondary outcomes at 3 months (for a total of 22 placebo group patients).||units on a scale||Inter-Quartile Range|Median
806462|NCT01013870|Secondary|Medical Outcome Study Short Form 12 - Physical Score|SF-12 is a self-report questionnaire that assesses functional health and well-being. There are 12 items in 8 subscales, including physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Physical and Mental Health Composite Scores are computed using the scores of the 12 questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. Both Physical and Mental Health Composite Scales combine the 12 items in such a way that they compare to a national norm with a mean score of 50.0 and a standard deviation of 10.0. (Ware, J.E., Jr., Kosinski, M., Turner-Bowker, D.M., Gandek, B. How to Score Version 2 of the SF-12v2® Health Survey [With a Supplement Documenting SF-12® Health Survey] Lincoln, RI: QualityMetric Incorporated, 2002.)|3 months after injury|The analysis population includes all 27 patients in the atorvastatin group who completed the study and the 21 placebo group patients who completed the study plus one lost to follow-up at 6 months but had completed all of the outcome assessments for the primary and secondary outcomes at 3 months (for a total of 22 placebo group patients).||units on a scale||Inter-Quartile Range|Median
806483|NCT01014091|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = incidence of a particular symptom regardless of intensity grade or relationship to vaccinations. Grade 3 pain (children below 6 years of age) = cried when limb was moved/spontaneously painful. Grade 3 pain (children above 6 years of age) = significant pain at rest; pain that prevented normal everyday activities. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.||Subjects|||Number
806463|NCT01013870|Secondary|Medical Outcome Study Short Form 12 - Mental Score|SF-12 is a self-report questionnaire that assesses functional health and well-being. There are 12 items in 8 subscales, including physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Physical and Mental Health Composite Scores are computed using the scores of the 12 questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. Both Physical and Mental Health Composite Scales combine the 12 items in such a way that they compare to a national norm with a mean score of 50.0 and a standard deviation of 10.0. (Ware, J.E., Jr., Kosinski, M., Turner-Bowker, D.M., Gandek, B. How to Score Version 2 of the SF-12v2® Health Survey [With a Supplement Documenting SF-12® Health Survey] Lincoln, RI: QualityMetric Incorporated, 2002.)|3 months|The analysis population includes all 27 patients in the atorvastatin group who completed the study and the 21 placebo group patients who completed the study plus one lost to follow-up at 6 months but had completed all of the outcome assessments for the primary and secondary outcomes at 3 months (for a total of 22 placebo group patients).||units on a scale||Inter-Quartile Range|Median
806464|NCT01013870|Primary|Rivermead Post-Concussion Symptoms Questionnaire, at 3 Months After Injury.|The Rivermead Post-Concussive Symptoms Questionnaire (RPQ) is a 16-item self-report measure of the presence and severity of the 16 most commonly reported post-concussive symptoms found in the literature. The scale compares any current symptoms to pre-injury symptom levels to account for potential symptom exacerbation due to TBI. The range of scores is 0-64. Values for each of the 16 items include 0 (not experienced at all), 1 (no more of a problem than before the injury), 2 (mild problem), 3 (moderate problem), 4 (severe problem). The total score was a summation of symptoms that represented new symptom onset or an exacerbation of a symptom present pre-injury. (King, N.S., Crawford, S., Wenden, F.J., Moss, N.E., & Wade, D.T. [1995]. The Rivermead Post Concussion Symptoms Questionnaire: A Measure of Symptoms Commonly Experiences after Head Injury and its Reliability. Journal of Neurology 242: 587-92.)|3 months after injury|The analysis population includes all 27 patients in the atorvastatin group who completed the study and the 21 placebo group patients who completed the study plus one lost to follow-up at 6 months but had completed all of the outcome assessments for the primary and secondary outcomes at 3 months (for a total of 22 placebo group patients).||units on a scale||Full Range|Median
806465|NCT01013883|Secondary|Admission to Hospital for Any Cause|Number of patients admitted to the hospital will be recorded|During the follow up period of 7 years|||participants|||Number
806466|NCT01013883|Secondary|Cardiovascular Mortality||Patients would be followed up for average of 7years|||participants|||Number
806467|NCT01013883|Primary|All Cause Mortality||Patients would be followed up for average of 7 years|||participants|||Number
806468|NCT01013961|Secondary|Duration of Response|Duration of response is defined to be time from first confirmed CR, PR or clinical CR to progression or to death without documentation of progression. Patients without confirmed CR, PR or clinical CR are censored at time 0. Those without documentation of progression are censored at the date of last disease assessment without progression, unless death occurs within three months following the date last known progression free.|Assessed after 2 cycles of treatment, 2 months after completion of therapy and then yearly up to 5 years|All randomized patients||months||95% Confidence Interval|Median
806469|NCT01013961|Secondary|Time to Response|Time to response is defined to be time from randomization to first confirmed CR, PR or clinical CR. Those without confirmed CR, PR or clinical CR are censored at the date of last disease assessment.|Assessed after 2 cycles of treatment, 2 months after completion of therapy and then yearly up to 5 years|All randomized patients||months||95% Confidence Interval|Median
806470|NCT01013961|Secondary|Progression-free Survival (PFS)|"PFS is defined to be time from randomization to progression (PD) or to death without documentation of progression. For patients without PD, follow-up is censored at the date of last disease assessment without PD, unless death occurs within three months following the date last known progression free.
PD is characterized by at least one of the following:
≥50% increase in the sum of the products of at least 2 lymph nodes on 2 consecutive examinations 2 weeks apart (at least 1 node must be >2 cm). Appearance of new palpable lymph nodes (>1 cm in diameter).
≥50% increase in the size of liver and/or spleen as determined by measurement below the respective costal margin; appearance of palpable hepatomegaly or splenomegaly which was not previously present.
Absolute number of circulating lymphocytes with a count of >5x10^9/L
Transformation to a more aggressive histology"|Assessed after 2 cycles of treatment, 2 months after completion of therapy and then yearly up to 5 years|All randomized patients||months||95% Confidence Interval|Median
806471|NCT01013961|Secondary|Overall Survival (OS)|OS is defined to be time from randomization to death from any cause. Those still alive are censored at the date of last contact.|Assessed after 2 cycles of treatment, 2 months after completion of therapy and then yearly up to 5 years|All randomized patients||months||95% Confidence Interval|Median
806472|NCT01013961|Primary|Proportion of Patients With Overall Response (OR)|"OR is defined as either CR, clinical CR, or partial response (PR) evaluated by NCI-WG96 criteria. CR has been defined in the other primary endpoint.
A clinical CR requires all of the following:
Absence of lymphadenopathy by physical examination
No hepatomegaly or splenomegaly. Spleen and/or liver, if considered enlarged at baseline, should not be palpable, due to disease, on physical exam
Absence of constitutional symptoms
Normal CBC as exhibited by:
A PR requires all the following for ≥2 months:
≥50% decrease in peripheral blood lymphocyte count from baseline
≥50% reduction in lymphadenopathy
≥50% reduction in size of liver and/or spleen
Polymorphonuclear leukocytes ≥1.5x10^9/L or 50% improvement over baseline
Platelets >100x10^9/L or 50% improvement over baseline
Hemoglobin >11.0 gm/dl or 50% improvement over baseline without transfusions
Any constitutional symptoms"|Assessed after 2 cycles of treatment and 2 months after completion of therapy|All randomized patients||proportion of participants||95% Confidence Interval|Number
806484|NCT01014091|Secondary|Geometric Mean Fold Increase (GMFR) for Serum HI Antibody Titer|GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.|At Day 21 and Month 7|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses of study vaccine and for whom assay results were available for antibodies against H1N1 antigen for any blood sample taken up to Month 7 after first vaccine dose.||Fold increase||95% Confidence Interval|Geometric Mean
806874|NCT01017237|Secondary|Respiratory Parameters: Oxyhemoglobin Saturation|Oxyhemoglobin saturation per pulse oximetry|During surgical procedure|per protocol||Percent oxyhemoglobin saturation||Standard Deviation|Mean
806473|NCT01013961|Primary|Proportion of Patients With Complete Response (CR)|"Response was evaluated using NCI-WG96 criteria.
A CR requires all of the following for >= 2 months:
Absence of lymphadenopathy > 1 cm in diameter by physical examination
No hepatomegaly or splenomegaly on physical exam
No constitutional symptoms
Normal complete blood count (CBC)
Patients achieving a clinical CR with negative CT scan after 2 cycles of therapy are re-evaluated using immunohistochemical examination of bone marrow biopsy for residual CLL cells. Patients with no evidence of residual disease and no radiological evidence of residual CLL on CT scan of chest-abdomen-pelvis and no clinical evidence of CLL on clinical evaluation after completion of 2 cycles of therapy will be considered to have a CR with no evidence of residual disease"|Assessed after 2 cycles of treatment and 2 months after completion of therapy|All randomized patients||proportion of participants||95% Confidence Interval|Number
806474|NCT01014013|Secondary|Clinical Response Assessment Profile|The difference in favorable clinical response rates between the 2 treatment groups (MK0826 response rate minus ceftriaxone response rate) was assessed|5 to 9 days post-therapy|Secondary efficacy analysis was done for 137 evaluable patients (66 patients from MK0826 and 71 patients from Ceftriaxone)||Participants|||Number
806475|NCT01014013|Primary|The Number of Patients Who Experience Any Drug-related Adverse Experiences Leading to Discontinuation of Parenteral Study Drug and the Number of Patients With Any Drug-related Serious Adverse Experiences (AEs) During Parenteral Treatment|Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences, physical examination, vital signs, and laboratory results during parenteral therapy. As per the primary safety hypothesis, it was expected that, at the end of the parenteral therapy only, MK0826 would be similar to ceftriaxone with respect to the proportion of patients with any drug-related clinical or laboratory adverse experiences leading to discontinuation of study drug and also with respect to the proportion of patients with any serious drug-related adverse experiences.|Adverse experiences that occurred during the study parenteral therapy period were analyzed. The period of parenteral therapy is from 3 days up to 14 days|Safety Analysis has been done 267 patients who received at least 1 dose of parenteral therapy (132 patients from MK0826 and 135 patients from Ceftriaxone)||Participants|||Number
806476|NCT01014013|Primary|Microbiological Response Assessment Profile|The difference in favorable microbiological response rates between the 2 treatment groups (MK0826 response rate minus ceftriaxone response rate) was assessed|5 to 9 days post-therapy|Primary efficacy analysis was done for 137 evaluable patients (66 patients from MK0826 and 71 patients from Ceftriaxone)||Participants|||Number
806477|NCT01014091|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Month 0 to Month 12)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.||Subjects|||Number
806478|NCT01014091|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|Within the 42-day (Days 0-41) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.||Subjects|||Number
806479|NCT01014091|Secondary|Number of Subjects With Adverse Events of Specific Interest (AESIs)/Potential Immune-mediated Disease (pIMDs)|Adverse events of specific interest (AESI) were defined as AEs including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration. Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|During the entire study period (from Month 0 up to Month 12)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.||Subjects|||Number
806480|NCT01014091|Secondary|Number of Subjects With Any Medically-attended Events (MAEs)|MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.|During the entire study period (from Month 0 up to Month 12)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.||Subjects|||Number
806481|NCT01014091|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal, headache and temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = incidence of a particular symptom regardless of intensity grade or relationship to vaccinations. Grade 3 = symptom which prevented normal everyday activity. Related = symptom assessed by the investigator as causally related to the vaccination. Grade 3 fever = fever > 39.0 °C.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.||Subjects|||Number
806482|NCT01014091|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = incidence of a particular symptom regardless of intensity grade or relationship to vaccinations. Grade 3 drowsiness = drowsiness which prevented normal everyday activities. Grade 3 irritability = crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as causally related to the vaccination|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.||Subjects|||Number
806485|NCT01014091|Secondary|Number of Seroprotected Subjects for HI Antibodies|A seroprotected subject was defined as a vaccinated subject with a serum HI titer ≥ 1:40, which is usually accepted as indicating protection. The flu strain assessed was Flu A/CAL/7/09.|At Day 0, Day 21 and Month 7|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses of study vaccine and for whom assay results were available for antibodies against H1N1 antigen for any blood sample taken up to Month 7 after first vaccine dose.||Subjects|||Number
806486|NCT01014091|Secondary|Number of Seroconverted Subjects in Terms of HI Antibodies|Seroconversion (SCR) was defined as: For initially seronegative subjects (pre-vaccination titer below < 1:10), a post-vaccination titer ≥ 1:40. For initially seropositive subjects (pre-vaccination titer ≥ 1:10), at least a 4-fold increase in post-vaccination titer. The flu strain assessed was Flu A/CAL/7/09.|At Day 21 and Month 7|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses of study vaccine and for whom assay results were available for antibodies against H1N1 antigen for any blood sample taken up to Month 7 after first vaccine dose.||Subjects|||Number
806487|NCT01014091|Secondary|HI Antibody Titers Against Vaccine H1N1 Antigen|Humoral immune response in terms of vaccine H1N1 haemagglutination inhibition (HI) antibodies against A/California/7/2009 (H1N1)v-like virus (Flu A/CAL/7/09) has been assessed. Antibody titers were presented as geometric mean titers (GMTs).|At Day 0, Day 21 and Month 7|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses of study vaccine and for whom assay results were available for antibodies against H1N1 antigen for any blood sample taken up to Month 7 after first vaccine dose.||Titers||95% Confidence Interval|Geometric Mean
806488|NCT01014091|Secondary|Number of Seropositive Subjects for HI Antibodies|A seropositive subject was defined as a subject with a serum HI titer equal to or above (≥) 1:10. The flu strain assessed was Flu A/CAL/7/09.|At Day 0, Day 21 and Month 7|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses of study vaccine and for whom assay results were available for antibodies against H1N1 antigen for any blood sample taken up to Month 7 after first vaccine dose.||Subjects|||Number
806489|NCT01014091|Primary|Geometric Mean Fold Increase (GMFR) for Serum HI Antibody Titer|GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.|At Day 42|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses of study vaccine and for whom assay results were available for antibodies against H1N1 antigen for any blood sample taken up to Month 7 after first vaccine dose.||Fold increase||95% Confidence Interval|Geometric Mean
806490|NCT01014091|Primary|Number of Seroprotected Subjects for HI Antibodies|A seroprotected subject was defined as a vaccinated subject with a serum HI titer ≥ 1:40, which is usually accepted as indicating protection. The flu strain assessed was Flu A/CAL/7/09.|At Day 42|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses of study vaccine and for whom assay results were available for antibodies against H1N1 antigen for any blood sample taken up to Month 7 after first vaccine dose.||Subjects|||Number
806491|NCT01014091|Primary|Number of Seroconverted Subjects in Terms of HI Antibodies|Seroconversion (SCR) was defined as: For initially seronegative subjects [pre-vaccination titer below (<) 1:10], a post-vaccination titer ≥ 1:40. For initially seropositive subjects (pre-vaccination titer ≥ 1:10), at least a 4-fold increase in post-vaccination titer. The flu strain assessed was Flu A/CAL/7/09.|At Day 42|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses of study vaccine and for whom assay results were available for antibodies against H1N1 antigen for any blood sample taken up to Month 7 after first vaccine dose.||Subjects|||Number
806492|NCT01014091|Primary|Number of Seropositive Subjects for HI Antibodies|A seropositive subject was defined as a subject with a serum HI titer equal to or above (≥) 1:10. The flu strain assessed was Flu A/CAL/7/09.|At Day 42|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses of study vaccine and for whom assay results were available for antibodies against H1N1 antigen for any blood sample taken up to Month 7 after first vaccine dose.||Subjects|||Number
806493|NCT01014091|Primary|Haemagglutination Inhibition (HI) Antibody Titers Against Vaccine H1N1 Antigen|Humoral immune response in terms of vaccine H1N1 haemagglutination inhibition (HI) antibodies against A/California/7/2009 (H1N1)v-like virus (Flu A/CAL/7/09) has been assessed. Antibody titers were presented as geometric mean titers (GMTs).|At Day 42|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who received 2 doses of study vaccine and for whom assay results were available for antibodies against H1N1 antigen for any blood sample taken up to Month 7 after first vaccine dose.||Titers||95% Confidence Interval|Geometric Mean
806494|NCT01014143|Primary|Plaque Index|Plaque scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque,3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|Four days|per protocol. 2 subjects missed appointments and did not complete two of the study treatment periods.||Units on a scale||Standard Deviation|Mean
806495|NCT01014169|Secondary|Maternal Practice Related to Correct Car Seat Use|Correct car seat use by all subjects who use cars was defined as placing the car seat in the back seat facing backwards and using the car seat every time the infant travels by car. The number reported is the number who report using the car seat correctly.|two days after discharge|||participants with correct car seat use|||Number
806496|NCT01014169|Secondary|Maternal Practice Related to Breastfeeding Initiation|This measure assesses maternal report of breastfeeding. The number analyzed is the number who reported any breastfeeding.|two days after discharge|||participants who report breastfeeding|||Number
806497|NCT01014169|Primary|The Primary Outcome of Interest is Maternal Practice Related to Supine Infant Sleep Position.|This measure assesses maternal report of placing the infant on the back to sleep (supine sleep position) as opposed to putting the infant on its side or stomach.|two days after discharge|||participants who report supine position|||Number
806755|NCT01016678|Primary|Percentage of Migraine Attacks With Sustained Pain Free Response From 2 to 24 Hours Post-Dose|All data was collected and measured from self-reported patient diaries|3 years|Patients who treated with study drug and were pain free at 2 hours and then continued to be pain free through 24 hours||percentage of attacks|Participants||Number
806498|NCT01014208|Secondary|Time to Engraftment After High-dose Therapy (HDT)/ASCT|Engraftment is defined as 1) three consecutive days when the ANC is ≥0.5x109/L and 2) an unsupported platelet count of ≥20x109/L, and the engraftment date is the date that this occurs. If engraftment was not achieved by Day 42 or the last observation, engraftment was deemed to be a failure, and censoring took place at Day 42 or at the last observation.|From ASCT up to 42 days post-ASCT (Baseline up to approximately 4.5 months)|Safety population. Only participants completing HDT/ASCT are included.||Days||95% Confidence Interval|Median
806499|NCT01014208|Secondary|Time to Neutrophil and Platelet Recovery After Each Cycle of Salvage Chemotherapy|Neutrophil (absolute neutrophil count [ANC]) recovery is defined as ANC >=0.5*10^9/Liter and increasing, and platelet (PLT) recovery is defined as PLT >=10*10^9/Liter and increasing. For each cycle, time to ANC recovery is defined as the time from the first dose to the first ANC >=0.5*10^9/Liter and increasing after the nadir in the cycle. For each cycle, time to PLT recovery is defined as the time from the first dose to the first PLT >=10*10^9/L and increasing after the nadir in the cycle.|From the start of each cycle for a maximum of 5 weeks per cycle (assessed during treatment period of Baseline up to approximately 3 months)|Safety Population. Only those participants available for analysis in the given cycle were assessed.||days||95% Confidence Interval|Median
806500|NCT01014208|Secondary|Change From Baseline in the Functional Assessment of Cancer Therapy Lymphoma Trial Outcome Index (FACT-Lym TOI) Total Score During Treatment|"The FACT-Lym TOI is a measure that combines the FACT-Lym subscale (15 items; responses to each item range from 0, Not at all to 4, Very much) with two domains taken from the FACT-G (responses to each item range from Not at all  to Very much): Physical Well-being (7 items: lack of energy, nausea, meeting family needs, pain, side effects, feels ill, spends time in bed) and Functional Well-being (7 items: ability to work, work fulfilment, ability to enjoy life, illness acceptance, ability to sleep well, enjoying things done for fun, satisfaction with quality of life). This index is designed to be sensitive to changes in treatment regimens. The total FACT-Lym TOI score ranges from 0 to 116; higher scores indicate a better patient-reported outcome/quality of life. Participants were asked to think back over the past week when responding to the items."|Baseline and the end of the treatment period (until approximately 4 to 6 weeks following Cycle 3 [assessed up to 3 months])|ITT Population. Only those participants who provided data were assessed.||scores on a scale||Standard Error|Mean
806501|NCT01014208|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) During Treatment|"The FACT-G was developed by the Functional Assessment of Chronic Illness Therapy (FACIT) group for use in adults in a wide range of oncology clinical trial populations. The 27 items of the FACT-G are scored in the following domains: Physical Well-being (7 items), Social/Family Wellbeing (7 items), Emotional Well-being (6 items), and Functional Well-being (7 items). Participants responded to the items on a five-point Likert scale ranging from 0, Not at all to 4, Very much. The total score ranges from 0 to 108; higher scores indicate a better patient-reported outcome/quality of life. Participants were asked to think back over the past week when responding to the items."|Baseline and the end of the treatment period (until approximately 4 to 6 weeks following Cycle 3 [assessed up to 3 months])|ITT Population. Only those participants who provided data were assessed.||scores on a scale||Standard Error|Mean
806502|NCT01014208|Secondary|Number of Participants Completing Autologous Stem Cell Transplant (ASCT)|The number of participants who completed ASCT is reported.|Approximately 4 to 6 weeks following Cycle 3 (assessed up to 3 months)|ITT Population||Participants|||Number
806503|NCT01014208|Secondary|Number of Participants With the Ability to Mobilize at Least 2 Million Cluster of Differentiation (CD)34+ Cells Per Kilogram From Peripheral Blood|Stem cell mobilization is the process of stimulating the hematopoietic stem cells (CD34+) to move out of the bone marrow and into the bloodstream, where they can be collected via a process called apheresis. Successful mobilization is defined as the collection of >2*10^6 CD34+ cells/kg. Only those participants, who commenced harvest, following the administration of rituximab or ofatumumab in combination with DHAP combination chemotherapy, were assessed. The number of participants with adequate harvest of CD34+ stem cells (at least 2*10^6 CD34+ cells/kg) after dosing of salvage therapy in Cycle 2 and Cycle 3 was analyzed.|During Cycles 2 and/or 3 (Weeks 4-9)|ITT Population. Only participants commencing leukapheresis are included.||Participants|||Number
806504|NCT01014208|Secondary|Overall Survival (OS)|OS is defined as the time from randomization to death due to any cause. Participants who were still alive by the end of the study were censored.|From randomization to death due to any cause (assessed for up to 5 years)|ITT Population||Months||95% Confidence Interval|Median
806505|NCT01014208|Secondary|Event-free Survival|Event-free survival is defined as the time from randomization to progressive disease (PD; disease whose course is growth, or spread of the disease), stable disease (SD; failure to attain the criteria needed for a CR or PR and no fulfillment of the criteria for PD) after completion of 2 cycles of therapy, commencement of a new treatment for diffuse large B cell lymphoma (DLBCL) (e.g., radiotherapy), or death from any cause, whichever occurs first. Disease progression was based on the assessments of independent reviewers for the disease under study. Disease progression was based on imaging data via the Revised Response Criteria for Malignant Lymphoma (RRCML).|From randomization to progressive disease, stable disease after completion of 2 cycles of therapy, commencement of a new treatment for DLBCL, or death due to any cause (assessed for up to 5 years)|ITT Population||Months||95% Confidence Interval|Median
806506|NCT01014208|Secondary|Number of Participants With Overall Response (OR) and Complete Response (CR) Three Months After Autologous Stem Cell Transplant|OR is defined as the number of participants achieving either a complete response (CR) or a partial response (PR). CR is defined as the complete disappearance of all detectable clinical evidence of disease and disease-related symptoms. PR is defined as at least a 50% decrease from Baseline in the sum of the product of the diameters of target lesions. RRCML was used to assess CR and PR.|At 3 months after completion of autologous stem cell transplantation (ASCT) (assessed up to 6 months)|ITT Population. Only participants completing HDT/ASCT are included.||Participants|||Number
806507|NCT01014208|Secondary|Number of Participants With Overall Response (OR) and Complete Response (CR) After Salvage Chemoimmunotherapy|OR is defined as the number of participants achieving either a complete response (CR) or a partial response (PR). CR is defined as the complete disappearance of all detectable clinical evidence of disease and disease-related symptoms. PR is defined as at least a 50% decrease from Baseline in the sum of the product of the diameters of target lesions. RRCML was used to assess CR and PR.|At completion of up to 3 cycles of salvage chemoimmunotherapy (assessed up to 9 weeks)|ITT Population||Participants|||Number
806508|NCT01014208|Primary|Progression-free Survival as Assessed by Independent Reviewers|Progression-free survival is defined as the interval of time from the randomization date until the date of stable disease (SD; failure to attain the criteria needed for a CR or PR and no fulfillment of the criteria for progressive disease [PD]) after two cycles of salvage chemotherapy, progression, or death, whichever occurs first. Disease progression was based on the assessments of independent reviewers for the disease under study. Disease progression was based on imaging data via the Revised Response Criteria for Malignant Lymphoma (RRCML).|From randomization until the date of stable disease after two cycles of salvage chemotherapy, progression, or death (assessed for up to 5 years)|Intent-to-Treat (ITT) Population: all participants who were randomized and commenced study therapy (at least one dose of a study drug)||Months||95% Confidence Interval|Median
806509|NCT01014351|Secondary|Objective Response Rate (ORR)|Objective Response Rate (ORR) is defined as the Percentage of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|18 months|||percentage of patients|||Number
806510|NCT01014351|Secondary|Overall Survival (OS)|Overall survival (OS) is defined as the time from randomization until death from any cause.|18 months|||Months||95% Confidence Interval|Median
806511|NCT01014351|Primary|Progression-free Survival (PFS)|Progression-free survival (PFS) is defined as the time from randomization until objective tumor progression (PD) or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|18 months|||Months||95% Confidence Interval|Median
806512|NCT01014442|Secondary|Percentage of Participants With Opportunistic Infections|Opportunistic infections included all infections which occurred due to aspergillus, candida, pneumocystis, cryptococcus, listeria, herpes zoster, herpes simplex, cytomegalovirus pathogens.|Up to Day 90|Safety Population||percentage of participants|||Number
806513|NCT01014442|Secondary|Change From Baseline in T-Cell Phenotype|Reported values are change in the T-cell phenotype status from baseline to Day 20 and 90 for cluster of differentiation (CD) 3, CD19, CD4, CD4CD25, CD28, CD45RA, CD45RO, CD69, CD127, and CD152.|Baseline, Days 20 and 90 post-transplantation|ITT Population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category, for respective arm groups.||percentage of lymphocytes||Standard Deviation|Mean
806514|NCT01014442|Secondary|Change From Baseline in Intracellular Adenosine-Tri-Phosphate (iATP) Levels|iATP was expressed in ng/mL.|Baseline, Days 4, 8, 20 and 90 post-transplantation|ITT Population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category, for respective arm groups.||ng/mL||Standard Deviation|Mean
806515|NCT01014442|Secondary|Forced Vital Capacity (FVC) at Day 90 Post-Transplantation|FVC at Day 90 post-transplantation is reported.|Day 90 post-transplantation|ITT Population. Here, Number of participants analyzed = participants evaluable for the outcome measure.||L||Standard Deviation|Mean
806516|NCT01014442|Secondary|Percent of Predicted FEV1 at Day 90 Post-Transplantation|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Percent predicted FEV1 [%] = (FEV1 [L] / Predicted normal value FEV1 [L]) * 100%|Day 90 post-transplantation|ITT Population. Here, Number of participants analyzed = participants evaluable for this outcome measure.||percentage of predicted FEV1||Standard Deviation|Mean
806517|NCT01014442|Secondary|Forced Expiratory Volume in 1 Second (FEV1) at Day 90 Post-Transplantation|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.|Day 90 post-transplantation|ITT Population (total 64 participants). Here, Number of participants analyzed = participants evaluable for this outcome measure.||L||Standard Deviation|Mean
806518|NCT01014442|Primary|Free Fraction of Free MPA at Day 90|MPA Free fraction (in %) was calculated by dividing free MPA AUC0-12 by total MPA AUC0-12 times 100%.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.||percentage of free fraction||Standard Deviation|Mean
806519|NCT01014442|Primary|Free Fraction of Free MPA at Day 20|MPA Free fraction (in %) was calculated by dividing free MPA AUC0-12 by total MPA AUC0-12 times 100%.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.||percentage of free fraction||Standard Deviation|Mean
806520|NCT01014442|Primary|Free Fraction of Free MPA at Day 8|MPA Free fraction (in %) was calculated by dividing free MPA AUC0-12 by total MPA AUC0-12 times 100%.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.||percentage of free fraction||Standard Deviation|Mean
806521|NCT01014442|Primary|Free Fraction of Free MPA at Day 4|MPA Free fraction (in percent [%]) was calculated by dividing free MPA AUC0-12 by total MPA AUC0-12 times 100%.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.||percentage of free fraction||Standard Deviation|Mean
806522|NCT01014442|Primary|Dose-Normalized AUC0-12 of MPA, MPAG, AcMPAG and Free MPA at Day 90|AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours. Dose-normalized AUC0-12 was determined (in hours/L) by dividing the AUC0-12 by the actual dose taken.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.||hours/L||Standard Deviation|Mean
806523|NCT01014442|Primary|Dose-Normalized AUC0-12 of MPA, MPAG, AcMPAG and Free MPA at Day 20|AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours. Dose-normalized AUC0-12 was determined (in hours/L) by dividing the AUC0-12 by the actual dose taken.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.||hours/L||Standard Deviation|Mean
806524|NCT01014442|Primary|Dose-Normalized AUC0-12 of MPA, MPAG, AcMPAG and Free MPA at Day 8|AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours. Dose-normalized AUC0-12 was determined (in hours/L) by dividing the AUC0-12 by the actual dose taken.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.||hours/L||Standard Deviation|Mean
806525|NCT01014442|Primary|Dose-Normalized AUC0-12 of MPA, MPAG, AcMPAG and Free MPA at Day 4|AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours. Dose-normalized AUC0-12 was determined (in hours/L) by dividing the AUC0-12 by the actual dose taken.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.||hours/L||Standard Deviation|Mean
806526|NCT01014442|Primary|AUC0-12 of Free MPA at Day 90|AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours*(mcg/L).|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.||hours*mcg/L||Standard Deviation|Mean
806527|NCT01014442|Primary|AUC0-12 of Free MPA at Day 20|AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours*(mcg/L).|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.||hours*mcg/L||Standard Deviation|Mean
806528|NCT01014442|Primary|AUC0-12 of Free MPA at Day 8|AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours*(mcg/L).|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.||hours*mcg/L||Standard Deviation|Mean
806529|NCT01014442|Primary|AUC0-12 of Free MPA at Day 4|AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours times micrograms per liter (hours*[mcg/L]).|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.||hours*mcg/L||Standard Deviation|Mean
806530|NCT01014442|Primary|AUC0-12 of MPA, MPAG and AcMPAG at Day 90|AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours*(mg/L).|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.||hours*(mg/L)||Standard Deviation|Mean
806531|NCT01014442|Primary|AUC0-12 of MPA, MPAG and AcMPAG at Day 20|AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours*(mg/L).|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.||hours*(mg/L)||Standard Deviation|Mean
806532|NCT01014442|Primary|AUC0-12 of MPA, MPAG and AcMPAG at Day 8|AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours*(mg/L).|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.||hours*(mg/L)||Standard Deviation|Mean
806533|NCT01014442|Primary|Area Under the Curve From Time 0 to 12 Hours (AUC0-12) of MPA, MPAG and AcMPAG at Day 4|AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours time milligrams per liter (hours*[mg/L]).|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.||hours*(mg/L)||Standard Deviation|Mean
806534|NCT01014442|Primary|CL of MPA, MPAG and AcMPAG at Day 90|CL is a quantitative measure of the rate at which a drug substance is removed from the body and expressed in L/hour.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.||L/hour||Standard Deviation|Mean
806535|NCT01014442|Primary|CL of MPA, MPAG and AcMPAG at Day 20|CL is a quantitative measure of the rate at which a drug substance is removed from the body and expressed in L/hour.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.||L/hour||Standard Deviation|Mean
806536|NCT01014442|Primary|CL of MPA, MPAG and AcMPAG at Day 8|CL is a quantitative measure of the rate at which a drug substance is removed from the body and expressed in L/hour.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.||L/hour||Standard Deviation|Mean
806537|NCT01014442|Primary|Clearance (CL) of MPA, MPAG and AcMPAG at Day 4|CL is a quantitative measure of the rate at which a drug substance is removed from the body and expressed in liters per hour (L/hour).|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.||L/hours||Standard Deviation|Mean
806538|NCT01014442|Primary|Vz of MPA, MPAG and AcMPAG at Day 90|Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.||Liter||Standard Deviation|Mean
806875|NCT01017237|Secondary|Respiratory Parameters: Oxyhemoglobin Saturation|Oxyhemoglobin saturation per pule oximeter|Immediately prior to surgery|per protocol||Percent oxyhemoglobin saturation||Standard Deviation|Mean
806539|NCT01014442|Primary|Vz of MPA, MPAG and AcMPAG at Day 20|Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.||Liter||Standard Deviation|Mean
806540|NCT01014442|Primary|Vz of MPA, MPAG and AcMPAG at Day 8|Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.||Liter||Standard Deviation|Mean
806541|NCT01014442|Primary|Volume of Distribution (Vz) of MPA, MPAG and AcMPAG at Day 4|Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.||Liter||Standard Deviation|Mean
806542|NCT01014442|Primary|Cmin of Free MPA at Day 90|Cmin was expressed in mcg/L.|Predose (0 hour) on Day 90 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.||mcg/L||Standard Deviation|Mean
806543|NCT01014442|Primary|Cmin of Free MPA at Day 20|Cmin was expressed in mcg/L.|Predose (0 hour) on Day 20 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.||mcg/L||Standard Deviation|Mean
806544|NCT01014442|Primary|Cmin of Free MPA at Day 8|Cmin was expressed in mcg/L.|Predose (0 hour) on Day 8 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.||mcg/L||Standard Deviation|Mean
806545|NCT01014442|Primary|Cmin of Free MPA at Day 4|Cmin was expressed in mcg/L.|Predose (0 hour) on Day 4 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.||mcg/L||Standard Deviation|Mean
806546|NCT01014442|Primary|Cmin of MPA, MPAG and AcMPAG at Day 90|Cmin was expressed in mg/L.|Predose (0 hour) on Day 90 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.||mg/L||Standard Deviation|Mean
806547|NCT01014442|Primary|Cmin of MPA, MPAG and AcMPAG at Day 20|Cmin was expressed in mg/L.|Predose (0 hour) on Day 20 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.||mg/L||Standard Deviation|Mean
806548|NCT01014442|Primary|Cmin of MPA, MPAG and AcMPAG at Day 8|Cmin was expressed in mg/L.|Predose (0 hour) on Day 8 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.||mg/L||Standard Deviation|Mean
806549|NCT01014442|Primary|Minimum Concentration (Cmin) of MPA, MPAG and AcMPAG at Day 4|Cmin was expressed in mg/L.|Predose (0 hour) on Day 4 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.||mg/L||Standard Deviation|Mean
806550|NCT01014442|Primary|Tmax of MPA, MPAG, AcMPAG and Free MPA at Day 90||Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.||hour||Standard Deviation|Mean
806551|NCT01014442|Primary|Tmax of MPA, MPAG, AcMPAG and Free MPA at Day 20||Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.||hour||Standard Deviation|Mean
806552|NCT01014442|Primary|Tmax of MPA, MPAG, AcMPAG and Free MPA at Day 8||Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.||hour||Standard Deviation|Mean
806553|NCT01014442|Primary|Time to Maximum Concentration (Tmax) of MPA, MPAG, AcMPAG and Free MPA at Day 4||Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.||hour||Standard Deviation|Mean
806554|NCT01014442|Primary|Dose-Normalized Cmax of MPA, MPAG, AcMPAG and Free MPA at Day 90|Dose-normalized Cmax was determined (in 1/L) by dividing the Cmax by the actual dose taken.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.||1/L||Standard Deviation|Mean
806555|NCT01014442|Primary|Dose-Normalized Cmax of MPA, MPAG, AcMPAG and Free MPA at Day 20|Dose-normalized Cmax was determined (in 1/L) by dividing the Cmax by the actual dose taken.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.||1/L||Standard Deviation|Mean
806876|NCT01017237|Secondary|Respiratory Parameters: Respiratory Rate|Rate of respirations|During surgical procedure|per protocol||Breaths per Minute||Standard Deviation|Mean
806556|NCT01014442|Primary|Dose-Normalized Cmax of MPA, MPAG, AcMPAG and Free MPA at Day 8|Dose-normalized Cmax was determined (in 1/L) by dividing the Cmax by the actual dose taken.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.||1/L||Standard Deviation|Mean
806557|NCT01014442|Primary|Dose-Normalized Cmax of MPA, MPAG, AcMPAG and Free MPA at Day 4|Dose-normalized Cmax was determined (in 1 per liter [1/L]) by dividing the Cmax by the actual dose taken.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.||1/L||Standard Deviation|Mean
806558|NCT01014442|Primary|Cmax of Free MPA at Day 90|Cmax was expressed in mcg/L.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.||mcg/L||Standard Deviation|Mean
806559|NCT01014442|Primary|Cmax of Free MPA at Day 20|Cmax was expressed in mcg/L.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.||mcg/L||Standard Deviation|Mean
806560|NCT01014442|Primary|Cmax of Free MPA at Day 8|Cmax was expressed in mcg/L.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.||mcg/L||Standard Deviation|Mean
806561|NCT01014442|Primary|Cmax of Free MPA at Day 4|Cmax was expressed in micrograms per liter (mcg/L).|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.||mcg/L||Standard Deviation|Mean
806562|NCT01014442|Primary|Cmax of MPA, MPAG and AcMPAG at Day 90|Cmax was expressed in mg/L.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.||mg/L||Standard Deviation|Mean
806563|NCT01014442|Primary|Cmax of MPA, MPAG and AcMPAG at Day 20|Cmax was expressed in mg/L.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.||mg/L||Standard Deviation|Mean
806564|NCT01014442|Primary|Cmax of MPA, MPAG and AcMPAG at Day 8|Cmax was expressed in mg/L.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.||mg/L||Standard Deviation|Mean
806565|NCT01014442|Primary|Maximum Concentration (Cmax) of Mycophenolic Acid (MPA), Mycophenolic Acid Glucuronide (MPAG) and Acyl Glucuronide Metabolite of Mycophenolic Acid (AcMPAG) at Day 4|Cmax was expressed in milligrams per liter (mg/L).|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 after transplantation|Per Protocol (PP) Population: Intent-to treat (ITT) population (received at least one dose of study drug and where the primary variable was measured at least once under study drug) excluding participants with major protocol violations (total 46 participants). Number of participants analyzed=participants who were evaluable for this outcome measure.||mg/L||Standard Deviation|Mean
806566|NCT01014455|Primary|Exhaled CO Level Measured Immediately Prior to Surgery|On the morning of surgery, as matter of clinical routine all patients receiving surgery requiring anesthesia services at one of the two main surgical facilities at Mayo Clinic Rochester and who self-report as a current smoker are asked about their typical cigarette consumption (cigarettes per day), if they have smoked cigarettes today, and have their exhaled CO levels measured (Micro Smokerlyzer; Bedfont, United Kingdom). This information is entered into the clinical record. The CO monitors are maintained by the Division of Respiratory Therapy, including regular calibration.|The median time from study assessment at POE to surgery was 1 day with an interquartile range of 1 to 3 days.|5 participants did not complete CO measures and were excluded from the analysis of primary outcome||ppm||Standard Deviation|Mean
806567|NCT01014455|Primary|Preoperative Carbon Monoxide Levels||the morning of surgery||||||
806568|NCT01014585|Secondary|Time to Worsening in Multidimensional Assessment of Fatigue (MAF)|Time to worsening in MAF is defined as the time from the first dose of double-blind investigational product to the first visit when a patient has a 10-point increase from baseline in the global index of fatigue in MAF. Scores range from 1 (no fatigue) to 50 (severe fatigue). The MAF contains 16 items measuring 4 dimensions of fatigue: severity, distress, degree of interference in activities of daily living, and timing. Fourteen of the items contain numerical rating scales (increasing in severity); the remaining 2 items have multiple-choice responses (decreasing in severity).|From baseline Visit 3 (week 5) to Visit 7 (week 17)|The Intent to Treat (ITT) Population for Responders is defined as all patients in the Safety Population for Responders with at least 1 post-baseline assessment of primary efficacy parameter. All patients in the Safety Population were included in the ITT population. No efficacy statistical analyses were performed for the Non-Responder population.||Days||95% Confidence Interval|Median
806569|NCT01014585|Secondary|Time to Worsening in Patient Global Impression of Change (PGIC)|"Time to worsening in Patient Global Impression of Change is defined as the time from the first dose of double-blind investigational product to the first visit when a patient has a PGIC score of 6 or 7. The PGIC is an efficacy assessment on a scale of 1-7 taken at visits 4, 5, 6 and 7. The wording of the assessment is as follows: Since the start of the study, overall my fibromyalgia is: 1=Very Much Improved, 2=Much Improved, 3=Minimally Improved, 4=No Change, 5=Minimally Worse, 6=Much Worse, and 7=Very Much Worse."|From baseline Visit 3 (week 5) to Visit 7 (week 17)|The Intent to Treat (ITT) Population for Responders is defined as all patients in the Safety Population for Responders with at least 1 post-baseline assessment of primary efficacy parameter. All patients in the Safety Population were included in the ITT population. No efficacy statistical analyses were performed for the Non-Responder population.||Days||95% Confidence Interval|Median
806756|NCT01016678|Primary|Number of Participants With 2-hour Pain Free Active Study Drug|All data was collected and measured from self-reported patient diaries|3 years|The number of subjects randomized to treatment was 104, which included 94 subjects who treated at least one migraine with study drug and were included in the safety and efficacy data analysis||Participants|||Number
806570|NCT01014585|Primary|Time to Loss of Therapeutic Response (LTR)|Time to loss of therapeutic response is defined as the time from the first dose of double-blind investigational product to the first visit when a patient has a < 30% reduction in Visual Analog Scale (VAS) pain score from pre-milnacipran exposure OR a worsening of fibromyalgia requiring, in the judgment of the investigator, an alternative treatment|From baseline Visit 3 (week 5) to Visit 7 (week 17)|The Intent to Treat (ITT) Population for Responders is defined as all patients in the Safety Population for Responders with at least 1 post-baseline assessment of primary efficacy parameter. All patients in the Safety Population were included in the ITT population. No efficacy statistical analyses were performed for the Non-Responder population.||Days||95% Confidence Interval|Median
806571|NCT01014624|Secondary|Time to Return to Baseline PRU for the Primary Population Using the Primary Definition of Return to Baseline in Relation to the Inhibition of Platelet Aggregation 24 Hours Following the Last Maintenance Dose.|Time to return to baseline PRU (<= 60 units of baseline) dependent upon baseline PRU and platelet % inhibition on Washout Period Day 1 but independent of treatment. The following regression model was derived for predicting number of days to R-to-B PRU where PI(1) represents platelet percentage inhibition on Washout Day 1. Number days to R-to-B PRU derived from: Number days to R-to-B PRU=-3.350+0.079*PI(1)+0.014*baseline PRU.|up to 12 days after the last dose|Subjects in the Primary Population. The Primary Population included subjects who entered the Washout Period and had platelet function testing data at both baseline (Visit 2) and Washout Period Day 1 (Visit 3). The primary definition of return to baseline was (Baseline PRU-PRU) less than or equal to 60 units.||days to return to baseline PRU|||Number
806572|NCT01014624|Secondary|Percentage of Platelet Inhibition on Washout Day 1|On the first day of the Washout Period (Visit 3), the blood draw for platelet function testing was obtained 24 hour (+/- 6 hours) after the last dose of study medication. Following Visit 3, platelet function testing was performed during each visit of the Washout Period until the subject met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/(Baseline PRU) less than or equal to 20%|Washout Day 1|Subjects in the Primary Population. The Primary Population included subjects who entered the Washout Period and had platelet function testing data at both baseline (Visit 2) and Washout Period Day 1 (Visit 3).||Percentage||Standard Deviation|Mean
806573|NCT01014624|Secondary|Day at Which 50%, 75%, and 90% of Subjects Returned to Baseline Platelet Function Based on the Secondary Definition of Return to Baseline Using the Responder Population.|On the first day of the Washout Period (Visit 3), the blood draw for platelet function testing was obtained 24 hour (+/- 6 hours) after the last dose of study medication. Following Visit 3, platelet function testing was performed during each visit of the Washout Period until the subject met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/(Baseline PRU) less than or equal to (<=) 20%|up to 12 days after the last dose|Subjects in Responder Pop. using secondary definition of R-to-B. Primary Pop. included subjects entered Washout Period and had platelet function data at both baseline and Washout Period Day 1. Responder Pop. was primary pop. excluding poor pharmacodynamic responders. Secondary definition of R-to-B was (Baseline PRU-PRU)/ (Baseline PRU) <= 20%||day50%, 75%, 90% returned to baseline|||Number
806574|NCT01014624|Secondary|Day at Which 50%, 75%, and 90% of Subjects Returned to Baseline Platelet Function Based on the Primary Definition of Return to Baseline Using the Responder Population.|On the first day of the Washout Period (Visit 3), the blood draw for platelet function testing was obtained 24 hours (+/-6 hours) after the last dose of study medication. Following Visit 3, platelet function testing ws performed during each visit of the Washout Period until the subject met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/Baseline PRU less than or equal to 20%.|up to 12 days after last dose|Subjects in Responder Pop. using primary definition of R-to-B. Primary Pop. included subjects entered Washout Period and had platelet function data at baseline and Washout Day 1. Responder Pop. was Primary Pop. excluding poor pharmacodynamic responders. Primary definition of R-to-B was (Baseline PRU-PRU) less than or equal to 60 units||day 50%, 75%, 90% returned to baseline|||Number
806575|NCT01014624|Secondary|Day at Which 50%, 75%, and 90% of Subjects Returned to Baseline Platelet Function Based on Secondary Definition of Return to Baseline Using the Primary Population.|On the first day of the Washout Period (Visit 3), the blood draw for platelet function testing was obtained 24 hours (+/-6 hours) after the last dose of study medication. Following Visit 3, platelet function testing ws performed during each visit of the Washout Period until the subject met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/Baseline PRU less than or equal to 20%.|up to 12 days after last dose|Subjects in Primary Population using secondary definition of return to baseline. Primary Population included subjects entered Washout Period and had platelet function data at both baseline and Washout Period Day 1. Secondary definition of return to baseline was (Baseline PRU-PRU)/Baseline PRU less than or equal to 20%||day 50%, 75%, 90% returned to baseline|||Number
806576|NCT01014624|Secondary|Day at Which 50%, 75%, and 90% of Subjects Returned to Baseline Platelet Function Based on Primary Definition of Return to Baseline Using the Primary Population.|On the first day of the Washout Period (Visit 3), the blood draw for platelet function testing was obtained 24 hours (+/-6 hours) after the last dose of study medication. Following Visit 3, platelet function testing ws performed during each visit of the Washout Period until the subject met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/Baseline PRU less than or equal to 20%.|up to 12 days after last dose|Subjects in Primary Population using primary definition of return to baseline. Primary population included subjects entered the Washout Period and had platelet function data at both baseline and Washout Period Day 1. Primary definition of return to baseline was (Baseline PRU-PRU) less than or equal to 60 units||day 50%, 75%, 90% returned to baseline|||Number
806613|NCT01006616|Secondary|Change From Baseline in Forced Expiratory Flow During the Middle Half of the Forced Vital Capacity (FEF25%–75%) Test|Mid-Breath Forced Expiratory Flow (FEF25%-75%), as measured in liters/minute by spirometry, is the rate at which participants breathe out air from 25 percent of their breath to 75 percent of their breath. FEF25%-75% was to be assessed at Baseline, Week 26, Week 52 and Week 104.|Baseline and Week 26, Week 52, Week 104|The FAS population consisted of all participants who received at least one dose of study drug and had a Baseline and Week 26, Week 52 or Week 104 assessment for FEF25%-75%. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.||Liters/minute||Standard Error|Least Squares Mean
806757|NCT01016691|Secondary|Mean Change in Intraocular Pressure at Day 5||Day 4 to Day 5||||||
806577|NCT01014624|Primary|The Time to Return to Baseline Platelet Function as Assessed by P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNOW P2Y12 Device Based on the Secondary Definition of Return to Baseline.|On the first day of the Washout Period (visit 3), the blood draw for platelet function testing was obtained 24 hours (+/- 6 hours) after the last dose of study medication. Following Visit 3, platelet function testing was performed during each visit of the Washout Period until the subject met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/(Baseline PRU) less than or equal to 20%|up to 12 days after last dose|Subjects in Primary Pop. using secondary definition of return to baseline. Primary Population included subjects entered the Washout Period and had platelet function data at both baseline and Washout Period Day 1. Secondary definition of return to baseline was (Baseline PRU-PRU)/Baseline PRU less than or equal to 20%||cumulative percent returned to baseline|||Number
806578|NCT01014624|Primary|The Time to Return to Baseline Platelet Function as Assessed by P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNOW P2Y12 Device Based on the Primary Definition of Return to Baseline|On the first day of the Washout Period (Visit 3), the blood draw for platelet function testing was obtained 24 hours (+/- 6 hours) after the last dose of study medication. Following Visit 3, platelet function testing was performed during each visit of the Washout Period until the subject met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/(Baseline PRU) less than or equal to 20%. The results are expressed as cumulative percentage of subjects.|up to 12 days after last dose|Subjects in Primary Population (Pop.) using primary definition of R-to-B. Primary Pop. included subjects entered Washout Period and had platelet function data at both baseline and Washout Period Day 1. Primary definition of R-to-B was (Baseline PRU-PRU) less than or equal to 60 units.||cumulative percentage of subjects|||Number
806579|NCT01006590|Secondary|Change From Baseline to Week 24 in Beta-cell Function as Measured by Homeostasis Model Assessment-2-beta||Baseline and 24 weeks|||Percent (%)||Standard Error|Mean
806580|NCT01006590|Secondary|Change From Baseline to Week 24 in Fasting Insulin||Baseline and 24 weeks|||microUnit/milliLiter||Standard Error|Mean
806581|NCT01006590|Secondary|Change From Baseline to Week 24 in Fasting Plasma Glucose||Baseline and 24 weeks|||millimol/Liter||Standard Error|Mean
806582|NCT01006590|Secondary|Proportion of Patients Achieving a Therapeutic Response at Week 24 Defined as HbA1c<=6.5%|Proportion, percentage of patients in each treatment group, achieving therapeutic response, HbA1c below or equal to 6.5 percent|24 Weeks|||Percentage of patients|||Number
806583|NCT01006590|Secondary|Proportion of Patients Achieving a Therapeutic Response at Week 24 Defined as HbA1c<7.0%|Proportion, percentage of patients in each treatment group, achieving therapeutic response, HbA1c below 7.0 percent|24 Weeks|||Percentage of patients|||Number
806584|NCT01006590|Primary|Absolute Change From Baseline in HbA1c at Week 24||Baseline and 24 weeks|||Percent (%)||Standard Error|Mean
806585|NCT01006603|Secondary|Change From Baseline to Week 52 in β-cell Function (as Measured by Homeostasis Model Assessment-β [HOMA-β]|β-cell function as estimated by the homeostasis model assessment (HOMA) model. Value is derived from FPG and fasting insulin; fasting insulin values below 2.074 μU/mL or above 57.595 μU/mL and FPG values below 3 mmol/L or above 25 mmol/L are excluded (as restricted by the calculation method used). Full analysis set.|From week 0 to week 52|The number of subjects with non-missing baseline and Week 52 (LOCF) values in the full analysis set (defined as the subset of patients in the randomized analysis set who took at least one randomised IP dose and have non-missing baseline and post-baseline efficacy data for at least one variable).||percentage of change from baseline||95% Confidence Interval|Mean
806586|NCT01006603|Secondary|Change From Baseline to Week 52 in Insulin|Measured as the difference between the last on-treatment value (defined as obtained before or on the first day after the last dosing date) and the last pre-randomisation fasting plasma insulin value, as determined by central laboratory. Full analysis set.|From week 0 to week 52|The number of subjects with non-missing baseline and Week 52 (LOCF) values in the full analysis set (defined as the subset of patients in the randomized analysis set who took at least one randomised IP dose and have non-missing baseline and post-baseline efficacy data for at least one variable).||µU/mL||95% Confidence Interval|Mean
806587|NCT01006603|Secondary|Change From Baseline to Week 52 in Fasting Plasma Glucose (FPG)|Measured as the difference between the last on-treatment value (defined as obtained before or on the first day after the last dosing date)and the last pre-randomisation fasting plasma glucose value, as determined by central laboratory. Full analysis set.|From week 0 to week 52|The number of subjects with non-missing baseline and Week 52 (LOCF) values in the full analysis set (defined as the subset of patients in the randomized analysis set who took at least one randomised IP dose and have non-missing baseline and post-baseline efficacy data for at least one variable).||mmol/L||95% Confidence Interval|Mean
806588|NCT01006603|Secondary|Proportion of Patients Achieving a Therapeutic Glycaemic Response at Week 52 Defined as HbA1c <7.0%|Proportion of patients with their last on-treatment value (defined as obtained before or on the 8th day after the last dosing date), as determined by central laboratory, below the specified limits. Full analysis set.|From week 0 to week 52|The number of subjects with non-missing baseline and Week 52 (LOCF) values in the full analysis set (defined as the subset of patients in the randomized analysis set who took at least one randomised IP dose and have non-missing baseline and post-baseline efficacy data for at least one variable).||percentage of responders|||Number
806589|NCT01006603|Secondary|Change From Baseline to Week 52 in HbA1c.|Measured as the difference between the last on-treatment value (defined as obtained before or on the 8th day after the last dosing date), and the last pre-randomisation HbA1c value, as determined by central laboratory. Full analysis set.|From week 0 to week 52.|The number of subjects with non-missing baseline and Week 52 (LOCF) values in the full analysis set (defined as the subset of patients in the randomized analysis set who took at least one randomised IP dose and have non-missing baseline and post-baseline efficacy data for at least one variable).||% of glycosylated hemoglobin||95% Confidence Interval|Mean
806614|NCT01006616|Secondary|Change From Baseline in Pre-bronchodilator FEV1|FEV1, as measured in liters by spirometry, is the amount of air expired in 1 second. Pre-bronchodilator FEV1 was to be assessed immediately before bronchodilator administration at Baseline, Week 26, Week 52 and Week 104.|Baseline and Week 26, Week 52, Week 104|The FAS population consisted of all participants who received at least one dose of study drug and had a Baseline and Week 26, Week 52 or Week 104 assessment for pre-bronchodilator FEV1. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.||Liters||Standard Error|Least Squares Mean
806590|NCT01006603|Secondary|Proportion of Patients Having Experienced at Least One Hypoglycaemic Event (Confirmed or Severe) Over the 52-week Double-blind Treatment Period.|"Hypoglyceamic event defined as, Confirmed hypoglycaemia: any event defined as either a symptomatic event with blood glucose level <3 mmol/L (<54 mg/dL) and no need for external assistance, or an asymptomatic blood glucose measurement <3 mmol/L (<54 mg/dL).
Major (or severe) hypoglycaemia: symptomatic events requiring external assistance due to severe impairment in consciousness or behaviour, with or without blood glucose level <3 mmol/L (<54 mg/dL), but with prompt recovery after glucose or glucagon administration. These events may be associated with sufficient neuroglycopenia to induce seizure or coma. Plasma glucose measurements may not be available during such an event, but neurological recovery, attributable to the restoration of plasma glucose to normal, was considered sufficient evidence that the event was induced by a low plasma glucose concentration. Safety analysis set."|From week 0 to week 52.|Safety analysis set (a subset of the randomised analysis set including patients who took at least one investigational product dose).||percentage of patients|||Number
806591|NCT01006603|Primary|Proportion of Patients Reaching HbA1c <7% After 52 Weeks of Treatment Without Confirmed or Severe Hypoglycaemia.|"Defined as obtained on or before the 8th day after the last dosing day, as determined by central laboratory. Safety analysis set.
Confirmed hypoglycaemia defined as: any event defined as either a symptomatic event with blood glucose level <3 mmol/L (<54 mg/dL) and no need for external assistance, or an asymptomatic blood glucose measurement <3 mmol/L (<54 mg/dL).
Major (or severe) hypoglycaemia defined as: symptomatic events requiring external assistance due to severe impairment in consciousness or behaviour, with or without blood glucose level <3 mmol/L (<54 mg/dL), but with prompt recovery after glucose or glucagon administration. These events may be associated with sufficient neuroglycopenia to induce seizure or coma. Plasma glucose measurements may not be available during such an event, but neurological recovery, attributable to the restoration of plasma glucose to normal, was considered sufficient evidence that the event was induced by a low plasma glucose concentration."|From week 0 to week 52.|Safety analysis set (a subset of the randomised analysis set including patients who took at least one investigational product dose).||percentage of participants|||Number
806592|NCT01006616|Secondary|Percentage of Participants Who Experienced an AE Related to Any Type of Infection|The percentage of participants who experienced an AE related to any type of infection or infestation, was to be calculated for the first 26 weeks, the first 52 weeks and the first 104 weeks of treatment.|Up to 26 , 52 and 104 weeks|The ASaT population consisted of all participants who received at least one dose of study drug. The study was terminated during Period 2; no data were analyzed for this endpoint for up to 104 weeks.||Percentage of Participants|||Number
806593|NCT01006616|Secondary|Percentage of Participants Who Experienced an AE Related to Respiratory Infection|The percentage of participants who experienced an AE related to a respiratory infection or infestation, was to be calculated for the first 26 weeks, the first 52 weeks and the first 104 weeks of treatment.|Up to 26 , 52 and 104 weeks|The ASaT population consisted of all participants who received at least one dose of study drug. The study was terminated during Period 2; no data were analyzed for this endpoint for up to 104 weeks.||Percentage of Participants|||Number
806594|NCT01006616|Secondary|Change From Baseline in Percent of Arterial Oxygen Saturation Measured by Pulse Oximetry Before and After the 6-Minute Walk Test|The 6-minute walk test measured the distance participants could walk quickly on a flat, hard surface in 6 minutes. Percent (%) of arterial oxygen saturation, as measured by pulse oximetry, was to be assessed before and after the 6-minute walk test at Baseline, Week 26, Week 52 and Week 104.|Baseline and Week 26, Week 52, Week 104|The FAS population consisted of all participants at selected sites who received at least one dose of study drug and had a Baseline and Week 26, Week 52 or Week 104 assessment for pre- and post-6-minute-walk-test arterial oxygen saturation. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.||Percent Oxygen Saturation||Standard Error|Least Squares Mean
806595|NCT01006616|Secondary|Change From Baseline in Pre- and Post-6-Minute-Walk-Test Borg Scale Score|The 6-minute walk test measured the distance participants could walk quickly on a flat, hard surface in 6 minutes. The Borg scale is a method use to rate perceived exertion (0=Nothing at all [no exertion] to 10=Maximal [exertion]). Borg scale scores were to be assessed pre- and post-walk-test at Baseline, Week 26, Week 52 and Week 104. A higher score indicates greater perceived exertion.|Baseline and Week 26, Week 52, Week 104|The FAS population consisted of all participants at selected sites who received at least one dose of study drug and had a Baseline and Week 26, Week 52 or Week 104 assessment for pre- and post-6-minute-walk-test Borg scale score. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.||Score on a Scale||Standard Error|Least Squares Mean
806596|NCT01006616|Secondary|Plasma Inflammatory Biomarker Levels: Epithelial Cell-Derived Neutrophil Activating Peptide 78 (ENA-78)|Blood samples were to be collected prior to study drug administration to determine participant plasma ENA-78 levels at Week 26, Week 52 and Week 104. The reported Baseline LS means and SDs are pooled across all treatment groups. The rationale for the use of pooled Baseline LS mean and SD values is the assumption that the Baseline LS mean and SD values are similar across treatment groups. The reported post-Baseline SDs are pooled across all treatment groups. The rationale for the use of an ANOVA method using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline, Week 26, Week 52, Week 104|The FAS population consisted of all participants who received at least one dose of study drug and had a Week 26, Week 52 or Week 104 assessment for ENA-78 level. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.||pg/mL||Standard Deviation|Least Squares Mean
806597|NCT01006616|Secondary|Plasma Inflammatory Biomarker Levels: Plasma Neutrophil Elastase|Blood samples were to be collected prior to study drug administration to determine participant plasma neutrophil elastase levels at Week 26, Week 52 and Week 104. The reported Baseline LS means and SDs are pooled across all treatment groups. The rationale for the use of pooled Baseline LS mean and SD values is the assumption that the Baseline LS mean and SD values are similar across treatment groups. The reported post-Baseline SDs are pooled across all treatment groups. The rationale for the use of an ANOVA method using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline, Week 26, Week 52, Week 104|The FAS population consisted of all participants who received at least one dose of study drug and had a Week 26, Week 52 or Week 104 assessment for plasma neutrophil elastase level. The study was terminated during Period 2; no data were collected for the endpoint at Week 104.||ng/mL||Standard Deviation|Least Squares Mean
806758|NCT01016691|Secondary|Mean Change in Intraocular Pressure at Day 4||Baseline to Day 4||||||
806598|NCT01006616|Secondary|Plasma Inflammatory Biomarker Levels: Matrix Metallopeptidase-9 (MMP-9)|Blood samples were to be collected prior to study drug administration to determine participant plasma MMP-9 levels at Week 26, Week 52 and Week 104. The reported Baseline LS means and SDs are pooled across all treatment groups. The rationale for the use of pooled Baseline LS mean and SD values is the assumption that the Baseline LS mean and SD values are similar across treatment groups. The reported post-Baseline SDs are pooled across all treatment groups. The rationale for the use of an ANOVA method using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline, Week 26, Week 52, Week 104|The FAS population consisted of all participants who received at least one dose of study drug and had a Week 26, Week 52 or Week 104 assessment for MMP-9 level. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.||ng/mL||Standard Deviation|Least Squares Mean
806599|NCT01006616|Secondary|Plasma Inflammatory Biomarker Levels: Myeloperoxidase (MPO)|Blood samples were to be collected prior to study drug administration to determine participant plasma MPO levels at Week 26, Week 52 and Week 104. The reported Baseline LS means and SDs are pooled across all treatment groups. The rationale for the use of pooled Baseline LS mean and SD values is the assumption that the Baseline LS mean and SD values are similar across treatment groups. The reported post-Baseline SDs are pooled across all treatment groups. The rationale for the use of an ANOVA method using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline, Week 26, Week 52, Week 104|The FAS population consisted of all participants who received at least one dose of study drug and had a Week 26, Week 52 or Week 104 assessment for MPO level. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.||ng/mL||Standard Deviation|Least Squares Mean
806600|NCT01006616|Secondary|Plasma Inflammatory Biomarker Levels: Fibrinogen|Blood samples were to be collected prior to study drug administration to determine participant plasma fibrinogen levels at Week 26, Week 52 and Week 104. The reported Baseline LS means and SDs are pooled across all treatment groups. The rationale for the use of pooled Baseline LS mean and SD values is the assumption that the Baseline LS mean and SD values are similar across treatment groups. The reported post-Baseline SDs are pooled across all treatment groups. The rationale for the use of an ANOVA method using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline, Week 26, Week 52, Week 104|The FAS population consisted of all participants who received at least one dose of study drug and had a Week 26, Week 52 or Week 104 assessment for plasma fibrinogen level. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.||mg/dL||Standard Deviation|Least Squares Mean
806601|NCT01006616|Secondary|Plasma Inflammatory Biomarker Levels: High-sensitivity C-reactive Protein (Hs-CRP)|Blood samples were to be collected prior to study drug administration to determine participant plasma hs-CRP levels at Week 26, Week 52 and Week 104. The reported Baseline LS means and SDs are pooled across all treatment groups. The rationale for the use of pooled Baseline LS mean and SD values is the assumption that the Baseline LS mean and SD values are similar across treatment groups. The reported post-Baseline SDs are pooled across all treatment groups. The rationale for the use of an ANOVA method using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline, Week 26, Week 52, Week 104|The FAS population consisted of all participants who received at least one dose of study drug and had a Week 26, Week 52 or Week 104 assessment for plasma hs-CRP level. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.||mg/dL||Standard Deviation|Least Squares Mean
806602|NCT01006616|Secondary|Sputum Inflammatory Marker Levels: Matrix Metallopeptidase-9 (MMP-9)|Induced sputum samples were to be collected from participants via the nebulized method prior to study drug administration at Week 26, Week 52 and Week 104. MMP-9 levels were measured by ELISA in the sputum supernatant. The reported Baseline LS means and SDs are pooled across all treatment groups. The rationale for the use of pooled Baseline LS mean and SD values is the assumption that the Baseline LS mean and SD values are similar across treatment groups. The reported post-Baseline SDs are pooled across all treatment groups. The rationale for the use of an ANOVA method using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline, Week 26, Week 52, Week 104|The FAS population consisted of all participants at selected sites who received at least one dose of study drug and had a Week 26, Week 52 or Week 104 assessment for induced sputum MMP-9 level. The study was terminated during Period 2; no data were collected for this endpoint at Weeks 52 or 104.||ng/mL||Standard Deviation|Least Squares Mean
806603|NCT01006616|Secondary|Sputum Inflammatory Marker Levels: Sputum Neutrophil Elastase|Induced sputum samples were to be collected from participants via the nebulized method prior to study drug administration at Week 26, Week 52 and Week 104. Neutrophil elastase levels were measured in the sputum supernatant. The reported Baseline LS means and SDs are pooled across all treatment groups. The rationale for the use of pooled Baseline LS mean and SD values is the assumption that the Baseline LS mean and SD values are similar across treatment groups. The reported post-Baseline SDs are pooled across all treatment groups. The rationale for the use of an ANOVA method using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline, Week 26, Week 52, Week 104|The FAS population consisted of all participants at selected sites who received at least one dose of study drug and had a Week 26, Week 52 or Week 104 assessment for sputum neutrophil elastase level. The study was terminated during Period 2; no data were collected for this endpoint at Weeks 52 or 104.||ng/mL||Standard Deviation|Least Squares Mean
806604|NCT01006616|Secondary|Sputum Inflammatory Marker Levels: Myeloperoxidase (MPO)|Induced sputum samples were to be collected from participants via the nebulized method prior to study drug administration at Week 26, Week 52 and Week 104. MPO levels were measured by ELISA in the sputum supernatant. The reported Baseline LS means and SDs are pooled across all treatment groups. The rationale for the use of pooled Baseline LS mean and SD values is the assumption that the Baseline LS mean and SD values are similar across treatment groups. The reported post-Baseline SDs are pooled across all treatment groups. The rationale for the use of an ANOVA method using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline, Week 26, Week 52, Week 104|The FAS population consisted of all participants at selected sites who received at least one dose of study drug and had a Week 26, Week 52 or Week 104 assessment for sputum MPO level. The study was terminated during Period 2; no data were collected for this endpoint at Weeks 52 or 104.||ng/mL||Standard Deviation|Least Squares Mean
806759|NCT01016691|Secondary|Mean Change in Intraocular Pressure at Day 3||Baseline to Day 3||||||
806760|NCT01016691|Secondary|Mean Change in Intraocular Pressure at Day 2||Baseline to Day 2||||||
806605|NCT01006616|Secondary|Sputum Inflammatory Marker Levels: Interleukin 8 (IL-8)|Induced sputum samples were to be collected from participants via the nebulized method prior to study drug administration at Week 26, Week 52 and Week 104. IL-8 levels were measured by enzyme-linked immunosorbent assay (ELISA) in the sputum supernatant. The reported Baseline LS means and SDs are pooled across all treatment groups. The rationale for the use of pooled Baseline LS mean and SD values is the assumption that the Baseline LS mean and SD values are similar across treatment groups. The reported post-Baseline SDs are pooled across all treatment groups. The rationale for the use of an ANOVA method using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline, Week 26, Week 52, Week 104|The FAS population consisted of all participants at selected sites who received at least one dose of study drug and had a Week 26, Week 52 or Week 104 assessment for sputum IL-8 level. The study was terminated during Period 2; no data were collected for this endpoint at Weeks 52 or 104.||pg/mL||Standard Deviation|Least Squares Mean
806606|NCT01006616|Secondary|Change From Baseline in Modified Medical Research Council (MMRC) Dyspnea Score|The MMRC dyspnea scale is used to assess participant breathlessness. The MMRC dyspnea scale consists of five grades that describe almost the entire range of respiratory disability from none (Grade 0=Not troubled with breathlessness except with strenuous exercise) to almost complete incapacity (Grade 4=Too breathless to leave the house or breathless when dressing or undressing). MMRC dyspnea scores were to be assessed at Baseline, Week 26, Week 52 and Week 104.|Baseline and Week 26, Week 52, Week 104|The FAS population consisted of all participants who received at least one dose of study drug and had a Baseline and Week 26, Week 52 or Week 104 assessment for MMRC dyspnea score. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.||Score on a Scale||Standard Error|Least Squares Mean
806607|NCT01006616|Secondary|Change From Baseline in Body-Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity (BODE) Index Score|The BODE index is a composite score assessing COPD prognosis that consists of 4 variables that are individually scored: FEV1 percent predicted, 6-Minute Walk Test, Modified Medical Research Council (MMRC) dyspnea scale and body mass index (BMI). The FEV1 percent predicted was scored from ≥65% (0 points, less airway obstruction) to ≤35% (3 points, greater airway obstruction). The 6-Minute Walk Distance was scored from: ≥350 meters (0 points, good exercise capacity) to ≤149 meters (3 points, poor exercise capacity). The MMRC Dyspnea Scale was scored from: MMRC 0: Dyspneic on strenuous exercise (0 points) to MMRC 4: Cannot leave house; breathless on dressing/undressing (3 points). BMI was scored as: >21 (0 points) and ≤21 (1 point). Variable scores were summed to produce a BODE index score. BODE index scores could range from 0 to 10, with a higher score correlating with an increased risk of COPD mortality. BODE index scores were to be assessed at Baseline, Week 26, Week 52 and Week 104.|Baseline and Week 26, Week 52, Week 104|The FAS population consisted of all participants at selected sites who received at least one dose of study drug and had a Baseline and Week 26, Week 52 or Week 104 assessment for BODE index score. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.||Score on a Scale||Standard Error|Least Squares Mean
806608|NCT01006616|Secondary|Change From Baseline in Morning Peak Expiratory Flow (PEF)|PEF, as measured in liters/minute with a peak flow meter, is the maximum speed of expiration. Participants were to perform at least 3 and up to 5 PEF measurements in the morning before taking study drug. PEF was to be assessed at Baseline, Week 26, Week 52 and Week 104.|Baseline and Week 26, Week 52, Week 104|The FAS population consisted of all participants who received at least one dose of study drug and had a Baseline and Week 26, Week 52 or Week 104 assessment for PEF. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.||Liters/minute||Standard Error|Least Squares Mean
806609|NCT01006616|Secondary|Change From Baseline in Inspiratory Capacity (IC)|IC, as measured in liters by body plethysmography, is the maximum amount of air inspired when taking a slow, full inspiration with no hesitation from a position of passive end-tidal expiration (i.e. FRC) to a position of maximal inspiration. IC was to be assessed after post-bronchodilator spirometry tests were performed at Baseline, Week 26, Week 52 and Week 104.|Baseline and Week 26, Week 52, Week 104|The FAS population consisted of all participants who received at least one dose of study drug and had a Baseline and Week 26, Week 52 or Week 104 assessment for IC. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.||Liters||Standard Error|Least Squares Mean
806610|NCT01006616|Secondary|Change From Baseline in Total Lung Capacity (TLC)|TLC, as measured in liters by body plethysmography, is the most amount of air lungs can hold at the top of breathing in. TLC was to be assessed after post-bronchodilator spirometry tests were performed at Baseline, Week 26, Week 52 and Week 104.|Baseline and Week 26, Week 52, Week 104|The FAS population consisted of all participants who received at least one dose of study drug and had a Baseline and Week 26, Week 52 or Week 104 assessment for TLC. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.||Liters||Standard Error|Least Squares Mean
806611|NCT01006616|Secondary|Change From Baseline in Functional Residual Capacity (FRC)|FRC, as measured in liters by body plethysmography, is the volume of air present in the lungs at the end of passive expiration. FRC was to be assessed after post-bronchodilator spirometry tests were performed at Baseline, Week 26, Week 52 and Week 104.|Baseline and Week 26, Week 52, Week 104|The FAS population consisted of all participants who received at least one dose of study drug and had a Baseline and Week 26, Week 52 or Week 104 assessment for FRC. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.||Liters||Standard Error|Least Squares Mean
806612|NCT01006616|Secondary|Change From Baseline in Post-bronchodilator Forced Vital Capacity (FVC)|FVC, as measured in liters by spirometry, is the amount of air forcibly exhaled from the lungs after taking the deepest breath possible. Post-bronchodilator FVC was to be assessed 30 minutes after bronchodilator administration (4 puffs of albuterol/salbutamol or equivalent separated by 30-second intervals) at Baseline, Week 26, Week 52 and Week 104.|Baseline and Week 26, Week 52, Week 104|The FAS population consisted of all participants who received at least one dose of study drug and had a Baseline and Week 26, Week 52 or Week 104 assessment for post-bronchodilator FVC. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.||Liters||Standard Error|Least Squares Mean
806700|NCT01014936|Primary|Number of Subjects With Treatment-Related Adverse Events|Related AE was defined as any untoward medical occurrence which was considered to have a relationship with the study drug (suspected to be reasonably related to the study drug or AE was medically (pharmacologically/clinically) attributed to the study drug as per Investigator’s assessment.|Baseline up to 158.01 weeks|Safety set included all subjects who had received at least 1 dose of MSC2156119J treatment.||subjects|||Number
806615|NCT01006616|Secondary|Change From Baseline in Distance Walked in 6 Minutes (6-Minute Walk Test)|The 6-minute walk test measures the distance participants can walk quickly on a flat, hard surface in 6 minutes. The 6-minute walk test was to be conducted at Baseline, Week 26, Week 52 and Week 104.|Baseline and Week 26, Week 52, Week 104|The FAS population consisted of all participants at selected sites who received at least one dose of study drug and had a Baseline and Week 26, Week 52 or Week 104 assessment for 6-minute walk test. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.||Meters||Standard Error|Least Squares Mean
806616|NCT01006616|Secondary|Change From Baseline in St. George’s Respiratory Questionnaire for COPD Patients (SGRQ-C) Total Score|The SGRQ-C consists of 40 items aggregated into 3 component scores: Symptoms (frequency/severity), Activity (limited by breathlessness), Impacts (social functioning, psychological disturbances), and a Total score. Each response to a question is assigned a weight. Component scores are calculated by summing the weights from all positive items in that component, dividing by the sum of weights for all items in that component, and multiplying this number by 100. Component scores could range from 0-100, with a higher component score indicating greater disease burden. The Total score is calculated by summing the weights to all the positive responses in each component, dividing by the sum of weights for all items in the questionnaire, and multiplying this number by 100. SGRQ-C Total scores could range from 0-100, with a higher SGRQ-C Total score indicating greater disease burden. Participants were to assess their COPD symptoms, activity and impact at Baseline, Week 26, Week 52, and Week 104.|Baseline and Week 26, Week 52, Week 104|The FAS population consisted of all participants who received at least one dose of study drug and had a Baseline and Week 26, Week 52 or Week 104 assessment for SGRQ-C score. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.||Score on a Scale||Standard Error|Least Squares Mean
806617|NCT01006616|Secondary|Induced Sputum Absolute Neutrophil Counts|Induced sputum samples were to be obtained from participants via the nebulized method for analysis of absolute neutrophil counts at Week 26, Week 52 and Week 104. The reported Baseline least squares (LS) means and standard deviations (SDs) are pooled across all treatment groups. The rationale for the use of pooled Baseline LS mean and SD values is the assumption that the Baseline LS mean and SD values are similar across treatment groups. The reported post-Baseline SDs are pooled across all treatment groups. The rationale for the use of an analysis of variance (ANOVA) method using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline, Week 26, Week 52, Week 104|The FAS population consisted of all participants at selected sites who received at least one dose of study drug and had a baseline and Week 26, Week 52 or Week 104 assessment for sputum neutrophil count. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.||10^9 cells/L||Standard Deviation|Least Squares Mean
806618|NCT01006616|Secondary|Total Exacerbations of Chronic Pulmonary Disease Tool-Patient-Recorded Outcome (EXACT-PRO) Questionnaire Score|The total score on the EXACT-PRO questionnaire is used to determine the frequency, severity, and duration of exacerbations of COPD. The 14-item EXACT-PRO questionnaire was to be completed by participants every evening to describe their experience of COPD during that day. Assessments were included for Breathlessness (5 items), Cough and Sputum (2 items), Chest Symptoms (3 items), and 4 additional items (Difficulty with Sputum, Tired or Weak, Sleep Disturbance, and Psychological State). Each item was measured on a 5- or 6-point scale. The total EXACT-PRO questionnaire score could range from 0 to 100, with a higher score indicating a more severe health state.|At 26, 52 and 104 weeks|The FAS population was to consist of all participants who received at least one dose of study drug and had a Baseline and Week 26, Week 52 or Week 104 assessment for total EXACT-PRO score. This analysis was not conducted if results for percentage of participants with moderate to severe COPD exacerbation suggested no need for further investigation.|||||
806619|NCT01006616|Secondary|Percentage of Participants With a Moderate to Severe COPD Exacerbation|COPD exacerbation is defined as any deterioration of symptoms that leads to an increase in bronchodilator use on 2 or more consecutive days, or administration (at investigator's discretion) of antibiotics and/or systemic corticosteroids (above participant's usual dose), or an unscheduled COPD-related doctor visit, hospitalization or emergency room treatment. The percentages of participants who experienced at least one moderate to severe COPD exacerbation during the first 26 weeks, the first 52 weeks and the first 104 weeks of treatment were to be summarized.|Up to 26, 52 and 104 weeks|The FAS population consisted of all participants who received at least one dose of study drug and had a Baseline and Week 26, Week 52 or Week 104 assessment for COPD exacerbation. The study was terminated during Period 2; no data were collected for this endpoint for up to 104 weeks.||Percentage of Participants|||Number
806620|NCT01006616|Secondary|Number of Participants With a Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation|COPD exacerbation is defined as any deterioration of symptoms that leads to an increase in bronchodilator use on 2 or more consecutive days, or administration (at investigator's discretion) of antibiotics and/or systemic corticosteroids (above participant's usual dose), or an unscheduled COPD-related doctor visit, hospitalization or emergency room treatment. The numbers of participants who experienced at least one moderate to severe COPD exacerbation during the first 26 weeks, the first 52 weeks and the first 104 weeks of treatment were to be summarized.|Up to 26 , 52 and 104 weeks|The FAS population consisted of all participants who received at least one dose of study drug and had a Week 26, Week 52 or Week 104 assessment for COPD exacerbation. The study was terminated during Period 2; no data were collected for this endpoint for up to 104 weeks.||Participants|||Number
806621|NCT01006616|Secondary|Change From Baseline in Post-bronchodilator FEV1 (Period 2)|FEV1, as measured in liters by spirometry, is the amount of air expired in 1 second. Participants were to be assessed for post-bronchodilator FEV1 30 minutes after bronchodilator administration (4 puffs of albuterol/salbutamol or equivalent separated by 30-second intervals) (reversibility test) at Baseline, Week 52 and Week 104.|Baseline and Week 52, Week 104|The FAS population consisted of all participants who received at least one dose of study drug and had a Baseline and Week 52 or Week 104 assessment for post-bronchodilator FEV1 in Period 2. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.||Liters||Standard Error|Least Squares Mean
806653|NCT01014936|Secondary|Apparent Terminal Rate Constant (λz) After Multiple Dose of MSC2156119J: Regimen 1|Apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant.|||||
806622|NCT01006616|Primary|Percentage of Participants With an Adverse Event (AE) Related to a Blood Absolute Neutrophil Count (ANC) of Less Than 1.5x10^9 Cells/L|The percentage of participants who experienced an AE related to an ANC of less than 1.5x10^9 cells/L at one or more visits during the first 26 weeks, the first 52 weeks and the first 104 weeks was to be calculated.|Up to 104 weeks|The All Subjects as Treated (ASaT) population consisted of all participants who received at least one dose of study drug. The study was terminated during Period 2; no data were analyzed for this endpoint for up to 52 and up to 104 weeks.||Percentage of Participants|||Number
806623|NCT01006616|Primary|Change From Baseline in Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) (Period 1)|FEV1, as measured in liters by spirometry, is the amount of air expired in 1 second. Participants were assessed for post-bronchodilator FEV1 30 minutes after bronchodilator administration (4 puffs of albuterol/salbutamol or equivalent separated by 30-second intervals) (reversibility test) at Baseline and Week 26.|Baseline and Week 26|The Full Analysis Set (FAS) population consisted of all participants who received at least one dose of study drug and had a Baseline and Week 26 assessment for post-bronchodilator FEV1.||Liters||Standard Error|Least Squares Mean
806624|NCT01006629|Secondary|Total Days of Mechanical Ventilation During RSV Hospitalization|All secondary outcome measures were related to hospitalization due to RSV infection. No RSV hospitalizations occurred during the study; therefore, evaluation of the secondary outcome measures was not possible.|Through 30 days following the last injection of palivizumab|||days||Standard Deviation|Mean
806625|NCT01006629|Secondary|Number of Subjects Who Received Mechanical Ventilation During RSV Hospitalization|All secondary outcome measures were related to hospitalization due to RSV infection. No RSV hospitalizations occurred during the study; therefore, evaluation of the secondary outcome measures was not possible.|Through 30 days following the last injection of palivizumab|||participants|||Number
806626|NCT01006629|Secondary|Total Days of RSV ICU Stay|All secondary outcome measures were related to hospitalization due to RSV infection. No RSV hospitalizations occurred during the study; therefore, evaluation of the secondary outcome measures was not possible.|Through 30 days following the last injection of palivizumab|||days||Standard Deviation|Mean
806627|NCT01006629|Secondary|Number of Intensive Care Unit (ICU) Admissions During RSV Hospitalization|Outcome measure refers to the number of subjects admitted to the ICU during RSV hospitalization. No RSV hospitalizations occurred during the study; therefore, evaluation of the secondary outcome measures was not possible.|Through 30 days following the last injection of palivizumab|||participants|||Number
806628|NCT01006629|Secondary|Total RSV Hospitalization Days With Increased Supplemental Oxygen Requirement|All secondary outcome measures were related to hospitalization due to RSV infection. No RSV hospitalizations occurred during the study; therefore, evaluation of the secondary outcome measures was not possible.|Through 30 days following the last injection of palivizumab|||days||Standard Deviation|Mean
806629|NCT01006629|Secondary|Total Number of RSV Hospitalization Days|All secondary outcome measures were related to hospitalization due to RSV infection. No RSV hospitalizations occurred during the study; therefore, evaluation of the secondary outcome measures was not possible.|Through 30 days following the last injection of palivizumab|||days||Standard Deviation|Mean
806630|NCT01006629|Primary|Number of Hospitalizations Due to Respiratory Syncytial Virus (RSV)|Number of subjects experiencing an RSV hospitalization|Through 30 days following the last injection of palivizumab|||participants||95% Confidence Interval|Number
806631|NCT01006629|Primary|Frequency of Adverse Events|Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 and 100 days after the last dose of study drug. The number of subjects experiencing a serious or nonserious treatment-emergent adverse event within 30 days after the last dose of study drug is summarized. See the Reported Adverse Events section for details.|Through 30 days following the last injection of palivizumab|||participants|||Number
806632|NCT01006655|Primary|Adenosine Challenge Test|Adenosine challenge test were measured and described as PC 20 - the concentration that corresponded to a FEV1 impairment equal or bigger than 20%. The stage was also recorded|ten weeks|||mg/ml||Standard Deviation|Mean
806633|NCT01014689|Secondary|Success Rate on the Investigator’s Global Assessment (IGA) at Week 12|Percentage of Subjects “Clear” or “Almost Clear” on 6-point IGA scale(0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe and 5=very severe) at Week 12.|Baseline and Week 12|Intention To treat - Last Observation Carried Forward||percent of subjects|||Number
806634|NCT01014689|Primary|Percent Change From Baseline in Total Lesion Count|Percent change from Baseline in Total Lesion count (sum of Non-Inflammatory and Inflammatory lesions) at Week 12.|Baseline and Week 12|Intention to treat - Last observation carried forward||percent of change||Full Range|Median
806635|NCT01014728|Secondary|Surgeon’s Numeric Rating Scale (SNRS)|The surgeon’s numeric rating scale(SNRS)is to rate the surgical conditions (mucosal bleeding and visibility) on a scale ranging from 0 to 10, with 0 defined as cadaveric conditions and 10 as severe bleeding requiring constant suction.|at the end of surgery (up to 6 hours)|There were three patients in the inhalation anesthesia group with missing values.||units on a scale||Full Range|Median
806636|NCT01014728|Secondary|Anesthesiologist Numeric Rating Scale (ANRS)|The anesthesiologist numeric rating scale is to rate the ease of the anesthesia technique ranging from 0 to 10 (10 is best, 0 is worst).|at the end of surgery (up to 6 hours)|There were three patients in the inhalation anesthesia group with missing values.||units on a scale||Full Range|Median
806637|NCT01014728|Primary|Estimated Blood Loss|Estimated blood loss in milliliters per hour is calculated by subtracting the volume of total irrigation used during the case from the total amount of fluid in the suction canister at the end of surgery and dividing by surgical time in hours.|from the start of surgery to the end of surgery, up to 6 hours|||mL/h||Standard Deviation|Mean
806638|NCT01014741|Secondary|Radiofrequency Ablation Time||at time of the procedure|||minutes||Standard Deviation|Mean
806639|NCT01014741|Secondary|AF Termination|AF termination with complex fractionated atrial electrograms (CFAE) ablation|at time of the procedure|||participants|||Number
806640|NCT01014741|Secondary|Procedure Time|Overall procedure duration|at time of the procedure|||minutes||Standard Deviation|Mean
806641|NCT01014741|Primary|1 Year Freedom From AF / AT|Freedom from atrial arrhythmia after repeat procedures with or without drugs|one year|Ninety-two patients in the ibutilide group and 93 patients in the placebo group remained in AF after study drug administration and underwent CFAE ablation.||participants|||Number
806642|NCT01014871|Primary|Severity of the Forehead Wrinkles by the Evaluator at Maximum Contraction and at Rest Using the Forehead Wrinkles Severity Scale (0 to 3) at Each Study Visit and for Each Side of the Forehead|Bilateral comparison of forehead wrinkle severity score at rest and at maximum contraction measured by Forehead Wrinkles Severity Scale (0 to 3) at each study visit (Baseline, Days 1, 2, 3, 7, 10, 14, 30, Months 4 and 5)and for each side.|5 months : Baseline, Days 1, 2, 3, 7, 10, 14, 30, Months 4 and 5|Intention To Treat||Scores on a scale||Standard Deviation|Mean
806643|NCT01014910|Secondary|Clinical Deterioration Necessitating Transfer to Higher Level of Care||Summarized from admission to hospital discharge|||participants|||Number
806644|NCT01014910|Primary|Length of Stay in the Hospital||Summarized from admission to hospital discharge|||hours||Inter-Quartile Range|Median
806645|NCT01014936|Secondary|Progression-free Survival (PFS)|PFS was defined as the time (in months) between the first dosing day and radiographic PD or clinical PD (as recorded on the study termination form) or death, if death occurred within 12 weeks (84 days) after the last tumor assessment without documented progressive disease, whichever occurred first. Any subject with neither assessment of tumor progression, nor death within 12 weeks after last tumor assessment date was censored on the date of last tumor assessment.|Baseline up to 153.3 weeks|"Safety set included all subjects who had received at least 1 dose of MSC2156119J treatment. Here, Number of Participants Analyzed signifies those subjects who were evaluable for this outcome measure."||months||90% Confidence Interval|Median
806646|NCT01014936|Secondary|Number of Subjects With Best Overall Response (BOR)|Number of subjects with BOR in each category (complete response [CR], partial response [PR], stable disease [SD], progressive disease [PD]) according to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) was reported. CR: defined as disappearance of all target and all non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: defined as at least a 30% decrease in sum of longest diameter of target lesions, taking as reference the baseline sum of longest diameter. PD:defined as at least a 20% increase in sum of longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or unequivocal progression of existing non-target lesions. SD: defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of longest diameter while on study.|Baseline up to 153.3 weeks|Safety set included all subjects who had received at least 1 dose of MSC2156119J treatment.||subjects|||Number
806647|NCT01014936|Secondary|Relative Percentage Change In Sum of Longest Diameter (SOLD) of Target Lesions to Post-Baseline Nadir|The post-baseline nadir was defined as the the smallest SOLD recorded after baseline. The relative change (%) was derived based on the SOLD of target lesions as follows: 100* (SOLD at post-baseline nadir - baseline SOLD) / baseline SOLD.|Baseline, On Treatment (up to 153.3 weeks)|Safety set included all subjects who had received at least 1 dose of MSC2156119J treatment. Here “Number of Participants Analyzed” signifies those subjects who presented a measurable tumor at baseline and at least one post-baseline tumor assessment.||percent change||Standard Deviation|Mean
806648|NCT01014936|Secondary|Number of Subjects With Monovalent Antagonist Antibody to Receptor MET (MetMAb) Score (MMS)|MetMAb score was used to assess the tumor c-Met expression and ranged from 0 to 3, where a score of 0 corresponds to the lowest c-Met expression and a score of 3 corresponds to the highest c-Met expression in tumor tissue by immunohistochemistry.|Day 1 Cycle 2|Safety set included all subjects who had received at least 1 dose of MSC2156119J treatment.||subjects|||Number
806649|NCT01014936|Secondary|Fold Change From Baseline in Cytoplasm and Membrane H-Score at Day 1 Cycle 2|Histo score (H-score) is a composite score that comprises of intensity and percentage of staining and is used for assessing the amount of protein or phospho-protein present in a biopsy sample. The composite score obtained by H-score is derived by summing the percentages of cell staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+; where 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). The composite H-score ranges from 0 to 300, with a score of 0 representing the absence of any of the target protein and an H-score of 300 representing maximum staining and intensity of the target protein. Fold change = on-treatment value/ baseline value|Baseline, Day 1 Cycle 2|Safety set included all subjects who had received at least 1 dose of MSC2156119J treatment. Here “Number of Participants analyzed” signifies those subjects who were evaluable for this outcome and “n” signifies those subjects who were evaluable in the specified category for each arm, respectively.||fold change||Standard Deviation|Mean
806650|NCT01014936|Secondary|Absolute Change From Baseline in Cytoplasm and Membrane H-Score at Day 1 Cycle 2|Histo score (H-score) is a composite score that comprises of intensity and percentage of staining and is used for assessing the amount of protein or phospho-protein present in a biopsy sample. The composite score obtained by H-score is derived by summing the percentages of cell staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+; where 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). The composite H-score ranges from 0 to 300, with a score of 0 representing the absence of any of the target protein and an H-score of 300 representing maximum staining and intensity of the target protein.|Baseline, Day 1 Cycle 2|Safety set included all subjects who had received at least 1 dose of MSC2156119J treatment. Here, “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure.||units on a scale||Standard Deviation|Mean
806651|NCT01014936|Secondary|Apparent Terminal Rate Constant (λz) After Multiple Dose of MSC2156119J: Regimen 3|Apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant.|||||
806652|NCT01014936|Secondary|Apparent Terminal Rate Constant (λz) After Multiple Dose of MSC2156119J: Regimen 2|Apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 19 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant.|||||
806761|NCT01016691|Primary|Mean Change in Intraocular Pressure at Day 1||Baseline to Day 1|per-protocol population||mmHg||Standard Deviation|Mean
806654|NCT01014936|Secondary|Apparent Terminal Rate Constant (λz) After Single Dose of MSC2156119J: Regimen 3|Apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant.|||||
806655|NCT01014936|Secondary|Apparent Terminal Rate Constant (λz) After Single Dose of MSC2156119J: Regimen 2|Apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant.|||||
806656|NCT01014936|Secondary|Apparent Terminal Rate Constant (λz) After Single Dose of MSC2156119J: Regimen 1|Apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant.|||||
806657|NCT01014936|Secondary|Apparent Volume of Distribution (Vz/f) After Multiple Dose of MSC2156119J: Regimen 3|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/AUC0-inf multiplied by λz.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of Vz/f.|||||
806658|NCT01014936|Secondary|Apparent Volume of Distribution (Vz/f) After Multiple Dose of MSC2156119J: Regimen 2|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/AUC0-inf multiplied by λz.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 19 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of Vz/f.|||||
806659|NCT01014936|Secondary|Apparent Volume of Distribution (Vz/f) After Multiple Dose of MSC2156119J: Regimen 1|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/AUC0-inf multiplied by λz.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of Vz/f.|||||
806660|NCT01014936|Secondary|Apparent Volume of Distribution (Vz/f) After First Dose of MSC2156119J: Regimen 3|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/AUC0-inf multiplied by λz.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of Vz/f.|||||
806661|NCT01014936|Secondary|Apparent Volume of Distribution (Vz/f) After First Dose of MSC2156119J: Regimen 2|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/AUC0-inf multiplied by λz.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of Vz/f.|||||
806662|NCT01014936|Secondary|Apparent Volume of Distribution (Vz/f) After First Dose of MSC2156119J: Regimen 1|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/AUC0-inf multiplied by λz.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of Vz/f.|||||
806663|NCT01014936|Secondary|Apparent Body Clearance (CL/f) After First Dose of MSC2156119J: Regimen 3|Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent body clearance of the drug from plasma, CL= Dose/AUC0−inf.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of CL/f.|||||
806664|NCT01014936|Secondary|Apparent Body Clearance (CL/f) After First Dose of MSC2156119J: Regimen 2|Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent body clearance of the drug from plasma, CL= Dose/AUC0−inf.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of CL/f.|||||
806665|NCT01014936|Secondary|Apparent Body Clearance (CL/f) After First Dose of MSC2156119J: Regimen 1|Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent body clearance of the drug from plasma, CL= Dose/AUC0−inf.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of CL/f.|||||
806666|NCT01014936|Secondary|Area Under Plasma Concentration Versus Time Curve Within One Dosing Interval (AUCtau) After Multiple Dose of MSC2156119: Regimen 3|"Reporting group MSC2156119J 1200 mg: Fasted is not applicable for Multiple Dosing because only one subject was erroneously dosed with 1200 mg in fasted state as a single dose in Regimen 3. For multiple dose PK profile (Study Day 14), this subject was included in reporting group MSC2156119J 1400 mg: Fed."|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1|PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose. Here, “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure.||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
806667|NCT01014936|Secondary|Area Under Plasma Concentration Versus Time Curve Within One Dosing Interval (AUCtau) After Multiple Dose of MSC2156119: Regimen 2||pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24, 48 hours post-dose on Day 19 Cycle 1|PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose. Here, “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure.||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
806668|NCT01014936|Secondary|Area Under Plasma Concentration Versus Time Curve Within One Dosing Interval (AUCtau) After Multiple Dose of MSC2156119: Regimen 1||pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1|PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose. Here, “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure.||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
806669|NCT01014936|Secondary|Area Under Plasma Concentration Versus Time Curve Within One Dosing Interval (AUCtau) After Single Dose of MSC2156119: Regimen 3||pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose. Here, “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure.||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
806670|NCT01014936|Secondary|Area Under Plasma Concentration Versus Time Curve Within One Dosing Interval (AUCtau) After Single Dose of MSC2156119: Regimen 2||pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24, 48 hours post-dose on Day 1 Cycle 1|PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose. Here, “Number Participants Analyzed” signifies those subjects who were evaluable for this outcome measure.||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
806671|NCT01014936|Secondary|Area Under Plasma Concentration Versus Time Curve Within One Dosing Interval (AUCtau) After Single Dose of MSC2156119: Regimen 1||pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose. Here, “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure.||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
806672|NCT01014936|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) After Single Dose Of MSC2156119J: Regimen 3|AUC0-inf was calculated by combining AUC0-t and AUCextra. AUCextra represents an extrapolated value obtained by Clast/ λz, where Clast is the calculated plasma concentration at the last sampling time point at which the measured plasma concentration is at or above the LLQ and λz is the apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of AUC0-inf.|||||
806673|NCT01014936|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) After Single Dose Of MSC2156119J: Regimen 2|AUC0-inf was calculated by combining AUC0-t and AUCextra. AUCextra represents an extrapolated value obtained by Clast/ λz, where Clast is the calculated plasma concentration at the last sampling time point at which the measured plasma concentration is at or above the LLQ and λz is the apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of AUC0-inf.|||||
806674|NCT01014936|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) After Single Dose Of MSC2156119J: Regimen 1|AUC0-inf was calculated by combining AUC0-t and AUCextra. AUCextra represents an extrapolated value obtained by Clast/ λz, where Clast is the calculated plasma concentration at the last sampling time point at which the measured plasma concentration is at or above the LLQ and λz is the apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of AUC0-inf.|||||
806675|NCT01014936|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Sampling Time (AUC0-t) After Multiple Dose of MSC2156119J : Regimen 3|"Area under the plasma concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the LLQ. AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule. Reporting group MSC2156119J 1200 mg: Fasted is not applicable for Multiple Dosing because only one subject was erroneously dosed with 1200 mg in fasted state as a single dose in Regimen 3. For multiple dose PK profile (Study Day 14), this subject was included in reporting group MSC2156119J 1400 mg: Fed."|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1|PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose.||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
806676|NCT01014936|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Sampling Time (AUC0-t) After Multiple Dose of MSC2156119J : Regimen 2|Area under the plasma concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the LLQ. AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 19 Cycle 1|PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose. Here, “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure.||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
806677|NCT01014936|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Sampling Time (AUC0-t) After Multiple Dose of MSC2156119J : Regimen 1|Area under the plasma concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the LLQ. AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1|PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose. Here, “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure.||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
806678|NCT01014936|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Sampling Time (AUC0-t) After First Dose of MSC2156119J: Regimen 3|Area under the plasma concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the LLQ. AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose.||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
806679|NCT01014936|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Sampling Time (AUC0-t) After First Dose of MSC2156119J: Regimen 2|Area under the plasma concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the LLQ. AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose.||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
806680|NCT01014936|Secondary|Area Under Plasma Concentration Versus Time Curve From Time Zero to Last Sampling Time (AUC0-t) After First Dose of MSC2156119J: Regimen 1|Area under the plasma concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLQ). AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose.||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
806681|NCT01014936|Secondary|Apparent Terminal Half-life (t1/2) After Multiple Dose Of MSC2156119J: Regimen 3|Apparent terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by λz.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of t1/2.|||||
806682|NCT01014936|Secondary|Apparent Terminal Half-life (t1/2) After Multiple Dose Of MSC2156119J: Regimen 2|Apparent terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by λz.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 19 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of t1/2.|||||
806683|NCT01014936|Secondary|Apparent Terminal Half-life (t1/2) After Multiple Dose Of MSC2156119J: Regimen 1|Apparent terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by λz.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of t1/2.|||||
806684|NCT01014936|Secondary|Apparent Terminal Half-life ( t1/2) After Single Dose Of MSC2156119J: Regimen 3|Apparent Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by λz.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of t1/2.|||||
806685|NCT01014936|Secondary|Apparent Terminal Half-life ( t1/2) After Single Dose Of MSC2156119J: Regimen 2|Apparent Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by λz.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of t1/2.|||||
806686|NCT01014936|Secondary|Apparent Terminal Half-life ( t1/2) After Single Dose Of MSC2156119J: Regimen 1|Apparent Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by λz.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of t1/2.|||||
806762|NCT01016834|Secondary|Treatment Confidence|Number of subjects who indicated they were confident or very confident in treating repeated migraine attacks with Sumavel DosePro at end of treatment.|After 4 migraines or 60 days|||participants|||Number
806687|NCT01014936|Secondary|Time To Reach Maximum Plasma Concentration (Tmax) After Multiple Dose of MSC2156119J: Regimen 3|"Reporting group MSC2156119J 1200 mg: Fasted is not applicable for Multiple Dosing because only one subject was erroneously dosed with 1200 mg in fasted state as a single dose in Regimen 3. For multiple dose PK profile (Study Day 14), this subject was included in reporting group MSC2156119J 1400 mg: Fed."|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1|PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose. Here, “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure.||hours||Full Range|Median
806688|NCT01014936|Secondary|Time To Reach Maximum Plasma Concentration (Tmax) After Multiple Dose of MSC2156119J: Regimen 2||pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 19 Cycle 1|PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose. Here, “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure||hours||Full Range|Median
806689|NCT01014936|Secondary|Time To Reach Maximum Plasma Concentration (Tmax) After Multiple Dose of MSC2156119J: Regimen 1||pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1|PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose. Here, “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure.||hours||Full Range|Median
806690|NCT01014936|Secondary|Time To Reach Maximum Plasma Concentration (Tmax) After Single Dose of MSC2156119J: Regimen 3||pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose.||hours||Full Range|Median
806691|NCT01014936|Secondary|Time To Reach Maximum Plasma Concentration (Tmax) After Single Dose of MSC2156119J: Regimen 2||pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24, 48, 49.32 hours post-dose on Day 1 Cycle 1|PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose.||hours||Full Range|Median
806692|NCT01014936|Secondary|Time To Reach Maximum Plasma Concentration (Tmax) After Single Dose of MSC2156119J: Regimen 1||pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose.||hours||Full Range|Median
806693|NCT01014936|Secondary|Observed Maximum Plasma Concentration (Cmax) After Multiple Dose of MSC2156119J: Regimen 3|"Reporting group MSC2156119J 1200 mg: Fasted is not applicable for Multiple Dosing because only one subject was erroneously dosed with 1200 mg in fasted state as a single dose in Regimen 3. For multiple dose PK profile (Study Day 14), this subject was included in reporting group MSC2156119J 1400 mg: Fed."|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1|PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose. Here, “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
806694|NCT01014936|Secondary|Observed Maximum Plasma Concentration (Cmax) After Multiple Dose of MSC2156119J: Regimen 2||pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 19 Cycle 1|PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose. Here, “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
806695|NCT01014936|Secondary|Observed Maximum Plasma Concentration (Cmax) After Multiple Dose of MSC2156119J: Regimen 1||pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1|PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose. Here, “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
806696|NCT01014936|Secondary|Observed Maximum Plasma Concentration (Cmax) After Single Dose of MSC2156119J: Regimen 3||pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
806697|NCT01014936|Secondary|Observed Maximum Plasma Concentration (Cmax) After Single Dose of MSC2156119J: Regimen 2||pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
806698|NCT01014936|Secondary|Observed Maximum Plasma Concentration (Cmax) After Single Dose of MSC2156119J: Regimen 1||pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|Pharmacokinetic (PK) analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose.||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
806699|NCT01014936|Secondary|Number of Subjects With Treatment-Emergent AEs (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation or TEAEs Leading to Death|AE was defined as any untoward medical occurrence which does not necessarily have a causal relationship with this the study drug. An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious AE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent are events between first dose of study drug and up to 33 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. TEAEs include both Serious TEAEs and non-serious TEAEs.|Baseline up to 158.01 weeks|Safety set included all subjects who had received at least 1 dose of MSC2156119J treatment.||subjects|||Number
806701|NCT01014936|Primary|Recommended Phase 2 Dose (RP2D)|MTD was defined as the dose level at which 2 out of 3 subjects or 2 out of 6 subjects experienced a DLT. The primary endpoint was to determine MTD of MSC2156119J for each of the 3 treatment regimens in subjects with advanced solid tumors. However, during the course of the trial it was established that the MTD could not be determined and instead, RP2D was to be determined.|Cycle 1 (Day 1 to Day 21)|DLT analysis set comprised of subjects who had either completed Cycle 1 or had stopped treatment because of a DLT during Cycle 1.||milligram|||Number
806702|NCT01014936|Primary|Number of Subjects With Any Dose Limiting Toxicity (DLT)|DLT was defined as one of the following adverse events (AEs) observed during Cycle1, regardless of MSC2156119J relationship, excluding AEs assessed by investigator exclusively related to subject’s underlying disease or medical condition: Grade 4 neutropenia for >7 days; Grade >=3 febrile neutropenia for >1 day; Grade 4 thrombocytopenia/Grade 3 with bleeding; Grade >=3 nausea and emesis, despite optimal treatment; Grade >=3 non-hematological AE, except emesis and nausea with no adequate therapy and alopecia, Grade >= 3 liver AE with a recovery period of >7 days or to Grade <=1 for subjects without liver metastases or to <=2 for subjects with liver metastases; Grade >=3 lipase and/or amylase rise with pancreatitis confirmation, either based on clinical or radiological signs. Any AE not otherwise defined as a DLT that, due to prolonged recovery to Grade <=1 or baseline status, leads to delay of above 21 days in planned administration of study drug.|Day 1, 3, 8, 14, 17 of Cycle 1 (for Regimen 1 and 3); Day 1, 3, 8, 15, 19 of Cycle 1 (for Regimen 2)|DLT analysis set comprised of subjects who had either completed Cycle 1 or had stopped treatment because of a DLT during Cycle 1.||subjects|||Number
806703|NCT01016483|Secondary|Phase II: Volume of Central Compartment (V1/f) and Volume of Peripheral Compartment (V2/f) of Pimasertib (MSC1936369B)||Baseline, every 8 weeks up to EOT (6 years)|As per change in planned analysis, there was reduction of PK investigations for the phase II part of the trial, removal of PK sampling for gemcitabine and its metabolites and replacement of intense sampling with a sparse sampling scheme for pimasertib, thus the outcome measure was not analyzed.|||||
806704|NCT01016483|Secondary|Phase II: Clearance From Central Compartment (CL/f) and Intercompartmental Clearance (Q/f) of Pimasertib (MSC1936369B)||Baseline, every 8 weeks up to EOT (6 years)|As per change in planned analysis, there was reduction of PK investigations for the phase II part of the trial, removal of PK sampling for gemcitabine and its metabolites and replacement of intense sampling with a sparse sampling scheme for pimasertib, thus the outcome measure was not analyzed.|||||
806705|NCT01016483|Secondary|Phase II: Absorption Rate Constant (ka) of Pimasertib (MSC1936369B)||Baseline, every 8 weeks up to EOT (6 years)|As per change in planned analysis, there was reduction of PK investigations for the phase II part of the trial, removal of PK sampling for gemcitabine and its metabolites and replacement of intense sampling with a sparse sampling scheme for pimasertib, thus the outcome measure was not analyzed.|||||
806706|NCT01016483|Secondary|Phase II: Overall Survival (OS) Time|Overall survival (OS) time is defined as the time (in months) from randomization to death.|Baseline, every 8 weeks up to EOT (6 years)|ITT analysis set included all subjects who had been randomized for the phase II part, as per the interactive voice response system (IVRS).||months||95% Confidence Interval|Median
806707|NCT01016483|Secondary|Phase II: Time to Progression (TTP)|Time to progression (TTP) is defined as the time (in months) from the randomization date to the date of progression prior to the start of any subsequent therapy for the primary disease, as reported and documented by the Investigator (i.e. radiological progression per RECIST).|From randomization every 8 weeks up to EOT (6 years)|ITT analysis set included all subjects who had been randomized for the phase II part, as per the interactive voice response system (IVRS).||months||95% Confidence Interval|Median
806708|NCT01016483|Secondary|Phase II: Percentage of Subjects With Clinical Benefit|Clinical Benefit was defined as the presence of at least one CR, PR or Stable Disease (SD) (using RECIST v1.0) during treatment. CR: Disappearance of all target lesions, PR: At least 30% decrease in the sum of the longest diameter of target lesions, taking as reference the sum of the longest diameter at baseline and SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of the longest diameter since treatment started.|Baseline, every 8 weeks up to end of treatment (EOT i.e. 6 years)|ITT analysis set included all subjects who had been randomized for the phase II part, as per the interactive voice response system (IVRS).||percentage of subjects|||Number
806709|NCT01016483|Secondary|Phase II: Percentage of Subjects With Best Overall Response (BOR)|Best overall response was defined as the presence of at least one complete response (CR), partial response (PR) or Stable Disease (SD) (using RECIST v1.0) during treatment. CR: Disappearance of all target lesions, PR: At least 30% decrease in the sum of the longest diameter of target lesions, taking as reference the sum of the longest diameter at baseline and SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of the longest diameter since treatment started.|Baseline, every 8 weeks up to end of treatment (EOT i.e. 6 years)|ITT analysis set included all subjects who had been randomized for the phase II part, as per the interactive voice response system (IVRS).||percentage of subjects|||Number
806710|NCT01016483|Secondary|Phase II: Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Permanent Treatment Discontinuation|An AE was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. All AEs (serious and non-serious) except AEs recorded with an onset date prior to the first day of drug administration unless a worsening of the event was recorded after the first dosing date, in which case the event was counted as a TEAE. TEAEs include both SAEs and non-SAEs.|From the first dose of study drug administration until EOT (6 years)|SAF for the Phase II included all subjects who had received at least 1 administration of the trial medication Gemcitabine or Placebo if the subject is in the gemcitabine + Placebo treatment arm (Arm 1) and MSC1936369B or gemcitabine in the MSC1936369B + gemcitabine treatment arm (Arm 2).||subjects|||Number
806740|NCT01016600|Secondary|CR With Incomplete Blood Counts Rate|Defined as CR with the exception of neutropenia <1000/uL or thrombocytopenia <100,000/ul.|Completion of treatment (median follow-up was 8 weeks) (range 4-68 weeks)|(3) participants in Cohort 1, (1) participant in Cohort 2, and (3) participants in Phase II did not receive 28 days of lenalidomide and therefore are not evaluable for response.||participants|||Number
806711|NCT01016483|Secondary|Safety Run-In Part: Levels of Pharmacodynamic (Pd) Markers (Phosphorylated- Extracellular Signal-Regulated Kinase (ERK) in Peripheral Blood Mononuclear Cells [PBMCs]): Regimen 2|ERK phosphoprotein in peripheral blood monocytes (PBMCs) was analyzed from blood samples of all subjects in the SAF analysis set (safety-run part) only.|pre-dose on Day 1, 2, 22 of Cycle 1; post-dose on Day 1, 22 of Cycle 1|"Pharmacodynamic population included SAF analysis set for the safety run-in part include all subjects who received at least 1 (non-zero) administration of the trial medication (pimasertib or gemcitabine). Here n signifies those subjects who were evaluable at the specified time point for each arm respectively."||Fluorescence Intensity||Standard Deviation|Mean
806712|NCT01016483|Secondary|Safety Run-In Part: Oral Volume of Distribution (V/f) of Pimasertib (MSC1936369B): Regimen 2|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.|0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1|PKS set of the safety run in part included subjects who had received at least the first dose of both drugs (i.e. gemcitabine and pimasertib), and provided PK samples as per the protocol for at least 24 hours following first dosing on Day 1. Here “n” signifies number of subjects evaluable for each category at specified time point.||liter||Geometric Coefficient of Variation|Geometric Mean
806713|NCT01016483|Secondary|Safety Run-In Part: Apparent Volume of Distribution (V) of Gemcitabine: Regimen 2|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.|0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1|PKS set of the safety run in part included subjects who had received at least the first dose of both drugs (i.e., gemcitabine and pimasertib), and provided PK samples as per the protocol for at least 24 hours following first dosing on Day 1. Here “n” signifies number of subjects evaluable for each category at specified time point.||liter||Geometric Coefficient of Variation|Geometric Mean
806714|NCT01016483|Secondary|Safety Run-In Part: Total Clearance (CL) of Gemcitabine: Regimen 2|Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.|0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1|PKS set of the safety run in part included subjects who had received at least the first dose of both drugs (i.e., gemcitabine and pimasertib), and provided PK samples as per the protocol for at least 24 hours following first dosing on Day 1. Here “n” signifies number of subjects evaluable for each category at specified time point.||liter/hour||Geometric Coefficient of Variation|Geometric Mean
806715|NCT01016483|Secondary|Safety Run-In Part: Apparent Oral Clearance (CL/f) of Pimasertib (MSC1936369B): Regimen 2|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.|0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1|PKS set of the safety run in part included subjects who had received at least the first dose of both drugs (i.e., gemcitabine and pimasertib), and provided PK samples as per the protocol for at least 24 hours following first dosing on Day 1. Here “n” signifies number of subjects evaluable for each category at specified time point.||Liter per hour (L/H)||Geometric Coefficient of Variation|Geometric Mean
806716|NCT01016483|Secondary|Safety Run-In Part: Time to Reach Apparent Terminal Half-Life (t1/2) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU): Regimen 2|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1|PKS set of the safety run in part included subjects who had received at least the first dose of both drugs (i.e., gemcitabine and pimasertib), and provided PK samples as per the protocol for at least 24 hours following first dosing on Day 1. Here “n” signifies number of subjects evaluable for each category at specified time point.||hours||Full Range|Median
806717|NCT01016483|Secondary|Safety Run-In Part: Time to Reach Maximum Concentration (Tmax) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU): Regimen 2||0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1|PKS set of the safety run in part included subjects who had received at least the first dose of both drugs (i.e., gemcitabine and pimasertib), and provided PK samples as per the protocol for at least 24 hours following first dosing on Day 1.Here “n” signifies number of subjects evaluable for each category at specified time point.||hours||Full Range|Median
806718|NCT01016483|Secondary|Safety Run-In Part: Area Under Curve (AUC:0 to Infinity) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU) Regimen 2|AUC:0 to infinity is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.|0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1 of Cycle 1 for MSC1936369B, 0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1 for Gemcitabine|PKS of the safety run in part included subjects who had received at least the first dose of both drugs (i.e., gemcitabine and pimasertib), and provided PK samples as per the protocol for at least 24 hours following first dosing on Day 1. Here “n” signifies number of subjects evaluable for each category at specified time point.||hour*nanogram per milliliter (h*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
806719|NCT01016483|Secondary|Safety Run-In Part: Maximum Concentration (Cmax) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU): Regimen 2||0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1|PKS of the safety run in part included subjects who had received at least the first dose of both drugs (i.e., gemcitabine and pimasertib), and provided PK samples as per the protocol for at least 24 hours following first dosing on Day 1. Here “n” signifies number of subjects evaluable for each category at specified time point.||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
806741|NCT01016600|Secondary|Cytogenetic CR (CRc) Rate|Only patients with an identified cytogenetic abnormality may receive this designation. Defines as a morphologic complete remission plus reversion to a normal karyotype (no clonal abnormalities detected in a minimum of 20 mitotic cells).|Completion of treatment (median follow-up was 8 weeks) (range 4-68 weeks)|(3) participants in Cohort 1, (1) participant in Cohort 2, and (3) participants in Phase II did not receive 28 days of lenalidomide and therefore are not evaluable for response.||participants|||Number
806720|NCT01016483|Secondary|Safety Run-In Part: Levels of Pharmacodynamic (Pd) Markers (Phosphorylated- Extracellular Signal-Regulated Kinase (ERK) in Peripheral Blood Mononuclear Cells [PBMCs]): Regimen 1|ERK phosphoprotein in peripheral blood monocytes (PBMCs) was analyzed from blood samples of all subjects in the SAF analysis set (safety-run part) only.|pre-dose on Day 1, 2, 22 of Cycle 1; post-dose on Day 1, 22 of Cycle 1|"Pharmacodynamic population included SAF analysis set for the safety run-in part include all subjects who received at least 1 (non-zero) administration of the trial medication (pimasertib or gemcitabine). Here n signifies those subjects who were evaluable at the specified time point for each arm, respectively."||Fluorescence Intensity||Standard Deviation|Mean
806721|NCT01016483|Secondary|Safety Run-In Part: Apparent Volume of Distribution (V) of Gemcitabine: Regimen 1|Apparent volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.|0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1|PKS set of the safety run in part included subjects who had received at least the first dose of both drugs (i.e., gemcitabine and pimasertib), and provided PK samples as per the protocol for at least 24 hours following first dosing on Day 1. Here “n” signifies number of subjects evaluable for each category at specified time point.||liter||Geometric Coefficient of Variation|Geometric Mean
806722|NCT01016483|Secondary|Safety Run-In Part: Oral Volume of Distribution (V/f) of Pimasertib (MSC1936369B): Regimen 1|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.|0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1|PKS set of the safety run in part included subjects who had received at least the first dose of both drugs (i.e., gemcitabine and pimasertib), and provided PK samples as per the protocol for at least 24 hours following first dosing on Day 1. Here “n” signifies number of subjects evaluable for each category at specified time point.||liter||Geometric Coefficient of Variation|Geometric Mean
806723|NCT01016483|Secondary|Safety Run-In Part: Total Clearance (CL) of Gemcitabine: Regimen 1|Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.|0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1|"PKS set of the safety run in part included subjects who had received at least the first dose of both drugs (i.e., gemcitabine and pimasertib), and provided PK samples as per the protocol for at least 24 hours following first dosing on Day 1. Here n signifies those subjects who were evaluable at the specified time point."||liter/hour||Geometric Coefficient of Variation|Geometric Mean
806724|NCT01016483|Secondary|Safety Run-In Part: Apparent Oral Clearance (CL/f) of Pimasertib (MSC1936369B): Regimen 1|Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) was influenced by the fraction of the dose absorbed.|0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1|PKS set of the safety run in part included subjects who had received at least the first dose of both drugs (i.e., gemcitabine and pimasertib), and provided PK samples as per the protocol for at least 24 hours following first dosing on Day 1. Here “n” signifies number of subjects evaluable for each category at specified time point.||Liter per hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
806725|NCT01016483|Secondary|Safety Run-In Part: Area Under Curve (AUC: 0 to Infinity) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU): Regimen 1|AUC:0 to infinity was a measure of the serum concentration of the drug over time. It was used to characterize drug absorption.|0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1 of Cycle 1 for MSC1936369B, 0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1 for Gemcitabine|PKS of the safety run in part included subjects who had received at least the first dose of both drugs (i.e., gemcitabine and pimasertib), and provided PK samples as per the protocol for at least 24 hours following first dosing on Day 1. Here “n” signifies number of subjects evaluable for each category at specified time point.||hour*nanogram per milliliter (h*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
806726|NCT01016483|Secondary|Safety Run-In Part: Time to Reach Apparent Terminal Half-Life (t1/2) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU): Regimen 1|Plasma decay half-life was the time measured for the plasma concentration to decrease by one half.|0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1|PKS set of the safety run in part included subjects who had received at least the first dose of both drugs (i.e., gemcitabine and pimasertib), and provided PK samples as per the protocol for at least 24 hours following first dosing on Day 1. Here “n” signifies number of subjects evaluable for each category at specified time point.||hours||Full Range|Median
806727|NCT01016483|Secondary|Safety Run-In Part: Time to Reach Maximum Concentration (Tmax) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU): Regimen 1||0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1|PKS set of the safety run in part included subjects who had received at least the first dose of both drugs (i.e., gemcitabine and pimasertib), and provided PK samples as per the protocol for at least 24 hours following first dosing on Day 1. Here “n” signifies number of subjects evaluable for each category at specified time point.||hours||Full Range|Median
806728|NCT01016483|Secondary|Safety Run-In Part: Maximum Concentration (Cmax) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU) for Regimen 1||0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1|Pharmacokinetic set (PKS) of the safety run in part included subjects who had received at least the first dose of both drugs (i.e., gemcitabine and pimasertib), and provided PK samples as per the protocol for at least 24 hours following first dosing on Day1. Here “n” signifies number of subjects evaluable for each category at specified time point.||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
806754|NCT01016678|Primary|Percentage of Migraine Attacks With Pain Free Response at 2 Hours Post-Dose Following Early Intervention|All data was collected and measured from self-reported patient diaries|3 years|94 subjects treated at least one migraine attack with active drug or placebo were analyzed while only 74 subjects had the potential to take placebo during one of their 4 migraine attacks||percentage of attacks|Participants||Number
806877|NCT01017237|Secondary|Respiratory Parameters: Respiratory Rate|Respirations per minute|Immediately prior to sedation|Randomized per protocol||Breaths per Minute||Standard Deviation|Mean
806729|NCT01016483|Secondary|Safety Run-In Part: Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Permanent Treatment Discontinuation|An adverse event (AE) was any untoward medical occurrence in a subjects who received study drug without regard to possibility of causal relationship. An serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. All AEs (serious and non-serious) except AEs recorded with an onset date prior to the first day of drug administration unless a worsening of the event was recorded after the first dosing date, in which case the event was counted as a TEAE. TEAEs include both SAEs and non-SAEs.|From the first dose of study drug administration until EOT (6 years)|Safety analysis set (SAF) for the safety run-in part included all subjects who had received at least 1 administration of the trial medication (pimasertib or gemcitabine).||subjects|||Number
806730|NCT01016483|Primary|Phase II: Progression-Free Survival (PFS) Time|PFS was defined as the time from randomization to the first documentation of objective tumor progression (Complete Response (CR): Disappearance of all target lesions, Partial Response (PR): At least 30% decrease in the sum of the longest diameter of target lesions, taking as reference the sum of the longest diameter at baseline, Progressive Disease (PD): At least 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started, or the appearance of 1 or more new lesions and stable disease: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of the longest diameter since treatment started) or to death due to any cause, whichever occurred first. PFS calculated as (Months) = Date of first PD or death or censoring date minus date of randomization plus 1) divided by 30.4375.|From the time of randomization to every 8 weeks up to end of treatment (EOT) (6 years)|Intent to Treat (ITT) analysis set included all subjects who had been randomized for the phase II part, as per the interactive voice response system (IVRS).||months||95% Confidence Interval|Median
806731|NCT01016483|Primary|Safety Run-In Part: Number of Subjects With Dose Limiting Toxicities (DLTs)|DLT using the National Cancer Institute Common Terminology Criteria for Adverse Events(CTCAE) v3.0,was defined as any of the following toxicities at any dose level and judged to be possibly or probably related to trial medication by the Investigator and/or the Sponsor and relevant for the combination treatment: Grade 3/more non-hematological toxicity excluding: Subjects with liver involvement: Grade 4 asymptomatic increases in liver function tests and subject without liver involvement: Grade 3 asymptomatic increases in liver function tests reversible within 7 days. Grade 3 vomiting encountered despite adequate therapy. Grade 3 diarrhea encountered despite adequate anti diarrhea therapy. Grade 4 neutropenia greater (>) 5 days duration or febrile neutropenia lasting for more than 1 day. Grade 4 thrombocytopenia > 1 day/Grade 3 with bleeding. Grade 4 anemia: Any treatment delay > 2 weeks due to drug-related adverse effects.|Up to 28 days in Cycle 1|DLT analysis set included all subjects of safety run-in part who received any dose of pimasertib on at least 18 out of 20/25 out of 28 of the planned days on pimasertib & least 3 gemcitabine weekly infusions during first 28 days of treatment or experienced DLT during the 28 first days of treatment regardless of the amount of each drug received.||subjects|||Number
806732|NCT01016600|Primary|Phase II Only - Complete Remission Rate (CRm + CRi) in Participants With Untreated AML ≥60 Years of Age|"Morphologic complete remission (CRm): Defined as morphologic leukemia-free state, including <5% blasts in BM aspirate with marrow spicules and a count of > 200 nucleated cells and no blasts with Auer rods, no persistent extramedullary disease, ANC > 1000/uL, platelet count > 100,000/uL. Patient must be independent of transfusions for a minimum of 1 week before each marrow assessment.
Morphologic complete remission with incomplete blood count recovery (CRi): Defined as CR with the exception of neutropenia <1000/uL or thrombocytopenia <100,000/ul."|Completion of treatment (median follow-up was 8 weeks) (range 4-68 weeks)|Participants in Cohort 1, 2, and 3 were not analyzed for this outcome as it is a Phase II outcome measure only. (3) participants in Phase II cohort were not evaluable for response because they did not complete cycle 1.||percentage of participants|||Number
806733|NCT01016600|Secondary|Toxicity Profile (Grade 3/4 Toxicities)|AML ≥18 years or untreated AML ≥60 years|30 days after completion of treatment (median follow-up was 12 weeks (range 8-72 weeks))|||participants|||Number
806734|NCT01016600|Secondary|Duration of CR for Complete Responders||Completion of treatment (median follow-up was 8 weeks) (range 4-68 weeks)|(6) participants in Cohort 1, (3) participants in Cohort 2, (4) participants in Cohort 3, and (10) participants in Phase II did not have a complete response and are not evaluable for this outcome.||months||Full Range|Median
806735|NCT01016600|Secondary|Relapse Free Survival (RFS)|This is determined only for patients achieving a complete remission. Defined as the interval from the date of first documentation of a leukemia free state to date of recurrence or death due to any cause.|Until death - median follow-up 4.6 months (full range (0.3-31.4 months))|||months||Full Range|Median
806736|NCT01016600|Secondary|Time to Progression (TTP)|Defined as the interval from the date of the first dose of study drug to the date of progressive disease.|Until progressive disease - median follow-up 4.6 months (full range (0.3-31.4 months))|(2) cohort 1 participants were not evaluable for this outcome measure because (1) was removed for DLT & (1) withdrew from study. (2) phase II participants were not evaluable because both were removed from study in the first cycle for adverse events.||months||Full Range|Median
806737|NCT01016600|Secondary|Event Free Survival|Defined as the interval from the date of first dose of study drug to date of treatment failure, recurrence, or death due to any cause.|Until death - median follow-up 4.6 months (full range (0.3-31.4 months))|||months||Full Range|Median
806738|NCT01016600|Secondary|Overall Survival|Defined as the date of first dose of study drug to the date of death from any cause.|Until death - median follow-up 4.6 months (full range (0.3-31.4 months))|||months||Full Range|Median
806739|NCT01016600|Secondary|Partial Remission Rate (PR)|Requires that the criteria for complete remission be met with the following exceptions: decrease of >50% in the percentage of blasts to 5-25% in the BM aspirate. A value of < 5% blasts in BM with Auer rods is also considered a partial remission.|Completion of treatment (median follow-up was 8 weeks) (range 4-68 weeks)|(3) participants in Cohort 1, (1) participant in Cohort 2, and (3) participants in Phase II did not receive 28 days of lenalidomide and therefore are not evaluable for response.||participants|||Number
820512|NCT01144598|Secondary|Biologics Usage|Biologic treatments participants were taking for their rheumatoid arthritis.|Day 1|All participants with available information were included in the analysis.||Participants|||Number
806742|NCT01016600|Secondary|Morphologic Complete Remission Rate (CRm)|Defined as morphologic leukemia-free state, including <5% blasts in BM aspirate with marrow spicules and a count of > 200 nucleated cells and no blasts with Auer rods, no persistent extramedullary disease, ANC > 1000/uL, platelet count > 100,000/uL. Patient must be independent of transfusions for a minimum of 1 week before each marrow assessment. There is no duration requirement for this designation.|Completion of treatment (median follow-up was 8 weeks) (range 4-68 weeks)|(3) participants in Cohort 1, (1) participant in Cohort 2, and (3) participants in Phase II did not receive 28 days of lenalidomide and therefore are not evaluable for response.||participants|||Number
806743|NCT01016600|Secondary|Morphologic Leukemia-free State|Defined as < 5% blasts on the BM aspirate with spicules and a count of >200 nucleated cells and no blasts with Auer rods, and no persistent extramedullary disease.|Median number of cycles completed [3 cycles (12 weeks) full range (1 (4 weeks)-17 (68 weeks))]|(3) participants in Cohort 1, (1) participant in Cohort 2, and (3) participants in Phase II did not receive 28 days of lenalidomide and therefore are not evaluable for response.||participants|||Number
806744|NCT01016600|Secondary|Response Rate (CRm + CRc + CRi + PR)|"Response rate (CRm + CRc + CRi + PR)
CRm = morphologic complete remission
CRc = cytogenetic complete remission
CRi = morphologic complete remission with incomplete blood count recovery
PR = partial remission"|Median number of cycles completed [3 cycles (12 weeks) full range (1 (4 weeks)-17 (68 weeks))]|(3) participants in Cohort 1, (1) participant in Cohort 2, and (3) participants in Phase II did not receive 28 days of lenalidomide and therefore are not evaluable for response. (1) participant in Cohort one had both CRm and CRc.||participants|||Number
806745|NCT01016600|Primary|Phase I Only - Maximum Tolerated Dose (MTD)|"The maximum tolerated dose (MTD) is defined as the dose level immediately below the dose level at which 2 patients of a cohort (of 2 to 6 patients) experience dose-limiting toxicity during the first cycle.
Hematologic DLT is as a persistent bone marrow aplasia with ≤ 10 % cellularity, which persists for > 60 days from the start of a chemotherapy cycle.
Non-hematologic DLT is defined as any Grade 3 or Grade 4 non-hematologic toxicity that occurs during the first cycle with the specific exceptions of nausea, vomiting, anorexia, weight loss, infections or electrolyte abnormalities attributable to any other cause. Grade 3 triglycerides will be considered a DLT only for patients who have Grade 3 in spite of appropriate lipid lowering drug therapy."|Completion of the phase I portion of study (approximately 1 year and 4 months)|||mg/m^2|||Number
806746|NCT01016600|Primary|Phase I Only - Maximum Tolerated Dose (MTD) as Measured by Dose-limiting Toxicities (DLTs)|"The maximum tolerated dose (MTD) is defined as the dose level immediately below the dose level at which 2 patients of a cohort (of 2 to 6 patients) experience dose-limiting toxicity during the first cycle.
Hematologic DLT is as a persistent bone marrow aplasia with ≤ 10 % cellularity, which persists for > 60 days from the start of a chemotherapy cycle.
Non-hematologic DLT is defined as any Grade 3 or Grade 4 non-hematologic toxicity that occurs during the first cycle with the specific exceptions of nausea, vomiting, anorexia, weight loss, infections or electrolyte abnormalities attributable to any other cause. Grade 3 triglycerides will be considered a DLT only for patients who have Grade 3 in spite of appropriate lipid lowering drug therapy."|Completion of the phase I portion of study (approximately 1 year and 4 months)|(1) participant in Cohort 1 did not start treatment. The Phase II cohort was not analyzed because this was a Phase I outcome only.||dose-limiting toxicities|||Number
806747|NCT01016652|Secondary|Proportion of Subjects Benefiting From the Binocular +/-1.00D Accommodative Flipper|Utility of the use of the Binocular +/-1.00D accommodative flipper as a screening tool for those emerging presbyopia subjects|Baseline|Analysis was on those subjects who were randomized to either treatment arm with the intent to treat.||percentage of participants|||Number
806748|NCT01016652|Secondary|Comfortable Wearing Time|Comfortable wearing time was measured using self-reported subject awareness of irritation at a given time of day, rounded to the nearest half-hour. Could be described as aware of issue or completely comfortable.|week 4|Analysis was on those subjects randomized to either arm with the intent to treat.||hours||Inter-Quartile Range|Median
806749|NCT01016652|Secondary|Subject Reported Lens Comfort Using CLUE Questionnaire|Subject reported lens comfort was assessed using the CLUE Questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. Scores range from 0 -120.|week 4|Analysis was on those subjects enrolled and randomized to either one of the arms with intent to treat.||units on a scale||Inter-Quartile Range|Median
806750|NCT01016652|Secondary|Proportion of Subjects With Near Vision Symptoms as Assessed by the NVQ|Proportion of subjects reporting frequent/constant near vision problem per the Near Vision Questionnaire (NVQ). The NVQ was used to assess subjects' near vision problems. Subjects graded each question using a 5-level Likert-type scale (5-levels: never, infrequent, sometimes, frequently, constantly).|week 4|The NV Questionnaire was administered to those enrolled in the study and randomized to either treatment arm.||percentage of participants|||Number
806751|NCT01016652|Primary|Monocular Amplitude of Accommodation|The amplitude of accommodation is a measure of the eyes ability to accommodate or focus on near objects. The method used was the push-up/push-down method performed monocularly. One eye was occluded and using the smallest print the subject was able to read, the reading chart was slowly moved towards the subject. The subject was asked them to indicate when the print first becomes blurred. The distance was noted and the amplitude of accommodation was calculated.|week 4|Analysis was on those who were randomized to either treatment arm with intent to treat. One eye was chosen.||diopters||Inter-Quartile Range|Median
806752|NCT01016652|Primary|Subject Reported Overall Vision Quality Using (CLUE)TM Questionnaire|The Contact Lens User Experience (CLUE) Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response, with scores ranging from 0-120.|week 4|Analysis was on those subjects enrolled, randomized into one of two randomized arms, and who completed the study.||units on a scale||Inter-Quartile Range|Median
806753|NCT01016678|Secondary|To Evaluate the Consistency of Response Across Four Migraine Attacks at 1, 2, 4, and 24 Hours After Treatment. Frequency of Rescue Medications Needed and the Consistency of Other Symptom Relief i.e. Nausea, Vomiting, Photophobia, and Phonophobia.|Collected from patient reported paper diaries|3 years|This analysis data was not collected.|||||
806764|NCT01016834|Primary|Overall Satisfaction|"Change from baseline in overall subject satisfaction with migraine treatments. Patient Perception of Migraine Questionnaire-Revised, question 3c Overall satisfaction was the measure. Baseline measured subjects satisfaction with past migraine treatments. End of study measured subject's satisfaction with migraine treatment by Sumavel DosePro. PPMQ-R scale (1-7 scale; 1=very satisfied)is transformed to a 0-100 scale (100=very satisfied)"|After 4 migraines or 60 days|The Per-protocol (PP) population included all subjects who treated at least one (and up to four) migraine episode(s) with Sumavel DosePro and complied with all other study procedures.||Scale of 0-100; 100= very satisfied||Standard Deviation|Mean
806765|NCT01016847|Secondary|Sputum Cell Counts and Differentials||Baseline/randomization to week 16|Due to insufficient accrual, data analysis was not performed.|||||
806766|NCT01016847|Secondary|Asthma Exacerbation|Asthma exacerbation is defined as the development of an increase in asthma symptoms which results in an increase in the use of asthma medications (typically inhaled corticosteroids and/or parenteral corticosteroids) or the addition of another new asthma medication or antibiotics.|Baseline/randomization to week 16|Due to insufficient accrual, data analysis was not performed.|||||
806767|NCT01016847|Secondary|Change in Trends in Asthma Control Questionnaire (ACQ ACTQ) Scores Over Duration of the Study||Baseline/randomization to week 16|Due to insufficient accrual, data analysis was not performed.|||||
806768|NCT01016847|Secondary|Post Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)||Baseline/randomization to week 16|Due to insufficient accrual, data analysis was not performed.|||||
806769|NCT01016847|Secondary|Serum Adiponectin, Leptin, Tumor Necrosis Alpha (TNF-α) and Interleukin 6 (IL6) Levels||Baseline/randomization to week 16|Due to insufficient accrual, data analysis was not performed.|||||
806770|NCT01016847|Primary|Determine the Effect of Montelukast / Moderate Dose ICS Versus High Dose ICS on Asthma Control as Measured by the Asthma Control Questionnaire.||Baseline/randomization to week 16|Due to insufficient accrual, data analysis was not performed.|||||
806771|NCT01016873|Secondary|Mean Change in Choroidal Neovascularization (CNV) as % of Lesion on Fluorescein Angiography (FA) From Baseline to Week 52||Week 52|||CNV as % of Lesion||Standard Deviation|Mean
806772|NCT01016873|Secondary|Total Number (No.) of Lucentis® Injections (Inject.) During The First 12, 28, and 104 Weeks.||Week 12, 28, and 104|||Number of Injections||Standard Deviation|Mean
806773|NCT01016873|Secondary|Time From Mandatory Injection at Day 0 to the First PRN Injection.||52 Weeks|||Weeks||95% Confidence Interval|Median
806774|NCT01016873|Secondary|Percentage (Pct.) of Patients (Pts.) Gaining ≥ 0 Letters of Best Correct Visual Acuity (BCVA) From Baseline (Base.)||Weeks 12, 28 and 52.|"Number of Participants Analyzed:
Week 12: n = 73, 71, 78
Week 28: n = 73, 73, 77
Week 52: n = 74, 72, 79"||Percentage of Patients|||Number
806775|NCT01016873|Secondary|Percentage (Pct.) of Patients (Pts.) Gaining ≥ 15 Letters of Best Correct Visual Acuity (BCVA) From Baseline (Base.)||Weeks 12, 28 and 52.|"Number of Participants Analyzed:
Week 12: n = 73, 71, 78
Week 28: n = 73, 73, 77
Week 52: n = 74, 72, 79"||Proportion of Patients|||Number
806776|NCT01016873|Secondary|Percentage (Pct.) of Patients (Pts.) Losing < 15 Letters of Best Correct Visual Acuity (BCVA) From Baseline (Base.)||Weeks 12, 28 and 52.|"Number of Participants Analyzed:
Week 12: n = 73, 71, 78
Week 28: n = 73, 73, 77
Week 52: n = 74, 72, 79"||Percentage of Patients|||Number
806777|NCT01016873|Secondary|Change in Mean Visual Acuity (VA)||Weeks 12, 28, 52 and 104.|||Letters||Standard Deviation|Mean
806778|NCT01016873|Primary|Number of Lucentis® Injections Up To And Including Week 52||During the first 52 weeks.|||Injections||Standard Deviation|Mean
806779|NCT01016912|Secondary|Percentage of Participants With Virologic Failure|Virologic failure is defined by the following 6 categories: 1.Virologic breakthrough, defined as confirmed >1 log10 increase in hepatitis C virus (HCV) RNA over nadir or confirmed HCV RNA ≥limit of quantitation (LOQ) after confirmed undetectable HCV RNA while on treatment. 2. <1 log10 decrease in HCV RNA from baseline at Week 4 of treatment. 3. Failure to achieve early virologic response, defined as <2 log10 decrease in HCV RNA from baseline at Week 12 of treatment. 4. Detectable HCV RNA at Week 12, and HCV RNA ≥LOQ at Week 24 of treatment. 5. Detectable HCV RNA at end of treatment (including early discontinuation). 6 Relapse, defined as detectable HCV RNA during follow-up after undetectable HCV RNA levels at end of treatment.|From on-treatment Week 1 to Follow-up Week 24|All participants who received at least 1 dose of study therapy.||percentage of participants|||Number
806780|NCT01016912|Secondary|Percentage of Participants With a Sustained Virologic Response (SVR) at Weeks 4, 12, and 24|SVR at follow-up Week 4 (SVR4), follow-up Week 12 (SVR12), and follow-up Week 24 (SVR24) is defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA <15 IU/mL, the lower limit of detection, target not detected) at each of these timepoints. HCV RNA levels were measured by Cobas TaqMan HCV Auto from the central laboratory .|Follow-up Weeks 4, 12, and 24|All participants who received at least 1 dose of study therapy.||percentage of participants||80% Confidence Interval|Number
806781|NCT01016912|Secondary|Percentage of Participants With Complete Early Virologic Response (cEVR)|cEVR was defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA <15 IU/mL, the lower limit of detection, target not detected) at Week 12 on treatment. HCV RNA levels were measured by Cobas TaqMan HCV Auto from the central laboratory|At Week 12 on treatment|All participants who received at least 1 dose of study therapy.||percentage of participants||80% Confidence Interval|Number
806782|NCT01016912|Secondary|Percentage of Participants With Rapid Virologic Response (RVR)|RVR was defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA <15 IU/mL, the lower limit of detection, target not detected) at Week 4. HCV RNA levels were measured by CobasTaqMan HCV Auto from the central laboratory .|At Week 4 on treatment|All participants who received at least 1 dose of study therapy.||percentage of participants||80% Confidence Interval|Number
806783|NCT01016912|Primary|Percentage of Participants With Extended Rapid Virologic Response (eRVR)|eRVR was defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA <15 IU/mL, the lower limit of detection, target not detected) at both Weeks 4 and 12. HCV RNA levels were measured by Tobas TaqMan HCV Auto from the central laboratory.|At Weeks 4 and 12 on treatment|All participants who received at least 1 dose of study therapy.||percentage of participants||80% Confidence Interval|Number
806928|NCT01017653|Secondary|Effect of Panitumumab in Combination With Irinotecan on Corticosteroid Dose|Average change in corticosteroid dose from baseline to the end of cycle 1.|Baseline and Day 29|Insufficient data to analyze the effect of the treatment regimen on corticosteroid dose. Data was not collected for this outcome.||mg|||Number
806784|NCT01016912|Other Pre-specified|Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results|Clinically significant marked abnormalities in laboratory test results graded by the Division of AIDS grading table, 2004. Hemoglobin: Grade 3= <7.0 to 8.9 g/dL, Grade 4= <7.0 g/dL. Lymphocytes: Grade 3= 350-499 cells/mm^3, Grade 4= <350 cells/mm^3. Neutrophils: Grade 3= 500-999 cells/mm^3, Grade 4= <500 cells/mm^3. White blood cells (WBC): Grade 3= 1000-1499 cells/mm^3, Grade 4= <1000 cells/mm^3. Alanine aminotransferase (ALT): Grade 3= 5.1-10*upper limit of normal (ULN), Grade 4= >10.0*ULN. Aspartate aminotransferase (AST): Grade 3= 5.1-10*ULN, Grade 4= >10.0*ULN. Total bilirubin: Grade 3= 2.6-5*ULN, Grade 4= >5.0*ULN.|From baseline to 30 days after last dose of study drug|All participants who received at least 1 dose of study therapy.||participants|||Number
806785|NCT01016912|Other Pre-specified|Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Death as Outcome|AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not has a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Treatment-related AE was defined as an AE that had certain, probable, possible, or unknown relationship to study drug.|From baseline to 30 days after last dose of study drug|All participants who received at least 1 dose of study therapy.||participants|||Number
806786|NCT01016938|Secondary|Number of Participants Whose Tumor Motion Could be Tracked Using Dynamic MRI w/ Contrast Post Radiation|The internal margin (IM) is one half of the peak-to-peak displacement amplitude on 4D-CT images.|2 years|||participants|||Number
806787|NCT01016938|Primary|Number of Participants Whose Tumor Position is Visible Within ~2mm Using Cine-MRI Scans and External Sensors|"Tumor tracking using cine-MRI and external surrogates with an accuracy of ~ 2mm.
The participants’ tumor size/margins were not specficially defined as long as it was visible/measurable on the MRI."|2 years|||participants|||Number
806788|NCT01016964|Primary|Change in Hair Count at 16 and 26 Weeks Over Baseline|The primary analysis of effectiveness was an analysis of covariance, which separately modeled terminal hair count at Week 16 and Week 26 as a function of treatment group (HairMax LaserComb 2009 9 Beam vs.control), study center, age (as a continuous variable), and Fitzpatrick Skin Type classification (as a categorical variable with four levels). The active group was compared to the control device using least squares means with a two-sided test at the 5% level of significance.|Baseline, 16 weeks, 26 weeks|||hairs per cm^2||Standard Deviation|Mean
806789|NCT01016977|Secondary|Overall Satisfaction With Study Product at Week 12|"Overall satisfaction with the study product was assessed from a participant's answer to the following question on the product acceptability and preference questionnaire at the end of study (i.e., Week 12): What is your overall satisfaction with the study product. Participants assessed overall satisfaction with the study product in the morning and evening, based on a 6-point scale: 1, very satisfied; 2, satisfied; 3, neutral (no opinion); 4, unsatisfied; 5, very unsatisfied."|Week 12|ITT Population||units on a scale||Standard Deviation|Mean
806790|NCT01016977|Secondary|Mean Change From Baseline for the Functional Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 12|Skindex-29 is a 3-component (symptomatic, emotional, and functional) self-administered questionnaire (comprised of 30 questions) used to comprehensively measure the complex effects of skin diseases on a participant's quality of life. Participants were asked to answer questions based on a 5-point scale concerning their feelings over the past 4 weeks about the skin condition that has bothered them the most: 1, never; 2, rarely; 3, sometimes; 4, often; 5, all the time. The Functional Score is the sum of 12 question scores; total score ranges from 12 to 60.|Baseline and Week 12|ITT Population. Participants with missing baseline values were not included in this analysis. No sunscreen or moisturizer data were collected; thus, there was no analysis of these data.||units on a scale||Standard Deviation|Mean
806791|NCT01016977|Secondary|Mean Change From Baseline for the Emotional Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 12|Skindex-29 is a 3-component (symptomatic, emotional, and functional) self-administered questionnaire (comprised of 30 questions) used to comprehensively measure the complex effects of skin diseases on a participant's quality of life. Participants were asked to answer questions based on a 5-point scale concerning their feelings over the past 4 weeks about the skin condition that has bothered them the most: 1, never; 2, rarely; 3, sometimes; 4, often; 5, all the time. The Emotional Score is the sum of 10 question scores; total score ranges from 10 to 50.|Baseline and Week 12|ITT Population. Participants with missing baseline values were not included in this analysis. No sunscreen or moisturizer data were collected; thus, there was no analysis of these data.||units on a scale||Standard Deviation|Mean
806792|NCT01016977|Secondary|Mean Change From Baseline for the Symptomatic Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 12|Skindex-29 is a 3-component (symptomatic, emotional, and functional) self-administered questionnaire (comprised of 30 questions) used to comprehensively measure the complex effects of skin diseases on a participant's quality of life. Participants were asked to answer questions based on a 5-point scale concerning their feelings over the past 4 weeks about the skin condition that has bothered them the most: 1, never; 2, rarely; 3, sometimes; 4, often; 5, all the time. The Symptomatic Score is the sum of 7 question scores; total score ranges from 7 to 35.|Baseline and Week 12|ITT Population. Participants with missing baseline values were not included in this analysis. No sunscreen or moisturizer data were collected; thus, there was no analysis of these data.||units on a scale||Standard Deviation|Mean
806793|NCT01016977|Secondary|Mean Change From Baseline for the Global Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 12|Skindex-29 is a 3-component (symptomatic, emotional, and functional) self-administered questionnaire (comprised of 30 questions) used to comprehensively measure the complex effects of skin diseases on a participant's quality of life. Participants were asked to answer questions based on a 5-point scale concerning their feelings over the past 4 weeks about the skin condition that has bothered them the most: 1, never; 2, rarely; 3, sometimes; 4, often; 5, all the time. The Global Score is the sum of the 30 question scores; total score ranges from 30 to 150.|Baseline and Week 12|ITT Population. Participants with missing baseline values were not included in this analysis. No sunscreen or moisturizer data were collected; thus, there was no analysis of these data.||units on a scale||Standard Deviation|Mean
806929|NCT01017653|Secondary|Safety of Panitumumab in Combination With Irinotecan|Number of participants experiencing a toxicity ≥ grade 3 as graded per CTCAE v.3.0|16 months|||participants|||Number
806794|NCT01016977|Secondary|Mean Change From Baseline in Total Lesion Count at Weeks 1, 2, 4, 8, and 12|The investigator will count inflammatory (papules, pustules, and nodules) and non-inflammatory (open and closed comedones) lesions on the participant's face at each study visit. The face is defined as the hairline edge to the mandibular line and should include the forehead, cheeks, and chin.|Baseline and Weeks 1, 2, 4, 8, and 12|ITT Population||lesions||Standard Deviation|Mean
806795|NCT01016977|Secondary|Mean Change From Baseline in Inflammatory and Non-inflammatory Lesion Counts at Weeks 1, 2, 4, 8, and 12|Inflammation is defined as a localized protective reaction of tissue to irritation, injury, or infection, characterized by pain, redness, swelling, and sometimes loss of function. The investigator counted inflammatory (papules, pustules, and nodules) and non-inflammatory (open and closed comedones) lesions on a participant's face at each study visit. The face is defined as the hairline edge to the mandibular line and should include the forehead, cheeks, and chin. W, Week.|Baseline and Weeks 1, 2, 4, 8, and 12|ITT Population||lesions||Standard Deviation|Mean
806796|NCT01016977|Secondary|Number of Participants With at Least a Two-grade Improvement in ISGA Score From Baseline to Week 12|The investigator conducted the overall assessment of the participant’s facial acne vulgaris based on the Investigator's Static Global Assessment Scale (ISGA). The ISGA is a 6-point scale: 0, clear skin with no acne vulgaris; 1, almost clear skin; 2, mild; 3, moderate; 4, severe; 5, very severe.|Baseline and Week 12|ITT Population||participants|||Number
806797|NCT01016977|Primary|Mean Change From Baseline in Skin Overall Comfort at Weeks 1, 2, 4, 8, and 12|Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 8, and 12 minus the value at baseline. Skin comfort was assessed by participants based on 5-point scale: +2, very comfortable; +1, comfortable; 0, neutral; -1, somewhat uncomfortable; or -2, uncomfortable.|Baseline and Weeks 1, 2, 4, 8, and 12|ITT Population. Some participants did not return for all visits; thus, data were not captured for all participants in the ITT Population at all visits.||units on a scale||Standard Deviation|Mean
806798|NCT01016977|Primary|Mean Change From Baseline in Oiliness at Weeks 1, 2, 4, 8, and 12|Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 8, and 12 minus the value at baseline. Oiliness was assessed by participants based on a 6-point scale: 0=none: normal, no discomfort; 1=trace: awareness, no discomfort, no intervention required; 2=mild: noticeable discomfort, intermittent awareness; 3=moderate: noticeable discomfort, continuous awareness; 4=marked: definite discomfort, continuous awareness, interferes occasionally with normal daily activities; 5=severe: definite continuous discomfort, interferes with normal daily activities.|Baseline and Weeks 1, 2, 4, 8, and 12|ITT Population. Some participants did not return for all visits; thus, data were not captured for all participants in the ITT Population at all visits.||units on a scale||Standard Deviation|Mean
806799|NCT01016977|Primary|Mean Change From Baseline in Itching at Weeks 1, 2, 4, 8, and 12|Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 6, 8, and 12 minus the value at baseline. Itching was assessed by participants based on a 6-point scale: 0=none: normal, no discomfort; 1=trace: awareness, no discomfort, no intervention required; 2=mild: noticeable discomfort, intermittent awareness; 3=moderate: noticeable discomfort, continuous awareness; 4=marked: definite discomfort, continuous awareness, interferes occasionally with normal daily activities; 5=severe: definite continuous discomfort, interferes with normal daily activities.|Baseline and Weeks 1, 2, 4, 8, and 12|ITT Population. Some participants did not return for all visits; thus, data were not captured for all participants in the ITT Population at all visits.||units on a scale||Standard Deviation|Mean
806800|NCT01016977|Primary|Mean Change From Baseline in Burning/Stinging at Weeks 1, 2, 4, 8, and 12|Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 8, and 12 minus the value at baseline. Burning/stinging was assessed by participants based on a 6-point scale: 0=none: normal, no discomfort; 1=trace: awareness, no discomfort, no intervention required; 2=mild: noticeable discomfort, intermittent awareness; 3=moderate: noticeable discomfort, continuous awareness; 4=marked: definite discomfort, continuous awareness, interferes occasionally with normal daily activities; 5=severe: definite continuous discomfort, interferes with normal daily activities.|Baseline and Weeks 1, 2, 4, 8, and 12|ITT Population. Some participants did not return for all visits; thus, data were not captured for all participants in the ITT Population at all visits.||units on a scale||Standard Deviation|Mean
806801|NCT01016977|Primary|Mean Change From Baseline in Peeling at Weeks 1, 2, 4, 8, and 12|Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 8, and 12 minus the value at baseline. Peeling was assessed by the investigator based on a 6-point scale: 0=none, which is normal; 1=trace, which is mild and localized; 2=mild, which is mild and diffuse; 3=moderate, which is moderate and diffuse; 4=marked, which is moderate and dense; 5=severe, which is prominent and dense.|Baseline and Weeks 1, 2, 4, 8, and 12|ITT Population. Some participants did not return for all visits; thus, data were not captured for all participants in the ITT Population at all visits.||units on a scale||Standard Deviation|Mean
806802|NCT01016977|Primary|Mean Change From Baseline in Dryness at Weeks 1, 2, 4, 8, and 12|Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 8, and 12 minus the value at baseline. Dryness was assessed by the investigator based on a 6-point scale: 0=none, which is normal; 1=trace, which is mild and localized; 2=mild, which is mild and diffuse; 3=moderate, which is moderate and diffuse; 4=marked, which is moderate and dense; 5=severe, which is prominent and dense.|Baseline and Weeks 1, 2, 4, 8, and 12|ITT Population. Some participants did not return for all visits; thus, data were not captured for all participants in the ITT Population at all visits.||units on a scale||Standard Deviation|Mean
806803|NCT01016977|Primary|Mean Change From Baseline in Erythema at Weeks 1, 2, 4, 8, and 12|Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 8, and 12 minus the value at baseline. Erythema (redness of the skin, due to increased blood flow in the capillaries in the lower layers of theh skin) was assessed by the investigator based on a 6-point scale: 0=none, which is normal; 1=trace, which is mild and localized; 2=mild, which is mild and diffuse; 3=moderate, which is moderate and diffuse; 4=marked, which is moderate and dense; 5=severe, which is prominent and dense.|Baseline and Weeks 1, 2, 4, 8, and 12|Intent-to-Treat (ITT) Population: all randomized participants who received study product. Some participants did not return for all visits; thus, data were not captured for all participants in the ITT Population at all visits.||units on a scale||Standard Deviation|Mean
806930|NCT01017653|Secondary|One-Year Overall Survival|Percentage of participants surviving 12 months from the start of study treatment. OS was defined as the time from the date of study treatment initiation to the date of the death due to any cause.|1 year|||percentage of participants||95% Confidence Interval|Number
806804|NCT01017003|Primary|Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC 0-inf)|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|0.0, 0.5, 1,1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing|by protocol||pg-h/ml||Standard Deviation|Mean
806805|NCT01017003|Primary|Area Under the Concentration Versus Time Curve From Time Zero to the Time of the Last Measured Level.|Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (t), calculated using the linear trapezoidal rule.|0.0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 36, 48, 72, and 96 hours after dosing|by protocol||pg-h/ml||Standard Deviation|Mean
806806|NCT01017003|Primary|Maximum Serum Concentration (Cmax)|maximum serum concentration measured after a single oral dose in fasted healthy adults and after a single oral dose in fasted healthy adults at steady state for comparison of the two conditions|Pharmacokinetic samples collected pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing|per protocol||pg/mL||Standard Deviation|Mean
806807|NCT01017029|Secondary|Participants With at Least One Occurrence of Composite Treatment Failure Events|Comparison of 6-months cumulative incidence of composite treatment failure events (BPAR ≥ 2R, rejection with hemodynamic compromise, graft loss, or death) between delayed everolimus arm and immediate everolimus arm|6 months|||participants||95% Confidence Interval|Number
806808|NCT01017029|Secondary|Participants With CMV Infection and CMV Syndrome/Disease After 6 Months by Treatment Group|CMV infection is defined as pp65 antigenemia or DNAemia|6 months|safety population||participants||95% Confidence Interval|Number
806809|NCT01017029|Secondary|Absolute and Percent Frequencies of Patients With LDL ≥ 100 mg/mL at 1, 3 and 6 Months, by Treatment Group|LDL = low density lipoprotein|6 months|safety population||participants||95% Confidence Interval|Number
806810|NCT01017029|Secondary|Hazard Cox’s Model Analysis of Pericardial/Pleural Effusions|Pericardial effusions: any pericardial effusion defined as at least moderate (i.e. measuring at least 2.0 cm in diastole, in the point of largest distance between the pericardial leaflets), with or without signs of hemodynamic compromise, or leading to drainage or to prolonged hospitalization. Pleural effusions: need for surgical drainage tubes for longer than 7 days after surgery and subsequent pleural effusions leading to drainage. CI = confidence interval, HR = hazard ratio, MDRD = Modification of Diet in Renal Disease|6 months|safety population||participants|||Number
806811|NCT01017029|Secondary|Partcipants With at Least One Occurrence of Each Safety Composite Endpoint Event After 6 Months by Treatment Group||6 months|safety population||participants|Participants|95% Confidence Interval|Number
806812|NCT01017029|Primary|Participants With at Least One Occurrence of Safety Composite Endpoint After 6 Months by Treatment Group|Comparison of 6-month cumulative incidence of safety composite endpoint (wound healing delay) related to initial transplant surgery, pleural/pericardial effusions and occurrence of acute renal insufficiency, defined as estimated glomerular filtration rate (eGFR) ≤ 30 mL/min/1.73 m2, between delayed everolimus arm and immediate everolimus arm|6 months|safety population||participants||95% Confidence Interval|Number
806813|NCT01017042|Primary|Area Under The Concentration Time Curve From Zero Through Infinity (AUC∞)|"The area under the plasma concentration versus time curve extrapolated to infinity.
AUC∞ is calculated as the sum of Total AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant"|Pharmacokinetic samples collected pre-dose and 0.5, 1 hour (prior to the second dose), and 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, 24, 36, and 48 hours post-dose (relative to the first dose) and 72 and 96 hours post-dose (on an outpatient basis).|||pg-hr/ml||Standard Deviation|Mean
806814|NCT01017042|Primary|Area Under the Concentration Time Curve From Time Zero to the Time of Last Measured Concentration (96 Hours) (AUC 0-t)|The area under the plasma concentration versus time curve beginning from the first dose until the last quantifiable concentration (96hours), calculated by the linear trapezoidal rule.|Pharmacokinetic samples collected pre-dose and 0.5, 1 hour (prior to the second dose), and 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, 24, 36, and 48 hours post-dose (relative to the first dose) and 72 and 96 hours post-dose (on an outpatient basis).|||pg-hr/ml||Standard Deviation|Mean
806815|NCT01017042|Secondary|Electrocardiogram Corrected QT Interval (QTcF)|Corrected QT interval by Fridericia’s formula -Measured at baseline, 0.5, 1, 2, and 4 hours|Measured at baseline, 0.5, 1, 2, and 4 hours|All participants||Milliseconds||Standard Deviation|Mean
806816|NCT01017042|Primary|Maximum Plasma Concentration|The maximum or peak concentration that the drug reaches in the plasma.|Pharmacokinetic samples collected pre-dose and 0.5, 1 hour (prior to the second dose), and 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, 24, 36, and 48 hours post-dose (relative to the first dose) and 72 and 96 hours post-dose (on an outpatient basis).|||picograms/ml||Standard Deviation|Mean
806817|NCT01017120|Secondary|Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants|Burning/stinging is a pain and burning sensation. Local tolerability assessments were performed by the participant at each study visit based on severity as G0 to G3: G0=none; G1=slight; G2=moderate; G3=strong. Maximum During Treatment is defined as the maximum severity of burning/stinging reported at any time during treatment.|Baseline (Week 0/Day 1) to Week 12|All Randomized Participants||participants|||Number
806818|NCT01017120|Secondary|Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants|Itching is a sensation that causes the desire or reflex to scratch. Local tolerability assessments for itching were performed by the participant at each study visit and were graded based on severity as G0 to G3. G0=none; G1=slight; G2=moderate; G3=strong. Maximum During Treatment is defined as the maximum severity of itching reported at any time during treatment.|Baseline (Week 0/Day 1) to Week 12|All Randomized Participants||participants|||Number
806819|NCT01017120|Secondary|Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator|Peeling skin: damage to and loss of the upper layer of skin (epidermis). Local tolerability assessments for peeling were performed by the Investigator at each study visit and were graded based on severity as G0 to G4: G0=absent (no peeling); G1=slight (mild localized peeling); G2=mild (mild and diffuse peeling); G3=moderate (moderate and diffuse peeling); G4=severe (moderate to prominent, dense peeling). Maximum During Treatment is defined as the maximum severity of peeling reported at any time during treatment.|Baseline (Week 0/Day 1) to Week 12|All Randomized Participants||participants|||Number
806820|NCT01017120|Secondary|Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator|Dryness=skin epidermis that lacks moisture/sebum. Local tolerability assessments were performed by the Investigator at each study visit and were graded based on severity as G0 to G4. G0=absent (none); G1=slight (barely perceptible dryness with no flakes or fissure formation); G2=mild (easily perceptible dryness with no flakes or fissure formation); G3=moderate (easily noted dryness and flakes but no fissure formation); G4=severe (easily noted dryness with flakes and fissure formation). Maximum During Treatment is defined as the maximum severity of dryness reported at any time during treatment.|Baseline (Week 0/Day 1) to Week 12|All Randomized Participants||participants|||Number
806821|NCT01017120|Secondary|Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator|Erythema is a skin condition characterized by redness or rash. Local tolerability assessments were performed by the Investigator at each study visit and were graded based on severity as G0 to G4: G0=absent (no redness); G1=slight (faint red or pink coloration, barely perceptible); G2=mild (light red or pink coloration); G3=moderate (medium red coloration); G4=severe (beet red coloration). Maximum During Treatment is defined as the maximum severity of erythema reported at any time during treatment.|Baseline (Week 0/Day 1) to Week 12|All Randomized Participants: all participants who were randomized in the study||participants|||Number
806822|NCT01017120|Secondary|Change in Children’s Dermatology Life Quality Index (CDLQI) From Baseline at Week 2, 4, 8 and 12 in Participant's With 16 Years Old or Younger|The CDLQI was used to measure how much the participants’ skin problem had affected their life over the last week. The CDLQI total score ranges from 0 to 30: 0-1=no effect at all on the participant’s life; 2-6=small effect on the participant’s life; 7-12=moderate effect on the participant’s life; 13-18=very large effect on the participant’s life; 19-30=extremely large effect on the participant’s life. A lower score on the CDLQI indicates increased quality of life; therefore, negative changes from Baseline indicate improvements.|Baseline (Week 0/Day 1); Week 2, 4, 8, and 12|ITT Analysis Set: only those participants 16 years of age or younger and whose CDLQI scores were calculated at Baseline and at Weeks 2, 4, 8, or 12 were evaluated for change in DLQI score at respective week.||scores on a scale||Standard Deviation|Mean
806823|NCT01017120|Secondary|Change in Dermatology Life Quality Index (DLQI) Score From Baseline at Weeks 2, 4, 8, and 12 in Participants 17 Years of Age or Older|The DLQI was used to measure how much the participants’ skin problem had affected their life over the last week. The DLQI total score ranges from 0 to 30: 0-1=no effect at all on the participant’s life; 2-5=small effect on the participant’s life; 6-10=moderate effect on the participant’s life; 11-20=very large effect on the participant’s life; 21-30=extremely large effect on the participant’s life. A lower score on the DLQI indicates increased quality of life; therefore, negative changes from Baseline indicate improvements.|Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12|ITT Analysis Set: only those participants 17 years of age or older and whose DLQI scores were calculated at baseline and at Weeks 2, 4, 8, or 12 were evaluated for change in DLQI score at respective week.||scores on a scale||Standard Deviation|Mean
806824|NCT01017120|Secondary|Absolute Change in Closed Comedone Count From Baseline at Weeks 2, 4, 8, and 12|A closed comedone is a whitehead. Change from basline in closed comedone count at Weeks 2, 4, 8, and 12 was calculated as the closed comedone count at Week 2/4/8/12 minus the closed comedone count at Baseline.|Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12|ITT Analysis Set||closed comedone count||Standard Deviation|Mean
806825|NCT01017120|Secondary|Absolute Change in Open Comedone Count From Baseline at Weeks 2, 4, 8, and 12|An open comedone is a yellow or blackish bump or plug on the skin. Change from Baseline in open comedone count at Weeks 2, 4, 8, and 12 was calculated as the open comedone count at Week 2/4/8/12 minus the open comedone count at Baseline.|Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12|ITT Analysis Set||open comedone count||Standard Deviation|Mean
806826|NCT01017120|Secondary|Absolute Change in Nodule Count From Baseline at Weeks 2, 4, 8, and 12|A nodule is a slightly elevated lesion on or in the skin. Change from basline in nodule count at Weeks 2, 4, 8, and 12 was calculated as the nodule count at Week 2/4/8/12 value (s) minus the nodule count at Baseline.|Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12|ITT Analysis Set||nodule count||Standard Deviation|Mean
806827|NCT01017120|Secondary|Absolute Change in Pustule Count From Baseline at Weeks 2, 4, 8, and 12|A pustule is a small elevation of the skin containing cloudy or purulent material usually consisting of necrotic inflammatory cells. Change from basline in pustule count at Weeks 2, 4, 8, and 12 was calculated as the pustule count at Week 2/4/8/12 minus the pustule count at Baseline.|Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12|ITT Analysis Set||pustule count||Standard Deviation|Mean
806828|NCT01017120|Secondary|Absolute Change in Papule Count From Baseline at Weeks 2, 4, 8, and 12|A papule is a circumscribed, solid elevation of the skin with no visible fluid. Change from basline in papule count at Weeks 2, 4, 8, and 12 was calculated as the papule count at Week 2/4/8/12 minus the papule count at Baseline.|Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12|ITT Analysis Set||papule count||Standard Deviation|Mean
806829|NCT01017120|Secondary|Number of Participants With a 2-G Improvement in ISGA Score and an ISGA Score of 0 or 1 at Weeks 2, 4, 8, and 12|Investigators evaluated the acne severity (S) of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than rare papules; 2=mild S: >G 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate S: >G 2, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: greater than G 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe: many NILs and ILs and more than a few NLs, may have cystic lesions.|Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12|ITT Analysis Set||participants|||Number
806830|NCT01017120|Secondary|Number of Participants With a Subject’s Global Assessment (SGA) Score of 0 or 1 at Weeks 2, 4, 8, and 12|An SGA of the facial skin, excluding the scalp, was performed by participants using a rating scale of 0 to 4: 0=face is basically free of acne, with only an occasional blackhead (Bh) and/or whitehead (Wh); 1=face has several Bhs and/or Whs and small pimples (P), but there are no tender deep-seated bumps or cysts (DSBCs); 2=face has several to many Bhs and/or Whs and small- to medium-sized P, and may have one DSBC; 3=face has many Bhs and/or Whs, many medium- to large-sized P, and perhaps a few DSBCs; 4=face has Bhs and/or Whs, and several to many medium- to large-sized Ps and DSBCs dominate.|Weeks 2, 4, 8, and 12|ITT Analysis Set||participants|||Number
810310|NCT01050764|Secondary|Median Overall Survival (OS)|Reported as the median overall survival (OS) in months from infusion of the hematopoietic stem cells (HSCT)|25 months|Population of participants that received HSCT and T-reg plus T-con||months||Standard Deviation|Median
806831|NCT01017120|Secondary|Number of Participants With an ISGA Score of 0 or 1 at Weeks 2, 4, and 8|Investigators evaluated the acne severity (S) of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than rare papules; 2=mild S: >G 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate S: >G 2, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: greater than G 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe: many NILs and ILs and more than a few NLs, may have cystic lesions.|Weeks 2, 4, and 8|ITT Analysis Set. Missing values were imputed using the LOCF method.||participants|||Number
806832|NCT01017120|Secondary|Number of Participants With a Minimum 2 G Improvement in ISGA Score at Weeks 2, 4, and 8|Investigators evaluated the acne severity (S) of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than rare papules; 2=mild S: >G 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate S: >G 2, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: greater than G 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe: many NILs and ILs and more than a few NLs, may have cystic lesions.|Baseline (Week 0/Day 1); Weeks 2, 4, and 8|ITT Analysis Set||participants|||Number
806833|NCT01017120|Secondary|Time to a 50 Percent Reduction in Total Lesion Counts (TLC)|Time to a 50 percent reduction in TLC (sum of ILs and NILs) was the time difference between Baseline and the time to 50 percent reduction in LC. Participants who did not have a >=50 percent reduction from Baseline in TLC during the study were censored at their last visit date.|Baseline (Week 0/Day 1) to Week 12|ITT Analysis Set: only those participants with a >=50 percent reduction from Baseline in TLC were evaluated.||days||95% Confidence Interval|Median
806834|NCT01017120|Secondary|Absolute Change From Baseline in LC at Weeks 2, 4, and 8|LC: count of all ILs (i.e., papules, pustules, and nodules) and NILs (i.e., open and closed comedones) at Baseline and at Week 12. TLs were calculated as the sum of ILs and NILs. LC was confined to the face (including forehead, nose, checks, and chin). Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline. Calculation was based on last observation carried forward (LOCF) imputation method for missing data.|Baseline (Week 0/Day 1); Weeks 2, 4, and 8|ITT Analysis Set. Calculation was based on the LOCF imputation method for missing data.||lesion counts||Standard Deviation|Mean
806835|NCT01017120|Secondary|Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12|LC: count of all ILs (i.e., papules, pustules, and nodules) and NILs (i.e., open and closed comedones) at Baseline and at Week 12. TLs were calculated as the sum of ILs and NILs. LC was confined to the face (including forehead, nose, checks, and chin). Percent change from Baseline in LC at Weeks 2, 4, 8, and12 was calculated as the (Week 2/4/8/12 value minus the baseline value divided by baseline value) x 100.|Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12|ITT Analysis Set. The LOCF imputation method was used for missing data.||percentage change||Standard Deviation|Mean
806836|NCT01017120|Primary|Number of Participants With an ISGA Score of 0 or 1 at Week 12|Investigators evaluated the acne severity (S) of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than rare papules; 2=mild S: >G 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate S: >G 2, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: greater than G 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe: many NILs and ILs and more than a few NLs, may have cystic lesions.|Week 12|ITT Analysis Set. Missing values were imputed using the LOCF method.||participants|||Number
806837|NCT01017120|Primary|Number of Participants With a Minimum 2-grade (G) Improvement in the Investigator Static Global Assessment (ISGA) Score From Baseline at Week 12|Investigators evaluated the acne severity (S) of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than rare papules; 2=mild S: >G 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate S: >G 2, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: greater than G 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe: many NILs and ILs and more than a few NLs, may have cystic lesions.|Baseline (Week 0/Day 1) and Week 12|ITT Analysis Set||participants|||Number
806838|NCT01017120|Primary|Absolute Change in Lesion Counts (LCs) From Baseline to Week 12|LC: count of all inflammatory lesions (ILs, i.e., papules, pustules, and nodules) and non-inflammatory lesions (NILs, i.e., open and closed comedones) at Baseline and at Week 12. Total lesions (TLs) were calculated as the sum of ILs and NILs. LC was confined to the face (including forehead, nose, checks, and chin). Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline.|Baseline (Week 0/Day 1) and Week 12|Intent-to-Treat (ITT) Analysis Set: all randomized participants who were dispensed study product. Calculation was based on the last observation carried forward (LOCF) imputation method for missing data, in which missing final values of the outcome variable are replaced by the last known value before the participant was lost to follow up.||lesion counts||Standard Deviation|Mean
806839|NCT01017146|Secondary|Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants|Burning/stinging is a pain and burning sensation. Local tolerability assessments were performed by the participant at each study visit based on severity as G0 to G3: G0=none; G1=slight; G2=moderate; G3=strong. Maximum During Treatment is defined as the maximum severity of burning/stinging reported at any time during treatment.|Baseline (Week 0/Day 1) to Week 12|All Randomized Participants||participants|||Number
806840|NCT01017146|Secondary|Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants|Itching is a sensation that causes the desire or reflex to scratch. Local tolerability assessments for itching were performed by the participant at each study visit and were graded based on severity as G0 to G3. G0=none; G1=slight; G2=moderate; G3=strong. Maximum During Treatment is defined as the maximum severity of itching reported at any time during treatment.|Baseline (Week 0/Day 1) to Week 12|All Randomized Participants||participants|||Number
806878|NCT01017237|Primary|Amnesia: Lack of Picture Recall Shown Prior to Sedation.|Subjects were shown pictures of familiar objects prior to sedation, after the bolus dose of dexmedetomidine was administered, at 15 minutes and 30 minutes into the surgery and at the end of surgery. Subjects were shown a page containing multiple pictures to evaluate whether they could remember any of them. No recall demonstrating the presence of amnesia during that portion of the procedure. This process was repeated the day following surgery|Day of surgery prior to discharge|Randomized per protocol||percentage of participants|||Number
806841|NCT01017146|Secondary|Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator|Peeling skin: damage to and loss of the upper layer of skin (epidermis). Local tolerability assessments for peeling were performed by the Investigator at each study visit and were graded based on severity as G0 to G4: G0=absent (no peeling); G1=slight (mild localized peeling); G2=mild (mild and diffuse peeling); G3=moderate (moderate and diffuse peeling); G4=severe (moderate to prominent, dense peeling). Maximum During Treatment is defined as the maximum severity of peeling reported at any time during treatment.|Baseline (Week 0/Day 1) to Week 12|All Randomized Participants||participants|||Number
806842|NCT01017146|Secondary|Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator|Dryness: skin epidermis that lacks moisture/sebum. Local tolerability assessments were performed by the Investigator at each study visit and were graded based on severity as G0 to G4. G0=absent (none); G1=slight (barely perceptible dryness with no flakes or fissure formation); G2=mild (easily perceptible dryness with no flakes or fissure formation); G3=moderate (easily noted dryness and flakes but no fissure formation); G4=severe (easily noted dryness with flakes and fissure formation). Maximum During Treatment is defined as the maximum severity of drying reported at any time during treatment.|Baseline (Week 0/Day 1) to Week 12|All Randomized Participants||participants|||Number
806843|NCT01017146|Secondary|Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator|Erythema is a skin condition characterized by redness or rash. Local tolerability assessments were performed by the Investigator at each study visit and were graded based on severity as G0 to G4: G0=absent (no redness); G1=slight (faint red or pink coloration, barely perceptible); G2=mild (light red or pink coloration); G3=moderate (medium red coloration); G4=severe (beet red coloration). Maximum During Treatment is defined as the maximum severity of erythema reported at any time during treatment.|Baseline (Week 0/Day 1) to Week 12|All Randomized Participants: all participants who were randomized in the study||participants|||Number
806844|NCT01017146|Secondary|Change in Children’s Dermatology Life Quality Index (CDLQI) From Baseline at Week 2, 4, 8 and 12 in Participant's With 16 Years Old or Younger|The CDLQI was used to measure how much the participants’ skin problem had affected their life over the last week. The CDLQI total score ranges from 0 to 30: 0-1=no effect at all on the participant’s life; 2-6=small effect on the participant’s life; 7-12=moderate effect on the participant’s life; 13-18=very large effect on the participant’s life; 19-30=extremely large effect on the participant’s life. A lower score on the CDLQI indicates increased quality of life; therefore, negative changes from Baseline indicate improvements.|Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12|ITT Analysis Set: only those participants 16 years of age or younger and whose CDLQI scores were calculated at Baseline and at Weeks 2, 4, 8, or 12 were evaluated for change in DLQI score at the respective week.||scores on a scale||Standard Deviation|Mean
806845|NCT01017146|Secondary|Change in Dermatology Life Quality Index (DLQI) Score From Baseline at Weeks 2, 4, 8, and 12 in Participants 17 Years of Age or Older|The DLQI was used to measure how much the participants’ skin problem had affected their life over the last week. The DLQI total score ranges from 0 to 30: 0-1=no effect at all on the participant’s life; 2-5=small effect on the participant’s life; 6-10=moderate effect on the participant’s life; 11-20=very large effect on the participant’s life; 21-30=extremely large effect on the participant’s life. A lower score on the DLQI indicates increased quality of life; therefore, negative changes from Baseline indicate improvements.|Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12|ITT Analysis Set: only those participants 17 years of age or older and whose DLQI scores were calculated at Baseline and at Weeks 2, 4, 8, or 12 were evaluated for change in DLQI score at the respective week.||Scores on a scale||Standard Deviation|Mean
806846|NCT01017146|Secondary|Number of Participants With a Subject’s Global Assessment (SGA) Score of 0 or 1 at Weeks 2, 4, 8, and 12|An SGA of the facial skin, excluding the scalp, was performed by participants using a rating scale of 0 to 4: 0=face is basically free of acne, with only an occasional blackhead (Bh) and/or whitehead (Wh); 1=face has several Bhs and/or Whs and small pimples (P), but there are no tender deep-seated bumps or cysts (DSBCs); 2=face has several to many Bhs and/or Whs and small- to medium-sized P, and may have one DSBC; 3=face has many Bhs and/or Whs, many medium- to large-sized P, and perhaps a few DSBCs; 4=face has Bhs and/or Whs, and several to many medium- to large-sized Ps and DSBCs dominate.|Weeks 2, 4, 8, and 12|ITT Analysis Set||participants|||Number
806847|NCT01017146|Secondary|Number of Participants With an ISGA Score of 0 or 1 at Weeks 2, 4, and 8|Investigators evaluated the acne severity (S) of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than rare papules; 2=mild S: >G 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate S: >G 2, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: greater than G 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe: many NILs and ILs and more than a few NLs, may have cystic lesions.|Weeks 2, 4, and 8|ITT Analysis Set. Missing values were imputed using the LOCF method.||participants|||Number
806848|NCT01017146|Secondary|Number of Participants With a Minimum 2-grade Improvement in ISGA Score at Weeks 2, 4, and 8|Investigators evaluated the acne severity (S) of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than rare papules; 2=mild S: >G 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate S: >G 2, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: greater than G 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe: many NILs and ILs and more than a few NLs, may have cystic lesions.|Baseline (Week 0/Day 1); Weeks 2, 4, and 8|ITT Analysis Set||participants|||Number
806849|NCT01017146|Secondary|Time to a 50 Percent Reduction in Total Lesion Counts (TLC)|Time to a 50 percent reduction in TLC (sum of ILs and NILs) was the time difference between Baseline and the time to 50 percent reduction in LC. Participants who did not have a >=50 percent reduction from Baseline in TLC during the study were censored at their last visit date.|Baseline (Week 0/Day 1) to Week 12|ITT Analysis Set: only those participants with a >=50 percent reduction from Baseline in TLC were evaluated.||days||95% Confidence Interval|Median
806901|NCT01017497|Secondary|Median Overall Survival|Overall survival was defined as the time in months from the start of SRS to the date of death or last contact if alive. Kaplan-Meier methods were used to estimate overall survival.|24 months after SRS|||months||95% Confidence Interval|Median
820567|NCT01145755|Secondary|MADRS Response|A MADRS responder at week 6 is defined as a patient with a reduction of at least 50% from baseline MADRS total score.|6 weeks|||Participants|||Number
806850|NCT01017146|Secondary|Absolute Change From Baseline in LC at Weeks 2, 4, and 8|LC: count of all ILs (i.e., papules, pustules, and nodules) and NILs (i.e., open and closed comedones) at Baseline and at Week 12. TLs were calculated as the sum of ILs and NILs. LC was confined to the face (including forehead, nose, checks, and chin). Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at baseline. Calculation was based on last observation carried forward (LOCF) imputation method for missing data.|Baseline (Week 0/Day 1); Weeks 2, 4, and 8|ITT Analysis Set. Calculation was based on the LOCF imputation method for missing data.||lesion counts||Standard Deviation|Mean
806851|NCT01017146|Secondary|Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12|LC: count of all ILs (i.e., papules, pustules, and nodules) and NILs (i.e., open and closed comedones) at Baseline and at Week 12. TLs were calculated as the sum of ILs and NILs. LC was confined to the face (including forehead, nose, checks, and chin). Percent change from Baseline in LC at Weeks 2, 4, 8, and12 was calculated as the (Week 2/4/8/12 value minus the baseline value divided by baseline value) x 100.|Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12|ITT Analysis Set. The LOCF imputation method was used for missing data.||percent change||Standard Deviation|Mean
806852|NCT01017146|Primary|Number of Participants With an ISGA Score of 0 or 1 at Week 12|Investigators evaluated the acne severity (S) of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than rare papules; 2=mild S: >G 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate S: >G 2, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: greater than G 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe: many NILs and ILs and more than a few NLs, may have cystic lesions.|Week 12|ITT Analysis Set. Missing values were imputed using the LOCF method.||participants|||Number
806853|NCT01017146|Primary|Number of Participants With a Minimum 2-grade (G) Improvement in the Investigator Static Global Assessment (ISGA) Score From Baseline at Week 12|Investigators evaluated the acne severity (S) of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than rare papules; 2=mild S: >G 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate S: >G 2, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: greater than G 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe: many NILs and ILs and more than a few NLs, may have cystic lesions.|Baseline (Week 0/Day 1) and Week 12|ITT Analysis Set||participants|||Number
806854|NCT01017146|Primary|Absolute Change in Lesion Counts (LCs) From Baseline to Week 12|LC: count of all inflammatory lesions (ILs, i.e., papules, pustules, and nodules) and non-inflammatory lesions (NILs, i.e., open and closed comedones) at Baseline and at Week 12. Total lesions (TLs) were calculated as the sum of ILs and NILs. LC was confined to the face (including forehead, nose, checks, and chin). Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline.|Baseline (Week 0/Day 1) and Week 12|Intent-to-Treat (ITT) Analysis Set: all randomized participants who were dispensed study product. Calculation was based on the last observation carried forward (LOCF) imputation method for missing data, in which missing final values of the outcome variable are replaced by the last known value before the participant was lost to follow up.||lesion counts||Standard Deviation|Mean
806855|NCT01017237|Secondary|Bispectral Index Score (BIS)|Bispectral Index (BIS) measures level of consciousness by algorithmic analysis of the patient's electroencephalogram (EEG) during anesthesia and sedation. The BIS can range from 0 (equivalent to EEG silence) to 100 (equivalent to fully awake and alert). A BIS value of 40-60 indicates an adequate general anesthesia state.|During surgery duration.|per protocol||units on a scale||Standard Deviation|Mean
806856|NCT01017237|Secondary|Ramsey Sedation Scale Score|Rating of depth of sedation by sedationist. Scale 1 - 6, 1 being widw awake and 6 being non-responsive|During surgical procedure|per protocol||units on a scale||Standard Deviation|Mean
806857|NCT01017237|Secondary|Patient Satisfaction With Sedation Technique|Rating of how satisfied the patient was with their sedation on a scale of 1-5 with 1 being very dissatisfied and 5 being extremely satisfied|after completion of surgery (within 15 minutes)|per protocol||units on a scale||Standard Deviation|Mean
806858|NCT01017237|Secondary|Surgeon Satisfaction With Sedation Technique|Numerical value on scale of 1-5 from Very dissatisfied (1) to Extremely satisfied (5)|After surgery completed: day of surgery, within 15 minutes|per protocol||units on a scale||Standard Deviation|Mean
806859|NCT01017237|Secondary|Heart Rate|Per EKG monitor|Duration of surgery|per protocol||Beats per minute||Standard Deviation|Mean
806860|NCT01017237|Secondary|Heart Rate|Heart rate per EKG monitor|Prior to sedation|per protocol||Beats per minute||Standard Deviation|Mean
806861|NCT01017237|Secondary|Mean Arterial Blood Pressure|Measured using automated blood pressure monitor|During duration of surgery|per protocol||mmHg||Standard Deviation|Mean
806862|NCT01017237|Secondary|Mean Arterial Blood Pressure|Blood pressure per automated monitor|Immediately prior to surgery|per protocol||mmHg||Standard Deviation|Mean
806863|NCT01017237|Secondary|Respiratory Parameters: End-tidal Carbon Dioxide|Measured by capnography at nares|Duration of surgery|per protocol||mmHg||Standard Deviation|Mean
806864|NCT01017237|Secondary|Respiratory Parameters: End-tidal Carbon Dioxide|Measured via capnography at nares|Immediately prior to sedation|per protocol||mmHg||Standard Deviation|Mean
806865|NCT01017237|Primary|Amnesia: Lack of Recall One Day After Surgery of The Picture That Was Shown at Surgery End Time.|Lack of recall of picture shown indicates presence of amnesia on day following surgery.|One day after surgery|per protocol||percentage of patients|||Number
806866|NCT01017237|Primary|Amnesia: Lack of Picture Recall at Surgery End Time.|Lack of recall of picture shown indicates presence of amnesia|Day of surgery prior to discharge|per protocol||percentage of patients|||Number
806867|NCT01017237|Primary|Primary Title: Amnesia: Lack of Recall One Day After Surgery of The Picture That Was Shown 30 Minutes Into Surgery.|Lack of recall of picture shown indicates presence of amnesia on day following surgery.|One day after surgery|Per protocol||percentage of patients|||Number
806868|NCT01017237|Primary|Amnesia: Lack of Picture Recall Shown 30 Minutes Into Surgery|Lack of recall of picture shown indicates presence of amnesia|Day of Surgery prior to discharge|per protocol||percentage of patients|||Number
806869|NCT01017237|Primary|Amnesia: Lack of Recall One Day After Surgery of The Picture That Was Shown 15 Minutes Into Surgery.|Lack of recall of picture demonstrates presence of amnesia on day following surgery|One day after surgery|per protocol||percentage of patients|||Number
806879|NCT01017250|Secondary|Dynamic Contrasted-enhanced MRI (DCE-MRI) Perfusion Indices at 2 Months After Stereotactic Radiosurgery (SRS): ADC|DCE-MRI is a quantitative method that allows for non-invasive analysis of tumor vascular characteristics. Diffusion-weighted imaging, dependent on motion of water molecules, provides information regarding tissue integrity. Apparent diffusion coefficient (ADC) values in the normal brain parenchyma, and those in brain tumors were measured. Patients had a DCE-MRI at baseline and at 1 week and 2 months after SRS.|2 months after SRS|Intent-to-treat; only 12 of 15 patients had DCE-MRI results at both time points.||10(-6) mm^2/s||Inter-Quartile Range|Median
806880|NCT01017250|Secondary|Dynamic Contrasted-enhanced MRI (DCE-MRI) Perfusion Indices at 1 Week After Stereotactic Radiosurgery (SRS): ADC|DCE-MRI is a quantitative method that allows for non-invasive analysis of tumor vascular characteristics. Diffusion-weighted imaging, dependent on motion of water molecules, provides information regarding tissue integrity. Apparent diffusion coefficient (ADC) values in the normal brain parenchyma, and those in brain tumors were measured. Patients had a DCE-MRI at baseline and at 1 week and 2 months after SRS.|1 week after SRS|Intent-to-treat; only 12 of 15 patients had DCE-MRI results at both time points.||10(-6) mm^2/s||Inter-Quartile Range|Median
806881|NCT01017250|Secondary|Dynamic Contrasted-enhanced MRI (DCE-MRI) Perfusion Indices at 2 Months After Stereotactic Radiosurgery (SRS): EVF|DCE-MRI is a quantitative method that allows for non-invasive analysis of tumor vascular characteristics. Patients had a DCE-MRI at baseline and at 1 week and 2 months after SRS.|2 months after SRS|Intent-to-treat; only 12 of 15 patients had DCE-MRI results at both time points.||10(-1)||Inter-Quartile Range|Median
806882|NCT01017250|Secondary|Dynamic Contrasted-enhanced MRI (DCE-MRI) Perfusion Indices at 1 Week After Stereotactic Radiosurgery (SRS): EVF|DCE-MRI is a quantitative method that allows for non-invasive analysis of tumor vascular characteristics. By measuring extracellular extravascular volume fraction (EVF) it is possible to gain information on brain tissue perfusion. Patients had a DCE-MRI at baseline and at 1 week and 2 months after SRS.|1 week after SRS|Intent-to-treat; only 12 of 15 patients had DCE-MRI results at both time points.||10(-1)||Inter-Quartile Range|Median
806883|NCT01017250|Secondary|Dynamic Contrasted-enhanced MRI (DCE-MRI) Perfusion Indices at 2 Months After Stereotactic Radiosurgery (SRS): AUC|DCE-MRI is a quantitative method that allows for non-invasive analysis of tumor vascular characteristics. Area under the curve (AUC) is utilized to measure the signal enhancement ratio washout volume and could be predictive of cancer treatment response. It is possible AUC could be used as a prognostic indicator of the eventual response. Patients had a DCE-MRI at baseline and at 1 week and 2 months after SRS.|2 months after SRS|Intent-to-treat; only 12 of 15 patients had DCE-MRI results at both time points.||mmol/kg∙s||Inter-Quartile Range|Median
806884|NCT01017250|Secondary|Dynamic Contrasted-enhanced MRI (DCE-MRI) Perfusion Indices at 1 Week After Stereotactic Radiosurgery (SRS): AUC|DCE-MRI is a quantitative method that allows for non-invasive analysis of tumor vascular characteristics. Area under the curve (AUC) is utilized to measure the signal enhancement ratio washout volume and could be predictive of cancer treatment response. It is possible AUC could be used as a prognostic indicator of the eventual response. Patients had a DCE-MRI at baseline and at 1 week and 2 months after SRS.|1 week after SRS|Intent-to-treat; only 12 of 15 patients had DCE-MRI results at both time points.||mmol/kg∙s||Inter-Quartile Range|Median
806885|NCT01017250|Secondary|Dynamic Contrasted-enhanced MRI (DCE-MRI) Perfusion Indices at 2 Months After Stereotactic Radiosurgery (SRS): K-trans|DCE-MRI is a quantitative method that allows for non-invasive analysis of tumor vascular characteristics. K-trans is the widely accepted MR method for quantitating brain tumor microvascular permeability( a measure of blood transport.) K-trans will indicate a combination of both flow and permeability properties of tissue. K-trans will indicate the tissue perfusion per unit volume with a reduction in K-trans suggesting an increased anti-tumor effect and potentially improved outcome. Patients had a DCE-MRI at baseline and at 1 week and 2 months after SRS.|2 months after SRS|Intent-to-treat; only 12 of 15 patients had DCE-MRI results at both time points.||10(-2) min(-1)||Inter-Quartile Range|Median
806886|NCT01017250|Secondary|Dynamic Contrasted-enhanced MRI (DCE-MRI) Perfusion Indices at 1 Week After Stereotactic Radiosurgery (SRS): K-trans|DCE-MRI is a quantitative method that allows for non-invasive analysis of tumor vascular characteristics. K-trans is the widely accepted MR method for quantitating brain tumor microvascular permeability( a measure of blood transport.) K-trans will indicate a combination of both flow and permeability properties of tissue. K-trans will indicate the tissue perfusion per unit volume, with a reduction in K-trans suggesting an increased anti-tumor effect and potentially improved outcome. Patients had a DCE-MRI at baseline and at 1 week and 2 months after SRS.|1 week after SRS|Intent-to-treat; only 12 of 15 patients had DCE-MRI results at both time points.||10(-2) min(-1)||Inter-Quartile Range|Median
806887|NCT01017250|Secondary|Steroid Usage After Stereotactic Radiosurgery (SRS)|Number of patients using steroids at baseline and at 2 months after SRS.|2 months after SRS 2 months after SRS 2 months after SRS|||participants|||Number
806888|NCT01017250|Secondary|Performance Status at 2 Months After Stereotactic Radiosurgery (SRS)|"Number of patients with a 10% decline in Karnofsky Performance Status (KPS) from baseline to 2 months after SRS. KPS is rated on a 0 to 100 scale representing a patient's ability to perform normal activity, ability to do active work, and the need for assistance. A score of 100 is perfect health and 0 represents death."|2 months after SRS|Intent to Treat: only 13 out of 15 patients completed month 2 KPS scores||participants|||Number
806889|NCT01017250|Secondary|Cognition at 2 Months After Stereotactic Radiosurgery (SRS) as Measured by the Trail Making Test (TMT)|Cognition as measured by the change in scores on the Trail Making Test (TMT). The TMT consists of two parts. Part A (TMT-A) requires an individual to draw lines sequentially connecting 25 encircled numbers distributed on a sheet of paper. Task requirements are similar for Part B (TMT-B) except the person must alternate between numbers and letters (e.g., 1, A, 2, B, 3, C, etc.). The score on each part represents the amount of time required to complete the task. Shorter time scores indicates improved cognition. Change score = score at 2 months after SRS - score at baseline. Negative change scores indicate improved cognition.|2 months after SRS|Intent to treat: only 14 of 15 patients completed the month 2 questionnaire||seconds||Standard Error|Mean
806927|NCT01017653|Secondary|Relationship Between Epidermal Growth Factor Receptor (EGF-R) Mutational Analysis and Efficacy or Toxicity|Number of participants with an abnormal fluorescence in situ hybridization (FISH) interpretation that 1) survived < 6 months and 2) experienced a ≥ grade 3 toxicity as graded per CTCAE v.3.0|16 months|Insufficient data to analyze the relationship between EGF-R analysis and efficacy or toxicity. Data was not collected for this outcome.||participants|||Number
806890|NCT01017250|Secondary|Cognition at 2 Months After Stereotactic Radiosurgery (SRS)as Measured by the Mini-Mental State Exam ( MMSE)|Cognition as measured by the change in the Mini-Mental State Exam (MMSE) scores from baseline to 2 months after SRS. The MMSE is an 11-item measure that tests five areas of cognitive function: orientation, registration, attention and calculation, recall and language. The maximum score is 30. Change score = score at 2 months after SRS - score at baseline. Higher scores for this scale indicate improved quality of life(QOL). Positive change scores indicate improved cognition.|2 months after SRS|Intent to Treat: only 14 patients out of 15 completed the month 2 questionnaire||units on a scale||Standard Error|Mean
806891|NCT01017250|Secondary|Change in Quality of Life From Baseline to 2 Months After Stereotactic Radiosurgery (SRS)|Quality of life as measured by the change in Functional Assessment of Cancer Therapy-Brain (FACT-Br) scores from baseline to 2 months after SRS. The FACT-Br (version 4) is comprised of the Functional Assessment of Cancer Therapy-General (FACT-G), a 27-item core questionnaire evaluating the domains of physical, family/social, emotional and functional well-being, with the addition of 23 brain cancer specific questions. The FACT-G total score is the sum of the four FACT-G domain scores. The Brain Cancer Subscale (BrCS) is the sum of 19 brain cancer specific questions. The FACT-Br Trial Outcome Index (TOI) is the sum of the BrCS score and the physical and family/social domain scores. The FACT-Br total score is the sum of the FACT-G total score and the BrCS score. Higher scores for all scales indicate improved quality of life (QOL).Change score = score at 2 months after SRS - score at baseline. Positive change scores indicate improved quality of life.|2 months after SRS|Intent to Treat; only 10 patients out of 15 completed the month 2 questionnaire.||units on a scale||Standard Error|Mean
806892|NCT01017250|Secondary|Overall Survival(OS)|Time in months from the start of stereotactic radiosurgery (SRS) to date of death due to any cause. Patients alive as of the last follow-up had OS censored at the last follow-up date. Median OS was estimated using a Kaplan-Meier curve.|2 years|Intent to treat||months||95% Confidence Interval|Median
806893|NCT01017250|Secondary|Radiographic Response at Month 2|Radiographic response at 2 months after stereotactic radiosurgery (SRS) assessed by MRI and based on modified Response Assessment in Neuro-Oncology (RANO) criteria.Per RANO, complete response (CR) is the disappearance of all target lesions;Partial Response(PR)is a >=30% decrease in the sum of the longest diameter of target lesions.|2 months after SRS|Intent to treat||Participants|||Number
806894|NCT01017250|Secondary|Progression-free Survival (PFS)|Time in months from the start of stereotactic radiosurgery (SRS) to the date of first progression according to Revised Assessment in Neuro-Oncology (RANO)criteria, or to death due to any cause. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve. Per RANO, progression is defined as a 20% increase in the sum of the longest diameter of target lesions,or a measurable increase in a non-target lesion or the appearance of new lesions.|1 year|Intent to treat||months||95% Confidence Interval|Median
806895|NCT01017250|Primary|Central Nervous System (CNS) Toxicity|"Number of participants who experience Grade 3 or higher adverse events in the Nervous System Disorder domain of Common Toxicity Criteria for Adverse Events (CTCAE) v4.0."|2 months after Stereotactic Radiosurgery|The number of participants with CNS toxicity is reported.||participants|||Number
806896|NCT01017263|Primary|Pre and Post Study Fasting Blood Sugar and Two Hour Post Prandial.|The study was terminated due to lack of enrollment therefore outcome measures were not assessed. If completed, the expected outcomes would have shown an improvement of the subject's fasting and 2 hour post prandial glucose values, insulin levels and HbA1c. However, all of the subjects recruited did not have abnormal values to start with. The two subjects who were enrolled were the younger kids to which the entry lab criteria do not apply.|Baseline to end of study|Study terminated early - no analysis performed on the single subject with data.|||||
806897|NCT01017497|Secondary|Rate of Death Due to Neurologic Causes|The rate of death due to neurologic causes is defined as the percentage of participants whose death is attributable to the progression of neurological disease.|24 months after SRS|||percentage of participants|||Number
806898|NCT01017497|Secondary|Cognition at 3 Months After SRS as Measured by the Trail Making Test (TMT)|Cognition as measured by the change in scores on the Trail Making Test (TMT) from baseline to 3 months after SRS. The TMT consists of two parts. Part A (TMT-A) requires an individual to draw lines sequentially connecting 25 encircled numbers distributed on a sheet of paper. Task requirements are similar for Part B (TMT-B) except the person must alternate between numbers and letters (e.g., 1, A, 2, B, 3, C, etc.). The score on each part represents the amount of time required to complete the task. Change score = score at 3 months after SRS - score at baseline. Negative change scores indicate improved cognition.|Baseline to 3 months after SRS|Only 24 patients of 49 enrolled completed both the baseline and month 3 questionnaire.||Change in seconds baseline to 3 months||Standard Error|Mean
806899|NCT01017497|Secondary|Cognition at 3 Months After SRS as Measured by the Mini-Mental State Exam (MMSE)|Cognition as measured by the change in MMSE scores from baseline to 3 months after SRS. The MMSE is an 11-item measure that tests five areas of cognitive function: orientation, registration, attention and calculation, recall and language. The minimum score is 0 and teh maximum score is 30 with higher MMSe scores indicating better cognition. Change score = score at 3 months after SRS - score at baseline. Positive change scores indicate improved cognition.|Baseline to 3 months after SRS|Only 24 patients of 49 enrolled completed both the baseline and month 3 questionnaire.||Change in score from baseline to 3 month||Standard Error|Mean
806900|NCT01017497|Secondary|Quality of Life at 3 Months After SRS as Measured by the Functional Assessment of Cancer Therapy-Brain (FACT-Br)|Quality of life as measured by the change in FACT-Br scores from baseline to 3 months after SRS. The FACT-Br (version 4) is comprised of the Functional Assessment of Cancer Therapy-General (FACT-G), a 27-item core questionnaire evaluating the domains of physical, family/social, emotional and functional well-being, with the addition of 23 brain cancer specific questions. The FACT-G total score is the sum of the four FACT-G domain scores. The Brain Cancer Subscale (BrCS) is the sum of 19 brain cancer specific questions. The FACT-Br Trial Outcome Index (TOI) is the sum of the BrCS score and the physical and family/social domain scores. The FACT-Br total score is the sum of the FACT-G total score and the BrCS score. Change score = score at 3 months after SRS - score at baseline. Positive change scores indicate improved quality of life.|Baseline to 3 months after SRS|Only 24 patients of 49 enrolled completed both the baseline and month 3 questionnaire.||Change in score from baseline to 3 month||Standard Error|Mean
820717|NCT01147497|Secondary|The Use of Adjunctive Measures Including Ultrasound Guidance or Cervical Dilation to Insert the IUD||assessed immediately after IUD insertion|||participants|||Number
806902|NCT01017497|Secondary|12 Month Rate of Distant Brain Metastases|The 12-month rate of distant brain metastases is defined as the percentage of participants with the appearance of new brain metastasis located away from the previously treated lesion (i.e. distant brain failure) 12 months after SRS. Time to the appearance of new brain metastasis was defined as the time between SRS and distant brain failure. Patients without new distant brain metastases as of the last follow-up were censored at the last follow-up date. Kaplan-Meier methods were used to describe the time to distant brain failure.|12 month after SRS|The rate of distant brain metastases is a patient-specific outcome. Of the 49 patients enrolled, six had insufficient post-SRS imaging data to be included in this analysis.||percentage of participants||95% Confidence Interval|Number
806903|NCT01017497|Secondary|Rate of Radionecrosis at SRS Treatment Site|The rate of radionecrosis is defined as the proportion of lesions with an indication of radiation-associated changes but no evidence of viable tumor on follow-up imaging (and confirmed by tissue biopsy whenever possible).|24 months after SRS|This is a lesion-specific outcome. A patient could have 1 lesion randomized to the 1mm arm and a different lesion randomized to the 3mm arm, the total participants analyzed will not equal 49. Of the 80 lesions, 4 of 40 lesions in the 1-mm arm and 7 of 40 in the 3-mm arm had insufficient post-SRS imaging data to be included in this analysis.||proportion of lesions|Participants|95% Confidence Interval|Number
806904|NCT01017497|Primary|12-month Local Control Rate|The 12-month local control rate is the percentage of lesions without recurrence at the lesion site 12 months after SRS. Time to local recurrence was defined as the time between SRS and local recurrence. If local recurrence did not occur, the time to local recurrence was censored at last follow-up (including deaths without local recurrence). Kaplan-Meier methods were used to describe the time to local recurrence.|12 months after SRS|This is a lesion-specific outcome. A patient could have 1 lesion randomized to the 1mm arm and a different lesion randomized to the 3mm arm, the total participants analyzed will not equal 49. Of the 80 lesions, 4 of 40 lesions in the 1-mm arm and 7 of 40 in the 3-mm arm had insufficient post-SRS imaging data to be included in this analysis.||percentage of lesions|Participants|95% Confidence Interval|Number
806905|NCT01017536|Secondary|Mtb-specific T Cell Response in HIV-infected BCG-vaccinated Adult Subjects With no Evidence of TB Disease|Intracellular cytokine staining (ICS) assay immune response was expressed as the percentage of CD4+ and CD8+ T cells producing any one of three cytokines (IFN-γ, TNF-α, or IL-2) or any combination of the three cytokines simultaneously after stimulation with Ag85A, Ag85B, and TB10.4 peptide pools.|Study days 28 and 56|percentage of CD4 or CD8 T-cell response||percentage of T-cell response||95% Confidence Interval|Median
806906|NCT01017536|Secondary|Change in HIV Viral Load in HIV-infected, BCG-vaccinated Adult Subjects Before and After Administration of AERAS-402 (From Day 1 to Day 182)||6 months (day 182) post Study Day 0 vaccination.|||Change in copies/mL over time||95% Confidence Interval|Median
806907|NCT01017536|Primary|CD4+ Lymphocyte Count|Assess the effect of AERAS-402 on the CD4+ lymphocyte count after 6 months in HIV-infected, BCG-vaccinated adult subjects with no evidence of active tuberculosis (TB disease) Change in cells/mm^3 pre-vaccination to Study Day 182|CD4+ counts from samples collected on Study days 0 and 182.|||cells/mm^3||95% Confidence Interval|Median
806908|NCT01017549|Secondary|Serious Adverse Device Related Events Reported During the Course of the Study Through 6 Month Follow-up.|Serious adverse device related events reported from treatment through 6 month follow-up and at 1-year follow-up are reported.|Through 6 months|All patients treated were analyzed at 6 months except for 1 patient who was lost to follow-up.||events|||Number
806909|NCT01017549|Primary|Number of Participants With Delivery of 34 Gy in 10 Fractions|Successful delivery of the radiation treatment defined as a total 34 Gy in a total of 10 fractions, 3.4 Gy per fraction. (Gray = GY is a measure of radiation dose delivered to tissue)|measured at end of 10th fraction, usually within 7 days|All patients treated were analyzed||Participants|||Number
806910|NCT01017575|Other Pre-specified|Number of Participants With Grade 3 to 4 Laboratory Abnormalities|Clinically significant change in marked laboratory abnormalities (Grade 3 to 4) included: Aspartate aminotransferase (AST)- Grade 3 as >5.0 to 10.0*Upper Limit of Normal (ULN), Grade 4 as >10.0*ULN; Hemoglobin- Grade 3 as 7.0 to 8.9 g/dL, Grade 4 as <7.0 g/dL; Neutrophils- Grade 3 as 0.5 to 0.749*10^9/L, Grade 4 as <0.5*10^9/L; Lymphocytes- Grade 3 as 0.35 to 0.499*10^9/L, Grade 4 as <0.35*10^9/L; Platelets- Grade 3 as 25000 to 49999*10^9/L, Grade 4 as <25000 10^9/L; white blood cells (WBC) - Grade 3 as 1000 to 1499*10^9/L, Grade 4 as <1000*10^9/L and Lipase- Grade 3 as 3.1-5.0*ULN, Grade 4 as >5.0*ULN.|From screening up to Week 12 (treatment period)|All treated participants who received at least 1 dose of study therapy.||Participants|||Number
806911|NCT01017575|Other Pre-specified|Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Who Died.|AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not has a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.|From Baseline up to 30 days after last dose of study drug|All treated participants who received at least 1 dose of study therapy.||participants|||Number
806912|NCT01017575|Primary|Percentage of Participants With Extended Rapid Virologic Response (eRVR)|eRVR was defined as undetectable hepatitis C virus (HCV) RNA ie, HCV RNA <15 IU/mL, the lower limit of detection at both Weeks 4 and 12.|From Week 4 up to Week 12|All treated participants who received at least 1 dose of study therapy.||percentage of participants|||Number
806913|NCT01017575|Secondary|Percentage of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 12 and Follow-up Week 24|SVR at Follow-up Week 12 (SVR12) and SVR at Follow-up week 24 (SVR24) was defined as hepatitis C virus (HCV) RNA <15 IU/mL at follow-up Weeks 12 and 24.|Follow up Week 12, Follow up Week 24|All treated participants who received at least 1 dose of study therapy.||percentage of participants|||Number
806914|NCT01017575|Secondary|Percentage of Participants With a Complete Early Virologic Response (cEVR)|cEVR was defined as hepatitis C virus RNA <15 IU/mL at Week 12.|Week 12|All treated participants who received at least 1 dose of study therapy.||percentage of participants|||Number
806915|NCT01017575|Secondary|Percentage of Participants With Rapid Virologic Response (RVR)|RVR was defined as undetectable hepatitis C virus (HCV) RNA ie, HCV RNA <15 IU/mL, the lower limit of detection at Week 4.|Week 4|All treated participants who received at least 1 dose of study therapy.||percentage of participants|||Number
806916|NCT01017601|Secondary|Clinical Significance Change From Baseline to Day 30-59 in the LASA QOL|Quality of Life (QOL) was measured using the single-item Linear Analogue Self Assessment (LASA) on a 0-10 scale, with 0=as bad as it can be and 10=as good as it can be. The QOL scores was converted to a 100-point scale, with 0=Low QOL and 100=Best QOL. Change from baseline to day 30-59 was calculated by subtracting the baseline scores from the scores at day 30-59. Clinical Significance change over time was determined by the percentage of patients that report an improvement of more than 10 points on the 0-100 point scale.|Day 1 Cycle 1 prior to treatment (baseline) and day 30-59 (during the active monitoring phase)|All registered participants who have met eligibility criteria and who have completed both baseline and the time point of day 30-59 QOL assessments.||percentage of participants|||Number
806917|NCT01017601|Secondary|Clinical Significance Change From Baseline to Day 20-29 in the LASA QOL|Quality of Life (QOL) was measured using the single-item Linear Analogue Self Assessment (LASA) on a 0-10 scale, with 0=as bad as it can be and 10=as good as it can be. The QOL scores was converted to a 100-point scale, with 0=Low QOL and 100=Best QOL. Change from baseline to day 20-29 was calculated by subtracting the baseline scores from the scores at day 20-29. Clinical Significance change over time was determined by the percentage of patients that report an improvement of more than 10 points on the 0-100 point scale.|Day 1 Cycle 1 prior to treatment (baseline) and day 20-29 (during the active monitoring phase)|All registered participants who have met eligibility criteria and who have completed both baseline and the time point of day 20-29 QOL assessments.||percentage of participants|||Number
806918|NCT01017601|Secondary|Change From Baseline to Day 30-59 in the LASA QOL|Quality of Life (QOL) was measured using the single-item Linear Analogue Self Assessment (LASA) on a 0-10 scale, with 0=as bad as it can be and 10=as good as it can be. The QOL scores was converted to a 100-point scale, with 0=Low QOL and 100=Best QOL. Change from baseline to day 30-59 was calculated by subtracting the baseline scores from the scores at day 30-59. Negative change indicates the QOL decrease and positive change indicates the QOL improvement.|Day 1 Cycle 1 prior to treatment (baseline) and day 30-59 (during the active monitoring phase)|All registered participants who have met eligibility criteria and who have completed both baseline and the time point of day 30-59 QOL assessments.||units on a scale||Standard Deviation|Mean
806919|NCT01017601|Secondary|Change From Baseline to Day 20-29 in the LASA QOL|Quality of Life (QOL) was measured using the single-item Linear Analogue Self Assessment (LASA) on a 0-10 scale, with 0=as bad as it can be and 10=as good as it can be. The QOL scores was converted to a 100-point scale, with 0=Low QOL and 100=Best QOL. Change from baseline to day 20-29 was calculated by subtracting the baseline scores from the scores at day 20-29. Negative change indicates the QOL decrease and positive change indicates the QOL improvement.|Day 1 Cycle 1 prior to treatment (baseline) and day 20-29 (during the active monitoring phase)|All registered participants who have met eligibility criteria and who have completed both baseline and the time point of day 20-29 QOL assessments.||units on a scale||Standard Deviation|Mean
806920|NCT01017601|Secondary|Number of Participants With at Least One Grade 3 or Above Adverse Events Assessed by NCI CTCAE v4.0|Adverse events were assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grading: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death. The maximum grade for each type of adverse events were recorded for each patient.|Up to 23 months|All registered participants who have met eligibility criteria and started the treatment.||Participants|||Count of Participants
806921|NCT01017601|Secondary|Duration of Response|Duration of response was defined as the time from the date at which the patient’s earliest best objective status was first noted to be either a CR or PR to the earliest date progression was documented.|Up to 5 years|All participants with the patient's earliest best objective status was first noted to be a CR or PR.||months||95% Confidence Interval|Median
806922|NCT01017601|Secondary|Response Rate (Complete Response and Partial Response) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)|A confirmed tumor response was defined as a complete response (CR) or partial response (PR) noted as the objective status on 2 consecutive evaluations at least 6 weeks apart. Response and progression will be evaluated in this study using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all non-nodal target lesions and each target lymph node must have reduction in short axis to <1.0 cm.; Partial Response (PR), at least a 30% decrease in the sum of the longest diameters of the non-nodal target lesions and the short axes of the target lymph nodes taking as reference the Baseline Sum of Diameters; Overall Response (OR) = CR + PR.|Up to 5 years|All registered participants who have met eligibility criteria and started the treatment.||percentage of participants|||Number
806923|NCT01017601|Secondary|Overall Survival|Overall survival was defined as the time from study enrollment (randomization) to the time of death from any cause or last follow-up.|Time from randomization to death or last follow-up (up to 5 years)|All registered participants who have met eligibility criteria and started the treatment.||months||95% Confidence Interval|Median
806924|NCT01017601|Primary|Progression-free Survival|The progression-free survival (PFS) was defined as the time from date of randomization to the documentation of disease progression or death as a result of any cause, whichever comes first.|Time from randomization to the disease progression or death (up to 5 years)|All registered participants who have met eligibility criteria and started the treatment.||months||95% Confidence Interval|Median
806925|NCT01017653|Secondary|Median Overall Survival (OS)|Time in months from the start of study treatment to date of death due to any cause. Patients alive as of the last follow-up had OS censored at the last follow-up date. Median OS was estimated using a Kaplan-Meier curve.|18 months|||months||95% Confidence Interval|Median
806926|NCT01017653|Secondary|Objective Response Rate|Number of participants with an objective response (complete response or partial response) based on modified Macdonald criteria. A complete response is defined as the disappearance of all enhancing rumor and mass effect, off all corticosteroids, accompanied by a stable or improving neurologic examination, and maintained for at least 4 weeks. A partial response is defined as greater than or equal to 50% reduction in tumor size on MR (magnetic resonance) / CT(computed tomography) by bi-dimensional measurement on a stable or decreasing dose of corticosteroids, accompanied by a stable or improving neurologic examination, and maintained for at least 4 weeks.|16 months|2 patients' response was unknown due to withdrawal from the study before an MRI was performed.||participants|||Number
806931|NCT01017653|Primary|6-month Progression-free Survival (PFS)|Percentage of participants surviving six months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to the Macdonald criteria, or to death due to any cause. Macdonald criteria are standard criteria in neuro-oncology. Tumor assessment was made according to the adapted MacDonald criteria based on the combined evaluation of: 1) assessment of the MRI scan for measurable, evaluable, and new lesions (made by the independent external expert too), 2) overall assessment of neurological performance (made by the investigator), and 3) concomitant steroid use (as reported by the investigator).|6 months|||percentage of participants||95% Confidence Interval|Number
806932|NCT01017731|Secondary|Area Under Concentration (AUC) During Cycle 3|The area under the concentration versus time curve over the dosing interval at steady state [AUC(tau,ss)] is reported during Cycle 3 (1 cycle=21 days).|Cycle 3 [predose and 1.25 hours (h), 2.25 h, 3.25 h, 4.25 h, 72 h, 168 h, 336 h, and 504 h postdose]|Participants who received a full dose of ramucirumab and have evaluable AUC data during Cycle 3.||hours*micrograms/milliliter (h*mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
806933|NCT01017731|Secondary|Area Under Concentration (AUC) During Cycle 2, Day 1|AUC was not calculated due to the sparse pharmacokinetic sampling employed on Cycle 2, Day 1.|Approximately Week 1 (Cycle 2, Day 1)|No participants were analyzed.|||||
806934|NCT01017731|Secondary|Area Under Concentration (AUC) During Cycle 1, Day 15|AUC was summarized once per cycle because participants only received 1 dose of IMC-1121B (ramucirumab) per cycle. Refer to secondary outcome measure 9 for AUC during Cycle 1 (Day 1 through Day 15).|Approximately Week 3 (Cycle 1, Day 15)|No participants analyzed.|||||
806935|NCT01017731|Secondary|Area Under Concentration (AUC) During Cycle 1, Day 8|AUC was summarized once per cycle because participants only received 1 dose of IMC-1121B (ramucirumab) per cycle. Refer to secondary outcome measure 9 for AUC during Cycle 1 (Day 1 through Day 15).|Approximately Week 2 (Cycle 1, Day 8)|No participants were analyzed.|||||
806936|NCT01017731|Secondary|Area Under Concentration (AUC) During Cycle 1, Day 4|AUC was summarized once per cycle because participants only received 1 dose of IMC-1121B (ramucirumab) per cycle. Refer to secondary outcome measure 9 for AUC during Cycle 1 (Day 1 through Day 15).|Approximately Week 1 (Cycle 1, Day 4)|No participants were analyzed.|||||
806937|NCT01017731|Secondary|Area Under Concentration (AUC) During Cycle 1|The area under the concentration versus time curve from time 0 to infinity [AUC(0-inf)] is reported during Cycle 1 (1 cycle=21 days).|Cycle 1 [2.25 hours (h), 3.25 h, 4.25 h, 72 h, 168 h, 336 h postdose]|Participants who received a full dose of ramucirumab and have evaluable AUC data during Cycle 1.||hours*micrograms/milliliter (h*mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
806938|NCT01017731|Secondary|Maximum Concentration (Cmax) During Cycle 3|The maximum observed serum concentration of IMC-1121B (ramucirumab) at steady state (Cmax,ss) during Cycle 3 (1 cycle=21 days).|Cycle 3 [predose and 1.25 hours (h), 2.25 h, 3.25 h, 4.25 h, 72 h, 168 h, 336 h, and 504 h postdose]|Participants who received a full dose of ramucirumab and have evaluable Cmax data during Cycle 3.||micrograms per milliliter (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
806939|NCT01017731|Secondary|Maximum Concentration (Cmax) During Cycle 2|Cmax was not calculated due to the sparse pharmacokinetic sampling employed on Cycle 2, Day 1.|Cycle 2 (predose and 1.25 hours postdose)|No participants were analyzed.|||||
806940|NCT01017731|Secondary|Maximum Concentration (Cmax) During Cycle 1, Day 15|Cmax was summarized once per cycle because participants only received 1 dose of IMC-1121B (ramucirumab) per cycle. Refer to secondary outcome measure 3 for Cmax during Cycle 1.|Approximately Week 3 (Cycle 1, Day 15)|No participants were analyzed.|||||
806941|NCT01017731|Secondary|Maximum Concentration (Cmax) During Cycle 1, Day 8|Cmax was summarized once per cycle because participants only received 1 dose of IMC-1121B (ramucirumab) per cycle. Refer to secondary outcome measure 3 for Cmax during Cycle 1.|Approximately Week 2 (Cycle 1, Day 8)|No participants were analyzed.|||||
806942|NCT01017731|Secondary|Maximum Concentration (Cmax) During Cycle 1, Day 4|Cmax was summarized once per cycle because participants only received 1 dose of IMC-1121B (ramucirumab) per cycle. Refer to secondary outcome measure 3 for Cmax during Cycle 1.|Approximately Week 1 (Cycle 1, Day 4)|No participants were analyzed.|||||
806943|NCT01017731|Secondary|Maximum Concentration (Cmax) During Cycle 1|Maximum observed concentration of IMC-1121B (ramucirumab) in serum during Cycle 1 (1 cycle=21 days).|Cycle 1 [2.25 hours (h), 3.25 h, 4.25 h, 72 h, 168 h, 336 h postdose]|Participants who received a full dose of ramucirumab and have evaluable Cmax data during Cycle 1.||micrograms per milliliter (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
806944|NCT01017731|Secondary|Number of Participants With Drug-Related Adverse Events (AEs)|Data presented are the number of participants who experienced treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), Grade 3 or higher TEAEs, or adverse events (AEs) leading to discontinuation of treatment that were considered to be related to ramucirumab. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events section.|Baseline up to data cut off (approximately 105.6 weeks)|Safety population: participants who received any quantity of ramucirumab, regardless of their eligibility for the study.||participants|||Number
806945|NCT01017731|Primary|Change From Baseline to Cycle 3 in QT/Corrected QT (QTc) Interval Prolongation in Participants|All electrocardiogram (ECG) tests were performed in triplicate prior to ramucirumab treatment. QT is the interval between the Q and T waves and QTc is the QT corrected for heart rate using Fridericia's formula: QTc = QT/RR^0.33 where RR is the interval between 2 R waves. Each participant's mean QT/QTc value was calculated for each ECG test during Cycle 3 and compared to his/her mean pretreatment QT/QTc value. The greatest change from baseline during Cycle 3 was reported. QTc prolongation is defined as a QTc exceeding 10 milliseconds (msec) with a lower 90% confidence interval (CI) exceeding 5 msec at any postdose time points per the International Conference on Harmonization (ICH) E14 guidelines for non-thorough QT studies (ICH 2005; ICH 2008). Least squares (LS) mean was calculated using a linear mixed model for repeated measures (MMRM) and adjusted for serum concentration.|Baseline, Cycle 3 (1 cycle=21 days)|Participants who received a full study dose of ramucirumab in Cycle 3 and had at least 1 pretreatment ECG and postinfusion ECG at scheduled times as specified in the protocol.||milliseconds (msec)||90% Confidence Interval|Least Squares Mean
807277|NCT01011556|Secondary|Pharmacokinetics Parameters: Area Under the Curve (AUC)|Due to high intra-subject variability, data was not analyzed for this outcome measure.|Baseline, 1 Month, 3 Months, and 12 Months|Due to high intra-subject variability, zero participants were analyzed on this outcome measure.|||||
806946|NCT01017874|Secondary|Time to Worsening of Health-Related Quality of Life (TWQ) Using the Participant-Rated Lung Cancer Symptom Scale (LCSS)|The LCSS data included participant ratings of 6 symptoms (loss of appetite, fatigue, cough, dyspnea, hemoptysis, and pain) and 3 summary items (overall symptom severity, interference with daily activities, and overall QoL). Participants recorded their ratings for each item, by placing a mark on a visual analog scale (VAS) that ranged from 0 millimeter (mm) (lower symptom burden, less interference with normal activity, or better QoL) to 100 mm (higher symptom burden, more interference with normal activity, or worse QoL). TWQ was evaluated from date of randomization to first date of worsening, defined as a half standard deviation change as determined from the corresponding baseline item score in the pooled treatment group. For participants not known to have worsened or who were lost to follow-up, TWQ was censored at date of the participant's last LCSS assessment.|Every cycle while on-study therapy and at 3 months post last dose|Participants who received at least 1 dose of study treatment and had LCSS data available. Participants censored (Pemetrexed + Cisplatin + Gefitinib, Gefitinib): Loss of appetite (33,59), Fatigue (42,54), Cough (52,65), Dyspnea (51,66), Hemoptysis (69,74), Pain (48,67), Overall symptoms (52,63), Interference (42,59), Overall QoL (51,51).||months||Full Range|Median
806947|NCT01017874|Secondary|Duration of Tumor Response|The duration of a complete response (CR) or partial response (PR) using Response Evaluation Criteria in Solid Tumors (RECIST v1.0) criteria was defined as the time from first objective status assessment of CR or PR to the first time of objective disease progression or death as a result of any cause. CR was defined as the disappearance of all tumor lesions. PR was defined as at least a 30% decrease in sum of longest diameter (LD) of target lesions taking as reference the baseline sum of LDs or complete disappearance of target lesions, with persistence (but not worsening) of 1 or more non-target lesions and no new lesions having appeared. Participants who were not known to have died or had objective progression of disease as of the data-inclusion cut-off date were censored at the date of the participant’s last complete objective progression-free disease assessment prior to that cut-off date.|Date of initial response to the date of measured PD or death up to 34.43 months|A subset of the Intent-to-treat (ITT) population: All data from all randomized participants according to the treatment they were assigned who had confirmed CR or PR. Pemetrexed + Cisplatin + Gefitinib= 19, Gefitinib= 9.||months||95% Confidence Interval|Median
806948|NCT01017874|Secondary|Time to Progressive Disease (TtPD)|TtPD was defined as the time from randomization to the first date of objectively determined progressive disease (PD). For participants who were not known to have had objective progression of disease as of the data-inclusion cut-off date for a particular analysis, or who had died without objective progression of disease, TtPD was censored at the date of the participant’s last objective progression-free disease assessment prior to cut-off date.|Randomization to the first date of measured PD up to 37.32 months|Intent-to-treat (ITT) population: All data from all randomized participants according to the treatment they were assigned. Censored participants: Pemetrexed + Cisplatin + Gefitinib (G) =37, G=26.||months||95% Confidence Interval|Median
806949|NCT01017874|Secondary|Percentage of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) [Disease Control Rate (DCR)]|DCR was defined as the percentage of randomized participants with overall response of CR, PR or SD using Response Evaluation Criteria in Solid Tumors (RECIST v1.0) criteria. CR was defined as the disappearance of all tumor lesions; PR was defined as at least a 30% decrease in sum of longest diameter (LD) of target lesions taking as reference the baseline sum LDs or complete disappearance of target lesions, with persistence (but not worsening) of 1 or more non-target lesions and no new lesions having appeared; SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference the smallest sum LD. PD defined as at least 20% increase in the sum of LD of target, lesions taking as reference, the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions or progression of nontarget lesions.|Randomization up to 37.52 months|Intent-to-treat (ITT) population: All data from all randomized participants according to the treatment they were assigned.||percentage of participants||95% Confidence Interval|Number
806950|NCT01017874|Secondary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Tumor Response Rate (TRR)]|TRR was defined as the percentage of randomized participants having a best overall study response of CR or PR using Response Evaluation Criteria in Solid Tumors (RECIST v1.0) criteria. CR was defined as the disappearance of all target lesions; PR was defined as at least a 30% decrease in sum of longest diameter (LD) of target lesions taking as reference the baseline sum LDs or complete disappearance of target lesions, with persistence (but not worsening) of 1 or more non-target lesions and the appearance of no new lesions.|Randomization up to 37.52 months|Intent-to-treat (ITT) population: All data from all randomized participants according to the treatment they were assigned.||percentage of participants||95% Confidence Interval|Number
806951|NCT01017874|Secondary|Overall Survival (OS)|OS was the duration from randomization to the date of death from any cause. For participants who were not known to have died as of the data-inclusion cut-off date for a particular analysis, OS was censored at the date of last contact prior to the data inclusion cutoff date (contacts considered in the determination of last contact date included adverse event date, lesion assessment date, visit date, and last known alive date).|Randomization up to date of death from any cause up to 57.13 months|ITT population: All data from all randomized participants according to the treatment they were assigned.||months||95% Confidence Interval|Median
806952|NCT01017874|Primary|Progression Free Survival (PFS)|PFS was defined as the time from date of randomization to the objective disease progression or death due to any cause. Response was defined using Response Evaluation Criteria in Solid Tumors (RECIST v1.0) criteria. Progressive disease (PD) was defined as at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions. Participants who did not have a complete baseline disease assessment were censored at the date of randomization, regardless if PD was objectively determined or if participant died or if a participant was not known to have died or have objective PD at the data inclusion cutoff date. PFS was censored at the last complete objective progression-free disease assessment date.|Randomization to the first date of measured PD or death up to 37.32 months|Intent-to-treat (ITT) population: All data from all randomized participants according to the treatment they were assigned. Censored participants: Pemetrexed+Cisplatin+Gefitinib=32, Gefitinib=22.||months||95% Confidence Interval|Median
822939|NCT01165983|Secondary|Absolute Change in Inflammatory Cytokines and Growth Factors, Osteopontin, ng/mL||12 Weeks post-randomization|||ng/mL||Inter-Quartile Range|Median
806953|NCT01017952|Secondary|Change From Baseline in Trough FEV1 at Week 52 (Visit 11)|Pulmonary function was measured by forced expiratory volume in one second (FEV1). Trough FEV1 was defined as the 24-hour post-dose FEV1 assessment, which was obtained at each visit. Analysis performed using a repeated measures model with covariates of treatment, smoking status at Screening (stratum), baseline (pre-dose Day 1), centre grouping, Week, Week by Baseline, and Week by treatment interactions.|Baseline to Visit 11 (Week 52)/Early Withdrawal|ITT Population. Number of participants presented represent those with data available at the time point being presented, however all participants in the ITT population without missing covariate information and with at least one post Baseline measurement are included in the analysis.||Liters||Standard Error|Least Squares Mean
806954|NCT01017952|Secondary|Annual Rate of Exacerbations Requiring Systemic/Oral Corticosteroids Expressed as Least Square Mean|The annual rate of COPD exacerbations during the treatment period (per participant per year) that required systemic/oral corticosteroids was assessed. An exacerbation of COPD is defined as the worsening of two or more major symptoms (dyspnea, sputum volume, sputum purulence [color]) for at least two consecutive days; or the worsening of any one major symptom together with any one of the minor symptom (sore throat, cold, fever without other cause, increased cough, increased wheeze) for at least two consecutive days. The COPD exacerbation was categorized as mild, moderate, and severe by the investigator. Mild: worsening symptoms of COPD that were self-managed by the participant. Mild exacerbations were not associated with the use of oral corticosteroids or antibiotics. Moderate: worsening symptoms of COPD that required treatment with oral corticosteroids and/or antibiotics. Severe: worsening symptoms of COPD that required treatment with in-patient hospitalization.|From the start of the double blind study medication until Visit 11 (Week 52)/Early Withdrawal|Intent-to-Treat (ITT) Population: all par. randomized who received at least 1 dose of study drug and with available data for analysis. Analysis used a negative binomial regression model with covariates of trt, smoking status at Screening, Baseline pre-dose Day 1 % predicted FEV1 and region and with logarithm of time on trt as an offset variable.||Exacerbations per participant per year||95% Confidence Interval|Least Squares Mean
806955|NCT01017952|Secondary|Time to First Occurrence of Moderate or Severe COPD Exacerbation|Time to first occurrence analyzed by using a Cox proportional hazards model with covariates of treatment, smoking status at screening (stratum), baseline disease severity (pre-dose Day 1 % predicted FEV1) and centre grouping. An exacerbation of COPD is defined as the worsening of two or more major symptoms (dyspnea, sputum volume, sputum purulence [color]) for at least two consecutive days; or the worsening of any one major symptom together with any one of the minor symptoms (sore throat, cold, fever without other cause, increased cough, increased wheeze) for at least two consecutive days. A moderate exacerbation is defined as worsening symptoms of COPD that required treatment with oral corticosteroids and/or antibiotics. A severe exacerbation is defined as worsening symptoms of COPD that required treatment with in-patient hospitalization. The number of participants with a moderate or severe COPD exacerbation while on treatment are presented.|From the start of the double blind study medication until Visit 11 (Week 52)/Early Withdrawal|ITT Population||Participants|||Number
806956|NCT01017952|Primary|Annual Rate of Moderate and Severe COPD Exacerbations Expressed as Least Square Mean|The annual rate of moderate and severe chronic obstructive pulmonary disease (COPD) exacerbations during the treatment (trt) period (per participant [par.] per year) was assessed. An exacerbation of COPD, is defined as the worsening of two or more major symptoms (dyspnea, sputum volume, sputum purulence [color]) for at least two consecutive days; or the worsening of any one major symptom together with any one of the minor symptoms (sore throat, cold, fever without other cause, increased cough, increased wheeze) for at least two consecutive days. The COPD exacerbation was categorized as mild, moderate and severe by the investigator. Mild: worsening symptoms of COPD that were self-managed by the par. without the use of oral corticosteroids or antibiotics; Moderate: worsening symptoms of COPD that required treatment with oral corticosteroids and/or antibiotics; Severe: worsening symptoms of COPD that required treatment with in-patient hospitalization.|From the start of the double blind study medication until Visit 11 (Week 52)/Early Withdrawal|Intent-to-Treat (ITT) Population: all par. randomized who received at least 1 dose of study drug and with available data for analysis. Analysis used a negative binomial regression model with covariates of trt, smoking status at Screening, Baseline pre-dose Day 1 % predicted FEV1 and region and with logarithm of time on trt as an offset variable.||Exacerbations per participant per year||95% Confidence Interval|Least Squares Mean
806957|NCT01018030|Secondary|Number of Participants Who Require the Use of an Antibiotic Due to the Development of Fulminant Bacterial Rhinosinusitis (FBRS)|Participants who required the use of an antibiotic due to the development of FBRS during the 2-week treatment period and the 2-week follow-up period were included in the analysis.|4 weeks|ITT Population||participants|||Number
806958|NCT01018030|Secondary|Mean Change From Baseline Over the Entire Treatment Period in the PM Postnasal Drip Score|Mean change from baseline was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The score ranged from 0 to 3. Change from baseline in the PM postnasal drip score was calculated as the PM postnasal drip score averaged over the entire treatment period minus the PM postnasal drip score over the baseline period (defined as the average PM postnasal drip score over the last 3 days prior to randomization).|Baseline and entire treatment period (up to 2 weeks)|ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis.||units on a scale||Standard Error|Mean
806959|NCT01018030|Secondary|Mean Change From Baseline Over the Entire Treatment Period in the AM Postnasal Drip Score|Mean change from baseline was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The score ranged from 0 to 3. Change from baseline in the AM postnasal drip score was calculated as the AM postnasal drip score averaged over the entire treatment period minus the AM postnasal drip score over the baseline period (defined as the average AM postnasal drip score over the last 3 days prior to randomization).|Baseline and entire treatment period (up to 2 weeks)|ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis.||units on a scale||Standard Error|Mean
807030|NCT01018420|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic blood samples collected pre-dose and 1 (prior to second dose), 3 (prior to fourth dose), 6 (prior to final dose), 6.17, 6.33, 6.5, 6.75, 7, 7.25, 7.5, 7.75, 8, 10, 12, 23, 36, 48, 72 and 96 hours post-dose|||ng-hr/mL||Standard Deviation|Mean
806960|NCT01018030|Secondary|Mean Change From Baseline Over the Entire Treatment Period in the Daily Postnasal Drip Score|Mean change from baseline was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The score ranged from 0 to 3. Change from baseline in the daily postnasal drip score was calculated as the daily postnasal drip score averaged over the entire treatment period minus the daily postnasal drip score over the baseline period (defined as the average daily postnasal drip score over the last 3 days prior to randomization).|Baseline and entire treatment period (up to 2 weeks)|ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis.||units on a scale||Standard Error|Mean
806961|NCT01018030|Secondary|Mean Change From Baseline Over the Entire Treatment Period in the PM Sinus Headache/Pressure or Facial Pain/Pressure Score|Mean change from baseline was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The score ranged from 0 to 3. Change from baseline in the PM sinus headache/pressure or facial pain/pressure score was calculated as the PM score averaged over the entire treatment period minus the PM score over the baseline period (defined as the average PM score over the last 3 days prior to randomization).|Baseline and entire treatment period (up to 2 weeks)|ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis.||units on a scale||Standard Error|Mean
806962|NCT01018030|Secondary|Mean Change From Baseline Over the Entire Treatment Period in the AM Sinus Headache/Pressure or Facial Pain/Pressure Score|Mean change from baseline was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The score ranged from 0 to 3. Change from baseline in the AM sinus headache/pressure or facial pain/pressure score was calculated as the AM score averaged over the entire treatment period minus the AM score over the baseline period (defined as the average AM score over the last 3 days prior to randomization).|Baseline and entire treatment period (up to 2 weeks)|ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis.||units on a scale||Standard Error|Mean
806963|NCT01018030|Secondary|Mean Change From Baseline Over the Entire Treatment Period in the Daily Sinus Headache/Pressure or Facial Pain/Pressure Score|Mean change from baseline was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The score ranged from 0 to 3. Change from baseline in the daily sinus headache/pressure or facial pain/pressure score was calculated as the daily score averaged over the entire treatment period minus the daily score over the baseline period (defined as the average daily score over the last 3 days prior to randomization).|Baseline and entire treatment period (up to 2 weeks)|ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis.||units on a scale||Standard Error|Mean
806964|NCT01018030|Secondary|Mean Change From Baseline Over the Entire Treatment Period in the PM Nasal Congestion/Stuffiness Score|Mean change from baseline was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The score ranged from 0 to 3. Change from baseline in the PM nasal congestion/stuffiness score was calculated as the PM score averaged over the entire treatment period minus the PM score over the baseline period (defined as the average PM score over the last 3 days prior to randomization).|Baseline and entire treatment period (up to 2 weeks)|ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis.||units on a scale||Standard Error|Mean
806965|NCT01018030|Secondary|Mean Change From Baseline Over the Entire Treatment Period in the AM Nasal Congestion/Stuffiness Score|Mean change from baseline was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The score ranged from 0 to 3. Change from baseline in the AM nasal congestion/stuffiness score was calculated as the AM score averaged over the entire treatment period minus the AM score over the baseline period (defined as the average AM score over the last 3 days prior to randomization).|Baseline and entire treatment period (up to 2 weeks)|ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis.||units on a scale||Standard Error|Mean
806966|NCT01018030|Secondary|Mean Change From Baseline Over the Entire Treatment Period in the Daily Nasal Congestion/Stuffiness Score|Mean change from baseline was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The score ranged from 0 to 3. Change from baseline in the daily nasal congestion/stuffiness score was calculated as the daily score averaged over the entire treatment period minus the daily score over the baseline period (defined as the average daily score over the last 3 days prior to randomization).|Baseline and entire treatment period (up to 2 weeks)|ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis.||units on a scale||Standard Error|Mean
806967|NCT01018030|Secondary|Mean Change From Baseline Over the Entire Treatment Period in PM MSS|Mean change from baseline in MSS for nasal congestion/stuffiness, sinus headache/pressure or facial pain/pressure, and postnasal drip as measured in the evening (PM) was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The total score ranged from 0 to 9. Change from baseline in PM MSS was calculated as the PM MSS averaged over the entire treatment period minus the PM MSS over the baseline period (defined as the average PM MSS over the last 3 days prior to randomization).|Baseline and entire treatment period (up to 2 weeks)|ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis.||units on a scale||Standard Error|Mean
806968|NCT01018030|Secondary|Mean Change From Baseline Over the Entire Treatment Period in AM MSS|Mean change from baseline in MSS for nasal congestion/stuffiness, sinus headache/pressure or facial pain/pressure, and postnasal drip as measured in the morning (AM) was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The total score ranged from 0 to 9. Change from baseline in AM MSS was calculated as the AM MSS averaged over the entire treatment period minus the AM MSS over the baseline period (defined as the average AM MSS over the last 3 days prior to randomization).|Baseline and entire treatment period (up to 2 weeks)|ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis.||units on a scale||Standard Error|Mean
806969|NCT01018030|Secondary|First Time to Symptom Improvement|Symptom improvement was defined as symptom scores less than or equal to 1 (i.e., mild or no symptoms) for all three major symptoms (nasal congestion/stuffiness, sinus headache/pressure or facial pain/pressure, and postnasal drip) on 2 consecutive 12-hour assessments. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe.|Entire treatment period (up to 2 weeks)|ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis.||days||Full Range|Median
806970|NCT01018030|Primary|Mean Change From Baseline in the Daily Major Symptom Score (MSS) Over the Entire Treatment Period (Weeks 1-2)|The MSS was calculated as the sum of 3 individual symptom scores for nasal congestion/stuffiness, sinus headache/pressure or facial pain/pressure, and postnasal drip. Daily MSS was calculated as the average of the morning (AM) and evening (PM) MSS. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The total score ranged from 0 to 9. Change from baseline was calculated as the daily MSS averaged over the entire treatment period minus daily MSS over the baseline period (defined as the average daily MSS over the last 3 days prior to randomization).|Baseline and entire treatment period (up to 2 weeks)|Intent-to-Treat (ITT) Population: all randomized participants who received at least one dose of double-blind study drug. Participants with missing diary data at baseline or post-baseline were not included in this analysis.||units on a scale||Standard Error|Least Squares Mean
806971|NCT01018056|Secondary|The Change From Baseline to 6-week in Scores of the Multi-Dimensional Anxiety Scale for Children (MASC)|"Multidimensional Anxiety Scale (MAS): Anxiety will be followed using the Multidimensional Anxiety Scale for Children (MASC), which has been developed by Dr. John March at Duke University and is now considered the preferred instrument for rating anxiety. The MASC asks the patient how they have been thinking and acting recently. It has a maximum possible score of 117 and a minimum score of 0. Higher score on this scale indicates greater severity of anxiety in children.
The data provided below represents the mean change (baseline minus six week) for the D-serine group (n = 9), Riluzole (n = 10), and Placebo group (n = 5). For consistency, all values weather positive or negative represent baseline minus week 6."|Baseline and 6-weeks|Please note that one subject failed to complete this assessment on week 6; therefore, the total number of participants in the placebo group for MASC is 4.||units on a scale||Standard Deviation|Mean
806972|NCT01018056|Secondary|The Change From Baseline to 6-week in Scores of the Child Depression Inventory - Short Version (CDI-S) Scale|"Depression Inventory-Short Version (DI-S): Depression severity will be rated by using the Depression Inventory-Short Version (DI-S). This 10 item scale takes about 5 minutes to complete. It has excellent psychometric properties and is designed for repeated administrations over time. The maximum possible score of 20, and a minimum score of 0. Higher score on this scale indicates greater severity of depression in children.
The data provided below represents the mean change (baseline minus six week) for the D-serine group (n = 9), Riluzole (n = 10), and Placebo group (n = 3). For consistency, all values weather positive or negative represent baseline minus week 6."|Baseline and 6-weeks|Please note that two subjects failed to complete this assessment on week 6; therefore, the total number of participants in the placebo group for CDI-S is 3.||units on a scale||Standard Error|Mean
806973|NCT01018056|Secondary|The Change From Baseline to 6-week in Scores of the DuPaul Attention Deficit Hyperactivity Disorder Rating Scale.|"DuPaul ADHD Rating Scale: The presence of ADHD symptoms will be assessed using the DSM-IV version of the ADHD rating scale developed by DuPaul. This scale has been normed in large clinical and community samples and has excellent psychometric properties including a test-retest reliability over a 2-week period of 0.93 and significant correlations with direct observations of classroom behavior. The scale has a maximum possible score of 72, and a minimum of 0. The scale ranges from 0 (the best possible outcome) to 70 (the worst possible outcome).
The data provided below represents the mean change (baseline minus six week) for the D-serine group (n = 9), Riluzole (n = 10), and Placebo group (n = 5). For consistency, all values weather positive or negative represent baseline minus week 6."|Baseline and 6 weeks|Please note that one subject failed to complete this assessment on week 6; therefore, the total number of participants in the placebo group for DuPaul ADHD is 4.||units on a scale||Standard Deviation|Mean
806974|NCT01018056|Secondary|Urine Analysis||Baseline, and at 2, 4, and 6 weeks||||||
806975|NCT01018056|Secondary|The Change From Baseline to 6-week in Plasma Amino Acid Levels|Blood testing was performed at baseline and at each clinic visit. Data shown below reflects baseline Glutamic Acid minus Week 6 Glutamic Acid, and baseline Serine minus Week 6 Serine levels; as acquired from the blood tests during these respective clinic visits.|Baseline and 6 weeks.|||micromol/L||Standard Deviation|Mean
806976|NCT01018056|Secondary|Complete Blood Count (CBC)||Screen and at 2, 4, and 6 weeks||||||
806977|NCT01018056|Secondary|Comprehensive Metabolic Panel (CMP).||Screen and at 2, 4, and 6 weeks||||||
806978|NCT01018056|Secondary|Body Weight and Physical Examination.||Screen, at Baseline, and at 2, 4, 6, and 8 weeks||||||
806979|NCT01018056|Secondary|Measurement of Vital Signs (BP, Pulse).||Screen visit, Baseline, and at 2, 4, 6, and 8 weeks||||||
806980|NCT01018056|Secondary|The Use of an Expanded Pittsburgh Side Effect Scale Modified to Include Side Effects of Riluzole and D-serine.||Baseline, and at 2, 4, 6, and 8 weeks.||||||
806981|NCT01018056|Secondary|Changes in the Children’s Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) From Baseline to 6-weeks.|"Secondary outcome for obsessive-compulsive behaviors will be measured by changes in the Children’s Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) from baseline to 6-weeks.
The severity of OCD was evaluated using either the Child Yale-Brown Obsessive Compulsive Scale (CY-BOCS) or Yale-Brown Obsessive Compulsive Scale (Y-BOCS). The (C)Y-BOCS is the most widely used instrument to assess the severity of obsessive-compulsive symptoms in research studies involving children. The (C)Y-BOCS has well established psychometric properties. The scale ranges from 0 (the best possible outcome) to 10 (the worst possible outcome).
The data provided below represents the mean change (baseline minus six week) for the D-serine group (n = 9), Riluzole (n = 10), and Placebo group (n = 5). For consistency, all values weather positive or negative represent baseline minus week 6."|Baseline and 6-weeks|||units on a scale||Standard Error|Mean
807031|NCT01018420|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that colchicine reaches in the plasma.|serial pharmacokinetic blood samples collected pre-dose and 1 (prior to second dose), 3 (prior to fourth dose), 6 (prior to final dose), 6.17, 6.33, 6.5, 6.75, 7, 7.25, 7.5, 7.75, 8, 10, 12, 23, 36, 48, 72 and 96 hours post-dose|||ng/mL||Standard Deviation|Mean
806982|NCT01018056|Secondary|The Change From Baseline to 6-week Score for the Patient Global Impression of Improvement (PGI-I).|"Patient Global Impression of Improvement (PGI-I) is a single seven point scale in which the patient/parent is asked to assess the change in overall condition ranging from “very much” improved to “very much worse.”
A score of 1 corresponds to “very much better”; 2 equals “much better;” 3 denotes “a little better”; and 4 represents “no change.” Scores above 4 are used to indicate deterioration, i.e., 5 equals “a little worse;” 6 is “much worse;” and 7 is “very much worse.”
The data provided below represents the mean change (baseline minus six week) for the D-serine group (n = 9), Riluzole (n = 10), and Placebo group (n = 5). For consistency, all values weather positive or negative represent baseline minus week 6. Please note that only summary data (mean and standard deviation per group) were intended to be reported, and not participant level data (i.e. each individual data point of every subject per group)--this applies to all outcome measures reported in the results."|Baseline and 6 weeks|||units on a scale||Standard Error|Mean
806983|NCT01018056|Secondary|The Change From Baseline to 6-week Score for the Clinical Global Impression –Improvement (CGI-I).|"Clinical Global Impression-Improvement (CGI-I): The CGI-I is used to compare current severity to baseline. A score of 1 corresponds to “very much improved”; 2 equals “much improved;” 3 denotes “minimal change”; and 4 represents “no change.” Scores above 4 are used to indicate deterioration, i.e., 5 equals “minimally worse;” 6 is “much worse;” and 7 is “very much worse.”
The data provided below represents the mean change (baseline minus six week) for the D-serine group (n = 9), Riluzole (n = 10), and Placebo group (n = 5). For consistency, all values weather positive or negative represent baseline minus week 6. Please note that summary data (mean and standard deviation per group) were intended to be reported, and not participant level data (i.e. each individual data point of every subject per group)."|Baseline and 6-weeks|||units on a scale||Standard Error|Mean
806984|NCT01018056|Secondary|The Change From Baseline to 6-week Scores for the Yale Global Tic Severity Scale (YGTSS) Total Score.|"i) Yale Global Tic Severity Scale (YGTSS): The YGTSS is a semi-structured clinical interview designed to measure current tic severity. It is comprised of two parts, a tic score (0-50) and a total impairment score (0-50), total maximum score is 100. This scale has established validity, as assessed by Dr. Walkup and colleagues and is considered the best currently available scale to rate the severity of tics. This scale ranges from 0 (the best possible outcome) to 100 (the worst possible outcome).
The data provided below represents the mean change (baseline minus six week) for the D-serine group (n = 9), Riluzole (n = 10), and Placebo group (n = 5). For consistency, all values weather positive or negative represent baseline minus week 6. Please note that summary data (mean and standard deviation per group) were intended to be reported, and not participant level data (i.e. each individual data point of every subject per group)."|Baseline and 6-weeks|||units on a scale||Standard Deviation|Mean
806985|NCT01018056|Primary|The Change From Baseline to 6-week Scores for The Total Tic Subscale (TTS)|"The primary outcome measure is effective tic suppression as determined by the difference in the Total Tic subscale (TTS) scores of the Yale Global Tic Severity Scale (YGTSS) at baseline and 6 weeks.
i) Yale Global Tic Severity Scale (YGTSS): The YGTSS is a semi-structured clinical interview designed to measure current tic severity. It is comprised of two parts, a tic score (0-50) and a total impairment score (0-50). The Total Tic Score (TTS: 0-50) has been selected as the primary outcome measure. The scale ranges from 0 (the best possible outcome) to 50 (the worst possible outcome). This scale is considered the best currently available scale to rate the severity of tics. The data provided below represents the mean change (baseline minus six week) for the D-serine group (n = 9), Riluzole (n = 10), and Placebo group (n = 5). For consistency, all values weather positive or negative represent baseline minus week 6."|Baseline and 6-weeks|||units on a scale||Standard Deviation|Mean
806986|NCT01018095|Secondary|TV Culture Positive Result|Participants who returned for their follow up visits were tested for Trichomonas vaginalis using InPouch culture. If parasites are present, it will yield a culture positive result.|3 months post-enrollment|Participants who returned for their 3 mo follow up visit||participants|||Number
806987|NCT01018095|Primary|TV Culture Positive Result|At the participants' test of cure (TOC) visits they were screened for Trichomonas vaginalis using (InPouch) culture. Presence of parasite will yield a culture positive result.|test-of-cure visit at 6-12 days post-treatment completion|Participants who returned for their test of cure visit||participants|||Number
806988|NCT01018134|Secondary|Mean Change From Baseline in %Body Surface Area (%BSA) Affected at Day 28 (or Early Termination).|"Body Surface Area (BSA) is a numerical score used to measure the physician's assessment of the percentage of the participant's total BSA involved with psoriasis.
BSA = SQRT ((height (cm) X weight (kg))/3600) BSA is in m2, W is weight in kg, and H is height in cm. Total body Surface Area (BSA) in meters squared
%Body Surface Area Affected the Rule of Nine was be used."|Day 28|The Intent-to-Treat (ITT) population was used for the secondary efficacy analysis after 28 days of treatment.||percentage of Body Surface Area Affected||Standard Deviation|Mean
806989|NCT01018134|Secondary|Mean Change From Baseline in Total Lesion Severity Score (TLSS) at Day 28|Each lesion was evaluated for 3 components: erythema, plaque elevation, and scaling. Each component was given a score using the following scale: 0=clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4=Severe, 5=Very Severe., with increasing score reflecting increased lesion severity. The TLS score is calculated as the sum of the 3 components.|Day 28|The Intent-to-Treat (ITT) population was used for the secondary efficacy analysis after 28 days of treatment.||units on a scale||Standard Deviation|Mean
806990|NCT01018134|Secondary|Mean Change From Baseline in PGA Score at Day 28 Using the ITT|Physician Global Assessment (PGA) of Psoriasis is scored based on dermatologist's assessment of disease averaged over all lesions of face, genitals, or intertriginous area (i.e., breast fold, gluteal crease, axilla). Overall lesions were graded for plaque formation, induration, erythema, and scaling; range: 0 (clear) to 5 (very severe). The severity score was summed and averaged after which the total average is rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe; 5=very severe). PGA response was defined as 0 (clear) or 1 (almost clear) Higher scores indicate greater severity of disease.|Day 28|The Intent-to-Treat (ITT) population was used for the secondary endpoint analysis.||units on a scale||Standard Deviation|Mean
807032|NCT01018511|Secondary|AUCss of Solifenacin||Week 4, Week 8 and Week 12 (collection time points: trough, 1-3 hours post dose, 4-5 hours post-dose and 7-10 hours post-dose)|"PKAS population. N indicates the number of participants with available data at each timepoint."||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
806991|NCT01018134|Primary|Number of Participants in Each Treatment Group With Treatment Success for the Target Lesion (Total Lesion Severity Scale (TLSS) a Score of 0 or 1).|"The proportion of patients in each treatment group who were considered a Treatment Success for the target lesion (a score of 0 or 1 for each of the three signs/symptoms (i.e., scaling, erythema and plaque elevation)) at Day 28.
Each component was given a score using the following scale: 0=clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4=Severe, 5=Very Severe., with increasing score reflecting increased lesion severity. The TLS score is calculated as the sum of the 3 components.
A TLS score of 0 = Clear or 1= Almost Clear was considered treatment success."|Day 28|The primary measure of efficacy was based on the ITT population. One hundred fifty (150) patients used the study medication and were included in the analysis of safety. Two patients withdrew consent and did not have end of study efficacy procedures performed and were excluded from the efficacy analysis.||percentage of Participants|||Number
806992|NCT01018134|Primary|Number of Participants in Each Treatment Group With Clinical Cure: Physician's Global Assessment (PGA) Score = 0 or 1 at Day 28|"The primary endpoint was the proportion of patients in each treatment group who were considered a Clinical Success (PGA score of 0 or 1) at Day 28 for each of the three signs/symptoms (i.e., scaling, erythema and plaque elevation)
The primary measure of efficacy was evaluated using those patients eligible for inclusion in the ITT population.
On a seven point grade PGA scale a patient will be considered a Clinical Success if: the patient's PGA score is 0 or 1.
A score of 0 = Clear or 1= Almost Clear was considered clinical success.
A patient will be considered a Clinical Failure if: the patient’s PGA score is > 1, the patient was considered to have an insufficient therapeutic response"|28 days|The primary measure of efficacy was based on the ITT population. One hundred fifty (150) patients used the study medication and were included in the analysis of safety. Two patients withdrew consent and did not have end of study efficacy procedures performed and were excluded from the efficacy analysis.||percentage of participants|||Number
806993|NCT01018186|Primary|Maximum 24 Hour Holter Heart Rate for Participants With at Least 16 Hours of Recorded Data|Twenty-four hour Holter monitors were obtained using a 12-lead Holter monitor. Holter monitor data were transmitted to a centralized vendor for analysis and interpretation by a licensed cardiologist.|0-24 hours at Screening, Day 1, Week 28, and Week 52|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||beats per minute||Standard Deviation|Mean
806994|NCT01018186|Primary|Mean 24 Hour Holter Heart Rate for Participants With at Least 16 Hours of Recorded Data|Twenty-four hour Holter monitors were obtained using a 12-lead Holter monitor. The Holter monitor is worn by the participant for 24 hours, and the monitor continuously records the heart’s rhythm while the monitor is worn. At the end of the 24 hour period, the data from the monitor are downloaded and transmitted to the centralized vendor for analysis and interpretation by a licensed cardiologist.|0-24 hours at Screening, Day 1, Week 28, and Week 52|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||beats per minute||Standard Deviation|Mean
806995|NCT01018186|Primary|Maximum Change From Baseline in the QT Interval Using Bazett’s Correction (QTcB) and QT Interval Using Fridericia’s Correction (QTcF)|The QT interval is an electrocardiogram (ECG) parameter that represents the electrical depolarization and repolarization of the left and right ventricles of the heart. The QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the ECG. Corrected QT (QTc) is the QT interval corrected for heart rate by using Bazett's formula (QTcB) and Fridericia's formula (QTcF). 12-lead ECG measurements were perfomed at the following scheduled time points: Baseline; Week 2, Week 12, Week 28, and Week 52/Early Withdrawal. The Baseline value is defined as the value taken pre-dose at screening. The maximum post-Baseline value was derived using all scheduled, unscheduled, and Early Withdrawal ECG assessments. Maximum change from Baseline was calculated as the maximum post-Baseline value minus the value at Baseline.|Baseline; Week 2, Week 12, Week 28, and Week 52/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed.||Milliseconds (msec)||Standard Deviation|Mean
806996|NCT01018186|Primary|Change From Baseline in the Logarithm of the Minimum Angle of Resolution (LogMAR) Visual Acuity at Week 28 and Week 52|Visual acuity is defined as the acuteness or clearness of vision. The minimum angle of resolution (MAR) is the angle a viewed object subtends at the eye, usually stated in degrees/minutes of arc. Visual acuity was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) charts in decimal numbers. The LogMAR scale is used to express the visual acuity in a linear scale as the logarithm to base 10 of the MAR. A lower score indicates better visual acuity; visual acuity decreases with an increasing score. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline; Week 28 and Week 52|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Scores on a scale||Standard Deviation|Mean
806997|NCT01018186|Primary|Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Nuclear Opalescence (NO) at Week 28 and Week 52|NO is the opalescence of the nucleus (central layer) of the lens. Per LOC III, NO ranges from 0.1 (clear or colorless) to 6.9 (very opaque or brunescent). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline; Week 28 and Week 52|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Scores on a scale||Standard Deviation|Mean
806998|NCT01018186|Primary|Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Nuclear Color (NC) at Week 28 and Week 52|NC is the color of the nucleus (central layer) of the lens. Per LOC III, NC ranges from 0.1 (clear or colorless) to 6.9 (very opaque or brunescent). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline; Week 28 and Week 52|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Scores on a scale||Standard Deviation|Mean
806999|NCT01018186|Primary|Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Cortical Opacity (C) at Week 28 and Week 52|C is defined as the opacification of the cortex (outer layer) of the lens. Per LOC III, C ranges from 0.1 (clear or colorless) to 5.9 (very opaque). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline; Week 28 and Week 52|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||participants|||Number
807000|NCT01018186|Primary|Change From Baseline in Horizontal Cup-to-disc Ratio at Week 28 and Week 52|Funduscopic examination was performed at Baseline, Week 28, and Week 52 to measure the horizontal cup-to-disc ratio of both eyes. The horizontal cup-to-disc ratio is the ratio of the horizontal diameter of the physiological cup to that of the horizontal diameter of the optic disc. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline; Week 28 and Week 52|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||ratio||Standard Deviation|Mean
807001|NCT01018186|Primary|Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52|Intraocular pressure (IOP) is the fluid pressure inside the eye. IOP was measured twice for each eye at Baseline, Week 28, and Week 52 using Goldmann Applanation tonometry. The second IOP reading was used for analysis. The number of participants with a change from Baseline in IOP of <0 mmHg, >=0 to <4 mmHg, >=4 to <7 mmHg, >=7 to <11 mmHg, and >=11 mmHg are presented. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline; Week 28 and Week 52|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||participants|||Number
807002|NCT01018186|Primary|Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Posterior Subcapsular Opacity (P) at Week 28 and Week 52|P is defined as the opacification at the back of the lens adjacent to the capsule (or bag) in which the lens sits. An event of P is defined as an increase of >=0.3 from Baseline in LOCS III grade for P in either eye at any time post-Baseline. Per LOC III, P ranges from 0.1 (clear or colorless) to 5.9 (very opaque). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline; Week 28, and Week 52|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||participants|||Number
807003|NCT01018186|Primary|Maximum Change From Baseline in Pulse Rate|Pulse rate was measured at the following scheduled time points: Screening, Day 1, Week 2, Week 4, Week 8, Week 12, Week 20,Week 28, Week 36, Week 44, and Week 52/Early Withdrawal. Baseline is defined as the Visit 1 (screening) value. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline. Maximum change from Baseline for any post-Baseline visit was derived using all scheduled, unscheduled, and Early Withdrawal visits.|From Baseline until Visit 11/Early Withdrawal (52 weeks)|ITT Population||Beats per minute||Standard Deviation|Mean
807004|NCT01018186|Primary|Maximum Change From Baseline in Systolic Blood Pressure (SBP) and Minimum Change From Baseline in Diastolic Blood Pressure (DBP)|SBP and DBP were measured at the following scheduled time points: Screening, Day 1, Week 2, Week 4, Week 8, Week 12, Week 20, Week 28, Week 36, Week 44, and Week 52/Early Withdrawal. Baseline is defined as the Visit 1 (screening) value. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline. Maximum and minimum change from Baseline for any post-Baseline visit was derived using all scheduled, unscheduled, and Early Withdrawal visits.|From Baseline until Visit 11/Early Withdrawal (52 weeks)|ITT Population||Millimeters of mercury (mmHg)||Standard Deviation|Mean
807005|NCT01018186|Primary|Number of Participants With Evidence of Oral Candidiasis at Any Time Post-Baseline|A detailed oropharyngeal examination was done at all clinic visits for visual/clinical evidence of oral candidiasis over the entire Treatment Period (worst case any time post-Baseline). For participants with visual/clinical evidence of candidiasis during the Treatment Phase of the study, a culture swab was taken and analyzed for infection.|From Baseline until Visit 11/Early Withdrawal (52 weeks)|ITT Population. Only those participants available at the specified time points were analyzed.||participants|||Number
807006|NCT01018186|Primary|Ratio of 24-hour Urinary Cortisol Excretion at Week 52 to Baseline|A 24-hour urine sample was collected, and the LSGM for 24-hour UCE was calculated at Baseline and at Week 52. The ratio of the Week 52 LSGM to the Baseline LSGM was calculated as the value at Week 52 divided by the value at Baseline. Analysis was performed using ANCOVA with covariates of region, sex, age, treatment, and the log of the Baseline values.|Baseline and Week 52|UC Population. Only those participants available at the specified time point were analyzed.||Ratio of LSGM of UCE to Baseline|||Number
807007|NCT01018186|Primary|Ratio of 24-hour Urinary Cortisol Excretion at Week 28 to Baseline|A 24-hour urine sample was collected, and the LSGM for 24-hour UCE was calculated at Baseline and at Week 28. The ratio of the Week 28 LSGM to the Baseline LSGM was calculated as the value at Week 28 divided by the value at Baseline. Analysis was performed using ANCOVA with covariates of region, sex, age, treatment, and the log of the Baseline values.|Baseline and Week 28|UC Population. Only those participants available at the specified time point were analyzed.||Ratio of LSGM of UCE to Baseline|||Number
807008|NCT01018186|Primary|Ratio of 24-hour Urinary Cortisol Excretion at Week 12 to Baseline|A 24-hour urine sample was collected, and the least square geometric mean (LSGM) for 24-hour urinary cortisol excretion (UCE) was calculated at Baseline and at Week 12. The ratio of the Week 12 LSGM to the Baseline LSGM was calculated as the value at Week 12 divided by the value at Baseline. Analysis was performed using analysis of covariance (ANCOVA) with covariates of region, sex, age, treatment, and the log of the Baseline values.|Baseline and Week 12|Urinary cortisol (UC) Population: participants in the ITT Population whose urine samples did not have confounding factors that affected the interpretation of results. These participants were determined prior to breaking the blind. Only those participants available at the specified time point were analyzed.||Ratio of LSGM of UCE to Baseline|||Number
807009|NCT01018186|Primary|Number of Participants With the Indicated Shift From Baseline to High, Normal or no Change, and Low Post-Baseline Values for Urinary Cortisol Excretion|"A 24-hour urine sample was collected for the measurement of 24-hour urinary cortisol excretion (UCE) at the following scheduled time points: Baseline, Week 12, Week 28, and Week 52/Early Withdrawal. Any visit post-baseline (AVPB) value was derived using laboratory assessments performed at scheduled, unscheduled, and Early Withdrawal visits. Participants who had a shift from Baseline in their post-Baseline UCE values relative to the normal range, are presented in the To high and To low categories. Participants whose post-Baseline UCE values were unchanged (e.g., High to High) or whose value became normal, are presented in the To normal or no change category. The normal range for UCE is defined as: 11 to 138 nanomoles per 24 hours (nmol/24 hr) for participants >=18 years of age, 8.3 to 151.7 nmol/24 hr for participants 14 to 17 years of age, and 2.8 to 124.2 nmol/24 hr for participants 12 and 13 years of age."|Baseline; Week 12, Week 28, and Week 52/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||participants|||Number
807010|NCT01018186|Primary|Change From Baseline in Hemoglobin at Week 12, Week 28, and Week 52/Early Withdrawal|Blood samples were collected for the measurement of hemoglobin values at the following scheduled time points: Baseline, Week 12, Week 28, and Week 52/Early Withdrawal. The Baseline value is defined as the most recent recorded value at Screening or prior to Day 1. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline; Week 12, Week 28, and Week 52/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Grams per liter (g/L)||Standard Deviation|Mean
807011|NCT01018186|Primary|Change From Baseline in Hematocrit at Week 12, Week 28, and Week 52/Early Withdrawal|Blood samples were collected for the measurement of hematocrit values at the following scheduled time points: Baseline, Week 12, Week 28, and Week 52/Early Withdrawal. The Baseline value is defined as the most recent recorded value at Screening or prior to Day 1. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline; Week 12, Week 28, and Week 52/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Proportion of 1.0||Standard Deviation|Mean
807012|NCT01018186|Primary|Change From Baseline in Eosinophil Count, Total Absolute Neutrophil Count (ANC), Platelet Count, and White Blood Cell (WBC) Count at Week 12, Week 28, and Week 52/Early Withdrawal|Blood samples were collected to determine the eosinophil count, total ANC, platelet count, and WBC count at the following scheduled time points: Baseline, Week 12, Week 28, and Week 52/Early Withdrawal. The Baseline value is defined as the most recent recorded value at Screening or prior to Day 1. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline; Week 12, Week 28, and Week 52/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||10^9 cells per liter (GI/L)||Standard Deviation|Mean
807013|NCT01018186|Primary|Change From Baseline in the Percentage of Basophils, Eosinophils, Hematocrit, Lymphocytes, Monocytes, and Segmented Neutrophils in the Blood at Week 12, Week 28, and Week 52/Early Withdrawal|Blood samples were collected for the measurement of the percentage of basophils, eosinophils, hematocrit, lymphocytes, monocytes, and segmented neutrophils in the blood at the following scheduled time points: Baseline, Week 12, Week 28, and Week 52/Early Withdrawal. The Baseline value is defined as the most recent recorded value at Screening or prior to Day 1. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline; Week 12, Week 28, and Week 52/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||Percentage||Standard Deviation|Mean
807014|NCT01018186|Primary|Change From Baseline in Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 12, Week 28, and Week 52/Early Withdrawal|Blood samples were collected for the measurement of chloride, carbon dioxide (CO2) content/bicarbonate, glucose, potassium, sodium, and urea/BUN values at the following scheduled time points: Baseline, Week 12, Week 28, and Week 52/Early Withdrawal. The Baseline value is defined as the most recent recorded value at Screening or prior to Day 1. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline; Week 12, Week 28, and Week 52/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||Millimoles per liter (mmol/L)||Standard Deviation|Mean
807015|NCT01018186|Primary|Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine at Week 12, Week 28, and Week 52/Early Withdrawal|Blood samples were collected for the measurement of direct bilirubin, indirect bilirubin, total bilirubin, and creatinine values at the following scheduled time points: Baseline, Week 12, Week 28, and Week 52/Early Withdrawal. The Baseline value is defined as the most recent recorded value at Screening or prior to Day 1. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline; Week 12, Week 28, and Week 52/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||Micromoles per liter (µmol/L)||Standard Deviation|Mean
807033|NCT01018511|Secondary|Tmaxss of Solifenacin||Week 4, Week 8 and Week 12|"PKAS population. N indicates the number of participants with available data at each timepoint."||h||Geometric Coefficient of Variation|Geometric Mean
807016|NCT01018186|Primary|Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyltransferase (GGT) at Week 12, Week 28, and Week 52/Early Withdrawal|Blood samples were collected for the measurement of ALP, ALT, AST, CK, and GGT values at the following scheduled time points: Baseline, Week 12, Week 28, and Week 52/Early Withdrawal. The Baseline value is defined as the most recent recorded value at Screening or prior to Day 1. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline; Week 12, Week 28, and Week 52/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||International units per liter (IU/L)||Standard Deviation|Mean
807017|NCT01018186|Primary|Change From Baseline in Albumin and Total Protein at Week 12, Week 28, and Week 52/Early Withdrawal|Blood samples were collected for the measurement of albumin and total protein values at the following scheduled time points: Baseline, Week 12, Week 28, and Week 52/Early Withdrawal. The Baseline value is defined as the most recent recorded value at Screening or prior to Day 1. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline; Week 12, Week 28, and Week 52/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||Grams per liter (G/L)||Standard Deviation|Mean
807018|NCT01018186|Primary|Number of Participants With Severe Asthma Exacerbations During the Treatment Period|A severe asthma exacerbation is defined as the deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. Courses of corticosteroids separated by 1 week or more were treated as separate severe exacerbations.|From the start of study medication until Visit 11 (Week 52)/Early Withdrawal|ITT Population||participants|||Number
807019|NCT01018186|Primary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During the Treatment Period|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in deciding whether reporting is appropriate in other situations. Refer to the General Adverse AE/SAE module for a complete list of AEs and SAEs.|From the start of study medication until Visit 11 (Week 52)/Early Withdrawal|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study medication||participants|||Number
807020|NCT01018264|Secondary|Number of Nocturia Episodes Per 24 Hour Period|To examine the effect of solifenacin succinate (VESIcare) on urinary incontinence severity|12 weeks|||Number of nocturia episodes per 24 hours||Standard Deviation|Mean
807021|NCT01018264|Secondary|Parkinson's Disease Quality of Life Scale (PDQOL)|This scale is used to assess quality of life in Parkinson's Disease patients. Parkinson's disease quality of life scale has a possible point range from 37 (worst outcome) to 185 (best outcome). The goal of this outcome measure is to examine the effect of solifenacin succinate (VESIcare) on quality of life.|12 weeks|||units on a scale||Standard Deviation|Mean
807022|NCT01018264|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) Total|To examine the effect of solifenacin succinate (VESIcare) on Parkinson's disease severity. The UPDRS total score ranges from 0 (no disability) to 199 (total disability).|12 weeks|||units on a scale||Standard Deviation|Mean
807023|NCT01018264|Secondary|Number of Urinary Incontinence Episodes Per 24 Hour Period|This scale it the mean number of urinary incontinence episodes per 24 hour period, as assessed by a 3-day bladder diary. The goal is to examine the effect of solifenacin succinate (VESIcare) on urinary incontinence severity.|12 weeks|||Number of incontinence episodes/24 hours||Standard Deviation|Mean
807024|NCT01018264|Primary|Number of Micturations Per 24 Hour Period|The primary objective of this study is to measure the efficacy of solifenacin succinate (VESIcare) in reducing the mean number of micturitions per 24 hour period in Parkinson’s disease (PD) patients as measured by voiding diaries.|12 weeks|||Number of micturations per 24 hours||Standard Deviation|Mean
807025|NCT01018394|Primary|Tobacco Abstinence at 12 Weeks|Number of participants who were biochemically confirmed abstinent from tobacco at week 12 using urinary anabasine less than 2 ng per ml.|week 12|||participants|||Number
807026|NCT01018394|Other Pre-specified|Smokeless Tobacco Reduction Greater or Equal to 50%|Percentage of participants who reduced smokeless tobacco use (cans per week) by 50% or more from baseline|baseline, week 4|||percentage of participants|||Number
807027|NCT01018420|Secondary|Electrocardiogram (ECG) Evaluation of the QTcF Interval (Moxifloxacin)|The QT interval assesses cardiac repolarization and risk for arrhythmias. It is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. It is dependent on heart rate and is corrected (c) to aid interpretation via Fridericia’s adjustment (F), and is reported as QTcF.|24 hours - measured 0.5 hr prior to dose (baseline), then 1, 3, 6, 7, 8, 10, 12, and 23 hours after dose|||milliseconds||Standard Deviation|Mean
807028|NCT01018420|Secondary|Electrocardiogram (ECG) Evaluation of the QTcF Interval (Colchicine)|The QT interval assesses cardiac repolarization and risk for arrhythmias. It is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. It is dependent on heart rate and is corrected (c) to aid interpretation via Fridericia’s adjustment (F), and is reported as QTcF.|24 hours - measured 0.5 hr prior to first dose (baseline), then 1, 3, 6, 7, 8, 10, 12, and 23 hours after first dose|||milliseconds||Standard Deviation|Mean
807029|NCT01018420|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|serial pharmacokinetic blood samples collected pre-dose and 1 (prior to second dose), 3 (prior to fourth dose), 6 (prior to final dose), 6.17, 6.33, 6.5, 6.75, 7, 7.25, 7.5, 7.75, 8, 10, 12, 23, 36, 48, 72 and 96 hours post-dose|||ng-hr/mL||Standard Deviation|Mean
807037|NCT01018511|Secondary|Area Under the Curve at Steady State (AUCss) of Tamsulosin||Week 4, Week 8 and Week 12 (collection time points: trough, 1-3 hours post dose, 4-5 hours post-dose and 7-10 hours post-dose)|"PKAS population. N indicates the number of participants with available data at each timepoint."||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
807038|NCT01018511|Secondary|Time of Maximum Concentration at Steady State (Tmaxss) of Tamsulosin||Week 4, Week 8 and Week 12|"PKAS population. N indicates the number of participants with available data at each timepoint."||h||Geometric Coefficient of Variation|Geometric Mean
807039|NCT01018511|Secondary|Minimum Concentration at Steady State (Cminss) of Tamsulosin||Week 4, Week 8 and Week 12|"PKAS population. N indicates the number of participants with available data at each timepoint."||ng/mL||Geometric Coefficient of Variation|Geometric Mean
807040|NCT01018511|Secondary|Maximum Concentration at Steady State (Cmaxss) of Tamsulosin||Week 4, Week 8 and Week 12|"PKAS population. N indicates the number of participants with available data at each timepoint."||ng/mL||Geometric Coefficient of Variation|Geometric Mean
807041|NCT01018511|Secondary|Apparent Clearance (CL/F) of Tamsulosin||Week 4, Week 8 and Week 12|"Pharmacokinetics Analysis Set (PKAS)- randomized participants who received at least 1 dose of double-blind study drug and had at least 1 quantifiable plasma concentration of tamsulosin OCAS and/or solifenacin. N indicates the number of participants with available data at each timepoint."||L/h||Geometric Coefficient of Variation|Geometric Mean
807042|NCT01018511|Secondary|Change From Baseline to End of Treatment in Average Flow Rate (Qmean)|Qmean during a micturition (urination) was recorded using uroflowmetry.|Baseline and Week 12|SAF population with at least one baseline and one post-baseline micturition episode.||mL/s||Standard Deviation|Mean
807043|NCT01018511|Secondary|Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax)|Qmax during a micturition (urination) was recorded using uroflowmetry.|Baseline and Week 12|SAF population with at least one baseline and one post-baseline micturition episode.||mL/s||Standard Deviation|Mean
807044|NCT01018511|Secondary|Change From Baseline to End of Treatment in Post Void Residual (PVR) Volume|PVR volume is the volume of urine retained after voiding. PVR volume was assessed by ultrasonography or bladder scan.|Baseline and Week 12|SAF population with at least one baseline and one post-baseline PVR volume measured.||mL||Standard Deviation|Mean
807045|NCT01018511|Secondary|Number of Participants With Adverse Events (AEs)|Safety is monitored by collecting AEs, which include abnormal laboratory parameters, vital signs or ECG data if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. A serious AE (SAE) was an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important. AEs were assessed by the Investigator for intensity as mild (no disruption of normal daily activities), moderate (affected normal daily activities) or severe (inability to perform daily activities) and for causal relationship to study drug. A treatment-emergent adverse event (TEAE) was defined as an AE that occurred after administration of the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug.|From first dose of double-blind study drug up to 14 days of last dose of double-blind study drug (up to 14 weeks)|Safety Analysis Set (SAF) - consisted of participants who received at least one dose of double blind study drug and for whom any data was reported after intake of the first dose of study drug.||participants|||Number
807046|NCT01018511|Secondary|Clinician Global Impression Scale at End of Treatment: Overall Bladder Symptoms|The Clinician Global Impression (CGI) is a questionnaire completed by the physician to assess change in the participants bladder symptoms since the start of the study. The questionnaire consists of 1 question with 7 response levels ranging from 1 to 7 (very much improved to very much worse).|Baseline and Week 12|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.||participants|||Number
807047|NCT01018511|Secondary|Patient Global Impression Scale at End of Treatment: General Health|The Patient Global Impression (PGI) is a global questionnaire completed by the participant to assess both the change in the participants overall condition and the change in bladder symptoms since the start of the study. The questionnaire consists of 2 questions with 7 response levels ranging from 1 to 7 (very much improved to very much worse).|Baseline and Week 12|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.||participants|||Number
807048|NCT01018511|Secondary|Patient Global Impression Scale at End of Treatment: Overall Bladder Symptoms|The Patient Global Impression (PGI) is a global questionnaire completed by the participant to assess both the change in the participants overall condition and the change in bladder symptoms since the start of the study. The questionnaire consists of 2 questions with 7 response levels ranging from 1 to 7 (very much improved to very much worse).|Baseline and Week 12|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.||participants|||Number
807049|NCT01018511|Secondary|Change From Baseline to End of Treatment in EQ-5D Visual Analogue Scale (VAS) Score|Visual Analogue Scale (VAS) is part of the EQ-5D questionnaire. The VAS is self-rated by the participant ranging from 0 to 100 (worst imaginable health state to best imaginable health state).|Baseline and Week 12|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.||units on a scale||Standard Deviation|Mean
807050|NCT01018511|Secondary|Change From Baseline to End of Treatment in EQ-5D Anxiety/Depression Score|"The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:
mobility
self-care
usual activity
pain/discomfort
anxiety/depression
Each domain has 3 response levels (1= not anxious, 2= moderately anxious, 3 = extremely anxious)."|Baseline and Week 12|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.||participants|||Number
807073|NCT01018511|Secondary|Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours|A micturition is any voluntary urination, excluding episodes of incontinence only.The mean number of micturitions per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.|Baseline and Week 12|FAS population with data available at both baseline and end of treatment. LOCF imputation was used.||micturitions||Standard Error|Least Squares Mean
807051|NCT01018511|Secondary|Change From Baseline to End of Treatment in EQ-5D Pain/Discomfort Score|"The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:
mobility
self-care
usual activity
pain/discomfort
anxiety/depression
Each domain has 3 response levels (1= no pain, 2= moderate pain, 3 = extreme pain)."|Baseline and Week 12|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.||participants|||Number
807052|NCT01018511|Secondary|Change From Baseline to End of Treatment in EQ-5D Usual Activities Score|"The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:
mobility
self-care
usual activity
pain/discomfort
anxiety/depression
Each domain has 3 response levels (1= no problem, 2= some problems, 3 = unable to perform usual activities)."|Baseline and Week 12|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.||participants|||Number
807053|NCT01018511|Secondary|Change From Baseline to End of Treatment in EQ-5D Self-care Score|"The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:
mobility
self-care
usual activity
pain/discomfort
anxiety/depression
Each domain has 3 response levels (1= no problem, 2= some problems, 3 = unable to wash/dress)."|Baseline and Week 12|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.||participants|||Number
807054|NCT01018511|Secondary|Change From Baseline to End of Treatment in EQ-5D Mobility Score|"The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:
mobility
self-care
usual activity
pain/discomfort
anxiety/depression
Each domain has 3 response levels (1= no problem, 2= some problems, 3 = confined to bed)."|Baseline and Week 12|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.||participants|||Number
807055|NCT01018511|Secondary|Percentage of Participants Who Were OAB-q Responders at End of Treatment|A OAB-q responder was defined as a participant with an improvement from baseline in HRQoL subscale total score ≥ 10.|Week 12 (end of treatment)|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.||percentage of participants|||Number
807056|NCT01018511|Secondary|Change From Baseline to End of Treatment in HRQoL Subscale: Total Score|"The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6:
coping
concern
sleep
social interaction
Total score is calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement."|Baseline and Week 12|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.||units on a scale||Standard Error|Least Squares Mean
807057|NCT01018511|Secondary|Change From Baseline to End of Treatment in HRQoL Subscale: Social Score|"The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6:
coping
concern
sleep
social interaction
Social score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement."|Baseline and Week 12|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.||units on a scale||Standard Error|Least Squares Mean
807058|NCT01018511|Secondary|Change From Baseline to End of Treatment in HRQoL Subscale: Sleep Score|"The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6:
coping
concern
sleep
social interaction
Sleep score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement."|Baseline and Week 12|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.||units on a scale||Standard Error|Least Squares Mean
807059|NCT01018511|Secondary|Change From Baseline to End of Treatment in HRQoL Subscale: Concern Score|"The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6:
coping
concern
sleep
social interaction
Concern score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement."|Baseline and Week 12|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.||units on a scale||Standard Error|Least Squares Mean
807060|NCT01018511|Secondary|Change From Baseline to End of Treatment in Health Related QoL (HRQoL) Subscale: Coping Score|"The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health–related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6:
coping
concern
sleep
social interaction
Coping score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement."|Baseline and Week 12|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.||units on a scale||Standard Error|Least Squares Mean
807788|NCT01026402|Secondary|Percent Change From Baseline in p4EBP1 at 2 Hours Post Dose|Phosphorylation levels of 4EBP1 from peripheral blood mononuclear cell (Patients with undetectable values at baseline have been excluded)|predose and 2 hours after a single dose|Efficacy analysis set||Percent change||Full Range|Median
807061|NCT01018511|Secondary|Change From Baseline to End of Treatment in Symptom Bother Score|The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health–related quality of life (HRQoL). The Symptom Bother portion consists of an 8-item scale scored from 1 to 6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from baseline indicates an improvement.|Baseline and Week 12|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.||units on a scale||Standard Error|Least Squares Mean
807062|NCT01018511|Secondary|Change From Baseline to End of Treatment in Individual IPSS Scores|"The IPSS is a validated global questionnaire to assess the degree of urinary symptoms, based on answers to 7 questions concerning urinary symptoms:
Incomplete emptying of the bladder
Intermittency
Weak stream
Hesitancy
Frequency
Urgency
Nocturia
Each question is assigned points from 0 to 5 indicating increasing severity of the symptom."|Baseline and Week 12|FAS population with the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.||units on a scale||Standard Error|Least Squares Mean
807063|NCT01018511|Secondary|Change From Baseline to End of Treatment in IPSS QoL Score|The QoL assessment was a single question asking the participant how he would feel about tolerating his current level of symptoms for the rest of his life. The answers ranged from 0 to 6 (delighted to terrible).|Baseline and Week 12|FAS population with the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.||units on a scale||Standard Error|Least Squares Mean
807064|NCT01018511|Secondary|Change From Baseline to End of Treatment in IPSS Storage Score|The IPSS is a validated global questionnaire to assess the degree of urinary symptoms based on answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The storage symptom score is the sum of the responses to 3 storage questions (frequency, urgency and nocturia) and ranges from 0 to 15 (mildly symptomatic to severely symptomatic).|Baseline and Week 12|FAS population with the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.||units on a scale||Standard Error|Least Squares Mean
807065|NCT01018511|Secondary|Change From Baseline to End of Treatment in IPSS Voiding Score|The IPSS is a validated global questionnaire to assess the degree of urinary symptoms based on answers to 7 questions. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The voiding score is the sum of the responses to 4 voiding questions (incomplete emptying of the bladder, intermittency, weak stream, hesitancy) and ranges from 0 to 20 (mildly symptomatic to severely symptomatic).|Baseline and Week 12|FAS population with the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.||units on a scale||Standard Error|Least Squares Mean
807066|NCT01018511|Secondary|Change From Baseline to End of Treatment in Mean Number of Pads Used Per 24 Hours|The mean number of pads per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.|Baseline and Week 12|FAS population and at least 1 use of a pad at baseline. LOCF imputation was used.||pads||Standard Error|Least Squares Mean
807067|NCT01018511|Secondary|Change From Baseline to End of Treatment in Mean Number of Nocturia Episodes Per 24 Hours|A nocturia episode is defined as waking up at night to void (i.e., any voiding associated with sleep disturbance between the time the participant goes to bed with the intention to sleep until the time the patient gets up in the morning with the intention to stay awake). The mean number of nocturia episodes per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.|Baseline and Week 12|FAS population and at least 1 nocturia episode at baseline. LOCF imputation was used.||nocturia episodes||Standard Error|Least Squares Mean
807068|NCT01018511|Secondary|Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours|An incontinence episode is defined as an episode with any involuntary loss of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.|Baseline and Week 12|FAS population and at least 1 incontinence episode at baseline. LOCF imputation was used.||incontinence episodes||Standard Error|Least Squares Mean
807069|NCT01018511|Secondary|Change From Baseline to End of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours|An urgency incontinence episode is defined as an episode with any involuntary leakage of urine accompanied by or immediately preceded by urgency. The mean number of urgency incontinence episodes with PPIUS grade 3 (Severe incontinence) or 4 (Urgency incontinence) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.|Baseline and Week 12|FAS population and at least 1 urgency incontinence episode at baseline. LOCF imputation was used.||urgency incontinence episodes||Standard Error|Least Squares Mean
807070|NCT01018511|Secondary|Change From Baseline to End of Treatment in Mean Number of Urgency Episodes (PPIUS Grade 3 or 4) Per 24 Hours|An urgency episode is defined as an episode of strong desire to void accompanied by fear of leakage or pain. The mean number of urgency episodes with PPIUS grade 3 (Severe urgency) or 4 (Urgency incontinence) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.|Baseline and Week 12|FAS population and at least 1 urgency episode at baseline. LOCF imputation was used.||urgency episodes||Standard Error|Least Squares Mean
807071|NCT01018511|Secondary|Change From Baseline to End of Treatment in Maximum Volume Voided Per Micturition|A micturition is any voluntary urination, excluding episodes of incontinence only. The maximum volume voided per micturition was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.|Baseline and Week 12|FAS population with data available at both baseline and end of treatment. LOCF imputation was used.||mL||Standard Error|Least Squares Mean
807072|NCT01018511|Secondary|Change From Baseline to End of Treatment in Mean Voided Volume Per Micturition|A micturition is any voluntary urination, excluding episodes of incontinence only. The mean volume voided per micturition was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.|Baseline and Week 12|FAS population with data available at both baseline and end of treatment. LOCF imputation was used.||mL||Standard Error|Least Squares Mean
807324|NCT01011868|Secondary|Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5%) After 18, 54 and 78 Weeks of Treatment|Patients that had a reduction in HbA1c of at least 0.5% from baseline to 18, 54 and 78 weeks of treatment|Baseline and 18, 54 and 78 weeks|FAS with non-completers considered failure (NCF)||participants|||Number
807074|NCT01018511|Primary|Change From Baseline to End of Treatment in Total Urgency Frequency Score (TUFS, Previously Known as Total Urgency Score [TUS])|"The Patient Perception of the Intensity of Urgency Scale (PPIUS) is a validated scale completed as part of the micturition diary. For each micturition and/or incontinence episode, the participant rated the degree of associated urgency according to the following 5-point categorical scale:
0. No urgency;
1. Mild urgency;
2. Moderate urgency;
3. Severe urgency;
4. Urgency incontinence
TUFS was calculated as the sum of the PPIUS gradings from the 3-day diary divided by the number of days on which urgency grading was recorded. Higher scores indicate more severe urgency."|Baseline and Week 12|FAS population. LOCF imputation was used.||units on a scale||Standard Error|Least Squares Mean
807075|NCT01018511|Primary|Change From Baseline to End of Treatment in Total International Prostate Symptom Score|"The International Prostate Symptom Score (IPSS) is a validated global questionnaire to assess the degree of urinary symptoms, based on answers to 7 questions concerning urinary symptoms:
Incomplete emptying of the bladder
Intermittency
Weak stream
Hesitancy
Frequency
Urgency
Nocturia
Each question is assigned points from 0 to 5 indicating increasing severity of the symptom. Total score can range from 0 to 35 (mildly symptomatic to severely symptomatic)."|Baseline and Week 12|Full Analysis Set (FAS)-participants who received at least 1 dose of double-blind study drug and had either a total IPSS or TUS at baseline and at least 1 postbaseline total IPSS or TUS. Excluded 5 participants with invalid questionnaires. Last Observation Carried Forward (LOCF) imputation was used.||units on a scale||Standard Error|Least Squares Mean
807076|NCT01018680|Other Pre-specified|Percentage of Participants With a Change of Better, Worse, or No Change in Health Outcomes as Measured by Resource Utilization (REU) up to 10 Weeks|"REU captures information regarding the participant’s work status and/or health care utilization. Investigators gather information from medical records, psychiatric history, and direct questioning of the participant and his or her family to complete the questionnaire. Responses to each item, comparing baseline to endpoint, are characterized as Better, Same, or Worse. Better: an increase in time spent working/volunteering/holding a job, decrease in number of health care visits; Same: no change in time spent working/volunteering/holding a job, no change in number of health care visits; Worse: decrease in time spent working/volunteering/holding a job, increase in number of health care visits."|Up to 10 weeks|Intent-to-treat (ITT) participants with a baseline and at least 1 post-baseline REU value, last-observation-carried forward (LOCF) were included in the analysis.||percentage of participants|||Number
807077|NCT01018680|Other Pre-specified|Percentage of Participants With Abnormal Pulse Rate up to 10 Weeks|Abnormal pulse rate (tachycardia) is defined as a sitting heart rate (HR) ≥ 100 beats per minute (bpm) that is also ≥ 10 bpm compared to baseline, at last visit if highest baseline HR < 100 bpm.|Up to 10 weeks|Participants with a normal baseline and at least 1 post-baseline pulse rate value, last-observation-carried forward (LOCF) were included in the analysis.||percentage of participants|||Number
807078|NCT01018680|Other Pre-specified|Percentage of Participants With Abnormal Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) up to 10 Weeks|"Abnormal DPB (diastolic hypertension) is defined as sitting DBP ≥ 90 mm Hg that is also ≥ 10 mm Hg increase from baseline that is observed at last visit if highest baseline DBP < 90 mm Hg.
Abnormal SBP (systolic hypertension) is defined as sitting SBP ≥ 140 mm Hg that is also ≥ 10 mm Hg increase from baseline that is observed at last visit if highest baseline SBP < 140 mm Hg."|Up to 10 weeks|Participants with a normal baseline and at least 1 post-baseline DBP and SBP value, last-observation-carried forward (LOCF) were included in the analysis. Participants with a normal baseline value and a nonmissing endpoint value for the variable of interest were included in the analysis.||percentage of participants|||Number
807079|NCT01018680|Secondary|Percentage of Participants Who Discontinued Due to an Adverse Event During the 10-Week Treatment Period||Baseline through 10 weeks|All randomized participants were included in the analysis.||percentage of participants|||Number
807080|NCT01018680|Other Pre-specified|Percentage of Participants With Abnormal Weight Gain and Weight Loss up to 10 Weeks|"Abnormal weight gain (potentially clinically significant [PCS] weight gain) is defined as weight gain at last visit ≥ 7% of the baseline weight.
Abnormal weight loss (PCS weight loss) is defined as weight loss at last visit ≥ 7% of the baseline weight."|Up to 10 weeks|Participants with a baseline and at least 1 post-baseline weight value, last-observation-carried forward (LOCF) were included in the analysis.||percentage of participants|||Number
807081|NCT01018680|Other Pre-specified|Percentage of Participants With Abnormal High Hemoglobin A1c (HbA1c) up to 10 Weeks|Abnormal high HbA1c is defined as a post-baseline HbA1c > 6.1% if baseline HbA1c ≤ 6.1% for lab samples obtained before November 17, 2010 and post-baseline HbA1c > 6.4% if baseline HbA1c ≤ 6.4% for lab samples obtained November 17, 2010 and beyond.|Up to 10 weeks|Number of participants with a normal baseline and at least 1 post-baseline abnormal HbA1C value, last-observation-carried forward (LOCF) were included in the analysis.||percentage of participants|||Number
807082|NCT01018680|Secondary|Percentage of Participants Who Achieved a 30 Percent or 50 Percent Reduction in the Brief Pain Inventory-Severity (BPI-S) Average Pain Score up to 8 Weeks|Response is a dichotomous outcome (Yes/No) indicating at least 30% (or 50%) reduction from baseline to endpoint for BPI-S average pain rating. The BPI-S self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Up to 8 weeks (blinded endpoint)|Modified intent to treat (mITT) population: ITT participants with a baseline and at least 1 post-baseline BPI-S average pain value, last-observation-carried forward (LOCF) were included in the analysis.||percentage of participants|||Number
807083|NCT01018680|Secondary|Percentage of Participants Who Achieved a 30 Percent or 50 Percent Reduction in the Weekly Mean of the 24-Hour Average Pain Score up to 8 Weeks|"Response is a dichotomous outcome (Yes/No) indicating at least 30% (or 50%) reduction from baseline to endpoint for the weekly mean of the 24-hour average pain ratings. The weekly mean 24-hour average pain score was calculated from the participant's daily 24-hour average pain rating assessed on an 11-point numeric rating scale, with scores from 0 (no pain) to 10 (worst possible pain)."|Up to 8 weeks (blinded endpoint)|Modified intent to treat (mITT) population: ITT participants with a baseline and at least 1 post-baseline weekly mean of the 24-hour average pain score value, last-observation-carried forward (LOCF) were included in the analysis.||percentage of participants|||Number
808061|NCT01019694|Secondary|Physician's Global Evaluation at Week 24|"Physicians evaluated the patient's overall clinical condition on a scale ranging from poor (score 1 or 2) to excellent (score 7 or 8)."|24 weeks|Treated Set is defined as all patients who were randomized and received study drug||unit on a scale||Standard Error|Least Squares Mean
807084|NCT01018680|Secondary|Percentage of Responders as Assessed by the Osteoarthritis Research Society International (OARSI) Response Criteria up to 8 Weeks|OARSI response is composite Yes/No response assessed at 8 weeks based on decrease in 24-hour average pain ratings, range: 0 (“no pain”) to 10 (“worst possible pain”), improvement in functioning (using WOMAC physical function scores, range: 0 [no difficulty] to 68 [extreme difficulty]), and improvement in participant's impression of illness (using PGAI scores, range: 0 to 10; 10=greatest severity). OARSI responder=large response in pain or function components (50% relative and 20% absolute improvement), or moderate response (20% relative and 10% absolute improvement) in 2 of 3 components.|Up to 8 weeks (blinded endpoint)|Modified intent to treat (mITT) population: ITT participants with a baseline and at least 1 post-baseline OARSI response value, last-observation-carried forward (LOCF) based on values of each of the 3 components listed in the outcome measure description were included in the analysis.||percentage of responders|||Number
807085|NCT01018680|Secondary|Percentage of Participants Using Acetaminophen Weekly During the 10-Week Treatment Period|The Least Squares (LS) Mean percentage estimates of participants using acetaminophen was determined during each week individually over the full 10-week treatment period based on participant’s daily Yes/No assessments for the use of acetaminophen. The LS Mean estimates for the main effect of treatment (average weekly use) were adjusted for baseline value, treatment, investigator (pooled), week, and treatment*week.|Baseline through 10 weeks (blinded endpoint)|Modified intent to treat (mITT) population: ITT participants with a baseline and at least 1 post-baseline weekly acetaminophen use value were included in the analysis.||percentage of participants||Standard Error|Least Squares Mean
807086|NCT01018680|Secondary|Change From Baseline in the Profile of Mood States-Brief Form (BPOMS) Total and Subscale Scores at 8 Weeks|30-item BPOMS measures positive and negative aspects of mood states (item score: 0=not at all to 4=extremely). 5 negative factors: tension-anxiety, depression-dejection, anger-hostility, fatigue-inertia, confusion-bewilderment; 1 positive factor: vigor-activity. Factor scores range: 0 to 20; high scores=negative mood (positive mood for vigor). Total score=sum of 5 negative factor scores minus vigor score; range: -20=least disturbed to 100=most disturbed. Least Squares Mean estimates adjusted for baseline value, treatment, investigator (pooled), visit, treatment*visit, and baseline value*visit.|Baseline, 8 weeks (blinded endpoint)|Modified intent to treat (mITT) population: ITT participants with a baseline and at least 1 post-baseline BPOMS value were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
807087|NCT01018680|Secondary|Change From Baseline in the Patient Global Assessment of Illness (PGAI) at 8 Weeks|The PGAI is a participant-rated measure of the severity of osteoarthritis (OA) of the knee the participant has experienced in the past week as indicated on an 11-point numeric rating scale, with scores ranging from 0 to 10, where greater numbers reflect greater severity. The Least Squares Mean estimates were adjusted for baseline value, treatment, investigator (pooled), visit, treatment*visit, and baseline*visit.|Baseline, 8 weeks (blinded endpoint)|Modified intent to treat (mITT) population: ITT participants with a baseline and at least 1 post-baseline PGAI value were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
807088|NCT01018680|Secondary|Change From Baseline in the Clinical Global Impression of Severity (CGI-S) at 8 Weeks|The CGI-S scale evaluates the severity of illness at the time of assessment. The scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). The CGI-S must be administered by a study physician in the presence of the participant or after having been in the presence of the participant. The Least Squares Mean estimates were adjusted for baseline, treatment, investigator (pooled), visit, treatment*visit, and baseline*visit.|Baseline, 8 weeks (blinded endpoint)|Modified intent to treat (mITT) population: ITT participants with a baseline and at least 1 post-baseline CGI-S value were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
807089|NCT01018680|Secondary|Change From Baseline in the Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) Scores at 8 Weeks|Measures pain severity and pain interference with function. Severity scores: 0 (no pain) to 10 (severe pain) on each question. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Mean interference is the average across the 7 interference items. The Least Squares Mean estimates were adjusted for baseline value, treatment, investigator (pooled), visit, treatment*visit, and baseline*visit.|Baseline, 8 weeks (blinded endpoint)|Modified intent to treat (mITT) population: ITT participants with a baseline and at least 1 post-baseline BPI-S/BPI-I value were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
807090|NCT01018680|Secondary|Change From Baseline in the Weekly Mean of the 24-Hour Night Pain and Worst Pain Scores at 8 Weeks|Weekly mean 24-hour night pain and worst pain values are calculated from the participant’s daily assessments of pain at night and worst pain during the previous 24 hours on an 11-point numeric rating scale, with scores from 0 (indicating “no pain”) to 10 (indicating “the worst possible pain”). The Least Squares Mean estimates were adjusted for baseline value, treatment, investigator (pooled), week, treatment*week, and baseline*week.|Baseline, 8 weeks (blinded endpoint)|Modified intent to treat (mITT) population: ITT participants with a baseline night/worst pain value and at least 1 post-baseline weekly mean 24-hour night/worst pain value were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
807091|NCT01018680|Secondary|Change From Baseline in the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) Pain, Stiffness, and Physical Function Subscale Scores at 8 Weeks|Self-administered questionnaire captures elements of pain, stiffness, and physical disability in participants with osteoarthritis of the knee and/or hip. Index has 24 questions (5 on pain, 2 on stiffness, 17 on physical function). Each question uses a 5-point numeric rating scale ranging from 0 (none) to 4 (extreme). Pain scores range: 0 to 20. Stiffness scores range: 0 to 8. Physical function scores range: 0 to 68. Higher scores=greater impairment. Least Squares Mean estimates were adjusted for baseline value, treatment, investigator (pooled), visit, treatment*visit, and baseline value*visit.|Baseline, 8 weeks (blinded endpoint)|Modified intent to treat (mITT) population: ITT participants with a baseline and at least 1 post-baseline WOMAC value were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
808011|NCT01028300|Secondary|Time to Return to Active Duty||24 months|Study was terminated early due to slow enrollment. 1 subject was enrolled but not treated due to study termination. 1 subject was enrolled and treated, but had no follow-up visits due to study termination. Only Two subjects were seen for follow-up visits, and only at 3 months post surgery.|||||
807092|NCT01018680|Secondary|Patient Global Impression of Improvement (PGI-I) at 8 Weeks|A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). The Least Squares Mean estimates were adjusted for baseline value of Patient Global Impression of Severity (PGI-S), treatment, investigator (pooled), visit, and treatment*visit. The PGI-S measures participant's perception of severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (extremely ill).|8 weeks (blinded endpoint)|Modified intent to treat (mITT) population: ITT participants with a baseline PGI-S rating and at least 1 post-baseline PGI-I rating were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
807093|NCT01018680|Primary|Change From Baseline in the Weekly Mean of the 24-Hour Average Pain Score at 8 Weeks|The weekly mean 24-hour average pain score was calculated from the participant's daily 24-hour average pain ratings using an 11-point numeric rating scale, with scores from 0 (indicating “no pain”) to 10 (indicating “the worst possible pain”). The Least Squares Mean estimates were adjusted for baseline, treatment, investigator (pooled), week, treatment*week, and baseline*week.|Baseline, 8 weeks (blinded endpoint)|Modified intent to treat (mITT) population: ITT participants with a baseline and at least 1 post-baseline weekly mean 24-hour average pain value were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
807094|NCT01018732|Secondary|Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination|Local and systemic reactions were solicited to assess safety and tolerability of vaccination|Up to Day 7|||participants|||Number
807095|NCT01018732|Secondary|Percentage of Subjects With hSBA Seroresponse After Booster Vaccination|For a subject with hSBA titer <4 at baseline, seroresponse is defined as a postvaccination hSBA titer >=8; and for a subject with hSBA titer >=4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y.|Day 8, Day 29 (5 years after primary vaccination)|Full analysis set||Percentage of participants||95% Confidence Interval|Number
807096|NCT01018732|Secondary|Geometric Mean Ratio After Booster Vaccination|Ratios are expressed as geometric mean titer at Day 8: Day 1 and at Day 29:Day 1|Day 8 and Day 29 (at 5 Years After Primary Vaccination)|full analysis set||Geometric mean ratio||95% Confidence Interval|Mean
807097|NCT01018732|Secondary|Percentage of Participants With Serum Bactericidal Activity >=8 After Booster Vaccination|Immunogenicity was measured by serum bactericidal assay with human complement (hSBA) >= 8 in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y.|Day 7, Day 28 post booster (5 years after primary vaccination)|Full Analysis set||Percentage of participants||95% Confidence Interval|Number
807098|NCT01018732|Secondary|Percentage of Participants With Serum Bactericidal Activity >=4 After Booster Vaccination|Immunogenicity was measured by serum bactericidal assay with human complement (hSBA) >= 4 in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y.|Day 7, Day 28 post booster (5 years after primary vaccination)|Full Analysis set||Percentage of participants||95% Confidence Interval|Number
807099|NCT01018732|Secondary|Geometric Mean Titer at 5 Years After Primary Vaccination|Persistence was measured by serum bactericidal assay with human complement(hSBA) and expressed as hSBA GMT in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y|Day 1 (5 years after primary vaccination )|Full analysis set||Titer||95% Confidence Interval|Geometric Mean
807100|NCT01018732|Secondary|Percentage of Participants With Serum Bactericidal Activity >=4 at 5 Years After Primary Vaccination|Persistence was measured by percentage of subjects with serum bactericidal activity with human complement (hSBA) >= 4 in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y|Day 1 (5 years after primary vaccination )|Full analysis set||Percentage of participants||95% Confidence Interval|Number
807101|NCT01018732|Primary|Geometric Mean Titer After Booster Vaccination|Immunogenicity was measured by serum bactericidal assay with human complement (hSBA) and reported as hSBA Geometric mean titer (GMT) in previously vaccinated subjects and in age-matched meningococcal vaccine-naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y|Day 8, Day 29 (5 years after primary vaccination)|Full analysis set||Titer||95% Confidence Interval|Geometric Mean
807102|NCT01018732|Primary|Percentage of Participants With Serum Bactericidal Activity >=8 at 5 Years After Primary Vaccination|Persistence of antibody response was measured by the percentage of subjects who showed a serum bactericidal activity with human complement(hSBA) >= 8 [i.e. percentage of subjects with hsBA titer >=8] in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y|Day 1 (5 years after primary vaccination)|Full analysis set (all subjects who had no major protocol violation as defined prior to database lock).||Percentage of participants||95% Confidence Interval|Number
807103|NCT01009762|Secondary|Numbers of Participants With Lowering of HIV RNA Viral-load|"HIV-1 RNA Viral load was measured by Quantitative-PCR in plasma as numbers of virus RNA copies/mm^3 relative to baseline viral-load for each participant. The numbers of participant with lowering of HIV RNA plasma Viral-load is counted at base-line and at 6 months (end of study) and provided in the table (analysis population description) and the number of participants that showed lowering of viral-load was counted.
Criteria for this anticipated end-point was a significant lowering of HIV RNA viral-load in >50% of responders (defined as participants with new T-cell responses)."|up to 6 months after treatment stop|the numbers of participants that showed changes (lowering of) in Viral load (measured as HIV-1 RNA copies/mm^3 plasma in commercial quantitative PCR) at end of study (6 months after vaccination) relative to base-line viral-load was counted at 6 month after vaccination (end of study)||participants|||Number
807130|NCT01010061|Secondary|Time to Re-Treatment/New-antileukemic Therapy|Time to re-treatment/new anti-leukemic therapy was defined as time between the date of randomization and the date of first intake of re-treatment or new anti-leukemic therapy.|Randomization to clinical cutoff (median observation 42 months)|Intent-to-treat population included all randomized participants. Participants without events (re-treatment or new anti-leukemic therapy) were censored.||Months||95% Confidence Interval|Median
808031|NCT01019135|Secondary|Exercise Capacity|Exercise capacity as measured by VO2peak on a graded stress test.|6 months|Participants with available data for exercise capacity||mL/(kg·min)||Standard Deviation|Mean
807104|NCT01009762|Secondary|Number of Participants With New T Cell Response to the Vaccine Target Epitopes|"Number of Participants with New T Cell Response to the Vaccine Target Epitopes as Measured by Intracellular Cytokine Stain Flowcytometry (IC-FACS) and/or IFNg-ELISPOT Analysis.
Criteria's for meeting anticipated secondary end-point was that >50% of vaccinees reacted with new Clusters of differentiation 8 (CD8) T-cell and/or Clusters of differentiation 4 (CD4) T-cell response to al least one of the vaccine target epitopes as measured by IC-Facs and/or interferon-gamma (IFNg) - Enzyme-Linked ImmunoSpot (ELISPOT) assays."|10-14 days or 3 months or 6 months after last immunisation|Peripheral Blood Mononuclear Cells (PBMC) from blood was measured in IFNg-ELISPOT and/or Intracellular Cytokines (ICS) Flowcytometry for T cell responses. All 10 vaccinee developed a new T cell immune response to at least one vaccine epitope. The saline placebo did not develop any new t cell responses.||participants|||Number
807105|NCT01009762|Primary|Numbers of Treatment Related Side Effects (DLT = Reaction 3 or More)|the numbers of treatment related side effects (DLT = reaction 3 or more) are registered for participants|up to 6 months after end of treatment|Interview, questionaire, objective examination by medical doctor, blood testing for hematology, clinical chemistry, CD4 counts, HIV-1 viral load||side effects|||Number
807106|NCT01009840|Secondary|Percentage of Participants With Hepatic Veno-Occlusive Disease Based on Baltimore Criteria|The Baltimore criteria for veno-occlusive disease was defined as the development of hyperbilirubinemia with serum bilirubin > 2 mg/dl within 21 days after transplantation and at least 2 of the following clinical signs and symptoms: (1) hepatomegaly, usually painful, (2) > 5% weight gain, or (3) ascites.|6 Months|Safety population included all participants who received IV busulfan.||Percentage of participants|||Number
807107|NCT01009840|Secondary|Percentage of Participants With Transplant-Related Mortality|The percentage of participants with death related to transplant.|6 Months|Safety population included all participants who received IV busulfan.||Percentage of participants|||Number
807108|NCT01009840|Secondary|Percent Difference Between Area Under Curve (AUC) and Target AUC|A test dose of IV busulfan 0.8 mg/kg was infused at Baseline (Day −12 to −9) to verify a target busulfan integrated AUC of 20,000 μM*min with a range of 16,000 to 24,000. If necessary the dose could be adjusted. The PK-directed dose recommendation based on the test dose was administered at Day -5. Blood samples for PK analysis were collected at 0, 15, 30 minutes after the End of Infusion and 240, 300, 360 minutes after start of the infusion. GC-MS was used to determine the busulfan level in plasma. The percent difference was calculated between AUC and the Target AUC.|Baseline (Day -12 to -9), Day -5|Intent-to-treat population included all participants who received the PK-directed IV busulfan followed by autologous HSCT.||Percent difference||Full Range|Median
807109|NCT01009840|Secondary|Ratio Area Under Curve (AUC)/Target AUC|A test dose of IV busulfan 0.8 mg/kg was infused at Baseline (Day −12 to −9) to verify a target busulfan integrated AUC of 20,000 μM*min with a range of 16,000 to 24,000. If necessary the dose could be adjusted. The PK-directed dose recommendation based on the test dose was administered at Day -5. Blood samples for PK analysis were collected at 0, 15, 30 minutes after the End of Infusion and 240, 300, 360 minutes after start of the infusion. Gas chromatography with mass selective detection (GC-MS) was used to determine the busulfan level in plasma. The ratio was calculated: AUC/Target AUC.|Baseline (Day -12 to -9), Day -5|Intent-to-treat population included all participants who received the PK-directed IV busulfan followed by autologous HSCT.||Ratio||Full Range|Median
807110|NCT01009840|Secondary|Percent Change in IV Busulfan Dose|The percent change in dose is relative to the busulfan dose administered at the Baseline Visit (Day -12 to -9) when a dose of 0.8 mg/kg was administered and on Day −5 when the Seattle Cancer Care Alliance recommended PK-adjusted dose was administered.|Baseline (Day -12 to -9), Day -5|Intent-to-treat population included all participants who received the PK-directed IV busulfan followed by autologous HSCT.||Percent change||Full Range|Median
807111|NCT01009840|Secondary|Percentage of Participants With Progression-free Survival Events|Progression-free survival events are death or first recurrence of progressive disease by International Myeloma Working Group Criteria.|6 Months|Intent-to-treat population included all participants who received the PK-directed IV busulfan followed by autologous HSCT.||Percentage of participants|||Number
807112|NCT01009840|Secondary|Progression-free Survival|Progression-free Survival (PFS) defined as the time from transplantation to the occurrence of the event that was death or first recurrence of progressive disease (PD) by IMWG criteria. PD was defined as an Increase of ≥25% from the lowest response value in any one or more of the following: 1)Serum M-component and/or (the absolute increase must be ≥0.5 g/dL), 2)Urine M-component and/or (the absolute increase must be ≥200 mg/24 hr), 3)In patients without measurable serum and urine M-protein levels; the difference between involved and uninvolved FLC levels. The absolute increase must be >10 mg/dL, 4)Bone marrow plasma cell percentage; the absolute percentage must be ≥10%, 5)Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas and/or 6)Development of hypercalcaemia that can be attributed solely to the plasma cell proliferative diso|6 Months|Intent-to-treat population included all participants who received the PK-directed IV busulfan followed by autologous HSCT.||Days||95% Confidence Interval|Median
807113|NCT01009840|Secondary|Percentage of Participants With Overall Survival Events|Overall Survival Event was death.|6 Months|Intent-to-treat population included all participants who received the PK-directed IV busulfan followed by autologous HSCT.||Percentage of participants|||Number
807114|NCT01009840|Secondary|Overall Survival|Overall Survival was defined as the time in days from transplantation to death due to all causes.|6 Months|Intent-to-treat population included all participants who received the PK-directed IV busulfan followed by autologous HSCT.||Days||95% Confidence Interval|Median
807139|NCT01010061|Primary|Percentage of Participants With Progression Free Survival Events|Percentage of Participants with Progression Free Survival Events: disease progression, relapse, or death.|Randomization to clinical cutoff (median observation 42 months)|Intent-to-treat population included all randomized participants.||Percentage of participants|||Number
807156|NCT01010230|Primary|Percent Change in Total Bone Mineral Content (BMC) Per Height Compared Between Intervention and Placebo Groups|Since this is considered a “pilot study” we did not adjust for multiple comparisons. These % changes were treated as continuous variables and analyzed using two way ANOVAs adjusting for stratification.|Baseline and 12 months after start of intervention|This was an intent to treat analysis.||% change in grams/cm||Standard Deviation|Mean
808032|NCT01019135|Primary|CR Program Adherence||6 months|Participants with available data for adherence||percentage of sessions attended||Standard Deviation|Mean
807115|NCT01009840|Primary|Percentage of Participants With Overall Disease Response at Month 6|The percentage of participants reported in each disease category by International Myeloma Working Group (IMWG) uniform response criteria for Multiple Myeloma 6 months after autologous Hematopoietic stem cell transplant. Overall Disease Response categories were: [stringent Complete Response (sCR)=CR + normal Free Light Chain (FLC) ratio + absence of clonal cells in bone marrow], [Complete Response (CR)=Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in bone marrow], [Very Good Partial Response (VGPR)=Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein + urine M-protein level <100 mg/24 hour], [Partial Response (PR)=≥50% reduction of serum M-protein and reduction in 24 hour urine M-protein by ≥90% or to <200 mg per 24 hour], [Stable Disease (SD)=Not meeting criteria for CR, VGPR, PR or progressive disease] or [Progressive Disease (PD)].|6 Months|Intent-to-treat population included all participants who received the PK-directed IV busulfan followed by autologous HSCT.||Percentage of participants|||Number
807116|NCT01009931|Secondary|Effects of Treatment on Immunophenotype, Signaling Profile, and Nuclear NF-kB Expression|Cycle 1 of treatment|48 months|The study participant died before the study data collection completed.|||||
807117|NCT01009931|Primary|Grade 3 and 4 Non-hematologic Treatment-related Toxicity Rates < 25%||43 months|The study participant died before the study data collection completed.|||||
807118|NCT01009931|Primary|Response Rate > 20% for 12-O-tetradecanoylphorbol-13- Acetate (TPA)+ Dexamethasone + Choline Magnesium Trisalicylate(Trilisate)||42 months|The study participant died before the study data collection completed.|||||
807119|NCT01009983|Secondary|Expression of EGFR and Other Protein Markers||baseline||||||
807120|NCT01009983|Secondary|Survival||monthly||||||
807121|NCT01009983|Secondary|Time to Progression||monthly||||||
807122|NCT01009983|Secondary|Toxicity According to CTCAE v3.0||monthly||||||
807123|NCT01009983|Primary|Antitumor Activity as Assessed by Objective Tumor Response According to RECIST Criteria|Complete or Partial response as defined by reduction in tumor size according to RECIST (Response Evaluation Criteria In Solid Tumors) rules.|every 28 days for a minimum of 84 days|||participants|||Number
807124|NCT01010009|Primary|Modulation of Deoxygenated Levels of Haemoglobin|This outcome measure provides the change from baseline values (in µmol/L) of levels of deoxygenated haemoglobin during the 46-81 min post dose testing period. This was measured in the frontal cortex by near infrared spectroscopy (NIRS).|0-81 mins (absorption period=1- 45 mins , post dose period 46- 81 mins)|NIRS data was analysed for all participants who completed the trial and who were not noted as having significantly high or low readings during data collection.||µmol/L||Standard Error|Mean
807125|NCT01010009|Secondary|Number of Participants With Significant Modulation of Cognitive Performance|This outcome measure assessed any significant modulation of cognitive task performance during the 46-81 min post dose period. The cognitive tasks utilized were cognitively demanding computer based, numerical tasks which assessed working memory. Significant modulation is defined as significant difference between baseline and post-dose task performance.|46-81 mins post dose|Cognitive performance data was analysed for all subjects who completed the trial. If data was not utilized in the final analysis then this was either due to technical issues (i.e. the computer did not save data) or it was clear that the participant had not engaged with the task/s.||Participants|||Number
807126|NCT01010009|Primary|Modulation of Levels of Total Haemoglobin|This outcome measure provides the change from baseline values (in µmol/L) of total levels of haemoglobin during the 46-81 min post dose testing period. This was measured in the frontal cortex by near infrared spectroscopy (NIRS).|0-81 mins (absorption period=1- 45 mins , post dose period 46- 81 mins)|NIRS data was analysed for all participants who completed the trial and who were not noted as having significantly high or low readings during data collection.||µmol/L||Standard Error|Mean
807127|NCT01010061|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-CLL16 Questionnaire Score|EORTC Quality of Life Questionnaire (QLQ-CLL16) module was used to assess patient-reported outcomes and symptom burden. The QLQ-CLL16 module includes three multi-item scales assessing fatigue (2 items), treatment side effects and disease symptoms (8 items), infection (4 items) and two single item scales on social activities and future health worries. Final scores are transformed such that they range from 0 − 100, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms, with changes of 5 − 10 points considered to be of minimally important difference to participants. A positive change from Baseline indicated improvement.|Baseline and Cycle 4 Day 1 (Cy4D1)|ITT population. Here, n signifies the number of participants who were evaluated for specified categories.||unit on a scale||Standard Deviation|Mean
807128|NCT01010061|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire Score|The EORTC Quality of Life Questionnaire QLQ-C30 was used to assess patient-reported outcomes (PRO) and symptom burden. The QLQ-C30 contains 30 items including the functional scales of physical functioning (5 items), role functioning (2 items), emotional functioning (4 items), cognitive functioning (2 items), social functioning (2 items) and symptom scales including fatigue (3 items), nausea and vomiting (2 items), and pain (4 items) and six single item scales on dyspnea, sleep disturbance, appetite loss, constipation, diarrhea and financial impact. Final scores are transformed such that they range from 0 − 100, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms, with changes of 5 − 10 points considered to be of minimally important difference to participants. A positive change from Baseline indicated improvement.|Baseline and Cycle 4 Day 1 (Cy4D1)|ITT population. Here, n signifies the number of participants who were evaluated for specified categories.||unit on a scale||Standard Deviation|Mean
807129|NCT01010061|Secondary|Pharmacokinetics of Obinutuzumab (RO5072759) in Combination With Chlorambucil (Clb)|Blood samples were collected from all patients allocated to the GClb treatment arm pre- and post-dose Day 1 of Cycles 1 to 6 and were sent to a laboratory. The concentration of obinutzumab in serum was determined using a validated enzyme-linked immunosorbent assay (ELISA) and was reported in micrograms/milliliter (μg/mL).|Pre- and post-dose sampling on day 1 of cycles 1-6 (Up to 26.8 months)|PK population includes all participants with PK data available at the given time-point.||μg/mL||Geometric Coefficient of Variation|Geometric Mean
808117|NCT01020123|Secondary|Sodium; Change From Baseline|Summary statistic of change from baseline|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 215 in CSR)||mEq/L||Standard Deviation|Mean
807131|NCT01010061|Secondary|Percentage of Participants With Molecular Remission at the End of Treatment|Molecular remission was defined as a minimal residual disease (MRD)-negative result at the end of treatment (assessment that occurred between 56 days and 6 months of last treatment). Molecular remission was assessed for all patients using a blood sample. Additionally, a bone marrow sample was obtained from patients whom the investigator assumed to have a complete response, consistent with the IWCLL guidelines. A combined analysis of blood and bone marrow results was conducted. A patient was considered MRD negative if result was less than 1 chronic lymphocytic leukemia (CLL) cell in 10000 leukocytes (MRD value < 0.0001) based on the method of allele specific polymerase chain reaction (ASO-PCR).|Randomization to clinical cutoff (42 months)|Participants from the Intent-to-treat population (all randomized participants) with data available for analysis. Participants who did not reach the 3 month Follow-up visit at the time of the clinical cutoff are excluded.||Percentage of participants||95% Confidence Interval|Number
807132|NCT01010061|Secondary|Duration of Response|Duration of Response was defined as the date the response [either Complete Response (CR) or Partial Response (PR)] was first recorded until the date of Disease Progression or death due to any cause. Response was assessed according IWCLL guidelines.|Randomization to clinical cutoff (median observation 42 months)|Participants from the Intent-to-treat population (all randomized participants) with CR or PR. Participants without response were censored.||Months||95% Confidence Interval|Median
807133|NCT01010061|Secondary|Overall Survival|Overall Survival (OS) was defined as the time between the date of randomization and the date of death due to any cause.|Randomization to clinical cutoff (median observation 42 months)|Intent-to-treat population included all randomized participants. Patients without OS events were censored.||Months||95% Confidence Interval|Median
807134|NCT01010061|Secondary|Event Free Survival|Event-free survival (EFS) was defined as the time between date of randomization and the date of disease progression/relapse, death, or start of a new anti-leukemic therapy. Progressive disease as per IWCLL criteria required at least one of the following: ≥50% increase in the absolute number of lymphocytes, appearance of new palpable lymph nodes (>15 mm in longest diameter) or any new extra nodal lesion, ≥50% increase in the longest diameter of any previous site of clinically significant lymphadenopathy, ≥50% increase in the enlargement of the liver and/or spleen, Transformation to a more aggressive histology or After treatment, the progression of any cytopenia (a decrease of hemoglobin levels >20 g/L or <10 g/dL or a decrease of platelet counts >50% or <100 x 10^9/L or by a decrease of neutrophil counts >50% or <1.0 x 10^9/L).|Randomization to clinical cutoff (median observation 42 months)|Intent-to-treat population included all randomized participants. Patients without EFS events were censored.||Months||95% Confidence Interval|Median
807135|NCT01010061|Secondary|Percentage of Participants With Best Overall Response|Best overall response according to IWCLL guidelines was defined as the percentage of patients with CR, CRi,PR or nPR. CR required all of the following: Peripheral blood lymphocytes below 4 x 10^9/L, Absence of significant lymphadenopathy, No hepatomegaly, No splenomegaly, Absence of disease, Blood counts above the following values (Neutrophils >1.5 x 10^9/L, Platelets >100 x 10^9/L, Hemoglobin >11g/dL) and Bone marrow at least normocellular for age. CRi was CR with incomplete bone marrow recovery. PR required the following for at least 2 months from end of treatment: ≥50% decrease in peripheral blood lymphocyte count from the pre-treatment value AND Either a ≥ 50% reduction in lymphadenopathy OR ≥50% reduction of liver enlargement OR ≥50% reduction of spleen enlargement PLUS at least one of the following: Neutrophils >1.5 x 10^9/ or ≥50% increase, Platelets >100 x 10^9/L or ≥50% increase, Hemoglobin 11 g/dL or ≥50% increase.|Randomization to clinical cutoff (median observation 42 months)|Participants from the Intent-to-treat population (all randomized participants) with data available for analysis. Participants who did not reach the 3 month Follow-up visit at the time of the clinical cutoff are excluded.||Percentage of participants||95% Confidence Interval|Number
807136|NCT01010061|Secondary|Percentage of Participants With End of Treatment Response (EOTR)|EOTR was the first response assessment 56 days from the last dose according to the International Workshop on Chronic Lymphocytic Leukaemia (IWCLL) guidelines. CR required: Peripheral blood lymphocytes below 4 x 10^9/L, Absence of significant lymphadenopathy, No hepatomegaly, No splenomegaly, Absence of disease, Blood counts above the following values (Neutrophils >1.5 x 10^9/L, Platelets >100 x 10^9/L, Hemoglobin >11g/dL) and Bone marrow at least normocellular for age. CRi was CR with incomplete bone marrow recovery. PR required the following for at least 2 months from end of treatment: ≥50% decrease in peripheral blood lymphocyte count from the pre-treatment value AND Either a ≥ 50% reduction in lymphadenopathy OR ≥50% reduction of liver enlargement OR ≥50% reduction of spleen enlargement PLUS at least one of the following: Neutrophils >1.5 x 10^9/ or ≥50% increase, Platelets >100 x 10^9/L or ≥50% increase, Hemoglobin 11 g/dL or ≥50% increase.|Randomization to clinical cutoff (median observation 42 months)|Participants from the Intent-to-treat population (all randomized participants) with data available for analysis. Participants who did not reach the 3 month Follow-up visit at the time of the clinical cutoff are excluded.||Percentage of participants||95% Confidence Interval|Number
807137|NCT01010061|Secondary|Percentage of Participants With Progression Free Survival Events Based on Independent Review Committee (IRC) Data|Percentage of Participants with Progression Free Survival Events: progression, relapse, or death from any cause as assessed by an Independent Review Committee.|Randomization to clinical cutoff (median observation 14.2 months)|Intent-to-treat population included all randomized participants. Participants without PFS events were censored.||Percentage of participants|||Number
807138|NCT01010061|Secondary|Progression Free Survival Based on Independent Review Committee (IRC) Data|PFS was defined as the time from randomization to the first occurrence of progression, relapse, or death from any cause as assessed by Independent Review Committee. Progressive disease required at least one of the following: ≥50% increase in the absolute number of lymphocytes, appearance of new palpable lymph nodes (>15 mm in longest diameter) or any new extra nodal lesion, ≥50% increase in the longest diameter of any previous site of clinically significant lymphadenopathy, ≥50% increase in the enlargement of the liver and/or spleen, Transformation to a more aggressive histology or After treatment, the progression of any cytopenia (a decrease of hemoglobin levels >20 g/L or <10 g/dL or a decrease of platelet counts >50% or <100 x 10^9/L or by a decrease of neutrophil counts >50% or <1.0 x 10^9/L).|Randomization to clinical cutoff (median observation 14.2 months)|Intent-to-treat population included all randomized participants. Patients without PFS events were censored.||Months||95% Confidence Interval|Median
810311|NCT01050764|Secondary|Overall Survival (OS), 1 Year|Assessed as subjects remaining alive 12 months after CD34+ cell infusion (ie, excludes death due to any cause)|1 year|Population of participants that received HSCT and T-reg plus T-con||Participants|||Number
807140|NCT01010061|Primary|Progression-free Survival (PFS)|"PFS was defined as the time from randomization to the first occurrence of progression, relapse, or death from any cause as assessed by the investigator.
Progressive disease (PD) required at least one of the following: ≥50% increase in the absolute number of lymphocytes, appearance of new palpable lymph nodes (>15 mm in longest diameter) or any new extra nodal lesion, ≥50% increase in the longest diameter of any previous site of clinically significant lymphadenopathy, ≥50% increase in the enlargement of the liver and/or spleen, Transformation to a more aggressive histology or After treatment, the progression of any cytopenia (a decrease of hemoglobin levels >20 g/L or <10 g/dL or a decrease of platelet counts >50% or <100 x 10^9/L or by a decrease of neutrophil counts >50% or <1.0 x 10^9/L)."|Randomization to clinical cutoff (median observation 42 months from randomization)|Intent-to-treat population included all randomized participants. Patients without PFS events were censored.||Months||95% Confidence Interval|Median
807141|NCT01010204|Primary|7 Day Prevalence of Abstinence From Cigarette Smoking at 24 Weeks|To evaluate the efficacy of varenicline treatment added to standard behavioral treatment for smoking abstinence|24 weeks|bipolar patients||participants|||Number
807142|NCT01010204|Secondary|Evaluate the Safety of Varenicline in Treatment-emergent Hypomania, Mania, Mixed or Depressed Episodes or Being Associated Suicidal or Aggressive Behavior or Psychotic Symptoms When Used as Adjunctive Treatment in Participants With Bipolar Disorder.||24 weeks||||||
807143|NCT01010204|Primary|7-day Prevalence of Abstinence From Cigarette Smoking at 12 Weeks|To evaluate the efficacy of varenicline treatment added to standard behavioral treatment for smoking abstinence at 12 weeks|12 weeks|bipolar subjects||participants|||Number
807144|NCT01010230|Secondary|Mean Change in Bone Turnover Ratio (RANKL/OPG) Compared Between the Intervention and Placebo Groups|"Biological markers evaluated are: Osteoprotegerin (OPG)/receptor activator nuclear factor kB ligand (sRANKL) index.
Between-group comparisons used two-sample t-tests. Biomarkers and cytokines collected at baseline and 12 months were evaluated to see if there was change over time. Variables were log transformed for analysis."|Baseline and 12 months after the intervention begins|This was an intent to treat analysis.||ratio of RANKL/OPG||Standard Deviation|Mean
807145|NCT01010230|Secondary|Mean Change in Collagen Cross Linked N-Telepeptide (NTx) Compared Between the Intervention and Placebo Groups|Biological markers of bone formation and cytokines collected at baseline and 12 months were evaluated to see if there was change over time. BCE = Bone Collagen Equivalent.|Baseline and 12 months after the intervention begins|This was an intent to treat analysis.||log of 10 nmol BCE/L||Standard Deviation|Mean
807146|NCT01010230|Secondary|Mean Change in Carboxyterminal Telopeptide of Type I Collagen (ITCP) Compared Between the Intervention and Placebo Groups|Biological markers of bone formation and cytokines collected at baseline and 12 months were evaluated to see if there was change over time.|Baseline and 12 months after the intervention begins|This was an intent to treat analysis.||log of µg/l||Standard Deviation|Mean
807147|NCT01010230|Secondary|Mean Change in Alkaline Phosphatase (ALP)-Skeletal (Bone Specific) Compared Between the Intervention and Placebo Groups|Biological markers of bone formation and cytokines collected at baseline and 12 months were evaluated to see if there was change over time.|Baseline and 12 months after the intervention begins|This was an intent to treat analysis.||log of µg/L||Standard Deviation|Mean
807148|NCT01010230|Secondary|Mean Change in Osteocalcin (OC) Compared Between the Intervention and Placebo Groups|Biological markers of bone formation and cytokines collected at baseline and 12 months were evaluated to see if there was change over time.|Baseline and 12 months after the intervention begins|This was an intent to treat analysis.||log of ng/mL||Standard Deviation|Mean
807149|NCT01010230|Primary|Percent Change in Cortical Bone Per Length Compared Between the Intervention and Placebo Groups|"Since this is considered a pilot study we did not adjust for multiple comparisons. These % changes were treated as continuous variables and analyzed using two way ANOVAs adjusting for stratification."|Baseline and 12 months after the intervention begins|This was an intent to treat analysis.||% change in mg/cm^4||Standard Deviation|Mean
807150|NCT01010230|Primary|Percent Change in Tibial Cortical Bone Compared Between the Intervention and Placebo Groups|"Since this is considered a pilot study we did not adjust for multiple comparisons. These % changes were treated as continuous variables and analyzed using two way ANOVAs adjusting for stratification."|Baseline and 12 months after the intervention begins|This was an intent to treat analysis.||% change in mg/cc||Standard Deviation|Mean
807151|NCT01010230|Primary|Percent Change in Lumbar Spine Volumetric Bone Mineral Density (BMD) Compared Between Intervention and Placebo Groups|Since this is considered a “pilot study” we did not adjust for multiple comparisons. These % changes were treated as continuous variables and analyzed using two way ANOVAs adjusting for stratification.|Baseline and 12 months after the intervention begins|This was an intent to treat analysis.||% change in mg/cc||Standard Deviation|Mean
807152|NCT01010230|Primary|Percent Change in Lumbar Spine Bone Mineral Density (BMD) Compared Between Intervention and Placebo Groups|Since this is considered a “pilot study” we did not adjust for multiple comparisons. These % changes were treated as continuous variables and analyzed using two way ANOVAs adjusting for stratification.|Baseline and 12 months after the intervention begins|This was an intent to treat analysis.||% change in g/cm^2||Standard Deviation|Mean
807153|NCT01010230|Primary|Percent Change in Total Bone Mineral Density (BMD) Compared Between Intervention and Placebo Groups|Since this is considered a “pilot study” we did not adjust for multiple comparisons. These % changes were treated as continuous variables and analyzed using two way ANOVAs adjusting for stratification.|Baseline and 12 months after the intervention begins|This was an intent to treat analysis.||% change in g/cm^2||Standard Deviation|Mean
807154|NCT01010230|Primary|Percent Change in Lumbar Spine Bone Mineral Content (BMC) Compared Between Intervention and Placebo Groups|Since this is considered a “pilot study” we did not adjust for multiple comparisons. These % changes were treated as continuous variables and analyzed using two way ANOVAs adjusting for stratification.|Baseline and 12 months after start of intervention/|This was an intent to treat analysis.||% change in grams/cm||Standard Deviation|Mean
807155|NCT01010230|Secondary|Mean Change in Aminoterminal Propeptide of Type I Procollagen (PINP) Compared Between the Intervention and Placebo Groups|Biological markers of bone formation and cytokines collected at baseline and 12 months were evaluated to see if there was change over time.|Baseline and 12 months after the intervention begins|This was an intent to treat analysis.||log of µg/L||Standard Deviation|Mean
822940|NCT01165983|Secondary|Absolute Change in Inflammatory Cytokines and Growth Factors, Osteoprotegerin, pg/mL||12 Weeks post-randomization|||pg/mL||Inter-Quartile Range|Median
807157|NCT01010282|Secondary|Change From Baseline in Conjunctival Staining Severity Score at Day 90|Change from baseline in conjunctival staining severity score at day 90. The conjunctiva is the clear membrane covering the white surface of the eye. Conjunctival staining following ocular administration of lissamine green dye was graded using a 6-point scale (0=no staining, 5=severe staining) over 6 areas of the white part of the eye for a minimum score of 0 and a maximum score of 30. The higher the score, the worse the dry eye condition. A negative number change from baseline represents a decrease in the severity of conjunctival staining (improvement).|Baseline (Day 1), Day 90|Intent-to-treat, which includes all patients who started the study (randomized).||Scores on a scale||Standard Deviation|Mean
807158|NCT01010282|Secondary|Change From Baseline in Corneal Staining at Day 90|Change from baseline in corneal staining at day 90. The cornea is the transparent front part of the eye which covers the iris and pupil. Corneal staining following administration of fluorescein dye in the eye is graded using a 6-point scale (0=no staining, 5=severe staining) over 5 areas of the clear central part of the eye for a minimum score of 0 and maximum score of 25. The higher the grade score, the worse the dry eye condition. A negative number change from baseline represents a decrease in corneal staining (improvement).|Baseline (Day 1), Day 90|Intent-to-treat, which includes all patients who started the study (randomized).||Scores on a scale||Standard Deviation|Mean
807159|NCT01010282|Secondary|Change From Baseline in Tear Break-up Time (TBUT) at Day 90|Change from baseline in TBUT at day 90. TBUT is the time required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A short TBUT is a sign of poor tear film. A positive number change from baseline indicates an increase in TBUT (improvement).|Baseline (Day 1), Day 90|Intent-to-treat, which includes all patients who started the study (randomized).||Seconds||Standard Deviation|Mean
807160|NCT01010282|Secondary|Change From Baseline in the Ocular Surface Disease Index (OSDI) Total Score at Day 90|Change from baseline in the OSDI total score at day 90. The OSDI is a 12-question survey for patients to document their dry eye disease symptoms. The OSDI consists of a 5-point scale (0=none of the time and 4=all of the time), with higher scores representing greater disability. The scores are totaled over the 12 questions and converted to a score of 0-100 (0=no disability and 100=complete disability). A negative number change from baseline represents an improvement.|Baseline (Day 1), Day 90|Intent-to-treat, which includes all patients who started the study (randomized).||Scores on a Scale||Standard Deviation|Mean
807161|NCT01010282|Primary|Change From Baseline in Subjective Evaluation of Symptom of Dryness (SESoD)Score at Day 90|Change from baseline in SESoD score at day 90. The SESoD is a 5-point scale where 0 equals no dryness, 1 equals trace dryness, 2 equals mild dryness, 3 equals moderate dryness, and 4 equals severe dryness. A negative number change from baseline indicates a decrease (improvement) in the symptom of dryness.|Baseline (Day 1), Day 90|Intent-to-treat, which includes all patients who started the study (randomized).||Scores on a Scale||Standard Deviation|Mean
807162|NCT01010399|Secondary|Proportion of Subjects With HIV-1 RNA <50 Copies/mL||24 weeks|||participants|||Number
807163|NCT01010399|Primary|Proportion of Subjects With Triglycerides <200 mg/dL||24 weeks|||participants|||Number
807164|NCT01010477|Primary|The Number of Subjects Who Quit Smoking From Weeks 5 to 8|Quit rate is defined as the proportion of individuals who self report no tobacco use during weeks 5 through 8 confirmed by exhaled carbon monoxide (CO) less than 10 parts per million (ppm) during these 4 weeks.|4 weeks|||participants|||Number
807165|NCT01010503|Secondary|Short Form-36 (SF-36)|The SF-36 measures the impact of disease on overall quality of life and consists of 8 subscales (physical function, pain, general and mental health, vitality, social function, physical and emotional health) which can be aggregated to derive a physical-component summary score and a mental-component summary score. Scores for each subscale range from 0 to 10, and the composite scores range from 0 to 100, with higher scores indicating better health.|Weeks 0, 12, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.||scores on a scale||Standard Deviation|Mean
807166|NCT01010503|Secondary|Health Assessment Questionnaire - Disability Index (HAQ-DI) Score|The HAQ-DI was used to assess the physical ability and functional status of participants as well as quality of life. The disability dimension consists of 20 multiple choice items concerning difficulty in performing 8 common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Participants choose from 4 response categories, ranging from 'without any difficulty' (Score=0) to 'unable to do' (Score=3). The overall score is the average of each of the 8 category scores and ranges from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability.|Weeks 0, 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.||scores on a scale||Standard Deviation|Mean
807167|NCT01010503|Secondary|C-Reactive Protein (CRP)|CRP is an acute phase protein. Levels of CRP increase with inflammation.|Weeks 0, 4, 12, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.||mg/L||Standard Deviation|Mean
807168|NCT01010503|Secondary|Erythrocyte Sedimentation Rate (ESR)|ESR indirectly measures how much inflammation is in the body. A higher ESR is indicative of increased inflammation.|Weeks 0, 4, 12, 20, and 24|TT population; n=number of participants assessed for the specified parameter at a given visit.||mm/hr||Standard Deviation|Mean
807169|NCT01010503|Secondary|Tender Joint Count (TJC)|The following 28 joints were assessed by the physician for tenderness: metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2). Joints were rated as 0=not tender or 1=tender. The total number was calculated from all the joints for a maximum score of 28.|Weeks 0, 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.||tender joints||Standard Deviation|Mean
807170|NCT01010503|Secondary|Swollen Joint Count (SJC)|The following 28 joints were assessed by the physician for swelling: metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2). Joints were rated as 0=not swollen or 1=swollen. The total number was calculated from all the joints for a maximum score of 28.|Weeks 0, 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.||swollen joints||Standard Deviation|Mean
808053|NCT01019694|Secondary|Change From Baseline in FVC at Week 12|Change from test-day baseline in Forced Vital Capacity (FVC) at 1 hour post dose at Week 12|baseline, 12 weeks|Treated Set is defined as all patients who were randomized and received study drug||liters||Standard Error|Least Squares Mean
807171|NCT01010503|Secondary|Physician's Global Assessment of Disease Activity|Physician's global assessment of disease activity was performed using a 100 mm VAS ranging from no arthritis activity (0) to maximal arthritis activity (100). The physician was asked to mark the line corresponding to their perceived level of the participant's disease activity and the distance in mm from the left edge of the scale was measured.|Weeks 0, 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.||units on a scale||Standard Deviation|Mean
807172|NCT01010503|Secondary|Patient Global Assessment of Disease Activity|The participant's assessment of disease activity was performed using a 100 mm VAS ranging from no activity (0) to maximal activity (100). The participant was asked to mark the line corresponding to their perceived level of disease activity and the distance in mm from the left edge of the scale was measured.|Weeks 0, 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.||units on a scale||Standard Deviation|Mean
807173|NCT01010503|Secondary|Patient Global Assessment of Pain|Participants were asked to rate their pain using a 0 to 100 mm visual analog scale (VAS), where 0 mm = no pain and 100 mm = worst possible pain. The participant was asked to mark the line corresponding to their perceived level of pain and the distance in mm from the left edge of the scale was measured.|Weeks 0, 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.||units on a scale||Standard Deviation|Mean
807174|NCT01010503|Primary|Percentage of Participants With Dose Reduction to Tocilizumab 4 mg/kg||Weeks 0, 4, 8, 12, 16, and 20|ITT Population||percentage of participants|||Number
807175|NCT01010503|Primary|Percentage of Participants Withdrawing From the Study Prematurely for Any Reason||Weeks 0, 4, 8, 12, 16, 20, and 24|ITT Population||percentage of participants|||Number
807176|NCT01010503|Primary|Percentage of Participants Receiving Greater Than (>) 1 Dose Who Discontinued Treatment for Any Reason||Weeks 0, 4, 8, 12, 16, 20, and 24|ITT Population||percentage of participants|||Number
807177|NCT01010503|Primary|Percentage of Participants Receiving Less Than or Equal to (≤) 1 Dose of Study Drug Who Discontinued Treatment for Any Reason||Weeks 0, 4, 8, 12, 16, 20, and 24|ITT Population||percentage of participants|||Number
807178|NCT01010503|Secondary|Disease Activity Score Based on 28-Joint Count (DAS28)|DAS28 calculated from the number of swollen joints and tender joints using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 ≤3.2 equals (=) low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|Weeks 0, 4, 12, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.||units on a scale||Standard Deviation|Mean
807179|NCT01010503|Primary|Percentage of Participants Adherent to Original Treatment|Adherence rate to original treatment according to the protocol included all participants that received the study drug beginning from Week 8 and remaining until the end of the study. This number represents participants with no changes in treatment protocol, participants with treatment discontinuation, and participants with dose reduction, but not participants that withdrew from the study prematurely.|Week 24|Intent-to-treat population (ITT), all enrolled participants who received at least one dose of study drug||percentage of participants|||Number
807180|NCT01010555|Primary|On-eye Wettability|On-eye wettability, as assessed at the 4-week visit by a masked observer from a video taken of the eye 5 minutes after lens insertion. On-eye wettability was recorded on a 5-point scale, with 0=excellent and 4=very poor.|4 weeks of wear|Analysis conducted per protocol, with exclusions due to reasons such as, major protocol deviations as determined by masked review; discontinuations; and/or missing responses.||units on a scale||Standard Deviation|Mean
807181|NCT01010568|Secondary|Median PFS|Kaplan Meyer PFS|2 years|||months||95% Confidence Interval|Median
807182|NCT01010568|Secondary|Complete Response Rate|NCI IWG response criteria|6 months|||participants|||Number
807183|NCT01010568|Primary|Overall Response Rate|40% per the National Cancer Institute Working Group Response Criteria for Chronic Lymphocytic Leukemia|6 months|||participants|||Number
807184|NCT01010633|Primary|Grade 0 Pain|Number of eyes with grade 0 ocular pain. Ocular pain, defined as a positive sensation of the eye, based on a 0-5 scale where grade 0 equaled no pain and grade 5 equaled severe pain. Ocular pain graded by participants.|Visit 5 (Postoperative Day 8)|Intent to treat population (ITT)||Eyes|Participants||Number
807185|NCT01010633|Secondary|Resolution of Anterior Chamber Cells.|Study eyes with complete resolution of anterior chamber cells (ACC)|At visits 4-7- postoperative day 3, 8,15 & 18|||Eyes|||Number
807186|NCT01010633|Primary|Resolution of Anterior Chamber Cells (ACC).|Number of Study eyes with complete resolution(Grade 0) of anterior chamber cells (ACC) for loteprednol and vehicle. Accumulation of white cells in aqueous graded on a scale of 0-4 where grade 0=no cells. Investigators assessed ACC using a slit lamp.|Visit 5 (Postoperative day 8)|Intent to treat (ITT) population||Eyes|Participants||Number
807187|NCT01010750|Secondary|CAARS-S:S Subscale T-Score: Attention Deficit Hyperactivity Disorder (ADHD) Index|Consists of 12 items with each item rated on a scale of 0-3 (not at all, just a little, pretty much, very much). The T-score is then calculated as: T = 50 + 10 * (raw score - mean)/Standard Deviation. The average score is 50. Scores below 50 are better than scores above 50.|2 and 14 hours post-dose on Day 7|PD||Units on a scale||Standard Error|Mean
807188|NCT01010750|Secondary|CAARS-S:S Subscale T-Score: Problems With Self-Concept|Consists of 5 items with each item rated on a scale of 0-3 (not at all, just a little, pretty much, very much). The T-score is then calculated as: T = 50 + 10 * (raw score - mean)/Standard Deviation. The average score is 50. Scores below 50 are better than scores above 50.|2 and 14 hours post-dose on Day 7|PD||Units on a scale||Standard Error|Mean
807189|NCT01010750|Secondary|CAARS-S:S Subscale T-Score: Impulsivity/Emotional Liability|Consists of 5 items with each item rated on a scale of 0-3 (not at all, just a little, pretty much, very much). The T-score is then calculated as: T = 50 + 10 * (raw score - mean)/Standard Deviation. The average score is 50. Scores below 50 are better than scores above 50.|2 and 14 hours post-dose on Day 7|PD||Units on a scale||Standard Error|Mean
807190|NCT01010750|Secondary|CAARS-S:S Subscale T-Score: Hyperactivity/Restlessness|Consists of 5 items with each item rated on a scale of 0-3 (not at all, just a little, pretty much, very much). The T-score is then calculated as: T = 50 + 10 * (raw score - mean)/Standard Deviation. The average score is 50. Scores below 50 are better than scores above 50.|2 and 14 hours post-dose on Day 7|PD||Units on a scale||Standard Error|Mean
807191|NCT01010750|Secondary|Conners Adult ADHD Rating Scales-Self Report: Short Version (CAARS-S:S) Subscale Total Score (T-Score): Inattention/Memory Problems|Consists of 5 items with each item rated on a scale of 0-3 (not at all, just a little, pretty much, very much). The T-score is then calculated as: T = 50 + 10 * (raw score - mean)/Standard Deviation. The average score is 50. Scores below 50 are better than scores above 50.|2 and 14 hours post-dose on Day 7|PD||Units on a scale||Standard Error|Mean
807192|NCT01010750|Primary|Power of Attention Score|The Power of Attention score reflects the ability to focus attention, and is calculated as the sum of the reaction time, measured in milliseconds, from 3 attention tests (Simple Reaction Time, Choice Reaction Time, and Digit Vigilance Speed). Faster performance (lower times) reflects more intense concentration. A decrease in the Power of Attention score indicates improvement.|pre-dose and at 1, 2, 3, 4, 5, 8, 12, 14 and 16 hours post-dose on Day 7|The Pharmacodynamic Set (PD) is all subjects in the Safety Set who had at least 1 post-dose assessment of the pharmacodynamic variables. The Safety Set contains all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||milliseconds||Standard Error|Mean
807193|NCT01010776|Other Pre-specified|Change From Baseline in ESRS Total Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase|An ESRS scale is used to assess the extrapyramidal symptoms attributable to antipsychotics. It consists of 8 items to assess individual symptoms and each item is assessed from 0 (none, normal) to 4 (severe). The total score is the sum of the 8 item scores, for a total range of 0 (normal) to 32 (severe). The items for the assessment of individual symptoms are classified into 4 categories of parkinsonism, akathisia, dystonia and dyskinesia.|Baseline, Week 4, 8, 13, 26, 39 and 52|The safety analysis population included all the participants that received at least 1 dose of study medication and provided 1 post-baseline information. Here ‘N’ specifies those participants who were evaluated for this outcome measure and ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.||Units on a scale||Standard Deviation|Mean
807194|NCT01010776|Other Pre-specified|Change From Baseline in Extrapyradimal Symptoms Rating Scale (ESRS) Total Score at Week 4, 8, 13 and 26 - Main Phase|An ESRS scale is used to assess the extrapyramidal symptoms attributable to antipsychotics. It consists of 8 items to assess individual symptoms and each item is assessed from 0 (none, normal) to 4 (severe). The total score is the sum of the 8 item scores, for a total range of 0 (normal) to 32 (severe). The items for the assessment of individual symptoms are classified into 4 categories of parkinsonism, akathisia, dystonia and dyskinesia.|Baseline, Week 4, 8, 13 and 26|The safety analysis population included all the participants that received at least one dose of study medication and provided any post-baseline information. Here ‘N’ specifies those participants who were evaluated for this outcome measure and ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.||Units on a scale||Standard Deviation|Mean
807195|NCT01010776|Secondary|36-Item Short-Form Health Survey (SF-36) Score - Main Phase Plus Extension Phase|The SF-36 is designed to assess the health status of participants. The SF-36 includes 1 multi-item scale measuring physical health component and mental health component. Physical health component includes physical functioning, role limitations due to physical health, pain and general health. Mental health component includes role limitations due to emotional problems, energy/fatigue, emotional well being and social functioning. Each item is scored on a 0-100 range so that the lowest and highest possible scores are set at 0 and 100, respectively. All items are scored so that a high score defines a more favorable health state. The score for a component (physical or mental) is an average of the individual item scores. Each component is scored on a scale of 1 to 100, where 100=highest level of functioning.|Baseline and Week 52|The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Here ‘N’ specifies those participants who were evaluated for this outcome measure.||Units on a scale||Standard Deviation|Mean
807196|NCT01010776|Secondary|36-Item Short-Form Health Survey (SF-36) Score - Main Phase|The SF-36 is designed to assess the health status of participants. The SF-36 includes 1 multi-item scale measuring physical health component and mental health component. Physical health component includes physical functioning, role limitations due to physical health, pain and general health. Mental health component includes role limitations due to emotional problems, energy/fatigue, emotional well being and social functioning. Each item is scored on a 0-100 range so that the lowest and highest possible scores are set at 0 and 100, respectively. All items are scored so that a high score defines a more favorable health state. The score for a component (physical or mental) is an average of the individual item scores. Each component is scored on a scale of 1 to 100, where 100=highest level of functioning.|Baseline and Week 26|The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Here ‘N’ specifies those participants who were evaluated for this outcome measure.||Units on a scale||Standard Deviation|Mean
807197|NCT01010776|Secondary|Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase|Participant’s response regarding satisfaction with the treatment were recorded. A 5-point evaluation scale was used to evaluate participant satisfaction: very good, good, moderate, bad and very bad.|Baseline, Week 4, 8, 13, 26, 39 and 52|The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.||Percentage of participants|||Number
807198|NCT01010776|Secondary|Percentage of Participants With Treatment Satisfaction - Main Phase|Participant’s response regarding satisfaction with the treatment were recorded. A 5-point evaluation scale was used to evaluate participant satisfaction: very good, good, moderate, bad and very bad.|Baseline, Week 4, 8, 13 and 26|The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Here ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.||Percentage of Participants|||Number
807218|NCT01010932|Primary|Sensitivity|Rate of true stenotic segments (i.e. with stenosis >= 70%) of TOF and Dotarem-enhanced MRA evaluated by 3 independent off-site readers at the segment level, with CTA as standard of truth (re-read DGD-44-060).|2-42 days|For 3 patients, MRA images were not analyzed: 2 patients with incomplete images and 1 patient who did not undergo CTA procedure.||percentage of stenotic segments|Participants|95% Confidence Interval|Number
822941|NCT01165983|Secondary|Absolute Change in Biochemical Markers of Endothelial Function, E-Selectin, ng/mL||12 Weeks post-randomization|||ng/mL||Inter-Quartile Range|Median
807199|NCT01010776|Secondary|Number of Participants With Clinical Global Impression–Severity (CGI-S) Score - Extension Phase|"The CGI-S rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant.The categories included in the scale are normal, without any disease, borderline, slightly ill, moderately ill, markedly ill, severely ill and extremely ill. A rating of 1=Normal, not at all ill and a rating of 7 =Among the most extremely ill participants. Higher scores indicate worsening."|Week 39 and 52|The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Here ‘N’ specifies those participants who were evaluated for this outcome measure and ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.||Participants|||Number
807200|NCT01010776|Secondary|Number of Participants With Clinical Global Impression–Severity (CGI-S) Score - Main Phase|"The CGI-S rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant.The categories included in the scale are normal, without any disease, borderline, slightly ill, moderately ill, markedly ill, severely ill and extremely ill. A rating of 1=Normal, not at all ill and a rating of 7 =Among the most extremely ill participants. Higher scores indicate worsening."|Baseline, Week 4, 8, 13 and 26|The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Here ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.||Participants|||Number
807201|NCT01010776|Secondary|Change From Baseline PSQI Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase|The PSQI evaluates sleep behavior by means of 7 components: sleep quality, sleep latency, sleep duration, usual sleep efficiency, sleep disorders, use of sleep medication and daytime dysfunction. The sum of the 7 component scores produces a global score of subjective sleep quality that varies from 0 to 21, with higher scores indicating worse sleep quality.|Baseline, Week 4, 8, 13, 26, 39 and 52|The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Here ‘N’ specifies those participants who were evaluated for this outcome measure and ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.||Units on a scale||Standard Deviation|Mean
807202|NCT01010776|Secondary|Change From Baseline in Pittsburg Sleep Quality Index (PSQI) Score at Week 4, 8, 13 and 26 - Main Phase|The PSQI evaluates sleep behavior by means of 7 components: sleep quality, sleep latency, sleep duration, usual sleep efficiency, sleep disorders, use of sleep medication and daytime dysfunction. The sum of the 7 component scores produces a global score of subjective sleep quality that varies from 0 to 21, with higher scores indicating worse sleep quality.|Baseline, Week 4, 8, 13 and 26|The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Here ‘N’ specifies those participants who were evaluated for this outcome measure and ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.||Units on a scale||Standard Deviation|Mean
807203|NCT01010776|Secondary|Change From Baseline in PSP Scale Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase|The PSP scale evaluates the dysfunction degree exhibited by the participants, regarding 4 behavioral domains: useful social activities, personal and social relations, self-care and agitated and aggressive behavior. Each domain were assessed on a 6-point scale (0=absent to 5=very severe). A transformed score from 1 to 100 is generated from the raw score based on the clinical interpretation of the scores generated in the 4 areas of functioning, with a higher transformed score indicating better function.|Baseline, Week 4, 8, 13, 26, 39 and 52|The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Here ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.||Units on a scale||Standard Deviation|Mean
807204|NCT01010776|Secondary|Change From Baseline in Personal and Social Performance (PSP) Scale Score at Week 4, 8, 13 and 26 - Main Phase|The PSP scale evaluates the dysfunction degree exhibited by the participants, regarding 4 behavioral domains: useful social activities, personal and social relations, self-care and agitated and aggressive behavior. Each domain were assessed on a 6-point scale (0=absent to 5=very severe). A transformed score from 1 to 100 is generated from the raw score based on the clinical interpretation of the scores generated in the 4 areas of functioning, with a higher transformed score indicating better function.|Baseline, Week 4, 8, 13 and 26|The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Here ‘N’ specifies those participants who were evaluated for this outcome measure and ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.||Units on a scale||Standard Deviation|Mean
807205|NCT01010776|Secondary|Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase|The PANSS Positive Subscale assesses 7 positive-symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology). The PANSS Negative Subscale assesses seven negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).|Baseline, Week 4, 8, 13, 26, 39 and 52|The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Here ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.||Units on a scale||Standard Deviation|Mean
807219|NCT01010932|Primary|Technical Failure Rate|Rate of non-assessable arterial segments as measured by 3 independent readers in off-site evaluation of TOF-MRA and Dotarem-enhanced MRA (re-read DGD-44-060).|2 - 28 days|For 2 patients, MRA images were not analyzed because images were incomplete.||percentage of arterial segments|Participants|95% Confidence Interval|Number
807220|NCT01010971|Secondary|Time to Maximal Effect Over the 2-week of Double-blind Treatment Period.|The time to maximal effect is defined as the number of days until the first treatment day on which the estimated difference between Ciclesonide HFA and placebo is at least 90% of the largest estimated difference. This is based on the analyses of change from baseline in the average of AM and PM reflective TNSS scores for each day. The evaluation is made separately for each dose level of Ciclesonide HFA compared to placebo.|Week 0-2|||Days||Standard Error|Least Squares Mean
807206|NCT01010776|Secondary|Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13 and 26 - Main Phase|The PANSS positive subscale assesses 7 positive-symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology). The PANSS negative subscale assesses seven negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).|Baseline, Week 4, 8, 13 and 26|The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Here 'N' specifies those participants who were evaluated for this outcome measure and ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.||Units on a scale||Standard Deviation|Mean
807207|NCT01010776|Secondary|Percentage of Participants With Treatment Response in PANSS Total Score - Main Phase Plus Extension Phase|Participants with response in PANSS total score was defined as participants with greater than or equal to 20 percent reduction in PANSS total score from Baseline. The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Week 52|The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. LOCF method was used.||Percentage of participants||95% Confidence Interval|Number
807208|NCT01010776|Secondary|Percentage of Participants With Treatment Response in PANSS Total Score - Main Phase|Participants with response in PANSS total score was defined as participants with greater than or equal to 20 percent reduction in PANSS total score from Baseline. The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Week 26|The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. LOCF method was used.||Percentage of participants||95% Confidence Interval|Number
807209|NCT01010776|Primary|Change From Baseline in PANSS Total Score at Week 52 - Main Phase Plus Extension Phase|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Baseline and Week 52|The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. LOCF method was used.||Units on a scale||Standard Deviation|Mean
807210|NCT01010776|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 26 - Main Phase|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Baseline and Week 26|The intent-to-treat for effectiveness (ITTe) population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Last Observation Carried Forward (LOCF) method was used.||Units on a scale||Standard Deviation|Mean
807211|NCT01010867|Secondary|Number of Acute Graft Versus Host Disease (GVHD) Events in HSCT Patients Who Have Been Administered Lactobacillus Plantarum||Up to Day +100 of HSCT|||Number of GVHD events|||Number
807212|NCT01010867|Secondary|Number of Non-lactobacillus Infections|To determine incidence of bacteremia in HSCT patients who have been administered lactobacillus plantarum.|36 days (day -7 to +28 of HSCT)|||Number of non-lactobacillus infections|||Number
807213|NCT01010867|Secondary|Adherence With the Prescribed Dose, Measured as the Percentage of Prescribed Probiotic Doses|To determine the feasibility of administration of L. plantarum 299 and 299v. The treatment is considered feasible for a patient if he/she received at least 50% of the probiotic dose (>= 11 days of treatment).|22 days (day -7 to +14 of HSCT)|||percentage of prescribed doses||Full Range|Median
807214|NCT01010867|Primary|Number of Lactobacillus Plantarum Bacteremia Infections||36 days (day -7 to +28 of HSCT)|Children and adolescents undergoing hematopoietic stem cell transplantation (HSCT)||Number of infections||95% Confidence Interval|Number
807215|NCT01010906|Secondary|Maximum Concentration (Cmax) of Vaniprevir in Blood Plasma Following Single Dose Administration|Participants were administered a single dose of vaniprevir; then their blood was collected at the following time points: 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32 and 48 hours postdose. The Cmax of vaniprevir in blood plasma was based on an ANCOVA model used to analyze natural log-transformed values that were back-transformed to derive geometric least-squares mean and confidence interval.|0-48 hours postdose|Participants administered at least one dose of investigational drug.||µM||95% Confidence Interval|Geometric Mean
807216|NCT01010906|Primary|Area Under the Curve (AUC) (0-infinity) of Vaniprevir in Blood Plasma Following Single Dose Administration|Participants were administered a single dose of vaniprevir; then their blood was collected at the following time points: 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32 and 48 hours postdose. The AUC (0-infinity) of vaniprevir in blood plasma was based on an analysis of covariance (ANCOVA) model used to analyze natural log-transformed values that were back-transformed to derive geometric least-squares mean and confidence interval.|0-48 hours postdose|Participants administered at least one dose of investigational drug. AUC for one participant with Mild HI was not estimated due to poor correlation of the linear regression.||µM.hr||95% Confidence Interval|Geometric Mean
807217|NCT01010932|Primary|Specificity|Rate of true non-stenotic segments (i.e. without stenosis >= 70%) of TOF and Dotarem-enhanced MRA evaluated by 3 independent off-site readers at the segment level, with CTA as standard of truth (re-read DGD-44-060).|2 - 42 days|For 3 patients, MRA images were not analyzed: 2 patients with incomplete images and 1 patient who did not undergo CTA procedure.||percentage of non-stenotic segments|Participants|95% Confidence Interval|Number
807221|NCT01010971|Secondary|Change From Baseline in the RQLQ(S) Domains at the End of the 2-week Treatment Period in Impaired Subjects With Baseline RQLQ(S) Score of ≥3.0|RQLQ(S) in subjects with baseline RQLQ[S] score ≥3.0. RQLQ(S) consists of 28 questions, each question measured on a scale of 0-6 where a higher score indicates poor quality of life. Domains: Activities (questions 1-3), Sleep (questions 4-6), Non-Nose/Eye Symptoms (questions 7-13), Practical Problems (questions 14-16), Nasal Symptoms (questions 17-20), Eye Symptoms (questions 21-24), and Emotional (questions 25-28). The overall RQLQ(S) score was calculated as the average of the mean domain scores.|Week 0-2|In Impaired Subjects with Baseline RQLQ(S) Score of ≥3.0||units on a scale||Standard Error|Least Squares Mean
807222|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported Individual AM and PM Reflective OSS in Subjects With Baseline TOSS ≥5.0|"OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Reflective OSS measures these symptoms over the previous 12-hour time interval. rTOSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline TOSS ≥5.0||units on a scale||Standard Error|Least Squares Mean
807223|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported Individual PM Reflective OSS in Subjects With Baseline TOSS ≥5.0|"OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Reflective OSS measures these symptoms over the previous 12-hour time interval. rTOSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline TOSS ≥5.0||participants||Standard Error|Least Squares Mean
807224|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported Individual AM Reflective OSS in Subjects With Baseline TOSS ≥5.0|"OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Reflective OSS measures these symptoms over the previous 12-hour time interval. rTOSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline TOSS ≥5.0||participants||Standard Error|Least Squares Mean
807225|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported Individual AM and PM Instantaneous OSS in Subjects With Baseline TOSS≥5.0|"OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Instantaneous OSS measures these symptoms over the previous 10 minute time interval. iTOSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline TOSS≥5.0||units on a scale||Standard Error|Least Squares Mean
807226|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported Individual PM Instantaneous OSS in Subjects With Baseline TOSS≥5.0|"OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Instantaneous OSS measures these symptoms over the previous 10 minute time interval. iTOSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline TOSS≥5.0||units on a scale||Standard Error|Least Squares Mean
807227|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported Individual AM Instantaneous OSS in Subjects With Baseline TOSS≥5.0|"OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Instantaneous OSS measures these symptoms over the previous 10 minute time interval. iTOSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline TOSS≥5.0||units on a scale||Standard Error|Least Squares Mean
807228|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported Individual AM and PM Reflective NSS Averaged Over the 2-week Treatment Period.|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|Intent to Treat Population. Not all subjects analyzed due to missing data.||units on a scale||Standard Error|Least Squares Mean
807229|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported Individual PM Reflective NSS Averaged Over the 2-week Treatment Period.|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|Intent to Treat Population. Not all subjects analyzed due to missing data.||units on a scale||Standard Error|Least Squares Mean
807249|NCT01011049|Secondary|Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine|Serum antibody titers for influenza vaccine serogroups A/H1N1, A/H3N2, and B were assessed by the hemagglutinin inhibition (HAI) assay.|Day 0 and Day 28 post-vaccination|Serum antibody geometric mean titers were assessed in the per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
807230|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported Individual AM Reflective Nasal Symptom Scores (NSS) Averaged Over the 2-week Treatment Period.|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:
0 = absent (no sign/symptom evident);
= mild
= moderate
= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|Intent to Treat Population. Not all subjects analyzed due to missing data.||units on a scale||Standard Error|Least Squares Mean
807231|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported Individual AM and PM Instantaneous NSS Averaged Over the 2-week Treatment Period|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);
= mild
= moderate
= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|Intent to Treat Population. Not all subjects analyzed due to missing data.||units on a scale||Standard Error|Least Squares Mean
807232|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported Individual PM Instantaneous NSS Averaged Over the 2-week Treatment Period|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);
= mild
= moderate
= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|Intent to Treat Population. Not all subjects analyzed due to missing data.||units on a scale||Standard Error|Least Squares Mean
807233|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported Individual AM Instantaneous NSS Averaged Over the 2-week Treatment Period|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);
= mild
= moderate
= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|Intent to Treat Population. Not all subjects analyzed due to missing data.||units on a scale||Standard Error|Least Squares Mean
807234|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported AM and PM Instantaneous TOSS Averaged Over the 2-week Treatment Period in Subjects With Baseline TOSS ≥5.0.|"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TOSS symptom scores assess symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In subjects with baseline TOSS ≥5.0||units on a scale||Standard Error|Least Squares Mean
807235|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported PM Instantaneous TOSS Averaged Over the 2-week Treatment Period in Subjects With Baseline TOSS ≥5.0.|"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TOSS symptom scores assess symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In subjects with baseline TOSS ≥5.0||units on a scale||Standard Error|Least Squares Mean
807236|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported AM Instantaneous TOSS Averaged Over the 2-week Treatment Period in Subjects With Baseline TOSS ≥5.0.|"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TOSS symptom scores assess symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In subjects with baseline TOSS ≥5.0||units on a scale||Standard Error|Least Squares Mean
807237|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported PM Reflective TOSS Averaged Over the 2-week Treatment Period in Subjects With Baseline TOSS ≥5.0|"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TOSS symptom scores assess symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In subjects with baseline TOSS ≥5.0||units on a scale||Standard Error|Least Squares Mean
807238|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported AM Reflective TOSS Averaged Over the 2-week Treatment Period in Subjects With Baseline TOSS ≥5.0|"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TOSS symptom scores assess symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In subjects with baseline TOSS ≥5.0||units on a scale||Standard Error|Least Squares Mean
807274|NCT01011556|Secondary|DRAIZE Erythema Assessment at Baseline Through 13 Month Follow-up|Severity of erythema was categorized based on a 5 point scale: 0=no erythema, 4=severe erythema (defined as beet red to eschar)|13 Month follow-up|All randomized participants who received at least 1 dose of study drug and had erythema measurements at 13 months.||participants|||Number
807239|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported PM Instantaneous TNSS Averaged Over the 2-week Treatment Period.|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|Intent to Treat Population. Not all subjects analyzed due to missing data.||units on a scale||Standard Error|Least Squares Mean
807240|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported AM Instantaneous TNSS Averaged Over the 2-week Treatment Period.|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week0-2|Intent to Treat Population. Not all subjects analyzed due to missing data.||units on a scale||Standard Error|Least Squares Mean
807241|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported PM Reflective TNSS Averaged Over the 2 Week Treatment Period.|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|Intent to Treat Population. Not all subjects analyzed due to missing data.||units on a scale||Standard Error|Least Squares Mean
807242|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported AM Reflective TNSS Averaged Over the 2-week Treatment Period.|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|Intent to Treat Population. Not all subjects analyzed due to missing data.||units on a scale||Standard Error|Least Squares Mean
807243|NCT01010971|Secondary|Change From Baseline in the RQLQ(S) Overall Score at the End of the 2-week Treatment Period in Impaired Subjects With Baseline RQLQ(S) Score of ≥3.0|RQLQ(S) in impaired subjects with baseline RQLQ[S] score ≥3.0. RQLQ(S) consists of 28 questions, each question measured on a scale of 0-6 where a higher score indicates poor quality of life. Domains: Activities (questions 1-3), Sleep (questions 4-6), Non-Nose/Eye Symptoms (questions 7-13), Practical Problems (questions 14-16), Nasal Symptoms (questions 17-20), Eye Symptoms (questions 21-24), and Emotional (questions 25-28). The overall RQLQ(S) score was calculated as the average of the mean domain scores.|Week 0-2|Intent to Treat Population. Not all subjects analyzed due to missing data.||units on a scale||Standard Error|Least Squares Mean
807244|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported AM and PM Reflective TOSS Averaged Over the 2-week Treatment Period in Subjects With Baseline TOSS ≥5.0|"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TOSS symptom scores assess symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|Intent to Treat Population. Not all subjects analyzed due to missing data.||units on a scale||Standard Error|Least Squares Mean
807245|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported AM and PM Instantaneous TNSS Averaged Over the 2-week Treatment Period.|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|Intent to Treat Population. Not all subjects analyzed due to missing data.||units on a scale||Standard Error|Least Squares Mean
807246|NCT01010971|Primary|Change From Baseline in Daily Subject-reported AM and PM Reflective TNSS Averaged Over the Two-week Treatment Period.|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|Intent to Treat Population. Not all subjects analyzed due to missing data.||Units on a scale||Standard Error|Least Squares Mean
807247|NCT01011049|Secondary|Percentage of Subjects Who Achieved Seroconversion After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine|Seroconversion was defined as either a pre vaccination hemagglutinin inhibition (HAI) titer < 1:10 and a post vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and a minimum 4 fold increase at 28 days post-vaccination.|Day 28 post vaccination|Serum antibody titers were assessed in the per protocol population.||Percentage of Participants|||Number
807248|NCT01011049|Secondary|Percentage of Participants Who Achieved Seroprotection Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine.|Seroprotection was defined as a hemagglutinin inhibition (HAI) titer ≥ 1:40 at Day 28 post-vaccination.|Day 28 post-vaccination|Serum antibody titers were assessed in the per-protocol population.||Percentage of Participants|||Number
807250|NCT01011049|Primary|Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine|Solicited injection site reactions: Erythema (redness), Swelling, Induration, Pain, Pruritus, Ecchymosis. Solicited systemic reactions: Headache, Myalgia, Malaise, Shivering, Fever (temperature).|Day 0 through Day 7 post-vaccination|Safety analysis was on all enrolled and vaccinated subjects with available reaction data, intent-to-treat population.||Participants|||Number
807251|NCT01011075|Secondary|Toxicities|Adverse events of grade 3 or higher, according to CTCAE version 3|12 months|All enrolled and treated patients were evaluated for grade 3 or higher toxicities.||Number of events|||Number
807252|NCT01011075|Secondary|Progression Free Survival|Number of months post treatment without measurable progression according to RECIST criteria (version 1.0)|12 months|6 of the enrolled 34 patients were inevaluable for the primary endpoint of Response Rate due to withdrawal or death prior to first response assessment.||Months||95% Confidence Interval|Median
807253|NCT01011075|Secondary|Overall Survival|Overall survival as measured by the Kaplan-Meier method|12 Months|6 of the enrolled 34 patients were inevaluable for the primary endpoint of Response Rate due to withdrawal or death prior to first response assessment.||Months||95% Confidence Interval|Median
807254|NCT01011075|Primary|Response Rate|Response rates according to RECIST criteria (version 1.0) expressed as percentage of evaluable patients.|6 months|6 of the enrolled 34 patients were inevaluable for the primary endpoint of Response Rate due to withdrawal or death prior to first response assessment.||Percentage of Participants||95% Confidence Interval|Number
807255|NCT01011153|Secondary|To Compare Biopsy/Referral Performance and Diagnostic Performance Using Areas Under the Corresponding Receiver Operating Characteristic (ROC) Curves That Illustrate the Trade-offs Between Sensitivity and Specificity Between Three Groups of Physicians.|For each case reviewed, physicians were asked if they thought the lesion was a melanoma (diagnostic sensitivity/specificity) and whether or not they would biopsy or refer the lesion (biopsy/referral sensitivity/specificity. These measurements were compared using areas under the corresponding receiver operating characteristic curves. (see statistical analysis for results) ROC curves (reciver operating curves) are plotted on graphs with an x-axis of sensitivity and a y-axis of 1-specificity.|June 2010|||Area Under Curve for biopsy/referral||Standard Deviation|Geometric Mean
807256|NCT01011153|Secondary|Determine the Interobserver Variability in Each of the Above Metrics Within Each of the Caregiver Groups.|Each physician was given up to 130 cases and asked whether or not they would biopsy the lesion. Interobserver variability was measured via the kappa statistic indicating how well the physicians' answers to that question agreed within each group. Kappa statistics are reported in the statistical analysis. while numbers rep, they dont reflect the sgreement among the subjects|December 2009|The statistical analysis section contains the Kappa results within Each of the Caregiver Groups||Number of Cases|||Number
807257|NCT01011153|Secondary|Comparison of Biopsy/Referral Sensitivity and Specificity of MelaFind to the Average of Biopsy/Referral Sensitivity & Specificity in Each of the Three Groups of Physicians: Pigmented Skin Lesion Experts, General Dermatologists, and Primary Care Physicians|Sensitivity is the proportion of positive cases (i.e., histologically confirmed melanoma) identified as positive. Specificity is the proportion of negative cases (i.e., histologically confirmed non-melanoma) identified as negative. Because the number of cases given to each dermatologist varied, both sensitivity and specificity were computed for each dermatologist. The primary outcome as stated was to compare the sensitivity and specificity of each group of physicians to that of Melafind, which is presented in the statistical analysis.|December 2009|Each category was diminished after excluded subjects were taken into account. These included subjects who did not complete at least 78 cases, subjects who previously participated in other EOS studies, pediatricians, and a board eligible dermatologist.||Proportion of True Cases||95% Confidence Interval|Mean
807258|NCT01011153|Primary|Comparison of Biopsy/Referral Sensitivity of MelaFind and Dermatologists (Pigmented Skin Lesion Experts and General Dermatologists)|Sensitivity is the proportion of positive cases (i.e., histologically confirmed melanoma) identified as positive. Specificity is the proportion of negative cases (i.e., histologically confirmed non-melanoma) identified as negative. Because the number of cases given to each dermatologist varied, both sensitivity and specificity were computed for each dermatologist. The primary outcome as stated was to compare the sensitivity and specificity of all dermatologists to that of MelaFind. These metrics, for both the dermatologists and MelaFind, were calculated based on the same 130 lesions.|April 2010|Participants were invited to enroll in this study via mail. Minimum number of participants was determined by statistician based on power analyses and number of cases completed. The time frame of the study was about 6 months and the comparison between Dermatologists and MelaFind is presented in the statistical analysis section below.||Proportion of True Cases||95% Confidence Interval|Mean
807259|NCT01011179|Secondary|Stress (Perceived Stress Questionnaire; PSQ)||Baseline (prior to randomization) and 3 months after intervention||||||
807260|NCT01011179|Secondary|Adherence to Treatment (Child Adherence Report Questionnaire; CARQ)||Baseline (prior to randomization) and 3 months after intervention||||||
807261|NCT01011179|Secondary|Self-efficacy (Children's Arthritis Self-Efficacy Scale; CASE)||Baseline (prior to randomization) and 3 months after intervention||||||
807262|NCT01011179|Secondary|Pain Coping (Pain Coping Questionnaire)||Baseline (prior to randomization) and 3 months after intervention||||||
807263|NCT01011179|Secondary|Disease Specific Knowledge (Medical Issues, Exercise, Pain and Social Support Questionnaire; MEPS)||Baseline (prior to randomization) and 3 months after intervention||||||
807264|NCT01011179|Primary|Juvenile Arthritis Quality of Life Questionnaire (JAQQ)|The questionnaire is divided into 4 dimensions: gross motor function, fine motor function, psychosocial function, and general symptoms. A 7-point ordinal scale is used to rate responses to each item from 1 (none of the time) to 7 (all of the time), based on how often the item was a problem for the child over the past 2 weeks. Total score was composed of the 4 dimension scores (top 5 items of that dimension) divided by 4, with higher scores denoting poorer HRQOL.|Baseline (prior to randomization) and 3 months after intervention|||units on a scale||Standard Deviation|Mean
807275|NCT01011556|Secondary|DRAIZE Edema Assessment at Baseline Through 13 Month Follow-up|Severity of edema was categorized based on a 5 point scale: 0=no edema, 4=severe edema (defined as an area raised more than 1 millimeter and extending beyond area of exposure)|13 Month follow-up|All randomized participants who received at least 1 dose of study drug and had edema measurements at 13 months.||participants|||Number
807265|NCT01011283|Secondary|Overall Response Rate (ORR), Defined as Proportion of Patients Having Complete Response (CR) and Marrow Complete Response (mCR) After Completion of 6 Cycles of Study Drug.|"Based on Modified International Working Group Response Criteria for Altering Natural History of Myelodysplastic Syndromes.
Complete Response: Bone marrow: ≤ 5% myeloblasts with normal maturation of all cell lines. Persistent dysplasia will be noted. Peripheral blood Hgb ≥ 11 g/dL; Platelets ≥ 100 X 10^9/L; Neutrophils ≥ 1.0 X 10^9/Lb; Blasts 0%.
Marrow Complete Response: Bone marrow: ≤ 5% myeloblasts and decrease by ≥ 50% over pretreatment. Peripheral blood: if hematological improvement responses, they will be noted in addition to marrow CR."|36 Weeks|Intent to Treat Population||Percentage of Participants|||Number
807266|NCT01011283|Primary|Overall Response Rate (ORR), Defined as Proportion of Patients Having Complete Response (CR) and Marrow Complete Response (mCR) After Completion of 3 Cycles of Study Drug.|"Based on Modified International Working Group Response Criteria for Altering Natural History of Myelodysplastic Syndromes.
Complete Response: Bone marrow: ≤ 5% myeloblasts with normal maturation of all cell lines. Persistent dysplasia will be noted. Peripheral blood Hgb ≥ 11 g/dL; Platelets ≥ 100 X 10^9/L; Neutrophils ≥ 1.0 X 10^9/Lb; Blasts 0%.
Marrow Complete Response: Bone marrow: ≤ 5% myeloblasts and decrease by ≥ 50% over pretreatment. Peripheral blood: if hematological improvement responses, they will be noted in addition to marrow CR."|13 Weeks|Intent to Treat Population||Percentage of Participants|||Number
807267|NCT01011309|Secondary|IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10)|Immunogenicity of the vaccine was evaluated by measuring IgG antibody and T-cell responses to the LEISH-F2 protein and soluble Leishmania antigen (SLA). IgG antibodies were measured by ELISA and T-cell cytokine responses (IFN-g and IL-10) were measured by Luminex. Data is presented as median Post:Pre ratios comparing Days 56/84 or 168 to baseline at Day 0.|Days 0, 56 or 84, and 168|Per-protocol population: patients who received all three study injections (immunotherapy groups) or at least 15 SSG injections (chemotherapy group) and completed the Day 84 or Day 56 visit.||Relative ELISA Units||Full Range|Median
807268|NCT01011309|Primary|Adverse Events of Grade 1 Severity or Higher Occurring in ≥ 3 Patients During Active Treatment Phase of the Study.|Safety of immunotherapy with the vaccine was compared to the safety of chemotherapy with sodium stibogluconate. All adverse events are listed regardless of relatedness.|Day 0 through Day 84|Safety population: All patients who received at least one study injection.||participants|||Number
807269|NCT01011309|Primary|Date of Clinical Cure|Efficacy of immunotherapy with the LEISH-F2 + MPL-SE vaccine was compared to the efficacy of chemotherapy with sodium stibogluconate in the treatment of CL. Efficacy is measured by the date of clinical cure.|Day 84|Per-protocol population: All patients who received all three study injections if in the immunotherapy groups or at least 15 injections of SSG if in the chemotherapy group, and completed the Day 56 visit (Immunotherapy v1.6), the Day 84 visit (Immunotherapy v1.4/1.5), or the Day 56 or Day 84 visit (Chemotherapy group).||participants|||Number
807270|NCT01011387|Primary|Mean Change in Wound Area.|Measured by tracing of wound and measured by planimeter.|From baseline to maximum 4 weeks|||cm2||Full Range|Mean
807271|NCT01011465|Primary|Speech Threat and Challenge|Measure of threat and challenge calculated from observation of non-verbal behavioral cues during stress exposure. Threat (negative reaction) results when an individual does not feel that he or she has sufficient resources to complete a task or manage a difficult situation. Its reverse, challenge (positive reaction), occurs when an individual perceives that he or she has sufficient resources. Independent observers used videotapes of behavior during the stress tasks and rated participants on 7 point scales for 11 challenge-related behaviors (comfortable, confident, enthusiastic, clear, alert, high level of eye contact, etc), and for 8 threat-related behaviors (agitation, rigid posture, speech disfluency, etc). Challenge scores were averaged, and threat scores averaged then reverse-scored. The mean of challenge and reversed threat scores comprise the score used here. Range: 1.1 to 6.1, with higher scores representing more challenge orientation and reflecting a better outcome.|2 hours|All participants who received oxytocin or placebo, who completed the study, had relevant covariate data, and for whom speech threat score was calculated, were included||units on a scale||Standard Deviation|Mean
807272|NCT01011465|Primary|Difference of Pre-count and Baseline Self-reported Negative Affect (Using Negative Sub-scale of Positive and Negative Affect Schedule (PANAS) Measure).|Based on 20-item Positive and Negative Affect Schedule (PANAS) which comprises two mood scales, positive affect and negative affect. Each item is rated on a 5-point scale ranging from (1 = very slightly or not at all) to (5 = extremely) to indicate how the respondent felt at the moment the question was asked. Here, we’ve used the negative affect sub-scale which consists of the sum of the 10 negative affect items, with a possible range of 10 (least negative affect) to 50 (most negative affect). This score was measured at baseline (study range: 10 to 29) and directly before stress exposure (study range: 10 to 37), and the reported value is the difference between these two scores (range of differences: -13 to 26). It estimates negative affect due to anticipatory stress. The value is the difference between the pre-stress measure and baseline measure, therefore a larger number for the difference means a bigger increase in negative affect due to anticipatory stress, and is a worse outcome.|2 hours|All participants who received oxytocin or placebo, who completed the study, had relevant covariate data, and for whom negative affect score was calculated, were included||units on a scale||Standard Deviation|Mean
807273|NCT01011465|Primary|Systolic Blood Pressure Change From Baseline to Second Stress Task Experience - Autonomic Stress Response Measure|Systolic blood pressure (SBP)is connected with reaction to exposure to stress. Systolic blood pressure is collected at baseline and after nasal spray administration/directly before stress tasks; it represents anticipatory stress reaction. This measure represents the difference between baseline and pre-task systolic blood pressure values. A greater difference score represents an increase from baseline in systolic blood pressure during the pre-task, and so a larger difference score represents higher reactivity. A lower difference score, or negative difference score, indicates a lower increase, or even decrease, from baseline in systolic blood pressure during the pre-task and reflects less reactivity. Reactivity is associated with increased risk of developing hypertension. Range of baseline/pre-count differences in SBP: -11 to 37.7|within 2 hours of treatment|All participants who received oxytocin or placebo, who completed the study, had relevant covariate data, and for whom systolic blood pressure was collected, were included||mm Hg||Standard Deviation|Mean
807276|NCT01011556|Secondary|Pharmacokinetics Parameters: Maximal Concentration (Cmax)|Due to high intra-subject variability, data was not analyzed for this outcome measure.|Baseline, 1 Month, 3 Months, 12 Months|Due to high intra-subject variability, zero participants were analyzed for this outcome measure.|||||
807278|NCT01011556|Secondary|Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels|Participants were tested for anti-recombinant teriparatide and anti-synthetic teriparatide titers. Either none were detected (ND) or antibodies were determined to be present if the teriparatide specific antibody titers were at least 1:8 (titer 1:8).|Baseline and 1, 3, 12, and 13 Months (mon)|All randomized participants who received at least one dose of study drug and had antibody results.||participants|||Number
807279|NCT01011556|Secondary|Change From Pre-dose to Postdose in Supine and Standing Heart Rate at Baseline (BL) and 12 Months (Mon).||Pre-dose, 30 minutes, 2 hours at Baseline and 12 Months|All randomized participants who received at least 1 dose of study drug and had predose and postdose heart rate measurements at the indicated timepoint and body position.||beats per minute (bpm)||Standard Deviation|Mean
807280|NCT01011556|Secondary|Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon)|Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) measured at pre-dose and 30 minutes (min) and 2 hours (hr) post-dose in both the supine and standing position.|Pre-Dose, 30 minutes, 2 hours Post-Dose at Baseline and 12 Months|All randomized participants who received at least 1 dose of study drug and had predose and postdose blood pressure measurements at the indicated timepoint and body position.||mmHg||Standard Deviation|Mean
807281|NCT01011556|Secondary|Change From Baseline in Urine Calcium Excretion at 6 and 12 Months||Baseline, 6 Months, 12 Months|All randomized participants who received at least 1 dose of study drug and had urine calcium measurements at the indicated timepoint.||millimole/day (mmol/day)||Standard Deviation|Mean
807282|NCT01011556|Secondary|Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours|Serum calcium adjusted for serum albumin levels is calculated using the following formula: Total Calcium + [(40 - albumin) x 0.02]. Analysis for serum calcium and albumin adjusted serum calcium were collected at predose, 4 hours (h) post-dose (PD) and 6 h PD at baseline and 12 months (mon).|Baseline, 12 Months|All randomized participants who received at least 1 dose of study drug and had serum calcium measurements or adjusted serum calcium measurements at the indicated timepoint.||millimole/Liter (mmol/L)||Standard Deviation|Mean
807283|NCT01011556|Secondary|Convenience/Ease of Use Questionnaire (CEUQ)|CEUQ consists of 5 sections and 16 questions using a 5-point Likert scale designed to collect measures for ease of use (S1), convenience of use (S2), confidence of use (S3), fear of use (S4), and overall satisfaction with therapy (S5). CEUQ is not a validated instrument.|baseline up to 12 months|All randomized participants who received at least 1 dose of study drug and had CEUQ assessment. Last observation was carried forward, unless the last observation was also the first completed questionnaire.||participants|||Number
807284|NCT01011556|Secondary|Percent Change From Baseline in Serum Procollagen Type 1 C-Propeptide (P1CP) at 1 Month|Procollagen Type 1 N-Terminal Propeptide (P1NP) is a marker of bone formation.|Baseline, 1 Month|All randomized participants who received at least one dose of study drug. The intent-to-treat principle was applied.||percentage change in P1CP||Standard Deviation|Median
807285|NCT01011556|Secondary|Percent Change From Baseline of C-Terminal Telopeptide (CTX)|C-terminal telopeptide is a marker of bone resorption.|Baseline, 1 Month, 3 Months, 6 Months, 12 Months|All randomized participants who received at least one dose of study drug. The intent-to-treat principle was applied.||percentage change in CTX||Standard Deviation|Mean
807286|NCT01011556|Secondary|Percent Change From Baseline in Procollagen Type 1 N-Terminal Propeptide (P1NP)|Procollagen Type 1 N-Terminal Propeptide (P1NP) is a marker of bone formation.|Baseline, 1 Month, 3 Months, 6 Months, 12 Months|All randomized participants who received at least one dose of study drug. The intent-to-treat principle was applied.||percentage change in P1NP||Standard Deviation|Mean
807287|NCT01011556|Secondary|Time Course Change of BMD Response at the Lumbar Spine|To assess the time course of the treatment, the BMD data of the lumbar spine was assessed by dual energy X-ray absorptiometry (DXA) and analyzed using a mixed model repeated measures (MMRM) method, with the repeated measure occurring at each visit (for example, 6 and 12 month). BMD values are corrected data and have been standardized across the machine types (Hologic and Lunar).|Baseline to 6 Months and 12 Months|All participants who received at least 1 dose of drug, had at least 1 baseline and post-baseline lumbar spine BMD measure. Analysis was performed using ITT principal.||percentage change in BMD||90% Confidence Interval|Least Squares Mean
807288|NCT01011556|Secondary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 6 Months|Bone mineral density (BMD) of the lumbar spine was assessed by dual energy X-ray absorptiometry (DXA). BMD values are corrected data and have been standardized across the machine types (Hologic and Lunar). Analyses were performed using ANCOVA model with the baseline value as a covariate and pooled site and treatment as fixed effects.|Baseline, 6 Months|All participants who received at least 1 dose of drug and had at least 1 baseline and post-baseline lumbar spine BMD measure. Analysis was performed using intent-to-treat principal, last observation carried forward method and ANCOVA model.||percentage change in BMD||90% Confidence Interval|Least Squares Mean
807289|NCT01011556|Primary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 12 Months|Bone mineral density (BMD) of the lumbar spine was assessed by dual energy X-ray absorptiometry (DXA). BMD values are corrected data and have been standardized across the machine types (Hologic and Lunar). Analyses were performed using ANCOVA model and least square (LS) means were adjusted for baseline BMD values as a covariate and pooled site and treatment as fixed effects.|Baseline, 12 Months|All participants who received at least 1 dose of drug and had at least 1 baseline and post-baseline lumbar spine BMD measure. Analysis was performed using intention-to-treat (ITT) principle, last observation carried forward method and ANCOVA model.||percentage change in BMD||90% Confidence Interval|Least Squares Mean
807290|NCT01011634|Primary|Pain Score Within 5 Mins After Procedure||within 5 mins after procedure|Study was stopped due to low enrollment (7%). No data analysis performed.|||||
807291|NCT01011634|Secondary|Acceptability of Pain, Would They Choose the Same Regimen Again for Another Uterine Aspiration||30 min after procedure|Study was stopped due to low enrollment (7%). No data analysis performed.|||||
807292|NCT01011673|Secondary|Satisfaction Scores|"24 hours after the emergency department visit, patients were asked, The next time you come to the Er with this type of headache, do you want to receive the same medication? Affirmative answers are tabulated here."|24 hours|3 patients in each group were lost to follow-up. All others are tabulated here.||participants|||Number
814960|NCT01092663|Primary|Appearance Rate of Oral Glucose|Change from baseline in appearance rate of oral glucose after 12 weeks of colesevelam alone or colesevelam plus sitagliptin treatments|baseline and 12 weeks|||umol per kg per min||Standard Deviation|Mean
807293|NCT01011673|Primary|Change in Pain Score|At baseline at at 60 minutes, all patients were asked to describe their pain on a scale from 0 to 10, with 0 representing no pain and 10 the worst imaginable. The primary outcome is the 60 minute score subtracted from the baseline score|Baseline, 60 minutes|3 randomized patients were not included in this analysis. During the ED visit, these patients were diagnosed with intracranial hemorrhage, brain abscess, and malaria and therefore did not truly have a primary headache disorder. Including these patients, 123 were randomized.||units on a scale||Standard Deviation|Mean
807294|NCT01011738|Secondary|Number of Deaths During Observation Period|The clinical endpoint of deaths due to any cause during observation period is presented.|Up to 276 Weeks|Safety population was defined to include participants with informed consent who received at least one dose of peginterferon alfa-2a and had at least one post-baseline safety assessment (any assessment after baseline).||Participants|||Number
807295|NCT01011738|Secondary|Number of Participants With Adverse Events and Serious Adverse Events|An Adverse Events (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator’s judgment or requires intervention to prevent one or other of these outcomes.|Up to 276 Weeks|Safety population was defined to include participants with informed consent who received at least one dose of PEG IFN and had at least one post-baseline safety assessment (any assessment after baseline).||Participants|||Number
807296|NCT01011738|Secondary|Number of Participants With Non-Serious Adverse Drug Reactions|Non serious adverse drug reactions (NSADRs) are all noxious and unintended responses to a medicinal product related to any dose.|Up to 276 Weeks|Safety population was defined to include participants with informed consent who received at least one dose of PEG IFN and had at least one post-baseline safety assessment (any assessment after baseline).||Participants|||Number
807297|NCT01011738|Secondary|Number of Participants With Serious Adverse Drug Reactions|"A serious adverse drug reactions (SADR) is any untoward medical occurrence suspected to be medicinal product-related that at any dose: Results in death, is life-threatening, NOTE: The term life-threatening in the definition of serious refers to an event in which the patient was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe. Requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or Is a congenital anomaly/birth defect."|Up to 276 Weeks|Safety population was defined to include participants with informed consent who received at least one dose of PEG IFN and had at least one post-baseline safety assessment (any assessment after baseline).||Participants|||Number
807298|NCT01011738|Secondary|Number of Participants With Chronic Hepatitis B Associated Clinical Endpoints- Liver Cirrhosis|Number of participants with clinical endpoints associated with CHB captured in the medical record, where data available, are reported. The clinical endpoints included development of cirrhosis (in participants without cirrhosis at baseline). The liver cirrhosis assessments were summarized from Week 12 to 3 years post-treatment.|Up to 276 Weeks|mITT included all participants of the target population who could be classified regarding their HBeAg status. The target analysis population was per the inclusion/exclusion criteria mentioned in the protocol.||Participants|||Number
807299|NCT01011738|Secondary|Number of Participants With Chronic Hepatitis B - Associated Clinical Endpoints- Liver Transplantation, Hepatocellular Carcinoma, and Liver Decompensation|Number of clinical endpoints associated with CHB reported in the medical record, where data available, are reported. The clinical endpoints included liver transplantation, hepatocellular carcinoma, liver decompensation, development of cirrhosis (in patients without cirrhosis at baseline).|Up to 276 Weeks|mITT population included all participants of the target population who could be classified regarding their HBeAg status. The target analysis population was per the inclusion/exclusion criteria mentioned in the protocol.||Participants|||Number
807300|NCT01011738|Secondary|Alanine Transaminase Ratio Over Time by Hepatitis B Virus e Antigen Status|ALT ratio was calculated as serum ALT, divided by the upper limit of the normal range.|Up to 276 Weeks|mITT population included all participants of the target population who could be classified regarding their HBeAg status. The target analysis population was per the inclusion/exclusion criteria mentioned in the protocol.||Ratio||Standard Deviation|Mean
807301|NCT01011738|Secondary|Percentage of Participants With Normalization of Alanine Transaminase|A participant was considered to have achieved normalization of alanine transaminase (ALT) if the ALT measurement was lower or equal to the upper limit of the normal range. Only patients with elevated ALT at baseline were included in any analyses where normalization of ALT was used as endpoint. It was analyzed as last serum ALT in the analyzed time window, divided by the upper limit of the normal range.|Up to 276 Weeks|mITT included all participants of the target population who could be classified regarding their HBeAg status. The target analysis population was per the inclusion/exclusion criteria mentioned in the protocol.||Percentage of Participants||95% Confidence Interval|Number
807302|NCT01011738|Secondary|Quantitative Hepatitis B Surface Antigen|Quantitative HBsAg assay is a diagnostic test for assessing the amount of the HBsAg in chronic hepatitis B participants. Last approved quantitative HBsAg measurement in the analyzed time window.|Up to 276 Weeks|mITT population included all participants of the target population who could be classified regarding their HBeAg status. The target analysis population was per the inclusion/exclusion criteria mentioned in the protocol.||Log10 IU/mL||Standard Deviation|Mean
807303|NCT01011738|Secondary|Percentage of Participants With Hepatitis B Surface Antigen Seroconversion|Hepatitis B surface antigen (HBsAg) is a viral protein detectable in the blood in acute and chronic hepatitis B infection. A participant was considered to have achieved HBsAg seroconversion if (a) the participant achieved HBsAg clearance and (b) the last approved anti-HBs measurement in the analyzed time window was reported as i) ‘POSITIVE’ or (ii) quantitative result and was greater than or equal to the reported lower limit of detection.|Up to 276 Weeks|mITT population included all participants of the target population who could be classified regarding their HBeAg status. The target analysis population was per the inclusion/exclusion criteria mentioned in the protocol.||Percentage of Participants||95% Confidence Interval|Number
807304|NCT01011738|Primary|Predictive Values of Early on Treatment Response for Hepatitis B Surface Antigen Clearance 3 Years Post-Treatment- Hepatitis B Virus e Antigen Negative Participants|The probability that the participant who develops an early virological/serological response would achieve HBsAg clearance 3 years post-treatment is called the PPV of the early virological/serological response. The probability that the participant who fails to develop an early virological/serological response also would fail to achieve HBsAg clearance 3 years post-treatment is called the NPV of the early virological/serological response. The positive and negative predictive values of early response at Weeks 12 and 24 on achievement of HBsAg clearance at 3 years post-treatment were examined. The following evidence of early response was explored (giving both NPV and PPV): For HBeAg negative patients, any decline in HBsAg from baseline to Week 12 and 24 and at least a 10% decline in HBsAg from baseline to Weeks 12 and 24.|Up to 276 Weeks|mITT population included all participants of the target population who could be classified regarding their HBeAg status. The target analysis population was per the inclusion/exclusion criteria mentioned in the protocol.||Percentage of Participants||95% Confidence Interval|Number
807305|NCT01011738|Secondary|Percentage of Participants With Hepatitis B Virus e Antigen Seroconversion and Hepatitis B Virus Deoxyribonucleic Acid <2000IU/mL in Hepatitis B Virus e Antigen Positive Participants|"A participant was considered to have achieved HBeAg seroconversion and suppression of HBV DNA to <2,000 IU/mL if (a) the participant achieved HBeAg seroconversion and (b) the participant achieved suppression of HBV DNA to <2,000 IU/mL. If a patient received NUCs after end of PEG IFN treatment, then a reported suppression of HBV DNA to < 2,000 IU/mL during or after this NUC treatment were to be ignored, and HBV DNA ≥ 2,000 IU/mL was to be assigned. However, HBV DNA < 2,000 IU/mL was not to be ignored, if the NUC treatment given parallel to PEG IFN was discontinued within the first 8 weeks after end of PEG IFN treatment and prior to the HBV DNA value concerned no further NUCs were administered.
Abbreviations for Seroconversion=sercnvrsn, Analysis A= AnalysA, and Analysis B= AnalysB, pt=post-treatment."|Up to 276 Weeks|mITT population included all participants of the target population who could be classified regarding their HBeAg status. The target analysis population was per the inclusion/exclusion criteria mentioned in the protocol.||Percentage of Participants||95% Confidence Interval|Number
807306|NCT01011738|Secondary|Percentage of Participants With Hepatitis B Virus e Antigen Loss in Hepatitis B Virus e Antigen Positive Participants|A participant was considered to have achieved HBeAg loss if the HBeAg measurement was reported as (a) ‘NEGATIVE’ or (b) a quantitative result was lower than the reported lower detection limit. This endpoint was measured in the participants with HBeAg positive CHB.|Up to 276 Weeks|mITT population included all participants of the target population who could be classified regarding their HBeAg status. The target analysis population was per the inclusion/exclusion criteria mentioned in the protocol.||Percentage of Participants||95% Confidence Interval|Number
807307|NCT01011738|Secondary|Percentage of Participants With Hepatitis B Virus e Antigen Seroconversion in Hepatitis B Virus e Antigen Positive Participants|"HBeAg seroconversion is presented as percentage of participants who become HBeAg negative and anti-HBe positive. A participant was considered to have achieved HBeAg seroconversion if (a) the participant achieved HBeAg loss and (b) the anti-HBe measurement was reported as (i) ‘POSITIVE’ or (ii) a quantitative result considered ‘positive’ in the context. HBeAg seroconversion and suppression of HBV DNA to <2,000 IU/mL: A participant was considered to have achieved HBeAg seroconversion and suppression of HBV DNA to <2,000 IU/mL if (a) the participant achieved HBeAg seroconversion and (b) the participant achieved suppression of HBV DNA to <2,000 IU/mL.
Abbreviations for pt=post-treatment."|Up to 276 Weeks|mITT population included all participants of the target population who could be classified regarding their HBeAg status. The target analysis population was per the inclusion/exclusion criteria mentioned in the protocol.||Percentage of Participants||95% Confidence Interval|Number
807308|NCT01011738|Primary|Predictive Values of Early on Treatment Response for Hepatitis B Surface Antigen Clearance 3 Years Post-Treatment- Hepatitis B Virus e Antigen Positive Participants|The probability that the participant who develops an early virological/serological response would achieve Hepatitis B Surface Antigen (HBsAg) clearance 3 years post-treatment is called the positive predictive value (PPV) of the early virological/serological response. The probability that the participant who fails to develop an early virological/serological response also would fail to achieve HBsAg clearance 3 years post-treatment is called the negative predictive value (NPV) of the early virological/serological response. The positive and negative predictive values of early response at Weeks 12 and 24 on achievement of HBsAg clearance at 3 years post-treatment were examined. The following evidence of early response was explored (giving both NPV and PPV): For HBeAg positive participant, HBsAg <1,500 International Units Per Milliliter (IU/mL) and HBsAg <20,000 IU/mL at Weeks 12 and 24.|Up to 276 Weeks|mITT population included all participants of the target population who could be classified regarding their HBeAg status. The target analysis population was per the inclusion/exclusion criteria mentioned in the protocol. Data of participants available at the assessment time point were included in the analysis.||Percentage of Participants||95% Confidence Interval|Number
807309|NCT01011738|Secondary|Percentage of Participants With Suppression of Hepatitis B Virus Deoxyribonucleic Acid to <2,000 International Units Per Milliliter|A participant was considered to have achieved suppression of Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) to <2,000 International Units Per Milliliter (IU/mL) if the HBV DNA measurement is lower than 2,000 IU/mL.|Up to 276 Weeks|mITT population included all participants of the target population who could be classified regarding their HBeAg status. The target analysis population was per the inclusion/exclusion criteria mentioned in the protocol.||Percentage of Participants||95% Confidence Interval|Number
807325|NCT01011868|Primary|Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) After 18 Weeks of Treatment|Change from baseline in Glycosylated haemoglobin A1c (HbA1c) after 18 weeks of treatment|Baseline and 18 weeks|"FAS18-completers-included FAS patients not prematurely discontinue prior to Week 18, completed required minimum treatment duration, and had an on treatment HbA1c value within Week 18 time window. Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF-18) was used for imputation.
(LOCF-18)"||percentage of HbA1c||Standard Error|Mean
807344|NCT01012037|Secondary|FPG Change From Baseline at Week 12|Change from baseline reflects the Week 12 FPG minus the baseline FPG. Treatment means are adjusted for baseline HbA1c, baseline fasting plasma glucose and use of prior oral antidiabetics (OADs) in addition to background metformin.|Baseline and week 12|Patients from FAS with values for FPG at baseline and on-treatment. Last observation carried forward (LOCF) was used as the imputation rule.||mg/dL||Standard Error|Mean
807310|NCT01011738|Primary|Percentage of Participants With Hepatitis B Virus Surface Antigen Clearance|Percentage of participants who became Hepatitis B Virus Surface Antigen (HBsAg) negative by the end of the observation period. A participant was considered to have achieved HBsAg clearance if the HBsAg measurement was reported as: (a) ‘Negative’ or (b) a quantitative result lower than the reported lower limit of detection. An observational period was upto 3 years post-treatment. The analysis was performed by 2 methods: Analysis A and Analysis B. For analysis A, all participants included in the analyzed population were used (participants with missing measurement for calculation of the endpoint were considered non-responders regarding the endpoint). For analysis B method, only participants in the analyzed population without missing measurements for calculation of the endpoint were used (analysis “as observed”).|Up to 276 Weeks|mITT population included all participants of the target population who could be classified regarding their HBeAg status. The target analysis population was per the inclusion/exclusion criteria mentioned in the protocol. Data of participants available at the assessment time point were included in the analysis.||Percentage of Participants||95% Confidence Interval|Number
807311|NCT01011816|Secondary|Roland-Morris Disability Questionnaire Score|"Percent of subjects achieving a minimum 30% decrease in Roland-Morris Disability Questionnaire score
The Roland-Morris Disability Questionnaire is a widely studied and frequently used instrument for the assessment of function and disability related to low back pain. The questionnaire consists of 24 statements related to how a subject’s back condition affects various activities of daily living. Subjects marked whether the statement either applied to them or did not apply at the time they responded to the statements. The score is the total number of questions with which the subject agreed. A higher score indicates less function and greater disability."|26-weeks|All subjects assigned as success or failure. Missed 26-week visit counted as failure (7 BIOSTAT BIOLOGX; 2 Saline). Unblinded subjects counted as failures (2 BIOSTAT BIOLOGX).||percentage of subjects|||Number
807312|NCT01011816|Secondary|Visual Analog Scale for Low Back Pain|"Percent of subjects achieving a minimum 30% decrease in pain from baseline.
The visual analog scale is a horizontal 100 mm line anchored on the left with the words “No Pain” and on the right with the words “Worst Possible Pain”. Scores were obtained by measuring the distance in millimeters from the left origin of the line (0) to the point indicated with a slash placed by the subject to indicate the subject’s level of low back pain experienced over the last week."|26-weeks|All subjects assigned success or failure. Missed 26-week visit counted as failure (7 BIOSTAT BIOLOGX; 2 Saline). Unblinded subjects counted as failures (2 BIOSTAT BIOLOGX).||percentage of subjects|||Number
807313|NCT01011816|Primary|Subject Composite Success|Subject success based on a composite of minimum 30% decrease in low back pain, 30% improvement in function, maintenance of neurological status, no secondary interventions, and no serious adverse events.|26 weeks|All subjects adjudicated as a success or failure. Missed 26-week visit counted as failure (7 BIOSTAT BIOLOGX; 2 Saline). Unblinded subjects counted as failures (2 BIOSTAT BIOLOGX).||percentage of subjects|||Number
807314|NCT01011829|Secondary|Retention (Completion)|Retention was determined by the proportion of participants retained for the entire trial and time until drop-out.|8-weeks|Intention to treat||participants|||Number
807315|NCT01011829|Primary|Change in MA Positive Urine Drug Screens Among Participants Randomly Assigned to Receive Varenicline Versus Placebo.|Urine samples, collected thrice weekly, were tested for metabolites of MA using radioimmunoassay. Each subject had a possible of 24 urine drug screens to provide during the 8 weeks of medication. An aggregate measure of urine drug screen results was calculated - the Treatment Effectiveness Score (TES) - which is the average of the sum of MA-free urine specimens provided during the treatment period by participants in each treatment condition.|8-weeks|Intention to treat||total MA-free urine drug screens|Participants|Standard Deviation|Mean
807316|NCT01011868|Secondary|The Occurrence of Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <7.0% After 18, 54, and 78 Weeks of Treatment|The occurrence of treat to target efficacy response, that is an HbA1c under treatment of <7.0% After 18, 54, and 78 weeks of treatment|Baseline, 18, 54 and 78 weeks|FAS (NCF)||participants|||Number
807317|NCT01011868|Other Pre-specified|Confirmed Hypoglycemic Events|Confirmed hypoglycemic events refer to all hypoglycemic events that had a glucose value ≤70 ml/dL or where assistance was required. Symptomatic hypoglycemic events were to be reported as adverse events. Investigator-defined hypoglycaemia adverse events include all events that investigator marked as ‘Hypoglycaemic event’ in CRFs, regardless of the reported term or blood glucose value. It may include hypoglycemia itself as reported term or any other symptoms that that investigator may have attributed to hypoglycemia (e.g. dizziness, hyperhidrosis, and asthenia).|During the course of the study (82 weeks)|Treated set (TS). Treatment assignment as first medication taken.||participants|||Number
807318|NCT01011868|Secondary|Change From Baseline in HbA1c After 54 and 78 Weeks of Treatment|Change from baseline in HbA1c after 54 and 78 weeks of treatment|Baseline, 54 and 78 weeks|Week 54 - FAS (OC-78) Week 78 - FAS78-completers (LOCF-78)||percentage of HbA1c||Standard Error|Mean
807319|NCT01011868|Secondary|Change From Baseline in Body Weight at Follow-up|Change from baseline in body weight at follow up (82 weeks)|Baseline and 82 weeks|FAS-FU (OR)||kg||Standard Deviation|Mean
807320|NCT01011868|Secondary|Change From Baseline in Body Weight After 18, 54 and 78 Weeks of Treatment|Change from baseline in body weight after 18, 54 and 78 weeks of treatment|Baseline, 18, 54, 78 weeks|FAS (OC)||kg||Standard Error|Mean
807321|NCT01011868|Secondary|Change From Baseline in Basal Insulin Dose/Day After 54 and 78 Weeks of Treatment|Change from baseline in basal insulin dose/day after 54 and 78 weeks of treatment|Baseline, 54 and 78 weeks|FAS (OC-78) for week 54 FAS78-completers (LOCF-78) for week 78 - Values after start of antidiabetic rescue therapy except changes in basal insulin dose were set to missing and last observation carried forward (LOCF) was used for imputation of missing values||IU||Standard Error|Mean
807322|NCT01011868|Secondary|Percent Change From Baseline in Fasting Plasma Glucose (FPG) After 18, 54 and 78 Weeks of Treatment|Percent change from baseline in fasting plasma glucose (FPG) after 18, 54 and 78 weeks of treatment|Baseline, 18, 54 and 78 weeks|FAS (OC)||percentage of Change from BL in FPG||Standard Error|Mean
807323|NCT01011868|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) After 18, 54 and 78 Weeks of Treatment|Change from baseline in fasting plasma glucose (FPG) after 18, 54 and 78 weeks of treatment|Baseline, 18, 54 and 78 weeks|FAS observed cases (OC)||mg/dL||Standard Error|Mean
817587|NCT01111851|Primary|Brain NK1-receptor Occupancy at 48 Hours Post Dose||48 hours post dose|"All participants with at least 1 successful postdose PET
scan were included in the analysis population."||Percent of occupancy||95% Confidence Interval|Geometric Mean
807326|NCT01011894|Primary|Best Response|The major criteria for determination of response to therapy in patients with CLL include physical examination and examination of the peripheral blood and bone marrow. Complete Response (CR): Absence of lymphadenopathy, hepatomegaly or splenomegaly by physical examination and appropriate radiographic techniques (if abnormal pre-treatment), No constitutional symptoms, ANC >/= 1,500/ul, platelets> 100,000/ul, Hgb>11gm/dl (untransfused); Partial Response (PR): >50% decrease in peripheral blood lymphocyte count from the pre-treatment baseline value, reduction in lymphadenopathy, reduction in size of the liver and/or the spleen; Progressive Disease (PD): Characterized by at least one of the following: > 50% increase in the sum of the products of at least 2 lymph nodes on at least 2 consecutive exams at least 2 weeks apart. At least 1 node must be >/= to 2cm in size, Appearance of new palpable LN, > 50% increase in size of liver or spleen determined by measurement below the respective costal|2 years|20 participants had Stable Disease, 3 had Progression of Disease, 3 were not evaluable due to toxicity||Participants|||Count of Participants
807327|NCT01011907|Secondary|Alcohol Craving as Measured by the Obsessive Compulsive Drinking Scale (OCDS) Between Varenicline and Placebo Groups for Completers of the Study.|Higher scores on the OCDS indicate increased craving. OCDS possible score range = 0 - 40. Difference in average OCDS scores from week 1 to week 12 were reported for the varenicline and placebo groups in subjects that completed the study.|Week 1 to Week 12|||Scores on a scale||Standard Error|Mean
807328|NCT01011907|Secondary|Average Number of Alcoholic Drinks Consumed Between the Varenicline and Placebo Groups for Completers of the Study Through Week 12.||Weeks 1-12|||drinks||Standard Error|Mean
807329|NCT01011907|Primary|Average Number of Cigarettes Smoked Between the Varenicline and Placebo Groups for Completers Through Week 12.||Weeks 1-12|||cigarettes||Standard Error|Mean
807330|NCT01011933|Other Pre-specified|Patient Vital Status|Patients alive or dead after 24 months from time of study entry.|Study entry up to 2 years|||participants|||Number
807331|NCT01011933|Other Pre-specified|Reason Off Study Therapy||from study entry until end of study treatment|||participants|||Number
807332|NCT01011933|Secondary|Duration of Overall Survival||Up to 5 years||||||
807333|NCT01011933|Secondary|Duration of Progression-free Survival||Up to 5 years||||||
807334|NCT01011933|Primary|Frequency and Severity of Adverse Effects as Assessed by CTCAE v3.0||Up to 5 years||||||
807335|NCT01011933|Primary|Objective Tumor Response Rate Assessed by RECIST|Per Response Evaluation Criteria In Solid Tumors (RECIST) Criteria: Complete Response (CR) is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Normalization of CA125, if elevated at study entry, is required; Partial Response (PR) is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD; Increasing Disease is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry; Stable Disease is any condition not meeting the above criteria.|From study entry, assessed up to 5 years|||participants|||Number
807336|NCT01011933|Primary|Number of Participants With or Without Progression-free Survival for > 6 Months by Response Evaluation Criteria for Solid Tumors (RECIST)|"Number of participants who survived progression-free for more than 6 months.
Progression is defined using Response Evaluation Criteria for Solid Tumors (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or the appearance of one or more new lesions, or unequivocal progression of existing non-target lesions in the opinion of the treating physician, or global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression."|> 6 months from study entry|||participants|||Number
807337|NCT01011946|Primary|Sensitivity and Specificity of FDG Positron Emission Mammography (PEM) in Identifying Axillary Lymph Node (ALN) Metastases From Breast Cancer|Based on FDG Positron Emission Mammography (PEM) image, a breast region was classified as “normal” or “abnormal”. Lymph Node (LN) sampling and histopathology determined true positives and true negatives.|PEM was performed prior to surgery and LN sampling immediately following surgery|||percentage of subjects||95% Confidence Interval|Number
807338|NCT01012037|Secondary|The Occurrence of a Treat to Target Efficacy Response (HbA1c <6.5 %) After 12 Weeks of Treatment|Percentage of those patients with baseline HbA1c >= 6.5% who had HbA1c < 6.5% at Week 12. The analysis was performed on the full analysis set (FAS) using NCF.|12 weeks|FAS (NCF) with baseline HbA1c >= 6.5%||percentage of participants|||Number
807339|NCT01012037|Secondary|The Occurrence of a Treat to Target Efficacy Response (HbA1c <7.0%) After 12 Weeks of Treatment|Percentage of those patients with baseline HbA1c >= 7.0% who had HbA1c < 7% at Week 12. The analysis was performed on the full analysis set (FAS) using NCF.|12 weeks|FAS (NCF) with baseline HbA1c >= 7.0%||percentage of participants|||Number
807340|NCT01012037|Secondary|Percentage of Patients With Rescue Therapy|Percentage of patients with rescue therapy at Week 12. The analysis was performed on the full analysis set (FAS) using OC.|12 weeks|||percent|||Number
807341|NCT01012037|Secondary|Percentage of Patients With HbA1c Lowering by 0.5% or More at Week 12|Percentage of patients with HbA1c lowering by at least 0.5% after 12 weeks. The analysis was performed on the full analysis set (FAS) using NCF.|Week 12|The Full Analysis Set (FAS) included all treated patients with a baseline and at least one on-treatment HbA1c measurement available. Patients without a value at Week 12 were analysed as non-responders||percent|||Number
807342|NCT01012037|Secondary|FPG Change From Baseline at Week 12 From Mixed Model Repeated Measures (MMRM) Analysis|Mixed model includes treatment, baseline HbA1c, baseline FPG, use of prior oral antidiabetics (OADs) in addition to background metformin, week repeated within patient, week by treatment interaction.|Baseline and week 12|Patients from FAS with values for FPG at baseline and on-treatment. No imputation was performed. Patients without a Week 12 value were handled by the statistical model.||percent||Standard Error|Mean
807343|NCT01012037|Secondary|FPG Change From Baseline at Week 6 From Mixed Model Repeated Measures (MMRM) Analysis|Mixed model includes treatment, baseline HbA1c, baseline FPG, use of prior oral antidiabetics (OADs) in addition to background metformin, week repeated within patient, week by treatment interaction.|Baseline and week 6|Patients from FAS with values for FPG at baseline and on-treatment. No imputation was performed. Patients without a Week 12 value were handled by the statistical model.||percent||Standard Error|Mean
817588|NCT01111851|Primary|Brain NK1-receptor Occupancy at 24 Hours Post Dose||24 hours post dose|"All participants with at least 1 successful post dose PET
scan were included in the analysis population."||Percent of occupancy||95% Confidence Interval|Geometric Mean
807345|NCT01012037|Secondary|HbA1c Change From Baseline at Week 12 From Mixed Model Repeated Measures (MMRM) Analysis|Mixed model includes treatment, baseline HbA1c, use of prior oral antidiabetics (OADs) in addition to background metformin, week repeated within patient, week by treatment interaction.|Baseline and week 12|The Full Analysis Set (FAS) included all treated patients with a baseline and at least one on-treatment HbA1c measurement available. No imputation was performed. Patients without a Week 12 value were handled by the statistical model.||percent||Standard Error|Mean
807346|NCT01012037|Secondary|HbA1c Change From Baseline at Week 6 From Mixed Model Repeated Measures (MMRM) Analysis|Mixed model includes treatment, baseline HbA1c, use of prior oral antidiabetics (OADs) in addition to background metformin, week repeated within patient, week by treatment interaction.|Baseline and week 6|The Full Analysis Set (FAS) included all treated patients with a baseline and at least one on-treatment HbA1c measurement available. No imputation was performed. Patients without a Week 6 value were handled by the statistical model.||percent||Standard Error|Mean
807347|NCT01012037|Primary|HbA1c Change From Baseline at Week 12|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Treatment means are adjusted for baseline HbA1c and use of prior oral antidiabetics (OADs) in addition to background metformin.|Baseline and week 12|The Full Analysis Set (FAS) included all treated patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||percent||Standard Error|Mean
807348|NCT01018810|Secondary|Number of Participants Who Developed Anti-LY2525623 Antibody Results Through 24 Weeks|Measures anti-LY2525263 antibody as positive or negative. Study BDAD was terminated after enrolling only 8 patients. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline through 24 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.||participants|||Number
807349|NCT01018810|Secondary|Pharmacokinetics: Area Under the Time Concentration Curve Through 24 Weeks|Area under the curve of serum drug concentration, including absolute bioavailability. Study BDAD was terminated after enrolling only 8 patients. Given the small sample size overall and in each treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline through 24 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.||nanograms per milliliter (ng/mL)||90% Confidence Interval|Geometric Mean
807350|NCT01018810|Secondary|Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) at 12 Weeks|A 14-item questionnaire with anxiety and depression subscales; 21 maximum score. Scores of 11+ on either subscale (significant case of psychological morbidity); 8-10 (borderline); 0-7 (normal). Study BDAD was terminated after enrolling only 8 patients. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline, 12 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.||units on a scale||Standard Deviation|Mean
807351|NCT01018810|Secondary|Change From Baseline in the 16-Item Quick Inventory for Depressive Symptomatology-Self Report (QIDS16SRTotal) at 12 Weeks|A 16-item patient-rated measure of depressive symptomatology. The total score ranges from 0 to 27 with higher scores indicative of greater severity. Study BDAD was terminated after enrolling only 8 patients. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline, 12 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.||units on a scale||Standard Deviation|Mean
807352|NCT01018810|Secondary|Change From Baseline in the Dermatology Life Quality Index (DLQI) Score at 12 Weeks|10-item, validated questionnaire covers 6 domains. Responses range from 0 (not at all) to 3 (very much); totals range from 0 to 30 (more impairment). Study BDAD was terminated after enrolling only 8 patients. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline, 12 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.||units on a scale||Standard Deviation|Mean
807353|NCT01018810|Secondary|Change From Baseline in the Patient's Global Assessment of Psoriasis Scale at 12 Weeks and 24 Weeks|A scale measures patient perception of psoriatic condition with a continuous range of 0 (good) to 5 (severe). Study BDAD was terminated after enrolling only 8 patients. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline, 12 weeks, 24 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.||units on a scale||Standard Deviation|Mean
807354|NCT01018810|Secondary|Change From Baseline in the Visual Analog Scale (VAS) for Psoriatic Arthritis at 12 Weeks and 24 Weeks|A global estimate of pain caused by joint disease on arising made by the subject by placing a vertical mark or tick on a 100-mm VAS from not present to worse, range from 0 to 100mm. Study BDAD was terminated after enrolling only 8 patients. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline, 12 weeks, 24 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.||millimeters (mm)||Standard Deviation|Mean
807355|NCT01018810|Secondary|Change From Baseline in Relative Physician's Global Assessment (rPGA) Scale at 12 Weeks and 24 Weeks|The rPGA rates the subject’s psoriasis relative to baseline as 1 (100% clearing), 2 (excellent; 75%-99% clearing), 3 (good; 50%-74% clearing), 4 (fair; 25%-49% clearing), 5 (poor; 0%-24% clearing), or 6 (worsening). Study BDAD was terminated after enrolling only 8 patients. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline, 12 weeks, 24 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.||units on a scale||Standard Deviation|Mean
817589|NCT01112514|Primary|Number of Neoplastic Lesions Detected||upto 15 mins|||Lesions|||Number
807356|NCT01018810|Primary|Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Scale at Weeks 12 and 24|PASI combines body-surface assessments and severity of desquamation, erythema, and plaque induration/infiltration. Overall score:0(no psoriasis) to 72(severe disease). Percent(%) improvement=(baseline PASI-observed PASI)/baseline PASI*100. Study BDAD was terminated after enrolling only 8 patients. Least Squares (LS) Mean Values were adjusted for time, treatment, and baseline. Given small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline, 12 weeks, 24 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.||percentage of units on a scale||95% Confidence Interval|Least Squares Mean
807357|NCT01018810|Primary|Percentage of Participants Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Scale by Week 12|PASI combines extent of body-surface involvement assessments in 4 anatomical regions and severity of regional desquamation, erythema, and plaque induration/infiltration. Overall score: 0 (no psoriasis) to 72 (severe disease). Study BDAD was terminated after enrolling only 8 patients. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline through 12 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.||percentage of participants|||Number
807358|NCT01018862|Secondary|Change From Baseline to Visit 4 in the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Compared to Placebo|change from baseline in the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) compared to placebo for the entire 28-day study period compared to placebo,scored on a 0 to 42 scale with 0 being not troubled at all and 42 being extremely troublesome.|baseline to 28 Days|participant must have had at least one post baseline efficacy assessment||units on a scale||Standard Deviation|Least Squares Mean
807359|NCT01018862|Secondary|Change From Baseline in 12-hour Reflective Total Ocular Symptoms Score (TOSS) and Instantaneous Total Ocular Symptoms Score (TOSS) for the Entire 28-day Study Period Compared to Placebo|change from baseline in 12-hour instantaneous total ocular symptom score (TOSS) for the entire 28-day study period compared to placebo,scored on a 0 to 18 scale with 0 being no symptoms and 18 being severe symptoms.|baseline to 28 days|participant must have had at least one post baseline efficacy assessment||units on a scale||Standard Deviation|Least Squares Mean
807360|NCT01018862|Secondary|Change From Baseline in the Instantaneous Total Nasal Symptoms Score (TNSS) for the Entire 28-day Study Period Compared to Placebo|change from baseline in 12-hour instantaneous total nasal symptom score (TNSS) for the entire 28-day study period compared to placebo,scored on a 0 to 24 scale with 0 being no symptoms and 24 being severe symptoms.|baseline to 28 days|participant must have had at least one post baseline efficacy assessment||units on a scale||Standard Deviation|Least Squares Mean
807361|NCT01018862|Primary|Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (TNSS) for the Entire 28-day Study Period Compared to Placebo|Change from baseline in 12-hour reflective total nasal symptom score (TNSS) for the entire 28-day study period compared to placebo,scored on a 0 to 24 scale with 0 being no symptoms and 24 being severe symptoms.|baseline to 28 Days|participant must have had at least one post baseline efficacy assessment||units on a scale||Standard Deviation|Least Squares Mean
807362|NCT01018953|Secondary|Concentration at 2 Hours Postdose (C2 Hours) BIM 23A760 Plasma Levels||At 8 timepoints up to week 24|Study was prematurely terminated and no data was collected/analyzed for this outcome measure.|||||
807363|NCT01018953|Secondary|Minimum Concentration (Cmin) BIM 23A760 Plasma Levels||At 9 timepoints up to 1 week after 24th administration in week 24|Study was prematurely terminated and no data was collected/analyzed for this outcome measure.|||||
807364|NCT01018953|Secondary|Number of Subjects Reported Adverse Events, Including Any Findings From an Examination of the Injection Site(s)||Up to week 26|Both ITT (Intent-To-Treat) and safety populations were the same analysis group. Treatment emergent adverse events (TEAE) reported by 2 or more patients (safety population) by primary system organ class.||Participants|||Number
807365|NCT01018953|Secondary|Change in 5 Hydroxyindoleacetic Acid (5 HIAA) and Chromogranin A||Week 24|Study was prematurely terminated and no data was collected/analyzed for this outcome measure.|||||
807366|NCT01018953|Secondary|Change in the Quality of Life (QoL) Assessment||Week 24|Study was prematurely terminated and no data was collected/analyzed for this outcome measure.|||||
807367|NCT01018953|Secondary|Percentage of Patients With Improvement in Symptoms (Diarrhoea and/or Flushes)||Up to week 24|Study was prematurely terminated and no data was collected/analyzed for this outcome measure.|||||
807368|NCT01018953|Primary|Percentage of Patients With a Positive Overall Satisfactory Relief of Symptoms (Diarrhoea and/or Flushes) on the Likert Scale|Patient satisfaction based on a Likert scale from 0-5 (0 being not satisfied and 5 being completely satisfied)|Week 24|Study was prematurely terminated and no data was collected/analyzed for this outcome measure.|||||
807369|NCT01018979|Secondary|Circulating CD34+ Cell Counts in Peripheral Blood.||Baseline, 3 hours and 6 hours after infusion|||cells/μL||Standard Deviation|Mean
807370|NCT01018979|Secondary|Volume of Distribution at Steady State (Vss) of TG-0054 in 12 Consented Patients With MM, NHL or HD.|Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.|36 hrs after infusion|According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion.||mL/kg||Standard Deviation|Mean
807371|NCT01018979|Secondary|Volume of Distribution at the Terminal State (Vz) of TG-0054 in 12 Consented Patients With MM, NHL or HD.|Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.|36 hrs after infusion|According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion.||mL/kg||Standard Deviation|Mean
807372|NCT01018979|Secondary|Clearance (CL) of TG-0054 in 12 Consented Patients With MM, NHL or HD.|Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.|36 hrs after infusion|According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion.||mL/ hr/kg||Standard Deviation|Mean
807373|NCT01018979|Secondary|The Area Under the Plasma Concentration Time Curve (AUC) From 0 Hours to Infinity of TG-0054 in 12 Consented Patients With MM, NHL or HD.|Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.|36 hrs after infusion|According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion.||hr*ng/mL||Standard Deviation|Mean
807374|NCT01018979|Secondary|The Area Under the Plasma Concentration Time Curve (AUC) From 0 Hours to Time t of TG-0054 in 12 Consented Patients With MM, NHL or HD.|Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.|36 hrs after infusion|According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion.||hr*ng/mL||Standard Deviation|Mean
807375|NCT01018979|Secondary|Terminal Elimination Rate Constant (λz) of TG-0054 in 12 Consented Patients With MM, NHL or HD.|Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.|36 hrs after infusion|According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion.||1/hr||Standard Deviation|Mean
807376|NCT01018979|Secondary|Terminal Elimination Half-life (t1/2) of TG-0054 in 12 Consented Patients With MM, NHL or HD.|Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.|36 hrs after infusion|According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion.||hr||Standard Deviation|Mean
807377|NCT01018979|Secondary|Time at Which Maximum Plasma Concentration is Observed (Tmax) of TG-0054 in 12 Consented Patients With MM, NHL or HD.|Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.|36 hrs after infusion|According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion.||hr||Standard Deviation|Mean
807378|NCT01018979|Secondary|Fold Increase of Circulating CD34+ Cell Counts in Peripheral Blood.||Baseline, 3 hours and 6 hours after infusion|||fold||Standard Deviation|Mean
807379|NCT01018979|Secondary|Maximum Plasma Concentration (Cmax) of TG-0054 in 12 Consented Patients With MM, NHL or HD.|Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.|36 hrs after infusion|According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion.||ng/mL||Standard Deviation|Mean
807380|NCT01018979|Primary|Number of Patients Who Achieved Mobilization Success of Hematopoietic Stem Cells in Patients With Multiple Myeloma (MM), Non-Hodgkin Lymphoma (NHL) or Hodgkin Disease (HD).|Patients who met the target CD34+ cell collection of ≧2 x 106 cells/kg after two apheresis sessions were classified as achieving mobilization success.|1 week|"In TG-0054 (2.24 mg/kg) group, A total of 4 patients (2 with MM, 1 with NHL, and 1 with HD) underwent apheresis procedure.
In TG-0054 (3.14 mg/kg) group, A total of 3 patients (1 with MM and 2 with NHL) underwent apheresis procedure."||participants|||Number
807381|NCT01018992|Secondary|Safety, Measured by the Number of Subjects That Experienced an Adverse Event|The occurrence of adverse events will be recorded at the end of 6 weeks.|Week 6|Intent to Treat||participants|||Number
807382|NCT01018992|Secondary|Efficacy, Measured by Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Score|The MADRS is a ten-item clinician-administered questionnaire used to measure the severity of depressive symptoms in patients with depressive disorders. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. Change is the difference in scores between baseline and 6 weeks.|Baseline, Week 6|Intent to treat analysis was performed using maximum likelihood estimation with mixed models to include all observations.||Score on a scale||Standard Deviation|Mean
807383|NCT01018992|Secondary|Efficacy, Measured by Response Rate of at Least 50% Improvement in CAPS Score at the End of 6 Weeks as Compared to Baseline|The number of participants that showed at least a 50% reduction in CAPS scores from their baseline visit at the end of 6 weeks were measured has having a response to the treatment. The CAPS is a semi-structured clinical interview providing a measure of the severity of PTSD symptoms. A severity score is calculated by summing the frequency and intensity scores for each of the 17 DSM-IV criteria symptoms. Scores may range from 0 (no symptoms) to 136 (severe symptoms).|Baseline, Week 6|Intent to treat analysis was performed with missing subjects considered to be non-responders.||participants|||Number
807384|NCT01018992|Primary|Efficacy, Measured by Change in the Clinician-Administered PTSD Scale (CAPS) Score|The CAPS is a semi-structured clinical interview providing a measure of the severity of PTSD symptoms. A severity score is calculated by summing the frequency and intensity scores for each of the 17 DSM-IV criteria symptoms. The severity of symptoms is rated on a scale from 0-4, where, 0 = Absent, 1 = Mild/subthreshold; 2 = Moderate/ threshold, 3 = Severe/markedly elevated and 4 = Extreme/ incapacitating. Scores may range from 0 (no symptoms) to 136 (severe symptoms). Change is the difference in scores between baseline and 6 weeks.|Baseline, Week 6|Intent to treat analysis was performed using maximum likelihood estimation with mixed models to include all observations.||Score on a scale||Standard Deviation|Mean
807385|NCT01022567|Secondary|The Recurrence of Conservatively Treated Appendicitis||up to 10 years||06/2022||||
807386|NCT01022567|Secondary|The Direct and Indirect Costs of Both Treatment Arms||1 year||08/2017||||
807387|NCT01022567|Secondary|The Possible Complications, Morbidity and Mortality of Operative and Conservative Treatment||1 year||||||
807388|NCT01022567|Primary|The Success of Antibiotic and Surgical Treatment in the Treatment of Acute Uncomplicated Appendicitis|A successful treatment is determined by resolution of the appendicitis by means of the assigned treatment.|Up to 10 years|Treatment success||percentage of successful treatment||95% Confidence Interval|Number
807389|NCT01022762|Secondary|Change in Body Weight||Week 0, week 16|Full analysis set (FAS) is randomised participants exposed to at least one dose of trial product after randomisation||kg||Standard Error|Least Squares Mean
807390|NCT01022762|Secondary|Cholesterol|"The number of participants having a change in cholesterol from normal to abnormal. Abnormal means a value of blood cholesterol is out of the normal range."|Week 0, week 16|Safety analysis set contains all randomised participants exposed to at least one dose of trial drug(s)||participants|||Number
807391|NCT01022762|Secondary|Number of All Treatment Emergent Hypoglycaemic Episodes|A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of trial product and no later than the last day of the trial product.|Weeks 0-16|Safety analysis set contains all randomised participants exposed to at least one dose of trial drug(s). One participant was randomised into repaglinide group, but was dispensed gliclazide from the very beginning of the study due to the investigator's negligence. This participant continued the gliclazide treatment until the end of the study.||episodes|||Number
807392|NCT01022762|Secondary|Change in AUC0-180 of Plasma Glucose Concentration of IVGTT||Over the course of three hours at Week 0 and Week 16|A total of 69 participants were recruited into IVGTT, and were randomised into repaglinide treatment group (35 participants) and gliclazide treatment group (34 participants). Participants with eligible IVGTT profiles were included in IVGTT analysis set.||min*mmol/L||Standard Deviation|Mean
807393|NCT01022762|Secondary|Change in AUC0-180 of Serum Insulin Concentration of IVGTT (Intravenous Glucose Tolerance Test)||Over the course of three hours at Week 0 and Week 16|A total of 69 participants were recruited into IVGTT, and were randomised into repaglinide treatment group (35 participants) and gliclazide treatment group (34 participants). Participants with eligible IVGTT profiles were included in IVGTT analysis set.||min*pmol/L||Standard Deviation|Mean
807394|NCT01022762|Secondary|Change in 2-hour Postprandial Serum Free Fatty Acid (FFA) Over a Standard Meal||Week 0, week 16|Full analysis set (FAS) is randomised participants exposed to at least one dose of trial product after randomisation. Missing values were replaced with the last post-baseline data based on LOCF (last observation carried forward).||mmol/L||Standard Error|Least Squares Mean
807395|NCT01022762|Secondary|Change in Fasting Serum Free Fatty Acid (FFA) From Baseline||Week 0, week 16|Full analysis set (FAS) is randomised participants exposed to at least one dose of trial product after randomisation. Missing values were replaced with the last post-baseline data based on LOCF (last observation carried forward).||mmol/L||Standard Error|Least Squares Mean
807396|NCT01022762|Secondary|Percentage of Participants Achieving the Treatment Target of HbA1c Below or Equal to 6.5%||Week 16|Full analysis set (FAS) is randomised participants exposed to at least one dose of trial product after randomisation. Missing values were replaced with the last post-baseline data based on LOCF (last observation carried forward).||percentage of participants|||Number
807397|NCT01022762|Secondary|Change in 2-hour Postprandial Plasma Glucose (PPG) Over a Standard Meal|A standard meal contains 100g carbohydrate|Week 0, week 16|Full analysis set (FAS) is randomised participants exposed to at least one dose of trial product after randomisation. Missing values were replaced with the last post-baseline data based on LOCF (last observation carried forward).||mmol/L||Standard Error|Least Squares Mean
807398|NCT01022762|Secondary|Change in Fasting Plasma Glucose||Week 0, week 16|Full analysis set (FAS) is randomised participants exposed to at least one dose of trial product after randomisation. Missing values were replaced with the last post-baseline data based on LOCF (last observation carried forward).||mmol/L||Standard Error|Least Squares Mean
807399|NCT01022762|Primary|Change in Glycosylated Haemoglobin (HbA1c)||Week 0, week 16|Full analysis set (FAS) is randomised participants exposed to at least one dose of trial product after randomisation. Missing values were replaced with the last post-baseline data based on LOCF (last observation carried forward).||percentage (%) of total haemoglobin||Standard Error|Least Squares Mean
807400|NCT01022996|Secondary|Progression Free Survival (PFS) by Kaplan-Meier Estimate|Progression-free survival (PFS) was defined as the time from the first date of treatment to the date of first documented disease progression or death due to any cause or start of a new antineoplastic therapy. An event for PFS was defined as a documented disease progression or death due to any cause or start of a new antineoplastic therapy, whichever occurred first. Cycle = 28 days.|Every three months beginning at Cycle 3 until end of treatment due to progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason|Full analysis set (FAS): consisted of all patients who received at least 1 dose of study drug and was the primary set for efficacy analyses.||Days||95% Confidence Interval|Median
807401|NCT01022996|Secondary|Duration of Disease Control|The duration of overall response (CR/PR) was applied only to patients whose best overall response was CR or PR. Duration of overall response was calculated from the date of the first documented response of CR or PR to the date of first documented disease progression or death due to any cause or start of a new antineoplastic therapy.|Every three months beginning at Cycle 3 until end of treatment due to progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason|Full analysis set (FAS): consisted of all patients who received at least 1 dose of study drug and was the primary set for efficacy analyses.||Days||Standard Deviation|Mean
807402|NCT01022996|Secondary|Disease Control Rate (DCR)|The disease control rate was defined as the percentage of patients with a best overall response of CR, PR or stable disease (SD).|Every three months beginning at Cycle 3 until end of treatment due to progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason|Full analysis set (FAS): consisted of all patients who received at least 1 dose of study drug and was the primary set for efficacy analyses.||Percentage of participants||95% Confidence Interval|Number
807403|NCT01022996|Secondary|Duration of Overall Response (DoR)|The duration of overall response was calculated from the date of first documented response (CR or PR) to the date of first documented disease progression or death due to any cause or start of a new antineoplastic therapy. This only applies to patients whose best overall response is CR or PR.|Every three months beginning at Cycle 3 until end of treatment due to progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason|Full analysis set (FAS): consisted of all patients who received at least 1 dose of study drug and was the primary set for efficacy analyses.||Days||Standard Deviation|Mean
807404|NCT01022996|Secondary|Time to Overall Response (TTR) Per Kaplan-Meier Estimate|Time to overall response was defined as the time from the first date of treatment to the date of first documented response of CR or PR. Time to overall response is applied to patients whose best overall response is CR or PR. Patients who drop-out or did not have a response (CR or PR) will be treated as censored at the date of last adequate tumor assessment.|Every three months beginning at Cycle 3 until end of treatment due to progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason|Full analysis set (FAS) consisted of all patients who received at least 1 dose of study drug and was the primary set for efficacy analyses.||Days||95% Confidence Interval|Median
807405|NCT01022996|Primary|Overall Response Rate (ORR) Based on the Assessments by Investigator|ORR: % of patients whose overall disease response was a complete response (CR) or a partial response (PR) in 8 cycles CR: Complete normalization of all index nodal & extranodal lesions: Radiological regression to normal size of all lymph nodes & nodal masses & complete disappearance of all lesions PR: At least a 50% decrease in the SPD of all index nodal & extranodal lesions FDG-avid or PET positive prior to therapy: one or more PET positive at previously involved site.At least a 50% increase in the SPD of all index nodal & extranodal lesions, taking as reference the smallest sum of the product of the diameters of all index lesions recorded at or after baseline . Lesions PET positive if FDG-avid lymphoma or PET positive prior to therapy. Unknown (UNK): Progression not documented & one or more of the index lesions not assessed or assessed using a different method than baseline at the time of radiologic evaluation. Each cycle was 28 days.|at screening and every threee months beginning at cycle 3 until end of treatment due to progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason|Full analysis set (FAS) consisted of all patients who received at least 1 dose of study drug and was the primary set for efficacy analyses.||percentage of participants|||Number
807406|NCT01023022|Secondary|Handling of Unscheduled Activities (for Example, Symptoms and Events)|"Investigators were asked to classify reasons for unscheduled visits by marking all applicable answers. Answer: 1) patient symptoms 2) adequate therapy/shock 3) appearance of already known arrythmias 4) appearance of new arrythmias 5) need for reprogramming 6) in house Follow-up 7) device alert 8) inadequate therapy/shock 9) worsening of pump function 10) malfunction of the device 11) other"|Baseline to max. 12 months|The 68 patients of total population (176) were analyzed as this number of pt. had experienced unscheduled visit during the study.||% of unscheduled visits due to reasons|unscheduled visits||Number
807407|NCT01023022|Secondary|Efficiency Through Increased Flexibility and Per Procedure Time||Baseline to max. 12 months||||||
807408|NCT01023022|Secondary|Time and Costs Savings for Physicians||Baseline to max. 12 months||||||
807409|NCT01023022|Secondary|Time and Cost Savings for Patients||Baseline to max. 12 months||||||
807410|NCT01023022|Secondary|Clinic-specific Clinical Value of Medtronic CareLink® Network (Change of Workflow, Increase of Flexibility)||Baseline to max. 12 months||||||
807411|NCT01023022|Secondary|Clinician Ease of Use of, and Satisfaction With, the Medtronic CareLink® Monitor and Website (Including Clinician General Preference, if Any, for Medtronic CareLink® Compared to Traditional In-clinic Device Follow-up)||Baseline to max. 12 months||||||
807412|NCT01023022|Secondary|Patient Ease of Use of, and Satisfaction With the Medtronic CareLink® Monitor (Including Percentage of Patients Who Prefer Follow up With Medtronic CareLink® Compared to Traditional In-clinic Device Follow-up)|"Participants were asked questions to which they could have respond multiple answers. 1) Which form of device follow up do you prefer? Answers: Monitor from home and in hospital follow up is necessary; Follow up only in hospital; No preference, and 2) How would you judge the user friendliness of the monitor in total? Answers: Very easy; Easy; Difficult; Missing Data, and 3) How did the monitor changed your daily life? did you felt more or less safe? Answers: Much more safe; Safe; No influence; Unsafe; Missing data"|Baseline to max. 12 months|Number of patients who provided responses for these questions at the end of the Study.||percentage of patients|||Number
807413|NCT01023022|Primary|Comparison of Remote Device Check and In-clinic Device Assessment|"Investigators were asked the following question: how did the Medtronic CareLink system matched their personal expectation/goals and had to answer with multiple answer using the following ranking Significantly exceeded, Goals met, No expectations, Not met, Not met at all: Question 1) Newest technology for my patients. Q2) Increased patient safety. Q3) Increased patient satisfaction. Q4) Improved quality of life for my patients. Q5) Improved follow up after therapy/shock delivery of for symptomatic patients, adverse events. Q6) Increased hospital efficiency. Q7) Increased follow up quality. Q8) More flexible follow up schemes possible. Q9) Better management of the increased number of follow ups. Q10) Increased satisfaction of hospital personnel. Q11) Other goals"|Baseline to max. 12 months|Number of Investigators who provided responded for these questions at the end of evaluation.||percentage of Investigators|||Number
807414|NCT01023035|Secondary|Percentage of Participants Who Discontinued Treatment|Cumulative discontinuation was defined as the sum of discontinuations due to adverse events, viral breakthrough/resistance, detectable HCV-RNA and futility rules (<2-log10 decline in HCV-RNA at Treatment Week 12, ≥ Lower Limit of Quantification [LLQ] HCV-RNA at Treatment Week 24), and other (noncompliance, withdrawal of consent, lost to follow-up).|From Study Day 1 up to Study Treatment Week 48|All Treated Participants, defined as all participants who were treated with any study medication.||percentage of participants||95% Confidence Interval|Number
807415|NCT01023035|Primary|Percentage of Participants With Sustained Virologic Response (SVR)|SVR was defined as undetectable plasma Hepatitis C Virus ribonucleic acid (HCV-RNA) at Follow-up Week 24|At Follow-up Week 24|The primary efficacy analysis was performed on all participants who were randomized to either the RBV Dose Reduction Arm or the EPO Use Arm for anemia management (i.e. the Full Analysis Set of patients requiring anemia management [FAS, n=500]).||percentage of participants|||Number
807416|NCT01023061|Secondary|Median Time to Prostate Specific Antigen Progression|Defined as the date of an increase of 2ng/mL or more above the Prostate specific antigen nadir achieved after completion of radiation with the date of progression defined as the date on which that value was measured. Distribution of time-to-event variables will be estimated using the Kaplan-Meier product-limit method. Estimated with two-sided 95% confidence intervals.|6 months|Treated patients||years||Standard Deviation|Mean
807417|NCT01023061|Primary|Levels of Dihydrotestosterone (DHT) and Testosterone in Prostate Biopsy Sample Assessed by Mass Spectrometry|The levels from patients treated in this study will be compared to a control set of biopsies acquired from a separate but similar population of men with intermediate and high risk prostate cancer treated with three months of combined Luteinizing hormone releasing hormone agonist and bicalutamide as part of standard of care.|Week 12|Treated patients with measurable tissue DHT||pg/mg||90% Confidence Interval|Median
807434|NCT01023256|Secondary|Change From Baseline in Mean Disease Activity Score-28 Joints (DAS28) at 4 Weeks|The primary exploratory efficacy outcome was change from baseline in Disease Activity Score calculated using 28 joints (DAS28) and the erythrocyte sedimentation rate (ESR) as the acute phase reactant (0 = no disease activity; 9.3 = maximal disease activity).|Change from baseline to week 4 (1 week after last MOR103 dose)|All treated patients||units on a scale||Standard Deviation|Mean
807418|NCT01023061|Primary|Incidence of Acute and Chronic Grade 3 or Greater Toxicity as Evaluated Using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0|Incidence of acute and chronic grade 3 or greater toxicity as evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0he distribution of time to late adverse events (observed severities of adverse events over time) will be estimated using the Kaplan-Meier method.|Up to 24 months after initiation of radiation therapy|Treated patients||Participants|||Count of Participants
807419|NCT01023074|Secondary|SCAN-A: Competing Words Test|The SCAN-A: Competing Words Test assesses participants' auditory processing abilities via a dichotic listening task. Lists of word pairs are presented separately to each ear, and participants repeat the words they hear. Possible range of scores = 0-20, with higher scores indicating better performance.|Test administered during one session|||units on a scale||Standard Deviation|Mean
807420|NCT01023074|Secondary|Neural Magnetic Resonance Imaging (MRI)|Gray matter volume|Results were recorded during one scanning session|Data reported for 47 study participants who underwent MRI||cubic cm||Standard Deviation|Mean
807421|NCT01023074|Primary|Electrophysiological Auditory Test|"auditory P300 amplitude in response to rare 1000 Hz tones"|Recordings were conducted during one session|||microvolts||Standard Deviation|Mean
807422|NCT01023178|Primary|Estradiol|Estradiol blood levels at end of study compared across groups to determine effect of dosing methods. Significance of levels depends on the stage of puberty and goals of therapy.|end of study (up to 2 years)|||pg/mL||Standard Error|Mean
807423|NCT01023217|Secondary|Complete Virologic Response (CVR, Serum HBV DNA Undetectable by PCR or Less Than 60 IU/mL)||at week 104 from randomization||||||
807424|NCT01023217|Secondary|Normalization of ALT Level||at week 52 and at week 104 from randomization||||||
807425|NCT01023217|Secondary|Genotypic Resistance to ADV or ETV||at week 52 and at week 104 from randomization||||||
807426|NCT01023217|Secondary|Reduction in Serum HBV DNA Levels||at week 52 and at week 104 from randomization||||||
807427|NCT01023217|Primary|Complete Virologic Response (CVR, Serum HBV DNA Undetectable by PCR or Less Than 60 IU/mL)||at week 52 from randomization|||participants|||Number
807428|NCT01023256|Other Pre-specified|Change From Screening in Outcome Measures in Rheumatology (OMERACT)-Rheumatoid Arthritis Magnetic Resonance Imaging Studies Mean Sum Score for Synovitis at Week 8|Magnetic resonance imaging (MRI) was performed on the wrist and hand on the side with the most swollen joints (or the right side if swollen joints were equivalent). The 2nd to 5th metacarpophalangeal joints and 3 wrist joints (distal radioulnar, radiocarpal, and intercarpal-carpometacarpal joints) were scored on a scale of 0 = no synovitis to 3 = severe synovitis. MRIs were scored by 2 independent experts blinded to patient data and chronology. The sum score is the average of the 2 reader scores for each of the 7 joints. The range of the sum score is thus 0 = no synovitis in any joint to 21 = severe synovitis in all joints.|Change from screening to week 8|At week 8, MRI data were not available for 6 placebo patients, 5 MOR103 0.3 mg/kg patients, 1 MOR103 1.0 mg/kg patient, and 2 MOR103 1.5 mg/kg patients.||units on a scale||Standard Deviation|Mean
807429|NCT01023256|Secondary|Change From Baseline in Patient-reported Outcomes at Weeks 4 and 8|Patient-reported outcomes included patient’s self-assessment of pain (measured on a 100 mm visual analogue scale [VAS] from 0 = best to 100 = worst), the Health Assessment Questionnaire-Disability Index (HAQ-DI; 0 = best to 3 = worst), the patient's global assessment of disease activity (measured on a 100 mm visual analogue scale [VAS] from 0 = best to 100 = worst), and fatigue, which was measured by the Functional Assessment of Chronic Illness Therapy (FACIT)-fatigue self-assessment scale (0 = worst; 52 = best).|Change from baseline at week 4 (1 week after last MOR103 dose) and change from baseline at week 8|All treated patients||units on a scale||Standard Deviation|Mean
807430|NCT01023256|Secondary|Change From Baseline in Mean Swollen and Tender Joint Counts at Weeks 4 and 8|Swollen joint counts were based on 66 joints and tender joint counts were based on 69 joints.|Change from baseline to week 4 (1 week after last MOR103 dose) and change from baseline to week 8|All treated patients||joints||Standard Deviation|Mean
807431|NCT01023256|Secondary|Percentages of Subjects With American College of Rheumatology 20% Improvement (ACR20) at Week 4|The percentage of patients achieving an ACR20 response (20% improvement based on ACR improvement criteria) in each group. ACR20 improvement criteria require at least 20% improvement in both swollen and tender joints counts and 3 out of 5 of the following parameters: pain visual analog scale, patient global assessment, physician global assessment, acute phase reactant (erythrocyte sedimentation rate or C-reactive protein), and functional questionnaire.|Week 4 (1 week after last MOR103 dose)|All participants were included in ACR response calculations. Patients lacking data required for calculation of an ACR response were considered as not having an ACR response. 1 patient in the MOR103 0.3 mg/kg group, 1 patient in the MOR103 1.0 mg/kg group, and 5 patients in the pooled placebo group had missing data for ACR calculations.||percentage of participants|||Number
807432|NCT01023256|Secondary|Change From Baseline in Mean Disease Activity Score-28 Joints (DAS28) at 8 Weeks|The primary exploratory efficacy outcome was change from baseline in Disease Activity Score calculated using 28 joints (DAS28) and the erythrocyte sedimentation rate (ESR) as the acute phase reactant (0 = no disease activity; 9.3 = maximal disease activity)|Change from baseline to week 8 (5 weeks after last MOR103 dose)|All treated patients||units on a scale||Standard Deviation|Mean
807433|NCT01023256|Other Pre-specified|Change From Screening in Outcome Measures in Rheumatology (OMERACT)-Rheumatoid Arthritis Magnetic Resonance Imaging Studies Mean Sum Score for Synovitis at Week 4|Magnetic resonance imaging (MRI) was performed on the wrist and hand on the side with the most swollen joints (or the right side if swollen joints were equivalent). The 2nd to 5th metacarpophalangeal joints and 3 wrist joints (distal radioulnar, radiocarpal, and intercarpal-carpometacarpal joints) were scored on a scale of 0 = no synovitis to 3 = severe synovitis. MRIs were scored by 2 independent experts blinded to patient data and chronology. The sum score is the average of the 2 reader scores for each of the 7 joints. The range of the sum score is thus 0 = no synovitis in any joint to 21 = severe synovitis in all joints.|Change from screening to week 4 (1 week after last MOR103 dose)|At week 4, MRI data were not available for 5 placebo patients, 2 MOR103 0.3 mg/kg patients, 2 MOR103 1.0 mg/kg patients, and 1 MOR103 1.5 mg/kg patient.||units on a scale||Standard Deviation|Mean
808054|NCT01019694|Secondary|Change From Baseline in FVC at Day 1|Change from test-day baseline in Forced Vital Capacity (FVC) at 1 hour post dose on test day 1.|baseline, day 1|Treated Set is defined as all patients who were randomized and received study drug||liters||Standard Error|Least Squares Mean
807435|NCT01023256|Primary|Percentages of Patients With Treatment-emergent or Serious Adverse Events|Data on treatment-emergent adverse events (MedDRA version 13.0) were collected at each visit (weeks 1, 2, 3, 4, 5, 6, 8, 10, 13, and 16). For a list of serious adverse events and adverse events occurring at a frequency of >5 % (>1 patient) in any treatment group, please see the adverse events listing.|From the first dose through the 16-week visit|All patients who received treatment.||percentage of participants|||Number
807436|NCT01023308|Secondary|Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System : FACT/GOG-NTX-Change From Baseline by Treatment Group|Chronic Illness Therapy (FACIT) Measurement System and focuses on four general quality of life domains for physical well being, functional well-being, social/family well-being, and emotional well-being, and includes additional items to characterize treatment-related neurotoxicity. Higher subscales/total scores represent higher QOL. In the case of the neurotoxicity subscale, lower scores correspond to higher neurotoxicity. The recall period referenced in the questionnaire is the past 7 days.Ranges for FACT-G subscales are as follows:.PWB, scale 0 -28, , NtxS scale 0-44, FACT/GOG-Ntx trial outcome index scale is 0-100 and FACT-G scale is also scaled 0-100. An increase from baseline in these scores indicate improvement.|12, 24 and 48 weeks|Full Analysis Set||score on a scale||95% Confidence Interval|Least Squares Mean
807437|NCT01023308|Secondary|European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group|"The EORTC QLQ-C30 measures functional dimensions (physical, role, emotional, cognitive, and social), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), six single-item symptom scales (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea and financial impact) and a global health status/QoL scale. Disease Symptom is the sum of 30 questions, total score ranges from 0 (best possible outcome) to 100 (worst possible outcome), All subscales of EORTC QLQ-C30 have the same score range of 0 -100. For global health status and other functional scales,an increase from baseline indicates improvement of QoL. Whereas for symptoms scales, fatigue, dyspnea, insomnia, appetite loss, constipation and diarrhea, decrease in scores from baseline indicate improvement in symptoms."|12, 24 and 48 weeks|Full Analysis Set||score on a scale||95% Confidence Interval|Least Squares Mean
807438|NCT01023308|Secondary|European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC) QLQ-MY20-Change From Baseline by Treatment Group|"Higher values in the disease symptoms and side effects of treatment scores indicate worsening. Higher scores in the future perspective and body image scores indicate improvement. LS Means and SEM are estimated from the repeated measures model. Following factors and covariates are included in the repeated measurement model: time, treatment, treatment by time interaction, number of prior lines of anti-MM therapy (1/ 2 and 3), prior use of BTZ (Yes/ No), baseline score.Disease Symptom is the sum of 20 questions, total score ranges from 0 (best possible outcome) to 100 (worst possible outcome), All subscales of EORTC QLQ-MY20 have the same score range of 0 -100. Decrease in symptom scores from baseline indicate improvement in symptoms."|12, 24 and 48 weeks|Full Analysis Set||score on a scale||95% Confidence Interval|Least Squares Mean
807439|NCT01023308|Secondary|Time to Progression/Relapse Per Investigator Assessment (mEBMT Criteria) Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.||45 months|||months||95% Confidence Interval|Median
807440|NCT01023308|Secondary|Duration of Response Per Investigator Assessment (mEBMT Criteria) Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.||45 months|||duration of response in months||95% Confidence Interval|Median
807441|NCT01023308|Secondary|Time to Response Per Investigator Assessment (mEBMT Criteria) of Response Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.||45 months|||time to response in months||95% Confidence Interval|Median
807442|NCT01023308|Secondary|Overall Response Rate in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.|Best overall response based on mEBMT criteria per investigator assessment|45 months|||% participants with response|||Number
807443|NCT01023308|Secondary|Overall Survival in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone|survival time in months|45 months|FAS||months||95% Confidence Interval|Median
807444|NCT01023308|Secondary|Overall Survival in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone|Number of OS events|45 months|||Number of OS events|||Number
807445|NCT01023308|Primary|Progression Free Survival in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.||45 months|Full Analysis Set||months||95% Confidence Interval|Median
807446|NCT01023308|Primary|Progression-free Survival Events in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.||45 months|||number of events|||Number
807447|NCT01023516|Secondary|Exacerbations - Clinic Defined|Number of patients having a clinic defined disease exacerbation.|Duration of the the treatment period - 12 weeks|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||Participants|||Number
807448|NCT01023516|Secondary|St George's Respiratory Questionnaire (COPD) - End-value Overall Score|St George's Respiratory Questionnaire for Chronic Obstructive Pulmonary Disease, as a measure of Quality of Life (reported on a scale from 0 (best health status) to 100(worst possible status)).Questionaire assessed on vist 6 -( last on treatment clinic visit)|Measured Day 1 and 12 weeks|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||Scores on a scale||Standard Error|Least Squares Mean
817590|NCT01112579|Secondary|Characterize the Change in Peak Oxygen Uptake Between the Treatment Arm and Control Arm Through 6 Months||Baseline and 6 Months|||mL/kg/min||Standard Deviation|Mean
807449|NCT01023516|Secondary|St George's Respiratory Questionnaire (COPD) - Overall Score at Baseline|St George's Respiratory Questionnaire for Chronic Obstructive Pulmonary Disease, as a measure of Quality of Life (reported on a scale from 0 (best health status) to 100(worst possible status)).|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||Scores on a scale||Standard Deviation|Mean
807450|NCT01023516|Secondary|Endurance Shuttle Walk Test - End Value|Assessed at vist 6 -( last on treatment clinic visit)|Week 12 - visit 6|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||seconds||Standard Error|Least Squares Mean
807451|NCT01023516|Secondary|Endurance Shuttle Walk Test - Baseline|Endurance time (s)|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||seconds||Standard Deviation|Mean
807452|NCT01023516|Secondary|Incremental Shuttle Walk Test - End Value||Week 12 - visit 6|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||seconds||Standard Error|Least Squares Mean
807453|NCT01023516|Secondary|Incremental Shuttle Walk Test - Baseline|Endurance time (s)|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||seconds||Standard Deviation|Mean
807454|NCT01023516|Secondary|Use of Reliever Medication|Daily average of number of inhalations of reliever medication|Last 6 weeks on treatment|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||inhalations||Standard Error|Least Squares Mean
807455|NCT01023516|Secondary|Sputum Colour - End Value|Sputum Colour as assessed by the Bronkotest scale, reported on a scale from 1 - clear (best health status) to 5 - dark green (worst possible health status). End of treatment week 12|End of treatment week 12|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||units on a scale||Standard Error|Least Squares Mean
807456|NCT01023516|Secondary|Sputum Colour - Baseline|Sputum Colour as assessed by the Bronkotest scale, reported on a scale from 1 - clear (best health status) to 5 - dark green (worst possible health status).|Baseline|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||units on a scale||Standard Deviation|Mean
807457|NCT01023516|Secondary|BCSS - End-value Total Score|Breathlessness, Cough and Sputum Scale, patient reported questionnaire as a measure of respiratory symptoms (reported on a 0 (best health status) to 12 (worst possible status) scale).|Last 6 weeks on treatment|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||units on a scale||Standard Error|Least Squares Mean
807458|NCT01023516|Secondary|BCSS - Baseline Total Score|Breathlessness, Cough and Sputum Scale, patient reported questionnaire as a measure of respiratory symptoms (reported on a 0 (best health status) to 12 (worst possible status) scale). Baseline is the mean of last 10 days of data before start of treatment.|Baseline|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||units on a scale||Standard Deviation|Mean
807459|NCT01023516|Secondary|EXACT - End-value Total Score|EXAcerbations of Chronic pulmonary disease Tool, patient questionnaire as a measure of respiratory symptoms (reported as units on a 0 (best health status) to 100 (worst possible status) scale).|Last 6 weeks on treatment|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||units on a scale||Standard Error|Least Squares Mean
807460|NCT01023516|Secondary|EXACT - Baseline Total Score|EXAcerbations of Chronic pulmonary disease Tool, patient questionnaire as a measure of respiratory symptoms (reported as units on a 0 (best health status) to 100 (worst possible status) scale). Baseline is the mean of last 10 days of data before start of treatment.|Baseline|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||units on a scale||Standard Deviation|Mean
808055|NCT01019694|Secondary|Change From Baseline in FEV1 at Week 48|Change from test-day baseline in Forced Expiratory Volume in 1 second (FEV1) at 1 hour post dose at Week 48|baseline, 48 weeks|Treated Set is defined as all patients who were randomized and received study drug||liters||Standard Error|Least Squares Mean
807461|NCT01023516|Secondary|FEV1 - End-value Measured by Patient at Home (L) in the Morning|Forced Expiratory Volume in 1 second (L)|Last 6 weeks on treatment|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Error|Least Squares Mean
807462|NCT01023516|Secondary|FEV1 - Baseline Measured by Patient at Home (L) in the Morning|Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured at home by the patient each morning. Baseline is the mean of last 10 days of data before start of treatment.|Baseline|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Deviation|Mean
807463|NCT01023516|Secondary|PEF - End-value Measured by Patient at Home (L/Min) in the Morning|Peak expiratory flow (PEF)|Last 6 weeks on treatment|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L/min||Standard Error|Least Squares Mean
807464|NCT01023516|Secondary|PEF - Baseline Measured by Patient at Home (L/Min) in the Morning|Peak Expiratory Flow (L/min) as a measure of lung function, measured at home by the patient each morning. Baseline is the mean of last 10 days of data before start of treatment.|Baseline|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L/min||Standard Deviation|Mean
807465|NCT01023516|Secondary|Post-bronchodilator IC (L) - End-value|End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)|up to week 12|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Error|Least Squares Mean
807466|NCT01023516|Secondary|Post-bronchodilator IC (L) - Baseline|Inspiratory capacity (IC) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic.|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Deviation|Mean
807467|NCT01023516|Secondary|Pre-bronchodilator IC (L) - End-value|End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)|up to week 12|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Error|Least Squares Mean
807468|NCT01023516|Secondary|Pre-bronchodilator IC (L) - Baseline|Inspiratory capacity (IC) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic.|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Deviation|Mean
807469|NCT01023516|Secondary|End-value Post-bronchodilator FEF25-75% (L/Sec)|End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)|up to week 12|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L/sec||Standard Error|Least Squares Mean
807470|NCT01023516|Secondary|Baseline Post-bronchodilator FEF25-75% (L/Sec)|Forced expiratory flow between 25% to 75% of vital capacity (FEF25-75%) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic.|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L/sec||Standard Deviation|Mean
807471|NCT01023516|Secondary|End-value Pre-bronchodilator FEF25-75% (L/Sec)|End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)|up to week 12|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L/sec||Standard Error|Least Squares Mean
807472|NCT01023516|Secondary|Baseline Pre-bronchodilator FEF25-75% (L/Sec)|Forced expiratory flow between 25% to 75% of vital capacity (FEF25-75%) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic.|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L/sec||Standard Deviation|Mean
807473|NCT01023516|Secondary|End-value Post-bronchodilator FEV6 (L)|End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)|up to week 12|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Error|Least Squares Mean
807474|NCT01023516|Secondary|Baseline Post-bronchodilator FEV6 (L)|Forced expiratory volume in 6 seconds (FEV6) as a measure of lung function, measured post after bronchodilator (salbutamol) use in the clinic.|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Deviation|Mean
807475|NCT01023516|Secondary|End-value Pre-bronchodilator FEV6 (L)|End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)|up to week 12|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Error|Least Squares Mean
807476|NCT01023516|Secondary|Baseline Pre-bronchodilator FEV6 (L)|Forced expiratory volume in 6 seconds (FEV6) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic.|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Deviation|Mean
807477|NCT01023516|Secondary|Post-bronchodilator FVC (L) - End-value|End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)|up to week 12|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Error|Least Squares Mean
807478|NCT01023516|Secondary|Post-bronchodilator FVC (L) - Baseline|Forced vital capacity (FVC) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic.|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Deviation|Mean
807479|NCT01023516|Secondary|Pre-bronchodilator FVC (L) - End-value|End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)|up to week 12|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Error|Least Squares Mean
807480|NCT01023516|Secondary|Pre-bronchodilator FVC (L) - Baseline|Forced vital capacity (FVC) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic.|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Deviation|Mean
807481|NCT01023516|Secondary|Post-bronchodilator FEV1 (L) - End-value|End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)|up to week 12|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Error|Least Squares Mean
807482|NCT01023516|Secondary|Post-bronchodilator FEV1 (L) - Baseline|Forced expiratory volume in 1 second (FEV1) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic.|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Deviation|Mean
807483|NCT01023516|Primary|End-value Pre-bronchodilator FEV1 (L)|End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)|up to week 12|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Error|Least Squares Mean
807484|NCT01023516|Primary|Baseline Pre-bronchodilator FEV1 (L)|Forced expiratory volume in 1 second (FEV1) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic.|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Deviation|Mean
807485|NCT01023568|Secondary|Number of Participants Who Experienced Desaturation|Desaturation was defined as SpO2 less than 90% at induction time or any time from intubation to 10 minutes after|measured at 1 minute interval at induction time and from intubation for 10 minutes.|||participants|||Number
807486|NCT01023568|Secondary|Mean Hemodynamic Response: Heart Rate||measured at 1 minute interval at induction time and from intubation for 10 minutes.|||beats/min||Standard Deviation|Mean
807487|NCT01023568|Secondary|Cormack-Lehane Grade||immediately after intubation|||participants|||Number
807488|NCT01023568|Secondary|Mean Hemodynamic Response: Mean Arterial Blood Pressure||measured at 1 minute interval at induction time and from intubation for 10 minutes|||mmHg||Standard Deviation|Mean
807489|NCT01023568|Primary|Time to Successfully Intubate Patient.||from start of intubation to successfully intubated up to 5 minutes|||seconds||Inter-Quartile Range|Median
808056|NCT01019694|Secondary|Change From Baseline in FEV1 at Week 24|Change from test-day baseline in Forced Expiratory Volume in 1 second (FEV1) at 1 hour post dose at Week 24|baseline, 24 weeks|Treated Set is defined as all patients who were randomized and received study drug||liters||Standard Error|Least Squares Mean
807490|NCT01023581|Secondary|Change From Baseline in Fasting Plasma Glucose Over Time|The change from Baseline in fasting plasma glucose was assessed at Weeks 1, 2, 4, 8, 12, 16, 20 and 26. Least Squares Means were from an ANCOVA model with treatment and geographic region as fixed effects, and baseline fasting plasma glucose as a covariate.|Baseline and Weeks 1, 2, 4, 8, 12, 16, 20 and 26.|Full analysis set where a baseline assessment and at least 1 valid postbaseline assessment were available. Includes only data collected on or after baseline and within 1 day after the last dose of study medication or hyperglycemic rescue, whichever came first. Last observation carried forward was utilized.||mg/dL||Standard Error|Least Squares Mean
807491|NCT01023581|Secondary|Change From Baseline in HbA1c Over Time|"The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) was assessed at Weeks 4, 8, 12, 16 and 20.
Least squares means are from an analysis of covariance (ANCOVA) model with treatment and geographic region as fixed effects, and baseline HbA1c as a covariate."|Baseline and Weeks 4, 8, 12, 16, and 20.|The full analysis set where a baseline assessment and at least 1 valid postbaseline assessment were available. The analysis includes only data collected on or after baseline and within 7 days after the last dose of study medication or hyperglycemic rescue, whichever came first. Last observation carried forward was utilized.||percentage glycosylated hemoglobin||Standard Error|Least Squares Mean
807492|NCT01023581|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26|The change from Baseline to Week 26 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound).|Baseline and Week 26.|Full analysis set (patients who took at least 1 dose of study medication) where baseline and at least 1 postbaseline assessment were available. Analysis includes only data collected on or after baseline and within 7 days after last dose of study medication or hyperglycemic rescue, whichever came first. Last observation carried forward was utilized.||percentage glycosylated hemoglobin||Standard Error|Least Squares Mean
807493|NCT01023659|Primary|Proportion of Eligible Participants Who Were Able to Attend an Appointment With a Physician|Proportion of eligible participants who were able to attend an appointment with a physician to have the prescription signed|End of Treatment|total number of eligible participants in study||Participants|||Count of Participants
807494|NCT01023659|Primary|7-day Point Prevalence of Abstinence|"7-day point prevalence of abstinence was assessed by the question Have you had a cigarette, even a puff, in the past 7 days?"|6-month|Number of eligible participants who either received bupropion + motivational emails, varenicline + motivational emails or motivational emails alone (because they either did not attend a physician visit or their physician decided not to prescribe them bupropion or varenicline)||Participants|||Count of Participants
807495|NCT01023672|Primary|Mean Initial Sleep Latency as Measured by the Maintenance of Wakefulness Test (MWT)|"The MWT measures the subject's ability to stay awake while sitting quietly in a chair. The test has 4 parts, each lasting 40 minutes if the subject is able to remain awake that long each time, and the parts are spaced apart in 2 hour intervals through the day.
The subject is placed in a dim room, with the only source of light slightly behind the subject's head and out of his/her field of vision, and back and neck supported. During this time the subject is monitored with the same measures that are used in a standard overnight sleep study called a polysomnogram. The sleep latency, or time it takes the subject to fall asleep, will be recorded.
In healthy people, the time it takes to fall asleep may be approximately 30 minutes on the test. More than 97% of people will take eight minutes or longer to fall asleep. Therefore, sleep latency that is less than eight minutes is considered to be abnormal."|baseline, 12 weeks|Per Protocol; 3 subjects did not complete the study (2 had worsening disease, and 1 died) and did not complete this test.||minutes||Inter-Quartile Range|Median
807496|NCT01023711|Secondary|Assessment of the Reactogenicity Events Post Vaccination.|Number of subjects with reactogenicity events of grade 2 or higher within 7 days of vaccination|7 days|Subjects who completed the 7 day diary card||participants|||Number
807497|NCT01023711|Primary|Determination of Immune Response to Vaccination.|Number of participants with a 4-fold or greater increase in serum HAI antibody from pre- to 28 day post-vaccination|28 days|All subjects who completed Day 28 visit post vaccination were analyzed.||participants|||Number
807498|NCT01023724|Primary|Anterior Chamber Inflammation (Flare)|Anterior chamber flare measured by assessing the number of inflammatory cells in the anterior chamber.|Day 14 of treatment|||photon count per msec (pc/ms)||Standard Deviation|Mean
807499|NCT01023776|Secondary|Mean Difference Between Cycle Time and Detection Threshold|The mean difference was calculated by real-time polymerase chain reaction (PCR) on nasal wash samples. Cycle time is the cycle number at which the PCR reaction is positive with a range of 0-40 cycles. The detection threshold is 40 cycles.|day 10 post vaccine 1|per protocol||cycles||95% Confidence Interval|Mean
807500|NCT01023776|Primary|Number of Participants Who Shed Virus|number of participants who shed virus above the limit of detection at any timepoint after vaccine. The limit of detection is 0.5 tissue culture infectious doses per mL of nasal wash.|28 days post vaccine 1 and 28 days vaccine 2|per protocol||participants|||Number
807501|NCT01023815|Secondary|Change in Serum Creatinine|Serum creatinine (a blood measurement) is an important indicator of renal health because it is an easily-measured by-product of muscle metabolism. Measuring serum creatinine is a simple test and it is the most commonly used indicator of renal function.|M3, M12|ITT population, defined as all randomized patients who received at least one dose of study drug after Visit 5 (Day 90) and have at least one post-baseline assessment of the primary efficacy variable (i.e. treatment failure).||mg/dL||Standard Deviation|Mean
807502|NCT01023815|Secondary|Change in Estimated Creatine Clearance|At each visit, estimated creatinine clearance was measured in the local laboratory to analyze the evolution of the renal function. The following indirect measures of renal function were computed: estimated creatinine clearance according to Cockcroft and Gault formula and MDRD formula.|M3, M12|ITT population, defined as all randomized patients who received at least one dose of study drug after Visit 5 (Day 90) and have at least one post-baseline assessment of the primary efficacy variable (i.e. treatment failure).||mL/min||Standard Deviation|Mean
807516|NCT01024036|Secondary|Percentage of Participants Who Discontinued Corticosteroids|Percentage of participants who discontinued corticosteroids during blinded treatment period and who were dependent on corticosteroids at baseline (Day 1 of Cycle 1).|From Day 1 of Cycle 1 until 48 weeks after the after the last participant started study treatment|All randomized participants who were dependent on corticosteroids at baseline||Percentage of participants|||Number
807503|NCT01023815|Secondary|Number of Participants With Graft and Patient Survival After Randomization|"Graft Survival, calculated from the date of transplantation to the date of irreversible graft failure signified by return to long‐term retransplantation or the date of the last follow‐up during the period when the transplant was still functioning or to the date of death.
Patient survival, calculated from the date of transplantation to the date of death or the date of the last follow‐up."|Month 3 to Month 12|ITT population, defined as all randomized patients who received at least one dose of study drug after Visit 5 (Day 90) and have at least one post-baseline assessment of the primary efficacy variable (i.e. treatment failure).||Participants|||Number
807504|NCT01023815|Secondary|Biopsy Proven Acute Rejection (BPAR) Rate Between Randomization and Month 12|"Occurrence of BPAR (after randomization) between arm B (steroid withdrawal group) and arm c (standard twice-a-day group).
BPAR was defined as a biopsy graded IA, IB, IIA, IIB, or III according to Banff 1997 grading with 2007 update."|Month 3 to Month 12|ITT population, defined as all randomized patients who received at least one dose of study drug after Visit 5 (Day 90) and have at least one post-baseline assessment of the primary efficacy variable (i.e. treatment failure).||Participants|||Number
807505|NCT01023815|Secondary|Changes in the Estimated Glomerular Filtration Rate (eGFR) Between Randomization (Month 3) and Month 12|eGFR by Nankivell, in terms of descriptive statistics and change vs randomization visit - to compare the changes in the estimated GFR (Nankivell) between randomization and Month 12 in the steroid withdrawal group (Group B) to the change observed in the standard twice-a-day group (Group C), for non-inferiority|Month 3 to Month 12|ITT population, defined as all randomized patients who received at least one dose of study drug after Visit 5 (Day 90) and have at least one post-baseline assessment of the primary efficacy variable (i.e. treatment failure).||mL/min||Standard Deviation|Mean
807506|NCT01023815|Primary|Treatment Failure Rate|Occurrence or not of treatment failure in each patient. Treatment failure was defined as a composite endpoint of biopsy-proven acute rejection (a biopsy graded IA, IB, IIA, IIB or III according to Banff ’97 grading with 2007 update), graft loss, death or lost to follow-up occurring after randomization (V5) and within M12 (V9).|Between randomization (Month 3) and Month 12|ITT population: all randomized pts who received at least one dose of study drug after Visit 5 & have at least one post-baseline assessment of the primary efficacy variable. Change in study design stopped the randomization into Group A, due to overall slow enrollment rate & shifted all relative objectives to exploratory, due to small sample size.||Participants|||Number
807507|NCT01023841|Primary|Percentage of Participants With at Least a 1-Grade Improvement From Baseline in the Global Eyebrow Assessment (GEA) Score|The physician evaluated the overall eyelash prominence in both eyes using the GEA 4-point scale: 1= minimal, 2= moderate, 3= marked and 4= very marked. A 1-grade improvement in the GEA score from Baseline indicated improvement.|Baseline, Month 4|Intent-to-treat population included all randomized participants.||Percentage of participants|||Number
807508|NCT01023841|Secondary|Change From Baseline in Upper Eyelash Darkness as Measured by DIA|Photographs were taken of the eyelashes and assessed using DIA. Eyelash darkness (intensity) was measured in both eyes and averaged for analysis using a scale where 0=black and 255=white. A negative change from Baseline indicated darker eyelashes (improvement).|Baseline, Month 4|Participants from the Intent-to-treat population, that included all randomized participants, with data available at Baseline and Month 4.||Intensity units||Standard Deviation|Mean
807509|NCT01023841|Secondary|Change From Baseline in Upper Eyelash Thickness as Measured by DIA|Photographs were taken of the eyelashes and assessed using DIA. Eyelash thickness (fullness) was assessed across both eyes as an average and is measured in millimeters squared (mm^2). A positive change from Baseline indicated fuller eyelashes (improvement).|Baseline, Month 4|Participants from the Intent-to-treat population, that included all randomized participants, with data available at Baseline and Month 4.||mm^2||Standard Deviation|Mean
807510|NCT01023841|Secondary|Change From Baseline Upper Eyelash Length as Measured by Digital Image Analysis (DIA)|Photographs were taken of the eyelashes and assessed using DIA. Length was measured in millimeters (mm). Data from both eyes were averaged for each participant for analysis. A positive change from Baseline indicated longer length (improvement).|Baseline, Month 4|Intent-to-treat population included all randomized participants.||mm||Standard Deviation|Mean
807511|NCT01023841|Primary|Percentage of Participants With Adverse Events|An adverse event was any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.|5 Months|Safety population included all randomized participants who received treatment.||Percentage of participants|||Number
807512|NCT01024036|Secondary|Median Time Required to Achieve >=5-point Increase in the Short-Form-36 (SF-36) Physical Component Summary (PCS) Scores From Baseline|SF-36 is a questionnaire and PCS is a part of subscle assessing physical functioning, role-physical, bodily pain, and general health. The scores range from 0 (worst score) to 100 (best score), with a higher score indicating better quality of life.|From Day 1 of Cycle 1 (baseline) until 48 weeks after the last participant started study treatment|Intent-to-treat (ITT) population: all randomized participants||Days||95% Confidence Interval|Median
807513|NCT01024036|Secondary|Median Time Required to Achieve >=3-point Increase in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scores From Baseline|The FACIT-F, a 13-item instrument, was designed to measure patient-reported fatigue. It is one of the suite of FACIT instruments developed for outcomes in cancer. Concepts measured in the scale include tiredness, weakness, and difficulty conducting usual functional activities or social interaction due to fatigue. Response options range from “not at all” (0) to “very much” (4), and yield a summary score. Total FACIT-F score is the sum of 13 items, ranging from 0 (not at all) to 52 (very much). Higher scores represent better outcomes.|From Day 1 of Cycle 1 (baseline) until 48 weeks after the last participant started study treatment|Intent-to-treat (ITT) population: all randomized participants||Days||95% Confidence Interval|Median
807514|NCT01024036|Secondary|Median Time Required to Achieve >=1 Point Decrease in the Multicentric Castleman’s Disease Symptom Scale (MCD-SS) Score From Baseline|A patient-reported symptom scale. Symptom presence/absence and severity are noted on an anchor-based numeric scale. Scores range from 1 (very mild) to 5 (very severe).|From Day 1 of Cycle 1 (baseline) until 48 weeks after the last participant started study treatment|Intent-to-treat (ITT) population: all randomized participants||Days||Full Range|Median
807515|NCT01024036|Secondary|1-year Survival Rate||1 year|Intent-to-treat (ITT) population: all randomized participants||Percentage of participants|||Number
807517|NCT01024036|Secondary|Percentage of Participants Who Achieved >= 20 g/L Hemoglobin at Week 13 (Hemoglobin Response Rate)||Week 13|Hemoglobin response-evaluable population: participants who received at least 1 siltuximab/placebo administration and have a baseline hemoglobin that is below the lower limit of normal as per local laboratory specifications (within 2 weeks before starting treatment) and at least 1 post-baseline hemoglobin evaluation.||Percentage of participants|||Number
807518|NCT01024036|Secondary|Percentage of Participants Who Achieved >= 15 g/L Hemoglobin at Week 13 (Hemoglobin Response Rate)||Week 13|Hemoglobin response-evaluable population: participants who received at least 1 siltuximab/placebo administration and have a baseline hemoglobin that is below the lower limit of normal as per local laboratory specifications (within 2 weeks before starting treatment) and at least 1 postbaseline hemoglobin evaluation.||Percentage of participants|||Number
807519|NCT01024036|Secondary|Time to Treatment Failure|Time to treatment failure was defined as the time from randomization until the participant fails treatment. Treatment failure was defined as any of the following: a sustained increase from baseline in disease related symptoms >=Grade 2 persisting for at least 3 weeks despite best supportive care (BSC); onset of any new disease related Grade 3 or higher symptom despite BSC; sustained (ie, at least 3 weeks) deterioration in performance status (increase from baseline in Eastern Cooperative Oncology Group Performance Status by more than 1 point) despite BSC; radiologic progression, as measured by modified Cheson criteria; Initiation of any other therapy intended to treat multicentric Castleman’s disease ie, prohibited treatments. Statistical analysis shows difference in treatment failure rate (siltuximab+BSC minus Placebo+BSC).|From the date of randomization until a participant fails treatment, as assessed up to 48 weeks after the last participant started study treatment, whichever occurred earlier|Intent-to-treat (ITT) population: all randomized participants||Days||95% Confidence Interval|Median
807520|NCT01024036|Secondary|Median Duration of Tumor Response - by Independent Radiology Review|Duration of tumor response is defined as time from first documentation of tumor response to tumor progression. Tumour response is complete response (CR) + partial response (PR) as assessed according to Cheson criteria. CR: complete disappearance of all measurable and evaluable disease (eg, pleural effusion). PR: a >=50 percent decrease in sum of the product of the diameters of index lesion(s), with at least stable disease in all other evaluable disease. Statistical analysis shows difference of overall response rates (siltuximab+best supportive care [BSC] minus Placebo+BSC).|From the date when tumour response is achieved until tumour progression, as assessed up to 48 weeks after the last participant started study treatment|All randomized participants who achieved tumor response during blinded treatment period as per independent review||Days||Full Range|Median
807521|NCT01024036|Secondary|Percentage of Participants Who Achieved Complete Response (CR) + Partial Response (PR) (Tumor Response Rate) - by Independent Radiology Review|Overall tumor response is CR + PR assessed according to Cheson criteria. CR: complete disappearance of all measurable and evaluable disease (eg, pleural effusion). PR: a >=50 percent decrease in sum of the product of the diameters of index lesion(s), with at least stable disease in all other evaluable disease. Statistical analysis shows difference of overall response rates (siltuximab+best supportive care [BSC] minus Placebo+BSC).|From Day 1 of Cycle 1 until the date when durable tumour and symptomatic response is achieved, as assessed up to 48 weeks after the last participant started study treatment|Response-evaluable Population: included participants who received at least 1 administration of siltuximab/placebo and had at least 1 post-baseline radiologic disease evaluation||Percentage of participants|||Number
807522|NCT01024036|Secondary|Median Duration of Tumor and Symptomatic Response - by Independent Radiology Review|Duration of tumor and symptomatic response is defined as time from first documentation of tumor and symptomatic response (CR or PR) to treatment failure. Whenever possible, treatment failure documented by the appearance of new lesions should be confirmed by histologic examination of the new lesions. Symptomatic response is complete response (CR) + partial response (PR). CR: complete disappearance of all measurable and evaluable disease (eg, pleural effusion) and resolution of baseline symptoms attributed to multicentric Castleman’s disease, sustained for at least 18 weeks. PR: >=50 percent decrease in sum of the product of the diameters of indicator lesion(s), with at least stable disease in all other evaluable disease in the absence of treatment failure sustained for at least 18 weeks.|From the date when durable tumour and symptomatic response is achieved until treatment failure, as assessed until 48 weeks after the last participant started study treatment|All randomized participants who achieved durable tumor and symptomatic response during blinded treatment period as per independent review||Days||Full Range|Median
807523|NCT01024036|Primary|Percentage of Participants Who Achieved Durable Tumor and Symptomatic Response - by Independent Radiology Review|Durable tumor and symptomatic response is complete response (CR) + partial response (PR). CR: complete disappearance of all measurable and evaluable disease (eg, pleural effusion) and resolution of baseline symptoms attributed to multicentric Castleman’s disease, sustained for at least 18 weeks. PR: >=50 percent decrease in sum of the product of the diameters of indicator lesion(s), with at least stable disease in all other evaluable disease in the absence of treatment failure sustained for at least 18 weeks. The statistical analysis shows difference in symptomatic response rate (siltuximab+best supportive care [BSC] minus Placebo+BSC).|From Day 1 of Cycle 1 of treatment with study medication until treatment failure or discontinuation of treatment or withdrawal from the study, or up to 48 weeks after the last participant started study medication, whichever occurred earlier|Intent-to-treat (ITT) population: all randomized participants||Percentage of participants|||Number
807524|NCT01024244|Secondary|Change From Baseline in Heart Rate at 12 Weeks and 16 Weeks|Heart rate was measured in heartbeats per minute. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline, 12 weeks, 16 weeks|Data were reviewed but are not presented due to insufficient sample size.||beats per minute (bpm)||Standard Deviation|Mean
807534|NCT01024244|Secondary|Percentage of Participants Requiring Dose Adjustments During the 12-week Treatment Period|Percentage of participants who required dose adjustments at the discretion of the investigator for participants with persistent blood glucose<70 milligrams per deciliter (mg/dL). Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline through 12 weeks|Data were reviewed but are not presented due to insufficient sample size.||percentage of participants|||Number
807525|NCT01024244|Secondary|30-day Adjusted Rates of Self-reported Hypoglycemic Episodes Overall|Hypoglycemia: any time a participant experienced a sign/symptom associated with hypoglycemia or had blood glucose <70 milligrams per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]). The 30-day adjusted rate=(total number of episodes between 2 time intervals/number of days between intervals) X 30 days. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline through 16 weeks|Data were reviewed but are not presented due to insufficient sample size.||hypoglycemic episodes per 30 days|||Number
807526|NCT01024244|Secondary|Area Under the Concentration-time Curve (AUC) at a Dosing Interval (AUCtau) at the Steady State for LY2599506|The AUCtau values measure the area under the plasma concentration time curve at a dosing interval at steady state for LY2599506. Due to the nature of sparse sampling approach taken for the study AUC tau was estimated using the posthoc pharmacokinetic (PK) parameters obtained from population PK (PopPK) modeling. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Predose and 2 hours after dosing or predose and 4-12 hours after dosing in weeks 1, 2, 3, and 12|Data were reviewed but are not presented due to the insufficient sample size and sparse sampling approach.||nanograms per milliliter times hour||Standard Deviation|Mean
807527|NCT01024244|Secondary|Maximum Plasma Concentration (Cmax) at the Steady State for LY2599506|The Cmax value measures the maximum plasma concentration at steady state following administration of doses of LY2599506. Due to the nature of the sparse sampling approach, Cmax was estimated using the posthoc pharmacokinetic (PK) parameters obtained from population PK (PopPK) modeling. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Predose and 2 hours after dosing or predose and 4-12 hours after dosing in weeks 1, 2, 3, and 12|Data were reviewed but are not presented due to the insufficient sample size and the sparse sampling approach.||nanograms per deciliter (ng/dL)||Standard Deviation|Mean
807528|NCT01024244|Secondary|Mean Total Daily Dose of LY2599506 During the 12-week Treatment Period|The average total daily dose (sum of assigned morning and afternoon doses), in milligrams (mg), at each visit. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline through 12 weeks|No participants had data analyzed due to insufficient sample size.||milligrams (mg)||Standard Deviation|Mean
807529|NCT01024244|Secondary|Changes From Baseline in the Diabetes Symptoms Checklist-Revised (DSC-R) at 12 Weeks and 16 Weeks|Comprise 6 subscales (34 items). Each item score: 1 (not troublesome) to 5 (extremely troublesome) and transformed to 0-4 scale. Subscale score=sum of item scale in each subscale/total number of items. Global score=sum of scores by dimension. All scores standardized (0-100). Higher scores=greater symptom burden. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline, 12 weeks, 16 weeks|Quality of life data were not analyzed due to insufficient sample size.||units on a scale||Standard Deviation|Mean
807530|NCT01024244|Secondary|Change From Baseline in the Adult Low Blood Sugar Survey (LBSS-33 Item Scale) at 12 Weeks and 16 Weeks|Assesses 2 hypoglycemia domains, with each item score from 0 (never engages in behavior) to 4 (always engages in behavior): Behavioral (15 items; range 0-60) and Worry about hypoglycemia (18 items; range 0-72). Total score is the sum of both domains (range 0-132). Higher scores indicate greater negative impact. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall, and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading. As a result, this outcome measure was not analyzed.|Baseline, 12 weeks, 16 weeks|Quality of life data were not analyzed due to insufficient sample size.||units on a scale||Standard Deviation|Mean
807531|NCT01024244|Secondary|Change From Baseline in the Diabetes Treatment Satisfaction Questionnaire (DTSQ) at 12 Weeks and 16 Weeks|DTSQ, an 8-item questionnaire, measures satisfaction with treatment, perceived frequency of hyperglycemia, and perceived frequency of hypoglycemia. Response options range from 6 (best case) to 0 (worst case). Total scores for treatment satisfaction range from 0-36. Higher scores indicate higher satisfaction. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline, 12 weeks, 16 weeks|Quality of life data were not analyzed due to insufficient sample size.||units on a scale||Standard Deviation|Mean
807532|NCT01024244|Secondary|Percentage of Participants With Clinically-Significant Elevations of Alanine Aminotransferase/Serum Glutamate Pyruvate Transaminase (ALT/SGPT) During the 12-week Treatment Period and 4-week Follow-up Period|Clinically significant elevations of ALT/SGPT were considered ≥3 times the upper limit of normal (ULN). The percentage of participants above 2- and 5-fold ULN was not analyzed due to the early termination of the trial. The percentage of participants with ALT 3-fold ULN or higher is presented.|Baseline through 12 weeks, Baseline through 16 weeks|Only randomized participants with a baseline value and at least 1 post-baseline value of the response variable were included in the analysis.||percentage of participants|||Number
807533|NCT01024244|Secondary|Percentage of Participants With Lipase and Amylase Measurements Above 2-fold Upper Limits of Normal (ULN) During the 12-week Treatment Period|Lipase and amylase concentrations were assessed. Amylase normal limits for males and females are 28-100 units per liter (U/L) (18-50 years), 28-120 U/L (50-60 years), and 28-150 U/L (60-70 years). Normal lipase limits for males and females are 0-100 U/L (18-50 years; 50-60 years) and 0-120 U/L (60-70 years). Study GMAH was terminated after enrolling only 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline through 12 weeks|Data were reviewed but are not presented due to insufficient sample size.||percentage of participants|||Number
807535|NCT01024244|Secondary|Change From Baseline in the Seven-Point Self-Monitored Blood Glucose (7-point SMBG) at 4 Weeks, 12 Weeks, and 16 Weeks|SMBG levels were measured at the following 7 timepoints during the day: fasting pre-breakfast, 2 hours post-breakfast, prior to lunch, 2 hours post-lunch, prior to dinner, 2 hours postdinner, and prior to bed. Study GMAH was terminated after enrolling only 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline, 4 weeks, 12 weeks, 16 weeks|Data were reviewed but are not presented due to insufficient sample size.||millimoles per liter (mmol/L)||Standard Deviation|Mean
807536|NCT01024244|Secondary|Change From Baseline in Body Weight at 12 Weeks and 16 Weeks|Weight was measured in the fasting state (with the exception of Visit 1) and after emptying the bladder. Participants were instructed to be lightly clothed and without shoes. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline, 12 weeks, 16 weeks|Data were reviewed but are not presented due to insufficient sample size.||kilograms (kg)||Standard Deviation|Mean
807537|NCT01024244|Secondary|Number of Hypoglycemic Episodes During 12-Week Treatment Period and 4-week Follow-up Period|Hypoglycemia was defined as any time a participant feels s/he was experiencing a sign or symptom associated with hypoglycemia or had a blood glucose <70 mg/dL (3.9 mmol/L) even if it was not associated with signs or symptoms of hypoglycemia. Study GMAH was terminated after enrolling only 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline through 16 weeks|Data were reviewed but are not presented due to insufficient sample size.||hypoglycemic episodes|||Number
807538|NCT01024244|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at 12 Weeks and 16 Weeks|Change in SBP and DBP following 12 weeks of therapy (Week 12 SBP minus SBP at baseline; Week 12 DBP minus DBP at baseline) and 16 weeks of therapy (Week 16 SBPB minus SBP at baseline; Week 16 DBP minus DBP at baseline). Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline, 12 weeks, 16 weeks|Data were reviewed but are not presented due to insufficient sample size.||mm Hg||Standard Deviation|Mean
807539|NCT01024244|Secondary|Change From Baseline in the European Quality of Life -5 Dimension (EQ-5D) at 12 Weeks and 16 Weeks|Assesses 5 health domains: mobility, self-care, usual activity, pain, and anxiety/depression with 3 options each. Total scores range from 5 (no problem) to 15 (more severe or frequent problems). An algorithm maps the 5 domain outcomes to a single index (0-1). A higher score indicates better perceived health state. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline, 12 weeks, 16 weeks|Quality of life data were not analyzed due to insufficient sample size.||units on a scale||Standard Deviation|Mean
807540|NCT01024244|Secondary|Change From Baseline in Triglycerides, Low-density Lipoprotein Cholesterol (LDL-C), High-density Lipoprotein Cholesterol (HDL-C), Non-HDL-C, Total Cholesterol, and Free Fatty Acids at 12 Weeks and 16 Weeks|Fasting lipids were measured after an overnight fast. Lipids measured included triglycerides, HDL-C, LDL-C, non-HDL-C, total cholesterol, and free fatty acids. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline, 12 weeks, 16 weeks|Data were reviewed but not presented due to insufficient sample size.||millimoles per liter (mmoL/L)||Standard Deviation|Mean
807541|NCT01024244|Secondary|Change From Baseline in the Homeostasis Model Assessment (HOMA2) of Insulin Sensitivity (%S) at 12 Weeks and 16 Weeks|HOMA2 is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S), as percentages of a normal reference population (normal young adults). The normal reference population was set at 100%. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not calculated or analyzed.|Baseline, 12 weeks, 16 weeks|HOMA2 (%S) was not calculated due to insufficient sample size.||percentage of insulin sensitivity (%S)||Standard Deviation|Mean
807542|NCT01024244|Secondary|Change From Baseline in the Homeostasis Model Assessment (HOMA2) Pancreatic Beta Cell Function (%B) at 12 Weeks and 16 Weeks|HOMA2 is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state pancreatic beta cell function (%B) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not calculated or analyzed.|Baseline, 12 weeks, 16 weeks|HOMA2 (%B) was not calculated due to insufficient sample size.||percentage of beta cell function (%B)||Standard Deviation|Mean
807543|NCT01024244|Secondary|Change From Baseline in the QT Interval in Electrocardiogram (ECG) at 12 Weeks and 16 Weeks|Measures the QT interval in the ECG. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline, 12 weeks, 16 weeks|The QT interval was not analyzed due to insufficient sample size.||milliseconds (ms)||Standard Deviation|Mean
807544|NCT01024244|Primary|Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at 12 Weeks|Change in HbA1c from baseline following 12 weeks of therapy (HbA1c at week 12 minus HbA1c at baseline). Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline, 12 weeks|Data were reviewed but are not presented due to insufficient sample size.||percentage of glycosylated hemoglobin||Standard Deviation|Mean
807545|NCT01024309|Secondary|WOMAC|Total score from the Western Ontario and McMaster Universities Arthritis Index (WOMAC), which is a widely used set of standardized questionnaires used to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. WOMAC measures five items for pain (score range 0–20), two for stiffness (range 0–8), and 17 for functional limitation (range 0–68). Physical functioning questions cover everyday activities such as stair use, standing up from a sitting or lying position, standing, bending, walking, getting in/out of a car, shopping, putting on or taking off socks, lying in bed, getting in or out of a bath, sitting, and heavy and light household duties. It produces three subscale scores (pain, stiffness, and physical function) and a total score. These scores are transformed into a scale of 0 (worst possible outcome) to 100 (best possible outcome) for ease of interpretation and comparison with other studies.|12 month|A total of 37 participants returned for follow-up at 12 months. The remaining patients did not return to the clinic for follow-up at 12 months.||units on a scale||Inter-Quartile Range|Median
807546|NCT01024309|Secondary|Harris Hip Score|The postoperative rate of improvement in functional outcome, measured by the Harris Hip Score (HHS). The HHS was developed to assess the results of hip surgery and is intended to evaluate various hip disabilities and methods of treatment in an adult population. The domains covered are pain, function, absence of deformity, and range of motion. The function domain consists of daily activities (stair use, using public transportation, sitting, and managing shoes and socks) and gait (limp, support needed, and walking distance). Deformity takes into account hip flexion, adduction, internal rotation, and extremity length discrepancy. Range of motion measures hip flexion, abduction, external and internal rotation, and adduction. There are 10 items, which are summed to create a score out of 100. The score has a range of 0 (wost possible outcome) to 100 (best possible outcome) covering pain (0–44 points), function (0–47 points), absence of deformity (4 points), and range of motion (5 points).|12 month|A total of 37 participants returned for follow-up at 12 months. The remaining patients did not return to the clinic for follow-up at 12 months.||units on a scale||Inter-Quartile Range|Median
807547|NCT01024309|Secondary|WOMAC|Total score from the Western Ontario and McMaster Universities Arthritis Index (WOMAC), which is a widely used set of standardized questionnaires used to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. WOMAC measures five items for pain (score range 0–20), two for stiffness (range 0–8), and 17 for functional limitation (range 0–68). Physical functioning questions cover everyday activities such as stair use, standing up from a sitting or lying position, standing, bending, walking, getting in/out of a car, shopping, putting on or taking off socks, lying in bed, getting in or out of a bath, sitting, and heavy and light household duties. It produces three subscale scores (pain, stiffness, and physical function) and a total score. These scores are transformed into a scale of 0 (worst possible outcome) to 100 (best possible outcome) for ease of interpretation and comparison with other studies.|6 week|A total of 54 participants returned for follow-up at 6 weeks. 3 participants did not complete the WOMAC in its entirety at this appointment and, thus, were excluded from the analysis. The remaining patients did not return to the clinic for follow-up at 6 weeks.||units on a scale||Inter-Quartile Range|Median
807548|NCT01024309|Secondary|Harris Hip Score|The postoperative rate of improvement in functional outcome, measured by the Harris Hip Score (HHS). The HHS was developed to assess the results of hip surgery and is intended to evaluate various hip disabilities and methods of treatment in an adult population. The domains covered are pain, function, absence of deformity, and range of motion. The function domain consists of daily activities (stair use, using public transportation, sitting, and managing shoes and socks) and gait (limp, support needed, and walking distance). Deformity takes into account hip flexion, adduction, internal rotation, and extremity length discrepancy. Range of motion measures hip flexion, abduction, external and internal rotation, and adduction. There are 10 items, which are summed to create a score out of 100. The score has a range of 0 (wost possible outcome) to 100 (best possible outcome) covering pain (0–44 points), function (0–47 points), absence of deformity (4 points), and range of motion (5 points).|6 week|54 participants returned for follow-up at 6 weeks. A total of 5 participants did not complete the Harris Hip Score instrument in its entirety at this appointment and, thus, were excluded from the analysis. The remaining patients did not return to the clinic for follow-up at 6 weeks.||units on a scale||Inter-Quartile Range|Median
807549|NCT01024309|Secondary|Anteversion Angle|Anteversion angle is a radiographic measure of implant position. 35 degrees of anteversion is optimal. 25-45 degrees of anteversion indicates correct placement of prosthetic joint. Values closer to 35 degrees indicate better placement.|6 week|A total of 54 participants returned for follow-up at 6 weeks. The remaining patients did not return to the clinic for follow-up at 6 weeks.||degrees||Inter-Quartile Range|Median
807550|NCT01024309|Secondary|Abduction Angle|Abduction angle is a radiographic measure of implant position. 40 degrees of abduction is optimal. 30-50 degrees of anteversion indicates correct placement of prosthetic joint. Values closer to 40 degrees indicate better placement.|6 wk|A total of 54 participants returned for follow-up at 6 weeks. The remaining patients did not return to the clinic for follow-up at 6 weeks.||degrees||Inter-Quartile Range|Median
807551|NCT01024309|Secondary|Western Ontario and McMaster Universities Arthritis Index (WOMAC)|Total score from the Western Ontario and McMaster Universities Arthritis Index (WOMAC), which is a widely used set of standardized questionnaires used to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. WOMAC measures five items for pain (score range 0–20), two for stiffness (range 0–8), and 17 for functional limitation (range 0–68). Physical functioning questions cover everyday activities such as stair use, standing up from a sitting or lying position, standing, bending, walking, getting in/out of a car, shopping, putting on or taking off socks, lying in bed, getting in or out of a bath, sitting, and heavy and light household duties. It produces three subscale scores (pain, stiffness, and physical function) and a total score. These scores are transformed into a scale of 0 (worst possible outcome) to 100 (best possible outcome) for ease of interpretation and comparison with other studies.|3 week|A total of 53 participants returned for follow-up at 3 weeks. The remaining patients did not return to the clinic for follow-up at 3 weeks.||units on a scale||Inter-Quartile Range|Median
808057|NCT01019694|Secondary|Change From Baseline in FEV1 at Week 12|Change from test-day baseline in Forced Expiratory Volume in 1 second (FEV1) at 1 hour post dose at Week 12|baseline, 12 weeks|Treated Set is defined as all patients who were randomized and received study drug||liters||Standard Error|Least Squares Mean
807552|NCT01024309|Secondary|Harris Hip Score|The postoperative rate of improvement in functional outcome, measured by the Harris Hip Score (HHS). The HHS was developed to assess the results of hip surgery and is intended to evaluate various hip disabilities and methods of treatment in an adult population. The domains covered are pain, function, absence of deformity, and range of motion. The function domain consists of daily activities (stair use, using public transportation, sitting, and managing shoes and socks) and gait (limp, support needed, and walking distance). Deformity takes into account hip flexion, adduction, internal rotation, and extremity length discrepancy. Range of motion measures hip flexion, abduction, external and internal rotation, and adduction. There are 10 items, which are summed to create a score out of 100. The score has a range of 0 (wost possible outcome) to 100 (best possible outcome) covering pain (0–44 points), function (0–47 points), absence of deformity (4 points), and range of motion (5 points).|3 week|A total of 53 participants returned for follow-up at 3 weeks. The remaining patients did not return to the clinic for follow-up at 3 weeks.||units on a scale||Inter-Quartile Range|Median
807553|NCT01024309|Primary|Number of Days for Discontinue Assistive Devices|The primary early functional endpoint is the difference between groups in the postoperative days that patients require any assistive devices for ambulation. Lower number of days indicate better outcomes.|6 week|A total of 54 participants returned for follow-up at 6 weeks. The remaining patients did not return to the clinic for follow-up at 6 weeks.||days||Inter-Quartile Range|Median
807554|NCT01024335|Primary|Retention|Of those participants randomized to the naltrexone and dronabinol arm, the number that completed all 8 weeks of treatment.|retention over 8 weeks.|||participants|||Number
807555|NCT01024335|Primary|Opiate Withdrawal Measured by the Subjective Opiate Withdrawal Scale (SOWS) .|The Subjective Opiate Withdrawal Scale is a self-administered 16 scale containing 16 symptoms ranging in severity from 0 (not at all) to 4 (extremely). The SOWS total score is the sum of 16 items, ranging from 0 (no opiate withdrawal ) to 64 ( severe opiate withdrawal). Values from multiple assessments during the 8-week outpatient phase were averaged.|3x/week during 8 weeks of the trial or study participation|||units on a scale||Standard Deviation|Mean
807556|NCT01024465|Primary|Total Weight Loss|Mean weight loss in kilograms compared with the baseline value through 6 months of study follow up.|baseline to 180 days|Subjects with a weight recorded at 6 months||kg||Standard Deviation|Mean
807557|NCT01024608|Secondary|Change From Baseline in AM and PM Subject-reported Reflective Ocular Symptom Score Over the 2-week Treatment Period|"Participants recorded the severity of their ocular symptoms (Itching/burning eyes, tearing/watering eyes, and redness of eyes) over the past 12 hours (prior to the assessment) twice daily (AM and PM) using the following scale:
0=absent (no sign/symptom present); 1=mild (sign/symptom present, easily tolerated); 2=moderate (definite awareness of sign/symptom, bothersome but tolerable); 3=severe (sign/symptoms hard to tolerate, interfere with daily activities).
The total ocular symptom score ranges from 0 to 9 (worst symptoms). A negative change from baseline score indicates improvement."|Baseline (Days -3 to 0), and Days 1-15|Intent to treat population||units on a scale||Standard Error|Least Squares Mean
807558|NCT01024608|Secondary|Change From Baseline at Week 2 in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in Participants With Impaired Quality of Life at Baseline|The adult RQLQ has 28 questions in 7 domains. Participants were asked to recall their experiences during the previous week and to give their responses on a 7-point scale (0 = Not Troubled to 6 = Extremely Troubled) for the domains of activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, and eye symptoms. The domain of ‘emotional’ utilized a separate scale (0 = None of the time to 6 = All of the time). The overall RQLQ score is the mean of all 28 responses. Week 2 scores were compared to baseline scores. A negative change from baseline score indicates improvement.|Day 0 (Baseline), Day 15|The RQLQ population, subset of ITT population, included only those participants over the age of 18 years (fluent in English) with an impaired quality of life at Baseline as defined by a RQLQ score at Day 0 of 3.0 or greater.||units on a scale||Standard Error|Least Squares Mean
807559|NCT01024608|Secondary|Change From Baseline in Average Subject-Reported AM and PM Instantaneous Total Nasal Symptom Score (iTNSS) Over the Two-week Treatment Period|"Participants recorded the severity of their nasal symptoms (sneezing, runny nose, nasal itching and nasal congestion) over the past 10 minutes (prior to the assessment) twice daily (AM and PM) using the following scale:
0=absent (no sign/symptom present); 1=mild (sign/symptom present, easily tolerated); 2=moderate (definite awareness of sign/symptom, bothersome but tolerable); 3=severe (hard to tolerate, interfere with daily activities).
The iTNSS (sum of the 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from baseline score indicates symptom improvement."|Baseline (Days -3 to 0), and Days 1-15|Intent to treat population||units on a scale||Standard Error|Least Squares Mean
807560|NCT01024608|Primary|Change From Baseline in Average Subject-Reported AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Two-week Treatment Period|"Participants recorded the severity of their nasal symptoms (sneezing, runny nose, nasal itching and nasal congestion) over the past 12 hours (prior to the assessment) twice daily (AM and PM) using the following scale:
0=absent (no sign/symptom present); 1=mild (sign/symptom present, easily tolerated); 2=moderate (definite awareness of sign/symptom, bothersome but tolerable); 3=severe (hard to tolerate, interfere with daily activities and/or sleeping).
The rTNSS (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from baseline score indicates symptom improvement."|Baseline (Days -3 to 0), and Days 1-15|Intent to treat population||units on a scale||Standard Error|Least Squares Mean
807561|NCT01024738|Primary|Plaque Index|Plaque score is Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|4 Days|||Units on a scale||Standard Deviation|Mean
807562|NCT01024751|Secondary|Slit Lamp Findings|Graded slit lamp findings for each eye greater than grade 2 included epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, superior tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates. Slit lamp findings are grade on a scale of 0-4 with 0=none and 4=severe. Over All Follow-up Visits summarizes the worst case over all follow-up visits.|Over all visits for 1 month|Greater than grade 2 for all dispensed eyes with non-missing scores||eyes|Participants||Number
808058|NCT01019694|Secondary|Change From Baseline in FEV1 at Day 1|Change from test-day baseline in Forced Expiratory Volume in 1 second (FEV1) at 1 hour post dose on test day 1.|baseline, day 1|Treated Set is defined as all patients who were randomized and received study drug||liters||Standard Error|Least Squares Mean
807563|NCT01024751|Primary|Comfort-related Symptoms/Complaints|Participants rated their subjective symptoms/complaints using a 0 to 100 scale for each eye. A 0 represented the least favorable rating, and a 100 represented the most favorable rating. Over All Follow-Up Visits summarizes the average over all follow-up visit summaries.|At dispensing visit and each follow-up visit at week 2 and week 4.|Summaries included all eligible, dispensed participants, with participants summarized under the study products received.||Units on a scale|Participants|Standard Deviation|Mean
807564|NCT01024855|Primary|Number of Eyes With No Change in Corneal Staining|Subjects examined after corneal staining (a method used to assess the condition of the cornea) using a slit lamp to determine change from baseline and rated based on the following scale: 0=no change from baseline, 1=trace, 2=mild, 3=moderate, 4=severe.|Change from baseline after 1, 2, 4 and 6+ hours of wear|per protocol||eyes|||Number
807565|NCT01024946|Primary|To Determine the Rate of Clinical Benefit (i.e. Rate of Complete or Partial Response Plus Stable Disease) at 16 Weeks for Patients With Malignant Mesothelioma Treated With Everolimus as Second or Third Line Therapy.|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|16 weeks|||participants|||Number
807566|NCT01024959|Primary|Association of PCA3 Score With Prostate Biopsy Outcome (PCA3 Score Using Cutoff of 25.)|The likelihood of positive biopsy was determined by the PCA3 Score expressed as a binary categorical variable: PCA3 Score >=25 was positive, PCA3 Score <25 was negative|At the time of biopsy|A total of n=466 subjects have valid and reportable PCA3 Scores and disease status (determined by biopsy result), and who were 50 years of age or older.||participants|||Number
807567|NCT01024972|Secondary|In-hospital Mortality|Number of subjects who expired during hospitalization.|up to 90 days|||participants|||Number
807568|NCT01024972|Secondary|Liver Toxicity|Number of subjects who developed liver toxicity as evidenced by Liver Function Test elevation greater than 5 times the upper limit of normal.|7 days|||participants|||Number
807569|NCT01024972|Primary|Hyponatremia|Number of subjects who developed hyponatremia (sNa ≤132mmol/L)|Seven days|||participants|||Number
807570|NCT01009619|Secondary|Plasma C-reactive Protein (CRP) Levels|Plasma C-reactive protein (CRP) levels were assessed using Tina-quant CRP latex assay, Roche, Mannheim, Germany; sensitivity threshold of 1 mg/L, upper limit of normal 5 mg/L.|during the first two years post-transplant|||mg/L||Standard Deviation|Mean
807571|NCT01009619|Secondary|Broncho-alveolar (BAL) Neutrophilia|BAL was performed with two 50 mL aliquots of sterile saline at room temperature. Five mL of the recovered BAL fluid was sent for microbiological and virological assessment, whereas the remaining fluid was analysed for cell counts after a cytospin was made in a Shandon cytocentrifuge and stained with May-Grünwald-Giemsa. Differential cell counts were determined by counting at least 300 cells.|during first two years post-transplant|||percent cells||Standard Deviation|Mean
807572|NCT01009619|Secondary|Pulmonary Function|Spirometry (Masterscreen, Jaeger, Hoechberg, Germany) was performed at twice weekly intervals for the first 2 postoperative months, thereafter at weekly to biweekly intervals until 6 months post-transplantation, then every 2 to 4 weeks until the first postoperative year and afterwards life-long at intervals of 2 to 3 months according to American Thoracic Society standards and forced expiratory volume in one second (FEV1) expressed in terms of the percentage of predicted values.|during first two years post-transplant|||percent predicted||Standard Deviation|Mean
807573|NCT01009619|Secondary|Infection Incidence Rate|Cytomegalovirus (CMV)-status was assessed on on every broncho-alevolar lavage sample and by serum CMV DNA at weekly intervals during hospitalization and thereafter at each outpatient evaluation or hospital admission. Immunohistochemical staining for CMV was performed on transbronchial biopsies in case of clinical suspicion of infection (i.e. dyspnea, cough, sputum, fever, increased plasma C-reactive protein, new chest radiograph infiltrates, or a decrease of at least 10% in peak expiratory flow (PEF) as measured by patient’s peak flow measurements.|2 years post-transplant|intention to treat||incidence rate (events/person per year)||Standard Deviation|Mean
807574|NCT01009619|Secondary|Acute Rejection Incidence Rate|Bronchoscopy and broncho-alveolar lavage (BAL) was routinely performed at discharge, 3, 6, 12, 18, 24 months post-transplantation and later at intervals of 1 year, or in case of clinically suspected acute allograft rejection, infection or chronic rejection. Transbronchial biopsies were routinely performed at discharge and 3 months post-transplant or in case of suspected acute rejection, infection or chronic rejection. Biopsies were graded according to the 1996 ISHLT-guidelines (grade A0-4 with concomitant B0-4), as well as assessed for other interstitial lesions of the pulmonary graft.|2 years post-transplant|||incidence rate (events/person per year)||Standard Deviation|Mean
807575|NCT01009619|Primary|Overall Survival|Survival data were obtained using all-cause mortality information in the Leuven University Hospital transplant database, in which all our lung transplant recipients since 1991 are registered. For the end-point of all-cause mortality, survival times were not censored at retransplantation or at study-discontinuation if these preceded death, or else at 2 years after transplantation.|2 years post-transplant|intention to treat||participants|||Number
807576|NCT01009619|Primary|Prevalence of Bronchiolitis Obliterans Syndrome (BOS)|BOS was defined as a sustained decrease in forced Expiratory Volume in one second (FEV1) of at least 20% from the patient's maximum post-operative values in the absence of other causes.|2 years post-transplant|intention to treat analysis||participants|||Number
807577|NCT01009645|Secondary|Recall Accuracy|"Participants were given 8 statements about the flu/flu shot and asked to recall if they had seen the statement on the message they received via FedEx. Participants responded that statement had been presented as a fact, presented as a myth, presented, but I don't recall if it was a fact or a myth, or not presented. Participants scored 1 for each correct answer; 0 for each incorrect answer or for response I don't recall. Recall accuracy was calculated among each message format, range for recall accuracy was 0 - 8 with 0 indicating no correct answers and 8 representing 100% accuracy. Thus units of measurement are units on a scale to represent participant scores out of 8 on the recall items."|1 week following receipt of message|||units on a scale||Standard Deviation|Mean
807578|NCT01009645|Primary|Influenza Vaccination|The primary outcome is receipt of influenza vaccination at appointment directly following the post-test. A pre-test was completed by participants during a telephone interview that occurred approximately two weeks prior to a scheduled clinic appointment. The post-test was completed via an in-person interview by participants immediately prior to their scheduled appointment. That is, the participants met with the Research Assistant, completed the post-test, and then proceeded to see their physician for a previously scheduled office visit.|1 week following randomization|||participants|||Number
807579|NCT01014975|Primary|Incidence of Symptomatic Intracranial Hemorrhage (SICH) by Dose Cohort||90 days|Safety Population||participants|||Number
807580|NCT01014988|Secondary|Geometric Mean Volume of Distribution (Vd) of Zanamivir|"The Vd of zanamivir was evaluated. Volume of distribution is defined as the apparent volume in which zanamivir is distributed. Serial blood samples for PK analysis were collected if possible in conjunction with the initial dose on Day 1 (5-7 serial samples) and over a dosing interval during repeat dosing on Days 3, 4, or 5 (5 serial samples). PK data for all participants with available blood samples were analyzed. PK data for those participants with a CLcr >= 80 mL/minutes (>=80 mL/minute/1.73m^2 for cohorts 1-4) and who received an ID and a MD of 14 mg/kg (6 months to <6 years of age), 12 mg/kg, not to exceed 600 mg (6 to <18 years of age) or 600 mg zanamivir (>=18 years of age) (represented by n=X in the category titles) were summarized. NA indicates that data are not available/analysis was not performed."|Day 1 and Days 3, 4, or 5|PK Parameter Population||Liters (L)||Geometric Coefficient of Variation|Geometric Mean
807581|NCT01014988|Secondary|Geometric Mean Serum Clearance of Zanamivir|"The serum clearance of zanamivir was evaluated. Clearance is defined as the volume of zanamivir per unit time eliminated from serum. Serial blood samples for PK analysis were collected if possible in conjunction with the initial dose on Day 1 (5-7 serial samples) and over a dosing interval during repeat dosing on Days 3, 4, or 5 (5 serial samples). PK data for all participants with available blood samples were analyzed. PK data for those participants with a CLcr >=80 mL/minutes (>=80 mL/minute/1.73m^2 for cohorts 1-4) and who received an ID and a MD 14 mg/kg (6 months to <6 years of age), 12 mg/kg, not to exceed 600 mg (6 to <18 years of age) or 600 mg zanamivir (>=18 years of age) (represented by n=X in the category titles) were summarized. NA indicates that data are not available/analysis was not performed."|Day 1 and Days 3, 4, or 5|PK Parameter Population||mL per minutes||Geometric Coefficient of Variation|Geometric Mean
807582|NCT01014988|Secondary|Geometric Mean Terminal Half Life (t1/2) of Zanamivir|"The t1/2 of zanamivir was evaluated. Terminal half life is defined as the time it takes for a substance to lose half of its pharmacologic, physiologic, or radiologic activity. Serial blood samples for PK analysis were collected if possible in conjunction with the initial dose on Day 1 (5-7 serial samples) and over a dosing interval during repeat dosing on Day 3, 4, or 5 (5 serial samples). PK data for all participants with available blood samples were analyzed. PK data for those participants with a CLcr>=80 mL/minutes (>=80 mL/minute/1.73m^2 for cohorts 1-4) and who received an ID and a MD of 14 mg/kg (6 months to <6 years of age), 12 mg/kg, not to exceed 600 mg (6 to <18 years of age) or 600 mg zanamivir (>=18 years of age) (represented by n=X in the category titles) were summarized. NA indicates that data are not available/analysis was not performed."|Day 1 and Days 3, 4, or 5|PK Parameter Population||Hours||Geometric Coefficient of Variation|Geometric Mean
807583|NCT01014988|Secondary|Geometric Mean Area Under the Serum Drug Concentration-time Curve (AUC) Over a 12-hour Dosing Interval (AUC[0-tau]) and AUC Extrapolated to Infinity (AUC[0-inf]) of Zanamivir|"The AUC(0-tau) during the repeat dose interval and AUC(0-inf) for the initial dose were evaluated. Serial blood samples for PK analysis were collected if possible in conjunction with the initial dose on Day 1 (5-7 serial samples) and over a dosing interval during repeat dosing on Days 3, 4, or 5 (5 serial samples). PK data for all participants with available blood samples were analyzed. PK data for those participants with a CLcr >=80 mL/minutes (>=80 mL/minute/1.73m^2 for cohorts 1-4) and who received an ID and a MD of 14 mg/kg (6 months to <6 years of age), 12 mg/kg, not to exceed 600 mg (6 to <18 years of age) or 600 mg zanamivir (>=18 years of age) (represented by n=X in the category titles) were summarized. NA indicates that data are not available/analysis was not performed."|Day 1 and Days 3, 4, or 5|PK Parameter Population||Micrograms*hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
807584|NCT01014988|Secondary|Geometric Mean Maximum Serum Concentration (Cmax) of Zanamivir at the End of Infusion|"The Cmax of zanamivir was evaluated at the end of infusion. Serial blood samples for pharmacokinetic (PK) analysis were collected if possible in conjunction with the initial dose on Day 1 (5-7 serial samples) and over a dosing interval during repeat dosing on Days 3, 4, or 5 (5 serial samples). PK data for all participants with available blood samples were analyzed. PK data for those participants who were neither on extracorporeal membrane oxygenation (ECMO) nor on continuous renal replacement therapy (CRRT), who were with CLcr >=80 mL/minutes (>=80mL/minute/1.73m^2 for cohorts 1-4) and who received an initial dose (ID) and a maintenance dose (MD) of 14 mg/kg (6 months to <6 years of age), 12 mg/kg, not to exceed 600 mg (6 to <18 years of age) or 600 mg zanamivir (>=18 years of age) (represented by n=X in the category titles) were summarized. NA indicates that data are not available/analysis was not performed."|Day 1 and Days 3, 4, or 5|PK Parameter Population: participants with one or more estimated zanamivir PK parameters||Micrograms per mL||Geometric Coefficient of Variation|Geometric Mean
807585|NCT01014988|Secondary|Median Duration of Hospitalization and Intensive Care Unit (ICU) Stays|The duration of hospitalization (H) reflects the number of hospitalization days between the date of the first dose of investigational product and the date of discharge. ICU stay includes total duration in ICU and may include days in ICU before entry into the study. For participants with a missing discharge date who were not discharged at the end of the study, the date of discharge was imputed to the last follow-up visit (post-treatment +23 days). Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Up to discharge from hospital|ITT-E Population||Days||Full Range|Median
807586|NCT01014988|Secondary|Number of Participants Who Used Any Concomitant Antibiotic Medications for Complications of Influenza|Concomitant medications (prescription and non-prescription) were permitted during the course of the study at the Investigator’s discretion (except for prohibited medications: during the treatment period with IV zanamivir, other influenza antiviral drugs were not permitted). The number of participants who were treated with antibiotics for influenza complications was summarized.|Up to post-treatment (PT) + 23 days|ITT-E Population||Participants|||Number
817591|NCT01112579|Secondary|Characterize the Change in proBNP Between the Treatment Arm and Control Arm Through 6 Months||Baseline and 6 Months|||pg/mL||Standard Deviation|Mean
807587|NCT01014988|Secondary|Number of Participants With Any AE Categorized as an Influenza Complication|An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.|Up to post-treatment (PT) + 23 days|ITT-E Population||Participants|||Number
807588|NCT01014988|Secondary|Median Time to Clinical Response (Sustained Resolution) of All Vital Signs (Composite)|Sustained resolution of the following vital signs (composite) was assessed: afebrile status, normal oxygen saturation, normal respiratory status, normal HR, and normal BP. Clinical response is defined as the resolution of at least four of five vital signs within the following resolution criteria, maintained for 24 hours or hospital discharge, whichever occurred first: Temperature in degrees Centigrade (<=36.6 axilla, <=37.2 oral, <=37.7 rectal, core or tympanic); oxygen saturation (>=95%, without supplemental oxygen); respiratory status (return to pre-morbid oxygen requirement, or no need for supplemental oxygen, or respiratory rate <=60, <=40, <=34, <=30, <=24 or <=24 breaths/minute without supplemental oxygen for Cohorts 1-6 respectively); HR (<=160, <=150, <=140, <=120, <=100 or <=100 bpm for Cohorts 1-6 respectively); SBP (>=70, >=74, >=76, >=80, >=90 or >=90 mmHg for Cohorts 1-6 respectively). Only those participants available at the specified time points were analyzed.|Up to post-treatment (PT) + 23 days|ITT-E Population||Days||Full Range|Median
807589|NCT01014988|Secondary|Number of Participants With the Indicated Mortality Status at Day 14 and Day 28|The number of participants who died on or before Study Day 14 and Study Day 28 was summarized. Only those participants available at the specified time points were analyzed.|Day 14 and Day 28|ITT-E Population||Participants|||Number
807590|NCT01014988|Secondary|Median Time to Return to Pre-morbid Functional Status|Time to return to pre-morbid functional status was assessed on a 3-point scale (bed rest, limited ambulation, or unrestricted). Only those participants available at the specified time points were analyzed.|Up to post-treatment (PT) + 23 days|ITT-E Population||Days||Full Range|Median
807591|NCT01014988|Secondary|Duration of Mechanical Ventilation and Supplemental Oxygen Use|Due to the conditional nature of data collection post treatment, the duration of mechanical ventilation and supplemental oxygen use were not determined.|Up to discharge from the hospital|ITT-E Population|||||
807592|NCT01014988|Secondary|Number of Participants With the Indicated Ventilation Status: Modality of Supplemental Oxygen Delivery and Mechanical Ventilation|Ventilation status was measured at Baseline (Day 1); Days 2, 3, 4, 5, 6, 7, 8, 9, and 10; and post-treatment +2 days, +5 days, +9 days, +16 days (assessments to be done if participant remained hospitalized), and +23 days. Ventilation status was assessed once daily during inpatient follow-up visits. The number of participants reported for machine-assisted: extracorporeal membrane oxygenation (ECMO), endotracheal mechanical ventilation, and supplemental oxygen delivery (SOD) at “any time (AT) on study” and at Baseline (Day 1) are summarized.|Up to post-treatment (PT) + 23 days|ITT-E Population||Participants|||Number
807593|NCT01014988|Secondary|Median Time to Resolution of Individual Vital Signs|Times to return to afebrile status (normal body temperature), normal respiratory status, normal heart rate, and normal systolic blood pressure were assessed. Afebrile status is defined as a temperature <=36.6 axilla, <=37.2 oral, or <=37.7 rectal, core or typanic, degrees Centigrade. A return to normal respiratory status is defined as either: (a) return to pre-morbid oxygen requirement; or (b) return to no need for supplemental oxygen; or (c) respiratory rate <=60, <=40, <=34, <=30, <=24 or <=24 breaths/minute (without supplemental oxygen) for Cohorts 1-6 respectively . A normal HR is defined as <=160, <=150, <=140, <=120, <=100 or <=100 bpm for Cohorts 1-6 respectively, and a normal SBP is defined as >=70, >=74, >=76, >=80, >=90 or >=90 mmHg for Cohorts 1-6 respectively. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X in the category titles).|Up to post-treatment (PT) + 23 days|ITT-E Population||Days||Full Range|Median
807594|NCT01014988|Secondary|Number of Participants With Treatment-emergent (TE) Mutations|Viral RNA isolated from participants at Baseline (Day 1) and post-Baseline visits were sequenced to determine the presence of TE neuraminidase (NA) and hemagglutinin (HA) mutations resulting from selective pressure. A mutation was considered to be TE if it was not present at Baseline and was present in the last post-Baseline sample analyzed.These mutations were classified as either known to confer zanamvir resistance or novel mutations with unknown clinical significance. Please note: pediatric data are pending and will be updated when available.|Baseline and up to post-treatment (PT) + 23 days|ITT-E Population||Participants|||Number
807595|NCT01014988|Secondary|Mean Viral Susceptibility to Zanamivir at Baseline (Day 1) and All Post-Baseline Visits Collectively|"Viral susceptibility to zanamivir at Baseline and at all post-Baseline visits collectively was assessed by neuraminidase (NA) enzyme inhibition assay. The mean IC50 data are summarized by subtype (A/H1N1, A/H3N2, B) and by visit. IC50 is defined as the concentration of zanamvir required to inhibit NA activity by 50%. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). NA indicates that data are not available/analysis was not performed. Please note: pediatric data are pending and will be updated when available."|Baseline and up to post-treatment (PT) + 23 days|ITT-E Population||Nanomolar (nM)||Standard Deviation|Mean
807596|NCT01014988|Secondary|Median Change From Baseline (Influenza A or B Quantitative PCR, as Appropriate) in Viral Load at the Indicated Time Points|"Change from Baseline in viral load was measured from nasopharyngeal swab samples, as determined by RT-PCR (PCR positive at Baseline). Nasopharyngeal swab samples were collected at Baseline (Day 1); Day 2, Day 3, Day 4, Day 5, Day 7, and Day 10; and, only if the participants had continued symptoms and were hospitalized, post-treatment (PT) samples were collected at +2 days, +5 days, +9 days, +16 days, and +23 days. 'PT +23 days' also comprises viral load values at early study withdrawal. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X in the category titles). NA indicates that data are not available/analysis was not performed."|Baseline (Day 1); Days 2, 3, 4, 5, 7, and 10; and post-treatment +2, +5, +9, +16, +23 days|ITT-E Population||Log10 copies per milliliter||Full Range|Median
807597|NCT01014988|Secondary|Median Time to Virologic Improvement|Time to virologic improvement is defined as a 2-log drop in viral load or undetectable viral ribonucleic acid (RNA) as measured by quantitative reverse transcriptase-polymerase chain reaction (RT-PCR) from nasopharyngeal samples (PCR positive at Baseline). Only those participants available at the specified time points were analyzed.|Up to post-treatment (PT) + 23 days|ITT-E Population consisted of all participants who receiveed at least one dose of IV zanamivir.||Days||Full Range|Median
807598|NCT01014988|Primary|Median Corrected QT Interval (QTc) for Heart Rate by Fridericia’s Formula (QTcF) and Bazett’s Formula (QTcB) at Baseline (Day 1) and Day 5|"Twelve-lead ECGs were recorded for the parameters of QTcF and QTcB. The first set of pre-dose ECG values at Baseline (Day 1) and the pre-dose ECG values at Day 5 are presented. Baseline is defined as the last pre-treatment value collected. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X, X in the category titles). NA indicates that data are not available/analysis was not performed. Cohort 1 QTcF and QTcB minimum values of 0.0 were data entry errors that could not be addressed after Data Base Freeze."|Baseline (Day 1) and Day 5|Safety Population||Milliseconds||Full Range|Median
807599|NCT01014988|Primary|Number of Participants Assessed as Normal/Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at Baseline (Day 1)|The number of participants with an ECG status of normal and abnormal CS or NCS, as determined by the Investigator, is reported. Normal=all ECG parameters within the accepted normal ranges. Abnormal=ECG findings outside of normal ranges. CS=ECG with a CS abnormality that meets exclusion criteria. NCS=ECG with an abnormality that is not CS nor meets exclusion criteria, per Investigator, based on reasonable standards of clinical judgment. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X in the category titles).|Baseline (Day 1)|Safety Population||Participants|||Number
807600|NCT01014988|Primary|Median Body Temperature at Baseline (Day 1) and Day 5|Body temperature was recorded at Baseline (Day 1), Days 2, 3, 4, 5, 6, 7, 8, 9, and 10; and post-treatment +2 days, +5 days, +9 days, +16 days (assessments to be done if participant remained hospitalized), and +23 days. Body temperature was recorded once daily during inpatient or outpatient follow-up visits. Median body temperature at Baseline (Day 1) and Day 5 is summarized. Baseline is defined as the last pre-treatment value collected. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X, X in the category titles).|Baseline (Day 1) and Day 5|Safety Population||Degrees centigrade||Full Range|Median
807601|NCT01014988|Primary|Median Respiration Rate at Baseline (Day 1) and Day 5|Respiration rate was measured at Baseline (Day 1), Days 2, 3, 4, 5, 6, 7, 8, 9, and 10; and post-treatment +2 days, +5 days, +9 days, +16 days (assessments to be done if participant remained hospitalized), and +23 days. Respiration rate was assessed once daily during inpatient or outpatient follow-up visits. The median respiration rate at Baseline (Day 1) and Day 5 is summarized. Baseline is defined as the last pre-treatment value collected. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X, X in the category titles).|Baseline (Day 1) and Day 5|Safety Population||Breaths per minute||Full Range|Median
807602|NCT01014988|Primary|Median Oxygen Saturation Measured Via Transcutaneous Oximetry (TCPO2) at Baseline (Day 1) and Day 5|TCPO2 is a noninvasive test that directly measures the oxygen level of tissue beneath the skin. Because oxygen is carried to tissues by blood flow in the arteries, TCPO2 is an indirect measure of blood flow. The percent (%) oxygen saturation was measured at Baseline (Day 1), Days 2, 3, 4, 5, 6, 7, 8, 9, and 10; and post-treatment +2 days, +5 days, +9 days, +16 days (assessments to be done if participant remained hospitalized), and +23 days. Oxygen saturation was assessed once daily during inpatient follow-up visits. The median oxygen saturation values at Baseline (Day 1) and Day 5 are summarized. Baseline is defined as the last pre-treatment value collected. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X, X in the category titles).|Baseline (Day 1) and Day 5|Safety Population||Percentage of oxygen level in blood||Full Range|Median
807603|NCT01014988|Primary|Median Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Baseline (Day 1) and Day 5|SBP and DBP were measured at Baseline (Day 1), Days 2, 3, 4, 5, 6, 7, 8, 9, and 10; post-treatment +2 days, +5 days, +9 days, +16 days (assessments to be done if participant remained hospitalized), and +23 days. SBP and DBP were assessed once daily during inpatient or outpatient follow-up visits. SBP and DBP values at Baseline (Day 1) and Day 5 are summarized. Baseline is defined as the last pre-treatment value collected. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X, X in the category titles).|Baseline (Day 1) and Day 5|Safety Population||Millimeters of mercury (mmHg)||Full Range|Median
807604|NCT01014988|Primary|Median Heart Rate at Baseline (Day 1) and Day 5|Heart rate was measured at Baseline (Day 1); Days 2, 3, 4, 5, 6, 7, 8, 9, and 10; post-treatment +2 days, +5 days, +9 days, +16 days (assessments to be done if participant remained hospitalized), and +23 days. Heart rate was assessed once daily during inpatient or outpatient follow-up visits. Heart rate values at Baseline (Day 1) and Day 5 are summarized. Baseline is defined as the last pre-treatment value collected. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X, X in the category titles).|Baseline (Day 1) and Day 5|Safety Population||Beats per minute (bpm)||Full Range|Median
807605|NCT01014988|Primary|Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Hematology Toxicities|A toxicity was considered to be TE if it was greater than the Baseline grade, and if it had developed or increased post-Baseline in intensity (and prior to the last dose of investigational product). The hematology parameters included hemoglobin, TN, and WBC count. Per the DAIDS table for grading the severity of adult and pediatric AEs, Grade 3=severe and Grade 4=potentially life threatening. Baseline is defined as the last pre-treatment value collected. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to post-treatment (PT) + 23 days|Safety Population||Participants|||Number
807606|NCT01014988|Primary|Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Clinical Chemistry Toxicities|A toxicity was considered to be TE if it was greater than the Baseline grade, and if it had developed or increased post-Baseline in intensity (and prior to the last dose of investigational product). Clinical chemistry parameters included ALT, TB, and creatinine. Per the DAIDS table for grading the severity of adult and pediatric AEs, Grade 3=severe and Grade 4=potentially life threatening. Baseline is defined as the last pre-treatment value collected. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to post-treatment (PT) + 23 days|Safety Population||Participants|||Number
807607|NCT01014988|Primary|Number of Participants With the Indicated Hematology Values Relative to the Normal Range at Baseline (Day 1) and Day 5|Blood samples for laboratory assessments were collected at Baseline (Day [D] 1), Days 3 and 5, and on post-treatment +2 days (if hospitalized) and post-treatment +23 days. Hematology parameters included hemoglobin, total neutrophils (TN), and white blood cell (WBC) count. The number of participants with values that were high (H)/normal (N)/low (L) relative to the normal range at Baseline (D 1) and D 5 for the indicated hematology parameters are summarized. Baseline is defined as the last pre-treatment value collected. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline (Day 1) and Day 5|Safety Population||Participants|||Number
807608|NCT01014988|Primary|Number of Participants With the Indicated Clinical Chemistry Values Relative to the Normal Range at Baseline (Day 1) and Day 5|Blood samples for laboratory assessments were collected at Baseline (Day [D] 1), Days 3 and 5, and on post-treatment +2 days (if hospitalized) and post-treatment +23 days. Clinical chemistry parameters included alanine aminotransferase (ALT), direct bilirubin (DB), total bilirubin (TB), and creatinine. The number of participants with values that were high (H)/normal (N)/low (L) relative to the normal range at Baseline (D 1) and D 5 for the indicated clinical chemistry parameters are summarized. Baseline is defined as the last pre-treatment value collected. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline (Day 1) and Day 5|Safety Population||Participants|||Number
807609|NCT01014988|Primary|Number of Participants Who Were Permanently Discontinued From the Study Due to an AE|An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.|Up to post-treatment (PT) + 23 days|Safety Population.||Participants|||Number
807610|NCT01014988|Primary|Number of Participants Who Permanently Discontinued the Study Treatment Due to an AE|An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.|Up to 10 days|Safety Population.||Participants|||Number
807611|NCT01014988|Primary|Number of Participants With Any Severe or Grade 3/4 Treatment-related AE|An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. AEs that occured during the study were evaluated by the Investigator and graded according to the DAIDS table for grading the severity of adult and pediatric AEs. Grade 3=severe; Grade 4=potentially life threatening. All AEs were assesed by the Investigateor as related or not related to the study treatment.|Up to post-treatment (PT) + 23 days|Safety Population.||Participants|||Number
807612|NCT01014988|Primary|Number of Participants With Any Severe or Grade 3/4 AEs|An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. AEs that occured during the study were evaluated by the Investigator and graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) table for grading the severity of adult and pediatric AEs. Grade 3=severe; Grade 4=potentially life threatening.|Up to post-treatment (PT) + 23 days|Safety Population.||Participants|||Number
807613|NCT01014988|Primary|Number of Participants With Any Adverse Event (AE) Considered to be Related to Study Treatment|An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. All AEs were assesed by the Investigateor as related or not related to the study treatment.|Up to post-treatment (PT) + 23 days|Safety Population: participants who received >=1 dose of study medication.||Participants|||Number
807621|NCT01015131|Secondary|Spearman's Rank Correlation Coefficient Between Change From Baseline in SUVmean After the First Cycle of SOC Neo-adjuvant Chemotherapy, and Change From Baseline in Tumor Volume at the End of SOC Neo-adjuvant Chemotherapy.|The Spearman's rank correlation coefficient was computed by ranking the data and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|Baseline and up to 30 weeks|Participants who had their SUVmean measured after 1 cycle of chemotherapy and their tumors measured at the end of chemotherapy||Correlation coefficient||90% Confidence Interval|Number
807622|NCT01015131|Secondary|Spearman's Rank Correlation Coefficient Between Change From Baseline in SUVmax After the First Cycle of SOC Neo-adjuvant Chemotherapy, and Change From Baseline in Tumor Volume at the End of SOC Neo-adjuvant Chemotherapy.|The Spearman's rank correlation coefficient was computed by ranking the data and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|Baseline and up to 30 weeks|Participants who had their SUVmax measured after 1 cycle of chemotherapy and their tumors measured at the end of chemotherapy||Correlation coefficient||90% Confidence Interval|Number
807623|NCT01015131|Primary|Spearman's Rank Correlation Coefficient Between Change From Baseline in Ki-67 Labeling Index and Change From Baseline in SUVmax After the First Cycle of SOC Neo-adjuvant Chemotherapy.|The Spearman's rank correlation coefficient was computed by ranking the data and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|Baseline and up to 3 weeks|Participants who had both their changes from baseline in Ki-67 LI and SUVmax determined at the end of Cycle 1 of chemotherapy.||Correlation coefficient||90% Confidence Interval|Number
807624|NCT01015131|Primary|Spearman's Rank Correlation Coefficient Between Change From Baseline in Ki-67 Labeling Index and Change From Baseline in SUVmean After the First Cycle of SOC Neo-adjuvant Chemotherapy.|The Spearman's rank correlation coefficient was computed by ranking the data and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|Baseline and up to 3 weeks|Participants who had both their changes from baseline in Ki-67 LI and SUVmean determined at the end of Cycle 1 of chemotherapy.||Correlation coefficient||90% Confidence Interval|Number
807625|NCT01015131|Primary|Change From Baseline in Ki-67 Labeling Index After the First Cycle of SOC Neo-adjuvant Chemotherapy.|Core needle biopsies (CNB) are obtained after completing imaging studies at baseline and approximately 2 to 3 weeks later, after the first cycle of chemotherapy. These tissue samples are then used to measure expression of the cell proliferation marker Ki-67, by manually counting percentage positive immunostained cells, denoted the labeling index (LI).|Baseline and up to 3 weeks|Participants whose Ki-67 Labeling Index were measured at Baseline and after 1 cycle of chemotherapy||Labeling Index||Standard Deviation|Mean
807626|NCT01015131|Primary|Change From Baseline in 18F-FLT-PET Maximum Standardized Uptake Value (SUVmax) After the First Cycle of SOC Neo-adjuvant Chemotherapy.|Participants undergo a baseline 18F-FLT-PET/CT scan followed by a magnetic resonance imaging (MRI) scan prior to chemotherapy. These scans are repeated in approximately 2 to 3 weeks, at the end of the first cycle of chemotherapy to derive a standardized uptake value (SUV) of 18F-FLT, which is calculated from the ratio of tissue radioactivity concentration within a region of interest, and the injected dose at the time of injection, divided by body weight. The SUVmax measures the maximum radioactivity values within a region of interest.|Baseline and up to 3 weeks|Participants whose SUV were measured at Baseline and after 1 cycle of chemotherapy||SUV||Standard Deviation|Mean
807627|NCT01015131|Secondary|Spearman's Rank Correlation Coefficient Between Change From Baseline in Ki-67 LI After the First Cycle of SOC Neo-adjuvant Chemotherapy, and Change From Baseline in Tumor Volume at the End of SOC Neo-adjuvant Chemotherapy.|The Spearman's rank correlation coefficient was computed by ranking the data and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|Baseline and up to 30 weeks|Participants who had their Ki-67 LI measured after 1 cycle of chemotherapy and their tumors measured at the end of chemotherapy||Correlation coefficient||90% Confidence Interval|Number
807628|NCT01015131|Secondary|Spearman's Rank Correlation Coefficient Between Change From Baseline in PSS After the First Cycle of SOC Neo-adjuvant Chemotherapy, and Change From Baseline in Tumor Volume at the End of SOC Neo-adjuvant Chemotherapy.|The Spearman's rank correlation coefficient was computed by ranking the data and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|Baseline and up to 30 weeks|Participants who had their PSS measured after 1 cycle of chemotherapy and their tumors measured at the end of chemotherapy||Correlation coefficient||90% Confidence Interval|Number
807629|NCT01015131|Secondary|Change From Baseline in Tumor Volume at the End of SOC Neo-adjuvant Chemotherapy.|MRI of participants was used to measure tumor volumes at baseline and after completing chemotherapy, after approximately 11 to 30 weeks of treatment.|Baseline and up to 30 weeks|Participants who had tumors measured by MRI at Baseline and at the end of chemotherapy||cm^3||Standard Deviation|Mean
807642|NCT01015287|Secondary|Percentage of Participants With Incidence of Cardiovascular (CV) Death or Myocardial Infarction (MI) Through 30 Days From First Loading Dose (LD)|The percentage of participants is the total number of participants experiencing a CV death or MI divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.|First LD through 30 days after first LD|All randomized participants who received at least 1 dose of study drug.||percentage of participants|||Number
807630|NCT01015131|Secondary|Change From Baseline in Proliferation Signature Score (PSS) After the First Cycle of SOC Neo-adjuvant Chemotherapy.|Core needle biopsies (CNBs) obtained at baseline and after approximately 2-3 weeks of treatment, at the end of the first cycle of chemotherapy, are used to measure cell proliferation by a Proliferation Signature Score (PSS). PSS is calculated from the messenger RNA (mRNA) expression of 47 genes that negatively correlate with time to recurrence, and involves taking their average normalized scores. For reference, a database of 16,000 tumors gave a minimum PSS of 1.51 and a maximum PSS of 2.89; where a higher PSS is associated with an increase in proliferation, higher tumor grade and worse outcomes.|Baseline and up to 3 weeks|Participants who had PSS determined at Baseline and after 1 cycle of chemotherapy||Proliferation Score||Standard Deviation|Mean
807631|NCT01015131|Primary|Change From Baseline in 18F-FLT-PET Mean Standardized Uptake Value (SUVmean) After the First Cycle of Standard of Care (SOC) Neo-adjuvant Chemotherapy.|Participants undergo a baseline 18F-FLT-PET/CT scan followed by a magnetic resonance imaging (MRI) scan prior to chemotherapy. These scans are repeated in approximately 2 to 3 weeks, at the end of the first cycle of chemotherapy to derive a standardized uptake value (SUV) of 18F-FLT, which is calculated from the ratio of radioactivity concentration within a region of interest, and the injected dose at the time of injection, divided by body weight. The SUVmean averages the radioactivity values within a region of interest.|Baseline and up to 3 weeks|Participants whose SUV were measured at Baseline and after 1 cycle of chemotherapy||SUV||Standard Deviation|Mean
807632|NCT01015170|Secondary|7-day Point Prevalence of Smoking Abstinence|"Number of participants who report Not Smoking (not even a puff) in past 7 days when asked 6 months after Zyban start date"|6 months after Zyban start date|Number of participants who completed 6 month post treatment survey||Participants|||Count of Participants
807633|NCT01015170|Secondary|Serious Quit Attempt (at Least 24 Hours of Abstinence)|Number of participants who report a serious quit attempt at End of treatment|End of Treatment (8 weeks after Zyban start date)|This secondary outcome was not collected at 8 week followup.|||||
807634|NCT01015170|Primary|7-day Point Prevalence of Smoking Abstinence|"Number of participants who report Not Smoking (not even a puff) in past 7 days when asked at week 8"|End of Treatment (8 weeks after Zyban start date)|Participants who completed survey 8 weeks after Zyban start date||participants|||Number
807635|NCT01015287|Other Pre-specified|Summary of All-Cause Death|All deaths, regardless of possible relatedness, were adjudicated by the Clinical Endpoint Committee (CEC) and are reported in this table.|Randomization through 30 days|All randomized participants who received at least 1 dose of study drug.||participants|||Number
807636|NCT01015287|Secondary|Percentage of Participants With Incidence of All Coronary Artery Bypass Graft (CABG) or Non-CABG Thrombolysis In Myocardial Infarction (TIMI) Major Bleeding|The percentage of participants is the total number of participants experiencing a CABG or non-CABG TIMI major bleeding divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.|First loading dose (LD) through 7 days after first LD|All randomized participants who received at least 1 dose of study drug.||percentage of participants|||Number
807637|NCT01015287|Secondary|Change in Standardized Troponin From Baseline to Percutaneous Coronary Intervention (PCI)|Standardized troponin is defined as the ratio of the assayed troponin value divided by the upper limit of normal (ULN). Least Squares (LS) means were obtained from an Analysis of Covariance (ANCOVA) model with treatment as a fixed effect and baseline standardized troponin as a covariate.|Baseline, before PCI (not greater than 48 hours after randomization)|All randomized participants who received at least 1 dose of study drug, had standardized troponin measured at baseline and before PCI (not greater than 48 hours after randomization).||ratio of assayed troponin/ULN||Standard Error|Least Squares Mean
807638|NCT01015287|Secondary|Percentage of Participants With All-cause Death, Myocardial Infarction (MI), Stroke, or All Coronary Artery Bypass Graft (CABG) and Non-CABG Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding Through 30 Days From First Loading Dose (LD)|The percentage of participants is the total number of participants experiencing an all-cause death, MI, stroke or CABG and non-CABG TIMI major bleeding divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.|First LD through 30 days after first LD|All randomized participants who received at least 1 dose of study drug.||percentage of participants|||Number
807639|NCT01015287|Secondary|Percentage of Participants With Incidence of Definite or Probable Stent Thrombosis (ST) According to the Academic Research Consortium (ARC) Criteria Through 30 Days From First Loading Dose (LD)|ARC criteria were used to define ST. Definite ST is angiographic or pathologic confirmation of partial or total thrombotic occlusion within the peri-stent region, and at least one of the following additional criteria: acute ischemic symptoms; ischemic electrocardiogram changes; elevated cardiac biomarkers. Probable ST is any unexplained death within 30 days of stent implantation; any MI, which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of ST and in the absence of any other obvious cause. The percentage of participants is the total number of participants experiencing a definite or probable stent thrombosis divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.|First LD through 30 days after first LD|All randomized participants who received at least 1 dose of study drug.||percentage of participants|||Number
807640|NCT01015287|Secondary|Percentage of Participants With Incidence of Cardiovascular (CV) Death Through 30 Days From First Loading Dose (LD)|The percentage of participants is the total number of participants experiencing a CV death divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.|First LD through 30 days after first LD|All randomized participants who received at least 1 dose of study drug.||percentage of participants|||Number
807641|NCT01015287|Secondary|Percentage of Participants With Incidence of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Urgent Revascularization (UR) Through 30 Days From First Loading Dose (LD)|The percentage of participants is the total number of participants experiencing a CV death, MI, or UR divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.|First LD through 30 days after first LD|All randomized participants who received at least 1 dose of study drug.||percentage of participants|||Number
808118|NCT01020123|Secondary|Leukocytes; Change From Baseline|Summary statistic of change from baseline|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 198 in CSR)||*10^3 cells/µL||Standard Deviation|Mean
807643|NCT01015287|Secondary|Percentage of Participants With Incidence of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Stroke Through 30 Days From First Loading Dose (LD)|The percentage of participants is the total number of participants experiencing a CV death, MI, or stroke divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.|First LD through 30 days after first LD|All randomized participants who received at least 1 dose of study drug.||percentage of participants|||Number
807644|NCT01015287|Secondary|Percentage of Participants With All-Cause Death, Myocardial Infarction (MI), Stroke, or All Coronary Artery Bypass Graft (CABG) and Non-CABG Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding|The percentage of participants is the total number of participants experiencing an all-cause death, MI, stroke or CABG and non-CABG TIMI major bleeding divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.|First loading dose (LD) through 7 days after first LD|All randomized participants who received at least 1 dose of study drug.||percentage of participants|||Number
807645|NCT01015287|Primary|The Percentage of Participants With Occurrence of Cardiovascular (CV) Death, Myocardial Infarction (MI), Stroke, Urgent Revascularization (UR), or Glycoprotein (GP) IIb/IIIa Inhibitor Bailout|The percentage of participants is the total number of participants experiencing a CV death, MI, stroke, UR or GPIIb/IIIa Inhibitor bailout divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.|First loading dose (LD) through 7 days after first LD|All randomized participants who received at least 1 dose of study drug.||percentage of participants|||Number
807646|NCT01015326|Primary|Qualitative Data From Patients and Experts to Measure Anti-EGFR Therapy-specific Health-related Quality of Life (HRQL)|"Patients were asked How important is this symptoms or concern to your quality of life? They were given a series of items (listed in the table) and instructed to assign each item a numerical value of 0 to 3, where 0 is equivalent to not at all important and 3 is equivalent to extremely important. Experts were asked How important is this symptom or concern to patients' quality of life? They were given the same series of items and instructed to assign each item a numerical value of 0 to 3, where 0 is equivalent to not at all important and 3 is equivalent to extremely important. For each item, a mean score was calculated using the values assigned to that item from all patients, and a second mean score was calculated using the values assigned to that item from all experts. An item's mean score may range from 0 to 3, where 0 is equivalent to not at all important to quality of life and where 3 is equivalent to extremely important to quality of life."|at time of questionnaire|Additional items that were variably collected and recorded have been omitted from the data set.||units on a scale||Standard Deviation|Mean
807647|NCT01015443|Secondary|Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death|An Adverse Event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A Serious Adverse Event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs were defined as the AEs that occur between first dose of study drug administration and 42 days after the last dose of study drug administration that were absent before treatment or that worsened relative to pretreatment state. Number of subjects with TEAE leading to death and permanent discontinuation of any trial treatment were presented.|From the first dose of study drug administration until 42 days after the last dose of study drug administration, assessed up to 5.6 years|Safety analysis set included all subjects who received at least one dose of trial treatment.||Subjects|||Number
807648|NCT01015443|Secondary|Time to Treatment Failure (TTF)|TTF was time from randomization to discontinuation of trial treatment for any reason as reported by the investigator. For subjects still receiving treatment at the time of analysis, the time between the date of randomization and the last date of treatment will be used as a censored observation in the analysis. Subjects who missed 2 consecutive scheduled doses without evaluable assessment for the related visits and who were lost to follow-up thereafter were considered treatment failure and the TTF was calculated from the date of randomization to the date of their first missed treatment.|From the date of randomization to the date of first missed treatment, assessed up to 5.6 years|The mITT analysis set was based on the ITT analysis set (ITT analysis set included all the subjects randomized into the study), but included only subjects with concurrent primary chemo-radiotherapy and prospectively excluded the 5 subjects who were randomized prior to the clinical hold.||Months||95% Confidence Interval|Median
807649|NCT01015443|Secondary|Progression Free Survival (PFS)|Time from randomization to objective disease progression (PD) as determined by the investigator or death. PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions from nadir, or the appearance of one or more new lesions as per RECIST version 1.0. Subjects who missed 2 consecutive scheduled doses without evaluable assessment for the related visits and who were lost to follow-up thereafter were considered as having PD, and the PFS was calculated from the date of randomization to the date of their first missed treatment. PFS time for subjects without an event was censored as of the date of last performed imaging.|From the date of randomization to PD, assessed up to 5.6 years|The mITT analysis set was based on the ITT analysis set (ITT analysis set included all the subjects randomized into the study), but included only subjects with concurrent primary chemo-radiotherapy and prospectively excluded the 5 subjects who were randomized prior to the clinical hold.||Months||95% Confidence Interval|Median
807659|NCT01015638|Secondary|Subject Assessment - Blistering|"At each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate blistering, burning, stinging, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 – None, 1 – Slight, 2 – Moderate, or 3 – Severe.
The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of blistering are presented here."|2 Weeks|||units on a scale||Standard Deviation|Mean
807756|NCT01026142|Secondary|Time to Progression (TTP) Based Upon Independent Review Facility (IRF) Assessment|Time to Progression (TTP) was defined as time between randomization and the first occurrence of progressive disease, based on IRF assessment.|Tumor assessments every 9 weeks from randomization until Week 27, then every 12 weeks thereafter, until IRF-determined PD, initiation of alternative anticancer medication, or death (up to 5.5 years).|All randomized participants.||Weeks||95% Confidence Interval|Median
807650|NCT01015443|Secondary|Time to Progression (TTP)|Time from randomization to radiological confirmation of disease progression (PD) as determined by the investigator. PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions from nadir, or the appearance of one or more new lesions as per RECIST version 1.0. For subjects without radiological confirmed PD who discontinued or died due to PD, the date of trial treatment discontinuation was used as event date. Subjects who missed 2 consecutive scheduled doses without evaluable assessment for the related visits and who were lost to follow-up thereafter were considered as having PD, TTP was calculated from the date of randomization to the date of their first missed treatment. Subjects without PD at time of analysis are censored at either date of last vaccination or death or discontinuation of treatment or lost to follow-up.|From the date of randomization to the date of radiological confirmation of PD, assessed up to 5.6 years|The mITT analysis set was based on the ITT analysis set (ITT analysis set included all the subjects randomized into the study), but included only subjects with concurrent primary chemo-radiotherapy and prospectively excluded the 5 subjects who were randomized prior to the clinical hold.||Months||95% Confidence Interval|Median
807651|NCT01015443|Secondary|Time to Symptom Progression (TTSP)|TTSP was measured from randomization to symptomatic progression by lung cancer symptom scale (LCSS) used to measure symptom changes relevant to quality of life (QoL).It consisted of 9 items focused on cancer symptoms (loss of appetite, fatigue, cough, shortness of breath, blood in sputum, pain, symptoms of cancer, illness affecting normal activity, QoL).For each symptom score distance from left boundary to point where subject has marked line was measured in millimeters (mm).Total scale length was 100 mm. Symptomatic progression was defined as increase/worsening of average symptomatic burden index (ASBI) (mean of 6 major lung cancer specific symptom scores);Worsening defined as 10% increase of scale breadth from baseline. Score 0 indicate no/minimum symptoms;100 indicates maximum level of symptoms. Subjects without symptomatic progression/lost to follow-up at time of analysis: time from date of randomization to date of last LCSS assessment was calculated & used as censored observation.|From the date of randomization to the date of symptomatic progression, assessed up to 5.6 years|The mITT analysis set was based on the ITT analysis set (ITT analysis set included all the subjects randomized into the study), but included only subjects with concurrent primary chemo-radiotherapy and prospectively excluded the 5 subjects who were randomized prior to the clinical hold.||Months||95% Confidence Interval|Median
807652|NCT01015443|Primary|Overall Survival (OS) Time|OS time was measured as the time (in months) between the date of randomization and the date of death. For subjects alive or lost to follow-up at time of analysis, the time between the date of randomization and the date on which the subject was last known alive was calculated and used as a censored observation in the analysis.|From the date of randomization until death, assessed up to 5.6 years|The modified intent-to-treat (mITT) analysis set was based on the intention-to-treat (ITT) analysis set (ITT analysis set included all the subjects randomized into the study), but included only subjects with concurrent primary chemo-radiotherapy and prospectively excluded the 5 subjects who were randomized prior to the clinical hold.||Months||95% Confidence Interval|Median
807653|NCT01015534|Secondary|Number of Grade 3-4 Adverse Events (AE) That Are Definitely or Probably Related to Both Groups of Treatment.|"AE, evaluated and graded according to the NCI common terminology criteria (NCI-CTCAE) v3.0
Grade 3 Severe AE.
Grade 4 Life-threatening or disabling AE."|4 months|Participants were assessed with a Complete blood count at the end of the first and second weeks of treatment. A standard biochemical profile was performed at the end of the second week of treatment, at 2 weeks after completion and at 2 months thereafter. Participants also were evaluated clinically with the same periodicity .||Events|||Number
807654|NCT01015534|Secondary|Overall Survival|Overall survival:Time in months measured from treatment initiation until the date of death or the date of last follow-up.|1 year|Data on all enrolled participants were included in an intention-to-treat analysis.||Months of Overall Survival||95% Confidence Interval|Median
807655|NCT01015534|Secondary|Survival Free of Brain Metastases Progression (PFS of BM)|Progression free survival of brain metastases is the survival of participants without progressive brain metastases or without neurological symptoms. The progressive brain metastases (PBM) were evaluated with cranial MRI. The PBM were defined as an increase of at least 20% in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new metastases.|at 90 days|Data on all enrolled participants were included in an intention-to-treat analysis.||Percentage of Participants||95% Confidence Interval|Number
807656|NCT01015534|Primary|Objective Response Rates. Assessed With Cranial MRI|"Objective Response (OR) encompassed the number of participants with Complete Response (CR) and the number of participants with Partial Response (PR). CR is the disappearance of all brain metastases, assessed between two or more cranial MRI. PR is at least a 30% decrease in the sum of the longest diameter of the brain metastases, taking as reference the baseline sum longest diameter, assessed between two or more cranial MRI.
Objective Response Rate (ORR) is the ratio between the number of participants with objective response and the total number of participants."|90 days|Data on all enrolled participants were included in an intention-to-treat analysis.||Percentage of participants with OR||95% Confidence Interval|Number
807657|NCT01015560|Primary|uNTX Response Rate at 43 Days|Urinary n-telopeptide (uNTX) response is defined as a 25% reduction from baseline levels. Patients with missing response data were included as non-responders.|43 days|Eligible and analyzable patients||percentage of participants||95% Confidence Interval|Number
807658|NCT01015638|Secondary|Subject Assessment - Oiliness|"At each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate oiliness, burning, stinging, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 – None, 1 – Slight, 2 – Moderate, or 3 – Severe.
The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of oiliness are presented here."|2 Weeks|||units on a scale||Standard Deviation|Mean
807672|NCT01015677|Primary|Number of Participants Who Discontinued Study Drug Due to an AE|An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to 4 weeks|The APaT population is all participants who received at least one dose of study drug.||Participants|||Number
807660|NCT01015638|Secondary|Subject Assessment - Crusting|"At each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate crusting, burning, stinging, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 – None, 1 – Slight, 2 – Moderate, or 3 – Severe.
The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of crusting are presented here."|2 Weeks|||units on a scale||Standard Deviation|Mean
807661|NCT01015638|Secondary|Subject Assessment - Pain|"At each visit, panelists were supplied a self-assessment questionnaire, which included assessment of pain.
Subjects were asked to evaluate burning, stinging, pain, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 – None, 1 – Slight, 2 – Moderate, or 3 – Severe.
The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of pain are presented here."|2 Weeks|||units on a scale||Standard Deviation|Mean
807662|NCT01015638|Secondary|Subject Assessment - Roughness|"At each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate burning, stinging, roughness, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 – None, 1 – Slight, 2 – Moderate, or 3 – Severe.
The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of roughness are presented here."|2 weeks|||units on a scale||Standard Deviation|Mean
807663|NCT01015638|Secondary|Subject Assessment - Dryness|"At each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate burning, stinging, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 – None, 1 – Slight, 2 – Moderate, or 3 – Severe.
The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of dryness are presented here."|2 weeks|||units on a scale||Standard Deviation|Mean
807664|NCT01015638|Secondary|Subject Tolerability - Stinging|"At each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate burning, stinging, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 – None,1 – Slight,2 – Moderate, or 3 – Severe.
The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of stinging are presented here."|2 weeks|||units on a scale||Standard Deviation|Mean
807665|NCT01015638|Secondary|Subject Tolerability - Burning|"At each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate burning, stinging, pain, and dryness in this questionnaire. Each symptom was rated with the following scale: 0 – None, 1 – Slight, 2 – Moderate, or 3 – Severe.
The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of burning are presented here."|2 weeks|ITT||units on a scale||Standard Deviation|Mean
807666|NCT01015638|Secondary|Changes in the Skin Surface Hydration|"The ability of an alternating current to flow through the stratum corneum is an indirect measure of its water content. The value recorded is expressed in microsiemens. Higher values indicate greater levels of skin hydration.
Test results were compared to measurements from the other side of the face, which was not treated instead of referring to a normal range. A normal range does not exist for this measurement. Instead, the non-treated side of the face was used as a control to determine the normal level of skin hydration."|14 days|ITT||microsiemens||Standard Deviation|Mean
807667|NCT01015638|Primary|Skin Dryness|"Visual Dryness was evaluated using the following scale:
Grade 0 = None 2 = Slight flaking 4 = Moderate flaking/scaling 6 = Marked scaling / slight fissuring 8 Severe scaling, fissuring"|14 days|ITT||units on a scale||Standard Deviation|Mean
807668|NCT01015638|Secondary|Skin Moisture and Hydration|"To assess skin moisture and hydration using transepidermal water loss (TEWL). Results are measured on a continuous scale as grams per meters squared (m^2) per hour. Higher values indicate greater water loss/ lower skin moisture levels.
Evaporative water loss measurements provide an instrumental assessment of skin barrier function(one of the layers of the skin. Damage leads to a disruption of the barrier that is accompanied by elevated water loss rates and affects skin moisture and hydration."|14 days|||grams/m^2/hour||Standard Deviation|Mean
807669|NCT01015638|Primary|Erythema (Redness)|"Compare tolerability of clindamycin and benzoyl peroxide (BPO) 5% and clindamycin phosphate and benzoyl peroxide 2.5% using visual assessments by an independent blinded grader.
Erythema (redness) was evaluated using the following scale:
Erythema Grade Description 0 = None 2 = Mild erythema 4 = Moderate confluent erythema 6 = Marked erythema with some edema 8 = Marked erythema, edema, possible erosion"|14 days|ITT||units on a scale||Standard Deviation|Mean
807670|NCT01015677|Secondary|Change From Baseline in Follicle-stimulating Hormone (FSH) Level at Week 4|FSH was measured to assess estrogen receptor (ER) selectivity (a biomarker for ERα activity and a pharmacodynamic endpoint).|Baseline and Week 4|The Per-Protocol (PP) population excludes participants due to important deviations from the protocol that may substantially affect the results of the primary and key secondary efficacy endpoints.||mIU/mL||90% Confidence Interval|Least Squares Mean
807671|NCT01015677|Secondary|Percent Change From Baseline in the Weekly Hot Flash Severity Score (Combining Severe and Very Severe Score) at Week 4|Hot flash severity score is calculated by the sum of: the number of mild hot flashes, 2 times number of moderate hot flashes, 3 times the number of severe hot flashes, and 4 times the number of very severe hot flashes. This sum was standardized to a 7-day week if there were any missing days in the e-diary. The severity of each hot flash was recorded by the Hot Flash e-diary.|Baseline and Week 4|The Full Analysis Set (FAS) population consists of all randomized participants who receive at least 1 dose of study treatment, have at least 1 post-randomization observation for the analysis endpoint, and have baseline data for those analyses.||Percent change||95% Confidence Interval|Least Squares Mean
807710|NCT01025232|Secondary|Determine Number of Patients Who Experience a Gain of 15 or More Letters From Baseline to Month 12 in ETDRS BCVA.||1 year|||participants|||Number
807673|NCT01015677|Primary|Number of Participants Who Experienced at Least One or More Adverse Events (AE)|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to 6 weeks|The All-Patients-as Treated (APaT) population is all participants who received at least one dose of study drug.||Participants|||Number
807674|NCT01015677|Primary|Percent Change From Baseline in the Number of Weekly Moderate to Very Severe Hot Flashes (Excluding Outliers) at Week 4|Hot flashes were recorded in real time and hot flashes recorded retrospectively in the morning and evening reports in a diary day via the Hot Flash e-diary were summed to determine the total number of hot flashes over a diary day. The total number of weekly moderate or worse hot flashes were calculated as the sum of the total number of hot flashes that occur over a diary week (non-missing diary day), divided by the number of days of diary completion, and multiplied by 7 (standardized week). At least 4 non-missing diary days were required to define the total number of weekly moderate or worse hot flashes. Hot flash data was excluded for participants whose number of moderate to severe hot flashes per week were in the top 1% of number of hot flashes reported to exclude any outlier effect.|Baseline and Week 4|The Full Analysis Set (FAS) population consists of all randomized participants who receive at least 1 dose of study treatment, have at least 1 post-randomization observation for the analysis endpoint, and have baseline data for those analyses.||Percent change||95% Confidence Interval|Least Squares Mean
807675|NCT01015703|Primary|Safety Events|Safety/tolerability study design of 5 doses of test article administered to healthy volunteers. Each dose was injected 21 days apart. Participants were withdrawn upon experiencing any adverse event.|Duration of study|||percentage of patients|||Number
807676|NCT01015781|Primary|Tinnitus Functional Index Change Score|"The Tinnitus Functional Index (TFI) is a tinnitus outcome measure that has been validated for “responsiveness” (Meikle et al., 2012). Prior to the TFI, no tinnitus questionnaire had been specifically designed and tested to maximize responsiveness to treatment-related change.
Completion of the 25-item TFI results in an index score that can range from 0 to 100, with higher scores reflecting greater problems associated with tinnitus. The following is a general guide to facilitate interpretation of TFI scores:
<25 = relatively mild tinnitus (little or no need for intervention)
25-50 = significant problems with tinnitus (possible need for intervention) •>50 = tinnitus severe enough to qualify for more aggressive intervention Data from the TFI development study (Meikle et al., 2012) suggest that a reduction in the TFI score of at least 13 points would indicate a clinical improvement that a patient would consider important or meaningful."|Baseline, 6 months (from Baseline)|"The analysis was intention to treat (ITT). Includes all subjects from whom both baseline and 6 month data were collected."||units on a scale||Standard Deviation|Mean
807678|NCT01015820|Primary|Mean Blood Vessel Radius (BVR)|BVR serves as a marker for early increase of blood supply (EIBS).|Completion of study procedure (endoscopic ultrasound), approximately 30 minutes from procedure initiation|Among the 15 participants in the cancer group, 1 participant was excluded from the final analysis due to suboptimal measurements. Therefore 14 participants in the cancer group and 15 participants in the control group were included in the analysis population.||cm||95% Confidence Interval|Mean
807679|NCT01015820|Primary|Deoxyhemoglobin Concentration (DHb)|Deoxygenated hemoglobin is the form of hemoglobin without the bound oxygen. It serves as a marker for early increase of blood supply (EIBS). DHb concentration was determined spectroscopically from five peri-ampullary locations.|Completion of study procedure (endoscopic ultrasound), approximately 30 minutes from procedure initiation|Among the 15 participants in the cancer group, 1 participant was excluded from the final analysis due to suboptimal measurements. Therefore 14 participants in the cancer group and 15 participants in the control group were included in the analysis population.||alpha units||95% Confidence Interval|Mean
807680|NCT01015976|Primary|AUC Post Surgery (n =5) Compared to AUC Control (n=5)|AUC of surgery group compared to the AUC of control group|0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5 hours|Per protocol||ng-hr/mL||Standard Deviation|Mean
807681|NCT01016015|Primary|Progression-free Survival Rate, Defined as CR + PR + SD, as Assessed by RECIST Criteria|From study entry until recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurement recorded on study), death or date of last contact, assessed at 12 weeks|From study entry until recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurement recorded on study), death or date of last contact, assessed at 12 weeks|||participants|||Number
807682|NCT01016067|Secondary|"Number of Subjects Having Additional Surgical Procedure Classified as a Treatment Failure"|Subject who had a surgery after the original study treatment was classified as a treatment “failure” if the additional surgery or treatment occurred in the involved limb and affected the study treatment and/or its mechanism of action in relation to the diagnosis or condition of the subject that was the cause for having the original study treatment.|12 months|||participants|||Number
807683|NCT01016067|Secondary|Success in Short Form 36-Item (SF-36) Health Survey|SF-36 was used to assess general health status. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). Success was defined as any improvement in a subject’s SF-36 PCS post-operatively as compared to the pre-operative condition.|12 months|||participants|||Number
807684|NCT01016067|Secondary|Success in Short Musculoskeletal Functional Assessment (SMFA)|The SMFA is an assessment tool that measures a subject’s overall function for a broad range of musculoskeletal injuries and disorders. The SMFA results were summarized into two components, the dysfunctional index and the bother index. Success for the SMFA assessment was defined as any improvement post-operatively as compared to the pre-operative condition.|12 months|||participants|||Number
807711|NCT01025232|Secondary|Determine Number of Patients Who Experience a Loss of 15 or More Letters From Baseline to Month 12 and Month 12 in ETDRS BCVA||1 year|||participants|||Number
807712|NCT01025232|Secondary|Evaluate the Incidence and Severity of Ocular and Non-ocular Adverse Events (AEs) Through Month 12||1 year|||Incidents|||Number
807685|NCT01016067|Secondary|Success of Pain Status at the Delayed Healing Site|After walking five or six steps, subjects rated their intensity of pain/discomfort at the delayed healing site using a numerical rating scale from 0-10, with a score of 0 representing “no pain” and a score of 10 representing “pain as bad as it could be”. Subjects who were unable or declined to walk because of severe leg pain were considered to have a score of 10. Success for pain at the delayed healing site was defined as at least a 2-point improvement in pain from the pre-operative score. Success of pain status at the delayed healing site was a component of overall success.|12 months|||participants|||Number
807686|NCT01016067|Secondary|Success in Weight Bearing Ability|Success in weight bearing ability (a component of overall success) was defined that subject was able to bear weight without severe pain on the affected limb. The subject was asked to stand, bearing full weight on the affected limb in a single-leg stance without ambulatory assistance for 10 seconds. If the subject was able to do so without severe pain, a positive (success) response was recorded. If the subject was either unable to stand on the affected limb in a single-leg stance or declined to do so because of limb weakness, poor balance, or severe leg pain, a negative (failure) response was documented.|12 months|||participants|||Number
807687|NCT01016067|Secondary|Radiographic Union Success|Radiographic union success (a component of overall success) was defined as complete disappearance of fracture lines or the presence of bridging bone across the delayed healing site as observed on at least three of the four cortices (anterior, posterior, medial, and lateral), using plain films. If there was more than one delayed healing fracture line, all fracture lines must have been united in order to be considered a successful fracture union.|12 months|||participants|||Number
807688|NCT01016067|Primary|Overall Success|Overall success is reported as participants who met all of the following criteria: 1. radiographic union success; 2. success in weight bearing ability; 3. improvement in pain at the delayed healing site; 4. no serious adverse event classified as “implant-associated” or “implant/surgical procedure-associated” (device-related); 5.no additional surgical procedures classified as a failure.|12 Months|"Ten investigational and 9 control subjects were evaluable for overall success while only 9 investigational and 8 control subjects completed the study at 12-month follow-up. Two subjects were classified as failure due to related serious adverse event or additional surgery before completion of the study."||participants|||Number
807689|NCT01016106|Primary|Heterozygous for Filaggrin (FLG) Null Mutations|Buccal swab samples were obtained from each subject. Deoxyribonucleic acid (DNA) was purified from buccal swabs (IsoHelix Swabs, BocaScientific, Boca Raton, FL) and quantified by ultraviolet spectrophotometry. Purified genomic DNA and controls were amplified by polymerase chain reaction (PCR) from three different regions of FLG exon 3 with three primer sets. PCR products were analyzed by electrophoresis, purified (Qiaquick, Qiagen, Valencia, CA), and subjected to duplicate cycle sequencing reactions using ABI BigDye v3.1 reagents (Applied Biosystems, Carlsbad, CA). Labeled sequencing products were purified for capillary electrophoresis (ABI3730 or ABI3130 sequencer with POP7 polymer), and sequence results were examined using ABI SeqScape software. All nucleotide changes were noted, including 30 single nucleotide polymorphism (SNPs) in the population tested, the most common of which were coding changes at T454A, H2507Q, and G2545R, and silent change at nucleotide t2508c.|1 month|||participants|||Number
807690|NCT01016132|Primary|Overall Preference|"Overall preference when comparing study lenses to habitual lenses, as interpreted by the participant and reported on a questionnaire as a single, retrospective evaluation of four weeks' wear time. Overall preference was measured on a 5-point Likert scale as follows: Strongly Prefer Study Lenses; Somewhat Prefer Study Lenses; No Preference; Somewhat Prefer Habitual Lenses; Strongly Prefer Habitual Lenses."|4 weeks of wear|Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Participants|||Number
807691|NCT01025037|Secondary|Isometric Strength||baseline, post-op months 6, 12, and 24|||newtons (N)||Standard Deviation|Mean
807692|NCT01025037|Primary|Simple Shoulder Test (SST)|"The Simple Shoulder Test (SST): a series of 12 yes or no questions the patient answers about the function of the involved shoulder; 2 questions relate to pain, 7 questions relate to function and 3 questions relate to range of motion. The answers to these questions (yes = 1, no = 0) provides a standardized way of recording the function of a shoulder before and after treatment (McClure & Michener, 2003). A score of 12 on the Simple Shoulder test represents the best possible outcome, while a score of 0 represents the worst possible outcome."|baseline, post-op months 3, 6, 12, and 24|||units on a scale||Standard Deviation|Mean
807693|NCT01025037|Primary|Adjusted Constant-Murley Score|The Constant-Murley Shoulder Score is a 100-point functional shoulder assessment tool in which higher scores reflect increased function. The subjective variables are pain (15 points) and function (Activities of Daily Living – sleep, work, recreation/sport) (20 points), for a total of 35 points. The objective variables are active range of motion (clinician assessment) (40 points) and strength (25 points), for a total of 65 points (Stiller & Uhl, 2005).|baseline, post-op months 6, 12, and 24|||units on a scale||Standard Deviation|Mean
807694|NCT01025037|Other Pre-specified|Incidence of Complications, Including Infection|Complications were summarized by reporting adverse events of special interest. AEs of special interest were defined as any reported infection (incision, wound, surgical site), seroma, hematoma, inflammation (surgical site, wound), and re-tear. The re-tear rate reported in this section is the number reported via AE or surgical intervention (not the MRI results). The AEs of special interest were chosen because they are in alignment with the potential complications listed on the product insert.|All time points|||percentage of participants|||Number
807695|NCT01025037|Secondary|Rotator Cuff Re-tear Evaluation|"Subjects will have MRI to assess healing of the repaired tendon at 6 and 12 months post-op. The rate of re-tear will be reported.
Two different definitions of a re-tear were used for the analysis.
Primary definition (used for analysis of the secondary objective): Full thickness tear that is 80% or greater in length of the original tear size.
Sub-analysis: Full thickness tear one centimeter or greater in length."|Post-op months 6 and 12|Participants were analyzed at 6 and 12 months post-op. 2 participants not analyzed due to exclusion prior to 6 month post op visit.||percentage of participants|||Number
807769|NCT01026220|Secondary|Event Free Survival|Survival from enrollment to first event: relapse/progression, second malignancy, or death.|At 3 years from enrollment|161 patients began consolidation therapy: 81 Group 2 Regimen I and 80 Group 3 Regimen II.||Probability of survival||95% Confidence Interval|Number
822942|NCT01165983|Secondary|Absolute Change in Biochemical Markers of Endothelial Function, C-reactive Protein, μg/mL||12 Weeks post-randomization|||μg/mL||Inter-Quartile Range|Median
807696|NCT01025037|Primary|American Shoulder and Elbow Score (ASES)|The ASES evaluation generally has a patient self-evaluation section and a physician assessment section. The patient self-evaluation section of the form contains visual analog scales for pain, instability, an activities of daily living (ADL) questionnaire. The physician assessment section includes an area to collect demographic information and assesses range of motion, specific physical signs, strength, and stability. A shoulder score can be derived from the visual analogue scale score for pain (50%) and the cumulative activities of daily living score (50%) (Richards, Bigliani, Gartsman, Iannotti, & Zuckerman, 1994). The ASES evaluation has a total of 100 points possible; with 100 being the best possible outcome, and 0 being the worst.|baseline, post-op months 3, 6, 12, and 24|||units on a scale||Standard Deviation|Mean
807697|NCT01025076|Primary|Primary Outcome: Change in Body Weight|Body weight changes at 6 months after StomaphyX procedure comparing to baseline weight.|At 6 months comparing to baseline weight|||kg||Standard Deviation|Mean
807698|NCT01025154|Primary|Median Event-Free Survival (EFS)|Event-free survival (EFS) defined as time from start of treatment to first documentation of disease relapse or death.|2 years|Two of the fifty-nine participants were not included in the analysis.||Months||Full Range|Median
807699|NCT01025154|Primary|Overall Response: Number of Participants With Complete Remission or Complete Remission Without Platelet Recovery|Overall Response (CR+CRp) defined as Complete remission (CR): Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count > 1.0 x 10^9/L and platelet count > 100 x 10^9/L, and normal bone marrow differential (< 5% blasts); and, Complete Remission without Platelet Recovery (CRp): Peripheral blood and bone marrow results as for CR, but with platelet counts of < 100 x 10^9/L. Response evaluated within 8 weeks after induction therapy.|8 weeks after Induction therapy (induction cycle 4-6 weeks)|Two of the fifty-nine participants were not evaluable.||participants|||Number
807700|NCT01025193|Secondary|Number of Participants With Treatment Related Serious Adverse Events|To assess the safety of belimumab in sensitized patients awaiting kidney transplant we evaluated the number of participants with serious adverse events possibly or definitely related to belimumab.|up to one year pre-transplant|Any patient who received at least one dose of belimumab was included in the analysis||Participants|||Count of Participants
807701|NCT01025193|Secondary|Hepatitis B Vaccine Antibody Titers|We investigated if belimumab treatment would decrease Hepatitis B vaccine titers by 12 months after treatment with belimumab. All patients received Hepatitis B vaccine before beginning treatment with belimumab.|up to 12 months of treatment with belimumab|All patients who received at least one dose of belimumab were included in the analysis||Participants|||Count of Participants
807702|NCT01025193|Secondary|BLyS Levels Before and After Treatment With Belimumab|We assessed for unexpected changes in bound and unbound BLyS levels before and after treatment with belimumab. These were measured from before treatment and at months 1,2,6,10 and 12 months after belimumab treatment and again at 8 weeks after belimumab treatment.|up to 8 weeks after completion of therapy|Any patient who received at least one dose of belimumab was included in the analysis||Participants|||Count of Participants
807703|NCT01025193|Secondary|B and T Lymphocyte Subsets|B and T Lymphocyte subsets were measured through flow cytometry pre-treatment and at months 1,2,12 and at 8 weeks after the last belimumab dose. We looked for clinically significant changes (as determined by Principal Investigator) in these subsets at each time-point.|8 weeks after the last dose of belimumab|Any patient who received at least one dose of belimumab was included in the analysis||Participants|||Count of Participants
807704|NCT01025193|Secondary|Pharmacokinetics of Belimumab Measured as Number of Participants With Specific Dilution Factors at Each Time Point.|We wanted to look at belimumab pharmacokinetics in sensitized patients awaiting kidney transplant. These are reported as number of participants with specific dilution factors at each studied time-point. Blood for these tests could be drawn pre dose as well as 0-4 hours after the dose was given. Belimumab dilutions factors were measured pre dose at timepoints 0 (first day of belimumab), days 56 and 364. Belimumab dilution factors were measured after the dose on days 14, and 168. Belimumab dilution factors were also measured at 8 weeks after completion of belimumab therapy and pre dose at any unscheduled visits if needed.|Belimumab serum drug dilution factors were measured in patients at at timepoints 0 (first day of belimumab), day 14, day 56, day 168, 364, at any unscheduled visits, and at 8 weeks post completion of belimumab therapy.|any patient who received at least one dose of belimumab was included in the analysis||Participants|||Count of Participants
807705|NCT01025193|Primary|Successful Kidney Transplantation From a Cross-match Compatible Donor (as a Result of Belimumab Therapy)|In order for a sensitized recipient ( a recipient with antibodies) to be transplanted, the cross match with the donor has to be compatible. We wanted to study if belimumab reduced antibodies in sensitized patients and led those patients to subsequently become cross-match compatible with a donor and allow for successful transplant.|one year pre-transplant|All participants enrolled who received at least one dose of belimumab were considered for analysis.||Participants|||Count of Participants
807706|NCT01025193|Primary|Effectiveness of Belimumab to Normalize Allo-antibody Levels in Sensitized Patients Awaiting Kidney Transplantation.|Before transplant it is necessary to measure antibodies that the recipient might have and compare them to the living or decease donor's immune make-up. Recipients with many antibodies or a specific antibody in a high concentration may have a more difficult time finding a compatible donor, and being transplanted. These recipients are referred to as sensitized patients. It is important that the sensitized recipient and the donor be compatible to prevent rejection after transplant. We measured antibodies levels in sensitized patients waiting for kidney transplant, to see if belimumab would decrease these antibody levels.|up to one year pre-transplant|any patient who received at least one dose of belimumab was included in analysis population||Participants|||Count of Participants
807707|NCT01025232|Secondary|Evaluate the Relationship Between Specific Genetic Polymorphisms Associated With AMD, Disease Characteristics and Processes, and Response to Intravitreal Ranibizumab||1 year|Given lack of clinical benefit of 2.0 mg ranibizumab, as demonstrated in the HARBOR trial [Busbee BG, et al. (2013) Ophthalmology 120(5), 1046-1056], further secondary analyses were suspended.|||||
807708|NCT01025232|Secondary|Assess Number of Ranibizumab Injections in Each of the Two Doses Required Through Month 12||1 year|||number of injection||Standard Deviation|Mean
807709|NCT01025232|Secondary|Evaluate Mean Change in Central Retinal Thickness Over Time Through Month12 as Assessed by All Three OCTs (Stratus, Cirrus, and Spectralis)||1 year|||micrometer||Standard Deviation|Mean
807713|NCT01025232|Primary|Mean Change From Baseline in ETDRS BCVA at Month 12 (Fixed Interval Dosing Primary Endpoint After 3 Monthly Doses. Variable Interval Dosing Primary Endpoint at 1 Year.)|Early Treatment Diabetic Retinopathy Study Best Corrected Visual Acuity (ETDRS BCVA) was used to quantify visual acuity. BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|1 Year|||ETDRS BCVA Letters||Standard Error|Mean
807714|NCT01025271|Secondary|Characterize the CSF and Plasma Concentration-time Profile of Daptomycin in Patients With External Ventricular Drain (EVD) to Determine the CSF Penetration and Pharmacokinetic Parameters in This Patient Population (|no analysis completed|5 years||||||
807715|NCT01025271|Primary|Characterize the CSF and Plasma Concentration-time Profile of Daptomycin in Patients With External Ventricular Drain (EVD) Related Meningitis|unable to meet enrollment no data available. Study terminated early|5 years|unable to meet enrollment no data available. Study terminated early|||||
807787|NCT01026402|Secondary|Percent Change From Baseline in pAKT (S473) in Platelet Rich Plasma (PRP) at 2 Hours Post Dose|Phosphorylation levels of AKT from PRP (Patients with undetectable values at baseline have been excluded)|predose and 2 hours after a single dose|Efficacy analysis set||Percent change||Full Range|Median
807737|NCT01026012|Primary|Number of Participants With Side Effects, Including Dyspnea, Headache, Dizziness, Chest Pain, Nausea, Abdominal Discomfort, Dysgeusia, Flushing, and Symptomatic Hypotension and Others.|Side effect will be monitored/reported by subject during stress test and 30 mins in recovery.( 1-2 hours total: for the during the subject was in the office for the test)|During and 30 minutes after stress test|Subjects whom completed the combined stress test, including imaging||participants|||Number
807738|NCT01026038|Post-Hoc|Percentage of Participants Achieving OPA GMTs With at Least Lower Limit of Quantification (LLOQ) 1 Month After Single Dose of 13vPnC Vaccine|Percentage of participants achieving OPA GMTs with at least LLOQ for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) determined in blood samples of all participants using mcOPA assay. Exact 2-sided CI based on observed proportion of participants. LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43; Pn7F, 210; Pn09V, 345; Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; Pn23F, 13. LOD established as lowest titer possible in assay, which was 8. OPA titers below LLOQ set to 0.5*LOD for analysis.|One month after vaccination|Evaluable immunogenicity population. N= number of participants analyzed within a given treatment group. n= number of participants with a determinate OPA antibody titer to the given serotype.||Percentage of Participants||95% Confidence Interval|Number
807739|NCT01026038|Secondary|Percentage of Participants With at Least 1/2048 OPA GMTs for Serotype 7F After Single Dose of 13vPnC Vaccine|Percentage of participants with at least 1/2048 serotype-specific pneumococcal OPA GMTs for serotype 7F determined in the blood samples of all participants.|One month after vaccination|The data was not collected as planned as the additional, more stringent qualification and validation of the improved mcOPA assays used in this study did not support 1/2048 for serotype 7F for the quantitation of a serum response and thus the established LLOQ was used for the mcOPA assay.||Percentage of Participants||95% Confidence Interval|Number
807740|NCT01026038|Secondary|Percentage of Participants With at Least 1/8 Serotype-specific OPA GMTs After Single Dose of 13vPnC Vaccine|Percentage of participants with at least 1/8 serotype-specific pneumococcal OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) determined in the blood samples of all participants.|One month after vaccination|The data was not collected as planned as the additional, more stringent qualification and validation of the improved mcOPA assays used in this study did not support 1/8 for the quantitation of a serum response and thus the established LLOQ was used for the mcOPA assay.||Percentage of Participants||95% Confidence Interval|Number
807741|NCT01026038|Secondary|Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine|Serotype-specific pneumococcal OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using mcOPA assay. CIs for GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|One month after vaccination|Evaluable immunogenicity population. N= number of participants analyzed within a given treatment group. n= number of participants with a determinate OPA antibody titer to the given serotype.||Geometric mean titers||95% Confidence Interval|Geometric Mean
807742|NCT01026038|Secondary|Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine|Pneumococcal OPA GMTs for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using a microcolony OPA (mcOPA) assay. CIs for GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|Up to 7 days before vaccination|Evaluable immunogenicity population. N= number of participants analyzed within a given treatment group. n= number of participants with a determinate OPA antibody titer to the given serotype.||Geometric mean titers||95% Confidence Interval|Geometric Mean
807755|NCT01026142|Secondary|Time to Treatment Failure (TTF) Based Upon Independent Review Facility (IRF) Assessment|Time to Treatment Failure (TTF) was defined as time between randomization and date of disease progression based on independent review, death, or withdrawal of treatment due to adverse events, withdrawn informed consent, refusal of treatment/failure to cooperate, or failure to return, whichever occurred first.|Tumor assessments every 9 weeks from randomization until Week 27, then every 12 weeks thereafter, until IRF-determined PD, initiation of alternative anticancer medication, or death (up to 5.5 years).|All randomized participants.||Weeks||95% Confidence Interval|Median
807743|NCT01026038|Secondary|Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine|IgG GMC to the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using a standardized anti-pneumococcal IgG ELISA. CIs for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Four to seven days after vaccination|Evaluable immunogenicity population: eligible participants, randomized, blood drawn within required timeframes, at least 1 valid and determinate assay result for proposed analysis, received no prohibited vaccines, no major protocol violations. N= number of participants with determinate IgG antibody concentration to serotype.||mcg/mL||95% Confidence Interval|Geometric Mean
807744|NCT01026038|Secondary|Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine|IgG GMC to the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using a standardized anti-pneumococcal IgG enzymelinked immunosorbent assay (ELISA). CIs for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Up to 7 days before vaccination|Evaluable immunogenicity population: eligible participants, randomized, blood drawn within required timeframes, at least 1 valid and determinate assay result for proposed analysis, received no prohibited vaccines, no major protocol violations. N= number of participants with determinate IgG antibody concentration to serotype.||mcg/mL||95% Confidence Interval|Geometric Mean
807745|NCT01026038|Primary|Percentage of Participants With Prespecified Systemic Events|Systemic events (any fever >= 38 degree celsius [C], vomiting, diarrhea, and fatigue) were reported using electronic diary. Fever categorized as >=38 to <=39 degree C; >39 to <=40 degree C; >40 degree C. Vomiting: mild (1-2 times/day ); moderate (>2 times/day); severe (requires intravenous hydration). Diarrhea: mild (2-3 loose stools/day); moderate (4-5 stools/day); severe (>=6 loose stools/day). Fatigue: mild (does not interfere with activity); moderate (some interference with activity); severe (prevents daily routine activity). Participants may be reported in more than 1 category.|Seven days after vaccination|"Safety population: all participants who received the single dose of 13vPnC vaccination. n is signifying number of participants reporting yes for at least 1 day or no for all days, for each group, respectively."||Percentage of Participants|||Number
807746|NCT01026038|Primary|Percentage of Participants With Prespecified Local Reactions|Local reactions (redness, swelling and pain) were reported using electronic diary. Redness and swelling were recorded in caliper units (range 1 to 14+), each caliper unit represented 0.5 cm. Categorized as any, absent (no redness or swelling present; 0 caliper units), mild (0.5 to 2.0 cm; 1 to 4 caliper units); moderate (2.5 to 7.0 cm; 5 to 14 caliper units); or severe (>7.0 cm; >14 caliper units). Pain was categorized as any, mild: does not interfere with activity; moderate: interferes with activity; severe: prevents daily activity. Participants may be reported in more than 1 category.|Seven days after vaccination|"Safety population: all participants who received the single dose of 13vPnC vaccination. n is signifying number of participants reporting yes for at least 1 day or no for all days, for each group, respectively."||Percentage of Participants|||Number
807747|NCT01026038|Primary|Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine|Antibody GMC as measured by microgram/millilitre (mcg/mL) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.|One month after vaccination|Evaluable immunogenicity population: eligible participants, randomized, blood drawn within required timeframes, at least 1 valid and determinate assay result for proposed analysis, received no prohibited vaccines, no major protocol violations. N= number of participants with determinate IgG antibody concentration to serotype.||mcg/mL||95% Confidence Interval|Geometric Mean
807748|NCT01026103|Secondary|Incidence of Serosal Tearing||30 days post op|||participants|||Number
807749|NCT01026103|Secondary|Length of Hospital Stay||Date of discharge which averages 3 days|||days||Standard Deviation|Mean
807750|NCT01026103|Secondary|Incidence of Intra-operative Bleeding Requiring Intervention||Day 0 and 1 month|||participants|||Number
807751|NCT01026103|Primary|Proportion of Patients With an Uneventful Creation of a Functional Staple Line||Day 0|||participants|||Number
807752|NCT01026142|Secondary|Duration of Objective Response|Duration of Objective Response was defined for the subpopulation of responders as time from first Independent Review Facility (IRF)-assessed complete response (CR) or partial response (PR) to subsequent first documented, IRF-confirmed evidence of disease progression. Only participants with an objective response were included in the analysis of duration of objective response.|Tumor assessments every 9 weeks from randomization until Week 27, then every 12 weeks thereafter, until IRF-determined PD, initiation of alternative anticancer medication, or death (up to 5.5 years).|||Weeks||95% Confidence Interval|Median
807753|NCT01026142|Secondary|Clinical Benefit Rate (CBR)|Clinical Benefit Rate is based upon Independent Review Facility (IRF) assessments; defined as the percentage of participants a complete response (CR), partial response (PR), or stable disease for at least 8 cycles or 6 months.|Tumor assessments every 9 weeks from randomization until Week 27, then every 12 weeks thereafter, until IRF-determined PD, initiation of alternative anticancer medication, or death (up to 5.5 years).|Participants without a post-baseline tumor assessment were considered to be non-responders and were not included in this outcome measure.||Percentage of participants||95% Confidence Interval|Number
807754|NCT01026142|Secondary|Overall Objective Response Rate (ORR) Based Upon Independent Review Facility (IRF) Assessment|Overall Objective Response Rate is based upon investigator and IRF assessments. Objective Response Rate (ORR) was defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) among those who had measurable disease at baseline. CR was defined as the disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|Tumor assessments every 9 weeks from randomization until Week 27, then every 12 weeks thereafter, until IRF-determined PD, initiation of alternative anticancer medication, or death (up to 5.5 years).|Participants without a post-baseline tumor assessment were considered to be non-responders and were not included in this outcome measure.||Percentage of participants|||Number
807757|NCT01026142|Secondary|Investigator Assessment Progression-Free Survival (PFS)|Investigator Assessment Progression-Free Survival (PFS) was defined as the time from randomization to the first documented progressive disease, as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.0, or death from any cause, whichever occurred first. PD is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|Tumor assessments every 9 weeks from randomization until Week 27, then every 12 weeks thereafter, until IRF-determined PD, initiation of alternative anticancer medication, or death (up to 5.5 years).|All randomized participants.||Months||95% Confidence Interval|Median
807758|NCT01026142|Secondary|Overall Survival (OS) Rate Based on a 2-year Truncated Analysis|The Overall Survival (OS) rate is the percentage of participants who were surviving at the 2-year analysis. OS is defined as the time from the date of randomization to the date of death from any cause, with censoring of all events and follow-up beyond the end of the second year.|From randomization until death from any cause, up to 2 years|All randomized participants.||Percentage of participants||95% Confidence Interval|Number
807759|NCT01026142|Secondary|Overall Survival (OS)|Overall Survival (OS) was defined as the time from the date of randomization to the date of death from any cause. An interim analysis of OS (when approximately 200 deaths had occurred) was performed at the time of the analysis of the primary endpoint, Independent Review Facility (IRF)-assessed Progression-Free Survival (PFS), with type 1 error control. The final OS analysis will take place at the end of study when 67% of participants have died (approximately 300 deaths). Prior to the final data analysis cut-off, it will be ensured that all participants who are in survival follow-up have been contacted as recently as possible within the last 3 months to confirm current survival status.|From randomization until death from any cause, estimated to occur within 21 months after last patient randomized. This interim analysis data cut-off was 5.5 years.|All randomized participants.||Months||95% Confidence Interval|Median
807760|NCT01026142|Primary|Progression Free Survival (Independent Assessment)|Progression Free Survival (PFS) was defined as the time from randomization to first documented disease progression (PD), as determined by an Independent Review Facility (IRF) using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. IRF review of tumor assessment ceased after the primary PFS analysis. The primary endpoint was analyzed after approximately 337 IRF-assessed PFS events were observed.|Tumor assessments every 9 weeks from randomization until Week 27, then every 12 weeks thereafter, until IRF-determined PD, initiation of alternative anticancer medication, or death (up to 5.5 years).|All randomized participants.||months||95% Confidence Interval|Median
807761|NCT01026181|Primary|Change in BMI|"Patients' weight and height were measured at follow up visit 2 years post operation.
BMI was calculated using the formula: weight (kg)/height(meter)^2"|from baseline to 2-year postoperation|||kg/m^2||Standard Deviation|Mean
807762|NCT01026181|Primary|Change in Body Weight|Change of body weight in Kilograms measured at follow-up visits two year after surgery|baseline to 2-year postoperation|||kg||Standard Deviation|Mean
807763|NCT01026194|Secondary|Change From Baseline in 2-hour Postprandial Plasma Glucose at Week 12|The change from Baseline in 2-hour Postprandial Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline 2-hour Postprandial Plasma Glucose as a covariate.|at Week 0 and Week 12|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization.||mg / dL||Standard Error|Least Squares Mean
807764|NCT01026194|Secondary|Change From Baseline in the Areas Under the Curve From 0 to 2 h (AUC0–2h) for Postprandial Plasma Glucose at Week 12|The change from Baseline in AUC0–2h for Postprandial Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline AUC0–2h for Postprandial Plasma Glucose as a covariate.|0, 0.5, 1, 2 hours post-dose at Week 0 and Week 12|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization.||mg*h / dL||Standard Error|Least Squares Mean
807765|NCT01026194|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 12|The change from Baseline in Fasting Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline Fasting Plasma Glucose as a covariate.|at Week 0 and Week 12|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization. Analysis based on last observation carried forward, where the last postbaseline double-blind observed value was carried forward and used for Week 12 where data was missing.||mg / dL||Standard Error|Least Squares Mean
807766|NCT01026194|Primary|Change From Baseline in HbA1c at Week 12|The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate.|at Week 0 and Week 12|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization. Analysis based on last observation carried forward, where the last postbaseline double-blind observed value was carried forward and used for Week 12 where data was missing.||Percent of HbA1c||Standard Error|Least Squares Mean
807767|NCT01026220|Secondary|Overall Survival|Survival from enrollment to death.|At 3 years from enrollment|164 Group 1 All Patients received induction therapy. 161 patients began consolidation therapy: 81 Group 2 Regimen I and 80 Group 3 Regimen II.||Probability of survival||95% Confidence Interval|Number
807768|NCT01026220|Secondary|Grade 3 and 4 Non-hematologic Toxicities During Protocol Therapy|The number of patients that experience Common Terminology Criteria (CTC) Version 4 grade 3 or higher non-hematologic toxicity at any time during protocol therapy.|During and after completion of study treatment.|165 eligible patients.||participants|||Number
807770|NCT01026220|Secondary|Relapse-free Survival|A description, survival to relapse, of patterns of relapse after Doxorubicin, Bleomycin, Vincristine, Etoposide - Prednisone, Cyclophosphamide (ABVE-PC) and risk-adapted radiotherapy.|3 years from enrollment|161 patients began consolidation therapy: 126 patients received risk-adapted radiotherapy after consolidation therapy ABVE-PC and 35 did not.||Probability of survival||95% Confidence Interval|Number
807771|NCT01026220|Secondary|Event-free Survival for Rapid Early Response (RER) Positron Emission Tomography(PET)-1 Positive, RER PET-1 Negative|To investigate whether very early response assessment measured by Fluorodeoxyglucose-PET after 1 cycle of chemotherapy identifies a subject cohort that can be studied in future trials and that is distinguishable from currently defined RER after 2 cycles.|3 years from enrollment|RER with positive PET-1, Event-Free Survival for RER PET-1 positive patients is compared to that of RER with negative PET-1: n=57 PET-1 positive RER patients, compared to 2 events among n=20 PET-1 negative RER patients. Two PET-1 equivocal RER patients (1 with relapse and 1 censored) are not included in this analysis.||Probability of survival||95% Confidence Interval|Number
807772|NCT01026220|Secondary|Second-event-free Survival|Second event here is defined as any relapse/progression of Hodgkin Lymphoma (HL) or a previously reported second malignant neoplasm (SMN), a new SMN, or death after a first event which can be relapse/progression of HL, SMN, biopsy-proven HL following completion of Consolidation for Slow Early Response (SER) patient, positive bilateral bone marrow biopsy following completion of Consolidation for Stage IV patient, or death. If death occurs as the 1st event, it also counts as the 2nd event.|At 4 years from enrollment|This analysis excludes n=20 patients who had protocol early terminations or deviations (n=4 Regimen I, n=12 Regimen II, and n=4 Induction only).||Probability of survival||95% Confidence Interval|Number
807773|NCT01026220|Secondary|Event Free Survival|Survival from enrollment to first event: relapse/progression, second malignancy, or death.|At 3 years from enrollment|164 Group 1 All Patients received induction therapy.||Probability of survival||95% Confidence Interval|Number
807774|NCT01026220|Primary|Safety Analysis and Monitoring of Toxic Death|The primary endpoint for safety analysis and monitoring is toxic death, which is death primarily attributable to treatment.|Within 30 days of protocol treatment at median follow-up of 48 months (range: 1 to 70 months).|The six patients who received induction and reported death. The analysis here examines whether their death is primarily attributable to treatment or not.||participants|||Number
807775|NCT01026220|Primary|Second-event-free Survival|Second event here is defined as any relapse/progression of Hodgkin Lymphoma (HL) or a previously reported second malignant neoplasm (SMN), a new SMN, or death after a first event which can be relapse/progression of HL, SMN, biopsy-proven HL following completion of Consolidation for Slow Early Response (SER) patient, positive bilateral bone marrow biopsy following completion of Consolidation for Stage IV patient, or death. If death occurs as the 1st event, it also counts as the 2nd event.|At 4 years from enrollment|This analysis excludes n=20 patients who had protocol early terminations or deviations (n=4 Regimen I, n=12 Regimen II, and n=4 Induction only).||Probability of survival||95% Confidence Interval|Number
807776|NCT01026324|Secondary|Progression-free Survival||Up to 6 months|||participants|||Number
807777|NCT01026324|Primary|Percentage of Patients Alive (Phase II)|Due to difficult accrual to the trial, enrollment was ended early without entering into Phase II|Up to 1 year|Due to difficult accrual to the trial, enrollment was ended early without entering into Phase II|||||
807778|NCT01026324|Primary|Recommended Phase-2 Dose of SCH727965|Due to difficult accrual to the trial, enrollment was ended early without determination of an MTD.|14 days|Due to difficult accrual to the trial, enrollment was ended early without determination of an MTD.|||||
807779|NCT01026389|Secondary|Sensitivity|sensitivity of Dotarem® and Gadovist®-enhanced MRA examinations at the segment and the patient levels (gold standard = x-ray angiography) in on-site; moderate, severe stenosis and occlusion were grouped as one class (significant stenosis = positive segment).|up to one month|Per protocol population||positive segment with MRA|Participants||Number
807780|NCT01026389|Secondary|Specificity|Specificity of Dotarem® and Gadovist®-enhanced MRA examinations at the segment and the patient levels (gold standard = x-ray angiography) in on-site readings; no stenosis and non significant stenosis were grouped as one class (non significant stenosis = negative segment).|up to one month|per protocol population||negative segments in MRA|Participants||Number
807781|NCT01026389|Secondary|Intra-patient Accuracy, in Off-site Readings|• Intra-patient accuracy (percent agreement) of each type of MRA examination (Dotarem® or Gadovist®-enhanced MRA) in assessing the lesions of the concerned territory as compared with the gold standard, X-ray angiography, in off-site readings, using the same methodology as that used for the primary criterion|up to one month|"Ecah images from each patient were analysed by two external readers, this means that each patient was analyzed twice.
Per protocol population"||percentage of agreement|Participants|Standard Deviation|Mean
807782|NCT01026389|Primary|Intra-patient Accuracy (Percent Agreement), On-site Data|intra-patient accuracy (percent agreement) of each type of MRA examination (Dotarem® or Gadovist®-enhanced MRA) in assessing the lesions of the concerned territory as compared with the gold standard, X-ray angiography.|up to one month|Per protocol population||percentage of agreement||Standard Deviation|Mean
807783|NCT01026402|Secondary|Complete Metabolic Response (CMR), Cycle 2|Complete metabolic responses measured by 2-[F-18]-fluoro-2-deoxy-D-glucose positron emission tomography (FDG-PET) (or FDG-PET/Computed Tomography (CT)) with a comparison to baseline (pre-dose)|Cycle 2 Day 8|Efficacy analysis set||Participants|||Number
807784|NCT01026402|Secondary|Complete Metabolic Response (CMR), Cycle 1|Complete metabolic responses measured by 2-[F-18]-fluoro-2-deoxy-D-glucose positron emission tomography (FDG-PET) (or FDG-PET/Computed Tomography (CT)) with a comparison to baseline (pre-dose)|Cycle 1 Day 8|Efficacy analysis set||Participants|||Number
807785|NCT01026402|Secondary|Partial Metabolic Response (PMR), Cycle 2|Partial metabolic responses measured by 2-[F-18]-fluoro-2-deoxy-D-glucose positron emission tomography (FDG-PET) (or FDG-PET/Computed Tomography (CT)) with a comparison to baseline (pre-dose)|Cycle 2 Day 8|Efficacy analysis set||Participants|||Number
807786|NCT01026402|Secondary|Partial Metabolic Response (PMR), Cycle 1|Partial metabolic responses measured by 2-[F-18]-fluoro-2-deoxy-D-glucose positron emission tomography (FDG-PET) (or FDG-PET/Computed Tomography (CT)) with a comparison to baseline (pre-dose)|Cycle 1 Day 8|Efficacy analysis set||Participants|||Number
808119|NCT01020123|Secondary|Haemoglobin; Change From Baseline|Summary statistic of change from baseline|baseline to 4 month|population is safety analysis set regardless of rescue, using the observed cases (see table 197 in CSR)||g/dL||Standard Deviation|Mean
807789|NCT01026402|Secondary|Urine PK - Renal Clearance (Renal CL) at Steady State|Renal Clearance (n varies between PK outcome measures as a subset of the PK analysis set was used with reportable AZD2014 plasma concentrations and PK parameters at that visit who have no important adverse events or protocol deviations that may impact PK at that visit, which means that different amounts of data were available for different parameters depending on what visits the parameter covered)|Pre dose through to 24 hours post dose|PK analysis set||L/h||Standard Deviation|Mean
807790|NCT01026402|Secondary|Urine PK - Renal Clearance (Renal CL) Single Dose|Renal Clearance (n varies between PK outcome measures as a subset of the PK analysis set was used with reportable AZD2014 plasma concentrations and PK parameters at that visit who have no important adverse events or protocol deviations that may impact PK at that visit, which means that different amounts of data were available for different parameters depending on what visits the parameter covered)|Pre dose through to 24 hours post dose|PK analysis set||L/h||Standard Deviation|Mean
807791|NCT01026402|Secondary|Urine PK - Fraction Dose Excreted (fe(0-12)) at Steady State|Fraction dose excreted unchanged in the urine from 0-12 hours after dosing (n varies between PK outcome measures as a subset of the PK analysis set was used with reportable AZD2014 plasma concentrations and PK parameters at that visit who have no important adverse events or protocol deviations that may impact PK at that visit, which means that different amounts of data were available for different parameters depending on what visits the parameter covered)|Pre dose through to 24 hours post dose|PK analysis set - A subset of Safety Analysis set who have reportable plasma concentrations and PK parameter data and who have no important protocol deviations/AEs that may impact PK||Percent concentration||Standard Deviation|Mean
807792|NCT01026402|Secondary|Urine PK - Fraction Dose Excreted (fe(0-12)) Single Dose|Fraction dose excreted unchanged in the urine from 0-12 hours after a single dose (n varies between PK outcome measures as a subset of the PK analysis set was used with reportable AZD2014 plasma concentrations and PK parameters at that visit who have no important adverse events or protocol deviations that may impact PK at that visit, which means that different amounts of data were available for different parameters depending on what visits the parameter covered)|Pre dose through to 12 hours post dose|PK analysis set - A subset of Safety Analysis set who have reportable plasma concentrations and PK parameter data and who have no important protocol deviations/AEs that may impact PK||Percent concentration||Standard Deviation|Mean
807793|NCT01026402|Secondary|Area Under the Curve (AUC) at Steady State|AUC at steady state Continuous dosing - AUCss used Intermittent dosing - Weekly AUC used (n varies between PK outcome measures as a subset of the PK analysis set was used with reportable AZD2014 plasma concentrations and PK parameters at that visit who have no important adverse events or protocol deviations that may impact PK at that visit, which means that different amounts of data were available for different parameters depending on what visits the parameter covered)|Multiple dosing to steady state (up to 12 or 48 hours post dose)|PK analysis set||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
807794|NCT01026402|Secondary|Maximum Concentration (Cmax) at Steady State|Cmax at steady state (n varies between PK outcome measures as a subset of the PK analysis set was used with reportable AZD2014 plasma concentrations and PK parameters at that visit who have no important adverse events or protocol deviations that may impact PK at that visit, which means that different amounts of data were available for different parameters depending on what visits the parameter covered)|Multiple dosing to steady state (up to 12 or 48 hours post dose)|PK analysis set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
807795|NCT01026402|Secondary|Area Under the Curve (AUC) Single Dose|Area under the curve following single dose Continuous dosing - AUC parameter used Intermittent dosing - AUC(0-12) used (n varies between PK outcome measures as a subset of the PK analysis set was used with reportable AZD2014 plasma concentrations and PK parameters at that visit who have no important adverse events or protocol deviations that may impact PK at that visit, which means that different amounts of data were available for different parameters depending on what visits the parameter covered)|Following Single Dose up to 12, 24 or 48 hours post dose|PK analysis set||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
807796|NCT01026402|Secondary|Maximum Concentration (Cmax) Single Dose|Maximum concentration following single dose (n varies between PK outcome measures as a subset of the PK analysis set was used with reportable AZD2014 plasma concentrations and PK parameters at that visit who have no important adverse events or protocol deviations that may impact PK at that visit, which means that different amounts of data were available for different parameters depending on what visits the parameter covered)|Following Single Dose up to 12, 24 or 48 hours post dose|PK analysis set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
807797|NCT01026402|Secondary|Best Objective Response|Best Objective Response per Response Evaluation Criteria in Solid Tumours Criteria (RECIST) 1.1 for target and non target lesions assessed by CT, MRI or X-ray; Complete Response (CR), Disappearance of all target lesions since baseline; Partial Response (PR), At least a 30 percent decrease in the sum of diameters of target lesions; Progressive Disease (PD), At least a 20 percent increase in the sum of diameters of target lesions and an absolute increase of at least 5mm|Assessed every 8 weeks until progression or withdrawal, whichever came first, estimated to be up to 4 months|Efficacy analysis set - Patients who received at least 1 dose of AZD2014 and have a baseline tumour assessment||Participants|||Number
807798|NCT01026402|Primary|Number of Participants With Dose Limiting Toxicities (DLTs)|Maximum Tolerated Dose (MTD) was determined by testing various doses and schedules of AZD2014 in cohorts of 3-6 evaluable patients. MTD reflects the highest dose of drug at each schedule that did not cause a DLT in >1 patient|Up to 21 days from first multiple dose|Safety Analysis Set - All patients that received at least 1 dose of AZD2014. This includes dosed patients who are not evaluable for dose escalation decision purposes.||Participants|||Number
807799|NCT01026454|Secondary|Safety of Valacyclovir 1.5 Gram Orally Twice Daily in HIV-1 Seropositive Persons.||28 weeks||||||
807800|NCT01026454|Primary|Mean Level of HIV-1 RNA in Plasma of Participants While on Acyclovir or Valacyclovir.|Mean level of HIV-1 RNA in plasma of participants while on 400 mg twice daily of acyclovir versus while on 1.5 g twice daily of valacyclovir.|Weekly for 12 weeks per intervention|||log10 copies/mL||95% Confidence Interval|Mean
807826|NCT01026818|Secondary|Global Assessment Question (GAQ) Question 2 at Month 13.5|GAQ Question 2: Choose the one number which best describes how you perceive your sexual life is now, compared to how it was before you began taking medication in this study. Responses range from very much better (1) to very much worse (7).|Month 13.5|All randomized participants who received at least 1 dose of study drug and had GAQ Q2 assessed at Month 13.5.||participants|||Number
807801|NCT01026493|Secondary|Phase II: Overall Survival (OS)|Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. This analysis was planned to occur when all patients had been potentially followed for at least 6 months.|Analysis occurs after all patients have been on study for at 6 months. (Patients are followed from randomization to death or study termination whichever occurs first.)|Eligible patients||months||95% Confidence Interval|Median
807802|NCT01026493|Secondary|Phase II: Objective Response (Partial and Complete Response) Rate for Patients With Measurable Disease After Surgery|Response and progression will be evaluated using standard criteria for patients with malignant gliomas (Macdonald 1990). Partial response and complete response are centrally reviewed.|Analysis occurs after all patients have been on study for at 6 months. (Patients are followed from randomization to death or study termination whichever occurs first.)|Eligible patients with at least one cycle of treatment||percentage of participants||95% Confidence Interval|Number
807803|NCT01026493|Primary|Phase II: 6-month Progression-free Survival (PFS) Rate for Patients With Measurable Disease After Surgery|For patients with measureable disease after surgery: Progression defined as ≥ 25% increase in size of enhancing tumor or any new tumor; or neurologically worse, and steroids stable/increased. Bevacizumab (BEV)-naïve group: p0= 15% as estimate of 6-mo. PFS [null hypothesis (NH)], p1= 30%, with a 15% absolute increase [alternative hypothesis (AH)]. Error rates of 10% alpha and 10% beta. If <= 11 patients experience 6-month PFS of the first 53 analyzable patients, then do not reject the null hypothesis that the 6-month PFS rate of experimental arm is less than 15%; BEV-failure group: p0 = 2% as a conservative estimate of 6-month PFS [NH], p1 = 15%, with a 13% absolute increase [AH]. Using first 26 analyzable subjects for each experimental arm, there is >= 90% power to detect >= 15% increase at a significance level of 0.10, using a 1-sided binomial test. If >= 2 patients (8%) are progression free at 6 mo., then claim this regimen to be promising in the patient group.|Randomization to 6 months.|Randomized patients with measurable disease after surgery, at least one cycle of treatment, evaluable for 6 month PFS, and within the required sample size (i.e. the first 53 BEV-naive patients and the first 26 BEV-failure patients- the number of patients will be less than sample size if not enough patients meet the criteria).||participants|||Number
807804|NCT01026493|Primary|Phase 1: Maximum Tolerated Dose (MTD)|Dose limiting toxicity (DLT) = any of the following events within 1st 8 weeks of treatment attributable to study drugs: Any grade (gr) 3/4 thrombocytopenia, gr 4 anemia, gr 3 neutropenia with fever (>100.4). gr 4 neutropenia lasting > 7 days; Any non-hematologic (NH) gr 3+ toxicity (TOX), excluding alopecia, despite maximal medical therapy (MLT); NH TOX such as rash, nausea, vomiting, diarrhea, mucositis, hypophosphatemia, and hypertension will only be considered DLTs if they remain gr 3+ despite MLT; 2nd occurrence of thromboembolism; Failure to recover from TOX (<= gr 1) to be eligible for re-treatment with study drugs <= 14 days of last dose of either drug; Any episode of non-infectious radiologically observed pneumonitis gr 2-4 any duration. Dose level will be considered acceptable if <= 1 of the 1st 6 eligible patients experiences a DLT. If current level is considered acceptable, dose escalation occurs. Otherwise preceding acceptable dose level will be declared the MTD.|Start of treatment to 8 weeks.|Eligible patients who started study treatment||participants|||Number
807805|NCT01026792|Primary|Objective Response Rate|Response is defined as a 30% decrease in the sum of the longest diameters of the target lesions (PR) or complete disappearance of disease and symptoms (CR) for at least 4 weeks as assessed by Response Evaluation Criteria in Solid Tumors 1.1|Up to 3 years|Patients evaluable for response||percentage of patients with response||95% Confidence Interval|Number
807806|NCT01026805|Primary|Percentage of Tissue Removed|mean percentage of polyp and fibroid tissue removed, as measured on post-treatment hysteroscopic imaging. Images were obtained immediately post treatment, before the subject left the surgical suite.|immediately post-treatment|||Percentage of tissue removed||Full Range|Mean
807807|NCT01026805|Secondary|Adverse Events|Patient medical records were examined to identify any procedure-related or post-treatment adverse events. An adverse event is any undesirable experience (sign, symptom, illness, or other medical event) occurring in a subject, that appears or worsens during a clinical study|2-3 months post-treatment|||events|||Number
807808|NCT01026805|Secondary|Interlace Medical 1st Generation Hysteroscopic Morcellator Cutting Ability - Mean Score|a 10 point scale assessed performance of the Interlace Medical 1st Generation Hysteroscopic Morcellator(“1” = “poor” and “10” = “excellent”).|2-3 months post treatment|All treating physicians completed a survey questionnaire.||scores on a scale||Full Range|Mean
807809|NCT01026805|Secondary|Resected Tissue Weight Per Patient|mean weight of resected tissue per patient|at time of treatment|||g||Full Range|Mean
807810|NCT01026805|Secondary|Fluid Deficit Per Procedure|mean fluid deficit per procedure. Fluid deficit is the difference between the amount of fluid which is infused into the patient during the hysteroscopic procedure, and the amount of fluid collected at completion of the procedure.|at time of treatment|||mL||Full Range|Mean
807811|NCT01026805|Secondary|Fluid Volume Per Procedure|mean volume of distension fluid infused into the uterus, per procedure. Distention fluid is used to distend the uterus and provide increased visibility.|at time of treatment|||mL||Full Range|Mean
807812|NCT01026805|Secondary|Treatment Time Per Patient|mean morcellation(division into and removal of small pieces, as of tissue) time per patient|at time of treatment|||minutes||Full Range|Mean
807813|NCT01026818|Secondary|Change in Penile Length and Girth|Measurements were performed with the penis in the flaccid state. The stretched penile length was measured from the tip of the glans to the pubopenile skin junction while applying tension to maximally stretch the penis. The penile circumference at midshaft was measured. All measurements were taken with a paper ruler to the nearest 0.5 centimeter (cm). The analysis of covariance (ANCOVA) was used to calculate Least Square (LS) mean and 95% confidence interval (CI). LS mean values are adjusted for treatment, baseline, age group and country.|Randomization (Baseline), Month 9|All randomized participants who received at least 1 dose of study drug and had penile measurements at Baseline and Month 9.||millimeter (mm)||95% Confidence Interval|Least Squares Mean
807825|NCT01026818|Secondary|Residual Erectile Function (REF) at Baseline|The participant is asked to rate the hardness of his erection using a 5-point grading system, with 0 (penis does not enlarge), 1 (penis is larger but not hard), 2 (penis is hard but not enough for penetration), 3 (penis is hard enough for penetration but not completely hard), 4 (penis is completely hard and fully rigid.)|Baseline|All randomized participants who received at least 1 dose of study drug and had REF assessed at baseline.||participants|||Number
807814|NCT01026818|Secondary|Change From Baseline in 26-item Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Score|EPIC-26 (participants) contains 26 items and 5 domains: Urinary Incontinence (Items 1-4), Urinary Irritative/Obstructive (Items 5-8), Bowel (Items 10-15), Sexual (Items 16-21), and Hormonal (Items 22-26). Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0 to 100 scale for each domain, with higher scores representing better health-related quality of life. Responses are based on experiences during the previous 4 weeks. The Mixed Model for Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% confidence interval (CI). LS mean values are adjusted for baseline domain score, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|Randomization (Baseline), Months 9 and 13.5|All randomized participants who received at least 1 dose of study drug, had baseline and at least 1 post-baseline EPIC-26 scores measurement at Month 9 and Month 13.5.||units on a scale||95% Confidence Interval|Least Squares Mean
807815|NCT01026818|Secondary|Standardized Morning Erections Question (SMEQ) Score at Month 13.5|"Participants evaluated the frequency of their morning erections during the past 3-month period by answering the SMEQ (Do you ever wake up with an erection) using a 4-point grading system ranging from 0 (Yes, regularly) to 3 (never)."|Month 13.5|All randomized participants who received at least 1 dose of study drug and had SMEQ measurement at Month 13.5.||participants|||Number
807816|NCT01026818|Secondary|Standardized Morning Erections Question (SMEQ) Score at Month 9|"Participants evaluated the frequency of their morning erections during the past 3-month period by answering the SMEQ (Do you ever wake up with an erection) using a 4-point grading system ranging from 0 (Yes, regularly) to 3 (never)."|Month 9|All randomized participants who received at least 1 dose of study drug and had SMEQ measurement at Month 9.||participants|||Number
807817|NCT01026818|Secondary|Standardized Morning Erections Question (SMEQ) Score at Month 2|Participants evaluated the frequency of their morning erections during the past 3-month period by answering the SMEQ (“Do you ever wake up with an erection”) using a 4-point grading system ranging from 0 (Yes, regularly) to 3 (never).|Month 2|All randomized participants who received at least 1 dose of study drug and had SMEQ measurement at Month 2||participants|||Number
807818|NCT01026818|Secondary|Change From Baseline in ‘Yes’ Answers to Morning Erections|The participants were asked to complete the morning erections diary every morning during the 4-week period before randomization and during the 6-week, Drug-Free, Washout Period. Data presented are the changes in the participant's percentage of “yes” responses relative to the number of days the question was answered during treatment. The analysis of covariance (ANCOVA) was used to calculate Least Square (LS) mean and 95% confidence interval (CI). LS mean values are adjusted for treatment, baseline morning erections frequency, age group and country.|Randomization (Baseline), Month 10.5|All randomized participants who received at least 1 dose of study drug and had morning erection question answered at Baseline and Month 10.5.||"percentage of yes response"||95% Confidence Interval|Least Squares Mean
807819|NCT01026818|Secondary|Change From Baseline in ‘Yes’ Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)|Participant-assessed diary has 5 questions: Question (Q)1: erection achievement, Q2: successful penetration, Q3: successful intercourse, Q4: satisfied with erection, and Q5: satisfied with sexual experience) for each sexual encounter made over a specified period of time. SEP Q1-Q5 scores were determined as the percentage of 'Yes' responses to each of the 5 questions out of all sexual attempts recorded during the time period. The Mixed Model for Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% confidence interval (CI). LS mean values are adjusted for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|Randomization (Baseline), Months 9 and 10.5 and 13.5|All randomized participants who received at least 1 dose of study drug, had baseline and at least 1 post-baseline SEP questions answered at Months 9, 10.5 and 13.5.||"percentage of yes responses"||95% Confidence Interval|Least Squares Mean
807820|NCT01026818|Secondary|Residual Erectile Function (REF) at Month 13.5|The participant is asked to rate the hardness of his erection using a 5-point grading system, with 0 (penis does not enlarge), 1 (penis is larger but not hard), 2 (penis is hard but not enough for penetration), 3 (penis is hard enough for penetration but not completely hard), 4 (penis is completely hard and fully rigid.)|Month 13.5|All randomized participants who received at least 1 dose of study drug and had REF assessed at Month 13.5.||participants|||Number
807821|NCT01026818|Secondary|Residual Erectile Function (REF) at Month 10.5|The participant is asked to rate the hardness of his erection using a 5-point grading system, with 0 (penis does not enlarge), 1 (penis is larger but not hard), 2 (penis is hard but not enough for penetration), 3 (penis is hard enough for penetration but not completely hard), 4 (penis is completely hard and fully rigid.)|Month 10.5|All randomized participants who received at least 1 dose of study drug and had REF assessed at Month 10.5.||participants|||Number
807822|NCT01026818|Secondary|Residual Erectile Function (REF) at Month 9|The participant is asked to rate the hardness of his erection using a 5-point grading system, with 0 (penis does not enlarge), 1 (penis is larger but not hard), 2 (penis is hard but not enough for penetration), 3 (penis is hard enough for penetration but not completely hard), 4 (penis is completely hard and fully rigid.)|Month 9|All randomized participants who received at least 1 dose of study drug and had REF assessed at Month 9.||participants|||Number
807823|NCT01026818|Secondary|Residual Erectile Function (REF) at Month 5|The participant is asked to rate the hardness of his erection using a 5-point grading system, with 0 (penis does not enlarge), 1 (penis is larger but not hard), 2 (penis is hard but not enough for penetration), 3 (penis is hard enough for penetration but not completely hard), 4 (penis is completely hard and fully rigid.)|Month 5|All randomized participants who received at least 1 dose of study drug and had REF assessed at Month 5.||participants|||Number
807824|NCT01026818|Secondary|Residual Erectile Function (REF) at Month 2|The participant is asked to rate the hardness of his erection using a 5-point grading system, with 0 (penis does not enlarge), 1 (penis is larger but not hard), 2 (penis is hard but not enough for penetration), 3 (penis is hard enough for penetration but not completely hard), 4 (penis is completely hard and fully rigid.)|Month 2|All randomized participants who received at least 1 dose of study drug and had REF assessed at Month 2.||participants|||Number
807894|NCT01027286|Primary|Number of Patients Managed With Blood Transfusion||daily during hospital stay (an expected average of 4 days)|||participants|||Number
807895|NCT01027286|Secondary|Total Calculated Hospital Blood Loss||daily during hospital stay (an expected average of 4 days)|||mL||Standard Deviation|Mean
807827|NCT01026818|Secondary|Global Assessment Question (GAQ) Question 2 at Month 9|GAQ Question 2: Choose the one number which best describes how you perceive your sexual life is now, compared to how it was before you began taking medication in this study. Responses range from very much better (1) to very much worse (7).|Month 9|All randomized participants who received at least 1 dose of study drug and had GAQ Q2 assessed at Month 9.||participants|||Number
807828|NCT01026818|Secondary|Global Assessment Question (GAQ) Question 1 at Month 13.5|GAQ Question 1: Choose the one number which best describes how you perceive your ability to achieve and maintain your erections now, compared to how it was before you began taking medication in this study. Responses range from very much better (1) to very much worse (7).|Month 13.5|All randomized participants who received at least 1 dose of study drug and had GAQ Q1 assessed at Month 13.5.||participants|||Number
807829|NCT01026818|Secondary|Global Assessment Questions (GAQ) Question 1 at Month 9|GAQ Question 1: Choose the one number which best describes how you perceive your ability to achieve and maintain your erections now, compared to how it was before you began taking medication in this study. Responses range from very much better (1) to very much worse (7).|Month 9|All randomized participants who received at least 1 dose of study drug and had GAQ Q1 assessed at Month 9.||participants|||Number
807830|NCT01026818|Secondary|Change From Baseline in Self Esteem and Relationship (SEAR) Questionnaire Score|The SEAR questionnaire is a participant-reported measure of psychosocial outcomes in men with erectile dysfunction (ED). It consists of 14 items. Sexual Relationship domain consists of 8 items (items 1-8). Items 2-8 are rated on a scale of 1 (Never) to 5 (Always), whereas item 1 is reverse scored (1=Always and 5=Never). The total scores for sexual relationship domain range from 8-40 with higher scores indicating better relationship. Self-Esteem subdomain contains items 9 through 12 rated on a scale of 1 (no/low self-esteem) to 5 (high self-esteem). Total scores for Self-Esteem subscale range from 4-20 with higher scores indicating higher self-esteem. The Mixed Model for Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% Confidence Interval (CI). LS mean values are adjusted for baseline domain score, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|Randomization (Baseline), Months 9 and 13.5|All randomized participants who received at least 1 dose of study drug, had baseline and at least 1 post-baseline SEAR scores measurement at Months 9 and 13.5.||units on a scale||95% Confidence Interval|Least Squares Mean
807831|NCT01026818|Secondary|Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire Mean Score|The EDITS questionnaire is a validated questionnaire consisting of 11 questions evaluating self-reported satisfaction with the erectile dysfunction (ED) treatment. Responses were based on the experiences during the previous 4 weeks. Each question is rated on a scale of 0 (extremely low treatment satisfaction) to 4 (extremely high treatment satisfaction). The EDITS mean score was obtained by adding each individual result for all questions, dividing by the number of questions answered. The mean scores range from 0 (extremely low treatment satisfaction) to 4 (extremely high satisfaction). The Mixed Model for Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% Confidence Interval (CI). LS mean values are adjusted for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|Months 9 and 13.5|All randomized participants who received at least 1 dose of study drug and had EDITS mean scores measurements at Months 9 and 13.5.||units on a scale||95% Confidence Interval|Least Squares Mean
807832|NCT01026818|Secondary|Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF) Domains (Intercourse Satisfaction Domain, Orgasmic Function Domain, Sexual Desire Domain, Overall Satisfaction Domain)|Self-reported overall satisfaction during past 4 weeks. Orgasmic function score is sum of Questions (Q)9 and 10 of IIEF. Scores range from 0 (no sexual stimulation or intercourse) to 5 (high orgasm) for each Q, total 0 to 10. Sexual desire score is sum of Q11 and 12 of IIEF. Scores range from 1 (low/no desire) to 5 (high desire) for each Q, total 2 to 10. Intercourse satisfaction score is sum of Q6, 7 and 8 of IIEF. Scores range from 0 (no attempts for Q6, did not attempt intercourse for Q7 and no intercourse for Q8) to 5 (high satisfaction) for each Q, total 0 to 15. Overall satisfaction score is sum of Q13 and 14 of IIEF. Scores range from 1 (low/no satisfaction) to 5 (high satisfaction) for each Q, total 2 to 10. Higher total scores for each domain indicate higher function. MMRM analysis was used to calculate LS mean and 95% CI. LS mean values are adjusted for baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|Randomization (Baseline), Months 9 and 10.5 and 13.5|All randomized participants who received at least 1 dose of study drug, had baseline and at least one post-baseline IIEF domain scores measurements at Months 9, 10.5 and 13.5.||units on a scale||95% Confidence Interval|Least Squares Mean
807833|NCT01026818|Secondary|Change From Baseline to Endpoint in the International Index of Erectile Function- Erectile Function (IIEF-EF) Total Score|Self-reported erectile function during the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. The Mixed Model for Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% confidence interval (CI). LS mean values are adjusted for baseline score, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|Randomization (Baseline), Months 9 and 10.5 and 13.5|All randomized participants who received at least 1 dose of study drug, had baseline and at least one post-baseline IIEF-EF Total Scores measurement at Months 9, 10.5 and 13.5.||units on a scale||95% Confidence Interval|Least Squares Mean
807834|NCT01026818|Secondary|Percentage of Participants With a Score of Greater Than or Equal to 22 in the International Index of Erectile Function- Erectile Function (IIEF-EF) Domain|Self-reported erectile function during the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Data presented are the percentage of participants with an IIEF-EF Total Score greater than or equal to (≥) 22.|Month 9 and Month 13.5|All randomized participants who received at least 1 dose of study drug and had IIEF-EF Total Scores measurements at Months 9 and 13.5.||percentage of participants|||Number
807835|NCT01026818|Primary|Percentage of Participants With a Score of Greater Than or Equal to 22 in the Erectile Function (EF) Domain of the International Index of Erectile Function (IIEF) Questionnaire|Self-reported erectile function during the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Data presented are the percentage of participants with an IIEF-EF Total Score greater than or equal to (≥) 22.|Month 10.5|All randomized participants who received at least 1 dose of study drug and had IIEF-EF Total Scores measurement at Month 10.5.||percentage of participants|||Number
807836|NCT01026831|Other Pre-specified|Baseline IOP|IOP was measured using a Goldmann applanation tonometer. The primary evaluation was based on the study eye (the worse eye based on the 0800 hour IOP baseline or the right eye when both eyes had the same IOP).|Baseline|The Per-Protocol (PP) approach excluded all patients with important protocol violations and was performed for the efficacy endpoints. The PP population excluded patients due to important deviations from the protocol that may have substantially affected the results of the primary endpoints.||mmHg||95% Confidence Interval|Least Squares Mean
807837|NCT01026831|Primary|Mean Intraocular Pressure (IOP) Change From Baseline at All 9 Time Points During the Study (0800, 1000 and 1600 Hrs at Weeks 2, 6, and 12)|"IOP was measured using a Goldmann applanation tonometer. The primary evaluation was based on the study eye (the worse eye based on the 0800 hour IOP baseline or the right eye when both eyes had the same IOP).
IOP change from baseline was calculated using the baseline IOP at each time point (0800 hours at baseline to 0800 hours at Week 2, 6, and 12; 1000 hours at baseline to 1000 hours at Week 2, 6, and 12; 1600 hours at baseline to 1600 hours at Week 2, 6, and 12).
Lowering elevated IOP is a treatment goal of glaucoma."|Baseline, Weeks 2, 6, and 12.|The Per-Protocol (PP) approach excluded all patients with important protocol violations and was performed for the efficacy endpoints. The PP population excluded patients due to important deviations from the protocol that may have substantially affected the results of the primary endpoints.||mmHg||95% Confidence Interval|Least Squares Mean
807838|NCT01026844|Secondary|Correlate Epidermal Growth Factor Receptor (EGFR) Mutations and EGFR Amplification With Response to Treatment in Patients With Available Tumor Specimens.||2 years|Because so few responses were observed, this exploratory outcome was not analyzed|||||
807839|NCT01026844|Secondary|Objective Tumor Response Rate|Number of Response Evaluation Criteria in Solid Tumors (RECIST) responses divided by number of patients treated. Per RECIST version 1.0 complete response (CR) is defined as disappearance of all target lesions; Partial Response (PR) is defined as >=30% decrease in the sum of the longest diameter of target lesions. The objective tumor response rate is the CR + PR divided by the total number of patients|2 years|||percentage of patients||95% Confidence Interval|Number
807840|NCT01026844|Secondary|Determine the Pharmacokinetic (PK) Parameters of Hydroxychloroquine (HCQ) Plus Erlotinib.|PK parameter tested was dose normalized minimum steady state concentration (Cmin SS) of HCQ in micromolar per gram. Note this outcome was only analyzed for the first 21 patients enrolled, 13 on erlotinib/HCQ and 8 on HCQ arm.|2 years|The patients participating in the randomized portion of the study were analyzed for PK parameters. When the HCQ alone arm of the study was closed, PK measurements were no longer performed||micromolar per gram||Standard Deviation|Mean
807841|NCT01026844|Primary|Describe the Number and Type of Observed Dose Limiting Toxcities|HCQ doses tested included 400mg, 600mg, 800mg, and 1000mg. Dose-limiting toxicities (DLTs) were defined as CTC of grade 2 or higher retinopathy or keratitis, or CTC of grade 3 or higher hematologic, skin, CNS, neuropathic, cardiac, respiratory, gastrointestinal, or renal AEs in the first cycle considered at least possibly related to HCQ. If a DLT was observed, an additional three patients were enrolled at that dose level. The maximum tolerated dose for HCQ in each arm would be defined as one dose level below that at which two or more of 6 patients experienced a DLT, or if no DLTs were observed, the highest tested dose.|2 years|In October 2008, after enrollment of 18 patients (8 on arm A and 10 on arm B), the study was amended to limit enrollment to arm B only (HCQ plus erlotinib) given the increasing preclinical evidence supporting a role for combination therapy (but not HCQ monotherapy) and to help increase overall patient accrual.||participants|||Number
807842|NCT01026909|Secondary|Second Outcome Variable: Ambulatory Activity. It Will be Defined as Average Steps/Day as Measured by the StepWatch Activity Monitor for a 7 Day Sample.||StepWatch monitor will be used 7 days prior to treatment and 4 weeks, 4 months and 12 months follow up visits|||steps/day||Standard Deviation|Mean
807843|NCT01026909|Primary|Primary Outcome Variable: Function. The Pediatric Outcomes Data Collection Instrument (PODCI) Will be the Primary Endpoint as a Measure of Function and Health Related Quality of Life at 12 Months Post Injection.|"The Pediatric Outcomes Data Collection Instrument (PODCI) is designed to be completed by the parent/guardian of a child ten years of age or younger who has knowledge of the child's conditions. The eight scales generated from these instruments are:
Upper Extremity and Physical Function Scale; Transfer and Basic Mobility Scale; Sports/Physical Functioning Scale; Pain/Comfort; Treatment Expectations Scale; Happiness Scale; Satisfaction with Symptoms Scale and Global Functioning Scale. The results of each scale are standardized into a scale of 0-100 where 0 indicates the worst outcome and 100 the best.
We decided to report Global Functioning only due to space limitations. Also the Global Functioning scale encompasses items from other scales."|This exam is to be administered at time of enrollment and at 4 and 12 months follow up visits.|||units on a scale||Standard Deviation|Mean
807844|NCT01026948|Secondary|Number of Participants Who Were Satisfied With Monitoring at Home|Maternal views were assessed by semi-structured diaries,recording women’s ratings on a 4 point scale (very satisfied, satisfied, slightly disatisfied, very disatisfied)of how well they were coping and their satisfaction with outpatient experience.Women completed diaries at least once every two hours at home.Mean scores were calculated for women’s ratings of coping, comfort satisfaction and location preference. An interpretive approach was utilised for all open responses. Comments made in the free-text spaces of diaries were categorised to contextualise women’s ratings of their experience|6 months|51 women out 70 returned the semistructured diaries. All the diaries were assessed as explained above.||participants|||Number
808059|NCT01019694|Secondary|Physician's Global Evaluation at Week 48|"Physicians evaluated the patient's overall clinical condition on a scale ranging from poor (score 1 or 2) to excellent (score 7 or 8)."|48 weeks|Treated Set is defined as all patients who were randomized and received study drug||unit on a scale||Standard Error|Least Squares Mean
807845|NCT01026948|Primary|Feasibility Defined as the Number of Eligible Women Who Are Successfully Monitored Remotely With Trans-abdominal Fetal Electrocardiogram (ECG) Monitoring Device (Monica AN24) While Undergoing Labour Induction.|Outpatient induction is when women recieve medication to induce labour at the hospital, but can then go home for monitoring until labour progresses. When 'standard' Doppler Ultrasound FHR technology is used, women may feel restrained as the Doppler-FHR machine (which is bench-top device) is connected to the transducer which is then mounted on the woman's abdomen and attached by an elastic belt, which is known to be uncomfortable for pregnant woman. The AN 24 device is portable and attaches to the patients abdomen allowing remote fetal monitoring whilst the women are at home.|6 months|70 women were recruited to the study, but 8 women were called back to the unit because of signal loss.||participants|||Number
807846|NCT01026974|Secondary|Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine One Month Apart, Either at 40 or 60 Months of Age|The safety and tolerability of a two doses of rMenB+OMV NZ vaccine in children when given either at 40 & 42 months or 60 & 62 months of age is assessed in terms of number of subjects with solicited local and systemic reactions following vaccination.|Day 1-7 after each vaccination|Analysis was done on the Safety population||participants|||Number
807847|NCT01026974|Secondary|Percentage of Subjects With 4-fold Increase in Geometric Mean Antibody Concentrations, After Two Catch-up Doses of rMenB+OMV NZ Vaccine Given One Month Apart Either at 40 or 60 Months of Age|The percentages of subjects with four-fold increase in GMCs over baseline against vaccine antigen 287-953, one month after receiving a two catch-up doses of rMenB+OMV NZ vaccine either at 40 & 42 months or 60 & 62 months of age.|1 month post dose 2|Analysis was done on MITT population||percentages of subjects||95% Confidence Interval|Geometric Mean
807848|NCT01026974|Secondary|Percentage of Subjects With Four Fold Increase in Geometric Mean Antibody Concentrations , After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age|The percentage of subjects with four fold increase in GMCs over baseline against vaccine antigen 287-953 one month after receiving a single booster dose of either rMenB or rMen+OMV NZ vaccine, is compared with responses following one catch–up dose of rMenB+OMV NZ in children at 40 months.|1 month post booster / 1 month post dose 1|Analysis was done on MITT population||percentages of subjects||95% Confidence Interval|Number
807849|NCT01026974|Secondary|Geometric Mean Antibody Concentrations in Children (at 60 Months), Eighteen Months After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine.|Persistence of GMCs against vaccine antigen 287-953 in children (60 months of age), eighteen months after two catch-up doses of rMenB+OMV NZ vaccine given at 40 months of age.|18 months post vaccine dose 2|Analysis was done on MITT population||concentrations (AU/mL)||95% Confidence Interval|Geometric Mean
807850|NCT01026974|Secondary|Geometric Mean Antibody Concentrations in Children After Two Doses of rMenB+OMV NZ Vaccine Given One Month Apart, Either at 40 Months or 60 Months of Age.|The GMCs against vaccine antigen 287-953 in children after two catch-up doses of rMenB+OMV NZ vaccine when given either at 40- & 42- months or 60- & 62- months of age are reported.|1 month post vaccine dose two|Analysis was done on the MITT population.||concentrations (AU/mL)||95% Confidence Interval|Geometric Mean
807851|NCT01026974|Secondary|Geometric Mean Antibody Concentrations in Children (at 60 Months of Age), Twenty Months After Receiving a Booster Dose of rMenB or rMenB+OMV NZ Vaccine|The persisting GMCs against vaccine antigen 287-953 in children (at 60 months of age), twenty months after receiving a booster dose of either rMenB or rMenB+OMV NZ vaccine (at 40 months), are compared with GMCs in vaccine-naïve children of same age.|20 months post booster/ Baseline for Naïve|Analysis was done on MITT population.||concentrations (AU/mL)||95% Confidence Interval|Geometric Mean
807852|NCT01026974|Secondary|Geometric Mean Antibody Concentrations in Children, After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age.|The GMCs against vaccine antigen 287-953, in children one month after receiving a single booster dose of either rMenB or rMen+OMV NZ vaccine , is compared with GMCs following one catch–up dose of rMenB+ OMV NZ in children at 40 months.|1 month post booster /1 month post dose 1 for Naïve|Analysis was done on MITT population||concentrations (AU/mL)||95% Confidence Interval|Geometric Mean
807853|NCT01026974|Secondary|Geometric Mean Antibody Concentrations in Children (at 40 Months of Age), Twenty Eight Months After Completing Primary Vaccination.|"The persisting geometric mean antibody concentrations (GMCs) against vaccine antigen 287-953 in children (at 40 months of age), twenty-eight months after completion of primary vaccination with either rMenB or rMen+OMV NZ vaccines, are compared with the GMCs in vaccine-naïve children.
GMCs against vaccine antigen 287-953 were measured using enzyme linked immunosorbent assay (ELISA)."|28 months after primary vaccination/ Baseline for Naïve|Analysis was done on MITT population.||concentrations (AU/mL)||95% Confidence Interval|Geometric Mean
807854|NCT01026974|Secondary|Percentage of Subjects With Serum Bactericidal Antibody Titers ≥4, Eighteen Months After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine.|Persisting hSBA titers ≥4 in children at 60 months of age, who had received two catch-up doses of rMenB+OMV NZ vaccine at 40 & 42 months age is reported.|18 months post vaccine dose two|Analysis was done on MITT population||percentages of subjects||95% Confidence Interval|Number
807855|NCT01026974|Secondary|Persistence of Serum Bactericidal Antibody Titers in Children (at 60 Months), Eighteen Months After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine.|The serum bactericidal antibody response in children at 60 months of age who had received two catch-up doses of rMenB+OMV NZ vaccine at- 40 & 42 months age is reported as GMTs.|18 months post vaccine dose 2|Analysis was done on the MITT population||Titers||95% Confidence Interval|Geometric Mean
807856|NCT01026974|Secondary|Percentage of Subjects With a 4-fold Increase in Antibody Titers After Two Catch up Doses of rMenB+OMV NZ Vaccine Given One Month Apart Either at 40 or 60 Months of Age|The percentages of subjects with four-fold increase in hSBA titers over baseline against N meningitidis serogroup B one month after receiving a two catch-up doses of rMenB+OMV NZ vaccine either at 40 & 42 months or 60 & 62 months of age.|1 month post vaccine dose 2|Analysis was done on MITT population||percentages of subjects||95% Confidence Interval|Number
807857|NCT01026974|Secondary|Serum Bactericidal Antibody Titers in Children Following Two Doses of rMenB+OMV NZ Vaccine Given One Month Apart, Either at 40 or 60 Months of Age.|The serum bactericidal antibody response in children after two catch-up doses of rMenB+OMV NZ vaccine when given either at- 40 & 42 months or 60 & 62 months of age are reported as GMTs.|1 month post vaccine dose two|Analysis was done on MITT population||Titers||95% Confidence Interval|Geometric Mean
807858|NCT01026974|Secondary|Percentage of Subjects With Serum Bactericidal Antibody Titers ≥4 Following Two Doses of rMenB+OMV NZ Vaccine Given One Month Apart, Either at 40 or 60 Months of Age|The percentage of subjects with hSBA titers ≥4 after two catch-up doses of rMenB+OMV NZ vaccine when given either at- 40 & 42 months or 60 & 62 months of age is reported.|1 month post -vaccine dose two|Analysis was done on MITT population||percentages||95% Confidence Interval|Number
807859|NCT01026974|Secondary|Percentage of Subjects With Persisting Serum Bactericidal Antibody Titers ≥4, Twenty Months After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine|The percentage of subjects (60 months of age) with persisting hSBA titers ≥4, twenty months after receiving a booster dose of either rMenB or rMenB+OMV NZ vaccine (at 40 months of age) are compared with hSBA response in vaccine-naïve subjects of the same age.|20 months post booster/ Baseline for Naïve|This analysis was done on MITT population||percentages of subjects||95% Confidence Interval|Number
807860|NCT01026974|Secondary|Persistence of Serum Bactericidal Antibody Titers in Children (at 60 Months of Age), Twenty Months After Receiving a Booster Dose of rMenB or rMenB+OMV NZ Vaccine|The persisting serum bactericidal antibody titers in children (at 60 months of age), twenty months after receiving a booster dose of either rMenB or rMenB+OMV NZ vaccine (at 40 months of age) is compared with the antibody titers in vaccine –naïve subjects of the same age and reported as GMTs.|20 months post booster/ Baseline for Naïve|Analysis was done on the MITT population||Titers||95% Confidence Interval|Geometric Mean
807861|NCT01026974|Secondary|Percentage of Subjects With a 4-fold Increase in Antibody Titers After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age|"The percentages of subjects with four-fold increase in hSBA titers over baseline against N meningitidis serogroup B, one month after receiving a single booster dose of rMenB or rMenB+OMV NZ vaccine at 40 months of age, and compared with 4-fold increase in hSBA titers following one catch-up dose of rMenB+OMV NZ vaccine given at 40 months to vaccine-naive subjects.
Baseline was defined as either the time that the (first) booster dose was given (i.e. at 40 months of age) or the time of the first vaccination (i.e. at 40 months of age for Naive_4042 group."|1 month post booster / 1 month post dose 1 for Naïve|Analysis was done on MITT population||percentages of subjects||95% Confidence Interval|Number
807862|NCT01026974|Secondary|Percentage of Subjects With Serum Bactericidal Antibody Titers ≥4 After Receiving a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine at 40 Months of Age|The percentages of subjects with hSBA titers ≥4 against N meningitidis serogroup B one month after receiving a single booster dose of rMenB or rMenB+OMV NZ vaccine at 40 months of age, is compared with hSBA response following one catch-up dose of rMenB+OMV NZ vaccine given at 40 months in vaccine-naive subjects.|1 month post-booster/ 1 month post-dose 1 for Naïve|Analysis was done on MITT population.||percentages of subjects||95% Confidence Interval|Number
807863|NCT01026974|Primary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age.|The safety and tolerability of a single booster dose of rMenB or rMenB+OMV NZ vaccine in 40 month old children who had previously received three primary doses of the same vaccine as infants in parent study was assessed in terms of number of subjects with solicited local and systemic reactions following vaccination and compared to tolerability in vaccine-naive children who received 1st catch-up dose of rMenB+OMV NZ at 40 months of age.|Day 1 to Day 7 [after booster vaccination /post dose 1 for naive]|Analysis was done on the Safety population- defined as all subjects who received at least one Men B vaccination and provided post-baseline safety data.||participants|||Number
807864|NCT01026974|Primary|Percentage of Subjects With Persisting Serum Bactericidal Antibodies Titers ≥4, Twenty-eight Months After Completing Primary Vaccination.|"The percentages of subjects with persisting serum bactericidal antibodies (hSBA) titers ≥4, against N meningitidis serogroup B at 40 months of age; twenty-eight months after completion of primary vaccination with either rMenB or rMenB+OMV NZ as compared to the vaccine-naïve children are reported.
The serum bactericidal antibodies directed against serogroup B meningococci, are measured by human complement Serum Bactericidal Assay (hSBA)."|28 months after primary vaccination; Baseline for Naïve|Analysis was done on MITT population||percentages of subjects||95% Confidence Interval|Number
807865|NCT01026974|Secondary|Serum Bactericidal Antibody Titers in Children After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age|The serum bactericidal antibody response one month after a booster dose of rMenB or rMenB+OMV NZ vaccine was given to children at 40 months of age is compared with the antibody titers following one catch-up dose rMenB+OMV NZ vaccine given at 40 months to vaccine-naive subjects and reported as GMTs.|1 month post booster /1 month post dose 1 for Naïve|Analysis was done on MITT population.||Titers||95% Confidence Interval|Geometric Mean
807866|NCT01026974|Primary|Persistence of Serum Bactericidal Antibody Titers in Children (at 40 Months of Age), Twenty-eight Months After Completing Primary Vaccination.|The geometric mean antibody titers (GMTs) against Neisseria meningitidis serogroup B in children (at 40 months of age); twenty-eight months after completion of primary vaccination with either rMenB or rMenB+OMV NZ vaccines, are compared with the GMTs in vaccine-naïve children.|28 months after primary vaccination; Baseline for Naïve|Modified Intention-to-treat (MITT) population was defined as enrolled subjects who actually received at least one vaccine dose,and provided at least one evaluable serum sample both before and after baseline.||Titers||95% Confidence Interval|Geometric Mean
807867|NCT01027000|Secondary|Chimerism for CD3||5 years post-registration||||||
807868|NCT01027000|Secondary|Overall Survival||5 years post-registration||||||
807869|NCT01027000|Secondary|Treatment-related Mortality||6 months post-transplant||||||
807870|NCT01027000|Secondary|Chronic GVHD||5 years post-registration||||||
807871|NCT01027000|Secondary|Acute Graft-vs-host Disease (GVHD)||5 years post-registration||||||
807872|NCT01027000|Secondary|Response||5 years post-registration||||||
807896|NCT01027351|Secondary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine Either at 40 Months or 60 Months of Age.|The safety and tolerability of two catch-up doses of rMenB+OMV NZ vaccine when administered either at 40 & 42 months or 60 & 62 months of age in children is assessed in terms of number of subjects with solicited local and systemic reactions following vaccination.|Day 1-7 after any vaccination|Analysis was done on the MITT – Two Dose Catch Up Schedule population.||Number of subjects|||Number
820576|NCT01145898|Primary|6-month Change in Ocular Perfusion Pressures (OPP)|Measurement of change in ocular perfusion pressure, the pressure of blood flow to the eye minus the pressure of within the eye.|Baseline and 6 month visits|||mm Hg||Standard Error|Mean
807873|NCT01027000|Primary|2-year Progression-free Survival in Early Disease Participants|"Percentage of participants who were alive and progression free at 2 years for participants with early disease stage. The 2 year progression free survival, with 95% confidence interval, was estimated using the Kaplan Meier method.
A progression is defined as one of the following events:
>= 50% increase in the products of at least two lymph nodes on two consecutive determinations two weeks apart (at least one lymph node must be >= 2 cm); appearance of new palpable lymph nodes.
>= 50% increase in the size of the liver and/or spleen as determined by measurement below the respective costal margin; appearance of palpable hepatomegaly or splenomegaly, which was not previously present.
> 50% increase in peripheral blood lymphocytes with an absolute increase > 5000/μL.
Transformation to a more aggressive histology (i.e., Richter’s syndrome or prolymphocytic leukemia with >= 56% prolymphocytes)."|2 years post-registration|Participants with early disease stage were analyzed. Two participants, who did not start protocol therapy, were excluded from this analysis.||percentage of participants||95% Confidence Interval|Median
807874|NCT01027195|Secondary|Pain Score Scale|"A single scoring system used to evaluate overall pain on a scale of integers 0 to 10, with 0 representing no pain and 10 representing unbearable pain. Thus, in this context, lower values represent better outcomes."|within 30 days before surgery (preop), 4 weeks after surgery, 12 weeks after surgery|||points on a scale||Standard Deviation|Mean
807875|NCT01027195|Secondary|Harris Hip Score (Outcome Score)|A scoring system used to evaluate the outcome after total hip replacement. Domains include pain (44 points), function (47 points), deformity (4 points), and range of motion (5 points). A total score is computed by summing the individual domain scores, with a maximum of 100 points. Higher values represent better outcomes. A total Harris Hip Score below 70 points is generally considered a poor result, 70 to 80 fair, 80 to 90 good, and 90 to 100 excellent.|within 30 days before surgery (preop), 4 weeks after surgery, 12 weeks after surgery|||points on a scale||Standard Deviation|Mean
807876|NCT01027195|Secondary|Length of Stay||day of hospital discharge|||days||Standard Deviation|Mean
807877|NCT01027195|Secondary|Total Narcotic Usage (Morphine-equivalent mg) During Hospital Stay|Sum of daily morphine-equivalent mg narcotic usage during hospital stay.|daily during hospital stay (an expected average of 4 days)|||total morphine-equivalent mg||Standard Deviation|Mean
807878|NCT01027195|Secondary|Change in Hemoglobin Level|Change in hemoglobin level from baseline to the day of hospital discharge.|within 30 days before surgery (preop), day of hospital discharge|||g/dL||Standard Deviation|Mean
807879|NCT01027195|Secondary|Estimated Blood Loss||Intraoperative (day of surgery)|||mL||Standard Deviation|Mean
807880|NCT01027195|Primary|Number of Patients Managed With Blood Transfusion||daily during hospital stay (an expected average of 4 days)|||participants|||Number
807881|NCT01027195|Secondary|Number of Units Transfused||daily during hospital stay (an expected average of 4 days)|||units of blood||Standard Deviation|Mean
807882|NCT01027273|Secondary|Access to Medical Care|Number of participants who have a primary care doctor|6 months post enrollment into trial|1 missing response from Usual Care group||participants|||Number
807883|NCT01027273|Secondary|Emotional Health|Number of participants diagnosed as depressed utilizing depression scale. Participant is determined to be depressed if Patient Health Questionnaire (PHQ8) ≥ 10. Scale has a total score between 0 and 24 points. A total score of 0 to 4 represents no significant depressive symptoms. A total score of 5 to 9 represents mild depressive symptoms; 10 to 14, moderate; 15 to 19, moderately severe; and 20 to 24, severe.|6 months post enrollment into trial|||participants|||Number
807884|NCT01027273|Secondary|Medication Adherence|"Number of participants adherent to medications as determined with Morisky score ≥ 6 Adherence to medications was measured using the 8-item Morisky Medication Adherence Questionnaire (Morisky). The questionnaire has been validated against an objective measure of adherence and has been used in racially diverse and elderly patient samples. Scores on the questionnaire can be used to classify patients into low and high adherence groups.
Consistent with standard cut points, participants who scored less than 6 points on the Morisky were categorized as nonadherent to medications and participants who scored 6 to 8 points were categorized as adherent."|6 months post enrollment into trial|||participants|||Number
807885|NCT01027273|Secondary|Knowledge and Attitudes About Stroke Recurrence Risk||6 months post enrollment into trial||||||
807886|NCT01027273|Primary|Use of Anti-thrombotic Medication|Number of participants taking anti-thrombotic medication|6 months post enrollment into trial|||participants|||Number
807887|NCT01027273|Primary|LDL Cholesterol|Percentage of participants with controlled Low Density Lipoprotein low (LDL) of less than 100 mg/dL|6 months post enrollment into trial|||percentage of participants|||Number
807888|NCT01027273|Primary|Blood Pressure|Percentage of Participants with Blood Pressure controlled at <140/90 mm Hg|6 months post enrollment into trial|||percentage of participants|||Number
807889|NCT01027286|Secondary|Knee Injury and Osteoarthritis Outcome Score (KOOS)|A scoring system used to evaluate the patient's opinion about his/her knee and associated problems. Subscales include 1) pain, 2) other symptoms, 3) function in daily living (ADL), 4) function in sport and recreation (Sport/Rec), and 5) knee related quality of life (QOL). Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score between 0 to 100 is calculated for each subscale. Subscale scores are generally not combined; rather, they are reported separated. Higher values represent better outcomes (i.e., less extreme symptoms).|within 30 days before surgery (preop), 4 weeks after surgery, 12 weeks after surgery|Vitagel (n=49 at preoperative, 4 wk, 12 wk); Control (n=50 at preoperative, 4 wk; n=49 at 12 wk since one control subject was lost to follow-up)||points on a scale||Standard Deviation|Mean
807890|NCT01027286|Secondary|Pain Score Scale|"A single scoring system used to evaluate overall pain on a scale of integers 0 to 10, with 0 representing no pain and 10 representing unbearable pain. Thus, in this context, lower values represent better outcomes."|within 30 days before surgery (preop), 4 weeks after surgery, 12 weeks after surgery|Vitagel (n=49 at preoperative, 4 wk, 12 wk); Control (n=50 at preoperative, 4 wk; n=49 at 12 wk since one control subject was lost to follow-up)||points on a scale||Standard Deviation|Mean
807891|NCT01027286|Secondary|Length of Stay||day of hospital discharge|||days||Standard Deviation|Mean
807892|NCT01027286|Secondary|Daily Narcotic Usage (Morphine-equivalent mg)||daily during hospital stay (an expected average of 4 days)|||morphine-equivalent mg||Standard Deviation|Mean
807893|NCT01027286|Secondary|Preoperative & Postoperative Hemoglobin Values||within 30 days before surgery (preop), daily during hospital stay (an expected average of 4 days)|||g/dL||Standard Deviation|Mean
807897|NCT01027351|Secondary|Persisting Geometric Mean Concentrations Against Vaccine Antigen 287-953 in Children at 60 Months of Age.|The persisting GMCs against vaccine antigen 287-953 in children at 60 months of age who had either received one or two booster doses of either rMenB or rMenB+OMV NZ vaccine or had received two catch-up doses of rMenB+OMV NZ vaccine at 40 months of age in the present are compared with GMCs in vaccine-naïve subjects.|18-20 months after last Men B vaccine; baseline for naïve_6062|The analysis was done on the MITT, 60 months of age, antibody persistence population population.||AU/mL||95% Confidence Interval|Geometric Mean
807898|NCT01027351|Secondary|Geometric Mean Concentrations Against Vaccine Antigen 287-953 in Children After Two Catch up Doses of rMenB+OMV NZ Vaccine Given Either at 40 or 60 Months of Age.|The GMCs against vaccine antigen 287-953 in children after two catch-up doses of rMenB+OMV NZ vaccine when given either at - 40 & 42 months or 60 & 62 months of age are reported.|1 month post vaccine dose two|The analysis was done on the MITT population, Booster response.||AU/mL||95% Confidence Interval|Geometric Mean
807899|NCT01027351|Secondary|Geometric Mean Antibody Concentrations Against Vaccine Antigen 287-953 in Children After Receiving Two Booster Doses of Either rMenB or rMenB+OMV NZ at 40 & 42 Months of Age.|The GMCs against vaccine antigen 287-953 in children (who had previously received 1 dose of either rMenB or rMen+OMV NZ vaccines in parent study) , are compared with the GMCs in children who received to catch-up doses of rMenB+OMV NZ at 40 & 42 months .|1 month after each booster/ vaccine dose|The analysis was done on the MITT population, booster response.||AU/mL||95% Confidence Interval|Geometric Mean
807900|NCT01027351|Secondary|Geometric Mean Antibody Concentrations Against Vaccine Antigen 287-953 in Children (Who Had Previously Received 4 Doses of MenB Vaccine) After Receiving One Booster Dose of Either rMenB or rMenB+OMV NZ at 40 Months of Age.|The GMCs against vaccine antigen 287-953 in children (who had previously received four doses MenB vaccine in parent study) after a single booster dose of either rMenB or rMenB+OMV NZ vaccine given at 40 months of age, are compared with the GMCs following one catch-up dose rMenB+OMV NZ vaccine given at 40 months to vaccine-naive subjects.|1 month post booster; 1 month post dose for naïve_4042 group|The analysis was done on the MITT, 40 months of age, antibody persistence population.||AU/mL||95% Confidence Interval|Geometric Mean
807901|NCT01027351|Secondary|Persisting Geometric Mean Antibody Concentrations Against Vaccine Antigen 287-953 in Children (Who Had Previously Received 1dose of MenB Vaccine in Parent Study) at 40 Months of Age.|"The persisting GMCs against vaccine antigen 287-953 in children (at 40 months of age) who had previously received 1 dose of either rMenB or rMen+OMV NZ vaccines in parent study , are compared with the the GMCs in vaccine-naïve children.
GMCs against vaccine antigen 287-953 were measure using ELISA."|28 months after last Men B vaccination; baseline for naïve_4042 group|The analysis was done on the MITT, 40 months of age, antibody persistence population.||AU/mL||95% Confidence Interval|Geometric Mean
807902|NCT01027351|Secondary|Persisting Geometric Mean Antibody Concentrations Against Vaccine Antigen 287-953 in Children (Who Had Previously Received 4 Doses of MenB Vaccine in Parent Study) at 40 Months of Age.|"The persisting geometric mean antibody concentrations (GMCs) against vaccine antigen 287-953 in children (at 40 months of age) who had previously received 4 doses of either rMenB or rMen+OMV NZ vaccines in parent study , are compared with the the GMCs in vaccine-naïve children.
GMCs against vaccine antigen 287-953 were measured using enzyme linked immunosorbent assay (ELISA)."|28 months after last Men B vaccination; Baseline for Naïve_4042 group|The analysis was done on the MITT, 40 months of age, antibody persistence population.||AU/mL||95% Confidence Interval|Geometric Mean
807903|NCT01027351|Secondary|Percentage of Subjects With Persisting Serum Bactericidal Antibodies ≥1:4 and ≥1:8 in Children at 60 Months of Age.|The percentage of subjects with persisting hSBA titers ≥1:4 and ≥1:8 at 60 months of age against N.meningitidis B strains after having received one or two booster doses of either rMenB or rMenB+ OMV NZ vaccine or had received two catch-up doses of rMenB+ OMV NZ vaccine at 40 months of age in the present are reported.|18-20 months after last Men B vaccine; baseline for naïve_6062|The analysis was done on the MITT, 60 months of age, antibody persistence population.||Percentage of subjects||95% Confidence Interval|Number
807904|NCT01027351|Secondary|Persisting Geometric Mean Antibody Titers Against N.Meningitidis B in Children at 60 Months of Age.|The persisting GMTs against N.meningitidis B strains in children at 60 months of age who had received one or two booster doses of either rMenB or rMenB+ OMV NZ vaccine or had received two catch-up doses of rMenB+ OMV NZ vaccine at 40 months of age in the present study are compared with GMTs in vaccine-naïve subjects.|18-20 months after last Men B vaccine; baseline for naïve_6062|The analysis was done on the MITT, 60 months of age, antibody persistence population.||Titers||95% Confidence Interval|Geometric Mean
807905|NCT01027351|Secondary|Percentage of Subjects With a 4-fold Increase in Antibody Titers After Receiving Two Catch up Doses of rMenB+OMV NZ Vaccine, Either at 40 or 60 Months of Age.|The percentages of subjects with four-fold increase in hSBA titers over baseline against N.meningitidis B one month after receiving a two catch-up doses of rMenB+OMV NZ vaccine either at 40 & 42 months or 60 & 62 months of age.|1 month post vaccine dose 2|The analysis was done on the MITT population, 2-dose catch-up regimen.||percentage of subjects||95% Confidence Interval|Number
807906|NCT01027351|Secondary|Geometric Mean Antibody Titers in Children After Two Catch up Doses of rMenB+OMV NZ Vaccine Given, Either at 40 or 60 Months of Age.|The geometric mean antibody titers in children after two catch-up doses of rMenB+OMV NZ vaccine when given either at 40 & 42 months or 60 & 62 months of age are reported.|1 month post vaccine dose two|The analysis was done on the MITT population, 2-dose catch-up regimen.||Titers||95% Confidence Interval|Geometric Mean
807907|NCT01027351|Secondary|Percentage of Subjects With hSBA Titers ≥ 1:4 and ≥1:8 Following Two Catch up Doses of rMenB+OMV NZ Vaccine Given One Month Apart, Either at 40 or 60 Months of Age.|The percentage of subjects with hSBA ≥ 1:4 and ≥ 1:8 after two catch-up doses of rMenB+OMV NZ vaccine when given either at 40 & 42 months or 60 & 62 months of age are reported.|1 month post -vaccine dose two|The analysis was done on the MITT population, 2-dose catch-up regimen.||Percentages of subjects||95% Confidence Interval|Number
807908|NCT01027351|Secondary|Percentage of Subjects With 4-fold Increase in Antibody Titers After Receiving Two Booster Doses of Either rMenB or rMenB+OMV NZ Vaccine at 40 & 42 Months of Age.|The percentages of subjects (who had previously received one dose of MenB vaccine in parent study) displaying 4-fold increase in antibody titers over baseline against N.meningitidis B strains, after receiving two booster doses of either rMenB or rMenB+OMV NZ vaccine at 40 & 42 months of age.|1 month post vaccination|The analysis was done on the MITT population, booster response.||Percentages of subjects||95% Confidence Interval|Number
807909|NCT01027351|Secondary|Percentage of Subjects With Serum Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 After Receiving Two Booster Doses of Either rMenB or rMenB+OMV NZ Vaccine at 40 & 42 Months of Age.|The percentages of subjects (who had previously received one dose of MenB vaccine in parent study) with hSBA ≥ 1:4 and ≥ 1:8, against N.meningitidis B strains after receiving two booster doses of either rMenB or rMenB+OMV NZ vaccine at 40 & 42 months of age.|1 month post vaccination|The analysis was done on the MITT population, booster response.||Percentages of subjects||95% Confidence Interval|Number
807910|NCT01027351|Secondary|Geometric Mean Antibody Titers in Children After Receiving Two Booster Doses of Either rMenB or rMenB+OMV NZ Vaccine at 40 & 42 Months of Age.|The GMTs against N.meningitidis B strains in children (who had previously received one dose MenB vaccine in parent study) after a two booster doses of either rMenB or rMenB+OMV NZ vaccine given at 40 & 42 months of age.|1 month post vaccination|The analysis was done on the MITT population, booster response.||Titers||95% Confidence Interval|Geometric Mean
807911|NCT01027351|Secondary|Percentage of Subjects (Who Previously Received 4 Doses of Men B Vaccine) With 4-fold Increase in Serum Bactericidal Antibody Titers After Receiving a Booster Dose of Either rMenB or rMenB+OMV NZ Vaccine at 40 Months of Age.|"The percentages of subjects (who had previously received four doses MenB vaccine in parent study) showing a 4-fold increase in hSBA titers over baseline against N.meningitidis B strains, after receiving a booster dose of either rMenB or rMen+OMV NZ vaccines at 40 months of age are compared with hSBA responses following one catch-up dose of rMenB+OMV NZ vaccine given at 40 months in vaccine-naive subjects.
Baseline is defined as either the time that the (first) booster dose was given or the time of the first vaccination in this study."|1 month post - booster/ -dose 1 for Naïve|The analysis was done on the MITT population, booster response.||Percentage of subjects||95% Confidence Interval|Number
807912|NCT01027351|Secondary|Percentage of Subjects (Who Previously Received 4 Doses of Men B Vaccine) With Serum Bactericidal Antibody Titers ≥ 1:4 and ≥1:8 After Receiving a Booster Dose of Either rMenB or rMenB+OMV NZ Vaccine at 40 Months of Age.|The percentages of subjects (who had previously received four doses MenB vaccine in parent study) with hSBA titers ≥ 1:4 and ≥ 1:8, against N.meningitidis B strains after receiving a single booster dose of either rMenB or rMen+OMV NZ vaccines at 40 months of age are compared with hSBA responses following one catch-up dose of rMenB+OMV NZ vaccine given at 40 months in vaccine-naive subjects .|1 month post- booster/ dose 1 for Naïve|The analysis was done on the MITT population, booster response.||Percentage of subjects||95% Confidence Interval|Number
807913|NCT01027351|Secondary|Geometric Mean Antibody Titers in Children (Who Previously Received 4 Doses of Men B Vaccine), After Receiving a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at 40 Months of Age.|The GMTs against N.meningitidis B strains in children (who had previously received four doses MenB vaccine in parent study) after a single booster dose of rMenB or rMenB+OMV NZ vaccine given at 40 months of age, are compared with the antibody titers following one catch-up dose rMenB+OMV NZ vaccine given at 40 months to vaccine-naive subjects.|1 month post- booster/ dose 1 for Naïve|The analysis was done on the MITT population, booster response.||Titers||95% Confidence Interval|Geometric Mean
807914|NCT01027351|Secondary|Percentage of Subjects (Who Had Previously Received One Dose of Men B Vaccine) With Persisting Serum Bactericidal Antibody Titers ≥ 1:4 and ≥1:8, at 40 Months of Age.|The percentages of subjects with persisting hSBA titers ≥ 1:4 and ≥1:8, against N.meningitidis B strains at 40 months of age; who had previously received one dose of either rMenB or rMen+OMV NZ vaccines in parent study are reported.|28 months after vaccination; baseline for naïve|The analysis was done on the MITT, 40 months of age, antibody persistence population.||percentage of subjects||95% Confidence Interval|Number
807915|NCT01027351|Secondary|Persistence of Geometric Mean Antibody Titers in Children (Who Previously Received One Dose of Men B Vaccine), at 40 Months of Age.|Persisting GMTs against N.meningitidis B strains in children (at 40 months of age) who had previously received one dose of either rMenB or rMen+OMV NZ vaccines in parent study, are compared with the GMTs in vaccine-naïve children.|28 months after vaccination; Baseline for Naïve|The analysis was done on the MITT, 40 months of age, antibody persistence population.||Titers||95% Confidence Interval|Geometric Mean
807916|NCT01027351|Primary|Number of Subjects Reporting Solicited Adverse Events After a Receiving One or Two Booster Doses of rMen B or rMenB+OMV NZ Vaccine at 40 Months of Age.|The safety and tolerability of one or two booster doses of rMen B or rMenB+OMV NZ vaccine administered at 40 months of age in children who had previously received one or four doses of the same vaccine as infants in parent study is assessed in terms of number of subjects with solicited local and systemic reactions following vaccination.|Day 1-7 after booster vaccination|Analysis was done on the safety population i.e all subjects who received at least one Men B vaccination and provided post-baseline safety data.||participants|||Number
807917|NCT01027351|Primary|Percentage of Subjects (Who Previously Received 4 Doses of Men B Vaccine) With Persisting Human Complement Serum Bactericidal Antibody Titers ≥ 1:4 and ≥1:8 at 40 Months of Age.|"The percentages of subjects with persisting human serum bactericidal antibodies (hSBA) titers ≥ 1:4 and ≥ 1:8, against N.meningitidis B strains at 40 months of age; who had previously received four doses of either rMenB or rMen+OMV NZ vaccines in parent study are reported.
The serum bactericidal antibodies directed against serogroup B meningococci, are measured by human complement Serum Bactericidal Assay (hSBA)."|28 months after last vaccination; baseline for naïve|The analysis was done on the MITT , 40 months of age, antibody persistence population.||Percentages of subjects||95% Confidence Interval|Number
807918|NCT01027351|Primary|Persistence of Geometric Mean Antibody Titers in Children (Who Previously Received 4 Doses of Men B Vaccine), at 40 Months of Age.|Persistence of geometric mean titers (GMTs) against N.meningitidis B strains in children (at 40 months of age) who had previously received four doses of either rMenB or rMen+OMV NZ vaccines in parent study, are compared with the GMTs in vaccine-naïve children.|28 months after last vaccination; Baseline for Naïve|The analysis was done on the Modified- Intended to treat (MITT), 40 months of age, antibody persistence population.||Titers||95% Confidence Interval|Geometric Mean
807967|NCT01027650|Primary|Change From Baseline at Month 1 in BCVA in the Study Eye During Stage 2|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|Baseline, Month 1|Per Protocol Population: all randomized and treated qualified patients with baseline and at least one post-baseline data for retinal thickness or BCVA in the study eye||Number of Letters Read Correctly||Standard Deviation|Mean
807919|NCT01027364|Primary|Comparison of Annualized Bleeding Rates|Estimated with a factor for arm, based on whole study duration for all participants. Annualized bleeding episodes = (number of bleeding episodes / number of days in the respective period)*365.25. In Arms 1 and 2, the efficacy period (EP) started with date and time of first prophylactic dose following a completed PK sampling period and ended with last dose administered (for prophylaxis or a bleeding episode). In Arm 3, the EP started following last PK sampling timepoint and ended with either date of last contact or date of last entry into the eDiary, whichever was later. The EP was interrupted for the repeat PK period in Arm 1 and for all surgical/rehabilitation periods in all 3 arms. A bleeding episode started from the first sign of a bleed, and ended 72 hours after the last treatment for the bleeding, within which any symptoms of bleeding at the same location, or injections less than or equal to 72 hours apart, were considered the same bleeding episode.|up to 52 weeks ± 1 week (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFIXFc.||episodes per participant per year||95% Confidence Interval|Number
807920|NCT01027364|Primary|Annualized Bleeding Rate|Annualized bleeding episodes = (number of bleeding episodes / number of days in the respective period)*365.25. In Arms 1 and 2, the efficacy period (EP) started with date and time of first prophylactic dose following a completed pharmacokinetic (PK) sampling period and ended with last dose administered (for prophylaxis or a bleeding episode). In Arm 3, the EP started following last PK sampling timepoint and ended with either date of last contact or date of last entry into the eDiary, whichever was later. The EP was interrupted for the repeat PK period in Arm 1 (sequential PK subgroup) and for all surgical/rehabilitation periods (for both major and minor surgeries) in all 3 arms. A bleeding episode started from the first sign of a bleed, and ended 72 hours after the last treatment for the bleeding, within which any symptoms of bleeding at the same location, or injections less than or equal to 72 hours apart, were considered the same bleeding episode.|up to 52 weeks ± 1 week (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFIXFc.||episodes per participant per year||Inter-Quartile Range|Median
807921|NCT01027364|Secondary|Coagulation Parameter: Change From Pre-dose Values in D-dimer|Maximum value post-dosing is defined as maximum value over the 1-, 6-, and 24-hour evaluations.|Pre-dose, 1 hour post-dose, 6 hours post-dose, and 24 hours post-dose at baseline (120 hours before Day 1, for BeneFIX), Day 1, Week 26, and Week 52 (for rFIXFc)|The Sequential PK subgroup consisted of all participants who had evaluable PK profiles for both BeneFIX and baseline rFIXFc, and/or evaluable PK profiles for both baseline and repeat rFIXFc at Week 26 (±1 week). n=participants with an assessment at given time point.||ng/mL||Standard Deviation|Mean
807922|NCT01027364|Secondary|Coagulation Parameter: Change From Pre-dose Values in Thrombin-antithrombin (TAT) Complex|Maximum value post-dosing is defined as maximum value over the 1-, 6-, and 24-hour evaluations.|Pre-dose, 1 hour post-dose, 6 hours post-dose, and 24 hours post-dose at baseline (120 hours before Day 1, for BeneFIX), Day 1, Week 26, and Week 52 (for rFIXFc)|The Sequential PK subgroup consisted of all participants who had evaluable PK profiles for both BeneFIX and baseline rFIXFc, and/or evaluable PK profiles for both baseline and repeat rFIXFc at Week 26 (±1 week). n=participants with an assessment at given time point.||ng/mL||Standard Deviation|Mean
807923|NCT01027364|Secondary|Coagulation Parameter: Change From Pre-dose Values in Prothrombin Split Fragments 1+ 2 (F 1+2)|Maximum value post-dosing is defined as maximum value over the 1-, 6-, and 24-hour evaluations.|Pre-dose, 1 hour post-dose, 6 hours post-dose, and 24 hours post-dose at baseline (120 hours before Day 1, for BeneFIX), Day 1, Week 26, and Week 52 (for rFIXFc)|The Sequential PK subgroup consisted of all participants who had evaluable PK profiles for both BeneFIX and baseline rFIXFc, and/or evaluable PK profiles for both baseline and repeat rFIXFc at Week 26 (±1 week). n=participants with an assessment at given time point.||pmol/L||Standard Deviation|Mean
807924|NCT01027364|Secondary|Number of Participants With Clinically Relevant Abnormalities or Relevant Changes From Baseline in Vital Signs|Number of participants with clinically relevant abnormalities or relevant changes from baseline in temperature, pulse (beats per minute [bpm]), systolic blood pressure (SBP), and diastolic blood pressure (DBP) are presented. Baseline (BL) is defined as the last non-missing evaluable assessment taken prior and closest to the first rFIXFc dose. Because the perioperative management period represents a unique clinical situation, safety data obtained during the surgical/rehabilitation period for participants in Arm 4 were included in listings and reviewed separately. Review of the listing was sufficient to assess this endpoint.|up to 52 weeks ± 1 week|Safety Analysis Set: participants who received at least 1 dose of BeneFIX or rFIXFc; a table was not generated for participants in the perioperative management/surgical arm (Arm 4). n=participants with a baseline assessment and at least one post-baseline assessment for temperature or at least one post-baseline assessment for pulse, SBP, and DBP.||participants|||Number
807925|NCT01027364|Secondary|Time to 1% and 3% FIX Activity|Time to reach 1 or 3 IU/dL (%) after a single dose. Assessment of FIX activity with BeneFIX was conducted following a required 120-hour (5-day) washout period, at these timepoints: predose, 10 (±2) minutes, 1 hour (±15 minutes), 3 hours (±15 minutes), 6 hours (±15 minutes), 24 (±2) hours, 48 (±2) hours, 72 (±3) hours, and 96 (±3) hours (4 days) from the start of the injection. Assessment of FIX activity and rFIXFc concentration was conducted following the initial dose of rFIXFc (after a required 120-hour [5-day] washout period) and at Week 26, at these timepoints: predose, 10 (±2) minutes, 1 hour (±15 minutes), 3 hours (±15 minutes), 6 hours (±15 minutes), 24 (±2) hours, 48 (±2) hours, 96 (±3) hours (4 days), 144 (±3) hours (6 days), 168 (±3) hours (7 days), 192 (±3) hours (8 days), and 240 (±3) hours (10 days) from the start of the injection.|See Measure Description for complete time frame. Each participant was to complete PK sampling up to, and including, the 96-hour (4-day) timepoint for BeneFIX PK assessment and the 240-hour (10-day) timepoint for rFIXFc PK assessment.|Participants in the Sequential PK Subgroup who have evaluable PK profiles for both BeneFIX and baseline rFIXFc.||days||95% Confidence Interval|Geometric Mean
807968|NCT01027650|Primary|Change From Baseline at Month 1 in Best Corrected Visual Acuity (BCVA) in the Study Eye During Stage 1|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|Baseline, Month 1|Safety Population: all patients who received study treatment||Number of Letters Read Correctly||Standard Deviation|Mean
808120|NCT01020123|Secondary|QTcF; Electorcardiagram Change From Baseline|Summary statistic of change from baseline|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 258 in CSR)||msec||Standard Deviation|Mean
807926|NCT01027364|Secondary|Incremental Recovery|IU/dL rise in plasma per IU/kg drug administered. Assessment of FIX activity with BeneFIX was conducted following a required 120-hour (5-day) washout period, at these timepoints: predose, 10 (±2) minutes, 1 hour (±15 minutes), 3 hours (±15 minutes), 6 hours (±15 minutes), 24 (±2) hours, 48 (±2) hours, 72 (±3) hours, and 96 (±3) hours (4 days) from the start of the injection. Assessment of FIX activity and rFIXFc concentration was conducted following the initial dose of rFIXFc (after a required 120-hour [5-day] washout period) and at Week 26, at these timepoints: predose, 10 (±2) minutes, 1 hour (±15 minutes), 3 hours (±15 minutes), 6 hours (±15 minutes), 24 (±2) hours, 48 (±2) hours, 96 (±3) hours (4 days), 144 (±3) hours (6 days), 168 (±3) hours (7 days), 192 (±3) hours (8 days), and 240 (±3) hours (10 days) from the start of the injection.|See Measure Description for complete time frame. Each participant was to complete PK sampling up to, and including, the 96-hour (4-day) timepoint for BeneFIX PK assessment and the 240-hour (10-day) timepoint for rFIXFc PK assessment.|Participants in the Sequential PK Subgroup who have evaluable PK profiles for both BeneFIX and baseline rFIXFc.||IU/dL per IU/kg||95% Confidence Interval|Geometric Mean
807927|NCT01027364|Secondary|Volume in Steady State (Vss)|Volume of distribution at steady state. Assessment of FIX activity with BeneFIX was conducted following a required 120-hour (5-day) washout period, at these timepoints: predose, 10 (±2) minutes, 1 hour (±15 minutes), 3 hours (±15 minutes), 6 hours (±15 minutes), 24 (±2) hours, 48 (±2) hours, 72 (±3) hours, and 96 (±3) hours (4 days) from the start of the injection. Assessment of FIX activity and rFIXFc concentration was conducted following the initial dose of rFIXFc (after a required 120-hour [5-day] washout period) and at Week 26, at these timepoints: predose, 10 (±2) minutes, 1 hour (±15 minutes), 3 hours (±15 minutes), 6 hours (±15 minutes), 24 (±2) hours, 48 (±2) hours, 96 (±3) hours (4 days), 144 (±3) hours (6 days), 168 (±3) hours (7 days), 192 (±3) hours (8 days), and 240 (±3) hours (10 days) from the start of the injection.|See Measure Description for complete time frame. Each participant was to complete PK sampling up to, and including, the 96-hour (4-day) timepoint for BeneFIX PK assessment and the 240-hour (10-day) timepoint for rFIXFc PK assessment.|Participants in the Sequential PK Subgroup who have evaluable PK profiles for both BeneFIX and baseline rFIXFc.||mL/kg||95% Confidence Interval|Geometric Mean
807928|NCT01027364|Secondary|Mean Residence Time (MRT)|The average time for all the drug molecules to reside in the body. Assessment of FIX activity with BeneFIX was conducted following a required 120-hour (5-day) washout period, at these timepoints: predose, 10 (±2) minutes, 1 hour (±15 minutes), 3 hours (±15 minutes), 6 hours (±15 minutes), 24 (±2) hours, 48 (±2) hours, 72 (±3) hours, and 96 (±3) hours (4 days) from the start of the injection. Assessment of FIX activity and rFIXFc concentration was conducted following the initial dose of rFIXFc (after a required 120-hour [5-day] washout period) and at Week 26, at these timepoints: predose, 10 (±2) minutes, 1 hour (±15 minutes), 3 hours (±15 minutes), 6 hours (±15 minutes), 24 (±2) hours, 48 (±2) hours, 96 (±3) hours (4 days), 144 (±3) hours (6 days), 168 (±3) hours (7 days), 192 (±3) hours (8 days), and 240 (±3) hours (10 days) from the start of the injection.|See Measure Description for complete time frame. Each participant was to complete PK sampling up to, and including, the 96-hour (4-day) timepoint for BeneFIX PK assessment and the 240-hour (10-day) timepoint for rFIXFc PK assessment.|Participants in the Sequential PK Subgroup who have evaluable PK profiles for both BeneFIX and baseline rFIXFc.||hours||95% Confidence Interval|Geometric Mean
807929|NCT01027364|Secondary|Clearance (CL)|The measure of the efficiency of the body to remove the drug and the unit is the volume of the plasma or blood cleared of drug per unit time. Assessment of FIX activity with BeneFIX was conducted following a required 120-hour (5-day) washout period, at these timepoints: predose, 10 (±2) minutes, 1 hour (±15 minutes), 3 hours (±15 minutes), 6 hours (±15 minutes), 24 (±2) hours, 48 (±2) hours, 72 (±3) hours, and 96 (±3) hours (4 days) from the start of the injection. Assessment of FIX activity and rFIXFc concentration was conducted following the initial dose of rFIXFc (after a required 120-hour [5-day] washout period) and at Week 26, at these timepoints: predose, 10 (±2) minutes, 1 hour (±15 minutes), 3 hours (±15 minutes), 6 hours (±15 minutes), 24 (±2) hours, 48 (±2) hours, 96 (±3) hours (4 days), 144 (±3) hours (6 days), 168 (±3) hours (7 days), 192 (±3) hours (8 days), and 240 (±3) hours (10 days) from the start of the injection.|See Measure Description for complete time frame. Each participant was to complete PK sampling up to, and including, the 96-hour (4-day) timepoint for BeneFIX PK assessment and the 240-hour (10-day) timepoint for rFIXFc PK assessment.|Participants in the Sequential PK Subgroup who have evaluable PK profiles for both BeneFIX and baseline rFIXFc.||mL/h/kg||95% Confidence Interval|Geometric Mean
807930|NCT01027364|Secondary|Half Life (t1/2) Alpha and t1/2 Beta|Time required for the concentration of the drug to reach half of its original value. Alpha and beta half-life indicate distribution and elimination half-life in a two-compartment PK model. Assessment of FIX activity with BeneFIX was conducted following a required 120-hour (5-day) washout period, at these timepoints: predose, 10 (±2) minutes, 1 hour (±15 minutes), 3 hours (±15 minutes), 6 hours (±15 minutes), 24 (±2) hours, 48 (±2) hours, 72 (±3) hours, and 96 (±3) hours (4 days) from the start of the injection. Assessment of FIX activity and rFIXFc concentration was conducted following the initial dose of rFIXFc (after a required 120-hour [5-day] washout period) and at Week 26, at these timepoints: predose, 10 (±2) minutes, 1 hour (±15 minutes), 3 hours (±15 minutes), 6 hours (±15 minutes), 24 (±2) hours, 48 (±2) hours, 96 (±3) hours (4 days), 144 (±3) hours (6 days), 168 (±3) hours (7 days), 192 (±3) hours (8 days), and 240 (±3) hours (10 days) from the start of the injection.|See Measure Description for complete time frame. Each participant was to complete PK sampling up to, and including, the 96-hour (4-day) timepoint for BeneFIX PK assessment and the 240-hour (10-day) timepoint for rFIXFc PK assessment.|Participants in the Sequential PK Subgroup who have evaluable PK profiles for both BeneFIX and baseline rFIXFc.||hours||95% Confidence Interval|Geometric Mean
807947|NCT01027364|Secondary|Annualized Bleeding Rate by Type of Bleed (Spontaneous and Traumatic)|Annualized bleeding episodes = (number of bleeding episodes/number of days in efficacy period)*365.25. Please see the definition of the efficacy period (EP) in the Outcome Measure 4 Description. The EP was interrupted for the repeat PK period in Arm 1 (sequential PK subgroup) and for all surgical/rehabilitation periods (for both major and minor surgeries) in all 3 arms. A bleeding episode started from the first sign of a bleed, and ended 72 hours after the last treatment for the bleeding, within which any symptoms of bleeding at the same location, or injections less than or equal to 72 hours apart, were considered the same bleeding episode. Any bleeding at a different location was a separate bleeding episode regardless of time from the last injection.|up to 52 weeks ± 1 week (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFIXFc with evaluable data.||episodes per participant per year||Inter-Quartile Range|Median
807931|NCT01027364|Secondary|Area Under the Curve (AUC) Per Dose|Dose normalized area under the drug concentration-time curve. Assessment of FIX activity with BeneFIX was conducted following a required 120-hour (5-day) washout period, at these timepoints: predose, 10 (±2) minutes, 1 hour (±15 minutes), 3 hours (±15 minutes), 6 hours (±15 minutes), 24 (±2) hours, 48 (±2) hours, 72 (±3) hours, and 96 (±3) hours (4 days) from the start of the injection. Assessment of FIX activity and rFIXFc concentration was conducted following the initial dose of rFIXFc (after a required 120-hour [5-day] washout period) and at Week 26, at these timepoints: predose, 10 (±2) minutes, 1 hour (±15 minutes), 3 hours (±15 minutes), 6 hours (±15 minutes), 24 (±2) hours, 48 (±2) hours, 96 (±3) hours (4 days), 144 (±3) hours (6 days), 168 (±3) hours (7 days), 192 (±3) hours (8 days), and 240 (±3) hours (10 days) from the start of the injection.|See Measure Description for complete time frame. Each participant was to complete PK sampling up to, and including, the 96-hour (4-day) timepoint for BeneFIX PK assessment and the 240-hour (10-day) timepoint for rFIXFc PK assessment.|Participants in the Sequential PK Subgroup who have evaluable PK profiles for both BeneFIX and baseline rFIXFc.||IU*h/dL per IU/kg||95% Confidence Interval|Geometric Mean
807932|NCT01027364|Secondary|Maximum Concentration (Cmax)|Maximum concentration during a dosing interval. Assessment of FIX activity with BeneFIX was conducted following a required 120-hour (5-day) washout period, at these timepoints: predose, 10 (±2) minutes, 1 hour (±15 minutes), 3 hours (±15 minutes), 6 hours (±15 minutes), 24 (±2) hours, 48 (±2) hours, 72 (±3) hours, and 96 (±3) hours (4 days) from the start of the injection. Assessment of FIX activity and rFIXFc concentration was conducted following the initial dose of rFIXFc (after a required 120-hour [5-day] washout period) and at Week 26, at these timepoints: predose, 10 (±2) minutes, 1 hour (±15 minutes), 3 hours (±15 minutes), 6 hours (±15 minutes), 24 (±2) hours, 48 (±2) hours, 96 (±3) hours (4 days), 144 (±3) hours (6 days), 168 (±3) hours (7 days), 192 (±3) hours (8 days), and 240 (±3) hours (10 days) from the start of the injection.|See Measure Description for complete time frame. Each participant was to complete PK sampling up to, and including, the 96-hour (4-day) timepoint for BeneFIX PK assessment and the 240-hour (10-day) timepoint for rFIXFc PK assessment.|Participants in the Sequential PK Subgroup who have evaluable PK profiles for both BeneFIX and baseline rFIXFc.||IU/dL||95% Confidence Interval|Geometric Mean
807933|NCT01027364|Secondary|Number of Transfusions Required Per Surgery|Number of blood component transfusions during a single surgery.|up to 52 weeks ± 1 week|Participants in Arm 4 who received at least 1 dose of rFIXFc.||surgeries|Major Surgeries||Number
807934|NCT01027364|Primary|Incidence Rate of FIX Inhibitor Development|An inhibitor test result ≥0.6 Bethesda units (BU)/mL, identified and confirmed by re-testing of a second sample obtained within 2 to 4 weeks, was considered positive. Both tests were to be performed using the Nijmegen-modified Bethesda Assay by the central laboratory. The incidence rates along with the 95% CI were summarized for all titers for subjects with 50 or more exposure days (EDs) to rFIXFc and a valid inhibitor test after the 50th exposure. In addition, the incidence rates for all subjects regardless of their exposure days to rFIXFc were also summarized. The 95% CI was calculated using Clopper-Pearson exact method.|up to 52 weeks ± 1 week|Safety Analysis Set: participants who received at least 1 dose of of rFIXFc and who had a valid inhibitor test; n=number of participants with given number of exposure days who had a valid inhibitor test.||percentage of participants||95% Confidence Interval|Number
807935|NCT01027364|Secondary|Estimated Total Blood Loss During Major Surgery||up to 52 weeks ± 1 week|Participants in Arm 4 who received at least 1 dose of rFIXFc.||mL|Major Surgeries|Full Range|Median
807936|NCT01027364|Secondary|Dose Per Injection and Total Dose Required to Maintain Hemostasis During Major Surgery|Mean dose per injection is the average dose for all injections (including loading dose) needed to maintain hemostasis during surgery. Total dose is the sum across all injections (including loading dose) needed to maintain hemostasis during surgery.|up to 52 weeks ± 1 week|Participants in Arm 4 who received at least 1 dose of rFIXFc.||IU/kg|Major Surgeries|Full Range|Median
807937|NCT01027364|Secondary|Number of Injections Required to Maintain Hemostasis During Major Surgery|The number of injections to maintain hemostasis during surgery includes all injections for surgery purposes including the loading dose to the end date/time of surgery.|up to 52 weeks ± 1 week|Participants in Arm 4 who received at least 1 dose of rFIXFc.||injections|Major Surgeries|Full Range|Median
807938|NCT01027364|Secondary|Investigators’/Surgeons’ Assessment of Participants’ Response to rFIXFc for Major Surgery|Based on the first assessment of hemostasis by the surgeon/investigator 24 hours or later post-surgery. Scaled responses: Excellent = 1, Good = 2, Fair = 3, Poor/none = 4.|up to 52 weeks ± 1 week|Participants in Arm 4 who received at least 1 dose of rFIXFc.||responses|Major Surgeries||Number
807939|NCT01027364|Secondary|Hemophilia-Specific Quality of Life Index for Children (Haemo-QoL) Questionnaire: Change From Baseline to Week 26 and Week 52|The Haemo-QoL, a quality of life (QoL) assessment instrument for children and adolescents with hemophilia, was administered to participants from 13- to 17-years-old. This instrument assesses domains specific to living with hemophilia. For the Haemo-QoL, higher scores indicate a worse quality of life. Scores on a scale range between 0 and 100.|Baseline, Week 26, Week 52|No summary analysis was done for this outcome measure due to the small number of participants completing the questionnaire.|||||
807940|NCT01027364|Secondary|Haem-A-QoL Questionnaire for Adults: Change From Baseline to Week 52|The Haem-A-QoL consists of items pertaining to 10 domains specific to living with hemophilia and was administered to adult participants (> 17 years). The areas covered by this instrument are: physical health, feeling, view of yourself, sports/leisure, school/work, dealing with hemophilia, and treatment (all 7 domains, during the last month) and future, family planning, and outlook for the future (all 3 domains, recently). Changes from baseline for the Haem-A-QoL questionnaire are summarized by prestudy treatment regimen (pooled for Arms 1 and 2). Lower scores represent better QoL; therefore, a negative change from baseline represents improvement during the course of the study. Scores on a scale range between 0 and 100.|Baseline, Week 52|Full Analysis Set: participants in the 2 prophylaxis arms (Arms 1 and 2) over 17 years of age who received at least 1 dose of rFIXFc and had an assessment. n=participants who had specified assessment at given timepoint.||units on a scale||Full Range|Median
807966|NCT01027650|Secondary|Change From Baseline at Month 12 in Retinal Thickness in the Study Eye During Stage 1|Retinal thickness is assessed by OCT in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.|Baseline, Month 12|Safety Population: all patients who received study treatment||Microns||Standard Deviation|Mean
807941|NCT01027364|Secondary|Hemophilia-Specific Quality of Life Index for Adults (Haem-A-QoL) Questionnaire: Change From Baseline to Week 26|The Haem-A-QoL consists of items pertaining to 10 domains specific to living with hemophilia and was administered to adult participants (> 17 years). The areas covered by this instrument are: physical health, feeling, view of yourself, sports/leisure, school/work, dealing with hemophilia, and treatment (all 7 domains, during the last month) and future, family planning, and outlook for the future (all 3 domains, recently). Changes from baseline for the Haem-A-QoL questionnaire are summarized by prestudy treatment regimen (pooled for Arms 1 and 2). Lower scores represent better QoL; therefore, a negative change from baseline represents improvement during the course of the study. Scores on a scale range between 0 and 100.|Baseline, Week 26|Full Analysis Set: participants in the 2 prophylaxis arms (Arms 1 and 2) over 17 years of age who received at least 1 dose of rFIXFc and had an assessment. n=participants who had specified assessment at given timepoint.||units on a scale||Full Range|Median
807942|NCT01027364|Secondary|Total Dose Per Injection Required for Resolution of a Bleeding Episode by Location of Bleed|For each bleeding episode at one location, the total dose is the sum of the doses (IU/kg) administered across all injections given to treat that bleeding episode. Please see the definition of the efficacy period (EP) in the Outcome Measure 4 Description. The EP was interrupted for the repeat PK period in Arm 1 (sequential PK subgroup) and for all surgical/rehabilitation periods (for both major and minor surgeries) in all 3 arms. A bleeding episode started from the first sign of a bleed, and ended 72 hours after the last treatment for the bleeding, within which any symptoms of bleeding at the same location, or injections less than or equal to 72 hours apart, were considered the same bleeding episode. Bleeding episodes that presented in multiple locations are included as a single event in the overall summary for dose administered to resolve that bleeding episode but are included in the individual summaries for each location.|up to 52 weeks ± 1 week (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFIXFc, had a bleeding episode, and had complete information on the dose administered to treat a bleeding episode; n=total number of bleeding episodes at this location.||IU/kg||Inter-Quartile Range|Median
807943|NCT01027364|Secondary|Number of Injections Required for Resolution of a Bleeding Episode by Location of Bleed|Please see the definition of the efficacy period (EP) in the Outcome Measure 4 Description. The EP was interrupted for the repeat PK period in Arm 1 (sequential PK subgroup) and for all surgical/rehabilitation periods (for both major and minor surgeries) in all 3 arms. A bleeding episode started from the first sign of a bleed, and ended 72 hours after the last treatment for the bleeding, within which any symptoms of bleeding at the same location, or injections less than or equal to 72 hours apart, were considered the same bleeding episode. All injections given from the initial sign of a bleed until the last date/time within the bleed window were counted. The resolution of a bleed was defined as no sign of bleeding following injection for the bleed. Bleeding episodes that presented in multiple locations are included as a single event in the overall summary for the number of injections to resolve that bleeding episode but are included in summaries for each location.|up to 52 weeks ± 1 week (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFIXFc, had a bleeding episode, and had evaluable efficacy assessments; n=total number of bleeds at given location.||injections||Inter-Quartile Range|Median
807944|NCT01027364|Secondary|Number of Injections Required for Resolution of a Bleeding Episode|In Arms 1 and 2, the efficacy period (EP) started with date and time of first prophylactic dose following a completed PK sampling period and ended with last dose administered (for prophylaxis or a bleeding episode). In Arm 3, the EP started following last PK sampling timepoint and ended with either date of last contact or date of last entry into the eDiary, whichever was later. The EP was interrupted for the repeat PK period in Arm 1 and for all surgical/rehabilitation periods in all 3 arms. A bleeding episode started from the first sign of a bleed, and ended 72 hours after the last treatment for the bleeding, within which any symptoms of bleeding at the same location, or injections less than or equal to 72 hours apart, were considered the same bleeding episode. All injections given from the initial sign of a bleed until the last date/time within the bleed window are counted. The resolution of a bleed is defined as no sign of bleeding following injection for the bleed.|up to 52 weeks ± 1 week (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFIXFc and had at least 1 bleeding episode.||injections|Bleeding Episodes|Inter-Quartile Range|Median
807945|NCT01027364|Secondary|Number of Days From Last Injection to Treat a New Bleeding Episode|Please see the definition of the Efficacy Period (EP) in the Outcome Measure 4 Description. The EP was interrupted for the repeat PK period in Arm 1 (sequential PK subgroup) and for all surgical/rehabilitation periods (for both major and minor surgeries) in all 3 arms. A follow-up injection administered >72 hours after the most recent injection given to treat a bleed was considered a new bleed at the same location and was classified as type=Unknown (bleeding episodes of this type were not evaluable). The first bleed for each participant could not be included in this analysis since there was no previous bleed from which to measure time. The number of days from the last injection to treat a bleed to a new bleeding episode was analyzed across all evaluable bleeding episodes per participant.|up to 52 weeks ± 1 week (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFIXFc and at least 1 evaluable bleeding episode.||days|Evaluable Bleeding Episodes|Inter-Quartile Range|Median
807946|NCT01027364|Secondary|Annualized Bleeding Rate by Location of Bleed (Joint, Muscle, Internal, Skin/Mucosa)|Annualized bleeding episodes = (number of bleeding episodes/number of days in efficacy period)*365.25. Please see the definition of the efficacy period (EP) in the Outcome Measure 4 Description. The EP was interrupted for the repeat PK period in Arm 1 (sequential PK subgroup) and for all surgical/rehabilitation periods (for both major and minor surgeries) in all 3 arms. A bleeding episode started from the first sign of a bleed, and ended 72 hours after the last treatment for the bleeding, within which any symptoms of bleeding at the same location, or injections less than or equal to 72 hours apart, were considered the same bleeding episode. Any bleeding at a different location was a separate bleeding episode regardless of time from the last injection.|up to 52 weeks ± 1 week (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFIXFc with evaluable data.||episodes per participant per year||Inter-Quartile Range|Median
807984|NCT01027910|Secondary|Rate of Progression-free Survival at 6 Months in Participants Who Received PCI-24781/Doxorubicin Combination Administration.||2 years|||participants|||Number
822019|NCT01152385|Secondary|Percentage Change in High-density Lipoprotein Cholesterol (HDL-C)||from baseline to 4 months|The analysis population was prior to rescue treatment (FAS)||Percentage||Standard Deviation|Mean
807948|NCT01027364|Secondary|Average Dosing Interval For the Individualized Interval Prophylaxis Arm|Average dosing interval = sum of days in the included dosing intervals divided by the number of included intervals. Participants could have multiple prophylactic dose interval changes. Prophylactic dosing = from first prophylactic injection received for rFIXFc to the last prophylactic injection on study. Intervals between 2 prophylactic doses separated by a bleed/surgery/PK visit were not included. In Arm 2, the efficacy period (EP) started with date and time of first prophylactic dose following a completed PK sampling period and ended with last dose administered (for prophylaxis or a bleeding episode). The EP was interrupted for all surgical/rehabilitation periods (for both major and minor surgeries).|up to 52 weeks ± 1 week (efficacy period as defined in description)|Full Analysis Set: participants in Arm 2 who received at least 1 dose of rFIXFc with >=6 months on study and evaluable data.||days||Inter-Quartile Range|Median
807949|NCT01027364|Secondary|Average Weekly Dose For the Fixed Weekly Interval Prophylaxis Arm|Average weekly dose = (total IU/kg of all eligible prophylactic doses in the included intervals / total number of days in the included intervals)*7. Eligible dose = the first of the 2 doses defining the interval. Participants could have multiple prophylactic dose changes. Prophylactic dosing = from first prophylactic injection received for rFIXFc to the last prophylactic injection on study. Intervals between 2 prophylactic doses separated by a bleed/surgery/PK visit were not included. In Arm 1, the efficacy period (EP) started with date and time of first prophylactic dose following a completed PK sampling period and ended with last dose administered (for prophylaxis or a bleeding episode). The EP was interrupted for the repeat PK period in Arm 1 (sequential PK subgroup) and for all surgical/rehabilitation periods (for both major and minor surgeries).|up to 52 weeks ± 1 week (efficacy period as defined in description)|Full Analysis Set: participants in Arm 1 who received at least 1 dose of rFIXFc with evaluable data. 'Overall' n=participants with evaluable data; 'Last 3 Months on Study' n=participants with evaluable data and >=6 months on study.||IU/kg||Standard Deviation|Mean
807950|NCT01027364|Secondary|Annualized rFIXFc Consumption Per Participant|Consumption is calculated for the efficacy period (EP). In Arms 1 and 2, the EP started with date and time of first prophylactic dose following a completed PK sampling period and ended with last dose administered (for prophylaxis or a bleeding episode). In Arm 3, the EP started following last PK sampling timepoint and ended with either date of last contact or date of last entry into the eDiary, whichever was later. The EP was interrupted for the repeat PK period in Arm 1 (sequential PK subgroup) and for all surgical/rehabilitation periods (for both major and minor surgeries) in all 3 arms. Overall units (IU/kg) of annualized rFIXFc consumption = [Total rFIXFc IU/kg received during the EP / number of days in EP]*365.25.|up to 52 weeks ± 1 week (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFIXFc with evaluable data in the efficacy period. 'Overall' n=all participants in the Full Analysis Set with evaluable data in the efficacy period; 'Last 3 Months on Study' n=all participants in the Full Analysis Set with evaluable data and >=6 months on study.||IU/kg rFIXFc per participant per year||Standard Deviation|Mean
807951|NCT01027364|Secondary|Physicians’ Global Assessments of Participants’ Response to Treatment With rFIXFc|Physicians assessed each participant's response to rFIXFc using a 4-point scale: excellent=bleeding episodes responded to less than or equal to the usual number of injections or less than or equal to the usual dose of rFIXFc, or the rate of breakthrough bleeding during prophylaxis was less than or equal to that usually observed; effective=most bleeding episodes responded to the same number of injections and dose, but some required more injections or higher doses, or there was a minor increase in the rate of breakthrough bleeding; partially effective=bleeding episodes most often required more injections and/or higher doses than expected, or adequate breakthrough bleeding prevention during prophylaxis required more frequent injections and/or higher doses; ineffective=routine failure to control hemostasis or hemostatic control required additional agents. Percentage of the total count of scale responses for all participants is presented. Multiple responses per participant are counted.|up to 52 weeks ± 1 week|Full Analysis Set: participants who received at least 1 dose of rFIXFc, had evaluable efficacy assessments, and had nonmissing observations at time point.||percentage of responses|Responses||Number
807952|NCT01027364|Secondary|Participant Assessment of Response to Injections to Treat a Bleeding Episode|Participant's assessment of the response to the first rFIXFc injection for each bleeding episode. Percentages were based on the number of bleeding episodes for which a response was provided for the first injection, using the following 4-point scale: excellent=abrupt pain relief and/or improvement in signs of bleeding within approximately 8 hours after the initial injection; good=definite pain relief and/or improvement in signs of bleeding within approximately 8 hours after an injection, but possibly requiring more than one injection after 24 to 48 hours for complete resolution; moderate=probable or slight beneficial effect within 8 hours after the initial injection and requiring more than one injection; no response=no improvement, or condition worsened, within approximately 8 hours after the initial injection.|up to 52 weeks ± 1 week|Full Analysis Set: participants who received at least 1 dose of rFIXFc and had a bleeding episode; participants with a non-evaluable bleeding episode are counted in the 'number of participants analyzed,' but not the percentages.||percentage of responses|Bleeding Episodes||Number
807953|NCT01027364|Primary|Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs) During the Surgical / Rehabilitation Period|SAE=AE resulting in death, immediate risk of death, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, or a congenital/anomaly/birth defect, or any other medically important event. TESAE=SAE present prior to receiving the first injection of BeneFIX or rFIXFc that subsequently worsened in severity or was not present prior to receiving the first injection but subsequently appeared before last visit on study. Participants are counted once if they report multiple events in the same system organ class (SOC) or preferred term (PT). Coded using the Medical Dictionary for Regulatory Activities (MedDRA), version 15.0 dictionary. The following SOC is abbreviated in the table: Injury, Poisoning, and Procedural (IPP).|up to 52 weeks + 30 days ± 1 week|Safety Analysis Set: participants who received at least 1 dose of BeneFIX or rFIXFc. A participant may have been in more than one group (i.e., participants in Arm 4 who were also in Arm 1, 2, or 3; please see Participant Flow for details).||participants|Participants With At Least 1 TESAE||Number
807985|NCT01027910|Secondary|Number of Partial Responses (PR)|number of patients who demonstrated partial response to therapy as determined by RECIST v1.0 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|1 year|||participants|||Number
807954|NCT01027364|Primary|Number of Participants With Non-serious Treatment-emergent Adverse Events (TEAEs) During the Surgical / Rehabilitation Period|AE=any untoward medical occurrence that did not necessarily have a causal relationship with this treatment, and could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study product, whether related or not. TEAE=AE present prior to receiving the first injection of BeneFIX or rFIXFc that subsequently worsened in severity or was not present prior to receiving the first injection but subsequently appeared before last visit on study. Participants are counted once if they report multiple events in the same system organ class (SOC) or preferred term (PT). Coded using the Medical Dictionary for Regulatory Activities (MedDRA), version 15.0 dictionary. The following SOCs are abbreviated in the table: Immune System (IS); Injury, Poisoning, and Procedural (IPP); Metabolism and Nutrition (MN); Musculoskeletal and Connective Tissue (MCT); Respiratory, Thoracic and Mediastinal (RTM); Skin and Subcutaneous Tissue (SST).|up to 52 weeks + 30 days ± 1 week|Safety Analysis Set: participants who received at least 1 dose of BeneFIX or rFIXFc. A participant may have been in more than one group (i.e., participants in Arm 4 who were also in Arm 1, 2, or 3; please see Participant Flow for details).||participants|Participants With At Least 1 TEAE||Number
807955|NCT01027364|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)|AE=any untoward medical occurrence that did not necessarily have a causal relationship with this treatment, and could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study product, whether related or not. TE=event present prior to receiving the first injection of BeneFIX or rFIXFc that subsequently worsened in severity or not present prior to receiving the first injection but subsequently appeared before last visit on study. Serious AE (SAE)=AE resulting in death, immediate risk of death, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, or a congenital/anomaly/birth defect, or any other medically important event. Related=related, possibly related, and relationship missing. Data include AEs emergent during the surgical/rehabilitation period; AE data are included in each treatment arm only for the time each participant was enrolled in that arm.|up to 52 weeks + 30 days ± 1 week|Safety Analysis Set: participants who received at least 1 dose of BeneFIX or rFIXFc. A participant may have been in more than one group (i.e., participants in Arm 4 who were also in Arm 1, 2, or 3; please see Participant Flow for details). Participants with at least one TESAE reported are included in the TEAE count.||participants|||Number
807956|NCT01027364|Primary|Number of Participants With Potentially Clinically Significant Laboratory Abnormalities|Clinical laboratory evaluations included hematology and blood chemistry. Table does not include laboratory tests evaluated during the surgical/rehabilitation period. Because the perioperative management period represents a unique clinical situation, safety data obtained during the surgical/rehabilitation period for participants in Arm 4 were included in listings and reviewed separately. Review of the listing was sufficient to assess this endpoint. ULN=upper limit of normal.|up to 52 weeks ± 1 week|Safety Analysis Set: participants who received at least 1 dose of BeneFIX or rFIXFc; n=the number of participants with at least one post-baseline value. For this study, a table was not generated for potentially clinically significant laboratory abnormalities for participants in the perioperative management/surgical arm (Arm 4).||participants|||Number
807957|NCT01027468|Secondary|Systemic Complications After Treatment, Central Retinal Thickness||3 years after initial bevacizumab treatment||||||
807958|NCT01027468|Primary|Vision||3 years after initial intravitreal bevacizumab treatment||||||
807959|NCT01027468|Primary|Vision||3 years after first intravitreal bevacizumab treatment|||logMar||Standard Deviation|Mean
807960|NCT01027598|Secondary|Objective Response Rate (ORR)|The percentage of patients having an objective benefit from treatment per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.|18 Months|Includes all patients who were evaluated for response||percentage of evaluated participants|||Number
807961|NCT01027598|Secondary|Overall Survival|The length of time, in months, that patients were alive from first date of protocol treatment until death.|18 months|All treated patients||months||95% Confidence Interval|Median
807962|NCT01027598|Primary|Progression-free Survival|The length of time, in months, that patients were alive from first date of protocol treatment until worsening of disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|14 months|All treated patients||months||95% Confidence Interval|Median
807963|NCT01027650|Secondary|Change From Baseline at Month 12 in BCVA in the Study Eye During Stage 2|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|Baseline, Month 12|Per Protocol Population: all randomized and treated qualified patients with baseline and at least one post-baseline data for retinal thickness or BCVA in the study eye||Number of Letters Read Correctly||Standard Deviation|Mean
807964|NCT01027650|Secondary|Change From Baseline at Month 12 in BCVA in the Study Eye During Stage 1|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|Baseline, Month 12|Safety Population: all patients who received study treatment||Number of Letters Read Correctly||Standard Deviation|Mean
807965|NCT01027650|Secondary|Change From Baseline at Month 12 in Retinal Thickness in the Study Eye During Stage 2|Retinal thickness is assessed by OCT in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.|Baseline, Month 12|Per Protocol Population: all randomized and treated qualified patients with baseline and at least one post-baseline data for retinal thickness or BCVA in the study eye||Microns||Standard Deviation|Mean
807986|NCT01027910|Secondary|Dose Limiting Toxicities|number of patients who experienced dose limiting toxicities|1 year|||participants|||Number
807969|NCT01027650|Primary|Change From Baseline at Month 1 in Retinal Thickness in the Study Eye During Stage 2|Retinal thickness is assessed by OCT in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.|Baseline, Month 1|Per Protocol Population: all randomized and treated qualified patients with baseline and at least one post-baseline data for retinal thickness or BCVA in the study eye||Microns||Standard Deviation|Mean
807970|NCT01027650|Primary|Change From Baseline at Month 1 in Retinal Thickness in the Study Eye During Stage 1|Retinal thickness is assessed by optical coherence tomography (OCT) in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.|Baseline, Month 1|Safety Population: all patients who received study treatment||Microns||Standard Deviation|Mean
807971|NCT01027780|Primary|Electroencephalography Measurement|Measurement of alpha asymmetry at the F3/4 (frontal) electrode. Left prefrontal activation has been associated with positive affect, and with higher levels of antibody responses and natural killer cell cytotoxicity.|post-treatment (time 2)|Some subject EEG recordings were excluded from analyses due to reading/equipment factors (e.g., poor signal, external noise) or subject factors (e.g., sleepiness, illness). Subjects were also allowed to opt out of the EEG procedures if desired.||Log right-log left alpha power||Standard Error|Mean
807972|NCT01027780|Primary|Trail Making Test|The Trail Making Test is a commonly used neuropsychological test of visual attention and task-switching. In two timed tasks, subjects are asked to first connect numbers (Test A), then alternating numbers and letters (Test B), in sequential order as quickly as possible. Completion times, relating to cognitive processing speed and executive function (respectively), may be utilized individually, and as a difference (B-A) or ratio (B/A) score. The Trails B/A ratio was used as an index of improvement in executive control throughout the trial, with lower scores indicating better performance.|immediate post-treatment (Time 2)|||Trails B:A score||Standard Error|Mean
807973|NCT01027780|Primary|IgG Anti-KLH Antibody Response Post-treatment|Immune function--specifically, antibody response to a novel, benign antigen (an antigen to which subjects are immunologically naïve); in this case, keyhole limpet hemocyanin (KLH).|Immediate post-treatment (time 2)|||OD 405 nm||Standard Error|Mean
807974|NCT01027819|Secondary|Knee Society Score||6 months||||||
807975|NCT01027819|Primary|Rotational Angle Between Femur and Tibia||2 weeks|The rotational angle between the femur and tibia was collected by postoperative CT and asssessed between the transepicondylar angle in the femur and the vertical line of the AP axis of the tibia(the line between the insertion of the PCL and the medial 1/3 point of the tibial tuberosity).||degree||Standard Deviation|Mean
807976|NCT01027884|Secondary|Percentage of Patients Reporting Adverse Events||52 Weeks|||percentage of patients reporting AEs|||Number
807977|NCT01027884|Secondary|Change From Baseline to Week 52 in Quality of Life Assessed by PedsQL™ Paediatric Quality of Life Inventory|"PedsQL Quality of Life Inventory contains paediatric HRQOL measurements: Physical, Emotional,Social and School Functioning.
Item Scaling:
5-point Likert scale from 0 (Never) to 4 (Almost always). 3-point scale: 0 (Not at all), 2 (Sometimes) and 4 (A lot) for the Young Child (ages 5-7).
Scores are transformed on a scale from 0 to 100 ( 0=100, 1=75, 2=50, 3=25, 4=0) Total Score: Sum of all the items over the number of items answered on all the Scales.
The values reported below are overall scores on Paediatric Quality of Life Inventory in Child/Teen Report. These scores were obtained by averaging scores for all the described subscales. The overall scores range between 0-100 with 0 = worst outcome and 100= best outcome"|Baseline and Week 52|The number of patients (N) in each treatment group is the number of patients with Baseline assessments.||units on a scale||95% Confidence Interval|Mean
807978|NCT01027884|Secondary|Change From Baseline to Week 52 in Muscle Strength|"The change from Baseline to Week 52 in muscle strength as measured by Hand-Held Myometry (HHM) was performed following standardized procedures. As almost all patients were non-ambulatory, only analyses of upper limb muscle strength were performed. Results for elbow flexors and for elbow extensors are reported below.The highest value of 3 consecutive measurements with an interval of at least 10 seconds were recorded.
The HHM was measured using MicroFET2, a digital hand held muscle tester. The selected unit of measure was Newtons (N)."|Baseline and Week 52|The number of patients (N) in each treatment group is the number of patients with baseline assessments||Newtons||95% Confidence Interval|Mean
807979|NCT01027884|Secondary|Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Week 52|Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Week 52|Baseline and Week 52|This analysis was performed on the ITT population(n=64). This population included all randomized patients who received at least one dose of the study medication and provided at least one post-Baseline assessment. It excluded siblings who had been allocated to the same study treatment as a randomized sibling.||percentage of Predicted FVC||95% Confidence Interval|Mean
807980|NCT01027884|Primary|Change From Baseline in Percent Predicted Peak Expiratory Flow (PEF) at Week 52|Change from Baseline in Percent Predicted Peak Expiratory Flow (PEF) at Week 52|Baseline and Week 52|This analysis was performed on the ITT population(n=64). This population included all randomized patients who received at least one dose of the study medication and provided at least one post-Baseline assessment. It excluded siblings who had been allocated to the same study treatment as a randomized sibling.||percentage||95% Confidence Interval|Geometric Mean
807981|NCT01027897|Primary|Elimination Constant (ke)|The elimination rate constant of a drug from the central compartment|after 3rd dose of study drug|Patients that completed the study and did not have atypical variations in the measurement of serum concentrations were included in the final evaluation||per hour||Standard Deviation|Mean
807982|NCT01027897|Primary|Clearance (CL)|Clearance is the volume of drug removed from the body per unit of time (hrs).|After 3rd dose of study medication|Patients that completed the study and did not have atypical variations in the measurement of serum concentrations were included in the final evaluation||liters per hour||Standard Deviation|Mean
807983|NCT01027897|Primary|Volume of Distribution (Vd)|The Volume of distribution is the calculated volume that the given amount of drug is uniformly distributed in the body to achieve a particular concentration|After 3rd dose of study medication|Patients that completed the study and did not have atypical variations in the measurement of serum concentrations were included in the final evaluation||liters||Standard Deviation|Mean
807988|NCT01028014|Other Pre-specified|Difference (Pre - Post) in Maximum Urine Flow Rate (Qmax) (Milliliters Per Second) as Measured by Pressure Flowmetry|Pressure Flowmetry was used to measure maximum urine flow rate (Qmax)before and after 2 weeks of therapy with one of 6 randomly assigned medications. A 300 cc bladder fill was performed through the catheter, the catheter was removed, and transurethral and transrectal pressure transducers were placed for the pressure flow study. Voiding was performed in the seated position. Information obtained for the database included Qmax, average flow rate, time to Qmax, detrusor pressure at maximum flow rate, voided volume, and a calculated post-void residual.|2 weeks|The planned number of participants was per protocol based on power calculation. Actual number may differ based on withdrawal from the study or loss to follow-up.Participants randomized to Pseudoephedrine 120 mg ER,Solifenacin 5 mg, Tamsulosin 0.4mg, Imipramine 25mg, Cyclobenzaprine 10 mg, or a sham Lactose capsule, 1 a day for 14 days.||milliliters per second||Inter-Quartile Range|Median
807989|NCT01028014|Other Pre-specified|Difference (Pre - Post) in Urethral Sensation (Milliamps) as Measured by Current Perception Threshold Testing.|Current Perception Threshold testing was used to measure urethral sensation before and after 2 weeks of therapy with one of 6 randomly assigned medications. We performed CPT testing in the urethra using a Neurometer®, which is a constant current stimulator capable of delivering sine wave electrical stimuli at 3 frequencies (2000 Hz, 250 Hz and 5 Hz). At all 3 frequencies, the stimulus intensity was gradually increased until first perceived, and then decreased until no longer perceptible. CPT values were obtained using a semi-automated forced choice paradigm.|2 weeks|The planned number of participants was per protocol based on power calculation. Actual number may differ based on withdrawal from the study or loss to follow-up.Participants randomized to Pseudoephedrine 120 mg ER,Solifenacin 5 mg, Tamsulosin 0.4mg, Imipramine 25mg, Cyclobenzaprine 10 mg, or a sham Lactose capsule, 1 a day for 14 days.||Milliamps||Inter-Quartile Range|Median
807990|NCT01028014|Primary|Difference (Pre - Post) in Amplitude (Microvolts) of Urethral Sphincter Activity as Measured by Quantitative Concentric Needle EMG|Concentric needle EMG was used to measure urethral sphincter activity at 2-3 sites around the urethral meatus before and after 2 weeks of therapy with one of 6 randomly assigned medications. Two methods of quantitative electromyography were performed on all subjects. (1) Multi-Motor Unit Action Potential (MUP) analysis, which has been shown to be the most sensitive technique in distinguishing neuropathic from control muscles; and (2) interference pattern analysis (IPA) which reflects changes in MUP recruitment from weak effort to maximal contraction.|2 weeks|The planned number of participants was per protocol based on power calculation. Actual number may differ based on withdrawal from the study or loss to follow-up.Participants randomized to Pseudoephedrine 120 mg ER,Solifenacin 5 mg, Tamsulosin 0.4mg, Imipramine 25mg, Cyclobenzaprine 10 mg, or a sham Lactose capsule, 1 a day for 14 days.||microvolts||Inter-Quartile Range|Median
807991|NCT01028027|Secondary|Signs and Symptoms Composite Score Change From Baseline to Day 3 - ITT Population|The CFB to Day 3 in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. ITT population.|Baseline, Day 3|The ITT population was used for this secondary efficacy parameters.||Score on a scale||Standard Deviation|Mean
807992|NCT01028027|Secondary|Signs and Symptoms Composite Score Change From Baseline to Day 3 - PP Population|The CFB to Day 3 in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. PP population.|Baseline, Day 3|The PP population was used for this secondary efficacy parameters.||Score on a scale||Standard Deviation|Mean
807993|NCT01028027|Secondary|Signs and Symptoms Composite Score - Change From Baseline to Day 8 - ITT Population|The CFB to Day 8 in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. ITT population|Baseline, Day 8|The ITT population was used in this secondary efficacy parameter.||Score on a scale||Standard Deviation|Mean
807994|NCT01028027|Secondary|Signs and Symptoms Composite Score - Change From Baseline to Day 8 - PP Population|The CFB to Day 8 (Visit 3) in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score.|Baseline, Day 8|The PP population was used for this secondary efficacy parameters.||Score on a scale||Standard Deviation|Mean
807995|NCT01028027|Secondary|Signs and Symptoms Composite Score - Change From Baseline to Day 15 - ITT Population|The CFB to Day 15 in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. ITT population|Baseline, Day 15|The ITT population was used in this secondary efficacy parameter.||Score on a scale||Standard Deviation|Mean
807996|NCT01028027|Primary|Signs and Symptoms Composite Score - Change From Baseline to Day 15 - PP Population|The change from baseline (CFB) to Day 15 (Visit 4) in the ocular signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. Per protocol population (PP).|Baseline, Day 15|The PP population was the population used for the primary efficacy analysis.||Scores on a scale||Standard Deviation|Mean
807997|NCT01028053|Secondary|The of Normal and Abnormal Subjects Who Convert to Probable Alzheimer’s Disease (pAD) Within the Follow up Period.|Numbers of subjects with normal and abnormal patterns of [18F]flutemetamol uptake who converted to pAD.|Up to 36 months post flutemetamol administration.|Eight Subjects who withdrew prior to the first Clinical Adjudication Committee (CAC) evaluation are not included in the analysis. (232 – 8 = 224 Subjects included).||Number of subjects|||Number
808060|NCT01019694|Secondary|Physician's Global Evaluation at Week 36|"Physicians evaluated the patient's overall clinical condition on a scale ranging from poor (score 1 or 2) to excellent (score 7 or 8)."|36 weeks|Treated Set is defined as all patients who were randomized and received study drug||unit on a scale||Standard Error|Least Squares Mean
807998|NCT01028053|Primary|Hazard Ratio (HR) by PET Scan Readers for Conversion to Probable Alzheimer’s Disease Based on Visual Image Interpretation.|"Visual Interpretation of the PET scan by independent readers.
Note: The statistic Hazard ratio (HR) is the ratio of the hazard rates in the 2 groups (1 group being normal (negative for amyloid B) and 1 group being abnormal (positive for amyloid B). Under the null hypothesis of equal rates, the HR would be equal to 1.
As the HR increases above 1, the chances of being probable Alzheimer’s Disease (pAD) also increases.
Note: Eight Subjects who withdrew prior to the first Clinical Adjudication Committee (CAC) evaluation are not included in the analysis. (232 – 8 = 224 Subjects included)."|Up to 36 months post flutemetamol administration|Eight Subjects who withdrew prior to the first Clinical Adjudication Committee (CAC) evaluation are not included in the analysis. (232 – 8 = 224 Subjects included).||Ratio of visual interpretations|||Number
807999|NCT01028131|Primary|Urinary Cotinine|Cotinine, as measured by urine sample taken and follow-up. Measured as number of participants abstinent by cotinine analysis.|8 week follow-up|||participants|||Number
808000|NCT01028131|Primary|Smoking Behavior (Self-report Confirmed by Expired Breath CO)|All participants were analyzed as assigned. Total N was determined primarily by resource availability in this Stage Ib trial. Number represents number of abstinent participants in each condition.|8 week follow up|||participants|||Number
808001|NCT01028222|Secondary|OS Rate|OS was defined as the time from the date of the start of treatment to the date of death due to any cause.|End of study (up to 39 months)|Full analysis set (FAS): The FAS included all participants to whom treatment was assigned.||Percentage of participants|||Number
808002|NCT01028222|Secondary|PFS Rate|PFS was defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause. Progression is defined using RECIST v1.0, as a >=20% increase in the sum of longest diameter of all target lesions, from smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or unequivocal progression of non-target lesions.|End of study (up to 39 months)|Full analysis set (FAS): The FAS included all participants to whom treatment was assigned.||Percentage of participants|||Number
808003|NCT01028222|Secondary|Disease Control Rate (DCR)|DCR was defined as the proportion of participants with an overall response of CR of any duration, PR of any duration, or stable disease (SD) for a minimum of 12 weeks from start of treatment. Per RECIST, CR: disappearance of all target lesions, all non-target lesions, and no new lesion; PR: a >=30% decrease in the sum of the longest dimensions of the target lesions (TLs) taking as a reference the baseline sum, no unequivocal progression of non-TLs, and no new lesions; PD, a >=20% increase in TLs, clearly worsening of non-TLs, or emergence of new lesions; SD: no change or small changes that do not meet previously given criteria for CR, PR or PD.|End of study (up to 39 months)|Full analysis set (FAS): The FAS included all participants to whom treatment was assigned.||Participants|||Number
808004|NCT01028222|Secondary|Time to Objective Response (TOR)|TOR was defined as the time between the start date of treatment until first documented confirmed response of CR or PR determined by RECIST v1.0 based on local investigators' assessment (CT/MRI/photography). Per RECIST, CR: disappearance of all target lesions, all non-target lesions, and no new lesion; PR: a >=30% decrease in the sum of the longest dimensions of the target lesions (TLs) taking as a reference the baseline sum, no unequivocal progression of non-TLs, and no new lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments at least 4 weeks apart.|End of study (up to 39 months)|Full analysis set (FAS): The FAS included all participants to whom treatment was assigned.||months||95% Confidence Interval|Median
808005|NCT01028222|Secondary|Overall Survival (OS)|OS was defined as the time from the date of the start of treatment to the date of death due to any cause.|End of study (up to 39 months)|Full analysis set (FAS): The FAS included all participants to whom treatment was assigned.||Months||95% Confidence Interval|Median
808006|NCT01028222|Secondary|Progression Free Survival (PFS)|PFS was defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause. Progression is defined using RECIST v1.0, as a >=20% increase in the sum of longest diameter of all target lesions, from smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or unequivocal progression of non-target lesions.|End of study (up to 39 months)|Full analysis set (FAS): The FAS included all participants to whom treatment was assigned.||Months||95% Confidence Interval|Median
808007|NCT01028222|Secondary|Durable Overall Response Rate (DORR)|DORR was defined as the rate of best overall response (CR+PR) lasting at least 12 weeks determined by RECIST v1.0 based on local investigators' assessment (CT/MRI/photography). The duration of ORR responders is computed from the date of first documented response (CR/PR) to the date of first documented progression or death due to underlying disease. Per RECIST, CR: disappearance of all target lesions, all non-target lesions, and no new lesion; PR: a >=30% decrease in the sum of the longest dimensions of the target lesions (TLs) taking as a reference the baseline sum, no worsening of non-TLs, and no new lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments at least 4 weeks apart.|End of study (up to 39 months)|Full analysis set (FAS): The FAS included all participants to whom treatment was assigned.||Participants|||Number
808008|NCT01028222|Primary|Overall Response Rate (ORR)|ORR was defined as the proportion of participants with a best overall response (BOR) of a confirmed complete response or partial response (CR+PR) determined by Response Evaluation Criteria in Solid Tumors (RECIST v1.0) based on local investigators' assessment (CT/MRI/photography). Per RECIST, CR: disappearance of all target lesions, all non-target lesions, and no new lesion; PR: a >=30% decrease in the sum of the longest dimensions of the target lesions (TLs) taking as a reference the baseline sum, no unequivocal progression of non-TLs, and no new lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments at least 4 weeks apart.|End of study (up to 39 months)|Full analysis set (FAS): The FAS included all participants to whom treatment was assigned.||Participants|||Number
808009|NCT01028300|Secondary|No Implant Related Complications||24 months|Study was terminated early due to slow enrollment. 1 subject was enrolled but not treated due to study termination. 1 subject was enrolled and treated, but had no follow-up visits due to study termination. Only Two subjects were seen for follow-up visits, and only at 3 months post surgery.|||||
808010|NCT01028300|Secondary|No Re-operations, Revisions, Removals or Supplemental Fixation||24 months|Study was terminated early due to slow enrollment. 1 subject was enrolled but not treated due to study termination. 1 subject was enrolled and treated, but had no follow-up visits due to study termination. Only Two subjects were seen for follow-up visits, and only at 3 months post surgery.|||||
808012|NCT01028300|Primary|The Primary Endpoint of This Study is the Assessment of the Mean Oswestry Low Back Pain Disability Questionnaire (ODI) Improvement at the Twelve (12) Month and Twenty-four (24) Month Follow-up Visits Relative to Baseline.||24 months|Study was terminated early due to slow enrollment. 1 subject was enrolled but not treated due to study termination. 1 subject was enrolled and treated, but had no follow-up visits due to study termination. Only Two subjects were seen for follow-up visits, and only at 3 months post surgery.|||||
808013|NCT01028352|Secondary|Decrease in Average Pain With 8 Weeks of Duloxetine Therapy. (Sustained)|A secondary measure is the percentage of patients treated with duloxetine who experience a sustained 30% reduction in average pain score from baseline to 8 weeks. Sustained 30% reduction is defined as at least 30% reduction in 24-hour average pain severity at the 8 week endpoint, with a 30% reduction from baseline at a visit at least 2 weeks prior to the last visit, and at least 20% reduction from baseline at every visit in between.|Baseline, 2, 4 , 6 and 8 weeks|||%of participants with 30% pain reduction||95% Confidence Interval|Number
808014|NCT01028352|Primary|Percentage of Patients Who Experience 30% Reduction in Average Pain Score From Baseline to 8 Weeks Due to Duloxetine Therapy.|Subjects were considered evaluable if they met all eligibility criteria and took at least one dose of duloxetine. Average pain was measured using Wisconsin Brief Pain Inventory Questionnaire.(BPI) The BPI is a 17-item patient self-rating scale that assessed sensory & reactive components of pain. The BPI uses 0 to 10 numeric rating scales for item rating.Since pain can be variable,the BPI asks patients to rate pain at completing questionnaire, and also at its worst, least, and average over the previous 24 hours. The primary endpoint is based on the 24-hour avg pain as reported on BPI.|8 weeks|Subjects were considered evaluable for the primary endpoint if they met all eligibility criteria and took at least one dose of duloxetine||percentage of participants|||Number
808015|NCT01028378|Primary|Percentage of Eyes With Best Spectacle-corrected Visual Acuity (BSCVA) Worse Than 20/40 if 20/20 or Better Preoperatively||12 month|||Percentage of Eyes|Participants|95% Confidence Interval|Number
808016|NCT01028378|Primary|Percentage of Eyes With an Increase > 2D Cylinder (Spherical Only)||12 month|||Percentage of Eyes|Participants|95% Confidence Interval|Number
808017|NCT01028378|Primary|Percentage of Eyes With Best Spectacle-Corrected Visual Acuity (BSCVA) Worse Than 20/40||12 month|||Percentage of Eyes|Participants|95% Confidence Interval|Number
808018|NCT01028378|Primary|Percentage of Eyes With Loss of 2 or More Lines Best Spectacle-Corrected Visual Acuity (BSCVA)||12 month|||Percentage of Eyes|Participants|95% Confidence Interval|Number
808019|NCT01028378|Primary|Percentage of Eyes With UCVA 20/40 or Better if BSCVA 20/20 or Better Preoperatively||12 month|||Percentage of Eyes|Participants|95% Confidence Interval|Number
808020|NCT01028378|Primary|Percentage of Eyes With Uncorrected Visual Acuity (UCVA) 20/20 or Better||12 month|||Percentage of Eyes|Participants|95% Confidence Interval|Number
808021|NCT01028378|Primary|Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) +/- 2.00 D||12 month|||Percentage of Eyes|Participants|95% Confidence Interval|Number
808022|NCT01028378|Primary|Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) +/- 1.00 D||12 month|||Percentage of Eyes|Participants|95% Confidence Interval|Number
808023|NCT01028378|Primary|Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) +/- 0.50 D||12 month|||Percentage of Eyes|Participants|95% Confidence Interval|Number
808024|NCT01028391|Secondary|Change From Baseline (i.e., Week 0 of the 24-week Base Study) in Fasting Plasma Glucose (FPG) at Week 54|Change from baseline at Week 54 is defined as Week 54 minus Week 0.|Baseline and Week 54|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 value for this outcome during the extension study. For FAS patients with no data at Week 54, the last observed measurement during extension study was carried forward to Week 54.||mg/dL||95% Confidence Interval|Least Squares Mean
808025|NCT01028391|Primary|Change From Baseline (i.e., Week 0 of the 24-week Base Study) in Hemoglobin A1c (HbA1c) at Week 54|HbA1c is measured as percent. Thus this change from baseline reflects the Week 54 HbA1c percent minus the Week 0 HbA1c percent.|Baseline and 54 Weeks|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 value for this outcome during the 30-week extension study. For FAS patients with no data at Week 54, the last observed measurement during the 30-week extension study was carried forward to Week 54.||Percent HbA1c||95% Confidence Interval|Least Squares Mean
808026|NCT01019135|Secondary|Smoking|Current smoking status|6 months|Participants with available data for current smoking status. Reported values in the table represent number of participants who were current smokers.||Participants|||Number
808027|NCT01019135|Secondary|Medication Adherence|The 4-item Morisky Medication Adherence Scale was used, which is scored as yes = 0, no = 1, such that a higher score indicates higher medication adherence. Scores range from 0 to 4, with patients scoring 2 or above considered adherent.|6 months|Participants with available data for medication adherence||Scores on a scale||Standard Deviation|Mean
808028|NCT01019135|Secondary|Diet|"The Diet Habit Survey was used to assess diet. It is an inexpensive, reliable, and valid instrument for rapid assessment of eating habits and diet composition. Its 9 questions are related to the consumption of cholesterol, saturated fat, complex carbohydrate (including fiber), and salt.
Greater scores indicate better diets, both for the total score and for each area. The total score indicates the level of fat in the diet (with scores equal to or greater than 236 corresponding to a low-fat diet 20% or less). Scores can begin at 56 and have no upper range."|6 months|Participants with available data for diet||Scores on a scale||Standard Deviation|Mean
808029|NCT01019135|Secondary|Self-reported Exercise|"The Godin Leisure-time Exercise Questionnaire will be administered in the pre and post-test surveys. It is a brief and reliable instrument to assess usual leisure-time physical activity behaviour during a one-week period. For the first question, weekly frequencies of strenuous, moderate, and light activities are multiplied by nine, five, and three, respectively. Part two of the questionnaire calculates the frequency of weekly leisure-time activities pursued. Total weekly leisure activity is calculated by summing the products of the separate components. Scores begin at zero, with higher scores indicating greater physical activity. For example, scores equal to or greater than 20 are indicative of someone who is active. There is no max score."|6 months|Participants with available data for self-reported exercise||Scores on a scale||Standard Deviation|Mean
808030|NCT01019135|Secondary|Exercise|Mean daily steps as measured by a pedometer over 7 days|6 months|Participants with available data for exercise||Daily steps||Standard Deviation|Mean
808033|NCT01019317|Primary|Participants With a Complete Response|Complete Response (CR) was defined as: Neutrophil count ≥ 1.0 ×109/L, Platelet count ≥ 100 ×109/L, Bone marrow aspirate ≤5% blasts and No extramedullary leukemia. Response evaluation following Induction Therapy (Cycle 1) and every 2-3 cycles during Consolidation Therapy (Cycles 2 - 7) where Cycle is 4-6 weeks.|Minimally 6 weeks (Cycle 1) up to 1 year (7 cycles)|Of participants enrolled, 147 participants received treatment and were evaluable.||Participants|||Number
808034|NCT01019369|Secondary|Average Minutes Spent Getting Ready for and Giving the Injection|In total, how much time did the participant spend getting ready for and giving the injection. This includes the time the participant spent getting ready to come to the clinic, getting to the appointment, and waiting for the provider for the control group.|0-12 months||||||
808035|NCT01019369|Secondary|Scaled Satisfaction Score|This study was designed to examine if age, parity, partner support, and personal motivation to avoid pregnancy will predict method continuation rates with questionnaires.|6, 12 months||||||
808036|NCT01019369|Secondary|Prevalence of Participants With Persistent Skin Changes|The study was designed to examine if using SC DMPA will cause skin changes (dimpling, induration, or atrophy)|12 months||||||
808037|NCT01019369|Secondary|Number of Participants Who Would Continue With Self Administration of SC DMPA if it Were Available|The study was designed to examine if self administration of SC DMPA is an acceptable alternative to clinic administration of SC DMPA|6, 12 months||||||
808038|NCT01019369|Secondary|Number of Participants Continuing DMPA|The study was designed to examine the increasing accessibility to DMPA by decreasing the need for multiple clinic visits will increase method continuation rates at all other endpoints.|3, 9, 12 months||||||
808039|NCT01019369|Primary|Number of Participants Continuing DMPA at 6 Months|The study was designed to examine if increasing accessibility to DMPA by decreasing the need for multiple clinic visits will increase participant continuation of DMPA|6 months|"Data was analyzed with the assumption that participants who were lost to follow-up had discontinued DMPA use."||participants|||Number
808040|NCT01019486|Secondary|Myocardial Perfusion Index|Myocardial perfusion indices radionuclide stress and rest images and were obtained from 6 regions within the mid ventricular LV short axis slice. Each was corrected for decay and standardized to a 30 mCi administered dose for each part of a two day study.|1 month|||percentage of Ratio Stress/ rest counts||Standard Deviation|Mean
808041|NCT01019486|Secondary|Measured Coronary Blood Flow is Directly Correlated With Coronary Flow Reserve Measured Invasively in the Cardiac Catheterization Laboratory After Regadenoson Pharmacologic Stress.|Regional coronary blood flow reserve (CFR) in a target artery (defined on MPI study) compared to flow in a less diseased atherosclerotic vessel following vasodilator response to intravenously administered regadenoson.|within 6 months|Only 3 individuals met the prescribed perfusion defect on MPI study to proceed to the CFR measurement arm of the study. Therefore numbers were too small for statistical comparison and only mean value and standard deviation of the flow ratio(CFR measurements) are reported..||CFR ratio||Standard Deviation|Mean
808042|NCT01019486|Primary|Coronary Blood Flow Assessment With Regadenoson Stress by Cardiac MRI Between Non-diabetic and Type 1 Diabetic Subjects.|Measurement of Myocardial blood flow measurements (MBF) and myocardial perfusion index obtained from 6 regions within the mid ventricular LV short axis slice.|1 month|"Determine the MBF obtained from cardiac MRI from 6 regions of the mid-ventricular LV myocardium and a ratio between stress/rest myocardial blood flow ratio. Differences between group were compared using a unpaired t test analyzed for: control(Con) vs T1DM low risk; Con. vs T1DM High Risk; and T1DM low vs high risk."||percentage of StressMBF/ Rest MBF||Standard Deviation|Mean
808043|NCT01019694|Secondary|Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Leading to Hospitalization||48 weeks|Treated Set is defined as all patients who were randomized and received study drug||participants|||Number
808044|NCT01019694|Secondary|Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations||48 weeks|Treated Set is defined as all patients who were randomized and received study drug||participants|||Number
808045|NCT01019694|Secondary|Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 48|Mean number of puffs of daily rescue medication use (albuterol use per 24 hour period) in two weeks prior to week 48|48 weeks|Treated Set is defined as all patients who were randomized and received study drug||number of puffs||Standard Error|Least Squares Mean
808046|NCT01019694|Secondary|Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 36|Mean number of puffs of daily rescue medication use (albuterol use per 24 hour period) in two weeks prior to week 36|36 weeks|Treated Set is defined as all patients who were randomized and received study drug||number of puffs||Standard Error|Least Squares Mean
808047|NCT01019694|Secondary|Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 24|Mean number of puffs of daily rescue medication use (albuterol use per 24 hour period) in two weeks prior to week 24|24 weeks|Treated Set is defined as all patients who were randomized and received study drug||number of puffs||Standard Error|Least Squares Mean
808048|NCT01019694|Secondary|Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 12|Mean number of puffs of daily rescue medication use (albuterol use per 24 hour period) in two weeks prior to week 12|12 weeks|Treated Set is defined as all patients who were randomized and received study drug||number of puffs||Standard Error|Least Squares Mean
808049|NCT01019694|Secondary|Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 3|Mean number of puffs of daily rescue medication use (albuterol use per 24 hour period) in two weeks prior to week 3|3 weeks|Treated Set is defined as all patients who were randomized and received study drug||number of puffs||Standard Error|Least Squares Mean
808050|NCT01019694|Secondary|Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 0|Mean number of puffs of daily rescue medication use (albuterol use per 24 hour period) in two weeks prior to week 0|0 weeks|Treated Set is defined as all patients who were randomized and received study drug||number of puffs||Standard Deviation|Mean
808051|NCT01019694|Secondary|Change From Baseline in FVC at Week 48|Change from test-day baseline in Forced Vital Capacity (FVC) at 1 hour post dose at Week 48|baseline, 48 weeks|Treated Set is defined as all patients who were randomized and received study drug||liters||Standard Error|Least Squares Mean
808052|NCT01019694|Secondary|Change From Baseline in FVC at Week 24|Change from test-day baseline in Forced Vital Capacity (FVC) at 1 hour post dose at Week 24|baseline, 24 weeks|Treated Set is defined as all patients who were randomized and received study drug||liters||Standard Error|Least Squares Mean
808062|NCT01019694|Secondary|Physician's Global Evaluation at Week 12|"Physicians evaluated the patient's overall clinical condition on a scale ranging from poor (score 1 or 2) to excellent (score 7 or 8)."|12 weeks|Treated Set is defined as all patients who were randomized and received study drug||unit on a scale||Standard Error|Least Squares Mean
808063|NCT01019694|Secondary|Physician's Global Evaluation at Week 3|"Physicians evaluated the patient's overall clinical condition on a scale ranging from poor (score 1 or 2) to excellent (score 7 or 8)."|3 weeks|Treated Set is defined as all patients who were randomized and received study drug||unit on a scale||Standard Error|Least Squares Mean
808064|NCT01019694|Secondary|Physician's Global Evaluation at Week 0|"Physicians evaluated the patient's overall clinical condition on a scale ranging from poor (score 1 or 2) to excellent (score 7 or 8)."|0 weeks|Treated Set is defined as all patients who were randomized and received study drug||units on a scale||Standard Deviation|Mean
808065|NCT01019694|Secondary|Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 48|CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited).|48 weeks|Treated Set is defined as all patients who were randomized and received study drug||unit on a scale||Standard Error|Least Squares Mean
808066|NCT01019694|Secondary|Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 36|CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited).|36 weeks|Treated Set is defined as all patients who were randomized and received study drug||unit on a scale||Standard Error|Least Squares Mean
808067|NCT01019694|Secondary|Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 24|CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited).|24 weeks|Treated Set is defined as all patients who were randomized and received study drug||unit on a scale||Standard Error|Least Squares Mean
808068|NCT01019694|Secondary|Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 12|CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited).|12 weeks|Treated Set is defined as all patients who were randomized and received study drug||unit on a scale||Standard Error|Least Squares Mean
808069|NCT01019694|Secondary|Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 3|CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited).|3 weeks|Treated Set is defined as all patients who were randomized and received study drug||unit on a scale||Standard Error|Least Squares Mean
808070|NCT01019694|Secondary|Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 0|CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited).|0 weeks|Treated Set is defined as all patients who were randomized and received study drug||units on a scale||Standard Deviation|Mean
808071|NCT01019694|Secondary|Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 48|"Patient satisfaction was assessed by asking: Overall, how satisfied are you with your inhaler?. Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied)."|48 weeks|Treated Set is defined as all patients who were randomized and received study drug||unit on a scale||Standard Error|Least Squares Mean
808072|NCT01019694|Secondary|Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 36|"Patient satisfaction was assessed by asking: Overall, how satisfied are you with your inhaler?. Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied)."|36 weeks|Treated Set is defined as all patients who were randomized and received study drug||unit on a scale||Standard Error|Least Squares Mean
808073|NCT01019694|Secondary|Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 24|"Patient satisfaction was assessed by asking: Overall, how satisfied are you with your inhaler?. Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied)."|24 weeks|Treated Set is defined as all patients who were randomized and received study drug||unit on a scale||Standard Error|Least Squares Mean
808074|NCT01019694|Secondary|Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 12|"Patient satisfaction was assessed by asking: Overall, how satisfied are you with your inhaler?. Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied)."|12 weeks|Treated Set is defined as all patients who were randomized and received study drug||unit on a scale||Standard Error|Least Squares Mean
808075|NCT01019694|Secondary|Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 3|"Patient satisfaction was assessed by asking: Overall, how satisfied are you with your inhaler?. Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied)."|3 weeks|Treated Set is defined as all patients who were randomized and received study drug||unit on a scale||Standard Error|Least Squares Mean
808076|NCT01019694|Secondary|Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 0|"Patient satisfaction was assessed by asking: Overall, how satisfied are you with your inhaler?. Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied)."|0 weeks|Treated Set is defined as all patients who were randomized and received study drug||units on a scale||Standard Deviation|Mean
808077|NCT01019694|Secondary|Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 36|Patient acceptability was assessed with the Performance Domain score from the PASAPQ. The score is a mean of 7 items on a scale from 0 (very dissatisfied) to 100 (very satisfied).|36 weeks|Treated Set is defined as all patients who were randomized and received study drug||unit on a scale||Standard Error|Least Squares Mean
808078|NCT01019694|Secondary|Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 24|Patient acceptability was assessed with the Performance Domain score from the PASAPQ. The score is a mean of 7 items on a scale from 0 (very dissatisfied) to 100 (very satisfied).|24 weeks|Treated Set is defined as all patients who were randomized and received study drug||unit on a scale||Standard Error|Least Squares Mean
808079|NCT01019694|Secondary|Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 12|Patient acceptability was assessed with the Performance Domain score from the PASAPQ. The score is a mean of 7 items on a scale from 0 (very dissatisfied) to 100 (very satisfied).|12 weeks|Treated Set is defined as all patients who were randomized and received study drug||unit on a scale||Standard Error|Least Squares Mean
808080|NCT01019694|Secondary|Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 3|Patient acceptability was assessed with the Performance Domain score from the PASAPQ. The score is a mean of 7 items on a scale from 0 (very dissatisfied) to 100 (very satisfied).|3 weeks|Treated Set is defined as all patients who were randomized and received study drug||unit on a scale||Standard Error|Least Squares Mean
808081|NCT01019694|Primary|Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 48|Patient acceptability was assessed with the Performance Domain score from the PASAPQ. The score is a mean of 7 items on a scale from 0 (very dissatisfied) to 100 (very satisfied).|48 weeks|Treated Set is defined as all patients who were randomized and received study drug||unit on a scale||Standard Error|Least Squares Mean
808082|NCT01019707|Primary|Heart Rate|Based on 8 timepoints post MA infusion, data were pooled and the mean value and standard deviation are presented. Timepoints assessed were collected at 2, 5, 10, 15, 30, 45, 60, 90 minutes following infusion.|Timepoints post MA infusion|||BPM|Timepoints|Standard Deviation|Mean
808083|NCT01019707|Primary|Diastolic Blood Pressure|Based on 8 timepoints post MA infusion, data were pooled and the mean value and standard deviation are presented. Timepoints assessed were collected at 2, 5, 10, 15, 30, 45, 60, 90 minutes following infusion.|Timepoints post MA infusion|||mm Hg|Timepoints post infusion|Standard Deviation|Mean
808084|NCT01019707|Primary|Systolic Blood Pressure|Based on 8 timepoints post MA infusion, data were pooled and the mean value and standard deviation are presented. Timepoints assessed were collected at 2, 5, 10, 15, 30, 45, 60, 90 minutes following infusion.|Timepoints post MA infusion|||mm Hg|Timepoints|Standard Deviation|Mean
808085|NCT01019928|Secondary|Clinically Relevant Change of Laboratory Variables|Number of participants with clinically relevant change of laboratory variables(clinical chemistry, haematology and urinalysis parameters)|Pre-entry to follow-up|||Participants|||Number
808086|NCT01019928|Secondary|Body Temperature|Oral Body Temperature at 1.5 hours post dose|1.5 hours post dose|||degrees Celsius||Standard Deviation|Mean
808087|NCT01019928|Secondary|QTcF|QT interval corrected for heart rate using Fredericia formula(QTcF) at 1.5 hours post dose|1.5 hours post dose|||ms||Standard Deviation|Mean
808088|NCT01019928|Secondary|Pulse|Supine Pulse at 1.5 hours post dose|1.5 hours post dose|||beats/min||Standard Deviation|Mean
808089|NCT01019928|Secondary|DBP|Supine Diastolic Blood Pressure at 1.5 hours post dose|1.5 hours post dose|||mmHg||Standard Deviation|Mean
808090|NCT01019928|Secondary|SBP|Supine Systolic Blood Pressure at 1.5 hours post dose|1.5 hours post dose|||mmHg||Standard Deviation|Mean
808091|NCT01019928|Secondary|Tmax|Time of maximum plasma concentration|0 to 4 hours post dose|||hours||Full Range|Median
808092|NCT01019928|Secondary|Cmax|Maximum plasma concentration|0 to 4 hours post dose|||nmol/L||95% Confidence Interval|Geometric Mean
808093|NCT01019928|Secondary|AUCt|Area under the plasma concentration curve from time zero to the last quantifiable concentration|0 to 4 hours post dose|||nmol*h/L||95% Confidence Interval|Geometric Mean
808094|NCT01019928|Secondary|Current at Visual Analogue Scale 7 (VAS7) During Electrical Stimulation at 2.5 Hours Post Dose|"A probe (bag) was inserted 7cm above the lower esophageal sphincter (LES) and stimulations were performed at approximately 8 cm above the LES. The intensity of the stimuli is increased steadily in steps of 0.5 to 1 mA and the intensity corresponding to the VAS levels 1, 3, 5 and 7 were recorded.
The current will be increased until the patient report moderate pain (VAS 7) or max 80 mA.
The intensities of the non-painful sensations were scored with the following descriptors added to facilitate the scoring:
= vague perception of mild sensation
= definite perception of mild sensation
= vague perception of moderate sensation
= definite perception of moderate sensation
For painful sensations the patients will use the scale from 5-10 anchored at:
= pain detection
= slight pain
= moderate pain
= medium pain intensity
= intense pain
= unbearable pain"|2.5 hours post dose|||mA||Full Range|Geometric Mean
808095|NCT01019928|Secondary|Current at Visual Analogue Scale 7 (VAS7) During Electrical Stimulation at 1.5 Hours Post Dose|"A probe (bag) was inserted 7cm above the lower esophageal sphincter (LES) and stimulations were performed at approximately 8 cm above the LES. The intensity of the stimuli is increased steadily in steps of 0.5 to 1 mA and the intensity corresponding to the VAS levels 1, 3, 5 and 7 were recorded.
The current will be increased until the patient report moderate pain (VAS 7) or max 80 mA.
The intensities of the non-painful sensations were scored with the following descriptors added to facilitate the scoring:
= vague perception of mild sensation
= definite perception of mild sensation
= vague perception of moderate sensation
= definite perception of moderate sensation
For painful sensations the patients will use the scale from 5-10 anchored at:
= pain detection
= slight pain
= moderate pain
= medium pain intensity
= intense pain
= unbearable pain"|1.5 hours post dose|||mA||Full Range|Geometric Mean
808096|NCT01019928|Secondary|Current at Visual Analogue Scale 7 (VAS7) During Electrical Stimulation 0.5 Hours Post Dose|"A probe (bag) was inserted 7cm above the lower esophageal sphincter (LES) and stimulations were performed at approximately 8 cm above the LES. The intensity of the stimuli is increased steadily in steps of 0.5 to 1 mA and the intensity corresponding to the VAS levels 1, 3, 5 and 7 were recorded.
The current will be increased until the patient report moderate pain (VAS 7) or max 80 mA.
The intensities of the non-painful sensations were scored with the following descriptors added to facilitate the scoring:
= vague perception of mild sensation
= definite perception of mild sensation
= vague perception of moderate sensation
= definite perception of moderate sensation
For painful sensations the patients will use the scale from 5-10 anchored at:
= pain detection
= slight pain
= moderate pain
= medium pain intensity
= intense pain
= unbearable pain"|0.5 hours post dose|||mA||Full Range|Geometric Mean
808097|NCT01019928|Secondary|Volume at Visual Analogue Scale 7 (VAS7) During Mechanical Stimulation at 2.5 Hours Post-Dose.|"A probe (bag) was inserted 7cm above the lower esophageal sphincter (LES). Volume change in the bag was recorded continuously at each level of the visual analogue scale (VAS) and up to VAS7 (Volume at Visual Analogue Scale 7).
The intensities of the non-painful sensations were scored with the following descriptors added to facilitate the scoring:
= vague perception of mild sensation
= definite perception of mild sensation
= vague perception of moderate sensation
= definite perception of moderate sensation
For painful sensations the patients will use the scale from 5-10 anchored at:
= pain detection
= slight pain
= moderate pain
= medium pain intensity
= intense pain
= unbearable pain"|2.5 hours post dose|||ml||Full Range|Geometric Mean
822020|NCT01152385|Secondary|Percentage Change in Low-density Lipoprotein Cholesterol (LDL-C)||from baseline to 4 months|The analysis population was prior to rescue treatment (FAS)||Percentage||Standard Deviation|Mean
808098|NCT01019928|Secondary|Volume at Visual Analogue Scale 7 (VAS7) During Mechanical Stimulation at 1.5 Hours Post-Dose|"A probe (bag) was inserted 7cm above the lower esophageal sphincter (LES). Volume change in the bag was recorded continuously at each level of the visual analogue scale (VAS) and up to VAS7 (Volume at Visual Analogue Scale 7).
The intensities of the non-painful sensations were scored with the following descriptors added to facilitate the scoring:
= vague perception of mild sensation
= definite perception of mild sensation
= vague perception of moderate sensation
= definite perception of moderate sensation
For painful sensations the patients will use the scale from 5-10 anchored at:
= pain detection
= slight pain
= moderate pain
= medium pain intensity
= intense pain
= unbearable pain"|1.5 hours post dose|||ml||Full Range|Geometric Mean
808099|NCT01019928|Secondary|Volume at Visual Analogue Scale 7 (VAS7) During Mechanical Stimulation at 0.5 Hours Post Dose|"A probe (bag) was inserted 7cm above the lower esophageal sphincter (LES). Volume change in the bag was recorded continuously at each level of the visual analogue scale (VAS) and up to VAS7 (Volume at Visual Analogue Scale 7).
The intensities of the non-painful sensations were scored with the following descriptors added to facilitate the scoring:
= vague perception of mild sensation
= definite perception of mild sensation
= vague perception of moderate sensation
= definite perception of moderate sensation
For painful sensations the patients will use the scale from 5-10 anchored at:
= pain detection
= slight pain
= moderate pain
= medium pain intensity
= intense pain
= unbearable pain"|0.5 hours post dose|||ml||Full Range|Geometric Mean
808100|NCT01019928|Secondary|Time to Visual Analogue Scale 7 (VAS7) During Thermal Stimulation at 2.5 Hours Post Dose|"A probe (bag) was inserted 7cm above the lower esophageal sphincter (LES). Heat stimuli were applied by recirculation of heated water in the bag. Prior to recirculation the bag is filled with 7mL to ensure adequate mucosal contact. Water was heated up to a maximum of 63° C and the stimulation was continued until VAS 7 was reached.
The intensities of the non-painful sensations were scored with the following descriptors added to facilitate the scoring:
= vague perception of mild sensation
= definite perception of mild sensation
= vague perception of moderate sensation
= definite perception of moderate sensation
For painful sensations the patients will use the scale from 5-10 anchored at:
= pain detection
= slight pain
= moderate pain
= medium pain intensity
= intense pain
= unbearable pain"|2.5 hours post dose|||seconds||Full Range|Geometric Mean
808101|NCT01019928|Secondary|Time to Visual Analogue Scale 7 (VAS7) During Thermal Stimulation at 0.5 Hours Post Dose|"A probe (bag) was inserted 7cm above the lower esophageal sphincter (LES). Heat stimuli were applied by recirculation of heated water in the bag. Prior to recirculation the bag is filled with 7mL to ensure adequate mucosal contact. Water was heated up to a maximum of 63° C and the stimulation was continued until VAS 7 was reached.
The intensities of the non-painful sensations were scored with the following descriptors added to facilitate the scoring:
= vague perception of mild sensation
= definite perception of mild sensation
= vague perception of moderate sensation
= definite perception of moderate sensation
For painful sensations the patients will use the scale from 5-10 anchored at:
= pain detection
= slight pain
= moderate pain
= medium pain intensity
= intense pain
= unbearable pain"|0.5 hours post dose|||seconds||Full Range|Geometric Mean
808102|NCT01019928|Primary|Time to Visual Analogue Scale 7 (VAS7) During Thermal Stimulation at 1.5 Hours Post-Dose.|"A probe (bag) was inserted 7cm above the lower esophageal sphincter (LES). Heat stimuli were applied by recirculation of heated water in the bag. Prior to recirculation the bag is filled with 7mL to ensure adequate mucosal contact. Water was heated up to a maximum of 63° C and the stimulation was continued until VAS 7 was reached.
The intensities of the non-painful sensations were scored with the following descriptors added to facilitate the scoring:
= vague perception of mild sensation
= definite perception of mild sensation
= vague perception of moderate sensation
= definite perception of moderate sensation
For painful sensations the patients will use the scale from 5-10 anchored at:
= pain detection
= slight pain
= moderate pain
= medium pain intensity
= intense pain
= unbearable pain"|1.5 hours post dose|||seconds||Full Range|Geometric Mean
808103|NCT01019980|Secondary|The Level of Knowledge That Parents or Legal Representatives Have on the Treatment of Fever||2 hours||||||
808104|NCT01019980|Secondary|Safety of Diclofenac Potassium Therapy in the Study Period||6 hours||||||
808105|NCT01019980|Secondary|Time With a Temperature ≤ 38,4 °C in a Period of 6 Hours||6 hours||||||
808106|NCT01019980|Secondary|Time to Reach a Reduction of Temperature as 0.5 and 1 °C||2 hours||||||
808107|NCT01019980|Primary|The Reduction of Temperature||2 hours||||||
808108|NCT01020006|Primary|Number of Participants With Treatment Emergent Adverse Events (AEs)|Clinically meaningful toxicity adverse events will be defined in accordance with by CTCAE v3.0|First dose until 28 days after last dose of PCI-27483 or gemcitabine whichever occurs last in the assigned part (A or B).|||participants|||Number
808109|NCT01020123|Secondary|EC50 to Characterise the PD Properties of AZD1656.|The value is model based. The value is independent treatment given.|at 4 month|||nmol/L||Standard Error|Mean
808110|NCT01020123|Secondary|CL/F to Characterise the PK Properties of AZD1656.|The value is calculated using an allometric model (of a patient weighting 75 kg). The value is independent treatment given.|at 4 month|||L/h||Standard Error|Mean
808111|NCT01020123|Secondary|Bilirubin; Change From Baseline|Summary statistic of change from baseline|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 209 in CSR)||mg/dL||Standard Deviation|Mean
808112|NCT01020123|Secondary|Alkaline Phosphatase; Change From Baseline|Summary statistic of change from baseline|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 208 in CSR)||IU/L||Standard Deviation|Mean
808113|NCT01020123|Secondary|AST; Change From Baseline|Summary statistic of change from baseline|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 207 in CSR)||IU/L||Standard Deviation|Mean
808114|NCT01020123|Secondary|ALT; Change From Baseline|Summary statistic of change from baseline|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 206 in CSR)||IU/L||Standard Deviation|Mean
808115|NCT01020123|Secondary|Creatinine; Change From Baseline|Summary statistic of change from baseline|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 211 in CSR)||IU/L||Standard Deviation|Mean
808116|NCT01020123|Secondary|Potassium; Change From Baseline|Summary statistic of change from baseline|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 214 in CSR)||mEq/L||Standard Deviation|Mean
808125|NCT01020123|Secondary|C-reactive Protein: Change From Baseline|Geometric mean ratio (safety analysis set, regardless of rescue) and a 95 % CI|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 234 in CSR)||ratio||95% Confidence Interval|Geometric Mean
808126|NCT01020123|Secondary|Triglycerides: Change From Baseline|Summary statistic of change from baseline|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 226 in CSR)||mg/dL||Standard Deviation|Mean
808127|NCT01020123|Secondary|Total Cholesterol: Change From Baseline|Geometric mean ratio (safety analysis set, regardless of rescue) and a 95 % CI.|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 232 in CSR)||ratio||95% Confidence Interval|Geometric Mean
808128|NCT01020123|Secondary|HDL-C: Change From Baseline|Geometric mean ratio (safety analysis set, regardless of rescue) and a 95 % CI.|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 230 in CSR)||ratio||95% Confidence Interval|Geometric Mean
808129|NCT01020123|Secondary|LDL-C: Mean Ratio|Geometric mean ratio (safety analysis set, regardless of rescue) and a 95 % CI.|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 228 in CSR)||ratio||95% Confidence Interval|Geometric Mean
808130|NCT01020123|Secondary|HbA1c ≤ 6.5|Number of Responders ≤ 6.5, FAS Prior to Rescue|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 228 in CSR).||Participants|||Number
808131|NCT01020123|Secondary|HbA1c ≤ 7|Number of responders ≤ 7, FAS prior to rescue.|baseline to 4 month|The population is FAS prior to rescue, using the observed cases (see table 35 in CSR).||Participants|||Number
808132|NCT01020123|Secondary|OGTT/Pro-insulin/Insulin|The relative change, FAS prior to rescue|baseline to 4 month|The population is FAS prior to rescue, using the LOCF values (see table 154 in CSR)The first 50% of patients enrolled in the study were supposed to undertake OGTT, actual number participating was 52%. However, more than 60% of the OGTT patients were excluded from the analyses, as their measurements did not comply with the protocol||Ratio||95% Confidence Interval|Geometric Mean
808133|NCT01020123|Secondary|OGTT/C-peptide|The relative change, FAS prior to rescue|baseline to 4 month|The population is FAS prior to rescue, using the LOCF values (see table 150 in CSR)The first 50% of patients enrolled in the study were supposed to undertake OGTT, actual number participating was 52%. However, more than 60% of the OGTT patients were excluded from the analyses, as their measurements did not comply with the protocol||ratio||95% Confidence Interval|Geometric Mean
808134|NCT01020123|Secondary|OGTT/Insulin|The Relative Change in AUC FAS Prior to Rescue|baseline to 4 month|The population is FAS prior to rescue, using the LOCF values (see table 146 in CSR)The first 50% of patients enrolled in the study were supposed to undertake OGTT, actual number participating was 52%. However, more than 60% of the OGTT patients were excluded from the analyses, as their measurements did not comply with the protocol||ratio||95% Confidence Interval|Geometric Mean
808135|NCT01020123|Secondary|OGTT/Plasma Glucose|The relative change in AUC|baseline to 4 month|The population is FAS prior to rescue, using the LOCF values (see table 142 in CSR)The first 50% of patients enrolled in the study were supposed to undertake OGTT, actual number participating was 52%. However, more than 60% of the OGTT patients were excluded from the analyses, as their measurements did not comply with the protocol||ratio||95% Confidence Interval|Geometric Mean
808136|NCT01020123|Secondary|SMPG: Change From Baseline to 4 Month, Compared With Placebo, FAS Prior to Rescue.|AZD1656 is analyzed in a ANCOVA model (Glipized and Open Label is Not Included in the model), FAS Prior to Rescue.|baseline to 4 month|The population is FAS prior to rescue, using the LOCF values (see table 31 in CSR)||mmol/L||95% Confidence Interval|Mean
808137|NCT01020123|Secondary|FPG: to Evaluate Change From Baseline to 4 Month, Compared With Placebo, FAS Prior to Rescue.|AZD1656 is analyzed in a ANCOVA model (Glipized and Open Label is Not Included in the model), FAS Prior to Rescue.|baseline to 4 month|The population is FAS prior to rescue, using the LOCF values (see table 29 in CSR)||mmol/L||95% Confidence Interval|Mean
808138|NCT01020123|Primary|HbA1c: Change From Baseline to 4 Month|AZD1656 is analyzed in a ANCOVA model (Glipized and Open Label is Not Included in the model), FAS Prior to Rescue|Baseline to 4th Month|The population is FAS prior to rescue, using the LOCF values (see table 27 in CSR)||Percentage||95% Confidence Interval|Mean
808139|NCT01020305|Primary|Reduction in Serum PSA|Proportion of subjects with > 50% drop in serum PSA as compared to baseline, assessed at 16 weeks|12 weeks treatment, with primary outcome assessed at 16 weeks|||participants|||Number
808140|NCT01020448|Secondary|Safety, Assessed Through the Collection of Adverse Events (AEs)||For the duration of the study (up to month 6)|||participants|||Number
808141|NCT01020448|Secondary|PSA Level||At baseline, month 1, 3 and 6 post-treatment|Analysis based on number (N) of patients with a valid value. ITT population.||μg/L||Full Range|Median
808142|NCT01020448|Secondary|Proportion of Patients Medically Castrated (i.e. With Serum Testosterone Levels of <50 ng/dL)||At month 1, 3 and 6 post-treatment|Analysis based on number (N) of patients with a valid value. ITT population.||percentage of participants|||Number
808143|NCT01020448|Secondary|TMPRSS2-ERG Score (Expressed as a Ratio of T2-ERG mRNA Over PSA mRNA)|"TMPRSS2-ERG = (TMPRSS2-ERG mRNA / PSA mRNA) x 100000
A TMPRSS2-ERG score <35 was described as 'negative' and a TMPRSS2-ERG score ≥35 as 'positive.'"|At baseline, month 1, 3 and 6 post-treatment|Analysis based on number (N) of patients with a valid value. ITT population.||participants|||Number
808144|NCT01020448|Secondary|PCA3 Score Expressed as a Ratio of PCA3 mRNA Over PSA mRNA|"PCA-3 score = (mRNA PCA3/mRNA PSA)x1000
Non-assessable = Associated PSA mRNA <7500 copies/mL
≤BLQ = PCA-3 mRNA is below the concentration of the calibrator and associated PSA mRNA >7500 copies/mL
<35 = PCA-3 mRNA above BLQ and less than 35
≥35 = PCA-3 mRNA greater or equal to 35"|At month 1 and 3 post-treatment|Analysis based on number (N) of patients with a valid value. Intention-to-treat (ITT) population.||participants|||Number
808145|NCT01020448|Primary|PCA3 Score Expressed as a Ratio of PCA3 mRNA (Messenger Ribonucleic Acid) Over PSA (Prostate Specific Antigen) mRNA|"PCA-3 score = (mRNA PCA3/mRNA PSA)x1000
Non-assessable = Associated PSA mRNA <7500 copies/mL
≤BLQ = PCA-3 mRNA is below the concentration of the calibrator and associated PSA mRNA >7500 copies/mL
<35 = PCA-3 mRNA above BLQ and less than 35
≥35 = PCA-3 mRNA greater or equal to 35"|At month 6 post-treatment|Number of participants analyzed were 298 as one participant was admitted to an asylum and was withdrawn before month 1 visit was scheduled. No post-baseline assessment was available for this patient.||participants|||Number
808146|NCT01020474|Secondary|Proportion of Patient Global Impression Change (PGIC) at Week 15|Responder rates based on PGIC was derived and tabulated by treatment group. A responder was defined as a participant who reports much improved or very much improved. The PGIC is a patient-rated single item that measures patient's perception of change in their overall status since starting study medication on a scale ranging from 1 (very much improved) to 7 (very much worse).|Week 15|The FAS population consists of all randomized participants who received at least one dose of study medication.||percentage of participants|||Number
808147|NCT01020474|Secondary|Proportion of 50% Responder in Weekly Mean Pain Score (NRS) at Week 15|At each visit, participants with at least 50% reduction from Baseline in mean pain score were defined as a 50% responder at the visit. The pain NRS consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain).|Week 15|The FAS population consists of all randomized participants who received at least one dose of study medication. mBOCF for participants with missing Week 15 mean pain score.||percentage of participants|||Number
808148|NCT01020474|Secondary|Proportion of 30% Responders in Weekly Mean Pain Score (NRS) at Week 15|At each visit, participants with at least 30% reduction from Baseline in mean pain score were defined as a 30% responder at the visit. The pain NRS consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain).|Week 15|The FAS population consists of all randomized participants who received at least one dose of study medication. Modified baseline observation carried forward (mBOCF) for participants with missing Week 15 mean pain score.||percentage of participants|||Number
808149|NCT01020474|Secondary|Change From Baseline to Week 15 in Mean Pain Numeric Rating Scale (1 Week Recall Period)|The weekly pain numeric rating scale (Weekly Pain NRS) consists of an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate greater degree of impairment. Participants choose the number that best describes the pain during the last week.|Week 15|The FAS population consists of all randomized participants who received at least one dose of study medication. Baseline observation carried forward (BOCF) for participants with missing Week 15 mean pain score.||Units on a scale||Standard Error|Least Squares Mean
808150|NCT01020474|Secondary|Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS)|Mean sleep quality score was calculated for each week during the double-blind treatment phase (Week 1 to Week 15). A minimum of 4 sleep diaries are required to calculate the mean pain score. The daily quality of sleep diary consists of an 11-point numeric rating scale with which the patient rates the quality of their sleep during the past 24 hours. Zero indicates “best possible sleep” and 10 indicates “worst possible sleep”.|Baseline to Week 15|The FAS population consists of all randomized participants who received at least one dose of study medication.||Units on a scale||Standard Error|Least Squares Mean
808151|NCT01020474|Secondary|Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS)|Mean pain score was calculated for each week during the double-blind treatment phase (Week 1 to Week 15). For each week, only days up to the last day on study medication were considered. A minimum of 4 pain diaries were required to calculate the mean pain score. The pain NRS consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain).|Baseline to Week 15|The FAS population consists of all randomized participants who received at least one dose of study medication.||Units on a scale||Standard Error|Least Squares Mean
808152|NCT01020474|Secondary|Change From Baseline to Week 15 in Mean Sleep Quality Diary Score|Change from Baseline to endpoint in mean sleep quality score from the daily sleep diary, defined as the mean of the last 7 diary entries prior to Visit 10 in the study while the participant is on study medication. The daily quality of sleep diary consists of an 11-point numeric rating scale with which the patient rates the quality of their sleep during the past 24 hours. Zero indicates “best possible sleep” and 10 indicates “worst possible sleep”.|Week 15|The FAS population consists of all randomized participants who received at least one dose of study medication. Last observation carried forward (LOCF) for participants with missing Week 15 mean pain score, i.e., the endpoint mean pain score.||Units on a scale||Standard Error|Least Squares Mean
808153|NCT01020474|Primary|Change From Baseline to Week 15 in Mean Pain Diary Score|The Primary Endpoint is based on the daily pain diary, and is defined as change from baseline to Week 15 in mean pain diary score. The daily pain diary consists of an 11-point numeric rating scale ranging from zero (no pain) to 10 (worst possible pain). The patients rate their pain during the past 24 hours by choosing the appropriate number between 0 (“no pain”) and 10 (“worst possible pain”).|Week 15|The full analysis set (FAS) population consists of all randomized participants who received at least one dose of study medication.||Units on a scale||Standard Error|Least Squares Mean
808154|NCT01020487|Secondary|Part 2: Change From Baseline in First Morning Void (FMV) Urinary Albumin to Creatinine Ratio (UACR)|The mean change from Baseline in FMV UACR on a log scale to each post baseline visit.|Baseline and Weeks 4, 8 and 12|Intent-to-treat dataset with available Baseline data, and available data at each time point||mg/g||Standard Error|Least Squares Mean
808155|NCT01020487|Secondary|Part 2: Percentage of Participants Achieving Final Phosphorus Levels Within KDOQI Target Ranges|"The KDOQI target ranges of serum phosphorus are to maintain at or above age appropriate lower limits and no higher than the age-appropriate upper limits:
Age 6 – 12: 3.6 – 5.8 mg/dL (1.16 – 1.87 mmol/L); Age 13 – 20: 2.3 – 4.5 mg/dL (0.74 – 1.45 mmol/L)."|Week 12|Intent to treat dataset||percentage of participants|||Number
808156|NCT01020487|Secondary|Part 2: Percentage of Participants Achieving Final Calcium Levels Within KDOQI Target Ranges|"KDOQI recommends serum calcium is maintained within age appropriate normal ranges:
Age 6 – 12: 9.4 – 10.2 mg/dL (2.35 – 2.55 mmol/L); Age 13 – 20: 8.8 – 10.2 mg/dL (2.20 – 2.55 mmol/L)."|Week 12|Intent to treat dataset||percentage of participants|||Number
808157|NCT01020487|Secondary|Part 2: Change From Baseline in iPTH to Each Post-baseline Visit||Baseline and Weeks 2, 4, 8 and 12|Intent to treat dataset with available data at each time point||pg/mL||Standard Error|Least Squares Mean
808158|NCT01020487|Secondary|Part 2: Percentage of Participants Achieving a Final iPTH Within KDOQI Target Ranges|"The Kidney Disease Outcomes Quality Initiatives (KDOQI) Pediatric Subcommittee on Practice Guidelines for Bone Metabolism and Disease in Children with CKD target range for intact parathyroid hormone (iPTH) is as follows::
CKD Stage 3: 35 – 69 pg/mL; CKD Stage 4: 70 – 110 pg/mL."|Week 12|Intent to treat dataset||percentage of participants|||Number
808429|NCT01033864|Secondary|Regression Coefficients For Participants Receiving MMF|The estimated regression coefficients for participants who received MMF presented in milligrams per liter (mg/L).|Day 1 at 30 minutes and 1 and 2 hours postdose|PK population. Only participants in the MMF/Prednisone group were assessed for this outcome measure, n=12.||mg/L|||Number
808159|NCT01020487|Primary|Part 2: Percentage of Participants Achieving Two Consecutive Reductions at Least 30% From Baseline in iPTH|The primary efficacy endpoint was the percentage of participants who achieved two consecutive ≥ 30% reductions from baseline in intact parathyroid hormone (iPTH) levels during the 12 week double-blind portion of the study regardless of CKD stage.|12-week double-blind treatment period|The Intent-To-Treat (ITT) Dataset, defined as the set of all randomized participants who took at least one dose of study drug.||percentage of participants|||Number
808160|NCT01020487|Primary|Part 1: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-∞)||Blood samples were collected at hour 0, 1, 2, 4, 6, 8, 12, 24, 36, and 48 hours after dosing.|All participants enrolled and administered paricalcitol for the PK Portion, Part 1||ng*hr/mL||Standard Deviation|Mean
808161|NCT01020487|Primary|Part 1: Paricalcitol Maximum Observed Plasma Concentration (Cmax)||Blood samples were collected at hour 0, 1, 2, 4, 6, 8, 12, 24, 36, and 48 hours after dosing.|All participants enrolled and administered paricalcitol for the pharmacokinetic (PK) period, Part 1||ng/mL||Standard Deviation|Mean
808162|NCT01020526|Primary|Change From Baseline in Pain Numeric Rating Scale by Week|The weekly pain numeric rating scale (Weekly Pain NRS) consists of an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate worse pain. Participants chose the number that best described the pain during the last week. Negative change indicates improvement.|Baseline, Weeks 3, 8, 16, 24 and Last Visit.|This population will include all participants who have received at least one dose of study medication.||Number||Standard Deviation|Mean
808163|NCT01020591|Secondary|The Knee Flexion Active Range of Motion, Balance and Pain (VAS)||Jan 2010 to March 2010||||||
808164|NCT01020591|Primary|Resistive Index (RI)|Ultrasonographic examination provides a non-invasive method to assess blood flow dynamics. The resistive index (RI), calculated from arterial blood flow velocities, reflects vascular resistance. The RI was calculated by dividing the peak systolic velocity (PSV) minus the end-diastolic velocity by the peak systolic velocity, and is cited frequently in the literature for measuring hemodynamics of peripheral vessels.|Participants attended one visit; The outcome measure (RI) was before and after an osteopathic session on the same day; The data collection of the 30 subjects took place between Jan to March 2010; each subject had outcomes measured on one day|||ratio||Standard Deviation|Mean
808165|NCT01020747|Primary|The Primary Activity Variable Was the Recurrence of Recurrent Respiratory Papillomatosis (RRP) in Bevacizumab Treated and the Un-treated Vocal Fold in the Same Patient During and at the End of the 6-month Treatment Period.|Prior to each treatment,the area of reappearance of disease was measured and the % change from baseline was calculated. The change was then added to the % change from the previous treatment to generate a cumulative total % change of reappearance of RRP from baseline. The additive nature of this parameter resulted in % greater than 100% if the area of vocal fold affected by the RRP increased over the baseline measurement.|6 months|All subjects were analyzed.||total percentage change||Standard Deviation|Mean
808166|NCT01020773|Primary|Number of Participants With Successful Extubation, Reintubation and in Hospital Mortality||13 months|||participants|||Number
808167|NCT01020786|Secondary|Percentage of Participants Who Achieve a Complete Response (CR) or a Partial Response (PR) During the Induction Therapy Period|"Calculated as percentage of participants who achieved a CR or PR (confirmed or not). Tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.0, which define when cancer participants improve (respond), stay the same (stabilize), or worsen (progression) during treatments. CR = disappearance of all target lesions. PR = 30% decrease in sum of the longest diameter of target lesions. Progressive Disease (PD) = 20% increase in the sum of longest diameter of target lesions. Stable Disease (SD) = small changes that do not meet above criteria."|Enrollment to date of PD, or end of induction period up to Cycle 4 (21-day cycle)|Full Analysis Set (FAS): consists of the participants who received the induction combination therapy with pemetrexed and carboplatin.||percentage of participants||95% Confidence Interval|Number
808168|NCT01020786|Secondary|Percentage of Participants Who Observe a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) During the Induction Therapy Period|"Calculated as the percentage of participants who achieved a CR, PR, or SD (confirmed or not). Tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.0, which define when cancer participants improve (respond), stay the same (stabilize), or worsen (progression) during treatments. CR = disappearance of all target lesions. PR = 30% decrease in the sum of the longest diameter of target lesions. Progressive Disease (PD) = 20% increase in the sum of the longest diameter of target lesions. SD = small changes that do not meet above criteria."|Enrollment to the date of PD, or end of induction period up to Cycle 4 (21-day cycle)|Full Analysis Set (FAS): consists of the participants who received the induction combination therapy with pemetrexed and carboplatin.||percentage of participants||95% Confidence Interval|Number
808169|NCT01020786|Secondary|Percentage of Participants Who Achieved a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) During the Maintenance Therapy Period|"Percentage of participants who achieved confirmed CR (disappearance of all target lesions), PR (30% decrease in sum of longest diameter of target lesions), or SD (small changes that do not meet above criteria). Response derived from target lesion assessments performed before maintenance therapy (as baseline), during maintenance therapy (as post-baseline), and non-target lesion assessments performed during maintenance therapy according to RECIST guideline version 1.0, defines when cancer participants improve (respond), stay the same (stabilize), or worsen (progression) during treatments."|From the start of maintenance therapy in Cycle 5 (21-day cycle) until the date of measured progressive disease (PD) or death from any cause (up to 18 months)|Analysis set: Maintenance-treated participants, which consist of the participants who received the maintenance therapy with pemetrexed.||percentage of participants||95% Confidence Interval|Number
808178|NCT01020799|Secondary|Hamilton Rating Scale for Depression (HAM-D) Total Score Change From Baseline to Week 4.|HAM-D total score, sum of 17 item scores (each on a 0 to 2 or 0 to 4 scale), assesses the severity of depressive symptoms on a continuous scale from 0 (the best) to 52 (the worst). Change from baseline to Week 4 was calculated as Week 4 value minus baseline value. [observed cases, Mixed Model Repeated Measurement (MMRM), Full Analysis Set (FAS)]|Baseline, Week 4|||scores on a scale||Standard Error|Least Squares Mean
808430|NCT01033864|Primary|Percentage of Participants By Time to Maximum Plasma Concentration (Tmax)||Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours|PK population||percentage of participants|||Number
808170|NCT01020786|Secondary|Overall Survival (OS) During the Maintenance Therapy Period|OS was defined as the duration from the date of the first dose of the maintenance therapy to the date of death from any cause and was calculated by subtracting the induction therapy period from OS. Participants receiving any subsequent systemic anticancer therapy before objective progression or death were censored at date of last objective progression-free disease assessment before starting subsequent systemic anticancer therapy. For participants who were alive, OS was censored at the last contact.|From the start of maintenance therapy in Cycle 5 (21-day cycle) until the date of measured progressive disease (PD) or death from any cause (up to 26.3 months)|Analysis set: Maintenance-treated participants, which consist of the participants who received the maintenance therapy with pemetrexed; 56 participants and 38 participants were censored as the observation period was not enough at the time of data cut-off for the primary endpoint, PFS, and final endpoint, respectively.||months||95% Confidence Interval|Median
808171|NCT01020786|Secondary|Progression Free Survival (PFS) During the Maintenance Therapy Period|"Measured from the date of the first dose of the maintenance therapy. Calculated by subtracting induction therapy period from PFS. Tumor response assessed using Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.0; define when cancer participants improve (respond), stay the same (stabilize), or worsen (progression) during treatments. Participants receiving any subsequent systemic anticancer therapy before objective progression or death were censored at date of last objective progression-free disease assessment before starting subsequent systemic anticancer therapy."|From the start of maintenance therapy in Cycle 5 (21-day cycle) until the date of measured progressive disease (PD) or death from any cause (up to 24.4 months)|Analysis set: Maintenance-treated participants who received maintenance therapy with pemetrexed; 20 and 12 participants were censored at time of primary endpoint (18 months) and final endpoint. They received subsequent systemic anticancer therapy before confirming objective PD or there was not a confirmed objective PD at cut-off.||months||95% Confidence Interval|Median
808172|NCT01020786|Secondary|Percentage of Participants Who Achieved a Complete Response (CR) or Partial Response (PR) During the Induction and Maintenance Therapy Periods|"Calculated as the percentage of participants who achieved a confirmed CR or PR. Tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.0, which define when cancer participants improve (respond), stay the same (stabilize), or worsen (progression) during treatments. CR = disappearance of all target lesions. PR = 30% decrease in the sum of the longest diameter of target lesions. Progressive Disease (PD) = 20% increase in the sum of the longest diameter of target lesions. Stable Disease (SD) = small changes that do not meet above criteria."|Enrollment to date of progressive disease (up to 18 months)|Full Analysis Set (FAS): consists of the participants who received the induction combination therapy with pemetrexed and carboplatin.||percentage of participants|||Number
808173|NCT01020786|Secondary|Percentage of Participants Who Achieve a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) During the Induction and Maintenance Therapy Periods|"Calculated as the percentage of participants who achieved a confirmed CR, PR, or SD. Tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.0, which define when cancer participants improve (respond), stay the same (stabilize), or worsen (progression) during treatments. CR = disappearance of all target lesions. PR = 30% decrease in the sum of the longest diameter of target lesions. Progressive Disease (PD) = 20% increase in the sum of the longest diameter of target lesions. SD = small changes that do not meet above criteria."|Enrollment to date of progressive disease (up to 18 months)|Full Analysis Set (FAS): consists of the participants who received the induction combination therapy with pemetrexed and carboplatin.||percentage of participants||95% Confidence Interval|Number
808174|NCT01020786|Secondary|Overall Survival (OS) During the Induction and Maintenance Therapy Periods|OS was defined as the time from the enrollment date to the date of death from any cause. For participants who were alive, OS was censored at the last contact.|Enrollment to the date of death from any cause (up to 30.8 months)|Full analysis set (FAS): consists of the participants who received the induction combination therapy with pemetrexed and carboplatin; 79 participants were censored as the observation period was not enough at the time of data cut-off for the primary endpoint (EP) of PFS. There were 48 participants censored at the final endpoint data cut-off.||months||95% Confidence Interval|Median
808175|NCT01020786|Primary|Progression Free Survival (PFS) During the Induction and Maintenance Therapy Periods|"PFS defined as time from enrollment date to first date of objective progression of disease or of death from any cause. Tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.0, which define when cancer participants improve (respond), stay the same (stabilize), or worsen (progression) during treatments. Participants receiving any subsequent systemic anticancer therapy before objective progression or death were censored at date of last objective progression-free disease assessment before starting subsequent systemic anticancer therapy."|Enrollment to the date of progressive disease (PD) or the date of death from any cause (up to 18 months)|Full Analysis Set (FAS): consists of the participants who received the induction combination therapy with pemetrexed and carboplatin; 31 participants were censored as they received subsequent systemic anticancer therapy before confirming objective PD or there was not a confirmed objective PD.||months||95% Confidence Interval|Median
808176|NCT01020799|Secondary|Hamilton Rating Scale for Anxiety (HAM-A) Total Score Change From Baseline|HAM-A total score, sum of 14 item scores (each on a 0 to 4 scale), assesses the severity of anxiety symptoms on a continuous scale from 0 (the best) to 52 (the worst). Change from baseline to Week 4 was calculated as Week 4 value minus baseline value. [observed cases, Mixed Model Repeated Measurement (MMRM), Full Analysis Set (FAS)]|Baseline, Week 4|||scores on a scale||Standard Error|Least Squares Mean
808177|NCT01020799|Secondary|Clinical Global Impression - Severity (CGI-S) Score Change From Baseline|CGI-S assesses global illness severity, i.e. the patient’s current clinical state, on a continuous scale from 1 (“Normal, not ill”) to 7 (“Among the most extremely ill patients”). Change from baseline to Week 4 was calculated as Week 4 value minus baseline value. [observed cases, Mixed Model Repeated Measurement (MMRM), Full Analysis Set (FAS)]|Baseline, Week 4|||scores on a scale||Standard Error|Least Squares Mean
808432|NCT01033864|Primary|MPA Area Under the Curve From 0 to 12 Hours (AUC0-12)|The mean MPA AUC0-12 in plasma was determined (in mg multiplied by hours, per Liter [mg*h/L]) from blood samples collected predose and postdose on Day 1.|Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours|PK population||mg*h/L||Standard Deviation|Mean
808179|NCT01020799|Secondary|Montgomery-Åsberg Depression Rating Scale (MADRS) Remission|Number of patients, who achieved MADRS remission at week 4. Remission is defined as a MADRS total score <= 10. MADRS total score, sum of 10 item scores (each on a 0 (best value) to 6 (worst value)scale), assesses the severity of depressive symptoms on a continuous scale from 0 (the best) to 60 (the worst). MADRS remission at Week 4 is calculated using last observation carried forward (LOCF). [Full Analysis Set (FAS)]|Week 4|||Participants|||Number
808180|NCT01020799|Secondary|Montgomery-Åsberg Depression Rating Scale (MADRS) Response|Number of patients with MADRS response at Week 4. MADRS response is defined as >=50% reduction in MADRS total score from baseline. MADRS total score, sum of 10 item scores (each on a 0 (best value) to 6 (worst value)scale), assesses the severity of depressive symptoms on a continuous scale from 0 (the best) to 60 (the worst). MADRS response at Week 4 is calculated using last observation carried forward (LOCF). [Full Analysis Set (FAS)]|Week 4|||Participants|||Number
808181|NCT01020799|Primary|Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score Change From Baseline to Week 4.|MADRS total score, sum of 10 item scores (each on a 0 (best value) to 6 (worst value)scale), assesses the severity of depressive symptoms on a continuous scale from 0 (the best) to 60 (the worst). Change from baseline was calculated as Week 4 value minus baseline value. [observed cases, Mixed Model Repeated Measurement (MMRM), Full Analysis Set (FAS)]|Baseline, Week 4|||scores on a scale||Standard Error|Least Squares Mean
808182|NCT01020812|Secondary|Median Progression Free Survival|Time to progression free survival is defined as the time from randomization until either death or progression of disease. The median survival was calculated using a Kaplan Meier algorithm.|18 months|||months||95% Confidence Interval|Median
808183|NCT01020812|Secondary|To Determine the Overall Survival of TACE and SBRT at 18 Months|Overall survival is defined as the time from the start of treatment until death from any cause.|18 months|All patients who completed treatment||probability|||Number
808184|NCT01020812|Secondary|To Determine the Progression-free Survival of TACE and SBRT at 18 Months|Progression free survival is defined as the time from the start of treatment until the first progression or death. Progression will be defined as either local progression, disease occurring elsewhere in the liver, extrahepatic progression or clinical deterioration attributable to another underlying medical condition in the absence of clear radiographic findings of progressive disease.|18 months|All patients who completed the treatment||survival probability at 18 months|||Number
808185|NCT01020812|Primary|Freedom From Local Progression of TACE and SBRT at 12 Months|Freedom from local progression is defined as the time from start of treatment until the first occurrence of local progression. Local progression is defined as progression in the treated lesion according to the RECIST criteria. Progression outside the treated lesion and/or death will be considered as competing risks. The data was analyzed in a competing risk model with death as a competing risk. The outcome reported is the cumulative incidence at 12 months.|12 months|All patients who completed treatment||proportion of participants||95% Confidence Interval|Number
808186|NCT01020838|Secondary|Subject Level Composite SUVRs by SOT for Baseline and Available Follow-Up Scans|Subject level composite SUVRs (calculated as mean of SUVRs from the frontal, parietal, lateral temporal, anterior and posterior cingulate, and occipital cortices) by SOT are reported for subjects with available brain tissue. The initial drug administration group includes additionally 10 healthy controls who were considered as ß-amyloid negative. The SOTs for deceased subjects were based on Bielschowsky silver staining (SOT 1), Bielschowsky silver staining in combination with immunohistochemistry (SOT 2) and neuropathology assessment according to CERAD (SOT 3). SUVR analysis was performed for baseline and available follow-up scans.|90-110 minutes post injection (PET image acquisition)|||Standardized Uptake Value Ratio (SUVR)||Standard Deviation|Mean
808187|NCT01020838|Secondary|Sensitivity and Specificity of the Subject Level Composite SUVR Calculated Based on Pathology Results.|Sensitivity and specificity of subject level composite Standard Uptake Value Ratios (SUVR) by SOT for subjects with available brain tissue and 10 healthy volunteers. The SUVR were determined as a quantitative measure of tracer uptake. The SUV is defined as the ratio of the tissue radioactivity concentration c (in MBq/kg) at time point t, and the injected activity (in MBq), extrapolated to the same time (t) divided by the body weight (in kg). SUV numbers were then used to derive SUV ratios (SUVR) using the SUV from the cerebellar cortex as reference. SOTs comprised Bielschowsky silver staining (SOT 1), Bielschowsky silver staining with immunohistochemistry (SOT 2) and neuropathology assessment according to CERAD (SOT 3). SUVR analysis was performed for baseline and available follow-up scans. The optimal threshold for the distinction between β-amyloid present yes/no according to the respective SOT was derived based on ROC curve analyses and used to calculate sensitivity and specificity.|90-110 minutes post injection (PET image acquisition)|Sensitivity and Specificity of the subject level Composite SUVR with three different SOTs.||percentage of subjects|||Number
808188|NCT01020838|Secondary|"Sensitivity and Specificity of the Majority Read Whole Brain Visual Assessment in Detecting/Excluding Cerebral Neuritic β-amyloid Plaques Compared With the Histopathological Verification According to CERAD Criteria (SOT 3)."|"Sensitivity and specificity of the whole brain visual assessment were calculated. Any brain with a region classified as abnormal from PET imaging was to be classified as abnormal for the whole brain assessment. This result was derived from assessments by 3 independent readers for a subject where a Standard of Truth (SOT) was available. The SOT for this analysis was based on a histopathological assessment of the presence/absence of β-amyloid according to CERAD Criteria (SOT 3).
The sensitivity was defined as the proportion of brains classified as abnormal from all brains where this SOT was available and was β-amyloid present. The specificity was defined as the proportion of brains classified as normal from all brains where this SOT was available and was β-amyloid not present."|90-110 minutes post injection (PET image acquisition)|"Sensitivity and Specificity of the Majority Read Whole Brain Visual Assessment in Detecting/Excluding Cerebral β-amyloid Plaques Compared with the Histopathological Verification according to CERAD Criteria (SOT 3)."||percentage of subjects||95% Confidence Interval|Number
808197|NCT01020981|Secondary|Depressive Symptoms|The 21-item Beck Depression Inventory-2nd Edition (BDI-II) was used to assess depressive symptoms. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.|Survey was fielded to MIARNG in March 2011 (INARNG in September 2011). Soldiers who did not respond were sent two additional mailings with surveys in April 2011(INANG-October 2011) and May 2011 (INANG-November 2011).|Data were analyzed for those with complete outcome data. Thus, 1 participant in Michigan Army National Guard and 1 participant in Indiana Army National Guard are not included in these results.||units on a BDI-II scale||Standard Deviation|Mean
808189|NCT01020838|Secondary|"Sensitivity and Specificity of the Majority Read Whole Brain Visual Assessment in Detecting/Excluding Cerebral Neuritic β-amyloid Plaques Compared With Histopathological Verification With Bielschowsky Silver Staining and Immunohistochemistry (SOT 2)."|"Sensitivity and specificity of the whole brain visual assessment were calculated. Any brain with a region classified as abnormal from PET imaging was to be classified as abnormal for the whole brain assessment. This result was derived from assessments by 3 independent readers for a subject where a Standard of Truth (SOT) was available. The SOT for this analysis was based on a centralized histopathological assessment of the presence/absence of β-amyloid based on Bielschowsky silver staining and immunohistochemistry (SOT 2).
The sensitivity was defined as the proportion of brains classified as abnormal from all brains where this SOT was available and was β-amyloid present. The specificity was defined as the proportion of brains classified as normal from all brains where this SOT was available and was β-amyloid not present."|90-110 minutes post injection (PET image acquisition)|"Sensitivity and Specificity of the Majority Read Whole Brain Visual Assessment in Detecting/Excluding Cerebral neuritic β-amyloid Plaques Compared with the Histopathological Verification with Bielschowsky silver staining and immunohistochemistry (SOT 2)."||percentage of subjects||95% Confidence Interval|Number
808190|NCT01020838|Secondary|"Sensitivity and Specificity of the Majority Read Whole Brain Visual Assessment in Detecting/Excluding Cerebral Neuritic β-amyloid Plaques Compared With the Histopathological Verification With Bielschowsky Silver Staining (SOT 1)."|"Sensitivity and specificity of the whole brain visual assessment were calculated. Any brain with a region classified as abnormal from PET imaging was to be classified as abnormal for the whole brain assessment. This result was derived from assessments by 3 independent readers for a subject where a Standard of Truth (SOT) was available. The SOT for this analysis was based on a centralized histopathological assessment of the presence/absence of β-amyloid based on Bielschowsky silver staining (SOT 1).
The sensitivity was defined as the proportion of brains classified as abnormal from all brains where this SOT was available and was β-amyloid present. The specificity was defined as the proportion of brains classified as normal from all brains where this SOT was available and was β-amyloid not present."|90-110 minutes post injection (PET image acquisition)|"Sensitivity and Specificity of the Majority Read Whole Brain Visual Assessment in Detecting/Excluding Cerebral β-amyloid Plaques Compared with the Histopathological Verification with Bielschowsky silver staining (SOT 1)."||percentage of subjects||95% Confidence Interval|Number
808191|NCT01020838|Primary|Sensitivity and Specificity of the Majority Read of Visual Assessment of Tracer Uptake Compared to Histological Verification of the Presence or Absence of Cerebral Beta-amyloid in Postmortem Specimens|"The sensitivity/specificity of the visual assessment were calculated based on the majority read assessment of regional tracer uptake. This result was derived from assessments by 3 independent readers for brain regions of a subject where a Standard of Truth (SOT) was available. The SOT for this analysis was a centralized histopathological determination of β-amyloid presence/absence based on both Bielschowsky silver and immunohistochemical staining. Based on the PET images, a brain region was classified as “normal” or “abnormal” depending on the presence or absence of regional tracer uptake in the respective region. “Normal” therefore meant absence of β-amyloid and “abnormal” presence of β-amyloid. Sensitivity was defined as the percentage of abnormal brain regions from all regions where an SOT was available and the SOT was β-amyloid present. Specificity was defined as the percentage of normal brain regions from all regions where an SOT was available and was β-amyloid not present."|90-110 minutes post injection (PET image acquisition)|All participants included in the Interim Analysis Set were included in this analysis.||percentage of regions|||Number
808192|NCT01020877|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 60 hour period.|All participants that completed the study had their samples analyzed. One subject had very low plasma metronidazole levels for Period I samples, therefore the data from this subject was dropped from the statistical analysis.||ng*h/mL||Standard Deviation|Mean
808193|NCT01020877|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 60 hour period.|All participants that completed the study had their samples analyzed. One subject had very low plasma metronidazole levels for Period I samples, therefore the data from this subject was dropped from the statistical analysis.||ng*h/mL||Standard Deviation|Mean
808194|NCT01020877|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Cmax.|Blood samples collected over a 60 hour period.|All participants that completed the study had their samples analyzed. One subject had very low plasma metronidazole levels for Period I samples, therefore the data from this subject was dropped from the statistical analysis.||ng/mL||Standard Deviation|Mean
808195|NCT01020903|Primary|Post-operative Nausea and Vomiting|Records for this study are no longer available to the sponsor to update this study record as they were destroyed in Hurricane Sandy in October 2012. This information was provided to FDA and OHRP when the event occurred in 2012. Thus, we do not have any information to use to update the records. In addition, the PI for this study is no longer with the institution and no contact information is available.|1 year|"Records for this study are no longer available as they were destroyed in Hurricane Sandy in 10/2012- we do not have any information to use to update the records. The PI for this study is no longer with the institution and no contact information is available. Since we cannot verify the # of participants analyzed, the numbers were changed to 0."|||||
808196|NCT01020981|Secondary|PTSD Symptoms|"The PCL is a 17-item self-report checklist of PTSD symptoms based closely on the DSM-IV criteria. The PCL-M is a military version and questions refer to a stressful military experience. Total possible scores range from 17 to 85. Higher scores indicate more symptoms of PTSD and a cut-off score of 50 is used for indicating a probable diagnosis of combat-related PTSD."|Survey was fielded to MIARNG in March 2011 (INARNG in September 2011). Soldiers who did not respond were sent two additional mailings with surveys in April 2011(INANG-October 2011) and May 2011 (INANG-November 2011).|86% of MI NG soldiers who completed surveys returned a complete PCL scale and 87% of IN NG soldiers who completed surveys returned a complete PCL scale.||units on PCL scale||Standard Deviation|Mean
808462|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 4: Less Worried About Having Unprotected Sex Due to the Availability of PrEP|Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: “The availability of PrEP makes me less worried about having unprotected sex.”|Week 4|Not all participants answered every question||percentage of participants|||Number
808198|NCT01020981|Primary|Feasibility-response Rate|Response rate of Soldiers to a mailed survey.|Survey was fielded to Michigan National Guard Service Members on three occasions, March 2011, April 2011, and May 2011. The survey was also fielded to Indiana National Guard Service Members on September 2011, October 2011, and November 2011.|"8 or 5% of surveys to Michigan NG Soldiers were not deliverable. 32 (21%) of Indiana NG soldier surveys were not deliverable.
66 of 142 delivered surveys to MI soldiers were returned for a response rate of 46%. 60 of 118 deliverable surveys to Indiana NG Soldiers were returned for a response rate of 51%."||% of Soldiers returning mailed survey|||Number
808199|NCT01021007|Primary|Plaque Index (Quigley-Hein Score)|Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|6 weeks|||Units on a scale||Standard Deviation|Mean
808200|NCT01021007|Primary|EIBI Bleeding Score: Eastman Indterdental Bleeding Index Scale|0 = no bleeding or 1=spontaneous bleeding. Both upper and lower gums around each tooth in the mouth are checked for bleeding sites . The total number of 0 & 1 scores are added together and then divided by the total number of sites in the mouth evaluated to give the average number of bleeding sites in the mouth.|6 weeks|||bleeding sites||Standard Deviation|Mean
808201|NCT01021007|Primary|Gingival Index|1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding|6 weeks|||Units on a scale||Standard Deviation|Mean
808202|NCT01021020|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable colchicine plasma concentration to the elimination rate constant.|serial pharmacokinetic blood samples collected pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose|Colchicine(fasted)-could not be determined for Subject 25. Colchicine(high-fat meal)-could not be determined for Subjects 22,25, and 28. Colchicine/Probenecid(fasted)-could not be determined for Subject 25.||pg-hr/mL||Standard Deviation|Mean
808203|NCT01021020|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable colchicine concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic blood samples collected pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose|||pg-hr/mL||Standard Deviation|Mean
808204|NCT01021020|Primary|Maximal Plasma Concentration (Cmax)|The maximum or peak concentration that colchicine reaches in the plasma.|serial pharmacokinetic blood samples collected pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose|||pg/mL||Standard Deviation|Mean
808205|NCT01021111|Secondary|Thigh Coronal Angular Velocity After Feedback Training|How fast the thigh is moving relative to the tibia during the activity, measured in degrees/second.|1 day|||degrees/second||Standard Deviation|Mean
808206|NCT01021111|Primary|Knee Flexion Angle and Trunk Flexion Angle After Activity Training With Feedback|Knee flexion angle describes the angle between the tibia and femur during the activity. Trunk flexion is the angle between the shoulders and the hips during the activity.|1 day|||degrees||Standard Deviation|Mean
808207|NCT01021215|Secondary|Proportion of Cases With a Post-treatment Increase in Urinary PGE-M Levels|Proportion of cases with a post-treatment increase in urinary PGE-M levels by comparing those treated with Zileuton and Celecoxib combined therapy compared to those treated with Zileuton alone. Pre/postchange in levels (Increase) derived from baseline level to Day 6 +/- 1 day. Differences in baseline levels between 2 treatment arms were examined using the Wilcoxon rank-sum test.|Baseline to Day 6|Analysis includes only number of participants in each treatment arm with post-treatment increase in urinary PGE-M levels as measured from baseline.||proportion of participants|||Number
808208|NCT01021215|Primary|Median Urinary LTE4 Levels (Pre and Post Treatment)|Pre and Post treatment differences in urinary LTE4 levels measured in each treatment arm compared using paired t-test should the data conform to the normality assumption or one-sample Wilcoxon rank-sum test. LTE4 levels reported as median with full range (pg/mg creatinine) for Pre treatment versus Post treatment LTE4 levels among study participants compliant to treatment with evaluable urine samples at both time points (baseline and Day 6 +/- 1 day).|Baseline and day 6|Seventy-seven subjects completed the entire study, three withdrew for personal reasons. Seven of those participants were excluded from analysis as non-compliant (study medications were undetectable).||pg/mg creatinine||Full Range|Median
808209|NCT01021215|Primary|Median Urinary PGE-M Levels (Pre and Post Treatment)|Pre and Post treatment differences in urinary PGE-M levels measured in each treatment arm. PGE-M levels reported as median with full range (ng/mg creatinine) for Pre treatment versus Post treatment PGE-M levels among study participants compliant to treatment with evaluable urine samples at both time points (baseline and Day 6 +/- 1 day).|Baseline and Day 6|Seventy-seven subjects completed the entire study with seven of those excluded from analysis as non-compliant (study medications were undetectable). Urine of two participants contained interfering substances thus were excluded from PGE-M related analysis.||ng/mg creatinine||Full Range|Median
808210|NCT01021293|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity.|During the entire study period (from Day 0 to Month 3)|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.||Participants|||Count of Participants
808211|NCT01021293|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within the 31-day (Days 0-30) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.||Participants|||Count of Participants
808212|NCT01021293|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, gastrointestinal symptoms, irritability/fussiness, loss of appetite and fever [defined as axillary temperature higher than (>) 37.0°C degrees Celsius]. Gastrointestinal symptoms included nausea, vomiting, diarrhoea and/or abdominal pain. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = subject did not eat at all. Grade 3 gastrointestinal symptoms = gastrointestinal symptoms that prevented normal activity. Grade 3 fever= temperature > 39°C. Related = symptom assessed by the investigator as causally related to the vaccination.|During the 4-day (Days 0–3) post-vaccination period following each vaccine dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented, who had filled in their symptom sheets.||Participants|||Count of Participants
808213|NCT01021293|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site. This outcome measure concerns subjects from the Poliorix Group only.|During the 4-day (Days 0–3) post-vaccination period following each vaccine dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented, who had filled in their symptom sheets.||Participants|||Count of Participants
808214|NCT01021293|Secondary|Anti-poliovirus Types 1, 2 and 3 Antibody Titers|Antibody titers were presented as geometric mean titers (GMTs).|Prior to the first vaccine dose (Day 0) and one month after the third vaccine dose (Month 3)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.||Titers||95% Confidence Interval|Geometric Mean
808215|NCT01021293|Secondary|Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3|A seroprotected subject was defined as a vaccinated subject with anti-poliovirus types 1, 2 and 3 titers ≥ 8 ED50.|At Day 0, prior to the first vaccine dose|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.||Participants|||Count of Participants
808216|NCT01021293|Primary|Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3|A seroprotected subject was defined as a vaccinated subject with anti-polio types 1, 2 and 3 titers greater than or equal to (≥) 8 effective dose 50 (ED50).|At Month 3, one month after the third vaccine dose|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.||Participants|||Count of Participants
808217|NCT01021306|Secondary|Bothersomeness of Symptoms|Possible ratings range from 1 (not at all bothersome) to 5 (extremely bothersome)|2 months|||units on a scale||95% Confidence Interval|Mean
808218|NCT01021306|Secondary|Oral Health Impact Profile (OHIP-14)|The OHIP-14 contains 2 questions about each of 7 dimensions (14 items), indicating how often the participant had experienced each difficulty in the previous month; possible responses range from 0 (never) to 4 (very often). The OHIP score was obtained by summing the 14 ratings.|2 months|||units on a scale||95% Confidence Interval|Mean
808219|NCT01021306|Primary|Patient-Rated TMD Pain, an 11 Point Numerical Rating Scale (NRS)|The Numerical Rating Scale ranges from 0 (no pain) to 10 (pain as bad as it can be).|2 months|||units on a scale||95% Confidence Interval|Mean
808220|NCT01021332|Secondary|Change From Baseline to End of Treatment in EQ-5D Visual Analogue Scale (VAS) Score|Visual Analogue Scale (VAS) is part of the EQ-5D questionnaire. The VAS is self-rated by the participant ranging from 0 to 100 (worst imaginable health state to best imaginable health state).|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used||units on a scale||Standard Deviation|Mean
808221|NCT01021332|Secondary|Change From Baseline to End of Treatment in EQ-5D Anxiety/Depression Score|"The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:
mobility
self-care
usual activity
pain/discomfort
anxiety/depression
Each domain has 3 response levels (1= not anxious, 2= moderately anxious, 3 = extremely anxious)."|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used||participants|||Number
808222|NCT01021332|Secondary|Change From Baseline to End of Treatment in EQ-5D Pain/Discomfort Score|"The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:
mobility
self-care
usual activity
pain/discomfort
anxiety/depression
Each domain has 3 response levels (1= no pain, 2= moderate pain, 3 = extreme pain)."|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used||participants|||Number
808223|NCT01021332|Secondary|Change From Baseline to End of Treatment in EQ-5D Usual Activities Score|"The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:
mobility
self-care
usual activity
pain/discomfort
anxiety/depression
Each domain has 3 response levels (1= no problem, 2= some problems, 3 = unable to perform usual activities)."|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used||participants|||Number
808487|NCT01033942|Primary|Frequency of Missing Study Pills Because Participant Didn't Think it Was Needed Because he/She Was Not Engaged in Risky Sex||24 weeks|Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.||% of participants in each category|||Number
808224|NCT01021332|Secondary|Change From Baseline to End of Treatment in EQ-5D Self-care Score|"The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:
mobility
self-care
usual activity
pain/discomfort
anxiety/depression
Each domain has 3 response levels (1= no problem, 2= some problems, 3 = unable to wash/dress)."|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used||participants|||Number
808225|NCT01021332|Secondary|Change From Baseline to End of Treatment in EQ-5D Mobility Score|"The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:
mobility
self-care
usual activity
pain/discomfort
anxiety/depression
Each domain has 3 response levels (1= no problem, 2= some problems, 3 = confined to bed)."|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used||participants|||Number
808226|NCT01021332|Secondary|Number of OAB-q Responders Based on Health-related Quality of Life: Total Score|A OAB-q responder was defined as a participant with an improvement from baseline in HRQoL subscale total score ≥ 10.|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used||percentage of participants|||Number
808227|NCT01021332|Secondary|Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Total Score|"The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6:
coping
concern
sleep
social interaction
Total score is calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement."|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used||units on a scale||Standard Deviation|Mean
808228|NCT01021332|Secondary|Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Social Score|"The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6:
coping
concern
sleep
social interaction
Social score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement."|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used||units on a scale||Standard Deviation|Mean
808229|NCT01021332|Secondary|Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Sleep Score|"The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6:
coping
concern
sleep
social interaction
Sleep score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement."|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used||units on a scale||Standard Deviation|Mean
808230|NCT01021332|Secondary|Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Concern Score|"The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6:
coping
concern
sleep
social interaction
Concern score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement."|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used||units on a scale||Standard Deviation|Mean
808231|NCT01021332|Secondary|Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Coping Score|"The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6:
coping
concern
sleep
social interaction
Coping score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement."|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used||units on a scale||Standard Deviation|Mean
808232|NCT01021332|Secondary|Change From Baseline to End of Treatment in Symptom Bother Score|The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The Symptom Bother portion consists of an 8-item scale scored from 1 to 6.The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from baseline indicates an improvement.|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used||units on a scale||Standard Deviation|Mean
808244|NCT01021332|Secondary|Change From Baseline to End of Treatment in Mean Voided Volume Per Micturition|A micturition is any voluntary urination, excluding episodes of incontinence only. The mean volume voided per micturition was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment. LOCF imputation was used.||ml||Standard Deviation|Mean
808233|NCT01021332|Secondary|Change From Baseline to End of Treatment in Individual IPSS Scores|"The IPSS is a validated global questionnaire to assess the degree of urinary symptoms, based on answers to 7 questions concerning urinary symptoms:
Incomplete emptying of the bladder
Intermittency
Weak stream
Hesitancy
Frequency
Urgency
Nocturia
Each question is assigned points from 0 to 5 indicating increasing severity of the symptom."|Baseline and up to 52 weeks of FDC treatment|A total of 5 subjects has been excluded from the FAS analysis due to invalid questionnaires. LOCF imputation was used.||units on a scale||Standard Deviation|Mean
808234|NCT01021332|Secondary|Change From Baseline to End of Treatment in IPSS Quality of Life (QoL) Score|The QoL assessment was a single question asking the participant how he would feel about tolerating his current level of symptoms for the rest of his life. The answers ranged from 0 to 6 (delighted to terrible).|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used||units on a scale||Standard Deviation|Mean
808235|NCT01021332|Secondary|Change From Baseline to End of Treatment in IPSS Storage Score|The IPSS is a validated global questionnaire to assess the degree of urinary symptoms based on answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The storage symptom score is the sum of the responses to 3 storage questions (frequency,urgency and nocturia) and ranges from 0 to 15 (mildly symptomatic to severely symptomatic).|Baseline and up to 52 weeks of FDC treatment|A total of 5 subjects has been excluded from the FAS analysis due to invalid questionnaires. LOCF imputation was used.||units on a scale||Standard Deviation|Mean
808236|NCT01021332|Secondary|Change From Baseline to End of Treatment in IPSS Voiding Score|The IPSS is a validated global questionnaire to assess the degree of urinary symptoms based on answers to 7 questions. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The voiding score is the sum of the responses to 4 voiding questions (incomplete emptying of the bladder, intermittency, weak stream, hesitancy) and ranges from 0 to 20 (mildly symptomatic to severely symptomatic).|Baseline and up to 52 weeks of FDC treatment|A total of 5 subjects has been excluded from the FAS analysis due to invalid questionnaires. LOCF imputation was used.||units on a scale||Standard Deviation|Mean
808237|NCT01021332|Primary|Change From Baseline to End of Treatment in Total Urgency Frequency Score (TUFS) (Previously Known as Total Urgency Score [TUS])|"The Patient Perception of the Intensity of Urgency Scale (PPIUS) is a validated scale completed as part of the micturition diary. For each micturition and/or incontinence episode, the participant rated the degree of associated urgency according to the following 5-point categorical scale:
0. No urgency;
1. Mild urgency;
2. Moderate urgency;
3. Severe urgency;
4. Urgency incontinence TUS/TUFS was calculated as the sum of the PPIUS gradings from the 3-day diary divided by the number of days on which urgency grading was recorded. Higher scores indicate more severe urgency."|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment. LOCF imputation was used.||units on a scale||Standard Deviation|Mean
808238|NCT01021332|Secondary|Change From Baseline to End of Treatment in Mean Number of Pads Used Per 24 Hours|The mean number of pads per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.|Baseline and up to 52 weeks of FDC treatment|FAS population and at least 1 use of a pad at baseline. LOCF imputation was used.||pads||Standard Deviation|Mean
808239|NCT01021332|Secondary|Change From Baseline to End of Treatment in Mean Number of Nocturia Episodes Per 24 Hours|A nocturia episode is defined as waking up at night to void (i.e., any voiding associated with sleep disturbance between the time the participant goes to bed with the intention to sleep until the time the patient gets up in the morning with the intention to stay awake). The mean number of nocturia episodes per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.|Baseline and up to 52 weeks of FDC treatment|FAS population and at least 1 nocturia episode at baseline. LOCF imputation was used.||nocturia episodes||Standard Deviation|Mean
808240|NCT01021332|Secondary|Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours|An incontinence episode is defined as an episode with any involuntary loss of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.|Baseline and up to 52 weeks of FDC treatment|FAS population and at least 1 incontinence episode at baseline. LOCF imputation was used.||incontinence episodes||Standard Deviation|Mean
808241|NCT01021332|Secondary|Change From Baseline to End of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours|An urgency incontinence episode is defined as an episode with any involuntary leakage of urine accompanied by or immediately preceded by urgency. The mean number of urgency incontinence episodes with PPIUS grade 3 (Severe incontinence) or 4 (Urgency incontinence) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.|Baseline and up to 52 weeks of FDC treatment|FAS population and at least 1 urgency incontinence episode at baseline. LOCF imputation was used.||urgency incontinence episodes||Standard Deviation|Mean
808242|NCT01021332|Secondary|Change From Baseline to End of Treatment in Mean Number of Urgency Episodes (PPIUS Grade 3 or 4) Per 24 Hours|An urgency episode is defined as an episode of strong desire to void accompanied by fear of leakage or pain. The mean number of urgency episodes with PPIUS grade 3 (Severe urgency) or 4 (Urgency incontinence) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.|Baseline and up to 52 weeks of FDC treatment|FAS population with at least 1 urgency episode at baseline. LOCF imputation was used.||urgency episodes||Standard Deviation|Mean
808243|NCT01021332|Secondary|Change From Baseline to End of Treatment in Maximum Volume Voided Per Micturition|A micturition is any voluntary urination, excluding episodes of incontinence only. The maximum volume voided per micturition was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment. LOCF imputation was used.||ml||Standard Deviation|Mean
808463|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 24: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex|Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: “I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex.”|Week 24|Not all participants answered every question||percentage of participants|||Number
808245|NCT01021332|Secondary|Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours|A micturition is any voluntary urination, excluding episodes of incontinence only.The mean number of micturitions per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment. LOCF imputation was used.||micturitions||Standard Deviation|Mean
808246|NCT01021332|Primary|Change From Baseline to End of Treatment in Total International Prostate Symptom Score (IPSS)|"The International Prostate Symptom Score (IPSS) is a validated global questionnaire to assess the degree of urinary symptoms, based on answers to 7 questions concerning urinary symptoms:
Incomplete emptying of the bladder
Intermittency
Weak stream
Hesitancy
Frequency
Urgency
Nocturia Each question is assigned points from 0 to 5 indicating increasing severity of the symptom. Total score can range from 0 to 35 (mildly symptomatic to severely symptomatic)."|Baseline and up to 52 weeks of FDC treatment|Full Analysis Set (FAS)-participants who took at least 1 dose of the FDC during the open-label study, had a total IPSS or TUS at baseline and had at least one total IPSS or TUS after first dose of the FDC in Study 905-CL-057. Excluded 5 participants with invalid questionnaires. Last Observation Carried Forward (LOCF) imputation was used.||units on a scale||Standard Deviation|Mean
808247|NCT01021332|Primary|Change From Baseline to End of Treatment in Average Flow Rate (Qmean)|Qmean during a micturition (urination) was recorded using uroflowmetry.|Baseline and up to 52 weeks of FDC treatment|SAF population with at least one baseline and one post-baseline micturition episode.||ml/s||Standard Deviation|Mean
808248|NCT01021332|Primary|Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax)|Qmax during a micturition (urination) was recorded using uroflowmetry.|Baseline and up to 52 weeks of FDC treatment|SAF population with at least one baseine and one post-baseline micturition episode.||ml/s||Standard Deviation|Mean
808249|NCT01021332|Primary|Change From Baseline to End of Treatment in Post Void Residual (PVR) Volume|PVR volume is the volume of urine retained after voiding. PVR volume was assessed by ultrasonography or bladder scan.|Baseline and up to 52 weeks of FDC treatment|SAF population with at least one baseline and one post-baseline PVR volume measured.||ml||Standard Deviation|Mean
808250|NCT01021332|Primary|Number of Participants With Adverse Events (AEs)|Safety is monitored by collecting AEs, which include abnormal lab parameters, vital signs or ECG data if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study drug or was clinically significant. A serious AE (SAE) was an AE resulting in death, persistent or significant disability/incapacity or congenital anomaly/birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important. AEs were assessed by the Investigator for intensity (mild-no disruption of normal daily activities, moderate-affected normal daily activities or severe-inability to perform daily activities) and for causal relationship to study drug. A treatment-emergent adverse event (TEAE) was defined as an AE that occurred after the intake of first dose of double-blind study drug (if on FDC in 905-CL-055) or after first open-label dose until 30 days after the last dose of open-label study drug (in 905-CL-057).|From first dose of double-blind study drug (if on FDC in 905-CL-055) or first open-label dose up to 30 days after last dose of open-label study drug (in 905-CL-057) (up to 56 weeks)|Safety analysis set-participants who received at least 1 dose of the FDC tamsulosin/solifenacin 0.4 mg/6 mg or 0.4 mg/9 mg during the open-label treatment period and had any data reported after the first dose of the FDC during the open-label treatment period||participants|||Number
808251|NCT01021423|Secondary|Participants With a Tumor Response|"Number of participants with a measurable tumor at time of randomization who achieve a response. Complete response (CR) is defined as the complete disappearance of all detectable clinical and radiographic evidence of disease and the disappearance of all disease-related symptoms if present before therapy. Partial response (PR) is defined as the regression of measurable disease and no appearance of new sites of disease. For full definitions, please refer to the 2007 Revised Response Criteria for Malignant Lymphoma (Cheson 2007).
Study terminated prematurely. Analysis not conducted."|up to 7 years|Study terminated prematurely. Analysis not conducted.||participants|||Number
808252|NCT01021423|Secondary|Time to Treatment Failure|Time to treatment failure was defined as the time from randomization until the date at which a participant was removed from treatment due to progression, toxicity, refusal or death or received another Non-Hodgkin Lymphoma (NHL) therapy, whichever occurs first.|up to 2 years|Study terminated prematurely. Analysis not conducted.||months||95% Confidence Interval|Median
808253|NCT01021423|Secondary|Time to Progression|"Time to progression was defined as the time from the date of randomization until the first date of documented disease progression.
Study terminated prematurely. Analysis not conducted."|up to 7 years|Study terminated prematurely. Analysis not conducted.||months||95% Confidence Interval|Median
808254|NCT01021423|Secondary|Participants With Treatment Emergent Adverse Events (TEAEs)|"Participants with treatment-emergent adverse events (TEAEs) during the treatment period plus 30 days. A participant with multiple occurrences of an adverse event within a category is counted only once in that category. Adverse events were evaluated by the investigator.
The National Cancer Institute (NCI)'s Common Toxicity Criteria for AEs (NCI CTC) was used to grade AE severity. Severity grade 3= severe and undesirable AE. Severity grade 4= life-threatening or disabling AE."|up to 9 months|Safety population of participants who received at least one dose of study drug||participants|||Number
808255|NCT01021423|Secondary|Overall Survival|"Overall survival was defined as the time from randomization to death from any cause.
Study terminated prematurely. Analysis not conducted."|up to 7 years|Study terminated prematurely. Analysis not performed.||months||95% Confidence Interval|Median
808256|NCT01021423|Primary|Progression-free Survival (PFS)|"PFS is defined as the time from randomization into the study to the first observation of disease progression or death due to any cause. Progression, as defined by the 2007 Revised Response Criteria for Malignant Lymphoma (Cheson, 2007), is any new lesion or increase by 50% of previously involved sites from nadir.
Study terminated prematurely. Analysis not conducted."|up to 7 years|Study terminated prematurely. Analysis not performed.||months||95% Confidence Interval|Median
808257|NCT01021553|Secondary|Number of Participants With Dose/Exposure Response Relationship Using PK/Pharmacodynamics (PD) Modeling|The relationship between plasma concentrations of GSK557296 and selected endpoints were planned to be explored using appropriate PK/PD models.|Up to Week 8|ITT Population. Data was not collected for this outcome measure.|||||
822021|NCT01152385|Secondary|Number of Responders in Terms of HbA1C ≤ 6.5%||at 4th month|The analysis population was prior to rescue treatment (FAS)||Participants|||Number
808258|NCT01021553|Secondary|Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment. On-treatment adverse events were those started on or after the first dose of study medication and on or before the last dose of study medication.|Baseline and up to follow up (post treatment 48 hours)|Safety Population.||Participants|||Number
808259|NCT01021553|Secondary|Number of Participants With Shift From Baseline in Additional Lab Parameters (Free T3, Prostate Specific Antigen [PSA], Thyroid Stimulating Hormone [TSH] and Total Testosterone)|Baseline laboratory values were the latest values obtained on or before the participant’s Baseline reference date. Unscheduled laboratory values were summarized as at-visit values only in the event that an at-visit laboratory value was missing. The values were presented as high, low or normal values shifted from Baseline value.|Baseline and up to follow up (post treatment 48 hours)|Safety Population. Only those participants available at the specified time points were analyzed.||Participants|||Number
808260|NCT01021553|Secondary|Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry)|Serum laboratory parameters: Albumin, Alkaline phosphatase (AP), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Direct bilirubin, Total Bilirubin (T. Bilirubin), Calcium, Chloride, Carbon dioxide content/Bicarbonate (CO2/HCO3), Creatinine, Gamma glutamyl transferase (GGT), Glucose, Potassium, Sodium, Total protein (T. Protein), Urea/Blood urea nitrogen (BUN) and Uric acid were assessed. Baseline laboratory values were the latest values obtained on or before the participant’s Baseline reference date. Unscheduled laboratory values were summarized as at-visit values only in the event that an at-visit laboratory value was missing. The values were presented as high, low or normal values shifted from Baseline value.|Baseline and up to follow up (post treatment 48 hours)|Safety Population. Only those participants available at the specified time points were analyzed.||Participants|||Number
808261|NCT01021553|Secondary|Mean Change From Baseline in Electrocardiogram (ECG) Values|ECG parameter values for QT interval, QT duration corrected for heart rate by Fridericia’s formula (QTc [Fridericia]), QT duration corrected for heart rate by Bazett’s formula (QTc [Bazett]), PR Interval and QRS Duration were assessed. The Baseline ECG was the latest ECG recorded on or before the participant’s Baseline reference date. Change from Baseline was the value at any visit post-Baseline minus value at Baseline.|Baseline and up to follow up (post treatment 48 hours)|Safety Population. Only those participants available at the specified time points were analyzed.||Milliseconds||Standard Deviation|Mean
808262|NCT01021553|Secondary|Mean Change From Baseline in Heart Rate|Heart rate assessment was done in a seated position. If the single measure was outside the cut off value, the mean of three seated measures were taken approximately 5-10 minutes apart was recorded. Baseline value was the latest values obtained on or before the Baseline reference date. Change from Baseline was the value at any visit post-Baseline minus value at Baseline. Per-participant values for all vital sign measures were taken as the mean of all reported values on a given date, regardless of recorded position.|Baseline and up to follow up (post treatment 48 hours)|Safety Population. Only those participants available at the specified time points were analyzed.||Beats per minute||Standard Deviation|Mean
808263|NCT01021553|Secondary|Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|SBP and DBP were taken in a seated position. If the single measure was outside the cut off value, the mean of three seated measures were taken approximately 5-10 minutes apart was recorded. Baseline value was the latest values obtained on or before the Baseline reference date. Change from Baseline was the value at any visit post-Baseline minus value at Baseline. Per-participant values for all vital sign measures were taken as the mean of all reported values on a given date, regardless of recorded position.|Baseline and up to follow up (post treatment 48 hours)|The Safety Population consisted of all participants randomized to study treatment who received at least one dose of study drug. Only those participants available at the specified time points were analyzed.||Millimeters of mercury||Standard Deviation|Mean
808264|NCT01021553|Secondary|Time of Occurrence of Maximum Observed Plasma Concentration (Tmax) of GSK557296|The PK visit was not needed to take place at visit 2 but supposed to be completed before visit 3. The participants were asked to fast overnight prior to their PK sampling day and the time of their last meal was recorded.|At 0, 0.25, 0.5, 0.75, 1, 2, 4, 6 and 8 hours at visit 2 or within 7 days of randomization|PK Population. Only those participants with data available at the indicated time points were analyzed.||hours||Geometric Coefficient of Variation|Geometric Mean
808265|NCT01021553|Secondary|Maximum Observed Plasma Concentration (Cmax) of GSK557296|The PK visit was not needed to take place at visit 2 but supposed to be completed before visit 3. The participants were asked to fast overnight prior to their PK sampling day and the time of their last meal was recorded.|At 0, 0.25, 0.5, 0.75, 1, 2, 4, 6 and 8 hours at visit 2 or within 7 days of randomization|PK Population. Only those participants with data available at the indicated time points were analyzed.||Nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
808266|NCT01021553|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time [AUC(0-inf)] and From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration [AUC(0-t)] of GSK557296|The pharmacokinetic (PK ) visit was not needed to take place at visit 2 but supposed to be completed before visit 3. The participants were asked to fast overnight prior to their PK sampling day and the time of their last meal was recorded.|At 0, 0.25, 0.5, 0.75, 1, 2, 4, 6 and 8 hours at visit 2 or within 7 days of randomization|PK Population consisted of all participants from whom a PK sample had been obtained and analyzed. Only those participants with data available at the indicated time points were analyzed.||Hours times nanograms per milliliters||Geometric Coefficient of Variation|Geometric Mean
808274|NCT01021683|Secondary|Plasma Concentration of Itraconazole by Breakthrough Fungal Infection|Plasma level of itraconazole was defined as the sum of IC and HIC. A breakthrough fungal infection was defined as any fungal infection that was diagnosed more than (>) 3 days on or during therapy or within 7 days after completion of therapy. Blood cultures were assessed to identify fungus.|Day 5|The ITT population included the participants who satisfied the eligibility criteria, received the study drug at least once, and in whom the primary efficacy endpoint was measured at least once. Here, 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for given category.||ng/mL||Standard Deviation|Mean
808267|NCT01021553|Secondary|Mean Change From Baseline in IELT Compared After the First Dose of Study Drug or Placebo|Male participants needed to make a minimum of 4 attempts at SI and Baseline IELTs were assessed by stop watch measurements for each SI attempt. IELT was the elapsed time from vaginal penetration until ejaculation. First dose IELT was the IELT value associated with the first valid SI attempt made during the treatment period. Baseline IELT was calculated as the arithmetic mean IELT from valid screening SI attempts. If multiple screening SI attempts were made on the same calendar day, only the IELT from the first attempt was used in the calculation of Baseline IELT. Change from Baseline IELT was calculated by subtracting the Baseline IELT (arithmetic mean IELT from valid screening attempts) from the on-treatment IELT (median IELT from valid on-treatment attempts). Only participant with a Baseline IELT and a valid first attempt were included.|Baseline and Week 4|ITT Population. Only those participants with data available at the indicated time points were analyzed.||minutes||Standard Deviation|Mean
808268|NCT01021553|Secondary|Mean Change From Baseline in IELT Compared After Each 4-week Treatment Period and Over All 8 Weeks or Until Premature Discontinuation|Male participants needed to make a minimum of 4 attempts at SI and Baseline IELTs were assessed by stop watch measurements for each SI attempt. IELT was the elapsed time from vaginal penetration until ejaculation. Baseline IELT was calculated as the arithmetic mean IELT from valid screening SI attempts. If multiple screening SI attempts were made on the same calendar day, only the IELT from the first attempt was used in the calculation of Baseline IELT. Change from Baseline IELT was calculated by subtracting the Baseline IELT (arithmetic mean IELT from valid screening attempts) from the on-treatment IELT (median IELT from valid on-treatment attempts). Only participants with a Baseline and a post-Baseline IELT value were included.|Baseline and up to Week 8|ITT Population. Only those participants available at the specified time points were analyzed.||minutes||Standard Deviation|Mean
808269|NCT01021553|Secondary|Mean IELT Compared After the First Dose of Study Drug or Placebo|Male participants needed to make a minimum of 4 attempts at SI and Baseline IELTs were assessed by stop watch measurements for each SI attempt. IELT was the elapsed time from vaginal penetration until ejaculation. First dose IELT was the IELT value associated with the first valid SI attempt made during the treatment period. For GSK557296 50 mg and 150 mg: LS mean values and two-sided p-values are from the general linear model ln(median IELT)= ln(Baseline IELT) + treatment + cluster using placebo, GSK557296 50 mg and GSK557296 150 mg treatments. A step-down procedure was used to determine if the efficacy of on-demand GSK557296 was superior to placebo. First, the average of the geometric mean IELTs of the pooled 150mg and 50mg doses of GSK557296 was tested against placebo, and if significance was achieved with this global plateau trend test (p < 0.05), then the simultaneous pair wise comparisons of the 150mg and 50mg doses to placebo would occur (each at an alpha level of 0.05).|Up to Week 8|ITT Population. Only those participants with data available at the indicated time points were analyzed.||minutes||Standard Error|Geometric Mean
808270|NCT01021553|Secondary|Mean IELT Compared After Each 4-week Treatment Period, or Until Premature Discontinuation|Male participant needed to make a minimum of 4 attempts at SI and Baseline IELTs were assessed by stop watch measurements for each SI attempt. IELT was the elapsed time from vaginal penetration until ejaculation. On-treatment IELT for each participant was calculated by taking the median IELT from all valid on-treatment IELT attempts. Geometric mean IELT for each treatment was compared using analysis of covariance (ANCOVA). LS mean values and two-sided p-values are from the general linear model ln(median IELT)= ln(Baseline IELT) + treatment + cluster. A step-down procedure was used to determine if the efficacy of on-demand GSK557296 was superior to placebo. First, the average of the geometric mean IELTs of the pooled 150mg and 50mg doses of GSK557296 was tested against placebo, and if significance was achieved with this global plateau trend test (p < 0.05), then the simultaneous pair wise comparisons of the 150mg and 50mg doses to placebo would occur (each at an alpha level of 0.05).|Up to Week 8|ITT Population. Only those participants available at the specified time points were analyzed.||minutes||Standard Error|Geometric Mean
808271|NCT01021553|Primary|Mean Intravaginal Ejaculatory Latency Time (IELT) Compared Over All 8 Weeks of Treatment or Until Premature Discontinuation|Male participant needed to make a minimum of 4 attempts at SI and Baseline IELTs were assessed by stop watch measurements for each SI attempt. IELT was the elapsed time from vaginal penetration until ejaculation. On-treatment IELT for each participant was calculated by taking the median IELT from all valid on-treatment IELT attempts. Geometric mean IELT for each treatment was compared using analysis of covariance (ANCOVA). LS mean values and two-sided p-values are from the general linear model ln(median IELT)= ln(Baseline IELT) + treatment + cluster. A step-down procedure was used to determine if the efficacy of on-demand GSK557296 was superior to placebo. First, the average of the geometric mean IELTs of the pooled 150mg and 50mg doses of GSK557296 was tested against placebo, and if significance was achieved with this global plateau trend test (p < 0.05), then the simultaneous pair wise comparisons of the 150mg and 50mg doses to placebo would occur (each at an alpha level of 0.05).|Up to Week 8|Intent to Treat (ITT) Population consisted of all participants randomized to study treatment. Only those participants with data available at the indicated time points were analyzed.||minutes||Standard Error|Geometric Mean
808272|NCT01021618|Secondary|Myocardial Perfusion Image Quality|Single photon emission computed tomography myocardial perfusion acquisition and image processing was performed in accordance with American Society of Nuclear Cardiology guidelines. All images were interpreted by consensus read of three investigators blinded to stress test protocol and results. Overall perfusion and gated image quality were described as excellent (no artifacts interfering with myocardial perfusion interpretation), good, fair, or poor (artifact requiring reprocessing or repeat imaging of the patient to allow for diagnostic interpretation).|0 hours|Note that images were unavailable in one vasodilator-exercise patient because of urgent catheterization after stress test without imaging and one exercise-vasodilator patient for technical reasons.||participants|||Number
808273|NCT01021618|Primary|"Number of Participants With Major Adverse Events or Side Effects Graded Severe on Symptom Questionnaire"|"Number of participants with any side effect (flushing, shortness of breath, headache, chest discomfort, dizziness, nausea, or abdominal pain) requiring specific treatment or graded as severe by the patient; or any death, myocardial infarction, or unplanned hospitalization. Note that 2 patients allocated to exercise-vasodilator stress did not complete symptom questionnaires and are therefore excluded from analysis."|24 hours|Note that 2 patients allocated to exercise-vasodilator stress did not complete symptom questionnaires and are therefore excluded from analysis.||participants|||Number
822022|NCT01152385|Secondary|Number of Responders in Terms of HbA1C ≤ 7%||at 4th month|The analysis population was prior to rescue treatment (FAS)||Participants|||Number
808275|NCT01021683|Secondary|Percentage of Participants With Baseline Fungal Infection|Blood cultures (a laboratory test on a sample of blood) were assessed to identify fungus. Percentage of participants with presence or absence of fungus before starting the study drug were calculated.|Baseline (Day 0)|The ITT population included the participants who satisfied the eligibility criteria, received the study drug at least once, and in whom the primary efficacy endpoint was measured at least once.||Percentage of Participants|||Number
808276|NCT01021683|Secondary|Plasma Concentration of Itraconazole by Overall Success Rate (OSR) in Participants Who Received the Study Treatment|Plasma level of itraconazole was defined as the sum of IC and HIC. The OSR was defined based on satisfaction of the following criteria: (1) participants if treated for baseline fungal infection, there was either eradication (removal of fungus in culture), or presumed eradication; no evidence in culture but appeared to be treated clinically, (2) absence of breakthrough fungal infection during the treatment and for 7 days after completing the treatment, (3) survival for 7 days after completing the treatment, (4) absence of early withdrawal due to adverse events or lack of efficacy, and (5) defervescence. The presence and absence of OS was reported.|Day 5|The ITT population included the participants who satisfied the eligibility criteria, received the study drug at least once, and in whom the primary efficacy endpoint was measured at least once. Here, 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for given category.||ng/mL||Standard Deviation|Mean
808277|NCT01021683|Secondary|Percentage of Participants With Defervescence by Plasma Level of Itraconazole|Defervescence was defined as fall of the body temperature below 38.0 degree C at least once after starting to receive the study treatment. Plasma level of itraconazole was defined as the sum of IC and HIC.|Day 5|The ITT population included the participants who satisfied the eligibility criteria, received the study drug at least once, and in whom the primary efficacy endpoint was measured at least once. Here, 'n' signifies participants who were evaluable for this measure at given time points.||Percentage of Participants|||Number
808278|NCT01021683|Secondary|Absolute Neutrophil Count (ANC)|The mean values for ANC based on blood tests performed on Day 0 (before starting the study treatment) constitute a Baseline measure for ANC.|Baseline (Day 0)|The ITT population included the participants who satisfied the eligibility criteria, received the study drug at least once, and in whom the primary efficacy endpoint was measured at least once. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.||Cells/mm^3||Standard Deviation|Mean
808279|NCT01021683|Secondary|Duration of Neutropenia|The duration of neutropenia was reported. Neutropenia was defined as neutrophil count less than or equal to (<=) 500 cells per cubic millimeter (cells/mm^3), or neutrophil count <=1000 cells/mm^3 and anticipated to decrease to <=500 cells/mm^3 within several days.|Day 0 up to Day 14|The ITT population included the participants who satisfied the eligibility criteria, received the study drug at least once, and in whom the primary efficacy endpoint was measured at least once.||Days||Standard Deviation|Mean
808280|NCT01021683|Secondary|Mean Time to Defervescence in Participants Who Received the Study Treatment|The mean time to defervescence was reported in participants who received the study treatment. Defervescence was defined as fall of the body temperature below 38.0 degree C at least once after starting to receive the study treatment.|Day 0 up to Day 14|The ITT population included the participants who satisfied the eligibility criteria, received the study drug at least once, and in whom the primary efficacy endpoint was measured at least once. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.||Days||Standard Deviation|Mean
808281|NCT01021683|Secondary|Percentage of Participants With Deferevescence After Administration of Study Treatment|Defervescence was defined as fall of the body temperature below 38.0 degree Celsius (C) at least once after starting to receive the study treatment.|Day 0 up to Day 14|The ITT population included the participants who satisfied the eligibility criteria, received the study drug at least once, and in whom the primary efficacy endpoint was measured at least once.||Percentage of Participants|||Number
808282|NCT01021683|Primary|Percentage of Participants Achieving Plasma Level of Itraconazole at 1000 Nanogram Per Milliliter (ng/mL) or Higher After Administration of Study Treatment|Percentage of participants who achieved more than or equal to 1000 ng/ml level after administration of study treatment were reported. Plasma level of itraconazole was defined as the sum of itraconazole concentration (IC) and hydroxyitraconazole concentration (HIC).|Day 5|The intent-to-treat (ITT) population included the participants who satisfied the eligibility criteria, received the study drug at least once, and in whom the primary efficacy endpoint was measured at least once.||Percentage of Participants||95% Confidence Interval|Number
808283|NCT01021761|Primary|Aqueous PGE2 Inhibition|A spectroscopic quantification of PGE2 was performed on the aqueous humor samples collected with the results measured in pg/ml. PGE2 levels below 50 pg/ml were considered below the level of detection.|Day 4 of treatment|Protocol specified 126 subjects to be enrolled and analysis was performed per protocol.||pg/ml||Standard Deviation|Mean
808284|NCT01021813|Other Pre-specified|Number of Participants Who Reported Suicidal Ideation and/or Behavior On Study Based on Responses to the Columbia Suicide Severity Rating Scale (C-SSRS)|"Suicidal ideation and/or behavior that occurred on study was also assessed using the C-SSRS, a rater-administered questionnaire used to prospectively assess suicidal ideation and suicidal behavior. C-SSRS assessment was based upon a clinician's interpretation of the participant's responses to the C-SSRS questions, not by a numbered scale.
Suicidal ideation and/or behaviors identified on the C-SSRS may not have been considered an adverse event, based on the investigator's judgment."|From the first day of study treatment through study follow-up (up to 14 months)|All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment.||participants|||Number
808291|NCT01021813|Primary|Percentage of Participants Who Experienced Hypnagogic/Hypnopompic Hallucinations AEs During the DB Treatment Phase|Perceptual distortions associated with transitions between wakefulness and sleep were termed as hypnagogic (occurring during the onset of sleep) or hypnopompic (occurring during onset of wakefulness) hallucinations.|From the first day of study treatment up to 12 months|All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment.||percentage of participants|||Number
808480|NCT01033942|Primary|Perceived Risk of Becoming HIV Positive at Week 4|"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: Because I am in this PrEP study, I am less concerned about becoming HIV positive."|Week 4|Not all participants answered every question||percentage of participants|||Number
808285|NCT01021813|Secondary|Least Squares (LS) Mean Change From Baseline in Mean Subjective Time To Sleep Onset (sTSOm) During First Month of Treatment Phase|The sTSOm was defined as the average over time of daily e-diary values for a participant's report of the time he or she required to fall asleep (measured in minutes). Weekly sTSOm values (Week 1, Week 2, etc.) were the average of the daily e-diary values for the week. A summary value of this measure for Month 1 was obtained by taking the average of weekly sTSTm values for Weeks 1 through 4; (Week 1 + Week 2 + Week 3 + Week 4) ÷ 4. LS Mean Change from Baseline in sTSOm was then calculated at Week 1, Week 2, Week 3, Week 4, and Month 1.|Baseline, Week 1, Week 2, Week 3, and Week 4|Full Analysis Set (FAS)-Efficacy; all randomized participants who had ≥1 post-randomization observation for the analysis endpoint subsequent to ≥1 dose of study treatment, and baseline data for those analyses that required baseline data. The number included in the FAS may vary across endpoints due to the degree of missing data for each endpoint.||minutes||95% Confidence Interval|Least Squares Mean
808286|NCT01021813|Secondary|Least Squares (LS) Mean Change From Baseline in Mean Subjective Total Sleep Time (sTSTm) During First Month of Treatment Phase|The sTSTm was defined as the average over time of daily e-diary values for a participant's report of the total amount of time spent asleep before waking for the day (measured in minutes). Weekly sTSTm values (Week 1, Week 2, etc.) were the average of the daily e-diary values for the week. A summary value of this measure for Month 1 was obtained by taking the average of weekly sTSTm values for Weeks 1 through 4; (Week 1 + Week 2 + Week 3 + Week 4) ÷ 4. LS Mean Change from Baseline in sTSTm was then calculated at Week 1, Week 2, Week 3, Week 4, and Month 1.|Baseline, Week 1, Week 2, Week 3, and Week 4|Full Analysis Set (FAS)-Efficacy; all randomized participants who had ≥1 post-randomization observation for the analysis endpoint subsequent to ≥1 dose of study treatment, and baseline data for those analyses that required baseline data. The number included in the FAS may vary across endpoints due to the degree of missing data for each endpoint.||minutes||95% Confidence Interval|Least Squares Mean
808287|NCT01021813|Secondary|Percentage of Participants With Rebound As Defined By Increased Subjective Time to Sleep Onset (sTSO) During the DB Run-Out Phase|Rebound insomnia was defined as insomnia that occurred following discontinuation of a sedative substance taken to relieve primary insomnia, and was assessed based on subjective time to sleep onset (sTSO) as recorded in the participant’s morning e-diary. A strict categorical analysis method (Yes/No) was used in which a participant was considered to have potentially experienced rebound (Yes) if the Morning Diary participant-reported sTSO value (in minutes) on any of the first 3 nights of the Run-out Phase occurring after one year of treatment (Month 13) was greater than the last value at baseline one year earlier (Month 1).|Baseline (Month 1) and first 3 days of Randomized Discontinuation Phase (otherwise known as the Run-out, Month 13)|Participants in the APaT population who completed the entire DB Treatment Phase, had a baseline measurement, had taken at least one dose of DB Run-out study medication, and had a measurement on at least one of the nights of the DB Run-out Phase.||percentage of participants|||Number
808288|NCT01021813|Secondary|Percentage of Participants With Rebound As Defined By Decreased Subjective Total Sleep Time (sTST) During the DB Run-Out Phase|Rebound insomnia was defined as insomnia that occurred following discontinuation of a sedative substance taken to relieve primary insomnia, and was assessed based on subjective total sleep time (sTST) as recorded in the participant’s morning e-diary. A strict categorical analysis method (Yes/No) was used in which a participant was considered to have potentially experienced rebound (Yes) if the Morning Diary participant-reported sTST value (in minutes) on any of the 3 nights of the Run-out Phase (first 3 nights of the Discontinuation Phase) occurring after one year of treatment (Month 13) was less than the last value at baseline one year earlier (Month 1).|Baseline (Month 1) and first 3 days of Randomized Discontinuation Phase (otherwise known as the Run-out, Month 13)|Participants in the APaT population who completed the entire DB Treatment Phase, had a baseline measurement, had taken at least one dose of DB Run-out study medication, and had a measurement on at least one of the nights of the DB Run-out Phase.||percentage of participants|||Number
808289|NCT01021813|Secondary|Percentage of Participants With Withdrawal Symptoms During the DB Run-Out Phase: Tyrer Withdrawal Symptom Questionnaire (WSQ)|"Withdrawal effects assessed using Tyrer WSQ, which evaluated the presence/absence and severity of withdrawal symptoms with 20 items (i.e. sensitivity to noise, light, smell, touch, feeling unreal, etc). The Tyrer WSQ was completed as part of the evening e-diary prior to dosing on the Month 12 visit and on the 3 consecutive evenings of the DB Run-out Phase (first 3 nights of DB Discontinuation Phase). Responses rated 0 (No), 1 (Yes-moderate), or 2 (Yes-severe); range from 0 (no withdrawal) to 40 (severe withdrawal).
A participant was defined to have a withdrawal symptom if an item during any of the 3 DB Run-out days had emerged for the first time, or had worsened compared to the measurement obtained at the end of the Treatment phase (Month 12). For single night analysis, a patient was defined to have withdrawal effects if the number of withdrawal symptoms (emergent or worsening) was ≥3. For across night analysis, withdrawal was defined as a total of ≥3 symptoms across the 3 nights."|Evening of Month 12 visit and next 3 consecutive days (Night 1, 2, and 3 of Discontinuation Phase [otherwise known as the Run-out])|Participants in the APaT population who completed the entire DB Treatment Phase, had at least one measurement at the end of the DB Treatment Phase (Month 12), had taken at least one dose of Run-out study medication, and had a measurement on at least one of the nights of the DB Run-out Phase.||percentage of participants|||Number
808290|NCT01021813|Primary|Percentage of Participants Who Experienced Selected AEs Associated With Potential for Abuse During the DB Treatment Phase|The pre-specified terms which were suggestive of abuse potential on this study included depersonalization (feeling of watching oneself act, while having no control over a situation), derealization (alteration in the perception or experience of the external world so that it seems unreal), dissociation (includes a wide array of experiences from mild detachment from immediate surroundings to more severe detachment from physical and emotional experience), euphoric mood (exaggerated feeling of physical and emotional well-being and optimism not consonant with apparent stimuli or events), mania (state of abnormally elevated or irritable mood, arousal, and/or energy levels), hallucination (perception in the absence of a stimulus which has qualities of real perception), and potential study medication misuse.|From the first day of study treatment up to 12 months|All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment.||percentage of participants|||Number
808316|NCT01022307|Primary|Performance on Trail-making Test, Part B|z-score based on response time, regressed for age and computer use|Single session generally several years after TBI depending on time of recruitment of subjects.|z-score||z-score||Standard Deviation|Mean
808292|NCT01021813|Primary|Percentage of Participants Who Experienced Suicidal Ideation and/or Behavior AEs During the DB Treatment Phase|Suicidal ideation included suicidal plans, suicidal tendency, death wishes, life weariness, and suicidal intention. Suicidal behaviors included suicide attempts, suicide gesture, and self-injurious behaviour. Suicidal ideation and/or behavior was reported as an AE and considered an ECI.|From the first day of study treatment up to 12 months|All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment.||percentage of participants|||Number
808293|NCT01021813|Primary|Percentage of Participants Who Experienced Falls AEs During the DB Treatment Phase|Falls were adjudicated (to establish whether a fall event was due to cataplexy).|From the first day of study treatment up to 12 months|All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment.||percentage of participants|||Number
808294|NCT01021813|Primary|Percentage of Participants Who Experienced Complex Sleep-related Behaviors AEs During the DB Treatment Phase|Complex sleep-related behaviors were reported as ECIs and were characterized by patients engaging in specific activities while asleep (e.g., eating, drinking, preparing meals, making phone calls, having sex, driving, and sleep walking).|From the first day of study treatment up to 12 months|All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment.||percentage of participants|||Number
808295|NCT01021813|Primary|Percentage of Participants Who Experienced Sleep Paralysis AEs During the DB Treatment Phase|Sleep paralysis was defined as the inability to perform voluntary muscle movements during sleep. Sleep paralysis adverse events included sleep-onset paralysis (paralysis as one is falling asleep).|From the first day of study treatment up to 12 months|All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment||percentage of participants|||Number
808296|NCT01021813|Primary|Percentage of Participants Who Experienced Cataplexy Adverse Events (AEs) During the Double-Blind (DB) Treatment Phase|Cataplexy is defined as a sudden loss of muscle tone while awake which prevents voluntary movement.|From the first day of study treatment up to 12 months|All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment.||percentage of participants|||Number
808297|NCT01021852|Primary|Percentage of Participants That Discontinued Study Medication Due to an AE During Treatment Periods 1 and 2|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR’s product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR’s product, was also an AE. The percentage of participants that discontinued study medication due to AEs are presented for the first day of randomized treatment dosing (Day 1) through the last day of randomized treatment dosing (Day 29) in Treatment Periods 1 and 2.|Day 1 through Day 29 in Treatment Periods 1 and 2 (58 days total)|APaT population; all randomized participants who received at least one dose of study treatment. Participants were included corresponding to the study treatment they actually received for a given period.||percentage of participants|||Number
808298|NCT01021852|Primary|Percentage of Participants With at Least One Adverse Event (AE) During Treatment Periods 1 and 2|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR’s product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR’s product, was also an AE. The percentage of participants with AEs are presented for the first day of randomized treatment dosing (Day 1) through the last day of randomized treatment dosing (Day 29) in Treatment Periods 1 and 2.|Day 1 through Day 29 in Treatment Periods 1 and 2 (58 days total)|All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment. Participants were included corresponding to the study treatment they actually received for a given period.||percentage of participants|||Number
808299|NCT01021852|Secondary|Latency to the Onset of Persistent Sleep (LPS) on Night 1 and After 4 Weeks of Treatment|LPS was measured using a PSG, which consisted of an EEG for registration of brain activity during sleep, an EOG for registration of the eye movements during sleep, and an EMG for recording chin muscle activity during sleep. Sleep stage scoring was performed visually in 30-second epochs according to R&K criteria and PSG data were read by a Central Reader. LPS was defined as the duration of time measured in minutes from lights off to persistent sleep onset. An epoch of non-wake was defined as a 30-second interval classified as either Stage 1, 2, 3, 4 or REM according to conventional R&K scoring. LS mean LPS was reported for each treatment arm.|Night 1 and end of Week 4|FAS population; subset of all randomized participants who received at least one dose of study medication and had any post-randomization LPS efficacy assessment data. The FAS population may have varied across endpoints due to the degree of missing data for each endpoint.||minutes||Standard Error|Least Squares Mean
808300|NCT01021852|Secondary|Wake After Persistent Sleep Onset (WASO) on Night 1 and After 4 Weeks of Treatment|WASO was measured using a PSG, which consisted of an EEG for registration of brain activity during sleep, an EOG for registration of the eye movements during sleep, and an EMG for recording chin muscle activity during sleep. Sleep stage scoring was performed visually in 30-second epochs according to R&K criteria and PSG data were read by a Central Reader. WASO was defined as the duration of wakefulness measured in minutes (any epoch of Stage 0) from persistent sleep onset (first epoch of the first twenty consecutive epochs of non-wake) to lights on. LS mean WASO was reported for each treatment arm.|Night 1 and end of Week 4|FAS population; subset of all randomized participants who received at least one dose of study medication and had any post-randomization WASO efficacy assessment data. The FAS population may have varied across endpoints due to the degree of missing data for each endpoint.||minutes||Standard Error|Least Squares Mean
808317|NCT01022398|Primary|Determine if the Replacement of Vitamin D 10,000 IU Weekly Will Decrease the Discontinuation Rate of Statin Therapy and Decrease the Incidence of Statin-related Myalgia in Patients Requiring Statin Therapy||6 months||||||
808318|NCT01022502|Secondary|Patients Preferred Ointment Type.|At the end of the trial, the patients were asked which ointment they preferred.|Week 8|Total number of participants completing the 8 week period with study intervention.||participants|||Number
822023|NCT01152385|Secondary|Change in Fasting Plasma Glucose (FPG)||from baseline to 4 months|The analysis population was prior to rescue treatment (FAS)||mg/dL||Standard Deviation|Mean
808301|NCT01021852|Primary|Sleep Efficiency (SE) on Night 1 and After 4 Weeks of Treatment|SE was measured using a polysomnogram (PSG), which consisted of an electroencephalogram (EEG) for registration of brain activity during sleep, an electro-oculogram (EOG) for registration of the eye movements during sleep, and an electromyogram (EMG) for recording chin muscle activity during sleep. Sleep stage scoring was performed visually in 30-second epochs according to Rechtschaffen and Kales (R&K) criteria and PSG data were read by a Central Reader. SE was defined as total sleep time (TST) in minutes divided by time in bed (measured from lights off to lights on; fixed at 8 hours on each PSG night) in minutes, multiplied by 100, where TST is defined as the total time (minutes) in Stages 1, 2, 3, 4 and Rapid Eye Movement (REM). SE= (total sleep time/time in bed) x 100. Least squares (LS) mean SE was reported for each treatment arm.|Night 1 and end of Week 4|Full Analysis Set (FAS) population; subset of all randomized participants who received at least one dose of study medication and had any post-randomization SE efficacy assessment data. The FAS population may have varied across endpoints due to the degree of missing data for each endpoint.||percentage of time in bed spent sleeping||Standard Error|Least Squares Mean
808302|NCT01021878|Secondary|Total Ultrafiltration|Total ultrafiltration obtained in 24 hours was obtained and compared between groups using analysis of covariance (ANCOVA). The baseline values of total ultrafiltration was used as covariate, the groups as the fixed factor and the value obtained at 90 days as the dependent variable.|3 months|||millilitre||95% Confidence Interval|Mean
808303|NCT01021878|Secondary|Glycated Hemoglobin|"Adjusted glycated hemoglobin was obtained and compared between groups using analysis of covariance (ANCOVA). The baseline values of HbA1c was used as covariate, the groups as the fixed factor and the value obtained at 90 days as the dependent variable.
Glycated hemoglobin was measured by high-performance liquid chromatography."|3 months|||percentage of haemoglobin||95% Confidence Interval|Mean
808304|NCT01021878|Secondary|Serum Insulin|Serum insulin was log-transformed to meet all criteria for ANCOVA. The baseline value was treated as covariate, groups as the fixed factor and the serum insulin at 3 months as the dependent variable. Serum insulin was measured in oral fasting by chemioluminescense.|3 months|||log(mmol/L)||95% Confidence Interval|Mean
808305|NCT01021878|Secondary|Oral Fasting Serum Glucose|"Serum glucose measured in oral fasting but not peritoneal fasting.
For this outcome we compared groups using analysis of covariance (ANCOVA) using the baseline values as covariate, groups as the fixed factor and the value obtained at 90 days as the dependent variable. Significance level for alpha was setting at < 0.05."|3 months|||mg/dl||95% Confidence Interval|Mean
808306|NCT01021878|Primary|Adjusted HOMA Index Score at 3 Months Using Baseline Values as a Covariate and Groups as the Fixed Factor|"Adjusted HOMA index score at 3 months using baseline values as a covariate and groups as the fixed factor. HOMA index was calculated as follows:
(fasting glucose(mg/dl) x fasting serum insulin (μU/mL))/405"|3 months|||IR score||95% Confidence Interval|Mean
808307|NCT01022073|Primary|Off-medication/On-stimulation Motor Function Score of the Unified Parkinson's Disease Rating Scale (UPDRS Part III)|The primary outcome measure for the comparison of GPi deep brain stimulation (DBS) to STN DBS is the motor function score of the Unified Parkinson's Disease Rating Scale (UPDRS Part III) measured while the patient is off medications and on stimulation at follow-up visits post surgery. UPDRS Part III has 14 items assessing motor skills including facial expression and speech, tremors, rigidity, posture, gait, and bradykinesia. Left and right sides (arms, legs, and hands) are assessed separately for seven of the functions. A summary score ranging from 0 to 108 is generated by adding the 14 specific motor function responses. The motor function (UPDRS part III) assessments are done by turning on the stimulation with and without taking PD medications (on/off) at each in-person visit. The higher the value, the worse the outcome.|The change score of UPDRS Part III from baseline to 9 years post surgery|Patients had completed the 9 year follow-up post surgery||units on a scale||Standard Deviation|Mean
808308|NCT01022112|Secondary|Safety and Tolerability||14 weeks||||||
808309|NCT01022112|Secondary|Fasting Blood Glucose, Body Weight||12 weeks||||||
808310|NCT01022112|Primary|Change in Hemoglobin A1c (A1C) From Baseline (NGSP Value)||12 weeks|Full analysis set, last observation carried forward||percent HbA1C||Standard Error|Least Squares Mean
808311|NCT01022190|Primary|Percentage of Participants With Heterotopic Ossification (HO) at 6 Months Postoperatively.|"Percentage of participants in which Heterotopic Ossification of the hip was assessed, according to the Brooker grade.
Brooker-0): No ossification. Brooker-1): Isolated bone islands, Brooker-2): Bone spurs from the pelvis or proximal femur;space between opposing surface ≥ 1 cm, Brooker-3): Bone spurs from the pelvis or proximal femur;space between opposing surface < 1 cm, Brooker-4): Apparent bony ankylosis. Brooker score 1 to 4 are considered 'heterotopic ossification'."|6 months postoperatively|Patients who underwent total hip arthroplasty and received afterwards Etoricoxib medication.||percentage of participants|||Number
808312|NCT01022203|Secondary|Emotion Regulation|Measured with the Difficulties in Emotion Regulation Scale which measures severity of emotion regulation problems (Scores range from 36-125 with higher scores indicating higher levels of emotion regulation problems).|Pre-Treatment, Post-treatment (12 weeks), Follow-up (12 weeks after post-treatment).|Data collected from 44 veterans participating in Structured Approach Therapy and 42 veterans participating in PTSD Family Education.||units on a scale||Standard Deviation|Mean
808313|NCT01022203|Secondary|Relationship Functioning|Relationship functioning is defined as relationship adjustment; measured with the Dyadic Adjustment Scale. The Dyadic Adjustment Scale scores range from 0-151 with high scores indicating high levels of relationship adjustment.|Pre-Treatment, Post-treatment (12 weeks), Follow-up (12 weeks after post-treatment).|Data collected from 44 veterans participating in Structured Approach Therapy and 42 veterans participating in PTSD Family Education.||units on a scale||Standard Deviation|Mean
808314|NCT01022203|Primary|Psychological Functioning|Clinician-Rated PTSD measured with the Clinician Administered PTSD Scale (Score range 0-133 with high scores indicating more severe PTSD); Self-Rated PTSD measured with the PTSD Checklist (Score range 17-85 with high scores indicating more severe PTSD).|Pre-Treatment, Post-treatment (12 weeks), Follow-up (12 weeks after post-treatment).|Outcome data collected from 44 veterans who participated in Structured Approach Therapy and 42 Veterans who participated in PTSD Family Education.||units on a scale||Standard Deviation|Mean
808315|NCT01022242|Primary|TAM2|The primary variable is TAM2: The sum of Total Active Motion at the proximal interphalangeal (PIP) and distal interphalangeal (DIP) joints of the affected digit at actively made fist minus the extensor lag at these joints.|At 12 weeks after surgery|FAS population||Degrees||Full Range|Median
808319|NCT01022502|Secondary|Patients' Rating of the Overall Improvement at Week 8|At week 8, patients rated an overall response to treatment (separately for each side of the body), taking into account both the extent and the degree of the disease, compared with the pretreatment condition, on a 6-point scale (0=worse,1=poor, 2=fair, 3=good, 4=excellent, 5=cleared). A score of 4 or higher represents a better outcome.|Baseline and Week 8|Total number of participants completing the 8 week period with study intervention and who reported excellent or cleared at week 8 were used for analysis.||participants|||Number
808320|NCT01022502|Primary|Percentage Improvement Compared to Baseline in the Target Plaque.|The improvement percentage of the target plaque at the follow-up visit was calculated as: [(Area of baseline plaque*PSI of baseline plaque - Area of plaque week 8*PSI of plaque week 8)/(Area of baseline plaque*PSI of baseline plaque)]*100%. Higher values represent a better outcome. For expample, a higher percent represents an improvement.|Baseline and Week 8|Total number of participants completing the 8 week period with study intervention. The paired t-test was used to compared percent of improvement related to baseline between the two lesions and before treatment with those after treatment.||percent change of target plaque||95% Confidence Interval|Mean
808321|NCT01022502|Primary|Clearing Percentage of Target Plaque Area|The target plaque area was rated from 0% to 100% (0%=clearance after treatment and 100%=baseline before treatment). Higher values represent a worse outcome. For expample, a lower percentage after treatment represent an improvement.|Baseline and Week 8|Total number of participants completing the 8 week period with study intervention. The paired t-test was used to compared clearing percent of target plaque between the two lesions and before treatment with those after treatment.||percentage of the target area||95% Confidence Interval|Mean
808322|NCT01022502|Primary|Change From Baseline in Psoriasis Severity Idex(PSI) at Week 8.|The PSI score is comprised of the grading for scaling, erythema, and induration on a 5-point scale (where 0=absent, 1=mild, 2=moderate, 3=severe and 4=very severe) and the sum of these three items with a minimal score of 0 and a maximum of score of 12. Higher values represent a worse outcome. For expample, a highter PSI score at baseline and lower PSI score after treatment represent an improvement.|Baseline and Week 8|Total number of participants completing the 8 week period with study intervention. The paired t-test was used to compared PSI scores between the two lesions and before treatment with those after treatment.||units on a scale||95% Confidence Interval|Mean
808323|NCT01028651|Secondary|Change in Plasma Brain N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) From Baseline to Weeks 12 and 24|NT-proBNP was assessed at Baseline, Weeks 12 and 24.|Baseline to Weeks 12 and 24|All subjects with data available at Baseline and Weeks 12 and 24.||pg/mL||Full Range|Median
808324|NCT01028651|Secondary|Change in Quality of Life From Baseline to Weeks 12 and 24|The 36-item Short Form Survey (SF-36) is a health related quality of life instrument, which measures dimensions of physical and social roles and functioning, mental health, vitality, and pain. Items are scored on a 0 to 100 range so that the lowest scores represent the highest disability. The quality of life assessment was conducted at Baseline and Weeks 12 and 24 and the change from Baseline to Weeks 12 and 24 is presented.|Baseline and Weeks 12 and 24|All subjects with data available at Baseline and Weeks 12 and 24.||units on a scale||Full Range|Median
808325|NCT01028651|Secondary|Change in Echocardiogram Parameters (Tricuspid Annular Plane Systolic Excursion) From Baseline to Weeks 12 and 24|Standard transthoracic echocardiogram with continuous wave Doppler and color flow imaging was completed at Screening. All patients who were enrolled in this study underwent an echocardiogram within 30 days of enrollment as well as repeat echocardiograms on Weeks 12 and 24.|Baseline and Weeks 12 and 24|All subjects with data available at Baseline and Weeks 12 and 24.||cm||Full Range|Median
808326|NCT01028651|Secondary|Change in Echocardiogram Parameters (Right Ventricular Systolic Pressure) From Baseline to Weeks 12 and 24|Standard transthoracic echocardiogram with continuous wave Doppler and color flow imaging was completed at Screening. All patients who were enrolled in this study underwent an echocardiogram within 30 days of enrollment as well as repeat echocardiograms on Weeks 12 and 24.|Baseline and Weeks 12 and 24|All subjects with data available at Baseline and Weeks 12 and 24.||mmHg||Full Range|Median
808327|NCT01028651|Secondary|Change in Echocardiogram Parameters (Right Ventricle Diameter) From Baseline to Weeks 12 and 24|Standard transthoracic echocardiogram with continuous wave Doppler and color flow imaging was completed at Screening. All patients who were enrolled in this study underwent an echocardiogram within 30 days of enrollment as well as repeat echocardiograms on Weeks 12 and 24.|Baseline and Weeks 12 and 24|All subjects with data available at Baseline and Weeks 12 and 24.||mm||Full Range|Median
808328|NCT01028651|Secondary|Change in Echocardiogram Parameters (Right Atrium and Right Ventricle Area) From Baseline to Weeks 12 and 24|Standard transthoracic echocardiogram with continuous wave Doppler and color flow imaging was completed at Screening. All patients who were enrolled in this study underwent an echocardiogram within 30 days of enrollment as well as repeat echocardiograms on Weeks 12 and 24.|Baseline and Weeks 12 and 24|All subjects with data available at Baseline and Weeks 12 and 24.||cm2||Full Range|Median
808329|NCT01028651|Secondary|Change in 6-minute Walk Distance (6MWD) From Baseline to Weeks 12 and 24.|The 6-Minute Walk Test was conducted at Screening, Baseline prior to starting study drug and at least 24 hours after the Screening test, and during the Treatment Phase at Weeks 12 and 24.|Baseline and Weeks 12 and 24|All subjects with data available at Baseline and Weeks 12 and 24||Meters||Full Range|Median
808330|NCT01028651|Secondary|Change in Pulmonary Vascular Resistance (PVR) at Rest From Baseline to Week 24|The change in pulmonary vascular resistance (PVR) was evaluated at rest from Baseline to Week 24.|24 weeks|All subjects with data available at Baseline and Week 24||Wood Units||Full Range|Median
808331|NCT01028651|Secondary|Change in Arterial and Venous Oxygen Saturation at Rest From Baseline to Week 24|The change in arterial and venous oxygen saturation was evaluated at rest from Baseline to Week 24.|24 weeks|All subjects with data available at Baseline and Week 24||percentage bound to hemoglobin||Full Range|Median
808332|NCT01028651|Secondary|Change in Cardiac Output at Rest From Baseline to Week 24|The change in cardiac output was evaluated at rest from Baseline to Week 24. The median change in cardiac output from Baseline to Week 24 is presented.|24 weeks|All subjects with data available at Baseline and Week 24||L/min||Full Range|Median
808333|NCT01028651|Secondary|Change in Heart Rate at Rest From Baseline to Week 24|The change in heart rate was evaluated at rest from Baseline to Week 24.|24 weeks|All subjects with data available at Baseline and Week 24||beats/min||Full Range|Median
822024|NCT01152385|Primary|Change in Haemoglobin A1c (HbA1c)||from baseline to 4 months|The analysis population was prior to rescue treatment (FAS)||Percentage||Standard Deviation|Mean
808334|NCT01028651|Secondary|Change in Hemodynamic Parameters (Via Right Heart Catheterization [RHC]) at Rest From Baseline to Week 24|The change in hemodynamic parameters (including systolic pulmonary arterial pressure [PAPs], diastolic pulmonary arterial pressure [PAPd], mean pulmonary arterial pressure [mPAP], and transpulmonary gradient [TPG]) was evaluated at rest from Baseline to Week 24. The median change in hemodynamic parameters from Baseline to Week 24 via right-heart catheterization (RHC) is presented.|24 weeks|All subjects with data available at Baseline and Week 24||mmHg||Full Range|Median
808335|NCT01028651|Primary|Number of Subjects Who Achieved Hemodynamic Parameters Appropriate for Orthotopic Liver Transplantation Candidacy at Week 24.|The primary efficacy endpoint was the number of subjects who achieved a mean pulmonary arterial pressure (mPAP) less than 35 mmHg and a pulmonary vascular resistance (PVR) less than 3 Wood units (WU) at Week 24 in patients with severe portopulmonary hypertension (PoPH).|24 Weeks|The total number of subjects enrolled and analyzed.||participants|||Number
808336|NCT01028677|Primary|Empathy as Measured by the Interpersonal Reactivity Index (IRI) at 6 Weeks|"The Interpersonal Reactivity Index (IRI; Davis, 1983) is a self-report measure of cognitive and affective empathy. The IRI consists of 28 items where participants rate how well each item describes them using a five-point scale (1 to 5). The 28 items yield four subscales: perspective taking (PT), empathic concern (EC), fantasy (F), and personal distress (PD). Higher scores indicate a greater empathic response.
Score range for IRI: min, max Total: 28, 140 PT: 7, 35 EC: 7, 35 F: 7, 35 PD: 7, 35"|6 weeks|||rating on a scale||Standard Deviation|Mean
808337|NCT01028677|Primary|Social Perception as Measured by the Trustworthiness Task at 6 Weeks|The Trustworthiness Task (Adolphs, Tranel, & Damasio, 1998) is comprised of 42 black and white photographs of the faces of unfamiliar people. Participants are shown each picture individually (on a computer monitor) and asked to rate how much they would trust that person (e.g., with their money) on a seven-point scale, ranging from -3 (very untrustworthy) to +3 (very trustworthy). They are provided with a photograph of 0 or an average face (i.e., someone they would neither trust nor distrust) to refer to throughout the task (based on Adolphs et al.’s, 1998 norms). The total score is the sum of the trustworthiness ratings. Possible range is -126 to 126.|6 weeks|||rating on a scale||Standard Deviation|Mean
808338|NCT01028677|Primary|Theory of Mind as Measured by the Brune Test at 6 Weeks|In The Brune Test (Brune, 2003), participants are shown a series of six sets of four cartoon pictures that illustrate interactions between two or more individuals. The cartoon cards were displayed to the participant in a predetermined scrambled order. Participants are asked to rearrange the pictures in an order that conveys a logical story. After the participant arranges the cards, the examiner ensures they are in the correct sequence. If they are not in the correct order, the examiner silently arranges them so they are in the logical sequence.The participant’s interpretations of the characters’ beliefs are scored as correct or incorrect (zero or one), with higher scores indicating better Theory of Mind. The sum of correct answers is the outcome of interest. The participants can receive a maximum total of 23 points for the questions.|6 weeks|||correct responses||Standard Deviation|Mean
808339|NCT01028677|Primary|Theory of Mind as Measured by the Eyes Test at 6 Weeks|The Eyes Test (Baron-Cohen, Wheelwright, Hill, Raste, & Plumb, 2001) consists of 36 photographs where participants are asked to guess the mental state (i.e., what the person is thinking or feeling) from among four choice words. Participants are given a practice item to ensure that they understand the task. Each eye region is displayed on a computer screen with the four choice mental states shown in the four corners of the computer screen (one target word and three foil words). The score range is 0 (no correct responses) to 36 (all stimuli are correctly identified).|6 weeks|||correct responses||Standard Deviation|Mean
808340|NCT01028677|Secondary|Clinical Psychiatric Symptoms as Measured by Positive and Negative Syndrome Scale (PANSS) at 6 Weeks|"The PANSS consists of 30 items (7 positive psychotic symptoms, 7 negative psychotic symptoms, 16 general psychopathology symptoms) on which subjects are rated (1-7) based upon a semi-standardized interview. Higher scores indicate more/greater symptoms (i.e., greater symptoms of psychosis) and lower scores indicate fewer symptoms (better outcome).
Possible score range: min, max Total: 30,210 Positive symptoms:7, 49 Negative symptoms:7, 49 General symptoms: 16,112"|6 weeks|||rating on a scale||Standard Deviation|Mean
808341|NCT01028677|Primary|Emotion Recognition as Measured by the Emotion Recognition-40 at the 6 Week Time Point|"The Emotion Recognition-40 (ER-40; Kohler, Turner, Gur, & Gur, 2004) consists of a series of 40 faces, shown one at a time on a computer screen. Participants choose the correct emotions based on 5 answer choices: happy, sad, anger, fear and no emotion. Participants indicate the word that best describes the emotion each faces expresses. The stimuli are presented in a randomized order each time they are administered. A scoring program automatically records accuracy and median response time. Range for each emotion (score range) is 0 (no correct responses) to 8 (all faces on each emotion category are correctly identified).
The ER-40 faces were derived from the University of Pennsylvania Emotion Recognition Task, 96 faces version, and are balanced for equality and intensity of emotion, age, gender and ethnicity."|6 weeks|||number of correct responses||Standard Deviation|Mean
808342|NCT01033383|Secondary|Not Growth|The number of not growth, these include no growth, growth <100,000 CFU/ml, growth >100,000 CFU/ml but no WBCs, and mixed flora.|one month|The analysis population were those with completed labs data.||urine cultures and urinalyses|Participants||Number
808343|NCT01033383|Secondary|Other Bacteriuria Plus Pyuria|The number of urine cultures and urinalyses (obtained weekly) found with other bacteriuria plus any white blood cells (WBCs) >100,000 colony that include: Proteus, Klebsiella, Enterococcus, beta-hemolytic Streptococci, viridans Streptococci, and organella morganii, Citrobacter freundii, and coagulase-negative Staphylococcus.|one month|The analysis population were those with completed labs data.||urine cultures and urinalyses|Participants||Number
808344|NCT01033383|Primary|E.Coli Bacteriuria Plus Pyuria|The number of urine cultures and urinalyses (obtained weekly) found with >100,000 CFU/ml growth of E.coli and >10 WBC.|One month|The analysis population were those with completed labs data.||urine cultures and urinalyses|Participants||Number
808345|NCT01033448|Secondary|Percentage of Participants With Adverse Event (AE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Week 96|All enrolled participants were analyzed||Percentage of Participants|||Number
808346|NCT01033448|Primary|SVR Rates in Genotype 2 and 3.|Sustained Viral Response, undetectable HCV-RNA 24 weeks after the end of treatment for genotype 2 and 3.|Week 72|Participants with CHC Genotype 2 & 3 at week 72.||Percentage of participants||95% Confidence Interval|Number
808350|NCT01033487|Secondary|Change From Baseline in Inspiratory Capacity (IC)|IC was the maximum volume of air that can be inhaled in to the lungs after breathing out normally. Baseline IC value was calculated as average of two largest pre-dose readings on Day 1 for each period. Change from baseline in IC was the difference between IC and baseline IC.|Baseline, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 24.5, 36, 48 hrs pot-dose|FAS population included all randomized participants and who had received at least one dose of randomized treatment.||Liter||Standard Deviation|Mean
808351|NCT01033487|Secondary|Change From Baseline in Force Vital Capacity (FVC)|FVC was the maximum amount of air exhaled from the lungs after taking the deepest breath possible. Baseline FVC value was calculated as average of two largest pre-dose readings on Day 1 for each period. Change from baseline in FVC was the difference between FVC and baseline FVC.|Baseline, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 24.5, 36, 48 hrs post-dose|FAS population included all randomized participants and who had received at least one dose of randomized treatment.||Liter||Standard Deviation|Mean
808352|NCT01033487|Secondary|Weighted Average Forced Expiratory Volume in 1 Second (FEV1) Response|FEV1 was the mean volume of air that can be forced out in 1 second after taking a deep breath. Weighted average FEV1 was defined as the average area under the effect curve (AUEC) change from baseline FEV1 (the area under the FEV1 effect curve over 24.5 hrs post-dose for each study period corrected for the pre-dose baseline value) divided by 24.5. Baseline FEV1 value was calculated as the average of two largest pre-dose readings on Day 1 for each period.|Baseline up to 24.5 hrs post-dose|FAS population included all randomized participants and who had received at least one dose of randomized treatment.||Liter||Standard Deviation|Mean
808353|NCT01033487|Secondary|Peak Forced Expiratory Volume in 1 Second (FEV1)|FEV1 was the mean volume of air that can be forced out in 1 second after taking a deep breath. Peak FEV1 was defined as change from baseline in maximum FEV1. Maximum FEV1 = maximum forced expiratory volume in 1 second, recorded between 0.5 hrs to 48 hrs post-dose. Baseline FEV1 value was calculated as average of two largest pre-dose readings on Day 1 for each period.|Baseline up to 48 hrs post-dose|FAS population included all randomized participants and who had received at least one dose of randomized treatment.||Liter||Standard Deviation|Mean
808354|NCT01033487|Primary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose|Data was not analyzed because a well characterized terminal phase was not observed for the parameter.|||||
808355|NCT01033487|Primary|Dose Normalized Area Under the Curve From Time Zero Extrapolated to Infinite Time|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It was obtained from AUC (0 - t) plus AUC (t-∞). AUC (0-∞) was dose normalized to a 1 mcg fine particle dose (40, 128 and 320 mcg for the nominal doses of 180, 580 and 1450 mcg respectively).|1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose|Data was not analyzed because a well characterized terminal phase was not observed for the parameter.|||||
808356|NCT01033487|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC(0-∞)]|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It was obtained from AUC (0 - t) plus AUC (t-∞).|1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose|Data was not analyzed because a well characterized terminal phase was not observed for the parameter.|||||
808357|NCT01033487|Primary|Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). AUClast was normalized to a 1 mcg fine particle dose (40, 128 and 320 mcg for the nominal doses of 180, 580 and 1450 mcg respectively).|1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.||(pg*hr/mL)/mcg||Standard Deviation|Geometric Mean
808358|NCT01033487|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).|1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.||pg*hr/mL||Standard Deviation|Geometric Mean
808359|NCT01033487|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.||hr||Full Range|Median
808360|NCT01033487|Primary|Dose Normalized Maximum Observed Plasma Concentration|Cmax was normalized to a 1 mcg fine particle dose (40, 128 and 320 mcg for the nominal doses of 180, 580 and 1450 mcg respectively).|1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.||(pg/mL)/mcg||Standard Deviation|Geometric Mean
808361|NCT01033487|Primary|Maximum Observed Plasma Concentration (Cmax)||1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose|Pharmacokinetic (PK) parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.||Picogram/milliliter (pg/mL)||Standard Deviation|Geometric Mean
808362|NCT01033487|Primary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1)|FEV1 was the mean volume of air that can be forced out in 1 second after taking a deep breath. Trough FEV1 was calculated as the average of the largest FEV1 value from 3 readings recorded at 24 hours (hrs) and 24.5 hrs post-dose. Baseline FEV1 value was calculated as average of 2 largest pre-dose readings on Day 1 for each period. Change from baseline in trough FEV1 was the difference between trough FEV1 and baseline FEV1.|Baseline, 24, 24.5 hrs post-dose|Full Analysis Set (FAS) population included all randomized participants and who had received at least one dose of randomized treatment.||Liter||Standard Deviation|Mean
808363|NCT01033565|Primary|Clinical Global Impression-Improvement|Assigns numerical score indicating level of improvement compared to baseline. Scale is rated from 1-7: 1= very much improved; 2= much improved; 3= minimally improved; 4= no change; 5= minimally worse; 6= much worse; 7= very much worse.|2 weeks|||units on a scale|||Number
822943|NCT01165983|Secondary|Absolute Change in Biochemical Markers of Endothelial Function, t-PAI, pg/mL||12 Weeks post-randomization|||pg/mL||Inter-Quartile Range|Median
808364|NCT01033734|Secondary|Participants With Greater Than or Equal to (>=) 5−Fold Change in Neuraminidase Inhibition (NAI) Assay 50 Percent (%) Inhibitory Concentration (IC50) Values|IC50 was defined as the concentration that causes 50% inhibition of viral activity. IC50 values were calculated using NAI assay. The 5-fold change was calculated as either >=5 times change in the NAI IC50 visit value from the Reference value at a visit, >=5 times change in the NAI IC50 Visit value from the Baseline value.|Baseline, Day 1, 6 and 30|Safety population included all participants who received at least one dose of IV study medication and had a safety assessment performed after initiation of treatment. Here, number of participants analyzed = participants evaluable for this outcome measure, and n = participants evaluable for specified time-point, for each arm, respectively.||Participants|||Number
808365|NCT01033734|Secondary|Volume of Distribution (V) of Oseltamivir and Oseltamivir Carboxylate||Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion|Data not collected because of changes in planned analysis, due to early study termination.|||||
808366|NCT01033734|Secondary|Total Clearance of Drug (CL) of Oseltamivir and Oseltamivir Carboxylate||Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion|Data not available as no participant was evaluable for specified time-points.|||||
808367|NCT01033734|Secondary|Elimination Rate Constant (ke) of Oseltamivir and Oseltamivir Carboxylate||Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion|Data not available as no participant was evaluable for specified time-points.|||||
808368|NCT01033734|Secondary|Time of the Last Measurable Plasma Concentration (Tlast) of Oseltamivir and Oseltamivir Carboxylate||Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion|PK population. Number of participants analyzed = participants who were evaluable for this outcome, n = number of participants evaluable for specified categories.||hours||Geometric Coefficient of Variation|Geometric Mean
808369|NCT01033734|Secondary|Last Measurable Plasma Concentration (Clast) of Oseltamivir and Oseltamivir Carboxylate||Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion|PK population. Number of participants analyzed = participants who were evaluable for this outcome, n = number of participants evaluable for specified categories.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
808370|NCT01033734|Secondary|Time to the Maximum Observed Plasma Concentration (Tmax) of Oseltamivir and Oseltamivir Carboxylate||Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion|PK population. Number of participants analyzed = participants who were evaluable for this outcome, n = number of participants evaluable for specified categories.||hours||Geometric Coefficient of Variation|Geometric Mean
808371|NCT01033734|Primary|Cmax of Oseltamivir and Oseltamivir Carboxylate Day 5||Day 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion|PK population. Number of participants analyzed = participants who were evaluable for this outcome.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
808372|NCT01033734|Primary|Cmax of Oseltamivir and Oseltamivir Carboxylate Day 4||Day 4: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion|PK population. Number of participants analyzed = participants who were evaluable for this outcome.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
808373|NCT01033734|Primary|Cmax of Oseltamivir and Oseltamivir Carboxylate Day 3||Day 3 (with or after fifth dose): 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion|PK population. Number of participants analyzed = participants who were evaluable for this outcome.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
808374|NCT01033734|Primary|Cmax of Oseltamivir and Oseltamivir Carboxylate Day 2||Day 2: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion|PK population. Number of participants analyzed = participants who were evaluable for this outcome.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
808375|NCT01033734|Primary|Maximum Observed Plasma Concentration (Cmax) of Oseltamivir and Oseltamivir Carboxylate Day 1||Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion|PK population. Number of participants analyzed = participants who were evaluable for this outcome.||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
808376|NCT01033734|Primary|AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 5||Day 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion|PK population. Number of participants analyzed = participants who were evaluable for this outcome.||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
808377|NCT01033734|Primary|AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 4||Day 4: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion|PK population. Number of participants analyzed = participants who were evaluable for this outcome.||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
808378|NCT01033734|Primary|AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 3||Day 3 (with or after fifth dose): 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion|PK population. Number of participants analyzed = participants who were evaluable for this outcome.||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
808379|NCT01033734|Primary|AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 2||Day 2: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion|PK population. Number of participants analyzed = participants who were evaluable for this outcome.||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
808380|NCT01033734|Primary|Area Under the Concentration Versus Time Curve From Time Zero to Last Measurable Plasma Concentration (AUClast) of Oseltamivir and Oseltamivir Carboxylate on Day 1||Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion.|Pharmacokinetic (PK) population included all treated participants who had at least one blood sample evaluable for drug concentration level. Number of participants analyzed = participants who were evaluable for this outcome.||hour*nanogram/milliliter (h*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
808481|NCT01033942|Primary|Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 24||Week 24|Not all participants answered every question||participants|||Number
808381|NCT01033747|Secondary|Relative Change in Serum Ferritin From Baseline to 3.5 Years|The mean percentage change in serum ferritin was evaluated by comparing the serum ferritin level at the start of Deferasirox treatment to the serum ferritin level collected 18 months following the start of the extension study. Serum ferritin is measured in micrograms per Liter. Relative Change = 1- (Change in ferritin level from Baseline/Baseline level) x 100.|Baseline to 3.5 years|All participants comprised of the full analysis set were evaluated for the change in serum ferritin.||Percent change||Full Range|Mean
808382|NCT01033747|Primary|The Relative Change From Baseline in Liver Iron Content (LIC) After Prolonged Use of Deferasirox|The mean percentage change in liver iron content (LIC) as assessed by superconducting quantum interference device (SQUID) was evaluated by comparing the LIC at the start of Deferasirox treatment to the LIC at the end of the 5 year extension study for participants who were treated with Deferasirox for more than 3.5 years. LIC is expressed in milligrams of iron per gram of liver dry weight (mgFe/g dw). Relative change = 1- (Change in LIC from Baseline/Baseline level) x 100.|Baseline to 7 Years|All participants in the full analysis set treated with deferasirox for more than 3.5 years.||Percent change||Full Range|Mean
808383|NCT01033825|Secondary|Percentage of Devices With Major Discrepancies|A major discrepancy is defined as a discrepancy of >20 actuations between the dose indicator and subject self report of study medication administration.|Week 6|Intent to Treat Population||percentage of devices|||Number
808384|NCT01033825|Secondary|Number of Devices With Major Discrepancies|A major discrepancy is defined as a discrepancy of >20 actuations between the dose indicator and subject self report of study medication administration.|Week 6|Intent to Treat Population||Devices|||Number
808385|NCT01033825|Secondary|Percentage of Devices With Actuation Consistency|Actuation consistency is defined as a dose indicator count within ±20% of the subject self report of study medication administration.|Weeks 1-4|Intent to Treat Population||percentage of devices|||Number
808386|NCT01033825|Secondary|Number of Devices With Actuation Consistency|Actuation consistency is defined as a dose indicator count within ±20% of the subject self report of study medication administration.|Weeks 1-4|Intent to Treat Population||Devices|||Number
808387|NCT01033825|Secondary|Ratio (Percentage) of Correct Advances of the Dose Indicator Out of Expected Advances.|Ratio of correct advance is defined as the (number of doses actuated/number of dose reported).|Weeks 1-2, 2-4|Intent to Treat Population||percentage of correct advances||Standard Deviation|Mean
808388|NCT01033825|Secondary|Time to Maximal Effect Over 6 Weeks of Double-blind Treatment.|The time to maximal effect is defined as the number of days until the first treatment day on which the estimated difference between each active treatment group and corresponding placebo is at least 90% of the largest estimated difference. This is based on the analyses of change from baseline in the average of AM and PM reflective TNSS scores for each day. The evaluation is made separately for each dose level of Ciclesonide HFA compared to placebo. Difference is calculated as placebo - ciclesonide. Analysis of HFA data and AQ data were conducted separately.|Weeks 0-6|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.||Number of days|||Number
808389|NCT01033825|Secondary|Change From Baseline in Daily Subject-reported Individual AM and PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);
= mild
= moderate
= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.||units on a scale||Standard Error|Least Squares Mean
808390|NCT01033825|Secondary|Baseline Daily Subject-reported Individual AM and PM Instantaneous NSS|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);
= mild
= moderate
= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement."|Baseline|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.||units on a scale||Standard Deviation|Mean
808391|NCT01033825|Secondary|Change From Baseline in Daily Subject-reported Individual PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);
= mild
= moderate
= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.||units on a scale||Standard Error|Least Squares Mean
808392|NCT01033825|Secondary|Baseline Daily Subject-reported Individual PM Instantaneous NSS|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);
= mild
= moderate
= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement."|Baseline|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.||units on a scale||Standard Deviation|Mean
808393|NCT01033825|Secondary|Change From Baseline in Daily Subject-reported Individual AM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);
= mild
= moderate
= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.||units on a scale||Standard Error|Least Squares Mean
808394|NCT01033825|Secondary|Baseline Daily Subject-reported Individual AM Instantaneous NSS|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);
= mild
= moderate
= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement."|Baseline|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.||units on a scale||Standard Deviation|Mean
808395|NCT01033825|Secondary|Change From Baseline in Daily Subject-reported Individual AM and PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);
= mild
= moderate
= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.||units on a scale||Standard Error|Least Squares Mean
808396|NCT01033825|Secondary|Baseline Daily Subject-reported Individual AM and PM Reflective NSS|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);
= mild
= moderate
= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement."|Baseline|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.||units on a scale||Standard Deviation|Mean
808397|NCT01033825|Secondary|Change From Baseline in Daily Subject-reported Individual PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);
= mild
= moderate
= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.||units on a scale||Standard Error|Least Squares Mean
808398|NCT01033825|Primary|The Change in Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-24h) From Baseline to Week 6 of the Double Blind Treatment Period|Change is calculated as week 6 minus baseline. AUC(0-24h) will be computed using the linear trapezoidal rule based on the actual time of serum cortisol drawing. AUC(0-24) is then approximated by the sum of the areas of trapezoids. The trapezoid for each time interval is based on the actual times of non-missing cortisol values, and is defined by the actual time interval as the base, the line connecting the two cortisol values, and the two vertical sides at the two time points. Raw data is presented for baseline values (i.e. mean/SD), while inferential statistics are presented for week 6 values (i.e. LS mean/SE).|week 6|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.||mcg•h/dL||Standard Error|Least Squares Mean
808399|NCT01033825|Secondary|Baseline Daily Subject-reported Individual PM Reflective NSS|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);
= mild
= moderate
= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement."|Baseline|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.||units on a scale||Standard Deviation|Mean
808400|NCT01033825|Secondary|Change From Baseline in Daily Subject-reported Individual AM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);
= mild
= moderate
= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.||units on a scale||Standard Error|Least Squares Mean
808401|NCT01033825|Secondary|Baseline Daily Subject-reported Individual AM Reflective NSS|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);
= mild
= moderate
= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement."|Baseline|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.||units on a scale||Standard Deviation|Mean
808402|NCT01033825|Secondary|Change From Baseline in Daily Subject-reported AM and PM Instantaneous TNSS Averaged Over the 6 Weeks of Double-blind Treatment|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.||units on a scale||Standard Error|Least Squares Mean
808482|NCT01033942|Primary|Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 20||Week 20|Not all participants answered every question||participants|||Number
808403|NCT01033825|Secondary|Baseline Daily Subject-reported AM and PM Instantaneous TNSS|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Baseline|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.||units on a scale||Standard Deviation|Mean
808404|NCT01033825|Secondary|Change From Baseline in Daily Subject-reported PM Instantaneous TNSS Averaged Over the 6 Weeks of Double-blind Treatment|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.||units on a scale||Standard Error|Least Squares Mean
808405|NCT01033825|Secondary|Baseline Daily Subject-reported PM Instantaneous TNSS|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Baseline|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.||units on a scale||Standard Deviation|Mean
808406|NCT01033825|Secondary|Change From Baseline in Daily Subject-reported AM and PM Reflective TNSS Averaged Over Each Week, and Averaged Over the 6 Weeks of Double-blind Treatment|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.||units on a scale||Standard Error|Least Squares Mean
808407|NCT01033825|Secondary|Baseline Daily Subject-reported AM and PM Reflective TNSS|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Baseline|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.||units on a scale||Standard Deviation|Mean
808408|NCT01033825|Secondary|Change From Baseline in Daily Subject-reported AM Instantaneous TNSS Averaged Over the 6 Weeks of Double-blind Treatment|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.||units on a scale||Standard Error|Least Squares Mean
808409|NCT01033825|Secondary|Baseline Daily Subject-reported AM Instantaneous TNSS|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Baseline|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.||units on a scale||Standard Deviation|Mean
808410|NCT01033825|Secondary|Change From Baseline in Daily Subject-reported PM Reflective TNSS Averaged Over the 6 Weeks of Double-blind Treatment|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.||units on a scale||Standard Error|Least Squares Mean
808431|NCT01033864|Primary|Dose-Normalized MPA AUC0-12|"Dose-normalized MPA AUC0-12 in plasma was determined (mg*h/L) from blood samples collected predose and postdose on Day 1. Both MMF and EC-MPS doses were normalized to a standard dose of 1 g MMF or 720 mg EC-MPS, respectively. The dose normalization was calculated as follows:
For the MMF group: Dose normalized MPA AUC = MPA AUC / (actual dose taken/1000) For the EC-MPS group: Dose normalized MPA AUC = MPA AUC / (actual dose taken/720)"|Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours|PK population||mg*h/L||Standard Deviation|Mean
808411|NCT01033825|Secondary|Baseline Daily Subject-reported PM Reflective TNSS|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Baseline|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.||units on a scale||Standard Deviation|Mean
808412|NCT01033825|Secondary|Change From Baseline in Daily Subject-reported AM Reflective TNSS Averaged Over the 6 Weeks of Double-blind Treatment|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.||units on a scale||Standard Error|Least Squares Mean
808413|NCT01033825|Secondary|Baseline Daily Subject-reported AM Reflective TNSS|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Baseline|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.||units on a scale||Standard Deviation|Mean
808414|NCT01033825|Secondary|Change in Serum Cortisol Area Under the Concentration-time Curve (AUC)(12-24h) From Baseline After 6 Weeks of Treatment||Weeks 0-6|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.||mcg•h/dL||Standard Error|Least Squares Mean
808415|NCT01033825|Secondary|Serum Cortisol Area Under the Concentration-time Curve (AUC)(12-24h) at Baseline||Baseline|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.||mcg•h/dL||Standard Deviation|Mean
808416|NCT01033825|Secondary|Change in Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-12h) From Baseline After 6 Weeks of Treatment||Weeks 0-6|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.||mcg•h/dL||Standard Error|Least Squares Mean
808417|NCT01033825|Secondary|Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-12h) at Baseline||Baseline|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.||mcg•h/dL||Standard Deviation|Mean
808418|NCT01033825|Secondary|Percentage of Subjects Experiencing Local Nasal AEs|Local Nasal adverse events are defined as adverse events occurring in the middle ear, nose, throat, and upper respiratory tract down to the larynx, anatomic regions.|Weeks 0-6|Intent to Treat Population||percentage of subjects|||Number
808419|NCT01033825|Secondary|Number of Subjects Experiencing Local Nasal AEs|Local Nasal adverse events are defined as adverse events occurring in the middle ear, nose, throat, and upper respiratory tract down to the larynx, anatomic regions.|Weeks 0-6|Intent to Treat Population||participants|||Number
808420|NCT01033825|Secondary|Percentage of Subjects Who Discontinue Due to AEs||Weeks 0-6|Intent to Treat Population||percentage of subjects|||Number
808421|NCT01033825|Secondary|Number of Subjects Who Discontinue Due to AEs||Weeks 0-6|Intent to Treat Population.||participants|||Number
808422|NCT01033825|Secondary|Percentage of Subjects Experiencing Serious Adverse Events (SAEs).||Weeks 0-6|Intent to Treat Population||percentage of subjects|||Number
808423|NCT01033825|Secondary|Number of Subjects Experiencing Serious Adverse Events (SAEs).||Weeks 0-6|Intent to Treat Population.||participants|||Number
808424|NCT01033825|Secondary|Percentage of Subjects Experiencing Adverse Events (AEs)||Weeks 0-6|Intent to Treat Population.||percentage of subjects|||Number
808425|NCT01033825|Secondary|Number of Subjects Experiencing Adverse Events (AEs)||Weeks 0-6|Intent to Treat Population.||participants|||Number
808426|NCT01033825|Primary|Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-24h) at Baseline|AUC(0-24h) will be computed using the linear trapezoidal rule based on the actual time of serum cortisol drawing. AUC(0-24) is then approximated by the sum of the areas of trapezoids. The trapezoid for each time interval is based on the actual times of non-missing cortisol values, and is defined by the actual time interval as the base, the line connecting the two cortisol values, and the two vertical sides at the two time points. Raw data is presented for baseline values (i.e. mean/SD), while inferential statistics are presented for week 6 values (i.e. LS mean/SE).|Baseline|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.||mcg•h/dL||Standard Deviation|Mean
808427|NCT01033851|Secondary|Clinical Global Impression of Severity (CGIS) of Anxiety Symptoms.|This is an overal clinical measure of anxiety symptoms after examining and interviewing the patient. The scale is one global item, that scores from 1 (1= not ill at all) to 7 (7= among the most extremely ill).|2 months|The population analyzed included all participants attending at least one class of an intervention.||units on a scale||Standard Deviation|Mean
808428|NCT01033851|Primary|Active Symptoms of Generalized Anxiety Disorder|The Hamilton Anxiety Scale (HAMA) was defined as the primary anxiety outcome variable. This scale has 14 items describing symptoms of anxiety, each answered on a 0-4 scale, with 0 for a single question generally representing no symptoms, and 4 representing severe levels of the symptom. The total score is calculated by adding all the items together, for a possible total score of 0 to 56.|2 months|The population analyzed included all participants who attended at least one class of an intervention.||units on a scale||Standard Deviation|Mean
808483|NCT01033942|Primary|Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 16||Week 16|Not all participants answered every question||participants|||Number
808433|NCT01033864|Primary|Dose-Normalized Cmax (mg/L)|"Dose-normalized Cmax in plasma was determined (in mg/L) from blood samples collected predose and postdose on Day 1. Both MMF and EC-MPS doses were normalized to a standard dose of 1 g MMF or 720 mg EC-MPS, respectively. The dose normalization was calculated as follows:
For the MMF group: Dose normalized Cmax = Cmax / (actual dose taken/1000) For the EC-MPS group: Dose normalized Cmax = Cmax / (actual dose taken/720)"|Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours|PK population||mg/L||Standard Deviation|Mean
808434|NCT01033864|Primary|Maximum Plasma Concentration (Cmax)|The mean maximum MPA concentration in plasma was determined (in mg/L) in blood samples collected predose and postdose on Day 1.|Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours|PK population||mg/L||Standard Deviation|Mean
808435|NCT01033864|Primary|Dose-Normalized Cmin|"Dose-normalized Cmin was determined (in mg/L) from blood samples collected predose and postdose. Both MMF and EC-MPS doses were normalized to a standard dose of 1 g MMF or 720 mg EC-MPS, respectively. The dose normalization was calculated as follows:
For the MMF group: Dose normalized Cmin = Cmin/ (actual dose taken/1000) For the EC-MPS group: Dose normalized Cmin = Cmin / (actual dose taken/720)"|Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours|PK population||mg/L||Standard Deviation|Mean
808436|NCT01033864|Primary|Minimum Plasma Concentration (Cmin)|The mean minimum MPA concentration in plasma was determined (in mg/L) from blood samples collected predose and postdose on Day 1.|Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours|PK population||mg/L||Standard Deviation|Mean
808437|NCT01033864|Primary|Dose-Normalized C0|"Dose normalized C0 was determined (in mg/L) from blood samples collected predose. Both MMF and EC-MPS doses were normalized to a standard dose of 1 g MMF or 720 mg EC-MPS, respectively. The dose normalization was calculated as follows:
For the MMF group: Dose normalized C0 equals (=) C0 divided by (/) (actual dose taken/1000) For the EC-MPS group: Dose normalized C0 = C0 / (actual dose taken/720)"|Day 1 predose|PK population||mg/L||Standard Deviation|Mean
808438|NCT01033864|Primary|Pre-dose Trough Concentration (C0)|The mean mycophenolic acid (MPA) concentration in plasma was determined (in milligrams per liter [mg/L]) from blood samples collected predose (immediately before receiving study treatment).|Day 1 predose|Pharmacokinetic (PK) population: all participants who took study drug and for whom all defined blood samples at the planned sampling time points were available.||mg/L||Standard Deviation|Mean
808439|NCT01033942|Secondary|Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 24|"A high-risk sex act was defined as an answer of greater than 0 to any of the following questions:
With your male HIV positive male partners during the past month:
How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom?"|Week 24|Not all participants answered every question||participants|||Number
808440|NCT01033942|Secondary|Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 20|"A high-risk sex act was defined as an answer of greater than 0 to any of the following questions:
With your male HIV positive male partners during the past month:
How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom?"|Week 20|Not all participants answered every question||participants|||Number
808441|NCT01033942|Secondary|Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 16|"A high-risk sex act was defined as an answer of greater than 0 to any of the following questions:
With your male HIV positive male partners during the past month:
How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom?"|Week 16|Not all participants answered every question.||participants|||Number
808442|NCT01033942|Secondary|Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 12|"A high-risk sex act was defined as an answer of greater than 0 to any of the following questions:
With your male HIV positive male partners during the past month:
How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom?"|Week 12|Not all participants answered every question.||participants|||Number
808443|NCT01033942|Secondary|Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 8|"A high-risk sex act was defined as an answer of greater than 0 to any of the following questions:
With your male HIV positive male partners during the past month:
How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom?"|Week 8|Not all participants answered every question||participants|||Number
808444|NCT01033942|Secondary|Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 4|"A high-risk sex act was defined as an answer of greater than 0 to any of the following questions:
With your male HIV positive male partners during the past month:
How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom?"|Week 4|Not all participants answered every question||participants|||Number
808445|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 24: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study|Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: “I have already risked getting infected with HIV through unsafe sex while I’ve been in this study.”|Week 24|Not all participants answered every question||percentage of participants|||Number
808446|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 20: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study|Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: “I have already risked getting infected with HIV through unsafe sex while I’ve been in this study.”|Week 20|Not all participants answered every question||percentage of participants|||Number
808447|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 16: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study|Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: “I have already risked getting infected with HIV through unsafe sex while I’ve been in this study.”|Week 16|Not all participants answered every question||percentage of participants|||Number
808448|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 12: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study|Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: “I have already risked getting infected with HIV through unsafe sex while I’ve been on this study.”|Week 12|Not all participants answered every question||percentage of participants|||Number
808449|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 8: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study|Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: “I have already risked getting infected with HIV through unsafe sex while I’ve been in this study.”|Week 8|Not all participants answered every question||percentage of participants|||Number
808450|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 4: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study|Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: “I have already risked getting infected with HIV through unsafe sex while I’ve been in this study.”|Week 4|Not all participants answered every question||percentage of participants|||Number
808451|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 24: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study|Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: “I am less concerned about having unprotected anal sex now that I am in this PrEP study.”|Week 24|Not all participants answered every question||percentage of participants|||Number
808452|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 20: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study|Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: “I am less concerned about having unprotected anal sex now that I am in this PrEP study.”|Week 20|Not all participants answered every question||percentage of participants|||Number
808453|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 16: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study|Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: “I am less concerned about having unprotected anal sex now that I am in this PrEP study.”|Week 16|Not all participants answered every question||percentage of participants|||Number
808454|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 12: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study|Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: “I am less concerned about having unprotected anal sex now that I am in this PrEP study.”|Week 12|Not all participants answered every question||percentage of participants|||Number
808455|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 8: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study|Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: “I am less concerned about having unprotected anal sex now that I am in this PrEP study.”|Week 8|Not all participants answered every question||percentage of participants|||Number
808456|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 4: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study|Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: “I am less concerned about having unprotected anal sex now that I am in this PrEP study.”|Week 4|Not all participants answered every question||percentage of participants|||Number
808457|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 24: Less Worried About Having Unprotected Sex Due to the Availability of PrEP|Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: “The availability of PrEP makes me less worried about having unprotected sex.”|Week 24|Not all participants answered every question||percentage of participants|||Number
808458|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 20: Less Worried About Having Unprotected Sex Due to the Availability of PrEP|Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: “The availability of PrEP makes me less worried about having unprotected sex.”|Week 20|Not all participants answered every question||percentage of participants|||Number
808459|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 16: Less Worried About Having Unprotected Sex Due to the Availability of PrEP|Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: “The availability of PrEP makes me less worried about having unprotected sex.”|Week 16|Not all participants answered every question||percentage of participants|||Number
808460|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 12: Less Worried About Having Unprotected Sex Due to the Availability of PrEP|Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: “The availability of PrEP makes me less worried about having unprotected sex.”|Week 12|Not all participants answered every question||percentage of participants|||Number
808461|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 8: Less Worried About Having Unprotected Sex Due to the Availability of PrEP|Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: “The availability of PrEP makes me less worried about having unprotected sex.”|Week 8|Not all participants answered every question||percentage of participants|||Number
808484|NCT01033942|Primary|Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 12||Week 12|Not all participants answered every question||participants|||Number
808464|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 20: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex|Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: “I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex.”|Week 20|Not all participants answered every question||percentage of participants|||Number
808465|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 16: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex|Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: “I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex.”|Week 16|Not all participants answered every question||percentage of participants|||Number
808466|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 12: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex|Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: “I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex.”|Week 12|Not all participants answered every question||percentage of participants|||Number
808467|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 8: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex|Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: “I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex.”|Week 8|Not all participants answered every question||percentage of participants|||Number
808468|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 4: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex|Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: “I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex.”|Week 4|Not all participants answered every question||percentage of participants|||Number
808469|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 24: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study|"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am more willing to take a chance of getting infected now that I am in this PrEP study."|Week 24|Not all participants answered every question||percentage of participants|||Number
808470|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 20: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study|"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am more willing to take a chance of getting infected now that I am in this PrEP study."|Week 20|Not all participants answered every question||percentage of participants|||Number
808471|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 16: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study|"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am more willing to take a chance of getting infected now that I am in this PrEP study."|Week 16|Not all participants answered every question||percentage of participants|||Number
808472|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 12: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study|"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am more willing to take a chance of getting infected now that I am in this PrEP study."|Week 12|Not all participants answered every question||percentage of participants|||Number
808473|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 8: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study|"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am more willing to take a chance of getting infected now that I am in this PrEP study."|Week 8|Not all participants answered every question||percentage of participants|||Number
808474|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 4: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study|"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am more willing to take a chance of getting infected now that I am in this PrEP study."|Week 4|Not all participants answered every question||percentage of participants|||Number
808475|NCT01033942|Primary|Perceived Risk of Becoming HIV Positive at Week 24|"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: Because I am in this PrEP study, I am less concerned about becoming HIV positive."|Week 24|Not all participants answered every question||percentage of participants|||Number
808476|NCT01033942|Primary|Perceived Risk of Becoming HIV Positive at Week 20|"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: Because I am in this PrEP study, I am less concerned about becoming HIV positive."|Week 20|Not all participants answered every question||percentage of participants|||Number
808477|NCT01033942|Primary|Perceived Risk of Becoming HIV Positive at Week 16|"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: Because I am in this PrEP study, I am less concerned about becoming HIV positive."|Week 16|Not all participants answered every question||percentage of partcipants|||Number
808478|NCT01033942|Primary|Perceived Risk of Becoming HIV Positive at Week 12|"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: Because I am in this PrEP study, I am less concerned about becoming HIV positive."|Week 12|Not all participants answered every question||percentage of participants|||Number
808479|NCT01033942|Primary|Perceived Risk of Becoming HIV Positive at Week 8|"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: Because I am in this PrEP study, I am less concerned about becoming HIV positive."|Week 8|Not all participants answered every question||percentage of participants|||Number
808488|NCT01033942|Primary|Frequency of Missing Study Pills Because Participant Ran Out of Study Pills||24 weeks|Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.||% of participants in each category|||Number
808489|NCT01033942|Primary|Frequency of Missing Study Pills Because Participant Felt Depressed/Overwhelmed||24 weeks|Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.||% of participants in each category|||Number
808490|NCT01033942|Primary|Frequency of Missing Study Pills Because Participant Felt Sick or Ill||24 weeks|Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.||% of participants in each category|||Number
808491|NCT01033942|Primary|Frequency of Missing Study Pills Because Participant Fell Asleep/Slept Through Dose Time||24 weeks|Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.||% of participants in each category|||Number
808492|NCT01033942|Primary|Frequency of Missing Pills Because Participant Felt Like the Study Pill Was Toxic/Harmful||24 weeks|Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.||% of participants in each category|||Number
808493|NCT01033942|Primary|Frequency of Missing Study Pills Because Participant Had a Change in Daily Routine||24 weeks|Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.||% of participants in each category|||Number
808494|NCT01033942|Primary|Frequency of Missing Study Pills Because Participant Did Not Want Others to Notice Participant Was Taking Medications||24 weeks|Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.||% of participants in each category|||Number
808495|NCT01033942|Primary|Frequency of Missing Study Pills Because Participant Wanted to Avoid Side Effects||24 weeks|Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.||% of participants in each category|||Number
808496|NCT01033942|Primary|Frequency of Missing Study Pills Because Participant Had Too Many Study Pills to Take||24 weeks|Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.||% of participants in each category|||Number
808497|NCT01033942|Primary|Frequency of Missing Study Pills Because Participant Simply Forgot||24 Weeks|Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.||% of participants in each category|||Number
808498|NCT01033942|Primary|Frequency of Missing Study Pills Because Participant Was Too Busy With Other Things||24 Weeks|Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.||% of participants in each category|||Number
808499|NCT01033942|Primary|Frequency of Missing Study Pills Because Participant Was Away From Home||24 Weeks|Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.||% of participants in each category|||Number
808500|NCT01033942|Primary|Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 24|Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (<10 ng/mL) were included in this count.|Week 24|No subjects in the Placebo Pill Control arm were randomly selected for tenofovir plasma concentration testing at Week 24. 10 subjects in the FTC/TDF as PrEP arm had tenofovir plasma concentration testing and no subjects in the No Pill arm had tenofovir plasma concentration testing at Week 24.||percentage of participants|||Number
808501|NCT01033942|Primary|Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 20|Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (<10 ng/mL) were included in this count.|Week 20|One subject in the Placebo Pill Control arm was randomly selected for tenofovir plasma concentration testing at Week 20. 12 subjects in the FTC/TDF as PrEP arm had tenofovir plasma concentration testing and no subjects in the No Pill arm had tenofovir plasma concentration testing at Week 20.||percentage of participants|||Number
808502|NCT01033942|Primary|Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 16|Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (<10 ng/mL) were included in this count.|Week 16|13 subjects in the Placebo Pill Control arm were randomly selected for tenofovir plasma concentration testing at Week 16. 13 subjects in the FTC/TDF as PrEP arm had tenofovir plasma concentration testing and 14 subjects in the No Pill arm had tenofovir plasma concentration testing at Week 16.||percentage of participants|||Number
808503|NCT01033942|Primary|Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 12|Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (<10 ng/mL) were included in this count.|Week 12|One subject in the Placebo Pill Control arm was randomly selected for tenofovir plasma concentration testing at Week 12. 15 subjects in the FTC/TDF as PrEP arm had tenofovir plasma concentration testing and 1 subject in the No Pill arm had tenofovir plasma concentration testing at Week 12.||percentage of participants|||Number
808504|NCT01033942|Primary|Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 8|Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (<10 ng/mL) were included in this count.|Week 8|18 subjects in the Placebo Pill Control arm were randomly selected for tenofovir plasma concentration testing at Week 8. 17 subjects in the FTC/TDF as PrEP arm had tenofovir plasma concentration testing and 17 subjects in the No Pill arm had tenofovir plasma concentration testing at Week 8.||percentage of participants|||Number
808505|NCT01033942|Primary|Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 4|Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (<10 ng/mL) were included in this count.|Week 4|Only two subjects in the Placebo Pill Control arm were randomly selected for tenofovir plasma concentration testing at Week 4. 19 subjects in the FTC/TDF as PrEP arm had tenofovir plasma concentration testing and no subjects in the No Pill arm had tenofovir plasma concentration testing at Week 4.||percentage of participants|||Number
808506|NCT01033942|Primary|Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Baseline|Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (<10 ng/mL) were included in this count.|Baseline|Only two subjects in the Placebo Pill Control arm were randomly selected for tenofovir plasma concentration testing at baseline. All subjects in the FTC/TDF as PrEP arm had tenofovir plasma concentration testing and no subjects in the No Pill arm had tenofovir plasma concentration testing at baseline.||percentage of participants|||Number
808507|NCT01033942|Primary|Number of Missed Doses Based on Medication Refill Dates-Overall|Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.|20 Weeks|||Missed doses||Full Range|Median
808508|NCT01033942|Primary|Number of Missed Doses Based on Medication Refill Dates-Week 20|Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.|Week 20|||Missed doses||Full Range|Median
808509|NCT01033942|Primary|Number of Missed Doses Based on Medication Refill Dates-Week 16|Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.|Week 16|||Missed doses||Full Range|Median
808510|NCT01033942|Primary|Number of Missed Doses Based on Medication Refill Dates-Week 12|Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.|Week 12|||Missed doses||Full Range|Median
808511|NCT01033942|Primary|Number of Missed Doses Based on Medication Refill Dates-Week 8|Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.|Week 8|||Missed doses||Full Range|Median
808512|NCT01033942|Primary|Number of Missed Doses Based on Medication Refill Dates-Week 4|Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.|Week 4|||Missed doses||Full Range|Median
808513|NCT01033942|Primary|Number of Missed Doses Over Time Based on Self-Report Calendar Data|The outcome measure presents the least square means from the generalized linear model. The outcome here is a binary variable that determines whether the subject missed a dose or not. In a binomial model with logit link, the least squares means are predicted population margins of the logits.|24 weeks|||Doses||Standard Error|Least Squares Mean
808514|NCT01033942|Primary|Number of Missed Doses Based on Self-Report Calendar Data-Week 24|Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.|Week 24|||Missed Doses||Full Range|Median
808515|NCT01033942|Primary|Number of Missed Doses Based on Self-Report Calendar Data-Week 20|Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.|Week 20|||Missed Doses||Full Range|Median
808516|NCT01033942|Primary|Number of Missed Doses Based on Self-Report Calendar Data-Week 16|Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.|Week 16|||Missed Doses||Full Range|Median
808517|NCT01033942|Primary|Number of Missed Doses Based on Self-Report Calendar Data-Week 12|Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.|Week 12|||Missed Doses||Full Range|Median
808518|NCT01033942|Primary|Number of Missed Doses Based on Self-Report Calendar Data-Week 8|Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.|Week 8|||Missed Doses||Full Range|Median
808519|NCT01033942|Primary|Number of Missed Doses Based on Self-Report Calendar Data-Week 4|Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.|4 weeks|||Missed Doses||Full Range|Median
808520|NCT01033942|Primary|Acceptability of Health Clinic for Study Visits||Week 24|Not all participants answered every question.||participants|||Number
808521|NCT01033942|Primary|Acceptability of Physical Examination by a Doctor||Week 24|Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.||participants|||Number
808522|NCT01033942|Primary|Acceptability of Being Contacted by the Research Team in Between Visits||Week 24|Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.||participants|||Number
808523|NCT01033942|Primary|Acceptability of Questions About Sexual Behavior at Every Visit||Week 24|Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.||participants|||Number
808524|NCT01033942|Primary|Acceptability of Risk Reduction Counseling at Every Visit||Week 24|Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.||participants|||Number
808525|NCT01033942|Primary|Acceptability of Having an HIV Test at Every Visit||Week 24|Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.||participants|||Number
808526|NCT01033942|Primary|Acceptability of Being Randomly Assigned to a Group||Week 24|Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.||participants|||Number
808527|NCT01033942|Primary|Acceptability of Participating in Group Sessions||Week 24|Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.||participants|||Number
808528|NCT01033942|Primary|Acceptability of Taking Part in the Study||Week 24|Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.||participants|||Number
808529|NCT01033942|Primary|Acceptability of Taking the Pill Everyday||Week 24|Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.||participants|||Number
808530|NCT01033942|Primary|Acceptability of the Color of the Pill||Week 24|Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.||participants|||Number
808531|NCT01033942|Primary|Acceptability of the Taste of the Pill||Week 24|Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.||participants|||Number
808532|NCT01033942|Primary|Acceptability of Size of Pill||Week 24|Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.||Participants|||Number
808533|NCT01033942|Secondary|Number of Participants Reporting No High-Risk Man With Man Sex Acts at Baseline|"A high-risk sex act was defined as an answer of greater than 0 to any of the following questions:
With your male HIV positive male partners during the past month:
How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom?"|Baseline|||participants|||Number
808534|NCT01033942|Primary|Actual Number of Study Visits Completed by 24 Weeks|This outcome measure looked at whether the actual number of study visits conducted by 24 weeks differed by treatment group over time.|24 weeks|||Visits||Standard Error|Least Squares Mean
808535|NCT01034111|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 4|Calculated as the mean change from baseline in fasting plasma glucose at Week 4.|Baseline and Week 4|||mmol/L||Standard Deviation|Mean
808536|NCT01034111|Primary|Safety and Tolerability of Sitagliptin After 4 Weeks of Treatment|Safety & tolerability were measured in terms of the # of participants with >=1 adverse event (AE), >=1 drug-related AE, >=1 serious AE (SAE), or discontinued treatment due to an AE. SAEs included events occurring after initiation of glycemic rescue therapy. AE is defined as any unfavorable/unintended change in structure, function, or chemistry of the body temporally associated with the use of SPONSOR’s product. SAE is defined as any AE that results in death, is life-threatening, an overdose, causes or prolongs in-patient hospitalization, or considered medically significant by the investigator.|4 weeks|||Participants|||Number
808537|NCT01034137|Secondary|Number of Participants With Clinically Significant Laboratory Values at Week 104|Laboratory parameters included hematology, chemistry and lipids. Any treatment-emergent abnormal laboratory result accompanied by clinical symptoms or leading to a change in study medication or requiring a change in concomitant therapy was considered clinically significant. Participants with clinically significant laboratory values are reported in the below table.|Week 104|The safety population consisted of all participants who received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and have at least one post-baseline safety assessment. n = number of participants evaluable at particular time of assessment.||Number of participants|||Number
808601|NCT01034397|Secondary|Change From Baseline to Week 12 in Erythrocyte Sedimentation Rate (ESR)|ESR is an inflammatory marker and is used to assess disease activity in rheumatoid arthritis (RA). A reduction in ESR indicates improvement.|Week 12|ITT population. After Week 12, participants receiving placebo could have been switched to tocilizumab.||mm/hr||Full Range|Median
808677|NCT01034657|Secondary|Time to Response - Overall Period|Time to response was defined as the time from start of treatment to the first documented response (complete [CR] or partial [PR]) according to modified IWG criteria for HI.|52 weeks|Time to response could not be evaluated because there was no response.|||||
808538|NCT01034137|Secondary|Number of Participants With Clinically Significant Laboratory Values at Week 52|Laboratory parameters included hematology, chemistry and lipids. Any treatment-emergent abnormal laboratory result accompanied by clinical symptoms or leading to a change in study medication or requiring a change in concomitant therapy was considered clinically significant. Participants with clinically significant laboratory values are reported in the below table.|Week 52|The safety population consisted of all participants who received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and have at least one post-baseline safety assessment. n = number of participants evaluable at particular time of assessment.||Number of participants|||Number
808539|NCT01034137|Secondary|Number of Participants With Clinically Significant Laboratory Values at Week 24|Laboratory parameters included hematology, chemistry and lipids. Any treatment-emergent abnormal laboratory result accompanied by clinical symptoms or leading to a change in study medication or requiring a change in concomitant therapy was considered clinically significant. Participants with clinically significant laboratory values are reported in the below table.|Week 24|The safety population consisted of all participants who received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and have at least one post-baseline safety assessment. n = number of participants evaluable at particular time of assessment.||Number of participants|||Number
808540|NCT01034137|Secondary|Number of Participants With Clinically Significant Laboratory Values at Week 12|Laboratory parameters included hematology, chemistry and lipids. Any treatment-emergent abnormal laboratory result accompanied by clinical symptoms or leading to a change in study medication or requiring a change in concomitant therapy was considered clinically significant. Participants with clinically significant laboratory values are reported in the below table.|Week 12|The safety population consisted of all participants who received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and have at least one post-baseline safety assessment. n = number of participants evaluable at particular time of assessment.||Number of participants|||Number
808541|NCT01034137|Secondary|Number of Participants With Any Adverse Events, Any Serious Adverse Events, and Adverse Events Leading to Discontinuation|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. A serious adverse event is defined as any event which was fatal (resulted in death), lifethreatening (with immediate risk of death), resulted in a new or prolongation of a current hospitalization, resulted in persistent or significant disability or incapacity, was a congenital anomaly or birth defect, considered medically significant by the investigator, required intervention to prevent one or more of the outcomes listed above.|Up to Week 104|The safety population consisted of all participants who received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and have at least one post-baseline safety assessment.||Number of participants|||Number
808542|NCT01034137|Secondary|Mean Change From Baseline in The IPQ-R Score of Quality of Life at Week 104|The IPQ-R includes 9 domains (identity, acute or chronic timeline, consequences, personal and treatment control, illness coherence, timeline cyclical, emotional representations, and cause). For first 8 domains it scores as: 1(strongly disagree), 2(disagree), 3(neither agree/disagree), 4(agree), and 5(strongly agree), except identity as 1(yes) and 0(no). The sum of scores for identity, timeline, consequences, and cyclical domains are ranged from 0-16. High score represent strongly held beliefs about the number of symptoms attributed to RA, the chronicity of the condition, the negative consequences of the illness and the cyclical nature of the condition. The sum of scores for personal and treatment control, coherence dimensions, and emotional representations are ranged from 0-15. High score represent positive beliefs about the number of controllability of RA and a personal understanding of the condition. The data for ‘Cause’ domain was not considered for analysis in this study.|From Baseline (Week 0) to Week 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.||Scores on a scale||Standard Deviation|Mean
808543|NCT01034137|Secondary|Mean Change From Baseline in The IPQ-R Score of Quality of Life at Week 52|The IPQ-R includes 9 domains (identity, acute or chronic timeline, consequences, personal and treatment control, illness coherence, timeline cyclical, emotional representations, and cause). For first 8 domains it scores as: 1(strongly disagree), 2(disagree), 3(neither agree/disagree), 4(agree), and 5(strongly agree), except identity as 1(yes) and 0(no). The sum of scores for identity, timeline, consequences, and cyclical domains are ranged from 0-16. High score represent strongly held beliefs about the number of symptoms attributed to RA, the chronicity of the condition, the negative consequences of the illness and the cyclical nature of the condition. The sum of scores for personal and treatment control, coherence dimensions, and emotional representations are ranged from 0-15. High score represent positive beliefs about the number of controllability of RA and a personal understanding of the condition. The data for ‘Cause’ domain was not considered for analysis in this study.|From Baseline (Week 0) to Week 52|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.||Scores on a scale||Standard Deviation|Mean
808551|NCT01034137|Secondary|Mean Change From Baseline in 36-Item Short Form Health Survey of Quality of Life at Weeks 12, 24, 52, and 104|The 36-Item Short Form Health Survey (SF-36) is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical Component Summary (PCS) and Mental Component Summary (MCS) measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from baseline indicates improvement.|From Baseline (Week 0) to Weeks 12, 24, 52 and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.||Scores on a scale||Standard Deviation|Mean
822944|NCT01165983|Secondary|Absolute Change in Biochemical Markers of Endothelial Function, sVCAM-1, ng/mL||12 Weeks post-randomization|||ng/mL||Inter-Quartile Range|Median
808544|NCT01034137|Secondary|Mean Change From Baseline in The IPQ-R Score of Quality of Life at Week 24|The IPQ-R includes 9 domains (identity, acute or chronic timeline, consequences, personal and treatment control, illness coherence, timeline cyclical, emotional representations, and cause). For first 8 domains it scores as: 1(strongly disagree), 2(disagree), 3(neither agree/disagree), 4(agree), and 5(strongly agree), except identity as 1(yes) and 0(no). The sum of scores for identity, timeline, consequences, and cyclical domains are ranged from 0-16. High score represent strongly held beliefs about the number of symptoms attributed to RA, the chronicity of the condition, the negative consequences of the illness and the cyclical nature of the condition. The sum of scores for personal and treatment control, coherence dimensions, and emotional representations are ranged from 0-15. High score represent positive beliefs about the number of controllability of RA and a personal understanding of the condition. The data for ‘Cause’ domain was not considered for analysis in this study.|From Baseline (Week 0) to Week 24|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.||Scores on a scale||Standard Deviation|Mean
808545|NCT01034137|Secondary|Mean Change From Baseline in The Revised Illness Perception Questionnaire (IPQ-R) Score of Quality of Life at Week 12|The IPQ-R includes 9 domains (identity, acute or chronic timeline, consequences, personal and treatment control, illness coherence, timeline cyclical, emotional representations, and cause). For first 8 domains it scores as: 1(strongly disagree), 2(disagree), 3(neither agree/disagree), 4(agree), and 5(strongly agree), except identity as 1(yes) and 0(no). The sum of scores for identity, timeline, consequences, and cyclical domains are ranged from 0-16. High score represent strongly held beliefs about the number of symptoms attributed to RA, the chronicity of the condition, the negative consequences of the illness and the cyclical nature of the condition. The sum of scores for personal and treatment control, coherence dimensions, and emotional representations are ranged from 0-15. High score represent positive beliefs about the number of controllability of RA and a personal understanding of the condition. The data for ‘Cause’ domain was not considered for analysis in this study.|From Baseline (Week 0) to Week 12|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.||Scores on a scale||Standard Deviation|Mean
808546|NCT01034137|Secondary|Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue Score of Quality of Life at Weeks 12, 24, 52, and 104|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participants response to the questions (with the exception of 2 negatively stated), the greater the participants fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant’s response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the participant’s health status.|From Baseline (Week 0) to Weeks 12, 24, 52 and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.||Scores on a scale||Standard Deviation|Mean
808547|NCT01034137|Secondary|Mean Change From Baseline in Patient General Wellbeing Visual Analog Scale Score of Quality of Life at Weeks 12, 24, 52, and 104|"Participants assessed their general wellbeing using a 0 to 10 horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 and is described as  not active at all  and the right-hand extreme equals 10 as  very active  .The final VAS score will be derived by multiplying the original scores by 10."|From Baseline (Week 0) to Weeks 12, 24, 52 and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.||Scores on a scale||Standard Deviation|Mean
808548|NCT01034137|Secondary|Mean Change From Baseline in Patient Pain Visual Analog Scale Score of Quality of Life at Weeks 12, 24, 52, and 104|"Participants assessed their pain using a 0 to 10 horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 and is described as no pain and the right-hand extreme equals 10 as unbearable pain .The final VAS score will be derived by multiplying the original scores by 10."|From Baseline (Week 0) to Weeks 12, 24, 52 and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.||Scores on a scale||Standard Deviation|Mean
808549|NCT01034137|Secondary|Mean Change From Baseline in Physician Global Health Visual Analog Scale Score of Quality of Life at Weeks 12, 24, 52, and 104|Physician global health VAS score ranges from 0 to 100 and a higher score indicates worse QoL. Physician global health VAS is a component of DAS28.|From Baseline (Week 0) to Weeks 12, 24, 52 and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.||Scores on a scale||Standard Deviation|Mean
808550|NCT01034137|Secondary|Mean Change From Baseline in Patient Global Health Visual Analog Scale Score of Quality of Life at Weeks 12, 24, 52, and 104|Patient global health VAS score ranges from 0 to 100 and a higher score indicates worse QoL. Patient global health VAS is a component of DAS28.|From Baseline (Week 0) to Weeks 12, 24, 52 and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.||Scores on a scale||Standard Deviation|Mean
808593|NCT01034397|Secondary|Change From Baseline to Week 12 in Serum Androstenedione|Change in serum androstenedione was determined as the difference in the scores at Baseline and Week 12.|Week 12|ITT population||mg/dL||Full Range|Median
808594|NCT01034397|Secondary|Change From Baseline to Week 24 in Plasma ACTH|Change in plasma ACTH was determined as the difference in the scores at baseline and Week 24.|Week 24|ITT population||mg/dL||Full Range|Median
808552|NCT01034137|Secondary|Mean Change From Baseline in The EuroQol Score of Quality of Life at Weeks 12, 24, 52 and 104|"EuroQol (EQ-5D) is a standard self-completed participant questionnaire that measures health outcome. The EQ-5D questionnaire consists of 2 parts: 1) EQ-5D with five dimensions: mobility, self-care, usual activities, pain / discomfort, and anxiety / depression. Each dimension is rated on a 3-point response scale as 1 = no problems, 2 = some/moderate problems, 3 = extreme problems. The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, where ‘1’ indicating full health and ‘0’ representing dead. The positive values indicate that during the study the health status improved. 2) EQ-VAS on a scale of 0 to 100, where 0 = worst possible health status and 100 = best possible health status.”"|From Baseline (Week 0) to Weeks 12, 24, 52 and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.||Scores on a scale||Standard Deviation|Mean
808553|NCT01034137|Secondary|Mean Change From Baseline in The Dutch Consensus Health Assessment Questionnaire of Quality of Life at Weeks 12, 24, 52, and 104|The Dutch Consensus Health Assessment Questionnaire (DC-HAQ) disability index is a self-completed participant questionnaire with 8 domains specific for RA. It assesses a participant functional ability, with scores ranging from 0 (without any difficulty) to 3 (unable to do). A change from baseline of –0.22 is considered to be the minimal clinically important difference.|From Baseline (Week 0) to Weeks 12, 24, 52 and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.||Scores on a scale||Standard Deviation|Mean
808554|NCT01034137|Secondary|Number of Participants With Change in The Therapy Strategy During The Study|Participants who switched treatment strategy from monotherapy (TCZ+ placebo MTX or MTX+ placebo TCZ treatment) to combination therapy (TCZ+MTX treatment) was reported. Also, participants who switched from verum therapy to standard of care was reported in the below table.|From Baseline to Week 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement.||Number of participants|||Number
808555|NCT01034137|Secondary|Percentage of Participants Who Withdraw Due to Lack of Sufficient Therapeutic Response|Insufficient therapeutic response (participants not responding to the drug as assessed by the physician) was selected by the investigator as a reason for the participant to withdraw from the study.|Up to Week 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement.||Percentage of participants|||Number
808556|NCT01034137|Secondary|Mean Change From Baseline in Modified Sharp/Van Der Heijde Score at Weeks 52 and 104|The degree of joint damage was assessed using the van der Heijde modified total Sharp score (mTSS). The methodology quantifies the extent of bone erosions for 44 joints and joint space narrowing (JSN) for 42 joints, with higher scores representing greater damage. The independent read of X-ray images was performed by 2 primary readers. In case of discrepancy between the 2 primary readers, an adjudicator was involved. The mTSS can range from 0 to 448 with a higher score indicating more joint damage. A negative change score indicates improvement.|From Baseline (Week 0) to Weeks 52 and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement.||Scores on a scale||Standard Deviation|Mean
808557|NCT01034137|Secondary|Mean Percent Change From Baseline in CRP at Weeks 12, 24, 52, and 104|CRP is a component of ACR. CRP is a marker of inflammation.|From Baseline (Week 0) to Weeks 12, 24, 52, and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.||Percent change||Standard Deviation|Mean
808558|NCT01034137|Secondary|Mean Percent Change From Baseline in Pain Visual Analog Scale at Weeks 12, 24, 52, and 104|Pain VAS is a component of ACR. VAS pain score calculated as 0 to 10 cm; where 0 = no pain, and 10 = worst possible pain.|From Baseline (Week 0) to Weeks 12, 24, 52, and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.||Percent change||Standard Deviation|Mean
808559|NCT01034137|Secondary|Mean Percent Change From Baseline in The Physician Health Visual Analog Scale at Weeks 12, 24, 52, and 104|Physician health visual analog scale is a component of ACR. It is measured using a visual analogue scale with scores ranging from 0 to 100 (higher scores indicate worse disease activity).An improvement (decrease) in the physician’s global assessment based on disease activity parameter relative to respective baseline values was analyzed.|From Baseline (Week 0) to Weeks 12, 24, 52, and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.||Percent change||Standard Deviation|Mean
808560|NCT01034137|Secondary|Mean Percent Change From Baseline in Patient Health Visual Analog Scale at Weeks 12, 24, 52, and 104|Patient health visual analog scale is a component of ACR. It is measured using a visual analogue scale with scores ranging from 0 to 100 (higher scores indicate worse disease activity). An improvement (decrease) in the patient’s global assessment based on disease activity relative to respective baseline values was analyzed.|From Baseline (Week 0) to Weeks 12, 24, 52, and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment||Percent change||Standard Deviation|Mean
808595|NCT01034397|Secondary|Change From Baseline to Week 12 in Plasma Adrenocorticotrophic Hormone (ACTH)|Change in Plasma ACTH was determined as the difference in the scores at Baseline and Week 12.|Week 12|ITT population||mg/dL||Full Range|Median
808596|NCT01034397|Secondary|Change From Baseline to Week 24 in Serum Cortisol|Change in serum cortisol was determined as the difference in the scores at Baseline and Week 24.|Week 24|ITT population;||mg/dL||Full Range|Median
808561|NCT01034137|Secondary|Mean Percent Change From Baseline in the Tender Joint Count (TJC) at Weeks 12, 24, 52, and 104|The number of tender joints among 22 anatomical joints for both the right and left side of the body were assessed by a joint evaluator where the presence of a tender joint was scored as 1 and absence as 0. The total TJC was derived by the sum of the scores for a range of TJC from 0 (best possible score; no tender joints) to 44 (worse possible score; all tender joints).|From Baseline (Week 0) to Weeks 12, 24, 52, and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.||Percent change||Standard Deviation|Mean
808562|NCT01034137|Secondary|Mean Percent Change From Baseline in the Swollen Joint Count (SJC) at Weeks 12, 24, 52, and 104|The number of swollen joints among 22 anatomical joints for both the right and left side of the body were assessed by a joint evaluator where the presence of a swollen joint was scored as 1 and absence as 0. The total SJC was derived by the sum of the scores for a range of SJC from 0 (best possible score; no swollen joints) to 44 (worse possible score; all joints swollen).|From Baseline (Week 0) to Weeks 12, 24, 52, and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.||Percent change||Standard Deviation|Mean
808563|NCT01034137|Secondary|Percentage of Participants With American College of Rheumatology 90 Response Rate at Weeks 12, 24, 52 and 104|ACR90 response is defined as a >=90% improvement (reduction) compared with baseline for both tender joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient’s Assessment of Pain over the previous 24 hours: using a VAS with left end of the line 0=no pain to right end of the line 100=unbearable pain; patient’s global assessment of disease activity and physician’s global assessment of disease activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; health assessment questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or erythrocyte sedimentation rate.|Weeks 12, 24, 52 and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement.||Percentage of participants|||Number
808564|NCT01034137|Secondary|Percentage of Participants With American College of Rheumatology 70 Response Rate at Weeks 12, 24, 52 and 104|ACR70 response is defined as a >=70% improvement (reduction) compared with baseline for both TJC68 and SJC66, as well as for three of the additional five ACR core set variables: patient’s Assessment of pain over the previous 24 hours: using a VAS with left end of the line 0=no pain to right end of the line 100=unbearable pain; patient’s global assessment of disease activity and physician’s global assessment of disease activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; health assessment questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.|Weeks 12, 24, 52 and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement.||Percentage of participants|||Number
808565|NCT01034137|Secondary|Percentage of Participants With American College of Rheumatology 50 Response Rate at Weeks 12, 24, 52 and 104|ACR50 response is defined as a >=50% improvement (reduction) compared with baseline for both TJC68 and SJC66, as well as for three of the additional five ACR core set variables: patient’s assessment of pain over the previous 24 hours: using a VAS with left end of the line 0=no pain to right end of the line 100=unbearable pain; patient’s Global assessment of disease activity and physician’s global assessment of disease activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.|Weeks 12, 24, 52 and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement.||Percentage of participants|||Number
808566|NCT01034137|Secondary|Percentage of Participants With American College of Rheumatology 20 Response Rate at Weeks 12, 24, 52 and 104|American College of Rheumatology (ACR) 20 response is defined as a >= 20% improvement (reduction) compared with baseline for both tender joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: patient’s assessment of pain over the previous 24 hours: using a Visual Analog Scale (VAS) with left end of the line 0=no pain to right end of the line 100=unbearable pain; patient’s global assessment of disease activity and physician’s global assessment of disease activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.|Weeks 12, 24, 52 and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement.||Percentage of participants|||Number
808597|NCT01034397|Secondary|Change From Baseline to Week 12 in Serum Cortisol|Change in serum cortisol was determined as the difference in the scores at Baseline and Week 12.|Week 12|ITT population||mg/dL||Full Range|Median
808598|NCT01034397|Secondary|Change From Baseline to Week 24 in CRP|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Week 24|ITT population||mg/dL||Full Range|Median
808678|NCT01034657|Secondary|Overall Survival (OS) - Overall Period|OS was defined as the time from start of treatment to death from any cause.|48 weeks|All participants from the core phase were analyzed.||months||90% Confidence Interval|Median
808567|NCT01034137|Secondary|Median Time to First European League Against Rheumatism Response|It is the time to first EULAR response. EULAR response criteria classify each participant as a good, moderate or non-responder to treatment based on the degree of improvement from baseline and the level of disease activity at the endpoint. EULAR response is derived using the individual participant’s DAS28 as the measure of severity of disease.Good or moderate response is defined as follows: Good response : DAS28 at the time point ≤ 3.2 and improvement from baseline > 1.2. Moderate response : DAS28 at the time point > 3.2 and improvement from baseline > 1.2, or DAS28 at the time point ≤ 5.1 and improvement from baseline > 0.6 and ≤ 1.2. Response 1 is defined as yes (good) versus no (moderate or no response). Response 2 is defined as yes (good or moderate) versus no (no response).|Up to Week 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement.||Days||Inter-Quartile Range|Median
808568|NCT01034137|Secondary|Number of Participants With Good European League Against Rheumatism Response Rate at Weeks 24, 52, and 104|European league against rheumatism (EULAR) response criteria classify each participant as a good, moderate or non-responder to treatment based on the degree of improvement from baseline and the level of disease activity at the endpoint. EULAR response is derived using the individual participant’s DAS28 as the measure of severity of disease. Good or moderate response is defined as follows: Good response : DAS28 at the time point =<3.2 and improvement from baseline > 1.2. Moderate response : DAS28 at the time point > 3.2 and improvement from baseline > 1.2, or DAS28 at the time point ≤ 5.1 and improvement from baseline > 0.6 and =<1.2.|Weeks 24, 52, and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.||Number of participants|||Number
808569|NCT01034137|Secondary|Median Change From Baseline in Simplified Disease Activity Index Scores at Weeks 24, 52, and 104|The simplified disease activity index (SDAI ) are continuous measures of RA disease activity.The SDAI is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PhGA (assessed on 0-10 cm VAS), and C-Reactive Protein (CRP) (mg/dL). SDAI total score ranges from 0-86. SDAI <=3.3 indicates disease remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity.|From Baseline (Week 0) to Weeks 24, 52, and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement.||Scores on a scale||Full Range|Median
808570|NCT01034137|Secondary|Median Change From Baseline in Clinical Disease Activity Index Score at Weeks 24, 52, and 104|The clinical disease activity index (CDAI) are continuous measures of RA disease activity. The CDAI is the numerical sum of four outcome parameters: tender joint count (TJC), swollen joint count (SJC) based on a 28-joint assessment; and patient's global assessment (PtGA) and physician's global assessment (PhGA) assessed on 0-10 cm visual analog scale (VAS). CDAI total score ranges from 0 to 76. CDAI <= 2.8 indicates clinical remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high (or severe) disease activity.|From Baseline (Week 0) to Weeks 24, 52, and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement.||Scores on a scale||Full Range|Median
808571|NCT01034137|Secondary|Absolute Change From Baseline in Disease Activity Score 28 at Weeks 12, 24, 52, and 104|The DAS28 score is a measure of the participant’s disease activity. DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement. Participants with missing data at visits before early study termination or who stopped the study prematurely because of insufficient therapeutic response or safety reasons considered non-responders or who stopped the study for other reasons, response set to missing after early withdrawal.|From Baseline (Week 0) to Weeks 12, 24, 52, and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement.||Scores on a scale||Full Range|Median
808572|NCT01034137|Secondary|Mean Duration of First Disease Activity Score 28 Remission|It is the duration of the first period of DAS28 remission.|Up to Week 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement.||Weeks||Standard Deviation|Mean
808573|NCT01034137|Secondary|Percentage of Participants With Cumulative Remission Rate at Weeks 12, 24, 52, and 104|The DAS28 score is a measure of the subject's disease activity. DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement. Participants with missing data at visits before early study termination or who stopped the study prematurely because of insufficient therapeutic response or safety reasons considered non-responders or who stopped the study for other reasons, response set to missing after early withdrawal.|Weeks 12, 24, 52, and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.||Percentage of participants|||Number
808574|NCT01034137|Secondary|Median Time to First Disease Activity Score 28 Remission|It is the time to event analysis for the first DAS28 remission.|Up to Week 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement.||Days||95% Confidence Interval|Median
808599|NCT01034397|Secondary|Change From Baseline to Week 12 in C-Reactive Protein (CRP)|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. CRP was measured in milligrams per deciliter (mg/dL).|Week 12|ITT population. After Week 12, participants receiving placebo could have been switched to tocilizumab.||mg/dL||Full Range|Median
808600|NCT01034397|Secondary|Change From Baseline to Week 24 in ESR|ESR is an inflammatory marker and is used to assess disease activity in RA. A reduction in ESR indicates improvement.|Week 24|ITT population||mm/hr||Full Range|Median
808575|NCT01034137|Secondary|Number of Participants Achieving Disease Activity Score 28 Remission at Weeks 12, 24, 52, and 104|The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores indicate worsening. DAS28 <2.6 equals (=) remission. Participants with missing data at visits before early study termination or who stopped the study prematurely because of insufficient therapeutic response or safety reasons considered non-responders or who stopped the study for other reasons, response set to missing after early withdrawal.|Weeks 12, 24, 52, and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.||Number of participants|||Number
808576|NCT01034137|Secondary|Mean Duration of First Sustained Remission|It is the duration of the first period of sustained DAS28 remission. Participants who switch treatment strategy before reaching sustained remission considered failures.|Up to Week 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.||Weeks||Standard Deviation|Mean
808577|NCT01034137|Secondary|Median Time to First Sustained Remission|It is the time to event analysis for the first period of sustained remission. Sustained remission is defined as DAS28 <2.6 during ≥23 weeks and no more than 4 swollen joints (28 joint count) due to RA at Week 24 of remission, with the exception of up to 2 in-between DAS28 values which could be between 2.6 and 3.2. The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen and tender joint counts (range 0-28), acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores indicate worsening. DAS28 <2.6 equals (=) remission.|Up to Week 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement.||days||95% Confidence Interval|Median
808578|NCT01034137|Primary|Percentage of Participants Achieving Sustained Remission Rate At Week 104|Sustained remission rate (SRR) is defined as Disease Activity Score 28 (DAS28) <2.6 during ≥ 23 weeks and no more than 4 swollen joints (28 joint count) due to RA at Week 24 of remission, with the exception of up to 2 in-between DAS28 values which could be between 2.6 and 3.2. The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores indicate worsening. DAS28 <2.6 equals (=) remission.|Week 104|The intent to treat (ITT) population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsules and performed at least one post-baseline efficacy measurement.||Percentage of participants|||Number
808579|NCT01034163|Primary|Number of Participants With Adverse Events|Safety monitoring was conducted throughout the study.|23 months|Safety set: The safety set included randomized participants who received at least one dose of study treatment.||Participants|||Number
808580|NCT01034176|Secondary|Number of Patients With >50% Reduction in BK Virus Copies|Number of patients with >50% reduction in BK viral load at 6 months|Baseline and 6 months|number of patients with >50% reduction in BK viral load at 6 months||participants|||Number
808581|NCT01034176|Primary|Percent Change From Baseline in BK Virus Copies at 3 Months|Percent change in BK virus copies/mL from Baseline to 3 months|Baseline and 3 months|||Percent change of BK virus copies||Standard Deviation|Median
808582|NCT01034306|Secondary|ACR 20/50/70, ITT and Evaluable Population, Last Observation Carried Disease Activity Score (DAS28) Change From Baseline at Each Visit in the Efficacy Parameters||12 weeks||||||
808583|NCT01034306|Secondary|Safety: Adverse Event Reporting, Physical Examination, Vital Signs, Clinical Laboratory Testing||12 weeks||||||
808584|NCT01034306|Primary|American College of Rheumatology (ACR20)|Primary efficacy was assessed using ACR20 response at Week 12, with all-cause dropouts considered as non-responders, in the ITT population.|12 weeks|||participants|||Number
808585|NCT01034358|Primary|Twelve Month Antibody Response to the Human Papillomavirus (HPV) Vaccine (Geometric Mean Titers [GMT])|Anti-HPV levels were determined by an assay conducted by Merck & Co, Inc. and expressed as milliMerck units per milliliter (mMU/mL).|One year|||mMU/mL||95% Confidence Interval|Geometric Mean
808586|NCT01034397|Secondary|Change From Baseline to Week 24 in Neuropeptide Y|Change in Neuropeptide Y was determined as the difference in the scores at Baseline and Week 24.|Week 24|ITT population||mg/dL||Full Range|Median
808587|NCT01034397|Secondary|Change From Baseline to Week 12 in Neuropeptide Y|Change in Neuropeptide Y was determined as the difference in the scores at Baseline and Week 12.|Week 12|ITT population||mg/dL||Full Range|Median
808588|NCT01034397|Secondary|Change From Baseline to Week 24 in Serum DHEA|Change in DHEA was determined as the difference in the scores at Baseline and Week 24.|Week 24|ITT population||mg/dL||Full Range|Median
808589|NCT01034397|Secondary|Change From Baseline to Week 12 in Serum Dehydroepiandrosterone (DHEA)|Change in DHEA was determined as the difference in the scores at Baseline and Week 12.|Week 12|ITT population||mg/dL||Full Range|Median
808590|NCT01034397|Secondary|Change From Baseline to Week 24 in 17OHP|Change in 17OHP was determined as the difference in the scores at Baseline and Week 24.|Week 24|ITT population||mg/dL||Full Range|Median
808591|NCT01034397|Secondary|Change From Baseline to Week 24 in Serum Androstenedione|Change in serum androstenedione was determined as the difference in the scores at Baseline and Week 24.|Week 24|ITT population||mg/dL||Full Range|Median
808592|NCT01034397|Secondary|Change From Baseline to Week 12 in 17 Hydroxy Progesterone (17OHP)|Change in 17OHP was determined as the difference in the scores at Baseline and Week 12.|Week 12|ITT population||mg/dL||Full Range|Median
808602|NCT01034397|Secondary|Health Assessment Questionnaire - Disease Index (HAQ-DI) Scores|The HAQ-DI includes 20 questions concerning participant’s activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant’s everyday activities: 0=without difficulties; 1=with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3.|Baseline, Weeks 12 and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit. After Week 12, participants receiving placebo could have been switched to tocilizumab.||units on a scale||Full Range|Median
808603|NCT01034397|Secondary|Change From Baseline to Week 24 in Patient Global Assessment of Pain|Patient's Global Assessment of Pain was assessed using a 10-mm horizontal VAS (0 to 10 mm) where 0=pain absent and 10=intolerable pain. Participants responded by placing a mark on the line to indicate their current level of pain; the distance from the left edge to the mark was recorded. Change in Patient Global Assessment of Pain was determined as the difference in the scores at baseline and Week 24. A negative number indicated improvement.|Week 24|ITT population||mm||Full Range|Median
808604|NCT01034397|Secondary|Change From Baseline to Week 12 in Patient Global Assessment of Pain|Patient's Global Assessment of Pain was assessed using a 10-mm horizontal VAS (0 to 10 mm) where 0=pain absent and 10=intolerable pain. Participants responded by placing a mark on the line to indicate their current level of pain; the distance from the left edge to the mark was recorded. Change in Patient Global Assessment of Pain was determined as the difference in the scores at baseline and Week 12. A negative number indicated improvement.|Week 12|ITT population. After Week 12, participants receiving placebo could have been switched to tocilizumab.||mm||Full Range|Median
808605|NCT01034397|Secondary|Patient Global Assessment of Pain|Patient's Global Assessment of Pain was assessed using a 10-mm horizontal VAS (0 to 10 mm) where 0=pain absent and 10=intolerable pain. Participants responded by placing a mark on the line to indicate their current level of pain; the distance from the left edge to the mark was recorded.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specific parameter at a given visit. After Week 12, participants receiving placebo could have been switched to tocilizumab.||mm||Full Range|Median
808606|NCT01034397|Secondary|Change From Baseline to Week 24 in Patient Global Assessment of Disease Activity|General health was assessed using the Patient Global Assessment of Disease Activity, a 0 to 10 mm VAS, where 0 mm = very well and 10 mm = extremely bad. Participants were asked to answer the following question: “In general how would you rate your health over the last 2-3 weeks?”. Participants responded by marking the line and the distance from the left edge was recorded.|Week 24|ITT population||mm||Full Range|Median
808607|NCT01034397|Secondary|Change From Baseline to Week 12 in Patient Global Assessment of Disease Activity|General health was assessed using the Patient Global Assessment of Disease Activity, a 0 to 10 mm VAS, where 0 mm = very well and 10 mm = extremely bad. Participants were asked to answer the following question: “In general how would you rate your health over the last 2-3 weeks?”. Participants responded by marking the line and the distance from the left edge was recorded.|Week 12|ITT population||mm||Full Range|Median
808608|NCT01034397|Secondary|Change From Baseline to Week 24 in SJC|Change in SJC was determined as the difference in the number of swollen joints at baseline and the number at Week 24. A negative number indicated improvement.|Week 24|ITT population||swollen joints||Full Range|Median
808609|NCT01034397|Secondary|Change From Baseline to Week 12 in SJC|Change in SJC was determined as the difference in the number of swollen joints at baseline and the number at Week 12. A negative number indicated improvement.|Week 12|ITT population||swollen joints||Full Range|Median
808610|NCT01034397|Secondary|Change From Baseline to Week 24 in TJC|Change in TJC was determined as the difference in the number of tender joints at baseline and the number at Week 24. A negative number indicated improvement.|Week 24|ITT population||tender joints||Full Range|Median
808611|NCT01034397|Secondary|Change From Baseline to Week 12 in TJC|Change in TJC was determined as the difference in the number of tender joints at baseline and the number at Week 12. A negative number indicated improvement.|Week 12|ITT population||tender joints||Full Range|Median
808612|NCT01034397|Secondary|Tender and Swollen Joint Counts|TJC and SJC were determined using the 28 joint counts. Joints were classified as tender/not tender and swollen/not swollen and counted. The scores ranged from 0 to 28. Higher scores indicated higher disease activity.|Weeks 12 and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit. After Week 12, participants receiving placebo could have been switched to tocilizumab.||joints||Full Range|Median
808613|NCT01034397|Secondary|Change From Baseline to Week 24 in DAS28 Global Score|DAS28 was calculated from the number of swollen joints and tender joints (SJC and TJC) using the 28-joint count, the ESR (mm/hr) and global health assessment (participant rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. Change in DAS28 global score was determined as the difference in the scores at baseline and Week 24. A negative number indicated improvement.|Week 24|ITT population||units on a scale||Full Range|Median
808614|NCT01034397|Secondary|Change From Baseline to Week 12 in DAS28 Global Score|DAS28 was calculated from the number of swollen joints and tender joints (SJC and TJC) using the 28-joint count, the ESR (mm/hr) and global health assessment (participant rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. Change in DAS28 global score was determined as the difference in the scores at baseline and Week 12. A negative number indicated improvement.|Week 12|ITT population. After Week 12, participants receiving placebo could have been switched to tocilizumab.||units on a scale||Full Range|Median
808615|NCT01034397|Secondary|Disease Activity Score Based on 28-Joint Count (DAS28)|DAS28 was calculated from the number of swollen joints and tender joints (SJC and TJC) using the 28-joint count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and global health assessment (participant rated global assessment of disease activity using 10-mm visual analog scale [VAS]); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity.|Baseline, Weeks 12 and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit. After Week 12, participants receiving placebo could have been switched to tocilizumab.||units on a scale||Full Range|Median
808616|NCT01034397|Secondary|Absolute Change From Baseline to Week 24 in DCE-MRI EER Wrist Score|Contrast enhancement was quantified in terms of IRE and Nvox, which are extracted by examining individual signal intensity vs time curves derived from defined ROIs. A volume ROI was manually drawn around wrist and MCP 2-5 joints at each visit representative of size/volume of enhancement and underlying inflammation. ME=mean of ME and Nplateau+Nwashout (Nvoxels) are number of voxels that have a plateau and washout, used to assess volume of enhancing voxels within drawn ROIs. IRE=percentage increase of SI until l ME is reached calculated as maximum increase in post-contrast SI divided by baseline SI; IRE=increase in SI in %/s from time of onset of enhancement to ME. EER reflects the IRE parameter and the output is the mean from the wrist ROIs (range=between 0 and 1; 0=no change/enhancement, 1=maximum change/enhancement. Negative change from Baseline score=improvement.|Week 24|ITT population||units on a scale||Full Range|Median
808617|NCT01034397|Secondary|Percent Change From Baseline to Week 24 in DCE-MRI EER Wrist Score|Contrast enhancement was quantified in terms of IRE and Nvox, which are extracted by examining individual signal intensity vs time curves derived from defined ROIs. A volume ROI was manually drawn around wrist and MCP 2-5 joints at each visit representative of size/volume of enhancement and underlying inflammation. ME=mean of ME and Nplateau+Nwashout (Nvoxels) are number of voxels that have a plateau and washout, used to assess volume of enhancing voxels within drawn ROIs. IRE=percentage increase of SI until l ME is reached calculated as maximum increase in post-contrast SI divided by baseline SI; IRE=increase in SI in %/s from time of onset of enhancement to ME. EER reflects the IRE parameter and the output is the mean from the wrist ROIs (range=between 0 and 1; 0=no change/enhancement, 1=maximum change/enhancement. Negative change from Baseline score=improvement.|Week 24|ITT population||percent change||Full Range|Median
808618|NCT01034397|Secondary|Absolute Change From Baseline to Week 12 in DCE-MRI EER Wrist Score|Contrast enhancement was quantified in terms of IRE and Nvox, which are extracted by examining individual signal intensity vs time curves derived from defined ROIs. A volume ROI was manually drawn around wrist and MCP 2-5 joints at each visit representative of size/volume of enhancement and underlying inflammation. ME=mean of ME and Nplateau+Nwashout (Nvoxels) are number of voxels that have a plateau and washout, used to assess volume of enhancing voxels within drawn ROIs. IRE=percentage increase of SI until l ME is reached calculated as maximum increase in post-contrast SI divided by baseline SI; IRE=increase in SI in %/s from time of onset of enhancement to ME. EER reflects the IRE parameter and the output is the mean from the wrist ROIs (range=between 0 and 1; 0=no change/enhancement, 1=maximum change/enhancement. Negative change from Baseline score=improvement.|Week 12|ITT population. After Week 12, participants receiving placebo could have been switched to tocilizumab.||units on a scale||Full Range|Median
808619|NCT01034397|Secondary|Percent Change From Baseline to Week 12 in DCE-MRI EER Wrist Score|Contrast enhancement was quantified in terms of IRE and Nvox, which are extracted by examining individual signal intensity vs time curves derived from defined ROIs. A volume ROI was manually drawn around wrist and MCP 2-5 joints at each visit representative of size/volume of enhancement and underlying inflammation. ME=mean of ME and Nplateau+Nwashout (Nvoxels) are number of voxels that have a plateau and washout, used to assess volume of enhancing voxels within drawn ROIs. IRE=percentage increase of SI until l ME is reached calculated as maximum increase in post-contrast SI divided by baseline SI; IRE=increase in SI in %/s from time of onset of enhancement to ME. EER reflects the IRE parameter and the output is the mean from the wrist ROIs (range=between 0 and 1; 0=no change/enhancement, 1=maximum change/enhancement. Negative change from Baseline score=improvement.|Week 12|ITT population. After Week 12, participants receiving placebo could have been switched to tocilizumab.||percent change||Full Range|Median
808620|NCT01034397|Secondary|Absolute Change From Baseline to Week 24 in DCE-MRI EER MCP Score|Contrast enhancement was quantified in terms of IRE and Nvox, which are extracted by examining individual signal intensity vs time curves derived from defined ROIs. A volume ROI was manually drawn around wrist and MCP 2-5 joints at each visit representative of size/volume of enhancement and underlying inflammation. ME=mean of ME and Nplateau+Nwashout (Nvoxels) are number of voxels that have a plateau and washout, used to assess volume of enhancing voxels within drawn ROIs. IRE=percentage increase of SI until l ME is reached calculated as maximum increase in post-contrast SI divided by baseline SI; IRE=increase in SI in %/s from time of onset of enhancement to ME. EER reflects the IRE parameter and the output is the mean from the MCP ROIs (range=between 0 and 1; 0=no change/enhancement, 1=maximum change/enhancement. Negative change from Baseline score=improvement.|Week 24|ITT population;||units on a scale||Full Range|Median
808621|NCT01034397|Secondary|Percent Change From Baseline to Week 24 in DCE-MRI EER MCP Score|Contrast enhancement was quantified in terms of IRE and Nvox, which are extracted by examining individual signal intensity vs time curves derived from defined ROIs. A volume ROI was manually drawn around wrist and MCP 2-5 joints at each visit representative of size/volume of enhancement and underlying inflammation. ME=mean of ME and Nplateau+Nwashout (Nvoxels) are number of voxels that have a plateau and washout, used to assess volume of enhancing voxels within drawn ROIs. IRE=percentage increase of SI until l ME is reached calculated as maximum increase in post-contrast SI divided by baseline SI; IRE=increase in SI in %/s from time of onset of enhancement to ME. EER reflects the IRE parameter and the output is the mean from the MCP ROIs (range=between 0 and 1; 0=no change/enhancement, 1=maximum change/enhancement. Negative change from Baseline score=improvement.|Week 24|ITT population;||percent change||Full Range|Median
808622|NCT01034397|Secondary|Absolute Change From Baseline to Week 12 in DCE-MRI EER MCP Score|Contrast enhancement was quantified in terms of IRE and Nvox, which are extracted by examining individual signal intensity vs time curves derived from defined ROIs. A volume ROI was manually drawn around wrist and MCP 2-5 joints at each visit representative of size/volume of enhancement and underlying inflammation. ME=mean of ME and Nplateau+Nwashout (Nvoxels) are number of voxels that have a plateau and washout, used to assess volume of enhancing voxels within drawn ROIs. IRE=percentage increase of SI until l ME is reached calculated as maximum increase in post-contrast SI divided by baseline SI; IRE=increase in SI in %/s from time of onset of enhancement to ME. EER reflects the IRE parameter and the output is the mean from the MCP ROIs (range=between 0 and 1; 0=no change/enhancement, 1=maximum change/enhancement. Negative change from Baseline score=improvement.|Week 12|ITT population. After Week 12, participants receiving placebo could have been switched to tocilizumab.||units on a scale||Full Range|Median
808842|NCT01038323|Primary|Change in Weekly Average Pain Intensity|Change in weekly average pain intensity score from baseline to week 21 (scale from -10 to +10; the more negative the value, the better in terms of pain reduction)|Baseline and Week 21clinic visits|||units on a scale||Standard Error|Mean
808623|NCT01034397|Secondary|Percent Change From Baseline to Week 12 in DCE-MRI EER MCP Score|Contrast enhancement was quantified in terms of IRE and Nvox, which are extracted by examining individual signal intensity vs time curves derived from defined ROIs. A volume ROI was manually drawn around wrist and MCP 2-5 joints at each visit representative of size/volume of enhancement and underlying inflammation. ME=mean of ME and Nplateau+Nwashout (Nvoxels) are number of voxels that have a plateau and washout, used to assess volume of enhancing voxels within drawn ROIs. IRE=percentage increase of SI until l ME is reached calculated as maximum increase in post-contrast SI divided by baseline SI; IRE=increase in SI in %/s from time of onset of enhancement to ME. EER reflects the IRE parameter and the output is the mean from the MCP ROIs (range=between 0 and 1; 0=no change/enhancement, 1=maximum change/enhancement. Negative change from Baseline score=improvement.|Week 12|ITT population. After Week 12, participants receiving placebo could have been switched to tocilizumab.||percent change||Full Range|Median
808624|NCT01034397|Secondary|Absolute Change From Baseline to Week 24 in DCE-MRI EER Global Score|Contrast enhancement was quantified in terms of IRE and Nvox, which are extracted by examining individual signal intensity vs time curves derived from defined ROIs. A volume ROI was manually drawn around wrist and MCP 2-5 joints at each visit representative of size/volume of enhancement and underlying inflammation. ME=mean of ME and Nplateau+Nwashout (Nvoxels) are number of voxels that have a plateau and washout, used to assess volume of enhancing voxels within drawn ROIs. IRE=percentage increase of SI until l ME is reached calculated as maximum increase in post-contrast SI divided by baseline SI; IRE=increase in SI in %/s from time of onset of enhancement to ME. EER reflects the IRE parameter and the output is the mean from all the assessed ROIs (range=between 0 and 1; 0=no change/enhancement, 1=maximum change/enhancement. Negative change from Baseline score=improvement.|Week 24|ITT population;||units on a scale||Full Range|Median
808625|NCT01034397|Secondary|Percent Change From Baseline to Week 24 in DCE-MRI EER Global Score|Contrast enhancement was quantified in terms of IRE and Nvox, which are extracted by examining individual signal intensity vs time curves derived from defined ROIs. A volume ROI was manually drawn around wrist and MCP 2-5 joints at each visit representative of size/volume of enhancement and underlying inflammation. ME=mean of ME and Nplateau+Nwashout (Nvoxels) are number of voxels that have a plateau and washout, used to assess volume of enhancing voxels within drawn ROIs. IRE=percentage increase of SI until l ME is reached calculated as maximum increase in post-contrast SI divided by baseline SI; IRE=increase in SI in %/s from time of onset of enhancement to ME. EER reflects the IRE parameter and the output is the mean from all the assessed ROIs (range=between 0 and 1; 0=no change/enhancement, 1=maximum change/enhancement. Negative change from Baseline score=improvement.|Week 24|ITT population||percent change||Full Range|Median
808626|NCT01034397|Secondary|Absolute Change From Baseline to Week 12 in Dynamic Contrast Enhanced (DCE)-MRI Early Enhancement Rate (EER) Global Score|Contrast enhancement was quantified in terms of IRE and Nvox, which are extracted by examining individual signal intensity vs time curves derived from defined ROIs. A volume ROI was manually drawn around wrist and MCP 2-5 joints at each visit representative of size/volume of enhancement and underlying inflammation. ME=mean of ME and Nplateau+Nwashout (Nvoxels) are number of voxels that have a plateau and washout, used to assess volume of enhancing voxels within drawn ROIs. IRE=percentage increase of SI until l ME is reached calculated as maximum increase in post-contrast SI divided by baseline SI; IRE=increase in SI in %/s from time of onset of enhancement to ME. EER reflects the IRE parameter and the output is the mean from all the assessed ROIs (range=between 0 and 1; 0=no change/enhancement, 1=maximum change/enhancement. Negative change from Baseline score=improvement.|Week 12|ITT population. After Week 12, participants receiving placebo could have been switched to tocilizumab.||units on a scale||Full Range|Median
808627|NCT01034397|Secondary|Percent Change From Baseline to Week 12 in Dynamic Contrast Enhanced (DCE)-MRI Early Enhancement Rate (EER) Global Score|Contrast enhancement was quantified in terms of initial rate of enhancement (IRE) and number of voxels (Nvox), which are extracted by examining individual signal intensity vs time curves derived from defined regions of interest (ROIs). A volume ROI was manually drawn around wrist and MCP 2-5 joints at each visit representative of size/volume of enhancement and underlying inflammation. Maximum enhancement (ME)=mean of ME and Nplateau+Nwashout (Nvoxels) are number of voxels that have a plateau and washout, used to assess volume of enhancing voxels within drawn ROIs. IRE=percentage increase of signal intensity (SI) until l ME is reached calculated as maximum increase in post-contrast SI divided by baseline SI; IRE=increase in SI in %/s from time of onset of enhancement to ME. EER reflects the IRE parameter and the output is the mean from all the assessed ROIs (range=between 0 and 1; 0=no change/enhancement, 1=maximum change/enhancement. Negative change from Baseline score=improvement.|Week 12|ITT population. After Week 12, participants receiving placebo could have been switched to tocilizumab.||percent change||Full Range|Median
808628|NCT01034397|Secondary|Absolute Change From Baseline to Week 24 in OMERACT RAMRIS Bone Edema Score|Bones from the wrist regions (carpal bones, distal radius, distal ulna and metacarpal bases) and the MCP joints (metacarpal heads and phalangeal bases) were assessed for edema via MRI and scored separately based on the proportion of bone with edema. Scoring ranged from 0 to 3 as follows: 0: no edema; 1: 1-33% of bone edematous; 2: 34-66% of bone edematous; 3: 67-100%. Summing these values yielded a scale from 0-45 for the wrist region, 0-24 for the MCP joints, and 0-69 on aggregate.|Week 24|ITT population; participants from the placebo group who did not show an improvement of ≥ 20% in TJC and SJC were offered recovery therapy with tocilizumab 8mg/kg and were placed in Placebo-Tocilizumab 8mg/kg group.||percent change||Full Range|Median
808629|NCT01034397|Secondary|Percent Change From Baseline to Week 24 in OMERACT RAMRIS Bone Edema Score|Bones from the wrist regions (carpal bones, distal radius, distal ulna and metacarpal bases) and the MCP joints (metacarpal heads and phalangeal bases) were assessed for edema via MRI and scored separately based on the proportion of bone with edema. Scoring ranged from 0 to 3 as follows: 0: no edema; 1: 1-33% of bone edematous; 2: 34-66% of bone edematous; 3: 67-100%. Summing these values yielded a scale from 0-45 for the wrist region, 0-24 for the MCP joints, and 0-69 on aggregate.|Week 24|ITT population; participants from the placebo group who did not show an improvement of ≥ 20% in TJC and SJC were offered recovery therapy with tocilizumab 8mg/kg and were placed in Placebo-Tocilizumab 8mg/kg group.||percent change||Full Range|Median
808768|NCT01035905|Primary|Lens Awareness|Lens awareness, as interpreted by the subject and reported by the subject in a questionnaire as a single, retrospective evaluation of 4-week’s wear time. Frequency of lens awareness was measured on a 4-point scale, with 1 being never and 4 being always. Four-week ratings were compared to baseline ratings, and a negative difference (4 week minus baseline) represented an improvement.|4 weeks of wear|Per Protocol||Participants|||Number
808630|NCT01034397|Secondary|Absolute Change From Baseline to Week 12 in OMERACT RAMRIS Bone Edema Score|Bones from the wrist regions (carpal bones, distal radius, distal ulna and metacarpal bases) and the MCP joints (metacarpal heads and phalangeal bases) were assessed for edema via MRI and scored separately based on the proportion of bone with edema. Scoring ranged from 0 to 3 as follows: 0: no edema; 1: 1-33% of bone edematous; 2: 34-66% of bone edematous; 3: 67-100%. Summing these values yielded a scale from 0-45 for the wrist region, 0-24 for the MCP joints, and 0-69 on aggregate.|Week 12|ITT population; n=number of participants assessed for the specified parameter at a given visit. After Week 12, participants receiving placebo could have been switched to tocilizumab.||units on a scale||Full Range|Median
808631|NCT01034397|Secondary|Percent Change From Baseline to Week 12 in OMERACT RAMRIS Bone Edema Score|Bones from the wrist regions (carpal bones, distal radius, distal ulna and metacarpal bases) and the MCP joints (metacarpal heads and phalangeal bases) were assessed for edema via MRI and scored separately based on the proportion of bone with edema. Scoring ranged from 0 to 3 as follows: 0: no edema; 1: 1-33% of bone edematous; 2: 34-66% of bone edematous; 3: 67-100%. Summing these values yielded a scale from 0-45 for the wrist region, 0-24 for the MCP joints, and 0-69 on aggregate.|Week 12|ITT population; n=number of participants assessed for the specified parameter at a given visit. After Week 12, participants receiving placebo could have been switched to tocilizumab.||percent change||Full Range|Median
808632|NCT01034397|Secondary|Absolute Change From Baseline to Week 24 in OMERACT RAMRIS Bone Erosion Score|Bones from the wrist regions (carpal bones, distal radius, distal ulna and metacarpal bases) and the MCP joints (metacarpal heads and phalangeal bases) were assessed for erosion via MRI and scored separately based on the proportion of eroded bone compared to the 'assessed bone volume' judged from all available images. Scoring ranges from 0 (no erosion) to 10 (91-100%). For long bones, the 'assessed bone volume' is from the articular surface to a depth of 1 cm (if the articular surface is absent its best estimated position is used), and in carpal bones it is the whole bone. Results were summed, resulting in scores from 0 to 80 for the wrist region, 0 to 150 for the MCP joints, and 0 to 230 on aggregate. A negative value in change from Baseline score indicates an improvement.|Week 24|ITT population; participants from the placebo group who did not show an improvement of ≥ 20% in TJC and SJC were offered recovery therapy with tocilizumab 8mg/kg and were placed in Placebo-Tocilizumab 8mg/kg group.||units on a scale||Full Range|Median
808633|NCT01034397|Secondary|Percent Change From Baseline to Week 24 in OMERACT RAMRIS Bone Erosion Score|Bones from the wrist regions (carpal bones, distal radius, distal ulna and metacarpal bases) and the MCP joints (metacarpal heads and phalangeal bases) were assessed for erosion via MRI and scored separately based on the proportion of eroded bone compared to the 'assessed bone volume' judged from all available images. Scoring ranges from 0 (no erosion) to 10 (91-100%). For long bones, the 'assessed bone volume' is from the articular surface to a depth of 1 cm (if the articular surface is absent its best estimated position is used), and in carpal bones it is the whole bone. Results were summed, resulting in scores from 0 to 80 for the wrist region, 0 to 150 for the MCP joints, and 0 to 230 on aggregate. A negative value in change from Baseline score indicates an improvement.|Week 24|ITT population||percent change||Full Range|Median
808634|NCT01034397|Secondary|Absolute Change From Baseline to Week 12 in OMERACT RAMRIS Bone Erosion Score|Bones from the wrist regions (carpal bones, distal radius, distal ulna and metacarpal bases) and the MCP joints (metacarpal heads and phalangeal bases) were assessed for erosion via MRI and scored separately based on the proportion of eroded bone compared to the 'assessed bone volume' judged from all available images. Scoring ranges from 0 (no erosion) to 10 (91-100%). For long bones, the 'assessed bone volume' is from the articular surface to a depth of 1 centimeter (cm) (if the articular surface is absent its best estimated position is used), and in carpal bones it is the whole bone. Results were summed, resulting in scores from 0 to 80 for the wrist region, 0 to 150 for the MCP joints, and 0 to 230 on aggregate. A negative value in change from Baseline score indicates an improvement.|Week 12|ITT population. After Week 12, participants receiving placebo could have been switched to tocilizumab.||units on a scale||Full Range|Median
808635|NCT01034397|Secondary|Percent Change From Baseline to Week 12 in OMERACT RAMRIS Bone Erosion Score|Bones from the wrist regions (carpal bones, distal radius, distal ulna and metacarpal bases) and the MCP joints (metacarpal heads and phalangeal bases) were assessed for erosion via MRI and scored separately based on the proportion of eroded bone compared to the 'assessed bone volume' judged from all available images. Scoring ranges from 0 (no erosion) to 10 (91-100%). For long bones, the 'assessed bone volume' is from the articular surface to a depth of 1 centimeter (cm) (if the articular surface is absent its best estimated position is used), and in carpal bones it is the whole bone. Results were summed, resulting in scores from 0 to 80 for the wrist region, 0 to 150 for the MCP joints, and 0 to 230 on aggregate. A negative value in change from Baseline score indicates an improvement.|Week 12|ITT population. After Week 12, participants receiving placebo could have been switched to tocilizumab.||percent change||Full Range|Median
808636|NCT01034397|Secondary|Absolute Change From Baseline to Week 24 in OMERACT-RAMRIS Synovitis Score|Synovitis is defined as an area in the synovial compartment that shows above normal postgadolinium enhancement of a thickness greater than the width of the normal synovium. T1-weighted images were acquired before and after the administration of intravenous contrast agent containing gadolinium. Intravenous contrast was required to demonstrate enhancing synovitis. Three wrist regions (distal radioulnar joint, radiocarpal joint, the intercarpal and intermetacarpal joint) and the 2nd to 5th MCP were assessed for synovitis via MRI and scored using a scale ranging from 0-3 where 0 is normal and scores 1-3 (mild, moderate, severe) are by thirds of the presumed volume of enhancing tissue in the synovial compartment. These values were then summed yielding scores of 0-9 in the wrist region, 0-12 for MCP joints, and 0-22 on the aggregate. A negative value in synovitis change from Baseline score indicates an improvement.|Week 24|ITT population.||units on a scale||Full Range|Median
808645|NCT01034540|Secondary|Difference Between Treatments in LMTT Insulin Secretion Index and Disposition Index.|"Insulin secretion index = total area under the curve from 0 to 120 min post-meal for plasma insulin divided by total area under the curve from 0 to 120 min post-meal for plasma glucose.
Disposition index = MISI x insulin secretion index"|End of Treatment Intervention Phase I (week 6) and End of Treatment Intervention Period II (week 14)|Per protocol population excluding subjects with poor compliance and protocol violations.||Index value||Standard Error|Mean
808769|NCT01035944|Secondary|Determine Cost Efficacy, Hemostasis and Patient Comfort Between Wounds Debrided at Bedside With HemCon Dressings & Wounds Debrided in Operating Room Setting.||2 days and 5 days after debridement.||||||
808637|NCT01034397|Secondary|Absolute Change From Baseline to Week 12 in OMERACT-RAMRIS Synovitis Score|Synovitis is defined as an area in the synovial compartment that shows above normal postgadolinium enhancement of a thickness greater than the width of the normal synovium. T1-weighted images were acquired before and after the administration of intravenous contrast agent containing gadolinium. Intravenous contrast was required to demonstrate enhancing synovitis. Three wrist regions (distal radioulnar joint, radiocarpal joint, the intercarpal and intermetacarpal joint) and the 2nd to 5th MCP were assessed for synovitis via MRI and scored using a scale ranging from 0-3 where 0 is normal and scores 1-3 (mild, moderate, severe) are by thirds of the presumed volume of enhancing tissue in the synovial compartment. These values were then summed yielding scores of 0-9 in the wrist region, 0-12 for MCP joints, and 0-22 on the aggregate. A negative value in synovitis change from Baseline score indicates an improvement.|Week 12|ITT population. After Week 12, participants receiving placebo could have been switched to tocilizumab.||units on a scale||Full Range|Median
808638|NCT01034397|Secondary|Absolute Change From Baseline to Week 24 in OMERACT RAMRIS Score|RAMRIS score is the sum of its core components: Synovitis Score, Edema Score, and Erosion Score. Synovitis scored from 0 (normal) to 9 (maximum distension of synovial cavity). Edema scored 0 (normal) to 69 (maximum articular bone involvement). Erosion scored from 0 (normal) to 230 (maximum erosion of articular bone). RAMRIS=Synovial Score + Edema Score + Erosion Score. Minimum RAMRIS score=0 (normal), maximum RAMRIS score=308 (severe structural damage). For Synovial Score, Edema Score, Erosion Score, and RAMRIS score, increasing number=increasing severity.|Week 24|ITT population; participants from the placebo group who did not show an improvement of ≥20% in TJC and SJC were offered recovery therapy with tocilizumab 8 mg/kg and were placed in Placebo-Tocilizumab 8 mg/kg group.||units on a scale||Full Range|Median
808639|NCT01034397|Secondary|Percent Change From Baseline to Week 24 in OMERACT RAMRIS Score|RAMRIS score is the sum of its core components: Synovitis Score, Edema Score, and Erosion Score. Synovitis scored from 0 (normal) to 9 (maximum distension of synovial cavity). Edema scored 0 (normal) to 69 (maximum articular bone involvement). Erosion scored from 0 (normal) to 230 (maximum erosion of articular bone). RAMRIS=Synovial Score + Edema Score + Erosion Score. Minimum RAMRIS score=0 (normal), maximum RAMRIS score=308 (severe structural damage). For Synovial Score, Edema Score, Erosion Score, and RAMRIS score, increasing number=increasing severity.|Week 24|ITT population; participants from the placebo group who did not show an improvement of ≥20% in TJC and SJC were offered recovery therapy with tocilizumab 8 mg/kg and were placed in Placebo-Tocilizumab 8 mg/kg group.||percent change||Full Range|Median
808640|NCT01034397|Secondary|Absolute Change From Baseline to Week 12 in OMERACT RAMRIS Score|RAMRIS score is the sum of its core components: Synovitis Score, Edema Score, and Erosion Score. Synovitis scored from 0 (normal) to 9 (maximum distension of synovial cavity). Edema scored 0 (normal) to 69 (maximum articular bone involvement). Erosion scored from 0 (normal) to 230 (maximum erosion of articular bone). RAMRIS=Synovial Score plus (+) Edema Score + Erosion Score. Minimum RAMRIS score=0 (normal), maximum RAMRIS score=308 (severe structural damage). For Synovial Score, Edema Score, Erosion Score, and RAMRIS score, increasing number=increasing severity.|Week 12|ITT population. After Week 12, participants receiving placebo could have been switched to tocilizumab.||units on a scale||Full Range|Median
808641|NCT01034397|Secondary|Percent Change From Baseline to Week 12 in OMERACT RAMRIS Score|RAMRIS score is the sum of its core components: Synovitis Score, Edema Score, and Erosion Score. Synovitis scored from 0 (normal) to 9 (maximum distension of synovial cavity). Edema scored 0 (normal) to 69 (maximum articular bone involvement). Erosion scored from 0 (normal) to 230 (maximum erosion of articular bone). RAMRIS=Synovial Score plus (+) Edema Score + Erosion Score. Minimum RAMRIS score=0 (normal), maximum RAMRIS score=308 (severe structural damage). For Synovial Score, Edema Score, Erosion Score, and RAMRIS score, increasing number=increasing severity.|Week 12|ITT population. After Week 12, participants receiving placebo could have been switched to tocilizumab.||percent change||Full Range|Median
808642|NCT01034397|Primary|Percent Change From Baseline to Week 12 in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score|Synovitis is defined as an area in the synovial compartment that shows above normal postgadolinium enhancement of a thickness greater than the width of the normal synovium. T1-weighted images were acquired before and after the administration of intravenous contrast agent containing gadolinium. Intravenous contrast was required to demonstrate enhancing synovitis. Three wrist regions (distal radioulnar joint, radiocarpal joint, the intercarpal and intermetacarpal joint) and the 2nd to 5th metacarpophalangeal (MCP) were assessed for synovitis via magnetic resonance imaging (MRI) and scored using a scale ranging from 0-3 where 0 is normal and scores 1-3 (mild, moderate, severe) are by thirds of the presumed volume of enhancing tissue in the synovial compartment. These values were then summed yielding scores of 0-9 in the wrist region, 0-12 for MCP joints, and 0-22 on the aggregate. A negative value in synovitis change from Baseline score indicates an improvement.|Week 12|ITT population; n (number) equals (=) number of participants assessed for the specified parameter||percent change||Full Range|Median
808643|NCT01034462|Secondary|Change in Sheehan Disability Scale (SDS) Total Score|The Sheehan Disability Scale (SDS) is a 3-item clinician-rated questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. All items are rated on an 11-point continuum (0 = no impairment to 10 = most severe) with the total SDS score ranging from 0 (no impairment) to 30 (most severe)|From Baseline to Week 8|"The Safety Population consisted of 434 randomized patients who took at least 1 dose of double-blind investigational product.
The Intent-to-Treat (ITT) Population consisted 429 patients in the Safety Population who had at least 1 postbaseline assessment of the MADRS total score."||units on a scale||Standard Error|Least Squares Mean
808644|NCT01034462|Primary|Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|"MADRS was used to assess depressive symptomatology during the past week. Patients are rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest.
Each item of the 10 items are scored on a 7-point scale. A score of 0 indicates the absence of symptoms,and a score of 6 indicates symptoms of maximum severity. The total MADRS score for this measure ranges from 0 (absence of symptoms) to 60 (maximum severity)."|From Baseline to Week 8|The Safety Population consisted of 434 randomized patients who took at least 1 dose of double-blind investigational product. The Intent-to-Treat (ITT) Population consisted 429 patients in the Safety Population who had at least 1 postbaseline assessment of the MADRS total score.||units on a scale||Standard Error|Least Squares Mean
808646|NCT01034540|Primary|Difference Between Treatments in Liquid Meal Tolerance Test (LMTT) Matsuda Insulin Sensitivity Index (MISI).|Liquid meal tolerance test (LMTT) = two 8 oz servings of Ensure (Abbott Nutrition) + study product followed by blood sample collection at -5, -1, 30, 60, 90, 120, 180, and 240 min, where t = 0 was start of liquid meal consumption. MISI calculated as 10,000/square root of (pre-meal glucose x pre-meal insulin x mean 120 min post-meal glucose x mean 120 min post-meal insulin)|End of Treatment Intervention Phase I (week 6) and End of Treatment Intervention Period II (week 14)|Per protocol population in which subjects with poor compliance, protocol violations, and without at least one post-randomization outcome data point during each treatment intervention period were removed.||Index value||Inter-Quartile Range|Median
808647|NCT01034553|Secondary|Overall Survival||Every 28 day cycle(up to 10 cycles) then follow-up for up to 2 years|All patients that received treatment were evaluated.||Months||95% Confidence Interval|Median
808648|NCT01034553|Secondary|Progression-free Survival||Every 28 day cycle(up to 10 cycles) then follow-up for up to 2 years|All patients that received treatment were evaluated.||Months||95% Confidence Interval|Median
808649|NCT01034553|Primary|Overall Response Rate to the Combination of MLN8237 and Bortezomib in Patients With Relapsed or Refractory Multiple Myeloma.|sCR: Normal serum FLC ratio, and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence, negative immunofixation of the serum and urine, <5% plasma cells in bone marrow, disappearance of any soft tissue plasmacytomas, and normalization of FLC ratio. VGPR:PR and serum and urine M-component detectable by immunofixation but not on electrophoresis, or if serum measurable,≥90% or greater reduction in serum M-component plus urine M-component <100 mg per 24h and if only measurable non-bone marrow parameter was FLC,≥90% or greater reduction in difference from involved and uninvolved FLC levels. PR:≥50% reduction of serum M-protein or reduction in 24-h urinary M-protein by ≥90% or to <200 mg per 24h or if FLC, ≥50% decrease in the difference between involved and uninvolved FLC levels or ≥50% reduction in bone marrow plasma cells is required in place of M-protein, provided baseline percentage was ≥30%, and ≥50% reduction in the size of soft tissue plasmacytomas|Every 28 day cycle(up to 10 cycles)|All patients that received treatment were evaluated.||percentage of patients per dose level|||Number
808650|NCT01034553|Primary|Dose-limiting Toxicity (DLT) (Phase I)|"Patients were evaluated over the first cycle of treatment for Dose Limiting Toxicities. For this trail DLTs are as follows:
An AE attributed (definitely, probably, or possibly) to study treatment during cycle 1 and the following criteria:
Grade 4 Neutropenia Grade 4 Thrombocytopenia, or grade 3 with bleeding Febrile neutropenia Creatinine serum great than 2 times baseline or upper limit of normal Grade 3 or higher Fatigue Grade 3 or higher nausea, vomiting, or diarrhea Any grade 3 or higher Non-hematologic toxicity per NCI CTCAE V4.0 Inability to initiate the scheduled cycle 2, day 1 due to toxicity
The maximum tolerated dose level (MTD) will be defined as the highest safely tolerated dose."|28 days|||participants|||Number
808651|NCT01034579|Secondary|Mean Number of Time Constant 2 (T2) Active Lesions Per Subject Per Scan as Defined by SNP5 Marker|Mean number of T2 active lesions was measured by using MRI scans. SNP5 is a three-level allele-based association SNP markers. The analysis was based on the number of copies of the allele (0, 1 and 2). Mean number of T2 active lesions segregated on the basis of SNP5 marker variables were reported.|Day 1 of EMR200136_023 study|MRI evaluable population was defined to include all participants from the evaluable population who had at least one post-baseline MRI evaluation during study 24735. Here, 'N' signifies number of participants who were evaluable for this outcome measure and 'n' signifies number of participants who were evaluable for the specified SNP categories.||T2 lesions||Standard Deviation|Mean
808652|NCT01034579|Secondary|Change in Brain Volume as Defined by SNP2 Marker|Change in brain volume was measured as the brain parenchymal fraction using MRI scans. SNP2 is two-level genotype-based SNP marker. The absence or presence of the genotype was analyzed as the dichotomous variable as 0 (absence of the genotype) and 1 (presence of the genotype). Change in brain volume segregated on the basis of SNP2 marker variables were reported.|Baseline (Day 1 of 24735 [NCT00078338] study) and Day 1 of EMR200136_023 study|MRI evaluable population was defined to include all participants from the evaluable population who had at least one post-baseline MRI evaluation during study 24735. Here, 'N' signifies number of participants who were evaluable for this outcome measure and 'n' signifies number of participants who were evaluable for the specified SNP categories.||cubic millimeter (mm^3)||Standard Deviation|Mean
808653|NCT01034579|Secondary|Change in Time Constant 1 Gadolinium (T1 Gd) Enhancing Lesion Volume as Defined by SNP3 and SNP4 Markers|Change in T1 Gd enhancing lesion volume was measured by using magnetic resonance imaging (MRI) scans. SNP4 is two-level genotype-based SNP marker. The absence or presence of the genotype was analyzed as the dichotomous variable as 0 (absence of the genotype) and 1 (presence of the genotype). SNP3 is a three-level allele-based association SNP markers. The analysis was based on the number of copies of the allele (0, 1 and 2). Change in T1 Gd enhancing lesion volume segregated on the basis of SNP3 and SNP4 marker variables were reported.|Baseline (Day 1 of 24735 [NCT00078338] study) and Day 1 of EMR200136_023 study|MRI evaluable population was defined to include all participants from the evaluable population who had at least one post-baseline MRI evaluation during study 24735. Here, 'N' signifies number of participants who were evaluable for this outcome measure and 'n' signifies number of participants who were evaluable for the specified SNP categories.||cubic millimeter (mm^3)||Standard Deviation|Mean
808654|NCT01034579|Secondary|Number of Participants With Confirmed Expanded Disability Status Scale (EDSS) Progression as Defined by SNP2 Marker|EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. EDSS progression was defined as increase by at least 1 point if last value of EDSS was equal to 5.5, and by at least 0.5 points if last EDSS was more than 5.5. SNP2 is two-level genotype-based SNP marker. The absence or presence of the genotype was analyzed as the dichotomous variable as 0 (absence of the genotype) and 1 (presence of the genotype). Number of responders segregated on the basis of SNP2 marker variable were reported.|Day 1 of EMR200136_023 study|Evaluable population. Here, 'N' signifies number of participants who were evaluable for this outcome measure and 'n' signifies number of participants who were evaluable for the specified SNP categories.||participants|||Number
808671|NCT01034631|Primary|Phase I: Toxicities of BNC105P in Combination With Everolimus.|Determine the toxicities of BNC105P in combination with everolimus. Drug-related treatment emergent adverse events by CTCAE grade 2 or greater are reported|Until disease progression or unacceptable toxicity, up to 24 cycles or 24 months|12 participants who completed at least one cycle of combination therapy.||participants|||Number
808655|NCT01034579|Primary|Percentage of Responders as Defined by Single Nucleotide Polymorphism (SNP) Markers|A responder was defined as a participant with no multiple sclerosis (MS) relapse and no Expanded Disability Status Scale (EDSS) progression during 96 weeks in 24735 (NCT00078338). All responders were categorized on the basis of following six SNP markers: SNP1, SNP2, SNP3, SNP4, SNP5, and SNP6. Two types of variables were possible for each SNP marker: two-level genotype-based or three-level allele-based association variables. For the two-level genotype-based SNP markers (SNP2, SNP4, and SNP6), the absence or presence of the genotype was analyzed as the dichotomous variable as 0 (absence of the genotype) and 1 (presence of the genotype). For the three-level allele-based association SNP markers (SNP1, SNP3, and SNP5), the analysis was based on the number of copies of the allele (0, 1 and 2). Percentage of responders segregated on the basis of SNP marker variable were reported.|Day 1 of EMR200136_023 study|Evaluable population. Here, 'N' signifies number of participants who were evaluable for this outcome measure and 'n' signifies number of participants who were evaluable for the specified SNP categories.||percentage of participants|||Number
808656|NCT01034592|Secondary|Toxicity|Toxicity was assessed as the number of adverse events related to lenalidomide.|6 months|Both participants were assessed and contributed to the analysis.||Related Adverse Events|||Number
808657|NCT01034592|Secondary|Duration of Response|The response duration was measured from the last of the consecutive 56 days during which the subject was free of red blood cells (RBC) transfusions to the date of the first RBC transfusion after the 56-day RBC-transfusion-free period.|6 months|Both participants were assessed and contributed to the analysis, but never demonstrated any therapeutic response.||days||Full Range|Median
808658|NCT01034592|Secondary|Platelet Response|The effect on platelet levels as assessed as the change in platelet count from baseline.|6 months|Both participants were assessed and contributed to the analysis.||1000/uL||Full Range|Median
808659|NCT01034592|Secondary|Neutrophil Response|The effect on neutrophil levels was assessed as the change in neutrophil count from baseline.|6 months|Both participants were assessed and contributed to the analysis.||1000/uL||Full Range|Median
808660|NCT01034592|Secondary|Hemoglobin Concentration|The effect on hemoglobin concentration was assessed as the change from baseline, measured in g/dL.|6 months|Both participants were assessed and contributed to the analysis.||g/dL||Full Range|Median
808661|NCT01034592|Secondary|Red Blood Cell (RBC) Transfusions|The effect on red blood cell (RBC) transfusions was assessed as the number of participants that achieved a greater than 50% decrease in RBC transfusion requirements.|6 months|Both participants were assessed and contributed to the analysis.||Participants|||Count of Participants
808662|NCT01034592|Primary|Red Blood Cell (RBC) Transfusion Independence|"Red blood cell (RBC) transfusion independence is reported as the number of subjects who achieve a continuous absence of the intravenous infusion of any RBC transfusion during any consecutive rolling 56 days during the treatment period."|6 months|All treated subjects were analyzed.||participants|||Number
808663|NCT01034631|Secondary|Exploratory Objective: Correlation of PFS With Biomarkers|Exploratory analysis of serum biomarkers were undertaken to generate a potential signature for response. The correlation with 6 month progression free survival P value for four plasma biomarkers is reported.|6 months|Analysis was pre-specified to look at the correlation irrespective of arm.||Correlation with PFS P Value|||Number
808664|NCT01034631|Secondary|Phase II: Overall Survival|Determine overall survival probability, up to a maximum of 5 years from registration for protocol therapy.|60 months|||probability of OS at 60 months.|||Number
808665|NCT01034631|Secondary|Phase II: Adverse Events of Everolimus and BNC105P When Administered as a Combination or Sequential Regimen.|Determine adverse events of everolimus and BNC105P when administered as a combination or sequential regimen. Total number of serious and non-serious adverse events for Arm A and Arm B are summarized. Complete adverse event information is supplied in the Adverse Events reporting section.|12 months|||number of adverse events|||Number
808666|NCT01034631|Secondary|Phase II: Progression Free Survival (PFS) With BNC105P Alone in Patients After Progressing on Everolimus.|Median time to progression for arm P participants who crossed over to BNC105P monotherapy after progression. Progression is defined per RECIST criteria as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions|12 months|||months||95% Confidence Interval|Median
808667|NCT01034631|Secondary|Phase II: Response Rate With Combination Therapy Compared to Everolimus Alone|Objective response is defined as a confirmed CR or PR per RECIST criteria. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|12 months|||Participants|||Count of Participants
808668|NCT01034631|Secondary|Geometric Mean Half-life of BNC105 and BNC105P in Combination With Everolimus.|Determine the PK Profile for BN105P in combination with everolimus by calculating the geometric mean half-life of BNC105P|12 months|14 participants has sufficient data collected for the analysis of this objective||hours||Full Range|Geometric Mean
808669|NCT01034631|Secondary|Phase I: Response Rate of BNC105P in Combination With Everolimus.|Number of objective responses per RECIST criteria. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Until disease progression or unacceptable toxicity, up to 24 cycles or 24 months|||Participants|||Count of Participants
808670|NCT01034631|Primary|Phase II: 6-month Progression Free Survival (PFS) With the Addition of BNC105P to Everolimus.|Improvement in 6-month PFS with the addition of BNC105P to everolimus. Progression is defined using RECIST criteria as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions|6 months|||probability of 6MPFS|||Number
808679|NCT01034657|Secondary|Mean Single Scoring Values of the IPSS - Randomized Phase|The IPSS score values were calculated based on the results of bone marrow analysis. A score value of 0 has bone marrow blast <5%, karyotype of normal, sole: -Y, del 5Q, del 20q and cytopenias (lineages affected) of 0 to 1. Score value of 0.5 has 5-10 bone marrow blasts, karyotype of Others and cytopenias of 2 to 3. A score value of 1.0 has complex >= 3 chromosomal abnormalities and/or chromosome 7 anomalies. A score of 1.5 has 11-20 bone marrow blasts and a score of 2.0 has 21-30 bone marrow blasts. The prognostic score is determined by the sum of the single scoring values. The risk groups are determined as follows: Low = 0 points (5.7 years of median survival); intermediate -1 (INT-1) = 0.5-1.0 points (3.5 years of median survival); INT-2 = 1.5-2.0 points (1.2 years of median survival); and high >=2.5 points (6 months of median survival).|52 weeks|Participants from the randomized phase, who had values at week 52, were included in the analysis.||units on a scale||Standard Deviation|Mean
808680|NCT01034657|Secondary|Mean Single Scoring Values of the IPSS - Core Phase|The IPSS score values were calculated based on the results of bone marrow analysis. A score value of 0 has bone marrow blast <5%, karyotype of normal, sole: -Y, del 5Q, del 20q and cytopenias (lineages affected) of 0 to 1. Score value of 0.5 has 5-10 bone marrow blasts, karyotype of Others and cytopenias of 2 to 3. A score value of 1.0 has complex >= 3 chromosomal abnormalities and/or chromosome 7 anomalies. A score of 1.5 has 11-20 bone marrow blasts and a score of 2.0 has 21-30 bone marrow blasts. The prognostic score is determined by the sum of the single scoring values. The risk groups are determined as follows: Low = 0 points (5.7 years of median survival); intermediate -1 (INT-1) = 0.5-1.0 points (3.5 years of median survival); INT-2 = 1.5-2.0 points (1.2 years of median survival); and high >=2.5 points (6 months of median survival).|baseline|All participants from the core phase were analyzed.||units on a scale||Standard Deviation|Mean
808681|NCT01034657|Secondary|Frequency Distribution of IPSS Score Status - Randomized Phase|The IPSS score values were calculated based on the results of bone marrow analysis. A score value of 0 has bone marrow blast <5%, karyotype of normal, sole: -Y, del 5Q, del 20q and cytopenias (lineages affected) of 0 to 1. Score value of 0.5 has 5-10 bone marrow blasts, karyotype of Others and cytopenias of 2 to 3. A score value of 1.0 has complex >= 3 chromosomal abnormalities and/or chromosome 7 anomalies. A score of 1.5 has 11-20 bone marrow blasts and a score of 2.0 has 21-30 bone marrow blasts. The prognostic score is determined by the sum of the single scoring values. The risk groups are determined as follows: Low = 0 points (5.7 years of median survival); intermediate -1 (INT-1) = 0.5-1.0 points (3.5 years of median survival); INT-2 = 1.5-2.0 points (1.2 years of median survival); and high >=2.5 points (6 months of median survival).|52 weeks|Only participants from the randomized phase, who had values at week 52, were included in the analysis.||Percentage of participants|||Number
808682|NCT01034657|Secondary|Frequency Distribution of IPSS Score Status - Core Phase|The IPSS score values were calculated based on the results of bone marrow analysis. A score value of 0 has bone marrow blast <5%, karyotype of normal, sole: -Y, del 5Q, del 20q and cytopenias (lineages affected) of 0 to 1. Score value of 0.5 has 5-10 bone marrow blasts, karyotype of Others and cytopenias of 2 to 3. A score value of 1.0 has complex >= 3 chromosomal abnormalities and/or chromosome 7 anomalies. A score of 1.5 has 11-20 bone marrow blasts and a score of 2.0 has 21-30 bone marrow blasts. The prognostic score is determined by the sum of the single scoring values. The risk groups are determined as follows: Low = 0 points (5.7 years of median survival); intermediate -1 (INT-1) = 0.5-1.0 points (3.5 years of median survival); INT-2 = 1.5-2.0 points (1.2 years of median survival); and high >=2.5 points (6 months of median survival).|baseline|All participants from the core phase were analyzed.||Percentage of participants|||Number
808683|NCT01034657|Secondary|Percentage of Participants With Objective Response During the Randomized Phase|Objective response (complete remission (CR) + partial remission (PR) and HI-platelet (HI-P) response + HI-neutrophil (HI-N) response) was assessed according to the modified IWG criteria: CR bone marrow with 5% myeloblasts with normal maturation of al cell lines (persistent dysplasia is noted) and peripheral blood with Hgb >= 11 g/dL platelets >=100 X 10^9/L, neutrophils >= 1.0 x 10^9/L and blasts 0%. PR = All CR if abnormal before treatment except bone marrow blasts decreased by>=50% over pretreatment but still >5% (ellularity and morphology not relevant). HI-P (pretreatment, < 100 x 109/L) = absolute increase of ≥ 30 x 109/L for participants starting with > 20 x 109/L and platelets Increase from < 20 x 109/L to > 20 x 109/L and by at least 100%; HI-N (pretreatment, < 1.0 x 109/L) = at least 100% increase and an absolute increase > 0.5 x 10^9/L.|32 weeks, 48 weeks|Participants from the randomized phase, who had valid data, were analyzed.||Percentage of participants|||Number
808684|NCT01034657|Secondary|Percentage of Participants With Objective Response During Core Phase|Objective response (complete remission (CR) + partial remission (PR) and HI-platelet (HI-P) response + HI-neutrophil (HI-N) response) was assessed according to the modified IWG criteria: CR bone marrow with 5% myeloblasts with normal maturation of al cell lines (persistent dysplasia is noted) and peripheral blood with Hgb >= 11 g/dL platelets >=100 X 10^9/L, neutrophils >= 1.0 x 10^9/L and blasts 0%. PR = All CR if abnormal before treatment except bone marrow blasts decreased by>=50% over pretreatment but still >5% (ellularity and morphology not relevant). HI-P (pretreatment, < 100 x 109/L) = absolute increase of ≥ 30 x 109/L for participants starting with > 20 x 109/L and platelets Increase from < 20 x 109/L to > 20 x 109/L and by at least 100%; HI-N (pretreatment, < 1.0 x 109/L) = at least 100% increase and an absolute increase > 0.5 x 10^9/L.|16 weeks|Participants from the core phase, who had valid data, were analyzed.||Percentage of participants|||Number
808685|NCT01034657|Secondary|Percentage of Participants With HI-E - Randomized Phase|HI-E was assessed according to the modified international working group (IWG) criteria for HI. Erythroid response (pretreatment, <11 g/dL): Hgb increase by ≥ 1.5 g/dL, relevant reduction of units of RBC transfusions by an absolute number of at least 4 RBC transfusions/8 wk compared with the pretreatment transfusion number in the previous 8 wk, and only RBC transfusions given for a Hgb of ≤ 9.0 g/dL pretreatment were counted in the RBC transfusion response evaluation; Platelet response (pretreatment, < 100 x 109/L): absolute increase of ≥ 30 x 109/L for participants starting with > 20 x 109/L and platelets Increase from < 20 x 109/L to > 20 x 109/L and by at least 100%; Neutrophil response (pretreatment, < 1.0 x 109/L): at least 100% increase and an absolute increase > 0.5 x 109/L; Progression or relapse after HI: At least 1 of the following: At least 50% decrement from maximum response levels in granulocytes or platelets, reduction in Hgb by ≥1.5 g/dL, or transfusion dependence.|32 weeks, 52 weeks|Participants from the randomized phase, who had valid response data, were analyzed.||Percentage of participants|||Number
808863|NCT01038713|Secondary|Determine the Days of Hospitalization Following Stent Placement|Number of total days of hospitalization for all patients in each group|From stent placement up to 500 days post stent|||Days|||Number
808686|NCT01034657|Primary|Percentage of Participants With Hematological Response of the Erythropoetic System (HI-E) - Core Phase|HI-E was assessed according to the modified international working group (IWG) criteria for HI. Erythroid response (pretreatment, <11 g/dL): Hgb increase by ≥ 1.5 g/dL, relevant reduction of units of RBC transfusions by an absolute number of at least 4 RBC transfusions/8 wk compared with the pretreatment transfusion number in the previous 8 wk, and only RBC transfusions given for a Hgb of ≤ 9.0 g/dL pretreatment were counted in the RBC transfusion response evaluation; Platelet response (pretreatment, < 100 x 109/L): absolute increase of ≥ 30 x 109/L for participants starting with > 20 x 109/L and platelets Increase from < 20 x 109/L to > 20 x 109/L and by at least 100%; Neutrophil response (pretreatment, < 1.0 x 109/L): at least 100% increase and an absolute increase > 0.5 x 109/L; Progression or relapse after HI: At least 1 of the following: At least 50% decrement from maximum response levels in granulocytes or platelets, reduction in Hgb by ≥1.5 g/dL, or transfusion dependence.|16 weeks|Participants from the core phase, who had valid response data, were analyzed.||Percentage of participants|||Number
808687|NCT01034709|Primary|a) CMV Viral Load|The CMV viral load was measured by both the artus CMV RG PCR test and the COBAS® AmpliPrep/COBAS® TaqMan® CMV Test at the investigational sites and then the percent agreement between the two tests was determined.|3 months|||percentage of agreement|||Number
808688|NCT01035047|Secondary|Stress Testing-related Adverse Event||Index Hospitalization through 90 days|Data from all participants was used for outcome analysis||participants|||Number
808689|NCT01035047|Secondary|Mortality||Index Hospitalization through 90 days|Data from all participants was used for outcome analysis.||participants|||Number
808690|NCT01035047|Secondary|Acute Coronary Syndrome||Index Hospitalization discharge through 90 days|Data from all participants was used in outcome analysis.||participants|||Number
808691|NCT01035047|Secondary|Length of Stay||Duration of Index Hospitalization, an average of 1-2 days|Data from all participants was used in outcome analysis.||hours||Full Range|Median
808692|NCT01035047|Primary|The Composite of Revascularization, Re-hospitalization, and Recurrent Cardiac Testing Through 90 Days.||Index Hospitalization through 90 days|Data from all participants was used in the primary outcome analysis.||participants|||Number
808693|NCT01035060|Primary|Muscle Satellite Cells|Change in the number of myonuclear cells identified as Pax7+ following contraction-induced skeletal muscle injury. Cells identified as Pax7+ by immunohistochemistry of skeletal muscle biopsy samples. Data adjusted for gender, physical activity level, and baseline satellite cell number.|Baseline, 2 days post-injury, 7 days post-injury|||Number of Pax7+ cells/muscle fiber||Standard Error|Mean
808694|NCT01035138|Secondary|Change From Baseline in Resource Utilization in Dementia-Lite Questionnaire (RUD-Lite) at Week 12|RUD-Lite assesses the healthcare resource utilization of participants and their caregivers to determine the level of formal and informal care attributable to Alzheimer's Disease (AD). Information on both caregivers (caregiving time, work status) and participants (accommodation and healthcare resource utilization) is collected from the baseline and follow-up interviews. Reported the change in number of hospitalizations per participant to week 12.|Baseline (LFAN Randomization), 12 weeks (LFBF)|Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.||number of hospitalizations||Standard Deviation|Mean
808695|NCT01035138|Secondary|Change From Baseline in EuroQol-5D (EQ-5D) at Week 24|EQ-5D (proxy version) measures mobility, self-care, usual activities, pain/discomfort, anxiety/depression; each has 3 severity levels (no, some, severe problems) coded to a 1-digit number (1-3). Digits are combined into 5-digit number describing health state. Numbers 1-3 are not added for total score. Visual Analog Scale (VAS) assesses caregiver's impression of participant's overall health state; VAS scores range=0-100, with lower scores indicating greater disease severity. LS Mean value was controlled for baseline value, age, investigator, and concomitant standard of care (SOC) medication.|Baseline (LFAN Randomization), 24 weeks (LFBF)|Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.||units on a scale||Standard Error|Least Squares Mean
808696|NCT01035138|Secondary|Change From Baseline in Neuropsychiatric Inventory (NPI) at Week 24|The NPI is a tool for assessing psychopathology in patients with dementia and other neurologic disorders. Information is obtained from a caregiver familiar with the patient’s behavior. The score ranges from 12 to 144, with higher scores indicating greater disease severity. Least Square (LS) Mean value was controlled for the baseline value, age, investigator, concomitant standard of care medication.|Baseline (LFAN Randomization), 24 weeks (LFBF)|Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.||units on a scale||Standard Error|Least Squares Mean
808697|NCT01035138|Secondary|Change From Baseline in Mini-Mental State Examination (MMSE) at Week 24|The MMSE is a brief screening instrument used to assess cognitive function in elderly participants. It assesses orientation, memory, attention, and ability to name objects, follow verbal and written commands, write a sentence, and copy figures. The total score ranges from 0 to 30, with a lower score indicating greater disease severity. Least Square (LS) Mean value was controlled for baseline value, age, investigator, and concomitant standard of care (SOC) medication.|Baseline (LFAN Randomization), 24 weeks (LFBF)|Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.||units on a scale||Standard Error|Least Squares Mean
808698|NCT01035138|Secondary|Change From Baseline in Clinical Dementia Rating Scale (Sum of Boxes) (CDR-SB) at Week 24|The CDR-SB is a semi-structured interview of participants and their caregivers. The participant's cognitive status is rated in 6 domains of functioning, including memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. A severity score is assigned for each of the 6 domains with total score ranging from 0 to 18. Higher scores indicate greater disease severity. Least Square (LS) Mean value was controlled for baseline value, age, investigator, and concomitant standard of care (SOC) medication.|Baseline (LFAN Randomization), 24 weeks (LFBF)|Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.||units on a scale||Standard Error|Least Squares Mean
808770|NCT01035944|Primary|Demonstrate That Debridements Using HemCon Dressings at Bedside Can be Performed Safely Without Excessive Bleeding; Compare Levels of Bacterial Load Between Debrided Wounds Treated With HemCon Dressings vs. Wounds Treated With Gauze & Saline Dressings.||2 days and 5 days after debridement.|Zero participant data were analyzed. Study was terminated early; unable to reach enrollment milestones.|||||
808699|NCT01035138|Secondary|Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog14) at Week 16 After Cessation of Study Drug|The ADAS-Cog14 is the ADAS-Cog11 augmented with delayed free recall, digit cancellation, and maze completion measures. A score of 0 to 10 for delayed free recall and a conversion code of 0 to 5 for digit cancellation and maze completion provide total score ranges for this extended ADAS-Cog14 of 0 to 90. Higher scores indicate greater disease severity.|Baseline (LFAN Randomization), 16 weeks (LFBF) after cessation of study drug|Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.||units on a scale||Standard Deviation|Mean
808700|NCT01035138|Secondary|Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog12) at Week 16 After Cessation of Study Drug|ADAS-Cog12 is the ADAS-Cog11 augmented with the delayed free recall measure, resulting in a total score ranging from 0 to 80. Higher scores indicate greater disease severity.|Baseline (LFAN Randomization), 16 weeks (LFBF) after cessation of study drug|Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.||units on a scale||Standard Deviation|Mean
808701|NCT01035138|Secondary|Mean Concentration of LY450139||3 months (pre-dose, 2, 4, and 6 hours after dosing )(LFBF)|Participants who completed Study LFAN, took study drug in extension study and had pharmacokinetics measurements.||nanogram/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
808702|NCT01035138|Secondary|Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) at Week 12|The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. It measures both basic and instrumental activities of daily living. The total score ranges from 0 to 78, with lower scores indicating greater disease severity. Least Square (LS) Mean value was controlled for baseline value, age, investigator, and concomitant standard of care (SOC) medication.|Baseline (LFAN Randomization), 12 weeks (LFBF)|Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.||units on a scale||Standard Error|Least Squares Mean
808703|NCT01035138|Secondary|Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog14) at Week 12|The ADAS-Cog14 is the ADAS-Cog11 augmented with delayed free recall, digit cancellation, and maze completion measures. A score of 0 to 10 for delayed free recall and a conversion code of 0 to 5 for digit cancellation and maze completion provide total score ranges for this extended ADAS-Cog14 of 0 to 90. Higher scores indicate greater disease severity. Least Square (LS) Mean value was controlled for the baseline value, age, investigator, and concomitant standard of care (SOC) medication.|Baseline (LFAN Randomization), 12 weeks (LFBF)|Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.||units on a scale||Standard Error|Least Squares Mean
808704|NCT01035138|Secondary|Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog12) at Week 12|ADAS-Cog12 is the ADAS-Cog11 augmented with the delayed free recall measure, resulting in a total score ranging from 0 to 80. Higher scores indicate greater disease severity. Least Square (LS) Mean value was controlled for baseline value, age, investigator, and concomitant standard of care (SOC) medication.|Baseline (LFAN Randomization), 12 weeks (LFBF)|Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.||units on a scale||Standard Error|Least Squares Mean
808705|NCT01035138|Secondary|Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog11) at Week 12|The cognitive subscale of the ADAS (ADAS-Cog11) consists of 11 items assessing areas of function most typically impaired in Alzheimer's Disease (AD): orientation, verbal memory, language, and praxis. The scale ranges from 0 to 70, with higher scores indicating greater disease severity. Least Square (LS) Mean value was controlled for baseline value, age, investigator, and concomitant standard of care (SOC) medication.|Baseline (LFAN Randomization), 12 weeks (LFBF)|Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.||units on a scale||Standard Error|Least Squares Mean
808706|NCT01035138|Secondary|Change From Baseline in Amyloid Imaging Positron Emission Tomography (AV-45-PET) at Week 12|A radioactive tracer for PET that is a ligand for amyloid called [18F]-AV-45. This permits the visualization of amyloid in the brains of Alzheimer's participants. The outcome reported is the composite summary of the standard uptake value ratio for the cerebellar gray matter. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator. Due to insufficient sample size, this analysis was not done.|Baseline (LFAN Randomization), 12 weeks (LFBF)|Due to insufficient sample size, this analysis was not done.|||||
808707|NCT01035138|Secondary|Change From Baseline in Hippocampal Volume Using Volumetric Magnetic Resonance Imaging (vMRI) at Week 12|The vMRI assessment of right hippocampal and left hippocampal volume is reported. Least Square (LS) Mean value was controlled for baseline value, age, and investigator.|Baseline (LFAN Randomization), 12 weeks (LFBF)|Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.||cubic millimeter (mm³)||Standard Error|Least Squares Mean
808708|NCT01035138|Secondary|Percent Change From Baseline in Amyloid Beta (Aβ) 1-42 Plasma Concentration at Week 12|Concentration of amino acid peptide known as Aβ 1-42 in plasma. Least Square (LS) Mean value was controlled for baseline value, age, and investigator.|Baseline (LFAN Randomization ), 6 hours pose-dose at Week 12 (LFBF)|Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.||percentage of change||Standard Error|Least Squares Mean
808709|NCT01035138|Primary|Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) at Week 16 After Cessation of Study Drug|The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. It measures both basic and instrumental activities of daily living. The total score ranges from 0 to 78, with lower scores indicating greater disease severity.|Baseline (LFAN randomization), 16 weeks (LFBF) after cessation of study drug|Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.||units on a scale||Standard Deviation|Mean
808771|NCT01020019|Primary|21 Days of Consecutive Abstinence as Measured by the Time-line Followback.||reported daily for 12 weeks/ or study participation|||participants|||Number
808710|NCT01035138|Primary|Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog11) at Week 16 After Cessation of Study Drug|The cognitive subscale of the ADAS (ADAS-Cog11) consists of 11 items assessing areas of function most typically impaired in Alzheimer's Disease (AD): orientation, verbal memory, language, and praxis. The scale ranges from 0 to 70, with higher scores indicating greater disease severity.|Baseline (LFAN randomization), 16 weeks (LFBF) after cessation of study drug|Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.||units on a scale||Standard Deviation|Mean
808711|NCT01035229|Secondary|Pharmacokinetics Assessments - Cmax|Cmax is the maximum (peak) blood drug concentration after dose administration (ng/mL) calculated as the maximum of C1h and C2h. C1h was 1 hour post-dose blood concentration (ng/mL) and C2h was 2 hour post-dose blood concentration (ng/mL). C1h and C2h post-dose samples were collected from all patients in both arms at Visit 3. Steady-state for the C1h and C2h samples was defined as continuous administration of the same dose in the previous 4 days and the day on which the C1h and C2h samples were collected. Steady-state for the 5 mg every other day regimen was defined as the state when the 5 mg dose was taken 2 days and 4 days before sampling. PK samples were only drawn at visit 3, and only analyzed for patients receiving everolimus at steady state (if patients had received the dose the previous 4 days). In addition summary statistics were only done for each everolimus dose when 3 samples were available. Only valid C1h and C2h everolimus samples were included in the analysis.|Until all patients have disease progression or leave study due to intolerable adverse events- Estimate of 1 year for each patient.|Safety Set consists of all patients who received at least one dose of study treatment with a valid postbaseline assessment. All PK analyses were based on the Safety Set.||ng/mL||Standard Deviation|Mean
808712|NCT01035229|Secondary|Pharmacokinetics Assessments - Cmin|Cmin is the pre-dose blood concentration at steady-state (ng/mL). Pre-dose (Cmin) blood samples were collected from all patients in both arms at Visit 3. Steady-state for the Cmin sample was defined as continuous administration of the same dose in the last 4 days prior to the collection of the Cmin sample. Steady-state for the 5 mg every other day regimen was defined as the state when the 5 mg dose was taken 2 days and 4 days before sampling. PK samples were only drawn at visit 3, and only analyzed for patients receiving everolimus at steady state (if patients had received the dose the previous 4 days). In addition summary statistics were only done for each everolimus dose when 3 samples were available. Only valid pre-dose (Cmin) everolimus samples were included in the analysis.|Until all patients have disease progression or leave study due to intolerable adverse events - Estimate of 1 year for each patient.|Safety Set consisted of all patients who received at least one dose of study treatment with a valid postbaseline assessment. All PK analyses were based on the Safety Set.||ng/mL||Standard Deviation|Mean
808713|NCT01035229|Secondary|Time to Definitive Deterioration of EORTC QLQ-C30 Scores|The primary quality of life endpoint was the time to definitive 5% deterioration from baseline in the global health status/quality of life scale of the EORTC QLQ-C30 questionnaire. Definitive deterioration by at least 5% is defined as a decrease in score by at least 5% compared to baseline, with no later observed increase above this threshold. The EORTC quality of life questionnaire (QLQ) is an integrated system for assessing the healthrelated quality of life (QoL) of cancer patients participating in international clinical trials. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.|Until all patients have disease progression or leave study due to intolerable adverse events - Estimate of 1 year for each patient.|The Full Analysis Set (FAS) comprised all randomized patients.||Months||95% Confidence Interval|Median
808714|NCT01035229|Secondary|Time to Definitive Deterioration of ECOG Performance Score (PS) Score|Change in Eastern Cooperative Oncology Group (ECOG) were assessed by time to definitive performance status deterioration by at least one category on the ECOG scale. Deterioration was considered definitive if no improvement in the ECOG PS was observed at a subsequent measurement. ECOG PS: 0=Fully active, able to carry on all pre-disease performance without restriction, 1=Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2=Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours; 3=Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours; 4=Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair; 5=Dead|Until all patients have disease progression or leave study due to intolerable adverse events- Estimate of 1 year for each patient.|The Full Analysis Set (FAS) comprised all randomized patients.||Months||95% Confidence Interval|Median
808715|NCT01035229|Secondary|Percentage of Participants With Disease Control Rate (DCR)|DCR is defined as the proportion of participants with a best objective response (BOR) of complete response (CR) or partial response (PR) or stable disease (SD) according to RECIST. The BOR was the best response recorded from the start of the treatment until disease progression. CR is disappearance of all target lesions; PR is at least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters; SD is neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD. PD is at least a 20% increase in the sum of the longest diameter of all measured target lesions, taking as reference the smallest sum of longest diameter of all target lesions recorded at or after baseline.|Until all patients have disease progression or leave study due to intolerable adverse events- Estimate of 1 year for each patient|The Full Analysis Set (FAS) comprised all randomized patients.||Percentage of Participants|||Number
808716|NCT01035229|Secondary|Time to Tumor Progression (TTP)|TTP was defined as the time from the date of randomization to the date of the first documented radiologic confirmation of disease progression. Since the study did not meet the primary objective, TTP was not formally tested.|Until all patients have disease progression or leave study due to intolerable adverse events- Estimate of 1 year for each patient|The Full Analysis Set (FAS) comprised all randomized patients.||Months||95% Confidence Interval|Median
808717|NCT01035229|Primary|Overall Survival (OS)|OS was defined as the time from the date of randomization to the date of death from any cause. The comparison of OS between the 2 arms was done using a stratified log-rank test at one-sided 2.5% level of significance.|When 454 OS events were observed|The Full Analysis Set (FAS) comprised all randomized patients.||Months||95% Confidence Interval|Median
808718|NCT01035255|Secondary|Percentage of Participants With New Onset of Atrial Fibrillation (AF)|Percentage of participants with New Onset of Atrial Fibrillation The new onset atrial fibrillation (AF) analysis was based on a subset of FAS: i.e., for patients without a history of AF at baseline (patients with a history of AF were excluded from this analysis).|up to 51 months|The new onset atrial fibrillation (AF) analysis was based on a subset of FAS: i.e., for patients without a history of AF at baseline (patients with a history of AF were excluded from this analysis).||Percentage of participants|||Number
808719|NCT01035255|Secondary|Number of Patients With First Confirmed Renal Dysfunction|Number of patients with first confirmed renal dysfunction|up to 51 months|Full Analysis Set (FAS) included all randomized patients but the following two exclusions: 6 patients who did not qualify for randomization but were inadvertently randomized into the study and did not receive double-blind study medication; 37 patients because they were randomized at sites that were closed due to serious GCP violations||participants|||Number
808720|NCT01035255|Secondary|Change From Baseline to Month 8 for the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score|Change from baseline to Month 8 for the Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score. KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. KCCQ clinical summary score is a composite assessment of physical limitations and total symptom scores. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.|Baseline, Month 8|FAS included all randomized patients with two exclusions: 6 pts who did not qualify for randomization but were misrandomized into the study and did not receive study meds; 37 pts because they were randomized at sites that were closed due to serious GCP violations The analysis included all FAS patients with at least one KCCQ data up-to Month 8.||KCCQ Score||Standard Error|Least Squares Mean
808721|NCT01035255|Secondary|Number of Patients Reported With Adjudicated Primary Causes of Death|Number of patients reported with adjudicated primary causes of death. The data is on Randomization population up to March 31, 2014|up to 51 months|Randomized set (RAN): Consisted of all patients who received a randomization number, regardless of receiving trial medication.||participants|||Number
808722|NCT01035255|Secondary|Number of Patients - All-cause Mortality|Number of patients - All-cause mortality. All-cause mortality is common in Heart Failure HF patients this measures how many patients had this event. The data is on FAS population up to March 31, 2014|up to 51 months|Full Analysis Set (FAS) included all randomized patients but the following two exclusions: 6 patients who did not qualify for randomization but were inadvertently randomized into the study and did not receive double-blind study medication; 37 patients because they were randomized at sites that were closed due to serious GCP violations||participants|||Number
808723|NCT01035255|Primary|Number of Participants That Had First Occurrence of the Composite Endpoint, Which is Defined as Either Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization|Number of participants that had first occurrence of the composite endpoint, which is defined as either CV death or HF hospitalization due to HF.|up to 51 months|Full Analysis Set (FAS) included all randomized patients but the following two exclusions: 6 patients who did not qualify for randomization but were inadvertently randomized into the study and did not receive double-blind study medication; 37 patients because they were randomized at sites that were closed due to serious GCP violations||participants|||Number
808724|NCT01035333|Secondary|Patient Satisfaction||6 months|Patients who completed 6 months of the study.||participants|||Number
808725|NCT01035333|Primary|Weight Loss|Weight loss acheived during time on study up to 6 months.|6 months|All patients data who were entered were analyzed, 19 recruited, 15 at 3 months, 9 at 6 months.||percentage of weight||Standard Deviation|Mean
808726|NCT01035346|Secondary|Rating of Study Medication Relative to Usual Medication|Rating of study medication was performed at the 8-hours time point or immediately before taking rescue medication (if necessary). It was scored on a 5-point categorical scale where 0=poor, 1=fair, 2=good, 3=very good, and 4=excellent.|8 hours|ITT population included all randomized participants who received study medication and provided a baseline temperature assessment.||units on a scale||Standard Deviation|Mean
808727|NCT01035346|Secondary|Global Assessment of Study Medication as an Antipyretic|Global assessment of study medication was performed at the 8-hours time point or immediately before taking rescue medication (if necessary). It was scored on a 5-point categorical scale where 0=poor, 1=fair, 2=good, 3=very good, and 4=excellent.|8 hours|ITT population included all randomized participants who received study medication and provided a baseline temperature assessment.||units on a scale||Standard Deviation|Mean
808728|NCT01035346|Secondary|Cumulative Percentage of Participants With Treatment Failure|Percentage of participants who withdrew from the study due to lack of efficacy or received rescue medication.|0.25, 0.5, 1, 2, 4, 6, 8 hours|ITT population included all randomized participants who received study medication and provided a baseline temperature assessment.||percentage of participants|||Number
808729|NCT01035346|Secondary|Time to Treatment Failure|Median time of dropping out of the participants from the study due to lack of efficacy or use of rescue medication, whichever comes first.|0 to 8 hours|ITT population included all randomized participants who received study medication and provided a baseline temperature assessment.||hours||95% Confidence Interval|Median
808730|NCT01035346|Secondary|Change From Baseline in Temperature at Hours 0.25, 0.5, 1, 2, 4, 6 and 8|Change from baseline in temperature was calculated as baseline temperature minus post-baseline temperature at each time point, where positive value indicated improvement in body temperature.|Baseline, 0.25, 0.5, 1, 2, 4, 6, 8 hours|ITT population included all randomized participants who received study medication and provided a baseline temperature assessment.||Degrees Fahrenheit||Standard Deviation|Mean
808731|NCT01035346|Secondary|Time-weighted Sum of The Temperature Differences From Baseline Through Hour 4 and Hour 8 (STEMPD 0-4 and STEMPD 0-8)|STEMPD 0-4 and STEMPD 0-8 were defined as the time-weighted sum of temperature differences over 4 hours and 8 hours, weighted by the time elapsed between each 2 consecutive time points. Temperature difference was defined as baseline temperature minus post-baseline temperature at each time point, where positive value indicated improvement in body temperature.|0 to 4, 0 to 8 hours|ITT population included all randomized participants who received study medication and provided a baseline temperature assessment.||Degrees Fahrenheit||Standard Deviation|Mean
808864|NCT01038713|Secondary|Total Cost Associated With the Placement of Biliary Stents Including the Cost of the Device as Well as the Secondary Costs of Device Placement.||Costs measured up to 500 days|||United States Dollars|||Number
808732|NCT01035346|Primary|Time-weighted Sum of The Temperature Differences From Baseline Through Hour 6 (STEMPD 0-6)|STEMPD 0-6 was defined as time-weighted sum of temperature differences over 6 hours, weighted by the time elapsed between each 2 consecutive time points. Temperature difference was defined as baseline temperature minus post-baseline temperature at each time point, where positive value indicated improvement in body temperature.|0 to 6 hours|Intent-to-treat (ITT) population included all randomized participants who received study medication and provided a baseline temperature assessment.||Degrees Fahrenheit||Standard Deviation|Mean
808733|NCT01035658|Primary|Phase I - Dose Limiting Toxicites|As requested, this outcome measure reports the number of patients experiencing dose limiting toxicites (DLTs) in the Phase I portion of the study|18 months|||participants|||Number
808734|NCT01035658|Secondary|To Evaluate the Toxicity of the Combination of Pazopanib and Liposomal Doxorubicin||18 months|Per protocol, study did not proceed to phase II based on analyses from phase I. Therefore, Phase II outcomes (all outcomes other than determination of the MTD) were not evaluated and will not be posted.|||||
808735|NCT01035658|Secondary|To Determine the Efficacy of Pazopanib/Liposomal Doxorubicin (Response Rate, Progression-free Survival, Overall Survival) Separately in the Subsets of Patients With Platinum-sensitive and Platinum-refractory Ovarian Carcinoma||18 months||||||
808736|NCT01035658|Secondary|To Determine the Overall Survival of Patients With Relapsed/Refractory Ovarian Cancer Following Treatment With Pazopanib and Liposomal Doxorubicin.||18 months|Per protocol, study did not proceed to phase II based on analyses from phase I. Therefore, Phase II outcomes (all outcomes other than determination of the MTD) were not evaluated and will not be posted.|||||
808737|NCT01035658|Primary|Phase II: Progression Free Survival|Defined as from date of randomization until objective tumor progression or death.|18 months|Per protocol, study did not proceed to phase II based on analyses from phase I. Therefore, Phase II outcomes (all outcomes other than determination of the MTD) were not evaluated and will not be posted.|||||
808738|NCT01035658|Primary|Phase I: Maximum Tolerated Dose (MTD) of Pazopanib and Liposomal Doxorubicin|The MTD of the drug combination will be determined as the highest dose at which ≤1 of 6 subjects experiences a Grade 3 or Grade 4 DLT according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0.|18 months|||mg|||Number
808739|NCT01035749|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs: medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the entire study period (Day 0 to Day 364)|The analysis was performed on the Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
808740|NCT01035749|Secondary|Number of Subjects Reporting Any Unsolicited AEs|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as any symptom regardless of intensity or relationship to vaccination.|During the 21-day (Days 0-20) follow-up period after booster vaccination.|"The analysis was performed on the Total Vaccinated cohort included all vaccinated subjects.
Note: 1 subject moved out of the study area thereby withdrawing from the study."||Subjects|||Number
808741|NCT01035749|Secondary|Number of Subjects Reporting Any Unsolicited AEs|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as any symptom regardless of intensity or relationship to vaccination.|During the 42-day (Days 0-41) follow up period after first vaccination.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subjects|||Number
808742|NCT01035749|Secondary|Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges|Subjects were categorized according to their results at pre-vaccination (PRE), Day 21, Day 42, Day 182 and Day 189 which were within normal, above normal, below the normal ranges or unknown. The laboratory parameters assessed were Alanine aminotransferase (ALAT), Aspartate aminotransferase (ASAT), Total Bilirubin, Creatinine, Hematocrit, Hemoglobin, Platelets, Blood urea nitrogen (BUN) and White blood cells (WBCs).|At Days 0, 21, 42, 182 and 189|"The analysis was performed on the Total Vaccinated cohort included all vaccinated subjects.
Note: 1 subject moved out of the study area thereby withdrawing from the study at Days 182 and 189."||Subjects|||Number
808743|NCT01035749|Secondary|Number of Subjects Reporting Potential Immune-Mediated Diseases (pIMDs)|pIMDs were defined as a subset of AEs that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.|During the entire study period (Days 0-364) following first vaccination|The analysis was performed on the Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
808744|NCT01035749|Secondary|Number of Subjects Reporting Any Medically Attended Events (MAEs)|MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason.|During the entire study period (Days 0-364) following the first vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subjects|||Number
808745|NCT01035749|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs|Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering, sweating and fever (Fever = axillary temperature equal to or above 38.0 degrees Celsius (°C)). Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature equal to or above (≥) 39.0°C.|During the 7-day (Days 0-6) post-vaccination period following booster dose|"The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
Note: 1 subject moved out of the study area thereby withdrawing from the study."||Subjects|||Number
808772|NCT01025492|Primary|Apolipoprotein A-I Serum Concentration|Comparison of apolipoprotein A-I concentrations after 12 weeks of treatment with either Trilipix or placebo|12 weeks|The clinical trial collaborator/corporate sponsor prematurely terminated the study and did not provide unblinding information to the investigator or study team, therefore it is not known to which arm/group each of the participants enrolled. Additionally, the study outcome measure/endpoint (Apolipoprotein A-I serum concentration) was not analyzed.|||||
808746|NCT01035749|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs|Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering, sweating and fever (Fever = axillary temperature equal to or above 38.0 degrees Celsius (°C)). Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature equal to or above (≥) 39.0°C.|During the 7-day (Days 0-6) post-vaccination period following each dose|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subjects|||Number
808747|NCT01035749|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local AEs|Any was defined as occurrence of any local symptom regardless of their intensity grade.Grade 3 redness and swelling was > 100 millimeter (mm) and grade 3 pain was defined as pain that prevented normal activity|During the 7-day (Days 0-6) post-vaccination period following booster dose|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subjects|||Number
808748|NCT01035749|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)|Any was defined as occurrence of any local symptom regardless of their intensity grade.Grade 3 redness and swelling was > 100 millimeter (mm) and grade 3 pain was defined as pain that prevented normal activity.|During the 7-day (Days 0-6) post-vaccination period following each dose|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subjects|||Number
808749|NCT01035749|Secondary|GMFR for HI Antibodies Against Flu A/CAL/7/09 H1N1 Using Day 182 as Reference Activity|GMFR (also known as the seroconversion factor, SCF) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.|At Day 189|The analysis was performed on the ATP cohort for immunogenicity at Day189,which included all subjects for whom the injection site was known,who received the vaccine/placebo on Day0,21 & booster on Day182 as PP & for whom assay results for Abs against A/California-like HA antigen for bloodsample taken21,42,182&189D after the 1st dose were available||Fold increase||95% Confidence Interval|Geometric Mean
808750|NCT01035749|Secondary|GMFR for HI Antibodies Against Flu A/CAL/7/09 H1N1 Using Day 0 as Reference Activity|GMFR (also known as the seroconversion factor, SCF) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.|At Day 189|The analysis was performed on the ATP cohort for immunogenicity at Day189,which included all subjects for whom the injection site was known,who received the vaccine/placebo on Day0,21 & booster on Day182 as PP & for whom assay results for Abs against A/California-like HA antigen for bloodsample taken21,42,182&189D after the 1st dose were available||Fold increase||95% Confidence Interval|Geometric Mean
808751|NCT01035749|Secondary|GMFR for HI Antibodies Against Flu A/CAL/7/09 H1N1|GMFR (also known as the seroconversion factor, SCF) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.|At Day 182|The analysis was performed on the ATP cohort for immunogenicity at Day182,which included all evaluated subjects for whom the injection site was known,who received the vaccine/placebo on Day0 & 21 as PP & for whom assay results for Abs against A/California-like HA antigen for bloodsample taken21,42 & 182 days after the 1st vaccination were available||Fold increase||95% Confidence Interval|Geometric Mean
808752|NCT01035749|Secondary|Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 H1N1|GMFR (also known as the seroconversion factor, SCF) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.|At Day 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42,which included all evaluated subjects for whom the injection site was known, who received the vaccine/placebo on both Day 0 and 21 as PP & for whom assay results for antibodies (Abs) against A/California-like HA antigen for blood sample taken on Day 21 & 42 were available.||Fold increase||95% Confidence Interval|Geometric Mean
808753|NCT01035749|Secondary|Number of Subjects Seroprotected to HI Antibodies Against Flu A/CAL/7/09 H1N1|A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.|At Day 0, Day 182 and Day 189|The analysis was performed on the ATP cohort for immunogenicity at Day189,which included all subjects for whom the injection site was known,who received the vaccine/placebo on Day0,21 & booster on Day182 as PP & for whom assay results for Abs against A/California-like HA antigen for bloodsample taken21,42,182&189D after the 1st dose were available||Subjects|||Number
808754|NCT01035749|Secondary|Number of Subjects Seroprotected to HI Antibodies Against Flu A/CAL/7/09 H1N1|A seroprotected subject was defined as a subject with a serum HI titre greater than or equal to 1:40 that usually is accepted as indicating protection.|At Day 0 and Day 182|The analysis was performed on the ATP cohort for immunogenicity at Day182,which included all evaluated subjects for whom the injection site was known,who received the vaccine/placebo on Day0 & 21 as PP & for whom assay results for Abs against A/California-like HA antigen for bloodsample taken21,42 & 182 days after the 1st vaccination were available||Subjects|||Number
808755|NCT01035749|Secondary|The Number of Subjects Seroprotected for HI Antibodies Against Flu A/CAL/7/09 H1N1|A seroprotected subject was defined as a subject with a serum HI titre greater than or equal to 1:40 that usually is accepted as indicating protection.|At Day 0 and Day 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42,which included all evaluated subjects for whom the injection site was known, who received the vaccine/placebo on both Day 0 and 21 as PP & for whom assay results for antibodies (Abs) against A/California-like HA antigen for blood sample taken on Day 21 & 42 were available||Subjects|||Number
808756|NCT01035749|Secondary|Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain|A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. Day 182 was used as reference activity.|At Day 189|The analysis was performed on the ATP cohort for immunogenicity at Day189,which included all subjects for whom the injection site was known,who received the vaccine/placebo on Day0,21 & booster on Day182 as PP & for whom assay results for Abs against A/California-like HA antigen for bloodsample taken21,42,182&189D after the 1st dose were available||Subjects|||Number
808757|NCT01035749|Secondary|Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain|A seroconverted subject was defined as a subject who had either a pre-vaccination titre below 1:10 and a post-vaccination titre greater than or equal to 1:40 or a pre-vaccination titre greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titre. Day 0 was used as reference activity.|At Day 189|The analysis was performed on the ATP cohort for immunogenicity at Day189,which included all subjects for whom the injection site was known,who received the vaccine/placebo on Day0,21 & booster on Day182 as PP & for whom assay results for Abs against A/California-like HA antigen for bloodsample taken21,42,182&189D after the 1st dose were available||Subjects|||Number
808758|NCT01035749|Secondary|Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain|A seroconverted subject was defined as a subject who had either a pre-vaccination titre below 1:10 and a post-vaccination titre greater than or equal to 1:40 or a pre-vaccination titre greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titre.|At Day 182|The analysis was performed on the ATP cohort for immunogenicity at Day182,which included all evaluated subjects for whom the injection site was known,who received the vaccine/placebo on Day0 & 21 as PP & for whom assay results for Abs against A/California-like HA antigen for bloodsample taken21,42 & 182 days after the 1st vaccination were available||Subjects|||Number
808759|NCT01035749|Secondary|HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain|Antibody titers were expressed as GMTs.|At Day 0 and Day 21|The analysis was performed on the ATP cohort for immunogenicity at Day21,which included all evaluated subjects for whom the injection site was known,who received the vaccine on Day0 as per protocol (PP) & for whom assay results for antibodies against A/California-like HA antigen for bloodsample taken 21days after the 1st vaccination were available.||Titers||95% Confidence Interval|Mean
808760|NCT01035749|Secondary|Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain|A seroconverted subject was defined as a subject who had either a pre-vaccination titre below 1:10 and a post-vaccination titre greater than or equal to 1:40 or a pre-vaccination titre greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titre.|At Day 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42,which included all evaluated subjects for whom the injection site was known, who received the vaccine/placebo on both Day 0 and 21 as PP & for whom assay results for antibodies (Abs) against A/California-like HA antigen for blood sample taken on Day 21 & 42 were available||Subjects|||Number
808761|NCT01035749|Secondary|HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain|Antibody titres were expressed as Geometric mean titers (GMTs).|At Days 0, 182 and 189|The analysis was performed on the ATP cohort for immunogenicity at Day189,which included all subjects for whom the injection site was known,who received the vaccine/placebo on Day0,21 & booster on Day182 as PP & for whom assay results for Abs against A/California-like HA antigen for bloodsample taken21,42,182&189D after the 1st dose were available||Titers||95% Confidence Interval|Geometric Mean
808762|NCT01035749|Secondary|HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain|Antibody titres were expressed as GMTs.|At Day 0 and Day 182|The analysis was performed on the ATP cohort for immunogenicity at Day182,which included all evaluated subjects for whom the injection site was known,who received the vaccine/placebo on Day0 & 21 as PP & for whom assay results for Abs against A/California-like HA antigen for bloodsample taken21,42 & 182 days after the 1st vaccination were available||Titers||95% Confidence Interval|Geometric Mean
808763|NCT01035749|Secondary|HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain|Antibody titres were expressed as Geometric mean titers (GMTs).|At Day 0 and Day 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42,which included all evaluated subjects for whom the injection site was known, who received the vaccine/placebo on both Day 0 and 21 as PP & for whom assay results for antibodies (Abs) against A/California-like HA antigen for blood sample taken on Day 21 & 42 were available.||Titers||95% Confidence Interval|Geometric Mean
808764|NCT01035749|Primary|HI Antibody Seroconversion Factors Against Flu A/CAL/7/09 H1N1 Strain|Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0.|At Day 21|The analysis was performed on the ATP cohort for immunogenicity at Day 42,which included all evaluated subjects for whom the injection site was known, who received the vaccine/placebo on both Day 0 and 21 as PP & for whom assay results for antibodies (Abs) against A/California-like HA antigen for blood sample taken on Day 21 & 42 were available.||Fold increase||95% Confidence Interval|Geometric Mean
808765|NCT01035749|Primary|Number of Subjects Seroprotected for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain|A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.|At Day 0 and Day 21|The analysis was performed on the ATP cohort for immunogenicity at Day21,which included all evaluated subjects for whom the injection site was known,who received the vaccine on Day0 as per protocol (PP) & for whom assay results for antibodies against A/California-like HA antigen for bloodsample taken 21days after the 1st vaccination were available.||Subjects|||Number
808766|NCT01035749|Primary|Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain|Seroconversion defined as: - For initially seronegative subjects, antibody titre ≥ 1:40 after vaccination - For initially seropositive subjects, antibody titre after vaccination ≥ 4 fold the pre-vaccination antibody titre|At Day 21|The analysis was performed on the ATP cohort for immunogenicity at Day21,which included all evaluated subjects for whom the injection site was known,who received the vaccine on Day0 as per protocol (PP) & for whom assay results for antibodies against A/California-like HA antigen for bloodsample taken 21days after the 1st vaccination were available.||Subjects|||Number
808767|NCT01035788|Primary|Clinician-Administered PTSD Scale (CAPS)|The Clinician Administered PTSD Scale (CAPS; Blake et al., 1995) is a semi-structured interview that evaluates PTSD symptoms and diagnostic status according to the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (APA, 2000). The intensity and frequency of each symptom is separately on a 5 point Likert scale ranging from zero to four. The total CAPS symptom severity score ranges from 0-136, with higher scores indicating greater PTSD symptoms severity. For the purposes of this study, a score of 45 or greater confirmed a diagnosis of PTSD.|treatment end (approximately 10 weeks after session 1 of the interventions)|This analysis was intention to treat and included the 30 participants of the original 34 who completed the CAPS interview at treatment end.||units on a scale||95% Confidence Interval|Least Squares Mean
808840|NCT01038323|Secondary|Identification of Group Assignment|Subjects identifying group assignment correctly|week 21|Information not captured (unfortunately)||participants|||Number
808773|NCT01025635|Secondary|Percentage of Participants With Investigator’s Global Assessment (IGA) Based Patient Response at End of Treatment (LOCF)|The IGA is a static evaluation of the overall severity of papulopustular rosacea at a given time. It consists of 5 scores ranging from clear to severe papulopustular rosacea and allows rapid overall evaluation of disease severity: 1) Clear: virtually no rosacea, ie, no papules and/or pustules; no erythema; 2) Minimal: rare papules and/or pustules; residual to mild erythema; 3) Mild: few papules and/or pustules; mild erythema; 4) Moderate: pronounced number of papules and/or pustules; moderate erythema; 5) Severe: numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions; moderate to severe erythema. Subjects achieving a clear, minimal, or mild IGA at the end of treatment were considered as ‘responder’. Subjects with an IGA of moderate or severe at the end of treatment were considered as ‘non-responder’. Subjects who prematurely withdraw from study treatment because of lack of efficacy were coded as ‘non-responders’.|At End of treatment (up to 12 weeks) (LOCF)|||Percentage of participants|||Number
808774|NCT01025635|Secondary|Percent Change From Baseline in IL Count (Sum of Papules and Pustules) Per Participant at End of Treatment (LOCF)||At End of treatment (up to 12 weeks) (LOCF)|||Percentage of Inflammatory lesions||Standard Deviation|Mean
808775|NCT01025635|Primary|Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) Per Participant at End of Treatment (LOCF)||Baseline and End of treatment (up to 12 weeks) (LOCF)|||Inflammatory lesions||Standard Deviation|Mean
808776|NCT01025635|Primary|Percentage of Participants With Investigator’s Global Assessment (IGA) Based Therapeutic Success at End of Treatment (LOCF: Last Observation Carried Forward)|The IGA is a static evaluation of the overall severity of papulopustular rosacea at a given time. It consists of 5 scores ranging from clear to severe papulopustular rosacea and allows rapid overall evaluation of disease severity: 1) Clear: virtually no rosacea, ie, no papules and/or pustules; no erythema; 2) Minimal: rare papules and/or pustules; residual to mild erythema; 3) Mild: few papules and/or pustules; mild erythema; 4) Moderate: pronounced number of papules and/or pustules; moderate erythema; 5) Severe: numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions; moderate to severe erythema. Therapeutic success is defined as an IGA score of clear or minimal.|At End of treatment (up to 12 weeks) (LOCF)|||Percentage of participants|||Number
808777|NCT01025817|Secondary|Number of Participants With Incidence of Adverse Events, Serious Adverse Events, and Tacrolimus-associated Adverse Events|Incidence of adverse events, serious adverse events, and tacrolimus-associated adverse events by System Organ Class|12 Months|Safety Set (SS) consisted of all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment. The statement that a patient had no adverse events constitutes a safety assessment. Those who received at least 1 dose of drug but had no post-treatment safety data of any kind are excluded from SS||Participants|Participants||Number
808778|NCT01025817|Secondary|Number of Participants With Incidence of Proteinuria Events|Number of participants with Incidence of proteinuria events indicating chronic kidney disease|Baseline and 12 Months|Safety Set (SS) consisted of all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment. The statement that a patient had no adverse events constitutes a safety assessment. Those who received at least 1 dose of drug but had no post-treatment safety data of any kind are excluded from SS||Participants|Participants||Number
808779|NCT01025817|Secondary|Number of Participants With Incidence of New Onset of Diabetes Mellitus|Incidence of new onset diabetes mellitus defined as non-diabetic patients before transplantation, who are receiving glucose lowering treatment for more than 30 days post-transplant, or with a random plasma glucose ≥200 mg dL (11.1 mmol/L) with 2 fasting plasma glucose values ≥126 mg/dL (7 mmol/L)|12 Months|Safety Set (SS) consisted of all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment. The statement that a patient had no adverse events constitutes a safety assessment. Those who received at least 1 dose of drug but had no post-treatment safety data of any kind are excluded from SS.||Participants|Participants||Number
808780|NCT01025817|Secondary|Number of Participants With Incidence Rates of BKV Viremia, BKV Viruria, or BKV Nephropathy|Participants with Incidence of BKV (viremia, viruria, or nephropathy). BKV is Polyomavirus type BK.|12 Months|Safety Set (SS) consisted of all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment. The statement that a patient had no adverse events constitutes a safety assessment. Those who received at least 1 dose of drug but had no post-treatment safety data of any kind are excluded from SS||Participants|Participants||Number
808781|NCT01025817|Secondary|Number of Participants With Incidence of CMV (Viremia, Syndrome and Disease)|Participants with incidence of CMV (viremia, syndrome and disease). CMV is cytomegalovirus.|12 Months|Safety Set (SS) consisted of all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment. The statement that a patient had no adverse events constitutes a safety assessment. Those who received at least 1 dose of drug but had no post-treatment safety data of any kind are excluded from SS.||Participants|Participants||Number
808782|NCT01025817|Secondary|Estimated Glomerular Filtration Rate (eGFR)|Renal function was assessed by estimated Glomerular Filtration Rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) formula. MDRD formula: GFR [mL/min/1.73m˄2] = 186.3*(C˄-1.154)*(A˄-0.203)*G*R. DEFINITIONS: C = serum concentration of creatinine [mg/dL]; A = age [years]; G = 0.742 when gender is female, otherwise G = 1; R = 1.21 when race is black, otherwise R = 1|12 Months|Full Analysis Set (FAS) consisted of all patients randomized after transplantation||mL/min/1.73m˄2||Standard Deviation|Mean
808783|NCT01025817|Primary|Number of Participants With Incidence of Composite Efficacy Failure|Efficacy failure rate used the composite endpoint of: (1) treated biopsy-proven acute rejection (BPAR)*, (2) graft loss**, (3) participant death or(4) loss to follow-up. *A treated BPAR was defined as a biopsy graded IA, IB, IIA, IIB, or III and which was treated with anti-rejection therapy. **Graft loss is defined as when the allograft was presumed lost on the day the participant started dialysis and was not able to subsequently be removed from dialysis.|12 Months|Full Analysis Set (FAS) consisted of all participants randomized after transplantation||Participants|Participants||Number
808784|NCT01025830|Secondary|Maximum Plasma Concentration of Drug|Maximum concentration of drug in plasma that was attained post dosing|Assessed at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 10 and 12 hr post-dosing|Intention to treat analysis used including only participants with sufficient plasma samples for analysis. Separate analyses are given for each drug. Results for this kind of study are not combined.||milligram/liter||Standard Deviation|Geometric Mean
808785|NCT01025830|Primary|Area Under the Concentration-Time Curve(AUC)|Mean Area Under the Plasma Concentration-Time Curve for each drug, log transformed|Assessed at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 10 and 12 hr post-dosing|Analyzed population consists only of participants who had sufficient plasma samples for analysis.Intent to treat analysis was used. Separate analyses provided for each drug. Results of such a study are not combined.||hour*milligram/liter||Standard Deviation|Geometric Mean
808786|NCT01025843|Secondary|Maximum Plasma Concentration (Cmax) of MK-5478 and Candesartan|Blood was collected at the following time points: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, and 48 hours post-dose in order to measure the Cmax of MK-5478 and Candesartan|Pre-dose and up to 48 hours postdose|In order to keep the study blinded, the scheduled number of treated participants rather than the actual number of treated participants were analyzed; according to the scheduled study drug and not by randomly assigned sequence.||µmol/L||Standard Deviation|Mean
808787|NCT01025843|Secondary|Change From Baseline in Aortic Augmentation Index (AIx) of MK-5478 and Candesartan|Central blood pressure (CBP) parameters will be measured and used to derive the aortic augmentation index (AIx). The AIx quantifies the contribution of back-reflected outgoing systolic pressure waves to late-systolic central blood pressure, which increases with decreasing aortic compliance. AIx is measured by pulse wave analysis using the SphygmoCor System supplied by AtCor Medical. Results with a > 5% decrease in AIx were planned for analysis; results with a < 5% decrease in AIx were not analysed.|Baseline and 1 to 3 hours postdose|Results were not analyzed because none showed a > 5% decrease in AIx.|||||
808788|NCT01025843|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC 0-infinity) of MK-5478 and Candesartan|Blood was collected at the following time points: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, and 48 hours post-dose in order to measure AUC 0-infinity of MK-5478 and Candesartan|Pre-dose and up to 48 hours postdose|In order to keep the study blinded, the scheduled number of treated participants rather than the actual number of treated participants were analyzed; according to the scheduled study drug and not by randomly assigned sequence.||umol.hr/L||Standard Deviation|Mean
808789|NCT01025843|Primary|Number of Participants Who Discontinued Treatment Due to an AE|An AE is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR’s product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR’s product, is also an AE.|Up to 24 hours after administration of study drug|All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.||Participants|||Number
808790|NCT01025843|Primary|Number of Participants With One or More Adverse Events (AEs)|An AE is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR’s product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR’s product, is also an AE.|Up to 14 days after administration of last dose of study drug (up to Day 52)|All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.||Participants|||Number
808791|NCT01036009|Post-Hoc|Time Until Late Relapse|Number of months post-transplant until late relapse, in intervention patients relapsing after the 2-year primary study endpoint. Relapse defined as >5% blasts in bone marrow|24-36 months post-transplant|intervention patients who relapsed after the 2 year primary study endpoint||months||Full Range|Mean
808792|NCT01036009|Post-Hoc|Late Relapses|The number of patients who relapsed after 2-year primary endpoint. To assess a potential for late relapse-rate in the intervention arm only, patients in the intervention arm were provided additional follow-up until 3-yrs post transplant. The criterion for relapse was >5% blasts in bone marrow.|24-36 months post-transplant|surviving patients in the intervention arm who had not relapsed as of 24 months were followed for an additional 12 months (until 3 years post-transplant)||participants|||Number
808793|NCT01036009|Secondary|The Incidence of Chronic GVHD (cGVHD).|"Diagnostic criteria of cGVHD from: Filipovich AH, Weisdorf D, Pavletic S et al. National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-host disease: I Diagnosis and Staging Working Group Report. Biology of Blood and Marrow Transplantation 2005;11:945-955.
The diagnosis of chronic GVHD requires the following:
1) Distinction from acute GVHD; 2) Presence of at least 1 diagnostic clinical sign of chronic GVHD or presence of at least 1 distinctive manifestation confirmed by pertinent biopsy or other relevant tests; 3) Exclusion of other possible diagnoses.
Scoring of organ manifestations requires careful assessment of signs, symptoms, laboratory values, and other study results. A clinical scoring system (0-3) is used for evaluation of the involvement of individual organs and sites. Global assessment of severity (mild, moderate, or severe) is derived by combining organ- and site-specific scores."|2 years post transplant|||participants|||Number
808794|NCT01036009|Secondary|The Incidence of Acute Graft Versus Host Disease (aGVHD).|"Definition and diagnostic criteria of aGVHD according to: 1994 Consensus Conference on Acute GVHD Grading. Przepiorka D1, Weisdorf D, Martin P, Klingemann HG, Beatty P, Hows J, Thomas ED. Bone Marrow Transplant. 1995 Jun;15(6):825-8.
In this system, patients are divided into one of four grades (I-IV) depending on the degree, or stage, of involvement in three organs. The skin is staged with percent body surface involved, the liver is staged with degree of bilirubin elevation, and the gastrointestinal tract is staged with amount of diarrhea."|2 years post transplant|||participants|||Number
808795|NCT01036009|Secondary|2 Years Post-transplant Survival.||2 years post transplant|||participants|||Number
808796|NCT01036009|Primary|Relapse at 2 Years Post-transplant.|Definition of relapse was >5 % blasts in bone marrow|2 years post transplant.|||participants|||Number
808797|NCT01036022|Secondary|Volume of Distribution Estimated Based on Population Pharmacokinetic Analysis of Healthy Volunteers (Historical Data) and Patient Data|Volume of distribution derived from concentration-time data was planned to be combined with data from healthy volunteers from Phase I study to characterize the population pharmacokinetics of GSK1399686. However data for this outcome measure was not collected.|Day 1 (1 hour, 2 hour, 3 hour post dose), Week 1 (anytime relative to the last dose), Week 2 (anytime relative to the last dose) and Day 28 (Week 4 at pre dose, 1 hour, 2 hour, 3 hour and 4 hour morning post dose)|PK Population.|||||
808798|NCT01036022|Secondary|Plasma Clearance Estimated Based on Population Pharmacokinetic Analysis of Healthy Volunteers (Historical Data) and Patient Data|Clearance derived from plasma concentration-time data was planned to be combined with data from healthy volunteers from Phase I study to characterize the population pharmacokinetics of GSK1399686. However data for this outcome measure was not collected.|Day 1 (1 hour, 2 hour, 3 hour post dose), Week 1 (anytime relative to the last dose), Week 2 (anytime relative to the last dose) and Day 28 (Week 4 at pre dose, 1 hour, 2 hour, 3 hour and 4 hour morning post dose)|PK Population.|||||
808799|NCT01036022|Secondary|Pre-dose Trough Concentration at the End of the Dosing Interval (Cτ) on Day 28 Derived From Observed Plasma Concentrations of GSK1399686 After Repeated Oral Dosing|Cτ was derived on Day 28 from observed plasma concentrations of GSK1399686 after repeated oral dosing. Blood samples were collected on Day 28 (Week 4 at pre dose, 1 hour, 2 hour, 3 hour and 4 hour morning post dose).|Day 28 (Week 4 at pre dose, 1 hour, 2 hour, 3 hour and 4 hour morning post dose)|PK Population. Data is presented for the participants available at the time of assessment.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
808800|NCT01036022|Secondary|Mean Maximum Observed Concentration (Cmax) on Day 1 and Day 28 Derived From Observed Plasma Concentrations of GSK1399686 After Repeated Oral Dosing|Cmax was derived on Day 1 and Day 28 from observed plasma concentrations of GSK1399686 after repeated oral dosing. Blood samples were collected on Day 1 (1 hour, 2 hour, 3 hour post dose) and Day 28 (Week 4 at pre dose, 1 hour, 2 hour, 3 hour and 4 hour morning post dose).|Day 1 (1 hour, 2 hour, 3 hour post dose) and Day 28 (Week 4 at pre dose, 1 hour, 2 hour, 3 hour and 4 hour morning post dose)|PK Population. Only those participants available at the specified time points were analyzed.||Nanogram (ng)/mL||Geometric Coefficient of Variation|Geometric Mean
808801|NCT01036022|Secondary|Mean Fecal Lactoferrin Levels Over Time|Fecal lactoferrin, a non-invasive surrogate marker of inflammation in the small intestine, and levels of which was associated with mucosal healing. Lactoferrin is an iron binding glycoprotein that is the major component of the secondary granules of polymorphonuclear neutrophils (but not monocytes and lymphocytes). Lactoferrin is produced in significant amounts by inflammatory cells. Fecal levels of this protein has been demonstrated to correlate with colorectal and intestinal inflammation. Lactoferrin plays an important role in the innate immunity as a bactericidal and used as a diagnostic biomarker. It was assessed from Week 1 to Week 6.|Up to Week 6|ITT Population. Only those participants available at the specified time points were analyzed. Analysis was done on OC data referred to data collected on the eCRF without any imputations added.||µg/L||Geometric Coefficient of Variation|Geometric Mean
808802|NCT01036022|Secondary|Mean Fecal Calprotectin Levels Over Time|Fecal calprotectin, a non-invasive surrogate marker of inflammation in the small intestine, and levels of which was associated with mucosal healing. Calprotectin is a calcium and zinc-binding protein found in neutrophils, monocytes and macrophages. Calprotectin is produced in significant amounts by inflammatory cells. Fecal levels of this protein has been demonstrated to correlate with colorectal and intestinal inflammation. Calprotectin plays a regulatory role in the inflammatory process and used as a diagnostic biomarker. It was assessed from Week 1 to Week 6.|Up to Week 6|ITT Population. Only those participants available at the specified time points were analyzed. Analysis was done on OC data referred to data collected on the eCRF without any imputations added.||μg/g||Geometric Coefficient of Variation|Geometric Mean
808803|NCT01036022|Secondary|Median Time to Clinical Response and Clinical Remission|Time to clinical response was defined as the number of days between first dose of study medication and first day of at least 3 consecutive days with SCCAI score decreased for >2 points in comparison with baseline (Day -1 value). Time to clinical remission was defined as the number of days between the first dose of study medication and the first day of at least 3 consecutive days with SCCAI score < 3. Time to clinical response and remission was derived using daily diary data. Participants who did not meet the criteria for clinical response or clinical remission were censored at their last day on study medication.|Up to Week 6|ITT Population. Data is presented for the participants available at the time of assessment. Analysis was done on OC data referred to data collected on the eCRF without any imputations added.||Days||Full Range|Median
808804|NCT01036022|Secondary|Number of Participants With Clinical Response and Clinical Remission at Week 4 and Week 6|Participants were defined as clinical responders if the average change from baseline total SCCAI score was <-2. (i.e. the post dose total SCCAI score was decreased by >2 points compared to the baseline total SCCAI score). Baseline was defined as the value on Day -1. The change from baseline total SCCAI score was derived by subtracting the baseline value (Day -1) from the individual post-dose values. Participants were defined as in clinical remission if the post dose total SCCAI score was <3 and baseline SCCAI score was not <3 (i.e . =>3).|Week 4 and Week 6|ITT Population. Only those participants available at the specified time points were analyzed. Analysis was done on OC data referred to data collected on the eCRF without any imputations added.||Participants|||Number
808805|NCT01036022|Secondary|Mean Simple Clinical Colitis Activity Index (SCCAI) Score|SSCAI included composite score: bowel frequency during day on a scale of 0-3 defined as 0 was <= 3, 1= 4 to 6, 2= 7 to 9 and 3 was > 9, during night on a scale of 0-2 defined as 0= none, 1=1 to 3 and 2 was >=4, defecation urgency on a scale of 0-3 defined as 0=none, 1=hurry, 2=immediately and 3=incontinence, blood in stool on a scale of 0-3 defined as 0= none, 1= trace, 2= occasionally frank and 3= usually frank, general well being on a scale of 0-4 defined as 0=very well, 1= slightly below par, 2= poor, 3 = very poor and 4= terrible, extracolonic features (arthritis, pyoderma gangrenosum, erythema nodosum, uveitis) on a scale of 0-1 defined as 0= absent, 1= present. The SCCAI score was calculated as a sum of scores for each individual component of the SCCAI. Minimum score 0, maximum score 19. Higher score implied worsening of symptoms. Participants were given a diary to score each component of SCCAI each morning. Average SCCAI scores over last 3 days were used for each Week.|Up to Week 6|ITT Population. Only those participants available at the specified time points were analyzed. Analysis was done on OC data referred to data collected on the electronic case report form (eCRF) without any imputations added.||Score on scale||Standard Error|Least Squares Mean
808806|NCT01036022|Primary|Mean Concentration of GSK1399686 in Colon Biopsy Obtained Within 24 h After the Last Dose|The assessment was done on the samples collected from the sigmoid colon and from the rectum obtained within 24 hour after the last dose on Week 4 visit after endoscopic evaluation of respective area for determination of GSK1399686 concentration. Non-quantifiable (NQ) concentration values were imputed as 0.|Week 4|Pharmacokinetic (PK) Population which was defined as the participants in the ITT Population for whom a PK sample was obtained and analysed. Only those participants available at the specified time points were analyzed.||Nanogram (ng)/mL||Standard Deviation|Mean
808807|NCT01036022|Primary|Mean Treatment Effects on Basal Morning Cortisol and Adrenocorticotropic Hormone (ACTH) Stimulated Cortisol Levels at Week 4 in Comparison With Baseline|Treatment effects was assessed using a low-dose ACTH stimulation test which was performed on Day 1 pre dose (Baseline) and at Week 4 visit. A blood sample for plasma cortisol was taken immediately, before and 30 minutes after an intravenous injection of 1 microgram (μg). tetracosactide acetate, a synthetic peptide displaying the same physiological properties as ACTH. The change from morning basal cortisol was calculated for Day 1 pre-dose (ACTH1) and Week 4 (ACTH2) using the equation: ACTH1 = Day 1 post ACTH - Day 1 pre ACTH; ACTH2 = Week 4 post ACTH - Week 4 pre ACTH. The change from morning basal cortisol between Week 4 and Day 1 (ACTH effect) was calculated as : ACTH effect = ACTH2 – ACTH1. The difference in morning basal cortisol between Week 4 and Day 1 (ACTH morning) was calculated as:- ACTH morning = Week 4 pre ACTH – Day 1 pre ACTH. Adrenocorticol function was classed as normal if the change from post ACTH to pre ACTH (using ACTH1 and ACTH2) was >= 200 nanomoles per liter.|Baseline (Day 1, pre dose) and Week 4|ITT Population. Only those participants available at the specified time points were analyzed.||Nanomoles per liter||Standard Error|Least Squares Mean
808808|NCT01036022|Primary|Number of Participants With Abnormal Electrocardiography (ECG) Findings|Single 12-lead ECGs were obtained at each timepoint during the study using an ECG machine that automatically calculated the HR and measured PR, QRS, QT, and QTc intervals. Criteria for ECG parameter values meeting PCI included absolute QTc interval >500 millisecond (msec); increase from Baseline QTc >60 msec; PR interval <110 and >220 msec; QRS interval <75 and >110 msec. Only those participants for whom at least one value of abnormal clinically significant or abnormal not clinically significant ECG findings were reported at any visit are summarized.|Screening (Day -7 to -1), Week 2, 4 and 6|ITT Population. Only those participants available at the specified time points were analyzed.||Participants|||Number
808809|NCT01036022|Primary|Number of Participants With Vital Sign Outside Range of Potential Clinical Importance (PCI)|Vital signs assessment included systolic blood pressure (SBP), Diastolic blood pressure (DBP) and heart rate (HR). Criteria for vital sign values meeting PCI included: SBP < 85 and > 160 millimeter of mercury (mmHg); DBP < 45 and > 100 mmHg and HR < 40 and > 110 beats per minute (bpm). The assessments were done on screening, Week 2, Week 4 and Week 6. The participants with values higher and lower than the PCI range is presented. Only those parameters for which at least one value of PCI was reported at any visit are summarized.|Screening (Day -7 to -1), Week 2, 4 and 6|ITT Population. Only those participants available at the specified time points were analyzed.||Participants|||Number
808810|NCT01036022|Primary|Number of Participants of Abnormal Urinalysis Dipstick Results|The urinalysis parameters included urine occult blood, urine general, glucose, ketones and protein by dipstick analysis. The assessments were done on screening, Week 2, Week 4 and Week 6.The number of participants with results of 0, 0.3, 1, 1+, 1.5, 10, 2+, 3+, 30, 4+, 5+, 55, not rated (NR), positive (pos) and trace is presented.|Screening (Day -7 to -1), Week 2, 4 and 6|ITT Population. Only those participants available at the specified time points were analyzed.||Participants|||Number
808811|NCT01036022|Primary|Number of Participants With Hematology Data Outside the Reference Range|Normal reference range for clinical chemistry parameters include: basophils 0 - 0.2 giga cells (GI)/L; eosinophils 0 - 0.4 GI/L; lymphocytes 1 - 4.8 GI/L; monocyte 0 - 0.8 GI/L; total neutrophils (total absolute neutrophils count) 1.8 - 7.7 GI/L; platelet count 150 – 400 GI/L; red blood cell count 4.5 - 5.9 GI/L; white blood cell count 3.9 - 10.6 GI/L; hemoglobin 135 – 175 g/L; hematocrit 0.41 - 0.53 ratio; mean corpuscle hemoglobin concentration 310 – 370 g/L; mean corpuscle hemoglobin 26 – 34 picogram (PG); mean corpuscle volume 80 – 100 femtoliter (FL); reticulocytes 0.05 - 0.1 trillion cells (TI)/L. Number of participants with high and low values compared to the reference range is presented. Only those parameters for which at least one value outside the reference range was reported at any visit are summarized.|Screening (Day -7 to -1), Day 1, Week 1, 2, 3, 4 and 6|ITT Population. Only those participants available at the specified time points were analyzed.||Participants|||Number
808812|NCT01036022|Primary|Number of Participants With Clinical Chemistry Data Outside the Reference Range|Normal reference range for clinical chemistry parameters include: alanine amino transferase (ALT) 0-41 international units per liter (IU/L); aspartate amino transferase (AST) 10 – 38 IU/L; alkaline phosphatase 40 – 129 IU/L; gamma glutamyl transferase (GGT) 10 – 66 IU/L; albumin 39 – 48 gram per liter (g/L); total protein 66 – 87 g/L; direct bilirubin 0 - 5.13 micromole per liter (µmol/L); total bilirubin 0 - 17.1 µmol/L; creatinine 61.88 - 106.08 µmol/L; uric acid 202.232 - 416.36 µmol/L; calcium 2.0958 - 2.42015 millimole per liter (mmol/L); cholesterol 2.8446 - 5.9478 mmol/L; chloride 98 – 106 mmol/L; glucose 2.2204 - 11.102 mmol/L; potassium 3.4 - 4.5 mmol/L; magnesium 0.6576 - 1.0686 mmol/L; sodium 0 - 2.26 mmol/L; urea/ blood urea nitrogen (BUN) 0 - 17.85 mmol/L. Number of participants with high and low values compared to the reference range is presented. Only those parameters for which at least one value outside the reference range was reported at any visit are summarized.|Screening (Day -7 to -1), Day 1, Week 1, 2, 3, 4 and 6|ITT Population. Only those participants available at the specified time points were analyzed.||Participants|||Number
808813|NCT01036022|Primary|Number of Participants With Any Adverse Events (AE) or Serious Adverse Events (SAE)|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, associated with liver injury and impaired liver function defined as alanine aminotransferase >=3 x upper limit of normal (ULN), and total bilirubin >=2 x ULN or international normalized ratio >1.5.|Up to Week 6|Intent-To-Treat (ITT) Population was defined as all participants who were randomized to treatment, who received at least one dose of study medication and who had at least one valid post dose assessment.||Participants|||Number
808814|NCT01036165|Secondary|Multiple Secondary Endpoints Will be Assessed, Based on Questions From the User Trial Questionnaire Related to the RebiSmart™ Autoinjector Use-related Outcomes.|The User Trial Questionnaire B was administered at Week 6 and Week 12 to assess the ease of use, functional reliability, overall satisfaction, satisfaction with device attributes, convenience, safety and portability of the Rebismart. Means and confidence intervals refer to the proportion of subjects responding positively, based on the number of non-missing values for each question. Secondary endpoints presented for decriptive purposes only thus no statistical analysis performed.|at Week 12|||Percentage of subjects||95% Confidence Interval|Mean
808815|NCT01036165|Primary|The Primary Endpoint is the Proportion of RMS Subjects Rating the RebiSmart™ Autoinjector as ‘Easy to Use’ or ‘Very Easy to Use’ for Self-injection in a User Trial Questionnaire.|Data from the User Trial Questionnaire-B, Question 13 (Overall, how do you rate your experience with using the injection device). Mean and confidence intervals refer to proportion of subjects responding positively to question. Missing values were replaced with worst case response.|at 12 Weeks|||Proportion of subjects||95% Confidence Interval|Mean
808826|NCT01036438|Secondary|Change in Inflammatory Signs|Change in inflammatory signs|4 weeks||||||
808827|NCT01036438|Primary|Efficacy Will be Defined as Absolute Wound Size Reduction.|Efficacy will be defined as absolute wound size reduction.|8 weeks|||cm2||Standard Deviation|Mean
808828|NCT01036490|Secondary|Change in Estimated Glomerular Filtration Rate (eGFR)||52 weeks minus baseline|||mL/min/1.73m^2||Standard Deviation|Mean
808829|NCT01036490|Secondary|Change in Estimated Glomerular Filtration Rate (eGFR)||12 weeks minus baseline|||mL/min/1.73m^2||Standard Deviation|Mean
808830|NCT01036490|Secondary|Change in Albuminuria||52 weeks minus baseline|||mg/g creatinine||Inter-Quartile Range|Median
808831|NCT01036490|Secondary|Change in Albuminuria||12 weeks minus baseline|||mg/g creatinine||Inter-Quartile Range|Median
808832|NCT01036490|Primary|Change in Proteinuria||52 weeks minus baseline|||mg/g creatinine||Inter-Quartile Range|Median
808833|NCT01036490|Primary|Change in Proteinuria||12 weeks minus baseline|||mg/g creatinine||Inter-Quartile Range|Median
808834|NCT01036529|Primary|Proportion of Subjects Showing ≥50% Self-reported Leg Pain Relief From Baseline Without Request for Crossover to the Other Treatment||3, 6- and 12- months post-index procedure|||proportion of participants|||Number
808835|NCT01038128|Primary|Brown Assessments of Belief Scale|The range for this scale is 0 to 28 units, with 0 representing the least ill and 28 representing the most ill.|Baseline to 12 weeks|This scale was only administered to participants with Body Dysmorphic Disorder. No participants with BDD completed the Baseline Visit and, therefore, no results were available to analyze.|||||
808836|NCT01038128|Primary|Body Dysmorphic Disorder Version of the Yale Brown Obsessive Compulsive Scale|The scale ranges from 0 to 91 units, with 0 representing the least ill and 91 representing the most ill.|Baseline to 12 weeks|One subject completed. The remaining two subjects' last observation was carried forward.||units on a scale||Standard Deviation|Mean
808837|NCT01038128|Primary|Clinical Global Impression Scale|Disorder severity is measured based on the Clinical Global Impression Scale. The scale ranges from 1 unit (Not at all ill) to 7 units (extremely ill).|Baseline to 12 weeks|One subject completed. The remaining two subjects' last observation was carried forward.||units on a scale||Standard Deviation|Mean
808838|NCT01038128|Primary|Ratings of Eating Pathology|"Ratings obtained from the self-induced vomiting and laxative misuse sections of the Eating Disorder Examination. The scale asks participants to calculate discreet episodes of self-induced vomiting and laxative misuses over the period of four weeks. Generally, the value obtained is the number of occurrences. However, in cases where the number of occurrences was too great to be calculated, the number 777 was used. The scale is therefore open-ended, with higher numbers coinciding with a greater number of episodes."|Baseline to 12 weeks|One subject completed. The remaining two subjects' last observation was carried forward.||units on a scale||Standard Deviation|Mean
808839|NCT01038128|Primary|Number of Binge Eating and Self-induced Vomiting Episodes|Number of self-reported binge eating and self-induced vomiting episodes during the week prior to the Baseline and Endpoint Visits.|Baseline to 12 weeks|One subject completed. The remaining two subjects' last observation was carried forward.||number of episodes||Standard Deviation|Mean
808843|NCT01038336|Secondary|Change in Cues to Action Score|Cues to action is a construct from the Health Belief Model defined as external influences that promote a health behavior (e.g. symptoms, media communications, or information from a healthcare provider). In the current study it refers to prompts from others about protecting hearing. Cues to action was assessed with 2 items in the Knowledge, Attitudes, and Behaviors Questionnaire (KAB; Saunders et al., 2014). Scores for each item are averaged and transformed onto a scale ranging from -50 to +50, with a higher score indicating greater cues to action, which according to the Health Belief Model will increase an individual's likelihood of engaging in a health behavior. Change in Cues to action was computed as the difference between baseline and 1-month follow-up scores, with a higher score indicating more Cues to action having been received at follow-up.|Baseline and 1 month|||Units on a scale||Standard Deviation|Mean
808844|NCT01038336|Secondary|Change in Perceived Self-efficacy Score|Perceived Self-efficacy is a construct from the Health Belief Model defined as an individual's assessment of his/her ability to successfully adopt a health behavior. In the current study it assesses the extent to which the individual believes that he/she has the knowledge and abilities to protect hearing. Perceived Self-efficacy was assessed with 4 items in the Knowledge, Attitudes, and Behaviors Questionnaire (KAB; Saunders et al., 2014). Scores for each item are averaged and transformed onto a scale ranging from -50 to +50, with a higher score indicating greater perceived self-efficacy, which according to the Health Belief Model, will increase an individual's likelihood of engaging in a health behavior. Change in Perceived Self-efficacy was computed as the difference between baseline and 1-month follow-up scores, with a higher score indicating greater perceived self-efficacy at follow-up.|Baseline and 1 month|||Units on a scale||Standard Deviation|Mean
808845|NCT01038336|Secondary|Change in Perceived Barriers Score|Perceived Barriers is a construct from the Health Belief Model defined as an individual's assessment of the influences that discourage adoption of a health behavior. In the current study it assesses the extent to which the individual perceives few negative influences to protecting hearing. Perceived Barriers was assessed with 3 items in the Knowledge, Attitudes, and Behaviors Questionnaire (KAB; Saunders et al., 2014). Scores for each item are averaged and transformed onto a scale ranging from -50 to +50, with a higher score indicating fewer perceived barriers, which according to the Health Belief Model will increase an individual's likelihood of engaging in a health behavior. Change in Perceived Barriers was computed as the difference between baseline and 1-month follow-up scores, with a higher score indicating fewer perceived barriers at follow-up.|Baseline and 1 month|||Units on a scale||Standard Deviation|Mean
808846|NCT01038336|Secondary|Change in Perceived Benefit Score|Perceived Benefit is a construct from the Health Belief Model defined as an individual's assessment of the positive consequences of adopting a health behavior. In the present study that is the belief that hearing well is important. Perceived Benefit was assessed with 7 items in the Knowledge, Attitudes, and Behaviors Questionnaire (KAB; Saunders et al., 2014). Scores for each item are averaged and transformed onto a scale ranging from -50 to +50, with a higher score indicating greater perceived benefit, which according to the Health Belief Model will increase an individual's likelihood of engaging in a health behavior. Change in Perceived benefit was computed as the difference between baseline and 1-month follow-up scores, with a higher score indicating greater perceived benefit at follow-up.|Baseline and 1 month|||units on scale||Standard Deviation|Mean
808847|NCT01038336|Secondary|Change in Perceived Severity Score|Perceived Severity is a construct from the Health Belief Model defined as an individual's assessment of the seriousness of the consequences of a condition if it is acquired. In the current study it assesses the extent to which the individual believes that a hearing loss would have negative consequences. Perceived Severity was assessed with 3 items in the Knowledge, Attitudes, and Behaviors Questionnaire (KAB; Saunders et al., 2014). Scores for each item are averaged and transformed onto a scale ranging from -50 to +50, with a higher score indicating greater perceived severity, which according to the Health Belief Model, will increase an individual's likelihood of engaging in a health behavior. Change in Perceived Severity was computed as the difference between baseline and 1-month follow-up scores, with a higher score indicating greater perceived severity at follow-up.|Baseline and 1 month|||Units on a scale||Standard Deviation|Mean
808848|NCT01038336|Secondary|Change in Perceived Susceptibility Score|Perceived Susceptibility is a construct from the Health Belief Model defined as an individual's assessment of the risk of acquiring a condition. In the current study it assesses the extent to which the individual feels vulnerable to hearing loss. Perceived Susceptibility was assessed with 5 items in the Knowledge, Attitudes, and Behaviors Questionnaire (KAB; Saunders et al., 2014). Scores for each item are averaged and transformed onto a scale ranging from -50 to +50, with a higher score indicating greater perceived susceptibility, which according to the Health Belief Model will increase an individual's likelihood of engaging in a health behavior. Change in Perceived Susceptibility was computed as the difference between baseline and 1-month follow-up scores, with a higher score indicating greater perceived susceptibility at follow-up.|Baseline and 1 month|||Units on a scale||Standard Deviation|Mean
808849|NCT01038336|Secondary|Knowledge About Hearing Conservation Scale|Knowledge about hearing conservation was assessed with 16 items in the the Knowledge, Attitudes, and Behaviors Questionnaire (KAB; Saunders et al., 2014). It is a validated questionnaire that assesses knowledge about and attitudes toward hearing and hearing loss prevention. The Knowledge scale is scored as a percent correct, with a higher score indicating more knowledge. Data presented are for change in knowledge between baseline and 1-month follow-up computed such that a higher score indicates greater increase in knowledge.|Baseline and 1 month|||percent of correct answers||Standard Deviation|Mean
808850|NCT01038336|Primary|Percentage of Time Spent at Sound Levels >80 Decibels|Objective measure of noise exposure using dosimeter to measure the percentage of time over 7days spent in sound levels >80 decibels|1 month|||percentage of time||Standard Deviation|Mean
808851|NCT01038609|Secondary|Number of Participants With Chemistry Values Meeting Potentially Clinically Significant Criteria|Potentially clinically significant criteria: alanine aminotransferase/aspartate aminotransferase (ALT/AST) ≥3 times upper limit of normal (ULN); calcium ≤1.8 mmol/L.|At specified intervals from Screening through 7 days after first dose of study drug|All randomized participants who received at least 1 dose of study drug. Analyses were performed based on the treatment participants actually received (as-treated).||participants|||Number
810312|NCT01050764|Secondary|Acute Graft-versus-Host-Disease (aGvHD)|The primary outcome was incidence of grade 3 or 4 acute graft-vs-host-disease (aGvHD), reported as the number of participants developing grade 3 or 4 aGvHD.|1 year|Population of participants that received HSCT and T-reg plus T-con||Participants|||Count of Participants
808852|NCT01038609|Secondary|Number of Participants With Vital Signs Values Meeting Potentially Clinically Significant Criteria|Potentially clinically significant criteria: Systolic blood pressure (BP) ≤90 mm Hg and ≥20 mm Hg decrease (low) or ≥180 mm Hg and ≥20 mm Hg increase (high); Diastolic BP ≤50 mm Hg and ≥15 mm Hg decrease (low) or ≥105 mm Hg and ≥15 mm Hg increase (high). Heart rate ≤50 beats per minute (bpm) and ≥15 bpm decrease (low) or ≥120 bpm and ≥15 bpm increase (high). Respiratory rate <10 respirations per minute (rpm) (low) or >24 rpm (high).|At specified intervals from Screening through 7 days after first dose of study drug|All randomized participants who received at least 1 dose of study drug. Analyses were performed based on the treatment participants actually received (as-treated).||participants|||Number
808853|NCT01038609|Secondary|Participants With Adverse Events (AEs)|An adverse event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with treatment. If an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE): results in death or is life-threatening, results in admission or prolongation of hospitalization, results in congenital anomaly or persistent or significant disability/incapacity, or is an important medical event requiring medical or surgical intervention to prevent serious outcome. AEs were categorized by severity (mild, moderate, severe) and relationship to treatment (probably, possibly, probably not, not related). Please see Adverse Events section below for more details.|AEs were recorded from study drug administration until 30 days following discontinuation of study drug (total 32 days); SAEs were recorded from the time informed consent was obtained until 30 days following discontinuation of study drug (total 51 days).|All randomized participants who received at least 1 dose of study drug. Analyses were performed based on the treatment participants actually received (as-treated).||participants|||Number
808854|NCT01038609|Secondary|Time to Perceptible and Meaningful Pain Relief|The median time (minutes) from first perceptible pain relief (onset of pain relief) and time until first meaningful pain relief.|From time of first study drug administration to 12 hours following first study drug administration|All randomized participants who received at least 1 dose of study drug. Analyses were performed based on the treatment participants actually received (as-treated).||minutes||95% Confidence Interval|Median
808855|NCT01038609|Secondary|Participant's Global Assessment of Study Drug|The participant's overall impression of the study drug was obtained on a 5-point categorical scale: excellent; very good; good; fair; poor.|From time of first study drug administration to 48 hours following first study drug administration|All randomized participants who received at least 1 dose of study drug. Analyses were performed based on the treatment participants actually received (as-treated).||participants|||Number
808856|NCT01038609|Secondary|TOTPAR (Total Pain Relief)|TOTPAR was the time-interval weighted sum of pain relief. Pain relief was assessed by participants’ responses to how their pain relief was compared with the pain they had just before receiving the first dose of study drug: no relief, a little relief, some relief, a lot of relief, or complete relief. Higher mean TOTPAR scores indicate better pain relief. The TOTPAR score is a measure of the cumulative pain intensity difference during treatment and the area under the curve was estimated using the linear trapezoidal rule.|From time of first study drug administration to 48 hours following first study drug administration|All randomized participants who received at least 1 dose of study drug. Analyses were performed based on the treatment participants actually received (as-treated).||scores on a scale||Standard Error|Least Squares Mean
808857|NCT01038609|Primary|Sum of Pain Intensity Difference (SPID) Using the Pain Intensity Visual Analogue Scale (VAS)|"Participants assessed pain intensity on a 100 mm visual analogue scale (VAS) with 0 meaning no pain and 100 meaning the worst pain imaginable. The SPID VAS score for 0 to 48 hours following initial study drug dose measured the cumulative pain intensity difference during treatment with higher mean SPID VAS scores indicating greater improvement from Baseline. The SPID score is a measure of the cumulative pain intensity difference during treatment and the area under the curve was estimated using the linear trapezoidal rule."|From time of first study drug administration to 48 hours following first study drug administration|All randomized participants who received at least 1 dose of study drug. Analyses were performed based on the treatment participants actually received (as-treated).||scores on a scale||Standard Error|Least Squares Mean
808858|NCT01038635|Secondary|Overall Response: Number of Participants With CR or CRi Response|Response defined as complete remission (CR) or complete remission with incomplete platelet recovery (CRi) for AML or any response for myelodysplastic syndrome (MDS) using international working group (IWG)-06 criteria. Complete response (CR) requires normalization of peripheral counts (absolute neutrophil count 10^9/L or more, platelet count 100 x 10^9/L or more), and a bone marrow with 5% or less marrow blasts. A hematologic improvement (HI) is defined as a CR with a platelet count above 30 x 10^9/L, without the need for transfusion of Platelets.|6 months|||participants|||Number
808859|NCT01038635|Secondary|Overall Response Rate (ORR) of Lenalidomide in Combination With 5-azacytidine (5-AZA) in Participants With Leukemia|Response defined as complete remission (CR) or complete remission with incomplete platelet recovery (CRi) for AML or any response for myelodysplastic syndrome (MDS) using international working group (IWG)-06 criteria. Complete response (CR) requires normalization of peripheral counts (absolute neutrophil count 10^9/L or more, platelet count 100 x 10^9/L or more), and a bone marrow with 5% or less marrow blasts. A hematologic improvement (HI) is defined as a CR with a platelet count above 30 x 10^9/L, without the need for transfusion of Platelets.|6 months|||percentage of participants|||Number
808860|NCT01038635|Primary|Number of Dose Limiting Toxicities for Determining Maximum Tolerated Dose (MTD) of Lenalidomide in Combination With 5-azacytidine (5-AZA)|DLT determined only during first course of therapy, at least 28 days from treatment of last participant before a new dose level initiated. All severe (Grade 3-4) non-hematological toxicities that are drug related considered for DLT determination. If 1 participant develops grade III-IV non-hematological toxicity, 3 more will be accrued at that particular dose level. If 2 or more participants develop grade III-IV non-hematologic toxicity, the doses of the combination at which this occurs will be considered too toxic. A total of 10 patients will be treated at the maximally tolerated dose (MTD) of the combination (the dose level below that considered to be too toxic) to confirm its tolerability.|3-8 week cycles, up to 24 weeks|||participants|||Number
808861|NCT01038713|Secondary|Assess Rate of Acute Cholecystitis Associated With Each Type of Stent||time from stent placement to 500 days|||Participants|||Number
808862|NCT01038713|Secondary|Assess Days Neoadjuvant Therapy Was Delayed Due to Complications Associated With the Stents|Total number of days in which neoadjuvant therapy was delayed due to stent related issues|Time from stent placement to 500 days|||Days|||Number
808865|NCT01038713|Primary|Assess the Occlusion Rates, Attempted Surgical Resection or Death of Plastic, Covered, and Uncovered Biliary Stents in Patients Presenting With Malignant Biliary Obstruction.|Number of participants who developed stent occlusion, attempted surgical resection or death following stent placement|Time of stent occlusion, attempted surgical resection or patient death to 300 days|||participants|||Number
808866|NCT01038752|Secondary|To Determine Whether Adding Non-cytotoxic Suramin to Docetaxel and Carboplatin Produces Greater Survival Benefits in African-American Patients Compared to Non-African-American Patients.|Insufficient data.|Randomization date to date of death|Because 6 of 14 participants were lost to follow up before progression, analysis was not performed.|||||
808867|NCT01038752|Secondary|To Determine Whether Adding Non-cytotoxic Suramin to Docetaxel and Carboplatin Produces Survival Benefits in African-American Patients.|Insufficient data.|Randomization date to date of death|Because 6 of 14 participants were lost to follow up before progression, analysis was not performed.|||||
808868|NCT01038752|Secondary|Survival Benefit From Non-cytotoxic Suramin Association With Reduced M-phase Entry in Peripheral Blood Lymphocytes|Insufficient data.|Randomization date|Because 6 of 14 participants were lost to follow up before progression, analysis was not performed.|||||
808869|NCT01038752|Secondary|Pre-treatment bFGF Levels Correlation With Survival.|Insufficient data.|Before first treatment|Because 6 of 14 participants were lost to follow up before progression, analysis was not performed.|||||
808870|NCT01038752|Secondary|Toxicity of Combination of Non-cytotoxic Suramin With Docetaxel and Carboplatin.|Insufficient data.|Day 1 of each cycle; end of treatment visit; at follow-up.|Because 6 of 14 participants were lost to follow up before progression, analysis was not performed.|||||
808871|NCT01038752|Secondary|Overall Response Rate (Complete Response + Partial Response) of Participants|Insufficient data|Tumor assessment at every other cycle|Because 6 of 14 participants were lost to follow up before progression, analysis was not performed.|||||
808872|NCT01038752|Secondary|Overall Survival of Participants|Insufficient Data|First treatment date to date of death|Because 6 of 14 participants were lost to follow up before progression, analysis was not performed.|||||
808873|NCT01038752|Primary|Progression-free Survival for Participants With Stage IIIB/IV NSCLC Per RECIST Criteria|Insufficient data|Patients will be followed every 2 months for the first 6 months following the last cycle of treatment, every three months for the next year, and every 6 months thereafter.|Because 6 of 14 participants were lost to follow up before progression, analysis was not performed.|||||
808874|NCT01038869|Secondary|Tolerability Assessments as Measured by the Number of Participants With Side Effects|Tolerability parameters assesssed by the presence and degree of peeling, erythema, dryness, oiliness, burning and pruritus|16 weeks|per protocol||participants|||Number
808875|NCT01038869|Secondary|Percentage Change in Total Lesion Counts|Total lesions including inflammatory lesions (papules, pustules, nodules) and non-inflammatory lesions (open and closed comedones).|Baseline to 16 weeks|per protocol||percentage of total lesion count||Standard Deviation|Mean
808876|NCT01038869|Secondary|Percentage of Participants With an Improvement in Post Inflammatory Hyperpigmentation (PIH) % Distribution|The % distribution of PIH, evaluated on a scale of 0 = no PIH through 6 = greater than 50%|Baseline to 16 weeks|per protocol||percentage of participants|||Number
808877|NCT01038869|Secondary|Percentage of Participants With Improvement in the IGA of Post Inflammatory Hyperpigmentation(PIH)|IGA for PIH assessed on a 7 point scale (0= clear through 6 = severe) with at least a two point improvement|Baseline to16 weeks|per protocol||percentage of participants|||Number
808878|NCT01038869|Primary|Percentage of Participants With Improvement in Acne IGA (Investigator Global Assessment)|IGA Assessments at each visit (baseline and follow up) based on a 6 point scale (0= clear through 5 = very severe). Improvement is defined as at least a 1 point improvement.|Baseline to 16 weeks|Per protocol||percentage of participants|||Number
808879|NCT01038921|Primary|Metabolic Syndrome Components||3 years|||mmHg||Standard Deviation|Mean
808880|NCT01039207|Other Pre-specified|Circulating Levels of Markers of Angiogenesis|Exploratory analyses will be conducted to assess the possible effects of the study regimen on the biomarkers of interest as well as associations between the biomarkers and clinical outcome (such as PFS and OS).|Up to 1 day prior to course 2||||||
808881|NCT01039207|Other Pre-specified|Circulating Levels of HGF/Scatter Factor (SF)|Exploratory analyses will be conducted to assess the possible effects of the study regimen on the biomarkers of interest as well as associations between the biomarkers and clinical outcome (such as PFS and OS).|Up to 1 day prior to course 2||||||
808882|NCT01039207|Other Pre-specified|Biomarker Panel From Tumor Tissue|A panel of biomarkers from fixed and embedded tumor tissue will be tested for association with measures of response to treatment including PFS and OS.|Baseline||||||
808883|NCT01039207|Secondary|Duration of Progression-free Survival (PFS)|Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression was based on RECIST 1.1. RECIST 1.1 defines progressive disease as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions or unequivocal progression of non-target lesions is also considered progression.|CT scan or MRI if used to follow lesion for measurable disease every other cycle during treatment then every 3 months thereafter until disease progression is confirmed; also repeat at any time if clinically indicated up to 5 years.|Eligible and treated patients||months||90% Confidence Interval|Median
808884|NCT01039207|Secondary|Duration of Overall Survival (OS)|Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.|Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years.|Eligible and treated patients. Measure type = The first quartile of the distribution since follow-up time is insufficient to obtain adequate median estimates.||months||90% Confidence Interval|Number
808885|NCT01039207|Secondary|Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 4.0|Number of participants with a maximum grade of 3 or higher during the treatment period.|Assessed every cycle while on treatment, 30 days after the last cycle of treatment|Eligible and treated patients.||participants|||Number
808886|NCT01039207|Primary|Progression-free Survival > 6 Months Using RECIST 1.0|Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression was based on RECIST 1.1. RECIST 1.1 defines progressive disease as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions or unequivocal progression of non-target lesions is also considered progression.|CT scan or MRI if used to follow lesion for measurable disease every other cycle during treatment then every 3 months thereafter until disease progression is confirmed; up to 6 months.|Eligible and treated patients||participants|||Number
808887|NCT01039207|Primary|Proportion of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.1|Complete and Partial Tumor Response by RECIST 1.1. RECIST 1.1 defines complete response as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm and the disappearance of all non-target lesions and normalization of tumor marker level. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Only those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.|CT scan or MRI if used to follow lesion for measurable disease every other cycle during treatment then every 3 months thereafter until disease progression is confirmed; also repeat at any time if clinically indicated up to 5 years.|Eligible and treated patients.||participants|||Number
808888|NCT01039376|Secondary|Plasma Half-life (t1/2) of Ofatumumab|The terminal half life (t1/2) of ofatumumab is defined as the time required for the plasma concentration of ofatumumab to reach half of its original value.|Day 1 of Month 1 (Cycle 1 Week 1); Day 8 of Month 1 (Cycle 1 Week 2); and Month 7 (Cycle 4)|PK Population. Only those participants available at the indicated time points (indicated by n=X in the category titles) were analyzed.||hours||Geometric Coefficient of Variation|Geometric Mean
808889|NCT01039376|Secondary|Vss of Ofatumumab|Volume of distribution at steady state (Vss) is defined as the apparent volume of distribution of a drug between plasma and the rest of the body at steady state. Data from all time points collected were used to calculate one Vss value for each individual.|Day 1 Month 1 ( Cycle 1) through Month 25 ( Cycle 13)|PK Population. Only those participants available at the indicated time points were analyzed.||Liters (L)||Geometric Coefficient of Variation|Geometric Mean
808890|NCT01039376|Secondary|AUC(0-tau) of Ofatumumab|Area under the concentration time curve over the dosing interval (AUC[0-tau]) is a measure of the drug exposure over time.|Day 1 of Month 1 (Cycle 1 Week 1); Day 8 of Month 1 (Cycle 1 Week 2); and Month 7 (Cycle 4)|PK Population. Only those participants available at the indicated time points (indicated by n=X in the category titles) were analyzed.||micrograms*hour per mL (µg*hour/mL)||Geometric Coefficient of Variation|Geometric Mean
808891|NCT01039376|Secondary|Total Plasma Clearance (CL) of Ofatumumab|Plasma clearance is defined as the plasma volume that is cleared of drug per unit of time.|Day 1 of Month 1 (Cycle 1 Week 1); Day 8 of Month 1 (Cycle 1 Week 2); and Month 7 (Cycle 4)|PK Population. Only those participants available at the indicated time points (indicated by n=X in the category titles) were analyzed.||millileters per hour (mL/hour)||Geometric Coefficient of Variation|Geometric Mean
808892|NCT01039376|Secondary|Cmax and Ctrough of Ofatumumab|Blood samples were collected to assess the plasma concentration of ofatumumab. Maximum concentration (Cmax) and observed drug concentration prior to the next dose (Ctrough) were determined. Blood samples were collected at pre-dose and 0.5 hours after the end of the infusion at treatment on Month 1 Week 1 (Day 1), Month 1 Week 2 (Day 8), and at every second infusion.|Day 1 of Month 1 (Cycle 1 Week 1); Day 8 of Month 1 (Cycle 1 Week 2); and Month 7 (Cycle 4)|Pharmacokinetic (PK) Population: all participants in the ITT Population for whom a PK sample was obtained and analyzed. Only those participants available at the indicated time points (indicated by n=X in the category titles) were analyzed.||micrograms per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
808893|NCT01039376|Secondary|Summary of Covariates to Compute Cox Proportional Hazards Regression Model for Relationship Between Investigator Assessed Progression-free Survival and the Indicated Prognostic Markers|Blood samples were collected for the assessment of the following prognostic markers at Baseline (BL) and upon relapse: immunoglobulin heavy chain variable region (IgVH) mutational status; VH3-21 usage; Cytogenetics (by fluorescent in situ hybridization [FISH]) including 6q-, 11q-, +12q, 17p-, 13q- deletions; beta 2 microglobulin. Cox-regression model was used to explore the relationship between progression-free survival and the following explanatory variables: treatment group, cytogenetics (analyzed by FISH) at BL, IgVH mutational status at BL, beta 2 microglobulin at BL, BL CD20 and BL complement level. For each covariate, a hazard ratio <1 indicates a lower risk on the first effect tested compared with the other effects tested. Cytogenetics Group (based on >=20%)=CY G.|From Baseline until the end of the study (up to 84 months)|ITT Population||Participants|||Number
808894|NCT01039376|Secondary|Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points|CD5+CD19+ cells were counted by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus. Baseline CD5+CD19+ and CD5-CD19+ cell count value is the last pre-dose assessment values performed on Cycle 1 Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and every two months from Month 3 until Month 25 and at every follow-up visit (up to 84 months)|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population.||Cells per microliter||Standard Deviation|Mean
808895|NCT01039376|Secondary|Number of Participants Who Were Positive and Negative for Minimal Residual Disease (MRD) at Any Visit|MRD refers to small number of leukemic cells that remain in the participant during treatment or after treatment at the time the participant achieved a confirmed complete remission. Number of participants who were positive and negative for minimal residual disease (MRD) at any visit is presented.|From randomization until the end of the study (up to 84 months)|ITT Population. Only those participants with data available at the specified time point were analyzed.||Participants|||Number
808896|NCT01039376|Secondary|Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points|Immunoglobulins, or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Low levels indicate immuno-suppression. IgA, IgG, and IgM were measured in the blood samples of the participants. Baseline IgA, IgG, and IgM values are the last pre-dose assessment values performed on Cycle 1 Day 1. Change from Baseline was calculated as the post-baseline value minus the Baseline value. Immunoglobulins were measured at the following time points: Baseline (BL) and Cycle (C) 2 Week (W) 9/Month (M) 3, C3 W17/M5, C4 W25/M7, C5 W33/M9, C6 W41/M11, C7 W49/M13, C8 W57/M15, C9 W65/M17, C10 W73/M19, C11 W81/M21, C12 W89/M23, C13 W97/M25, 3M Follow-up (FU), 6M FU, 9M FU, 12M FU, 15M FU, 18M FU, 21M FU and Withdrawal (WDL) were presented.|Baseline, every six months during treatment, and after last treatment visit and/or upon relapse (up to 24 months)|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.||grams per liter||Standard Deviation|Mean
808897|NCT01039376|Secondary|Number of Participants With a Positive Anti-ofatumumab Antibody (Human Anti-human Antibody; HAHA) Result|All serum samples for analysis of HAHA were first tested in a screening step; positive samples from the screening were further evaluated in a confirmation test. The confirmed positive samples were reported as HAHA positive and further evaluated in the titration test to obtain a titer of HAHA. A confirmed positive result at any time point means the participant is positive for HAHA.Results are reported as the number of participants positive for HAHA.|Pre-dose (Visit 1), Months 7, 13, 19, and 25 during treatment and at 3 and 6 months after last ofatumumab dose (up to 30 months)|Safety Population. Only those participants with post-ofatumumab HAHA results were analyzed.||Participants|||Number
808898|NCT01039376|Secondary|Number of Participants Diagnosed With Autoimmune Hemolytic Anemia (AIHA)|"AIHA is a disease where the body's immune system fails to recognize red blood cells as self and begins destroying these red blood cells. The number of participants diagnosed with AIHA are presented."|From randomization until the end of the study (up to 24 months)|Safety Population||Participants|||Number
808899|NCT01039376|Secondary|Number of Participants Who Received at Least One Transfusion During the Study|Participants who received at least one transfusion (any blood products or blood supportive care product) during the study are presented.|From randomization until the end of the study (up to 24 months)|Safety Population||Participants|||Number
808900|NCT01039376|Secondary|Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points|Myelosuppression is defined as the decrease in the ability of the bone marrow to produce blood cells. Number of participants who reported myelosuppression (anemia [low hemoglobin count], neutropenia [low neutrophil count], and thrombocytopenia [low platelet count]) are presented. AEs were graded according to NCI common terminology criteria for adverse events (CTCAE) grade, version 4.0 (1, mild; 2, moderate; 3, severe; 4, life-threatening/disabling; 5, death). Assessment was at the following time points: Screening, C1 W1/M1, C1 W2/M1, C2 W9/M3, C3 W17/M5, C4 W25/M7, C5 W33/M9, C5 unscheduled, C6 W41/M11, C6 unscheduled, C7 W49/M13, C8 W57/M15, C8 unscheduled, C9 W65/M17, C10 W73/M19, C11 W81/M21,C11 unscheduled, C12 W89/M23, C13 W97/M25, 3M, 6M, 9M, 12M FU and WDL.|From first dose of study medication until 60 days after the last dose of study medication or until the last observation at Visit 14 (up to 24 months)|Safety Population.Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.||Participants|||Number
808901|NCT01039376|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.|From first dose of study medication until 60 days after the last dose of study medication or until the last observation at Visit 14 (up to 24 months for non-serious AEs and 84 months for SAEs)|Safety Population||Participants|||Number
808902|NCT01039376|Secondary|Number of Participants With Grade 3 and Above Adverse Event of Infection|Participants with Grade 3, Grade 4 and Grade 5 adverse event of infection are presented. Adverse events were graded according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) grade, version 4.0 (1=mild; 2=moderate; 3=severe; 4=life-threatening/disabling; 5=death).|From first dose of study medication until 60 days after the last dose of study medication or until the last observation at Visit 14 (up to 84 months)|Safety Population: all participants who were randomized in the study and analyses were done based on the treatment the participant received regardless of how they were randomized.||Participants|||Number
808903|NCT01039376|Secondary|Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points|Par. with the indicated constitutional or B-symptoms (night sweats [without signs of infection]; unintentional weight loss >= 10% within the previous 6 months; recurrent, unexplained fever of > 38 degrees celcius or 100.5 degrees fahrenheit for 2 weeks; and extreme fatigue) were presented. The proportion of par. with no night sweats, no weight loss, no fever and no extreme fatigue were summarized and compared to the proportion of par. with >= 1 of the following: night sweats, weight loss, fever or extreme fatigue. The proportions were compared between treatment groups with the Cochran-Mantel-Haenszel test adjusting for stratification factors (response at entry, number of prior treatments and type of prior treatment). B-symptoms were assessed at the following time points: Screening, C1 W1/M1, C2 W9/M3, C3 W17/M5, C4 W25/M7, C5 W33/M9, C6 W41/M11, C7 W49/M13, C8 W57/M15, C9 W65/M17, C10 W73/M19, C11 W81/M21, C12 W89/M23, C13 W97/M25, 3M, 6M, 9M, 12M, 15M, 18M, 21M FU and WDL.|From Screening until the end of the study (up to 84 months)|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population.||Participants|||Number
808904|NCT01039376|Secondary|Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points|Improvement is defined as a decrease from Baseline by at least one step on the ECOG performance status scale (improvement categorized as yes or no). The proportion of participants with improvement was compared between treatment groups with the Cochran-Mantel-Haenszel test adjusting for stratification factors (response at entry, number of prior treatments and type of prior treatment). Improvement in ECOG performance status was measured at the available time points that have data: Cycle (C) 1 Week (W) 2/Month (M) 1, C2 W9/M3, C3 W17/M5, C4 W25/M7, C5 W33/M9, C6 W41/M11, C7 W49/M13, C8 W57/M15, C9 W65/M17, C10 W73/M19, C11 W81/M21, C12 W89/M23, C13 W97/M25, 3M Follow-up (FU), 6M FU, 9M FU, 12M FU, 15M FU, 18M FU, 21M FU and Withdrawal (WDL).|From randomization until the end of the study (up to 84 months)|ITT Population. Only those participants available at the specified time points were analyzed.||Participants|||Number
808905|NCT01039376|Secondary|Change From Baseline in the Quality of Life Status as Assessed by the EuroQol-5D (EQ-5D) Scale|EQ-5D is comprised of a 5-item health status measure and a visual analogue scale (VAS) and is used to generate two scores: the utility score and the thermometer score. The utility score measures mobility, self-care, usual activities, pain, discomfort, and anxiety/depression. Responses to each of the 5 health states are measured on a 3-point scale (level 1 = no problem; level 2 = some or moderate problem[s] and level 3 = unable, or extreme problems). Responses are typically converted into health utilities or valuations on a scale ranging from 0 (worst health) to 1 (perfect health). The thermometer score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). Changes from Baseline were analyzed by mixed model-repeated measures ANCOVA. A negative adjusted mean change from Baseline represents a worsening of quality of life.|From randomization until the end of the study (up to 84 months)|ITT Population||Scores on a scale||Standard Deviation|Mean
808906|NCT01039376|Secondary|Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score|"The EORTC QLQ-C30 is a self-reported, 30-item cancer-specific instrument that assesses 15 domains: physical functioning (5 items), role functioning (2 items), emotional functioning (4 items), cognitive functioning (2 items), social functioning (2 items), pain (2 items), fatigue (3 items), nausea and vomiting (2 items), five single-item symptom scores (insomnia, loss of appetite, constipation, diarrhea, and dyspnea), a single item asking about financial difficulties, and global health status/quality of life (QOF) consisting of 2 items. Functional and symptoms scales were measured on a four-point Likert scale, where 1 = not at all and 4 = very much, whereas global health status or QOF was assessed using a 7-item Likert scale, ranging from poor (worse quality of life) to excellent (better quality of life). Changes from Baseline were analyzed by mixed model-repeated measures ANCOVA."|From randomization until the end of the study (up to 84 months)|ITT Population||Scores on a scale||Standard Deviation|Mean
808907|NCT01039376|Secondary|Change From Baseline (BL) in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)|The EORTC QLQ-CLL16 is comprised of 16 questions that address 5 domains of health-related quality of life (HRQoL) important in CLL. There are 4 multi-item scales – fatigue (2 items), treatment side effects ([TSE], 4 items), disease symptoms (disease effects scale [DES], 4 items), and infection (4 items) – and single-item scales (social activities [Social Problems (SP) Scale] and future health worries [Future Health (FH) Scale]). These are measured on a four-point Likert scale, where 1 = not at all and 4 = very much. These scores are transformed to give a rating from 0 – 100, where 0 = no symptoms or problems and 100 = severe symptoms or problems. Changes from Baseline were analyzed by a mixed model-repeated measures analysis of covariance (ANCOVA).|From randomization until the end of the study (up to 84 months)|ITT Population||Scores on a scale||Standard Deviation|Mean
808908|NCT01039376|Secondary|Time to Progression After Next-line Therapy|Time to progression after next-line therapy is defined as the time from progression following randomization until progression or death following next-line therapy and counted as events deaths prior to next-line therapy. Participants who received next-line therapy with a PD prior to receiving next line therapy and who did not had progression or death after next-line therapy were censored at their last date of contact. If a participant died prior to next-line therapy, this was counted as an event.|From randomization until progression or death (up to 84 months)|ITT Population. Only participants who received next-line therapy and who also had PD prior to next line therapy were analysed. Participants who died prior to next-line therapy were also included for analysis.||Months||95% Confidence Interval|Median
808909|NCT01039376|Secondary|Progression-free Survival After Next-line Therapy|Progression-free survival after next-line therapy is defined as the time from randomization until progression or death following the next-line therapy and counted as events deaths prior to next-line therapy. Participants who received next-line therapy and who did not have progression or death after next-line therapy were censored at their last date of contact. Participant who died prior to next-line therapy, was counted as an event.|From randomization until progression or death (up to 84 months)|ITT Population. Only participants who received next-line therapy and subjects who died prior to receiving next-line therapy were analyzed.||Months||95% Confidence Interval|Median
808910|NCT01039376|Secondary|Time to Next Therapy|Time to next therapy is defined as the time from randomization to the date of receiving the next CLL treatment.|From randomization until the end of the study (up to 84 months)|ITT Population||Months||95% Confidence Interval|Median
808911|NCT01039376|Secondary|Number of Participants With Improvement in Response From Baseline|Improvement in response was assessed by calculating the percentage of participants who changed from partial response (PR) at Baseline to complete response during the study.|From Baseline until the end of the study (up to 24 months)|ITT Population. Only participants who had PR at study entry were analyzed.||Participants|||Number
808912|NCT01039376|Secondary|Overall Survival|Overall survival is defined as time from randomization to date of death.|From randomization until death (up to 84 months)|ITT Population||Months||95% Confidence Interval|Median
808925|NCT01039519|Secondary|Percentage of Participants Showing a Tumor Response During Cycle 1 in Selected Participants Measured by Positron Emission Tomography (PET)|PET imaging was completed on selected patients only from one investigative site. Treatment phase PET and biopsy was completed on any day from Cycle 1 Day 2 through Day 10. PET imaging data were analyzed utilizing the European Organization for Research and Treatment of Cancer (EORTC) PET Study Group guidelines [Young H, Eur J Cancer, 1999]. Tumor response was considered a complete response (CR) or a partial response (PR).|Day 2 to Day 10|Participants from one investigative site who provided consent for the PET/CT imaging.||percentage of participants|||Number
808913|NCT01039376|Primary|Progression-free Survival, as Assessed by the Independent Review Committee (IRC)|Progression-free survival is defined as the time from randomization to the date of disease progression (PD) or death due to any cause. PD was determined by the IRC according to the definitions of response in the International Workshop for Chronic Lymphocytic Leukemia (IWCLL) updated National Cancer Institute-Sponsored Working Group (NCI-WG) guidelines. According to the guidelines, PD is characterized by at least one of the following: lymphadenopathy (appearance of any new lesion such as enlarged lymph nodes (>1.5 centimeter [cm]), spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site); an increase by 50% or more in the previously noted enlargement of the liver or spleen; an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter; transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukemia.|From randomization until progression or death (up to 84 months)|Intent-to-Treat (ITT) Population: all participants who were randomized in the study.||Months||95% Confidence Interval|Median
808914|NCT01039376|Primary|Progression-free Survival, as Assessed by the Investigator|Progression-free survival is defined as the time from randomization to the date of disease progression (PD) or death due to any cause. PD was determined by the investigator according to the definitions of response in the International Workshop for Chronic Lymphocytic Leukemia (IWCLL) updated National Cancer Institute-Sponsored Working Group (NCI-WG) guidelines. According to the guidelines, PD is characterized by at least one of the following: lymphadenopathy (appearance of any new lesion such as enlarged lymph nodes (>1.5 centimeter [cm]), spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site); an increase by 50% or more in the previously noted enlargement of the liver or spleen; an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter; transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukemia.|From randomization until progression or death (up to 84 months)|Intent-to-Treat (ITT) Population: all participants who were randomized in the study.||Months||95% Confidence Interval|Median
808915|NCT01039428|Secondary|Serum Intact Fibroblast Growth Factor (FGF) 23 Level|Serum intact FGF23 levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday).|week 3|Per Protocol Set included randomized participants who completed the entire clinical trial and were counted towards the final results. The endpoint was analyzed only for those participants who had data for this outcome measure.||log10(pg/mL)||Standard Deviation|Mean
808916|NCT01039428|Secondary|Serum Intact Parathyroid Hormone (PTH) Level|Serum intact and whole PTH levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday).|week 3|Per Protocol Set included randomized participants who completed the entire clinical trial and were counted towards the final results. The endpoint was analyzed only for those participants who had data for this outcome measure.||pg/mL||Standard Deviation|Mean
808917|NCT01039428|Secondary|Ca×P|Serum inorganic phosphorus and Ca levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday).|week 3|Per Protocol Set included randomized participants who completed the entire clinical trial and were counted towards the final results. The endpoint was analyzed only for those participants who had data for this outcome measure.||mg/mL*mg/mL||Standard Deviation|Mean
808918|NCT01039428|Secondary|Corrected Serum Calcium (Ca) Level Based on the Serum Albumin Level Corrected Serum Calcium (mg/dL) = Measured Total Ca (mg/dL) + (4 - Serum Albumin [g/dL])|Serum Ca levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday).|week 3|Per Protocol Set included randomized participants who completed the entire clinical trial and were counted towards the final results. The endpoint was analyzed only for those participants who had data for this outcome measure.||mg/dL||Standard Deviation|Mean
808919|NCT01039428|Secondary|Salivary Inorganic Phosphorus Level|Salivary inorganic phosphorus levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday).|week 3|Per Protocol Set included randomized participants who completed the entire clinical trial and were counted towards the final results. The endpoint was analyzed only for those participants who had data for this outcome measure.||mg/dL||Standard Deviation|Mean
808920|NCT01039428|Secondary|Serum Inorganic Phosphorus Level|Serum inorganic phosphorus levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday).|week 3|Per Protocol Set included randomized participants who completed the entire clinical trial and were counted towards the final results. The endpoint was analyzed only for those participants who had data for this outcome measure.||mg/dL||Standard Deviation|Mean
808921|NCT01039428|Secondary|Achievement Number of Participants With Serum Inorganic Phosphorus; 3.5 ≦P＜5.5 mg/dL at Week 3||week 3|Per Protocol Set included randomized participants who completed the entire clinical trial and were counted towards the final results. The endpoint was analyzed only for those participants who had data for this outcome measure.||participants|||Number
808922|NCT01039428|Secondary|Number of Participants With Serum Inorganic Phosphorus Reduction of 1.5 mg/dL||baseline and end of the treatment|Full Analysis Set included all randomized participants who received at least one dose of study product. The endpoint was analyzed only for those participants who had data for this outcome measure.||participants|||Number
808923|NCT01039428|Primary|Change in Serum Inorganic Phosphorus at the End of Treatment From Baseline|Change in serum inorganic phosphorus at the end of treatment from baseline|baseline and end of the chewing treatment during three week treatment period|Full Analysis Set included all randomized participants who received at least one dose of study product. The endpoint was analyzed only for those participants who had data for this outcome measure.||mg/dL||Standard Deviation|Mean
808924|NCT01039519|Secondary|Count of Participants With Treatment-Emergent Adverse Events (AEs)|"Treatment-emergent AEs were defined as AEs that occurred from the time of first dose through 30 days after the last dose of study medication. The Investigator graded the severity of AEs according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) criteria:
Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death
A Serious AE is defined as any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or constitutes an important medical event.
Dose modification includes dose delay and dose reduction."|Day 1 up to Week 51|Full analysis set||participants|||Number
808926|NCT01039519|Secondary|Kaplan-Meier Estimate of Overall Survival|Overall survival was defined as the time from first dose to death or the date last known alive.|Day 1 up to week 97|Full analysis set||months||95% Confidence Interval|Median
808927|NCT01039519|Secondary|Kaplan-Meier Estimate of Progression Free Survival (PFS)|"PFS was defined as the time from the baseline CT scan to disease progression per RECIST or death for any cause. Progressive disease (PD) was defined as
at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or
the appearance of 1 or more new lesions or
the unequivocal progression of existing nontarget lesions"|Day 1 up to Week 47|Full analysis set||months||95% Confidence Interval|Median
808928|NCT01039519|Secondary|Percentage of Participants Showing an Objective Response Based on RECIST Version 1.0|"Objective response included participants whose best response with confirmation was a complete response (CR) or partial response (PR) from first dose until progression or end of study.
CR: disappearance of all target lesions and non-target lesions and no new lesions
PR: at least a 30% decrease in the sum of the longest diameter of target lesions, no disease progression for non-target lesions, and no new lesions"|Week 16 up to Week 47|Full analysis set||percentage of participants|||Number
808929|NCT01039519|Primary|Percentage of Participants Showing Clinical Benefit Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0|"Clinical benefit is defined as showing a complete response (CR), a partial response (PR) or stable disease (SD) for at least 16 weeks.
CR: disappearance of all target lesions and non-target lesions and no new lesions
PR: at least a 30% decrease in the sum of the longest diameter of target lesions, no disease progression for non-target lesions, and no new lesions
SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, no disease progression for non-target lesions, and no new lesions"|Week 16 up to Week 47|Full analysis set which included participants receiving at least one dose of study medication.||percentage of participants|||Number
808930|NCT01039584|Secondary|Mycological Cure|Mycological cure was defined as a negative mycological culture (no growth)|Visit 3: Day 22-31|||participants|||Number
808931|NCT01039584|Secondary|Clinical Cure|"Clinical cure (clinical success) was defined as follows:
All signs or symptoms with a score of 1 (mild) or 2 (moderate) at Visit 1/Baseline had a score of 0 (absent) at Visit 3/Test-of-Cure, or all signs or symptoms with a score of 3 (severe) at Visit 1/Baseline had a score of 0 (absent) or 1 (mild) at Visit 3/Test-of-Cure
A new sign or symptoms was observed at Visit 3/Test-of-Cure that was not present at entry and was determined by the investigator to not be related to VVC (if related, the subject was considered a failure; if not related, the subject could have been considered a cure)
The subject did not require additional vulvovaginal or systemic antifungal therapy
The subject did not use any topical drug therapy other than the study medication for the treatment of vulvovaginal irritation and/or pruritus, such as topical analgesics or corticosteroid products"|Visit 3: Day 22-31|per-protocol||participants|||Number
808932|NCT01039584|Primary|The Test of Equivalence Between the Test and Reference Products Was Based on the Therapeutic Cure Rates at Visit 3/Test-of-Cure.|Therapeutic cure is defined as both the mycologically-proven eradication of infection caused by Candida species (mycological cure) and evidence of clinical success (clinical cure)|Visit 3: Day 22-31|per-protocol||participants|||Number
808933|NCT01039675|Secondary|Change From Baseline in Maximum and Minimum Pulse Rate 0 to 6 Hours Post-dose on Days 1, 14, and 28|Pulse rate is defined as the number of heartbeats in a minute (m). A maximum post-Baseline pulse rate was derived as the maximum value recorded at Days 1, 14 and 28. A minimum post-Baseline pulse rate was derived as the minimum value recorded at Days 1, 14 and 28. The maximum and minimum pulse rates were calculated using the 0 to 6 hours (h) post dose measurements on Days 1, 14 and 28, which included pre-dose, and post-dose 15 m, 45 m, 1.5 h, 3 h and 6 h. Maximum and minimum post-Baseline rate were calculated using the nominal 0-6 h post-dose records, and only records collected during the actual 0-7 h post-dose interval were used. Baseline pulse rate is the most recent result taken on or before pre-dose Day 1. Change from Baseline is the maximum or minimum pulse rate minus the Baseline value. Analysis performed using a repeated measures model with covariates of Baseline pulse rate, sex, age, smoking status, treatment and day and day by treatment and day by Baseline interactions.|Baseline, Day 1, Day 14 and Day 28|ITT Population. The overall number of participants presented is the number who provided at least one post-Baseline assessment of 0-6 hours maximum or minimum pulse rate. Those participants who provided data at the indicated time point are represented by n=X, X in the category titles.||Beats per minutes||Standard Error|Least Squares Mean
808934|NCT01039675|Secondary|Change From Baseline in Weighted Mean Pulse Rate Over 0 to 6 Hours Post-dose at Day 1 and Day 14|Pulse rate is defined as the number of heartbeats in a minute. The weighted mean pulse rate was derived by calculating the area under the pulse rate/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. The weighted mean pulse rate was calculated using the 0 to 6 hours post dose measurements on Day 1 and Day 14, which included pre-dose, and post-dose 15 minutes, 45 minutes, 1.5 hours, 3 hours and 6 hours. Baseline pulse rate is the most recent result taken on or before pre-dose Day 1. Change from Baseline is the weighted mean pulse rate at Day 1 or Day 14 minus the Baseline value. Analysis was performed using a repeated measures model with covariates of Baseline pulse rate, sex, age, smoking status, treatment and day and day by treatment and day by Baseline interactions.|Baseline, Day 1, and Day 14|ITT Population. All participants with >=1 post-BL assessment are included in the analysis. Different participants may have been analyzed at different time points (represented by n=X, X in the category titles), so the overall number of participants analyzed reflects everyone in the ITT Population with data avaialable at >=1 time point.||Beats per minutes||Standard Error|Least Squares Mean
808935|NCT01039675|Primary|Change From Baseline in Weighted Mean Pulse Rate Over 0 to 6 Hours Post-dose at Day 28|Pulse rate is defined as the number of heartbeats in a minute. The weighted mean pulse rate was derived by calculating the area under the pulse rate/time curve (AUC), and then dividing the value by the time interval over which the AUC was calculated. The weighted mean pulse rate was calculated using the 0 to 6 hours post dose measurements at Day 28, which included pre-dose, and post-dose 15 minutes, 45 minutes, 1.5 hours, 3 hours and 6 hours. Baseline pulse rate is the most recent result taken on or before pre-dose Day 1. Change from Baseline is the weighted mean pulse rate at Day 28 minus the Baseline value. Analysis was performed using a repeated measures model with covariates of Baseline pulse rate, sex, age, smoking status, treatment and day and day by treatment and day by Baseline interactions.|Baseline and Day 28|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received >= 1 dose of randomized study medication. All participants with >=1 post-BL assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 28.||Beats per minutes (bpm)||Standard Error|Least Squares Mean
808936|NCT01039792|Primary|Clinical Global Impression-Improvement (CGI-I)|PI assesses subject's change using the CGI-I measure. This is a 7-point Likert scale that assesses improvement of the patient's condition. Scores range from the worst score of 7 (Very much worse) to the best score of 1 (Very much improved). Lower scores are better on this scale, and indicate greater improvement.|8 weeks|comparing placebo vs active B12 subjects||CGI- Improvement||Standard Deviation|Mean
808937|NCT01040052|Primary|Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine|Solicited injection site reactions: Pain, itchiness, erythema (redness), and swelling. Solicited systemic reactions: Headache, body ache and muscle weakness, tiredness, chill, nausea, vomiting, rash, itchiness, anorexia, sore and swollen joints, diarrhea, lymph node swelling, and fever (temperature).|Days 0-7 Post-vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.||Participants|||Number
808938|NCT01040130|Secondary|Number of Patients With Notable Increase in QRS Intervals|Number of Patients with notable increase in QRS intervals. Notable QRS interval increase defined as >=10% increase and on-treatment QRS interval > 110 ms.|Baseline and Week 6|Treated set.||percentage of participants|||Number
808939|NCT01040130|Secondary|Number of Patients With Notable Increase in PR Intervals|Number of Patients with notable increase in PR intervals. Notable PR interval increase defined as >=25% increase and on-treatment PR interval > 200 ms.|Baseline and Week 6|Treated set.||percentage of participants|||Number
808940|NCT01040130|Secondary|Number of Patients With Notable Changes in Heart Rate|Number of Patients with notable changes in heart rate (HR). Notable HR increase defined as >=25% increase and on-treatment HR > 100 bpm; Notable HR decrease defined as >=25% decrease and on-treatment HR < 50 bpm.|Baseline and Week 6|Treated set.||percentage of participants|||Number
808941|NCT01040130|Secondary|Change From Baseline to Day 43 in Pulse Rate|Change from Baseline to Day 43 in Pulse rate with spirometry. Baseline is defined as mean of pre-treatment values at a given time point.|Baseline and Week 6|Treated set. Statistics only include patients with both a baseline and a post dose value.||beats/min||Standard Deviation|Mean
808942|NCT01040130|Secondary|Change From Baseline to Day 43 in Blood Pressure|Change from Baseline to Day 43 in Blood Pressure with spirometry. Baseline is defined as mean of pre-treatment values at a given time point.|Baseline and Week 6|Treated set. Statistics only include patients with both a baseline and a post dose value.||mmHg||Standard Deviation|Mean
808943|NCT01040130|Secondary|Adjusted Mean Peak Expiratory Flow Rate, 1 Hour Post-dose After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.||liters/second||Standard Error|Least Squares Mean
808944|NCT01040130|Secondary|Adjusted Mean Peak Expiratory Flow Rate, 30 Minutes Pre-dose After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.||liters/second||Standard Error|Least Squares Mean
808945|NCT01040130|Secondary|Adjusted Mean Forced Vital Capacity, 1 Hour Post-dose After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.||liters||Standard Error|Least Squares Mean
808946|NCT01040130|Secondary|Adjusted Mean Forced Vital Capacity, 30 Minutes Pre-dose After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.||liters||Standard Error|Least Squares Mean
808947|NCT01040130|Secondary|Adjusted Mean Forced Expiratory Volume in 1 Second, 1 Hour Post-dose After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.||liters||Standard Error|Least Squares Mean
808948|NCT01040130|Secondary|Adjusted Mean Forced Expiratory Volume in 1 Second, 30 Minutes Pre-dose After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.||liters||Standard Error|Least Squares Mean
808949|NCT01040130|Secondary|Adjusted Mean Total Lung Capacity 1 Hour Post-dose After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.||liters||Standard Error|Least Squares Mean
808950|NCT01040130|Secondary|Adjusted Mean Total Lung Capacity 30 Minutes Pre-dose After 6 Weeks|Measured using body plethysmography|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.||liters||Standard Error|Least Squares Mean
808951|NCT01040130|Secondary|Adjusted Mean Inspiratory Capacity 1 Hour Post-dose After 6 Weeks|Measured using body plethysmography|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.||liters||Standard Error|Least Squares Mean
808952|NCT01040130|Secondary|Adjusted Mean Inspiratory Capacity 30 Minutes Pre-dose After 6 Weeks|Measured using body plethysmography|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.||liters||Standard Error|Least Squares Mean
808968|NCT01040260|Primary|Abstinence From Tobacco Use||52 weeks||||||
808953|NCT01040130|Secondary|Adjusted Mean Functional Residual Capacity 1 Hour Post-dose After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.||liters||Standard Error|Least Squares Mean
808954|NCT01040130|Secondary|Adjusted Mean Functional Residual Capacity 30 Minutes Pre-dose After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.||liters||Standard Error|Least Squares Mean
808955|NCT01040130|Secondary|Adjusted Mean Borg Scale of Breathing Discomfort at End of Exercise After 6 Weeks|Borg scale rates discomfort with breathing at rest, during exercise and at end-exercise on a scale from 0=Nothing at all to 10=Maximal discomfort.|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint.||Scores on a scale||Standard Error|Least Squares Mean
808956|NCT01040130|Secondary|Adjusted Mean Borg Scale of Breathing Discomfort at Pre-exercise After 6 Weeks|Borg scale rates discomfort with breathing at rest, during exercise and at end-exercise on a scale from 0=Nothing at all to 10=Maximal discomfort.|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.||Scores on a scale||Standard Error|Least Squares Mean
808957|NCT01040130|Secondary|Adjusted Mean Inspiratory Capacity at End of Exercise After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.||liters||Standard Error|Least Squares Mean
808958|NCT01040130|Secondary|Adjusted Mean Inspiratory Capacity at Pre-exercise After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.||liters||Standard Error|Least Squares Mean
808959|NCT01040130|Secondary|Adjusted Mean Borg Scale of Breathing Discomfort at Isotime After 6 Weeks|"Isotime is defined as the endurance time of the constant work rate exercise test of shortest duration from Baseline visit, and Week 6 of each of the three treatment periods.
Borg scale rates discomfort with breathing at rest, during exercise and at end-exercise on a scale from 0=Nothing at all to 10=Maximal discomfort."|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint.||Scores on a scale||Standard Error|Least Squares Mean
808960|NCT01040130|Secondary|Adjusted Mean Inspiratory Capacity at Isotime After 6 Weeks|Isotime is defined as the endurance time of the constant work rate exercise test of shortest duration from Baseline visit, and Week 6 of each of the three treatment periods.|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.||liters||Standard Error|Least Squares Mean
808961|NCT01040130|Primary|Adjusted Mean Endurance Time After 6 Weeks|Primary endpoint was endurance time during constant work rate ergometry to symptom limitation at 75% of maximal work capacity after 6 weeks of treatment. Mixed effects model on log10 transformation data. Adjusted means are back transformed to report as geometric means. Standard errors (SEs) are calculated using the delta method.|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint.||seconds||Standard Error|Geometric Mean
808962|NCT01040169|Primary|Tooth Hypersensivity Stimuli to Air|Units on a scale using Schiff Cold Air Sensitivity Scale. Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth. According to this analog scale hypersensitivity scores for the stimulated tooth is 0, 1, 2 or 3(The lower the score, the lower the hypersensitivity). 0=No subject response to stimulus, 1=responds but will continue, 2=responds and moves or requests discontinuation, 3=Painful response to stimulus, discontinuation requested.|12 weeks (Final)|||Units on a scale||Standard Deviation|Mean
808963|NCT01040169|Primary|Tooth Hypersensitity to Touch Stimuli (Tactile)|Units on a scale:Measured with an electronic force sensing probe(Yeaple Probe):10, 20, 30, 40,up to 50 grams of force are applied to hypersensitive tooth until pain is felt. This calibrated instrument measures grams of force applied to each tooth before pain is felt. This data is recorded as the hypersensitivity score. The lower the score, the higher the hypersensitivity.Changes in this score to potentially painful stimulus are determined based on how many grams of force can be applied before the subject reports feeling pain. Grams of force is therefore the unit measurement for sensitivity|12 weeks (Final)|||Units on a scale||Standard Deviation|Mean
808964|NCT01040208|Secondary|The Occurrence of Mild Anxiety Symptoms (i.e., a Total Score of '8' to '16', Inclusive) That Have Remitted (i.e., a Total Score of '7' or Less) on the Beck Anxiety Inventory at Visit 6 (Week 12)||12 weeks|The treated set (TS) consisted of those patients who were dispensed study medication and who were documented to have taken at least one dose of study medication. All analyses were conducted on the TS.||participants|||Number
808965|NCT01040208|Secondary|The Occurrence of Mild Depressive Symptoms (i.e., a Total Score of '7' to '11', Inclusive) That Have Remitted (i.e., a Total Score of '6' or Less) on the 16 Item Quick Inventory of Depressive Symptoms - Self Report at Visit 6 (Week 12)||12 weeks|The treated set (TS) consisted of those patients who were dispensed study medication and who were documented to have taken at least one dose of study medication. All analyses were conducted on the TS.||participants|||Number
808966|NCT01040208|Primary|The Primary Safety Endpoint is the Occurrence of Adverse Events During the Treatment and Post Treatment Period.||17 weeks|The treated set (TS) consisted of those patients who were dispensed study medication and who were documented to have taken at least one dose of study medication. All analyses were conducted on the TS.||participants|||Number
808967|NCT01040260|Primary|Abstinence Rate|Verified 7-Day Point-prevalence abstinence rate|52 weeks|||participants|||Number
808969|NCT01028820|Primary|Baseline and Week 8scores on Children's Yale-Brown Obsessive Compulsive Scale - Pervasive Developmental Disorder Version|The Children's Yale-Brown Obsessive Compulsive Scale - Pervasive Developmental Disorder Version (CY-BOCS-PDD) is a clinician-rated interview designed to evaluate repetitive behavior in children with pervasive developmental disorders (PDDs). It is a modification of the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS), developed to assess typically-developing children with obsessive compulsive behavior. Because of language limitations in children with PDDs the CY-BOCS—PDD only includes the five compulsion items: Time Spent, Interference, Distress, Resistance of repetitive behavior, and Control of repetitive behavior. Each item is rated from 0 (none) through 4 (extreme), and scores can range from 0 to 20, with higher scores reflecting more severe symptoms. Usually a score > than 8 is considered clinically significant.|"Baseline (Pre-Dose) to 8 Weeks (Post-Dose)"|All randomized participants' scores were analyzed using the PDD-CYBOCS measure. Higher values reflect worse outcomes. Subscales are added to compute the total score (total score does not include compulsion free-interval and peculiarity of the behavior.||Scores on a scale||Standard Deviation|Mean
808970|NCT01028820|Secondary|Total Repetitive Behavior Scale - Revised (RBS_R)|"The RBS-R is an assessment that includes Sameness, Self-Injurious Behavior, Ritualistic, Compulsive, and Restrictive Behavior subscales. The assessments are completed by caregivers for the past week, with consideration of frequency,ease of redirecting and extent to which behavior interferes with functioning compared to a typically developing child of the same age and gender. Scores are rated from 0 - behavior does not occur to 3 - behavior occurs and is a serious problem. There are 43 items and 5 subscales. Higher scores indicate greater symptom severity. total score is the sum of all items in all subscales.
The subscales are stereotyped behaviors 6 items, self-injurious behaviors 8 items, Compulsive behaviors- 8 items, Ritualistic Behaviors 6 items, Sameness 11 items, restricted behaviors 4 items.Total score ranges from 0 to 129."|baseline week 0, 8 weeks|All randomized participants' scores were analyzed using the RBS-R measure. Higher values reflect worse outcomes (greater symptom severity). Subscales are added to compute the total score.||units on a scale||Standard Deviation|Mean
808971|NCT01028911|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) for Donepezil||0 hour (pre-dose), 0.5, 1, 3, 8, 12 hours post-dose on Day 0, Day 30|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest during the study.||hours||Full Range|Median
808972|NCT01028911|Secondary|Maximum Plasma Concentration (Cmax) for Donepezil||0 hour (pre-dose), 0.5, 1, 3, 8, 12 hours post-dose on Day 0, Day 30|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest during the study.||ng/mL||Standard Deviation|Geometric Mean
808973|NCT01028911|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Donepezil||0 hour (pre-dose), 0.5, 1, 3, 8, 12 hours post-dose on Day 0, Day 30|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest during the study.||ng*hr/mL||Standard Deviation|Geometric Mean
808974|NCT01028911|Secondary|Time to Reach Maximum Observed Serum Concentration (Tmax) for PF-03654746||0 hour (pre-dose), 0.5, 1, 3, 8 and 12 hours post-dose on Day 30|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest during the study.||hours||Full Range|Median
808975|NCT01028911|Secondary|Maximum Serum Concentration (Cmax) for PF-03654746||0 hour (pre-dose), 0.5, 1, 3, 8 and 12 hours post-dose on Day 30|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest during the study.||nanogran per millileter (ng/mL)||Standard Deviation|Geometric Mean
808976|NCT01028911|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for PF-03654746||0 hour (pre-dose), 0.5, 1, 3, 8 and 12 hours post-dose on Day 30|Pharmacokinetic (PK) parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest during the study.||nanogram hour per milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
808977|NCT01028911|Primary|Change From Baseline in Mini Mental State Examination (MMSE) Total Score at Follow-up|MMSE measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. Total score derived from sub-scores; total ranged from 0 to 30, higher score indicates better cognitive state.|Baseline, Follow-up (7 to 10 days after last dose)|Safety population included all participants who took at least 1 dose of study drug.||units on a scale||Standard Deviation|Mean
808978|NCT01028911|Primary|Change From Baseline in Mini Mental State Examination (MMSE) Total Score at Day 30|MMSE measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. Total score derived from sub-scores; total ranged from 0 to 30, higher score indicates better cognitive state.|Baseline, Day 30|Safety population included all participants who took at least 1 dose of study drug.||units on a scale||Standard Deviation|Mean
808979|NCT01028911|Primary|Change From Baseline in Mini Mental State Examination (MMSE) Total Score at Day 25|MMSE measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. Total score derived from sub-scores; total ranged from 0 to 30, higher score indicates better cognitive state.|Baseline, Day 25|Safety population included all participants who took at least 1 dose of study drug.||units on a scale||Standard Deviation|Mean
808980|NCT01028911|Primary|Change From Baseline in Mini Mental State Examination (MMSE) Total Score at Day 20|MMSE measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. Total score derived from sub-scores; total ranged from 0 to 30, higher score indicates better cognitive state.|Baseline, Day 20|Safety population included all participants who took at least 1 dose of study drug.||units on a scale||Standard Deviation|Mean
808981|NCT01028911|Primary|Change From Baseline in Mini Mental State Examination (MMSE) Total Score at Day 15|MMSE measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. Total score derived from sub-scores; total ranged from 0 to 30, higher score indicates better cognitive state.|Baseline, Day 15|Safety population included all participants who took at least 1 dose of study drug.||units on a scale||Standard Deviation|Mean
808982|NCT01028911|Primary|Change From Baseline in Mini Mental State Examination (MMSE) Total Score at Day 10|MMSE measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. Total score derived from sub-scores; total ranged from 0 to 30, higher score indicates better cognitive state.|Baseline, Day 10|Safety population included all participants who took at least 1 dose of study drug.||units on a scale||Standard Deviation|Mean
808983|NCT01028911|Primary|Change From Baseline in Mini Mental State Examination (MMSE) Total Score at Day 5|MMSE measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. Total score derived from sub-scores; total ranged from 0 to 30, higher score indicates better cognitive state.|Baseline, Day 5|Safety population included all participants who took at least 1 dose of study drug.||units on a scale||Standard Deviation|Mean
808984|NCT01028911|Primary|Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score at Follow-up|NPI: 12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, night-time behavior. Severity (1=Mild to 3=Severe), frequency (1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score (range 0-12). Total score=sum of each domain score (range 0-144); higher score=greater behavioral disturbances; negative change score from baseline=improvement.|Baseline, Follow-up (7 to 10 days after last dose)|Safety population included all participants who took at least 1 dose of study drug.||units on a scale||Standard Deviation|Mean
808985|NCT01028911|Primary|Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score at Day 30|NPI: 12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, night-time behavior. Severity (1=Mild to 3=Severe), frequency (1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score (range 0-12). Total score=sum of each domain score (range 0-144); higher score=greater behavioral disturbances; negative change score from baseline=improvement.|Baseline, Day 30|Safety population included all participants who took at least 1 dose of study drug.||units on a scale||Standard Deviation|Mean
808986|NCT01028911|Primary|Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score at Day 25|NPI: 12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, night-time behavior. Severity (1=Mild to 3=Severe), frequency (1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score (range 0-12). Total score=sum of each domain score (range 0-144); higher score=greater behavioral disturbances; negative change score from baseline=improvement.|Baseline, Day 25|Safety population included all participants who took at least 1 dose of study drug.||units on a scale||Standard Deviation|Mean
808987|NCT01028911|Primary|Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score at Day 20|NPI: 12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, night-time behavior. Severity (1=Mild to 3=Severe), frequency (1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score (range 0-12). Total score=sum of each domain score (range 0-144); higher score=greater behavioral disturbances; negative change score from baseline=improvement.|Baseline, Day 20|Safety population included all participants who took at least 1 dose of study drug.||units on a scale||Standard Deviation|Mean
808988|NCT01028911|Primary|Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score at Day 15|NPI: 12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, night-time behavior. Severity (1=Mild to 3=Severe), frequency (1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score (range 0-12). Total score=sum of each domain score (range 0-144); higher score=greater behavioral disturbances; negative change score from baseline=improvement.|Baseline, Day 15|Safety population included all participants who took at least 1 dose of study drug.||units on a scale||Standard Deviation|Mean
808989|NCT01028911|Primary|Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score at Day 10|NPI: 12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, night-time behavior. Severity (1=Mild to 3=Severe), frequency (1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score (range 0-12). Total score=sum of each domain score (range 0-144); higher score=greater behavioral disturbances; negative change score from baseline=improvement.|Baseline, Day 10|Safety population included all participants who took at least 1 dose of study drug.||units on a scale||Standard Deviation|Mean
808990|NCT01028911|Primary|Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score at Day 5|NPI: 12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, night-time behavior. Severity (1=Mild to 3=Severe), frequency (1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score (range 0-12). Total score=sum of each domain score (range 0-144); higher score=greater behavioral disturbances; negative change score from baseline=improvement.|Baseline, Day 5|Safety population included all participants who took at least 1 dose of study drug.||units on a scale||Standard Deviation|Mean
809044|NCT01029340|Secondary|Part B - Changes From Baseline at 12 Months in Utility Index as Measured by EQ–5D Questionaire|A measure of how treatment with BAY81-8973 affected the daily life of participants. 1.0 = Best possible score, -0.594 = Worst possible score. Positive changes from baseline indicate an improvement and negative changes indicate a deterioration.|Baseline and 12 months|ITT. Note: Only 61 of the 62 participants had data available for the Utility Index of the EQ-5D questionnaire at Month 12.||Scores on a scale||Full Range|Median
808991|NCT01028911|Primary|Medical Outcomes Study - Sleep Scale (MOS-SS) Score at Follow-up|Participant-rated 12-item questionnaire to assess sleep quality and quantity. The items contribute to each scale and are averaged to create the 7 subscale scores: sleep disturbance, snoring, awaken short of breath (ASoB) or with a headache, somnolence, sleep adequacy, sleep quantity (range 0 to 24) and optimal sleep (yes: 1, no: 0), and overall sleep problem index (SPI) I and II. Except for sleep quantity and optimal sleep, scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute. Except for sleep quantity, sleep adequacy and optimal sleep, higher scores=greater impairment. Scales with at least one item answered was used to generate a scale score.|Follow-up (7 to 10 days after last dose)|Safety population included all participants who took at least 1 dose of study drug.||units on a scale||Standard Deviation|Mean
808992|NCT01028911|Primary|Medical Outcomes Study - Sleep Scale (MOS-SS) Score at Day 30|Participant-rated 12-item questionnaire to assess sleep quality and quantity. The items contribute to each scale and are averaged to create the 7 subscale scores: sleep disturbance, snoring, awaken short of breath (ASoB) or with a headache, somnolence, sleep adequacy, sleep quantity (range 0 to 24) and optimal sleep (yes: 1, no: 0), and overall sleep problem index (SPI) I and II. Except for sleep quantity and optimal sleep, scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute. Except for sleep quantity, sleep adequacy and optimal sleep, higher scores=greater impairment. Scales with at least one item answered was used to generate a scale score.|Day 30|Safety population included all participants who took at least 1 dose of study drug.||units on a scale||Standard Deviation|Mean
808993|NCT01028911|Primary|Medical Outcomes Study - Sleep Scale (MOS-SS) Score at Day 25|Participant-rated 12-item questionnaire to assess sleep quality and quantity. The items contribute to each scale and are averaged to create the 7 subscale scores: sleep disturbance, snoring, awaken short of breath (ASoB) or with a headache, somnolence, sleep adequacy, sleep quantity (range 0 to 24) and optimal sleep (yes: 1, no: 0), and overall sleep problem index (SPI) I and II. Except for sleep quantity and optimal sleep, scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute. Except for sleep quantity, sleep adequacy and optimal sleep, higher scores=greater impairment. Scales with at least one item answered was used to generate a scale score.|Day 25|Safety population included all participants who took at least 1 dose of study drug.||units on a scale||Standard Deviation|Mean
808994|NCT01028911|Primary|Medical Outcomes Study - Sleep Scale (MOS-SS) Score at Day 20|Participant-rated 12-item questionnaire to assess sleep quality and quantity. The items contribute to each scale and are averaged to create the 7 subscale scores: sleep disturbance, snoring, awaken short of breath (ASoB) or with a headache, somnolence, sleep adequacy, sleep quantity (range 0 to 24) and optimal sleep (yes: 1, no: 0), and overall sleep problem index (SPI) I and II. Except for sleep quantity and optimal sleep, scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute. Except for sleep quantity, sleep adequacy and optimal sleep, higher scores=greater impairment. Scales with at least one item answered was used to generate a scale score.|Day 20|Safety population included all participants who took at least 1 dose of study drug.||units on a scale||Standard Deviation|Mean
808995|NCT01028911|Primary|Medical Outcomes Study - Sleep Scale (MOS-SS) Score at Day 15|Participant-rated 12-item questionnaire to assess sleep quality and quantity. The items contribute to each scale and are averaged to create the 7 subscale scores: sleep disturbance, snoring, awaken short of breath (ASoB) or with a headache, somnolence, sleep adequacy, sleep quantity (range 0 to 24) and optimal sleep (yes: 1, no: 0), and overall sleep problem index (SPI) I and II. Except for sleep quantity and optimal sleep, scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute. Except for sleep quantity, sleep adequacy and optimal sleep, higher scores=greater impairment. Scales with at least one item answered was used to generate a scale score.|Day 15|Safety population included all participants who took at least 1 dose of study drug.||units on a scale||Standard Deviation|Mean
808996|NCT01028911|Primary|Medical Outcomes Study - Sleep Scale (MOS-SS) Score at Day 10|Participant-rated 12-item questionnaire to assess sleep quality and quantity. The items contribute to each scale and are averaged to create the 7 subscale scores: sleep disturbance, snoring, awaken short of breath (ASoB) or with a headache, somnolence, sleep adequacy, sleep quantity (range 0 to 24) and optimal sleep (yes: 1, no: 0), and overall sleep problem index (SPI) I and II. Except for sleep quantity and optimal sleep, scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute. Except for sleep quantity, sleep adequacy and optimal sleep, higher scores=greater impairment. Scales with at least one item answered was used to generate a scale score.|Day 10|Safety population included all participants who took at least 1 dose of study drug.||units on a scale||Standard Deviation|Mean
808997|NCT01028911|Primary|Medical Outcomes Study - Sleep Scale (MOS-SS) Score at Day 5|Participant-rated 12-item questionnaire to assess sleep quality and quantity. The items contribute to each scale and are averaged to create the 7 subscale scores: sleep disturbance, snoring, awaken short of breath (ASoB) or with a headache, somnolence, sleep adequacy, sleep quantity (range 0 to 24) and optimal sleep (yes: 1, no: 0), and overall sleep problem index (SPI) I and II. Except for sleep quantity and optimal sleep, scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute. Except for sleep quantity, sleep adequacy and optimal sleep, higher scores=greater impairment. Scales with at least one item answered was used to generate a scale score.|Day 5|Safety population included all participants who took at least 1 dose of study drug.||units on a scale||Standard Deviation|Mean
809045|NCT01029340|Secondary|Part B - Changes From Baseline at 12 Months in Quality of Life (QoL) as Measured by Transformed Total Score of Haemo-QoL Questionnaire|A measure of how treatment with BAY81-8973 affected the daily life of participants. the scoring system has 100 points. 0 is the worst possible score. 100 is the best possible score. Positive changes from baseline indicate an improvement in quality of life and negative changes indicate a deterioration.|Baseline and 12 months|ITT. Note: Only 51 of the 62 participants had data available for the 12-month QoL analysis.||Scores on a scale||Full Range|Median
808998|NCT01028911|Primary|Medical Outcomes Study - Sleep Scale (MOS-SS) Score at Baseline|Participant-rated 12-item questionnaire to assess sleep quality and quantity. The items contribute to each scale and are averaged to create the 7 subscale scores: sleep disturbance, snoring, awaken short of breath (ASoB) or with a headache, somnolence, sleep adequacy, sleep quantity (range 0 to 24) and optimal sleep (yes: 1, no: 0), and overall sleep problem index (SPI) I and II. Except for sleep quantity and optimal sleep, scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute. Except for sleep quantity, sleep adequacy and optimal sleep, higher scores=greater impairment. Scales with at least one item answered was used to generate a scale score.|Baseline|Safety population included all participants who took at least 1 dose of study drug.||units on a scale||Standard Deviation|Mean
808999|NCT01028911|Primary|Number of Participants With Clinically Significant Change From Baseline in Physical Examination|Physical examination included examination of the skin, eyes, ears, throat, neck, and cardiac, respiratory, gastrointestinal and musculoskeletal systems. The examination assessed the participants for any potential changes in physical status, as determined by the investigator. Any untoward findings identified on physical exams conducted after the administration of the first dose of study medication was captured as an adverse event.|Baseline up to 7 to 10 days after last dose|Safety population included all participants who took at least 1 dose of study drug.||participants|||Number
809000|NCT01028911|Primary|Number of Participants With Clinically Significant Laboratory Test Abnormalities|Criteria for laboratory tests abnormalities included: hemoglobin, hematocrit and red blood cells (< 0.8*lower limit of normal[LLN]); leucocytes (<0.6/>1.5*upper limit of normal [ULN]); platelets (<0.5*LLN/>1.75*ULN); neutrophils, lymphocytes (<0.8*LLN/>1.2*ULN); eosinophils, basophils, monocytes (>1.2*ULN); total bilirubin (>1.5*ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (>3*ULN), total protein, albumin (<0.8*LLN/>1.2*ULN); creatinine, urea (>1.3*ULN); glucose (<0.6*LLN/>1.5*ULN); uric acid (>1.2*ULN); sodium, potassium, chloride, calcium, bicarbonate (<0.9*LLN/>1.1*ULN); urine red blood cells (RBCs), urine white blood cells (WBCs), urine epithelial cells (>=6 high-powered field), urine bacteria >20 high-powered field; qualitative urine glucose, ketones, protein values >=1 in urine dipstick test. Total number of participants with any laboratory abnormalities was reported.|Baseline up to 7 to 10 days after last dose|Safety population included all participants who took at least 1 dose of study drug.||participants|||Number
809001|NCT01028911|Primary|Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities|Criteria for potential clinical concern in ECG parameters: maximum PR interval of >=300 milliseconds (msec), maximum QRS interval >=200 msec, maximum fridericia’s corrected QT (QTcF) interval >=500 msec, PR interval or QRS interval increase from baseline >=25 percent (%) or 50 percent (%), QTCF interval increase from baseline 30 to 60 msec or >=60 msec.|Baseline up to 7 to 10 days after last dose|Safety population included all participants who took at least 1 dose of study drug.||participants|||Number
809002|NCT01028911|Primary|Number of Participants With Clinically Significant Vital Sign Abnormalities|Criteria for potential clinical concern in vital signs: supine and standing systolic blood pressure (SBP) less than (<) 90 millimeter of mercury (mmHg), supine and standing diastolic BP (DBP) <50 mmHg, supine pulse rate <40 beats per minute (bpm) or >120 bpm, standing pulse rate <40 bpm or >140 bpm. Maximum increase or decrease from baseline in supine (Su) and standing (St) SBP >=30 mmHg and maximum increase or decrease from baseline in supine and standing DBP >=20 mmHg.|Baseline up to 7 to 10 days after last dose|Safety population included all participants who took at least 1 dose of study drug.||participants|||Number
809003|NCT01029054|Primary|The Percentage of Patients That Achieve a Response to Treatment|"The percentage of patients that achieve at least a sCR (Stringent Complete Response), at least a VGPR (Very Good Partial Response) and at least a PR (Partial Response) will be determined.
sCR is defined as:
Negative immunofixation on the serum and urine and
Disappearance of any soft tissue plasmacytomas and
< 5% plasma cells in bone marrow and
Normal SFLC ratio and
Absence of clonal cells in bone marrow
VGPR is defined as:
Serum and urine M-protein detectable by immunofixation but not on electrophoresis or
≥ 90% reduction in serum M-component with urine M-component < 100 mg per 24 hours
PR is defined as:
≥ 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥ 90% or to < 200 mg per 24 hours
If present at baseline, a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required"|4 Months After Treatment Start|||percentage of patients|||Number
809004|NCT01029054|Secondary|The Percentage of Patients Alive Without Progression|"The Progression Free Survival (PFS) rate will be determined at 12 and 24 months post treatment.
Progressive Disease (PD) is defined as an increase of greater than or equal to 25% from lowest response level in serum M-component and/ or urine M-component and/ or the difference between involved or uninvolved SFLC levels and/ or bone marrow % plasma cells. PD may also be the development of new bone lesions or soft tissue plasmacytomas or the increase in size of existing lesions. PD may also be the development of hypercalcemia."|12 Months and 24 Months Post Treatment|||percentage of patients|||Number
809005|NCT01029054|Primary|The Maximum Tolerated Dose (MTD) of Carfilzomib|Determine the MTD of Carfilzomib when combined with Lenalidomide and Dexamethasone. The estimated time to determine the MTD is 6 months.|6 Months|Of the 53 patients enrolled, 35 were entered into the Phase I portion of the study.||mg/m^2|||Number
809006|NCT01029262|Secondary|Healthcare Resource Utilization (HRU): Rate of Inpatient Hospitalizations, Concomitant Procedures/Surgeries and the Differences Between Treatment Arms|HRU was defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient. HRU Analysis may help in evaluating potential costs and budget impact of new treatments from a payer perspective.|Up to 5 years||05/2017||||
809046|NCT01029340|Secondary|Part B - Control of Bleeding as Measured by the Number of Injections Required to Treat a Bleed|The number of injections needed by participants to stop a bleed|6 months on each potency|ITT. Note: One participant in Part B did not receive any Recombinant Factor VIII measured by the CS/ADJ method, leading to 61 participants (not 62) in that group.||Injections|Participants|Full Range|Median
809047|NCT01029340|Secondary|Part B - Annualized Number of Bleeds in Each 6-month Potency Assignment Period|The annualized number of bleeds experienced by participants in each of the two treatment periods|6 months on each potency|ITT. Note: One participant in Part B did not receive any Recombinant Factor VIII measured by the CS/ADJ method, leading to 61 participants (not 62) in that group.||Bleeds||Inter-Quartile Range|Median
822945|NCT01165983|Secondary|Absolute Change in Biochemical Markers of Endothelial Function, sICAM-1, ng/mL||12 Weeks post-randomization|||ng/mL||Inter-Quartile Range|Median
809007|NCT01029262|Secondary|Percentage of Participants With a Clinically Meaningful Improvement in HRQOL Associated With the EORTC QLQ-C-30 Scale From Baseline in the Emotional Functioning Domain at Weeks 12 and 24|"The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).
The EORTC QLQ-C30 Emotional Functioning Domain was scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement."|Baseline, Week 12, ±3 days and Week 24, ±3 days|"Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point (indicated by n ) are included."||percentage of participants|||Number
809008|NCT01029262|Secondary|Percentage of Participants With a Clinically Meaningful Improvement in HRQOL Associated With the EORTC QLQ-C-30 Scale From Baseline in the Global Health Status/QOL Domain at Weeks 12 and 24|The European Organization for Research and Treatment of Cancer QOL Questionnaire for Patients with Cancer (EORTC QLQ-C30) was a 30-item oncology-specific questionnaire. The questionnaire was developed to assess the quality of life of cancer patients. It contains 30 questions, 24 of which form 9 multi-item scales representing various aspects of HRQOL: 1 global scale, 5 functional scales (Physical, Role, Emotional, Cognitive and Social), and 3 symptom scales (Fatigue, Pain, and Nausea). The remaining 6 items are intended to be mono-item scales describing relevant cancer-oriented symptoms (dyspnea, insomnia, appetite, constipation, diarrhea, financial difficulties). Subscale scores are transformed to a 0 to 100 scale, with higher scores on functional scales indicating better function and higher score on symptom scales indicating worse symptoms. A change of at least 10 points on the standardized domain scores was required for it to be considered clinically meaningful.|Baseline, Week 12, ±3 days and Week 24, ±3 days|"Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment with the EORTC QLQ-C-30. Only those with available data at baseline and each time point (indicated by n) are included."||percentage of participants|||Number
809009|NCT01029262|Secondary|Percentage of Participants With a Clinically Meaningful Improvement in HRQOL Associated With the EORTC QLQ-C-30 Scale From Baseline Within the Physical Functioning Domain at Weeks 12 and 24|The European Organization for Research and Treatment of Cancer QOL Questionnaire for Patients with Cancer (EORTC QLQ-C30) was a 30-item oncology-specific questionnaire. The questionnaire was developed to assess the quality of life of cancer patients. It contains 30 questions, 24 of which form 9 multi-item scales representing various aspects of HRQOL: 1 global scale, 5 functional scales (Physical, Role, Emotional, Cognitive and Social), and 3 symptom scales (Fatigue, Pain, and Nausea). The remaining 6 items are intended to be mono-item scales describing relevant cancer-oriented symptoms (dyspnea, insomnia, appetite, constipation, diarrhea, financial difficulties). Subscale scores are transformed to a 0 to 100 scale, with higher scores on functional scales indicating better function and higher score on symptom scales indicating worse symptoms. A change of at least 10 points on the standardized domain scores was required for it to be considered clinically meaningful.|Baseline, Week 12, ±3 days and Week 24, ±3 days|"Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment with the EORTC QLQ-C-30. Only those with available data at baseline and each time point (indicated by n) are included."||percentage of participants|||Number
809010|NCT01029262|Secondary|Percentage of Participants With a Clinically Meaningful Improvement in HRQOL Associated With the EORTC QLQ-C-30 Scale From Baseline in the Dyspnea Domain at Weeks 12 and 24|"The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).
The EORTC QLQ-C30 Dyspnea scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate decreased dyspnea (i.e. improvement in symptom) and positive values indicate increased dyspnea (i.e. worsening of symptom). Improvement means at least 10 points better compared to baseline."|Baseline, Week 12, ±3 days and Week 24, ±3 days|"Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point (indicated by n) are included."||percentage of participants|||Number
809011|NCT01029262|Secondary|Percentage of Participants With a Clinically Meaningful Improvement in QOL (EORTC QLQ-C-30 Scale) From Baseline in Fatigue Domain at Weeks 12 and 24|The European Organization for Research and Treatment of Cancer QOL Questionnaire for Patients with Cancer (EORTC QLQ-C30) was a 30-item oncology-specific questionnaire. The questionnaire was developed to assess the quality of life of cancer patients. It contains 30 questions, 24 of which form 9 multi-item scales representing various aspects of HRQOL: 1 global scale, 5 functional scales (Physical, Role, Emotional, Cognitive and Social), and 3 symptom scales (Fatigue, Pain, and Nausea). The remaining 6 items are intended to be mono-item scales describing relevant cancer-oriented symptoms (dyspnea, insomnia, appetite, constipation, diarrhea, financial difficulties). Subscale scores are transformed to a 0 to 100 scale, with higher scores on functional scales indicating better function and higher score on symptom scales indicating worse symptoms. Improvement means at least 10 points better compared to baseline|Baseline, Week 12, ±3 days and Week 24, ±3 days|"Analyses were performed based on the Health Related Quality of Life (HRQoL) evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point (indicated by n ) are included."||percentage of participants|||Number
809908|NCT01047553|Primary|ECG Variables RR Interval|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.||milisecond||Standard Deviation|Mean
809012|NCT01029262|Secondary|Mean Change From Baseline in the Emotional Functioning Domain Associated With the EORTC QLQ-C30 Scale at Weeks 12 and 24|"The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).
The EORTC QLQ-C30 Emotional Functioning Scale is scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement."|Baseline, Week 12, ±3 days and Week 24, ±3 days|"Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point (indicated by n ) are included."||units on a scale||95% Confidence Interval|Least Squares Mean
809013|NCT01029262|Secondary|Mean Change From Baseline in the Global Health Status/QoL Domain Associated With the EORTC QLQ-C-30 Scale at Week 12 and Week 24|The European Organization for Research and Treatment of Cancer QOL Questionnaire for Patients with Cancer (EORTC QLQ-C30) was a 30-item oncology-specific questionnaire. The questionnaire was developed to assess the quality of life of cancer patients. It contains 30 questions, 24 of which form 9 multi-item scales representing various aspects of HRQOL: 1 global scale, 5 functional scales (Physical, Role, Emotional, Cognitive and Social), and 3 symptom scales (Fatigue, Pain, and Nausea). The remaining 6 items are intended to be mono-item scales describing relevant cancer-oriented symptoms (dyspnea, insomnia, appetite, constipation, diarrhea, financial difficulties). The EORTC QLQ-C30 Global Health Status/QOL scale was scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in Global Health Status/QOL and positive values indicate improvement.|Baseline, Week 12, ±3 days and Week 24, ±3 days|"Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point (indicated by n) are included."||units on a scale||95% Confidence Interval|Least Squares Mean
809014|NCT01029262|Secondary|Mean Change From Baseline in the Physical Functioning Domain Associated With the EORTC QLQ-C-30 Scale at Week 12 and Week 24|The European Organization for Research and Treatment of Cancer QOL Questionnaire for Patients with Cancer (EORTC QLQ-C30) was a 30-item oncology-specific questionnaire. The questionnaire was developed to assess the quality of life of cancer patients. It contains 30 questions, 24 of which form 9 multi-item scales representing various aspects of HRQOL: 1 global scale, 5 functional scales (Physical, Role, Emotional, Cognitive and Social), and 3 symptom scales (Fatigue, Pain, and Nausea). The remaining 6 items are intended to be mono-item scales describing relevant cancer-oriented symptoms (dyspnea, insomnia, appetite, constipation, diarrhea, financial difficulties). The EORTC QLQ-C30 Physical Functioning was scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in Global Health Status/QOL and positive values indicate improvement.|Baseline, Week 12, ±3 days and Week 24, ±3 days|"Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point (indicated by n) are included."||units on a scale||95% Confidence Interval|Least Squares Mean
809015|NCT01029262|Secondary|Mean Change From Baseline in the Dyspnea Domain Associated With the EORTC QLQ-C-30 Scale at Week 12 and Week 24|"The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).
The EORTC QLQ-C30 Dyspnea scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate decreased dyspnea (i.e. improvement in symptom) and positive values indicate increased dyspnea (i.e. worsening of symptom)."|Baseline, Week 12, ±3 days and Week 24, ±3 days|"Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point (indicated by n) are included."||units on a scale||95% Confidence Interval|Least Squares Mean
809016|NCT01029262|Secondary|Mean Change From Baseline in Fatigue Domain Associated With the EORTC QLQ-C-30 Scale at Week 12 and Week 24|The European Organization for Research and Treatment of Cancer QOL Questionnaire for Patients with Cancer (EORTC QLQ-C30) was a 30-item oncology-specific questionnaire. The questionnaire was developed to assess the quality of life of cancer patients. It contains 30 questions, 24 of which form 9 multi-item scales representing various aspects of HRQOL: 1 global scale, 5 functional scales (Physical, Role, Emotional, Cognitive and Social), and 3 symptom scales (Fatigue, Pain, and Nausea). The remaining 6 items are intended to be mono-item scales describing relevant cancer-oriented symptoms (dyspnea, insomnia, appetite, constipation, diarrhea, financial difficulties). The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reduction in fatigue (i.e. improvement in symptom) and positive values indicate increases in fatigue (i.e. worsening of symptom).|Baseline, Week 12, ±3 days and Week 24, ±3 days|"Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point (indicated by n) are included."||units on a scale||95% Confidence Interval|Least Squares Mean
809048|NCT01029340|Secondary|Part B - The in Vivo Recovery Values of Human Factor VIII (FVIII)|The amount of Factor VIII found in blood samples taken after the injection of the study drug at the beginning of the CS/EP treatment period.|15-30 minutes after the injection|ITT. 1 measurement was taken in all participants at the start of the CS/EP labelled treatment period (CS/ADJ labelled treatment was experimental and will not be used for the future commercial drug, so no measurements were taken). Note: Only 59 of the 62 participants had valid recovery data.||Kg/dL||Inter-Quartile Range|Median
809017|NCT01029262|Secondary|Mean Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Domain at Week 12 and 24|"The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).
The EORTC QLQ-C30 Emotional Functioning Domain was scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement."|Baseline and Week 12, ±3 days and Week 24, ±3 days|"Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point (indicated by n) are included."||units on a scale||Standard Deviation|Mean
809018|NCT01029262|Secondary|Mean Change From Baseline in the EORTC QLQ-C30 Global Health Status/Quality of Life (QOL) Domain at Week 12 and 24|"The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).
The EORTC QLQ-C30 Global Health Status/QOL scale was scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in Global Health Status/QOL and positive values indicate improvement."|Baseline and Week 12, ±3 days and Week 24, ±3 days|"Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point (indicated by n) are included."||units on a scale||Standard Deviation|Mean
809019|NCT01029262|Secondary|Mean Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain at Week 12 and 24|"The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).
The EORTC QLQ-C30 Physical Functioning Scale was scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement."|Baseline and Week 12, ±3 days and Week 24, ±3 days|"Analyses were performed based on the Health Related Quality of Life (HRQoL) evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point (indicated by n) are included."||units on a scale||Standard Deviation|Mean
809020|NCT01029262|Secondary|Mean Change From Baseline in the EORTC QLQ-C30 Dyspnea Domain at Week 12 and 24|"The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).
The EORTC QLQ-C30 Dyspnea scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate decreased dyspnea (i.e. improvement in symptom) and positive values indicate increased dyspnea (i.e. worsening of symptom)."|Baseline and Week 12, ±3 days and Week 24, ±3 days|"Analyses were performed based on the Health Related Quality of Life (HRQoL) evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point (indicated by n are included)."||units on a scale||Standard Deviation|Mean
809021|NCT01029262|Secondary|Mean Change From Baseline in the EORTC QLQ-C30 Fatigue Domain at Week 12 and 24|"The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).
The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reduction in fatigue (i.e. improvement in symptom) and positive values indicate increases in fatigue (i.e. worsening of symptom)."|Baseline and Week 12, ±3 days and Week 24, ±3 days|"Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point (indicated by n) are included."||units on a scale||Standard Deviation|Mean
809022|NCT01029262|Primary|Percentage of Participants With a Erythroid Gene Signature Who Achieved RBC Transfusion Independence for ≥ 56 Days as Determined by an Independent Review Committee (IRC)|"The percentage of participants who achieved the 56-day RBC TI response was defined as the absence of any RBC transfusions during any consecutive rolling 56-day interval within the double-blind treatment phase (ie, Days 2 (Day 1 is the first study drug day) to 57, Days 3 to 58, etcetera). A participant who achieved at least a 56-day RBC-transfusion-independent response was considered a 56-day RBC-TI responder."|Up to 49 months; Up to data cut-off of 17 Mar 2014; maximum exposure to study drug was 1158 days|Analysis population includes ITT participants with an erythroid gene expression signature with a positive response||percentage of participants|||Number
809049|NCT01029340|Primary|Part B - Annualized Number of Total Bleeds|The annualized number of bleeds experienced by participants|12 months after randomization|Intent to treat (ITT)||Bleeds||Inter-Quartile Range|Median
820718|NCT01147497|Secondary|Patient Perceived Pain on a 100 Point Visual Analogue Scale|The visual analogue scale for perceived patient pain ranges from 0 (no pain) to 100 (most pain).|immediately after insertion|||units on a scale||Full Range|Median
809023|NCT01029262|Secondary|Compliance Rates Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) From Baseline to Week 48|The European Organization for Research and Treatment of Cancer QOL Questionnaire for Patients with Cancer (EORTC QLQ-C30) was a 30-item oncology-specific questionnaire. The questionnaire was developed to assess the quality of life of cancer patients. It contains 30 questions, 24 of which form 9 multi-item scales representing various aspects of HRQOL: 1 global scale, 5 functional scales (Physical, Role, Emotional, Cognitive and Social), and 3 symptom scales (Fatigue, Pain, and Nausea). The remaining 6 items are intended to be mono-item scales describing relevant cancer-oriented symptoms (dyspnea, insomnia, appetite, constipation, diarrhea, financial difficulties). Subscale scores are transformed to a 0 to 100 scale, with higher scores on functional scales indicating better function and higher score on symptom scales indicating worse symptoms. A participant was considered compliant at a visit if at least 15 out of the QLQ-C30 items in the questionnaire were checked.|Baseline, Week 12, (±3 days), Week 24, (±3 days), Week 36, (±3 days), and Week 48 (±3 days); up to data cut-off of 17 Mar 2014|Analyses were performed based on the Health Related Quality of Life (HRQoL) evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Data is available up to Week 48 due to small sample after that.||percentage of participants|||Number
809024|NCT01029262|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAE)|"A TEAE was defined as an AE that begins or worsens in intensity of frequency on or after the first dose of study drug through 28 days after last dose of study drug.
A serious adverse event (SAE) is any:
Death;
Life-threatening event;
Any inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability or incapacity;
Congenital anomaly or birth defect;
Any other important medical event
The investigator determined the relationship of an AE to study drug based on the timing of the AE relative to drug administration and whether or not other drugs, therapeutic interventions, or underlying conditions could provide a sufficient explanation for the event. The severity of an AE was evaluated by the investigator according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (Version 3.0) where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death."|From the first dose of study drug through 28 days after discontinuation from the study treatment; up to data cut-off of 17 Mar 2014; maximum exposure to study drug was 1158 days|Safety population includes all patients who received at least 1 dose of study drug.||participants|||Number
809025|NCT01029262|Secondary|Kaplan Meier Estimate for Overall Survival (OS)|Overall survival was assessed using the time between randomization and the date of death or date of censoring. Participants who were alive at a data cutoff date and participants who were lost to follow-up were censored at the last date when participants were known to be alive.|Up to 49 months; From randomization to data cut-off of 17 Mar 2014; maximum exposure to study drug was 1158 days|Intent to treat population was all participants who were randomized.||years||95% Confidence Interval|Median
809026|NCT01029262|Secondary|Kaplan Meier Estimates for Progression to Acute Myeloid Leukemia (AML)|Progression to AML is part of the natural course of MDS and is a manifestation of disease progression. The time to progress to AML was calculated from the day of randomization to the first day when AML was diagnosed. Participants who died without AML were censored at the date of death. The participants who were lost to follow-up were censored at the last known day when participants did not have AML. Participants who did not progress to AML at the last follow-up contact were censored at the day of the last follow-up contact.|Up to 49 months; From Randomization to Data Cut-Off 17 March 2014; Maximum exposure to study drug was 1158 days|Intent to treat population includes all participants who were randomized and received either Lenalidomide or Placebo. One participant in the placebo arm was diagnosed as having AML before enrollment and was excluded from all analyses of progression to AML.||years||95% Confidence Interval|Median
809027|NCT01029262|Secondary|Time to 56-Day RBC-Transfusion-independent Response as Determined by the Sponsor|The time to the first 56-day RBC-transfusion-independent response was calculated for participants who achieved a response. The day from the first dose of study drug to the date at which RBC-transfusion-independence starts was achieved and calculated using: Start date of the first response period – the date of the first study drug +1. A responder was defined as a participant who had a ≥ 56 consecutive days of RBC-transfusion-free period after the first dose of study drug in the treatment phase.|From the first dose of study drug to Day 56|The analysis was conducted only for those participants who achieved a 56-day TI response according to the sponsor's assessment. Responders in the intent to treat population.||weeks||Full Range|Median
809028|NCT01029262|Secondary|Percentage of Participants Who Achieved an Erythroid Response Based on Modified International Working Group (IWG) 2006 Criteria|"A participant was considered as having achieved an erythroid response if the participant either:
- had a hemoglobin (Hgb) increase ≥1.5 g/dL compared to baseline and confirmed by another central laboratory hemoglobin value at 4 to 8 weeks after the first Hgb measurement that also increased ≥1.5 g/dL. All Hgb values during this time interval must have had a ≥ 1.5 g/dL increase (ie, no central laboratory Hgb increase during this timeframe could be less <1.5 g/dL). The duration of Hgb increase is from the date of a first ≥1.5 g/dL increase to the last date when Hgb value still have a ≥1.5 g/dL increase.
OR
- had a 50% reduction in the number of the RBC transfusion units over any consecutive 56 days period compared to the baseline transfusion burden.
The baseline transfusion burden is the number of units over 112 days by the randomization divided by 2. Only transfusions given for a pre-transfusion Hgb value of 9 g/dL or less may be used in this response assessment."|Up to 49 months; From Randomization to Data Cut-Off 17 March 2014; Maximum exposure on study drug was1158 days|The Intent-to-Treat (ITT) population includes all participants who were randomized to either Lenalidomide or placebo.||percentage of participants|||Number
809050|NCT01029340|Primary|Part A - Half-life (t 1/2)|To examine the PK characteristics of BAY81-8973 and ensure that the new drug is similar to Kogenate FS. All results are based on the chromogenic assay.|Samples taken at pre-injection, and at 0.25, 0.5, 1, 3, 6, 8, 24, 30 and 48 hours post injection.|PK Analysis Population||Hours (h)||Geometric Coefficient of Variation|Geometric Mean
809051|NCT01029340|Primary|Part A - Area Under the Drug Concentration-time Curve (AUC)|To examine the Pharmacokinetic (PK) characteristics of BAY 81-8973 and ensure that the new drug is similar to Kogenate FS. All results are based on the chromogenic assay.|Samples taken at pre-injection, and at 0.25, 0.5, 1, 3, 6, 8, 24, 30 and 48 hours post injection. AUC calculated from time of injection to infinity.|PK Analysis Population||Int.units x hours/deciliters (IU*h/dL)||Geometric Coefficient of Variation|Geometric Mean
809029|NCT01029262|Secondary|Kaplan Meier Estimates of Duration of 56-day RBC TI Response as Determined by the Sponsor|"The duration of the first 56-day RBC transfusion-independence response was calculated for those who achieved a response and was dependent on whether a subsequent RBC transfusion was given after the transfusion-free period (response):
for those who received a subsequent RBC transfusion after the response starts, the duration of response was not censored, and was calculated as response duration = last day of response – first day of response +1 where the last day of response was defined as 1 day before the first RBC transfusion which was given at 56 days or more after the response starts.
for those who did not receive a subsequent RBC transfusion after the response started, the end day of the response was censored and duration of the response was calculated as response duration = date of last RBC transfusion assessment – first day of response+ 1. A responder was a participant who had a ≥ 56 consecutive days of RBC-transfusion-free period after the first study drug treatment period"|Up to 49 months; from randomization to data cut-off of 17 Mar 2014; maximum exposure to study drug was 1158 days|The analysis was conducted only for those participants who achieved a 56-day TI response according to the sponsor's assessment. Responders in the intent to treat population.||weeks||95% Confidence Interval|Median
809030|NCT01029262|Post-Hoc|Percentage of Participants Who Achieved an Erythroid Response Based on Original IWG 2006 Criteria|"A participant was considered as having achieved an erythroid response when:
- a Hgb increase ≥1.5 g/dL compared to baseline and confirmed by another central laboratory hemoglobin value at 4 to 8 weeks after the first Hgb measurement that had also increased ≥1.5 g/dL. All Hgb values during this time interval must have had a ≥ 1.5 g/dL increase (ie, no central laboratory Hgb increase during this timeframe can be less than a 1.5 g/dL). The duration of Hgb increase is from the date of a first ≥1.5 g/dL increase to the last date when Hgb value still have a ≥1.5 g/dL increase.
OR
- had an absolute reduction of 4 RBC transfusion units over any consecutive 56 days period compared to the baseline transfusion burden.
The baseline transfusion burden is the number of units over 112 days by the randomization divided by 2. Only transfusions given for a pre-transfusion Hgb value of 9.5 g/dL or less may be used in this response assessment."|Up to 49 months; from randomization to data cut-off of 17 Mar 2014; maximum exposure to study drug was 1158 days|Intent to treat population includes all participants who were randomized and received at least one dose of study drug.||percentage of participants|||Number
809031|NCT01029262|Secondary|Percentage of Participants Who Achieved RBC Transfusion Independence With a Duration of ≥ 24 Weeks (168 Days) as Determined by the Sponsor|The 168-day RBC-transfusion-independent response was defined as the absence of any RBC transfusion during any consecutive “rolling” 168 days during the treatment period, for example Days 2 (Day 1 is the first study drug day) to 169, Days 3 to 170, Days 4 to 171, etcetera. A responder was defined as a participant who had a ≥ 168 consecutive days of RBC-transfusion-free period after the first dose of study drug in the treatment phase.|Up to 49 months; From randomization to the data cut-off of 17 Mar 2014; maximum exposure to study drug was 1158 days|The Intent-to-Treat (ITT) population includes all participants who were randomized to either Lenalidomide or placebo.||percentage of participants|||Number
809032|NCT01029262|Primary|Percentage of Participants Who Achieved Red Blood Cell (RBC) Transfusion Independence for ≥ 56 Days as Determined by an Independent Review Committee (IRC)|The percentage of participants who achieved the 56-day RBC transfusion independent (TI) response was defined as the absence of any RBC transfusions during any consecutive “rolling” 56-day interval within the double-blind treatment phase (ie, Days 2 (Day 1 is the first study drug day) to 57, Days 3 to 58, etcetera). The double-blind treatment phase was defined as the period between the 1st dosing up until 28 days after the last study drug dose|Up to 49 months; From randomization to the data cut-off of 17 Mar 2014; maximum exposure to study drug was 1158 days|The Intent-to-Treat (ITT) population includes all participants who were randomized to either Lenalidomide or placebo.||percentage of participants|||Number
809033|NCT01029340|Secondary|Part C - Number of Participants With Assessment of the Hemostasis During Major Surgery|An assessment made by surgeons of how effective BAY81-8973 was in stopping bleeding during major operations|at the time of surgery|ITT||Participants|||Number
809034|NCT01029340|Secondary|Part B - Number of Participants With Assessment of the Hemostasis During Major Surgery|An assessment made by surgeons of how effective BAY81-8973 was in stopping bleeding during major operations|An average of 1 month after start of treatment|ITT||Participants|||Number
809035|NCT01029340|Secondary|Part C - Number of Participants With Incidence of Antibody Formation to Host Cell Proteins (HCP)|A test to ensure that participants have not developed antibodies to HCP during the study|before and 3 weeks after surgery|ITT||Participants|||Number
809036|NCT01029340|Secondary|Part B - Number of Participants With Incidence of Antibody Formation to Host Cell Proteins (HCP)|A test to ensure that participants have not developed antibodies to HCP during the study|Up to 12 months after drug administration|ITT||Participants|||Number
809037|NCT01029340|Secondary|Part A - Number of Participants With Incidence of Antibody Formation to Host Cell Proteins (HCP)|A test to ensure that participants have not developed antibodies to HCP during the study|Up to 4 weeks after drug administration|ITT||Participants|||Number
809038|NCT01029340|Secondary|Part C - Number of Participants With Incidence of Antibody Formation to Heat-shock Protein (HSP-70)|A test to analyze the formation of antibodies to HSP-70|before and 3 weeks after surgery|ITT||Participants|||Number
809039|NCT01029340|Secondary|Part B - Number of Participants With Incidence of Antibody Formation to Heat-shock Protein (HSP-70)|A test to analyze the formation of antibodies to HSP-70|Up to 12 months after drug administration|ITT||Participants|||Number
809040|NCT01029340|Secondary|Part A - Number of Participants With Incidence of Antibody Formation to Heat-shock Protein (HSP-70)|A test to analyze the formation of antibodies to HSP-70|Up to 6 weeks after drug administration|Safety population||Participants|||Number
809041|NCT01029340|Secondary|Part C - Number of Participants With Incidence of Inhibitory Antibody Formation|A test to ensure that participants have not developed antibodies that will interfere with the action of BAY81-8973|before and 3 weeks after surgery|ITT||Participants|||Number
809042|NCT01029340|Secondary|Part B - Number of Participants With Incidence of Inhibitory Antibody Formation|A test to ensure that participants have not developed antibodies that will interfere with the action of BAY81-8973|Up to 12 months after drug administration|Safety population||Participants|||Number
809043|NCT01029340|Secondary|Part A - Number of Participants With Inhibitory Antibody Formation|A test to ensure that participants have not developed antibodies that will interfere with the action of BAY81-8973|Up to 6 weeks after first injection of study drug|Safety population||Participants|||Number
809052|NCT01029366|Secondary|Overall Response Summary|"Efficacy assessments for ALL were performed based on bone marrow and blood morphologic criteria and physical examination findings. The definitions for response are primarily based on the standardized response criteria defined by National Comprehensive Cancer Network (NCCN) Guidelines (NCCN, 2013 v.1).
Efficacy assessments for CLL were based on lymphadenopathy, hepatomegaly, splenomegaly, bone marrow and blood morphologic and laboratory assessments. The response criteria are consistent with NCCN Guidelines Version 2.2012 CLL/SLL, which is based on the 2008 International Workshop Group on CLL (IWCLL) revisions of the original guidelines for evaluating disease response released in 1996 by the National Cancer Institute Working Group (NCI/WG)."|5 years|||percentage of participants|||Number
809053|NCT01029366|Primary|Number of Participants With Adverse Events||5 years|||participants|||Number
809054|NCT01029392|Secondary|Change in Insulin Requirements|Percentage change from baseline number of units of lantus insulin over 6 months.|6 months|20 patients in the Vitamin D Supplement arm and 11 patients in the No-Vitamin D supplement arm were withdrawn and not analyzed.||percentage change of baseline insulin||Standard Deviation|Mean
809055|NCT01029392|Primary|Change in Hemoglobin A1c|Change in hemoglobin A1c calculated as a percentage change from baseline measurement|6 months|20 patients in the Vitamin D Supplement arm and 11 patients in the No-Vitamin D supplement arm were withdrawn and not analyzed.||percentage change from baseline||Standard Deviation|Mean
809056|NCT01029405|Secondary|Percentage of Participants With Greater Decrease In OTPSS: Ointment (0.5 % Once Daily, 0.5% Twice Daily and 2% Once Daily), Vehicle|OTPSS is a scale to assess plaque severity. Each target plaque was scored by the investigator on severity scale ranging from 0 (no plaque) to 8 (very severe plaque), where higher scores indicated more severity of a plaque. In this outcome measure, percentage of participants with reduced OTPSS in ointment (0.5 % once daily, 0.5% twice daily and 2% once daily) treated plaque versus vehicle treated plaque and percentage of participants with reduced OTPSS in vehicle treated plaque versus ointment (0.5 % once daily, 0.5% twice daily and 2% once daily) treated plaque respectively at Day 42 are reported.|Day 42|Intent-to-treat population included all randomized participants who received the study medication.||percenatge of participants|||Number
809057|NCT01029405|Primary|Percentage of Participants With Greater Decrease In Overall Target Plaque Severity Score (OTPSS): Ointment (2% Twice Daily), Vehicle|OTPSS is a scale to assess plaque severity. Each target plaque was scored by the investigator on severity scale ranging from 0 (no plaque) to 8 (very severe plaque), where higher score indicates more severity of a plaque. In this outcome measure, percentage of participants with reduced OTPSS in ointment (2% twice daily) treated plaque versus (vs.) vehicle treated plaque and percentage of participants with reduced OTPSS in vehicle treated plaque versus ointment (2% twice daily) treated plaque respectively at Day 42 are reported.|Day 42|Intent-to-treat population included all randomized participants who received study medication.||percenatge of participants|||Number
809058|NCT01029535|Secondary|Percentage of Participants Satisfied or Very Satisfied With the Treatment|Participants rated their satisfaction with treatment using a 5-Point Scale where: 1=very unsatisfied to 5=very satisfied.|Week 8|Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.||percentage of participants|||Number
809059|NCT01029535|Secondary|Change From Baseline in the Subject’s Self-Perception of Age (SPA)|The participant rated their facial age in years at Baseline and Weeks 4, 8, 52, 78 and 104. A negative change from Baseline indicates an improvement.|Baseline, Weeks 4, 8, 52, 78 and 104|Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.||years||Standard Deviation|Mean
809060|NCT01029535|Secondary|Subject’s Assessment of Global Aesthetic Improvement Score (GAIS)|The participant rated their midface appearance compared to Baseline (before treatment) using the 5-point GAIS scale:-2=much worse to +2=much improved.|Baseline, Weeks 4, 8, 52, 78 and 104|Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.||score on a scale||Standard Deviation|Mean
809061|NCT01029535|Secondary|Physician Assessment of Global Aesthetic Improvement Score (GAIS)|The physician rated the participant’s midface appearance compared to Baseline (before treatment) using the 5-point GAIS scale:-2=much worse to +2=much improved.|Baseline, Weeks 4, 8, 52, 78 and 104|Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.||score on a scale||Standard Deviation|Mean
809062|NCT01029535|Secondary|Change From Baseline in the MFVDS Score|The physician determined the degree of midface volume deficiency in each participant, relative to Baseline (before treatment) using the 6-point MFVDS where: 0=no facial volume loss to 5=severe volume loss. A negative change from Baseline indicates improvement.|Baseline, Weeks 4, 8, 52, 78 and 104|Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.||score on a scale||Standard Deviation|Mean
809063|NCT01029535|Secondary|Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Investigator’s Wrinkle Assessment Scale (WAS)|The physician assessed the left side and the right side of the participant’s face for severity of nasolabial folds using the 5-point WAS where: 0=no wrinkle to 4=very deep wrinkle.|Baseline, Weeks 4, 8, 52, 78 and 104|Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.||percentage of participants|||Number
809064|NCT01029535|Primary|Percentage of Participants Who Maintained Their Week 8 Physician’s GAIS Scores at Week 104|The physician rated the participant’s midface appearance compared to before treatment at Week 8 and Week 104 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported.|Baseline, Week 8, Week 104|ITT population included all enrolled participants who received at least one application of VOLUMA™.||percentage of participants|||Number
809065|NCT01029535|Primary|Percentage of Participants Who Maintained Their Week 8 Physician’s GAIS Scores at Week 78|The physician rated the participant’s midface appearance compared to before treatment at Week 8 and Week 78 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported.|Baseline, Week 8, Week 78|ITT population included all enrolled participants who received at least one application of VOLUMA™.||percentage of participants|||Number
823009|NCT01166997|Primary|Reduction of RV/LV Ratio|Change in the end-diastolic RV/LV ratio from baseline to 24 hours by echocardiography.|24 hours|||Ratio||Standard Deviation|Mean
809066|NCT01029535|Primary|Percentage of Participants Who Maintained Their Week 8 Physician’s GAIS Scores at Week 52|The physician rated the participant’s midface appearance compared to before treatment at Week 8 and Week 52 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported.|Baseline, Week 8, Week 52|ITT population included all enrolled participants who received at least one application of VOLUMA™.||percentage of participants|||Number
809067|NCT01029535|Primary|Percentage of Participants Who Maintained Their Week 8 Subject’s GAIS Scores at Week 104|The participant rated their midface appearance compared to before treatment at Week 8 and Week 104 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported.|Baseline, Week 8, Week 104|ITT population included all enrolled participants who received at least one application of VOLUMA™.||percentage of participants|||Number
809068|NCT01029535|Primary|Percentage of Participants Who Maintained Their Week 8 Subject’s GAIS Scores at Week 78|The participant rated their midface appearance compared to before treatment at Week 8 and Week 78 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported.|Baseline, Week 8, Week 78|ITT population included all enrolled participants who received at least one application of VOLUMA™.||percentage of participants|||Number
809069|NCT01029535|Primary|Percentage of Participants Who Maintained Their Week 8 Subject’s GAIS Scores at Week 52|The participant rated their midface appearance compared to before treatment at Week 8 and Week 52 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported.|Baseline, Week 8, Week 52|ITT population included all enrolled participants who received at least one application of VOLUMA™.||percentage of participants|||Number
809070|NCT01029535|Primary|Percentage of Participants Who Maintained Their Week 8 MFVDS Scores at Week 104|The physician determined the degree of midface volume deficiency in each participant at week 8 and Week 104, relative to before treatment using the 6-point MFVDS: 0-no facial volume loss to 5=severe volume loss. The percentage of participants who are able to maintain their Week 8 score is reported.|Baseline, Week 8, Week 104|ITT population included all enrolled participants who received at least one application of VOLUMA™.||percentage of participants|||Number
809071|NCT01029535|Primary|Percentage of Participants Who Maintained Their Week 8 MFVDS Scores at Week 78|The physician determined the degree of midface volume deficiency in each participant at week 8 and Week 78, relative to before treatment using the 6-point MFVDS: 0-no facial volume loss to 5=severe volume loss. The percentage of participants who are able to maintain their Week 8 score is reported.|Baseline, Week 8, Week 78|ITT population included all enrolled participants who received at least one application of VOLUMA™.||percentage of participants|||Number
809072|NCT01029535|Primary|Percentage of Participants Who Maintained Their Week 8 MFVDS Scores at Week 52|The physician determined the degree of midface volume deficiency in each participant at week 8 and Week 52, relative to before treatment using the 6-point MFVDS: 0-no facial volume loss to 5=severe volume loss. The percentage of participants who are able to maintain their Week 8 score is reported.|Baseline, Week 8, Week 52|ITT population included all enrolled participants who received at least one application of VOLUMA™.||percentage of participants|||Number
809073|NCT01029535|Primary|Percentage of Participants a ≥ 1 Point Improvement From Baseline in the Physician’s Mid-face Volume Deficit Scale (MFVDS) at Week 8|The physician determined the degree of midface volume deficiency in each participant, relative to Baseline (before treatment) using the 6-point MFVDS: 0=no facial volume loss to 5=severe volume loss.|Baseline, Week 8|Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.||percentage of participants|||Number
809074|NCT01029535|Primary|Percentage of Participants a ≥1 Point Improvement From Baseline in the Physician’s Mid-face Volume Deficit Scale (MFVDS) at Week 4|The physician determined the degree of midface volume deficiency in each participant, relative to Baseline (before treatment) using the 6-point MFVDS: 0=no facial volume loss to 5=severe volume loss.|Baseline, Week 4|ITT population included all enrolled participants who received at least one application of VOLUMA™.||percentage of particpants|||Number
809075|NCT01029535|Primary|Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Physician’s Global Aesthetic Improvement Scale (GAIS) at Week 8|The physician rated the participant’s midface appearance compared to Baseline (before treatment) using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants +1=improved and +2=much improved is reported.|Baseline, Week 8|Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.||percentage of particpants|||Number
809076|NCT01029535|Primary|Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Physician’s Global Aesthetic Improvement Scale (GAIS) at Week 4|The physician rated the participant’s midface appearance compared to Baseline (before treatment) using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants +1=improved and +2=much improved is reported.|Baseline, Week 4|Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.||percentage of participants|||Number
809077|NCT01029535|Primary|Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Subject’s Global Aesthetic Improvement Scale (GAIS) at Week 8|The participant rated their midface appearance compared to Baseline (before treatment) using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants +1=improved and +2=much improved is reported.|Baseline, Week 8|Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.||percentage of participants|||Number
809078|NCT01029535|Primary|Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Subject’s Global Aesthetic Improvement Scale (GAIS) at Week 4|The participant rated their midface appearance compared to Baseline (before treatment) using the 5-point GAIS scale where:-2=much worse to +2=much improved. The percentage of participants +1=improved and +2=much improved is reported.|Baseline, Week 4|Participants from the intent-to-treat (ITT) population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.||percentage of participants|||Number
821666|NCT01155063|Secondary|Time to Discontinuation of Study Medication||Month 0 up to Month 36 or early withdrawal|Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study.|||||
809079|NCT01029652|Secondary|Physician's Assessment of Erythema for Patients Re-treated or Switched to Canakinumab|The study physician assessed the most affected joint for Erythema: Present or absent. The percentage of patients in each category is reported. The treatment effect reported for canakinumab arm was for last post-baseline flare after re-treated with canakinumab and for patient which switched to Canakinumab arm was for first post-baseline flare after receiving the first dose of canakinumab.|72 hours post-dose , 7 days post dose for the last post-baseline flare for patients re-treated with canakinumab or the first post-baseline flare treated with canakinumab for patients who switched treatment (during 72 weeks overall)|Modified Analysis Set (MAS) consists of all FAS patients who were either re-treated or switched to canakinumab during 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.||Percentage of participants|||Number
809080|NCT01029652|Secondary|Physician's Assessment of Joint Swelling for Patients Re-treated or Switched to Canakinumab|The study physician assessed the most affected joint for: Swelling on a 0-3 point scale: No swelling, palpable, visible, and bulging beyond the joint margins; The percentage of patients in each category is reported. The treatment effect reported for canakinumab arm was for last post-baseline flare after re-treated with canakinumab and for patient which switched to Canakinumab arm was for first post-baseline flare after receiving the first dose of canakinumab.|72 hours post-dose , 7 days post dose last post-baseline flare for patients re-treated with canakinumab or the first post-baseline flare treated with canakinumab for patients who switched treatment (during 72 weeks overall)|Modified Analysis Set (MAS) consists of all FAS patients who were either re-treated or switched to canakinumab during 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.||Percentage of participants|||Number
809081|NCT01029652|Secondary|Physician's Assessment of Joint Tenderness for Patients Re-treated or Switched to Canakinumab|The study physician assessed the most affected joint for: Tenderness on a 0-3 point scale: No pain, patient states that “there is pain”, patient states “there is pain and winces”, and patient states “there is pain, winces, and withdraws” on palpation or passive movement of the affected study joint; The percentage of patients in each category is reported. The treatment effect reported for canakinumab arm was for last post-baseline flare after re-treated with canakinumab and for patient which switched to Canakinumab arm was for first post-baseline flare after receiving the first dose of canakinumab.|72 hours post-dose , 7 days post dose last post-baseline flare for patients re-treated with canakinumab or the first post-baseline flare treated with canakinumab for patients who switched treatment (during 72 weeks overall)|Modified Analysis Set (MAS) consists of all FAS patients who were either re-treated or switched to canakinumab during 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.||Percentage of participants|||Number
809082|NCT01029652|Secondary|Patient's Global Assessment of Response to Treatment for Patients Re-treated or Switched to Canakinumab|Patients made a global assessment of response to treatment using a 5-point Likert scale: Excellent, good, acceptable, slight, poor. Percentage of participants in each category for both core and extension periods were measured. The treatment effect reported for canakinumab arm was for last post-baseline flare after re-treated with canakinumab and for patient which switched to Canakinumab arm was for first post-baseline flare after receiving the first dose of canakinumab.|72 hours post-dose , 7 days post dose for the last post-baseline flare for patients re-treated with canakinumab or the first post-baseline flare treated with canakinumab for patients who switched treatment (during 72 weeks overall)|Modified Analysis Set (MAS) consists of all FAS patients who were either re-treated or switched to canakinumab during 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.||Percentage of participants|||Number
809083|NCT01029652|Secondary|Patient's Assessment of Gout Pain Intensity in the Currently Most-affected Joint (Likert Scale)|Participant scored their current pain intensity in the most affected joint of the gout flare on a 5-point Likert Scale (none, mild, moderate, severe, extreme). It participant had a new flare, they also scored the maximum amount of acute gout pain in the most affected joint since the onset of a new flare on 5 point Likert scale (none, mild, moderate, severe, extreme). The treatment effect reported for canakinumab arm was for last post-baseline flare after re-treated with canakinumab and for patient which switched to Canakinumab arm was for first post-baseline flare after receiving the first dose of canakinumab.|72 hours post-dose , 7 days post dose for the last post-baseline flare for patients re-treated with canakinumab or the first post-baseline flare treated with canakinumab for patients who switched treatment (during 72 weeks overall)|Modified Analysis Set (MAS) consists of all FAS patients who were either re-treated or switched to canakinumab during 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.||Percentage of participants|||Number
809084|NCT01029652|Secondary|Physician's Global Assessment of Response to Treatment for Patients Re-treated or Switched to Canakinumab|The study physician made a global assessment of the patient's response to treatment using a 5-point Likert scale: Very good, good, fair, poor, very poor. The percentage of patients in each category is reported. The physician completed the assessment without viewing any of the patient's assessments (pain intensity [Visual Analog Scale and Likert scale] and patient's global assessment of response to treatment). The treatment effect reported for canakinumab arm was for last post-baseline flare after re-treated with canakinumab and for patient which switched to Canakinumab arm was for first post-baseline flare after receiving the first dose of canakinumab.|72 hours post-dose , 7 days post-dose for the last post-baseline flare for patients re-treated with canakinumab or first post-baseline flare treated with canakinumab for patients switched treatment (during 72 weeks overall)|Modified Analysis Set (MAS) consists of all FAS patients who were either re-treated or switched to canakinumab during 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.||Percentage of participants|||Number
809085|NCT01029652|Primary|Number of Participants With Adverse Events (AE), Death and Serious Adverse Events (72 Weeks Overall)|This was the primary endpoint of both extension studies. Adverse event is defined as any unfavorable and unintended diagnosis, symptom, sign(including an abnormal laboratory finding),syndrome or disease which either occurs during the study, having been absent at baseline, or,if present at baseline, appears to worsen. Serious adverse event is defined as any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.|72 weeks overall|Safety population consisted of all patients who received study drug in the core study and had at least one post-baseline safety assessment.||Participants|||Number
809086|NCT01029652|Secondary|Serum Amyloid A Protein (SAA) Levels for Patients Re-treated With or Switched to Canakinumab|Serum Amyloid A Protein (SAA) levels were determined in blood serum in order to identify the presence of inflammation, to determine its severity, and to monitor the response to treatment. Analytes were measured by a central laboratory. The treatment effect reported for canakinumab arm was for last post-baseline flare after re-treated with canakinumab and for patient which switched to Canakinumab arm was for first post-baseline flare after receiving the first dose of canakinumab.|24 hours, 72 hours, 7 days, 4 weeks, 8 weeks and 12 weeks post-dose for the last post-baseline flare for patients re-treated with canakinumab or first post-baseline flare treated with canakinumab for patients switched treatment (during 72 weeks overall)|Modified Analysis Set (MAS) consists of all FAS patients who were either re-treated or switched to canakinumab during 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included||mg/L||Standard Deviation|Mean
809087|NCT01029652|Secondary|High-sensitivity C-reactive Protein (hsCRP) Levels for Patients Re-treated With or Switched to Canakinumab|High sensitivity C-reactive protein (hsCRP) levels were determined in blood serum in order to identify the presence of inflammation, to determine its severity, and to monitor the response to treatment. Analytes were measured by a central laboratory. The treatment effect reported for canakinumab arm was for last post-baseline flare after re-treated with canakinumab and for patient which switched to Canakinumab arm was for first post-baseline flare after receiving the first dose of canakinumab.|24 hours, 72 hours, 7 days, 4 weeks, 8 weeks and 12 weeks post-dose for the last post-baseline flare for patients re-treated with canakinumab or first post-baseline flare treated with canakinumab for patients switched treatment (during 72 weeks overall)|Modified Analysis Set (MAS) consists of all FAS patients who were either re-treated or switched to canakinumab during 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included||mg/L||Standard Deviation|Mean
809088|NCT01029652|Secondary|Flare Rate Per Year|"Flare rate was calculated as the number of new flares over the period of observation in years. Flare rate was calculated using only those new flares before switching to canakinumab.
Patients met definition of new flare if they had:
Flare in joint, not a previously affected joint (at baseline or during study)
Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.
Patients did not meet criterion of having new gout flare if:
· Increasing/renewed gout pain in an affected joint before the flare has resolved completely."|72 weeks overall|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.||New flares per patient per year||Standard Deviation|Mean
809089|NCT01029652|Secondary|Time to First New Flare: Survival Analysis by Treatment (72 Weeks Overall)|"Kaplan-Meier estimates of time to first new flare and confidence intervals were determined. For patients with event, time to event = (date of event – date of first dose of study drug + 1).
Patients met definition of new flare if they had:
Flare in joint, not a previously affected joint (at baseline or during study)
Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.
Patients did not meet criterion of having new gout flare if:
· Increasing/renewed gout pain in an affected joint before flare has resolved completely."|72 weeks overall|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.||days||95% Confidence Interval|Median
809090|NCT01029652|Secondary|Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale)|Participant scored their current pain intensity in the most affected joint of the gout flare on a 5-point Likert Scale (none, mild, moderate, severe, extreme). It participant had a new flare, they also scored the maximum amount of acute gout pain in the most affected joint since the onset of a new flare on 5 point Likert scale (none, mild, moderate, severe, extreme).|7 days post dose (randomization), 24 weeks post-dose|Full Analysis Set includes all patients that received study drug. 'N' in each category indicates participants with observations analyzed for this endpoint at specified time points.||Percentage of participants|||Number
809091|NCT01029652|Secondary|Physician’s Assessment of Range of Motion of the Most Affected Joint|The study physician assessed the range of motion of the most affected joint for range of motion on a 5-point Likert scale: Normal, mildly restricted, moderately restricted, severely restricted, immobilized. The percentage of patients in each category is reported.|72 hours post-dose (randomization), 72 hours post-dose for the last post-baseline flare (24 weeks overall)|Full Analysis Set (FAS): All patients that received study drug. 'N' in each category indicates participants with observations analyzed for this endpoint at specified time points.||Percentage of participants|||Number
809092|NCT01029652|Secondary|Physician’s Assessment of Tenderness, Swelling, and Erythema of the Most Affected Joint|The study physician assessed the most affected joint for: Tenderness on a 0-3 point scale: No pain, patient states that “there is pain”, patient states “there is pain and winces”, and patient states “there is pain, winces, and withdraws” on palpation or passive movement of the affected study joint; Swelling on a 0-3 point scale: No swelling, palpable, visible, and bulging beyond the joint margins; and Erythema: Present or absent. The percentage of patients in each category is reported.|72 hours post-dose (randomization), 72 hours post-dose for the last post-baseline flare (during 24 weeks overall)|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. 'N' in each category indicates participants with observations analyzed for this endpoint at specified time points.||Percentage of participants|||Number
809093|NCT01029652|Primary|Number of Participants With Adverse Events (AE), Death and Serious Adverse Events (24 Weeks Overall)|This was the primary endpoint of both extension studies. Adverse event is defined as any unfavorable and unintended diagnosis, symptom, sign(including an abnormal laboratory finding),syndrome or disease which either occurs during the study, having been absent at baseline, or,if present at baseline, appears to worsen. Serious adverse event is defined as any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.|24 weeks overall|Safety population consisted of all patients who received study drug in the core study and had at least one post-baseline safety assessment.||Participants|||Number
809619|NCT01043926|Secondary|Number of Participants With an Adverse Event (AE)|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug.|From administration of study drug through 14 days after administration of study drug|All Treated Participants||participants|||Number
809094|NCT01029652|Secondary|Patient’s Global Assessment of Response to Treatment|Patients made a global assessment of response to treatment using a 5-point Likert scale: Excellent, good, acceptable, slight, poor. Percentage of participants in each category for both core and extension periods were measured.|72 hours post-dose (randomization), 72 hours post-dose for the last post-baseline flare (during 24 weeks overall)|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. 'N' in each category indicates participants with observations analyzed for this endpoint at specified time points.||Percentage of participants|||Number
809095|NCT01029652|Secondary|Physician’s Global Assessment of Response to Treatment|The study physician made a global assessment of the patient’s response to treatment using a 5-point Likert scale: Very good, good, fair, poor, very poor. The percentage of patients in each category is reported. The physician completed the assessment without viewing any of the patient’s assessments (pain intensity [Visual Analog Scale and Likert scale] and patient’s global assessment of response to treatment).|72 hours post-dose (randomization), 72 hours post-dose for the last post-baseline flare (during 24 weeks overall)|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. 'N' in each category indicates participants with observations analyzed for this endpoint at specified time points.||Percentage of participants|||Number
809096|NCT01029652|Secondary|High-sensitivity C-reactive Protein (hsCRP) and Serum Amyloid A Protein (SAA) Levels for Core and 24 Weeks Overall|High sensitivity C-reactive protein (hsCRP) and serum amyloid A (SAA) were determined in blood serum in order to identify the presence of inflammation, to determine its severity, and to monitor the response to treatment. Analytes were measured by a central laboratory. The analysis included treatment group, log-transformed protein level at baseline, and body mass index (BMI) at baseline as covariates.|72 hours post-dose (randomization), 72 hours post-dose for the last post-baseline flare (during 24 weeks overall)|The Full Analysis Set (FAS) consisted of all patients as randomized in core study who had taken at least one dose of study drug. Patients with baseline flare and data at 72 hours post-dose in core and patients with a new flare and data at 72 hours post-dose for the last post-baseline flare (during 24 weeks overall) were included in this analysis.||mg/L||95% Confidence Interval|Least Squares Mean
809097|NCT01029652|Secondary|Percentage of Participants Who Took Rescue Medication|Patients who had difficulty in tolerating their pain were allowed to take rescue medication after the 6-hour post-dose pain assessments. Permitted rescue medications included acetaminophen 500 mg and/ or codeine 30 mg as needed. If they had insufficient pain relief, patients were allowed to take a maximum of 30 mg of oral prednisolone as needed per day for 2 days followed by up to 20 mg of prednisolone as needed per day for 3 subsequent days within 7 days after randomization or after re-dose/injection administration.|during 12 weeks core, 24 weeks overall|"The Full Analysis Set (FAS) consisted of all patients as randomized in core study who had taken at least one dose of study drug. 12 weeks:Core consisted of patients taking rescue medication during baseline flare of Core study and 24 weeks:Overall consisted of patients who took rescue medication during last post-baseline flare during 24 weeks."||Percentage of participants|||Number
809098|NCT01029652|Secondary|Amount of Rescue Medication Taken|"Patients who had difficulty in tolerating their pain were allowed to take rescue medication after the 6-hour post-dose pain assessments as follows:
Acetaminophen (paracetamol) 500 mg and/ or codeine 30 mg as required. A maximum of 1 g/dose or 3 g/day of acetaminophen and 30 mg/ dose or 180 mg/day of codeine was allowed.
If they had insufficient pain relief, patients were allowed to take a maximum of 30 mg of oral prednisolon as required per day for 2 days followed by up to 20 mg of prednisolone as required subsequent days within 7 days of a gout flare."|7 days last post-baseline flare (during 24 weeks)|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. Patients with observations at 7 days last post-baseline flare were included in this analysis.||mg||Standard Deviation|Mean
809099|NCT01029652|Primary|Self-assessed Pain Intensity in the Joint Most Affected at Baseline Measured on a Visual Analog Scale (0-100mm VAS)|Patients scored their pain intensity in the joint most affected at baseline on a 0-100 mm VAS, ranging from no pain (0) to unbearable pain (100), at 72 hours post-dose. Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. The ANCOVA analysis included treatment group, Baseline VAS score, and body mass index (BMI) at Baseline as covariates.|72 hours post-dose (randomization)|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. Last Observation Carried Forward (LOCF) method was used to impute post dose measurement.||mm||Standard Error|Least Squares Mean
809100|NCT01029652|Secondary|Percentage of Participants With Maximum Severity of Last Post-baseline Flare (5-point Likert Scale)|Maximum severity is the maximum Likert score recorded after the start of the flare. Participant scored their current pain intensity in the most affected joint of the gout flare on a 5-point Likert Scale (none, mild, moderate, severe, extreme). It participant had a new flare, they also scored the maximum amount of acute gout pain in the most affected joint since the onset of a new flare on 5 point Likert scale (none, mild, moderate, severe, extreme).|Last post-baseline flare (during 24 weeks overall)|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. Participants with baseline and last post-baseline observations were included in this analysis.||Percentage of participants|||Number
809101|NCT01029652|Secondary|Patient's Assessment of Gout Pain Intensity in the Most Affected Joint on a Visual Analog Scale (VAS) in Extension|Patients scored their pain intensity in the joint most affected at baseline on a 0-100 mm VAS, ranging from no pain (0) to unbearable pain (100). Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. The ANCOVA analysis included treatment group, Baseline VAS score, and body mass index (BMI) at Baseline as covariates.|72 hours post-dose for the last post-baseline flare (during 24 weeks overall)|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. Last Observation Carried Forward (LOCF) method was applied to impute post dose measurements.||mm||Standard Error|Least Squares Mean
809102|NCT01029652|Secondary|Time to First Intake of Rescue Medication After the Last Post Baseline Flare.|The Kaplan-Meier estimates of medians and 95% confidence intervals were used to calculate the endpoint.|72 hours post-dose for the last post-baseline flare (during 24 weeks overall)|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. Patients with observations 72 hours post-dose for the last post-baseline flare during 24 weeks were included in analysis.||Hours||95% Confidence Interval|Median
809103|NCT01029652|Secondary|Mean Number of New Gout Flares Per Patient During the 24 Weeks of the Study|"Patients met definition of new flare if they had:
Flare in joint, not a previously affected joint (at baseline or during study)
Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.
Patients did not meet criterion of having new gout flare if:
· Increasing/renewed gout pain in an affected joint before the flare has resolved completely."|24 weeks|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.||New flares/patient/24 weeks||Standard Deviation|Mean
809104|NCT01029652|Secondary|Time to First New Flare|"Kaplan-Meier (KM) estimates of time to first new flare and confidence intervals were determined. Patients met definition of new flare if they had:
Flare in joint, not a previously affected joint (at baseline or during study)
Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.
Patients did not meet criterion of having new gout flare if:
· Increasing/renewed gout pain in an affected joint before the flare has resolved completely."|24 weeks|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.||Days||95% Confidence Interval|Median
809105|NCT01029652|Secondary|SF36 Physical Function Score at Week 12|The SF-36 measures the impact of disease on overall quality of life (QoL). This 36-item survey has 8 subscales that can be aggregated into physical- and mental-component summary scores. Scores are standardized with the use of norm-based methods based on an assessment of the general U.S. population free of chronic conditions. Scores range from 1-100 with a mean=50 and a standard deviation=10. A higher score indicates less impact on QoL. A negative change score indicates improvement. An ANCOVA model was used with treatment group and baseline SF-36 physical function subscore as covariates.|Week 12|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. Participant observations at Week 12 were included in the analysis.||Units on a scale||Standard Error|Least Squares Mean
809106|NCT01029652|Secondary|Mean Number of New Gout Flares Per Patient|"Patients met definition of new flare if they had:
Flare in joint, not a previously affected joint (at baseline or during study)
Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.
Patients did not meet criterion of having new gout flare if:
· Increasing/renewed gout pain in an affected joint before the flare has resolved completely."|12 weeks|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.||New flares/patient/12 weeks||Standard Deviation|Mean
809107|NCT01029652|Secondary|Percentage of Participants With at Least 1 New Gout Flare During the 12 Weeks|"Patients met definition of new flare if they had:
Flare in joint, not a previously affected joint (at baseline or during study)
Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.
Patients did not meet criterion of having new gout flare if:
· Increasing/renewed gout pain in an affected joint before the flare has resolved completely."|12 weeks|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.||Percentage of participants|||Number
809108|NCT01029652|Secondary|Percentage of Participants With Complete Resolution of Pain|Patients scored their pain intensity on a 5-point Likert scale (none, mild, moderate, severe, extreme). Pain was scored at Baseline; at 6 and 12 hours post-dose; and at 1, 2, 3, 4, 5, 6, and 7 days post-dose. Complete Resolution of Pain is defined as no pain (None) on the Likert Scale. The Kaplan-Meier estimates of cumulative event rate = percentage of participants with event up to the end of the time interval.|7 days post-dose (randomization)|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.||Percentage of participants||95% Confidence Interval|Number
809109|NCT01029652|Secondary|Time to Complete Resolution of Pain|Patients scored their pain intensity on a 5-point Likert scale (none, mild, moderate, severe, extreme). Complete Resolution of Pain is defined as no pain (None) on the Likert Scale. Pain was scored at Baseline; at 6 and 12 hours post-dose; and at 1, 2, 3, 4, 5, 6, and 7 days post-dose. The Kaplan-Meier estimates of time to complete resolution of self-assessed pain intensity in the joint most affected and their confidence intervals were determined.|7 days post-dose (randomization)|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.||Hours||95% Confidence Interval|Median
809110|NCT01029652|Secondary|Time to at Least a 50% Reduction in Self-assessed Pain Intensity in the Joint Most Affected at Baseline Measured on a Visual Analog Scale (0-100mm VAS)|The Kaplan-Meier estimates of the time to at least a 50% reduction in self-assessed pain intensity in the joint most affected at baseline was determined along with the 95% confidence interval. Patients scored their pain intensity on a 0-100 mm VAS, ranging from no pain (0) to unbearable pain (100). Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. Pain was scored at Baseline; at 6 and 12 hours post-dose; and at 1, 2, 3, 4, 5, 6, and 7 days post-dose.|From baseline to 7 days post dose (randomization)|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. Last Observation Carried Forward (LOCF) method was used to impute post dose measurement.||Hours||95% Confidence Interval|Median
809111|NCT01029652|Primary|Time to First New Flare|"Kaplan-Meier estimates of time to first new flare and confidence intervals were determined. For patients with event, time to event = (date of event – date of first dose of study drug + 1).
Patients met definition of new flare if they had:
Flare in joint, not a previously affected joint (at baseline or during study)
Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.
Patients did not meet criterion of having new gout flare if:
· Increasing/renewed gout pain in an affected joint before flare has resolved completely."|12 weeks|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.||Days||95% Confidence Interval|Median
809112|NCT01029704|Secondary|Changes From the Baseline in the Urinary Glucose Excretion at End of 28 Days|Urinary glucose levels were measured at two time points; on day 1 (baseline) and day 28 (end of treatment). Changes in the urinary glucose level during the study period was calculated by reducing the baseline urinary glucose level (day 1) from urinary glucose level at end of treatment (day 28) (i.e urinary glucose level on day 28 minus urinary glucose level on Day 1).|baseline (day 1) and 28 days|||g/24h||Standard Deviation|Mean
823264|NCT01170546|Primary|Isokinetic Strength|Cybex NORM (Cybex International, Inc, Ronkonkoma, New York, U.S.A.) was employed to evaluate isokinetic muscle strength before and after training.|one year||12/2010||||
809113|NCT01029704|Secondary|Changes From the Baseline in the Hemoglobin A1c (HbA1c) at End of 28 Days|HbA1c levels were measured at two time points; on day 1 (baseline) and day 28 (end of treatment). Changes in the HbA1c level during the study period was calculated by reducing the baseline HbA1c level (day 1) from HbA1c level at end of treatment (day 28) (i.e HbA1c level on day 28 minus HbA1c level on Day 1).|baseline (day 1) and 28 days|||Percent||Standard Deviation|Mean
809114|NCT01029704|Secondary|Change From the Baseline in the Body Weight at End of 28 Days|Body weight was measured at two time points; on day 1 (baseline) and day 28 (end of treatment). Changes in the body weight during the study period was calculated by reducing the baseline body weight (day 1) from body weight at end of treatment (day 28) (i.e body weight on day 28 minus body weight on Day 1).|baseline (day 1) and 28 days|||Kg||Standard Deviation|Mean
809115|NCT01029704|Primary|Changes From the Baseline in the Fasting Plasma Glucose at End of 28 Days|Fasting glucose levels were measured at two time points; on day 1 (baseline) and day 28 (end of treatment). Changes in the fasting plasma glucose level during the study period was calculated by reducing the baseline glucose level (day 1) from glucose level at end of treatment (day 28) (i.e glucose level on day 28 minus glucose level on Day 1).|baseline (day 1) and 28 days|||mg/dL||Standard Deviation|Mean
809116|NCT01029730|Secondary|Number of Participants With Adverse Events as a Measure of Safety.|Toxicity grades will be assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0. Includes adverse events occurring in >1 patient|Days 1,8, and 15 of each 28-day cycle for 6 months, then every 3 months for a year, projected 2 years.|All patients||participants|||Number
809117|NCT01029730|Secondary|Median Progression-free Survival|The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|at 3 and 6 months, then every 3 months post-treatment for 1 year and every 6 months thereafter until disease progression; projected 2 years.|||months||95% Confidence Interval|Median
809118|NCT01029730|Secondary|Overall Response Rate|The Percentage of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|At 3 and 6 months during treatment, then 6 months post-treatment.|All patients evaluable for response.||percentage of evaluable participants|||Number
809119|NCT01029730|Primary|Complete Response Rate|Percentage of patients experiencing a complete response (CR) per RECIST. CR = disappearance of all target lesions.|18 months|All evaluable patients||percentage of evaluable participants|||Number
809120|NCT01029795|Secondary|Mean Total Daily Dose of LY2599506 During the 12-week Treatment Period|The average total daily dose (sum of assigned morning and afternoon doses), in milligrams (mg), at each visit. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline through 12 weeks.|No participants had data analyzed due to insufficient sample size.||milligrams (mg)||Standard Deviation|Mean
809121|NCT01029795|Secondary|Percentage of Participants Requiring Dose Adjustments During the 12-week Treatment Period|Percentage of participants who required dose adjustments at the discretion of the investigator for participants with persistent blood glucose<70 milligrams per deciliter (mg/dL). Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline through 12 weeks|Data were reviewed but are not presented due to insufficient sample size.||percentage of participants|||Number
809122|NCT01029795|Secondary|Mean Afternoon Dose of LY2599506 During the 12-week Treatment Period|Assigned afternoon dose, in milligrams (mg), for each participant at each visit. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline, 1, 2, 3, 4, 6, 8, 10, 12 weeks.|Data were reviewed but are not presented due to insufficient sample size.||milligrams (mg)||Standard Deviation|Mean
809123|NCT01029795|Secondary|Mean Morning Dose of LY2599506 During the 12-week Treatment Period|Assigned morning dose, in milligrams (mg), for each participant at each visit. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline, 1, 2, 3, 4, 6, 8, 10, 12 weeks.|Data were reviewed but are not presented due to insufficient sample size.||milligrams (mg)||Standard Deviation|Mean
809124|NCT01029795|Secondary|Change From Baseline in Heart Rate at 12 Weeks and 16 Weeks|Heart rate was measured in heartbeats per minute. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline, 12 weeks, 16 weeks|Data were reviewed but are not presented due to the insufficient sample size.||beats per minute (bpm)||Standard Deviation|Mean
809125|NCT01029795|Secondary|30-day Adjusted Rates of Self-reported Hypoglycemic Episodes Overall|Hypoglycemia: any time a participant experienced a sign/symptom associated with hypoglycemia or had blood glucose <70 milligrams per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]). The 30-day adjusted rate=(total number of episodes between 2 time intervals/number of days between intervals) X 30 days. Study GMAJ was terminated after enrolling 38 participants. Given small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline through 16 weeks|Data were reviewed but are not presented due to insufficient sample size.||hypoglycemic episodes per 30 days|||Number
809636|NCT01044212|Secondary|Pain Level Associated With First Postoperative Bowel Movement|The pain level experienced with the first post-operative bowel movement was recorded and measured on visual analog score with range 0 to 10 in units on scale. 0 being no pain at all. 10 being worst pain.|Within 1 week of surgery|||VAS pain score||Standard Deviation|Mean
809126|NCT01029795|Secondary|Area Under the Concentration-Time Curve (AUC) at a Dosing Interval (AUCtau) at the Steady State for LY2599506|The AUCtau values measure the area under the plasma concentration time curve at a dosing interval at steady state for LY2599506. Due to the nature of sparse sampling approach taken for the study AUC tau was estimated using the posthoc pharmacokinetic (PK) parameters obtained from Population PK (Pop PK) modeling. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Predose and 2 hours after dosing or predose and 4-12 hours after dosing in weeks 1, 2, 3, and 12|Data were reviewed but are not presented due to the insufficient sample size and sparse sampling approach.||nanograms per milliliter times hour||Standard Deviation|Mean
809127|NCT01029795|Secondary|Maximum Plasma Concentration (Cmax) at the Steady State for LY2599506|The Cmax value measures the maximum plasma concentration at steady state following administration of doses of LY2599506. Due to the nature of the sparse sampling approach, Cmax was estimated using the posthoc pharmacokinetic (PK) parameters obtained from Population PK (PopPK) modeling. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Predose and 2 hours after dosing or predose and 4-12 hours after dosing in weeks 1, 2, 3, and 12|Data were reviewed but are not presented due to the insufficient sample size and sparse sampling approach.||nanograms per deciliter (ng/dL)||Standard Deviation|Mean
809128|NCT01029795|Secondary|Percentage of Participants With Clinically-Significant Elevations of Alanine Aminotransferase/Serum Glutamate Pyruvate Transaminase (ALT/SGPT) During the 12-week Treatment Period|Clinically significant elevations of ALT/SGPT were considered ≥3 times the upper limit of normal (ULN). The percentage of participants above 2- and 5-fold ULN was not analyzed due to the early termination of the trial. The percentage of participants with ALT 3-fold ULN or higher is presented.|Baseline through 12 weeks|Only randomized participants with a baseline value and at least 1 post-baseline value of the response variable were included in the analysis.||percentage of participants|||Number
809129|NCT01029795|Secondary|Percentage of Participants With Lipase and Amylase Measurements Above 2-fold Upper Limits of Normal (ULN) During the 12-week Treatment Period|Lipase and amylase concentrations were assessed. Amylase normal limits for males and females are 28-100 units per liter (U/L) (18-50 years), 28-120 U/L (50-60 years), and 28-150 U/L (60-70 years). Normal lipase limits for males and females are 0-100 U/L (18-50 years; 50-60 years) and 0-120 U/L (60-70 years). Study GMAJ was terminated after enrolling only 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline through 12 weeks|Data were reviewed but are not presented due to insufficient sample size.||percentage of participants|||Number
809130|NCT01029795|Secondary|Change From Baseline in the Seven-Point Self-Monitored Blood Glucose (7-point SMBG) at 4 Weeks, 12 Weeks, and 16 Weeks|SMBG levels were measured at the following 7 timepoints during the day: fasting prebreakfast, 2 hours post-breakfast, prior to lunch, 2 hours post-lunch, prior to dinner, 2 hours postdinner, and prior to bed. Study GMAJ was terminated after enrolling only 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline, 4 weeks, 12 weeks, 16 weeks|Data were reviewed but are not presented due to insufficient sample size.||millimoles per liter (mmol/L)||Standard Deviation|Mean
809131|NCT01029795|Secondary|Change From Baseline in Body Weight at 12 Weeks and 16 Weeks|Weight was measured in the fasting state (with the exception of Visit 1) and after emptying the bladder. Participants were instructed to be lightly clothed and without shoes. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline, 12 weeks, 16 weeks|Data were reviewed but are not presented due to insufficient sample size.||kilograms (kg)||Standard Deviation|Mean
809132|NCT01029795|Secondary|Number of Hypoglycemic Episodes During 12-week Treatment Period and 4-week Follow-up Period|Hypoglycemia was defined as any time a participant felt s/he was experiencing a sign or symptom associated with hypoglycemia or had a blood glucose <70 milligrams per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]) even if it was not associated with signs or symptoms of hypoglycemia. Study GMAJ was terminated after enrolling only 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline through 16 weeks|Data were reviewed but are not presented due to insufficient sample size.||hypoglycemic episodes|||Number
809133|NCT01029795|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at 12 Weeks and 16 Weeks|Change in SBP and DBP following 12 weeks of therapy (Week 12 SBP minus SBP at baseline; Week 12 DBP minus DBP at baseline) and 16 weeks of therapy (Week 16 SBP minus SBP at baseline; Week 16 DBP minus DBP at baseline). Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline, 12 weeks, 16 weeks|Data were reviewed but are not presented due to insufficient sample size.||mm Hg||Standard Deviation|Mean
809134|NCT01029795|Secondary|Change From Baseline in the Perceptions About Medications – Diabetes (PAM-D) Questionnaire at 12 Weeks and 16 Weeks|"PAM-D assesses participants' perceptions about their diabetes medications during the past month. Responses ranged from None of the time, to All of the time. The sum of all items in the scale equals the scale score, which was linearly transformed to a 0 (least favorable state) to 100 (most favorable state). Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed."|Baseline, 12 weeks, 16 weeks|Quality of life data were not analyzed due to insufficient sample size.||units on a scale||Standard Deviation|Mean
809637|NCT01044212|Primary|Time to First Post-op Bowel Movement|The time to first post-operative bowel movement was measured in hours after surgery.|Within 1 week of surgery|Power analysis||hours||Standard Deviation|Mean
809135|NCT01029795|Secondary|Changes From Baseline in the Diabetes Symptoms Checklist-Revised (DSC-R) at 12 Weeks and 16 Weeks|Comprise 6 subscales (34 items). Each item score: 1 (not troublesome) to 5 (extremely troublesome) and transformed to 0-4 scale. Subscale score=sum of item scale in each subscale/total number of items. Global score=sum of scores by dimension. All scores standardized (0-100). Higher scores=greater symptom burden. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline, 12 weeks, 16 weeks|Quality of life data were not analyzed due to insufficient sample size.||units on a scale||Standard Deviation|Mean
809136|NCT01029795|Secondary|Change From Baseline in the Adult Low Blood Sugar Survey (LBSS-33 Item Scale) at 12 Weeks and 16 Weeks|Assesses 2 hypoglycemia domains, with each item score from 0 (never engages in behavior) to 4 (always engages in behavior): Behavioral (15 items; range 0-60) and Worry about hypoglycemia (18 items; range 0-72). Total score is the sum of both domains (range 0-132). Higher scores indicate greater negative impact. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall, and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading. As a result, this outcome measure was not analyzed.|Baseline, 12 weeks, 16 weeks|Quality of life data were not analyzed due to insufficient sample size.||units on a scale||Standard Deviation|Mean
809137|NCT01029795|Secondary|Change From Baseline in the Diabetes Treatment Satisfaction Questionnaire (DTSQ) at 12 Weeks and 16 Weeks|DTSQ, an 8-item questionnaire, measures satisfaction with treatment, perceived frequency of hyperglycemia, and perceived frequency of hypoglycemia. Response options range from 6 (best case) to 0 (worst case). Total scores for treatment satisfaction range from 0-36. Higher scores indicate higher satisfaction. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline, 12 weeks, 16 weeks|Quality of life data were not analyzed due to insufficient sample size.||units on a scale||Standard Deviation|Mean
809138|NCT01029795|Secondary|Change From Baseline in the European Quality of Life -5 Dimension (EQ-5D) at 12 Weeks and 16 Weeks|Assesses 5 health domains: mobility, self-care, usual activity, pain, and anxiety/depression with 3 options each. Total scores range from 5 (no problem) to 15 (more severe or frequent problems). An algorithm maps the 5 domain outcomes to a single index (0-1). A higher score indicates better perceived health state. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline, 12 weeks, 16 weeks|Quality of life data were not analyzed due to insufficient sample size.||units on a scale||Standard Deviation|Mean
809139|NCT01029795|Secondary|Change From Baseline in Triglycerides, Low-density Lipoprotein Cholesterol (LDL-C), High-density Lipoprotein Cholesterol (HDL-C), Non-HDL-C, Total Cholesterol, and Free Fatty Acids at 12 Weeks and 16 Weeks|Fasting lipids were measured after an overnight fast. Lipids measured included triglycerides, HDL-C, LDL-C, non-HDL-C, total cholesterol, and free fatty acids. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline, 12 weeks, 16 weeks|Data were reviewed but not presented due to insufficient sample size.||millimoles per liter (mmol/L)||Standard Deviation|Mean
809140|NCT01029795|Secondary|Change From Baseline in the Homeostasis Model Assessment (HOMA2) of Insulin Sensitivity (%S) at 12 Weeks and 16 Weeks|HOMA2 is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S), as percentages of a normal reference population (normal young adults). The normal reference population was set at 100%. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not calculated or analyzed.|Baseline, 12 weeks, 16 weeks|HOMA2 (%S) was not calculated due to insufficient sample size.||percentage of insulin sensitivity (%S)||Standard Deviation|Mean
809141|NCT01029795|Secondary|Change From Baseline in the Homeostasis Model Assessment (HOMA2) Pancreatic Beta Cell Function (%B) at 12 Weeks and 16 Weeks|HOMA2 is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state pancreatic beta cell function (%B) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not calculated or analyzed.|Baseline, 12 weeks, 16 weeks|HOMA2 (%B) was not calculated due to insufficient sample size.||percentage of beta cell function (%B)||Standard Deviation|Mean
809142|NCT01029795|Secondary|Change From Baseline in the QT Interval in Electrocardiogram (ECG) at 12 Weeks and 16 Weeks|Measures the QT interval in the ECG. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline, 12 weeks, 16 weeks|The QT interval was not analyzed due to insufficient sample size.||milliseconds (ms)||Standard Deviation|Mean
809143|NCT01029795|Primary|Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at 12 Weeks|Change in HbA1c from baseline following 12 weeks of therapy (HbA1c at week 12 minus HbA1c at baseline). Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline, 12 weeks|Data were reviewed but are not presented due to insufficient sample size.||percentage of glycosylated hemoglobin||Standard Deviation|Mean
809190|NCT01030822|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life- threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity.|After the first vaccination up to study end (from Month 0 to Month 15)|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine dose administration documented.||Subjects|||Number
809144|NCT01029886|Secondary|Assessment of Event Rate of Treatment-emergent Hypoglycemic Events|Major hypoglycemia: any episode with symptoms consistent with hypoglycemia that resulted in loss of consciousness or seizure with prompt recovery in response to administration of glucagon or glucose OR documented hypoglycemia (blood glucose <3.0 mmol/L [54 mg/dL]) and required the assistance of another person. Minor hypoglycemia: any sign or symptom associated with hypoglycemia that is either self-treated by the patient or resolves on its own AND has a concurrent finger stick blood glucose <3.0 mmol/L (54 mg/dL) and not classified as major hypoglycemia. Event rate per subject year was calculated for each subject: (number of events observed from a subject/exposure from a subject)*365.25 where exposure = last post-baseline visit date - baseline visit date. Mean and Standard Error were then derived from ITT.|Baseline to Week 26|ITT Population.||events per subject-year||Standard Error|Mean
809145|NCT01029886|Secondary|Change in Diastolic Blood Pressure (DBP) From Baseline to Week 26|Change in DBP from baseline to the treatment endpoint at Week 26.|Baseline, Week 26|ITT Population. All observed data from all scheduled visits (including early termination visits) were included in the MMRM analysis. Data collected at the early termination visits were mapped into the following scheduled visits.||mmHg||Standard Error|Least Squares Mean
809146|NCT01029886|Secondary|Change in Systolic Blood Pressure (SBP) From Baseline to Week 26|Change in SBP from baseline to the treatment endpoint at Week 26.|Baseline, Week 26|ITT Population. All observed data from all scheduled visits (including early termination visits) were included in the MMRM analysis. Data collected at the early termination visits were mapped into the following scheduled visits.||mmHg||Standard Error|Least Squares Mean
809147|NCT01029886|Secondary|Ratio of Fasting Triglycerides at Week 26 to Baseline|Ratio of fasting triglycerides (measured in mmol/L) treatment endpoint at Week 26 to baseline. Log(Postbaseline fasting triglycerides) - log(Baseline fasting triglycerides); change from baseline to the treatment endpoint at Week 26 is presented as ratio of Week 26 to baseline.|Baseline, Week 26|ITT Population. All observed data from all scheduled visits (including early termination visits) were included in the MMRM analysis. Data collected at the early termination visits were mapped into the following scheduled visits.||ratio||Standard Error|Least Squares Mean
809148|NCT01029886|Secondary|Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26|Change in HDL-C from baseline to the treatment endpoint at Week 26.|Baseline, Week 26|ITT Population. All observed data from all scheduled visits (including early termination visits) were included in the MMRM analysis. Data collected at the early termination visits were mapped into the following scheduled visits.||mmol/L||Standard Error|Least Squares Mean
809149|NCT01029886|Secondary|Change in Total Cholesterol From Baseline to Week 26|Change in total cholesterol from baseline to the treatment endpoint at Week 26.|Baseline, Week 26|ITT Population. All observed data from all scheduled visits (including early termination visits) were included in the MMRM analysis. Data collected at the early termination visits were mapped into the following scheduled visits.||mmol/L||Standard Error|Least Squares Mean
809150|NCT01029886|Secondary|Change in Body Weight From Baseline to Week 26|Change in body weight from baseline to the treatment endpoint at Week 26.|Baseline, Week 26|ITT Population. All observed data from all scheduled visits (including early termination visits) were included in the MMRM analysis. Data collected at the early termination visits were mapped into the following scheduled visits.||kg||Standard Error|Least Squares Mean
809151|NCT01029886|Secondary|Change in Fasting Serum Glucose From Baseline to Week 26|Change in fasting serum glucose from baseline to the treatment endpoint at Week 26.|Baseline, Week 26|ITT Population. All observed data from all scheduled visits (including early termination visits) were included in the MMRM analysis. Data collected at the early termination visits were mapped into the following scheduled visits.||mmol/L||Standard Error|Least Squares Mean
809152|NCT01029886|Secondary|Percentage of Patients Achieving HbA1c <7.0% at Week 26|Percentage of patients achieving HbA1c <7.0% at treatment endpoint at Week 26.|Baseline, Week 26|ITT Population. Missing data at endpoint was imputed using last observation carried forward approach.||percentage of patients|||Number
809153|NCT01029886|Primary|Change in HbA1c From Baseline to Week 26|Change in HbA1c from baseline to the treatment endpoint at Week 26.|Baseline, Week 26|ITT Population: all patients who were randomized and received study drug. All observed data from all scheduled visits (including early termination visits) were included in the mixed-model repeated measures (MMRM) analysis. Data collected at the early termination visits were mapped into the following scheduled visits.||percentage of total hemoglobin||Standard Error|Least Squares Mean
809154|NCT01029925|Primary|Response Rate by RECIST Criteria of Oral Dichloroacetate in Patients With Recurrent and/or Metastatic and Pretreated Breast and Non-small Cell Lung Cancer.|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|upto 72 days|Intent to treat analysis was performed. Zero patients achieved complete or partial response in this study.||participants|||Number
809155|NCT01030458|Secondary|Proportion of Patients Reaching Blood Pressure Control at the End of Follow-up|This variable gives the proportion of patients reaching blood pressure control over time (< 140 mmHg systolic and < 90 mmHg diastolic)|6 months follow-up after randomization|||participants|||Number
809156|NCT01030458|Secondary|Side-effects to Study Medications||6 months follow-up after randomization|||participants|||Number
809157|NCT01030458|Secondary|Time to Blood Pressure Control|The time (in weeks) after randomisation that will be required to reach and maintain the target, defined as a blood pressure below 140 mmHg systolic and 90 mmHg diastolic.|6 months follow-up after randomization|||weeks||Inter-Quartile Range|Median
809158|NCT01030458|Primary|Sitting Systolic Blood Pressure on Automated Measurement|Blood pressure is measured by means of validated oscillometric OMRON 705IT recorders (OMRON Healthcare Europe BV, Nieuwegein, Netherlands), after the patient has been seated for 5 minutes in a quiet room, according to the ESC/ESH guidelines. Three consecutive blood pressure readings are obtained and the average of these 3 measurements is used as the primary outcome.|6 months follow-up after randomization|The main analysis included all randomised patients with at least one follow-up visit, according to the intention-to-treat principle.||mmHg||Standard Deviation|Mean
809159|NCT01030653|Secondary|The Area Under the Curve Over the Dosing Interval for All Participants While on the High Dose and Low Dose Interventions.||12 hours|||hour*milligram/Liter||95% Confidence Interval|Geometric Mean
823265|NCT01170546|Primary|Agility|shuttle run agility test|one year||12/2010||||
809160|NCT01030653|Primary|Geometric Mean Ratio of the AUC Between the High and Low Dose Voriconazole|AUC is the area under the concentration-time curve. The Geometric Mean Ratio and 90% confidence interval around this value permit an assessment of the bioequivalence of two dosing regimens in the same group. The geometric mean is computed based on the ratio of the AUC value from the high dose compared to the AUC value from the low dose for each individual. This ratio provides a more robust interpretation of the differences between the two dosing arms because each individual serves as their own control.|14 days|This is a comparison of the same group analyzed through a cross-over design of two voriconazole dosing regimens||Ratio||90% Confidence Interval|Number
809161|NCT01030653|Primary|Steady-State Cmax and Cmin of Two Voriconazole Dosing Regimens|"Cmax is the maximum concentration, and Cmin is the minimum concentration. These measurements are based on analysis of plasma. The units shown are milligrams of voriconazole per liter of plasma. The two dosing regimens are:
a loading dose (400 mg x 2 doses, day 1) and maintenance doses (200 mg every 12 hours x 7 doses) in obese subjects.
a loading dose (400 mg x 2 doses, day 1) and maintenance doses (300 mg every 12 hours x 7 doses) in obese subjects."|Day 5|The same subjects were analyzed in a cross-over design at two dose levels||mg/L||95% Confidence Interval|Mean
809162|NCT01030666|Secondary|Radiographic Bony Fill 12 Months After Surgery (Reduction of Distance Cemento-enamel Junction [CEJ] to Bony Defect [BD])|If the CEJ was destroyed by the restorative treatment the margin of the restoration was taken as landmark. BD is defined as most coronal point where the periodontal ligament space shows a continuous width. If no periodontal ligament space could be identified, the point where the projection of the alveolar crest (AC) crossed the root surface was taken as a landmark. If both structures could be identified at one defect, the point defined by the periodontal ligament was used as BD and the crossing of the silhouette of the alveolar crest with the root surface was defined as AC. If several bony contours could be identified, the most apical one that crossed the root was defined as the BD and the most coronal one as AC.|Baseline to 12 months after surgery|ITT population. Missing data due to losing to follow-up: last observation carried forward. Patients whose radiographs could not be analysed were excluded.||mm||Standard Deviation|Mean
809163|NCT01030666|Primary|Vertical Clinical Attachment (PAL-V) Gain 6 Months After Surgery|Difference of PAL-V measurement at baseline and 6 months. PAL-V were measured to the nearest 0.5 mm using a straight manual periodontal probe (PCPUNC 15, Hu Friedy, Chicago, IL, USA). As reference for the PAL-V measurements, the cemento-enamel junction (CEJ) was used. If the CEJ is destroyed by a restoration (filling, crown) the margin of this restoration served as reference.|Baseline to 6 months after surgery|per protocol analysis: all participants who attended the 6 months re-examination||mm||Standard Deviation|Mean
809164|NCT01030718|Secondary|Collection of Blood Samples for Pharmacokinetic Analysis of Dasatinib Twice Daily (BID) That Will Contribute to Population Pharmacokinetic Modeling|Blood samples for pharmacokinetic analysis of Dasatinib BID that will contribute to population pharmacokinetic modeling were collected.|At any visit of later than Day 7, draw sample(s) at pretreatment trough (within 1 hour prior to dosing) or between 3 hours following treatment and prior to the next dose|There was no individual PK analysis done for this study; analyses were integrated and evaluated as a part of population PK of this drug.||participants|||Number
809165|NCT01030718|Secondary|Status of Point Mutations of BCR-ABL at Baseline (BL) and End of Study (EOS)|Point mutations of BCR-ABL detected or undetected in the Quantitative real-time PCR polymerase chain reaction (RQ-PCR) products|At baseline and discontinuation--the study period was extended until the launch of dasatinib in Japan, January 2009.|Treated participants||participants|||Number
809166|NCT01030718|Secondary|Participants With Detectable Mutations of RNA (mRNA) of BCR-ABL at Baseline and at Best Achievement|Detectable BCR-ABL transcripts (b3a2, b2a2 or minor) >=2.0 log copy/micrograms RNA, as measured by real-time quantitative PCR (RQ-PCR) at baseline and best achievement post-dose.|At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter, and at discontinuation|Treated participants||participants|||Number
809167|NCT01030718|Secondary|Duration of Overall Hematologic Response (OHR) in Accelerated or Blast Phase CML, and Ph+ALL|The overall hematologic response (OHR) rate is defined as the proportion of all treated subjects with a best response of major or minor hematologic response. Subjects who neither progressed nor died were censored on the date of last hematologic assessment.|baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454); every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation|Duration of OHR was computed only for participants whose best response was CHR or a MaHR or MiHR & was measured from the first day hematologic response criteria were met, provided they were confirmed 28 days later until the date of PD or death. Median duration of OHR in the CML-AP/BP arm was not yet reached.||Days||Full Range|Median
809168|NCT01030718|Secondary|Time to Overall Hematologic Response (OHR) in Accelerated or Blast Phase CML, and Ph+ALL|The overall hematologic response (OHR) rate is defined as the proportion of all treated subjects with a best response of major or minor hematologic response. Time to OHR = time from first dose of dasatinib until the first day measurement criteria are first met for hematologic response provided they were confirmed 28 days later. Subjects who neither progressed nor died were censored on the date of last hematologic assessment.|baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454); every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation|OHR was computed only for subjects whose best response is CHR or MaHR or Minor HR (MiHR).||Days||Full Range|Median
809169|NCT01030718|Secondary|Duration of Major Hematologic Response (MaHR) in Accelerated or Blast Phase CML, and Ph+ALL|Major Hematologic Response (MaHR)=Complete Hematologic Response (CHR) or No Evidence of Leukemia (NEL; see Outcome Measures 14 and 15 for full definitions). Subjects who neither progressed nor died were censored on the date of their last hematologic assessment.|baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454); every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation|Duration of MaHR was computed only for advanced diseases subjects whose best response is a MaHR and was measured from the first day MaHR criteria are met, provided they were confirmed 28 days later until the date of PD or death. Median Duration of MaHR was not yet reached in the CML-AP/BP arm.||Days||Full Range|Median
809467|NCT01040403|Secondary|FEV1 Peak 0-3h Response|Adjusted means of the FEV1 peak value over the time from 0 to 3 hours (peak 0-3h) response [L] after 4 weeks of treatment. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.|Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 29|FAS||Litres||Standard Error|Mean
809170|NCT01030718|Secondary|Time to Major Hematologic Response (MaHR) in Accelerated or Blast Phase CML, and Ph+ALL|Major Hematologic Response=Complete Hematologic Response (CHR) or No Evidence of Leukemia (NEL; see Outcome Measures 14 and 15 for full definitions). Time to major hematologic response (MaHR)=time from first dose of dasatinib until the first day the measurement criteria for MaHR and is computed only for advanced diseases subjects whose best response is a major hematologic response. Subjects who neither progressed nor died were censored on the date of their last hematologic assessment.|baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454); every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation|Participants achieving MaHR||Days||Full Range|Median
809171|NCT01030718|Secondary|Duration of Complete Hematologic Response (CHR) in Chronic Phase CML, Accelerated or Blast Phase CML, and Ph+ALL|Duration of CHR was computed only for chronic phase CML subjects whose best response is CHR. It was measured from the first day complete hematologic response criteria are met provided they are confirmed 28 days later until the date treatment is discontinued due to PD or death. Subjects who neither progressed nor died were censored on the date of their last hematologic assessment.|baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454); every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation|Participants achieving CHR. Duration of CHR in the CML AP/BP arm has not yet been reached.||Days||Full Range|Median
809172|NCT01030718|Secondary|Time to Complete Hematologic Response (CHR) in Chronic Phase CML, Accelerated or Blast Phase CML, and Ph+ALL|CHR=all of the following criteria: WBC ≤institutional upper limit of normal(ULN); platelets <450,000/mm³; no blasts or promyelocytes in peripheral blood; <5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils <20%; no extramedullary involvement. Time to CHR=time from first dose of dasatinib until the first day criteria for CHR are met provided they are confirmed 28 days later and was computed only for chronic phase CML subjects whose best response is CHR. Subjects who neither progressed nor died were censored at date of last hematologic assessment.|baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454); every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation|Participants achieving CHR||Days||Full Range|Median
809173|NCT01030718|Secondary|Participants With Ph+ ALL: Percentage of Participants With Hematologic Response|Major Hematologic Response=Complete Hematologic Response (CHR) or No Evidence of Leukemia (NEL). CHR=(see Outcome Measure 14, above). NEL=WBC ≤ULN; BM blasts ≤5%; no blasts or promyelocytes in peripheral blood; <5% myelocytes plus metamyelocytes in peripheral blood; <20% peripheral blood basophils; no extramedullary involvement; and at least 1 of the following: ANC ≥500/mm3 and <2000/mm3 or platelets ≥20,000/mm3 and <100,000/mm3. Overall hematologic response (OHR)=best response of CHR, NEL or return to chronic phase (RTC).|baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454); every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation|Treated Ph+ ALL participants||Percentage of Participants||95% Confidence Interval|Number
809174|NCT01030718|Secondary|Participants With CML-AP/BP: Percentage of Participants With Hematologic Response|Major Hematologic Response=Complete Hematologic Response (CHR) or No Evidence of Leukemia (NEL). CHR=WBC <ULN; absolute neutrophil count (ANC) >1,000/mm3; platelets >100,000/mm3; no blasts or promyelocytes in peripheral blood; BM blasts ≤5%; <5% myelocytes + metamyelocytes in peripheral blood; <20% basophils in peripheral blood; no extramedullary involvement. NEL=(see Outcome Measure 15, below). Overall hematologic response (OHR)=best response of CHR, NEL or return to chronic phase (RTC).|baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454); every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation|Treated CML-AP/BP participants||Percentage of Participants||95% Confidence Interval|Number
809175|NCT01030718|Secondary|Participants With CML-CP: Percentage of Participants With Complete Hematologic Response (CHR)|CHR=all of the following criteria: white blood cell count (WBC) ≤institutional upper limit of normal(ULN); platelets <450,000/mm³; no blasts or promyelocytes in peripheral blood; <5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils <20%; no extramedullary involvement.|baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454), every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation|Treated CML-CP participants||Percentage of Participants||95% Confidence Interval|Number
809176|NCT01030718|Secondary|Participants With CML-AP/BP and Ph+ ALL: Duration of Major Cytogenetic Response (MCyR)|Major Cytogenetic Response (MCyR) = Complete Cytogenetic Response (CCyR; 0 Ph+ Cells in Metaphase in BM), plus Partial Cytogenetic Response (PCyR; 1 - 35 Ph+ Cells in Metaphase in BM). Duration of MCyR was measured from the time measurement criteria are first met for CCyR or PCyR (whichever status is recorded first) until the first date of progressive disease (PD) or death. Subjects who neither relapsed nor died were censored on the date of their last assessment.|At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter|Duration of MCyR was computed for subjects whose best response was either CCyR or PCyR. Median duration of MCyR was not yet reached in the CML-AP/BP arm.||Days||Full Range|Median
809177|NCT01030718|Secondary|Participants With CML-CP: Duration of Major Cytogenetic Response (MCyR)|Major Cytogenetic Response (MCyR) = Complete Cytogenetic Response (CCyR; 0 Ph+ Cells in Metaphase in BM), plus Partial Cytogenetic Response (PCyR; 1 - 35 Ph+ Cells in Metaphase in BM). Duration of MCyR was measured from the time measurement criteria are first met for CCyR or PCyR (whichever status is recorded first) until the first date of progressive disease (PD) or death. Subjects who neither relapsed nor died were censored on the date of their last assessment.|At baseline, every 24 weeks thereafter (including study CA180031/NCT00337454)|Duration of MCyR was computed for subjects whose best response was either CCyR or PCyR. Median duration of MCyR was not yet reached in the CML-CP arm.||Days||Full Range|Median
809178|NCT01030718|Secondary|Participants With CML-AP/BP and Ph+ALL: Time to Major Cytogenetic Response (MCyR)|Major Cytogenetic Response (MCyR) = Complete Cytogenetic Response (CCyR; 0 Ph+ Cells in Metaphase in BM), plus Partial Cytogenetic Response (PCyR; 1 - 35 Ph+ Cells in Metaphase in BM). Time to MCyR was defined as the time from first dose of dasatinib until measurement criteria were first met for CCyR or PCyR (whichever status is recorded first).|At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter|Time to MCyR was computed only for participants whose best response was CCyR or PCyR.||Days||Full Range|Median
809481|NCT01041976|Primary|Participation in Vocational Rehabilitation Services|"Yes/No: Did veteran complete an intake for a VA Supported Employment program at any time from randomization to 18 month follow-up.
Outcome: Number of participants who completed an intake for VA Supported Employment program at any time from randomization to 18 month follow-up."|18 months|||participants|||Number
809179|NCT01030718|Secondary|Participants With CML-CP: Time to Major Cytogenetic Response (MCyR)|Major Cytogenetic Response (MCyR) = Complete Cytogenetic Response (CCyR; 0 Ph+ Cells in Metaphase in BM), plus Partial Cytogenetic Response (PCyR; 1 - 35 Ph+ Cells in Metaphase in BM). Time to MCyR was defined as the time from first dose of dasatinib until measurement criteria were first met for CCyR or PCyR (whichever status is recorded first).|At baseline, every 24 weeks thereafter (including study CA180031/NCT00337454)|Time to MCyR was computed only for participants whose best response was CCyR or PCyR.||Days||Full Range|Median
809180|NCT01030718|Secondary|Participants With CML-AP/BP and Ph+ALL: Duration of Complete Cytogenetic Response (CCyR)|Cytogenetic responses (CyR) are based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each bone marrow (BM) sample. Complete Cytogenetic Response (CCyR) = 0 Ph+ Cells in Metaphase in BM. Duration of CCyR was measured from the time measurement criteria are first met for CCyR until the first date of PD or death. Subjects who neither relapsed nor died will be censored on the date of their last assessment.|At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter|Participants achieving CCyR. Median duration of CCyR was not yet reached in the CML-AP/BP group.||Days||Full Range|Median
809181|NCT01030718|Secondary|Participants With CML-CP: Duration of Complete Cytogenetic Response (CCyR)|Cytogenetic responses (CyR) are based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each bone marrow (BM) sample. Complete Cytogenetic Response (CCyR) = 0 Ph+ Cells in Metaphase in BM. Duration of CCyR was measured from the time measurement criteria are first met for CCyR until the first date of progressed disease (PD) or death. Subjects who neither relapsed nor died will be censored on the date of their last assessment.|At baseline, every 24 weeks thereafter (including study CA180031/NCT00337454)|Participants achieving CCyR. Median duration of CCyR was not yet reached in the CML-CP group.||Days||Full Range|Median
809182|NCT01030718|Secondary|Participants With CML-AP/BP and Ph+ ALL: Time to Complete Cytogenetic Response (CCyR)|Cytogenetic responses (CyR) are based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each bone marrow (BM) sample. Complete Cytogenetic Response (CCyR) = 0 Ph+ Cells in Metaphase in BM. Time to complete CCyR is defined as the time from first dose of dasatinib until measurement criteria are first met for CCyR, and is computed only for subjects whose best response is CCyR.|At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter|Participants achieving CCyR||Days||Full Range|Median
809183|NCT01030718|Secondary|Participants With CML-CP: Time to Complete Cytogenetic Response (CCyR)|Cytogenetic responses (CyR) are based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each bone marrow (BM) sample. Complete Cytogenetic Response (CCyR) = 0 Ph+ Cells in Metaphase in BM. Time to complete CCyR is defined as the time from first dose of dasatinib until measurement criteria are first met for CCyR, and is computed only for subjects whose best response is CCyR.|At baseline, every 24 weeks thereafter (including study CA180031/NCT00337454),|Participants achieving CCyR||Days||Full Range|Median
809184|NCT01030718|Secondary|Participants With Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL): Percentage of Participants With Cytogenetic Response|Cytogenetic responses (CyR) are based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each bone marrow (BM) sample. The criteria for cytogenetic responses are as follows. Best CyR is defined as the best response obtained at any time during the study. Major Cytogenetic Response (MCyR) = Complete Cytogenetic Response (CCyR; 0 Ph+ Cells in Metaphase in BM), plus Partial Cytogenetic Response (PCyR; 1 - 35 Ph+ Cells in Metaphase in BM).|At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter|Treated Ph+ ALL participants||Percentage of Participants||95% Confidence Interval|Number
809185|NCT01030718|Secondary|Participants With CML-Accelerated or Blast Phase (AP/BP): Percentage of Participants With Cytogenetic Response|Cytogenetic responses (CyR) are based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each bone marrow (BM) sample. The criteria for cytogenetic responses are as follows. Best CyR is defined as the best response obtained at any time during the study. Major Cytogenetic Response (MCyR) = Complete Cytogenetic Response (CCyR; 0 Ph+ Cells in Metaphase in BM), plus Partial Cytogenetic Response (PCyR; 1 - 35 Ph+ Cells in Metaphase in BM).|At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter|Treated CML-AP/BP participants||Percentage of Participants||95% Confidence Interval|Number
809186|NCT01030718|Secondary|Participants With Chronic Phase CML (CML-CP): Percentage of Participants With Cytogenetic Response|Cytogenetic responses (CyR) are based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each bone marrow (BM) sample. The criteria for cytogenetic responses are as follows. Best CyR is defined as the best response obtained at any time during the study. Major Cytogenetic Response (MCyR) = Complete Cytogenetic Response (CCyR; 0 Ph+ Cells in Metaphase in BM), plus Partial Cytogenetic Response (PCyR; 1 - 35 Philadelphia positive [Ph+] Cells in Metaphase in BM).|At baseline, every 24 weeks thereafter (including study CA180031/NCT00337454)|Treated CML-CP participants||Percentage of Participants||95% Confidence Interval|Number
809187|NCT01030718|Primary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuation|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|baseline; every 4 weeks (if on study < 6 months, including CA180-031(NCT00337454); every 12 weeks (if on study >=6 months and <=2 years); every 24 weeks (if on study >2 years); at discontinuation|All treated participants. Number of deaths represents all reported deaths, including after the study end. For AEs leading to discontinuation: 4 in CML-CP=1 insufficient effect (IE) +3 AEs in Participant Flow (PF); 7 in CML-AP/BP= 1 death + 5 AEs + 1 IE in PF; 4 in Ph+ALL=3 IE + 1AE in PF.||participants|||Number
809188|NCT01030757|Secondary|Toxicity, Progression Free Survival, Clinical Benefit Rate (Complete Response + Partial Response + Stable Disease), Median Duration of Clinical Benefit, and Median Overall Survival of Subjects.||1 year|Study was terminated due to low accrual; no results to report.|||||
809189|NCT01030757|Primary|Tumor Response Rate (Complete Response + Partial Response).||1 year|Study was terminated due to low accrual; no results to report|||||
809191|NCT01030822|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within 31-day follow-up period (Days 0-30) after vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine dose administration documented.||Subjects|||Number
809192|NCT01030822|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were Drowsiness, Irritability/Fussiness (Irr./Fuss.), Loss of appetite (Loss Appet.) and Fever (rectal temperature higher than [≥] 38.0 degrees Celsius [°C]),. Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal everyday activities. Grade 3 Irr./Fuss. = Crying that could not be comforted/prevented normal everyday activities. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = Rectal temperature higher than (>) 40.0°C.|Within the 4-day follow-up period (Days 0-3) after the booster dose for the Synflorix 1 and Synflorix 2 Groups and across doses for the Tritanrix-HepB + Hiberix Group|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine dose administration documented and with the symptom sheet filled in.||Subjects|||Number
809193|NCT01030822|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (>) 30 millimeters (mm). “Any” is defined as incidence of the specified symptom regardless of intensity.|Within the 4-day follow-up period (Days 0-3) after the booster dose for the Synflorix 1 and Synflorix 2 Groups and across doses for the Tritanrix-HepB + Hiberix Group|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine dose administration documented and with the symptom sheet filled in.||Subjects|||Number
809194|NCT01030822|Secondary|Concentrations of Antibodies Against Protein D (Anti-PD)|Anti-protein D (Anti-PD) antibody concentrations by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 100 EL.U/mL. Antibody concentrations < 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|Prior to vaccination (PRE), one month post-Dose 2 (Month 3), prior to (Month 6) and one month after the third (booster) vaccine dose (Month 7)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at the requested time points.||EL.U/mL||95% Confidence Interval|Geometric Mean
809195|NCT01030822|Secondary|Concentrations of Antibodies Against Protein D (Anti-PD)|Anti-protein D (Anti-PD) antibody concentrations by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 100 EL.U/mL. Antibody concentrations < 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|Prior to booster vaccination (PRE), one month after booster vaccination (Month 1) and at approximately 24 months of age: at Month 15 for the Synflorix 1 Group and at Month 9 for the Synflorix 2 Group (24 months of age)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at the requested time points.||EL.U/mL||95% Confidence Interval|Geometric Mean
809196|NCT01030822|Secondary|Concentrations of Antibodies Against Protein D (Anti-PD) (Persistence)|Anti-protein D (Anti-PD) antibody concentrations by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 100 EL.U/mL. Antibody concentrations < 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|Prior to booster vaccination (PRE) for the Synflorix 1 and Synflorix 2 Groups and prior to catch-up vaccination (PRE) for the Tritanrix-HepB + Hiberix Group|The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom assay results for antibodies against at least one pneumococcal serotype were available before the administration of the booster dose of the Synflorix™ vaccine.||EL.U/mL||95% Confidence Interval|Geometric Mean
809197|NCT01030822|Secondary|Opsonophagocytic Activity (OPA) Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A|OPA titers against cross-reactive pneumococcal serotypes 6A and 19A (Opsono-6A and -19A) were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seropositivity cut-off for the assay was ≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.|Prior to vaccination (PRE), one month post-Dose 2 (Month 3), prior to (Month 6) and one month after the third (booster) vaccine dose (Month 7)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at the requested time points.||Titer||95% Confidence Interval|Geometric Mean
809198|NCT01030822|Secondary|Opsonophagocytic Activity (OPA) Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A|OPA titers against cross-reactive pneumococcal serotypes 6A and 19A (Opsono-6A and -19A) were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seropositivity cut-off for the assay was ≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.|Prior to booster vaccination (PRE), one month after booster vaccination (Month 1) and at approximately 24 months of age: at Month 15 for the Synflorix 1 Group and at Month 9 for the Synflorix 2 Group (24 months of age)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at the requested time points.||Titer||95% Confidence Interval|Geometric Mean
809215|NCT01030952|Secondary|Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)|change in LDL-C at 0, 30 and 120 minutes|baseline, 3 weeks (end of study)|Intent to Treat population - All patients who received at least one dose of study drug after random allocation and had at least one primary or secondary efficacy evaluation after baseline. During different time points, participants with observations at that time point were included in the analysis.||millimoles per litre (mmol/l)||Standard Deviation|Mean
809199|NCT01030822|Secondary|Opsonophagocytic Activity (OPA) Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Persistence)|OPA titers against cross-reactive pneumococcal serotypes 6A and 19A (Opsono-6A and -19A) were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seropositivity cut-off for the assay was ≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.|Prior to booster vaccination (PRE) for the Synflorix 1 and Synflorix 2 Groups and prior to catch-up vaccination (PRE) for the Tritanrix-HepB + Hiberix Group|The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom assay results for antibodies against at least one pneumococcal serotype were available before the administration of the booster dose of the Synflorix™ vaccine.||Titer||95% Confidence Interval|Geometric Mean
809200|NCT01030822|Secondary|Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A|Antibodies assessed for this outcome measure were those against cross-reactive pneumococcal serotypes 6A and 19A (ANTI-6A and -19A). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 µg/mL. Antibody concentrations < 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|Prior to vaccination (PRE), one month post-Dose 2 (Month 3), prior to (Month 6) and one month after the third (booster) vaccine dose (Month 7)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at the requested time points.||microgram/milliliter||95% Confidence Interval|Geometric Mean
809201|NCT01030822|Secondary|Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A|Antibodies assessed for this outcome measure were those against the cross-reactive pneumococcal serotypes 6A and 19A (ANTI-6A and -19A). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 µg/mL. Antibody concentrations < 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|Prior to booster vaccination (PRE), one month after booster vaccination (Month 1) and at approximately 24 months of age: at Month 15 for the Synflorix 1 Group and at Month 9 for the Synflorix 2 Group (24 months of age)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at the requested time points.||microgram/milliliter||95% Confidence Interval|Geometric Mean
809202|NCT01030822|Secondary|Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Persistence)|Antibodies assessed for this outcome measure were those against cross-reactive pneumococcal serotypes 6A and 19A (ANTI-6A and -19A). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 µg/mL. Antibody concentrations < 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|Prior to booster vaccination (PRE) for the Synflorix 1 and Synflorix 2 Groups and prior to catch-up vaccination (PRE) for the Tritanrix-HepB + Hiberix Group|The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom assay results for antibodies against at least one pneumococcal serotype were available before the administration of the booster dose of the Synflorix™ vaccine.||microgram/milliliter||95% Confidence Interval|Geometric Mean
809203|NCT01030822|Secondary|Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F|OPA titers against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Opsono-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seropositivity cut-off for the assay was ≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.|Prior to vaccination (PRE), one month post-Dose 2 (Month 3), prior to (Month 6) and one month after the third (booster) vaccine dose (Month 7)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at the requested time points.||Titer||95% Confidence Interval|Geometric Mean
809204|NCT01030822|Secondary|Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F|OPA titers against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Opsono-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seropositivity cut-off for the assay was ≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.|Prior to booster vaccination (PRE), one month after booster vaccination (Month 1) and at approximately 24 months of age: at Month 15 for the Synflorix 1 Group and at Month 9 for Synflorix 2 Group (24 months of age)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at the requested time points.||Titer||95% Confidence Interval|Geometric Mean
809205|NCT01030822|Secondary|Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Persistence)|OPA titers against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Opsono-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seropositivity cut-off for the assay was ≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.|Prior to booster vaccination (PRE) for the Synflorix 1 and Synflorix 2 Groups and prior to catch-up vaccination (PRE) for the Tritanrix-HepB + Hiberix Group|The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom assay results for antibodies against at least one pneumococcal serotype were available before the administration of the booster dose of the Synflorix™ vaccine.||Titer||95% Confidence Interval|Geometric Mean
809216|NCT01030952|Secondary|Change in Insulin Levels (μU/ml) During Standardized Meal Test at Endpoint From Baseline|This outcome measure calculated the change in insulin levels between groups over time at 0, 30 then 120 minutes|baseline, 3 weeks (end of study)|The Intent to Treat (ITT) population consists of all patients randomized and who have at least one dose of study medication.||(μU/ml)||Standard Deviation|Mean
823268|NCT01170598|Primary|Retention|Percentage of participants who remained in the study (did not withdraw voluntarily).|Baseline, Post-induction (weeks 4-6)|||percentage of participants|||Number
809206|NCT01030822|Secondary|Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Persistence)|Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 µg/mL. Antibody concentrations < 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|Prior to booster vaccination (PRE) for the Synflorix 1 and Synflorix 2 Groups and prior to catch-up vaccination (PRE) for the Tritanrix-HepB+Hiberix Group|The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom assay results for antibodies against at least one pneumococcal serotype were available before the administration of the booster dose of the Synflorix™ vaccine.||microgram/milliliter||95% Confidence Interval|Geometric Mean
809207|NCT01030822|Secondary|Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes|Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 µg/mL. Antibody concentrations < 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|Prior to vaccination (PRE), one month post-Dose 2 (Month 3), prior to (Month 6) and one month after the third (booster) vaccine dose (Month 7)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at the requested time points.||microgram/milliliter||95% Confidence Interval|Geometric Mean
809208|NCT01030822|Primary|Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes|Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 µg/mL. Antibody concentrations < 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|Prior to booster vaccination (PRE), one month after booster vaccination (Month 1) and at approximately 24 months of age: at Month 15 for Synflorix 1 Group and at Month 9 for Synflorix 2 Group (24 months of age)|The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at the requested time points. Primary results are results one month after booster vaccination (Month 1).||microgram/milliliter||95% Confidence Interval|Geometric Mean
809209|NCT01030952|Secondary|Change in Percent of 24 Hour Hyperglycemic Measurements|Measures/compares changes in percentage of hyperglycemia (>7.8mmol/l or 140 mg/dl) in glucose measurements in 24 hours by continuous glucose monitoring system (CGMS) at endpoint from baseline between groups. Reported values are percent change of the base absolute values [100% * ((X-Y)/Y)]|baseline, 3 weeks (end of study)|Intent to Treat population - All patients who received at least one dose of study drug after random allocation and had at least one primary or secondary efficacy evaluation after baseline.||percent of measurements||Standard Deviation|Mean
809210|NCT01030952|Secondary|The Percent of 24 Hour Hypoglycemic Measurements|Measures/compares changes in percentage of hypoglycemia(<3.9mmol/l or <70 mg/dl) in glucose measurements in 24hours by continuous glucose monitoring system (CGMS) at endpoint from baseline between groups. Reported values are percent change of the base absolute values [100% * ((X-Y)/Y)]|baseline, 3 weeks (end of study)|Intent-to-treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable. During different time points, participants with observations at that time point were included in the analysis||percent of measurements||Standard Deviation|Mean
809211|NCT01030952|Secondary|Change in Mean Amplitude of Glycaemic Excursion (MAGE)|mean amplitude of glycaemic excursion (MAGE) is an average of the amplitudes of all glycemic excursions greater than a prespecified threshold size|baseline, 3 weeks (end of study)|Intent to Treat population - All patients who received at least one dose of study drug after random allocation and had at least one primary or secondary efficacy evaluation after baseline. During different time points, participants with observations at that time point were included in the analysis.||mmol/l||Standard Deviation|Mean
809212|NCT01030952|Secondary|Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at the End of the Study|Blood samples were collected for measurement of HDL-C prior to (fasting) and 120 minutes following the start of a standardized meal test at Baseline and Week 3. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM. HDL-C was assessed at each study site using the same method and same reference value.|baseline, 3 weeks (end of study)|Intent to Treat population - All patients who received at least one dose of study drug after random allocation and had at least one primary or secondary efficacy evaluation after baseline. During different time points, participants with observations at that time point were included in the analysis.||millimoles per litre (mmol/l)||Standard Deviation|Mean
809213|NCT01030952|Secondary|Change in Triglyceride (TG)Levels in Blood Lipid Levels During Standardized Meal Test at Endpoint|TG change in blood lipids level from baseline to endpoint|baseline, 3 weeks (end of study)|The Intent to Treat (ITT) population consists of all patients randomized and who have at least one dose of study medication.||millimoles per litre (mmol/l)||Standard Deviation|Mean
809214|NCT01030952|Secondary|Change of Total Cholesterol in Blood Lipids Levels During Standardized Meal Test at Endpoint From Baseline at Each Time Point|time to change in Total Cholesterol blood lipids level at 0, 30, 120 minutes|baseline, 3 weeks (end of study)|The Intent to Treat (ITT) population consists of all patients randomized and who have at least one dose of study medication.||millimoles per litre (mmol/l)||Standard Deviation|Mean
809244|NCT01031004|Primary|Slit Lamp Findings - Corneal Edema|Investigators examined subjects using a slit lamp and the following scale: 0=none, 1=trace, 2=mild, 3=moderate, 4=severe. This outcome measures the number of eyes that had corneal edema graded 2 or higher at the 1-week visit.|after 1 week of lens wear|This analysis includes all participants that completed the study per protocol.||eyes|eyes||Number
809217|NCT01030952|Secondary|Change in Glycated Serum Albumin (GSA) Levels From Baseline After Treatment|GSA levels were to be determined by CGMS at 7:00~10:00 am in the 4-hour standardized meal test before treatment after overnight fasting for efficacy assessments|baseline, 3 weeks (end of study)|Intent to Treat population - All patients who received at least one dose of study drug after random allocation and had at least one primary or secondary efficacy evaluation after baseline. During different time points, participants with observations at that time point were included in the analysis.||percent||Standard Deviation|Mean
809218|NCT01030952|Secondary|Changes in 24 Hour Glucose Area Under Curve (AUCpp)|Blood samples were collected for measurement of plasma glucose at 30, 60, 90, and 120 minutes following the start of a standardized meal test at Baseline and Week 4. The postprandial glucose area under the curve was calculated using values from the 4 time points. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM.|baseline, end of study (3 weeks)|Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable.||mmol*min/L||Standard Deviation|Mean
809219|NCT01030952|Secondary|Change in Mean of Daily Difference of Paired Blood Glucose Value (MODD)|The mean of the daily differences (MODD), calculated as the average absolute difference of paired glucose values during two successive 24 hour periods, was used to assess day-to-day glycaemic variability.|baseline, 3 weeks (end of study)|Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable.||millimoles per litre (mmol/l)||Standard Deviation|Mean
809220|NCT01030952|Secondary|Change in Standard Deviation (SD) From Baseline of Mean Blood Glucose (MBG) Over 24 Hours.|Change in standard deviation (SD) from baseline of mean blood glucose (MBG) describes the range of blood glucose fluctuation over 24 hours.|baseline, 3 weeks (end of study)|Intent to Treat population - All patients who received at least one dose of study drug after random allocation and had at least one primary or secondary efficacy evaluation after baseline||mmol/l||Standard Deviation|Mean
809221|NCT01030952|Secondary|Change in Mean Blood Glucose (MBG)|The 24 hour mean blood glucose (MBG) level was calculated as the mean of all the consecutive readings on baseline and end of study(3 weeks later) separately.|baseline and at 3 weeks (end of study)|Intent to Treat population - All patients who received at least one dose of study drug after random allocation and had at least one primary or secondary efficacy evaluation after baseline||millimoles per litre (mmol/l)||Standard Deviation|Mean
809222|NCT01030952|Secondary|Change in Incremental Glucose Peak (IGP) From Baseline|Incremental glucose peak (IGP) was the maximal incremental increase in blood glucose obtained at any point after meal|baseline, 3 weeks (end of study)|Intent to Treat population - All patients who received at least one dose of study drug after random allocation and had at least one primary or secondary efficacy evaluation after baseline.||millimoles per litre (mmol/L)||Standard Deviation|Mean
809223|NCT01030952|Primary|Change in Area Under Curve of 0-4 Hours Postprandial Glucose (AUCpp0-4hours) in Standardized Meal Test Using Continuous Glucose Monitoring System (CGMS)|"The postprandial glucose area under the curve (AUC)was calculated using values from the 3 time points. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM.
0-4 hours AUC were calculated using trapezoid methods."|3 weeks (end of study) minus baseline|Intent to Treat population - All patients who received at least one dose of study drug after random allocation and had at least one primary or secondary efficacy evaluation after baseline.||millimoles hours per litre (mmol*hr/L)||95% Confidence Interval|Least Squares Mean
809224|NCT01030965|Secondary|Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at Day 1 and Day 28|Serial spirometry assessments were conducted on Day 1 and Day 28 over the course of 24 hours and were obtained 0 (Day 28 only), 1, 3, 6, 23, and 24 hours after dosing. Baseline is defined as the mean of the FEV1 values obtained at 30 minutes and immediately pre-dose on Day 1. Change from Baseline is defined as the difference between FEV1 on Days 1 and 28 and Baseline.|Baseline, Day 1, and Day 28|ITT Population. All participants with >=1 post-BL assessment and non-missing covariate data are included in the analysis. Different participants may have been analyzed at different time points (represented by n=X, X, X, X in the category titles), so the overall number of participants analyzed reflects everyone in the ITT Population.||Liters||Standard Error|Least Squares Mean
809225|NCT01030965|Secondary|Change From Baseline in Weighted Mean 0-6 Hour FEV1 Obtained Post-dose at Day 1 and Day 28|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The weighted mean FEV1 was derived by calculating the area under the FEV1/time curve (AUC), and then dividing the value by the time interval over which the AUC was calculated. The weighted mean was calculated using the 0-6 hour post-dose measurements at Days 1 and 28, which included pre-dose (30 minutes prior to dosing on Day 1, or 24 hours after the previous day's dose on Day 28), and post-dose at 15 minutes, 30 minutes, 1 hour, 3 hours, and 6 hours. Baseline is defined as the mean of the FEV1 values obtained at 30 minutes and immediately pre-dose on Day 1. Change from Baseline is defined as the difference between weighted mean at Days 1 and 28 and Baseline. Analysis was performed using a repeated measures model with covariates of Baseline, country, sex, age, treatment, smoking status, day, day by Baseline interaction, and day by treatment interaction.|Baseline, Day 1, and Day 28|ITT Population. Participants (par.) with >=1 post-BL assessment and non-missing covariate data are included in the analysis. Different par. may have been analyzed at different time points (n=X, X, X, X in the category titles), so the overall number of par. analyzed reflects everyone in the ITT Population with data avaialable at >=1 time point.||Liters||Standard Error|Least Squares Mean
809245|NCT01031043|Primary|Distal Contractile Integral|The index of contractile strength of the esophageal smooth muscle. The range of the index being 0 mmHg *s*cm to >10,000 mmHg *s*cm where 0 represents no contractile strength. The index reflects the magnitude of distal esophageal contraction, taking into consideration the length, strength, and duration of the contraction.|Encounter 1 (day 1) and Encounter 2 (Month 14)|All subjects enrolled in the study||mmHg*s*cm||Standard Deviation|Mean
809246|NCT01031095|Primary|Major Adverse Cardiac Event||30 days|||percentage of event|||Number
809247|NCT01031095|Primary|Major Adverse Cardiac Events||30 days|||percentage of event|||Number
809638|NCT01044264|Primary|Reduction of Inflammatory Lesions|The primary endpoint of the study was the mean percent reduction from baseline to week 11 in inflamed lesion count (papules and pustules).|Baseline and week 11|per-protocol population||percentage reduction of lesions|||Number
809226|NCT01030965|Primary|Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Day 29|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Treatment Day 29 is defined as the mean of the FEV1 values obtained at 23 and 24 hours after dosing on Day 28. Baseline is defined as the mean of the FEV1 values obtained at 30 minutes and immediately pre-dose on Day 1. Change from Baseline is defined as the difference between trough on Day 29 and Baseline. Analysis was performed using a repeated measures model with covariates of Baseline (BL), country, sex, age, treatment, smoking status, day, day by Baseline interaction, and day by treatment interaction.|Baseline and Day 29|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received >=1 dose of randomized study medication in the treatment period. All participants with >=1 post-BL assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 29.||Liters||Standard Error|Least Squares Mean
809227|NCT01031004|Primary|Average Wear Time||after 1 month of lens wear|This analysis includes all participants that completed the study per protocol.||hours per day||Standard Deviation|Mean
809228|NCT01031004|Primary|Average Wear Time||after 1 week of lens wear|This analysis includes all participants that completed the study per protocol.||hours per day||Standard Deviation|Mean
809229|NCT01031004|Primary|Visual Acuity (VA)|Investigators assessed visual acuity per eye using a Snellen visual acuity chart. This outcome measures the number of eyes, wearing vision correction, that measured visual acuity worse than 20/30 at the 1-month visit.|after 1 month|This analysis includes all participants that completed the study per protocol.||eyes|eyes||Number
809230|NCT01031004|Primary|Visual Acuity (VA)|Investigators assessed visual acuity per eye using a Snellen visual acuity chart. This outcome measures the number of eyes, wearing vision correction, that measured visual acuity worse than 20/30 at the 1-week visit.|after 1 week|This analysis includes all participants that completed the study per protocol.||eyes|eyes||Number
809231|NCT01031004|Primary|Subject Reported Symptoms|Number of eyes in which subjects reported lens-related symptoms after 1 month of lens wear.|after 1 month of lens wear|This analysis includes all participants that completed the study per protocol.||eyes|eyes||Number
809232|NCT01031004|Primary|Subject Reported Symptoms|Number of eyes in which subjects reported lens-related symptoms after 1 week of lens wear.|after 1 week of lens wear|This analysis includes all participants that completed the study per protocol.||eyes|eyes||Number
809233|NCT01031004|Primary|Slit Lamp Findings - Infiltrates|Investigators examined subjects using a slit lamp and recorded the presence or absence of infiltrates. This outcome measures the number of eyes that had infiltrates present at the 1-week visit.|after 1 month of lens wear|This analysis includes all participants that completed the study per protocol.||eyes|eyes||Number
809234|NCT01031004|Primary|Slit Lamp Findings - Infiltrates|Investigators examined subjects using a slit lamp and recorded the presence or absence of infiltrates. This outcome measures the number of eyes that had infiltrates present at the 1-week visit.|after 1 week of lens wear|This analysis includes all participants that completed the study per protocol.||eyes|eyes||Number
809235|NCT01031004|Primary|Slit Lamp Findings - Tarsal Abnormalities|Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had tarsal abnormalities graded 2 or higher at the 1-week visit.|after 1 month of lens wear|This analysis includes all participants that completed the study per protocol.||eyes|eyes||Number
809236|NCT01031004|Primary|Slit Lamp Findings - Tarsal Abnormalities|Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had tarsal abnormalities graded 2 or higher at the 1-week visit.|after 1 week of lens wear|This analysis includes all participants that completed the study per protocol.||eyes|eyes||Number
809237|NCT01031004|Primary|Slit Lamp Findings - Injection|Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had injection graded 2 or higher at the 1-week visit.|after 1 month of lens wear|This analysis includes all participants that completed the study per protocol.||eyes|eyes||Number
809238|NCT01031004|Primary|Slit Lamp Findings - Injection|Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had injection graded 2 or higher at the 1-week visit.|after 1 week of lens wear|This analysis includes all participants that completed the study per protocol.||eyes|eyes||Number
809239|NCT01031004|Primary|Slit Lamp Findings - Corneal Staining|Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had corneal staining graded 2 or higher at the 1-week visit.|after 1 month of lens wear|This analysis includes all participants that completed the study per protocol.||eyes|eyes||Number
809240|NCT01031004|Primary|Slit Lamp Findings - Corneal Staining|Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had corneal staining graded 2 or higher at the 1-week visit.|after 1 week of lens wear|This analysis includes all participants that completed the study per protocol.||eyes|eyes||Number
809241|NCT01031004|Primary|Slit Lamp Findings - Corneal Neovascularization|Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had corneal neovascularization graded 2 or higher at the 1-week visit.|after 1 month of lens wear|This analysis includes all participants that completed the study per protocol.||eyes|eyes||Number
809242|NCT01031004|Primary|Slit Lamp Findings - Corneal Neovascularization|Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had corneal neovascularization graded 2 or higher at the 1-week visit.|after 1 week of lens wear|This analysis includes all participants that completed the study per protocol.||eyes|eyes||Number
809243|NCT01031004|Primary|Corneal Edema at Month 1|Number of eyes with corneal edema graded 2 or higher at the 1 month visit. Investigators examined subjects using a slit lamp and the following scale: 0=none, 1=trace, 2=mild, 3=moderate, 4=severe.|after 1 month of lens wear|This analysis includes all participants that completed the study per protocol.||eyes|eyes||Number
809639|NCT01036724|Secondary|Total Procedure Time||Total Duration of the Procedure|||minutes||Full Range|Median
809248|NCT01031134|Secondary|Change in Hamilton Depression Rating Scale Scores|Hamilton Depression Rating Scale change score from baseline to 12 weeks. This scale measures severity of depressive symptoms (range 0-76), with higher scores indicating more severe symptomatology.|Baseline and 12 week|fewer number of participants in comparison to primary outcome measure reflect greater numbers of missing observations for the Hamilton outcome||units on a scale||Standard Deviation|Mean
809249|NCT01031134|Primary|Number of Participants Who Adhered to Physician Recommended Treatment|Any mental health service use over 12 weeks.|12 weeks|||Participants|||Count of Participants
809250|NCT01031381|Secondary|Total Number of Participants Experienced a Response (Complete Response+Partial Response+Stable Disease)|The number participants who experienced Complete Response+Partial Response+Stable Disease per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).|Within 4 weeks (28 days) of study treatment initiation (baseline)|Patients with recurrent ovarian, peritoneal, and fallopian tube cancer who received RAD001 10 mg/day by mouth and bevacizumab 10 mg/kg intravenously every 14 days + imaging every 8-12 weeks||participants|||Number
809251|NCT01031381|Primary|Progression-free Survival (PFS) at 6-months|The percentage of participants who were alive with the disease (cancer) at 6 months after treatment, but whose disease had not worsened/progressed per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).|Up to 36 months (data collection period for the cohort); Up to 6 months for participant|Patients with recurrent ovarian, peritoneal, and fallopian tube cancer who received RAD001 10 mg/day by mouth and bevacizumab 10 mg/kg intravenously every 14 days||percentage of participants||95% Confidence Interval|Number
809252|NCT01031446|Secondary|Time to Progression in Patients With Metastatic Basal-like Breast Cancer.|Median duration in months from on-study to disease progression in patients with metastatic basal-like breast cancer. All patients with basal-like breast cancer are negative for estrogen, progesterone, and human epidermal growth factor (HER2) receptors.|Up to 64 weeks|Patients who are negative for estrogen, progesterone and HER2 receptors. Time to progression was not determined for 5 patients in this group: toxicity (2), withdrew after beginning treatment (1), no progression (1), and on-treatment (1).||months||Full Range|Median
809253|NCT01031446|Primary|Patients With Progression-free Survival|Patients who had not experienced disease progression and who were alive at 6 months after study entry|at 6 months|Patient who received the study drugs. Four patients were not available for measurement of progression at 6 months: toxicity (3), withdrew after beginning treatment (1)||participants|||Number
809254|NCT01031446|Secondary|Time to Progression|Duration in months from date on-study to date patient exhibited progressive disease|Up to 64 weeks|Patients who were available for determination of duration of time to progressive disease. Time to progression is unknown for 8 Phase II patients due to: on-treatment (1), toxicity (3), withdrew after beginning treatment (1), and no progression (3)||months||Full Range|Median
809255|NCT01031446|Secondary|Patients With Overall Response|Per Response Evaluation Criteria in Solid Tumor (RECIST) criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) > 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions|every 12 weeks|Patients for whom an overall response could be measured. Four patients were not evaluable due to: withdrew after beginning treatment (1) and not evaluable due to only 1 cycle of treatment (3).||participants|||Number
809256|NCT01031446|Primary|Maximum Feasible Dose in mg of RAD001 (Everolimus)for Women With Metastatic Breast Cancer|The recommended dose for the Phase II trial will be the most prevalent dose delivered per day in Phase I that allows for safe and feasible administration the medication. The MTD is defined as the dose preceding that at which 2 or more of 3 patients experience dose-limiting toxicity (DLT) during the initial cycle of therapy. DLTs include Common Toxicity Criteria (CTC) Grade 4 neutropenia (absolute neutrophil count [ANC] < 0.5 x 10 9/L for > 5 days), febrile neutropenia (ANC < 1.0 x 10 0/L with fever > 38.5 degrees Centigrade) or documented infection associated with Grade 3-4 neutropenia, CTC Grade 4 thrombocytopenia < 25 x 10 9/L or CTC Grade 3 < 50-25 x 10 9/L thrombocytopenia with bleeding, and Grade 3-4 non-hematologic toxicity despite symptomatic therapy|at 8 weeks|Patients enrolled to determine the safety profile and recommended dose of cisplatin + RAD001 + paclitaxel in women with metastatic breast cancer||mg|||Number
809257|NCT01031446|Primary|Maximum Feasible Dose in Milligrams Per Meter Squared of Body Surface Area (mg/m2) of Cisplatin and Paclitaxel for Women With Metastatic Breast Cancer|The recommended dose for the Phase II trial will be the most prevalent dose delivered per week in Phase I that allows for safe and feasible administration of the medications.The maximum tolerated dose (MTD) is defined as the dose preceding that at which 2 or more of 3 patients experience dose-limiting toxicity (DLT) during the initial cycle of therapy. DLTs include Common Toxicity Criteria (CTC) Grade 4 neutropenia (absolute neutrophil count [ANC] < 0.5 x 10 9/L for > 5 days), febrile neutropenia (ANC < 1.0 x 10 0/L with fever > 38.5 degrees Centigrade) or documented infection associated with Grade 3-4 neutropenia, CTC Grade 4 thrombocytopenia < 25 x 10 9/L or CTC Grade 3 < 50-25 x 10 9/L thrombocytopenia with bleeding, and Grade 3-4 non-hematologic toxicity despite symptomatic therapy.|at 8 weeks|Patients enrolled to determine the safety profile and recommended doses of cisplatin + paclitaxel + everolimus (RAD001) in women with metastatic breast cancer||mg/m2|||Number
809258|NCT01031498|Primary|Number of Patients With Complete Response|Number of emesis (vomiting) episodes and no use of rescue medication during the administration of chemotherapy assessed as complete response. Complete response is defined as < or equal to 1 episode of emesis during entire 7-day study period, no use of of rescue medication during the study period, and no more than moderate nausea (Grade 2, National Cancer Institutes (NCI) Common Terminology Criteria (CTC)) during chemotherapy.|7 days, starting first day of chemotherapy|Analysis was per protocol. Seven patients were excluded from the efficacy analysis.||participants|||Number
809259|NCT01031550|Secondary|Decrease in Liver Lipid Peroxidation and Apoptosis||first 7 post operative days|Due to termination of the study no data analysis was performed.|||||
809260|NCT01031550|Secondary|Length of ICU and Hospital Stay||first 7 post operative days|Due to termination of the study no data analysis was performed.|||||
809261|NCT01031550|Secondary|Peak Postoperative AST, ALT and T Bili||first 7 post operative days|Due to termination of the study no data analysis was performed.|||||
824373|NCT01173471|Primary|Percentage Change in Mean Intra-ocular Pressure Compared With Baseline After 4 Weeks Treatment||Baseline to 4 weeks|Efficacy analysis set||Percentage change||95% Confidence Interval|Least Squares Mean
809262|NCT01031550|Primary|Post Operative Complications Grade IIIb or Greater According to Clavien's Classification Which is a Classification System Used to Grade Surgical Complications|Post operative complications grade IIIB or greater according to Clavien's classification: IIIb=complication necessitating an intervention under general anesthesia; Grade IV=Life threatening complications requiring ICU management, IV a =single organ dysfunction, IVb=multi-organ dysfunction; V=death Suffix d(disability)=subject suffers from complication at time of discharge. This label indicates the need for a follow up to fully evaluate the complication.|first 7 post operative days|Due to termination of the study no data analysis was performed.|||||
809263|NCT01031628|Primary|Evaluation of Lesions for Progression or Response Via RECIST Criteria||Every 3 months|Data were not collected or analyzed due to early termination.|||||
809264|NCT01031680|Secondary|Proportion of Participants With a Reduction From Baseline of 5% or More in Body Weight in Participants With Baseline BMI ≥27 kg/m²|To compare the proportion of participants with BMI baseline ≥27 kg/m2 with a reduction from baseline of 5% or more in body weight with dapagliflozin 10 mg versus placebo from baseline to week 24. Least Squares Mean represents the percent of participants adjusted for baseline body weight and age stratum.|Baseline to Week 24|Full analysis set; participants with baseline BMI ≥27 kg/m² and Week 24 (LOCF) body weight value||Percentage of participants||95% Confidence Interval|Least Squares Mean
809265|NCT01031680|Secondary|Adjusted Mean Change in Seated Systolic Blood Pressure (SBP) at Week 24 (LOCF)|To compare the mean change in seated systolic blood pressure from baseline to week 24 between dapagliflozin 10 mg versus placebo.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values||mmHg||95% Confidence Interval|Least Squares Mean
809266|NCT01031680|Secondary|Adjusted Mean Percent Change in Body Weight|To compare the mean percent change in body weight from baseline to week 24 between dapagliflozin 10 mg versus placebo.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values||Percentage of Body Weight||95% Confidence Interval|Least Squares Mean
809267|NCT01031680|Secondary|Adjusted Mean Change in Seated Systolic Blood Pressure (SBP)|To compare the mean change in seated systolic blood pressure from baseline to week 8 between dapagliflozin 10 mg versus placebo.|Baseline to Week 8|Full Analysis Set, participants with non-missing baseline and Week 8 (LOCF) values||mmHg||95% Confidence Interval|Least Squares Mean
809268|NCT01031680|Primary|Proportion of Responders Meeting All Criteria of a 3-item Endpoint of Clinical Benefit|To compare the clinical benefit of dapagliflozin 10 mg versus placebo when added to usual care in type 2 diabetes patients with cardiovascular disease and hypertension at week 24, measured as the proportion of responders for a 3-item endpoint of clinical benefit, defined as an absolute drop of 0.5% or more from baseline HbA1c, and a relative drop of 3% or more from baseline for total body weight, and an absolute drop of 3 mmHg or more from baseline in seated systolic blood pressure.|Baseline to week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values||Percentage of participants||95% Confidence Interval|Number
809269|NCT01031680|Primary|Adjusted Mean Change in HbA1c Levels|To compare the glycemic efficacy of dapagliflozin 10 mg versus placebo when added to usual care in type 2 diabetes patients with cardiovascular disease and hypertension, measured as the mean change in HbA1c from baseline to week 24.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values||Percent||95% Confidence Interval|Least Squares Mean
809270|NCT01031706|Secondary|FEV1 (Spirometry) Change|Absolute change in % predicted FEV1 between baseline and after 4 weeks of treatment calculated|Baseline and after 4 weeks of treatment|All available data included. Carry-forward of last FEV1 value (after 2 weeks of treatment) performed when data at 4 week time point not available||Percentage of predicted FEV1||Standard Error|Mean
809271|NCT01031706|Primary|Change in Mucociliary Clearance Rate|"Average radio tracer clearance through 90 minutes (MCC90) is primary index of mucociliary clearance at each study.
Primary study outcome: is absolute change in MCC90 between baseline and at end of treatment (where MCC measured 8-12 hours after final dose of study drug) - reflects sustained impact on MCC"|Baseline versus after completion of 4 week treatment period|All subjects with available data analyzed||percent clearance||Standard Error|Mean
809272|NCT01031810|Primary|Hamilton Depression Rating Scale Scores 17 at week12|"HAM-D is a multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery. Each item on the questionnaire is scored on a 3 or 5 point scale, depending on the item, and the total score is compared to the corresponding descriptor.
Scale range (0-52):
A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression, and are usually required for entry into a clinical trial."|Week 12|||Score on a scale||Standard Deviation|Mean
809273|NCT01031810|Secondary|Quick Inventory of Depression- Self Report 16|"Quick Inventory of Depression- Self Report assesses 16 depressive symptoms experienced in the past week, based on self-rating, measured at study exit visit
Scale range (0-27):
Each of the four possible answers to each quiz is given an ascending numerical value from 0 to 3, and the total test score is the sum of the following: The highest number from questions 1-4 The number from question 5 The highest number from questions 6-9 The total of each question from 10-14 The highest number from questions 15-16
Total score interpretation: 0-5 no depression, 6-10 mild depression, 11-15 moderate depression, 16-20 severe depression, 20 and above very severe depression"|Week 16|||units on a scale||Standard Deviation|Mean
809274|NCT01031810|Secondary|Quick Inventory of Depression- Self Report 16|"Quick Inventory of Depression- Self Report assesses 16 depressive symptoms experienced in the past week, based on self-rating, measured at study exit visit
Scale range (0-27):
Each of the four possible answers to each quiz is given an ascending numerical value from 0 to 3, and the total test score is the sum of the following: The highest number from questions 1-4 The number from question 5 The highest number from questions 6-9 The total of each question from 10-14 The highest number from questions 15-16
Total score interpretation: 0-5 no depression, 6-10 mild depression, 11-15 moderate depression, 16-20 severe depression, 20 and above very severe depression"|Week 12|||units on a scale||Standard Deviation|Mean
809365|NCT01032382|Secondary|Pharmacokinetic Parameter: t(1/2)|t(1/2) of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama|0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20|Adults (18+ years). WR 279,396 group measurements Day 1 N = 2 and Day 20 N = 4. One study participant in the Paromomycin Alone Treatment was withdrawn at Day 100.||hr||Standard Deviation|Mean
829554|NCT01220557|Secondary|Diabetes Self-Efficacy Scale|A German version of the Diabetes Self-efficacy Scale was used to assess diabetes specific self-efficacy.|6 Month Follow up||||||
809275|NCT01031810|Secondary|Quick Inventory of Depression- Self Report 16|"Quick Inventory of Depression- Self Report assesses 16 depressive symptoms experienced in the past week, based on self-rating, measured at study exit visit
Scale range (0-27):
Each of the four possible answers to each quiz is given an ascending numerical value from 0 to 3, and the total test score is the sum of the following: The highest number from questions 1-4 The number from question 5 The highest number from questions 6-9 The total of each question from 10-14 The highest number from questions 15-16
Total score interpretation: 0-5 no depression, 6-10 mild depression, 11-15 moderate depression, 16-20 severe depression, 20 and above very severe depression"|Week 04|||units on a scale||Standard Deviation|Mean
809276|NCT01031810|Secondary|Quick Inventory of Depression- Self Report 16|"Quick Inventory of Depression- Self Report assesses 16 depressive symptoms experienced in the past week, based on self-rating, measured at study exit visit
Scale range (0-27):
Each of the four possible answers to each quiz is given an ascending numerical value from 0 to 3, and the total test score is the sum of the following: The highest number from questions 1-4 The number from question 5 The highest number from questions 6-9 The total of each question from 10-14 The highest number from questions 15-16
Total score interpretation: 0-5 no depression, 6-10 mild depression, 11-15 moderate depression, 16-20 severe depression, 20 and above very severe depression"|Weeks 00|||units on a scale||Standard Deviation|Mean
809277|NCT01031810|Primary|Hamilton Depression Rating Scale Scores 17 at Baseline|"HAM-D is a multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery. Each item on the questionnaire is scored on a 3 or 5 point scale, depending on the item, and the total score is compared to the corresponding descriptor.
Scale range (0-52):
A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression, and are usually required for entry into a clinical trial."|Week 00 (baseline)|||units on a scale||Standard Deviation|Mean
809278|NCT01031914|Primary|Sleep/Wake Algorithm|We tested the ability of the Sleep/Wake algorithm to identify sleep an wake periods with precision, as compared to standard polysonography (PSG) measures, which was used as the gold standard, i.e. we tested the accuracy of the algorithm. Accuracy was defined as the proportion of true results (both true positives and true negatives)in the population and it was assesed using as 2 X 2 table, i.e. accuracy = number of true positives + number of true negatives/ number of true positives + false positives + false negatives +true negatives. where True positive = the algorithm tested correctly identified sleep, False positive = the algorithm tested incorrectly identified sleep, True negative = the algorithm tested correctly rejected awake periods, and False negative = the algorithm tested incorrectly rejected awake periods.|The performance of the algorithm will be evaluated in real time while the subject is wearing the device during the sleep study, an average of 08 hours.|All the participants completing the sleep study were included in the analysis||accuracy (%)|||Number
809279|NCT01031953|Secondary|Participants With Specific Side Effects, Including Pain Sensation/Soreness at the Infusion Site, Headache, and Dizziness|Participants who self report pain/soreness at drug infusion site, headache, or dizziness at any of the study time points (2, 12, or 24 hours after receiving fosaprepitant) are measured in this outcome.|up to 24 hours after study drug administered.|||participants|||Number
809280|NCT01031953|Secondary|Participants With Increased Fatigue or Sedation Within 24 Hours After Receiving Fosaprepitant|Participants meeting this outcome self report experiencing drowsiness at any of the study time points (2, 12 or 24 hours after receiving fosaprepitant).|up to 24 hours after study drug administered.|||participants|||Number
809281|NCT01031953|Secondary|Participants Achieving a Complete Response (no Emesis, no Additional Rescue Medication Required)|The recommended dose Fosaprepitant (MK-0517) is 115 mg administered intravenously 30 minutes before chemotherapy treatment. In this study, a 150 mg dose will be given to study patients as rescue therapy after chemotherapy only in the event of breakthrough nausea or vomiting. Those participants who did not report episodes of emesis or did not require additional rescue medications are measured in this outcome|up to 24 hours after receiving fosaprepitant|||participants|||Number
809282|NCT01031953|Secondary|Participants Who Required the Use of Second Rescue Drug (Time to Treatment Failure)|Participants with persistent nausea/vomiting after 2 hours and who desired further treatment, received standard rescue therapy at the discretion of provider with prochlorperazine, metoclopramide or haloperidol with or without additional lorazepam until relief|2 hours after administration of Fosaprepitant 150 mg IV|||participants|||Number
809283|NCT01031953|Secondary|Number of Participants Who Experienced Vomiting Episodes From Baseline to 24 Hours|Participants were asked to report any episodes of vomiting before (baseline) and up to 24 hours after receiving Fosaprepitant. The outcome considers the number of participants reporting any episodes of emesis after receiving Fosaprepitant.|Baseline to 24 hours after study drug administered.|||participants|||Number
809284|NCT01031953|Secondary|Improvement in Nausea Score From 2 Hours to 24 Hours|"The outcome measure is the number of participants that self report improvement in a nausea score from 2 hours after receiving fosaprepitant to 24 hours post dose. This includes only participants who report breakthrough nausea or vomiting after chemotherapy and after receiving prophylactic anti-emetics. The outcome is measured using the visual analogue scale, a self report scale from No Nausea to Nausea as bad as it can be; a value can be indicated anywhere on this scale using a free hand mark by the participant and gauged with ruler by study staff. Any participant reporting a lower value on the scale at the 12 or 24 hour time point would be considered in this outcome measure."|2 hours to 24 hours after study drug administered.|||participants|||Number
809285|NCT01031953|Secondary|Improvement in Nausea Score From Baseline to 12 Hours|"The outcome measure is the number of participants that self report improvement in a nausea score from baseline, prior to fosaprepitant, to 12 hours post dose. This includes only participants who report breakthrough nausea or vomiting after chemotherapy and after receiving prophylactic anti-emetics. The primary outcome is measured using the visual analogue scale, a self report scale from No Nausea to Nausea as bad as it can be; a value can be indicated anywhere on this scale using a free hand mark by the participant and gauged with ruler by study staff. Any participant that reported a lower value on the scale 12 hours from baseline would be considered in this outcome measure."|Baseline to 12 hours after study drug administered.|||participants|||Number
809366|NCT01032382|Secondary|Pharmacokinetic Parameter: Area Under the Curve (AUC)|Area under the curve (AUC) of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama|0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20|Adults (18+ years)||ng*hr/mL||Standard Deviation|Mean
809286|NCT01031953|Primary|Improvement in Nausea Score From Baseline to 2 Hours as Assessed by the Numerical Visual Analogue Scale|"The outcome measure is the number of participants that self report improvement in a nausea score from baseline, prior to fosaprepitant, to 2 hours post dose. This includes only participants who report breakthrough nausea or vomiting after chemotherapy and after receiving prophylactic anti-emetics. The primary outcome is measured using the visual analogue scale, a self report scale from No Nausea to Nausea as bad as it can be; a value can be indicated anywhere on this scale using a free hand mark by the participant and gauged with ruler by study staff. Any participant that reported a lower value on the scale 2 hours from baseline would be considered in this outcome measure."|Baseline to 2 hours after study drug administered.|||participants|||Number
809287|NCT01031979|Secondary|Change in Becks Depression Inventory (BDI-II) Score|The BDI-II is a 21-item self-report measure that assesses depressive behavioral symptoms. It has demonstrated adequate psychometric validity, and external validity and is used widely as the dependent variable in treatment outcomes research. The BDI-II produces score ranges from 0-63, with higher scores indicating more severe depression symptom severity. A 5-point decrease on the BDI-II is considered clinically significant.|0 weeks, 15 weeks|||units on a scale||Standard Deviation|Mean
809288|NCT01031979|Secondary|Change in Post Traumatic Stress Disorder Checklist (PCL) Score|The PCL is a 17-item self-report measure of PTSD symptom severity based on the DSM-IV and has adequate psychometric properties. The PCL produces a score range between 17-85, with higher scores indicating more distress related to PTSD symptoms. A 10-point decrease on the PCL is considered clinically significant.|0 weeks, 15 weeks|||units on a scale||Standard Deviation|Mean
809289|NCT01031979|Secondary|Change in Clinician Administered PTSD Scale (CAPS) Score|The CAPS is a structured interview for diagnosis of PTSD and is widely considered the gold-standard assessment. The CAPS produces a total score ranging from 0-136, with higher scores indicating more severe PTSD symptom severity. A 15-point decrease is considered clinically significant.|0 Weeks, 15 weeks|||units on a scale||Standard Deviation|Mean
809290|NCT01031979|Primary|Trauma-Cued Heart Rate Reactivity|The primary outcome was trauma-cued heart rate reactivity a week after the drug visit as measured by the PTSD Brief Reactivity (PBR) task. For each patient, a 3-minute trauma script was constructed containing vivid details of the target trauma and used in tandem with a standard neutral script for baseline measurement. Heart rate reactivity for each time point was the beats per minute (BPM) difference between the neutral and trauma scripts represented as a slope.|One week after drug visit|||beats per minute||Standard Error|Mean
809291|NCT01032018|Primary|Cost for Healthcare Utilization (Psychiatric Medications, Hospitalizations, Cardiac Procedures, Outpatient Services)||6 months after randomization|||dollars||Standard Error|Mean
809292|NCT01032018|Primary|Depressive Symptom Reduction|Symptoms of depression were assessed using the Beck Depression Inventory (BDI). This 21-question, multiple choice self-report instrument includes items pertaining to symptoms of depression, including hopelessness and irritability, physical symptoms such as fatigue, and thoughts such as guilt. Each item has at a set of four possible responses, ranging in intensity for least intense to most intense. The total score is calculated by adding the responses to each item. Higher scores indicate more severe depressive symptoms. The total score on the scale ranges from 0 to 63. Total scores on the scale of less 10 indicate minimal depression; total scores between 10 and 15 indicate mild depression; and total scores greater than 16 indicate a probable clinical diagnosis of depression.|Change from depression at baseline to depression at 6-months|||Scores on a scale||Standard Deviation|Mean
809293|NCT01032044|Primary|"Number of Barrett's Esophagus (BE) Participants With a Composite Outcome of Optimally Treated"|"Number of Barrett's Esophagus (BE) Participants with a Composite Outcome of Optimally Treated, in each group defined as patients for whom all lesions are ablated when disease is present, or not ablated when disease is absent, or have complete ablation of all disease at the 3 month follow-up."|3 month follow-up endoscopic procedure|Among the 141 patients who completed the initial procedure, 119 had follow-up visits.||participants|||Number
809294|NCT01032070|Secondary|Apparent Volume of Distribution (Vz/F) of Erlotinib|Pharmacokinetic parameters were determined from the serial plasma concentration data obtained for erlotinib. The apparent volume of distribution (Vz/F) of erlotinib was measured at steady state on Day 14 using sparse sampling.|Day 14 predose and 0.5 to 1.5 hours, 2 to 3 hours and 4 to 8 hours post-dose.|The Pharmacokinetics Analysis Set||mL/m^2||95% Confidence Interval|Geometric Mean
809295|NCT01032070|Secondary|Apparent Body Clearance (CL/F) of Erlotinib|Pharmacokinetic parameters were determined from the serial plasma concentration data obtained for erlotinib. Apparent body clearance (CL/F) of erlotinib was measured at steady state on Day 14 using sparse sampling.|Day 14 predose and 0.5 to 1.5 hours, 2 to 3 hours and 4 to 8 hours post-dose.|The Pharmacokinetics Analysis Set||mL/h/m^2||95% Confidence Interval|Geometric Mean
809296|NCT01032070|Secondary|Time to Maximum Observed Plasma Concentration of Erlotinib (Tmax)|Pharmacokinetic parameters were determined from the serial plasma concentration data obtained for erlotinib. Time to the maximum observed plasma concentration of erlotinib (Tmax) was measured at steady state on Day 14 using sparse sampling.|Day 14 predose and 0.5 to 1.5 hours, 2 to 3 hours and 4 to 8 hours post-dose.|The Pharmacokinetics Analysis Set||hours||95% Confidence Interval|Geometric Mean
809297|NCT01032070|Secondary|Maximum Observed Plasma Concentration of Erlotinib (Cmax)|Pharmacokinetic parameters were determined from the serial plasma concentration data obtained for erlotinib. Maximum observed plasma concentration of erlotinib (Cmax) was measured at steady state on Day 14 using sparse sampling.|Day 14 predose and 0.5 to 1.5 hours, 2 to 3 hours and 4 to 8 hours post-dose.|The Pharmacokinetics Analysis Set||ng/mL||95% Confidence Interval|Geometric Mean
809298|NCT01032070|Secondary|Area Under the Curve From Time 0 to 24 Hours Post-dose for Erlotinib|Pharmacokinetic parameters were determined from the serial plasma concentration data obtained for erlotinib. Area under the plasma concentration-time curve from time zero to 24 hours (the dosing interval) measured at steady state using sparse sampling.|Day 14 predose and 0.5 to 1.5 hours, 2 to 3 hours and 4 to 8 hours post-dose.|The Pharmacokinetics Analysis Set (PKAS) consisted of the participants treated with erlotinib for whom sufficient analyte concentration data were available to facilitate derivation of at least 1 primary pharmacokinetic parameter. Participants may have been excluded from the PKAS for reasons such as missing data or protocol deviation.||h*ng/mL||95% Confidence Interval|Geometric Mean
809367|NCT01032382|Secondary|Pharmacokinetic Parameter: Tmax|Pharmacokinetic Parameter: Tmax|0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20|Adults (18+ years). On day 1, Paromomycin Alone Treatment group N = 4; WR 279,396 group N = 3.||hr||Standard Deviation|Mean
809299|NCT01032070|Secondary|Safety Assessed Through Evaluation of Physical Exams, Vital Signs, Clinical Laboratory Tests and Adverse Events (AEs)|"An AE was defined as any untoward medical occurrence in a study participant and did not necessarily have a causal relationship with study treatment. Clinically significant vital sign assessments, findings on physical or neurological examination, and laboratory findings associated with signs and/or symptoms requiring withdrawal, dose modification or medical intervention were recorded as AEs.
An AE was considered serious if it resulted in death, a life-threatening situation, inpatient hospitalization or prolongation of an existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of a patient who received study drug or other important medical events. The relationship of each AE to study drug was assessed as either related or not related."|From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.|All enrolled participants who received at least 1 dose of study drug (Safety Analysis Set).||participants|||Number
809300|NCT01032070|Secondary|Overall Survival (OS)|Overall survival was defined as the time from the date of randomization until the documented date of death. Participants who were still alive by the data cutoff date for analysis were censored on the last day the participant was known to be alive.|From randomization up to 12 months after the last dose. Median duration of follow-up was 12.9 months for erlotinib and 14.4 months for etoposide.|The Full Analysis Set||days||95% Confidence Interval|Median
809301|NCT01032070|Secondary|Duration of Stable Disease|"Duration of stable disease (SD; defined as participants with an overall best response of complete, partial or minor response or stable disease) was defined as the time from the date of randomization to the first documented progression or death due to underlying cancer. If a participant had not progressed or died, the duration of SD was censored at the date of last adequate disease assessment. Duration of SD was only defined for participants whose best overall response was CR or PR or MR or SD.
Progression was defined as a worsening of neurologic status that could not be explained by other causes, a > 25% increase in tumor size, the appearance of new lesions or CSF positivity, or increasing doses of corticosteroids required to maintain stable status."|From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.|Full Analysis Set participants whose best overall response was CR, PR, MR or SD.||days||95% Confidence Interval|Median
809302|NCT01032070|Secondary|Percentage of Participants With Prolonged Stable Disease|Prolonged stable disease (SD) was defined as SD with a duration of at least 16 weeks. The percentage of participants with prolonged SD was defined as participants who achieved a best overall response of CR or PR or MR or SD, and did not progress within 16 weeks from randomization. Progression was defined as a worsening of neurologic status that could not be explained by other causes, a > 25% increase in tumor size, the appearance of new lesions or CSF positivity, or increasing doses of corticosteroids required to maintain stable status.|From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.|The Full Analysis Set||percentage of participants||95% Confidence Interval|Number
809303|NCT01032070|Secondary|Progression Free Survival (PFS)|"Progression-free survival was defined as the time from randomization to disease progression based on central nervous system (CNS)-specific evaluation criteria as assessed by the investigator or death due to any cause, whichever occurs first.
Participants did not progress or die before the data cutoff date for analysis were censored at the date of last disease assessment (including both radiologic assessment and neurologic assessment) where non-progression was documented. If a participant received any further anticancer therapy without prior documentation of disease progression, the participant was censored at the date of last disease assessment before starting new anti-cancer treatment. Participants were also censored at the date of last disease assessment with no documented progression if patients discontinued treatment for undocumented progression, toxicity or other reason before the data cutoff date for analysis."|From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.|The Full Analysis Set||days||95% Confidence Interval|Median
809304|NCT01032070|Secondary|Percentage of Participants With Disease Control|"Disease control is a best overall response of CR or PR or MR or Stable disease (SD).
CR:
Complete disappearance of all enhancing tumor and mass effect
On a stable or decreasing dose of corticosteroids
Stable or improving neurologic examination sustained for ≥ 4 weeks
If CSF evaluation was positive, it must become negative (confirmed at least 2 times consecutively).
PR:
≥ 50% reduction in tumor size by bi-dimensional measurement
On a stable or decreasing dose of corticosteroids
Stable or improving neurologic examination sustained for ≥ 4 weeks.
MR:
≥ 25% to < 50% reduction in tumor size by bi-dimensional measurement
On a stable or decreasing dose of corticosteroids
Stable or improving neurologic examination sustained for ≥ 4 weeks.
SD:
Neurologic examination is at least stable
Maintenance corticosteroid dose is not increased
MRI meets neither the criteria for minor response nor for progressive disease
Sustained for ≥ 8 weeks."|From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.|The Full Analysis Set||percentage of participants||95% Confidence Interval|Number
809305|NCT01032070|Secondary|Percentage of Participants With a Minor Response|"Participants with a best overall response of minor response (MR), defined as:
≥ 25% to < 50% reduction in tumor size by bi-dimensional measurement
On a stable or decreasing dose of corticosteroids
Stable or improving neurologic examination sustained for ≥ 4 weeks."|From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.|The Full Analysis Set||percentage of participants||95% Confidence Interval|Number
809306|NCT01032070|Secondary|Duration of Response|"Duration of response (complete or partial response [CR/PR]) was defined as the time from the date of the first documented response (CR/PR) to the first documented progression or death due to underlying cancer. If a participant had not progressed or died, the duration of overall response was censored at the date of last adequate disease assessment. Duration of response was only defined for participants whose best overall response was CR or PR.
Progression was defined as a worsening of neurologic status that could not be explained by other causes, a > 25% increase in tumor size, the appearance of new lesions or CSF positivity, or increasing doses of corticosteroids required to maintain stable status."|From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.|Full Analysis Set participants whose best overall response was CR or PR.||days||95% Confidence Interval|Median
831847|NCT01243320|Primary|Change In Calcium Blood Level|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days|||mg/dL||95% Confidence Interval|Mean
809307|NCT01032070|Primary|Percentage of Participants With an Objective Response|"Objective response is defined as a best overall response of complete response (CR) or partial response (PR), evaluated using modified International Society of Pediatric Oncology Brain, Tumor Subcommittee for the Reporting of Trials criteria. Response was confirmed at least 28 days after the first assessment where the response criteria were met. Response was assessed by magnetic resonance imaging (MRI) every 8 weeks.
CR:
Complete disappearance of all enhancing tumor and mass effect
On a stable or decreasing dose of corticosteroids (or receiving only adrenal replacement doses)
Stable or improving neurologic examination sustained for ≥ 4 weeks
If cerebral spinal fluid (CSF) evaluation was positive, it must become negative (confirmed at least 2 times at consecutive samplings).
PR:
≥ 50% reduction in tumor size by bi-dimensional measurement
On a stable or decreasing dose of corticosteroids
Stable or improving neurologic examination sustained for ≥ 4 weeks."|From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.|The Full Analysis Set (FAS) consisted of all randomized participants. Following the intent-to-treat (ITT) principle, participants were analyzed according to the treatment arm they were assigned to at randomization.||percentage of participants||95% Confidence Interval|Number
809308|NCT01032135|Primary|Percent Days Cocaine Use|Percent days of any cocaine use, self reported|Month 6 (weeks 21 - 24 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.||percentage of days||Standard Deviation|Mean
809309|NCT01032135|Primary|Percent Days Cocaine Use|Percent days of any cocaine use, self reported|Month 5 (weeks 17 - 20 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.||percentage of days||Standard Deviation|Mean
809310|NCT01032135|Primary|Percent Days Cocaine Use|Percent days of any cocaine use, self reported|Month 3 (weeks 9 - 12 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.||percentage of days||Standard Deviation|Mean
809311|NCT01032135|Primary|Any Cocaine Use|Any cocaine using self report, binary measure of percent days cocaine use|Month 6 (weeks 21 - 24 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.||proportion of participants||Standard Deviation|Mean
809312|NCT01032135|Primary|Any Cocaine Use|Any cocaine using self report, binary measure of percent days cocaine use|Month 5 (weeks 17 - 20 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.||proportion of participants||Standard Deviation|Mean
809313|NCT01032135|Primary|Any Cocaine Use|Any cocaine using self report, binary measure of percent days cocaine use|Month 4 (weeks 13 - 16 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.||proportion of participants||Standard Deviation|Mean
809314|NCT01032135|Primary|Any Cocaine Use|Any cocaine using self report, binary measure of percent days cocaine use.|Month 3 (weeks 9 - 12 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.||proportion of participants||Standard Deviation|Mean
809315|NCT01032135|Primary|Percent Days Heavy Drinking|"Percent days heavy drinking at follow up, from Time Line Follow Back
*heavy drinking is defined as five or more drinks per drinking day for men, four or more for women"|Month 6 (weeks 21 - 24 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.||percentage of days||Standard Deviation|Mean
809316|NCT01032135|Primary|Percent Days Heavy Drinking|"Percent days heavy drinking at follow up, from Time Line Follow Back
* heavy drinking is defined as five or more drinks per drinking day for men, four or more for women"|Month 5 ( weeks 17 - 20 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.||percentage of days||Standard Deviation|Mean
809317|NCT01032135|Primary|Percent Days Heavy Drinking|"Percent days heavy drinking at follow up, from Time Line Follow Back
*heavy drinking is defined as five or more drinks per drinking day for men, four or more for women"|Month 4 (weeks 13 - 16 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.||percentage of days||Standard Deviation|Mean
809318|NCT01032135|Primary|Percent Days Heavy Drinking|"Percent days heavy drinking at follow up, from Time Line Follow Back
* heavy drinking is defined as five or more drinks per day for men, four or more for women."|Month 3 (weeks 9 - 12 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.||percentage of days||Standard Deviation|Mean
809319|NCT01032135|Primary|Percent Days Heavy Drinking|"Percent days heavy drinking at follow up, from Time Line Follow Back
*heavy drinking is defined as five or more drinks per day for men, four or more for women"|Month 2 (weeks 5 - 8 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.||percentage of days||Standard Deviation|Mean
809320|NCT01032135|Primary|Any Heavy Drinking Days|five or more drinks per day for men, four or more drinks per day for women, from Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of heavy drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample engaged in heavy drinking in the follow up period.|Month 6 (weeks 21 - 24 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.||proportion of participants||Standard Deviation|Mean
809321|NCT01032135|Primary|Any Heavy Drinking Days|five or more drinks per day for men, four or more drinks per day for women, from Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of heavy drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample engaged in heavy drinking in the follow up period.|Month 5 (weeks 17 to 20 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.||proportion of participants||Standard Deviation|Mean
809322|NCT01032135|Primary|Any Heavy Drinking Days|five or more drinks per drinking day for men, four or more drinks per drinking day for women at follow up, from Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of heavy drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample engaged in heavy drinking in the follow up period.|Month 4 (weeks 13 - 16 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.||proportion of participants||Standard Deviation|Mean
809323|NCT01032135|Primary|Any Heavy Drinking Days|five or more drinks per drinking day for men, four or more drinks per drinking day for women, at follow up, from Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of heavy drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample engaged in heavy drinking in the follow up period.|Month 3 (weeks 9 - 12 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.||proportion of participants||Standard Deviation|Mean
809324|NCT01032135|Primary|Any Heavy Drinking Days|days of five or more drinks per drinking day for men, four or more drinks per drinking day for women, at follow up, from Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of heavy drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample engaged in heavy drinking in the follow up period.|Month 2 (weeks 5 - 8 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.||proportion of participants||Standard Deviation|Mean
809325|NCT01032135|Primary|Percent Days Drinking|Percent days of any drinking at follow up, from Time Line Follow Back|Month 6 (weeks 21 - 24)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.||percentage of days||Standard Deviation|Mean
809326|NCT01032135|Primary|Percent Days Drinking|Percent days of any drinking at follow up, fromTime Line Follow Back|Month 5 (weeks 17 - 20 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.||percentage of days||Standard Deviation|Mean
809327|NCT01032135|Primary|Percent Days Drinking|Percent days of any drinking at follow up, from Time Line Follow Back|Month 4 (weeks 13 - 16 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.||percentage of days||Standard Deviation|Mean
809328|NCT01032135|Primary|Percent Days Drinking|Percent days of any drinking at follow up, from Time Line Follow Back|Month 3 (weeks 9 - 12 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.||percentage of days||Standard Deviation|Mean
809329|NCT01032135|Primary|Percent Days Drinking|Percent days of any drinking at follow up, from Time Line Follow Back|Month 2 (weeks 5 - 8 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.||percentage of days||Standard Deviation|Mean
809330|NCT01032135|Primary|Any Drinking|Any drinking at follow up, as reported on Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample drank in the follow up period.|Month 6 (weeks 21 - 24 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.||proportion of participants||Standard Deviation|Mean
809331|NCT01032135|Primary|Any Drinking|Any drinking at follow up, as reported on Time Line Follow Back, This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample drank in the follow up period.|Month 5 (weeks 16 - 20 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.||proportion of participants||Standard Deviation|Mean
809332|NCT01032135|Primary|Any Drinking|Any drinking at follow up, as reported on Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample drank in the follow up period.|Month 4 (weeks 13 - 15 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.||proportion of participants||Standard Deviation|Mean
809368|NCT01032382|Secondary|Pharmacokinetic Parameter: Cmax|Cmax of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama|0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20|Adults (18+ years)||ng/mL||Standard Deviation|Mean
809369|NCT01032382|Secondary|Paromomycin Plasma Concentrations in Children|Paromomycin plasma concentrations 4 hours following administration of paromomycin alone or WR 279,396 in children|0 and 4 hours on days 1 and 20|Children ages 5 to 17 (inclusive)||ng/mL||Standard Deviation|Mean
809333|NCT01032135|Primary|Any Drinking Days in Previous Month|Any drinking days during previous month, as reported on Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample drank in the follow up period.|Month 3 (weeks 9 - 12 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.||proportion of participants||Standard Deviation|Mean
809334|NCT01032135|Primary|Any Drinking Days in Previous Month|Days of any drinking in previous month, as reported on Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample drank in the follow up period.|Month 2 (weeks 5 - 8 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.||proportion of participants||Standard Deviation|Mean
809335|NCT01032135|Primary|Treatment Engagement of Those Non-engaged at 2 Weeks and at 8 Weeks|Number of treatment sessions attended|weeks 9 - 12|||treatment days||Standard Deviation|Mean
809336|NCT01032135|Primary|Treatment Engagement for Participants Engaged at 2 Weeks, But Disengage Before 8 Weeks|Number of treatment sessions attended|weeks 9 - 12|||treatment days||Standard Deviation|Mean
809337|NCT01032135|Primary|Treatment Engagement|Number of treatment sessions attended|weeks 3 - 12|||treatment days||Standard Deviation|Mean
809338|NCT01032174|Secondary|Percentage of Participants Who Were 100 Percent Compliant With Prescribed Treatment Regimen|Percent compliance with the prescribed treatment regimen was calculated as 100 multiplied by (number of tablets taken by the participant divided by number of tablets prescribed). Value of 1 was reported if percent compliance equals to 100, and 0 if percent compliance was non-missing and less than 100.|Day 11|The FAS population included all participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy evaluation.||Percentage of Participants|||Number
809339|NCT01032174|Secondary|Percent Compliance With Prescribed Treatment Regimen|Percent compliance with the prescribed treatment regimen was calculated as 100 multiplied by (number of tablets taken by the participant divided by number of tablets prescribed).|Day 11|The FAS population included all participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy evaluation.||Percent compliance||Standard Deviation|Mean
809340|NCT01032174|Primary|Percentage of Participants With Response of Very Convenient or Somewhat Convenient|Participant reported outcome questionnaire was the assessment of participant’s convenience with drug treatment based on following categories: very convenient or somewhat convenient and not convenient or not at all convenient. Value of 1 was reported if participant answered ‘very convenient’ or ‘somewhat convenient’ and 0 if participant answered ‘not convenient’ or ‘not at all convenient’.|Day 11|The Full Analysis Set (FAS) population included all participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy evaluation. 'N' signifies number of participants with non-missing data. Missing observations were not imputed.||Percentage of Participants|||Number
809341|NCT01032200|Secondary|HVLT-IR|HVLT-IR is the Hopkins Verbal learning test - immediate recall. Participants are given 12 words to remember. They are then asked to recall those words. This is repeated 3 times. The HVLT-IR score is the sum of correctly recalled words across the three trials. Higher scores indicate better recall.|4 weeks post-RT|Participants with any data||number of correctly recalled words||Standard Error|Least Squares Mean
809342|NCT01032200|Secondary|Sleepiness|Sleepiness as measured by the Epworth Sleep Scale. It consists of 8 questions that measure daytime sleepiness in which the patient records their likelihood of dozing or sleeping during a number of routine daily activities. ESS scores range from 0 to 24. Higher scores denote greater sleepiness.|4 weeks post-RT|Participants with any data||units on a scale||Standard Error|Least Squares Mean
809343|NCT01032200|Secondary|Fatigue|Fatigue is measured by the fatigue subscale of the Functional Assessment of Chronic Illness Therapy Questionnaire. It consists of 13 questions each answered on a 0 to 4 scale. The fatigue score is the sum of the responses with some questions reverse scored. Higher scores indicate less fatigue.|4 weeks post-RT|Participants with any data||units on a scale||Standard Error|Least Squares Mean
809344|NCT01032200|Primary|Adherence|Adherence is the percentage of ideal number of pills taken while on study (based on returned diaries)|4 weeks post-RT (approximately 3 months post randomization)|Participants who returned pill diaries||percentage of ideal number of pills||Full Range|Mean
809345|NCT01032200|Primary|Retention|Retention is defined as the percentage of participants who complete the 4 week post-RT questionnaires.|4 weeks post-RT (approximately 3 months post randomization)|All randomized participants||percentage of participants|||Number
809346|NCT01032265|Secondary|Patient`s Global Impression of Improvement Scale (PGI-I)||4 months|Intention-to-treat||participants|||Number
809347|NCT01032265|Secondary|Incontinence Episode Frequency (IEF)|number of incontinence episodes per week|baseline, 4 months|Intention-to-treat||episodes per week||Standard Deviation|Mean
809348|NCT01032265|Secondary|Patient Satisfaction||4 months|Intention-to-treat||participants|||Number
809349|NCT01032265|Secondary|Usage of Incontinence Aids|Only those using incontinence aids at baseline were included in the analysis.|baseline, 4 months|Intention-to-treat||participants|||Number
809350|NCT01032265|Secondary|EuroQol Five Dimensions Visual Analogue Scale (EQ5D-VAS)|health-specific quality of life, range 0-100, higher scores indicate better quality of life.|baseline, 4 months|Intention-to-treat||units on a scale||Standard Deviation|Mean
809351|NCT01032265|Primary|International Consultation on Incontinence Modular Questionnaire Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol)|condition-specific quality of life, summed score, range 19-76, higher scores indicate greater impact on quality of life.|baseline, 4 months|Intention-to-treat||units on a scale||Standard Deviation|Mean
809352|NCT01032265|Primary|International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF)|summed symptom-score, range 0–21, with higher scores indicating greater severity.|baseline, 4 months|Intention-to-treat||units on a scale||Standard Deviation|Mean
809370|NCT01032382|Secondary|Detectable Paromomycin Plasma Levels|Paromomycin plasma concentrations following administration of paromomycin alone or WR 279,396 in adults|Day 4, 7, 12, 17, 20, 28|Adults (18+ years)||ng/mL||Standard Deviation|Mean
809353|NCT01032291|Primary|Percentage of Participants With a Response to Treatment During the Proof of Concept Period|"Tumor response was evaluated every 2 cycles beginning with Cycle 3 Day 1 and at treatment discontinuation. Response and progression were evaluated using the RECIST 1.1 criteria (Eisenhauer, 2009).
Treatment response includes both complete response and partial response.
Complete response-disappearance of all lesions
Partial response-30% decrease in the sum of diameters of target lesions from baseline
Analysis was not performed due to the early termination of the study."|week 9 up to week 24|Efficacy Evaluable Population. Analysis was not performed due to the early termination of the study.|||||
809354|NCT01032291|Secondary|Participants With Treatment-Emergent Adverse Events (TEAE)|TEAEs are any adverse event occurring or worsening on or after the first treatment of any study drug and within 28 days after the last dose of the last study drug received. Relation to study drug was determined by the investigator. Severity of AE is graded according to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.0. Severity is a 5-point scale: 3= severe or medically significant but not life-threatening 4=life-threatening, urgent intervention required 5=death related to AE.|up to week 28|Participants who took at least one dose of study treatment.||participants|||Number
809355|NCT01032291|Secondary|Kaplan-Meier Estimates for Overall Survival|"Overall survival was defined as the time between randomization and death. It was intended that participants would be followed for up to 5 years following discontinuation from treatment.
Analysis was not performed due to the early termination of the study."|up to 5.5 years|Participants who took at least one dose of study treatment. Analysis was not performed due to the early termination of the study.|||||
809356|NCT01032291|Secondary|Percentage of Participants With Disease Control|"Known as the Disease Control Rate (DCR), participants with a complete response, partial response or stable disease contribute to the DCR.
This analysis was not performed due to the early termination of the study."|up to week 24|Participants who took at least one dose of study treatment. Analysis was not performed due to the early termination of the study.|||||
809357|NCT01032291|Secondary|Kaplan-Meier Estimates for Duration of Response|"Duration of response was defined as the time from the initial response date to progressive disease (PD) for participants who achieved an objective confirmed complete response (CR) or partial response (PR).
Analysis was not performed due to the early termination of the study."|up to week 24|Participants who took at least one dose of study treatment. Analysis was not performed due to the early termination of the study.|||||
809358|NCT01032291|Secondary|Kaplan-Meier Estimates for Progression Free Survival (PFS)|"PFS was calculated as the time from randomization to the earlier of the first documentation of progressive disease (PD), or death on study due to any cause.
Analysis was not performed due to the early termination of the study."|up to week 24|Participants who took at least one dose of study treatment. Analysis was not performed due to the early termination of the study.|||||
809359|NCT01032291|Post-Hoc|Best Overall Response Assessed by an Independent Review Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1) During the Proof of Concept Period Prior to Early Study Termination|"Tumor response was evaluated every 2 cycles beginning with Cycle 3 Day 1 and at treatment discontinuation. Response and progression were evaluated using the RECIST 1.1 criteria (Eisenhauer, 2009).
Complete response-disappearance of all lesions
Partial response-30% decrease in the sum of diameters of target lesions from baseline
Stable disease-neither shrinkage nor increase of lesions.
Progressive Disease-20% increase in the sum of diameters of target lesions from nadir.
Participants with evidence of objective tumor response have the response confirmed with repeat assessments performed at the next scheduled scan."|Week 9 up to week 24|Intent to treat population.||participants|||Number
809360|NCT01032291|Primary|Participants With Dose Limiting Toxicities (DLTs) During the First Treatment Cycle of the Safety Lead-In Period|"The number of participants with DLTs determines the maximum tolerated dose of the combination therapy used in the Proof of Concept (POC) period:
If <2 of the initial 6 participants experience a DLT, then the POC will start with lenalidomide at 25 mg.
If ≥2 of the initial 6 participants experienced a DLT, then 6 more subjects were to be enrolled at 20 mg lenalidomide.
If <2 of the additional 6 subjects experienced a DLT, then the lenalidomide starting dose for the POC was to be 20 mg.
If ≥2 of the additional 6 subjects experienced a DLT, then 6 more subjects were to be enrolled at 15 mg lenalidomide.
If <2 of the additional 6 subjects experienced a DLT, then the POC was to start with lenalidomide at 15 mg.
If ≥2 of the additional 6 subjects experienced a DLT, the dosing for the study was to be reassessed by Celgene Corporation and the investigators."|Up to Day 28 (Cycle 1)|All participants who took at least one dose of study medication. If a participant discontinued the study prior to completing the entire first cycle for reasons other than a DLT or if ≥7 days of lenalidomide and/or ≥1 dose of cetuximab were missed during the first cycle for reasons other than a DLT, a replacement would be added at that dose level.||participants|||Number
809361|NCT01032382|Secondary|Number of Index Lesions Meeting Criteria for Clinical Cure During the Study|Number of study participants who meet the criteria for clinical cure (100% re-epithelialization) at specified timepoints during the study.|Day 1, 4, 7, 12, 17, 20, 28, 35, 42, 49, 56, 63, 100, 168|||Lesions meeting clinical cure criteria|||Number
809362|NCT01032382|Secondary|Final Clinical Cure on All Lesions Independent of Subjects|"Final clinical cure was defined as follows:
Subject has initial clinical cure (100% re-epithelialization of lesion by nominal Day 63); OR,
Subject has initial clinical improvement (> 50% re-epithelialization of lesion by nominal Day 63 followed by 100% re-epithelialization of the lesion on or before nominal Day 100; AND,
Subject has no relapse of lesion by Day 168. Relapse was defined as a lesion meeting the criteria for initial clinical cure that had any new ulceration/nodule (> 0 x 0 mm measurement) by nominal day 168, or a lesion meeting the criteria for initial clinical improvement that subsequently enlarged by nominal Day 168."|Initial clinical cure by day 63 and no relapse by day 168|||Cured ulcerated lesions|Participants||Number
809363|NCT01032382|Secondary|Pharmacokinetic Parameter: AUC/D|Area under the plasma concentration-time curve over 24 hrs divided by topical dose (AUC/D) of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama|Days 1 and 20|Adults (18+ years)||hr/ML||Standard Deviation|Mean
809364|NCT01032382|Secondary|Pharmacokinetic Parameter: Cmax/D|Maximum observed plasma concentration divide by topical dose (Cmax/D) of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama|0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20|Adults (18+ years)||1/ML||Standard Deviation|Mean
824696|NCT01184079|Secondary|Compliance With 3rd Dose|Determine the compliance of the men for the timing of the third dose.|at 3rd dose (i.e., at month 6 or month 12, depending on arm)|||participants|||Number
809371|NCT01032382|Primary|Final Clinical Cure for Index Lesions|"Final clinical cure was defined as follows:
Subject has initial clinical cure (100% re-epithelialization of index lesion by nominal Day 63); OR,
Subject has initial clinical improvement (> 50% re-epithelialization of index lesion by nominal Day 63 followed by 100% re-epithelialization of the index lesion on or before nominal Day 100; AND,
Subject has no relapse of index lesion by Day 168. Relapse was defined as an index lesion meeting the criteria for initial clinical cure that had any new ulceration/nodule (> 0 x 0 mm measurement) by nominal day 168, or an index lesion meeting the criteria for initial clinical improvement that subsequently enlarged by nominal Day 168."|Initial clinical cure by day 63 and no relapse by day 168|||participants|||Number
809372|NCT01032538|Secondary|Oxford Knee Score||10 years postoperatively||||||
809373|NCT01032538|Secondary|Knee Injury and Osteoarthritis Outcome Score||10 years postoperatively||||||
809374|NCT01032538|Secondary|UCLA Score||Preoperative until 2 years postoperatively||||||
809375|NCT01032538|Secondary|Oxford Knee Score||Preoperative until 2 years postoperatively||||||
809376|NCT01032538|Secondary|Range of Motion||Preoperative until 2 years postoperatively|||degrees||95% Confidence Interval|Mean
809377|NCT01032538|Primary|Knee Injury and Osteoarthritis Outcome Score|Patient relevant knee score. Validated score with 5 arms. 0-100, 100 is best.|Preoperative until 2 years postoperatively|||units on a scale||95% Confidence Interval|Mean
809378|NCT01032694|Secondary|Percentage of Participants Who Were 100 Percent Compliant With Prescribed Treatment Regimen|Percent compliance with the prescribed treatment regimen was calculated as 100 multiplied by (number of tablets taken by the participant divided by number of tablets prescribed). Value of 1 was reported if percent compliance equals to 100, and 0 if percent compliance was non-missing and less than 100.|Days 11-12|The FAS population included all participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy evaluation.||Percentage of Participants|||Number
809379|NCT01032694|Secondary|Percent Compliance With the Prescribed Treatment Regimen|Percent compliance with the prescribed treatment regimen was calculated as 100 multiplied by (number of tablets taken by the participant divided by number of tablets prescribed).|Days 11-12|The FAS population included all participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy evaluation.||Percent compliance||Standard Deviation|Mean
809380|NCT01032694|Primary|Percentage of Participants With Response of Very Convenient or Somewhat Convenient|Participant reported outcome questionnaire was the assessment of participant’s convenience with drug treatment based on following categories: very convenient or somewhat convenient and not convenient or not at all convenient. Value of 1 was reported if participant answered ‘very convenient’ or ‘somewhat convenient’ and 0 if participant answered ‘not convenient’ or ‘not at all convenient’.|Days 11-12|The Full Analysis Set (FAS) population included all participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy evaluation. Missing observations were not imputed. 'N' signifies the number of participants with non-missing data.||Percentage of Participants|||Number
809381|NCT01032733|Secondary|Mitochondrial Function (Cox IV Subunit)|Western blot analysis was performed to determine complex content. The amount of Cox IV subunit was determined for each Reporting Group via Western Blot analysis at baseline and week 24.|24 weeks|Change from baseline (e.g., baseline and 24 weeks) was defined as the value at time t minus the value observed at baseline for all response measures. In addition, the discrepancy for the number of participants is becasue we could only obtain information on a subset of participants due to the nature of the procedure (muscule biopsy).||fold change (ug/ml)||Standard Deviation|Mean
809382|NCT01032733|Secondary|Knee Extension Maximum Isokinetic Strength (Weight Lifted in Kilograms).|Maximal knee extension strength using each participant’s strongest leg was measured using a Biodex. The participants were asked to develop their maximal isokinetic knee extension strength. Three trials of 5 repetitions were performed and the peak torque value was used for statistical analyses.|24 weeks|Change from baseline (e.g., baseline and 24 weeks) was defined as the value at time t minus the value observed at baseline for all response measures.||kilograms||Standard Deviation|Mean
809383|NCT01032733|Secondary|Short Physical Performance Battery|Scores on the Short Physical Performance Battery (SPPB) were obtained at baseline and at the 24-week post-treatment assessment visit. The SPPB consists of a 4 meter walk, repeated chair stands, and three hierarchical standing balance tests. The time to complete each of the three performance measures was assigned a categorical score based on normative data, ranging from 0 to 4. A summary score ranging from 0 (worst performers) to 12 (best performers) was calculated by adding walking speed, chair stands, and balance scores.|24 weeks|Change from baseline (e.g., baseline and 24 weeks) was defined as the value at time t minus the value observed at baseline for all response measures.||score on the SPPB||Standard Deviation|Mean
809384|NCT01032733|Secondary|Body Weight|Body weight was measured under fasting conditions following voiding in the morning at baseline and at the 24-week post-treatment assessment.|24 weeks|Change from baseline (e.g., baseline and 24 weeks) was defined as the value at time t minus the value observed at baseline for all response measures. The five imputed responses sampled from a normal distribution with the mean baseline value (so 'centered' with a baseline carried forward mechanism).||kilograms||Standard Deviation|Mean
809385|NCT01032733|Primary|Performance on the 400 Meter Walk|Walking speed was assessed at baseline and 24-week assessment by the 400 Meter Walk Test, during which participants were asked to complete a standard walking course at their usual pace. Participants were permitted to stop during the walk but were not allowed to sit or receive help from others and were required to complete the course in 15 minutes.|24 weeks|Change from baseline (e.g., baseline and 24 weeks) was defined as the value at time t minus the value observed at baseline for all response measures. The five imputed responses sampled from a normal distribution with the mean baseline value (so ‘centered’ with a baseline carried forward mechanism).||meters per second||Standard Deviation|Mean
809386|NCT01032759|Secondary|Chronic Post-surgical Pain||1 month, 3 month, 6 month|Data was not collected and therefore not analyzed.|||||
809387|NCT01032759|Secondary|Patient Satisfaction|"Number of participants who reported very satisfied or somewhat satisfied"|48 hours|Number of participants who had this outcome reported and documented.||participants|||Number
810403|NCT01044732|Primary|Detection Rates for Adenomas and for Total Polyps|Numbers of polyps and adenomas detected in first and second procedures for each group|Acute - subjects were followed for the duration of the procedures, an average of 40 minutes.|Per-protocol population||Polyps or adenomas detected|||Number
809388|NCT01032759|Secondary|Hyperalgesia|Stimulation with a Von Frey hair filament at 396 mN of force will be started from outside the hyperalgesic area, where no pain sensation is experienced toward the incision until the patient reports a distinct change in perception. The first point where a “painful,” “sore,” or “sharper” feeling occurs will be marked, and the distance to the incision measured. The surface area will be measured in cm2 around the surgical incision.|Within 48 h|Number of participants who had this outcome measured and documented||cm2||Standard Deviation|Mean
809389|NCT01032759|Secondary|Opioid Related Side Effects: Pruritus|Number of participants who experienced pruritus.|0-24 h|||participants|||Number
809390|NCT01032759|Secondary|Opioid Related Side Effects|Number of participants with postoperative nausea and vomiting.|0-24 h|||participants|||Number
809391|NCT01032759|Primary|24 hr Opioid Consumption||24 hr|Participants who completed the 24 hour assessment.||mg morphine equivalents||Standard Deviation|Mean
809392|NCT01032759|Secondary|Pain Scores|Pain score (0=no pain, 10= worst possible pain)|48 hours|Participants who completed the 48 hour assessment.||units on a scale||Standard Deviation|Mean
809393|NCT01032837|Secondary|Number of Participants Who Developed Secondary Illnesses That Were Treated With Antibiotics|The number of participants who developed secondary illnesses due to influenza, including otitis media, bronchitis, pneumonia, or sinusitis at any time during the study which were treated with antibiotics.|Day 1 through Day 40|ITTI population||participants|||Number
809394|NCT01032837|Secondary|Number of Participants Who Developed Secondary Illnesses During the Study|The number of participants who developed secondary illnesses due to influenza, including four pre-defined adverse events: otitis media, bronchitis, pneumonia, or sinusitis at any time during the study.|Day 1 through Day 40|ITTI population||participants|||Number
809395|NCT01032837|Secondary|Time to Alleviation of All Clinical Symptoms - Adults|Daily influenza-like symptoms (such as nasal congestion, sore throat, cough, aches and pains, fatigue, headache, chills) were recorded in a diary on a scale from 0 (absent) to 3 (severe). A patient is considered free of all clinical influenza symptoms if all symptoms were checked as 'absent' or 'mild' (i.e., symptom score ≤1). Time to alleviation of all clinical symptoms was defined as the number of hours from the first dose to the first time the patient had alleviation of all symptoms. Patients without alleviation of symptoms were censored at the last available assessment.|Day 1 to Day 40|ITTI population including adults only (>12 years old).||hours||95% Confidence Interval|Median
809396|NCT01032837|Secondary|Time to Alleviation of All Clinical Symptoms - Children|Daily influenza-like symptoms (such as poor appetite, irritability, low energy, nasal congestion, runny nose etc) were recorded in a diary on a scale from 0 (no problem) to 3 (major problem). A patient is considered free of all clinical influenza symptoms if all symptoms were checked as 'no problem' or 'minor problem' (i.e., symptom score ≤1). Time to alleviation of all clinical symptoms was defined as the number of hours from the first dose to the first time the patient had alleviation of all symptoms. Patients without alleviation of symptoms were censored at the last available assessment.|Day 1 to Day 40|ITTI population including children only (ages 1 - 12 years).||hours||95% Confidence Interval|Median
809397|NCT01032837|Secondary|Time to Resolution of Fever|Temperature was recorded by the patient in a diary twice daily for 10 days and once daily thereafter. Fever was defined as a body temperature greater than or including 37.8 degrees Celsius (or ≥ 100.04 Fahrenheit). Time to resolution of fever was defined as the total number of hours from the first dose of study medication to the first time at which temperature is ≤ 37.2 degrees Celsius and lasts at least 21.5 hours. Patients who were still febrile at the end of the study period were censored at that time.|Day 1 through Day 40|ITTI population with fever at Baseline.||hours||95% Confidence Interval|Median
809398|NCT01032837|Secondary|Number of Participants With Development of Oseltamivir-Resistant Influenza Virus|The last positive viral isolate from each patient was tested for reduced sensitivity to oseltamivir. Phenotypic assay was performed to determine the susceptibility of the last positive viral isolate from each patient. If required, a genotypic assay to determine the contribution of both the neuraminidase (NA) and hemagglutinin (HA) genes to decreased susceptibility was also performed.|40 days|ITTI Population||participants|||Number
809399|NCT01032837|Secondary|Change From Baseline in Influenza Titer Measured by Viral Culture|Influenza virus titer measured by viral culture and expressed on a Log10 scale of the 50% Tissue Culture Infective Dose (TCID50; amount of virus required to kill 50% of inoculated tissue culture cells).|Baseline, Days 2 through 15|ITTI||Log10 TCID50||Standard Deviation|Mean
809400|NCT01032837|Secondary|Percentage of Participants With Viral Shedding by Clinic Visit as Measured by Reverse Transcriptase Polymerase Chain Reaction|Viral shedding was measured by reverse transcriptase polymerase chain reaction (RT-PCR) from samples obtained from nasal and throat swabs and performed by the central laboratory.|Baseline and Days 3, 6, 8, 11, 15 and 40|ITTI||percentage of participants|||Number
809401|NCT01032837|Secondary|Percentage of Participants With Viral Shedding by Clinic Visit as Measured by Viral Culture|Viral shedding was measured by viral culture from samples obtained from nasal and throat swabs and performed by the central laboratory.|Baseline and Days 3, 6, 8, 11, 15 and 40|ITTI||percentage of participants|||Number
809402|NCT01032837|Primary|Time to Cessation of Viral Shedding|The time to cessation of viral shedding was measured by viral culture and defined as the time from treatment initiation to the time of the first negative culture with no subsequent positive cultures. Any patient with a positive culture at the last sample time was censored at that time point. Median time to cessation was estimated from the Kaplan-Meier curve.|Day 1 to Day 40|ITT infected (ITTI) Population, including all patients randomized who received at least one dose of study medication with laboratory confirmation of pandemic (H1N1) 2009 influenza infection, excluding patients infected with oseltamivir-resistant influenza A H1N1 H275Y at baseline and patients not shedding virus at baseline.||hours||95% Confidence Interval|Median
809427|NCT01033032|Primary|Progression-free Survival (PFS)|Progression-free survival is measured from Day 1 of study drug administration to disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death on study. Progression is defined in RECIST v1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|every 6 weeks until progressive disease|Includes patients treated at the MTD (Dose Level 3)||months||95% Confidence Interval|Median
810520|NCT01052480|Secondary|Duration of Supplemental Oxygen|Duration of supplemental oxygen use in days|Measured from Day 0 through Day 28|The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza.||days||Inter-Quartile Range|Median
809403|NCT01032850|Secondary|Progression Free Survival (PFS)|The time from treatment initiation to disease progression or death by any cause. Progression is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI:) Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|5 years|||months||95% Confidence Interval|Median
809404|NCT01032850|Secondary|Overall Survival (OS)|The time from treatment initiation to death by any cause|5 years|||Months||95% Confidence Interval|Median
809405|NCT01032850|Secondary|Disease Control Rate of Response (DCR)|Tumor response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI:) Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Disease control rate (DCR) is the sum of the percentages of patients achieving complete and partial responses and stable disease|6 months|||percentage of participants|||Number
809406|NCT01032850|Primary|Number of Participants Experiencing Adverse Events|The primary objective of the study is to evaluate safety and tolerability of the study treatment regimen. The analyses will be descriptive and no formal hypotheses testing will be performed. Toxicities (i.e. Adverse Events) are evaluated prior to each treatment and during any clinical visit.|6 months|||participants|||Number
809407|NCT01032889|Secondary|Change From Baseline in Submental Fat Thickness|Submental fat thickness was measured by magnetic resonance imaging (MRI).|Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)|Modified intent-to-treat population; LOCF method was used to impute missing data.||mm||95% Confidence Interval|Least Squares Mean
809408|NCT01032889|Secondary|Change From Baseline in Submental Fat Volume|Submental fat volume was measured by magnetic resonance imaging (MRI).|Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)|Modified intent-to-treat population; LOCF method was used to impute missing data.||mm³||95% Confidence Interval|Least Squares Mean
809409|NCT01032889|Primary|Change From Baseline in Patient-Reported Submental Fat Impact Scale (PR-SMFIS)|The PR-SMFIS assesses the impact of submental fat on self-perception of 6 emotional and visual characteristics related to the appearance of submental fullness (unhappy, bothered, self-conscious, embarrassed, look older, and look overweight) as evaluated by the participant. Each item is rated on an 11-point numeric scale from 0 to 10. Scores for the 6 items were averaged to generate a PR-SMFIS total scale score ranging from 0 to 10 where 0 is a positive outcome and 10 is a negative outcome. A negative change from Baseline indicates improvement.|Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)|Modified intent-to-treat population with available Baseline data; LOCF method was used to impute missing data.||units on a scale||95% Confidence Interval|Least Squares Mean
809410|NCT01032889|Primary|Change From Baseline in Patient-Reported Submental Fat Scale Rating Scale (PR-SMFRS)|"The PR-SMFRS is based on the participant's response to the question How much fat do you have under your chin right now? answered on a 5-point ordinal scale (0-4) with 0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat. A negative change from Baseline indicates improvement."|Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)|Modified intent-to-treat population with available Baseline data; LOCF method was used to impute missing data.||units on a scale||95% Confidence Interval|Least Squares Mean
809411|NCT01032889|Primary|Change From Baseline in Clinician-Reported Submental Fat Rating Scale Scores|The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme. A negative change from Baseline indicates improvement.|Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)|Modified Intent-to-Treat (mITT) population including all randomized participants who received at least 1 injection of study drug and had at least 1 post-baseline observation for CR-SMFRS, Subject Self-Rating Scale (SSRS), or magnetic resonance imaging (MRI) volume. Last observation carried forward (LOCF) method was used to impute missing data.||units on a scale||95% Confidence Interval|Least Squares Mean
809412|NCT01032915|Secondary|Mean Change in Vitreous Haze Grade From Baseline to 24 Weeks|The changes in steps (0, 1, or >= 2) from previous visit for vitreous haze, where the score is evaluated based on NEI Vitreous Haze Grading Scale (0 -4). Vitreous haze was recorded as 0-clear; to 4+ as dense opacity obscuring the optic nerve head. A 1 step increase is defined as any of the following changes: 0-1, 0.5-1, 1-2, 2-3, 3-4. A 2 step increase is defined as any of the following changes: 0-2, 0.5-2, 1-3, 2-4. A recurrent episode of active intermediate, posterior or panuveitis was considered to be resolved, if the eye returns and maintains in a quiescent state (<1+ anterior chamber cell grade and <1+ vitreous haze) for at least 2 weeks|Baseline to 24 weeks|Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and have at least one post-baseline assessment for the primary efficacy parameter or any of its components. Following the intent-to-treat principle, patients were analyzed according to the treatment they are assigned to at randomization.||Score||Standard Deviation|Mean
809413|NCT01032915|Secondary|Mean Change in Best Corrected Visual Acuity From Baseline|The Best Corrected Visual Acuity (BCVA) is tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) testing protocol. VA measurements are taken in a sitting position at an initial test distance of 4 meters using ETDRS charts. The overall BCVA score is calculated using the BCVA worksheet 0-100 letter score.|Baseline to 24 weeks|Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and have at least one post-baseline assessment for the primary efficacy parameter or any of its components. Following the intent-to-treat principle, patients were analyzed according to the treatment they are assigned to at randomization.||Letters||Standard Deviation|Mean
809414|NCT01032915|Secondary|Change (Reduction) From Baseline in Composite Immunosuppressive Medication Score (IMS) From Baseline to 24 Weeks|Participants could have received up to 5 immunosuppresive agents (prednisone, cyclosporine, azathioprine, methotrexate, mycophenolate). Immunosuppressive Medication Score (IMS) is a combined, single numeric score derived on basis of total daily dose of specific immunosuppressive agents / unit body weight, ranged on a scale from 0-9 for the total daily dose in mg per kg. Patients receiving multiple medications, the sum of the grading scores for each drug was used to calculate a total immunosuppression score at each visit. The total IMS is the sum of scores derived from the agents included into the score, and ranged from 0 to 55. Treatment groups compared using analysis of covariance with treatment & baseline IMS as covariate, where the lower IMS (or its reduction from baseline) showed better clinical outcome|Baseline to 24 weeks|Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and have at least one post-baseline assessment for the primary efficacy parameter or any of its components. Following the intent-to-treat principle, patients were analyzed according to the treatment they are assigned to at randomization.||Score||Standard Deviation|Mean
809415|NCT01032915|Primary|Time to First Recurrence in Any Eye of Active Intermediate, Posterior, or Panuveitis From Baseline|Kaplan-Meier estimates for the time to the first recurrence in any eye of active intermediate, posterior, or panuveitis from baselineRecurrence of active intermediate, posterior, or panuveitis defined by either: ≥ 2 step increase in vitreous haze with or without an increase in anterior chamber cell grade or decrease in best corrected visual acuity of ≥ 10 ETDRS letters|Baseline to 24 weeks|Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and have at least one post-baseline assessment for the primary efficacy parameter or any of its components. Following the intent-to-treat principle, patients were analyzed according to the treatment they are assigned to at randomization.||Days||95% Confidence Interval|Median
809416|NCT01032928|Primary|Optimal Respiratory - Swallow Phase|Respiratory swallow patterns were collected using nasal airflow and respiratory inductance plethysmography (RIP) of each swallow during the modified barium swallow study. The movements of the ribcage and abdomen were recorded using RIP; data synchronized and recorded using the KayPentax Digital Swallow Workstation Signals Lab. Subjects were categorized as optimal (expiratory-expiratory) versus non-optimal (non-expiratory-expiratory).|Patient were assessed pre-treatment, one week post treatment and one month post treatment. Treatment sessions were twice weekly for up to 4 weeks|||percentage of swallows|||Number
809417|NCT01032928|Secondary|Percentage of Impairment According to the Penetration-Aspiration Scale|The penetration aspiration scale is a validated 8 point interval scale used to describe penetration and aspiration events. Scores are determined primarily by the depth to which material passes in the airway and by whether or not material entering the airway is expelled. Scores < 3 are considered to be normal. For the purpose of our study scores were dichotimized to normal and impaired.|Patient were assessed pre-treatment, one week post treatment and one month post treatment. Treatment sessions were twice weekly for up to 4 weeks|||percentage of swallows with impaired PAS|||Number
809418|NCT01032928|Secondary|Percentage of Impairment According to the Modified Barium Swallow Impairment Profile (MBSImP)|Analysis of the percentage of impaired swallow components using a dichotomized MBSImP scoring system|Patient were assessed pre-treatment, one week post treatment and one month post treatment. Treatment sessions were twice weekly for up to 4 weeks|||percentage of impairment|||Number
809419|NCT01032993|Secondary|Percentage of Participants With Adverse Effects|serious adverse effects and possible side effects were tracked through all phases of the study by participant interview and checklist at each visit, up to 4 weeks.|4 weeks|3 serious adverse events occurred during the study that were judged unrelated to the study: specifically, 3 participants were hospitalized prior to randomization, 1 for pneumonia; 1 for a back injury; and 1 for a mental health condition. All recovered. There were no SAE during the randomization period. Non serious AEs are listed below.||% of participants reporting|||Number
809420|NCT01032993|Secondary|Percentage of Participants With Improvement in Disability Related to Muscle Pain|Disability improvement was based on patient report of improvement they felt was meaningful to them|4 weeks|||% reporting improved function|||Number
809421|NCT01032993|Secondary|Continuation of Statin|Adherence of statin use was defined a priori as participant using Simvastatin 20 mg /day at the end of 4 weeks and having used >85% of statin doses.|4 weeks|||participants|||Number
809422|NCT01032993|Primary|Percentage of Participants With Reduction in Muscle Pain Associated With Statin Use|Clinically significant pain reduction was defined, a priori, as a reduction > 1.5 points on the Brief Pain Inventory-Severity Scale (BPI-SS), range: 0 to 10|4 weeks|||% of participants with pain reduction|||Number
809423|NCT01033019|Primary|Clinical Evaluation of sBCCs Tumors|The clinical response parameters were defined as (i) complete response (i.e., there is no longer any visible evidence of a lesion consistent with BCC at this site), (ii) partial response (i.e., although a BCC still remains at this site, it has demonstrated a visible decrease in size compared with baseline), and (iii) no response / worsening (i.e., the BCC has not demonstrated any visible decrease in size compared with baseline).|Day 43|Efficacy analysis set: the efficacy analysis set included all randomized participants with evaluable data.||Participants|||Number
809424|NCT01033032|Secondary|Overall Response Rate (ORR)|The number of patients with observed complete response [CR] or partial response [PR]. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|every 6 weeks until treatment discontinuation, expected average 18 months|Includes patients treated at the MTD (Dose Level 3)||participants|||Number
809425|NCT01033032|Secondary|Overall Survival (OS)|Measured from Day 1 of study drug administration to date of death due to any cause.|every 6 weeks until treatment discontinuation, expected average of 18 months|Includes patients treated at the MTD (Dose Level 3)||months||95% Confidence Interval|Median
809426|NCT01033032|Secondary|Number of Patients With Adverse Events as a Measure of Safety and Tolerability|Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs)|every 6 weeks until treatment discontinuation, expected average 18 months|Includes patients treated at the MTD (Dose Level 3)||participants|||Number
810721|NCT01048606|Primary|Markers of Oxidative Stress: Conjugated Diene Formation, Malondialdehyde, Alpha-tocopherol and Its Oxidised Form Alpha-tocopheryl Quinone. TAS Constitutes the Most Reliable Method for the Evaluation of Oxidative Stress in Vivo.||12 months||||||
809428|NCT01033071|Secondary|Percent of Participants Who Reached Target Clinic Systolic Blood Pressure of <140 mm Hg and/or Reduction of ≥20 mm Hg From Baseline and Target Clinic Diastolic Blood Pressure of <90 mm Hg and/or Reduction of ≥10 mm Hg From Baseline.|Percentage of participants who achieve both a clinic diastolic and systolic blood pressure response measured at each week indicated, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg AND less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Diastolic and systolic blood pressure is based on the arithmetic mean of the non-missing values of the 3 serial trough sitting blood pressure measurements.|Baseline, Week 4, Week 8 and Week 12.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.||percent of participants|||Number
809429|NCT01033071|Secondary|Percentage of Participants Who Reached Target Clinic Diastolic Blood Pressure of <90 mm Hg and/or Reduction of ≥10 mm Hg From Baseline.|Percentage of participants who achieve a clinic diastolic blood pressure response measured at each week indicated, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg. Diastolic blood pressure is the arithmetic mean of the non-missing values of the 3 serial trough sitting diastolic blood pressure measurements.|Baseline, Week 4, Week 8 and Week 12.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.||percentage of participants|||Number
809430|NCT01033071|Secondary|Percentage of Participants Who Reached Target Clinic Systolic Blood Pressure of <140 mm Hg and/or Reduction of ≥20 mm Hg From Baseline.|Percentage of participants who achieve a clinic systolic blood pressure response measured at each week indicated, defined as less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Systolic blood pressure is the arithmetic mean of the non-missing values of the 3serial trough sitting systolic blood pressure measurements.|Baseline, Week 4, Week 8 and Week 12.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.||percentage of participants|||Number
809431|NCT01033071|Secondary|Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring.|The change from baseline for each hour interval of the 24-hour ambulatory blood pressure monitoring measured at week 12 or final visit. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The mean consists of the average (arithmetic mean) of measurements collected at each hour.|Baseline and Week 12.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
809432|NCT01033071|Secondary|Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring.|The change from baseline for each hour interval of the 24-hour ambulatory blood pressure monitoring measured at week 12 or final visit. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The mean consists of the average (arithmetic mean) of measurements collected at each hour.|Baseline and Week 12.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
809433|NCT01033071|Secondary|Change From Baseline in the Mean Diastolic Blood Pressure at 0 to 12 Hours After Dosing by Ambulatory Blood Pressure Monitoring.|The change in the mean 12 hour diastolic blood pressure measured at week 12 or final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The mean consists of the average (arithmetic mean) of measurements.|Baseline and Week 12.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
809434|NCT01033071|Secondary|Change From Baseline in the Mean Systolic Blood Pressure at 0 to 12 Hours After Dosing by Ambulatory Blood Pressure Monitoring.|The change in the mean 12 hour systolic blood pressure measured at week 12 or final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The mean consists of the average (arithmetic mean) of measurements.|Baseline and Week 12.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
809435|NCT01033071|Secondary|Change From Baseline in Mean Nighttime (12 AM to 6 AM) Diastolic Blood Pressure by Ambulatory Blood Pressure Monitoring.|The change in the mean nighttime (12am to 6am) diastolic blood pressure measured at week 12 or final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Mean nighttime is the average (arithmetic mean) of measurements recorded between the hours of 12 AM (inclusive) and 6 AM (exclusive).|Baseline and Week 12.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
809436|NCT01033071|Secondary|Change From Baseline in Mean Nighttime (12 AM to 6 AM) Systolic Blood Pressure by Ambulatory Blood Pressure Monitoring.|The change in the mean nighttime (12am to 6am) systolic blood pressure measured at week 12 or final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Mean nighttime is the average (arithmetic mean) of measurements recorded between the hours of 12 AM (inclusive) and 6 AM (exclusive).|Baseline and Week 12.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
809437|NCT01033071|Secondary|Change From Baseline in Mean Daytime (6 AM to 10 PM) Diastolic Blood Pressure by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean diastolic blood pressure measured at week 12 or final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 AM (inclusive) and 10 PM (exclusive).|Baseline and Week 12.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
809438|NCT01033071|Secondary|Change From Baseline in Mean Daytime (6 AM to 10 PM) Systolic Blood Pressure by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean systolic blood pressure measured at week 12 or final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 AM (inclusive) and 10 PM (exclusive).|Baseline and Week 12.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
809439|NCT01033071|Secondary|Change From Baseline in 24-hour Mean Diastolic Blood Pressure by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean diastolic blood pressure measured at week 12 or final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 12.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
809440|NCT01033071|Secondary|Change From Baseline in 24-hour Mean Systolic Blood Pressure by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean systolic blood pressure measured at week 12 or final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 12.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
809441|NCT01033071|Secondary|Change From Baseline in Mean Trough Diastolic Blood Pressure by Ambulatory Blood Pressure Monitoring.|The change in trough diastolic blood pressure measured at week 12 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Trough is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 12.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
809442|NCT01033071|Secondary|Change From Baseline in Mean Trough Systolic Blood Pressure by Ambulatory Blood Pressure Monitoring.|The change in trough systolic blood pressure measured at week 12 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Trough is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 12.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
809443|NCT01033071|Secondary|Change From Baseline in Trough, Sitting, Clinic Diastolic Blood Pressure.|The change in sitting trough clinic diastolic blood pressure measured at each week indicated relative to baseline. Trough blood pressure is the average (arithmetic mean) of the non-missing values of the 3 serial trough sitting systolic blood pressure measurements.|Baseline, Week 4, Week 8 and Week 12.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
809444|NCT01033071|Secondary|Change From Baseline in Trough, Sitting, Clinic Systolic Blood Pressure.|The change in sitting trough clinic systolic blood pressure measured at each week indicated relative to baseline. Trough blood pressure is the average of the non-missing values of the 3 serial trough sitting systolic blood pressure measurements.|Baseline, Week 4 and Week 8.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
809445|NCT01033071|Primary|Change From Baseline in Trough, Sitting, Clinic Systolic Blood Pressure.|The change in sitting trough clinic systolic blood pressure measured at week 12 or final visit relative to baseline. Trough blood pressure is the average of the non-missing values of the 3 serial trough sitting systolic blood pressure measurements.|Baseline and Week 12.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
809448|NCT01040351|Secondary|The Number of Participants Who Achieved Ongoing Pregnancy in a Transfer Cycle .|The number of participants who Achieved Ongoing pregnancy (pregnancy for more than 18 weeks after embryo transfer) in a transfer cycle .|18 weeks after embryo transfer|Patients who underwent embryo transfer were included in the final analysis||participents|||Number
809449|NCT01040351|Primary|The Number of Participants Who Achieved Clinical Pregnancy in a Transfer Cycle|"The Number of Participants Who Achieved Clinical Pregnancy( presence of intrauterine gestational sac detected by transvaginal ultrasound
)in a transfer cycle"|5 weeks after embryo transfer|Patients undergoing embryo transfer were included in final analysis||participents|||Number
809450|NCT01040403|Secondary|Systolic and Diastolic Blood Pressure Recorded in Conjunction With Spirometry|Systolic and diastolic blood pressure recorded in conjunction with spirometry change from baseline on day 29 in millimetres of mercury (mmHg).|Baseline and 30 min post-dose on day 29|TS which comprised all patients who were dispensed study medication, were documented to have taken at least 1 dose of investigational treatment and had available data for systolic and diastolic blood pressure at baseline and day 29.||mmHg||Standard Deviation|Mean
809640|NCT01036724|Primary|Total Fluoroscopy Time|The primary outcome measure of this study is to measure and compare total fluoroscopy exposure time (minutes) at the conclusion of radiofrequency ablation for the treatment of paroxysmal atrial fibrillation, when guided by the CARTO® 3 or the NavX(TM) System in similar procedures.|Throughout the Total Duration of the Procedure|||minutes||Full Range|Median
809451|NCT01040403|Secondary|Pulse Rate Recorded in Conjunction With Spirometry|Pulse rate recorded in conjunction with spirometry change from baseline at 30 minutes post-dose on day 29 in beats per minute (bpm).|Baseline and 30 min post-dose on day 29|TS which comprised all patients who were dispensed study medication, were documented to have taken at least 1 dose of investigational treatment and had available data for pulse rate at baseline and day 29.||bpm||Standard Deviation|Mean
809452|NCT01040403|Secondary|Patients Global Rating|"Adjusted means of the Global Rating of the patients' health (respiratory condition) on day 29.
The score was evaluated on a 7-point scale :
1 : very much better
2 : much better
3 : a little better
4 : no change
5 : a little worse
6 : much worse
7 : very much worse"|Day 29|FAS||units on a scale||Standard Error|Mean
809453|NCT01040403|Secondary|Physicians Global Evaluation|"Adjusted means of the Physicians Global Evaluation of the patient's respiratory condition on days 1 and 29.
The score was evaluated on a 8-points scale :
Poor : 1,2
Fair : 3,4
Good : 5,6
Excellent : 7,8"|Days 1 and 29|FAS||units on a scale||Standard Error|Mean
809454|NCT01040403|Secondary|Weekly Mean Number of Puffs of Rescue Medication Used Per Day|Adjusted means of the weekly mean number of puffs of rescue medication during the whole day : the rescue medication was a salbutamol [albuterol] dose (100 mcg per puff).|Weeks 1 and 4|FAS||number of puffs per day||Standard Error|Mean
809455|NCT01040403|Secondary|Individual PEF Measurements at Each Time Point on Day 29|Adjusted means of the PEF measurements [L/min] at each time point on day 29. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.|Baseline and 1 h, 10 min pre-dose and 0 min, 5 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h post-dose on day 29|FAS||L/min||Standard Error|Mean
809456|NCT01040403|Secondary|Individual FVC Measurements at Each Time Point on Day 29|Adjusted means of the FVC measurements [L] at each time point on day 29. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.|Baseline and 1 h, 10 min pre-dose and 0 min, 5 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h post-dose on day 29|FAS||Litres||Standard Error|Mean
809457|NCT01040403|Secondary|Individual FEV1 Measurements at Each Time Point on Day 29|Adjusted means of the FEV1 measurements [L] at each time point on day 29. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.|Baseline and 1 h, 10 min pre-dose and 0 min, 5 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h post-dose on day 29|FAS||Litres||Standard Error|Mean
809458|NCT01040403|Secondary|PEF Peak 0-3h Response After the First Dose|Adjusted means of the Peak Expiratory flow from 0 to 3 hours response in L/min after the first dose of treatment. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.|Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 1|FAS||L/min||Standard Error|Mean
809459|NCT01040403|Secondary|PEF Peak 0-3h Response|Adjusted means of the peak expiratory flow from 0 to 3 hours (PEF peak 0-3h) response in L/min after 4 weeks of treatment. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.|Baseline 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 29|FAS||L/min||Standard Error|Mean
809460|NCT01040403|Secondary|PEF AUC 0-3h Response After the First Dose|Adjusted means of the Area under the curve from 0 to 3 h response in Litres / minutes of the peak expiratory flow after the first dose, calculated using the trapezoidal rule, divided by the duration (3 hours) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.|Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 1|FAS||L/min||Standard Error|Mean
809461|NCT01040403|Secondary|PEF AUC 0-3h and AUC 0-6h Responses|Adjusted means of the Peak Expiratory Flow (PEF) AUC 0-3h and AUC 0-6h responses in Litres / minute (L/min) after 4 weeks of treatment, calculated using the trapezoidal rule, divided by the duration (3 h, 6 h) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.|Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post dose for AUC0-3h and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h 4 h, 5 h, 6 h postdose for AUC0-6h on day 29|FAS||L/min||Standard Error|Mean
809462|NCT01040403|Secondary|FVC Peak 0-3h Response After the First Dose|Adjusted mean of the FVC peak 0-3h response [L] after the first dose. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.|Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 1|FAS||Litres||Standard Error|Mean
809463|NCT01040403|Secondary|FVC Peak 0-3h Response|Adjusted means of the FVC peak 0-3h response [L] after 4 weeks of treatment. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.|Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 29|FAS||Litres||Standard Error|Mean
809464|NCT01040403|Secondary|FVC AUC 0-3h Response After First Dose|Adjusted means of the FVC AUC 0-3h response [L] after first dose, calculated using the trapezoidal rule, divided by the duration (3 hours) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.|Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on days 1|FAS||Litres||Standard Error|Mean
809465|NCT01040403|Secondary|FVC AUC 0-3h and FEV1 AUC 0-6h Responses|Adjusted means of the FVC AUC 0-3h and AUC 0-6h responses [L] after 4 weeks of treatment, calculated using the trapezoidal rule, divided by the duration (3 h, 6 h) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.|Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post dose for AUC0-3h and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h 4 h, 5 h, 6 h postdose for AUC0-6h on day 29|FAS||Litres||Standard Error|Mean
809466|NCT01040403|Secondary|FEV1 Peak 0-3h Response After the First Dose|Adjusted means of the FEV1 peak 0-3h response [L] after the first dose of treatment. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.|Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 1|FAS||Litres||Standard Error|Mean
809468|NCT01040403|Secondary|FEV1 AUC 0-3h Response After the First Dose|Adjusted means of Forced Expiratory Volume in One Second (FEV1) Area Under Curve (AUC) 0-3h response [L] after the first dose, calculated using the trapezoidal rule, divided by the duration (3 hours) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.|Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 1|FAS||Litres||Standard Deviation|Mean
809469|NCT01040403|Secondary|FEV1 AUC 0-3h and FEV1 AUC 0-6h Response|Adjusted means of forced expiratory volume in one second (FEV1) area under the curve (AUC) 0-3 hour and AUC 0-6 hour responses [L] after 4 weeks treatment calculated using the trapezoidal rule, divided by the duration (3 h, 6 h) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.|Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post dose for AUC0-3h and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h 4 h, 5 h, 6 h postdose for AUC0-6h on day 29|FAS||Litres||Standard Deviation|Mean
809470|NCT01040403|Secondary|Trough Forced Vital Capacity (FVC) Response|Adjusted means of trough FVC (forced vital capacity) response [L] after 4 weeks treatment. The trough was defined as the mean of the 1 h pre-dose and 10 min pre-dose measurements on day 29. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.|Baseline and 1 hour pre-dose and 10 minutes pre-dose on day 29|FAS which included all patients who were dispensed study medication and who provided baseline and at least 1 on-treatment efficacy value for the primary endpoint after 4 weeks on treatment.||Litres||Standard Error|Mean
809471|NCT01040403|Primary|Trough FEV1 Response|Adjusted means of the trough forced expiratory volume in one second (FEV1) response (L) after four weeks treatment. The trough was defined as the mean of the 1 h pre-dose and 10 min pre-dose measurements on day 29. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.|Baseline and 1 hour pre-dose and 10 minutes pre-dose on day 29|Full Analysis Set (FAS) which comprised all patients in the treated set who provided baseline (study baseline) data and at least 1 on-treatment efficacy value for the primary endpoint after 4 weeks on treatment.||Litres||Standard Deviation|Mean
809472|NCT01040624|Secondary|Collect and Analyze Treatment, Biologic and Diagnostic Information That May Impact Quality of Life, Disease Control, Morbidity and/or Survival Outcomes.||After radiation: every 6 months for 3 years, then annually for 20 years||||||
809473|NCT01040624|Secondary|Collect and Analyze Quality of Life, Treatment-related Late Morbidity, Disease Control, and Survival Outcome Parameters.||After radiation: every 6 months for 3 years, then annually for 20 years||||||
809474|NCT01040624|Primary|Acute Grade 3 or Higher Treatment-related Toxicity Rate.|Number of participants that experienced acute grade 3 or higher, treatment-related toxicity based on CTCAE version 3.0 criteria.|6 months after the completion of radiation therapy|||participants|||Number
809475|NCT01041859|Secondary|Change From Baseline in the EuroQoL-5 Dimension (EQ-5D) Health Status Index at the Week 12 Endpoint|EQ-5D has 5 items (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) rated on a categorical scale of 1-3 with 1=no problems, 2=some problems, 3=extreme problems. The health state index is a weighted combination of the 5 items. It has a range of 0 to 1, with 0=deceased and 1=full health.|Double-blind Baseline and End of Double-Blind Treatment at 12 Weeks|Intent-to-treat (ITT) population. Last observation carried forward (LOCF) endpoint.||units on a scale||Standard Deviation|Mean
809476|NCT01041859|Secondary|Change From Baseline of Open-Label in the Pain Intensity Subscale of the Brief Pain Inventory (BPI) at the Week 12 Double-Blind Endpoint|The BPI is a 12-item questionnaire to evaluate the intensity of pain and the degree to which pain interferes with function. It includes 4 items assessing current pain intensity and pain at its worst, least, and on average over the past day using an 11-point scale from 0 = no pain to 10 = pain as bad as you can imagine. The pain intensity subscale score is defined as the mean of the scores from these 4 items.|Open-label Baseline and End of Double-Blind Treatment at 15 Weeks (3 weeks open-label plus 12 weeks double-blind)|Intent-to-treat (ITT) population. Last observation carried forward (LOCF) endpoint.||units on a scale||Standard Deviation|Mean
809477|NCT01041859|Secondary|Distribution of Patient Global Impression of Change at Week 12 Endpoint|Patient Global Impression of Change (PGIC) is a patient-rated assessment of overall neuropathic pain since the start of treatment using a categorical scale 1-7, where 1 is ‘very much improved’ and 7 is ‘very much worse’|End of Double-Blind Treatment at 12 Weeks|Intent-to-treat (ITT) population. Last observation carried forward (LOCF) end point||percentage of participants|||Number
809478|NCT01041859|Secondary|Responder Analysis: Proportion of Patients With At Least 50% Improvement From Baseline of Open-Label on the Numerical Rating Scale (NRS) at the Week 12 Endpoint|"The NRS was a twice-daily pain assessment in which patients were to indicate the level of pain experienced over the previous 12 hours on an 11-point scale with a score of 0 indicating no pain and a score of 10 indicating pain as bad as you can imagine."|Open-label Baseline and End of Double-Blind Treatment at 15 Weeks (3 weeks open-label plus 12 weeks double-blind)|Intent-to-treat (ITT) population. Last observation carried forward (LOCF) was used to impute pain score after discontinuation.||percentage of participants|||Number
809479|NCT01041859|Primary|Change From Double-Blind Baseline of the Average Pain Intensity Based on an 11-point Numerical Rating Scale(NRS) Over the Last Week of the Maintenance Period at Week 12|"For this twice daily pain assessment, the patients were to indicate the level of pain experienced over the previous 12 hours on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Double-Blind Baseline and 12 weeks (Primary endpoint is the average pain intensity score during the last week of the maintenance period)|Intent-to-treat (ITT) population. Last observation carried forward (LOCF) was used to impute pain score after discontinuation||units on a scale||Standard Deviation|Mean
809480|NCT01041976|Secondary|Employment|"Yes/No: Did veteran work at least one day in a competitive job at any time from randomization to 18 month follow-up.
Outcome: Number of participants who worked at least one day in a competitive job at any time from randomization to 18 month follow-up."|18 months|||participants|||Number
809641|NCT01036763|Secondary|Physician's Global Evaluation at Visit 2|Physician’s global evaluation (PGE) of the patients' general condition at Visit 2 evaluated on an 8-point scale after approximately 6–12 weeks of treatment with Spiriva.|after 6 - 12 weeks|||Participants|||Number
809482|NCT01042093|Secondary|Knee Society Pain Scores at 6 Week Follow-up Appointment|Patients were assessed for pain at their 6 week follow-up appointment using the Knee Society Rating Scale. Using this scale patients are given a pain score ranging from 0 (severe pain) to 50 (No Pain). This is determined as follows: No pain/50 points, Mild or occasional pain/45 points, pain with stairs only/40 points, pain with walking and stairs/30 points, Moderate/occasional pain/ 20 points,continual pain/10 points, severe pain/0 points. We report the mean score for each group. A higher score represents a better outcome.|6 weeks after surgery|||Scores on a scale 0-50||Full Range|Mean
809483|NCT01042093|Secondary|Narcotic Consumption During Hospitalization|A variety of pain medications were used after surgery to keep patients comfortable. Narcotic use was recorded as morphine equivalents. We report the mean narcotic consumption for each group for the day of surgery as well as post operative day 1,2, and 3.|4 days|||mg||Standard Deviation|Mean
809484|NCT01042093|Primary|Numerical Rating Scale (NRS) Pain Scores During Hospitalization.|Patient pain was assessed during hospitalization using the VAS Pain Scale, a numerical rating scale ranging from 0 (no pain) to 10 (severe pain). A lower score represents a better outcome. Pain was assessed preoperatively, 1 hour postoperatively in the post anesthesia unit, and then every 8 hours on the Orthopedic inpatient unit, for a duration of 2 days.|2 days after surgery|||scores on a scale 0-10||Standard Deviation|Mean
809485|NCT01042145|Secondary|Number of Participants With Reported Side Effects||12 days|||percentage of participants|||Number
809486|NCT01042145|Secondary|Time Missed From Work||12 days|||Hours||Standard Deviation|Mean
809487|NCT01042145|Secondary|Parental Stress|Parental stress due to the child's illness was rated using a 4-point categorical scale (ranging from 3-very stressed to 0-not stressed). We report days until the stress rating was 0.|12 days|||days||Standard Deviation|Mean
809488|NCT01042145|Secondary|Nights With Disturbed Sleep||12 days|||nights||Standard Deviation|Mean
809489|NCT01042145|Secondary|Duration of Croup Symptoms||12 days|||days||Standard Deviation|Mean
809490|NCT01042145|Primary|Additional Health Care|The primary outcome was the % of participants who had additional health care for croup within 11 days of randomization assessed by self-report. This dichotomous variable was positive if any of the following occurred: office visit, ED visit or hospitalization for croup care.|11 days|||percentage of participants||95% Confidence Interval|Number
809491|NCT01042158|Secondary|6-minute Walk Distance|patients were made to take a walk of normal speed to cover a distance in 6 minutes and distance covered was recorded. This was done at baseline (week o) and then repeated t 36 weeks.|baseline and 36 weeks|||meters||Standard Deviation|Mean
809492|NCT01042158|Secondary|Tricuspid Annular Plane Systolic Excursion (TAPSE)|The extent of displacement of the tricuspid valves, termed as Tricuspid Annular Plane Systolic Excursion (TAPSE) was measured using a trans-thoracic echocardiogram following Right heart catheterization.|baseline and 36 weeks|||cm||Standard Deviation|Mean
809493|NCT01042158|Primary|Pulmonary Vascular Resistance (PVR)|Change in Pulmonary Vascular Resistance (PVR) was ascertained via Right Heart Catheterization (RHC) measurement of the difference between the PVR at baseline and 36 weeks|baseline 36 weeks|||Wood units||Inter-Quartile Range|Median
809494|NCT01042158|Primary|Right Ventricular (RV) Mass|Assessment of change in Right ventricular mass was done via standard volumetric cine images of the right heart at baseline and comparing it to that at the end of 36 weeks using Cardiac Magnetic Resonance Imaging studies.|baseline and 36 weeks|||grams||Inter-Quartile Range|Median
809495|NCT01042236|Secondary|Plasma 5-hydroxymethyl Tolterodine (5- HMT) Concentration|Plasma 5-HMT concentration data pre and post reflectometry following multiple doses of fesoterodine 4 mg OD and fesoterodine 8 mg OD. Day 7 mean for each treatment period was calculated as the mean of the three measurements taken post-dose on Day 7 of each treatment period separately. Summary statistics were to be calculated by setting concentration values below the lower limit of quantification (LLQ = 0.02 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) = 0.|Baseline, Day 7 of each period|Full Analysis Set (FAS): all randomized subjects who had taken at least one dose of study treatment; (n)=number of participants with observations (non-missing concentrations)||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
809496|NCT01042236|Secondary|Percent Change From Baseline in Urgency Urinary Incontinence Episode Frequency Per 24 Hours|Urgency Urinary Incontinence Component of the daily IEF calculated as the average daily number of urgency leakage episodes that occurred during the 3 days prior to randomization and the end of each treatment period. Day 7 mean for each treatment period was calculated as the mean daily episode frequency based on the diary completed in the final three days of each treatment period.|Baseline, Day 7 of each period|PPAS; (n)=only subjects with >0 participants at baseline were to be included in the analysis.||Percent||Full Range|Median
809497|NCT01042236|Secondary|Urgency Urinary Incontinence Episode Frequency Per 24 Hours|Urgency Urinary Incontinence Component of the daily IEF calculated as the average daily number of urgency leakage episodes that occurred during the 3 days prior to randomization and the end of each treatment period. Day 7 mean for each treatment period was calculated as the mean daily episode frequency based on the diary completed in the final three days of each treatment period.|Baseline, Day 7 of each period|PPAS||Episodes per 24 hours.||Standard Deviation|Mean
809498|NCT01042236|Secondary|Percent Change From Baseline in Stress Incontinence Episode Frequency Per 24 Hours|Stress Incontinence Component of the daily IEF calculated as the average daily number of stress leakage episodes that occurred during the 3 days prior to randomization and the end of each treatment period. Day 7 mean for each treatment period was calculated as the mean daily episode frequency based on the diary completed in the final three days of each treatment period.|Baseline, Day 7 of each period|PPAS; (n)=only participants with >0 episodes at baseline were to be included in the analysis.||Percent||Full Range|Median
809499|NCT01042236|Secondary|Stress Incontinence Episode Frequency Per 24 Hours|Stress Incontinence Component of the daily IEF calculated as the average daily number of stress leakage episodes that occurred during the 3 days prior to randomization and the end of each treatment period. Day 7 mean for each treatment period was calculated as the mean daily episode frequency based on the diary completed in the final three days of each treatment period.|Baseline, Day 7 of each period|PPAS||Episodes per 24 hours.||Standard Deviation|Mean
809642|NCT01036763|Secondary|Physician's Global Evaluation at Visit 1|Physician’s global evaluation (PGE) of the patients' general condition at Visit 1 evaluated on an 8-point scale with the scores “Poor (1, 2)”, “Satisfactory (3, 4)”, “Good (5, 6)” and “Excellent (7, 8)” prior to treatment with Spiriva.|0 weeks|||Participants|||Number
809500|NCT01042236|Secondary|Percent Change From Baseline in Incontinence Episode Frequency Per 24 Hours|Incontinence Episode Frequency (IEF) calculated as the average daily total incontinence episodes (stress or urgency) that occurred during the 3 days prior to randomization and the end of each treatment period. Day 7 mean for each treatment period was calculated as the mean daily episode frequency based on the diary completed in the final three days of each treatment period.|Baseline, Day 7 of each period|PPAS; (n)=only participants with >0 episodes at baseline were to be included in the analysis.||Percent||Full Range|Median
809501|NCT01042236|Secondary|Incontinence Episode Frequency Per 24 Hours|Incontinence Episode Frequency (IEF) calculated as the average daily total incontinence episodes (stress or urgency) that occurred during the 3 days prior to randomization and the end of each treatment period. Day 7 mean for each treatment period was calculated as the mean daily episode frequency based on the diary completed in the final three days of each treatment period.|Baseline, Day 7 of each period|PPAS||Episodes per 24 hours.||Standard Deviation|Mean
809502|NCT01042236|Secondary|Change From Baseline in Closing Urethral Elastance at Day 7|Closing urethral elastance measured by urethral reflectometry calculated as the mean of each of the closing urethral pressure measurements obtained in triplicate at each time point for each participant. Day 7 mean for each treatment period was calculated as the mean of the three measurements taken post-dose on Day 7 of each treatment period separately.|Baseline, Day 7 of each period|PPAS||cmH2O/mm^2||Standard Deviation|Mean
809503|NCT01042236|Secondary|Change From Baseline in Opening Urethral Elastance at Day 7|Opening urethral elastance measured by urethral reflectometry calculated as the mean of each of the opening urethral pressure measurements obtained in triplicate at each time point for each participant. Day 7 mean for each treatment period was calculated as the mean of the three measurements taken post-dose on Day 7 of each treatment period separately.|Baseline, Day 7 of each period|PPAS||cmH2O/millimeter(mm)^2||Standard Deviation|Mean
809504|NCT01042236|Secondary|Change From Baseline in Closing Urethral Pressure at Day 7|Closing urethral pressure measured by urethral reflectometry calculated as the mean of each of the closing urethral pressure measurements obtained in triplicate at each time point for each participant. Day 7 mean for each treatment period was calculated as the mean of the three measurements taken post-dose on Day 7 of each treatment period separately.|Baseline, Day 7 of each period|PPAS||cmH20||Standard Deviation|Mean
809505|NCT01042236|Primary|Change From Baseline in Opening Urethral Pressure (OUP) at Day 7|OUP measured by urethral reflectometry calculated as the mean of all of the OUP measurements obtained in triplicate at each time point for each participant. Day 7 mean for each treatment period was calculated as the mean of the three measurements taken post-dose on Day 7 of each treatment period separately.|Baseline, Day 7 of each period|Per Protocol Analysis Set (PPAS): all randomized participants who completed the study, received treatment in all 3 study periods until end of treatment visit in the third study period, and had not violated any of the inclusion / exclusion criteria or deviated from the protocol in a way that could affect the outcome of the study.||centimeter of water (cmH2O)||Standard Deviation|Mean
809506|NCT01042288|Secondary|Frequency of Adverse Events and Severity as a Measure of Toxicity|Assessed using NCI CTCAE v4.0|Every 3 weeks (1 cycle) for 6 cycles, then every 7 weeks thereafter|||participants|||Number
809507|NCT01042288|Secondary|Objective Response Rate||Projected 18 months|All patients evaluated for response||percentage of evaluated participants|||Number
809508|NCT01042288|Secondary|Median Overall Survival (OS)|Defined as the time between Day 1-Cycle 1 to the date of death from any cause.|18 months|All enrolled and treated patients||months||95% Confidence Interval|Median
809509|NCT01042288|Secondary|Median Progression-free Survival (PFS)|Defined as the time between Day 1-Cycle 1 and date of first documented disease progression or death.|Assessments by clinical evaluation, radiographic status, and date of disease progression, estimated 18 months|All enrolled and treated patients||months||95% Confidence Interval|Median
809510|NCT01042288|Primary|Median Time to Progression (TTP)|Defined as the time between Day 1-Cycle 1 and date of first documented disease progression assessed using Response Evaluation Criteria in Solid Tumors (RECISTS) v1.1.|18 months|All enrolled and treated patients||months||95% Confidence Interval|Median
809511|NCT01042366|Primary|ELISpot Response to Melanoma|Peripheral blood CD8+ and CD4+ T cell responses against autologous tumor cells, and HLA-presented melanoma epitopes, using ELISPOT and MHC-peptide tetramer assays.|12 mo|Patients who met inclusion criteria and received at least 3 doses of the vaccine||participants|||Number
809512|NCT01042366|Primary|Delayed Type Hypersensitivity (DTH) Response|Delayed type hypersensitivity (DTH) response to antigen-loaded autologous, dendritic cell vaccine (DC) injected intradermal in vivo|12 mo|Patients who met inclusion criteria and received at least 3 doses of the vaccine||participants|||Number
809513|NCT01042392|Secondary|Number Patients Reported With Adverse Events (AEs), Serious Adverse Events (SAE) and Death (Period II and Period III)|Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.|8 weeks + 1 day|All randomized patients except one patient from Aliskiren arm who was lost to follow up after visit 2.||Participants|||Number
809514|NCT01042392|Secondary|Change in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) From Last Active Dose Taken to After a One-day Missed-dose|The change in blood pressure was measured between visit 4 (end of the period of double-blind active treatment which was at week 8) and visit 5 (48 hours after the last active dose taken) in the group of patients who received aliskiren or placebo and those who received ramipril or placebo. The analysis of covariance included treatment factor and baseline mean sitting SBP and mean sitting DBP as covariables.|From 8 weeks to 48 hours after week 8|Per-protocol missed dose population included all per protocol population patients who had received the study treatment for period 3 according to the protocol (duration of period 3 and treatment intake). Patients with observation at both time points were included in this analysis.||mmHg||Standard Error|Least Squares Mean
809643|NCT01036763|Primary|Assessment of Tolerability According to Patient|Patient-reported assessment within categories (Very good, good, satisfactory, less satisfactory, unsatisfactory, missing)|6 - 12 weeks|||Participants|||Number
809515|NCT01042392|Secondary|Change in Mean Sitting DBP and SBP in Specified Sub-groups From Visit 2 (Baseline) to Visit 4 (at 8 Weeks)|"The sub-groups were: Riser = patients with >= 55 mmHg difference between the mean SPB measured at the morning surge and the mean minimal SBP measured during the night. The Non-risers in whom the difference is <55 mmHg. Patients called dippers in whom there was a decrease in average nocturnal SBP ≥ 10% compared with average daytime SBP, in contrast to patients non-dippers  in whom this difference was <10%."|Baseline to 8 weeks|Intent to treat population included all randomized patients who had received at least one dose of study drug. It also excluded all those patients from centers that reported more than 90% of BP measurements rounded to 0 or 5. Patients with observation at different categories were included in this analysis.||mmHg||Standard Deviation|Mean
809516|NCT01042392|Secondary|Difference Between the Maximal and the Minimal Mean-hour SPB Measured Between 1 and 8 am at Week 8|Ambulatory blood pressure measurement (ABPM) over 24 hours was performed for all patients on the eve of visit 4 (week 8), the device attached to the ambulatory blood pressure non-dominant arm of the patient. The difference between mean-hour maximum SBP mean-hour minimum SBP between 1 am and 8 am was measured.|At week 8|Intent to treat population included all randomized patients who had received at least one dose of study drug. It also excluded all those patients from centers that reported more than 90% of BP measurements rounded to 0 or 5. Patients with ABPM measurements over 24 hours were included in this analysis.||mmHg||Standard Deviation|Mean
809517|NCT01042392|Secondary|Change in msSBP and msDBP From Visit 2 (Baseline) to Visit 3 (at 4 Weeks)|The arm in which the highest sitting systolic blood pressure (SBP) was found at study entry was used for all subsequent readings. At each study visit, after leaving the patient to rest 5 minutes in a sitting position, the blood pressure (BP) was measured three times with an oscillometric device. The measurements were performed at 1-2 minute intervals. The mean BP was calculated from the 3 readings. The analysis of covariance included treatment factor and baseline mean sitting SBP and mean sitting DBP as covariables.|Baseline to 4 weeks|Intent to treat population included all randomized patients who had received at least one dose of study drug. It also excluded all those patients from centers that reported more than 90% of BP measurements rounded to 0 or 5.||mmHg||Standard Error|Least Squares Mean
809518|NCT01042392|Secondary|Number of the Participants With More Than 55 mmHg Difference Between the Mean SBP Measured at the Morning Surge and the Mean Minimal SBP Measured During the Night|Ambulatory blood pressure measurement (ABPM) over 24 hours was performed for all patients on the day before visit 4, the device attached to the ambulatory blood pressure non-dominant arm of the patient. The BP morning surge was defined as the average of the measurements taken during the first 2 hours after waking the patient. The minimal night blood pressure was defined as the average of the two lowest BP measures (the lowest hourly average) recorded during night time.|After 8 weeks|Intent to treat population included all randomized patients who had received at least one dose of study drug. It also excluded all those patients from centers that reported more than 90% of BP measurements rounded to 0 or 5. Patients with ABPM to evaluate the occurrence or absence of a morning peak were included in this analysis.||Participants|||Number
809519|NCT01042392|Secondary|Percentage of Patients With Controlled Blood Pressure|"The arm in which the highest sitting systolic blood pressure (SBP) was found at study entry was used for all subsequent readings. At each study visit, after leaving the patient to rest 5 minutes in a sitting position, the blood pressure (BP) was measured three times with an oscillometric device. The measurements were performed at 1-2 minute intervals. The mean BP was calculated from the 3 readings.
Controlled blood pressure (BP) is defined as mean office systolic BP/ diastolic BP < 140/90 mmHg."|At 4 and 8 weeks|Intent to treat population included all randomized patients who had received at least one dose of study drug. It also excluded all those patients from centers that reported more than 90% of BP measurements rounded to 0 or 5. Patients with observation at each time point were included in this analysis.||Percentage|||Number
809520|NCT01042392|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)|The arm in which the highest sitting systolic blood pressure (SBP) was found at study entry was used for all subsequent readings. At each study visit, after leaving the patient to rest 5 minutes in a sitting position, the blood pressure (BP) was measured three times with an oscillometric device. The measurements were performed at 1-2 minute intervals. The mean BP was calculated from the 3 readings. The analysis of variance included treatment factor and baseline value of mean sitting DBP as covariable.|Baseline to 8 weeks|Intent to treat population included all randomized patients who had received at least one dose of study drug. It also excluded all those patients from centers that reported more than 90% of BP measurements rounded to 0 or 5. Patients with observation at both time points were included in this analysis.||mmHg||Standard Error|Least Squares Mean
809521|NCT01042392|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)|The arm in which the highest sitting systolic blood pressure (SBP) was found at study entry was used for all subsequent readings. At each study visit, after leaving the patient to rest 5 minutes in a sitting position, the blood pressure (BP) was measured three times with an oscillometric device. The measurements were performed at 1-2 minute intervals. The mean BP was calculated from the 3 readings. The analysis of covariance included treatment factor and baseline mean sitting SBP as covariable.|Baseline to 8 weeks|Intent to treat population included all randomized patients who had received at least one dose of study drug. It also excluded all those patients from centers that reported more than 90% of BP measurements rounded to 0 or 5.||mmHg||Standard Error|Least Squares Mean
809522|NCT01042496|Secondary|Glutamine/Glutamate Ratio Measured in the LDLPC at Baseline Using the ProFit Magnetic Resonance Spectroscopy (MRS) Technique|Two different MRS sequences were used to measure the brain chemicals in a single 2 x 2 x 2 cm cube located in the center of anterior cingulate cortex: an intermediate echo-time PRESS sequence and a 2D J-resolved averaged PRESS sequence. (Note: The 2D J-resolved averaged PRESS sequence was used for this outcome measure.) Spectroscopic data were inspected for quality; subjects whose data were contaminated by artifact were excluded from the study. Spectra were then processed using LCModel to quantify brain chemical levels. Regular brain MRI images were segmented, yielding a map of the amount of CSF in the head. The MRS voxel was overlaid onto the CSF map and the fraction of CSF within the voxel measured. This CSF-corrected measurement was then used for statistical analysis.|baseline|Sample sizes varied between both scanning locations LDLPC and MACC and between metabolites due to imaging results/scan viability. Some subject scans yielded more viable information/ less noise during the scan process. Excessive noise resulted in poor metabolite readings which in-turn were not used in the final analysis.||ratio||Standard Deviation|Mean
809523|NCT01042496|Secondary|Mean Glutamate (GLU) Measured in the MACC and LDLPC Using the ProFit MRS Technique at Baseline for Both Groups, After 12 Weeks of Lamotrigine Monotherapy for the Bipolar Group|Two different MRS sequences were used to measure the brain chemicals in a single 2 x 2 x 2 cm cube located in the center of anterior cingulate cortex: an intermediate echo-time PRESS sequence and a 2D J-resolved averaged PRESS sequence. (Note: The 2D J-resolved averaged PRESS sequence was used for this outcome measure.) Spectroscopic data were inspected for quality; subjects whose data were contaminated by artifact were excluded from the study. Spectra were then processed using LCModel to quantify brain chemical levels. Regular brain MRI images were segmented, yielding a map of the amount of CSF in the head. The MRS voxel was overlaid onto the CSF map and the fraction of CSF within the voxel measured. This CSF-corrected measurement was then used for statistical analysis.|baseline, 12 weeks|Sample sizes varied due to imaging results/scan viability. Excessive noise resulted in poor metabolite readings which in-turn were not used in the final analysis. Baseline: control group MACC n=8, LDLPC n=8, Bipolar group MACC n=13, LDLPC n=13. Bipolar group 12 weeks MACC n=8, LDLPC n=17. The control group did not do the procedure at 12 weeks.||Institutional Units (IU)||Standard Deviation|Mean
809524|NCT01042496|Secondary|N-acetylaspartic Acid (NAA) Measured in the MACC and LDLPC Using the Long TE (TE80) PRESS MRS Technique at Baseline for Both Groups, and After 12 Weeks of Lamotrigine Monotherapy for the Bipolar (BP) Group and BP Responders and Non-responders|Two different MRS sequences were used to measure the brain chemicals in a single 2 x 2 x 2 cm cube located in the center of anterior cingulate cortex: an intermediate echo-time PRESS sequence and a 2D J-resolved averaged PRESS sequence. (Note: The intermediate echo-time PRESS sequence was used for this outcome measure.) Spectroscopic data were inspected for quality; subjects whose data were contaminated by artifact were excluded from the study. Spectra were then processed using LCModel to quantify brain chemical levels. Regular brain MRI images were segmented, yielding a map of the amount of CSF in the head. The MRS voxel was overlaid onto the CSF map and the fraction of CSF within the voxel measured. This CSF-corrected measurement was used for statistical analysis.|baseline, 12 weeks|Samples varied due to imaging results/scan viability. Baseline: control group MACC (M) and LDLPC (L) n=8, BP whole M n=28 (3 didn't complete), L n=27, BP Responders M n=13, L n=11, BP nonresponders M and L n=12; BP whole 12 weeks M and L n=16. BP Responders M and L n=10, BP nonresponders M and L n=6. Controls didn't do the procedure at 12 weeks.||Institutional Units (IU)||Standard Deviation|Mean
809525|NCT01042496|Secondary|Glutamate+Glutamine (GLX) Measured in Mid Anterior Cingulate Cortex (MACC) & Left Dorsal Lateral Prefrontal Cortex (LDLPC) Using Long TE PRESS MRS Technique at Baseline for Both Groups; After 12 Weeks of Lamotrigine Monotherapy for the Bipolar Group|Two different MRS sequences were used to measure the brain chemicals in in anterior cingulate and left dorsal lateral prefrontal cortex : an intermediate echo-time PRESS sequence and a 2D J-resolved averaged PRESS sequence. (Note: The intermediate echo-time PRESS sequence was used for this outcome measure.) Spectroscopic data were inspected for quality; subjects whose data were contaminated by artifact were excluded from the study. Spectra were then processed using LCModel to quantify brain chemical levels. Regular brain MRI images were segmented, yielding a map of the amount of cerebrospinal fluid (CSF); the MRS voxel was overlaid onto the CSF map and the fraction of CSF was measured. This CSF corrected measurement was used for statistical analysis.|baseline, after 12 weeks|Sample sizes varied due to imaging results/scan viability. Excessive noise resulted in poor metabolite readings which in-turn were not used in the final analysis. Baseline: control group MACC n=7, LDLPC n=8, Bipolar group MACC n=18, LDLPC n=27. Bipolar group 12 weeks MACC n=12, LDLPC n=16. The control group did not do the procedure at 12 weeks.||Institutional Units (IU)||Standard Deviation|Mean
809526|NCT01042496|Primary|Mean Montgomery-Åsberg Depression Rating Scale (MADRS) Score at Baseline for Both Groups, and After 12 Weeks of Lamotrigine Monotherapy for the Bipolar Group|The MADRS is a 10-item observer rating scale assessing symptoms of depression. The score ranges from 0 (no depression) to 60 (very depressed). A score of less than 12 is considered clinical remission of depression.|baseline, 12 weeks|The control group only did the MADRS depression rating scale at baseline. 25 participants in the Bipolar group took the MADRS depression rating scale at 12 weeks.||units on a scale||Standard Deviation|Mean
809527|NCT01042509|Secondary|Side Effects|Percentage of participants who experienced side effects|365 days|15 consecutive patients were included for the analysis with periodical clinical evaluations to assess adverse effects.||Participants|||Count of Participants
809528|NCT01042509|Primary|Clinical Response of Patients With Refractory Chronic GVHD Based on the Working Group Report 2006.|Overall response of participants to alemtuzumab and rituximab combination at day +30, +90 and +365 of follow-up|30, 90 and 365 days|All consecutive patients were included in an intention to treat analysis to evaluate clinical response to alemtuzumab and rituximab combination.||percentage of participants|||Number
809554|NCT01042938|Secondary|Pain at Radiation Treatment Site|The McGill Pain Questionnaire-Short Form (MPQ-SF) was used to determine the participants pain at treatment site. The MPQ-SF contains three subscales: affective pain, sensory pain, and perceived pain. This outcome measure compared the total pain score (range 0 to 50)and subscale scores (sensory subscale range 0 to 33; affective subscale range 0 to 12; perceived pain subscale 0 to 5) at the end of radiation therapy between the two treatment arms.|4-7 weeks (prescribed course of radiation)|All 30 participants that fully completed the trial were used in these analyses.||units on a scale||Standard Deviation|Mean
809535|NCT01042600|Secondary|Mortality Rate||2 months|||participants|||Number
809536|NCT01042600|Secondary|Number of Intubation Episodes Per Patient||7 days||||||
809537|NCT01042600|Secondary|Complications During Insertion of LMA||96 hrs||||||
809538|NCT01042600|Secondary|Rate of BPD (O2 Dependence at the Later of 28 Days of Age or 36 Weeks Postmenstrual Age)||2 months||||||
809539|NCT01042600|Secondary|Rate of Pneumothorax||96 hrs||||||
809540|NCT01042600|Secondary|Days on Supplemental Oxygen||2 months||||||
809541|NCT01042600|Secondary|Days on Assisted Ventilation||2 months||||||
809542|NCT01042600|Secondary|Number of Surfactant Doses||96 hr||||||
809543|NCT01042600|Primary|Rate of Failure of Surfactant Therapy, Either Early (Need for Mechanical Ventilation Within 1 Hour), or Late (FiO2 > 0.60 to Maintain Target SpO2, or Second Dose of Surfactant Within 8 Hours, or Needing More Than 2 Doses of Surfactant).||96 hours|||participants|||Number
809544|NCT01042613|Secondary|Number of Skin Punctures|To assess if the number of skin punctures is fewer when intravenous access is assisted by the AccuVein AV300 device as compared to the standard technique|At cannulation|||Skin punctures||Standard Deviation|Mean
809545|NCT01042613|Secondary|Time Between Tourniquet Application and Successful Cannulation is Achieved or 4 Attempts Have Been Made (in Minutes).|To assess if insertion of intravenous cannula is faster when intravenous access is assisted by the AccuVein AV 300 device as compared to the standard technique|At cannulation|Of the 146 patients, two patients were excluded due to missing time records.||Minutes||Standard Deviation|Mean
809546|NCT01042613|Primary|First Attempt Success Rate of Cannulation|This study will compare the first attempt success rate of cannulation in research participants randomized to using a new FDA approved AccuVein AV300 device for intravenous access with research participants randomized to standard cannulation methods. There is one timepoint for outcome data collection and it is prior to cannulation. Success (yes) is defined as needle insertion into target vein.|At cannulation|Patients (age 17 years or less) undergoing elective surgery or examination under anesthesia who do not have existing intravenous access.||Participants|||Number
809547|NCT01042678|Secondary|Number of Participants With Positive Binding Anti-MP0112 Antibodies|Blood samples were collected Pre-treatment (Baseline) and Weeks 4, 8 and 12. Samples were analyzed for Anti-MP0112 antibodies using an enzyme-linked immunosorbent assay.|12 weeks|All treated participants.||Participants|||Number
809548|NCT01042678|Secondary|Aqueous Humor Levels of MP0112|Aqueous humor (the thin, watery fluid in the eye) samples were collected from anterior chamber taps and were sent to a laboratory for analysis. Levels of MP0112 were determined using an enzyme-linked immunosorbent assay.|1 Week|All treated participants who consented to participate.||nM||Full Range|Median
809549|NCT01042678|Secondary|Serum Levels of MP0112|Blood samples were collected Pre-treatment (Baseline), Day 1 and 3, Weeks 1, 4, 12, 16. Serum samples (liquid portion of the blood after cells and clotting factors were removed) were sent to a laboratory for analysis. Levels of MP0112 were determined using an enzyme-linked immunosorbent assay.|16 Weeks|All treated participants.||Nanomolar (nM)||Full Range|Median
809550|NCT01042678|Secondary|Change From Baseline in Foveal Thickness as Measured by Optical Coherence Tomography (OCT)|Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the fovea (part of the retina), was performed in the study eye after pupil dilation at Baseline and Week 16. A negative change from Baseline indicated improvement (less foveal thickness).|Baseline, Week 16|All treated participants.||microns||Standard Deviation|Mean
809551|NCT01042678|Secondary|Best-Corrected Visual Acuity (BCVA)|BCVA was measured using an eye chart and was reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye at Baseline and Week 16. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the letters read correctly on the eye chart the better the vision.|Baseline, Week 16|All treated participants with data for a given time point were included for analysis.||Letters||Standard Deviation|Mean
809552|NCT01042678|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Safety and tolerability was assessed by vital signs, clinical laboratory evaluations, ophthalmological examinations, intraocular pressure, the presence of anti-drug antibodies and the collection of adverse events. An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events.|16 weeks|All treated participants.||Participants|||Number
809553|NCT01042795|Primary|Disease Free Survival|2-year disease free survival|2- year|||months|||Number
809555|NCT01042938|Secondary|Redness at Radiation Treatment Site|Redness at radiation treatment site was measured using a CR-400 Colorimeter (Konica Minolta). The colorimeter uses the L*a*b* color scale. We used a* values (redness) which range from 0.0 to 20.0. The lower the number value, the lower amount of redness. Therefore, high number values represent large amounts of redness.|4-7 weeks (prescribed course of radiation)|The 30 participants that fullt completed the trial were used in these analyses.||units on a scale (0.0 to 20.0)||Standard Deviation|Mean
809556|NCT01042938|Secondary|Moist Desquamation at Radiation Treatment Site|The presence of moist desquamation at the end of radiation treatment was examined between curcumin and placebo treatment groups. We compared the number of participants (or percentage) with moist desquamation between each treatment group.|4-7 weeks (prescribed course of radiation)|All 30 participants who completed the trial were used in all analyses.||participants|||Number
809557|NCT01042938|Primary|Severity of Dermatitis in Radiation Treatment Site in Breast Cancer Patients|The severity of radiation dermatitis was measured using the Radiation Dermatitis Severity (RDS)Scale which ranges from 0.0 to 4.0 with increments of 0.5. The RDS scale is a revised form of the NIH Common Toxicity Criteria to account for color and subtle texture changes in the skin. The worst dermatitis (i.e., highest RDS score) at the end of treatment was used for the primary analysis of severity of radiation dermatitis in each treatment group. Additionally, we performed repeated measure analyses to examine the severity of dermatitis over time in each arm.|4-7 weeks (prescribed course of radiation)|We used all 30 participants that fully completed the trial in all of our analyses.||units on a scale||Standard Deviation|Mean
809558|NCT01042977|Secondary|Adjusted Mean Change in Seated Systolic Blood Pressure (SBP) at Week 8 (LOCF) in Participants With Baseline SBP>=130 mmHg|To compare the mean change in seated systolic blood pressure (SBP) in participants with baseline seated SBP ≥130 mmHg achieved with dapagliflozin versus placebo from baseline to week 8.|Baseline to Week 8|Full Analysis set, participants with baseline seated SBP ≥130 mmHg and Week 8 (LOCF) value||mmHg||95% Confidence Interval|Least Squares Mean
809559|NCT01042977|Secondary|Adjusted Mean Change in Seated Systolic Blood Pressure at Week 24 (LOCF)|To compare the mean change in seated systolic blood pressure from baseline to week 24 between dapagliflozin 10 mg versus placebo.|Baseline to Week 24|Full Analysis set, subjects with non-missing baseline and Week 24 (LOCF) values||mmHg||95% Confidence Interval|Least Squares Mean
809560|NCT01042977|Secondary|Adjusted Mean Change in Systolic Blood Pressure at Week 8 (LOCF)|To compare the mean change in seated systolic blood pressure from baseline to week 8 between dapagliflozin 10 mg versus placebo.|Baseline to Week 8|Full Analysis Set, subjects with non-missing baseline and Week 8 (LOCF) values||mmHg||95% Confidence Interval|Least Squares Mean
809561|NCT01042977|Secondary|Proportion of Participants With a Reduction From Baseline of 5% or More in Body Weight in Participants With Baseline BMI ≥27 kg/m²|To compare the proportion of participants with BMI baseline ≥27 kg/m2 with a reduction from baseline of 5% or more in body weight with dapagliflozin 10 mg versus placebo from baseline to week 24. Least Squares Mean represents the percent of participants adjusted for baseline body weight and age stratum.|Baseline to Week 24|Full Analysis Set, subjects with baseline BMI ≥27 kg/m2 and Week 24 (LOCF) values||Percentage of participants||95% Confidence Interval|Least Squares Mean
809562|NCT01042977|Secondary|Adjusted Mean Percent Change in Body Weight|To compare the mean percent change in body weight from baseline to week 24 between dapagliflozin 10 mg versus placebo.|Baseline to Week 24|Full Analysis Set, subjects with non-missing baseline and Week 24 (LOCF) values||Percentage of Body Weight||95% Confidence Interval|Least Squares Mean
809563|NCT01042977|Primary|Proportion of Responders Meeting All Criteria of a 3-item Endpoint of Clinical Benefit|To compare the clinical benefit of dapagliflozin 10 mg versus placebo when added to usual care in type 2 diabetes patients with cardiovascular disease at week 24, measured as the proportion of responders for a 3-item endpoint of clinical benefit, defined as an absolute drop of 0.5% or more from baseline HbA1c, and a relative drop of 3% or more from baseline for total body weight, and an absolute drop of 3 mmHg or more from baseline in seated systolic blood pressure.|Baseline to Week 24|Full Analysis Set, subjects with non-missing baseline and Week 24 (LOCF) values||Percentage of participants||95% Confidence Interval|Number
809564|NCT01042977|Primary|Adjusted Mean Change in HbA1c Levels|To compare the glycemic efficacy of dapagliflozin 10 mg versus placebo when added to usual care in type 2 diabetes patients with cardiovascular disease, measured as the mean change in HbA1c from baseline to week 24.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values||Percent||95% Confidence Interval|Least Squares Mean
809565|NCT01043094|Secondary|Number of Participants With Treatment Emergent Adverse Events||3 Days|||Participants|||Number
809566|NCT01043094|Primary|Area Under the Curve From 0 to Tau (AUC 0-t (ng*h/mL))|Area under the curve from start to elimination for Pitavastatin.|48 hours|||nanogram hour per milliliter (ng•h/mL)||Standard Deviation|Mean
809567|NCT01043133|Secondary|Clinical Note Completeness Score|The Note Completeness Score is a total score (range 1-31)earned when a clinical encounter note is compared against a note completeness score assessment tool designed by our research team. The tool measures 11 documentation components of the outpatient note. Each of the 11 components are scaled either 0-1 or 0-4 based on perceived importance by our physician designers.|immediately after intervention and 30+ days in follow-up|||score||Standard Deviation|Mean
809568|NCT01043133|Primary|Number of Participants Using Evidence-based Template to Document Asthma Care Within an Electronic Medical Record|The primary outcome measure is a count of whether or not the research participant uses the electronic health record-based Asthma AIM form to document a simulated outpatient mild persistent asthma encounter at T1 (immediately following intervention) and T2 (upon completion of family medicine clerkship approximately 35 days later).|immediately after invervention and 30+ days in follow-up|||participants|||Number
809569|NCT01043146|Primary|The Number of Participants Reporting Adverse Events (AEs)|To assess the safety and tolerability of COR-1.|45 days|||Participants|||Number
809570|NCT01043185|Secondary|Number of Weakly Alkaline Reflux Episodes|Number of reflux episodes as defined for the primary outcome measure with an intraesophageal pH ≥6.5 lasting more than 5 s.|Measured during 24 hours at 4 different visits with a 7-28 days interval between|Efficacy Analysis Set (EAS). From the safety analysis set with 27 patients, the EAS excludes 2 patients; 1 due to a positive drug of abuse screen and 1 due to poor quality of the impedance/pH tracings during all 4 study periods. Additionally, 3 patients were partly excluded from the EAS due to poor quality of the tracings during 1 study period.||Episodes||Full Range|Median
809571|NCT01043185|Secondary|Number of Weakly Acidic Reflux Episodes|Number of reflux episodes as defined for the primary outcome measure with an intraesophageal pH 4.0–6.5 lasting more than 5 s.|Measured during 24 hours at 4 different visits with a 7-28 days interval between|Efficacy Analysis Set (EAS). From the safety analysis set with 27 patients, the EAS excludes 2 patients; 1 due to a positive drug of abuse screen and 1 due to poor quality of the impedance/pH tracings during all 4 study periods. Additionally, 3 patients were partly excluded from the EAS due to poor quality of the tracings during 1 study period.||Episodes||95% Confidence Interval|Geometric Mean
809572|NCT01043185|Secondary|Number of Acid Reflux Episodes|Number of reflux episodes as defined for the primary outcome measure with an intraesophageal pH <4 (or a drop of at least 1 pH unit if pH is already <4) lasting more than 5 s.|Measured during 24 hours at 4 different visits with a 7-28 days interval between|Efficacy Analysis Set (EAS). From the safety analysis set with 27 patients, the EAS excludes 2 patients; 1 due to a positive drug of abuse screen and 1 due to poor quality of the impedance/pH tracings during all 4 study periods. Additionally, 3 patients were partly excluded from the EAS due to poor quality of the tracings during 1 study period.||Episodes||95% Confidence Interval|Geometric Mean
809573|NCT01043185|Primary|Total Number of Reflux Episodes During 24 Hours|Number of reflux episodes assessed during ambulatory impedance-pH recording (defined as starting with a drop in impedance to below 50% of baseline and ending when impedance recovers to above 50% of baseline)|Measured during 24 hours at 4 different visits with a 7-28 days interval between|Efficacy Analysis Set (EAS). From the safety analysis set with 27 patients, the EAS excludes 2 patients; 1 due to a positive drug of abuse screen and 1 due to poor quality of the impedance/pH tracings during all 4 study periods. Additionally, 3 patients were partly excluded from the EAS due to poor quality of the tracings during 1 study period.||Episodes||95% Confidence Interval|Geometric Mean
809574|NCT01043393|Secondary|Change From Baseline in Physician's Global Assessment (PGA) Score for Psoriasis|The PGA scale is designed to evaluate the physician’s global assessment of the participant’s psoriasis based on severity of induration,erythema and scaling. The PGA is assessed on a scale of 0 to 5 (0 = clear, 5 = severe).|28 days|No statistical analysis provided for Percentage of Participants With a Physician’s Global Assessment (PGA) of Psoriasis Score of 0 (Clear) or 1 (Almost Clear)||percentage of physician’s global assessm||Standard Deviation|Mean
809575|NCT01043393|Secondary|Change From Baseline in Percent Body Surface Area (%BSA) Affected by Psoriasis|"Body Surface Area (BSA) is a numerical score used to measure the physician’s assessment of the percentage of the participant’s total BSA involved with psoriasis.
BSA = SQRT ((height (cm) X weight (kg))/3600)
BSA is in m2, W is weight in kg, and H is height in cm. Total body Surface Area (BSA) in meters squared
%Body Surface Area Affected the Rule of Nine was be used"|28 days|"No statistical analysis provided for Percentage of Body Surface Area Affected by Psoriasis.
As the study is not powered sufficiently to perform efficacy statistical analysis, descriptive statistical analysis are presented on the mean change from baseline in % BSA affected"||percentage of Body Surface Area Affected||Standard Deviation|Mean
809576|NCT01043393|Primary|Proportion of Patients in the Study With Hypothalamic Pituitary Adrenal (HPA) Axis Suppression|Each patient is assessed at Day 28. A cortisol response test performed at baseline are reevaluated at the conclusion of the study. If the normal cortisol response test measured at baseline is no long present the patient is considered to have demonstrated possible HPA axis suppression.|28 days|||participants|||Number
809577|NCT01043432|Primary|Iowa Gambling Test|Iowa Gambling Test - Total Raw Score The Iowa Gambling task requires examinees to sit in front of a computer screen displaying four decks of cards (Decks A, B, C, and D) and select a card from any of the four decks. Decks A and B are the disadvantageous decks because they produce high immediate gains however over time examinees will experience a higher loss. Decks C and D are the advantageous decks because they produce lower gains but over time examinees will experience smaller losses. Examinees will make 100 choices (trials). To measure performance, the 100 trials are divided, in order, into 5 'blocks’ of 20. A net score is calculated for each block as the number of cards selected from the advantageous decks minus the disadvantageous decks and the total raw score is the sum of the scores for blocks 1-5. The overall total score can range from -100 (worst outcome) to 100 (best outcome)and the score for each block can range from -20 to 20|One time - for the vast majority of participants the research protocol was initiated directly after informed consent procedures were completed (within hours). Negative values are possible with this measure, see Outcome Description.|||Total Raw on a scale from -100 to 100||Standard Deviation|Mean
809578|NCT01043523|Other Pre-specified|Change in Information About Lesion Characterization Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images||When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI|Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)||Participants|||Number
809579|NCT01043523|Other Pre-specified|Change in Size of the Primary Lesion Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images||When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI|Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)||Participants|||Number
809580|NCT01043523|Other Pre-specified|Increased Contrast of Primary Lesion vs Background Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images||When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI|Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)||Participants|||Number
809581|NCT01043523|Other Pre-specified|Improved Border Delineation of the Primary Lesion Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images||When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI|Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)||Participants|||Number
809582|NCT01043523|Other Pre-specified|Change in Number of Lesions Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images||When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI|Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)||Participants|||Number
831848|NCT01243320|Primary|Change in Albumin Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days|||g/dL||95% Confidence Interval|Mean
809583|NCT01043523|Secondary|Sensitivity, Specificity and Accuracy of Blinded Read of Precontrast and Combined Precontrast/Postcontrast Images Based on Final Diagnosis.|Sensitivity is the probability that a test indicates there is disease when there is disease. Specificity is the probability that a test indicates there is no disease when there is no disease. Accuracy is the probability that a test is correct: the test indicates there is no disease when there is no disease and it indicates there is disease when there is disease.|When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI|Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)||Percentage points|||Number
809584|NCT01043523|Secondary|Final Diagnosis (SoT) by Clinical Investigator||When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI|Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)||Participants|||Number
809585|NCT01043523|Secondary|The Overall Image Quality for the Postcontrast Image Only||When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI|Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)||Participants|||Number
809586|NCT01043523|Secondary|Change in Recommended Next Course of Subject Management / Therapy – Comparison of Precontrast Versus Combined Precontrast/Postcontrast Images (Only Subjects for Whom a Change Was Documented)||When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI|45 subjects had a change from additional imaging with contrast-enhanced MRI based on the precontrast images to definitive therapy.||Participants|||Number
809587|NCT01043523|Secondary|Change in Recommended Next Course of Subject Management/Therapy Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images||When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI|Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)||Participants|||Number
809588|NCT01043523|Secondary|Change in Number of Malignant Lesions Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images|Change in number of malignant lesions was defined as a change from more to less or less to more obtained from the combined precontrast and postcontrast images as compared with the precontrast images|When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI|Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)||Participants|||Number
809589|NCT01043523|Secondary|Change in Number of Nonmalignant Lesions Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images|Change in number of nonmalignant lesions was defined as a change from more to less or less to more obtained from the combined precontrast and postcontrast images as compared with the precontrast images|When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI|Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)||Participants|||Number
809590|NCT01043523|Secondary|Change in Confidence of Diagnosis Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images||When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI|Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)||Participants|||Number
809591|NCT01043523|Secondary|Change in Diagnosis Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images||When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI|Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)||Participants|||Number
809592|NCT01043523|Primary|Vital Signs: Mean Change From Baseline in Diastolic Blood Pressure||14 days prior to and up to 24 hours post-Eovist/Primovist MRI|The vital signs analyses were performed on participants in the Full Analysis Set (FAS) who had vital signs collected both precontrast and postcontrast||mmHg||Standard Deviation|Mean
809593|NCT01043523|Primary|Vital Signs: Mean Change From Baseline in Systolic Blood Pressure||14 days prior to and up to 24 hours post-Eovist/Primovist MRI|The vital signs analyses were performed on participants in the Full Analysis Set (FAS) who had vital signs collected both precontrast and postcontrast||mmHg||Standard Deviation|Mean
809594|NCT01043523|Primary|Vital Signs: Mean Change From Baseline in Heart Rate||14 days prior to and up to 24 hours post-Eovist/Primovist MRI|The vital signs analyses were performed on participants in the Full Analysis Set (FAS) who had vital signs collected both precontrast and postcontrast||beats/min||Standard Deviation|Mean
809595|NCT01043523|Primary|Number of Participants With Laboratory Values Considered to be Clinically Relevant Values or Abnormalities 24 Hours Post-injection|The following parameters were analyzed: Hematology: leukocytes, erythrocytes, hematocrit, platelets, hemoglobin, prothrombin time and differential counts (neutrophils total, neutrophils segmented and lymphocytes) Clinical chemistry: lactate dehydrogenase (LDH), alkaline phosphatase, aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transferase (GGT), sodium, potassium, blood urea nitrogen (BUN), glucose, creatinine, total bilirubin, direct bilirubin, indirect bilirubin, total protein, albumin, eGFR, and α-fetoprotein levels.|Up to 24 hours post-Eovist/Primovist MRI|The laboratory analyses were performed on participants in the Full Analysis Set (FAS) who had laboratory values collected||Participants|||Number
809596|NCT01043523|Primary|Number of Participants With Laboratory Values Considered to be Clinically Relevant Values or Abnormalities at Pre-injection Time Point|Laboratory parameters analyzed: Hematology: leukocytes, erythrocytes, hematocrit, platelets, hemoglobin, prothrombin time and differential counts (neutrophils total, neutrophils segmented and lymphocytes); Chemistry: lactate dehydrogenase (LDH), alkaline phosphatase (AKP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transferase (GGT), sodium, potassium, blood urea nitrogen (BUN), glucose, creatinine, bilirubin:, direct bilirubin, indirect bilirubin, total protein, albumin, estimated glomerular filtration rate (eGFR), and α-fetoprotein levels.|14 days prior to Eovist/Primovist MRI|The laboratory analyses were performed on participants in the Full Analysis Set (FAS) who had laboratory values collected||Participants|||Number
809644|NCT01036763|Primary|Assessment of Efficacy According to Patient|patient-reported assessment within categories (Very good, good, satisfactory, less satisfactory, unsatisfactory, missing)|6 - 12 weeks|||Participants|||Number
809597|NCT01043523|Primary|Percentage of Participants With Overall Change in Additional Diagnostic Information Obtained When Comparing the Combined Precontrast/Postcontrast Images With the Precontrast Images.|Overall Change in additional diagnostic information was defined as a change in at least 1 of the 5 variables below obtained from the combined precontrast and postcontrast images as compared with the precontrast images: 1. Change in number of lesions: greater or fewer 2. Improved border delineation of the primary lesion 3. Increased contrast of primary lesion versus. background 4. Change in size of the primary lesion: larger or smaller 5. Change in information about lesion characterization (lesion type): improved, unchanged, worsened|When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI|Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)||Percentage of participants||95% Confidence Interval|Number
809598|NCT01043640|Secondary|Donor Cell Chimerism Following Transplant|Donor cell chimerism is defined as the percentage of bone marrow and blood cells in the recipient that are of donor origin.|One year|||percentage of donor cells||Standard Deviation|Mean
809599|NCT01043640|Secondary|Donor Cell Chimerism Following Transplant|Donor cell chimerism is defined as the percentage of bone marrow and blood cells in the recipient that are of donor origin.|6 months|||percentage of donor cells||Standard Deviation|Mean
809600|NCT01043640|Secondary|Donor Cell Chimerism Following Transplant|Donor cell chimerism is defined as the percentage of bone marrow and blood cells in the recipient that are of donor origin.|Day 100|||percentage of donor cells||Standard Deviation|Mean
809601|NCT01043640|Secondary|Donor Cell Chimerism Following Transplant|Donor cell chimerism is defined as the percentage of bone marrow and blood cells in the recipient that are of donor origin.|Day 42|||percentage of donor cells||Standard Deviation|Mean
809602|NCT01043640|Secondary|Donor Cell Chimerism Following Transplant|Donor cell chimerism is defined as the percentage of bone marrow and blood cells in the recipient that are of donor origin.|Day 28|||percentage of donor cells||Standard Deviation|Mean
809603|NCT01043640|Secondary|Number of Patients Who Died Peri-Transplant|Peri-transplant is defined as within 100 days of transplant.|By Day 100 Post Transplant|||Participants|||Count of Participants
809604|NCT01043640|Secondary|Number of Patients With Grade 4 Graft-Versus-Host Disease (GVHD)||Day 100 Post Transplant|||Participants|||Count of Participants
809605|NCT01043640|Secondary|Number of Patients With Grade 3 Graft-Versus-Host Disease (GVHD)||Day 100 Post Transplant|||Participants|||Count of Participants
809606|NCT01043640|Secondary|Number of Patients With Grade 2 Graft-Versus-Host Disease (GVHD)||Day 100 Post Transplant|||Participants|||Count of Participants
809607|NCT01043640|Secondary|Number of Patients With Grade 1 Graft-Versus-Host Disease (GVHD)||Day 100 Post Transplant|||Participants|||Count of Participants
809608|NCT01043640|Secondary|Number of Patients With Grade 0 Graft-Versus-Host Disease (GVHD)||Day 100 Post Transplant|||Participants|||Count of Participants
809609|NCT01043640|Primary|Number of Patients With Donor Derived Engraftment|Donor derived engraftment is defined as 80 percent or greater donor cells in the recipient's bone marrow and blood cells.|Day 100 Post Transplant|||Participants|||Count of Participants
809610|NCT01043653|Secondary|Maryland Assessment of Recovery in Serious Mental Illness|The Maryland Assessment of Recovery in Serious Mental Illness is a self-report measure of recovery in people with serious mental illness. A total score was calculated by summing item responses (range=25 to 125), with higher total scores indicating greater self-reported recovery.|~ 1-year|||units on a scale||Standard Deviation|Mean
809611|NCT01043653|Primary|Positive and Negative Symptom Scale (PANSS)|The PANSS is a clinician-rated measure of the presence and severity of symptoms of psychosis. A total score was calculated by averaging the responses on the items (range=1 to 7) scores, with higher scores indicating greater severity of psychiatric symptoms.|~1-year|The PANSS had additional missing data from 3 participants||units on a scale||Standard Deviation|Mean
809612|NCT01043705|Primary|CIED Mechanical Complication|All mechanical Complications related to CIED Implant|12 months|"TYRX implants vs. published comparator are prospective arm patients. Non-TYRX CIED retrospective arm vs. TYRX CIED replacements are nested, case-control cohort."||percentage of Participants||95% Confidence Interval|Number
809613|NCT01043705|Primary|Major CIED Infection|CIED Major Infections|12 months|Evaluable patients that have valid entry criteria||percentage of Participants||95% Confidence Interval|Number
809614|NCT01043874|Secondary|Duration of MMR of Nilotinib in Patients With Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) .|MMR is defined as BCR-ABL ratio (%) on IS ≤ 0.1% (corresponds to ≥ 3 log reduction of BCR-ABL transcripts from standardized baseline value|month 24|Full Analysis Set||% participants w/ durable MMR at 24 mos||95% Confidence Interval|Number
809615|NCT01043874|Secondary|Time to First MMR of Nilotinib in Patients With Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) .|MMR is defined as BCR-ABL ratio (%) on IS ≤ 0.1% (corresponds to ≥ 3 log reduction of BCR-ABL transcripts from standardized baseline value|month 24|Full Analysis Set||months||Standard Deviation|Mean
809616|NCT01043874|Secondary|MMR Rate at 24 Months of Nilotinib Treatment on Study in Patients With Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)|MMR is defined as BCR-ABL ratio (%) on IS ≤ 0.1% (corresponds to ≥ 3 log reduction of BCR-ABL transcripts from standardized baseline value|24 months after treatment|Full Analysis Set||% participants achieving MMR||95% Confidence Interval|Number
809617|NCT01043874|Primary|MMR Rate at 12 Mos. of Nilotinib Treatment on Study in Patients With Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Who Have a Suboptimal Molecular Response to Imatinib at 18 Months or Later.|MMR is defined as BCR-ABL ratio (%) on IS ≤ 0.1% (corresponds to ≥ 3 log reduction of BCR-ABL transcripts from standardized baseline value|12 months after treatment|Full Analysis Set||% participants achieving MMR||95% Confidence Interval|Number
809618|NCT01043926|Secondary|Number of Participants Who Discontinued Study Due to an AE|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug.|From administration of study drug through 14 days after administration of study drug|All Treated Participants||participants|||Number
809645|NCT01036763|Primary|Assessment of Tolerability According to Physician|Physician's assessment of tolerability (positve/ negative), concurrent proportion of positive efficacy assessments by both physician and patient was determined|6 - 12 weeks|||Participants|||Number
809620|NCT01043926|Primary|AUC(0-∞) After Single Dose Suvorexant: Mild Hepatic Insufficiency Participants Versus Healthy Participants (Part II)|Overall exposure was assessed by the area under the plasma concentration versus time curve from time zero to infinity (AUC[0-∞]). AUC(0-∞) was calculated as the sum of the AUC to the last time point with a detectable plasma concentration (AUC[0-last]) and Ct/λ, where Ct was the last measurable concentration and λ was the apparent terminal rate constant.|Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, and 144 hours post-dose|Per protocol, the decision to perform AUC(0-∞) analysis in mild hepatic insufficiency participants was conditional on results of AUC(0-∞) analysis in moderate hepatic insufficiency participants. Since the primary hypothesis in moderate hepatic insufficiency participants was met, AUC(0-∞) analysis in mild hepatic insufficiency was not done.|||||
809621|NCT01043926|Secondary|Maximum Plasma Concentration (Cmax) of Suvorexant After Single Dose: Moderate Hepatic Insufficiency Participants Versus Healthy Participants|Cmax was defined as the maximum observed concentration of a drug after administration.|Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, and 144 hours post-dose|All Treated Participants||μM||95% Confidence Interval|Geometric Mean
809622|NCT01043926|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to Infinity (0-∞) After Single Dose Suvorexant: Moderate Hepatic Insufficiency Participants Versus Healthy Participants (Part I)|Overall exposure was assessed by the area under the plasma concentration versus time curve from time zero to infinity (AUC[0-∞]). AUC(0-∞) was calculated as the sum of the AUC to the last time point with a detectable plasma concentration (AUC[0-last]) and Ct/λ, where Ct was the last measurable concentration and λ was the apparent terminal rate constant.|Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, and 144 hours post-dose|All Treated Participants||μM•hr||95% Confidence Interval|Geometric Mean
809623|NCT01043939|Secondary|Change in High Sensitivity C-Reactive Protein (Hs-CRP)|Change from baseline in high sensitivity C-Reactive Protein (hs-CRP) at 4 weeks, a biomarker of inflammation|4 weeks|||mg/L||95% Confidence Interval|Geometric Mean
809624|NCT01043939|Secondary|Change in Myeloperoxidase (MPO)|Change from baseline in Myeloperoxidase (MPO) at 4 weeks, a biomarker of oxidative stress|4 weeks|||ng/mL||95% Confidence Interval|Geometric Mean
809625|NCT01043939|Secondary|Change in Oxidized LDL|Change from baseline in Oxidized LDL at 4 weeks, a biomarker of oxidative stress|4 weeks|||Units/Liter||Standard Error|Least Squares Mean
809626|NCT01043939|Primary|Change in Endothelial Function (Reactive Hyperemia Peripheral Arterial Tonometry (RH-PAT) Index Score)|"Difference of least square means (95% Confidence Interval) in RH-PAT Index Scores between juice groups. Higher RH-PAT scores indicate better endothelial function; a positive difference of least square means is suggestive of an improvement in endothelial function.
Probes were placed on the index fingers of both hands and a blood pressure cuff was placed on one arm. The cuff was inflated to suprasystolic pressure and the digital pulse volume was recorded before, during & after a 5 minute occlusion period. The ratio of the hyperemic and the baseline pulse amplitude (corrected for the same ratio on the control finger) was calculated and expressed as the RH-PAT index score. Lower scores reflect worse endothelial function."|4 weeks (change since baseline)|Intent-to-Treat analysis||units on a scale||Standard Error|Least Squares Mean
809627|NCT01044030|Secondary|Antimicrobial Resistance Patterns of Isolates of Streptococcus Pneumoniae and Nontypeable Haemophilus Influenzae Cultured From the Oropharynx and/or Nasopharynx of Subjects Treated With Viscous-adherent Xylitol Compared to Placebo.||12 weeks||||||
809628|NCT01044030|Secondary|Effect of Viscous-adherent Xylitol on Nasopharyngeal and Oropharyngeal Colonization With Streptococcus Pneumoniae and Nontypeable Haemophilus Influenzae|Proportion of subjects acquiring colonization with Streptococcus pneumoniae and/or nontypeable Haemophilus influenzae among the subset of patients recruited at the local enrolling sites|12 weeks|This outcome measure is limited to those subjects enrolled in the local enrolling sites only.||percentage of participants|||Number
809629|NCT01044030|Secondary|Effectiveness of Viscous-adherent Xylitol in Reducing Antibiotic Use in Children With Recurrent Acute Otitis Media|Proportion of subjects with no antibiotic use during the study period|12 weeks|||percentage of participants|||Number
809630|NCT01044030|Primary|Effectiveness of Viscous-adherent Xylitol Syrup in Reducing Episodes of Clinically-diagnosed Acute Otitis Media|Proportion of subjects who remained free of acute otitis media throughout the study period|12 weeks|||percentage of particpants|||Number
809631|NCT01044056|Primary|AUC 0-infinity (PK Parameter) for the ASPE Group.|AUC 0-infinity was measured using ethinylestradiol serum concentration using a radio-immune assay at several time points during the 21 days of active treatment and the washout period thereafter. AUC 0-infinity was calculated as AUC 0-tlast extrapolated to infinity using the regression line from which t 1/2 was calculated.|21 days of active treatment and the washout period thereafter|||ng.h/mL||Standard Deviation|Mean
809632|NCT01044056|Primary|AUC 0-tlast (PK Parameter) for the ASPE Group.|AUC 0-tlast was measured using ethinylestradiol serum concentrations using a radio-immune assay at several time points during the 21 days of active treatment and the washout period thereafter.|21 days of active treatment and washout period thereafter|Subjects who received at least one dose of medication.||ng.h/mL||Standard Deviation|Mean
809633|NCT01044056|Primary|Area Under the Curve (AUC) 0-21 Days (PK Parameter) Measured for the ASPE Group|AUC 0-21 days was measured using ethinylestradiol serum concentration using a radio-immune assay at several time points during the 21 days of active treatment|21 days|Subjects who received at least one dose of medication.||nh.h/mL||Standard Deviation|Mean
809634|NCT01044056|Primary|Maximum Concentration (Cmax) (Pharmacokinentic Parameter (PK)) for All Subjects in the Pharmacokinetically Evaluable (ASPE) Group|Cmax was measured using ethinylstradiol serum concentration at several time points during the 21 days of active treatment and the washout thereafter.|21 days of active treatment and washout period thereafter|Subjects who received at least one dose of medication||pg/ml||Standard Deviation|Mean
809635|NCT01044212|Secondary|Consistency of First Postoperative Bowel Movement|"The consistency of the first post-operative bowel movement was rated using the Bristol Stool Scale. This is a validated scale that is widely used. It is given to patients as a chart. The chart can be seen here: http://en.wikipedia.org/wiki/Bristol_stool_scale.
The seven types of stool are:
Type 1: Separate hard lumps, like nuts (hard to pass) Type 2: Sausage-shaped, but lumpy Type 3: Like a sausage but with cracks on its surface Type 4: Like a sausage or snake, smooth and soft Type 5: Soft blobs with clear cut edges (passed easily) Type 6: Fluffy pieces with ragged edges, a mushy stool Type 7: Watery, no solid pieces. Entirely liquid"|Within 1 week of surgery|||Bristol Stool Scale||Standard Deviation|Mean
809647|NCT01036763|Primary|Success of Treatment With Tiotropium According to Physician's Assessment|Evaluation of important outcome parameters (pulmonary function, dyspnoe, health-related quality of life, exercise capacity, prevention of exacerbations) which were used for the physician´s decision to assess the treatment as successful|6 - 12 weeks|All patients who were documented to have taken at least one dose of Spiriva®18 Microgram/Spiriva® Respimat® and had COPD requiring long-acting anticholinergics||Participants|||Number
809648|NCT01036802|Secondary|Major and Minor Bleeding Complications|We evaluated the safety of warfarin by evaluating for major and minor bleeding complications in study subjects|Evaluations were obtained at Screening, and at Months 3, 6, 9, and 12|||participants|||Number
809649|NCT01036802|Secondary|All-cause Mortality|We assessed the effect of warfarin on mortality in the study subjects|Assessment was obtained until completion of study at 12 months|||participants|||Number
809650|NCT01036802|Secondary|Endothelial Activation|We assessed the effect of warfarin on plasma measures of endothelial activation (soluble vascular cell adhesion molecule-1)|Measurements were obtained at Screening, and at Months 3, 6, 9, and 12|As the number of subjects studied were very few, requiring discontinuation of the study, evaluation of endothelial activation was not performed.|||||
809651|NCT01036802|Secondary|Platelet Activation|We evaluated the effect of anticoagulation with warfarin on platelet activation assessed by measuring plasma levels of soluble CD40 ligand|Measurements were obtained at Screening, Prior to Run-in, and at Months 3, 6, 9, and 12|No analysis was performed due to the early termination of the study and the very small number of participating subjects.|||||
809652|NCT01036802|Secondary|Thrombin Generation|We evaluated the effect of warfarin on a plasma measure of thrombin generation (thrombin-antithrombin complex)|Measurements were obtained at Screening, and at Months 3, 6, 9, and 12|No analysis was performed due to the early termination of the study and the very small number of participating subjects.|||||
809653|NCT01036802|Secondary|6-minute Walk Test|We evaluated the distance walked over 6 minutes. The presented data are average values for the study subjects in the treatment group. When data was missing, the previous value was carried forward.|Measurements were obtained at Screening, Months 3, 6, 9, and 12|||feet||Full Range|Mean
809654|NCT01036802|Primary|Effect of Anticoagulation on Pulmonary Artery Systolic Pressure Was Obtained by Doppler Echocardiography|We determined the effect of anticoagulation with warfarin on estimated pulmonary artery systolic pressure obtained by Doppler echocardiography. The presented data are average values for the study subjects in the treatment group. When data was missing, the previous value was carried forward.|Measurements were obtained at Screening, and at Months 3, 6, 9, and 12|||mm Hg||Full Range|Mean
809655|NCT01037088|Primary|Participants With 30% or Greater Reduction in Pain Intensity|The primary outcome variable, VAS Pain Intensity, was assessed by asking participants to indicate the intensity of their current pain on a 100-mm visual analog scale (VAS) between 0 (no pain) and 100 (worst possible pain).An assessment was performed before the administration of vaporized cannabis or placebo and hourly thereafter for six hours.|baseline to six hours|This was a cross over study. Ten of the 38 subjects who were exposed to placebo had a 30% reduction in pain intensity as compared to 21 of the 37 exposed to the low dose and 22 of the 36 receiving the medium dose of cannabis.||percentage of participants||95% Confidence Interval|Number
809656|NCT01037114|Secondary|Number of Subjects Reporting SAEs Related to Study Participation or a Concurrent GSK Medication.|An SAE is any untoward medical occurrence that: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|Up to Year 20.|The LT Total cohort included all subjects who returned at each annual time point and who belonged to the Total cohort in the primary study.||Subjects|||Number
809657|NCT01037114|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|"One subject received a challenge dose of Havrix at Year 18 and another at Year 20.
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity."|During the 31-day (Days 0-30) follow-up period after the Havrix™ challenge dose.|The analysis was performed on the long-term total cohort which included subjects who returned at the blood sampling time point for whom results were available and who received a challenge dose of Havrix vaccine because their anti-HAV antibody concentrations were < 15 mIU/mL.||subjects|||Number
809658|NCT01037114|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|"Only 1 subject received a challenge dose at Year 16 of Engerix-B.
An SAE is any untoward medical occurrence that: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above."|During the 31-day (Days 0-30) follow-up period after the Engerix™-B challenge dose.|The analysis was performed on the long-term total cohort which included subjects who returned at the blood sampling time point for whom results were available and who received a challenge dose of Engerix-B vaccine because their anti-HBs antibody concentrations were < 10 mIU/mL.||Subjects|||Number
809659|NCT01037114|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|"At Year 16, 1 subject was administered a challenge dose of Engerix™-B and at Y18 and Y20, 2 subjects were administered a challenge dose of Havrix™.
An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product."|31 days (Days 0-30) after the challenge dose of Engerix-B and Havrix.|The analysis was performed on the long-term total cohort which included subjects who returned at the blood sampling time point for whom results were available and who received a challenge dose of Engerix-B vaccine or Havrix.||Subjects|||Number
809676|NCT01037127|Primary|Number of Participants With Best Confirmed Response|Best confirmed response was assessed by the Investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Best response was measured either as a complete response (CR), defined as the disappearance of all target lesions and pathological lymph nodes <10 millimeters (mm), or a partial response (PR), defined as at least a 30% decrease in the sum of the diameters of target lesions. To be assigned a status of confirmed CR or PR, a confirmatory disease assessment was required no less than 28 days after the criteria for response were first met.|From Baseline (Day 1) until the time of the first documented evidence of a confirmed complete response or partial response (up to approximately 25 weeks)|All Treated Population: all participants who received at least one dose of investigational product||Participants|||Number
809660|NCT01037114|Secondary|Number of Subjects With Anamnestic Response to the Challenge Dose of Havrix|"Anti-HAV anamnestic response to the challenge dose was defined as:
Anti-HAV antibody concentrations ≥ 15 mIU/mL at one month post-challenge dose, in subjects seronegative at the pre-challenge time point.
At least a 2-fold increase in anti-HAV antibody concentrations one month after the challenge dose, in subjects having anti-HAV antibody concentrations ≥ 100 mIU/mL at the pre-challenge time point.
Or at least a 4-fold increase in anti-HAV antibody concentrations one month after the challenge dose, in seropositive subjects having anti-HAV antibody concentrations < 100 mIU/mL at the pre-challenge time-point."|30 days after the challenge dose of Havrix|The analysis was performed on the long-term according-to-protocol (LT ATP) cohort for immunogenicity which included subjects who returned at the blood sampling time point for whom results were available and who received a challenge dose of Havrix vaccine because their anti-HAV antibody concentrations were < 15 mIU/mL.||subjects|||Number
809661|NCT01037114|Secondary|Number of Subjects With Anamnestic Response to the Challenge Dose of Engerix-B|"At Year 16 only 1 subject was eligible for the challenge dose of Engerix-B.
Anti-HBs anamnestic response to the challenge dose was defined as:
Anti-HBs antibody concentrations >= 10 mIU/mL at one month post-challenge dose in subjects seronegative at the pre-challenge time point.
At least a 4-fold increase in anti-HBs antibody concentrations, at one month post-challenge dose in subjects seropositive at the pre-challenge time point."|30 days after the challenge dose of Engerix-B|The analysis was performed on the long-term according-to-protocol (LT ATP) cohort for immunogenicity which included subjects who returned at the blood sampling time point for whom results were available and who received a challenge dose of Engerix-B vaccine because their anti-HBs antibody concentrations were < 10 mIU/mL.||Subjects|||Number
809662|NCT01037114|Secondary|Anti-HAV Concentrations After the Challenge Dose of Havrix.|Concentration was given in mIU/mL. Only 2 subjects were eligible for the challenge dose of Havrix, one at Year 18 and another at Year 20 time point. Therefore the values for these subject are given without a measure of dispersion.|Before, 14 days and one month (30 days) after the challenge dose of Havrix|The analysis was performed on the long-term according-to-protocol (LT ATP) cohort for immunogenicity which included subjects who returned at the blood sampling time point for whom results were available and who received a challenge dose of Havrix vaccine because their anti-HAV antibody concentrations were < 15 mIU/mL.||mIU/mL|||Number
809663|NCT01037114|Secondary|Anti-HBs Concentrations After the Challenge Dose of Engerix-B|"Concentration was given in mIU/mL.
Only 1 subject was eligible for the challenge dose of Engerix-B at the Year 16 time point. Therefore the values for this subject are given without a measure of dispersion."|Before, 14 days and one month (30 days) after the challenge dose of Engerix-B|The analysis was performed on the long-term according-to-protocol (LT ATP) cohort for immunogenicity which included subjects who returned at the blood sampling time point for whom results were available and who received a challenge dose of Engerix-B vaccine because their anti-HBs antibody concentrations were < 10 mIU/mL.||mIU/mL|||Number
809664|NCT01037114|Primary|Anti-HAV and Anti-HBs Geometric Mean Concentrations (GMCs)|Concentrations were expressed as GMCs in mIU/mL.|At Years 16, 17, 18, 19 and 20.|The analysis was performed on the long-term according-to-protocol (LT ATP) cohort for immunogenicity which included subjects who returned at a particular blood sampling time point, who were included in the ATP analysis for the primary study and who did not receive hepatitis A or B vaccination that was not specified in the protocol.||mIU/mL||95% Confidence Interval|Geometric Mean
809665|NCT01037114|Primary|Number of Subjects Seropositive for Anti-hepatitis A Virus Antibodies (Anti-HAV) and Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies and With Anti-HBs Antibody Concentrations >= 10 Milliinternational Units Per Milliliter (mIU/mL)|Seropositivity for anti-HAV antibodies is defined as antibody concentrations >= 15 milliinternational units per milliliter (mIU/mL). Seropositivity for anti-HBs antibodies is defined as antibody concentrations >= 6.2 mIU/mL.|At Years 16, 17, 18, 19 and 20.|The analysis was performed on the long-term according-to-protocol (LT ATP) cohort for immunogenicity which included subjects who returned at a particular blood sampling time point, who were included in the ATP analysis for the primary study and who did not receive hepatitis A or B vaccination that was not specified in the protocol.||Subjects|||Number
809666|NCT01037127|Secondary|Number of Participants With Tumor Progression|Tumor progression was assessed as disease progression (DP), defined as at least a 20 percent increase in the sum of diameters of target lesions (representative of all involved organs), taking as reference the smallest sum on study; unequivocal progression of non-target lesions; or the appearance of a new lesion. Because melanoma often progresses to the brain/central nervous system (CNS) and this study enrolled approximately 20% participants with prior brain metastases, tumor progression in the brain/CNS was summarized. Paticipants could have been included in more than one category.|Baseline (Day 1) until tumor progression (up to approximately 57 weeks)|All Treated Population||Participants|||Number
809667|NCT01037127|Secondary|Number of Participants Who Survived Until 6 Months, 12 Months and 24 Months From Baseline|Overall survival (defined as the time from the treatment start date until death due to any cause) data data are presented as the number of participants who were alive 6 months, 12 months and 24 months after Baseline. Participants who had not died were censored at the date of the last adequate tumor assessment at the time of the cut-off.|Month 6, Month 12 and Month 24|All Treated Population||Participants|||Number
809668|NCT01037127|Secondary|Overall Survival|Overall survival is defined as the time from the treatment start date until death due to any cause. Participants who had not died were censored at the date of the last adequate tumor assessment at the time of the cut-off.|Baseline (Day 1) until death due to any cause (up to 134 weeks)|All Treated Population||Months||95% Confidence Interval|Median
809677|NCT01037192|Secondary|Microbiological Efficacy|Microbiological efficacy is defined as favourable if a repeat culture is negative, if no more materail was obtainable for culture, or if a new microorganism is cultured without clinical signs of infection. It is defined as unfavourable when repeat cultures are positive for the same microorganism, when a new microorganism is cultured with clinical signs of infection or when vancomycin resistance develops. It is defined as indeterminate when the patient is treated with another antibiotic to which the microorganism is susceptible or when no microorganism was cultured at the start of therapy.|5 days|||participants|||Number
809678|NCT01037192|Primary|Clinical Efficacy|Clinical efficacy is determined on the fifth and last day of therapy and is defined favourable if there is resolution of symptoms of infection, return to normal body temperature for at least 48 hours, and normalization or a decrease (> 15%) in leukocytes.|5 days|||participants|Participants||Number
809669|NCT01037127|Secondary|PFS in the Indicated Subgroups of Participants Previously Treated With Standard Therapy But Not BRAF Inhibitors|PFS was analyzed for the following subgroups of participants previously treated with standard therapy but not BRAF inhibitors: (1) participants with prior (before the start of this study) brain metastases (mets); (2) participants without prior brain mets; (3) participants with BRAF mutation V600E; (4) participants with BRAF mutation V600E and no prior brain mets; and (5) participants with BRAF mutation V600K. Per RECIST version 1.1, PFS is defined as the interval between the treatment start date and the earliest date of disease progression (at least a 20 percent increase in the sum of diameters of target lesions, taking as reference the smallest sum on study; unequivocal progression of non-target lesions, or the appearance of a new lesion) or death due to any cause, whichever occurred earliest. Brain metastasis is a cancer that has spread to the brain from another location of the body.|Baseline (Day 1) until the time of disease progression or death due to any cause (up to approximately 57 weeks)|All Treated Population. A single participant could have been included in more than one subgroup. Subgroup analysis was not conducted in participants previously treated with BRAF inhibitors because this subgroup was stopped for futility and nearly all the participants progressed before 4 months.||Months||95% Confidence Interval|Median
809670|NCT01037127|Secondary|Progression-free Survival (PFS)|PFS is defined as the interval between the treatment start date and the earliest date of disease progression (at least a 20 percent increase in the sum of diameters of target lesions, taking as reference the smallest sum on study; unequivocal progression of non-target lesions, or the appearance of a new lesion) or death due to any cause, whichever occurred first. Participants who had not progressed or died were censored at the date of the last adequate tumor assessment at the time of the cut-off.|Baseline (Day 1) until the time of disease progression or death due to any cause (up to approximately 57 weeks)|All Treated Population||Months||95% Confidence Interval|Median
809671|NCT01037127|Secondary|Duration of Tumor Response|Duration of tumor response is defined as the time from the first documented evidence of a CR or PR to disease progression (at least a 20 percent increase in the sum of diameters of target lesions, taking as reference the smallest sum on study; unequivocal progression of non-target lesions, or the appearance of a new lesion) or death due to any cause. No participants who were previously treated with BRAF inhibitors had a CR, defined as the disappearance of all target lesions and pathological lymph nodes <10 millimeters, or a PR, defined as at least a 30% decrease in the sum of the diameters of target lesions; thus, no duration of response data can be presented.|From the time of the first documented evidence of a confirmed CR or PR until disease progression or death due to any cause (up to approximately 40 weeks)|All Treated Population. Only those participants who had a confirmed CR or PR were analyzed for duration of response.||Months||95% Confidence Interval|Median
809672|NCT01037127|Secondary|Number of Participants With Any Adverse Event (AE)|An AE is defined as any untoward medical occurrence in a subject or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. AE and serious AE (SAE) data were collected from the start of the investigational product and continued until the End of Treatment Visit. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.|From the date of the first dose of study medication until 28 days after the last dose (up to 477 days)|All Treated Population||Participants|||Number
809673|NCT01037127|Secondary|Mean Plasma Concentrations|Human plasma samples were analyzed for trametinib using a validated analytical method.|Day 15, pre-dose, 0.5-2 hours (hrs) post-dose, 2-4 hrs post-dose, and 4-8 hrs post-dose; Week 4, pre-dose; Week 8, pre-dose; Week 12, pre-dose|Pharmacokinetic (PK) Population: all participants in the All Treated Population for whom PK samples were obtained and analyzed. Only those participants available at the indicated time points were analyzed.||Nanograms (ng)/milliliter (mL)||Standard Deviation|Mean
809674|NCT01037127|Primary|Number of Participants With Best Unconfirmed Response at the Time of the Interim Analysis (Week 8)|An interim analysis was performed using data collected approximately 12 and 13 weeks after the 30th participant was enrolled in the prior BRAF inhibitor and prior standard therapy groups, respectively. The best unconfirmed response by the investigator per RECIST version 1.1 was assessed. The study design permitted stopping the study for futility if <3 best confirmed responses were observed in the first 30 participants of each treatment arm after completing the first post-dose assessment at Week 8. Best response was measured as either a CR, defined as the disappearance of all target lesions and pathological lymph nodes <10 millimeters, or a PR, defined as at least a 30% decrease in the sum of the diameters of target lesions.|Week 8|All Treated Population||Participants|||Number
809675|NCT01037127|Primary|Number of Participants With Best Confirmed Response in the Indicated Subgroups of Participants Previously Treated With Standard Therapy But Not BRAF Inhibitors|The number of participants with best confirmed response was analyzed for the following subgroups of participants previously treated with standard therapy but not BRAF inhibitors: (1) participants with prior (before the start of this study) brain metastases (mets); (2) participants without prior brain mets; (3) participants with BRAF mutation V600E; (4) participants with BRAF mutation V600E and no prior brain mets; and (5) participants with BRAF mutation V600K. Objective response was assessed per RECIST version 1.1. Objective response was measured either as CR, defined as the disappearance of all target lesions and pathological lymph nodes <10 mm, or PR, defined as at least a 30% decrease in the sum of the diameters of target lesions. To be assigned a status of confirmed CR or PR, a confirmatory disease assessment was required no less than 28 days after the criteria for response were first met. Brain metastasis is a cancer that has spread to the brain from another location of the body.|From Baseline (Day 1) until the time of the first documented evidence of a confirmed CR or PR (up to approximately 25 weeks)|All Treated Population. A single participant could have been included in more than one subgroup. Subgroup analysis was not conducted in participants previously treated with BRAF inhibitors because there were no CRs or PRs among these participants.||Participants|||Number
809679|NCT01037218|Secondary|Change in SEP Question 5, Change From Baseline to Overall/Weeks 1-12, mITT|SEP Question 5: Were you satisfied with this overall sexual experience? yes/no response. Percent yes responses at baseline compared with percent yes responses in overall study treatment period.|Baseline and Weeks 1-12|mITT||Percentage Yes Responses||95% Confidence Interval|Least Squares Mean
809680|NCT01037218|Secondary|Change in SEP Question 4, Change From Baseline to Overall Study/Weeks 1-12, mITT|SEP Question 4: Were you satisfied with the hardness of your erection? yes/no response. Percent yes responses at baseline compared with percent yes responses in overall study treatment period.|Baseline and Weeks 1-12|mITT||Percentage Yes Responses||95% Confidence Interval|Least Squares Mean
809681|NCT01037218|Secondary|Change in SEP Question 1, Change From Baseline to Overall/Weeks 1-12, mITT|SEP Question 1: Were you able to achieve at least some erection (some enlargement of the penis)? yes/no response. Percent yes responses at baseline compared with percent yes responses in overall study treatment period.|Baseline and Weeks 1-12|mITT||Percentage Yes Responses||95% Confidence Interval|Least Squares Mean
809682|NCT01037218|Secondary|Change From Baseline to Week 12/Final Visit in Mean Patient Self-Assessment of Erection (PSAE), mITT Population|PASE: Chose one: 1) No evidence of tumescence or erection 2) partial tumescence or erection (not likely to be sufficient for penetration) 3) greater tumescence or erection sufficient for vaginal penetration, but not fully rigid 4) full rigidity; scale 1/poor, no evidence of erection - 4/good, full rigidity|Baseline and Week 12|mITT||Units on a Scale||95% Confidence Interval|Least Squares Mean
809683|NCT01037218|Secondary|Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Derived Score, Subject Version, Week 12/Final Visit, LOCF, mITT|EDITS -sum of responses (mapped to 0/bad-4/good scale, 11 questions standardized to scale of 100): How satisfied are you w/treatment? How likely to continue?, During past 4 wks, has treatment met expectations? How easy to use ? How satisfied w/how quickly it works? How long it lasts? How confident has it made you feel about ability to engage in sex? How satisfied is partner is with treatment effects? How does your partner feel about continuing use? How natural did process of achieving erection feel? Compared to before erection problem, how natural did erection feel in terms of hardness?|Baseline and Week 12|mITT, LOCF||Units on a Scale||95% Confidence Interval|Least Squares Mean
809684|NCT01037218|Secondary|Global Assessment Questionnaire (GAQ), Week 12/Final Visit, mITT Population|While Using the Study Medication, Did You Feel That Your Erections Improved (Yes Responders)|Week 12|mITT||Yes Responders|||Number
809685|NCT01037218|Secondary|Change in Overall Satisfaction Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF|Overall Satisfaction domain: 1/poor - 5/good scoring scale for each of 2 questions (2-10/good). Over last month, how satisfied have you been with your overall sex life? How satisfied have you been with your sexual relationship with your partner?|Baseline and Week 12|mITT, LOCF||Units on a Scale||95% Confidence Interval|Least Squares Mean
809686|NCT01037218|Secondary|Change in Sexual Desire Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF|Sexual Desire domain: 1/poor - 5/good scoring scale for each of 2 questions (2-10/good). Over last month, how often have you felt sexual desire? How would you rate your level of sexual desire?|Baseline and Week 12|mITT, LOCF||Units on a Scale||95% Confidence Interval|Least Squares Mean
809687|NCT01037218|Secondary|Change in Orgasmic Function Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF|Orgasmic Function domain: 0/poor - 5/good scoring scale for each of 2 questions (0-10/good). Over last month, when you had sexual stimulation or intercourse how often did you ejaculate? When you had sexual stimulation or intercourse how often did you have the feeling of orgasm (with or without ejaculation)?|Baseline and Week 12|mITT, LOCF||Units on a Scale||95% Confidence Interval|Least Squares Mean
809688|NCT01037218|Secondary|Change in Satisfaction of Intercourse Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF|Satisfaction of Intercourse domain: 0 (poor) - 5/(good) scoring scale for each of 3 questions (0-15/good). Over last month: How many times have you attempted sexual intercourse? When you attempted intercourse, how often was it satisfactory for you? How much have you enjoyed sexual intercourse?|Baseline and Week 12|mITT, LOCF||Units on a Scale||95% Confidence Interval|Least Squares Mean
809689|NCT01037218|Primary|Changes in Sexual Encounter Profile (SEP), Question 3, Change From Baseline to Overall Study/Weeks 1-12, mITT|Question 3 SEP: Did your erection last long enough for you to have successful completion of intercourse? yes/no response. Percent yes responses at baseline compared with percent yes responses in overall study treatment period.|Baseline and Weeks 1-12|mITT||Percentage of Yes Responses||95% Confidence Interval|Least Squares Mean
809690|NCT01037218|Primary|Changes in Sexual Encounter Profile (SEP), Question 2, Change From Baseline to Overall Study/Weeks 1-12, mITT|Question 2 SEP: Were you able to insert your penis into your partner's vagina? yes/no response. Percent yes responses at baseline compared with percent yes responses in overall study treatment period.|Baseline and Weeks 1-12|mITT||Percentage of Yes Reponses||95% Confidence Interval|Least Squares Mean
809691|NCT01037218|Primary|Change in Erectile Function Domain Assessed by International Index of Erectile Function (IIEF), Baseline to Final Visit/Week 12, mITT (Modified Intent-to-Treat), LOCF (Last Observation Carried Forward)|Erectile Function domain: 0 - 5 scoring scale for each of 6 questions (scale: 0/min/poor - 30/max/good). Over last month: How often were you able to get erection? When you had erections with stimulation, how often were your erections hard enough for penetration? When you attempted intercourse, how often were you able to penetrate your partner? How often were you able to maintain your erection after penetrating your partner? How difficult was it to maintain your erection to completion of intercourse? How do you rate your confidence that you can get & keep your erection?|Baseline and Week 12|mITT, LOCF||Units on a Scale||95% Confidence Interval|Least Squares Mean
809692|NCT01037244|Primary|Change in SEP Question 3, Change From Baseline to Overall Study/Weeks 1-12, mITT|Question 3 SEP: Did your erection last long enough for you to have successful completion of intercourse? yes/no response; no scale. Measured percent yes responses during baseline and compared with percent yes responses during overall treatment period.|Baseline and Weeks 1 - 12|Modified Intent-to-Treat (mITT)||Percentage Yes Responders||95% Confidence Interval|Least Squares Mean
809693|NCT01037244|Secondary|Change in SEP Question 5, Change From Baseline to Overall/Weeks 1-12, mITT|Question 5 SEP: Were you satisfied with this overall sexual experience? yes/no response. Measured percent yes responses during baseline and compared with percent yes responses during overall treatment period.|Baseline and Weeks 1 - 12|Modified Intent-to-Treat (mITT)||Percentage of Yes Responders||95% Confidence Interval|Least Squares Mean
809694|NCT01037244|Secondary|Change in SEP Question 4, Change From Baseline to Overall Study/Weeks 1-12, mITT|Question 4 SEP: Were you satisfied with the hardness of your erection? yes/no response. Measured percent yes responses during baseline and compared with percent yes responses during overall treatment period.|Baseline and Weeks 1 - 12|Modified Intent-to-Treat (mITT)||Percentage of Yes Responders||95% Confidence Interval|Least Squares Mean
809793|NCT01046253|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Cmax.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed. Replicate study design allowed for 2 sets of samples per subject per treatment (N=96 for both test and reference).||ng/mL||Standard Deviation|Mean
809695|NCT01037244|Secondary|Change in SEP Question 1, Change From Baseline to Overall/Weeks 1-12, mITT|Question 1 SEP: Were you able to achieve at least some erection (some enlargement of the penis)? yes/no response. Measured percent yes responses during baseline and compared with percent yes responses during overall treatment period.|Baseline and Weeks 1 - 12|Modified Intent-to-Treat (mITT)||Percentage of Yes Responders||95% Confidence Interval|Least Squares Mean
809696|NCT01037244|Secondary|Change in Overall Satisfaction Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF|Overall Satisfaction domain: 1 (poor) - 5/(good) scoring scale for each of 2 questions (2-10/good). Over last month, how satisfied have you been with your overall sex life? How satisfied have you been with your sexual relationship with your partner?|Baseline and Week 12|Last Observation Carried Forward (LOCF), Modified Intent-to-Treat (mITT)||units on a scale||95% Confidence Interval|Least Squares Mean
809697|NCT01037244|Secondary|Change in Sexual Desire Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF|Sexual Desire domain: 1 (poor) - 5/(good) scoring scale for each of 2 questions (2-10/good). Over last month, how often have you felt sexual desire? How would you rate your level of sexual desire?|Baseline and Week 12|Last Observation Carried Forward (LOCF), Modified Intent-to-Treat (mITT)||units on a scale||95% Confidence Interval|Least Squares Mean
809698|NCT01037244|Secondary|Change in Orgasmic Function Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF|Orgasmic Function domain: 0 (poor) - 5/(good) scoring scale for each of 2 questions (0-10/good). Over last month, when you had sexual stimulation or intercourse how often did you ejaculate? When you had sexual stimulation or intercourse how often did you have the feeling of orgasm (with or without ejaculation)?|Baseline and Week 12|Last Observation Carried Forward (LOCF), Modified Intent-to-Treat (mITT)||units on a scale||95% Confidence Interval|Least Squares Mean
809699|NCT01037244|Secondary|Change in Satisfaction of Intercourse Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF|Satisfaction of Intercourse domain: 0 (poor) - 5/(good) scoring scale for each of 3 questions (0-15/good). Over last month: How many times have you attempted sexual intercourse? When you attempted intercourse, how often was it satisfactory for you? How much have you enjoyed sexual intercourse?|Baseline and Week 12|Last Observation Carried Forward (LOCF), Modified Intent-to-Treat (mITT)||units on a scale||95% Confidence Interval|Least Squares Mean
809700|NCT01037244|Secondary|Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Derived Score, Subject Version, Week 12/ Final Visit, LOCF, mITT Population|EDITS-derived score is sum of responses, range 0/bad-4/good, 11 questions, standardized to scale of 100: How satisfied w/treatment? How likely to continue?, During past 4 wks, has treatment met expectations? How easy to use? How satisfied w/how quickly it works? How long it lasts? How confident made you feel to engage in sex? How satisfied do you believe your partner is with treatment effects? How does your partner feel about your continuing use? How natural did process of achieving erection feel? Compared to before erection problem, how natural did erection feel in terms of hardness?|Baseline to Week 12|mITT Population||units on a scale||95% Confidence Interval|Least Squares Mean
809701|NCT01037244|Secondary|Change From Baseline to Week 12/Final Visit in Mean Patient Self-Assessment of Erection (PSAE), mITT Population|PSAE, select one of the following: 1) no evidence of any tumescence or erection, 2) partial tumescence or erection (not likely to be sufficient for penetration), 3) great tumescence or erection sufficient for vaginal penetration, but not fully rigid, 4) full rigidity, scale 1/no evidence of erection (min) to 4/full erection (max)|Baseline to Week 12|mITT Population||units on a scale||95% Confidence Interval|Least Squares Mean
809702|NCT01037244|Secondary|Global Assessment Questionnaire (GAQ), While Using the Study Medication, Did You Feel That Your Erections Improved? (Yes Responders), Week 12/Final Visit, mITT Population||Week 12|mITT Population||participants|||Number
809703|NCT01037244|Primary|Change in Sexual Encounter Profile (SEP), Question 2, Change From Baseline to Overall Study/Weeks 1-12, mITT|Question 2 SEP: Were you able to insert your penis into your partner's vagina? yes/no response; no scale. Measured percent yes responses during baseline and compared with percent yes responses during overall treatment period.|Baseline and Weeks 1 - 12|Modified Intent-to-Treat (mITT)||Percentage Yes Responders||95% Confidence Interval|Least Squares Mean
809704|NCT01037244|Primary|Change in Erectile Function Domain Assessed by International Index of Erectile Function (IIEF), Baseline to Final Visit/Week 12, mITT (Modified Intent-to-Treat), LOCF (Last Observation Carried Forward)|Erectile Function domain: 0 (poor) - 5/(good) scoring scale for each of 6 questions (0-30/max/good). Over last month: How often were you able to get an erection during sex? When you had erections with stimulation, how often were your erections hard enough for penetration? When you attempted intercourse, how often were you able to penetrate your partner? How often were you able to maintain your erection after penetrating your partner? How difficult was it to maintain your erection to completion of intercourse? How do you rate your confidence that you can get & keep your erection?|Baseline and Week 12|Last Observation Carried Forward (LOCF), Modified Intent-to-Treat (mITT)||units on a scale||95% Confidence Interval|Least Squares Mean
809705|NCT01037309|Primary|Determine the Pharmacokinetics of PRO044||During the 5 weeks of treatment and during the 13 weeks after treatment||||||
809706|NCT01037309|Primary|Safety and Tolerability of PRO044|number of subjects with 1 or more treatment emergent adverse events following SC or IV PRO044|During the 5 weeks of treatment and during the 13 weeks after treatment|||participants|||Number
809707|NCT01037309|Primary|Increase in Dystrophin Expression in the Muscle Biopsies by Immunofluorescence Analyses of Cross-sections and by Western Blot Analyses of Total Protein Extracts||Within 13 weeks after 5 weeks of treatment|For some participants it was not possible to determine dystrophin expression in muscle biopsy||participants|||Number
809708|NCT01037452|Secondary|Measure: Number of Participants That Reported an Adverse Event for the Combination Product, PPI Alone, Antacid Alone and Placebo.||1 day|||participants|||Number
809709|NCT01037452|Secondary|Measure: Maximum Heartburn Intensity for Those Participants Who Experience Any Nighttime Heartburn|"Heartburn severity was measured using a Visual Analog Scale, which was 100 milliimeters long.
0 millimeters: None (no heartburn) 100 millimeters: Most severe"|1 day|||millimeters||95% Confidence Interval|Mean
809710|NCT01037452|Secondary|Measure: Maximum Heartburn Intensity for Those Participants Who Experience Any Heartburn After the Heartburn-inducing Meals|"Heartburn severity was measured using a Visual Analog Scale, which was 100 milliimeters long.
0 millimeters: None (no heartburn) 100 millimeters: Most severe"|1 day|||millimeters||95% Confidence Interval|Mean
809711|NCT01037452|Primary|Measure: Number of Participants With no Heartburn (Post Treatment) Following Consumption of Heartburn-inducing Meal|Participant reported severity of heartburn using a Visual Analog Scale (VAS)directly on CRF every 15 minutes until no heartburn reported or up to 5 hours after 1st heartburn-inducing meal, whichever occurred first. At this point in time, a diary was provided to participants to record any changes in severity of heartburn for 28 hours post treatment.|1 day|||participants||95% Confidence Interval|Number
809712|NCT01044290|Secondary|FACT-G - Social Sub-scale|"Functional assessment of Cancer Therapy-General) is a 27 item survey which assesses physical, social/family, emotional, and functional well being. This sub-scale assesses social well-being. We omitted an item assessing satisfaction with sex life, due to high missing data. Items are rated on a 5 point likert scale, with 0 indicating not at all and 4 indicating, very much in response to item questions. Total sub-scale range is 0 to 30, with higher scores indicating better well-being."|Baseline (n=75, 74, 72), 5 weeks (n=61, 60, 61) and 7 weeks (64, 57, 64)|||units on a scale||Standard Deviation|Mean
809713|NCT01044290|Primary|QUAL-E Life Completion Sub-scale|Quality Of Life At The End Of Life (the QUAL-E 2009) is a 31 item measure of quality of life at the end of life assessing five domains: life completion, relationship with health care providers, preparation for death, physical symptoms and affective social support. We include the 7-item life completion sub-scale as a primary outcomes measure. Individual items used a 5 point likert scale. The sub-scale minimum score was 7 and maximum was 35 with higher scores indicating greater completion.|Baseline (n=75, 74, 72), 5 weeks (n=61, 59, 60) and 7 weeks (n=64, 55, 64)|||units on a scale||Standard Deviation|Mean
809714|NCT01044290|Secondary|FACIT-SP|The Functional Assessment of Chronic Illness Therapy- Spiritual Well-being Scale (Facit-SP) is a 12-item measure of faith, meaning and purpose, with a range of 0 to 48. Higher scores indicate greater spiritual well-being.|Baseline (n=75, 74, 72), 5 weeks (61, 59, 60) and 7 weeks (64, 56, 63)|||units on a scale||Standard Deviation|Mean
809715|NCT01044290|Secondary|CES-D|Center for Epidemiology Studies - Depression Scale (CES-D) is a 10-item measure of depression. Items are rated on a 4 point likert scale with total scores ranging from 0-30. Higher scores indicate greater depressive symptoms.|Baseline (n=75, 74, 72), 5 weeks (n=61, 60, 61) and 7 weeks (n=64, 57, 64)|||units on a scale||Standard Deviation|Mean
809716|NCT01044290|Secondary|POMS Anxiety Sub-scale|The anxiety sub-scale from the modified Brief Profile of Mood States (POMS) is a 5-item measure of psychological distress.Items are on a 5-point likert scale with scoring ranging from 0-20. Higher scores indicate greater anxiety.|Baseline (n=75, 74, 72), 5 weeks (n=61, 60, 60), 7 weeks (n=64, 57, 64)|||units on a scale||Standard Deviation|Mean
809717|NCT01044290|Primary|QUAL-E - Preparation Sub-scale|Quality Of Life At The End Of Life (the QUAL-E 2009) is a 31 item measure of quality of life at the end of life assessing five domains: life completion, relationship with health care providers, preparation for death, physical symptoms and affective social support. We include the 4-item preparation sub-scale as a primary outcomes measure. Individual items used a 5 point likert scale. The sub-scale minimum score was 5 and maximum was 20 with higher numbers indicating higher preparation.|Baseline (n=75, 74, 72), 5 weeks (n=61, 59, 60) and 7 weeks (n=64, 56, 64)|||units on a scale||Standard Deviation|Mean
809718|NCT01044303|Secondary|To Assess the Rate of Rejection, Infection and Renal Function as Mycophenolic Acid Dose is Increased.||24 months|||participants|||Number
809719|NCT01044303|Primary|Percent Change in Mean Fluorescence Index (MFI) of Donor Specific Antibodies (DSA) With Increasing Doses of Enteric-Coated Mycophenolate Sodium (EC-MPS)||24 months|This was a pilot study to examine the effect of MPA escalation on DSA reduction.||percent of MFI change||Standard Deviation|Mean
809720|NCT01044459|Secondary|Change From Baseline in Peak FEV1|Change From Baseline in Peak FEV1 in liters at Week 52.|52 weeks|Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population. Of these 602 patients, 600 (99.2%) had a baseline and at least 1 postbaseline FEV1 assessment and qualified for the ITT Population. A decision to terminate one site was made before unblinding of the study.||L||Standard Error|Least Squares Mean
809721|NCT01044459|Primary|Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1)|Change From Baseline in Morning Predose (Trough) FEV1 in liters at Week 52.|From baseline to 52 weeks|Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population. Of these 602 patients, 600 (99.2%) had a baseline and at least 1 postbaseline FEV1 assessment and qualified for the ITT Population. A decision to terminate one site was made before unblinding of the study.||L||Standard Error|Least Squares Mean
809722|NCT01044498|Secondary|Serum C-reactive Protein (CRP) Level|Blood samples were collected pre-dose of tocilizumab infusion on Day 1 of Cycle 2 and on Days 2, 3, 5, 7, 12, 14, and 21 of Cycle 2, and on Days 1, 7, and 21 of Cycle 3. Serum levels of C-reactive protein were measured by the Tina-quant CRP (latex) high-sensitivity Roche Immunoturbidimetric method.|From Day 1 of Cycle 2 to Day 21 of Cycle 3 for Group 1|Pharmacokinetic (PK) and pharmacodynamic (PD) population: All patients enrolled in the study who had at least 1 evaluable PK or PD sample reading.||mg/L||Standard Deviation|Mean
809723|NCT01044498|Secondary|Serum Soluble Interleukin-6 Receptor (sIL-6R) Level|Blood samples were collected pre-dose and at the end of infusion of tocilizumab on Day 1 of Cycle 2. Additional blood samples were collected on Days 2, 3, 5, 7, 12, 14, and 21 of Cycle 2, and Days 1, 7, and 21 of Cycle 3. Serum levels of soluble interleukin-6 receptor were analyzed using a validated ELISA.|From Day 1 of Cycle 2 to Day 21 of Cycle 3 for Group 1|Pharmacokinetic (PK) and pharmacodynamic (PD) population: All patients enrolled in the study who had at least 1 evaluable PK or PD sample reading.||ng/mL||Standard Deviation|Mean
809724|NCT01044498|Secondary|Apparent Volume of Distribution (Vz) of Tocilizumab|Blood samples were collected pre-dose and at the end of infusion of tocilizumab on Day 1 of Cycle 2. Additional blood samples were collected on Days 2, 3, 5, 7, 12, 14, 21 of Cycle 2, and Days 1, 7, and 21 of Cycle 3. The concentration of tocilizumab was determined in serum samples using a validated ELISA. The apparent volume of distribution (Vz), computed as CL/Kel where CL is clearance and Kel is the apparent elimination rate, was derived from the serum concentrations using a non-compartmental method with the software WinNonlin Enterprise version 5.2 (or above).|From Day 1 of Cycle 2 to Day 21 of Cycle 3 for Group 1|Pharmacokinetic (PK) and pharmacodynamic (PD) population: All patients enrolled in the study who had at least 1 evaluable PK or PD sample reading.||L||Standard Deviation|Mean
824779|NCT01178268|Secondary|Percent Diameter Stenosis||pre procedure|The number of participants with angiographic follow up available was analysed.||percent Diameter stenosis|Participants|Standard Deviation|Mean
809725|NCT01044498|Secondary|Clearance (CL) of Tocilizumab|Blood samples were collected pre-dose and at the end of infusion of tocilizumab on Day 1 of Cycle 2. Additional blood samples were collected on Days 2, 3, 5, 7, 12, 14, 21 of Cycle 2, and Days 1, 7, and 21 of Cycle 3. The concentration of tocilizumab was determined in serum samples using a validated ELISA. Clearance (CL), computed as dose/AUCinf, was derived from the serum concentrations using a non-compartmental method with the software WinNonlin Enterprise version 5.2 (or above).|From Day 1 of Cycle 2 to Day 21 of Cycle 3 for Group 1|Pharmacokinetic (PK) and pharmacodynamic (PD) population: All patients enrolled in the study who had at least 1 evaluable PK or PD sample reading.||mL/hr||Standard Deviation|Mean
809726|NCT01044498|Secondary|Terminal Half-life (t½) of Tocilizumab|Blood samples were collected pre-dose and at the end of infusion of tocilizumab on Day 1 of Cycle 2. Additional blood samples were collected on Days 2, 3, 5, 7, 12, 14, 21 of Cycle 2, and Days 1, 7, and 21 of Cycle 3. The concentration of tocilizumab was determined in serum samples using a validated ELISA. The terminal half-life (t½) was derived from the serum concentrations using a non-compartmental method with the software WinNonlin Enterprise version 5.2 (or above).|From Day 1 of Cycle 2 to Day 21 of Cycle 3 for Group 1|Pharmacokinetic (PK) and pharmacodynamic (PD) population: All patients enrolled in the study who had at least 1 evaluable PK or PD sample reading.||hr||Standard Deviation|Mean
809727|NCT01044498|Secondary|Area Under the Serum Concentration-time Curve From 0 to Infinity (AUCinf) of Tocilizumab|Blood samples were collected pre-dose and at the end of infusion of tocilizumab on Day 1 of Cycle 2. Additional blood samples were collected on Days 2, 3, 5, 7, 12, 14, 21 of Cycle 2, and Days 1, 7, and 21 of Cycle 3. The concentration of tocilizumab was determined in serum samples using a validated ELISA. The area under the serum concentration-time curve from 0 to infinity (AUCinf) was derived from the serum concentrations using a non-compartmental method with the software WinNonlin Enterprise version 5.2 (or above). AUCinf was computed using the linear trapezoidal rule to tlast plus Clast/Kel, where tlast is the time of the last measurable concentration, Clast is the last measurable concentration, and Kel is the apparent elimination rate, computed as the magnitude of the slope from the log-linear regression of the apparent terminal elimination phase of the serum concentration-versus-time curve.|From Day 1 of Cycle 2 to Day 21 of Cycle 3 for Group 1|Pharmacokinetic (PK) and pharmacodynamic (PD) population: All patients enrolled in the study who had at least 1 evaluable PK or PD sample reading.||µg•hr/mL||Standard Deviation|Mean
809728|NCT01044498|Secondary|Time to Reach Maximum Serum Concentration (Tmax) of Tocilizumab|Blood samples were collected pre-dose and at the end of infusion of tocilizumab on Day 1 of Cycle 2. Additional blood samples were collected on Days 2, 3, 5, 7, 12, 14, 21 of Cycle 2, and Days 1, 7, and 21 of Cycle 3. The concentration of tocilizumab was determined in serum samples using a validated ELISA. The time to reach maximum serum concentration was derived from the serum concentrations using a non-compartmental method with the software WinNonlin Enterprise version 5.2 (or above).|From Day 1 of Cycle 2 to Day 21 of Cycle 3 for Group 1|Pharmacokinetic (PK) and pharmacodynamic (PD) population: All patients enrolled in the study who had at least 1 evaluable PK or PD sample reading.||hr||Standard Deviation|Mean
809729|NCT01044498|Secondary|Maximum Observed Serum Concentration (Cmax) of Tocilizumab|Blood samples were collected pre-dose and at the end of infusion of tocilizumab on Day 1 of Cycle 2. Additional blood samples were collected on Days 2, 3, 5, 7, 12, 14, 21 of Cycle 2, and Days 1, 7, and 21 of Cycle 3. The concentration of tocilizumab was determined in serum samples using a validated enzyme-linked immunosorbent assay (ELISA). The maximum observed plasma concentration (Cmax) was derived from the serum concentrations using a non-compartmental method with the software WinNonlin Enterprise version 5.2 (or above).|From Day 1 of Cycle 2 to Day 21 of Cycle 3 for Group 1|Pharmacokinetic (PK) and pharmacodynamic (PD) population: All patients enrolled in the study who had at least 1 evaluable PK or PD sample reading.||µg/mL||Standard Deviation|Mean
809730|NCT01044498|Secondary|Apparent Oral Clearance (CL/F) of Ethinyl Estradiol and Norethindrone|Blood samples were collected prior to and at 0.5, 1, 1.5, 2, 3, 5, 8, 12 and 24 hours after administration of Ortho-Novum® 1/35 on Day 7 of each cycle. The concentrations of ethinyl estradiol and norethindrone were determined in human heparinized plasma according to a validated gas chromatography coupled to mass spectrometry (GC-MS) method. The apparent oral clearance (CL/F) was derived from the plasma concentrations using a non-compartmental method and computed as dose/AUC0-24 with the software WinNonlin Enterprise version 5.2 (or above).|Day 7 of Cycles 1-3 for Group 1 and Day 7 of Cycle 1 for Group 2|Pharmacokinetic (PK) and pharmacodynamic (PD) population: All patients enrolled in the study who had at least 1 evaluable PK or PD sample reading.||mL/hr||Standard Deviation|Mean
809731|NCT01044498|Secondary|Terminal Half-life (t½) of Ethinyl Estradiol and Norethindrone|Blood samples were collected prior to and at 0.5, 1, 1.5, 2, 3, 5, 8, 12 and 24 hours after administration of Ortho-Novum® 1/35 on Day 7 of each cycle. The concentrations of ethinyl estradiol and norethindrone were determined in human heparinized plasma according to a validated gas chromatography coupled to mass spectrometry (GC-MS) method. The terminal half-life (t½) was derived from the plasma concentrations using a non-compartmental method with the software WinNonlin Enterprise version 5.2 (or above).|Day 7 of Cycles 1-3 for Group 1 and Day 7 of Cycle 1 for Group 2|Pharmacokinetic (PK) and pharmacodynamic (PD) population: All patients enrolled in the study who had at least 1 evaluable PK or PD sample reading.||hr||Standard Deviation|Mean
809732|NCT01044498|Secondary|Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC0-24) of Ethinyl Estradiol and Norethindrone|Blood samples were collected prior to and at 0.5, 1, 1.5, 2, 3, 5, 8, 12 and 24 hours after administration of Ortho-Novum® 1/35 on Day 7 of each cycle. The concentrations of ethinyl estradiol and norethindrone were determined in human heparinized plasma according to a validated gas chromatography coupled to mass spectrometry (GC-MS) method. The area under the plasma concentration-time curve from 0 to 24 hours (AUC0-24) was derived from the plasma concentrations using a non-compartmental method and computed using the linear trapezoidal rule with the software WinNonlin Enterprise version 5.2 (or above).|Day 7 of Cycles 1-3 for Group 1 and Day 7 of Cycle 1 for Group 2|Pharmacokinetic (PK) and pharmacodynamic (PD) population: All patients enrolled in the study who had at least 1 evaluable PK or PD sample reading.||pg•hr/mL||Standard Deviation|Mean
809794|NCT01046396|Secondary|6 Question Subject Cosmetic Acceptability Questionnaire at Week 3|Number of participants in each category (Differin® Lotion, Differin® Cream or No Preference) of each question of the Subject Cosmetic Acceptability Questionnaire at week 3.|week 3|ITT (Intent to Treat)||participants|||Number
824780|NCT01178268|Secondary|Follow-up In-segment Angiographic Binary Restenosis (ABR)||≥13 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|Participants||Number
809733|NCT01044498|Secondary|Time to Reach the Maximum Plasma Concentration (Tmax) of Ethinyl Estradiol and Norethindrone|Blood samples were collected prior to and at 0.5, 1, 1.5, 2, 3, 5, 8, 12 and 24 hours after administration of Ortho-Novum® 1/35 on Day 7 of each cycle. The concentrations of ethinyl estradiol and norethindrone were determined in human heparinized plasma according to a validated gas chromatography coupled to mass spectrometry (GC-MS) method. The time to reach the maximum plasma concentration (Tmax) was derived from the plasma concentrations using a non-compartmental method with the software WinNonlin Enterprise version 5.2 (or above).|Day 7 of Cycles 1-3 for Group 1 and Day 7 of Cycle 1 for Group 2|Pharmacokinetic (PK) and pharmacodynamic (PD) population: All patients enrolled in the study who had at least 1 evaluable PK or PD sample reading.||hr||Standard Deviation|Mean
809734|NCT01044498|Secondary|Maximum Observed Plasma Concentration (Cmax) of Ethinyl Estradiol and Norethindrone|Blood samples were collected prior to and at 0.5, 1, 1.5, 2, 3, 5, 8, 12 and 24 hours after administration of Ortho-Novum® 1/35 on Day 7 of each cycle. The concentrations of ethinyl estradiol and norethindrone were determined in human heparinized plasma according to a validated gas chromatography coupled to mass spectrometry (GC-MS) method. The maximum observed plasma concentration (Cmax) was derived from the plasma concentrations using a non-compartmental method with the software WinNonlin Enterprise version 5.2 (or above).|Day 7 of Cycles 1-3 for Group 1 and Day 7 of Cycle 1 for Group 2|Pharmacokinetic (PK) and pharmacodynamic (PD) population: All patients enrolled in the study who had at least 1 evaluable PK or PD sample reading. Blood samples were not available for all patients at all time points.||pg/mL||Standard Deviation|Mean
809735|NCT01044498|Primary|Serum Progesterone Level|Blood samples were collected prior to the administration of Ortho-Novum® 1/35 on Day 21 of each cycle. Serum levels of progesterone were quantitatively determined using the ADVIA Centaur and ADVIA Centaur XP systems (Siemens Healthcare Diagnostics Inc., Tarrytown, NY, USA). The assay was a competitive immunoassay using direct chemiluminescent technology.|Day 21 of Cycles 1-3 for Group 1 and Day 21 of Cycle 1 for Group 2|Pharmacokinetic (PK) and pharmacodynamic (PD) population: All patients enrolled in the study who had at least 1 evaluable PK or PD sample reading. Blood samples were not available for all patients at all time points.||ng/mL||Standard Deviation|Mean
809736|NCT01044537|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)|AUCinf is the area under the plasma concentration versus time curve from time zero to extrapolated infinite time.|0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose|PK parameter analysis population included all enrolled participants who received study medication and had at least 1 of the PK parameters of interest. Here ‘N' (number of participants analyzed) signifies participants evaluable for this measure.||nanogram*hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
809737|NCT01044537|Secondary|Change From Baseline in Ratio of Insulin Area Under Curve (Insulin AUC) to Glucose Area Under Curve (Glucose AUC) After a Mixed Meal Tolerance Test (MMTT) on Day 1|Ratio of area under the plasma insulin concentration-time curve from time 2 to 6 hrs (in terms of milliunit*deciliter*hour [mU*dL*hour]) to area under the plasma glucose concentration-time curve from time 2 to 6 hrs (in terms of milligram*liter*hour [mg*liter*hour]) was calculated. Linear trapezoidal method was used to compute AUC. The change in ratio from baseline (Day -1) was calculated at Day 1.|-46, -45.75, -45.5, -45, -44.5, -44, -43, -42 hrs pre-dose on Day -1; 2, 2.25, 2.5, 3, 3.5, 4, 5, 6 hrs post-dose on Day 1|PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 of the PD parameters of interest. ‘N' (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies participants evaluable at specified time point for each arm group, respectively.||(mU*dL*hour)/(mg*liter*hour)||Standard Deviation|Mean
809738|NCT01044537|Secondary|Change From Baseline in Ratio of C-peptide Delta C30 to Glucose Delta C30 After a Mixed Meal Tolerance Test (MMTT)|Ratio of C-peptide Delta C30 (in terms of nanogram*deciliter [ng*dL]) to glucose delta C30 (in terms of milligram*milliliter [mg*mL]) was calculated. The change in ratio from baseline (Day -1) was calculated at Day 1.|-46, -45.5 hrs pre-dose on Day -1; 2, 2.5 hrs post-dose on Day 1|PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 of the PD parameters of interest. Here ‘N' (number of participants analyzed) signifies participants evaluable for this measure.||(ng*dL)/(mg*mL)||Standard Deviation|Mean
809739|NCT01044537|Secondary|Change From Baseline in Ratio of Insulin Delta C30 to Glucose Delta C30 After a Mixed Meal Tolerance Test (MMTT) on Day 1|Ratio of insulin delta C30 (in terms of milliunits*deciliter [mU*dL]) to glucose delta C30 (in terms of milligram*liter [mg*liter]) was calculated. The change in ratio from baseline (Day -1) was calculated at Day 1.|-46, -45.5 hrs pre-dose on Day -1; 2, 2.5 hrs post-dose on Day 1|PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 of the PD parameters of interest. Here ‘N' (number of participants analyzed) signifies participants evaluable for this measure.||(mU*dL)/(mg*Liter)||Standard Deviation|Mean
809740|NCT01044537|Secondary|Percent Change From Baseline in Post-Prandial C-peptide Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) on Day 1|Percent change from baseline in post-prandial area under the plasma C-peptide concentration-time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. Baseline value was the AUC (2-6) calculated on Day -1.|-46, -45.75, -45.5, -45, -44.5, -44, -43, -42 hrs pre-dose on Day -1; 2, 2.25, 2.5, 3, 3.5, 4, 5, 6 hrs post-dose on Day 1|PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 of the PD parameters of interest. Here ‘N’ (number of participants analyzed) signifies participants evaluable for this measure.||percent change||Standard Deviation|Mean
809741|NCT01044537|Secondary|Percent Change From Baseline in Post-Prandial Insulin Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) on Day 1|Percent change from baseline in post-prandial area under the plasma insulin concentration-time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. Baseline value was the AUC (2-6) calculated on Day -1.|-46, -45.75, -45.5, -45, -44.5, -44, -43, -42 hrs pre-dose on Day -1; 2, 2.25, 2.5, 3, 3.5, 4, 5, 6 hrs post-dose on Day 1|PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 of the PD parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.||percent change||Standard Deviation|Mean
810722|NCT01048606|Primary|Markers of Oxidative Stress: Conjugated Diene Formation, Malondialdehyde, Alpha-tocopherol and Its Oxidised Form Alpha-tocopheryl Quinone. TAS Constitutes the Most Reliable Method for the Evaluation of Oxidative Stress in Vivo.||6 months||||||
809742|NCT01044537|Secondary|Percent Change From Baseline in Post-Prandial Glucose Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) on Day 1|Percent change from baseline in post-prandial area under the plasma glucose concentration-time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. Baseline value was the AUC (2-6) calculated on Day -1.|-46, -45.75, -45.5, -45, -44.5, -44, -43, -42 hrs pre-dose on Day -1; 2, 2.25, 2.5, 3, 3.5, 4, 5, 6 hrs post-dose on Day 1|PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 of the PD parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.||percent change||Standard Deviation|Mean
809743|NCT01044537|Primary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life (t1/2) is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose|PK parameter analysis population included all enrolled participants who received study medication and had at least 1 of the PK parameters of interest. Here ‘N' (number of participants analyzed) signifies participants evaluable for this measure.||hour||Standard Deviation|Mean
809744|NCT01044537|Primary|Apparent Volume of Distribution (Vz/F)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.|0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose|PK parameter analysis population included all enrolled participants who received study medication and had at least 1 of the PK parameters of interest. Here ‘N' (number of participants analyzed) signifies participants evaluable for this measure.||liter||Geometric Coefficient of Variation|Geometric Mean
809745|NCT01044537|Primary|Apparent Oral Clearance (CL/F)|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose|PK parameter analysis population included all enrolled participants who received study medication and had at least 1 of the PK parameters of interest. Here ‘N' (number of participants analyzed) signifies participants evaluable for this measure.||milliliter per minute (mL/min)||Geometric Coefficient of Variation|Geometric Mean
809746|NCT01044537|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose|PK parameter analysis population included all enrolled participants who received study medication and had at least 1 of the PK parameters of interest.||hour||Full Range|Median
809747|NCT01044537|Primary|Maximum Observed Plasma Concentration (Cmax)||0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose|PK parameter analysis population included all enrolled participants who received study medication and had at least 1 of the PK parameters of interest.||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
809748|NCT01044537|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration-time curve from zero to the last measured concentration (AUClast).|0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose|Pharmacokinetic (PK) parameter analysis population included all enrolled participants who received study medication and had at least 1 of the PK parameters of interest.||nanogram*hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
809749|NCT01044537|Secondary|Change From Baseline in Ratio of C-peptide Area Under Curve (C-peptide AUC) to Glucose Area Under Curve (Glucose AUC) After a Mixed Meal Tolerance Test (MMTT) on Day 1|Ratio of area under the plasma C-peptide concentration-time curve from time 2 to 6 hrs (in terms of nanogram*deciliter*hour [ng*dL*hour]) to area under the plasma glucose concentration-time curve from time 2 to 6 hrs (in terms of milligram*milliliter*hour [mg*mL*hour]) was calculated. Linear trapezoidal method was used to compute AUC. The change in ratio from baseline (Day -1) was calculated at Day 1.|-46, -45.75, -45.5, -45, -44.5, -44, -43, -42 hours pre-dose on Day -1; 2, 2.25, 2.5, 3, 3.5, 4, 5, 6 hours post-dose on Day 1|PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 of the PD parameters of interest. 'N' (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies participants evaluable at specified time point for each arm group, respectively.||(ng*dL*hour)/(mg*mL*hour)||Standard Deviation|Mean
809750|NCT01044537|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study medication and up to 10 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Day 1 up to 10 days after last dose of study medication (up to 11 days)|Safety analysis set included all participants who received at least 1 dose of study medication.||participants|||Number
809751|NCT01044589|Secondary|Number of Participants Reporting a Decrease in Incontinence Episodes Per Week||24 months|||Participants|||Count of Participants
809752|NCT01044589|Primary|Number of Participants Reporting a Decrease in Incontinence Episodes Per Week||12 months|||Participants|||Count of Participants
809753|NCT01045694|Secondary|Strength||twelve weeks, six months, and one year|8 participants were randomized; 2 withdrew voluntarily. Study was terminated due to lack of funds, and unblinding did not occur - it is not known how many participants were placed in each group. Data was not collected or analyzed.|||||
809754|NCT01045694|Secondary|Range of Motion||twelve weeks, six months, and one year|8 participants were randomized; 2 withdrew voluntarily. Study was terminated due to lack of funds, and unblinding did not occur - it is not known how many participants were placed in each group. Data was not collected or analyzed.|||||
809755|NCT01045694|Primary|Pain||twenty-four hours, ten days, twelve weeks, six months, and one year|8 participants were randomized; 2 withdrew voluntarily. Study was terminated due to lack of funds, and unblinding did not occur - it is not known how many participants were placed in each group. Data was not collected or analyzed.|||||
809805|NCT01046695|Secondary|Mean Opioid Use, Converted Into Oral Morphine Equivalents (OME) at 24 and 48 Hours|As subjects could have been prescribed many different analgesics, the amount of pain medication was converted to the standard oral morphine equivalents (OME), so that the mean dose needed could be compared.|24 hours and 48 hours after awakening from video-assisted thoracic surgery|||mg of oral morphine||Standard Deviation|Mean
809756|NCT01045707|Primary|Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)|Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild:no or transient symptoms, no interference with the subject's daily activities. Moderate: marked symptoms, moderate interference with the subject's daily activities. Severe: considerable interference with the subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalisation/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect|Week 0 to Week 53 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||Events/100 years of patient exposure|||Number
809757|NCT01045707|Primary|Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.|Week 0 to Week 53 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||Episodes/100 years of patient exposure|||Number
809758|NCT01045707|Primary|Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 53 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||Episodes/100 years of patient exposure|||Number
809759|NCT01045707|Secondary|Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26|Mean of SMPG at 26 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast.|Week 26|The full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). One subject was excluded from FAS because the subject was randomised in error and was not dosed. For 24 subjects all 9-point SMPG values were missing.||mmol/L||Standard Deviation|Mean
809760|NCT01045707|Secondary|Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment|Change from baseline in HbA1c after 52 weeks of treatment.|Week 0, Week 53|The full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). One subject was excluded from FAS because the subject was randomised in error and was not dosed.||percentage of glycosylated haemoglobin||Standard Deviation|Mean
809761|NCT01045707|Primary|Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment|Change from baseline in HbA1c after 26 weeks of treatment.|Week 0, Week 26|The full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). One subject was excluded from FAS because the subject was randomised in error and was not dosed.||percentage of glycosylated haemoglobin||Standard Deviation|Mean
809762|NCT01045798|Primary|The Proportion of Patients Discontinued From Study Therapy to be Treated With Empirical Antifungal Therapy Outside of the Context of the Study.|"The feasibility of conducting a major randomized study of caspofungin for empirical therapy for invasive candidiasis in high-risk non-neutropenic intensive care unit (ICU) participants was to be assessed by the incidence of study therapy discontinuations due to investigators choosing to treat participants with empirical antifungal therapy outside of the context of this protocol.
Study drug was administered for a minimum of 7 days to a maximum of 14 days provided participants had no evidence of confirmed breakthrough invasive Candida infection while receiving study drug."|1 to 14 days|Of the 114 participants anticipated to enroll in this study, 15 actually enrolled and only 14 received study drug. The participant who did not receive study drug was discontinued; the remaining 14 received at least one dose of study drug, met inclusion/exclusion criteria, and therefore qualified for the full analysis set used for summary analyses.||Participants|||Number
809763|NCT01045967|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
809764|NCT01045967|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
809765|NCT01045967|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Cmax.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
809766|NCT01045993|Secondary|Number of Participants Per Categorical Score for Global Assessment of Study Treatment|At hour 8, or at the time of rescue, if it occurred, participants performed a global assessment in their diary in response to the question: How would you rate the study treatment as a pain reliever? Very Poor=0, Poor=1, Fair=2, Good=3, Very Good=4, Excellent=5.|Baseline (time of wrap application or oral treatment administration) up to 8 hours|ITT population.||participants|||Number
809767|NCT01045993|Secondary|Change From Baseline in Pain Measurement for Flexibility Measure: Rotation|Flexibility assessed using Paris Plinth table with maximum rotation at waist of +/- 30 degrees for L, R movement. When participant feels discomfort or pain, participant places a mark to rate discomfort/pain (maximum) on a VAS of 100 mm in length with 0=no discomfort/no pain up to 100=most discomfort/most pain. Movement decreased 5 degrees (minus) and discomfort rated on VAS. Movement increased 5 degrees (plus) beyond first point when pain was reported and discomfort/pain again rated on the VAS. Analyses based on the average of L, R scores. Higher score indicated greater discomfort/pain.|Baseline (time of wrap application or oral treatment administration) and 4 hours|ITT population.||scores on a scale||Standard Deviation|Mean
809768|NCT01045993|Secondary|Change From Baseline in Pain Measurement for Flexibility Measure: Side-to-Side|Flexibility assessed using Paris Plinth table with maximum side-to-side movement of +/- 10 degrees for L, R movement. When participant feels discomfort or pain, participant places a mark to rate discomfort/pain (maximum) on a VAS of 100 mm in length with 0=no discomfort/no pain up to 100=most discomfort/most pain. Movement decreased 5 degrees (minus) and discomfort rated on VAS. Movement increased 5 degrees (plus) beyond first point when pain was reported and discomfort/pain again rated on the VAS. Analyses based on the average of L, R scores. Higher score indicated greater discomfort/pain.|Baseline (time of wrap application or oral treatment administration) and 4 hours|ITT population.||scores on a scale||Standard Deviation|Mean
809769|NCT01045993|Secondary|Change From Baseline (Bsl) in Pain Measurement for Flexibility Measure: Extension|Flexibility assessed using Paris Plinth table with maximum extension of 20 degrees movement (as if performing a sit-up). When participant feels discomfort or pain, participant places a mark to rate discomfort/pain (maximum) on a VAS of 100 mm in length with 0=no discomfort/no pain up to 100=most discomfort/most pain. Movement decreased 5 degrees (minus) and discomfort rated on VAS. Movement increased 5 degrees (plus) beyond first point when pain was reported and discomfort/pain again rated on the VAS. Higher score indicated greater discomfort/pain.|Baseline (time of wrap application or oral treatment administration) and 4 hours|ITT population.||scores on a scale||Standard Deviation|Mean
809770|NCT01045993|Secondary|Change From Baseline in the Angle Measurement at Maximum Flexion for Flexibility Measures: Rotation|Participant placed in a prone position on Paris Plinth table which is moved at 1 degree per second to maximum rotation at waist of +/- 30 degrees for left, and right, movement to the degree of movement at which participant perceives discomfort or pain. Maximum flexion based on the average of the left and right rotation scores. Higher score indicated greater improvement.|Baseline (time of wrap application or oral treatment administration) and 4 hours|ITT population.||degrees||Standard Deviation|Mean
809771|NCT01045993|Secondary|Change From Baseline in the Angle Measurement at Maximum Flexion for Flexibility Measures: Side-to-Side|Participant placed in a prone position on Paris Plinth table which is moved at 1 degree per second to maximum movement +/- 10 degrees for left, and right, side-to-side movement to the degree of movement at which participant perceives discomfort or pain. Maximum flexion based on the average of the left and right side-to-side scores. Higher score indicated greater improvement.|Baseline (time of wrap application or oral treatment administration) and 4 hours|ITT population.||degrees||Standard Deviation|Mean
809772|NCT01045993|Secondary|Change From Baseline in the Angle Measurement at Maximum Flexion for Flexibility Measures: Extension|Participant placed in a prone position on Paris Plinth table which is moved at 1 degree per second to maximum movement of 20 degrees for extension (as if performing a sit-up) to the degree of movement at which participant perceives discomfort or pain. Higher score indicated greater improvement.|Baseline (time of wrap application or oral treatment administration) and 4 hours|ITT population.||degrees||Standard Deviation|Mean
809773|NCT01045993|Secondary|Change From Baseline (Bsl) in Overall Combined Flexibility Score: Rotation|Flexibility assessed using Paris Plinth table with maximum rotation at waist of plus or minus (+/-) 30 degrees for left, and right (L, R), movement. Angle at Bsl and at 4 hours standardized to 100 for assessment of maximum angle (x degrees), x degrees - 5, and x degrees + 5. Flexibility score derived using standardized value and VAS score (participant rating of level of pain on 100 mm line 0=no pain up to 100=worst pain). Final derived data for overall flexibility were the average of rotation (L, R) flexibility data on combined score (range -80 to 155); higher value=greater improvement.|Baseline (time of wrap application or oral treatment administration) and 4 hours|ITT population.||scores on a scale||Standard Deviation|Mean
809774|NCT01045993|Secondary|Change From Baseline (Bsl) in Overall Combined Flexibility Score: Side-to-Side|Flexibility assessed using Paris Plinth table with maximum side-to-side movement of plus or minus (+/-) 10 degrees for left, and right (L, R), movement. Angle at Bsl and 4 hours standardized to 100 for assessment of maximum angle (x degrees), x degrees - 5, and x degrees + 5. Flexibility score derived using standardized value and VAS score (participant rating of level of pain on 100 mm line 0=no pain to 100=worst pain). Final derived data for overall flexibility was the average of side-to-side (L, R) flexibility data on the combined score (range -81 to 264); higher value=greater improvement.|Baseline (time of wrap application or oral treatment administration) and 4 hours|ITT population.||scores on a scale||Standard Deviation|Mean
809775|NCT01045993|Secondary|Change From Baseline (Bsl) in Combined Flexibility Score: Extension|Flexibility assessed using Paris Plinth table with maximum extension (as if performing a sit-up) of 20 degrees movement. Angle at Bsl and at 4 hours standardized to 100 for assessment of maximum angle (x degrees), x degrees minus 5, and x degrees plus 5. Flexibility score derived using standardized value and VAS score (participant rating of pain by marking level of pain on 100 mm line 0=no pain up to 100=worst pain). Final derived data for extension flexibility were average of the extension flexibility data on the combined score (range -66 to 552); higher value indicated greater improvement.|Baseline (time of wrap application or oral treatment administration) and 4 hours|ITT population.||scores on a scale||Standard Deviation|Mean
809776|NCT01045993|Secondary|Change From Baseline in Individual Time-point Back Stiffness Scores|Low back muscle stiffness rated hourly (from baseline) by the participant by placing a line on a visual analog scale (VAS) from 0 millimeters (mm) to 100 mm in length with 0=no muscle stiffness up to 100 (most possible stiffness).|At 60, 120, 180, 240, 300, 360, 420, and 480 minutes|ITT population.||scores on a scale||Standard Deviation|Mean
809777|NCT01045993|Secondary|Individual Time-Point Pain Relief Scores|Pain relief rated hourly (from baseline) by the participant on a 6-point scale: 0=no relief, 1=a little relief, 2=less than half relief, 3=more than half relief, 4=a lot of relief, 5=complete relief.|At 60, 120, 180, 240, 300, 360, 420, and 480 minutes|ITT population.||scores on a scale||Standard Deviation|Mean
809778|NCT01045993|Secondary|Time to Treatment Failure|Time to treatment failure defined as time from dosing to the time of rescue medication within the scheduled duration of the study (8 hours); or for participants who withdrew from the study due to lack of efficacy without taking rescue medication, the time of the last assessment was considered the time to treatment failure; or if participant did not take rescue medication, or did not discontinue due to lack of efficacy, the time to treatment failure was considered censored at 8 hours (the scheduled duration of the study).|Baseline (time of wrap application or oral treatment administration) up to 8 hours|ITT population. Time to treatment failure not calculable as there were no treatment failures in this study. No participants required use of rescue medication or discontinued study prior to 8 hour evaluation.|||||
809779|NCT01045993|Secondary|Time Weighted Sum of Change From Baseline in the Back Stiffness Score Over 8 Hours|Time weighted sum of change calculated as sum of change from baseline in back stiffness scores from 0 through 8 hours, weighted by time duration between current timepoint and previous timepoint. Based on hourly (from baseline) back stiffness assessment rating from 0 (no muscle stiffness) to 100 (most possible muscle stiffness). Sum of change derived by subtracting score at post-dosing time point from baseline score. Total possible score -800 to 800; higher positive value was indicative of greater improvement.|Baseline (time of wrap application or oral treatment administration) up to 8 hours|ITT population.||scores on a scale||Standard Deviation|Mean
809780|NCT01045993|Secondary|Time Weighted Sum of Pain Relief From 0 Through 8 Hours (TOTPAR 0-8)|TOTPAR 0-8 sum of pain relief from 0 through 8 hours, weighted by the time duration between the current timepoint and the previous timepoint. Pain relief rated hourly (from baseline) by the participant on a 6-point scale: 0=no relief, 1=a little relief, 2=less than half relief, 3=more than half relief, 4=a lot of relief, 5=complete relief. Total possible score 0 to 40; higher score indicated better relief.|Baseline (time of wrap application or oral treatment administration) up to 8 hours|ITT population.||scores on a scale||Standard Deviation|Mean
809781|NCT01045993|Primary|Time to First Perceptible Relief (Confirmed by Meaningful Relief)|"“First perceptible relief” defined as the elapsed time from wrap application or oral treatment until the participant depressed the first stopwatch labeled “first perceptible relief” (any pain relieving effect), provided the participant also depressed the second stopwatch labeled meaningful relief” (meaningful to participant) by the end of the scheduled in-patient evaluation (4 hours / 240 minutes). If the confirmation was not achieved, the participant was censored at the time when the first stopwatch was depressed. Confidence interval (CI) calculated using the method of Simon & Lee."|Baseline (time of wrap application or oral treatment administration) up to 4 hours|Intent-to-treat population (ITT): all randomized participants who applied/dosed with study product and had a baseline assessment. Median and/or upper limit of CI reported as 240 minutes if >240 minutes. No primary endpoint was prespecified in this Pilot study; 1 key efficacy endpoint was selected for reporting purposes only.||minutes||95% Confidence Interval|Median
809782|NCT01045993|Secondary|Time to Meaningful Relief|Time to “meaningful relief” defined as elapsed time from start of treatment until participant depressed the second stopwatch indicating “meaningful relief” (meaningful to participant). Participant consider censored if participant did not depress the stopwatch by end of 4-hour in-patient evaluation, or became a treatment failure (rescue or discontinuation) during the time prior to depressing the second stopwatch. Censoring was at time of dropout if participant withdrew for non-efficacy related reasons during the 4-hour in-patient portion of the study. CI calculated using method of Simon & Lee.|Baseline (time of wrap application or oral treatment administration) up to 4 hours|ITT population. Median and/or upper limit of CI reported as 240 minutes if median or upper limit >240 minutes.||minutes||95% Confidence Interval|Median
809783|NCT01046084|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 14 hour period.|All participants that completed the study had their samples analyzed. Replicate study design allowed for 2 sets of samples per subject per treatment (N=96 for both test and reference).||ng*h/mL||Standard Deviation|Mean
809784|NCT01046084|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 14 hour period.|All participants that completed the study had their samples analyzed. Replicate study design allowed for 2 sets of samples per subject per treatment (N=96 for both test and reference).||ng*h/mL||Standard Deviation|Mean
809785|NCT01046084|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Cmax.|Blood samples collected over a 14 hour period.|All participants that completed the study had their samples analyzed. Replicate study design allowed for 2 sets of samples per subject per treatment (N=96 for both test and reference).||ng/mL||Standard Deviation|Mean
809786|NCT01046110|Secondary|Change in Fasting Plasma Glucose (FPG)|Change from baseline in FPG after 26 weeks of treatment|Week 0, Week 26|The FAS included all randomised subjects and missing data was imputed using LOCF. One site was closed, hence 11 randomised subjects (4 in IDeg and 7 in DPP-IV group/arm) were excluded from the FAS. Fasting plasma glucose values were missing for another 8 subjects, hence did not contribute to the analysis.||mmol/L||Standard Deviation|Mean
809787|NCT01046110|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Change from baseline in HbA1c after 26 weeks of treatment|Week 0, Week 26|The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF). A site was closed, hence 11 randomised subjects (4 subjects with IDeg; 7 subjects with DPP-IV group/arm) were excluded from the FAS.||percentage of glycosylated haemoglobin||Standard Deviation|Mean
809788|NCT01046136|Primary|Mean Change From Baseline in a 6 Point Severity Scale (0 = None, 1 = Very Mild, 2 = Mild or Slight, 3 = Moderate, 4 = Severe or 5 = As Bad as it Can be) for Cough.|Mean change from baseline in a 6 point severity scale between treatment groups(0 = None, 1 = Very mild, 2 = Mild or slight, 3 = Moderate, 4 = Severe or 5 = As bad as it can be) for cough.|Baseline and Day 4|||units on a scale||Standard Deviation|Mean
809789|NCT01046136|Secondary|Number of Patients With Adverse Events|Total number of patients with adverse events that were possibly or probably related.|7 days|All participants who received study medication, excluding participants who later returned all the dispensed study medication to the site unused.||participants|||Number
809790|NCT01046136|Primary|Investigator's End of Study Assessment of Treatment|Yes the investigator would use this treatment for cold symptoms in the future.|7 days|MITT defined as all participants receiving at least 1 dose of study medication and had 1 or more efficacy assessment after Baseline. Last observation carried forward method was applied to missing post baseline measurement in the analyses of the MITT population.||participants|||Number
809791|NCT01046253|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed. Replicate study design allowed for 2 sets of samples per subject per treatment (N=96 for both test and reference).||ng*h/mL||Standard Deviation|Mean
809792|NCT01046253|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed. Replicate study design allowed for 2 sets of samples per subject per treatment (N=96 for both test and reference).||ng*h/mL||Standard Deviation|Mean
809795|NCT01046396|Primary|Number of Participants Who Were a Success With Regard to Worst Post-baseline Tolerability Assessment Scores in Each Category of the Tolerability Assessments (Erythema, Scaling, Dryness, Stinging/Burning) From Baseline to Week 3.|Number of participants who were a success with regard to worst post-baseline tolerability assessment scores in each category of the tolerability assessments from baseline to week 3. Tolerability assessments (erythema, scaling, dryness, stinging/burning) are evaluated on a scale from 0 – 4 (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) with 0 being best and 4 being worst. Success for each category was defined as a tolerability score of 0.|baseline to week 3|Per protocol||participants|||Number
809796|NCT01046565|Secondary|6 Question Subject Cosmetic Acceptability Questionnaire|Number of participants in each category (Differin® Lotion, Differin® Cream or No Preference) for each question of the Subject Cosmetic Acceptability Questionnaire at week 3.|week 3|ITT (Intent to Treat)||participants|||Number
809797|NCT01046565|Primary|Number of Participants Who Were a Success With Regard to Worst Post-baseline Tolerability Assessment Scores in Each Category of the Tolerability Assessments (Erythema, Scaling, Dryness, Stinging/Burning) From Baseline to Week 3.|Number of participants who were a success with regard to worst post-baseline tolerability assessment scores in each category of the tolerability assessments from baseline to week 3. Tolerability assessments (erythema, scaling, dryness, stinging/burning) are evaluated on a scale from 0 – 4 (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) with 0 being best and 4 being worst. Success for each category was defined as a tolerability score of 0.|baseline to week 3|Per protocol||participants|||Number
809798|NCT01046643|Secondary|Neuropsychological Testing Scores - Visual Learning Retention|"Changes in neuropsychological testing measures (visual learning retention) with hormone use (either estradiol or progesterone) versus placebo.
Subjects are given tests that present them with a series of pictures. They are asked to recall how many items they can remember, and then some time later, are asked to recall the items again. The retention measure is how many items they can remember at the later time point, compared to the earlier time point. Adapted from the California Verbal Learning Test - 2nd edition.
The tests were administered 3 months after baseline and 38 weeks after baseline."|August 2010 - March 2012|Within the Estrogen/Placebo groups, 3 participants were unable to complete the needed fMRI analyses due to adverse events, and in the Progesterone/Placebo groups, 1 participant's fMRI scans were damaged.||percent retention||Standard Deviation|Mean
809799|NCT01046643|Primary|Changes in Brain Activation Patterns in Visual Tasks Determined With the Functional Magnetic Resonance Imaging (fMRI) Scans|"Measure the changes in brain activity in visual tasks with hormone use (either estradiol or progesterone) versus placebo.
The test is a visual working memory task, where the women are presented with 3 geometric grids on the screen. The target grid is on top, and 2 test grids are on the bottom. The women must decide if the right or left test grid matches the grid on top. There are 3 conditions: a match condition where all 3 grids are shown simultaneously, and 2 delay conditions, where the target grid is shown first, disappears, and the test grids appear after a 1 or a 4 second delay.
The test was administered 3 months after baseline and 38 weeks after baseline."|August 2010 - March 2012|Within the Estrogen/Placebo groups, 3 participants were unable to complete the needed fMRI analyses due to adverse events, and in the Progesterone/Placebo groups, 1 participant's fMRI scans were damaged.||percent BOLD signal changes||Standard Deviation|Mean
809800|NCT01046643|Secondary|Neuropsychological Testing Scores - Verbal Learning Retention|"Changes in neuropsychological testing measures (verbal learning retention) with hormone use (either estradiol or progesterone) versus placebo.
Subjects are given tests that present them with a series of words. They are asked to recall how many items they can remember, and then some time later, are asked to recall the items again. The retention measure is how many items they can remember at the later time point, compared to the earlier time point. Adapted from the Benton Visual Memory Test, Revised.
The tests were administered 3 months after baseline and 38 weeks after baseline."|August 2010 - March 2012|Within the Estrogen/Placebo groups, 3 participants were unable to complete the needed fMRI analyses due to adverse events, and in the Progesterone/Placebo groups, 1 participant's fMRI scans were damaged.||percent retention||Standard Deviation|Mean
809801|NCT01046643|Primary|Changes in Brain Activation Patterns in Verbal Tasks Determined With the Functional Magnetic Resonance Imaging (fMRI) Scans|"Measure the changes in brain activity in verbal tasks with hormone use (either estradiol or progesterone) versus placebo.
The test is a deep and shallow verbal processing task, where the subjects are presented lists of words, one word at a time, and are asked to make one of 2 decisions about each list. One decision is whether each word is written in upper or lower case letters (shallow processing), and the other decision is whether each word denotes an abstract or concrete concept (deep processing).
The test was administered 3 months after baseline and 38 weeks after baseline."|August 2010 - March 2012|Within the Estrogen/Placebo groups, 3 participants were unable to complete the needed fMRI analyses due to adverse events, and in the Progesterone/Placebo groups, 1 participant's fMRI scans were damaged and unable to be used in the analysis.||percent BOLD signal changes||Standard Deviation|Mean
809802|NCT01046682|Primary|Change in Flow Mediated Dilation (FMD) of the Brachial Artery Measured by Ultrasound Over 13 Weeks|Flow mediated dilation (FMD) of the brachial artery was measured by ultrasound. This is a measure of endothelial dependent endothelial cell function. Flow mediated dilation is expressed as a percent change from baseline brachial artery diameter to brachial artery diameter after reactive hyperemia. Reactive hyperemia occurred after occluding the brachial artery with a blood pressure cuff for 5 minutes.|Entry and week 13 visits|Number of participants for analysis was determined by the number of participants that had 2 FMD tests performed||% change from baseline||Inter-Quartile Range|Median
809803|NCT01046695|Primary|Mean Pain Score|Pain was measured by using the Visual Analog Scale (VAS) with a range from 1-10; with 0 being no pain and 10 being severe pain. Pain scores were measured from hour 1 to hour 48 for each patient. Some scores were missed when patients were asleep. In these cases, the previous score was used.|hour 1 to hour 48 after awakening from video-assisted thoracic surgery|||units on a scale||Standard Deviation|Mean
809804|NCT01046695|Secondary|Satisfaction With Pain Control at 48 Hours|Pain control was measured by using a Visual Analog Scale (VAS) with a range from 0-10; with 0 being very satisfied and 10 being very dissatisfied.|48 hours after awakening from video-assisted thoracic surgery|11 participants on each arm did not complete the VAS.||participants|||Number
810404|NCT01044758|Secondary|Behavioral Performance as Assessed in the Functional Magnetic Resonance Imaging (fMRI) Memory Task|Mnemonic similarity task which assesses long term memory function. Scale ranges from 0-100 with higher scores indicating better memory performance.|2 weeks|||percent correct recalled||Standard Error|Mean
809806|NCT01046877|Secondary|Percentage of Ears With Adverse Events|This outcome measure evaluates occurrence of new adverse events since prior follow-up visit. (non-cumulative)|12 months post procedure|One subject was lost to follow-up following the procedure. 2 subjects were lost to follow-up after the 30 day visit. 2 subjects were lost to follow-up after the 3 month visit. 3 subjects were lost to follow-up following the 6 month visit. 4 subjects were lost to follow-up after the 9 month visit and 2 subjects missed the 12 month visit.||percentage of ears|Participants|95% Confidence Interval|Number
809807|NCT01046877|Secondary|Percentage of Ears With Adverse Events|This outcome measure evaluates occurrence of new adverse events since prior follow-up visit. (non-cumulative)|9 months|One subject was lost to follow-up immediately following the procedure. Two subjects were lost to follow-up after the 30 day visit. Two subjects were lost to follow-up after the 3 month visit. Three additional subjects were lost to follow-up following the 6 month visit and one subject missed the 9 month visit.||percentage of ears|Participants|95% Confidence Interval|Number
809808|NCT01046877|Secondary|Percentage of Ears With Adverse Events|This outcome measure evaluates occurrence of new adverse events since prior follow-up visit. (non-cumulative)|6 months|One subject was lost to follow-up immediately following the procedure. Two subjects were lost to follow-up after the 30 day visit. Two additional subjects were lost to follow-up after the 3 month visit and two subject missed the 3 month visit.||percentage of ears|Participants|95% Confidence Interval|Number
809809|NCT01046877|Secondary|Percentage of Ears With Adverse Events|This outcome measure evaluates occurrence of new adverse events since prior follow-up visit. (non-cumulative)|3 months|One subject was lost to follow-up immediately following the procedure. Two additional subjects were lost to follow-up after the 30 day visit and one subject missed the 30 day visit.||percentage of ears|Participants|95% Confidence Interval|Number
809810|NCT01046877|Secondary|Percentage of Ears With Adverse Events|This outcome measure evaluates occurrence of new adverse events since prior follow-up visit. (non-cumulative)|30 days|One subject was lost to follow-up immediately following the procedure.||percentage of ears|Participants|95% Confidence Interval|Number
809811|NCT01046877|Secondary|Percentage of Patent Tubes|This measure assesses the patency (openness or lack of obstruction) of unextruded tubes.|9 Months|3 subjects lost to follow-up after 6 mo visit. 1 subject missed 9 mo visit. 2 subjects lost to follow-up after 3 mo visit. 2 subjects lost to follow-up after 30 day visit. 1 subject lost to follow-up following procedure. Thus, only 3 ears (= 3 participants) of 16 participants returning at 9 mos had unextruded tubes for assessment of patency.||percentage of tubes|Participants|95% Confidence Interval|Number
809812|NCT01046877|Secondary|Percentage of Patent Tubes|This measure assesses the patency (openness or lack of obstruction) of unextruded tubes.|6 months|Two subjects lost to follow-up after 3 month visit. Two subjects missed 6 month visit. Two subjects lost to follow-up after 30 day visit. One subject lost to follow-up immediately following procedure. Thus, only 13 ears (= 9 participants) of 18 participants returning at 6 months had unextruded tubes for assessment of patency.||percentage of tubes|Participants|95% Confidence Interval|Number
809813|NCT01046877|Secondary|Percentage of Patent Tubes|This measure assesses the patency (openness or lack of obstruction) of unextruded tubes.|3 months|Two subjects were lost to follow-up after the 30 day visit and one subject missed the 3 month visit. One subject was lost to follow-up immediately following the procedure. Thus, only 28 ears of 21 participants had unextruded tubes for assessment of tube patency.||percentage of tubes|Participants|95% Confidence Interval|Number
809814|NCT01046877|Secondary|Percentage of Patent Tubes|This measure assesses the patency (openness or lack of obstruction) of unextruded tubes.|30 days|One subject (one ear) was lost to follow-up immediately following the procedure.||percentage of tubes|Participants|95% Confidence Interval|Number
809815|NCT01046877|Secondary|Percentage of Tympanostomy Tubes Extruded at 12 Months Post Procedure||12 months|Over the course of 12 months, a total of 17 subjects (25 ears) were assessed at varying follow-up time points as having had tubes extruded. Ears analyzed included those for which a tube was observed to extrude at any follow-up visit and ears that completed the 12 month visit.||percentage of tubes|Participants|95% Confidence Interval|Number
809816|NCT01046877|Primary|Percentage of Ears Treated Successfully With the TTDS in the Absence of Acute Intraprocedural Adverse Events.|TTDS success will be confirmed by the successful delivery of a tube to the tympanic membrane.|Procedural|One subject was missing data on intraprocedural adverse events and is excluded from this analysis.||percentage of ears|Participants|95% Confidence Interval|Number
809817|NCT01046903|Other Pre-specified|Number of Participants With Hematoma|Hematoma is a localized collection of blood outside of a blood vessel. It includes subcutaneous hematoma and injection-site hematoma.|Baseline up to Week 5|The Safety Analysis Set included all those participants who received at least 1 dose of the study medication.||Participants|||Number
809818|NCT01046903|Other Pre-specified|Number of Participants Compliant With the Treatment|Compliance was defined as participants documented with Dalteparin Sodium up to 5 weeks after initiation of thromboprophylaxis.|Baseline up to Week 5|Data was collected but not statistically summarized for analysis.||Participants|||Number
809819|NCT01046903|Other Pre-specified|Administration Schedule of Treatment|Administration schedule for Fragmin in major orthopedic surgery Included was categorized as; (1): first dose of Fragmin 5000 IU in the evening before the day of surgery, followed by daily doses of 5000 IU up to 5 weeks; (2): first dose of Fragmin 2500 IU 2 hours before surgery, and a second dose of 2500 IU 8 to 12 hours later, not earlier than 4 hours after surgery, followed by daily doses of 5000 IU up to 5 weeks or (3): first dose of Fragmin 2500 IU 4 to 8 hours postoperatively, followed by daily doses of 5000 IU up to 5 weeks.|Baseline up to Week 5|The Safety Analysis Set included all those participants who received at least 1 dose of the study medication.||Participants|||Number
809820|NCT01046903|Primary|Physician's Assessment of Efficacy of Treatment|Efficacy of treatment as assessed by physician was evaluated on the 5 point categorical scale: excellent, very good, good, fair, poor.|Baseline up to Week 5|The Full Analysis Set (FAS) included all those participants who received at least 1 dose of the study medication.||Participants|||Number
809821|NCT01046903|Other Pre-specified|Physician's Assessment of Tolerability of Treatment|Tolerability of treatment as assessed by physician was evaluated on the five point categorical scale: excellent, very good, good, fair, poor.|Baseline up to Week 5|The Safety Analysis Set included all those participants who received at least 1 dose of the study medication.||Participants|||Number
810723|NCT01048606|Primary|Glucose Metabolism: 2h-75g Oral Glucose Tolerance Test (OGTT) + Plasma Insulin and Glucose Concentrations (Blood Sample Analysis).||12 months||||||
809822|NCT01046903|Other Pre-specified|Participant's Global Evaluation of Treatment|Participant's global evaluation of treatment for overall response and comfort was evaluated on the four point categorical scale: excellent, good, fair and poor.|Baseline up to Week 5|The Safety Analysis Set included all those participants who received at least 1 dose of the study medication.||Participants|||Number
809823|NCT01046903|Other Pre-specified|Number of Participants With Bleeding|Major bleeding: defined as fatal bleeding, clinically overt bleeding causing a fall in hemoglobin more than or equal to 20 gram/litre (g/L) (2 g/decilitre [dL]), clinically overt bleeding leading to transfusion of more than or equal to 2 units of whole blood or red cells, or symptomatic bleeding in areas of special concern (intracranial, retroperitoneal, intraocular, intraspinal, pericardial, intramuscular with compartmental syndrome, or intraarticular). Minor bleeding was defined as bleeding that did not meet the definition of major bleeding.|Baseline up to Week 5|The Safety Analysis Set included all those participants who received at least 1 dose of the study medication.||Participants|||Number
809824|NCT01046903|Other Pre-specified|Number of Participants With Thromboembolism|Thromboembolism is the formation of blood clot in the blood vessels due to an embolus (a detached intravascular mass capable of clogging arterial capillary beds at a site far from its origin).|Baseline up to Week 5|The Safety Analysis Set included all those participants who received at least 1 dose of the study medication.||Participants|||Number
809825|NCT01046903|Other Pre-specified|Number of Participants With Risk Factors|Risk factors evaluated for vascular thromboembolism (VTE) were age (above 40 years, but age was not a strong risk factor as a prediction of potential VTE episode), gender (primarily females but males after 65 years also influenced VTE episode), obesity, pregnancy, liver disease, kidney disease, hormone therapy, immobilization, previous surgery, concomitant malignant disease, positive family history, varicose veins, smoking, chemotherapy, catheter in vein, Heart Failure III New York Heart Association (NYHA) and Heart Failure IV NYHA.|Baseline|The Safety Analysis Set included all those participants who received at least 1 dose of the study medication.||Participants|||Number
809826|NCT01046903|Other Pre-specified|Participant's Dosage Regimen|Approved dosage regimens for Fragmin in major orthopedic surgery included; (1): first dose of Fragmin 5000 IU in the evening before the day of surgery, followed by daily doses of 5000 IU up to 5 weeks; (2): first dose of Fragmin 2500 IU 2 hours before surgery, and a second dose of 2500 IU 8 to 12 hours later, not earlier than 4 hours after surgery, followed by daily doses of 5000 IU up to 5 weeks or (3): first dose of Fragmin 2500 IU 4 to 8 hours postoperatively, followed by daily doses of 5000 IU up to 5 weeks.|Baseline up to Week 5|The Safety Analysis Set included all those participants who received at least 1 dose of the study medication.||Participants|||Number
809827|NCT01047189|Secondary|The Change (Dynamic Assessment) From Baseline to Week 12 (or End of Treatment) in Total Acne Lesion Count||Baseline to 12 weeks|All patients were analyzed up to end of treatment or last visit.||percentage of lesions||95% Confidence Interval|Mean
809828|NCT01047189|Primary|Measured Adherence to ZIANA Gel or Generic Topical Clindamycin 1% Gel Each Morning Plus Generic Topical Tretinoin 0.025% Cream Each Evening in Subjects With Mild to Moderate Acne|Percentage of prescribed doses taken as measured by a Medication Event Monitoring System (MEMS) cap|12 weeks|All patients were analyzed up to end of treatment or last visit.||Percent of doses||Full Range|Median
809829|NCT01047241|Primary|Time to Maximum Plasma Concentrations (Tmax) Sufentanil and Ketamine||Time=5-60 min after administration of investigational medicinal product|||minutes||Standard Deviation|Mean
809830|NCT01047241|Primary|Bioavailability of Sufentanil and Ketamine||Time= 5-60 min after administration of the investigational medical product|||percentage bioavailable||Standard Error|Mean
809831|NCT01047241|Secondary|Acceptance of Intranasal Administration|Asking the children (parents for preverbal children) if they would like to receive this treatment again in a similar situation rather than analgesic suppositories, tablets, oral solutions, or injections?|Immediately after the procedure|||percentage of participants|||Number
809832|NCT01047241|Secondary|Sedation Score (UMSS)|"University of Michigan Sedation Score (UMSS) (0-4, 0 awake and alert, 4 unarousable)"|Time= 0-70 min. after drug administration|||units on a scale||Full Range|Median
809833|NCT01047241|Primary|Maximum Plasma Concentration (Cmax) of Sufentanil and Ketamine||Time= 5-60 min after administration of the investigational medical product|||mcg/L||Standard Deviation|Mean
809834|NCT01047241|Primary|Procedural Pain Intensity Score|Children <5 years old were administered the FLACC (Face Leg Activity Cry Consolability) Scale (Range: 0-10, where 0 is no pain and 10 is worst pain). Children >= 5 years but < 8 years old were administered the Visual analog scale modified with six faces by Wong-Baker (Wong-Baker Faces Pain Rating Scale) (Range: 0-10, where 0 is no pain and 10 is worst pain). Children >= 8 years old were administered a Visual Analog Scale (Range: 0-10, where 0 is no pain and 10 is worst pain).|Pain assessment during painful medical procedure|||units on a scale||Inter-Quartile Range|Median
809835|NCT01047293|Primary|Evaluate Safety of the Combination at a Daily Dosing of 2.5mg RAD001, 5 mg RAD001 or 10 mg RAD001 (Phase 1 Part)|Number of patients who experienced a Dose Limiting Toxicity (DLT). DLT will be assessed in the first 28 days of dosing. Patients need to get dosed with 2 rounds/sessions of all chemotherapy agents in the first 28 days in order to be evaluable for DLT assessment. The primary endpoint is safety as summarized by dose limiting toxicity (DLT).|December 2011|||participants|||Number
809836|NCT01047293|Primary|Progression Free Survival at Six Months||6 months|Progression free survival at six month was calculated using all patients receiving one dose of drug therapy at all of the different dosing levels. The six month progression free survival was determined using Kaplan Meier methods||percentage of participants||95% Confidence Interval|Number
809837|NCT01047306|Other Pre-specified|Change From Baseline in Phosphorylated Tau Levels in Cerebrospinal Fluid (CSF)|Tau proteins are involved in the building and stabilization of axonal microtubules in the CNS. The phosphorylation of tau proteins associated with microtubules is believed to be involved in destabilizing axons and extensively phosphorylated tau (ptau) has been observed in patients with Alzheimer disease and other neurodegenerative diseases. Because MPS IIIA is a neurodegenerative disease, CSF phosphorylated tau levels were determined to evaluate the potential role of this process in the natural history of the disease. A negative value indicates that phosphorylated tau levels decreased.|Baseline, 6 months, 12 months, and End of Study (Month 24 assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients at all time points.||picograms/milliliter||Standard Deviation|Mean
809838|NCT01047306|Other Pre-specified|Change From Baseline in Total Tau Levels in Cerebrospinal Fluid (CSF)|Tau proteins are involved in the building and stabilization of axonal microtubules in the CNS. The phosphorylation of tau proteins associated with microtubules is believed to be involved in destabilizing axons and extensively phosphorylated tau (ptau) has been observed in patients with Alzheimer disease and other neurodegenerative diseases. Because MPS IIIA is a neurodegenerative disease, CSF tau levels were determined to evaluate the potential role of this process in the natural history of the disease. A negative value indicates that total tau levels decreased.|Baseline, 6 months, 12 months, and End of Study (Month 24 assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients at all time points.||picograms/milliliter||Standard Deviation|Mean
809839|NCT01047306|Secondary|Change From Baseline in The Total Sleep Disturbance (TSD) Score of The Children’s Sleep Habits Questionnaire (CSHQ)|The CSHQ is a validated, retrospective, parent-reported sleep screening tool. The questionnaire consists of 35 items that yield a TSD score, as well as 8 subscale scores, including bedtime resistance, sleep duration, parasomnias, sleep disordered breathing, night wakings, daytime sleepiness, sleep anxiety, and sleep onset delay. The questionnaire was designed for children aged 4 to 12 years. Parents were asked to think of a recent “typical” week of their child’s sleep and to indicate how often sleep disturbance behaviors occurred. A 3-point scale was used for rating: “usually” if the sleep behavior occurs 5 to 7 times per week, “sometimes” for 2 to 4 times per week, and “rarely” for once or not at all during the week. The TSD score, which is the sum of all responses, included all items of the 8 subscales, but consisted of only 33 items because two on the bedtime resistance and sleep anxiety subscales were identical (range: 0, 99). A negative value indicates less sleep disturbance.|Baseline, 6 months, 12 months, and End of Study (Month 24 assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients at all time points.||units on a scale||Standard Deviation|Mean
809840|NCT01047306|Secondary|Change From Baseline in The Infant Toddler Quality of Life Questionnaire (ITQoL) Growth And Development Subscale|The ITQoL Questionnaire is a generic, validated health status measure for children aged 2 months up to 5 years, including items and scales to measure aspects of physical functioning, development, pain, mood, behavior, general health, and impact on parents. In this study the ITQoL was also administered to patients who were developmentally functioning at or below the age of years. Growth and development is one of 12 health concepts measured by ITQoL. Transformed scores for all subscales range from 0 to 100, with a higher score indicating better health. A positive value indicates improvement.|Baseline, 6 months, 12 months, and End of Study (Month 24 assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients at all time points.||units on a scale||Standard Deviation|Mean
809841|NCT01047306|Secondary|"Number of Participants With Somewhat or Much Worse Change in Health as Assessed by The Child Health Questionnaire Parent Form 50 (CHQ-PF50)"|The parent form, CHQ-PF50, is designed to measure the physical and psychosocial well-being of children 5 years and older. In this trial it was used to assess the health of children 5 to 18 years of age. It consists of 13 health concepts including 11 multi-item and 2 single-item scales: physical function, role/social-emotional/behavioral, role/social-physical, bodily pain, general behavior, mental health, self-esteem, general health perceptions, change in health, parental impact-emotional, parental impact-time, family activities, and family cohesion. The parental impact scales capture the amount of emotional distress and time limitation experienced by the parent due to the child’s physical health, emotional well-being, attention/learning abilities, ability to get along with others, and general behavior. The Change in Health section assesses changes in health over the previous year.|Baseline, 6 months, 12 months, and End of Study (Month 24 assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients at all time points.||participants|||Number
809842|NCT01047306|Post-Hoc|Change From Baseline in Spleen Volume as Assessed by Abdominal Magnetic Resonance Imaging (MRI)|Spleen volume was assessed via abdominal MRI. A negative value indicates that volume decreased.|Baseline, 6 months, 12 months, and End of Study (Month 24 assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients at all time points.||milliliters||Standard Deviation|Mean
809843|NCT01047306|Post-Hoc|Change From Baseline in Liver Volume as Assessed by Abdominal Magnetic Resonance Imaging (MRI)|Liver volume was obtained via abdominal MRI. A negative value indicates that volume decreased.|Baseline, 6 months, 12 months, and End of Study (Month 24 assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients at all time points.||milliliters||Standard Deviation|Mean
809844|NCT01047306|Post-Hoc|Change From Baseline in The Ratio of Mitral Valve Early Inflow Velocity (E) to Late Inflow Velocity (A)|ECG allows a non-invasive assessment of cardiac structure, function, and hemodynamics and can provide essential insight into mechanisms of disease and therapeutic benefit. Blood flow through the mitral valve is measured during one heartbeat.The E/A ratio measures the relationship between early (E) and late (A) inflow velocity by dividing E by A. A positive value indicates that either early flow through the mitral valve (E) increased or late flow through the valve (A) decreased.|Baseline, 6 months, 12 months, End of Study (Month 24 assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients at all time points.||quotient of E/A||Standard Deviation|Mean
809845|NCT01047306|Post-Hoc|Change From Baseline in Tricuspid Valve Regurgitant Velocity|ECG allows a non-invasive assessment of cardiac structure, function, and hemodynamics and can provide essential insight into mechanisms of disease and therapeutic benefit. Backwards blood flow through the tricuspid valve is measured during one heartbeat. A negative value indicates decreased velocity.|Baseline, 6 months, 12 months, End of Study (Month 24 assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients at all time points.||meters/second||Standard Deviation|Mean
809909|NCT01047553|Primary|ECG Variables QTcF Interval|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.||milisecond||Standard Deviation|Mean
809846|NCT01047306|Post-Hoc|Percent of Participants With Trace Regurgitation as Assessed by ECG|ECG allows a non-invasive assessment of cardiac structure, function, and hemodynamics and can provide essential insight into mechanisms of disease and therapeutic benefit. Regurgitation indicates that blood flows backwards through the valve.|12 months|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.||percentage of participants|||Number
809847|NCT01047306|Post-Hoc|Percent of Participants With Thickened Heart Valves as Assessed by Echocardiography (ECG)|ECG allows a non-invasive assessment of cardiac structure, function, and hemodynamics and can provide essential insight into mechanisms of disease and therapeutic benefit.|12 months|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.||percentage of participants|||Number
809848|NCT01047306|Secondary|Percent of Participants With Profound Hearing Loss, as Assessed by the Auditory Brainstem Response (ABR)|Hearing loss in subjects with MPS IIIA was characterized by assessing the ABR. The ABR is a voltage response evoked by acoustic stimuli as sound is processed along the auditory pathway. It consists of electrical signals resulting from the sum of sound-evoked activity along the auditory nerve and brainstem nuclei. The ABR analysis determines the sound intensity at which a neural response first appears (hearing threshold). Other parameters of interest include amplitude (the number of neurons firing), latency (the speed of transmission), interpeak latency (the time between peaks), and interaural latency (the difference in wave V latency between ears). The interpeak latency I-V interval (or central transmission time) is considered the most reliable index of brainstem function. Auditory brainstem response assessments were conducted under anesthesia. Profound hearing loss: 91+ decibels hearing level (dBHL).|Baseline, 6 months, 12 months, End of Study (Month 24 assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients at all time points.||percentage of participants|||Number
809849|NCT01047306|Secondary|Number of Participants With Mild, Moderate, or Severe Hearing Loss at End of Study, as Assessed by The Auditory Brain Response (ABR)|Hearing loss in subjects with MPS IIIA was characterized by assessing the ABR. The ABR is a voltage response evoked by acoustic stimuli as sound is processed along the auditory pathway. It consists of electrical signals resulting from the sum of sound-evoked activity along the auditory nerve and brainstem nuclei. The ABR analysis determines the sound intensity at which a neural response first appears (hearing threshold). Other parameters of interest include amplitude (the number of neurons firing), latency (the speed of transmission), interpeak latency (the time between peaks), and interaural latency (the difference in wave V latency between ears). The interpeak latency I-V interval (or central transmission time) is considered the most reliable index of brainstem function. Auditory brainstem response assessments were conducted under anesthesia. Mild hearing loss: 21-40 decibels hearing level (dBHL), moderate hearing loss: 41-70 dBHL, severe hearing loss: 71-90 dBHL.|End of Study (12 months assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.||participants|||Number
809850|NCT01047306|Secondary|Number of Participants With Mild, Moderate, or Severe Hearing Loss at 12 Months, as Assessed by The Auditory Brain Response (ABR)|Hearing loss in subjects with MPS IIIA was characterized by assessing the ABR. The ABR is a voltage response evoked by acoustic stimuli as sound is processed along the auditory pathway. It consists of electrical signals resulting from the sum of sound-evoked activity along the auditory nerve and brainstem nuclei. The ABR analysis determines the sound intensity at which a neural response first appears (hearing threshold). Other parameters of interest include amplitude (the number of neurons firing), latency (the speed of transmission), interpeak latency (the time between peaks), and interaural latency (the difference in wave V latency between ears). The interpeak latency I-V interval (or central transmission time) is considered the most reliable index of brainstem function. Auditory brainstem response assessments were conducted under anesthesia. Mild hearing loss: 21-40 decibels hearing level (dBHL), moderate hearing loss: 41-70 dBHL, severe hearing loss: 71-90 dBHL.|12 months|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.||participants|||Number
809851|NCT01047306|Secondary|Number of Participants With Mild, Moderate, or Severe Hearing Loss at 6 Months, as Assessed by The Auditory Brain Response (ABR)|Hearing loss in subjects with MPS IIIA was characterized by assessing the ABR. The ABR is a voltage response evoked by acoustic stimuli as sound is processed along the auditory pathway. It consists of electrical signals resulting from the sum of sound-evoked activity along the auditory nerve and brainstem nuclei. The ABR analysis determines the sound intensity at which a neural response first appears (hearing threshold). Other parameters of interest include amplitude (the number of neurons firing), latency (the speed of transmission), interpeak latency (the time between peaks), and interaural latency (the difference in wave V latency between ears). The interpeak latency I-V interval (or central transmission time) is considered the most reliable index of brainstem function. Auditory brainstem response assessments were conducted under anesthesia. Mild hearing loss: 21-40 decibels hearing level (dBHL), moderate hearing loss: 41-70 dBHL, severe hearing loss: 71-90 dBHL.|6 months|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.||participants|||Number
809852|NCT01047306|Secondary|Number of Participants With Mild, Moderate, or Severe Hearing Loss at Baseline, as Assessed by The Auditory Brain Response (ABR)|Hearing loss in subjects with MPS IIIA was characterized by assessing the ABR. The ABR is a voltage response evoked by acoustic stimuli as sound is processed along the auditory pathway. It consists of electrical signals resulting from the sum of sound-evoked activity along the auditory nerve and brainstem nuclei. The ABR analysis determines the sound intensity at which a neural response first appears (hearing threshold). Other parameters of interest include amplitude (the number of neurons firing), latency (the speed of transmission), interpeak latency (the time between peaks), and interaural latency (the difference in wave V latency between ears). The interpeak latency I-V interval (or central transmission time) is considered the most reliable index of brainstem function. Auditory brainstem response assessments were conducted under anesthesia. Mild hearing loss: 21-40 decibels hearing level (dBHL), moderate hearing loss: 41-70 dBHL, severe hearing loss: 71-90 dBHL.|Baseline|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.||participants|||Number
810724|NCT01048606|Primary|Glucose Metabolism: 2h-75g Oral Glucose Tolerance Test (OGTT) + Plasma Insulin and Glucose Concentrations (Blood Sample Analysis).||6 months||||||
809853|NCT01047306|Secondary|Percent of Participants With Conductive Hearing Loss at End of Study, as Assessed by the Auditory Brainstem Response (ABR)|Conductive hearing loss occurs when there is a problem conducting sound waves along the route through the outer ear, tympanic membrane, or middle ear. Hearing loss in subjects with MPS IIIA was characterized by assessing the ABR. The ABR is a voltage response evoked by acoustic stimuli as sound is processed along the auditory pathway. It consists of electrical signals resulting from the sum of sound­evoked activity along the auditory nerve and brainstem nuclei. The ABR analysis determines the sound intensity at which a neural response first appears (hearing threshold). Other parameters of interest include amplitude (number of neurons firing), latency (speed of transmission), interpeak latency (time between peaks), and interaural latency (difference in wave V latency between ears). The interpeak latency I­V interval (or central transmission time) is considered the most reliable index of brainstem function. Auditory brainstem response assessments were conducted under anesthesia.|End of Study (12 months assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.||percentage of participants|||Number
809854|NCT01047306|Secondary|Percent of Participants With Conductive Hearing Loss at 12 Months, as Assessed by the Auditory Brainstem Response (ABR)|Conductive hearing loss occurs when there is a problem conducting sound waves along the route through the outer ear, tympanic membrane, or middle ear. Hearing loss in subjects with MPS IIIA was characterized by assessing the ABR. The ABR is a voltage response evoked by acoustic stimuli as sound is processed along the auditory pathway. It consists of electrical signals resulting from the sum of sound­evoked activity along the auditory nerve and brainstem nuclei. The ABR analysis determines the sound intensity at which a neural response first appears (hearing threshold). Other parameters of interest include amplitude (number of neurons firing), latency (speed of transmission), interpeak latency (time between peaks), and interaural latency (difference in wave V latency between ears). The interpeak latency I­V interval (or central transmission time) is considered the most reliable index of brainstem function. Auditory brainstem response assessments were conducted under anesthesia.|12 months|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.||percentage of participants|||Number
809855|NCT01047306|Secondary|Percent of Participants With Conductive Hearing Loss at 6 Months, as Assessed by the Auditory Brainstem Response (ABR)|Conductive hearing loss occurs when there is a problem conducting sound waves along the route through the outer ear, tympanic membrane, or middle ear. Hearing loss in subjects with MPS IIIA was characterized by assessing the ABR. The ABR is a voltage response evoked by acoustic stimuli as sound is processed along the auditory pathway. It consists of electrical signals resulting from the sum of sound­evoked activity along the auditory nerve and brainstem nuclei. The ABR analysis determines the sound intensity at which a neural response first appears (hearing threshold). Other parameters of interest include amplitude (number of neurons firing), latency (speed of transmission), interpeak latency (time between peaks), and interaural latency (difference in wave V latency between ears). The interpeak latency I­V interval (or central transmission time) is considered the most reliable index of brainstem function. Auditory brainstem response assessments were conducted under anesthesia.|6 months|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.||percentage of participants|||Number
809856|NCT01047306|Secondary|Percent of Participants With Conductive Hearing Loss at Baseline, as Assessed by the Auditory Brainstem Response (ABR)|Conductive hearing loss occurs when there is a problem conducting sound waves along the route through the outer ear, tympanic membrane, or middle ear. Hearing loss in subjects with MPS IIIA was characterized by assessing the ABR. The ABR is a voltage response evoked by acoustic stimuli as sound is processed along the auditory pathway. It consists of electrical signals resulting from the sum of sound­evoked activity along the auditory nerve and brainstem nuclei. The ABR analysis determines the sound intensity at which a neural response first appears (hearing threshold). Other parameters of interest include amplitude (number of neurons firing), latency (speed of transmission), interpeak latency (time between peaks), and interaural latency (difference in wave V latency between ears). The interpeak latency I­V interval (or central transmission time) is considered the most reliable index of brainstem function. Auditory brainstem response assessments were conducted under anesthesia.|Baseline|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.||percentage of participants|||Number
809857|NCT01047306|Secondary|Percent of Participants With Sensorineural Hearing Loss at End of Study, as Assessed by the Auditory Brainstem Response (ABR)|Sensorineural hearing loss occurs from damage to the inner ear, the brain, or the nerve that runs from the ear to the brain (auditory nerve). Hearing loss in subjects with MPS IIIA was characterized by assessing the ABR. The ABR is a voltage response evoked by acoustic stimuli as sound is processed along the auditory pathway. It consists of electrical signals resulting from the sum of sound­evoked activity along the auditory nerve and brainstem nuclei. The ABR analysis determines the sound intensity at which a neural response first appears (hearing threshold). Other parameters of interest include amplitude (the number of neurons firing), latency (the speed of transmission), interpeak latency (the time between peaks), and interaural latency (the difference in wave V latency between ears). The interpeak latency I­V interval (or central transmission time) is considered the most reliable index of brainstem function. Auditory brainstem response assessments were conducted under anesthesia.|End of Study (12 months assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.||percentage of participants|||Number
809881|NCT01047345|Primary|Percentage of Participants Who Experience a Systemic AE – Base Study|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Systemic AEs were those not categorized as injection-site AEs.|up to 14 days after any vaccination - Base Study|All participants who received at least 1 vaccination and had available follow-up data.||Percentage of Participants|||Number
809910|NCT01047553|Primary|ECG Variables - QTcB Interval|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.||milisecond||Standard Deviation|Mean
809858|NCT01047306|Secondary|Percent of Participants With Sensorineural Hearing Loss at 12 Months, as Assessed by the Auditory Brainstem Response (ABR)|Sensorineural hearing loss occurs from damage to the inner ear, the brain, or the nerve that runs from the ear to the brain (auditory nerve). Hearing loss in subjects with MPS IIIA was characterized by assessing the ABR. The ABR is a voltage response evoked by acoustic stimuli as sound is processed along the auditory pathway. It consists of electrical signals resulting from the sum of sound­evoked activity along the auditory nerve and brainstem nuclei. The ABR analysis determines the sound intensity at which a neural response first appears (hearing threshold). Other parameters of interest include amplitude (the number of neurons firing), latency (the speed of transmission), interpeak latency (the time between peaks), and interaural latency (the difference in wave V latency between ears). The interpeak latency I­V interval (or central transmission time) is considered the most reliable index of brainstem function. Auditory brainstem response assessments were conducted under anesthesia.|12 months|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.||percentage of participants|||Number
809859|NCT01047306|Secondary|Percent of Participants With Sensorineural Hearing Loss at 6 Months, as Assessed by the Auditory Brainstem Response (ABR)|Sensorineural hearing loss occurs from damage to the inner ear, the brain, or the nerve that runs from the ear to the brain (auditory nerve). Hearing loss in subjects with MPS IIIA was characterized by assessing the ABR. The ABR is a voltage response evoked by acoustic stimuli as sound is processed along the auditory pathway. It consists of electrical signals resulting from the sum of sound­evoked activity along the auditory nerve and brainstem nuclei. The ABR analysis determines the sound intensity at which a neural response first appears (hearing threshold). Other parameters of interest include amplitude (the number of neurons firing), latency (the speed of transmission), interpeak latency (the time between peaks), and interaural latency (the difference in wave V latency between ears). The interpeak latency I­V interval (or central transmission time) is considered the most reliable index of brainstem function. Auditory brainstem response assessments were conducted under anesthesia.|6 months|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.||percentage of participants|||Number
809860|NCT01047306|Secondary|Percent of Participants With Sensorineural Hearing Loss at Baseline, as Assessed by the Auditory Brainstem Response (ABR)|Sensorineural hearing loss occurs from damage to the inner ear, the brain, or the nerve that runs from the ear to the brain (auditory nerve). Hearing loss in subjects with MPS IIIA was characterized by assessing the ABR. The ABR is a voltage response evoked by acoustic stimuli as sound is processed along the auditory pathway. It consists of electrical signals resulting from the sum of sound­evoked activity along the auditory nerve and brainstem nuclei. The ABR analysis determines the sound intensity at which a neural response first appears (hearing threshold). Other parameters of interest include amplitude (the number of neurons firing), latency (the speed of transmission), interpeak latency (the time between peaks), and interaural latency (the difference in wave V latency between ears). The interpeak latency I­V interval (or central transmission time) is considered the most reliable index of brainstem function. Auditory brainstem response assessments were conducted under anesthesia.|Baseline|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.||percentage of participants|||Number
809861|NCT01047306|Secondary|Percent of Participants With an Abnormal Overall Test Result of Auditory Brainstem Response (ABR) at End of Study|Hearing loss in subjects with MPS IIIA was characterized by assessing the ABR. The ABR is a voltage response evoked by acoustic stimuli as sound is processed along the auditory pathway. It consists of electrical signals resulting from the sum of sound-evoked activity along the auditory nerve and brainstem nuclei. The ABR analysis determines the sound intensity at which a neural response first appears (hearing threshold). Other parameters of interest include amplitude (the number of neurons firing), latency (the speed of transmission), interpeak latency (the time between peaks), and interaural latency (the difference in wave V latency between ears). The interpeak latency I-V interval (or central transmission time) is considered the most reliable index of brainstem function. Auditory brainstem response assessments were conducted under anesthesia. An abnormal value was greater than 21 decibels hearing level (dBHL).|End of Study (12 months assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.||percentage of participants|||Number
809862|NCT01047306|Secondary|Percent of Participants With an Abnormal Overall Test Result of Auditory Brainstem Response (ABR) at 12 Months|Hearing loss in subjects with MPS IIIA was characterized by assessing the ABR. The ABR is a voltage response evoked by acoustic stimuli as sound is processed along the auditory pathway. It consists of electrical signals resulting from the sum of sound-evoked activity along the auditory nerve and brainstem nuclei. The ABR analysis determines the sound intensity at which a neural response first appears (hearing threshold). Other parameters of interest include amplitude (the number of neurons firing), latency (the speed of transmission), interpeak latency (the time between peaks), and interaural latency (the difference in wave V latency between ears). The interpeak latency I-V interval (or central transmission time) is considered the most reliable index of brainstem function. Auditory brainstem response assessments were conducted under anesthesia. An abnormal value was greater than 21 decibels hearing level (dBHL).|12 months|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.||percentage of participants|||Number
809863|NCT01047306|Secondary|Percent of Participants With an Abnormal Overall Test Result of Auditory Brainstem Response (ABR) at 6 Months|Hearing loss in subjects with MPS IIIA was characterized by assessing the ABR. The ABR is a voltage response evoked by acoustic stimuli as sound is processed along the auditory pathway. It consists of electrical signals resulting from the sum of sound-evoked activity along the auditory nerve and brainstem nuclei. The ABR analysis determines the sound intensity at which a neural response first appears (hearing threshold). Other parameters of interest include amplitude (the number of neurons firing), latency (the speed of transmission), interpeak latency (the time between peaks), and interaural latency (the difference in wave V latency between ears). The interpeak latency I-V interval (or central transmission time) is considered the most reliable index of brainstem function. Auditory brainstem response assessments were conducted under anesthesia. An abnormal value was greater than 21 decibels hearing level (dBHL).|6 months|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.||percentage of participants|||Number
809864|NCT01047306|Secondary|Percent of Participants With an Abnormal Overall Test Result of Auditory Brainstem Response (ABR) at Baseline|Hearing loss in subjects with MPS IIIA was characterized by assessing the ABR. The ABR is a voltage response evoked by acoustic stimuli as sound is processed along the auditory pathway. It consists of electrical signals resulting from the sum of sound-evoked activity along the auditory nerve and brainstem nuclei. The ABR analysis determines the sound intensity at which a neural response first appears (hearing threshold). Other parameters of interest include amplitude (the number of neurons firing), latency (the speed of transmission), interpeak latency (the time between peaks), and interaural latency (the difference in wave V latency between ears). The interpeak latency I-V interval (or central transmission time) is considered the most reliable index of brainstem function. Auditory brainstem response assessments were conducted under anesthesia. An abnormal value was greater than 21 decibels hearing level (dBHL).|Baseline|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.||percentage of participants|||Number
809865|NCT01047306|Secondary|Change From Baseline in The Total Disability Score (TDS) of The Four Point Scoring System (FPSS)|The FPSS is an MPS III-specific disability assessment that evaluates motor function, expressive language, and cognitive function on a 0- to 3- point scale and can be used for individuals of all ages. A score of 3 points is assigned for normal function, 2 points for beginning of regression, 1 point for severe level of regression, and 0 points for lost skills. The total disability score (TDS) is the average of the motor function, speech, and cognitive function scores (range: 0, 3). The scoring is based on the parent’s response to a detailed questionnaire that covers several aspects of the disease. A positive value indicates improvement in function.|Baseline, 6 months, 12 months, and End of Study (Month 24 assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients at all time points.||units on a scale||Standard Deviation|Mean
809866|NCT01047306|Secondary|Change From Baseline Values in Gray Matter Volume Assessed by Brain Magnetic Resonance Imaging (MRI)|Total brain cortical gray matter volume was determined by analysis of brain MRI. The analysis was performed using “Freesurfer” software, which provides completely automated parcellation of the brain cortex and subcortical structures. In some cases, manual adjustments were necessary in cases of intensity normalization failure, resulting in erroneous white matter segmentation. A negative value indicates that gray matter volume decreased.|Baseline, 6 months, 12 months, and End of Study (Month 24 assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients at all time points.||milliliters||Standard Deviation|Mean
809867|NCT01047306|Other Pre-specified|Change From Baseline in Urine Glycosaminoglycan (GAG) Levels|Urine GAG was measured by a dye binding assay. A negative value indicates that GAG levels decreased.|Baseline, 6 months, 12 months, and End of Study (Month 24 assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients at all time points.||mg GAG/mmol creatinine||Standard Deviation|Mean
809868|NCT01047306|Primary|Change From Baseline in VABS-II Overall DQ Scores|The VABS-II test measures adaptive behaviors, including the ability to cope with environmental changes, to learn new everyday skills, and to demonstrate independence. It is an instrument that supports the diagnosis of intellectual and developmental disabilities in patients from birth to 90 years. This test measures the following 5 key domains: communication, daily living skills, socialization, motor skills, and the adaptive behavior composite (a composite of the other 4 domains). The DQ is a means to express a neurodevelopmental/cognitive delay. The DQ was computed as a ratio and expressed as a percentage using the age-equivalent score divided by the age at testing ([age-equivalent score/chronological age] × 100; range, 0, 100). The overall DQ score is calculated from the mean age-equivalent score obtained by averaging out the age-equivalent scores for the all the sub-domains except for Gross and Fine motor skills. A positive value indicates improvement in health and cognition.|Baseline, 6 months, 12 months, and End of Study (Month 24 assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients at all time points.||percentage of chronological age||Standard Deviation|Mean
809869|NCT01047306|Primary|Change From Baseline in Vineland Adaptive Behavior Scales-II (VABS-II) Age-equivalent Scores|The VABS-II test measures adaptive behaviors, including the ability to cope with environmental changes, to learn new everyday skills, and to demonstrate independence. It is an instrument that supports the diagnosis of intellectual and developmental disabilities in patients from birth to 90 years. This test measures the following 5 key domains: communication, daily living skills, socialization, motor skills, and the adaptive behavior composite (a composite of the other 4 domains). The mean age-equivalent score is obtained by averaging out the age-equivalent scores for the all the sub-domains except for Gross and Fine motor skills (range: 0, unbound). A positive value indicates improvement in health and cognition|Baseline, 6 months, 12 months, and End of Study (Month 24 assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients at all time points.||months||Standard Deviation|Mean
809870|NCT01047306|Primary|Change From Baseline in BSID-III/KABC-II Developmental Quotient (DQ) Scores|The determination of whether a patient received BSID­III was based on an algorithm that includes the patient's calendar age and VABS­II age ­equivalent score (See Outcome 1). The BSID­III is a series of measurements to assess the motor (fine and gross), language (receptive and expressive), and cognitive development of infants and toddlers and consists of a series of developmental play tasks. The KABC­II is an individually administered measure of processing and reasoning abilities. The DQ is a means to express a neurodevelopmental/cognitive delay. The DQ was computed as a ratio and expressed as a percentage using the age-equivalent score divided by the age at testing ([age-equivalent score/chronological age] × 100; range: 0, 100). The BSID­III DQ score is based on the cognitive domain. The DQ score for KABC­II is calculated from the average non­verbal age-equivalent score. A positive value indicates improvement in health and cognition.|Baseline, 6 months, 12 months, and End of Study (Month 24 assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients at all time points.||percentage of chronological age||Standard Deviation|Mean
810521|NCT01052480|Secondary|Days on Supplemental Oxygen|Time (in days) of supplemental oxygen use|Measured from Day 0 through Day 28|The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza.||days||Inter-Quartile Range|Median
809871|NCT01047306|Primary|Change From Baseline in Bayley Scales of Infant Development-III/Kaufman Assessment Battery for Children-II (BSID-III/KABC-II) Age-Equivalent Scores|Children 1 year-42 months were assessed by the BSID­III; those >42 months and with a developmental age of >42 months by the Vineland Adaptive Behavior Scales­II (VABS­II) were evaluated with the KABC­II. For children >42 months, but <42 months in developmental age, and those unable to complete at least 3 cognitive KABC­II subtests, the BSID­III was used. The BSID­III is a series of measurements to assess the motor, language, and cognitive development of infants and toddlers and consists of a series of developmental play tasks. The KABC­II is an individually administered measure of processing/reasoning abilities. Raw scores were converted to age­ equivalent scores to measure ability, skill, and knowledge, expressed as the age at which most individuals reach the same level (age norm; range: 0, unbound ). A positive value indicates improvement. The BSID­III and KABC­II age­ equivalent scores were based on the cognitive domain and average non-verbal age-equivalent score, respectively.|Baseline, 6 months, 12 months, and End of Study (Month 24 assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients at all time points.||months||Standard Deviation|Mean
809872|NCT01047332|Secondary|Number of Participants With Recurrent Biliary Obstruction Reported by Mechanism|Mechanisms of recurrent biliary obstructions are defined as tumor ingrowth, tumor overgrowth, stent migration, sludge, food debris, stent failed to expand and unknown. Stents may be obstructed by more than one mechanism, therefore, the total does not add up to the number of stent obstructions in each group.|Median follow-up of 125 days in the uncovered SEMS arm and 201 days in the partially covered SEMS arm|All randomized participants.||participants|||Number
809873|NCT01047332|Secondary|Number of Participants With Serious Adverse Events (SAEs)|Serious adverse events were defined as adverse events requiring an invasive procedure or hospitalization or resulting in death.|From time of stent placement to participant death or lost to follow-up (up to 1302 days)|All randomized participants.||Participants|||Count of Participants
809874|NCT01047332|Secondary|Patient Survival|Patient survival is defined as the date of the placement of the stent to the date of death. Participants lost to follow-up were analyzed in an intention-to-treat fashion and censored at the time of their last follow-up interview.|Median follow-up of 125 days in the uncovered SEMS arm and 201 days in the partially covered SEMS arm|All randomized participants.||days||Inter-Quartile Range|Median
809875|NCT01047332|Primary|Time to Recurrent Biliary Obstruction|Biliary obstruction is the narrowing (stricture) of the bile duct. This narrowing prevents bile, which is formed in the liver, from being carried to the small bowel to digest fats. Symptoms of biliary obstruction are pain, jaundice (yellow skin and eyes), itchy skin and fever. Time to biliary obstruction is defined as the time from the placement of the stent to the time of biliary obstruction as reported by the participant via monthly interview questions or call to a pager if symptoms of recurrent biliary obstruction developed. Participants not experiencing recurrent biliary obstruction were censored at the date of last follow-up or date of death.|Median follow-up of 125 days in the uncovered SEMS arm and 201 days in the partially covered SEMS arm|All randomized participants.||days||Inter-Quartile Range|Median
809876|NCT01047345|Other Pre-specified|Percentage of Participants Who Experience an SAE- Extension Study|An SAE is one that results in death, disability/incapacity, or hospitalization or is life threatening, a congenital anomaly or birth defect, cancer, an overdose, or otherwise jeopardizes the participant and may require medical intervention.|up to Month 7 - Extension Study|All participants who received at least 1 vaccination in Extension Study and had available follow-up data.||Percentage of Participants|||Number
809877|NCT01047345|Secondary|Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine - Base Study|Serum antibody titers for HPV virus-like particles (VLPs), Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using competitive luminex immunoassay (cLIA). The serostatus cutoffs (milli Merck U/mL) for HPV types were as follows: HPV Type 6: ≥30, HPV Type 11: ≥16; HPV Type 16: ≥20, HPV Type 18: ≥24, HPV Type 31: ≥10, HPV Type 33: ≥8, HPV Type 45: ≥8, HPV Type 52: ≥8, and HPV Type 58: ≥8.|4 weeks post-vaccination 3 (Month 7; End of Base Study)|Participants who received all 3 vaccinations within an acceptable day range, had Month 7 serology sample collected within an acceptable range and had no other protocol violations that could interfere with immunes response to the vaccine. Statistical testing performed only within the 9vHPV arm and only for HPV types 31, 33, 45, 52, and 58.||Percentage of Participants||95% Confidence Interval|Number
809878|NCT01047345|Primary|Percentage of Participants Who Experience a Severe Injection-site AE – Base Study|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Participants were instructed to estimate the severity of AEs such as pain at injection site as mild (awareness of symptom, but easily tolerated), moderate (discomfort enough to cause interference with usual activities), or severe (incapacitating with inability to work or do usual activity). Additionally, participants were instructed to measure any swelling and/or erythema at its greatest width. Swelling or erythema with diameter >2 inches (>5 cm) was recorded as severe. All AEs associated with the injection site and reported as severe were summarized.|up to 5 days after any vaccination - Base Study|All participants who received at least 1 vaccination and had available follow-up data.||Percentage of Participants|||Number
809879|NCT01047345|Primary|Percentage of Participants Who Experience a Vaccine-related SAE Any Time During Study– Base Study|An SAE is one that results in death, disability/incapacity, or hospitalization or is life threatening, a congenital anomaly or birth defect, cancer, an overdose, or otherwise jeopardizes the participant and may require medical intervention. An SAE that is judged by the Investigator to be “definitely related,” “probably related,” or “possibly related” is defined as a vaccine-related SAE.|Up to 7 months - Base Study|All participants who received at least 1 vaccination and had available follow-up data.||Percentage of Participants|||Number
809880|NCT01047345|Primary|Percentage of Participants Who Experience a Serious Adverse Event (SAE) Within 15 Days of Any Vaccination – Base Study|An SAE is one that results in death, disability/incapacity, or hospitalization or is life threatening, a congenital anomaly or birth defect, cancer, an overdose, or otherwise jeopardizes the participant and may require medical intervention.|up to 14 days after any vaccination - Base Study|All participants who received at least 1 vaccination and had available follow-up data.||Percentage of Participants|||Number
809882|NCT01047345|Primary|Percentage of Participants With Body Temperature ≥100.0°F (≥37.8ºC) – Base Study|Participants collected their oral body temperature in the evening of their vaccination day and at the same time each day thereafter for 4 days. The maximum body temperature obtained within 5 days of any of the 3 vaccinations was recorded.|up to 5 days after any vaccination - Base Study|All participants who received at least 1 vaccination and had available temperature data.||Percentage of Participants|||Number
809883|NCT01047345|Primary|Percentage of Participants Who Experience an Injection-site Adverse Event (AE) – Base Study|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. The percentage of participants who reported an AE that was associated with the injection site such as redness, swelling, and pain/tenderness/soreness was summarized.|up to 5 days after any vaccination - Base Study|All participants who received at least 1 vaccination and had available follow-up data.||Percentage of Participants|||Number
809884|NCT01047358|Secondary|Percentage of Participants by Overall Tumor Response Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST) (Advanced Breast Cancer)|The antitumor efficacy for advanced breast cancer was measured by objective tumor assessments according to the RECIST of uni-dimensional evaluation. Complete response (CR) was defined as disappearance of all target and non-target lesions, and no new lesions. Partial response (PR) was defined as disappearance of all target lesions, a persistence of ≥1 non-target lesions, no new lesions; or a ≥30% decrease in the sum of the longest dimensions of the target lesions, no unequivocal progression of existing non-target lesions, no new lesions. Stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), no unequivocal progression of existing non-target lesions, and no new lesions. PD was defined as a ≥20% increase in the sum of the longest dimensions of the target lesions; or unequivocal progression of existing non-target lesions, or the appearance of ≥1 new lesions.|At the end of the study, average of 5.6 months|Efficacy Analysis Set.||Percentage of Participants|||Number
809885|NCT01047358|Secondary|Time-to-Progression (Early Breast Cancer)|Time-to-Progression was defined as the duration from the date of first administration of Aromasin to the date of recurrence or contralateral breast cancer.|At the end of the study, average of 5.6 months|This outcome was planned to be analyzed in participants with early breast cancer in the efficacy analysis set. However, the analysis was not performed because the data of time-to-progression was not captured in the CRF.|||||
809886|NCT01047358|Secondary|Percentage of Participants Without Recurrence/Metastasis (Early Breast Cancer)|The antitumor efficacy for early breast cancer was measured by recurrence/metastasis status (Yes or No) of the participant at the end of the study. The investigator recorded the final evaluation date and the information of tumor recurrence or metastasis (Yes or No) in each participant’s case report form (CRF).|At the end of the study, average of 5.6 months.|Efficacy Analysis Set: included all participants who received Aromasin for at least 4 weeks in treatment of breast cancer and had efficacy data available.||Percentage of Participants|||Number
809887|NCT01047358|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)|All AEs reported after start of administration of Aromasin were considered as TEAEs and summarized.|From the first dose of Aromasin through the end of the study for an average of 5.6 months|Safety Analysis Set: included participants who received Aromasin at least once and were evaluated upon its related safety endpoints at least once.||Percentage of Participants|||Number
809888|NCT01047436|Secondary|Parasite Reduction Ratio (PRR) at 12 Hours After the First Dose|Reduction in parasitaemia from baseline at 12 hours after the first dose of study medication|12 h (hours) after first dose|For the efficacy endpoints, the analysis was based on the Full Analysis Set (FAS) which was defined as all patients that received at least 1 dose of trial medication and had at least 1 post dose parasite count at 12 h or 24 h||Percent reduction||Full Range|Median
809889|NCT01047436|Primary|Time for Parasite Count to Fall by 50% PCT(50)|The time taken for the parasite count to fall 50% from baseline|3 h (hours) , 6h, 12h, 18h, 24h, 30h, 36h, 48h, 54h, 60h|||hours||Standard Deviation|Mean
809890|NCT01047436|Secondary|Parasite Reduction Ratio (PRR) at 24 h (Hours) After the First Dose|Reduction in parasitaemia from baseline at 24 h after the first dose of study medication|24 hours after first dose|For the efficacy endpoints, the analysis was based on the Full Analysis Set (FAS) which was defined as all patients that received at least 1 dose of trial medication and had at least 1 post dose parasite count at 12 h or 24 h||Percent reduction||Full Range|Median
809891|NCT01047436|Primary|Time for Parasite Count to Fall by 90% PCT(90)|The time taken for the parasite count to fall 90% from baseline|3h (hours), 6h, 12h, 18h, 24h, 30h, 36h, 48h, 54h, 60h|||hours||Standard Deviation|Mean
809892|NCT01047436|Secondary|Parasite Clearance Time|Time in hours from the initiation of therapy until the first of two successive parasite-negative smears were obtained|3h (hours), 6h, 12h, 18h, 24h, 30h, 36h, 48h, 54h, 60h|||Hours||Standard Deviation|Mean
809893|NCT01047436|Primary|Parasitological Success Defined as a Reduction in Parasite Count of ≥ 90% of Baseline at 24 Hours After the First Dose||24 hours after first dose|For the efficacy endpoints, the analysis was based on the Full Analysis Set (FAS) which was defined as all patients that received at least 1 dose of trial medication and had at least 1 post dose parasite count at 12 h (hours) or 24 h after start of treatment.||participants|||Number
809894|NCT01047475|Primary|The Primary Efficacy Endpoint of This Study is the Best Overall Response (Complete Response + Partial Response)|The primary efficacy analysis, the incidence of best overall response during the study period, was based on the Fisher’s exact test for the binary response that was used to test for the differences in the treatment efficacy between MB-6 and Placebo.|16 weeks|||percentage of Best overall Response||95% Confidence Interval|Median
809895|NCT01047527|Primary|Week 24 Point Prevalence Abstinence|self-reported abstinence from smoking for 7 days prior to the assessment and biochemically confirmed with breath carbon monoxide|24-week|This analysis was planned to replicate the previous study (Schnoll et al., 2010; Annals of Internal Medicine).||participants|||Number
809896|NCT01047527|Primary|Point Prevalence Abstinence|self-reported abstinence from smoking for 7 days prior to the assessment and biochemically confirmed with breath carbon monoxide|52-week|The primary objective of this study was to examine the benefits in terms of cessation of 52-weeks of treatment compared to 8 or 24 weeks.||participants|||Number
809897|NCT01047553|Secondary|St George’s Respiratory Questionnaire (SGRQ) Total Score|SGRQ total score shows the impact of COPD on patient's health status, and expressed as a percentage of impairment with scale from 0 (best health status) to 100 (worst possible status). A negative rate of decline shows decreasing SGRQ total score (or improved health) over time, while a positive value shows increasing score (or worsen health). The change from Run-in period average to Treatment period average for each treatment group|Daily during run-in period (14 - 18 days before Randomisation visit ) and daily during 52-week randomization treatment|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any efficacy data after randomisation were available were included in the efficacy population (Full Analysis Set: FAS).||units on a scale||Standard Deviation|Mean
809898|NCT01047553|Secondary|Use of SABA (Salbutamol) as Reliever Medication|The change from Run-in period average to Treatment period average for each treatment group.|Daily during run-in period (14 - 18 days before Randomisation visit ) and daily during 52-week randomization treatment|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any efficacy data after randomisation were available were included in the efficacy population (Full Analysis Set: FAS).||Times/Day||Standard Deviation|Mean
809899|NCT01047553|Secondary|Number of COPD Exacerbations Over the Treatment Period|A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as worsening in COPD symptoms requiring treatment with either a course of systemic steroid or hospitalisation. Number of COPD exacerbation during 52-week randomization treatment was presented here.|Daily during 52-week randomization treatment|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any efficacy data after randomisation were available were included in the efficacy population (Full Analysis Set: FAS).||number of exacerbations|||Number
809900|NCT01047553|Secondary|Total Chronic Obstructive Pulmonary Disease (COPD) Symptom Score|The Total COPD Symptom score is the sum of the measures night-time awakening, breathlessness and cough, ranges from 0 to 12 with 12 being the most severe. The change from Run-in period average to Treatment period average for each treatment group.|Daily during run-in period (14 - 18 days before Randomisation visit ) and daily during 52-week randomization treatment|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any efficacy data after randomisation were available were included in the efficacy population (Full Analysis Set: FAS).||units on a scale||Standard Deviation|Mean
809901|NCT01047553|Secondary|Daytime Cough Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms|There are 5 alternatives (scored 0 to 4, with 4 being the most severe condition). The change from Run-in period average to Treatment period average for each treatment group|Daily during run-in period (14 - 18 days before Randomisation visit) and daily during 52-week randomization treatment|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any efficacy data after randomisation were available were included in the efficacy population (Full Analysis Set: FAS).||units on a scale||Standard Deviation|Mean
809902|NCT01047553|Secondary|Daytime Breathlessness Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms|There are 5 alternatives (scored 0 to 4, with 4 being the most severe condition). The change from Run-in period average to Treatment period average for each treatment group|Daily during run-in period (14 - 18 days before Randomisation visit ) and daily during 52-week randomization treatment|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any efficacy data after randomisation were available were included in the efficacy population (Full Analysis Set: FAS).||units on a scale||Standard Deviation|Mean
809903|NCT01047553|Secondary|Night-time Awakening Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms|There are 5 alternatives (scored 0 to 4, with 4 being the most severe condition). The change from Run-in period average to Treatment period average for each treatment group|Daily during run-in period (14 - 18 days before Randomisation visit ) and daily during 52-week randomization treatment|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any efficacy data after randomisation were available were included in the efficacy population (Full Analysis Set: FAS).||units on a scale||Standard Deviation|Median
809904|NCT01047553|Secondary|Evening Peak Expiratory Flow (PEF)|The change from Run-in period average to Treatment period average for each treatment group|Daily during run-in period (14 - 18 days before Randomisation visit) and daily during 52-week randomization treatment|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any efficacy data after randomisation were available were included in the efficacy population (Full Analysis Set: FAS).||Liter/minute (L/min)||Standard Deviation|Mean
809905|NCT01047553|Secondary|Morning Peak Expiratory Flow(PEF)|The change from Run-in period average to Treatment period average for each treatment group|Daily during run-in period (14 - 18 days before Randomisation visit)and daily during 52-week randomization treatment|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any efficacy data after randomisation were available were included in the efficacy population (Full Analysis Set: FAS).||Liter/minute (L/min)||Standard Deviation|Mean
809906|NCT01047553|Secondary|Forced Vital Capacity (FVC)|The ratio of the average value of available data for Weeks 0, 4, 8, 17, 26, 34, 43 and 52 to the baseline for each treatment group|Before randomization, 0, 4, 8, 17, 26, 34, 43 and 52 weeks after randomization|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any efficacy data after randomisation were available were included in the efficacy population (Full Analysis Set: FAS).||Percentage of baseline||Full Range|Geometric Mean
809907|NCT01047553|Secondary|Forced Expiratory Volume in One Second (FEV1)|The ratio of the average value of available data for mean from Weeks 0, 4, 8, 17, 26, 34, 43 and 52 to the baseline for each treatment group|Before randomization, 0, 4, 8, 17, 26, 34, 43 and 52 weeks after randomization|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any efficacy data after randomisation were available were included in the efficacy population (Full Analysis Set: FAS).||percentage of baseline||Full Range|Geometric Mean
809911|NCT01047553|Primary|ECG Variables - QT Interval|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.||milisecond||Standard Deviation|Mean
809912|NCT01047553|Primary|ECG Variables - Heart Rate|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.||beats/min||Standard Deviation|Mean
809913|NCT01047553|Primary|Vital Signs - Pulse Rate|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.||beats/minute||Standard Deviation|Mean
809914|NCT01047553|Primary|Vital Signs- Sitting DBP|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.||mmHg||Standard Deviation|Mean
809915|NCT01047553|Primary|Vital Signs- Sitting SBP|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.||mmHg||Standard Deviation|Mean
809916|NCT01047553|Primary|Clinical Laboratory Test: Clinical Chemistry - S-Blood Urea Nitrogen (BUN)|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.||mg/dl||Standard Deviation|Mean
809917|NCT01047553|Primary|Clinical Laboratory Test: Clinical Chemistry-S-Total Protein|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.||g/dl||Standard Deviation|Mean
809918|NCT01047553|Primary|Clinical Laboratory Test: Clinical Chemistry-S-Albumin|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.||g/dl||Standard Deviation|Mean
809919|NCT01047553|Primary|Clinical Laboratory Test: Clinical Chemistry-S- Calcium|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.||mg/dl||Standard Deviation|Mean
809920|NCT01047553|Primary|Clinical Laboratory Test: Clinical Chemistry-S-Potassium|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.||mEq/L||Standard Deviation|Mean
809921|NCT01047553|Primary|Clinical Laboratory Test: Clinical Chemistry-S-Sodium|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.||mEq/l||Standard Deviation|Mean
809922|NCT01047553|Primary|Clinical Laboratory Test: Clinical Chemistry-S-Total Bilirubin|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.||mg/dL||Standard Deviation|Mean
809923|NCT01047553|Primary|Clinical Laboratory Test: Clinical Chemistry-S-Creatinine|Change from Baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.||mg/dL||Standard Deviation|Mean
809924|NCT01047553|Primary|Clinical Laboratory Test: Clinical Chemistry-S-Alkaline Phosphatase (ALP)|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.||U/l||Standard Deviation|Mean
809925|NCT01047553|Primary|Clinical Laboratory Test: Clinical Chemistry-S-Aspartate Aminotransferase|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.||U/l||Standard Deviation|Mean
809926|NCT01047553|Primary|Clinical Laboratory Test: Clinical Chemistry- S-Alanine Aminotransferase|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.||U/l||Standard Deviation|Mean
809927|NCT01047553|Primary|Clinical Laboratory Test: Haematology -Neutrophils|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.||percentage of Neutrophil||Standard Deviation|Mean
809928|NCT01047553|Primary|Clinical Laboratory Test: Haematology-Monocytes|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.||percentage of Monocyte||Standard Deviation|Mean
809929|NCT01047553|Primary|Clinical Laboratory Test: Haematology-Lymphocytes|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.||percentage of Lymphocyte||Standard Deviation|Mean
809930|NCT01047553|Primary|Clinical Laboratory Test: Haematology Basophil|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.||percentage of Basophil||Standard Deviation|Mean
809931|NCT01047553|Primary|Clinical Laboratory Test: Haematology Eosinophils|Change from baseline|baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.||percentage of Eosinophil||Standard Deviation|Mean
809932|NCT01047553|Primary|Clinical Laboratory Test: Haematology-Platelet Count|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.||Platelet Count x10000/μl||Standard Deviation|Mean
809933|NCT01047553|Primary|Clinical Laboratory Test: Haematology-Leucocytes|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.||leukocyte count/µL||Standard Deviation|Mean
809934|NCT01047553|Primary|Clinical Laboratory Test: Haematology -Haemoglobin|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.||g/dL||Standard Deviation|Mean
809935|NCT01047553|Primary|Clinical Laboratory Test: Haematology -Erythrocytes|Mean change from Baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.||erythrocytes counts x10000/μl||Standard Deviation|Mean
809936|NCT01047709|Primary|Apnea-hypopnea Index|Apnea-hypopnea index (AHI) is the sum of the apneas and hypopneas and divided by the hours of presumed sleep. AHI values are typically categorized as 5-15/hr = mild; 15-30/hr = moderate; and >= 30/h = severe. The relative treatment effect on AHI using GEE modeling.|1 day|||events/hr||Inter-Quartile Range|Median
809937|NCT01047839|Secondary|SCRs and GMTs at Day 56 and Month 7 Stratified According to Dose Groups and Age Groups||at Day 56 and Month 7||||||
809938|NCT01047839|Secondary|GMTs for JEV Neutralizing Antibodies Measured Using a Validated PRNT at Day 56 and Month 7||at Day 56 and Month 7||||||
809939|NCT01047839|Secondary|SCRs as Defined as Percentage of Subjects With JEV Neutralizing Antibody Titers of PRNT 50 >= 1:10 at Day 56 and Month 7, Measured Using a Validated Plaque Reduction Neutralization Test (PRNT)||at Day 56 and Month 7||||||
809940|NCT01047839|Secondary|Rate of Subjects With Abnormal Laboratory Parameters up to Day 56 and up to Month 7 After the First Vaccination||up to Day 56 and up to Month 7||||||
809941|NCT01047839|Secondary|Rate of Subjects With Unsolicited AEs up to Day 56 and up to Month 7 After the First Vaccination||up to Day 56 and upt to Month 7||||||
809942|NCT01047839|Secondary|Rate of Subjects With Solicited Local and Systemic aEs Assessed With a Subject Diary for 7 Consecutive Days After Each Vaccination||7 days||||||
809943|NCT01047839|Secondary|Rate of Subjects With Serious Adverse Events (SAEs) and Medically Attended AEs up to Month 7 After the First Vaccination||up to Month 7||||||
809944|NCT01047839|Primary|Rate of Subjects With Serious Adverse Events (SAEs) and Medically Attended AEs up to Day 56 After the First Vaccination|Rate of subjects with serious adverse events (SAEs) and medically attended AEs up to Day 56 after the first vaccination.|until Day 56|||percentage of participants||95% Confidence Interval|Number
809945|NCT01040689|Secondary|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG|Clinical relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsenings of baseline conditions were reported as Adverse Events related to treatment (cardiac disorders and investigations).|6 weeks|Treated set.||percentage of participants|||Number
809946|NCT01040689|Secondary|Trough FVC Response|Response was defined as change from baseline. Study baseline trough FVC was defined as the mean of the available pre-dose trough FVC values prior to first dose in first treatment period. Trough values were mean of the values obtained 23 h and 23 h 50 min after the last dose of study drug after six weeks of treatment. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Study baseline and 6 weeks|FAS including all patients with evaluable data after six weeks.||Liter||Standard Error|Mean
809947|NCT01040689|Secondary|Peak FVC (0-3h) Response|Response was defined as change from baseline. Study baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose in first treatment period. Peak FVC (0-3h) was obtained within 0 - 3 hours after the last dose of study drug after 6 weeks of treatment. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Study baseline and 6 weeks|FAS including all patients with evaluable data after six weeks.||Liter||Standard Error|Mean
809948|NCT01040689|Secondary|FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose in the first treatment period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of the first treatment period (study baseline) and -30 min, 30 min, 60 min, 2 h, 3 h relative to last dose after six weeks of treatment.|FAS including all patients with evaluable data after six weeks.||Liter||Standard Error|Mean
809993|NCT01040793|Secondary|Adjusted Mean Total Lung Capacity 1 Hour Post-dose After 6 Weeks|Measured using body plethysmography|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.||liters||Standard Error|Least Squares Mean
809949|NCT01040689|Secondary|FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose in the first treatment period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of the treatment period (study baseline) and -30 min, 30 min, 60 min, 2 h, 3 h relative to first dose of treatment|FAS including all patients with evaluable data after first dose of treatment.||Liter||Standard Error|Mean
809950|NCT01040689|Secondary|FVC Area Under Curve 0-24 Hours (AUC 0-24h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to first dose in first treatment period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FVC AUC 0-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of the first treatment period (study baseline) and -30 min, 30 min, 60 min, 2 h, 3 h, 4 h, 6h, 8h, 10h, 12 h, 22 h, 23 h, and 23 h 50 min relative to last dose after six weeks of treatment.|FAS including all patients with evaluable data after six weeks.||Liter||Standard Error|Mean
809951|NCT01040689|Secondary|FVC Area Under Curve 12-24 Hours (AUC 12-24h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to first dose of first treatment period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FVC AUC 12-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 h and 10 min prior to dose on the first day of the first treatment period (study baseline) and 12 h, 22 h, 23 h, and 23 h 50 min relative to last dose after six weeks of treatment|FAS including all patients with evaluable data after six weeks.||Liter||Standard Error|Mean
809952|NCT01040689|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-12 Hours (AUC 0-12h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to first dose in first treatment period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FVC AUC 0-12h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of the first treatment period (study baseline) and -30 min (zero time), 30 min, 60 min, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12h relative to last dose after six weeks of treatment.|FAS including all patients with evaluable data after six weeks.||Liter||Standard Error|Mean
809953|NCT01040689|Secondary|Trough FEV1 Response|Response was defined as change from baseline. Study baseline trough FEV1 was defined as the mean of the available pre-dose trough FEV1 values prior to first dose of first treatment period. Trough values were the mean of values obtained 23 hours and 23h 50min post the last dose of study drug after six weeks of treatment . Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Study baseline and 6 weeks|FAS including all patients with evaluable data after six weeks.||Liter||Standard Error|Mean
809954|NCT01040689|Secondary|Peak FEV1 (0-3h) Response|Response was defined as change from baseline. Study baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of first treatment period. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after the last dose after six weeks of treatment. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Study baseline and 6 weeks|FAS including all patients with evaluable data after six weeks.||Liter||Standard Error|Mean
809955|NCT01040689|Secondary|Peak FEV1 (0-3h) Response|Response was defined as change from baseline. Study baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of first treatment period. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after the first dose of treatment. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Study baseline and first day of dosing|FAS including all patients with evaluable data after first dose of treatment.||Liter||Standard Error|Mean
809956|NCT01040689|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response After Six Weeks of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of the first treatment period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FEV1 AUC 0-3h was calculated from 0-3hours post-dose using the trapezoidal rule, divided by the observation time (3 h) to report in litres.|1 hour (h) prior and 10 minutes (min) prior to first dose of the first treatment period (study baseline) and -30 min, 30 min, 60 min, 2 h , 3 h, relative to the last dose of treatment after six weeks of treatment.|FAS including all patients with evaluable data after six weeks.||Liter||Standard Error|Mean
809957|NCT01040689|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response After First Dose of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of the first treatment period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FEV1 AUC 0-3h was calculated from 0-3hours post-dose using the trapezoidal rule, divided by the observation time (3 h) to report in litres.|1 hour (h) prior and 10 minutes (min) prior to first dose of the first period (study baseline) and -30 min, 30 min, 60 min, 2 h , 3 h, relative to the first dose of treatment period|FAS including all patients with evaluable data after first dose of treatment.||Liter||Standard Error|Mean
809994|NCT01040793|Secondary|Adjusted Mean Total Lung Capacity 30 Minutes Pre-dose After 6 Weeks|Measured using body plethysmography|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.||liters||Standard Error|Least Squares Mean
809958|NCT01040689|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-24 h (AUC 0-24h) Response After Six Weeks of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the first visit of the first treatment period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FEV1 AUC 0-24h was calculated from 0-24 hours post-dose using the trapezoidal rule, divided by the observation time (24h) to report in litres.|1 hour (h) and 10 minutes (min) prior to am dose on the first day of the first treatment period (study baseline) and -30 min, 30 min, 60 min, 2 h, 3 h, 4 h, 6h, 8h, 10h, 12 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment|FAS including all patients with evaluable data after six weeks.||Liter||Standard Error|Mean
809959|NCT01040689|Primary|FEV1 Area Under Curve 12-24h (AUC 12-24h) Response After Six Weeks of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed in the morning of the first treatment visit for the first period, just prior to administration of the morning dose of randomized treatment. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FEV1 AUC 12-24h was calculated from 12-24 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 h and 10 min prior to am dose on the first day of the first treatment period (study baseline) and 12 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment|FAS including all patients with evaluable data after six weeks.||Liter||Standard Error|Mean
809960|NCT01040689|Primary|FEV1 Area Under Curve 0-12 h (AUC 0-12h) Response After Six Weeks of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed in the morning of the first treatment visit for the first period, just prior to administration of the morning dose of randomized treatment. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FEV1 AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 hour (h) and 10 minutes (min) prior to am dose on the first day of the first treatment period (study baseline) and -30 min (zero time), 30 min, 60 min, 2 hour (h) , 3 h, 4 h, 6 h, 8 h, 10 h, 12 h relative to am dose after six weeks of treatment|Full analysis set (FAS). FAS is defined as all patients with baseline (pre-dose) data and any evaluable post-dosing data for either co-primary endpoint from the same treatment period. FAS including all patients with evaluable data after six weeks.||Liter||Standard Error|Mean
809961|NCT01040728|Secondary|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG|Clinical relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsenings of baseline conditions were reported as Adverse Events related to treatment (cardiac disorders and investigations).|6 weeks|Treated set.||participants|||Number
809962|NCT01040728|Secondary|Trough FVC Response|Response was defined as change from baseline. Study baseline trough FVC was defined as the mean of the available pre-dose trough FVC values prior to first dose of treatment for the first period. Trough values were the mean of obtained 23 h and 23 h 50 min after the last dose of study drug after six weeks of treatment . Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Study baseline and 6 weeks|FAS including all patients with evaluable data for this endpoint after six weeks.||Liter||Standard Error|Mean
809963|NCT01040728|Secondary|Peak FVC (0-3h) Response|Response was defined as change from baseline. Study baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of treatment for the first period. Peak FVC (0-3h) was obtained within 0 - 3 hours after the last am dose of study drug after 6 weeks of treatment. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Study baseline and 6 weeks|FAS including all patients with evaluable data for this endpoint after six weeks.||Liter||Standard Error|Mean
809964|NCT01040728|Secondary|FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of treatment for the first period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to the am dose on the first day of the first treatment period (study baseline) and -30 min, 30 min, 60 min, 2 h, 3 h relative to last dose of treatment after six weeks of treatment|FAS including all patients with evaluable data for this endpoint after six weeks.||Liter||Standard Error|Mean
809965|NCT01040728|Secondary|FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of treatment for the first period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to the am dose on the first day of the first treatment period (study baseline) and -30 min, 30 min, 60 min, 2 h, 3 h relative to first dose of treatment|FAS including all patients with evaluable data for this endpoint after first dose of treatment.||Liter||Standard Error|Mean
809966|NCT01040728|Secondary|FVC Area Under Curve 0-24 Hours (AUC 0-24h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to first dose of treatment for the first period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FVC AUC 0-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to am dose on the first day of the first treatment period (study baseline) and -30 min, 30 min, 60 min, 2 h, 3 h, 4 h, 6h, 8h, 10h, 12 h, 22 h, 23 h, and 23 h 50 min relative to last dose after six weeks of treatment|FAS including all patients with evaluable data for this endpoint after six weeks.||Liter||Standard Error|Mean
810725|NCT01048606|Primary|Plasma Lipid Profile: the Apolipoproteins (Apo-AI, Apo-AII, Apo-B), Cholesterol HDL, LDL and Triglycerides Levels Will be Determined by Clinical Analyses of Blood Sample (Obtained After 12 h Fasting State)||12 months||||||
809967|NCT01040728|Secondary|FVC Area Under Curve 12-24 Hours (AUC 12-24h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to first dose of treatment for the first period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FVC AUC 12-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 h and 10 min prior to the am dose on the first day of the first treatment period (study baseline) and 12 h, 22 h, 23 h, and 23 h 50 min relative to last dose after six weeks of treatment|FAS including all patients with evaluable data for this endpoint after six weeks.||Liter||Standard Error|Mean
809968|NCT01040728|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-12 Hours (AUC 0-12h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to first dose of treatment for the first period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FVC AUC 0-12h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to the am dose on the first day of the first treatment period (study baseline) and -30 min (zero time), 30 min, 60 min, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12h relative to last dose after six weeks of treatment.|FAS including all patients with evaluable data for this endpoint after six weeks.||Liter||Standard Error|Mean
809969|NCT01040728|Secondary|Trough FEV1 Response|Response was defined as change from baseline. Study baseline trough FEV1 was defined as the mean of the available pre-dose trough FEV1 values prior to first dose of treatment for the first period. Trough values were the mean of values obtained 23h and 23 h 50 min after the last dose of study drug after six weeks of treatment . Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Study baseline and 6 weeks|FAS including all patients with evaluable data for this endpoint after six weeks.||Liter||Standard Error|Mean
809970|NCT01040728|Secondary|Peak FEV1 (0-3h) Response|Response was defined as change from baseline. Study baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of treatment for the first period. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after the last dose after six weeks of treatment. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Study baseline and 6 weeks|FAS including all patients with evaluable data for this endpoint after six weeks.||Liter||Standard Error|Mean
809971|NCT01040728|Secondary|Peak FEV1 (0-3h) Response|Response was defined as change from baseline. Study baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of treatment for the first period. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after the first dose of treatment. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Study baseline and first day of dosing|FAS including all patients with evaluable data for this endpoint after first dose of treatment.||Liter||Standard Error|Mean
809972|NCT01040728|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response After Six Weeks of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of treatment for the first period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FEV1 AUC 0-3h was calculated from 0-3hours post-dose using the trapezoidal rule, divided by the observation time (3 h) to report in litres.|1 hour (h) prior and 10 minutes (min) prior to the am dose on the first day of the first treatment period (study baseline) and -30 min, 30 min, 60 min, 2 h , 3 h, relative to the first dose of treatment after six weeks of treatment|FAS including all patients with evaluable data for this endpoint after six weeks.||Liter||Standard Error|Mean
809973|NCT01040728|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response After First Dose of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of the treatment at the first treatment visit for the first period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FEV1 AUC 0-3h was calculated from 0-3hours post-dose using the trapezoidal rule, divided by the observation time (3 h) to report in litres.|1 hour (h) prior and 10 minutes (min) prior to the am dose on the first day of the first treatment period (study baseline) and -30 min, 30 min, 60 min, 2 h , 3 h, relative to the first dose of treatment period|FAS including all patients with evaluable data for this endpoint after first dose of treatment.||Liter||Standard Error|Mean
809974|NCT01040728|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-24 h (AUC 0-24h) Response After Six Weeks of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose at the first randomized treatment visit for the first period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FEV1 AUC 0-24h was calculated from 0-24 hours post-dose using the trapezoidal rule, divided by the observation time (24h) to report in litres.|1 hour (h) and 10 minutes (min) prior to am dose on the first day of the first treatment period (study baseline) and -30 min, 30 min, 60 min, 2 h, 3 h, 4 h, 6h, 8h, 10h, 12 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment|FAS including all patients with evaluable data for this endpoint after six weeks.||Liter||Standard Error|Mean
809975|NCT01040728|Primary|FEV1 Area Under Curve 12-24h (AUC 12-24h) Response After Six Weeks of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed in the morning of the first treatment visit for the first period, just prior to administration of the first morning dose of randomized treatment. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FEV1 AUC 12-24h was calculated from 12-24 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 h and 10 min prior to the am dose on the first day of the first treatment period (study baseline) and 12 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment|FAS including all patients with evaluable data for this endpoint after six weeks.||Liter||Standard Error|Mean
809976|NCT01040728|Primary|FEV1 Area Under Curve 0-12 h (AUC 0-12h) Response After Six Weeks of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed in the morning of the first treatment visit for the first period, just prior to administration of the first morning dose of randomized treatment. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FEV1 AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 hour (h) and 10 minutes (min) prior to the am dose on the first day of the first treatment period (study baseline) and -30 min (zero time), 30 min, 60 min, 2 hour (h) , 3 h, 4 h, 6 h, 8 h, 10 h, 12 h relative to am dose after six weeks of treatment|Full analysis set (FAS). FAS is defined as all patients with baseline (pre-dose) data and any evaluable post-dosing data for either of the co-primary endpoints. FAS including all patients with evaluable data for this endpoint after six weeks.||Liter||Standard Error|Mean
809977|NCT01040780|Secondary|Safety and Tolerability|"Adverse Events (AEs) and Serious AEs (SAEs) are presented regardless of causality for patients who received at least one dose of Icotinib or Gefitinib. Events were graded by the investigator using the NCI CTCAE Scale (version 3.0) which provides a grading scale for each AE term.
Grade 3 = Severe Grade 4 = Life-threatening or disabling"|Assessed over two years|||participants|||Number
809978|NCT01040780|Secondary|Time To Progression|Median time until disease progression. Disease progression defined as radiological and/or symptomatic disease progression.|2-7 months|||months||95% Confidence Interval|Median
809979|NCT01040780|Secondary|Best Tumor Response|Change in size of tumor: Complete Response (CR) = no measurable tumor; Partial Response (PR) = 30% decrease in size of measurable tumor; Stable Disease (SD) = measurable tumor size has not changed; Progressive Disease (PD) = measurable tumor larger than at baseline|While receiving study treatment; assessed every 21 days until progression|||percentage of patients|||Number
809980|NCT01040780|Secondary|Overall Survival|Median number of months from first study treatment until time of death|From first study treatment until time of death|||months||95% Confidence Interval|Median
809981|NCT01040780|Primary|Progression Free Survival|Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline.|2-7 months|All patients who received at least one dose of study drug with measurable disease at baseline.||months||95% Confidence Interval|Median
809982|NCT01040793|Secondary|Number of Patients With Notable Increase in QRS Intervals|Number of Patients with notable increase in QRS intervals. Notable QRS interval increase defined as >=10% increase and on-treatment QRS interval > 110 ms.|Baseline and Week 6|Treated set.||percentage of participants|||Number
809983|NCT01040793|Secondary|Number of Patients With Notable Increase in PR Intervals|Number of Patients with notable increase in PR intervals. Notable PR interval increase defined as >=25% increase and on-treatment PR interval > 200 ms.|Baseline and Week 6|Treated set.||percentage of participants|||Number
809984|NCT01040793|Secondary|Number of Patients With Notable Changes in Heart Rate|Number of Patients with notable changes in heart rate (HR). Notable HR increase defined as >=25% increase and on-treatment HR > 100 bpm; Notable HR decrease defined as >=25% decrease and on-treatment HR < 50 bpm.|Baseline and Week 6|Treated set.||percentage of participants|||Number
809985|NCT01040793|Secondary|Change From Baseline to Day 43 in Pulse Rate|Change from Baseline to Day 43 in Pulse rate with spirometry. Baseline is defined as mean of pre-treatment values at a given time point.|Baseline and Week 6|Treated set. Statistics only include patients with both a baseline and a post dose value.||beats/min||Standard Deviation|Mean
809986|NCT01040793|Secondary|Change From Baseline to Day 43 in Blood Pressure|Change from Baseline to Day 43 in Blood Pressure with spirometry. Baseline is defined as mean of pre-treatment values at a given time point.|Baseline and Week 6|Treated set. Statistics only include patients with both a baseline and a post dose value.||mmHg||Standard Deviation|Mean
809987|NCT01040793|Secondary|Adjusted Mean Peak Expiratory Flow Rate, 1 Hour Post-dose After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.||liters/second||Standard Error|Least Squares Mean
809988|NCT01040793|Secondary|Adjusted Mean Peak Expiratory Flow Rate, 30 Minutes Pre-dose After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.||liters/second||Standard Error|Least Squares Mean
809989|NCT01040793|Secondary|Adjusted Mean Forced Vital Capacity, 1 Hour Post-dose After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.||liters||Standard Error|Least Squares Mean
809990|NCT01040793|Secondary|Adjusted Mean Forced Vital Capacity, 30 Minutes Pre-dose After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.||liters||Standard Error|Least Squares Mean
809991|NCT01040793|Secondary|Adjusted Mean Forced Expiratory Volume in 1 Second, 1 Hour Post-dose After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.||liters||Standard Error|Least Squares Mean
809992|NCT01040793|Secondary|Adjusted Mean Forced Expiratory Volume in 1 Second, 30 Minutes Pre-dose After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.||liters||Standard Error|Least Squares Mean
810726|NCT01048606|Primary|Plasma Lipid Profile: the Apolipoproteins (Apo-AI, Apo-AII, Apo-B), Cholesterol HDL, LDL and Triglycerides Levels Will be Determined by Clinical Analyses of Blood Sample (Obtained After 12 h Fasting State)||6 months||||||
809995|NCT01040793|Secondary|Adjusted Mean Inspiratory Capacity 1 Hour Post-dose After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.||liters||Standard Error|Least Squares Mean
809996|NCT01040793|Secondary|Adjusted Mean Inspiratory Capacity 30 Minutes Pre-dose After 6 Weeks|Measured using body plethysmography|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.||liters||Standard Error|Least Squares Mean
809997|NCT01040793|Secondary|Adjusted Mean Functional Residual Capacity 1 Hour Post-dose After 6 Weeks|Measured using body plethysmography|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.||liters||Standard Error|Least Squares Mean
809998|NCT01040793|Secondary|Adjusted Mean Functional Residual Capacity 30 Minutes Pre-dose After 6 Weeks|Measured using body plethysmography|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.||liters||Standard Error|Least Squares Mean
809999|NCT01040793|Secondary|Adjusted Mean Borg Scale of Breathing Discomfort at End of Exercise After 6 Weeks|Borg scale rates discomfort with breathing at rest, during exercise and at end-exercise on a scale from 0=Nothing at all to 10=Maximal discomfort.|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint.||Scores on a scale||Standard Error|Least Squares Mean
810000|NCT01040793|Secondary|Adjusted Mean Borg Scale of Breathing Discomfort at Pre-exercise After 6 Weeks|Borg scale rates discomfort with breathing at rest, during exercise and at end-exercise on a scale from 0=Nothing at all to 10=Maximal discomfort.|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint.||Scores on a scale||Standard Error|Least Squares Mean
810001|NCT01040793|Secondary|Adjusted Mean Inspiratory Capacity at End of Exercise After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.||liters||Standard Error|Least Squares Mean
810002|NCT01040793|Secondary|Adjusted Mean Inspiratory Capacity at Pre-exercise After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.||liters||Standard Error|Least Squares Mean
810003|NCT01040793|Secondary|Adjusted Mean Borg Scale of Breathing Discomfort at Isotime After 6 Weeks|"Isotime is defined as the endurance time of the constant work rate exercise test of shortest duration from Baseline visit, and Week 6 of each of the three treatment periods.
Borg scale rates discomfort with breathing at rest, during exercise and at end-exercise on a scale from 0=Nothing at all to 10=Maximal discomfort."|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint.||Scores on a scale||Standard Error|Least Squares Mean
810004|NCT01040793|Secondary|Adjusted Mean Inspiratory Capacity at Isotime After 6 Weeks|Isotime is defined as the endurance time of the constant work rate exercise test of shortest duration from Baseline visit, and Week 6 of each of the three treatment periods.|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.||liters||Standard Error|Least Squares Mean
810005|NCT01040793|Primary|Adjusted Mean Endurance Time After 6 Weeks|Primary endpoint was endurance time during constant work rate ergometry to symptom limitation at 75% of maximal work capacity after 6 weeks of treatment. Mixed effects model on log10 transformation data. Adjusted means are back transformed to report as geometric means. Standard errors (SEs) are calculated using the delta method.|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint.||seconds||Standard Error|Geometric Mean
810006|NCT01040819|Primary|Plasma 15-epi-lipoxin A4|Plasma 15-epi-LXA4 levels|2 months|||ng/ml||Standard Error|Mean
810007|NCT01040832|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs|An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered. A Serious AE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.|Time from first dose up to Day 42 to 49 after last dose of trial treatment, reported between day of first participant randomized, that is, 17 Dec 2009 until cut-off date, (11 Jan 2012)|Safety population included all the participants who received at least 1 dose study drug.||participants|||Number
810008|NCT01040832|Secondary|Overall Survival (OS) Time|The overall survival (OS) time was defined as the time from randomization to death. Participants without event were censored at the last date known to be alive or at the clinical cut-off date, whatever was earlier.|Time from randomization to death or last day known to be alive, reported between day of first participant randomized, that is, 17 Dec 2009 until cut-off date, (11 Jan 2012)|ITT population included all the randomized participants who had received study treatment. Overall survival data was analyzed only for participants who received cetuximab plus EMD 1201081.||months||95% Confidence Interval|Median
810727|NCT01048606|Primary|Body Composition: Dual-energy X-ray Absorptiometry Method||12 months||||||
810009|NCT01040832|Secondary|Percentage of Participants With Disease Control: Independent Read Assessments|Percentage of participants with disease control, defined as having achieved CR or PR or stable disease (SD) as the tumor response according to radiological assessments (based on RECIST Version 1.0 criteria), was reported. As per RECIST v1.0 for target lesions and assessed by MRI: CR = disappearance of all target lesions; PR = at least 30% decrease in the sum of the longest diameter of target lesions; SD = neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.|Every 6 weeks until disease progression, reported between day of first participant randomized, that is, 17 Dec 2009 until cut-off date (11 Jan 2012)|ITT population included all the randomized participants who had received study treatment.||percentage of participants||95% Confidence Interval|Number
810010|NCT01040832|Secondary|Percentage of Participants With Objective Response: Independent Read Assessments|Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0) as assessed by Independent Read. As per RECIST v1.0 for target lesions and assessed by MRI: CR = Disappearance of all target lesions; PR = at least 30% decrease in the sum of the longest diameter of target lesions.|Every 6 weeks until disease progression, reported between day of first participant randomized, that is, 17 Dec 2009 until cut-off date (11 Jan 2012)|ITT population included all the randomized participants who had received study treatment.||percentage of participants||95% Confidence Interval|Number
810011|NCT01040832|Primary|Progression-free Survival (PFS) Time: Independent Read Assessments|The PFS time is defined as the duration from randomization to either first observation of progressive disease (PD) or occurrence of death due to any cause within 60 days of the last tumor assessment or randomization. Participants without event were censored on the date of last tumor assessment.|Every 6 weeks until disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, 17 Dec 2009 until cut-off date (11 Jan 2012)|ITT population included all the randomized participants who had received study treatment.||months||95% Confidence Interval|Median
810012|NCT01040845|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] for Colchicine With Norethindrone/Ethinyl Estradiol|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|Day 21 of each cycle - plasma concentrations were drawn prior to the morning dose (0 hour) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 (prior to pm colchicine/placebo dose), and 24 hours post-dose|||ng/mL||Standard Deviation|Mean
810013|NCT01040845|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] for Ethinyl Estradiol With Placebo|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|Day 21 of each cycle - plasma concentrations were drawn prior to the morning dose (0 hour) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 (prior to pm colchicine/placebo dose), and 24 hours post-dose.|||ng/mL||Standard Deviation|Mean
810014|NCT01040845|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] Ethinyl Estradiol With Colchicine|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.5, 5, 5.5, 6, 7, 8, 10, 14, 18, 24, 36, and 48 hours after drug administration.|||ng/mL||Standard Deviation|Mean
810015|NCT01040845|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] for Norethindrone With Placebo|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|Day 21 of each cycle - plasma concentrations were drawn prior to the morning dose (0 hour) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 (prior to pm colchicine/placebo dose), and 24 hours post-dose.|||ng/mL||Standard Deviation|Mean
810016|NCT01040845|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] for Norethindrone With Colchicine|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|Day 21 of each cycle - plasma concentrations were drawn prior to the morning dose (0 hour) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 (prior to pm colchicine/placebo dose), and 24 hours post-dose.|||ng-hr/mL||Standard Deviation|Mean
810017|NCT01040845|Primary|Maximum Plasma Concentration of Colchicine With Norethindrone/Ethinyl Estradiol at Steady State (Cmax, ss)|The maximum or peak concentration that Colchicine with Norethindrone/Ethinyl Estradiol reaches in the plasma at steady state. Steady state refers to the point that constant concentration of drug is achieved subsequent to administration of constant doses of that drug given at constant intervals|Day 21 of each cycle - plasma concentrations were drawn prior to the morning dose (0 hour) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 (prior to pm colchicine/placebo dose), and 24 hours post-dose|||ng/mL||Standard Deviation|Mean
810018|NCT01040845|Primary|Maximum Plasma Concentration of Ethinyl Estradiol With Placebo at Steady State (Cmax, ss)|The maximum or peak concentration that Ethinyl Estradiol with Placebo reaches in the plasma at steady state. Steady state refers to the point that constant concentration of drug is achieved subsequent to administration of constant doses of that drug given at constant intervals.|Day 21 of each cycle - plasma concentrations were drawn prior to the morning dose (0 hour) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 (prior to pm colchicine/placebo dose), and 24 hours post-dose.|||ng/mL||Standard Deviation|Mean
810019|NCT01040845|Primary|Maximum Plasma Concentration of Ethinyl Estradiol With Colchicine at Steady State (Cmax, ss)|The maximum or peak concentration that Ethinyl Estradiol with Colchicine reaches in the plasma at steady state. Steady state refers to the point that constant concentration of drug is achieved subsequent to administration of constant doses of that drug given at constant intervals.|Day 21 of each cycle - plasma concentrations were drawn prior to the morning dose (0 hour) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 (prior to pm colchicine/placebo dose), and 24 hours post-dose.|||ng/mL||Standard Deviation|Mean
810036|NCT01040871|Secondary|Progression-free Survival (PFS)Rate at 1-year|Kaplan-meier estimate of progression-free survival at 1-year. Progression-free survival was defined as the interval between the date of randomization and the date of first documented evidence of disease progression or death.|1 year|Intent to Treat Population||percentage of partipants||95% Confidence Interval|Number
810728|NCT01048606|Primary|Body Composition: Dual-energy X-ray Absorptiometry Method||6 months||||||
810020|NCT01040845|Primary|Maximum Plasma Concentration of Norethindrone With Placebo at Steady State (Cmax, ss)|The maximum or peak concentration that Norethindrone with Placebo reaches in the plasma at steady state. Steady state refers to the point that constant concentration of drug is achieved subsequent to administration of constant doses of that drug given at constant intervals.|Day 21 of each cycle - plasma concentrations were drawn prior to the morning dose (0 hour) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 (prior to pm colchicine/placebo dose), and 24 hours post-dose.|||ng/mL||Standard Deviation|Mean
810021|NCT01040845|Primary|Maximum Plasma Concentration of Norethindrone With Colchicine at Steady State (Cmax, ss)|The maximum or peak concentration that Norethindrone with Colchicine reaches in the plasma at steady state. Steady state refers to the point that constant concentration of drug is achieved subsequent to administration of constant doses of that drug given at constant intervals.|Day 21 of each cycle - plasma concentrations were drawn prior to the morning dose (0 hour) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 (prior to pm colchicine/placebo dose), and 24 hours post-dose.|||ng/mL||Standard Deviation|Mean
810022|NCT01040858|Secondary|Satisfaction With Life Scale|A brief measure of global life satisfaction. It measures the sum of satisfaction ratings for 5 items on a scale from 1 (strongly disagree) to 7 (strongly agree). The total score ranges from 5 to 35 with higher scores indicating greater satifaction.|Week 10|The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.||units on a scale||Standard Deviation|Mean
810023|NCT01040858|Secondary|Severity of Dependence Scale|A brief substance dependence measure. It measures the sum of severity ratings for 5 symptoms on a scale from 0 (never) to 3 (always). The total score ranges from 0 15.|Week 10|The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.||units on a scale||Standard Deviation|Mean
810024|NCT01040858|Secondary|Beck Depression Inventory, Second Edition|A depression symptom severity measures based on DSM-IV diagnostic criteria. It measures the sum of severity ratings for 21 symptoms on a scale from 0 (none) to 3 (severe). BDI total score ranges from 0 to 63.|Week 10|The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.||units on a scale||Standard Deviation|Mean
810025|NCT01040858|Secondary|PTSD Checklist-Military Version|A PTSD symptom severity measures based on DSM-IV diagnostic criteria. It measures the sum of severit ratings for 17 symptoms on a scale from 1 (not at all) to 5 (extremely). PCL-M total score ranges from 17 to 85.|Week 10|The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.||units on a scale||Standard Deviation|Mean
810026|NCT01040858|Secondary|Delis-Kaplan Executive Function System, Verbal Fluency Subtest|A measure of verbal fluency, generativity, and processing speed. A scaled score of Letter Fluency portion of the test was used. The scores ranged from 0 to 20 with higher scores indicating better outcomes.|Week 10|The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.||units on a scale||Standard Deviation|Mean
810027|NCT01040858|Secondary|Delis-Kaplan Executive Function System, Trails Subtest|A visual-motor task used to measure flexibility in thinking (executive function) and processing speed. Scaled score for Condition 4 was used, and possible scores ranges from 0 to 20 with higher scores indicating better outcome.|Week 10|The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.||units on a scale||Standard Deviation|Mean
810028|NCT01040858|Secondary|Wechsler Adult Intelligence Scale-3rd Edition, Digit Span Subtest|A measure of attention and working memory. Total score was used, and it ranges from 0 to 48, with higher scores indicating greater attentional capacity.|Week 10|The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.||units on a scale||Standard Deviation|Mean
810029|NCT01040858|Secondary|Hopkins Verbal Memory Test-Revised|Verbal list learning and delayed recall. Total recall T-score was used for the analyses. Total recall T-score ranges from 13 (severely impaired) to 86 (very superior).|Week 10|The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.||units on a scale||Standard Deviation|Mean
810030|NCT01040858|Secondary|Memory Compensation Questionnaire|The MCQ is a 44-item self-report questionnaire that rates the extent to which patients use various strategies to improve memory performance relevant to daily living. The MCQ measures the sum of memory strategies used on a scale from 0 (never) to 4 (always). The total score ranges from 0 to 176.|Week 10|The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.||units on a scale||Standard Deviation|Mean
810031|NCT01040858|Secondary|The Neurobehavioral Symptom Inventory|A post-concussive symptom measure. The total score on the measure is the sum of severity ratings for 22 symptoms on a scale from 0 (none) to 4 (very severe). NSI total score ranges from 0 to 88.|Week 10|The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.||units on a scale||Standard Deviation|Mean
810032|NCT01040858|Secondary|Prospective-Retrospective Memory Questionnaire (PRMQ; Crawford, Henry, Ward, &|A 16-item self-report severity measure of prospective and retrospective memory problems relevant to everyday life. The measure reports the sum of severity ratings on a scale from 1 (never) to 5 (very often). The PRMQ total score ranges from 16 to 80.|Week 10|The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.||units on a scale||Standard Deviation|Mean
810033|NCT01040858|Primary|Multiple Sclerosis Neuropsychological Screening Questionnaire-Patient Version|A self-report measure of severity of attention and organizational problems. It measures the sum of severity ratings on a scale from 0 (never) to 4 (very often). The total score ranges from 0 to 64.|Week 10|The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.||units on a scale||Standard Deviation|Mean
810034|NCT01040871|Secondary|Change in Fatigue and Patient Utility Scores||18-24 months||||||
810035|NCT01040871|Secondary|Overall Survival Rate at 1-year|Kaplan-meier estimate of overall survival at 1-year measured from date of randomization.|1 year|Intent to Treat Population||percentage of partipants||95% Confidence Interval|Number
810075|NCT01041417|Secondary|Change in Walking Speed Score on Walking Impairment Questionnaire (WIQ) From Baseline to 3 Months|The WIQ quantifies walking difficulty on a 100-point scale, in which 0 indicates extreme difficulty and 100 indicates no difficulty with walking speed.|Baseline, 3 months|||units on a scale||95% Confidence Interval|Mean
810037|NCT01040871|Secondary|Subsequent Anti-lymphoma Therapy Rate at 1-year|Kaplan-meier estimate of subsequent anti-lymphoma therapy at 1-year. Time to subsequent anti-lymphoma therapy was measured from the date of randomization to the start date of new treatment. Death due to disease progression prior to subsequent therapy was considered as an event. Otherwise, time to next anti-lymphoma treatment was censored at the date of death or the last date known to be alive.|1 year|Intent to Treat Population||percentage of participants||95% Confidence Interval|Number
810038|NCT01040871|Secondary|Rate of Durable Complete Response|Proportion of subjects who achieved a CR with duration of at least 6 months|Median follow up approx 12 months|||percentage of participants||95% Confidence Interval|Number
810039|NCT01040871|Secondary|Rate of Durable Response|Proportion of subjects who achieved a CR or PR with duration of at least 6 months. Duration of response (CR or PR) was calculated from the date of initial documentation of a response to the date of first documented evidence of disease progression or death due to disease progression. Response was evaluated by an Independent Radiology Review Committee using available computed tomography (CT) and positron emission tomography (PET) scans collected at Baseline, end of cycle 3, end of cycle 6 (or end of treatment) based on the Revised Response Criteria for Malignant Lymphoma.|Median follow up approx. 12 months|||percentage of participants||95% Confidence Interval|Number
810040|NCT01040871|Secondary|Overall Response Rate|"Overall response = Complete Response (CR) + Partial Response (PR) Response was evaluated by an Independent Radiology Review Committee using available computed tomography (CT) and positron emission tomography (PET) scans collected at Baseline, end of cycle 3, and end of cycle 6 (or end of treatment) based on the Revised Response Criteria for Malignant Lymphoma.
Complete Response: see primary endpoint Partial Response: At least a 50% decrease in the sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses."|6 cycles|All randomized subjects with non-GCB DLBCL who received at least 1 dose of any study drug, had at least 1 measurable lesion at baseline, and had at least 1 post-baseline response assessment||percentage of participants||90% Confidence Interval|Number
810041|NCT01040871|Primary|Complete Response (CR) Rate|"Complete response was evaluated by an Independent Radiology Review Committee using available computed tomography (CT) and positron emission tomography (PET) scans collected at Baseline, end of cycle 3, and end of cycle 6 (or end of treatment) based on the Revised Response Criteria for Malignant Lymphoma.
Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy.
PET scan was negative.
The spleen and/or liver, if enlarged before therapy on the basis of physical examination or CT scan, was not palpable on physical examination and was considered normal size by imaging studies; all splenic and hepatic nodules related to lymphomas disappeared.
If bone marrow was involved before treatment, the infiltrate cleared on repeated bone marrow biopsy.
No new sites of disease were detected."|6 cycles|All randomized subjects with non-GCB DLBCL who received at least 1 dose of any study drug, had at least 1 measurable lesion at baseline, and had at least 1 post-baseline response assessment||percentage of participants||90% Confidence Interval|Number
810042|NCT01041209|Secondary|Treatment Failure in Each Group|"Treatment failure was defined as: Persistence of fever after 2 days, or tachypnea or diminishing in respiratory rate less than 5 bpm after 2 days, or signs of severe pneumonia or requiring or changing antibiotics at any time.
Proportion of patients with treatment failure was compared between both groups (BPS vs Guideline)."|1, 2, 5, 7 and 10 days from baseline|||participants|||Number
810043|NCT01041209|Primary|Use of Antibiotics in Each Group|The proportion of patients receiving antibiotics was compared between both groups (BPS vs Guidelines).|At baseline|||participants|||Number
810044|NCT01041287|Primary|Pulse Wave Velocity (Measure of Arterial Stiffness)|The pulse wave velocity (PWV) system measured the velocity of the blood pressure waveform between the carotid and femoral arteries using a single-lead electrocardiogram and tonometer to measure the pressure pulse waveform sequentially at the two peripheral artery sites. PWV is calculated as PWV=distance (d)/time (t) and the unit of measure is reported as meters per second (m/s).|6 months|||meters per second (m/s)||Standard Deviation|Mean
810045|NCT01041287|Primary|Pulse Wave Velocity (Measure of Arterial Stiffness)|The pulse wave velocity (PWV) system measured the velocity of the blood pressure waveform between the carotid and femoral arteries using a single-lead electrocardiogram and tonometer to measure the pressure pulse waveform sequentially at the two peripheral artery sites. PWV is calculated as PWV=distance (d)/time (t) and the unit of measure is reported as meters per second (m/s).|3 months|||meters per second (m/s)||Standard Deviation|Mean
810046|NCT01041287|Primary|Pulse Wave Velocity (Measure of Arterial Stiffness)|The pulse wave velocity (PWV) system measured the velocity of the blood pressure waveform between the carotid and femoral arteries using a single-lead electrocardiogram and tonometer to measure the pressure pulse waveform sequentially at the two peripheral artery sites. PWV is calculated as PWV=distance (d)/time (t) and the unit of measure is reported as meters per second (m/s).|Baseline|||meters per second (m/s)||Standard Deviation|Mean
810047|NCT01041404|Secondary|Trastuzumab Maximum Serum Concentration (Cmax)|Median Cmax (measured as mg/L) calculated for all treated participants using the nominal dosage schedule administered as an IV infusion.|Predose and end of infusion on Days 1, 8, 15, and 64, and predose on Days 22 and 106|PK Population||mg/L||90% Confidence Interval|Median
810048|NCT01041404|Secondary|Trastuzumab Minimum Serum Concentration (Cmin)|Median Cmin (measured as milligrams per liter [mg/L]) calculated for all treated participants using the nominal dosage schedule administered as an IV infusion.|Predose and end of infusion on Days 1, 8, 15, and 64, and predose on Days 22 and 106|PK Population||mg/L||90% Confidence Interval|Median
810049|NCT01041404|Secondary|Steady State Trastuzumab Area Under the Concentration (AUC)|Individual steady state predicted exposure, as assessed by median AUC (measured as mg multiplied by [*] day per liter [L]) calculated for all treated participants using the nominal dosage schedule administered as an IV infusion. Individual steady state AUC was calculated using all available PK samples from all timepoints.|Predose and end of infusion on Days 1, 8, 15, and 64, and predose on Days 22 and 106|Pharmacokinetic (PK) population: all participants with at least 1 measurement of trastuzumab serum concentration associated with a documented trastuzumab dosing history.||mg*day/L||90% Confidence Interval|Median
810076|NCT01041417|Secondary|Change in Walking Distance Scores on Walking Impairment Questionnaire (WIQ) From Baseline to 6 Months|The WIQ quantifies walking difficulty on a 100-point scale, in which 0 indicates extreme difficulty and 100 indicates no difficulty with walking distance.|Baseline, 6 months|||units on a scale||95% Confidence Interval|Mean
810729|NCT01048606|Primary|Plasma Fibrinogen Levels Measured With Luminescence.||Baseline||||||
810050|NCT01041404|Secondary|Percentage of Participants With Change From Baseline in Body Weight by Percentage Change in Weight|Change in body weight was categorized as an increase of greater than (>)5 percent (%), no change (plus or minus [±]5%), decrease of >5-10%, or a decrease of >10% from BL to the end of study. Time windows were applied in order to assign visits to weight measurements, and the lowest post-screening value recorded was used for the analysis. The percentage change in weight from screening was summarized over time.|BL, Days 1, 22, 43, 64, 85, 106, 127, and every 21 days until disease progression of the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis|FAS. 273 and 283 participants were analyzed in the Fluoropyrimidine, Cisplatin and Trastuzumab, Fluoropyrimidine, Cisplatin groups, respectively.||percentage of participants|||Number
810051|NCT01041404|Secondary|Body Weight (Kilograms [kg]) at BL||BL|FAS||kg||Full Range|Median
810052|NCT01041404|Secondary|Percentage of Participants With a Change in Analgesic Medication During the Study|Analgesic medications were recorded throughout the study until disease progression.|BL, Days 1, 22, 43, 64, 85, 106, 127, and every 21 days until disease progression of the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis|FAS||percentage of participants|||Number
810053|NCT01041404|Secondary|Pain Intensity Scores as Assessed By Visual Analog Scale (VAS)|The participant assessed their pain on a 0 to 100 millimeter (mm) horizontal VAS. The left-hand extreme of the line equals 0 mm, and is described as “no pain” and the right-hand extreme equals 100 mm as “unbearable pain”. A negative change indicated improvement.|BL, Days 1, 22, 43, 64, 85, 106, 127, and every 21 days until disease progression of the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis|FAS; n = number of participants assessed for a specific parameter at a given visit.||mm||Standard Error|Mean
810054|NCT01041404|Secondary|EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores|The QLQ-STO22 is a gastric cancer quality of life questionnaire. There are 22 questions concerning disease, treatment related symptoms, side effects, dysphagia, nutritional aspects, and questions about the emotional problems of gastric cancer (dysphagia, pain, reflux, eating restrictions, anxiety, dry mouth, body image, and hair loss). The questions are grouped into five scales and 4 single items which are related to the symptoms of the disease. Most questions used 4-point scale (1 'Not at all' to 4 'Very much'; 1 question was a yes or no answer). A linear transformation was used to standardize all scores and single-items to a scale of 0 to 100; higher score=better level of functioning or greater degree of symptoms.|BL, Days 1, 22, 43, 64, 85, 106, 127, and every 21 days until disease progression of the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis|FAS; n = number of participants assessed for a specific parameter at a given visit.||scores on a scale||Standard Error|Mean
810055|NCT01041404|Secondary|European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score equals (=) better level of functioning or greater degree of symptoms.|BL, Days 1, 22, 43, 64, 85, 106, 127, and every 21 days until disease progression of the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis|FAS; n (number) = number of participants assessed for a specific parameter at a given visit.||scores on a scale||Standard Error|Mean
810056|NCT01041404|Primary|Overall Survival - Time to Event|The median time, in months, from the date of randomization to the date of an OS event. Participants were censored at the last date tumor measurement, the last date in the study drug log, or the date of last follow-up.|BL, Days 1, 8, 15, 22, 43, 64, 85, 106, 127, and every 21 days until the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis|FAS||months||95% Confidence Interval|Median
810057|NCT01041404|Secondary|Percentage of Participants With Clinical Benefit|Clinical benefit was defined as stable disease (SD), CR, or PR for 6 weeks or longer as determined by RECIST. For TLs, SD was defined as neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for PD, taking as a reference the smallest SLD recorded since treatment had started. For NTLs, SD was defined as a persistence of one or more NTLs and/or maintenance of tumor marker levels above the normal limits.|BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis|FAS||percentage of participants||95% Confidence Interval|Number
810058|NCT01041404|Secondary|Duration of Response|The median time, in months, of the duration of response. Participants were censored at the date of death, the date of last tumor measurement, the last date in study drug log, or the date of last follow-up.|BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis|FAS; only participants with a CR or PR were included in the analysis.||months||95% Confidence Interval|Median
810059|NCT01041404|Secondary|Duration of Response - Percentage of Participants With an Event|Duration of response was defined for responders as the time from the date on which the CR or PR was first recorded to the date on which PD is first noted. Participants were censored on the date of death, the date of last tumor measurement, the last date in study drug log, or the date of last follow-up.|BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis|FAS; only participants with a CR or PR were included in the analysis.||percentage of participants|||Number
810060|NCT01041404|Secondary|Percentage of Participants With Confirmed Complete Response (CR) or Partial Response (PR) Determined by Response Evaluation Criteria in Solid Tumors (RECIST)|For TLs, a CR was defined as the disappearance of all TLs and a PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD. For NTLs, a CR was defined as the disappearance of all NTLs and normalization of tumor marker levels.|BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis|FAS||percentage of participants||95% Confidence Interval|Number
810077|NCT01041417|Secondary|Change in Walking Distance Scores on Walking Impairment Questionnaire (WIQ) From Baseline to 3 Months|The WIQ quantifies walking difficulty on a 100-point scale, in which 0 indicates extreme difficulty and 100 indicates no difficulty with walking distance.|Baseline, 3 months|||units on a scale||95% Confidence Interval|Mean
810061|NCT01041404|Secondary|Time to Progression - Time to Event|The median time, in months, from the date of randomized to the date of a TTP event. Participants were censored at the last date of tumor assessment, the last date in the study drug log, or the last date of follow-up.|BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis|FAS||months||95% Confidence Interval|Median
810062|NCT01041404|Secondary|Time to Progression (TTP) - Percentage of Participants With an Event|TTP was defined as the time from the date of randomization and the date of the first occurrence of PD. Participants were censored at the last date of tumor assessment, the last date in the study drug log, or the last date of follow-up.|BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis|FAS||percentage of participants|||Number
810063|NCT01041404|Secondary|Progression-Free Survival - Time to Event|The median time, in months, from the date of randomization to the date of a PFS event. Participants were censored at the last date of tumor measurement, the last date in the study drug log, or the date of last follow-up.|BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis|FAS||months||95% Confidence Interval|Median
810064|NCT01041404|Secondary|Progression-Free Survival (PFS) - Percentage of Participants With an Event|PFS was defined as the time from the date of randomization to the date of the first documentation of progressive disease (PD) or date of death, whichever occurs first. For target lesions (TL), PD was defined as at least a 20 percent (%) increase in the sum of the longest diameter (SLD) of TLs, taking as a reference the smallest SLD recorded since the treatment started, or the appearance of one or more lesions. For non-target lesions (NTL), PD was defined as an unequivocal progression of existing NTLs. Participants were censored at the last date of tumor measurement, the last date in the study drug log, or the date of last follow-up.|BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis|FAS||percentage of participants|||Number
810065|NCT01041404|Primary|Overall Survival (OS) - Percentage of Participants With an Event|OS was defined as the time from the date of randomization to the date of death due to any cause. Participants were censored at the last date of tumor measurement, the last date in the study drug log, or the date of last follow-up.|Baseline (BL), Days 1, 8, 15, 22, 43, 64, 85, 106, 127, and every 21 days until the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis|FAS||percentage of participants|||Number
810066|NCT01041417|Secondary|Change in Score on Physical Functioning Subscale of the Short Form 36 Health Survey (SF-36) From Baseline to 6 Months|The SF-36 is a standard quality of life instrument. The physical functioning represents limitations in physical activities because of health problems. Physical functioning is a summary measure derived from 8 scale scores and the score ranges from 0-100; higher scores indicate better performance.|Baseline, 6 months|||units on a scale||95% Confidence Interval|Mean
810067|NCT01041417|Secondary|Change in Score on Physical Functioning Subscale of the Short Form 36 Health Survey (SF-36) From Baseline to 3 Months|The SF-36 is a standard quality of life instrument. The physical functioning represents limitations in physical activities because of health problems. Physical functioning is a summary measure derived from 8 scale scores and the score ranges from 0-100; higher scores indicate better performance.|Baseline, 3 months|||units on a scale||95% Confidence Interval|Mean
810068|NCT01041417|Secondary|Change in Score on Mental Composite Score (MCS) Subscale of the Short Form 36 Health Survey (SF-36) From Baseline to 6 Months|The SF-36 is a standard quality of life instrument. The MCS represents the the mental burden on quality of life and is a summary of questions related to mental impact of a disease or condition (mental function, role emotional, vitality, and mental health). MCS is a summary measure derived from 8 scale score and the score ranges from 0-100; higher scores indicate better performance.|Baseline, 6 months|||units on a scale||95% Confidence Interval|Mean
810069|NCT01041417|Secondary|Change in Score on Mental Composite Score (MCS) Subscale of the Short Form 36 Health Survey (SF-36) From Baseline to 3 Months|The SF-36 is a standard quality of life instrument. The MCS represents the the mental burden on quality of life and is a summary of questions related to mental impact of a disease or condition (mental function, role emotional, vitality, and mental health). MCS is a summary measure derived from 8 scale score and the score ranges from 0-100; higher scores indicate better performance.|Baseline, 3 months|||units on a scale||95% Confidence Interval|Mean
810070|NCT01041417|Secondary|Change in Score on Physical Composite Score (PCS) Subscale of the Short Form 36 Health Survey (SF-36) From Baseline to 6 Months|The SF-36 is a standard quality of life instrument. The PCS represents the the physical burden on quality of life and is a summary of questions related to physical impact of a disease or condition (physical function, role physical, bodily pain, and general health). PCS is a summary measure derived from 8 scale score and the score ranges from 0-100; higher scores indicate better performance.|Baseline, 6 months|||units on a scale||95% Confidence Interval|Mean
810071|NCT01041417|Secondary|Change in Score on Physical Composite Score (PCS) Subscale of the Short Form 36 Health Survey (SF-36) From Baseline to 3 Months|The SF-36 is a standard quality of life instrument. The PCS represents the the physical burden on quality of life and is a summary of questions related to physical impact of a disease or condition (physical function, role physical, bodily pain, and general health). PCS is a summary measure derived from 8 scale score and the score ranges from 0-100; higher scores indicate better performance.|Baseline, 3 months|||units on a scale||95% Confidence Interval|Mean
810072|NCT01041417|Secondary|Change in Stair Climbing Score on Walking Impairment Questionnaire (WIQ) From Baseline to 6 Months|The WIQ quantifies walking difficulty on a 100-point scale, in which 0 indicates extreme difficulty and 100 indicates no difficulty with stair climbing elements.|Baseline, 6 months|||units on a scale||95% Confidence Interval|Mean
810073|NCT01041417|Secondary|Change in Stair Climbing Score on Walking Impairment Questionnaire (WIQ) From Baseline to 3 Months|The WIQ quantifies walking difficulty on a 100-point scale, in which 0 indicates extreme difficulty and 100 indicates no difficulty with stair climbing elements.|Baseline, 3 months|||units on a scale||95% Confidence Interval|Mean
810074|NCT01041417|Secondary|Change in Walking Speed Score on Walking Impairment Questionnaire (WIQ) From Baseline to 6 Months|The WIQ quantifies walking difficulty on a 100-point scale, in which 0 indicates extreme difficulty and 100 indicates no difficulty with walking speed.|Baseline, 6 months|||units on a scale||95% Confidence Interval|Mean
810078|NCT01041417|Secondary|Change in Claudication Onset Time (COT) From Baseline to 6 Months|Claudication is pain, tired or weak feeling that occurs in the legs, usually during activity such as walking. The COT was measured as the time to onset of the participant's typical claudication as the maximum distance the patient could walk on the treadmill.|Baseline, 6 months|||seconds||95% Confidence Interval|Mean
810079|NCT01041417|Secondary|Change in Claudication Onset Time (COT) From Baseline to 3 Months|Claudication is pain, tired or weak feeling that occurs in the legs, usually during activity such as walking. The COT was measured as the time to onset of the participant's typical claudication as the maximum distance the patient could walk on the treadmill.|Baseline, 3 months|||seconds||95% Confidence Interval|Mean
810080|NCT01041417|Secondary|Change in Peak Walking Time During Treadmill Exercise Tolerance Test From Baseline to 6 Months|Exercise Tolerance Test (ETT) was conducted using the Gardner protocol. Participants exercised on a treadmill, starting at 2.0 mph. The intensity of exercise (speed) was increased in grade of 2% every 2 minutes. Participants were asked to exercise until symptom limitation and the time measured in seconds from the ETT was used for data analysis.|Baseline, 6 months|||seconds||95% Confidence Interval|Mean
810081|NCT01041417|Primary|Change in Peak Walking Time During Treadmill Exercise Tolerance Test From Baseline to 3 Months|Exercise Tolerance Test (ETT) was conducted using the Gardner protocol. Participants exercised on a treadmill, starting at 2.0 mph. The intensity of exercise (speed) was increased in grade of 2% every 2 minutes. Participants were asked to exercise until symptom limitation and the time measured in seconds from the ETT was used for data analysis.|Baseline, 3 months|||seconds||95% Confidence Interval|Mean
810082|NCT01041573|Secondary|Rate of Subjects With Abnormal Laboratory Parameters||study duration||||||
810083|NCT01041573|Secondary|Rate of Subjects With Unsolicited AEs up to Day 56 and up to Month 7||Day 56 and up to Month 7||||||
810084|NCT01041573|Secondary|Rate of Subjects With Solicited Local and Systemic AEs||study duration||||||
810085|NCT01041573|Secondary|Rate of Subjects With SAEs and Medically Attended AEs up to Month 7||up to Month 7||||||
810086|NCT01041573|Secondary|Geometric Mean Titers (GMT) for JEV Neutralizing Antibodies and SCR at Days 0, 56 and at Month 7||Day 0, 56 and at Month 7||||||
810087|NCT01041573|Primary|Rate of Subjects With Serious Adverse Events and Medically Attended Adverse Events Until Day 56 After First Vaccination|Comparing study participants 1 year and above receiving IC51 0.25mL, IC51 0.5 mL and Havrix|until Day 56|||percentage of participants||95% Confidence Interval|Number
810088|NCT01041638|Secondary|Overall Survival|Estimated using Kaplan-Meier curves.|From enrollment until death, or until last contact with the patient, up to 5 years||||||
810089|NCT01041638|Secondary|Event-free Survival|Estimated using Kaplan-Meier curves.|From enrollment until the first occurrence of relapse, progressive disease, secondary malignancy, or death, or until last contact if no event occurred, up to 5 years||||||
810090|NCT01041638|Primary|Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever).|Designed to collect comprehensive safety/toxicity data, as well as additional efficacy data for the immunotherapy. To address the primary objective, descriptive analyses summarizing the number and type of AEs will be performed. The percentage of patients reporting each unacceptable (Grade 3 or higher) CTC toxicity code, tabulated by course, are reported.|Up to 5 years|"There was one patient that did not receive treatment, represented on the baseline form as withdrawal by patient, not included in outcome measure tabulation."||percentage of participants|||Number
810091|NCT01048099|Primary|Part II: Objective Response Rate of Pertuzumab Therapy|The percentage of patients with HER2 activation (no overexpression) as identified by the PRO Onc Assay who experience an objective benefit from treatment, per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|18 months|Includes patients with only HER2 activation (no overexpression) as detected by the PRO Onc Assay||percentage of participants|||Number
810092|NCT01048099|Primary|Part II: Objective Response Rate of Trastuzumab Therapy|The percentage of patients having an objective benefit from treatment per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Includes patients with HER2 overexpression as identified by the PRO Onc Assay.|18 months|Includes patients with HER2 overexpression detected by the PRO Onc Assay||percentage of participants|||Number
810093|NCT01048099|Secondary|Part I: The Incidence of Isolation of Circulating Tumor Cells (CTCs) From Blood Specimens|Percentage of HER2-negative MBC patients (identified by FISH testing) having CTCs present in blood specimens.|12 months|Includes all patients with blood drawn and analyzed for CTCs||percentage of participants|||Number
810094|NCT01048099|Primary|Part II: Objective Response Rate of HER2-negative Metastatic Breast Cancer (by FISH Testing)|The percentage of HER2-negative metastatic breast cancer (MBC) patients having an objective benefit from treatment per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Includes patients with HER2 overexpression/activation as detected by PRO Onc Assay.|18 months|||percentage of participants|||Number
810095|NCT01048099|Secondary|Part 1: The Incidence of HER2 Overexpression/Activation as Measured by the PRO Onc Assay|Includes patients with HER2-negative metastatic breast cancer (MBC) as determined by FISH testing.|12 months|||participants|||Number
810096|NCT01048125|Primary|Identifying Risk Factors and Developing Strategies to Prevent the Occurrence of Stress Cardiomyopathy in Situations Where the Likelihood in Susceptible Individuals May be High.||2 years|Due to difficulty in recruitment and resource restraints the study did not progress as expected and was closed.|||||
810097|NCT01048242|Primary|Sleep Onset Latency|Time to sleep onset as determined by polysomnography|4 weeks|analysis per protocol||minutes||Standard Deviation|Mean
810098|NCT01048333|Secondary|Adverse Events|Number of participants with at least 1 AE.|At baseline and at each day of treatment|||Participants|||Number
810730|NCT01048606|Primary|Quality of Life: Assessed With Questionnaires (SF-36 (General Health Perceptions), Kupperman Index, Perceived Stress Scale.||Baseline||||||
810099|NCT01048333|Secondary|Percentage of Patients Who Has Achieved at Least 12 % Increase in FEV1|Percentage of patients who has achieved at least 12 % increase in FEV1 at each time point between 5 to 120 minutes post dose, change versus pre dose FEV1|Pre dose, 5, 10, 15, 20, 30, 40, 50, 60 and 120 minutes post dose|||Percentage of Participants|||Number
810100|NCT01048333|Secondary|Average FEV1 During 120 Minutes Post Dose|Average FEV1 during 120 minutes post dose, change versus pre dose FEV1|Pre dose and 120 minutes post dose|||percentage change||95% Confidence Interval|Geometric Mean
810101|NCT01048333|Secondary|Average FEV1 During the First 15 Minutes Post Dose|Average FEV1 during the first 15 minutes post dose, change versus pre dose FEV1|Pre dose and 15 minutes post dose|||percentage change||95% Confidence Interval|Geometric Mean
810102|NCT01048333|Primary|FEV1(Forced Expiratory Volume in 1 Second) Measured by Spirometry 5 Minutes Post Dose|FEV1(Forced Expiratory Volume in 1 second) measured by spirometry 5 minutes post dose, percentage change versus pre dose FEV1|Pre-dose and 5 minutes post-dose|||percentage change||95% Confidence Interval|Geometric Mean
810103|NCT01048697|Primary|Total Clearance of Ethambutol||Blood samples will be collected over a 24 hour period (0, 2, 6, 11, 18, and 24 hours)|||L/h||Standard Deviation|Mean
810104|NCT01048723|Secondary|Number of Participants With Memory CD8 T Cell Enhanced Production|Memory CD8 T cell enhanced production as determined by fluorescence activated cell sorter (FACS) analysis on blood and tumor core biopsy specimens taken before and after therapy with RAD001. Our planned analysis was for 40 participants.|Pre and Post the 2 week treatment||||||
810105|NCT01048723|Secondary|Number of Participants With Pathological Response|We planned to determine pathological response in terms of tumor necrosis and apoptosis assessed on the resected specimens after 2 weeks of RAD001 therapy. Percent necrosis was to be reported based on the routine H and E staining. In addition to cleaved PARP analysis, TUNEL assays were to be performed judging the amount of apoptosis in the specimens after treatment. Our planned analysis was for 40 participants.|Post the 2 week treatment||||||
810106|NCT01048723|Secondary|PD Markers (p70S6K, S6-RP, P-AKT, Cleaved PARP and PCNA)|Quantitative in vivo and ex vivo assessments of PD markers (p70S6K, S6-RP, P-AKT, cleaved PARP and PCNA) were to be normalized within the same sample. The extent of inhibition is defined as the fractional inhibition in each patient calculated as [(PreRx normalized PD marker – PostRx normalized PD marker) / PreRx normalized PD marker] x 100. Same definition would apply to each of these markers. Our planned analysis was for 40 participants.|Post the 2 week treatment||||||
810107|NCT01048723|Primary|Pharmacodynamics (PD) Markers|PD markers of RAD001 on downstream signaling pathways in patients with sarcomas: p70S6K, S6-RP, P-AKT, cleaved PARP and PCNA by Western blot, quantitative multiplex assays and immunohistochemical studies measured pre and post the 2 week treatment of RAD001. Patients were to be separated into two groups, responders and non responders based on PD results and downstream up regulation of the referenced pathways. Mean fractional inhibition of each PD marker for the responding and non-responding groups were to be calculated. Our planned analysis was for 40 participants.|Pre and post the 2 week treatment||||||
810108|NCT01048788|Primary|Body Weight|Changes in body weight from baseline at the end of administration|Baseline, Day 14 or end of administration|||Kg||Standard Deviation|Mean
810109|NCT01048866|Secondary|Change From Baseline in Body Temperature at End of Study||baseline (pre-dose), up to Day 7|Safety population of participants with a recording at the end of study visit.||degrees Fahrenheit||Standard Deviation|Mean
810110|NCT01048866|Secondary|Change From Baseline in Body Temperature at 2 Hours Post Initial Dose||baseline (pre-dose), 2 hours post-dose|Safety population||degrees Fahrenheit||Standard Deviation|Mean
810111|NCT01048866|Secondary|Time to First Rescue Pain Medication|Participants were allowed a dose of rescue medication (acetaminophen 650mg), as needed, post-treatment during the study. Time from initial dose to first rescue medication is summarized by time categories.|Days 1-7|Intent to treat population||percentage of participants|||Number
810112|NCT01048866|Secondary|Percentage of Participants Who Took Rescue Pain Medication|Participants were allowed a dose of rescue medication (acetaminophen 650mg), as needed, post-treatment dosing during the study.|Days 1-7|Intent to treat population||percentage of participants|||Number
810113|NCT01048866|Secondary|Post 24 Hour, Multiple Dose Results: Sore Throat Relief As Reported by Participants 2 Hours After Dosing|"Participants graded the relief of his/her sore throat at 2 hours after taking a lozenge for all lozenges taken after the initial 24-hours post-baseline using the Sore Throat Relief Rating Scale (STRRS), which is a 6-category relief scale.
The patient was instructed to swallow and:
“Considering how your throat felt before you took the study medicine, circle the phrase that best describes the relief of your sore throat now.” Responses following each lozenge were no relief, slight, mild, moderate, considerable, and complete relief. Results summarize responses 2 hours after taking each lozenge."|Days 2-7|Intent to treat population of participants who were active in the study on day 2||percentage of doses|Lozenges (doses)||Number
810114|NCT01048866|Secondary|Post 24 Hour, Multiple Dose Results: Weighted Sum of Differences Over 2 Hours for Swollen Throat Scale (SwoTS2)|"The time weighted summed differences over 2 hours after taking a lozenge for all lozenges taken after the initial 24-hours post-baseline.
The participant was asked to evaluate how swollen his/her throat felt using a 100-mm visual analog scale prior to dosing, and 1 hour and 2 hours post dose.
The patient was instructed to swallow and “Place a line on the scale that best characterizes how swollen your throat feels now.” A mark at 0-mm indicated not swollen and 100-mm indicated very swollen. Data for multiple doses/days were averaged to obtain the values used for calculating SWoTS2. The full range for differences was -5396 to 6604 with negative values indicating improvement in pain intensity.
Assessments were summarized using a repeated measures mixed model, with treatment and center as a fixed effect, time since Baseline as a covariate, and a random effect for participants."|Days 2-7|Intent to treat population of participants who were active in the study on day 2||units on a scale||Standard Error|Least Squares Mean
810141|NCT01049217|Other Pre-specified|Body Weight||Screening, Week 1, 4, 8, 12, 16, 17|Safety population included all participants who signed the informed consent, had exposure to study drug and had at least one safety assessment. n = participants evaluable for this measure at specified time points for each arm group, respectively.||kilogram||Standard Deviation|Mean
810313|NCT01050764|Primary|Maximum-tolerated Dose (MTD) of Regulatory and Conventional T-cells|The maximum-tolerated dose (MTD) was to be determined based on the safety and feasibility observed for a pre-determined set of cellular dose level combinations of regulatory T-cells (T-reg) and conventional T-cells (T-con).|30 days after HSCT infusion|Includes all participants that received HSCT||cells/kg|||Number
810115|NCT01048866|Secondary|Post 24 Hour, Multiple Dose Results: Weighted Sum of Differences Over 2 Hours for Difficulty Swallowing Scale (DSS2)|"The time weighted summed differences over 2 hours after taking a lozenge for all lozenges taken after the initial 24-hours post-baseline.
To measure the functional effect on pharyngitis, the participant was asked to evaluate his/her difficulty swallowing (dysphagia) using a 100-mm visual analog scale prior to dosing, and 1 hour and 2 hours post dose. The participant was instructed to swallow and “Place a line on the scale that best characterizes how difficult it is to swallow now.” A mark at 0-mm indicated not difficult and 100-mm indicated very difficult. Data for multiple doses/days were averaged to obtain the values used for calculating DSS2. The full range for differences was -5626 to 6374 with negative values indicating improvement in pain intensity.
Assessments were summarized using a repeated measures mixed model, with treatment and center as a fixed effect, time since Baseline as a covariate, and a random effect for participants."|Days 2-7|Intent to treat population of participants who were active in the study on day 2. For doses where rescue medication was taken within the 2 hour assessment, all following differences were imputed as zero.||units on a scale||Standard Error|Least Squares Mean
810116|NCT01048866|Secondary|Post 24 Hour, Multiple Dose Results: Weighted Sum of Pain Intensity Differences (SPID) Over 2 Hours for the Sore Throat Pain Intensity Scale (STPIS SPID2)|"The time weighted summed differences over 2 hours after taking a lozenge after the initial 24-hours post-baseline.
STPIS is a validated 100-mm visual analog scale completed by participants that measures “pain on swallowing” (odynophagia). A mark at 0-mm indicates no pain and 100-mm indicates severe pain. SPID2 was calculated as the sum of the time-weighted pain intensity differences from a measurement taken prior to taking a lozenge and at hours 1 + 2 after taking the lozenge during Days 2-7. Data for multiple doses/days were averaged to obtain the values used for calculating SPID2. The full range for SPID2 was -5843 to 6157 with negative values indicating improvement in pain intensity. Assessments were summarized using a repeated measures mixed model, with treatment and center as a fixed effect, time since Baseline as a covariate, and a random effect for participants."|Days 2-7|Intent to treat population of participants who were active in the study on day 2. For doses where rescue medication was taken within the 2 hour assessment, all following differences were imputed as zero.||units on a scale||Standard Error|Least Squares Mean
810117|NCT01048866|Secondary|Investigators’ Clinical Assessment (CLIN) Of Study Medication as a Treatment for Sore Throat at End of Study (Day 7)|Investigators assessed the effectiveness of study medication on the patient’s sore throat at the end of study by answering the following question: “Considering the patient’s response to the study medicine over the past 7 days, how do you rate the study medicine as a treatment for sore throat?” Responses were poor, fair, good, very good or excellent.|Day 7 (end of study)|Intent to treat population of participants who completed the study. CLIN was missing for one flurbiprofen participant.||percentage of participants|||Number
810118|NCT01048866|Secondary|Participant Satisfaction Score 24 Hours After Initial Dose|After 24 hours of treatment, participants rated their satisfaction with the treatment on a 7-step scale from extremely dissatisfied to extremely satisfied.|24 hours|Intent to treat population. One placebo participant did not complete a Patient Satisfaction Score.||percentage of participants|||Number
810119|NCT01048866|Secondary|Investigators’ Clinical Assessment (CLIN) Of Study Medication as a Treatment for Sore Throat at 24 Hours After Initial Dose|Investigators assessed the effectiveness of study medication on the patient’s sore throat at 24 hours following initial dose by answering the following question: “Considering the patient’s response to the study medicine over the past 24 hours, how do you rate the study medicine as a treatment for sore throat?” Responses were poor, fair, good, very good or excellent.|24 hours|Intent to treat population. CLIN was not performed for 3 participants (1 Flurbiprofen, 2 placebo).||percentage of participants|||Number
810120|NCT01048866|Secondary|Sore Throat Relief As Reported by Participants 2 Hours After Initial Dose|"Participants graded the relief of his/her sore throat at 2 hours post initial dose using the Sore Throat Relief Rating Scale (STRRS), which is a 6-category relief scale.
The patient was instructed to swallow and asked:
“Considering how your throat felt before you took the study medicine, circle the phrase that best describes the relief of your sore throat now.” Responses were no relief, slight, mild, moderate, considerable, and complete relief."|2 hours|Intent to treat population||percentage of participants|||Number
810121|NCT01048866|Secondary|Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale Over 24 Hours Post-baseline (STPIS SPID24) For Participants With Baseline Practitioner’s Assessment of Pharyngeal Inflammation (PAIN) of Moderate or Severe|"STPIS measures sore throat pain intensity on a 100-mm visual analog scale completed by participants. A mark at 0-mm indicates no pain upon swallowing and 100-mm indicates severe pain. For the subgroup of patients with moderate/severe pharyngeal inflammation at baseline, SPID24 was calculated as the sum of the time weighted pain intensity differences from baseline until 24 hours. Taking inclusion criteria into account, the full range was -115695 (no pain at any post-dose time (0) – average baseline) to 28505 (maximum possible pain (100) – average baseline).
Participants with their last recorded time point <21 hours were considered Not Evaluable. If a participant used rescue medication, all post-rescue STPIS values in the 24-hour interval were assigned the baseline value for STPIS. Missing scores of STPIS with non-missing STPIS scores at earlier and later assessments were imput"|baseline (pre-dose), 24 hours post dose (measured each hour post dose)|Intent to treat population of participants who took the first full dose of medication and had moderate or severe pharyngeal inflammation at baseline.||units on a scale||Standard Deviation|Mean
810122|NCT01048866|Secondary|Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) Over the 2 Hours Post-baseline (STPIS SPID2)|"STPIS measures sore throat pain intensity on a 100-mm visual analog scale completed by participants. A mark at 0-mm indicates no pain upon swallowing and 100-mm indicates severe pain. SPID2 was calculated as the sum of the time weighted pain intensity differences from baseline until 2 hours post dose. The full range was -9492 (complete pain relief within one hour of dosing that lasts 2 hours) to 2508 (maximum pain within 1 hour lasting 2 hours) using the mean baseline STPIS.
If a participant used rescue medication (acetaminophen 650mg was allowed as needed post dose), all post-rescue STPIS values in the 24-hour interval were assigned the baseline value for STPIS. Missing scores of STPIS with non-missing STPIS scores at earlier and later assessments (recorded or derived due to rescue) were imputed using linear interpolation assuming the time of the missing assessment to be the nominal time since initial dose."|baseline (pre-dose), post-dose: 1 hour, 2 hours|Intent to treat population||units on a scale||Standard Deviation|Mean
810199|NCT01049373|Secondary|Change in State of Health (BF-S)||following 2 weeks treatment||||||
810123|NCT01048866|Secondary|Time Weighted Summed Differences in Swollen Throat Scale (SwoTS) During the Initial 24 Hours From Baseline|"SwoTS measures how swollen a participant's throat felt using a 100-mm visual analog scale completed by participants. Participants were instructed to swallow and Place a line on the scale that best characterizes how swollen your throat feels now. A mark at 0-mm indicated not swollen and 100-mm indicated very swollen.
The full range of the sum of the time-weighted swollen throat differences from baseline until 24 hours was -100320 (throat did not feel swollen at all within 1 hour of dosing and lasted 24 hours) to 31680 (maximum swollen throat reported within 1 hour and lasting 24 hours) using the mean baseline SwoTS. Negative values for differences indicate improvement."|Baseline (pre-dose), hourly readings to 24 hours post-dose|Intent to treat population. Four participants (2 Flurbiprofen, 2 Vehicle) did not have SwoTS recorded after 21 hours and were not included in the analysis.||units on a scale||Standard Deviation|Mean
810124|NCT01048866|Secondary|Time Weighted Summed Differences in Swollen Throat Scale (SwoTS) During the Initial 2 Hours From Baseline|"SwoTS measures how swollen a participant's throat felt using a 100-mm visual analog scale completed by participants. Participants were instructed to swallow and Place a line on the scale that best characterizes how swollen your throat feels now. A mark at 0-mm indicated not swollen and 100-mm indicated very swollen.
The full range of the sum of the time-weighted swollen throat differences from baseline until 2 hours was -9120 (throat did not feel swollen at all within 1 hour of dosing and lasted 2 hours) to 2880 (maximum swollen throat reported within 1 hour and lasting 2 hours) using the mean baseline SwoTS.
Negative values for the differences indicate improvement. Missing values of SwoTS with non-missing values at assessments before and after were calculated using linear interpolation."|Baseline (pre-dose), hourly readings to 2 hours post-dose|Intent to treat population of participants who took the first full dose of medication||units on a scale||Standard Deviation|Mean
810125|NCT01048866|Secondary|Time Weighted Summed Differences in Difficulty Swallowing Scale (DSS) During the Initial 24 Hours From Baseline|"DSS measures difficulty swallowing (dysphagia) using a 100-mm visual analog scale completed by participants. Participants were instructed to swallow and Place a line on the scale that best characterizes how difficult it is to swallow now. A mark at 0-mm indicated not difficult and 100-mm indicated very difficult.
Data are reported as the sum of the time-weighted pain intensity differences from baseline until 24 hours post dose. The full range was -102960 (no difficulty swallowing within 1 hour of dosing that lasts 24 hours) to 29040 (maximum difficulty swallowing within 1 hour of dosing lasting 24 hours) using the baseline DSS value. Negative values indicate improvement in difficulty swallowing.
Missing values of DSS with non-missing values at assessments before and after were calculated using linear interpolation."|Baseline (pre-dose), hourly readings to 24 hours post-dose|Intent to treat population. Four participants (2 Flurbiprofen and 2 placebo) did not have DSS recorded after 21 hours and were not included in the analysis.||units on a scale||Standard Deviation|Mean
810126|NCT01048866|Secondary|Time Weighted Summed Differences in Difficulty Swallowing Scale (DSS) During the Initial 2 Hours From Baseline|"DSS measures difficulty swallowing (dysphagia) using a 100-mm visual analog scale completed by participants. Participants were instructed to swallow and Place a line on the scale that best characterizes how difficult it is to swallow now. A mark at 0-mm indicated not difficult and 100-mm indicated very difficult.
Data are reported as the sum of the time-weighted pain intensity differences from baseline until 2 hours post dose. The full range was -9360 (no difficulty swallowing within 1 hour of dosing that lasts 2 hours) to 2640 (maximum difficulty swallowing within 1 hour of dosing lasting 2 hours) using the baseline DSS value.
Missing values of DSS with non-missing values at assessments before and after were calculated using linear interpolation."|Baseline (pre-dose), Hours 1 and 2 post-dose|Intent to treat population of participants who took the first full dose of medication||units on a scale||Standard Deviation|Mean
810127|NCT01048866|Primary|Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) Over the 24 Hours Post-baseline (STPIS SPID24)|"STPIS measures sore throat pain intensity on a 100-mm visual analog scale completed by participants. A mark at 0-mm indicates no pain upon swallowing and 100-mm indicates severe pain. SPID24 was calculated as the sum of the time weighted pain intensity differences from baseline until 24 hours. The full range was -104412 (complete pain relief within 1 hour of dosing that lasts 24 hours) to 27588 (maximum pain within 1 hour lasting 24 hours) using the mean baseline STPIS.
Participants with a last recorded time point <21 hours were considered Not Evaluable. If a participant used rescue medication, all post-rescue STPIS values in the 24-hour interval were assigned the baseline value for STPIS. Missing scores of STPIS with non-missing STPIS scores at earlier and later assessments were imputed using linear interpolation assuming the time of the missing assessment to be the nominal time since initial dose."|baseline (pre-dose), post-dose - hourly up to 24 hours|Intent to treat population of participants who took the first full dose of medication, and had STPIS values recorded >= 21 hours post initial dose. Four participants (2 Flurbiprofen, 2 placebo) did not have sufficient 24 hour data to be included in the primary analysis of the primary endpoint.||units on a scale||Standard Deviation|Mean
810128|NCT01048879|Primary|Oseltamivir Carboxylate Removal by ECMO|Mean percent change in oseltamivir carboxylate concentration pre- and post-oxygenator.|12 hours|All of the patients that received ECMO were included. Patients receiving CVVHD Alone did not receive ECMO and were not included.||percent change in concentration||Standard Deviation|Mean
810129|NCT01048879|Primary|Continuous Venovenous Hemodialysis (CVVHD)Oseltamivir Carboxylate Transmembrane Clearance|Oseltamivir Carboxylate Transmembrane Clearance by Continuous Venovenous Hemodialysis (Reported in mL/min).|12 hours|One patient in the CVVHD Alone group was excluded from the analysis because not enough data points were available for pharmacokinetic modeling.||mL/min||Standard Deviation|Mean
810130|NCT01048944|Primary|Changes in Log of Smoking Withdrawal Scores (Mood, and Depressive Symptoms) From Baseline Across 66 Days of Abstinence|"Changes in log from baseline in the widely used Shiffman-Jarvik Withdrawal craving and psychological symptom scores through 66 days of abstinence. Post-quit changes were assessed at days 3, 24, 45, and 66 of abstinence. The maximal range of value raw for craving is from 5 = (no craving) to 47 (maximally strong craving), while that for psychological symptoms is from 5 (no symptoms) to 60 (maximally intense symptoms of across multiple symptoms). Because the subtraction of logs is equivalent to the ratio of the two scores, a difference in logs (base 10) with a value of 1 is equal to an increase by a factor of 10, while a value of 0 is no change, and values of less than 0 are decreases below baseline values."|Changes in log withdrawal symptoms from baseline through 66 days of abstinence|Analysis population included only those individuals who complied fully with study requirements through 67 days of abstinence.||log (base 10) units on a scale||Standard Error|Mean
810131|NCT01048944|Primary|Changes in Log Brain-wave (EEG) Activity (Power [Microvolts Squared]) From Pre-quit Baseline to 66 Days Post-quit, Assessed at 3, 24, 45, and 66 Days Post-quit.|Brain-wave activity (EEG) was assessed using electrodes on the subject's scalp, the outputs of which were and quantified by a commercial brain wave machine. EEG was collected at frontal (e.g., Fz) and parietal (e.g., Pz) electrodes while subjects relaxed. EEG was analyzed using computer programs that measured slow-frequency EEG waves known as delta (1.5-4.5 cycles/second [cps]), theta-1 (4.5-6.0 cps), theta-2 (6.0-7.7 cps), and alpha-1 (7.8-10.0 cps), and higher frequency waves. Generally, delta, alpha-1 and theta waves reflect deactivation of the brain activity, while higher frequency waves reflect greater brain activation. Brain activity was quantified as the natural log of EEG power [microvolts squared] as determined by the fast Fourier mathematical algorithm. Days post quit were components of Time. The primary focus was on changes in the individual subject's log theta-1, theta-2, and alpha-1 power at post-quit points in time minus the log values at the pre-quite baseline.|Mean EEG power [microvolts squared] from at baseline, 3, 24, 45, and 66 days post-quit|For the currently reported analyses, only individuals complying with the study requirements, including biochemically verified smoking abstinence, were assessed. Future analyses will include individuals who complied to certain critical endpoints.||Change in log EEG [microvolts squared]||Standard Error|Mean
810132|NCT01049009|Primary|Endothelial Function Measured by Forearm Blood Flow (FBF) at 24 Weeks|Forearm blood flow measured by venous occlusion plethysmography at rest, after administration of N(G)-monomethyl-L-arginine (L-NMMA) and tetraethylammonium chloride (TEA), after administration of L-NMMA, TEA, and acetylcholine, and after administration of L-NMMA, TEA, and exercise. Unit of Measure refers to volume of blood (mL) per 100 mL of forearm tissue per minute.|24 weeks|||mL/100 mL/min||Standard Deviation|Mean
810133|NCT01049009|Primary|Endothelial Function Measured by Forearm Blood Flow (FBF) at 12 Weeks|Forearm blood flow measured by venous occlusion plethysmography at rest, after administration of N(G)-monomethyl-L-arginine (L-NMMA) and tetraethylammonium chloride (TEA), after administration of L-NMMA, TEA, and acetylcholine, and after administration of L-NMMA, TEA, and exercise. Unit of Measure refers to volume of blood (mL) per 100 mL of forearm tissue per minute.|12 weeks|||mL/100 mL/min||Standard Deviation|Mean
810134|NCT01049217|Secondary|Diagnostic Neuropathy Assessment||Screening|Data were not collected since this was a screening tool for investigators and there was no analysis planned for this measure.|||||
810135|NCT01049217|Other Pre-specified|Number of Participants With Response to Patient Health Questionnaire–8 (PHQ-8)|PHQ-8: 8-item self-administered validated subset of PHQ-9, which comprises first 8 items of measure. Participant rated “Over past 2 weeks, how often bothered by any of following problems?”: little interest in doing things(1); feeling down(2); trouble falling or staying asleep/sleeping too much(3); feeling tired(4); poor appetite/overeating(5); feeling bad about self(6); trouble concentrating(7); moving or speaking slowly or being so fidgety/moving around more than usual (8). Each item scored on scale of 0(not at all)-3(nearly every day). Total score range: 0-24, higher score=greater severity.|Screening|ITT population: all randomized participants who took at least 1 dose of study drug. n = participants evaluable for this measure at specified time points for each arm group, respectively.||participants|||Number
810136|NCT01049217|Other Pre-specified|Number of Participants With Response to Sheehan-Suicidality Tracking Scale (S-STS) Mapped to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories|S-STS:8-item clinician/participant administered prospective rating scale to assess TE suicidal(Su) ideation(ID),behavior(BHV).Items 1a,2-6,7a,8 scored on 5-point Likert scale 0(not at all) to 4(extremely). Items 1,1b,7 require yes/no response. S-STS total score range 0-30. Lower score=reduced Su tendency. Responses on S-STS were mapped to Columbia Classification Algorithm of Suicide Assessment(C-CASA) as 1:Completed Su; 2: Su attempt; 3: Preparatory acts; 4: Su ID; 5: Self-injurious (SI) BHV, intent unknown; 6: Not enough information; 7: SI BHV, no Su intent; 8: Other, no deliberate self harm.|Screening, Post-Baseline (Week 4 up to Week 17)|Safety population included all participants who signed the informed consent, had exposure to study drug and had at least one safety assessment. n = participants evaluable for this measure at specified time points for each arm group, respectively.||participants|||Number
810137|NCT01049217|Other Pre-specified|Number of Participants Who Met Mini-International Neuropsychiatric Interview (MINI) Criteria|MINI: short structured clinical interview to make diagnoses of psychiatric disorders according to Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) or International Classifications of Disease-10 (ICD-10). In the MINI Modules, participants were asked a series of Yes/No questions.|Screening|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis.|||||
810138|NCT01049217|Other Pre-specified|Number of Participants With Neurological Examination Findings|A neurological examination consisted of examination of the mental state, cranial nerve function, motor function (reflexes of patellar, achilles, biceps, babinski and coordination) and sensory function (sharp sensation of dorsal surface of right and left great toe, light touch of lower extremities [LE], right and left first metatarsal joint position sense, and vibration sensation [vibration is felt for < 6 seconds = markedly diminished, 6 to 10 seconds = mild loss, > 10 seconds = normal]).|Screening|Safety population included all participants who signed the informed consent, had exposure to study drug and had at least one safety assessment.||participants|||Number
810139|NCT01049217|Other Pre-specified|Sitting Heart Rate||Screening, Week 1, 4, 8, 12, 16, 17|Safety population included all participants who signed the informed consent, had exposure to study drug and had at least one safety assessment. n = participants evaluable for this measure at specified time points for each arm group, respectively.||beats per minute (bpm)||Standard Deviation|Mean
810140|NCT01049217|Other Pre-specified|Sitting Systolic and Diastolic Blood Pressure|Systolic Blood Pressure (SBP) is the blood pressure (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. Diastolic Blood Pressure (DBP) is the blood pressure (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart.|Screening, Week 1, 4, 8, 12, 16, 17|Safety population included all participants who signed the informed consent, had exposure to study drug and had at least one safety assessment. n = participants evaluable for this measure at specified time points for each arm group, respectively.||millimeter of mercury (mmHg)||Standard Deviation|Mean
810200|NCT01049373|Secondary|Change in Strength of Pain (Visual Analog Scale VAS)||following 15 weeks treatment||||||
810142|NCT01049217|Other Pre-specified|Number of Participants With Abnormal Physical Examination Findings|A physical examination included an examination of the general appearance, skin, chest, pulses, pulmonary, cardiovascular, head, eyes, ears, nose, throat, abdominal, and extremities.|Screening, Week 8, 17|Safety population included all participants who signed the informed consent, had exposure to open label study drug and had at least one safety assessment. n = participants evaluable for this measure at specified time points for each arm group.||participants|||Number
810143|NCT01049217|Other Pre-specified|Number of Participants With Positive Serum and Urine Pregnancy|Serum pregnancy test (regardless of childbearing potential) and urine pregnancy test for all female participants were performed.|Screening for serum pregnancy test, Week 1 for urine pregnancy test|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis.|||||
810144|NCT01049217|Other Pre-specified|Number of Participants With Abnormal Laboratory Test Findings|Laboratory tests included hematology, chemistry, cluster of differentiation 4 (CD4) count and cluster of differentiation 8 (CD8) count, HIV plasma viral load, B12, Venereal Disease Research Laboratory (VDRL), toxic screens for drugs and alcohol, reflex thyroid-stimulating hormone (TSH), urinalysis. Number of participants with a laboratory abnormality meeting specified criteria while on study treatment or during lag time was reported.|Screening up to Week 17|Safety population included all participants who signed the informed consent, had exposure to study drug and had at least one safety assessment. N (number of participants analyzed) signifies those participants who were evaluable for this measure.||participants|||Number
810145|NCT01049217|Other Pre-specified|Number of Participants With Treatment-Emergent (TE) Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to 28 days after last dose|Safety population included all participants who signed the informed consent, had exposure to study drug and had at least one safety assessment.||participants|||Number
810146|NCT01049217|Secondary|Productivity and Activity Impairment Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire|WPAI: 6-question participant rated questionnaire to determine the degree to which SHP affected work productivity while at work and affected activities outside of work. It assesses amount of absenteeism, presenteeism and daily activity impairment attributable to a HIV neuropathy pain. Question 5 and 6 assesses: How much leg/foot pain affect productivity and daily activity, respectively in past 7 days? on 11-point scale, where 0 (not affected/no impairment) to 10 (completely affected/impaired).|Baseline, Week 16, 17|ITT population: all randomized participants who took at least 1 dose of study drug. n = participants evaluable for this measure at specified time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
810147|NCT01049217|Secondary|Absenteeism and Presenteeism Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire|WPAI: 6-question participant rated questionnaire to determine the degree to which SHP affected work productivity while at work and affected activities outside of work. It assesses amount of absenteeism, presenteeism and daily activity impairment attributable to a HIV neuropathy pain. Question 2 and 3 assesses absenteeism as: Hours of work missed in past 7 days due to leg/foot pain or other reason, respectively. Question 4 assesses presenteeism as: Hours of work performed in past 7 days. A participant who had responded 'no' to question 1 regarding employment status reported hours of work and as this was a self-reported questionnaire the source data were included.|Baseline, Week 16, 17|ITT population: all randomized participants who took at least 1 dose of study drug. N (number of participants analyzed) signifies those participants who were evaluable for this measure. n = participants evaluable for this measure at specified time points for each arm group, respectively.||hours||Standard Deviation|Mean
810148|NCT01049217|Secondary|Number of Participants Who Were Employed or Unemployed Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire|WPAI: 6-question participant rated questionnaire to determine the degree to which specific health problem (SHP) affected work productivity while at work and affected activities outside of work. It assesses amount of absenteeism, presenteeism and daily activity impairment attributable to a HIV neuropathy pain. Number of participants who responded “Yes/No” to Question 1: Are you currently employed (working for pay)? are reported.|Baseline, Week 16, 17|ITT population: all randomized participants who took at least 1 dose of study drug. n = participants evaluable for this measure at specified time points for each arm group, respectively.||participants|||Number
810149|NCT01049217|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Endpoint (up to Week 16)|SF-36 is a standardized survey evaluating 8 domains of functional health and well being: physical and social (So) functioning (Fn), physical and emotional role (role-physical [R-P], role-emotional [R-E]) limitations, bodily pain (BP), general health (GH), vitality (Vit), mental health (MnH). Two summary scores include Physical Component (Ph C) and Mental Component (Mn C). The score for a section is an average of the individual question scores. Score range for domain scores and summary scores: 0-100 (100=highest level of functioning).|Baseline, Endpoint (up to Week 16)|ITT population: all randomized participants who took at least 1 dose of study drug. n = participants evaluable for this measure at specified time points for each arm group, respectively. Missing data for endpoint (up to Week 16) imputed using LOCF.||units on a scale||Standard Deviation|Mean
810150|NCT01049217|Secondary|Change From Baseline in Hospital Anxiety and Depression Scales (HADS) at Endpoint (up to Week 16)|HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms. Endpoint was the last observation for a participant assessed using imputation method.|Baseline, Endpoint (up to Week 16)|ITT population: all randomized participants who took at least 1 dose of study drug. n = participants evaluable for this measure at specified time points for each arm group, respectively. Missing data for endpoint (up to Week 16) imputed using LOCF.||units on a scale||Standard Deviation|Mean
810151|NCT01049217|Secondary|Medical Outcomes Study-Sleep Scale (MOS-SS): Number of Participants With Optimal Sleep|MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awaken short of breath or with headache, sleep adequacy, somnolence, sleep quantity, optimal sleep, and 9 item index measures of sleep disturbance provide composite scores: sleep problems index. Participants responded whether their sleep was optimal or not optimal by choosing yes or no. Endpoint was the last observation for a participant assessed using imputation method.|Baseline, Endpoint (up to Week 16)|ITT population: all randomized participants who took at least 1 dose of study drug. n = participants evaluable for this measure at specified time points for each arm group, respectively. Missing data for endpoint (up to Week 16) imputed using LOCF.||participants|||Number
810152|NCT01049217|Secondary|Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Endpoint (up to Week 16)|Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales: sleep disturbance (range 0-100), snoring (range 0-100), awaken short of breath (SOB) or with headache (range 0-100), sleep adequacy (range 0-100), somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes/no), and 9 item index measures of sleep disturbance provide composite scores: sleep problems index (range 0-100). Except adequacy, optimal sleep and quantity, higher scores=more impairment. Endpoint was the last observation for a participant assessed using imputation method.|Baseline, Endpoint (up to Week 16)|ITT population: all randomized participants who took at least 1 dose of study drug. n = participants evaluable for this measure at specified time points for each arm group, respectively. Missing data for endpoint (up to Week 16) imputed using LOCF.||units on a scale||Standard Deviation|Mean
810153|NCT01049217|Secondary|Percentage Day Time Above Sedentary Level|Percentage of time above sedentary level is number of epochs (60 seconds) with greater than (>) 200 activity counts per minute divided by total number of epochs during the “day” (non sleep period) multiplied by 100. This was determined by actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to record movements while the device was being worn. Endpoint was the last observation for a participant assessed using specified imputation method.|Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16, Endpoint (up to Week 16)|ITT population. N (number of participants analyzed) = participants evaluable for this measure. Missing data for endpoint (up to Week 16) imputed using LOCF. Data for Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16 were collected and reported in individual participant listings but not statistically summarized for analysis.||percentage of day time||Standard Error|Least Squares Mean
810154|NCT01049217|Secondary|Total Activity Counts|"Activity counts are the units of motion. It is equal to the sum of peak accelerations each second during the epoch (60 seconds). Total activity counts per day is the sum of the activity counts for each epoch (60 seconds) during the day (non sleep period). A total activity count was determined by actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to record movements while the device was being worn. Endpoint was the last observation for a participant assessed using specified imputation method."|Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16, Endpoint (up to Week 16)|ITT population. N (number of participants analyzed) = participants evaluable for this measure. Missing data for endpoint (up to Week 16) imputed using LOCF. Data for Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16 were collected and reported in individual participant listings but not statistically summarized for analysis.||activity counts per day||Standard Error|Least Squares Mean
810155|NCT01049217|Secondary|Sleep Efficiency|Sleep efficiency is the time spent asleep divided by total time between sleep onset and sleep end, multiplied by 100. Sleep efficiency was determined by actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to record movements while the device was being worn. Endpoint was the last observation for a participant assessed using specified imputation method.|Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16, Endpoint (up to Week 16)|ITT population. N (number of participants analyzed) = participants evaluable for this measure. Missing data for endpoint (up to Week 16) imputed using LOCF. Data for Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16 were collected and reported in individual participant listings but not statistically summarized for analysis.||Percent time between sleep onset and end||Standard Error|Least Squares Mean
810156|NCT01049217|Secondary|Sleep Fragmentation Index (SFI)|SFI is a measure to quantify sleep restlessness. SFI calculated from analysis of the periods that participant was not moving (immobile bouts). It is number of immobile bouts that were exactly 1 minute long divided by total number of immobile bouts. Value ranges from 0-100 percent, with low number representing more restful sleep. SFI determined by actigraphy. Actigraphy was performed with an accelerometer that was worn on wrist like a watch. It was programmed to record movements while device was being worn. Endpoint was the last observation for a participant assessed using imputation method.|Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16, Endpoint (up to Week 16)|ITT population. N (number of participants analyzed) = participants evaluable for this measure. Missing data for endpoint (up to Week 16) imputed using LOCF. Data for Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16 were collected and reported in individual participant listings but not statistically summarized for analysis.||percentage of immobile bouts||Standard Error|Least Squares Mean
810157|NCT01049217|Secondary|Total Sleep Time (TST) and Minutes of Interrupted Sleep (MIS)|Total sleep time is the number of minutes asleep between time of sleep onset to morning awakening and MIS is the number of minutes spent awake after sleep onset to final awakening. TST and MIS were determined by actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to record movements while the device was being worn. Endpoint was the last observation for a participant assessed using specified imputation method.|Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16, Endpoint (up to Week 16)|ITT population. N (number of participants analyzed) = participants evaluable for this measure. Missing data for endpoint (up to Week 16) imputed using LOCF. Data for Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16 were collected and reported in individual participant listings but not statistically summarized for analysis.||minutes||Standard Error|Least Squares Mean
810201|NCT01049373|Secondary|Change in Strength of Pain (Visual Analog Scale VAS)||following 2 weeks treatment||||||
810731|NCT01048606|Primary|Markers of Oxidative Stress: Conjugated Diene Formation, Malondialdehyde, Alpha-tocopherol and Its Oxidised Form Alpha-tocopheryl Quinone. TAS Constitutes the Most Reliable Method for the Evaluation of Oxidative Stress in Vivo.||Baseline||||||
810158|NCT01049217|Secondary|Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Subscales and Total Intensity Score at Endpoint (up to Week 16)|NPSI: participant rated questionnaire to evaluate different symptoms of neuropathic pain (subscales: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. The relevant subscales and total score were transformed to 0-1, higher score indicates a greater intensity of pain. Endpoint=last observation for participant as per imputation method.|Baseline, Endpoint (up to Week 16)|ITT population: all randomized participants who took at least 1 dose of study drug. n = participants evaluable for this measure at specified time points for each arm group, respectively. Missing data for endpoint (up to Week 16) imputed using LOCF.||units on a scale||Standard Deviation|Mean
810159|NCT01049217|Secondary|Neuropathic Pain Symptom Inventory (NPSI): Change From Baseline in Number of Participants With Duration of Spontaneous Pain and Number of Pain Attacks at Endpoint (up to Week 16)|NPSI: participant-rated questionnaire to evaluate different symptoms of neuropathic pain. It includes 10 descriptors, and 2 temporal items. Results reported for categorical change in temporal items assessed on 5-point scale for duration of spontaneous pain (1=continuously, 2=8-12 hours [hrs], 3=4-7 hrs, 4=1-3 hrs, 5=less than 1 hr), numbers of pain attacks (1=more than 20, 2=11-20 attacks, 3=6-10 attacks, 4=1-5 attacks, 5=no attack). Change data categorized as worsened (negative change), unchanged (no change), and improved (positive change). Endpoint=last observation as per imputation method.|Baseline, Endpoint (up to Week 16)|ITT population: all randomized participants who took at least 1 dose of study drug. N (number of participants analyzed) signifies those participants who were evaluable for this measure. n = participants evaluable for this measure at specified time points for each arm group, respectively. Missing data for endpoint (up to Week 16) imputed using LOCF.||participants|||Number
810160|NCT01049217|Secondary|Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Item Scores at Endpoint (up to Week 16)|NPSI: participant-rated questionnaire to evaluate different symptoms of neuropathic pain. It includes 10 descriptors and 2 temporal items. Results reported for the 10 descriptors (burning, squeezing, pressure, electric shocks, stabbing, light touching of area, pressure of area, cold of area, pins and needles, tingling) quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) scale. Endpoint was the last observation for a participant assessed using specified imputation method.|Baseline, Endpoint (up to Week 16)|ITT population: all randomized participants who took at least 1 dose of study drug. n = participants evaluable for this measure at specified time points for each arm group, respectively. Missing data for endpoint (up to Week 16) imputed using LOCF.||units on a scale||Standard Deviation|Mean
810161|NCT01049217|Secondary|Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score at Week 4, 8, 12, 16 and Endpoint (up to Week 16)|BPI-sf:5-item self-administered questionnaire to assess severity,impact of pain on daily functions. Pain Severity Index (PSI):average of Question 1-4 each measured severity of pain over past 24-hours on 11-point scale (0=no pain to 10=worst possible pain). Pain Interference Index (PII):average of 7 pain interference items of Question 5 that measured level of interference of pain on daily function on 11-point scale (0=does not interfere to 10=completely interferes). For PSI, PII range:0-10 higher score=higher pain/interference. Endpoint=last observation for participant as per imputation method.|Baseline, Week 4, 8, 12, 16, Endpoint (up to Week 16)|ITT population: all randomized participants who took at least 1 dose of study drug. N (number of participants analyzed) signifies those participants who were evaluable for this measure. n = participants evaluable for this measure at specified time points for each arm group, respectively. Missing data for endpoint (up to Week 16) imputed using LOCF.||units on a scale||Standard Deviation|Mean
810162|NCT01049217|Secondary|Change From Baseline in Numeric Rating Scale (NRS)-Current Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and Endpoint (up to Week 16)|Weekly current pain score was defined as the mean of the daily current pain diary ratings split into 7 day intervals. Participants rated current (“right now”) HIV neuropathy pain an 11-point NRS ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. Endpoint was the last observation for a participant assessed using specified imputation method.|Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, Endpoint (up to Week 16)|ITT population: all randomized participants who took at least 1 dose of study drug. n = participants evaluable for this measure at specified time points for each arm group, respectively. Missing data for endpoint (up to Week 16) imputed using LOCF.||units on a scale||Standard Deviation|Mean
810163|NCT01049217|Secondary|Change From Baseline in Numeric Rating Scale (NRS)-Sleep Interference Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and Endpoint (up to Week 16)|Weekly mean sleep interference score was defined as the mean of the daily sleep interference diary ratings split into 7 day intervals. Participants rated how HIV neuropathy pain has interfered with their sleep during the past 24 hours on an 11-point NRS ranging from 0 = does not interfere with sleep to 10 = completely interferes (unable to sleep due to pain). Endpoint was the last observation for a participant assessed using specified imputation method.|Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, Endpoint (up to Week 16)|ITT population: all randomized participants who took at least 1 dose of study drug. N (number of participants analyzed) signifies those participants who were evaluable for this measure. n = participants evaluable for this measure at specified time points for each arm group, respectively. Missing data for endpoint (up to Week 16) imputed using LOCF.||units on a scale||Standard Deviation|Mean
810164|NCT01049217|Secondary|Number of Participants With Categorical Scores on Clinician Global Impression of Change (CGIC)|The CGIC scale measures a physician’s global impression of a participant’s clinical condition at final visit in terms of change relative to the start of treatment (CGIC). At final visit, the participants CGIC will be categorized into a three point scale as: improvement: CGI response of very much improved, much improved or minimally improved; no change: CGI response of no change; worsening: CGI response of very much worse, much worse or minimally worse. Number of participants in each category is reported.|Week 16|ITT population: all randomized participants who took at least 1 dose of study drug. N (number of participants analyzed) signifies those participants who were evaluable for this measure.||participants|||Number
810314|NCT01050790|Secondary|CTA Expression Before and After Azacitidine Therapy|Six patients tested have demonstrated CTA up-regulation in either unfractionated bone marrow (n = 4) or CD138+ cells (n = 2). CTA (CTAG1B)-specific T cell response has been observed in all three patients tested and persists following SCT.|3 months|||participants|||Number
810165|NCT01049217|Secondary|Number of Participants With Categorical Scores on Patient Global Impression of Change (PGIC)|PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Number of participants in each category is reported.|Week 16|ITT population: all randomized participants who took at least 1 dose of study drug. N (number of participants analyzed) signifies those participants who were evaluable for this measure.||participants|||Number
810166|NCT01049217|Primary|Change From Baseline in Mean Pain Score at Endpoint (up to Week 16)|Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their Human Immunodeficiency Virus (HIV) neuropathy pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. Endpoint was the last observation for a participant assessed using specified imputation method, modified Baseline Observation Carried Forward (mBOCF).|Baseline, Endpoint (up to Week 16)|Intent to Treat (ITT) population: all randomized participants who took at least 1 dose of study drug. Imputation: mBOCF, baseline data was carried forward for participants who discontinued due to adverse events or had no post-baseline observations; otherwise last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
810167|NCT01049243|Secondary|Change in Investigator Global Assessment of Atopic Dermatitis Severity From Baseline to Day 14.||Baseline to 14 days||||||
810168|NCT01049243|Primary|Change in Investigator Global Assessment of Atopic Dermatitis Severity From Baseline to Day 2/3.|Use of the Investigator's Global Assessment (IGA) score, a subjective scale measuring disease severity. Based on a 6-point scale from 0 (completely clear) to 5 (very severe). Defined score of 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe.|Baseline to 3 days|||Scores on a scale||Standard Deviation|Mean
810169|NCT01049308|Secondary|Medication Adherence|"To capture both overtaking and undertaking medication, a delta was determined for each medication by computing the absolute difference between the number of pills taken and the number prescribed over the 30-day period. The delta values for each medication were summed for each individual subject, divided by the total number of pills prescribed, subtracted from 1, and finally multiplied by 100 to obtain an adherence score expressed as a percentage."|30 days|||percentage of adherence||95% Confidence Interval|Mean
810170|NCT01049308|Primary|SLUMS Scores|SLUMS (Saint Louis University Mental Status) exam is a validated screening test for cognitive impairment (CI) consisting of 30-point interview scale. SLUMS is considered positive for mild CI if the score is <27 in a person with a high school diploma or <25 in a person who did not complete high school. SLUMS screening is considered positive for severe impairment consistent with dementia if the score is <21 for persons with a high school diploma and <20 for persons who did not complete high school.|baseline collection|||scores on a scale||Standard Deviation|Mean
810171|NCT01049334|Secondary|Kaplan-Meier Estimates for Sore Throat Pain Intensity Scale (STPIS) Time to Definite Improvement Duration of Relief Using Participant-Defined Definite Improvement Levels (DIL)|"As part of a protocol amendment, some participants defined a definite improvement level (DIL) relative to their actual pretreatment STPIS on the 100-mm visual analog scale. This was done after completing the 7 day trial.
The time of first achieving DIL for 30 minutes within 6 hours (or until rescue or re-dosing) post-dosing will be determined. And the time falling below DIL within 6 hours will be determined. Duration is then defined as the time from first DIL until falling below DIL. Duration was set to zero if the STPIS score does not reach the DIL for at least 30 minutes for STPIS during the 6 hours."|6 hours|Intent to treat population of participants who completed the Definite Improvement Level (DIL) following study completion.||minutes||Standard Deviation|Mean
810172|NCT01049334|Secondary|Kaplan-Meier Estimates for Sore Throat Pain Intensity Scale (STPIS) Time to Definite Improvement|"As part of a protocol amendment, some participants defined a definite improvement level (DIL) relative to their actual pretreatment STPIS on the 100-mm visual analog scale. This was done after completing the 7 day trial.
An alternative definition of STPIS time to onset of relief was the time from initial dose to the time the participant reaching DIL for at least 30 minutes. Data were censored if DIL was not achieved by 120 minutes following initial dose. Definite improvement must also occur prior to re-dosing or using rescue medication."|2 hours|Intent to treat population of participants who completed the Definite Improvement Level (DIL) following study completion.||minutes||95% Confidence Interval|Median
810173|NCT01049334|Secondary|Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) at Each Post-Dose Time Point Until the Time Point at Which Comparison of the Arms Yielded a P-value <=0.05|"Data reported in summary form in Primary Outcome #1 are reported here at each post-dose timepoint until the comparison resulted in a P-value <=0.05 between the two treatment arms.
STPIS was used to measure sore throat pain intensity using a 100-mm visual analog scale completed by participants that measures “pain on swallowing” (odynophagia). A mark at 0-mm indicates no pain and 100-mm indicates severe pain. The full range of the scale varies by timepoint due to the time weighting sum of SPID. The full scale at 40 minutes post dose was -3188 (complete pain relief within 2 minutes of dosing that lasts 40 minutes) to 812 (maximum pain within 2 minutes lasting 40 minutes) using the mean baseline STPIS.
If a participant used rescue medication (acetaminophen 650mg was allowed as needed), all post-rescue STPIS values in the 24-hour interval were assigned the baseline value for STPIS. Missing scores of STPIS with non-missing STPIS scores at earlier and later assessments (rec"|baseline (pre-dose), up to 23 hours post-dose (every 2 minutes for one hour; every 10 minutes until hour 2; every 30 minutes until hour 6; and every hour the participant was awake between hours 7-23)|Intent to treat population of participants who took the first full dose of medication.||units on a scale||Standard Deviation|Mean
810174|NCT01049334|Secondary|Sore Throat Relief Rating Scale (STRRS) At 2 Hours After Initial Dose|"Participants used a 6-category relief scale (no relief to complete relief) to grade the relief of his/her throat pain.
The patient was instructed to swallow and:
“Considering how your throat felt before you took the study medicine, circle the phrase that best describes the relief of your sore throat now.”"|2 hours|Intent to treat population of participants who had a 2 hour assessment.||percentage of participants|||Number
810202|NCT01049373|Secondary|"Change in Pain Score (SES), Subscale Sensoric Pain"|"Pain Perception Scale (SES) The SES is a patient questionnaire, which consists of 24 questions, both the affective (14 questions) and sensoric (10 questions) depict aspects.
Difference between screening and 15 weeks in the subscale sensoric pain Scale ranges from 10(=best) to 40(=worst)"|following 15 weeks treatment|Only patients with assessable values at present time point were analyzed.||units on a scale||Standard Deviation|Mean
810175|NCT01049334|Secondary|Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale Over 24 Hours Post-baseline (STPIS SPID24) For Participants With Baseline Practitioner’s Assessment of Pharyngeal Inflammation (PAIN) of Moderate or Severe|"STPIS measures sore throat pain intensity on a 100-mm visual analog scale completed by participants. A mark at 0-mm indicates no pain upon swallowing and 100-mm indicates severe pain. For the subgroup of patients with moderate/severe pharyngeal inflammation at baseline, SPID24 was calculated as the sum of the time weighted pain intensity differences from baseline until 24 hours. Taking inclusion criteria into account, the full range was -116196 (no pain at any post-dose time (0) – average baseline) to 27804 (maximum possible pain (100) – average baseline).
Participants with their last recorded time point <21 hours were considered Not Evaluable. If a participant used rescue medication (acetaminophen 650mg was allowed as needed), all post-rescue STPIS values in the 24-hour interval were assigned the baseline value for STPIS. Missing scores of STPIS with non-missing STPIS scores at earlier and later assessments were imputed using linear interpolation."|baseline (pre-dose), 24 hours post-dose (every 2 minutes for one hour; every 10 minutes until hour 2; every 30 minutes until hour 6; and every hour the participant was awake between hours 7-24)|Intent to treat population of participants who took the first full dose of medication and had moderate or severe pharyngeal inflammation at baseline.||units on a scale||Standard Deviation|Mean
810176|NCT01049334|Secondary|Investigators' Clinical Assessment (CLIN) Of Study Medication as a Treatment for Sore Throat at the End of the Study (Day 7)|"Investigators assessed the effectiveness of study medication on the patient's sore throat at the end of the study by answering the following question: Considering the patient's response to the study medicine over the past 7 days, how do you rate the study medicine as a treatment for sore throat? Responses were poor, fair, good, very good or excellent."|Day 7|Intent to treat population of participants who had an end of study assessment.||percentage of participants|||Number
810177|NCT01049334|Secondary|Participant Satisfaction Scores 24 Hours After Initial Dose|After 24 hours of treatment, participants rated their satisfaction with the treatment on a 7-step scale from extremely dissatisfied to extremely satisfied.|24 hours|Intent to treat population. Three participants withdrew before the 24 hour assessment.||percentage of participants|||Number
810178|NCT01049334|Secondary|Investigators’ Clinical Assessment (CLIN) Of Study Medication as a Treatment for Sore Throat at 24 Hours After Initial Dose|Investigators assessed the effectiveness of study medication on the patient’s sore throat at 24 hours following initial dose by answering the following question: “Considering the patient’s response to the study medicine over the past 24 hours, how do you rate the study medicine as a treatment for sore throat?” Responses were poor, fair, good, very good or excellent.|24 hours|Intent to treat population. Three participants withdrew before the 24 hour assessment.||percentage of participants|||Number
810179|NCT01049334|Secondary|Practitioner’s Assessment of Pharyngeal Inflammation (P.A.I.N.) Scores at 24 Hours After Initial Dose|P.A.I.N is a four step scale in which physicians rate the severity of pharyngeal inflammation: No inflammation, mild, moderate and severe inflammation.|24 hours post-dose|Intent to treat population. Three participants withdrew before the 24 hour assessment.||participants|||Number
810180|NCT01049334|Secondary|Change From Baseline at 24 Hours in the Tonsillo-Pharyngitis Assessment (TPA) Scores in Participants With Baseline TPA Scores >=8|"Tonsillo-Pharyngitis Assessment, or TPA, is an index of seven clinical features of the pain-producing condition itself, pharyngeal inflammation. The clinical features concern temperature, oropharyngeal color, size of tonsils, number of enanthems, largest size of cervical lymph node, number of lymph nodes, and maximum tenderness of lymph nodes. Each variable was rated on a scale of 0-3, with 0 representing the normal value, and 3 representing severe inflammation. The seven values are added together to create the TPA, ranging from 0-21.
Negative change values represent improvement of symptoms."|Baseline (pre-dose), 24 hours post-dose|Intent to treat population of participants whose baseline TPA was >=8 and had an assessment at hour 24.||units on a scale||Standard Deviation|Mean
810181|NCT01049334|Secondary|Time Weighted Summed Differences in Swollen Throat Scale (SwoTS) During the Initial 24 Hours From Baseline|"The participant was asked to evaluate how swollen his/her throat felt using a 100-mm visual analog scale at Baseline and specified timeframes until 24 hours.
The patient was instructed to swallow and “Place a line on the scale that best characterizes how swollen your throat feels now.” A mark at 0-mm indicated not swollen and 100-mm indicated very swollen. The full range of the sum of the time-weighted swollen throat differences from baseline until 24 hours was -112032 (throat did not feel swollen at all within 1 hour of dosing and lasted 24 hours) to 31968 (maximum swollen throat reported within 1 hour and lasting 24 hours) using the mean baseline SwoTS."|baseline (pre-dose), 24 hours post-dose (1 hour, 70 minutes, 80 minutes, 90 minutes, 100 minutes, 110 minutes, 2 hours, 2½ hours, 3 hours, 3½ hours, 4 hours, 4½ hours, 5 hours, 5½ hours, and 6 hours after the first dose, hourly from 7-24 hours)|Intent to treat population of participants who took the first full dose of medication, and had SwoTS recorded after 21 hours. Four participants (1 Flurbiprofen, 3 Vehicle) did not have SwoTS recorded after 21 hours and were not included in the analysis.||units on a scale||Standard Deviation|Mean
810182|NCT01049334|Secondary|Time Weighted Summed Differences in Swollen Throat Scale (SwoTS) During the Initial 2 Hours From Baseline|"The participant was asked to evaluate how swollen his/her throat felt using a 100-mm visual analog scale at Baseline and at 1 hour, 70 minutes, 80 minutes, 90 minutes, 100 minutes, 110 minutes, and 2 hours.
The patient was instructed to swallow and “Place a line on the scale that best characterizes how swollen your throat feels now.” A mark at 0-mm indicated not swollen and 100-mm indicated very swollen. The full range of the sum of the time-weighted swollen throat differences from baseline until 2 hours was -9336 (throat did not feel swollen at all within 1 hour of dosing and lasted 2 hours) to 2664 (maximum swollen throat reported within 1 hour and lasting 2 hours) using the mean baseline SwoTS."|baseline (pre-dose), 2 hours post-dose (at 1 hour, 70 minutes, 80 minutes, 90 minutes, 100 minutes, 110 minutes, and 2 hours)|Intent to treat population of participants who took the first full dose of medication.||units on a scale||Standard Deviation|Mean
810203|NCT01049373|Secondary|"Change in Pain Score (SES), Subscale Sensoric Pain"|"Pain Perception Scale (SES) The SES is a patient questionnaire, which consists of 24 questions, both the affective (14 questions) and sensoric (10 questions) depict aspects.
Difference between V1 minus V-1 in the subscale sensoric pain Scale ranges from 10(=best) to 40(=worst)"|following 2 weeks treatment|Only patients with assessable values at present time point were analyzed.||units on a scale||Standard Deviation|Mean
810183|NCT01049334|Secondary|Time Weighted Summed Differences in Difficulty Swallowing Scale (DSS) During the Initial 24 Hours From Baseline|"Participants were asked to evaluate his/her difficulty swallowing (dysphagia) using a 100-mm visual analog scale at Baseline and until 24 hours post dose.
Participants were instructed to swallow and Place a line on the scale that best characterizes how difficult it is to swallow now. A mark at 0-mm indicated no difficulty and 100-mm indicated very difficult. Data is reported as the sum of the time-weighted pain intensity differences from baseline until 24 hours post dose. The full range was -110304 (no difficulty swallowing within 10 minutes of dosing that lasts 24 hours) to 33696 (maximum difficulty swallowing within 10 minutes lasting 24 hours) using the baseline DSS value.
Missing values of DSS with non-missing values at assessments before and after were calculated using linear interpolation."|baseline (pre-dose), 24 hours post-dose (every 10 minutes until hour 2, every 30 minutes until hour 6, hourly from 7-24 hours)|Intent to treat population of participants who took the first full dose of medication and had DSS recorded after 21-hours.||units on a scale||Standard Deviation|Mean
810184|NCT01049334|Secondary|Time Weighted Summed Differences in Difficulty Swallowing Scale (DSS) During the Initial 2 Hours From Baseline|"Participants were asked to evaluate his/her difficulty swallowing (dysphagia) using a 100-mm visual analog scale at Baseline and 2 hours post dose.
Participants were instructed to swallow and Place a line on the scale that best characterizes how difficult it is to swallow now. A mark at 0-mm indicated no difficulty and 100-mm indicated very difficult. Data is reported as the sum of the time-weighted pain intensity differences from baseline until 2 hours post dose. The full range was -9192 (no difficulty swallowing within 10 minutes of dosing that lasts 2 hours) to 2808 (maximum difficulty swallowing within 10 minutes lasting 2 hours) using the baseline DSS value.
Missing values of DSS with non-missing values at assessments before and after were calculated using linear interpolation."|baseline (pre-dose), 2 hours post-dose (every 10 minutes until hour 2)|Intent to treat population of participants who took the first full dose of medication.||units on a scale||Standard Deviation|Mean
810185|NCT01049334|Secondary|Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) Over the 2 Hours Post-baseline (STPIS SPID2)|"STPIS measures sore throat pain intensity on a 100-mm visual analog scale completed by participants. A mark at 0-mm indicates no pain upon swallowing and 100-mm indicates severe pain. SPID2 was calculated as the sum of the time-weighted pain intensity differences from baseline until 2 hours post dosing. The full range was -9405 (complete pain relief within 2 minutes of dosing that lasts 2 hours) to 2395 (maximum pain within 2 minutes lasting 2 hours) using the mean baseline STPIS.
If a participant used rescue medication (acetaminophen 650mg was allowed as needed post dose), all post-rescue STPIS values in the 24-hour interval were assigned the baseline value for STPIS. Missing scores of STPIS with non-missing STPIS scores at earlier and later assessments (recorded or derived due to rescue) were imputed using linear interpolation assuming the time of the missing assessment to be the nominal time since initial dose."|baseline (pre-dose), 2 hours post-dose (every 2 minutes for one hour; every 10 minutes until hour 2)|Intent to treat population of participants who took the first full dose of medication.||units on a scale||Standard Deviation|Mean
810186|NCT01049334|Primary|Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) Over the 24 Hours Post-baseline (STPIS SPID24)|STPIS measures sore throat pain intensity on a 100-mm visual analog scale completed by participants. A mark at 0-mm indicates no pain upon swallowing and 100-mm indicates severe pain. SPID24 was calculated as the sum of the time-weighted pain intensity differences from baseline until 24 hours. The full range was -114609 (complete pain relief within 2 minutes of dosing that lasts 24 hours) to 29191 (maximum pain within 2 minutes lasting 24 hours) using the mean baseline STPIS. Participants with a last recorded time point <21 hours were considered Not Evaluable. If a participant used rescue medication, all post-rescue STPIS values in the 24-hour interval were assigned the baseline value for STPIS. Missing scores of STPIS with non-missing STPIS scores at earlier and later assessments were imputed using linear interpolation assuming the time of the missing assessment to be the nominal time since initial dose.|baseline (pre-dose), 24 hours post-dose (every 2 minutes for one hour; every 10 minutes until hour 2; every 30 minutes until hour 6; and every hour the participant was awake between hours 7-24)|Intent to treat population of participants who took the first full dose of medication. Three participants (1 Flurbiprofen, 2 Placebo) did not have sufficient 24 hour data to be included in the primary analysis of the primary endpoint (no entries after 2 hours), but did have sufficient data to be included in other efficacy analyses.||units on a scale||Standard Error|Least Squares Mean
810187|NCT01049360|Secondary|Change From Baseline in Morning Peak Forced Expiratory Volume in One Second (FEV1)||Day 14|ITT Population defined as randomized patients who took at least one dose of double-blind investigational product and who had at least 1 baseline and 1 post-baseline assessment of FEV1||Liters||Standard Error|Least Squares Mean
810188|NCT01049360|Secondary|Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1)||Day 14|ITT Population defined as randomized patients who took at least one dose of double-blind investigational product and who had at least 1 baseline and 1 post-baseline assessment of FEV1||Liters||Standard Error|Least Squares Mean
810189|NCT01049360|Primary|Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve Over 12 Hours (AUC0-12)||0 to 12 hours post-dose on Day 14|ITT Population defined as randomized patients who took at least one dose of double-blind investigational product and who had at least 1 baseline and 1 post-baseline assessment of FEV1||Liters||Standard Error|Least Squares Mean
810190|NCT01049373|Secondary|Number of ADRs|frequency of ADR with a probable or possible causal relationship|within 15 weeks treatment|||adverse reactions|||Number
810191|NCT01049373|Secondary|Number of Days With Incapability to Work||15 weeks treatment||||||
810192|NCT01049373|Secondary|Amount of Analgesics Used||15 weeks treatment||||||
810193|NCT01049373|Secondary|Correlation of Efficacy With the Constitutional Type of the Patient, Measured by the Hattinger Constitutional Manual (HKM) and the Hattinger Constitutional Questionnaire (HKF)||following 15 weeks treatment||||||
810194|NCT01049373|Secondary|Change in Short Form Health Survey 12 Items (SF-12) Ment||following 15 weeks treat||||||
810195|NCT01049373|Secondary|Change in Short Form Health Survey 12 Items (SF-12)||following 2 weeks treatment||||||
810196|NCT01049373|Secondary|Change in Oswestry Score||following 15 weeks treatment||||||
810197|NCT01049373|Secondary|Change in Oswestry Score||following 2 weeks treatment||||||
810198|NCT01049373|Secondary|Change in State of Health (BF-S)||following 15 weeks treatment||||||
810204|NCT01049373|Secondary|Change in FFbH-R Between Screening and 2 Weeks|"Hannover Functional Questionnaire (FFbH-R) As used in this study test FFbH-R is a special version of the FFbH for close to everyday diagnostics of functional impairment by back pain. It is a patient questionnaire, which consists of 12 questions for the acquisition of functional limitations consists in activities of daily living.
Change in FFbH-R between screening and 2 weeks Scale ranges from 0 (=worst) to 100(=best)"|between screening and 2 weeks treatment|ITT||units on a scale||Standard Deviation|Mean
810205|NCT01049373|Primary|Change in FFbH-R Between Screening and Week 15|"Hannover Functional Questionnaire (FFbH-R) As used in this study test FFbH-R is a special version of the FFbH for close to everyday diagnostics of functional impairment by back pain. It is a patient questionnaire, which consists of 12 questions for the acquisition of functional limitations consists in activities of daily living.
Change in FFbH-R between screening and week 15 Scale ranges from 0 (=worst) to 100(=best)"|between screening and 15 weeks treatment|ITT||units on a scale||Standard Deviation|Mean
810206|NCT01049503|Secondary|Caries Progression in Caries-inactive Children After 1 Year, According to the Type of Dentifrice Used|The lesions’ progression was evaluated by the data from the examinations at baseline and after 12 months. The lesions were considered to have progressed when a sound surface or inactive noncavitated (INC) caries lesion was reevaluated after 12 months as an ANC lesion or cavity (untreated cavity or filled tooth).|baseline and 12 months|The sample size was based on a previous trial (Lima et al., 2008). Accordingly, 24 children per dentifrice treatment resulted in a 85% power (α=0.05) for detecting difference of 0.23 and 0.65 in caries increment in the caries-inactive and caries-active groups, respectively. All the children that remained in the study after 12 months were analyzed.||progressed lesions/child||Standard Deviation|Mean
810207|NCT01049503|Secondary|Caries Progression in Caries-active Children After 1 Year, According to the Type of Dentifrice Used Assessed by the the Quantitative Light Induced Method (QLF) (Lesion Area (mm^2))|The white spot lesions' progression was also determined by the QLF in a subsample of 75 caries-active children. The images were captured from the deciduous teeth which had at least one smooth surface with a clinically visible ANC. For every lesion, the fluorescence change (∆F in %) and the area of the lesion (mm^2)(baseline – 12 months)were calculated by the software at the QLF threshold of 5%.|baseline and 12 months|The sample size was calculated according to Tranaeus et al. (2001). All the children that remained in the study after 12 months were analysed.||lesions/child||Standard Deviation|Mean
810208|NCT01049503|Secondary|Caries Progression in Caries-active Children After 1 Year, According to the Type of Dentifrice Used Assessed by the Quantitative Light Induced Method (QLF)(Fluorescence Change (∆F in %))|The white spot lesions' progression was also determined by the QLF in a subsample of 75 caries-active children. The images were captured from the deciduous teeth which had at least one smooth surface with a clinically visible ANC. For every lesion, the fluorescence change (∆F in %) and the area of the lesion (mm^2)(baseline – 12 months)were calculated by the software at the QLF threshold of 5%. A negative ∆F value indicates caries regression.|baseline and 12 months|The sample size was calculated according to Tranaeus et al. (2001). All the children that remained in the study after 12 months were analysed.||lesions/child||Standard Deviation|Mean
810209|NCT01049503|Primary|Evaluation of the Concentration of Fluoride Incorporated Into Participants' Toenails 6 Months After Initiation of the Dentifrices Use.|Samples of nails were analyzed for fluoride using an ion-specific electrode after diffusion with hexamethyldisiloxane-facilitated disiloxane (HMDS).|6 months|The sample size was calculated according to Buzalaf et al. (2009). From the trial participants in the fluoridated area, a convenience sample of 161 children was randomly selected. They were randomly divided (block allocation) into 3 groups, according to the type of liquid dentifrice they had been using for 6 months.||µgF/g||Standard Deviation|Mean
810210|NCT01049503|Secondary|Caries Regression in Caries-active Children After 1 Year, According to the Type of Dentifrice Used|The lesions’ progression or regression was evaluated by the data from the examinations at baseline and after 12 months. The net increment was calculated from the difference between lesions' progression and regression. The lesions were considered to have progressed when a sound surface or inactive noncavitated (INC) caries lesion was reevaluated after 12 months as an active noncavitated caries lesion (ANC) or cavity (untreated cavity or filled tooth). The lesions' regression was considered when an ANC lesion was reevaluated after 12 months as INC lesion or sound surface.|baseline and 12 months|The sample size was based on a previous trial (Lima et al., 2008). Accordingly, 24 children per dentifrice treatment resulted in a 85% power (α=0.05) for detecting difference of 0.23 and 0.65 in caries increment in the caries-inactive and caries-active groups, respectively. All the children that remained in the study after 12 months were analyzed.||regressed lesions/child||Standard Deviation|Mean
810211|NCT01049503|Secondary|Caries Progression in Caries-active Children After 1 Year, According to the Type of Dentifrice Used|The lesions' progression or regression was evaluated by the data from the examinations at baseline and after 12 months. The net increment was calculated from the difference between lesions' progression and regression. The lesions were considered to have progressed when a sound surface or inactive noncavitated (INC) caries lesion was reevaluated after 12 months as an active noncavitated caries lesion (ANC) or cavity (untreated cavity or filled tooth). The lesions' regression was considered when an ANC lesion was reevaluated after 12 months as INC lesion or sound surface.|baseline and 12 months|The sample size was based on a previous trial (Lima et al., 2008). Accordingly, 24 children per dentifrice treatment resulted in a 85% power (α=0.05) for detecting difference of 0.23 and 0.65 in caries increment in the caries-inactive and caries-active groups, respectively. All the children that remained in the study after 12 months were analyzed.||progressed lesions/child||Standard Deviation|Mean
810212|NCT01049503|Primary|Evaluation of the Concentration of Fluoride Incorporated Into the Biofilm Done 6 Months After Initiation of Dentifrices Use.|Samples of plaque were analyzed for fluoride using an ion-specific electrode after diffusion with hexamethyldisiloxane-facilitated disiloxane (HMDS).|6 months|The sample size was calculated according to Pessan et al. (2008). From the trial participants in the fluoridated area, a convenience sample of 47 children was randomly selected. They were randomly divided (block allocation) into 3 groups, according to the type of liquid dentifrice they had been using for 6 months.||mmol/kg||Standard Deviation|Mean
810264|NCT01050257|Secondary|Number of Participants With Viral Resistance|Nasal and Throat swabs were collected on Days 1, 4, 6, 11, 15 and 30 and were sent to a central laboratory for testing. Viral resistance was determined by phenotypic and genotypic testing.|30 days|Intent-to-Treat Infected population included all treated participants who had confirmed influenza infection by culture or RT-PCR.||Participants|||Number
810213|NCT01049581|Secondary|Subscale on Cerebral Palsy Quality of Life Questionnaire for Children|This questionnaire was developed for Children and was a condition-specific quality of life (QOL) questionnaire for children with cerebral palsy aged 4 to 12 years. It contains social , functioning, participation , emotional ,access, pain and disability, and family health components. Participation is the main component in this study. This sub score ranges from 0 to 81 , higher scores represent better participation|3months|||units on a scale||Standard Error|Mean
810214|NCT01049581|Secondary|Daily Living Subscale of Vineland Adaptive Behavior Scale|Vineland Adaptive Behavior scale was developed by Sara et al at 1984 and was used to measure adaptive and maladaptive behavior in children age form 3-12 years-old. The daily living subscale range from 0 to 198 and the higher the score represent the better captive behavior.|3 months|||units on a scale||Standard Deviation|Mean
810215|NCT01049581|Primary|Unit on Gross Motor Function Measure Scale (GMFM)|The GMFM is a standardized observational instrument designed and validated to measure change in gross motor function over time in children with cerebral palsy. The scoring key is meant to be a general guideline. However, most of the items have specific descriptors for each score. It is imperative that the guidelines contained in the manual be used for scoring each item. The score ranges from 0 to 100 and the higher represent the better gross motor function in children with cerebral palsy|3 months|complete the study and examination||units on a scale||Standard Deviation|Mean
810216|NCT01049776|Secondary|To Describe the Clinical Toxicity Profile of Pazopanib in This Particular Patient Population||after the first 6 patients and quarterly||||||
810217|NCT01049776|Primary|Proportion of Non Small Cell Lung Cancer Participants With Disease Control (Complete Response+Partial Response+Stable Disease) Based on RECIST 1.0 Measured by CT or MRI|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions: Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesion, taking as reference the baseline sum of the longest diameter: Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease, taking as reference the smallest sum Longest Diameter since the treatment started|12 weeks|||Proportion of participants||95% Confidence Interval|Number
810218|NCT01049802|Secondary|NIH Stroke Scale|"A composite scale derived from the Toronto Stroke Scale, the Oxbury Initial Severity Scale, the Cincinnati Stroke Scale and the Edinburgh-2 Coma Scale
15 items assessing severity of impairment in LOC, ability to respond to questions and obey simple commands, papillary response, deviation of gaze, extent of hemianopsia, facial palsy, resistance to gravity in the weaker limb, plantar reflexes, limb ataxia, sensory loss, visual neglect, dysarthria and aphasia severity
Items are graded on a 3 or 4 point ordinal scale; 0 equates no impairment
Scores range from 0 – 42. Higher scores indicate greater severity.
Stroke severity may be stratified on the basis of NIHSS scores as follows (Brott et al, 1989):
Very Severe: >25
Severe: 15 – 24
Mild to Moderately Severe: 5 – 14
Mild: 1 – 5"|Screening, baseline, post treatment, 1 month, 6 months|1 data point missing from treatment arm at 6 month||units on a scale||Standard Deviation|Mean
810219|NCT01049802|Secondary|Chedoke Arm Assessment|A 7 point scale of motor recovery scored separately for arm. 7 is good motor recovery and 1 is no movement.|Screening, baseline, weekly, post treatment, 1 month, 6 months|1 data point is missing in treatment arm at 6 month post||units on a scale||Standard Deviation|Mean
810220|NCT01049802|Secondary|Stroke Impact Scale|"The SIS is a quality of life questionnaire designed for stroke survivors. It is a 59 item measure
8 domains assessed:
Strength (4 items)
Hand function (5 items)
ADL/IADL (10 items)
Mobility (9 items)
Communication (7 items)
Emotion (9 items)
Memory and thinking (7 items)
Participation/Role function (8 items)
Each item is rated in a 5-point Likert scale in terms of the difficulty the patient has experienced in completing each item
Summative scores are generated for each domain, scores range from 0-100"|Baseline, post treatment, 1 month, 6 months|1 data point is missing from treatment arm a 6 months||units on a scale||Standard Deviation|Mean
810221|NCT01049802|Secondary|Action Research Arm Test|"The ARAT is a measure of upper limb dexterity and is a 19 item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point ordinal scale ranging from:
3: Performs test normally
2: Completes test, but takes abnormally long or has great difficulty
1: Performs test partially
0: Can perform no part of test Range is 0-57 with higher scores relating to better upper limb dexterity"|Baseline, post treatment, 1 month, 6 months|1 data point is missing from treatment arm at both 1 week and 6 month follow-up||units on a scale||Standard Deviation|Mean
810222|NCT01049802|Primary|Upper Extremity Fugl-Meyer Score|Upper extremity Fugl-Meyer Score measures of motor impairment in hemiplegic upper limb of patients with stroke. The scoring follows the natural progression of motor recovery as defined by Twitchell (Brain. 1951; 64:443-480). The score was developed by Axel Fugl-Meyer and it has been validated (Scand J Rehab Med. 1975; 7:13-31; Stroke. 2009; 40: 1386-1391). The scale ranges 0-66 with 66 representing normal motor function and 0 representing no movement. There are 33 movement items each scored 0 (cannot perform), 1 (peforms partially), 2 (performs flawlessly)|Baseline, post treatment, 1 month, 6 months|6 month outcome is the primary endpoint. 1 data point is missing from the treatment arm at 6 month follow up.||units on a scale||Standard Deviation|Mean
810223|NCT01049945|Secondary|Overall Survival (Phase II)||Up to 2 years from study completion (6 years total)||10/2016||||
810224|NCT01049945|Secondary|Progression Free Survival (Phase II)||Up to 2 years from study completion (6 years total)||10/2016||||
810225|NCT01049945|Secondary|Time to Progression (Phase II)||Up to 2 years from study completion (6 years total)||10/2016||||
810226|NCT01049945|Secondary|Duration of Response (Phase II)||Up to 2 years from study completion (6 years total)||10/2016||||
810265|NCT01050257|Secondary|Time to Resolution of Fever for Participants Who Had a Fever at Baseline|Fever was defined as a temperature of ≥ 37.8 C (degrees Celsius). Resolution of fever was a temperature ≤ 37.2 for at least 21.5 hours.|Baseline, Up to 30 Days|Participants from the Intent-to-Treat Infected population, all treated participants with confirmed influenza infection by culture or RT-PCR, who had a fever at Baseline.||Hours||95% Confidence Interval|Median
810266|NCT01050257|Secondary|Percentage of Participants Who Had a Fever During the Study|Fever was defined as a temperature of ≥ 37.8 C (degrees Celcius).|Baseline and Hours 12, 24, 36, 48, 60, 72, 84, 96 and 108|Intent-to-Treat Infected population included all treated participants who had confirmed influenza infection by culture or RT-PCR.||Percentage of participants|||Number
810227|NCT01049945|Primary|Confirmed Response Rate (Dose Level 4) Reported as the Percentage of Patients Achieving a Confirmed Response (sCR, CR, VGPR, or PR).|"Complete response (CR)
- Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow.
Stringent complete response (sCR) - A CR plus normal FLC ratio and no clonal cells in bone marrow
Near complete response (nCR) A CR, with the persistence of original monoclonal protein
Very good partial response (VGPR)
- Serum and urine M-component detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-component plus urine M-component <100 mg per 24 h
Partial response (PR)
≥50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥90% or to <200 mg per 24 h.
a ≥50% decrease in the difference between involved and uninvolved FLC levels
or a ≥50% reduction in plasma cells is required in place of M-protein, if ≥30% at baseline."|Up to 6 cycles of treatment|All participants registered to Dose Level 4 (the Maximum Tolerated Dose (MTD)) were eligible for the Phase II Primary Endpoint. This group included the 6 patients registered to Phase I, Dose Level 4 and the 49 participants registered to the Phase II portion.||percentage of participants||95% Confidence Interval|Number
810228|NCT01049945|Primary|Dose Limiting Toxicity of Bendamustine Hydrochloride and Lenalidomide in Combination With Dexamethasone (Phase I)|"The Maximum Tolerated Dose (MTD) is the dose level below that at which a dose limiting toxicity (DLT) is observed in ≥ 33% (i.e., ≥ 2 of 6) subjects in a cohort. A dose limiting toxicity is defined as one of the following adverse events in the Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 deemed at least possibly related to treatment:
Grade 2 neuropathy with pain
Any grade 3 Non-Hematologic toxicity
Any grade Non-Hematologic event requiring a dose reduction in cycle 1 or delaying the next cycle by >14 days.
Grade 4 neutropenia
Febrile neutropenia
Grade 4 thrombocytopenia
Grade 3 thrombocytopenia associated with bleeding
Any Hematologic event requiring a dose reduction in cycle 1 or a delay in the next cycle of treatment by >14 days.
We are reporting the results of this endpoint as the number of DLTs per dose level."|One cycle of treatment|All participants registered to the Phase I portion of this study were evaluable for this endpoint.||Dose Limiting Toxic Events|||Number
810229|NCT01049984|Secondary|Illness Severity Score at Day 0 and Week 18 As Assessed by the Site Rater|"Site raters were asked: Considering your total clinical experience with the particular population, how ill is the patient at this time? Answers were based on a 0-7 scale, with 0=not assessed, 1= normal, not at all ill, and 7= among the most extremely ill of patients.
Site raters can be the medical doctor [MD], doctor of osteopathy [DO], nurse practitioner, or physician assistant."|Day 0 (baseline), Week 18|Modified intent to treat||participants|||Number
810230|NCT01049984|Secondary|Clinical Global Improvement (CGI) Score at Week 18 As Assessed by the Participant|CGI is used by the participant to rate his/her total improvement during the study. Specifically, participants are asked to compare their condition at the beginning of the study to his/her condition at Week 18, how much has he/she changed? Answers are 0 (not assessed), 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse), 7(very much worse).|18 weeks|Modified intent to treat||participants|||Number
810231|NCT01049984|Secondary|Clinical Global Improvement (CGI) Score at Week 18 As Assessed by the Site Rater|"CGI is used by the site rater to rate participants total improvement during the study whether or not, in the investigators' judgment, it is due entirely to drug treatment. Specifically, site raters are asked to compare the participants condition at the beginning of the study to his/her condition at Week 18, how much has he/she changed? Answers are 0 (not assessed), 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse), 7(very much worse).
Site raters can be the medical doctor [MD], doctor of osteopathy [DO], nurse practitioner, or physician assistant."|18 weeks|Modified intent to treat||participants|||Number
810232|NCT01049984|Secondary|Change From Baseline to Week 18 in the Unified Parkinson’s Disease Rating Scale (UPDRS) Total Score for Part III – Motor Function|"The UPDRS was developed as a comprehensive tool to monitor the impact of Parkinson's Disease and the degree of disability caused. Version 3 of UPDRS contains four parts, the third of which is reported in this outcome. Part III is a clinician's evaluation of motor function. Part III contains 14 questions, which are each rated on a scale of 0 (normal or no disease effect) to 4 (maximum negative effect), for a total scale of 0-56. Negative change from baseline values indicate improvement.
All site raters (medical doctor [MD], doctor of osteopathy [DO], nurse practitioner, or physician assistant) received training on how to complete the UPDRS. The same site rater completed the UPDRS at all visits"|Day 0 (baseline), Week 18|Modified intent to treat population - all randomized participants who took at least 1 dose of study drug and had both a baseline and at least 1 post-baseline efficacy assessment. Several participants had missing UPDRS items at baseline and during treatment for subscale III, and therefore that subscale was set as missing.||units on a scale||Standard Error|Least Squares Mean
810233|NCT01049984|Secondary|Change From Baseline to Week 18 in the Unified Parkinson’s Disease Rating Scale (UPDRS) Total Score for Part II – Activities of Daily Living|The UPDRS was developed as a comprehensive tool to monitor the impact of Parkinson's Disease and the degree of disability caused. UPDRS contains four parts, the second of which is reported in this outcome. Part II is the participants' evaluation of the disease's impact on normal activities. Part II contains a total of 13 questions, which are each rated on a scale of 0 (normal or no disease effect) to 4 (maximum negative effect), for a total scale of 0-52. Negative change from baseline values indicate improvement.|Day 0 (baseline), Week 18|Modified intent to treat population - all randomized participants who took at least 1 dose of study drug and had both a baseline and at least 1 post-baseline efficacy assessment. Several participants had missing UPDRS items at baseline and during treatment for subscale II, and therefore that subscale was set as missing.||units on a scale||Standard Error|Least Squares Mean
810267|NCT01050257|Secondary|Change From Baseline in Influenza Titer by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) at Day 4|Nasal and throat swabs were collected at Baseline and Day 4 and were sent to a central laboratory for analysis. Influenza Viral titers (amount of virus present) were determined by RT-PCR for Flu A and Flu B and were reported in log 10 copies/milliliter (mL). A negative change from Baseline indicated improvement (less virus present).|Baseline, Day 4|Participants from the Intent-to-Treat Infected population with data available for analysis. Only participants with positive influenza results are included.||log 10 copies/mL||Standard Deviation|Mean
810315|NCT01050790|Secondary|Pre- and Post-ALI Immune Response to Cancer Testis Antigens (CTA)|Not able to obtain outcome data.|6 months|Not able to obtain outcome data. The lab doing this correlative analysis lost the personnel support to process the samples.|||||
810234|NCT01049984|Primary|Change From Baseline to Week 18 in the Unified Parkinson’s Disease Rating Scale (UPDRS) Total Score for Parts I, II and III|"The UPDRS was developed as a comprehensive tool to monitor the impact of Parkinson’s Disease and the degree of disability caused. Version 3 of UPDRS contains four parts, three of which are totaled and reported in this outcome. Part I is a clinician's evaluation of mentation (mental activity or state of mind), cognition (ability to acquire knowledge), behaviour and mood. Part II is the participants' evaluation of the disease's impact on normal activities. Part III is a clinician's evaluation of motor function. Parts I, II, and III contain a total of 31 questions, which are each rated on a scale of 0 (normal or no disease effect) to 4 (maximum negative effect), for a total scale of 0-124. Negative change from baseline values indicate improvement.
All site raters (medical doctor [MD], doctor of osteopathy [DO], nurse practitioner, or physician assistant) received training on how to complete the UPDRS. The same site rater completed the UPDRS at all visits."|Day 0 (baseline), Week 18|Modified intent to treat population - all randomized participants who took at least 1 dose of study drug and had both a baseline and at least 1 post-baseline efficacy assessment. Several participants had missing UPDRS items at baseline and during treatment; therefore the total UPDRS for these participants was set as missing.||units on a scale||Standard Error|Least Squares Mean
810235|NCT01050062|Secondary|Blood Pressure Normalised Rate|The proportion of the patients with normalized blood pressure in 52 weeks on administrative period. Normalized blood pressure is defined less than 140/90 (SBP/DBP) mmHg according to JSH2009|Week 52|The 13 patients which no efficacy information, were excluding from safety set, 1412 patients were included in efficacy set.||percentage of participants|||Number
810236|NCT01050062|Secondary|Target Blood Pressure Achievement Rate|The proportion of the patients with target blood pressure in 52 weeks administrative period. Target blood pressure is defined as 'Guidelines for the management of hypertension (JSH2009)': less than 140/90 (SBP/DBP) mmHg for >= 65 years old or cerebrovascular disorder patient; less than 130/80 in diabetes, chronic kidney disease or myocardial infarction patient; less than 130/85 mmHg for others patient.|Week 52|The 13 patients which no efficacy information, were excluding from safety set, 1412 patients were included in efficacy set.||Percentage of patients|||Number
810237|NCT01050062|Secondary|Diastolic Blood Pressure (DBP)|DBP is observed at Week 0 and Week 52. The change of DBP from Week 0 to Week 52 is calculated.|Week 0 and Week 52|The 13 patients which no efficacy information, were excluding from safety set, 1412 patients were included in efficacy set.||mmHg||Standard Deviation|Mean
810238|NCT01050062|Secondary|Systolic Blood Pressure (SBP)|SBP is observed at Week 0 and Week 52. The change of SBP from Week 0 to Week 52 is calculated.|Week 0 and Week 52|The 13 patients which no efficacy information, were excluding from safety set, 1412 patients were included in efficacy set.||mmHg||Standard Deviation|Mean
810239|NCT01050062|Primary|Incidence of Adverse Events (AEs)|The number of patient with any AEs, patients with drug-related AEs|Week 52|The all treated patients, 18 patients which were no information including safety due to no visit after enrolled. Then, total 1425 patients were observed in the survey||Patients|||Number
810240|NCT01050153|Secondary|Conventional Coagulation Testing Parameters|Plasma based conventional coagulation testing parameters - Protein C|Study day five.|||percentage of activity||Standard Error|Mean
810241|NCT01050153|Secondary|Conventional Coagulation Testing Parameters|Plasma based conventional coagulation testing parameters - Anti-thrombin III|Study day five.|||percentage of activity||Standard Error|Mean
810242|NCT01050153|Secondary|Conventional Coagulation Testing Parameters|Plasma based conventional coagulation testing parameters - Fibrinogen|Study day five.|||mg/dL||Standard Error|Mean
810243|NCT01050153|Secondary|Conventional Coagulation Testing Parameters|Plasma based conventional coagulation testing parameters - Anti Xa|Study day five.|||IU/mL||Standard Error|Mean
810244|NCT01050153|Secondary|TEG Parameters|"Shear elastic modulus strength (SEMS). The MA parameter can be transformed into the actual measure of clot strength (G) using the formula below, and is measured in dyn/cm2 divided by 1000 (displayed in the software as Kd/sc).
The absolute SEMS of the sample can be calculated from MA as follows:
G = (5000MA/(100-MA))/1000 An amplitude of 50 mm corresponds to a SEMS of 5000 dyn/cm2. An increase in MA from 50 mm to 67 mm is equivalent to a two-fold increase in the SEMS. The G parameter not only provides a measurement of clot firmness in force units, but also is more indicative of small changes in the clot strength or clot breakdown than is the amplitude in mm because it is an exponential reflection of MA."|Study day five.|||Kd/sc||Standard Error|Mean
810245|NCT01050153|Secondary|Platelet Count|Platelet count measured by CBC test|Study day five.|||* 10^3 platelets/µL||Standard Deviation|Mean
810246|NCT01050153|Secondary|International Normalized Ratio (INR)|Plasma based conventional coagulation testing parameters|Study day five.|||ratio||Standard Error|Mean
810247|NCT01050153|Secondary|TEG Parameters|"R is a reaction time. The time from the start of a sample run until the first significant levels of detectable clot formation (amplitude = 2 mm in the TEG tracing).
Rf is a difference in reaction time between Fragmin-active and Fragmin-neutralized samples.
Achievement of a certain clot strength K is a measure of the time from R until a fixed level of clot strength is reached (amplitude = 20 mm).
Angle or α measures the rapidity of fibrin build-up and cross-linking (clot strengthening). This most represents fibrinogen level. Angle relates to K, since both are a function of the rate of clot formation.
MA, or Maximum Amplitude, is a direct function of the maximum clot strength. In tests where platelets are part of the clot, this parameter most reflects platelet function/aggregation. Clot strength is the result of two components - the modest contribution of fibrin and the much more significant contribution of the platelets."|Study day five.|||Minutes||Standard Error|Mean
810248|NCT01050153|Primary|Incidence of VTE|The incidence and nature of hypercoagulability and the incidence of deep vein thrombosis and pulmonary embolism in each randomized group and in the subgroup receiving anti-platelet therapy in addition to Fragmin (descriptive analysis only)|Day 28 or discharge, whichever comes first.|||participants|||Number
810249|NCT01050153|Primary|Hypercoagulability|To determine the incidence of, and to characterize, hypercoagulability in a sample of trauma patients admitted to the SICU at DHMC using TEG and conventional clinical coagulation testing (APTT, INR), antithrombin III levels and protein C activity. Hypercoagulability is defined as TEG parameter G (clot strength) >10.9.|Study day five.|The reason for having 21 participants in the Control group and 18 participants in the TEG-guided group is that 21 and 18 participants in the respective groups stayed five days or longer. Four participants (25-21) in the Control group and seven participants (25-18) in the TEG-guided group stayed less than five days.||participants|||Number
810250|NCT01050205|Secondary|Changes in Diastolic Blood Pressure (BP) Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.|Blood pressure was measured in the right arm with the participant seated comfortably with the right arm resting on a table. All participants were asked to rest quietly with feet flat on the floor for five minutes. Following the five minute wait, the radial pulse was measured in the right arm and pulse obliteration level was assessed. The cuff was inflated to the peak inflation rate and the pressure released at a rate of 2mm/Hg per second. First appearance and last heard (phase V) Korotkoff’s sounds were utilized to determine systolic and diastolic blood pressure respectively. The cuffed arm was then raised for 5 seconds after each inflation with a wait period of 30 seconds between each blood pressure reading. Blood pressure was repeated twice with the average computed. If it was not possible to measure blood pressure in the right arm, the left arm was utilized and noted in the participant record.|Baseline and post-intervention (assessed at 6 months after commencement of intervention)|Intent to treat using last observation carried forward when data are missing. Individuals with medication changes related to the outcome were excluded from analysis.||mmHg||Standard Deviation|Mean
810251|NCT01050205|Secondary|Changes in Self-reported Physical Activity Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.|The Modifiable Activity Questionnaire (MAQ) was designed by Dr. Kriska. It has been used to assess activity in a variety of populations and age groups over various time frames and was used to assess physical activity levels in the DPP. The MAQ includes both a leisure and an occupational activity section since the homogeneity of energy expenditure related to both of these components of activity within many study populations cannot be assumed. In addition, the MAQ was designed to be modified, based upon pilot testing, prior to its usage, in order to maximize the feasibility and appropriateness of the physical activity instrument to the population of interest. The MAQ has been shown to be both reliable and valid (through comparisons with activity monitors, fitness (field) testing, and the doubly labeled water technique) in adults and adolescents alike. The MAQ has been used to assess a variety of time frames from past year and past week to a lifetime of activity.|Baseline and post-intervention (assessed at 6 months after commencement of intervention)|Intent to treat using last observation carried forward when data are missing.||MET-hrs leisure activity||Inter-Quartile Range|Median
810252|NCT01050205|Secondary|Changes in Waist Circumference Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.|The participant was asked stand with feet together. The waist was measured using a cloth measuring tape around the abdomen. The midpoints were marked horizontally at midpoint between highest point of the iliac crest and lowest part of the costal margin in the mid-axillary line. Both sides of the waist were marked using a cosmetic pencil. The participant was asked to have arms at side and to breathe in, out and hold, and then the measurement was taken. Waist measurement was recorded to the nearest quarter inch. The measure was repeated twice. If waist measures differ by more than one-half inch, a third measurement was recorded.|Baseline and post-intervention (assessed at 6 months after commencement of intervention)|Intent to treat using last observation carried forward when data are missing.||inches||Standard Deviation|Mean
810253|NCT01050205|Secondary|Changes in Systolic Blood Pressure (BP) Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.|Blood pressure was measured in the right arm with the participant seated comfortably with the right arm resting on a table. All participants were asked to rest quietly with feet flat on the floor for five minutes. Following the five minute wait, the radial pulse was measured in the right arm and pulse obliteration level was assessed. The cuff was inflated to the peak inflation rate and the pressure released at a rate of 2mm/Hg per second. First appearance and last heard (phase V) Korotkoff’s sounds were utilized to determine systolic and diastolic blood pressure respectively. The cuffed arm was then raised for 5 seconds after each inflation with a wait period of 30 seconds between each blood pressure reading. Blood pressure was repeated twice with the average computed. If it was not possible to measure blood pressure in the right arm, the left arm was utilized and noted in the participant record.|Baseline and post-intervention (assessed at 6 months after commencement of intervention)|Intent to treat using last observation carried forward when data are missing. Individuals with medication changes related to the outcome were excluded from analysis.||mmHg||Standard Deviation|Mean
810254|NCT01050205|Secondary|Changes in A1c Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.|Venous blood draw: After the participant signed the consent, they were taken to the private phlebotomy area. The participant sat in a stationary chair and placed their arm of choice for the blood draw flat on the table, on top of the BloodBloc pad. The participant was asked the last time they had anything to eat or drink, including candy, mint, gum, cough drops, cough syrup, coffee or tea, (participants were expected to fast for 8-12 hours prior to their assessment visit). If the participant had anything to eat or drink, other than water, the blood draw was rescheduled. The fasting blood sample was analyzed by Quest Diagnostics™ laboratory for the worksite and community/senior centers. A1c is a measure of glucose control over approximately an 8 to 12 week period.|Baseline and post-intervention (assessed at 6 months after commencement of intervention)|Intent to treat using last observation carried forward when data are missing. Individuals with medication changes related to the outcome were excluded from analysis.||percentage of glycosylated hemoglobin||Standard Deviation|Mean
810255|NCT01050205|Secondary|Changes in Fasting Lipids (LDL Cholesterol) Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.|Venous blood draw: After the participant signed the consent, they were taken to the private phlebotomy area. The participant sat in a stationary chair and placed their arm of choice for the blood draw flat on the table, on top of the BloodBloc pad. The participant was asked the last time they had anything to eat or drink, including candy, mint, gum, cough drops, cough syrup, coffee or tea, (participants were expected to fast for 8-12 hours prior to their assessment visit). If the participant had anything to eat or drink, other than water, the blood draw was rescheduled. The fasting blood sample was analyzed by Quest Diagnostics™ laboratory for the worksite and community/senior centers.|Baseline and post-intervention (assessed at 6 months after commencement of intervention)|Intent to treat using last observation carried forward when data are missing. Individuals with medication changes related to the outcome were excluded from analysis.||mg/dl||Standard Deviation|Mean
810256|NCT01050205|Secondary|Changes in Fasting Lipids (HDL Cholesterol) Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.|Venous blood draw: After the participant signed the consent, they were taken to the private phlebotomy area. The participant sat in a stationary chair and placed their arm of choice for the blood draw flat on the table, on top of the BloodBloc pad. The participant was asked the last time they had anything to eat or drink, including candy, mint, gum, cough drops, cough syrup, coffee or tea, (participants were expected to fast for 8-12 hours prior to their assessment visit). If the participant had anything to eat or drink, other than water, the blood draw was rescheduled. The fasting blood sample was analyzed by Quest Diagnostics™ laboratory for the worksite and community/senior centers.|Baseline and post-intervention (assessed at 6 months after commencement of intervention)|Intent to treat using last observation carried forward when data are missing. Individuals with medication changes related to the outcome were excluded from analysis.||mg/dl||Standard Deviation|Mean
810257|NCT01050205|Secondary|Changes in Fasting Lipids (Triglycerides) Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.|Venous blood draw: After the participant signed the consent, they were taken to the private phlebotomy area. The participant sat in a stationary chair and placed their arm of choice for the blood draw flat on the table, on top of the BloodBloc pad. The participant was asked the last time they had anything to eat or drink, including candy, mint, gum, cough drops, cough syrup, coffee or tea, (participants were expected to fast for 8-12 hours prior to their assessment visit). If the participant had anything to eat or drink, other than water, the blood draw was rescheduled. The fasting blood sample was analyzed by Quest Diagnostics™ laboratory for the worksite and community/senior centers.|Baseline and post-intervention (assessed at 6 months after commencement of intervention)|Intent to treat using last observation carried forward when data are missing. Individuals with medication changes related to the outcome were excluded from analysis.||mg/dl||Inter-Quartile Range|Median
810258|NCT01050205|Secondary|Changes in Fasting Lipids (Total Cholesterol) Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.|Venous blood draw: After the participant signed the consent, they were taken to the private phlebotomy area. The participant sat in a stationary chair and placed their arm of choice for the blood draw flat on the table, on top of the BloodBloc pad. The participant was asked the last time they had anything to eat or drink, including candy, mint, gum, cough drops, cough syrup, coffee or tea, (participants were expected to fast for 8-12 hours prior to their assessment visit). If the participant had anything to eat or drink, other than water, the blood draw was rescheduled. The fasting blood sample was analyzed by Quest Diagnostics™ laboratory for the work site and community/senior centers.|Baseline and post-intervention (assessed at 6 months after commencement of intervention)|Intent to treat using last observation carried forward when data are missing. Individuals with medication changes related to the outcome were excluded from analysis.||mg/dl||Standard Deviation|Mean
810259|NCT01050205|Secondary|Changes in Fasting Insulin Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.|Venous blood draw: After the participant signed the consent, they were taken to the private phlebotomy area. The participant sat in a stationary chair and placed their arm of choice for the blood draw flat on the table, on top of the BloodBloc pad. The participant was asked the last time they had anything to eat or drink, including candy, mint, gum, cough drops, cough syrup, coffee or tea, (participants were expected to fast for 8-12 hours prior to their assessment visit). If the participant had anything to eat or drink, other than water, the blood draw was rescheduled. The fasting blood sample was analyzed by Quest Diagnostics™ laboratory for the worksite and community/senior centers.|Baseline and post-intervention (assessed at 6 months after commencement of intervention)|Intent to treat using last observation carried forward when data are missing. Individuals with medication changes related to the outcome were excluded from analysis.||mg/dl||Standard Deviation|Mean
810260|NCT01050205|Secondary|Changes in Fasting Glucose Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.|After the participant signed the consent, they were taken to the private phlebotomy area. The participant sat in a stationary chair and placed their arm of choice for the blood draw flat on the table, on top of the BloodBloc pad. The participant was asked the last time they had anything to eat or drink, including candy, mint, gum, cough drops, cough syrup, coffee or tea, (participants were expected to fast for 8-12 hours prior to their assessment visit). If the participant had anything to eat or drink, other than water, the blood draw was rescheduled. The fasting blood sample was analyzed by Quest Diagnostics™ laboratory for the worksite and community/senior centers.|Baseline and post-intervention (assessed at 6 months after commencement of intervention)|Intent to treat using last observation carried forward when data are missing. Individuals with medication changes related to the outcome were excluded from analysis.||mg/dl||Standard Deviation|Mean
810261|NCT01050205|Primary|Changes in Weight Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.|Weight was measured twice using a digital physician’s scale (DETECTO® PD100) placed on a hard, flat surface. Participants were asked to remove their shoes and stand in the middle of the scale with eyes straight forward and without touching any surface. The participant was asked to step down from the scale between measures. If the measures were more than 0.5 pounds apart, a third measure was taken. Weight is reported in pounds.|Baseline and post-intervention (assessed at 6 months after commencement of intervention)|Intent to treat using last observation carried forward when data are missing.||Pounds||Standard Deviation|Mean
810262|NCT01050218|Primary|Change From Baseline in Mean Pain Score on the Numeric Rating Scale (NRS).|The primary efficacy variable was the pain severity score measured on an 11 point NRS on which 0=no pain and 10=worst possible pain. The primary efficacy evaluation was the change from baseline in mean pain score on the NRS.|Baseline and 9 months|The efficacy population was the intent-to-treat (ITT). This included all randomized subjects who had a baseline primary efficacy evaluation, had taken at least 1 dose of test article, and had at least 1 primary efficacy evaluation (ie, at least 1 NRS daily pain score) after the first dose of test article. No participants met that criterion.||units on scale|||Number
810263|NCT01050257|Secondary|Percentage of Participants With Influenza Symptoms|Influenza (flu) symptoms were nasal congestion, sore throat, cough, aches and pains, fatigue, headache or chills.|Days 1, 11, 15, 30|Intent-to-Treat population included all treated participants.||Percentage of participants|||Number
810268|NCT01050257|Secondary|Change From Baseline in Influenza Titer by Culture at Day 4|Nasal and throat swabs collected at Baseline and Day 4 were sent to a laboratory for analysis. Viral influenza titer (amount of virus present) was determined by culture. A log 10 median tissue culture infective dose (TCID50) > 0.5= Positive culture. A negative change from Baseline indicated improvement (less virus present).|Baseline, Day 4|Participants from the Intent-to-treat Influenza Infected population with data available for analysis. Only participants with positive influenza results are included.||log10 TCID50||Standard Deviation|Mean
810269|NCT01050257|Secondary|Percentage of Participants With Viral Shedding by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)|Nasal and throat swabs were collected on Days 1, 4, 6, 11, 15, and 30 and were sent to a central laboratory for analysis. The presence of viral shedding was determined by detection by RT-PCR (log 10 copies/mL).|Days 1, 4, 6, 11, 15 and 30|Intent-to-Treat Infected population included all treated participants who had confirmed influenza infection by culture or RT-PCR.||Percentage of participants|||Number
810270|NCT01050257|Secondary|Percentage of Participants With Viral Shedding by Culture|Nasal and throat swabs were collected on Days 1, 4, 6, 11, 15, and 30 and were sent to a central laboratory for analysis. The presence of viral shedding was determined by a positive culture=log10 median tissue culture infective dose (TCID50) > 0.5.|Days 1, 4, 6, 11, 15, 30|Intent-to-Treat Infected population included all treated participants who had confirmed influenza infection by culture or RT-PCR.||Percentage of participants|||Number
810271|NCT01050257|Secondary|Percentage of Participants With Viral Shedding by Culture or RT-PCR|Nasal and throat swabs were collected on Days 1, 4, 6, 11, 15, and 30 and were sent to a central laboratory for analysis. The presence of viral shedding was determined by a positive culture [log10 median tissue culture infective dose (TCID50) > 0.5) or detection by RT-PCR (log 10 copies/mL).|Days 1, 4, 6, 11, 15 and 30|Intent-to-Treat Infected population included all treated participants who had confirmed influenza infection by culture or RT-PCR.||Percentage of participants|||Number
810272|NCT01050257|Secondary|Pharmacokinetics||Days 1, 3||12/2013||||
810273|NCT01050257|Primary|Number of Participants With Adverse Events (AEs), Serious Adverse Events(SAEs, AEs Leading to Withdrawal, and Death|"Safety was assessed by adverse events (AEs) as measured by the collection of AEs, vital signs, electrocardiograms and laboratory parameters. An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events. A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
On treatment = AEs that started between the day of first dose and within 2 days after the last dose. Off treatment = AEs that started more than 2 days after the last dose of study drug."|Up to 30 days|Safety population included all participants who received treatment and had at least one post-treatment safety assessment. One patient in the 100 mg group actually received 200 mg and is included in the 200 mg group for safety.||Partipants|||Number
810274|NCT01050530|Secondary|Ascites Volume|Change in ascites volume from baseline as measured by CT at end of treatment|Baseline, Day 7 or at the discontinued of treatment|Full Analysis Set; LOCF||mL||Standard Deviation|Mean
810275|NCT01050530|Primary|Body ｗeight|Change in body weight from baseline after 7-day repeated oral administration of OPC|Baseline, Day 7 or at the discontinued of treatment|Full Analysis Set; LOCF||Kg||Standard Deviation|Mean
810276|NCT01050543|Primary|Time From Start of Study Drug Administration to Recovery of the T4/T1 Ratio to 0.9|Neuromuscular functioning was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 & T4 refer to the magnitudes (height) of the 1st & 4th twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from neuromuscular blockade. In this study, twitch responses were recorded until the T4/T1 Ratio reached >= 0.9, the minimum acceptable ratio that indicated complete recovery.|From Start of Study Drug Administration to Recovery of the T4/T1 Ratio to 0.9 (estimated from 2 minutes up to ~15 minutes)|Full Analysis Set, defined as all participants who received randomized treatment and had at least one efficacy measurement.||minutes||95% Confidence Interval|Geometric Mean
810277|NCT01050569|Secondary|Time to Lapse or Relapse to Tobacco Use||26 weeks|||weeks||95% Confidence Interval|Median
810278|NCT01050569|Secondary|Exposure to Tobacco Toxicants||6 weeks|||pmol/mg creatinine||95% Confidence Interval|Geometric Mean
810279|NCT01050569|Primary|End of Follow-up Abstinence Rates|CO- and cotinine-verified point prevalence abstinence|36 weeks|||participants|||Number
810280|NCT01050569|Primary|End of Treatment Abstinence Rate|Cotinine and carbon monoxide (CO) verified point prevalence abstinence|12 week|||participants|||Number
810281|NCT01050582|Secondary|Number of Participants With Retrospectively Reported Potentially Prolactin-Related Adverse Events|Previous potentially prolactin-related adverse events, including hyperprolactinemia, were reviewed and abstracted from participants' medical records. Potentially prolactin-related adverse events include breast symptoms, menstrual disorders, hyperprolactinemia, and prolactinoma.|Retrospectively during the time of exposure for up to 2 years prior to the study visit|||participants|||Number
810282|NCT01050582|Secondary|Age (Years) at Current Tanner Stage|Tanner stage is an evaluation of pubertal development with values ranging from 1 (pre-pubertal) to 5 (adult). A standardized, validated tool containing standardized pictures and written descriptions of the stages of pubic hair development, breast development for girls, and genital development for boys was used by physicians to make their assessment.|One single study visit, approximately one week after informed consent has been obtained|Participants with a physician assessed Tanner stage value.||years||Standard Deviation|Mean
810283|NCT01050582|Primary|Height (cm) Z-score at Study Visit|Height (cm) measured at the study visit was converted to a Z-score based on the US Center for Disease Control 2000 growth charts for US subjects and European growth charts for ex-US subjects. A z-score indicates how many standard deviations a subject is away from the expected height for the subject's age and gender.|One single study visit, approximately one week after informed consent has been obtained|All participants with a height assessment available at the study visit.||z-score||Standard Deviation|Mean
810732|NCT01048606|Primary|Glucose Metabolism: 2h-75g Oral Glucose Tolerance Test (OGTT) + Plasma Insulin and Glucose Concentrations (Blood Sample Analysis).||Baseline||||||
810284|NCT01050634|Primary|Change From Baseline in IBCSG Vaginal Symptoms - QoL Module 24-26|The 3 LASA items concerning vaginal symptoms (discharge, dryness, itching/irritation) were combined as the sum of these 3 items. Lower scores corresponded to better QoL, with negative changes from baseline corresponding to improvements in vaginal symptoms. Total overall score range=0-300, Best score=0, Worst score=300|Baseline, Month 12|FAS. Missing values were imputed by LOCF. Number of participants analyzed=Number of subjects with Baseline and Final Visit (LOCF) Scores.||Scores on a scale (mm)||Standard Deviation|Mean
810285|NCT01050634|Primary|Change From Baseline in 12-Item Short Form Health Survey (SF-12) Summary Subscales (Physical Summary Scale Derived From Items 1-5, 8 and Mental Summary Scale Derived From Items 6, 7, 9-11) Scores|Items: 1.General health 1=poor to 5=excellent 2.Limited moderate activities & 3.Climbing of stairs 1=lot to 3=not at all 4.Accomplished less & 5.Limited in kind of work due to physical health, 6.Accomplished less & 7.Work done less carefully due to emotional problems 1=yes, 2=no 8.Pain interfered with work 1=extremely to 5=not at all 9.Felt calm & 10.Had lot of energy 1=none to 6=all time 11.Felt downhearted & 12.Physical health/emotional problems interfered with social activities 1=all time to 6=none of the time. Higher scores=better QoL, positive changes from baseline=improvement in QoL.|Baseline, Month 12|FAS. Missing values were imputed by LOCF. Number of participants analyzed=Number of subjects with Baseline and Final Visit (LOCF) Scores.||Scores on a scale||Standard Deviation|Mean
810286|NCT01050634|Primary|Change From Baseline in IBCSG LASA Items Scores - QoL Module 24-26|Assessment of severity of 13 items (Being irritable, Sweats, Vaginal discharge, dryness, and itching/irritation, Sleep disturbance, Feeling dizzy, Headaches, Bone or joint pain, Troubled by weight gain, Loss of sexual interest, Difficulties in becoming aroused – all from none to severe, and Bothered by treatment related difficulties (not at all to severely). Individual items scored by measuring distance in mm between left scale anchor and patient’s mark, where no severity=0mm, maximum severity=100mm and negative changes from baseline=lessening of severity.Score range=0-100|Baseline, Month 12|FAS=Number of participants analyzed. Missing values were imputed by LOCF. Number of subjects analyzed for single LASA item (n)=Number of subjects with Baseline and Final Visit (LOCF) scores for the single item.||mm||Standard Deviation|Mean
810287|NCT01050634|Primary|Change From Baseline in Thickness of Endometrium|"Ultrasound measurement. New derived variable for normalization of endometrium thickness:
1 = Endometrium thickness <=5mm 0 = Endometrium thickness >5mm"|Baseline, Month 12|FAS. Missing values were imputed by LOCF. Number of participants analyzed=Number of subjects with Baseline and Final Visit (LOCF) values.||mm||Standard Deviation|Mean
810288|NCT01050634|Primary|Change From Baseline in International Breast Cancer Study Group (IBCSG) Linear Analogues Self-Assessment (LASA) Quality of Life (QoL) Core Questionnaire Scores|10 single-item in LASA format(100mm scale): Physical wellbeing (good to lousy); Mood (happy to miserable); Tiredness, Hot flushes, Feeling sick, Use of arm restricted - all none to a lot; Appetite (good to none); Effort to cope with illness (no effort to great deal of effort); Supported by people (much to not at all); Rating life in current condition (perfect to worst health). Individual items scored by measuring distance in mm between left scale anchor and patient’s mark, where best QoL=0mm, worst QoL =100mm, and negative changes from baseline=improvement in QoL.Score range=0-100|Baseline, Month 12|Full Analysis Set (FAS)=Subjects who received at least 1 dose of study treatment and had at least 1 post-baseline efficacy measurement=Number of participants analyzed. Missing values were imputed by last observation carried forward (LOCF). Subjects analyzed for single item (n)=Subjects with Baseline and Final Visit (LOCF) scores for the item||mm||Standard Deviation|Mean
810289|NCT01050660|Secondary|Anthropometric Measurements(Head Circumference)|Change in head circumference measurement reported in cm/week|At age of 28 days and at discharge|||cm/week||Standard Deviation|Mean
810290|NCT01050660|Secondary|Anthropometric Measurements(Length)|Change in body length measurement reported in cm/week|At age of 28 days and at discharge|||cm/week||Standard Deviation|Mean
810291|NCT01050660|Secondary|Anthropometric Measurements(Body Weight)|Change in body weight measurement reported in g/week|At age of 28 days and at discharge|||g/week||Standard Deviation|Mean
810292|NCT01050660|Secondary|Length of Stay|Defines time to discharge or death.|At discharge from Newborn ICU/death|||Days||Inter-Quartile Range|Mean
810293|NCT01050660|Secondary|Late Onset Sepsis|Bloodstream infection, defined as a positive blood culture obtained after 72 hours of life.|At the discharge from Newborn ICU|||participants who developed LOS|||Number
810294|NCT01050660|Secondary|Incidence of Retinopathy of Prematurity (ROP)||At discharge from Newborn ICU|||participants who developed ROP|||Number
810295|NCT01050660|Secondary|Incidence of Necrotizing Enterocolitis (NEC)||At discharge from Newborn ICU|||participants who developed NEC|||Number
810296|NCT01050660|Secondary|Incidence of Bronchopulmonary Dysplasia (BPD)||36 weeks PMA or discharge home,whichever comes first|||participants who developed BPD|||Number
810297|NCT01050660|Secondary|Mortality Rate- Death Rate Before Discharge From the Hospital||Discharge from the Newborn ICU|||participants|||Number
810298|NCT01050660|Primary|The Presence of Cholestasis at Age of 28 Days or When Full Enteral Nutrition is Achieved, Whichever is Longer.||28 days of age or when full enteral nutrition is acheived, whichever is longer|"Incidence of PNALD at Yale and UCLA NICU prior to the start of the study was around 40%.
Our goal was to decrease incidence by 50%/ Alpha of 5%/ Power of 80% We calculated a sample size of 65 infants in each group"||participants who developed Cholestasis|||Number
810299|NCT01050673|Secondary|Number of Patient's With Serious Adverse Events and Relationship to Device||28 days|||Number of patients|||Number
810300|NCT01050673|Secondary|Number of Patient's With Wound-related Readmissions||28 days and 6 week follow up|||Number of patients|||Number
810301|NCT01050673|Secondary|Length of Hospital Stay (1st Excision to Discharge (Days))||28 days|||Days||Standard Deviation|Median
810302|NCT01050673|Secondary|Percentage of Patients Achieving Stable Closure Within Study Period||28 days|||percentage of patients|||Number
810303|NCT01050673|Secondary|Quantitative Bacteriology From Standardised Tissue Biopsies Pre- /Post- 1st Excision & Pre-closure||28 days|Pre and post-excision values added, (cfu/g) tissue.||cfu/g||Standard Deviation|Median
810304|NCT01050673|Secondary|Cost of Reference Wound-related Surgical Procedures to Achieve Closure||28 days|||Dollars ($)||Standard Deviation|Mean
810305|NCT01050673|Secondary|Cost Per Operative Procedure||28 days|||Dollars $||Standard Deviation|Mean
810306|NCT01050673|Secondary|Time of Actual Excision Procedure||28 days|||Time (Minutes)||Standard Deviation|Median
810316|NCT01050790|Secondary|Progression-free and Overall Survival|"Survival and event-free survival curves (any event of fatality, relapse, acute or chronic GVHD) with Kaplan-Meier curves. The incidence curve for relapse – accounting for the competing risk of fatality – is plotted with step-wise curves. The R statistical software (version 2.15) was used for all time-to-event analyses, with the survival package used for survival curves, and the cmprsk package used for all competing risk curves.
Results: The one-year survival rate is 93.3% (SE = 0.4%), and the two-year survival rate is 86.1% (SE = 0.9%)."|1 year to 2 years|The outcome measure data was collected up to one to two years post transplant.||percentage of participants||95% Confidence Interval|Number
810317|NCT01050790|Secondary|Time to Progression Post Transplant|Time to progression post transplant: For patients not in Complete Response (CR), progressive disease requires one or more: >25% increase in the level of the serum monoclonal paraprotein(absolute increase of at least 0.5 g/dL); > 25% increase in 24-hour urinary light chain excretion(absolute increase of at least 200m/24 hours). Increase plasma cells in a bone marrow aspirate( absolute increase of at least 10%). Definite increase in the size of existing bone lesions or soft tissue plasmacytomas. Development of new bone lesions or soft tissue plasmacytomas. Development of hypercalcemia (corrected serum Ca > 11.5 mg/dL or > 2.65 mmol/L) not attributable to any other cause. All relapse categories require two consecutive assessments made any time before classification as relapse or progressive disease.|28 months|Progression is collected anytime after transplant.||months||Full Range|Median
810318|NCT01050790|Secondary|Toxicity as Assessed by NCI CTCAE v3.0|Time frame includes after stem cell transplant engraftment. Toxicity post ALI infusion: 1 patient grade 1 hypertension 90 min post infusion. Toxicity post Rev maintenance: 1 patient not tolerated, 1 patient dose decreased due to counts.|6 months|||participants|||Number
810319|NCT01050790|Secondary|Complete Response Rate at 6 Months|16 of 17 patients proceeded to transplant. 6 month CR rate post transplant was 8/16 (50%).|6 months|1 patient did not proceed to transplant.||percentage of participants|||Number
810320|NCT01050790|Primary|Feasibility to Mobilize and Infuse Autologous Lymphocytes (ALI) After Immunomodulatory Therapy and After Stem Cell Transplant Engraftment|Time frame is post 2nd and 3rd cycles of rev/aza and after stem cell transplant engraftment.|6 months|17 of 17 patients were able to mobilize lymphocytes. 16 of 17 patients had lymphocytes infused post transplant. 1 patient was not able to mobilize stem cells and so did not go to transplant.||participants|||Number
810321|NCT01050816|Secondary|Average Change From Baseline in the Modified Hannover Scoring System at 12 Months Post Surgery|The Modified Hannover Score System contains information about patient’s status(pain-36, clinical finding- 4, patient's subjective assessment- 25, statics- 6, fuction- 26, radiology-7;best score-104, worst score-0).The scores of 27 patients in the FAS group were taken in the screening period (Visit S), 12 months after transplantation (Visit 7). The difference of the scores at screening and 12 months after transplantation was compared by using the paired t-test. Improvements were compared and analyzed at each time point.|baseline(preoperative stage),12months post-surgery|Among the 30 patients, 27 who received CHONDRON transplantation became subjects for FAS analysis, as validity evaluation analysis subjects. The remaining 3 patients were omitted, being excluded from the FAS analysis. (1 subject refused to participate, 2 were unable to do follow-up.)||scores||Standard Deviation|Mean
810322|NCT01050816|Secondary|Average Change From Baseline in 100mm Visual Analogue Scale(VAS) at 12months Post-surgery|"A VAS is a horizontal line, 100mm in length, anchored by word descriptors about pain at each end.The VAS is measured degree of pain from 0mm to 100mm. Severe pain is represented by 100mm and no pain is represented by 0mm. The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks.
The difference of secondary evaluation variables VAS at baseline and after the end of the trial were analyzed by using paired t-test. Improvements were compared and analysis by each time point."|baseline(preoperative stage),12months post-surgery|Among the 30 patients, 27 who received CHONDRON transplantation became subjects for FAS analysis, as validity evaluation analysis subjects. The remaining 3 patients were omitted, being excluded from the FAS analysis. (1 subject refused to participate, 2 were unable to do follow-up.)||mm||Standard Deviation|Mean
810323|NCT01050816|Primary|Average Change From Baseline in American Orthopedic Foot and Ankle Society(AOFAS) at 12 Months Post-surgery|"AOFAS scores(best score-100,worst score- 0 )
pain-none:40/Strong and Always present:O
Function
activities-without support activities:10/need restrain, clutch , walker or wheelchair:0
Maximum gait distance- more than 6:5/ less than 1:0
gait surface-easy in any surace:5/strong difficult in irregular ground stair or slopes:0
Gait abnormality-none:8/marked:0
saggital mobidity- normal or minimal restrain:6/strong restraint:0
hindfoot mobidity -normal minimal restrain:6/strong restrain:0
ankle and hindfoot stability - stable:8/unstable:0
alignment- good:10/bad:0"|baseline(preoperative stage),12months post-surgery|Among the 30 patients, 27 who received CHONDRON transplantation became subjects for Full Analysis Set(FAS) analysis, as validity evaluation analysis subjects. The remaining 3 patients were omitted, being excluded from the FAS analysis. (1 subject refused to participate, 2 were unable to do follow-up.)||scores||Standard Deviation|Mean
810324|NCT01050946|Secondary|Disease-free Survival:Death or Relapse Will be Considered Events for This Endpoint.||3 years|||participants|||Number
810325|NCT01050946|Secondary|Transplant Related Mortality (TRM): TRM is Death Occurring in Patients in Continuous Complete Remission.||1 year|only pt who was enrolled died of TRM||participants|||Number
810326|NCT01050946|Secondary|Time to Acute GVHD: We Will Assess the Incidence and Severity of Grades II-IV and Grades III-IV Acute GVHD From Day of Transplant.||100 days|only one participant - no analysis done|||||
810327|NCT01050946|Secondary|Time to Platelet Engraftment: To Assess the Incidence of Platelet Engraftment From Day of Transplant,||100 days|No further analysis reported as only one patient enrolled|||||
810328|NCT01050946|Secondary|Time to Neutrophil Engraftment: To Assess the Incidence of Neutrophil Engraftment From Day of Transplant|time to neutrophil recovery after transplant|100 days|Patient engrafted neutrophils and platelets but no statistical analysis possible|||||
810329|NCT01050946|Secondary|Time to Relapse: To Assess the Incidence of Acute Leukemia or Lymphoma Relapse From Day of Transplant|NOT analyzed since there was only patient and no relapse was observed till patient passed away|2 years|Patient did not live to 2 years, no relapse observed|||||
810330|NCT01050946|Primary|The Primary Objective is to Estimate the Overall Survival, Separately in the Two Risk Strata.||3 years|Only one patient enrolled on study. Patient died prior to time frame of 3 years. It is not possible to assess this outcome measure.|||||
810331|NCT01050998|Secondary|Number of Participants Exhibiting Anti-Drug Antibodies (ADAs) to Mavrilimumab at Any Visit|ADA detection measured by using electrochemiluminescence assays.|Day 1 up to Day 169|The immunogenicity population included all participants who received at least 1 dose of CAM-3001 and for whom at least one serum sample for immunogenicity testing was available.||participants|||Number
810332|NCT01050998|Secondary|Accumulation Ratio for Mavrilimumab After Last Dose by Region|Accumulation ratio was calculated as ratio of AUCtau after last dose and AUCtau after first dose. Data for European and Japanese regions were reported.|Blood samples were collected at pre-dose on Days 1, 4, 8, 15, 29, 57, and 85 as well as during follow up on Days 88, 99, 113 and 169|"The PK population included all participants who received mavrilimumab and for whom serum concentrations of mavrilimumab were available for PK data analyses. Here “N” signifies participants who were evaluable for this measure and n signifies participants who were evaluable for the specified region for each arm, respectively."||ratio||Standard Deviation|Geometric Mean
810333|NCT01050998|Secondary|Terminal Phase Elimination Half-Life (t1/2) for Mavrilimumab After Last Dose by Region|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Data for European and Japanese regions were reported.|Blood samples were collected at pre-dose on Days 1, 4, 8, 15, 29, 57, and 85 as well as during follow up on Days 88, 99, 113 and 169|"The PK population included all participants who received mavrilimumab and for whom serum concentrations of mavrilimumab were available for PK data analyses. Here “N” signifies participants who were evaluable for this measure and n signifies participants who were evaluable for the specified region for each arm, respectively."||days||Standard Deviation|Mean
810334|NCT01050998|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Mavrilimumab After Last Dose by Region|Data for European and Japanese regions were reported.|Blood samples were collected at pre-dose on Days 1, 4, 8, 15, 29, 57, and 85 as well as during follow up on Days 88, 99, 113 and 169|"The PK population included all participants who received mavrilimumab and for whom serum concentrations of mavrilimumab were available for PK data analyses. Here “N” signifies participants who were evaluable for this measure and n signifies participants who were evaluable for the specified region for each arm, respectively."||ng*day/mL||Standard Deviation|Geometric Mean
810335|NCT01050998|Secondary|Time to Reach Maximum Observed Serum Concentration (Tmax) for Mavrilimumab After Last Dose by Region|Data for European and Japanese regions were reported.|Blood samples were collected at pre-dose on Days 1, 4, 8, 15, 29, 57, and 85 as well as during follow up on Days 88, 99, 113 and 169|"The PK population included all participants who received mavrilimumab and for whom serum concentrations of mavrilimumab were available for PK data analyses. Here “N” signifies participants who were evaluable for this measure and n signifies participants who were evaluable for the specified region for each arm, respectively."||days||Full Range|Median
810336|NCT01050998|Secondary|Maximum Observed Serum Concentration (Cmax) for Mavrilimumab After Last Dose by Region|Data for European and Japanese regions were reported.|Blood samples were collected at pre-dose on Days 1, 4, 8, 15, 29, 57, and 85 as well as during follow up on Days 88, 99, 113 and 169|"The PK population included all participants who received mavrilimumab and for whom serum concentrations of mavrilimumab were available for PK data analyses. Here “N” signifies participants who were evaluable for this measure and n signifies participants who were evaluable for the specified region for each arm, respectively."||ng/mL||Standard Deviation|Geometric Mean
810337|NCT01050998|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Mavrilimumab After First Dose by Region|Data for European and Japanese regions were reported.|Blood samples were collected at pre-dose on Days 1, 4, 8, 15, 29, 57, and 85 as well as during follow up on Days 88, 99, 113 and 169|"The PK population included all participants who received mavrilimumab and for whom serum concentrations of mavrilimumab were available for PK data analyses. Here “N” signifies participants who were evaluable for this measure and n signifies participants who were evaluable for the specified region for each arm, respectively."||nanogram*day per milliliter (ng*day/mL)||Standard Deviation|Geometric Mean
810338|NCT01050998|Secondary|Time to Reach Maximum Observed Serum Concentration (Tmax) for Mavrilimumab After First Dose by Region|Data for European and Japanese regions were reported.|Blood samples were collected at pre-dose on Days 1, 4, 8, 15, 29, 57, and 85 as well as during follow up on Days 88, 99, 113 and 169|"The PK population included all participants who received mavrilimumab and for whom serum concentrations of mavrilimumab were available for PK data analyses. Here “N” signifies participants who were evaluable for this measure and n signifies participants who were evaluable for the specified region for each arm, respectively."||days||Full Range|Median
810339|NCT01050998|Secondary|Maximum Observed Serum Concentration (Cmax) for Mavrilimumab After First Dose by Region|Data for European and Japanese regions were reported.|Blood samples were collected at pre-dose on Days 1, 4, 8, 15, 29, 57, and 85 as well as during follow up on Days 88, 99, 113 and 169|"The pharmacokinetic (PK) population included all participants who received mavrilimumab and for whom serum concentrations of mavrilimumab were available for PK data analyses. Here “N” signifies participants who were evaluable for this measure and n signifies participants who were evaluable for the specified region for each arm, respectively."||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
810340|NCT01050998|Secondary|Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose|Participants received MTX at stable and tolerated dose during baseline were categorized as “low dose (<12.5 mg per week [mg/wk])”, “medium dose (>=12.5 - <20 mg/wk)”, and “high dose (>=20 mg/wk)”. Participants received oral CST at stable dose during baseline were categorized as “low dose (<5 mg/day)”, and “high dose (>=5 mg/day)”. Change in MTX and CST dose from baseline between Day 1-85 and Day 86-169 were categorized as follows: ‘Increased’, ‘no change’ and ‘decreased’. Participants were counted once with dose increases counted first, followed by no change and then dose decreases.|Baseline, Day 1 to 85, Day 86 to 169|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here n signifies participants who were evaluable for the specified parameter for each arm, respectively."||participants|||Number
810399|NCT01044693|Primary|Change in Systolic Blood Pressure During the Night|Maximal change from baseline in systolic blood pressure, measured from 8 pm to 8 am, after a single dose of the intervention|8 pm - 8 am|Participants who completed the 4 treatment arms||mm Hg||Standard Error|Mean
810400|NCT01044706|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|maximum observed concentration of drug substance in plasma|144 hour|||ng/mL||Standard Deviation|Geometric Mean
810341|NCT01050998|Secondary|Number of Participants Who Had Additional Medications|Additional medication included concomitant medication (medication used for purposes other than managing rheumatoid arthritis [RA]) and RA medication (for managing RA). Number of participants who used concomitant medication and RA medication was reported by anatomical therapeutic chemical (ATC) classification system.|Baseline up to Day 169|The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues.||participants|||Number
810342|NCT01050998|Secondary|Serum Concentration of Anti-Citrullinated-Peptide-Antibody (ACPA)||Day 85|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||units per milliliter||Standard Deviation|Mean
810343|NCT01050998|Secondary|Serum Concentration of Rheumatoid Factor (RF)||Day 85|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||units per milliliter||Standard Deviation|Mean
810344|NCT01050998|Secondary|Serum Concentration of Erythrocyte Sedimentation Rate (ESR) by Region|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Data for European and Japanese regions were reported.|Day 85|"ITT population. Six participants were excluded from the ITT population for data integrity issues. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for this measure for the specified region for each arm, respectively."||mm/hr||Standard Deviation|Mean
810345|NCT01050998|Secondary|Serum Concentration of Erythrocyte Sedimentation Rate (ESR)|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube.|Day 85|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||mm/hr||Standard Deviation|Mean
810346|NCT01050998|Secondary|Serum Concentration of C-Reactive Protein (CRP) by Region|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Data for European and Japanese regions were reported.|Day 85|"ITT population. Six participants were excluded from the ITT population for data integrity issues. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for this measure for the specified region for each arm, respectively."||mg/L||Standard Deviation|Mean
810347|NCT01050998|Secondary|Serum Concentration of C-Reactive Protein (CRP)|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Day 85|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||mg/L||Standard Deviation|Mean
810348|NCT01050998|Secondary|Health Assessments Questionnaire (HAQ) Pain Score by Region|Participants were asked to assess the severity of pain in the past week on a 100 VAS with 0 being no pain and 100 being severe pain. Data for European and Japanese regions were reported.|Day 85|"ITT population. Six participants were excluded from the ITT population for data integrity issues. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for this measure for the specified region for each arm, respectively."||units on a scale||Standard Deviation|Mean
810349|NCT01050998|Secondary|Health Assessments Questionnaire (HAQ) Pain Score|Participants were asked to assess the severity of pain in the past week on a 100 VAS with 0 being no pain and 100 being severe pain.|Day 85|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||units on a scale||Standard Deviation|Mean
810350|NCT01050998|Secondary|Health Assessments Questionnaire-Disability Index (HAQ-DI) Score by Region|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. Data for European and Japanese regions were reported.|Day 85|"ITT population. Six participants were excluded from the ITT population for data integrity issues. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for this measure for the specified region for each arm, respectively."||units on a scale||Standard Deviation|Mean
810351|NCT01050998|Secondary|Health Assessments Questionnaire-Disability Index (HAQ-DI) Score|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Day 85|"ITT population. Six participants were excluded from the ITT population for data integrity issues. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for this measure for the specified region for each arm, respectively."||units on a scale||Standard Deviation|Mean
810352|NCT01050998|Secondary|Patient Pain Assessment Score by Region|Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain. Data for European and Japanese regions were reported.|Day 85|"ITT population. Six participants were excluded from the ITT population for data integrity issues. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for this measure for the specified region for each arm, respectively."||mm||Standard Deviation|Mean
810353|NCT01050998|Secondary|Patient Pain Assessment Score|Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.|Day 85|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||mm||Standard Deviation|Mean
810354|NCT01050998|Secondary|Patient Global Assessment of Disease Activity Score by Region|"Participants responded to a question, Considering all the ways your arthritis affects you, how are you feeling today? by using a 0 - 100 mm VAS, where 0 = very well and 100 = very poorly. Data for European and Japanese regions were reported."|Day 85|"ITT population. Six participants were excluded from the ITT population for data integrity issues. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for the specified region for each arm, respectively."||mm||Standard Deviation|Mean
810355|NCT01050998|Secondary|Patient Global Assessment of Disease Activity Score|"Participants responded to a question, Considering all the ways your arthritis affects you, how are you feeling today? by using a 0 - 100 millimeter (mm) VAS, where 0 = very well and 100 = very poorly."|Day 85|The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||mm||Standard Deviation|Mean
810356|NCT01050998|Secondary|Physician Global Assessment of Disease Activity Score by Region|Physician Global Assessment of Arthritis was measured on a 0 to 10 cm VAS, where 0 cm = very good and 10 cm = very bad. Data for European and Japanese regions were reported.|Day 85|"ITT population. Six participants were excluded from the ITT population for data integrity issues. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for the specified region for each arm, respectively."||cm||Standard Deviation|Mean
810357|NCT01050998|Secondary|Physician Global Assessment of Disease Activity Score|Physician Global Assessment of Arthritis was measured on a 0 to 10 centimeter (cm) Visual Analogue Scale (VAS), where 0 cm = very good and 10 cm = very bad.|Day 85|The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||cm||Standard Deviation|Mean
810358|NCT01050998|Secondary|Swollen and Tender Joint Count by Region|Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form, no swelling = 0, swelling =1. Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form, no tenderness = 0, tenderness = 1. Data for the European and Japanese regions were reported.|Day 85|"ITT population. Six participants were excluded from the ITT population for data integrity issues. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for the specified region for each arm, respectively."||joints||Standard Deviation|Mean
810359|NCT01050998|Secondary|Swollen and Tender Joint Count|Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form, no swelling = 0, swelling =1. Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form, no tenderness = 0, tenderness = 1.|Day 85|The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||joints||Standard Deviation|Mean
810360|NCT01050998|Secondary|Continuous ACR (ACRn) Score by Region|ACR score - continuous (ACRn) was defined as the minimum of the percentage improvement in TJC, SJC and the median of the percentage improvements in the other five components of the ACR criteria (participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; disability index of the HAQ; and CRP). Total score range was -100 to 100, where negative numbers indicated worsening and positive numbers indicated improvement. Data for European and Japanese regions were reported.|Day 85|"ITT population. Six participants were excluded from the ITT population for data integrity issues. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for this measure for the specified region for each arm, respectively."||units on a scale||Standard Error|Mean
810361|NCT01050998|Secondary|Continuous ACR (ACRn) Score|ACR score - continuous (ACRn) was defined as the minimum of the percentage improvement in TJC, SJC and the median of the percentage improvements in the other five components of the ACR criteria (participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; disability index of the HAQ; and CRP). Total score range was -100 to 100, where negative numbers indicated worsening and positive numbers indicated improvement.|Day 85|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||units on a scale||Standard Error|Mean
810401|NCT01044706|Primary|AUC0-144 (Area Under the Concentration-time Curve From Time Zero to 144 Hour Post-dose)|AUC0-144 (area under the concentration-time curve from time zero to 144 hour post-dose)|144 hour|per protocol||ng*h/mL||Standard Deviation|Geometric Mean
810362|NCT01050998|Secondary|Number of Participants Who Achieved ACR Categorical Responses|"ACR20, ACR50, and ACR70, were defined as >=20%, >=50%, or >=70% improvement, respectively, in: SJC and TJC and >=20%, >=50%, or >=70% improvement, respectively, in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP. ACR responses were categorized as No response, ACR20 but not ACR50, ACR50 but not ACR70, and ACR70."|Day 85|The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues.||participants|||Number
810363|NCT01050998|Secondary|Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20), ACR50 and ACR70 Responses at Day 85 by Region|ACR20, ACR50, and ACR70, were defined as >=20%, >=50%, or >=70% improvement, respectively, in: SJC and TJC and >=20%, >=50%, or >=70% improvement, respectively, in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP. Data for the European and Japanese regions were reported.|Day 85|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here n signifies participants who were evaluable for this measure for the specified region for each arm, respectively."||percentage of participants|||Number
810364|NCT01050998|Secondary|Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20), ACR50 and ACR70 Responses at Day 85|ACR20, ACR50, and ACR70, were defined as greater than or equal to (>=) 20 percent (%),>=50%, or >=70% improvement, respectively, in: swollen joint count and tender joint count and >=20%, >=50%, or >=70% improvement, respectively, in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Day 85|The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues.||percentage of participants|||Number
810365|NCT01050998|Secondary|Duration of DAS28 (CRP) and DAS28 (ESR) Response and Remission|DAS28 calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst) and CRP (mg/L) for DAS28 (CRP) or ESR (mm/hour) for DAS28 (ESR). Total score range: 0-9.4, higher score = more disease activity. DAS28 <3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission. Response was defined as 1.2 decrease from baseline in DAS28 (CRP) or DAS28 (ESR) score. Remission was defined as less than 2.6 DAS28 (CRP) or DAS28 (ESR) score. Expected duration of response (DOR) was calculated as response rate (in percentage) multiplied by mean DOR (in days) by using Weibull Model. Duration of DAS28 (CRP) and DAS28 (ESR) remission were not analyzed because very few participants achieved remission in the overall study population.|Baseline up to Day 169|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here n signifies participants who were evaluable for this measure for the specified parameter for each arm, respectively."||Percentage of days|||Number
810366|NCT01050998|Secondary|Time to Onset for DAS28 (CRP) and DAS (ESR) Response and Remission by Region|DAS28 calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst) and CRP (mg/L) for DAS28 (CRP) or ESR (mm/hour) for DAS28 (ESR). Total score range: 0-9.4, higher score = more disease activity. DAS28 <3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission. Response was defined as 1.2 decrease from baseline in DAS28 (CRP) or DAS28 (ESR) score. Remission was defined as less than 2.6 DAS28 (CRP) or DAS28 (ESR) score. Time to response for DAS28 (CRP) and DAS28 (ESR) by region were reported. Time to remission for DAS28 (CRP) and DAS28 (ESR) by region were not analyzed because time to remission for the overall study population could not be achieved.|Baseline up to Day 169 (follow-up)|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here n signifies participants who were evaluable for this measure for the specified region for each arm, respectively."||days||95% Confidence Interval|Median
810367|NCT01050998|Secondary|Time to Onset for DAS28 (CRP) and DAS (ESR) Response and Remission|DAS28 calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst) and CRP (mg/L) for DAS28 (CRP) or ESR (mm/hour) for DAS28 (ESR). Total score range: 0-9.4, higher score = more disease activity. DAS28 <3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission. Response was defined as 1.2 decrease from baseline in DAS28 (CRP) or DAS28 (ESR) score. Remission was defined as less than 2.6 DAS28 (CRP) or DAS28 (ESR) score.|Baseline up to Day 169 (follow-up)|The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues.||days||95% Confidence Interval|Median
810368|NCT01050998|Secondary|Percentage of Participants Who Achieved DAS28 (CRP) and DAS28 (ESR) Remission at Day 85 by Region|DAS28 calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst) and CRP (mg/L) for DAS28 (CRP) or ESR (mm/hour) for DAS28 (ESR). Total score range: 0-9.4, higher score = more disease activity. DAS28 <3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission. Remission was defined as less than 2.6 DAS28 (ESR) or DAS28 (CRP) score. DAS28 (CRP) and DAS28 (ESR) for the European and Japanese regions were reported.|Day 85|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here n signifies participants who were evaluable for this measure for the specified region for each arm, respectively."||percentage of participants|||Number
825407|NCT01190566|Secondary|Constant for the Transfer of the Contrast Agent From the Plasma Compartment Into the Extracellular Extravascular Space (Ktrans)||Baseline, post-1st chemotherapy|||min-1||Standard Deviation|Mean
810369|NCT01050998|Secondary|Percentage of Participants Who Achieved DAS28 (CRP) and DAS28 (ESR) Remission at Day 85|DAS28 calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst) and CRP (mg/L) for DAS28 (CRP) or ESR (mm/hour) for DAS28 (ESR). Total score range: 0-9.4, higher score = more disease activity. DAS28 <3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission. Remission was defined as less than 2.6 DAS28 (ESR) or DAS28 (CRP) score.|Day 85|The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues.||percentage of participants|||Number
810370|NCT01050998|Secondary|Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 by Region|DAS28 calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst) and CRP (mg/L) for DAS28 (CRP) or ESR (mm/hour) for DAS28 (ESR). Total score range: 0-9.4, higher score = more disease activity. DAS28 <3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission. DAS28 (CRP) and DAS28 (ESR) for the European and Japanese regions were reported.|Baseline and Day 85|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here n signifies participants who were evaluable for this measure for the specified region for each arm, respectively."||units on a scale||Standard Error|Mean
810371|NCT01050998|Secondary|Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85|DAS28 calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst) and CRP (mg/L) for DAS28 (CRP) or ESR (mm/hour) for DAS28 (ESR). Total score range: 0-9.4, higher score = more disease activity. DAS28 <3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission.|Baseline and Day 85|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||units on a scale||Standard Error|Mean
810372|NCT01050998|Primary|Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)|Any medically significant change in laboratory evaluations were recorded as adverse events. Following parameters were analyzed for laboratory examination: hematology (haemoglobin, reticulocytes, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes, mean corpuscular volume, mean corpuscular haemoglobin concentration); serum chemistry (creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, gamma glutamyl transferase, CRP, ESR, albumin, total cholesterol, triglycerides, rheumatoid factor and anti-cyclic citrullinated peptide antibodies); urinalysis (albumin, glucose, protein, blood, nitrite).|Baseline up to Day 169 (follow-up)|The safety population included all participants who received any dose of investigational product.||participants|||Number
810373|NCT01050998|Primary|Change From Baseline in Oxygen Saturation Level at Day 85|Oxygen saturation measured by pulse oximetry which measures the concentration of oxygen in the blood.|Baseline and Day 85|"The safety population included all participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure at the specified time point for each arm, respectively."||percent saturation||Standard Deviation|Mean
810374|NCT01050998|Primary|Oxygen Saturation Level at Day 85 by Region|Oxygen saturation measured by pulse oximetry which measures the concentration of oxygen in the blood. Oxygen saturation for the European and Japanese regions were reported.|Day 85|"The safety population included all participants who received any dose of investigational product. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for this measure for the specified region for each arm, respectively."||percent saturation||Standard Deviation|Mean
810375|NCT01050998|Primary|Oxygen Saturation Level at Day 85|Oxygen saturation measured by pulse oximetry which measures the concentration of oxygen in the blood.|Day 85|"The safety population included all participants who received any dose of investigational product. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||percent saturation||Standard Deviation|Mean
810376|NCT01050998|Primary|Categorized Dyspnea Score at Day 85|Modified Borg dyspnea scale is a validated participant reported outcome assessing participant’s perceived difficulty in breathing (dyspnea). The scale ranges from 0 (nothing at all) to 10 (maximal difficulty). Higher scores indicate greater difficulty in breathing. The modified BORG dyspnea scale was categorized as - no/slight (0 to 2), moderate (3 and 4), severe (5 and 6) and very severe breathlessness (7 and above).|Day 85|"The safety population included all participants who received any dose of investigational product. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||participants|||Number
810377|NCT01050998|Primary|Change From Baseline in Dyspnea Score at Day 85|Modified Borg dyspnea scale is a validated participant reported outcome assessing participant’s perceived difficulty in breathing (dyspnea). The scale ranges from 0 (nothing at all) to 10 (maximal difficulty). Higher scores indicate greater difficulty in breathing.|Baseline and Day 85|"The safety population included all participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure at the specified time point for each arm, respectively."||units on a scale||Standard Deviation|Mean
810378|NCT01050998|Primary|Dyspnea Score at Day 85|Modified Borg dyspnea scale is a validated participant reported outcome assessing participant’s perceived difficulty in breathing (dyspnea). The scale ranges from 0 (nothing at all) to 10 (maximal difficulty). Higher scores indicate greater difficulty in breathing.|Day 85|"The safety population included all participants who received any dose of investigational product. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||units on a scale||Standard Deviation|Mean
810402|NCT01044732|Secondary|Times for Withdrawal Phase and for Complete Procedure|For all examinations with each method (SC or TEC), mean time for withdrawal phase and mean time for total procedure|Acute - subjects were followed for the duration of the procedures, an average of 40 minutes.|All subjects in study (i.e., Group A and Group B combined)||Minutes||Standard Deviation|Mean
810379|NCT01050998|Primary|Change From Baseline in Diffusing Capacity for Carbon Monoxide (DLCO) at Day 85|DLCO is a pulmonary function test, and measures the partial pressure difference between inspired and expired carbon monoxide.|Baseline and Day 85|"The safety population included all participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure at the specified time point for each arm, respectively."||percent diffusion capacity||Standard Deviation|Mean
810380|NCT01050998|Primary|Diffusing Capacity for Carbon Monoxide (DLCO) at Day 85 by Region|DLCO is a pulmonary function test, and measures the partial pressure difference between inspired and expired carbon monoxide. DLCO% for the European and Japanese regions were reported.|Day 85|"The safety population included all participants who received any dose of investigational product. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for this measure for the specified region for each arm, respectively."||percent diffusion capacity||Standard Deviation|Mean
810381|NCT01050998|Primary|Diffusing Capacity for Carbon Monoxide (DLCO) at Day 85|DLCO is a pulmonary function test that measures the partial pressure difference between inspired and expired carbon monoxide.|Day 85|"The safety population included all participants who received any dose of investigational product. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||percent diffusion capacity||Standard Deviation|Mean
810382|NCT01050998|Primary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85|FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.|Baseline and Day 85|"The safety population included all participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure at the specified time point for each arm, respectively."||liters||Standard Deviation|Mean
810383|NCT01050998|Primary|Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 by Region|FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FEV1 and FVC at Day 85 for the European and Japanese regions were reported.|Day 85|"The safety population included all participants who received any dose of investigational product. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for the specified region for each arm, respectively."||liters||Standard Deviation|Mean
810384|NCT01050998|Primary|Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85|FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.|Day 85|The safety population included all participants who received any dose of investigational product. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||liters||Standard Deviation|Mean
810385|NCT01050998|Primary|Number of Participants With Abnormal Electrocardiogram (ECG) Results|12-lead ECG was recorded and corrected QT (QTc) interval was measured with the participant in a rested supine position for at least 10 minutes. Any ECG abnormality deemed clinically significant as per investigator’s discretion were reported.|Baseline up to Day 169 (follow-up)|The safety population included all participants who received any dose of investigational product.||participants|||Number
810386|NCT01050998|Primary|Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)|Vital sign assessments included blood pressure, pulse rate, temperature, and respiration rate. Vital signs abnormalities reported as TEAEs were reported.|Baseline up to Day 169 (follow-up)|The safety population included all participants who received any dose of investigational product.||participants|||Number
810387|NCT01050998|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up Day 169 that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to Day 169 (follow-up)|The safety population included all participants who received any dose of investigational product.||participants|||Number
810388|NCT01050998|Primary|Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region|DAS28 (ESR) response by EULAR category were used to measure individual response as none, moderate, and good, depending on the extent of change from baseline and the level of disease activity reached. Good response: change from baseline >1.2 with baseline DAS28 (ESR) <3.2; moderate response: change from baseline >1.2 with baseline DAS28 (ESR) >=3.2 to =< 5.1 or change from baseline >=0.6 to =< 1.2 with baseline DAS28 (ESR) >=3.2 to =<5.1; no response: change from baseline <0.6 or change from baseline >=0.6 and =<1.2 with baseline DAS28 (ESR) >5.1. DAS28 (ESR) response by EULAR category at Day 85 for the European and Japanese regions were reported.|Day 85|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here n signifies participants who were evaluable for the specified region for each arm, respectively."||percentage of participants|||Number
810389|NCT01050998|Primary|Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85|DAS28 (ESR) response by EULAR category were used to measure individual response as none, moderate, and good, depending on the extent of change from baseline and the level of disease activity reached. Good response: change from baseline >1.2 with baseline DAS28 (ESR) <3.2; moderate response: change from baseline >1.2 with baseline DAS28 (ESR) >=3.2 to =< 5.1 or change from baseline >=0.6 to =< 1.2 with baseline DAS28 (ESR) >=3.2 to =<5.1; no response: change from baseline <0.6 or change from baseline >=0.6 and =<1.2 with baseline DAS28 (ESR) >5.1.|Day 85|The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues.||percentage of participants|||Number
810390|NCT01050998|Primary|Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region|DAS28 (CRP) response by EULAR category were used to measure individual response as none, moderate, and good, depending on the extent of change from baseline and the level of disease activity reached. Good response: change from baseline >1.2 with baseline DAS28 (CRP) <3.2; moderate response: change from baseline >1.2 with baseline DAS28 (CRP) >=3.2 to =< 5.1 or change from baseline >=0.6 to =< 1.2 with baseline DAS28 (CRP) >=3.2 to =<5.1; no response: change from baseline <0.6 or change from baseline >=0.6 and =<1.2 with baseline DAS28 (CRP) >5.1. DAS28 (CRP) response by EULAR category at Day 85 for the European and Japanese regions were reported.|Day 85|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here n signifies participants who were evaluable for the specified region for each arm, respectively."||percentage of participants|||Number
810391|NCT01050998|Primary|Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85|DAS28 (CRP) response by EULAR category were used to measure individual response as none, moderate, and good, depending on the extent of change from baseline and the level of disease activity reached. Good response: change from baseline >1.2 with baseline DAS28 (CRP) <3.2; moderate response: change from baseline >1.2 with baseline DAS28 (CRP) >=3.2 to less than or equal to (=<) 5.1 or change from baseline >=0.6 to =< 1.2 with baseline DAS28 (CRP) >=3.2 to =<5.1; no response: change from baseline <0.6 or change from baseline >=0.6 and =<1.2 with baseline DAS28 (CRP) >5.1.|Day 85|The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues.||percentage of participants|||Number
810392|NCT01050998|Primary|Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using Erythrocyte Sedimentation Rate (DAS28 [ESR]) at Day 85 by Region|DAS28 (ESR) calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]). Total score range: 0-9.4, higher score = more disease activity. DAS28 (ESR) <3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission. A Day 85 responder was defined as a participant who experienced more than 1.2 decrease from baseline in DAS28 (ESR) score at Day 85. DAS28 (ESR) response at Day 85 for the European and Japanese regions were reported.|Day 85|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here n signifies participants who were evaluable for the specified region for each arm, respectively."||percentage of participants|||Number
810393|NCT01050998|Primary|Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using Erythrocyte Sedimentation Rate (DAS28 [ESR]) at Day 85|DAS28 (ESR) calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]). Total score range: 0-9.4, higher score = more disease activity. DAS28 (ESR) <3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission. A Day 85 responder was defined as a participant who experienced more than 1.2 decrease from baseline in DAS28 (ESR) score at Day 85.|Day 85|The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues.||percentage of participants|||Number
810394|NCT01050998|Primary|Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Response at Day 85 by Region|DAS28 (CRP) calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and CRP (mg/L). Total score range: 0-9.4, higher score= more disease activity. DAS28 (CRP) <3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission. A Day 85 responder was defined as a participant who experienced more than 1.2 decrease from baseline in DAS28 (CRP) score at Day 85. DAS28 (CRP) response at Day 85 for the European and Japanese regions were reported.|Day 85|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here n signifies participants who were evaluable for the specified region for each arm, respectively."||percentage of participants|||Number
810395|NCT01050998|Primary|Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Response at Day 85|DAS28 (CRP) calculated swollen joint count (SJC) and tender joint count (TJC) using the 28 joints, general health (GH) using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and CRP (milligram per Liter [mg/L]). Total score range: 0-9.4, higher score= more disease activity. DAS28 (CRP) less than (<) 3.2 = low disease activity, greater than or equal to (>=) 3.2 to 5.1 = moderate to high disease activity and <2.6= remission. A Day 85 responder was defined as a participant who experienced more than 1.2 decrease from baseline in DAS28 (CRP) score at Day 85.|Day 85|The intent-to-treat (ITT) population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues.||percentage of participants|||Number
810396|NCT01044693|Secondary|Change in Heart Rate During the Night|Change from baseline (8 pm) in heart rate at the time of maximal BP-lowering effect|8 pm - 8 am|Participants who completed the 4 treatment arms||bpm||Standard Error|Mean
810397|NCT01044693|Secondary|Orthostatic Tolerance the Following Morning|Orthostatic tolerance was defined as the area under the curve of standing systolic blood pressure calculated by the trapezoidal rule (upright systolic blood pressure multiplied by standing time) during a 10-minute standing test|10 min standing|Comparisons were made only for patients who could stand after all treatment groups||mm Hg*min||Standard Error|Mean
810398|NCT01044693|Secondary|Nocturnal Urinary Sodium Excretion|Nocturnal sodium excretion was defined as the ratio of urinary sodium to urinary creatinine.|8 pm - 8 am|Participants with complete urine collections during the 4 study nights||mEq/mg||Standard Error|Mean
810405|NCT01044758|Primary|Brain Activity in the Dentate Gyrus / CA3 Subregion of the Hippocampus Measured With Blood Oxygenation Level Dependent (BOLD) Functional MRI|Measurement of average brain activity in the dentate gyrus / CA3 subregion of the hippocampus measured with BOLD functional MRI in patients with mild cognitive impairment on placebo and on drug compared to average brain activity in this brain area in control subjects.|2 weeks|||mean beta coefficient||Standard Error|Mean
810406|NCT01044771|Secondary|Patients Without HIV Re-bound|HIV Viral load blood test at week 24|24 weeks|Subjects entered with undetectable Viral Load and Proteinuria||participants|||Number
810407|NCT01044771|Primary|Patients With Reduced or Resolved Proteinuria|Measurement of Protein in Urine samples at end of study visit|24 weeks|||participants|||Number
810408|NCT01044862|Secondary|Live Birth Rate||Participants were followed for the duration of their treatment and, if pregnant through 6 weeks post-delivery, up to 66 weeks|||participants|||Number
810409|NCT01044862|Secondary|Time to Pregnancy||Participants were followed for the duration of their treatment and, if pregnant through 6 weeks post-delivery, up to 66 weeks|||days||Standard Deviation|Mean
810410|NCT01044862|Secondary|Rate of Pregnancy Obtained||Participants were followed for the duration of their treatment and, if pregnant through 6 weeks post-delivery, up to 66 weeks|||participants|||Number
810411|NCT01044862|Primary|Multiple Gestation Rate Following Recruitment of Multiple Follicular Development With an AI, as Compared to CC and FSH.||Participants were followed for the duration of their treatment and, if pregnant through 6 weeks post-delivery, up to 66 weeks|||number of multiples|||Number
810412|NCT01045031|Secondary|Insulin-like Growth Factor (IGF-1)||Baseline and 5 years|||ng/mL||Standard Deviation|Mean
810413|NCT01045031|Secondary|Self Rating by Questionnaires|The following self rating scales were used: WHO-5 Quality of Life Assessment (Braeher, E., Muehlan, H., Albani, C., & Schmidt, S. (2007). Testing and standardization of the German version of the EUROHIS-QOL and WHO-5 quality-of life-indices. Diagnostica, 53(2), 83-96.). Range: 0 - 25, higher scores indicate better quality of life.|Baseline and 5 years|Study population (Baseline and follow-up)||point scale||Standard Deviation|Mean
810414|NCT01045031|Primary|Brain-derived Neurotrophic Factor (BDNF)||Baseline and 5 years|Baseline values differ from published data, since BDNF-levels had to be re-assessed from banked material due to a manufacturer-based change of the analysis kit.||ng/mL||Standard Deviation|Mean
810415|NCT01045031|Primary|the Proportion of Subjects, Who Will Develop Mild Cognitive Impairment|Hypothesis will be tested at the second follow-up examinations.|10 years||12/2019||||
810416|NCT01045057|Secondary|Postoperative Results|Patients were followed-up one month after surgery.Patients with secondary punctures filled out a questionnaire.|1 month|Only patients with secondary puncture filled out questionnaire. Seven patients had secondary puncture. One patient refused to fill out questionnaire. Six patients remained. Analysis per protocol.||Number of patients|||Number
810417|NCT01045057|Secondary|Cost Effectiveness Calculation|"cost effectiveness of the new tool set is compared to that of the set that would have been used in the absence of the new puncture set.
Measurements are: time needed to perform procedure"|1 month|Number subjects based on optimal minimax two-stage design. Based on power calculation, 26 patients should be included. In first stage, 20/23 successful insertions are needed to continue. In second stage, with 23/26 successful insertions device is considered safe. Analysis is per protocol.||seconds||Standard Deviation|Mean
810418|NCT01045057|Secondary|Satisfaction of Physician|Satisfaction of the physicians with the new tools was investigated by asking them which tool set they prefer: the new set from the study or the set they would have normally used.|1 month|Number subjects based on optimal minimax two-stage design. Based on power calculation, 26 patients should be included. In first stage, 20/23 successful insertions are needed to continue. In second stage, with 23/26 successful insertions device is considered safe. Analysis is per protocol.||Number of times new set was preferred|||Number
810419|NCT01045057|Primary|Success Rate of Procedure|As successful counted all successful procedures in which the tracheal flange of the voice prosthesis unfolded completely without help of additional tools. A success rate of 80% and higher was considered acceptable.|immediate observation during surgery|Number subjects based on optimal minimax two-stage design. Based on power calculation, 26 patients should be included. In first stage, 20/23 successful insertions are needed to continue. In second stage, with 23/26 successful insertions device is considered safe. Analysis is per protocol.||Nr part. with succesful insertions|||Number
810420|NCT01045096|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to 24 Hours Post-dose (AUC(0-24))|AUC(0-24) is measure of area under the curve over the dosing interval (tau), where tau is the length of the dosing interval (24 hours), calculated using the linear trapezoidal rule. Pharmacokinetic parameters were derived using noncompartmental methods from the plasma concentrations of dexlansoprazole.|Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules.|Pharmacokinetic set included all participants with at least one estimable PK parameter for dexlansoprazole on Day 7.||ng*hr/mL||Standard Deviation|Mean
810421|NCT01045096|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration (AUC(0-tlqc))|AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (tlqc), calculated using the linear trapezoidal rule. Pharmacokinetic parameters were derived using noncompartmental methods from the plasma concentrations of dexlansoprazole.|Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules.|Pharmacokinetic set included all participants with at least one estimable PK parameter for dexlansoprazole on Day 7.||ng*hr/mL||Standard Deviation|Mean
810422|NCT01045096|Primary|The Peak Plasma Concentration (Cmax)|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. Pharmacokinetic parameters were derived using noncompartmental methods from the plasma concentrations of dexlansoprazole.|Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules.|Pharmacokinetic set included all participants with at least one estimable PK parameter for dexlansoprazole on Day 7.||ng/mL||Standard Deviation|Mean
810458|NCT01045551|Secondary|Change in Physician 7 Point Global Assessment From Baseline to Week 12|The Physician Global 7-point Assessment. Scale range: 0-7. 0 = clear, 1 = minimal, 2 = mild, 3 = mild to moderate, 4= moderate, 5= moderate to severe, 6 = severe. 0 is a better outcome, 6 is a worse outcome. No subscales were used.|Baseline, week 12|||units on a scale||Standard Deviation|Mean
810423|NCT01045096|Other Pre-specified|Dose-normalized Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to 24 Hours Post-dose (AUC(0-24)/Dose)|AUC(0-24) is measure of area under the curve over the dosing interval (tau), where tau is the length of the dosing interval (24 hours), calculated using the linear trapezoidal rule and normalized by dose. Pharmacokinetic parameters were derived using noncompartmental methods from the plasma concentrations of dexlansoprazole.|Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules.|Pharmacokinetic set included all participants with at least one estimable PK parameter for dexlansoprazole on Day 7.||ng*hr/mL/mg||Standard Deviation|Mean
810424|NCT01045096|Other Pre-specified|Dose-normalized Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration (AUC(0-tlqc)/Dose)|AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (tlqc), calculated using the linear trapezoidal rule, and normalized by dose. Pharmacokinetic parameters were derived using noncompartmental methods from the plasma concentrations of dexlansoprazole.|Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules.|Pharmacokinetic set included all participants with at least one estimable PK parameter for dexlansoprazole on Day 7.||ng*hr/mL/mg||Standard Deviation|Mean
810425|NCT01045096|Other Pre-specified|Dose-normalized Peak Plasma Concentration (Cmax/Dose)|Maximum observed plasma concentration (the peak plasma concentration of a drug after administration), normalized by dose. Pharmacokinetic parameters were derived using noncompartmental methods from the plasma concentrations of dexlansoprazole.|Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules.|Pharmacokinetic set included all participants with at least one estimable PK parameter for dexlansoprazole on Day 7.||ng/mL/mg||Standard Deviation|Mean
810426|NCT01045096|Primary|Time to Reach the Peak Plasma Concentration (Tmax)|Time to reach the maximum plasma concentration (Cmax) of Dexlansoprazole, equal to time (hours) to Cmax, as observed on Day 7. Pharmacokinetic parameters were derived using noncompartmental methods from the plasma concentrations of dexlansoprazole.|Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules.|Pharmacokinetic (PK) set included all participants with at least one estimable PK parameter for dexlansoprazole on Day 7.||hours||Standard Deviation|Mean
810427|NCT01045122|Primary|Respiratory Disturbance Index|respiratory events (apneas, hypopneas) per hour|during infusion of study drugs|Per protocol||events per hour||Standard Deviation|Mean
810428|NCT01045161|Secondary|Part B: Peak FEV1|Change from Baseline in Peak FEV1 (L) at Week 52, Last Observation Carried Forward (LOCF)|Change from baseline (Week 0) to 52 Weeks|A total of 544 patients were randomized, with 542 in the Part A Safety population. Of the 454 patients who completed Part A, 448 patients continued into Part B, receiving at least 1 dose of open-label treatment, were included in the Part B Safety Population. Of these patients, 405 had a baseline and postbaseline assessment for the ITT Population.||L||Standard Error|Least Squares Mean
810429|NCT01045161|Primary|Part B: Morning Predose (Trough) FEV1|Change from Baseline in Morning Pre-dose (trough) Forced Expiratory Volume in 1 Second (FEV1) at Week 52, Lost Observation Carried Forward (LOCF)|Change from baseline (Week 0) to 52 Weeks|A total of 544 patients were randomized, with 542 in the Part A Safety population. Of the 454 patients who completed Part A, 448 patients continued into Part B, receiving at least 1 dose of open-label treatment, were included in the Part B Safety Population. Of these patients, 405 had a baseline and postbaseline assessment for the ITT Population.||L||Standard Deviation|Mean
810430|NCT01045161|Secondary|Part A: Peak Forced Expiratory Volume in 1 Second (FEV1)|Change from baseline in peak FEV1 at week 12, Last Observation Carried Forward (LOCF)|Change from baseline (Week 0) to Week 12|Of 544 patients randomized, 542 patients received at least 1 dose of double-blind treatment and were included in the Safety Population. Of these patients, 541 had a baseline and at least 1 postbaseline FEV1 assessment and qualified for the Intent to Treat (ITT) Population.||L||Standard Error|Least Squares Mean
810431|NCT01045161|Primary|Part A: Morning Predose (Trough) Forced Expiratory Volume in 1 Second (FEV1)|Change from baseline in Trough forced expiratory volume in 1 second before the morning dose of aclidinium bromide, Last Observation Carried Forward (LOCF)|Change from baseline (Week 0) to Week 12|Of 544 patients randomized, 542 patients received at least 1 dose of double-blind treatment and were included in the Safety Population. Of these patients, 541 had a baseline and at least 1 postbaseline FEV1 assessment and qualified for the Intent to Treat (ITT) Population.||L||Standard Error|Least Squares Mean
810432|NCT01045187|Secondary|Assess Occurence Rate of Toxicities||through 3 month follow up post treatment||||||
810433|NCT01045187|Secondary|Assess Acute Safety Outcomes in Patients During and After Vaginal Cuff Brachytherapy Treatment With the Axxent Electronic Brachytherapy System as Incorporated in to the Physician's Current Standard of Practice||through 3 month post treatment||||||
810434|NCT01045187|Primary|Assess Number of Patients Who Were Able to Complete Treatment Delivery Using the Axxent Electronic Brachytherapy System||through completion of radiation therapy|||Participants|||Number
810435|NCT01045265|Secondary|Semen to Plasma Distribution of Raltegravir|Determine the variability in the penetration of raltegravir into the seminal compartment over the raltegravir dosing period.|6 months|||ratio||Inter-Quartile Range|Median
810436|NCT01045265|Secondary|Seminal Distribution of Raltegravir|Determine the area under the concentration time curve of raltegravir in semen.|6 months|||h mg/l||Inter-Quartile Range|Median
810437|NCT01045265|Secondary|Semen to Plasma Raltegravir Concentrations|Determine the extent of raltegravir penetration into semen by obtaining semen to plasma ratios across the dosing interval.|6 months|||ratio||Inter-Quartile Range|Median
810438|NCT01045265|Primary|Seminal Concentrations of Raltegravir.|Determine if concentrations of raltegravir in semen exceed the 50% and 95% inhibitory concentrations of HIV during the dosing interval.|6 months|||mg/l||Inter-Quartile Range|Median
810459|NCT01045551|Primary|Change From Baseline in the Total Number of Papulopustular Lesions at Week 12|Papule and pustule count consisted of direct measurement of the number of papules/pustules on the face. Papule and pustule count, compared between baseline and end of treatment Week 12 was calculated|Baseline to Week 12|||papule count||Standard Deviation|Mean
810461|NCT01051323|Primary|Number of Participants Satisfied With Treatment at Final Visit|Participants were asked to rate their satisfaction with methoxy polyethyleneglycol-epoetin beta treatment at final visit. Participants' responses were “very satisfied”, “satisfied”, “undecided”, or “not satisfied”. Data for this outcome measure was reported for overall participants.|Month 12 or early discontinuation|FAS||participants|||Number
810439|NCT01045421|Secondary|Phase 2: Relationship Between Clinical Response and Molecular Markers of Response|In SCLC,chemo-sensitive/resistant population were analyzed;in breast cancers,ER2 and ER2 status were analyzed.HR+ =estrogen receptor-positive or progesterone receptor-positive. HER+ =human epidermal growth factor receptor 2 (HER2). Triple negative =negative for estrogen receptors, progesterone receptors, and HER2.Clinical response according to RECIST version 1.1. CR:complete disappearance of all target lesions,non-target disease,except nodal disease;all nodes decrease to normal (short axis <10 mm);no new lesions. PR:>=30% decrease under baseline of the sum of diameters of all target lesions (SLD);short axis was used in the sum for target nodes,longest diameter used in the sum for all other target lesions;no unequivocal progression of non-target disease;no new lesions. Progressive Disease (PD): >=20% rise in SLD from the smallest value on study;unequivocal progression of existing non-target lesions. Stable Disease (SD):Neither sufficient shrinkage for PR nor sufficient increase for PD.|12 months|Response-Evaluable population. Data is reported only for SCLC and breast cancer cohorts becuase these cohorts showed clinical meaningful single agent activity, thus subgroup analysis were done to assess whether a particular subgroup of participants was more or less responsive to alisertib. Rest of the cohorts did not show meaningful activity.||percentage of participants||95% Confidence Interval|Number
810440|NCT01045421|Secondary|Phase 1: Steady State Oral Clearance (CLss/F) for Alisertib|CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided AUC(0-tau), expressed in liter per hour (L/hr).|Day 7: predose, 30 minutes, 1, 2, 3, 4, 6, 8, and 12 hours postdose|PK-Evaluable population included all participants who had sufficient dosing data and alisertib concentration-time data to permit calculation of alisertib PK parameters in Phase 1 where Day 7 assessment was available.||L/hr||Geometric Coefficient of Variation|Geometric Mean
810441|NCT01045421|Secondary|Phase 1: Peak to Trough Ratio for Alisertib|Peak to trough ratio was estimated as a ratio of Cmax at Day 7 and the minimum observed plasma concentration (Ctrough) of alisertib at Day 7. Cmax is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. Ctrough is the minimum plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Day 7: predose, 30 minutes, 1, 2, 3, 4, 6, 8, and 12 hours postdose|PK-Evaluable population included all participants who had sufficient dosing data and alisertib concentration-time data to permit calculation of alisertib PK parameters in Phase 1 where Days 1 and 7 assessment were available.||ratio||Standard Deviation|Mean
810442|NCT01045421|Secondary|Phase 1: Rac- Accumulation Ratio for Alisertib|Rac was estimated as a ratio of AUC (0-tau) at Day 7 and AUC (0-tau) at Day 1. Area under the plasma concentration-time curve during a dosing interval, where tau is the length of the dosing interval.|Days 1 and 7: predose, 30 minutes, 1, 2, 3, 4, 6, 8, and 12 hours postdose|PK-Evaluable population included all participants who had sufficient dosing data and alisertib concentration-time data to permit calculation of alisertib PK parameters in Phase 1 where Days 1 and 7 assessment were available.||ratio||Standard Deviation|Mean
810443|NCT01045421|Secondary|Phase 1: Terminal Phase Elimination Half-life (T1/2) for Alisertib|Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.|Day 7: predose, 30 minutes, 1, 2, 3, 4, 6, 8, and 12 hours postdose|PK-Evaluable population included all participants who had sufficient dosing data and alisertib concentration-time data to permit calculation of alisertib PK parameters in Phase 1 where Day 7 assessment was available.||hours||Standard Deviation|Mean
810444|NCT01045421|Secondary|Phase 1: AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for Alisertib|Area under the plasma concentration-time curve during a dosing interval, where tau is the length of the dosing interval.|Days 1 and 7: predose, 30 minutes, 1, 2, 3, 4, 6, 8, and 12 hours postdose|PK-Evaluable population included all participants who had sufficient dosing data and alisertib concentration-time data to permit calculation of alisertib PK parameters in Phase 1 where Days 1 and 7 assessment were available.||nanomole*hour (nM*hr)||Geometric Coefficient of Variation|Geometric Mean
810445|NCT01045421|Secondary|Phase 1: Tmax- Time to Reach the Maximum Plasma Concentration (Cmax) for Alisertib|Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.|Days 1 and 7: predose, 30 minutes, 1, 2, 3, 4, 6, 8, and 12 hours postdose|PK-Evaluable population included all participants who had sufficient dosing data and alisertib concentration-time data to permit calculation of alisertib PK parameters in Phase 1 where Day 1 and Day 7 assessment were available.||hours||Full Range|Median
810446|NCT01045421|Secondary|Phase 1: Cmax- Maximum Observed Plasma Concentration for Alisertib|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Days 1 and 7: predose, 30 minutes, 1, 2, 3, 4, 6, 8, and 12 hours post-dose|Pharmacokinetic (PK)-Evaluable population included all participants who had sufficient dosing data and alisertib concentration-time data to permit calculation of alisertib PK parameters in Phase 1 where Days 1 and 7 assessment were available.||nanomole (nM)||Geometric Coefficient of Variation|Geometric Mean
810447|NCT01045421|Secondary|Phase 2: Number of Participants Reporting One or More Treatment-emergent Adverse Events and Serious Adverse Events|An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event.|Baseline up to 30 days after the last dose of study drug|Safety population included all participants who received any amount of alisertib.||participants|||Number
810460|NCT01051323|Secondary|Average Methoxy Polyethylene Glycol-epoetin Beta Dose|Average methoxy polyethylene glycol-epoetin beta dose per application is presented by study month. Mean values were taken when more than 1 application was documented for a participant during the time period considered. Data for this outcome measure was reported for overall participants.|Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12|FAS. N (number of participants analyzed) = participants evaluable for this measure. n = participants with methoxy polyethylene glycol-epoetin beta dose values during each timepoint.||mcg||Standard Deviation|Mean
810448|NCT01045421|Secondary|Phase 2: Duration of Response (DOR)|Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response=(the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1). CR: complete disappearance of all target lesions and non-target disease, except nodal disease; all nodes decreased to normal; no new lesions. PR: >=30% decrease under baseline of the sum of diameters of all target lesions; no unequivocal progression of non-target disease; no new lesions. Tumor progression: >=20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study); absolute increase of >=5 mm; appearance of >=1 new lesions is also considered progression. DOR calculated for the subgroup of participants with objective response.|Baseline up to Week 50|Included a subset of response-evaluable population who had objective tumor response.||days||95% Confidence Interval|Median
810449|NCT01045421|Secondary|Phase 2: Time to Disease Progression (TTP)|Time in days from start of study treatment to first documentation of objective tumor progression. Tumor progression as per RECIST 1.1 was defined as at least 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1or more new lesions is also considered progression.|Baseline until disease progression, assessed every 2 cycles up to end of study (up to 50 cycles)|Safety population included all participants who received any amount of alisertib.||days||95% Confidence Interval|Median
810450|NCT01045421|Secondary|Phase 2: Progression-free Survival (PFS)|PFS was defined as the time from randomization (or the first dose of study treatment for non-randomized studies) to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first. Tumor progression as per RECIST 1.1 was defined as at least 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1or more new lesions is also considered progression.|Baseline until progressive disease, assessed every 2 cycles up to end of study (up to 50 cycles)|Safety population included all participants who received any amount of alisertib.||days||95% Confidence Interval|Median
810451|NCT01045421|Primary|Phase 2: Percentage of Participants With Objective Response|Percentage of participants with objective response based assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST). CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than [<] 10 millimeter [mm]). No new lesions. PR was defined as greater than or equal to (>=) 30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.|Baseline until complete response or partial response, assessed every 2 cycles up to end of study (up to 50 cycles)|Response-Evaluable population included all participants with measurable disease who received at least 1 dose of alisertib and had at least 1 post-baseline response assessment.||percentage of participants||95% Confidence Interval|Number
810452|NCT01045421|Primary|Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs)|Toxicity according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0. DLT defined as any of the following considered related to alisertib by investigator: Grade 4 neutropenia (absolute neutrophil count <500 cells/cubic meter [cells/mm^3]) for >7 days; Grade 4 neutropenia with coincident fever; Grade 4 thrombocytopenia (platelets <25,000 cells/mm3) for >7 days; Platelet count <10,000 cells/mm3; Grade 3 thrombocytopenia with clinically significant bleeding; Delay in initiation of the subsequent therapy cycle by >7 days due to treatment-related toxicity; >=Grade 3 nonhematological toxicity except >=Grade 3 nausea/emesis occurred in the absence of optimal antiemetic therapy; >=Grade 3 diarrhea occurred in the absence of optimal supportive therapy with loperamide/comparable antidiarrheal; Grade 3 fatigue for <1 week; Other Grade 3 nonhematological toxicity that could be safely, reliably controlled to <=Grade 2 with appropriate treatment.|Phase 1: Cycle 1 Day 1 to Cycle 2 Day 21|DLT-Evaluable population: all participants in the Phase 1 portion of the study who either experienced DLT during Cycle 1 or completed at least 85% of the planned doses of alisertib and had sufficient follow-up data to allow the investigators and sponsor to determine whether DLT occurred.||participants|||Number
810453|NCT01045447|Secondary|Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)|Mean of SMPG after 26 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast.|Week 26|The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF). Two subjects withdrew prior to exposure to trial drug, hence excluded from the FAS. For 23 subjects all 9-point SMPG values were missing.||mmol/L||Standard Deviation|Mean
810454|NCT01045447|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Change from baseline in HbA1c after 26 weeks of treatment.|Week 0, Week 26|The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF). Two subjects withdrew prior to exposure to trial drug, hence excluded from the FAS.||percentage of glycosylated haemoglobin||Standard Deviation|Mean
810455|NCT01045551|Secondary|Change From Visit 8 (Week 12) in Telangiectasia Count at Visit 9 (Week 16)||Week 12, Week 16|||telangiectasia count||Standard Error|Mean
810456|NCT01045551|Secondary|Change From Baseline in Telangiectasia Count at Visit 8 (Week 12)|physician count of telangiectasias on the face at visit 1 (baseline) compared to at visit 8 (week 12)|Baseline, Week 12|||telangiectasia count||Standard Error|Mean
810457|NCT01045551|Secondary|Change From Baseline in Erythema Rating Visit 8 (Week 12)|The change in the Physician Overall Erythema Severity. Scale range 0 - 3. 0 = none/absent, 1 = mild, 2 = moderate, 3 = severe. 0 is considered a better outcome, 3 is considered a worse outcome.|Baseline, Week 12|||units on a scale||Standard Deviation|Mean
810522|NCT01052480|Secondary|Duration of Stay in ICU|Days that a participant spent in ICU. Multiple ICU admissions are summed up.|Measured from Day 0 through Day 28|The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza.||days||Inter-Quartile Range|Median
810462|NCT01051323|Primary|Number of Participants Who Switched to Other Erythropoiesis Stimulating Agents (ESA)-Therapy|Number of participants who switched to other ESA therapies including Aranesp, Biopoin, Biosimilar, Erypo, and NeoRecormon is presented. Data for this outcome measure was reported for overall participants.|Month 12 or early discontinuation|FAS. N (number of participants analyzed) = participants evaluable for this measure.||participants|||Number
810463|NCT01051323|Primary|Number of Participants With Reasons for Discontinuation of Methoxy Polyethyleneglycol-epoetin Beta Treatment After Study Completion|At final visit, physicians were asked to state the reasons in case of discontinuation of treatment with methoxy polyethyleneglycol-epoetin beta. The same participant could have discontinued treatment due to multiple reasons. Data for this outcome measure was reported for overall participants.|Month 12 or early discontinuation|FAS. N (number of participants analyzed) = participants evaluable for this measure.||participants|||Number
810464|NCT01051323|Primary|Number of Participants Who Continued Treatment With Methoxy Polyethyleneglycol-epoetin Beta After Study Completion|"At final visit, physicians were asked to answer (yes or no) the question, whether they would continue treatment with methoxy polyethyleneglycol-epoetin beta treatment after study completion. Data for this outcome measure was reported for overall participants."|Month 12 or early discontinuation|FAS||participants|||Number
810465|NCT01051323|Primary|Number of Physicians Satisfied With Treatment at Final Visit|Physicians were asked to rate their satisfaction with the methoxy polyethyleneglycol-epoetin beta treatment at final visit. Physicians' responses were “very satisfied”, “satisfied”, “undecided”, or “not satisfied”. One physician could analyze multiple participants but for the purpose of analysis each physician was counted as one for each analyzed participants; hence, the number of physicians (as per this assessment) was equal to the number of participants analyzed. Data for this outcome measure was reported for overall participants.|Month 12 or early discontinuation|FAS||physicians|||Number
810466|NCT01051323|Primary|C-reactive Protein (CRP) Values|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Data for this outcome measure was reported for overall participants.|Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12|FAS. N (number of participants analyzed) = participants evaluable for this measure. n = participants with C-reactive protein values at each timepoint.||mg/dL||Standard Deviation|Mean
810467|NCT01051323|Primary|Transferrin Saturation Values|Transferrin saturation (TSAT) measured as a percentage, is a medical laboratory test. It is the ratio of serum iron and total iron-binding capacity, multiplied by 100. Data for this outcome measure was reported for overall participants.|Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12|FAS. N (number of participants analyzed) = participants evaluable for this measure. n = participants with transferrin saturation values at each timepoint.||percent transferrin saturation||Standard Deviation|Mean
810468|NCT01051323|Primary|Transferrin Values|Transferrin levels were measured as milligram/deciliter (mg/dL). Data for this outcome measure was reported for overall participants.|Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12|FAS. N (number of participants analyzed) = participants evaluable for this measure. n = participants with tansferrin values at each timepoint.||mg/dL||Standard Deviation|Mean
810469|NCT01051323|Primary|Serum Iron Values|Serum iron levels were measured as microgram/deciliter (mcg/dL). Data for this outcome measure was reported for overall participants.|Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12|FAS. N (number of participants analyzed) = participants evaluable for this measure. n = participants with serum iron values at each timepoint.||mcg/dL||Standard Deviation|Mean
810470|NCT01051323|Primary|Serum Ferritin Values|Serum ferritin levels were measured as nanogram/milliliter (ng/mL). Data for this outcome measure was reported for overall participants.|Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12|FAS. N (number of participants analyzed) = participants evaluable for this measure. n = participants with serum ferritin values at each timepoint.||ng/mL||Standard Deviation|Mean
810471|NCT01051323|Primary|Maximum Intra-Individual Fluctuation of Hemoglobin Values by Predialysis/Hemodialysis, Age, and Center Size|For characterization of intra-individual fluctuations, the maximum absolute differences were derived from study period specific individual mean values. Maximum intra-individual fluctuation of hemoglobin values by predialysis/hemodialysis, age (<65 years, >=65 years), and center size (>100 participants, <=100 participants) is presented. Data for this outcome measure was reported for overall participants.|Month 0 to Month 12|FAS. N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for specified category.||g/dL||Standard Deviation|Mean
810472|NCT01051323|Primary|Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size|The percentage of participants with hemoglobin values within the pre-defined ranges (10-12 g/dL, 11-12 g/dL, and 11-13 g/dL) during Month 6 to Month 12 by dose modification (yes or no), age (<65 years, >=65 years) and center size (>100 participants, <=100 participants) is presented.|Month 6 to Month 12|FAS. n = participants evaluable for specified category for each arm group, respectively.||percentage of participants|||Number
810473|NCT01051323|Primary|Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size|The percentage of participants with hemoglobin (Hb) values within the pre-defined ranges (10–12 g/dL, 11–12 g/dL, and 11–13 g/dL) during evaluation period (Month 0 to Month 12) by dose modification (yes or no), age (<65 years, greater than or equal to [>=] 65 years) and center size (>100 participants, less than or equal to [<=] 100 participants) is presented.|Month 0 to Month 12|FAS. n = participants evaluable for specified category for each arm group, respectively.||percentage of participants|||Number
810474|NCT01051323|Primary|Percentage of Participants With at Least One Hemoglobin Value Outside the Target Range|Mean hemoglobin was calculated from measurements taken during the Evaluation Period (Month 0 to Month 12). The target hemoglobin range was 10 to 13 gram/deciliter (g/dL). Percentage of participants with at least one hemoglobin value less than (<) 10 g/dL or greater than (>) 13 g/dL during the evaluation period by predialysis/hemodialysis is presented.|Month 0 to Month 12|FAS||percentage of participants|||Number
810505|NCT01052428|Primary|Peak Early Filling Rate: Rate of Change Over Time|Peak Early Filling Rate The peak early filling rate of change is calculated from the slope of the volume during the early filling of the heart with respect to time. The higher values indicate a very healthy heart muscle and lower values are indicative of a very stiff muscle.|5 visits per Participant over 2 years (about every 6 months)|intent to treat||EDV/sec||Standard Deviation|Mean
810475|NCT01051440|Secondary|Change in Clinical Global Impressions Improvement (CGI-I) Score.|The CGI-I score indicates the clinician's overall assessment of improvement in function from one visit to the next. The single item is scored from 1 to 7 with anchor points ranging from very much improved (1) to very much worse (7). A decrease in score reflects an improvement in functional status.|week 1 and week 9|All participants who were randomized to lisdexamfetamine or placebo were included.||units on a scale|||Number
810476|NCT01051440|Secondary|Change in Clinical Global Impressions Severity (CGI-S) Score.|"The CGI-S score reflects the clinician's overall impression of the patient's functional status. The scoring for the single item ranges from 1 with an anchor of normal, not at all ill to 7 with an anchor of among the most extremely ill patients. Thus, higher scores indicate greater severity of symptoms."|baseline and week 8|All participants who were randomized to lisdexamfetamine or placebo were included.||units on a scale|||Number
810477|NCT01051440|Primary|Change in Montgomery Asberg Depression Rating Scale (MADRS) Score Over Time.|The change in MADRS score from the baseline visit to the week 8 visit is reported. The MADRS is a clinician-rated scale that consists of 10 items rated on a from 0 to 6 (maximum score of 60), with higher scores indicating greater symptom severity. An increase in score indicates a worsening of symptoms whereas a decrease indicates an improvement in symptoms.|baseline and 8 weeks|All participants randomized to lisdexamfetamine or placebo were included.||units on a scale|||Number
810478|NCT01051466|Secondary|Incidence of Suicidal Behavior and Suicidal Ideation as Measured by the Columbia Suicide Severity Rating Scale (C-SSRS)|"The C-SSRS captures the occurrence, severity, and frequency of treatment-emergent suicide-related thoughts and behaviors. Suicidal ideation is defined as a yes answer to any 1 of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Suicidal behavior is defined as a yes answer to any 1 of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Treatment-emergent outcomes were the worsening or new occurrence of suicidal behaviors or ideation during treatment compared with baseline."|Baseline through Week 12|Participants with MDD who had a baseline and at least 1 post-baseline C-SSRS assessment. Healthy participants did not have a C-SSRS assessment post baseline.||participants|||Number
810479|NCT01051466|Secondary|Hamilton Anxiety Rating Scale (HAMA)|The 14-item HAMA is used to assess the severity of anxiety. The investigator talked to the participant about their symptoms over the previous week. Each item was scored using a 5-point scale (0 = not present to 4 = very severe). Total HAMA scores could have ranged from 0 (normal) to 56 (severe).|Baseline and up to Week 12|Enrolled participants who had a baseline and at least 1 post-baseline HAMA observation. Last observation carried forward (LOCF) was utilized when calculating the Week 12 endpoint outcome.||units on a scale||Standard Deviation|Mean
810480|NCT01051466|Secondary|Patient's Global Impressions of Improvement (PGI-I) Scale|The PGI-I scale measures the participant's perception of improvement at the time of assessment compared with the start of treatment. Scores can range from 1 (very much better) to 7 (very much worse).|Baseline, up to Week 12|Enrolled MDD participants who had at least 1 post-baseline PGI-I observation. Last observation carried forward (LOCF) was utilized when calculating the Week 12 endpoint outcome. PGI-I observations were not completed for healthy participants.||units on a scale||Standard Deviation|Mean
810481|NCT01051466|Secondary|Clinical Global Impressions of Severity Scale (CGI-S)|The CGI-S measures severity of illness at the time of assessment. Scores can range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).|Baseline and up to Week 12|Enrolled participants who had baseline and at least 1 post-baseline CGI-S observation. Last observation carried forward (LOCF) was utilized when calculating the Week 12 endpoint outcome.||units on a scale||Standard Deviation|Mean
810482|NCT01051466|Secondary|Sheehan Disability Scale (SDS)|The SDS is a participant-rated questionnaire used to assess the effect of the participant's symptoms on work/school (Item 1), social life/leisure activities (Item 2), and family/home management (Item 3). Each item was rated on a visual analog scale (VAS) from 0 (not at all) to 10 (very severely). The SDS Global Functional Impairment Score (SDS Global Score) was the sum of the 3 items and could have ranged from 0 (unimpaired) to 30 (highly impaired). Higher values indicated higher functional impairment in the participant's work/social/family life.|Baseline and up to Week 12|Enrolled participants who had baseline and at least 1 post-baseline SDS observation. Last observation carried forward (LOCF) was utilized when calculating the Week 12 endpoint outcome.||units on a scale||Standard Deviation|Mean
810483|NCT01051466|Secondary|Percentage of Participants With 17-Item Hamilton Depression Rating Scale (HAMD17) Remission|HAMD17 remission is defined as a HAMD17 total score of ≤7 at Week 12 (endpoint). The HAMD17 is a standardized instrument consisting of 17 items used to measure the severity of major depressive disorder (MDD) and improvements in depression symptoms. Each item was evaluated and scored using either a 5-point scale of 0 (not present/absent) to 4 (very severe) or a 3-point scale of 0 (not present/absent) to 2 (marked). Higher scores indicated greater symptom severity. The total score was the sum of the scores from HAMD17 Items 1 through 17 and could have ranged from 0 (not at all depressed) to 52 (severely depressed). The percentage of participants with remission was calculated as the number of participants with a HAMD17 total score of ≤7 divided by the number of participants who had a HAMD17 observation at Week 12 then multiplied by 100.|Baseline, up to Week 12|Enrolled MDD participants who had a baseline and at least 1 post-baseline HAMD17 observation. Last observation carried forward (LOCF) was utilized when calculating the Week 12 endpoint outcome.||percentage of participants|||Number
810484|NCT01051466|Secondary|Percentage of Participants With 17-Item Hamilton Depression Rating Scale (HAMD17) Response|HAMD17 response is defined as a >50% reduction in HAMD17 total score from baseline. The HAMD17 is a standardized instrument consisting of 17 items used to measure the severity of major depressive disorder (MDD) and improvements in depression symptoms. Each item was evaluated and scored using either a 5-point scale of 0 (not present/absent) to 4 (very severe) or a 3-point scale of 0 (not present/absent) to 2 (marked). Higher scores indicated greater symptom severity. The total score was the sum of the scores from HAMD17 Items 1 through 17 and could have ranged from 0 (not at all depressed) to 52 (severely depressed). The percentage of participants with a HAMD17 response was calculated as the number of participants with a >50% reduction in HAMD17 total score from baseline divided by the number of participants who had a HAMD17 observation at Week 12 then multiplied by 100.|Baseline, up to Week 12|Enrolled MDD participants who had a baseline and at least 1 post-baseline HAMD17 observation. Last observation carried forward (LOCF) was utilized when calculating the Week 12 endpoint outcome.||percentage of participants|||Number
810485|NCT01051466|Secondary|17-Item Hamilton Depression Rating Scale (HAMD17)|The HAMD17 is a standardized instrument consisting of 17 items used to measure the severity of major depressive disorder (MDD) and improvements in depression symptoms. Each item was evaluated and scored using either a 5-point scale of 0 (not present/absent) to 4 (very severe) or a 3-point scale of 0 (not present/absent) to 2 (marked). Higher scores indicated greater symptom severity. The total score was the sum of the scores from HAMD17 Items 1 through 17 and could have ranged from 0 (not at all depressed) to 52 (severely depressed).|Baseline and up to Week 12|Enrolled participants who had a baseline and at least 1 post-baseline HAMD17 observation. Last observation carried forward (LOCF) was utilized when calculating the Week 12 endpoint outcome.||units on a scale||Standard Deviation|Mean
810486|NCT01051466|Secondary|Change From Baseline to 12-Week Endpoint in Proinflammatory Cytokines [Tumor Necrosis Factor Alpha (TNFα), Interleukin 1 (IL-1), and Interleukin 6 (IL-6)]|Cytokines are naturally produced and regulate responses to inflammation. Proinflammatory cytokines like TNFα, IL-1, and IL-6 increase inflammation in the body. Least squares (LS) mean was calculated using mixed-model repeated measures (MMRM) adjusted for group, visit, group-by-visit, and baseline value.|Baseline, Week 12|Enrolled participants who had baseline and at least 1 post-baseline cytokine observation (TNFα, IL-1, or IL-6), excluding 3 healthy participants who did not meet entry criteria.||picograms per milliliter (pg/mL)||Standard Error|Least Squares Mean
810487|NCT01051466|Secondary|Change From Baseline to 12-Week Endpoint in Brain-Derived Neurotrophic Factor (BDNF) and the Precursor of BDNF (proBDNF) Receptors|There is evidence that stress may decrease BDNF expression, while antidepressant treatment reverses or blocks these effects. BDNF is a protein that occurs naturally and supports the survival and growth of some nerve cells in the brain. proBDNF is a precursor of BDNF. Tropomyosin receptor kinase B (trkB) is a receptor for BDNF, and pan-neurotrophin receptor p75 (p75NTR) is a receptor for proBDNF. p75NTR was not analyzed due to technical laboratory issues. Least squares (LS) mean was calculated using mixed-model repeated measures (MMRM) adjusted for group, visit, group-by-visit, and baseline value.|Baseline, Week 12|Enrolled participants who had baseline and at least 1 post-baseline trkB observation, excluding 3 healthy participants who did not meet entry criteria. No participant was analyzed for the change from baseline in p75NTR receptors.||picograms per milligram (pg/mg)||Standard Error|Least Squares Mean
810488|NCT01051466|Secondary|Change From Baseline to 12-Week Endpoint in Brain-Derived Neurotrophic Factor (BDNF) and the Precursor of BDNF (proBDNF)|There is evidence that stress may decrease BDNF expression, while antidepressant treatment reverses or blocks these effects. BDNF is a protein that occurs naturally and supports the survival and growth of some nerve cells in the brain. proBDNF is a precursor of BDNF. Least squares (LS) mean was calculated using mixed-model repeated measures (MMRM) adjusted for group, visit, group-by-visit, and baseline value.|Baseline, Week 12|Enrolled participants who had baseline and at least 1 post-baseline BDNF or proBDNF observation, excluding 3 healthy participants who did not meet entry criteria.||nanograms per milliliter (ng/mL)||Standard Error|Least Squares Mean
810489|NCT01051466|Secondary|Gs Alpha (Gsα)-Activated Adenylyl Cyclase|Gsα is a membrane-associated protein that couples receptors for neurotransmitters like serotonin to allow them to send messages between nerve cells - a process that may be altered during depression and antidepressant treatment. Adenylyl cyclase is activated by Gsα, and when Gsα is translocated from lipid rafts it more effectively activates adenylyl cyclase. Gsα-activated adenylyl cyclase was not analyzed due to technical laboratory issues.|Baseline and Weeks 1, 8, and 12|No participants were analyzed.|||||
810490|NCT01051466|Secondary|Translocation of Gs Alpha (Gsα) From Lipid Rafts in the Cell Membranes of Red Blood Cells (RBCs), White Blood Cells (WBCs) and Platelets Compared With Baseline|Gsα is a membrane-associated protein that couples receptors for neurotransmitters like serotonin to allow them to send messages between nerve cells - a process that may be altered during depression and antidepressant treatment. Gsα localization in the cholesterol-rich (lipid rafts) and cholesterol-poor regions of cell membranes of RBCs and platelets was measured with quantitative Western blots and reported as the ratio of Gsα (absorbance units) in Triton X-100 (TX-100) over Triton X-114 (TX-114), 2 detergents that discriminate between lipid raft and non-raft membrane domains. Translocation of Gsα was measured as the change from baseline in Gsα localization. Translocation of Gsα from lipid rafts in the cell membranes of WBCs was not analyzed due to technical laboratory issues. Least squares (LS) mean was calculated using mixed-model repeated measures (MMRM) adjusted for group, visit, group-by-visit, and baseline value.|Baseline, Weeks 1, 8, and 12|Enrolled participants who had a baseline and at least 1 post-baseline Gsα localization observation, excluding 3 healthy participants who did not meet entry criteria. No participants were analyzed for the translocation of Gsα from lipid rafts in the cell membranes of WBCs.||Ratio||Standard Error|Least Squares Mean
810491|NCT01051466|Secondary|Change From Baseline to 12-Week Endpoint in Volume of Subgenual Anterior Cingulate, Amygdalae, and Hippocampus|The volume of specific brain regions is obtained using a structural magnetic resonance imaging (sMRI) procedure in which high-resolution spoiled gradient recall images are acquired in coronal brain slices. Least squares (LS) mean was calculated using mixed-model repeated measures (MMRM) adjusted for group, visit, group-by-visit, and baseline value.|Baseline, Week 12|Enrolled participants who had baseline and at least 1 post-baseline observation for the volume of specific brain regions, excluding 3 healthy participants who did not meet entry criteria.||cubic millimeters (mm^3)||Standard Error|Least Squares Mean
810492|NCT01051466|Secondary|Change From Baseline to 12-Week Endpoint in Activation [Blood Oxygenation-Level-Dependent (BOLD) Response to Implicit Processing of Sad Faces] for Each of the 3 Brain Regions|Functional magnetic resonance imaging (fMRI) is a functional neuroimaging procedure that uses MRI technology to measure brain activity by detecting associated changes in blood flow. When an area of the brain is in use, blood flow to that region increases. The activation in response to the processing of sad faces in each brain region (anterior cingulate, left amygdala and right amygdala) was measured by the percentage of signal change in BOLD response. The percentage of signal change was calculated by taking the difference between BOLD response after sad faces processing and BOLD response before sad faces processing and dividing by BOLD response before sad face processing, then multiplying by 100. BOLD signals were measured using arbitrary magnetic resonance units. Least squares (LS) mean was calculated using mixed-model repeated measures (MMRM) adjusted for group, visit, group-by-visit, and baseline value.|Baseline, Week 12|Enrolled participants who had baseline and at least 1 post-baseline activation (BOLD response) observation, excluding 3 healthy participants who did not meet entry criteria.||percentage of signal change||Standard Error|Least Squares Mean
810493|NCT01051466|Primary|Change From Baseline to 12-Week Endpoint in the Functional Magnetic Resonance Imaging (fMRI) Mean Blood Oxygenation-Level-Dependent (BOLD) Response in the Amygdalae|Functional MRI or fMRI is a functional neuroimaging procedure that uses MRI technology to measure brain activity by detecting associated changes in blood flow. When an area of the brain is in use, blood flow to that region increases. The activation in response to the processing of sad faces was measured by the percentage of signal change in BOLD response from before to after sad faces processing. The percentage of signal change was calculated by taking the difference between BOLD response after sad faces processing and BOLD response before sad faces processing and dividing by BOLD response before sad face processing, then multiplying by 100. BOLD signals were measured using arbitrary magnetic resonance units. Amygdala BOLD activation was calculated as an average between the left amygdala activation and right amygdala activation. Least squares (LS) mean was calculated using mixed-model repeated measures (MMRM) adjusted for group, visit, group-by-visit, and baseline value.|Baseline, Week 12|Enrolled participants who had baseline and at least 1 post-baseline activation (BOLD response) observation.||percentage of signal change||Standard Error|Least Squares Mean
810494|NCT01052116|Primary|Mean Change From Baseline to 24 Weeks for FEV1||24 weeks|||Liters||95% Confidence Interval|Mean
810495|NCT01052207|Secondary|Analysis of Clinical Data to Determine Correlation of OS With AI and Evaluation of OS as a Potential Biomarker.||2 years||||||
810496|NCT01052207|Secondary|Establish the OS Profile of Healthy Children to Act as Controls and Help Establish the Normal Pediatric Baseline.||2 years||||||
810497|NCT01052207|Primary|Pediatric Logistic Organ Dysfunction Score in Critically Ill Children|"Pediatric Logistic Organ Dysfunction also known as the PELOD Score is a marker of severity of illness for Critically ill children. The PELOD includes six organ dysfunctions and 12 variables.
To calculate the PELOD score, each organ dysfunction received points for the single variable associated with the most points. The minimum number that can be assigned to an organ is 0 and the maximum number of points for an organ is 20, and the maximum possible PELOD score is 71. Organ dysfunction is identified if the score for any organ system was more than 0."|1 years|PELOD scores are not calculated for healthy controls. The score was developed to assess critically ill patients only.||scores on a scale||Standard Deviation|Mean
810498|NCT01052272|Primary|Peak Early Filling Rate Normalized to EDV|The Peak Early Filling Rate Normalized to EDV is calculated from the slope of the volume during the early filling of the heart with respect to time. The higher values indicate a very healthy heart muscle and lower values are indicative of a very stiff muscle. This is a measure of LV Diastolic Function. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes.|5 visits per Participant over 2 years (about every 6 months)|intent to treat||1/sec||Standard Deviation|Mean
810499|NCT01052272|Primary|LV End Systolic Maximum Shortening (LVES Max Shortening)|By identifying three points in three different planes in the heart muscle, the maximum shortening is the average of the difference between the distance between these three points at the end of filling of the heart and the end of contraction divided by the length at the end of filling times 100. The maximum shortening is a three dimensional analysis. The higher values indicate a healthy heart. This is a measure of LV Systolic Function. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes.|5 visits per Participant over 2 years (about every 6 months)|intent to treat||percent of length at end of filling||Standard Deviation|Mean
810500|NCT01052272|Primary|Left Ventricular End Systolic Volume Indexed to Body Surface Area (LVESV/BSA)|LVESV/BSA: The end systolic volume is the blood volume of the heart at the end of contraction and is an index of the pump function of the heart. This relation to body size is more accurate in determining pathology because larger people require a larger heart blood volume. The values that are too high or too low indicate a diseased myocardium. This is a measure of LV Systolic Function. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals.|5 visits per Participant over 2 years (about every 6 months)|intent to treat||ml/m^2||Standard Deviation|Mean
810501|NCT01052272|Primary|Left Ventricular Ejection Fraction (LVEF)|LVEF is a calculation of heart pump function determined from the volume after complete filling minus the volume after complete contraction divided by the volume after complete filling. A value of 55% or greater is normal. This is a measure of LV Systolic Function. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes|5 visits per Participant over 2 years (about every 6 months)|intent to treat||percent||Standard Deviation|Mean
810502|NCT01052272|Primary|Left Ventricular End-diastolic Mass Indexed to Left Ventricular End-diastolic Volume (LVED Mass/LVEDV)|LVED Mass/LVEDV: As an indicator of heart muscle mass and heart blood volume, the mass indexed to end diastolic volume determines whether there is an adequate amount of heart muscle to pump the heart blood volume obtained from a three-dimensional analysis. The values that are too high or too low indicate a diseased myocardium. This is a measure of LV Geometry. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes.|5 visits per Participant over 2 years (about every 6 months)|intent to treat||g/ml||Standard Deviation|Mean
810503|NCT01052272|Primary|Left Ventricular End-Diastolic Radius to Wall Thickness (LVED Radius/Wall Thickness)|LVED Radius/Wall thickness As an indicator of heart muscle mass and heart volume chamber diameter, the end-diastolic radius indexed to end diastolic wall thickness determines whether there is an adequate amount of heart muscle to pump the heart blood volume obtained from a two-dimensional analysis. The values that are too high or too low indicate a diseased myocardium. This is a measure of LV Geometry. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes.|5 visits per Participant over 2 years (about every 6 months)|intent to treat||unitless||Standard Deviation|Mean
810504|NCT01052272|Primary|Left Ventricular End Diastolic Volume Indexed to Body Surface Area (LVEDV/BSA)|LVEDV/BSA: As an indicator of heart size, the blood volume of the heart is related to the body size. The relation of heart blood volume to body size is more accurate in determining pathology because larger people require a larger heart blood volume. The values that are too high or too low indicate a diseased myocardium. This is a measure of LV Diastolic Function. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals.|5 visits per Participant over 2 years (about every 6 months)|intent to treat||ml/m^2||Standard Deviation|Mean
810506|NCT01052428|Primary|Systolic Longitudinal Strain|Systolic Longitudinal Strain. By identifying two points on the heart, the strain is the difference between the distance between these two points at the end of filling of the heart and the end of contraction divided by the length at the end of filling. Thus, the measure is like the ejection fraction, however the strain is more localized to a specified segment in the heart muscle. The higher values indicate a healthy heart.|5 visits per Participant over 2 years (about every 6 months)|intent to treat||percent/%Systolic interval||Standard Deviation|Mean
810507|NCT01052428|Primary|Left Ventricular Ejection Fraction|Left Ventricular Ejection Fraction Is a calculation of heart pump function determined from the volume after complete filling minus the volume after complete contraction divided by the volume after complete filling. A value of 55% or greater is normal.|5 visits per Participant over 2 years (about every 6 months)|intent to treat||percent||Standard Deviation|Mean
810508|NCT01052428|Primary|Left Ventricular End Systolic Volume Indexed to Body Surface Area|Left Ventricular End Systolic Volume Indexed to Body Surface Area As an indicator of heart size, the blood volume of the heart is related to the body size. The end systolic volume is the blood volume of the heart at the end of contraction and is an index of the pump function of the heart. This relation to body size is more accurate in determining pathology because larger people require a larger heart blood volume. The values that are too high or too low indicate a diseased myocardium.|5 visits per Participant over 2 years (about every 6 months)|intent to treat||ml/m^2||Standard Deviation|Mean
810509|NCT01052428|Primary|Left Ventricular End-Diastolic Radius to Wall Thickness|Left Ventricular End-Diastolic Radius to Wall Thickness As an indicator of heart muscle mass and heart volume chamber diameter, the end-diastolic radius indexed to end diastolic wall thickness determines whether there is an adequate amount of heart muscle to pump the heart blood volume obtained from a two-dimensional analysis. The values that are too high or too low indicate a diseased myocardium.|5 visits per Participant over 2 years (about every 6 months)|intent to treat||unitless||Standard Deviation|Mean
810510|NCT01052428|Primary|Left Ventricular End-diastolic Mass Indexed to Left Ventricular End-diastolic Volume|Left Ventricular End-diastolic Mass Indexed to Left Ventricular End-diastolic Volume As an indicator of heart muscle mass and heart blood volume, the mass indexed to end diastolic volume determines whether there is an adequate amount of heart muscle to pump the heart blood volume obtained from a three-dimensional analysis. The values that are too high or too low indicate a diseased myocardium.|5 visits per Participant over 2 years (about every 6 months)|intent to treat||g/ml||Standard Deviation|Mean
810511|NCT01052428|Primary|Left Ventricular End Diastolic Volume Indexed to Body Surface Area|Left Ventricular End Diastolic Volume Indexed to Body Surface Area: As an indicator of heart size, the blood volume of the heart is related to the body size. The end diastolic volume is the blood volume of the heart at the end of filling, just before contraction. The relation of heart blood volume to body size is more accurate in determining pathology because larger people require a larger heart blood volume. The values that are too high or too low indicate a diseased myocardium.|5 visits per Participant over 2 years (about every 6 months)|intent to treat||ml/m^2||Standard Deviation|Mean
810512|NCT01052480|Secondary|Incidence of Spontaneous Abortion or Stillborn Fetus for Pregnant Women|Incidence of spontaneous abortion or stillborn fetus for pregnant female participants|Measured from Day 0 through Day 28|Measure was not analyzed since there was only one pregnant participant. No aggregate results were available for posting, and the individual participant-level data were not posted due to being potentially identifiable.|||||
810513|NCT01052480|Secondary|Incidence and Duration of Pre-term Labor (Defined as Labor Occurring < 36 Weeks) for Pregnant Women|Incidence and duration of pre-term labor (defined as labor occurring < 36 weeks) for pregnant female participants|Measured through Day 28|Measure was not analyzed since there was only one pregnant participant. No aggregate results were available for posting, and the individual participant-level data were not posted due to being potentially identifiable.|||||
810514|NCT01052480|Secondary|Incidence and Week of Gestation of Delivery of a Live Pre-term Infant for Pregnant Women|Incidence and week of gestation of delivery of a live pre-term infant for pregnant female participants|Measured through to Day 28|Measure was not analyzed since there was only one pregnant participant. No aggregate results were available for posting, and the individual participant-level data were not posted due to being potentially identifiable.|||||
810515|NCT01052480|Secondary|Duration of Viral Shedding < Lower Limit of Quantification (LLOQ) in Nasal Swabs|Duration of viral shedding < lower limit of quantification (LLOQ) in nasal swabs (restricted to participants with viral shedding >= LLOQ in nasal swabs at Day 0)|Measured from Day 0 through Day 28|The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza. This subset was further restricted to those participants with viral shedding >= LLOQ in nasal swabs at Day 0.||days||Inter-Quartile Range|Median
810516|NCT01052480|Secondary|Disposition Following Initial Hospitalization|"Disposition following initial hospitalization was categorized as follows: released home - home health care not required,  released home with home health care, transferred to long-term care facility, hospitalization ongoing at Day 28, deceased."|Measured from Day 0 through Day 28|The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza.||participants|||Number
810517|NCT01052480|Secondary|Duration of Mechanical Ventilation|Duration of mechanical ventilation use in days. Multiple mechanical ventilation durations are summed up.|Measured from Day 0 through Day 28|The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza.||days||Inter-Quartile Range|Median
810518|NCT01052480|Secondary|Days on Mechanical Ventilation|Time (in days) of mechanical ventilation use|Measured from Day 0 through Day 28|The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza.||days||Inter-Quartile Range|Median
810519|NCT01052480|Secondary|Incidence of Acute Respiratory Distress Syndrome (ARDS) Present|Incidence of participants with acute respiratory distress syndrome (ARDS), restricted to those without ARDS at Day 0.|Measured at Days 0, 1, 2, 4, 7, 14, 28|The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza. This population is further restricted to those participants who did not have ARDS at Day 0.||participants|||Number
810733|NCT01048606|Primary|Plasma Lipid Profile: the Apolipoproteins (Apo-AI, Apo-AII, Apo-B), Cholesterol HDL, LDL and Triglycerides Levels Will be Determined by Clinical Analyses of Blood Sample (Obtained After 12 h Fasting State)||Baseline||||||
810523|NCT01052480|Secondary|Number of ICU Admissions|Number of ICU admissions during study follow-up. The intent was to analyze any number of ICU admissions.|Measured from Day 0 through Day 28|The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza.||participants|||Number
810524|NCT01052480|Secondary|Duration of Hospitalization|Days that a participant spent at the hospital. Multiple hospitalizations are summed up.|Measured from Day 0 through Day 28|The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza.||days||Inter-Quartile Range|Median
810525|NCT01052480|Secondary|28-day Mortality|Number of deaths during study follow-up|Measured from Day 0 through Day 28|All randomized participants||participants|||Number
810526|NCT01052480|Secondary|In-hospital Mortality|Number of deaths in hospital during initial hospital admission|Measured from Day 0 through Day 28|All randomized participants||participants|||Number
810527|NCT01052480|Secondary|50 Millimeters of Mercury (mm/Hg) Improvement in PaO2/FiO2 Ratio Over Time|Number of participants with ABG done and no increase of 50 millimeters of mercury (mm/Hg) or greater in PaO2/FiO2 ratio. PaO2/FiO2 ratio was evaluated by an ABG. ABG was performed only when clinically indicated.|Measured at Days 1, 2, 4, 7, 14, 28|The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza. This subset was further restricted to those participants with a PaO2/FiO2 ratio (ABG performed) at Day 0.||participants|||Number
810528|NCT01052480|Secondary|Time to 20% Improvement in Sequential Organ Failure Assessment (SOFA) Score for Participants >= 18 Years Old and Pediatric Logistic Organ Dysfunction (PELOD) Score for Participants < 18 Years Old|The analysis is restricted to participants >= 18 years old and the SOFA score because there were very few evaluations of the PELOD score during follow-up for the participants < 18 years old. The adult population was further subset to those with a non-missing and non-zero SOFA score at Day 0; those with missing SOFA score at Day 0 did not have a starting point, and those with SOFA = 0 at Day 0 could not have an improvement.|Measured from Day 0 through Day 28|The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza. This subset was further restricted to those >= 18 years with an available (non-zero) Day 0 SOFA evaluation.||days||Inter-Quartile Range|Median
810529|NCT01052480|Secondary|Duration of Time to Resolution of All Symptoms and Fever|The assessed symptoms were nausea, vomiting, diarrhea, sore throat, headache, muscle ache, cough, and shortness of breath. Fever was defined as either a temperature > 38.0 C, or a report of a Grade 1 or higher fever as an adverse event.|Measured from Day 0 through Day 28|The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza.||days||Inter-Quartile Range|Median
810530|NCT01052480|Secondary|Duration of Time to Resolution of Fever|Fever was defined as either a temperature > 38.0 C, or a report of a Grade 1 or higher fever as an adverse event.|Measured from Day 0 through Day 28|The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza.||days||Inter-Quartile Range|Median
810531|NCT01052480|Secondary|Duration of Time to Resolution of Clinical Symptoms|The assessed clinical symptoms were nausea, vomiting, diarrhea, sore throat, headache, muscle ache, cough, and shortness of breath. Symptoms were assessed at days 0, 1, 2, 4, 7, 14, and 28.|Measured from Day 0 through Day 28|The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza.||days||Inter-Quartile Range|Median
810532|NCT01052480|Secondary|Time to Normalization of Respiratory Status (All Randomized Participants)|Normalized respiratory status is defined as room air saturation of oxygen [SaO2] greater than or equal to 93% AND respiratory rate within normal ranges.|Measured from Day 0 through Day 28|All randomized participants||days||Inter-Quartile Range|Median
810533|NCT01052480|Primary|Time to Normalization of Respiratory Status (Primary Efficacy Population)|Normalized respiratory status is defined as room air saturation of oxygen [SaO2] greater than or equal to 93% AND respiratory rate within normal ranges.|Measured from Day 0 through Day 28|The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza.||days||Inter-Quartile Range|Median
810534|NCT01052545|Primary|Number of Cases of CAUTI Inappropriately Under-treated (no Antibiotics Given)||Years 1, 2, & 3|The number of CAUTI undertreated in Arm 1=27, the number of CAUTI undertreated in Arm 2=17||cases/1,000 bed-days||95% Confidence Interval|Number
810535|NCT01052545|Secondary|Patient Level Analysis of Inappropriate Antibiotic Use|We looked at the percentage of cases of ASB (asymptomatic bacteriuria) that were inappropriately over-treated with antibiotics, and we also looked at the percentage of cases of CAUTI (catheter-associated UTI) that were not treated with antibiotics (under-treated).|three years|All patients on acute medical care wards or extended care wards during the three year study project who had a positive urine culture associated with the presence of a urinary catheter.||percentage of cases|||Number
810536|NCT01052545|Primary|Urine Cultures Ordered|Number of urine cultures collected per 1000 catheter-days for each unit|three years|For this outcome measure, the number of participants is the number of patients that had urine cultures ordered. One patient could have multiple cultures ordered. Arm 1=5209 urine cultures ordered. Arm 2=5979 urine cultures ordered. This number was standardized by bed-days. Arm 1=170345 bed-days. Arm 2=119409 bed-days.||Total ucx ordered/1,000 bed-days||95% Confidence Interval|Number
810537|NCT01052545|Secondary|Number of Catheter-days of Use Per 1000 Patient Bed Days on Each Unit||One year||||||
810538|NCT01052545|Secondary|Clinicians Acceptance of and Outcome Expectancy From Following the ABU Guidelines||one year||||||
810539|NCT01052545|Secondary|Clinicians' Awareness of and Familiarity With the ABU Guidelines.||one year||||||
810540|NCT01052545|Secondary|Number of Days Antibiotics Are Given to Treat ABU||one year||||||
810541|NCT01052545|Primary|Number of Cases of ABU That Are Treated Inappropriately With Antibiotics||Years 1, 2, & 3|The number of ASB treated in Arm 1= 180, the number of ASB treated in Arm 2= 65||cases/1,000 bed-days||95% Confidence Interval|Number
810607|NCT01053663|Secondary|Time to the Maximum Observed Plasma Concentration (Tmax) of Oseltamivir and Oseltamivir Carboxylate||Pre-dose (Hour 0), 2, 3-4, 5-7, and 10-12 hours post-dose on Day 1 and Day 2, pre-dose (Hour 0), 2 and 4 hours post-dose on Day 4|PK population. Number of participants analyzed = participants who were evaluable for this outcome, n = number of participants evaluable for specified categories.||hours||Geometric Coefficient of Variation|Geometric Mean
810542|NCT01052662|Primary|Number of Participants Who Were Estimated to Have Survived as Assessed by Survival Curve of Relapse Rate After Achieving Complete Abstinence on Week 8|Calculated survival curve from abstinence in Week 8 to first positive opioid urine screen or first reported relapse to opioid use to evaluate the effect of memantine on reducing early relapse and after rapid buprenorphine discontinuation on week 9. The last observation carried forward (LOCF) was used to perform our event survival analyses.|Weeks after buprenorphine discontinuation week 9|Participants that achieved complete abstinence by self-report that was confirmed with negative urine toxicology at week 8.||participants|||Number
810543|NCT01052662|Secondary|Treatment Retention|Treatment retention during the stabilization period weeks 1 to 8 and after buprenorphine / naloxone discontinuation weeks 9 to 13.|Weekly|Intent-treat-sample (ITT) that was inducted onto buprenorphine / naloxone and received one dose of study medication on week 2.||weeks in treatment||95% Confidence Interval|Mean
810544|NCT01052662|Primary|Change of Opioid Use From Week 1 to 13|The primary outcome variable was the change from baseline of the mean proportion of weekly opioid use assessed by self-reported days of use and/or positive urine drug screen during the previous week using the time-line followed-back method (TLFB) . A positive urine counted as 1, as did each self-reported day of use. Each participants total was divided by 8. Mean proportion by group were calculated by averaging the proportions across participants in that group.|Weekly from week 1 to 13|80 subjects intent-to-treat.||Mean Proportion of Opioid Use in Week 13||Standard Error|Mean
810545|NCT01052701|Secondary|Plasma RBV Trough Concentrations|Plasma RBV trough concentrations.|Day 56|||micrograms per milliliter||Standard Deviation|Mean
810546|NCT01052701|Primary|Ribavirin Triphosphate (RBV-TP) Intracellular Concentrations|Ribavirin Triphosphate (RBV-TP) intracellular concentrations.|Day 56|||picomoles per 10^6 cells||Standard Deviation|Mean
810547|NCT01052714|Primary|Beck Anxiety Inventory (BAI) Mean Total Score Change Per Week From Baseline to Termination|Self-reported symptom survey, score range 0 - 63, best to worst. The study groups' average score changes per week were then compared.|Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.|Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join “Usual Care then Lifestyle Balance” group to receive the Lifestyle Balance intervention.||Scores on a scale per week||Standard Error|Mean
810548|NCT01052714|Primary|Brief Psychiatric Rating Scale (BPRS) Mean Total Score Change Per Week From Baseline to Termination|Clinician-assessed symptom survey, score range 18 - 126, best to worst. The study groups' average score changes per week were then compared.|Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.|Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join “Usual Care then Lifestyle Balance” group to receive the Lifestyle Balance intervention.||Scores on a scale per week||Standard Error|Mean
810549|NCT01052714|Primary|WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 4 Score Change Per Week From Baseline to Termination|Self-reported survey of quality of life as related to respondents' environment, score range 8-40, worst to best. The study groups' average subscore changes per week were then compared.|Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.|Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join “Usual Care then Lifestyle Balance” group to receive the Lifestyle Balance intervention.||Scores on a scale per week||Standard Error|Mean
810550|NCT01052714|Primary|WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 3 Score Change Per Week From Baseline to Termination|Self-reported survey of quality of life as related to respondents' social relationships, score range 3-15, worst to best. The study groups' average subscore changes per week were then compared.|Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.|Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join “Usual Care then Lifestyle Balance” group to receive the Lifestyle Balance intervention.||Scores on a scale per week||Standard Error|Mean
810551|NCT01052714|Primary|WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 2 Score Change Per Week From Baseline to Termination|Self-reported survey of quality of life as related to respondents' psychological health, score range 6-30, worst to best. The study groups' average subscore changes per week were then compared.|Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.|Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join “Usual Care then Lifestyle Balance” group to receive the Lifestyle Balance intervention.||Scores on a scale per week||Standard Error|Mean
810552|NCT01052714|Primary|WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 1 Score Change Per Week From Baseline to Termination|Self-reported survey of quality of life as related to respondents' physical health, score range 7-35, worst to best. The study groups' average subscore changes per week were then compared.|Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.|Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join “Usual Care then Lifestyle Balance” group to receive the Lifestyle Balance intervention.||Scores on a scale per week||Standard Error|Mean
810553|NCT01052714|Primary|Mean University Rhode Island Change Assessment Scale (URICA) Total Score Change Per Week From Baseline to Termination|Self-reported survey of respondents' feelings about changing their weight problem. Total score is also called the Readiness Score, ranging from -2 to +14 (worse to better), calculated by subtracting the mean from the precontemplation responses from the summation of the means of responses to contemplation, action, and the struggling to maintain items.|Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.|Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join “Usual Care then Lifestyle Balance” group to receive the Lifestyle Balance intervention.||Scores on a scale per week||Standard Error|Mean
810554|NCT01052714|Primary|Change in Mean Total Exercise Time Per Week From Baseline to Termination|Minutes exercised assessed by dietitians using participant-recorded weekly food and exercise journals. The study groups' average change in total minutes exercised per week were then compared.|Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.|Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join “Usual Care then Lifestyle Balance” group to receive the Lifestyle Balance intervention.||Minutes per week||Standard Error|Mean
810734|NCT01048606|Primary|Body Composition: Dual-energy X-ray Absorptiometry Method||Baseline|||percent of total fat mass||Standard Deviation|Mean
810555|NCT01052714|Primary|Change in Mean Empty Calories Consumed Per Week From Baseline to Termination|Caloric intake assessed by dietitians using participant-recorded weekly food and exercise journals. The study groups' average change in empty calories consumed per week were then compared.|Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.|Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join “Usual Care then Lifestyle Balance” group to receive the Lifestyle Balance intervention.||Calories per week||Standard Error|Mean
810556|NCT01052714|Primary|Change in Mean Total Calories Consumed Per Week From Baseline to Termination|Caloric intake assessed by dietitians using participant-recorded weekly food and exercise journals. The study groups' average change in total calories consumed per week were then compared.|Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.|Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join “Usual Care then Lifestyle Balance” group to receive the Lifestyle Balance intervention.||Calories per week||Standard Error|Mean
810557|NCT01052714|Primary|Health Knowledge Quiz Mean Total Score Change Per Week From Baseline to Termination|Quiz of information covered during Lifestyle Balance classes, score range 0 - 30, worst to best. The study groups' average score changes per week were then compared.|Up to 4 observations per person,at baseline, 2 months, 6 months, and 12 months.|Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join “Usual Care then Lifestyle Balance” group to receive the Lifestyle Balance intervention.||Scores on a scale per week||Standard Error|Mean
810558|NCT01052714|Primary|Mean High-Density Lipoprotein (HDL) Cholesterol Level Change Per Week From Baseline to Termination|Results obtained through VA facility's Outpatient Lab. The study groups' average blood level changes per week were then compared.|Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months.|Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join “Usual Care then Lifestyle Balance” group to receive the Lifestyle Balance intervention.||Mg/dL per week||Standard Error|Mean
810559|NCT01052714|Primary|Mean Low-Density Lipoprotein (LDL) Cholesterol Level Change Per Week From Baseline to Termination|Results obtained through VA facility's Outpatient Lab. The study groups' average blood level changes per week were then compared.|Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months.|Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join “Usual Care then Lifestyle Balance” group to receive the Lifestyle Balance intervention.||Mg/dL per week||Standard Error|Mean
810560|NCT01052714|Primary|Mean Triglycerides Level Change Per Week From Baseline to Termination|Results obtained through VA facility's Outpatient Lab. The study groups' average blood level changes per week were then compared.|Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months.|Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join “Usual Care then Lifestyle Balance” group to receive the Lifestyle Balance intervention.||Mg/dL per week||Standard Error|Mean
810561|NCT01052714|Primary|Mean Serum Insulin Level Change Per Week From Baseline to Termination|Results obtained through VA facility’s Outpatient Lab. The study groups' average serum level changes per week were then compared.|Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months.|Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join “Usual Care then Lifestyle Balance” group to receive the Lifestyle Balance intervention.||Pmol/L per week||Standard Error|Mean
810562|NCT01052714|Primary|Mean Body Mass Index (BMI) Change Per Week From Baseline to Termination|Study personnel calculated each participant’s BMI at each visit using their weight measurement taken at that visit and their height measurement taken at baseline. The study groups' average BMI changes per week were then compared.|Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.|Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join “Usual Care then Lifestyle Balance” group to receive the Lifestyle Balance intervention.||Units on a scale per week||Standard Error|Mean
810563|NCT01052714|Primary|Mean Waist Circumference Change Per Week From Baseline to Termination|Participants' waist circumference was measured at each visit by study personnel using a measuring tape, and the study groups' average waist circumference changes per week were compared.|Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.|Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join “Usual Care then Lifestyle Balance” group to receive the Lifestyle Balance intervention.||Inches per week||Standard Error|Mean
810564|NCT01052714|Primary|Mean Weight Change Per Week From Baseline to Termination|Participants' weight was measured at each visit by study personnel using hospital scales, and the study groups' average weight changes per week were compared.|Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.|Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join “Usual Care then Lifestyle Balance” group to receive the Lifestyle Balance intervention.||Pounds per week||Standard Error|Mean
810565|NCT01052831|Secondary|Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease - Rating Scale (QUIP-RS)|The Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease–Rating Scale (QUIP-RS) was developed for use in clinical trials and added as a secondary outcome measure for assessment of change in severity of ICD symptoms, to be completed at baseline and end of study only. For the QUIP-RS, scores for each compulsive behavior range from 0 to 16, with a higher score indicating greater severity (frequency) of symptoms. Given that ICD symptoms are frequently comorbid in patients with PD, total QUIP-RS ICD scores (range from 0 to 64) were used to compare overall severity of ICD symptoms. Please note that this measure is reporting a change from baseline.|The QUIP-RS was administered at baseline and the termination visits (Visit 5, 8 weeks after baseline).|A linear mixed-effects model was used to estimate changes in QUIP-RS ICD scores from baseline to termination (visit 5, 8 weeks after baseline). Positive estimated change values represent a decrease in severity (frequency) of symptoms.||Change in points on a scale (QUIP-RS)||95% Confidence Interval|Number
810608|NCT01053663|Primary|Cmax of Oseltamivir and Oseltamivir Carboxylate on Day 4||Pre-dose (Hour 0), 2 and 4 hours post-dose on Day 4|PK population. Number of participants analyzed = participants who were evaluable for this outcome.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
810566|NCT01052831|Primary|Percentage of Participants Assessed as Very Much Improved or Much Improved Based on the Clinical Global Impression-Improvement (CGI-I) Scale|"The Clinical Global Impression-Improvement scale rates total improvement on a 7 point scale:
= Very much improved
= Much improved
= Minimally improved
= No change
= Minimally worse
= Much worse
= Very much worse
A participant scoring a 1 or 2 is considered a responder on the CGI scale. For the change in response status over time, a generalized estimating equation (GEE) model was used."|The CGI-I was administered at Visit 2 (week 2, two weeks after baseline) and Visit 5 (week 8, termination visit 8 weeks after baseline).|||percentage of responders|||Number
810567|NCT01052844|Primary|Number of Patients With CR During Delayed-onset Phase (24-120 Hours) After Administration of Chemotherapy Course 1|Complete response during delayed-onset phase was defined as the absence of any episode of nausea or vomiting and no use of rescue medication when occurring during the period from days 2 through 5 after chemotherapy|6 days|||participants|||Number
810568|NCT01052844|Primary|Number of Patients With Complete Response During Chemotherapy Course 1|The CR was defined as no emetic episodes and no nausea episodes from day 1 to day 5 (0-120h)|5 days|||participants|||Number
810569|NCT01052948|Primary|Number of Participants With All-Cause Mortality Per 10,000 Participant-Years of Follow-Up|All participants who died independent of the cause to include instantaneous death, death occurring in less than 24 hours from onset of symptoms, not otherwise explained, unattended death and other causes of ill defined morbidity and mortality. Cause of death was coded and classified as either cardiovascular or respiratory.|Up to 12 years|Per protocol.||Participants/10,000 Participant-Years|||Number
810570|NCT01052948|Primary|Number of Participants With Heart Failure Per 10,000 Participant-Years of Follow-Up|Occurrence of: unspecified acute edema of lung, heart failure, acute pulmonary heart disease, or acute cor pulmonale|Up to 12 years|Per protocol.||Participants/10,000 Participant-Years|||Number
810571|NCT01052948|Primary|Number of Participants With Fibrosis Per 10,000 Participant-Years of Follow-Up|Occurrence of: idiopathic retroperitoneal fibrosis, occlusion not otherwise specified (NOS) of ureter, diffuse (idiopathic) (interstitial) pulmonary fibrosis, Hamman-Rich syndrome, interstitial pneumonia (desquamative) (lymphoid), fibrosis of lung (atrophic; confluent; massive; perialveolar; peribronchial) chronic or unspecified, pulmonary or pleural fibrosis, abnormal communication between pericardial and pleural sacs, pleural fold anomaly, adhesive or constrictive pericarditis, pericardial fibrosis|Up to 12 years|Per protocol.||Participants/10,000 Participant-Years|||Number
810572|NCT01052948|Primary|Number of Participants With Fibrotic Valvular Heart Disease Per 10,000 Participant-Years of Follow-Up|Occurrence of: mitral stenosis with insufficiency, other unspecified mitral valve diseases, mitral or aortic valve stenosis, insufficiency, or disorders, multiple involvement of mitral and aortic valves, mitral and aortic valve diseases, unspecified, diseases of tricuspid valve, tricuspid valve disorders, specified as nonrheumatic, pulmonary valve disorders, endocarditis, valve unspecified, endomyocardial fibrosis, endocardial fibroelastosis, other primary or secondary cardiomyopathies, cardiomyopathy, functional and undiagnosed cardiac murmurs, other abnormal heart sounds.|Up to 12 years|Per protocol.||Participants/10,000 Participant-Years|||Number
810573|NCT01053000|Primary|Change in Lesion Counts in 25 cm2 Target Area Relative to Baseline.||12 weeks|||lesions||Standard Deviation|Mean
810574|NCT01053078|Secondary|Rates of Hypoglycemia||1 month||||||
810575|NCT01053078|Primary|Cerebral Blood Flow||1 month|||percentage of signal intensity change||Standard Deviation|Mean
810576|NCT01053156|Secondary|VAS Categorized by Behavior: Other|A VAS is used to represent a caregiver’s assessment of given behaviors, which were chosen by the parents. Caregivers marked a 10 cm horizontal line representing a visual continuum of each behavior from “worst behavior” to “behavior not a problem.” Greater values indicate greater improvement. This measure represents the least squares mean of all behaviors having to do with other behaviors that were not able to be categorized.|Baseline, 3 months, 6 months|In this ad hoc analysis, the various behaviors captured on the VAS were categorized and any behaviors not falling into the other categories were placed into this category. As not every caregiver named a behavior unrelated to the other categories, this number is less than the number of participants.||units on a scale||Standard Error|Least Squares Mean
810577|NCT01053156|Secondary|VAS Categorized by Behavior:Language/ Cognition|A VAS is used to represent a caregiver’s assessment of given behaviors, which were chosen by the parents. Caregivers marked a 10 cm horizontal line representing a visual continuum of each behavior from “worst behavior” to “behavior not a problem.” Greater values indicate greater improvement. This measure represents the least squares mean of all behaviors having to do with language or cognitive symptoms.|Baseline, 3 months, 6 months|In this ad hoc analysis, the various behaviors captured on the VAS were categorized and any behaviors regarding language or cognition symptoms were placed into this category. As not every caregiver named a behavior related to language or cognition, this number is less than the number of participants.||units on a scale||Standard Error|Least Squares Mean
810578|NCT01053156|Secondary|VAS Categorized by Behavior:Anxiety/ Mood|A VAS is used to represent a caregiver’s assessment of given behaviors, which were chosen by the parents. Caregivers marked a 10 cm horizontal line representing a visual continuum of each behavior from “worst behavior” to “behavior not a problem.” Greater values indicate greater improvement. This measure represents the least squares mean of all behaviors having to do with anxiety or mood related behaviors.|Baseline, 3 months, 6 months|In this ad hoc analysis, the various behaviors captured on the VAS were categorized and any behaviors regarding anxiety or mood symptoms were placed into this category. As not every caregiver named a behavior related to anxiety or mood, this number is less than the number of participants.||units on a scale||Standard Error|Least Squares Mean
810579|NCT01053156|Secondary|VAS Categorized by Behavior: Aggression/ ADHD|A VAS is used to represent a caregiver’s assessment of given behaviors, which were chosen by the parents. Caregivers marked a 10 cm horizontal line representing a visual continuum of each behavior from “worst behavior” to “behavior not a problem.” Greater values indicate greater improvement. This measure represents the least squares mean of all behaviors having to do with aggression or ADHD behaviors.|Baseline, 3 months, 6 months|In this ad hoc analysis, the various behaviors captured on the VAS were categorized and any behaviors regarding ADHD or Aggression symptoms were placed into this category. As not every caregiver named a behavior related to ADHD or aggression, this number is less than the number of participants.||units on a scale||Standard Error|Least Squares Mean
831849|NCT01243320|Primary|Change In Total Bilirubin Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days|||mg/dL||95% Confidence Interval|Mean
810580|NCT01053156|Secondary|Visual Analogue Scale Behavior 3- VAS3|A VAS is used to represent a caregiver’s assessment of given behaviors, which were chosen by the parents. Caregivers marked a 10 cm horizontal line representing a visual continuum of each behavior from “worst behavior” to “behavior not a problem.” Greater values indicate greater improvement. This measure represents the third behavior that caregivers noted, out of three.|Baseline, 3 months, 6 months|This behavior was not provided by all of the participating caregivers, and so the number is less than the participants analyzed for other measures.||units on a scale||Standard Error|Least Squares Mean
810581|NCT01053156|Secondary|Aberrant Behavior Checklist-Community Edition (ABC-C)Composite Score|The ABC-C composite scores were used to quantify the severity of a patient’s behaviors. A composite score consists of subscale scores including Irritability and Agitation, Lethargy and Social Withdrawal, Stereotypic Behavior, Hyperactivity and Noncompliance, and Inappropriate Speech. The composite score may range from 0-174. Lower scores indicate improvement.|Baseline, 3 months, and 6 months|||units on a scale||Standard Error|Least Squares Mean
810582|NCT01053156|Secondary|Vineland Adaptive Behavior Scale-II (VABS-II)Adaptive Behavior Composite Score|The VABS-II Adaptive Behavior Composite Score was used to assess adaptive skills. An Adaptive Behavior Composite Score may range from 20-160 with an average of 100 with a standard deviation of 15. Higher scores show improvement.|Baseline, 3 months, and 6 months|||units on a scale||Standard Error|Least Squares Mean
810583|NCT01053156|Secondary|Expressive Vocabulary Test-2|The EVT-2 standard score assesses language development through a participant’s one word synonym response to visual stimuli. Standard scores range from 20-160. A standard score of 100 is average, with a 15 point standard deviation. Higher values represent a better outcome.|Baseline, 3 months and 6 months|||units on a scale||Standard Error|Least Squares Mean
810584|NCT01053156|Secondary|Visual Analogue Scale- Behaviors 2|A VAS is used to represent a caregiver’s assessment of given behaviors, which were chosen by the parents. Caregivers marked a 10 cm horizontal line representing a visual continuum of each behavior from “worst behavior” to “behavior not a problem.” Greater values indicate greater improvement. This measure represents the second behavior that the caregivers noted, out of three.|Baseline, 3 months, 6 months|||units on a scale||Standard Error|Least Squares Mean
810585|NCT01053156|Primary|Visual Analogue Scale- Behavior 1|A VAS is used to represent a caregiver’s assessment of given behaviors, which were chosen by the parents. Caregivers marked a 10 cm horizontal line representing a visual continuum of each behavior from “worst behavior” to “behavior not a problem.” Greater values indicate greater improvement. This measure represents the first behavior that the caregivers noted, out of three.|Baseline, 3 months, 6 months|Any participant who completed at least the first arm of the trial were included in the intention to treat analysis||units on a scale||Standard Error|Least Squares Mean
810586|NCT01053156|Primary|Clinical Global Impression Scale (CGI)|The CGI-I utilizes history from primary caregivers and incorporates it into a seven step clinical rating for follow up throughout treatment, from 1 “very much improved” to 7 “very much worse”. Lower scores indicate more improvement. Scores were obtained post treatments. Scores from when the patients were on minocycline either first or second were combined and averaged to determine a least squares mean and placebo scores were obtained in the same manner.|3 months (post first treatment) and 6 months (post second treatment)|Any participant who completed at least the first arm of the trial were included in the intention to treat analysis||units on a scale||Standard Error|Least Squares Mean
810587|NCT01053247|Secondary|The Mean Change From Baseline in the Total Individual Clinical Signs and Symptoms Per Body Region, the Mean Change From Baseline in Pruritus and Mean Change From Baseline in the Percentage Total Body Surface Affected (%BSA).||2 weeks||||||
810588|NCT01053247|Primary|Incidence of Success Based on the Investigator's Global Evaluation at the End of Treatment||2 weeks|||participants|||Number
810589|NCT01053312|Secondary|Quantitative Estimates of Amyloid Levels ( Percent % Plaque Load) for the Following 7 Subjects|Using the Precent area of Plaque values from the Primary Anaylsis, determine the association between cerebral cortical uptake of [18F] flutemetamol (as contralateral, ipsilateral, and composite SUVR values) and Immunohistochemical and histochemical-based estimates of amyloid.|Post-contrast Administration|Using the Precent area of Plaque values from the Primary Anaylsis, determine the association between cerebral cortical uptake of [18F] flutemetamol (as contralateral, ipsilateral, and composite SUVR values) and Immunohistochemical and histochemical-based estimates of amyloid.||Percentage of Plaque|||Number
810590|NCT01053312|Primary|Comparsion Between Brain Uptake of [18F] Flutemetamol Amyloid Level From Immunohistochemistry Assay and a Stained Biopsy Tissue Specimen.|This was an amyloid level estimate measured by Immunohistochemistry assay to determine the percentage of plaque area for mAb NAB228. The Immuno-histo chemical reagent was monoclonal antibody (mAB) NAB228. This is a percentage of the area of the biopsy tissue specimen that stains positive for amyloid using NAB228.|Post-contrast administration|||Percent plaque area|||Number
810591|NCT01053312|Primary|Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained.|Radiotracers have enabled the in-vivo imaging of amyloid-beta plaques in the brain, one of the histopathologic hallmarks of Alzheimer's disease (AD). Standardized uptake value ratio SUVR)is the quantitive measure of specific tracer uptake, normalized for the non-specific mean uptake in a reference region. SUVR is calculated as SUV_voi/SUV_ref with SUV being the integrated activity over a given time period for the volume of interest (SUV_voi) or reference region (SUV_ref). VOI means volume of interest and REF means reference region.|Post-contrast administration|||Standard Uptake Value Ratio (SUVR)|||Number
810592|NCT01053429|Other Pre-specified|Change From Baseline in Drug Attitude Inventory (DAI-10) - Improvement|DAI-10: a 10-item scale to assess how the attitude of participants with schizophrenia toward their medications may affect compliance. Respondents indicate 'true' or 'false' for each item. An overall calculated score ranges from -10 to 10, where a positive score indicates a positive subjective response (compliant); a negative score indicates non-compliance.|Baseline up to Week 8|Safety analysis set. It was recommended to use the optional DAI-10 tool to gather additional information for the improvement score under usual practice. The optional DAI-10 tool was not used during the study.||participants|||Number
810609|NCT01053663|Primary|Cmax of Oseltamivir and Oseltamivir Carboxylate on Day 2||Pre-dose (Hour 0), 2, 3-4, 5-7, and 10-12 hours post-dose on Day 2|PK population. Number of participants analyzed = participants who were evaluable for this outcome.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
810593|NCT01053429|Other Pre-specified|Change From Baseline in Brief Psychiatric Rating Scale (BPRS ) - Improvement|BPRS-A: 18-item clinician rated scale to assess somatic concern, anxiety, emotional withdrawal, disorganization, hallucinatory behavior, guilt feelings, suspiciousness, disorientation, tension, mannerisms, posturing, grandiosity, depressive mood, hostility, motor retardation, uncooperativeness, unusual thought content, blunted affect, and excitement. Ratings anchored to improve consistency for a single rater over time or between raters. Items rated on 7-point scale 0 (not present) to 6 (extremely severe). Total score=sum of items (range 0 to 108); higher scores indicate increased pathology.|Baseline up to Week 8|Safety analysis set: all participants who received at least 1 dose of study treatment. It was recommended to use the optional BPRS tool to gather additional information for the improvement score under usual practice. The optional BPRS tool was not used during the study.||particpants|||Number
810594|NCT01053429|Primary|Number of Participants for Change From Baseline in Clinical Global Impression - Improvement (CGI-I) at Final Visit (up to Week 8) - PP|CGI-I is a single-item clinician rated scale used to assess the participant's improvement or worsening from baseline. Scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse); higher score indicates more affected.|Baseline up to Week 8|PP; N=number of participants with evaluable data at observation. Efficacy analysis planned for CGI-I at each visit but completed at last visit (no set schedule for study visits).||participants|||Number
810595|NCT01053429|Primary|Number of Participants for Change From Baseline in Clinical Global Impression - Improvement (CGI-I) at Final Visit (up to Week 8) - ITT|CGI-I is a single-item clinician rated scale used to assess the participant's improvement or worsening from baseline. Scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse); higher score indicates more affected.|Baseline up to Week 8|ITT; N=number of participants with evaluable data at observation. Efficacy analysis planned for CGI-I at each visit but completed at last visit (no set schedule for study visits).||participants|||Number
810596|NCT01053429|Primary|Number of Participants for Clinical Global Impression of Severity (CGI-S) Status at Final Visit (up to Week 8) - Per Protocol Population|CGI-S is a single-item clinician rated scale to rate the severity of a participant's illness over time. Scores range from 1 (normal, not ill at all) to 7 (among the most extremely ill); higher score indicates more affected.|Baseline up to Week 8|Per Protocol population (PP): participants in ITT group with study treatment for at least 8 (± 1 week) since enrollment and observed for final efficacy (inpatient visit or phone call). N=participants with evaluable data at observation. Efficacy analysis planned for CGI-S at each visit but completed at last visit (no set schedule for study visits).||participants|||Number
810597|NCT01053429|Primary|Number of Participants for Clinical Global Impression of Severity (CGI-S) Status at Final Visit (up to Week 8) - Intent to Treat Population|CGI-S is a single-item clinician rated scale to rate the severity of a participant's illness over time. Scores range from 1 (normal, not ill at all) to 7 (among the most extremely ill); higher score indicates more affected.|Baseline up to Week 8|Intent to treat population (ITT): administered at least 1 dose of study treatment at least once a week and observed for at least 1 efficacy assessment. N=number of participants with evaluable data at observation. Efficacy analysis planned for CGI-S at each visit but completed at last visit (no set schedule for study visits).||particpants|||Number
810598|NCT01053507|Secondary|Migraine Specific Quality of Life Questionnaire (MSQ)||Day 0, Day +30|No data displayed because outcome measure has zero total participants analyzed. No analysis was conducted. Study terminated due to low enrollment.|||||
810599|NCT01053507|Secondary|Headache Impact Test-6 (HIT-6) Score||Day 0, Day +30|No data displayed because outcome measure has zero total participants analyzed. No analysis was conducted. Study terminated due to low enrollment.|||||
810600|NCT01053507|Secondary|Mental Efficiency Workload Test (MEWT) Performance Index||Day 0, Day +30|No data displayed because outcome measure has zero total participants analyzed. No analysis was conducted. Study terminated due to low enrollment.|||||
810601|NCT01053507|Primary|Associated Headache Symptoms|Change in number of associated headache symptoms at Day 0 vs. Day +30 in Treximet arm vs. Placebo arm.|Day 0, Day +30|No data displayed because outcome measure has zero total participants analyzed. No analysis was conducted. Study terminated due to low enrollment.|||||
810602|NCT01053507|Primary|Headache Days|Change in number of headache days at Day 0 vs. Day +30 in Treximet arm vs. Placebo arm.|Day 0, Day +30|No data displayed because outcome measure has zero total participants analyzed. No analysis was conducted. Study terminated due to low enrollment.|||||
810603|NCT01053663|Secondary|Number of Participants With Oseltamivir Resistance Mutation|Resistance was assessed by neuraminidase (NA) and hemagglutinin (HA) genes sequencing analysis, using Reverse Transcription Polymerase Chain Reaction (RT-PCR).|Up to Day 30|Safety population.||participants|||Number
810604|NCT01053663|Secondary|Number of Participants With Greater Than or Equal to (≥) 5−Fold Change in Neuraminidase Inhibition (NAI) Assay 50 Percent (%) Inhibitory Concentration (IC50) Values|IC50 was defined as the concentration that causes 50% inhibition of viral activity. IC50 values were calculated using NAI assay. The 5-fold change was calculated as either ≥5 times change in the NAI IC50 visit value from the Reference value at a visit or ≥5 times change in the NAI IC50 Visit value from the Baseline value.|Baseline, Days 1, 3, 4, 6, 15|Safety population included all participants who received at least one dose of IV study medication and had a safety assessment performed after initiation of treatment. Here, number of participants analyzed = participants evaluable for this outcome measure, and n = participants evaluable for specified time-point, for each arm, respectively.||participants|||Number
810605|NCT01053663|Secondary|Time of the Last Measurable Plasma Concentration (Tlast) of Oseltamivir and Oseltamivir Carboxylate||Pre-dose (Hour 0), 2, 3-4, 5-7, and 10-12 hours post-dose on Day 1 and Day 2, pre-dose (Hour 0), 2 and 4 hours post-dose on Day 4|PK population. Number of participants analyzed = participants who were evaluable for this outcome, n = number of participants evaluable for specified categories.||hours||Geometric Coefficient of Variation|Geometric Mean
810606|NCT01053663|Secondary|Last Measurable Plasma Concentration (Clast) of Oseltamivir and Oseltamivir Carboxylate||Pre-dose (Hour 0), 2, 3-4, 5-7, and 10-12 hours post-dose on Day 1 and Day 2, pre-dose (Hour 0), 2 and 4 hours post-dose on Day 4|PK population. Number of participants analyzed = participants who were evaluable for this outcome, n = number of participants evaluable for specified categories.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
825468|NCT01191190|Secondary|Safety and Tolerability Measured Via Adverse Events|Please see Adverse Event module for additional details.|2 years|Total number of participants who had at least 1 adverse event||participants|||Number
810610|NCT01053663|Primary|Maximum Observed Plasma Concentration (Cmax) of Oseltamivir and Oseltamivir Carboxylate on Day 1||Pre-dose (Hour 0), 2, 3-4, 5-7, and 10-12 hours post-dose on Day 1|PK population. Number of participants analyzed = participants who were evaluable for this outcome.||nanogram/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
810611|NCT01053663|Primary|AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 4||Pre-dose (Hour 0), 2 and 4 hours post-dose on Day 4|PK population. Number of participants analyzed = participants who were evaluable for this outcome.||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
810612|NCT01053663|Primary|AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 2||Pre-dose (Hour 0), 2, 3-4, 5-7, and 10-12 hours post-dose on Day 2|PK population. Number of participants analyzed = participants who were evaluable for this outcome.||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
810613|NCT01053663|Primary|Area Under the Concentration Versus Time Curve From Time Zero to Last Measurable Plasma Concentration (AUClast) of Oseltamivir and Oseltamivir Carboxylate on Day 1||Pre-dose (Hour 0), 2, 3-4, 5-7, and 10-12 hours post-dose on Day 1|Pharmacokinetic (PK) population included all treated participants who had at least one blood sample evaluable for drug concentration level. Number of participants analyzed = participants who were evaluable for this outcome.||hour*nanogram/milliliter (h*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
810614|NCT01053741|Primary|Epithelial Disruption Graded by a Pathologist Blinded to Study Intervention.|"Endoscopy will be performed to obtain biopsy specimens at baseline and following each inpatient enema exposure. Samples will be obtained at each flexible sigmoidoscopy and set aside for batch sectioning and H&E staining. Slides will be reviewed and scored by a qualified pathologist blinded to treatment assignment using a qualitative scoring system. This scoring system uses semi-quantitative scoring that focuses on acute toxicity to epithelial cell layer similar to that seen in animal studies. This is a categorical grading scale, where 0 = Epithelial surface intact;1 = <1/3 of surface denuded; 2 = 1/3 - 2/3rds of surface denuded;3 = More than 2/3rds of surface denuded.
Six separate biopsies for each subject and each treatment intervention were analyzed in a multi-level analysis. In comparison with the baseline condition (no intervention), the odds and 95% confidence interval (CI) of having a higher epithelial denudation score were calculated for each intervention."|One hour|||units on a scale||Inter-Quartile Range|Median
810615|NCT01053819|Secondary|A Secondary Objective Will be to Evaluate the Identified Pigmented Lesions for Suspicious Criteria||Patients will complete the study within 6 months||||||
810616|NCT01053819|Primary|The Primary Endpoint for This Study Will be a Change From Baseline in the Number of Pigmented Lesions on Skin Previously Covered by Psoriatic Plaques.||Patients will complete study within 6 months.|||participants|||Number
810617|NCT01053897|Secondary|Manchester Scar Scale (MSS)|"Rating by investigator to assess various factors of scar appearance/characteristics on numeric scales.
MSS includes a visual analog scale (10 cm; 0 excellent appearance, 10 poor appearance) and four descriptive characteristics rated 1 to 4 according to the following descriptions.
Color: Perfect (1), Slight mismatch (2), Obvious mismatch (3), Gross mismatch (4).
Contour: Flush with surrounding skin (1), Slightly proud/indented (2), Hypertrophic (3), Keloid (4).
Distortion: None (1), Mild (2), Moderate (3), Severe (4). Texture: Normal (1), Just palpable (2), Firm (3), Hard (4).
Outcomes measured at 0.5, 1, 2, 3, 6, 9 and 12 Months. Reported Data is end of study (12 months)"|12 Month (End of Study)|||units on a scale||Standard Deviation|Mean
810618|NCT01053897|Secondary|Patient Observer Scar Assessment Scale (POSAS)|"Rating by subject and investigator (observer) to assess various factors of scar segment appearance/characteristics on a numeric scale (0-10). Individual parameters rated by the subject or observer according to a 0-10 scale where 0 equals no symptoms or difference from normal (better) and 10 equals the worst possible symptoms or difference from normal (worse).
Outcomes measured at 0.5, 1, 2, 3, 6, 9 and 12 Months. Reported Data is end of study (12 months)"|12 Month (End of Study)|All subjects were included||units on a scale||Standard Deviation|Mean
810619|NCT01053897|Secondary|Overall Scar Preference|Overall preference of the healing/appearance of each scar segment as completed by investigator and subject.|12 Month (End of Study)|All Subjects included.||participants|||Number
810620|NCT01053897|Primary|Photography- Independent Scar Assessment Panel|An independent panel was planned to review scar photography to determine more preferable outcomes. Panel was not performed.|0.5, 1, 2, 3, 6, 9 and 12 Months|All subjects had scar photography completed at study visits. However, due to the early termination of this trial, the independent panel review was not completed.|||||
810621|NCT01053988|Secondary|Time to Onset (Increase of 100 Milliliter [mL] From Baseline in 0-4 Hours Post-dose FEV1) on Treatment Day 1|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. Baseline FEV1 is defined as the mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1. Time to onset on Treatment Day 1 is defined as a 100 mL increase from Baseline in FEV1. Time to increase of 100 mL from Baseline was calculated over the 5, 15, 30 minutes, and 1, 2, and 4 hours time points. A participant who had at least one post-dose FEV1 on Day 1, but did not achieve a 100 mL or more increase from Baseline at any scheduled time-point at which FEV1 was assessed up to and including 4 hours was censored.|Baseline and Day 1|Intent-to-Treat (ITT) Population: all randomized participants who received at least one dose of study medication. Only those participants available at the indicated time point were assessed.||Minutes||Full Range|Median
810622|NCT01053988|Secondary|Change From Baseline in Peak Post-dose FEV1 (0-4 Hour) on Day 1|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. BL FEV1 is defined as the mean of the assessments made 30 minutes pre-dose and immediately pre-dose on Day 1. If one of these two assessments was missing then BL was defined as the single pre-dose FEV1 value on Day 1. Peak post-dose FEV1 (0-4 hours) is the maximum post-dose FEV1 recorded over the nominal timepoints of 5, 15 and 30 min, 1, 2 and 4 hours post the Day 1 dose. Change from BL is calculated as the peak post-dose FEV1 (0-4 hour) on Day 1 minus BL FEV1. Analysis performed used an Analysis of Covariance (ANCOVA) model with covariates of treatment, smoking status at screening (stratum), BL - mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1, and centre grouping.|Baseline and Day 1|Intent-to-Treat (ITT) Population: all randomized participants who received at least one dose of study medication. Only those participants available at the indicated time point and without missing covariate information were analyzed.||Liters||Standard Error|Least Squares Mean
825469|NCT01191190|Secondary|Treatment-Free Survival||2 years|||months||Full Range|Median
810623|NCT01053988|Secondary|Change From Baseline in Chronic Respiratory Disease Questionnaire Self-administered Standardized (CRQ-SAS) Dyspnea Score at Day 168|Considered an ‘Other’ endpoint by FDA. CRQ-SAS measures 4 domains (mastery, fatigue, emotional function, and dyspnea) of functioning of participants with COPD: mastery (amount of control the participant feels he/she has over COPD symptoms); fatigue (how tired the participant feels); emotional function (how anxious/depressed the participant feels); and dyspnea (how short of breath the participant feels during physical activities). Each domain is measured on a scale of 1-7 (1=maximum impairment; 7=no impairment). Each domain score is calculated separately. Current assessment was done only for dyspnea domain. BL scores are the derived scores for each domain and total at Day 1 pre-dose. Change from BL was calculated as the average at each visit minus the BL value. Analysis performed used a repeated measures model with covariates of treatment, smoking status at screening (stratum), BL (derived scores at Day 1 pre-dose), centre grouping, Day, Day by BL and Day by treatment interactions.|Baseline to Day 168|Intent-to-Treat (ITT) Population: all randomized par. who received at least one dose of study medication. Number of par. presented represent those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis||Scores on a scale||Standard Error|Least Squares Mean
810624|NCT01053988|Primary|Change From Baseline in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) FEV1 at Day 169|Co-Primary Endpoint: Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. Trough FEV1 measurements were taken electronically by spirometry on Days 2, 7, 14, 28, 56, 84, 112, 140, 168, and 169. BL was defined as the mean of the assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1.Trough FEV1 was defined as the mean of the FEV1 values obtained 23 and 24 hours after previous morning's dosing. Change from BL was calculated as the average at each visit minus the BL value. Analysis was performed using a repeated measures model with covariates of treatment, smoking status at screening (stratum), BL - mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1, centre grouping, Day, Day by BL and Day by treatment interactions.|Baseline to Day 169|Intent-to-Treat (ITT) Population: all randomized par. who received at least one dose of study medication. Number of par. presented represent those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis||Liters||Standard Error|Least Squares Mean
810625|NCT01053988|Primary|Change From Baseline in Weighted Mean FEV1 Over 0-4 Hours Post-dose at Day 168|Co-Primary Endpoint: Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. Serial FEV1 measurements were taken electronically by spirometry at BL, weeks 2, 8, 12, and 84 (Day 168). Weighted mean (WM) was calculated using the 0 - 4 h post-dose FEV1 measurements that included the pre-dose (Day 1: 30 minutes [min] and 5 min prior to dosing; other serial visits:23 and 24 h after previous morning dose) and post-dose (5, 15, and 30 min and 1, 2, and 4 h) assessments. BL FEV1 is the mean of the two assessments made 30 and 5 min pre-dose at Day 1. WM change from BL was the WM at the visit minus the BL value. Analysis was performed using a repeated measures model with covariates of treatment, smoking status at screening (stratum), BL- mean of the two assessments made 30 and 5 min pre-dose on Day 1, centre grouping, Day, Day by BL and Day by treatment interactions.|Baseline (BL) to Day 168|Intent-to-Treat (ITT) Population: all randomized par. who received at least one dose of study medication. Number of par. presented represent those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis||Liters||Standard Error|Least Squares Mean
810626|NCT01054079|Primary|Rate of Rise of Serum PSA|The difference of post treatment and pre-enrollment PSA.For those with multiple PSA measures post we use the median of those measures to estimate the participant’s post PSA level.|24 weeks|||Nanograms Per Milliliter||Inter-Quartile Range|Median
810627|NCT01054170|Secondary|Exacerbations|Number of patients experiencing disease exacerbations on treatment.|Exacerbations were recorded at all study visits (after 1, 4, 8, and 12 weeks of treatment and at follow up)|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||Participants|||Number
810628|NCT01054170|Secondary|Percentage of Reliever Free Days in Last Six Weeks of Treatment|Percentage of reliever free days in last 6 weeks on treatment.|Average from measurements recorded daily by patient in last 6 weeks of treatment.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||percentage of days||Standard Error|Least Squares Mean
810629|NCT01054170|Secondary|St George's Respiratory Questionnaire for COPD Patients (SGRQ-C) Overall Score|St George's Respiratory Questionnaire for Chronic Obstructive Pulmonary Disease, as a measure of Quality of Life (reported on a % scale from 0 (best health status) to 100(worst possible status)).|Measured after 12 weeks treatment (day 84)|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||Scores on a scale||Standard Error|Least Squares Mean
810630|NCT01054170|Secondary|EXAcerbations of Chronic Pulmonary Disease Tool (EXACT) Total Score|EXAcerbations of Chronic pulmonary disease Tool, patient questionnaire as a measure of respiratory symptoms (reported as units on a 0 (best health status) to 100 (worst possible status) scale).|Average from measurements recorded daily by patient in last 6 weeks of treatment.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||Total Score||Standard Error|Least Squares Mean
825470|NCT01191190|Secondary|Progression-free Survival (PFS)||2 years|||months||Full Range|Median
810631|NCT01054170|Secondary|Breathlessness, Cough and Sputum Scale (BCSS) Total Score|Breathlessness, Cough and Sputum Scale, patient reported questionnaire as a measure of respiratory symptoms (reported on a 0 (best health status) to 12 (worst possible status) scale).|Average from measurements recorded daily by patient in last 6 weeks of treatment.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||Total Score||Standard Error|Least Squares Mean
810632|NCT01054170|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Evening (Daily Recordings)|Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured at home by the patient each evening.|Average from measurements recorded daily by patient in last 6 weeks of treatment.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Error|Least Squares Mean
810633|NCT01054170|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Morning (Daily Recordings)|Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured at home by the patient each morning.|Average from measurements recorded daily by patient in last 6 weeks of treatment.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Error|Least Squares Mean
810634|NCT01054170|Secondary|Peak Expiratory Flow (PEF) Evening (Daily Recordings)|Peak Expiratory Flow (L/min) as a measure of lung function, measured at home by the patient each evening .|Average from measurements recorded daily by patient in last 6 weeks of treatment.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L/min||Standard Error|Least Squares Mean
810635|NCT01054170|Secondary|Peak Expiratory Flow (PEF) Morning (Daily Recordings)|Peak Expiratory Flow (L/min) as a measure of lung function, measured at home by the patient each morning.|Average from measurements recorded daily by patient in last 6 weeks of treatment.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L/min||Standard Error|Least Squares Mean
810636|NCT01054170|Secondary|Post-bronchodilator Slow Vital Capacity (SVC)|Slow Vital capacity (L) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic. End of treatment value or Last Observation Carried Forward (LOCF).|Measured after 12 weeks treatment (day 84)|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Error|Least Squares Mean
810637|NCT01054170|Secondary|Pre-bronchodilator Slow Vital Capacity (SVC)|Slow Vital Capacity (L) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic. End of treatment value or Last Observation Carried Forward (LOCF).|Measured after 12 weeks treatment (day 84)|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Error|Least Squares Mean
810638|NCT01054170|Secondary|Post-bronchodilator Forced Vital Capacity (FVC)|Forced Vital Capacity (L) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic. End of treatment value or Last Observation Carried Forward (LOCF).|Measured after 12 weeks treatment (day 84)|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Error|Least Squares Mean
810639|NCT01054170|Secondary|Pre-bronchodilator Forced Vital Capacity (FVC)|Forced Vital Capacity (L) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic. End of treatment value or Last Observation Carried Forward (LOCF).|Measured after 12 weeks treatment (day 84)|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Error|Least Squares Mean
810640|NCT01054170|Secondary|Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)|Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic. End of treatment value or Last Observation Carried Forward (LOCF).|Measured after 12 weeks treatment (day 84)|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Error|Least Squares Mean
810641|NCT01054170|Secondary|Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)|Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic. End of treatment value or Last Observation Carried Forward (LOCF).|Measured after 12 weeks treatment (day 84)|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Error|Least Squares Mean
810642|NCT01054170|Secondary|Pre-bronchodilator Diffusion Capacity of Carbon Monoxide (DLco)|Capacity of Carbon Monoxide as a measure of lung function. End of treatment Least Squares Mean.|Measured after 12 weeks treatment (day 84)|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||mmol/kPa*min||Standard Error|Least Squares Mean
810643|NCT01054170|Secondary|Pre-bronchodilator Specific Airway Conductance (SGaw)|Specific Airway Conductance as a measure of lung function. End of treatment Least Squares Mean.|Measured after 12 weeks treatment (day 84)|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||1/[s*kPa]||Standard Error|Least Squares Mean
810644|NCT01054170|Secondary|Pre-bronchodilator Residual Volume (RV)|Residual volume (L) as a measure of lung function. End of treatment Least Squares Mean.|Measured after 12 weeks treatment (day 84)|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Error|Least Squares Mean
810645|NCT01054170|Secondary|Pre-bronchodilator Functional Residual Capacity (FRC)|Functional Residual Capacity (L) as a measure of lung function. End of treatment Least Squares Mean.|Measured after 12 weeks treatment (day 84)|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Error|Least Squares Mean
810646|NCT01054170|Secondary|Pre-bronchodilator Total Lung Capacity (TLC)|Total Lung Capacity (L) as a measure of lung function. End of treatment Least Squares Mean.|Measured after 12 weeks treatment (day 84)|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Error|Least Squares Mean
810647|NCT01054170|Secondary|Pre-bronchodilator Inspiratory Capacity (IC)|Inspiratory Capacity (L) as a measure of lung function. End of treatment Least Squares Mean.|Measured after 12 weeks treatment (day 84)|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Error|Least Squares Mean
810648|NCT01054170|Secondary|Air Trapping Index (ATI) on Expiratory Scans|ATI Percentage as a measure of structural changes in airways. End of treatment Least Squares Mean.|Measured after 12 weeks treatment (day 84)|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||ATI Percentage||Standard Error|Least Squares Mean
810649|NCT01054170|Secondary|5th Generation Wall Area Percentage|5th Generation Wall Area Percentage as a measure of structural changes in airways. End of treatment Least Squares Mean.|Measured after 12 weeks treatment (day 84)|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||Percentage Area||Standard Error|Least Squares Mean
810650|NCT01054170|Primary|AWT-Pi10 (Airway Wall Thickness of a Theoretical Airway With an Internal Perimeter of 10 mm)|AWT-Pi10 (mm) as a measure of structural changes in airways. End of treatment Least Squares Mean.|Measured after 12 weeks treatment (day 84)|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||mm||Standard Error|Least Squares Mean
810651|NCT01054183|Primary|Overall Successful Intubation Rate: GlideScope Video Laryngoscopy (GVL) vs. Direct Laryngoscopy (DL).|Overall successful intubation rate defined as all successful intubations (by type) divided by all attempts (by type).|30 days; no long-term outcome measures were included|The study was powered for 62 patients per study arm. Due to slow patient enrollment, the study was stopped prior to full enrollment with the aforementioned 22 total patients.||Percent of successful intubations|Participants||Number
810652|NCT01054183|Primary|Percent of Participants With Successful 1st Intubation Attempt|Percent of participants with successful 1st intubation attempt by group (GVL vs. DL)|30 days|||Percent of Participants|||Number
810653|NCT01054222|Secondary|King’s Health Questionnaire (KHQ) Domain Scores|KHQ: self-administered questionnaire contained 21 questions scored in 9 domains (general health perception, incontinence impact, role limitations, physical limitations, social limitations, personal relationships, emotions, sleep/energy, and severity of urinary symptoms). Each domain score ranged: 0-100, where 0=best outcome/response and 100=worst outcome/response.|Baseline, End of Treatment (EOT) (Week 82)|Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points.||units on a scale||Standard Deviation|Mean
810661|NCT01054222|Secondary|Percentage of Incontinent Participants at Baseline|UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline|Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary.||Percentage of Participants|||Number
810654|NCT01054222|Secondary|Number of Participants With Response to Overactive Bladder Satisfaction Questionnaire (OAB-s) (Questions 5, 9, 10a-10d, and 11a-11b)|OAB-s assessed OAB medication expectations, daily life with OAB, and satisfaction with OAB medication. Question (Q) 5 evaluates OAB medication expectations (exceeds/meets or does not meet expectation). Q9 to 11 assessed satisfaction with OAB medication’s ability to allow reaching bathroom without urine loss (Q9), decrease: sudden urgencies to urinate (Q10a), urine loss due to urgency (Q10b), waking up at night to urinate (Q10c) and urination during day (Q10d), and improve control of urine loss (Q11a) and need to urinate (Q11b). Q9 to 11 were answered as ‘very satisfied’, ‘somewhat satisfied’, ‘neither dissatisfied nor satisfied’, ‘somewhat dissatisfied’, and ‘very dissatisfied’. The results for Q9 to 11 are reported as “satisfied” (participants who answered ‘very satisfied’ or ‘somewhat satisfied’ for all 7 questions) or “not satisfied” (participants who answered ‘neither dissatisfied nor satisfied’ or ‘somewhat dissatisfied’ or ‘very dissatisfied’ for all 7 questions).|Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (EOT) (Week 82)|Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points. Missing values were imputed using last observation carried forward (LOCF).||participants|||Number
810655|NCT01054222|Secondary|Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q)|OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.|Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)|Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points. Missing values were imputed using last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
810656|NCT01054222|Secondary|Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score|OAB-q: a self-administered, 33-item, questionnaire that assesses how much the participant has been bothered by selected bladder symptoms. Each item rated by participant on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score – lowest possible value of raw score)/range]*100. Higher scores values indicative of greater symptom bother.|Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)|Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points. Missing values were imputed using last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
810657|NCT01054222|Secondary|Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Months 3,6,9,12,15,18, and End of Treatment|PPUS: self-administered, single-item, questionnaire that measured the participant’s perception of urinary urgency. It was sensitive to changes in perceptions of urinary urgency over time. Score of 0 (usually not able to hold urine), 1 (usually able to hold urine [without leaking] until reaching toilet if go to toilet immediately), or 2 (usually able to finish what he/she was doing before going to toilet [without leaking]). Change = observation minus baseline. Deterioration: negative difference of scores; improvement: increase of 1 or more points in difference of scores, relative to baseline.|Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)|Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points. Missing values were imputed using last observation carried forward (LOCF).||Participants|||Number
810658|NCT01054222|Secondary|Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Month 3,6,9,12,15,18, and End of Treatment|PPBC: self-administered, single-item, questionnaire that asked participants to describe their perception of their bladder-related problems. PPBC assessment rated on a 6-point scale: 1=no problems at all, 2=some very minor problems, 3=some minor problems, 4=moderate problems, 5=severe problems, 6=many severe problems. Change = observation minus baseline. Results categorized as Deterioration (score difference ≥1), No Change (score difference=0), Improvement (score difference less than [<]0).|Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)|Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points. Missing values were imputed using last observation carried forward (LOCF).||Participants|||Number
810659|NCT01054222|Secondary|Mean Number of Urinary Incontinence Pads, Barrier Creams and Powder Used Per 24 Hours|The mean number of urinary incontinence pads (IP), barrier creams (BC) and powder used per 24 hours is calculated as the total number of IP, BC and powder used divided by the total number of diary days collected at that visit.|Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)|FAS: all enrolled participants who had taken at least one dose of study treatment during study and completed at least one micturition diary. N (number of participants analyzed) signifies participants who had baseline UUI episodes >0 per 24 hours. 'n' signifies participants evaluable for this measure at specified time points. LOCF was used.||Units per 24 hours||Standard Deviation|Mean
810660|NCT01054222|Secondary|Percentage of Participants With No Urgency Urinary Incontinence (UUI) Episode|UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)|FAS: all enrolled participants who had taken at least one dose of study treatment during study and completed at least one micturition diary. N (number of participants analyzed) signifies participants who had baseline UUI episodes >0 per 24 hours. 'n' signifies participants evaluable for this measure at specified time points. LOCF was used.||Percentage of Participants|||Number
810662|NCT01054222|Secondary|Daily Sum Rating on the Urinary Sensation Scale (USS)|The daily sum rating was calculated as the mean rating score on the USS multiplied by the mean number of micturitions per 24 hours at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. Numerical decrease indicates improvement.|Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)|Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points. Missing values were imputed using last observation carried forward (LOCF).||Units on a Scale||Standard Deviation|Mean
810663|NCT01054222|Secondary|Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours|UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)|Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points. Missing values were imputed using last observation carried forward (LOCF).||episodes per 24 hours||Standard Deviation|Mean
810664|NCT01054222|Secondary|Mean Number of Nocturnal Micturitions Per 24 Hours|Nocturnal micturitions were defined as micturitions with USS rating 1-5 that occurred between the time the participant went to bed and the time he or she arose to start the next day. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The mean number of nocturnal micturitions per 24 hours was calculated as the total number of nocturnal micturitions divided by the total number of diary days collected at that visit.|Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)|Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points. Missing values were imputed using last observation carried forward (LOCF).||micturitions per 24 hours||Standard Deviation|Mean
810665|NCT01054222|Secondary|Mean Number of Micturitions Per 24 Hours|Micturitions include episodes of voluntary micturition and episodes of Urgency Urinary Incontinence (UUI). UUI episodes were defined as those micturitions with USS rating of 5 in the diary in participants with UUI at baseline. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)|Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points. Missing values were imputed using last observation carried forward (LOCF).||micturitions per 24 hours||Standard Deviation|Mean
810666|NCT01054222|Secondary|Mean Number of Severe Micturition-Related Urgency Episodes Per 24 Hours|The mean number of severe micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to (>=) 4 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)|Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points. Missing values were imputed using last observation carried forward (LOCF).||episodes per 24 hours||Standard Deviation|Mean
810667|NCT01054222|Secondary|Mean Number of Micturition-Related Urgency Episodes Per 24 Hours|The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Month 3, 6, 9, 12, 15, 18|Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points. Missing values were imputed using last observation carried forward (LOCF).||episodes per 24 hours||Standard Deviation|Mean
810668|NCT01054222|Primary|Mean Number of Micturition-Related Urgency Episodes Per 24 Hours (End of Treatment [EOT])|The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with Urinary Sensation Scale (USS) rating of greater than or equal to (>=) 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|End of Treatment (up to Week 82)|Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. Missing values were imputed using last observation carried forward (LOCF).||episodes per 24 hours||Standard Deviation|Mean
810669|NCT01054339|Secondary|Changes in Serum Total Alpha-1 Antitrypsin Concentrations|The change in serum total alpha-1 antitrypsin concentration was calculated as the difference between the mean values at the screening and baseline visits and the mean values at the 6, 9 and 12 month visits. The standard error of the difference was calculated as sqrt(s1^2/n1 + s2^2/n2, where s1 is the standard deviation of the baseline mean, s2 is the standard deviation of the month 6-12 mean, n1 is the number of baseline values and n2 is the number of month 6-12 values.|During months 6-12 after study agent adminstration|Analysis bsed on all subjects enrolled in study.||micromolar||Standard Error|Mean
810686|NCT01054573|Secondary|Percentage of Participants Achieving Extended Rapid Virologic Response (eRVR)|The table below shows the percentage of participants who had a Extended Rapid Virologic Response (eRVR) (ie, those with undetectable hepatitis C virus [HCV] ribonucleic acid [RNA values of <25 IU/mL, target not detected at at Weeks 4 and 12 of treatment).|Weeks 4 and 12|All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study drug.||Percentage of participants|||Number
810670|NCT01054339|Secondary|Changes in Serum M-specific Alpha-1 Antitrypsin Concentration|The change in serum M-specific alpha-1 antitrypsin concentration was calculated as the difference between the mean values at the screening and baseline visits and the mean values at the 6, 9 and 12 month visits. The standard error of the difference was calculated as sqrt(s1^2/n1 + s2^2/n2, where s1 is the standard deviation of the baseline mean, s2 is the standard deviation of the month 6-12 mean, n1 is the number of baseline values and n2 is the number of month 6-12 values.|During months 6-12 after study agent adminsitration|One subject in low dose group had AAT phenotype SZ, which made measurement of M-specific serum alpha-1 antitrypsin concentration invalid.||nanomolar||Standard Error|Mean
810671|NCT01054339|Primary|Frequency of Grade 3 or 4 Adverse Events||During 1 year after study agent administration|Analysis based on all subjects enrolled in study.||participants|||Number
810672|NCT01054404|Primary|Acceptable vs. Unacceptable Brain Relaxation at Dural Opening|"Rating of brain relaxation will be on a 4-point scale:
0 = brain very relaxed under dura, acceptable
= brain adequately relaxed under dura, acceptable
= brain slightly tense under dura, acceptable
= brain very tense under bulging dura, unacceptable"|just prior to dural opening for each subject|||units on a scale 0-3||Standard Error|Mean
810673|NCT01054560|Primary|Procedure-related Serious Adverse Events (SAEs)|Incidence of study procedure-related Serious Adverse Events (SAEs)|90 Day|Intent-to-treat||percentage of subjects|||Number
810674|NCT01054560|Primary|Study Device-related Serious Adverse Events (SAEs)|Incidence of study device-related Serious Adverse Events (SAEs)|90 Day|Intent-to-treat||percentage of subjects|||Number
810675|NCT01054560|Secondary|Non-fatal Stroke-related Morbidity|Morbidity data is presented in terms of subjects with permanent deficit as a result of one or more adverse events|90 Day|Intent-to-treat||percentage of subjects|||Number
810676|NCT01054560|Secondary|Symptomatic Intracranial Hemorrhage|Symptomatic hemorrhage within 24 hours of procedure. Symptomatic hemorrhages is defined as any parenchymal hematoma 1 (PH1), parenchymal hematoma 2 (PH2), intraparenchymal hemorrhage remote from the ischemic field (RIH), intraventricular hemorrhage (IVH), and subarachnoid hemorrhage (SAH) associated with a worsening of National Institutes of Health Stroke Scale (NIHSS) ≥ 4 within 24hrs.|24 hours|Intent to treat||Percentage of subjects|||Number
810677|NCT01054560|Secondary|Mortality|Rate of Mortality|90 Days follow-up|Intent-to-treat||Percentage of subjects|||Number
810678|NCT01054560|Secondary|Good Neurological Outcome 90 Days|Good neurological outcome, defined as modified Rankin scale (mRS) ≤ 2, or equal to the prestroke mRS if the prestroke mRS was higher than 2, or National Institutes of Health Stroke Scale (NIHSS) score improvement of 10 points or more|90 Days Follow-up|Unavailability of data contributed to fewer subjects analyzed compared to the cohort sample size.||Percent of subjects|||Number
810679|NCT01054560|Secondary|Good Neurological Outcome at 30 Days|Good neurological outcome, defined as modified Rankin scale (mRS) ≤ 2, or equal to the prestroke mRS if the prestroke mRS was higher than 2, or National Institutes of Health Stroke Scale (NIHSS) score improvement of 10 points or more|30 Days Follow-up|Unavailability of data contributed to fewer subjects analyzed compared to the cohort sample size.||Percent of subjects|||Number
810680|NCT01054560|Secondary|Time to Initial Recanalization|Time from guide catheter placement to first visualization of Thrombolysis in Myocardial Infarction (TIMI) 2 flow|post treatment|Unavailability of data contributed to fewer subjects analyzed compared to the cohort sample size||minutes||Standard Deviation|Mean
810681|NCT01054560|Primary|Recanalization [Thrombolysis in Myocardial Infarction (TIMI) 2 or 3] Without Symptomatic Intracranial Hemorrhage|"Successful arterial recanalization of occluded target vessel measured by Thrombolysis in Myocardial Infarction (TIMI) score of 2 or 3 following the use of the SOLITAIRE™ or MERCI® Device without any symptomatic intracranial hemorrhage and rescue therapy within 3 passes.
Thrombolysis in Myocardial Infarction (TIMI) score describes the distal flow perfusion and revascularization before and following therapy.
TIMI 0 - No perfusion (worst outcome) TIMI 1 - Perfusion past the initial occlusion, but no distal branch filling TIMI 2 - Perfusion with incomplete or slow distal branch filling TIMI 3 - Full perfusion with filling of all distal branches (best outcome)"|Immediately post treatment|Data was unavailable for two subjects from the randomized Solitaire and one from the randomized Merci cohort. Thus, the Core Lab evaluated data from 56 in the Solitaire FR group and 54 in the Merci group.||Percent of Subjects|||Number
810682|NCT01054573|Secondary|Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level|The table below shows change from baseline in log 10 plasma HCV RNA values measured over time.|Baseline, Weeks 4, 8, 12, 24, 36, and 48|All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study drug.||log 10 IU/ml||Full Range|Median
810683|NCT01054573|Secondary|Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values Over Time|The table below shows plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) values measured over time.|Baseline, Weeks 4, 8, 12, 24, 36, 48|All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study drug.||Log 10 IU/mL||Full Range|Median
810684|NCT01054573|Secondary|Percentage of Participants Who Relapsed During Follow-Up|The table below shows the percentage of participants who relapsed (ie, those having confirmed detectable hepatitis C virus [HCV] ribonucleic acid [RNA] during the 24-week follow-up period after previous HCV RNA <25 IU/mL, target not detected, at end of treatment).|During Follow-Up (24 weeks after the last dose of study drug, administerd at 48 weeks)|The analysis was performed on the full analysis (FA) set, which included all randomized participants who received at least one dose of study drug and had data at the follow-up visit performed 24 weeks after the last dose of study drug.||Percentage of participants|||Number
810685|NCT01054573|Secondary|Percentage of Participants With Viral Breakthrough|The table below shows the percentage of participants with viral breakthrough defined as a confirmed increase >1 log10 in hepatitis C virus (HCV) ribonucleic acid (RNA) level from the lowest level reached during the considered treatment phase up to the considered time point, if the lowest level reached is > 25 IU/mL, or a confirmed value of HCV RNA >100 IU/mL in participants whose HCV RNA had previously become <25 IU/mL (detected or target not detected) during the considered treatment phase.|Week 48 (Period After Telaprevir Intake) and Week 12 (Telaprevir Treatment Phase)|All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study drug.||Percentage of participants|||Number
810707|NCT01048593|Primary|Anterior Chamber Cells = 0 at Day 8 Post Treatment||Day 8 post treatment||||||
810687|NCT01054573|Secondary|Percentage of Participants Achieving Rapid Virologic Response (RVR)|The table below shows the percentage of participants who had a rapid virologic response (RVR) (ie, those with undetectable hepatitis C virus [HCV] ribonucleic acid [RNA values of <25 IU/mL, target not detected at Week 4 of treatment).|Week 4|All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study drug.||Percentage of participants|||Number
810688|NCT01054573|Secondary|Percentage of Participants Who Met a Virologic Stopping Rule That Required Them to Permanently Discontinue All Study Drugs at Week 12, 24, or 36|The table below shows the percentage of participants at Week 12, 24, and 36 who met a stopping rule. The stopping rule at Week 12 was having hepatitis C virus (HCV) ribonucleic acid (RNA) value of >100 IU/mL and the stopping rule at Weeks 24 or 36 was having a HCV RNA value of >=25 IU/mL.|Week 12 or Weeks 24 or 36|All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study drug.||Percentage of participants|||Number
810689|NCT01054573|Secondary|Percentage of Participants Who Met a Virologic Stopping Rule That Required Them to Permanently Discontinue Telaprevir and Continue Pegylated Interferon (Peg-IFN) and Ribavirin (RBV) at Week 4 or Week 8|The table below shows the percentage of participants at Week 4 or 8 who met a stopping rule defined as having a hepatitis C virus (HCV) ribonucleic acid (RNA) value >100 IU/mL.|Week 4, Week 8|All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study drug.||Percentage of participants|||Number
810690|NCT01054573|Secondary|The Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected at Different Time Points|The table below shows the percentage of participants with undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) levels of less than 25 IU/ml, target not detected at different time points during the study. Data was imputed for participants with missing values using the last observation carried forward (LOCF) method for missing values.|Baseline, Weeks 4, 8, 12, 24, 36, and 48, and at the end of treatment (Week 48 or at time of early discontinuation)|All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study drug.||Percentage of participants with response|||Number
810691|NCT01054573|Primary|The Percentage of Participants Achieving a Sustained Virologic Response (SVR) 24 Weeks After the Last Dose of Study Drug (SVR24 Actual)|The table below shows the percentage of participants acheiving a SVR 24 weeks after the last dose of study drug defined as having plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels < 25 IU/mL, target not detected at end of treatment (EOT) AND the participant did not relapse AND the participant completed the treatment; OR if the participant had plasma HCV RNA levels of < 25 IU/mL, target not detected at EOT AND the participant did not relapse AND the participant prematurely discontinued at least one study medication, but never for the reason virologic failure.|End of trial (24 weeks after last dose, administerd at 48 weeks)|All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study drug.||Percentage of participants with response|||Number
810692|NCT01048424|Secondary|Change in Incontinence- or Bladder-specific Quality of Life|Incontinence Impact Questionnaire. Scores on the overall IIQ range from 0 to 400, with higher scores indicating greater overall impact on quality of life.|Baseline to 6 weeks|||Score on a Scale||Standard Deviation|Mean
810693|NCT01048424|Secondary|Change in Sleep Quality|The Pittsburgh Sleep Quality Index. A global sleep quality score derived from the PSQI can be used to index overall quality of sleep over the prior one-week period. Global sleep quality scores are continuous (range 0-21), with high scores reflecting poor sleep quality.|Baseline to 6 weeks|||Score on a Scale||Standard Deviation|Mean
810694|NCT01048424|Secondary|Change in Perceived Stress|Cohen Perceived Stress Scale. Scores are scaled from 0 to 40, with higher scores indicated greater perceived stress.|Baseline to 6 weeks|||Score on a Scale||Standard Deviation|Mean
810695|NCT01048424|Secondary|Change in Depression Symptoms|Beck Depression Inventory. Range of 0-63 (0-9 normal; 10-16 mild; 17-29 moderate; 30-63 severe).|Baseline to 6 weeks|||Score on a Scale||Standard Deviation|Mean
810696|NCT01048424|Secondary|Change in Anxiety Symptoms|Hospital Anxiety and Depression Scale. Anxiety Subscale range from 0 to 21, with scores of less than 8 indicative of absence of anxiety symptoms, 8 or above suggesting anxiety symptoms, and 12 or above suggesting generalized anxiety disorder.|Baseline to 6 weeks|||Score on a Scale||Standard Deviation|Mean
810697|NCT01048424|Secondary|Change in Overactive Bladder Symptoms|The Overactive Bladder Questionnaire (OAB-Q). 0- to 100-point scale. Higher scores on the OAB-Q indicate greater bothersomeness and impact of overactive bladder symptoms.|Baseline to 6 weeks|||Score on a Scale||Standard Deviation|Mean
810698|NCT01048424|Secondary|Percent Change in Daytime Voiding Frequency.|The number of incontinence episodes per week was calculated only over a 1-week period before the 6-week visit. There were no other interim outcomes assessment timepoints.|Baseline to 6 weeks|||Percent Change||Standard Deviation|Mean
810699|NCT01048424|Secondary|Percent Change in Any Urinary Incontinence Episodes Per Week|The number of incontinence episodes per week was calculated only over a 1-week period before the 6-week visit. There were no other interim outcomes assessment timepoints.|Baseline to 6 weeks|||Percent Change||Standard Deviation|Mean
810700|NCT01048424|Primary|Percent Change in Urgency Urinary Incontinence Episodes Per Week|The number of incontinence episodes per week was calculated only over a 1-week period before the 6-week visit. There were no other interim outcomes assessment timepoints.|baseline to 6 weeks|||Percent Change||Standard Deviation|Mean
810701|NCT01048502|Secondary|Changes in Inflammatory Parameter (Plasma TNF-α Levels) After Treatment With Fenofibrate or Placebo.||baseline and 6-8 weeks|||pg/mL||Standard Deviation|Median
810702|NCT01048502|Primary|The Effect of Omega-3 Fatty Acid Supplementation on Cytokine Production (Plasma Levels of TNFα) During an in Vivo Inflammatory Challenge (LPS).||randomization and 8 weeks post|||pg/mL||Inter-Quartile Range|Median
810703|NCT01048541|Secondary|Median Absolute RU Volume||3 catheterisations on 1 day||||||
810704|NCT01048541|Secondary|The Difference in Incidence of Adverse Events (AEs) and Adverse Device Events (ADEs)||Study period||||||
810705|NCT01048541|Primary|Mean Residual Urine Volume|Residual urine was mesured by ultrasound measurement of bladder content after intermittent catherisation|3 catheterisations on 1 day|||mL||Standard Deviation|Mean
810706|NCT01048593|Primary|Number of Participants With Clearing of Anterior Chamber Cells (ACC=0)||Day 8|||participants|||Number
810735|NCT01048658|Secondary|Patient and Provider Satisfaction With Anesthesia|Scores reported on 10-cm Visual Analog Scale (VAS anchors: 0= not satisfied at all, 10= completely satisfied) . Reported as mean +/- standard deviation. Subjects and providers were blinded to anesthesia method. Subjects and providers completed post-operative questionnaire within 30 minutes of procedure completion.|Post-procedure, within 30 minutes|||cm||Standard Deviation|Mean
810736|NCT01048658|Secondary|Number of Participants Experiencing Side Effects (Nausea, Dizziness)||Post-procedure, within 30 minutes|||Participants|||Count of Participants
810737|NCT01048658|Secondary|Procedure Time: T-test (Time of Speculum Placement to Time Speculum Removed)|Length of procedure from time of speculum placement to time of speculum removal, in minutes.|Time of speculum place to time of speculum removal, an average of 7.1 minutes|||minutes||Standard Deviation|Mean
810738|NCT01048658|Secondary|Number of Participants With Estimated Blood Loss Greater Than 300 mL (Yes/no)|Procedural blood loss greater than 300 mL. Blood loss was measured in a standardized fashion (amniotic fluid was discarded, blood was separated from tissue, and all gauze surgical drapes weighed).|At time of uterine evacuation, an average of 7.1 minutes|||Participants|||Count of Participants
810739|NCT01048658|Primary|Number of Participants Needing Intervention to Treat Blood Loss (a Composite of Use of Uterotonics, Re-aspiration, and Bimanual Massage)|Provider report for need to intervene due to blood loss (yes/no)|At time of uterine evacuation and immediately post-operatively, an average of 7.1 minutes|||Participants|||Count of Participants
810740|NCT01048671|Secondary|Number of Participants With at Least One Adverse Event|An adverse event was defined as any untoward, undesired, or unplanned clinical event in the form of physical signs, symptoms, disease, laboratory or physiological observations in a participant administered the sponsor’s product whether or not related to the use of the product.|Up to 25 months after start of raltegravir treatment|Participants enrolled and not excluded for a protocol violation were included in the analysis.||Participants|||Number
810741|NCT01048671|Primary|Mean Change From Baseline in CD4 Cell Count: Participants Still Receiving Raltegravir Treatment at Month 24||Baseline and 24 months after start of raltegravir treatment|All participants with a CD4 cell count available and receiving raltegravir treatment at 24 months were included in the analysis. A single treatment arm was specified in the study, but participants were sub grouped by their prior ARV experience at Baseline (ARV naïve, suppressed, or virological failure) for analysis.||cells/mm^3||95% Confidence Interval|Mean
810742|NCT01048671|Primary|Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count: All Treated Participants||Baseline and 24 months after start of raltegravir treatment|All participants with a CD4 cell count available at 24 months were included in the analysis. A single treatment arm was specified in the study, but participants were sub grouped by their prior ARV experience at Baseline (ARV naïve, suppressed, or virological failure) for analysis.||cells/mm^3||95% Confidence Interval|Mean
810743|NCT01048671|Primary|Percentage of Participants Responding to Treatment: Participants Still Receiving Raltegravir Treatment at Month 24|Response to treatment was defined as a viral load <50 RNA copies/mL|24 months after start of raltegravir treatment|All participants with a viral load assessment available and receiving raltegravir treatment at 24 months were included in the analysis. A single treatment arm was specified in the study, but participants were sub grouped by their prior ARV experience at Baseline (ARV naïve, suppressed, or virological failure) for analysis.||Percentage of participants||95% Confidence Interval|Number
810744|NCT01048671|Primary|Percentage of Participants Responding to Treatment: All Treated Participants|Response to treatment was defined as a viral load <50 RNA copies/mL|24 months after start of raltegravir treatment|All participants with a viral load assessment available at 24 months were included in the analysis. A single treatment arm was specified in the study, but participants were sub grouped by their prior ARV experience at Baseline (ARV naïve, suppressed, or virological failure) for analysis.||Percentage of participants||95% Confidence Interval|Number
810745|NCT01048671|Primary|Percentage of Participants Receiving Antiretroviral Treatments Administered With Raltegravir|Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting. ARV treatments included any nucleoside reverse transcriptase inhibitors (NRTIs), combination of tenovir/emitricitabine (FTC/TDF), combination of lamivudine/abacavir (3TC/ABC), protease inhibitors, and others.|Up to 25 months after start of raltegravir treatment|Two participants were excluded for protocol violation (inclusion criterion not met) and data were missing for 3 additional participants.||Percentage of participants|||Number
810746|NCT01054586|Other Pre-specified|Median Bilirubin Level at Baseline|Participant characteristics at baseline according to treatment group.|Baseline|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe||milligrams (mg)/deciliter (dl)||Full Range|Median
810747|NCT01054586|Other Pre-specified|Median Blood Platelet Count at Baseline|Participant characteristics at baseline according to treatment group.|Baseline|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe||10^9/liter||Full Range|Median
810748|NCT01054586|Secondary|Incidence Rates Per 100 Person-years of Follow-up (PYFU) of Study Main Outcome Measures|Incidence rates per 100 person-years of follow-up of study primary outcome. The numbers analyzed in the category titles represent the number of patients with each event. Incidence rate is the number of new cases per population in a given time period, where the denominator is the sum of the person-time of the at-risk population.|Incidence of these events was assessed over time during Year 1|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe||incidence rate|||Number
810749|NCT01054586|Secondary|Number of Participants for Which the Reason for Discontinuation of One or More Drugs in the FPV/RTV or LPV/RTV Regimen Was Due to Adverse Events Only|Number of participants for which the reason for discontinuation of one or more drugs in the FPV/RTV or LPV/RTV regimen was due to adverse events only. Adverse events can only be attributed to the body system stated (no further specificity is available)|The incidence of these events was assessed over time during Year 1|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe||participants|||Number
810750|NCT01054586|Secondary|Number of Participants With the Indicated Major Reasons for Discontinuing One or More Drugs in the FPV/r or LPV/r Regimen|Major reasons for discontinuing one or more drugs in the FPV/r or LPV/r regimen|Assessed over time during Year 1|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe||participants|||Number
810751|NCT01054586|Secondary|Number of Participants Who Discontinued the Indicated Antiretrovirals for the First Time After Starting FPV/r or LPV/r|Antiretrovirals discontinued for the first time after starting FPV/r or LPV/r|Assessed over time during Year 1|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe||participants|||Number
810752|NCT01054586|Secondary|Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone Due to the Indicated Adverse Events|Defined as the first occurrence of stopping FPV/RTV or LPV/RTV; where the reason for stopping is attributed to adverse events only. Adverse events can only be attributed to the body system stated (no further specificity is available).|Incidence was assessed over time during Year 1|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe||events|||Number
810753|NCT01054586|Secondary|Number of Events of Discontinuation of One or More Drugs in the FPV/RTV- or LPV/RTV Regimen Due to Adverse Events Only|Defined as the occurrence of stopping FPV/RTV or LPV/RTV; where the reason for stopping is attributed to adverse events only|Incidence was assessed over time during Year 1|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe||events|||Number
810754|NCT01054586|Secondary|Number of Events of First Discontinuation of One or More Drugs Included in the FPV/RTV- or LPV/RTV-based Regimen by Treatment Group, Controlling Current Values of CD4 and Platelet Counts|A first discontinuation is defined as the first occurrence of stopping one or more drugs in the FPV/RTV or LPV/RTV-based regime.|Incidence was assessed over time during Year 1|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe||events|||Number
810755|NCT01054586|Secondary|Number of Events of First Discontinuation of One or More Drugs Included in the FPV/RTV- or LPV/RTV-based Regimen by Treatment Group, Controlling for FIB-score and Other Variables|A first discontinuation is defined as the first occurrence of stopping one or more drugs in the FPV/RTV or LPV/RTV-based regime.|Incidence was assessed over time during Year 1|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe||events|||Number
810756|NCT01054586|Secondary|Number of Events of First Discontinuation of One or More Drugs Included in the FPV/RTV- or LPV/RTV-based Regimen by Treatment Group, Controlling for APRI-score and Other Variables (See Comments)|A first discontinuation is defined as the first occurrence of stopping one or more drugs in the FPV/RTV or LPV/RTV-based regime|Incidence was assessed over time during Year 1|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe||events|||Number
810757|NCT01054586|Secondary|Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone Due to Adverse Events Only|A first discontinuation is defined as the first occurrence of stopping FPV/RTV or LPV/RTV; where the reason for stopping is attritubed to adverse events only|Incidence was assessed over time during Year 1|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe||events|||Number
810758|NCT01054586|Other Pre-specified|Median ALT and AST Scores at Baseline|Participants characteristics at baseline according to treatment group.|Baseline|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe||IU/L (International Units per Liter)||Full Range|Median
810759|NCT01054586|Other Pre-specified|Median Model of End-stage Liver Disease (MELD) Score at Baseline|MELD is a scoring system for assessing the severity of chronic liver disease and is used to predict participant survival. It is calculated using biochemical values as follows: MELD = (0.957 x Log[Creatinine]) + (0.378 x Log[Bilirubin]) + (1.120 x Log[INR]) + 0.6431. INR = International Normalized Ratio for prothrombin time. MELD scores range between 0 and 40, with 40 being the most severe, i.e., 100% mortality. In interpreting the MELD score in hospitalized participants, the 3-month mortality is: score >=40, 100% mortality; 30–39, 83% mortality; 20–29, 76% mortality; 10–19, 27% mortality.|Baseline|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe. MELD scores are not available for the “FPV 700 mg BID/RTV 100 mg QD” group due to missing data.||MELD score||Full Range|Median
810760|NCT01054586|Other Pre-specified|Median FIB (a Model of End-stage Liver Disease) Score at Baseline|The FIB-4 score is an index that combines biochemical values (platelets, ALT, AST) and age to determine the degree of hepatic fibrosis. FIB-4 = (Age x AST)/(Platelet counts x ALT1/2). The FIB-4 score ranges between values of 0 to 13. A score of <1.45 indicates no/moderate fibrosis (F0-F1-F2-F3 in the ISHAK classification of fibrosis), whereas a score >3.25 is indicative of extensive fibrosis or cirrhosis (F4-F5-F6). The ISHAK classification of fibrosis is a commonly used scoring system that stages fibrosis from 0-6 (1-2, portal fibrotic expansion; 3-4, bridging fibrosis; 5-6, cirrhosis).|Baseline|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe||FIB Score||Full Range|Median
810761|NCT01054586|Other Pre-specified|Median Aspartate Aminotransferase (AST)-Platelet Ratio Index (APRI) Score at Baseline|The APRI score (AST to platelet ratio index) is an index comprised of biochemical values and is used to determine the degree of hepatic fibrosis. It is calculated as follows: APRI score = ([AST level/Upper Limit Normal]/Platelet counts) x 100. AST = Aspartate aminotransferase. In general, APRI scores range from 0 to >2.0, where scores <0.5 indicate no significant fibrosis, scores >1.5 indicate significant fibrosis, and scores >2.0 have been shown to be best correlated with the presence of cirrhosis.|Baseline|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe||APRI Score||Full Range|Median
810762|NCT01054586|Other Pre-specified|Cluster of Differentiation (CD4) Count at Baseline|Participant characteristics at baseline according to treatment group. CD4 count is a measurement of how many functional CD4 T-cells are circulating in the blood. The lower the absolute CD4 count, the weaker the immune system.|Baseline|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe||cells/microliter (μl)||Full Range|Median
810763|NCT01054586|Secondary|Number of Events of First Discontinuation of FPV/RTV- or LPV/RTV Alone by Treatment Group, Controlling for Current Values of CD4 and Platelet Counts|A first discontinuation is defined as the first occurrence of stopping FPV/RTV or LPV/RTV|Incidence was assessed over time during Year 1|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe||events|||Number
810764|NCT01054586|Other Pre-specified|Median Length of Participant Follow-up and Length of Time on Antiretroviral Therapy (ART) at Baseline|Participant characteristics at baseline are presented according to treatment group. ART is used for the treatment of HIV.|Baseline|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe||years||Full Range|Median
824509|NCT01175018|Secondary|Median Difference Between the 2 Arms in the Ratio of Minute Ventilation and Carbon Dioxide Production (VE/VCO2 Slope) at 10-14 Weeks||10-14 weeks|||(no units; ratio of values)||Inter-Quartile Range|Median
810765|NCT01054586|Secondary|Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone by Treatment Group, Controlling for FIB-score, and Other Variables|A first discontinuation is defined as the first occurrence of stopping FPV/RTV or LPV/RTV.|Incidence was assessed over time during Year 1|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe||events|||Number
810766|NCT01054586|Secondary|Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone by Treatment Group, Controlling for APRI-score, and Other Variables|A first discontinuation is defined as the first occurrence of stopping FPV/RTV or LPV/RTV.|Incidence was assessed over time during Year 1|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe||events|||Number
810767|NCT01054586|Primary|Number of Events of an Elevation in ALT After Baseline by Treatment Group, Controlling for Current Values of CD4 and Platelet Counts|An elevation in ALT is defined as a single value >200 IU/I.|Incidence was assessed over time during Year 1|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe||events|||Number
810768|NCT01054586|Primary|Number of Events of an Elevation in ALT After Baseline by Treatment Group, Controlling for FIB-score, and Other Variables|An elevation in ALT is defined as a single value >200 IU/I.|Incidence was assessed over time during Year 1|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe||events|||Number
810769|NCT01054586|Primary|Number of Events of an Elevation in ALT After Baseline by Treatment Group, Controlling for APRI-score, and Other Variables|An elevation in ALT is defined as a single value >200 IU/I.|Incidence of these events was assessed over time during Year 1, censoring patients' follow-up at date of last ALT|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe||events|||Number
810770|NCT01054586|Primary|Number of Events of ALT Elevation After Baseline, Controlling for APRI Score and Other Variables|An elevation in ALT is defined as a single value >200 IU/I.|The incidence of these events was assessed over time during Year 1, censoring participants' follow-up at date of last ALT|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe||events|||Number
810771|NCT01054599|Secondary|A Secondary Analysis Will Examine the Possible Sustained Benefit of Continued Memantine Use.|SRT-CLTR (range 0-72; higher scores indicate better memory), and 7-24 Spatial Memory Test (range 0-35; scores are summed across the 5 learning trials, with higher scores indicating better memory) scores will be assessed across the first (baseline) and third (post-open label memantine) testing sessions. These measures are considered to be scores on a scale, rather than standard units. The hypothesis was that subjects randomized to memantine would demonstrate sustained improvement from baseline, while the placebo group would demonstrate improvements after taking open label memantine (compared to baseline).|26 weeks|This analysis included only those subjects who participated in the open label extension period.||scores on a scale||Standard Deviation|Mean
810772|NCT01054599|Secondary|To Test the Hypothesis That Treatment With Memantine Will Result in Subjective Improvement of Memory Function, the Change Scores From the QOLIE-89 Will be Evaluated.||5 years||12/2017||||
810773|NCT01054599|Secondary|To Test the Hypothesis That Improvement Will be Selective for Verbal Memory, Change Scores on the Non-verbal Tasks Will be Compared Between the Placebo and Memantine Treatment Groups.||5 years||12/2017||||
810774|NCT01054599|Primary|The Change Scores in Memory Measures From Baseline to Post-treatment/Placebo Will be Compared Between the Memantine Treatment and Placebo Groups.|Change scores from pre- to post-treatment/placebo were calculated for the primary outcome measures, the Selective Reminding Test Continuous Long-Term Retrieval (range 0-72; higher scores indicate better memory) and 7-24 Spatial Recall Test Total Learning (range 0-35; total correct across 5 learning trials are summed, with higher scores indicating better memory) scores. These measures are scores on a scale, rather than representing standard units.|13 weeks|The analysis includes subjects who completed both sessions 1 (baseline) and 2 (post-treatment/placebo). One subject in the memantine group completed both sessions, but the data were excluded from analysis due to seizures occurring during testing sessions 1 and 2, yielding n=8 in the memantine group.||scores on a scale||Standard Deviation|Mean
810775|NCT01054625|Secondary|Apparent Volume of Distribution at Steady State||8 weeks|||L||Geometric Coefficient of Variation|Geometric Mean
810776|NCT01054625|Secondary|Apparent Volume of Distribution During the Terminal Phase||8 weeks|||L||Geometric Coefficient of Variation|Geometric Mean
810777|NCT01054625|Secondary|Clearance||8 weeks|||L/h||Geometric Coefficient of Variation|Geometric Mean
810778|NCT01054625|Secondary|Elimination Half-life||8 weeks|||h||Geometric Coefficient of Variation|Geometric Mean
810779|NCT01054625|Secondary|Area Under Curve 0-21 Days||0-21 days|||h mg/L||Geometric Coefficient of Variation|Geometric Mean
810780|NCT01054625|Secondary|Area Under Curve 0-7 Days||0-7 days|||h mg/L||Geometric Coefficient of Variation|Geometric Mean
810781|NCT01054625|Primary|Maximum Plasma Concentration of Zalutumumab After Fourth Infusion|PK samples are taken: pre and post infusion on days 0, 14, 21 and 28 plus at +3 and +12 hours on days 0 and 28. A single PK sample is taken on days between these treatments and 8 more are taken over 3 weeks after treatment on day 28.|Pre and post infusion after weekly administration of zalutumumab during 28 days|||mg/L||Geometric Coefficient of Variation|Geometric Mean
810782|NCT01054703|Secondary|Efficacy: Improvement in Ethmoid Sinus Health as Demonstrated by CT Scan and Quality-of-life Measures||1 wk, 2wk, 4wk, 6wk||||||
810783|NCT01054703|Primary|Occurrence of Adverse Events at the Time of the Procedure and Cumulatively up to 6 Weeks Post-implant||Procedural and 6 weeks post-implant|||participants|||Number
810784|NCT01054729|Secondary|Percentage of Participants Who Developed Resistance to Sofosbuvir||Baseline to Week 4|Participants in the Safety Analysis Set who received a regimen containing sofosbuvir were analyzed.||percentage of participants|||Number
810785|NCT01054729|Secondary|Plasma Pharmacokinetics of GS-566500: AUCtau at Day 27|The AUCtau of GS-566500 was analyzed at Day 27 (following continuous dosing of sofosbuvir).|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)|Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed.||h*ng/mL||Standard Deviation|Mean
810786|NCT01054729|Secondary|Plasma Pharmacokinetics of GS-566500: AUCinf at Day 0|The AUCinf of GS-566500 was analyzed at Day 0 (following a single dose of sofosbuvir).|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose|Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed.||h*ng/mL||Standard Deviation|Mean
810787|NCT01054729|Secondary|Plasma Pharmacokinetics of GS-566500: Cmax at Day 27|The Cmax of GS-566500 was measured at Day 27 following continuous dosing of sofosbuvir.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)|Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed.||ng/mL||Standard Deviation|Mean
810788|NCT01054729|Secondary|Plasma Pharmacokinetics of GS-566500: Cmax at Day 0|The Cmax of GS-566500 was measured at Day 0 following a single dose of sofosbuvir. GS-566500 is one of the major metabolites of sofosbuvir.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose|Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed.||ng/mL||Standard Deviation|Mean
810789|NCT01054729|Secondary|Plasma Pharmacokinetics of GS-331007: AUCtau at Day 27|The AUCtau of GS-331007 was analyzed at Day 27 (following continuous dosing of sofosbuvir).|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)|Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed.||h*ng/mL||Standard Deviation|Mean
810790|NCT01054729|Secondary|Plasma Pharmacokinetics of GS-331007: AUCinf at Day 0|The AUCinf of GS-331007 was analyzed at Day 0 (following a single dose of sofosbuvir).|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose|Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed.||h*ng/mL||Standard Deviation|Mean
810791|NCT01054729|Secondary|Plasma Pharmacokinetics of GS-331007: Cmax at Day 27|The Cmax of GS-331007 was measured at Day 27 following continuous dosing of sofosbuvir.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)|Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed.||ng/mL||Standard Deviation|Mean
810792|NCT01054729|Secondary|Plasma Pharmacokinetics of GS-331007: Cmax at Day 0|The Cmax of GS-331007 was measured at Day 0 following a single dose of sofosbuvir. GS-331007 is the predominant circulating metabolite of sofosbuvir.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose|Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed.||ng/mL||Standard Deviation|Mean
810793|NCT01054729|Secondary|Plasma Pharmacokinetics of Sofosbuvir: AUCtau at Day 27|"The AUCtau of sofosbuvir was analyzed at Day 27 (following continuous dosing of sofosbuvir).
AUCtau is defined as the concentration of drug (area under the plasma concentration versus time curve) over the dosing interval."|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)|Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed.||h*ng/mL||Standard Deviation|Mean
810794|NCT01054729|Secondary|Plasma Pharmacokinetics of Sofosbuvir: AUCinf at Day 0|"The AUCinf of sofosbuvir was analyzed at Day 0 (following a single dose of sofosbuvir).
AUCinf is defined as the concentration of drug (area under the plasma concentration versus time curve) extrapolated to infinite time."|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose|Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed.||h*ng/mL||Standard Deviation|Mean
810795|NCT01054729|Secondary|Plasma Pharmacokinetics of Sofosbuvir: Cmax at Day 27|The Cmax of sofosbuvir was measured at Day 27 following continuous dosing of sofosbuvir.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)|Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed.||ng/mL||Standard Deviation|Mean
810796|NCT01054729|Secondary|Plasma Pharmacokinetics of Sofosbuvir: Cmax at Day 0|"The Cmax of sofosbuvir was measured at Day 0 following a single dose of sofosbuvir.
Cmax is defined as the maximum concentration of drug."|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose|Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed.||ng/mL||Standard Deviation|Mean
810797|NCT01054729|Secondary|Percentage of Participants With Sustained Virologic Response (SVR) at 12 and 24 Weeks After Last Dose of PEG+RBV Following Completion of 48 Weeks of Treatment|SVR at 12 weeks (SVR12) and 24 weeks (SVR24) was defined as HCV RNA < LOD 12 and 24 weeks after last dose of PEG+RBV, respectively, following completion of 48 weeks of treatment (4 weeks of sofosbuvir or matching placebo and PEG+RBV, followed by an additional 44 weeks of PEG+RBV).|Post-treatment Weeks 12 and 24|Safety Analysis Set||percentage of participants|||Number
810798|NCT01054729|Secondary|Percentage of Participants With Rapid Virologic Response at Week 4|Rapid virologic response (RVR) was defined as HCV RNA below the limit of detection (LOD [15 IU/mL]) at Week 4.|Week 4|Safety Analysis Set||percentage of participants|||Number
810799|NCT01054729|Secondary|Change in Circulating HCV RNA at Week 4||Baseline to Week 4|Safety Analysis Set||log10 IU/mL||Standard Deviation|Mean
810800|NCT01054729|Primary|Percentage of Participants Who Experienced Adverse Events During the Sofosbuvir Treatment Period|Adverse events (AEs) occurring during the sofosbuvir treatment period were summarized across the participant population. A participant was counted once if they had a qualifying event.|Baseline to Week 4|Safety Analysis Set: participants were randomized and received at least 1 dose of study drug||percentage of participants|||Number
810801|NCT01054742|Primary|Number of Participants With Undetectable Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Levels During Part 2 of the Study|A quantitative polymerase chain reaction (PCR) assay was used to measure HCV-RNA.|From Day 1, Week 1 [Part 2 ] through Follow-up Week 24 [ Part 2]|Participants who had relapsed during Part 1 of the study, had detectable HCV-RNA on Day 1, Part 2 of the study, and who consented to retreatment.||participants|||Number
810802|NCT01054820|Secondary|Number of Participants Per Patch Satisfaction Response at the End of Treatment as Assessed by the Investigator|Investigator's assessment of participants' satisfaction with the FLECTOR® Patch rated on a 5-point scale scored as 5=Very Satisfied, 4=Satisfied, 3=No Preference, 2=Dissatisfied, and 1=Very Dissatisfied.|End of Treatment (last visit up to Day 15)|ITT; End-of-Treatment score for patch satisfaction consisted of the last value recorded.||participants|||Number
810803|NCT01054820|Secondary|Number of Participants Per Patch Satisfaction Response at the End of Treatment as Assessed by Participant|Participant satisfaction with the FLECTOR® Patch rated on a 5-point scale scored as 5=Very Satisfied, 4=Satisfied, 3=No Preference, 2=Dissatisfied, and 1=Very Dissatisfied.|End of Treatment (last visit up to Day 15)|ITT; End-of-Treatment score for patch satisfaction consisted of the last value recorded.||participants|||Number
810821|NCT01054911|Secondary|Measurable Disease Response Rate|Positron electron emission tomography (PET) using 18F-fluorodeoxyglucose (FDG) and computed tomography (CT) will be used. None of the participants were analyzed|FDG PET scan at baseline and Week 2, CT scan at baseline and Week 12|Data were not collected.|||||
810804|NCT01054820|Secondary|Mean Change From Baseline to EOT in Beck Depression Inventory® Il|The Beck Depression Inventory® II consisted of 21 items, each with 4 categorical responses ranging from 0 (I do not feel sad) to 3 (I am so sad or unhappy that I can't stand it) with maximum possible score of 63; increase in the number reflected an increase in severity. Total Beck Depression Inventory® II scores classified as follows: 1 to 10=normal ups and downs; 11 to 16=mild mood disturbance; 17 to 20=borderline clinical depression; 21 to 30=moderate depression; 31 to 40=severe depression; and >40=extreme depression.|Baseline, End of Treatment (last visit up to Day 15)|ITT population; End-of-Treatment score was the most recent non-missing value.||scores on a scale||Standard Deviation|Mean
810805|NCT01054820|Secondary|Number of Participants Per Global Pain Relief Scores at the End of Treatment as Assessed by the Investigator|Participants' global pain relief as assessed by investigator using a 5-point scale where 5 = complete relief, 4=a lot of improvement, 3=moderate improvement, 2=slight improvement, and 1=no change.|End of Treatment (up to Day 15)|ITT population||participants|||Number
810806|NCT01054820|Secondary|Number of Participants Per Global Pain Relief Scores at the End of Treatment as Assessed by the Participant|Global pain relief as assessed by participant using a 5-point scale where 5 = complete relief, 4=a lot of improvement, 3=moderate improvement, 2=slight improvement, and 1=no change.|End of Treatment (up to Day 15)|ITT population||participants|||Number
810807|NCT01054820|Secondary|Mean Change From Baseline to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 8: Percent Reduction in Pain From Baseline|Participant-rated instrument to assess functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Question 8: Rate your percent reduction in pain from Baseline (0% = no relief to 100% = complete relief).|Baseline, End of Treatment (last visit up to Day 15)|ITT population; EOT score calculated by taking average of any non-missing scores recorded last 3 days of treatment; if no score on those days, EOT was single, most recent non-missing score recorded on a treatment day. N=number of participants with analyzable data for Question 8 at observation.||percent||Standard Deviation|Mean
810808|NCT01054820|Secondary|Mean Change From Baseline to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 6: Pain Right Now|Participant-rated instrument to assess functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Question 6: Rate your pain right now; rated on an 11 point Likert rating scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine).|Baseline, End of Treatment (last visit up to Day 15)|ITT population; EOT score calculated by taking average of any non-missing scores recorded last 3 days of treatment; if no score on those days, EOT was single, most recent non-missing score recorded on a treatment day.||scores on a scale||Standard Deviation|Mean
810809|NCT01054820|Secondary|Mean Change From Baseline to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 4: Pain at Its Least in the Last 24 Hours|Participant-rated instrument to assess functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Question 4: Rate your pain at its least in the last 24 hours; rated on an 11 point Likert rating scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine).|Baseline, End of Treatment (last visit up to Day 15)|ITT population; EOT score calculated by taking average of any non-missing scores recorded last 3 days of treatment; if no score on those days, EOT was single, most recent non-missing score recorded on a treatment day.||scores on a scale||Standard Deviation|Mean
810810|NCT01054820|Secondary|Mean Change From Baseline to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 3: Pain at Its Worst in the Last 24 Hours|Participant-rated instrument to assess functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Question 3: Rate your pain at its worst in the last 24 hours; rated on an 11 point Likert rating scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine).|Baseline, End of Treatment (last visit up to Day 15)|ITT population; EOT score calculated by taking average of any non-missing scores recorded last 3 days of treatment; if no score on those days, EOT was single, most recent non-missing score recorded on a treatment day.||scores on a scale||Standard Deviation|Mean
810811|NCT01054820|Secondary|Number of Participants With Change From Baseline (Bsl) to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 1: Pain Other Than Everyday Kind of Pain|Participant-rated instrument to assess functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Question 1: Have you had pain other than everyday kinds of pain?; response = Yes or No.|Baseline, End of Treatment (last visit up to Day 15)|ITT population; EOT score was the last non-missing score obtained on a treatment day, including the final treatment visit.||participants|||Number
810812|NCT01054820|Primary|Mean Change From Baseline to End of Treatment (EOT) in Response to Modified Brief Pain Inventory (mBPI) Question 5: Average Pain Over the Last 24 Hours|Participant-rated instrument to assess functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Question 5: Please rate your pain by marking the box beside the number that best describes your pain on the average (over the last 24 hours); rated on an 11 point Likert rating scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine).|Baseline, End of Treatment (last visit up to Day 15)|Intent to Treat (ITT) population: had at least one application of FLECTOR® Patch, pain survey data at Baseline, and at least 1 follow-up visit. EOT score calculated by taking average of any non-missing scores recorded last 3 days of treatment; if no score on those days, EOT was single, most recent non-missing score recorded on a treatment day.||scores on a scale||Standard Deviation|Mean
810813|NCT01054846|Secondary|Incidence Rate of Head and Facial Injuries by Helmet Wearing Status in Helmet Owners|Number of injuries by helmet wearing status as reported|5 months|Analysis population includes all participants that owned a helmet and available data for this assessment||Injuries|||Number
810814|NCT01054846|Primary|Percentage of Participants Wearing Helmet||Baseline (Survey 1) and 5 months (Survey 2)|Analysis reflect population that owned the helmet during each survey||Percentage of Participants|||Number
810822|NCT01054911|Primary|Number of Participants With Adverse Events||6 months|||participants|||Number
810823|NCT01055769|Secondary|Terminal Half-Life (t1/2)|Plasma terminal half-life is the time measured for the plasma concentration to decrease by one half.|0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose|Pharmacokinetic concentration population: all randomized and treated participants who had at least 1 concentration in at least 1 treatment period.||hours||Standard Deviation|Mean
810815|NCT01054885|Secondary|Time to Onset (Increase of 100 Milliliter [mL] From Baseline in 0-4 Hours Post-dose FEV1) on Treatment Day 1|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. Baseline FEV1 is defined as the mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1. Time to onset on Treatment Day 1 is defined as a 100 mL increase from Baseline in FEV1. Time to increase of 100 mL from Baseline was calculated over the 5, 15, 30 minutes, and 1, 2, and 4 hours time points. A participant who had at least one post-dose FEV1 on Day 1, but did not achieve a 100 mL or more increase from Baseline at any scheduled time-point at which FEV1 was assessed up to and including 4 hours was censored.|Baseline and Day 1|Intent-to-Treat (ITT) Population: all randomized participants who received at least one dose of study medication. Only those participants available at the indicated time point were assessed.||Minutes||Full Range|Median
810816|NCT01054885|Secondary|Change From Baseline in Peak Post-dose FEV1 (0-4 Hour) on Day 1|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. BL FEV1 is defined as the mean of the assessments made 30 minutes pre-dose and immediately pre-dose on Day 1. If one of these two assessments was missing then BL was defined as the single pre-dose FEV1 value on Day 1. Peak post-dose FEV1 (0-4 hours) is the maximum post-dose FEV1 recorded over the nominal timepoints of 5, 15 and 30 min, 1, 2 and 4 hours post the Day 1 dose. Change from BL is calculated as the peak post-dose FEV1 (0-4 hour) on Day 1 minus BL FEV1. Analysis performed used an Analysis of Covariance (ANCOVA) model with covariates of treatment, smoking status at screening (stratum), BL - mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1, and centre grouping.|Baseline and Day 1|Intent-to-Treat (ITT) Population: all randomized participants who received at least one dose of study medication. Only those participants available at the indicated time point and without missing covariate information were analyzed.||Liters||Standard Error|Least Squares Mean
810817|NCT01054885|Secondary|Change From Baseline in Chronic Respiratory Disease Questionnaire Self-administered Standardized (CRQ-SAS) Dyspnea Score at Day 168|Considered an ‘Other’ endpoint by FDA. CRQ-SAS measures 4 domains (mastery, fatigue, emotional function, and dyspnea) of functioning of participants with COPD: mastery (amount of control the participant feels he/she has over COPD symptoms); fatigue (how tired the participant feels); emotional function (how anxious/depressed the participant feels); and dyspnea (how short of breath the participant feels during physical activities). Each domain is measured on a scale of 1-7 (1=maximum impairment; 7=no impairment). Each domain score is calculated separately. Current assessment was done only for dyspnea domain. BL scores are the derived scores for each domain and total at Day 1 pre-dose. Change from BL was calculated as the average at each visit minus the BL value. Analysis performed used a repeated measures model with covariates of treatment, smoking status at screening (stratum), BL (derived scores at Day 1 pre-dose), centre grouping, Day, Day by BL and Day by treatment interactions.|Baseline to Day 168|Intent-to-Treat (ITT) Population: all randomized par. who received at least one dose of study medication. Number of par. presented represent those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis||Scores on a scale||Standard Error|Least Squares Mean
810818|NCT01054885|Primary|Change From Baseline in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) FEV1 at Day 169|Co-Primary Endpoint: Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. Trough FEV1 measurements were taken electronically by spirometry on Days 2, 7, 14, 28, 56, 84, 112, 140, 168, and 169. BL was defined as the mean of the assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1.Trough FEV1 was defined as the mean of the FEV1 values obtained 23 and 24 hours after previous morning's dosing. Change from BL was calculated as the average at each visit minus the BL value. Analysis was performed using a repeated measures model with covariates of treatment, smoking status at screening (stratum), BL - mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1, centre grouping, Day, Day by BL and Day by treatment interactions.|Baseline to Day 169|Intent-to-Treat (ITT) Population: all randomized par. who received at least one dose of study medication. Number of par. presented represent those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis||Liters||Standard Error|Least Squares Mean
810819|NCT01054885|Primary|Change From Baseline in Weighted Mean FEV1 Over 0-4 Hours (h) Post-dose at Day 168|Co-Primary Endpoint: Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. Serial FEV1 measurements were taken electronically by spirometry at BL, weeks 2, 8, 12, and 84 (Day 168). Weighted mean (WM) was calculated using the 0 - 4 h post-dose FEV1 measurements that included the pre-dose (Day 1: 30 minutes [min] and 5 min prior to dosing; other serial visits:23 and 24 h after previous morning dose) and post-dose (5, 15, and 30 min and 1, 2, and 4 h) assessments. BL FEV1 is the mean of the two assessments made 30 and 5 min pre-dose at Day 1. WM change from BL was the WM at the visit minus the BL value. Analysis was performed using a repeated measures model with covariates of treatment, smoking status at screening (stratum), BL- mean of the two assessments made 30 and 5 min pre-dose on Day 1, centre grouping, Day, Day by BL and Day by treatment interactions.|Baseline (BL) to Day 168|Intent-to-Treat (ITT) Population: all randomized par. who received at least one dose of study medication. Number of par. presented represent those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis||Liters||Standard Error|Least Squares Mean
810820|NCT01054911|Secondary|Alteration in Diffusion and Vascularity Kinetics|The Response Evaluation Criteria in Solid Tumors (RECIST) criteria may be insensitive in assessing GIST so the Choi criteria will be used. The Choi criteria accounts for morphologic tumor changes and biologic alterations. Diffusion-weighted magnetic resonance imaging (MRI) and dynamic contrast magnetic resonance will be used to find the vascular permeability and apparent diffusion coefficient 9ACD) at baseline, Week 2 and Week 6. Weeks 2 and 6 values will be compared to the baseline values using paired t tests.|MRI at baseline, Week 2 and Week 6|Data were not collected|||||
810870|NCT01056315|Secondary|Brief Pain Inventory Scores: Changes From Baseline to Day 8, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99, and Day 113 (Final Visit).||Baseline, weekly mean||||||
810824|NCT01055769|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)|The time of the first occurrence of peak concentration observed directly from data.|0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose|Pharmacokinetic concentration population: all randomized and treated participants who had at least 1 concentration in at least 1 treatment period.||hours||Full Range|Median
810825|NCT01055769|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose|Pharmacokinetic concentration population: all randomized and treated participants who had at least 1 concentration in at least 1 treatment period.||mcg*h/mL||Standard Deviation|Mean
810826|NCT01055769|Primary|Maximum Observed Plasma Concentration (Cmax)|Maximum observed plasma concentration within the dosing interval was directly obtained from the concentration-time data.|0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose|Pharmacokinetic concentration population: all randomized and treated participants who had at least 1 concentration in at least 1 treatment period.||microgram/milliliter (mcg/mL)||Standard Deviation|Mean
810827|NCT01055769|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration-time curve from time zero (pre-dose) to the time of the last measurable concentration (AUClast).|0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose|Pharmacokinetic concentration population: all randomized and treated participants who had at least 1 concentration in at least 1 treatment period.||microgram*hour/milliliter (mcg*h/mL)||Standard Deviation|Mean
810828|NCT01055782|Secondary|Perception of Pain|VAS (Visual Analogue Scale), 0 - 10. VAS 0 is no pain, VAS 10 is max pain. Scores on a scale|After endoscopy (within 10mins) and 1 day after endoscopy|||Scores on a scale 0-10||Standard Deviation|Mean
810829|NCT01055782|Primary|Completed Colonoscopy||immediately after colonoscopy|Choosen by randomization.||participants|||Number
810830|NCT01055834|Primary|Pharmacokinetic Parameter (Food Effect): Area Under the Plasma Concentration- Time Curve From Time 0 to Time 24 Hours (AUC[0-24])|Pharmacokinetic parameter: Area under the plasma concentration- time curve from time 0 (administration of the drug) to time 24 hours was measured in order to investigate the effect of food. AUC was measured in nanogram hours per milliliter (ng*h/mL) and was measured under fasted and fed conditions. Blood sampling was calculated immediately before administration of the study drug and 24 hours after administration of the study drug (0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose).|immediately before administration & 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose|Pharmacokinetic analysis set (food effect): 14 participants who completed both Period II and Period III, who had been assigned to move on to Period III when assigned to treatment groups.||ng*hr/mL||Standard Deviation|Mean
810831|NCT01055834|Primary|Pharmacokinetic Parameter (Food Effect): Maximal Drug Concentration (Cmax)|Pharmacokinetic parameter: maximal drug concentration (Cmax) was measured in order to investigate the effect of food. Cmax was measured in nanograms per milliliter (ng/mL) and was measured under fasted and fed conditions. Blood sampling was calculated immediately before administration of the study drug and 24 hours after administration of the study drug (0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose).|immediately before administration & 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose|Pharmacokinetic analysis set (food effect): 14 participants who completed both Period II and Period III, who had been assigned to move on to Period III when assigned to treatment groups.||ng/mL||Standard Deviation|Mean
810832|NCT01055834|Primary|Pharmacokinetic Parameter (Bioequivalence): Area Under the Plasma Concentration- Time Curve From Time 0 to Time 24 Hours (AUC[0-24])|Pharmacokinetic parameter: Area under the plasma concentration- time curve from time 0 (administration of the drug) to time 24 hours was measured in order to confirm bioequivalence. AUC was measured in nanogram hours per milliliter (ng*h/mL). Blood sampling was calculated immediately before administration of the study drug and 24 hours after administration of the study drug (0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose).|immediately before administration & 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose|Pharmacokinetic analysis set (bioequivalence set): All participants who completed the study and had their samples analyzed, except for one participant in Group A who discontinued the study in Period 1.||ng*h/mL||Standard Deviation|Mean
810833|NCT01055834|Primary|Pharmacokinetic Parameter (Bioequivalence): Maximal Drug Concentration (Cmax)|Pharmacokinetic parameter: maximal drug concentration (Cmax) was measured in order to confirm bioequivalence. Cmax was measured in nanograms per milliliter (ng/mL). Blood sampling was calculated immediately before administration of the study drug and 24 hours after administration of the study drug (0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose).|immediately before administration & 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose|Pharmacokinetic analysis set (bioequivalence set): All participants who completed the study and had their samples analyzed, except for one participant in Group A who discontinued the study in Period 1.||ng/mL||Standard Deviation|Mean
810834|NCT01055886|Other Pre-specified|Diary Ratings of Cravings|"Participants provided (through ecological momentary assessment) ratings of their smoking craving. This outcome reflects differences between ad lib (or typical) smoking craving compared to smoking craving reported during the pre-quit period. Craving was reported from a single item Please indicate your desire/craving to smoke, and answers were provided in a 5-point Likert scale where 1=no craving and 5=severe craving. Higher scores are presumed to be worse because they indicate increased craving, which is likely to lead to non-abstinence."|During pre-quit period; two weeks|61 participants provided this EMA data during the pre-quit period.||units on a scale||Standard Error|Mean
810835|NCT01055886|Secondary|Abstinence as Measured by Exhaled Carbon Monoxide (CO)|This outcome reflects the number of participants whose exhaled carbon monoxide (CO; a measure of smoking) indicated abstinence (i.e., 6 parts per million or less) at Session 12, which occurred six weeks post-quit.|Session 12, 6 weeks post-quit|Data was available on 30 participants who attended Session 12.||participants|||Number
810836|NCT01055886|Primary|Participants Self-reporting Abstinence During 6 Weeks Post Quit|In the 6 week post-quit period, participants completed ecological momentary assessment (EMA), or diary, ratings of their smoking behavior. This outcome reflects the number of participants who reported not relapsing (i.e., smoking 7 days in a row) during the 6 weeks post-quit.|6 weeks post-quit (from quit date to Session 12); evaluated weekly from Session 7 to Session 12|37 participants completed the ecological momentary assessment (EMA; diary) ratings during the post-quit period.||participants|||Number
810837|NCT01056016|Primary|Physician ADHD Practice Behavior|Percentage of patients across pediatricians in each randomized group for whom the pediatrician collected teacher ratings to monitor treatment response|Baseline and 6 months|Patient chart reviews were conducted with 174 patients in the ADHD Collaborative Intervention group and 64 patients in the Wait-list control group||percentage of patients||Standard Deviation|Mean
810838|NCT01056107|Secondary|Stool Consistency Post Treatment|"The subjects rated their stool consistency using the 7-point Bristol Stool Scale. The Bristol Stool Scale is a medical aid designed to classify the form of human feces into seven categories or types. Types 1 and 2 indicate constipation with 3 and 4 being the ideal stools especially the latter, as they are the easiest to defecate, and 5-7 tending towards diarrhea. The Bristol stool form was part of the bowel pattern diary, which was dispensed at the screening visit, and the completed bowel pattern diary was collected at the completion of the study."|34 days (Visit 6)|Intent-to-treat||units on a scale||Standard Error|Mean
810839|NCT01056107|Secondary|Stool Frequency|Stool frequency was self reported in a Bowel Pattern Diary. The bowel pattern diary was dispensed at the screening visit, and the completed bowel pattern diary was collected at the completion of the study.|screening visit (Visit 1), 34 days (Visit 6)|Intent-to-treat||Stools/day||Standard Error|Mean
810840|NCT01056107|Secondary|Colonic Transit, Colonic Geometric Center at 48 h Measured by Scintigraphy, as Compared to Placebo.|The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.|48 hours (Visit 4 = Day 2)|Intent-to-treat||units on a scale||Standard Error|Mean
810841|NCT01056107|Secondary|Ascending Colon Emptying Half-time (AC t1/2) Measured by Scintigraphy|Ascending colon emptying half-time will be estimated by power exponential analysis of the proportionate emptying over time of counts from the colon. The primary data for this analysis will be the proportion of decay and depth-corrected counts in the ascending colon on the hourly scans on the first day of transit measurement and the 48 hour data.|48 hours (Visit 4 = Day 2)|Intent-to-treat||hours||Standard Error|Mean
810842|NCT01056107|Secondary|Colonic Filling at 6 h Measured by Scintigraphy|Percent of the radio-labeled meal that reached the colon at 6 hours, indirectly reflecting small bowel transit time.|6 hours (Visit 2 = Day 0)|Intent-to-treat||percentage of meal||Standard Error|Mean
810843|NCT01056107|Secondary|Colonic Geometric Center at 4 h Measured by Scintigraphy|"The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool. (Note: when there is no radio isotope in the colon (e.g., at 4 hours) the geometric center values are recorded as zero, thus the mean values can be less than one.)"|4 hours (Visit 2 = Day 0)|Intent-to-treat||units on a scale||Standard Error|Mean
810844|NCT01056107|Secondary|Gastric Residual at 2 and 4 Hours Measured by Scintigraphy|The gastric residual will be calculated as the proportion of isotope remaining in the stomach (at 2 and 4 hours).|2 hours, 4 hours (Visit 2 = Day 0)|Intent-to-treat||proportion of isotope in the stomach||Standard Error|Mean
810845|NCT01056107|Primary|Half Time (t1/2) of Gastric Emptying of Solids Measured by Scintigraphy (Gastric Transit)|Half time (t1/2) of gastric emptying (GE) of solids is the time for half of the ingested solids or liquids to leave the stomach. The scintigraphy for GE t1/2 was done on Visit 2 (Day 0 of the study), the first day of scintigraphy.|approximately 2 hours after radiolabeled meal is ingested (Visit 2 = Day 0)|Intent-to-treat||minutes||Standard Error|Mean
810846|NCT01056107|Primary|Change Between Postprandial and Fasting Whole Gastric Volume by Technetium-99m (99mTc)-SPECT Imaging (Gastric Accommodation)|"A noninvasive SPECT method was used to measure gastric volume during fasting and 32 min after a liquid nutritional supplement meal. Subjects reported to the clinic after an overnight fast. 99mTC was giving by an intravenous injection in the forearm. The first fasting scan was obtained, and the study medication was given s.c. After 10 min, a 2nd fasting post medication scan was obtained, and the meal consumed; then two serial postprandial scans were obtained. Each scan required 9-12 min. Tomographic images of the gastric wall were obtained throughout the long axis of the stomach using a dual-head gamma camera that rotates around the body. This allows assessment of the radiolabeled circumference of the gastric wall, rather than the intragastric content. For this outcome measure, the scans for the fasting volume and 2 postprandial volumes were used. The 2 postprandial (PP) volumes were averaged. Change was calculated as (PP - Fasting = gastric accommodation)."|approximately 1 hour after 99mTC injection, approximately 30 min after liquid meal (Visit 5 = approximately 2-10 days after Visit 4)|Intent-to-treat||mL||Standard Error|Mean
810847|NCT01056107|Primary|Colonic Transit, Colonic Geometric Center at 24 Hours|The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.|24 hours (Visit 3 = Day 1)|Intent-to-treat||units on a scale||Standard Error|Mean
810848|NCT01056198|Post-Hoc|Change From Baseline in Wound Area - Control Group|Wound area at the end of treatment visit compared to the wound area at baseline for each subject|baseline and 28 days|Intent-to-treat||square centimeters||Standard Deviation|Mean
810849|NCT01056198|Post-Hoc|Change From Baseline in Wound Area - Santyl Treatment Group|Wound area at the end of treatment visit compared to the wound area at baseline for each subject|baseline and 28 days|Intent-to-treat||square centimeters||Standard Deviation|Mean
810850|NCT01056198|Secondary|Percent of Wound Area Change From Baseline at the End of 12 Week Follow-up||baseline and 84 days|Intent-to-Treat population||percentage of baseline wound area||Standard Error|Mean
810851|NCT01056198|Secondary|Percent of Wound Area Change From Baseline at End of Treatment||baseline and 28 days|Intent-to-Treat population||percentage of baseline wound area||Standard Error|Mean
810852|NCT01056198|Primary|Bates-Jensen Wound Assessment Score - Modified (BWAT-m)|The Bates-Jensen Wound Assessment Score was used to collect information about the wound bed appearance in each of 8 categories (sub-scales) each with a possible score of 1 to 5. For each sub-scale intact skin was scored a one (1) while a five (5) would indicate the worst possible rating. All scores were combined to compute a total score for each arm/group, with a score of 8 indicating intact skin (minimum summed score), and a score of 40 indicating the worst possible rating (maximum summed score).|baseline and 28 days|Intent-to-Treat population||units on a scale||Standard Deviation|Mean
810853|NCT01056263|Primary|Overall Survival (OS)|Overall survival is the duration from first dose of study medication to death. For participants who are alive, overall survival is censored at the last contact.|Baseline until death or up to Year 5|Full analysis set included all participants who received at least 1 dose of axitinib (AG-013736).||Days||95% Confidence Interval|Median
810854|NCT01056276|Secondary|Overall Response Rate|The number of patients with observed complete or partial response (CR or PR) assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria. PR=50% or greater reduction from baseline in serum M-protein and 90% or greater reduction from baseline in 24-hour urinary M-protein.|every 4 weeks for approximately 2 years|All patients evaluable for response.||participants|||Number
810855|NCT01056276|Secondary|Overall Survival|Defined as the interval of time, in months, from first study treatment until the earlier of the date of death or date last known alive.|every 4 weeks until progressive disease then every 12 weeks, projected 48 months|All patients evaluable for response.||months||95% Confidence Interval|Median
810856|NCT01056276|Secondary|Progression Free Survival|Defined as the interval of time (in months) that patient are alive from date of first protocol treatment to date of documented tumor progression or date of death from any cause. Progressive disease, assessed according to International Myeloma Working Group Uniform Response Criteria, is defined as at least a 25% increase from the nadir in any one of the following criteria: serum M-protein, urine M-protein, or bone marrow plasma cell percentage of 10% or greater.|every 8 weeks for up to 48 months|||months||Full Range|Median
810857|NCT01056276|Primary|Number of Patients Who Experienced Serious and Non-serious Adverse Events|All serious adverse events (SAEs) and non-serious adverse events (AEs) were assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0, and were collected from start of study treatment until 30 days after last dose of study medication. Refer to the Adverse Event module for specific terms.|approximately 36 weeks|All patients who received at least one dose of BBD treatment.||participants|||Number
810858|NCT01056276|Primary|Complete Response Rate|Defined as the percent of patients having a complete response (CR) to treatment, assessed using the International Myeloma Working Group (IMWG) Uniform Response Criteria. CR=disappearance of soft tissue plasmacytomas and 5% or less plasma cells in bone marrow.|every 8 weeks for approximately 48 months|All patients evaluable for response.||percentage of participants|||Number
810859|NCT01056289|Secondary|Percentage of Participants Who Were Unable to Successfully Complete Tapering of the Study Drug Because of the Number and/or Severity of Their Discontinuation Symptoms|Discontinuation symptoms may occur following abrupt cessation of serotonergic antidepressants in a minority of participants following short-term treatment of an episode of Major Depressive Disorder (MDD). The symptoms include emotional and somatic symptoms such as dizziness, nausea, and paresthesia and typically appear within 2 to 3 days of reducing the dose or stopping the antidepressant medication. Discontinuation symptoms are usually mild and resolve spontaneously within a week in the majority of patients, though a minority can have intense and prolonged symptoms.|Double-blind phase: Baseline (Study Day 168) up to Week 4 (Study Day 196)|Safety population||percentage of participants|||Number
810860|NCT01056289|Secondary|Percentage of Participants With Taper Adverse Events (AEs) in the Double-blind Phase|Any untoward medical occurrence in a patient who received study drug was considered an AE without regard to possibility of causal relationship. Taper-emergent AEs (TPAEs) are those events which occurred during the double-blind period but did not occur during the last 7 days of the on-therapy period or existed during the last 7 days and worsened in the double-blind period.|Double-blind phase: Baseline (Study Day 168) up to Week 4 (Study Day 196)|Safety population (Double-blind phase): all participants who received at least 1 dose of study treatment and were randomized into the Double-blind treatment phase.||percentage of participants|||Number
810861|NCT01056289|Primary|Total Discontinuation - Emergent Signs and Symptoms (DESS) Score Over the First 2 Weeks of the Double-blind Phase|Clinician-administered 43-item assessment to evaluate discontinuation-emergent symptoms resulting from withdrawal from study treatment. Total score=sum of number of new symptoms and old (but worse) symptoms (score=1) and old and unchanged symptom, absent, or old symptom but improved (score=0); total possible range 0 to 43. Higher score=more symptoms. New symptom=any symptom that appeared within 7 days before DESS administration; old symptom=any symptom that appeared 7 days before DESS administration and continued into 7-day period. DESS calculated as 2*mean(of DESSDB Week 1, DESSDB Week 2).|Double-blind phase: Week 1 (Study Day 175), Week 2 (Study Day 182)|Full Analysis Set (FAS): all randomized participants who had at least 1 postrandomization DESS record. Mean was adjusted for baseline DESS score and study center.||scores on a scale||Standard Error|Mean
810862|NCT01056315|Secondary|Assessment of Rescue Medication Usage During the 4-week Titration.||4-week titration phase||||||
810863|NCT01056315|Secondary|Time to Treatment Discontinuation Due to Lack of Efficacy.||Baseline to time to treatment discontinuation||||||
810864|NCT01056315|Secondary|Hospital Anxiety and Depression Scale: Changes From Baseline to Day 29, Day 71 and Day 113 (Final Visit).||Baseline, Day 29, Day 71 and Day 113.||||||
810865|NCT01056315|Secondary|Assessment of Each Item of the Leeds Sleep Evaluation Questionnaire: Changes From Baseline to Day 29, Day 71 and Day 113 (Final Visit).||Baseline, Day 29, Day 71 and Day 113.||||||
810866|NCT01056315|Secondary|EuroQol-5 Dimension Health Questionnaire: Changes From Baseline to Day 29, Day 71 and Day 113 (Final Visit).||Baseline, Day 29, Day 71 and Day 113.||||||
810867|NCT01056315|Secondary|Short Form 36 Health Survey (SF-36®): Changes From Baseline to Day 29, Day 71 and Day 113 (Final Visit).||Baseline, Day 29, Day 71 and Day 113.||||||
810868|NCT01056315|Secondary|Patient Global Impression of Change Using a 7-point Verbal Rating Scale, on Day 29, Day 71 and Day 113 (Final Visit).||Day 29, Day 71 and Day 113.||||||
810869|NCT01056315|Secondary|Neuropathic Pain Symptoms Inventory: Changes From Baseline to Day 8, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99 and Day 113 (Final Visit)||Baseline, weekly mean||||||
810874|NCT01056315|Secondary|Proportion of Subjects Achieving Various Levels of Pain Improvement (Including 30% and 50%) Based on the Percent Change From Baseline to the Last 7 Days of the 12-week Maintenance on an 11-point NRS (Responder Analysis).||Baseline, Last 7 days of 12-week maintenance||||||
810875|NCT01056315|Secondary|Change From Baseline in the Mean of the Daily Average Pain Intensity Scores (on an 11-point NRS) Over the Entire 12-week Maintenance||Baseline, Daily scores over entire 12 week maintenance||||||
810876|NCT01056315|Primary|Average Pain Intensity|The primary efficacy endpoint is the change from baseline in the mean of the daily average pain intensity scores (on an 11-point NRS) over the last 7 days of the 12-week maintenance (Week 16).|Baseline; last 7 days of 12-week maintenance||||||
810877|NCT01056328|Secondary|Early Onset (Within 90 Days) of SAE/Non-serious AEs and Late Onset (After 90 Days) SAEs|Early onset (within 90 days) of Serious Adverse Events (SAE)/Non-serious Adverse Events (AEs) and late onset (after 90 days) Serious Adverse Events (SAEs)|12 months|||participants|||Number
810878|NCT01056328|Secondary|Documented (> 30 Seconds) Asymptomatic Episodes of Atrial Fibrillation (AF), Atrial Flutter (AFL), or Atrial Tachicardia (AT) After the Blanking Period||12 months|||participants|||Number
810879|NCT01056328|Primary|Incidence of Adverse Events Included in the Pre-specified Composite.||12 months|||participants|||Number
810880|NCT01056328|Primary|Incidence of Adverse Events Included in the Pre-specified Composite|Atrial perforation, atrio-esophageal fistula, cardiac tamponade, cerebrovascular accident, death, diaphragmatic paralysis, hospitalization, myocardial infarction, pericaridal effusion, pericarditis, pulumonary edema, pulmonary vein stenosis, thromboembolism, transient ischemic attack, and vascular access complications.|7 days|||participants|||Number
810881|NCT01056328|Primary|Confirmation of Entrance Block in the Pulmonary Veins||20 minutes after initial isolation|||participants|||Number
810882|NCT01056341|Secondary|Success/Failure Based on the Investigator Qualitative Assessment of Complete Resolution at W48.|Time to first sustained improvement based on centralized qualitative assessments of paired patient-visits|6 months||||||
810883|NCT01056341|Primary|Primary Analysis : Complete/Nearly Complete Resolution of the Target Infantile Hemangioma at W24 Compared to Baseline Based on the Intra-patient Blinded Centralized Independent Qualitative Assessments of W24 Photographs.||6 months|After the interim analysis results, the Independent Committee recommendations was to continue the trial with the 3 mg/kg/day6 months arm and the placebo arm. 55 randomized and treated patients in the placebo arm and 102 randomized patients in the 3 mg/kg/day6 months arm,1 was not treated because no unit of the assigned treatment available on site.||percentage of participants|||Number
810884|NCT01056341|Primary|Interim Analysis : Complete/Nearly Complete Resolution of the Target Infantile Hemangioma at Week 24 Compared to Baseline Based on the Intra-patient Blinded Centralized Independent Qualitative Assessments of Week 24 Photographs.||6 months|Among the 190 first randomized patients who entered the stage 1 of the study, 2 patients were not treated because of parent'/legal guardian's decision: 1 in the 1mg/kg/day 6 months arm and 1 in the 3 mg/kg/day 3 months arm.||percentage of participants|||Number
810885|NCT01056380|Secondary|Change in Influenza Virus Titer Assessed by Quantitative RT-PCR (Subjects With Confirmed Influenza)||4 days|All subjects with laboratory confirmed influenza enrolled in the intensive virologic follow up substudy who received at least one dose of study medication.||Quantitative PCR RNA Copies||Standard Deviation|Mean
810886|NCT01056380|Secondary|Time to Cessation of Viral Shedding (Subjects With Confirmed Influenza)||28 days|All subjects with laboratory confirmed influenza enrolled in the intensive virologic follow up substudy who received at least one dose of study medication.||hours||Inter-Quartile Range|Median
810887|NCT01056380|Secondary|Complications of Influenza Including Secondary Illnesses, Antibiotic Use and Hospitalizations (Subjects With Confirmed Influenza)||Up to 28 days|All subjects with laboratory confirmed influenza who received at least one dose of study medication.||Participants|||Count of Participants
810888|NCT01056380|Secondary|Time Lost From Work (Subjects With Confirmed Influenza)||Up to 28 days|All subjects with laboratory confirmed influenza who received at least one dose of study medication.||hours||95% Confidence Interval|Least Squares Mean
810889|NCT01056380|Secondary|Severity of Disease Expressed in Score-hours (Symptom Scores Multiplied by Duration of Symptoms in Hours)|Subjects recorded symptom severity as absent, mild, moderate, or severe (0-3, respectively) twice daily for at least seven days. The average severity score for each symptom was multiplied by the duration of the time period to which the score applied to arrive at score-hours for that period. For example, if a symptom was graded as ‘2’ at 8:00 AM and ‘1’ at 8:30 PM of the same day, the average score for that time period was 1.5, the time period was 12.5 hours, and the calculated number of score-hours for that period was 18.75. The score-hours for each time period were added and divided by the total number of hours.|Up to 28 days|All subjects with laboratory confirmed influenza who received at least one dose of study medication.||symptom severity score *hours*||Standard Deviation|Mean
810890|NCT01056380|Secondary|Time to Return to Normal Daily Activity (Subjects With Confirmed Influenza)||Up to 28 days|All subjects with laboratory confirmed influenza who received at least one dose of study medication.||hours||Inter-Quartile Range|Median
810891|NCT01056380|Secondary|Time to Resolution of All Clinical Symptoms of Influenza (All Treated Subjects)||Up to 28 days|All subjects who received at least one dose of study medication.||hours||Inter-Quartile Range|Median
810892|NCT01056380|Secondary|Time to Resolution of All Clinical Symptoms of Influenza (Subjects Infected With Any Respiratory Virus)||Up to 28 days|All subjects with any laboratory confirmed viral infection who took at least one dose of study medication.||hours||Inter-Quartile Range|Median
810893|NCT01056380|Primary|Time to Resolution of All Clinical Symptoms of Influenza (Subjects With Confirmed Influenza Infection)||Up to 28 days|All subjects with laboratory confirmed influenza who took at least one dose of study medication.||hours||Inter-Quartile Range|Median
810894|NCT01056484|Primary|Time to Relapse (Resumption of Drinking)|Alcohol consumption as measured by time to relapse (resumption of drinking) from baseline to 26 weeks.|26 weeks|Only 105 participants provided data for this measure at 26-week follow up; due to participants either: declining participation for the visit, being unable to reach within the 26-week follow up time, or withdrawing from the study before 26-week follow up. Of the 105, 3 meditation/0 controls met criteria for having relapsed during this time frame.||number of days to relapse||Standard Deviation|Mean
831850|NCT01243320|Primary|Change In Total Protein Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days|||g/dL||95% Confidence Interval|Mean
810895|NCT01056484|Primary|Percent Days Abstinent From Alcohol|Measures percent days abstinent from alcohol|26 weeks|Only 105 participants provided data for this measure for the 26-week follow up visit. This was due to participants not providing data as a result of either: declining participation for that visit, being unable to reach within the 26-week follow up time frame, or withdrawing from the study before the 26-week follow up visit.||percent of days abstinent from alcohol||Standard Deviation|Mean
810896|NCT01056484|Secondary|Subject Treatment Adherence|Mindfulness Based Relapse Prevention for Alcohol Dependence intervention session attendance; adherence defined as attending 4 or more out of 8 total sessions.|8 weeks|"Of 64 enrolled participants, one withdrew prior to the first intervention session. This participant's data was included in the baseline data analyses; this participant's meditation intervention attendance was counted as 0."||Percentage of meditation participants|||Number
810897|NCT01056484|Secondary|Subject Treatment Satisfaction|Treatment satisfaction rating on a Likert scale of 1 to 7 (1 indicating 'extremely dissatisfied', 4 'neutral', and 7 'extremely satisfied').|8 weeks|48 participants provided data for this outcome measure at an 8-week follow up visit, and their responses were analyzed.||points||Standard Deviation|Mean
810898|NCT01056484|Secondary|Drinker Inventory of Consequences|Severity of drinking related negative consequences as measured by the Drinker Inventory of Consequences (DrInC-2R). This inventory consists of 50 items rated on a scale of 0 to 3, with '0' indicating a given consequence did not happen, '1' indicating it almost happened, '2' indicating it did happen, and '3' indicating it happened more than once. The sum of all ratings (minus the 5 control questions) indicates the 'total score', with higher scores corresponding to more drinking related consequences. The 'total score' can range from 0 (did not happen) to 135 (happened all the time).|26 weeks|Only 98 participants provided data for this measure for the 26-week follow up visit. This was due to participants not providing data as a result of either: declining participation for that visit, being unable to reach within the 26-week follow up time frame, or withdrawing from the study before the 26-week follow up visit.||Scores on a scale||Standard Deviation|Mean
810899|NCT01056484|Primary|Percent Heavy Drinking Days|Alcohol consumption as measured by percent heavy drinking days from baseline to 26 weeks. A heavy drinking day is defined as 4 or more drinks for women or 5 or more drinks for men, during a 24-hour period.|26 weeks|Only 105 participants provided data for this measure for the 26-week follow up visit. This was due to participants not providing data as a result of either: declining participation for that visit, being unable to reach within the 26-week follow up time frame, or withdrawing from the study before the 26-week follow up visit.||percentage of heavy drinking days||Standard Deviation|Mean
810900|NCT01056510|Secondary|Proportion of Malignant B-cells in Normal B-cells Among Participants With a Positive Outcome for MRD in the First-Line Subpopulation|The proportion of malignant B-cells in normal B-cells was quantitatively determined, and was calculated as the number of malignant B-cells divided by the number of normal B-cells observed.|After 6 treatment cycles (up to 24 weeks)|ITT Population (First-Line Subpopulation); only participants with a positive outcome for MRD were included in the analysis.||proportion||Standard Deviation|Mean
810901|NCT01056510|Secondary|Number of Participants With Positive and Negative Outcome for MRD in the First-Line Subpopulation|Negative MRD was defined as a proportion of malignant B-cells in normal B-cells < 0.0001, and positive MRD was defined as a proportion of malignant B-cells in normal B-cells >/= 0.0001.|After 6 treatment cycles (up to 24 weeks)|ITT Population (First-Line Subpopulation); only participants with available MRD data (MRD-evaluable participants) were included in the analysis.||participants|||Number
810902|NCT01056510|Secondary|Percentage of Participants Achieving Molecular Response in the First-Line Subpopulation|Molecular response was defined as negative minimal residual disease (MRD) during study treatment or within 4 months after the end of treatment. Negative MRD was defined as a proportion of malignant B-cells in normal B-cells < 0.0001. The percentage of participants achieving molecular response was calculated as the number of participants with negative MRD divided by the number of participants analyzed.|Up to 4 months after the last treatment cycle (up to 40 weeks)|ITT Population (First-Line Subpopulation); only participants with a tumor response of CR, CRi, PR, or nPR during study treatment or within 4 months after the end of treatment were considered in the analysis.||percentage of participants|||Number
810903|NCT01056510|Secondary|Overall Survival (OS) in the First-Line Subpopulation|OS was defined as the time from recorded diagnosis to death from any cause. OS was calculated in months as [death date or last-known alive date minus diagnosis date plus 1] divided by 30.44.|End of Cycles 3 and 6 (both treatment arms), end of Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks as confirmation of response, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years)|ITT Population (First-Line Subpopulation)||months||95% Confidence Interval|Median
810904|NCT01056510|Secondary|Percentage of Participants Experiencing Death in the First-Line Subpopulation|The percentage of participants experiencing death was calculated as the number of participants with event divided by the number of participants analyzed, multiplied by 100.|End of Cycles 3 and 6 (both treatment arms), end of Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks as confirmation of response, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years)|ITT Population (First-Line Subpopulation)||percentage of participants|||Number
810905|NCT01056510|Secondary|Duration of Response in the First-Line Subpopulation|The criteria for CR, CRi, PR, nPR, and PD are identified in previous outcome measure(s). Duration of response was defined as the time from the first assessment of CR, CRi, PR, or nPR to the first documentation of PD or death, whichever occurred first. Duration of response was calculated in months as [first event date minus first assessment date of CR/CRi/PR/nPR plus 1] divided by 30.44.|End of Cycles 3 and 6 (both treatment arms), end of Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks as confirmation of response, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years)|ITT Population (First-Line Subpopulation); only participants with a tumor response of CR, CRi, PR, or nPR were considered in the analysis.||months||95% Confidence Interval|Median
810923|NCT01056523|Secondary|Overall Response Rate|Overall response rate comprises complete response (<5% blasts in the bone marrow, and in the peripheral blood Hgb more than or equal to 100 g/L, platelets more than or equal to 100x10-9/L, and neutrophils more than or equal to 1x10-9/L), partial response (5 to 25% blasts in the bone marrow and same peripheral blood parameters) and blast response (a greater than 50% decrease in bone marrow blast count and 2 log reduction in peripheral blood blast count, sustained for at least 28 days).|2-3 years|Only patients treated for 28 days or more were evaluable for response.||Participants|||Count of Participants
810906|NCT01056510|Secondary|Percentage of Participants With Tumor Response of CR, CRi, PR, or nPR Experiencing PD or Death in the First-Line Subpopulation|The criteria for CR, CRi, PR, nPR, and PD are identified in previous outcome measure(s). The percentage of participants experiencing PD or death was calculated as the number of participants with event divided by the number of participants analyzed, multiplied by 100.|End of Cycles 3 and 6 (both treatment arms), end of Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks as confirmation of response, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years)|ITT Population (First-Line Subpopulation); only participants with a tumor response of CR, CRi, PR, or nPR were considered in the analysis.||percentage of participants|||Number
810907|NCT01056510|Secondary|Time to Next Leukemia Treatment (TNLT) in the First-Line Subpopulation|TNLT was defined as the time from the first dose of trial treatment to the first documentation of any new leukemia treatment. TNLT was calculated in months as [first new treatment date minus first dose date plus 1] divided by 30.44.|During Cycles 1 to 6 (both treatment arms), Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years)|ITT Population (First-Line Subpopulation)||months||95% Confidence Interval|Median
810908|NCT01056510|Secondary|Percentage of Participants With Documented Intake of New Leukemia Therapy in the First-Line Subpopulation|The percentage of participants with documented intake of new (post-trial) leukemia therapy was calculated as the number of participants with new therapy divided by the number of participants analyzed, multiplied by 100.|During Cycles 1 to 6 (both treatment arms), Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years)|ITT Population (First-Line Subpopulation)||percentage of participants|||Number
810909|NCT01056510|Secondary|Event-Free Survival (EFS) in the First-Line Subpopulation|The criteria for PD and SD are identified in previous outcome measure(s). EFS was defined as the time from the first dose of trial treatment to the first documentation of PD, the beginning of new treatment for any hematologic malignancy, or death from any cause. Those with SD were considered event-free. EFS was calculated in months as [first event date minus first dose date plus 1] divided by 30.44.|End of Cycles 3 and 6 (both treatment arms), end of Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks as confirmation of response, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years)|ITT Population (First-Line Subpopulation)||months||95% Confidence Interval|Median
810910|NCT01056510|Secondary|Percentage of Participants Experiencing PD, Documented Intake of New Leukemia Therapy, or Death in the First-Line Subpopulation|The criteria for PD are identified in previous outcome measure(s). The percentage of participants experiencing PD, intake of new (post-trial) leukemia therapy, or death was calculated as the number of participants with event divided by the number of participants analyzed, multiplied by 100.|End of Cycles 3 and 6 (both treatment arms), end of Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks as confirmation of response, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years)|ITT Population (First-Line Subpopulation)||percentage of participants|||Number
810911|NCT01056510|Secondary|Disease-Free Survival (DFS) in the First-Line Subpopulation|The criteria for CR, CRi, and PD are identified in previous outcome measure(s). DFS was defined as the time from the first assessment of CR or CRi to the first documentation of PD or death, whichever occurred first. DFS was calculated in months as [first event date minus first assessment date of CR/CRi plus 1] divided by 30.44.|End of Cycles 3 and 6 (both treatment arms), end of Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks as confirmation of response, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years)|ITT Population (First-Line Subpopulation); only participants with a tumor response of CR or CRi during study treatment or within 4 months after the end of treatment were considered in the analysis.||months||95% Confidence Interval|Median
810912|NCT01056510|Secondary|Percentage of Participants With Tumor Response of CR or CRi Experiencing PD or Death in the First-Line Subpopulation|The criteria for CR, CRi, and PD are identified in previous outcome measure(s). The percentage of participants experiencing PD or death was calculated as the number of participants with event divided by the number of participants analyzed, multiplied by 100.|End of Cycles 3 and 6 (both treatment arms), end of Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks as confirmation of response, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years)|ITT Population (First-Line Subpopulation); only participants with a tumor response of CR or CRi during study treatment or within 4 months after the end of treatment were considered in the analysis.||percentage of participants|||Number
810913|NCT01056510|Secondary|Progression-Free Survival (PFS) in the First-Line Subpopulation|The criteria for PD are identified in previous outcome measure(s). PFS was defined as the time from the first dose of trial treatment to the first documentation of PD or death, whichever occurred first. PFS was calculated in months as [first event date minus first dose date plus 1] divided by 30.44.|End of Cycles 3 and 6 (both treatment arms), end of Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks as confirmation of response, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years)|ITT Population (First-Line Subpopulation)||months||95% Confidence Interval|Median
810914|NCT01056510|Secondary|Percentage of Participants Experiencing PD or Death in the First-Line Subpopulation|The criteria for PD are identified in previous outcome measure(s). The percentage of participants experiencing PD or death was calculated as the number of participants with event divided by the number of participants analyzed, multiplied by 100.|End of Cycles 3 and 6 (both treatment arms), end of Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks as confirmation of response, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years)|ITT Population (First-Line Subpopulation)||percentage of participants|||Number
810924|NCT01056523|Primary|Recommended Phase II Dose (RP2D) of Ribavirin When Given in Combination With Low-dose Ara-C|This 3+3 designed aimed to determine recommended phase II dose (RP2D) based on pharmacokinetics (PK) and maximum tolerated dose (MTD). For the dose to be selected, a target steady state level of ribavirin 20 uM was needed for all patients and no more than 1 of 6 patients could have had dose limiting toxicity at that dose.|56 days|||mg|||Number
810925|NCT01056601|Secondary|Duration of Response|Duration of response is calculated as (Date of First Disease Progression or Death as a Result of any Cause whichever Comes First - Date of First Objective Status Assessment of Confirmed Complete or Partial Response as defined by RECIST criteria).|Up to 1 Year|||Weeks|||Number
810915|NCT01056510|Secondary|Percentage of Participants by Disease Response Category in the First-Line Subpopulation|The criteria for CR, CRi, PR, and nPR are identified in previous outcome measure(s). PD was defined by at least one of the following: the presence of lymphadenopathy; an increase in the previously noted enlargement of the liver or spleen by >/= 50% or the de novo appearance of hepatomegaly or splenomegaly; an increase in the number of blood lymphocytes by >/= 50% with >/= 5000 B-cells per microliter (B-cells/mcL); transformation to a more aggressive histology; or occurrence of cytopenia attributable to CLL. Participants not achieving a CR or PR, and who did not exhibit PD, were considered to have stable disease (SD). The percentage of participants achieving each level of response was calculated as the number of participants meeting the above criteria divided by the number of participants analyzed. The rows below are labeled first by the level of response at the end of 6 cycles (C6), then by level of response at the confirmation assessment.|After 6 treatment cycles and at the confirmation of response assessment at least 12 weeks later (up to 36 weeks)|ITT Population (First-Line Subpopulation)||percentage of participants|||Number
810916|NCT01056510|Secondary|Percentage of Participants Achieving a Best Overall Response of CR, CR With Incomplete Marrow Recovery (CRi), Partial Response (PR), or Nodular PR (nPR) in the First-Line Subpopulation|The criteria for CR are identified in previous outcome measure(s). Those fulfilling CR criteria but who have persistent anemia, thrombocytopenia, or neutropenia were considered CRi. The definition of PR required that the following be documented for minimum 2 months: >/= 50% decrease in peripheral blood lymphocytes from Baseline; reduction in lymphadenopathy; >/= 50% reduction in spleen or liver enlargement; and CBC with one of the following without need for transfusion or exogenous growth factors: polymorphonuclear leukocytes >/= 1.5 times 10^9 cells/L, platelets > 100 times 10^9 cells/L or >/= 50% improvement from Baseline, or hemoglobin > 11.0 g/dL or >/= 50% improvement from Baseline. Participants with lymphoid nodules who otherwise met CR criteria were considered nPR. The percentage of participants achieving each level of response was calculated as the number of participants meeting the above criteria divided by the number of participants analyzed, multiplied by 100.|After 3 and 6 treatment cycles and from Baseline to the end-of-treatment (EOT) visit, completed within 10 days before cutoff for data collection|ITT Population (First-Line Subpopulation)||percentage of participants||95% Confidence Interval|Number
810917|NCT01056510|Secondary|Percentage of Participants Achieving Confirmed CR According to IWCLL 2008 Guidelines in the Second-Line Subpopulation After 6 Cycles of Therapy|The definition of confirmed CR required all of the following criteria as assessed at least 2 months after completion of therapy: peripheral blood lymphocytes < 4 times 10^9 cells/L; absence of significant lymphadenopathy, hepatomegaly, or splenomegaly due to CLL involvement; absence of constitutional symptoms; normal CBC without need for transfusion or exogenous growth factors, as exhibited by neutrophils >/= 1.5 times 10^9 cells/L, platelets > 100 times 10^9 cells/L, and hemoglobin > 11.0 g/dL; normocellular BM aspirate with < 30% lymphocytes; absence of lymphoid nodules; and BM biopsy without CLL activity. The percentage of participants achieving confirmed CR was calculated as the number of participants meeting the above criteria divided by the number of participants analyzed, multiplied by 100.|At least 2 months after completion of therapy (up to 32 weeks)|ITT Population (Second-Line Subpopulation): A subset of participants requiring a second-line regimen for CLL.||percentage of participants|||Number
810918|NCT01056510|Secondary|Percentage of Participants Achieving Confirmed CR According to IWCLL 2008 Guidelines in the Pooled Population After 6 Cycles of Therapy|The definition of confirmed CR required all of the following criteria as assessed at least 2 months after completion of therapy: peripheral blood lymphocytes < 4 times 10^9 cells/L; absence of significant lymphadenopathy, hepatomegaly, or splenomegaly due to CLL involvement; absence of constitutional symptoms; normal CBC without need for transfusion or exogenous growth factors, as exhibited by neutrophils >/= 1.5 times 10^9 cells/L, platelets > 100 times 10^9 cells/L, and hemoglobin > 11.0 g/dL; normocellular BM aspirate with < 30% lymphocytes; absence of lymphoid nodules; and BM biopsy without CLL activity. The percentage of participants achieving confirmed CR was calculated as the number of participants meeting the above criteria divided by the number of participants analyzed, multiplied by 100.|At least 2 months after completion of therapy (up to 32 weeks)|ITT Population||percentage of participants|||Number
810919|NCT01056510|Primary|Percentage of Participants Achieving Confirmed Complete Response (CR) According to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 Guidelines in the First-Line Subpopulation After 6 Cycles of Therapy|The definition of confirmed CR required all of the following criteria as assessed at least 2 months after completion of therapy: peripheral blood lymphocytes less than (<) 4 times 10^9 cells per liter (cells/L); absence of significant lymphadenopathy, hepatomegaly, or splenomegaly due to chronic lymphocytic leukemia (CLL) involvement; absence of constitutional symptoms; normal complete blood count (CBC) without need for transfusion or exogenous growth factors, as exhibited by neutrophils at least (>/=) 1.5 times 10^9 cells/L, platelets greater than (>) 100 times 10^9 cells/L, and hemoglobin > 11.0 grams per deciliter (g/dL); normocellular bone marrow (BM) aspirate with < 30 percent (%) lymphocytes; absence of lymphoid nodules; and BM biopsy without CLL activity. The percentage of participants achieving confirmed CR was calculated as the number of participants meeting the above criteria divided by the number of participants analyzed, multiplied by 100.|At least 2 months after completion of therapy (up to 32 weeks)|ITT Population (First-Line Subpopulation): A subset of participants requiring a first-line regimen for CLL.||percentage of participants|||Number
810920|NCT01056523|Secondary|Blast Response|Blast response was defined as a greater than 50% decrease in bone marrow blast count and 2 log reduction in peripheral blood blast count, sustained for at least 28 days.|2-3 years|Only patients treated for 28 days or more were evaluable for response.||Participants|||Count of Participants
810921|NCT01056523|Secondary|Partial Response|Partial response was defined as 5 to 25% blasts in the bone marrow and Hgb >100g/L, platelets >100,000/ul and neutrophils >1000/ul.|2-3 years|Only patients treated for 28 days or more were assessed for response.||Participants|||Count of Participants
810922|NCT01056523|Secondary|Complete Response Rate|Defined as <5% blasts in the bone marrow and a hgb 100 g/L, platelets 100,000/uL, neutrophils 1000/uL.|2-3 years|Only patients treated for at least 28 days were evaluable for response.||Participants|||Count of Participants
810958|NCT01056718|Primary|Resting Systolic BP||10 Weeks|||mm Hg||Standard Deviation|Mean
810959|NCT01056822|Secondary|Dose of the Study Medicinal Product Mycophenolate Mofetil (MMF)|Safety population per visit and per treatment group (missings not included)|at 12 months from baseline|The safety population included all randomised patients who gave signed informed consent and received at least one dose of the study medicinal product.||mg|Participants|Standard Deviation|Mean
810926|NCT01056601|Secondary|Number of Participants by Tumor Response|Number of patients whose tumor has responded to study therapy is determined using Response Evaluation Criteria In Solid Tumors. Progressive Disease (PD) is assessed if the sum of the diameters has increased by ≥ 20% and ≥ 5 mm from nadir (including baseline if it is the smallest sum). Objective response is measured by tumor reduction as defined in the RECIST criteria. Tumor shrinkage must be at least 30% to qualify as an objective response.|Up to 1 Year|||Participants|||Number
810927|NCT01056601|Primary|Progression-Free Survival|Median number of months before disease progressed in patient on gemcitabine when treated with the combination of panobinostat and bortezomib. Progression free survival is measured from randomization until the subject has documented disease progression by an objective measure. Subjects must be alive with no more than 20% increase in tumor size to qualify for progression free survival. Changes in tumor size are defined by RECIST criteria.|Up to 1 Year|||Months||95% Confidence Interval|Median
810928|NCT01056640|Primary|Mean # Participants Who Had Hospitalizations or ED Visits Compared to Usual Care in a High Risk Group of Adults ≥ 60 Years of Age With Mixed Chronic Disease.||12 months|This study utilized an intent-to-treat method. Everyone randomized to study was included in the analysis||hospitalizations||Standard Deviation|Mean
810929|NCT01056653|Secondary|Perceptions of Parenting an Infant - What Being the Parent of a Baby Is Like (WPL-R) Scale|25-item self-report measure composed of 3 subscales: Evaluation (11 items), Centrality (8 items), and Life Change (6 items). Each item is rated on a 9-point scale and subscale scores are obtained by averaging the scores of all items on a subscale; the range for all subscales is therefore 1 - 9. Higher scores reflect having more of the attribute being measured.|When the infant was 8 months old, adjusting for prematurity|Goup A Teal n = 45 due to missing data||Scores on a scale||Standard Deviation|Mean
810930|NCT01056653|Secondary|Parenting Stress - Parenting Stress Index - Third Edition (PSI-3)|"A 120-item self-report questionnaire of parenting stress with two domains. The Parent Domain (51 items) measures stress related to parental functioning, the Child Domain (50 items) measures child qualities and characteristics that contribute to stress in the parent-child system. The PSI-3 contains an additional Life Stress scale (19 items) which was not used in the study.
The range of possible scores in the Parent Domain is 50 - 250 and in the Child Domain is 51 - 255. In both domains, higher scores indicate more stress."|When the infant was 8 months old, adjusting for prematurity|Group A Teal n = 44 due to missing data||Scores on a scale||Standard Deviation|Mean
810931|NCT01056653|Primary|Parent Child Interaction Teaching Scale (PCITS)|"Assesses parent-infant interaction skills. Used for children from birth to 3 years of age. It is an observational measure of the presence of behaviours in parent-infant interactions.
The Parent Total (50 items) is the sum of 4 subscales: Sensitivity to Cues (11 items), Response to Distress (11 items), Social-Emotional Growth Fostering (11 items), and Cognitive Growth Fostering (17 items). Higher scores on all subscales and higher total scores reflect more optimal parent-infant interactions.
Possible ranges of scores are as follows: Parent Total (0 - 50), Sensitivity to Cues (0 - 11), Response to Distress (0 - 11), Social-Emotional Growth Fostering (0 - 11), and Cognitive Growth Fostering (0 - 17)"|When the infant was 8 months old, adjusting for prematurity|||Scores on a scale||Standard Deviation|Mean
810932|NCT01056718|Secondary|Quality of Life|"Quality of life was assessed by a visual analogue scale before and after 10 weeks of nebivolol. The subjects self reported assessment of his/her overall health was recorded on a vertical visual analogue scale where 100 is the best imaginable health state and 0 is the worst imaginable health state."|10 Weeks|||units on a scale||Standard Deviation|Mean
810933|NCT01056718|Secondary|Pulmonary Vein Peak Diastolic Velocity||10 Week|||cm/s||Standard Deviation|Mean
810934|NCT01056718|Secondary|Pulmonary Vein Peak Systolic Velocity||10 Week|||cm/s||Standard Deviation|Mean
810935|NCT01056718|Secondary|E/e' Ratio||10 Week|||Ratio||Standard Deviation|Mean
810936|NCT01056718|Secondary|Mitral Valve Tissue Doppler Velocity (a')||10 Week|||cm/s||Standard Deviation|Mean
810937|NCT01056718|Secondary|Mitral Valve Tissue Doppler Velocity (e')||10 Week|||cm/s||Standard Deviation|Mean
810938|NCT01056718|Secondary|Mitral Valve Deceleration Time||10 Week|||ms||Standard Deviation|Mean
810939|NCT01056718|Secondary|Mitral Valve E/A Ratio|mitral valve doppler E velocity to A velocity|10 Week|||Ratio||Standard Deviation|Mean
810940|NCT01056718|Secondary|Mitral Valve Inflow (A) Velocity||10 Week|||cm/s||Standard Deviation|Mean
810941|NCT01056718|Secondary|Mitral Valve Inflow (E) Velocity||10 Week|||cm/s||Standard Deviation|Mean
810942|NCT01056718|Secondary|LV Mass||10 week|||grams||Standard Deviation|Mean
810943|NCT01056718|Secondary|LV End Systolic Diameter||10 week|||cm||Standard Deviation|Mean
810944|NCT01056718|Secondary|LV End Diastolic Diameter||10 week|||cm||Standard Deviation|Mean
810945|NCT01056718|Secondary|Stress Cardiac Output||10 week|||L per minute||Standard Deviation|Mean
810946|NCT01056718|Secondary|Resting Cardiac Output||10 week|||L per minute||Standard Deviation|Mean
810947|NCT01056718|Secondary|Stress Stroke Volume||10 week|||ml||Standard Deviation|Mean
810948|NCT01056718|Secondary|Resting Stroke Volume||10 weeks|||ml||Standard Deviation|Mean
810949|NCT01056718|Secondary|Stress EF||10 Week|||Percent of LV end diastolic volume||Standard Deviation|Mean
810950|NCT01056718|Secondary|Resting EF||10 Weeks|||Percent of LV end diastolic volume||Standard Deviation|Mean
810951|NCT01056718|Secondary|Stress Heart Rate||10 Week|||Beats per Minute||Standard Deviation|Mean
810952|NCT01056718|Secondary|Resting Heart Rate||10 Week|||Beats per Minute||Standard Deviation|Mean
810953|NCT01056718|Secondary|Peak Stress Diastolic BP||10 Week|||mm Hg||Standard Deviation|Mean
810954|NCT01056718|Secondary|Peak Stress Systolic BP||10 Week|||mm Hg||Standard Deviation|Mean
810955|NCT01056718|Secondary|Diastolic BP||10 Week|||mm Hg||Standard Deviation|Mean
810956|NCT01056718|Primary|Metabolic Equivalent (METS) Level|METs is a measure of exercise capacity. One MET is defined as 3.5 mL 02 uptake/kg per minute which is the resting oxygen uptake in a sitting position. The Bruce protocol consisted of successive 3 minute stages each of which requires the subject to walk at a faster speed and higher grade of incline. Each stage is assigned a MET level. The achieved exercise capacity in METs has been shown to be predictive in older adult population of survival with higher MET levels associated with improved survival.|10 Weeks|||METS||Standard Deviation|Mean
810957|NCT01056718|Primary|Exercise Duration||10 Weeks|||Seconds||Standard Deviation|Mean
810960|NCT01056822|Secondary|Dose of the Study Medicinal Product Mycophenolate Sodium (MPS)|Safety population per visit and per treatment group|at 12 months from baseline|The safety population included all randomised patients who gave signed informed consent and received at least one dose of the study medicinal product.||mg|Participants|Standard Deviation|Mean
810961|NCT01056822|Secondary|Duration of Exposure to the Study Medicinal Product, Mycophenolate Sodium Descriptive Statistics. Safety Population Per Treatment Group|Exposure to study drug (MPS). Data presented only for safety population on the study treatment arm (not applicable for MMF arm)|at 12 months from baseline|The safety population included all randomised patients who gave signed informed consent and received at least one dose of the study medicinal product.||days|Participants|Standard Deviation|Mean
810962|NCT01056822|Secondary|Change in SIGIT-QoL Score From Baseline to Visit 5 Stratified on the Basis of the Presence or Absence of SNP in the MRP2 Gene for the ITT Population|Sub-study primary endpoint. The SIGIT-QoL scale is a 17 items instrument, the score of each item ranges from 0 (always) to 4 (never). The scale score is obtained by adding the scores of the 17 items. Therefore, the total score ranges from 0 to 68 points. Higher score means, less impairment of Health Related QoL of the patient and vice versa, the lower the score, the greater severity of symptoms and worse perceived by the patient|at 12 months from baseline|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus). Missing not included||scores on a scale|Participants|Standard Deviation|Mean
810963|NCT01056822|Secondary|Change in SIGIT-QoL Score From Baseline to Visit 4 Stratified on the Basis of the Presence or Absence of SNP in the MRP2 Gene for the ITT Population|Sub-study primary endpoint. The SIGIT-QoL scale is a 17 items instrument, the score of each item ranges from 0 (always) to 4 (never). The scale score is obtained by adding the scores of the 17 items. Therefore, the total score ranges from 0 to 68 points. Higher score means, less impairment of Health Related QoL of the patient and vice versa, the lower the score, the greater severity of symptoms and worse perceived by the patient|at 12 months from baseline|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus). Missings not included||scores on a scale|Participants|Standard Deviation|Mean
810964|NCT01056822|Secondary|Change in SIGIT-QoL Score From Baseline to Visit 2 Stratified on the Basis of the Presence or Absence of SNP in the MRP2 Gene for the ITT Population|Sub-study primary endpoint. SIGIT-QoL scale is a 17 items instrument, the score of each item ranges from 0 (always) to 4 (never). The scale score is obtained by adding the scores of the 17 items. Therefore, the total score ranges from 0 to 68 points. Higher score means, less impairment of Health Related QoL of the patient and vice versa, the lower the score, the greater severity of symptoms and worse perceived by the patient|at 12 months from baseline|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus)||scores on a scale|Participants|Standard Deviation|Mean
810965|NCT01056822|Secondary|Change in SIGIT-QoL Score From Baseline to Visit 5 Stratified on the Basis of the Presence or Absence of SNP in the UGT1A9 Gene for the ITT Population|Sub-study primary endpoint. The SIGIT-QoL scale is a 17 items instrument, the score of each item ranges from 0 (always) to 4 (never). The scale score is obtained by adding the scores of the 17 items. Therefore, the total score ranges from 0 to 68 points. Higher score means, less impairment of Health Related QoL of the patient and vice versa, the lower the score, the greater severity of symptoms and worse perceived by the patient|at 12 months from baseline|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus)||scores on a scale|Participants|Standard Deviation|Mean
810966|NCT01056822|Secondary|Change in SIGIT-QoL Score From Baseline to Visit 4 Stratified on the Basis of the Presence or Absence of SNP in the UGT1A9 Gene for the ITT Population|Sub-study primary endpoint. The SIGIT-QoL scale is a 17 items instrument, the score of each item ranges from 0 (always) to 4 (never). The scale score is obtained by adding the scores of the 17 items. Therefore, the total score ranges from 0 to 68 points. Higher score means, less impairment of Health Related QoL of the patient and vice versa, the lower the score, the greater severity of symptoms and worse perceived by the patient|at 12 months from baseline|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus)||scores on a scale|Participants|Standard Deviation|Mean
810967|NCT01056822|Secondary|Change in SIGIT-QoL Score From Baseline to Visit 2 Stratified on the Basis of the Presence or Absence of SNP in the UGT1A9 Gene for the ITT Population|Sub-study primary endpoint. The SIGIT-QoL scale is a 17 items instrument, the score of each item ranges from 0 (always) to 4 (never). The scale score is obtained by adding the scores of the 17 items. Therefore, the total score ranges from 0 to 68 points. Higher score means, less impairment of Health Related QoL of the patient and vice versa, the lower the score, the greater severity of symptoms and worse perceived by the patient|at 12 months from baseline|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus)||scores on a scale|Participants|Standard Deviation|Mean
810989|NCT01057121|Secondary|Time to Death|Percentage of patients who died|Up to 30 days after completion of study treatment|Study participants who died on study.||percentage of participants who died|||Number
811074|NCT01051778|Primary|Live Birth Rate = (Number of Live Births / Total Number of Pregnancies)|Live birth occurs when a fetus (> 24 weeks ) , exits the maternal body and subsequently shows signs of life, such as voluntary movement, heartbeat, or pulsation of the umbilical cord.|pregnancy > 24weeks gestation|||Percentage of pregnancies|||Number
810968|NCT01056822|Secondary|Change in Gastrointestinal Symptom Rating Scale (GSRS) Score From Baseline to Visit 5 Stratified on the Basis of the Presence or Absence of Single-nucleotide Polymorphisms (SNPs) in the MRP2 Gene for the ITT Population|Sub-study primary endpoint. The GSRS is a 15-item instrument design to assess the symptoms associated to gastrointestinal disorders. It has 5 subscales (reflux, diarrhoea, constipation, abdominal pain and indigestion) with scores rating from 1 to 7 (with a higher score representing more gastrointestinal symptoms)|at 12 months from baseline|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus)||scores on a scale|Participants|Standard Deviation|Mean
810969|NCT01056822|Secondary|Change in Gastrointestinal Symptom Rating Scale (GSRS) Score From Baseline to Visit 4 Stratified on the Basis of the Presence or Absence of Single-nucleotide Polymorphisms (SNPs) in the MRP2 Gene for the ITT Population|Sub-study primary endpoint. The GSRS is a 15-item instrument design to assess the symptoms associated to gastrointestinal disorders. It has 5 subscales (reflux, diarrhoea, constipation, abdominal pain and indigestion) with scores rating from 1 to 7 (with a higher score representing more gastrointestinal symptoms)|at 12 months from baseline|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus)||scores on a scale|Participants|Standard Deviation|Mean
810970|NCT01056822|Secondary|Change in Gastrointestinal Symptom Rating Scale (GSRS) Score From Baseline to Visit 2 Stratified on the Basis of the Presence or Absence of Single-nucleotide Polymorphisms (SNPs) in the MRP2 Gene for the ITT Population|Sub-study primary endpoint. The GSRS is a 15-item instrument design to assess the symptoms associated to gastrointestinal disorders. It has 5 subscales (reflux, diarrhoea, constipation, abdominal pain and indigestion) with scores rating from 1 to 7 (with a higher score representing more gastrointestinal symptoms)|at 12 months from baseline|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus)||scores on a scale|Participants|Standard Deviation|Mean
810971|NCT01056822|Secondary|Change in Gastrointestinal Symptom Rating Scale (GSRS) Score From Baseline to Visit 5 Stratified on the Basis of the Presence or Absence of Single-nucleotide Polymorphisms (SNPs) in the UGT1A9 Gene for the ITT Population|Sub-study primary endpoint. The GSRS is a 15-item instrument design to assess the symptoms associated to gastrointestinal disorders. It has 5 subscales (reflux, diarrhoea, constipation, abdominal pain and indigestion) with scores rating from 1 to 7 (with a higher score representing more gastrointestinal symptoms)|at 12 months from baseline|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus). Missing not included||scores on a scale|Participants|Standard Deviation|Mean
810972|NCT01056822|Secondary|Change in Gastrointestinal Symptom Rating Scale (GSRS) Score From Baseline to Visit 4 Stratified on the Basis of the Presence or Absence of Single-nucleotide Polymorphisms (SNPs) in the UGT1A9 Gene for the ITT Population|Sub-study primary endpoint. The GSRS is a 15-item instrument design to assess the symptoms associated to gastrointestinal disorders. It has 5 subscales (reflux, diarrhoea, constipation, abdominal pain and indigestion) with scores rating from 1 to 7 (with a higher score representing more gastrointestinal symptoms)|at 12 months from baseline|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus)||scores on a scale|Participants|Standard Deviation|Mean
810973|NCT01056822|Secondary|Change in Gastrointestinal Symptom Rating Scale (GSRS) Score From Baseline to Visit 2 Stratified on the Basis of the Presence or Absence of Single-nucleotide Polymorphisms (SNPs) in the UGT1A9 Gene for the ITT Population|Sub-study primary endpoint. The GSRS is a 15-item instrument design to assess the symptoms associated to gastrointestinal disorders. It has 5 subscales (reflux, diarrhoea, constipation, abdominal pain and indigestion) with scores rating from 1 to 7 (with a higher score representing more gastrointestinal symptoms)|at 12 months from baseline|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus)||scores on a scale|Participants|Standard Deviation|Mean
810974|NCT01056822|Secondary|Health-related Quality of Life (HRQoL): Impact of Gastrointestinal Symptoms on Quality Of Life (SIGIT)-QoL Questionnaire. Total Score.|The SIGIT-QoL scale is a 17 items instrument, the score of each item ranges from 0 (always) to 4 (never). The scale score is obtained by adding the scores of the 17 items. Therefore, the total score ranges from 0 to 68 points. Higher score means, less impairment of Health Related QoL of the patient and vice versa, the lower the score, the greater severity of symptoms and worse perceived by the patient|Visit 1 (30 days +/-4), visit 2 (90 days +/- 15), visit 3 (150 days +/- 15), visit 4 (210 days +/- 15), visit 5 (365 days +/- 15)|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus). Missings not included||scores on a scale|Participants|Standard Deviation|Mean
811013|NCT01057589|Secondary|Overall Survival (OS)|OS defined as the time from the date of first dose of study drug to the date to death from any cause.|Baseline to date of death up to 18.7 months|PQ Population: all randomized and treated participants||months||95% Confidence Interval|Median
811075|NCT01051817|Secondary|Raw Number of Cumulative New Gd-T2 Lesions|The summary of raw number of cumulative new Gadolinium-enhanced T2 lesions observed on brain MRI scans performed every 4th week from WK 4 to WK 28. The endpoint is week 24.|MRI brain scans performed every 4 weeks at week 4, 8, 12, 16, 20, 24 and 28 (EOS).|full analysis Set||Cumulative new Gd-T2 lesions||Full Range|Mean
810975|NCT01056822|Secondary|Gastrointestinal Symptom Rating Scale (GSRS) Subscale Score|The GSRS is a 15-item instrument design to assess the symptoms associated to gastrointestinal disorders. It has 5 subscales (reflux, diarrhoea, constipation, abdominal pain and indigestion) with scores rating from 1 to 7 (with a higher score representing more gastrointestinal symptoms)|Visit 1 (30 days +/-4), visit 2 (90 days +/- 15), visit 3 (150 days +/- 15), visit 4 (210 days +/- 15), visit 5 (365 days +/- 15)|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus). Missings not included||scores on a scale|Participants|Standard Deviation|Mean
810976|NCT01056822|Secondary|Gastrointestinal Symptom Rating Scale (GSRS) Item Score|The GSRS is a 15-item instrument design to assess the symptoms associated to gastrointestinal disorders. It has 5 subscales (reflux, diarrhoea, constipation, abdominal pain and indigestion) with scores rating from 1 to 7 (with a higher score representing more gastrointestinal symptoms)|Visit 1 (30 days +/-4), visit 2 (90 days +/- 15), visit 3 (150 days +/- 15), visit 4 (210 days +/- 15), visit 5 (365 days +/- 15)|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus). Missings not included||scores on a scale|Participants|Standard Deviation|Mean
810977|NCT01056822|Secondary|Glomerular Filtration Rate (GFR) Using Abbreviated MDRD|Calculated GFR (MDRD formula): GFR [mL/min/1.73m2] = 186.3*(C-1.154)*(A-0.203)*G*R where C is the serum concentration of creatinine [mg/dL], A is age [years], G=0.742 when gender is female, otherwise G=1, R=1.21 when race is black, otherwise R=1|Visit 1 (30 days +/-4), visit 2 (90 days +/- 15), visit 3 (150 days +/- 15), visit 4 (210 days +/- 15), visit 5 (365 days +/- 15)|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus).||mL/min/1.73m^2||Standard Deviation|Mean
810978|NCT01056822|Secondary|Change in Renal Function Measured Using Cockcroft-Gault Creatinine Clearance (CrCl)||Visit 1 (30 days +/-4), visit 2 (90 days +/- 15), visit 3 (150 days +/- 15), visit 4 (210 days +/- 15), visit 5 (365 days +/- 15)|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus).||ml/min|Participants|Standard Deviation|Mean
810979|NCT01056822|Primary|Mean Mycophenolic Acid (MPA) Doses at the End of the Study (Final Visit) Compared to Baseline Dose.||at 12 months from baseline|Per protocol (PP) population included all subjects from the ITT population who received medication throughout the study and did not have major protocol deviations and who participated in the study for a minimum of 210 days +/- 15 days||mg/day||Standard Deviation|Mean
810980|NCT01056822|Primary|Participants With Reduction in Tacrolimus or Tacrolimus Extended Release Levels at the End of the Study (Final Visit) Compared to Baseline Dose.||at 12 months from baseline|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus).||Participants|||Number
810981|NCT01056822|Primary|Number of Participants That Achieved One Dose Step Higher With Mycophenolic Acid (MPA) or Mycophenolate Mofetil (MMF), According to the Treatment Group Assigned at the End of the Study (Final Visit) Compared to Baseline Dose||at 12 months from baseline|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus).||study participants|||Number
810982|NCT01056822|Primary|Number of Participants Achieving at Least Two Mycophenolic Acid (MPA) Dose Steps Higher and Reducing Tacrolimus Dose at the End of the Study||at 12 months from baseline|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus).||number of participants|||Number
810983|NCT01056913|Secondary|Clinical Relevant Stenosis||six months||||||
810984|NCT01056913|Primary|Anastomotic Leakage||4-8 weeks|||participants|||Number
810985|NCT01057017|Primary|Number of Patients With Toxicity to Combination of Panitumumab and Bevacizumab|To determine the safety of every 3 week panitumumab and bevacizumab as maintenance therapy for patients with metastatic colorectal cancer. Use of CTCAE version 3|every 3 weeks until patient comes off study (progressive disease), for up to 2 years|||participants|||Number
810986|NCT01057121|Other Pre-specified|Relationship Between Clinical Response and Quantitative Measures of Kaposi's Sarcoma-associated Herpesvirus (KSHV)/HHV-8 and HIV Viral Load|Spearman rank correlation analysis will be used to evaluate the relationship between the qualification of baseline KSHV/HHV-8, HIV viral load and time to progression, and response duration.|Up to 30 days after completion of study treatment|The KSHV (HHV-8) assays were run, but the results were unreliable.|||||
810987|NCT01057121|Secondary|Time to Response|"time from enrollment to first response (complete or partial) as defined below: Complete response is defined as the absence of any detectable residual disease, including tumor-associated edema, persisting for at least 4 weeks.
Partial response is defined as no new lesions (skin or oral), or new visceral sites of involvement (or the appearance or worsening of tumor-associated edema or effusions), and a 50% or greater decrease in the number of all previously existing lesions lasting for at least 4 weeks, or complete flattening of at least 50% of all previously raised lesions, or a 50% or greater decrease in the sum of the products of the largest perpendicular diameters of the marker lesions."|Up to 30 days after completion of study treatment|Participants who had a complete or partial responses||weeks||Full Range|Median
810988|NCT01057121|Secondary|Time to Relapse|Percentage of participants who relapsed|Up to 30 days after completion of study treatment|Patients who relapsed|||||
810990|NCT01057121|Primary|Tumor Response Rate|"Percentage of patients who achieve a partial or complete response Complete response was defined as the absence of any detectable residual disease, including tumor-associated edema, that persisted for at least 4 weeks.
Partial response was defined as no new lesions (skin or oral), or new visceral sites of involvement (or the appearance or worsening of tumor-associated edema or effusions), and a 50% or greater decrease in the number of all previously existing lesions that lasted for at least 4 weeks, or complete flattening of at least 50% of all previously raised lesions, or a 50% or greater decrease in the sum of the products of the largest perpendicular diameters of the marker lesions."|Up to 30 days after completion of study treatment|Patients who were evaluable for response. To be evaluable for response, the patient had to complete at least one cycle of treatment.||percent of participants who responded||95% Confidence Interval|Number
810991|NCT01057121|Primary|Maximum Tolerated Dose of Lenalidomide Defined as the Dose Level at Which 0/6 or 1/6 Subjects Experience Dose Limiting Toxicity (DLT) With the Next Higher Dose Having at Least 2/3 or 2/6 Subjects Encountering DLT (Phase I)|Maximum tolerated dose (MTD) of lenalidomide defined as the dose level at which 0/6 or 1/6 subjects experience dose limiting toxicity (DLT) with the next higher dose having at least 2/3 or 2/6 subjects encountering DLT (Phase I). Toxicities will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Using a 3+3 design, the MTD is defined as the level at which 0/6 or 1/6 patients experiences at dose-limiting toxicity in the first cycle.|28 days|Only patients in the phase I portion of the study were evaluated for this outcome measure.||mg per day of lenalidomide|||Number
810992|NCT01057225|Secondary|Overall Survival (24 Month)|24 Month Overall survival is defined as the proportion of patients to still be alive after 24 months.|From baseline to death|All of the 64 participants that were eligible and began treatment were evaluated.||percentage of patients||95% Confidence Interval|Number
810993|NCT01057225|Secondary|Overall Survival (12 Month)|12 Month Overall survival is defined as the proportion of patients to still be alive after 12 months.|From baseline to death|All of the 64 participants that were eligible and began treatment were evaluated.||percentage of patients||95% Confidence Interval|Number
810994|NCT01057225|Secondary|Progession Free Survival (24 Month)|Progression-free survival time is defined as the time from registration to the earliest date of documentation of disease progression. If a patient dies without a documentation of disease progression the patient will be considered to have had disease progression at the time of their death. If the patient is declared to be a major treatment violation, the patient will be censored on the date the treatment violation was declared to have occurred. In the case of a patient starting treatment and then never returning for any evaluations, the patient will be censored for progression 1 day post-registration. This is reported as the percentage of patients alive and progression free at the 24 month mark.|24 months|All of the 64 participants that were eligible and began treatment were evaluated.||percentage of participants at 24 months||95% Confidence Interval|Number
810995|NCT01057225|Secondary|Progression Free Survival (12 Month)|Progression-free survival time is defined as the time from registration to the earliest date of documentation of disease progression. If a patient dies without a documentation of disease progression the patient will be considered to have had disease progression at the time of their death. If the patient is declared to be a major treatment violation, the patient will be censored on the date the treatment violation was declared to have occurred. In the case of a patient starting treatment and then never returning for any evaluations, the patient will be censored for progression 1 day post-registration. This is reported as the percentage of patients alive and progression free at the 12 month mark.|12 months|All of the 64 participants that were eligible and began treatment were evaluated.||percentage of participants at 12 months||95% Confidence Interval|Number
810996|NCT01057225|Secondary|Survival Time (Phase II)|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier|From baseline to death|||months||95% Confidence Interval|Median
810997|NCT01057225|Secondary|Complete Response (Phase II)|In patients continuing beyond 4 cycles the ability to induce complete response will be evaluated at completion of planned therapy.|Following the first 4 courses of treatment|||participants|||Number
810998|NCT01057225|Secondary|Stem Cell Collection and Engraftment (Phase II)|For patients going on to stem cell collection, the total number of CD34 positive cells collected per collection, days to platelets over 20,000 without transfusion and ANC over 1000 will be recorded. If a patient fails to collect adequate stem cells for transplant, this will be recorded as such. The number of patients with successful stem cell mobilization are reported.|Following the first 4 courses of treatment|Of the 64 patients that began protocol treatment, stem cell harvesting was attempted on 42 patients.||participants|||Number
810999|NCT01057225|Secondary|Time to Treatment Failure|The time from the date of registration to the date at which the patient is removed from treatment due to progression, adverse events, or refusal. If the patient is considered to be a major treatment violation or is taken off study as a non-protocol failure, the patient will be censored on the date they were removed from treatment. The distribution of time to treatment failure will be estimated using the method of Kaplan-Meier|From baseline to end of active treatment|All enrolled patients who began treatment were evaluated for safety and response.||months||95% Confidence Interval|Number
811000|NCT01057225|Secondary|Progression-free Survival (Phase II)|"PFS was defined as the time from registration to progression or death due to any cause. Progression was defined as any one or more of the following:
• Increase of 25% from lowest confirmed response in: Serum M-component (absolute increase must be ≥ 0.5 g/dl)c Urine M-component (absolute increase must be ≥ 200 mg/24 hour) If at on study, only the measurable non-bone marrow parameter was FLC, the difference between involved and uninvolved FLC levels (absolute increase must be >10 mg/dl) Bone marrow plasma cell percentage (absolute % must be 10%)d Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas
• Development of hypercalcemia (corrected serum calcium >11.5 mg/dl) that can be attributed solely to the plasma cell proliferative disorder"|From baseline to progression or death up to 3 years|All of the 64 participants that were eligible and began treatment were evaluated.||months||95% Confidence Interval|Number
811076|NCT01051817|Secondary|Raw Number of Cumulative New Gd-T1 Lesions|The summary of raw number of cumulative new Gadolinium-enhanced T1 lesions observed on brain MRI scans performed every 4th week from WK 4 to WK 28. The end-point is week 24.|MRI brain scans performed every 4 weeks at week 4, 8, 12, 16, 20, 24 and 28 (EOS).|Full analysis set||cumulative new Gd-T1 lesions||Full Range|Mean
811001|NCT01057225|Primary|Percentage of Patients Who Have at Least a Confirmed Very Good Partial Response (Phase II)|"The proportion of patients who have at least a confirmed very good partial response will be calculated by taking the number of patients with a very good partial response or a complete response divided by the total number of patients.
A complete response is defined as:
Negative immunofixation of the serum and urine
If at on study, only the measurable non-bone marrow parameter was FLC, normalization of FLC ratio
< 5% plasma cells in bone marrow
Disappearance of any soft tissue plasmacytomas
A very good partial response is defined as:
Serum and urine M-component detectable by immunofixation but not on electrophoresis or
If at on study, serum measurable, ≥ 90% or greater reduction in serum Mcomponent
Urine M-component <100 mg per 24 hour"|Following the first 4 cycles of treatment (28 day cycles)|All enrolled patients who began treatment were evaluated for safety and response.||percentage of participants|||Number
811002|NCT01057225|Primary|Maximum Tolerated Dose (Phase I)|"To establish the maximum tolerated dose of carfilzomib given in combination with oral cyclophosphamide and thalidomide and dexamethasone.
For this protocol, dose-limiting toxicity (DLT) will be defined as an adverse event attributed (definitely, probably, possibly) in the first or second cycle for patients enrolled to Dose Levels -1 and 0 and in the first cycle only for patients enrolled to Dose Levels 1 and 2.
We are reporting the number of DLTs"|From baseline to end of active treatment, up to 12 28-day cycles.|All patients registered to a dose escalation Phase I group were analyzed for this endpoint.||participants|||Number
811003|NCT01057251|Primary|Change From Baseline in Mean Seated Diastolic Blood Pressure After 6 Weeks of Nebivolol Monotherapy|Office blood pressure measured at trough by automatic oscillometric device.|Change from Baseline (Week 0) to Visit 4 (Week 6)|||mm Hg||Standard Deviation|Mean
811004|NCT01057251|Primary|Change From Baseline in Mean Seated Systolic Blood Pressure After 6 Weeks of Nebivolol Monotherapy|Office blood pressure measured at trough by automatic oscillometric device.|Change from Baseline Visit 1 (week 0) to Visit 4 (Week 6)|||mm Hg||Standard Deviation|Mean
811005|NCT01057277|Primary|Response||1 year|||participants|||Number
811006|NCT01057394|Primary|Rate of Permanent Pulmonary Vein Isolation of EAS-AC Compared to EAM Guided Radiofrequency Ablation|Number of initially isolated pulmonary veins that remain isolated at a 3 month remapping. The unit of measure is treated pulmonary veins (PVs).|3 Months|Of the 21 enrolled participants, 19 were treated participants and 17 of the 19 came back for the 3 month PV remapping and were thus evaluable for effectiveness. This resulted in 46/59 (78%) pulmonary veins being assessed for chronic isolation.||isolated pulmonary veins|||Number
811007|NCT01057433|Secondary|Adverse Events||24 Days||||||
811008|NCT01057433|Primary|Area Under the Curve From Time 0 to Tau (AUC 0-τ)|Area under the curve from start to elimination.|12 hours|||ng•h/mL||Standard Deviation|Mean
811009|NCT01057589|Secondary|Change From Baseline in Performance Status Scale for Head and Neck Cancer Patients (PSS-HNC)|PSS-HNC is a clinician-rated instrument designed to measure speaking and eating disabilities of participants with head and neck cancer and consists of 3 subscales: Normalcy of Diet (NOD) subscale measures the ability of the participants to eat a normal diet, scale ranged from 0 (non-oral feeding) to 100 (unrestricted diet); Understandability of Speech (UOS)subscale measured the degree a clinician was able to understand the participant’s speech, subscale ranged from 0 (never understandable) to 100 (always understandable); Eating in Public (EIP) subscale, rating based on clinician question to the participant to report who he/she eats with and in what setting, subscale ranged from 0 (always eats alone) to 100 (no restriction of place, food, or companion). Change from baseline: negative value represents a decrease in function and a positive value represents an increase in function.|Baseline, Triplet Combination Therapy Cycles 2, 4, 6 (cycle = 21 days) and optional Maintenance Therapy Cycles 1, 3, 5 and 7 (cycle = 21 days)|PQ Population: all randomized and treated participants with evaluable data at respective timepoint.||units on a scale||Standard Deviation|Mean
811010|NCT01057589|Secondary|Change From Baseline in Participant Reported EQ-5D Utility Score at End of Triplet Combination Therapy and End of Maintenance Therapy|EQ-5D Index is derived by converting the Descriptive System (participant is required to rate health by checking 1 [no limitation], 2 [some limitation] or 3 [severe or complete limitation] in 5 dimensions [mobility, self-care, usual activities, pain/comfort and anxiety/depression]) to a single summary index. A utility value assigned to each individual's health state based on the absence or presence of moderate or severe problems in the 5 dimensions. A regression equation defines a utility value for these health states. The possible values for health utility ranged from -0.59 (severe problems in all 5 dimensions) to 1 (no problem in all dimensions) on a scale where 0 represents death and 1 represents the best possible health state. Possible change values range from -1.59 (no problems at baseline to severe problems at visit) to 1.59 (severe problems at baseline to no problems at visit).|Baseline, End of Triplet Combination Therapy (up to 6 cycles [4.2 months]) , End of Maintenance Therapy (up to 18.7 months)|PQ Population: all randomized and treated participants with EQ-5D data at respective timepoint.||units on a scale||Standard Deviation|Mean
811011|NCT01057589|Secondary|Change From Baseline in Participant Reported European-Quality of Life 5 Dimension Instrument (EQ-5D) Visual Analog Scale (VAS) at End of Triplet Combination Therapy and End of Maintenance Therapy|Vertical VAS - a 20 millimeter (mm), fractionated scale in the form of a thermometer with endpoints of 0 (worst imaginable health state) and 100 (best imaginable health state). Participants used the EQ-5D VAS scale to rate their overall health on the day the questionnaire was administered. Possible change values range from -100 (best imaginable health at baseline changed to worst possible health at visit) to 100 (worst possible health at baseline changed to best possible health at visit).|Baseline, End of Triplet Combination Therapy (up to Cycle 6 [4.2 months]), End of Maintenance Therapy (up to 18.7 months)|PQ Population: all randomized and treated participants with evaluable data for each category||units on a scale||Standard Deviation|Mean
811012|NCT01057589|Secondary|Percent of Participants With a Partial Response (PR) or a Complete Response (CR)|CR and PR based on RECIST Guidelines: CR is defined as the disappearance of all tumor lesions; PR is defined as at least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LDs or the complete disappearance of target lesions, with persistence (but not worsening) of one or more nontarget lesions and the appearance of no new lesions. PD is defined as at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Date of first response to PD (up to 18.7 months)|PQ Population: all randomized and treated participants with evaluable data; 6 participant's results were unknown.||percentage of participants||95% Confidence Interval|Number
811014|NCT01057589|Primary|Progression Free Survival (PFS)|PFS based on Response Evaluation Criteria in Solid Tumors (RECIST) Guidelines defined as the time from the date of first dose of study drug to first documented objective progressive disease (PD) or death from any cause. PD is defined as at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Baseline to date of PD or death up to 18.7 months|Protocol Qualified (PQ) Population: all randomized and treated participants||months||95% Confidence Interval|Median
811015|NCT01057693|Secondary|Patient Global Evaluation of Study Medication (GESM) (Double-Blind Phase)|GESM: single-item, self-administered treatment satisfaction questionnaire. Participants answered “how would you rate the study medication you received for pain?” on a 7-point scale ranging from 1 (very satisfied) to 7 (very dissatisfied). Number of participants in each category are reported.|Week 19|"FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||participants|||Number
811016|NCT01057693|Secondary|Patient Global Evaluation of Study Medication (GESM) (Single-Blind Phase)|GESM: single-item, self-administered treatment satisfaction questionnaire. Participants answered “how would you rate the study medication you received for pain?” on a 7-point scale ranging from 1 (very satisfied) to 7 (very dissatisfied). Number of participants in each category are reported.|Week 6|"SBAS included all participants who were enrolled into the single-blind treatment phase and received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||participants|||Number
811017|NCT01057693|Secondary|Hospital Anxiety and Depression Scale (HADS) (Double-Blind Phase)|HADS: self-administered questionnaire, consists of 2 sub-scales; measuring anxiety (HADS-A), and depression (HADS-D). Each sub-scale consists of 7 items on which participants responded as to how each item applies to them on a 4-point scale ranging from 0 (no anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range for each sub-scale = 0 to 21, where higher score indicates more severe anxiety or depression.|Week 19|FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Missing data were imputed using LOCF. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
811018|NCT01057693|Secondary|Hospital Anxiety and Depression Scale (HADS) (Single-Blind Phase)|HADS: self-administered questionnaire, consists of 2 sub-scales; measuring anxiety (HADS-A), and depression (HADS-D). Each sub-scale consists of 7 items on which participants responded as to how each item applies to them on a 4-point scale ranging from 0 (no anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range for each sub-scale = 0 to 21, where higher score indicates more severe anxiety or depression.|SB Baseline, Week 6|SBAS included all participants who were enrolled into the single-blind treatment phase and received at least 1 dose of study treatment. Here “N” (number of participants) signifies participants who were evaluable for this measure and “n” signifies participants who were evaluable for specified time point.||units on a scale||Standard Deviation|Mean
811019|NCT01057693|Secondary|Brief Pain Inventory-Short Form (BPI-sf) (Double-Blind Phase)|BPI-sf: self-administered questionnaire developed to assess severity, impact of pain on daily functions, consisted of 5 questions. Questions 1-4 measured the severity of pain based on pain experienced over the past 24-hours on an 11-point scale ranged from 0 (no pain) to10 (worst possible pain). Question 5: 7 item subsets that measured level of interference of pain on daily functions on an 11-point scale ranged from 0 (does not interfere) to 10 (completely interferes).|Week 19|FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Missing data were imputed using LOCF. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
811020|NCT01057693|Secondary|Brief Pain Inventory-Short Form (BPI-sf) (Single-Blind Phase)|BPI-sf: self-administered questionnaire developed to assess severity, impact of pain on daily functions, consisted of 5 questions. Questions 1-4 measured the severity of pain based on pain experienced over the past 24-hours on an 11-point scale ranged from 0 (no pain) to10 (worst possible pain). Question 5: 7 item subsets that measured level of interference of pain on daily functions on an 11-point scale ranged from 0 (does not interfere) to 10 (completely interferes).|SB Baseline, Week 6|SBAS included all participants who were enrolled into the single-blind treatment phase and received at least 1 dose of study treatment. Here “n” signifies participants who were evaluable for specified time-point.||units on a scale||Standard Deviation|Mean
811021|NCT01057693|Secondary|Pain Visual Analog Scale (VAS) (Double-Blind Phase)|Participants rated their pain on a 100 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 mm = no pain to 100 mm = worst possible pain.|Week 19|FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Missing data were imputed using LOCF. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||mm||Standard Deviation|Mean
811022|NCT01057693|Secondary|Pain Visual Analog Scale (VAS) (Single-Blind Phase)|Participants rated their pain on a 100 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 mm = no pain to 100 mm = worst possible pain.|SB Baseline, Week 6|SBAS included all participants who were enrolled into the single-blind treatment phase and received at least 1 dose of study treatment. Here “n” signifies participants who were evaluable for specified time-point.||mm||Standard Deviation|Mean
811023|NCT01057693|Secondary|Quality of Life Questionnaire– Diabetic Neuropathy (QOL-DN) (Double-Blind Phase)|QOL-DN: 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy. Consists of 5 domains: Physical functioning(Ph Fn)/large fiber (sum of item 8, 11, 13-15, 24, 27-35; range -4 to 56); Activities of daily living (sum of item 12, 22, 23, 25, 26; range 0 to 20); Symptoms (sum of item 1-7, 9; range 0 to 32); Small fiber (sum of item 10, 16, 17, 18; range 0 to 16); Autonomic (sum of item 19, 20, 21; range 0 to 12) and total QOL score (sum of items 1-35) range: -4 to 136. Higher score implied worse QOL.|Week 19|FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Missing data were imputed using LOCF. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
831851|NCT01243320|Primary|Change In Alanine Aminotransferase Blood Level|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days|||u/L||95% Confidence Interval|Mean
811024|NCT01057693|Secondary|Quality of Life Questionnaire– Diabetic Neuropathy (QOL-DN) (Single-Blind Phase)|QOL-DN: 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy. Consists of 5 domains: Physical functioning(Ph Fn)/large fiber (sum of item 8, 11, 13-15, 24, 27-35; range -4 to 56); Activities of daily living (sum of item 12, 22, 23, 25, 26; range 0 to 20); Symptoms (sum of item 1-7, 9; range 0 to 32); Small fiber (sum of item 10, 16, 17, 18; range 0 to 16); Autonomic (sum of item 19, 20, 21; range 0 to 12) and total QOL score (sum of items 1-35) range: -4 to 136. Higher score implied worse QOL.|SB Baseline, Week 6|SBAS included all participants who were enrolled into the single-blind treatment phase and received at least 1 dose of study treatment. Here “n” signifies participants who were evaluable for specified time point.||units on a scale||Standard Deviation|Mean
811025|NCT01057693|Secondary|Endpoint Mean Sleep Interference Score (Double-Blind Phase)|Endpoint mean sleep interference score was defined as the mean of the last 7 sleep interference diaries while receiving DB treatment. Participants rated how painful DPN has interfered with their sleep during the past 24 hours on an 11-point numeric rating scale ranging from 0 = does not interfere to 10 = completely interferes (unable to sleep due to pain).|Week 19|FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Missing data were imputed using LOCF. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
811026|NCT01057693|Secondary|Endpoint Mean Sleep Interference Score (Single-Blind Phase)|Endpoint mean sleep interference score was defined as the mean of the last 7 sleep interference diaries while receiving SB treatment. Participants rated how painful DPN has interfered with their sleep during the past 24 hours on an 11-point numeric rating scale ranging from 0 = does not interfere to 10 = completely interferes (unable to sleep due to pain).|Week 6|SBAS included all participants who were enrolled into the single-blind treatment phase and received at least 1 dose of study treatment. Missing data were imputed using LOCF. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
811027|NCT01057693|Secondary|Weekly Mean Sleep Interference Score (Double-Blind Phase)|Weekly mean sleep interference score was defined as the mean of the daily sleep interference diary ratings split into 7 day intervals. Participants rated how painful DPN has interfered with their sleep during the past 24 hours on an 11-point numeric rating scale ranging from 0 = does not interfere with sleep to 10 = completely interferes (unable to sleep due to pain).|DB Baseline, Week 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19|FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Here “n” signifies participants who were evaluable for specified time-point for each arm group, respectively.||units on a scale||Standard Deviation|Mean
811028|NCT01057693|Secondary|Weekly Mean Sleep Interference Score (Single-Blind Phase)|Weekly mean sleep interference score was defined as the mean of the daily sleep interference diary ratings split into 7 day intervals. Participants rated how painful DPN has interfered with their sleep during the past 24 hours on an 11-point numeric rating scale ranging from 0 = does not interfere with sleep to 10 = completely interferes (unable to sleep due to pain). SB baseline refers to the last 7 pain diary entries up to and including Day 1.|SB Baseline, Week 1, 2, 3, 4, 5, 6|SBAS included all participants who were enrolled into the single-blind treatment phase and received at least 1 dose of study treatment. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants who were evaluable for specified time point.||units on a scale||Standard Deviation|Mean
811029|NCT01057693|Secondary|Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) (Double-Blind Phase)|MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awaken short of breath or with headache, sleep adequacy, somnolence, sleep quantity, optimal sleep, and 9 item index measures of sleep disturbance provide composite scores: sleep problems index. Participants responded whether their sleep was optimal or not optimal by choosing yes or no.|Week 19|FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment.||participants|||Number
811030|NCT01057693|Secondary|Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) (Single-Blind Phase)|MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awaken short of breath or with headache, sleep adequacy, somnolence, sleep quantity, optimal sleep, and 9 item index measures of sleep disturbance provide composite scores: sleep problems index. Participants responded whether their sleep was optimal or not optimal by choosing yes or no.|SB Baseline, Week 6|SBAS included all participants who were enrolled into the single-blind treatment phase and received at least one dose of study medication.||participants|||Number
811031|NCT01057693|Secondary|Medical Outcomes Study -Sleep Scale (MOS-SS) (Double-Blind Phase)|Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales: sleep disturbance (range 0-100), snoring (range 0-100), awaken short of breath (SOB) or with headache (range 0-100), sleep adequacy (range 0-100), somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes/no), and 9 item index measures of sleep disturbance provide composite scores: sleep problems index (range 0-100). Except adequacy, optimal sleep and quantity, higher scores=more impairment.|Week 19|FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
811032|NCT01057693|Secondary|Medical Outcomes Study -Sleep Scale (MOS-SS) (Single-Blind Phase)|Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales: sleep disturbance (range 0-100), snoring (range 0-100), awaken short of breath (SOB) or with headache (range 0-100), sleep adequacy (range 0-100), somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes/no), and 9 item index measures of sleep disturbance provide composite scores: sleep problems index (range 0-100). Except adequacy, optimal sleep and quantity, higher scores=more impairment.|SB Baseline, Week 6|SBAS included all participants who were enrolled into the single-blind treatment phase and received at least one dose of study medication. Here “n” signifies participants who were evaluable for specified time-point.||units on a scale||Standard Deviation|Mean
831852|NCT01243320|Primary|Change In Aspartate Aminotransferase Blood Level|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days|||u/L||95% Confidence Interval|Mean
811033|NCT01057693|Secondary|Patient Global Impression of Change (PGIC) (Double-Blind Phase)|PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Number of participants in each category are reported.|Week 19|FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||participants|||Number
811034|NCT01057693|Secondary|Patient Global Impression of Change (PGIC) (Single-Blind Phase)|PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Number of participants in each category are reported.|Week 6|SBAS included all participants who were enrolled into the single-blind treatment phase and received at least one dose of study treatment. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||participants|||Number
811035|NCT01057693|Secondary|Percentage of Participants With At Least 30 Percent and 50 Percent Reduction in Mean Pain Score (Double-Blind Phase)|Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. Percentage of participants who had at least 30% and 50% pain reduction from SB baseline to Week 19 is reported.|Week 19|FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Missing data were imputed using LOCF.||percentage of participants|||Number
811036|NCT01057693|Secondary|Percentage of Participants With At Least 30 Percent and 50 Percent Reduction in Mean Pain Score (Single-Blind Phase)|Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. Percentage of participants who had at least 30% and 50% pain reduction from SB baseline to Week 6 is reported. SB baseline refers to the last 7 pain diary entries up to and including Day 1.|Week 6|SBAS included all participants who were enrolled into the single-blind treatment phase and received at least 1 dose of study treatment. Missing data were imputed using LOCF.||percentage of participants|||Number
811037|NCT01057693|Secondary|Weekly Mean Pain Scores (Double-Blind Phase)|Weekly mean pain score was defined as the mean of the daily diary pain ratings split into 7 day intervals. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. SB baseline refers to the last 7 pain diary entries up to and including Day 1. DB baseline refers to the last 7 pain diary entries up to and including DB Day 1.|DB Baseline, Week 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19|FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Here “n” signifies participants who were evaluable for specified time-point for each arm group, respectively.||units on a scale||Standard Deviation|Mean
811038|NCT01057693|Secondary|Weekly Mean Pain Scores (Single-Blind Phase)|Weekly mean pain score was defined as the mean of the daily diary pain ratings split into 7 day intervals. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain.|Week 1, 2, 3, 4, 5, 6|SBAS included all participants who were enrolled in single-blind treatment phase and received at least one dose of study treatment. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants who were evaluable for specified time-point.||units on a scale||Standard Deviation|Mean
811039|NCT01057693|Secondary|Change From Single-Blind Baseline in Mean Pain Score at Week 6 During Single-Blind Phase|Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. SB baseline refers to the last 7 pain diary entries up to and including Day 1.|SB Baseline, Week 6 (SB Phase)|Single-Blind Analysis Set (SBAS) included all participants who were enrolled in single-blind treatment phase and received at least 1 dose of study treatment. “N” (number of participants analyzed): participants who were evaluable for this measure and “n”: participants who were evaluable for specified time-point. Missing data were imputed using LOCF.||units on a scale||Standard Deviation|Mean
811040|NCT01057693|Secondary|Time to Loss of Pain Response (Double-Blind Phase)|Time to loss of pain response (based on the daily pain diary data) during the DB treatment phase was analyzed using survival analysis technique. Loss of pain response was defined as less than (<) 15% pain response relative to the SB baseline. SB baseline refers to the last 7 pain diary entries up to and including Day 1.|SB Baseline up to Week 19|FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment.||days||95% Confidence Interval|Median
811041|NCT01057693|Primary|Change From Single-Blind Baseline in Mean Pain Score at Week 19 During Double-Blind Phase|Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. SB baseline refers to the last 7 pain diary entries up to and including Day 1.|SB Baseline, Week 19 (DB Phase)|Full analysis set (FAS) included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Missing data were imputed using Last Observation Carried Forward (LOCF).||units on a scale||Standard Deviation|Mean
811067|NCT01051739|Primary|Number of Subjects Progressing in Each Group Using Pointwise Linear Regression|Perimetric method that most efficiently detects visual field change. secondary outcome: number of subjects progressing in each group using pointwise linear regression Linear regression was used to determine visual field worsening (progression) at each of 52 test locations. We required 3 or more worsening test locations at a p = 0.05 significance level for their to be significant progression.|4 years|Those that completed study||participants|||Number
811068|NCT01051778|Secondary|Spontaneous Osteoporotic Fractures||Duration of pregnancy and puerperium||||||
811069|NCT01051778|Secondary|Preterm Delivery||24 weeks gestation<Pregnancy <37weeks gestation||||||
811042|NCT01057810|Secondary|Number of Treated Participants With Grade 3 or 4 Clinical Laboratory Abnormalities|"NCI CTC, Version 3 used to assess parameters. LLN=lower limit of normal. ULN=upper limit of normal. CTC criteria:
White blood cells (WBC): Gr 3:<2.0 to 1.0*10^9/L, Gr 4:<1.0*10^9/L. Absolute neutrophil count (ANC): Gr 3:<1.0 to 0.5*10^9/L, Gr 4:<0.5*10^9/L.
Platelet count: Gr 3:<50.0 to 25.0*10^9/L, Gr 4:<25.0 to 10^9/L. Hemoglobin: Gr 3:<8.0 to 6.5 g/dL, Gr 4:<6.5 g/dL. Absolute Lymphocyte Count (ALC): Gr 3: 0.2 - <0.5*10^9/L, Gr 4: <0.2*10^9/L.
Lipase: Gr 3:> 2.0 - 5.0 * ULN; Gr 4: > 5.0 X ULN. Amylase: Gr 3: > 2.0 - 5.0 * ULN; Gr 4: > 5.0 * ULN. Alanine Aminotransferase (ALT) Gr 3: > 5.0 - 20.0 * ULN; Gr 4: > 20.0 * ULN. Aspartate Aminotransferase (AST): Gr 3: > 5.0 - 20.0 * ULN; Gr 4: > 20.0 * ULN. Bilirubin: Gr 3: > 3.0 - 10.0 * ULN; Gr 4: > 10.0 * ULN. Alkaline Phosphatase: Gr 3: > 5.0 - 20.0 * ULN; Gr 4: > 20.0 * ULN. Creatinine: Gr 3: > 3.0-6.0 * ULN, Gr 4: >6.0 * ULN."|Randomization up to April 2015, approximately 57 months|All treated participants with on-study laboratory results||participants|||Number
811043|NCT01057810|Secondary|Number of Participants Who Died or Had Adverse Events (AEs), Serious Adverse Events (SAEs), Immune-related AEs (irAEs), or Immune-mediated Adverse Reactions (imARs)|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. irAE=AEs consistent with an immune mediated mechanism. imAR=AEs of special interest that were adjudicated as imAR by investigator. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. Events were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|Day 1 of study therapy to last dose plus 70 days|All treated participants||participants|||Number
811044|NCT01057810|Secondary|Time to Pain Progression|"Time to pain progression was defined as the time from randomization to the time of the earliest date of any of the following 4 events: 1) an increase in average daily worst pain intensity of >= 2 points from baseline according to the Brief Pain Inventory - Short Form (BPI-SF), maintained over 2 consecutive time periods. 2) initiation of opioid analgesic (excluding codeine or dextropropoxyphene). 3) initiation of palliative radiotherapy for prostate cancer. 4) increase in mean Analgesic Score (AS) of >= 25% from baseline (for participants with baseline AS > 10) or increase in mean AS >= 10 points from baseline (for participants with baseline AS <= 10).
Participants who did not experience any of these events were censored on the earliest date among the latest BPI-SF completion date with non-missing worst pain assessment and last evaluable disease assessment date as defined in the PFS censoring mechanism."|Randomization until pain progression, up to April 2015, approximately 57 months|All randomized participants||months||95% Confidence Interval|Median
811045|NCT01057810|Secondary|Time to Subsequent Non-hormonal Cytotoxic Therapy|For participants who discontinued treatment or experienced disease progression while on study therapy and then received subsequent non-hormonal cytotoxic therapy, time to subsequent non-hormonal cytotoxic therapy was defined as the time from randomization to the time of initiation of subsequent non-hormonal cytotoxic therapy. Participants who did not receive subsequent non-hormonal cytotoxic therapy were censored on the last known alive date (for participants who have not died) or the date of last follow-up contact at which the participants was known alive (for participants who died).|Randomization until subsequent non-hormonal cytotoxic therapy, up to April 2015, approximately 57 months|All randomized participants who received subsequent non-hormonal cytotoxic therapy||months||95% Confidence Interval|Median
811046|NCT01057810|Secondary|Progression-Free Survival (PFS) Time|Progression-free survival, as determined by the investigator, was defined as the time from randomization to the earliest date of confirmed Prostate-Specific Antigen (PSA) progression, confirmed radiological progression, clinical deterioration, or death.|Randomization until disease progression, up to April 2015, approximately 57 months|All randomized participants||months||95% Confidence Interval|Median
811047|NCT01057810|Primary|Overall Survival (OS) Time|OS was defined as the time from the date of randomization until the date of death. For participants without documentation of death, OS was censored at the last date the participant was known to be alive.|Randomization until death from any cause, up to April 2015, approximately 57 months|All randomized participants||months||95% Confidence Interval|Median
811050|NCT01057888|Primary|Well Child Care Status|Received recommended well child care visit|12 months|||participants|||Number
811051|NCT01057888|Primary|Fully Vaccinated (Tdap, Menactra and 3 Doses of HPV (if Female))||12 months|Individuals were randomized to one of 3 groups (letter reminders, telephone reminders or control). Individuals with a wrong/missing telephone number or a wrong address were excluded from the analyses. This left 1,396 in the letter reminder group, 1,423 in the telephone reminder group and 1,296 in the control group.||participants|||Number
811052|NCT01057901|Primary|Change From Baseline in the Score on the Female Sexual Function Index (FSFI) Desire Domain|The Female Sexual Function Index (FSFI) is a brief, multidimensional, self-administered questionnaire for assessing key domains of sexual function in women. The scale consists of 19 items that assess sexual function over the past four weeks and yields scores in six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. The two items in the desire domain are scored from 1 to 5 (1 is lowest level of desire and 5 is the highest level of desire). The raw scores of the two items are added together and then multiplied by the domain factor of 0.6. Thus, the score of the desire domain ranges from 1.2 (lowest level of desire) to 6.0 (highest level of desire). For the entire instrument, each of the six domains contributes a maximum of 6 points to the total. Scores on the full scale range from a minimum of 2 to a maximum of 36.|baseline to 24 weeks|The full analysis set (FAS), consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, had at least one baseline value of either one of the co-primary endpoints or key secondary endpoint, and had usable data.||units on a scale||Standard Error|Least Squares Mean
811053|NCT01057901|Primary|Change From Baseline in the Number of Satisfying Sexual Events|"The change from baseline in the number of SSE’s as measured by the eDiary. The calculation of Satisfying Sexual Event (SSEs) will be standardized to a 28-day period according to the below formula:
Total monthly events = 28 x (sum of the number of events) / (sum of number of days entered).
Satisfying means gratifying, fulfilling, satisfactory, and/or successful for the patient. The partner's satisfaction is not the subject of this question."|baseline to 24 weeks|The full analysis set (FAS), consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, had at least one baseline value of either one of the co-primary endpoints or key secondary endpoint, and had usable data.||SSEs/month||Standard Deviation|Mean
811054|NCT01058005|Primary|Incidence of Treatment-emergent Serious Adverse Events (SAEs)|An SAE was defined as any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the subject at immediate risk of death (a life-threatening event; however, this does not include an event that, had it occurred in a more severe form, might have caused death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect. An SAE may also have been any other medically important event that, in the opinion of the Investigator, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed in the definition above. See Adverse Events section below for further details.|up to 108 Weeks|Participants who received at least 1 dose of study medication.||participants|||Number
811055|NCT01058070|Primary|To Monitor the Improvement of GERD Symptoms.|Percentage of participants with a 50% or more reduction in total GERD-HRQL score is indicative of a substantial improvement in GERD symptoms|5 years|||percentage of participants|||Number
811056|NCT01058070|Primary|To Evaluate the Incidence of All Adverse Events at Various Time Points.||5 years|||participants|||Number
811057|NCT01058096|Secondary|Change From Baseline in Clinical Global Impression–Severity (CGI-S) Total Score at Week 3|The CGI-S measures the investigator’s assessment of overall severity of the participant’s illness compared with the severity of illness in other patients the physician has observed using a 7-point scale (1=Normal, not ill at all to 7=Among the most extremely ill participants). A negative change from Baseline indicates improvement. Analysis was based on a MMRM using the observed cases (OC) data, with treatment group, pooled study center, visit, treatment group-by-visit interaction as factors, baseline value and baseline-by-visit interaction as covariates and an unstructured covariance matrix.|Baseline, Week 3|Intent-to-treat Population included all participants who received at least 1 dose of study drug and who had at least 1 post-baseline YMRS assessment.||score on a scale||Standard Error|Least Squares Mean
811058|NCT01058096|Primary|Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Week 3|The YMRS is an 11-item scale that assesses manic symptoms based on the participant’s perception of his or her condition over the previous 48 hours, as well as the physician’s clinical observations during the interview. The 11-items are elevated mood, increased motor activity-energy, sexual interest, sleep, irritability, rate and amount of speech, language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight. The severity of the abnormality for 7-items are rated on a 5-point scale (0-4) and 4-items on a 9-point scale (0-8). The individual scores are summed for a total possible score of 0 (best) to 60 (worst). A negative change from Baseline indicates improvement. Analysis was a mixed model for repeated measurements (MMRM) observed cases (OC), with treatment group, pooled study center, visit, treatment group-by-visit interaction as factors, baseline value and baseline-by-visit interaction as covariates and an unstructured covariance matrix.|Baseline, Week 3|Intent-to-treat Population included all participants who received at least 1 dose of study drug and who had at least 1 post-baseline YMRS assessment.||score on a scale||Standard Error|Least Squares Mean
811059|NCT01051557|Primary|Determine the Efficacy of Temsirolimus in Combination With Perifosine in Patients With Recurrent/Progressive Glioblastomas (GBMs) Not Taking EIAEDs as Measured by 6 Month Progression-free Survival (6mPFS) and Radiographic Response Rates. (Phase II)|This data has yet to be analyzed.|5 years||||||
811060|NCT01051557|Primary|Maximum Tolerated Dose of Temsirolimus|MTD defined as the dose at which fewer than one-third of patients experience a dose limiting toxicity (DLT) according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (Phase I)|28 days|||mg/week|||Number
811061|NCT01051570|Secondary|Overall Survival||After treatment, participants will be contacted every 3 months||||||
811062|NCT01051570|Secondary|Pharmacokinetics||Samples will be collected Cycle 1, day 1, 2 & 8 and Cycle 2, Day 1 & 2||||||
811063|NCT01051570|Secondary|Association of TTP and PSA Response Rate With Correlative Markers (Phospho mTOR, pAKT, and p70S6)||Archival tissue will be collected if available. Optional biopsies pre-treatment and 24 hours after first everolimus and carboplatin dose||||||
811064|NCT01051570|Secondary|PSA Response Rate||Day 1 of each cycle (every 21 days)||||||
811065|NCT01051570|Secondary|Toxicity as Measured by NCI CTCAE v3.0 Criteria||Day 1 of each cycle (every 21 days)||||||
811066|NCT01051570|Primary|Time to Progression (TTP)|Progression defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Up to 63 days while on treatment, then up 90 days thereafter. From date of registration to date of progressive disease.|||months||90% Confidence Interval|Median
811077|NCT01051817|Primary|Summary of Raw Number of Cumulative Combined Unique Active Lesions in Patients With Relapsing Remitting Multiple Sclerosis by Visit and Treatment|Combined unique active lesions (CUAL) observed on brain MRI scans performed every 4th week from week 4 to week 24 in patients with relapsing-remitting multiple sclerosis (RRMS). CUAL is defined as: new gadolinium (Gd)-enhancing lesions on T1-weighted, or new or enlarging lesions on T2-weighted MRI scans, without double counting.|weeks 4,8,12,16,20,24,28|Full Analysis Set||Combined Unique Active Lesions||Full Range|Mean
811078|NCT01051856|Secondary|Severity of the Pancreatic Fistula Leaks|Grading of the clinical severity of the leak was done according to the International Study Group on Pancreatic Fistula criteria. Severity of fistula was reported as clinically significant (Grades B and C) or not (Grade A). Grade C indicates the most severe clinical outcome.|90 days post operative|||Pancreatic fistula leaks|||Number
811079|NCT01051856|Primary|Percentage of Subjects Who Developed a Postoperative Pancreatic Duct Leak at the Resection Margin (Pancreatic Fistula) Within 90 Days From the Operation|Pancreatic fistula was defined as amylase-rich (greater than 3 times upper limit of normal serum amylase for the treating institution) fluid either in the operatively placed drain or upon reinsertion of an image-guided drain for postoperative fluid collection.|90 days from the operation|Intention-to-treat analysis||percentage of subjects|||Number
811080|NCT01051921|Secondary|> 2 Log Decline in Hepatitis C Virus Ribonucleic Acid (HCV-RNA) at 24 Weeks|"Percent of patients experiencing a drop in HCV-RNA Hepatitis C virus ribonucleic acid, also known as viral load) levels in the blood equal to, or greater than, 2 log from before treatment (baseline) through 24 weeks of treatment."|Baseline and Study week 24|Although this study was completed, the entire CTS-1027 program was discontinued prior to database lock. Therefore, efficacy analysis was not completed for this study.||Percent of patients|||Number
811081|NCT01051921|Primary|Early Virologic Response (EVR)|"Early Virologic Response (EVR) is defined as the percent of patients who experienced a drop in HCV-RNA (Hepatitis C Ribonucleic acid, also known as viral load) levels of more that 2 log from before treatment (baseline) through 12 Weeks of treatment."|Baseline and Study week 12|Although this study was completed, the entire CTS-1027 program was discontinued prior to database lock. Therefore, efficacy analysis was not completed for this study.||Percent of Patients|||Number
811082|NCT01051986|Secondary|Early Angiographic Patency Rates|The patency rate of the SV side-arm composite graft evaluated with coronary angiograms early after CABG|1.4days|||percentage of distal anastomoses|Participants||Number
811083|NCT01051986|Secondary|Freedom From MACCE(Major Adverse Cardiac and Cerebrovascular Events)|freedom from MACCE(major adverse cardiac and cerebrovascular events)at 4 years|4 years|||percentage of participants|||Number
811084|NCT01051986|Secondary|Freedom From Cardiac Death|Freedom rate from cardiac death at 4 years|4 years|||percentage of participants|||Number
811085|NCT01051986|Secondary|Overall Survival|Overall survival rate at 4 years|4 years|||percentage of participiciants|||Number
811086|NCT01051986|Primary|1 Year Graft Patency Rates|1 year graft patency of second limb conduits measured by 1 year coronary angiography|one year|||percentage of distal anastomoses|Participants||Number
811087|NCT01052038|Secondary|Hoarseness at 24 Hours|Self assessment of the degree of hoarseness 24 hours after surgery and intratracheal intubation on a 1 to 1 Likert scale. 0 = no hoarseness and 3= hoarseness easily noted at time of interview.|24 hours|||participants|||Number
811088|NCT01052038|Secondary|Opioid Consumption at 24 Hours|The cumulative use of an opioid analgesic pain medication taken during the first 24 hours for pain and discomfort. Data reported as equivalent dose of oral morphine.|24 hours|||mg of oral morphine equivalents||Inter-Quartile Range|Median
811089|NCT01052038|Secondary|Number of Subjects With Sore Throat at 3 Hours Post Surgery.|Subjects were asked at 3 hours post surgery if they were experiencing a sore throat.|3 hours.|||participants|||Number
811090|NCT01052038|Secondary|Quality of Recovery at 24 Hours|The quality of recovery (QoR-40) questionnaire assess the subjects perceived quality of recovery following surgery. The tool assess pain, physical and psychological well being as well as ability to ability for self-care. Questions are scored on a 1 to 5 point scale with a higher value indication a better outcome. The scores or the individual questions are summed to obtain a total score. The minimum total score is 30 and the maximum is 200. The higher the score the better the recovery|24 hours|||units on a scale (30 to 200) higher scod||Inter-Quartile Range|Median
811091|NCT01052038|Primary|Subjects Assessment of Sore Throat Pain at 24 Hours|The reported score for sore throat on a 1 to 5 scale where 1 is a severe sore throat and 5 is no sore throat. This evaluation was made by investigator initiated phone conversation at 24 hours following surgery.|24 hours|||units on a scale (1 to 5)||Inter-Quartile Range|Median
811092|NCT01052077|Secondary|Number of Participants With CGI-Improvement Response During Phase B Relative to the End of Phase A (Week 8).|CGI-I Response was defined as a CGI-I score of 1 (very much improved) or 2 (much improved).|Baseline (end of week 8) to Week 14|The efficacy sample was the FAS comprised of participants who received 1 dose of double-blind study medication and had both end of Week 8 visit value and 1 post-randomization efficacy assessment for MADRS total score in double-blind Phase B. The LOCF method was used to impute missing data.||participants|||Number
811093|NCT01052077|Secondary|Number of Participants With MADRS Remission During Phase B Relative to the End of Phase A (Week 8) Visit.|A MADRS remission was defined as MADRS Total Score =< 10 and >= 50 percent reduction in MADRS Total Score from end of Phase A (Week 8 visit). The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the “best” rating and 6 being the “worst” rating. The MADRS Total Score is the sum of ratings for all 10 items; therefore, possible total scores range from 0 to 60. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place.|Baseline (end of week 8) to Week 14|The efficacy sample was the FAS comprised of participants who received 1 dose of double-blind study medication and had both end of Week 8 visit value and 1 post-randomization efficacy assessment for MADRS total score in double-blind Phase B. The LOCF method was used to impute missing data.||participants|||Number
811129|NCT01060124|Secondary|Difference in Pain Intensity Before and After Administration of (TTS)-Fentanyl D-trans|Pain intensity difference was measured by Visual Analog Scale (VAS) score, which ranges from 0 to 10 centimeter (cm) where 0 cm=no pain and 10 cm= unimaginably severe pain.|Day 1 and Day 29|Full Analysis (FAS) population included all participants who meet the inclusion and exclusion criteria.||units on a scale||Standard Deviation|Mean
811094|NCT01052077|Secondary|Number of Participants With MADRS Response During Phase B Relative to the End of Phase A (Week 8) Visit.|A MADRS response was defined as >=50 percent reduction in MADRS Total Score from end of Phase A (Week 8 visit). The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the “best” rating and 6 being the “worst” rating. The MADRS Total Score is the sum of ratings for all 10 items; therefore, possible total scores range from 0 to 60. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place.|Baseline (end of week 8) to Week 14|The efficacy sample was the FAS comprised of participants who received 1 dose of double-blind study medication and had both end of Week 8 visit value and 1 post-randomization efficacy assessment for MADRS total score in double-blind Phase B. The LOCF method was used to impute missing data.||participants|||Number
811095|NCT01052077|Secondary|Clinical Global Impression- Improvement Scale (CGI-I) Score by Study Week in Phase B Relative to End of Phase A.|The efficacy of study medication was rated for each participant using the CGI-I. The study physician would rate the participants total improvement whether or not it is due entirely to drug treatment. Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.|Baseline (end of week 8) to Week 14|The efficacy sample was the FAS comprised of participants who received 1 dose of double-blind study medication and had both end of Week 8 visit value and 1 post-randomization efficacy assessment for MADRS total score in double-blind Phase B. The LOCF method was used to impute missing data.||Units on a scale||Standard Deviation|Mean
811096|NCT01052077|Secondary|Change From End of Phase A (Week 8) to End of Phase B (Week 14) in the Hamilton Depression Rating Scale 17-item Version (HAM-D17) Total Score.|The HAM-D17 was utilized as a secondary assessment of a participants level of depression. The HAM-D (17-Item) consisted of 17 items. Eight items were rated on a 0 to 2 scale (items 4, 5, 6, 12, 13, 14, 16 and 17), while nine items (items 1, 2, 3, 7, 8, 9, 10, 11, and 15) were rated on a 0 to 4 scale (twice the weight of the other items). For all of these items, 0 was the “best” rating and the highest score (2 or 4) was the “worst” rating. The possible total scores were from 0 to 52.|Baseline (end of week 8) to Week 14|The efficacy sample was the FAS comprised of participants who received 1 dose of double-blind study medication and had both end of Week 8 visit value and 1 post-randomization efficacy assessment for MADRS total score in double-blind Phase B. The LOCF method was used to impute missing data.||Units on a scale||Standard Error|Least Squares Mean
811097|NCT01052077|Secondary|Change From End of Phase A (Week 8 Visit) to Phase B by Study Week in Inventory of Depressive Symptomatology (Self-Report) (IDS-SR) Total Score.|The IDS-SR was a 30-item self-report measure, that was used to assess core diagnostic depressive symptoms as well as atypical and melancholic symptom features of major depressive disorder (MDD). For individual items, the scores range from 0 to 3. The IDS-SR are scored by summing responses to 28 of the 30 items to obtain a total score ranging from 0 to 84, higher values indicate greater disruption in the depressive symptoms.|Baseline (end of week 8) to Week 14|The efficacy sample was the FAS comprised of participants who received 1 dose of double-blind study medication and had both end of Week 8 visit value and 1 post-randomization efficacy assessment for MADRS total score in double-blind Phase B. The LOCF method was used to impute missing data.||Units on a scale||Standard Error|Least Squares Mean
811098|NCT01052077|Secondary|Change From End of Phase A (Week 8 Visit) to Phase B by Study Week in Clinical Global Impression- Severity Illness Scale (CGI-S) Score.|The severity of illness for each participant was rated using the CGI-S. To perform this assessment, the investigator had to answer the following question: “Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?” Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.|Baseline (end of week 8) to Week 14|The efficacy sample was the FAS comprised of participants who received 1 dose of double-blind study medication and had both end of Week 8 visit value and 1 post-randomization efficacy assessment for MADRS total score in double-blind Phase B. The LOCF method was used to impute missing data.||Units on a scale||Standard Error|Least Squares Mean
811099|NCT01052077|Secondary|Change From End of Phase A (Week 8 Visit) in MADRS Total Score for Every Trial Week Visit in Phase B.|The MADRS was utilized as the primary efficacy assessment of a participants level of depression. The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the “best” rating and 6 being the “worst” rating. The MADRS Total Score is the sum of ratings for all 10 items; therefore, possible total scores range from 0 to 60. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place.|Baseline (end of week 8) to Week 14|The efficacy sample was the FAS comprised of participants who received 1 dose of double-blind study medication and had both end of Week 8 visit value and 1 post-randomization efficacy assessment for MADRS total score in double-blind Phase B. The LOCF method was used to impute missing data.||Units on a scale||Standard Error|Least Squares Mean
811100|NCT01052077|Secondary|Change From End of Phase A (Week 8) to Phase B in Sheehan Disability Scale (SDS) Score.|The SDS was a self-rated instrument used to measure the effect of the participants symptoms on work/school, social life, and family/home responsibilities. For each of the three items, scores ranged from 0 through 10. The number most representative of how much each area was disrupted by symptoms was marked along the line from 0= not at all, to 10= extremely. Scores of 5 and above are associated with significant functional impairment. The SDS total score ranges from 0 to 30, with higher values indicating greater disruption in the participant's work/social/family life. For the work/school item, no response was to be entered if the participant did not work or go to school for reasons unrelated to the disorder and a response therefore not being applicable. The Mean SDS score were calculated over the three item scores. All three item scores were needed to be available with the exception of the work/school item score when this item was not applicable.|Baseline (end of week 8) to Week 14|The efficacy sample was the FAS comprised of participants who received 1 dose of double-blind study medication and had both end of Week 8 visit value and 1 post-randomization efficacy assessment for MADRS total score in double-blind Phase B. The LOCF method was used to impute missing data.||Units on a scale||Standard Error|Least Squares Mean
831853|NCT01243320|Primary|Change In Alkaline Phosphatase Blood Level|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days|||u/L||95% Confidence Interval|Mean
811101|NCT01052077|Primary|Change From the End of Phase A (Week 8 Visit) to the End of Phase B (Week 14 Visit) in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score.|The MADRS was utilized as the primary efficacy assessment of a participants level of depression. The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the “best” rating and 6 being the “worst” rating. The MADRS Total Score is the sum of ratings for all 10 items; therefore, possible total scores range from 0 to 60. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place.|Baseline (end of week 8) to Week 14|The efficacy sample was the Full Analysis Set (FAS) comprised of participants who received 1 dose of double-blind study medication and had both end of Week 8 visit value and 1 post-randomization efficacy assessment for MADRS total score in double-blind Phase B. The LOCF method was used to impute missing data.||Units on a scale||Standard Error|Least Squares Mean
811102|NCT01058265|Primary|Short Form 36 (SF-36) Mental Component Summary (MCS)|It yields an eight-scale profile of scores (physical functioning, social functioning, role-physical, role-emotional, bodily pain, general health, mental health, and vitality) as well as summary physical and mental measures (Ware et al., 1998). The Mental Component Summary ranges from 0 to 100, and higher score indicates better mental health status. It is based on norm-based scoring, which applies a transformation with mean equals to 50 and standard deviation equals to 10, and makes it possible to comparison.|3 months|||Scores on a scale||Inter-Quartile Range|Median
811103|NCT01058265|Primary|Short Form 36 (SF-36) Physical Component Summary (PCS)|It yields an eight-scale profile of scores (physical functioning, social functioning, role-physical, role-emotional, bodily pain, general health, mental health, and vitality) as well as summary physical and mental measures (Ware et al., 1998). The Physical Component Summary ranges from 0 to 100, and higher score indicates better physical condition. It is based on norm-based scoring, which applies a transformation with mean equals to 50 and standard deviation equals to 10, and makes it possible to comparison.|3 months|||Scores on a scale||Inter-Quartile Range|Median
811104|NCT01058304|Secondary|Short Performance Physical Battery (SPPB)|"This battery of objective physical function tests examines participants’ balance (3 tests), gait speed (8-foot walk), and time to rise from a chair and return to the seated position five times. For each test, the possible range if scores is 0-4, for a total range of 0-20 for all five tests, with higher scores indicating better function.
Note that the baseline mean is a common baseline mean generated from the mixed model used for the primary study analysis. The raw mean for this outcome, overall and by study group, is presented in the table of baseline participant characteristics."|12 weeks|All enrolled, randomized participants||units on a scale||95% Confidence Interval|Mean
811105|NCT01058304|Primary|Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC)|"WOMAC is a measure of lower extremity pain (5 items), stiffness (2 items), and function (17 items). All items are rated on a Likert scale of 0 (no symptoms) to 4 (extreme symptoms). The total score ranges from 0-96, with higher scores indicating worse symptoms.
Note that the baseline mean is a common baseline mean generated from the mixed model used for the primary study analysis. The raw mean for this outcome, overall and by study group, is presented in the table of baseline participant characteristics."|12-weeks, 24-weeks|All enrolled, randomized participants||units on a scale||95% Confidence Interval|Mean
811106|NCT01058356|Secondary|Presence of Bowel Habit Change (Watery Stools More Than 2 Times Per Day for at Least 2 Days)||Up to14 days|||participants|||Number
811107|NCT01058356|Primary|Presence of AAD|AAD defined as: Watery stools more than 3 times per day for at least 2 days.|Up to 14 days|||participants|||Number
811108|NCT01058421|Secondary|Institution Free Days|Median number of days subjects were alive and free of hospitalization or living in a long-term care, rehabilitation, or skilled nursing facility.|Day 180|"Deceased subjects were not included in subsequent Period beginning subject started totals.
55 (subjects started Period 1) minus 13 (deceased subjects in Periods 1 & 2) = 46 started Period 3.
61 (subjects started Period 1) minus 11 (deceased subjects in Periods 1 & 2) = 50 started Period 3."||Days||Inter-Quartile Range|Median
811109|NCT01058421|Secondary|Institution Free Days|Median number of days subjects were alive and free of hospitalization or living in a longer-term care, rehabilitation, or skilled nursing facility.|At Day 90|"Deceased subjects were not included in subsequent Period beginning subject started totals.
59 (Subjects started Period 1) minus 10 (deceased subjects during Period 1) = 49 started Period 2.
61 (Subjects started Period 1) minus 6 (deceased subjects during Period 1) = 55 started Period 2."||Days||Inter-Quartile Range|Median
811110|NCT01058421|Secondary|Discharged to Home|Percentage of subjects discharged to home from study hospital|Through Day 28|||percentage of participants|||Number
811111|NCT01058421|Secondary|Hospital Length of Stay|The total number of hospital days during study participation, up to 180 days.|up to 180 days|||Days||Inter-Quartile Range|Median
811112|NCT01058421|Secondary|Hospital Free Days||Through Day 28|||Days||Inter-Quartile Range|Median
811113|NCT01058421|Secondary|Mechanical Ventilation Duration|The total number of ventilated days from hospital admission to extubation, death or discharge over the complete duration of study participation, up to 180 days.|up to 180 days|||Days||Inter-Quartile Range|Median
811114|NCT01058421|Secondary|ICU Length of Stay|Median ICU length of stay through Day 28|Total Days through Day 28|||Days||Inter-Quartile Range|Median
811115|NCT01058421|Secondary|ICU-free Days|Number of ICU-free days at Day 28.|Day 28|||Days||Inter-Quartile Range|Median
811130|NCT01060124|Primary|Percentage of Participants Satisfied With Pain Treatment|Participants were assessed for their satisfaction for pain treatment after the application of the Transdermal Therapeutic System (TTS)-fentanyl D-trans.|Day 29|Per-Protocol (PP) analysis population included all participants who completed the clinical trial without violating the protocol among the participant who participated in the clinical trial.||percentage of participants||95% Confidence Interval|Number
811131|NCT01060150|Secondary|Stroop Test Score for Ratio Interference|Ratio interference is calculated by dividing simple execution time by interfering execution time. The score range is 0-1. Higher value indicates better ability of suppression of automation.|Baseline and Week 12|The ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.||Units on a scale||Standard Deviation|Mean
811116|NCT01058421|Primary|The Primary Outcome Variable for This Study Will be the Short Form of the Continuous Scale Physical Functional Performance Test (CS-PFP) Called the PFP-10|The CS-PFP-10 provides an overall score and scores for upper body strength, upper body flexibility, lower body strength, balance and coordination, and endurance. The test is used to assess an individual's overall capacity to carry out activities of daily living by measuring and quantifying 10 typical activities including sweeping a floor, transferring clothes from a washer to a dryer, and carrying groceries. Tasks are quantified using time alone, time and weight, and distance. This test provides a realistic and practical measure of movement capacity and ability to accomplish sustained activity. CS-PFP-10 scores are scored from 0 to 100, with higher scores indicating better function. If patients remained in the hospital or in a long-term care facility a the time of assessment, then received a score of 0. All tests were conducted in a standardized physical therapy laboratory by a physical therapist formally trained in conducting the CS-PFP-10 and blinded to group/arm assignment.|1 month|41 of 59 subjects were analyzed in the Intensive Treatment Group (20 completed outcomes testing + 5 remained in hospital + 16 remained in another facility = 41 subjects). 48 of 61 Standard of Care Group subjects were analyzed (19 completed outcomes testing + 12 remained in hospital + 17 remained in another facility = 48).||score||Standard Error|Mean
811117|NCT01060072|Secondary|Resolution of Anterior Chamber Flare|Complete resolution of flare, scored on a scale of 0-4 were 0=none and 4=very severe.|Visit 4-7 (postoperative day 3-18)|Intention to treat population (ITT)||participants|||Number
811118|NCT01060072|Secondary|Grade 0 Pain|Participants with no pain, graded on a 0-5 scale, 0= no pain and 5=severe pain|Visits 4-7 (Postoperative days 3-18)|Intention to treat population (ITT)||participants|||Number
811119|NCT01060072|Secondary|Resolution of Anterior Chamber Cells|Participants with complete resolution of anterior chamber cells(ACC). Cells were graded on a 0-4 scale, where 0=no cells and 4=>30 cells|Visit 4-7 (postoperative day 3-18)|Intention to treat population (ITT)||participants|||Number
811120|NCT01060072|Primary|Grade 0 Pain|Participants with no pain, graded on a 0-5 scale, 0=no pain and 5=severe pain|Visit 5 (Postoperative day 8)|Intention to treat (ITT) population||participants|||Number
811121|NCT01060072|Primary|Resolution of Anterior Chamber Cells.|Participants with complete resolution of anterior chamber cells(ACC). Cells were graded on a 0-4 scale, where 0=no cells and 4=>30 cells|Visit 5 (Postoperative day 8)|Intention to treat (ITT) population||participants|||Number
811122|NCT01060111|Secondary|Change From Baseline in Visual Analogue Scale (VAS) Score at Week 6|VAS was used to measure the intensity of migraine. The assessment scale ranges from 0 to 10. One end of the line drawn on the questionnaire is marked with 0 point indicating “no headache” and the other end with 10 points indicating “unimaginably strong headache.” It means that the higher the score, the severe the pain is. Change values were calculated as Baseline value minus value at Week 6.|Baseline and Week 6|The ITT population included all the participants who took topiramate at least once and had migraine improvement data at the Week 6. Here 'n' signifies participants evaluable for this outcome measure at given time point.||Units on a Scale||Standard Deviation|Mean
811123|NCT01060111|Secondary|Change From Baseline in Migraine Disability Assessment (MIDAS) Score at Week 6|MIDAS scoring ranges from 0 to 63. The scores are divided into ranges of disability with higher scores indicating increased disability as follows: 0-5 (Grade I - Minimal or infrequent disability); 6-10 (Grade II - Mild or infrequent disability); 11-20 (Grade III - Moderate disability); and 21+ (Grade IV - Severe disability). Change values were calculated as Baseline value minus value at Week 6.|Baseline and Week 6|The ITT population included all the participants who took topiramate at least once and had migraine improvement data at the Week 6. Here 'n' signifies participants evaluable for this outcome measure at given time point.||Units on a scale||Standard Deviation|Mean
811124|NCT01060111|Secondary|Change From Baseline in Migraine Frequency at Week 6|The migraine frequency at Week 6 was evaluated through a headache diary completed by a participant and the reduction rate of migraine frequency compared to the Baseline period was measured. Change values were calculated as Baseline value minus value at Week 6.|Baseline and Week 6|The ITT population included all the participants who took topiramate at least once and had migraine improvement data at the Week 6. Here 'n' signifies participants evaluable for this outcome measure at given time point.||Migraine episodes/Week||Standard Deviation|Mean
811125|NCT01060111|Primary|Percentage Decrease in Migraine Episodes|Decrease in percentage of migraine frequency (episodes) was measured from baseline using a headache diary which is a typical scale measuring neuropsychiatric symptoms in a migraine participant. Migraine will be diagnosed in accordance with the guidelines of the International Headache Society (IHS).|Maintenance period (Weeks 7 to 10)|The intent-to-treat (ITT) population included all the participants who took topiramate at least once and had migraine improvement data at the Week 6. Here 'N' signifies participants who were evaluated for this outcome measure.||Percentage decrease in migraine episodes||Standard Deviation|Mean
811126|NCT01060124|Other Pre-specified|Number of Participants With Investigator's Overall Evaluation on the Pain Treatment|Investigator assessed the participants for satisfaction on pain treatment after the administration of the TTS-fentanyl D-trans as very satisfied, satisfied, average, dissatisfied or very dissatisfied.|Day 29|Full Analysis (FAS) population included all those participants who meet the inclusion and exclusion criteria. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.||participants|||Number
811127|NCT01060124|Other Pre-specified|Initial and End Point Dose of TTS-Fentanyl D-trans|Dose of TTS-fentanyl D-trans were monitored at start and end of the trial.|Day 1 and Day 29|Safety population included all participants who were administered the TTS-fentanyl D-trans at least once.||microgram per hour (mcg/hr)||Standard Deviation|Mean
811128|NCT01060124|Other Pre-specified|Number of Participants With Detailed Reason for Satisfaction With the Pain Treatment|Participants were assessed for satisfaction for pain treatment after the administration of the TTS-fentanyl D-trans in detail with satisfied reasons, which are excellent pain relieving effect, convenient administration, minor adverse event, generally satisfied and other.|Day 29|Full Analysis (FAS) population included all participants who meet the inclusion and exclusion criteria. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.||participants|||Number
811158|NCT01060670|Secondary|Time to Complete Wound Closure|Time to complete wound closure, as assessed by computerized planimetry.|16 weeks|ITT population complete wound healed with analyzable data||days||Full Range|Median
811132|NCT01060150|Secondary|Stroop Test Result for False Reaction|This test consists of 3 trials: color trial (simple execution), word trial (middle execution) and word-color interference trial (interfering execution). In simple execution, participants have to read the written color names of the words independent of the color of the ink. In middle execution, participants have to read words written in black letters. In interfering experiment, participants have to say the color of the letters independent of the written word. The total value ranges from 0-24 errors for each execution where high value indicates worsening attention.|Baseline and Week 12|The ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.||Errors||Standard Deviation|Mean
811133|NCT01060150|Secondary|Stroop Test Result for Reaction Time|This test consists of 3 trials: color trial (simple execution), word trial (middle execution) and word-color interference trial (interfering execution). In simple execution, participants have to read the written color names of the words independent of the color of the ink. In middle execution, participants have to read words written in black letters. In interfering experiment, participants have to say the color of the letters independent of the written word. This test estimates spending time for execution. High spending time indicates low ability of suppression of automation.|Baseline and Week 12|The ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.||Seconds||Standard Deviation|Mean
811134|NCT01060150|Secondary|Controlled Oral Words Association Test (COWAT) Score|This test measures the executive function of the frontal lobe and is consisted of examinations of category/meaning fluency and letter/phoneme fluency. It consisted of three 60 second word generation trials in which the participant orally generates as many words as possible that begin with target letters F, A and S. Dependent variables included total number of acceptable words generated for each target letter and total number of words generated across all three letter trials. Total score was calculated as sum of acceptable words generated, with higher scores indicating better verbal fluency.|Baseline and Week 12|The ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.||Words||Standard Deviation|Mean
811135|NCT01060150|Secondary|Finger Window (FW) Test Score|In FW test, a participant shows memory of a demonstrated visual pattern using a 8x11 inch plastic template containing 9 asymmetrically located holes. The examiner models a given sequence of holes and asks the participant to imitate the sequence by placing his/her finger through the same holes in the correct order. The total number of correct sequences constitutes the total score which ranges from 0-24 (forward FW) and 0-28 (backward FW) with higher score indicating a more favorable health state.|Baseline and Week 12|The ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.||Units on a scale||Standard Deviation|Mean
811136|NCT01060150|Secondary|Digit Span Test Score|Each participant individually was given a sequence of numbers, with the sequence becoming progressively longer, to repeat the digits in the same sequence, either forwards or backwards. Each sequence length was attempted twice. The test was complete after failure on both trials of any sequence length. 1 point was awarded if the participant passed only 1 trial of a sequence length. 0 points were given if the participant failed both trials. Total score range was 0-16 (forwards) and 0-14 (backwards). A higher score was indicative of better recall and attention.|Baseline and Week 12|The ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.||Units on a scale||Standard Deviation|Mean
811137|NCT01060150|Secondary|Attention-Deficit/Hyperactivity Disorder (ADHD) Diagnostic System (ADS) Test Score for Reaction Time and Response Variability|The ADS is composed of 4 factors: omission/missing frequency to measure attention dispersibility; false alarm/comission frequency to measure impulse; mean response/reaction time to measure the speed of task processing; and the response variability/standard deviation of response time to measure the consistency of attention. The score range for both, reaction time and response variability, is 0-100. High score indicates worsening attention. If one or over factor’s score is over 65 point, the participant is resulted in having attention deficit.|Baseline and Week 12|The ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.||Units on scale||Standard Deviation|Mean
811138|NCT01060150|Secondary|Attention-Deficit/Hyperactivity Disorder (ADHD) Diagnostic System (ADS) Test Result for Omission Errors and Commission Errors|The ADS is composed of 4 factors: omission/missing frequency to measure attention dispersibility; false alarm/commission frequency to measure impulse; mean response/reaction time to measure the speed of task processing; and the response variability/standard deviation of response time to measure the consistency of attention. The total value for both, omission errors and commission errors, ranges from 0-100 errors where high value indicates worsening attention.|Baseline and Week 12|The ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.||Errors||Standard Deviation|Mean
811159|NCT01060670|Secondary|Time to Complete Wound Closure|Measures the time to complete wound closure as assessed by the Investigator.|16 weeks|ITT Population complete wound healed with analyzable data||days||Standard Deviation|Mean
811160|NCT01060670|Secondary|Incidence of Complete Wound Closure|Percentage of subjects with complete wound closure of the study ulcer, as assessed by computerized planimetry, during the treatment phase.|16 weeks|ITT Population||percentage of subjects|||Number
811161|NCT01060670|Primary|Incidence of Complete Wound Closure|100% closure as assessed by the Investigator and confirmed at 2 consecutive treatment phase visits.|16 weeks|The results were based on the Investigator assessment and ITT population.||participants|||Number
811139|NCT01060150|Primary|Learning Skill Test (LST) Total Score|The LST measures learning ability of student. This scale is composed of 7 sections: self control, participation, task accomplishment, reading, writing, test taking and information processing. It consists of 70 items for middle school student (age 13-15 years) and 80 items for high school student (age 16-18 years). Each item is rated on a 5-point Likert scale ranging from 1 (never) to 5 (always). The total score range is 70-350 for middle school version and 80-400 for high school version where higher score indicates better ability for learning. In result analysis, each sub-score and total score was converted to T-score for normalization. The score range of T-score is from 1 to 100 with a mean of 50. Higher score indicates better ability for learning.|Week 12|ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.||T-score||Standard Deviation|Mean
811140|NCT01060150|Primary|Clinical Global Impression - Improvement (CGI-I) Score|The CGI-I is a 7-point scale that requires the clinician to assess how much the participant’s illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.|Week 12|ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.||Units on a scale||Standard Deviation|Mean
811141|NCT01060150|Primary|Clinical Global Impression - Severity (CGI-S) Score|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher scores indicate worsening."|Week 12|ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Missing values at Week 12 were imputed using LOCF.||Units on a scale||Standard Deviation|Mean
811142|NCT01060150|Primary|Korean Version of the Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (K-ARS) Score|The K-ARS is a rating scale that is used for the ADHD diagnosis and the assessment of treatment efficacy and comprises 18 items in total on the basis of Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV), each item being rated from 0-3 points. The total score ranges from 0-54 with 0=normal and 54=severe condition.|Week 12|Intent-to-treat (ITT) population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Missing values at Week 12 were imputed using Last observation carried forward (LOCF).||Units on a scale||Standard Deviation|Mean
811143|NCT01060540|Secondary|Moderate Intensity Physical Activity|self-report based on the long version of the International Physical Activity Questionnaire. Moderate physical activity was queried in the domains of work (e.g., carrying light loads), transportation (e.g., bicycling), domestic chores and gardening (e.g., sweeping, raking), and leisure-time (e.g., bicycling, swimming).|3 months|||minutes per week||Standard Deviation|Mean
811144|NCT01060540|Secondary|Daily Caloric Intake|Estimated daily caloric intake based on self-reported frequency and amount of intake of specific foods over the past 3 months as assessed by the Block Brief Food Frequency Questionnaire|3 months|||kcal||Standard Deviation|Mean
811145|NCT01060540|Secondary|Perceived Lifetime Risk of Type 2 Diabetes|measured on 1-7 scale (definitely will not get diabetes to definitely will get diabetes)|3 months|||units on a scale||Standard Deviation|Mean
811146|NCT01060540|Secondary|Insulin Resistance (HOMA2-IR)|"Calculated using the updated homeostasis model assessment (HOMA) calculator at http://www.dtu.ox.ac.uk/homacalculator/
Higher numbers indicate higher insulin resistance. There are no established cutoffs indicating impaired resistance."|3 months|||units on a scale||Standard Deviation|Mean
811147|NCT01060540|Primary|Weight|weight 3 months post-enrollment|3 months|||kg||Standard Deviation|Mean
811148|NCT01060553|Secondary|Pittsburgh Sleep Index|subscales range from 0 to 3 with higher being worse.|baseline, 6 or 12 weeks (latest available is used)|due to very small numbers of completers in the acupuncture and the wait list control, the data from the wait list group who completed at least 6 weeks of treatment were combined with those initially assigned to treatment for a single group pre/post analysis||units on a scale||Standard Deviation|Mean
811149|NCT01060553|Primary|SF-36|global health functioning Mental component (MCS) and Physical component (PCS) subscales range from 0 to 100 with 100 being better; 50 is expected population average.|baseline, 6 or 12 weeks (latest available is used)|due to very small numbers of completers in the acupuncture and the wait list control, the data from the wait list group who completed at least 6 weeks of treatment were combined with those initially assigned to treatment for a single group pre/post analysis.||units on a scale||Standard Deviation|Mean
811150|NCT01060592|Primary|% Excess Weight Loss 12 Months After Surgery (Small Bands Only)||12m post surgery|||%EWL||Standard Deviation|Mean
811151|NCT01060592|Primary|% Excess Weight Loss 12 Months After Surgery (Large and Small Bands)||12m post surgery|||%EWL||Standard Deviation|Mean
811152|NCT01060592|Primary|%Excess Weight Loss 4-6 Weeks After Surgery (Small Bands Only)||4-6 weeks post surgery|||%EWL||Standard Deviation|Mean
811153|NCT01060592|Secondary|Number of Band Adjustments Required in the First Year After Surgery||12 months|||Number of Adjustments||Standard Deviation|Mean
811154|NCT01060592|Primary|%Excess Weight Loss 4-6 Weeks After Surgery (Large and Small Bands)||4-6 weeks post surgery|||%EWL||Standard Deviation|Mean
811155|NCT01060670|Secondary|Change in Short Form Health Survey (SF-36) Quality of Life Metrics|Short Form Health Survey (SF-36)- Quality of Life Metrics. The SF-36 was utilized and the Physical Function and Bodily Pain subscales were norm-based, with a Mean = 50, SD = 10. Scores could theoretically range from 0 to 100, with higher scores indicating a better health status.|Baseline and 16 weeks|ITT Population||units on a scale||Standard Deviation|Mean
811156|NCT01060670|Secondary|Incidence of Ulcer Recurrence|Measures the incidence of ulcer recurrence at the site of the study ulcer during the follow up phase.|12 weeks|ITT Population complete wound healed||participants|||Number
811157|NCT01060670|Secondary|Rate of Wound Closure|Rate of wound closure as assessed by computerized planimetry|16 weeks|ITT Population||percentage wound closure/week||Standard Deviation|Mean
811162|NCT01061008|Secondary|Forearm Muscle Cross Sectional Area||3 months||||||
811165|NCT01061008|Primary|Venous Diameter.|Measurements were made using duplex ultrasonagraphy. Measurements were made at predetermined distances 5 to 10 cm proximal to the anastomosis (dependent on wound dressings and turbulent flow around the anastomosis). The scanning position for each patient was traced using transparent sheets which allowed analogous measurement positions for all scans. Cross sectional vascular diameter measurements were made using conventional grey scale B Mode imaging. Diameters were measured from the inner edges of the vascular wall (Wiese & Nonnast-Daniel, 2004).|3 months|||mm||Standard Deviation|Mean
811166|NCT01061034|Secondary|Platelet Function Tests|"Platelet function tests were determined by optical whole blood aggregometry in response to arachidonic acid and adenosine diphosphate.
the results reflects the percent of active platelets."|on day 0 as a baseline and on day 7 and 21 of the study.|||percent||Standard Deviation|Mean
811167|NCT01061034|Primary|Aspirin Level in Blood (Area Under the Curve)|"Aspirins pharmacokinetics: aspirin blood level determined by use of high performance liquid chromatography (HPLC) at baseline, 1, 2,4,6,10 and 24 hours after administration of aspirin on day 7 and on day 21.
The area unther the time vs. concentration curve of the reccurent measurments(AUC) reflects bioavailability of aspirin."|on day 7,on day 21|9 volunteers completed the study, one volunteer was excluded from pharmacokinetics, because serum salicylic acid concentration was not at the baseline (non-detectable) in the 0-hour sample.||mg*hour/mL||Standard Deviation|Mean
811168|NCT01061177|Secondary|Percentage of Participants With Progression Free Survival in Participants Achieving MR4^0 at 12 Months|PFS was defined by the study protocol as the time from the date of start of study drug to the date of earliest progression to AP/BC, or the date of death from any cause.|12 months|The intent-to-treat (ITT) population consisted of all patients who received at least one dose of study drug.||Percentage of participants|||Number
811169|NCT01061177|Secondary|Rate of Molecular Response (MR4^5) by 18 Months|"MR4^5 was defined as either (i) detectable disease ≤ 0.0032% BCR-ABL ratio (IS) with mean ABL transcripts ≥ 32 000 or (ii) undetectable disease in cDNA with ≥ 32 000 ABL transcripts).
BCR = Breakpoint Cluster Region gene/BCR gene product
BCR-ABL is fusion gene formed from the ABL gene from chromosome 9 fusing with the BCR gene on chromosome 22, the gene product is BCR-ABL tyrosine kinase"|by 18 months|The ITT_MR population was a subset of the ITT population including the patients with typical BCR-ABL transcript at screening ie, b3a2 and/or b2a2 were considered.||Percentage of participants|||Number
811170|NCT01061177|Secondary|Rate of Molecular Response (MR4^0) by 18 Months|"MR4^0 was defined as either (i) detectable disease ≤ 0.01% BCR-ABL ratio (international scale (IS)) with mean ABL transcripts ≥ 10 000 or (ii) undetectable disease in complementary deoxyribonucleic acid (cDNA) with ≥ 10 000 ABL transcripts.
BCR = Breakpoint Cluster Region gene/BCR gene product
BCR-ABL is fusion gene formed from the ABL gene from chromosome 9 fusing with the BCR gene on chromosome 22, the gene product is BCR-ABL tyrosine kinase"|by 18 months|The ITT_MR population was a subset of the ITT population including the patients with typical BCR-ABL transcript at screening ie, b3a2 and/or b2a2 were considered. This population was referred to as ITT_MR.||Percentage of participants|||Number
811171|NCT01061177|Secondary|Percentage of Participants With Overall Survival at 12 and 24 Months|OS was defined as the time between the date of Day 1 (first treatment) and the date of death from any cause. Deaths which occurred after the 24-month time window and which were occasionally reported by some Investigators were excluded from the analysis. This is in agreement with the protocol stating that patients were to be followed for survival and progression to AP/BC up to 24 months after the participants treatment start.|12 months, 24 months|The intent-to-treat (ITT) population consisted of all patients who received at least one dose of study drug.||Percentage of participants|||Number
811172|NCT01061177|Secondary|Rate of Complete Hematologic Response (CHR) at, as Well as by, 12 and 24 Months|CHR was defined as all of the following present for ≥ 4 weeks in the peripheral blood: WBC count < 10 x 109/L, Platelet count < 450 x 109/L, No circulating peripheral blood blasts, promyelocytes, myelocytes, or metamyelocytes in the peripheral blood, The presence of < 5% basophils, No evidence of disease-related symptoms and extramedullary disease, including spleen and liver. Loss of CHR was defined as the appearance of any of the following after having achieved a CHR confirmed by a second determination ≥ 4 weeks later (unless associated with progression to AP/BC or death, which was considered to be a confirmed loss of CHR event on its own): WBC count that increased to > 20.0 x 109/L, Platelet count that increased to ≥ 600 x 109/L, Any palpable spleen, defined as size of spleen below costal margin > 5 cm, Appearance of > 5% myelocytes plus metamyelocytes, or any promyelocytes or blasts in the peripheral blood.|12 months, 24 months|The intent-to-treat (ITT) population consisted of all patients who received at least one dose of study drug.||Percentage of prticipants|||Number
811173|NCT01061177|Secondary|Rate of Molecular Response (MR4^5) at, as Well as by, 12 and 24 Months|MR4^5 was defined as either (i) detectable disease ≤ 0.0032% BCR-ABL ratio (IS) with mean ABL transcripts ≥ 32 000 or (ii) undetectable disease in cDNA with ≥ 32 000 ABL transcripts).|12 and 24 months|The ITT_MR population was a subset of the ITT population including the patients with typical BCR-ABL transcript at screening ie, b3a2 and/or b2a2 were considered.||Percentage of participants|||Number
811174|NCT01061177|Secondary|Rate of Molecular Response (MR4^0) at, as Well as by, 12 and 24 Months|MR4^0 was defined as either (i) detectable disease ≤ 0.01% BCR-ABL ratio (international scale (IS)) with mean ABL transcripts ≥ 10 000 or (ii) undetectable disease in complementary deoxyribonucleic acid (cDNA) with ≥ 10 000 ABL transcripts.|12 and 24 months|The ITT_MR population was a subset of the ITT population including the patients with typical BCR-ABL transcript at screening ie, b3a2 and/or b2a2 were considered. This population was referred to as ITT_MR.||Percentage of participants|||Number
811175|NCT01061177|Secondary|Percentage of Participants With Progression Free Survival (PFS) at 12 and 24 Months|PFS was defined by the study protocol as the time from the date of start of study drug to the date of earliest progression to AP/BC, or the date of death from any cause.|12 months, 24 months|The intent-to-treat (ITT) population consisted of all patients who received at least one dose of study drug.||Percentage of participants|||Number
811176|NCT01061177|Secondary|Percentage of Participants With Event Free Survival in Participants Achieving MR4^0 at 12 Months|EFS was defined as the time from the date of Day 1 (first treatment) + 1 day to the first occurrence of any of the following: Loss of complete hematologic response (CHR), Loss of CCyR, Death from any cause, Progression to the AP or BC of CML, Not achieving CHR up to 3 months (i.e. 91 + 15 days).|at 12 months|The intent-to-treat (ITT) population consisted of all patients who received at least one dose of study drug.||Percentage of participants|||Number
811177|NCT01061177|Secondary|Percentage of Participants Free From Progression to AP/BC With MR4^0 at 12 Months|"The following events were considered disease progression to AP/BC: Death due to disease under study; AP, as defined by any of the following: ≥ 15% blasts in the peripheral blood or bone marrow, but < 30% blasts in both the peripheral blood and bone marrow, ≥ 30% blasts plus promyelocytes in peripheral blood or bone marrow, ≥ 20% basophils in the peripheral blood, Thrombocytopenia (< 100 × 109/L) that was unrelated to therapy, Evidence of clonal evolution, as determined by medical review with consensus of the SSMC/DMC.
BC was defined as: ≥ 30% blasts in peripheral blood or bone marrow, Appearance of extramedullary involvement other than hepatosplenomegaly proven by biopsy."|at 12 months|The intent-to-treat (ITT) population consisted of all patients who received at least one dose of study drug.||Percentage of participants|||Number
811178|NCT01061177|Secondary|Percentage of Participants With Major Cytogenetic Response (MCyR) at, as Well as by, 12 and 24 Months|Major cytogenetic response (MCyR) parameters were defined as 0 to 35% Philadelphia positive (Ph+) metaphases.|12 and 24 months|The ITT_CyR population was a subset of the ITT population including the Ph+ patients at screening was considered. Patients who had either no metaphases recorded at screening bone marrow or only negative metaphases recorded at screening bone marrow but had Ph+ metaphases at any visits after screening were also part of this population.||Percentage of participants|||Number
811179|NCT01061177|Secondary|Percentage of Participants With Complete Cytogenetic Response (CCyR) at, as Well as by, 12 and 24 Months|CCyR parameters were defined as 0% Philadelphia positive (Ph+) metaphases. Loss of CCyR was defined as a patient exceeding the CCyR criteria (ie, > 0% Ph+ metaphases) at a subsequent visit after the patient had achieved CCyR.|12 and 24 months|The ITT_CyR population was a subset of the ITT population including the Ph+ patients at screening was considered. Patients who had either no metaphases recorded at screening bone marrow or only negative metaphases recorded at screening bone marrow but had Ph+ metaphases at any visits after screening were also part of this population.||Percentage of participants|||Number
811180|NCT01061177|Secondary|Percentage of Participants With Major Molecular Response (MMR) at, as Well as by, 12 and 24 Months|"MMR was defined as BCR-ABL ratio (IS) ≤ 0.1% in a peripheral blood sample. BCR-ABL1 is an abnormal gene found in chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL). The chromosomal defect in the Philadelphia chromosome is a translocation, in which parts of two chromosomes, 9 and 22, swap places. The result is that a fusion gene is created by juxtapositioning the Abl1 gene on chromosome 9 to a part of the BCR (breakpoint cluster region) gene on chromosome 22. Depending upon the breakpoints on the BCR gene, there are several forms of fusion proteins."|12 months, 24 months|Intent-to-treat_Molecular (ITT_MR) analysis set was a subset of the ITT population including the patients with typical BCR-ABL transcript at screening.||Percentage of participants|||Number
811181|NCT01061177|Secondary|Rate of Event Free Survival at 12 and 24 Months|EFS was defined as the time from the date of Day 1 (first treatment) + 1 day to the first occurrence of any of the following: Loss of complete hematologic response (CHR), Loss of CCyR, Death from any cause, Progression to the AP or BC of CML, Not achieving CHR up to 3 months (ie, 91 + 15 days), Not achieving CCyR up to 18 months (ie, 548 + 15 days), whichever is earlier.|at 12 and 24 months|The intent-to-treat (ITT) population consisted of all patients who received at least one dose of study drug.||Percentage of participants|||Number
811182|NCT01061177|Secondary|Percentage of Participants Free From Progression to Accelerated Phase/Blast Crisis (AP/BC) at 12 and 24 Months|"The following events were considered disease progression to AP/BC: Death due to disease under study; AP, as defined by any of the following: ≥ 15% blasts in the peripheral blood or bone marrow, but < 30% blasts in both the peripheral blood and bone marrow, ≥ 30% blasts plus promyelocytes in peripheral blood or bone marrow, ≥ 20% basophils in the peripheral blood, Thrombocytopenia (< 100 × 109/L) that was unrelated to therapy, Evidence of clonal evolution, as determined by medical review with consensus of the SSMC/DMC.
BC was defined as: ≥ 30% blasts in peripheral blood or bone marrow, Appearance of extramedullary involvement other than hepatosplenomegaly proven by biopsy."|at 12 and 24 months|The intent-to-treat (ITT) population consisted of all patients who received at least one dose of study drug.||Percentage of participants|||Number
811183|NCT01061177|Primary|Percentage of Participants With Molecular Response (MR4^0) at 18 Months|MR4^0 was defined as either (i) detectable disease ≤ 0.01% BCR-ABL ratio (international scale (IS)) with mean ABL transcripts ≥ 10 000 or (ii) undetectable disease in complementary deoxyribonucleic acid (cDNA) with ≥ 10 000 ABL transcripts.|at 18 months|Intent-to-treat_Molecular (ITT_MR) analysis set was a subset of the ITT population including the patients with typical BCR-ABL transcript at screening.||Percentage of Participants|||Number
811184|NCT01061333|Secondary|Allergen-induced Concentrations of Sputum LTE4|Concentrations of LTE4 in sputum at 2 hours post-allergen challenge|2 hours post allergen challenge|Pre-imputation status. Missing data points were excluded and values below the lower limit of quantification (LLOQ) were included in the analysis with an assigned value of assay LLOQ.||pg/mL||Standard Deviation|Geometric Mean
811185|NCT01061333|Secondary|Allergen-induced Concentrations of Sputum LTD4|Concentrations of LTD4 in sputum at 2 hours post-allergen challenge|2 hours post allergen challenge|Pre-imputation status. Missing data points were excluded and values below the lower limit of quantification (LLOQ) were included in the analysis with an assigned value of assay LLOQ.||pg/mL||Standard Deviation|Geometric Mean
811186|NCT01061333|Secondary|Allergen-induced Concentrations of Sputum LTC4|Concentrations of LTC4 in sputum at 2 hours post-allergen challenge|2 hours post allergen challenge|Pre-imputation status. Missing data points were excluded and values below the lower limit of quantification (LLOQ) were included in the analysis with an assigned value of assay LLOQ.||pg/mL||Standard Deviation|Geometric Mean
811187|NCT01061333|Secondary|Allergen-induced Changes in Urinary Leukotriene (LT) E4|Fold change over baseline in urinary LTE4 at 2 hours post-allergen challenge|Baseline and 2 hours post allergen challenge|Only participants with baseline values were analyzed||Fold change over baseline||Standard Deviation|Geometric Mean
811188|NCT01061333|Secondary|Allergen-induced Changes in Urinary 9P|Fold change over baseline in Urinary 9P at 2 hours post allergen challenge|Baseline and 2 hours post allergen challenge|Only participants with baseline values were analyzed||Fold change over baseline||Standard Deviation|Geometric Mean
811189|NCT01061333|Primary|Change in Plasma 9P at 20 Minutes|Fold change over baseline of plasma 9P at 20 minutes post-allergen challenge|Pre-allergen challenge and 20 minutes post allergen challenge|||Fold change over baseline||Standard Deviation|Geometric Mean
831854|NCT01243320|Primary|Change In Glucose Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days|||mg/dL||95% Confidence Interval|Mean
811190|NCT01061333|Primary|Change in Plasma 9α-11β-PGF2 (9P) at 5 Minutes|Fold change over baseline of plasma 9P at 5 minutes post-allergen challenge|Pre-allergen challenge and 5 minutes post allergen challenge|||Fold change over baseline||Standard Deviation|Geometric Mean
811191|NCT01061333|Primary|Change in Forced Expiratory Volume in 1 Second (FEV1)|Maximal percent drop in FEV1 at 20 minutes post allergen challenge|Pre-allergen challenge and 20 minutes after allergen challenge|||Percentage drop in FEV1||Standard Deviation|Least Squares Mean
811192|NCT01061359|Secondary|Time to Recurrence (DFI)||3m, 6m, 9m, 1y, 1.5y, 2y, 2.5y, 3y, 3.5y, 4y, 4.5y, 5y|Median time to recurrence was not reached.||months||Full Range|Median
811193|NCT01061359|Secondary|Time to Progression (TTP)||3m, 6m, 9m, 1y, 1.5y, 2y, 2.5y, 3y, 3.5y, 4y, 4.5y, 5y|16.3% of patients had experienced disease progression by the end of the study. As this is less than 50% the median time to progression is not defined.||months||Full Range|Median
811194|NCT01061359|Primary|Percentage of Participants With Disease Free Survival (DFS)|Percentage of participants with DFS who completed 5 year follow-up visit.|3m, 6m, 9m, 1y, 1.5y, 2y, 2.5y, 3y, 3.5y, 4y, 4.5y, 5y|Intent to treat (ITT)||Percentage of participants|||Number
811195|NCT01061385|Secondary|Percentage of Subjects With >=25% Excess Weight Loss (EWL)|a between-group comparison of percentage of treatment subjects achieving >=25% EWL (using the Metropolitan Life Tables (ML) method) compared to the percentage of control group subjects achieving >= 25%EWL at 12 months|12 months|||percentage of subjects|||Number
811196|NCT01061385|Primary|%Excess Weight Loss|the difference between the %EWL between treatment and control groups must be clinically significant|36 Weeks|||percent excess weight loss||Standard Deviation|Mean
811197|NCT01061476|Primary|Change in AHI|The primary outcome was the change in the apnea hypopnea index (AHI). Sleep apnea events are defined as apneas and hypopneas.The AHI is a measure of sleep apnea severity. An AHI > 5 event/h is considered abnormal. AHI values are typically categorized as 5-15 events/hr = mild; 15-30 events/hr = moderate; and > 30 events/hr = severe. For this study we compared the change in AHI from the baseline sleep study (No Provent) compared to the treatment night sleep study (on Provent).|Comparisons were made between the 2 nights|Although all participants went through the sleep studies, there was insufficient data in 1 subject to assess sleep apnea severity and was therefore excluded from analysis.||events/h||Standard Deviation|Mean
811198|NCT01061567|Secondary|Change From Baseline in Morisky Medication Adherence Scale (MMAS) 4 Item Score|The Morisky Medication Adherence Scale with 4 items was administered to examine medication adherence. The score ranges from 0 (best adherence) to 4 (worst adherence). The change was calculated by the value at baseline minus the value at visit 3. Therefore, a change >0 reflects an improvement|Baseline and the end of study (up to 16 weeks)|Patients from FAS with evaluable data in the Morisky scale for baseline and at visit 3.||units on a scale||Standard Deviation|Mean
811199|NCT01061567|Secondary|Change From Baseline in Visual Analogue Scale (VAS) of Patient Satisfaction|The visual analogue scale measures overall patient satisfaction with treatment on a continuous axis ranging from 0 (no satisfaction) to 100 (highest patient satisfaction). The change was calculated by the value at the final visit minus the value at baseline. Therefore, an increase (change>0) reflects an improvement in patient satisfaction.|Baseline and the end of study (up to 16 weeks)|Patients from FAS with evaluable data in VAS at baseline and at visit 3.||units on a scale||Standard Deviation|Mean
811200|NCT01061567|Secondary|Clinical Global Impression of Improvement (CGI-I) Responder Rate|The CGI-I was rated (from 1: very much improved, to 7: very much worse) to assess the overall status of Parkinson’s disease. The clinician rated how much a patient’s condition had improved or worsened relative to baseline state. The patients are considered to be a CGI-I responder if they are rated at least by minimally improved.|Baseline and the end of study (up to 16 weeks)|Patients from FAS||percentage of participants|||Number
811201|NCT01061567|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts I and III Total Score|Mentation, behaviour and mood is scored from 0-16 in UPDRS I (0 = best score to 16 = worst score), result of motor examination scored from 0-108 in UPDRS III (0=no disability, 108=maximum disability) . The change was calculated by Baseline value minus value at visit 3. A decrease (change>0) in the score means improvement.|Baseline and the end of study (up to 16 weeks)|Patients from the Full Analysis Set (FAS) which includes all treated patients who have data for at least one post baseline visit.||units on a scale||Standard Deviation|Mean
811202|NCT01061567|Primary|Proportion of Patients With Withdrawals Due to Adverse Events.|Patients who discontinued treatment due to adverse events including deaths.|16 weeks|Patients from the Treated Set (TS).||proportion of participants|||Number
811203|NCT01061567|Primary|Incidence of Adverse Events|The number of patients with any adverse events (AEs), patients with drug-related AEs.|From the treatment initiation to the end of study, on average 92.9 days|Patients from the Treated Set (TS).||participants|||Number
811204|NCT01061606|Secondary|Time to Progression||Time to progression is defined as the time from registration to disease progression.|The study concluded terminated early and patients were not followed.|||||
811205|NCT01061606|Secondary|Time to Treatment Failure|Time to treatment failure will be evaluated using the method of Kaplan-Meier.|From study registration to the date patients end treatment, assessed up to 3 years|The study concluded terminated early and patients were not followed.|||||
811206|NCT01061606|Secondary|Duration of Response, Defined for All Evaluable Patients Who Have Achieved an Objective Response as the Date at Which the Patient’s Objective Status is First Noted to be Either a CR or PR to the Date Progression is Documented|Median duration of response and the confidence interval for the median duration will be computed.|Up to 3 years|The study concluded terminated early and patients were not followed.|||||
811207|NCT01061606|Secondary|Overall Survival|Time to event distributions will be estimated using the Kaplan-Meier method.|From registration to death, assessed up to 3 years|The study concluded terminated early and patients were not followed.|||||
811208|NCT01061606|Primary|Progression Free Survival|The 6-month progression-free rate is defined as the total number of efficacy-evaluable patients on study without documentation of disease progression 6 months from registration divided by the total number of efficacy-evaluable patients enrolled on study.|6 months from registration|The study concluded terminated early and patients were not followed.|||||
811209|NCT01061606|Primary|Tumor Response Rate, in Terms of the Proportion of Confirmed Tumor Responses (CR or PR) Assessed Using RECIST||Up to 3 years|||participants|||Number
811218|NCT01061710|Secondary|Number of Participants With Risk Factors Likely to Affect the Proportion of Responders||24 weeks|The efficacy analysis population comprised the participants who had at least one post-baseline efficacy measurement among the safety analysis population. Because of the small population size, no risk analyses were performed.|||||
811219|NCT01061710|Secondary|Number of Participants With Risk Factors Likely to Affect the Frequency of Treatment-Related Adverse Events (AEs)||24 weeks|The safety analysis population comprised participants who had been enrolled in varenicline protocol A3051109 and retreated with varenicline within 52 weeks of initial treatment. Because of the small population size, no risk analyses were performed.|||||
811220|NCT01061710|Secondary|Number of Treatment-Related Adverse Events (AEs) Unlisted in Japanese Package Insert|An AE was any untoward medical occurrence attributed to varenicline in a participant who received varenicline. Treatment related adverse events were evaluated in company with the causal relationship to veranicline.|24 weeks|The safety analysis population comprised participants who had been enrolled in varenicline protocol A3051109 and retreated with varenicline within 52 weeks of initial treatment.||Participants|||Number
811221|NCT01061710|Primary|Number of Responders to Varenicline Treatment|Number of participants who succeeded in smoking cessation from 12 weeks through 24 weeks of the observation period.|24 weeks|The efficacy analysis population comprised the participants who had at least one post-baseline efficacy measurement among the safety analysis population.||Participants|||Number
811222|NCT01061710|Primary|Number of Participants With Treatment-Related Adverse Events (AEs)|An AE was any untoward medical occurrence attributed to veranicline in a participant who received veranicline. Treatment related adverse events were evaluated in company with the causal relationship to veranicline.|24 weeks|The safety analysis population comprised participants who had been enrolled in varenicline protocol A3051109 and retreated with varenicline within 52 weeks of initial treatment.||Participants|||Number
811223|NCT01061723|Secondary|Change From Baseline in ASAS Individual Components at Week 12|ASAS consists of 4 individual components: Participant global assessment to assess the disease activity over the last week on a 0 (no pain) - 10 (severe pain) NRS; back pain which consist of the mean of the nocturnal back pain and the total back pain at every visit on a 0 (no pain) - 10 (most severe pain) NRS; inflammation measured as the mean of the last 2 BASDAI questions (intensity and duration of morning stiffness) and physical function measured as mean of 10 scores of BASFI at every visit on 0 (easy) -10 (impossible) NRS. Lower score corresponds to a better functioning.|Baseline, Week 12 (LOCF)|ITT population. Missing data was imputed using LOCF. Number of participants analyzed = participants with ASAS assessment at specified time-points.||units on a scale||Standard Deviation|Mean
811224|NCT01061723|Secondary|Change From Baseline in Hs-CRP at Week 12|Participant's blood samples were collected at screening, baseline before dosing and at every visit to evaluate the level of hs-CRP. The hs-CRP is a protein marker in the blood associated with inflammation with higher values indicating a greater degree of inflammation.|Baseline, Week 12 (LOCF)|ITT population. Missing data was imputed using LOCF. Number of participants analyzed = participants with Hs-CRP assessment at specified time-points.||mg/dL||Standard Deviation|Mean
811225|NCT01061723|Secondary|Change From Baseline in Swollen Joint Index at Week 12|44 swollen joints were examined including sternal, clavicular, elbow, shoulder, wrist, knee, metacarpophalangian, interphalangian, metatarpophalangian and metatarsophalangeal joints.|Baseline, Week 12 (LOCF)|ITT population. Missing data was imputed using LOCF. Number of participants analyzed = participants with swollen joint count assessment at specified time-points.||Joints||Standard Deviation|Mean
811226|NCT01061723|Secondary|Change From Baseline in Chest Expansion at Week 12|The difference between maximal inspiration and expiration to the nearest 0.1 cm was recorded. The best of 2 tries were recorded.|Baseline, Week 12 (LOCF)|ITT population. Missing data was imputed using LOCF. Number of participants analyzed = participants with chest expansion assessment at specified time-points.||cm||Standard Deviation|Mean
811227|NCT01061723|Secondary|Percentage of Participants Who Achieved ASAS 5/6 Improvement Criteria at Week 12|ASAS 5/6 responder had an improvement of 20% in 5 of 6 domains (physical function, back pain, participant global assessment, inflammation, spinal mobility and acute phase reactants) of ASAS-IC without deterioration in the 6th domain. Spinal mobility was assessed by the mean of the 5 BASMI scores on the 11-point scale (score ranges from 0-10) and the hs-CRP for the acute phase reactant.|Baseline to Week 12 (LOCF)|ITT population. Missing data was imputed using LOCF.||percentage of participants|||Number
811228|NCT01061723|Secondary|Change From Baseline in Magnetic Resonance Imaging (MRI) Score of the Spine Assessed by the Berlin Modification of the AS Spine MRI-active (ASspiMRI-a) Score at Week 12|ASspiMRI-a scoring system was used on all MRIs to score the level of the disease. MRIs were obtained using 1.0 or 1.5 Tesla scanners and phased array coils. Sagittal images of the upper (C2 to T10) and lower (T8 to S1) spine were used using both T1 weighted spin echo and fat saturated Short Tau Inversion Recovery (STIR) sequences. Each vertebral body unit was given an activity score based on the amount of bone marrow edema or erosion. Both T1 and STIR sequences were analyzed for change. Total spine ASspiMRI-a score in the Berlin modification range from 0 to 69 with higher scores indicating higher disease activity. A negative value in total spine ASspiMRI-a score change from baseline indicates an improvement from baseline. The higher the negative value the higher the reduction of inflammation.|Baseline, Week 12|ITT population. Number of participants analyzed = participants with ASspiMRI-a assessment at specified time-points.||units on a scale||Standard Deviation|Mean
811229|NCT01061723|Secondary|Change From Baseline in Range of Motion Assessed by the Bath AS Metrology Index (BASMI) at Week 12|The range of motion was measured by the BASMI (11-point scale) including chest expansion in cm. It composed of 5 clinical measurements associated with a score: tragus to wall distance, modified schober’s test, lateral spinal flexion, intermalleolar distance and cervical rotation. BASMI score was calculated by dividing the total of the score by 5, and the score ranges from 0-10. Higher BASMI score indicates more severe limitation of movement.|Baseline, Week 12 (LOCF)|ITT population. Missing data was imputed using LOCF. Number of participants analyzed=participants with BASMI score assessment at specified time-points.||units on a scale||Standard Deviation|Mean
811265|NCT01062256|Secondary|Number of Cough Bouts Within Each 15-minute Time Interval Postdose|Cough bouts defined as one or several cough sounds occurring after one inspiration (one explosive bout between inspiration and expiration). Audio recordings made of participants during 4-hour (240-minute) period after dosing. Based on audio recordings, a trained cough counter counted and recorded the number of cough bouts in 15 minute intervals.|every 15 minutes postdose up to 240 minutes postdose|ITT||cough bouts||Standard Deviation|Mean
811230|NCT01061723|Secondary|Change From Baseline in BASDAI Score at Week 12|BASDAI comprises of a 0 (no pain) -10 (very severe pain) NRS, used to answer 6 questions (Q) related to symptoms of AS (fatigue/tiredness, neck, back or hip pain, pain / swelling in joints, discomfort in tender areas, morning stiffness duration and morning stiffness severity). The BASDAI total score was calculated by computing the mean of Q5 and Q6 and adding it to the sum of Q1 to Q4. This score was then divided by 5. BASDAI total score=Q1+Q2+Q3+Q4+[Q5+Q6/2]/5. The total BASDAI score ranges from 0=none to 10=severe, where lower score indicated less disease activity.|Baseline, Week 12 (LOCF)|ITT population. Missing data was imputed using LOCF. Number of participants analyzed = participants with BASDAI score assessment at specified time-points.||units on a scale||Standard Deviation|Mean
811231|NCT01061723|Secondary|Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 12|ASDAS consists of five components: (Total back pain assessed by BASDAI question 2 on a 0 [no pain] - 10 [most severe pain] NRS, participant global of disease activity on a 0 [none] – 10 [severe] NRS, peripheral pain/swelling assessed by BASDAI question 3 on a 0 [none] - 10 [most severe pain] NRS, duration of morning stiffness assessed by BASDAI question 6 on a NRS from 0 [0 hour] - 10 [2 or more hours] and hs-CRP in mg/L). ASDAS score was calculated as follows: 0.121 x total back pain + 0.110 x participant global of disease activity + 0.073 x peripheral pain/swelling + 0.058 x duration of morning stiffness + 0.579 x ln(CRP + 1). The scores were categorized as: inactive disease (< 1.3), moderate (1.3 - < 2.1), high (2.1 - 3.5) and very high disease activity (> 3.5).|Baseline, Week 12 (LOCF)|ITT population. Missing data was imputed using LOCF. Number of participants analyzed = participants with ASDAS score assessment at specified time-points.||units on a scale||Standard Deviation|Mean
811232|NCT01061723|Secondary|Percentage of Participants Who Achieved Partial Remission According to the Assessment in AS Working Group Criteria for Response (ASAS) at Week 12|Participants were classified as having achieved ASAS partial remission if they had a value ≤ 2 units on a 0 -10 NRS in each of the 4 domains: (participant global assessment, back pain, physical function and inflammation) of the ASAS-IC.|Baseline to Week 12 (LOCF)|ITT population. Missing data was imputed using LOCF.||percentage of participants|||Number
811233|NCT01061723|Secondary|Percentage of Participants Who Achieved 40% Response According to the Assessment in AS Working Group Criteria for Response (ASAS40) at Week 12|Clinical response to treatment for ASAS40 was assessed according to ASAS40 criteria. Treatment response for ASAS40 was defined as an improvement by a decrease of ≥40% and ≥2 units on a 0 (no pain)-10 (most severe pain) NRS in at least 3 of the 4 ASAS-IC domains (participant global assessment, back pain, physical function and inflammation) and no worsening (increase in score) at all in the remaining 4th domain.|Baseline to Week 12 (LOCF)|ITT population. Missing data was imputed using LOCF.||percentage of participants|||Number
811234|NCT01061723|Primary|Percentage of Participants Who Achieved 20% Response According to the Assessment in Ankylosing Spondylitis (AS) Working Group Criteria for Response (ASAS20) at Week 12|Clinical response to treatment for ASAS20 was assessed according to ASAS20 criteria. Treatment response for ASAS20 was defined as an improvement by a decrease of ≥20% and ≥1unit on a 0 (no pain) - 10 (most severe pain) numerical rating scale (NRS) in at least 3 of the 4 ASAS improvement criteria (ASAS-IC) domains: assessment of physical function (measured by Bath Ankylosing Spondylitis Functional Index [BASFI]), back pain (0-10 NRS), participant global assessment (0-10 NRS) and inflammation (measured as the mean of the last 2 Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] questions) and no worsening (increase in score) of ≥20% and ≥1 unit on a 0-10 NRS in the remaining 4th domain.|Baseline to Week 12 (Last Observation Carried Forward [LOCF])|Intent-to-treat (ITT) population included all randomized participants. Missing data was imputed using LOCF.||percentage of participants|||Number
811235|NCT01061736|Secondary|Part B: Percentage of Participants Achieving a Major Clinical Response at Week 52|Major clinical response was defined as an ACR70 response maintained for at least 24 consecutive weeks. ACR70 response uses the same criteria as for ACR20 but requires 70% improvement. In the primary approach, data collected after treatment discontinuation or rescue was set to missing. No imputation of missing post-baseline values was performed. Responder status was determined if possible. With these rules, participants automatically became non-responders for all time points beyond the time point they started rescue treatment or discontinued study treatment.|Baseline up to Week 52|ITT population which included all participants randomized after dose selection (cohort 2).||Percentage of participants|||Number
811236|NCT01061736|Primary|Part B: Change From Baseline in Van Der Heijde Modified Total Sharp Score (mTSS) at Week 52|The Sharp method modified by D. van der Heijde involves separate scores for erosions and joint space narrowing based on radiographs to assess the degree of structural damage. Total score range from 0 (normal) to 448 (worst possible total score). An increase in total score represents progression of structural damage. Missing data were imputed by the linear extrapolation method.|Baseline, Week 52|Cohort 2 ITT population and included participants with available data of mTSS at baseline and on or before Week 52.||units on a scale||Standard Deviation|Mean
811237|NCT01061736|Primary|Part B: Change From Baseline in Health Assessment Question Disability Index (HAQ-DI) at Week 16|HAQ-DI was a participant-reported questionnaire that assesses the difficulty of performing daily activities: dress/groom, arise, eat, walk, reach, grip, hygiene and common activities. Overall score range from 0=least difficulty to 3=extreme difficulty. An increase in the score indicates a worsening of physical function while a decrease in the score represents improvement. Data collected after treatment discontinuation was set to missing.|Baseline, Week 16|Cohort 2 ITT population only and included participants with available data of HAQ-DI at baseline and on or before Week 16.||units on a scale||Standard Deviation|Mean
811238|NCT01061736|Primary|Part B: Percentage of Participants Achieving ACR20 Response at Week 24|ACR20 improvement responses were determined without imputation of missing post-baseline values. In addition data collected after treatment discontinuation or rescue was set to missing. Responder status was determined if possible. With these rules, participants automatically became non-responders for all time points beyond the time point they started rescue treatment or discontinued study treatment.|Baseline to Week 24|ITT population which included all participants randomized after dose selection (cohort 2).||Percentage of participants|||Number
811266|NCT01062256|Secondary|Number of Cough Bouts Over 2-hour Postdose Period|Cough bouts defined as one or several cough sounds occurring after one inspiration (one explosive bout between inspiration and expiration). Audio recordings made of participants during first 2 hours postdose. Based on audio recordings, a trained cough counter counted and recorded the number of cough bouts.|0 to 2 hours postdose|ITT||cough bouts||Standard Deviation|Mean
811239|NCT01061736|Primary|Part A: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12|ACR20 response was defined, based on guidelines set forth by the American College of Rheumatology (ACR), as ≥20 % improvement in tender joint count and swollen joint count as well as ≥20% improvement in at least 3 of 5 following measures: C-Reactive Protein (CRP), Participant assessment of pain; Participant's global assessment of disease activity; Physician global assessment of disease activity; and Health Assessment Question-Disability Index (HAQ-DI). Missing data imputed by Last Observation Carried Forward (LOCF).|Baseline to Week 12|Part A Intent-to-treat (ITT) population defined as all randomized participants.||Percentage of participants|||Number
811240|NCT01061775|Secondary|Calorie Intake Based on 3-day Diet Records|Dietary data were collected via 3-day diet records (Crawford et al. 1994) twice during the study, at baseline and week 24. Three-day diet records were collected on consecutive days including one weekend day. A registered dietitian (RD) instructed subjects on dietary data collection at baseline appointment. Depending on the age and capacity of the subject, the patient, parent or a collaboration of both recorded dietary intake. A RD entered dietary data into Nutritionist Pro software (First DataBank, SanBruno, CA) and the mean difference was analyzed.|24 weeks|The sample size was small due to missing data||kcals||95% Confidence Interval|Mean
811241|NCT01061775|Secondary|Childhood Eating Behavior Questionnaire (CEBQ)|The Child Eating Behaviour Questionnaire (CEBQ) was designed as parent-report measure comprised of 35 items, each rated on a five-point likert scale that ranges from never to always. We utilized the CEBQ as a self-report measure during this study; it has not been validated for such use. For the purposes of this study, we looked at the Satiety Responsiveness Subscale Scores (5 questions; total scores could range from 5-25 with lower scores denoting a lower level of satiety). The results reported show the change between baseline and week 24 scores.|24 weeks|Paired t-tests were performed to compare the satiety survey (continuous). Three subjects discontinued prior to completing the Week 24 CEBQ.||units on a scale||95% Confidence Interval|Mean
811242|NCT01061775|Primary|Waist to Height Ratio (WHtR)|Waist circumference was measured at the natural waist level (midway between the lowest rib margin and the iliac crest) at baseline and 24 weeks|24 weeks|All analyses were performed using SPSS (version 20.0.0, SPSS Inc, Chicago, IL).||percentage||Standard Deviation|Mean
811243|NCT01061775|Primary|BMI Change|BMI was collected at baseline and 24 weeks|24 weeks|The effects of exenatide on BMI were analyzed using a paired t-test comparing BMI at baseline with BMI after six months of treatment with each patient serving as his or her own control.||kg/m^2||95% Confidence Interval|Mean
811244|NCT01061866|Primary|Change From Baseline in the Mean Number of Daily Seizures at 1 Year.||Baseline 3 months and 1 year of treatment|males of 25 years old mean with refractory epilepsy, antiepileptic treatment and electroencephalographic study||Number of Seizures||Standard Error|Mean
811245|NCT01062061|Primary|Percentage of Participants With One or More Unexpected SAEs|Unexpected SAEs differed from SAEs reported in the VARIVAX product label with regard to their identity, severity, specificity, or outcome|Up to 42 days after vaccination|||percentage of participants|||Number
811246|NCT01062061|Primary|Percentage of Participants With One or More Serious ADRs|A serious ADR is an SAE (defined above) for which relatedness to the use of the product cannot be ruled out|Up to 42 days after vaccination|Serious ADRs were reported for participants in the safety population: participants administered VARIVAX in usual practice and not discontinued for a reason given in the Participant Flow||percentage of participants|||Number
811247|NCT01062061|Primary|Percentage of Participants With One or More Serious Adverse Events (SAEs)|An SAE is any AE that results in death, is life-threatening, results in persistent or significant disability/incapacity, results in or prolongs an existing inpatient hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is another important medical event based on appropriate medical judgment.|Up to 42 days after vaccination|SAEs were reported for participants in the safety population: participants administered VARIVAX in usual practice and not discontinued for a reason given in the Participant Flow||percentage of participants|||Number
811248|NCT01062061|Primary|Percentage of Participants With One or More Unexpected ADRs|An unexpected ADR is an unexpected AE (defined above) for which relatedness to the use of the study vaccine cannot be ruled out|Up to 42 days after vaccination|Unexpected ADRs were reported for participants in the safety population: participants administered VARIVAX in usual practice and not discontinued for a reason given in the Participant Flow||percentage of participants|||Number
811249|NCT01062061|Primary|Percentage of Participants With One or More Unexpected AEs|Unexpected AEs differed from AEs reported in the VARIVAX product label with regard to their identity, severity, specificity, or outcome|Up to 42 days after vaccination|Unexpected AEs were reported for participants in the safety population: participants administered VARIVAX in usual practice and not discontinued for a reason given in the Participant Flow||percentage of participants|||Number
811250|NCT01062061|Primary|Percentage of Participants With One or More Adverse Drug Reactions (ADRs)|An ADR is an AE (defined above) for which relatedness to the use of the product cannot be ruled out|Up to 42 days after vaccination|ADRs were reported for participants in the safety population: participants administered VARIVAX in usual practice and not discontinued for a reason given in the Participant Flow||percentage of participants|||Number
811251|NCT01062061|Primary|Percentage of Participants With One or More AEs by Age|"An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study vaccine, is also an adverse event.
Changes resulting from normal growth and development which do not vary significantly in frequency or severity from expected levels are not to be considered adverse events. Examples of this may include, but are not limited to, teething, typical crying in infants and children, and onset of menses or menopause occurring at a physiologically appropriate time."|Up to 42 days after vaccination|AEs were reported for participants in the safety population: participants administered VARIVAX in usual practice and not discontinued for a reason given in the Participant Flow||percentage of participants|||Number
811280|NCT01054976|Primary|Change From Baseline in Simple Reaction Time|The Simple Reaction Time is a computerized attention test that evaluates the patient’s reaction time when the color of the computer screen changes from black to white by performing a total of 70 times for six minutes.|Baseline, Week 12|Per-protocol (PP) analysis set.||seconds||Standard Deviation|Mean
811252|NCT01062061|Primary|Percentage of Participants With One or More AEs by Gender|"An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study vaccine, is also an adverse event.
Changes resulting from normal growth and development which do not vary significantly in frequency or severity from expected levels are not to be considered adverse events. Examples of this may include, but are not limited to, teething, typical crying in infants and children, and onset of menses or menopause occurring at a physiologically appropriate time."|Up to 42 days after vaccination|AEs were reported for participants in the safety population: participants administered VARIVAX in usual practice and not discontinued for a reason given in the Participant Flow||percentage of participants|||Number
811253|NCT01062061|Primary|Percentage of Participants With One or More Adverse Events (AEs)|"An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study vaccine, is also an adverse event.
Changes resulting from normal growth and development which do not vary significantly in frequency or severity from expected levels are not to be considered adverse events. Examples of this may include, but are not limited to, teething, typical crying in infants and children, and onset of menses or menopause occurring at a physiologically appropriate time."|Up to 42 days after vaccination|Adverse events were reported for participants in the safety population: participants administered VARIVAX in usual practice and not discontinued for a reason given in the Participant Flow||Percentage of Participants|||Number
811254|NCT01062074|Primary|Percentage of Participants With Any Adverse Drug Reaction|An adverse drug reaction was an adverse experience for which a causal relationship to the study drug could not be ruled out|Up to 14 days after any GARDASIL vaccination|Participants who received at least 1 vaccination with GARDASIL, had Case Report Forms available, and did not violate the protocol||Percent of participants|||Number
811255|NCT01062074|Primary|Percentage of Participants With Any Adverse Experience|An adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse experience.|Up to 14 days after any GARDASIL vaccination|Participants who received at least 1 vaccination with GARDASIL, had Case Report Forms available, and did not violate the protocol||Percent of participants|||Number
811256|NCT01062113|Secondary|Differences in Pain Intensity (PI) Measured by VAS Among Participants|The differences in PI were obtained by subtracting the PI at each time point from the Baseline PI score.|Pre-additional dose (baseline) and 2 hours post-additional dose|The full analysis set (FAS), Baseline Observation Carried Forward (BOCF).||mm||Standard Deviation|Mean
811257|NCT01062113|Secondary|Pain Intensity Measured by Visual Analog Scale (VAS)|The Pain intensity was recorded on the 100 mm VAS in the patient diary, where 0 mm=no pain, 100 mm=unbearable maximal pain.|2 hours post-additional dose|The full analysis set (FAS), Baseline Observation Carried Forward (BOCF).||mm||Standard Deviation|Mean
811258|NCT01062113|Secondary|Number of Participants in Each Pain Intensity (PI) With 4 Categories|"Pain intensity was entered in the patient diary on the following categories: No pain, Mild pain, Moderate pain and Severe pain."|2 hours after additional dose|The full analysis set (FAS), Baseline Observation Carried Forward (BOCF).||participants|||Number
811259|NCT01062113|Primary|Efficacy Rate (Percentage) of Patient’s Impression|"Patient’s impression was assessed by self-report and was entered in the patient diary, based on the following categories: Excellent,  Good, Fair and Poor.
Efficacy rate was calculated from the following formula, The number of participants assessed as Excellent or Good over total participants multiplied by 100."|2 hours post-additional dose|The full analysis set (FAS). This analysis set consisted of randomized participants who received the additional dose of the study drug and who were assessed for at least one efficacy endpoint after randomization.||percentage of participants|||Number
811260|NCT01062165|Primary|Total Clearance of Caspofungin||0-72 hours (0, 1, 8, 16, 24, 48, and 72 hours)|||L/hr||Standard Deviation|Mean
811261|NCT01062230|Primary|Maximum Percent Change From Baseline in Intact Parathyroid Hormone Levels on Day 1|All patients received 0.7 mg/m2 of bortezomib on days 1, 4, 8 and 11 of a 21 day cycle, for maximum of three cycles for an average of 18 months. Intact Parathyroid hormone was measured in patients with relapsed/refractory myeloma for osteoblast activation. Other bone markers were examined using similar methods.|Baseline and Day 1|||% change|||Number
811262|NCT01062256|Other Pre-specified|Number of Participant With Cough Severity|Participant's self-assessment of cough severity using 4-point categorical scale (0 = none; no cough present, 1 = mild; cough present but with minimal awareness, easily tolerated, 2 = moderate; cough definitely present and bothersome, but tolerable, or 3 = severe; cough was hard to tolerate; may have caused interference with daily activities and sleeping). Participants were eligible for study if severity of cough at baseline was at least moderate.|Baseline|ITT||Participants|||Number
811263|NCT01062256|Secondary|Number of Participants With Global Evaluation of Study Medication|"Participant-rated evaluation of study product; Participants responded to the following question:
How would you rate this product as a cough reliever?” 0=poor, 1=fair, 2=good, 3=very good, and 4=excellent"|4 hours postdose or early termination|ITT||participants|||Number
811264|NCT01062256|Secondary|Change From Baseline in Cough Severity Scale|Participant's self-assessment of cough severity using a 4-point categorical scale (0 = none; no cough present, 1 = mild; cough present but with minimal awareness, easily tolerated, 2 = moderate; cough definitely present and bothersome, but tolerable, or 3 = severe; cough was hard to tolerate; may have caused interference with daily activities and sleeping). Change from baseline derived by subtracting post baseline cough severity from baseline cough severity. Change from baseline values could have ranged from -1.0 to 3.0 with higher values indicative of greater improvement.|1, 2, 3, and 4 hours postdose|ITT||units on a scale||Standard Deviation|Mean
812475|NCT01070810|Other Pre-specified|Number of Participants Dying Before Hospital Discharge in Patients With Baseline Thiamine Deficiency|Baseline thiamine deficiency was defined as a baseline thiamine level of ≤ 7 nmol/L|Hospital stay, average 2 weeks|||Participants|||Count of Participants
811267|NCT01062256|Primary|Number of Cough Bouts Over 4-hour Postdose Period|Cough bouts defined as one or several cough sounds occurring after one inspiration (one explosive bout between inspiration and expiration). Audio recordings made of participants during 4-hour period after dosing. Based on audio recordings, a trained cough counter counted and recorded the number of cough bouts.|0 to 4 hours postdose|Intent-to-Treat (ITT) Population: all randomized participants who provided baseline cough counts and were dosed with study product.||Cough bouts||Standard Deviation|Mean
811268|NCT01062269|Secondary|Weighted vs. Unweighted BASA Scale|The total aggregate scores for the complete BASA scale were calculated for Cholestyramine 4g, Cholestyramine 12g, and Tang. The total best possible score was 20 and the total worst possible score was 4. A weighted aggregate BASA scale score was also calculated for the Cholestyramine 4g, Cholestyramine 12g, and Tang. The best possible weighted score was 60 and the worst possible weighted score was 4.|1 Day|||Units on Scale||Standard Deviation|Median
811269|NCT01062269|Primary|Patient Acceptability of Orange-flavored Generic Questran (Cholestyramine) vs. Tang (a Commercial Powdered Orange Drink) Via 2 Versions of a Bile Acid Sequestrant Acceptability (BASA) Scale.|The Bile Acid Sequestrant Acceptability Scale has 4 scoring categories: taste, texture, appearance and mixability. Participants rank each category separately. The best possible score for each category is 5 and the worst possible score is 1.|1 Day|Only 42 total subjects were randomized and analyzed. However, all 42 subjects received all 3 treatment arms, just in varying order of administration.||Units on Scale||Standard Deviation|Mean
811270|NCT01062308|Secondary|Passive Range of Motion (ROM)|Passive range of motion (ROM) of shoulder was measured with full circle goniometer. The normal range of movement of flexion and abduction is 180 degree.|14 days and 30 days|On the basis of follow up completion||degree||95% Confidence Interval|Mean
811271|NCT01062308|Primary|Pain: Visual Analog Scale|Visual analog scale (VAS) is an 11-point scale displayed on a 100 mm horizontal line, ranging from 0 (“No Pain”) to 100 (“Worst Pain Imaginable”) Shoulder pain and disability index (SPADI) is a 13-item questionnaire that consists of 2 subscales for pain (5 items) and disability (8 items), which is scored by taking an average of the 2 subscales. Scores range from 0 to 100, with higher scores indicating greater pain and disability|14 days and 30 days|On the basis of complete follow up||mm||95% Confidence Interval|Mean
811276|NCT01054976|Secondary|Change From Baseline in Seoul-Instrumental Activities of Daily Livings (S-IADL)|The Seoul-Instrumental Activities of Daily Living (S-IADL) assesses patients' abilities to perform instrumental and social activities of daily living. These include the ability to prepare a balanced meal, remember appointments, keep financial records, remember to take medication, and so on. It is composed of 15 items, with scores ranging from 0 to 45. Lower scores indicate better functioning.|Baseline, Week 12|Intention-to-Treat analysis set.||scores on a scale||Standard Deviation|Mean
811277|NCT01054976|Secondary|Change From Baseline in Korean Version of Disability Assessment for Demential Scale (DAD-K)|"DAD-K is the Korean version of the Assessment for Dementia Scale, a tool developed to evaluate the Alzheimer patients' function including both basic and instrumental Activities of Daily Livings (ADL). It evaluates one function from various perspectives including behavior initiation, plan and preparation, and valid performance. It consists of 10 questions, each can score either 0 (no) or 1 (yes), if not applicable, patient will check on not applicable (x) which will not count in the calculation. Scores range from 0 to 100. Higher score represents better function"|Baseline, Week 12|Intention-to-Treat analysis set.||scores on a scale||Standard Deviation|Mean
811278|NCT01054976|Secondary|Change From Baseline in Alzheimer’s Disease Assessment Scale – Cognitive Subscale (ADAS-Cog)|The Alzheimer's disease Assessment Scale-Cognitive subscale (ADAS-Cog) is an instrument used to assess cognitive dysfunction in individuals with Alzheimer disease and other dementias. It consists of 11 items, with scores ranging from 1 to 70. Maximum score is 70. Higher scores indicate worsening.|Baseline, Week 12|Intention-to-Treat analysis set.||scores on a scale||Standard Deviation|Mean
811279|NCT01054976|Primary|Change From Baseline in Choice Reaction Time|The Choice Reaction Time is a computerized attention test that evaluates the reaction time and the number of errors by showing patients one card on the computer screen and making them find the same one among similar four cards. The test is performed a total of 12 times.|Baseline, Week 12|Per-protocol (PP) analysis set.||seconds||Standard Deviation|Mean
811281|NCT01055132|Primary|Subject Reported Overall Quality of Vision Using the Contact Lens User Evaluation(CLUE)TM Questionnaire.|The Contact Lens User Evaluation(CLUE)TM questionnaire is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3*SD).|After 5 to 9 days of lens wear|Analysis was conducted on subjects who successfully complete the study.||units on a scale||Standard Deviation|Mean
811282|NCT01055132|Primary|Subject Reported Overall Lens Comfort Using the Contact Lens User Evaluation (CLUE)TM Questionnaire|The Contact Lens User Evaluation(CLUE)TM questionnaire is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3*SD).|After 5 to 9 days of lens wear|Analysis was conducted on subjects who successfully complete the study.||units on a scale||Standard Deviation|Mean
811283|NCT01055132|Primary|Binocular Visual Acuity on LogMAR Scale|Distance (4 meter) high contrast standard resolution (ETDRS) acuity was measured twice binocularly. Distance (4 meter) high contrast standard resolution (ETDRS) acuity was measured twice for each eye. Visual acuity describes the acuteness or sharpness of vision; the ability to perceive small details. Visual acuity is a measure of spacial resolution of the visual processing system; it's tested by requiring the person being tested to identify characters (like letters and numbers)on a chart from a set distance. LogMAR charts are used to assess visual acuity for research studies. LogMAR means Minimum Angle of Resolution. This has lead to the assertion that research is done using a logarithmic progression in size of letters on a test chart gives the most accurate visual acuity measurement. The reason for this is, unlike other charts, LogMAR chart has equal gradation between the letters on the line and the space between the lines. And, there is a fixed number of letters per line.|After 5 to 9 days of lens wear|Analysis was conducted on subjects who successfully complete the study.||LogMAR||Standard Deviation|Mean
811284|NCT01055132|Primary|Monocular Visual Acuity on LogMAR Scale|Distance (4 meter) high contrast standard resolution (ETDRS) acuity was measured twice for each eye. Visual acuity describes the acuteness or sharpness of vision; the ability to perceive small details. Visual acuity is a measure of spacial resolution of the visual processing system; it's tested by requiring the person being tested to identify characters (like letters and numbers)on a chart from a set distance. LogMAR charts are used to assess visual acuity for research studies. LogMAR means Minimum Angle of Resolution. This has lead to the assertion that research is done using a logarithmic progression in size of letters on a test chart gives the most accurate visual acuity measurement. The reason for this is, unlike other charts, LogMAR chart has equal gradation between the letters on the line and the space between the lines. And, there is a fixed number of letters per line.|After 5 to 9 days of lens wear|Analysis was conducted on subjects who successfully complete the study.||logMAR||Standard Deviation|Mean
811285|NCT01055171|Secondary|Proportion of Drinking Days|Proportion of drinking days from 90 days prior to the screening to the follow-up period.|90 days prior to participation in study up to 2-week follow up session (Session 3)|||Drinking days||Standard Error|Mean
811286|NCT01055171|Primary|Test Session Craving Scores (Session 2)|Found by using our Single Item Craving (SIC) scale. A study team member asks the participant to verbally report the level of craving they were experiencing using values between 0 and 100, with 0 representing no craving and 100 extreme craving for alcohol.|Multiple times throughout cue exposure during test session (Session 2)|||units on a scale||Standard Error|Mean
811287|NCT01055171|Primary|Test Session Distress Scores (Session 2)|Found by using our Single Item Distress (SID) scale. A study team member asks the participant to verbally report the level of distress they were experiencing using values between 0 and 100, with 0 representing no distress and 100 extreme distress.|Multiple times throughout cue exposure during test session (Session 2)|||units on a scale||Standard Error|Mean
811288|NCT01055171|Primary|Retrieval Session Craving Scores (Session 1)|Found by using our Single Item Craving (SIC) scale. A study team member asks the participant to verbally report the level of craving they were experiencing using values between 0 and 100, with 0 representing no craving and 100 extreme craving for alcohol.|Multiple times throughout cue exposure during retrieval session (Session 1)|||units on a scale||Standard Error|Mean
811289|NCT01055171|Primary|Retrieval Session Distress Scores (Session 1)|Found by using our Single Item Distress (SID) scale. A study team member asks the participant to verbally report the level of distress they were experiencing using values between 0 and 100, with 0 representing no distress and 100 extreme distress.|Multiple times throughout cue exposure during retrieval session (Session 1)|||units on a scale||Standard Error|Mean
811290|NCT01055184|Primary|Number of Participants Who Shed Virus|number of participants who shed virus above the limit of detection at any timepoint after vaccine. The limit of detection is 0.5 tissue culture infectious doses per mL of nasal wash.|day 0 to day 7 post vaccination|||participants|||Number
811291|NCT01055197|Secondary|Evaluation of the Percentage of the Planned Radiotherapy Dose to Each Site||From start to end of radiation therapy.||||||
811292|NCT01055197|Secondary|Comparison of Time to First Failure||From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 12 months.||||||
811293|NCT01055197|Secondary|Patterns of Failure||From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 12 months.||||||
811294|NCT01055197|Secondary|Comparison of Treatment-related Adverse Events||From start of treatment to end of follow-up.||||||
811295|NCT01055197|Primary|Overall Survival|Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. This analysis was planned to occur when all patients had been potentially followed for at least 12 months.|From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 12 months.|All eligible patients who started study treatment||percentage of participants||95% Confidence Interval|Number
826175|NCT01196104|Secondary|Number of Subjects Reporting Intermittent Coughing Episodes|Number of subjects reporting Intermittent Coughing Episodes|Baseline to Week 16|Safety Population||Number of participants|||Number
811296|NCT01055223|Secondary|Number of Hip Fractures Combined in Males and Females After 12 Months of Exposure to TZD|ICD-9 codes (820.0x, 820.2x, 820.8x) were captured from UB-92 records and HCFA 1500 records. Case is defined as incident cases of fracture with an ICD-9 diagnostic code for hip fracture after the study period begin date (earliest date of the first TZD prescription). For each case, up to four controls were randomly selected from patients with type 2 diabetes exposed to TZD without a fracture diagnosis during follow-up and matched on age (+ 5 yrs), gender, and year of fracture diagnosis.|From the earliest date of first TZD prescription to the fracture diagnosis date (Cases) or the end of follow-up in the database (Controls) between January 1, 1997 to December 31, 2008|The study population consisted of type 2 diabetes patients aged 18 -65 years old exposed to TZD. To be eligible for the study, a subject must have had at least one ICD-9 code for type 2 diabetes and have at least 12 months of exposure to TZD (RSG, PIO or troglitazone) during their follow-up time available in the database.||fractures|||Number
811297|NCT01055223|Secondary|Number of Hip Fractures Combined in Males and Females After 6 Months of Exposure to TZD|ICD-9 codes (820.0x, 820.2x, 820.8x) were captured from UB-92 records and HCFA 1500 records. Case is defined as incident cases of fracture with an ICD-9 diagnostic code for hip fracture after the study period begin date (earliest date of the first TZD prescription). For each case, up to four controls were randomly selected from patients with type 2 diabetes exposed to TZD without a fracture diagnosis during follow-up and matched on age (+ 5 yrs), gender, and year of fracture diagnosis.|From the earliest date of first TZD prescription to the fracture diagnosis date (Cases) or the end of follow-up in the database (Controls) between January 1, 1997 to December 31, 2008|The study population consisted of type 2 diabetes patients aged 18 -65 years old exposed to TZD. To be eligible for the study, a subject must have had at least one ICD-9 code for type 2 diabetes and have at least 6 months of exposure to TZD (RSG, PIO or troglitazone) during their follow-up time available in the database.||fractures|||Number
811298|NCT01055223|Secondary|Number of Fractures of the Hand, Foot, Upper Arm, and Wrist in Males and Females After 12 Months of Exposure to TZD|ICD-9 codes (815.0x, 816.0x, 817.0x, 825.0x, 825.2x, 826.0x, 812.0x, 812.2x, 812.4x, 814.0x) were captured from UB-92 records and HCFA 1500 records. Case is defined as incident cases of fracture with an ICD-9 diagnostic code for hand, foot, upper arm, and wrist fracture after the study period begin date (earliest date of the first TZD prescription). For each case, up to four controls were randomly selected from patients with type 2 diabetes exposed to TZD without a fracture diagnosis during follow-up and matched on age (+ 5 yrs), gender, and year of fracture diagnosis.|From the earliest date of first TZD prescription to the fracture diagnosis date (Cases) or the end of follow-up in the database (Controls) between January 1, 1997 to December 31, 2008|The study population consisted of type 2 diabetes patients aged 18 -65 years old exposed to TZD. To be eligible for the study, a subject must have had at least one ICD-9 code for type 2 diabetes and have at least 12 months of exposure to TZD (RSG, PIO or troglitazone) during their follow-up time available in the database.||fractures|||Number
811299|NCT01055223|Secondary|Number of Fractures of the Hand, Foot, Upper Arm, and Wrist in Males and Females After 6 Months of Exposure to TZD|ICD-9 codes (815.0x, 816.0x, 817.0x, 825.0x, 825.2x, 826.0x, 812.0x, 812.2x, 812.4x, 814.0x) were captured from UB-92 records and HCFA 1500 records. Case is defined as incident cases of fracture with an ICD-9 diagnostic code for hand, foot, upper arm, and wrist fracture after the study period begin date (earliest date of the first TZD prescription). For each case, up to four controls were randomly selected from patients with type 2 diabetes exposed to TZD without a fracture diagnosis during follow-up and matched on age (+ 5 yrs), gender, and year of fracture diagnosis.|From the earliest date of first TZD prescription to the fracture diagnosis date (Cases) or the end of follow-up in the database (Controls) between January 1, 1997 to December 31, 2008|The study population consisted of type 2 diabetes patients aged 18 -65 years old exposed to TZD. To be eligible for the study, a subject must have had at least one ICD-9 code for type 2 diabetes and have at least 6 months of exposure to TZD (RSG, PIO or troglitazone) during their follow-up time available in the database.||fractures|||Number
811300|NCT01055223|Primary|Number of Low Impact Fractures in Males and Females After 12 Months of Exposure to TZD|ICD-9 codes (805-807.4x, 808-810.xx, 812-829.xx) were captured from Uniform Billing-92 records and Health Care Finance Administration records. Case is defined as incident cases of fracture with an ICD-9 diagnostic code for any low impact fracture occurring after the study period begin date (earliest date of the first TZD prescription). For each subject defined as case, up to four controls were randomly selected from patients with type 2 diabetes exposed to TZD without a fracture diagnosis during follow-up and matched to cases on age (+ 5 years), gender, and year of fracture diagnosis.|From the earliest date of first TZD prescription to the fracture diagnosis date (Cases) or the end of follow-up in the database (Controls) between January 1, 1997 to December 31, 2008|The study population consisted of type 2 diabetes patients aged 18 -65 years old exposed to TZD. To be eligible for the study, a subject must have had at least one ICD-9 code for type 2 diabetes and have at least 12 months of exposure to TZD (RSG, PIO or troglitazone) during their follow-up time available in the database.||fractures|||Number
811301|NCT01055223|Primary|Number of Low Impact Fractures in Males and Females After 6 Months of Exposure to TZD|ICD-9 codes (805-807.4x, 808-810.xx, 812-829.xx) were captured from Uniform Billing-92 records and Health Care Finance Administration records. Case is defined as incident cases of fracture with an ICD-9 diagnostic code for any low impact fracture occurring after the study period begin date (earliest date of the first TZD prescription). For each subject defined as case, up to four controls were randomly selected from patients with type 2 diabetes exposed to TZD without a fracture diagnosis during follow-up and matched to cases on age (+ 5 years), gender, and year of fracture diagnosis.|From the earliest date of first TZD prescription to the fracture diagnosis date (Cases) or the end of follow-up in the database (Controls) between January 1, 1997 and December 31, 2008|Type 2 diabetes patients 18-65 years old exposed to TZD. To be eligible for the study, a subject must have had at least one ICD-9 code for type 2 diabetes and have at least 6 months of exposure to TZD (RSG, PIO, or troglitazone) during their follow-up time available in the database.||fractures|||Number
811314|NCT01055314|Primary|Feasibility of the Addition of Cixutumumab to Chemotherapy Determined by Patient Enrollment|Proportion of no Grade 3+ cardiac toxicity.|From start to week 26 of therapy|18 participants were excluded because of ineligibility or insufficient information to assess feasibility.||Proportion of Participants||95% Confidence Interval|Number
812476|NCT01070810|Other Pre-specified|Lactate Level at 24 Hours in Patients With Baseline Thiamine Deficiency|Baseline thiamine deficiency was defined as a baseline thiamine level of ≤ 7 nmol/L|24 hours|||nmol/L||Inter-Quartile Range|Median
811302|NCT01055262|Secondary|Percentage of Participants Discontinued From Wrap Wear by 4 Hours on Any Day|Skin assessments performed after 4 hours of wear, participants discontinued wrap wear for remainder of day (4 hours) if erythema score ≥ 2 with pain upon touch or elevated response. Erythema grading scale: 7 point scale ranging from 0 (no visible erythema) to 3.0 (severe erythema, very intense redness) with 0.5 point increments. Moderate erythema (2.0) was definite redness. Elevated responses included edema, papules, vesicle (≤ 0.5 cm diameter), bullae (> 0.5 cm diameter), miliaria rubra, profunda and follicular response.|Baseline to Day 6|Safety Population||Percentage of participants|||Number
811303|NCT01055262|Secondary|Percentage of Participants Discontinued From Wrap Wear by 8 Hours on Any Day|Skin assessments performed prior to heatwrap application; participant discontinued wrap wear for day (8 hours) if erythema score ≥ 2 with pain upon touch or elevated response. Outcome included those who discontinued wrap wear by 4 hours on same day. Erythema grading scale: 7 point scale that ranged from 0 (no visible erythema) to 3.0 (severe erythema, very intense redness) with 0.5 point increments. Moderate erythema (2.0) was definite redness. Elevated responses included edema, papules, vesicle (≤ 0.5 cm diameter), bullae (> 0.5 cm diameter), miliaria rubra, profunda or follicular response.|Baseline to Day 6|Safety Population||Percentage of participants|||Number
811304|NCT01055262|Secondary|Time to Worsening of Non-zero Erythema Score or Elevated Response Leading to Study Discontinuation|Participants discontinued study due to adverse event (AE) if erythema ≥ 2.0, pain upon touch associated with non-zero erythema score or elevated response on the morning of Day X+1. Erythema grading scale: 0 (no visible erythema) to 3.0 (severe erythema, very intense redness) with 0.5 point increments. Elevated responses included edema, papules, vesicle (≤ 0.5 cm diameter), bullae (> 0.5 cm diameter), miliaria rubra, profunda or follicular response. Pain upon touch: skin grader asked “Does your skin hurt when I touch it?”|Baseline to Day 6|Safety population; N = participants with a non-zero erythema score or elevated response leading to study discontinuation.||Days||Standard Deviation|Mean
811305|NCT01055262|Secondary|Time to First Report of Non-zero Erythema Score or Elevated Response|Erythema grading scale was a 7 point scale that ranged from 0 (no visible erythema) to 3.0 (severe erythema, very intense redness), with 0.5 point increments. Elevated responses included edema, papules, vesicle (≤ 0.5 cm diameter), bullae (> 0.5 cm diameter), miliaria rubra, profunda, or follicular response.|Baseline to Day 6|Safety population; N = participants with any application site finding||Days||Standard Deviation|Mean
811306|NCT01055262|Secondary|Percentage of Participants With Any Non-zero Erythema Score or Elevated Response (Days 1 Through 5 Cumulative)|Events associated with Day X wear (eg, Day 5) assessed on the morning of Day X+1 (eg, Day 6). Erythema grading scale was a 7 point scale that ranged from 0 (no visible erythema) to 3.0 (severe erythema, very intense redness), with 0.5 point increments. Elevated responses included edema, papules, vesicle (≤ 0.5 cm diameter), bullae (> 0.5 cm diameter), miliaria rubra, profunda, or follicular response.|Day 2 to Day 6|Safety Population||Percentage of participants||95% Confidence Interval|Number
811307|NCT01055262|Secondary|Time to First Significant Skin Event|Significant skin event: at least moderate erythema, elevated response or pain upon touch (associated with non-zero erythema). Erythema grading scale: 0 (no visible erythema) to 3.0 (severe erythema, very intense redness) with 0.5 point increments. Moderate erythema (2.0): definite redness. Elevated responses: edema, papules, vesicle (≤ 0.5 cm diameter), bullae (> 0.5 cm diameter), miliaria rubra, profunda or follicular response. Pain upon touch: skin grader asked “Does your skin hurt when I touch it?”|Baseline to Day 6|Safety population; Number of participants analyzed (N) = number of participants with significant skin event.||Days||Standard Deviation|Mean
811308|NCT01055262|Secondary|Percentage of Participants With Significant Skin Event (Days 1 Through 4 Cumulative)|Events associated with Day X wear (eg, Day 4) assessed on the morning of Day X+1 (eg, Day 5). Significant skin event: at least moderate erythema, elevated response or pain upon touch (associated with non-zero erythema). Erythema grading scale: 0 (no visible erythema) to 3.0 (severe erythema, very intense redness) with 0.5 point increments. Moderate erythema (2.0): definite redness. Elevated responses: edema, papules, vesicle (≤ 0.5 cm diameter), bullae (> 0.5 cm diameter), miliaria rubra, profunda or follicular response. Pain upon touch: skin grader asked “Does your skin hurt when I touch it?”|Day 2 to Day 5|Safety population||Percentage of participants||95% Confidence Interval|Number
811309|NCT01055262|Primary|Percentage of Participants With a Significant Skin Event (Day 5 Cumulative)|Events associated with Day X wear (eg, Day 5) assessed morning of Day X+1 (eg, Day 6). Significant skin event: at least moderate erythema, elevated response or pain upon touch (associated with non-zero erythema). Erythema grading scale: 0 (no visible erythema) to 3.0 (severe erythema, very intense redness) with 0.5 increments. Moderate erythema (2.0): definite redness. Elevated response: edema, papules, vesicle (≤ 0.5 centimeter [cm] diameter), bullae (> 0.5 cm diameter), miliaria rubra, profunda or follicular response. Pain upon touch: skin grader asked “Does your skin hurt when I touch it?”|Day 2 to Day 6|Safety population: participants who wore the product at least once during the study||Percentage of participants||95% Confidence Interval|Number
811310|NCT01055314|Secondary|Response Rate (CR + PR)|Proportion of patients with complete or partial response. Complete Response (CR): Complete disappearance of the tumor confirmed at > 4 weeks. Partial Response (PR): At least 64% decrease in volume compared to the measurement obtained at study enrollment; Overall Response (OR) = CR + PR.|From the start of treatment until a maximum of 2 cycles (21 days per cycle) of treatment in the absence of disease progression or unacceptable toxicities|20 participants were excluded because of ineligibility or absence in overall response evaluation.||Proportion of Participants||95% Confidence Interval|Number
811311|NCT01055314|Primary|Event-Free Survival|Probability of no relapse, secondary malignancy, or death after 3 years in the study.|3 years|9 participants who were ineligible or did not receive treatment were excluded.||Probability||95% Confidence Interval|Number
811312|NCT01055314|Primary|Incidence of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 4.0|Number of patients with grade 3+ adverse events (AE) during therapy. (Grade 3+) = (Grade 3 + Grade 4 + Grade 5) . Grade 3: Severe and undesirable AE; Grade 4: Life threatening or disabling AE; Grade 5: Death related to AE.|Up to 54 weeks|9 participants who were ineligible or did not receive treatment were excluded.||Participants|||Number
811313|NCT01055314|Primary|Feasibility of the Addition of Temozolomide to Chemotherapy Determined by Patient Enrollment|Proportion of no Grade 4+ non-hematologic toxicity.|From start to week 26 of therapy|13 participants were excluded because of ineligibility or insufficient information to assess feasibility.||Proportion of Participants||95% Confidence Interval|Number
811315|NCT01055457|Primary|Distance Visual Acuity (LogMAR)|Distance Visual Acuity (LogMAR) was assessed for each subject eye at 1-week, 2-week, 1-month and 3-month follow-up evaluations. The average Visual Acuity (LogMAR) for each time point and lens was reported.|Up to 3 Months Post Lens Wear|All subjects that completed the study.||LogMAR|Subjects Eyes|Standard Deviation|Mean
811316|NCT01055457|Primary|Slit Lamp Findings (SLF)|Slit Lamp Findings were assessed for each subject eye at baseline, 1-day, 1-week, 2-week, 1-month and 3-month follow-up evaluations. SLF consisted of Edema, Corneal Neovascularization, Cornela Staining, Injection, Tarsal Abnormalities and Other findings; each was graded on a 5-likert Scale (Grade: None, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate and Grade 4: Severe). The number of eyes with Grade 2 or higher across all time points for each SLF variable was reported.|Up to 3 months Post Lens Wear|All subjects that completed the study.||eyes (2 per subject)|Subject eyes||Number
811317|NCT01055613|Primary|Distance Visual Acuity (LogMAR)|Distance visual acuity was collected at the 1-, 2-, 3-week and 1- and 3- month follow-up evaluations. The average LogMAR across all visits for each lens type was reported.|Up to 3 Months|The analysis population consists of subjects that completed all study visits without a major protocol deviation.||LogMAR|Participants|Standard Deviation|Mean
811318|NCT01055613|Primary|Slit Lamp Findings|Each subjects' eye was examined using a bio-microscope. Slit lamp findings were graded with a 5-point scale (i.e. Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). The number of eyes with Grade 3 or higher for each lens was reported for each assessment.|3 months|The analysis population consists of all subjects that were dispensed a solution during the course of the study.||Subjects Eyes|Participants||Number
811319|NCT01055639|Secondary|Pittsburgh Sleep Quality Index|The 19-item Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 1989) is the most commonly used measure of self-rated sleep quality, with good reliability (alpha = .83, test-retest = .85) and validity (kappa = 0.75) for distinguishing good and poor sleepers. A survey recently conducted by the IMMPACT group indicated that sleep is one of the domains most important to patients with chronic pain (Turk et al., 2008), and the PSQI is the scale most frequently used to evaluate sleep quality in studies of chronic pain patients (Cole et al., 2007). Scores range from 0 (good sleep) to 42 (poor sleep).|8 weeks|||units on a scale||Standard Deviation|Mean
811320|NCT01055639|Secondary|PTSD Checklist|The 17-item PTSD Checklist (Weathers et al., 1994) will be used to assess PTSD symptoms. In combat veterans, this questionnaire has high test-retest reliability (0.96) and validity as indicated by a kappa of 0.64 for diagnosis of PTSD using the SCID (Weathers et al., 1993). Scores range from 17 (low PTSD) to 85 (high PTSD).|8 weeks|||units on a scale||Standard Deviation|Mean
811321|NCT01055639|Secondary|Pain Anxiety Symptom Scale - 20|Anxiety will be assessed with the 20-item Pain Anxiety Symptoms Scale-Short Form (PASS-20; McCracken & Dhingra, 2002). Pain anxiety captures fears patients associate with their symptoms, which are typically associated with the belief that their pain signals harm. High levels of pain anxiety compromise patient’s activity levels, participation in rehabilitation, and performance on functional tests. The instrument is a valid and reliable measure of anxiety symptoms in pain populations (McCracken et al., 1996; Roelofs et al., 2004). The PASS-20 items are scored on a 6-point Likert scale and assess cognitive, escape/avoidance, fear, and physiological anxiety dimensions. Internal consistency is high and correlation between the short and long form is excellent (alpha=.81; r=.97). This measure has been recommended by the VA and demonstrated sensitivity to treatment in the pilot sample (National VA Pain Outcomes Working Group, 2003). Scores range from 0 (least anxiety) to 100 (most anxiety).|8 weeks|||units on a scale||Standard Deviation|Mean
811322|NCT01055639|Secondary|Patient Health Questionnaire-9|The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. The PHQ-9 incorporates DSM-IV depression diagnostic criteria with other leading major depressive symptoms into a brief self-report tool. The tool rates the frequency of the symptoms which factors into the scoring severity index. Scores range from 0 (lowest level of depressive symptoms) to 27 (highest level of depressive symptoms).|8 weeks|||units on a scale||Standard Deviation|Mean
811323|NCT01055639|Secondary|SF-12 PCS|Physical health-related quality of life will be measured using the Physical Component Summary score of the Medical Outcomes Study 12-Item Short Form Health Survey (SF-12; Ware et al., 1994). This measure is widely used with populations with chronic disease. The Physical and Mental Component Summary scores correlate .91 and .92 with the corresponding scores derived from the SF-36, and 2-week test-retest reliability correlations were .89 and .76 (Ware et al., 1994). The Short Form Health Survey is recommended by the IMMPACT group (Dworkin et al., 2005). Scores range from 0 (lowest functioning) to 100 (highest functioning).|8 weeks|||units on a scale||Standard Deviation|Mean
811324|NCT01055639|Secondary|SF-12 MCS|6-item self-report measure of mental health-related quality of life. Subscale of the Medical Outcomes Study 12-Item Short Form Health Survey (SF-12; Ware et al., 1994). This measure is widely used with populations with chronic disease. The Physical and Mental Component Summary scores correlate .91 and .92 with the corresponding scores derived from the SF-36, and 2-week test-retest reliability correlations were .89 and .76 (Ware et al., 1994). The Short Form Health Survey is recommended by the IMMPACT group (Dworkin et al., 2005). Scores range from 0 (lowest functioning) to 100 (highest functioning).|8 weeks|||units on a scale||Standard Deviation|Mean
811325|NCT01055639|Secondary|West Haven-Yale Multidimensional Pain Inventory - Activity Subscales|The West Haven-Yale Multidimensional Pain Inventory (MPI; Kerns et al., 1985) contains 52 items forming 12 subscales. For this study, we used four subscales assessing various types of activities. Household Chores (5 items); Outdoor Work (5 items); Activities Away From Home (4 items); and Social Activities (4 items). The MPI has been used extensively in outcome research with heterogeneous samples of chronic pain patients, including veterans, and has demonstrated sensitivity to treatment change (Altmaier et al., 1992; Mikail et al., 1993). Individual items are rated on a 7-point Likert scale from 0-6, and subscales are scored by averaging items together. Therefore, the score for Part III, General Activity, is composed of an average of the 18 items in the Household Chores (5 items); Outdoor Work (5 items); Activities Away From Home (4 items); and Social Activities (4 items) subscales. The final score ranges from 0 (lowest level of activity) to 6 (highest level of activity).|8 weeks|||units on a scale||Standard Deviation|Mean
811346|NCT01062841|Primary|Total Number of Ceftazidime-resistant GNB (Gram-negative Bacilli) Isolated||From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study|Participants with >1 follow-up visit||Total Number of Ceftazidime-RGNB isolate|||Number
811326|NCT01055639|Secondary|Brief Pain Inventory-severity Subscale|The Brief Pain Inventory Short Form (BPI; Cleeland & Ryan, 1994) includes a 4-item pain severity subscale measuring the level of pain over the past week on average, at its worst, at its least, and currently. This measure is recommended by the IMMPACT group as a pain assessment tool (Dworkin et al., 2005). Scores range from 0 (least pain severity) to 10 (most pain severity).|8 weeks|||units on a scale||Standard Deviation|Mean
811327|NCT01055639|Primary|Brief Pain Inventory-interference Subscale|The primary outcome measure for the proposed study is the Brief Pain Inventory Short Form Interference subscale (BPI; Cleeland & Ryan, 1994). This 7-item scale, recommended by the IMMPACT group as a measure of functioning (Dworkin et al., 2005), measures the degree to which pain interferes with various aspects of life, including mobility, social activities, and mood. Scores range from 0 (least interference due to pain) to 10 (most interference due to pain).|8 weeks|||units on a scale||Standard Deviation|Mean
811328|NCT01055704|Secondary|Stool Consistency as Reported From the Bristol Stool Scale|"Bristol Stool Scale a medical aid designed to classify the form of human feces into seven categories or types. Types 1 and 2 indicate constipation, with 3 and 4 being the ideal stools especially the latter, as they are the easiest to defecate, and 5–7 tending towards diarrhea."|Daily|||Units on a scale||Standard Error|Mean
811329|NCT01055704|Secondary|Stool Frequency|Stool frequency was self reported in a daily bowel pattern diary for 13 days.|daily|||Stools||Standard Error|Mean
811330|NCT01055704|Secondary|Colonic Filling at 6 Hours|Percent of solids reaching the colon at 6 hours|6 hours|||Percentage||Standard Error|Mean
811331|NCT01055704|Secondary|Colonic Geometric Center at 48 Hours|The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit. A GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.|48 hours|||Units on a scale||Standard Error|Mean
811332|NCT01055704|Secondary|Colonic Geometric Center at 4 Hours|The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit. A GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.|4 hours|||Units on a scale||Standard Error|Mean
811333|NCT01055704|Secondary|T1/2 of Gastric Emptying of Solid||4 hours|||Minutes||Standard Error|Mean
811334|NCT01055704|Secondary|T1/2 of Ascending Colon Emptying||24 hours|||hours||Standard Error|Mean
811335|NCT01055704|Primary|Colonic Geometric Center at 24 Hours|The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit. A GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.|24 hours|||Units on a scale||Standard Error|Mean
811336|NCT01062763|Primary|Change of Diastolic Blood Pressure|Change of diastolic blood pressure from baseline to study end at four months.|4 months|Analyzed by intention to treat and last observation carried forward||mm Hg||95% Confidence Interval|Mean
811337|NCT01062763|Secondary|Adverse Effects||4 months|Intention to treat||participants|||Number
811338|NCT01062763|Primary|Change of of Systolic Blood Pressure|Change of systolic blood pressure from baseline to study end at four months.|4 months|Analysis by intention to treat using LOCF||mm Hg||95% Confidence Interval|Mean
811339|NCT01062841|Secondary|Total Number of Residents With New Resistant GNB (Ceftazidime or Ciprofloxacin Gram-negative Bacilli) Acquisition||From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study|Participants with >1 follow-up visit, and who were at-risk to acquire a new R-GNB colonization (not colonized at baseline)||Number of Residents with New R-GNB|Participants||Number
811340|NCT01062841|Secondary|Total Number of Residents With New VRE (Vancomycin Resistant Enterococci) Acquisition||From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study|Participants with > 1 follow-up visit, and who were at-risk to acquire a new VRE colonization (not colonized at baseline)||Number of Residents with New VRE|Participants||Number
811341|NCT01062841|Secondary|Total Number of Residents With New MRSA (Methicillin Resistant Staphylococcus Aureus) Acquisition||From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study|Participants with >1 follow-up visit, and were at-risk to acquire new MRSA colonization (not colonized at baseline)||Number of Residents with New MRSA|Participants||Number
811342|NCT01062841|Secondary|Number of Incident Feeding-tube Associated Pneumonias||From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study|Participants with indwelling feeding tube present (PEG tube), and had >1 follow-up visit||Number of feeding-tube associated pneu|Participants||Number
811343|NCT01062841|Secondary|Number of Incident Feeding Tube-associated Skin and Soft Tissue Infections||From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study|Participants with an indwelling feeding tube present (PEG tube), and had >1 follow-up visit||Numer of feeding-tube SSTIs|Participants||Number
811344|NCT01062841|Secondary|Number of All (First and Recurrent) Incident Urinary Catheter-associated Urinary Tract Infections||From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study|Participants with only an indwelling urinary catheter present and >1 follow-up visit||Number of CAUTI|Participants||Number
811345|NCT01062841|Primary|Total Number of Ciprofloxacin-resistant GNB (Gram-negative Bacilli) Isolated||From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study|Participants with >1 follow-up visit||Total Number of Ciprofloxacin-RGNB|||Number
811347|NCT01062841|Primary|Total Number of VRE (Vancomycin Resistant Enterococci) Isolated||From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study|Participants with >1 follow-up visit||Total Number of VRE isolates|||Number
811348|NCT01062841|Primary|Total Number of MRSA (Methicillin Resistant Staphylococcus Aureus) Isolated||From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study|Participants with >1 follow-up visit||Total Number of MRSA isolates|||Number
811349|NCT01062841|Secondary|Number of First Incident Urinary Catheter-associated Urinary Tract Infections||From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study|Participants with only a urinary catheter present and >1 follow-up visit||Number of First CAUTI|Participants||Number
811350|NCT01062841|Primary|Total Number of MDRO (Multidrug Resistant Organisms) Isolated|Total Number of MDROs isolated across all MDROs and all anatomic sites for all enrolled residents with indwelling devices over the duration of the study period|From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study|Residents enrolled with >1 follow-up visit||Total Number of MDRO isolates|||Number
811351|NCT01065350|Secondary|Average Change in Stroke Volume Variation (SVV)|SVV was recorded every minute for a total of 30 minutes after anesthesia was induced and results were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. SVV is a dynamic flow-based parameter and together with cardiac output provides an indication of fluid responsiveness. The average change in SVV (as compared to baseline SVV) during the specified time intervals is reported. SVV is calculated by taking the SVmax – SVmin /*100/ SV mean.|Baseline, 5 minutes, 10 minutes post induction|The analysis population of 38/35 (vs. 43/41 at baseline) is due to the NICOM not functioning properly during certain aspects of the procedure and therefore, did not provide a number.||Percentage of mean stroke volume||Standard Deviation|Mean
811352|NCT01065350|Secondary|Average Change in Stroke Volume Index (SVI)|SVI was recorded every minute for a total of 30 minutes after anesthesia was induced and results were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The average change in SVI (as compared to baseline SVI) during the specified time intervals is reported. To determine SVI, stroke volume is divided by the body surface area in order to account for body size.|Baseline, 5 minutes, 10 minutes post induction|The analysis population of 41/40 (vs. 43/41 at baseline) is due to the NICOM not functioning properly during certain aspects of the procedure and therefore, did not provide a number.||Milliters per beat per m^2 of body area||Standard Deviation|Mean
811353|NCT01065350|Secondary|Average Change in Stroke Volume (SV)|SV was recorded every minute for a total of 30 minutes after anesthesia was induced and results were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The average change in SV from baseline during the specified time intervals is reported. SV is the milliliters of blood ejected during each contraction of the heart.|Baseline, 5 minutes, 10 minutes post induction|The analysis population of 41/40 (vs. 43/41 at baseline) is due to the NICOM not functioning properly during certain aspects of the procedure and therefore, did not provide a number.||Milliliters of blood per beat||Standard Deviation|Mean
811354|NCT01065350|Secondary|Average Change in Total Peripheral Resistance Index (TPRI)|TPRI was recorded every minute for a total of 30 minutes after anesthesia was induced and results were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The average change in TPRI from baseline during the specified time intervals is reported.|Baseline, 5 minutes, 10 minutes post induction|The analysis population of 39/39 (vs. 43/41 at baseline) is due to the NICOM not functioning properly during certain aspects of the procedure and therefore, did not provide a number.||dynes * sec/cm^-5/m^2||Standard Deviation|Mean
811355|NCT01065350|Secondary|Average Change in Total Peripheral Resistance (TPR)|TPR was recorded every minute for a total of 30 minutes after anesthesia was induced and readings were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The average change in TPR from baseline during the specified time intervals is reported. TPR is the overall resistance to blood flow through the systemic blood vessels.|Baseline, 5 minutes, 10 minutes post induction|The analysis population of 39/38 (vs. 43/41 at baseline) is due to the NICOM not functioning properly during certain aspects of the procedure and therefore, did not provide a number.||dynes * sec/cm^-5||Standard Deviation|Mean
811356|NCT01065350|Secondary|Average Change in Mean Arterial Pressure (MAP)|"MAP was recorded every minute for a total of 30 minutes after anesthesia was induced and readings were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The average change in MAP from baseline during the specified time intervals is reported.
MAP is a term used in medicine to describe an average blood pressure in an individual. It is defined as the average arterial pressure during a single cardiac cycle."|Baseline, 5 minutes, 10 minutes post induction|The analysis population of 43/40 (vs. 43/41 at baseline) is due to the NICOM not functioning properly during certain aspects of the procedure and therefore, did not provide a number.||Millimeters of mercury (mmHg)||Standard Deviation|Mean
811357|NCT01065350|Secondary|Average Change in Diastolic Blood Pressure (DBP)|Blood pressure was recorded every minute for a total of 30 minutes after anesthesia was induced and readings were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The average change in DBP (as compared to baseline DBP) during the specified time intervals is reported.|Baseline, 5 minutes, 10 minutes post induction|||mmHg||Standard Deviation|Mean
811358|NCT01065350|Secondary|Average Change in Systolic Blood Pressure (SBP)|Blood pressure was recorded every minute for a total of 30 minutes after anesthesia was induced and readings were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The average change in SBP (as compared to baseline SBP) during the specified time intervals is reported.|Baseline, 5 minutes, 10 minutes post induction|||mmHg||Standard Deviation|Mean
811359|NCT01065350|Secondary|Average Change in Heart Rate (HR)|HR was recorded every minute for a total of 30 minutes after anesthesia was induced and readings were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The average change in HR (as compared to baseline HR) during the specified time intervals is reported.|Baseline, 5 minutes, 10 minutes post induction|||Beats per minute||Standard Deviation|Mean
812868|NCT01074463|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Cmax.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
811360|NCT01065350|Secondary|Average Change in Cardiac Index (CI)|"CI was recorded every minute for a total of 30 minutes after anesthesia was induced and readings were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The average change in CI as compared to the baseline CI during the specified time intervals is reported.
To determine CI, cardiac output is divided by the body surface area in order to account for body size."|Baseline, 5 minutes, 10 minutes post induction|The analysis population of 41/40 (vs. 43/41 at baseline) is due to the NICOM not functioning properly during certain aspects of the procedure and therefore, did not provide a number.||Liters per minute per m^2 of body area||Standard Deviation|Mean
811361|NCT01065350|Secondary|Average Change in Cardiac Output (CO)|"CO was recorded every minute for a total of 30 minutes after anesthesia was induced and readings were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The average change in CO as compared to baseline CO during the specified time intervals is reported.
CO is defined as the quantity of blood ejected per minute by the heart into the systemic circulation. It is the product of the heart rate (HR) (beats per minute) times the stroke volume (SV) (milliliters of blood ejected during each contraction)."|Baseline, 5 minutes, 10 minutes post induction|The analysis population of 41/40 (vs. 43/41 at baseline) is due to the NICOM not functioning properly during certain aspects of the procedure and therefore, did not provide a number.||Liters per minute||Standard Deviation|Mean
811362|NCT01065350|Secondary|Percent of Subjects With a Greater Than 20% Decrease in Mean Arterial Pressure (MAP) Following Induction of General Anesthesia|MAP was recorded every minute for a total of 30 minutes after anesthesia was induced and readings were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The percentage of subjects experiencing decreases in MAP of greater than 20% during the specified time intervals is reported, as compared to the baseline MAP reading.|Baseline, 5 minutes, 10 minutes, 30 minutes post induction|85 patients were enrolled (43 Propofol/42 Ketofol). However, one subject randomized to the ketofol group received the wrong study drug and in a larger dose than indicated in protocol. This subject was excluded from the analysis and baseline measures.||Percentage of subjects|||Number
811363|NCT01065350|Secondary|Percent of Subjects With a Greater Than 20% Decrease in Diastolic Blood Pressure (DBP) Following Induction of General Anesthesia|Blood pressure was recorded every minute for a total of 30 minutes after anesthesia was induced and readings were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The percentage of subjects experiencing decreases in DBP of greater than 20% during the specified time intervals is reported, as compared to the baseline DBP reading. The second or lower number of a blood pressure reading is the DBP and is the measure taken when your heart is at rest.|Baseline, 5 minutes, 10 minutes, 30 minutes post induction|85 patients were enrolled (43 Propofol/42 Ketofol). However, one subject randomized to the ketofol group received the wrong study drug and in a larger dose than indicated in protocol. This subject was excluded from the analysis and baseline measures.||Percentage of subjects|||Number
811364|NCT01065350|Primary|Percent of Subjects With a Greater Than 20% Decrease in Systolic Blood Pressure (SBP) Following Induction of General Anesthesia|Blood pressure was recorded every minute for a total of 30 minutes after anesthesia was induced and readings were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The percentage of subjects experiencing decreases in SBP of greater than 20% during the specified time intervals is reported, as compared to the baseline systolic blood pressure reading. There are two numbers in a blood pressure reading, and they are expressed in millimeters of mercury (mm Hg). This tells how high in millimeters the pressure of your blood raises a column of mercury. The numbers usually are expressed in the form of a fraction; an example of a blood pressure reading is 120/80 mm Hg. The first, or top, number (120 in the example) is the systolic pressure. The systolic pressure is the measure of your blood pressure as the heart contracts and pumps blood.|Baseline, 5 minutes, 10 minutes, 30 minutes post induction|85 patients were enrolled (43 Propofol/42 Ketofol). However, one subject randomized to the ketofol group received the wrong study drug and in a larger dose than indicated in protocol. This subject was excluded from the analysis and baseline measures.||Percentage of subjects|||Number
811365|NCT01065428|Secondary|Neuromechanical Efficiency (NME)|NME is the ratio between inspiratory pressure generation and EAdi (Paw/EAdi).|at 30 minutes of the spontaneous breathing trials (SBT)|||cmH2O/uV||Standard Deviation|Mean
811366|NCT01065428|Primary|Neuroventilatory Efficiency (NVE)|NVE is the ratio of tidal volume and diaphragm electrical activity (Vt/EAdi).It is a value describing how effective a patient's breathing is.|at 30 minutes of the spontaneous breathing trials (SBT)|||ml/uV||Standard Deviation|Mean
811367|NCT01065454|Secondary|Osteopontin - Change From Baseline to Week 16|Osteopontin is a cytokine-like pro-fibrotic mediator, which is expressed in cardiovascular tissues. Its expression is induced by increased pressure and volume load in the myocardium, kidney and lung. Therefore, osteopontin may be used as a prognostic marker in patients with cardiovascular diseases.|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.||µg/mL||Standard Deviation|Mean
811368|NCT01065454|Secondary|Asymmetric Dimethylarginine (ADMA) - Change From Baseline to Week 16|Asymmetric dimethylarginine (ADMA) is an endogenous inhibitor of nitric oxides. Recent clinical studies have indicated that ADMA may have diagnostic relevance as a novel cardiovascular risk marker.|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.||µmol/L||Standard Deviation|Mean
811369|NCT01065454|Secondary|Troponin T - Change From Baseline to Week 16|Troponin T is a cardiac-specific protein which is released from damaged or injured heart muscle cells.|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.||µg/L||Standard Deviation|Mean
811406|NCT01065766|Primary|Change From Baseline to Treatment in FPG at Week 24|Blood glucose was measured on a fasting basis (collected after an 8- to 10-hour fast). FPG is expressed as mg/dL. Therefore, this change from baseline reflects the Week 24 FPG minus Week 0 FPG.|Baseline and Week 24|Participants with a pre-treatment and a 24-week post-treatment measurement of FPG.||mg/dL||Standard Deviation|Mean
812869|NCT01074502|Primary|Percentage of Patients Achieving a Clear or Almost Clear PGA at 16 Weeks||Baseline to 16 weeks||||||
811370|NCT01065454|Secondary|N-terminal Pro-brain Natriuretic Peptide (NT-pro BNP) - Change From Baseline to Week 16|N-terminal pro-brain natriuretic peptide (NT-pro BNP) levels in the blood are used for screening, diagnosis of acute congestive heart failure (CHF) and may be useful to establish prognosis in heart failure.|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.||pg/mL||Standard Deviation|Mean
811371|NCT01065454|Secondary|Cystatin C - Change From Baseline to Week 16|Cystatin C is a biomarker for predicting new onset or deteriorating cardiovascular disease.|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.||ng/mL||Standard Deviation|Mean
811372|NCT01065454|Secondary|Minnesota Living With Heart Failure Questionnaire (MLHF) Score - Change From Baseline to Week 16|The self-reported Minnesota Living with Heart Failure questionnaire (MLHF) is designed to measure the effects of PH and PH-specific treatments on an individual’s quality of life. The MLHF total score can range from 0 (best) to 105 (worst).|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.||Scores on a scale||Standard Deviation|Mean
811373|NCT01065454|Secondary|EQ-5D Utility Score - Change From Baseline to Week 16|EQ-5D utility score is a Quality-of-Life patient reported outcome measure. An increase in the utility score represents an improvement in quality of life. The score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.||Scores on a scale||Standard Deviation|Mean
811374|NCT01065454|Secondary|Borg CR 10 Scale - Change From Baseline to Week 16|"The Borg CR10 Scale is a patient reported outcome measure used in clinical diagnosis of e.g. breathlessness and dyspnea. It documents the patient's exertion during a physical test. Low values indicate low levels of exertion, high values indicate more intense exertion reported by the patient. The score ranges from 0 (Nothing at all) to 10 (“Extremely strong – Maximal”)."|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.||Scores on a scale||Standard Deviation|Mean
811375|NCT01065454|Secondary|Percentage of Participants With Clinical Worsening|The combined endpoint “time to clinical worsening”, made up of the following components, defined by the first occurrence: all cause mortality, including cardiovascular mortality; first hospitalization for a cardiovascular event, including heart failure, acute myocardial infarction, stroke or ventricular arrhythmia; upgrade of the HTx (heart transplantation) status to next higher level; need for IV diuretics; persistent worsening of WHO functional class due to deterioration of PH or cardiac function.|At visit 6 (16 weeks)|Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one post-baseline measurement were included in the analysis.||Percentage of participants|||Number
811376|NCT01065454|Secondary|WHO (World Health Organization) Functional Class - Change From Baseline to Week 16|The WHO functional assessment of pulmonary arterial hypertension ranged from functional class I (Patients with PH but without resulting limitation of physical activity) to class IV (Patients with PH with inability to carry out any physical activity without symptoms. These patients manifest signs of right-heart failure.). Changes to a lower WHO functional class resemble improvement, changes to a higher functional class resemble deterioration of PAH.|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.||Percentage of participants|||Number
811377|NCT01065454|Secondary|6-minute Walking Distance (6MWD) - Change From Baseline to Week 16|6-minute walking distance (6MWD) is a measure for the objective evaluation of a patient's functional exercise capacity.|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.||m||Standard Deviation|Mean
811378|NCT01065454|Secondary|Ratio of Mitral Peak Velocity of Early Filling to Mitral Peak Velocity of Late Filling (E/A) - Change From Baseline to Week 16|E/A ratio is a measured echocardiography parameter and describes the ratio of mitral peak velocity of early filling to mitral peak velocity of late filling. It is acquired during a non-invasive echocardiography examination.|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.||E/A ratio||Standard Deviation|Mean
811379|NCT01065454|Secondary|E-wave Deceleration Time - Change From Baseline to Week 16|E-wave deceleration time is a measured echocardiography parameter. It is acquired during a non-invasive echocardiography examination.|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.||msec||Standard Deviation|Mean
811380|NCT01065454|Secondary|Left Ventricular End-diastolic Volume (LVEDV) - Change From Baseline to Week 16|Left ventricular end-diastolic volume (LVEDV) is a measured echocardiography parameter. It is acquired during a non-invasive echocardiography examination.|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.||mL||Standard Deviation|Mean
824693|NCT01184053|Secondary|Progression Free Survival in Patients Treated With Trisenox®|Progression-Free survival is the period from start of treatment until disease progression, death, or date of last contact.|28 days|||Participants|||Count of Participants
811381|NCT01065454|Secondary|Left Ventricular End-systolic Volume (LVESV) - Change From Baseline to Week 16|Left ventricular end-systolic volume (LVESV) is a measured echocardiography parameter. It is acquired during a non-invasive echocardiography examination.|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.||mL||Standard Deviation|Mean
811382|NCT01065454|Secondary|Left Ventricular Ejection Fraction (LVEF) - Change From Baseline to Week 16|The left ventricular ejection fraction work index (LVEF) is a calculated echocardiography parameter. LVEF is derived from the directly measured parameters left ventricular end-diastolic volume (LVEDV) and left ventricular end-systolic volume (LVESV). These 2 parameters are acquired during a non-invasive echocardiography examination. Formula: LEVF = 100*(LVEDV - LVESV)/LVEDV|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.||Percentage||Standard Deviation|Mean
811383|NCT01065454|Secondary|Systolic Pulmonary Arterial Pressure (PAPsyst) - Change From Baseline to Week 16|Systolic pulmonary arterial pressure (PAPsyst) is a directly measured hemodynamic parameter acquired during a right heart catheterization.|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.||mmHg||Standard Deviation|Mean
811384|NCT01065454|Secondary|Tricuspid Annular Plane Systolic Excursion (TAPSE) - Change From Baseline to Week 16|The tricuspid annular plane systolic excursion (TAPSE) is a measured echocardiography parameter. It is acquired during a non-invasive echocardiography examination.|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.||mm||Standard Deviation|Mean
811385|NCT01065454|Secondary|Pulmonary Capillary Wedge Pressure (PCWP) - Change From Baseline to Week 16|Pulmonary capillary wedge pressure (PCWP) is a directly measured hemodynamic parameter acquired during a right heart catheterization.|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.||mmHg||Standard Deviation|Mean
811386|NCT01065454|Secondary|Transpulmonary Pressure Gradient (TPG) - Change From Baseline to Week 16|The transpulmonary pressure gradient (TPG) is a calculated hemodynamic parameter. TPG is calculated from the directly measured parameters mean pulmonary arterial pressure (PAPmean) and pulmonary capillary wedge pressure (PCWP). These 2 parameters are acquired during a right heart catheterization. Formula: TPG = PAPmean - PCWP|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.||mmHg||Standard Deviation|Mean
811387|NCT01065454|Secondary|Systemic Vascular Resistance Index (SVRi) - Change From Baseline to Week 16|The systemic vascular resistance index (SVRi) is a calculated hemodynamic parameter. SVRi is derived from the systemic vascular resistance (SVR) normalized by the body surface area (BSA). Formula: SVRi = 80*(SAPmean - RAPmean)*BSA/CO|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.||dyn*s*cm^-5*m^2||Standard Deviation|Mean
811388|NCT01065454|Secondary|Systemic Vascular Resistance (SVR) - Change From Baseline to Week 16|The systemic vascular resistance (SVR) is a calculated hemodynamic parameter. SVR is derived from the directly measured parameter mean right atrial pressure (RAPmean) and the calculated parameter mean systemic arterial pressure (SAPmean) divided by the cardiac output (CO). RAPmean is acquired during a right heart catheterization. CO is a calculated hemodynamic parameter, too. Formula: SVR = 80*(SAPmean - RAPmean)/CO|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.||dyn*s*cm^-5||Standard Deviation|Mean
811389|NCT01065454|Secondary|Pulmonary Vascular Resistance Index (PVRi) - Change From Baseline to Week 16|The pulmonary vascular resistance index (PVRi) is a calculated hemodynamic parameter. PVRi is derived from the pulmonary vascular resistance (PVR) normalized by the body surface area (BSA). Formula: PVRi = 80*(PAPmean - PCWP)*BSA/CO|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.||dyn*s*cm^-5*m^2||Standard Deviation|Mean
811390|NCT01065454|Secondary|Pulmonary Vascular Resistance (PVR) - Change From Baseline to Week 16|The pulmonary vascular resistance (PVR) is a calculated hemodynamic parameter. PVR is derived from the directly measured parameters mean pulmonary arterial pressure (PAPmean) and pulmonary capillary wedge pressure (PCWP), divided by the cardiac output (CO). PVR and PAPmean are acquired during a right heart catheterization. CO is a calculated hemodynamic parameter, too. Formula: PVR = 80*(PAPmean - PCWP)/CO|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.||dyn*s*cm^-5||Standard Deviation|Mean
811391|NCT01065454|Secondary|Venous Oxygen Saturation (SvO2) - Change From Baseline to Week 16|The mixed venous oxygen saturation rate (SvO2) is a directly measured hemodynamic parameter. SvO2 is recorded during a right heart catheterization.|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.||Percentage||Standard Deviation|Mean
826176|NCT01196104|Secondary|Number of Subjects Reporting Cough Episodes|Number of Subjects Reporting Cough Episodes|Baseline to Week 16|Safety Population||Number of participants|||Number
811392|NCT01065454|Primary|Pulmonary Artery Mean Pressure (PAPmean) at Rest - Change From Baseline to Week 16|Mean pulmonary arterial pressure (PAPmean) is a directly measured hemodynamic parameter. PAPmean is recorded during a right heart catheterization.|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF [safety analysis set]/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.||mmHg||Standard Deviation|Mean
811393|NCT01065506|Primary|Percentage of Participants Who Abstained From Smoking at 10 and 30 Weeks Post Quit Day|Point Prevalence Abstinence (PPA) was defined as not smoking [even a single puff] at the end of treatment and/or on the day of follow-up|End of treatment (10 weeks post quit day) and 30-week follow-up|Participants who completed the end of treatment assessment||number of participants|||Number
811394|NCT01065558|Secondary|Decrease in Self-injurious Behavior at End of Study (Two Weeks After Screening) Compared to Screening|Change in the self-injurious subscale of the Behavior Problems Inventory (BPI). the BPI is a well-validate test to evaluate the frequency and severity of a patient's self-injurious behavior. Values range from 0 to 50, and a low score means few/less severe behaviors|Screening visit and end of study (two weeks)|All patients who received any dose of ecopipam were in the analysis population||Change in BPI score||Standard Deviation|Mean
811395|NCT01065558|Primary|Number of Participants With Clinically Significant Changes in Standard Laboratory Tests|This study’s primary outcome is the safety of ecopipam in Lesch-Nyhan patients as measured by standard clinical laboratory tests. The patients will also be observed and questioned about other side effects, such as whether they feel more or less tired.Standard clinical laboratory tests for liver, kidney and blood function were conducted. The normal ranges for each of these tests were different and are too numerous to be individually listed here. However, if any individual value were to be either three-times greater or lesser than the upper or the lower limit of the test, then that value was considered to have been changed.|Two weeks|All patients were analyzed||Participants|||Number
811396|NCT01065597|Secondary|Change in Brain-derived Neurotrophic Factor (BDNF) Blood Level|Change in plasma level of BDNF in pg/ml pre and post NET treatment course.|Baseline and at the end of the NET treatment course 2-4 weeks later, depending on the number of NET treatments|2 subjects had a seizure during the first treatment and therefore had no seizure-free (nonconvulsive) data, and 2 subjects declined blood draw||pg/ml||Full Range|Median
811397|NCT01065597|Secondary|Change in Score on the Autobiographical Memory Inventory Short Form (AMI-S)|The Autobiographical Memory Inventory Short Form (AMI-S ) assesses effects on retrograde memory for autobiographical information including information related to a family member, recent travel, events of last New Year's eve, events of last birthday, employment information, and events of last non-psychiatric illness and its treatment. Subjects responded to specific questions regarding these topics before and after their course of NET treatment. Subjects were scored based on the percent of responses post-NET treatment that correctly matched their responses prior to NET treatment. The score range is 0 to 100%. The higher the percent, the less impaired is the autobiographical memory.|Baseline and at the end of the NET treatment course 2-4 weeks later, depending on the number of NET treatments|2 of 13 subjects had seizures during first treatment; therefore, there are no seizure-free data for them that would qualify as nonconvulsive treatment data||% correct responses||Standard Deviation|Mean
811398|NCT01065597|Secondary|Change in Score on Mini-mental State Exam|Score range is 0 to 30 points. The higher the score, the better the cognition. So a higher score means less cognitive impairment.|Baseline and at the end of the NET treatment course 2-4 weeks later, depending on the number of NET treatments|2 of 13 subjects had seizures during first treatment; therefore, there are no seizure-free data for them that would qualify as nonconvulsive treatment data||units on a scale||Standard Deviation|Mean
811399|NCT01065597|Primary|Change in Score on the 17-item Hamilton Depression Rating Scale|Score range is 0 to 54 points. The higher the score, the more depressed symptoms.|Baseline and at the end of the NET treatment course 2-4 weeks later, depending on the number of NET treatments|2 of 13 subjects had seizures during first treatment; therefore, there are no seizure-free data for them that would qualify as nonconvulsive treatment data||units on a scale||Standard Deviation|Mean
811400|NCT01065714|Secondary|Percentage of Participants With an Increase in Skin Hydration Using Hydrogel Vehicle on Targeted Area of One Half of Body.|Five timed readings at (0, 15, 30, 45 and 60 minutes) were taken, using the Corneometer 825 meter, on participants using Hydrogel vehicle|Baseline to 14 days|per protocol||percentage of participants||Standard Deviation|Mean
811401|NCT01065714|Secondary|Percentage of Participants With an Increase in Skin Hydration Using Eucerin Lotion on Targeted Area on One Half of Body|Five timed readings ( 0, 15, 30, 45 and 60 minutes) were taken using the Corneometer 825 meter on subjects using Eucerin lotion on targeted area on one half of body|Baseline to 14 days|per protocol||Percentage of participants||Standard Deviation|Mean
811402|NCT01065714|Primary|Percent Change of Trans Epidural Water Loss (TEWL) With the Use of Hydrogel Vehicle|The average of three sequential Tewameter 300 meter readings taken at a minimum of one minute intervals on target areas of body half treated with Hydrogel vehicle|Day 1 to Day 14|Per protocol||percent change||Full Range|Median
811403|NCT01065714|Primary|Percent Change of Trans Epidermal Water Loss (TEWL) With Use of Eucerin Lotion|The average of three sequential Tewameter 300 meter readings taken at a minimum of one minute intervals on targeted area of body half treated with Eucerin lotion|Day 1 to Day 14|per protocol||percent change||Full Range|Median
811404|NCT01065766|Primary|Percentage of Participants With an Overall Efficacy Evaluation by the Investigator of Improved, Stable, or Worse at Week 24|"Overall efficacy analysis was conducted on participants who have used study drug for more than 24 weeks and whose improvement of the disease has been assessed by Principal investigator. The investigator's global assessment of disease improvement was classified as either: Improved, Stable and Worse in a Medical History/Physical Examination form."|At Week 24|Participants who have used study drug for more than 24 weeks and whose improvement of the disease has been assessed by Principal investigator.||Percentage of participants|||Number
811405|NCT01065766|Primary|Change From Baseline in 2hr-PPG at Week 24|Blood glucose was measured 2 hours after a meal (2hr-PPG). 2hr-PPG is expressed as mg/dL. Therefore, this change from baseline reflects the Week 24 2hr-PPG minus Week 0 2hr-PPG.|Baseline and Week 24|Participants with a pre-treatment and a 24-week post-treatment measurement of 2hr-PPG.||mg/dL||Standard Deviation|Mean
831855|NCT01243320|Primary|Change In CreatinineBlood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days|||mg/dL||95% Confidence Interval|Mean
811407|NCT01065766|Primary|Change From Baseline to Treatment in HbA1c at Week 24|HbA1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%). Therefore, this change from baseline reflects the Week 24 A1C minus Week 0 A1C.|Baseline and Week 24|All participants with a pre-treatment and a 24-week post-treatment HbA1c value.||Percentage of glycosylated hemoglobin||Standard Deviation|Mean
811408|NCT01065766|Primary|Percentage of Participants With an Overall Efficacy Evaluation by the Investigator of Improved, Stable, or Worse at Week 12|"Overall efficacy analysis was conducted on participants who have used study drug for more than 12 weeks and whose improvement of the disease has been assessed by Principal investigator. The investigator's global assessment of disease improvement was classified as either: Improved, Stable and Worse in a Medical History/Physical Examination form."|At Week 12|Participants who have used study drug for more than 12 weeks and whose improvement of the disease has been assessed by Principal investigator.||Percentage of participants|||Number
811409|NCT01065766|Primary|Change From Baseline in 2-hour Post Prandial Glucose (2hr-PPG) at Week 12|Blood glucose was measured 2 hours after a meal (2hr-PPG). 2hr-PPG is expressed as mg/dL. Therefore, this change from baseline reflects the Week 12 2hr-PPG minus Week 0 2hr-PPG.|Baseline and Week 12|Participants with a pre-treatment and a 12-week post-treatment measurement of 2hr-PPG.||mg/dL||Standard Deviation|Mean
811410|NCT01065766|Primary|Change From Baseline to Treatment in Fasting Plasma Glucose (FPG) at Week 12|Blood glucose was measured on a fasting basis (collected after an 8- to 10-hour fast). FPG is expressed as mg/dL. Therefore, this change from baseline reflects the Week 12 FPG minus Week 0 FPG.|Baseline and Week 12|Participants with a pre-treatment and a 12-week post-treatment measurement of FPG.||mg/dL||Standard Deviation|Mean
811411|NCT01065766|Primary|Change From Baseline to Treatment in Hemoglobin HbA1c (A1C) at Week 12|HbA1C is found when high blood levels of glucose combines with hemoglobin to form glycated hemoglobin. The average amount of glucose in blood over a prolonged periods of time can be determined by measuring a hemoglobin A1c level which is reported as a percentage (%). The change from baseline reflects the Week 12 A1C minus Week 0 A1C.|Baseline and Week 12|All participants with a pre-treatment and a 12-week post-treatment HbA1c value.||Percentage of glycosylated hemoglobin||Standard Deviation|Mean
811412|NCT01065766|Primary|Percentage of Participants With Any Adverse Experience|An adverse event (AE) is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.|Up to 26 weeks|All participants who were included in the safety evaluation||Percentage of participants|||Number
811413|NCT01065779|Primary|Change From Baseline in Alkaline Phosphatase at End of Treatment|For efficacy evaluation, changes in Serum Alkaline Phosphatase were evaluated before study drug administration and at end of study drug treatment. Change was calculated as the later time point (at ~16 weeks) minus the earlier time point (baseline). The Last Observation Carried Forward (LOCF) method was used. That is, the last observed non-missing value was used to fill in missing values at the later point in the study.|Baseline and End of Treatment (Up to ~ 16 weeks)|Among 798 participants in safety evaluation, there was a total of 789 participants for efficacy evaluation excluding 8 participants who took study drug for < 4 weeks and 1 participant who did not enter efficacy evaluation. Only participants with lab values submitted to Sponsor were included.||mg/dL||Standard Deviation|Mean
811414|NCT01065779|Primary|Change From Baseline in Urine Deoxypyridinoline at End of Treatment|For efficacy evaluation, changes in Serum Deoxypyridinoline were evaluated before study drug administration and at end of study drug treatment. Change was calculated as the later time point (at ~16 weeks) minus the earlier time point (baseline). The Last Observation Carried Forward (LOCF) method was used. That is, the last observed non-missing value was used to fill in missing values at the later point in the study.|Baseline and End of Treatment (Up to ~ 16 weeks)|Among 798 participants in safety evaluation, there was a total of 789 participants for efficacy evaluation excluding 8 participants who took study drug for < 4 weeks and 1 participant who did not enter efficacy evaluation. Only participants with lab values submitted to Sponsor were included.||nmol/mmol||Standard Deviation|Mean
811415|NCT01065779|Primary|Change From Baseline in Serum Osteocalcin at End of Treatment|For efficacy evaluation, changes in Serum Osteocalcin were evaluated before study drug administration and at end of study drug treatment. Change was calculated as the later time point (at ~16 weeks) minus the earlier time point (baseline). The Last Observation Carried Forward (LOCF) method was used. That is, the last observed non-missing value was used to fill in missing values at the later point in the study.|Baseline and End of Treatment (Up to ~ 16 weeks)|Among 798 participants in safety evaluation, there was a total of 789 participants for efficacy evaluation excluding 8 participants who took study drug for < 4 weeks and 1 participant who did not enter efficacy evaluation. Only participants with lab values submitted to Sponsor were included.||ng/mL||Standard Deviation|Mean
811416|NCT01065779|Primary|Change From Baseline in Serum 25-hydroxyvitamin D at End of Treatment|For efficacy evaluation, changes in Serum 25-hydroxyvitamin D were evaluated before study drug administration and at end of study drug treatment. Change was calculated as the later time point (at ~16 weeks) minus the earlier time point (baseline). The Last Observation Carried Forward (LOCF) method was used. That is, the last observed non-missing value was used to fill in missing values at the later point in the study.|Baseline and End of Treatment (Up to ~ 16 weeks)|Among 798 participants in safety evaluation, there was a total of 789 participants for efficacy evaluation excluding 8 participants who took study drug for < 4 weeks and 1 participant who did not enter efficacy evaluation. Only participants with lab values submitted to Sponsor were included.||ng/mL||Standard Deviation|Mean
811417|NCT01065779|Primary|Number of Participants With Improved, Unchanged, or Worsened Disease|"Evaluation of disease improvement was conducted in 3 categories of improved, unchanged, or worsened. Changes in biochemical markers and vitamin D levels were reviewed before (baseline) and after treatment using statistical analyses to determine disease status, which was reported as either improved, unchanged, or worsened."|Baseline and end of Treatment (Up to ~ 16 weeks)|Among 798 participants in safety evaluation, there was a total of 789 participants for efficacy evaluation excluding 8 participants who took study drug for < 4 weeks and 1 participant who did not enter efficacy evaluation.||Participants|||Number
811545|NCT01067105|Secondary|Percentage of Subjects Experiencing Local Nasal AEs|Local Nasal adverse events are defined as adverse events occurring in the middle ear, nose, throat, and upper respiratory tract down to the larynx, anatomic regions.|Weeks 1-26|Intent to Treat Population||percentage of participants|||Number
811418|NCT01065779|Primary|Number of Participants With Non-Serious AEs|An AE was defined as any unfavorable & unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the product, was also considered an AE. There was no required routine visit scheduled for AE assessment. AEs were collected through participant self-reporting and assessed by investigators.|Up to ~ 16 weeks and 14 days after treatment discontinuation|Safety evaluation was performed in participants who took at least one dose of study medication and completed > 1 follow up visit.||Participants|||Number
811419|NCT01065779|Primary|Number of Participants With Unexpected Adverse Events|Number of participants that experienced unexpected Adverse Events (AEs) regardless of whether or not the AE was considered related to the use of the product. There was no required routine visit scheduled for AE assessment. An AE was defined as any unfavorable & unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product. Any worsening (any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the product, was also considered an AE.|Up to ~ 16 weeks and 14 days after treatment discontinuation|Safety evaluation was performed in participants who took at least one dose of study medication and completed > 1 follow up visit.||Participants|||Number
811420|NCT01065779|Primary|Number of Participants With Serious Adverse Events|"Number of participants that experienced Serious Adverse events (SAE). There was no required routine visit scheduled for AE assessment. AEs were collected through participant self-reporting and assessed by investigators.
SAEs were considered serious if the event resulted in:
death or was life-threatening
prolonged an existing inpatient hospitalization
a persistent or significant disability/ incapacity
a congenital anomaly/ birth defect
a significant medical situation, other important medical event based upon appropriate medical judgment of the investigator"|Up to ~ 16 weeks and 14 days after treatment discontinuation|Safety evaluation was performed in participants who took at least one dose of study medication and completed > 1 follow up visit.||Participants|||Number
811421|NCT01065818|Primary|Optimal Timepoint During the Course of Neoadjuvant Therapy [CRT, CT (Chemotherapy) or RT Radiotherapy)] That FLT-PET Imaging Can Predict Response||2.5 months|Due to poor enrollment, data was not analyzed. Adequate data was not collected and the only type of data that remained available was the total # enrolled, some information of the population demographics, and AE/SAE logs that were submitted to the IRB for review.|||||
811422|NCT01065844|Secondary|Quality of Life|Quality of life as measured by the EORTC QLQ-C30 survey|every 1 to 3 months||||||
811423|NCT01065844|Primary|Tumor Progression|Tumor progression as defined by RECIST version v1.1 criteria with ordinal measurements of complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD).|Every 1 to 3 months|Those with adverse events necessitating interruption of intervention and removal from study were not assessed for outcome measures||Participants|||Count of Participants
811424|NCT01066000|Secondary|Number of Participants With Marked Laboratory Abnormalities|A marked laboratory abnormality is defined as above and/or below the normal range of a laboratory parameter which was considered to be potentially clinically relevant. The number of participants with marked laboratory abnormality are presented. Marked laboratory abnormalities were analyzed according to the Roche specified limits for the following reference range: Haemoglobin (Hb) (11.7-17.3 g/dL), Haematocrit (Hct) (35-47%), White blood cells (WBC) (3.6-11.0 10^3/µL), Red blood cells (RBC) (3.8– 5.9 10^6/µL), MCV (80-100 fL) Platelets (150-440 10^3/µL), Iron (37-158 µg/dL), Ferritin (10-365 ng/mL), Transferrin (170-340 mg/dL), TIBC (250-450 µg/dL), TSAT (15-50%), Albumin (3.4-4.8 g/dL), hs-CRP (<= 10.000 mg/dL), Potassium (3.5-5.1 mmol/L), and Phosphorus (2.7-4.5 mg/dL).|Up to Week 28|Safety population included all participants who entered into the study and took at least one dose of study drug.The ITT and safety population were identical. Data of maximum number of participants (33 participants) available at the time of analysis were analysed and reported.||Participants|||Number
811425|NCT01066000|Secondary|Mean Monthly Dose of Methoxy Polyethylene Glycol-epoetin Beta During the Dose Titration and Evaluation Periods|Mean monthly dose of methoxy polyethylene glycol-epoetin beta during the dose titration and evaluation periods was assessed and reported.|Baseline, Week 4, Week 8, Week 12, Week 16, and Week 20|ITT population was defined as all participants who entered into study and took at least one dose of study drug. The ITT and safety population were identical. Data of maximum number of participants (24 participants) available at the time of analysis were analysed and 9 participants discontinued the study before this analysis.||μg/month||Standard Deviation|Mean
811426|NCT01066000|Secondary|Mean Number of Months Per Participant Requiring Dose Adjustment During the Dose Titration and Evaluation Periods|Mean number of months per participant requiring dose adjustment during the dose titration and evaluation periods was assessed and reported.|Up to Week 24|ITT population was defined as all participants who entered study and took at least one dose of study drug. The ITT and safety population were identical. At Week 24, data of 24 participants were included whereas 9 participants were excluded from the analysis as they discontinued the study before analysis of this outcome measure.||Months||Standard Deviation|Mean
811427|NCT01066000|Secondary|Mean Time Spent by Participants in the Haemoglobin Range of 10 – 12 g/dL During the Efficacy Evaluation Period|Mean time spent in the haemoglobin range 10 – 12 g/dL during the efficacy evaluation period (EEP) was assessed and reported.|Up to Week 24|ITT population was defined as all participants who entered study and took at least one dose of study drug. The ITT and safety population were identical. At Week 24, data of 24 participants were included whereas 9 participants were excluded from the analysis as they discontinued the study before analysis of this outcome measure.||Weeks||Standard Deviation|Mean
811428|NCT01066000|Secondary|Proportion of Participants Maintaining Haemoglobin Concentration Within the Haemoglobin Range 10-12g/dL Throughout the Efficacy Evaluation Period|The proportion of participants maintaining haemoglobin concentration within the haemoglobin range 10-12g/dL throughout the efficacy evaluation period (EEP) was assessed and reported.|Up to Week 24|ITT population was defined as all participants who entered study and took at least one dose of study drug. The ITT and safety population were identical. At Week 24, data of 24 participants were included whereas 9 participants were excluded from the analysis as they discontinued the study before analysis of this outcome measure.||Percentage of participants|||Number
811546|NCT01067105|Primary|Percentage of Subjects Who Discontinue Due to AEs.||Weeks 1-26|Intent to Treat Population||percentage of participants|||Number
811429|NCT01066000|Secondary|Mean Change in Haemoglobin Concentration From Screening Period and Efficacy Evaluation Period|The mean haemoglobin (Hb) concentration (g/dL) change from the baseline (Week 0) till efficacy evaluation period (EEP) was assessed and reported.|Up to Week 24|ITT population was defined as all participants who entered study and took at least one dose of study drug. The ITT and safety population were identical. At Week 24, data of 24 participants were included whereas 9 participants were excluded from the analysis as they discontinued the study before analysis of this outcome measure.||g/dL||Standard Deviation|Mean
811430|NCT01066000|Secondary|Number of Participants With Adverse Events and Serious Adverse Events|An adverse event (AE) was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A Serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. The AEs were assessed from baseline to every visit throughout the treatment, post study drug discontinuation, and follow up period.|Up to Week 28|Safety population included all participants who entered into the study and took at least one dose of study drug.The ITT and safety population were identical. Data of maximum number of participants (33 participants) available at the time of analysis were analysed and reported.||Participants|||Number
811431|NCT01066000|Primary|Proportion of Participants Maintaining Average Haemoglobin During the Efficacy Evaluation Period Within the Target Range (10-12 g/dl)|The proportion of participants with their mean haemoglobin (Hb) concentration (g/dL) within the target range during the efficacy evaluation period was assessed. The target range is the reference Hb not >12 g/dL and not < 10 g/dL.|Up to Week 24|Intent to treat (ITT) population was defined as all participants who entered study and took at least one dose of study drug. The ITT and safety population were identical. At Week 24, data of 24 participants were included whereas 9 participants were excluded from the analysis as they discontinued the study before analysis of this outcome measure.||Percentage of participants|||Number
811432|NCT01066039|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An Adverse Event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A Serious Adverse Event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.|Baseline up to Month 6|Safety population included all participants who received at least one dose of investigational product.||participants|||Number
811433|NCT01066039|Secondary|Change From Baseline in Microalbumin Level at Month 6|The change in microalbumin level at Month 6 was calculated as microalbumin level at Month 6 minus microalbumin level at baseline.|Baseline, Month 6|"FAS included all participants who took the investigational product at least once and for whom the primary efficacy endpoint (HbA1c) was measured. Here, N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and n signifies those participants who were evaluable for the specified category."||mg/dL||Standard Deviation|Mean
811434|NCT01066039|Secondary|Change From Baseline in Albumin/Creatinine Ratio at Month 6|The change in albumin/creatinine ratio at Month 6 was calculated as albumin/creatinine ratio at Month 6 minus albumin/creatinine ratio at baseline.|Baseline, Month 6|"FAS included all participants who took the investigational product at least once and for whom the primary efficacy endpoint (HbA1c) was measured. Here, N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and n signifies those participants who were evaluable for the specified category."||ratio||Standard Deviation|Mean
811435|NCT01066039|Secondary|Change From Baseline in Total Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL) Cholesterol and Triglyceride Level at Month 6|The change in total cholesterol, low density lipoprotein (LDL) cholesterol, high density lipoprotein (HDL) cholesterol, and triglyceride levels at Month 6 was calculated as total cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride levels at Month 6 minus total cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride levels at baseline, respectively.|Baseline, Month 6|"FAS included all participants who took the investigational product at least once and for whom the primary efficacy endpoint (HbA1c) was measured. Here, N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and n signifies those participants who were evaluable for the specified category."||milligram per deciliter (mg/dL)||Standard Deviation|Mean
811436|NCT01066039|Secondary|Change From Baseline in C-Peptide Level at Months 3 and 6|The change in C-peptide level at Months 3 and 6 was calculated as C-peptide level at Months 3 and 6 minus C-peptide level at baseline.|Baseline, Months 3 and 6|FAS included all participants who took the investigational product at least once and for whom the primary efficacy endpoint (HbA1c) was measured.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
811437|NCT01066039|Secondary|Change From Baseline in Insulin Level at Months 3 and 6|The change in insulin level at Months 3 and 6 was calculated as insulin level at Months 3 and 6 minus insulin level at baseline.|Baseline, Months 3 and 6|FAS included all participants who took the investigational product at least once and for whom the primary efficacy endpoint (HbA1c) was measured.||mcIU/mL||Standard Deviation|Mean
811438|NCT01066039|Secondary|Change From Baseline in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) at Months 3 and 6|HOMA-IR is as an indicator of insulin resistance in participants with Type 2 diabetes mellitus and comorbid hypertension. HOMA-IR was derived from fasting plasma glucose (FPG) and fasting insulin (FI) using the formula: (FI [micro international units per milliliter {mcIU/mL}] * FPG [millimole per liter {mmol/L}]) divided by 22.5. The change in HOMA-IR at Months 3 and 6 was calculated as HOMA-IR at Months 3 and 6 minus HOMA-IR at baseline.|Baseline, Months 3 and 6|FAS included all participants who received at least one dose of investigational product and for whom the primary efficacy endpoint (HbA1c) was measured.||mcIU/mL * mmol/L||Standard Deviation|Mean
811439|NCT01066039|Secondary|Change From Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and Mean Blood Pressure (BP) at Month 6|The change in SBP, DBP, and mean BP at Month 6 were calculated as SBP, DBP, and mean BP at Month 6 minus SBP, DBP, and mean BP at baseline, respectively. Mean BP was calculated using the formula: (DBP plus [{SBP minus DBP} divided by 3]).|Baseline, Month 6|FAS included all participants who received at least one dose of investigational product and for whom the primary efficacy endpoint (HbA1c) was measured.||mmHg||Standard Deviation|Mean
811440|NCT01066039|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Month 3|HbA1c represents the percentage of glycosylated hemoglobin. The change in HbA1c at Month 3 was calculated as HbA1c at Month 3 minus HbA1c at baseline.|Baseline, Month 3|FAS included all participants who received at least one dose of investigational product and for whom the primary efficacy endpoint (HbA1c) was measured.||Percent HbA1c||Standard Deviation|Mean
811441|NCT01066039|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Month 6|HbA1c represents the percentage of glycosylated hemoglobin. The change in HbA1c at Month 6 was calculated as HbA1c at Month 6 minus HbA1c at baseline.|Baseline, Month 6|Full analysis set (FAS) included all participants who received at least one dose of investigational product and for whom the primary efficacy endpoint (HbA1c) was measured.||Percent HbA1c||Standard Deviation|Mean
811442|NCT01066104|Secondary|Objective (b) the Effect on Volume of Polypoid Mucosal Tissue in the Nose and Sinuses on Rhinoscopic Examination.|"Improvement is defined as any reduction in the total nasal polyp score. Using rhinoscopic evaluation, Nasal Polyp Score will be assessed on the right and on the left, and added together.
Scoring system:
Score Definition 0 No polyps
Polyp in middle meatus, not reaching below the inferior border of the middle turbinate
Polyp reaching below the inferior border of the middle turbinate but not touching the inferior turbinate
Polyp reaching below the inferior border of the middle turbinate and touching the inferior turbinate
Polyp reaching to or below the lower border of the inferior turbinate
Range: minimum 0 (better outcome), maximum 8 (worse outcome)"|4 months|||Change in Total polyp score||Standard Deviation|Mean
811443|NCT01066104|Primary|Objective (a) the Effect on Polypoid Mucosal Thickening in the Anterior Ethmoid and Maxillary Sinuses as Measured on Sinus CT Scan.|"Improvement is defined as any decrease in sinus CT scores at end of study.
Quantification of polypoid mucosal thickening in the anterior ethmoid and maxillary sinuses on sinus CT scan (primary outcome variable):
A sinus CT scan will be performed on Day 0 and repeated on Day 112. The CT scans will be performed with consistent orientation of the patient’s head and landmarks to assure that both the pretreatment and posttreatment scans are done with identical orientation and sections. The CT scans will be scored using the established scoring system known as the Zinreich modification of the Lund Mackay scoring system.. As an exploratory measure, a 3-dimensional scoring system developed with the radiology department of Massachusetts General Hospital may also be used."|4 months|||% Change||Standard Deviation|Mean
811444|NCT01066143|Primary|Change From Baseline in GAD Symptomatology at the Week 12 Timepoint.|Changes in anxiety symptomatolgy|12 week|8 subjects signed the consent but were later found to be ineligible; the study didn't start|||||
811445|NCT01066156|Primary|Change From Baseline in PTSD Symptomatology at the Week 8 Timepoint.|"We will compare patients' symptomatology at baseline vs. at 8 week timepoint
Specify Full Scale Name and Construct (i.e., indicate what the scale measures if not clear from name): Clinician-Administered PTSD Scale (CAPS)
Include all scale ranges (i.e., minimum and maximum scores) required to interpret any values in the data table: 0-136
For each scale range provided, specify which values are considered to be a better or worse outcome: 0-best, 136 worst
If subscales are combined to compute a total score, consider indicating how subscales are combined (summed, averaged, etc.): summed"|8 weeks|It was predicted that patients will show a change in PTSD symptoms as measured by the Clinician Administered PTSD Scale (CAPS).||units on a scale||Standard Deviation|Mean
811446|NCT01066520|Primary|Patient's Assessment of Ankle Pain (VAS)- Percentage Decrease on Day 7|"Pain evaluated by a 100 mm visual analogue scale (VAS) where 0 means no pain and 100 means the highest, unbearable pain. The absolute values of VAS have been the basis of analysis.
The highest is the change in negative, the better are the results in percentages."|From baseline (day 1) visit to day 7|||Percentage change in scale VAS||Inter-Quartile Range|Median
811447|NCT01066520|Secondary|Global Judgment of Efficacy||Day 14||||||
811448|NCT01066520|Secondary|Time to Normal Function (Training/Sports)||Day 1 to 4, 7, 14, 42||||||
811449|NCT01066520|Secondary|Physician's Assessment of Normal Function/Activity (5-point-scale)||Day 1 to 4, 7, 14, 42||||||
811450|NCT01066520|Secondary|Swelling ('Figure-of-eight')||Day 1 to 4,7,14||||||
811451|NCT01066520|Secondary|FAAM Sports Subscale||Day 1 to 4, 7, 14, 42||||||
811452|NCT01066520|Secondary|FAAM ADL Subscale||Day 1 to 4, 14, 42||||||
811453|NCT01066520|Primary|Change of the Foot and Ankle Ability Measurement (FAAM), Activity of Daily Living Subscale (ADL) From Baseline to Day 7|"The Foot and Ankle Ability Measure (FAAM) is a self-report outcome instrument developed to assess physical function for individuals with foot and ankle related impairments. The Foot and Ankle Ability Measure is a 29-item questionnaire divided into two subscales: the Foot and Ankle Ability Measure, 21-item Activities of Daily Living Subscale and the Foot and Ankle Ability Measure, 8-item Sports Subscale.
Each item is scored on a 5-point Likert scale (4 to 0) from ‘no difficulty at all’ (score 4), ´slight difficulty´, ´moderate difficulty´, éxtreme difficulty´ to ‘unable to do’ (score 0). Responses marked as ´not applicable´were not counted.
Item score totals, which range from 0 to 84 for the ADL subscale and 0 to 32 for the Sports subscale, were transformed to percentage scores. Higher scores represent higher levels of function for each subscale, with 100% representing no dysfunction."|Day 1 to day 7|Changes to Baseline: absolute values. Primary analyses were based on the Intent-To-Treat sample. Only patients with intial VAS<30 mm were excluded from the analysis set. Missing data were handled by the ‘Last Observation Carried Forward’ method.||Scores on a scale||Inter-Quartile Range|Median
811454|NCT01066520|Primary|Patient's Assessment of Ankle Pain (VAS)- Absolute Value Decrease on Day 7|"Pain evaluated by a 100 mm visual analogue scale (VAS) where 0 means no pain and 100 means the highest, unbearable pain. The absolute values of VAS have been the basis of analysis.
The highest is the change in negative, the better are the results in absolute values."|From baseline (day 1) visit to day 7|Changes from baseline at day7: absolute values and in percentage. Primary analyses were based on the Intent-To-Treat sample. Only patients with intial VAS<30 mm were excluded from the analysis set. Missing data were handled by the 'Last Observation Carried Forward' method.||Absolute value units on a scale VAS||Inter-Quartile Range|Median
811526|NCT01066871|Primary|Percent Change From Baseline in Cartilage Defect Volume at Month 12|Percent change in cartilage defect volume was calculated based on central magnetic resonance imaging (MRI): (volume at Month 12 minus volume at baseline)*100/volume at baseline.|Baseline, Month 12|"The modified intent-to-treat (mITT) analysis set included all participants from the ITT analysis set who had at least 1 post-treatment magnetic resonance imaging assessment. N (number of participants analyzed) signifies the participants who were evaluable for this outcome measure."||Percent change||Standard Deviation|Mean
811455|NCT01066546|Secondary|Change From Baseline in European Quality of Life 5 Domain Scale (EQ-5D) at Week 12 and 16|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Total possible score is sum of individual items, ranged from 5 to 15; lower score indicated a better health state."|Baseline, Week 12, 26|Data was not analyzed due to early termination of study and no participants completed the pre-defined visit schedule.|||||
811456|NCT01066546|Secondary|Change From Baseline in Resource Utilization in Dementia - Lite Version (RUD-Lite) at Week 12 and 26|RUD Lite: instrument used to assess amount of both formal and informal resources used by demented participants and primary caregiver. It was completed by caregivers and compiles data on following resources: use of social services, frequency and duration of hospitalizations, all contacts with health care professionals, participant living accommodations, amount of time the caregiver spends giving care and the impact of care giving on the caregiver’s job. Overall cost of care was evaluated to quantify the resources utilized.|Baseline, Week 12, 26|Data was not analyzed due to early termination of study and no participants completed the pre-defined visit schedule.|||||
811457|NCT01066546|Secondary|Sum of Delusions and Hallucinations Sub-domain Scores of Neuropsychiatric Inventory (NPI) at Week 26|NPI is a 12-domain caregiver assessment of behavioral disturbances occurring in dementia. Severity (1=Mild to 3=Severe) and frequency (1=occasionally to 4=very frequently) scales were recorded separately for each domain and their product gives individual domain score (range 0-12). Sum of delusions and hallucinations sub-domain scores of NPI was calculated as a measure of Alzheimer’s Disease (AD) related psychosis. Total possible score range: 0-24 with higher score indicating greater behavioral disturbances.|Week 26|Data was not analyzed due to early termination of study and no participants completed the pre-defined visit schedule.|||||
811458|NCT01066546|Secondary|Change From Baseline in Neuropsychiatric Inventory (NPI) at Week 6, 12 and 26|NPI:12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, nighttime behavior. Severity(1=Mild to 3=Severe),frequency(1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score(range 0-12). Total score=sum of each domain score(range 0-144);higher score=greater behavioral disturbances;negative change score from baseline=improvement.|Baseline, Week 6, 12, 26|Data was not analyzed due to early termination of study and no participants completed the pre-defined visit schedule.|||||
811459|NCT01066546|Secondary|Change From Baseline in Mini-Mental State Examination (MMSE) at Week 12 and 26|MMSE measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. Total score derived from sub-scores; ranged from 0 to 30, higher score indicates better cognitive state.|Baseline, Week 12, 26|Data was not analyzed due to early termination of study and no participants completed the pre-defined visit schedule.|||||
811460|NCT01066546|Secondary|Change From Baseline in Alzheimer’s Disease Cooperative Study–Activities of Daily Living-Severe Version (ADCS-ADLsev) at Week 6, 12 and 26|ADCS-ADLsev: 19-item scale measures basic and instrumental abilities in participant population and had good metric properties and reliability in detecting change. Individual score range: 0 to 5 for telephone, 0 to 4 for dressing, watch television, get around outside home, 0 to 3 for eating, walking, toilet, bathing, grooming, conversation/small talk, clear dishes, find personal belongings, obtain beverages, dispose of garbage, left on own, 0 to 1 for run water from and turn off faucet to wash hands, turn on and off light. Total score range: 0 to 54 lower scores=greater functional impairment.|Baseline, Week 6, 12, 26|Data was not analyzed due to early termination of study and no participants completed the pre-defined visit schedule.|||||
811461|NCT01066546|Secondary|Change From Baseline in Severe Impairment Battery (SIB) at Week 6, 12 and 26|SIB developed for evaluation of cognitive function in participants, who demented to a degree that they cannot complete conventional neuropsychological testing. Test items consisted of simple, one-step commands presented with gestural cues and instructions that were repeated if necessary. SIB test consisted of 51-item scale, divided into 9 subscales: social interaction (0-6), memory (0-14), orientation (0-6), language (0-46), attention (0-6), praxis (0-8), visuospatial ability (0-8), construction(0-4), orienting to name(0-2). Total possible score:0-100; lower score=greater cognitive impairment.|Baseline, Week 6, 12, 26|Data was not analyzed due to early termination of study and no participants completed the pre-defined visit schedule.|||||
811462|NCT01066546|Primary|Number of Participants With Adverse Events (AEs)|An adverse event is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|Baseline up to 4 weeks after last dose of study treatment|Safety analysis population included all enrolled participants who received at least 1 dose of study treatment, including partial doses.||participants|||Number
811463|NCT01066585|Secondary|Summary of the Reported Skin/Scalp Irritation Before Treatment and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)|"Severe skin/scalp irritations were defined as follows:
Severe Pruritus - Nearly constant, frequent scratching, very bothersome; Severe Erythema - large areas of the scalp are red; Severe Excoriation - Widespread breaking of the skin involving most of the scalp; Severe Pyoderma - Lesions with crusting or other evidence of infection, involving most of the scalp."|Day 1 up to Day 15 post-application|Skin/scalp irritation was assessed in the Intent-to-treat (Safety) population.||Participants|||Number
811464|NCT01066585|Secondary|Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control)|"Severity of the adverse events were defined and classified as follows:
'Mild' - Awareness of signs or symptoms, but easily tolerated; 'Moderate' - Discomfort to a degree that adverse event/adverse drug reaction causes interference with normal daily life activities and/or requires medication; 'Severe' - Incapacity with regard to work or usual daily life activities. Requires medical attention/intervention."|Day 1 up to Day 15 post-application.|Adverse events were assessed in the Intent-to-treat (Safety) population.||Participants|||Number
811527|NCT01066897|Secondary|Mesolimibic Reward Activity Baseline Differences in Depression vs Healthy Controls|Because of the small number of depressed patients and noisy/unusable data, analyses were not run.|Baseline|Because of the small number of depressed patients and noisy/unusable data, analyses were not run.|||||
811465|NCT01066585|Secondary|Percentage of All Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 15 Post-treatment With Either Ivermectin or Placebo (Vehicle Control)|Treatment success, defined as absence of live lice, was assessed in all subjects. Treatment success was assessed by last observation carried forward (LOCF) imputation and treatment failure imputation.|Day 2 up to Day 15 post-application|Treatment success was assessed in the Intent-to-treat population. Any participant with live lice on or after Day 2 received an FDA approved head lice treatment and was classified as a treatment failure, imputed as such for remaining assessments.||Percent of Participants|||Number
811466|NCT01066585|Primary|Percentage of Index Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 15 Post-treatment With Either Ivermectin or Placebo (Vehicle Control)|Treatment success defined as absence of live lice, was assessed in index participants, defined as the youngest person within each household who had at least 3 live lice present at Screening (Day 1). Treatment success was assessed by last observation carried forward (LOCF) imputation and treatment failure imputation.|Day 2 up to Day 15 post-application|Treatment success was assessed in the Intent-to-treat population. Any participant with live lice on or after Day 2 received an FDA approved head lice treatment and was classified as a treatment failure, imputed as such for remaining assessments.||Percent of Participants|||Number
811467|NCT01066624|Primary|Incidence of Oral Mucositis|Incidence of grade I-IV oral mucositis|First 30 days post-tranplantation|||percentage of participants|||Number
811468|NCT01066780|Secondary|The AzBio Sentences Will be Administered in Recorded Format in Multi-talker Babble.||2-4 weeks||||||
811469|NCT01066780|Primary|Speech Perception of Standardized Sentences Presented From Recorded Format in Speech-spectrum Noise|This was a within subjects design where scores on the AzBio sentence test in speech spectrum noise were compared against quiet scores at the 2-Week and 4-Week Follow-up Visit. The AzBio corpus of sentences consists of 33 lists of 20 sentences each (6 to 10 words per sentence) that have been equated for intelligibility. Two AzBio sentence lists were scored at each follow-up visit (2-Week and 4-Week) with either ClearVoice MEDIUM or ClearVoice HIGH enabled and averaged together. Two AzBio sentence lists were also administered in quiet at each visit. The ClearVoice score minus the quiet score provided the difference in score for the analysis.|4 Weeks|||percentage of words scored correctly||Standard Deviation|Mean
811470|NCT01066793|Secondary|Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 24 Weeks After End of Treatment|Participants whose last test result in their respective follow-up time window showed mVR were considered to have maintained their mEOT-R. Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. The number of participants with relapse was reported in treatment naive PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.||percentage of participants|||Number
811471|NCT01066793|Secondary|Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 24 Weeks After End of Treatment|Participants whose last test result in the follow-up time window showed mVR were considered to have maintained their mEOT-R. Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. The number of participants with relapse was reported in treatment naive mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a BL result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.||percentage of participants|||Number
811472|NCT01066793|Secondary|Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 12 Weeks After End of Treatment|Participants whose last test result in their respective follow-up time window showed mVR were considered to have maintained their mEOT-R. Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. The number of participants with relapse was reported in treatment naive PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 12 weeks after EOT|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.||percentage of participants|||Number
811480|NCT01066793|Primary|Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population|The probability that a participant who developed VR by Week 4 and 12 and also achieved mSVR at 24 weeks after EOT was called the positive predictive value (PPV) of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 4 and 12 and also failed to achieve mSVR at 24 weeks after EOT was called the negative predictive value (NPV) of the VR by Wk 4 and 12 for mSVR. Predictive values of VR are reported in treatment naive HCV mono-infected mTRT participants who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a BL result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.||percentage of participants||95% Confidence Interval|Number
811473|NCT01066793|Secondary|Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 12 Weeks After End of Treatment|Participants whose last test result in their respective follow-up time window showed mVR were considered to have maintained their modified end of treatment response (mEOT-R). Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. The number of participants with relapse was reported in treatment naive mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 12 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a BL result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.||percentage of participants|||Number
811474|NCT01066793|Secondary|Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12|RVR was defined as as VR by Wk 4, mRVR was defined as mVR by Wk 4, cEVR was defined as VR by Wk 12, but no RVR, mcEVR was defined as mVR by Wk 12, but no mRVR, pEVR was defined as at least a 2-log10 drop in HCV RNA as compared to baseline (including HCV RNA values <50 IU/mL) by Wk 12, but no RVR and no cEVR, mpEVR was defined as at least a 2-log10 drop in HCV RNA as compared to baseline by Wk 12, but no mRVR and no mcEVR. The data is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b.|At Week 4 and Week 12|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.||number of participants|||Number
811475|NCT01066793|Secondary|Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12|Rapid virological response (RVR) was defined as VR by Wk 4, Modified rapid virological response (mRVR) was defined as mVR by Wk 4, complete early virological response (cEVR) was defined as VR by Wk 12, but no RVR, modified complete early virological response (mcEVR) was defined as mVR by Wk 12, but no mRVR, partial early virological response (pEVR) was defined as at least a 2-log10 drop in HCV RNA as compared to baseline (including HCV RNA values <50 IU/mL) by, Wk 12, but no RVR and no cEVR, modified partial early virological response (mpEVR) was defined as at least a 2-log10 drop in HCV RNA as compared to baseline by Wk 12, but no mRVR and no mcEVR. The data is reported in treatment naive HCV mono-infected mTRT participants who received PEG-IFN alfa-2a and PEG-IFN alfa-2b.|At Week 4 and Week 12|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a BL result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.||number of participants|||Number
811476|NCT01066793|Secondary|Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population|The probability that a participant who developed VR by Wk 2 and achieved mSVR at 24 weeks after EOT was called the PPV of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 2 and also failed to achieve mSVR at 24 weeks after EOT was called the NPV of the VR by Wk 2 for mSVR. Predictive values of VR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|24 weeks after EOT|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.||percentage of participants||95% Confidence Interval|Number
811477|NCT01066793|Secondary|Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population|The probability that a participant who developed VR by Wk 2 achieved mSVR at 24 weeks after EOT was called the PPV of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 4 and 12 and also failed to achieve mSVR at 24 weeks after EOT was called the NPV of the VR by Wk 4 and 12 for mSVR. Predictive Values of VR was reported in treatment naive HCV mono-infected mTRT population participants who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|24 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a BL result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.||percentage of participants||95% Confidence Interval|Number
811478|NCT01066793|Secondary|Percentage of Participants With at Least a 1-logarithm 10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12|Participants with 1-log drop in HCV RNA including HCV RNA values <50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 1- log drop in HCV RNA was defined as drop of HCV viral load by 90%. The 1- log drop in HCV RNA was reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b.|At Week 2, Week 4 and Week 12|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.||percentage of participants||95% Confidence Interval|Number
811479|NCT01066793|Primary|Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population|The probability that a participant who developed VR by Week 4 and 12 and also achieved mSVR at 24 weeks after EOT was called the PPV of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 4 and 12 and also failed to achieve mSVR at 24 weeks after EOT was called the NPV of the VR by Wk 4 and 12 for mSVR. Predictive values of VR are reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.||percentage of participants||95% Confidence Interval|Number
811547|NCT01067105|Primary|Percentage of Subjects Experiencing Serious Adverse Events (SAEs)||Weeks 1-26|Intent to Treat Population||percentage of participants|||Number
811481|NCT01066793|Secondary|Percentage of Participants With at Least a 1-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12|Participants with 1-log drop in HCV RNA including HCV RNA values <50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 1- log drop in HCV RNA was defined as drop of HCV viral load by 90%. The 1- log drop in HCV RNA was reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b.|At Week 2, Week 4 and Week 12|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a BL result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.||percentage of participants||95% Confidence Interval|Number
811482|NCT01066793|Secondary|Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12|Participants with 2-log drop in HCV RNA including HCV RNA values <50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 2 log drop in HCV RNA was defined as drop of HCV viral load by 99%. The 2 log drop in HCV RNA is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b.|At Week 2, Week 4 and Week 12|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.||percentage of participants||95% Confidence Interval|Number
811483|NCT01066793|Secondary|Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12|Participants with 2-logarithm (log) drop in HCV RNA including HCV RNA values <50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 2 log drop in HCV RNA was defined as drop of HCV viral load by 99%. The 2 log drop in HCV RNA is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b.|At Week 2, Week 4 and Week 12|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a BL result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.||percentage of participants||95% Confidence Interval|Number
811484|NCT01066793|Primary|Percentage of Participants With Modified Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population|Modified sustained virological response is defined as mVR of HCV RNA <50 IU/mL at 24 weeks after EOT. The mSVR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.||percentage of participants||95% Confidence Interval|Number
811485|NCT01066793|Primary|Percentage of Participants With Modified Sustained Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population|Modified sustained virological response (mSVR) was defined as modified virological response (mVR) of HCV RNA <50 IU/mL at 24 weeks after EOT. The mSVR is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a BL result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.||percentage of participants||95% Confidence Interval|Number
811486|NCT01066793|Secondary|Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time|Modified virological response (mVR) is defined as HCV RNA <50 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The mVR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. PEOT= Post End of Treatment|At Week 2, Week 4, Week 12, EOT, and 12 Weeks after EOT|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.||percentage of participants||95% Confidence Interval|Number
811487|NCT01066793|Secondary|Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time|Modified virological response (mVR) was defined as HCV RNA <50 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The mVR is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. PEOT= Post End of Treatment|At Week 2, Week 4, Week 12, EOT, and 12 Weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a BL result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.||percentage of participants||95% Confidence Interval|Number
811488|NCT01066793|Secondary|Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time|Virological response (VR) was defined as HCV RNA <15 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The VR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. PEOT= Post End of Treatment|At Week 2, Week 4, Week 12, EOT, and 12 Weeks after EOT|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.||percentage of participants||95% Confidence Interval|Number
811489|NCT01066793|Secondary|Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time|Virological response (VR) was defined as HCV RNA <15 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The VR is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. PEOT= Post End of Treatment|At Week 2, Week 4, Week 12, EOT, and 12 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a BL result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.||percentage of participants||95% Confidence Interval|Number
811490|NCT01066793|Primary|Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population|Sustained virological response was defined as VR at 24 weeks after EOT. Virological response was defined as HCV RNA of <15 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The SVR is reported in treatment naive HCV mono-infected per protocol (PP) population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.||percentage of participants||95% Confidence Interval|Number
811491|NCT01066793|Primary|Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population|Sustained virological response (SVR) was defined as virological response (VR) at 24 weeks after end of treatment (EOT). Virological response was defined as hepatitis C virus ribonucleic acid (HCV RNA) of <15 international units per milliliter (IU/mL) as assessed by COBAS AmpliPrep/COBAS TaqMan (CAP/CTM) or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (lower limit of detection [LLOD] 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The SVR is reported in treatment naive HCV mono-infected modified all-treated (mTRT) population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a baseline (BL) result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.||percentage of participants||95% Confidence Interval|Number
811492|NCT01066819|Secondary|Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per-Protocol Population at 24 Weeks After End of Treatment|Participants whose last test result in the follow-up time window showed mVR were considered to have maintained their modified end of treatment response (mEOT-R). Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. It was reported in treatment naive HCV mono-infected PP population receiving PEG-IFN alfa-2a and PEG-IFN alfa-2b. EOT= 12, 24, 48 or 72 weeks after initiation of treatment. No participants were analysed for arm 'Genotype Unknown'.|At 24 weeks after EOT|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.||Percentage of Participants|||Number
811493|NCT01066819|Secondary|Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per-Protocol Population at 12 Weeks After End of Treatment|Participants whose last test result in the follow-up time window showed mVR were considered to have maintained their modified end of treatment response (mEOT-R). Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. It was reported in treatment naive HCV mono-infected PP population receiving PEG-IFN alfa-2a and PEG-IFN alfa-2b. EOT= 12, 24, 48 or 72 weeks after initiation of treatment.|At 12 weeks after EOT|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.||Percentage of Participants|||Number
811494|NCT01066819|Secondary|Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 24 Weeks After End of Treatment|Participants whose last test result in the follow-up time window showed mVR were considered to have maintained their modified end of treatment response (mEOT-R). Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. It was reported in treatment naive HCV mono-infected mTRT population receiving PEG-IFN alfa-2a and PEG-IFN alfa-2b. EOT= 12, 24, 48 or 72 weeks after initiation of treatment. No participants were analysed for arm 'Genotype Unknown'.|24 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV ribonucleic acid (RNA) result. Participants with a baseline result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.||Percentage of Participants|||Number
811495|NCT01066819|Secondary|Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 12 Weeks After End of Treatment|Participants whose last test result in their respective follow-up time window showed mVR were considered to have maintained their modified end of treatment response (mEOT-R). Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. The number of participants with relapse was reported in treatment naive mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 12 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a baseline result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.||Percentage of Participants|||Number
811496|NCT01066819|Secondary|Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12|RVR was defined as as VR by Wk 4, mRVR was defined as mVR by Wk 4, cEVR was defined as VR by Wk 12, but no RVR, mcEVR was defined as mVR by Wk 12, but no mRVR, pEVR was defined as at least a 2-log10 drop in HCV RNA as compared to baseline (including HCV RNA values <50 IU/mL) by Wk 12, but no RVR and no cEVR, mpEVR was defined as at least a 2-log10 drop in HCV RNA as compared to baseline by Wk 12, but no mRVR and no mcEVR. The data is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b.|During first 12 weeks of treatment|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.||participants|||Number
811497|NCT01066819|Secondary|Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12|Rapid virological response (RVR) was defined as VR by Wk 4, Modified rapid virological response (mRVR) was defined as mVR by Wk 4, complete early virological response (cEVR) was defined as VR by Wk 12, but no RVR, modified complete early virological response (mcEVR) was defined as mVR by Wk 12, but no mRVR, partial early virological response (pEVR) was defined as at least a 2-log10 drop in HCV RNA as compared to baseline (including HCV RNA values <50 IU/mL) by Wk 12, but no RVR and no cEVR, modified partial early virological response (mpEVR) was defined as at least a 2-log10 drop in HCV RNA as compared to baseline by Wk 12, but no mRVR and no mcEVR. The data is reported in treatment naive HCV mono-infected mTRT participants who received PEG-IFN alfa-2a and PEG-IFN alfa-2b.|At Week 4 and Week 12|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV ribonucleic acid (RNA) result. Participants with a baseline result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.||participants|||Number
811498|NCT01066819|Secondary|Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population|The probability that a participant who developed VR by Wk 2 and achieved mSVR at 24 weeks after EOT was called the PPV of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 2 and also failed to achieve mSVR at 24 weeks after EOT was called the NPV of the VR by Wk 2 for mSVR. Predictive values of VR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.||percentage of participants||95% Confidence Interval|Number
811499|NCT01066819|Secondary|Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population|The probability that a participant who developed VR by Wk 2 achieved mSVR at 24 weeks after EOT was called the PPV of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 4 and 12 and also failed to achieve mSVR at 24 weeks after EOT was called the NPV of the VR by Wk 4 and 12 for mSVR. Predictive Values of VR was reported in treatment naive HCV mono-infected mTRT population participants who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a baseline result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.||percentage of participants||95% Confidence Interval|Number
811500|NCT01066819|Secondary|Percentage of Participants With at Least a 1-log10 Drop in Hepatitis C Virus Ribonucleic Acid in Per-Protocol Population at Week 2, Week 4 and Week 12|Participants with 1-log drop in HCV RNA including HCV RNA values <50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 1- log drop in HCV RNA was defined as drop of HCV viral load by 90%. The 1- log drop in HCV RNA was reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b.|At Week 2, Week 4 and Week 12|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.||percentage of participants||95% Confidence Interval|Number
811501|NCT01066819|Secondary|Percentage of Participants With at Least a 1-log10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12|Participants with 1-log drop in HCV RNA including HCV RNA values <50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 1- log drop in HCV RNA was defined as drop of HCV viral load by 90%. The 1- log drop in HCV RNA was reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b.|At Week 2, Week 4 and Week 12|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a baseline result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.||percentage of participants||95% Confidence Interval|Number
811548|NCT01067105|Primary|Percentage of Subjects Experiencing Adverse Events (AEs)||Weeks 1-26|Intent to Treat Population||percentage of participants|||Number
811502|NCT01066819|Secondary|Percentage of Participants With at Least a 2-log10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12|Participants with 2-log drop in HCV RNA including HCV RNA values <50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 2 log drop in HCV RNA was defined as drop of HCV viral load by 99%. The 2 log drop in HCV RNA is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b.|At Week 2, Week 4 and Week 12|Th PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.||percentage of participants||95% Confidence Interval|Number
811503|NCT01066819|Secondary|Percentage of Participants With at Least a 2-log10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12|Participants with 2-logarithm (log) drop in HCV RNA including HCV RNA values <50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 2 log drop in HCV RNA was defined as drop of HCV viral load by 99%. The 2 log drop in HCV RNA is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b.|At Week 2, Week 4 and Week 12|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a baseline result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.||percentage of participants||95% Confidence Interval|Number
811504|NCT01066819|Secondary|Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time|Modified virological response (mVR) is defined as HCV RNA <50 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The mVR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. PEOT= Post End of Treatment|At Week 2, Week 4, Week 12, EOT, and at 12 Weeks after EOT|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.||percentage of participants||95% Confidence Interval|Number
811505|NCT01066819|Secondary|Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time|Modified virological response (mVR) was defined as HCV RNA <50 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The mVR is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. PEOT= Post End of Treatment|At Week 2, Week 4, Week 12, EOT, and at 12 Weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a baseline result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.||percentage of participants||95% Confidence Interval|Number
811506|NCT01066819|Secondary|Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time|Virological response (VR) was defined as HCV RNA <15 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The VR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. PEOT= Post End of Treatment|At Week 2, Week 4, Week 12, EOT, and at 12 Weeks after EOT|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.||percentage of participants||95% Confidence Interval|Number
811507|NCT01066819|Secondary|Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time|Virological Response (VR) was defined as HCV RNA <15 IU/mL as assessed by COBAS AmpliPrep/COBAS TaqMan (HCV) (CAP/CTM) or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (lower limit of detection 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. PEOT= Post End of Treatment. EOT= 12, 24, 48 or 72 weeks after initiation of treatment.|At Week 2, Week 4, Week 12, EOT, and at 12 Weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a baseline result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.||percentage of participants||95% Confidence Interval|Number
811508|NCT01066819|Primary|Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population|The probability that a participant who developed VR by Week 4 and 12 and also achieved mSVR at 24 weeks after EOT was called the PPV of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 4 and 12 and also failed to achieve mSVR at 24 weeks after EOT was called the NPV of the VR by Wk 4 and 12 for mSVR. Predictive values of VR are reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.||percentage of participants||95% Confidence Interval|Number
811517|NCT01066871|Secondary|Number of Participants With Global Evaluation of Treatment Benefit|Participants were asked to evaluate and rate the treatment benefit as poor, fair, good, very good or excellent.|Months 3, 6 and 12|"The mITT analysis set included all participants from the ITT analysis set who had at least 1 post-treatment magnetic resonance imaging assessment. n signifies the participants who were evaluable for this outcome measure for each group, respectively."||participants|||Number
811509|NCT01066819|Primary|Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population|The probability that a participant who developed VR by Week 4 and 12 and also achieved mSVR at 24 weeks after EOT was called the positive predictive value (PPV) of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 4 and 12 and also failed to achieve mSVR at 24 weeks after EOT was called the negative predictive value (NPV) of the VR by Wk 4 and 12 for mSVR. Predictive values of VR are reported in treatment naive HCV mono-infected mTRT participants who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a baseline result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.||percentage of participants||95% Confidence Interval|Number
811510|NCT01066819|Primary|Percentage of Participants With Modified Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population|Modified sustained virological response is defined as mVR of HCV RNA <50 IU/mL at 24 weeks after EOT. The mSVR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.||percentage of participants||95% Confidence Interval|Number
811511|NCT01066819|Primary|Percentage of Participants With Modified Sustained Virological Response Over Time by Type of Peginterferon and Genotype in Modified All Treated Population|Modified sustained virological response (mSVR) was defined as modified virological response (mVR) of HCV RNA <50 IU/mL at 24 weeks after EOT. The mSVR is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a baseline result <50 international units per millilitre (IU/mL) were excluded. n = the number of participants analyzed at a given time point.||percentage of participants||95% Confidence Interval|Number
811512|NCT01066819|Primary|Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population|Sustained virological response was defined as VR at 24 weeks after EOT. Virological response was defined as HCV RNA of <15 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The SVR is reported in treatment naive HCV mono-infected per protocol (PP) population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The per-protocol (PP) population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.||percentage of participants||95% Confidence Interval|Number
811513|NCT01066819|Primary|Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population|Sustained virological response (SVR) was defined as virological response (VR) at 24 weeks after end of treatment (EOT). Virological response was defined as hepatitis C virus ribonucleic acid (HCV RNA) of <15 international units per milliliter (IU/mL) as assessed by COBAS AmpliPrep/COBAS TaqMan (CAP/CTM) or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (lower limit of detection [LLOD] 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The SVR is reported in treatment naive HCV mono-infected modified all-treated (mTRT) population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks (Wk) after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a baseline (BL) result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.||percentage of participants||95% Confidence Interval|Number
811514|NCT01066871|Secondary|Number of Participants With Binding Antibodies (BAbs) and Neutralizing Antibodies (NAbs) to Fibroblast Growth Factor 18 (FGF18)|Number of participants with BAbs and NAbs to FGF18 at Week 1 (pre-dose), Week 2 (pre-dose), Week 4, Months 3 and 12 were reported.|Week 1 (pre-dose), Week 2 (pre-dose), Week 4, Months 3 and 12|Safety analysis set included all participants who received at least 1 dose of trial treatment and who had at least 1 post injection safety assessment.||participants|||Number
811515|NCT01066871|Secondary|Number of Participants With Acute Inflammatory Reactions|Acute inflammatory reaction (AIR) is defined as an increase of pain by 30 millimeter (mm) on a 100 mm visual analog scale (VAS) associated with a subject-reported synovial fluid effusion within 3 days following intra-articular injection.|Baseline up to Month 12|"Safety analysis set included all participants who received at least 1 dose of trial treatment and who had at least 1 post injection safety assessment. N (number of participants analyzed) signifies the participants who were evaluable for this outcome measure."||participants|||Number
811516|NCT01066871|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs), Local TEAEs, Systemic TEAEs, TEAEs Leading to Discontinuation and Serious Adverse Events (SAEs)|An adverse event (AE) is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An SAE is an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs are those AEs that either started or worsened in severity on or after the date of first dose of study drug and on or before Month 12. Local TEAEs are those only related to the target knee. Systemic TEAEs are those that are related to other parts of the body.|Baseline up to Month 12|Safety analysis set included all participants who received at least 1 dose of trial treatment and who had at least 1 post injection safety assessment.||participants|||Number
828122|NCT01214824|Primary|Change in HbA1C From Baseline to 6 Months|HbA1c at baseline HbA1c at 6 months Change in HbA1c(%)(6 months – baseline)|Baseline and 6 months|Intention to treat analysis||HbA1c %||Standard Deviation|Mean
811518|NCT01066871|Secondary|Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12|The KOOS is a knee-specific self-administered questionnaire that assesses symptoms and problems associated with knee injury and osteoarthritis. It consists of 42 items grouped into 5 sub-scales: symptoms, pain, function in daily living (FDL), function in sports and recreation activities (FSRA), and quality of life (QoL). Sub-scale scores range from 0-100, with 0 representing extreme knee problems and 100 no knee problems. The IKDC consists of 19 items to summarize symptoms such as highest level of activity without significant pain, frequency and severity of pain scales, stiffness and swelling, highest levels of activity without significant swelling or giving way, knee lock or catch, highest level of activity that can be performed on a regular basis, effect of knee on ability to perform set tasks, knee function prior to injury, and current knee function. The IKDC scores range from 0-100 where high score represents high levels of function.|Baseline, Months 3, 6 and 12|"The mITT analysis set included all participants from the ITT analysis set who had at least 1 post-treatment magnetic resonance imaging assessment. n signifies the participants who were evaluable for this outcome measure for each group, respectively."||units on a scale||Standard Deviation|Mean
811519|NCT01066871|Secondary|Number of Participants With Change From Baseline in International Cartilage Repair Society (ICRS) Grade at Months 6 and 12|The ICRS grading is used to score the amount of cartilage repair and damage. The grades range from 1 to 4 where higher grades indicate more severity of injury. Number of participants with change value of -3, -2, -1, 0, 1, and 2 from baseline in ICRS grade at Months 6 and 12 were reported. Lower change value indicates less severity of injury.|Baseline, Months 6 and 12|"The mITT analysis set included all participants from the ITT analysis set who had at least 1 post-treatment magnetic resonance imaging assessment. n signifies the participants who were evaluable for this outcome measure for each group, respectively."||participants|||Number
811520|NCT01066871|Secondary|Number of Participants With Shift From Baseline in BLOKS Sub-Scales (Cartilage 1, Synovitis, Effusion) Scores at Month 12|The BLOKS scoring system assesses intra-articular regions within the knee according to the following features: BML size, cartilage 1, osteophyte size, synovitis, effusion, meniscal extrusion, and meniscal tear. Total number of participants with shift from baseline in various BLOKS sub-scales (cartilage 1 [patella medial, patella lateral, femur medial trochlea, femur lateral trochlea, medial weight bearing femur, lateral weight bearing femur, tibia medial, tibia lateral], synovitis, and effusion) scores at Month 12 were reported.|Month 12|The mITT analysis set included all participants from the ITT analysis set who had at least 1 post-treatment magnetic resonance imaging assessment.||participants|||Number
811521|NCT01066871|Secondary|Change From Baseline in Boston Leeds Osteoarthritis Knee Score (BLOKS) Sub-scale (Bone Marrow Lesion [BML] Size, Osteophyte Size, Meniscal Extrusion Score [MES], and Meniscal Tear Score [MTS]) Scores at Month 12|The BLOKS scoring system assesses intra-articular regions within the knee according to the following features: BML size, cartilage 1, osteophyte size, synovitis, effusion, meniscal extrusion, and meniscal tear. Change from baseline in summary scores for BML size, osteophyte size, MES, and MTS were reported. Summary scores for BML size range from 0 to 27, for osteophyte size range from 0 to 36, for MES range from 0 to 12, and for MTS range from 0 to 32, with lower scores corresponding to favorable outcomes.|Baseline, Month 12|"The mITT analysis set included all participants from the ITT analysis set who had at least 1 post-treatment magnetic resonance imaging assessment. n signifies the participants who were evaluable for this outcome measure for each group, respectively."||units on a scale||Standard Deviation|Mean
811522|NCT01066871|Secondary|Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales|MOCART scoring system (comprising 9 variables) was used to describe the morphology & signal intensity of the repair tissue following MRI -degree of defect repair [DDR] score 0 (subchondral bone exposed) to 20 (complete repair); integration to the border zone [IBZ] score 0 (> 50% of length of repair tissue) to 15 (complete integration to border zone);surface of repair tissue [SRT] score 0 (>50% surface repair tissue/total degradation) to 10(surface intact);structure of repair tissue [StRT] score 0(inhomogenous/cleft formation) to 5 (homogenous);signal intensity [T2] Mapping Sequence [T2MS] and Hi-Res Sagittal Pharmacodynamic Sequence [Hi-Res SPS] score 0 (marked hyper intense for T2MS and hypo intense for Hi-Res SPS) to 15 (iso intense); subchondral lamina,subchondral bone score 0 (not impact) to 5 (intact);adhesions & effusion score 0 (yes) and 5 (no). Higher values represent more favorable outcome of repair.|Months 3 (M3), 6 (M6) and 12 (M12)|"The mITT analysis set included all participants from the ITT analysis set who had at least 1 post-treatment magnetic resonance imaging assessment. n signifies the participants who were evaluable for this outcome measure for each group, respectively."||participants|||Number
811523|NCT01066871|Secondary|Change From Baseline in Cartilage Defect Thickness in the Target Knee at Months 3, 6 and 12|The change in cartilage defect thickness at Months 3, 6 and 12 based on central MRI was calculated as thickness at Months 3, 6 and 12 minus thickness at baseline, respectively.|Baseline, Months 3, 6 and 12|"The modified intent-to-treat (mITT) analysis set included all participants from the ITT analysis set who had at least 1 post-treatment magnetic resonance imaging assessment. n signifies the participants who were evaluable for this outcome measure for each group, respectively."||millimeter||Standard Deviation|Mean
811524|NCT01066871|Secondary|Change From Baseline in Cartilage Defect Volume in the Target Knee at Months 3, 6 and 12|The change in cartilage defect volume at Months 3, 6 and 12 based on central MRI was calculated as volume at Months 3, 6 and 12 minus volume at baseline, respectively.|Baseline, Months 3, 6 and 12|"The mITT analysis set included all participants from the ITT analysis set who had at least 1 post-treatment magnetic resonance imaging assessment. n signifies the participants who were evaluable for this outcome measure for each group, respectively."||microliter||Standard Deviation|Mean
811525|NCT01066871|Secondary|Percent Change From Baseline in Cartilage Defect Volume and Cartilage Defect Thickness in the Target Knee at Months 3 and 6|Percent change in cartilage defect volume and cartilage defect thickness at Months 3 and 6 based on central MRI was calculated as: ([volume or thickness at Months 3 and 6 minus volume or thickness at baseline, respectively]*100)/volume or thickness at baseline.|Baseline, Months 3 and 6|"The mITT analysis set included all participants from the ITT analysis set who had at least 1 post-treatment magnetic resonance imaging assessment. n signifies the participants who were evaluable for this outcome measure for each group, respectively."||Percent change||Standard Deviation|Mean
829193|NCT01225055|Secondary|Bone Mineral Density (BMD) by DXA at Femoral Neck|The mean change in BMD of the femoral neck after 12 month of treatment|12 Month|||g/cm squared||95% Confidence Interval|Mean
811528|NCT01066897|Primary|Change in Mesolimbic Reward System Activity From Pre to Post Treatment (8 Weeks)|Because of the limited number of depressed patients who completed the study (n=5) and noisy/unusable imaging data at various time points, this data was unable to be examined.|baseline and Week 8|Because of the limited number of depressed patients who completed the study (n=5) and noisy/unusable imaging data at various time points, this data was unable to be examined.|||||
811529|NCT01066897|Primary|% Change in Hamilton Depression Rating Scale From Baseline to week8|"Utilized the Hamilton Depression Rating Scale, 21-item version to assess depressive symptoms, with a range of 0-63. Higher scores equals more depression. For the change score, where higher equals greater improvement in depressive symptoms.
Healthy controls were not utilized in this analysis, as no week 8 ratings for health controls were obtained."|Baseline and weeks 8|For two drop outs, used LOCF||percentage reduction in depression score||Standard Deviation|Mean
811530|NCT01066897|Primary|Number of Participants Who Discontinued Study Due to Side-effects of the Medication||throughout the 8 weeks|# of participants who dropped out due to medication side-effects||Participants|||Count of Participants
811531|NCT01066923|Secondary|Hyperthermia and Hemoconcentration Identified by Retinal Imaging|This measure was not collected. Equipment was not available.|0, 30, 60, and 90 minutes post exercise||||||
811532|NCT01066923|Secondary|Activation of Coagulation|This measure was not collected. Equipment was not available.|0, 30, 60, and 90 minutes post exercise||||||
811533|NCT01066923|Primary|Vascular Function Measured by Peripheral Arterial Tonometry|Reactive Hyperemia Index|Baseline, 30, 60, and 90 minutes post exercise|||ratio (Reactive Hyperemia Index)||Standard Deviation|Mean
811534|NCT01066923|Primary|Platelet Closure Time||0, 30, 60, and 90 minutes post exercise|||seconds||Inter-Quartile Range|Median
811535|NCT01067105|Secondary|Number of Subjects Responding to the Subject Satisfaction Dose Indicator Survey|Participants responding to a survey that consisted of 7 questions assessing subject satisfaction with the dose indicator.|Weeks 6 and 12|Intent to Treat Population||participants|||Number
811536|NCT01067105|Secondary|Percentage of Devices With Major Discrepancies|A major discrepancy is defined as a discrepancy of >20 actuations between the dose indicator and subject self report of study medication administration|Weeks 0-6 and 6-12|Intent to Treat Population||percentage of devices|||Number
811537|NCT01067105|Secondary|Number of Devices With Major Discrepancies|A major discrepancy is defined as a discrepancy of >20 actuations between the dose indicator and subject self report of study medication administration|Weeks 0-6 and 6-12|Intent to Treat Population||devices|||Number
811538|NCT01067105|Secondary|Percentage of Devices With Actuation Consistency|Actuation consistency is defined as a dose indicator count within ±20% of the subject self report of study medication administration|Weeks 0-6 and 6-12|Intent to Treat Population||percentage of devices|||Number
811539|NCT01067105|Secondary|Number of Devices With Actuation Consistency|Actuation consistency is defined as a dose indicator count within ±20% of the subject self report of study medication administration|Weeks 0-6 and 6-12|Intent to Treat Population.||devices|||Number
811540|NCT01067105|Secondary|Ratio (Reported as Percentage) of Correct Advances of the Dose Indicator Out of Expected Advances|Ratio of correct advance is defined as the (number of doses actuated/number of doses reported) * 100% and therefore reported as a percentage.|Weeks 0-12|Intent to Treat Population. Subjects with missing dosing indicator data were excluded from these analyses.||percentage of correct advances||Standard Deviation|Mean
811541|NCT01067105|Secondary|Change From Baseline in Daily Subject-reported AM Instantaneous TNSS at Each Month Over the 6-month Treatment Period.|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the month treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Baseline and Months 1, 2, 3, 4, 5, 6|Intent to Treat Population. Subjects with missing date were not included in the analysis.||units on a scale||Standard Deviation|Mean
811542|NCT01067105|Secondary|Change From Baseline in Daily Subject-reported AM Reflective TNSS at Each Month Over the 6-month Treatment Period.|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the month treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Baseline and Months 1, 2, 3, 4, 5, and 6|Intent to Treat Population. Subjects with missing date were not included in the analysis.||units on a scale||Standard Deviation|Mean
811543|NCT01067105|Secondary|Change From Baseline in Daily Subject-reported AM Instantaneous TNSS Averaged Over the 6-month Treatment Period.|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six month treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Baseline and Weeks 1-26|Intent to Treat Population. Subjects with missing date were not included in the analysis.||units on a scale||Standard Deviation|Mean
811544|NCT01067105|Secondary|Change From Baseline in Daily Subject-reported AM Reflective TNSS Averaged Over the 6-month Treatment Period.|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:
0 = absent
= mild
= moderate
= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the 6-month treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Baseline and Weeks 1-26|Intent to Treat Population. Subjects with missing date were not included in the analysis.||units on a scale||Standard Deviation|Mean
811549|NCT01067326|Primary|Reactive Hyperemia Index (RHI)|"RHI was measured by the noninvasive endothelial peripheral arterial tomography (EndoPat) test. EndoPAT results are reported as the Endoscore (range 0-3); a score of 1.67 and lower indicates the need for immediate medical attention; a score between 1.68 and 2 indicates a need to reduce risk factors; a score above 2.1 indicates a healthy heart."|Baseline, 4 Months|||units on a scale||Inter-Quartile Range|Median
811550|NCT01067326|Secondary|Diastolic Blood Pressure||Baseline, 4 Months|||mm Hg||Standard Deviation|Mean
811551|NCT01067326|Secondary|Systolic Blood Pressure||Baseline, 4 Months|||mm Hg||Standard Deviation|Mean
811552|NCT01067326|Primary|Endothelial Progenitor Cells (EPC)|Peripheral blood mononuclear cells were stained for EPC markers (cell-surface antigens CD34/CD133/KDR) and counted by flow-cytometry.|Baseline, 4 Months|||counts per 100,000 gated events||Inter-Quartile Range|Median
811553|NCT01067339|Primary|Percentage Change in Coronary Blood Flow (CBF)|The change in coronary blood flow was measured in response to maximal dose of acetylcholine administered intracoronary during an invasive coronary endothelial function assessment. Percentage change in coronary blood flow provides a measure of endothelium dependent microvascular function.|baseline, six months|||% change coronary blood flow||Inter-Quartile Range|Mean
811554|NCT01067339|Primary|Percentage Change in Coronary Artery Diameter|The change of coronary artery diameter was measured in response to a maximal dose of acetylcholine administered intracoronary during an invasive coronary endothelial function assessment. Percentage change in coronary artery diameter provides a measure of endothelium dependent epicardial function.|baseline, six months|||% change coronary artery diameter||Inter-Quartile Range|Mean
811555|NCT01067352|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Study Drug Discontinuation|AEs: any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug , SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued from the study due to AE were also recorded.|Baseline through Week 96|Safety analysis population included all randomized participants with at least 1 post-baseline assessment.||participants|||Number
811556|NCT01067352|Secondary|Percentage of Untreated Participants Who Showed a Spontaneous Catch-up Growth|Spontaneous catch up growth was the growth shown by SGA participants having length more than third percentile at Week 96 without any study drug treatment.|Baseline through Week 96|Data was not analyzed due to small number of evaluable participants.|||||
811557|NCT01067352|Primary|Correlation Between Gene Expression Profiling and Catch-up Growth in Small for Gestational Age (SGA) Children|Gene expression profiling:analysis of ribonucleic acid (RNA) extracted from body tissue or fluids using Clontech Atlas Human Array to study level of activation of genes in tissue analyzed. Analysis was performed to identify possible correlation between catch-up growth (either spontaneous or drug-induced after Week 48) and therapeutic response to rhGH. Spontaneous catch up growth:shown by SGA participants having length more than third percentile at Week 96 without any treatment;drug induced growth was by SGA participants having length more than third percentile at Week 96 with drug treatment.|Baseline and Week 48|Gene expression profiling was not performed due to RNA degradation in nearly all of the blood samples and hence no comparison between gene expression and growth was made.|||||
811558|NCT01067456|Secondary|To Compare the Cost of Care Between the Comprehensive Cardiothoracic CT Arm and the Dedicated Aortic Dissection/Acute Coronary Syndrome/Pulmonary Embolism CT Protocol (Standard of Care) Arm||Index Hospitalization||||||
811559|NCT01067456|Primary|Length of Hospital Stay||up to 1 week|||Hours||Inter-Quartile Range|Median
811560|NCT01058642|Primary|Change in Weekly Average Numeric Pain Rating Scale (NPRS) Score From Baseline to End of Treatment (Week 2 of Each Treatment Period)|The NPRS is an 11-point scale (0 to 10) with 0 indicating no pain and 10 indicating the worst possible pain. The mean of the daily average scores were calculated from the NPRS pain assessments obtained up to 3 times per day over a 7-day period.|Baseline, Week 2 of Treatment Period 1 or 2|Zero participants were analyzed, and no data was collected for this measure. Due to lack of efficacy of ADL5747, the study was terminated early.|||||
811561|NCT01058655|Secondary|Overall Survival (OS) [Phase II]|OS based on the Kaplan-Meier method is defined as the time from study entry to death or date last known alive.|Long-term follow-up for survival was not specified per protocol. Participants were followed for up to 20 months on this study.|The analysis dataset is comprised of all evaluable phase II patients.||months||95% Confidence Interval|Median
811562|NCT01058655|Secondary|Disease Control Rate (DCR) [Phase II]|Disease Control Rate is defined as the percentage of patients who achieve confirmed stable disease (SD) or better on treatment based on RECIST 1.0 criteria. Per RECIST 1.0 for target lesions, complete response (CR) is disappearance of all target lesions and partial response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. Progressive disease (PD) is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started. SD is neither PR nor PD. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|Disease was assessed every 2 cycles on treatment. Median treatment duration on this study cohort was 2 months (range 1-16).|The analysis dataset is comprised of all evaluable phase II patients.||percentage of participants||95% Confidence Interval|Number
811563|NCT01058655|Primary|Progression-Free Survival (PFS) [Phase II]|PFS based on the Kaplan-Meier method is defined as the time from study entry to the earliest documentation of disease progression (PD) or death. Participants alive without evidence of PD were censored at the earliest date of last disease assessment. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.|Disease was assessed radiographically to document clinical progression every 2 cycles on treatment. Participants were followed for up to 16 months since study entry.|The analysis dataset is comprised of all evaluable phase II patients.||months||95% Confidence Interval|Median
812571|NCT01072357|Primary|Number of Participants With Graft Failure at Week 39 and 52|Time from surgery to overall graft failure (regardless of cause). Graft failure was monitored throughout the entire study, but only the time points at which graft failure occurred are reported below.|12 months|||Participants|||Count of Participants
811564|NCT01058655|Primary|Dose Limiting Toxicity (DLT) [Phase I]|A DLT was defined as a treatment-related (attribution possible, probable, definite) adverse event that meets any of the following criteria: Grade 3 (G3) or higher non-hematologic toxicity (excluding, nausea, vomiting, diarrhea, alopecia, hypertension, hypercholesterolemia, or hypertriglyceridemia); G3 diarrhea, nausea or vomiting lasting > 48 hours or leading to hospitalization, despite aggressive anti-diarrheal or anti-emetic medications; G4 diarrhea, despite aggressive anti-diarrheal medications; G4 vomiting, despite aggressive anti-emetic medications; G3 hypertension, for which blood pressure cannot be reduced to <150/100 with anti-hypertensive therapies; G4 hypertension or severe hypertension, as defined by systolic blood pressure >180 mmHg or diastolic blood pressure > 110 mmHg; G4 hypercholesterolemia or hypertriglyceridemia lasting > 7 days, despite appropriate use of anti-hyperlipidemic medications; G4 hematologic toxicity lasting for >5 days, including leukopenia, neutropen|Patients were assessed continuously for toxicity while on study. The observation period for DLT evaluation was the first 28 days (cycle 1) of treatment.|All PI patients who received at least one dose of the study drug were evaluable for DLT. The 2 DLTs experienced by participants in dose level cohort 3 were grade 3 fatigue and dehydration.||Participants with DLT|||Number
811565|NCT01058655|Primary|Tivozanib Maximum Tolerated Dose (MTD) [Phase I]|The tivozanib MTD in combination with everolimus is determined by the number of patients who experience a dose limiting toxicity (DLT). See subsequent primary outcome measure for the DLT definition. The MTD is defined as the highest dose at which fewer than one-third of patients experience a DLT. If no DLTs are observed, the MTD is not reached.|Patients were assessed continuously for toxicity while on study. The observation period for MTD evaluation was the first 28 days (cycle 1) of treatment.|All PI patients who received at least one dose of the study drug were evaluable for MTD unless patient withdrew before completing 1 cycle of therapy for reason other than dose-limiting toxicity.||mg daily for 3 weeks of a 4 week cycle|||Number
811566|NCT01058655|Primary|Everolimus Maximum Tolerated Dose (MTD) [Phase I]|The everolimus MTD in combination with tivozanib is determined by the number of patients who experience a dose limiting toxicity (DLT). See subsequent primary outcome measure for the DLT definition. The MTD is defined as the highest dose at which fewer than one-third of patients experience a DLT. If no DLTs are observed, the MTD is not reached.|Patients were assessed continuously for toxicity while on study. The observation period for MTD evaluation was the first 28 days (cycle 1) of treatment.|All PI patients who received at least one dose of the study drug were evaluable for MTD unless patient withdrew before completing 1 cycle of therapy for reason other than dose-limiting toxicity.||mg daily for 4 weeks of a 4 week cycle|||Number
811567|NCT01058668|Secondary|Change From Baseline in Clinical Global Impression-Severity (CGI-S) Total Score at Week 3|The CGI-S measures the investigator’s assessment of overall severity of the participant’s illness compared with the severity of illness in other patients the physician has observed using a 7-point scale (1=Normal, not ill at all to 7= Among the most extremely ill participants). A negative change from Baseline indicates improvement. Analysis is based on a MMRM using the observed cases data, with treatment group, pooled study center, visit, treatment group-by-visit interaction as factors, baseline value and baseline-by-visit interaction as covariates and an unstructured covariance matrix.|Baseline, Week 3|Intent-to-treat Population included all participants who received at least 1 dose of study drug and who had at least 1 post-baseline YMRS assessment.||score on a scale||Standard Error|Least Squares Mean
811568|NCT01058668|Primary|Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Week 3|The YMRS is an 11-item scale that assesses manic symptoms based on the participant’s perception of his or her condition over the previous 48 hours, as well as the physician’s clinical observations during the interview. The 11-items are elevated mood, increased motor activity-energy, sexual interest, sleep, irritability, rate and amount of speech, language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight. The severity of the abnormality for 7-items are rated on a five-point scale (0-4) and 4-items on a nine-point scale (0-8). The individual scores are summed for a total possible score of 0 (best) to 60 (worst). A negative change from Baseline indicates improvement. Analysis is a mixed model for repeated measurements (MMRM) using observed cases, with treatment group, pooled study center, visit, treatment group-by-visit interaction as factors, baseline value and baseline-by-visit interaction as covariates and an unstructured covariance matrix.|Baseline, Week 3|Intent-to-treat Population included all participants who received at least 1 dose of study drug and who had at least 1 post-baseline YMRS assessment.||score on a scale||Standard Error|Least Squares Mean
811569|NCT01058863|Secondary|Participants With Treatment-Emergent Adverse Events|Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 up to Day 37|Safety population of all randomized participants who received at least one dose of randomized study medication.||participants|||Number
811570|NCT01058863|Secondary|Baseline-adjusted Percent-Predicted Forced Expiratory Volume in 1 Second (PPFEV1) Area Under the Curve (AUC 0-6)|"Percent-predicted FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. Percent-predicted FEV1 is the expected FEV1 taking into account age, height, gender and race, as per the National Health and Nutrition Examination Survey III (NHANES III) reference values.
The first baseline spirometry was obtained between 6-11 AM. The highest FEV1 value from two acceptable values was captured for calculation of the efficacy endpoints. Assessments were obtained at approximately 0.5 hours and immediately before dosing, and 5 minutes, 0.25, 0.50, 0.75, 1, 2, 3, 4, 5 and 6 hours after completion of dosing."|Day 1 up to Day 30|Intent to treat population: randomized participants who received at least 1 dose of randomized study medication and had at least 1 post-baseline assessment||% predicted * hour||Standard Error|Mean
811717|NCT01059760|Primary|Change From Baseline in Participant Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) When Fasting and Fed|HOMA-IR is used to measure the severity of insulin resistance. Healthy Range: 1.0 (0.5-1.4) Less than 1.0 is optimal Above 1.9 indicates early insulin resistance Above 2.9 indicates significant insulin resistance|Baseline and 3 days|||units on a scale||Standard Deviation|Mean
811571|NCT01058863|Primary|Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6)|"FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. The baseline for each study day was the average of the 2 pre-dose FEV1 measurements on that study day.
The first baseline spirometry was obtained between 6-11 AM. The highest FEV1 value from two acceptable values was captured for calculation of the efficacy endpoints. Assessments were obtained at approximately 0.5 hours and immediately before dosing, and 5 minutes, 0.25, 0.50, 0.75, 1, 2, 3, 4, 5 and 6 hours after completion of dosing."|Day 1 up to Day 30|Intent to treat population: randomized participants who received at least 1 dose of randomized study medication and had at least 1 post-baseline assessment||L*hour||Standard Error|Mean
811572|NCT01058941|Primary|Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog) at 18 Months|The ADAS-cog assesses general cognitive function over multiple domains and evaluates memory, attention, reasoning, language, orientation, and praxis. A higher score indicates greater impairment on a range of scores from 0 to 70. A total score of 70 indicates maximum severity.|Baseline and 18 months|Twenty participants discontinued from the study prior to completing all study visits. One placebo and one treatment participant did not complete the final ADAS-cog assessment.||units on a scale||Standard Deviation|Mean
811573|NCT01058941|Primary|Change From Baseline in Activities of Daily Living (ADL) at 18 Months|The Alzheimer’s Disease Cooperative Study Activities of Daily Living Scale (ADCS-ADL) is used to assess activities of daily living in people with AD using a structured interview to ask the AD participant’s caregiver/study partner to assess functional ability over a wide range of performance measures. A higher ADL score indicates greater impairment in functional ability; scores range from 0 to 27.|Baseline and 18 months|Twenty participants discontinued from the study prior to completing all study visits. One treatment participant did not complete the final ADL assessment.||units on a scale||Standard Deviation|Mean
811574|NCT01058993|Primary|Blood Neutrophil Counts.|Effectiveness of drug based on increases of blood neutrophil counts to greater than 2.0 x 10^9 per liter|up to 14 days, depending on when subject reached peak response, i.e., the highest count after the stimulus (plerixafor)|The number of participants (6) was determined by the fact that we were studying a rare form of neutropenia, WHIMS syndrome, and we therefore recruited subjects who have WHIMS who live on the West coast. Analysis was per protocol.||10^9 per Liter||Standard Deviation|Mean
811575|NCT01059071|Secondary|AUC of DFMO in Pediatrics Using Pharmacokinetic (PK) Testing.||Cycle 1 Day 8 at hour 0 (pre-dose), 30 minutes, 1 hour, 3 hours, and 6 hours|Cohort at max dose of 1500mg/m2 BID||(mcg/ml) * hr||Standard Deviation|Mean
811576|NCT01059071|Secondary|Cmax of DFMO in Pediatrics Using Pharmacokinetic (PK) Testing.||Cycle 1 Day 8 at hour 0 (pre-dose), 30 minutes, 1 hour, 3 hours, and 6 hours|Cohort at max dose of 1500mg/m2 BID||mcg/ml||Standard Deviation|Mean
811577|NCT01059071|Secondary|Tmax of DFMO in Pediatrics Using Pharmacokinetic (PK) Testing.||Cycle 1 Day 8 at hour 0 (pre-dose), 30 minutes, 1 hour, 3 hours, and 6 hours|Cohort at max dose of 1500mg/m2 BID||hours||Standard Deviation|Mean
811578|NCT01059071|Secondary|Number of Patients With an Overall Response Rate (ORR) of PR or CR|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|1 year|18 subjects out of the 21 enrolled were evaluable. 3 subjects did not make it to an evaluable time point.||participants|||Number
811579|NCT01059071|Secondary|Progression Free Survival (PFS)|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|2 years|18 subjects out of the 21 enrolled were evaluable. 3 subjects did not make it to an evaluable time point.||Days||95% Confidence Interval|Median
811580|NCT01059071|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|To determine the safety, tolerability and maximum tolerated dose (MTD) of DFMO as a single agent and in combination with etoposide in pediatric and young adult patients with refractory or recurrent neuroblastoma|length of study plus 30 days|Received at least one dose of DFMO||participants|||Number
811581|NCT01059175|Secondary|Changes in Quality of Life Score - Minesota Living With Heart Failure Questionnaire|Changes between baseline and 24 months follow up Minesota Living with Heart Failure Questionnaire: 21 questions - addition of scores from 1 (better) to 5 (worse) for each questions.|24 months|Number of patients with data available for analysis of this objective||units on a scale||Standard Deviation|Mean
811582|NCT01059175|Secondary|Changes in Echocardiographic Indexes of Left Ventricle Remodeling|Changes between baseline and 24months follow up|24 months|Number of patients with data available for analysis of this objective||milliliter||Standard Deviation|Mean
811583|NCT01059175|Secondary|Overall Mortality||24 months|||participants|||Number
811584|NCT01059175|Secondary|Time to First Heart Failure Related Hospitalization||24 months|||days||Standard Error|Mean
811585|NCT01059175|Secondary|Number of Patients With at Least One Hospitalization Related to Heart Failure Between Randomization and the End of the Study||24 months|||participants|||Number
811586|NCT01059175|Secondary|Changes in 6 Minutes Hall Walk Distance Observed Between the Enrollment and the End of the Study|Changes between baseline and 24months follow up|24 months|||meters||Standard Deviation|Mean
811587|NCT01059175|Secondary|Rate of Adverse Events||24 months|||participants|||Number
811588|NCT01059175|Secondary|"Distribution of Improved, Unchanged and Worsened Patients as Defined Per M. Packer's Clinical Composite Score"|"Distribution of improved, unchanged and worsened patients as defined per M. Packer's clinical composite score at 24 months post implantation of the second left ventricle lead in comparison to the control group M. Packer's clinical composite score: patients were classified into 1 of 3 response groups after 24 months follow up : worsened, unchanged, or improved.
Worsened : if death, hospitalization because of or associated with worsening HF, demonstrated worsening in NYHA functional class at their 24-month visit, or if investigator judges global clinical state has worsened.
Improved :if they had not worsened and had demonstrated improvement in NYHA functional class, or or if investigator judges global clinical state has improved.
Unchanged : if none of the previous definition applies."|24 months|||participants|||Number
811718|NCT01059760|Primary|Change From Baseline in Participant Insulin When Fasting and Fed||Baseline and 3 days|||mU/L||Standard Deviation|Mean
811589|NCT01059175|Primary|"Distribution of Improved, Unchanged and Worsened Patients as Defined Per M. Packer's Clinical Composite Score"|"M. Packer's clinical composite score: patients were classified into 1 of 3 response groups after 12 months follow up : worsened, unchanged, or improved.
Worsened : if death, hospitalization because of or associated with worsening HF, demonstrated worsening in NYHA functional class at their 12-month visit, or if investigator judges global clinical state has worsened.
Improved :if they had not worsened and had demonstrated improvement in NYHA functional class, or or if investigator judges global clinical state has improved.
Unchanged : if none of the previous definition applies."|12 months|||participants|||Number
811590|NCT01059305|Primary|Overall Response|Response Evaluation Criteria In Solid Tumors (RECIST) criteria for CR = complete response, PR = partial response, SD = stable disease, PD = progressive disease, and NE = inevaluable. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): >30% decrease in sum of diameters of target lesions, reference baseline sum diameters. Progressive Disease (PD): >20% increase in sum of diameters of target lesions, reference smallest sum on study (this includes baseline sum if is smallest on study). In addition to relative increase of 20%, sum must absolute increase at least 5 mm. (Note: appearance of 1/> new lesions also considered progression). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum diameters while on study. Not evaluable (NE): Inevaluable when no imaging/measurement done|4 weeks|||Participants|||Count of Participants
811591|NCT01059344|Post-Hoc|To Achieve Clinical Remission in the Patient Population Confirmed by the Central Reader|Clinical Remission, defined as stool frequency score of 0, rectal bleeding score of 0 and absence of urgency in subjects with adequate disease extent at baseline confirmed by central reading.|6 weeks|modified ITT, eligibility confirmed by central reader||Participants|||Count of Participants
811592|NCT01059344|Secondary|Improvement|Improvement is defined as a reduction of at least 3 points from baseline in the modified UC-DAI score. (minumum 3, maximum 7, higher absolute UC-DAI scores indicate more severe disease)|10 weeks|ITT||Participants|||Count of Participants
811593|NCT01059344|Secondary|Improvement|Improvement is defined as a reduction of at least 3 points from baseline in the modified UC-DAI score. (minumum 3, maximum 7, higher absolute UC-DAI scores indicate more severe disease)|6 weeks|ITT||Participants|||Count of Participants
811594|NCT01059344|Secondary|Endoscopic Remission|Endoscopic remission is defined as a sigmoidoscopy score of 1 or less|10 weeks|ITT||Participants|||Count of Participants
811595|NCT01059344|Secondary|Endoscopic Remission|Endoscopic remission is defined as a sigmoidoscopy score of 1 or less|6 weeks|ITT||Participants|||Count of Participants
811596|NCT01059344|Secondary|Clinical Remission|Clinical remission defined as a score of 0 for stool frequency, 0 for rectal bleeding and no urgency|10 weeks|ITT||Participants|||Count of Participants
811597|NCT01059344|Primary|To Achieve Clinical Remission in Subjects With Active Ulcerative Colitis (UC).|Clinical remission defined as stool frequency score of 0, rectal bleeding score of 0, no urgency|6 weeks|ITT||participants|||Number
811598|NCT01059526|Secondary|Overall Patient Response Assessment|The Overall Response Assessment was to be completed every 30 minutes after treatment until patient discharge. Patients evaluated their response to treatment as “a lot better or resolved,” “a little better,” “the same,” “a little worse,” or “a lot worse.” The data presented is based on the best response achieved following a single dose of KALBITOR (Dose A) for the first HAE treatment episode. Responses of “a lot better or resolved” and “a little better” were combined to form a category of “Better.” Similarly, “a little worse” and “a lot worse” were combined to form a category of “Worse.” Patients treated in a clinic (study site) could have been discharged after an hour and hence may have only had 2 post-treatment evaluations (30 and 60 minutes); response assessments may not have been consistently provided when patients were treated at an alternate site outside of the study site.|within 4 hours post dose|Safety population; defined as all patients who received at least 1 treatment dose of KALBITOR. Analysis only includes episodes of patients who were treated at the study site.||participants|||Number
811599|NCT01059526|Primary|Occurrence of Adverse Events Related to Disordered Coagulation (Hypercoagulability and Hypocoagulability) Upon Exposure to KALBITOR|Events of ecchymosis, hemorrhage, petechiae, spontaneous hemorrhage, hematoma, gastrointestinal bleeding, hemorrhagic stroke and any other term indicative of a bleeding event or increased tendency for bleeding were reviewed to determine the occurrence of hypocoagulability. Events of clotting, thrombosis, pulmonary embolism, vaso-occlusive stroke, myocardial infarction, and any other term indicative of a clotting event or increased risk of clotting were reviewed to determine the occurrence of hypercoagulability.|12 months after first treatment|||participants||95% Confidence Interval|Number
811600|NCT01059526|Primary|Occurrence of Seroconversion to Anti-ecallantide Antibodies Upon Exposure to KALBITOR.|"Seroconversion is the development of detectable specific antibodies in the blood serum. Serum was tested for development of antibodies (irrespective of immunoglobulin class) against ecallantide at screening and at all safety evaluations. Positive results were to undergo a confirmatory test. Confirmed positive samples were further titered. Patients who developed an antibody response were evaluated for the development of neutralizing antibodies.
Patients also had their serum analyzed for IgE-specific antibodies to ecallantide at screening and during safety evaluations. Positive results underwent a confirmatory test. Confirmed positive samples were further titered."|12 months after first treatment|Based on total number of patients who were not positive for the antibody class at study entry and had at least one post-baseline antibody evaluation. N=40 evaluable patients for all immunoglobulin antibody classes; N=41 evaluable patients for IgE to ecallantide antibodies; N=41 evaluable patients for neutralizing antibodies to ecallantide.||participants||95% Confidence Interval|Number
811616|NCT01059617|Secondary|Titers for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.|Titers were expressed as geometric mean antibody titers (GMTs).|At Days 122, 129, 136, 143, 150, 157 and 164.|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).||Titers||95% Confidence Interval|Geometric Mean
811719|NCT01059760|Primary|Change From Baseline in Participant Human Growth Hormone (HGH) When Fasting and Fed||Baseline and 3 days|||ng/mL||Standard Deviation|Mean
811601|NCT01059526|Primary|Occurrence of Anaphylaxis or Other Adverse Events Suggestive of Hypersensitivity|Based on medical review of multiple preferred terms for treatment emergent adverse events (TEAEs) suggestive of Type 1 hypersensitivity; terms included adverse drug reaction, anaphylaxis, anaphylactic reaction, anaphylactoid reaction, hypersensitivity, erythema, flushing, hot flush, pharyngeal edema, laryngeal edema, pruritus, pruritus generalized, rash, rash erythematous, rhinitis allergic, rhinorrhea, throat irritation, urticaria, urticaria localized, dyspnea, and wheezing. Records of patients with any of these TEAE referred terms were reviewed further to assess potential hypersensitivity reactions, considering factors such as timing of TEAEs in relationship to dose (ie, occurred within 24 hours after start of KALBITOR treatment), accompanying symptoms, Investigator causality assessment (ie, reported as possibly, probably, or definitely related to study drug), and any other available clinical information. Anaphylaxis subset determined based on criteria established by the NIAID.|12 months after first treatment|Safety population; defined as all patients who received at least 1 treatment dose of KALBITOR||participants||95% Confidence Interval|Number
811602|NCT01059565|Secondary|Percentage of Missed School or Work Days|The percentage of days participants missed school or work from baseline to Week 24 was analyzed.|Baseline to Week 24|Participants in the Full Analysis Set with available data were analyzed.||percentage of days||Standard Deviation|Mean
811603|NCT01059565|Secondary|Percent of Days Hospitalized|The percentage of days hospitalized from baseline to Week 24 was analyzed.|Baseline to Week 24|Full Analysis Set||percentage of days||Standard Deviation|Mean
811604|NCT01059565|Secondary|Percentage of Days Participants Used Antibiotics|The percentage of days participants used antibiotics from baseline to Week 24 was analyzed. Antibiotics ongoing at baseline or started on or after first dose date were included in the analysis. A single antibiotic course could represent the use of multiple antibiotics. Days of antibiotic use included unique days.|Baseline to Week 24|Participants in the Full Analysis Set with available data were analyzed.||percentage of days||Standard Deviation|Mean
811605|NCT01059565|Secondary|Change in Burkholderia Spp. CFU in Sputum From Baseline to Week 24|The change in Burkholderia spp. CFU in sputum from baseline to Week 24 was analyzed.|Baseline to Week 24|Participants in the Full Analysis Set with available change data were analyzed.||log_10 CFU per gram of sputum||Standard Error|Least Squares Mean
811606|NCT01059565|Secondary|Change in BMI From Baseline to Week 24|The change in BMI from baseline to Week 24 was analyzed.|Baseline to Week 24|Participants in the Full Analysis Set with available change data were analyzed.||kg/m^2||Standard Error|Least Squares Mean
811607|NCT01059565|Secondary|AUCave of the Change From Baseline to Week 24 in Treatment Burden Score as Assessed by the CFQ-R|"The change (AUCave) from baseline to Week 24 in the treatment burden score as assessed by the CFQ-R was analyzed.
The range of scores (units) in the CFQ-R treatment burden domain is 0 to 100 with higher scores indicating better QOL."|Baseline to Week 24|Participants in the Full Analysis Set with available change data were analyzed.||units on a scale||Standard Error|Least Squares Mean
811608|NCT01059565|Secondary|AUCave of the Change From Baseline to Week 24 in Weight Score as Assessed by the CFQ-R|"The change (AUCave) from baseline to Week 24 in the weight score as assessed by the CFQ-R was analyzed.
The range of scores (units) in the CFQ-R weight domain is 0 to 100 with higher scores indicating better QOL."|Baseline to Week 24|Participants in the Full Analysis Set with available change data were analyzed.||units on a scale||Standard Error|Least Squares Mean
811609|NCT01059565|Secondary|AUCave of the Change From Baseline to Week 24 in Physical Functioning Score as Assessed by the CFQ-R|"The change (AUCave) from baseline to Week 24 in the physical functioning score as assessed by the CFQ-R was analyzed.
The range of scores (units) in the CFQ-R physical functioning domain is 0 to 100 with higher scores indicating better QOL."|Baseline to Week 24|Participants in the Full Analysis Set with available change data were analyzed.||units on a scale||Standard Error|Least Squares Mean
811610|NCT01059565|Secondary|AUCave of Relative Change From Baseline to Week 24 in FEF25-75|The relative change (AUCave) from baseline to Week 24 in mean (SE) FEF25-75 was analyzed. FEF25-75 is defined as the forced expiratory flow from 25% to 75% of the FVC.|Baseline to Week 24|Participants in the Full Analysis Set with available change data were analyzed.||percent change in FEF25-75 (liters/sec)||Standard Error|Least Squares Mean
811611|NCT01059565|Secondary|AUCave of Relative Change From Baseline to Week 24 in FVC|The relative change (AUCave) from baseline to Week 24 in mean (SE) FVC was analyzed. FVC is defined as the volume of air that can forcibly be blown out after taking a full breath.|Baseline to Week 24|Participants in the Full Analysis Set with available change data were analyzed.||percent change in FVC (liters)||Standard Error|Least Squares Mean
811612|NCT01059565|Secondary|AUCave of Relative Change From Baseline to Week 24 in FEV1|The relative change (AUCave) from baseline to Week 24 in mean (SE) FEV1 was analyzed. FEV1 is defined as the maximal volume of air that can be exhaled in 1 second.|Baseline to Week 24|Participants in the Full Analysis Set with available change data were analyzed.||percent change in FEV1 (liters)||Standard Error|Least Squares Mean
811613|NCT01059565|Secondary|AUCave of Change in CFQ-R RSS Scores From Baseline to Week 24|"The change (AUCave) in CFQ-R RSS scores from baseline to Week 24 was analyzed.
The range of scores (units) within the RSS domain is 0 to 100 with higher scores indicating fewer symptoms."|Baseline to Week 24|Participants in the Full Analysis Set with available change data were analyzed.||units on a scale||Standard Error|Least Squares Mean
811614|NCT01059565|Secondary|Total Number of Systemic and/or Inhaled Antibiotic Courses for Respiratory Events|The total number of systemic and/or inhaled antibiotic courses for respiratory events from baseline to Week 24 was analyzed. A single antibiotic course may represent the use of multiple antibiotics.|Baseline to Week 24|Full Analysis Set||antibiotic treatment courses|||Number
811615|NCT01059565|Primary|AUCave of Relative Change in FEV1 % Predicted From Baseline to Week 24|The relative change (AUCave) in FEV1 % predicted from baseline to Week 24 was analyzed. FEV1 % predicted is defined as FEV1 % of the patient divided by the average FEV1 % in the population for any person of similar age, sex and body composition. AUCave is the calculated area under the curve corrected for baseline and adjusted by the number of days on study through Week 24.|Baseline to Week 24|Full Analysis Set||percent change in FEV1% predicted||Standard Error|Least Squares Mean
811720|NCT01059760|Primary|Change From Baseline in Participant Glucose When Fasting and Fed||Baseline and 3 days|||mg/dL||Standard Deviation|Mean
812870|NCT01074502|Secondary|Safety of Apremilast 20 Mgs BID for 12 Weeks Will be Assessed by Evaluating Adverse Events (AEs), Vital Signs, Laboratory Evaluations and Withdrawals From the Study|Number of participants with adverse events|Baseline to 16 weeks||||||
811617|NCT01059617|Secondary|Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.|A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10.|At Days 122, 129, 136, 143, 150, 157 and 164.|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).||Subjects|||Number
811618|NCT01059617|Secondary|Titers for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.|Titers were expressed as geometric mean antibody titers (GMTs). GMTs of H1N1 HI antibody titers in terms of humoral immune response was pooled by the vaccination received at Day 0 (i.e. Flulaval or Saline placebo) at Days 7, 14, 21 and 122 upto the administration of the first dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccine.|Before vaccination and at Days 7, 14, 21 and 122|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).||Titers||95% Confidence Interval|Geometric Mean
811619|NCT01059617|Secondary|Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.|"A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10.
Seropositivity rates of H1N1 HI antibody titers in terms of humoral immune response was pooled by the vaccination received at Day 0 (i.e. Flulaval or Saline placebo) at Days 7, 14, 21 and 122 upto the administration of the first dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccine."|Before vaccination and at Days 7, 14, 21 and 122|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).||Subjects|||Number
811620|NCT01059617|Secondary|Titers for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.|Titers were expressed as geometric mean antibody titers (GMTs).|At Days 122, 129, 136, 143, 150, 157 and 164.|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).||Titers||95% Confidence Interval|Geometric Mean
811621|NCT01059617|Secondary|Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.|A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10.|At Days 122, 129, 136, 143, 150, 157 and 164.|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).||Subjects|||Number
811622|NCT01059617|Secondary|Titers for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.|Titers were expressed as geometric mean antibody titers (GMTs). GMTs of H1N1 HI antibody titers in terms of humoral immune response was pooled by the vaccination received at Day 0 (i.e. Flulaval or Saline placebo) at Days 7, 14, 21 and 122 upto the administration of the first dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccine.|Before vaccination and at Days 7, 14, 21 and 122|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).||Titers||95% Confidence Interval|Geometric Mean
811623|NCT01059617|Secondary|Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.|"A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10.
Seropositivity rates of H1N1 HI antibody titers in terms of humoral immune response was pooled by the vaccination received at Day 0 (i.e. Flulaval or Saline placebo) at Days 7, 14 and 21 upto the administration of the first dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccine."|Before vaccination and at Days 7, 14, 21 and 122|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).||Subjects|||Number
811624|NCT01059617|Secondary|Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.|Laboratory parameters assessed were alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT), alkaline phosphatase (AP), creatinine (CREA), blood urea nitrogen (BUN), and bilirubin (BIL) (total (T) and direct (D)). For each parameter and for each status at baseline it was assessed whether the post-vaccination values of the parameter were above, below or within the range (unkown values are also indicated).|At Day 304|"The Total Vaccinated cohort included all vaccinated subjects for whom data were available
N (Number of participants analyzed)= number of subjects with laboratory results for the specified visit and laboratory parameter in a given baseline category Thus, there are subjects with missing results which have not been mentioned here."||Subjects|||Number
811635|NCT01059617|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Related = symptom assed by the investigator as causally related to the study vaccination.|During the entire study period (up to Day 507).|||Subjects|||Number
812871|NCT01074502|Secondary|The Absolute Change in Lesion Counts (Total, Inflammatory, Non-inflammatory) From Baseline to Week 12||Baseline to12 weeks||||||
811625|NCT01059617|Secondary|Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.|Laboratory parameters assessed were white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), red blood cells (RBC), hemoglobin (Hgb), hematocrit (Hct) and platelets (PLA). For each parameter and for each status at baseline it was assessed whether the post-vaccination values of the parameter were above, below or within the range (unkown values are also indicated).|At Day 304|"The Total Vaccinated cohort included all vaccinated subjects for whom data were available.
N (Number of participants analyzed)= number of subjects with laboratory results for the specified visit and laboratory parameter in a given baseline category Thus, there are subjects with missing results which have not been mentioned here."||Subjects|||Number
811626|NCT01059617|Secondary|Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.|"Laboratory parameters assessed were alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT), alkaline phosphatise (AP), creatinine (CREA), blood urea nitrogen (BUN) and bilirubin (BIL) (total (T) and direct (D)).
For each parameter and for each status at baseline it was assessed whether the post-vaccination values of the parameter were above, below or within the range (unkown values are also indicated)."|On Days 0, 21, 122 and 164|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
811627|NCT01059617|Secondary|Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.|Laboratory parameters assessed were white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), red blood cells (RBC), hemoglobin (Hgb), hematocrit (Hct) and platelets (PLA). For each parameter and for each status at baseline it was assessed whether the post-vaccination values of the parameter were above, below or within the range (unkown values are also indicated).|On Days 0, 21, 122 and 164|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Participants|||Count of Participants
811628|NCT01059617|Secondary|Number of Subjects Reporting Solicited General Symptoms From Flulaval/Arepanrix Group,Flulaval/Unadjuvanted Arepanrix Group, Placebo/Arepanrix Group and Placebo/Unadjuvanted Arepanrix Group.|"Solicited general symptoms assessed were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and temperature (= axillary temperature equal to or above 38.0 degrees Celsius (°C)) and were collected after the administration of the Arepanrix or the unadjuvanted formulation of Arepanrix vaccine.
Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature above 39.0°C."|During the 7-day (Days 0-6) follow-up period after vaccination.|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
811629|NCT01059617|Secondary|Number of Subjects Reporting Solicited Local Symptoms From Flulaval/Arepanrix Group,Flulaval/Unadjuvanted Arepanrix Group,Placebo/Arepanrix Group and Placebo/Unadjuvanted Arepanrix Group|"Solicited local symptoms assessed were pain, redness and swelling and were collected after the administration of the Arepanrix or the unadjuvanted formulation of Arepanrix vaccine.
Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 100 millimeter (mm)."|During the 7-day (Days 0-6) follow-up period after vaccination.|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
811630|NCT01059617|Secondary|Number of Subjects Reporting Solicited General Symptoms From Flulaval Group and Placebo Group.|"Solicited general symptoms assessed were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and temperature (= axillary temperature equal to or above 38.0 degrees Celsius (°C)) and data collected was pooled by administration of vaccination received at Day 0 (i.e. Flulaval or Saline placebo).
Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature above 39.0°C."|During the 7-day (Days 0-6) follow-up period after vaccination.|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
811631|NCT01059617|Secondary|Number of Subjects Reporting Solicited Local Symptoms From Flulaval Group and Placebo Group.|"Solicited local symptoms assessed were pain, redness and swelling and data collected was pooled by administration of vaccination received at Day 0 (i.e. Flulaval or Saline placebo).
Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 100 millimeter (mm)."|During the 7-day (Days 0-6) follow-up period after vaccination.|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
811632|NCT01059617|Secondary|Number of Subjects Reporting Any and Related Potential Immune-mediated Disease (pIMDs).|pIMDs are a subset of adverse events (AEs) that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Related = symptom assed by the investigator as causally related to the study vaccination.|Within Days 0-233|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
811633|NCT01059617|Secondary|Number of Subjects Reporting Any and Related Medically Attended Adverse Events (MAEs).|MAEs refer to events that required medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Related = symptom assed by the investigator as causally related to the study vaccination.|Within Days 0-233|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
811634|NCT01059617|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Related = symptom assed by the investigator as causally related to the study vaccination. Missing values will be added once they become available.|Up to Day 234|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
812872|NCT01074502|Primary|Mean Percentage Change From Baseline in Individual Lesion Counts (Total, Inflammatory, Non-inflammatory) at Week 12||Baseline to 12 weeks||||||
811636|NCT01059617|Secondary|Number of Subjects Reporting Unsolicited AEs.|"Unsolicited AEs were collected after the administration of the Arepanrix or the unadjuvanted formulation of Arepanrix vaccine.
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms."|Within 84 days following first dose or 63 days following second dose of vaccine.|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
811637|NCT01059617|Secondary|Number of Subjects Reporting Unsolicited AEs.|"An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Unsolicited AEs were collected after the administration of the Flulaval vaccine or the placebo dose and the data has been pooled based on the vaccination received at Day 0."|Up to 21-day (Days 0-20) after vaccination|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
811638|NCT01059617|Secondary|Number of Subjects Reporting Any and Related Medically Attended Adverse Events (MAEs).|MAEs refer to events that required medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Related = symptom assed by the investigator as causally related to the study vaccination.|During the entire study period (up to Day 507).|||Subjects|||Number
811639|NCT01059617|Secondary|Number of Subjects Reporting Any and Related Potential Immune-mediated Disease (pIMDs).|pIMDs are a subset of adverse events (AEs) that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Related = symptom assed by the investigator as causally related to the study vaccination.|During the entire study period (up to Day 507).|||Subjects|||Number
811640|NCT01059617|Secondary|Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens|CD4 T cell-mediated immune responses against the antigens A/California/7/2009, A/Brisbane/59/2007 and A/Uruguay/716/2007 were analyzed for cells expressing at least 2 of the following immune markers: CD40 Ligand, Interleukin2, Tumor Necrosis Factor alpha or Interferongamma. The frequency was presented as number of cytokineproducing CD4+ cells per million CD4+ cells. All doubles= T cell expressing at least 2 cytokines.|After the administration of Arepanrix vaccine (Day 125 to 304)|The According-To-Protocol cohort for immunogenicity at Day 304 included all evaluable subjects who had not received a vaccine not specified or forbidden in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen for the blood sample taken at Day 304.||cells/million T cells||Inter-Quartile Range|Median
811641|NCT01059617|Secondary|Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens|"CD4 T cell-mediated immune responses against the antigens A/California/7/2009, A/Brisbane/59/2007 and A/Uruguay/716/2007 were analyzed for cells expressing at least 2 of the following immune markers: CD40 Ligand, Interleukin-2, Tumor Necrosis Factor alpha or Interferon-gamma.
The frequency was presented as number of cytokine-producing CD4+ cells per million CD4+ cells. All doubles= T cell expressing at least 2 cytokines.
Subjects with missing results were not included."|Before administration of Arepanrix vaccine (Day 0 to Day 122)|The ATP cohort for immunogenicity at Day 164 included subjects who received protocol specified vaccine(s) during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after second H1N1 vaccine dose (Day 164). Subjects with missing results were not included.||cells/million T cells||Inter-Quartile Range|Median
811642|NCT01059617|Secondary|Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Titers Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.|VRR for microneutralization titers was defined as the incidence rate of vaccinees with at least a 4-fold increase in post vaccination reciprocal titer relative to Day 0. The cut-off value for microneutralization titers is 1:28.|For the entire study period up to Day 507|The According-To-Protocol cohort for immunogenicity at Day 304 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at Day 304.||Subjects|||Number
811643|NCT01059617|Secondary|Titers for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.|Titers were expressed as geometric mean antibody titers (GMTs).|At Day 0 and Day 304|The According-To-Protocol cohort for immunogenicity at Day 304 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen for blood sample taken at Day 304.||Titers||95% Confidence Interval|Geometric Mean
811644|NCT01059617|Secondary|Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.|A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10.|At Days 0 and 304|The According-To-Protocol cohort for immunogenicity at Day 304 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen for blood sample taken at Day 304.||Subjects|||Number
811645|NCT01059617|Secondary|Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Titers Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.|VRR for microneutralization titers was defined as the incidence rate of vaccinees with at least a 4-fold increase in post vaccination reciprocal titer relative to Day 0. The cut-off value for microneutralization titers is 1:28.|Entire study period up to Day 507|The According-To-Protocol cohort for immunogenicity at Day 304 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at Day 304.||Subjects|||Number
831856|NCT01243320|Primary|Change in Urea Nitrogen Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days|||mg/dL||95% Confidence Interval|Mean
811646|NCT01059617|Secondary|Titers for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.|Titers were expressed as geometric mean antibody titers (GMTs).|At Days 122 and 304|The According-To-Protocol cohort for immunogenicity at Day 304 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen for blood sample taken at Day 304.||Titers||95% Confidence Interval|Geometric Mean
811647|NCT01059617|Secondary|Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.|A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10.|At Day 122 and Day 304|The According-To-Protocol cohort for immunogenicity at Day 304 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen for blood sample taken at Day 304.||Subjects|||Number
811648|NCT01059617|Primary|Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Titers Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.|VRR for microneutralization titers was defined as the incidence rate of vaccinees with at least a 4-fold increase in post vaccination reciprocal titer relative to Day 0. The cut-off value for microneutralization titers is 1:28.|21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).||Subjects|||Number
811649|NCT01059617|Primary|Titers for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.|Titers were expressed as geometric mean antibody titers (GMTs).|21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).||Titers||95% Confidence Interval|Geometric Mean
811650|NCT01059617|Primary|Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.|A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10.|21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).||Subjects|||Number
811651|NCT01059617|Primary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.|Geometric mean fold-rise (GMFR), or seronversion factor (SCF), was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.|21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 122 to Day 164).|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).||Fold increase||95% Confidence Interval|Geometric Mean
811652|NCT01059617|Primary|Number of Seroprotected Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.|Seroprotection rate (SPR) was defined as the number of subjects with H1N1 reciprocal HI titers ≥ 1:40 against the tested vaccine virus.|21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).||Subjects|||Number
811653|NCT01059617|Primary|Number of Seroconverted Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.|Seroconversion rate (SCR) was defined as the number of subjects who have either a pre-vaccination reciprocal HI titer < 1:10 and a post-vaccination reciprocal titer ≥ 1:40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.|21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).||Subjects|||Number
811654|NCT01059617|Primary|Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Titers Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.|VRR for microneutralization titers was defined as the incidence rate of vaccinees with at least a 4-fold increase in post vaccination reciprocal titer relative to Day 0. The cut-off value for microneutralization titers is 1:28.|21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).||Subjects|||Number
811674|NCT01059630|Secondary|Overall Survival (OS)|OS was defined as the time between the date of randomization and the date of death from any cause. OS was estimated using Kaplan-Meier method and 95% CI for median was computed using the method of Brookmeyer and Crowley.|Baseline until death (up to 4.5 years overall)|ITT population.||months||95% Confidence Interval|Median
811675|NCT01059630|Secondary|Percentage of Participants Who Died||Baseline until death (up to 4.5 years overall)|ITT population.||percentage of participants|||Number
811655|NCT01059617|Primary|Titers for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.|Titers were expressed as geometric mean antibody titers (GMTs).|21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).||Titers||95% Confidence Interval|Geometric Mean
811656|NCT01059617|Primary|Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.|A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10.|21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).||Subjects|||Number
811657|NCT01059617|Primary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.|Geometric mean fold-rise (GMFR), or seronversion factor (SCF), was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.|21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 122 to Day 164).|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).||Fold||95% Confidence Interval|Geometric Mean
811658|NCT01059617|Primary|Number of Seroprotected Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.|Seroprotection rate (SPR) was defined as the number of subjects with H1N1 reciprocal HI titers ≥ 40 against the tested vaccine virus.|21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).||Subjects|||Number
811659|NCT01059617|Primary|Number of Seroconverted Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.|Seroconversion rate (SCR) was defined as the number of subjects who have either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer ≥ 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.|21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).||Subjects|||Number
811660|NCT01059630|Secondary|Percentage of Participants With Definitive Improvement (DI) From Baseline in FACT-Lym Instrument Scores|FACT-Lym: 42-items in 5 subscales. Responses to each item range from 0 (Not at all) to 4 (Very much). FACT-Lym Lymphoma subscale includes 15 items (total score range = 0-60). FACT-Lym TOI is sum of 3 subscales (physical well-being, functional well-being, lymphoma subscale) and includes 29 items (total score range = 0−116). FACT-Lym total score is sum of 42 items (total score ranges from 0−168). For all above, higher scores indicate a better PRO/QoL. DI from baseline: at least 3 point increase from baseline in FACT-Lym Lymphoma subscale; at least 6 point increase from baseline in FACT Lym TOI; at least 7 point increase from baseline in FACT Lym total scores. In timeframe, follow-up months represents months after EOI (e.g. Follow-up Month 2 is 2 months after EOI; EOI = up to Month 6).|Baseline, Cycle 5 Day 1 (C5D1) (Cycle length = 28 days), Follow-up Months 6 (FUM6), and 12 (FUM12)|ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified those participants who were evaluable for a specified category.||Percentage of participants|||Number
811661|NCT01059630|Secondary|Time to Deterioration of FACT-Lym TOI|The median time, in month, from date of randomization until a clinically meaningful decline from baseline in TOI or death, whichever occurred first. TOI: sum of physical well-being score,functional well-being score, and Lymphoma sub-scale of FACT-Lym; total 29 items, responses to each item range from 0, “Not at all” to 4, “Very much”. Total score ranges from 0-116. Higher scores indicate a better PRO/QoL. A clinically meaningful decline in TOI score was defined as at least a 6 point decline from baseline. Time to deterioration was estimated using Kaplan-Meier method and 95% CI for median was computed using the method of Brookmeyer and Crowley. In timeframe, follow-up months represents months after end of induction (EOI) (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up).|Baseline up to approximately 4 years (Baseline, Day 1 of Cycles 1, 3, 4, 5, EOI treatment [up to Month 6]; Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up [up to 2 years after EOI]; Extension follow-up Months 6 and 18)|ITT population.||Months||95% Confidence Interval|Median
811676|NCT01059630|Secondary|Event-free Survival (EFS) as Assessed by IRC|EFS was defined as the time between the date of randomization and the date of PD/relapse based on IRC assessments (as per modified response criteria for iNHL [Modified Cheson et al, 2007]), death from any cause on study, or start of a new anti-lymphoma therapy. PD: appearance of any new lesion >1.5 cm in any axis during or at end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in SPD of any previously involved nodes, or in a single involved node, or size of other lesions. EFS was estimated using Kaplan-Meier method.|Baseline until PD or death, whichever occurred first (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28−42 days after Cy 6 Day 1, then every 3 months up to 2 years and every 6 months for next 2 years [up to 4.5 years overall])|ITT population.||months||95% Confidence Interval|Median
811662|NCT01059630|Secondary|CFB in FACT-Lym Total Score|FACT-Lym total score is the sum of physical well-being score (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and Lymphoma sub-scale (15 items); responses to each item range from 0, “Not at all” to 4, “Very much”. Total score ranges from 0−168. Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up).|Baseline, Day 1 of Cycles 1, 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6 and 18|ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified those participants who were evaluable for a specified time point.||Units on a scale||Standard Deviation|Mean
811663|NCT01059630|Secondary|CFB in FACT-Lym Trial Outcome Index (TOI)|TOI is the sum of 3 sub-scales (physical well-being, functional well-being, and Lymphoma sub-scale) of FACT-Lym which includes total 29 items; responses to each item range from 0, “Not at all” to 4, “Very much”. Total score ranges from 0−116. Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up).|Baseline, Day 1 of Cycles 1, 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6 and 18|ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified those participants who were evaluable for a specified time point.||Units on a scale||Standard Deviation|Mean
811664|NCT01059630|Secondary|CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score|The FACT-G is the sum of 4 sub-scales (physical, social, emotional and functional well-being) of FACT-Lym which includes total 27 items; responses to each item range from 0, “Not at all” to 4, “Very much”. Total score ranges from 0-108. Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up).|Baseline, Day 1 of Cycles 1, 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6 and 18|ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified those participants who were evaluable for a specified time point.||Units on a scale||Standard Deviation|Mean
811665|NCT01059630|Secondary|CFB in EQ-5D VAS Score During Maintenance Phase|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. Data for this outcome was planned to be reported only for ‘Obinutuzumab + Bendamustine’ arm. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction). Follow-up months were during maintenance phase.|Baseline, Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction) (end of induction = up to Month 6)|ITT population (Obinutuzumab + Bendamustine arm only). Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified those participants who were evaluable for a specified time point.||units on a scale||Standard Deviation|Mean
811666|NCT01059630|Secondary|CFB in EQ-5D Visual Analogue Scale (VAS) Score During Induction Phase|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeter (mm) (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction). For ‘Obinutuzumab + Bendamustine’ arm, participants who had their follow-up Month 2 and 4 visits before start of maintenance treatment were reported in induction phase results under “CFB at Follow-up Month 2” and “CFB at Follow-up Month 4” categories.|Baseline, Day 1 of Cycles 1, 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2 and 4|ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified those participants who were evaluable for a specified time point.||units on a scale||Standard Deviation|Mean
811667|NCT01059630|Secondary|CFB in EuroQol 5D (EQ-5D) - Health State Profile Utility Score During Maintenance Phase|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. Data for this outcome was planned to be reported only for ‘Obinutuzumab + Bendamustine’ arm. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction). Follow-up months were during maintenance phase."|Baseline, Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final follow-up (up to 2 years after end of induction) (End of induction = up to Month 6)|ITT population (Obinutuzumab + Bendamustine arm only). Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified those participants who were evaluable for a specified time point.||units on a scale||Standard Deviation|Mean
811695|NCT01059760|Primary|Change From Baseline in Participant Low-Density Lipoprotein Cholesterol (LDL-C) When Fasting and Fed||Baseline and 3 days|||mg/dL||Standard Deviation|Mean
811696|NCT01059760|Primary|Change From Baseline in Participant Total Cholesterol (TC) When Fasting and Fed||Baseline and 3 days|||mg/dL||Standard Deviation|Mean
811697|NCT01059760|Primary|Change From Baseline in Participant Creatinine When Fasting and Fed||Baseline and 3 days|||mg/dL||Standard Deviation|Mean
811668|NCT01059630|Secondary|CFB in Euro Quality of Life 5 Dimension (EuroQoL-5D/EQ-5D) - Health State Profile Utility Score During Induction Phase|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction). For ‘Obinutuzumab + Bendamustine’ arm, participants who had their follow-up Month 2 and 4 visits before start of maintenance treatment were reported in induction phase results under “CFB at Follow-up Month 2” and “CFB at Follow-up Month 4” categories."|Baseline, Day 1 of Cycles 1, 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, and 4|ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified those participants who were evaluable for a specified time point.||units on a scale||Standard Deviation|Mean
811669|NCT01059630|Secondary|CFB in FACT-Lym-Lymphoma Sub-scale Score|"The FACT-Lym measures 5 sub-scales which includes 42 items; responses to each item range from 0, Not at all to 4, Very much. Total score ranges from 0-168. Lymphoma scale includes 15 items measured on 0-4 point scale. The total score for lymphoma sub-scale is sum of each 15 items (range: 0-60). Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up)."|Baseline, Day 1 of Cycles 1, 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6 and 18|ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified those participants who were evaluable for a specified time point.||units on a scale||Standard Deviation|Mean
811670|NCT01059630|Secondary|CFB in FACT-Lym-Functional Well-Being Sub-scale Score|"The FACT-Lym measures 5 sub-scales which includes 42 items; responses to each item range from 0, Not at all to 4, Very much. Total score ranges from 0-168. Functional Well-being sub-scale includes 7 items measured on 0-4 point scale. The total score for functional well-being sub-scale is sum of each 7 items (range: 0-28). Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up)."|Baseline, Day 1 of Cycles 1, 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6 and 18|ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified those participants who were evaluable for a specified time point.||units on a scale||Standard Deviation|Mean
811671|NCT01059630|Secondary|CFB in FACT-Lym-Emotional Well-Being Sub-scale Score|"The FACT-Lym measures 5 sub-scales which includes 42 items; responses to each item range from 0, Not at all to 4, Very much. Total score ranges from 0-168. Emotional Well-being sub-scale includes 6 items measured on 0-4 point scale. The total score for emotional well-being sub-scale is sum of each 6 items (range: 0-24). Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up)."|Baseline, Day 1 of Cycles 1, 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6 and 18|ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified those participants who were evaluable for a specified time point.||units on a scale||Standard Deviation|Mean
811672|NCT01059630|Secondary|CFB in FACT-Lym-Social/Family Well-being Sub-scale Score|"The FACT-Lym measures 5 sub-scales which includes 42 items; responses to each item range from 0, Not at all to 4, Very much. Total score ranges from 0-168. Social/family Well-being sub-scale includes 7 items measured on 0-4 point scale. The total score for social/family well-being sub-scale is sum of each 7 items (range: 0-28). Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up)."|Baseline, Day 1 of Cycles 1, 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6 and 18|ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified those participants who were evaluable for a specified time point.||units on a scale||Standard Deviation|Mean
811673|NCT01059630|Secondary|Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score|"The FACT-Lym measures 5 sub-scales which includes 42 items; responses to each item range from 0, Not at all to 4, Very much. Total score ranges from 0-168. Physical Well-being sub-scale includes 7 items measured on 0-4 point scale. The total score for physical well-being sub-scale is sum of each 7 items (range: 0-28). Higher scores indicate a better participant-reported outcome (PRO)/quality of life (QoL). In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up)."|Baseline, Day 1 of Cycles 1, 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6 and 18|ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified those participants who were evaluable for a specified time point.||units on a scale||Standard Deviation|Mean
811677|NCT01059630|Secondary|Disease-Free Survival (DFS) in Participants With CR as Assessed by IRC|DFS was defined as the time from the first occurrence of a documented CR until progression on the basis of the IRC assessments (as per modified response criteria for iNHL [Modified Cheson et al, 2007]) or death from any cause on study. CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PD: appearance of any new lesion >1.5 cm in any axis during or at end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in SPD of any previously involved nodes, or in a single involved node, or size of other lesions. DFS was estimated using Kaplan-Meier method.|Baseline until PD or death, whichever occurred first (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28−42 days after Cy 6 Day 1, then every 3 months up to 2 years and every 6 months for next 2 years [up to 4.5 years overall])|ITT population. Here, number of participants analyzed signified those participants who had an objective response of CR.||months||95% Confidence Interval|Median
811678|NCT01059630|Secondary|Duration of Response (DoR) as Assessed by IRC|DoR: time from first objective response of CR/PR to first occurrence of PD/relapse/death from any cause. CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy; liver, spleen returned to normal size (if enlarged at baseline); if bone marrow was involved by lymphoma prior to treatment, infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to baseline scan and no new sites; no increase in size of other nodes, liver, or spleen; with exception of splenic, hepatic nodules; involvement of other organs is usually assessable; no presence of measurable disease. PD: appearance of any new lesion >1.5 cm in any axis during or at end of therapy, even if other lesions are decreasing in size; at least 50% increase from nadir in SPD of any previously involved nodes, or in single involved node, or size of other lesions. DoR was estimated using Kaplan-Meier method.|Baseline until PD or death, whichever occurred first (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28−42 days after Cy 6 Day 1, then every 3 months up to 2 years and every 6 months for next 2 years [up to 4.5 years overall])|ITT population. Here, number of participants analyzed signified those participants who had objective response at any time during the study.||months||95% Confidence Interval|Median
811679|NCT01059630|Secondary|Percentage of Participants With BOR at the End of Induction Treatment as Assessed by IRC and Investigator|BOR: best response for a participant, observed during assessment period according to modified response criteria for iNHL (Modified Cheson et al, 2007). CR: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in size of other nodes, liver, or spleen; with exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present, SD: Failing to attain criteria needed for a CR or PR, but not fulfilling those for PD, PD: appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or the size of other lesions (e.g., splenic or hepatic nodules).|Baseline until end of induction treatment (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28−42 days after Cy 6 Day 1)|ITT population. Here, number of participants analyzed signified those participants who had reached the end of induction treatment response assessment.||percentage of participants||95% Confidence Interval|Number
811680|NCT01059630|Secondary|Percentage of Participants With Objective Response at the End of Induction Treatment as Assessed by IRC and Investigator|Objective response was defined as having CR or PR as assessed according to the modified response criteria for iNHL (Modified Cheson et al, 2007). CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present.|Baseline until end of induction treatment (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28−42 days after Cy 6 Day 1)|ITT population. Here, number of participants analyzed signified those participants who had reached the end of induction treatment response assessment.||percentage of participants||95% Confidence Interval|Number
811681|NCT01059630|Secondary|Percentage of Participants With Best Overall Response (BOR) as Assessed by IRC and Investigator|BOR: best response for a participant, observed during assessment period according to modified response criteria for iNHL (Modified Cheson et al, 2007). CR: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, PR: at least 50% regression of measurable disease compared to tumors measured by baseline scan and no new sites; no increase in size of other nodes, liver, or spleen; with exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present, SD: Failing to attain the criteria needed for a CR or PR, but not fulfilling those for PD, PD: appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in single involved node, or the size of other lesions (e.g., splenic or hepatic nodules).|Baseline until PD or death, whichever occurred first (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28−42 days after Cy 6 Day 1, then every 3 months up to 12 months overall)|ITT population. Here, number of participants analyzed signified those participants who had at least one post-baseline assessment.||percentage of participants||95% Confidence Interval|Number
811698|NCT01059760|Primary|Change From Baseline in Participant Potassium When Fasting and Fed||Baseline and 3 days|||mmol/L||Standard Deviation|Mean
811699|NCT01059760|Primary|Change From Baseline in Participant Calcium When Fasting and Fed||Baseline and 3 days|||mg/dL||Standard Deviation|Mean
811700|NCT01059760|Primary|Change From Baseline in Participant Blood Urea Nitrogen (BUN) When Fasting and Fed||Baseline and 3 days|||mg/dL||Standard Deviation|Mean
811701|NCT01059760|Primary|Change From Baseline in Participant Chloride When Fasting and Fed||Baseline and 3 days|||mmol/L||Standard Deviation|Mean
811682|NCT01059630|Secondary|Percentage of Participants With Objective Response as Assessed by IRC and Investigator|Objective response was defined as having CR or PR as assessed according to the modified response criteria for iNHL (Modified Cheson et al, 2007). CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present.|Baseline until PD or death, whichever occurred first (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28−42 days after Cy 6 Day 1, then every 3 months up to 12 months overall)|ITT population. Here, number of participants analyzed signified those participants who had at least one post-baseline assessment.||percentage of participants||95% Confidence Interval|Number
811683|NCT01059630|Secondary|PFS as Assessed by Investigator|PFS was defined as the time from randomization to the first occurrence of PD as assessed by an investigator according to the modified response criteria for iNHL (Modified Cheson et al, 2007), or death from any cause on study. PD was defined as appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or the size of other lesions (e.g., splenic or hepatic nodules). To be considered PD, a lymph node with a diameter of the short axis of <1.0 cm must increase by ≥ 50% and to a size of 1.5 multiplied by 1.5 cm or more than 1.5 cm in the long axis; at least a 50% increase in the longest diameter of any single previously identified node >1 cm in its short axis. PFS was estimated using Kaplan-Meier method and 95% CI for median was computed using the method of Brookmeyer and Crowley.|Baseline until PD or death, whichever occurred first (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28−42 days after Cy 6 Day 1, then every 3 months up to 2 years and every 6 months for next 2 years [up to 4.5 years overall])|ITT population.||months||95% Confidence Interval|Median
811684|NCT01059630|Secondary|Number of Participants With PD or Death as Assessed by Investigator|PD was assessed by an investigator according to the modified response criteria for iNHL (Modified Cheson et al, 2007). PD was defined as appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or the size of other lesions (e.g., splenic or hepatic nodules). To be considered PD, a lymph node with a diameter of the short axis of <1.0 cm must increase by ≥ 50% and to a size of 1.5 multiplied by 1.5 cm or more than 1.5 cm in the long axis; at least a 50% increase in the longest diameter of any single previously identified node >1 cm in its short axis.|Baseline until PD or death, whichever occurred first (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28−42 days after Cy 6 Day 1, then every 3 months up to 2 years and every 6 months for next 2 years [up to 4.5 years overall])|ITT population.||participants|||Number
811685|NCT01059630|Primary|Progression-Free Survival (PFS) as Assessed by IRC|PFS was defined as the time from randomization to the first occurrence of PD or death as assessed by an IRC according to the modified response criteria for iNHL (Modified Cheson et al, 2007). PD was defined as appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or the size of other lesions (e.g., splenic or hepatic nodules). To be PD, a lymph node with a diameter of the short axis of <1.0 cm must increase by ≥ 50% and to a size of 1.5 multiplied by 1.5 cm or more than 1.5 cm in the long axis; at least a 50% increase in the longest diameter of any single previously identified node >1 cm in its short axis. PFS was estimated using Kaplan-Meier method and 95% confidence interval (CI) for median was computed using the method of Brookmeyer and Crowley.|Baseline until PD or death, whichever occurred first (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28−42 days after Cy 6 Day 1, then every 3 months up to 2 years and every 6 months for next 2 years [up to 4.5 years overall])|ITT population.||months||95% Confidence Interval|Median
811686|NCT01059630|Primary|Number of Participants With Progressive Disease (PD) as Assessed by Independent Review Committee (IRC) or Death|PD was assessed by an IRC according to the modified response criteria for indolent Non-Hodgkin's Lymphoma (iNHL) (Modified Cheson et al, 2007). PD was defined as appearance of any new lesion more than 1.5 centimeters (cm) in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50 percent (%) increase from nadir in the sum of product diameter (SPD) of any previously involved nodes, or in a single involved node, or the size of other lesions (example: splenic or hepatic nodules). To be considered PD, a lymph node with a diameter of the short axis of less than (<) 1.0 cm must increase by greater than or equal to (≥) 50% and to a size of 1.5 multiplied by 1.5 cm or more than 1.5 cm in the long axis; at least a 50% increase in the longest diameter of any single previously identified node greater than (>) 1 cm in its short axis.|Baseline until PD or death, whichever occurred first (assessed at baseline, 14 days prior to Cycle [Cy] 4 Day 1 [1 Cy=28days], 28−42 days after Cy 6 Day 1, then every 3 months up to 2 years and every 6 months for next 2 years [up to 4.5 years overall])|ITT population.||participants|||Number
811687|NCT01059760|Primary|Change From Baseline in Participant High Sensitivity C-Reactive Protein (hsCRP) When Fasting and Fed||Baseline and 3 days|||mg/L||Standard Error|Median
811688|NCT01059760|Primary|Change From Baseline in Participant Diastolic Blood Pressure (DBP), Supine When Fasting and Fed||Baseline and 3 days|||mmHg||Standard Deviation|Mean
811689|NCT01059760|Primary|Change From Baseline in Participant Systolic Blood Pressure (SBP), Supine When Fasting and Fed||Baseline and 3 days|||mmHg||Standard Deviation|Mean
811690|NCT01059760|Primary|Change From Baseline in Participant Waist Circumference When Fasting and Fed||Baseline and 3 days|||cm||Standard Deviation|Mean
811691|NCT01059760|Primary|Change From Baseline in Participant Weight When Fasting and Fed||Baseline and 3 days|||kg||Standard Deviation|Mean
811692|NCT01059760|Primary|Change From Baseline in Participant TC/HDL Ratio When Fasting and Fed||Baseline and 3 days|||ratio||Standard Deviation|Mean
811693|NCT01059760|Primary|Change From Baseline in Participant Triglycerides When Fasting and Fed||Baseline and 3 days|||mg/dL||Standard Deviation|Mean
811694|NCT01059760|Primary|Change From Baseline in Participant High-Density Lipoprotein Cholesterol (HDL-C) When Fasting and Fed||Baseline and 3 days|||mg/dL||Standard Deviation|Mean
811721|NCT01059773|Secondary|Proportion of Patients Achieving PASI 90 Response|This is based on the number of participants achieving at least 90% improvement from baseline in Psoriasis Area and Severity Index (PASI) (0 [best] - 72 [worst]). The PASI is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score.|at Weeks 2, 4, 12, 16, 28, 40 and 52|The modified intent-to-treat (mITT) analysis set includes all subjects who were randomized and received at least one dose of ustekinumab, regardless of their compliance with the protocol. Subjects who dropped out after randomization and before the first administration of ustekinumab were excluded from the mITT analysis.||Percentage of participants||95% Confidence Interval|Number
811722|NCT01059773|Secondary|Proportion of Patients Achieving PASI 75 Response|This is based on the number of participants achieving at least 75% improvement from baseline in Psoriasis Area and Severity Index (PASI) (0 [best] - 72 [worst]). The PASI is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score.|at Weeks 2, 4, 12, 16, 28, 40 and 52|The modified intent-to-treat (mITT) analysis set includes all subjects who were randomized and received at least one dose of ustekinumab, regardless of their compliance with the protocol. Subjects who dropped out after randomization and before the first administration of ustekinumab were excluded from the mITT analysis.||Percentage of participants||95% Confidence Interval|Number
811723|NCT01059773|Secondary|Proportion of Patients Achieving PASI 50 Response|This is based on the number of participants achieving at least 50% improvement from baseline in Psoriasis Area and Severity Index (PASI) (0 [best] - 72 [worst]). The PASI is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score.|at Weeks 2, 4, 12, 16, 28, 40 and 52|The modified intent-to-treat (mITT) analysis set includes all subjects who were randomized and received at least one dose of ustekinumab, regardless of their compliance with the protocol. Subjects who dropped out after randomization and before the first administration of ustekinumab were excluded from the mITT analysis.||Percentage of participants||95% Confidence Interval|Number
811724|NCT01059773|Secondary|Change in Mean Psoriasis Area-and-severity Index (PASI) Score Compared to Baseline|Change from baseline in Psoriasis Area and Severity Index (PASI) (0 [best] - 72 [worst]). The PASI is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score.|at Weeks 0, 2, 4, 12, 16, 28, 40 and 52|The modified intent-to-treat (mITT) analysis includes all subjects who were randomized and received at least one dose of ustekinumab, regardless of their compliance with the protocol. Subjects who dropped out after randomization and before the first administration of ustekinumab were excluded from the mITT analysis||Units on a scale||Standard Deviation|Mean
811725|NCT01059773|Secondary|Rate of Malignancies and Other Events of Clinical Interest (Tuberculosis, Serious Cardiovascular Events, Anaphylactic/Serum Sickness Reaction)|The number of patients with a malignancy and other event of clinical interest (tuberculosis, serious cardiovascular events, anaphylactic/serum sickness reaction) were summarized through Week 12 and through Week 52, by treatment arm and body weight category (≤100 kg and >100 kg)|at week 12, 16, 28 40 and 52|All randomized patients who took at least one dose of study medication and set who had any post-baseline safety information||Number of patients|||Number
811726|NCT01059773|Secondary|Rate of Infections, Severe Infections and Infections Requiring Oral or Parenteral Antimicrobial Treatment During the Study Period|The number of patients with any of the following TEAEs were summarized through Week 12 and through Week 52, by treatment arm and body weight category (≤100 kg and >100 kg): infections, serious infections, and infections requiring oral or parenteral antimicrobial treatment (infections being considered any event that by the investigator was indicated as infection on the CRF).|at week 12, 16, 28 40 and 52|All randomized patients who took at least one dose of study medication and set who had any post-baseline safety information||Number of patients|||Number
811727|NCT01059773|Primary|Number of Patients Experiencing One or More Adverse Events Occurring From Week 0 Through Week 12||from week 0 to week 12|All randomized patients who took at least one dose of study medication and set who had any post-baseline safety information.||participants|||Number
811728|NCT01059773|Secondary|Rate of Severe AEs, Reasonably Related AEs, and AEs Leading to Discontination During the Study Period|The number of patients with any of the following TEAEs were summarized through Week 12 and through Week 52, by treatment arm and body weight category (≤100 kg and >100 kg): AE with severe intensity; AE or SAE reasonably related to ustekinumab (i.e., AEs classified by the investigator as ‘possibly’, ‘probably’, or ‘very likely’ related to study agent); AE or SAE leading to permanent discontinuation of ustekinumab.|at week 12, 16, 28 40 and 52|All randomized patients who took at least one dose of study medication and set who had any post-baseline safety information||Number of patients|||Number
811729|NCT01059773|Secondary|Rate of Adverse Events (AEs), Serious AEs (SAEs) and Deaths During the Study Period|The number of patients with any of the following Treatment Emergent AEs (TEAEs) were summarized through Week 12 and through Week 52, by treatment arm and body weight category (≤100 kg and >100 kg): AE; SAE and Death.|at week 12, 16, 28 40 and 52|All randomized patients who took at least one dose of study medication and set who had any post-baseline safety information.||Number of patients|||Number
811730|NCT01059799|Secondary|Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)|Mean of SMPG after 26 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, before bedtime, at 4 am and before breakfast.|Week 26|The FAS included all randomised subjects.The missing data is imputed using last observation carried forward (LOCF). For 25 subjects all 9-point SMPG values were missing.||mmol/L||Standard Deviation|Mean
811731|NCT01059799|Secondary|Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of nocturnal confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.|Week 0 to Week 26 + 7 days follow up|The Safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||Episodes/100 years of patient exposure|||Number
811732|NCT01059799|Secondary|Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 26 + 7 days follow up|The Safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or its comparator.||Episodes/100 years of patient exposure|||Number
811733|NCT01059799|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Change from baseline in HbA1c after 26 weeks of treatment|Week 0, Week 26|The Full analysis set (FAS) included all randomised subjects and missing data is imputed using last observation carried forward (LOCF).||percentage of glycosylated haemoglobin||Standard Deviation|Mean
811734|NCT01059812|Secondary|Change in Body Weight|Change from baseline in body weight after 26 weeks of treatment.|Week 0, Week 26|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||kg||Standard Deviation|Mean
811735|NCT01059812|Secondary|Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occuring between 00:01 and 05:59 a.m.|Week 0 to Week 26 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||Episodes/100 years of patient exposure|||Number
811736|NCT01059812|Secondary|Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol.|Week 0 to Week 26 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||Episodes/100 years of patient exposure|||Number
811737|NCT01059812|Secondary|Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26|Mean of SMPG at 26 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast.|Week 26|The full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). For 24 subjects all 9-point SMPG values were missing.||mmol/L||Standard Deviation|Mean
811738|NCT01059812|Primary|Change in HbA1c (Glycosylated Haemoglobin) After 26 Weeks of Treatment|Change from baseline in HbA1c after 26 weeks of treatment.|Week 0, Week 26|The full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF).||percentage of glycosylated haemoglobin||Standard Deviation|Mean
811739|NCT01059825|Secondary|Number of Participants Who Discontinued Study Medication Due to an AE|An adverse event is defines as any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. Below table includes all data collected since the first dose of sponsor-provided metformin and excludes a temporary discontinuation of study medication.|Up to 84 days|All participants who received at least 1 dose of treatment (including sponsor-supplied metformin).||Participants|||Number
811740|NCT01059825|Secondary|Number of Participants Who Experienced an Advere Event (AE)|An adverse event is defines as any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. Below table includes all data collected since the first dose of sponsor-provided metformin.|Up to 98 days|All participants who received at least 1 dose of treatment (including sponsor-supplied metformin).||Participants|||Number
811741|NCT01059825|Secondary|Percentage of Participants Achieving HbA1C <6.5% at Week 12|Laboratory measurements were performed after an overnight fast ≥8 hours in duration.|Week 12|Analysis population excludes participants with missing Week 12 HbA1c measurement.||Percentage of participants|||Number
811742|NCT01059825|Secondary|Percentage of Participants Achieving HbA1c <7% at Week 12|Laboratory measurements were performed after an overnight fast ≥8 hours in duration.|Week 12|Analysis population excludes participants with missing Week 12 HbA1c measurement.||Percentage of participants|||Number
811743|NCT01059825|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 8|The change from baseline is the Week 8 FPG minus the Week 0 FPG (LOCF). Laboratory measurements were performed after an overnight fast ≥8 hours in duration.|Baseline and Week 8|Analysis population included randomized participants who were treated, had a baseline fasting plasma glucose measurement and at least 1 post-baseline fasting plasma glucose measurement up to Week 8.||mg/dL||80% Confidence Interval|Least Squares Mean
811744|NCT01059825|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 4|The change from baseline is the Week 4 FPG minus the Week 0 FPG (LOCF). Laboratory measurements were performed after an overnight fast ≥8 hours in duration.|Baseline and Week 4|Analysis population included randomized participants who were treated, had a baseline fasting plasma glucose measurement and at least 1 post-baseline fasting plasma glucose measurement up to Week 4.||mg/dL||80% Confidence Interval|Least Squares Mean
811745|NCT01059825|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 2|The change from baseline is the Week 2 FPG minus the Week 0 FPG (LOCF). Laboratory measurements were performed after an overnight fast ≥8 hours in duration.|Baseline and Week 2|Analysis population included randomized participants who were treated, had a baseline fasting plasma glucose measurement and at least 1 post-baseline fasting plasma glucose measurement up to Week 2.||mg/dL||80% Confidence Interval|Least Squares Mean
811802|NCT01059903|Secondary|AUC(0- ∞) Norm (Apparent Dose)|The AUC(0-inf) norm (apparent dose) is the area under the plasma concentration-time curve from zero up to infinity normalized by apparent dose (mg).|0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h|Pharmacokinetic Set (PKS)||ng/ mL*h/ mg||Standard Deviation|Mean
811746|NCT01059825|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 12|The change from baseline is the Week 12 FPG minus the Week 0 fasting plasma glucose (LOCF). Laboratory measurements were performed after an overnight fast ≥8 hours in duration.|Baseline and Week 12|Analysis population included randomized participants who were treated, had a baseline fasting plasma glucose measurement and at least 1 post-baseline fasting plasma glucose measurement up to Week 12.||mg/dL||80% Confidence Interval|Least Squares Mean
811747|NCT01059825|Secondary|Baseline Fasting Plasma Glucose|Laboratory measurements were performed after an overnight fast ≥8 hours in duration.|Baseline|All randomized participants.||mg/dL||Standard Error|Mean
811748|NCT01059825|Secondary|Change From Baseline in Diastolic Blood Pressure at Week 8|Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 8 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF).|Baseline and Week 8|Analysis population included randomized participants who were treated, had a baseline diastolic blood pressure measurement and at least 1 post-baseline diastolic blood pressure measurement up to Week 8.||mmHg||80% Confidence Interval|Least Squares Mean
811749|NCT01059825|Secondary|Change From Baseline in Diastolic Blood Pressure at Week 4|Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 4 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF).|Baseline and Week 4|Analysis population included randomized participants who were treated, had a baseline diastolic blood pressure measurement and at least 1 post-baseline diastolic blood pressure measurement up to Week 4.||mmHg||80% Confidence Interval|Least Squares Mean
811750|NCT01059825|Secondary|Change From Baseline in Diastolic Blood Pressure at Week 2|Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 2 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF).|Baseline and Week 2|Analysis population included randomized participants who were treated, had a baseline diastolic blood pressure measurement and at least 1 post-baseline diastolic blood pressure measurement up to Week 2.||mmHg||80% Confidence Interval|Least Squares Mean
811751|NCT01059825|Secondary|Change From Baseline in Diastolic Blood Pressure at Week 12|Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 12 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF).|Baseline and Week 12|Analysis population included randomized participants who were treated, had a baseline diastolic blood pressure measurement and at least 1 post-baseline diastolic blood pressure measurement up to Week 12.||mmHg||80% Confidence Interval|Least Squares Mean
811752|NCT01059825|Secondary|Baseline Diastolic Blood Pressure|Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed.|Baseline|All randomized participants.||mmHg||Standard Error|Mean
811753|NCT01059825|Secondary|Change From Baseline in Systolic Blood Pressure at Week 8|Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 8 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF).|Baseline and Week 8|Analysis population included randomized participants who were treated, had a baseline systolic blood pressure measurement and at least 1 post-baseline systolic blood pressure measurement up to Week 8.||mmHg||80% Confidence Interval|Least Squares Mean
811754|NCT01059825|Secondary|Change From Baseline in Systolic Blood Pressure at Week 4|Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 4 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF).|Baseline and Week 4|Analysis population included randomized participants who were treated, had a baseline systolic blood pressure measurement and at least 1 post-baseline systolic blood pressure measurement up to Week 4.||mmHg||80% Confidence Interval|Least Squares Mean
811755|NCT01059825|Secondary|Change From Baseline in Systolic Blood Pressure at Week 2|Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 2 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF).|Baseline and Week 2|Analysis population included randomized participants who were treated, had a baseline systolic blood pressure measurement and at least 1 post-baseline systolic blood pressure measurement up to Week 2.||mmHg||80% Confidence Interval|Least Squares Mean
811756|NCT01059825|Secondary|Change From Baseline in Systolic Blood Pressure at Week 12|Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 12 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF).|Baseline and Week 12|Analysis population included randomized participants who were treated, had a baseline systolic blood pressure measurement and at least 1 post-baseline systolic blood pressure measurement up to Week 12.||mmHg||80% Confidence Interval|Least Squares Mean
811757|NCT01059825|Secondary|Baseline Systolic Blood Pressure|Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed.|Baseline|All randomized participants.||mmHg||Standard Error|Mean
811758|NCT01059825|Secondary|Percent Change From Baseline in Body Weight at Week 8|The percent change from baseline is the ([Week 8 body weight minus the Week 0 body weight] divided by the Week 0 body weight) X 100 (LOCF).|Baseline and Week 8|Analysis population included randomized participants who were treated, had a baseline body weight measurement and at least 1 post-baseline body weight measurement up to Week 8.||Percent change||80% Confidence Interval|Least Squares Mean
811759|NCT01059825|Secondary|Percent Change From Baseline in Body Weight at Week 4|The percent change from baseline is the ([Week 4 body weight minus the Week 0 body weight] divided by the Week 0 body weight) X 100 (LOCF).|Baseline and Week 4|Analysis population included randomized participants who were treated, had a baseline body weight measurement and at least 1 post-baseline body weight measurement up to Week 4.||Percent change||80% Confidence Interval|Least Squares Mean
811760|NCT01059825|Secondary|Percent Change From Baseline in Body Weight at Week 2|The percent change from baseline is the ([Week 2 body weight minus the Week 0 body weight] divided by the Week 0 body weight) X 100 (LOCF).|Baseline and Week 2|Analysis population included randomized participants who were treated, had a baseline body weight measurement and at least 1 post-baseline body weight measurement up to Week 2.||Percent change||80% Confidence Interval|Least Squares Mean
811761|NCT01059825|Secondary|Percent Change From Baseline in Body Weight at Week 12|The percent change from baseline is the ([Week 12 body weight minus the Week 0 body weight] divided by the Week 0 body weight) X 100 (LOCF).|Baseline and Week 12|Analysis population included randomized participants who were treated, had a baseline body weight measurement and at least 1 post-baseline body weight measurement up to Week 12.||Percent change||80% Confidence Interval|Least Squares Mean
811762|NCT01059825|Secondary|Baseline Body Weight||Baseline|All randomized participants.||kg||Standard Error|Mean
811763|NCT01059825|Secondary|Change From Baseline in HbA1c at Week 8|HbA1c is measured as percent. The change from baseline is the Week 8 HbA1c percent minus the Week 0 HbA1c percent (LOCF).|Baseline and Week 8|Analysis population included randomized participants who were treated, had a baseline HbA1c measurement and at least 1 post-baseline HbA1c measurement up to Week 8.||Percent||80% Confidence Interval|Least Squares Mean
811764|NCT01059825|Secondary|Change From Baseline in HbA1c at Week 4|HbA1c is measured as percent. The change from baseline is the Week 4 HbA1c percent minus the Week 0 HbA1c percent (LOCF).|Baseline and Week 4|Analysis population included randomized participants who were treated, had a baseline HbA1c measurement and at least 1 post-baseline HbA1c measurement up to Week 4.||Percent||80% Confidence Interval|Least Squares Mean
811765|NCT01059825|Secondary|Change From Baseline in HbA1C at Week 2|HbA1c is measured as percent. The change from baseline is the Week 2 HbA1c percent minus the Week 0 HbA1c percent (LOCF).|Baseline and Week 2|Analysis population included randomized participants who were treated, had a baseline HbA1c measurement and at least 1 post-baseline HbA1c measurement up to Week 2.||Percent||80% Confidence Interval|Least Squares Mean
811766|NCT01059825|Primary|Change From Baseline in HbA1c at Week 12|HbA1c is measured as percent. The change from baseline is the Week 12 HbA1c percent minus the Week 0 HbA1c percent (last observation carried forward [LOCF]).|Baseline and Week 12|Analysis population included randomized participants who were treated, had a baseline HbA1c measurement and at least 1 post-baseline HbA1c measurement up to Week 12.||Percent||80% Confidence Interval|Least Squares Mean
811767|NCT01059825|Primary|Baseline Hemoglobin A1c (HbA1c)|HbA1c is measured as percent.|Baseline|All randomized participants.||Percent||Standard Error|Mean
811768|NCT01059851|Primary|Number of Participants Who Discontinued Study Due to an AE|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug.|From administration of study drug through 14 days after administration of study drug|All Treated Participants||participants|||Number
811769|NCT01059851|Primary|Number of Participants With an Adverse Event (AE)|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug.|From administration of study drug through 14 days after administration of study drug|All Treated Participants||participants|||Number
811770|NCT01059851|Primary|AUC(0-∞) After Single Dose Suvorexant: Moderate and Mild Renal Impairment Participants Versus Healthy Participants (Part II)|Overall exposure was assessed by the area under the plasma concentration versus time curve from time zero to infinity (AUC[0-∞]). AUC(0-∞) was calculated as the sum of the AUC to the last time point with a detectable plasma concentration (AUC[0-last]) and the extrapolated area given by the quotient of the last detectable concentration and the apparent terminal rate constant (λ).|Predose and 0.5, 1, 2, 4, 6, 9, 12, 16, 24, 48, 72, 96, and 120 hours post-dose|Per protocol, the decision to conduct Part II of study in moderate/mild renal impairment participants was conditional on results of AUC (0-∞) analysis in severe renal impairment participants (Part I). Based on results of Part I of study, Part II was not conducted and AUC(0-∞) analysis in moderate/mild renal impairment was not done.|||||
811771|NCT01059851|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to Infinity (0-∞) After Single Dose Suvorexant: Severe Renal Impairment Participants Versus Healthy Participants (Part I)|Overall exposure was assessed by the area under the plasma concentration versus time curve from time zero to infinity (AUC[0-∞]). AUC(0-∞) was calculated as the sum of the AUC to the last time point with a detectable plasma concentration (AUC[0-last]) and the extrapolated area given by the quotient of the last detectable concentration and the apparent terminal rate constant (λ).|Predose and 0.5, 1, 2, 4, 6, 9, 12, 16, 24, 48, 72, 96, and 120 hours post-dose|All Treated Participants||μM•hr||95% Confidence Interval|Geometric Mean
811772|NCT01059864|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI)|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 functional categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3, 0=least functional difficulty and 3=extreme functional difficulty.|Day 0, Week 6 (Baseline), 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).||units on a scale||Standard Deviation|Mean
811773|NCT01059864|Secondary|Patient's Global Assessment (PtGA) of Arthritis Pain|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0-100 mm visual analog scale where 0=no pain and 100=most severe pain."|Day 0, Week 6 (Baseline), Week 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).||mm||Standard Deviation|Mean
811774|NCT01059864|Secondary|Physician's Global Assessment (PhysGA) of Arthritis Pain|The physician evaluated participants disease signs, functional capacity and physical examination independent of the patient’s global assessment of arthritis. Physician’s response was recorded using 0-100 mm visual analog scale (VAS), where 0=no pain and 100=most severe pain.|Day 0, Week 6 (Baseline), Week 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).||mm||Standard Deviation|Mean
811803|NCT01059903|Secondary|AUC(0-tz) Norm (Body Weight) of Unconjugated Rotigotine|The AUC(0-tz) norm (BW) is the area under the plasma concentration-time curve from zero up to the last analytically quantifiable concentration normalized by body weight (kg).|0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h|Pharmacokinetic Set (PKS)||ng*h*kg/ mL||Standard Deviation|Mean
811775|NCT01059864|Secondary|Patient Assessment of Arthritis Pain|Participants assessed the severity of their arthritis pain using a 100 millimeter (mm) visual analog scale (VAS). The scale ranged from 0 (no pain) to 100 (most severe pain), measurement on a scale corresponds to the magnitude of their pain.|Day 0, Week 6 (Baseline), 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).||mm||Standard Deviation|Mean
811776|NCT01059864|Secondary|Erythrocyte Sedimentation Rate (ESR)|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.|Day 0, Week 6 (Baseline), 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).||mm/hr||Standard Deviation|Mean
811777|NCT01059864|Secondary|C-Reactive Protein (CRP)|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. Normal range is 1-3 milligram per liter (mg/L).|Day 0, Week 6 (Baseline), 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).||mg/L||Standard Deviation|Mean
811778|NCT01059864|Secondary|Swollen-Joint Count|Swollen joint count (SJC): an assessment of 66 joints (upper body, upper extremity, and lower extremity). Each joint was assessed for swelling using the following scale: Present/Absent/Not Done/Not Applicable (for artificial joints).|Day 0, Week 6 (Baseline), Week 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).||swollen joints||Standard Deviation|Mean
811779|NCT01059864|Secondary|Tender-Joint Count|Tender joint count (TJC) is an assessment of 68 joints (upper body, upper extremity, and lower extremity). Each joint’s response to pressure/motion was assessed using the following scale: Present/Absent/Not Done/Not Applicable (for artificial joints).|Day 0, Week 6 (Baseline), 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).||tender joints||Standard Deviation|Mean
811780|NCT01059864|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response|ACR70 responses were defined as greater than or equal to 70% improvement in tender or swollen joint counts and 70% improvement in 3 of the 5 remaining ACR-core set measures: 1) physician's global assessment of disease activity, 2) participants assessment of disease activity, 3) participants assessment of pain, 4) participants assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.|Week 6 (Baseline), 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).||percentage of participants|||Number
811781|NCT01059864|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response|ACR50 responses were defined as greater than or equal to 50% improvement in tender or swollen joint counts and 50% improvement in 3 of the 5 remaining ACR-core set measures: 1) physician's global assessment of disease activity, 2) participants assessment of disease activity, 3) participants assessment of pain, 4) participants assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.|Week 6 (Baseline), 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).||percentage of participants|||Number
811782|NCT01059864|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response|ACR20 responses were defined as greater than or equal to 20% improvement in tender or swollen joint counts and 20% improvement in 3 of the 5 remaining ACR-core set measures: 1) physician's global assessment of disease activity, 2) participants assessment of disease activity, 3) participants assessment of pain, 4) participants assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.|Week 6 (Baseline), 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).||percentage of participants|||Number
811783|NCT01059864|Secondary|Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])|DAS28-4 (ESR) was calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) [mm/hr] and patient's global assessment (PtGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging from 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28-4 (ESR) <=3.2 indicated low disease activity, DAS28-4 (ESR) >3.2 to 5.1 indicated moderate to high disease activity.|Day 0, Week 6 (Baseline), 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo). Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
811784|NCT01059864|Secondary|Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR])|DAS28-3 (ESR) was calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count and the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]). DAS28-3 (ESR) <=3.2 indicated low disease activity, DAS28-3 (ESR) >3.2 to 5.1 indicated moderate to high disease activity.|Day 0, Week 6 (Baseline), 12|Since DAS28-3(CRP) and DAS28-4(ESR) are summarized, data for DAS28-3(ESR) was collected and reported in individual participant listings, but not statistically summarized for analysis as planned.|||||
811785|NCT01059864|Secondary|Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])|DAS28-4 (CRP) was calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, C-reactive protein (CRP) [mg/L] and patient's global assessment (PtGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28-4 [CRP] <=3.2 indicated low disease activity, DAS28-4 [CRP] >3.2 to 5.1 indicated moderate to high disease activity and DAS28 less than 2.6 indicates remission.|Day 0, Week 6 (Baseline), 12|Since DAS28-3(CRP) and DAS28-4(ESR) are summarized, data for DAS28-4(CRP) was collected and reported in individual participant listings, but not statistically summarized for analysis as planned.|||||
811786|NCT01059864|Secondary|Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])|DAS28-3 (CRP) was calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count and the CRP (milligram per liter [mg/L]). DAS28-3 (CRP) less than or equal to (<=)3.2 indicated low disease activity, DAS28-3 (CRP) more than (>) 3.2 to 5.1 indicated moderate to high disease activity.|Day 0, Week 6 (Baseline), 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).||units on a scale||Standard Deviation|Mean
811787|NCT01059864|Secondary|12-Hours Fasting Lipid Profile: Level of High Density Lipoprotein Cholesterol (HDL-C) Particles|Participants were required to fast for 12 hours prior to sampling for lipid profile which included following parameters: total, large, medium and small HDL-C particles.|Day 0, Week 2, 6 (Baseline), 10, 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).||micromole per liter (mcmol/L)||Standard Deviation|Mean
811788|NCT01059864|Secondary|12-Hours Fasting Lipid Profile: Level of Lipoprotein Particles|Participants were required to fast for 12 hours prior to sampling for lipid profile which included following parameters: total and large VLDL-C and chylomicron particles (VLDLCP), medium and small VLDL-C particles; total, large, medium and small LDL-C particles; and intermediate density lipoprotein (IDL).|Day 0, Week 2, 6 (Baseline), 10, 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).||nanomoles per liter (nmol/L)||Standard Deviation|Mean
811789|NCT01059864|Secondary|12-Hours Fasting Lipid Profile: Particle Size of Lipoproteins|Participants were required to fast for 12 hours prior to sampling for lipid profile which included following parameters: plasma lipoprotein VLDL-C, LDL-C and HDL-C particles size.|Day 0, Week 2, 6 (Baseline), 10, 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).||nanometer (nm)||Standard Deviation|Mean
811790|NCT01059864|Secondary|12-Hours Fasting Lipid Profile|Participants were required to fast for 12 hours prior to sampling for lipid profile which included following parameters: LDL-C, high-density lipoprotein-cholesterol (HDL-C), very low density lipoprotein-cholesterol (VLDL-C), total cholesterol, apolipoprotein A-1, apolipoprotein B, triglycerides (TGs) and Non-HDL-C.|Day 0, Week 2, 6 (Baseline), 10, 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).||mg/dL||Standard Deviation|Mean
811791|NCT01059864|Secondary|Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12||Baseline (Week 6), Week 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo). Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||milligram per deciliter (mg/dL)||Standard Error|Least Squares Mean
811792|NCT01059864|Primary|Percent Change From Baseline (Week 6) in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Week 12||Baseline (Week 6), Week 12|Full analysis set (FAS) included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo). Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||percent change||Standard Error|Least Squares Mean
811793|NCT01059903|Secondary|Apparent Dose|Apparent dose of unconjugated rotigotine in mg. The apparent dose was calculated by subtraction of the determined residual content of each rotigotine patch from the nominal content of rotigotine in the patch.|24 hours|Pharmacokinetic Set (PKS)||mg||Standard Deviation|Mean
811794|NCT01059903|Secondary|Apparent Total Body Clearance (CL/f) of Unconjugated Rotigotine|The CL/f of unconjugated rotigotine is the apparent total body clearance.|0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h|Pharmacokinetic Set (PKS)||L/ h||Standard Deviation|Mean
811795|NCT01059903|Secondary|Terminal Half-Life (t1/2) of Unconjugated Rotigotine|the t1/2 of unconjugated rotigotine is the terminal half-life, calculated as t1/2=ln2/ λz.|0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h|Pharmacokinetic Set (PKS)||hours (h)||Standard Deviation|Mean
811796|NCT01059903|Secondary|Rate Constant of Elimination (λz) of Unconjugated Rotigotine|The λz of unconjugated rotigotine is the rate constant of elimination.|0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h|Pharmacokinetic Set (PKS)||1/ h||Standard Deviation|Mean
811797|NCT01059903|Secondary|Mean Residence Time (MRT) of Unconjugated Rotigotine|The MRT is the mean residence time.|0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h|Pharmacokinetic Set (PKS)||hours (h)||Standard Deviation|Mean
811798|NCT01059903|Secondary|Tmax of Unconjugated Rotigotine|The tmax is the time to reach maximum plasma concentration after patch application.|0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h|Pharmacokinetic Set (PKS)||hours (h)||Standard Deviation|Mean
811799|NCT01059903|Secondary|Cmax, Norm (Body Weight) of Unconjugated Rotigotine|The Cmax, norm (BW) is the maximum plasma concentration normalized by body weight (kg).|0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h|Pharmacokinetic Set (PKS)||ng/ mL*kg||Standard Deviation|Mean
811800|NCT01059903|Secondary|Cmax, Norm (Apparent Dose) of Unconjugated Rotigotine|The Cmax, norm (apparent dose) is the maximum plasma concentration normalized by apparent dose (mg).|0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h|Pharmacokinetic Set (PKS)||ng/ mL/ mg||Standard Deviation|Mean
811801|NCT01059903|Secondary|AUC(0- ∞) Norm (Body Weight)|The AUC(0-inf) norm (BW) is the area under the plasma concentration-time curve from zero up to infinity normalized by body weight (kg).|0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h|Pharmacokinetic Set (PKS)||ng*h*kg/ mL||Standard Deviation|Mean
811804|NCT01059903|Secondary|AUC(0-tz) Norm (Apparent Dose) of Unconjugated Rotigotine|The AUC(0-tz) norm (apparent dose) is the area under the plasma concentration-time curve from zero up to the last analytically quantifiable concentration normalized by apparent dose (mg).|0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h|Pharmacokinetic Set (PKS)||ng/ mL*h/ mg||Standard Deviation|Mean
811805|NCT01059903|Primary|AUC(0- ∞) of Unconjugated Rotigotine|The AUC(0- ∞) is the area under the plasma concentration-time curve from zero up to infinity|0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h|Pharmacokinetic Set (PKS)||ng/ mL*h||Standard Deviation|Mean
811806|NCT01059903|Primary|Cmax of Unconjugated Rotigotine|The Cmax is the maximum plasma concentration.|0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h|Pharmacokinetic Set (PKS)||ng/ mL||Standard Deviation|Mean
811807|NCT01059903|Primary|AUC(0-tz) of Unconjugated Rotigotine|The AUC(0-tz) is the area under the concentration-time curve from zero up to the last analytically quantifiable concentration.|0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h|Pharmacokinetic Set (PKS)||ng/ mL*h||Standard Deviation|Mean
811808|NCT01059994|Secondary|Protein Synthesis|Skeletal muscle protein synthesis, measured as the fractional synthesis rate (the percent of the total synthesized per unit time)|2 weeks|||% synthesized of total/hour||Standard Deviation|Mean
811809|NCT01059994|Primary|Muscle Fatigue|successful isokinetic knee extension repetitions, % baseline day repetitions|2 weeks|||successful repetitions (% baseline day)||Standard Deviation|Mean
811810|NCT01060007|Secondary|Determine Quality of Anorectal Function|"Anorectal function was measured by the participant's response to the FACT-C questionnaire question I have control of my bowels. The answers ranged from 0=not at all to 4=very much."|Up to 1 year|Participants who had an ostomy were not included in this outcome measure. Participants who did not complete FACT-C questionnaire at a specific timepoint were not included in that timepoint.||Participants|||Count of Participants
811811|NCT01060007|Secondary|Freedom From Disease Relapse|Kaplan-Meier projections.|30 months|These include all cMO evaluable cases only.||percentage of participants||95% Confidence Interval|Number
811812|NCT01060007|Secondary|Rate of Locoregional Control||1 year|||percentage of participants|||Number
811813|NCT01060007|Secondary|Rate of Overall Control||1 year|||percentage of participants|||Number
811814|NCT01060007|Secondary|Local Control|"Kaplan-Meier projections
Local control = control of primary tumor"|30 months|||percentage of participants||95% Confidence Interval|Number
811815|NCT01060007|Secondary|Incidence of Post Chemoradiotherapy Grade 3 or Higher Morbidity||1 year (completion of all treatment)|||participants|||Number
811816|NCT01060007|Secondary|Incidence of Any Late Grade 3 or Higher Morbidity||Preoperative (mean time from start of radiation to surgery 17.3 weeks (SD +/- 2.9 weeks)|One patient was inevaluable for primary objectives because patient withdrew consent after completing radiation therapy, refused chemotherapy, and underwent a lesion resection 7 weeks after radiation therapy.||participants|||Number
811817|NCT01060007|Primary|Preoperative Gastrointestinal Morbidity|As measured by participants who experience grade 3 or higher gastrointestinal morbidity|Mean number of weeks before surgery 17.3 (SD +/- 2.9 weeks)|One patient was inevaluable for primary objectives because patient withdrew consent after completing radiation therapy, refused chemotherapy, and underwent a lesion resection 7 weeks after radiation therapy.||participants|||Number
811818|NCT01060007|Primary|Rate of T Stage Downstaging|T stage downstaging is defined as clinical pretreatment American Joint Committee on Cancer T stage (cT) being greater than pathologic T stage at surgery (ypT).|Mean number of weeks before surgery 17.3 (SD +/- 2.9 weeks)|||percentage of participants|||Number
811819|NCT01060059|Secondary|Factors of Higher Creatinine, Higher Fasting High Density Lipoprotein (HDL) Cholesterol, Higher Fasting Cholesterol, and Higher Fasting Triglycerides Which Were Associated With Treatment Choice at Baseline|Factors of higher creatinine: 1 milligram per deciliter higher (mg/dL) and higher fasting lipids (HDL cholesterol: 1 mg/dL higher; total cholesterol: 1 mg/dL higher; triglycerides: 1 mg/dL higher) were analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor. Creatinine and fasting lipids were measured in milligrams per deciliter (mg/dL).|baseline|Full analysis set (FAS) population: all patients who provided consent to release information and who fulfilled the study entry criteria. FASS=444 and 438 in each arm respectively but the number of patients with creatinine and fasting lipids data at baseline varied. N is presented with each category.||mg/dL||Standard Deviation|Mean
811820|NCT01060059|Secondary|Factor of Greater Height Associated With Treatment Choice at Baseline|Factor of greater height (1 centimeter higher) was analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor. Height was measured in centimeters (cm) .|baseline|"Full analysis set (FAS) population: all patients who provided consent to release information and who fulfilled the study entry criteria.
FAS for basal insulin arm=438 but one patient did not provide height data so n=437."||cm||Standard Deviation|Mean
811821|NCT01060059|Secondary|Factor of Higher Body Mass Index (BMI) Associated With Treatment Choice at Baseline|Factor of higher body mass index (BMI) (1 kilogram per meter squared (kg/m^2) higher) was analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor. BMI measured as kg/m^2.|baseline|"Full analysis set (FAS) population: all patients who provided consent to release information and who fulfilled the study entry criteria.
FAS for basal insulin arm=438 but one patient did not have data in this arm so n=437."||kg/m^2||Standard Deviation|Mean
813407|NCT01078584|Other Pre-specified|Number of Participants Adding Concomitant Cardiovascular Medications at 6 Months|Presented by type of medication added.|6 Months|Evaluable participants (all participants in the ITT cohort with available data at given time point).||participants|||Number
811822|NCT01060059|Secondary|Factor of Older Age Associated With Treatment Choice at Baseline|Older age (1 year older) was analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor. Age was measured in years.|baseline|Full analysis set (FAS) population: all patients who provided consent to release information and who fulfilled the study entry criteria.||years||Standard Deviation|Mean
811823|NCT01060059|Secondary|Factor of Longer Duration of Diabetes Associated With Treatment Choice at Baseline|The Factor of longer duration of diabetes at baseline (diagnosed 1 year longer) was analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor. Duration of diabetes was measured in years since the date of diabetes diagnosis.|baseline|Full analysis set (FAS) population: all patients who provided consent to release information and who fulfilled the study entry criteria.||years||Standard Deviation|Mean
811824|NCT01060059|Secondary|Factor of 1 Percent (%) Higher Baseline HbA1c Associated With Treatment Choice at Baseline|Factor of 1% higher baseline HbA1c (from most recent HbA1c) was analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor. HbA1c was measured as a percent of normal (%).|baseline|"Full analysis set (FAS) population: all patients who provided consent to release information and who fulfilled the study entry criteria.
FAS=444, however 1 patient in the exenatide arm was missing data for the most recent HbA1c at baseline so n=443."||Percentage of normal||Standard Deviation|Mean
811825|NCT01060059|Secondary|Factors of Gender, Baseline Presence of Medical Conditions, and Previous Gastrointestinal Symptoms Associated With Treatment Choice at Baseline|Number of patients per arm who were evaluated in 3 factors at baseline (gender, presence of medical conditions, and previous gastrointestinal symptoms) were analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor.|baseline|All patients consented to release information; fulfilled study entry criteria. Analyses conducted on baseline arm assignment, irrespective of later treatment changes. Only those assigned to an arm were included. Missing values for numeric covariates replaced with means; categorical ones, with modes.||participants|||Number
811826|NCT01060059|Secondary|Percentage of Patients With Hypoglycemia Episodes Between Baseline and Month 12|"Percentage of patients with Hypoglycemia Episodes Between Baseline and Month 12.
All episodes consistent with hypoglycemia with or without a confirmatory blood glucose reading were collected."|Baseline to Month 12|"All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.
Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes"||percentage of patients|||Number
811827|NCT01060059|Secondary|Changes in Systolic Blood Pressure Between Baseline and Month 12|Changes in Systolic Blood Pressure Between Baseline and Month 12|Baseline, Month 12|"All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.
Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes"||mmHg||Standard Deviation|Mean
811828|NCT01060059|Secondary|Changes in Diastolic Blood Pressure Between Baseline and Month 12|Changes in Diastolic Blood Pressure Between Baseline and Month 12|Baseline, Month 12|"All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.
Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes"||mmHg||Standard Deviation|Mean
811829|NCT01060059|Secondary|Changes in Fasting Triglycerides Between Baseline and Month 12|Changes in Fasting Triglycerides Between Baseline and Month 12|Baseline, Month 12|"All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.
Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes"||mg/dL||Standard Deviation|Mean
811830|NCT01060059|Secondary|Changes in Fasting LDL Between Baseline and Month 12|Changes in Fasting LDL Between Baseline and Month 12|Baseline, Month 12|"All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.
Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes"||mg/dL||Standard Deviation|Mean
811831|NCT01060059|Secondary|Changes in Fasting HDL Between Baseline and Month 12|Changes in Fasting HDL Between Baseline and Month 12|Baseline, Month 12|"All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.
Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes"||mg/dL||Standard Deviation|Mean
811832|NCT01060059|Secondary|Changes in Fasting Total Cholesterol Between Baseline and Month 12|Changes in Fasting Total Cholesterol Between Baseline and Month 12|Baseline, Month 12|"All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.
Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes"||mg/dL||Standard Deviation|Mean
811833|NCT01060059|Secondary|Percentage of Patients Achieving a Weight Decrease >=5% Between Baseline and Month 12|Percentage of Patients Achieving a Weight Decrease >=5% between Baseline and Month 12|Baseline, Month 12|"All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.
Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes"||percentage of patients|||Number
811834|NCT01060059|Secondary|Percentage of Patients Achieving a Weight Decrease >=3% Between Baseline and Month 12|Percentage of Patients Achieving a Weight Decrease >=3% between Baseline and Month 12|Baseline, Month 12|"All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.
Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes"||percentage of patients|||Number
811835|NCT01060059|Secondary|Changes in Weight From Baseline to Month 12|Changes in Weight From Baseline to Month 12|Baseline, Month 12|"All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.
Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes"||kg||Standard Deviation|Mean
811836|NCT01060059|Secondary|Percentage of Patients Achieving HbA1c Concentration <6.5% at Month 12|Percentage of Patients Achieving HbA1c Concentration <6.5% at Month 12|Month 12|"All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.
Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes"||percentage of patients|||Number
811837|NCT01060059|Secondary|Percentage of Patients Achieving HbA1c Concentration <=7.0% at Month 12|Percentage of Patients Achieving HbA1c Concentration <=7.0% at Month 12|Month 12|"All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.
Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes"||percentage of patients|||Number
811838|NCT01060059|Secondary|Percentage of Patients With HbA1c Reduction From Baseline >= 1.0% at Month 12|Percentage of Patients with HbA1c Reduction from Baseline >= 1.0% at Month 12|Baseline, Month 12|"All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.
Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes"||percentage of patients|||Number
811839|NCT01060059|Secondary|Changes in Fasting Blood Glucose From Baseline to Month 12|Changes in Fasting Blood Glucose From Baseline to Month 12|Baseline, Month 12|"All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.
Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes."||mg/dL||Standard Deviation|Mean
811840|NCT01060059|Secondary|Changes in HbA1c From Baseline to Month 12|Changes in HbA1c from Baseline to Month 12|Baseline, Month 12|"All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.
Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes."||percent||Standard Deviation|Mean
811841|NCT01060059|Primary|Percentage of Patients Who Achieved Glycemic Target of HbA1c ≤ 7.0% With Minimal Weight Gain (≤ 1 Kg) at Month 12.|Percentage of patients who achieved glycemic target of HbA1c ≤ 7.0% with minimal weight gain (≤ 1 Kg) at month 12.|Baseline, Month 12|"All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.
Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes."||percentage of patients||95% Confidence Interval|Number
811842|NCT01067716|Other Pre-specified|Induced Manifest Refractive Astigmatism Greater Than 2.0 D of Absolute Cylinder Power||1 Year|||percentage of eyes|Participants|95% Confidence Interval|Number
811843|NCT01067716|Other Pre-specified|Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA)|After surgery, with or without best spectacle prescription the subject is not expected to see worse than before surgery. As a metric for this safety endpoint, losses of 2 lines of vision on a standard eye chart, with best spectacle correction, after surgery compared to pre-operative baseline shall be evaluated. For example 20/20 is typically considered best vision and 2 lines worse than this will be 20/32).|1 Year|||percentage of eyes|Participants|95% Confidence Interval|Number
811844|NCT01067716|Other Pre-specified|Percent Manifest Refraction Spherical Equivalent Within 1.0D|Manifest refraction spherical equivalent is the required spectacle (or glass) prescription.|1 Year|As a measure of effectiveness of LASIK treatment with VSS, the required spectacle prescription, also called manifest refraction, will be measured under standardized conditions such as 4 meter testing distance, controlled ambient room lighting and standard eye charts.||percentage of eyes|Participants|95% Confidence Interval|Number
811845|NCT01067716|Primary|Percent of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better||1 Year|As a measure of effectiveness of LASIK treatment with VSS, distance visual performance without spectacles, clinically measured as Uncorrected Visual Acuity (UCVA) will be measured under standardized conditions such as 4 meter testing distance, controlled ambient room lighting and standard eye charts.||percentage of eyes|Participants|95% Confidence Interval|Number
811846|NCT01067768|Secondary|Catheter Days|The duration of catheterization|withdrawal of the catheter|Analysis by intention to treat||Days||Inter-Quartile Range|Median
811847|NCT01067768|Primary|Rate of Catheter-associated Urinary Tract Infection||Until 7 days after the withdrawal of the catheter or at discharge (whichever comes first)|Analysis by intention to treat||infections per 1000 days||95% Confidence Interval|Number
811848|NCT01067781|Secondary|Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: (1) Geometric Mean Titers (2) Geometric Mean Fold Ratios (3) Seroconversion Rates||Day 0 to Day 180||||||
811849|NCT01067781|Primary|Characterization and Comparison of the Safety of the TD Vaccine System: (1) Solicited and Unsolicited Adverse Events (AEs) (2) Clinical Laboratory Safety (3) Serious AEs|Erythema, rash, pain, pruritus, hyperpigmentation, hypopigmentation and edema were solicited local AEs for the duration of the study. Fever, malaise, headache, and diarrhea were solicited systemic AEs for the first seven days following each vaccination; events reported outside this time frame were considered non-solicited.|Day 0 to Day 180|||participants|||Number
831857|NCT01243320|Primary|Change in Carbon Dioxide Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days|||mmol/L||95% Confidence Interval|Mean
811850|NCT01067846|Primary|Treatment Retention – Number of Visits During Treatment|Number of treatment visits attended prior to discontinuation of treatment|Treatment sessions included 3 visits per week for 4 weeks|Total possible sessions attended = 180 per arm. Some participants did not complete all sessions, therefore the units analyzed will not match the total possible.||visits|Participants|Standard Deviation|Mean
811851|NCT01067846|Primary|Drug Abstinence During Treatment and at Follow up Visits|Percentage of the overall number of drug abstinences of participants measured by urine drug testing|Participants provided urine samples for drug testing during treatment which occurred 3 times per week for 4 weeks, at the end of treatment, and at a 1 and 2 month follow up visit|Total possible urine samples = 225 per arm. Not all participants stayed in treatment, therefore the total units analyzed will not match the total possible.||percentage of drug abstinences|Participants||Number
811852|NCT01068158|Secondary|Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)|"Severe skin/scalp irritations were defined as follows:
Severe Pruritus - Nearly constant, frequent scratching, very bothersome; Severe Erythema - large areas of the scalp are red; Severe Excoriation - Widespread breaking of the skin involving most of the scalp; Severe Pyoderma - Lesions with crusting or other evidence of infection, involving most of the scalp."|Day 2 up to Day 15 post-application|Skin/scalp irritation was assessed in the Intent-to-Treat (Safety) population.||Participants|||Number
811853|NCT01068158|Secondary|Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control)|"Adverse events were defined and classified as follows:
'Mild' - Awareness of signs or symptoms, but easily tolerated; 'Moderate' - Discomfort to a degree that adverse event/adverse drug reaction causes interference with normal daily life activities and/or requires medication; 'Severe' - Incapacity with regard to work or usual daily life activities. Requires medical attention/intervention."|Day 2 up to Day 15 post-application|Adverse events were assessed in the Intent-to-treat (Safety) population. Any participant with live lice on or after Day 2 received an FDA approved head lice treatment and was classified as a treatment failure, imputed as such for remaining assessments.||Participants|||Number
811854|NCT01068158|Primary|Percentage of All Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 15 Post-treatment With Either Ivermectin or Placebo (Vehicle Control)|Treatment success, defined as absence of live lice, was assessed in all subjects. Treatment success was assessed by last observation carried forward (LOCF) imputation and treatment failure imputation.|Day 2 up to Day 15 post-application|Treatment success was assessed in the Intent-to-treat 2 (All Participants) population. Any participant with live lice on or after Day 2 received an FDA approved head lice treatment and was classified as a treatment failure, imputed as such for remaining assessments.||Percent of Participants|||Number
811855|NCT01068158|Primary|Percentage of Index Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 15 Post-treatment With Either Ivermectin or Placebo (Vehicle Control)|Treatment success, defined as absence of live lice, was assessed in index subjects, defined as the youngest person within each household who had at least 3 live lice present at Screening (Day 1). Treatment success was assessed by last observation carried forward (LOCF) imputation and treatment failure imputation.|Day 2 up to Day 15 post-application|Treatment success was assessed in a subset of the Intent-to-treat population (Index participants). Any participant with live lice on or after Day 2 received an FDA approved head lice treatment and was classified as a treatment failure, imputed as such for remaining assessments.||Percent of Participants|||Number
811856|NCT01068262|Secondary|Number of Participants Who Discontinued Study Treatment Due to an AE|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR’s product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of the SPONSOR’s product, is also an AE. The study determined if the number of participants who discontinued treatment with Odanacatib 50 mg Qw for 4 consecutive weeks due to AEs was sufficiently low to permit continued clinical investigation.|Up to Week 4|All randomized participants who received ≥1 dose of study treatment||Participants|||Number
811857|NCT01068262|Secondary|Number of Participants With At Least One Adverse Event (AE) in the Baseline, Treatment, or Post-Treatment Periods|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR’s product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of the SPONSOR’s product, is also an AE. The study determined if the number of AEs experienced by participants receiving Odanacatib 50 mg Qw for 4 consecutive weeks was sufficiently low to permit continued clinical investigation. In addition to AEs during the treatment period and post-treatment follow-up period, AEs may have occurred prior to treatment in screened participants as a result of urine and blood sampling at Baseline.|Up to Day 58|All randomized participants who received ≥1 dose of study treatment||Participants|||Number
811858|NCT01068262|Secondary|Apparent Terminal Half-Life (t1/2) of Odanacatib in Healthy Male and Postmenopausal Female Participants at Week 4|Blood samples were obtained predose on Day 1 (Baseline) and at various timepoints up to 336 hr postdose on Day 22 (Week 4) to determine the similarity of the apparent t1/2 of odanacatib 50 mg administered Qw for 4 weeks in healthy males and postmenopausal females. Harmonic mean, jack-knife standard deviation reported for apparent terminal t1/2.|Baseline, Week 4 (1, 2, 6, 12, 24, 48, 72, 96, 120, 144, 168, 240, and 336 hours post-dose)|The population of male and postmenopausal female participants who received Qw treatment with Odanacatib 50 mg for 4 weeks and were compliant with the protocol.||hr||Standard Deviation|Mean
811859|NCT01068262|Secondary|Overall Time to Maximum Concentration (Tmax) of Odanacatib in Healthy Male and Postmenopausal Female Participants at Week 4|Blood samples were obtained predose on Day 1 (Baseline) and at various timepoints up to 336 hr postdose on Day 22 (Week 4) to determine the similarity of steady-state Tmax of odanacatib 50 mg administered Qw for 4 weeks in healthy males and postmenopausal females.|Baseline, Week 4 (1, 2, 6, 12, 24, 48, 72, 96, 120, 144, 168, 240, and 336 hours post-dose)|The population of male and postmenopausal female participants who received Qw treatment with Odanacatib 50 mg for 4 weeks and were compliant with the protocol.||hr||Full Range|Median
824781|NCT01178268|Secondary|Follow-up In-segment Percent Diameter Stenosis (DS)||≥13 months|The number of participants with angiographic follow up available was analysed.||percent Diameter stenosis|Participants|Standard Deviation|Mean
811860|NCT01068262|Secondary|Concentration of Odanacatib at 168 Hours (C168hr) in Healthy Male and Postmenopausal Female Participants at Week 4|Blood samples were obtained at 168 hours postdose on Day 22 (Week 4) to determine the similarity of steady-state C168hr (trough concentrations) of odanacatib 50 mg administered Qw for 4 weeks in healthy males and postmenopausal females.|Week 4 (168 hours postdose)|The population of male and postmenopausal female participants who received Qw treatment with Odanacatib 50 mg for 4 weeks and were compliant with the protocol.||nM||95% Confidence Interval|Geometric Mean
811861|NCT01068262|Secondary|Overall Maximum Concentration (Cmax) of Odanacatib in Healthy Male and Postmenopausal Female Participants at Week 4|Blood samples were obtained predose on Day 1 (Baseline) and at various timepoints up to 336 hr postdose on Day 22 (Week 4) to determine the similarity of steady-state Cmax of odanacatib 50 mg administered Qw for 4 weeks in healthy males and postmenopausal females.|Baseline, Week 4 (1, 2, 6, 12, 24, 48, 72, 96, 120, 144, 168, 240, and 336 hours post-dose)|The population of male and postmenopausal female participants who received Qw treatment with Odanacatib 50 mg for 4 weeks and were compliant with the protocol.||nM||95% Confidence Interval|Geometric Mean
811862|NCT01068262|Secondary|Area Under the Curve of Plasma Concentration-time From 0 to 168 Hours (AUC0-168hr) of Odanacatib at Week 4|Blood samples were obtained predose on Day 1 (Baseline) and at various timepoints up to 336 hr postdose on Day 22 (Week 4) to determine the similarity of steady-state AUC0-168 hr of odanacatib 50 mg administered Qw for 4 weeks in healthy males and postmenopausal females. Characterization of AUC0-168hr after administration of the final, Qw dose of Odanacatib 50 mg at steady state is reflective of the clinical dosing interval.|Baseline, Week 4 (1, 2, 6, 12, 24, 48, 72, 96, 120, 144, 168, 240, and 336 hours post-dose)|The population of male and postmenopausal female participants who received Qw treatment with Odanacatib 50 mg for 4 weeks and were compliant with the protocol.||µM·hr||95% Confidence Interval|Geometric Mean
811863|NCT01068262|Primary|Weighted Average Inhibition (WAI) of Urine Aminoterminal Crosslinked Telopeptide of Type I Collagen (u-NTx/Cr) After Administration of Odanacatib 50 mg or Placebo Qw for 4 Weeks in Healthy Males and Postmenopausal Females|uNTx/Cr is a biomarker of bone resorption. Urine samples were obtained predose on Day 1 (Baseline) and at various timepoints up to 336 hr postdose on Day 22 (Week 4). Fold change from baseline in time weighted average (TWA) of uNTx/Cr on log scale was analyzed via a linear mixed effect model. All analyses were carried out on the log-fold scale and final results were reported on the original percent scale in WAI after back transformation. The conversion used was weighted average inhibition (WAI) = (1-exp [mean])*100, where the mean was the least squares (LS) mean of log-transformed ratio (TWA/baseline) from the above model.|Baseline to Week 4|The population of male and postmenopausal female participants on Qw treatment with Odanacatib 50 mg for 4 weeks and were compliant with the protocol. The population of male participants on placebo are also included. Postmenopausal females on placebo were not analyzed for WAI due to there being too few participants in this group (N=2).||Percent inhibition||90% Confidence Interval|Least Squares Mean
811864|NCT01068418|Secondary|The Change in Renal Blood Flow in Response to an Infusion of Angiotensin II||baseline and 1 month following vitamin D3 therapy|||mL/min/1.72m2||Standard Deviation|Mean
811865|NCT01068418|Primary|The Change in the Mean Arterial Blood Pressure in Response to an Infusion of Angiotensin II||baseline and 1 month following vitamin D3 therapy|||mmHg||Standard Deviation|Mean
811866|NCT01068509|Secondary|Change From Baseline in ICS of IL2, IL4, IL17, TNF, and IFNg in CD4+ and CD8+ Cells at Weeks 20, 56, and 104|Intracellular cytokine staining (ICS) for IL2, IL4, IL17, tumor necrosis factor (TNF), and interferon gamma (IFNg) was done in both CD4+ and CD8+ cells from serum samples collected at Weeks, 20, 56, and 104. Intracellular cytokine staining data were acquired with 8-color flow cytometry on a BD LSR II flow cytometer and a high-throughput screening microplate reader.|Baseline to Week 104|Intent-to-treat population: All randomized participants. Efficacy data were not collected on the initial cohort of 7 non-randomized participants.||Arbitrary units||Standard Deviation|Mean
811867|NCT01068509|Secondary|Change From Baseline in Mucin 1 Antibody Levels at Weeks 20, 56, and 104|Mucin 1 antibodies were assessed in serum samples using a quantitative enzyme-linked immunosorbent assay (ELISA). Detection was achieved with electrochemiluminescence.|Baseline to Week 104|Intent-to-treat population: All randomized participants. Efficacy data were not collected on the initial cohort of 7 non-randomized participants.||Arbitrary units||Standard Deviation|Mean
811868|NCT01068509|Secondary|Overall Survival|Overall survival was defined as the time from randomization until death from any cause.|Baseline to the end of the study (up to 4 years 10 months)|Intent-to-treat population: All randomized participants. Efficacy data were not collected on the initial cohort of 7 non-randomized participants.||Months||95% Confidence Interval|Median
811869|NCT01068509|Primary|Progression-free Survival|Progression-free survival was defined as the time from randomization to the date of documented disease progression or death from any cause, whichever occurred earlier. Disease progression occurred when a patient met either the Gynecologic Cancer Intergroup (GCIG) cancer-antigen (CA)-125 definition or the Response Evaluation Criteria in Solid Tumors (RECIST) radiological definition of progressive disease. The GCIG CA-125 definition of disease progression was defined as a CA-125 level ≥ 2 × the upper limit of normal documented on 2 occasions at least 1 week apart. The radiological RECIST criteria of disease progression was defined as the appearance of new lesions or an overall increase ≥ 20% or at least 5 mm in existing tumors.|Baseline to 48 weeks after the last visit or dose of Cvac (up to 104 weeks)|Intent-to-treat population: All randomized participants. Efficacy data were not collected on the initial cohort of 7 non-randomized participants.||Months||95% Confidence Interval|Median
811870|NCT01068548|Secondary|Time to Change to Oral Antibiotics||1 month||||||
811871|NCT01068548|Primary|Length of Hospital Stay||1 month|||Days||Standard Deviation|Mean
811872|NCT01068600|Secondary|Transition Dyspnoea Index (TDI) Focal Score After 12 Weeks of Treatment|TDI focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort. Each domain is scored from -3 (major deterioration) to 3 (major improvement) to give an overall TDI focal score of -9 to 9 with a negative score indicating a deterioration from baseline. A 1 unit difference in the TDI focal score is clinically significant. Mixed model used baseline dyspnoea index, FEV1 prior to and 10-15 minutes post inhalation of albuterol, and FEV1 prior to and 50-70 minutes post inhalation of ipratropium as covariates.|after 12 weeks|Full Analysis Set included all randomized participants who received at least one dose of study medication. If data were missing or insufficient for any one of the domains a focal score was not calculated. Missing focal scores after week 4 were imputed using last observation carried forward.||Score on a scale||Standard Error|Least Squares Mean
811873|NCT01068600|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) After 12 Weeks of Treatment|Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 hour 10 minute and 23 hour 45 minute post-dose FEV1 readings. Mixed model used baseline FEV1, FEV1 prior to and 10-15 minutes post inhalation of albuterol, and FEV1 prior to and 50-70 minutes post inhalation of ipratropium as covariates.|after 12 weeks|Full Analysis Set included all randomized participants who received at least one dose of study drug. The endpoint was analyzed only for those participants who had data for this outcome measure. Missing data was imputed using last observation carried forward.||Liters||Standard Error|Least Squares Mean
811874|NCT01068626|Secondary|Change in LDL||6 months|||mmol/L||Standard Deviation|Mean
811875|NCT01068626|Secondary|Change in Body Weight||6 months|||kg||Standard Deviation|Mean
811876|NCT01068626|Secondary|Change in Hepatic Fat Infiltration Measured by CT.||6 months|||Hounsfield units||Standard Deviation|Mean
811877|NCT01068626|Secondary|Change in the Ratio Between Intra-abdominal and Subcutaneous Tissue Area Measured by CT.||6 months|||ratio||Standard Deviation|Mean
811878|NCT01068626|Secondary|Change in Subcutaneous Adipose Tissue Area||6 months|||cm2||Standard Deviation|Mean
811879|NCT01068626|Primary|Change in Visceral Adipose Tissue Area Measured by Computed Tomography.||6 months|Per protocol||cm2||Standard Deviation|Mean
811880|NCT01068652|Secondary|Mean of 8-point Plasma Glucose (PG) Profile After 50 Weeks of Treatment|Observed overall mean of 8-point PG profile after 50 weeks of treatment (visit 32)|Week 50|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF).||mg/dL||Standard Deviation|Mean
811881|NCT01068652|Secondary|Mean of 8-point Plasma Glucose (PG) Profile After 38 Weeks of Treatment|Observed overall mean of 8-point PG profile after 38 weeks of treatment (visit 25)|Week 38|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF).||mg/dL||Standard Deviation|Mean
811882|NCT01068652|Secondary|Mean of 8-point Plasma Glucose (PG) Profile After 26 Weeks of Treatment|Observed overall mean of 8-point PG profile after 26 weeks of treatment (visit 18)|Week 26|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF).||mg/dL||Standard Deviation|Mean
811883|NCT01068652|Secondary|Mean of 8-point Plasma Glucose (PG) Profile After 14 Weeks of Treatment|Observed overall mean of 8-point PG profile after 14 weeks of treatment (visit 11)|Week 14|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF).||mg/dL||Standard Deviation|Mean
811884|NCT01068652|Secondary|Mean of Prandial Plasma Glucose (PG) Increment After 50 Weeks of Treatment|Observed overall mean of PG increment after 50 weeks of treatment (visit 32). Mean PG Increment was calculated using the average of difference between the Post Prandial and Pre Prandial Glucose values {ie .average of (Post Breakfast – Pre Breakfast), (Post Lunch – Pre Lunch) and (Post Dinner - Pre Dinner)}.|Week 50|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). For 19 subjects, PG (mg/dL) increment values were missing at all evaluations.||mg/dL||Standard Deviation|Mean
811885|NCT01068652|Secondary|Mean of Prandial Plasma Glucose (PG) Increment After 38 Weeks of Treatment|Observed overall mean of PG increment after 38 weeks of treatment (visit 25). Mean PG Increment was calculated using the average of difference between the Post Prandial and Pre Prandial Glucose values {ie .average of (Post Breakfast – Pre Breakfast), (Post Lunch – Pre Lunch) and (Post Dinner - Pre Dinner)}.|Week 38|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). For 19 subjects, PG (mg/dL) increment values were missing at all evaluations.||mg/dL||Standard Deviation|Mean
811886|NCT01068652|Secondary|Mean of Prandial Plasma Glucose (PG) Increment After 26 Weeks of Treatment|Observed overall mean of PG increment after 26 weeks of treatment (visit 18). Mean PG Increment was calculated using the average of difference between the Post Prandial and Pre Prandial Glucose values {ie .average of (Post Breakfast – Pre Breakfast), (Post Lunch – Pre Lunch) and (Post Dinner - Pre Dinner)}|Week 26|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). For 19 subjects, PG (mg/dL) increment values were missing at all evaluations.||mg/dL||Standard Deviation|Mean
811887|NCT01068652|Secondary|Mean of Prandial Plasma Glucose (PG) Increment After 14 Weeks of Treatment|Observed overall mean of PG increment after 14 weeks of treatment (Visit 11). Mean PG Increment was calculated using the average of difference between the Post Prandial and Pre Prandial Glucose values {ie .average of (Post Breakfast – Pre Breakfast), (Post Lunch – Pre Lunch) and (Post Dinner - Pre Dinner)}|Week 14|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). For 28 subjects, PG (mg/dL) increment values were missing at all evaluations.||mg/dL||Standard Deviation|Mean
811888|NCT01068652|Secondary|Number of Subjects Achieving Glycosylated Haemoglobin (HbA1c) Below 7.0% After 50 Weeks of Treatment|Number of subjects achieving HbA1c below 7.0% after 50 weeks of treatment (visit 32)|Week 50|Full Analysis Set (FAS) includes all randomised subjects. For 35 subjects, values were missing.||Subjects|||Number
811889|NCT01068652|Secondary|Number of Subjects Achieving Glycosylated Haemoglobin (HbA1c) Below 7.0% After 38 Weeks of Treatment|Number of subjects achieving HbA1c below 7.0% after 38 weeks of treatment (visit 25)|Week 38|Full Analysis Set (FAS) includes all randomised subjects. For 31 subjects, values were missing.||Subjects|||Number
811890|NCT01068652|Secondary|Number of Subjects Achieving Glycosylated Haemoglobin (HbA1c) Below 7.0% After 26 Weeks of Treatment|Number of subjects achieving HbA1c below 7.0% after 26 weeks of treatment (visit 18)|Week 26|Full Analysis Set (FAS) includes all randomised subjects. For 29 subjects, values were missing.||Subjects|||Number
811891|NCT01068652|Secondary|Number of Subjects Achieving Glycosylated Haemoglobin (HbA1c) Below 7.0% After 14 Weeks of Treatment|Number of subjects achieving HbA1c below 7.0% after 14 weeks of treatment (visit 11)|Week 14|Full Analysis Set (FAS) includes all randomised subjects. For 20 subjects, values were missing.||Subjects|||Number
811892|NCT01068652|Secondary|Change in Glycosylated Haemoglobin (HbA1c) at Week 50|Observed mean change from baseline in HbA1c at Week 50 (visit 32)|Week 0, Week 50|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). For 20 subjects, values for change in HbA1c were missing.||percentage of glycosylated haemoglobin||Standard Deviation|Mean
811893|NCT01068652|Secondary|Change in Glycosylated Haemoglobin (HbA1c) After 38 Weeks of Treatment|Observed mean change from baseline in HbA1c at Week 38 (visit 25)|Week 0, Week 38|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). For 20 subjects, values for change in HbA1c were missing.||percentage of glycosylated haemoglobin||Standard Deviation|Mean
811894|NCT01068652|Secondary|Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment|Observed mean change in from baseline in HbA1c at Week 26 (visit 18)|Week 0, Week 26|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). For 20 subjects, values for change in HbA1c were missing.||percentage of glycosylated haemoglobin||Standard Deviation|Mean
811895|NCT01068652|Secondary|Change in Glycosylated Haemoglobin (HbA1c) After 14 Weeks of Treatment|Observed mean change from baseline in HbA1c at Week 14 (visit 11)|Week 0, Week 14|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). For 20 subjects, values for change in HbA1c were missing.||percentage of glycosylated haemoglobin||Standard Deviation|Mean
811896|NCT01068652|Primary|Glycosylated Haemoglobin (HbA1c)|Estimated mean difference in HbA1c after 50 weeks of treatment|Week 50|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). For 20 subjects, HbA1c values were missing.||percentage of glycosylated haemoglobin||Standard Error|Mean
811897|NCT01068665|Secondary|Change in Fasting Plasma Glucose (FPG)|Change from baseline in FPG after 26 weeks of treatment|Week 0, Week 26|The FAS included all randomised subjects and missing data was imputed using last observation carried forward (LOCF). For 3 subjects baseline values were missing.||mmol/L||Standard Deviation|Mean
811898|NCT01068665|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Change from baseline in HbA1c after 26 weeks of treatment|Week 0, Week 26|Full analysis set (FAS) includes all randomised subjects and missing data was imputed using last observation carried forward (LOCF). 2 subjects were withdrawn prior to exposure to the study drug in the IDeg arm as they were randomised in error and 1 subject in the IGlar arm.||percentage of glycosylated haemoglobin||Standard Deviation|Mean
811899|NCT01068678|Secondary|Change in Body Weight|Change from baseline in body weight after week 26|Week 26|The Safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or its comparator. Missing data is imputed using last observation carried forward (LOCF). For 3 subjects baseline values were missing.||kg||Standard Deviation|Mean
811900|NCT01068678|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Change from baseline in HbA1c after week 26|Week 26|The Full analysis set (FAS) included all randomised subjects and missing data is imputed using last observation carried forward (LOCF).1 subject was randomised despite being a screening failure.||percentage of glycosylated haemoglobin||Standard Deviation|Mean
811901|NCT01068717|Primary|Time to Achieve the Observed Maximum Plasma Concentration (Tmax) for Saxagliptin and Metformin, Tablets and FDC, Administered to Participants in the Fasted and Fed States||Days 1, 2, and 3 of Periods 1, 2, 3, and 4|All participants who received at least 1 of the 4 treatments and had sufficient plasma concentration data to facilitate the calculation of at least 1 primary pharmacokinetic parameter for at least 1 of the treatments.||Hours||Full Range|Median
811902|NCT01068717|Primary|AUC[0-inf] for Metformin, Tablets and FDC, Administered in the Fasted and Fed States||Days 1, 2, and 3 of Periods 1, 2, 3, and 4|All participants who received at least 1 of the 4 treatments and had sufficient plasma concentration data to facilitate the calculation of at least 1 primary pharmacokinetic parameter for at least 1 of the treatments.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
811903|NCT01068717|Primary|AUC From Time 0 Extrapolated to Infinity (AUC[0-inf]) for Saxagliptin, Tablets and FDC, Given in the Fasted and Fed States||Days 1, 2, and 3 of Periods 1, 2, 3, and 4|All participants who received at least 1 of the 4 treatments and had sufficient plasma concentration data to facilitate the calculation of at least 1 primary pharmacokinetic parameter for at least 1 of the treatments.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
811904|NCT01068717|Primary|AUC[0-t] for Metformin, Tablets and FDC, Given in the Fasted and Fed States||Days 1, 2, and 3 of Periods 1, 2, 3, and 4|All participants who received at least 1 of the 4 treatments and had sufficient plasma concentration data to facilitate the calculation of at least 1 primary pharmacokinetic parameter for at least 1 of the treatments.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
811905|NCT01068717|Secondary|Number of Participants With Clinically Significant Abnormalities in Body Temperature, Blood Pressure, or Heart Rate|Clinically significant was determined by the investigator. Blood pressure and heart rate were measured after the participant had been seated quietly for at least 5 minutes.|At screening visit, prior to dosing on Day 1 of Periods 1 through 4, and at study discharge.|All enrolled participants who received study medication.||Participants|||Number
811906|NCT01068717|Secondary|Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Results|Clinically significant was determined by the investigator. ECGs were recorded after participants had been supine for at least 5 minutes.|At screening visit, Day -1 of Period 1, and at study discharge|All enrolled participants who received study medication.||Participants|||Number
811907|NCT01068717|Secondary|Number of Participants With Clinically Significant Abnormalities in Hematology, Serum Chemistry, and Urinalysis Laboratory Test Results|Clinically significant was determined by the investigator. Hematology tests included hemoglobin, hematocrit, red blood cell count, total leukocyte count (including differential), and platelet count. Serum chemistry tests included aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, lactate dehydrogenase, creatinine, blood urea nitrogen, uric acid, fasting glucose, total protein, albumin, sodium, potassium, chloride, calcium, phosphorus, and creatine kinase. Urinalysis included protein, glucose, blood, leukocyte esterase, specific gravity, and pH.|At screening visit, at Day -1 of Periods 1 through 4, and at discharge|All enrolled participants who received study medication.||Participants|||Number
811933|NCT01068743|Secondary|5-hydroxy Saxagliptin PK Parameter Time to Achieve the Observed Maximum Plasma Concentration (Tmax)|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Tmax is the time taken to reach the maximum observed plasma concentration.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants not discontinuing prior to the end of the study.||hr||Standard Deviation|Mean
811908|NCT01068717|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events, and Adverse Events (AEs) Leading to Discontinuation|An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|Continuously over Days 1 to 3 of treatment Periods 1, 2, 3, and 4|All enrolled participants who received study medication.||Participants|||Number
811909|NCT01068717|Primary|Area Under the Plasma Concentration-time Curve From Time 0 to the Last Quantifiable Concentration (AUC[0-t]) for Saxagliptin, Tablets and FDC, Given in the Fasted and Fed States||Days 1, 2, and 3 of Periods 1, 2, 3, and 4|All participants who received at least 1 of the 4 treatments and had sufficient plasma concentration data to facilitate the calculation of at least 1 primary pharmacokinetic parameter for at least 1 of the treatments.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
811910|NCT01068717|Primary|Terminal Half-life (t1/2) of Saxagliptin and Metformin, Tablets and FDC, Administered to Participants in the Fasted and Fed States||Days 1, 2, and 3 of Periods 1, 2, 3, and 4|All participants who received at least 1 of the 4 treatments and had sufficient plasma concentration data to facilitate the calculation of at least 1 primary pharmacokinetic parameter for at least 1 of the treatments.||Hours||Standard Deviation|Mean
811911|NCT01068717|Primary|Observed Cmax of Metformin, Tablets and FDC, Administered to Participants in the Fasted and Fed States||Days 1, 2, and 3 of Periods 1, 2, 3, and 4|All participants who received at least 1 of the 4 treatments and had sufficient plasma concentration data to facilitate the calculation of at least 1 primary pharmacokinetic parameter for at least 1 of the treatments.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
811912|NCT01068717|Primary|Observed Maximum Plasma Concentration (Cmax) of Saxagliptin, Tablets and Fixed-dose Combination (FDC), Administered to Participants in the Fasted and Fed States||Days 1, 2, and 3 of Periods 1, 2, 3, and 4|All participants who received at least 1 of the 4 treatments and had sufficient plasma concentration data to facilitate the calculation of at least 1 primary pharmacokinetic parameter for at least 1 of the treatments.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
811913|NCT01068730|Other Pre-specified|Metformin Pharmacokinetic (PK) Parameter Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-t])|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC[0-t] is the area under the plasma concentration-time curve from time zero to time of last measurable concentration.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants with evaluable PK analyses.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
811914|NCT01068730|Secondary|Participants With Clinical Laboratory Findings Considered Clinically Significant or Reported as an AE: Urinalysis|Clinically significant was determined by the investigator.|From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).|All treated participants not discontinuing prior to the end of the study.||Participants|||Number
811915|NCT01068730|Secondary|Participants With Clinical Laboratory Findings Considered Clinically Significant or Reported as an AE: Serum Chemistry|Clinically significant was determined by the investigator.|From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).|All treated participants not discontinuing prior to the end of the study.||Participants|||Number
811916|NCT01068730|Secondary|Participants With Clinical Laboratory Findings Considered Clinically Significant or Reported as an AE: Hematology|Clinically significant was determined by the investigator.|From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).|All treated participants not discontinuing prior to the end of the study.||Participants|||Number
811917|NCT01068730|Other Pre-specified|Metformin Pharmacokinetic (PK) Parameter Terminal Half-life (T 1/2)|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. T 1/2 is the time required for the concentration of the drug to reach half of its original value in plasma|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants with evaluable PK analyses. In treatment D, T 1/2 was not analysed for 1 participant who did not have a clear terminal elimination phase.||hr||Standard Deviation|Mean
811918|NCT01068730|Other Pre-specified|Metformin Pharmacokinetic (PK) Parameter Time to Achieve the Observed Maximum Plasma Concentration (Tmax)|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Tmax is the time taken to reach the maximum observed plasma concentration.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants with evaluable PK analyses.||hr||Standard Deviation|Mean
811919|NCT01068730|Secondary|Participants With Abnormal Vital Sign Findings Reported as an AE|per investigator|From Day 1/Period 1 to study discharge or premature discontinuation. Duration of study was approximately 45 days (including screening).|All treated participants not discontinuing prior to the end of the study.||Participants|||Number
811920|NCT01068730|Secondary|Participants With Abnormal Physical Findings|Physical findings that were considered abnormal by the investigator.|From Day 1/Period 1 to study discharge or premature discontinuation. Duration of study was approximately 45 days (including screening).|All treated participants not discontinuing prior to the end of the study.||Participants|||Number
811921|NCT01068730|Secondary|Participants With Electrocardiogram Abnormalities Considered Clinically Significant or Reported as an AE|Clinically significant was determined by the investigator. ECGs were recorded after participants had been supine for at least 5 minutes.|From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).|All treated participants not discontinuing prior to the end of the study.||Participants|||Number
811934|NCT01068743|Secondary|5-hydroxy Saxagliptin PK Parameter Terminal Half-life (T 1/2)|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. T 1/2 is the time required for the concentration of the drug to reach half of its original value in plasma.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants not discontinuing prior to the end of the study.||hr||Standard Deviation|Mean
811922|NCT01068730|Secondary|Participants With Adverse Events (AEs), Discontinuations Due to AEs, Deaths, and Serious AEs (SAEs)|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.|AEs: from study drug administration Day 1/Period 1 till study discharge. SAEs: from date of written consent until 30 days after discontinuation of dosing or study participation. Duration of the study was approximately 45 days (including screening).|All treated participants not discontinuing prior to the end of the study.||Participants|||Number
811923|NCT01068730|Primary|Metformin PK Parameter Observed Maximum Plasma Concentration (Cmax)|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Cmax is the maximum observed concentration of drug substance in plasma.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants with evaluable PK analyses.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
811924|NCT01068730|Primary|Metformin Pharmacokinetic (PK) Parameter Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity (AUC[0-inf])|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC (0-inf) is the area under the plasma concentration-time curve from time zero extrapolated to infinite time.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants with evaluable PK analyses. In treatment D, AUC (0-inf) was not analysed for 1 participant who did not have a clear terminal elimination phase.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
811925|NCT01068743|Secondary|Safety: Clinically Significant Laboratory, Vital Sign, Physical Examination, and/or 12-Lead Electrocardiogram (ECG) Abnormalities|Abnormalities that were considered clinically significant and/or reported as an AE by the investigator.|From Day 1/Period 1 to study discharge or premature discontinuation. Duration of study was approximately 45 days (including screening).|All participants who received at least one dose of study medication.||participants|||Number
811926|NCT01068743|Other Pre-specified|Metformin PK Parameter Tmax|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Tmax is the time taken to reach the maximum observed plasma concentration.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants not discontinuing prior to the end of the study.||hr||Standard Deviation|Mean
811927|NCT01068743|Other Pre-specified|Metformin PK Parameter T1/2|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. T 1/2 is the time required for the concentration of the drug to reach half of its original value in plasma.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants not discontinuing prior to the end of the study. One participant in period 3 (treatment D) was excluded from the pharmacokinetic analysis due to a predose concentration greater than 5% of Cmax.||hr||Standard Deviation|Mean
811928|NCT01068743|Other Pre-specified|Metformin PK Parameter AUC(0-t)|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC(0-t) is the area under the plasma concentration-time curve from time zero to time of last measurable concentration.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants not discontinuing prior to the end of the study.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
811929|NCT01068743|Other Pre-specified|Saxagliptin PK Parameter Tmax|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Tmax is the time taken to reach the maximum observed plasma concentration.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants not discontinuing prior to the end of the study. One participant in period 3 (treatment D) was excluded from the pharmacokinetic analysis due to a predose concentration greater than 5% of Cmax.||hr||Standard Deviation|Mean
811930|NCT01068743|Other Pre-specified|Saxagliptin PK Parameter T1/2|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. T 1/2 is the time required for the concentration of the drug to reach half of its original value in plasma.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants not discontinuing prior to the end of the study. One participant in period 3 (treatment D) was excluded from the pharmacokinetic analysis due to a predose concentration greater than 5% of Cmax.||hr||Standard Deviation|Mean
811931|NCT01068743|Other Pre-specified|Saxagliptin PK Parameter AUC(0-t)|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC(0-t) is the area under the plasma concentration-time curve from time zero to time of last measurable concentration.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants not discontinuing prior to the end of the study. One participant in period 3 (treatment D) was excluded from the pharmacokinetic analysis due to a predose concentration greater than 5% of Cmax.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
811932|NCT01068743|Secondary|Safety: Adverse Events (AEs), Discontinuations Due to AEs, Deaths, and Serious AEs (SAEs).|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.|AEs: from study drug administration Day 1/Period 1 till study discharge. SAEs: from date of written consent until 30 days after discontinuation of dosing or study participation. Duration of the study was approximately 45 days (including screening).|All participants who received at least one dose of study medication.||participants|||Number
811964|NCT01069003|Primary|Incidence of Major Bleeding (GUSTO Classification, Severe and Moderate Bleeding Combined) for Randomized Subjects||Placebo and Thienopyridine 12 - 30 months; Surveillance Arm (0 - 24 months)|||Percentage of participants|||Number
824782|NCT01178268|Secondary|Follow-up In-segment Minimum Lumen Diameter (MLD)||≥13 months|The number of participants with angiographic follow up available was analysed.||Millimeter|Participants|Standard Deviation|Mean
811935|NCT01068743|Secondary|5-hydroxy Saxagliptin PK Parameter Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-t])|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC[0-t] is the area under the plasma concentration-time curve from time zero to time of last measurable concentration.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants not discontinuing prior to the end of the study.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
811936|NCT01068743|Primary|Metformin PK Parameter Cmax|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Cmax is the maximum observed concentration of drug substance in plasma.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants not discontinuing prior to the end of the study.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
811937|NCT01068743|Primary|Metformin PK Parameter AUC(0-inf)|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC (0-inf) is the area under the plasma concentration-time curve from time zero extrapolated to infinite time.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants not discontinuing prior to the end of the study. One participant in period 3 (treatment D) was excluded from the pharmacokinetic analysis due to a predose concentration greater than 5% of Cmax.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
811938|NCT01068743|Primary|Saxagliptin PK Parameter Observed Maximum Plasma Concentration (Cmax)|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Cmax is the maximum observed concentration of drug substance in plasma.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants not discontinuing prior to the end of the study. One participant in period 3 (treatment D) was excluded from the pharmacokinetic analysis due to a predose concentration greater than 5% of Cmax.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
811939|NCT01068743|Secondary|5-hydroxy Saxagliptin PK Parameter Cmax|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Cmax is the maximum observed concentration of drug substance in plasma.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants not discontinuing prior to the end of the study.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
811940|NCT01068743|Secondary|5-hydroxy Saxagliptin PK Parameter AUC(0-inf)|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC (0-inf) is the area under the plasma concentration-time curve from time zero extrapolated to infinite time.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants not discontinuing prior to the end of the study.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
811941|NCT01068743|Primary|Saxagliptin Pharmacokinetic (PK) Parameter Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity (AUC[0-inf])|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC (0-inf) is the area under the plasma concentration-time curve from time zero extrapolated to infinite time.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants not discontinuing prior to the end of the study. One participant in period 3 (treatment D) was excluded from the pharmacokinetic analysis due to a predose concentration greater than 5% of Cmax.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
811942|NCT01068769|Secondary|Progression-free Survival (PFS)|Progression-free survival is defined as the duration of time from start of study drug administration to time of objective disease progression or death due to any cause, whichever comes first. Progression is evaluated every 8 weeks using Response Criteria for Solid Tumors (RECIST) 1.1. Objective disease progression is defined as a 20% increase in the sum of the longest diameter of target lesion(s).|From date of enrollment until date of first documented progression or date of death from any cause, whichever came first|||months||95% Confidence Interval|Median
811943|NCT01068769|Primary|Clinical Benefit as Defined by the Composite of Complete Response, Partial Response and Stable Disease Lasting 16 Weeks or More Per RECIST 1.1 as a Measure of Disease Control|The composite of complete response, partial response, and stable disease lasting 16 weeks or more per RECIST 1.1 as a measure of disease control. This is for target lesions. Complete response is disappearance of all target lesions and partial response is >+30% decrease in the sum of the longest diameter of target lesions. Stable disease is neither shrinkage by greater than or equal to 30% of the sum of the longest diameter of target lesions or the increase of lesions by greater than or equal to 20% of the sum of the longest diameter of target lesions. Progressive disease is considered an increase of the sum of the longest diameter of target lesions by greater than or equal to 20%.|2 years|||percentage of participants||95% Confidence Interval|Number
811944|NCT01068821|Secondary|Number of Participants Reporting a Neurologic Deficit in Extremities After Surgery|The neurologic deficit was assessed as follows: Patients' postoperative care was unchanged from routine for this study. Any postoperative complaints regarding limb pain or weakness or numbness were recorded and assessed with neurologic exam to determine sensation or motor components. Absence of resolution was documented.|postoperative day 1 and postoperative week 3-8|Participants were analyzed per protocol if they returned for postoperative followup (59 of 60 were analyzed)||participants|||Number
811945|NCT01068821|Primary|Amount of Patient Movement on the Operating Room Table|Patients undergoing gynecologic surgery require steep (30 to 45 degree) Trendelenberg's position to allow adequate exposure of the pelvis. This position leads to a small amount of movement toward the head of the bed. The table was marked at the point of the anterior superior iliac spine (ASIS) and at the point where a vertical marker touching the acromioclavicular (AC) joint of the left shoulder drops to the table. At the end of the surgery, when the operating table is leveled, the final positions of ASIS and AC will be measured. Measurements were made in centimeters to the tenth position.|About 150 minutes after start of surgery|Study size calculation was performed for 80% power, and p=0.05||centimeters||Standard Deviation|Mean
811979|NCT01069289|Secondary|Morning Forced Expiratory Volume in One Second (FEV1)|The change from Run-in period average to Treatment period average for each treatment group|Daily during run-in period and daily during 12-week randomization treatment|The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.||Liter (L)||Standard Deviation|Mean
811946|NCT01068860|Secondary|Number of Participants Reporting Death, Serious Adverse Events (SAEs) and Adverse Events (AEs) Above 5% Frequency, From Baseline to 4 Weeks|An adverse event is any unwanted event, whether related to study drug or not occuring during the study period. A Serious Adverse Event (SAE) is an event resulting in death, requiring or prolonging hospitalization, a congenital anomaly or other important medical event. AEs and SAEs were recorded at each visit.|Baseline, 4 weeks|Safety Population consisted of all participants who received at least one dose of study medication and had at least one post-baseline safety assessment.||participants|||Number
811947|NCT01068860|Secondary|Mean Change in Peak Plasma C-peptide Level, From Baseline to 4 Weeks|"Change in mean peak plasma C-peptide level measured from Baseline to 4 weeks of treatment.
A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population."|Baseline, 4 weeks|Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.||nmol/L||Standard Error|Least Squares Mean
811948|NCT01068860|Secondary|Mean Change in Peak Plasma Insulin, From Baseline to 4 Weeks|Change in mean peak plasma Insulin level as measured from Baseline to 4 weeks of treatment. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population.|Baseline, 4 weeks|Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.||pmol/L||Standard Error|Least Squares Mean
811949|NCT01068860|Secondary|Mean Change in Peak Plasma Glucose, From Baseline to 4 Weeks|"Change in peak plasma glucose level as measured from Baseline to 4 weeks of treatment.
A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population."|Baseline, 4 weeks|Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.||mmol/L||Standard Error|Least Squares Mean
811950|NCT01068860|Secondary|Mean Change in Post-prandial Glucose Area Under the Curve (AUC)0-4 Hours, From Baseline to 4 Weeks|Blood samples were drawn after a test meal at 0, 15, 30, 45, 60, 90, 120, 180 and 240 min. Insulin levels over 4 hrs were shown as Area Under the Curve,(AUC). AUC was calculated as: x=1 AUC ΣAx n Where Ax = AUC for the 240 min.interval, and X = 1 for the 1st interval. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab vs placebo within each T2DM group. The mixed model didn't include the IGT group.|Baseline, 4 weeks|Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.||mmol*hr/L||Standard Error|Least Squares Mean
811951|NCT01068860|Secondary|Mean Change in C-peptide Area Under the Curve (AUC), 0-4 Hours, From Baseline to 4 Weeks|Blood samples were drawn after a test meal at 0, 15, 30, 45, 60, 90, 120, 180 and 240 min. Insulin levels over 4 hrs were shown as Area Under the Curve,(AUC). AUC was calculated as: x=1 AUC ΣAx n Where Ax = AUC for the 240 min.interval, and X = 1 for the 1st interval. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab vs placebo within each T2DM group. The mixed model didn't include the IGT group.|Baseline, 4 weeks|Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.||nmol*hour/L||Standard Error|Least Squares Mean
811952|NCT01068860|Secondary|Mean Change in Insulin Area Under the Curve (AUC) 0-4 Hours, From Baseline to 4 Weeks|Blood samples were drawn after a test meal at 0, 15, 30, 45, 60, 90, 120, 180 and 240 min. Insulin levels over 4 hrs were shown as Area Under the Curve,(AUC). AUC was calculated as: x=1 AUC ΣAx n Where Ax = AUC for the 240 min.interval, and X = 1 for the 1st interval. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab vs placebo within each T2DM group. The mixed model didn't include the IGT group.|Baseline, 4 weeks|Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.||pmol*hour/L||Standard Error|Least Squares Mean
811953|NCT01068860|Secondary|Mean Change in Absolute Glucose Level at 2 Hours, From Baseline to 4 Weeks|"Change in glucose level measured after 2 hours of fasting. Blood sample was drawn at 0 minutes and at 240 minutes.
A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population."|Baseline, 4 weeks|Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.||mmol/L||Standard Error|Least Squares Mean
811954|NCT01068860|Secondary|Mean Change in Fasting Glucose Disposition Index(GDI)1 and Index 2, From Baseline to 4 Weeks|GDI 1 is the product of insulin sensitivity index (Si)during the 1st phase of insulin secretion and β-cell function as measured by the acute insulin response (AIR).GDI 2 is the product of (Si)during the 2nd phase of insulin secretion and β-cell function as measured by the acute insulin response (AIR). A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT group.|Baseline, 4 weeks|Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.||number||Standard Error|Least Squares Mean
811980|NCT01069289|Secondary|Total Number of Day With Exacerbation|Total number of days with COPD exacerbation for each treatment group|Daily during 12-week randomization treatment|The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.||days|||Number
813408|NCT01078584|Other Pre-specified|Number of Participants Adding Concomitant Cardiovascular Medications at 3 Months|Presented by type of medication added.|3 Months|Evaluable participants (all participants in the ITT cohort with available data at given time point).||participants|||Number
811955|NCT01068860|Secondary|Mean Change in Quantitative Insulin Sensitivity Check Index (QUICKI) Score, From Baseline to 4 Weeks|"The Quantitative Insulin Sensitivity Check Index (QUICKI) score, measures insulin sensitivity which is the inverse of insulin resistance. The score is calculated by the equation: 1 /(log(fasting insulin µU/mL) + log(fasting glucose mg/dL)). In normal subjects the mean score ± SE is 0.366 ± 0.029.
A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population."|Baseline, 4 weeks|Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.||number||Standard Error|Least Squares Mean
811956|NCT01068860|Secondary|Mean Change in Fasting Plasma Insulin, From Baseline to 4 Weeks|"Change in Fasting Insulin level taken from plasma, measured at Baseline and after 4 weeks of treatment.
A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population"|Baseline, 4 weeks|Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.||pmol/L||Standard Error|Least Squares Mean
811957|NCT01068860|Secondary|Mean Change in Fructosamine, From Baseline to 4 Weeks|"Change in Fructosamine Level taken from plasma, measured at Baseline and after 4 weeks of treatment.
A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population"|Baseline, 4 weeks|Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.||mmol/L||Standard Error|Least Squares Mean
811958|NCT01068860|Secondary|Mean Change in Fasting Plasma Glucose, From Baseline to 4 Weeks|"Change in Fasting Glucose Level measured from plasma taken at Baseline and after 4 weeks of treatment.
A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population"|Baseline, 4 weeks|Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.||mmol/L||Standard Error|Least Squares Mean
811959|NCT01068860|Secondary|Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 0-4 Hours, From Baseline to 4 Weeks.|Change in Insulin Secretion Rate stimulated by Liquid mixed-meal challenge. Blood samples were taken prior to and after meal for glucose, insulin and C-peptide at sample times: -20, -10, -1 and 10, 20, 30, 60, 90, 120, 180, and 240 minutes relative to the start of the meal. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population.|Baseline, 4 weeks|Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.||pmol/min/m^2/mmol/L||Standard Error|Least Squares Mean
811960|NCT01068860|Secondary|Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 2-4 Hours, From Baseline to 4 Weeks|Change in Insulin Secretion Rate stimulated by Liquid mixed-meal challenge Blood samples were taken prior to and after meal for glucose and insulin at sample times: -20, -10, -1 and 10, 20, 30, 60, 90, 120, 180, and 240 minutes relative to the start of the meal. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population|Baseline, 4 weeks|Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.||pmol/min/m^2/mmol/L||Standard Error|Least Squares Mean
811961|NCT01068860|Primary|Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 0-2 Hours, From Baseline to 4 Weeks.|Change in Insulin Secretion Rate stimulated by Liquid mixed-meal challenge. Blood samples were taken prior to and after meal for glucose and insulin at sample times: -20, -10, -1 and 10, 20, 30, 60, 90, 120, 180, and 240 minutes relative to the start of the meal.A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include patients from the IGT population|Baseline, 4 weeks|Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.||pmol/min/m^2/mmol/L||Standard Error|Least Squares Mean
811962|NCT01068912|Primary|Clinical Efficacy of 2 Dose Regimens of Favipiravir Compared With Placebo in Treating Patients With Influenza|"Overall time required from first study drug administration to alleviation of the 6 primary influenza symptoms and for temperature (oral) measurements to be less than 38.0°C for patients aged 20 to less than 65 years and less than 37.8°C for patients aged 65 years or older. Alleviated was defined as all 6 symptom scores had to be decreased to 1 or below and the decrease remain unchanged for 21.5 hours."|22 weeks|The primary analysis population for efficacy analyses was the ITTI Population (N=333), defined as all patients who received at least 1 dose of study drug with any available efficacy data after randomization and who tested positive for influenza A or B by PCR assay or culture tests on Day 1 using determinations.||hours||95% Confidence Interval|Median
811963|NCT01068964|Primary|The Difference of Change From Baseline of Mean Diurnal Intraocular Pressure (IOP) Between the Two Treatment Groups at Week 4|The difference of change from baseline of mean diurnal IOP between the 0.03% Bimatoprost/0.5% Timolol in Same Bottle and the 0.03% Bimatoprost and 0.5% Timolol in Separate Bottles at week 4. IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the average of the IOP values of the study eye (the eye with the highest IOP at baseline) over the 3 time points measured at 8AM, 12PM and 4PM. A negative number change from baseline indicated a reduction (improvement) in IOP. The difference of change from baseline in IOP is presented in the statistical analysis section.|Baseline, Week 4|Intent to Treatment population defined as all patients randomized. One patient in the 0.03% Bimatoprost/0.5% Timolol in Same Bottle group was not included in the analysis.||Millimeters of mercury (mmHg)||Standard Deviation|Mean
811965|NCT01069003|Primary|Percentage of Participants of Incidence of ARC Definite or Probable Stent Thrombosis (ST) for Randomized Subjects|"All definite and probable Stent Thrombosis (ST) are adjudicated by an independent committee according to the definition based on Academic Research Consortium (ARC)
Definite is defined as angiographic or pathologic confirmation of partial or total thrombotic occlusion within the peri-stent region and at least 1 of the following: Acute ischemic symptoms, Ischemic ECG changes, Elevated cardiac biomarkers
Probable defined as any unexplained death within the first 30 days of procedure and any myocardial infarction, which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause"|Placebo and Thienopyridine 12 - 30 months; Surveillance Arm (0 - 24 months)|||percentage of participants|||Number
811966|NCT01069003|Primary|Percentage of Participants With Composite of All Death, Target Vessel Myocardial Infarction (MI) and Stroke (Defined as MACCE) for Randomized Subjects||Placebo and Thienopyridine 12 - 30 months; Surveillance Arm (0 - 24 months)|||Percentage of participants|||Number
811967|NCT01069120|Primary|To Assess the Incidence of Adverse Events (AE) and Serious Adverse Events (SAEs)||During two 4 month treatment periods||||||
811968|NCT01069172|Secondary|Cumulative Dissipated Energy (CDE)|"CDE (the amount of ultrasound energy delivered during phacoemulsification of the crystalline lens) used will be measured during surgery. CDE is a unit used for the Alcon Infinity System (the U/S phacoemulsification used in this study). It is not expressed in standard units such as watts or Joules. CDE, which accounts for the power and time of two ultrasound delivery modes (longitudinal and torsional), is calculated as follows:
CDE = (Phaco time x average phaco power) + (torsional time x average torsional aptitude x 0.4)
0.4 is a factor representing the approximate reduction of heat dissipated at the incision as compared to conventional phacoemulsification."|Day of Surgery|29 subjects had FS laser surgery in one eye (29 FS surgery eyes) and CCC with U/S surgery in their fellow eye (29 CCC surgery eyes). Analysis of CDE was done by eye group.||CDE||Standard Deviation|Mean
811969|NCT01069172|Primary|Deviation From Intended Capsulotomy Diameter|Capsulotomy diameter measured during surgery for both the experimental and control groups.|Day of Surgery|29 subjects had FS laser surgery in one eye (29 FS surgery eyes) and CCC with U/S surgery in their fellow eye (29 CCC surgery eyes). Analysis of capsulotomy size was done by eye group.||μm||Standard Deviation|Mean
811970|NCT01069185|Secondary|Mechanical Ventilation Length as Days.|Number of days under mechanical ventilation during ICU hospitalization length|Every day while patient really is intubated.|||Days||Inter-Quartile Range|Median
811971|NCT01069185|Primary|Primary Composite End Point|All causes of morbidity. Clinically identified as hypoxaemia, unplanned extubation, cardiac arrythmias, cardiac arrest. Measured as any change in patient´s monitor identified for ancillary nurse and/or confirmed directly by pediatrician.|Every component for primary outcome can be assessed during or after suctioning is applied.For routine protocol, every 2 hours for necessity protocol will depend on patient´s necessity. The assessment was done in each patient during intubation period .|||event|suctioning||Number
811972|NCT01069289|Secondary|St George’s Respiratory Questionnaire (SGRQ) Total Score|The change from Run-in period average to Treatment period average for each treatment group. The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life).|Daily during run-in period and daily during 12-week randomization treatment|The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.||units on a scale||Standard Deviation|Mean
811973|NCT01069289|Secondary|Use of Rescue Medication|The change from Run-in period average to Treatment period average for each treatment group.|Daily during run-in period and daily during 12-week randomization treatment|The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.||inhalations/day||Standard Deviation|Mean
811974|NCT01069289|Secondary|Total Chronic Obstructive Pulmonary Disease (COPD) Symptom Score|The Total COPD Symptom score is the sum of the measures night-time awakening, breathlessness and cough, ranges from 0 to 12 with 12 being the most severe. The change from Run-in period average to Treatment period average for each treatment group.|Daily during run-in period and daily during 12-week randomization treatment|The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.||units on a scale||Standard Deviation|Mean
811975|NCT01069289|Secondary|Cough Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms|There are 5 alternatives (scored 0 to 4, with 4 being the most severe condition). The change from Run-in period average to Treatment period average for each treatment group|Daily during run-in period and daily during 12-week randomization treatment|The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.||units on a scale||Standard Deviation|Mean
811976|NCT01069289|Secondary|Breathlessness Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms|There are 5 alternatives (scored 0 to 4, with 4 being the most severe condition). The change from Run-in period average to Treatment period average for each treatment group|Daily during run-in period and daily during 12-week randomization treatment|The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.||units on a scale||Standard Deviation|Mean
811977|NCT01069289|Secondary|Night-time Awakening Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms|Scored 0 to 1 (0 = no awakening and 1 = awakening). The change from Run-in period average to Treatment period average for each treatment group|Daily during run-in period and daily during 12-week randomization treatment|The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.||Nights with symptoms||Standard Deviation|Mean
811978|NCT01069289|Secondary|Evening Forced Expiratory Volume in One Second (FEV1)|The change from Run-in period average to Treatment period average for each treatment group|Daily during run-in period and daily during 12-week randomization treatment|The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.||Liter (L)||Standard Deviation|Mean
811981|NCT01069289|Secondary|Evening Peak Expiratory Flow (PEF)|The change from Run-in period average to Treatment period average for each treatment group|Daily during run-in period and daily during 12-week randomization treatment|The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.||Liter/minute (L/min)||Standard Deviation|Mean
811982|NCT01069289|Secondary|Morning Peak Expiratory Flow(PEF)|The change from Run-in period average to Treatment period average for each treatment group|Daily during run-in period and daily during 12-week randomization treatment|The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.||Liter/minute (L/min)||Standard Deviation|Mean
811983|NCT01069289|Secondary|Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation|A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as worsening in COPD symptoms requiring treatment with either a course of systemic steroid or hospitalisation. Number of COPD exacerbation during 12-week randomization treatment|Daily during 12-week randomization treatment|The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.||event|||Number
811984|NCT01069289|Secondary|Percentage of Participants With Exacerbations|A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as worsening in COPD symptoms requiring treatment with either a course of systemic steroid or hospitalisation. The percentage of participants who had experienced COPD exacerbation at the end of the study for each treatment group.|Daily during 12-week randomization treatment|The analysis set for efficacy was based on the Full Analysis Set (FAS).Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.||percentage of participants|||Number
811985|NCT01069289|Secondary|1 Hour Post-dose Forced Vital Capacity (FVC)|The ratio, expressed as percentage, of the geometric mean of available data for Weeks 0, 4, 8 and 12 to the baseline for each treatment group|Before randomization, 0, 4, 8 and 12 weeks after randomization|The analysis set for efficacy was based on the Full Analysis Set (FAS. Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.||percentage of Baseline||Full Range|Geometric Mean
811986|NCT01069289|Secondary|Pre-dose Forced Vital Capacity (FVC)|The ratio, expressed as percentage, of the geometric mean of available data for Weeks 0, 4, 8 and 12 to the baseline for each treatment group|Before randomization, 0, 4, 8 and 12 weeks after randomization|The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.||percentage of Baseline||Full Range|Geometric Mean
811987|NCT01069289|Secondary|1 Hour Post Dose Forced Expiratory Volume in One Second (FEV1)|The ratio, expressed as percentage, of the geometric mean of available data for Weeks 0, 4, 8 and 12 to the baseline for each treatment group|Before randomization, 0, 4, 8 and 12 weeks after randomization|The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.||percentage of Baseline||Full Range|Geometric Mean
811988|NCT01069289|Primary|Pre-dose Forced Expiratory Volume in One Second (FEV1)|The ratio, expressed as percentage, of the geometric mean of available data for Weeks 0, 4, 8 and 12 to the baseline for each treatment group|Before randomization, 0, 4, 8 and 12 weeks after randomization|The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.||percentage of Baseline||Full Range|Geometric Mean
811989|NCT01069341|Secondary|Mean Change in Intraocular Pressure (IOP)|Mean change in IOP (mm Hg) from baseline to months-3, 7, and 12.|at months-3,7, and 12|All subjects' data was analyzed, no subjects were excluded||mmHg||Standard Deviation|Mean
811990|NCT01069341|Secondary|Mean Number of PRP Laser Treatments|Mean number of PRP laser treatments required through month 12|first 12 months|All subjects' data was analyzed, no subjects were excluded||PRP Laser treatments||Standard Deviation|Mean
811991|NCT01069341|Secondary|Mean Number of Ranibizumab Injections|Mean number of ranibizumab injections required through month 12|first 12 months|All subjects' data was analyzed, no subjects were excluded||Number injections||Standard Deviation|Mean
811992|NCT01069341|Secondary|Mean Time to Re-treatment|Mean time to re-treatment following the initial three monthly loading doses of ranibizumab (months)|first 12 months|All subjects' data was included||months||Standard Deviation|Mean
811993|NCT01069341|Secondary|Macular Volume|Macular volume (millimeters cubed [mm3]) by Stratus OCT|at months-1,3,7, and 12|All subjects' data was analyzed, no subjects were excluded||Macular volume (millimeters cubed)||Standard Deviation|Mean
811994|NCT01069341|Secondary|Presence of Proliferative Diabetic Retinopathy (PDR)|Presence of proliferative diabetic retinopathy by fluorescein angiogram|at month-12|All subjects' data was analyzed, no subjects were excluded||participants|||Number
811995|NCT01069341|Secondary|Presence of Neovascularization of Iris (NVI) or Neovascularization of the Angle (NVA)|Presence of neovascularization of iris (NVI) or neovascularization of the angle (NVA) as assessed by gonioscopy at months 3, 7 and 12|months 3, 7 and 12|All subjects' data was analyzed, no subjects were excluded||participants|||Number
811996|NCT01069341|Primary|Adverse Event (AE)|Incidence and severity of AEs that were cataract surgery related (for instance, hyphema and vitreous hemorrhage) and AEs that occurred during the treatment of proliferative diabetic retinopathy (PDR).|first 12 months|All subjects' data was analyzed, no subjects were excluded||participants|||Number
812009|NCT01069562|Secondary|Percentage of Time Mean Arterial Pressure Remained Within 25% of Pre-op Baseline|The duration of time mean arterial pressure remained within 25% of the pre-operative baseline value during the period isoflurane (general anesthetic) was administered to the study population. This value is expressed as percentage. This outcome is expressed as the mean of percentage of time per participant|8 hours (approximately)|All the patients who were randomized completed the study protocol and were included for analysis||percentage of time||Standard Deviation|Mean
812022|NCT01069627|Secondary|Overall Survival (OS) - Percentage of Participants With an Event|OS was defined as the time from the starting day of the therapy up to death or the last date the participant was known to be alive.|Baseline, every 3 weeks to end-of-treatment, every 3 months during follow-up, to death or end-of-study (maximum of 36 months)|ITT population||percentage of participants|||Number
811997|NCT01069419|Secondary|Change From Baseline to Visit 9 (Around Week 104) in Disease Activity Measured by Clinical Disease Activity Index (CDAI)|"The CDAI was calculated with the equation:
CDAI= Tender Joint Count + Swollen Joint Count + PtGADA/10 + PhGADA/10 where PtGADA (mm) is the Patient’s Global Assessment of Disease Activity using a Visual Analog Scale (VAS) ranging from 0 to 100, and PhGADA (mm) is the Physician’s Global Assessment of Disease Activity using a VAS ranging from 0 to 100. Thus, the CDAI ranges from 0 to 76, with higher values indicating higher disease activity. If any individual term was missing, then the CDAI was set to missing. A negative value in Change from Baseline indicates an improvement from Baseline to Visit 9 (around Week 104)."|From Baseline to Visit 9 (around Week 104)|Full Analysis Set (FAS) using Mixed Model with Repeated Measures imputation (MMRM). FAS is defined as all patients with a DAS28 ≥ 2.6 at baseline who took at least 1 dose of Certolizumab Pegol and had at least 1 valid post-Baseline DAS28 value.||units on a scale||Standard Deviation|Mean
811998|NCT01069419|Secondary|Change From Baseline to Visit 9 (Around Week 104) in Patient's Physical Function as Measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI)|The HAQ-DI contains 20 items on a 4-point scale ranging from 0 (without any difficulty) to 3 (unable to do). The 20 items are grouped in 8 categories with 2 to 3 items each. The category scores are averaged into an overall HAQ-DI from 0 to 3. Scores of 0 to 1 generally represent mild to moderate difficulty, 1 to 2 represent moderate to severe disability, and 2 to 3 indicate severe to very severe disability. A negative value in Change from Baseline indicates an improvement from Baseline to Visit 9 (around Week 104).|From Baseline to Visit 9 (around Week 104)|Full Analysis Set (FAS) using Mixed Model with Repeated Measures imputation (MMRM). FAS is defined as all patients with a DAS28 ≥ 2.6 at baseline who took at least 1 dose of Certolizumab Pegol and had at least 1 valid post-Baseline DAS28 value.||units on a scale||Standard Deviation|Mean
811999|NCT01069419|Secondary|Change From Baseline to Visit 9 (Around Week 104) in Patients's Arthritis Pain as Measured by Patient's Assessment of Arthritis Pain (PAAP) Visual Analog Scale (VAS)|Patients rated how much pain they were experiencing at the time of the visit caused by their Arthritis using a Visual Analog Scale (VAS) ranging from 0 (no pain) to 100 (most severe pain). A negative value in Change from Baseline indicates an improvement from Baseline to Visit 9 (around Week 104).|From Baseline to Visit 9 (around Week 104)|Full Analysis Set (FAS) using Mixed Model with Repeated Measures imputation (MMRM). FAS is defined as all patients with a DAS28 ≥ 2.6 at baseline who took at least 1 dose of Certolizumab Pegol and had at least 1 valid post-Baseline DAS28 value.||units on a scale||Standard Deviation|Mean
812000|NCT01069419|Primary|Clinical Remission at Visit 9 (Around Week 104) Measured by Achieving a Disease Activity Score 28 (DAS28) of < 2.6|"The DAS28 was calculated using the tender and swollen joint counts, c-reactive Protein (CRP), or erythrocyte sedimentation rate (ESR), and the Patient’s Global Assessment of Disease Activity (PtGADA). The joint assessment was carried out on 28 joints.
For the analysis, DAS28 values were categorized into the following groups:
DAS28 < 2.6: clinical remission
DAS28 from 2.6 to ≤ 3.2: low disease activity
DAS28 from > 3.2 to 5.1: moderate disease activity
DAS28 > 5.1: high disease activity"|From Baseline to Visit 9 (around Week 104)|Full Analysis Set (FAS) using Non-Responder Imputation (NRI). FAS is defined as all patients with a DAS28 ≥ 2.6 at baseline who took at least 1 dose of Certolizumab Pegol and had at least 1 valid post-Baseline DAS28 value.||percentage of participants||95% Confidence Interval|Number
812001|NCT01069484|Secondary|Urinary Incontinence (Positive Pad Test)|"Urinary incontinence assessed by pad test, as described by Mørkved and Bø (1997). The cutoff value for a positive test was 2 gram.
After voiding, the women drank one litre of water. Thirty minutes later they wore a pre-weighted pad and performed a stress test as follows:
Jumping up and down with maximal intensity for 30 seconds.
Jumping with the legs in alternate abduction and adduction (Jumping Jacks) with maximal intensity for another 30 seconds.
Coughing as hard as possible three times. As in the study by Mørkved and Bø (1997), a positive pad-test was set to a cut-off of 2 gram of leakage."|6 months postpartum (end of intervention)|Primiparous women who delivered a singleton baby vaginally after more than 32 weeks of gestation. They had to have Scandinavian language skills, no severe perineal tearing, no prior abortion or stillbirth after 16 weeks of gestation, and no illnesses interfering with the ability to follow-up.||participants|||Number
812002|NCT01069484|Primary|Urinary Incontinence (Prevalence)|Urinary incontinence was assessed by The International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI Short Form questionnaire, www.iciq.net). Women were considered as incontinent if they reported to leak urine (yes/no) at any frequency.|6 months postpartum (end of intervention)|Primiparous women who delivered a singleton baby vaginally after more than 32 weeks of gestation. They had to have Scandinavian language skills, no severe perineal tearing, no prior abortion or stillbirth after 16 weeks of gestation, and no illnesses interfering with the ability to follow-up.||participants|||Number
812003|NCT01069523|Secondary|Clinical Global Impression- Improvement|Blinded clinician overall assessment of the child global improvement in behavior-1 is very much improved, 2-much improved, 3- minimally improved, 4 no change, 5-minimally worse, 6- much worse, 7- very much worse|Week 4 of study|||units on a scale||Standard Deviation|Mean
812004|NCT01069523|Primary|Dupaul ADHD Rating Scale|54 point scales assessing ADHD symptoms in a dimensional manner. 0 is no ADHD symptoms while 54 is severe. A score of 18 or below is the normative range.|Baseline and Follow up|||units on a scale||Standard Deviation|Mean
812005|NCT01069562|Secondary|INTRA OPERATIVE PHENYLEPHRINE USED|The amount of phenylephrine used during the procedure.|8 hours (approximately)|All the patients who were randomized completed the study protocol and were included for analysis||.µg/kg||Standard Deviation|Mean
812006|NCT01069562|Secondary|Intra Operative Adrenaline Used|The amount of adrenaline used during the procedure|8 hours (approximately)|All the patients who were randomized completed the study protocol and were included for analysis||µg/kg||Standard Deviation|Mean
812007|NCT01069562|Secondary|Fentanyl Used|The total amount of fentanyl that was used during the procedure.|8 hours (approximately)|All the patients who were randomized completed the study protocol and were included for analysis||µg/kg||Standard Deviation|Mean
812008|NCT01069562|Secondary|Intra-operative Awareness|The number of patients who were able to recall the intra-operative events when assessed postoperatively. This was assessed by a structured protocol|3 days (approximately)|All the patients who were randomized completed the study protocol and were included for analysis||participants|||Number
824783|NCT01178268|Secondary|Follow-up In-stent Angiographic Binary Restenosis (ABR)||≥13 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|Participants||Number
812010|NCT01069562|Secondary|Percentage of Time Heart Rate Remained Within 25% of Pre-op Baseline|The duration of time heart rate remained within 25% of the pre-operative baseline value during the period isoflurane (general anesthetic) was administered to the study population. This value is expressed as a percentage. This outcome is expressed as the mean of percentage of time per participant.|8 hours (approximately)|All the patients who were randomized completed the study protocol and were included for analysis||percentage of time||Standard Deviation|Mean
812011|NCT01069562|Secondary|Wobble|Wobble measures the intra-individual variability in performance error.The median of the difference between individual performance errors throughout anesthesia and the median performance error for each participant is the wobble of that participant. The mean value per participant is indicated in the outcome measure.|8 hours (approximately)|All the patients who were randomized completed the study protocol and were included for analysis||percentage of BIS||Standard Deviation|Mean
812012|NCT01069562|Secondary|Median Absolute Performance Error (MDAPE)|The median of the absolute values of performance errors (without considering the direction of error) is median absolute performance error. This outcome measures the magnitude of error or inaccuracy of the system studied. A lower value indicates a more precise system.This outcome is expressed as the mean of Median Absolute Performance Errors per participant.|8 hours (approximately)|All the patients who were randomized completed the study protocol and were included for analysis||percentage deviation of absolute BIS||Standard Deviation|Mean
812013|NCT01069562|Secondary|Median Performance Error (MDPE)|The difference between the observed and target of measure of depth of anesthesia (BIS) expressed as percentage of target BIS is calculated as performance error every 30 seconds. This value may be either ‘+’ or ‘_’ indicating whether the observed measure is above the target (overshoot-+) or below the target (undershoot-_). The median value of all performance errors during isoflurane anesthesia is median performance error and is a measure of bias of the system. This outcome is expressed as the mean of Median Performance Errors per participant.|8 hours (approximately)|All the patients who were randomized completed the study protocol and were included for analysis||percentage deviation of BIS from target||Standard Deviation|Mean
812014|NCT01069562|Primary|Percentage of Time Bispectral Index Remains Within 10 of Target BIS of 50|The duration of time depth of anesthesia was maintained in the recommended range (as measured by BIS) during the period isoflurane (general anesthetic) was administered to the study population. This value expressed as percentage is the primary outcome. BIS is an objective measure of depth of anesthesia derived from statistical(bispectral) analysis of electroencephalographic waves. BIS ranges from 0 to 100. It decreases monotonically from 100 in the awake state to lower values with sedation and anesthesia.|8 hours (approximately)|All the patients who were randomized completed the study protocol and were included for analysis||percentage of time||Standard Deviation|Mean
812015|NCT01069627|Secondary|Time to Overall Response of CR or PR - Time to Event|The time between date of start of treatment until first documented response of CR or PR. This analysis included all responders. Participants who did not achieve a confirmed CR or PR were censored at last adequate tumor assessment date or at maximum follow-up. Mean time to CR or PR was estimated using the Kaplan-Meier method.|Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months|ITT Population; only participants with a response of CR or PR were included in the analysis.||days||Standard Deviation|Mean
812016|NCT01069627|Secondary|Time to Overall Response of CR or PR - Percentage of Participants With an Event|The time between date of start of treatment until first documented response of CR or PR. This analysis included all responders. Participants who did not achieve a confirmed CR or PR were censored at last adequate tumour assessment date or at maximum follow-up.|Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months|ITT Population; data for 1 participant were not assessable as the participant was discontinued from the study due to a protocol violation.||percentage of participants|||Number
812017|NCT01069627|Secondary|Time to CR - Time To Event|The time between date of start of treatment until first documented CR. This analysis included all responders. Participants who did not achieve a confirmed CR were censored at last adequate tumour assessment date or at maximum follow-up. Mean time to CR was estimated using the Kaplan-Meier method.|Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months|ITT population; only participants with a CR were included in the analysis.||days||Standard Deviation|Mean
812018|NCT01069627|Secondary|Time to CR - Percentage of Participants With an Event|The time between date of start of treatment until first documented CR. This analysis included all responders. Participants who did not achieve a confirmed CR were censored at last adequate tumour assessment date or at maximum follow-up.|Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months|ITT Population; data for 1 participant were not assessable as the participant was discontinued from the study due to a protocol violation.||percentage of participants|||Number
812019|NCT01069627|Secondary|TTF - Time to Event|The time from date of start of treatment to the earliest among date of progression, date of death due to any cause, or date of discontinuation due to reason other than ‘Protocol Violation’ or ‘Administrative Problem’. For the participants who did not experience treatment failure, TTF was censored at last adequate tumour assessment. Median TTF was estimated using the Kaplan-Meier method.|Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months|ITT population; data for 1 participant were not assessable as the participant was discontinued from the study due to a protocol violation.||days||95% Confidence Interval|Median
812020|NCT01069627|Secondary|Time to Treatment Failure (TTF) - Percentage of Participants With an Event|The time from date of start of treatment to the earliest among date of progression, date of death due to any cause, or date of discontinuation due to reason other than ‘Protocol Violation’ or ‘Administrative Problem’. For the participants who did not experience treatment failure, TTF was censored at last adequate tumour assessment.|Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months|ITT Population; data for 1 participant were not assessable as the participant was discontinued from the study due to a protocol violation.||percentage of participants|||Number
812021|NCT01069627|Secondary|OS - Time to Event|The time from the starting day of the therapy up to death or the last date the participant was known to be alive. Median OS was estimated using the Kaplan-Meier method.|Baseline, every 3 weeks to end-of-treatment, every 3 months during follow-up, to death or end-of-study (maximum of 36 months)|ITT population||days||95% Confidence Interval|Median
812023|NCT01069627|Secondary|Duration of Stable Disease - Time to Event|Stable disease was defined as achieving CR, PR, or SD. The start date was the date of first documented CR, PR, or SD and the end date was defined as the date of first documented progression of disease, or death. Participants who did not experience progression of disease were censored at last tumor assessment date or at maximum follow-up. Median duration of CR, PR, or SD was estimated using the Kaplan-Meier method.|Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months|ITT population; only participants with a best overall response of CR, PR, or SD were included in the analysis.||days||95% Confidence Interval|Median
812024|NCT01069627|Secondary|Duration of Stable Disease - Percentage of Participants With an Event|Stable disease was defined as achieving CR, PR, or SD. The start date was the date of first documented CR, PR, or SD and the end date was defined as the date of first documented progression of disease, or death. Participants who did not experience progression of disease were censored at last tumor assessment date or at maximum follow-up.|Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months|ITT population; only participants with a best overall response of CR, PR, or SD were included in the anlaysis.||percentage of participants|||Number
812025|NCT01069627|Secondary|Duration of Overall Response of CR or PR - Time to Event|The start date was the date of first documented CR or PR and the end date was defined as the date of first documented progression of disease. Participants who did not experience progression of disease were censored at last tumor assessment date or at maximum follow-up. Median duration of CR or PR was estimated using the Kaplan-Meier method.|Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months|ITT population; only participants with a best overall response of CR or PR were included in the analysis.||days||95% Confidence Interval|Median
812026|NCT01069627|Primary|Percentage of Participants With Clinical Benefit of CR, PR, or Stable Disease (SD)|The percentage of participants with an objective response of CR, PR, or SD, as evaluated by RECIST criteria. CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target), PR: at least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD. SD: steady state of disease. Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for pregressive disease (PD). The clinical benefit was finally assessed by computing absolute frequencies and percentages participants with best overall tumor response equal to CR, PR, or SD.|Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months|ITT population; data for 1 participant were not assessable as the participant was discontinued from the study due to a protocol violation.||percentage of participants||95% Confidence Interval|Number
812027|NCT01069627|Secondary|Duration of Overall Response of CR or PR - Percentage of Participants With an Event|The start date was the date of first documented CR or PR and the end date was defined as the date of first documented progression of disease, or death. Participants who did not experience progression of disease were censored at last tumor assessment date or at maximum follow-up.|Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months|ITT population; only participants with a best overall response of CR or PR were included in the analysis.||percentage of participants|||Number
812028|NCT01069627|Secondary|Duration of CR - Time to Event|The start date was the date of first documented CR and the end date was defined as the date of first documented progression of disease, or death. Participants who did not experience progression of disease were censored at last tumor assessment date or at maximum follow-up. Median duration of CR was estimated using the Kaplan-Meier method.|Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months|ITT population; only participants with a CR were included in the analysis||days||95% Confidence Interval|Median
812029|NCT01069627|Secondary|Duration of CR - Percentage of Participants With an Event|Evaluated only for participants whose best overall response was CR. The start date was the date of first documented CR and the end date was defined as the date of first documented progression of disease, or death. Participants who did not experience progression of disease were censored at last tumor assessment date or at maximum follow-up.|Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months|ITT population; only participants with a best overall response of CR were included in the analysis.||percentage of participants|||Number
812030|NCT01069627|Secondary|TTP - Time to Event|TTP was defined as the time in days from the of first study treatment until the date of tumor progression or death. Failure events were defined as occurrence of death or progression of disease. Data for participants who were alive without tumor progression at the end of the study were censored at the end of the observation period. Median TTP was estimated using the Kaplan-Meier method.|Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months|ITT population; data for 1 participant were not assessable as the participant was discontinued from the study due to a protocol violation.||days||95% Confidence Interval|Median
812031|NCT01069627|Secondary|Time to Progression (TTP) - Percentage of Participants With an Event|TTP was defined as the time in days from the date of first study treatment until the date of tumor progression or death. Failure events were defined as occurrence of death or progression of disease. Data for participants who were alive without tumor progression at the end of the study were censured at the end of the observation period.|Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months|ITT population; data for 1 participant were not assessable as the participant was discontinued from the study due to a protocol violation.||percentage of participants|||Number
812032|NCT01069627|Primary|Percentage of Participants With Complete Response (CR) or Partial Response (PR)|The percentage of participants with an objective response, defined as achieving CR or PR, as evaluated by the Response Evaluation Criteria In Solid Tumors (RECIST) criteria. CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target), PR: at least a 30 percent (%) decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.|Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months|Intent-to-Treat (ITT) Population: all participants who signed the informed consent form and were assigned a study patient number; data for 1 participant were not assessable as the participant was discontinued from the study due to a protocol violation.||percentage of participants||95% Confidence Interval|Number
812033|NCT01069861|Other Pre-specified|Duration of Study Medication|The duration of the infusion was determined as per investigator’s discretion up to Day 7 or Day 14.|Baseline up to Day 14|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early study termination.|||||
812034|NCT01069861|Secondary|Maximum Observed Plasma Concentration (Cmax) of Sildenafil Metabolite (UK-103320)||Pre-dose, 5 and 30 minutes post-loading infusion, within 48 to 72, 96 to 120 hours during infusion, within 4 to 8, 18 to 24 and 44 to 48 hours post-maintenance infusion|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early study termination.|||||
812035|NCT01069861|Secondary|Population Pharmacokinetics of Sildenafil|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Pre-dose, 5 and 30 minutes post-loading infusion, within 48 to 72, 96 to 120 hours during infusion, within 4 to 8, 18 to 24 and 44 to 48 hours post-maintenance infusion||||||
812036|NCT01069861|Secondary|Time to Receipt of Standard Therapy (Inhaled Nitric Oxide [iNO] or Extracorporeal Membrane Oxygenation [ECMO])|Time from start of treatment up to introduction of standard therapy. If participants did not receive standard therapy within 14 days after initiation of the study treatment, then Day 14 was the censoring time.|Baseline up to 28 days after last dose|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early study termination.|||||
812037|NCT01069861|Secondary|Duration of Mechanical Ventilation|The number of days from the start to the stop of mechanical ventilation, if multiple ventilations occurred during the follow-up, the sum of the duration of each ventilation was used for analyses. Mechanical ventilation was defined as use of mechanical assistance or replacement of spontaneous breathing.|Baseline up to 28 days after last dose|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early study termination.|||||
812038|NCT01069861|Secondary|Change From Baseline in Ratio of Partial Pressure of Oxygen in Arterial Blood to the Fraction of Inspired Oxygen (P/F) at Hour 6 and 12|The ratio of partial pressure of arterial oxygen and fraction of inspired oxygen is a comparison between the oxygen level in the arterial blood and the oxygen concentration that is breathed. It helps to determine the degree of any problems with how the lungs transfer oxygen to the blood.|Baseline, Hour 6, 12|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early study termination.|||||
812039|NCT01069861|Secondary|Change From Baseline in Differential Saturation (Pre- And Post-ductal) at Hour 6 and 12|Differential oxygenation saturation between preductal and postductal sites as measured by pulse oximetry. A difference of greater than (>) 5 percent (%) to 10% in saturation indicates right-to-left shunt through the ductus arteriosus. Oxygenation saturation is measured as percentage of hemoglobin binding sites occupied by oxygen in the blood.|Baseline, Hour 6, 12|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early study termination.|||||
812040|NCT01069861|Secondary|Change From Baseline in Oxygenation Index at Hour 6 and 12|Oxygenation Index (OI) was calculated as the product of fraction of inspired oxygen (FiO2) and Mean Airway Pressure divided by partial pressure of oxygen in arterial blood [(FiO2*Mean Airway Pressure)/PaO2] measured in centimeter of water/millimeter of mercury (cmH2O/mmHg). FiO2 is the measure of oxygen concentration that is breathed. Mean airway pressure is defined as an average of the airway pressure throughout the respiratory cycle. PaO2 is the measure of oxygen level in the arterial blood.|Baseline, Hour 6, 12|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early study termination.|||||
812041|NCT01069861|Primary|Number of Participants With Abnormal Laboratory Data|Criteria for potentially clinically significant (PCS) laboratory values: hematocrit 29.2 percent (%); white blood cell (WBC) count 5.0*10^3, lymphocyte absolute 0.88*10^3, total neutrophils absolute 12.07*10^3, eosinophils absolute 0.50*10^3 per cubic millimeter (/mm^3); calcium 6.8 milligram/deciliter (mg/dL); venous bicarbonate 47.0 milliequivalent/liter (meq/L).|Screening, once daily for 3 days, every 48 hours thereafter till the end of infusion (up to Day 14)|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early study termination.|||||
812042|NCT01069861|Primary|Number of Participants With Adverse Events (AEs) Based on Severity|AE:any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. SAE:AE resulting in any of following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience; persistent/significant disability/incapacity; congenital anomaly. Severity criteria: “mild=does not interfere with participant's usual function; moderate=interferes to some extent with participant's usual function and severe=interferes significantly with participant's usual function”.|Baseline up to 28 days after last dose|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early study termination.|||||
812043|NCT01069861|Primary|Percentage of Participants Requiring Inhaled Nitric Oxide (iNO) or Extracorporeal Membrane Oxygenation (ECMO)|Percentage of participants who required standard therapy (iNO or ECMO) after failure of study treatment.|From start of infusion (baseline) up to Day 14|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early study termination.|||||
812044|NCT01069900|Secondary|Bacteriological Response at the End of Treatment (EOT) Visit|Bacteriological response at EOT were grades as presumed persistence, presumed eradication or indeterminate. 'presumed persistence' was applicable for subjects judged to be clinical failures and appropriate culture material is not available for evaluation; 'presumed eradication' defined as the absence of appropriate culture material for evaluation because the subject has clinically responded (with a response as a resolution or cure) and invasive procedures are not warranted; 'indeterminate' is applicable when the bacteriological response to the study drug was not valid for any reason (eg, pretreatment culture was negative or culture was not obtained when material was available and the subject was not judged a clinical failure). Percentage of subjects with bacteriological response at EOT were reported.|Day 5 to Day 14|Safety analysis set with subjects evaluable for this outcome||Percentage of subjects|||Number
829194|NCT01225055|Secondary|Bone Mineral Density (BMD) by DXA at the Lumbar Spine.|Mean change in BMD at the lumbar spine from baseline after 12 month of treatment|12 months|||g/cm squared||95% Confidence Interval|Mean
812045|NCT01069900|Secondary|Clinical Response at the End-of-Treatment (EOT) Visit|Clinical responses at EOT were graded as resolution, failure, or indeterminate. 'Resolution' defined as a disappearance of signs and symptoms related to the infection or sufficient improvement of clinical signs and symptoms related to the infection and the subject does not require any further antibiotic therapy or surgical intervention; 'failure' defined as worsening or insufficient lessening of the signs and symptoms of infection requiring a modification or addition of antibacterial therapy; 'indeterminate' is defined as those subjects in whom a clinical assessment is not possible to determine (eg, due to early withdrawal from the study because of adverse events, protocol violation, withdrawn consent; receipt of less than 3 full days of study drug; receipt of an effective concomitant antibacterial for an indication other than study indication; etc). Percentage of subjects with clinical response at EOT were reported.|Day 5 to Day 14|Safety analysis set with subjects evaluable for this outcome||Percentage of subjects|||Number
812046|NCT01069900|Secondary|Bacteriological Response at a ‘During Therapy’ Visit|Bacteriological response during therapy were graded as presumed persistence, presumed eradication, or indeterminate'Presumed persistence' is applicable for subjects judged to be clinical failures and appropriate culture material is not available for evaluation;'presumed eradication' is defined as the absence of appropriate culture material for evaluation because the subject has clinically responded (with a response as a resolution or cure) and invasive procedures are not warranted; 'indeterminate is applicable when the bacteriological response to the study drug is not valid for any reason (eg, pretreatment culture was negative or culture was not obtained when material was available and the subject is not judged a clinical failure). Percentage of subjects with bacteriological response during therapy visit were reported|Day 3 to Day 5|Safety analysis set with subjects evaluable for this outcome||Percentage of subjects|||Number
812047|NCT01069900|Secondary|Clinical Response at a ‘During Therapy’ Visit|"Clinical responses during therapy visit were graded as clinical improvement, clinical failure, or indeterminate. Clinical improvement defined as a reduction in the severity and/or the number of signs and symptoms of infection; 'clinical failure' defined as a failure to respond or insufficient lessening of the signs and symptoms of infection requiring a modification or addition of antibacterial therapy.
'Indeterminate' defined as those subjects in whom a clinical assessment is not possible to determine (eg, due to early withdrawal from the study because of adverse events, protocol violation, withdrawn consent, receipt of an effective concomitant antibacterial for an indication other than the study indication and receipt of less than 3 full days of study drug, etc). Percentage of subjects with clinical response during therapy visit were reported."|Day 3 to Day 5|Safety analysis set with subjects evaluable for this outcome||Percentage of subjects|||Number
812048|NCT01069900|Secondary|Clinical Response at Test-of-Cure (TOC) Visit in Subjects With Bacteriologically Confirmed Complicated Intra-abdominal Infection (cIAI)|Clinical responses were graded as clinical cure, failure or indeterminate. 'Clinical cure' defined as a resolution or sufficient improvement of clinical signs and symptoms related to the infection; 'failure' defined as a reappearance of the signs and symptoms of the original infection, or wound infection requiring further systemic antimicrobial therapy; 'indeterminate' defined as those subjects in whom a clinical assessment was not possible to determine (due to early withdrawal from the study because of adverse events, protocol violation, withdrawn consent). Percentage of subjects with clinical response at TOC were reported|28 to 42 days|Safety analysis set with subjects evaluable for this outcome||Percentage of subjects|||Number
812049|NCT01069900|Secondary|Bacteriological Response at Test-of-Cure (TOC) Visit|"Bacteriological responses were graded as presumed persistence, presumed eradication or indeterminate.
'Presumed persistence' was applicable for subjects judged to be clinical failures, and appropriate culture material is not available for evaluation; 'presumed eradication' defined as the absence of appropriate culture material for evaluation because the subject has clinically responded and invasive procedures are not warranted; índeterminate' was applicable when the bacteriological response to the study drug was not valid for any reason (eg, pre-treatment culture was negative or culture was not obtained when material was available and the subject was not judged a clinical failure). Percentage of subjects with bacteriological response at TOC were reported."|28 to 42 days|Safety analysis set with subjects evaluable for this outcome||Percentage of subjects|||Number
812050|NCT01069900|Secondary|Clinical Response at Test-of-Cure (TOC) Visit|Clinical responses were graded as clinical cure, failure or indeterminate. 'Clinical cure' defined as a resolution or sufficient improvement of clinical signs and symptoms related to the infection; 'failure' defined as a reappearance of the signs and symptoms of the original infection, or wound infection requiring further systemic antimicrobial therapy; 'indeterminate' defined as those subjects in whom a clinical assessment was not possible to determine (due to early withdrawal from the study because of adverse events, protocol violation, withdrawn consent). Percentage of subjects with clinical response at TOC were reported.|28 to 42 days|Safety analysis set with subjects evaluable for this outcome||Percentage of subjects|||Number
812051|NCT01069900|Secondary|Potentially Clinically Significant Electrocardiogram (ECG) QTc Interval Prolongation - by QTc Calc Bazett Correction on Treatment Day 1 and During Therapy Day 3|"A significant QTc prolongation was considered when the QTc value was more than ULN range or was prolonged for 30 msec or 60msec in comparison with the pre-treatment value measured on Day 1. N signifies subjects who were evaluable for the specified parameter for each arm, respectively. Percentage of subjects with potentially clinically significant ECG data was reported."|Baseline (Pre-dose), Day 1, Day 3|Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.||Percentage of subjects|||Number
812052|NCT01069900|Secondary|Potentially Clinically Significant Electrocardiogram (ECG) QTc Interval Prolongation - by QTc Interval Calc Fridericia Correction on Treatment Day 1 and During Therapy Day 3|"A significant QTc prolongation was considered when the QTc value was more than (>) upper limit of normal (ULN) range or was prolonged for 30 msec or 60msec in comparison with the pre-treatment value measured on Day 1. N signifies subjects who were evaluable for the specified parameter for each arm, respectively. Percentage of subjects with potentially clinically significant ECG data was reported."|Baseline (Pre-dose), Day 1, Day 3|Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.||Percentage of subjects|||Number
812363|NCT01064739|Primary|Urinary Dopa|Urinary dopa excreted 4-8 hours after breakfast was specified as a primary outcome. Other catechols (dihydroxyphenylglycol, norepinephrine, epinephrine, dopamine, dihydroxyphenylacetic acid) and other time points (0-4 hr, 8-12 hr after breakfast) are non-primary outcomes.|4-8 hours after breakfast|||micrograms/4hr||Standard Deviation|Mean
812053|NCT01069900|Secondary|Corrected QT (QTc) Interval Calculated (Calc) Fridericia Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3|"QTc interval Calc Fridericia represent the interval corrected for heart rate (QTc) msec which was calculated by Fridericia's method. N signifies subjects who were evaluable for the specified parameter for each arm, respectively."|Baseline (Pre-dose), Day 1, Day 3|Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.||milliseconds||Standard Deviation|Mean
812054|NCT01069900|Secondary|Corrected QT (QTc) Interval Calculated (Calc) Bazett Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3|"QTc interval Calc Bazett represent the interval corrected for heart rate (QTc) milliseconds (msec) which was calculated by Bazett’s method. N signifies subjects who were evaluable for the specified parameter for each arm, respectively."|Baseline (Pre-dose), Day 1, Day 3|Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.||milliseconds||Standard Deviation|Mean
812055|NCT01069900|Secondary|QT Interval Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3|"The QT interval is the period that extends from the beginning of ventricular depolarization until the end of ventricular repolarization. N signifies subjects who were evaluable for the specified parameter for each arm, respectively."|Baseline (Pre-dose), Day 1, Day 3|Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.||milliseconds||Standard Deviation|Mean
812056|NCT01069900|Secondary|QRS Interval Changes in Electrocardiogram (ECG) Profiles From Predose to Post-dose on Treatment Day 1 and Treatment Day 3|"The QRS interval represents the time it takes for ventricular depolarization to occur. N signifies subjects who were evaluable for the specified parameter for each arm, respectively."|Baseline (Pre-dose), Day 1, Day 3|Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.||milliseconds||Standard Deviation|Mean
812057|NCT01069900|Secondary|RR Interval Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3|"The RR interval refers to the respective time interval in the Electrocardiogram. N signifies subjects who were evaluable for the specified parameter for each arm, respectively."|Baseline (Pre-dose), Day 1, Day 3|Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.||milliseconds||Standard Deviation|Mean
812058|NCT01069900|Secondary|PR Interval Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3|"The PR interval is defined as the period that extends from the onset of atrial depolarization (beginning of the P wave) until the onset of ventricular depolarization. N signifies subjects who were evaluable for the specified parameter for each arm, respectively."|Baseline (Pre-dose), Day 1, Day 3|Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.||milliseconds||Standard Deviation|Mean
812059|NCT01069900|Secondary|Heart Rate Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3|"N signifies subjects who were evaluable for the specified parameter for each arm, respectively."|Baseline (Pre-dose), Day 1, Day 3|Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.||Beats per minute (bpm)||Standard Deviation|Mean
812060|NCT01069900|Secondary|Incidence Rates of Musculoskeletal Adverse Events by Primary System Organ Class (SOC) and Preferred Term|"Musculoskeletal adverse events were classified as following SOCs (preferred terms): injury, poisoning and procedural complications (forearm fracture, joint injury, ligament sprain, muscle strain) musculoskeletal and connective tissue disorders (arthralgia, joint swelling, musculoskeletal pain, myalgia). Incidence rates were reported as percentage of subjects categorized under preferred terms."|All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.|Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.||Percentage of subjects||95% Confidence Interval|Number
812061|NCT01069900|Primary|Number of Subjects With Musculoskeletal Adverse Events||All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.|Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.||Subjects|||Number
812062|NCT01069900|Primary|Number of Subjects With Clinical Cardiac Adverse Events||Clinical cardiac event related to QT interval were recorded from treatment start until day 3 of treatment. All other clinical cardiac events were recorded from treatment start to test of cure visit, up to day 56.|Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.||Subjects|||Number
812063|NCT01069900|Primary|Number of Subjects With Adverse Events|An adverse event (AE) was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. An serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.|Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.||Subjects|||Number
812064|NCT01069939|Secondary|Number of Participants With Adverse Events|Participants who had at least adverse events (AE) which occurred after receiving study drug were counted.|Up to 70 weeks at the longest|All participants who received any study drug were included in this analysis.||Participants|||Number
812065|NCT01069939|Secondary|Change in the Severity of Discomfort in the Stomach From Baseline to Last Measurement up to Week 48|"The severity of Discomfort in the stomach at baseline and the last measurement up to 48 weeks was obtained (None, Mild, Moderate, Severe). If the value at the last was better in a participant, the participant was categorized into Improved. If the value was same, categorised into Unchanged. If the value was worsened, categorise into Worsened."|Up to 48 weeks (Baseline to last measurement)|||Participants|||Number
812873|NCT01074502|Primary|Percentage of Patients With a Minimum 2-grade Improvement in the Researcher Global Assessment (RGA) From Baseline to Week 12.|RGA measures the severity of acne. The scale goes from 0 (better)to 4 (worse). Score can only be whole numbers, ordinal.|Baseline to 12 weeks|small number of subjects to be analyzed|||||
812066|NCT01069939|Secondary|Change in the Severity of Nausea and/or Vomiting From Baseline to Last Measurement up to Week 48|"The severity of Nausea and/or Vomiting at baseline and the last measurement up to 48 weeks was obtained (None, Mild, Moderate, Severe). If the value at the last was better in a participant, the participant was categorized into Improved. If the value was same, categorised into Unchanged. If the value was worsened, categorise into Worsened."|Up to 48 weeks (Baseline to last measurement)|Participants who had the measurements of Nausea and/or Vomiting at baseline and post-dose up to 48 weeks were included in this analysis.||Participants|||Number
812067|NCT01069939|Secondary|Change in the Severity of Abdomen Enlarged Feeling From Baseline to Last Measurement up to Week|"The severity of abdomen enlarged feeling at baseline and the last measurement up to 48 weeks was obtained (None, Mild, Moderate, Severe). If the value at the last was better in a participant, the participant was categorized into Improved. If the value was same, categorised into Unchanged. If the value was worsened, categorise into Worsened."|Up to 48 weeks (Baseline to last measurement)|Participants who had the measurements of abdomen enlarged feeling at baseline and post-dose up to 48 weeks were included in this analysis.||Participants|||Number
812068|NCT01069939|Secondary|Change in the Severity of Anorexia From Baseline to Last Measurement up to Week 48|"The severity of anorexia at baseline and the last measurement up to 48 weeks was obtained (None, Mild, Moderate, Severe). If the value at the last was better in a participant, the participant was categorized into Improved. If the value was same, categorised into Unchanged. If the value was worsened, categorise into Worsened."|Up to 48 weeks (Baseline to last measurement)|Participants who had the measurements of anorexia at baseline and post-dose up to 48 weeks were included in this analysis.||Participants|||Number
812069|NCT01069939|Secondary|Change in the Severity of Heartburn From Baseline to Last Measurement up to Week 48.|"The severity of heartburn at baseline and the last measurement up to 48 weeks was obtained (None, Mild, Moderate, Severe). If the value at the last was better in a participant, the participant was categorized into Improved. If the value was same, categorised into Unchanged. If the value was worsened, categorise into Worsened."|Up to 48 weeks (Baseline to last measurement)|Participants who had the measurements of heartburn at baseline and post-dose up to 48 weeks were included in this analysis.||Participants|||Number
812070|NCT01069939|Secondary|Change in the Severity of Epigastric Pain From Baseline to Last Measurement up to Week 48|"The severity of epigastric pain at baseline and the last measurement up to 48 weeks was obtained (None, Mild, Moderate, Severe). If the value at the last was better in a participant, the participant was categorized into Improved. If the value was same, categorised into Unchanged. If the value was worsened, categorise into Worsened."|Up to 48 weeks (Baseline to last measurement)|Participants who had the measurements of epigastric pain at baseline and post-dose up to 48 weeks were included in this analysis.||Participants|||Number
812071|NCT01069939|Secondary|Number of Participants With Reflux Esophagitis Evaluated by the LA Classification up to Week 48.|Endoscopy was conducted at 12, 24, 36 and 48 weeks after randomisation. At the endoscopy, participants was evaluated whether they have reflux esophagitis or not.|12, 24, 36 and 48 weeks|Patients with endoscopy were included in the analyses at 12, 24, 36 and 48 weeks after randomisation.||Participants|||Number
812072|NCT01069939|Secondary|Change in Degree of Gastric Mucosal Lesion by Modified Lanza Scale From Baseline to Last Measurement up to Week 48|Modified Lanza scale attributes the degree of gastric mucosal lesion, graded on a 5 point scale (0=No hemorrhage, no erosion, 1=One hemorrhage or one erosions, 2=2-10 hemorrhages or erosions, 3=11-25 hemorrhages or erosions, 4=More than 25 hemorrhages or erosions, or ulcer). Higher scores indicate greater severity of gastric mucosal lesion.|Up to 48 weeks (Baseline to last measurement)|Participants who had LANZA scores at both baseline and post-dose were included into this analysis.||Scores on a scale||Standard Deviation|Mean
812073|NCT01069939|Primary|Time From Randomization to Occurrence of Gastric and/or Duodenal Ulcers up to Data Cut-off Date for Interim Analysis.|Assessments for occurrence of gastric and/or duodenal ulcers were performed every 12 weeks after randomisation. The numbers of participants with recurrence of gastric and/or duodeal ulcers were analysed every 12 weeks up to 48 weeks.|From randomisation to up to 48 weeks (Maximum follow-up period at the interim analysis)|Participants not taking investigational drug were not included. In total 364 participants were included in the efficacy evaluation at the interim analysis. 24 of the 364 total participants had an occurrence of gastric and/or duodenal ulcers by the 48-week assessment.||Participants|||Number
812074|NCT01070043|Secondary|Number of Participants With Adverse Events During Double-blind Phase||8 weeks|Safety population included all patients who received at least one study medication during the study period.||Participants|||Number
812075|NCT01070043|Secondary|Change From Baseline in Mean Diastolic Blood Pressure (mDBP) From Ambulatory Blood Pressure Measurement (ABPM) Over 24 Hours After 8 Weeks of Treatment During the Double-blind Phase|Validated automated ambulatory blood pressure monitors were dispensed to participants with instructions on correct use. Automated blood pressure readings were obtained every 15-30 minutes during waking hours and every 30-60 minutes during sleep for a total of 24 hours. The change in mean diastolic blood pressure (mDBP) over 24 hours was measured from baseline to 8 weeks of treatment during the double-blind.|Baseline and 8 weeks|The Intent-to-Treat (ITT) Population includes all participants having taken at least one dose of study medication.||mmHg||Standard Deviation|Mean
812076|NCT01070043|Secondary|Change From Baseline in Mean Systolic Blood Pressure (mSBP) From Ambulatory Blood Pressure Measurement (ABPM) Over 24 Hours|Validated automated ambulatory blood pressure monitors were dispensed to participants with instructions on correct use. Automated blood pressure readings were obtained every 15-30 minutes during waking hours and every 30-60 minutes during sleep for a total of 24 hours. The change in mean systolic blood pressure (mSBP) over 24 hours was measured from baseline to 8 weeks of treatment during the double-blind phase.|Baseline and 8 weeks|The Intent-to-Treat (ITT) Population includes all participants having taken at least one dose of study medication.||mmHg||Standard Deviation|Mean
812077|NCT01070043|Primary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) From Office Blood Pressure Measurement|Two arterial blood pressure (BP) determinations were made after the participant was in the sitting position for 5 minutes according to the American Heart Association guidelines using a calibrated standard aneroid or mercury sphygmomanometer or a calibrated standard sphygmomanometer. The change in mean sitting diastolic blood pressure (msDBP) was calculated comparing the Week 8 readings to the readings taken at Baseline.|Baseline and 8 weeks|The Intent-to-Treat (ITT) Population includes all participants having taken at least one dose of study medication.||mmHg||Standard Deviation|Mean
812078|NCT01070043|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) From Office Blood Pressure Measurement|Two arterial blood pressure (BP) determinations were made after the participant was in the sitting position for 5 minutes according to the American Heart Association guidelines using a calibrated standard aneroid or mercury sphygmomanometer or a calibrated standard sphygmomanometer. The change in mean sitting systolic blood pressure (msSBP) was calculated comparing the Week 8 readings to the readings taken at baseline.|Baseline and 8 weeks|The Intent-to-Treat (ITT) Population includes all participants having taken at least one dose of study medication.||mmHg||Standard Deviation|Mean
812079|NCT01070173|Primary|Acylated Ghrelin Level||Will be measured with baseline screening labs at enrollment.|All participants.||pg/mL||Standard Deviation|Mean
812080|NCT01070173|Primary|Total Ghrelin Level||Will be measured with baseline screening labs at enrollment.|All participants.||pg/mL||Standard Deviation|Mean
812081|NCT01070303|Secondary|Number of Participants Achieving Fistula Remission at Week 260 (Years of Participation in NCT01070303)|A count of the number of cutaneous fistulas draining upon gentle compression was performed at Baseline of the lead-in study (NCT00055523) and at study visits. Among participants with draining fistulas at Baseline of NCT00055523, a participant was considered to have achieved fistula remission at a study visit if the participant had no draining cutaneous fistulas at that visit.|From Baseline of lead-in study to Week 260|The analysis population was observed cases, that is, all participants who draining fistulas at Baseline of NCT00055523 and who had data on draining fistulas(yes or no) at Week 260.||Participants|||Number
812082|NCT01070303|Secondary|Number of Participants Achieving Fistula Remission at Week 212 (3 Years of Participation in NCT01070303)|A count of the number of cutaneous fistulas draining upon gentle compression was performed at Baseline of the lead-in study (NCT00055523) and at study visits. Among participants with draining fistulas at Baseline of NCT00055523, a participant was considered to have achieved fistula remission at a study visit if the participant had no draining cutaneous fistulas at that visit.|From Baseline of lead-in study to Week 212|The analysis population was observed cases, that is, all participants who draining fistulas at Baseline of NCT00055523 and who had data on draining fistulas(yes or no) at Week 212.||Participants|||Number
812083|NCT01070303|Secondary|Number of Participants Achieving Fistula Remission at Week 152 (2 Years of Participation in NCT01070303)|A count of the number of cutaneous fistulas draining upon gentle compression was performed at Baseline of the lead-in study (NCT00055523) and at study visits. Among participants with draining fistulas at Baseline of NCT00055523, a participant was considered to have achieved fistula remission at a study visit if the participant had no draining cutaneous fistulas at that visit.|From Baseline of lead-in study to Week 152|The analysis population was observed cases, that is, all participants who draining fistulas at Baseline of NCT00055523 and who had data on draining fistulas(yes or no) at Week 152.||Participants|||Number
812084|NCT01070303|Secondary|Number of Participants Achieving Fistula Remission at Week 104 (1 Year of Participation in NCT01070303)|A count of the number of cutaneous fistulas draining upon gentle compression was performed at Baseline of the lead-in study (NCT00055523) and at study visits. Among participants with draining fistulas at Baseline of NCT00055523, a participant was considered to have achieved fistula remission at a study visit if the participant had no draining cutaneous fistulas at that visit.|From Baseline of lead-in study to Week 104|The analysis population was observed cases, that is, all participants who draining fistulas at Baseline of NCT00055523 and who had data on draining fistulas(yes or no) at Week 104.||Participants|||Number
812085|NCT01070303|Secondary|Changes in Inflammatory Bowel Disease Questionnaire (IBDQ) Scores|"IBDQ is a validated disease−specific instrument that assesses the impact of IBD on patient quality of life during a 2−week recall period. It has 32 questions about bowel function and related symptoms, and their social and emotional impact. For each question, participants selected 1 of 7 responses, where 1=poor quality of life (e.g., feeling of fatigue all of the time) and 7=good quality on the item (e.g., feeling of fatigue none of the time). IBDQ scores range from 32 to 224. Higher scores indicate better quality of life, and increases in IBDQ indicate improved overall quality of life."|Change from Baseline of lead-in study at Weeks 104, 152, 200, and 248|The analysis population is observed cases, that is, all participants who had an IBDQ score at the visit time point.||Scores on a scale||Standard Deviation|Mean
812086|NCT01070303|Secondary|Number of Participants Achieving Steroid-free CR-100 at Week 260 (4 Years of Participation in NCT01070303)|Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free CR-100 was achieved if the participant stopped taking steroids before the visit and had a decrease from Baseline in CDAI score of 100 or more points at that visit.|From Baseline of lead-in study to Week 260|The analysis population was observed cases, that is, all participants who were taking systemic corticosteroids at Baseline of NCT00055523 and who had CDAI evaluation and documentation of concomitant corticosteroid use (yes or no) at Week 260.||Participants|||Number
812087|NCT01070303|Secondary|Number of Participants Achieving Steroid-free CR-100 at Week 212 (3 Years of Participation in NCT01070303)|Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free CR-100 was achieved if the participant stopped taking steroids before the visit and had a decrease from Baseline in CDAI score of 100 or more points at that visit.|From Baseline of lead-in study to Week 212|The analysis population was observed cases, that is, all participants who were taking systemic corticosteroids at Baseline of NCT00055523 and who had CDAI evaluation and documentation of concomitant corticosteroid use (yes or no) at Week 212.||Participants|||Number
812088|NCT01070303|Secondary|Number of Participants Achieving Steroid-free CR-100 at Week 152 (2 Years of Participation in NCT01070303)|Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free CR-100 was achieved if the participant stopped taking steroids before the visit and had a decrease from Baseline in CDAI score of 100 or more points at that visit.|From Baseline of lead-in study to Week 152|The analysis population was observed cases, that is, all participants who were taking systemic corticosteroids at Baseline of NCT00055523 and who had CDAI evaluation and documentation of concomitant corticosteroid use (yes or no) at Week 152.||Participants|||Number
812196|NCT01063764|Secondary|Number of Seizure-free Subjects Over the 10-weeks Evaluation Period|"Seizure-free means not having a seizure of type I (Partial seizure).
Partial seizures can be classified into one of the following three groups:
Simple partial seizures
Complex partial seizures
Partial seizures evolving to secondarily generalized seizures."|10-weeks Evaluation Period (Part of the first Period: Week 12 to Week 22)|Of the 73 subjects in the FAS, 68 subjects had available data over the Evaluation Period.||participants|||Number
812089|NCT01070303|Secondary|Number of Participants Achieving Steroid-free CR-100 at Week 104 (1 Year of Participation in NCT01070303)|Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free CR-100 was achieved if the participant stopped taking steroids before the visit and had a decrease from Baseline in CDAI score of 100 or more points at that visit.|From Baseline of lead-in study to Week 104|The analysis population was observed cases, that is, all participants who were taking systemic corticosteroids at Baseline of NCT00055523 and who had CDAI evaluation and documentation of concomitant corticosteroid use (yes or no) at Week 104.||Participants|||Number
812090|NCT01070303|Secondary|Number of Participants Achieving Steroid-free Clinical Remission at Week 260 (4 Years of Participation in NCT01070303)|Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free remission was achieved if the participant stopped taking corticosteroids before the visit and had a CDAI score < 150 points at that visit.|From Baseline of lead-in study to Week 260|The analysis population was observed cases, that is, all participants who were taking systemic corticosteroids at Baseline of NCT00055523 and who had CDAI evaluation and documentation of concomitant corticosteroid use (yes or no) at Week 260.||Participants|||Number
812091|NCT01070303|Secondary|Number of Participants Achieving Steroid-free Clinical Remission at Week 212 (3 Years of Participation in NCT01070303)|Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free remission was achieved if the participant stopped taking corticosteroids before the visit and had a CDAI score < 150 points at that visit.|From Baseline of lead-in study to Week 212|The analysis population was observed cases, that is, all participants who were taking systemic corticosteroids at Baseline of NCT00055523 and who had CDAI evaluation and documentation of concomitant corticosteroid use (yes or no) at Week 212.||Participants|||Number
812092|NCT01070303|Secondary|Number of Achieving Steroid-free Clinical Remission at Week 152 (2 Years of Participation in NCT01070303)|Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free remission was achieved if the participant stopped taking corticosteroids before the visit and had a CDAI score < 150 points at that visit.|From Baseline of lead-in study to Week 152|The analysis population was observed cases, that is, all participants who were taking systemic corticosteroids at Baseline of NCT00055523 and who had CDAI evaluation and documentation of concomitant corticosteroid use (yes or no) at Week 152.||Participants|||Number
812093|NCT01070303|Secondary|Number of Participants Achieving Steroid-free Clinical Remission at Week 104 (1 Year of Participation in NCT01070303)|Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free remission was achieved if the participant stopped taking corticosteroids before the visit and had a CDAI score < 150 points at that visit.|From Baseline of lead-in study to Week 104|The analysis population was observed cases, that is, all participants who were taking systemic corticosteroids at Baseline of NCT00055523 and who had CDAI evaluation and documentation of concomitant corticosteroid use (yes or no) at Week 104.||Participants|||Number
812094|NCT01070303|Secondary|Number of Participants Achieving CR-70 at Week 260 (4 Years of Participation in NCT01070303)|A CR-70 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 70 or more points, indicating a significant improvement in disease severity. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity.|From Baseline of lead-in study to Week 260|The analysis population is observed cases, that is, all participants who had CDAI evaluation at Week 260 are included.||Participants|||Number
812095|NCT01070303|Secondary|Number of Participants Achieving CR-70 at Week 212 (3 Years of Participation in NCT01070303)|CR-70 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 70 or more points, indicating a significant improvement in disease severity. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity.|From Baseline of lead-in study to Week 212|The analysis population is observed cases, that is, all participants who had CDAI evaluation Week 212 are included.||Participants|||Number
812096|NCT01070303|Secondary|Number of Participants Achieving CR-70 at Week 152 (2 Years of Participation in NCT01070303)|A CR-70 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 70 or more points, indicating a significant improvement in disease severity. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity.|From Baseline of lead-in Study to Week 152|The analysis population is observed cases, that is, all participants who CDAI evaluation at Week 152 are included.||Participants|||Number
812097|NCT01070303|Secondary|Number of Participants Achieving CR-70 at Week 104 (1 Year of Participation in NCT01070303)|A CR-70 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 70 or more points, indicating a significant improvement in disease severity. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity.|Week 104|The analysis population is observed cases, that is, all participants who had CDAI evaluation at Week 104 .||Participants|||Number
812098|NCT01070303|Secondary|Number of Participants Achieving CR-100 at Week 260 (4 Years of Participation in NCT01070303)|A CR-100 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 100 or more points, indicating significant improvement in disease severity. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity.|From Baseline of lead-in study to Week 260|The analysis population is observed cases, that is, all participants who had CDAI evaluation at Week 260 are included.||Participants|||Number
812099|NCT01070303|Secondary|Number of Participants Achieving CR-100 at Week 212 (3 Years of Participation in NCT01070303)|A CR-100 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 100 or more points, indicating a significant improvement in disease severity. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity.|From Baseline of lead-in study to Week 212|The analysis population is observed cases, that is, all participants who had CDAI evaluation at Week 212||Participants|||Number
812100|NCT01070303|Secondary|Number of Participants Achieving CR-100 at Week 152 (2 Years of Participation in NCT01070303)|A CR-100 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 100 or more points, indicating a significant improvement in disease severity. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity.|From Baseline of lead-in study to Week 152|The analysis population is observed cases, that is, all participants who had CDAI evaluation at Week 152 are included.||Participants|||Number
812101|NCT01070303|Secondary|Number of Participants Achieving CR-100 at Week 104 (1 Year of Participation in NCT01070303)|A CR-100 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 100 or more points, indicating significant improvement in disease severity. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity.|From Baseline of lead-in study to Week 104|The analysis population is observed cases, that is, all participants who had CDAI evaluation at Week 104 of Study NCT00055497 are included.||Participants|||Number
812102|NCT01070303|Secondary|Number of Participants Achieving Clinical Remission (CDAI < 150 Points) at Week 260 (4 Years of Participation in NCT01070303).|Clinical remission is defined as CDAI score <150. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. A lower score indicates less severe Crohn's disease activity.|Week 260|The analysis population is observed cases, that is, all participants who had CDAI evaluation at Week 260 of Study NCT00055497 are included.||Participants|||Number
812103|NCT01070303|Secondary|Number of Participants Achieving Clinical Remission (CDAI < 150 Points) at Week 212 (Through 3 Years of Participation in NCT01070303).|Clinical remission is defined as CDAI score <150. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. A lower score indicates less severe Crohn's disease activity.|Week 212|Observed cases, that is, all participants who participating at Week 212 and had a CDAI measurement at that time point were included.||Participants|||Number
812104|NCT01070303|Secondary|Number of Participants Achieving Clinical Remission (CDAI < 150 Points) at Week 152 (Through 2 Years of Participation in NCT01070303).|Clinical remission is defined as CDAI score <150. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. A lower score indicates less severe Crohn's disease activity.|Week 152|The analysis population is observed cases, that is, all participants who had CDAI evaluation at Week 152 are included.||Participants|||Number
812105|NCT01070303|Primary|Number of Participants Achieving Clinical Remission (Crohn's Disease Activity Index[CDAI] <150 Points) at Week 104 of Study M02-433 (Starting From Week 0 of NCT00055497) (Through 1 Year of Participation in NCT01070303).|Clinical remission is defined as CDAI score <150. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. A lower score indicates less severe Crohn's disease activity.|Week 104|The analysis population is observed cases, that is, all participants who had CDAI evaluation at Week 104 are included.||Participants|||Number
812106|NCT01070316|Primary|Number of Participants Continuing Study Medication Over Time||Individual subjects will be assessed every 6 months for up to 48 months; aggregate analysis will take place at end of study|||participants|||Number
812107|NCT01070316|Primary|Reduction in Seizure Frequency|The primary efficacy endpoint was the percentage of participants demonstrating a 50% or greater reduction in seizure frequency at the end of the maintenance phase (weeks 13-16) compared to baseline (weeks 1-4)|Baseline (Weeks 1-4), Week 16|||percentage|||Number
812108|NCT01070329|Secondary|Number of Participants With Suicidal Behaviors, Ideations, and Acts Based on the Columbia Suicide Severity Rating Scale (C-SSRS) During the Double-Blind Treatment Phase|"The C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors, ideations, and acts are provided. Suicidal behavior: a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, and completed suicide. Suicidal ideation: a yes answer to any 1 of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation. Suicidal acts: a yes answer to actual attempt or completed suicide."|Baseline through 8 weeks|All randomized participants with a baseline and at least 1 post-baseline C-SSRS result.||participants|||Number
812109|NCT01070329|Secondary|Patient Global Impression of Improvement (PGI-I) Score at Week 8|A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, and treatment*visit interaction.|8 weeks|All randomized participants with a baseline and at least 1 post-baseline result.||units on a scale||Standard Error|Least Squares Mean
812197|NCT01063764|Secondary|Number of Seizure-free Subjects Over the 14-weeks Treatment Period|"Seizure-free means not having a seizure of type I (Partial seizure).
Partial seizures can be classified into one of the following three groups:
Simple partial seizures
Complex partial seizures
Partial seizures evolving to secondarily generalized seizures."|14-weeks Treatment Period (First Period: 4 weeks Up-titration (Week 8-12) and 10 weeks Evaluation (Week 12-22))|Full Analysis Set (FAS).||participants|||Number
812110|NCT01070329|Secondary|Change From Baseline in the Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 8|Measures pain severity and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference=average of nonmissing scores of individual interference items. LS Mean Value adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.|Baseline, 8 weeks|All randomized participants with a baseline and at least 1 post-baseline result.||units on a scale||Standard Error|Least Squares Mean
812111|NCT01070329|Other Pre-specified|Number of Participants With Abnormal Laboratory Values During the Double-Blind Treatment Phase - High Creatinine|Laboratory assessment of creatinine during the double-blind treatment phase. Normal creatinine ranges for males are 40.00 micromoles per liter (µmol/L) (low) to 110.00 µmol/L (high). Normal creatinine ranges for females are 31.00 µmol/L (low) to 101.00 µmol/L (high).|Baseline through 8 weeks|All randomized participants with a normal baseline (respective to the specified direction) and at least 1 post-baseline result.||participants|||Number
812112|NCT01070329|Other Pre-specified|Change From Baseline in Weight up to Week 8|"The change from baseline in weight at week 8 is the primary analysis. For the primary analysis of weight, the Least Squares (LS) Mean Value was adjusted for treatment, investigator, baseline, treatment*visit interaction, and baseline*visit interaction.
The change from baseline in weight up to week 8 is the secondary analysis. The LS Mean Value was adjusted for treatment, investigator, and baseline."|Baseline, up to week 8|"Primary analysis: All randomized participants with a baseline and at least 1 post-baseline result.
Secondary analysis: All randomized participants with a baseline and at least 1 nonmissing post-baseline result, Last Observation Carried Forward (LOCF)."||kilograms (kg)||Standard Error|Least Squares Mean
812113|NCT01070329|Secondary|Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 2|The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range from 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.|Baseline, 2 weeks|All randomized participants with a baseline and at least 1 post-baseline result.||units on a scale||Standard Error|Least Squares Mean
812114|NCT01070329|Other Pre-specified|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Up to Week 8|"The change from baseline in SBP and DBP at week 8 is the primary analysis. For the primary analysis of SBP and DBP, the Least Squares (LS) Mean Value was adjusted for treatment, investigator, baseline, treatment*visit interaction, and baseline*visit interaction.
The change from baseline in SBP and DBP up to week 8 is the secondary analysis. The LS Mean Value was adjusted for treatment, investigator, and baseline."|Baseline, up to week 8|"Primary analysis: All randomized participants with a baseline and at least 1 post-baseline result.
Secondary analysis: Intent-to-treat (ITT) population with nonmissing baseline value and at least 1 nonmissing post-baseline value, Last Observation Carried Forward (LOCF)."||mm Hg||Standard Error|Least Squares Mean
812115|NCT01070329|Other Pre-specified|Change From Baseline in Pulse Rate up to Week 8|"The change from baseline in pulse rate at week 8 is the primary analysis. For the primary analysis of pulse rate, the Least Squares (LS) Mean Value was adjusted for treatment, investigator, baseline, treatment*visit interaction, and baseline*visit interaction.
The change from baseline in pulse rate up to week 8 is the secondary analysis. The LS Mean Value was adjusted for treatment, investigator, and baseline."|Baseline, up to week 8|"Primary analysis: All randomized participants with a baseline and at least 1 post-baseline result.
Secondary analysis: Intent-to-treat (ITT) population with nonmissing baseline value and at least 1 nonmissing post-baseline value, Last Observation Carried Forward (LOCF)."||beats per minute (bpm)||Standard Error|Least Squares Mean
812116|NCT01070329|Secondary|Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 4|The MADRS is a rating scale for severity of depressive mood and symptoms. The MADRS has a 10-item checklist. Items are rated on a scale from 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.|Baseline, 4 weeks|All randomized participants with a baseline and at least 1 post-baseline result.||units on a scale||Standard Error|Least Squares Mean
812117|NCT01070329|Secondary|Percentage of Participants Achieving Remission up to Week 8|The Montgomery-Asberg Depression Rating Scale (MADRS) is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale from 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Remission is defined as achieving a MADRS total score ≤12 at the last 2 nonmissing visits (for example, visit 3 [week 1] and visit 4 [week 2], or visit 4 [week 2] and visit 5 [week 4], or visit 5 [week 4] and visit 6 [week 8]).|Up to 8 weeks|All randomized participants with a baseline and at least 1 post-baseline value.||percentage of participants|||Number
812118|NCT01070329|Secondary|Change From Baseline in the Percentage of Participants Achieving Remission up to Week 8|The Montgomery-Asberg Depression Rating Scale (MADRS) is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Remission is defined as achieving a MADRS total score ≤12.|Baseline, up to 8 weeks|All randomized participants with a baseline and at least 1 post-baseline result, Last Observation Carried Forward (LOCF).||percentage of participants|||Number
812119|NCT01070329|Secondary|Change From Baseline in the Sheehan Disability Scale (SDS) Total and Item Scores at Week 8|SDS is completed by participant; used to assess effect of the participant's symptoms on their work/social/family life. Total scores range from 0 to 30; higher values indicate greater disruption in the participant's work/social/family life. Each item score ranges from 0 to 10 with higher values indicating greater disruption in the participant's work/school life (item 1), social life/leisure activities (item 2), or family life/home responsibilities (item 3). The LS Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.|Baseline, 8 weeks|All randomized participants with a baseline and at least 1 post-baseline result.||units on a scale||Standard Error|Least Squares Mean
812120|NCT01070329|Primary|Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 8|The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.|Baseline, 8 weeks|All randomized participants with a baseline and at least 1 post-baseline result.||units on a scale||Standard Error|Least Squares Mean
812121|NCT01070329|Primary|Change From Baseline in the Brief Pain Inventory-Short Form (BPI-SF) Average Pain Score During the 8-Week Treatment Period|A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). The overall change is based on the estimated main treatment effect. The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.|Day 1 through 8 weeks|All randomized participants with a baseline and at least 1 post-baseline result.||units on a scale||Standard Error|Least Squares Mean
812122|NCT01070381|Primary|Overall Comfort|Overall Comfort, as interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 1-week's wear time. Overall comfort is measured on a 10-point scale, with 1 being poor and 10 being excellent.|1 week of wear|Analysis conducted per protocol, with exclusions due to reasons such as, major protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Units on a Scale||Standard Deviation|Mean
812123|NCT01070394|Secondary|Psychometric Validation of AMSES|To perform secondary psychometric validations of the AMSES using Cronbach's alpha coefficients.|Weeks 0-12|||Cronbach's alpha coefficients|||Number
812124|NCT01070394|Secondary|Psychometric Validation of AMRS|To perform secondary psychometric validations of the AMRS using Cronbach's alpha coefficients.|Weeks 0-12|||Cronbach's alpha coefficients|||Number
812125|NCT01070394|Primary|ADHD-RS|The ADHD-RS is a clinician-administered, semistructured scale that is designed to assess current symtomatology. It consists of 18 items that directly correspond to the DSM-IV symptoms of ADHD and each item is scored on a 4-pt scale ranging from 0 (none) to 3 (severe). It has been standardized to children but has been shown to be sensitive to drug effects in adults with ADHD. Presented will be the change in score of the ADHD-RS Total Score from baseline to Visit 12 (positive score signifies that the Total Score was greater at baseline than at Visit 12).|12 weeks|||score change from baseline to visit 12||Standard Deviation|Mean
812126|NCT01070394|Secondary|Correlation Between In-Clinic AMRS and ASRS v.1.1 Symptom Checklist|To correlate symptom rebound throughout a single day (assessed via the AMRS, In Clinic) with a self-assessment of ADHD symptoms (the ASRS v.1.1 Symptom Checklist). Pearson's correlation coefficient will be presented.|Baseline to Week 12|||Pearson's correlation coefficient|||Number
812127|NCT01070394|Secondary|Correlation Between AMRS and TASS|To correlate symptom rebound through a single day (assessed via the AMRS) with a time-sensitive (TASS) measure of efficacy of LDX treatment. A Pearson's correlation coefficient will be presented.|Visits 0 and 12|||Pearson's correlation coefficient|||Number
812128|NCT01070394|Secondary|Correlation Between AMRS (In Clinic) and ADHD-RS|To correlate symptom rebound through a single day (assessed via the AMRS) with a global (ADHD-RS) measure of efficacy of LDX treatment. The Pearson's correlation coefficients for the In-Clinic assessment will be presented.|Visits 0 and 12|||Pearson's correlation coefficient|||Number
812129|NCT01070394|Secondary|Smoothness of Effect|To evaluate smoothness of effect throughout a single day (assessed via the AMSES) of LDX treatment. Presented will be the change in score of the ADHD-RS Total Score from baseline to Visit 12 (positive score signifies that the Total Score was greater at baseline than at Visit 12).|Visits 0 and 12|||score change from baseline to visit 12||Standard Deviation|Mean
812130|NCT01070394|Secondary|Symptom Rebound|To evaluate the symptom rebound throughout a single day (assessed via the AMRS) with LDX treatment. Presented will be the change in score of the AMRS Total Score from baseline to Visit 12 (positive score signifies that the Total Score was greater at baseline than at Visit 12).|Visits 0 and 12|||score change from baseline to visit 12||Standard Deviation|Mean
812131|NCT01063036|Secondary|Number of Participants on Treatment With Study Drug With Laboratory Test Abnormalities Meeting Selected Criteria on Treatment - Treated Population|Selected criteria presented in each category. Upper limit of normal among all laboratory ranges (ULN); Baseline (BL); alanine transaminase (ALT); milligram per deciliter (mg/dL); milliliters per minute (mL/min); greater than (>);greater than, equal to (>=); less than (<). Creatinine data presented below were confirmed, ie, at least 2 consecutive values. On-treatment = after Day 1 through last dose of study therapy + 5 days.|Day 1 to last dose of study drug plus 5 days; up to Week 96|N=treated participants with on-treatment laboratory test results.||participants|||Number
812132|NCT01063036|Secondary|Number of Participants With Emergence of Genotypic Resistance to Study Drugs at Weeks 48 and 96- Treated Population|Testing of HBV genotype was performed at baseline for all treated patients and for participants at Weeks 48 and 96 with primary non-response or virologic breakthrough. Emergent genotypic resistance to study drugs was defined as follows: Emergent = not detected at baseline; entecavir (ETV) resistance (ETVr): participant’s sample was to have rtM204V/I/S and any substitution at rtT184, rtS202, or rtM250; tenofovir (TDF) resistance (TDFr) which was based on adefovir (ADV)-mutations: participant’s sample was to have rtA181T/V, rtN236T, or (rtA194T and rtM204V/I/S). Primary non-response was defined as < 1 log10 decrease in HBV DNA from baseline on treatment at or after Week 12. Virologic breakthrough was defined as ≥ 1 log10 increase in HBV DNA over nadir on treatment, either confirmed or last on-treatment followed by discontinuation of study therapy.|Baseline to Weeks 48, 96|All treated participants who met resistance testing criteria (primary non-response or virologic breakthrough) and were tested for resistance to both study drugs were analyzed. n = number of participants analyzed at Weeks 48 and 96.||participants|||Number
812170|NCT01063348|Secondary|Skin Picking Self Assessment Scale (SP-SAS)|"The entire study for an individual subject will last 12 weeks. Every 3 weeks the subject will take the YBOCS for the duration of the 12 weeks. At each of these visits the outcome will be assessed.
The minimum score is 0 and the maximum score is 48 with higher scores meaning more severe skin picking. The total of all of the questions equals the total reported SP-SAS score."|Once every three weeks for the duration of the 12 week study for each subject|||units on a scale||Standard Deviation|Mean
812133|NCT01063036|Secondary|Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) on Treatment, and Discontinuation of Study Drug Due to Adverse Events (AE) - Treated Population|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. On-treatment = on Day 1 through last dose of study therapy + 5 days.|Day 1 to last dose of study drug plus 5 days; up to Week 96|All Treated participants were analyzed.||participants|||Number
812134|NCT01063036|Secondary|Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion at Weeks 24, 48, and 96 - Treated Population Who Were HBsAg-Positive at Baseline|HBsAg seroconversion was defined as being both HBsAg-negative and HBsAb-positive at Weeks 24, 48, and 96 in those participants who had been HBsAg-positive at baseline. Percentage was calculated as number of participants with HBs seroconversion at Weeks 24 and 48 divided by the number of treated participants who were HBsAg-positive at baseline. Positive result for HBsAg was one of the inclusion criteria. Treated participants (HBsAg positive at baseline) were evaluated using NC=F. The method used was an Immunoassay testing – ADVIA CENTAUR from SIEMENS: in vitro diagnostic immunoassay for the qualitative and quantitative determination of HBsAg in human serum and plasma [potassium ethylenediaminetetraacetic acid (EDTA), lithium or sodium heparinized]. Baseline was Day 1, before start of study drug.|Baseline, Weeks 24, 48, and 96|All treated participants who were HBsAg-positive at baseline and were analyzed at Weeks 24, 48 and 96 (NC = F). An exact binomial 95% confidence interval was constructed.||percentage of participants||95% Confidence Interval|Number
812135|NCT01063036|Secondary|Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 24, 48, 96 - Treated Population Who Were HBsAg-Positive at Baseline|Loss of HBsAg was defined as being HBsAg-negative at Weeks 24, 48, 96 in those participants who had been HBsAg-positive at baseline. The method used: Immunoassay – ADVIA CENTAUR from SIEMENS: in vitro diagnostic immunoassay for the qualitative and quantitative determination of HBsAg in human serum and plasma (potassium ethylene diamine tetraacetic acid, lithium or sodium heparinized). Percentage calculated as number of participants with a HBsAg loss at Weeks 24, 48, and 96 divided by the number of treated participants who were HBsAg-positive at baseline (participants were not enrolled into the study unless they were positive for HBsAg). Treated participants (HBsAg-positive at baseline) were evaluated using NC=F. Baseline was Day 1, before start of study drug.|Baseline, Weeks 24, 48, 96|All treated participants who were HBsAg-positive at baseline and were analyzed at Weeks 24, 48, and 96 (NC = F). An exact binomial 95% Confidence Interval was constructed.||percentage of participants||95% Confidence Interval|Number
812136|NCT01063036|Secondary|Percentage of Participants With HBe Seroconversion at Weeks 24, 48, and 96 - Treated Population Who Were HBeAg-positive at Baseline|HBe seroconversion was defined as being both HBeAg-negative and HBeAb-positive at Weeks 24, 48, and 96 in those participants who had been HBeAg-positive at baseline. Method used was DiaSorin - Anti HBe enzyme immunoassay kit - procedure for qualitative determination of antibodies to HBeAg in human serum or plasma samples. Percentage was calculated as number of participants with HBe seroconversion at Weeks 24, 48, and 96 divided by the number of treated participants who were HBeAg-positive at baseline. Treated participants (HBeAg-positive at baseline) were evaluated using NC = F. Baseline was Day 1, before start of study drug.|Baseline, Weeks 24, 48, and 96|All treated participants who were HBeAg-positive at baseline were analyzed at Weeks 24, 48 and 96 (NC = F). An exact binomial 95% confidence interval was constructed.||percentage of participants||95% Confidence Interval|Number
812137|NCT01063036|Secondary|Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss at Weeks 24, 48, and 96 - Treated Population Who Were HBeAg Positive at Baseline|Loss of HBeAg was defined as being HBeAg-negative at Weeks 24, 48, and 96 in those participants who had been HBeAg-positive at baseline. Method used for HBeAg was DiaSorin - Anti HBe enzyme immunoassay kit – procedure for qualitative determination of antibodies to HBeAg in human serum or plasma samples. Percentage was calculated as number of participants with HBeAg loss at Weeks 24 and 48 divided by the number of treated participants who were HBeAg-positive at baseline. Treated participants (HBeAg-positive at baseline) were evaluated using NC = F. Baseline was Day 1, before start of study drug.|Baseline to Weeks 24, 48, and 96|All treated participants who were HBeAg-positive at baseline were analyzed at Weeks 24, 48 and 96 (NC = F). An exact binomial 95% confidence interval was constructed.||percentage of participants||95% Confidence Interval|Number
812138|NCT01063036|Secondary|Percentage of Participants With HBV DNA Less Than the Lower Limit of Detection (LLD) at Weeks 24, 48, and 96 - Treated Population|HBV DNA less than (<) LLD (6 IU/mL) was defined/measured by the COBAS(REGISTERED) TaqMan HPS assay at Weeks 24, 48, and 96. Percentage was calculated as number of participants with HBV DNA < LLD at Weeks 24, 48, 96 divided by the number of treated participants. Treated participants were evaluated using non-completer (NC) = failure (F).|Weeks 24, 48, 96|All treated participants were analyzed at Weeks 24, 48 and 96 (NC = F). An exact binomial 95% confidence interval was constructed.||percentage of participants||95% Confidence Interval|Number
812139|NCT01063036|Secondary|Change From Baseline in Mean log10 HBV DNA at Weeks 12, 24, 48, and 96 - Treated Evaluable Population|HBV DNA by polymerase chain reaction (PCR) was measured using the Roche COBAS(REGISTERED) TaqMan - High Pure System (HPS) assay. The results were reported in log 10 IU/mL, with the limit of quantification (LOQ) = 29 IU/mL and lower limit of detection (LLD) = 6 IU/mL. HBV DNA measurements were transformed by the log10 scale when analyzed as a continuous variable, using log10(LOQ-1) for values below LOQ. Baseline was Day 1, prior to study drug administration.|Baseline to Weeks 12, 24, 48, 96|All treated participants with results at both baseline and on-treatment were analyzed. n=Number of treated participants with results at baseline and Week 12, Week 24, Week 48 and Week 96.||log10 IU/mL||Standard Deviation|Mean
812171|NCT01063348|Primary|Yale Brown Obsessive Compulsive Scale (YBOCS) Modified for PSP (NE-YBOCS)|"The entire study for an individual subject will last 12 weeks. Every 3 weeks the subject will take the YBOCS for the duration of the 12 weeks. At each of these visits the outcome will be assessed.
The minimum score is 0 and the maximum score is 40, with a higher score being more severe skin picking. There are two sub-scales: one for urges (ranges from 0 to 20) and one for behaviors (ranges from 0 to 20). The total of the scores of each of the sub-scales is the total YBOCS score. That is what will be reported."|Once every three weeks during the 12 week study for each subject|||units on a scale||Standard Deviation|Mean
812140|NCT01063036|Secondary|Percentage of Participants With a Virologic Response at Week 24 and at Week 96 - Treated Population|Virologic response was defined as Hepatitis B virus (HBV) Deoxyribonucleic acid (DNA) less than 50 international units per milliliter (IU/mL); approximately 300 copies/mL. Percentage was calculated as number of participants with virologic response at Week 24, Week 96 divided by the number of treated participants. Treated participants were evaluated using non-completer (NC) = failure (F). The HBV DNA by polymerase chain reaction (PCR) was measured using the Roche COBAS(REGISTERED) TaqMan - High Pure System (HPS) assay. The results were reported in IU/mL, with the limit of quantification (LOQ) = 29 IU/mL and lower limit of detection (LLD) = 6 IU/mL. HBV DNA measurements were transformed by the log10 scale when analyzed as a continuous variable, using log10(LOQ-1) for values below LOQ.|Week 24, Week 96|All treated participants were analyzed at Weeks 24 and 96 (NC = F). An exact binomial 95% confidence interval was constructed.||percentage of participants||95% Confidence Interval|Number
812141|NCT01063036|Primary|Percentage of Participants With a Virologic Response at Week 48 - Treated Population|Virologic response was defined as Hepatitis B virus (HBV) Deoxyribonucleic acid (DNA) less than 50 international units per milliliter (IU/mL); approximately 300 copies/mL. Percentage was calculated as number of participants with virologic response at Week 48 divided by the number of treated participants. Treated participants were evaluated using non-completer (NC) = failure (F). The HBV DNA by polymerase chain reaction (PCR) was measured using the Roche COBAS(REGISTERED) TaqMan - High Pure System (HPS) assay, in a central laboratory. The results were reported in IU/mL, with the limit of quantification (LOQ) = 29 IU/mL and lower limit of detection (LLD) = 6 IU/mL. HBV DNA measurements were transformed by the log10 scale when analyzed as a continuous variable, using log10(LOQ-1) for values below LOQ.|Week 48|All treated participants were analyzed (NC = F). An exact binomial 95% confidence interval was constructed.||percentage of participants||95% Confidence Interval|Number
812142|NCT01063049|Secondary|The Ottawa Scale for Colonoscopy Preparation Will be Reported and Compared Among the 3 Groups to Allow for Comparisons to Some of the Older Literature|Ottawa scale measures colon cleanliness on a scale from 14 (very poor) to 0 (excellent).|After Colonoscopy|||units on a scale||Standard Deviation|Mean
812143|NCT01063049|Primary|The Quality of the Colon Preparation Will be Graded Using the Boston Bowel Preparation Scale|The Boston Bowel Preparation Scale measures cleanliness of the colon on a scale of 0 (very poor) to 9 (excellent).|After Colonoscopy|||units on a scale||Standard Deviation|Mean
812144|NCT01063062|Secondary|Number of Participants With Elevated Triglyceride According to ATPIII Guidelines|Blood samples were collected for Triglyceride and were sent to a central laboratory for analysis. According to Adult Treatment Profile III (ATPIII) guidelines the Triglyceride level in milligram/deciliter (mg/dL) was categorized as: Normal (< 150), Borderline High (150- 199), High (200- 499) or Very High (≥ 500). The number of participants categorized Borderline High, High or Very High at each time-point is reported.|Weeks 0 (Baseline), 4, 8, 12, 16, 20, 24|Safety population included all participants who received study drug and had post-dose safety data available.||participants|||Number
812145|NCT01063062|Secondary|Number of Participants With Elevated LDL Cholesterol According to ATPIII Guidelines|Blood samples were collected for Low Density Lipoprotein (LDL) Cholesterol and were sent to a central laboratory for analysis. According to Adult Treatment Profile III (ATPIII) guidelines the LDL Cholesterol level in milligram/deciliter (mg/dL) was categorized as: Optimal (< 100), Near Optimal/Above Optimal (100- 129), Borderline High (130- 159), High (160-189) or Very High (≥ 190). The number of participants categorized Borderline High, High or Very High at each time-point is reported.|Weeks 0 (Baseline), 4, 8, 12, 16, 20, 24|Safety population included all participants who received study drug and had post-dose safety data available.||participants|||Number
812146|NCT01063062|Secondary|Number of Participants With Elevated HDL Cholesterol According to ATPIII Guidelines|Blood samples were collected for High Density Lipoprotein (HDL) Cholesterol and were sent to a central laboratory for analysis. According to Adult Treatment Profile III (ATPIII) guidelines the HDL Total Cholesterol level in milligram/deciliter (mg/dL) was categorized as: Low (< 40) or High (≥ 60). The number of participants with category High at each time-point is reported.|Weeks 0 (Baseline), 4, 8, 12, 16, 20, 24|Safety population included all participants who received study drug and had post-dose safety data available.||participants|||Number
812147|NCT01063062|Secondary|Number of Participants With Elevated Total Cholesterol According to ATPIII Guidelines|Blood samples were collected for Total Cholesterol and were sent to a central laboratory for analysis. According to Adult Treatment Profile III (ATPIII) guidelines the Total Cholesterol level in milligram/deciliter (mg/dL) was categorized as: Desirable ( < 200), Borderline High (200- 239) or High (≥ 240). The number of participants categorized Borderline High or High at each time-point is reported.|Weeks 0 (Baseline), 4, 8, 12, 16, 20, 24|Safety population included all participants who received study drug and had post-dose safety data available.||participants|||Number
812148|NCT01063062|Secondary|Number of Participants With Elevated AST (SGOT) and ALT (SGPT)|Blood was collected for aspartate aminotransferase (serum glutamic oxaloacetic transaminase) [AST/SGOT] and alanine aminotransferase (serum glutamic pyruvic transaminase) [ALT/SGPT], liver function tests, and were analyzed at a central laboratory. The number of participants with High AST (SGOT) or ALT (SGPT) levels at Week 24 is reported.|Week 24|Participants from the safety population, all participants who received study drug and had at least 1 post-dose safety assessment, with data available for analysis.||participants|||Number
812149|NCT01063062|Secondary|Number of Participants With Serious Infections|A serious infection was an infection that qualified as a Serious Adverse Event (SAE). A SAE was any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.|24 Weeks|Safety population included all participants who received study drug and had post-dose safety data available.||participants|||Number
812172|NCT01063517|Secondary|Time to Deterioration in QoL Anxiety Domain Score in the Overall Study Population|Time calculated from randomisation till worsening of anxiety domain score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data|Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months|Randomised patients having anxiety domain score calculated at baseline and at least one post baseline visit||months||Inter-Quartile Range|Median
831858|NCT01243320|Primary|Change in Chloride Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days|||mmol/L||95% Confidence Interval|Mean
812150|NCT01063062|Secondary|Number of Participants With AE and SAE Related Discontinuation|The number of participants who stopped using the study drug because of an AE or a SAE. An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events. A SAE was any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.|24 Weeks|Safety population included all participants who received study drug and had post-dose safety data available.||participants|||Number
812151|NCT01063062|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events. A SAE was any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.|24 Weeks|Safety population included all participants who received study drug and had post-dose safety data available.||participants|||Number
812152|NCT01063062|Secondary|Erythrocyte Sedimentation Rate (ESR)|Blood was collected for Erythrocyte Sedimentation Rate (ESR), a test to assess inflammation, at Weeks 4, 8, 12, 16, 20, 24 and was analyzed at a central laboratory. ESR was measured in millimeters/hour (mm/hr).|Weeks 4, 8, 12, 16, 20, 24|Participants from the intent-to-treat population, all participants who received study drug and had at least 1 follow-up variable, with data available at the given time point. Last observation carried forward.||mm/hr||Standard Deviation|Mean
812153|NCT01063062|Secondary|C-Reactive Protein (CRP)|Blood was collected for C-Reactive Protein (CRP), a test for inflammation, at Weeks 4, 8, 12, 16, 20 and 24 and was analyzed at a central laboratory. The serum concentration of CRP was measured in milligrams/deciliter (mg/dL).|Weeks 4, 8, 12, 16, 20, 24|Participants from the intent-to-treat population, all participants who received study drug and had data for at least one follow-up variable, with data available for the given timepoint.||mg/L||Standard Deviation|Mean
812154|NCT01063062|Secondary|Disease Activity Score 28 (DAS28)|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Low Disease Activity was defined as a DAS28 score of < 3.2.|Weeks 4, 8, 12, 16, 20, 24|Participants from the intent-to-treat population, all participants who received study drug and had at least 1 follow-up variable, with data available at the given time-point. Last observation carried forward.||score on a scale||Standard Deviation|Mean
812155|NCT01063062|Secondary|Time to DAS28 Remission|Time to DAS28 Remission was the Time in days from the first infusion of study drug to the achievement of a DAS28 score < 2.6 units. The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10.|24 Weeks|Intent-to-treat population included all participants who received study drug and had at least 1 follow-up variable. Last observation carried forward.||days||95% Confidence Interval|Mean
812156|NCT01063062|Secondary|Percentage of Participants Achieving DAS28 Remission|DAS28 Remission was defined as a DAS28 score < 2.6 units. The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10.|Weeks 4, 8, 12, 16, 20, 24|Intent-to-treat population included all participants who received study drug and had at least 1 follow-up variable. Last observation carried forward.||percentage of participants|||Number
812157|NCT01063062|Secondary|Time to DAS28 Clinically Significant Improvement|Time to DAS28 Clinically Significant Improvement was the Time in days from the first infusion of study drug to the achievement of a DAS28 score reduction of at least 1.2 units. The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Low Disease Activity was defined as a DAS28 score of < 3.2.|24 Weeks|Intent-to-treat population included all participants who received study drug and had at least 1 follow-up variable. Last observation carried forward.||days||95% Confidence Interval|Mean
812158|NCT01063062|Secondary|Percentage of Participants Achieving DAS28 Clinically Significant Improvement|DAS28 Clinically Significant Improvement was defined as a DAS28 score reduction of at least 1.2 units from Baseline. The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10.|Baseline, Weeks 4, 8, 12, 16, 20, 24|Intent-to-treat population included all participants who received study drug and had at least 1 follow-up variable. Last observation carried forward.||percentage of participants|||Number
812173|NCT01063517|Secondary|Time to Deterioration in QoL Reflux Domain Score in the Overall Study Population|Time calculated from randomisation till worsening of reflux domain score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data|Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months|Randomised patients having reflux domain score calculated at baseline and at least one post baseline visit||months||Inter-Quartile Range|Median
812159|NCT01063062|Primary|Time to DAS28 Low Disease Activity|Time to DAS28 Low Disease Activity was defined as the time in days from the first infusion of study drug to the achievement of a DAS28 Score <3.2 units. The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Low Disease Activity was defined as a DAS28 score of < 3.2.|24 Weeks|Intent-to-treat population included all participants who received at least one dose of study drug and had data for at least one follow-up variable available. Last observation carried forward.||days||95% Confidence Interval|Mean
812160|NCT01063062|Primary|Percentage of Participants Achieving Disease Activity Score 28 (DAS28) Low Disease Activity|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Low Disease Activity was defined as a DAS28 score of < 3.2.|Baseline to Week 24 (Weeks 4, 8, 12, 16, 20, 24)|Intent-to-treat (ITT) population included all participants who received study drug and had at least 1 follow-up variable. Last observation carried forward was applied for missing data.||percentage of participants|||Number
812161|NCT01063075|Primary|Cetuximab PK: Confirmatory Serum Concentration||Group D: Prior to Carboplatin Infusion, Cycle 1, Day 1|All participants who received at least one dose of study drug who were enrolled in Group D and had evaluable PK data. Study design by intent did not collect data from Groups A, B, and C.||micrograms per milliliters (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
812162|NCT01063075|Primary|Cetuximab PK: Time of Maximum Observed Plasma Concentration at Steady State (Tmax,ss)||(Group B: Cycle 1 and Cycle 2+ ; Day 1, 8, 15 and Group C: Cycle 1, Day 8, 15 and 22; Cycle 2+, Day 1,8 and 15): Prior to Cetuximab Infusion, 1 Hour (H), 2 H, 4 H, 8 H, 24 H, 72 H, 120 H, and 168 H (after the start of Cetuximab Infusion)|All participants who received at least one dose of study drug who were enrolled in Group B and C and had evaluable PK data. Study design by intent did not collect data from Groups D and A.||Hour (h)||Full Range|Median
812163|NCT01063075|Primary|Total Carboplatin PK: Time of Maximum Observed Plasma Concentration (Tmax)||Group D: Cycle 1, Week 1, Day 1; Prior to Carboplatin Infusion, 1hour (H), 1:30 H, 2 H, 3 H, 5 H, 8 H, 24 H, 72 H (after the Start of Carboplatin Infusion)|Participants who received at least 1 dose of study drug who were enrolled in Group(Grp)D & had evaluable PK data.Study design by intent did not collect data from Grp B.Due to participant recruitment & retention challenges,there were no PK study completers for Grp A & C.Participant recruitment & retention addressed by amending protocol to add Grp D.||Hour (h)||Full Range|Median
812164|NCT01063075|Primary|Cetuximab PK: Maximum Observed Plasma Concentration at Steady State (Cmax,ss)||(Group B: Cycle 1 and Cycle 2+ ; Day 1, 8, 15 and Group C: Cycle 1, Day 8, 15 and 22; Cycle 2+, Day 1,8 and 15): Prior to Cetuximab Infusion, 1 Hour (H), 2 H, 4 H, 8 H, 24 H, 72 H, 120 H, and 168 H (after the start of Cetuximab Infusion)|All participants who received at least one dose of study drug who were enrolled in Group B and C and had evaluable PK data. Study design by intent did not collect data from Groups D and A.||micrograms per milliliters (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
812165|NCT01063075|Primary|Total Carboplatin PK: Maximum Observed Plasma Concentration (Cmax)||Group D: Cycle 1, Week 1, Day 1; Prior to Carboplatin Infusion, 1hour (H), 1:30 H, 2 H, 3 H, 5 H, 8 H, 24 H, 72 H (after the Start of Carboplatin Infusion)|Participants who received at least 1 dose of study drug who were enrolled in Group(Grp)D & had evaluable PK data.Study design by intent did not collect data from Grp B.Due to participant recruitment & retention challenges,there were no PK study completers for Grp A & C.Participant recruitment & retention addressed by amending protocol to add Grp D.||micrograms per milliliters (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
812166|NCT01063075|Primary|Cetuximab PK: Area Under the Concentration Versus Time Curve During One Dosing Interval at Steady State (AUC τ,ss)||(Group B: Cycle 1 and Cycle 2+ ; Day 1, 8, 15 and Group C: Cycle 1, Day 8, 15 and 22; Cycle 2+, Day 1,8 and 15): Prior to Cetuximab Infusion, 1 Hour (H), 2 H, 4 H, 8 H, 24 H, 72 H, 120 H, and 168 H (after the start of Cetuximab Infusion)|All participants who received at least one dose of study drug who were enrolled in Group B and C and had evaluable PK data. Study design by intent did not collect data from Groups D and A.||micrograms*hour/milliliters (μg•h/mL)||Geometric Coefficient of Variation|Geometric Mean
812167|NCT01063075|Primary|Total Carboplatin Pharmacokinetics (PK): Area Under the Concentration (AUC) Versus Time Curve From Time Zero to Infinity (AUC[0-∞])||Group D: Cycle 1, Week 1, Day 1; Prior to Carboplatin Infusion, 1hour (H), 1:30 H, 2 H, 3 H, 5 H, 8 H, 24 H, 72 H (after the Start of Carboplatin Infusion)|Participants who received at least 1 dose of study drug who were enrolled in Group(Grp)D & had evaluable PK data.Study design by intent did not collect data from Grp B.Due to participant recruitment & retention challenges,there were no PK study completers for Grp A & C.Participant recruitment & retention addressed by amending protocol to add Grp D.||micrograms*hour/milliliters (μg•h/mL)||Geometric Coefficient of Variation|Geometric Mean
812168|NCT01063153|Primary|Percent Errors in Visual Go/NoGo Task|The Go/NoGo visual task was completed by subjects with ADHD as well as healthy controls. The Go/NoGo task is used to assess inhibitory control, and targets response inhibition, executive functions, and sustained attention. The 'Go' stimulus occupies 80% of the trials, and requires the subject to perform a motor response each time it appears on the screen. A rare 'No Go' stimulus (occupies 20% of all trials) requires the subject to refrain from responding. The percentage of errors were measured for each group.|Single Point (Baseline)|Only subjects that met the a priori pre-defined EEG signal quality criteria were included.||percentage of errors|||Number
812169|NCT01063153|Primary|Adult ADHD Investigator Symptom Rating Scale (AISRS)|An 18-item scale rating a subject's level of impairment from 0 (none) to 3 (severe) for each symptom of DSM-IV ADHD, with a maximum possible score of 54. The measure was collected at Baseline and 6 weeks, and a total score was calculated to gauge treatment response of ADHD subjects to open-label Concerta.|Baseline and 6 weeks|Subjects in the ADHD group who completed all 6 weeks of the trial were included in data analysis. Subjects who completed at least 3 weeks of treatment were also included regardless of the reason for withdrawal, and final-visit AISRS scores were used in ITT (intent-to-treat) analysis via last observation carried forward [LOCF] imputation.||units on a scale||Standard Deviation|Mean
812174|NCT01063517|Secondary|Time to Deterioration in QoL Stomach Pain Domain Score in the Overall Study Population|Time calculated from randomisation till worsening of stomach pain domain score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data|Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months|Randomised patients having stomach pain domain score calculated at baseline and at least one post baseline visit||months||Inter-Quartile Range|Median
812175|NCT01063517|Secondary|Time to Deterioration in QoL Eating Restriction Domain Score in the Overall Study Population|Time calculated from randomisation till worsening of eating restriction domain score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data|Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months|Randomised patients having eating restriction domain score calculated at baseline and at least one post baseline visit||months||Inter-Quartile Range|Median
812176|NCT01063517|Secondary|Time to Deterioration in QoL Dysphagia Domain Score in the Overall Study Population|Time calculated from randomisation till worsening of dysphagia domain score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data|Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months|Randomised patients having dysphagia domain score calculated at baseline and at least one post baseline visit||months||Inter-Quartile Range|Median
812177|NCT01063517|Secondary|Time to Deterioration in QoL Pain Domain Score in the Overall Study Population|Time calculated from randomisation till worsening of pain domain score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data|Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months|Randomised patients having pain domain score calculated at baseline and at least one post baseline visit||months||Inter-Quartile Range|Median
812178|NCT01063517|Secondary|Time to Deterioration in QoL Nausea & Vomiting Domain Score in the Overall Study Population|Time calculated from randomisation till worsening of nausea & vomiting domain score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data|Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months|Randomised patients having nausea & vomiting domain score calculated at baseline and at least one post baseline visit||months||Inter-Quartile Range|Median
812179|NCT01063517|Secondary|Time to Deterioration in QoL Fatigue Score in the Overall Study Population|Time calculated from randomisation till worsening of fatigue score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data|Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months|Randomised patients having fatigue score calculated at baseline and at least one post baseline visit||months||Inter-Quartile Range|Median
812180|NCT01063517|Secondary|Time to Deterioration in Global Quality of Life (QoL) Score in the Overall Study Population|Time calculated from randomisation till worsening of Global QoL score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data|Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months|Randomised patients having global score calculated at baseline and at least one post baseline visit||months||Inter-Quartile Range|Median
812181|NCT01063517|Secondary|Percentage Change in Tumour Size at Week 8 in the ATM Negative Patients|Percentage change in tumour size from baseline to Week 8 calculated as 100 X (week 8 tumour size - baseline tumour size) / (baseline tumour size)|Tumour scans done at Baseline and week 8|Evaluable for response population ATM negative patients - randomised ATM negative patients having measurable disease at baseline.||Percent change||Standard Deviation|Mean
812182|NCT01063517|Secondary|Percentage Change in Tumour Size at Week 8 in the Overall Study Population|Percentage change in tumour size from baseline to Week 8 calculated as 100 X (week 8 tumour size - baseline tumour size) / (baseline tumour size)|Tumour scans done at Baseline and week 8|Evaluable for response population - randomised patients having measurable disease at baseline.||Percent change||Standard Deviation|Mean
812183|NCT01063517|Secondary|Objective Response Rate (ORR) in the ATM Negative Patients|Objective response rate is the proportion of ATM negative patients with at least one measurable lesion at baseline, who experienced complete or partial response at least once during the assessment period, according to the definitions of Response Evaluation Criteria In Solid Tumours (RECIST version 1.1).|Tumour assessments carried out at baseline, 28 days before randomisation then every 8 weeks until week 40, after week 40 assessments will be carried out every 16 weeks until objective disease progression, assessed maximum up to 27 months|Evaluable for response population ATM negative patients - randomised ATM negative patients having measurable disease at baseline.||Participants|||Number
812184|NCT01063517|Secondary|Objective Response Rate (ORR) in the Overall Study Population|Objective response rate is the proportion of patients with at least one measurable lesion at baseline, who experienced complete or partial response at least once during the assessment period, according to the definitions of Response Evaluation Criteria In Solid Tumours (RECIST version 1.1).|Tumour assessments carried out at baseline, 28 days before randomisation then every 8 weeks until week 40, after week 40 assessments will be carried out every 16 weeks until objective disease progression, assessed maximum up to 27 months|Evaluable for response population - randomised patients having measurable disease at baseline.||Participants|||Number
812185|NCT01063517|Secondary|Overall Survival (OS) in ATM Negative Patients|Overall survival is defined as the duration from randomisation till death. In absence of death, the time is calculated from randomisation till the date subject last known to be alive.|Survival follow up from randomisation till death of the patient or till end of study in absence of death, assessed maximum up to 27 months|Full analysis set including randomised ATM negative patients||months||Inter-Quartile Range|Median
812186|NCT01063517|Secondary|Overall Survival (OS) in the Overall Study Population|Overall survival is defined as the duration from randomisation till death. In absence of death, the time is calculated from randomisation till the date subject last known to be alive.|Survival follow up from randomisation till death of the patient or till end of study in absence of death, assessed maximum up to 27 months|Full analysis set including all randomised patients||months||Inter-Quartile Range|Median
831859|NCT01243320|Primary|Change in Potassium Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days|||mmol/L||95% Confidence Interval|Mean
812187|NCT01063517|Primary|Progression Free Survival (PFS) in Patients With Tumours Defined as Homologous Recombination Deficient by Loss of Ataxia-Telangiectasia Mutation (ATM) Protein [ATM Negative Patients]|PFS is defined as the time from randomisation till objective progression or death. In absence of progression or death, the time is calculated from randomisation till last evaluable scanning visit.|Tumour assessments are carried out at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed maximum up to 27 months|Full analysis set including randomised ATM negative patients||months||Inter-Quartile Range|Median
812188|NCT01063517|Primary|Progression Free Survival (PFS) in the Overall Study Population|PFS is defined as the time from randomisation till objective progression or death. In absence of progression or death, the time is calculated from randomisation till last evaluable scanning visit.|Tumour assessments were carried out at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed maximum up to 27 months|Full analysis set including all randomised patients||months||Inter-Quartile Range|Median
812189|NCT01063595|Secondary|Concentration of Plasmin Inhibitor|Values of plasmin inhibitor were measured by validated assays from blood samples obtained 30 minutes before plasmapheresis, 5 minutes after the end of plasmapheresis, 15 minutes and 2 hours after the end of study drug administration, and 24 hours and 7 days after initiation of plasmapheresis. The concentration of plasmin inhibitor is reported as the percentage of plasmin inhibition. A higher concentration of plasmin inhibitor results in a higher percentage of plasmin inhibition.|From 30 minutes before plasmapheresis up to 24 hours after the end of plasmapheresis|Per protocol population: All participants who had evaluable efficacy measurements in both of the treatment periods.||Percentage inhibition||Standard Deviation|Mean
812190|NCT01063595|Primary|Recovery of the Haemostatic Parameters Prothrombin Time, Activated Partial Thromboplastin Time, and Protein C|Recovery was defined as the maximum (minimum for activated partial thromboplastin time) percentage change of the haemostatic parameter value measured 5 minutes after the end of plasmapheresis to the haemostatic parameter value measured at 15 minutes or 2 hours after the end of study drug administration. The haemostatic parameters were measured by validated assays from blood samples obtained 5 minutes after the end of plasmapheresis and 15 minutes and 2 hours after the end of study drug administration.|From 5 minutes after the end of plasmapheresis up to 2 hours after the end of study drug administration|Per protocol population: All participants who had evaluable efficacy measurements in both of the treatment periods.||Percentage change||Standard Deviation|Mean
812191|NCT01063595|Primary|Recovery of the Coagulation Factors I, II, V, VII, VIII, IX, X, and XI|Recovery was defined as the maximum percentage change of the coagulation factor value measured 5 minutes after the end of plasmapheresis to the coagulation factor value measured at 15 minutes or 2 hours after the end of study drug administration. The coagulation parameters were measured by validated assays from blood samples obtained 5 minutes after the end of plasmapheresis and 15 minutes and 2 hours after the end of study drug administration.|From 5 minutes after the end of plasmapheresis up to 2 hours after the end of study drug administration|Per protocol population: All participants who had evaluable efficacy measurements in both of the treatment periods.||Percentage change||Standard Deviation|Mean
812192|NCT01063712|Secondary|Number of Patients With a Decreased Dilation of the Left Heart Chamber (Time Frame: One Year After Treatment). Dilation of the Left Ventricle and Left Atrium Was Measured Before and One Year After Implantation by Echocardiography.|The patients were examined clinically and echocardiographically after 24 hours, one month, three months and six months after the percutaneous closure. Dilation of the left ventricle and left atrium are consequences of the hyperflow through the ducts. Regression of both ventricle and atrium are expected after closure of the ducts and can be documented by echocardiography. Additionally, the position of the device and the doppler flow in the descending aorta and left pulmonary artery were documented.|one year after percutaneous closure|"The patient selection was based in the consecutive case and intention to treat method. All patients recruited in the determinated time frame (June 2009 to May 2010) who met the initial inclusion criteria were treated in the catheterisation laboratory. There the definite inclusion criteria were applied."||participants|||Number
812193|NCT01063712|Primary|Number of Patients With a Closed Patent Ductus Arteriosus (Defect) Determinated by Echocardiography ( Time Frame: One Year After Treatment)|The closure rate is an effectiveness outcome. Complete closure without a residual shunt is defined as absence of color flow (an echocardiographic technique used to observe the flow of blood in the heart) between the aorta and the pulmonary artery through the duct. Additionally, the position of the device, regression of the dilation of the left ventricle and left atrium and assessing of unrestricted doppler flow in the descending aorta and left pulmonary artery were documented. Clinical status was also assessed.|up to one year after percutaneous closure|"29 patients were controled in a period of one year and were examinated by echocardiography.The number of patients who showed no more duct bloodflow (seen with color doppler echocardiography or color flow) in the control period is given as number and as percentage of the complete group."||Participants|||Number
812194|NCT01063764|Secondary|Change From Baseline in Partial Seizure Frequency Per Week for the Second Period (up to Three Years From Informed Consent Until the Time of Approval Granted)|"The outcome was also calculated for each 3-month Period but here only the result for the total Second Evaluation Period (Second Period without following 6-weeks Withdrawal Period for withdrawers) is presented.
Change in partial seizure frequency from Baseline (B) over Second Evaluation Period (E) is given as a percentage reduction computed as:
(B values- E values) / B values x 100. Positive values in percent reduction show a decrease from Baseline. Frequency per week of partial seizures = (Total number of partial seizures in a certain Period/number of observation days in the Period) x 7."|From Baseline (Week 0-8) until the time of approval granted (up to three years from date of informed consent (Week 0); without 6-weeks Withdrawal Period)|Full Analysis Set (FAS).||Percent reduction||Inter-Quartile Range|Median
812195|NCT01063764|Secondary|Incidence of Treatment-emergent Adverse Drug Reactions (ADRs) During the Second Period (up to Three Years Until the Time of Approval Granted)|An Adverse Drug Reaction (ADR) is an Adverse Event for which a causal relationship between the product and the occurrence is suspected. Incidence of ADRs is reported by the number of subjects with at least one ADR.|During the second Period from Visit 8 (Week 22) to the end of the Follow-up Period (up to three years until the time of approval granted)|Full Analysis Set (FAS).||participants|||Number
812198|NCT01063764|Secondary|Percentage of Partial Seizures 50 % Responders Over the 10-weeks Evaluation Period|"50 % responders are those subjects which have a 50 % or more reduction in the frequency of partial seizures from Baseline to the Evaluation Period. The results show the percentage of participants that are 50 % responders.
Partial seizures can be classified into one of the following three groups:
Simple partial seizures
Complex partial seizures
Partial seizures evolving to secondarily generalized seizures."|10-weeks Evaluation Period (Part of the first Period: Week 12 to Week 22)|Of the 73 subjects in the FAS, 68 subjects had available data over the Evaluation Period.||percentage of participants||95% Confidence Interval|Number
812199|NCT01063764|Secondary|Percentage of Partial Seizures 50 % Responders Over the 14-weeks Treatment Period|"50 % responders are those subjects which have a 50 % or more reduction in the frequency of partial seizures from Baseline to the Treatment Period. The results show the percentage of participants that are 50 % responders.
Partial seizures can be classified into one of the following three groups:
Simple partial seizures
Complex partial seizures
Partial seizures evolving to secondarily generalized seizures."|14-weeks Treatment Period (First Period: 4 weeks Up-titration (Week 8-12) and 10 weeks Evaluation (Week 12-22))|Full Analysis Set (FAS).||percentage of participants||95% Confidence Interval|Number
812200|NCT01063764|Secondary|Partial Seizure Frequency Per Week Over the 10-weeks Evaluation Period|"The seizure frequency per week was calculated as:
Frequency per week of partial seizures = (Total number of partial seizures in the Evaluation Period/number of days for observation in the Evaluation Period) x 7. Partial seizures can be classified into one of the following three groups:
Simple partial seizures
Complex partial seizures
Partial seizures evolving to secondarily generalized seizures."|10-weeks Evaluation Period (Part of the first Period: Week 12 to Week 22)|Full Analysis Set (FAS). Only subjects having values unequal to zero over Baseline and values equal to or greater than zero over Treatment Period are included.||Seizures per week||Inter-Quartile Range|Median
812201|NCT01063764|Secondary|Partial Seizure Frequency Per Week Over the 14-weeks Treatment Period|"The seizure frequency per week was calculated as:
Frequency per week of partial seizures = (Total number of partial seizures in the Treatment Period/number of days for observation in the Treatment Period) x 7. Partial seizures can be classified into one of the following three groups:
Simple partial seizures
Complex partial seizures
Partial seizures evolving to secondarily generalized seizures."|14-weeks Treatment Period (First Period: 4 weeks Up-titration (Week 8-12) and 10 weeks Evaluation (Week 12-22))|Full Analysis Set (FAS). Only subjects having values unequal to zero over Baseline and values equal to or greater than zero over Treatment Period are included.||Seizures per week||Inter-Quartile Range|Median
812202|NCT01063764|Secondary|Change From Baseline in Partial Seizure Frequency Per Week Over the 10-week Evaluation Period|"The change in partial seizure frequency from Baseline (B) over the Evaluation Period (E) is given as a percentage reduction computed as:
(B values- E values) / B values x 100. Positive values in percent reduction mean that the value decreased from Baseline to the 10-week Evaluation Period.
Frequency per week of partial seizures = (Total number of partial seizures in a certain Period/number of observation days in the Period) x 7.
Partial seizures can be classified into:
Simple partial seizures
Complex partial seizures
Partial seizures evolving to secondarily generalized seizures."|From Baseline (Week 0-8) to the 10-weeks Evaluation Period (Part of the first Period: Week 12 to Week 22)|Of the 73 subjects in the FAS, 68 subjects had available data at Baseline and during the Evaluation Period.||Percent reduction||95% Confidence Interval|Median
812203|NCT01063764|Primary|Incidence of Treatment-Emergent Adverse Events (TEAEs) During the Second Period (up to Three Years Until the Time of Approval Granted)|An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with the pharmaceutical product. Incidence of treatment-emergent AEs is reported by the percentage of subjects with at least one treatment-emergent AE.|During the second Period from Visit 8 (Week 22) to the end of the Follow-up Period (up to three years until the time of approval granted)|Full Analysis Set (FAS).||percentage of participants|||Number
812204|NCT01063764|Primary|Change From Baseline in Partial Seizure Frequency Per Week Over the 14-weeks Treatment Period|"The change in partial seizure frequency from Baseline (B) over the Treatment Period (T) is given as a percentage reduction computed as:
(B values- T values) / B values x 100.
Positive values in percent reduction mean that the value decreased from Baseline during the first 14-week Period.
Frequency per week of partial seizures = (Total number of partial seizures in a certain Period/number of observation days in the Period) x 7.
Partial seizures can be classified into:
Simple partial seizures
Complex partial seizures
Partial seizures evolving to secondarily generalized seizures."|From Baseline (Week 0-8) to the 14-weeks Treatment Period (First Period: 4 weeks Up-titration (Week 8-12) and 10 weeks Evaluation (Week 12-22)); Week 0-22|Full Analysis Set (FAS).||Percent reduction||95% Confidence Interval|Median
812205|NCT01063855|Secondary|"The Percentage of Patients Reporting At Least a Slightly Better Response to Treatment"|"The Clinical Global Impression of Change (CGIC) was used to assess the degree of improvement the patient experienced with premature ejaculation (PE) since initiating treatment with study drug on a 7-point scale from Much worse, Worse, Slightly worse, No change, Slightly better, Better, to Much better”. The percentage of patients who reported improvement in PE of at least slightly better at Endpoint (after 12 weeks of treatment) is provided in the table below."|Endpoint (After 12 weeks of treatment)|The intent-to-treat (ITT) analysis set included all randomized patients. Missing efficacy data at Week 12 was imputed based on the last postbaseline observation carried forward (LPOCF) method.||Percentage of Patients|||Number
812206|NCT01063855|Secondary|The Percentage of Patients Who Reported At Least a 1-category Decrease (Improvement) in Interpersonal Difficulty Related to Ejaculation|"The Premature Ejaculation Profile (PEP), a patient-reported outcome measure was used to rate the patient's level of interpersonal difficulty related to ejaculation on a 5-point scale from Very poor, Poor, Fair, Good, to Very Good. The percentage of patients who reported at least a 1-category decrease (improvement) in interpersonal difficulty related to ejaculation is provided in the table below."|Endpoint (After 12 weeks of treatment)|The intent-to-treat (ITT) analysis set included all randomized patients. Missing efficacy data at Week 12 was imputed based on the last postbaseline observation carried forward (LPOCF) method.||Percentage of Patients|||Number
812293|NCT01064622|Primary|Progression-free Survival|Time from randomization to disease progression or death from any cause. Estimated in the two treatment groups by the Kaplan-Meier method and compared using a stratified logrank test.|Up to 3 years|Phase I lead-in patients were not included in the efficacy analysis.||months||95% Confidence Interval|Median
812207|NCT01063855|Secondary|"The Percentage of Patients Reporting At Least a Better Response to Treatment"|"The Clinical Global Impression of Change (CGIC) was used to assess the degree of improvement the patient experienced with premature ejaculation (PE) since initiating treatment with study drug on a 7-point scale from Much worse, Worse, Slightly worse, No change, Slightly better, Better, to Much better”. The percentage of patients who reported improvement in PE of at least better at Endpoint (after 12 weeks of treatment) is provided in the table below."|Endpoint (After 12 weeks of treatment)|The intent-to-treat (ITT) analysis set included all randomized patients. Missing efficacy data at Week 12 was imputed based on the last postbaseline observation carried forward (LPOCF) method.||Percentage of Patients|||Number
812208|NCT01063855|Secondary|The Percentage of Patients Who Achieved a 1-category or Greater Increase in Satisfaction With Sexual Intercourse|"The Premature Ejaculation Profile (PEP), a patient-reported outcome measure was used to rate the patient's level of satisfaction with intercourse on a 5-point scale from Very poor, Poor, Fair, Good, to Very Good. The percentage of patients who achieved 1-category or greater increase in satisfaction with sexual intercourse is provided in the table below."|Endpoint (After 12 weeks of treatment)|The intent-to-treat (ITT) analysis set included all randomized patients. Missing efficacy data at Week 12 was imputed based on the last postbaseline observation carried forward (LPOCF) method.||Percentage of Patients|||Number
812209|NCT01063855|Secondary|The Percentage of Patients Reporting a Composite Score of At Least a 2-category Increase in Control Over Ejaculation and At Least a 1-category Decrease in Personal Distress|"The Premature Ejaculation Profile (PEP), a patient-reported outcome measure was used to rate the patient's level of distress related to the speed of ejaculation and control over ejaculation on a 5-point scale from Very poor, Poor, Fair, Good, to Very Good. The percentage of patients who reported a composite score of at least a 2-category increase in control over ejaculation and at least a 1-category decrease (improvement) in personal distress is provided in the table below."|At the end of treatment (Week 12)|The intent-to-treat (ITT) analysis set included all randomized patients. Missing efficacy data at Week 12 was imputed based on the last postbaseline observation carried forward (LPOCF) method.||Percentage of Patients|||Number
812210|NCT01063855|Secondary|The Percentage of Patients Who Achieved 1-category or Greater Decrease (Improvement) in Personal Distress Related to Ejaculation|"The Premature Ejaculation Profile (PEP), a patient-reported outcome measure was used to rate the patient's level of distress related to the speed of ejaculation on a 5-point scale from Very poor, Poor, Fair, Good, to Very Good. The percentage of patients who achieved 1-category or greater decrease (improvement) in personal distress related to the speed of ejaculation is provided in the table below."|At Endpoint (After 12 weeks of treatment)|The intent-to-treat (ITT) analysis set included all randomized patients. Missing efficacy data at Week 12 was imputed based on the last postbaseline observation carried forward (LPOCF) method.||Percentage of Patients|||Number
812211|NCT01063855|Secondary|The Percentage of Patients Reporting At Least a 2-category Increase in Control Over Ejaculation|"The Premature Ejaculation Profile (PEP), a patient-reported outcome measure was used to rate the patient's control over ejaculation on a 5-point scale from Very poor, Poor, Fair, Good, to Very Good. The percentage of patients who reported at least a 2-category increase in control over ejaculation is provided in the table below."|At the end of treatment (Week 12)|The intent-to-treat (ITT) analysis set included all randomized patients. Missing efficacy data at Week 12 was imputed based on the last postbaseline observation carried forward (LPOCF) method.||Percentage of Patients|||Number
812212|NCT01063855|Primary|The Average Intravaginal Ejaculatory Latency Time (IELT) at Week 12|The intravaginal ejaculatory latency time (IELT) is the time it takes for a man to ejaculate during sexual intercourse (as measured by stopwatch). The data below show the average IELT measured in minutes at Baseline (before treatment) to Endpoint (after 12 weeks of treatment). In this study, patients took placebo or dapoxetine along with a stable dose of a phosphodiesterase-5 inhibitor (PDE5I) prescribed prior to study entry for the treatment of erectile dysfunction.|Baseline, Week 12|The intent-to-treat (ITT) analysis set included all randomized patients. Missing efficacy data at Week 12 was imputed based on the last postbaseline observation carried forward (LPOCF) method.||minutes||Standard Deviation|Mean
812213|NCT01063868|Primary|Number of Subjects With Treatment-emergent Adverse Events (TEAE)|The number of participants who reported a TEAE during the treatment period. TEAE was defined as any adverse event that started or worsened on or after the start of the study medication and up to 3 days after the discontinuation of the study medication.|Entire Study|Safety analysis set (All randomized participants who took at least one dose of study medication).||participants|||Number
812214|NCT01063881|Secondary|"The Number of Patients Who Described Their Premature Ejaculation (PE) as At Least Slightly Better in Response to Dapoxetine Treatment (Subgroups by Intravaginal Ejaculation Latency Time [IELT])"|"The Clinical Global Impression of Change (CGIC) was used to assess the patient's improvement with premature ejaculation (PE) since initiating treatment with dapoxetine. The data provided below represent the number of patients who reported at least a slightly better response to treatment when grouped by intravaginal ejaculation latency time (patients with an IELT of < 1 minute and patients with an IELT of > 1 minute). This was a single-arm, open-label, non-randomized study where patients were categorized based on IELT after enrollment in the study."|Week 12|The full analysis set (FAS) included all patients who took at least one dose of study drug and completed at least one assessment of efficacy.||Patients|||Number
812215|NCT01063881|Secondary|"The Number of Patients Who Described Their Premature Ejaculation (PE) as At Least Slightly Better in Response to Dapoxetine Treatment (Subgroups by Disease Type)"|"The Clinical Global Impression of Change (CGIC) was used to assess the patient's improvement with premature ejaculation (PE) since initiating treatment with dapoxetine. The data provided below represent the number of patients who reported at least a slightly better response to treatment when grouped by type of PE disease (patients with life-long PE and patients with acquired PE). This was a single-arm, open-label, non-randomized study where patients were categorized based their PE disease after enrollment in the study."|Week 12|The full analysis set (FAS) included all patients who took at least one dose of study drug and completed at least one assessment of efficacy.||Patients|||Number
812477|NCT01070810|Secondary|APACHE II Score at 24 Hours|"APACHE II (Acute Physiology and Chronic Health Evaluation II) is a severity-of-disease classification system; an integer score from 0 to 71 is computed based on several measurements; higher scores correspond to more severe disease and a higher risk of death"|24 hours|APACHE II was not available on 6 patients in each group at 24 hour mostly because of early death.||units on a scale||Standard Deviation|Mean
812216|NCT01063881|Secondary|"The Number of Patients Who Described Their Premature Ejaculation (PE) as At Least Slightly Better in Response to Dapoxetine Treatment (Subgroups by Dosage)"|"The Clinical Global Impression of Change (CGIC) was used to assess the patient's improvement with premature ejaculation (PE) since initiating treatment with dapoxetine. The data provided below represent the number of patients who reported at least a slightly better response to treatment by the dose of dapoxetine they received in the study. This was a single-arm, open-label, non-randomized study in which “subgroup by dosage” was categorized based on dose-titration patterns observed during the course of the treatment period."|Week 12|The full analysis set (FAS) included all patients who took at least one dose of study drug and completed at least one assessment of efficacy.||Patients|||Number
812217|NCT01063881|Secondary|Patient Responses to Improvement With Their Premature Ejaculation After 12 Weeks of Treatment With Dapoxetine|"The Clinical Global Impression of Change (CGIC), a patient-reported scale was used to assess the patient's improvement with premature ejaculation (PE) since initiating treatment with dapoxetine. Patients were asked: Compared to the start of the study, would you describe your premature ejaculation (PE) problem as: Much worse, Worse, Slightly worse, No change, Slightly better, Better, or Much better?” The number of patients reporting improvement in their PE by category of the CGIC scale after 12 weeks of treatment with dapoxetine are provided in the table below."|Week 12|The full analysis set (FAS) included all patients who took at least one dose of study drug and completed at least one assessment of efficacy.||Patients|||Number
812218|NCT01063881|Secondary|The Patient's Degree of Interpersonal Difficulty Related to the Speed of Ejaculation|"The Premature Ejaculation Profile (PEP), a patient-reported outcome measure was used to rate the patient's level of interpersonal difficulty related to the speed of ejaculation. Patient's were asked: Over the past month, to what extent did how fast you/your partner ejaculated during sexual intercourse cause difficulty in your relationship with your partner? Not at all, A little bit, Moderately, Quite a bit, or Extremely? The number of patients who rated their level of interpersonal difficulty before treatment and after 12 weeks of treatment with dapoxetine are provided in the table below."|Baseline and Week 12|The full analysis set (FAS) included all patients who took at least one dose of study drug and completed at least one assessment of efficacy.||Patients|||Number
812219|NCT01063881|Secondary|The Patient's Level of Personal Distress Related to the Speed of Ejaculation|"The Premature Ejaculation Profile (PEP), a patient-reported outcome measure was used to rate the patient's level of distress related to the speed of ejaculation. Patient's were asked: Over the past month, how distressed were you by how fast you ejaculated during sexual intercourse? Not at all, A little bit, Moderately, Quite a bit, Extremely. The number of patients who rated their level of personal distress related to the speed of ejaculation before treatment and after 12 weeks of treatment with dapoxetine are provided in the table below."|Baseline and Week 12|The full analysis set (FAS) included all patients who took at least one dose of study drug and completed at least one assessment of efficacy.||Patients|||Number
812220|NCT01063881|Secondary|The Patient's Level of Satisfaction With Intercourse|"The Premature Ejaculation Profile (PEP), a patient-reported outcome measure was used to rate the patient's level of satisfaction with intercourse on a 5-point scale. Patients were asked: Over the past month, was your satisfaction with sexual intercourse Very poor, Poor, Fair, Good, or Very Good?” The number of patients who rated their level of satisfaction with control over ejaculation at before treatment and after 12 weeks of treatment with dapoxetine are provided in the table below."|Baseline and Week 12|The full analysis set (FAS) included all patients who took at least one dose of study drug and completed at least one assessment of efficacy.||Patients|||Number
812221|NCT01063881|Secondary|The Patient's Level of Control Over Ejaculation|"The Premature Ejaculation Profile (PEP), a patient-reported outcome measure was used to rate the patient's level of control over intercourse on a 5-point scale. Patients were asked: Over the past month, was your level of control over ejaculation Very poor, Poor, Fair, Good, or Very Good?” The number of patients who rated their level of control over ejaculation before treatment and after 12 weeks of treatment with dapoxetine are provided in the table below."|Baseline and Week 12|The full analysis set (FAS) included all patients who took at least one dose of study drug and completed at least one assessment of efficacy.||Patients|||Number
812222|NCT01063881|Primary|"The Number of Patients Who Described Their Premature Ejaculation (PE) as At Least Slightly Better in Response to Dapoxetine Treatment"|"The Clinical Global Impression of Change (CGIC), a patient-reported scale was used to assess the patient's improvement with premature ejaculation (PE) since initiating treatment with dapoxetine. Patients were asked: Compared to the start of the study, would you describe your premature ejaculation (PE) problem as: Much worse, Worse, Slightly worse, No change, Slightly better, Better, or Much better?” The number of patients who described improvement with their PE of at least slightly better after 12 weeks of treatment with dapoxetine are provided in the table below."|Week 12|The full analysis set (FAS) included all patients who took at least one dose of study drug and completed at least one assessment of efficacy.||Patients|||Number
812223|NCT01063907|Secondary|Phase 1: PK Elimination t½ hr Day 11|Descriptive summary statistics (number, arithmetic mean, standard deviation [SDev], coefficient of variation [CV%]) for concentration and PK data for KW-2478 and Bortezomib in Phase 1 were presented by cohort, dose level and day.|PK collected Day 11 of 21-day cycle|The PK of KW-2478 was characterized after single administrations through @25 hours post start of infusion dose on Day 1 and through @7 hours post start of infusion dose on Day 11in Phase 1 only.||hr||Standard Deviation|Mean
812224|NCT01063907|Secondary|Phase 1: PK Exposure AUC0-t hr*ng/mL Day 11|Descriptive summary statistics (number, arithmetic mean, standard deviation [SDev], coefficient of variation [CV%]) for concentration and PK data for KW-2478 and Bortezomib in Phase 1 were presented by cohort, dose level and day.|PK collected Day 11 of 21-day cycle|The PK of KW-2478 was characterized after single administrations through @25 hours post start of infusion dose on Day 1 and through @7 hours post start of infusion dose on Day 11 in Phase 1 only.||hr*ng/mL||Standard Deviation|Mean
812225|NCT01063907|Secondary|Phase 1: PK Exposure Cmax ng/mL Day 11|Descriptive summary statistics (number, arithmetic mean, standard deviation [SDev], coefficient of variation [CV%]) for concentration and PK data for KW-2478 and Bortezomib in Phase 1 were presented by cohort, dose level and day.|PK collected Day 11 of 21-day cycle|The PK of KW-2478 was characterized after single administrations through @25 hours post start of infusion dose on Day 1 and through @7 hours post start of infusion dose on Day 11 in Phase 1 only.||ng/mL||Standard Deviation|Mean
812226|NCT01063907|Secondary|Phase 1: PK Absorption Tmax hr Day 11|Descriptive summary statistics (number, arithmetic mean, standard deviation [SDev], coefficient of variation [CV%]) for concentration and PK data for KW-2478 and Bortezomib in Phase 1 were presented by cohort, dose level and day.|PK collected Day 11 of 21-day cycle|The PK of KW-2478 was characterized after single administrations through @25 hours post start of infusion dose on Day 1 and through @7 hours post start of infusion dose on Day 11in Phase 1 only.||hr||Standard Deviation|Mean
812227|NCT01063907|Primary|To Establish the Safety, Tolerability, and RP2D (Phase 1); To Assess the Overall Response Rate in Subjects With Advanced Multiple Myeloma (Phase 2).|"The safety of KW-2478 was determined by reported TEAEs, observed DLTs, changes in PEs, vital sign measurements, ECGs, and laboratory analyses.
The ORR, was defined as the best response over a specified number of cycles (calculated and summarized).
Disease control rate (DCR) was defined as the best response over a specified number of cycles (calculated and summarized). Progression-free survival was defined as the time from the first day of treatment until the date of disease progression or death is first reported (calculated and summarized)."|21 day cycle, up to 52 weeks|All subjects who received at least 1 dose, including a partial dose, of KW-2478 were evaluated for safety.||participants|||Number
812228|NCT01064076|Primary|Percentage of Participants Who Pass Induced VF Conversion Test|Percentage of participants who pass induced VF conversion test was compared to a performance goal of 88%. Definition of a success was two consecutive successful 65 joule shocks out of four attempts in the same polarity.|Implant/Pre-Discharge|304 subjects had a complete VF conversion test recorded||percentage of participants||95% Confidence Interval|Number
812229|NCT01064076|Primary|Percentage of Participants Free of Type I Complications at 180 Days.|Percentage of Participants Free of Type I Complications at 180 days compared to the performance goal of 79%. Type I complications are those caused by the S-ICD System.|180 days|The analysis cohort includes all subjects undergoing an implant attempt.||percentage of participants||95% Confidence Interval|Number
812230|NCT01064167|Secondary|Postoperative Chest Tube Drainage||24h postoperative|||ml||Standard Deviation|Mean
812231|NCT01064167|Primary|Number of Patients Required Allogenic Red Blood Cells Transfusion||1month postoperative|As predefined by study protocol,Fourteen patients in the tranexamic acid group and Fifteen in the placebo group were withdrawn from the study due to conversion to on-pump surgery during the course of surgery.||participants|||Number
812232|NCT01064284|Secondary|To Evaluate the Incidence of All Other Adverse Events Related and Not Related to the Products Used||During the first 50 exposure days or first 3 years of enrollment, whichever occurs first|Data were not collected and the Outcome will never be analyzed|||||
812233|NCT01064284|Secondary|To Evaluate Laboratory Factors Potentially Associated to Inhibitor Development||During the first 50 exposure days or first 3 years of enrollment, whichever occurs first|Data were not collected and the Outcome will never be analyzed|||||
812234|NCT01064284|Secondary|To Evaluate Clinical Factors Potentially Associated to Inhibitor Development||During the first 50 exposure days or first 3 years of enrollment, whichever occurs first|Data were not collected and the Outcome will never be analyzed|||||
812235|NCT01064284|Secondary|To Evaluate the Modality of Occurrence of Inhibitors (Titre at Onset)|Inhibitor Titre at Onset|During 6 months of observation, from the inhibitor occurrence|||Bethesda Units||Full Range|Median
812236|NCT01064284|Secondary|To Evaluate the Modality of Occurrence of Inhibitors (Number of EDs)|Number of EDs: Number of Exposure Days (EDs) after which the inhibitors develop|During the first 50 exposure days or first 3 years of enrollment, whichever occurs first|||Exposure days||Full Range|Median
812237|NCT01064284|Secondary|To Evaluate the Frequency of Transient Inhibitors|Number of participants for each group who developed transient inhibitors (this means, those inhibitors which disappeared spontaneously within 6 months without immunotolerance treatment).|In the 6 months after inhibitor development|Data at 6‑month follow‑up were missing for two patients assigned to plasma‑ derived factor VIII and three patients assigned to recombinant factor VIII.||participants|||Number
812238|NCT01064284|Secondary|To Evaluate the Anamnestic Response of Inhibitor Patients||During the first 50 exposure days or first 3 years of enrollment, whichever occurs first|Data were not collected and the Outcome will never be analyzed.|||||
812239|NCT01064284|Primary|To Assess the Immunogenicity of Plasma Derived VWF/FVIII and rFVIII Concentrates by Determining the Frequency of Inhibitor Development in the First 50 EDs or in the First 3 Years From Enrolment, Whichever Comes First in PUPs and MBCTs|"Expressed with the numebr of patients for each group who developed FVIII inhibitors.
PUPs: Previously Untreated Patients MBCTPs: Minimally Blood Component-Treated Patients"|During the first 50 exposure days or first 3 years of enrollment, whichever occurs first|||participants||95% Confidence Interval|Number
812240|NCT01064297|Primary|Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy Without Valproate According to Dose of Lamotrigine Received|The number of infants with the reported MCM following first trimester exposure to lamotrigine polytherapy without valproate were counted.|Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported after assessments made in the delivery room or shortly after birth|Among lamotrigine polytherapy without valproate exposures in the first trimester: live births, fetal deaths, induced abortions with defects, and live births without defects. Due to the likely inconsistent identification of defects among spontaneous losses, fetal deaths, and induced abortions without reported defects, those offspring were excluded.||infants|||Number
812241|NCT01064297|Primary|Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy With Valproate According to Dose of Lamotrigine Received|The number of infants with the reported MCM following first trimester exposure to lamotrigine polytherapy with valproate were counted.|Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported after assessments made in the delivery room or shortly after birth|Among lamotrigine polytherapy with valproate exposures in the first trimester: live births, fetal deaths, induced abortions with defects, and live births without defects. Due to the likely inconsistent identification of defects among spontaneous losses, fetal deaths, and induced abortions without reported defects, those offspring were excluded.||infants|||Number
812478|NCT01070810|Secondary|Number of Participants With Shock Reversal|Shock reversal was defined as > 24 hours off all vasopressors|Hospital stay, average 2 weeks|||Participants|||Count of Participants
812479|NCT01070810|Primary|Lactate Level 24 Hours After the First Study Medication Dose||24 hours|||mmol/L||Inter-Quartile Range|Median
812242|NCT01064297|Primary|Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received|The number of infants with the reported MCM following first trimester lamotrigine monotherapy exposure were counted. Registry personnel contacted the enrolling physician to obtain information on the pregnancy outcome, lamotrigine dosing and duration of exposure, and use of concomitant antiepileptic drugs during pregnancy.|Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported after assessments made in the delivery room or shortly after birth|Among lamotrigine monotherapy exposures in the first trimester: live births, fetal deaths, induced abortions with defects, and live births without defects. Due to the likely inconsistent identification of defects among spontaneous losses, fetal deaths, and induced abortions without reported defects, these offspring were not included in analyses.||infants|||Number
812243|NCT01064297|Primary|Number of Infants With Major Congenital Malformations (MCMs) by Earliest Trimester of Exposure to Lamotrigine Polytherapy Without Valproate|The number of infants with major congenital malformations were counted and are presented by earliest trimester of exposure to lamotrigine polytherapy without valproate.|Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported following assessments made in the delivery room or shortly after birth|Among lamotrigine polytherapy without valproate exposures: live births, fetal deaths, induced abortions with defects, and live births without defects. Due to the likelihood of inconsistent identification of defects among spontaneous losses, fetal deaths, and induced abortions without reported defects, these offspring were not included in analyses.||infants|||Number
812244|NCT01064297|Primary|Number of Infants With Major Congenital Malformations (MCMs) by Earliest Trimester of Exposure to Lamotrigine Polytherapy With Valproate|The number of infants with major congenital malformations were counted and are presented by earliest trimester of exposure to lamotrigine polytherapy with valproate.|Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported following assessments made in the delivery room or shortly after birth|Among lamotrigine polytherapy with valproate exposures: live births, fetal deaths, induced abortions with defects, and live births without defects. Due to the likelihood of inconsistent identification of defects among spontaneous losses, fetal deaths, and induced abortions without reported defects, these offspring were not included in analyses.||infants|||Number
812245|NCT01064297|Primary|Number of Infants With Major Congenital Malformations by Earliest Trimester of Exposure to Lamotrigine Monotherapy|Among lamotrigine monotherapy exposures: live births, fetal deaths, induced abortions with birth defects, and live births without defects. Due to the likelihood of inconsistent identification of birth defects among spontaneous losses, fetal deaths, and induced abortions without reported birth defects, these offspring were not included in analyses.|Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported after assessments made in the delivery room or shortly after birth|Among lamotrigine monotherapy exposures: live births, fetal deaths, induced abortions with birth defects, and live births without defects. Due to the likelihood of inconsistent identification of birth defects among spontaneous losses, fetal deaths, and induced abortions without reported birth defects, these offspring were not included in analyses.||infants|||Number
812246|NCT01064297|Primary|Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Polytherapy Without Valproate|The number of live births, fetal deaths with pregnancy loss occurring >=20 weeks gestation, induced abortions, and spontaneous pregnancy losses were recorded according to the time at which women were first exposed to lamotrigine polytherapy without valproate. Due to inconsistent identification of major congenital malformations (MCMs) among spontaneous losses, no comment is made concerning the presence or absence of MCMs. Although birth defects may not have been reported, they cannot be ruled out.|Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported following assessments made in the delivery room or shortly after birth|Prospectively enrolled pregnancies exposed to the lamotrigine polytherapy without valproate||infants|||Number
812247|NCT01064297|Primary|Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Polytherapy With Valproate|The number of live births, fetal deaths, induced abortions, and spontaneous pregnancy losses were recorded according to the time at which women were first exposed to lamotrigine polytherapy with valproate. Due to inconsistent identification of major congenital malformations (MCMs) among spontaneous losses, no comment is made concerning the presence or absence of MCMs.|Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported following assessments made in the delivery room or shortly after birth|Prospectively enrolled pregnancies exposed to lamotrigine polytherapy with valproate.||infants|||Number
812248|NCT01064297|Primary|Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Monotherapy|The number of live births, fetal deaths, induced abortions, and spontaneous pregnancy losses were recorded according to the time at which women were first exposed to lamotrigine monotherapy. Due to inconsistent identification of major congenital malformations (MCMs) among spontaneous losses, no comment is made concerning the presence or absence of MCMs.|Although reports and diagnoses of major congenital malformations are accepted up to six years after the birth, the majority of malformations are reported after assessments made in the delivery room or shortly after birth|Prospectively enrolled pregnancies exposed to lamotrigine monotherapy.||infants|||Number
812249|NCT01064310|Secondary|Change From Baseline (BL) in Heart Rate|Heart rate (HR) is the number of heartbeats per unit of time, typically expressed as beats per minute. HR can vary as the body's need to absorb oxygen and excrete carbon dioxide changes, such as during exercise or sleep. A normal resting HR ranges from 60 to 100 beats per minute. Mean change from BL for each assessment week was calculated as the average change from period BL at the specified visits (combining data across P 1 and 2 for Weeks 2 and 6). Study weeks are approximate; participants could have crossed over from P 1 to P 2 at earlier time points than specified in the protocol.|Baseline of Period (P) 1 (Screening); Period 1 Weeks 2 and 6 (Study Weeks 2 and 6); Baseline of Period 2 (Washout=Study Week 12); Period 2 Weeks 2, 6, and 10 (Study Weeks 14, 18, and 22)|Safety-Randomized Study Population. All participants who received sunitinib or pazopanib either during Period 1 or Period 2 were counted in both treatment groups (sunitinib and pazopanib). Only those participants contributing data at the indicated time points were evaluated.||Beats per minute||Standard Deviation|Mean
812250|NCT01064310|Secondary|Change From Baseline (BL) in Systolic Blood Pressure (SBP) and Diastolic BP (DBP)|When the heart beats, it contracts and pushes blood through the arteries to the rest of body. This force creates pressure on the arteries called SBP. DBP is the pressure in the arteries when the heart rests between beats. Normal levels: SBP (120 mmHg or less); DBP (80 mmHg or less). Mean change from BL for each assessment week was calculated as the average change from period BL at the specified visits (combining data across P 1 and 2 for Weeks 2 and 6). Study weeks are approximate; participants could have crossed over from P 1 to P 2 at earlier time points than specified in the protocol.|Baseline of Period (P) 1 (Screening); Period 1 Weeks 2 and 6 (Study Weeks 2 and 6); Baseline of Period 2 (Washout=Study Week 12); Period 2 Weeks 2, 6, and 10 (Study Weeks 14, 18, and 22)|Safety-Randomized Study Population. All participants who received sunitinib or pazopanib either during Period 1 or Period 2 were counted in both treatment groups (sunitinib and pazopanib). Only those participants contributing data at the indicated time points were evaluated.||Millimeters of mercury (mmHg)||Standard Deviation|Mean
812251|NCT01064310|Secondary|Number of Participants With the Indicated AEs Leading to Permanent Discontinuation of Study Treatment|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE that spans more than one period is considered to be an AE for each period during which the AE increased in grade. There is only one action with respect to study drug recorded for the whole event. As such, it is not always possible to determine in which study period treatment was discontinued due to the AE.|Baseline to end of study (maximum of 22 weeks)|Safety-Randomized Study Population. Only those participants with adverse events leading to permanent discontinuation of study treatment were evaluated.||participants|||Number
812252|NCT01064310|Secondary|Number of Participants With Grade 1 to Grade 5 Adverse Events (AEs)|AEs were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No AE or within normal limits; 1 = Mild AE; 2 = Moderate AE; 3 = Severe and undesirable AE; 4 = Life-threatening or disabling AE; 5 = Death related to AE.|Baseline to end of study (maximum of 22 weeks)|Safety-Randomized Study Population||participants|||Number
812253|NCT01064310|Secondary|Number of Participants With the Indicated Reason for Receiving a Dose Reduction|Dose reduction of study drug was a stepwise reduction of the dose of the study drug: one less capsule was received at each step reduction. Participants were monitored for approximately 10 to 14 days at each dose level. Participants are recorded under the treatment they were receiving at the time the dose reduction was reported.|End of second treatment period (maximum of 22 weeks)|"Safety-Randomized Study Population. Only those participants who had an dose reduction were evaluated. Participants may be counted multiple times for the same reason for a dose reduction if the participant had multiple reductions for the same reason."||participants|||Number
812254|NCT01064310|Secondary|Number of Participants With the Indicated Number of Dose Reductions|Participants are recorded under the treatment they were receiving at the time the dose reduction was reported.|End of second treatment period (maximum of 22 weeks)|Safety-Randomized Study Population. Only those participants who had an dose reduction were evaluated.||participants|||Number
812255|NCT01064310|Secondary|Time to Dose Modification|For the subset of participants who had a dose modification, time to dose modification was defined as the time from the first dose in each period until the first reduction in dose within a period.|End of second treatment period (maximum of 22 weeks)|Safety-Randomized Study Population. Only those participants who had a dose modification were evaluated.||weeks||95% Confidence Interval|Median
812256|NCT01064310|Secondary|Quality of Life as Assessed by the EuroQoL-5 Dimensions (EQ-5D) Thermometer and Utility Scores|The EQ-5D is a participant-answered questionnaire measuring 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D has two separate components: utility score and thermometer score. The EQ-5D total utility score ranges from 0 (worst health state) to 1 (perfect health state); 1 reflects the best outcome. The thermometer score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).|Day 1 (Period 1 Pre-dose); during 2-week Wash-out Period (Study Weeks 11 and 12); and End of Study (Week 10 of Period 2 [Study Week 22])|Safety-Randomized Study Population. Participants (par.) who received mixed treatment within a period were excluded. Only those par. contributing data at the indicated time points were evaluated. In some instances, par. may have contributed data for one score, but not the other; thus, the number of par. analyzed reflects the entire population.||Scores on a scale||Standard Deviation|Mean
812257|NCT01064310|Secondary|Change From Period Baseline (BL) in Fatigue as Assessed by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score|Change from period (P) BL is computed as participants' (par.) average post-BL fatigue score within each P minus their P-specific BL score. P 1 BL is the P 1 Pre-Dose assessment; P 2 BL is the wash-out assessment. Crossover analyses compared par. average scores on each treatment, adjusting for sequence. FACIT-Fatigue Scale: overall score (0 to 52)=the sum of scores for 13 questions. For each question, par. rated their condition for the past week on a 5-point scale: 0 (not at all) to 4 (very much). A high score indicates low fatigue. A negative change from BL represents a worsening of condition.|Day 1 (Period [P] 1 Pre-dose); Weeks 2, 4, 6, 8, and 10 of P 1; during 2-week Wash-out Period (Study Weeks 11 and 12); Weeks 2, 4, 6, and 8 of P 2 (Study Weeks 14, 16, 18, 20, and 22, respectively); End of Study (Week 10 of P 2 [Study Week 22])|Safety-Randomized Study Population: participants who received at least one dose of either drug regardless of treatment period. Participants who received mixed treatment within a period were excluded. Only those participants contributing data at the indicated time points were evaluated.||Scores on a scale||Standard Deviation|Mean
812258|NCT01064310|Primary|"Number of Participants Answering Yes, no, or Not Applicable (N/A) to the Question of Whether the Indicated Factors Influenced Their Preference for Sunitinib or Pazopanib Treatment as Assessed by the Patient Preference Questionnaire"|The PPQ is used to measure participants’ preference for pazopanib or sunitinib for renal cell carcinoma management and is used to determine a participant's preference for 1 of the 2 drugs given in the 2 double-blind treatment periods. Participants were asked to select 1 of the following: 1. prefer the drug taken as the first treatment; 2. prefer the drug taken as the second treatment; or 3, no preference. Those participants who indicated a preference were asked to select the factors that had an influence on their treatment preference, as well as the most important reason for their preference.|End of treatment of both study drugs (maximum of 22 weeks)|mITT Population. Responses to some categories of the PPQ may be missing for some participants.||participants|||Number
812259|NCT01064310|Primary|Number of Participants With Preference for Pazopanib Versus Sunitinib as Assessed by the Patient Preference Questionnaire (PPQ)|The PPQ is used to measure participants’ preference for pazopanib or sunitinib for renal cell carcinoma management and is used to determine a participant's preference for 1 of the 2 drugs given in the 2 double-blind treatment periods. Participants were asked to select 1 of the following: 1. prefer the drug taken as the first treatment; 2. prefer the drug taken as the second treatment; or 3, no preference. Those participants who indicated a preference were asked to select the factors that had an influence on their treatment preference, as well as the most important reason for their preference.|End of treatment of both study drugs (maximum of 22 weeks)|Modified-Intent-to-Treat (mITT) Population (used for the primary analysis): participants who received at least one dose of study treatment from each treatment period and who did not have documented progressive disease (PD) at the end of Treatment Period 1 and completed the patient preference questionnaire.||participants|||Number
812260|NCT01064323|Primary|Red Blood Cell Nitric Oxide|nM|1 hour after IPC|||nM||Standard Deviation|Mean
812261|NCT01064323|Primary|Plasma S-nitrosothiols|nM|baseline|||nM||Standard Deviation|Mean
812262|NCT01064323|Primary|Red Blood Cell Nitric Oxide|nM|1 hour after IPC|Data was not collected for 1 participant for this outcome measure.||nM||Standard Deviation|Mean
812263|NCT01064323|Primary|Red Blood Cell Nitric Oxide|nM|baseline|Data was not collected for 1 participant for this outcome measure.||nM||Standard Deviation|Mean
812264|NCT01064323|Primary|Plasma Nitrite|nM|1 hour after IPC|||nM||Standard Deviation|Mean
812265|NCT01064323|Primary|Plasma Nitrite|nM|baseline|||nM||Standard Deviation|Mean
812266|NCT01064323|Primary|Brachial Occlusion-mediated Constriction|Brachial Occlusion-mediated constriction measured via ultrasound, %|1 hour after IPC|Data for this outcome measure was only available for 8 out of 10 participants due to reduced image quality.||percentage of constriction||Standard Deviation|Mean
812267|NCT01064323|Primary|Brachial Occlusion-mediated Constriction|Brachial Occlusion-mediated constriction measured via ultrasound, %|baseline|Data for this outcome measure was only available for 8 out of 10 participants due to reduced image quality.||percentage of constriction||Standard Deviation|Mean
812268|NCT01064323|Primary|Brachial Occlusion-mediated Constriction|Brachial Occlusion-mediated constriction measured via ultrasound, mm|1 hour after IPC|||mm||Standard Deviation|Mean
812269|NCT01064323|Primary|Brachial Occlusion-mediated Constriction|Brachial Occlusion-mediated constriction measured via ultrasound, mm|baseline|||mm||Standard Deviation|Mean
812270|NCT01064323|Primary|Brachial Flow Dilation|Brachial Flow Mediated dilation, %|1 hour after IPC|||percentage of dilation||Standard Deviation|Mean
812271|NCT01064323|Primary|Brachial Flow Dilation|Brachial Flow Mediated dilation, %|baseline|||percentage of dilation||Standard Deviation|Mean
812272|NCT01064323|Primary|Brachial Flow Dilation|Brachial Flow Mediated dilation, mm|1 hour after IPC|||mm||Standard Deviation|Mean
812273|NCT01064323|Primary|Brachial Flow Dilation|Brachial Flow Mediated dilation, mm|baseline|||mm||Standard Deviation|Mean
812274|NCT01064323|Primary|Brachial Diameter|mm|1 hour after leg IPC|||mm||Standard Deviation|Mean
812275|NCT01064323|Primary|Brachial Diameter|mm|baseline|||mm||Standard Deviation|Mean
812276|NCT01064323|Primary|Brachial Flow Velocity|Measured using ultrasound, units cm/sec.|50 minutes into IPC|||cm/sec||Standard Deviation|Mean
812277|NCT01064323|Primary|Brachial Flow Velocity|Measured using ultrasound, units cm/sec.|5 minutes into leg intermittent pneumatic compression|||cm/sec||Standard Deviation|Mean
812278|NCT01064323|Primary|Brachial Flow Velocity|Brachial flow velocity measured using ultrasound. Units cm/sec.|Baseline|||cm/sec||Standard Deviation|Mean
812279|NCT01064362|Secondary|Number of Participants With the Indicated Haemorrhages During Hospitalization for Major Orthopaedic Surgery of Lower Limbs (MOSLL)|Haemorrhages during MOSLL hospitalization or follow-up as identified by ICD-9-CM codes were measured. The PHARMO medical record linkage system (RLS), in the Netherlands, is a population-based patient-centric data tracking system that includes high quality/ complete information of patient demographics, drug dispensing, and hospital morbidity records of approximately 2.3 million inhabitants in the Netherlands.|Follow-up continued until the date of first event, death, end of initial therapy, hospital discharge, end of follow-up in PHARMO RLS, or 60 days after discharge, whichever came first.|From the PHARMO RLS, all patients >=18 years of age with in-hospital pharmacy data, a primary discharge diagnosis for hip fracture and/or a hospitalization for MOSLL, and follow-up between January 2003 (introduction of Arixtra) and December 2008.||participants|||Number
812280|NCT01064362|Primary|Number of Participants With the Indicated Types of Haemorrhages During Hospitalization or Follow-up for Major Orthopaedic Surgery of Lower Limbs (MOSLL)|Haemorrhages during MOSLL hospitalization or follow-up as identified by ICD-9-CM codes were measured. The PHARMO medical record linkage system (RLS), in the Netherlands, is a population-based patient-centric data tracking system that includes high quality/ complete information of patient demographics, drug dispensing, and hospital morbidity records of approximately 2.3 million inhabitants in the Netherlands.|Follow-up continued until the date of first event, death, end of initial therapy, hospital discharge, end of follow-up in PHARMO RLS, or 60 days after discharge, whichever came first|From the PHARMO RLS, all patients >=18 years of age with in-hospital pharmacy data, a primary discharge diagnosis for hip fracture and/or a hospitalization for MOSLL, and follow-up between January 2003 (introduction of Arixtra) and December 2008.||participants|||Number
812281|NCT01064401|Secondary|Percentage of Participants With a ≥ 7.5 Point Worsening From Baseline in the Multiple Sclerosis Impact Scale (MSIS-29) Physical Impact Score at 96 Weeks|The MSIS-29 is a 29-item disease-specific patient-reported outcome measure that has been developed and validated to examine the physical and psychological impact of MS from a patient’s perspective; it measures physical and psychological items. Worsening in the MSIS-29 physical score is defined as an increase of ≥ 7.5 points in the MSIS-29 physical score at 96 weeks compared to baseline. If a participant was missing data for less than 10 of the 20 items that make up the physical score, then the mean of the non-missing items were used for the missing items. If a participant was missing 10 or more of the 20 items that make up the physical score, or missing the questionnaire entirely, or if the questionnaire was completed after the participant switched to alternative MS medication, a random effects model was used to estimate the MSIS-29 physical score.|Baseline and 96 weeks|participants with a baseline and Week 96 assessment||percentage of participants|||Number
812282|NCT01064401|Secondary|Proportion of Participants Relapse-free at Week 144|Relapses are defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the examining neurologist. Only relapses confirmed by INEC are included in this analysis. Data after participants switched to alternative MS medications are excluded. The estimated proportion of subjects relapse-free at Week 144 is based on the Kaplan-Meier product limit method.|144 weeks|||proportion of participants|||Number
812283|NCT01064401|Secondary|Proportion of Participants With Sustained Disability Progression at 144 Weeks|Sustained disability progression is defined as: at least a 1.0-point increase on the EDSS from Baseline EDSS ≥ 1.0 that is sustained for 12 weeks, or at least a 1.5-point increase on the EDSS from baseline EDSS = 0 that is sustained for 12 weeks. The EDSS measures the disability status of people with MS on a scale that ranges from 0 to 10, with higher scores indicating more disability. Estimated proportion of participants with progression is based on the Kaplan-Meier product limit method. Participants were censored at the time of withdrawal/switch if they withdrew from study or switched to alternative MS medication without a progression. Participants with a tentative progression at the End of Treatment Period Visit (or the last EDSS assessment prior to alternative MS start date) and no confirmation assessment were censored at their last EDSS assessment.|Baseline through 144 weeks|||proportion of participants|||Number
812284|NCT01064401|Secondary|Adjusted Mean Number of New or Newly Enlarging T2 Hyperintense Lesions up to Week 96|The quantity of lesions is assessed by brain magnetic resonance imaging (MRI). The adjusted mean number is estimated from a negative binomial regression model, adjusted for baseline volume of T2 from a negative binomial regression model, adjusted for baseline volume of T2 hyperintense lesions, history of prior IFN beta use and baseline age (≤ 35 vs > 35 years). To account for the timing of the MRI measurement, the logarithmic transformation of the scan number of the MRI assessment is included in the model as the 'offset' parameter. Observed data after participants switched to alternative MS medications are excluded. Missing data are not imputed. Only observed new or newly enlarging T2 lesions at the last visit of the participant up to Week 96 visit are used in this analysis.|up to 96 weeks|participants with baseline and at least one post-baseline MRI measurement||lesions||95% Confidence Interval|Mean
812285|NCT01064401|Primary|Adjusted Annualized Relapse Rate (ARR)|Relapses are defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the examining neurologist. Only relapses confirmed by Independent Neurology Evaluation Committee (INEC) are included in this analysis. Adjusted ARR was estimated from a negative binomial regression model adjusted for the baseline relapse rate, history of prior IFN beta use, baseline Expanded Disability Status Scale score (EDSS; ≤ 2.5 vs > 2.5) and baseline age (≤ 35 vs > 35 years). Data after participants switched to alternative MS medications are excluded.|Up to 144 weeks|participants with a relapse||relapses per person-years|Participants|95% Confidence Interval|Number
812286|NCT01064414|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26|The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||mg/dL||Standard Error|Least Squares Mean
812287|NCT01064414|Secondary|Percentage of Patients With HbA1c <7% at Week 26|The table below shows the percentage of patients with HbA1c <7% at Week 26 in each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage.|Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percentage of patients|||Number
812288|NCT01064414|Primary|Change in HbA1c From Baseline to Week 26|The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percent||Standard Error|Least Squares Mean
812289|NCT01064622|Secondary|Activity (Overall Response Rate) in Crossover Patients|RECIST response rate in patients after crossover from placebo to vismodegib arm. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 6 months|Phase I lead-in patients were not included in the efficacy analyses.||percentage of participants||95% Confidence Interval|Number
812290|NCT01064622|Secondary|Incidence of Adverse Events|Details are provided in Adverse Events section below. Reported here are percentage of patients in each arm with any grade 1 or higher adverse event, regardless of attribution.|Up to 3 years|||percentage of participants||95% Confidence Interval|Number
812291|NCT01064622|Secondary|Objective Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 6 months|Phase I lead-in patients were not included in the efficacy analysis.||percentage of participants||95% Confidence Interval|Number
812292|NCT01064622|Secondary|Overall Survival|Time from randomization to death from any cause. Estimated in the two treatment groups by the Kaplan-Meier method and compared using a stratified logrank test.|Up to 3 years|Phase I lead-in patients were not included in the efficacy analysis.||months||95% Confidence Interval|Median
814515|NCT01088711|Primary|Number of Participants Experiencing an Adverse Event (AE)||Up to Day 36|AEs were monitored in all obese healthy (Panel A) and Type 2 diabetes (T2D) (Panel B) participants who received omarigliptin 50 mg or placebo.||Participants|||Number
812294|NCT01064687|Secondary|Pharmacokinetics: Area Under the Concentration Curve (AUC) for LY2189265|Evaluable pharmacokinetic concentrations from the 4-week, 13-week, 26-week, and 52-week timepoints were combined and utilized in a population approach to determine the population mean estimate and standard deviation at steady-state.|4 weeks, 13 weeks, 26 weeks, and 52 weeks|Participants who were randomized at baseline to LY2189265 and received at least 1 dose of study drug with evaluable AUC data.||nanogram hours per milliliter (ng*hr/mL)||Standard Deviation|Mean
812295|NCT01064687|Secondary|Change From Baseline to 26 Weeks in N Terminal Pro Brain Natriuretic Peptide (NT-proBNP)||Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable NT-proBNP data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||picograms per milliliter (pg/mL)||Inter-Quartile Range|Median
812296|NCT01064687|Secondary|Change From Baseline to 52 Weeks in Hematological and Biochemical Lab Values||Baseline, 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug.||||Standard Error|Least Squares Mean
812297|NCT01064687|Secondary|Change From Baseline to 26 Weeks in Hematological and Biochemical Lab Values||Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo.||||Standard Error|Least Squares Mean
812298|NCT01064687|Secondary|Number of Participants With Treatment Emergent Adverse Events at 52 Weeks|A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with one or more TEAE is summarized cumulatively at 52 weeks, with the exception of the Placebo/1.5 mg LY2189265 and Placebo/0.75 mg LY2189265 treatment groups, which include only TEAEs that occurred during treatment with LY2189265 (26 weeks through 52 weeks). A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 52 weeks|Participants who were randomized at baseline to LY2189265, Exenatide, or Placebo and received at least 1 dose of study drug.||participants|||Number
812299|NCT01064687|Secondary|Number of Participants With Treatment Emergent Adverse Events at 26 Weeks|A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with one or more TEAE is summarized cumulatively at 26 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo.||participants|||Number
812300|NCT01064687|Secondary|Number of Participants With LY2189265 Antibodies at 52 Weeks and 4 Weeks After Last Dose of Study Drug|LY2189265 (Dulaglutide) anti-drug antibodies (ADA) were assessed. The number of participants with initial postbaseline detection of treatment emergent (defined as a 4-fold increase in the ADA titer from baseline) LY2189265 ADA were summarized.|26 weeks through 52 weeks and 53 weeks through 4 weeks after last dose|Participants who were randomized and received at least one dose of LY2189265, Exenatide, or Placebo with evaluable LY2189265 ADA data. In the clinically evaluated dose range of LY2189265, no dose effect on the magnitude of the anti-LY2189265 immune response was observed. Therefore, results were combined for the 0.75 mg and 1.5 mg LY2189265 groups.||participants|||Number
812301|NCT01064687|Secondary|Number of Participants With LY2189265 Antibodies at 26 Weeks|LY2189265 (Dulaglutide) anti-drug antibodies (ADA) were assessed. The number of participants with initial postbaseline detection of treatment emergent (defined as a 4-fold increase in the ADA titer from baseline) LY2189265 ADA were summarized.|Baseline through 26 weeks|Participants who were randomized and received at least one dose of LY2189265, Exenatide, or Placebo with evaluable LY2189265 ADA data. In the clinically evaluated dose range of LY2189265, no dose effect on the magnitude of the anti-LY2189265 immune response was observed. Therefore, results were combined for the 0.75 mg and 1.5 mg LY2189265 groups.||participants|||Number
812302|NCT01064687|Secondary|Number of Participants Requiring Rescue Therapy Due to Hyperglycemia at 52 Weeks|"Rescue therapy was defined as any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation. Participants who had no rescue therapy within specified study period were considered as censored observations at the last available contact date up to specified study period. Time to start first new glucose-lowering intervention due to hyperglycemia (rescue therapy) was analyzed between the groups using the semi-parametric proportional hazard regression model with treatment group and country as fixed effects and baseline glycosylated hemoglobin (HbA1c) as a covariate."|Baseline through 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug.||participants|||Number
812303|NCT01064687|Secondary|Number of Participants Requiring Rescue Therapy Due to Hyperglycemia at 26 Weeks|"Rescue therapy was defined as any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation. Participants who had no rescue therapy within specified study period were considered as censored observations at the last available contact date up to specified study period. Time to start first new glucose-lowering intervention due to hyperglycemia (rescue therapy) was analyzed between the groups using the semi-parametric proportional hazard regression model with treatment group and country as fixed effects and baseline glycosylated hemoglobin (HbA1c) as a covariate."|Baseline through 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo.||participants|||Number
812312|NCT01064687|Secondary|Number of Participants With Adjudicated Pancreatitis at 52 Weeks|The number of participants with pancreatitis confirmed by adjudication is summarized cumulatively at 52 weeks, with the exception of the Placebo/1.5 mg LY2189265 and Placebo/0.75 mg LY2189265 treatment groups, which include only participants with confirmed pancreatitis during treatment with LY2189265 (26 weeks through 52 weeks). A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 52 weeks|Participants who were randomized at baseline to LY2189265, Exenatide, or Placebo and received at least 1 dose of study drug.||participants|||Number
824784|NCT01178268|Secondary|Follow-up In-stent Percent Diameter Stenosis (DS)||≥13 months|The number of participants with angiographic follow up available was analysed.||percent Diameter stenosis|Participants|Standard Deviation|Mean
812304|NCT01064687|Secondary|Rate of Self-reported Hypoglycemic Events at 52 Weeks|Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of equal to or less than millimoles/liter [mmol/L]), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of equal to or less than 3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The 1-year adjusted rate of hypoglycemic events is summarized cumulatively at 52 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug. Only pre-rescue measurements were used.||events per participant per year||Standard Deviation|Mean
812305|NCT01064687|Secondary|Rate of Self-reported Hypoglycemic Events at 26 Weeks|Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of equal to or less than 3.9 millimoles/liter [mmol/L]), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of equal to or less than 3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The 1-year adjusted rate of hypoglycemic events is summarized cumulatively at 26 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 weeks|Participants who were randomized and received at least one dose of LY2189265, Exenatide, or Placebo. Only pre-rescue measurements were used.||events per participant per year||Standard Deviation|Mean
812306|NCT01064687|Secondary|Number of Self-reported Hypoglycemic Events at 52 Weeks|Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of less than or equal to 3.9 millimoles/liter [mmol/L]), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of less than or equal to 3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The number of self-reported hypoglycemic events is summarized cumulatively at 52 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug.||events|||Number
812307|NCT01064687|Secondary|Number of Self-reported Hypoglycemic Events at 26 Weeks|Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of less than or equal to 3.9 millimoles/liter [mmol/L]), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of less than or equal to 3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The number of self-reported hypoglycemic events is summarized cumulatively at 26 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo.||events|||Number
812308|NCT01064687|Secondary|Change From Baseline to 52 Weeks on Serum Calcitonin||Baseline, 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable serum calcitonin data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||picograms per milliliter (pg/mL)||Standard Deviation|Mean
812309|NCT01064687|Secondary|Change From Baseline to 26 Weeks on Serum Calcitonin||Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable serum calcitonin data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||picograms per milliliter (pg/mL)||Standard Deviation|Mean
812310|NCT01064687|Secondary|Change From Baseline to 52 Weeks on Pancreatic Enzymes|Amylase (total and pancreas-derived) and lipase concentrations were measured.|Baseline, 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable pancreatic enzyme data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||units per liter||Inter-Quartile Range|Median
812311|NCT01064687|Secondary|Change From Baseline to 26 Weeks on Pancreatic Enzymes|Amylase (total and pancreas-derived) and lipase concentrations were measured.|Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable pancreatic enzyme data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||units per liter||Inter-Quartile Range|Median
812313|NCT01064687|Secondary|Number of Participants With Adjudicated Pancreatitis at 26 Weeks|The number of participants with pancreatitis confirmed by adjudication is summarized cumulatively at 26 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo.||participants|||Number
812314|NCT01064687|Secondary|Change From Baseline to 52 Weeks on Blood Pressure|Seated systolic blood pressure (SBP) and seated diastolic blood pressure (DBP) were measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable blood pressure data.||millimeters of mercury (mmHg)||Standard Error|Mean
812315|NCT01064687|Secondary|Change From Baseline to 26 Weeks on Blood Pressure|Seated systolic blood pressure (SBP) and seated diastolic blood pressure (DBP) were measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26 weeks|Participants who were randomized and received at least one dose of LY2189265, Exenatide, or Placebo with evaluable blood pressure data.||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
812316|NCT01064687|Secondary|Change in Baseline to 52 Weeks on Pulse Rate|Seated pulse rate was measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable seated pulse rate data.||beats per minute (bpm)||Standard Error|Least Squares Mean
812317|NCT01064687|Secondary|Change in Baseline to 26 Weeks on Pulse Rate|Seated pulse rate was measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable seated pulse rate data.||beats per minute (bpm)||Standard Error|Least Squares Mean
812318|NCT01064687|Secondary|Change From Baseline to 52 Weeks on Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. PR is the interval between the P wave and the QRS complex. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable ECG QTcF Interval or PR Interval data.||milliseconds (msec)||Standard Error|Least Squares Mean
812319|NCT01064687|Secondary|Change From Baseline to 26 Weeks on Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. PR is the interval between the P wave and the QRS complex. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable ECG QTcF Interval or PR interval data.||milliseconds (msec)||Standard Error|Least Squares Mean
812320|NCT01064687|Secondary|Number of Participants With Adjudicated Cardiovascular Events at 52 Weeks|Information on cardiovascular (CV) risk factors was collected at baseline. Data on any new CV event was prospectively collected using a CV event electronic case report form. At prespecified visits, participants were asked about any new CV event since the previous inquiry. Deaths and nonfatal cardiovascular adverse events (AEs) were adjudicated by an external committee of physicians with cardiology expertise. Nonfatal cardiovascular AEs to be adjudicated included myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions, and cerebrovascular events, including cerebrovascular accident (stroke) and transient ischemic attack. The number of participants with CV events confirmed by adjudication is summarized cumulatively at 52 weeks. Serious and all other non-serious adverse events regardless of causality are summarized in the Reported Adverse Events module.|Baseline through 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug. The number of participants with adjudicated CV events was not collected at 26 weeks.||participants|||Number
812321|NCT01064687|Secondary|Change From Baseline to 52 Weeks on the Impact of Weight on Self-Perception|The Impact of Weight on Self-Perception (IW-SP) questionnaire contains 3 items that assess how often the participants' body weight affects how happy they are with their appearance and how often they feel self-conscious when out in public. Items are scored on a 5-point numeric rating scale where 5 = never and 1 = always. A single total score is calculated by summing the scores for all 3 items. Total score ranges between 3 and 15, where a higher score is indicative of better self-perception. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate.|Baseline, 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable IW-SP data. Only pre-rescue measurements were used. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||units on a scale||Standard Error|Least Squares Mean
812334|NCT01064687|Secondary|Change From Baseline to 26 Weeks for Daily Mean Blood Glucose Values From the 8-point Self-monitored Plasma Glucose (SMPG) Profiles|The SMPG data were collected at the following 8 time points: pre-morning meal; 2 hours post-morning meal; pre-midday meal; 2 hours post-midday meal; pre-evening; 2 hours post-evening meal; bedtime; and 3AM or 5 hours after bedtime. Least squares (LS) means of the mean of the 8 time points (daily mean) were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, country, visit, and treatment-by-visit as fixed effects and baseline as a covariate.|Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable SMPG data. Only pre-rescue measurements were used.||milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
812322|NCT01064687|Secondary|Change From Baseline to 26 Weeks on the Impact of Weight on Self-Perception|The Impact of Weight on Self-Perception (IW-SP) questionnaire contains 3 items that assess how often the participants' body weight affects how happy they are with their appearance and how often they feel self-conscious when out in public. Items are scored on a 5-point numeric rating scale where 5 = never and 1 = always. A single total score is calculated by summing the scores for all 3 items. Total score ranges between 3 and 15, where a higher score is indicative of better self-perception. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate.|Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable IW-SP data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||units on a scale||Standard Error|Least Squares Mean
812323|NCT01064687|Secondary|Change From Baseline to 52 Weeks in the Impact of Weight on Activities of Daily Living|"The Impact of Weight on Activities of Daily Living (renamed the Ability to Perform Physical Activities of Daily Living [APPADL]) questionnaire contains 7 items that assess how difficult it is for participants to engage in certain activities considered to be integral to normal daily life, such as walking, standing and climbing stairs. Items are scored on a 5-point numeric rating scale where 5 = not at all difficult and 1 = unable to do. The individual scores from all 7 items are summed and a single total score is calculated and may range between 7 and 35. A higher score indicates better ability to perform activities of daily living. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate."|Baseline, 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable APPADL data. Only pre-rescue measurements were used. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||units on a scale||Standard Error|Least Squares Mean
812324|NCT01064687|Secondary|Change From Baseline to 26 Weeks in the Impact of Weight on Activities of Daily Living|"The Impact of Weight on Activities of Daily Living (renamed the Ability to Perform Physical Activities of Daily Living [APPADL]) questionnaire contains 7 items that assess how difficult it is for participants to engage in certain activities considered to be integral to normal daily life, such as walking, standing and climbing stairs. Items are scored on a 5-point numeric rating scale where 5 = not at all difficult and 1 = unable to do. The individual scores from all 7 items are summed and a single total score is calculated and may range between 7 and 35. A higher score indicates better ability to perform activities of daily living. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate."|Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable APPADL data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||units on a scale||Standard Error|Least Squares Mean
812325|NCT01064687|Secondary|Change From Baseline to 52 Weeks in the Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) and Change (DTSQc) Versions|The Diabetes Treatment Satisfaction Questionnaire status (DTSQs) and change (DTSQc) versions are used to assess participant treatment satisfaction at each study visit and relative change in satisfaction from baseline, respectively. Both questionnaires consist of 8 items, 6 of which (1, and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale. The change version has the same 8 items as the status version with a small alteration of the wording of Item 7. Scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from 0 (very dissatisfied) to 36 (very satisfied) for the DTSQs and from -18 (much less satisfied) to +18 (much more satisfied) for the DTSQc. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline score as a covariate.|Baseline, 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable DTSQs or DTSQc data. Only pre-rescue measurements were used. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||units on a scale||Standard Error|Least Squares Mean
812326|NCT01064687|Secondary|Change From Baseline to 26 Weeks in the Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) Version|The Diabetes Treatment Satisfaction Questionnaire status version (DTSQs) is used to assess participant treatment satisfaction at each study visit. The questionnaire consists of 8 items, 6 of which (1, and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale. Scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from 0 (very dissatisfied) to 36 (very satisfied). The DTSQ change version (DTSQc) was not collected at 26 weeks. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline score as a covariate.|Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable DTSQs data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) used to impute missing postbaseline values. If there were no data after randomization, endpoint was considered missing.||units on a scale||Standard Error|Least Squares Mean
812335|NCT01064687|Secondary|Change From Baseline to 52 Weeks on Body Mass Index (BMI)|Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable BMI data. Only pre-rescue measurements were used.||kilograms per meter squared (kg/m^2)||Standard Error|Least Squares Mean
812336|NCT01064687|Secondary|Change From Baseline to 26 Weeks on Body Mass Index (BMI)|Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable BMI data. Only pre-rescue measurements were used.||kilograms per meter squared (kg/m^2)||Standard Error|Least Squares Mean
812327|NCT01064687|Secondary|Change From Baseline to 52 Weeks in the EuroQol 5|The European Quality of Life - 5 dimensions (EQ-5D) questionnaire is a generic, multidimensional, health-related, quality-of-life instrument. It consists of 2 parts: the first part assesses 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that have 3 possible levels of response (no problem, some problem, or extreme problem). These dimensions are converted into a weighted health-state Index Score. The EQ-5D United Kingdom (UK) score ranges from -0.59 to 1.0, where a score of 1.0 indicates perfect health and negative values are valued as worse than dead. The second part of the questionnaire consists of a visual analog scale (VAS) on which the participants rated their perceived health state on that day from 0 (worst imaginable health state) to 100 (best imaginable health). Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) and adjusted by treatment, country, and baseline.|Baseline, 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable EQ-5D data. Only pre-rescue measurements were used. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||units on a scale||Standard Error|Least Squares Mean
812328|NCT01064687|Secondary|Change From Baseline to 26 Weeks in the EuroQol 5|The European Quality of Life - 5 dimensions (EQ-5D) questionnaire is a generic, multidimensional, health-related, quality-of-life instrument. It consists of 2 parts: the first part assesses 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that have 3 possible levels of response (no problem, some problem, or extreme problem). These dimensions are converted into a weighted health-state Index Score. The EQ-5D United Kingdom (UK) score ranges from -0.59 to 1.0, where a score of 1.0 indicates perfect health and negative values are valued as worse than dead. The second part of the questionnaire consists of a visual analog scale (VAS) on which the participants rated their perceived health state on that day from 0 (worst imaginable health state) to 100 (best imaginable health). Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) and adjusted by treatment, country, and baseline.|Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable EQ-5D data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||units on a scale||Standard Error|Least Squares Mean
812329|NCT01064687|Secondary|Change From Baseline to 52 Weeks in Updated Homeostasis Model Assessment of Beta-cell Function (HOMA2-%B) and Updated Homeostasis Model Assessment of Insulin Sensitivity (HOMA2-%S)|The homeostatic model assessment (HOMA) quantifies insulin resistance and beta-cell function. HOMA2-B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady-state beta cell function (%B) as a percentage of a normal reference population (normal young adults). HOMA2-S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S) as percentages of a normal reference population (normal young adults). The normal reference populations were set at 100%. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable HOMA2-%B or HOMA2-%S data. Only pre-rescue measurements were used.||percentage of HOMA2||Standard Error|Least Squares Mean
812330|NCT01064687|Secondary|Change From Baseline to 26 Weeks in Updated Homeostasis Model Assessment of Beta-cell Function (HOMA2-%B) and Updated Homeostasis Model Assessment of Insulin Sensitivity (HOMA2-%S)|The homeostatic model assessment (HOMA) quantifies insulin resistance and beta-cell function. HOMA2-B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady-state beta cell function (%B) as a percentage of a normal reference population (normal young adults). HOMA2-S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S) as percentages of a normal reference population (normal young adults). The normal reference populations were set at 100%. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable HOMA2-%B or HOMA2-%S data. Only pre-rescue measurements were used.||percentage of HOMA2||Standard Error|Least Squares Mean
812331|NCT01064687|Secondary|Percentage of Participants Attaining Glycosylated Hemoglobin (HbA1c) Less Than 7% and Less Than or Equal to 6.5% at 52 Weeks|The percentage of participants achieving HbA1c level less than 7.0% and less than or equal to 6.5% was analyzed with a logistic regression model with baseline, country, and treatment as factors included in the model.|Baseline, 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable HbA1c data. Only pre-rescue measurements were used. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||percentage of participants|||Number
812332|NCT01064687|Secondary|Percentage of Participants Attaining Glycosylated Hemoglobin (HbA1c) Less Than 7% and Less Than or Equal to 6.5% at 26 Weeks|The percentage of participants achieving HbA1c level less than 7.0% and less than or equal to 6.5% was analyzed with a logistic regression model with baseline, country, and treatment as factors included in the model.|Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable HbA1c data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||percentage of participants|||Number
812333|NCT01064687|Secondary|Change From Baseline to 52 Weeks for Daily Mean Blood Glucose Values From the 8-point Self-monitored Plasma Glucose (SMPG) Profiles|The SMPG data were collected at the following 8 time points: pre-morning meal; 2 hours post-morning meal; pre-midday meal; 2 hours post-midday meal; pre-evening; 2 hours post-evening meal; bedtime; and 3AM or 5 hours after bedtime. Least squares (LS) means of the mean of the 8 time points (daily mean) were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, country, visit, and treatment-by-visit as fixed effects and baseline as a covariate.|Baseline, 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable SMPG data. Only pre-rescue measurements were used.||milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
812337|NCT01064687|Secondary|Change From Baseline to 52 Weeks for Body Weight|Least squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, country, visit, and treatment-by-visit as fixed effects and baseline as a covariate.|Baseline, 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable body weight data. Only pre-rescue measurements were used.||kilograms (kg)||Standard Error|Least Squares Mean
812338|NCT01064687|Secondary|Change From Baseline to 26 Weeks for Body Weight|Least squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, country, visit, and treatment-by-visit as fixed effects and baseline as a covariate.|Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable body weight data. Only pre-rescue measurements were used.||kilograms (kg)||Standard Error|Least Squares Mean
812339|NCT01064687|Secondary|Change From Baseline to 52 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c)|Least squares (LS) means were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline HbA1c as a covariate.|Baseline, 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable HbA1c data. Only pre-rescue measurements were used. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
812340|NCT01064687|Primary|Change From Baseline to 26 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c)|Least squares (LS) means were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline HbA1c as a covariate.|Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable HbA1c data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
812341|NCT01064739|Secondary|Urinary Sodium|urinary sodium 8-12 hours after breakfast|8-12 hours after breakfast|||mEq/4hr||Standard Deviation|Mean
812342|NCT01064739|Secondary|Urinary Sodium|Urinary sodium excreted 0-4 hours after breakfast.|0-4 hours after breakfast|||mEq/4hr||Standard Deviation|Mean
812343|NCT01064739|Secondary|Supine Heart Rate|Supine heart rate 6 hours after breakfast|6 hours after breakfast|||beats per minute||Standard Deviation|Mean
812344|NCT01064739|Secondary|Supine Systolic Blood Pressure|Supine systolic blood pressure 6 hours after breakfast|Supine-6 hours after breakfast on both study days.|||mm Hg||Standard Deviation|Mean
812345|NCT01064739|Secondary|Urinary Norepinephrine|Urinary norepinephrine excreted 8-12 hours after breakfast|8 to 12 hours after breakfast|||micrograms/4hr||Standard Deviation|Mean
812346|NCT01064739|Secondary|Urinary Norepinephrine|Urinary norepinephrine excreted 4-8 hours after breakfast|4 to 8 hours after breakfast|||micrograms/4hr||Standard Deviation|Mean
812347|NCT01064739|Secondary|Urinary Norepinephrine|Urinary norepinephrine excreted 0-4 hours after breakfast|0 to 4 hours after breakfast|||micrograms/4 hours||Standard Deviation|Mean
812348|NCT01064739|Secondary|Urinary Dopamine|Urinary dopamine excreted 8 to 12 hours after breakfast|8 to 12 hours after breakfast|||micrograms/4hr||Standard Deviation|Mean
812349|NCT01064739|Secondary|Urinary Dopamine|Urinary dopamine excreted 4 to 8 hours after breakfast|4 to 8 hours after breakfast|||micrograms/4 hours||Standard Deviation|Mean
812350|NCT01064739|Secondary|Urinary Dopamine|Urinary dopamine excreted 0 to 4 hours after breakfast|0 to 4 hours after breakfast|||micrograms/4hr||Standard Deviation|Mean
812351|NCT01064739|Secondary|Urinary Dopa|Urinary dopa excreted 4-8 hours after breakfast was specified as a primary outcome. Other time points (0-4 hr, 8-12 hr after breakfast) are non-primary outcomes.|8-12 hours after breakfast|||micrograms/4hr||Standard Deviation|Mean
812352|NCT01064739|Secondary|Urinary Dopa|Urinary dopa excreted 4-8 hours after breakfast was specified as a primary outcome. Other time points (0-4 hr, 8-12 hr after breakfast) are non-primary outcomes.|0-4 hours after breakfast|||ug/4hr||Standard Deviation|Mean
812353|NCT01064739|Secondary|Plasma Dopamine|Plasma dopamine 6 hours after breakfast|Plasma samplesPlasma dopamine 6 hours after breakfast on both study days.|||pg/mL||Standard Deviation|Mean
812354|NCT01064739|Secondary|Plasma Dopamine|Plasma dopamine 4 hours after breakfast|4 hours after breakfast on both study days.|||pg/mL||Standard Deviation|Mean
812355|NCT01064739|Secondary|Plasma Dopamine|Plasma dopamine 2 hours after breakfast|2 hours after breakfast on both study days.|||pg/mL||Standard Deviation|Mean
812356|NCT01064739|Secondary|Plasma Dopamine|Plasma dopamine 1 hour after breakfast|1 hour after breakfast|||pg/mL||Standard Deviation|Mean
812357|NCT01064739|Secondary|Plasma Norepinephrine|Plasma norepinephrine 6 hours after breakfast|6 hours after breakfast on both study days.|||pg/mL||Standard Deviation|Mean
812358|NCT01064739|Secondary|Plasma Norepinephrine|Plasma norepinephrine 4 hours after breakfast|4 hours after breakfast on both study days.|||pg/mL||Standard Deviation|Mean
812359|NCT01064739|Secondary|Plasma Norepinephrine|Plasma norepinephrine 2 hours after breakfast|2 hours after breakfast on both study days.|||pg/mL||Standard Deviation|Mean
812360|NCT01064739|Secondary|Plasma Norepinephrine|Plasma norepinephrine 1 hour after breakfast|1 hour after breakfast on both study days.|||pg/mL||Standard Deviation|Mean
812361|NCT01064739|Secondary|Plasma Dopa 6 Hrs After Breakfast|Subjects consumed the standard fixed sodium diet for at least two days prior to study and on study day one during an inpatient stay in the Vanderbilt Clinical Research Center. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr). Blood was sampled for catechol assays before and at 1, 2, 4 and 6 hours after breakfast. Plasma dopa 1 hour after breakfast was specified as a primary outcome. Other catechols (dihydroxyphenylglycol, norepinephrine, epinephrine, dopamine, dihydroxyphenylacetic acid) and other time points (2, 3, 4, 6hr after breakfast) are non-primary outcomes.|Plasma samples collected 6 hours after breakfast on both study days.|||pg/mL||Standard Deviation|Mean
812362|NCT01064739|Primary|Urinary Sodium|Urinary sodium excreted 4-8 hours after breakfast was designated as a primary outcome. Other urine samples (0-4 hr, 8-12 hr after breakfast) are considered as non-primary outcomes.|4 to 8 hours after breakfast|||mEq/4 hr||Standard Deviation|Mean
812364|NCT01064739|Secondary|Plasma Dopa 4 Hrs After Breakfast|Subjects consumed the standard fixed sodium diet for at least two days prior to study and on study day one during an inpatient stay in the Vanderbilt Clinical Research Center. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr). Blood was sampled for catechol assays before and at 1, 2, 4 and 6 hours after breakfast. Plasma dopa 1 hour after breakfast was specified as a primary outcome. Other catechols (dihydroxyphenylglycol, norepinephrine, epinephrine, dopamine, dihydroxyphenylacetic acid) and other time points (2, 3, 4, 6hr after breakfast) are non-primary outcomes.|Plasma samples collected 4 hours after breakfast on both study days.|||pg/mL||Standard Deviation|Mean
812365|NCT01064739|Secondary|Plasma Dopa 2 Hrs After Breakfast|Subjects consumed the standard fixed sodium diet for at least two days prior to study and on study day one during an inpatient stay in the Vanderbilt Clinical Research Center. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr). Blood was sampled for catechol assays before and at 1, 2, 4 and 6 hours after breakfast. Plasma dopa 1 hour after breakfast was specified as a primary outcome. Other catechols (dihydroxyphenylglycol, norepinephrine, epinephrine, dopamine, dihydroxyphenylacetic acid) and other time points (2, 3, 4, 6hr after breakfast) are non-primary outcomes.|Plasma samples collected 2 hours after breakfast on both study days.|||pg/mL||Standard Deviation|Mean
812366|NCT01064739|Primary|Plasma Dopa 1 hr After Breakfast|Subjects consumed the standard fixed sodium diet for at least two days prior to study and on study day one during an inpatient stay in the Vanderbilt Clinical Research Center. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr). Blood was sampled for catechol assays before and at 1, 2, 4 and 6 hours after breakfast. Plasma dopa 1 hour after breakfast was specified as a primary outcome. Other catechols (dihydroxyphenylglycol, norepinephrine, epinephrine, dopamine, dihydroxyphenylacetic acid) and other time points (2, 3, 4, 6hr after breakfast) are non-primary outcomes.|Plasma samples collected 1 hour after breakfast on both study days.|||pg/mL||Standard Deviation|Mean
812367|NCT01064817|Primary|Subjects With Safety Related Events or Findings|The number of Subjects with AEs, TEAEs, SAEs, decreased visual acuity, and worsened visual fields|First injection through end of study for AEs, SAEs, visual acuity and visual fields, and from first injection through Day 30 for TEAEs|||participants|||Number
812368|NCT01064817|Other Pre-specified|Bleb Scarring|Exploratory Efficacy Outcome measure: Bleb scarring is graded on a scale from 0-3. 0= none to minimal scarring, 1= mild, 2= moderate, 3= severe scarring.|Day 120|Number of subjects who had assessment of bleb scarring on Day 120||units on a scale||Standard Deviation|Mean
812369|NCT01064817|Other Pre-specified|Successful Intra-ocular Pressure (IOP) Control|Exploratory efficacy outcome measure. Successful IOP control defined as IOP between 6 and 18 mm Hg or 25% reduction from pre-surgical IOP|Day 120|||participants|||Number
812370|NCT01064817|Primary|Safety of Subconjunctival Injection|Number of adverse events (AEs), treatment emergent adverse events (TEAEs), non-ocular TEAEs, Ocular TEAEs, serious adverse events (SAEs), abnormal slit-lamp biomicroscopic findings, and abnormal dilated fundoscopy findings|AEs, slit-lamp, and fundoscopy findings from first injection through end of study; TEAEs from first injection through Day 30|All subjects enrolled in study; all subjects received all study treatment||Number of occurrences|||Number
812371|NCT01064830|Secondary|Patients Assessment of Satisfaction With Length of Fingernails|"the percentages of participants who were satisfied with the length of fingernails"|20 weeks|all patients enrolled who completed this response measure at week 20.||percentage of patients|||Number
812372|NCT01064830|Primary|• Number of Patients Receiving at Least a 1-grade Improvement in the Physicians Global Improvement Assessment (PGIA) of Two Target Nails.|IN a scale of 0-3 where 0 means normal nail and 3 means severe disease, the number of patients who received at least a decrease of 1 grade in the evaluation of two target nails|20 weeks|||patients|||Number
812373|NCT01064856|Secondary|Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 12|The ASDAS is a continuous disease activity score: low score indicates lower disease activity and higher values indicate higher disease activity. The score ranges from 0 to no defined upper limit. It is categorized into 4 disease activity states based on score: inactive disease (< 1.3), moderate (≥ 1.3 to < 2.1), high (≥ 2.1 to ≤ 3.5), and very high (> 3.5). Clinically important and major improvements in ASDAS are defined as a reduction from Baseline of ≥ 1.1 and ≥ 2.0 points, respectively. Participants with non-missing Baseline and at least 1 non-missing post-Baseline value were included in post-Baseline visits. LOCF: missing value was imputed using the last non-missing post-Baseline value prior to missing value.|Baseline (last measurement prior to first DB dose), Week 12|Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug and with non-missing values for both Baseline and post-baseline visit.||units on a scale||Standard Deviation|Mean
812374|NCT01064856|Secondary|Change From Baseline in Swollen Joint Count (SJC) at Week 12|Seventy-six joints were assessed for swelling by physical examination. Swelling of each joint was classified as present (1) or absent (0), for a total possible score SJC of 0 (0 joints with swelling) to 76 (worst possible score/76 joints with swelling). Participants with non-missing Baseline and at least 1 non-missing post-Baseline value were included in post-Baseline visits. LOCF: missing value was imputed using the last non-missing post-Baseline value prior to missing value.|Baseline (last measurement prior to first DB dose), Week 12|Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug.||units on a scale||Standard Deviation|Mean
812375|NCT01064856|Secondary|Change From Baseline in Tender Joint Count (TJC) at Week 12|Seventy-eight joints were assessed for tenderness by physical examination. Tenderness of each joint was classified as present (1) or absent (0), for a total possible TJC score of 0 (0 joints with tenderness) to 78 (worst possible score/78 joints with tenderness). Participants with non-missing Baseline and at least 1 non-missing post-Baseline value were included in post-Baseline visits. LOCF: missing value was imputed using the last non-missing post-Baseline value prior to missing value.|Baseline (last measurement prior to first DB dose), Week 12|Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug.||units on a scale||Standard Deviation|Mean
812480|NCT01071915|Secondary|Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight|This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value.|To Day 196|Safety analyis population||participants|||Number
812376|NCT01064856|Secondary|Change From Baseline in Dactylitis at Week 12|Assessment of the presence or absence of dactylitis as well as grading of tenderness and swelling in all 20 of the participants' digits was performed. Tenderness at each site was quantified from absent to severe. Swelling was quantified from mild to severe. Total Dactylitis Assessment scores ranging from 0 (no digits with dactylitis) to 20 (worst possible score; 20 digits with dactylitis). Participants with non-missing Baseline and at least 1 non-missing post-Baseline value were included in post-Baseline visits. LOCF: missing value was imputed using the last non-missing post-Baseline value prior to missing value.|Baseline (last measurement prior to first DB dose), Week 12|Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug and had non-missing values for both Baseline and the post-baseline.||units on a scale||Standard Deviation|Mean
812377|NCT01064856|Secondary|Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Score at Week 12|Assessment of enthesitis was performed in the following 16 domains: left and right (L/R) medial epicondyle; L/R lateral epicondyle; L/R supraspinatus insertion into the greater tuberosity of humerus; L/R greater trochanter; L/R quadriceps insertion into superior border of patella; L/R patellar ligament insertion into inferior pole of patella or tibial tubercle; L/R Achilles tendon insertion into calcaneum; L/R plantar fascia insertion into calcaneum. Tenderness at each site was quantified on a dichotomous basis. Each domain was graded for the presence (1) and absence (0) of tenderness yielding total SPARCC scores ranging from 0 (0 sites with tenderness) to 16 (worst possible score; 16 sites with tenderness). Participants with non-missing Baseline and at least 1 non-missing post-Baseline value were included in post-Baseline visits. LOCF: missing value was imputed using the last non-missing post-Baseline value prior to missing value.|Baseline (last measurement prior to first DB dose), Week 12|Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug.||units on a scale||Standard Deviation|Mean
812378|NCT01064856|Secondary|Change From Baseline in Leeds Enthesitis Index at Week 12|Assessment of enthesitis was performed in the following 6 domains: left and right lateral epicondyle, left and right medial femoral condyle, left and right Achilles tendon insertion. Tenderness at each site was quantified on a dichotomous basis: Each domain was graded for the presence (1) and absence (0) of tenderness yielding total Leeds Enthesitis Index scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). Participants with non-missing Baseline and at least 1 non-missing post-Baseline value were included in post-Baseline visits. LOCF: missing value was imputed using the last non-missing post-Baseline value prior to missing value.|Baseline (last measurement prior to first DB dose), Week 12|Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug.||units on a scale||Standard Deviation|Mean
812379|NCT01064856|Secondary|Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 12|Assessment of enthesitis was performed in the following 7 domains: 1) 1st costochondral joint left and right, 2) 7th costochondral joint left and right, 3) posterior superior iliac spine left and right, 4) anterior superior iliac spine left and right, 5) iliac crest left and right, 6) 5th lumbar spinous process and 7) proximal insertion of Achilles tendon left and right. Each domain was graded for the presence (1) or absence (0) of tenderness yielding total MASES ranging from 0 (0 sites with tenderness) to 13 (worst possible score; 13 sites with tenderness). Participants with non-missing Baseline and at least 1 non-missing post-Baseline value were included in post-Baseline visits. LOCF: missing value was imputed using the last non-missing post-Baseline value prior to missing value.|Baseline (last measurement prior to first DB dose), Week 12|Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug.||units on a scale||Standard Deviation|Mean
812380|NCT01064856|Secondary|Change From Baseline in Short Form-36 Health Status Survey™ Version 2 (SF-36™V2) Physical Component Score (PCS) at Week 12|The Short Form-36 Health Status Survey™ Version 2 (SF-36™V2) is a 36-item generic health-related quality of life measure to assess the participant's view of their health consisting of 2 components: physical and mental. For each component, a transformed summary score is calculated using 8 sub-domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores range from 0 to 100. Higher scores indicate a better health state.|Baseline (last measurement prior to first DB dose), Week 12|Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug and had non-missing values.||units on a scale||Standard Deviation|Mean
812381|NCT01064856|Secondary|Change From Baseline in Health Assessment Questionnaire Modified for the Spondyloarthropathies (HAQ-S) Total at Week 12|The HAQ-S is a self-reported measure to assess the physical function and health-related quality of life. The Disability Index (DI) of HAQ-S is calculated as the mean of the following 8 category scores (range: 0 [without any difficulty] to 3 [unable to do]): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Five additional items in the functional status measure were included in the HAQ-S, including carrying heavy packages, sitting for long periods, able to work at a flat topped table, and (if the participant had a driver's license or a car) able to look in the rear view mirror and able to turn head to drive in reverse. The overall score ranges from 0 (no disability) to 3 (three very severe, high-dependency disability). Negative mean changes from Baseline in the overall score indicate improvement. LOCF: Missing value was imputed using the last non-missing post-baseline value prior to missing value.|Baseline (last measurement prior to first DB dose), Week 12|Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug.||units on a scale||Standard Deviation|Mean
812382|NCT01064856|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 12|The BASDAI was to be completed at the designated study visits. The participant was to assess his/her disease activity using the BASDAI which consisted of a VAS scale used to answer 6 questions (Q1 through Q6) pertaining to symptoms experienced by the participant for the past week. Each question on the BASDAI was reported in centimeters (0 [none] to 10 [very severe] with one question's possible answers being in time increments [0 hours to ≥ 2 hours]). The overall BASDAI score ranges from 0 to 10 cm and was calculated as follows: BASDAI Score = 0.2 × (Q1 + Q2 + Q3 + Q4 + Q5/2 + Q6/2). Lower scores indicate less disease activity. LOCF: Missing value was imputed using the last non-missing post-baseline value prior to missing value.|Baseline (last measurement prior to first DB dose), Week 12|Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug.||units on a scale||Standard Deviation|Mean
812383|NCT01064856|Secondary|Change From Baseline in Physician Global Assessment (PGA) of Disease Activity at Week 12|A VAS was to be used for the Physician Global Assessment (PGA) of disease activity (current status). The left end of the VAS scale (0 mm) signifies the absence of symptoms and the right end (100 mm) signifies maximum disease activity. Last observation carried forward (LOCF): missing values were imputed using the last non-missing post-baseline value prior to the missing value.|Baseline (last measurement prior to first DB dose), Week 12|Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug.||units on a scale||Standard Deviation|Mean
812384|NCT01064856|Primary|Number of Participants With Adverse Events|An adverse event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with treatment. If an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE): results in death or is life-threatening, results in admission or prolongation of hospitalization, results in congenital anomaly or persistent or significant disability/incapacity, or is an important medical event requiring medical or surgical intervention to prevent serious outcome. AEs were categorized by severity (mild, moderate, severe) and relationship to treatment (probably, possibly, probably not, not related). Please see Adverse Events section below for more details.|Baseline (day of first study drug administration) through Week 156 plus 70 days|Safety Analyses included all participants who received at least 1 dose of double-blind study drug.||participants|||Number
812385|NCT01064856|Primary|Percentage of Responders According to the Composite Peripheral SpA Response Criteria (PSpARC 40) at Week 12|Percentage of participants achieving the following composite response at Week 12: >= 40% improvement (minimum 20 mm absolute improvement) from Baseline in Patient Global Assessment (PTGA) of Disease Activity as measured by a 100 mm visual analogue scale (VAS) where 0=no symptoms and 100=maximum symptoms; >= 40% improvement (minimum 20 mm absolute improvement) from Baseline in PTGA – Pain as measured by a 100 mm VAS where 0=no pain and 100=maximum pain; and >= 40% improvement from Baseline in at least 1 of the following 3 criteria: swollen joint count (76 joints) and tender joint count (78 joints); total enthesitis count; or total dactylitis count. Non-responder imputation: missing response was imputed as non-response.|Week 12|Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug (ITT).||percentage of participants|||Number
812386|NCT01064882|Secondary|Treatment Satisfaction Questionnaire Score at Month 3|The Treatment Satisfaction Questionnaire at Month 3 consisted of 2 questions that collected information regarding subject satisfaction with the treatment overall. The questions assessed the likelihood that the subject would use the product, as well as the likelihood that the subject would recommend the product to family and/or friends, if it were available. The score was based on the responses to each question. Questions were answered on a 5-point scale ranging from 1 (very unlikely = worst) to 5 (very likely = best).|Month 3|Modified Intent-to-Treat: All randomized subjects who were treated with the intended study medication and completed at least one follow-up visit.(Note: 2 subjects in the Bim 0.015% treatment group, 1 subject in the Bim 0.005% treatment group, and 1 subject in the Bim 0.03% treatment group did not have Month 3 visit data for this outcome measure)||Scores on a Scale||Standard Deviation|Mean
812387|NCT01064882|Secondary|Change From Baseline in the Confidence, Attractiveness, and Professionalism (CAP) Domain Scores at Month 3|Change from baseline in the CAP domain at Month 3 included responses to questions 7, 8, and 9. Responses to each question ranged from 1 (very much disagree = worst) to 5 (very much agree = best) with the minimum sum of the scores for the domain equal to 3 and the maximum sum of the scores for the domain equal to 15. Domain responses at Month 3 were compared to baseline. Positive values at Month 3 indicated an improvement from baseline, and negative values indicated a worsening from baseline.|Baseline, Month 3|Modified Intent-to-Treat: All randomized (started study) subjects who were treated with the intended study medication and completed at least one follow-up visit.||Scores on a Scale||Standard Deviation|Mean
812388|NCT01064882|Secondary|Change From Baseline in Overall Eyelash Satisfaction at Month 3|"Change from baseline at Month 3 in question 3 overall, how satisfied are you with your eyelashes? Responses ranged from 1 (very unsatisfied = worst) to 5 (very satisfied = best). Individual responses at Month 3 were compared to baseline. Positive values at Month 3 indicated an improvement from baseline, and negative values indicated a worsening from baseline."|Baseline, Month 3|Modified Intent-to-Treat: All randomized (started study) subjects who were treated with the intended study medication and completed at least one follow-up visit.||Scores on a Scale||Standard Deviation|Mean
812389|NCT01064882|Secondary|Percentage of Subjects With a Clinical Response in Overall Eyelash Prominence on the Global Eyelash Assessment (GEA) at Month 3|Percentage of subjects with a clinical response in overall eyelash prominence at Month 3 was measured using a 4-point GEA scale with the aid of the photonumeric guide. The scale ranges from 1 (minimal = worst) prominence to 4 (very marked = best)prominence. Eyelash prominence was assessed and graded by the investigator over both eyes. A clinical response was defined as at least a 1-grade increase in GEA score from baseline to Month 3.|Month 3|Modified Intent-to-Treat: All randomized (started study) subjects who were treated with the intended study medication and completed at least one follow-up visit.||Percentage of Subjects|||Number
812390|NCT01064882|Secondary|Change From Baseline in Upper Eyelash Darkness (in Intensity Units) at Month 3|Change from baseline in upper eyelash darkness at Month 3 was determined by lash intensity within the spline (a narrow area approximately 5 pixels wide that bisects the area of interest). Upper eyelash darkness was measured in both eyes and averaged for analysis. Colors ranged from black=0 to white=255. Lower numbers on this continuum indicated darker colors. Therefore, a change from baseline to Month 3 represented by a negative value indicated increased eyelash darkening.|Baseline, Month 3|Modified Intent-to-Treat: All randomized (started study) subjects who were treated with the intended study medication and completed at least one follow-up visit. (Note that 2 subjects in the Bim 0.015% treatment group did not have baseline or Month 3 visit data for this outcome measure.)||Units on a Scale||Standard Deviation|Mean
812405|NCT01065051|Secondary|Change in Left Ventricular Ejection Fraction (LVEF) at Rest|The left ventricular ejection fraction work index (LVEF) is a calculated echocardiography parameter. LVEF is derived from the directly measured parameters left ventricular end-diastolic volume (LVEDV) and left ventricular end-systolic volume (LVESV). These 2 parameters are acquired during a non-invasive echocardiography examination. Formula: LEVF = 100*(LVEDV - LVESV)/LVEDV|Before and 1 hour after administration of study drug|Due to the very low number of patients enrolled in the study, no statistical evaluation was done.|||||
812391|NCT01064882|Secondary|Change From Baseline in Upper Eyelash Thickness at Month 3|Change from baseline in upper eyelash thickness/fullness at Month 3 was measured within 3 preset areas. Eyelash thickness/fullness was assessed across both eyes as an average of the 3 preset areas measured in millimeters squared (mm^2). Changes from baseline to Month 3 represented by positive values indicated increased eyelash thickness, and changes from baseline represented by negative values indicated thinner eyelash thickness.|Baseline, Month 3|Modified Intent-to-Treat: All randomized (started study) subjects who were treated with the intended study medication and completed at least one follow-up visit. (Note that 2 subjects in the Bim 0.015% treatment group did not have baseline or Month 3 visit data for this outcome measure.)||Millimeters squared (mm^2)||Standard Deviation|Mean
812392|NCT01064882|Primary|Change From Baseline in Eyelash Length at Month 3|Change from Baseline at Month 3 in eyelash length, measured in millimeters (mm). Data from both eyes were averaged for each subject for analysis. Changes from baseline represented by positive values indicated longer length, and changes from baseline represented by negative values indicated shorter length.|Baseline, Month 3|Modified Intent-to-Treat: All randomized (started study) subjects who were treated with the intended study medication and completed at least one-follow-up visit. (Note that one subject in the Bim 0.015% treatment group did not have baseline or Month 3 visit data for this outcome measure.)||millimeters (mm)||Standard Deviation|Mean
812393|NCT01064947|Secondary|Local Tolerability|"The investigator assessed the following characteristics on a grading scale of 0-3 (none, mild moderate or severe): erythema, inflammation, infection, crusting, necrosis, peeling, swelling and contact dermatitis.
The subject assessed the following characteristics on a scale of 0-3 (none, mild, moderate or severe): irritation, itchiness burning, tenderness and pain."|Day 7|||units on a scale||Inter-Quartile Range|Median
812394|NCT01064947|Secondary|Investigator Assessment of Clinical Cure|The investigator assessed clinical cure at Day 7 as either total or improved cure, failure confirmed or failure by default|Day 7|||participants|||Number
812395|NCT01064947|Secondary|Skin Infection Rating Scale (SIRS)|The Primary Investigator rated the each of the following characteristics: exudate/pus, crusting, erythema/inflammation, tissue warmth, tissue edema, itching and pain on a scale of 0-6 (absent-severe) to create an overall SIRS score ranging from 0-42.|Day 1 and Day 7|||units on a scale||Inter-Quartile Range|Median
812396|NCT01064947|Primary|Bacteriological Culture|All participants were cultured for S.aureus (MRSA), S.aureus (MSSA) and S. pyogenes at Baseline. If positive at Baseline then they were cultured again at Day 7.|Day 1 and Day 7|||participants|||Number
812397|NCT01065051|Secondary|Change in the Ventilatory Efficiency (V’E/V’CO2) Measured From Baseline to the Anaerobic Threshold (AT) During the Cardiopulmonary Exercise Tests (CPET)|Ventilatory efficiency (V’E/V’CO2) and anaerobic threshold (AT) were parameters directly measured or derived by computed analysis from the spiroergometry system during the cardiopulmonary exercise test.|Before and 1 hour after administration of study drug|Due to the very low number of patients enrolled in the study, no statistical evaluation was done.|||||
812398|NCT01065051|Secondary|Change in the Slope of the Relationship Between Work Rate and Mean Pulmonary Arterial Pressure (PAPmean) During the Cardiopulmonary Exercise Tests|The slope of the relationship between work rate during cardiopulmonary exercise tests and PAPmean is derived from the directly measured hemodynamic parameter mean pulmonary arterial pressure (PAPmean). PAPmean is acquired during a right heart catheterization.|Before and 1 hour after administration of study drug|Due to the very low number of patients enrolled in the study, no statistical evaluation was done.|||||
812399|NCT01065051|Secondary|Change in Lateral Mitral Annular Peak Early Diastolic Velocity (E’) During the Cardiopulmonary Exercise Tests|The lateral mitral annular peak early diastolic velocity (E’) is a measured echocardiography parameter. It is acquired during a non-invasive echocardiography examination.|Before and 1 hour after administration of study drug|Due to the very low number of patients enrolled in the study, no statistical evaluation was done.|||||
812400|NCT01065051|Secondary|Change in Tricuspid Annular Plane Systolic Excursion (TAPSE) During the Cardiopulmonary Exercise Tests|The tricuspid annular plane systolic excursion (TAPSE) is a measured echocardiography parameter. It is acquired during a non-invasive echocardiography examination.|Before and 1 hour after administration of study drug|Due to the very low number of patients enrolled in the study, no statistical evaluation was done.|||||
812401|NCT01065051|Secondary|Change in Peak Systolic Tricuspid Annular Velocity (RV-Sm) During the Cardiopulmonary Exercise Tests|The peak systolic tricuspid annular velocity (RV-Sm) is a measured echocardiography parameter. It is acquired during a non-invasive echocardiography examination.|Before and 1 hour after administration of study drug|Due to the very low number of patients enrolled in the study, no statistical evaluation was done.|||||
812402|NCT01065051|Secondary|Change in Lateral Mitral Annular Peak Systolic Velocity (Sm) During the Cardiopulmonary Exercise Tests|The lateral mitral annular peak systolic velocity (Sm) is a measured echocardiography parameter. It is acquired during a non-invasive echocardiography examination.|Before and 1 hour after administration of study drug|Due to the very low number of patients enrolled in the study, no statistical evaluation was done.|||||
812403|NCT01065051|Secondary|Change in Peak Power Index During the Cardiopulmonary Exercise Tests|The peak power index is a calculated hemodynamic parameter. It is derived from the directly measured parameters mean systolic arterial pressure (SAPmean) and mean pulmonary capillary wedge pressure (PCWPmean). These 2 parameters are acquired during a right heart catheterization. Formula: Peak Power Index = (SAPmean - PCWPmean)*CO*16.667/LVEDV|Before and 1 hour after administration of study drug|Due to the very low number of patients enrolled in the study, no statistical evaluation was done.|||||
812404|NCT01065051|Secondary|Change in End-systolic Elastance at Rest|The end-systolic elastance is a calculated hemodynamic parameter. It is approximated by the directly measured hemodynamic parameter end-systolic pressure divided by the directly measured echocardiography parameter left ventricular end-systolic volume (LVESV). The end-systolic pressure is acquired during a right heart catheterization. The LVESV is acquired during a non-invasive echocardiography examination. Approximated by end-systolic pressure/LVESV|Before and 1 hour after administration of study drug|Due to the very low number of patients enrolled in the study, no statistical evaluation was done.|||||
812443|NCT01070784|Secondary|Chronic Obstructive Pulmonary Disease (COPD) symptoms_cough|There are 5 alternatives (scored 0 to 4, 0= unaware of coughing, 4= never free of cough or need to cough). The change from Run-in period average to Treatment period average for each treatment group|Daily during run-in period and daily during 52-week randomization treatment|||units on a scale||Standard Deviation|Mean
812406|NCT01065051|Secondary|Change in Left Ventricular Stroke Work Index (LVSWI) at Rest|The left ventricular stroke work index (LVSWI) is a calculated hemodynamic parameter. It is derived from the directly measured parameters mean systolic arterial pressure (SAPmean) and mean pulmonary capillary wedge pressure (PCWPmean). These 2 parameters are acquired during a right heart catheterization. The LVSWI is also dependent of the calculated hemodynamic parameter stroke volume index (SVI). Formula: LVSWI = (SAPmean – PCWPmean)*SVI*0.0136|Before and 1 hour after administration of study drug|Due to the very low number of patients enrolled in the study, no statistical evaluation was done.|||||
812407|NCT01065051|Primary|Change in Peak Power Index at Rest|The peak power index is a calculated hemodynamic parameter. It is derived from the directly measured parameters mean systolic arterial pressure (SAPmean) and mean pulmonary capillary wedge pressure (PCWPmean). These 2 parameters are acquired during a right heart catheterization. The peak power index is calculated from the maximal power (which also takes the calculated parameter cardiac output into account) divided by the left ventricular end-diastolic volume (LVEDV). Formula: Peak Power Index = (SAPmean - PCWPmean)*CO [cardiac output]*16.667/LVEDV|Before and 1 hour after administration of study drug|Due to the very low number of patients enrolled in the study, no statistical evaluation was done.|||||
812408|NCT01070550|Secondary|Percentage of Participants With Predictive Values of Virological Response by Week 2 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Per-Protocol Population|The probability that a participant who developed VR by Wk 2 and also achieved mSVR at 24 weeks after EOT was called the PPV of the VR by Wk 2 for mSVR. The probability that a participant who failed to develop VR by Wk 2 and also failed to achieve mSVR at 24 weeks after EOT was called the NPV of the VR by Wk 2 for mSVR. Predictive values of VR are reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The PP population included all participants who met the inclusion/exclusion criteria.||Percentage of participants||95% Confidence Interval|Number
812409|NCT01070550|Secondary|Percentage of Participants With Predictive Values of Virological Response by Week 2 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Modified All-Treated Population|The probability that a participant who developed VR by Wk 2 also achieved mSVR at 24 weeks after EOT was called the PPV of the VR by Wk 2 for mSVR. The probability that a participant who failed to develop VR by Wk 2 and also failed to achieve mSVR at 24 weeks after EOT was called the NPV of the VR by Wk 2 for mSVR. Predictive Values of VR was reported in treatment naive HCV mono-infected mTRT population receiving PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN alfa-2a and ribavirin, and had at least one post-baseline HCV RNA test result. Participants with a baseline test result of <50 IU/mL were excluded from the mTRT population.||Percentage of participants||95% Confidence Interval|Number
812410|NCT01070550|Secondary|Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 24 Weeks After End of Treatment|Participants whose last test result in the follow-up time window showed mVR were considered to have maintained their mEOT-R. Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. The percentage of participants with relapse is reported in treatment naive PP population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The PP population included all participants who met the inclusion/exclusion criteria.||Percentage of participants|||Number
812411|NCT01070550|Secondary|Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 24 Weeks After End of Treatment|Participants whose last test result in the follow-up time window showed mVR were considered to have maintained their mEOT-R. Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. The percentage of participants with relapse was reported in treatment naive mTRT population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN alfa-2a and ribavirin, and had at least one post-baseline HCV RNA test result. Participants with a baseline test result of <50 IU/mL were excluded from the mTRT population.||Percentage of participants|||Number
812412|NCT01070550|Secondary|Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 12 Weeks After End of Treatment|Participants whose last test result in their respective follow-up time window showed mVR were considered to have maintained their mEOT-R. Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. The percentage of participants with relapse is reported in treatment naive PP population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 12 weeks after EOT|The PP population included all participants who met the inclusion/exclusion criteria.||Percentage of Participants|||Number
812444|NCT01070784|Secondary|Chronic Obstructive Pulmonary Disease (COPD) symptoms_Breathlessness|There are 5 alternatives (scored 0 to 4, 0= unaware of any difficulty and 4 =almost constant, present even when resting). The change from Run-in period average to Treatment period average for each treatment group|Daily during run-in period and daily during 52-week randomization treatment|||units on a scale||Standard Deviation|Mean
831860|NCT01243320|Primary|Change in Sodium Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days|||mmol/L||95% Confidence Interval|Mean
812413|NCT01070550|Secondary|Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 12 Weeks After End of Treatment|Participants whose last test result in their respective follow-up time window showed mVR were considered to have maintained their modified end of treatment response (mEOT-R). Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. The percentage of participants with relapse is reported in treatment naive mTRT population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 12 Weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN alfa-2a and ribavirin, and had at least one post-baseline HCV RNA test result. Participants with a baseline test result of <50 IU/mL were excluded from the mTRT population.||Percentage of participants|||Number
812414|NCT01070550|Secondary|Number of Participants With Response by Disjoint Categories by Genotype in Per-Protocol Population at Week 4 and Week 12|RVR defined was as VR by Week 4, mRVR was defined as mVR by Week 4, cEVR was defined as VR by Week 12, but no RVR, mcEVR was defined as mVR by Week 12, but no mRVR, pEVR was defined as at least a 2-log10 drop in HCV RNA as compared to baseline (including HCV RNA values <50 IU/mL) by Week 12, but no RVR and no cEVR, mpEVR was defined as at least a 2-log10 drop in HCV RNA as compared to baseline by Week 12, but no mRVR and no mcEVR. The data is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a.|At Week 4 and Week 12|The PP population included all participants who met the inclusion/exclusion criteria.||Participants|||Number
812415|NCT01070550|Secondary|Number of Participants With Response by Disjoint Categories by Genotype in Modified All-Treated Population at Week 4 and Week 12|Rapid virological response (RVR) was defined as VR by Week 4, Modified rapid virological response (mRVR) was defined as mVR by Week 4, Complete early virological response (cEVR) was defined as VR by Week 12, but no RVR, Modified complete early virological response (mcEVR) was defined as mVR by Week 12, but no mRVR, Partial early virological response (pEVR) was defined as at least a 2-log10 drop in HCV RNA as compared to baseline (including HCV RNA values <50 IU/mL) by, Week 12, but no RVR and no cEVR, Modified partial early virological response (mpEVR) was defined as at least a 2-log10 drop in HCV RNA as compared to baseline by Week 12, but no mRVR and no mcEVR. The data is reported in treatment naive HCV mono-infected mTRT participants who received PEG-IFN alfa-2a.|Week 4 and Week 12|The mTRT population included all participants who received at least one dose of PEG-IFN alfa-2a and ribavirin, and had at least one post-baseline HCV RNA test result. Participants with a baseline test result <50 IU/mL were excluded from the mTRT population.||Participants|||Number
812416|NCT01070550|Secondary|Percentage of Participants With At Least 1 Log Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Per-Protocol Population at Week 2, Week 4 and Week 12|Participants with 1-log drop in HCV RNA including HCV RNA values <50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 1- log drop in HCV RNA was defined as drop of HCV viral load by 90%. The 1- log drop in HCV RNA was reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a.|Week 2, Week 4, and Week 12|The PP population included all participants who met the inclusion/exclusion criteria.||Percentage of participants||95% Confidence Interval|Number
812417|NCT01070550|Secondary|Percentage of Participants With At Least 1-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Modified All-Treated Population at Week 2, Week 4 and Week 12|Participants with 1-log drop in HCV RNA including HCV RNA values <50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 1- log drop in HCV RNA was defined as drop of HCV viral load by 90%. The 1- log drop in HCV RNA was reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a.|Week 2, Week 4, and Week 12|The mTRT population included all participants who received at least one dose of PEG-IFN alfa-2a and ribavirin, and had at least one post-baseline HCV RNA test result. Participants with a baseline test result of <50 IU/mL were excluded from the mTRT population.||Percentage of participants||95% Confidence Interval|Number
812418|NCT01070550|Secondary|Percentage of Participants With At Least a 2-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Per-Protocol Population at Week 2, Week 4 and Week 12|Participants with 2-log drop in HCV RNA including HCV RNA values <50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 2 log drop in HCV RNA was defined as drop of HCV viral load by 99%. The 2 log drop in HCV RNA is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a.|Week 2, Week 4, and Week 12|The PP population included all participants who met the inclusion/exclusion criteria.||Percentage of participants||95% Confidence Interval|Number
812419|NCT01070550|Secondary|Percentage of Participants With At Least 2-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Modified All-Treated Population at Week 2, Week 4 and Week 12|Participants with 2-logarithm (log) drop in HCV RNA including HCV RNA values <50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 2 log drop in HCV RNA was defined as drop of HCV viral load by 99%. The 2 log drop in HCV RNA is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a.|At Week 2, Week 4, and Week 12|The mTRT population included all participants who received at least one dose of PEG-IFN alfa-2a and ribavirin, and had at least one post-baseline HCV RNA test result. Participants with a baseline test result of <50 IU/mL were excluded from the mTRT population.||Percentage of participants||95% Confidence Interval|Number
812445|NCT01070784|Secondary|Chronic Obstructive Pulmonary Disease (COPD) symptoms_Night-time Awakening|There are 5 alternatives (scored 0 to 4, 0= no awakening and 4 =did not sleep at all). The change from Run-in period average to Treatment period average for each treatment group|Daily during run-in period and daily during 52-week randomization treatment|||units on a scale||Standard Deviation|Mean
812446|NCT01070784|Primary|ECG Variables - RR Interval|Change from baseline|Baseline and 52 week after|||ms||Standard Deviation|Mean
812447|NCT01070784|Primary|ECG Variables - QTcF Interval|Change from baseline|Baseline and 52 week after|||ms||Standard Deviation|Mean
812420|NCT01070550|Secondary|Percentage of Participants With Modified Virological Response by Genotype in Per-Protocol Population Over Time|Modified virological response is defined as HCV RNA <50 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The mVR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At Week 2, Week 4, Week 12, EOT, and 12 weeks after EOT|The PP population included all participants who met the inclusion/exclusion criteria.||Percentage of participants||95% Confidence Interval|Number
812421|NCT01070550|Secondary|Percentage of Participants With Modified Virological Response by Genotype in Modified All-Treated Population Over Time|Modified virological response was defined as HCV RNA <50 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The mVR is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At Week 2, Week 4, Week 12, EOT, and 12 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN alfa-2a and ribavirin, and had at least one post-baseline HCV RNA test result. Participants with a baseline test result of <50 IU/mL were excluded from the mTRT population.||Percentage of participants||95% Confidence Interval|Number
812422|NCT01070550|Secondary|Percentage of Participants With Virological Response by Genotype in Per-Protocol Population Over Time|Virological response was defined as HCV RNA <15 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The VR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At Week 2, Week 4, Week 12, EOT, and 12 weeks after EOT|The PP population included all participants who met the inclusion/exclusion criteria.||Percentage of participants||95% Confidence Interval|Number
812423|NCT01070550|Secondary|Percentage of Participants With Virological Response by Genotype in Modified All-Treated Population Over Time|Virological response was defined as HCV RNA <15 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The VR is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At Week 2, Week 4, and Week 12, EOT, and 12 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN alfa-2a and ribavirin, and had at least one post-baseline HCV RNA test result. Participants with a baseline test result of <50 IU/mL were excluded from the mTRT population.||Percentage of participants||95% Confidence Interval|Number
812424|NCT01070550|Primary|Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Per-Protocol Population|The probability that a participant who developed VR by Week 4 and 12 and also achieved mSVR at 24 weeks after EOT was called the PPV of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 4 and 12 and also failed to achieve mSVR at 24 weeks after EOT was called the NPV of the VR by Wk 4 and 12 for mSVR. Predictive values of VR are reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The PP population included all participants who met the inclusion/exclusion criteria. n = the number of participants analyzed at a given time point.||Percentage of participants||95% Confidence Interval|Number
812425|NCT01070550|Primary|Percentage of Participants With Predictive Values of Virological Response by Week 4 and Week 12 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Modified All-Treated Population|The probability that a participant who developed VR by Week 4 and 12 and also achieved mSVR at 24 weeks after EOT was called the positive predictive value (PPV) of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 4 and 12 and also failed to achieve mSVR at 24 weeks after EOT was called the negative predictive value (NPV) of the VR by Wk 4 and 12 for mSVR. Predictive values of VR are reported in treatment naive HCV mono-infected mTRT participants who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN alfa-2a and ribavirin, and had at least one post-baseline HCV RNA test result. Participants with a baseline test result <50 IU/mL were excluded from the mTRT population. n = the number of participants analyzed at a given time point.||Percentage of participants||95% Confidence Interval|Number
812426|NCT01070550|Primary|Percentage of Participants With Modified Sustained Virological Response by Genotype in Per-Protocol Population|Modified sustained virological response is defined as mVR of HCV RNA <50 IU/mL at 24 weeks after EOT. The mSVR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The PP population included all participants who met the inclusion/exclusion criteria.||Percentage of participants||95% Confidence Interval|Number
812427|NCT01070550|Primary|Percentage of Participants With Modified Sustained Virological Response by Genotype in Modified All-Treated Population|Modified sustained virological response (mSVR) was defined as modified virological response (mVR) of HCV RNA <50 IU/mL at 24 weeks after EOT. The mSVR is reported in treatment naive HCV mono-infected mTRT who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN alfa-2a and ribavirin, and had at least one post-baseline HCV RNA test result. Participants with a baseline test result of <50 IU/mL were excluded from the mTRT population.||Percentage of participants||95% Confidence Interval|Number
812448|NCT01070784|Primary|ECG Variables - QTcB Interval|Change from baseline|Baseline and 52 week after|||ms||Standard Deviation|Mean
812428|NCT01070550|Primary|Percentage of Participants With Sustained Virological Response by Genotype in Per-Protocol Population|Sustained virological response was defined as VR at 24 weeks after EOT. Virological response was defined as HCV RNA of <15 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The SVR is reported in treatment naive HCV mono-infected per protocol (PP) population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The PP population included all participants who met the inclusion/exclusion criteria.||Percentage of participants||95% Confidence Interval|Number
812429|NCT01070550|Primary|Percentage of Participants With Sustained Virological Response by Genotype in Modified All Treated Population|Sustained virological response (SVR) was defined as virological response (VR) at 24 weeks after end of treatment (EOT). Virological response was defined as hepatitis C virus ribonucleic acid (HCV RNA) of <15 international units per milliliter (IU/mL) as assessed by COBAS AmpliPrep/COBAS TaqMan (CAP/CTM) or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (lower limit of detection [LLOD] 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The SVR is reported in treatment naive hepatitis C virus (HCV) mono-infected modified all-treated (mTRT) who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The mTRT population included all participants who received at least one dose of peginterferon alfa-2a and ribavirin, and had at least one post-baseline HCV RNA test result. Participants with a baseline test result <50 IU/mL were excluded from the mTRT population.||Percentage of participants||95% Confidence Interval|Number
812430|NCT01070693|Primary|Long-term Sequelae|Any pain at five years|5 years|||percentage of participants|||Number
812431|NCT01070771|Secondary|To Determine the Level of Agreement in Management Plans Regarding the Significance of Coronary Artery Narrowings When Comparing the MP Acquired by Standard Angiographic Assessment Alone and a MP Acquired Using Angiographic Assessment Plus FFR Data.|"This compared the number of vessels in which there was a discrepant result in relation to angiographically and FFR defined significance. Angiographic significance was visually assessed by operators whereas the pressure wire provided objective data as to a narrowing's significance: an FFR reading of <0.8 indicated a significant restriction in blood flow with a recommendation for revascularisation.
The difference in indication for revascularisation of each major coronary artery was also judged according to angiogram alone compared with angiogram plus FFR dtaa."|Up to hospital discharge. Most were day case procedures but no specific data relating to discharge was collected.|||participants|||Number
812432|NCT01070771|Primary|Estimation of Number of Cases Where FFR Data Results in a Change in the Management Strategy (Number of Vessel Requiring Treatment and/or PCI vs Medical vs CABG)|This outcome measure was assessing agreement in the management plan (MP) derived from angiographic assessment alone compared to a MP derived from angiographic assessment plus the use of FFR data acquired at the time of angiography. The study assessed the proportion of cases in which the angiogram directed MP changed after FFR data were disclosed.|Up until hospital discharge. Most cases were day cases but no specific data relating to length of stay collected.|||participants|||Number
812433|NCT01070784|Secondary|Evening FEV1 Measured by the Subjects at Home|The change from run-in period and daily during 52-week randomization treatment|Daily during run-in period and daily 52-week randomization treatment|||Liter(L)||Standard Deviation|Mean
812434|NCT01070784|Secondary|Morning FEV1 Measured by the Subjects at Home|The change from run-in period and daily during 52-week randomization treatment|Daily during run-in period and daily 52-week randomization treatment|||Liter(L)||Standard Deviation|Mean
812435|NCT01070784|Secondary|Evening Peak Expiratory Flow (PEF) Measured at Home|The change from Run-in period average to 52-week randomization Treatment period average for each treatment group|Daily during run-in period and daily 52-week randomization treatment|||Liter/minute(L/min)||Standard Deviation|Mean
812436|NCT01070784|Secondary|Morning Peak Expiratory Flow (PEF) Measured at Home|The change from Run-in period average to 52-week randomization Treatment period average for each treatment group|Daily during run-in period and daily 52-week randomization treatment|||Liter/minute(L/min)||Standard Deviation|Mean
812437|NCT01070784|Secondary|Health Related Quality of Life (HRQL) Based on the St. George’s Respiratory Questionnaire (SGRQ)|The change from run-in period and daily during 52-week randomization treatment average for each treatment group. The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life).|Daily during run-in period and daily 52-week randomization treatment|||units on a scale||Standard Deviation|Mean
812438|NCT01070784|Secondary|Rescue Medication Use|The change from run-in period and daily during 52-week randomization treatment|Daily during 52-week randomization treatment|||innhalation/day||Standard Deviation|Mean
812439|NCT01070784|Secondary|Number of COPD Exacerbations Over the Study Treatment Period|A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as worsening in COPD symptoms requiring treatment with either a course of systemic steroid or hospitalisation. Number of COPD exacerbation during 52-week randomization treatment|Daily during 52-week randomization treatment|||event|||Number
812440|NCT01070784|Secondary|Time to First COPD Exacerbation|A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as worsening in COPD symptoms requiring treatment with either a course of systemic steroid or hospitalisation. The percentage of participants who had experienced COPD exacerbation at the end of the study for each treatment group.|Daily during 52-week randomization treatment|||Percentage of participants|||Number
812441|NCT01070784|Secondary|Forced Vital Capacity (FVC) Measured With the Spirometer at the Clinic|The ratio of the average value of available data for Weeks 0, 4, 8, 17, 26, 34, 43 and 52 to the baseline for each treatment group. Ratio is being reported as a percentage in this Measure.|Before randomization, 0, 4, 8, 17, 26, 34, 43 and 52 weeks after randomization|||percentage of Baseline||Full Range|Geometric Mean
812442|NCT01070784|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Measured With the Spirometer at the Clinic|The ratio of the average value of available data for Weeks 0, 4, 8, 17, 26, 34, 43 and 52 to the baseline for each treatment group. Ratio is being reported as a percentage in this Measure.|Before randomization, 0, 4, 8, 17, 26, 34, 43 and 52 weeks after randomization|||percentage of Baseline||Full Range|Geometric Mean
812481|NCT01071915|Secondary|Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables|The figures present the number of participants who had markedly abnormal levels of safety laboratory variables. Only the laboratory variables that had at least one percentage of participants in either group with abnormal value are presented, more variables were included in the study.|To Day 196|Safety analysis population||participants|||Number
812482|NCT01071915|Secondary|Cumulative Probability of no PSA Failure From Day 28 to Day 196|PSA failure was defined as two consecutive increases of 50%, and at least 5 ng/mL, compared to nadir.|To Day 196|152 participants for this outcome measure is the analysis population from day 28 to day 196||percent probability||95% Confidence Interval|Mean
812483|NCT01071915|Secondary|Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL)From Day 56 to Day 196||Day 56 to Day 196|152 participants for this outcome measure is the analysis population from day 56 to day 196||percent probability||95% Confidence Interval|Mean
812484|NCT01071915|Secondary|Percentage Change in Prostate-specific Antigen (PSA) From Baseline to Day 28||To Day 28|152 participants for this outcome measure is the analysis population from day 0 to day 28||percent||Inter-Quartile Range|Median
812485|NCT01071915|Secondary|Proportion of Patients With Testosterone Level ≤0.5 ng/mL at Day 3||At day 3|Observed cases||percent||95% Confidence Interval|Number
812486|NCT01071915|Primary|Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) From Day 28 to Day 196||Day 28 to Day 196|152 participants for this outcome measure is the analysis population from day 28 to day 196||percent probability||95% Confidence Interval|Mean
812487|NCT01071993|Primary|Primary Endpoint. Development of CIN (Contrast-induced Nephropathy) Defined as a Postprocedure Increase in Serum Creatinine of > 0.5 mg/dL or >25% Increase From Baseline at 24 & at 48 Hours.|Development of CIN (Contrast-induced Nephropathy) Defined as a Postprocedure Increase in Serum Creatinine of > 0.5 mg/dL or >25% Increase From Baseline at 24 & at 48 Hours|48 hours||||||
812488|NCT01072006|Secondary|Neuropsychological Testing (Wechsler Test of Adult Reading)|This test provides an estimate of pre-morbid IQ, which is important to report so that the patient sample can be compared to other similar studies for comparable IQ level and so that pre-morbid IQ can be considered as a potential variable. There are 50 items that are each given a score of 1, so the range of scores is 0-50. The raw score is then converted into an estimated IQ score based on age and education. The scores reported below reflect this estimated IQ score, where normal IQ scores range from 75 as low average to 125 as high average.|These are chronic patients and controls who will only be tested at one time point, which corresponds to their entry into the study (after signing consent forms). Data collected at this single time point will be reported.|||units on a scale||Standard Deviation|Mean
812489|NCT01072006|Secondary|Psychodiagnostic Testing: Post-traumatic Stress Disorder Check List (PCL) Measures the Level of Post-traumatic Stress Disorder (PTSD) Symptoms|The PCL is a 17-item questionnaire that measures PTSD symptoms on a scale that ranges from 17-85 points. The total severity score is reported below. A higher score means a higher level of PTSD symptoms.|These are chronic patients and controls who will only be tested at one time point, which corresponds to their entry into the study (after signing consent forms). Data collected at this single time point will be reported.|||units on a scale||Standard Deviation|Mean
812490|NCT01072006|Primary|Functional Magnetic Resonance Imaging (fMRI) Correlation|Functional magnetic resonance imaging (fMRI) is used to measure neural activity in participants during attentional task, specifically measured as a bold signal change from rest to attention task. We then calculate the correlation between the bold signal (fMRI) and the PTSD CheckList questionnaire score. (The bold signal from fMRI indirectly reflects the brain's use of glucose, the brain's main energy source.) Correlations are reflected in an R-value, and R-values can range from 0-1, where 0 means there is no correlation (or relationship) between the two measures (here, the two measures are the fMRI brain signal and the PTSD score) and 1 means there is a perfect correlation between the two measures. A high correlation in this study would suggest that the more severe a patient's PTSD symptoms are, the harder their brain is having to work to accomplish the attention task. Separate correlations were analyzed for each group, and the overall R-value for each group is reported below.|These are chronic patients and controls who will only be tested at one time point, which corresponds to their entry into the study (after signing consent forms). Data collected at this single time point will be reported.|||r-value|||Number
812491|NCT01072032|Secondary|EEG Spectral Coherence Estimates|EEG coherence reflects the degree to which brain regions communicate. It is derived from calculating the degree of association between regions in specified frequency bandwidths; it is like a correlation, except that the values range from 0-1 instead of -1 to 1, so technically there are no units as it is a coefficient. Higher coherence values indicate stronger associations between regions.|3 weeks|||Coherence ratio||Standard Deviation|Mean
812492|NCT01072032|Secondary|Functional Walking Measures|Preferred, self-selected walking velocity measured in centimeters/second (i.e., cm/s).|3 weeks|||cm/s||Standard Deviation|Mean
812493|NCT01072032|Primary|Motor Control|Normalized jerk is a measure of movement smoothness, derived from jerk [(meters)/(second cubed)] divided by the peak velocity (meters/second), leaving values in units of 1/second squared (ie., 1/s^2)|3 weeks|||1/s^2||Standard Deviation|Mean
812494|NCT01072136|Secondary|Determine the Clinical Cure, Partial Response and Failure Proportions for Mucopurulent Cervicitis at 2-3 Weeks for Each Study Arm.|"Clinical Failure:
Persistent cervical mucopus and/or easily induced cervical bleeding, and the presence of > 30 WBCs per oil immersion field on cervical gram stain OR
Signs of pelvic inflammatory disease, including cervical motion tenderness, uterine tenderness or adnexal tenderness.
Partial Response:
Persistent cervical mucopus and/or easily induced cervical bleeding and <30 WBCs per oil immersion field on cervical gram stain OR
The presence of ≥ 30 WBCs per oil immersion field on cervical gram stain in the absence of both cervical mucopus and easily induced cervical bleeding.
Clinical Cure:
• Absence of cervical mucopus and absence of easily induced cervical bleeding and < 30 WBC's per oil immersion field on cervical gram stain."|At 2-3 weeks follow-up.|Received study product, met all eligibility criteria, and had complete outcome data at 2-3 weeks.||percentage of participants|||Number
812521|NCT01072175|Secondary|Overall Survival (OS) in Part B BRAFi Naïve Melanoma Participants|OS is defined as the interval of time between the date of randomization until the date of death due to any cause. For the participants who did not die, overall survival was censored at the date of last contact.|From the date of first dose until date of death due to any cause (up to approximately 22 months)|All Treated Population.||Months||95% Confidence Interval|Median
812495|NCT01072136|Secondary|Determine the Clinical Cure, Partial Response and Failure Proportions for Mucopurulent Cervicitis at 2 Months for Each Study Arm.|"Clinical Failure:
Persistent cervical mucopus and/or easily induced cervical bleeding, and the presence of > 30 WBCs per oil immersion field on cervical gram stain OR
Signs of pelvic inflammatory disease, including cervical motion tenderness, uterine tenderness or adnexal tenderness.
Partial Response:
Persistent cervical mucopus and/or easily induced cervical bleeding and <30 WBCs per oil immersion field on cervical gram stain OR
The presence of ≥ 30 WBCs per oil immersion field on cervical gram stain in the absence of both cervical mucopus and easily induced cervical bleeding.
Clinical Cure:
• Absence of cervical mucopus and absence of easily induced cervical bleeding and < 30 WBC’s per oil immersion field on cervical gram stain."|At 2 month ( Day 50-70) follow-up.|Per protocol. Received study product, met all eligibility criteria, had complete primary outcome data, and absence of any major protocol violations.||percentage of participants|||Number
812496|NCT01072136|Secondary|Evaluate Microbiological Cure of Mycoplasma Genitalium in Women Treated With Cefixime and Azithromycin Versus Placebo.|The proportion of participants with mycoplasma genitalium at baseline who clear mycoplasma genitalium in either the vagina or cervix at their last follow-up visit.|At 2-3 weeks and 2 month (Day 50-70) follow-up.|Participants who were positive for mycoplasma genitalium in either the cervix or vagina at baseline and who met eligibility criteria and who returned for at least one of the follow-up visits.||participants|||Number
812497|NCT01072136|Secondary|Explore the Role of Mycoplasma Genitalium in Persistent Mucopurulent Cervicitis (MPC).|"Proportion of participants with clinical failure, partial response, or clinical cure for mucopurulent cervicitis at 2 months according to mycoplasma genitalium status(positive cervical or vaginal swabs versus both negative) at 2 months.
Clinical Failure:
Persistent cervical mucopus and/or easily induced cervical bleeding, and the presence of > 30 WBCs per oil immersion field on cervical gram stain OR
Signs of pelvic inflammatory disease, including cervical motion tenderness, uterine tenderness or adnexal tenderness.
Partial Response:
Persistent cervical mucopus and/or easily induced cervical bleeding and <30 WBCs per oil immersion field on cervical gram stain OR
The presence of ≥ 30 WBCs per oil immersion field on cervical gram stain in the absence of both cervical mucopus and easily induced cervical bleeding.
Clinical Cure:
• Absence of cervical mucopus and absence of easily induced cervical bleeding and < 30 WBC’s per oil immersion field on cervical gram stain."|At 2 month (Day 50-70) follow-up.|Participants who met eligibility criteria and were not positive for chlamydia, gonorrhea, cervical trichomonas at 2-month follow-up.||percentage of participants|||Number
812498|NCT01072136|Secondary|Explore the Role of Bacterial Vaginosis (BV) in Persistent Mucopurulent Cervicitis (MPC).|"Proportion of participants with clinical failure, partial response, or clinical cure for mucopurulent cervicitis at 2 month follow-up according to asymptomatic bacterial vaginosis status at 2 month follow-up.
Clinical Failure:
Persistent cervical mucopus and/or easily induced cervical bleeding, and the presence of > 30 WBCs per oil immersion field on cervical gram stain OR
Signs of pelvic inflammatory disease, including cervical motion tenderness, uterine tenderness or adnexal tenderness.
Partial Response:
Persistent cervical mucopus and/or easily induced cervical bleeding and <30 WBCs per oil immersion field on cervical gram stain OR
The presence of ≥ 30 WBCs per oil immersion field on cervical gram stain in the absence of both cervical mucopus and easily induced cervical bleeding.
Clinical Cure:
• Absence of cervical mucopus and absence of easily induced cervical bleeding and < 30 WBC’s per oil immersion field on cervical gram stain."|At 2 month (Day 50-70) follow-up.|Participants who met eligibility criteria and were not positive for chlamydia, gonorrhea, cervical trichomonas or cervical mycoplasma genitalium at 2 month follow-up.||percentage of participants|||Number
812499|NCT01072136|Secondary|Examine Adverse Events in Patients Empirically Treated With Cefixime and Azithromycin for Mucopurulent Cervicitis (MPC) in Comparison to no Treatment.|The proportion of participants experiencing one or more adverse events after randomization.|At 2-3 week and 2 month (Day 50-70) follow-up.|Participants who were randomized and received study product.||percentage of participants|||Number
812500|NCT01072136|Secondary|Determine Pelvic Inflammatory Disease (PID) in Patients Empirically Treated With Cefixime and Azithromycin for Mucopurulent Cervicitis (MPC) in Comparison to no Treatment.|The number of participants experiencing PID after randomization.|At 2-3 week and 2 month (Day 50-70) follow-up.|Participants who were randomized and received study product.||participants|||Number
812501|NCT01072136|Primary|Evaluate Clinical Cure in Participants Not Treated Versus Participants Empirically Treated With Cefixime and Azithromycin for Mucopurulent Cervicitis (MPC).|The proportion of participants who have cleared MPC by the second follow-up visit. Clinical cure is defined as: absence of cervical mucopus and absence of easily induced cervical bleeding and < 30 white blood cells per oil immersion field on cervical gram stain.|Visit 2 - 2 months (Day 50-70).|Per protocol. Received study product, met eligibility criteria, had complete primary outcome data, and absence of any major protocol violations.||percentage of participants|||Number
812502|NCT01072149|Secondary|Change From Period Baseline in 25-hour Serial FEV1 at the End of Each 28 Day-treatment Period|Change from period Baseline in 0-25 hour serial FEV1 (0 to 25 hours) over Period Days 28-29 was measured. Mean Baseline FEV1 for a given participant is defined as the mean of all available period Baseline FEV1 values. Data are presented as the mean of change from Baseline for all three treatment periods. Analysis was performed using a mixed effects repeated measures model with covariates of period treatment group, period Baseline, mean Baseline, period and time after dosing (nominal), in addition to time after dosing by period Baseline, time after dosing by mean Baseline, and time after dosing by period treatment interaction terms as fixed effects and participant as a random effect.|Baseline; pre-dose; 5 minutes, 15 minutes, 30 minutes, 60 minutes, and 2, 4, 6, 8, 12, 16, 20, 22, 23, 24, and 25 hours post-dose on Day 28 and Day 29 of each 28-day treatment period (up to 19 weeks)|ITT Population. Only those participants available at the indicated time points were assessed.||Liters||Standard Error|Least Squares Mean
812530|NCT01072175|Secondary|The AUC [0-tau] of Dabrafenib (DAB) and Its Metabolite in Combination With Trametinib (T) in Part B|Area under the concentration-time curve from time zero (predose) until the last time of quantifiable concentration (AUC [0-tau]) was assessed. Blood samples for PK analysis of dabrafenib and its the metabolites hydroxy-dabrafenib (GSK2285403), carboxy-dabrafenib (GSK2298683) and desmethyl-dabrafenib (GSK2167542) were obtained at Day 15 pre-dose and Day 21 pre-dose and at 1, 2, 4, 6, and 8 hours post-dose administration.|Day 15 and Day 21|PK Population. Only those participants who were available at the indicated time point were analyzed.||ng*hr/mL||95% Confidence Interval|Geometric Mean
812503|NCT01072149|Secondary|Change From Period Baseline in Clinic Visit Trough FEV1 at the End of Each 28-day Treatment Period|Trough FEV1 is defined as the mean of the 23- and 24-hour post-dose assessments. For each treatment period, period Baseline is defined as the mean of the -30 and -5 minute measurements taken on Period Day 1. Mean Baseline FEV1 for a given participant is defined as the mean of all available period Baseline FEV1 values. Data are presented as the mean of change from Baseline for all three treatment periods. Change from Baseline was calculated as the value at Period Day 29 minus the value at Baseline. Analysis was performed using a mixed effects model with covariates of period treatment group, period Baseline, mean Baseline, and period as fixed effects and participant as a random effect.|From Baseline to the end of each 28-day treatment period (up to 19 weeks)|ITT Population. Only those participants available at the indicated time points were assessed.||Liters||Standard Error|Least Squares Mean
812504|NCT01072149|Primary|Time-adjusted Area Under the Curve (AUC) (i.e., Weighted Mean) for 24-hour Serial Forced Expiratory Volume in One Second (FEV1) at the End of Each 28-day Treatment Period|FEV1 is defined as the amount of air that can be forcibly exhaled from the lungs in the first second of a forced exhalation. The weighted mean was calculated from pre-dose FEV1 (calculated as the mean of the -30 and -5 minute measurements) and post-dose FEV1 after 5, 15, 30, and 60 minutes and after 2, 4, 6, 8, 12, 16, 20, 22, 23, and 24 hours. Data are provided as the Least Squares Mean of the weighted mean for all three treatment periods. Analysis was performed using a mixed effects model with covariates of period treatment group, period Baseline, mean Baseline (defined as the mean of all available period Baseline FEV1 values), and period as fixed effects and participant as a random effect.|Pre-dose and the end of each 28-day treatment period (up to 19 weeks)|Intent-to-Treat (ITT) Population: all participants who were randomized to and received at least one dose of trial medication in any treatment period. Only those participants available at the indicated time points were assessed.||Liters||Standard Error|Least Squares Mean
812505|NCT01072175|Secondary|Overall Survival in Part D|OS is defined as the interval of time between the date of randomization until the date of death due to any cause. For the participants who did not die, overall survival was censored at the date of last contact. Validation of OS is currenlty ongoing; thus, data are not available at this time.|From the date of first dose until date of death due to any cause (up to approximately 14 months)||06/2017||||
812506|NCT01072175|Secondary|Progression-free Survival (PFS) as Assessed by the Investigator in Part D|PFS is defined as the interval between the first dose of study medication and the earliest date of PD or death due to any cause. PD was based on radiographic or photographic evidence, and assessments were made by the investigator according to RECIST, version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm.|From the date of randomization to the earliest date of disease progression (PD) or death due to any cause (up to approximately 13 months)|ITT Population||Months||95% Confidence Interval|Median
812507|NCT01072175|Secondary|Duration of Response as Assessed by the Investigator in Part D|Duration of response for participants with either a CR (the disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis.) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]) is defined as the time from the first documented evidence of a PR or CR until the first documented sign of disease progression (PD) or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm.|First documented evidence of PR or CR until the earlier of date of disease progression or date of death due to any cause (up to approximately 13 months)|ITT Population. Only those participants who had CR or PR were considered.||Months||95% Confidence Interval|Median
812508|NCT01072175|Secondary|Number of Participants With the Best Overall Response as Assessed by the Investigator in Participants in Part D|Best overall response is defined as complete response (CR: the disappearance of all target lesions. Any pathological lymph nodes must be <10 milimeter [mm] in the short axis.) or partial reponse (PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]). To be assigned a status of PR or CR, a confirmatory disease assessment should be performed no less than 28 days after the criteria for response are first met. Response was evaluated by an investigator as per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.|From the date of first dose of study medication to the first documented evidence of a confirmed complete response or partial response (up to approximately 280 days )|ITT Population||Participants|||Number
812509|NCT01072175|Secondary|Area Under the Concentration-time Curve Assessment of Trametinib in Part D|AUC(0-tau) after single and repeat dose of teametinib alone and in combination with dabrafenib was observed at Day 1 and Day 21. Blood samples for PK analysis of dabrafenib were obtained at pre-dose Day 1 and Day 21 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours (Day 1 only) post-dose administration. From the plasma concentration-time curve, the PK parameter tmax was determined by standard non-compartmental analysis using WinNonlin.Participants receiving DAB 75 mg to DAB 75 mg + Trametinib 2 mg and those receiving DAB 150 mg to DAB 150 mg + Trametinib 2 mg did not receive Trametinib until Day 29; therefore, AUC(0-tau) was not analyzed in these participants at Days 1 and 21.|Day 1: pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post dose. Day 21: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours post-dose|PK Population. Only participants who were available at the indicated timepoints were analyzed.||ng*h/mL||95% Confidence Interval|Geometric Mean
812531|NCT01072175|Secondary|Steady State Concentration of Trametinib With Concomitant Administration of Dabrafenib in Part A|The steady state plasma concentration (Css) of trametinib with concomitant dabrafenib administration was assessed at Day 15 and Day 16. At steady state the amount of drug administered (in a given time period) is equal to the amount of drug eliminated.|Day 15 and Day 16|PK Population||ng/mL||Full Range|Median
812874|NCT01074502|Primary|Percentage of Patients With a Success Rate (Based on the Researcher's Global Assessment (RGA) Sum of Clear (0) or Almost Clear (1))|RGA measures the severity of acne. The scale goes from 0-4. 0 will be better and 4 will be worse. Scores can only be whole numbers (0,1,2,3,4)ordinal.|Baseline to 16 weeks|small number of subjects to analyze|||||
812510|NCT01072175|Secondary|The Tmax Assessment of Trametinib in Part D|The tmax of trametinib after single and repeat dose in combination with dabrafenib (DAB) was observed at Day 1 and Day 21. Blood samples for PK analysis of dabrafenib were obtained at pre-dose Day 1 and Day 21 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours (Day 1 only) post-dose administration. From the plasma concentration-time curve, the PK parameter tmax was determined by standard non-compartmental analysis using WinNonlin.Participants receiving DAB 75 mg to DAB 75 mg + Trametinib 2 mg and those receiving DAB 150 mg to DAB 150 mg + Trametinib 2 mg did not receive Trametinib until Day 29; therefore, tmax was not analyzed in these participants at Days 1 and 21.|Day 1: pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post dose. Day 21: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours post-dose|PK Population. Only participants who were available at the indicated timepoints were analyzed.||Hours||Full Range|Median
812511|NCT01072175|Secondary|The Cmax Assessment of Trametinib in Part D|Cmax of trametinib after single and repeat dose in combination with DAB was observed at Day 1 and Day 21. Blood samples for PK analysis of dabrafenib were obtained at pre-dose Day 1 and Day 21 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours (Day 1 only) post-dose administration. From the plasma concentration-time curve, the PK parameter tmax was determined by standard non-compartmental analysis using WinNonlin.Participants receiving DAB 75 mg to DAB 75 mg + Trametinib 2 mg and those receiving DAB 150 mg to DAB 150 mg + Trametinib 2 mg did not receive Trametinib until Day 29; therefore, Cmax was not analyzed in these participants at Days 1 and 21.|Day 1: pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post dose. Day 21: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours post-dose|PK Population. Only participants who were available at the indicated timepoints were analyzed.||ng/mL||95% Confidence Interval|Geometric Mean
812512|NCT01072175|Secondary|Area Under the Concentration-time Curve (AUC) of Dabrafenib Metabolites in Part D|Area under the concentration-time curve (AUC) from pre-dose to dosing interval (AUC[0-tau]), from pre-dose to the last time of quantifable concentration (AUC[0-tau]), and from pre-dose extrapolated to infinity (AUC[0-inf]) of DAB metabolites hydroxy-dabrafenib (GSK2285403), carboxy-dabrafenib (GSK2298683) and desmethyl-dabrafenib (GSK2167542) after single and repeat doses of DAB alone and in combination with trametinib was measured at Day 1 and Day 21.|Day 1: pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post dose. Day 21: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours post-dose|PK Population. Only participants who were available at the indicated timepoints were analyzed.||ng*hr/mL||95% Confidence Interval|Geometric Mean
812513|NCT01072175|Secondary|The Tmax of Dabrafenib Metabolites in Part D|The time to Cmax (tmax) of DAB metabolites hydroxy-dabrafenib (GSK2285403), carboxy-dabrafenib (GSK2298683) and desmethyl-dabrafenib (GSK2167542) after single and repeat doses of DAB alone and in combination with trametinib was measuered at Day 1 and Day 21.|Day 1: pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post dose. Day 21: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours post-dose|PK Population. Only participants who were available at the indicated timepoints were analyzed.||Hours||Full Range|Median
812514|NCT01072175|Secondary|Cmax of Dabrafenib Metabolites in Part D|The maximum concentration (Cmax) of dabrafenib metabolites hydroxy-dabrafenib (GSK2285403), carboxy-dabrafenib (GSK2298683) and desmethyl-dabrafenib (GSK2167542) after single and repeat doses of DAB alone and in combination with trametinib was measured at Day 1 and Day 21.|Day 1: pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post dose. Day 21: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours post-dose|PK Population. Only participants who were available at the indicated timepoints were analyzed.||ng/mL||95% Confidence Interval|Geometric Mean
812515|NCT01072175|Secondary|Oral Volume of Distribution (V/F) of Dabrafenib and Trametinib|Oral volume of distribution (V/F) of dabrafenib and trametinib were assessed using a population approach. Oral volume of distribution (V/F) is defined as the apparent volume of distribution in the central compartment.|Day 15, Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48|PK Population||Liters (L)||95% Confidence Interval|Mean
812516|NCT01072175|Secondary|Oral Clearance (CL/F) of Dabrafenib and Trametinib|Oral clearance (CL/F) of dabrafenib and trametinib were assessed using a population approach. Oral clearance (CL/F) is defined as the apparent volume of plasma in the vascular compartment cleared of drug per unit time by the processes of metabolism and excretion. For dabrafenib, population CL/F is defined as inducible and non-inducible CL/F. As dabrafenib induces its own metabolism, total oral clearance at steady state includes a non-induced (Day 1) component and an induced component, as estimated by a population PK model.|Day 15, Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48|PK Population||Liters per hour (L/hr)||95% Confidence Interval|Mean
812517|NCT01072175|Secondary|Plasma Concentrations of Trametinib in Part C|Plasma concentrations of trametinib was assessed following daily dose of dabrafenib and trametinib.|Day 15, Week 8, Week 16, Week 24, Week 32, Week 40, Week 48, and Week 56|PK Population. Only those participants who were available at the indicated time points were analyzed.||ng/mL||Full Range|Median
812518|NCT01072175|Secondary|Plasma Concentrations of Dabrafenib and Its Metabolites in Part C|Plasma concentrations of dabrafenib and its metabolites hydroxy-dabrafenib (GSK2285403), carboxy-dabrafenib (GSK2298683) and desmethyl-dabrafenib (GSK2167542) were assesed following daily dose of dabrafenib and trametinib.|Day 15, Week 8, Week 16, Week 24, Week 32, Week 40, Week 48, and Week 56|PK Population. Only those participants who were available at the indicated time points were analyzed.||ng/mL||Full Range|Median
812519|NCT01072175|Secondary|Overall Survival (OS) in Part C|OS is defined as the interval of time between the date of randomization until the date of death due to any cause. For the participants who did not die, overall survival was censored at the date of last contact. When calculating overall survival, deaths following crossover were included.|From the date of randomization until date of death due to any cause (up to approximately 17 months)|ITT Population||Months||95% Confidence Interval|Median
812520|NCT01072175|Secondary|Pre- and Post-dose H-scores for Individual Participants in Part B|p-ERK and p-AKT, biomarkers in tumor biopsies, were assessed for participants with BRAF mutant colorectal cancer. The H-score, which is a composite score that comprises intensity and percentage of staining, is a method of assessing the amount of protein or phospho-protein present in a biopsy sample. The score is obtained by the formula: (3 * percentage of strongly staining nuclei) + (2 * percentage of moderately staining nuclei) + (percentage of weakly staining nuclei). The H-score ranges from 0 to 300, with a score of 0 representing the absence of any of the target protein and an H-score of 300 representing maximum staining and intensity of the target protein.|Screening and at disease progression (up to approximately 8 months)|Biomarker Population: participants with H-score data for pre- and post-biopsy pairs||scores on a scale|||Number
812522|NCT01072175|Secondary|Progression-free Survival (PFS) as Assessed by the Investigator in Participants With BRAFi-naïve Mutant Metastatic Melanoma in Part B|PFS is defined as the interval between the first dose of study medication and the earliest date of PD or death due to any cause. PD was based on radiographic or photographic evidence, and assessments were made by the investigator according to RECIST, version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm. BRAFi-naïve were the participants with BRAF-mutation positive melanoma who had not received prior therapy with a BRAF-inhibitor..|From the date of first dose to the earliest date of disease progression (PD) or death due to any cause (up to approximately 22 months)|All Treated Population.||Months||95% Confidence Interval|Median
812523|NCT01072175|Secondary|Duration of Response as Assessed by the Investigator in Participants With BRAFi-naïve Mutant Metastatic Melanoma in Part B|Duration of response for participants with either a CR (the disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis.) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]) is defined as the time from the first documented evidence of a PR or CR until the first documented sign of disease progression (PD) or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm. BRAFi-naïve participants were those with BRAF-mutation-positive melanoma who had not received prior therapy with a BRAF inhibitor.|First documented evidence of PR or CR until the earlier of date of disease progression or date of death due to any cause (up to approximately 22 months)|All Treated Population. Only those participants who had a CR or PR were analyzed.||Months||95% Confidence Interval|Median
812524|NCT01072175|Secondary|Number of Participants With BRAFi-naïve Mutant Metastatic Melanoma With the Best Overall Response as Assessed by Investigator in Part B|Best overall response is defined as complete response (CR: the disappearance of all target lesions. Any pathological lymph nodes must be <10 milimeter [mm] in the short axis.) or partial reponse (PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]). Participants with unknown or missing response were considered as non-responders. To be assigned a status of PR or CR, a confirmatory disease assessment should have been performed no less than 28 days after the criteria for response were first met. Response was evaluated by an investigator as per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. BRAFi-naïve participants were those with BRAF-mutation-positive melanoma who had not received prior therapy with a BRAF inhibitor.|From the first dose of study medication to the first documented evidence of a confirmed complete response or partial response (up to 103 weeks)|All Treated Population||Participants|||Number
812525|NCT01072175|Secondary|The Tmax Assessment of Trametinib in Combination With Dabrafenib in Part B (Analyte=GSK1120212)|The tmax is defined as the time of occurrence of Cmax. The PK parameter for tmax was assessed for plasma trametinib following repeat dosing of trametinib in combination with dabrafenib. Blood samples for PK analysis of the metabolites of dabrafenib were obtained at Day 15 pre-dose or Day 21 pre-dose and at 1, 2, 4, 6, and 8 hours post-dose administration.|Day 15 and Day 21|PK Population. Only those participants who were available at the indicated time point were analyzed.||Hours||Full Range|Median
812526|NCT01072175|Secondary|The Ctau and Cmax Assessments of Trametinib in Combination With Dabrafenib in Part B (Analyte=GSK1120212)|Pre-dose (trough) concentration at the end of the dosing interval (Ctau) and maximum plasma concentration (Cmax) were assessed for plasma trametinib following repeat dosing of trametinib in combination with dabrafenib. Blood samples for PK analysis of the metabolites of dabrafenib were obtained at Day 15 pre-dose or Day 21 pre-dose and at 1, 2, 4, 6, and 8 hours post-dose administration.|Day 15 and Day 21|PK Population. Only those participants who were available at the indicated time point were analyzed.||ng/mL||95% Confidence Interval|Geometric Mean
812527|NCT01072175|Secondary|The AUC (0-tau) Assessment of Trametinib in Combination With Dabrafenib in Part B (Analyte=GSK1120212)|AUC (0-tau) is defined as area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration. AUC (0-tau) was assessed for plasma trametinib following repeat dosing of trametinib in combination with dabrafenib. Blood samples for PK analysis of the metabolites of dabrafenib were obtained at Day 15 pre-dose and Day 21 pre-dose and at 1, 2, 4, 6, and 8 hours post-dose administration.|Day 15 and Day 21|PK Population. Only those participants who were available at the indicated time points were analyzed.||ng*hr/mL||95% Confidence Interval|Geometric Mean
812528|NCT01072175|Secondary|The Tmax of Dabrafenib and Its Metabolite in Combination With Trametinib in Part B|The tmax is defined as the time of occurenceof Cmax. Tha tmax was assessed for plasma dabrafenib (DAB) following repeat dosing of dabrafenib 75 and 150 mg BID administered in combination with trametinib. Blood samples for PK analysis of the metabolites hydroxy-dabrafenib (GSK2285403), carboxy-dabrafenib (GSK2298683) and desmethyl-dabrafenib (GSK2167542) of dabrafenib were obtained at Day 15 pre-dose and Day 21 pre-dose and at 1, 2, 4, 6, and 8 hours post-dose administration.|Day 15 and Day 21|PK Population. Only those participants who were available at the indicated time points were analyzed.||Hours||Full Range|Median
812529|NCT01072175|Secondary|Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ctau) and Maximum Plasma Concentration (Cmax) of Dabrafenib and Its Metabolite in Combination With Trametinib in Part B|Pre-dose (trough) concentration at the end of the dosing interval (Ctau) and maximum plasma concentration (Cmax) were assessed for plasma dabrafenib (DAB) following repeat dosing of DAB administered in combination with trametinib (T). The trough concentration is defined as the plasma level of a pharmaceutical product measured just before the next dose. Blood samples for PK analysis of the metabolites hydroxy-dabrafenib (GSK2285403), carboxy-dabrafenib (GSK2298683) and desmethyl-dabrafenib (GSK2167542) of dabrafenib were obtained at Day 15 pre-dose and Day 21 pre-dose and at 1, 2, 4, 6, and 8 hours post-dose administration.|Day 15 and Day 21|PK Population. Only those participants who were available at the indicated time points were analyzed.||ng/mL||95% Confidence Interval|Geometric Mean
824785|NCT01178268|Secondary|Follow-up In-stent Minimum Lumen Diameter (MLD)||≥13 months|The number of participants with angiographic follow up available was analysed.||Millimeter|Participants|Standard Deviation|Mean
812532|NCT01072175|Primary|Number of Participants With the Indicated Worst-case Change From Baseline in Heart Rate and Blood Pressure in Part D|Blood pressure were summarized according to National Cancer Institutes (NCI) CTCAE grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to G3 or G4 occurred.lood pressure measurement included systolic blood pressure (BP, milimeter of mercury [mmHg]) and diastolic BP (DBP). Worst case change from Baseline was calculated as the post-Baseline value minus the Baseline value. Heart Rate is the measure of heartbeats per minute (bpm). Changes in heart rate, either decrease to <60 bpm, change to normal or no change, or increase to >100 bpm are presented|From Baseline (Day 1) until Follow-up visit (up to approximately 61 weeks)|ATP Population||Participants|||Number
812533|NCT01072175|Primary|Number of Participants With the Indicated Worst-case Grade Change From Baseline in the Indicated Hematology Parameters in Part D|Hematology parameters were summarized according to NCI CTCAE grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to Grade 3 or Grade 4 occurred. For hematology parameters that were not graded according to NCI CTCAE criteria, changes above (High) and below (Low) the normal range were evaluated. Hematology parameters included lymphocytes, total neutrophils, hemoglobin, white blood cell count, platelet count, monocytes, mean corpuscle hemoglobin concentration, eosinophils, basophils, mean corpuscle hemoglobin, mean corpuscle volume, red blood cell count, hematocrit, erythrocyte sedimentation, reticulocytes. Worst case change from Baseline was calculated as the post-Baseline value minus the Baseline value.|From Baseline (Day 1) until Follow-up visit (up to approximately 61 weeks)|ATP Population. Only those participants available at indicated timepoints were analyzed.||Participants|||Number
812534|NCT01072175|Primary|Number of Participants With the Indicated Worst-case Grade (G) Change From Baseline in the Indicated Clinical Chemistry Parameters in Part D|Clinical chemistry parameters were summarized according to NCI CTCAE grade, version 4.0. G1, Mild; G2, Moderate; G3, Severe; G4, Life-threatening or disabling; G5, Death. Data are presented for only those parameters for which an increase to G3 or G4 occurred. Changes above (High) and below (Low) the normal range were evaluated for parameters not graded. Included:hyponatremia,gamma glutamyltransferase (GGT),aspartate aminotransferase (AST),hyperglycemia,alkaline phosphatase,hypokalemia,alanine aminotransferase (ALT),phosphorus inorganic,creatine kinase,total bilirubin,albumin,hyperkalemia, hypomagnesemia,lipase,hypokalemia,hyponatremia,urea/blood urea nitogen (BUN),bicarbonate,creatine clearance,chloride,C-reactive protein,total protein,uric acid,troponin I,direct bilirubin,creatine kinase MB mass, chloride,total protein,bicarbonate,uric acid,creatine clearance,lactate dehydrogenase. Worst case change from BL was calculated as the post-BL value minus the BL value.|From Baseline (Day 1) until Follow-up visit (up to approximately 61 weeks)|ATP Population. Only those participants available at indicated timepoints were analyzed.||Participants|||Number
812535|NCT01072175|Primary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) in Part D|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event for possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.|From Baseline (Day 1) until Follow-up visit (up to approximately 61 weeks)|ATP Population||Participants|||Number
812536|NCT01072175|Primary|AUC (0-tau) and AUC (0-inf) of Single and Repeat Doses of Dabrafenib Alone and in Combination With Trametinib in Part D (Analyte=GSK2118436)|The PK parameters were determined for area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration AUC (0-tau) and from time zero (pre-dose) extrapolated to infinite time AUC (0-inf). Blood samples for PK analysis of the metabolites of dabrafenib were obtained at Day 1 and Day 21 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours (24 hour only on Day 1) post-dose administration.|Day 1 and Day 21|PK Population. Only participants available at the indicated timepoints were analyzed.||ng*hr/mL||95% Confidence Interval|Geometric Mean
812537|NCT01072175|Primary|The Tmax of a Single and Repeat Dose of Dabrafenib Alone and in Combination With Trametinib in Part D (Analyte=GSK2118436)|tmax is defined as the time of occurenceof Cmax. Blood samples for PK analysis of dabrafenib were obtained at Day 1 and Day 21 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours (24 hour on Day 1 only) post-dose administration. From the plasma concentration-time curve, the PK parameter tmax was determined by standard non-compartmental analysis using WinNonlin.|Day 1 and Day 21|PK Population. Only participants available at the indicated timepoints were analyzed.||Hours||Full Range|Median
812538|NCT01072175|Primary|Maximum Plasma Concentration (Cmax) of a Single and Repeat Dose of Dabrafenib Alone and in Combination With Trametinib in Part D (Analyte=GSK2118436)|The PK parameter Cmax was assessed. Blood samples for PK analysis of dabrafenib were obtained at pre-dose Day 1 and Day 21 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours (24 hour on Day 1 only) post-dose administration. From the plasma concentration-time curve, the PK parameter tmax was determined by standard non-compartmental analysis using WinNonlin. Cmax data are reported as geometric least squares means.|Day 1 and Day 21|PK Population: all participants who received at least one dose of either dabrafenib or trametinib and for whom a PK sample was obtained and analyzed||ng/mL||95% Confidence Interval|Geometric Mean
812539|NCT01072175|Primary|Number of Participants With the Indicated Worst-case Change From Baseline in Heart Rate and Blood Pressure in Part C (Randomized)|Blood pressure were summarized according to National Cancer Institutes (NCI) CTCAE grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to G3 or G4 occurred.lood pressure measurement included systolic blood pressure (BP, milimeter of mercury [mmHg]) and diastolic BP (DBP). Worst case change from Baseline was calculated as the post-Baseline value minus the Baseline value. Heart Rate is the measure of heart beats per minute (bpm). Changes in heart rate, either decrease to <60 bpm, change to normal or no change, or increase to >100 bpm are presented.|From Baseline (Day 1) until Follow-up visit (up to approximlately 75 weeks)|ATP Population||Participants|||Number
813129|NCT01077024|Secondary|Point-prevalence Abstinence (Smoking Outcome) 3 Month Visit|point-prevalence abstinence defined as not smoking in the previous seven days based on self-report and confirmed with a Carbon Monoxide (CO) level ≤ 8 ppm|3- month follow-up visits|||percentage of participants|||Number
812540|NCT01072175|Primary|Number of Participants With the Indicated Worst-case Grade Change From Baseline in the Indicated Hematology Parameters in Part C (Randomized)|Hematology parameters were summarized according to National Cancer Institutes (NCI) CTCAE grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3, Severe; Grade 4, Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to any grade, Grade 3 or Grade 4 occurred. For hematology parameters that were not graded according to NCI CTCAE criteria, changes above (High) and below (Low) the normal range were evaluated. Hematology parameters included: hemoglobin, lymphocytes, Total absolute neutrophil count (ANC), platelet count, white blood cells (WBC) count. Worst case change from Baseline was calculated as the post-Baseline value minus the Baseline value.|From Baseline (Day 1) until Follow-up visit (up to approximately 75 weeks)|ATP Population. Only those participants who were available at the indicated time points were analyzed.||Participants|||Number
812541|NCT01072175|Primary|Number of Participants With the Indicated Worst-case Grade (G) Change From Baseline in the Indicated Clinical Chemistry Parameters in Part C (Randomized)|Clinical chemistry parameters were summarized according to National Cancer Institutes (NCI) CTCAE grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3, Severe; Grade 4, Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to any grade, Grade 3 or Grade 4 occurred. For clinical chemistry parameters that were not graded according to NCI CTCAE criteria, changes above (High) and below (Low) the normal range were evaluated. Clinical chemistry parameters included: albumin, alkaline phosphate (ALKP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), total Bilirubin, calcium, creatine kinase, creatinine, gamma glutamyltransferase (GGT), glucose, potassium, magnesium, sodium, inorganic phosphorus. Worst case change from Baseline was calculated as the post-Baseline value minus the Baseline value.|From Baseline (Day 1) until Follow-up visit (up to approximately 75 weeks)|ATP Population. Only those participants who were available at the indicated time points were analyzed.||Participants|||Number
812542|NCT01072175|Primary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) in Part C (Randomized)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.|From Baseline (Day 1) until Follow-up visit (up to approximatley 75 weeks)|ATP Population||Participants|||Number
812543|NCT01072175|Primary|Progression-free Survival (PFS) as Assessed by the Investigator in Part C (Crossover)|PFS is defined as the interval between the first dose of study medication and the earliest date of PD or death due to any cause. PD was based on radiographic or photographic evidence, and assessments were made by the investigator according to RECIST, version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm. Participants received anti-cancer therapy prior to the date of documented events, and censored at the last adequate assessment, prior to the initiation of therapy. If the participant did not have a documented date of events, PFS and survival were censored at the date of the last adequate assessment.|From the first dose of study medication to the earliest date of disease progression (PD) or death due to any cause (up to approximately 9 months)|Crossover Population||Months||95% Confidence Interval|Median
812544|NCT01072175|Primary|Progression-free Survival (PFS) as Assessed by the Blinded Independent Central Review (BICR) in Part C (Randomized)|PFS is defined as the interval between the first dose of study medication and the earliest date of PD or death due to any cause. PD was based on radiographic or photographic evidence, and assessments were made by the BICR according to RECIST, version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm. Participants who received anti-cancer therapy prior to the date of documented events, were censored at the last adequate assessment prior to the initiation of therapy. If the participant did not had a documented date of events, PFS and survival were censored at the date of the last adequate assessment|From the first dose of study medication to the earliest date of disease progression (PD) or death due to any cause (up to approximately 17 months)|ITT Population||Months||95% Confidence Interval|Median
812545|NCT01072175|Primary|Progression-free Survival (PFS) as Assessed by the Investigator in Part C (Randomized)|PFS is defined as the interval between the first dose of study medication and the earliest date of PD or death due to any cause. PD was based on radiographic or photographic evidence, and assessments were made by the investigator according to RECIST, version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm. Participants who received anti-cancer therapy prior to the date of documented events, were censored at the last adequate assessment prior to the initiation of therapy. If the participant did not had a documented date of events, PFS and survival were censored at the date of the last adequate assessment.|From the first dose of study medication to the earliest date of disease progression (PD) or death due to any cause (up to approximately 17 months)|ITT Population||Months||Full Range|Median
812567|NCT01072344|Secondary|Frequency, Severity, and Duration of Treatment-emergent Adverse Events.|We will report the frequency, severity, and duration of treatment-emergent adverse events by treatment arm.|26 weeks|During phase II consolidation phase, treatment responders were randomized to either 26 weeks of continuation chamomile therapy or placebo.||Participants|||Count of Participants
812568|NCT01072344|Secondary|The Proportion of Subjects in Each Treatment Condition Who Relapse.|The proportion of subjects in each treatment condition who relapsed after randomization|26 weeks|During phase II consolidation phase, treatment responders were randomized to either 26 weeks of continuation chamomile therapy or placebo.||Participants|||Count of Participants
812546|NCT01072175|Primary|Duration of Response as Assessed by the Investigator and Blinded Independent Central Review (BICR) in Part C (Randomized)|Duration of response for participants with either a CR (the disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis.) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]) is defined as the time from the first documented evidence of a PR or CR until the first documented sign of disease progression (PD) or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm.|First documented evidence of PR or CR until the date of the first documented sign of disease progression or the date of death due to any cause (up to approximately 17 months)|ITT Population. Only those participants who had a CR or PR were analyzed for duration of response.||Months||95% Confidence Interval|Median
812547|NCT01072175|Primary|Number of Participants With BRAF Mutant Metastatic Melanoma With Best Overall Response as Assessed by the Investigator in Part C (Crossover)|Best overall response is defined as complete response (CR: the disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis.) or partial reponse (PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]). Participants with unknown or missing responses were considered as non-responders. To be assigned a status of PR or CR, a confirmatory disease assessment should have been performed no less than 28 days after the criteria for response were first met. Response was evaluated by an investigator as per RECIST, version 1.1.|From the first dose of study medication to the first documented evidence of a confirmed complete response or partial response (up to approximately 15 weeks)|Crossover Population: participants who were randomized to and received at least one dose of dabrafenib monotherapy, and who elected to crossover to combination therapy following disease progression while on monotherapy||Participants|||Number
812548|NCT01072175|Primary|Number of Participants With BRAF Mutant Metastatic Melanoma With Best Overall Response Assessed by Blinded Independent Central Review (BICR) in Part C (Randomized)|Best overall response is defined as complete response (CR: the disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis.) or partial reponse (PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]). Participants with unknown or missing responses were considered as non-responders. To be assigned a status of PR or CR, a confirmatory disease assessment should have been performed no less than 28 days after the criteria for response were first met. Response was evaluated by BICR as per RECIST, version 1.1.|From the first dose of study medication to the first documented evidence of a confirmed complete response or partial response (up to approximately 36 weeks)|ITT Population||Participants|||Number
812549|NCT01072175|Primary|Number of Participants With BRAF Mutant Metastatic Melanoma With Best Overall Response as Assessed by the Investigator in Part C (Randomized)|Best overall response is defined as complete response (CR: the disappearance of all target lesions. Any pathological lymph nodes must be <10 millimeters [mm] in the short axis.) or partial reponse (PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]). Participants with unknown or missing responses were considered as non-responders. To be assigned a status of PR or CR, a confirmatory disease assessment should have been performed no less than 28 days after the criteria for response were first met. Response was evaluated by an investigator as per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.|From the first dose of study medication to the first documented evidence of a confirmed complete response or partial response (up to approximately 47 weeks)|Intent-to-Treat (ITT) Population: all randomized participants regardless of whether or not treatment was administered||Participants|||Number
812550|NCT01072175|Primary|Number of Participants With the Indicated Worst-case Change From Baseline in Heart Rate and Blood Pressure in Part B|Blood pressure and heart rate were summarized according to NCI CTCAE grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to G3 or G4 occurred. Blood pressure measurement included systolic blood pressure (SBP, millimeters of mercury [mmHg]) and diastolic BP (DBP). Heart rate is the measure of heart beats per minute (bpm). Changes in heart rate, either decrease to <60 bpm, change to normal or no change, or increase to >100 bpm are presented.|From Baseline (Day 1) until Follow-up visit (up to approximately 103 weeks)|ATP Population||Participants|||Number
812551|NCT01072175|Primary|Number of Participants With the Indicated Worst-case Grade Change From Baseline in the Indicated Hematology Parameters in Part B|Hematology parameters were summarized according to NCI CTCAE grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to Grade 3 or Grade 4 occurred. For hematology parameters that were not graded according to NCI CTCAE criteria, changes above (High) and below (Low) the normal range were evaluated. Hematology parameters included: lymphocytes decreased, total neutrophils, hemoglobin decreased, white blood cell counts, platelet counts, monocytes, mean corpuscular hemoglobin concentration (MCHC), eosinophils, basophils, mean corpuscular hemoglobin, mean corpuscular volume, red blood cell count, hemotocrit, and reticulocytes.|From Baseline (Day 1) until Follow-up visit (up to approximately 103 weeks)|ATP Population. Only those participants who were available at the indicated time points were analyzed.||Participants|||Number
812569|NCT01072344|Primary|Time to Relapse in Each Treatment Condition.|The primary outcome was time to relapse during continuation therapy, analyzed using Cox proportional hazards. Relapse is dichotomously defined as an increase in CGI/S (a clinician-rated global measure of anxiety's severity) score from ≤ 3 (at study visit 6) to ≥ 4 (on two consecutive scheduled or unscheduled study visits ≥ 2 weeks apart) plus meeting DSM IV-TR criteria for GAD (minus the 6-month time criterion).|26 weeks|All 93 subjects started randomization phase of the study were included in the analysis||weeks||Standard Deviation|Mean
812570|NCT01072357|Secondary|Endothelial Cell Density|Endothelial Cell Density (Assessed at Weeks 26 & 52). Measure of the number of cells present within the endothelium that are responsible for providing the cornea with nourishment.|52 Weeks|||Number of cells per millimeters squared||Standard Deviation|Mean
812552|NCT01072175|Primary|Number of Participants With the Indicated Worst-case Grade (G) Change From Baseline in the Indicated Clinical Chemistry Parameters in Part B|Clinical chemistry parameters were summarized according to National Cancer Institutes (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to Grade 3 or Grade 4 occurred. For clinical chemistry parameters that were not graded according to NCI CTCAE criteria, changes above (High) and below (Low) the normal range were evaluated. Clinical chemistry parameters included: hyponatremia, gamma glutamyltransferase (GGT), phosphorous inorganic, alkaline phosphatase, hyperglycemia, aspartate aminotransferase (AST), hypokalemia, albumin, alanine aminotransferase (ALT), total bilirubin, hyperkalemia, hypoglycemia, creatinine, lactate dehydrogenase, urea/blood urea nitrogen (BUN), bicarbonate, chloride, creatine clearance, total protein, uric acid, and troponin T.|From Baseline (Day 1) until Follow-up visit (up to approximately 103 weeks)|ATP Population. Only those participants who were available at the indicated time points were analyzed.||Participants|||Number
812553|NCT01072175|Primary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) in Part B|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.|From Baseline (Day 1) until Follow-up visit (up to approximately 103 weeks )|All Treated Participants (ATP) Population: all participants who received at least one dose of either dabrafenib or trametinib||Participants|||Number
812554|NCT01072175|Primary|AUC (0-t) and AUC (0-inf) of Dabrafenib and Its Metabolites in Part A|Blood samples for PK analysis of dabrafenib and its metabolites hydroxy-dabrafenib (GSK2285403), carboxy-dabrafenib (GSK2298683) and desmethyl-dabrafenib (GSK2167542) were obtained at pre-dose and at 1, 2, 3, 4, 6, 8, 10, and 24 hours after dabrafenib administration. AUC is defined as the area under the dabrafenib concentration-time curve as a measure of drug exposure. AUC (0-inf) is defined as the area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time. AUC (0-t) is defined as area under the concentration-time curve from time zero (pre-dose) to the last time of quantifiable concentration. Date are reported as geometric least square means.|Day 15|PK Population||ng*hour/mL (ng*hr/mL)||95% Confidence Interval|Geometric Mean
812555|NCT01072175|Primary|Maximum Plasma Concentration (Cmax) of a Single Dose of Dabrafenib Administered Alone and in Combination With Trametnib in Part A|Blood samples for PK analysis of dabrafenib and its the metabolites hydroxy-dabrafenib (GSK2285403), carboxy-dabrafenib (GSK2298683) and desmethyl-dabrafenib (GSK2167542) were obtained at pre-dose and at 1, 2, 3, 4, 6, 8, 10, and 24 hours after dabrafenib administration. From the plasma concentration-time curve, the PK parameter Cmax was determined by standard non-compartmental analysis using WinNonlin. Cmax data are reported as geometric least squares means.|Day 15|Pharmacokinetic (PK) Population: all participants who received at least one dose of either dabrafenib or trametinib and for whom a PK sample was obtained and analyzed||Nanograms per milliliter (ng/mL)||95% Confidence Interval|Geometric Mean
812556|NCT01072188|Primary|Air Blast|Units on a scale using Schiff Cold Air Sensitivity Scale. Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth. According to this analog scale hypersensitivity scores for the stimulated tooth is 0, 1, 2 or 3(The lower the score, the lower the hypersensitivity). 0=No subject response to stimulus, 1=responds but will continue, 2=responds and moves or requests discontinuation, 3=Painful response to stimulus, discontinuation requested.|Immediately after product application|||Units on a scale||Standard Deviation|Mean
812557|NCT01072188|Primary|Hypersensitivity to Touch (Tactile)|Units on a scale: Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 50 grams of force are applied to hypersensitive tooth until pain elicited. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. The higher the score, the higher the hypersensitivity.|Immediately after product application|||Units on a scale||Standard Deviation|Mean
812558|NCT01072201|Primary|Mean Percentage of Plaque Scores|Mean Percentage (%) of dental plaque on all tooth surfaces, including implants and natural teeth. Plaque Scale is 0=no plaque and 1= dental plaque present. Percentage is derived from sum of all plaque scores divided by the number of tooth surfaces scored.|6 Months|||percentage of dental plaque||Standard Deviation|Mean
812559|NCT01072201|Primary|Mean Pocket Depth|Measurement scale: 0 millimeter measurement= no pocket depth. 3, 4, 5, & 6 millimeter are indications of deeper Pocket depth.|6 Months|||Millimeters||Standard Deviation|Mean
812560|NCT01072201|Primary|Bleeding on Probing|Percentage of Bleeding Scale: The bleeding sites are identified by either a 0 or 1. (0=no bleeding & 1= bleeding) The number of spots between teeth that bleed are divided by number of spots between teeth that are scored.|6 months|||Percentage of bleeding sites||Standard Deviation|Mean
812561|NCT01072331|Primary|Change From Baseline in Plasma Glucose Area Under the Curve (AUC) 0 to 2h (Breakfast, Lunch and Dinner)||4 weeks|||mg・h / dL||Standard Error|Least Squares Mean
812562|NCT01072331|Secondary|Change From Baseline in Fasting Plasma Glucose||4 weeks|||mg / dL||Standard Error|Least Squares Mean
812563|NCT01072331|Secondary|Change From Baseline in 24-h Mean Glucose||4 weeks|||mg / dL||Standard Error|Least Squares Mean
812564|NCT01072331|Primary|Change From Baseline in 2-h Postprandial Glucose (Breakfast, Lunch and Dinner)||4 weeks|||mg / dL||Standard Error|Least Squares Mean
812565|NCT01072344|Secondary|Frequency of Early Study Discontinuation in Each Treatment Condition.|This is the # of subjects who discontinued the study during randomization phase due to other reasons.|26 weeks|These are responders at the end of Phase II of the study and were then randomized into Phase III of the study.||Participants|||Count of Participants
812566|NCT01072344|Secondary|Frequency of Discontinuation Symptoms at the Start of Double-blind Therapy in Each Treatment Condition.|Discontinuation emergent signs and symptoms checklist (DESS) is a patient-rated measure of the presence and severity of discontinuation symptoms occurring after medication discontinuation. %|26 weeks|These are responders at the end of Phase II of the study and then were randomized in Phase III of the study||Participants|||Count of Participants
812572|NCT01072396|Secondary|Change From Baseline in Modified Borg Scale Ratings for Dyspnea Intensity at Isotime|Modified Borg Scale is a participant rating of the intensity of dyspnea measured on a scale ranging from 0 (Nothing at all) to 10 (Maximal, most severe ever experienced).|baseline, six weeks of treatment|Full Analysis Set (FAS) includes all patients with at least one baseline (at Visit 3 or 5) and two non-missing post-dosing data (at Visits 4 and 6) for the primary endpoint.||Scores on a scale||Standard Error|Least Squares Mean
812573|NCT01072396|Secondary|Constant Work Rate (CWR) Endurance Time|CWR exercise duration calculated as the length of time of the exercise period|six weeks of treatment|Full Analysis Set (FAS) includes all patients with at least one baseline (at Visit 3 or 5) and two non-missing post-dosing data (at Visits 4 and 6) for the primary endpoint.||seconds||Standard Error|Least Squares Mean
812574|NCT01072396|Primary|Change From Baseline in Inspiratory Capacity (IC) at Isotime|Inspiratory capacity (IC) during CWR exercise testing measured at isotime (isotime was established during CWR exercise testing at baseline). Isotime is the minimum exercise time among all tests. Constant work rate exercise means the exercise is done under constant work rate.|baseline, six weeks of treatment|Full Analysis Set (FAS) includes all patients with at least one baseline (at Visit 3 or 5) and two non-missing post-dosing data (at Visits 4 and 6) for the primary endpoint.||liter||Standard Error|Least Squares Mean
812575|NCT01072409|Primary|CNC Monosyllabic Word Performance - Treated Ear|CNC Word Test is a validated test of open-set word recognition. The test consists of 10 lists with 50 monosyllabic words in each list. Subject responses are scored for both words and phonemes correct in the correct sequence. Subjects will be tested using a configuration of speech at 0º azimuth in quiet.|12 months|||percent correct||Standard Error|Mean
812576|NCT01072448|Secondary|Transition Dyspnea Index (TDI) Total Score at the End of the Study (Week 12, Day 84)|An independent (where feasible), trained assessor interviewed the patient and rated the degree of impairment due to dyspnea on a scale from -3 (major deterioration) to 3 (major improvement) on 3 domains (functional impairment, magnitude of task, and magnitude of effort) in comparison with baseline. A total score of the 3 domains ranged from -9 to 9; minus scores indicate deterioration. The analysis included baseline dyspnea index, FEV1 pre-dose and 10-15 minutes post-dose of albuterol during screening, and FEV1 pre-dose and 50-70 minutes post-dose of ipratropium during screening as covariates.|End of the study (Week 12, Day 84)|Full analysis set: All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).||Units on a scale||Standard Error|Least Squares Mean
812577|NCT01072448|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of the Study (Week 12 + 1 Day, Day 85)|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of albuterol during screening, and FEV1 pre-dose and 50-70 minutes post-dose of ipratropium during screening as covariates.|24 hours post-dose at the end of the study (Week 12 + 1 day, Day 85)|Full analysis set: All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).||Liters||Standard Error|Least Squares Mean
812578|NCT01072500|Secondary|Persistent Mobility Disability (Assessed Every 6 Months)|The assessment of major mobility disability (the inability to complete a 400-m walk test within 15 minutes without sitting and without the help of another person or walker. Use of a cane was acceptable. Participants were asked to walk 400m at their usual pace, without overexerting, on a 20 meter course for 10 laps (40 meters/lap). Participants were allowed to stop for up to 1 minute for fatigue or related symptoms. When MMD could not be objectively measured because of the inability of the participant to come to the clinic and absence of a suitable walking course at the participant’s home, institution, or hospital, an alternative adjudication of the outcome was based on objective inability to walk 4 meters in less than 10 seconds, or self-, proxy-, or medical record–reported inability to walk across a room. If participants met these alternative criteria, they would not be able to complete the 400 m walk within 15 minutes.) at two consecutive time points or MMD followed by death.|Median 2.7 years/Average 2.6 years|||participants|||Number
812579|NCT01072500|Primary|Major Mobility Disability, Defined as Incapacity to Walk 400 Meters|The primary outcome of major mobility disability was defined as the inability to complete a 400-m walk test within 15 minutes without sitting and without the help of another person or walker. Use of a cane was acceptable. Participants were asked to walk 400 m at their usual pace, without overexerting, on a 20 meter course for 10 laps (40 meters/lap). Participants were allowed to stop for up to 1 minute for fatigue or related symptoms. When major mobility disability could not be objectively measured because of the inability of the participant to come to the clinic and absence of a suitable walking course at the participant’s home, institution, or hospital, an alternative adjudication of the outcome was based on objective inability to walk 4 meters in less than 10 seconds, or self-, proxy-, or medical record–reported inability to walk across a room. If participants met these alternative criteria, they would not be able to complete the 400 meter walk within 15 minutes.|Median 2.7 years/Average 2.6 years|||participants|||Number
812580|NCT01072526|Other Pre-specified|Change in Severity of Ocular Discomfort|This will be calculated using a composite score of the primary and secondary outcome measures.|Baseline, 6 weeks|Any data collected was not analyzed because the study was terminated after the PI left the institution. No data is available for reporting as all study personnel have left the institution.|||||
812581|NCT01072526|Secondary|Change in Schirmer Tear Test With Anesthesia Result|Assesses how quickly tears are produced, measured in millimeters (mm) on blotting paper. Greater than 15 mm indicates normal tear production; lower measurement indicates presence of dry eye disease.|Baseline, 6 weeks|Any data collected was not analyzed because the study was terminated after the PI left the institution. No data is available for reporting as all study personnel have left the institution.|||||
812582|NCT01072526|Secondary|Change in Fluorescein Staining Scale|Demonstrates abrasions on cornea and extent of disease. Graded on a scale of 0-5 with 5 being the worst score.|Baseline, 6 weeks|Any data collected was not analyzed because the study was terminated after the PI left the institution. No data is available for reporting as all study personnel have left the institution.|||||
812583|NCT01072526|Secondary|Change in Tear Film Breakup Time|Interval between last blink and break-up of tear film, measured in seconds. Less than 10 seconds = dry eye disease; lower score indicates worse disease.|Baseline, 6 weeks|Any data collected was not analyzed because the study was terminated after the PI left the institution. No data is available for reporting as all study personnel have left the institution.|||||
812584|NCT01072526|Primary|Change in Ocular Surface Disease Index (OSDI)|Measures dry eye disease and effect on vision-related function. Measured on a scale of 0-100, with higher scores indicating greater disability.|Start of treatment, 6 weeks|Any data collected was not analyzed because the study was terminated after the PI left the institution. No data is available for reporting as all study personnel have left the institution.|||||
812585|NCT01072539|Secondary|Percentage of Participants by Microbiologic Response at the Participant Level (Prospective Study Phase)|Definitions: Eradication: None of the baseline isolates were present in a repeat culture taken from the original site of infection (documented) or a clinical response of cure precluded the availability of a specimen for culture (presumed). Persistence: Any baseline isolates were present in a repeat culture obtained from the original site of infection (documented) or culture data were not available for a participant with a clinical response of failure (presumed). Unevaluable: participants who died during therapy for non-infection-related reasons, died for any reason within 2 days after first administration of Tygacil, were lost to follow-up (ie, clinical response was not able to be assessed), or had no baseline isolates.|At the TOC or EOT assessment|Effectiveness Analysis Set from the prospective study phase; n refers to the total munber of participants who had evaluable data.||Percentage of Participants|||Number
812586|NCT01072539|Primary|Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics|Baseline and treatment characteristics included: prospectively/retrospectively collected data, geriatric status (<65 years or >=65 years), age categories, sex, duration of disease, infection site, severity of infection, general, present and past medical history, kidney disorder, liver disorder, total administration period of Tygacil, mean daily dose of Tygacil, past medication and therapy, and concomitant medications.|From the time of the participant’s first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period.|Safety Analysis Set.||Percentage of Participants||95% Confidence Interval|Number
812587|NCT01072539|Secondary|Percentage of Participants With Clinical Response of Cure or Improvement at the TOC or EOT Assessment by Infection Site|Participants whose clinical response was assessed as cure or improvement at the TOC or EOT assessment were considered as “effective” to the treatment of Tygacil .|At the TOC or EOT assessment|Effectiveness Analysis Set.||Percentage of Participants||95% Confidence Interval|Number
812588|NCT01072539|Secondary|Percentage of Participants With Clinical Response of Cure or Improvement at the Test-of-Cure(TOC) or End-of-Treatment (EOT) Assessment|Participants whose clinical response was assessed as cure or improvement at the TOC or EOT assessment were considered as “effective” to the treatment of Tygacil .|At the TOC or EOT assessment|Effectiveness Analysis Set: Participants who received at least one dose of Tygacil and had related effectiveness endpoints evaluated at least.||Percentage of Participants||95% Confidence Interval|Number
812589|NCT01072539|Primary|Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), and Unexpected AEs/ADRs|All AEs reported after start of administration of Tygacil were considered as on treatment and summarized. All AEs, except for those with causal relationship to the study drug assessed as “unlikely”, were considered as ADRs. Unexpected AEs/ADRs were classified by medical review with reference to the approved local product document and confirmed by Pfizer.|From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period.|Safety Anaysis Set||Percentage of Participants|||Number
812590|NCT01072617|Secondary|Positive and Negative Syndrome Scale (PANSS) - General Subscale|Potential therapeutic efficacy was evaluated with the Positive and Negative Syndrome Scale (PANSS) General Subscale, a 16 item subscale measuring the presence/absence and severity of general psychopathology of schizophrenia. The minimum score is 16 and the maximum score is 112, with higher values representing greater psychopathology severity. Therapeutic efficacy was assessed at baseline, after 5 days of treatment, and 1 week post treatment. The overall PANSS total score (minimum = 30, maximum = 210) is computed by summing the positive, negative, and general subscales; and higher values represent more severe schizophrenia psychopathology.|Baseline, 5 days (post-treatment), 1 week post treatment|||percentage of change||Standard Deviation|Mean
812591|NCT01072617|Secondary|Positive and Negative Syndrome Scale (PANSS) - Negative Subscale|Potential therapeutic efficacy was evaluated with the Positive and Negative Syndrome Scale (PANSS) Negative Subscale, a 7 item subscale measuring the presence/absence and severity of negative symptoms of schizophrenia. The minimum score is 7 and the maximum score is 49, with higher values representing greater symptom severity. Therapeutic efficacy was assessed at baseline, after 5 days of treatment, and 1 week post treatment. The overall PANSS total score (minimum = 30, maximum = 210) is computed by summing the positive, negative, and general subscales; and higher values represent more severe schizophrenia psychopathology.|Baseline, 5 days (post-treatment), 1 week post treatment|||percentage of change||Standard Deviation|Mean
812592|NCT01072617|Secondary|Positive and Negative Syndrome Scale (PANSS) - Positive Subscale|Potential therapeutic efficacy was evaluated with the Positive and Negative Syndrome Scale (PANSS) Positive Subscale, a 7 item subscale measuring the presence/absence and severity of positive symptoms of schizophrenia. The minimum score is 7 and the maximum score is 49, with higher values representing greater symptom severity. Therapeutic efficacy was assessed at baseline, after 5 days of treatment, and 1 week post treatment. The overall PANSS total score (minimum = 30, maximum = 210) is computed by summing the positive, negative, and general subscales; and higher values represent more severe schizophrenia psychopathology.|Baseline, 5 days (post-treatment), 1 week post treatment|||percentage of change||Standard Deviation|Mean
812593|NCT01072617|Primary|Adverse Events|Adverse event collection at baseline, daily for 5 days during treatment, every other day by phone until the final assessment at week 1 follow up visit.|3 weeks|||event|||Number
812632|NCT01072773|Primary|Number of Participants With a Confirmed Hematologic Response|"Response that was confirmed on 2 consecutive evaluations during treatment.
Complete Response(CR): Complete disappearance of M-protein from serum and urine on immunofixation, normalization of Free Light Chain (FLC) ratio and <5% plasma cells in bone marrow.
Very Good Partial Response(VGPR): >=90% reduction in serum M-component; Urine M-Component <=100 mg per 24 hours.
Partial Response(PR): >=50% reduction in serum M-component and/or Urine M-Component >=90% reduction or <200 mg per 24 hours; or >=50% decrease in difference between involved and uninvolved FLC levels."|Duration of treatment (up to 12 cycles/months)|||participants|||Number
812594|NCT01072630|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Specific Plan and Intent Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.
The Suicidal Ideation - Specific Plan and Intent question records whether the participant has active suicidal thoughts of killing oneself with details of plan fully or partially worked out and the participant has some intent to carry out the plan since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. This question is asked if the answer to the 'Non-Specific Active Suicidal Thoughts' question was YES, or based on the judgment of the assessor. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
812595|NCT01072630|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Some Intent to Act Without a Specific Plan Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.
The Suicidal Ideation - Some Intent to Act Without a Specific Plan question records whether the participant has active suicidal thoughts of killing oneself and reports having some intent to act on such thoughts since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. This question is asked if the answer to the 'Non-Specific Active Suicidal Thoughts' question was YES, or based on the judgment of the assessor. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
812596|NCT01072630|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Any Methods (Not Plan) Without Intent to Act Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.
The Suicidal Ideation - Any Methods (Not Plan) Without Intent to Act question records whether the participant endorses thoughts of suicide and has thought of at least one method but has no specific plan of action since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. This question is asked if the answer to the 'Non-Specific Active Suicidal Thoughts' question was YES, or based on the judgment of the assessor. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
812597|NCT01072630|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Non-Specific Active Suicidal Thoughts Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.
The Suicidal Ideation - Non-Specific Active Suicidal Thoughts question records whether the participant shares general non-specific thoughts of wanting to end one's life/commit suicide since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
812598|NCT01072630|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Wish to Be Dead Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.
The Suicidal Ideation - Wish to Be Dead question records whether the participant endorses thoughts about a wish to dead or not alive anymore, or a wish to fall asleep and not wake up since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
812599|NCT01072630|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Completed Suicide Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.
The Suicidal Behavior - Completed Suicide question records whether the participant intentionally causing his/her's own death since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
812600|NCT01072630|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Preparatory Acts or Behavior Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.
The Suicidal Behavior - Preparatory Acts or Behavior question records whether the participant exhibited acts or preparations towards imminently making a suicide attempt since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
812601|NCT01072630|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Suicidal Behavior Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.
The Suicidal Behavior - Suicidal Behavior question records whether in the clinician's opinion, the participant exhibited suicidal behavior since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
812602|NCT01072630|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Aborted Attempt Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.
The Suicidal Behavior - Aborted Attempt question records whether the participant began to take steps toward making a suicide attempt but stops themselves before starting the potentially self-injurious act since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
812603|NCT01072630|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Interrupted Attempt Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.
The Suicidal Behavior - Interrupted Attempt question records whether the participant was interrupted by an outside circumstance from starting the potentially self-injurious act with at least some wish to die since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
812604|NCT01072630|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Non-Suicidal Self-Injurious Behavior Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.
The Suicidal Behavior - Non-Suicidal Self-Injurious Behavior question records whether the participant committed a potentially self-injurious act that was not associated with a wish to die since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
812605|NCT01072630|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Actual Attempt Question|The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Actual Attempt question records whether the participant committed a potentially self-injurious act with at least some wish to die since the last visit.|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
812606|NCT01072630|Secondary|Change From Baseline to Endpoint in the Insomnia Severity Index (ISI) Total Score|The ISI is a participant-rated, 7-item questionnaire designed to assess the severity of the participant's insomnia. Each item is ranked 0 (none) through 4 (very severe) and has a descriptor associated with each severity level. Total range is 0 (no insomnia) to 28 (very severe insomnia). Responses to each item are added to obtain a total score to determine the severity of insomnia. Negative change from baseline scores indicate a decrease in severity of insomnia.|Day 0 (baseline), Week 8 or last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with both baseline and during treatment assessments.||units on a scale||Standard Deviation|Mean
812607|NCT01072630|Secondary|Change From Baseline to Endpoint in the Hamilton Anxiety Scale (HAM-A) Total Score|HAM-A measures the severity of anxiety symptoms. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Negative change from baseline scores indicate a decrease in severity of anxiety.|Day 0 (baseline), Week 8 or last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with both baseline and during treatment assessments.||units on a scale||Standard Deviation|Mean
812670|NCT01073163|Secondary|Mean Change From Baseline in QTcF at 1 Hour Postinfusion|On Day 2 of Cycle 1, three ECGs were collected 15 minutes prior to any study drug administration. The baseline ECG interval value was obtained by averaging these 3 ECGs, and was compared to the average of the 3 ECGs taken on treatment with bendamustine 1 hour postinfusion.|Baseline ECGs (Day 2 of Cycle 1): 15 minutes prior to bendamustine infusion. Postinfusion ECGs (Day 2 of Cycle 1): 1 hour postinfusion.|ECG Analysis Set: all enrolled participants in study who received at least 1 dose of study drug and with at least 1 available baseline and 1 on-treatment ECG.||ms||Standard Deviation|Mean
812608|NCT01072630|Secondary|Change From Baseline to Endpoint in the Young Mania Rating Scale Total Score|The YMRS is a clinician-rated, 11-item checklist used to measure the severity of manic episodes. Information for assigning scores is gained from the participant's subjective reported symptoms over the previous 48 hours and from clinical observation during the interview. Seven items are ranked 0 through 4 and have descriptors associated with each severity level. Four items (irritability, speech, content, and disruptive-aggressive behavior) are scored 0 through 8 and have descriptors for every second increment. The total scale is 0-60. A score of ≤12 indicates remission of manic symptoms, and higher scores indicate greater severity of mania. Negative change from baseline scores indicate a decrease in severity of mania.|Day 0 (baseline), Week 8 or last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug.||units on a scale||Standard Deviation|Mean
812609|NCT01072630|Secondary|Participants With Treatment-Emergent Adverse Events (TEAE)|"AEs were graded by the investigator for severity on a three-point scale: mild, moderate and severe. Causality is graded as either related or not related. A serious adverse event (SAE) is an AE resulting in death, a life-threatening adverse event, hospitalization, a persistent or significant disability/incapacity, a congenital anomaly/birth defect, or an important medical event that may require medical intervention to prevent any of the previous results.
Protocol-defined adverse events requiring expedited reporting included skin rash, hypersensitivity reaction, emergent suicidal ideation or suicide attempt, and psychosis."|Day 1 to Week 9|The safety analysis set includes randomized participants who took 1 or more doses of study drug||participants|||Number
812610|NCT01072630|Secondary|Change From Baseline to Weeks 4, 8 and Endpoint in the Global Assessment for Functioning (GAF) Scale|The Global Assessment of Functioning (GAF) is a numeric scale (1 through 100) used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of adults, e.g., how well or adaptively one is meeting various problems-in-living. Ratings of 1 - 10 mean the participant is in persistent danger of severely hurting self or others (e.g., recurrent violence) or persistent inability to maintain minimal personal hygiene or serious suicidal act with clear expectation of death. Ratings of 91 - 100 indicate no symptoms, and the participant exhibits superior functioning in a wide range of activities, life's problems never seem to get out of hand, is sought out by others because of his or her many positive qualities. Positive change from baseline values indicate improvement in functioning.|Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The number of participants is those with a nonmissing value at that visit. Endpoint was the last observed postbaseline data.||units on a scale||Standard Deviation|Mean
812611|NCT01072630|Secondary|Change From Baseline to Different Treatment Weeks in the Clinical Global Impression of Severity (CGI-S) for Depression|The CGI-S is an observer-rated scale that measures illness severity on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). Negative change from baseline values indicate improvement in the severity of depression.|Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The number of participants is those with a nonmissing value at that visit. Endpoint was the last observed postbaseline data.||units on a scale||Standard Deviation|Mean
812612|NCT01072630|Secondary|Change From Baseline to Different Treatment Weeks in the Total Score From the 16-Item Quick Inventory of Depressive Symptomatology-Clinician-Rated (QIDS-C16)|The QIDS-C16 was derived from specified items in the IDS-C30, clinician-rated scale to assess the severity of a participant's depressive symptoms. Total scores range from 0-27, with a score of 0 indicating no depression and a score of 27 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression.|Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The number of participants at each visit is those with a nonmissing value at that visit. Endpoint was the last observed postbaseline data.||units on a scale||Standard Deviation|Mean
812613|NCT01072630|Secondary|Change From Baseline to Different Treatment Weeks in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)|"The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.
Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression."|Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. Participants are included in the analysis at each timepoint if they have a nonmissing value at that visit. Endpoint for analyses was the last observed postbaseline data.||units on a scale||Standard Deviation|Mean
812614|NCT01072630|Secondary|Percentage of Participants in Remission At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score|"A participant in remission was defined as a participant with an IDS-C30 total score of 11 or less.
The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.
Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression."|Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The denominator for calculating the percentages at each visit is the number of participants with a nonmissing value at that visit. Endpoint was the last observed postbaseline data.||percentage of participants|||Number
812723|NCT01073930|Secondary|Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Were You Able to Consume the Entire Prep As Instructed?|Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 2-point scale: yes, no|Day 2|Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Two participants either did not complete the questionnaire or did not answer this question.||percentage of participants|||Number
812615|NCT01072630|Secondary|Percentage of Responders At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score|"A responder is a participant with a ≥50% decrease or greater from baseline in the total score of the IDS-C30. The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.
Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression."|Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The denominator for calculating the percentages at each visit is the number of participants with a nonmissing value at that visit. Endpoint was the last observed postbaseline data.||percentage of participants|||Number
812616|NCT01072630|Primary|Change From Baseline to Week 8 in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)|"The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.
Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression."|Day 0 (baseline), Week 8|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
812617|NCT01072643|Secondary|To Demonstrate That DEX is a Safe Sedative in Pediatric Subjects With PHTN||24 hours||||||
812618|NCT01072643|Secondary|To Obtain Pharmacokinetic Data in This Population||6 hours||||||
812619|NCT01072643|Secondary|To Quantify the Effect of DEX on PVR in Pediatric Subjects With Pulmonary Hypertension and Its Dependence on Baseline PVR||Every individual patient will be studied over maximum of 4 hours during the dose escalation phase. This part of the study will be completed in 1 year||||||
812620|NCT01072643|Secondary|Efficacy of Sedation With DEX||Subjects will participate in a dose escalation study which will define minimal effective dose that results in effective sedation in ≥ 7 out of 8 patients in that dose cohort. Maximum upto 4 hours||||||
812621|NCT01072643|Primary|The Primary Endpoint Will be the Change in PVR in Wood Units|Pulmonary vascular resistance (PVR) in Wood units calculated during cardiac catheterization;|For each subject PVR will be measured by cardiac catheterization at T0 ( baseline measurement) , after DEX bolus (T1) which is given over 10 minutes and after 30 mins after start of the DEX infusion (T2) - Maximum upto 4 hours|||wood units|||Number
812622|NCT01072656|Secondary|Number of Patient Who Had >50% Reduction in VAS.|Patients report reduction in the VAS (Visual Analogue Scale Ranging from 0-10, 0 meaning no pain and 10 meaning worst pain imaginable) at the end of the open label phase (24 months post randomization f/u) compared to the pre-implantation baseline.|Baseline and 24 months|||Participants|||Count of Participants
812623|NCT01072656|Secondary|Number of Participants Who Would Undergo the Procedure Again.|A positive answer from patients receiving active stimulation at the end of the open label phase of the study to the question: ‘would you undergo this procedure again if you were to get the same benefits you experienced?’|End of Open Label Phase (24 months)|||Participants|||Count of Participants
812624|NCT01072656|Secondary|Number of Participants Who Had 50% Improvement in PDI|A 50% improvement in pain related disability (as assessed by the pain disability index) at the end of the open label phase compared to the pre-implantation baseline. The PDI ranges from 0-10 with 0 equaling no disability and 10 equaling worst disability.|24 months post randomization follow up|||Participants|||Count of Participants
812625|NCT01072656|Primary|Number of Participants With 50% Improvement in Pain Related Disability (as Assessed by the Pain Disability Index)|Pain Disability Index (PDI) directly measures disability related to the main components of daily life function and has been validated for thalamic pain syndrome. Range is 0 (no disability) to 10 (worst disability). The components are Family/Home Responsibilities, Recreation, Social Activity, Sexual Behavior, Life-support Activity, Occupation, & Self-care. This is an average score of the 3 month period for each Active and Sham phase.|Blinded stimulation phase (3 Months)|||participants|||Number
812626|NCT01072669|Primary|Digital Micro-vascular Flow|Change in digital micro-vascular flow measured by LDPI in patients with Raynaud’s phenomenon (RP) and digital ischemia secondary to SSc at 1 week and 12 weeks|Baseline and 12 weeks|Assuming a standard deviation of 0.40, and use of a two-sample t-test with significance level of 0.05, there will be 80% power to detect differences in the change from baseline of at least 0.65 units if moderate correlation (r=0.50) exists, and 0.45 units if strong correlation (r=0.75) exists between treated||perfusion unit||95% Confidence Interval|Mean
812627|NCT01072773|Secondary|Duration of Response|Duration of response will be calculated from the date of first evidence of response until the date of progression in the subset of patients with confirmed hematologic responses.|Duration of Study (up to 5 years)|Neither participant achieved a response. Therefore, no duration of response calculation was performed.|||||
812628|NCT01072773|Secondary|Time to Disease Progression|Time to disease progression is defined as the time from registration to the earliest date of documented disease progression. If a patient dies without a documentation of disease progression the patient will be considered to have had tumor progression at the time of their death|Duration of Study (up to 5 years)|||Months||95% Confidence Interval|Median
812629|NCT01072773|Secondary|Overall Survival|Survival time is defined as the time from registration to death due to any cause.|Duration of Study (up to 5 years)|||Months||95% Confidence Interval|Median
812630|NCT01072773|Secondary|Number of Participants With an Organ Response.|The number of patients that acheived a response in an affected organ.|Duration on treatment (up to 12 cycles/months)|||participants|||Number
812631|NCT01072773|Secondary|Number of Participants With Treatment Related Adverse Events.|"Adverse events (AE) that are classified as either possibly, probably, or definitely related to study treatment according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE version 3.0). The maximum grade for each type of AE will be recorded for each patient. Grade refers to the severity of the AE.
Grade 1: Mild AE, Grade 2: Moderate AE, Grade 3: Severe AE, Grade 4: Life-threatening or disabling AE, Grade 5: Death related AE
Adverse events will be assessed using NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0."|Duration on treatment (up to 12 cycles/months)|||participants|||Number
812633|NCT01072877|Secondary|Change From Baseline at 8 Weeks Post Treatment in IPR-V3 Score- Physician Photographic Review of Appearance|The Independent Photography Review – Visible Varicose Veins (IPR-V3) instrument is a 5-point scale used to assess the appearance of a patient’s visible varicose veins. At baseline and Week 8, standardized digital photographs were taken of the medial view of the patient's target leg, from groin to ankle. An independent photography review panel, consisting of 3 trained, blinded clinicians evaluated the appearance of the patient's visible varicose veins using the IPR-V3 instrument's 5-point scale (where 0=none to 4=very severe visible varicose veins).|8 weeks post treatment|Population consists of all patients who had a baseline and on-treatment assessment.||units on a scale||Standard Error|Mean
812634|NCT01072877|Secondary|Change From Baseline to 8 Weeks in Appearance as Rated by Patient (PA-V3)|The Patient Self-assessment of Visible Varicose Veins (PA-V3) instrument is a 5-point scale used by patients to evaluate the appearance of their visible varicose veins. On this single-item paper questionnaire, the instructions included a diagram of the medial view of a leg with the area between the ankle and the groin circled. The patient was instructed to choose 1 of 5 response options that best described the appearance of the visible varicose veins of the leg that was treated in the study. The patient was instructed not to consider the appearance of the leg outside the circled area or of any spider veins. Possible responses ranged from “Not at all noticeable” (a score of 0) to “Extremely noticeable” (a score of 4).|8 weeks|||units on a scale||Standard Error|Mean
812635|NCT01072877|Primary|Change in Patient-reported Symptoms of Varicose Veins (VVSymQ Score)|"The 9 varicose vein symptoms were to be assessed and graded on a 6-point (i.e., 0-5) duration scale and an 11-point (i.e., 0-10) intensity scale, and the patient’s level of activity for that day was to be assessed and graded on the 6-point (i.e., 0-5) duration scale. The 9 varicose vein symptoms assessed using the e-diary were derived from the first question of the modified Venous Insufficiency Epidemiologic and Economic Study-Quality of Life/Symptoms (VEINES-QOL/Sym) instrument. The VVSymQ is a subset of 5 VEINESQOL/ Sym items that have been determined in earlier studies to be most important to patients (heaviness, achiness, swelling, throbbing, and itching).
The daily VVSymQ score is the sum of the duration scores for these 5 symptoms (scores range from 0 to 25, with the lower end of the range being an indicator of less symptom intensity, and the higher end being an indicator of higher intensity).
At Visit 2/baseline, Week 8, scores were calculated"|Week 8|||units on a scale||Standard Error|Mean
812636|NCT01072929|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Specific Plan and Intent Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.
The Suicidal Ideation - Specific Plan and Intent question records whether the participant has active suicidal thoughts of killing oneself with details of plan fully or partially worked out and the participant has some intent to carry out the plan since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. This question is asked if the answer to the 'Non-Specific Active Suicidal Thoughts' question was YES, or based on the judgment of the assessor. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
812637|NCT01072929|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Some Intent to Act Without a Specific Plan Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.
The Suicidal Ideation - Some Intent to Act Without a Specific Plan question records whether the participant has active suicidal thoughts of killing oneself and reports having some intent to act on such thoughts since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. This question is asked if the answer to the 'Non-Specific Active Suicidal Thoughts' question was YES, or based on the judgment of the assessor. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
812638|NCT01072929|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Any Methods (Not Plan) Without Intent to Act Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.
The Suicidal Ideation - Any Methods (Not Plan) Without Intent to Act question records whether the participant endorses thoughts of suicide and has thought of at least one method but has no specific plan of action since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. This question is asked if the answer to the 'Non-Specific Active Suicidal Thoughts' question was YES, or based on the judgment of the assessor. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
812639|NCT01072929|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Non-Specific Active Suicidal Thoughts Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.
The Suicidal Ideation - Non-Specific Active Suicidal Thoughts question records whether the participant shares general non-specific thoughts of wanting to end one's life/commit suicide since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
824786|NCT01178268|Secondary|Follow-up Late Loss|This is one of the Secondary Angiographic Endpoint.|≥13 months.|The number of participants with angiographic follow up available was analysed.||Millimeter|Participants|Standard Deviation|Mean
812640|NCT01072929|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Wish to Be Dead Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.
The Suicidal Ideation - Wish to Be Dead question records whether the participant endorses thoughts about a wish to dead or not alive anymore, or a wish to fall asleep and not wake up since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
812641|NCT01072929|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Completed Suicide Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.
The Suicidal Behavior - Completed Suicide question records whether the participant intentionally causing his/her's own death since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
812642|NCT01072929|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Preparatory Acts or Behavior Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.
The Suicidal Behavior - Preparatory Acts or Behavior question records whether the participant exhibited acts or preparations towards imminently making a suicide attempt since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
812643|NCT01072929|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Suicidal Behavior Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.
The Suicidal Behavior - Suicidal Behavior question records whether in the clinician's opinion, the participant exhibited suicidal behavior since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
812644|NCT01072929|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Aborted Attempt Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.
The Suicidal Behavior - Aborted Attempt question records whether the participant began to take steps toward making a suicide attempt but stops themselves before starting the potentially self-injurious act since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
812645|NCT01072929|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Interrupted Attempt Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.
The Suicidal Behavior - Interrupted Attempt question records whether the participant was interrupted by an outside circumstance from starting the potentially self-injurious act with at least some wish to die since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
812646|NCT01072929|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Non-Suicidal Self-Injurious Behavior Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.
The Suicidal Behavior - Non-Suicidal Self-Injurious Behavior question records whether the participant committed a potentially self-injurious act that was not associated with a wish to die since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
812724|NCT01073930|Secondary|Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: How Easy or Difficult Was It To Consume the Study Drug?|Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 5-point scale: very easy, easy, tolerable, difficult, very difficult|Day 2|Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Three participants either did not complete the questionnaire or did not answer this question.||percentage of participants|||Number
812647|NCT01072929|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Actual Attempt Question|The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Actual Attempt question records whether the participant committed a potentially self-injurious act with at least some wish to die since the last visit.|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
812648|NCT01072929|Secondary|Change From Baseline to Endpoint in the Insomnia Severity Index (ISI) Total Score|The ISI is a participant-rated, 7-item questionnaire designed to assess the severity of the participant’s insomnia. Each item is ranked 0 (none) through 4 (very severe) and has a descriptor associated with each severity level. Total range is 0 (no insomnia) to 28 (very severe insomnia). Responses to each item are added to obtain a total score to determine the severity of insomnia. Negative change from baseline scores indicate a decrease in severity of insomnia.|Day 0 (baseline), last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with both baseline and during treatment assessments.||units on a scale||Standard Deviation|Mean
812649|NCT01072929|Secondary|Change From Baseline to Endpoint in the Hamilton Anxiety Scale (HAM-A) Total Score|HAM-A measures the severity of anxiety symptoms. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0–56, where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Negative change from baseline scores indicate a decrease in severity of anxiety.|Day 0 (baseline), last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with both baseline and during treatment assessments.||units on a scale||Standard Deviation|Mean
812650|NCT01072929|Secondary|Change From Baseline to Endpoint in the Young Mania Rating Scale (YMRS) Total Score|The YMRS is a clinician-rated, 11-item checklist used to measure the severity of manic episodes. Information for assigning scores is gained from the participant's subjective reported symptoms over the previous 48 hours and from clinical observation during the interview. Seven items are ranked 0 through 4 and have descriptors associated with each severity level. Four items (irritability, speech, content, and disruptive-aggressive behavior) are scored 0 through 8 and have descriptors for every second increment. The total scale is 0-60. A score of ≤12 indicates remission of manic symptoms, and higher scores indicate greater severity of mania. Negative change from baseline scores indicate a decrease in severity of mania.|Day 0 (baseline), last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with both baseline and during treatment assessments.||units on a scale||Standard Deviation|Mean
812651|NCT01072929|Secondary|Participants With Treatment-Emergent Adverse Events (TEAE)|"AEs were graded by the investigator for severity on a three-point scale: mild, moderate and severe. Causality is graded as either related or not related. A serious adverse event (SAE) is an AE resulting in death, a life-threatening adverse event, hospitalization, a persistent or significant disability/incapacity, a congenital anomaly/birth defect, or an important medical event that may require medical intervention to prevent any of the previous results.
Protocol-defined adverse events requiring expedited reporting included skin rash, hypersensitivity reaction, emergent suicidal ideation or suicide attempt, and psychosis."|Day 1 to Week 9|The safety analysis set includes randomized participants who took 1 or more doses of study drug.||participants|||Number
812652|NCT01072929|Secondary|Change From Baseline to Weeks 4, 8 and Endpoint in the Global Assessment for Functioning (GAF) Scale|The Global Assessment of Functioning (GAF) is a numeric scale (1 through 100) used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of adults, e.g., how well or adaptively one is meeting various problems-in-living. Ratings of 1 - 10 mean the participant is in persistent danger of severely hurting self or others (e.g., recurrent violence) or persistent inability to maintain minimal personal hygiene or serious suicidal act with clear expectation of death. Ratings of 91 - 100 indicate no symptoms, and the participant exhibits superior functioning in a wide range of activities, life's problems never seem to get out of hand, is sought out by others because of his or her many positive qualities. Positive change from baseline values indicate improvement in functioning.|Day 0 (baseline), Weeks 4, 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The number of participants is those with a nonmissing value at that visit. Endpoint was the last observed postbaseline data.||units on a scale||Standard Deviation|Mean
812653|NCT01072929|Secondary|Change From Baseline to Different Treatment Weeks in the Clinical Global Impression of Severity (CGI-S) for Depression|The CGI-S is an observer-rated scale that measures illness severity on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). Negative change from baseline values indicate improvement in the severity of depression.|Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The number of participants is those with a nonmissing value at that visit. Endpoint was the last observed postbaseline data.||units on a scale||Standard Deviation|Mean
812736|NCT01073943|Primary|Percentage of Participants Classified as Successes (Excellent and Good Ratings) According to the Aronchick Scale As Assessed by a Blinded Gastroenterologist|Overall colon cleansing was assessed by a blinded gastroenterologist during the colonoscopy using the Aronchick scale. The Aronchick scale is a 4-step rating scale: inadequate, fair, good, and excellent. Excellent is defined as >90% of mucosa seen, mostly liquid stool, minimal suctioning needed for adequate visualization. Good is defined as >90% of mucosa seen, mostly liquid stool, significant suctioning needed for adequate visualization.|Day 2|Intent-to-treat population of randomized and treated participants with efficacy assessments performed.||percentage of participants|||Number
812654|NCT01072929|Secondary|Change From Baseline to Different Treatment Weeks in the Total Score From the 16-Item Quick Inventory of Depressive Symptomatology-Clinician-Rated (QIDS-C16)|The QIDS-C16 was derived from specified items in the IDS-C30, clinician-rated scale to assess the severity of a participant's depressive symptoms. Total scores range from 0-27, with a score of 0 indicating no depression and a score of 27 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression.|Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The number of participants at each visit are those with a nonmissing value at that visit. Endpoint was the last observed postbaseline data.||units on a scale||Standard Deviation|Mean
812655|NCT01072929|Secondary|Change From Baseline to Different Treatment Weeks in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)|"The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.
Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression."|Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. Participants are included in the analysis at each timepoint if they have a nonmissing value at that visit. Endpoint for analyses was the last observed postbaseline data.||units on a scale||Standard Deviation|Mean
812656|NCT01072929|Secondary|Percentage of Participants in Remission At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score|"A participant in remission was defined as a participant with an IDS-C30 total score of 11 or less.
The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.
Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression."|Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The denominator for calculating the percentages at each visit is the number of participants with a nonmissing value at that visit. Endpoint was the last observed postbaseline data.||percentage of participants|||Number
812657|NCT01072929|Secondary|Percentage of Responders At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score|"A responder is a participant with a ≥50% decrease or greater from baseline in the total score of the IDS-C30. The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.
Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression."|Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The denominator for calculating the percentages at each visit is the number of participants with a nonmissing value at that visit. Endpoint was the last observed postbaseline data.||percentage of participants|||Number
812658|NCT01072929|Primary|Change From Baseline to Week 8 in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)|"The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.
Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression."|Day 0 (baseline), Week 8|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
812659|NCT01073163|Secondary|Worst Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Grades for Hematology Laboratory Tests Results Overall|Grade 1=Mild, 2=Moderate, 3=Severe/medically significant, 4=Life-threatening. Overall is defined as the worst postbaseline grade value for each patient and laboratory test across all cycles. Only postbaseline grades are summarized. If absolute neutrophil count (ANC) and neutrophils absolute (ABS) were both measured, the worse grade value from the two was summarized. Otherwise the worst ANC grade value or the worst neutrophils ABS grade value was summarized. WBC=white blood cell; LLN=lower limit of normal|Adverse events were collected throughout the study and up to 30 days after the last dose of study drug. The median number of 28-day cycles was 6.0. The median duration of the treatment period was 143 days.|Safety Analysis Set: enrolled participants who received 1 or more doses of study drug.||participants|||Number
812660|NCT01073163|Secondary|Eastern Cooperative Oncology Group (ECOG) Performance Status at Endpoint|The investigator assessed each patient’s ECOG performance status according to the ECOG scale at screening, on Day 1 of each treatment cycle, and at the end-of-treatment visit. Scale scores were: 0=fully active, able to carry on all pre-disease performance without restriction; 1=restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; 2=ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours; 3=capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4=completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; 5=dead. Any change in score to a higher value signifies worsening, and any change to a lower value signifies improvement.|End of study. The median number of 28-day cycles was 6.0. The median duration of the treatment period was 143 days.|Safety Analysis Set: enrolled participants who received 1 or more doses of study drug.||participants|||Number
812875|NCT01074554|Secondary|Change in Modified Sarcoidosis Activity and Severity Index (SASI) at Completion of Therapy.|Characterization of lesion severity was conducted using Modified Sarcoidosis Activity and Severity Index (SASI), measuring erythema, induration and desquamation. The modification was that the same scale was applied to any part of the body, instead of the face alone. The scale range is 0 (no problem) to 72 (very severe).|Baseline to 8 weeks|||units on a scale||Standard Deviation|Mean
812661|NCT01073163|Secondary|Overview of Adverse Events|Adverse event (AE)=any untoward medical occurrence in a patient administered study drug that develops or worsens in severity during the conduct of a clinical study of a pharmaceutical product and does not necessarily have a causal relationship to the study drug. Treatment-related AEs=those that began or worsened after treatment with study drug. AE severity was graded according to the National Cancer Institute's Common Terminology Criteria for AEs (grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening, grade 5= death). Relationship of an AE to study drug was categorized as definite, probable, possible, unlikely, or not related. Serious AE (SAE)=one that occurred at any dose that resulted in any of the following outcomes or actions: death; a life-threatening adverse event; inpatient hospitalization or prolongation of existing hospitalization; a persistent or significant disability/incapacity; a congenital anomaly/birth defect; or an otherwise important medical event.|Adverse events were collected throughout the study and up to 30 days after the last dose of study drug. The median number of 28-day cycles was 6.0. The median duration of the treatment period was 143 days.|Safety Analysis Set: enrolled participants who received 1 or more doses of study drug.||participants|||Number
812662|NCT01073163|Secondary|Percentage of Participants With Overall Response|Overall Response was comprised of those participants who had Complete Response (CR) plus those who had Partial Response (PR), as defined by the International Working Group (IWG) Revised Response Criteria For Malignant Lymphoma. Results are presented for participants with non-Hodgkin lymphoma and mantle cell lymphoma as well as all participants.|The median number of 28-day cycles was 6.0. The median duration of the treatment period was 143 days.|Full Analysis Set: all enrolled participants who received at least 1 dose of both bendamustine and rituximab and who had both a baseline and at least 1 postbaseline tumor response evaluation.||percentage of participants||95% Confidence Interval|Number
812663|NCT01073163|Secondary|Percentage of Participants With Complete Response (CR)|Complete response, as defined by the International Working Group (IWG) Revised Response Criteria For Malignant Lymphoma. Results are presented for participants with non-Hodgkin lymphoma and mantle cell lymphoma as well as all participants.|The median number of 28-day cycles was 6.0. The median duration of the treatment period was 143 days.|Full Analysis Set: all enrolled participants who received at least 1 dose of both bendamustine and rituximab and who had both a baseline and at least 1 postbaseline tumor response evaluation.||percentage of participants||95% Confidence Interval|Number
812664|NCT01073163|Secondary|Rituximab Concentrations at 0.5 Hours, 24 Hours, and 7 Days Postinfusion||Day 1 of Cycle 1: prior to start of rituximab infusion, immediately postinfusion. Day 2 of Cycle 1: 15 minutes prior to the start of the bendamustine infusion. Day 7 and Day 14: anytime. Day 1 of Cycle 2: prior to start of rituximab infusion.|Pharmacokinetic Analysis Set: all enrolled participants in study who received at least 1 dose of study drug and with at least 1 quantifiable serum concentration of rituximab.||mcg/mL||Full Range|Median
812665|NCT01073163|Secondary|Model-predicted Bayesian Bendamustine Clearance in the Presence of Rituximab|Boxplots of model-predicted Bayesian bendamustine clearance (CL) values in the presence of rituximab were generated based on the administered bendamustine doses, rate of infusion, and sample times.|Day 1 of Cycle 1: prior to start of bendamustine infusion, immediately postinfusion, 15 minutes and 30 minutes postinfusion. Day 2 of Cycle 1: 15 minutes prior to start of bendamustine infusion, 15 minutes, 30 minutes, 1, 3, and 5 hours postinfusion.|Pharmacokinetic Analysis Set: all enrolled participants in study who received at least 1 dose of study drug and with at least 1 quantifiable bendamustine plasma concentration.||L/h||Full Range|Median
812666|NCT01073163|Secondary|Change From Baseline in QTcF at Maximum Concentration (Cmax) of Bendamustine and Its Metabolites (M3 and M4)|Results from a pharmacokinetic-pharmacodynamic model to show the relationship of the overall predicted change from Baseline in QTcF at the average Cmax of bendamustine and its metabolites M3 and M4.|Baseline ECGs (Day 2 of Cycle 1): 15 minutes prior to bendamustine infusion. Postinfusion ECGs (Day 2 of Cycle 1): at the end of the 30-minute infusion and 1 hour postinfusion.|Pharmacokinetic-pharmacodynamic Analysis Set: all enrolled participants in study who received at least 1 dose of study drug and with at least 1 available baseline and 1 on-treatment ECG and at least 1 ECG with a time-matched plasma concentration pair.||ms||95% Confidence Interval|Mean
812667|NCT01073163|Secondary|Number of Participants With Treatment-Emergent Cardiac Disorders|Number of participants with cardiac disorders overall, with severity from grades 1 (mild) to grade 4 (severe), according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening, grade 5= death). Participants may have reported more than 1 event.|Adverse events were collected throughout the study and up to 30 days after the last dose of study drug. The median number of 28-day cycles was 6.0. The median duration of the treatment period was 143 days.|Safety Analysis Set: enrolled participants who received 1 or more doses of study drug.||participants|||Number
812668|NCT01073163|Secondary|Number of Participants With New Onset ECG Waveform Morphological Changes|The core ECG laboratory cardiologist assessed all leads in the ECGs and defined morphological changes. Changes from baseline (looking at each of the 3 ECGs at Day 2 Cycle 1 individually and the ECGs at all on-treatment time points individually) were noted for the following events: atrial fibrillation or flutter; second degree heart block; third degree heart block; complete right bundle branch block; complete left bundle branch block; ST segment depression; T wave abnormalities (negative T waves only); myocardial infarction pattern; any new abnormal U waves.|Baseline ECGs (Day 2 of Cycle 1): 15 minutes prior to bendamustine infusion. Postinfusion ECGs (Day 2 of Cycle 1): at the end of the 30-minute infusion and 1 hour postinfusion.|ECG Analysis Set: all enrolled participants in study who received at least 1 dose of study drug and with at least 1 available baseline and 1 on-treatment ECG.||participants|||Number
812669|NCT01073163|Secondary|Number of Participants With QTcF New Outlier Events at End of Infusion and 1 Hour Postinfusion|Participants were considered to have an outlier ECG value based on the most extreme value across each of the time points. “New” means not present at baseline and becomes present on at least 1 on-treatment ECG time point. A participant had a new outlier event (500) if the maximum QTcF was >500 ms while their baseline was <=500 ms, or had an outlier event (480) if the maximum QTcF was >480 ms while their baseline was <= 480 ms. QTcF in the 30-60 ms or >60 ms categories were also considered outliers.|Baseline ECGs (Day 2 of Cycle 1): 15 minutes prior to bendamustine infusion. Postinfusion ECGs (Day 2 of Cycle 1): at the end of the 30-minute infusion and 1 hour postinfusion.|ECG Analysis Set: all enrolled participants in study who received at least 1 dose of study drug and with at least 1 available baseline and 1 on-treatment ECG; n=number of participants with measurement at given time point.||participants|||Number
812671|NCT01073163|Primary|Mean Change From Baseline in QT Interval as Corrected by the Fridericia Method (QTcF) at End of Infusion|On Day 2 of Cycle 1, three electrocardiograms (ECGs) were collected 15 minutes prior to any study drug administration. The baseline ECG interval value was obtained by averaging these 3 ECGs, and was compared to the average of the 3 ECGs taken on treatment with bendamustine at the end of the infusion.|Baseline ECGs (Day 2 of Cycle 1): 15 minutes prior to bendamustine infusion. Postinfusion ECGs (Day 2 of Cycle 1): at the end of the 30-minute infusion.|ECG Analysis Set: all enrolled participants in study who received at least 1 dose of study drug and with at least 1 available baseline and 1 on-treatment ECG; n=number of participants with measurement at given time point.||milliseconds (ms)||Standard Deviation|Mean
812672|NCT01073267|Primary|Objective Response Rate|"Objective response rate defined as the proportion of participants achieving complete clinical response (CCR) and partial response (PR) (i.e. overall response (OR)) as assessed by the modified Severity-Weighted Assessment Tool (mSWAT).
Clinical response (according to mSWAT) are documented as stable disease (SD), partial response (PR), complete clinical response (CCR), or progressive disease (PD) as defined: Complete clinical response (CCR): no evidence of cutaneous disease on exam, confirmed at 4 week time point; Partial response (PR): ≥ 50% decrease of modified SWAT score compared to baseline score, confirmed at 4 week time point; Stable disease (SD): Neither CR, PR, or PD, i.e. change from baseline is less than 50% decrease, but also less than 25% increase in mSWAT score compared to nadir score; Progressive disease (PD): ≥ 25% increase in modified SWAT score compared with nadir score."|Baseline and at least 2 months|Intent to treat population.||proportion of participants|||Number
812673|NCT01073293|Secondary|Percentage of Participants Who Seroconvert for Each of the HPV Types|Blood was drawn at Month 7 and assayed to determine whether or not a participant had achieved seroconversion for the HPV types. The lower limit of the titer (milli Merck U/mL) considered seropositive was as follows: HPV Type 6: >=30, HPV Type 11: >=16; HPV Type 16: >=20, HPV Type 18: >=24, HPV Type 31: >=10, HPV Type 33: >=8, HPV Type 45: >=8, HPV Type 52: >=8, and HPV Type 58: >=8.|Month 7|The per-protocol population included participants who received all study vaccinations, were seronegative to HPV on Day 1, and had serum samples available for evaluation of the endpoint||Percentage of participants|||Number
812674|NCT01073293|Primary|Percentage of Participants Who Achieve Acceptable Titers of Anti-Poliovirus Antibody|For the Concomitant Vaccination group, serum samples were collected 4 weeks after the Day 1 vaccination; for the Non-concomitant Vaccination group, serum samples were collected 4 weeks after the Month 1 vaccination. Titers of neutralizing antibody to poliovirus type 1, 2, and 3 were measured using a microneutralization assay. Serial dilutions of sera were incubated with type-specific standard poliovirus and sensitive cells. Neutralization of the virus was measured by cell staining. Acceptable titers were defined as neutralization at >=1:8 dilution of serum.|4 weeks following Day 1 (Concomitant) or Month 1 (Non-concomitant) vaccination|The per-protocol population included participants who received vaccination and had serum samples available for evaluation of the endpoint||Percentage of participants||95% Confidence Interval|Number
812675|NCT01073293|Primary|Geometric Mean Titers of Pertussis Antibody Responses|For the Concomitant Vaccination group, serum samples were collected 4 weeks after the Day 1 vaccination; for the Non-concomitant Vaccination group, serum samples were collected 4 weeks after the Month 1 vaccination. Titers of anti-pertussis toxin (PT), anti-filamentous hemagglutinin (FHA), anti-pertactin (PRN), and anti-fimbriae 2/3 (FM 2/3) antibodies were measured using enzyme-linked immunosorbent assays. Titers are expressed as enzyme-linked immunoassay units/mL (ELU/mL).|4 weeks following Day 1 (Concomitant) or Month 1 (Non-concomitant) vaccination|The per-protocol population included participants who received vaccination and had serum samples available for evaluation of the endpoint||ELU/mL||95% Confidence Interval|Geometric Mean
812676|NCT01073293|Primary|Percentage of Participants Who Achieve Acceptable Titers of Anti-Diphtheria and Anti-Tetanus Antibody|For the Concomitant Vaccination group, serum samples were collected 4 weeks after the Day 1 vaccination; for the Non-concomitant Vaccination group, serum samples were collected 4 weeks after the Month 1 vaccination. Titers of neutralizing antibody to diphtheria toxin were measured using a cell-based Diphtheria Micrometabolic Inhibition assay. Serum titers of neutralizing antibody to tetanus toxin were measured using an enzyme immunoassay. The lower limits of quantitation of the assays was 0.01 International Units (IU)/mL and 0.04 IU/mL, respectively. Acceptable titers refer to the World Health Organization-defined protective titer of >=0.1 IU/mL.|4 weeks following Day 1 (Concomitant) or Month 1 (Non-concomitant) vaccination|The per-protocol population included participants who received vaccination and had serum samples available for evaluation of the endpoint||Percentage of participants||95% Confidence Interval|Number
812677|NCT01073293|Primary|Percentage of Participants With a Systemic Adverse Experience|For the Concomitant Vaccination group, systemic AEs were collected after the Day 1 vaccination and the Month 1 visit; for the Non-concomitant Vaccination group, systemic AEs were collected after the Day 1 vaccination and the Month 1 vaccination. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body that is temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the vaccine is also an adverse experience. A systemic AE was an AE that was not associated with the injection site.|Up to 15 days following the Day 1 and Month 1 vaccination / visit|The population analyzed included all vaccinated participants with follow-up||Percentage of participants|||Number
812678|NCT01073293|Primary|Percentage of Participants With Maximum Temperature >=37.8 °C (>=100.0 °F) (Oral or Oral Equivalent)|For the Concomitant Vaccination group, temperatures were collected after the Day 1 vaccination and the Month 1 visit; for the Non-concomitant Vaccination group, temperatures were collected after the Day 1 vaccination and the Month 1 vaccination.|Up to 5 days following the Day 1 and Month 1 vaccination / visit|The population analyzed included all vaccinated participants with follow-up||Percentage of participants|||Number
812709|NCT01073605|Primary|Change From Baseline in Annual Growth Rate Measured at 2 Years Following Treatment With Genotonorm|Annual growth rate was expressed as height velocity (centimeter [cm]/year). This was derived by substracting annual growth rate at Baseline from 2-year value. (Annual growth rate was calculated each year and rescaled to 1 year if the interval between x and x-1 was not 365 days, as long as a subject remains in the study): ANGRYx = (Height Yx – Height Y{x-1}) / {(Date of Yx – Date of Y{x-1}) /365.25}|Baseline, 2 years|All subjects who received at least 1 study dose of Genotonorm were included in the Full Analysis Set (FAS). Number of Participants Analyzed = number of subjects with change in annual growth rate at 2 years.||cm/year||Standard Deviation|Mean
812679|NCT01073293|Primary|Percentage of Participants With a Repevax™ Injection-site Adverse Experience|For the Concomitant Vaccination group, injection-site AEs are reported following Day 1 vaccination; for the Non-concomitant Vaccination group, injection-site AEs are reported following Month 1 vaccination. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the vaccine is also an AE. Only injection-site AEs in the arm that received Repevax™ vaccination were reported for this endpoint.|Day 1 through Day 5 following Day 1 (Concomitant) or Month 1 (Non-concomitant) vaccination|The population analyzed included all vaccinated participants with follow-up||Percentage of participants|||Number
812680|NCT01073293|Primary|Percentage of Participants With a V503 Injection-site Adverse Experience|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the vaccine is also an AE. Only injection-site AEs in the arm that received V503 vaccination were reported for this endpoint.|Day 1 through Day 5 following Day 1 vaccination|The population analyzed included all vaccinated participants with follow-up||Percentage of participants|||Number
812681|NCT01073293|Primary|Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503|Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 were measured using a competitive Luminex immunoassay. Titers are reported in milli Merck Units/mL.|4 weeks following Month 6 vaccination|The per-protocol population included participants who received all study vaccinations, were seronegative to HPV on Day 1, and had serum samples available for evaluation of the endpoint||milli Merck Units/mL||Full Range|Geometric Mean
812682|NCT01073449|Secondary|Number of Patients - Amongst Those Implanted With an Implantable Cardioverter Defibrillator (ICD)- in Whom Something (Therapy, Device Programming ...) Has Been Changed During In-hospital Follow-up||4 months|693 represents the number of patients implanted with an ICD within the whole population||Participants||95% Confidence Interval|Number
812683|NCT01073449|Primary|Number of Patients of the Whole Population in Whom Something (Therapy, Device Programming ...) Has Been Changed During In-hospital Follow-up||4 months|||Participants||95% Confidence Interval|Number
812684|NCT01073449|Secondary|Number of Patients -Amongst Those Implanted With a Pacemaker - in Whom Something (Therapy, Device Programming ...) Has Been Changed During In-hospital Follow-up||4 months|2246 represents the number of patients in the whole population that were implanted with a PM||Participants||95% Confidence Interval|Number
812685|NCT01073462|Secondary|Number of Participants With Cardiac Disease Progression|Cardiac disease progression was determined by the Investigator.|Month 3, 6, 12, 18, and 24|Intent-to-treat||participants|||Number
812686|NCT01073462|Secondary|Percentage of Participants Experiencing Hospitalization|The percentage of participants with at least one hospitalization, at least one cardiac-related hospitalization and at least one non-cardiac-related hospitalization during the course of the study.|24 months|Intent-to-treat||percentage of participants|||Number
812687|NCT01073462|Secondary|Percentage of Participants With at Least One Concomitant Medication|"The percentage of participants with at least one concomitant medication during the course of the study, by the following types:
Phosphate binder
Epoetin
Renin-Angiotensin-Aldosterone System (RAAS) inhibitors
Cinacalcet
Other"|24 months|Intent-to-treat||percentage of participants|||Number
812688|NCT01073462|Secondary|Percentage of Participants With at Least 30%-Reduction in iPTH Levels in at Least Two Consecutive Measurements|The percentage of participants with at least a 30% reduction in intact parathyroid hormone (iPTH) level from Baseline in at least 2 consecutive visits.|Baseline to Month 24|Intent-to-treat||percentage of participants|||Number
812689|NCT01073462|Secondary|Percentage of Participants With at Least a 30%-Reduction in iPTH Levels|The percentage of participants with at least a 30% reduction in intact parathyroid hormone (iPTH) levels from Baseline level.|Baseline and Months 3, 6, 12, 18, and 24|Intent-to-treat; LOCF was used.||percentage of participants|||Number
812690|NCT01073462|Secondary|Percentage of Participants With Hyperphosphatemia|Hyperphosphatemia was defined as a phosphate value of > 2.1 mmol/L (6.5 mg/dL) in one measurement. Serum phosphate was measured at every study visit.|Baseline and Months 3, 6, 12, 18, and 24|"Intent-to-treat; LOCF was used. n indicates the number of participants with available data at each time point."||percentage of participants|||Number
812691|NCT01073462|Secondary|Percentage of Participants With Hypercalcemia|Hypercalcemia was defined as a calcium value of > 2.625 mmol/L (10.5 mg/dL) in one measurement. Serum calcium was measured at every study visit.|Baseline and Months 3, 6, 12, 18, and 24|Intent-to-treat; LOCF was used||percentage of participants|||Number
812692|NCT01073462|Primary|Percentage of Participants Achieving an Intact Parathyroid Hormone (iPTH) Level Within the Target Range|Target range of intact parathyroid hormone was defined according to the Kidney Disease Outcomes Quality Initiative (K/DOQI) treatment guidelines as between 15.9 – 31.8 pmol/L (150 to 300 pg/mL).|Baseline and Months 3, 6, 12, 18, and 24|Intent-to-treat population; last observation carried forward (LOCF) imputation was used.||percentage of participants|||Number
812693|NCT01073566|Secondary|Self-reported Hypoglycemic Episodes|Severe hypoglycemia is defined as episodes in which the patient experienced coma, seizure, or suspected seizure or impairment sufficient to require the assistance of another person and either the blood glucose level is measured and found to be <50 mg/dl or the clinical manifestations were reversed by oral carbohydrate, subcutaneous glucagon, or intravenous glucose.|6 weeks|Intent to treat||episodes|||Number
812694|NCT01073566|Secondary|Insulin Delivery System Rating|Subject satisfaction with insulin delivery was assessed by self-report on the validated Insulin Delivery System Rating Questionnaire. Scale is 0-100. Higher score is better.|6 weeks|Per Protocol||units on a scale||Standard Deviation|Mean
812695|NCT01073566|Secondary|Glucose Profiles Per Day|Standard deviation of 7 daily blood glucose values (3 pre-meal, 3 post-meal, and bedtime) for 3 days|6 weeks|Intent to Treat||mmol/L||Standard Error|Least Squares Mean
812696|NCT01073566|Primary|Mean Daily Blood Glucose|Equivalence of Finesse to Usual Injection Device in Mean Daily Blood Glucose|6 weeks|Intent to treat||mmol/L||Standard Error|Least Squares Mean
812876|NCT01074554|Primary|Granuloma Burden|Number of patients with a decrease in Granuloma Burden (only in those patients having granulomas present at baseline biopsy)|Baseline to 8 weeks|||participants|||Number
812697|NCT01073605|Secondary|Number of Subjects Reaching Puberty|The defined criteria for reaching puberty were: boy=if right or left testes volume ≥4 ml; girl=if breast development ≥2. Tanner Adolescent Pubertal Staging Questionnaire documents the stage of development of secondary sexual characteristics rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size). Onset of puberty was defined as the visit where the data recorded first met the above criteria for starting puberty.|Baseline, 1 to 6 years|Safety population. Number of Participants Analyzed = number of subjects with evaluable data at Baseline. Data beyond 6 years are not reported due to the low proportion of subjects followed up beyond 6 years. Started = started puberty; Not Started = not started puberty yet as per Tanner scale.||participants|||Number
812698|NCT01073605|Secondary|Chronological Age at Onset of Puberty|Chronological age (years) at first study visit with onset of puberty = (Date of study visit minus Date of Birth) divided by 365.25.|Onset of puberty|Safety population. Number of participants analyzed = number of subjects who started puberty by the end of the study.||Years||Standard Deviation|Mean
812699|NCT01073605|Secondary|Change From Baseline in Bone Age/Change From Baseline in Chronological Age Ratio|Bone age was determined by the Greulich-Pyle method. Chronological Age (years) was calculated as: (Date minus Date of Birth) divided by 365.25. Chronological Age used was the age at the date that the corresponding Bone Age X-ray was performed. Ratio was calculated by change from Baseline in bone age divided by change from Baseline in chronological age.|1 to 3 years|Safety population = all subjects who received at least 1 study dose of GH. Number of Participants Analyzed = number of subjects with evaluable data at 1 year. n = number of subjects with evaluable data at each time point.||ratio||Standard Deviation|Mean
812700|NCT01073605|Secondary|Change From Baseline in Bone Age|Bone age was determined by the Greulich-Pyle method. Calculated by substracting bone age at Baseline from bone age at each year|Baseline, 1 to 3 years|Safety population = all subjects who received at least 1 study dose of GH. Number of Participants Analyzed = number of subjects with evaluable data at Baseline. n = number of subjects with evaluable data at Baseline and each time point.||Years||Standard Deviation|Mean
812701|NCT01073605|Secondary|Weight||Baseline, 1 to 6 years|FAS. Number of Participants Analyzed = number of subjects with evaluable data at Baseline. n = number of subjects with evaluable data at each time point. Data beyond 6 years are not reported due to the low proportion of subjects followed up beyond 6 years.||kg||Standard Deviation|Mean
812702|NCT01073605|Secondary|Body Mass Index (BMI)|BMI was calculated by weight divided by height squared.|Baseline, 1 to 6 years|FAS. Number of Participants Analyzed = number of subjects with evaluable data at Baseline. n = number of subjects with evaluable data at each time point. Data beyond 6 years are not reported due to the low proportion of subjects followed up beyond 6 years.||kg/m^2||Standard Deviation|Mean
812703|NCT01073605|Secondary|Change From Baseline in Height (SDS)|Calculated by substracting height SDS at Baseline from height SDS at each year. Final Height: Children are defined as reaching their final height when annual Growth Rate is less than 2 cm in the previous year and bone age is equal to or greater than 17 years in boys and equal to or greater than 15 years in girls.|Baseline, 1 to 6 years, final height|FAS. Number of Participants Analyzed = number of subjects with evaluable data at Baseline. n = number of subjects with evaluable data at Baseline and each time point. Data beyond 6 years are not reported due to the low proportion of subjects followed up beyond 6 years.||SDS||Standard Deviation|Mean
812704|NCT01073605|Secondary|Height (SDS)|Calculated using Sempe reference means and standard deviations for height. Final Height: Children are defined as reaching their final height when annual Growth Rate is less than 2 cm in the previous year and bone age is equal to or greater than 17 years in boys and equal to or greater than 15 years in girls.|Baseline, 1 to 6 years, final height|FAS. Number of Participants Analyzed = number of subjects with evaluable data at Baseline. n = number of subjects with evaluable data at each time point. Data beyond 6 years are not reported due to the low proportion of subjects followed up beyond 6 years.||SDS||Standard Deviation|Mean
812705|NCT01073605|Secondary|Change From Baseline in Height (cm)|Calculated by substracting height at Baseline from height at each year. Final Height: Children are defined as reaching their final height when annual Growth Rate is less than 2 cm in the previous year and bone age is equal to or greater than 17 years in boys and equal to or greater than 15 years in girls.|Baseline, 1 to 6 years, final height|FAS. Number of Participants Analyzed = number of subjects with evaluable data at Baseline. n = number of subjects with evaluable data at Baseline and each time point. Data beyond 6 years are not reported due to the low proportion of subjects followed up beyond 6 years.||cm||Standard Deviation|Mean
812706|NCT01073605|Secondary|Height (cm)|Performed by use of a wallmounted device (eg, Harpenden Stadiometer). Each subject was measured 3 times and the mean of these measurements was recorded as the present height. Final Height: Children are defined as reaching their final height when annual Growth Rate is less than 2 cm in the previous year and bone age is equal to or greater than 17 years in boys and equal to or greater than 15 years in girls.|Baseline, 1 to 6 years, final height|FAS. Number of Participants Analyzed = number of subjects with evaluable data at Baseline. n = number of subjects with evaluable data at each time point. Data beyond 6 years are not reported due to the low proportion of subjects followed up beyond 6 years.||cm||Standard Deviation|Mean
812707|NCT01073605|Secondary|Change From Baseline in Annual Growth Rate SDS|Calculated corresponding to the gender and chronological age by substracting annual growth rate SDS at Baseline from annual growth rate SDS at each year.|Baseline, 1 to 3 years|FAS. Number of Participants Analyzed = number of subjects with evaluable data at 1 year. n = number of subjects with evaluable data at each time point.||SDS||Standard Deviation|Mean
812708|NCT01073605|Secondary|Annual Growth Rate Standard Deviation Score (SDS)|Calculated using Sempe reference means and standard deviations for growth rate according to age and sex. Standardization was performed for chronological age.|Baseline, 1 to 6 years|FAS. Number of Participants Analyzed = number of subjects with evaluable data at Baseline. n = number of subjects with evaluable data at each time point. Data beyond 6 years are not reported due to the low proportion of subjects followed up beyond 6 years.||SDS||Standard Deviation|Mean
812722|NCT01073930|Secondary|Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Please Describe Your Overall Experience With the Study Preparation|Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 5-point scale: Excellent, Good, Fair, Poor, Bad|Day 2|Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Four participants either did not complete the questionnaire or did not answer this question.||percentage of participants|||Number
812710|NCT01073618|Secondary|Percentage of Participants With Cultivated Strain Mycological Response: Eradication, Persistence, Superinfection, or Not Evaluable|In case cultivation performed, cultivated strain before and after Vfend administration recorded, and the improvement of mycological outcomes after administration evaluated. Mycological response defined as: Eradication=absence of signs and symptoms of fungal infection; Persistence=(no eradication) presence of fungal infection; Superinfection=existence of different strains from strains separated prior to study medication; Not evaluable=a follow-up mycological cultivation is not performed.|Baseline (Day 1) up to 2 years|ITT; N=number of subjects evaluated for mycological response.||percentage of participants|||Number
812711|NCT01073618|Primary|Percentage of Participants With Categorical Clinical Response: Cure, Improvement, Failure, or Unevaluable|Clinical response defined as: Cure=resolution of all baseline signs and symptoms of fungal infection(s); Improvement=lessening of baseline signs and symptoms or absence of one or more, but not all baseline findings; Failure=no improvement or deterioration of baseline condition; Unevaluable=incomplete therapy (efficacy could not be evaluated or discontinuation was not followed up).|Baseline (Day 1) up to 2 years|Safety population: participants received at least 1 dose of study drug for the approved indication (=Intent to treat [ITT] population plus all unevaluable participants); ITT=participants received study drug for the approved indication and had been evaluated for related parameters at least once.||percentage of participants|||Number
812712|NCT01073631|Secondary|Percentage of Participants With Cultivated Strain Mycological Response: Eradication, Persistence, Superinfection, or Not Evaluable|In case cultivation performed, cultivated strain before and after Vfend administration recorded, and the improvement of mycological outcomes after administration evaluated. Mycological response defined as: Eradication=absence of signs and symptoms of fungal infection; Persistence=(no eradication) presence of fungal infection; Superinfection=existence of different strains from strains separated prior to study treatment; Not evaluable=a follow-up mycological cultivation not performed.|Baseline (Day 1) up to 2.1 Years|ITT; N=number of participants evaluated for mycological response.||Percentage of participants|||Number
812713|NCT01073631|Primary|Percentage of Participants With Categorical Clinical Response: Cure, Improvement, Failure, or Unevaluable|Clinical response defined as: Cure=resolution of all baseline signs and symptoms of fungal infection(s); Improvement=lessening of baseline signs and symptoms or absence of one or more, but not all baseline findings; Failure=no improvement or deterioration of baseline condition; Unevaluable=incomplete therapy (efficacy could not be evaluated or discontinuation was not followed up).|Baseline (Day 1) up to 2.1 Years|Safety population: participants received at least 1 dose of study drug for approved indication (= Intent to treat [ITT] population plus all unevaluable participants); ITT=participants received study drug for the approved indication and had been evaluated for related paramenters at least once.||Percentage of participants|||Number
812714|NCT01073657|Primary|"Supported Education Process Measure"|"Number of quarter hours spent in activities related to acquiring an education goal e.g., preparing applications, attending classes. Hours will be logged on a tally sheet adapted from the Supported Education Process Measure (Corrigan, 2009)."|6 months|Comparison of means||number of quarter hours||Standard Deviation|Mean
812715|NCT01073865|Secondary|Oestradiol (E2) Serum Concentrations at 24 Weeks|E2 serum concentrations (pg/mL) at 24 weeks|24 weeks after the first dosing|Full Analysis Set||pg/mL||Standard Deviation|Mean
812716|NCT01073865|Secondary|Number of Responders at 24 Weeks|Responders are defined as those patients with a best objective tumour response of CR or PR during the first 24 weeks of therapy. Tumour response is assessed according to the RECIST version 1.1. ORR is defined as the proportion of patients who are responders.|24 weeks after the first dosing|Full Analysis Set||Patients|||Number
812717|NCT01073865|Primary|Number of Patients With Progression-free Survival (PFS) at 24 Weeks|A patient is judged as progression-free survive at Week 24 if their PFS time is at least 24 weeks with no progression event prior to Week 24 (ie, overall visit response is complete response (CR), partial response (PR) or stable disease (SD) at a tumour assessment at least 24 weeks after randomization). Overall visit response is assessed according to the RECIST version 1.1. %PFS is the proportion of patients with PFS.|24 weeks after the first dosing|Full Analysis Set||Participants|||Number
812718|NCT01073930|Secondary|Participants With Treatment-Emergent Adverse Events (TEAEs)|Counts of participants who had TEAEs are summarized in a variety of categories. Severity and relatedness to study drug are in the opinion of the investigator. Severity is rated on a 3-point scale: mild (awareness of signs or symptoms, but no disruption of usual activity), moderate (event sufficient to affect usual activity), and severe (inability to work or perform usual activities). Only severe TEAEs are summarized. Relatedness is assessed on a 4-point scale: unrelated, unlikely, possibly and probably. Both possibly and probably answers are reported as 'related' to study medication.|up to one month|Safety population of participants who were treated.||participants|||Number
812719|NCT01073930|Secondary|Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Would You Refuse the Same Preparation Again if it Were to be Prescribed to You in the Future?|Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 2-point scale: yes, no|Day 2|Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Four participants either did not complete the questionnaire or did not answer this question.||percentage of participants|||Number
812720|NCT01073930|Secondary|Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Would You Ask Your Doctor for This Preparation Again if You Need Another Colonoscopy in the Future?|Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 2-point scale: yes, no|Day 2|Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Three participants either did not complete the questionnaire or did not answer this question.||percentage of participants|||Number
812721|NCT01073930|Secondary|Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: The Taste of This Study Preparation Was|Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 5-point scale: Excellent, Good, Tolerable, Poor, Bad|Day 2|Intent-to-treat population of randomized and treated participants with efficacy assessments performed. One participant either did not complete the questionnaire or did not answer this question.||percentage of participants|||Number
812877|NCT01074554|Primary|Change in Lesion Size at the Completion of Antibiotic Therapy, Measured on a Continuous Scale; Change Will be Determined by Change in Diameter of the Lesions||Baseline to 8 weeks|||mm||Standard Deviation|Median
812725|NCT01073930|Secondary|Percentage of Participants Classified as Successes (Excellent, Good and Fair Ratings) According to the Ottawa Scale As Assessed by a Blinded Gastroenterologist|Overall colon cleansing was assessed by a blinded gastroenterologist during the colonoscopy using the Ottawa scale, a 5-step rating scale: inadequate, poor, fair, good, and excellent. Excellent is defined as mucosal detail clearly visible; if fluid is present, it is clear and there is almost no stool residue. Good - some turbid fluid or stool residue but mucosal detail still visible; washing and suctioning is not necessary. Fair - turbid fluid or stool residue obscuring mucosal detail. However, mucosal detail becomes visible with suctioning and washing is not necessary.|Day 2|Intent-to-treat population of randomized and treated participants with efficacy assessments performed.||percentage of participants|||Number
812726|NCT01073930|Primary|Percentage of Participants Classified as Successes (Excellent and Good Ratings) According to the Aronchick Scale As Assessed by a Blinded Gastroenterologist|Overall colon cleansing was assessed by a blinded gastroenterologist during the colonoscopy using the Aronchick scale. The Aronchick scale is a 4-step rating scale: inadequate, fair, good, and excellent. Excellent is defined as >90% of mucosa seen, mostly liquid stool, minimal suctioning needed for adequate visualization. Good is defined as >90% of mucosa seen, mostly liquid stool, significant suctioning needed for adequate visualization.|Day 2|Intent-to-treat population of randomized and treated participants with efficacy assessments performed.||percentage of participants|||Number
812727|NCT01073943|Other Pre-specified|Percentage of Participants Classified as Successes (Excellent, Good and Fair Ratings) For Colon Cleansing According to the Ottawa Scale As Assessed by a Blinded Gastroenterologist|Colon cleansing was assessed by a blinded gastroenterologist during the colonoscopy using the Ottawa scale, a 5-step rating scale: inadequate, poor, fair, good, and excellent. See Outcome #2 for definitions of the scale. Assessment of mid colon, recto-sigmoid, and overall (ascending, mid, and recto-sigmoid) cleansing is summarized here.|Day 2|Intent-to-treat population of randomized and treated participants with efficacy assessments performed.||percentage of participants|||Number
812728|NCT01073943|Secondary|Participants With Treatment-Emergent Adverse Events (TEAEs)|Counts of participants who had TEAEs are summarized in a variety of categories. Severity and relatedness to study drug are in the opinion of the investigator. Severity is rated on a 3-point scale: mild (awareness of signs or symptoms, but no disruption of usual activity), moderate (event sufficient to affect usual activity), and severe (inability to work or perform usual activities). Only severe TEAEs are summarized. Relatedness is assessed on a 4-point scale: unrelated, unlikely, possibly and probably. Both possibly and probably answers are reported as 'related' to study medication.|up to one month|Safety population of participants who were treated.||participants|||Number
812729|NCT01073943|Secondary|Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Would You Refuse the Same Preparation Again if it Were to be Prescribed to You in the Future?|Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 2-point scale: yes, no|Day 2|Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Three participants either did not complete the questionnaire or did not answer this question.||percentage of participants|||Number
812730|NCT01073943|Secondary|Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Would You Ask Your Doctor for This Preparation Again if You Need Another Colonoscopy in the Future?|Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 2-point scale: yes, no|Day 2|Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Three participants either did not complete the questionnaire or did not answer this question.||percentage of participants|||Number
812731|NCT01073943|Secondary|Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: The Taste of This Study Preparation Was|Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 5-point scale: Excellent, Good, Tolerable, Poor, Bad|Day 2|Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Three participants either did not complete the questionnaire or did not answer this question.||percentage of participants|||Number
812732|NCT01073943|Secondary|Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Please Describe Your Overall Experience With the Study Preparation|Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 5-point scale: Excellent, Good, Fair, Poor, Bad|Day 2|Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Four participants either did not complete the questionnaire or did not answer this question.||percentage of participants|||Number
812733|NCT01073943|Secondary|Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Were You Able to Consume the Entire Prep As Instructed?|Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 2-point scale: yes, no|Day 2|Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Three participants either did not complete the questionnaire or did not answer this question.||percentage of participants|||Number
812734|NCT01073943|Secondary|Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: How Easy or Difficult Was It To Consume the Study Drug?|Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 5-point scale: very easy, easy, tolerable, difficult, very difficult|Day 2|Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Three participants either did not complete the questionnaire or did not answer this question.||percentage of participants|||Number
812735|NCT01073943|Secondary|Percentage of Participants Classified as Successes (Excellent, Good and Fair Ratings) For Ascending Colon Cleansing According to the Ottawa Scale As Assessed by a Blinded Gastroenterologist|Cleansing of the ascending colon was assessed by a blinded gastroenterologist during the colonoscopy using the Ottawa scale, a 5-step rating scale: inadequate, poor, fair, good, and excellent. Excellent is defined as mucosal detail clearly visible; if fluid is present, it is clear and there is almost no stool residue. Good - some turbid fluid or stool residue but mucosal detail still visible; washing and suctioning is not necessary. Fair - turbid fluid or stool residue obscuring mucosal detail. However, mucosal detail becomes visible with suctioning and washing is not necessary.|Day 2|Intent-to-treat population of randomized and treated participants with efficacy assessments performed.||percentage of participants|||Number
812737|NCT01074008|Other Pre-specified|Change From Baseline in SF-36 Mental Component Summary (MCS)|The Mental Component Summary (MCS) of the SF-36 was used to measure the overall mental health status of participants. The aggregated score of the SF-36 MPS was standardized using a linear T-score transformation with a mean of 50 and a standard deviation of 10; a higher score indicated better mental function and well-being. Data presented are the summaries across all participants, for each treatment arm, regardless of dose. Data are presented as the group mean change from baseline ± standard deviation.|Baseline and Post-treatment Week 24|Participants received at least one dose of study drug (direct-acting antiviral agent) and have both baseline and at least one post-baseline measurement of HCV RNA levels during monotherapy treatment.||units on a scale||Standard Deviation|Mean
812738|NCT01074008|Other Pre-specified|Change From Baseline in SF-36 Physical Component Summary (PCS)|The Physical Component Summary (PCS) of the SF-36 was used to measure the overall physical health status of a participant. The aggregated score of the SF-36 PCS score was standardized using a linear T-score transformation with a mean of 50 and a standard deviation of 10; a higher score indicated better physical function and well-being. Data presented are the summaries across all participants, for each treatment arm, regardless of dose. Data are presented as the group mean change from baseline ± standard deviation.|Baseline and Post-treatment Week 24|Participants received at least one dose of study drug (direct-acting antiviral agent) and have both baseline and at least one post-baseline measurement of HCV RNA levels during monotherapy treatment.||units on a scale||Standard Deviation|Mean
812739|NCT01074008|Other Pre-specified|Change From Baseline in EQ-5D (3 Level) Health Index Score|The EQ-5D was a health state questionnaire used to measure five health dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). The combination of responses from all five dimensions were derived into an index score ranging from 0 to 1; a higher score indicated a more preferable health utility value from the societal perspectives. Data presented are the summaries across all participants, for each treatment arm, regardless of dose. Data are presented as the group mean change from baseline ± standard deviation.|Baseline and Post-treatment Week 24|Participants received at least one dose of study drug (direct-acting antiviral agent) and have both baseline and at least one post-baseline measurement of HCV RNA levels during monotherapy treatment.||units on a scale||Standard Deviation|Mean
812740|NCT01074008|Other Pre-specified|Change From Baseline in ED-5D Visual Analog Scale (ED-5D VAS) Score|The ED-5D VAS was a self-rating survey used to capture the current health status of a participant and ranged from 0 (the worst imaginable health state) to 100 (best imaginable health state). Data presented are the summaries across all participants, for each treatment arm, regardless of dose. Data are presented as the group mean change from baseline ± standard deviation.|Baseline and Post-treatment Week 24|Participants received at least one dose of study drug (direct-acting antiviral agent) and have both baseline and at least one post-baseline measurement of HCV RNA levels during monotherapy treatment.||units on a scale||Standard Deviation|Mean
812741|NCT01074008|Other Pre-specified|Change From Baseline in Hepatitis C Virus Patient-reported Outcomes (HCV-PRO) Total Score|The Hepatitis C Virus Patient-report Outcomes (HCV-PRO, formerly known as HCV Quality of Life) survey was used to assess disease-specific function and well-being on a scale from 0 to 100; a higher score indicated relatively good function and well-being of treated participants. Data presented are the summaries across all participants, for each treatment arm, regardless of dose. Data are reported as the group mean change from baseline ± standard deviation.|Baseline up to Post-treatment Week 24|Participants received at least one dose of study drug (direct-acting antiviral agent) and have both baseline and at least one post-baseline measurement of HCV RNA levels during monotherapy treatment.||units on a scale||Standard Deviation|Mean
812742|NCT01074008|Other Pre-specified|Number of Participants With Resistance-Associated Variants and Phenotypic Resistance to ABT-333 in Non-structural Viral Protein 5B (NS5B)|Baseline samples were analyzed for resistance-associated amino acid variants using population and clonal sequencing and were compared with the appropriate reference sequence (1a-H77 or 1b-Con1). Phenotypic resistance to ABT-333 at baseline was assessed by calculating the fold difference in the half maximal effective concentration (EC50) compared with the EC50 for the appropriate reference replicon (1a-H77 or 1b-Con1). Available samples at Day 4 with HCV RNA ≥ 1000 IU/mL were analyzed for the presence of resistance-associated variants using population and clonal sequencing and were compared with the baseline sequences to assess amino acid changes. Phenotypic resistance to ABT-333 at Day 4 was assessed by calculating the fold difference in the EC50 compared with the EC50 for the corresponding baseline sample. The number of participants with variants at resistance-associated amino acid positions and phenotypic resistance are presented.|Baseline and Day 4|All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the analysis. When the number of participants used to analyze the data at a specific time point differs from the Number of Participants Analyzed, the n (number of participants) is denoted in the Category Title.||participants|||Number
812743|NCT01074008|Other Pre-specified|Number of Participants With Resistance-Associated Variants and Phenotypic Resistance to ABT-072 in Non-structural Viral Protein 5B (NS5B)|Baseline samples were analyzed for resistance-associated amino acid variants using population and clonal sequencing and were compared with the appropriate reference sequence (1a-H77 or 1b-Con1). Phenotypic resistance to ABT-072 at baseline was assessed by calculating the fold difference in the half maximal effective concentration (EC50) compared with the EC50 for the appropriate reference replicon (1a-H77 or 1b-Con1). Available samples at Day 4 with HCV RNA ≥ 1000 IU/mL were analyzed for the presence of resistance-associated variants using population and clonal sequencing and were compared with the baseline sequences to assess amino acid changes. Phenotypic resistance to ABT-072 at Day 4 was assessed by calculating the fold difference in the EC50 compared with the EC50 for the corresponding baseline sample. The number of participants with variants at resistance-associated amino acid positions and phenotypic resistance are presented.|Baseline and Day 4|All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the analysis. When the number of participants used to analyze the data at a specific time point differs from the Number of Participants Analyzed, the n (number of participants) is denoted in the Category Title.||participants|||Number
812878|NCT01074658|Secondary|Percentage of Participants With Procedural Success|Procedural success, defined as device success with absence of in-hospital MACCE|up to 30 days|All attempted population in which the separate variables related to procedural success (see outcome measure description) were analyzable.||percentage of participants|||Number
812744|NCT01074008|Other Pre-specified|Number of Participants With Resistance-Associated Variants and Phenotypic Resistance to ABT-450 in Non-structural Viral Protein 3 (NS3)|Baseline samples were analyzed for resistance-associated amino acid variants using population and clonal sequencing and were compared with the appropriate reference sequence (1a-H77 or 1b-Con1). Phenotypic resistance to ABT-450 at baseline was assessed by calculating the fold difference in the half maximal effective concentration (EC50) compared with the EC50 for the appropriate reference replicon (1a-H77 or 1b-Con1). Available samples at Day 4 with HCV RNA ≥ 1000 IU/mL were analyzed for resistance-associated variants using population and clonal sequencing and were compared with the baseline sequences to assess amino acid changes. Phenotypic resistance to ABT-450 at Day 4 was assessed by calculating the fold difference in the EC50 compared with the EC50 for the corresponding baseline sample. The number of participants with variants at resistance-associated amino acid positions and phenotypic resistance are presented.|Baseline and Day 4|All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the analysis. When the number of participants used to analyze the data at a specific time point differs from the Number of Participants Analyzed, the n (number of participants) is denoted in the Category Title.||participants|||Number
812745|NCT01074008|Secondary|Percentage of Participants With Complete Early Virologic Response (cEVR) at Week 12|Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay that had a lower limit of detection of 10 IU/mL and a lower limit of quantification (LLOQ) of 25 IU/mL. Complete EVR was defined as HCV RNA levels < LLOQ (< 25 IU/mL) at Week 12. Data are reported as the percentage of participants with cEVR.|Week 12|To be included in the efficacy analysis, participants received at least one dose of study drug (direct-acting antiviral agent) and have at least one post-baseline measurement of HCV RNA levels.||percentage of participants|||Number
812746|NCT01074008|Primary|Area Under the Plasma Concentration-time Curve From 0 to 12 Hours (AUC12) Post-dose of ABT-333|Blood samples were collected immediately prior to morning dose (time 0 hours) and at 2, 4, 8, and 12 hours after the morning dose on Day 1. The samples were analyzed for the concentration of ABT-333 using validated analytical methods. The area under the plasma concentration-time curve (AUC; measured in ng*hr/mL) is a method of measurement to determine the total exposure of a drug in blood plasma. The AUC12 of ABT-333 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Immediately prior to morning dose (time 0 hours) and at 2, 4, 8, and 12 hours after the morning dose on Day 1|All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.||ng*hr/mL||Standard Deviation|Mean
812747|NCT01074008|Primary|Time to Maximum Plasma Concentration (Tmax) of ABT-333|Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-333 using validated analytical methods. The time to maximum plasma concentration (Tmax; measured in hours) is the time it takes for a drug to achieve Cmax. The Tmax of ABT-333 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)|All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.||Hours||Standard Deviation|Mean
812748|NCT01074008|Primary|Maximum Plasma Concentration (Cmax) of ABT-333|Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-333 using validated analytical methods. The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that a drug achieves in the blood after administration in a dosing interval. The Cmax of ABT-333 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)|All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.||ng/mL||Standard Deviation|Mean
812749|NCT01074008|Primary|Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24) Post-dose of ABT-072|Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-072 using validated analytical methods. The area under the plasma concentration-time curve (AUC; measured in ng*hr/mL) is a method of measurement to determine the total exposure of a drug in blood plasma. The AUC24 of ABT-072 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)|All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.||ng*hr/mL||Standard Deviation|Mean
812750|NCT01074008|Primary|Time to Maximum Plasma Concentration (Tmax) of ABT-072|Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-072 using validated analytical methods. The time to maximum plasma concentration (Tmax; measured in hours) is the time it takes for a drug to achieve Cmax. The Tmax of ABT-072 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)|All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.||Hours||Standard Deviation|Mean
812767|NCT01074047|Secondary|Healthcare Resource Utilization (HRU): Number of Inpatient Hospitalizations|HRU was defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient. HRU Analysis may help in evaluating potential costs and budget impact of new treatments from a payer perspective.|Day 1 (randomization) to 40 months|HRU was analyzed for the HRQoL Evaluable Population, a smaller sample than either the ITT population or safety population. Duration of therapy differed between treatment groups. Rate-per-patient year values adjust for these differences.||participants|||Number
812751|NCT01074008|Primary|Maximum Plasma Concentration (Cmax) of ABT-072|Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-072 using validated analytical methods. The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that a drug achieves in the blood after administration in a dosing interval. The Cmax of ABT-072 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)|All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.||ng/mL||Standard Deviation|Mean
812752|NCT01074008|Primary|Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24) Post-dose of Ritonavir|Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ritonavir using validated analytical methods. The area under the plasma concentration-time curve (AUC; measured in ng*hr/mL) is a method of measurement to determine the total exposure of a drug in blood plasma. The AUC24 of ritonavir was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)|All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.||ng*hr/mL||Standard Deviation|Mean
812753|NCT01074008|Primary|Time to Maximum Plasma Concentration (Tmax) of Ritonavir|Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ritonavir using validated analytical methods. The time to maximum plasma concentration (Tmax; measured in hours) is the time it takes for a drug to achieve Cmax. The Tmax of ritonavir was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)|All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.||Hours||Standard Deviation|Mean
812754|NCT01074008|Primary|Maximum Plasma Concentration (Cmax) of Ritonavir|Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ritonavir using validated analytical methods. The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that a drug achieves in the blood after administration in a dosing interval. The Cmax of ritonavir was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)|All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.||ng/mL||Standard Deviation|Mean
812755|NCT01074008|Primary|Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24) Post-dose of ABT-450|Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-450 using validated analytical methods. The area under the plasma concentration-time curve (AUC; measured in ng*hr/mL) is a method of measurement to determine the total exposure of a drug in blood plasma. The AUC24 of ABT-450 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)|All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.||ng*hr/mL||Standard Deviation|Mean
812756|NCT01074008|Primary|Time to Maximum Plasma Concentration (Tmax) of ABT-450|Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-450 using validated analytical methods. The time to maximum plasma concentration (Tmax; measured in hours) is the time it takes for a drug to achieve Cmax. The Tmax of ABT-450 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)|All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.||Hours||Standard Deviation|Mean
812757|NCT01074008|Primary|Maximum Plasma Concentration (Cmax) of ABT-450|Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-450 using validated analytical methods. The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that a drug achieves in the blood after administration in a dosing interval. The Cmax of ABT-450 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)|All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.||ng/mL||Standard Deviation|Mean
812825|NCT01074307|Secondary|Mean Change From Baseline in Global Assessment of Congestive Heart Failure (CHF) Score at Week 26|Global assessment of CHF: The Investigator defined, graded, and recorded the participant’s symptoms and signs by using a 6-point CHF scale ranging from 0 (unassessable), 1 (worsened), 2 (no change), 3 (mildly improved), 4 (moderately improved) and 5 (markedly improved).|Baseline and Week 26|ITT population included all the randomized participants who had at least one dose of the investigational product. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure. 'n' signifies number of participants who were evaluable for specified categories at different time points.||Units on a scale||Standard Deviation|Mean
812758|NCT01074008|Secondary|Percentage of Participants With Partial Early Virologic Response (EVR) at Week 12|Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay that had a lower limit of detection of 10 IU/mL and a lower limit of quantification of 25 IU/mL. Partial early virologic response (EVR) was defined as HCV RNA levels that decreased > 2 log10 IU/mL at Week 12 as compared to baseline. The baseline value was the last measurement before the first dose on Day 1. Data are reported as the percentage of participants with partial EVR.|Baseline and Week 12|To be included in the efficacy analysis, participants received at least one dose of study drug (direct-acting antiviral agent) and at least one post-baseline measurement of HCV RNA levels.||percentage of participants|||Number
812759|NCT01074008|Secondary|Percentage of Participants With Rapid Virologic Response (RVR) at Week 4|Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay that had a lower limit of detection of 10 IU/mL and a lower limit of quantification (LLOQ) of 25 IU/mL. Rapid virologic response was defined as HCV RNA level < LLOQ (< 25 IU/mL) at Week 4. Data are reported as the percentage of participants with RVR.|Week 4|All participants who received at least one dose of study drug and had at least one post-baseline HCV RNA value were included in this efficacy analysis.||percentage of participants|||Number
812760|NCT01074008|Primary|Maximal Change From Baseline in Hepatitis C Virus Ribonucleic Acid (HCV RNA) Levels During ABT-450/r, ABT-333, or ABT-072 Monotherapy Treatment|Plasma HCV RNA levels (reported as log10 IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay that had a lower limit of detection of 10 IU/mL and a lower limit of quantification of 25 IU/mL. The baseline value was the HCV RNA level before the first dose of study drug on Day 1. The maximal change during monotherapy was the difference from baseline to the lowest log10 HCV RNA level anytime after the first dose of study drug on Day 1 through the last log10 HCV RNA level before the first dose of study drug on Day 4. Data are reported as the mean ± standard deviation.|Prior to dosing on Day 1 to before the morning dose on Day 4|Participants received at least one dose of study drug (direct-acting antiviral agent) and have both baseline and at least one post-baseline measurement of HCV RNA levels during monotherapy treatment.||log10 IU/mL||Standard Deviation|Mean
812761|NCT01074034|Secondary|Conversion Success Rate up to Three Months Post-implant|For a pacemaker patient who experiences a spontaneous high rate ventricular arrhythmia, the ASSURE device may provide rescue shocks, a faster and more effective response than external methods of rescue. Successful conversion of an episode is defined by conversion to either; sinus rhythm, sinus tachycardia or atrial pacing by one minute post therapy delivery.|Three months post-implant|||% of conversion rates|||Number
812762|NCT01074034|Primary|Inappropriate Shock Free Rate|Incidences of ventricular shock therapy up to three months post implant. Rescue shocks are intended for the treatment of cardiac arrhythmias detected in the ventricle at rates greater than 220 bpm, including arrhythmias that originate in the atria if they are conducted at rates greater than 220 bpm as this can be life threatening if persistent. Shocks delivered for other reasons will be considered inappropriate shocks.|Three months post-implant|||% of shock free rates|||Number
812763|NCT01074047|Secondary|Number of Participants in the Extension Phase With Treatment Emergent Adverse Events (TEAEs)|AEs = any noxious, unintended, or untoward medical occurrence that may appear or worsen during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant’s health, regardless of cause. Serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs were graded based upon the participants symptoms according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0); AEs were evaluated for severity according to the following scale: Grade 1 = Mild – transient or mild discomfort; no medical intervention required; Grade 2 = Moderate – mild to moderate limitation in activity; Grade 3 = Severe; Grade 4 = Life threatening; Grade 5 = Death|From the date of informed consent for the Extension Phase through to the date of last dose of study drug + 28 days up to last visit completed 24 July 2016; maximum duration of exposure to Azacitidine was 871 days|Safety population includes those enrolled in the extension phase who received at least one dose of study drug.||participants|participants||Number
812764|NCT01074047|Secondary|HRU: Rate of Transfusions Per Patient Year|HRU is defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient. HRU Analysis may help in evaluating potential costs and budget impact of new treatments from a payer perspective. The rate of transfusions per patient year was calculated as the total number of transfusions divided by the total number of patient-years followed in the study period. Patient-years (PY) were calculated as the duration from baseline to last available HRQL assessment for each patient.|Day 1 (randomization) to 40 months|HRU was analyzed for the HRQoL Evaluable Population, a smaller sample than either the ITT population or safety population. Duration of therapy differed between treatment groups. Rate-per-patient year values adjust for these differences.||transfusions per patient year|||Number
812765|NCT01074047|Secondary|HRU: Number of Participants Receiving Transfusions|Count of study participants who had transfusions during the treatment phase. HRU is defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient. HRU Analysis may help in evaluating potential costs and budget impact of new treatments from a payer perspective.|Day 1 (randomization) to 40 months|HRU was analyzed for the HRQoL Evaluable Population, a smaller sample than either the ITT population or safety population. Duration of therapy differed between treatment groups. Rate-per-patient year values adjust for these differences.||participants|||Number
812766|NCT01074047|Secondary|Healthcare Resource Utilization (HRU): Rate of Inpatient Hospitalizations Per Year|HRU was defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient. HRU Analysis may help in evaluating potential costs and budget impact of new treatments from a payer perspective. The rate of inpatient hospitalizations per patient year was calculated as the total number of hospitalizations divided by the total number of patient-years followed in the study period. Patient-years (PY) were calculated as the duration from baseline to last available HRQL assessment for each patient.|Day 1 (randomization) to 40 months|HRU was analyzed for the HRQoL Evaluable Population, a smaller sample than either the ITT population or safety population. Duration of therapy differed between treatment groups. Rate-per-patient year values adjust for these differences.||hospitalizations per patient year|||Number
812768|NCT01074047|Secondary|HRQoL: Change From Baseline in the EORTC QLQ-C30 Global Health Status-/Quality of Life Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status/QOL scale is scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in Global Health Status/QOL and positive values indicate improvement.|Baseline to end of study, at approximately 11-12 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.||units on a scale||Standard Deviation|Mean
812769|NCT01074047|Secondary|HRQoL: Change From Baseline in the EORTC QLQ-C30 Global Health Status-/Quality of Life Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status/QOL scale is scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in Global Health Status/QOL and positive values indicate improvement.|Baseline to Cycle 9, at approximately 9 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.||units on a scale||Standard Deviation|Mean
812770|NCT01074047|Secondary|HRQoL: Change From Baseline in the EORTC QLQ-C30 Global Health Status-/Quality of Life Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status/QOL scale is scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in Global Health Status/QOL and positive values indicate improvement.|Baseline to Cycle 7, at approximately 7 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.||units on a scale||Standard Deviation|Mean
812771|NCT01074047|Secondary|HRQoL: Change From Baseline in the EORTC QLQ-C30 Global Health Status-/Quality of Life Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status/QOL scale is scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in Global Health Status/QOL and positive values indicate improvement.|Baseline to Cycle 5, at approximately 5 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.||units on a scale||Standard Deviation|Mean
812772|NCT01074047|Secondary|HRQoL: Change From Baseline in the EORTC QLQ-C30 Global Health Status-/Quality of Life Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status/QOL scale is scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in Global Health Status/QOL and positive values indicate improvement.|Baseline to Cycle 3, at approximately 3 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.||units on a scale||Standard Deviation|Mean
812773|NCT01074047|Secondary|HRQoL: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 PhysicalFunctioning Scale is scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.|Baseline to end of study, at approximately 11-12 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.||units on a scale||Standard Deviation|Mean
812826|NCT01074307|Secondary|Number of Participants With Adverse Events (AEs)|An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.|Baseline up to Week 26|Safety analysis population included all the randomized participants who had at least one dose of the investigational product had post-dose safety data confirmed at least once by the Investigator.||Participants|||Number
812774|NCT01074047|Secondary|HRQoL: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 PhysicalFunctioning Scale is scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.|Baseline to Cycle 9, at approximately 9 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.||units on a scale||Standard Deviation|Mean
812775|NCT01074047|Secondary|HRQoL: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 PhysicalFunctioning Scale is scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.|Baseline to Cycle 7, at approximately 7 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.||units on a scale||Standard Deviation|Mean
812776|NCT01074047|Secondary|HRQoL: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 PhysicalFunctioning Scale is scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.|Baseline to Cycle 5, at approximately 5 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.||units on a scale||Standard Deviation|Mean
812777|NCT01074047|Secondary|HRQoL: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 PhysicalFunctioning Scale is scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.|Baseline to Cycle 3, at approximately 3 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.||units on a scale||Standard Deviation|Mean
812778|NCT01074047|Secondary|HRQoL: Change From Baseline in the EORTC QLQ-C30 Dyspnea|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Dyspnea scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate decreased dyspnea (i.e. improvement in symptom) and positive values indicate increased dyspnea (i.e. worsening of symptom).|Baseline to end of study, at approximately 11-12 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.||units on a scale||Standard Deviation|Mean
812779|NCT01074047|Secondary|HRQoL: Change From Baseline in the EORTC QLQ-C30 Dyspnea|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Dyspnea scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate decreased dyspnea (i.e. improvement in symptom) and positive values indicate increased dyspnea (i.e. worsening of symptom).|Baseline to Cycle 9, at approximately 9 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population. The analysis included 157 from the azacitidine group and 134 in the CCR group, a smaller number than the ITT population.||units on a scale||Standard Deviation|Mean
812827|NCT01074307|Secondary|Number of Participants Who Were Re-hospitalized Due to Heart Failure and Who Died Due to Cardiovascular Disorder||Baseline up to Week 26|ITT population included all the randomized participants who had at least one dose of the investigational product.||Participants|||Number
813006|NCT01075815|Secondary|Total Number of Births|Total number of births per reporting group was calculated.|Up to 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days])|"ITT population included all randomized participants who had received at least 1 dose of the study medication. Here N represents number of participants evaluated for this measure."||births|||Number
812780|NCT01074047|Secondary|HRQoL: Change From Baseline in the EORTC QLQ-C30 Dyspnea|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Dyspnea scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate decreased dyspnea (i.e. improvement in symptom) and positive values indicate increased dyspnea (i.e. worsening of symptom).|Baseline to Cycle 7, at approximately 7 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.||units on a scale||Standard Deviation|Mean
812781|NCT01074047|Secondary|HRQoL: Change From Baseline in the EORTC QLQ-C30 Dyspnea|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Dyspnea scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate decreased dyspnea (i.e. improvement in symptom) and positive values indicate increased dyspnea (i.e. worsening of symptom).|Baseline to Cycle 5, at approximately 5 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.||units on a scale||Standard Deviation|Mean
812782|NCT01074047|Secondary|HRQoL: Change From Baseline in the EORTC QLQ-C30 Dyspnea|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Dyspnea scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate decreased dyspnea (i.e. improvement in symptom) and positive values indicate increased dyspnea (i.e. worsening of symptom).|Baseline to Cycle 3, at approximately 3 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.||units on a scale||Standard Deviation|Mean
812783|NCT01074047|Secondary|Health Related Quality of Life (HRQoL): Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reduction in fatigue (i.e. improvement in symptom) and positive values indicate increases in fatigue (i.e. worsening of symptom).|Baseline to End of Study; at approximately 11-12 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.||units on a scale||Standard Deviation|Mean
812784|NCT01074047|Secondary|Health Related Quality of Life (HRQoL): Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reduction in fatigue (i.e. improvement in symptom) and positive values indicate increases in fatigue (i.e. worsening of symptom).|Baseline to Cycle 9, at approximately 9 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population. .||units on a scale||Standard Deviation|Mean
812785|NCT01074047|Secondary|Health Related Quality of Life (HRQoL): Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reduction in fatigue (i.e. improvement in symptom) and positive values indicate increases in fatigue (i.e. worsening of symptom).|Baseline to Cycle 7, at approximately 7 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.||units on a scale||Standard Deviation|Mean
812786|NCT01074047|Secondary|Health Related Quality of Life (HRQoL): Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reduction in fatigue (i.e. improvement in symptom) and positive values indicate increases in fatigue (i.e. worsening of symptom).|Baseline to Cycle 5, at approximately 5 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.||units on a scale||Standard Deviation|Mean
812787|NCT01074047|Secondary|Health Related Quality of Life (HRQoL): Change From Baseline in the European Organization for Research and Treatment of Cancer Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reduction in fatigue (i.e. improvement in symptom) and positive values indicate increases in fatigue (i.e. worsening of symptom).|Baseline to Cycle 3; at approximately 3 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.||units on a scale||Standard Deviation|Mean
812788|NCT01074047|Secondary|Number of Participants With Adverse Events (AEs)|AEs = any noxious, unintended, or untoward medical occurrence that may appear or worsen during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant’s health, regardless of cause. Serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs were graded based upon the participants symptoms according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0); AEs were evaluated for severity according to the following scale: Grade 1 = Mild – transient or mild discomfort; no medical intervention required; Grade 2 = Moderate – mild to moderate limitation in activity; Grade 3 = Severe; Grade 4 = Life threatening; Grade 5 = Death|Day 1 (randomization) up to last visit completed; final data cut off of 28 Feb 2017|Safety population = all randomized participants who received at least 1 dose of study drug and had 1 post-dose safety assessment. Because the BSC only regimen consisted of blood products or antibiotics given as needed, those assigned to BSC only were included in the safety population if they had at least 1 post-randomization safety assessment.||participants|||Number
812789|NCT01074047|Secondary|Number of Participants Who Achieved a Cytogenetic Complete Response (CRc-10) as Determined by the IRC.|The CRc is a normal karyotype defined as no clonal abnormalities after review of at least 10 metaphases using conventional cytogenetic techniques. Cytogenetic complete remission rate (CRc) is when the following criteria are met: 1) CR criteria met and 2) an abnormal karyotype is present at baseline and 3) there is reversion to normal karyotype at the time of CR (based on ≥ 10 metaphases), where date of cytogenetic sample = date of BM sample used for the CR assessment|Day 1 (randomization) to 40 months|The intent-to-treat (ITT) population was defined as all participants who were randomized, independent of whether they received study treatment or not. Includes participants who died and participants who were censored||participants|||Number
812790|NCT01074047|Secondary|Duration of Remission Assessed by the IRC Based on Kaplan-Meier Estimates|The time from the date CR or CRi was first documented until the date of documented relapse from CR/CRi. Duration of remission was defined only for those participants who achieved a CR or CRi, as determined by the IRC. Participants who were lost to follow-up without documented relapse, or were alive at last follow-up without documented relapse were censored at the date of their last response assessment.|Day 1 (randomization) to 40 months; date of the first documented CR or CRi until date of first documented relapse.|Includes those who achieved a CR or CRi and assessed by the IRC; numbers of ITT participants in each treatment group||months||95% Confidence Interval|Median
812791|NCT01074047|Secondary|Percentage of Participants Who Achieved a Morphologic CR + CRi as Determined by the Independent Review Committee (IRC) Based on International Working Group (IWG) Response Criteria for Acute Myeloid Leukemia (AML)|A complete remission (CR) is defined as a leukemia-free state defined as less than 5% blasts in a BM aspirate with marrow spicules and with at least 200 nucleated cells (there should be no blasts with Auer rods), an absolute neutrophil count (ANC) of ≥ 1 x 10^9/L, a platelet count ≥ 100 x 10^9/L, and transfusion independence (no transfusions for 1 week prior to each assessment). No duration of these findings is required for confirmation of this response. A CR with incomplete blood count recovery (CRi) is defined as <5% BM blasts with the ANC count < 1 x 10^9/L and/or the platelet count may be < 100 x 10^9/L. Where the date of the hematology assessment used is the earliest on or following the date of the BM sample up to 8 days after the BM date.|Day 1 (randomization) to 40 months|The intent-to-treat (ITT) population was defined as all participants who were randomized, independent of whether they received study treatment or not. Includes participants who died and participants who were censored||percentage of participants|||Number
812792|NCT01074047|Secondary|Relapse-Free Survival (RFS) for Participants Who Achieved a Complete Remission (CR) or Complete Remission With Incomplete Blood Count Recovery (CRi)|Relapse-free survival was defined as the interval from the date of first documented CR or CRi to the date of relapse, death from any cause, or lost to follow-up, whichever occurred first. Participants who were still alive and in continuous CR or CRi were censored at the date of their last response assessment.|Day 1 of first documented CR or CRi to the date of relapse, death from any cause, or lost to follow-up. Day 1 (randomization) to 40 months|Participants who achieved a CR or CRi||months||95% Confidence Interval|Median
812793|NCT01074047|Secondary|Event-free Survival (EFS)|Event-free survival was defined as the interval from the date of randomization to the date of treatment failure, progressive disease, relapse after complete remission (CR) or complete remission with incomplete blood count recovery (CRi), death from any cause, or lost to follow-up, whichever occurs first. Participants who were still alive without any of these events were censored at the date of their last response assessment.|Day 1 (randomization) to date of treatment failure, progressive disease, relapse after Complete Remission (CR) or Complete remission with incomplete blood count recovery (CRi), death from any cause. Day 1 (randomization) to 40 months|The intent-to-treat (ITT) population was defined as all participants who were randomized, independent of whether they received study treatment or not. Includes participants who died and participants who were censored||months||95% Confidence Interval|Median
812794|NCT01074047|Secondary|One-year Overall Survival Rate|Kaplan Meier methods were used to estimate the 1-year survival probabilities for time to death from any cause. Estimates of the 1-year (365 day) survival probabilities and corresponding 95% confidence intervals (CI) were presented by treatment group. The CI for the difference in the 1-year survival probabilities was derived using Greenwoods variance estimate.|From Day 1 (randomization) to 40 months|The intent-to-treat (ITT) population was defined as all participants who were randomized, independent of whether they received study treatment or not. Includes participants who died and participants who were censored||percentage of participants||95% Confidence Interval|Number
812795|NCT01074047|Primary|Kaplan-Meier Estimates for Overall Survival|Overall Survival was defined as the time from randomization to death from any cause. Overall survival was calculated by the formula: date of death - date of randomization + 1. Participants surviving at the end of the follow-up period or who withdrew consent to follow-up were censored at the date of last contact. Participants who were lost to follow-up were censored at the date last known alive.|Day 1 (randomization) to 40 months|The intent-to-treat (ITT) population was defined as all participants who were randomized, independent of whether they received study treatment or not. Includes participants who died and participants who were censored||months||95% Confidence Interval|Median
812796|NCT01074099|Primary|Safety|as measured by frequency and severity of adverse events|through 1 Year post tx|||participants|||Number
812797|NCT01074099|Primary|Change in Cardiac Status (Classification)|A change in cardiac status as determined by the New York Heart Association (NYHA) or Canadian Cardiovascular Society (CCS) classification evaluation|Through 12 months post treatment|Study was terminated after enrollment of only 5 patients. The data were not analyzed for efficacy.|||||
812798|NCT01074125|Secondary|Proportion of Patient With a Serum Phosphorus ≤5.5 mg/dL at the End of Treatment|proportion was calculated separately for each treatment arm|Baseline and day 28|Intent-to-Treat||% of Participants|||Number
812799|NCT01074125|Secondary|Pairwise Comparison of the Mean Change in Serum Phosphorus From Baseline to the End of Treatment|Mean change from baseline was calculated separately for each treatment arm. Only subjects that have both baseline and end of treatment serum phosphorus scores were analyzed for this outcome.|Baseline and day 28|Intent-to-Treat, includes only subjects that had both baseline and end of study actual values||mg/dL||Standard Deviation|Mean
812800|NCT01074125|Primary|Change in Serum Phosphorus From Baseline to End of Treatment|Mean change from baseline was calculated separately for each treatment arm (LOCF)|Baseline and day 28|Intent to Treat (ITT) Population||mg/dL||Standard Deviation|Mean
812801|NCT01074164|Secondary|Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Eczema Area and Severity Index (EASI): Lichenification Subscale Score|"The EASI is a composite score assessing four key clinical signs of AD and the area of skin involvement in four main body regions (head, trunk, upper limbs, and lower limbs). The 5 EASI subscales are: erythema, infiltration/papulation, excoriation, lichenification, and percent area of skin involvement. For determining the lichenification subscale score, lichenification is assessed in each main body region and assigned a score of 0 to 3, where a score of 0 is associated with no expression of the clinical sign and a score of 3 is associated with severe expression of the clinical sign. Possible scores range from 0 to 3, where 0 correlates with better disease severity and 3 correlates with worse disease severity.
Hanifin JM, Thurston M, Omoto M, et al (2001) The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis. Exp Dermatol; 10: 11-18."|Baseline and 4 weeks|||units on a scale||Full Range|Median
812802|NCT01074164|Secondary|Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Eczema Area and Severity Index (EASI): Excoriation Subscale Score|"The EASI is a composite score assessing four key clinical signs of AD and the area of skin involvement in four main body regions (head, trunk, upper limbs, and lower limbs). The 5 EASI subscales are: erythema, infiltration/papulation, excoriation, lichenification, and percent area of skin involvement. For determining the excoriation subscale score, excoriation is assessed in each main body region and assigned a score of 0 to 3, where a score of 0 is associated with no expression of the clinical sign and a score of 3 is associated with severe expression of the clinical sign. Possible scores range from 0 to 3, where 0 correlates with better disease severity and 3 correlates with worse disease severity.
Hanifin JM, Thurston M, Omoto M, et al (2001) The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis. Exp Dermatol; 10: 11-18."|Baseline and 4 weeks|||units on a scale||Full Range|Median
812803|NCT01074164|Secondary|Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Eczema Area and Severity Index (EASI): Infiltration/Papulation Subscale Score|"The EASI is a composite score assessing four key clinical signs of AD and the area of skin involvement in four main body regions (head, trunk, upper limbs, and lower limbs). The 5 EASI subscales are: erythema, infiltration/papulation, excoriation, lichenification, and percent area of skin involvement. For determining the infiltration/papulation subscale score, infiltration/papulation is assessed in each main body region and assigned a score of 0 to 3, where a score of 0 is associated with no expression of the clinical sign and a score of 3 is associated with severe expression of the clinical sign. Possible scores range from 0 to 3, where 0 correlates with better disease severity and 3 correlates with worse disease severity.
Hanifin JM, Thurston M, Omoto M, et al (2001) The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis. Exp Dermatol; 10: 11-18."|Baseline and 4 weeks|||units on a scale||Full Range|Median
813062|NCT01076179|Other Pre-specified|Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load|Changes in participants' HIV-1 RNA viral load were assessed by measuring the change from Baseline at scheduled visits planned as part of routine care.|Baseline (Week 0) to Week 144|Participants with an assessment at Baseline. Number analyzed=participants with an assessment at given time point.||log copies/mL||Standard Deviation|Mean
812804|NCT01074164|Secondary|Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Eczema Area and Severity Index (EASI): Erythema Subscale Score|"The EASI is a composite score assessing four key clinical signs of AD and the area of skin involvement in four main body regions (head, trunk, upper limbs, and lower limbs). The 5 EASI subscales are: erythema, infiltration/papulation, excoriation, lichenification, and percent area of skin involvement. For determining the erythema subscale score, erythema is assessed in each main body region and assigned a score of 0 to 3, where a score of 0 is associated with no expression of the clinical sign and a score of 3 is associated with severe expression of the clinical sign. Possible scores range from 0 to 3, where 0 correlates with better disease severity and 3 correlates with worse disease severity.
Hanifin JM, Thurston M, Omoto M, et al (2001) The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis. Exp Dermatol; 10: 11-18."|Baseline and 4 weeks|||units on a scale||Full Range|Median
812805|NCT01074164|Secondary|Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Eczema Area and Severity Index (EASI): Area Subscale Score|"The EASI is a composite score assessing four key clinical signs of AD and the area of skin involvement in four main body regions (head, trunk, upper limbs, and lower limbs). The 5 EASI subscales are: erythema, infiltration/papulation, excoriation, lichenification, and percent area of skin involvement. For determining area subscale score, the percent area of skin involvement is determined and assigned a score of 0 to 6, where 0 correlates with no skin involvement, 1 represents < 10% skin involvement, 2 represents 10-29% skin involvement, 3 represents 30-49% skin involvement, 4 represents 50-69% skin involvement, 5 represents 70-89% skin involvement, and 6 represents 90-100% skin involvement. Possible scores range from 0 to 6, where 0 correlates with better disease severity and 6 correlates with worse disease severity.
Hanifin JM, Thurston M, Omoto M, et al (2001) The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis. Exp Dermatol; 10: 11-18."|Baseline and 4 weeks|||units on a scale||Full Range|Median
812806|NCT01074164|Secondary|Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Investigator Global Assessment (IGA) Score|The IGA score is an assessment of AD severity. It is an assessment of the patient's disease state at the time of examination and does not attempt a comparison with any of the patient's previous disease states. Possible scores range from 0 to 5. A score of 0 is associated with no evidence of AD and a score of 5 is associated with severe AD.|Baseline and 4 weeks|||units on a scale||Full Range|Mean
812807|NCT01074164|Primary|Change in Itch Intensity as Measured by a Change in Visual Analog Scale (VAS) Score|The VAS score assesses itch intensity in subject’s with AD. The VAS consists of a 21.5 cm horizontal line with its left and right boundaries marked by vertical lines. The left boundary vertical line is labeled “Least Itch,” and the right boundary vertical line is labeled “Worst Itch.” Subjects are instructed to draw a vertical line across this scale that represents the intensity of itch that they are currently experiencing. Vertical lines drawn by subjects towards the left boundary of the horizontal line are associated with less itch intensity, and vertical lines drawn by subjects towards the right boundary of the horizontal line are associated with worse itch intensity. A ruler is then used to measure distance from the left boundary vertical line to the vertical line drawn by the subject to the nearest millimeter. Possible values range from 0 to 21.5 centimeters, with 0 centimeters associated with less itch intensity and 21.5 cm associated with worse itch intensity.|Baseline and 4 weeks|||centimeters||Full Range|Mean
812808|NCT01074216|Primary|To Achieve Target Vitamin D Level|To determine the ability of achieving the target serum 25-hydroxy vitamin D level of 40 ng/ml within 6 weeks of beginning vitamin D supplements in patients with metastatic colon cancer. A response is defined as achieving serum vitamin D levels ≥40 ng/ml at least once at any point during the first 6 weeks|Within 6 weeks of beginning vitamin D|||participants|||Number
812809|NCT01074229|Secondary|24 Total Morphine Consumption|Total 24 total morphine consumption post operative.|1 day|||miligrams of morphine||Standard Deviation|Mean
812810|NCT01074229|Primary|QoR40 on the Day After Surgery|QoR40 on the day after surgery. Quality of recovery is based on a score of 40-200. 40 being a poor recovery and 200 being a good recovery score.|1 day|||units on a scale||Inter-Quartile Range|Median
812811|NCT01074242|Primary|Percentage of Participants With Any Adverse Drug Reaction|An adverse drug reaction was an adverse experience for which a causal relationship to the study drug could not be ruled out|Up to 42 days after any Rotateq vaccination|All enrolled participants who received at least 1 dose of study vaccine were included in the analysis||Percent of participants|||Number
812812|NCT01074242|Primary|Percentage of Participants With Any Adverse Experience|An adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse experience.|Up to 42 days after any Rotateq vaccination|All enrolled participants who received at least 1 dose of study vaccine were included in the analysis||Percent of participants|||Number
812813|NCT01074255|Primary|Investigator Global Assessment of Participants' Response to Therapy With EMEND (Aprepitant) for the Prevention of Acute and Delayed Nausea Following Chemotherapy|The investigators assessed a participant's response to therapy with EMEND to prevent acute and delayed nausea and vomiting associated with initial and repeat courses of chemotherapy when used concomitantly with other antiemetics. The response categories were: excellent (best possible anticipated response, considering the severity and stage of disease), good (good response, but less than the best possible anticipated response), fair (definite response, but could be better), poor (minimal response, unacceptable), or none (no response, absence of drug effect).|Up to 14 days following the cessation of treatment|The Efficacy Evaluable Population consisted of participants treated with EMEND for 3 days and assessed by an investigator for efficacy. Participants were excluded from efficacy analysis for having a EMEND administration period less than 3 days (143 participants) or unavailability of final efficacy evaluation (1 participant).||participants|||Number
812839|NCT01067976|Other Pre-specified|Blinded Readers: Inter-reader Agreement on Categorical Accuracy Based on Assessment for UMRM vs CMRM - Breast Region Level|Inter-reader agreement was assessed by considering each breast region to have 2 possibilities (malignant disease / no malignant disease) for an assessment by the 2 image sets (UMRM and CMRM). Kappa value varies from 0 (no agreement) to 1 (perfect agreement).|Immediately before injection and after injection|All participants in the FAS with assessments for this outcome measure.||kappa|Participants||Number
812814|NCT01074268|Primary|Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)|Rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no/transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect or important medical issues|Week 0 to Week 52 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator in the main trial including subjects carried through to the extension trial.||Events/100 years of patient exposure|||Number
812815|NCT01074268|Secondary|Extension Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes: episodes requiring active assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes: episodes where subject was able to treat her/himself and plasma glucose below 3.1 mmol/L, with or without symptoms. Nocturnal hypoglycaemic episodes are defined as occuring between 00:01 and 05:59 a.m.|Week 0 to Week 52 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator in the main trial including subjects carried through to the extension trial.||Episodes/100 years of patient exposure|||Number
812816|NCT01074268|Secondary|Extension Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes: episodes requiring active assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes: episodes where the subject was able to treat her/himself and plasma glucose below 3.1 mmol/L with or without symptoms|Week 0 to Week 52 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator in the main trial including subjects carried through to the extension trial.||Episodes/100 years of patient exposure|||Number
812817|NCT01074268|Secondary|Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes: episodes requiring active assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes: episodes where subject was able to treat her/himself and plasma glucose below 3.1 mmol/L, with or without symptoms. Nocturnal hypoglycaemic episodes are defined as occuring between 00:01 and 05:59 a.m.|Week 0 to Week 26 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator.||Episodes/100 years of patient exposure|||Number
812818|NCT01074268|Secondary|Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes: episodes requiring active assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes: episodes where the subject was able to treat her/himself and plasma glucose below 3.1 mmol/L, with or without symptoms.|Week 0 to Week 26 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator.||Episodes/100 years of patient exposure|||Number
812819|NCT01074268|Secondary|Extension Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment|Change from baseline in FPG after 52 weeks of treatment|Week 0, Week 52|The FAS included all randomised subjects in the main trial including subjects carried through to the extension trial and missing data was imputed using LOCF. For 6 subjects change in FPG values were missing.||mmol/L||Standard Deviation|Mean
812820|NCT01074268|Secondary|Main Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 26 Weeks of Treatment|Change from baseline in FPG after 26 weeks of treatment|Week 0, Week 26|The FAS included all randomised subjects and missing data was imputed using LOCF. For 6 subjects change in FPG values were missing.||mmol/L||Standard Deviation|Mean
812821|NCT01074268|Secondary|Extension Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 52|Mean of 9-point self-measured plasma glucose profile (SMPG) at week 52. Plasma glucose was measured before breakfast, 90 minutes after the start of breakfast, before lunch, 90 minutes after the start of lunch, before main evening meal, 90 minutes after the start of main evening meal, before bedtime, at 04:00 AM and before breakfast on the following day.|Week 52|The FAS included all randomised subjects in the main trial including subjects carried through to the extension trial and missing data was imputed using LOCF. For 4 subjects all 9-point SMPG values were missing.||mmol/L||Standard Deviation|Mean
812822|NCT01074268|Secondary|Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26|Mean of 9-point self-measured plasma glucose profile (SMPG) after week 26. Plasma glucose was measured before breakfast, 90 minutes after the start of breakfast, before lunch, 90 minutes after the start of lunch, before main evening meal, 90 minutes after the start of main evening meal, before bedtime, at 04:00 AM and before breakfast on the following day.|Week 26|The FAS included all randomised subjects and missing data was imputed using LOCF. For 5 subjects, all 9-point SMPG values were missing.||mmol/L||Standard Deviation|Mean
812823|NCT01074268|Secondary|Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment|Change from baseline in HbA1c after 52 weeks of treatment|Week 0, Week 52|The FAS included all randomised subjects in the main trial including subjects carried through to the extension trial and missing data was imputed using LOCF.||percentage of glycosylated haemoglobin||Standard Deviation|Mean
812824|NCT01074268|Primary|Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment|Change from baseline in HbA1c after 26 weeks of treatment|Week 0, Week 26|The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF).||percentage of glycosylated haemoglobin||Standard Deviation|Mean
812828|NCT01074307|Secondary|Change From Baseline in Echocardiographic Left Ventricular Size at Week 26|Left ventricle size was measured as systolic and diastolic Left Ventricular Internal Dimension (LVID). Diastolic dimension was measured of the left ventricle at the level of the chordae tendineae. The systolic dimension was measured as the smallest dimension between the left septal endocardium and the posterior wall endocardium during systole, whether or not the two walls were exactly apposed.|Baseline and Week 26|ITT population included all the randomized participants who had at least one dose of the investigational product. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure. 'n' signifies number of participants who were evaluable for specified categories at different time points.||Milliliter LVID||Standard Deviation|Mean
812829|NCT01074307|Secondary|Change From Baseline in Echocardiographic Left Ventricular Ejection Fraction (LVEF) at Week 26|LVEF was defined as the fraction of blood (in percent) pumped out of the heart's left ventricular chamber with each heart beat and it is used to measure the cardiac output for the heart.|Baseline and Week 26|ITT population included all the randomized participants who had at least one dose of the investigational product. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure. 'n' signifies number of participants who were evaluable for specified categories at different time points.||Percent LVEF||Standard Deviation|Mean
812830|NCT01074307|Secondary|Change From Baseline in 6-minute Walking Test (6-MWT) Distance at Week 26|6-minute Walking Test (6-MWT) distance was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed.|Baseline and Week 26|ITT population included all the randomized participants who had at least one dose of the investigational product. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure. 'n' signifies number of participants who were evaluable for specified categories at different time points.||Meter||Standard Deviation|Mean
812831|NCT01074307|Secondary|Percentage of Participants Classified as Class I to IV According to New York Heart Association (NYHA)|New York Heart Association (NYHA) classification of heart failure: Class I: No limitation: ordinary physical exercise does not cause undue fatigue, dyspnea, or palpitations. Class II: Slight limitation of physical activity: comfortable at rest but ordinary activity results in fatigue, palpitations, or dyspnea. Class III: Marked limitation of physical activity: comfortable at rest but less than ordinary activity results in symptoms. Class IV: Unable to carry out any physical activity without discomfort: symptoms of heart failure are present even at rest with increased discomfort with any physical activity.|Baseline and Week 26|ITT population included all the randomized participants who had at least one dose of the investigational product.||Percentage of participants|||Number
812832|NCT01074307|Primary|Percent Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 26|B-type natriuretic peptide (BNP) is a substance secreted from the ventricles or lower chambers of the heart in response to changes in pressure that occur when heart failure develops and worsens. The level of BNP in the blood increases when heart failure symptoms worsen, and decreases when the heart failure condition is stable. The BNP level in a person with heart failure is higher than in a person with normal heart function. The percent change of NT-pro BNP was calculated according to the formula: N-terminal pro B-type natriuretic peptide (NT-proBNP) reduction ratio = 100*(Baseline NT-proBNP - Week 26 NT-proBNP)/Baseline NT-proBNP.|Baseline and Week 26|ITT population included all the randomized participants who had at least one dose of the investigational product. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.||Percent change||Standard Deviation|Mean
812833|NCT01067976|Other Pre-specified|Number of Participants With at Least One Laboratory Parameter Change From Low or Normal at Baseline to Abnormally High at Follow–up 24 Hours Post Injection|Number of participants with at least one occurrence of changing from low or normal at baseline to high at follow-up.|Baseline, Follow–up visit (24 hours post injection)|Safety Analysis Set (SAF): The analysis of safety data was performed using all available data from all participants who administered any amount of gadobutrol.||participants|||Number
812834|NCT01067976|Other Pre-specified|Vital Signs Change From Baseline and Follow–up 24 Hours Post Injection - Heart Rate|Heart rate was measured in a supine position.|Baseline, Follow–up visit (24 hours post injection)|Safety Analysis Set (SAF): The analysis of safety data was performed using all available data from all participants who administered any amount of gadobutrol.||beats/min||Standard Deviation|Mean
812835|NCT01067976|Other Pre-specified|Vital Signs Change From Baseline and Follow–up 24 Hours Post Injection - Systolic and Diastolic Blood Pressure|Systolic and diastolic blood pressure were measured in a supine position. Blood pressure was not to be measured on the arm used for the injection.|Baseline, Follow–up visit (24 hours post injection)|Safety Analysis Set (SAF): The analysis of safety data was performed using all available data from all participants who administered any amount of gadobutrol.||mmHg||Standard Deviation|Mean
812836|NCT01067976|Other Pre-specified|Blinded Reader 3: Intra-reader Variability Based on Assessment for CMRM - Breast Level|Intra-reader variability was assessed using a kappa on the match to SoT for the different regions within each participant (match, no match SoT). For each of the 3 readers, intra-reader agreement was assessed by considering each breast region to have 2 possibilities for an assessment by CMRM: matched SoT or did not match SoT. Kappa value varies from 0 (no agreement) to 1 (perfect agreement).|Immediately before injection and after injection|All participants in the FAS with assessments for this outcome measure.||Kappa|Participants||Number
812837|NCT01067976|Other Pre-specified|Blinded Reader 2: Intra-reader Variability Based on Assessment for CMRM - Breast Level|Intra-reader variability was assessed using a kappa on the match to SoT for the different regions within each participant (match, no match SoT). For each of the 3 readers, intra-reader agreement was assessed by considering each breast region to have 2 possibilities for an assessment by CMRM: matched SoT or did not match SoT. Kappa value varies from 0 (no agreement) to 1 (perfect agreement).|Immediately before injection and after injection|All participants in the FAS with assessments for this outcome measure||Kappa|Participants||Number
812838|NCT01067976|Other Pre-specified|Blinded Reader 1: Intra-reader Variability Based on Assessment for CMRM - Breast Level|Intra-reader variability was assessed using a kappa on the match to SoT for the different regions within each participant (match, no match SoT). For each of the 3 readers, intra-reader agreement was assessed by considering each breast region to have 2 possibilities for an assessment by CMRM: matched SoT or did not match SoT. Kappa value varies from 0 (no agreement) to 1 (perfect agreement).|Immediately before injection and after injection|All participants in the FAS with assessments for this outcome measure.||Kappa|Participants||Number
812840|NCT01067976|Other Pre-specified|Difference of Confidence in Diagnosis for Breast Region Diagnosis Using CMRM vs UMRM, CMRM+XRM vs UMRM+XRM and CMRM+XRM vs XRM by Majority Reader, Participant Level|The 3 blinded readers each recorded his/her confidence in diagnosis for each breast region based on a 4-point scale (1=not confident, 2=somewhat confident, 3=confident, and 4=very confident). The majority read value for the 3 readers was determined at the disease state level (no disease, unifocal, multifocal). If 2 of 3 or all 3 readers gave the same categorical determination of malignant disease for a breast region, the majority reader response was that category. If all 3 readers gave different categorical determination, the majority reader response was the most severe disease category given by any of the 3 readers, i.e. multifocal. For each participant, the mean of the confidence responses for the diagnosed breast regions was calculated, and rounded to the nearest 0.5. value respectively. The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|All participants in the FAS with assessments by the majority reader for both modalities in the comparison for this assessment. Majority reader results are based on the average of the 3 blinded readers’s assessment.||difference of scores on a scale|Participants|90% Confidence Interval|Mean
812841|NCT01067976|Other Pre-specified|Accuracy Difference of Presence of Bilateral Malignant Disease Verified by SoT by Majority Reader, Participant Level|The disease state “bilateral malignant disease” was derived from the assessment of the different regions for each breast (right and left) for investigators for each imaging modality (UMRM, CMRM, XRM, UMRM+XRM, and CMRM+XRM) based on the following rule: If the participant had at least one breast with no malignant region, the assessment of bilateral malignant disease was categorized as “No”. If the participant had at least one malignant lesion in both breasts, the assessment of bilateral malignant disease was categorized as “Yes”. The proportion of correct matches of each different image set to the SoT for the existence of bilateral malignant disease was derived. The analysis was based on the difference in accuracy for the evaluation of bilateral malignant disease for the following image comparisons on a participant level. The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|The analyses were based on 388 participants; evaluable subjects with at least one region verified by SoT in each breast with available CMRM, UMRM, CMRM+XRM, UMRM+XRM and XRM assessment.||difference in accuracy (%)||95% Confidence Interval|Mean
812842|NCT01067976|Other Pre-specified|Sensitivity Difference of Detection of Multicentric Malignant Disease Verified by SoT by Majority Reader, Breast Level|For a single participant the sensitivity was defined as the proportion of malignant breast regions that were recognized by the reader using the respective imaging modality as malignant. Subsequently the sensitivity percentage was calculated based on the mean of the sensitivities across all participants. The majority read value for the 3 blinded readers was determined at the disease state level (evaluable regions for sensitivity). If 2 of 3 or all 3 readers gave the same categorical determination of malignant disease for a breast region, the majority reader response was that category. If all 3 readers gave a different categorical determination, the majority response was the most severe disease category given by any of the 3 readers. The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|The analyses were based on a total number of 53 evaluable breasts with multicentric malignant disease.||difference in sensitivity (%)|Participants|95% Confidence Interval|Mean
812843|NCT01067976|Other Pre-specified|Specificity Difference in the Determination of Multifocal Malignant Breast Disease Using CMRM vs UMRM, CMRM+XRM vs UMRM+XRM, and CMRM+XRM vs XRM Verified by SoT, Breast Region Level|A malignant breast was defined as FP, when the reader using the respective imaging modality assessed more breast regions as malignant as were present according to SoT. Otherwise the breast was assessed as TN. Specificity was then defined as TN/(TN+FP). The majority read value for the 3 blinded readers was determined at the disease state level (evaluable regions for specificity). If 2 of 3 or all 3 readers gave the same categorical determination of malignant disease for a breast region, the majority reader response was that category. If all 3 readers gave a different categorical determination, the majority reader response was the most severe disease category given by any of the 3 readers. The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Single examination|For multifocal malignant disease, specificity analyses were based on a total number of 3816 regions, 390 participants in FAS.||difference in specificity (%)|Participants|95% Confidence Interval|Mean
812844|NCT01067976|Other Pre-specified|Specificity Difference in the Determination of Unifocal Malignant Breast Disease Using CMRM vs UMRM, CMRM+XRM vs UMRM+XRM, and CMRM+XRM vs XRM Verified by SoT, Breast Region Level|A malignant breast was defined as FP, when the reader using the respective imaging modality assessed more breast regions as malignant as were present according to SoT. Otherwise the breast was assessed as TN. Specificity was then defined as TN/(TN+FP). The majority read value for the 3 blinded readers was determined at the disease state level (evaluable regions for specificity). If 2 of 3 or all 3 readers gave the same categorical determination of malignant disease for a breast region, the majority reader response was that category. If all 3 readers gave a different categorical determination, the majority reader response was the most severe disease category given by any of the 3 readers. The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|For unifocal malignant disease, specificity analyses were based on a total number of 3307 regions (i.e. regions with no disease or multifocal malignant disease), 390 participants in FAS.||difference in specificity (%)|Participants|95% Confidence Interval|Mean
812851|NCT01067976|Other Pre-specified|Breast Level Specificity for All Breasts by Imaging Modality and by Reader|A non-malignant breast was defined as FP when the reader assessed at least one breast region as malignant. A malignant breast was defined as FP, when the reader using the respective imaging modality assessed more breast regions as malignant as were present according to SoT. Otherwise the breast was assessed as TN. Specificity was then defined as (N–FP)/N, where N was total number of breasts.|Immediately before injection and after injection|The analyses were based on 390 participants; evaluable for specificity were breasts with or without malignant disease verified by SoT for which assessment by the imaging modality were available.||specificity (%)||95% Confidence Interval|Mean
824831|NCT01178268|Secondary|Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)||9 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
812845|NCT01067976|Other Pre-specified|Specificity Difference in the Determination of Malignant Breast Disease Using CMRM vs UMRM, CMRM+XRM vs UMRM+XRM, and CMRM+XRM vs XRM Verified by SoT, Breast Region Level|A malignant breast was defined as FP, when the reader using the respective imaging modality assessed more breast regions as malignant as were present according to SoT. Otherwise the breast was assessed as TN. Specificity was then defined as TN/(TN+FP). The majority read value for the 3 blinded readers was determined at the disease state level (evaluable regions for specificity). If 2 of 3 or all 3 readers gave the same categorical determination of malignant disease for a breast region, the majority reader response was that category. If all 3 readers gave a different categorical determination, the majority reader response was the most severe disease category given by any of the 3 readers. The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|The analyses were performed for a total number of 3240 regions, 390 participants in FAS.||difference in specificity (%)|Participants|95% Confidence Interval|Mean
812846|NCT01067976|Other Pre-specified|Sensitivity Difference in the Determination of Multifocal Malignant Breast Disease Using CMRM vs UMRM, CMRM+XRM vs UMRM+XRM, and CMRM+XRM vs XRM Verified by SoT, Breast Region Level|For a single participant the sensitivity was defined as the proportion of malignant breast regions that were recognized by the reader using the respective imaging modality as malignant. Subsequently the sensitivity percentage was calculated based on the mean of the sensitivities across all participants. The majority read value for the 3 blinded readers was determined at the disease state level (evaluable regions for sensitivity). If 2 of 3 or all 3 readers gave the same categorical determination of malignant disease for a breast region, the majority reader response was that category. If all 3 readers gave a different categorical determination, the majority response was the most severe disease category given by any of the 3 readers. The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|For multifocal malignant disease, sensitivity analyses were performed for a total number of 67 regions.||difference in sensitivity (%)|Participants|95% Confidence Interval|Mean
812847|NCT01067976|Other Pre-specified|Sensitivity Difference in the Determination of Unifocal Malignant Breast Disease Using CMRM vs UMRM, CMRM+XRM vs UMRM+XRM, and CMRM+XRM vs XRM Verified by SoT, Breast Region Level|For a single participant the sensitivity was defined as the proportion of malignant breast regions that were recognized by the reader using the respective imaging modality as malignant. Subsequently the sensitivity percentage was calculated based on the mean of the sensitivities across all participants. The majority read value for the 3 blinded readers was determined at the disease state level (evaluable regions for sensitivity). If 2 of 3 or all 3 readers gave the same categorical determination of malignant disease for a breast region, the majority reader response was that category. If all 3 readers gave a different categorical determination, the majority response was the most severe disease category given by any of the 3 readers. The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|For unifocal malignant disease, sensitivity analyses were performed for a total number of 576 regions (i.e. regions with unifocal disease verified by SoT), 390 participants in FAS.||difference in sensitivity (%)|Participants|95% Confidence Interval|Mean
812848|NCT01067976|Other Pre-specified|Sensitivity Difference in the Determination of Malignant Breast Disease Using CMRM vs UMRM, CMRM+XRM vs UMRM+XRM, and CMRM+XRM vs XRM Verified by SoT, Breast Region Level|For a single participant the sensitivity was defined as the proportion of malignant breast regions that were recognized by the reader using the respective imaging modality as malignant. Subsequently the sensitivity percentage was calculated based on the mean of the sensitivities across all participants. The majority read value for the 3 blinded readers was determined at the disease state level (evaluable regions for sensitivity). If 2 of 3 or all 3 readers gave the same categorical determination of malignant disease for a breast region, the majority reader response was that category. If all 3 readers gave a different categorical determination, the majority response was the most severe disease category given by any of the 3 readers. The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|The analyses were performed for a total number of 643 regions, 390 participants in FAS. Regions with malignant disease verified by SoT comprise unifocal and multifocal regions.||difference in sensitivity (%)|Participants|95% Confidence Interval|Mean
812849|NCT01067976|Other Pre-specified|Categorical Accuracy Difference of Extent of Malignant Disease Verified by Histopathology by Majority Reader, Breast Region Level|For each region the reader chose the category which best described the extent of malignant disease, i.e. no, unifocal, or multifocal malignant breast disease. The proportion of correct matches of each defined image set to the SoT for the extent of malignant breast disease was referred to as the categorical accuracy. The majority read value for the 3 blinded readers was determined at the disease state level (no disease, unifocal, multifocal). If 2 of 3 or all 3 readers gave the same categorical determination of malignant disease for a breast region, the majority reader response was that category. If all 3 readers gave different categorical determination, the majority reader response was the most severe disease category given by any of the 3 readers. The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|The analyses were performed for a total number of 1120 regions, 390 participants from FAS.||percent difference|Participants|95% Confidence Interval|Mean
812850|NCT01067976|Other Pre-specified|Categorical Accuracy Difference of Extent of Malignant Disease Verified by SoT by Majority Reader, Breast Region Level|For each region the reader chose the category which best described the extent of malignant disease, i.e. no, unifocal, or multifocal malignant breast disease. The proportion of correct matches of each defined image set to the SoT for the extent of malignant breast disease was referred to as the categorical accuracy. The majority read value for the 3 blinded readers was determined at the disease state level (no disease, unifocal, multifocal). If 2 of 3 or all 3 readers gave the same categorical determination of malignant disease for a breast region, the majority reader response was that category. If all 3 readers gave different categorical determination, the majority reader response was the most severe disease category given by any of the 3 readers. The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|The analyses were performed for a total number of 3883 regions, 390 participants in FAS.||percent difference|Participants|95% Confidence Interval|Mean
812852|NCT01067976|Secondary|Percentage Difference of Participants Whose Additional Cancers Were Detected Using CMRM vs UMRM, CMRM vs XRM, and CMRM vs CMRM+XRM|Additional cancer was defined as cancer which was present according to SoT, but which was not defined as index cancer, i.e. was not known when the participant was enrolled into the study. The difference in percentage of participants was calculated as CMRM value minus UMRM value, CMRM value minus XRM value, CMRM value minus CMRM+XRM value respectively.|Immediately before injection and after injection|The analyses were based on 87 participants in FAS who had at least one additional cancer region according to SoT.||difference in percentage of participants||95% Confidence Interval|Number
812853|NCT01067976|Secondary|Percentage Difference of Participants Whose Index Cancers Were Detected Using CMRM vs UMRM, CMRM vs XRM, and CMRM vs CMRM+XRM|Index cancer is defined as the cancer confirmed by histology prior to inclusion which made the participants eligible for the study. The difference in percentage of participants was calculated as CMRM value minus UMRM value, CMRM value minus XRM value, CMRM value minus CMRM+XRM value respectively.|Immediately before injection and after injection|The analyses were based on 382 participants in FAS. Index cancer was defined as the cancer confirmed by histology prior to inclusion which made the participant eligible for the study.||difference in percentage of participants||95% Confidence Interval|Number
812854|NCT01067976|Secondary|Breast Level Specificity of CMRM Based on Malignant Breasts|A malignant breast was defined as false positive (FP), when the reader using the respective imaging modality assessed more breast regions as malignant as were present according to SoT. Otherwise the breast was assessed as true negative (TN). Specificity was then defined as TN/(TN+FP).|Immediately before injection and after injection|The analyses were based on 388 participants in FAS; evaluable for specificity were breasts with malignant disease verified by SoT for which an assessment by the imaging modality was available.||specificity (%)||95% Confidence Interval|Mean
812855|NCT01067976|Primary|Breast Level Specificity of CMRM for Non-malignant Breasts by Reader|A non-malignant breast was defined as false positive (FP), when the reader assessed at least one breast region as malignant. When all breast regions were assessed as non-malignant, the breast was defined as true negative (TN). Breast level specificity was first defined in participant as number of TN-breasts in participant divided by number of non-malignant breasts in participant. Subsequently the specificity percentage was calculated based on the mean of the specificities across all participants who contributed with at least one non-malignant breast.|Immediately before injection and after injection|The analyses were based on 372 participants in FAS; evaluable for specificity were breasts without malignant disease as verified by Standard of Truth (SOT).||specificity (%)||95% Confidence Interval|Mean
812856|NCT01067976|Primary|Sensitivity for Detection of Full Extent of Malignant Breast Disease Using CMRM vs UMRM Per Reader|For a single participant the sensitivity was defined as the proportion of malignant breast regions that were recognized by the clinical investigators and the 3 blinded readers using the respective imaging modality as malignant. Subsequently the sensitivity percentage was calculated based on the mean of the sensitivities across all participants.|Immediately before injection and after injection|The analyses were based on 388 participants in the Full Analysis Set (FAS) who had regions with malignant disease verified by Standard of Truth (SOT).||sensitivity %||95% Confidence Interval|Mean
812857|NCT01067976|Primary|Difference for Sensitivity for Detection of Full Extent of Malignant Breast Disease Using CMRM vs UMRM Per Reader|For a single participant the sensitivity was defined as the proportion of malignant breast regions that were recognized by the clinical investigators and the 3 blinded readers using the respective imaging modality as malignant. Subsequently the sensitivity percentage was calculated based on the mean of the sensitivities across all participants. The difference was calculated as CMRM value minus UMRM value. For ease of expression, the following abbreviations will be used: Magnetic Resonance Mammography (MRM), Unenhanced MRM (UMRM), combined unenhanced and contrast (gadobutrol)-enhanced MRM (CMRM), X-ray mammography (XRM).|Immediately before injection and after injection|The analyses were based on 388 participants in the Full Analysis Set (FAS) who had regions with malignant disease verified by Standard of Truth (SOT).||difference in sensitivity (%)||95% Confidence Interval|Mean
812858|NCT01074437|Primary|Lesion Regression|measure of change in lesion area or volume|12 months|Insufficient enrollment for data analysis to be meaningful.|||||
812859|NCT01074437|Secondary|Demonstrate How Duplex Scanning to Assess Blood Vessel Density and Qualitative Color Ratings of Cutaneous Lesions From Photographs Can be Used to Measure and Quantify Changes in IH Size and Vascularity in a Clinically Relevant Manner.||1, 2 and 6 months after treatment initiation||||||
812860|NCT01074437|Secondary|Assess the Safety of Propranolol With Corticosteroids and Corticosteroids Alone in the Treatment of IH.||1, 2 and 6 months after treatment initiation||||||
812861|NCT01074437|Secondary|Determine Therapeutic Response of IH to Propranolol Among Patients Who Switch to Corticosteroids Plus Propranolol Therapy After Failing to Respond to Corticosteroids Alone.||1, 2, and 6 months after treatment initiation||||||
812862|NCT01074437|Primary|Compare Changes in IH Size and Vascularity for Subjects Randomized to Receive Initial Treatment With Corticosteroid-only Therapy Versus Combination Therapy With Corticosteroids Plus Propranolol||1, 2, and 6 months after treatment initiation||||||
812863|NCT01074450|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
812864|NCT01074450|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
812865|NCT01074450|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Cmax.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
812866|NCT01074463|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
812867|NCT01074463|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
812879|NCT01074658|Secondary|Percentage of Participants With Device Success|"Device Success is defined as a composite of:
Successful device delivery;
Stable device placement;
Intact retrieval of delivery catheter;
Successful device function as assessed immediately post-procedure by angiography including non-compromised flow in coronary arteries (without obstruction) device position (no migration) and a mean gradient as determined invasively of <15mmHg and ≤ 2 aortic regurgitation"|up to 24 hours|All attempted population in which the separate variables related to device success (see outcome measure description) were analyzable.||percentage of participants|||Number
812880|NCT01074658|Primary|Major Adverse Cardiac & Cerebrovascular Events (MACCE)|"MACCE is defined as a composite of:
All cause mortality
Myocardial Infarction (Q-wave and non-Q-wave)
Emergent cardiac surgery or percutaneous re-intervention
Stroke
The Kaplan-Meier survival analysis was used to derive the freedom from MACCE at 30 days."|30 days|All attempted population.||Freedom from MACCE (%) @30days|||Number
812881|NCT01075074|Secondary|Time to Hospital Discharge Readiness|Elapsed time from post anesthesia care unit to readiness to hospital discharge. Assessment were made using the modified post anesthetic discharge scoring system. This assess 5 criteria: vital signs, activity and mental status, pain nausea and/or vomiting, surgical bleed, and intake and output. A score greater than or equal to 9 (on a 0 to 10 scale) is considered ready for discharge.|24 hours|75 subjects were randomized in 3 groups of 25, 5 were excluded from analysis because the surgeon had to proceed to an open incision from a laparoscopic case during the procedure.||minutes||Inter-Quartile Range|Median
812882|NCT01075074|Secondary|Opioid Pain Medications Consumed During the First 24 Hours Post Surgery|Opioid consumption in oral morphine equivalents taken by the subject for pain during the first 24 hours post hospital discharge|24 hours|75 subjects were randomized in 3 groups of 25, 5 were excluded from analysis because the surgeon had to proceed to an open incision from a laparoscopic case during the procedure.||mEq of PO morphine equivalent||Full Range|Mean
812883|NCT01075074|Secondary|Pain Burden During Early Recovery From Anesthesia|Area under the numeric rating scale for pain versus time (min) curve during the post anesthesia care admission. Numeric rating scale 0 to 10 with 0 equals no pain and 10 equals worst pain imaginable.|Post Operative|75 subjects were randomized in 3 groups of 25, 5 were excluded from analysis because the surgeon had to proceed to an open incision from a laparoscopic case during the procedure.||score on a scale * minutes||Inter-Quartile Range|Median
812884|NCT01075074|Primary|The Quality of Recovery Questionnaire (QoR40) on the Day (24 Hours) After Surgery|The quality of recovery questionnaire (QOR40) is a 40 question assessment of patient recovery following surgery. It evaluates 5 domains of recovery: pain, emotional status, physical comfort, physical independence, and support. Each question is scores on a 1 to 5 Likert scale with total scores ranging for 40, representing poor recovery, to 200, representing outstanding recovery.|24 hours after surgery|75 subjects were randomized in 3 groups of 25, 5 were excluded from analysis because the surgeon had to proceed to an open incision from a laparoscopic case during the procedure.||units on a scale||Full Range|Median
812885|NCT01075087|Secondary|24 Hour Total Opioid Consumption.|24 Hour total opioid consumption translated into IV morphine equivalents.|24 hours|||miligram IV morphine equivalents||Inter-Quartile Range|Median
812886|NCT01075087|Primary|Quality of Recovery 40 Score|Quality of Recovery 40 Score at 24 hours postoperative.|24 hours post operatively|||units on scale 40 (low) - 200 (high)||Inter-Quartile Range|Median
812887|NCT01075100|Secondary|Duration of Response|The duration of response is measured from the time measurement criteria are first met for CR/PR until the first date that recurrent or progressive disease is objectively documented.|30 months|Patients who achieved CR or PR.||months||Full Range|Median
812888|NCT01075100|Secondary|Time to Response|For patients who achieve a major objective response (CR or PR) the time to response will be assessed as the date of registration to the date of response.|24 months|Patients who achieve a major objective response (CR or PR).||months||Full Range|Median
812889|NCT01075100|Secondary|Overall Survival (OS)|OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.|24 months|ITT population||months||95% Confidence Interval|Median
812890|NCT01075100|Secondary|Progression-free Survival (PFS)|"PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions"|24 months|ITT population||months||95% Confidence Interval|Median
812891|NCT01075100|Secondary|Clinical Benefit Rate (CBR)|Clinical benefit rate (CBR) defined as objective response rate (ORR, CR + PR) + SD >= 6 months|24 months|Evaluable population||percentage of participants||95% Confidence Interval|Number
812892|NCT01075100|Primary|Objective Response Rate (ORR)|"Evaluate the objective response rate calculated as CR+ PR in the population evaluable for response, as well as the 2 subgroups (hormone receptor positive [ER+/PR+/HER2-, ER+/PR-/HER2-, ER-/PR+/HER2-]) and ER-/PR-HER2-, separately).
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|24 months|Evaluable population||percentage of participants||95% Confidence Interval|Number
812893|NCT01075152|Other Pre-specified|Percentage of Participants, Per CSF WBC Subgroup, Who Died by Week 26|Percentage of Participants who died by week 26 based on CSF white blood cell (WBC) count at study entry (time of randomization at a median of 8 days of anti-fungal therapy).|26 weeks|among persons with a measured CSF white cell count at randomization (Day 7-11 of amphotericin treatment)||percentage of participants|||Number
812894|NCT01075152|Secondary|Microbiologic Clearance|Microbiologic clearance of cryptococcus as measured by serial quantitative cryptococcal cultures collected at diagnosis through 14 days of amphotericin therapy. The early fungicidal activity (EFA) of the rate of clearance is expressed as log10 colony forming units (CFU) of Cryptococcus neoformans per mL of CSF per day.|4 weeks|All participants with >2 quantitative CSF cultures obtained||log10 CFU/mL/day||95% Confidence Interval|Mean
813986|NCT01083602|Secondary|Responders to Treatment|The primary endpoint for this phase II study of patients with bortezomib-refractory MM is response after a maximum of 8 cycles of therapy as defined by the modified EBMT criteria.|after eight cycyles of treatment (24 weeks)|Full Analysis Set||participants|||Number
812895|NCT01075152|Secondary|Karnofsky Functional Status|"Functional status via Karnofsky performance status score at 4, 26, 46 weeks.
Karnofsky Scale:
100 - Normal; no complaints; no evidence of disease. 90 - Able to carry on normal activity; minor signs or symptoms of disease. 80 - Normal activity with effort; some signs or symptoms of disease. 70 - Cares for self; unable to carry on normal activity or to do active work. 60 - Requires occasional assistance, but is able to care for most of his personal needs.
50 - Requires considerable assistance and frequent medical care. 40 - Disabled; requires special care and assistance. 30 - Severely disabled; hospital admission is indicated although death not imminent.
20 - Very sick; hospital admission necessary; active supportive treatment necessary.
10 - Moribund; fatal processes progressing rapidly. 0 - Dead"|46 weeks|Analysis is of persons alive at the time point.||Scores on a scale||Standard Deviation|Mean
812896|NCT01075152|Secondary|Antiretroviral Therapy Tolerability|Incidence of antiretroviral therapy interruption by >=3 consecutive days|26 weeks|Analysis is of persons who survived to initiate HIV therapy.||participants|||Number
812897|NCT01075152|Secondary|HIV-1 Viral Suppression|HIV-1 virologic suppression to <400 copies/mL at 26-weeks after enrollment|26 weeks|Among persons alive at 26 weeks. 1 participant in the early ART arm had consent withdrawn by their family on day 2 after study entry. 3 participants in the deferred ART arm missing their 26 week viral load sampling.||participants|||Number
812898|NCT01075152|Secondary|46-week Survival|46-week survival by time-to-event analysis of all subjects enrolled|46 weeks|||participants|||Number
812899|NCT01075152|Secondary|Safety of ART Initiation|Incidence of Adverse Events (Grade 3,4,5) through 46-weeks, as defined by the National Institute of Allergy and Infectious Diseases, Division of AIDS toxicity classification scale, version 2009.|46 weeks|||participants|||Number
812900|NCT01075152|Secondary|Incidence of Cryptococcal-relapse|Incidence of culture positive cryptococcal meningitis relapse|46 weeks|||participants|||Number
812901|NCT01075152|Secondary|Incidence of Immune Reconstitution Inflammatory Syndrome|Incidence of cryptococcal-related immune reconstitution inflammatory syndrome through 46 weeks after enrollment.|46 weeks|analysis is of persons who survived to initiate HIV therapy||participants|||Number
812902|NCT01075152|Primary|Mortality|Intention to treat analysis of 26 week survival of all subjects enrolled. Reported below are the numbers of participants who died by Week 26.|26 weeks from study entry|||participants|||Number
812903|NCT01075178|Primary|Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Death|The number of subjects who died|8-month chart review period in CASES and CONTROLS|The population analyzed included the full analysis set.||participants|||Number
812904|NCT01075178|Primary|Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Serious Arrhythmia|The number of subjects who experienced at least 1 event of arrhythmia meeting any of the criteria for a serious adverse event|8-month chart review period in CASES and CONTROLS|The population analyzed included the full analysis set.||participants|||Number
812905|NCT01075178|Primary|Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Serious Infection.|The number of subjects who experienced at least 1 event of infection meeting any of the criteria for a serious adverse event|8-month chart review period in CASES and CONTROLS|The population analyzed included the full analysis set.||participants|||Number
812906|NCT01075178|Primary|Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Serious Infection, Serious Arrhythmia and/or Death|The number of subjects who experienced at least 1 event of infection, arrhythmia, or death meeting any of the criteria for a serious adverse event|8-month chart review period in CASES and CONTROLS|The population analyzed included the full analysis set.||participants|||Number
812907|NCT01075191|Secondary|Change From Baseline in CD4/CD8 T-cell Ratio|The CD4/CD8 T-cell ratio, also known as the T-lymphocyte helper/suppressor profile, presents the number of lymphocytes in the blood positive for CD4 cells compared with the number positive for CD8 cells. Changes in participants' CD4/CD8 T-lymphocyte ratio were assessed by measuring the change from Baseline in the ratio at scheduled study visits.|Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144|Evaluable participants. n=number of evaluable participants with given measurement at time point.||ratio||Standard Deviation|Mean
812908|NCT01075191|Secondary|Change From Baseline in Relative CD8 Cell Count|Decreases in relative CD8 count (the percentage of total lymphocytes that are CD8 cells) are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD8-positive (CD8+) T-lymphocyte counts were assessed by measuring the change from Baseline in the percentage of CD8+ cells at scheduled study visits.|Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144|Evaluable participants. n=number of evaluable participants with given measurement at time point.||percentage of cells||Standard Deviation|Mean
812909|NCT01075191|Secondary|Change From Baseline in Absolute CD8 Cell Count|Decreases in CD8 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD8-positive (CD8+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD8+ cells at scheduled study visits.|Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144|Evaluable participants. n=number of evaluable participants with given measurement at time point.||cells/µL||Standard Deviation|Mean
812910|NCT01075191|Secondary|Change From Baseline in Relative CD4 Cell Count|Increases in relative CD4 count (the percentage of total lymphocytes that are CD4 cells) are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the percentage of CD4+ cells at scheduled study visits.|Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144|Evaluable participants. n=number of evaluable participants with given measurement at time point.||percentage of cells||Standard Deviation|Mean
812911|NCT01075191|Secondary|Change From Baseline in Absolute CD4 Cell Count|Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.|Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144|Evaluable participants. n=number of evaluable participants with given measurement at time point.||cells/µL||Standard Deviation|Mean
814051|NCT01083758|Primary|Change in Albumincorrected Serum Calcium From Baseline (SV2) to Week 4, Week 8, and End of Treatment.|Change in albumincorrected serum calcium from Baseline (SV2 = screening visit 2) to Week 4, Week 8, and end of treatment.|Baseline and end of treatment (up to 8 weeks)|||mmol/L||Standard Deviation|Mean
812912|NCT01075191|Primary|Percentage of Participants With Human Immunodeficiency Virus -1 Ribonucleic Acid (HIV-1 RNA) <50 Copies/mL|Viral load (number of HIV-1 RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments. The percentage of participants with HIV RNA less than 50 copies/mL at each time point is presented.|Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144|Evaluable participants. n=number of evaluable participants with given measurement at time point.||percentage of participants|||Number
812913|NCT01075204|Secondary|Percentage of Participants Compliant With Treatment|Treatment compliance was assessed by the study physician at each study visit. The percentage of participants who were compliant with study treatment for 6 days, 7 days and 8 days is reported.|10 days|All enrolled patients.||percentage of participants|||Number
812914|NCT01075204|Secondary|Post-nasal Discharge Status at End of Study|Participants with post-nasal discharge at any time during the study were classified at the end of study as resolved, improved, or no change. 'No post-nasal discharge' indicates participants with no post-nasal discharge symptoms during the study period.|10 days|Enrolled patients with post-nasal discharge data available.||participants|||Number
812915|NCT01075204|Secondary|Rhinorrhea Status at End of Study|Participants with rhinorrhea (runny nose) at any time during the study were classified at the end of study as resolved, or no change. 'No rhinorrhea' indicates participants with no rhinorrhea during the study period.|10 days|All enrolled patients||participants|||Number
812916|NCT01075204|Secondary|Abnormal Breathing Sounds Status at End of Study|Participants with abnormal breathing sounds such as wheezing or rales at any time during the study were classified at the end of study as resolved, improved, or no change. 'No abnormal breath sounds' indicates participants with no abnormal breathing sounds during the study period.|10 days|All enrolled patients||participants|||Number
812917|NCT01075204|Secondary|Dyspnea Status at End of Study|Participants with dyspnea (shortness of breath) at any time during the study were classified at the end of study as resolved, improved, became worse, or no change. 'No dyspnea' indicates participants with no dyspnea symptoms during the study period.|10 days|All enrolled patients||participants|||Number
812918|NCT01075204|Secondary|Sputum Status at End of Study|Participants with sputum symptoms at any time during the study were classified at the end of study as resolved, improved, became worse, or no change. 'No sputum' indicates participants with no sputum symptoms during the study period.|10 days|Enrolled patients with sputum data available.||participants|||Number
812919|NCT01075204|Secondary|Cough Status at End of Study|Participants with cough at any time during the study were classified at the end of study as resolved, improved, became worse, or no change. 'No cough' indicates participants with no cough symptoms during the study period.|10 days|Enrolled patients with cough data available.||participants|||Number
812920|NCT01075204|Secondary|Fever Status at End of Study|Participants with fever (temperature over 37.0 degree of Celsius) at any time during the study were classified at the end of study as resolved, improved or no change. 'No fever' indicates participants with no fever during the study period.|10 days|All enrolled patients||participants|||Number
812921|NCT01075204|Primary|Classification of Overall Response|"Based on the participant and physician's assessment, overall symptom response was classified as follows:
Fast Responders: participants showing clinical recovery of all symptoms within the first 5 days of treatment.
Slow Responders: participants showing clinical recovery between Day 6 & Day 10 (includes participants with a fast response for some symptoms and slow response for the remaining symptoms).
Failure response: participants showing no clinical success by Day 10, or showing need for another anti-infective treatment to resolve aggravated symptoms (includes participants with a failure response for some symptoms and either a slow or fast response for the remaining symptoms)."|10 days|All enrolled patients||participants|||Number
812922|NCT01075204|Primary|Percentage of Participants With Clinical Success|Clinical success is defined as the disappearance of cough and other symptoms within 10 days or less from the start of clarithromycin treatment.|10 days|All enrolled patients.||percentage of participants||95% Confidence Interval|Number
812923|NCT01075204|Secondary|Number of Participants With Adverse Events|"An adverse event (AE) is defined as any untoward medical occurrence in a patient, which does not necessarily have a causal relationship with their treatment.
If an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE):
Results in death or is life-threatening, results in admission or prolongation of hospitalization, is a congenital anomaly or persistent or significant disability/incapacity or is an important medical event requiring medical or surgical intervention to prevent any of the outcomes listed above.
Please see Adverse Events section below for more details."|10 days|All enrolled patients.||participants|||Number
812924|NCT01075204|Secondary|Factors Affecting the Speed of Recovery|Factors affecting the speed of recovery were examined and tested for association with the speed of recovery. Logistic regression was conducted to assess whether the following nine variables; age, gender, body mass index (BMI), concomitant tobacco use, steroid use, bronchial asthma, allergic rhinitis, nasal septum deviation and chronic obstructive pulmonary disease (COPD) act as predictors for speed of recovery of respiratory tract infections. Data shown are the beta regression coefficients for each variable.|10 days|All enrolled patients||coefficient|||Number
812925|NCT01075204|Secondary|Percentage of Participants With Treatment Failure|"Treatment failure is defined as failure to return to baseline symptom status (symptom status prior to the onset of the respiratory tract infection) within 10 days or the need for new treatments or medications during the first 10 days for persistence or aggravation of symptoms.
Participants with treatment failure were further categorized as:
All symptoms improved but not resolved within the study period;
Some symptoms improved and some resolved;
Some symptoms resolved or improved while other symptoms did not improve (unchanged);
Some symptoms resolved or improved while other symptoms became worse."|10 days|All enrolled patients||percentage of participants|||Number
812926|NCT01075204|Primary|Percentage of Participants With a Fast Recovery|"Fast recovery is defined as the resolution of symptoms within 5 days or less from the start of clarithromycin modified release treatment. Recovery is defined as returning to the symptom status prior to the onset of the respiratory tract infection, based on the participant and physician's assessment.
Data are reported for all symptoms taken together (all symptoms resolved within 5 days) and for each individual symptom."|Day 1 to Day 5|All enrolled participants. For the individual symptoms, N indicates the number of participants with that symptom at Baseline and with available recovery data.||percentage of participants|||Number
812927|NCT01075217|Secondary|The Number of Participants With Adequate Quality of Opacification Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA|"The Investigator assessed all study images obtained for each patient using a 2-point scale (1 = adequate quality; 2 = inadequate quality); assessment was independent of factors or problems relating to the underlying patient condition or the imaging parameters selected.
Results are provided for patients with adequate quality."|Immediately postdose|Patients who did not deviate from the planned protocol and had the corresponding endpoint evaluations available were included in the analysis.||participants|||Number
812928|NCT01075217|Secondary|The Number of Participants Requiring Repeat Injection(s) Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA.|The Investigator assessed the images and recorded the number of repeat power injections required due to motion artifacts for each participant.|Immediately postdose|Patients who did not deviate from the planned protocol and had the corresponding endpoint evaluations available were included in the analysis.||participants|||Number
812929|NCT01075217|Secondary|The Number of Participants With Significant Motion Artifacts (Scores of 3 or 4) Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA.|Using the following 5-point scale, the Investigator reviewed the images for motion artifact in vessels distal to the knee: 0 = None; 1 = Mild, not significant; 2 = Significant, but correctable; 3 = Degrades image quality; 4 = Images uninterpretable. Scores of 3 and 4 were counted as significant motion artifacts.|Immediately postdose|Patients who did not deviate from the planned protocol and had the corresponding endpoint evaluations available were included in the analysis. Patients with significant motion artifact were those with a score of 3 or 4 for motion artifacts in vessels distal to the knee||participants|||Number
812930|NCT01075217|Secondary|Level of Heat in the Lower Extremities Scored by Group 2 as Assessed on the Heat VAS Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA|"The 10-centimeter Heat VAS was completed by the Group 2 patients to assess his/her heat level (separately from pain) in the lower extremity of interest. The scale was 0 to 10 cm, with the left end (0 cm)of the scale indicating no heat and the right end (10 cm) of the scale indicating the worst heat.
The Heat VAS was completed by the patient before completing the Pain VAS to assess pain."|Immediately after administration of agent using a power injector for the administration|Patients who did not deviate from the planned protocol and had the corresponding endpoint evaluations available were included in the analysis. Group 2 patients provided an assessment of heat by the Heat VAS prior to assessing pain by the Pain VAS.||centimeters||Standard Deviation|Mean
812931|NCT01075217|Primary|Level of Pain/Heat in the Lower Extremities Scored by the Participants on the Visual Analog Scale (VAS) Following Intra-arterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA|"The 10-centimeter Pain VAS was completed by the Group 1 patients to assess his/her pain level (not scoring heat separately from pain) in the lower extremity of interest. The scale was 0 to 10 cm, with the left end (0 cm)of the scale indicating no pain and the right end (10 cm) of the scale indicating the worst pain.
The 10-centimeter Pain VAS (excluding Heat assessment, which was separately assessed) was completed by the Group 2 patients to assess his/her pain level in the lower extremity of interest. The scale was 0 to 10 cm, with the left end (0 cm)of the scale indicating no pain and the right end (10 cm) of the scale indicating the worst pain.
Group 1 completed the Pain VAS (heat not separate from pain). Group 2 completed the Pain VAS for pain only and, separately, the Heat VAS for heat only."|immediately after administration of agent using a power injector for the administration|Patients who received study agent, had the corresponding endpoint evaluations available and had no deviations from the planned protocol were included in the analysis.||centimeters||Standard Deviation|Mean
812932|NCT01075243|Secondary|Participants Global Assessment to Response to Treatment (PGART)|PGART was measured by a score in a scale from 0-4: 0- Poor; 1- Fair 2- Good; 3- Very Good; 4- Excellent.|Baseline to 6 hours post dose|ITT population: All participants who received study treatment and had at least one post-baseline efficacy assessment.||Score on a scale||Standard Deviation|Mean
812933|NCT01075243|Secondary|SPID Scores at 6 Hours|"SPID was calculated as sum of products of Pain Intensity Differences (PID) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240, 240-300 and 300-360. Positive and higher scores indicate greater reduction in pain.
SPIDt = ∑PID x (timet - timet-1)
Pain Intensity was assessed at baseline and at each time-point based on a 4-point categorical Verbal Rating Scale (VRS) scale: 0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain.
If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from pain scores taken at baseline."|Every two hours from baseline to 6 hours post dose|ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes.||Score on a scale||Standard Deviation|Mean
812934|NCT01075243|Secondary|SPID Scores at 4 Hours|"SPID was calculated as sum of products of Pain Intensity Differences (PID) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240. Positive and higher scores indicate greater reduction in pain.
SPIDt = ∑PID x (timet - timet-1)
Pain Intensity was assessed at baseline and at each time-point based on a 4-point categorical Verbal Rating Scale (VRS) scale: 0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain.
If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from pain scores taken at baseline."|Every two hours from baseline to 4 hours post dose|ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes.||Score on a scale||Standard Deviation|Mean
812942|NCT01075243|Secondary|Percentage of Participants Who Took Rescue Medication at 2 Hours|Percentage of participants who received rescue medication at different time points post dose.|Baseline to 2 hours post dose|ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes.||Percentage of participants|||Number
812935|NCT01075243|Secondary|Sum of Pain Intensity Difference (SPID) Scores at 2 Hours|"SPID was calculated as sum of products of Pain Intensity Differences (PID) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120. Positive and higher scores indicate greater reduction in pain.
SPIDt = ∑PID x (timet - timet-1)
Pain Intensity was assessed at baseline and at each time-point based on a 4-point categorical Verbal Rating Scale (VRS) scale: 0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain.
If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from pain scores taken at baseline."|Every two hours from baseline to 2 hours post dose|ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes.||Score on a scale||Standard Deviation|Mean
812936|NCT01075243|Secondary|TOTPAR at 6 Hours|"TOTPAR was calculated as sum of products of pain relief (PR) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240, 240-300 and 300-360. Higher score indicated greater pain relief.
TOTPARt = ∑PR x (timet – timet-1).
PR score was assessed at each of the above time-points based on a 5-point categorical scale [0-no relief, 1-little relief, 2-meaningful relief, 3-a lot of relief, 4-complete relief]."|Every two hours from baseline to 6 hours post dose|ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes.||Score on a scale||Standard Deviation|Mean
812937|NCT01075243|Secondary|TOTPAR at 4 Hours|"TOTPAR was calculated as sum of products of pain relief (PR) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240. Higher score indicated greater pain relief.
TOTPARt = ∑PR x (timet – timet-1).
PR score was assessed at each of the above time-points based on a 5-point categorical scale [0-no relief, 1-little relief, 2-meaningful relief, 3-a lot of relief, 4-complete relief]."|Every two hours from baseline to 4 hours post dose|ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes.||Score on a scale||Standard Deviation|Mean
812938|NCT01075243|Secondary|Total Pain Relief Score (TOTPAR) at 2 Hours|"TOTPAR was calculated as sum of products of pain relief (PR) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120. Higher score indicated greater pain relief.
TOTPARt = ∑PR x (timet – timet-1).
PR score was assessed at each of the above time-points based on a 5-point categorical scale [0-no relief, 1-little relief, 2-meaningful relief, 3-a lot of relief, 4-complete relief]."|Every two hours from baseline to 2 hours post dose|ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes.||Score on a scale||Standard Deviation|Mean
812939|NCT01075243|Secondary|SPRID at 4 Hours|SPRID:Sum of Pain Intensity Difference (SPID) and Total Pain Relief (TOTPAR) at each post-dosing time-point. SPRID score ranged from -3.8 (least pain relief) to 26.3 (highest pain relief). SPID and TOTPAR were calculated as weighted sums of Pain Intensity Differences (PID) and Pain Relief Scores (PRS) at each measurement time, respectively. PID was derived by subtracting the pain severity score at a given post-dosing time-point from the baseline [pain severity score range:0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain using a 4-point categorical Verbal Rating Scale (VRS)]. If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from baseline pain scores. PRS was assessed on 5-point categorical pain relief rating scale [0-no relief, 1-little relief, 2-some relief, 3-a lot of relief, 4-complete relief|Every two hours from baseline to 4 hours post dose|ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes.||Score on a scale||Standard Deviation|Mean
812940|NCT01075243|Secondary|SPRID at 2 Hours|SPRID:Sum of Pain Intensity Difference (SPID) and Total Pain Relief (TOTPAR) at each post-dosing time-point. SPRID score ranged from -1.8 (least pain relief) to 12.3 (highest pain relief). SPID and TOTPAR were calculated as weighted sums of Pain Intensity Differences (PID) and Pain Relief Scores (PRS) at each measurement time, respectively. PID was derived by subtracting the pain severity score at a given post-dosing time-point from the baseline [pain severity score range:0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain using a 4-point categorical Verbal Rating Scale (VRS)]. If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from baseline pain scores. PRS was assessed on 5-point categorical pain relief rating scale [0-no relief, 1-little relief, 2-some relief, 3-a lot of relief, 4-complete relief|Every two hours from baseline to 2 hours post dose|All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes.||Score on a scale||Standard Deviation|Mean
812941|NCT01075243|Secondary|Percentage of Participants Who Took Rescue Medication at 6 Hours|Percentage of participants who received rescue medication at different time points post dose.|Baseline to 6 hours post dose|ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes.||Percentage of participants|||Number
812943|NCT01075243|Secondary|Time to Start Using Rescue Medication|Median time of use of rescue medication by participants.|Baseline to 6 hours post dose|ITT population: All participants who received one study treatment and had at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored.||minutes||Full Range|Median
812944|NCT01075243|Secondary|Time to Onset of Meaningful Pain Relief|Participants recorded the time to meaningful relief by stopping a second stopwatch when they first began to experience meaningful relief.|Baseline to 6 hours post dose|ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes.||minutes||Standard Deviation|Mean
812945|NCT01075243|Secondary|Time to Confirmed First Perceptible Relief|Participants recorded the time to first perceptible relief by starting the first stopwatch at the time of dosing and stopping it when he/she experienced the first perceptible pain relief. The first perceptible pain relief was confirmed if the participant also stopped the second stopwatch indicating meaningful relief.|Baseline to 6 hours post dose|ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes.||minutes||Standard Deviation|Mean
812946|NCT01075243|Primary|Sum of Pain Relief and Pain Intensity Differences From 0 to 6 Hours (SPRID 6 Hours)|SPRID:Sum of Pain Intensity Difference (SPID) and Total Pain Relief (TOTPAR) at each post-dosing time-point. SPRID score ranged from -5.8 (least pain relief) to 40.3 (highest pain relief). SPID and TOTPAR were calculated as weighted sums of Pain Intensity Differences (PID) and Pain Relief Scores (PRS) at each measurement time, respectively. PID was derived by subtracting the pain severity score at a given post-dosing time-point from the baseline [pain severity score range:0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain using a 4-point categorical Verbal Rating Scale (VRS)]. If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from baseline pain scores. PRS was assessed on 5-point categorical pain relief rating scale [0-no relief, 1-little relief, 2-some relief, 3-a lot of relief, 4-complete relief]|Every two hours from Baseline to 6 hours post dose|Intent to Treat (ITT) population: All participants who received one study treatment and have at least one post-baseline efficacy assessment.||Score on a scale||Standard Deviation|Mean
812947|NCT01075256|Other Pre-specified|Adjusted Mean Change From Baseline in Cold Water Sensitivity Pain Response on a VAS at Day 3|Response of exposed dentine surface to application of 1 ml freshly melted ice cold water was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.|Baseline to Day 3|ITT population subset: A subset of randomized participants who received at least one dose of investigational product who have at least one post-baseline efficacy measure. Missing data was not imputed. Due to drop outs, there was difference in number of participants analyzed.||Units on a scale||95% Confidence Interval|Mean
812948|NCT01075256|Other Pre-specified|Adjusted Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a VAS at Day 3|Response to a constant jet of air applied to a hypersensitive tooth was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.|Baseline to Day 3|ITT population subset: A subset of randomized participants who received at least one dose of investigational product who have at least one post-baseline efficacy measure. Missing data was not imputed. Due to drop outs, there was difference in number of participants analyzed.||Units on a scale||95% Confidence Interval|Mean
812949|NCT01075256|Other Pre-specified|Adjusted Mean Change From Baseline in Cold Water Sensitivity Pain Response on a VAS at Day 10|Response of exposed dentine surface to application of 1 ml freshly melted ice cold water was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.|Baseline to Day 10|ITT population subset: A subset of randomized participants who received at least one dose of investigational product who have at least one post-baseline efficacy measure. Missing data was not imputed. Due to drop outs, there was difference in number of participants analyzed.||Units on a scale||95% Confidence Interval|Mean
812950|NCT01075256|Other Pre-specified|Adjusted Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a VAS at Day 10|Response to a constant jet of air applied to a hypersensitive tooth was evaluated using a 100mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.|Baseline to Day 10|ITT population subset: A subset of randomized participants who received at least one dose of investigational product who have at least one post-baseline efficacy measure. Missing data was not imputed. Due to drop outs, there was difference in number of participants analyzed.||Units on a scale||95% Confidence Interval|Mean
812951|NCT01075256|Secondary|Adjusted Mean Change From Baseline in Cold Water Sensitivity Pain Response on a VAS at Day 7|Response of exposed dentine surface to application of 1 ml freshly melted ice cold water was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.|Baseline to Day 7|ITT population: All randomized participants who received at least one dose of investigational product who have at least one post-baseline efficacy measure. Missing data was not imputed. Due to drop outs, there was difference in number of participants analyzed.||Units on a scale||95% Confidence Interval|Mean
812961|NCT01075282|Secondary|Change From Baseline to 26, 52 and 78 Weeks on Serum Calcitonin||Baseline, 26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable serum calcitonin data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||picogram/milliliter||Standard Deviation|Mean
831861|NCT01243320|Secondary|Mean Change in Heart Rate|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days|||bpm||95% Confidence Interval|Mean
812952|NCT01075256|Primary|Adjusted Mean Change From Baseline in Cold Water Sensitivity Pain Response on a VAS at Day 15|Response of exposed dentine surface to application of 1 ml freshly melted ice cold water was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.|Baseline to Day 15|ITT population: All randomized participants who received at least one dose of investigational product who have at least one post-baseline efficacy measure. Missing data was not imputed. Due to drop outs, there was difference in number of participants analyzed.||Units on a scale||95% Confidence Interval|Mean
812953|NCT01075256|Secondary|Adjusted Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a VAS at Day 7|Response to a constant jet of air applied to a hypersensitive tooth was evaluated using a 100 millimeter (mm) VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.|Baseline to Day 7|ITT population: All randomized participants who received at least one dose of investigational product who have at least one post-baseline efficacy measure. Missing data was not imputed. Due to drop outs, there was difference in number of participants analyzed.||Units on a scale||95% Confidence Interval|Mean
812954|NCT01075256|Primary|Adjusted Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a Visual Analog Scale (VAS) at Day 15|Response to a constant jet of air applied to a hypersensitive tooth was evaluated using a 100 millimeter (mm) VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.|Baseline to Day 15|Intention to treat (ITT) population: All randomized participants who received at least one dose of investigational product who have at least one post-baseline efficacy measure. Missing data was not imputed. Due to drop outs, there was difference in number of participants analyzed.||Units on a scale||95% Confidence Interval|Mean
812955|NCT01075282|Secondary|Number of Participants With LY2189265 Antibodies at 26, 52, 78 Weeks and 4 Weeks After Last Dose of Study Drug (83 Weeks Maximum)|LY2189265 (Dulaglutide) anti-drug antibodies (ADA) were assessed at baseline, 26, 52, and 78 weeks, and at the safety follow-up visit 30 days after study drug discontinuation (83 weeks). The number of participants with initial postbaseline detection of treatment emergent (defined as a 4-fold increase in the ADA titer from baseline) LY2189265 ADA at each time point were summarized.|Baseline, 26, 52, 78, and 83 weeks|Participants who received at least one dose of LY2189265 with evaluable LY2189265 ADA data.||participants|||Number
812956|NCT01075282|Secondary|Change From Baseline to 26, 52 and 78 Weeks on Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. PR is the interval between the P wave and the QRS complex. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable ECG QTcF or PR Interval data.||milliseconds (msec)||Standard Error|Least Squares Mean
812957|NCT01075282|Secondary|Change From Baseline to 26, 52 and 78 Weeks on Electrocardiogram Parameters, Heart Rate|Electrocardiogram (ECG) heart rate was measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable ECG heart rate data.||beats per minute (bpm)||Standard Error|Least Squares Mean
812958|NCT01075282|Secondary|Change From Baseline to 26, 52, and 78 Weeks on Blood Pressure|Sitting systolic blood pressure (SBP) and sitting diastolic blood pressure (DBP) were measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable blood pressure data.||milliliter of mercury (mmHG)||Standard Error|Least Squares Mean
812959|NCT01075282|Secondary|Change in Baseline to 26, 52 and 78 Weeks on Pulse Rate|Sitting pulse rate was measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable sitting pulse rate data.||beats per minute (bpm)||Standard Error|Least Squares Mean
812960|NCT01075282|Secondary|Number of Participants With Adjudicated Cardiovascular Events at 26, 52 and 78 Weeks|Information on cardiovascular (CV) risk factors was collected at baseline. Data on any new CV event was prospectively collected using a CV event electronic case report form. At prespecified visits, participants were asked about any new CV event. Deaths and nonfatal cardiovascular adverse events (AEs) were adjudicated by a committee of physicians with cardiology expertise external to the Sponsor. The nonfatal cardiovascular AEs to be adjudicated include myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions (such as coronary artery bypass graft or percutaneous coronary intervention), and cerebrovascular events including cerebrovascular accident (stroke) and transient ischemic attack. The number of participants with adjudicated CV events is summarized cumulatively at 26, 52, and 78 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine.||participants|||Number
814961|NCT01092663|Primary|Fasting Plasma Glucose Clearance|Change from baseline in fasting plasma glucose clearance after 12 weeks of colesevelam alone or colesevelam plus sitagliptin treatments.|baseline and 12 weeks|||ml per kg FFM per minute (min)||Standard Deviation|Mean
812962|NCT01075282|Secondary|Number of Participants With Adjudicated Pancreatitis at 26, 52 and 78 Weeks|The number of participants with pancreatitis confirmed by adjudication is summarized cumulatively at 26, 52, and 78 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine.||participants|||Number
812963|NCT01075282|Secondary|Change From Baseline to 26, 52 and 78 Weeks on Pancreatic Enzymes|Amylase (total and pancreas-derived) and lipase concentrations were measured.|Baseline, 26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable pancreatic enzyme data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||units/liter||Inter-Quartile Range|Median
812964|NCT01075282|Secondary|Number of Participants Requiring Additional Intervention Due to Hyperglycemia at 26, 52 and 78 Weeks|Additional intervention was defined as any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation. The number of participants requiring additional intervention due to hyperglycemia is summarized cumulatively at 26, 52, and 78 weeks.|26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine.||participants|||Number
812965|NCT01075282|Secondary|Rate of Self-reported Hypoglycemic Events at 26, 52 and 78 Weeks|Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of =<3.9 mmol/L), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of =<3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The 1-year adjusted rate of hypoglycemic events is summarized cumulatively at 26, 52, and 78 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine.||events per participant per year||Standard Deviation|Mean
812966|NCT01075282|Secondary|Number of Self-reported Hypoglycemic Events at 26, 52 and 78 Weeks|Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of =<3.9 mmol/L), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of =<3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The number of self-reported hypoglycemic events is summarized cumulatively at 26, 52, and 78 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine.||events|||Number
812967|NCT01075282|Secondary|Number of Participants With Treatment Emergent Adverse Events at 26, 52 and 78 Weeks|A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with one or more TEAE is summarized cumulatively at 26, 52, and 78 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine. The number of participants with at least 1 TEAE is reported.||participants|||Number
812968|NCT01075282|Secondary|Change From Baseline to 26, 52 and 78 Weeks in the Low Blood Sugar Survey|The Low Blood Sugar Survey (LBSS) contains 33 items comprised of 2 subscales (behavior and worry), each of which is rated on a 5-point numeric rating scale from 0 (never) to 4 (almost always). It captures behavioral changes associated with the concerns and experiences of hypoglycemia and the degree to which participants are worried about certain aspects associated with hypoglycemia during the previous 4 weeks. The behavior (or avoidance) subscale has 15 items, and the worry (or affect) subscale has 18 items. Subscale scores are calculated by summing participant responses to items (behavior range 0-60; worry range 0-72). A total score is calculated as the sum of both subscales (range 0-132). Higher scores indicate greater negative impact on subscales and total score. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate.|Baseline, 26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable LBSS data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||units on a scale||Standard Error|Least Squares Mean
812969|NCT01075282|Secondary|Change From Baseline to 26, 52 and 78 Weeks in the Impact of Weight on Self-Perception|The Impact of Weight on Self-Perception (IW-SP) questionnaire contains 3 items that assess how often the participants' body weight affects how happy they are with their appearance and how often they feel self-conscious when out in public. Items are scored on a 5-point numeric rating scale where 5 = never and 1 = always. A single total score is calculated by summing the scores for all 3 items. Total score ranges between 3 and 15, where a higher score is indicative of better self-perception. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate.|Baseline, 26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable IW-SP data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||units on a scale||Standard Error|Least Squares Mean
831862|NCT01243320|Secondary|Mean Change in Diastolic Blood Pressure|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days|||mmhg||95% Confidence Interval|Mean
812970|NCT01075282|Secondary|Change From Baseline to 26, 52 and 78 Weeks in the Impact of Weight on Activities of Daily Living|The Impact of Weight on Activities of Daily Living questionnaire (renamed the Ability to Perform Physical Activities of Daily Living Questionnaire [APPADL]) contains 7 items that assess how difficult it is for participants to engage in certain activities considered to be integral to normal daily life, such as walking, standing and climbing stairs. Items are scored on a 5-point numeric rating scale where 5 = “not at all difficult” and 1 = “unable to do”. The individual scores from all 7 items are summed and a single total score is calculated and may range between 7 and 35. A higher score indicates better ability to perform activities of daily living. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate.|Baseline, 26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable APPADL data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||units on a scale||Standard Error|Least Squares Mean
812971|NCT01075282|Secondary|Change From Baseline to 26, 52 and 78 Weeks in the EuroQol 5 Dimension|The European Quality of Life - 5 dimensions (EQ-5D) questionnaire is a generic, multidimensional, health-related, quality-of-life instrument. It consists of 2 parts: the first part assesses 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that have 3 possible levels of response (no problem, some problem, or extreme problem). These dimensions are converted into a weighted health-state Index Score. The EQ-5D United Kingdom (UK) score ranges from -0.59 to 1.0, where a score of 1.0 indicates perfect health and negative values are valued as worse than dead. The second part of the questionnaire consists of a 100-mm visual analog scale (VAS) on which the participants rated their perceived health state on that day from 0 (worst imaginable health state) to 100 (best imaginable health). Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) and adjusted by treatment, country, and baseline.|Baseline, 26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable EQ-5D data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||units on a scale||Standard Error|Least Squares Mean
812972|NCT01075282|Secondary|Change From Baseline to 26, 52 and 78 Weeks for Body Mass Index|Body mass index (BMI) is an estimate of body fat based on body weight divided by height squared. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable BMI data.||kilograms per square meter (kg/m^2)||Standard Error|Least Squares Mean
812973|NCT01075282|Secondary|Change From Baseline to 26, 52 and 78 Weeks for Body Weight|Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate.|Baseline, 26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable body weight data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||kilogram (kg)||Standard Error|Least Squares Mean
812974|NCT01075282|Secondary|Change From Baseline to 52 and 78 Weeks in Glucagon Concentration|Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate.|Baseline, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable glucagon data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||picomoles per liter (pmol/L)||Standard Error|Least Squares Mean
812975|NCT01075282|Secondary|Change From Baseline to 52 and 78 Weeks in Updated Homeostasis Model Assessment of Beta-cell Function (HOMA2-%B) and Updated Homeostasis Model Assessment of Insulin Sensitivity (HOMA2-%S)|The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance and beta (β)-cell function. HOMA2-B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state beta cell function (%B) as a percentage of a normal reference population (normal young adults). HOMA2-S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S), as percentages of a normal reference population (normal young adults). The normal reference population for both HOMA2-B and HOMA-2S were set at 100%. Least Squares (LS) means of change from baseline of C-peptide based HOMA2-%B and HOMA2-%S were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 with evaluable HOMA2-%B or HOMA2-%S data. Only pre-rescue measurements were used.||percentage of HOMA2||Standard Error|Least Squares Mean
812976|NCT01075282|Secondary|Change From Baseline to 26, 52 and 78 Weeks for Daily Mean Blood Glucose Values From the 8-point Self-monitored Blood Glucose (SMBG) Profiles|The self-monitored blood glucose (SMBG) data were collected at the following 8 time points: pre-morning meal; 2 hours post-morning meal; pre-midday meal; 2 hours post-midday meal; pre-evening meal; 2 hours post-evening meal; bedtime; and 3 AM or 5 hours after bedtime. Least Squares (LS) means of the mean of the 8 time points (Daily Mean) were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable SMBG data. Only pre-rescue measurements were used.||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
812994|NCT01075763|Secondary|Global Deterioration Scale Score|Global deterioration scale includes seven different diagnostic stages ranging between “no cognitive deterioration” and “very serious cognitive deterioration”. It investigates the cognitive impairment. Scores range between 1 (no cognitive deterioration) and 7 (very severe cognitive decline).|Baseline, Week 28 and 52|Per protocol population included all participants who received treatments as scheduled and were followed up to week 52.||units on a scale||Standard Deviation|Mean
812977|NCT01075282|Secondary|Number of Participants Achieving Glycosylated Hemoglobin (HbA1c) Less Than or Equal to 6.5% at 26, 52 and 78 Weeks|Number of participants achieving HbA1c levels less than or equal to 6.5% was analyzed with a logistic regression model with baseline, country, and treatment as factors included in the model.|26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable HbA1c data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||participants|||Number
812978|NCT01075282|Secondary|Number of Participants Achieving Glycosylated Hemoglobin (HbA1c) Less Than 7% at 26, 52 and 78 Weeks|Number of participants achieving HbA1c levels less than 7.0% was analyzed with a logistic regression model with baseline, country, and treatment as factors included in the model.|26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable HbA1c data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||participants|||Number
812979|NCT01075282|Secondary|Change From Baseline to 26 Weeks and 78 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c)|Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline HbA1c as a covariate.|Baseline, 26 weeks, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable HbA1c data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||percent||Standard Error|Least Squares Mean
812980|NCT01075282|Primary|Change From Baseline to 52 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c)|Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline HbA1c as a covariate.|Baseline, 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable HbA1c data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
812981|NCT01075347|Secondary|Patients With Corneal Complications Due to Delayed Surface Re-epithelization (e.g. Infectious Corneal Ulcer, Corneal Melting, Sterile Corneal Ulcer, Corneal Neovascularization)||every day till total re-epithelization up to 14 days|||participants|||Number
812982|NCT01075347|Primary|Patients With Corneal Epithelial Healing Time Within 14 Days|Patients were hospitalized and examined daily for graft re-epithelialization, which was the main outcome measure.Corneal epithelial healing(the process which the new corneal epithelial cells regenerated to cover the bare cornea lost of its epithelium, the cornea's outer layer) was recorded daily by slit-lamp examination with fluorescein staining.Patients with post-operative chronic persistent epithelial defects for >14 days after the operation were treated with therapeutic contact lens (TCL) application and followed up as outpatients.|every day till total re-epithelization up to 14 days|||participants|||Number
812983|NCT01075399|Primary|Reproducibility of [F18]HX4 PET Imaging in Measuring Hypoxia in Tumors|Primary tumor uptake of [F 18]HX4 was measured on PET images by onsite radiologist or nuclear medicine physician for 1st and 2nd PET scans. Values measured were: SUV (Standard Uptake Value), SUV Max (Maximum standard uptake value), SUV Mean (Mean standard uptake value), and T/B ratio (Tumor to background ratio). Pearson's correlation coefficient was calculated for each of the parameter.|Time between 1st and 2nd scan was 1 to 6 days|Based upon inclusion/exclusion criteria||participants|||Number
812984|NCT01075646|Secondary|Contamination of the Catheter (Microbiologist Analysis)||at 48 hours|||participants|||Number
812985|NCT01075646|Secondary|Local Reaction in the Wound and Insertion Point of the Catheter (Inflammation Signs and Infection)||During 8-15 days|||participants|||Number
812986|NCT01075646|Secondary|Secondary Effects Due to Morphine: Nausea and Vomiting||during 48 hours|||participants|||Number
812987|NCT01075646|Secondary|Time Spent Sitting in a Chair, Deambulation, Solid Ingestion.||7 Days (from Day 8-15)|||hours||Inter-Quartile Range|Median
812988|NCT01075646|Secondary|Intensity of Pain Measured by Verbal Pain Scale.|Verbal pain scale is a numeric measure of intensity pain, values range from 0 (no pain) to 10 (excruciating pain), Each patient rate the paín that feel with a number from 0 to 10.|At interval periods during 48 hours|||units on a scale||Inter-Quartile Range|Median
812989|NCT01075646|Primary|Mg of Morphine Consumption During 48 Hours Administered by Patient Controlled Analgesia System||48 hours|||mg||Inter-Quartile Range|Median
812990|NCT01075685|Secondary|Change in the Number of Excessive Drinkers|The number of excessive drinkers is the number of participants whose weekly alcohol intake exceeds guidelines, i.e. 21 or 14 standard drinks (male/female) per week|baseline and 6 weeks|||participants|||Number
812991|NCT01075685|Secondary|Category of Change in Weekly Alcohol Intake|"Category of change in weekly alcohol intake (WAI) is a 3-level categorical variable whose values are:
clinically significant reduction in WAI, defined as a decrease of 10% or over;
clinically significant increase in WAI, defined as an increase of 10% or over if WAI at baseline is positive, or any increase if WAI at baseline is 0);
and no clinically significant change, which includes all other cases."|baseline and 6 weeks|||participants|||Number
812992|NCT01075685|Secondary|Relative Change in Weekly Alcohol Intake|(6 weeks minus baseline)/baseline|baseline and 6 weeks|Participants with weekly alcohol consumption baseline at 0 were excluded from this analysis||percent of baseline consumption||Standard Deviation|Mean
812993|NCT01075685|Primary|Change in Weekly Alcohol Intake|"The unit of standard drink is a drink containing 10g of pure alcohol. Participants had to report their weekly alcohol intake in a diary, in which they could choose among 21 glasses of various capacities and containing various alcoholic drinks. Each of those glasses was then converted into standard drinks."|baseline and 6 weeks|Only participants who completed the study were included in this analysis||standard drinks||Standard Deviation|Mean
813005|NCT01075815|Secondary|Number of Participants With Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|Baseline up to 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days])|Safety population included all participants who had received at least 1 dose of the study medication.||participants|||Number
812995|NCT01075763|Secondary|Geriatric Depression Scale (GDS) Score|The GDS consists of 30 'yes' or 'no' items aimed to assess depression. One point is assigned to each answer and the cumulative score is rated on a scoring grid. Scores are grouped as follows: 0-9 'normal', 10-19 'mildly depressed', and 20-30 'severely depressed'.|Baseline, Week 28 and 52|Per protocol population included all participants who received treatments as scheduled and were followed up to week 52.||units on a scale||Standard Deviation|Mean
812996|NCT01075763|Secondary|Clinician's Interview Based Impression of Change (CIBIC-PLUS) Score|CIBIC-PLUS: structured instrument based on comprehensive evaluation of 3 domains: participant cognition, behavior and functioning, including assessment of daily living activities. It includes 15 items and represents assessment of skilled clinician using validated scales based on the observation at interviews conducted separately with participant and caregiver familiar with behavior of participant. According to comparison between baseline and follow-up assessments, scores can range between 1 (markedly improved) and 7 (markedly worsened), with 4 indicating no change observed between two visits.|Week 28 and 52|Per protocol population included all participants who received treatments as scheduled and were followed up to week 52.||participants|||Number
812997|NCT01075763|Secondary|Physical Self-Maintenance Scale (PSMS) Score|PSMS designed as a disability measure for use in planning and evaluating treatment in elderly participants living in community or in institutions, is Guttman scale containing 6 items of self-care. The scale is based on theory that human behavior can be ordered in a hierarchy of complexity, within each category, a further hierarchy of complexity runs from basic to complex activities. It includes 6 items, testing the following areas: toilet use, eating, dressing, physical appearance, deambulation and bath. Scores range between 0 (excellent performance) and 30 (worst performance).|Baseline, Week 28 and 52|Per protocol population included all participants who received treatments as scheduled and were followed up to week 52.||units on a scale||Standard Deviation|Mean
812998|NCT01075763|Secondary|Instrumental Activities of Daily Living (IADL) Score|IADL is used to evaluate participants with early-stage disease, both to assess level of disease and to determine participant's ability of self-care. IADL scale measures functional impact of emotional, cognitive, and physical impairments. It provides information about participants' compromising rate and care he might need. It includes 8 items: testing ability to use telephone, shopping, food preparation, housekeeping, laundry, mode of transportation, responsibility for own medication and ability to handle finances. Scores range between 0 (impairment) and 8 (full independence).|Baseline, Week 28 and 52|Per protocol population included all participants who received treatments as scheduled and were followed up to week 52.||units on a scale||Standard Deviation|Mean
812999|NCT01075763|Secondary|Alzheimer's Disease Assessment Scale, Non-cognitive Subscale (ADAS-NonCog) Score|ADAS-NonCog is a subscale of ADAS aimed to evaluate the non-cognitive features such as mood state and behavioral changes. It takes about 10 minutes to be performed and includes 10 items: testing tearful, depressed mood, concentration/distractibility, uncooperative to testing, delusions, hallucinations, pacing, motor activity increase, tremors and appetite change. Scores range between 0 (excellent performance) and 35 (worst performance).|Baseline, Week 12, 28 and 52|Per protocol population included all participants who received treatments as scheduled and were followed up to week 52.||units on a scale||Standard Deviation|Mean
813000|NCT01075763|Secondary|Mini Mental Status Examination (MMSE) Score|MMSE is a tool for screening cognitive decline associated with dementia. It is a brief examination intended to evaluate an adult participant's level of cognitive functioning. The test is performed in following areas: orientation in time and place, learning and immediate recall, mental control and concentration, short-term recall, naming ability, language expression, verbal comprehension, writing comprehension, writing ability and visual-spatial coordination. Scores range between 0 (maximum cognitive deficit) and 30 (no cognitive deficit).|Baseline, Week 12, 28 and 52|Per protocol population included all participants who received treatments as scheduled and were followed up to week 52.||units on a scale||Standard Deviation|Mean
813001|NCT01075763|Secondary|Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-Cog) Score|ADAS: global rating scale created to evaluate both cognitive and functional aspects linked with disease progression. ADAS-Cog: subscale of ADAS which consists in a series of short tests aimed to evaluate possible cognitive impairment due to disease progression. It includes 11 items, testing word-finding difficulty, following commands, naming: objects and fingers, orientation, word recognition, recall of test instructions, constructions, ideational praxis, spoken language ability, comprehension of spoken language and word recall. Scores range from 0 (no impairment) to 70 (serious deficit).|Week 12 and 28|Per protocol population included all participants who received treatments as scheduled and were followed up to week 52.||units on a scale||Standard Deviation|Mean
813002|NCT01075763|Primary|Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-Cog) Score|ADAS: global rating scale created to evaluate both cognitive and functional aspects linked with disease progression. ADAS-Cog: subscale of ADAS which consists in a series of short tests aimed to evaluate possible cognitive impairment due to disease progression. It includes 11 items, testing word-finding difficulty, following commands, naming: objects and fingers, orientation, word recognition, recall of test instructions, constructions, ideational praxis, spoken language ability, comprehension of spoken language and word recall. Scores range from 0 (no impairment) to 70 (serious deficit).|Baseline and Week 52|Per protocol population included all participants who received treatments as scheduled and were followed up to week 52.||units on a scale||Standard Deviation|Mean
813003|NCT01075815|Secondary|Number of Cycles Cancelled Due to Risk of Ovarian Hyper Stimulation Syndrome (OHSS)|OHSS is a syndrome which can manifest with enlarged ovaries, advanced ascites with increased vascular permeability, pleural fluid accumulation, hemoconcentration, and increased blood clotting.|Baseline up to 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days])|Safety population included all participants who had received at least 1 dose of the study medication.||cycles|||Number
813004|NCT01075815|Secondary|Number of Participants With Ovarian Hyper Stimulation Syndrome (OHSS)|OHSS is a syndrome which can manifest with enlarged ovaries, advanced ascites with increased vascular permeability, pleural fluid accumulation, hemoconcentration, and increased blood clotting.|Baseline up to 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days])|Safety population included all participants who had received at least 1 dose of the study medication.||participants|||Number
814052|NCT01083758|Primary|Change in Albumincorrected Serum Calcium From Baseline (SV2) to Week 4, Week 8, and End of Treatment.|Change in albumincorrected serum calcium from Baseline (SV2 = screening visit 2) to Week 4, Week 8, and end of treatment.|Baseline and week 8|||mmol/L||Standard Deviation|Mean
813007|NCT01075815|Secondary|Number of Recombinant Human Choriogonadotropin (r-hCG) Cycles Cancelled Due to Poor Response|Poor response was defined as 3 or less follicles of greater than or equal to 12 mm developing following at least 7 days of study treatment.|Up to 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days])|ITT population included all randomized participants who had received at least 1 dose of the study medication.||cycles|||Number
813008|NCT01075815|Secondary|Number of Ovarian Stimulation Days|Ovarian stimulation included from first rFSH injection (S1) until day on which r-hCG was administered (r-hCG day). This period was divided into 2 parts: the first period in which 300 International Unit (IU) rFSH dose was constant and which covered from S1 to Day 4 of stimulation period (S4); the second period in which the rFSH dose could be adjusted depending on the ovarian response and which began on S4 and finished on the day on which the criteria for administration of r-hCG to induce the final follicular maturation were met.|S1 up to r-hCG day (end of stimulation cycle [approximately 28 days])|ITT population included all randomized participants who had received at least 1 dose of the study medication.||Days||Standard Deviation|Mean
813009|NCT01075815|Secondary|Estradiol (E2) Levels on r-hCG Day||r-hCG day (end of stimulation cycle [approximately 28 days])|"ITT population included all randomized participants who had received at least 1 dose of the study medication. Here N represents the number of participants with plasma E2 levels at r-hCG day."||picogram/milliter (pg/mL)||Standard Deviation|Mean
813010|NCT01075815|Secondary|Total Dose of Recombinant Follicle Stimulating Hormone (r-FSH)||2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days])|ITT population included all randomized participants who had received at least 1 dose of the study medication.||IU||Standard Deviation|Mean
813011|NCT01075815|Secondary|Number of Participants With Clinical Pregnancies|Clinical pregnancy was defined as pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It includes ectopic pregnancy.|2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days])|ITT population included all randomized participants who had received at least 1 dose of the study medication.||participants|||Number
813012|NCT01075815|Secondary|Number of Participants With Biochemical Pregnancies|Biochemical pregnancy was defined as a pregnancy diagnosed only by the detection of hCG in serum or urine and that does not develop into a clinical pregnancy.|2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days])|ITT population included all randomized participants who had received at least 1 dose of the study medication.||participants|||Number
813013|NCT01075815|Secondary|Number and Quality of Embryos|Embryos were graded according to Spanish Association for the Study of Reproductive Biology (ASEBIR) criteria into different categories: (A) optimal quality with maximum capacity for implantation, (B) good quality with a high capacity for implantation, (C) regular with low possibility of implantation and (D) poor quality with very little possibility of implantation.|Day 2-3 post OPU (34-38 hours post r-hCG day {end of stimulation cycle}[approximately 28 days])|"ITT population included all randomized participants who had received at least 1 dose of the study medication. Here N represents the number of participants who had at least one fertilized oocyte."||embyros|||Number
813014|NCT01075815|Secondary|Number of Fertilized Oocytes (2 Pronuclei [PN])|Oocytes were fertilized using Intra-cytoplasmic Sperm Injection (ICSI) technique which is an in-vitro fertilization procedure in which a single sperm is injected directly into an egg under a microscope. The appearance of two 2PN is the first sign of successful fertilization as observed during in vitro fertilization, and is usually observed after ICSI. The zygote is then termed 2PN.|34-38 hours post r-hCG day (end of stimulation cycle [approximately 28 days])|ITT population included all randomized participants who had received at least 1 dose of the study medication.||2PN oocytes|||Number
813015|NCT01075815|Secondary|Number of Mature Oocytes Retrieved|Number of mature oocytes retrieved per reporting group on the day of OPU (34-38 hours post r-hCG day (end of stimulation cycle [approximately 28 days]) was calculated. Oocyte retrieval is a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body. The nuclear maturity was evaluated based on the presence of a germinal vesicle (GV) or whether oocytes were in metaphase I (Meta-I) or II (Meta-II) stage.|34-38 hours post r-hCG day (end of stimulation cycle [approximately 28 days])|ITT population included all randomized participants who had received at least 1 dose of the study medication.||mature oocytes|||Number
813016|NCT01075815|Secondary|Mean Number of Oocytes Retrieved|Mean number of oocytes retrieved per reporting group on the day of OPU (34-38 hours post r-hCG day (end of stimulation cycle [approximately 28 days]) was calculated. Oocyte retrieval is a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body.|34-38 hours post r-hCG day (end of stimulation cycle [approximately 28 days])|ITT population included all randomized participants who had received at least 1 dose of the study medication.||oocytes||Standard Deviation|Mean
813017|NCT01075815|Secondary|Mean Number of Follicles Greater Than or Equal to 14 Millimeter (mm) on Recombinant Human Choriogonadotropin (r-hCG) Day||r-hCG day (end of stimulation cycle [approximately 28 days])|ITT population included all randomized participants who had received at least 1 dose of the study medication.||follicles||Standard Deviation|Mean
813018|NCT01075815|Primary|Implantation Rate|Implantation rate was measured as the number of gestational sacs observed, divided by the number of embryos transferred.|Day 35-42 post ovum pick-up (OPU) (34-38 hours post recombinant human choriogonadotropin day {end of stimulation cycle}[approximately 28 days])|Intention to treat (ITT) population included all randomized participants who had received at least 1 dose of the study medication.||sacs per embryo||Standard Deviation|Mean
813019|NCT01075958|Primary|Word Recognition (Episodic Memory)|The original 15 words plus 15 distractor words were presented one at a time in a random order. For each word the participant indicated whether or not it was included in the original list of words by pressing appropriate ‘yes’ and ‘no’ keys as quickly as possible. Stimuli remained on screen until an appropriate response had been made.|Single visit|||percent of correct responses||Standard Error|Mean
813020|NCT01075958|Primary|Delayed Word Recall (Episodic Memory)|The participant was again given 60 seconds to write down as many of the words presented previously as possible.|Single visit|||Number of words recalled||Standard Error|Mean
814053|NCT01083758|Primary|Change in Albumincorrected Serum Calcium From Baseline (SV2) to Week 4, Week 8, and End of Treatment.|Change in albumincorrected serum calcium from Baseline (SV2 = screening visit 2) to Week 4, Week 8, and end of treatment.|Baseline and week 4|||mmol/L||Standard Deviation|Mean
813021|NCT01075958|Primary|Immediate Word Recall (Episodic Memory)|A unique set of fifteen words is presented. Words were selected at random from a large bank of words derived from the MRC Psycholinguistic Database matched for word length, frequency, familiarity and concreteness. Stimulus duration was one second, as was the inter-stimulus duration. Following word presentation, the participant was allowed 60 seconds to write down as many of the words as possible.|Single visit|||Number of words recalled||Standard Error|Mean
813022|NCT01075958|Primary|3-back Task (Working Memory)|A continuous string of letters (upper and lower case; inter-stimulus interval of 2.5 seconds) was presented; 45 letters in total with 15 target pairs. For each stimulus, participants were instructed to indicate whether this was the same letter that appeared three letters before.|Single visit|||percent of correct responses||Standard Error|Mean
813023|NCT01075958|Primary|Corsi Blocks Span (Spatial Working Memory)|In this task nine identical blue squares appeared on screen in non-overlapping random positions. A set number of blocks changed colour from blue to red in a randomly generated sequence. Participants were instructed to repeat the sequence by clicking on the blocks using the mouse and cursor. The task was repeated five times at each level of difficulty. The sequence span increased from 4, until the participant could no longer correctly recall the sequence, resulting in a span measure of nonverbal working memory, calculated by averaging the level of the last five correctly completed trials.|Single visit|||Blocks remembered in sequence||Standard Error|Mean
813024|NCT01075958|Primary|Alphabetic Working Memory (Working Memory)|Five random letters (A-Z) were presented sequentially for the participant to hold in memory. This was followed by a series of 30 probe digits (15 targets and 15 distractors) for each of which the participant indicated whether or not it had been in the original series by a simple key press. The task consisted of 3 separate trials.|Single visit|||percent of correct responses||Standard Error|Mean
813025|NCT01075958|Primary|Numeric Working Memory (Working Memory)||Single visit|||percent of correct responses||Standard Error|Mean
813026|NCT01075958|Primary|Four Choice Reaction Time (Attention)|A visual representation of the four direction arrow keys of a standard keyboard was presented on screen. The arrows ‘lit up’ at random on screen until the corresponding key press was made. In all, each arrow was the target stimulus 12 times, forming a total of 48 stimuli for this task in all.|Single visit|||ms||Standard Error|Mean
813027|NCT01075958|Primary|Choice Reaction Time (Attention)|An arrow appeared on the screen pointing to the left or to the right. Participants responded with a left or right key press corresponding to the direction of the arrow. There was a randomly varying inter-stimulus interval of between 1 and 3 seconds for a total of fifty stimuli.|Single visit|||ms||Standard Error|Mean
813028|NCT01075958|Secondary|Depression, Anxiety and Stress Scale (DASS)|The DASS is a set of three self-report scales designed to measure the negative emotional states of depression, anxiety and stress. Each of the three DASS scales contains 14 items. Subjects are asked to use 4-point (0-3) severity/frequency scales to rate the extent to which they have experienced each state over the past week. Scores for Depression, Anxiety and Stress (0-42) are calculated by summing the scores for the relevant items, with higher scores indicating higher incidence of negative emotional symptoms. A total score can be derived by adding scores from each of the subscales (0-126).|Single visit-90 minutes|||Scores on a scale||Standard Deviation|Mean
813029|NCT01075958|Primary|Simple Reaction Time (Attention)|The participant was instructed to press the ‘space bar’ on the laptop keyboard as quickly as possible every time an upwards pointing arrow appeared on screen. Fifty stimuli were presented with an inter-stimulus duration that varied randomly between 1 and 3.5 seconds.|Single visit|Only those participants for whom a venous blood sample was obtained (N=239) were entered into the analysis. A further 20 participants were excluded on the basis that their BMI exceeded 30, and could not be considered 'healthy individuals'.||ms||Standard Error|Mean
813030|NCT01075971|Primary|The Overall Preference Between Two Buprenorphine Sublingual Formulations, After a Switch From the Marketed Tablet (Subutex®) to the New Fast Dissolving Tablet (FDT), in Opioid-dependent Patients With Buprenorphine 8 mg or 16 mg Daily Maintenance Therapy.|"Patient's overall satisfaction on Day 1 to Day 5 postdose. Marketed sublingual tablet (Marketed SL): Days 1 and 2; Fast dissolving tablet (FTD): Days 3, 4, and 5. Within 1 hour after complete dissolution of the tablet(s), overall satisfaction towards the study treatment was to be scored by the patient himself / herself using a 10-cm visual analogic scale (VAS) ranging from Not at all satisfied (score = 0) to Totally satisfied (score = 10)."|Daily, Day 1 to Day 5|||Score on a scale||Standard Deviation|Mean
813031|NCT01075984|Primary|Steady State Apparent Total Body Clearance of Oral Posaconazole (CL/F)|Blood samples were collected from participants for the determination of plasma POS concentration.|Predose and 3, 5, 8 and 12 hours after dosing on Day 7 (Cohort 0), or Day 28 (Cohorts 1 and 2)|CL/F for posaconazole was not calculated in this study because it was collected in other studies more appropriate for evaluation of this parameter|||||
813032|NCT01075984|Primary|Steady State Average Concentration of Oral Posaconazole (Cavg)|Blood samples were collected from participants for the determination of plasma POS concentration. Cavg was calculated as steady state AUC / dosing interval (12 hours).|Predose and 3, 5, 8 and 12 hours after dosing on Day 7 (Cohort 0), or Day 28 (Cohorts 1 and 2)|The PK-evaluable population included participants who had no major protocol violations and had documented adherence to the dosing and PK regimens. Cohort 3 was not evaluated for this outcome measure.||ng/mL||Standard Deviation|Mean
813033|NCT01075984|Primary|Steady State Area Under the Concentration Versus Time Curve of Oral Posaconazole (AUC)|Blood samples were collected from participants for the determination of plasma POS concentration.|Predose and 3, 5, 8 and 12 hours after dosing on Day 7 (Cohort 0), or Day 28 (Cohorts 1 and 2)|The PK-evaluable population included participants who had no major protocol violations and had documented adherence to the dosing and PK regimens. Cohort 3 was not evaluated for this outcome measure.||hour*ng/mL||Standard Deviation|Mean
813034|NCT01075984|Primary|Steady State Time of Observed Maximum Concentration of Oral Posaconazole (Tmax)|Blood samples were collected from participants for the determination of plasma POS concentration.|Predose and 3, 5, 8 and 12 hours after dosing on Day 7 (Cohort 0), or Day 28 (Cohorts 1 and 2)|The PK-evaluable population included participants who had no major protocol violations and had documented adherence to the dosing and PK regimens. Cohort 3 was not evaluated for this outcome measure.||Hours||Full Range|Median
814083|NCT01084005|Secondary|Number of Patients With Rescue Therapy|The use of rescue therapy was planned for patients failing to achieve preset criteria based on glucose levels during the randomised treatment period of the trial|week 24|FAS (OC)||Number of patients|||Number
813035|NCT01075984|Primary|Steady State Maximum Concentration of Oral Posaconazole (Cmax)|Blood samples were collected from participants for the determination of plasma POS concentration.|Predose and 3, 5, 8 and 12 hours after dosing on Day 7 (Cohort 0), or Day 28 (Cohorts 1 and 2)|The PK-evaluable population included participants who had no major protocol violations and had documented adherence to the dosing and PK regimens. Cohort 3 was not evaluated for this outcome measure.||ng/mL||Standard Deviation|Mean
813036|NCT01075984|Primary|Steady State Trough Concentration of Oral Posaconazole (Cmin)|Blood samples were collected from participants for the determination of plasma POS concentration.|12 hours after dosing on Day 7 (Cohort 0), or Day 28 (Cohorts 1 and 2)|The PK-evaluable population included participants who had no major protocol violations and had documented adherence to the dosing and PK regimens. Cohort 3 was not evaluated for this outcome measure.||ng/mL||Standard Deviation|Mean
813037|NCT01075984|Primary|Steady State Total Body Clearance of IV Posaconazole (CL)|Blood samples were collected from participants for the determination of plasma POS concentration.|Predose and 1, 1.5, 1.75, 4, 8, and 12 hours after start of infusion on Day 14 (Cohorts 1 and 2), or Day 10 (Cohort 3)|CL for posaconazole was not calculated in this study because it was collected in other studies more appropriate for evaluation of this parameter.|||||
813038|NCT01075984|Primary|Steady State Average Concentration of IV Posaconazole (Cavg)|Blood samples were collected from participants for the determination of plasma POS concentration. Cavg was calculated as steady state AUC / dosing interval (24 hours).|Predose and 1, 1.5, 1.75, 4, 8, 12, and 24 hours after start of infusion on Day 14 (Cohorts 1 and 2), or Day 10 (Cohort 3)|The PK-evaluable population included participants who had no major protocol violations and had documented adherence to the dosing and PK regimens.||ng/mL||Standard Deviation|Mean
813039|NCT01075984|Primary|Steady State Area Under the Concentration Versus Time Curve of IV Posaconazole (AUC)|Blood samples were collected from participants for the determination of plasma POS concentration.|Predose and 1, 1.5, 1.75, 4, 8, 12, and 24 hours after start of infusion on Day 14 (Cohorts 1 and 2), or Day 10 (Cohort 3)|The PK-evaluable population included participants who had no major protocol violations and had documented adherence to the dosing and PK regimens.||hour*ng/mL||Standard Deviation|Mean
813040|NCT01075984|Primary|Single Dose Area Under the Concentration Versus Time Curve of IV Posaconazole (AUC)|Blood samples were collected from participants for the determination of plasma POS concentration.|Predose and 1, 1.5, 1.75, 4, 8, and 12 hours after start of infusion on Day 1 (Cohorts 0, 1 and 2)|The PK-evaluable population included participants who had no major protocol violations and had documented adherence to the dosing and PK regimens. Cohort 3 was not evaluated for this outcome measure.||hour*ng/mL||Standard Deviation|Mean
813041|NCT01075984|Primary|Steady State Time of Observed Maximum Concentration of IV Posaconazole (Tmax)|Blood samples were collected from participants for the determination of plasma POS concentration.|Predose and 1, 1.5, 1.75, 4, 8, and 12 hours after start of infusion on Day 14 (Cohorts 1 and 2), or Day 10 (Cohort 3)|The PK-evaluable population included participants who had no major protocol violations and had documented adherence to the dosing and PK regimens.||Hours||Full Range|Median
813042|NCT01075984|Primary|Single Dose Time of Observed Maximum Concentration of IV Posaconazole (Tmax)|Blood samples were collected from participants for the determination of plasma POS concentration.|Predose and 1, 1.5, 1.75, 4, 8, and 12 hours after start of infusion on Day 1 (Cohorts 0 and 1)|The PK-evaluable population included participants who had no major protocol violations and had documented adherence to the dosing and PK regimens. Cohort 3 was not evaluated for this outcome measure.||Hours||Full Range|Median
813043|NCT01075984|Primary|Steady State Maximum Concentration of IV Posaconazole (Cmax)|Blood samples were collected from participants for the determination of plasma POS concentration.|Predose and 1, 1.5, 1.75, 4, 8, and 12 hours after start of infusion on Day 14 (Cohorts 1 and 2), or Day 10 (Cohort 3)|The PK-evaluable population included participants who had no major protocol violations and had documented adherence to the dosing and PK regimens.||ng/mL||Standard Deviation|Mean
813044|NCT01075984|Primary|Single Dose Maximum Concentration of IV Posaconazole (Cmax)|Blood samples were collected from participants for the determination of plasma POS concentration.|Predose and 1, 1.5, 1.75, 4, 8, and 12 hours after start of infusion on Day 1 (Cohorts 0, 1 and 2)|The PK-evaluable population included participants who had no major protocol violations and had documented adherence to the dosing and PK regimens. Cohort 3 was not evaluated for this outcome measure.||ng/mL||Standard Deviation|Mean
813045|NCT01075984|Primary|Steady State Trough Concentration of IV Posaconazole (Cmin)|Blood samples were collected from participants for the determination of plasma POS concentration.|24 hours after start of infusion on Day 14 (Cohorts 1 and 2), or Day 10 (Cohort 3)|The PK-evaluable population included participants who had no major protocol violations and had documented adherence to the dosing and PK regimens.||ng/mL||Standard Deviation|Mean
813046|NCT01075984|Primary|Single Dose Trough Concentration of IV Posaconazole (Cmin)|Blood samples were collected from participants for the determination of plasma POS concentration.|12 hours after start of infusion on Day 1 (Cohorts 0, 1 and 2)|The PK-evaluable population included participants who had no major protocol violations and had documented adherence to the dosing and PK regimens. Cohort 3 was not evaluated for this outcome measure.||ng/mL||Standard Deviation|Mean
813047|NCT01076036|Primary|Procedural Technical Success|Successful robotic delivery and retraction of all PCI devices during CorPath PCI procedure.|Intervention|Total number of PCI devices.||percentage of PCI devices|||Number
813048|NCT01076036|Primary|Clinical Procedural Success|The percentage of Participants with <30% final diameter stenosis of the target lesion without in-hospital major adverse cardiovascular events (MACE) (defined as the composite of death, recurrent MI, and target vessel revascularization)|48-hrs or hospital discharge, whichever occurs first|||percentage of participants|||Number
813049|NCT01076075|Primary|Number of Participants Discontinuing Study Drug Due to An Adverse Event||Week 0 to Week 54|The All Patients as Treated Population took at least 1 dose of study drug. Participants received glycemic rescue medication if they met specific glycemic goals up to Week 24. Participants discontinued due to adverse events are reported regardless of rescue medication. Five participants were excluded from analyses due to 1 site's non-compliance.||participants|||Number
813050|NCT01076075|Primary|Number of Participants With One or More Adverse Events (AEs) - Week 0 to Week 54||Week 0 to Week 54|The All Patients as Treated Population took at least one dose of study drug. Participants received glycemic rescue medication if they met specific glycemic goals up to Week 24. Adverse events include those that occurred prior to a receiving rescue medication. Five participants were excluded from analyses due to 1 site's non-compliance.||participants|||Number
813051|NCT01076075|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 24|Change from baseline reflects the Week 24 value minus the baseline value.|Baseline to Week 24|The Full Analysis Set Population received at least one dose of study treatment and had baseline data and at least one post-baseline treatment endpoint observation for the analysis endpoint. Missing data were imputed using last observation carried forward (LOCF). Five participants were excluded from analyses due to one site's non-compliance.||mg/dL||95% Confidence Interval|Least Squares Mean
813052|NCT01076075|Secondary|Change From Baseline in 2-hour Post-Meal Glucose at Week 24|Change from baseline reflects the Week 24 value minus the baseline value. Two-hour post-meal glucose was measured following a standard meal.|Baseline and Week 24|The Full Analysis Set Population received at least one dose of study treatment and had baseline data and at least one post-baseline treatment endpoint observation for the analysis endpoint. Missing data were imputed using last observation carried forward (LOCF). Five participants were excluded from analyses due to one site's non-compliance.||mg/dL||95% Confidence Interval|Least Squares Mean
813053|NCT01076075|Primary|Change From Baseline in Hemoglobin A1C (%) at Week 24|Change from baseline reflects the Week 24 value minus the baseline value. A1C represents the percentage of glycosylated hemoglobin.|Baseline and Week 24|The Full Analysis Set Population received at least one dose of study treatment and had baseline data and at least one post-baseline treatment endpoint observation for the analysis endpoint. Missing data were imputed using last observation carried forward (LOCF). Five participants were excluded from analyses due to one site's non-compliance.||Percentage of glycosylated hemoglobin||95% Confidence Interval|Least Squares Mean
813054|NCT01076088|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Change from baseline in FPG at Week 24 is defined as Week 24 FPG minus Week 0 FPG.|Baseline and Week 24|Full Analysis Set, all randomized participants except those who: failed to take at least 1 dose of study treatment, lacked all post-randomization data for FPG subsequent to at least 1 dose of study treatment, or lacked baseline data for FPG. Last observation carried forward (missing data approach).||mg/dL||95% Confidence Interval|Least Squares Mean
813055|NCT01076088|Secondary|Change From Baseline in 2-hour Post Meal Glucose (2-h PMG) at Week 24|Change from baseline in 2-h PMG at Week 24 is defined as Week 24 2-h PMG minus Week 0 2-h PMG.|Baseline and Week 24|Full Analysis Set, all randomized participants except those who: failed to take at least 1 dose of study treatment, lacked all post-randomization data for 2-h PMG subsequent to at least 1 dose of study treatment, or lacked baseline data for 2-h PMG. Last observation carried forward (missing data approach).||mg/dL||95% Confidence Interval|Least Squares Mean
813056|NCT01076088|Primary|Change From Baseline in Hemoglobin A1C (A1C) at Week 24|A1C is measured as percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.|Baseline and Week 24|Full Analysis Set, all randomized participants except those who: failed to take at least 1 dose of study treatment, lacked all post-randomization data for the A1C subsequent to at least 1 dose of study treatment, or lacked baseline data for the A1C. Last observation carried forward (missing data approach).||Percent of glycosylated hemoglobin||95% Confidence Interval|Least Squares Mean
813057|NCT01076153|Secondary|Number and Type of Adverse Events|Adverse events were collected during the course of the study up to 30 days or 5 half-lives following the last dose of Klacid. The number of participants experiencing a serious or non-serious adverse event is summarized. See the Reported Adverse Event section for details.|Baseline to 14 days|The safety population included all participants who took at least 1 dose of Klacid.||Events|||Number
813058|NCT01076153|Primary|Average Time From Baseline to Recovery From Cough and Other Symptoms|Study participants were seen at an initial visit (baseline) and received Klacid treatment for 5 to 14 days. A medical appointment (visit or phone call) was made 6 to 14 days after the first visit. Participants' symptoms were rated using one of the following categories: resolved, improved, not changed, or worse. Associated dates were also recorded. Symptoms included, but were not limited to, cough, fever, and sore throat. Recovery was defined as the disappearance of all signs and symptoms of infection.|Baseline to 14 days|The per-protocol population consisted of 694 participants as 66 participants were excluded for protocol deviations (some more than 1): Age less than 18 years (22), took excluded drugs (17), took Klacid more than 14 days (16), took Klacid less than 5 days (11), added 250 mg Klacid to Klacid MR (5), and used injectable drugs (3).||Days||Standard Deviation|Mean
813059|NCT01076166|Secondary|Number and Type of Adverse Events|Adverse events were collected during the course of the study up to 30 days or 5 half-lives following the last dose of Klacid. The number of participants experiencing a serious or non-serious adverse event are summarized. See the Reported Adverse Event section for details.|Baseline to 14 days|The safety population included all participants who took at least 1 dose of Klacid.||Participants|||Number
813060|NCT01076166|Primary|Average Time From Baseline to Recovery From Fever and Other Symptoms|Participants were observed during his/her Klacid treatment (5 to 14 days). A medical appointment was made 6 to 14 days after the first visit. Participants' symptoms were rated using one of the following categories: resolved, improved, not changed, or worse. Associated dates were also recorded. Symptoms included, but were not limited to, fever, cough, chest/abdominal pain, and vomiting. Recovery was defined as the disappearance of all signs and symptoms of infection.|Baseline to 14 days|A total of 29 patients were excluded for protocol deviations: Took Klacid less than 5 days (9), took Klacid more than 14 days (4), Klacid intravenous formulation used instead of granules (9), participants enrolled prior to signed study agreement (5), and age less than 6 months (2). Average time to recovery was based on 171 recovered patients.||Days||Standard Deviation|Mean
813061|NCT01076179|Other Pre-specified|Time to Virologic Failure|"Time to virologic failure was defined by the earliest occurrence of:
HIV-1 RNA > 400 copies/mL confirmed on 2 consecutive occasions after achieving at least 1 HIV-1 RNA < 50 copies/mL,
HIV-1 RNA > 400 copies/mL at the final on-study visit if the participant had previously experienced at least 1 HIV-1 RNA < 50 copies/mL but subsequently did not have HIV-1 RNA > 400 copies/mL on 2 consecutive occasions, or
Day 1 if the participant never achieved HIV-1 RNA < 50 copies/mL during study participation.
A participant who prematurely discontinued study drug with HIV-1 RNA < 50 copies/mL was censored from analysis at the time of discontinuation provided that he/she did not previously experience either (a), (b) or (c)."|Baseline (Week 0) to Week 144|Participants with an assessment||weeks||Standard Error|Mean
813103|NCT01076348|Primary|Model 4965 Complication Free Rate|A 4965 lead-related complication is an adverse event requiring invasive intervention to resolve. The complication-free rate is based on the number of leads analyzed.|1 year|Patients ≥ 19 yrs at implant of MDT 4965 Epicardial Lead.||Model 4965 complication free rate|Participants|95% Confidence Interval|Number
813063|NCT01076179|Secondary|Number of Participants With HIV-1 Coreceptor Tropism During Follow-up|Participants with CCR5 tropic virus, CXC motif chemokine receptor 4 (CRCX4) tropic virus, or dual/mixed tropic virus at Follow-up.|up to Week 144|Since this was an observational study, resistance testing was performed at the discretion of the treating physician. No follow-up data on tropism was collected.|||||
813064|NCT01076179|Secondary|Number of Participants With HIV-1 Coreceptor Tropism at Baseline|Participants with CCR5 tropic virus, CXC motif chemokine receptor 4 (CRCX4) tropic virus, or dual/mixed tropic virus at Baseline.|Baseline (Week 0)|Participants with an assessment at Baseline||Participants|||Count of Participants
813065|NCT01076179|Secondary|Number of Participants With NRTI Resistance During Follow-Up|"Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). Susceptible indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. Partial resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). Resistant indicates that high level drug resistance has to be expected."|up to Week 144|Participants with an assessment at follow-up; since this was an observational study, resistance testing was performed at the discretion of the treating physician.||Participants|||Count of Participants
813066|NCT01076179|Secondary|Number of Participants With Nucleoside Analog Reverse-Transcriptase Inhibitor (NRTI) Resistance at Baseline|"Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). Susceptible indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. Partial resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). Resistant indicates that high level drug resistance has to be expected."|Baseline (Week 0)|Participants with an assessment at Baseline||Participants|||Count of Participants
813067|NCT01076179|Secondary|Number of Participants With NNRTI Resistance During Follow-Up|"Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). Susceptible indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. Partial resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). Resistant indicates that high level drug resistance has to be expected."|up to Week 144|Participants with an assessment at follow-up; since this was an observational study, resistance testing was performed at the discretion of the treating physician.||Participants|||Count of Participants
813068|NCT01076179|Secondary|Number of Participants With NNRTI Resistance at Baseline|"Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). Susceptible indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. Partial resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). Resistant indicates that high level drug resistance has to be expected."|Baseline (Week 0)|Participants with an assessment at Baseline||Participants|||Count of Participants
813069|NCT01076179|Secondary|Number of Participants With INI Resistance During Follow-Up|"Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). Susceptible indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. Partial resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). Resistant indicates that high level drug resistance has to be expected."|up to Week 144|Participants with an assessment at follow-up (neither had available Baseline testing); since this was an observational study, resistance testing was performed at the discretion of the treating physician.||Participants|||Count of Participants
813070|NCT01076179|Secondary|Number of Participants With INI Resistance at Baseline|"Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). Susceptible indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. Partial resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). Resistant indicates that high level drug resistance has to be expected."|Baseline (Week 0)|Participants with an assessment at Baseline||Participants|||Count of Participants
813071|NCT01076179|Secondary|Number of Participants With PI Resistance During Follow-Up|"Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). Susceptible indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. Partial resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). Resistant indicates that high level drug resistance has to be expected."|Up to Week 144|Participants with an assessment during follow-up; since this was an observational study, resistance testing was performed at the discretion of the treating physician.||Participants|||Count of Participants
814279|NCT01084551|Secondary|Average Duration of RLS Symptoms|Change of average duration of RLS symptoms in a week from baseline to the end of dose-titration/dose-maintenance period. Only the days with RLS symptoms are used for calculation.|Baseline, the end of dose-titration/dose-maintenance period (weeks 13)|FAS, LOCF||Hours||Standard Deviation|Mean
813072|NCT01076179|Secondary|Number of Participants With Protease Inhibitor (PI) Resistance at Baseline|"Characterization of baseline resistance and development of resistance using the interpretation system HIV-Genotypic Resistance-Algorithm Deutschland (GRADE; available at www.hiv-grade.de.
Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). Susceptible indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. Partial resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). Resistant indicates that high level drug resistance has to be expected."|Baseline (Week 0)|Participants with an assessment at Baseline||Participants|||Count of Participants
813073|NCT01076179|Secondary|Number of Participants With LPV Resistance During Follow-Up|"Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). Susceptible indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. Partial resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). Resistant indicates that high level drug resistance has to be expected."|up to Week 144|Participants with an assessment during follow-up; since this was an observational study, resistance testing was performed at the discretion of the treating physician.||Participants|||Count of Participants
813074|NCT01076179|Secondary|Number of Participants With Lopinavir (LPV) Resistance at Baseline|"Characterization of baseline resistance and development of resistance using the interpretation system HIV-Genotypic Resistance-Algorithm Deutschland (GRADE; available at www.hiv-grade.de.
Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). Susceptible indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. Partial resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). Resistant indicates that high level drug resistance has to be expected."|Baseline (Week 0)|Participants with an assessment at Baseline||Participants|||Count of Participants
813075|NCT01076179|Secondary|Time to CD4 Cell Count Increase From Baseline of ≥ 100/ Cells/μL||From Week 0 to Week 144|Participants with an assessment||weeks||Standard Error|Mean
813076|NCT01076179|Secondary|Percentage of Participants Achieving Absolute CD4 Cell Count Increases From Baseline of ≥ 100 Cells/μL at All Time Points, As Treated Analysis|Changes in participants' CD4 cell counts were assessed by measuring the number of CD4 cells at scheduled visits planned as part of routine care.|Baseline (Week 0) to Week 144|'As treated' analyses: participants with an assessment, missing data excluded. Number analyzed=participants with an assessment at given time point.||percentage of participants|||Number
813077|NCT01076179|Secondary|Percentage of Participants Achieving Absolute CD4 Cell Count Increases From Baseline of ≥ 100 Cells/μL at All Time Points, Modified Intent-to-Treat Analysis|Changes in participants' CD4 cell counts were assessed by measuring the number of CD4 cells at scheduled visits planned as part of routine care.|Baseline (Week 0) to Week 144|Modified 'intent-to-treat' analysis: missing values were replaced by the last observed value of that variable (last observation carried forward method).||percentage of participants|||Number
813078|NCT01076179|Secondary|Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count|Changes in participants' CD4 cell counts were assessed by measuring the change from Baseline in the number of CD4 cells at scheduled visits planned as part of routine care.|Baseline (Week 0) to Week 144|Participants with an assessment at Baseline. Number analyzed=participants with an assessment at given time point.||cells/μL||Standard Deviation|Mean
813079|NCT01076179|Primary|Prevalence of Adverse Events (Weeks 0-144), Per Participant|Percentage of participants who experienced at least 1 adverse event during Weeks 0-144 by adverse event type. Doctors asked participants for adverse events, grouped them into categories given in the eCRF. The list of adverse events included in the eCRF were hypertriglyceridemia, hypercholesterolemia, low HDL cholesterol, high LDL cholesterol, hyperglycemia, hyperbilirubinemia, elevated AST, elevated ALT, elevated γGT, elevated alkaline phosphatase, stomatitis, nausea, vomiting, diarrhea, abdominal pain, mood disorder, neurocerebellar disorder, headache, fatigue, fever, other (listed as 'not specified').|Weeks 0 to 144|||percentage of participants|||Number
813080|NCT01076179|Primary|Prevalence of Adverse Events (Weeks 0-144), Per Event|Percentage of overall number of adverse events experienced during Weeks 0-144 by adverse event type. Doctors asked participants for adverse events, grouped them into categories given in the electronic case report form (eCRF). The list of adverse events included in the eCRF were hypertriglyceridemia, hypercholesterolemia, low high density lipoprotein (HDL) cholesterol, high low density lipoprotein (LDL) cholesterol, hyperglycemia, hyperbilirubinemia, elevated aspartate aminotransferase (AST), elevated alanine aminotransferase (ALT), elevated gamma glutamyl transferase (γGT), elevated alkaline phosphatase, stomatitis, nausea, vomiting, diarrhea, abdominal pain, mood disorder, neurocerebellar disorder, headache, fatigue, fever, other (listed as 'not specified').|Weeks 0 to 144|||percentage of adverse events|Adverse Events||Number
813081|NCT01076192|Secondary|Number of Participants With Serious Adverse Events (SAEs)|"SAEs are adverse event with any of the following severity criteria: Potentially fatal/endangers life, Hospitalisation or prolonging of hospitalisation, a medically important event that requires medical or surgical intervention to prevent a serious outcome, Disability or persistent incapacitation, death, congenital anomalies and/or miscarriage or abortion.
See the Reported Adverse Events Section for more details."|From time of informed consent to the final visit after 2 years of observation|Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.||participants|||Number
813082|NCT01076192|Primary|Percentage of Participants With Improvement From Baseline in Physician's Global Assessment (PGA)|The PGA was used to measure participants’ disease status at the time of assessment. This tool is a horizontal visual analogue 6-point scale measuring the degree of overall psoriatic lesion severity, and scores range from 0 (clear) to 5 (very severe). The percentage of patients who showed an improvement from baseline in their PGA scores is presented. Missing data were imputed using LOCF.|Baseline, month 1 and every 3 months the first year and every 6 months up to month 24|Efficacy analyses included ITT population with evaluable data.||percentage of participants|||Number
813083|NCT01076192|Primary|Mean Change From Baseline in Body Surface Area (BSA) Affected|Body Surface Area (BSA) affected or the psoriasis area is determined by the direct calculation of the affected body surface area. This determination was used to evaluate the effectiveness of the treatment during each of the study visits. The change was calculated by deducting the final score from the baseline score. Increased scores correspond to reduction of severity and reduction of BSA. Missing data were imputed using LOCF.|Baseline, month 1 and every 3 months the first year and every 6 months up to month 24|Efficacy analyses included ITT population with evaluable data.||percentage of body surface area||Standard Deviation|Mean
813084|NCT01076192|Primary|Percentage of Participants Achieving a Reduction in PASI Score of 100% (PASI 100)|PASI is a measurement of the severity of psoriasis. It is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI 100 response is the percentage of participants who achieved a 100% reduction (improvement) from baseline in PASI score. Missing data were imputed using LOCF.|Baseline, month 1 and every 3 months the first year and every 6 months up to month 24|Efficacy analyses included ITT population with evaluable data.||percentage of participants|||Number
813085|NCT01076192|Primary|Percentage of Participants Achieving a Reduction in PASI Score of at Least 90% (PASI 90)|PASI is a measurement of the severity of psoriasis. It is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI 90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score. Missing data were imputed using LOCF.|Baseline, month 1 and every 3 months the first year and every 6 months up to month 24|Efficacy analyses included ITT population with evaluable data.||percentage of participants|||Number
813086|NCT01076192|Secondary|Number of Participants With Adverse Events of Special Interest (AESIs)|AESIs are adverse events of special interest, including infection, neoplasm, lupus-like, demyelinating disease, serious hepatic and/or haematological event.|From time of informed consent to the final visit after 2 years of observation|Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.||participants|||Number
813087|NCT01076192|Secondary|Mean Change From Baseline in Percentage of Lost Productivity Assessed Using Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP)|WPAI-SHP is a questionnaire used to evaluate lost productivity. The scores on the WPAI questionnaire are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Change in WPAI-SHP was calculated by deducting the final score from the baseline score. Increased (positive) scores correspond to a reduction in the percentage of lost work productivity. Missing data were imputed using LOCF. n=the number of participants with data at each time point.|Baseline and every 6 months up to month 24|Analysis included ITT population with evaluable data.||units on a scale (a derived score)||Standard Deviation|Mean
813088|NCT01076192|Secondary|Mean Change From Baseline in EuroQol Quality of Life Questionnaire (EQ-5D) Visual Analogue Scale (VAS)|The EQ-5D VAS records the participant's self-rated health on a scale from 0-100 where increased scores correspond to better HRQL. 0 is the 'worst imaginable health state' and 100 is the 'best imaginable health state'. Change in EQ-5D VAS score was calculated by deducting the final score from the baseline score. Increased scores correspond to better health state. Missing data were imputed using LOCF.|Baseline and every 6 months up to month 24|Analysis included ITT population with evaluable data.||units on a scale||Standard Deviation|Mean
813089|NCT01076192|Secondary|Mean Change From Baseline in Dermatology Life Quality Index (DLQI)|DLQI is a self-administered Health Related Quality of Life (HRQL) questionnaire specifically for patients with dermatological diseases, adapted and validated in the Spanish population. It consists of 10 items with a Likert response scale for 4 categories and uses a 7 day time reference. It generates a global score that ranges from 0 (better HRQL) to 30 (worse HRQL) points. Change in DLQI was calculated by deducting the final score from the baseline score. Missing data were imputed using LOCF.|Baseline and every 6 months up to month 24|Efficacy analyses included ITT population with evaluable data.||units on a scale||Standard Deviation|Mean
813090|NCT01076192|Primary|Percentage of Participants Achieving a Reduction in PASI Score of at Least 75% (PASI 75)|PASI is a measurement of the severity of psoriasis. It is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI 75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score. Missing data were imputed using LOCF.|Baseline, month 1 and every 3 months the first year and every 6 months up to month 24|Efficacy analyses included ITT population with evaluable data.||percentage of participants|||Number
813091|NCT01076192|Primary|Percentage of Participants Achieving a Reduction in PASI Score of at Least 50% (PASI 50)|PASI is a measurement of the severity of psoriasis. It is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI 50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score. Missing data were imputed using LOCF.|Baseline, month 1 and every 3 months the first year and every 6 months up to month 24|Efficacy analyses included ITT population with evaluable data.||percentage of participants|||Number
813104|NCT01076361|Primary|Survival Probability of the Model 4968 Lead Based on Lead-related Complications|The survival analysis takes into account: Enrolled participants, lead follow-up time, and adjudicated lead related complications. The life-table method was used to analyze lead survival probability.|The requirement to satisfy the PMA condition of Approval of model 4968 was to have 100 participants followed for a minimum of 5 years to assess the long-term safety.|22 Model 4968s (in 21 participants) was not available for analysis||percentage of Model 4968 Leads|Participants|95% Confidence Interval|Number
824832|NCT01178268|Secondary|Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)||6 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
813092|NCT01076192|Primary|Mean Change From Baseline in Psoriasis Area and Severity Index (PASI)|PASI is a measurement of the severity of psoriasis. It is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A lower (and negative) value of change indicates an increase in the severity of the psoriasis, while a positive value indicates an improvement in the severity of the PS. Missing data were imputed using last observation carried forward (LOCF).|Baseline, month 1 and every 3 months the first year and every 6 months up to month 24|Efficacy analyses included all participants who received at least 1 dose of adalimumab and had at least one follow-up visit (ITT) with evaluable data.||units on a scale||Standard Deviation|Mean
813093|NCT01076244|Secondary|Quality of Life as Measured by Physical Function Scale of the Zurich Claudication Questionnaire (ZCQ).|For this ZCQ domain, a mean score of 1 is the best possible outcome representing 'no limitation' in physical function, whereas a mean score of 4 indicates worst physical function. Zurich Claudication physical function scale from this validated lumbar spine-specific measurement questionnaire are reported below as change from baseline to month 6. A positive value represents the baseline value minus the 6 month value. Treatment is considered clinically relevant when at least a 0.5 improvement is achieved.|Baseline and month 6|All available patients at the month 6 reporting period were analyzed.||units on a scale||95% Confidence Interval|Mean
813094|NCT01076244|Primary|Pain as Measured by Visual Analog Scale (VAS).|A validated ten point scale was used where ten is the worst possible pain and zero represents complete lack of pain. The change from baseline to six months is presented below, where a positive value represents the baseline value minus the 6 month value.|Baseline and six months|all available patients reporting at Month 6||units on a scale||95% Confidence Interval|Mean
813095|NCT01076244|Secondary|Quality of Life as Measured by the Symptom Severity Scale of the Zurich Claudication Questionnaire (ZCQ).|As a validated patient outcome tool specific to lumbar spinal stenosis, Zurich Claudication Questionnaire (ZCQ) captures symptom severity as a quality of life indicator. A mean score of 1 is the best possible outcome representing 'no pain' in symptom severity, whereas higher mean scores up to a maximum of 5 indicate worse patient symptoms. The symptom severity outcomes are presented below as change from baseline to month 6 where a positive value represents the baseline value minus the 6 month value. Treatment is considered 'successful' or 'clinically relevant' if the patient population has at least a 0.5 improvement in symptom severity.|Baseline and month 6|All patients having a month six report report were analyzed.||units on a scale||95% Confidence Interval|Mean
813096|NCT01076244|Secondary|Improvement in Functional Mobility|Measured subjectively by the Oswestry Disability Index. Extent of disturbance in activities of daily living is subjectively reported using this validated instrument.Higher score indicate greater limitations in activity. The questionnaire is divided into 10 topics including pain intensity, personal care, lifting walking standing sitting, sleeping social life, traveling, employment/homemaking. Each topic is rated zero (no pain or no limitation) to 5 (high pain or very limited physically) based on typical pain and/or physical limitations. The worst possible score is 50 (100% disability) and the best score is zero (0% disability).Change from baseline to month 6 is reported below, where a positive value represents the baseline value minus the month 6 value.|baseline and month 6|All available patients at six months were analyzed.||units on a scale||95% Confidence Interval|Mean
813097|NCT01076270|Secondary|CD34-positive Cells Collected|Number of CD34-positive cells collected per kg recipient body weight|At the end of apheresis for cell collection|Trial terminated; only one patient enrolled||CD34-positive cells collected/kg|||Number
813098|NCT01076270|Primary|Successful Collection of Stem Cells|Percentage of donors from whom at least 2 x 10^6 CD34+ cells/kg body weight were collected based on actual recipient body weight|At the end of apheresis for cell collection|Study terminated early. Results are for the one donor enrolled.||Participants|||Count of Participants
813099|NCT01076283|Primary|Alcohol Drinking|"Whether baclofen, as compared to active placebo, results in lower quantity of alcohol consumed during the Alcohol Self-Administration (ASA).
Consistent with O'Malley et al. 2002, the ASA paradigm allows to use a fixed-dose (the priming drink), followed by a 2-hour “free-choice” phase when subjects may choose to drink or not up to 8 mini-drinks. Participants receive a monetary compensation of $3 dollars per each mini-drink not consumed; therefore the amount of minidrinks consumed during the 2-hour sessions ranges 0-8, and the monetary compensation ranges $0-24. The quantity of alcohol consumed during the free-choice session is expressed as standard drinking unit, where a standard drink unit contains about 14 grams of pure alcohol (about 0.6 fluid ounces or 1.2 tablespoons)."|approximately 8 days after drug administration|||standard drinking units||Standard Deviation|Mean
813100|NCT01076283|Primary|Alcohol Urge|"Whether baclofen, as compared to active placebo, results in diminished cue-reactivity responses to alcohol cues in terms of urge to drink [as measured by the Alcohol Urge Questionnaire (AUQ)] during the Cue Reactivity.
The Alcohol Urge Questionnaire (AUQ) consists of eight statements about the respondent’s feelings and thoughts about drinking as they are completing the questionnaire (i.e., right now). The respondent is asked to respond to each statement about alcohol craving via a 7-item Likert scale ranging from strongly disagree to strongly agree. Each item is scored on a 1 to 7 scale (Strongly Disagree = 1 and Strongly Agree = 7). Items 2 and 7 are reverse scored. A total score is computed by summing the item scores and ranges from 8 (lowest craving value) to 56 (highest craving value). Higher scores reflect greater craving (i.e. worse outcome)."|approximately 8 days after drug administration|||units on a scale||Standard Deviation|Mean
813101|NCT01076296|Primary|Percentage of Correct Diagnosis|A comparison of the percentages of correct diagnosis by VSCAN and clinical exam using a McNemar test for matched pairs with ECHO used as the gold standard.|2 years|||percentage of correct diagnosis||95% Confidence Interval|Number
813102|NCT01076335|Primary|Number of Participants Progression Free at 1 Year|Participants prostatic specific antigen (PSA) progression-free or event-free survival (that is, freedom from treatment failure) 1 year postoperatively. Treatment failure defined as objective tumor progression during therapy or in year after surgery, confirmed postoperative PSA ⩾1 ngml − 1, or any postoperative radiation, hormonal or other systemic therapy. Participants who did not undergo surgery within 8 weeks of completing 1 year of therapy on protocol (for any reason, including participant refusal) were counted as treatment failure, as were participants whose surgery was begun and aborted.|1 Year|One participant of 40 enrolled declined presurgical therapy after enrollment and was excluded from analysis.||participants|||Number
813105|NCT01076452|Secondary|The Change From Baseline in the UPDRS Scores Part IV (Complication of Therapy) at 24 Months.|The UPDRS has four parts (Parts I-IV) in which a total of 42 disease characteristics are assessed. Most characteristics are assessed according to their severity on a 0-4 scale (0 = normal, 4 = most substantial impairment), and some are assessed only for absence (score = 0) or presence (score = 1). Part IV includes four categories (11 items) related to dyskinesias, clinical fluctuations of symptoms, and other complications. A summary score ranging from 0 to 23 is generated by adding the four items. The higher score indicates worse condition.|Baseline and 24 months|||units on a scale||Standard Deviation|Mean
813106|NCT01076452|Secondary|The Change From Baseline in the UPDRS Scores Part II (Activity of Daily Living) at 24 Months.|The UPDRS has four parts (Parts I-IV) in which a total of 42 disease characteristics are assessed. Most characteristics are assessed according to their severity on a 0-4 scale (0 = normal, 4 = most substantial impairment), and some are assessed only for absence (score = 0) or presence (score = 1). Part II has 13 items focusing on activities of daily living including walking, writing, dressing and speech. A summary score ranging from 0 to 52 is generated by adding the 13 items. The higher score indicates worse condition.|Baseline and 24 months|||units on a scale||Standard Deviation|Mean
813107|NCT01076452|Primary|The Change From Baseline in the UPDRS-III Score at 24 Months With Deep-brain Stimulation and Without Medication.|The primary outcome measure for the comparison of GPi deep brain stimulation (DBS) to STN DBS is the motor function score of the Unified Parkinson’s Disease Rating Scale (UPDRS Part III) measured while the patient is off medications and on stimulation at follow-up visits post surgery. UPDRS Part III has 14 items assessing motor skills including facial expression and speech, tremors, rigidity, posture, gait, and bradykinesia. Left and right sides (arms, legs, and hands) are assessed separately for seven of the functions. The motor function (UPDRS part III) assessments are done by turning on the stimulation with and without taking PD medications (on/off) at each in-person visit. A summary score ranging from 0 to 108 is generated by adding the 14 specific motor function responses. The higher score indicates the worse motor function.|Baseline and 24 months|||units on a scale||95% Confidence Interval|Mean
813108|NCT01076452|Secondary|The Change From Baseline in the UPDRS Scores Part I (Mentation) at 24 Months.|The UPDRS has four parts (Parts I-IV) in which a total of 42 disease characteristics are assessed. Most characteristics are assessed according to their severity on a 0-4 scale (0 = normal, 4 = most substantial impairment), and some are assessed only for absence (score = 0) or presence (score = 1). Part I has four items assessing intellectual impairment, thought disorder, depression and motivation. A summary score ranging from 0 to16 is generated by adding the four items. The higher score indicates worse condition.|Baseline and 24 months|||units on a scale||Standard Deviation|Mean
813109|NCT01076504|Secondary|Toxicity/Safety|Grade 3/4 toxicities|36 months|All enrolled and treated patients||participants|||Number
813110|NCT01076504|Secondary|Overall Survival|The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death|84 months|All enrolled and treated patients||months||95% Confidence Interval|Median
813111|NCT01076504|Secondary|Time to Progression|Time to progression will be defined as the time from first treatment until objective tumor progression (PD). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|36 months|Includes all enrolled and treated patients||weeks||Full Range|Median
813112|NCT01076504|Secondary|Objective Response Rate|The Percentage of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.|36 months|Includes all patients who were treated and evaluated for response (74 patients - 6 were deemed not evaluable)||percentage of evaluable participants|||Number
813113|NCT01076504|Primary|1-year Survival|Percentage of patients still alive one year after their first treatment|12 months|All enrolled and treated patients||percentage of participants||95% Confidence Interval|Number
813114|NCT01076647|Secondary|Change in Body Weight|Change from baseline in body weight after 26 weeks of treatment|Week 0, Week 26|The FAS included all randomised subjects and missing data is imputed using last observation carried forward (LOCF).||kg||Standard Deviation|Mean
813115|NCT01076647|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Change from baseline in HbA1c after 26 weeks of treatment|Week 0, Week 26|The Full analysis set (FAS) included all randomised subjects and missing data is imputed using last observation carried forward (LOCF).||percentage of glycosylated haemoglobin||Standard Deviation|Mean
813117|NCT01076959|Primary|Patient Effectiveness Response Rating and Effective Rate of Humira With DAS 28 at Week 24|Effectiveness was assessed according to European League Against Rheumatism (EULAR) response criteria. The investigator rated patient response as good, moderate, or none from baseline to Week 24. The DAS 28 index is a measure of activity derived from the number of swollen or tender joints, laboratory tests of inflammation, and patient assessment of global health (10 cm line ranging from very good to very bad).|Week 24|Of the 7740 subjects treated, 938 patients were removed; 16 patients used Humira for another indication, 812 patients had data missing at baseline or at least 1 other time point, and 254 patients were treated with Humira for less than 2 weeks. Patients may have been in more than 1 category.||Percentage of Patients|||Number
813118|NCT01076959|Primary|Patient Effectiveness Response Rating and Effective Rate of Humira With DAS 28 at Week 12|Effectiveness was assessed according to European League Against Rheumatism (EULAR) response criteria. The investigator rated patient response as good, moderate, or none from baseline to Week 12. The DAS 28 index is a measure of activity derived from the number of swollen or tender joints, laboratory tests of inflammation, and patient assessment of global health (10 cm line ranging from very good to very bad).|Week 12|Of the 7740 subjects treated, 938 patients were removed; 16 patients used Humira for another indication, 812 patients had data missing at baseline or at least 1 other time point, and 254 patients were treated with Humira for less than 2 weeks. Patients may have been in more than 1 category.||percentage of patients|||Number
813119|NCT01076959|Primary|Patient Effectiveness Response Rating and Effective Rate of Humira With Disease Activity Score (DAS) 28 at Week 4|Effectiveness was assessed according to European League Against Rheumatism (EULAR) response criteria. The investigator rated patient response as good, moderate, or none from baseline to Week 4. The DAS 28 index is a measure of activity derived from the number of swollen or tender joints, laboratory tests of inflammation, and patient assessment of global health (10 cm line ranging from very good to very bad).|Week 4|Of the 7740 subjects treated, 938 patients were removed; 16 patients used Humira for another indication, 812 patients had data missing at baseline or at least 1 other time point, and 254 patients were treated with Humira for less than 2 weeks. Patients may have been in more than 1 category.||Percentage of patients|||Number
813120|NCT01076959|Secondary|Physicians' Overall Effectiveness Response Rating|"Physicians' rated the level of overall patient improvement as markedly improved, improved, not changed, or not assessable by comparing clinical conditions at Week 24 or at discontinuation with baseline conditions."|Week 24|Of the 7740 subjects treated, 938 patients were removed; 16 patients used Humira for another indication label, 812 patients had data missing at baseline or at least 1 other time point, and 254 patients were treated with Humira for less than 2 weeks. Patients may have been in more than 1 category.||Percentage of Patients|||Number
813121|NCT01076959|Primary|Total Number of Patients With Adverse Events|Adverse events were assessed from the time treatment began until treatment ended after 24 weeks. Details about the adverse events and serious adverse events are presented with the adverse event section of the disclosure. This outcome is measured as a percentage of patients with adverse events.|Baseline to Week 24|The safety population included all patients who received at least one dose of Humira, had one set of case report forms, and were registered with PMDA during the review period.||Percentage of Patients|||Number
813122|NCT01076972|Primary|Number of Patients Included in Each Center for Disease Control and Prevention (CDC) Classification Category for HIV-infected Adults and Adolescents|Number of patients in each CDC category at Baseline (last assessment within 30 days prior to first dose of Kaletra) and after treatment. CDC categories defined as: Category A (asymptomatic acute HIV infection), Category B (symptomatic HIV infection; not Categories A and C), Category C (acquired immunodeficiency syndrome [AIDS] indicator status), Class P-0 (children not confirmed for HIV infection), Class P-1 (children with asymptomatic HIV infection), or Class P-2 (children with symptomatic HIV infection).|Baseline (Month 0) and following last treatment dose during the course of the survey period|Available data for all patients were included.||participants|||Number
813123|NCT01076972|Primary|Mean Number of Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) Copies Per Milliliter (mL) Using a Logarithmic (Base 10) Transformation at Each Visit|Number of HIV RNA copies per mL is presented by the mean per visit for patients that were naive to previous antiretroviral treatment and those that were not. HIV-RNA data reported as < 400 copies/mL were considered 399 copies/mL in calculations. The mean and standard deviation of HIV-RNA levels were thus calculated after logarithmic (base 10) transformation (log10 399 is 2.6). Only observed cases were included in analyses; no data were imputed. n = xx, xx is the number of treatment-naive, treatment-experienced participants who had CD4+ T-cell counts available for analysis at each study visit.|Baseline (Month 0), every 3 months thereafter up to Month 12 and every year thereafter up to Year 8 (Month 96) during the course of the survey period|Available data at each visit for each subgroup of patients who had not received and who had received prior antiretroviral drug therapy were included in the analyses. Data for patients for whom either baseline data or treatment data were missing for a given visit were excluded from the analysis for that visit.||copies/mL||Standard Deviation|Mean
813124|NCT01076972|Primary|Cluster of Differentiation 4 Lymphocyte Count (CD4)|The evolution of patients' CD4-positive (CD4+) T-lymphocyte counts after starting treatment with Kaletra was assessed by measuring the number of CD4+ cells at baseline and each subsequent study visit. CD4+ counts are reported as the number of CD4+ cells per cubic millimeter (cmm) and presented by the mean at each visit. Only observed cases were included in analyses; no data were imputed. n = xx, xx is the number of patients naive to previous antiretroviral treatment and those that were not who had CD4+ T-cell counts available for analysis at each study visit.|Baseline (Month 0), every 3 months thereafter up to Month 12 and every year thereafter up to Year 8 (Month 96) during the course of the survey period|Available data at each visit for each subgroup of patients who had not received and received prior antiretroviral drug therapy were included in the analyses. Data for patients for whom either baseline or treatment data were missing for a given visit were excluded from the analysis for that visit.||cells per cubic millimeter||Standard Deviation|Mean
813125|NCT01076972|Primary|Total Number of Patients With Adverse Drug Reactions|"Number of patients with adverse drug reactions, defined as adverse events for which the causal relationship with Kaletra was something other than not related by the investigator (i.e., probable, possible, or unclear), that occurred in ≥ 5% of patients. Adverse drug reactions are reported by preferred term and inclusive of all those reported at each visit. Although a patient may experience a particular preferred term more than once, each patient was counted only once for each preferred term."|During the course of the survey period up to Year 8|Available data for all patients were included.||participants|||Number
813126|NCT01076985|Primary|Number of Patients With Adverse Drug Reactions (ADRs)|"The number of patients (mothers and infants) with adverse drug reactions, defined as adverse events for which the causal relationship with Kaletra was something other than not related by the investigator (i.e., probable, possible, or unclear). ADRs are reported by preferred term and inclusive of all those reported at any visit. Although a patient may experience a particular preferred term more than once, each patient was counted only once for each preferred term."|During pregnancy and for one year after birth|All available observed data for all participants and their resulting infants/live births are included.||participants|||Number
813127|NCT01077024|Secondary|Point-prevalence Abstinence (Smoking Outcome) 6 Month Visit|point-prevalence abstinence defined as not smoking in the previous seven days based on self-report and confirmed with a Carbon Monoxide (CO) level ≤ 8 ppm|6 month visit|||percentage of participants|||Number
813128|NCT01077024|Secondary|Stimulant-free Results at 6-month Visit|At the 6-month follow-up visit, percentage of participants with a negative urine drug screen for stimulant use and no stimulant use days reported during the past 28 days based on Timeline Follow-back.|6 - months follow-up visit|This outcome was only compared for participants who attended the 6-month follow-up visit (n=210 and n=218, respectively).||percentage of participants|||Number
813130|NCT01077024|Secondary|Stimulant-free Results at 3-month Visit|At the 3-month follow-up visit, percentage of participants with a negative urine drug screen for stimulant use and no stimulant use days reported during the past 28 days based on Timeline Follow-back.|3-month follow-up visit|This outcome was only compared for participants who attended the 3-month follow-up visit (n=226 and n=240, respectively).||percentage of participants|||Number
813131|NCT01077024|Secondary|Four Week Continuous Smoking Abstinence|A combination of daily self-reported smoking data and weekly carbon monoxide levels were used to determine continuous abstinence during post-quit days 15 – 42.|Post-quit days 15-42|||percentage of participants|||Number
813132|NCT01077024|Secondary|Point-prevalence Abstinence (Smoking Outcome)|point-prevalence abstinence defined as not smoking in the previous seven days based on self-report and confirmed with a Carbon Monoxide (CO) level ≤ 8 ppm|Week 10 assessment|||percentage of participants|||Number
813133|NCT01077024|Primary|Stimulant-free Weeks Assessed by Self-report and Twice-weekly Urine Drug Screens|Stimulant-free week results (no cocaine, methamphetamine and amphetamine use) were obtained by combining the urine drug screens (UDS) and the self-reported Timeline Follow-Back (TLFB). At the group level, this outcome translates into the percentage of weeks in each study arm that are stimulant-free.|Week 16|||percentage of weeks|||Number
813134|NCT01077050|Secondary|Sensitivity and Specificity|"Secondary confirmatory objective included two co-secondary endpoints that were defined similarly to the co-primary endpoints, but used the Secondary definition of dichotomous reference diagnosis.
Positive Reference Diagnosis: Melanoma, Squamous Cell Carcinoma, Basal Cell Carcinoma, Severe Dysplastic Nevus (High grade dysplasia)
Negative Reference Diagnosis: All other skin lesions."|Post data lock||08/2013||||
813135|NCT01077050|Primary|SciBase Sensitivity and Specificity|"This study has two co-primary objectives, aiming to demonstrate the accuracy of SciBase device:
Sensitivity ≥ 0.90 to detect Melanoma
Sensitivity – (1-Specificity) > 0.00
Sensitivity is the proportion of correctly identified cases of Melanoma. Specificity is the proportion of correctly identified cases of non-melanoma."|Post data lock|Biopsied Skin Lesions||Percentage of total lesions|Participants|95% Confidence Interval|Mean
813136|NCT01077063|Primary|Safety of Pleurx Catheter or Paracentesis|"Primary Outcome: Safety of the Pleurx catheter procedure or paracentesis
Safety of the pleurx catheter procedure or paracentesis. Safety will be assessed by the degree of unacceptable toxicities, defined as life threatening complications related to the procedure. These include peritonitis, perforation, or death related to the procedure."|3 years|||events|||Number
813137|NCT01077076|Primary|Percent Time With Intragastric pH>4 During the First 4 Hours Following Administration on Day 4 of Treatment|Early effectiveness of treatment is evaluated as the percent time with intragastric pH>4 during the first 4 hours following administration of respective treatments|4 hours after dose on Day 4|"Pharmacodynamic-Evaluable Population: All participants who presented valid data from all three study periods.
One participant was dropped from the Pharmacodynamic-Evaluable Population in the Prilosec OTC Tablets group because of invalid pH tracings at Day 4. Therefore, the number of participants included at Day 4 in this group was 26."||Percentage of Time||Standard Deviation|Mean
813138|NCT01077128|Secondary|Assessment of Long Term Use and Safety of Adalimumab as Prescribed by the Dermatologist in a Normal Clinical Setting and in Accordance With the Terms of the European Marketing Authorization|An adverse event (AE) was defined as any untoward medical occurrence in a participant, which did not necessarily have a causal relationship with their treatment. Any worsening of a pre-existing condition or illness was considered an adverse event.|12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)|||Participants|||Number
813139|NCT01077128|Secondary|Mean Change From Baseline of European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Visual Analogue Scale (VAS) Scores|"EQ-5D (European Quality of Life - 5 Dimensions Questionnaire) is a standardized instrument for use as a measure of health outcome.
It has two components:
the EQ-5D descriptive system (i.e., the EQ-5D Index Score, comprised of five items), and
the EQ-5D VAS. EQ-5D Index Score has five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Patients reported either “problem” or “no problem” with each of the five dimensions of health. The EQ-5D VAS is a 20-cm scale with endpoints labeled best imaginable health and worst imaginable health anchored at 100 and 0, respectively."|12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)|Participants with available data at each time point||units on a scale||Standard Deviation|Mean
813140|NCT01077128|Secondary|"Percentage of Patients Reporting No Problem on the European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D)"|"EQ-5D (European Quality of Life - 5 Dimensions Questionnaire) is a standardized instrument for use as a measure of health outcome.
It has two components:
the EQ-5D descriptive system (i.e., the EQ-5D Index Score, comprised of five items), and
the EQ-5D VAS. The EQ-5D Index Score has five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Patients reported either “problem” or “no problem” with each of the five dimensions of health. The EQ-5D VAS is a 20-cm scale with endpoints labeled best imaginable health and worst imaginable health anchored at 100 and 0, respectively."|12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)|Participants with available data at each time point||Percentage of patients with no problem|||Number
813141|NCT01077128|Secondary|Mean Change in the Dermatology Life Quality Index (DLQI) Score by Physician’s Global Assessment of Disease Severity (PGA) Response Groups and by Geographical Region|The average change in the Dermatology Life Quality Index (DLQI) score during the 12-month study was analyzed by the Physician’s Global Assessment of disease severity (PGA) response and also by geographical location of study participants. DLQI scores range from 0 to 30, with a higher score indicating a more impaired quality of life. . In this table, a higher number means a greater improvement in the participants’ quality of life.|12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)|Participants with available data at each time point||units on a scale||Standard Deviation|Mean
813142|NCT01077128|Secondary|Percentage of Patients Who Experienced an Improvement in Disease Severity as Determined by the Physician’s Global Assessment of Disease Severity (PGA) Scores|The Physician's Global Assessment of disease severity (PGA) was used to measure participants’ disease status at the time of assessment. This tool is a horizontal visual analogue 6-point scale measuring the degree of overall psoriatic lesion severity, and scores range from 0 (clear) to 5 (very severe). The percentage of patients who showed an improvement from baseline in their PGA scores was recorded.|12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)|Participants with available data at each time point||Percentage of patients improving|||Number
813143|NCT01077128|Primary|Mean Change of Dermatology Life Quality Index (DLQI) Scores|DLQI (Dermatology Life Quality Index) assesses symptoms and impacts of dermatologic diseases on quality of life. DLQI scores range from 0 to 30, with a higher score indicating a more impaired quality of life.|12-month period, (Month 0, Month 1, Month 4, Month 8, Month 12)|Participants with available data at each time point||units on a scale||Standard Deviation|Mean
813144|NCT01077193|Primary|Mean Percent Excess Weight Loss at 3 Years With Last Observation Carried Forward|"Percent excess weight change from baseline to 3 years was calculated as (the baseline weight minus the weight at 3 years) divided by the (baseline weight minus the ideal body weight (using the upper limit of the midpoint range in the Metropolitan Tables for Life Insurance, 1983) x 100). Last observation carried forward was used for early terminated subjects.
One-sided, alpha=0.025, t-test of the Percent Excess Weight Loss (EWL) at 3-years to demonstrate non-inferiority to the target weight loss value of 41.1%EWL"|3 years|||percentage of baseline excess weight||Standard Deviation|Mean
813145|NCT01077258|Secondary|Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication||Baseline and Months 3, 6, 9, 12, 18, and 24|Full analysis set with available data at each time point (indicated by n)||percentage of participants|||Number
813146|NCT01077258|Secondary|Percentage of Participants With In-patient Hospitalization|The percentage of participants with in-patient hospitalization in the prior 6 months. Baseline data includes in-patient hospitalizations that occurred within the prior 12 months.|Month 6, 12, 18, and 24|Full analysis set with available data at each time point (indicated by n)||percentage of participants|||Number
813147|NCT01077258|Secondary|Number of Days Missed From Work Due to Rheumatoid Arthritis|Participants reported the number of days they had missed from work in the prior 6 months. The Baseline measurement includes data for the prior 12 months.|Baseline and Months 6, 12, 18, and 24|Full analysis set participants who were employed and with available data at each time point (indicated by n)||days||Standard Deviation|Mean
813148|NCT01077258|Secondary|Percentage of Participants With Impairment in Daily Activities|Participants were asked to report how many days of impairment in daily activities they had experienced in the last 4 weeks.|Baseline and Months 3, 6, 9, 18, and 24|Full analysis set with available data at each time point||percentage of participants|||Number
813149|NCT01077258|Secondary|Participants Assessment of Pain Over Time|Participants indicated their level of pain over the last 7 days on a visual analog scale (VAS) from 0 (best) to 10 (worst) cm; lower scores indicate better patient status.|Baseline and Months 3, 6, 9, 12, 18, and 24|Full analysis set with available data at each time point (indicated by n)||cm||Standard Deviation|Mean
813150|NCT01077258|Secondary|Participants Assessment of Fatigue Over Time|Participants indicated their level of fatigue over the last 7 days on a visual analog scale (VAS) from 0 (best) to 10 (worst) cm; lower scores indicate better patient status.|Baseline and Month 3, 6, 9, 12, 18, and 24|Full analysis set with available data at each time point (indicated by n)||cm||Standard Deviation|Mean
813151|NCT01077258|Secondary|Patients Global Assessment of Disease Activity Over Time|Participants indicated their global assessment of disease activity over the last 7 days on a visual analog scale (VAS) from 0 (best) to 10 (worst) cm; lower scores indicate better patient status.|Baseline and Months 3, 6, 9, 12, 18 and 24|Full analysis set with available data at each time point (indicated by n)||cm||Standard Deviation|Mean
813152|NCT01077258|Secondary|Hannover Functional Questionnaire (FFbH) Over Time|"A self-administered patient questionnaire used to assess patient function based on 18 questions. The numerically coded responses to the questions are added to provide a total patient score. The FFbH was calculated from this patient score by the following formula:
FFbH = (patient score x 100) ÷ 2 (number of valid responses). The resulting FFbH score reflects the degree of remaining functional capacity where 0 indicates maximal impairment and 100 indicates maximal functional capacity."|Baseline and Months 3, 6, 9, 12, 18, and 24|Full analysis set with available data at each time point (indicated by n)||units on a scale||Standard Deviation|Mean
813153|NCT01077258|Secondary|Swollen Joint Count (SJC) Over Time|Twenty-eight joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination.|Baseline and Months 3, 6, 9, 12, 18, and 24|Full analysis set with available data at each time point (indicated by n)||swollen joints||Standard Deviation|Mean
813154|NCT01077258|Secondary|Tender Joint Count (TJC) Over Time|Twenty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination.|Baseline and Months 3, 6, 9, 12, 18, and 24|Full analysis set with available data at each time point (indicated by n)||tender joints||Standard Deviation|Mean
813155|NCT01077258|Secondary|C-Reactive Protein (CRP) Levels Over Time|C-Reactive Protein (CRP) was measured from blood samples as a marker for inflammation. Higher levels are indicative of more inflammation. Normal concentration in healthy human serum is usually lower than 10 mg/L, slightly increasing with age.|Baseline and Months 3, 6, 9, 12, 18, and 24|Full analysis set with available data at each time point (indicated by n)||mg/L||Standard Deviation|Mean
813156|NCT01077258|Secondary|Erythrocyte Sedimentation Rate (ESR) Over Time|Erythrocyte sedimentation rate (ESR) indirectly measures how much inflammation is in the body. A higher ESR is indicative of increased inflammation.|Baseline and Months 3, 6, 9, 12, 18, and 24|Full analysis set with available data at each time point (indicated by n)||mm/hour||Standard Deviation|Mean
813157|NCT01077258|Secondary|Percentage of Participants With Low, Moderate and High Disease Activity|"The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (assessed on a visual analog scale [VAS] from 0 to 10 cm) are included in the DAS28. If the ESR value is missing, the C-reactive protein (CRP) value can be substituted. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity.
Low disease activity is defined as a DAS28 score ≤ 3.2; Moderate disease activity as a DAS28 >3.2 to ≤5.1; High disease activity as a DAS28 >5.1."|Baseline and Months 3, 6, 9, 12, 18, and 24|Full analysis set with available data at each time point||percentage of participants|||Number
813169|NCT01077284|Secondary|Change From Baseline to Month 6 in the Number of Calcium Oxalate Stones|Multidetector Computed Tomography (MDCT) was used to visualize and count calcium oxalate kidney stones at Baseline and after 6 months of treatment. All MDCT images were analyzed independently by a Central Reader.|Baseline and Month 6|Full analysis set for whom both Baseline and Month 6 MDCT data were available. Measurements more than 1 day after a patient’s last dose of study drug were not included.||stones||Standard Deviation|Mean
813158|NCT01077258|Secondary|Percentage of Participants With a Significant Therapeutic Response|"Significant therapeutic response was determined by DAS28 critical difference (Dcrit). A Dcrit response is a statistically determined value that exceeds the threshold of random fluctuation and signifies a positive individual response during treatment. A DAS28-Dcrit individual therapeutic response is defined as a decrease (improvement) in DAS28 from Baseline of ≥ 1.8.
The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (assessed on a visual analog scale [VAS] from 0 to 10 cm) are included in the DAS28. If the ESR value is missing, the C-reactive protein (CRP) value can be substituted. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity."|Baseline and Months 3, 6, 9, 12, 18, and 24|Full analysis set with available data at each time point (indicated by n)||percentage of participants|||Number
813159|NCT01077258|Primary|Percentage of Participants in DAS28 Remission|Clinical remission is defined as a disease activity score (DAS) 28 score of < 2.6. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR), and the patient’s assessment of global disease activity (assessed on a visual analog scale [VAS] from 0 to 10 cm) are included in the DAS28. If the ESR value is missing, the C-reactive protein (CRP) value can be substituted. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity.|Months 3, 6, 9, 12, 18, and 24|Full analysis set with available data at each time point (indicated by n)||percentage of participants|||Number
813160|NCT01077258|Primary|Change From Baseline in Disease Activity Score (DAS) 28|The Disease Activity Score 28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (on a visual analog scale [VAS] from 0 to 10 cm) are included in the DAS28 score. If the ESR value is missing, the C-reactive protein (CRP) value can be substituted. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.|Baseline and Months 3, 6, 9, 12, 18, and 24|"Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. n indicates the number of participants with available data at each time point."||units on a scale||Standard Deviation|Mean
813161|NCT01077271|Secondary|Effectiveness of Palivizumab at the End of the Observation Period is Checked by the Physician by Ranking in a Visible Analog Scale|The therapeutic effect of palivizumab was assessed by the treating physician using a visual analog scale from 0 to 10, where 0 indicated that palivizumab did not match expectations at all and 10 indicated that palivizumab met all expectations. The physician rated palivizumab treatment for each participant at the last study visit (LSV) or, in the case of participants withdrawing from the study, at the early termination (ET) visit.|One RSV season (5 months), end of study|The analysis included participants who were administered palivizumab and had data available for the study visits listed. A total of 100 participants were rated at the last study visit; 2 did not have ratings. A total of 18 participants who discontinued from the study were rated at the early termination visit.||units on a scale||Standard Deviation|Mean
813162|NCT01077271|Secondary|Parents Knowledge of Burden of RSV Disease Via Interview by Physician|"An informational brochure was given to parents of participants. Parents were interviewed by the treating physician at the first study visit (V1) and last study visit (LSV) (or early termination visit [ET]) for those participants discontinuing from the study). Parental knowledge of the burden of respiratory syncytial virus (RSV) disease was assessed using a questionnaire. Parents were considered to have “good RSV awareness if all questions were answered and at least 3 of the 4 questions regarding the burden of RSV disease were answered correctly."|One RSV season (5 months)|The analysis included parents of participants who were administered and had data available for the study visits listed.||Parents of participants|||Number
813163|NCT01077271|Secondary|Assessment of Pain During Injection According to Pain Scores (VAS and Modified Behavioral Pain Scale)|The clinician who administered the palivizumab injection was asked to rate pain during injection using a visual analog scale (VAS) and the Modified Behavior Pain Scale (MBPS) as published by Carbajal et al., 2008. The VAS ranged from 0 (no pain) to 100 (maximum pain). The Modified Behavioral Pain Scale ranged from 0 (no pain) to 10 (maximum pain) through the evaluation of 3 items: Facial expressions, cry, and movements. If more than one injection was given at a visit, then the first injection was rated.|One RSV season (5 months)|The analysis included participants who were administered palivizumab and had data available for the study visits listed.||units on a scale||Standard Deviation|Mean
813164|NCT01077271|Primary|Dosage Per Administration|The median dose and range of palivizumab (milligrams) that was administered at each study visit.|One RSV season (5 months)|The analysis population includes participants who were administered palivizumab and had data available for the study visits listed.||milligrams||Full Range|Median
813165|NCT01077271|Primary|Interval Between Administrations|The average number of days that elapsed between palivizumab injections administered at the previous study visit.|One RSV season (5 months)|The analysis population includes participants who were administered palivizumab and had data available for the study visits listed.||Days||Standard Deviation|Mean
813166|NCT01077271|Primary|Body Site of Injections Per Administration|The body site of injection administration for participants at each study visit.|One RSV season (5 months)|The analysis population includes participants who were administered palivizumab and had data available for the study visits listed.||participants|||Number
813167|NCT01077271|Primary|Number of Injections Per Patient Per Season|The average number of injections administered per participant within a respiratory syncytial virus season.|One RSV season (5 months)|Participants who were administered palivizumab were included in the analysis.||Injections administered||Standard Deviation|Mean
813168|NCT01077284|Secondary|Change From Baseline to Month 6 in 24-hour Measured Creatinine Clearance|Creatinine clearance is a measure of how well the kidneys are filtering creatinine, a waste product produced by the muscles. Measured creatinine clearance was calculated according to the following: Urine 24 hour Creatinine/Serum Creatinine x (total Urine volume/elapsed time) x (1.73/body surface area).|Baseline and Month 6|Full analysis set. Missing Month 6 Visit 24-hour mCLcr values are imputed by Month 3 values if the Month 3 value was available otherwise the patient was excluded from the analysis.||mL/min/1.73m²||Standard Deviation|Mean
813170|NCT01077284|Secondary|Percent Change From Baseline to Month 6 in the In-plane Diameter of the Largest Calcium Oxalate (CaOx) Stone|Multidetector Computed Tomography (MDCT) was used to visualize and measure calcium oxalate kidney stones at Baseline and after 6 months of treatment. All MDCT images were analyzed independently by a Central Reader. The change from Baseline to month 6 is expressed as a percentage of the Baseline largest in-plane diameter.|Baseline and Month 6|Full analysis set, for whom Baseline and Month 6 MDCT data were available. Measurements more than 1-day after a patient's last dose of study drug were not included.||percent change||Standard Deviation|Mean
813171|NCT01077284|Primary|Percent Change From Baseline to Month 6 in 24-hour Urine Uric Acid (uUA) Excretion|The change from Baseline to Month 6 in 24-hour urine uric acid is expressed as a percentage of the Baseline uUA value.|Baseline and Month 6|The full analysis set (patients who took at least 1 dose of double-blind study drug and had a baseline 24-hour uUA >700 mg and at least 1 kidney CaOx stone ≥3 mm in its longest inplane diameter). Missing Month 6 values were imputed with baseline values if patient discontinued due to an AE; or otherwise with the last available post-baseline value.||percent change||Standard Deviation|Mean
813172|NCT01077310|Other Pre-specified|Mean Change in CD4 Cell Count (Cells/mL)|Baseline labs will be drawn while subjects is in prison, one to three months prior to release. Additionally, blood will be drawn every 3 months for 1 year to monitor changes in CD4 cell count.|Baseline and every 3 months for 1 year|These data were not able to be collected for analysis.|||||
813173|NCT01077310|Secondary|Alcohol Treatment Outcome: Change in Percent of Heavy Drinking Days|change in the percent of heavy drinking days from 12 weeks prior to incarceration to 6 months post release from incarceration.|change in percent of heavy drinking days12 weeks prior to release from prison (baseline), day of release, to 6 months post-release|||percent of heavy drinking days||Standard Deviation|Mean
813174|NCT01077310|Secondary|Alcohol Treatment Outcome: Change in Average Drinks Per Drinking Day|The mean change from 12 weeks pre incarceration to 6 months post release from incarceration in average drinks per drinking day|12 weeks prior to release from prison (baseline) to 6 months post release|||standard units of alcohol||Standard Deviation|Mean
813175|NCT01077310|Secondary|Alcohol Treatment Outcome: Time to Alcohol Relapse|Self reported time to first heavy drinking day after release from incarceration, up to 6 months|Post release|||days||Standard Deviation|Mean
813176|NCT01077310|Primary|Percentage of Those Maintain or Improve to HIV RNA-1 Viral Load Less Then 400 Copies/mL|Percentage of participants that maintained or improved a level of undetectable HIV viral load from baseline (closest viral load to time of release from incarceration) to 6 months post release. Missing lab values were considered to have a detectable HIV viral load.|Baseline to month 6 post release|Logistic regression backward stepwise models were used to find predictors of HIV viral suppression.||percent of participants|||Number
813177|NCT01077323|Primary|"Incidence Rates Per 100,000 Person-Years of Likely Acute Pancreatitis (During Past Use Period) - Time on Drug Analysis"|"Crude time-on-drug incidence rate per 100,000 person-years of likely acute pancreatitis in initiators of exenatide, initiators of other antidiabetic drugs and the non-diabetes cohort. Analysis period is past use period, described as time following recent use excluding subsequent current or recent use."|43 months|Time on Drug Analysis||Cases per 100,000 person-years||95% Confidence Interval|Number
813178|NCT01077323|Primary|"Incidence Rates Per 100,000 Person-Years of Likely Acute Pancreatitis (Among Recent Use Period) - Time on Drug Analysis"|"Crude time-on-drug incidence rate per 100,000 person-years of likely acute pancreatitis in initiators of exenatide, initiators of other antidiabetic drugs and the non-diabetes cohort. Analysis period is the recent use period, described as time following current use plus an additional 31 days excluding subsequent current use."|43 months|Time on Drug Analysis||Cases per 100,000 person-years||95% Confidence Interval|Number
813179|NCT01077323|Secondary|Incidence Rates Per 100,000 Person-Years of Likely Acute Pancreatitis Among Initiators of Exenatide, Diabetics Initiating Other Antidiabetic Drugs, and the Non-diabetes Cohort - Intent to Treat Analysis|Crude intent-to-treat incidence rate per 100,000 person-years of likely acute pancreatitis in initiators of exenatide, initiators of other antidiabetic drugs and the non-diabetes cohort.|43 months|Intent to Treat Analysis||Cases per 100,000 person-years||95% Confidence Interval|Number
813180|NCT01077323|Primary|"Incidence Rates Per 100,000 Person-Years of Likely Acute Pancreatitis (During Current Use Period) - Time on Drug Analysis"|"Crude time-on-drug incidence rate per 100,000 person-years of likely acute pancreatitis in initiators of exenatide, initiators of other antidiabetic drugs and the non-diabetes cohort. Analysis period is current use period, described as time during current day's supply plus 31 days."|43 months|Time on Drug Analysis||Cases per 100,000 person-years||95% Confidence Interval|Number
813181|NCT01077362|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 70 Response at Week 24|"An ACR 70 response is defined as a greater than or equal to 70 percent improvement from baseline in swollen (66 joints) and tender (68 joints) joint counts and greater than or equal to 70 percent improvement in 3 of the following 5 assessments: 1) Participant's assessment of pain by Visual Analog Scale (VAS) (0-10 cm), 2) Participant's global assessment of disease activity by VAS (0-10 cm), 3) Physician's global assessment of disease activity by VAS (0-10 cm) 4) Participant's assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas) and 5) C reactive protein."|Week 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment. For early escaped, data at or prior to Week 16 were carried forward through Week 24.||Percentage of participants|||Number
813192|NCT01070888|Primary|Mean Difference Between Maximal Percentage Decrease in FEV1 After the Exercise Challenge Compared to the Run in Period, Budesonide/Formoterol - Budesonide|"Mean difference between maximal percentage decrease in FEV1 after the exercise challenge compared to the run in period, budesonide/formoterol - budesonide, calculated as follows:
(max fall in FEV1(baseline) - maximal fall in FEV1(bud/form) - (max fall in FEV1(baseline) - maximal fall in FEV1(bud))"|8 weeks|||percentage of fall in FEV1||Standard Deviation|Mean
813193|NCT01070953|Primary|Overall Efficacy Evaluation of EZETROL®|Participants who received EZETROL over 4 weeks and then have been evaluated for overall efficacy assessment by investigator showing to be improved, unchanged or worsened.|Baseline to 4 weeks|3,309 subjects were analyzed for the efficacy evaluation; 227 of the enrolled subjects did not complete the study and were excluded||participants|||Number
831863|NCT01243320|Secondary|Change Systolic Blood Pressure|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days|||mmhg||95% Confidence Interval|Mean
813182|NCT01077362|Secondary|Change From Baseline to Week 24 in Total Modified Van Der Heijde-Sharp (vdH-S) Score for the Combined Radiographic Data From Studies CNTO1275PSA3001 and CNTO1275PSA3002|The modified vdH-S score is a radiographic evaluation of hand and feet erosions and joint space narrowing (JSN) for 20 joints per hand and 6 joints per foot with a total score ranging from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher scores and positive score changes indicate more radiographic damage and radiographic progression, respectively. As per protocol, the analysis for this outcome measure used pooled data from 2 studies (CNTO1275PSA3001 and PSA3002) because initial power assumptions showed that 900 participants would be required to evaluate the impact of ustekinumab on structural damage (SD) progression. The 2 studies, (which had similar study designs and dosing regimens and differed only with regards to prior exposure to anti-TNFα therapies), were intended to independently measure efficacy in terms of signs, symptoms and physical function, while effects on SD progression would be provided from an integrated analysis.|Day 1 (Baseline) and Week 24|Analysis included: (1) combined data from studies CNTO1275PSA3001 (NCT01009086) and CNTO1275PSA3002 (NCT01077362) and (2) all participants randomly assigned to a treatment group.||Score on a scale||Standard Deviation|Mean
813183|NCT01077362|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Week 24|"An ACR 50 response is defined as a greater than or equal to 50 percent improvement from baseline in swollen (66 joints) and tender (68 joints) joint counts and greater than or equal to 50 percent improvement in 3 of the following 5 assessments: 1) Participant's assessment of pain by Visual Analog Scale (VAS) (0-10 cm), 2) Participant's global assessment of disease activity by VAS (0-10 cm), 3) Physician's global assessment of disease activity by VAS (0-10 cm) 4) Participant's assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas) and 5) C reactive protein."|Week 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment. For early escape, data at or prior to Week 16 were carried forward through Week 24.||Percentage of participants|||Number
813184|NCT01077362|Secondary|Percentage of Participants (With >= 3% Baseline Body Surface Area (BSA) Psoriatic Involvement) Who Achieved a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 24|The PASI is a physician-administered assessment tool used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). A PASI 75 response is defined as greater than or equal to 75 percent improvement in PASI score from baseline.|Week 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment. For early escape, data at or prior to Week 16 were carried forward through Week 24. Only participants with >=3% baseline BSA psoriatic involvement were included in this analysis.||Percentage of participants|||Number
813185|NCT01077362|Secondary|"Change From Baseline to Week 24 in the Disability Index Score as Measured With the Disability Index of the Health Assessment Questionnaire (HAQ-DI)"|HAQ-DI is 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0 (no difficulty), to 3 (inability to perform a task in that area). The average score across the functional areas yields an overall HAQ-DI score which ranges from 0 (no disability) to 3 (completely disabled). In psoriatic arthritis, a decrease in score of 0.30 indicates clinically meaningful improvement.|Day 1 (Baseline) and Week 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment. For early escape, data at or prior to Week 16 were carried forward through Week 24.||Score on a scale||Standard Deviation|Mean
813186|NCT01077362|Primary|Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 24.|"An ACR 20 response is defined as a greater than or equal to 20 percent improvement from baseline in swollen (66 joints) and tender (68 joints) joint counts and greater than or equal to 20 percent improvement in 3 of the following 5 assessments: 1) Participant's assessment of pain by Visual Analog Scale (VAS) (0-10 cm), 2) Participant's global assessment of disease activity by VAS (0-10 cm), 3) Physician's global assessment of disease activity by VAS (0-10 cm) 4) Participant's assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas) and 5) C reactive protein."|Week 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment. For early escape, data at or prior to Week 16 were carried forward through Week 24.||Percentage of participants|||Number
813187|NCT01077375|Secondary|Change From Baseline to Visit 5 (Week 13) in the Visual Analog Scale (VAS) 1-week Pain Recall Score|The VAS assessment ranges from a scale of 0 (no pain) to 100 (worst possible pain).|Change from Baseline (Week 3) to Visit 5 (Week 13)|ITT Population: patients in the Double-blind Safety Population with ≥ 1 PGIC post-baseline assessment. Double-blind Safety Population includes 6 patients who were not included in ITT population. Presented results generated via LOCF approach. No statistical comparisons between groups are presented; study was exploratory, not hypothesis-testing.||Units on a scale||Standard Deviation|Mean
813188|NCT01077375|Primary|Responder Status Based on Patient Global Impression of Change (PGIC) Score at Visit 5 (Week 13)|The PGIC is a patient-reported measure of improvement in pain sensation and quality of life scored on a scale from 1 (very much improved) to 7 (very much worse). To meet the criteria for a responder in this study, patients must report a score of 1 (very much improved) or 2 (much improved) on the PGIC.|Assessed at Visit 4 (Week 9) and Visit 5 (Week 13) or early termination. Presented results generated via LOCF approach.|ITT Population: patients in the Double-blind Safety Population with ≥ 1 PGIC post-baseline assessment. Double-blind Safety Population includes 6 patients who were not included in ITT population. Presented results generated via LOCF approach. No statistical comparisons between groups are presented; study was exploratory, not hypothesis-testing.||participants|||Number
813189|NCT01077401|Secondary|Mean Change in Retinal Thickness at Month 6||baseline to6 Months|Data was not collected for 4 participants in the Ranibizumab 0.5mg group for this outcome measure.||µm||Standard Deviation|Mean
813190|NCT01077401|Secondary|Mean Change in Best Corrected Visual Acuity From Baseline to Month 6|Mean change in best corrected visual acuity (BCVA) (ETDRS) at 4 meters in the study eye over time through month 6.|baseline 6 Months|||letters||Standard Deviation|Mean
813191|NCT01077401|Primary|Deaths Due to Myocardial Infarction||6 Months|||participants|||Number
813194|NCT01070953|Primary|Mean Percent Change From Baseline to Treatment in Lipid Parameters|The mean percent change from baseline to treatment in lipid parameters (total cholesterol [TC], low-density lipoprotein [LDL] cholesterol, high-density lipoprotein [HDL] cholesterol, triglycerides[TG]) in participants who received EZETROL over 4 weeks and then had available laboratory results in Lipid Parameters.|Baseline to 4 weeks|"3,309 subjects were analyzed for the efficacy
evaluation; 227 of the enrolled subjects did not complete the study and were excluded"||percentage of change||Standard Deviation|Mean
813195|NCT01070953|Primary|Participants With Any Clinical and/or Laboratory Adverse Experience While Being Treated With EZETROL® Within 14 Days After Treatment Discontinuation|Participants who recieved EZETROL® and experienced any adverse event related or unrelated to EZETROL®, within 14 days after treatment.|Up to 14 days after treatment discontinuation|||participants|||Number
813196|NCT01070966|Primary|Mean Percent Change From Baseline to Treatment in Lipid Parameters|The mean percent change from baseline to treatment in lipid parameters (total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, triglycerides[TG]) and overall efficacy was evaluated by the investigator to show if there was any(improved, unchanged, worsened) lipid parameters over a period of approximately 5 years.|Baseline and up to 5 years|||percentage change||Standard Deviation|Mean
813197|NCT01070966|Primary|Percentage of Participants With Any Clinical and/or Laboratory Adverse Experiences While Taking VYTORIN® Within 14 Days After Treatment Discontinuation|Participants who recieved VYTORIN and experienced any adverse event related or unrelated to VYTORIN®, within 14 days after treatment.|Up to 14 days after the treatment discontinuation|||Percentage of Participants|||Number
813198|NCT01070979|Secondary|Change From Baseline in Total Urogenital Symptom Score, Week 12, ITT Population|Urogenital Symptom Severity scored none=0, mild=1, moderate=2, severe=3.|Baseline to Week 12|Intention to Treat (ITT) with Last Observation Carried Forward (LOCF)||Change in Score||Standard Error|Least Squares Mean
813199|NCT01070979|Secondary|Change From Baseline in Total Urogenital Symptom Score, Week 8, ITT Population|Urogenital Symptom Severity scored none=0, mild=1, moderate=2, severe=3.|Baseline to Week 8|Intention to Treat (ITT) with Last Observation Carried Forward (LOCF)||Change in Score||Standard Error|Least Squares Mean
813200|NCT01070979|Secondary|Mean Change From Baseline in Total Urogenital Symptom Score, Week 4, ITT Population|Urogenital Symptom Severity scored none=0, mild=1, moderate=2, severe=3.|Baseline to Week 4|Intention to Treat (ITT) with Last Observation Carried Forward (LOCF)||Change in Score||Standard Error|Least Squares Mean
813201|NCT01070979|Secondary|Mean Change From Baseline in the Severity of Moderate to Severe Hot Flushes, Week 12, ITT Population|Patient self-reported outcome. Severity of hot flush definitions: mild (1) - sensation of heat without perspiration, moderate (2) - sensation of heat with perspiration, able to continue activity, severe (3) - sensation of heat with perspiration, causing the subject to stop activity or awaken from sleep. Minimum 0/no hot flushes, Maximum 3/all severe hot flushes. Lower the score the greater the improvement in reducing hot flushes.|Baseline to Week 12|Intention to Treat (ITT) with Last Observation Carried Forward (LOCF)||Change in Score||Standard Error|Least Squares Mean
813202|NCT01070979|Primary|Mean Change From Baseline in the Number of Moderate to Severe Hot Flushes, Week 12, ITT Population|Severity of hot flush definitions: mild - sensation of heat without perspiration, moderate - sensation of heat with perspiration, able to continue activity, severe - sensation of heat with perspiration, causing the subject to stop activity or awaken from sleep|Baseline to Week 12|Intention to Treat (ITT) with Last Observation Carried Forward (LOCF)||Change in Hot Flush Count||Standard Error|Least Squares Mean
813203|NCT01070979|Secondary|Mean Change From Baseline in the Severity of Moderate to Severe Hot Flushes, Week 4, ITT Population|Patient self-reported outcome. Severity of hot flush definitions: mild (1) - sensation of heat without perspiration, moderate (2) - sensation of heat with perspiration, able to continue activity, severe (3) - sensation of heat with perspiration, causing the subject to stop activity or awaken from sleep. Minimum 0/no hot flushes, Maximum 3/all severe hot flushes. Lower the score the greater the improvement in reducing hot flushes.|Baseline to Week 4|Intention to Treat (ITT) with Last Observation Carried Forward (LOCF)||Change in Score||Standard Error|Least Squares Mean
813204|NCT01070979|Primary|Mean Change From Baseline in the Number of Moderate to Severe Hot Flushes, Week 4, ITT (Intention to Treat) Population|Severity of hot flush definitions: mild - sensation of heat without perspiration, moderate - sensation of heat with perspiration, able to continue activity, severe - sensation of heat with perspiration, causing the subject to stop activity or awaken from sleep|Baseline to Week 4|Intention to Treat (ITT) with Last Observation Carried Forward (LOCF)||Change in Hot Flush Count||Standard Error|Least Squares Mean
813205|NCT01071044|Secondary|Clinical Global Impression (Severity)|The Clinical Global Impression (Severity) is a one-item clinician-rated measure. The item is a likert scale on which the clinician rates the subject based on perceived severity of psychopathology, with higher numbers indicating higher severity. In this study, we compared the mean change in severity from baseline to endpoint.|Every visit|All participants were included in the analysis.||Scores on a scale||Standard Deviation|Mean
813206|NCT01071044|Secondary|Attention-Deficit Hyperactivity Disorder Rating Scale (ADHD-RS)|The Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) is an 18-item scale based on DSM-IV criteria for ADHD. Each item is rated using a likert scale from 0 (none) to 3 (severe), with a total score range of 0-54, with higher scores indicating more symptoms/severity. In this study, we compared mean change in ADHD-RS total score from baseline to endpoint of the study.|Every 2 weeks|All participants were included in the analysis.||Scores on a scale||Standard Deviation|Mean
813207|NCT01071044|Secondary|Fibromyalgia Impact Questionnaire (FIQ)|"The Fibromyalgia Impact Questionnaire (FIQ) is an assessment that quantifies the impact of fibromyalgia on an individual, including questions on pain level, fatigue, sleep disturbance, and psychological distress, among others. The score range is 0 to 100, with higher number indicating higher Fibromyalgia severity/impact.
Below, we compare the mean change in the Fibromyalgia Impact Questionnaire (FIQ) from baseline to week 6 between LDX and placebo treated patients."|Every 2 weeks|All participants were included in the analysis.||Scores on a scale||Standard Deviation|Mean
813237|NCT01071200|Secondary|Mean Total Number of Retrieved Oocytes|Mean number of oocytes retrieved on the day of ovum pick up (OPU) was counted. Oocyte retrieval is a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body.|34-36 hours post-hCG (OPU)|mITT population included all randomized participants who entered in the experimental phase at S8.||oocytes||Standard Deviation|Mean
813208|NCT01071044|Secondary|Short Form McGill Pain Questionnaire|The McGill Pain Questionniare (Short Form) consists of 15 pain descriptors (11 sensory; 4 affective) which are rated on an intensity scale. 0 = none, 1 = mild, 2 = moderate or 3 = severe. The sum of the intensity scores of the words chosen for sensory, affective and total descriptors are added for a total score. The score range is 0-45. In this study, we compared the change in the Short Form McGill Pain Questionnaire (SF-MPQ) from baseline to week 6 between LDX and placebo treated patients.|Every 2 weeks|All participants were included in analysis.||Scores on a scale||Standard Deviation|Mean
813209|NCT01071044|Secondary|Hamiliton Anxiety Inventory|The Hamilton Anxiety Scale is a 14-items clinician-rated scale designed to measure anxiety severity. Each of the 14 items is scored from 0 (symptom not persent) to 4 (severe symptom). The total range is 0-56. A total score of less than 17 indicates mild severity, 18-24 indicates mild to moderate severity, and a score of 25-30 indicates moderate to severe symptoms. In this study, we compared the mean change in the Hamilton Anxiety scale from baseline to week 6 between LDX and placebo-treated patients.|Every 2 weeks|All participants were included in the analysis.||Scores on a scale||Standard Deviation|Mean
813210|NCT01071044|Secondary|Fatigue Severity Scale (FSS)|The Fatigue Severity Scale is designed to measure the impact of fatigue on the life of the subject. It is a nine-question likert scale survey with a raw score range of 0-63. Scores of 36 and above indicate significant fatigue. In this study, we compared the mean change in the Fatigue Severity Scale (FSS) from baseline to endpoint between LDX and placebo treated patients.|Every 2 weeks|All participants were included in the analysis.||Scores on a scale||Standard Deviation|Mean
813211|NCT01071044|Primary|BRIEF-A|The BRIEF-A (Behavior Rating Inventory of Executive Function-- Adult Form) is comprised of the following sub-scales: Metacognition Index, Behavioral Regulation Index, Inhibit, Shift, Emotional Control, Self-Monitor, Initiate, Working Memory, Plan/Organize, Task Monitor, and Organziation of Material. These subscales are summed to provide the GEC or Global Executive Composite. Listed below are the mean improvement scores on the GEC index from baseline to endpoint. The Global Executive Composite raw score range is 70-182, with higher scores indicating more compromised executive functioning. The scores listed in the table depict mean improvement on the GEC from the beginning to the end of the study.|Every 2 weeks|All participants were included in the analysis.||Scores on a scale||Standard Deviation|Mean
813212|NCT01071070|Secondary|The Proportion of Subjects With 2 Consecutive Calcium Measurements Greater Than 11.0 mg/dL (2.75 mmol/L)|The number of subjects with (Yes) or without (No) two consecutive calcium measurements greater than 11.0 mg/dL (2.75 mmol/L)|Baseline to 12 weeks|The analysis was based on the intent-to-treat (ITT) population, which consisted of all randomized participants who received at least one dose of study drug.||participants|||Number
813213|NCT01071070|Secondary|The Change From Baseline to the Final Observation in the Vital Sign of Heart Rate||Baseline to 12 Weeks|The analysis was based on the intent-to-treat (ITT) population, which consisted of all randomized participants who received at least one dose of study drug.||beats per minute||Standard Deviation|Mean
813214|NCT01071070|Secondary|The Change From Baseline to the Final Observation in the Vital Sign of Diastolic Blood Pressure||Baseline to 12 Weeks|The analysis was based on the intent-to-treat (ITT) population, which consisted of all randomized participants who received at least one dose of study drug.||mm Hg||Standard Deviation|Mean
813215|NCT01071070|Secondary|The Change From Baseline to the Final Observation in the Vital Sign of Systolic Blood Pressure||Baseline to 12 Weeks|The analysis was based on the intent-to-treat (ITT) population, which consisted of all randomized participants who received at least one dose of study drug.||mm Hg||Standard Deviation|Mean
813216|NCT01071070|Secondary|The Change From Baseline to the Final Observation in Calcium-phosphorus Product||Baseline to 12 Weeks|The analysis was based on the intent-to-treat (ITT) population, which consisted of all randomized participants who received at least one dose of study drug.||mg^2/dL^2||Standard Error|Mean
813217|NCT01071070|Secondary|The Change From Baseline to the Final Observation in Calcium||Baseline to 12 Weeks|The analysis was based on the intent-to-treat (ITT) population, which consisted of all randomized participants who received at least one dose of study drug.||mg/dL||Standard Error|Mean
813218|NCT01071070|Secondary|The Change From Baseline to the Final Observation in Intact Parathyroid Hormone Value||Baseline to 12 Weeks|The analysis was based on the intent-to-treat (ITT) population, which consisted of all randomized participants who received at least one dose of study drug.||pg/mL||Standard Error|Mean
813219|NCT01071070|Secondary|The Proportion of Subjects Achieving a Final Intact Parathyroid Hormone Value Between 150 and 300 pg/mL|The number of subjects with (Yes) or without (No) final intact parathyroid hormone (iPTH) values between 150 and 300 pg/mL|Baseline to 12 Weeks|The analysis was based on the intent-to-treat (ITT) population, which consisted of all randomized participants who received at least one dose of study drug.||participants|||Number
813220|NCT01071070|Primary|The Achievement of Two Consecutive Greater Than or Equal to 30% Decreases From Baseline Intact Parathyroid Hormone Levels|The number of participants who achieved (Yes) or did not achieve (No) two consecutive decreases of greater than or equal to 30% from baseline in intact parathyroid hormone (iPTH) values|Baseline to 12 Weeks|The analysis was based on the per-protocol population, which consisted of all randomized participants who completed at least 6 weeks of treatment and met the conditions that defined the per-protocol population.||participants|||Number
813221|NCT01071083|Secondary|Time Course to Return of Radiological Activity, as Measured by the Percentage of Subjects Who Met Magnetic Resonance Imaging (MRI) Rescue Criteria.|MRI rescue criteria were the presence of 1 new gadolinium-enhancing (Gd+) lesion of >0.8 cubic centimeters in volume or 2 or more Gd+ lesions of any size, according to the central MRI reader.|28 Weeks|Of the randomized subjects, data from 167 subjects were used in efficacy analyses. Eight subjects were excluded from the analyses: 3 subjects had major protocol deviations and 5 subjects discontinued study participation prior to Week 4 Visit.||Percentage of subjects meeting criteria|||Number
813236|NCT01071200|Secondary|Mean Number of Mature Oocytes (Metaphase II)|Mean number of metaphase II oocytes was counted for participants undergoing ovum pick up for IntraCytoplasmic Sperm Injection (ICSI). ICSI is a procedure in which a single spermatozoon is injected into the oocyte cytoplasm. Metaphase II stage of the oocyte was classified as the time at which the first polar body was observed microscopically. Metaphase II oocytes are a sub-group of the total number of oocytes.|34-36 hours post-hCG (OPU)|"mITT population included all randomized participants who entered in the experimental phase at S8. Here N represents those participants undergoing ICSI whose oocytes were assessed for maturity (Metaphase II) using a microscope."||Metaphase II Oocytes||Standard Deviation|Mean
813222|NCT01071083|Primary|Time Course to Return of Radiological and/or Clinical Evidence of Multiple Sclerosis Activity, as Measured by the Percentage of Subjects Who Met Magnetic Resonance Imaging (MRI) and/or Clinical Relapse Rescue Criteria.|Rescue criteria were: 1) central reader MRI finding of 1 new gadolinium-enhancing (Gd+) lesion of >0.8 cubic centimeters in volume or 2 or more Gd+ lesions of any size 2) clinical relapse. Clinical relapse was new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, as defined by: an increase of ≥1 grade in ≥2 functional scales of the Expanded Disability Status Scale (EDSS); an increase of ≥2 grades in 1 functional scale of the EDSS; or an increase of >0.5 in EDSS if the previous EDSS was ≤5.5, or ≥0.5 if the previous EDSS was >5.5|28 Weeks|Of the randomized subjects, data from 167 subjects were used in efficacy analyses. Eight subjects were excluded from the analyses: 3 subjects had major protocol deviations and 5 subjects discontinued study participation prior to Week 4 Visit.||Percentage of subjects meeting criteria|||Number
813223|NCT01071096|Secondary|Changes Between Inter-ictal (Baseline) Levels Between Responders and Non-responders|Only cytokines with a mean densimetric value 1.65 times the background grey value in a minimum of 3 patients were considered detectable. These are reported below. Values normalized to positive control array spots after background subtraction: C5/C5a, CD40 Ligand, Granulocyte Colony Stimulating Factor (G-CSF), Growth Regulated Oncogene(GRO)-alpha, Soluble Intercellular Adhesion Molecule (sICAM)-1, Interferon gamma (IFN-y), Interleukin(IL)-1alpha, 1beta, 1ra, 8, 16, 17E, & 23, Interferon Gamma-Induced Protein 10 (IP-10), Interferon-inducible T cell alpha chemoattractant (I-TAC), Macrophage Migration Inhibitory Factor (MIF), Serpin E1, and Regulated Upon Activation Normal T-cell Expressed (RANTES)|For OnabotulinumtoxinA and Saline treatment months 1, 2 and 3 at Baseline level (inter-ictal) and at onset of headache that is one degree worse than Baseline level and that will be treated with acute therapy|Number of Participants Analyzed is low due to some unusable samples and missing samples making comparison between months impossible. 5 Responders and 5 Non-Responders provided enough samples at all time points for comparisons.||Florescent Units (FU)||Standard Deviation|Mean
813224|NCT01071096|Secondary|Saliva CGRP Levels for OnabotulinumtoxinA Responders (Reduction of Headache Days Greater Than 30%) vs. Non-responders and Saline|Saliva samples collected at Baseline (at no headache or lowest level of headache), at headache attack directly before taking rescue medication and 2 hours after treating with rescue medication.|For OnabotulinumtoxinA and Saline treatment months 1, 2 and 3|||pmol/mg total protein||Standard Deviation|Mean
813225|NCT01071096|Secondary|Inter-ictal (Baseline) Levels of Saliva Calcitonin Gene-related Peptide (CGRP)|CGRP Level collected each month when subject did not have a headache or was at lowest pain level of headache that month.|Baseline levels collected for OnabotulinumtoxinA and Saline treatment during Months 1 through 7|||pmol/mg total protein||Standard Error|Mean
813226|NCT01071096|Primary|Change in Number of Headache Days Per Month From Baseline to Month 1 (M1), Month 1 to Month 2 (M2), and Month 2 to Month 3 (M3).|Baseline number of headache days per month collected historically at screening. Post-treatment number of headache days collected per month via diary.|Baseline (collected historically at screening) vs. Mo 1, Mo 1 vs. Mo 2, Mo 2 vs. Mo 3, Mo 3 vs. Mo 4, Mo 4 vs. Mo 5, Mo 5 vs. Mo 6, and Mo 6 vs. Mo 7|||days||Standard Deviation|Mean
813227|NCT01071096|Primary|Change in Number of Headache Days Per Month From Baseline (BL) to Months 1 Through 7.|Baseline number of headache days per month collected historically at screening. Post-treatment number of headache days collected per month via diary.|Baseline (collected historically at screening) versus (vs.) Month (Mo) 1, Mo 2, Mo 3, Mo 4, Mo 5, Mo 6, and Mo 7|||days||Standard Deviation|Mean
813228|NCT01071200|Secondary|Number of Cycles Cancelled Due to Risk of OHSS|OHSS is an exaggerated systemic response to ovarian stimulation characterized by a wide spectrum of clinical and laboratory manifestations. It is classified as mild, moderate or severe according to the degree of abdominal distention, ovarian enlargement and respiratory, haemodynamic and metabolic complications.|Baseline (S8) until 12-18 day post-hCG and/or Week 7|Safety population included all the randomized participants who received at least one dose of the study drug.||cycles|||Number
813229|NCT01071200|Secondary|Number of Participants With Ovarian Hyper Stimulation Syndrome (OHSS)|OHSS is an exaggerated systemic response to ovarian stimulation characterized by a wide spectrum of clinical and laboratory manifestations. It is classified as mild, moderate or severe according to the degree of abdominal distention, ovarian enlargement and respiratory, haemodynamic and metabolic complications.|Baseline (S8) until 12-18 day post-hCG and/or Week 7|Safety population included all the randomized participants who received at least one dose of the study drug.||participants|||Number
813230|NCT01071200|Secondary|Percentage of Participants With Implantation|Implantation is the attachment and subsequent penetration by the zona-free blastocyst (usually in the endometrium) that starts five to seven days after fertilization.|12-18 day post-hCG and/or Week 7|mITT population included all randomized participants who entered in the experimental phase at S8.||percentage of participants|||Number
813231|NCT01071200|Secondary|Percentage of Participants With Clinical Pregnancy|Clinical pregnancy is defined as pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It includes ectopic pregnancy.|12-18 day post-hCG and/or Week 7|mITT population included all randomized participants who entered in the experimental phase at S8.||percentage of participants|||Number
813232|NCT01071200|Secondary|Percentage of Participants With Pregnancy||12-18 day post-hCG and/or Week 7|mITT population included all randomized participants who entered in the experimental phase at S8.||percentage of participants|||Number
813233|NCT01071200|Secondary|Number of Transferred Embryos|Embryo transfer is the procedure in which one or more embryos are placed in the uterus or Fallopian tube.|Day 3 post-hCG (ET)|mITT population included all randomized participants who entered in the experimental phase at S8.||embryos|||Number
813234|NCT01071200|Secondary|Number of Obtained Embryos|Total number of obtained embryos with maximum 3 inseminated oocytes was calculated.|Day 3 post-hCG (Embryo transfer [ET])|mITT population included all randomized participants who entered in the experimental phase at S8.||embryos|||Number
813235|NCT01071200|Secondary|Fertilization Rate|Fertilization rate was measured as the ratio between number of fertilized oocytes and number of inseminated oocytes (maximum 3).|12-18 day post-hCG and/or Week 7|mITT population included all randomized participants who entered in the experimental phase at S8.||ratio||Standard Deviation|Mean
814962|NCT01092663|Primary|Fasting Glycogenolysis|Change from baseline in fasting glycogenolysis after 12 weeks of colesevelam alone or colesevelam plus sitagliptin treatment|baseline and 12 weeks|||umol per kg Fat-Free Mass (FFM) per min||Standard Deviation|Mean
813238|NCT01071200|Secondary|Change From Baseline in Oestradiol (E2) Levels at Human Choriogonadotropin (hCG) Day||Baseline (S8) and hCG day|"mITT population included all randomized participants who entered in the experimental phase at S8. Here “N” represents number of participants analyzed and n represents the number of participants with plasma E2 levels at specified time points for respective treatment groups."||picogram/milliter (pg/mL)||Standard Deviation|Mean
813239|NCT01071200|Secondary|Mean Number of Ovarian Stimulation Days||Baseline (S8) until hCG day|mITT population included all randomized participants who entered in the experimental phase at S8.||Days||Full Range|Mean
813240|NCT01071200|Secondary|Mean Total Follicle Stimulating Hormone (FSH) and Recombinant Human Luteinizing Hormone (r-hLH) Dose||Baseline (S8) until hCG day|mITT population included all randomized participants who entered in the experimental phase at S8.||IU||Standard Deviation|Mean
813241|NCT01071200|Primary|Total Dose of Follicular Stimulating Hormone (FSH) for Retrieved Oocytes||Baseline (Stimulation day 8 [S8]) until hCG day|"Modified intention-to-treat (mITT) population included all randomized participants who entered in the experimental phase at S8. Here N represents number of participants analyzed for this measure."||IU||Standard Deviation|Mean
813242|NCT01071252|Secondary|To Assess the Time to Relapse|Relapse is defined as the loss of at least 50% of the maximum PASI change from baseline achieved at any time before that visit and analyzed only for the active treatment groups.|37 weeks|The full analysis set (FAS), identical to the randomized set, also consisted of all randomized patients.||days||95% Confidence Interval|Median
813243|NCT01071252|Secondary|Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90)|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).|Week 2, 3, 5, 9, 13, 17, 21, 25, 29, 33, 37|The full analysis set (FAS), identical to the randomized set, also consisted of all randomized patients.||Percentage of Participants|||Number
813244|NCT01071252|Secondary|Percentage of Participants With Investigator’s Global Assessment (IGA) Response|IGA treatment response is defined as achievement of IGA 0 (clear) or 1 (almost clear) and improvement of at least 2 points on the IGA scale compare with baseline.|Week 2, 3, 5, 9, 13, 17, 21, 25, 29, 33, 37|The full analysis set (FAS), identical to the randomized set, also consisted of all randomized patients.||percentage of participants|||Number
813245|NCT01071252|Primary|Percentage of Participants of Reponders of Psoriasis Area and Severity Index (PASI) 75 Achievement at Week 13|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).|week 13|The full analysis set (FAS), identical to the randomized set, also consisted of all randomized patients.||percentage of participants|||Number
813246|NCT01071278|Secondary|Number of Participants Who Reported Adverse Events||Up to 22 weeks|||participants|||Number
813247|NCT01071278|Primary|Number of Participants With Lipid Panel Control|Lipid Panel Control was defined as achieving target for one or more of the following parameters: low-density lipoprotein cholesterol (LDL-C) at goal (<100mg/dL), high-density lipoprotein cholesterol (HDL-C) within normal range (40mg/dL for males and 50mg/dL for females), and/or triglycerides within normal range (≤ 150mg/dL).|From Visit 1 entrance evaluation (Week 0) to Visit 2 (between Weeks 8-22)|Results are for the Intent-to-Treat (ITT) Population. Information regarding the participation in a disease management program was not reported for 63 participants in the ITT Population.||participants|||Number
813248|NCT01071395|Secondary|Safety Monitoring Will be Operative Throughout the Study||18 months||||||
813249|NCT01071395|Secondary|Correlations Between Scale Values and Clinical Global Impressions-Severity (CGI-s) and Correlations Between Scale Changes and Clinical Global Impression of Change (CGI-c)||18 months||||||
813250|NCT01071395|Secondary|Correlations Among the Scales||18 months||||||
813251|NCT01071395|Secondary|If Sufficient Number Are Maintained on 200 mg/Day, Differences in Change Scores Between 200 mg/Day and 300 mg/Day Amantadine. (This Analysis Will be BL vs End of Study)||18 months||||||
813252|NCT01071395|Secondary|Change Score Differences Between Week 4 and 8 to Measure Stability of Scales Over Two Visits on Stable Doses of Amantadine or Placebo||18 months||||||
813253|NCT01071395|Secondary|Differences in Slope From Baseline (BL) to End of Study (Data Will Include the 4 Week Scores) Between Placebo and Amantadine to Determine Which Scales Demonstrate Sensitivity Across Time.||18 months||||||
813254|NCT01071395|Primary|The Investigators Will Assess Effect Size With Each Scale for Detecting Change From Baseline and Change Between Amantadine and Placebo; Allowing Assessment of Sensitivity and Specificity for Each Scale Based on Receiver Operator Characteristics (ROC).|Analyses of primary outcome measures tested sensitivity to change in dyskinesia (time effect) as well as sensitivity to differences in treatment effect (time-by-treatment interaction). These analyses were conducted using repeated-measures ANOVA (RM-ANOVA) or nonparametric analyses (Friedman’s ANOVA with follow-up Wilcoxon tests). The RM-ANOVAs tested for changes in scale scores over baseline, week 4, and week 8 visits across the entire sample (time effect), as well as differences in these changes over time between treatment groups (time-by-treatment interaction). Effect size of time to change was compared using a partial eta-square estimate of effect size. An eta-squared less than or equal to 0.01 is considered small; 0.06 is considered medium; and, 0.14 is considered large.|18 months|||unitless|||Number
813260|NCT01071538|Primary|Heart Rate|Heart Rate (Beats per minute) 60-100 beats per minute is considered normal lower heart rate represent healthier outcome|8 weeks|||beats per minute||Standard Deviation|Mean
813261|NCT01071538|Secondary|Pain Numeric Rating Scale (20 Item)|measure of average physical pain score range 0-20 Higher scores indicate worse outcome|8 weeks|||units on a scale||Standard Deviation|Mean
813262|NCT01071538|Secondary|Positive and Negative Affect Scale|"Positive Affect Score: Scores can range from 10 – 50, with higher scores representing higher levels of positive affect.
Negative Affect Score: Scores can range from 10 – 50, with lower scores representing lower levels of negative affect."|8 weeks|||units on a scale||Standard Deviation|Mean
813263|NCT01071538|Secondary|Brief Symptom Inventory -- Anxiety Subscale|measure of anxiety Lower numbers indicate better outcome Theoretical Range 0-2.4|8 weeks|||units on a scale||Standard Deviation|Mean
813264|NCT01071538|Primary|UKU Side Effect Rating Scale|measure of side effects 46 items with scores of 0,1,2,3 possible. Theoretical range 0-138 Lower scores indicate fewer side effects|8 weeks|||units on a scale||Standard Deviation|Mean
813265|NCT01071538|Primary|Blood Pressure|Blood Pressure- systolic and diastolic 140/90 or lower is considered normal and indicates a better outcome.|8 weeks|||mm Hg||Standard Deviation|Mean
813266|NCT01071538|Primary|Montgomery Asberg Depression Rating Scale|measure of depression severity theoretical scale range 0-60 Lower values represent better outcome|8 weeks|||units on a scale||Standard Deviation|Mean
813267|NCT01071798|Secondary|Number of Participants Who Received Two Cycles With Clinically Relevant Changes in HAQ-Score at Last Visit During Therapy Compared to Baseline (Categorized)|In the Subpopulation With Two Cycles, the HAQ score was categorized for 12 subgroups as Clinically relevant improvement of HAQ-Score ≥0.3, Other or no clinical relevant change of HAQ Score, or Clinically relevant worsening of HAQ Score ≥0.3. Subgroups are defined as Anti-Cyclic citrullinated peptide (CCP) and Rheumatoid factor (RF) negative (-), positive (+), or Non-specified (n.sp.) and Seropositive Non-specified (n.sp.), Seronegative, or Seropositive.|24 weeks after starting Cycle 2|Subpopulation With Two Cycles with HAQ Score||participants|||Number
813268|NCT01071798|Secondary|Number of Participants Who Received Only One Treatment Cycle With Clinically Relevant Changes in HAQ-Score at Last Visit During Therapy Compared to Baseline (Categorized)|In the Main Analysis Set participants with only one treatment cycle, the HAQ score was categorized for 12 subgroups as Clinically relevant improvement of HAQ-Score ≥0.3, Other or no clinical relevant change of HAQ Score, or Clinically relevant worsening of HAQ Score ≥0.3. Subgroups are defined as Anti-Cyclic citrullinated peptide (CCP) and Rheumatoid factor (RF) negative (-), positive (+), or Non-specified (n.sp.) and Seropositive Non-specified (n.sp.), Seronegative, or Seropositive.|24 weeks after starting Cycle 1|Main Analysis Set with HAQ Score||participants|||Number
813269|NCT01071798|Secondary|Percentage of Participants With a Treatment-Emergent Adverse Event (TEAE)||during Cycle 1, during Cycle 2, during the trial (within 12 months)|||percentage of participants|||Number
813270|NCT01071798|Primary|HAQ Disability Index (HAQ-DI)|The HAQ-DI score consists of questions referring to 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. For each of the categories, participants reported the amount of difficulty they had in performing 2 or 3 specific subcategory items. The standard disability score is calculated from the 8 categories by dividing the sum of the individual categories by the number of categories answered, yielding a score from 0 (without any difficulty) to 3 (unable to do).|at baseline of each cycle and approximately 15 days, 6 weeks (only cycle 1), 12 weeks (3 months), 18 weeks (only cycle 1), and 24 weeks (6 months) after the start of the respective cycle|||units on a scale||Standard Deviation|Mean
813271|NCT01071798|Primary|DAS28 Score|The DAS28 consists of swollen joint count (SJC) and tender joint count (TJC) measurements, the erythrocyte sedimentation rate (ESR) in millimeters per hour (mm/hr), and the Patient's Global Assessment of Disease Activity (participant-rated rheumatoid arthritis [RA] activity assessment) with transformed scores ranging 0 to 10; higher scores indicate greater affectation due to disease activity.|at baseline of each cycle and approximately 15 days, 6 weeks (only cycle 1), 12 weeks (3 months), 18 weeks (only cycle 1), and 24 weeks (6 months) after the start of the respective cycle|||units on a scale||Standard Deviation|Mean
813272|NCT01077544|Secondary|Efficacy Endpoints for Ph+ ALL Patients|Best Response in Ph+ ALL patients was defined as either Complete Remission (CR) with platelet recovery, Complete Remission (CR) with incomplete platelet recovery, Partial Remission (PR) or Stable disease. Stable disease was defined is defined as failure to qualify for either CR, PR, or progressive disease.|minimum of 12 cycles (28 days per cycle)|Full analysis set (FAS): consists of all patients who passed the screening and are enrolled into the study. Patients may or may not have taken study drug.||Participants|||Number
813273|NCT01077544|Secondary|Number of Ph+ CML Participants With Major Molecular Response (MMR)|The bcr-abl gene fusion encodes for a BCR-ABL fusion protein. Depending on the precise location of the fusion, the molecular weight of this protein can range from 185 to 210 kDa. Consequently BCR-ABL is referred to as p185 or p210 transcript. For the patients expressing the major BCR-ABL transcript p210, molecular response was defined and reported as the percent ratio of BCR-ABL transcripts/control gene transcripts converted to a reference standard according to the International Scale (IS). A major molecular response (MMR) is defined as a BCR-ABL/control gene ratio ≤ 0.1% (equal to a 3 log reduction in BCR-ABL transcripts) on the IS. In this study, the control gene was abl.|minimum of 12 cycles (28 days per cycle)|Full analysis set (FAS): consists of all patients who passed the screening and are enrolled into the study. Patients may or may not have taken study drug.||Participants|||Number
813274|NCT01077544|Secondary|Number of Ph+ CML Participants With Cytogenic Response|Cytogenetic response was initially assessed as the percentage of Ph+ metaphases in the bone marrow (BM) and performed within 21 days prior to study entry. A major cytogenetic response (0% to 35% Ph+ metaphases test positive for the Philadelphia chromosome) combines both complete cytogenetic (CCyR) and partial cytogenetic response (PCyR). CCyR implies 0% Ph+ metaphases in the BM, PCyR is > 0% to 35%, minor cytogenetic response (mCyR) is > 35% to 65%, minimal response is > 65% to 95% and no response is > 95% Ph+ metaphases in the BM.|minimum of 12 cycles (28 days per cycle)|FAS consist of all patients (pts) who passed screening & are enrolled into study. Patients may or may not have taken study drug. One (1) Ph+ CML patient in Group 2 was Ph+ at baseline & discontinued study prior to subsequent cytogenetic assessment. This pt doesn’t appear in any cytogenic response category.||Participants|||Number
813275|NCT01077544|Primary|Summary of Nilotinib Steady-state PK Parameters: Cmin|The full PK profiles of nilotinib in pediatric patients were assessed using serial sampling following a single 230 mg/m2 dose.|Cycle 1 Day 8 - Cycle 1 Day 28|Pharmacokinetic Analysis Set (PAS) consists of all patients who received the nilotinib dose on Day 1, had an evaluable Day 1 PK profile or provided at least one evaluable steady state trough concentration.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
813276|NCT01077544|Primary|Summary of Nilotinib Steady-state PK Parameters: CLF (Body Surface Area (BSA) Adjusted)|The steady-state PK profiles of nilotinib in pediatric patients were estimated using trough sampling following multiple 230 mg/m2 bid doses|Cycle 1 Day 8 - Cycle 1 day 28|Pharmacokinetic Analysis Set (PAS) consists of all patients who received the nilotinib dose on Day 1, had an evaluable Day 1 PK profile or provided at least one evaluable steady state trough concentration.||L/h/m^2)||Geometric Coefficient of Variation|Geometric Mean
813277|NCT01077544|Primary|Summary of Nilotinib Steady-state PK Parameters: AUCss|The steady-state PK profiles of nilotinib in pediatric patients were estimated using trough sampling following multiple 230 mg/m2 bid doses|Cycle 1 Day 8 - Cycle 1 Day 28|Pharmacokinetic Analysis Set (PAS) consists of all patients who received the nilotinib dose on Day 1, had an evaluable Day 1 PK profile or provided at least one evaluable steady state trough concentration.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
813278|NCT01077544|Primary|Summary of Nilotinib Non-compartmental PK Parameters: AUC0-12h|The full PK profiles of nilotinib in pediatric patients were assessed using serial sampling following a single 230 mg/m2 dose on Cycle 1 Day 1.|Cycle 1 Day 1|Pharmacokinetic Analysis Set (PAS) consists of all patients who received the nilotinib dose on Day 1, had an evaluable Day 1 PK profile or provided at least one evaluable steady state trough concentration.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
813279|NCT01077544|Primary|Summary of Nilotinib Non-compartmental PK Parameters: AUClast (Last = 24h)|The full PK profiles of nilotinib in pediatric patients were assessed using serial sampling following a single 230 mg/m2 dose on Cycle 1 Day 1.|Cycle 1 Day 1|Pharmacokinetic Analysis Set (PAS) consists of all patients who received the nilotinib dose on Day 1, had an evaluable Day 1 PK profile or provided at least one evaluable steady state trough concentration.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
813280|NCT01077544|Primary|Summary of Nilotinib Non-compartmental PK Parameters: Tmax|The full PK profiles of nilotinib in pediatric patients were assessed using serial sampling following a single 230 mg/m2 dose on Cycle 1 Day 1.|Cycle 1 Day 1|Pharmacokinetic Analysis Set (PAS) consists of all patients who received the nilotinib dose on Day 1, had an evaluable Day 1 PK profile or provided at least one evaluable steady state trough concentration.||h||Full Range|Median
813281|NCT01077544|Secondary|Number of Ph+ CML Participants With Confirmed Complete Hematologic Response (CHR)|A confirmed complete hematological response (CHR) is defined when all of the following criteria are achieved at two consecutive assessments, at least 4 weeks apart: white blood cell (WBC) count < 10 × 109/L; platelet < 450 × 109/L; basophils < 5%; no blasts and promyelocytes in peripheral blood (PB); myelocytes + metamyelocytes < 5% in PB; and no extramedullary involvement. The information used for hematological assessment was to be obtained from the laboratory and extramedullary data, all merged by patient and date.|minimum of 12 cycles (28 days per cycle)|Full analysis set (FAS): consists of all patients who passed the screening and are enrolled into the study. Patients may or may not have taken study drug.||Participants|||Number
813282|NCT01077544|Primary|Summary of Nilotinib Non-compartmental PK Parameters: Cmax|The full PK profiles of nilotinib in pediatric patients were assessed using serial sampling following a single 230 mg/m2 dose on Cycle 1 Day 1.|Cycle 1 Day 1|Pharmacokinetic Analysis Set (PAS) consists of all patients who received the nilotinib dose on Day 1, had an evaluable Day 1 PK profile or provided at least one evaluable steady state trough concentration.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
813283|NCT01077596|Secondary|Number of Participants Diagnosed With Prostate Cancer Who Were Regularly Exposed to the Indicated Antidepressant|In this outcome, prostate cancer is under investigation: Cancer case were nested within a cohort of new antidepressant users. New antidepressant users were defined as no previous antidepressant prescription in the previous 6 months. Prostate cancer cases were identified and matched with controls from the same new-user cohort. Cal year, calendar year; dx, diagnosis; IBD, Inflammatory Bowel Disease; OC, oral contraceptive; HRT/ERT, hormone replacement therapy/estrogen replacement therapy; NSAID, non-steroidal anti-inflammatory drug.|January 1, 1996 – December 31, 2006|Participants diagnosed with prostate cancer who were new antidepressant users.||participants|||Number
813284|NCT01077596|Secondary|Number of Participants Diagnosed With Breast Cancer Who Were Regularly Exposed to the Indicated Antidepressant|In this outcome, breast cancer is under investigation: Cancer case were nested within a cohort of new antidepressant users. New antidepressant users were defined as no previous antidepressant prescription in the previous 6 months. Breast cancer cases were identified and matched with controls from the same new-user cohort. Cal year, calendar year; dx, diagnosis; IBD, Inflammatory Bowel Disease; OC, oral contraceptive; HRT/ERT, hormone replacement therapy/estrogen replacement therapy; NSAID, non-steroidal anti-inflammatory drug.|January 1, 1996 – December 31, 2006|Participants diagnosed with breast cancer who were new antidepressant users.||participants|||Number
813319|NCT01077622|Secondary|Mean Laboratory Data for Lymphocytes at the Indicated Weeks as Assessed by a SERC|SERC assessed lymphocytes based on the data provided by trial sites.|Weeks 8, 16, 24, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.||GI/L||Standard Deviation|Mean
824833|NCT01178268|Secondary|Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)||30 days|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
813285|NCT01077596|Secondary|Number of Participants Diagnosed With Uterine Cancer Who Were Regularly Exposed to the Indicated Antidepressant|In this outcome, uterine cancer is under investigation: Cancer case were nested within a cohort of new antidepressant users. New antidepressant users were defined as no previous antidepressant prescription in the previous 6 months. Uterine cancer cases were identified and matched with controls from the same new-user cohort. Cal year, calendar year; dx, diagnosis; IBD, Inflammatory Bowel Disease; OC, oral contraceptive; HRT/ERT, hormone replacement therapy/estrogen replacement therapy; NSAID, non-steroidal anti-inflammatory drug.|January 1, 1996 – December 31, 2006|Participants diagnosed with uterine cancer who were new antidepressant users.||participants|||Number
813286|NCT01077596|Secondary|Number of Participants Diagnosed With Bladder Cancer Who Were Regularly Exposed to the Indicated Antidepressant|In this outcome, bladder cancer is under investigation: Cancer case were nested within a cohort of new antidepressant users. New antidepressant users were defined as no previous antidepressant prescription in the previous 6 months. Bladder cancer cases were identified and matched with controls from the same new-user cohort. Cal year, calendar year; dx, diagnosis; IBD, Inflammatory Bowel Disease; OC, oral contraceptive; HRT/ERT, hormone replacement therapy/estrogen replacement therapy; NSAID, non-steroidal anti-inflammatory drug.|January 1, 1996 – December 31, 2006|Participants diagnosed with bladder cancer who were new antidepressant users.||participants|||Number
813287|NCT01077596|Secondary|Number of Participants Diagnosed With Lung Cancer Who Were Regularly Exposed to the Indicated Antidepressant|In this outcome, lung cancer is under investigation: Cancer case were nested within a cohort of new antidepressant users. New antidepressant users were defined as no previous antidepressant prescription in the previous 6 months. Lung cancer cases were identified and matched with controls from the same new-user cohort. Cal year, calendar year; dx, diagnosis; IBD, Inflammatory Bowel Disease; OC, oral contraceptive; HRT/ERT, hormone replacement therapy/estrogen replacement therapy; NSAID, non-steroidal anti-inflammatory drug.|January 1, 1996 – December 31, 2006|Participants diagnosed with lung cancer who were new antidepressant users.||participants|||Number
813288|NCT01077596|Secondary|Number of Participants Diagnosed With Colorectal Cancer Who Were Regularly Exposed to the Indicated Antidepressant|In this outcome, colorectal cancer is under investigation: Cancer case were nested within a cohort of new antidepressant users. New antidepressant users were defined as no previous antidepressant prescription in the previous 6 months. Colorectal cancer cases were identified and matched with controls from the same new-user cohort. Cal year, calendar year; dx, diagnosis; IBD, Inflammatory Bowel Disease; OC, oral contraceptive; HRT/ERT, hormone replacement therapy/estrogen replacement therapy; NSAID, non-steroidal anti-inflammatory drug.|January 1, 1996 – December 31, 2006|Participants diagnosed with colorectal cancer who were new antidepressant users.||participants|||Number
813289|NCT01077596|Primary|Number of Participants Diagnosed With Any of the Cancers Under Investigation Who Were Regularly Exposed to the Indicated Antidepressant|The following are the cancers under investigation: colorectal, lung, bladder, uterus, breast, and prostate. Cancer case were nested within a cohort of new antidepressant users. New antidepressant users were defined as no previous antidepressant prescription in the previous 6 months. Cases were identified and matched with controls from the same new-user cohort. Cal year, calendar year; dx, diagnosis; IBD, Inflammatory Bowel Disease; OC, oral contraceptive; HRT/ERT, hormone replacement therapy/estrogen replacement therapy; NSAID, non-steroidal anti-inflammatory drug.|January 1, 1996 – December 31, 2006|Participants diagnosed with colorectal, lung, bladder, uterus, breast, or prostate cancer who were new antidepressant users||participants|||Number
813290|NCT01077622|Other Pre-specified|Serum Hemolytic Complement Titer at Weeks 36 and 48: CH50|The CH50 is the serum complement to lyse 50% of sensitized red blood cells; it's is a marker of complement activation. A high CH50 level suggests evidence for complement activation, whereas a low CH50 level suggests lack of complement activation.|Weeks 36 and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.||Kilo units per liter (KU/L)||Standard Deviation|Mean
813291|NCT01077622|Secondary|Mean Residence Time (MRTinf) of Ofatumumab|MRTinf is the average amount of time that ofatumumab spends in the body. Blood sampling on Day 1 and at Weeks 7 and 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), and 120 hr (5 days) after infusion of ofatumumab. At Weeks 7 and 24, blood sampling was also performed 168 hr (7 days) and 336 hr (14 days) after infusion of ofatumumab.|Day 1; Weeks 7 and 24|PK Parameter Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.||hr||95% Confidence Interval|Geometric Mean
813292|NCT01077622|Secondary|Volume of Distribution at Steady State (Vss) for Ofatumumab|Vss for ofatumumab was calculated as a ratio of the amount of ofatumumab in the body in equilibrium conditions to steady-state plasma concentrations. Blood sampling on Day 1 and at Weeks 7 and 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), and 120 hr (5 days) after infusion of ofatumumab. At Weeks 7 and 24, blood sampling was also performed 168 hr (7 days) and 336 hr (14 days) after infusion of ofatumumab.|Day 1; Weeks 7 and 24|PK Parameter Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.||mL||95% Confidence Interval|Geometric Mean
813293|NCT01077622|Secondary|Volume of Distribution (Vz) During the Terminal Phase for Ofatumumab|Vz for ofatumumab was calculated as a ratio of the amount of ofatumumab in the body during the terminal phase to the plasma concentration during the terminal phase. Blood sampling on Day 1 and at Weeks 7 and 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), and 120 hr (5 days) after infusion of ofatumumab. At Weeks 7 and 24, blood sampling was also performed 168 hr (7 days) and 336 hr (14 days) after infusion of ofatumumab.|Day 1; Weeks 7 and 24|PK Parameter Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.||mL||95% Confidence Interval|Geometric Mean
813305|NCT01077622|Secondary|Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Weeks 8, 24, and 48|Immunoglobulins, or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Low levels indicate immuno-suppression. IgA, IgG, and IgM were measured in the blood samples of the participants.|Baseline and Weeks 8, 24, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.||g/L||Standard Deviation|Mean
813294|NCT01077622|Secondary|Clearance (CL) of Ofatumumab From Plasma|CL of ofatumumab from plasma of participants was evaluated. Blood sampling on Day 1 and at Weeks 7 and 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), and 120 hr (5 days) after infusion of ofatumumab. At Weeks 7 and 24, blood sampling was also performed 168 hr (7 days) and 336 hr (14 days) after infusion of ofatumumab.|Day 1; Weeks 7 and 24|PK Parameter Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.||mL/hr||95% Confidence Interval|Geometric Mean
813295|NCT01077622|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC[0-infinity]) for Ofatumumab|Blood sampling on Day 1 and at Weeks 7 and 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), and 120 hr (5 days) after infusion of ofatumumab. At Weeks 7 and 24, blood sampling was also performed 168 hr (7 days) and 336 hr (14 days) after infusion of ofatumumab.|Day 1; Weeks 7 and 24|PK Parameter Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.||hr*mcg/mL||95% Confidence Interval|Geometric Mean
813296|NCT01077622|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to 672 hr (AUC[0-672]) for Ofatumumab at Week 24|Blood sampling at Week 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), 120 hr (5 days), 168 hr (7 days), and 336 hr (14 days) after infusion of ofatumumab.|Week 24|PK Parameter Population. Only participants contributing evaluable data at the indicated time points were analyzed.||hr*mcg/mL||95% Confidence Interval|Geometric Mean
813297|NCT01077622|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to 168 hr (AUC[0-168]) for Ofatumumab at Week 7|Blood sampling at Week 7 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), 120 hr (5 days), 168 hr (7 days), and 336 hr (14 days) after infusion of ofatumumab.|Week 7|PK Parameter Population||hr*mcg/mL||95% Confidence Interval|Geometric Mean
813298|NCT01077622|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC[0-t]) for Ofatumumab|AUC(0-t) was evaluated from the plasma concentration versus time curve from time zero to the last measurable time point (time t). Blood sampling on Day 1 and at Weeks 7 and 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), and 120 hr (5 days) after infusion of ofatumumab. At Weeks 7 and 24, blood sampling was also performed 168 hr (7 days) and 336 hr (14 days) after infusion of ofatumumab.|Day 1; Weeks 7 and 24|PK Parameter Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.||hr*mcg/mL||95% Confidence Interval|Geometric Mean
813299|NCT01077622|Secondary|Half-life (t1/2) of Ofatumumab|t1/2 of ofatumumab is the time required for the plasma concentration of ofatumumab to decrease by half. Blood sampling on Day 1 and at Weeks 7 and 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), and 120 hr (5 days) after infusion of ofatumumab. At Weeks 7 and 24, blood sampling was also performed 168 hr (7 days) and 336 hr (14 days) after infusion of ofatumumab.|Day 1; Weeks 7 and 24|PK Parameter Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.||hr||95% Confidence Interval|Geometric Mean
813300|NCT01077622|Secondary|Time to Reach Cmax (Tmax) Following Ofatumumab Administration|Blood sampling on Day 1 and at Weeks 7 and 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), and 120 hr (5 days) after infusion of ofatumumab. At Weeks 7 and 24, blood sampling was also performed 168 hr (7 days) and 336 hr (14 days) after infusion of ofatumumab.|Day 1; Weeks 7 and 24|PK Parameter Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.||hr||Full Range|Median
813301|NCT01077622|Secondary|Minimum Plasma Concentration (Cmin) of Ofatumumab|Blood sampling at Weeks 7 and 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), 120 hr (5 days), 168 hr (7 days), and 336 hr (14 days) after infusion of ofatumumab.|Weeks 7 and 24|PK Parameter Population||mcg/mL||95% Confidence Interval|Geometric Mean
813302|NCT01077622|Secondary|Maximum (Peak) Plasma Concentration (Cmax) of Ofatumumab|Blood sampling on Day 1 and at Weeks 7 and 24 for pharmacokinetic (PK) evaluation was performed at the following time points: 0.5 hour (hr) before infusion; end of infusion; and 10 minutes (min), 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), and 120 hr (5 days) after infusion of ofatumumab. At Weeks 7 and 24, blood sampling was also performed 168 hr (7 days) and 336 hr (14 days) after infusion of ofatumumab.|Day 1; Weeks 7 and 24|PK Parameter Population: all participants who received at least one dose of investigational drug, and in whom PK data were available and allowed parameter estimations. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.||Micrograms per milliliter (mcg/mL)||95% Confidence Interval|Geometric Mean
813303|NCT01077622|Secondary|Number of Participants With a Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)|ECOG PS is used to assess how a participant's disease is progressing, to assess how the disease affects the daily living abilities of the participant, and to determine appropriate treatment and prognosis. The grades for the scale range from 0 (fully active) to 4 (completely disabled), with increasing severity.|Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.||participants|||Number
813304|NCT01077622|Secondary|Number of Participants Who Tested Positive/Negative for Human Anti-human Antibodies (HAHA) at Screening and at Weeks 24 and 48|HAHA are indicators of immunogenicity to ofatumumab.|Screening; Weeks 24 and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.||participants|||Number
813318|NCT01077622|Secondary|Mean Laboratory Data for Lymphocytes as a Percentage in the Bone Marrow at the Indicated Weeks as Assessed by a SERC|SERC assessed lymphocytes in the bone marrow (BM) based on the data with BM smears provided by trial sites.|Weeks 8, 16, 24, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.||percentage of lymphocytes in BM||Standard Deviation|Mean
813306|NCT01077622|Secondary|Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks|Extreme fatigue is one of the clinical characteristics of CLL. B symptoms are systemic symptoms of fever, night sweats, weight loss, and extreme fatigue, which can be associated with CLL. Participants who had extreme fatigue at BL, and still had extreme fatigue at Week 1, for example, are represented in the BL, yes; Week 1, yes category. Participants who had extreme fatigue at BL, but did not have extreme fatigue at Week 1 are represented in the BL, yes; Week 1, no category.|Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.||participants|||Number
813307|NCT01077622|Secondary|Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks|Fever is one of the clinical characteristics of CLL. B symptoms are systemic symptoms of fever, night sweats, weight loss, and extreme fatigue, which can be associated with CLL. Participants who had fever at BL, and still had fever at Week 1, for example, are represented in the BL, yes; Week 1, yes category. Participants who had fever at BL, but did not have fever at Week 1 are represented in the BL, yes; Week 1, no category.|Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.||participants|||Number
813308|NCT01077622|Secondary|Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks|Weight loss is one of the clinical characteristics of CLL. B symptoms are systemic symptoms of fever, night sweats, weight loss, and extreme fatigue, which can be associated with CLL. Participants who had weight loss at BL, and still had weight loss at Week 1, for example, are represented in the BL, yes; Week 1, yes category. Participants who had weight loss at BL, but did not have weight loss at Week 1 are represented in the BL, yes; Week 1, no category.|Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.||participants|||Number
813309|NCT01077622|Secondary|Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks|Night sweats are one of the clinical characteristics of CLL. B symptoms are systemic symptoms of fever, night sweats, weight loss, and extreme fatigue, which can be associated with CLL. Participants who had night sweats at BL, and still had night sweats at Week 1, for example, are represented in the BL, yes; Week 1, yes category. Participants who had night sweats at BL, but did not have night sweats at Week 1 are represented in the BL, yes; Week 1, no category.|Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.||participants|||Number
813310|NCT01077622|Secondary|Ratio of Immunoglobulin (Ig) Kappa/Ig Lambda|Peripheral blood Ig kappa and Ig lambda were measured using flow cytometry. Abnormality of a ratio of Ig kappa and Ig lambda indicates clonality of lymphocytes. A normal range of this parameter is between 1.0 and 3.2.|Day 1; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.||Ratio of Ig kappa/Ig lambda||Standard Deviation|Mean
813311|NCT01077622|Secondary|Number of Peripheral Blood CD23+ CD5+ Cells|CD23+ CD5+ cells in the peripheral blood were counted as measures of malignant B-cells and were measured by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus.|Day 1; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.||GI/L||Standard Deviation|Mean
813312|NCT01077622|Secondary|Number of Peripheral Blood CD20+ CD5+ Cells|CD20+ CD5+ cells in the peripheral blood were counted as measures of malignant B-cells and were measured by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus.|Day 1; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.||GI/L||Standard Deviation|Mean
813313|NCT01077622|Secondary|Number of Peripheral Blood CD19+ CD5+ Cells|CD19+ CD5+ cells in the peripheral blood were counted as measures of malignant B-cells and were measured by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus.|Day 1; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.||GI/L||Standard Deviation|Mean
813314|NCT01077622|Secondary|Number of Peripheral Blood CD19+ CD23+ Cells|CD19+ CD23+ cells in the peripheral blood were counted as measures of malignant B-cells and were measured by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus.|Day 1; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.||GI/L||Standard Deviation|Mean
813315|NCT01077622|Secondary|Number of Peripheral Blood CD20+ CD23+ Cells|CD20+ CD23+ cells in the peripheral blood were counted as measures of malignant B-cells and were measured by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus.|Day 1; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.||GI/L||Standard Deviation|Mean
813316|NCT01077622|Secondary|Number of Peripheral Blood Cluster of Differentiation (CD) CD19+ CD20+ Cells|CD19+ CD20+ cells in the peripheral blood were counted as measures of malignant B-cells and were measured by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus.|Day 1; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.||GI/L||Standard Deviation|Mean
813317|NCT01077622|Secondary|Mean Laboratory Data for Total Neutrophils (Total ANC) at the Indicated Weeks as Assessed by a SERC|SERC assessed total neutrophils based on the data provided by trial sites.|Weeks 8, 16, 24, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.||GI/L||Standard Deviation|Mean
813320|NCT01077622|Secondary|Percentage of Bone Marrow Infiltration at the Indicated Weeks as Assessed by a SERC|SERC assessed bone marrow infiltration with the bone marrow smears of participants provided by trial sites.|Weeks 8, 16, 24, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.||Percentage of bone marrow infiltration||Standard Deviation|Mean
813321|NCT01077622|Secondary|Mean Laboratory Data for Platelet Count at the Indicated Weeks as Assessed by the Investigator|Blood samples of the participants were collected for the assessment of platelets.|Day 1; Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.||GI/L||Standard Deviation|Mean
813322|NCT01077622|Secondary|Mean Laboratory Data for Total Neutrophils (Total Absolute Neutrophil Count [ANC]) at the Indicated Weeks as Assessed by the Investigator|Blood samples of the participants were collected for the assessment of total neutrophils.|Day 1; Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.||GI/L||Standard Deviation|Mean
813323|NCT01077622|Secondary|Mean Laboratory Data for Lymphocytes as a Percentage in the Bone Marrow at the Indicated Weeks as Assessed by the Investigator|Bone marrow (BM) aspiration was performed, and the bone marrow smears were prepared for the assessment of lymphocytes in the BM.|Weeks 8, 16, 24, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.||Percentage of lymphocytes in the BM||Standard Deviation|Mean
813324|NCT01077622|Secondary|Mean Laboratory Data for Lymphocytes at the Indicated Weeks as Assessed by the Investigator|Blood samples of the participants were collected for the assessment of lymphocytes.|Day 1; Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.||Giga (10^9) per liter (GI/L)||Standard Deviation|Mean
813325|NCT01077622|Secondary|Mean Laboratory Data for Hemoglobin at the Indicated Weeks as Assessed by the Investigator|Blood samples of the participants were collected for the assessment of hemoglobin.|Day 1; Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.||Grams per liter (g/L)||Standard Deviation|Mean
813326|NCT01077622|Secondary|Time to Next Chronic Lymphocytic Leukemia (CLL) Therapy as Assessed by a SERC|Time to next CLL therapy is defined as the time from the first infusion of investigational drug to the first administration of the next CLL treatment. CLL therapy includes anti-cancer chemotherapy, anti-cancer radiotherapy, radio-immunotherapy, and antibody therapy.|Up to Week 48|All Subjects Population: only those participants who received CLL therapy were evaluated.||Weeks||95% Confidence Interval|Median
813327|NCT01077622|Secondary|Time to Response as Assessed by a SERC|Time to response is defined as the time from the first infusion of investigational drug to the first response (PR or better).|Up to Week 48|All Subjects Population: only those participants classified as responders for the assessment of objective response were evaluated.||Weeks||95% Confidence Interval|Median
813328|NCT01077622|Secondary|Overall Survival|Overall survival is defined as the time from the first infusion of investigational drug to death due to any cause.|Up to Week 48|All Subjects Population||Weeks||95% Confidence Interval|Median
813329|NCT01077622|Secondary|Duration of Response as Assessed by a SERC|Duration of response is defined as the time from the first documented evidence of PR or better until the first documented sign of PD or death due to any reason in participants with PR or better.|Up to Week 48|All Subjects Population: only those participants classified as responders for the assessment of objective response were evaluated.||Weeks||95% Confidence Interval|Median
813330|NCT01077622|Secondary|Progression-free Survival (PFS) as Assessed by a SERC|PFS is defined as the time from the start of treatment to the first documented sign of progressive disease (PD) or death due to any cause (whichever occurs earlier).|Up to Week 48|All Subjects Population: only those participants who progressed or died during the study were evaluated.||Weeks||95% Confidence Interval|Median
813331|NCT01077622|Primary|Percentage of Participants (Par.) With Objective Response (OR), Defined as Complete Remission (CR), CR Incomplete (CRi), Partial Remission (PR), and Nodular PR (nPR) as Assessed by a Safety and Evaluation Review Committee (SERC) and the Investigator|Par. were evaluated in accordance with the National Cancer Institute-sponsored Working Group. CR: no lymphadenopathy (Ly)/hepatomegaly/splenomegaly/constitutional symptoms; neutrophils >=1.5*10^9/liter (L), platelets >100*10^9/L, hemoglobin >11.0 grams/deciliter, lymphocytes (LC) <4.0*10^9/L, bone marrow (BM) sample must be normocellular for age, <30% LC, no lymphoid nodule. CRi: CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to chronic lymphocytic leukemia but related to drug toxicity. PR: >=50% decrease in LC, Ly, size of liver and spleen, etc. nPR: nodules in BM.|Up to Week 48|All Subjects Population||Percentage of participants|||Number
813332|NCT01077622|Primary|Number of Participants With a Dose-limiting Toxicity (DLT)|A DLT was defined as the following toxicological findings, according to the Common Terminology Criteria for Adverse Events (AE) v3.0: any treatment-related Grade (G) >=3 non-hematotoxic AE, occurrence of G3 infusion reaction (treatment-related AE) at the day of infusion in a participant who received pre-medication or appropriate management during infusion (glucocorticoid) (the severity of the AE must have remained as >= G3 until the next day); and any of following: >= G4 hematotoxic treatment-related AEs (neutropenia lasting 7 days or more, febrile neutropenia).|Up to Week 8|All Subjects Population: all participants who received at least one dose of investigational drug. The first 3 participants enrolled in the study were evaluated for DLT according to study design.||participants|||Number
813353|NCT01077830|Primary|Crude Rate of Newly Diagnosed Cancer-Follow-up Primary Cohort|Any incidence of cancer reported during follow-up that was assessed by the Expert Review Committee to be a new case of cancer. The crude new cancer rates for each arm were calculated as follows: Number of participants in the arm was multiplied by the Duration of Follow-up (days) and divided by 365 (days per year) to establish the Total Participant-years for the arm. The Number of New Cancers reported was then divided by the Total Participant-years and the resultant quotient was then multiplied by 100 to determine the Crude New Cancer Rate.|up to 21 Months after the end of the SEAS (base) study|Analysis population was Follow-up Primary Cohort defined as all participants in the follow-up study without a history of cancer before the start of the follow-up period.||per 100 participant-years||95% Confidence Interval|Number
813333|NCT01077713|Secondary|Duration of Response (DoR)|DoR was defined for participants who had achieved an objective response (CR/PR) (whichever status was recorded first) as the time period from first documentation of a response to the date of first occurrence of investigator documented disease progression or death. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Disease progression was defined as increase by at least 20% in the sum of the longest diameters of each target lesion, taking as a reference the smallest sum of the longest diameters or appearance of one or more new lesions. DoR was estimated using Kaplan Meier method.|Baseline; Day 15 of Cycles 3 and 6; Month 6 and then every 3 months until disease progression, death or consent withdrawal (up to 53 months)|ITT set.||months||95% Confidence Interval|Median
813334|NCT01077713|Secondary|Percentage of Participants With Disease Control|Disease control was defined as having CR/PR/SD as per RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.|Cycle 3 Day 15, Cycle 6 Day 15 and at Month 6|ITT set||percentage of participants||95% Confidence Interval|Number
813335|NCT01077713|Secondary|Percentage of Participants With an Objective Response|Objective response was defined as having a CR or PR according to a RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions.|Cycle 3 Day 15, Cycle 6 Day 15 and at Month 6|ITT set||percentage of participants||95% Confidence Interval|Number
813336|NCT01077713|Secondary|Percentage of Participants by Best Overall Response|Best overall response was defined as the best response recorded from the start of the treatment until disease progression/recurrence, assessed according to RECIST criteria v 1.1. Complete Response (CR): disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to less than (<) 10 millimeter (mm) in short axis; Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesion, and no new lesions; Progressive Disease (PD): at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions; Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|Baseline; Day 15 of Cycles 3 and 6; Month 6 and then every 3 months until disease progression, death or consent withdrawal (up to 53 months)|ITT set||percentage of participants||95% Confidence Interval|Number
813337|NCT01077713|Secondary|Overall Survival (OS)|OS was defined as the interval between the date of randomization and death from any cause. OS was estimated using Kaplan Meier method.|From randomization to death or end of the study (up to 53 months)|ITT set||months||95% Confidence Interval|Median
813338|NCT01077713|Secondary|Percentage of Participants Who Died||From randomization to death or end of the study (up to 53 months)|ITT set||percentage of participants|||Number
813339|NCT01077713|Secondary|Percentage of Participants Alive at 12 Months After Randomization||1 year|ITT set||percentage of participants||95% Confidence Interval|Number
813340|NCT01077713|Secondary|Progression Free Survival (PFS)|PFS was defined as the interval between the date of randomization and the first documentation of progressive disease or death from any cause. Disease progression was assessed according to RECIST criteria v 1.1. Disease progression was defined at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. PFS was estimated using Kaplan Meier method.|Baseline; Day 15 of Cycles 3 and 6; Month 6 and then every 3 months until disease progression, death, or consent withdrawal (up to 53 months)|ITT set||months||95% Confidence Interval|Median
813341|NCT01077713|Secondary|Percentage of Participants With Disease Progression or Death|Disease progression was assessed according to RECIST criteria v1.1. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.|Baseline; Day 15 of Cycles 3 and 6; Month 6 and then every 3 months until disease progression, death, or consent withdrawal (up to 53 months)|ITT set||percentage of participants|||Number
813342|NCT01077713|Primary|Percentage of Participants Alive and Without Progressive Disease at Month 6|Disease progression was assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 (v 1.1). Disease progression was defined at least a 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 millimeter (mm), progression of existing non-target lesions, or presence of new lesions.|Month 6|Intent-to-treat (ITT) set included all participants in the RND set who received at least one dose of any study medication; participants were classified according to treatment received.||percentage of participants||95% Confidence Interval|Number
813343|NCT01077739|Secondary|Geometric Mean Values of Pro-Angiogenic Cytokine Concentrations at Baseline and Prior to Progression|Pro-angiogenic cytokine concentrations of placental growth factor (PlGF), basic fibroblast growth factor (bFGF), and hepatocyte growth factor (HGF) in participant sera were measured and reported in units of picograms/milliliter (pg/mL). The geometric mean was calculated as exp10 (mean of log10 transformed concentration) and the standard deviation (SD) is SD of log10 transformed concentration.|Baseline, every 9 weeks until disease progression, at final visit or at withdrawal, for up to 24 months|ITT Population. Number (n) equals (=) number of participants assessed for the given parameter at the specified visit.||pg/mL||Standard Deviation|Geometric Mean
813344|NCT01077739|Secondary|Percentage of Participants With an Overall Response of Complete Response (CR) or Partial Response (PR)|"Percentage of participants with an overall response of CR or PR according to RECIST criteria.
CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal (short axis less than [<]10 millimeters [mm]). No new lesions. PR was defined as greater than or equal to (≥)30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions."|Baseline, every 9 weeks until disease progression, at end of treatment or withdrawal, for up to 24 months|ITT population; only participants with RECIST evaluations were included in the analysis.||percentage of participants|||Number
813345|NCT01077739|Secondary|PFS From the Start of First-Line Therapy|PFS from the start of first-line therapy was defined as the interval between the start of first-line therapy and the date at which second disease progression (after the start of beyond progression therapy) was documented. Progression of disease was evaluated using RECIST version 1.1 and abdominal/pelvic CT or MRI scanning. The same method of assessment and the same technique were to be used to evaluate each lesion throughout the entire study. If more than one method was used, data from the most accurate method according to RECIST were recorded. Median PFS was estimated using the Kaplan-Meier method.|Baseline, every 9 weeks until disease progression, at end of treatment or withdrawal, for up to 24 months|ITT population.||months||95% Confidence Interval|Median
813346|NCT01077739|Primary|Progression-Free Survival (PFS) From the Start of Treatment Beyond Progression|PFS from the start of treatment beyond progression was defined as the interval between the start of beyond-progression therapy and the date at which disease progression was documented. Progression of disease was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1 and abdominal/pelvic computerized tomography (CT) or magnetic resonance imaging (MRI) scanning as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The same method of assessment and the same technique were to be used to evaluate each lesion throughout the entire study. If more than one method was used, data from the most accurate method according to RECIST were recorded. Median PFS was estimated using the Kaplan-Meier method.|Baseline, every 9 weeks until disease progression, at end of treatment or withdrawal, for up to 24 months|ITT population||months||95% Confidence Interval|Median
813347|NCT01077804|Secondary|Incidence Rate of Herpes Zoster Infection|Herpes zoster cases were physician-diagnosed.|From 6 weeks to 168 months (14 years) post vaccination|||Rate per 1000 person years||95% Confidence Interval|Number
813348|NCT01077804|Primary|Incidence Rate of Breakthrough Varicella|"Parents/guardians of Varivax vaccinated children were interviewed every 6 months after vaccination. The number of participants with varicella (referred to as varicella with any symptoms) were reported by parents during the interview. No medical confirmation of the diagnosis was required."|From 6 weeks to 168 months (14 years) post vaccination|||Rate per 1000 person years||95% Confidence Interval|Number
813349|NCT01077804|Primary|Number of Participants With an Occurrence of Breakthrough Varicella|"Parents/guardians of Varivax vaccinated children were interviewed every 6 months after vaccination. The number of participants with varicella (referred to as varicella with any symptoms) were reported by parents during the interview. No medical confirmation of the diagnosis was required."|From 6 weeks to 168 months (14 years) post vaccination|||Participants|||Number
813350|NCT01077804|Secondary|Number of Participants With an Occurrence of Herpes Zoster Infection|Herpes zoster cases were physician-diagnosed cases.|From 6 weeks to 168 months (14 years) post vaccination|||Participants|||Number
813351|NCT01077817|Primary|Number of Cases of Esophageal Cancer Per 100,000 Woman-Years (Intent-to-Treat Analysis)|To assess the relative risk of esophageal cancer associated with osteoporosis study drugs (alendronate, etidronate, ibandronate, risedronate, and raloxifene), initiators of osteoporosis drugs and non-initiators (comparators, women sharing match criteria with the initiator) entered an inception cohort for every three-month period, beginning in the first quarter of 1996. Assignment to study drug exposure group remained fixed from the start of follow-up, analogous to an intent-to-treat analysis. The risk of esophageal cancer among initiators of study drug compared to non-initiators of study drug was estimated through calculation of a hazard ratio. For calculation of 721+ day hazard ratios, only esophageal cancer cases occurring at least 721 days from initiation of study drug were used. For calculation of 1441+ day hazard ratios, only esophageal cancer cases occurring at least 1441 days from initiation of study drug were used.|Up to approximately 7.3 years of follow-up|Inception Cohort came from the Overall Study Population beginning treatment with an osteoporosis study drug (initiators, 78,630 women) and 300,610 matched control women, who did not receive study drug (noninitiators). Participants may have been exposed to more than one study drug. Also, one comparator may have been used for multiple study drugs.||Number of cases per 100,0000 woman-years|||Number
813352|NCT01077817|Primary|Percentage of Participants With Exposure to Study Drugs (Case-Cohort Analysis)|To determine the use of study drugs (alendronate, etidronate, ibandronate, risedronate, and raloxifene) among female participants with esophageal cancer (cases) and a comparison subcohort, a case-cohort analysis was performed using women meeting criteria from the General Practice Research Database (GPRD, United Kingdom). Exposure to osteoporosis drugs administered 720 days before cancer onset was determined in cases and compared to contemporaneous assessments in a comparison subcohort matched by year of birth and membership in the GPRD on the case's onset date. Cases were confirmed and case onset dates determined by electronic algorithm (based on electronic medical record data) or by medical record review.|Exposure to study drug at least 720 days before disease onset|Case-Cohort analysis population came from the Overall Study Population and comprised 929 women with esophageal cancer (cases) and a Comparison Sample of 338,911 matched control women. Participants may have been exposed to more than one study drug. Also, one comparator may have been used for multiple study drugs.||Percentage of participants|||Number
813392|NCT01078571|Secondary|Radiological Evaluation of Rheumatoid Arthritis (RA).|Treating physicians were asked to obtain a structural damage assessment by performing x-rays of the hands and feet approximately 1 year after the previous structural damage assessment that was done prior to the participant entering the study. The number of participants with radiological erosions evaluated at baseline and the 12-month visit are summarized by subgroup.|Baseline and 12 months|This analysis was conducted in the intent-to-treat population (591 participants total).||Participant|||Number
813354|NCT01077830|Secondary|Crude Rate of Death Due to Cancer - Follow-up Primary Cohort|All deaths reported during follow-up were reviewed by the Expert Review Committee to ascertain if cancer was cause of death. The crude rates of death due to cancer for each arm were calculated as follows: Number of participants in the arm was multiplied by the Duration of Follow-up (days) and divided by 365 (days per year) to establish the Total Participant-years for the arm. The Number of Deaths due to Cancer reported was divided by the Total Participant-years and the resultant quotient was then multiplied by 100 to determine the Crude Rate of Death Due to Cancer.|up to 21 Months after the end of the base study|Analysis population was Follow-up Primary Cohort defined as all participants in the follow-up study without a history of cancer before the start of the follow-up period.||per 100 participant-years||95% Confidence Interval|Number
813355|NCT01077830|Secondary|Crude Rate of Death (Any Cause) - Follow-up Total Cohort|All deaths reported during follow-up were reviewed by the Expert Review Committee to ascertain cause of death. The crude rates of death for each arm were calculated as follows: Number of participants in the arm was multiplied by the Duration of Follow-up (days) and divided by 365 (days per year) to establish the Total Participant-years for the arm. The Number of Deaths (any cause) reported was divided by the Total Participant-years and the resultant quotient was then multiplied by 100 to determine the Rate of Death.|up to 21 Months after the end of the base study|Primary analysis population was Follow-Up Total Cohort defined as all participants enrolled in the study.||per 100 participant-years||95% Confidence Interval|Number
813356|NCT01077856|Secondary|Prevalence of HPV 6, 11, 16, and 18 Infection by Gardasil Vaccination Status|The percentage of participants with liquid-based cervical cytology samples positive for HPV 6, 11, 16, and 18 was to be analyzed by Gardasil vaccination status.|Four years to 5 years after Gardasil licensure (2011 to 2012)|The analysis population was to be women who underwent cervical screening. A joint decision was made by the study team to forgo the stratified analysis by vaccination status because there were few women who had both been vaccinated with Gardasil and undergone cervical cancer screening. Thus, the number of participants analyzed is zero.|||||
813357|NCT01077856|Secondary|Incidence of Other HPV-related Genital Diseases by Gardasil Vaccination Status|The incidence of other HPV-related genital diseases, including vulvar and vaginal cancers, by Gardasil vaccination status was to be assessed.|Four years to 5 years after Gardasil licensure (2011 to 2012)|The analysis population was to be women who underwent cervical screening. A joint decision was made by the study team to forgo the stratified analysis by vaccination status because there were few women who had both been vaccinated with Gardasil and undergone cervical cancer screening. Thus, the number of participants analyzed is zero.|||||
813358|NCT01077856|Secondary|Incidence of Cervical Cancer by Gardasil Vaccination Status|The incidence of other cervical cancers by Gardasil vaccination status was to be assessed.|Four years to 5 years after Gardasil licensure (2011 to 2012)|The analysis population was to be women who underwent cervical screening. A joint decision was made by the study team to forgo the stratified analysis by vaccination status because there were few women who had both been vaccinated with Gardasil and undergone cervical cancer screening. Thus, the number of participants analyzed is zero.|||||
813359|NCT01077856|Secondary|Incidence of Cervical Intraepithelial Neoplasia by Gardasil Vaccination Status|The incidence of CIN by Gardasil vaccination status was to be assessed.|Four years to 5 years after Gardasil licensure (2011 to 2012)|The analysis population was to be women who underwent cervical screening. A joint decision was made by the study team to forgo the stratified analysis by vaccination status because there were few women who had both been vaccinated with Gardasil and undergone cervical cancer screening. Thus, the number of participants analyzed is zero.|||||
813360|NCT01077856|Primary|Percentage of Live Born Babies With a Major Congenital Anomaly|The percentage of live born babies with major congenital anomalies (MCA) born to women vaccinated with Gardasil during pregnancy and to women in the general population was assessed. For Denmark and Sweden diagnoses of congenital anomaly within 1 year of birth are included; for Norway diagnoses at birth are included.|Up to 5 years after Gardasil licensure (2007 to 2011)|The analysis population represents the babies born to participating mothers, instead of female participants, because the number of babies represents the denominator for the percentage calculation, not female participants (i.e., mothers)||Percentage of babies with a MCA|||Number
813361|NCT01077856|Primary|Prevalence of HPV Infection for High-risk Types Other Than 16/18 for Participants >26 Years of Age|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The percentage of liquid-based cervical cytology samples positive for high-risk HPV Types other than 16 or 18, and not co-infected with Types 16 or 18, was analyzed.|Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)|The analysis population was participants >26 years of age with liquid-based cytology samples analyzed for HPV types||Percentage of participants||95% Confidence Interval|Number
813362|NCT01077856|Primary|Prevalence of HPV Infection for High-risk Types Other Than 16/18 for Participants <=26 Years of Age|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The percentage of liquid-based cervical cytology samples positive for high-risk HPV Types other than 16 or 18, and not co-infected with Types 16 or 18, was analyzed.|Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)|The analysis population was participants <=26 years of age with liquid-based cytology samples analyzed for HPV types||Percentage of participants||95% Confidence Interval|Number
813409|NCT01078584|Other Pre-specified|Percentage of Diabetic and Non-diabetic (Blood Pressure [BP]-Controlled and BP-Uncontrolled) Participants With Dose Increases After 12 Months|"The percentage of non-diabetic and diabetic participants whose systolic and diastolic blood pressures were “controlled” versus “uncontrolled” was assessed using 2008 CHEP-specified targets (non-diabetics: BP <140/90 mm Hg; diabetics: BP <130/80 mm Hg). The percentage of these controlled and uncontrolled participants who underwent or did not undergo a dose increase is presented."|12 Months|Evaluable participants (diabetic and non-diabetic ITT participants with available data at given time point).||percentage of participants|||Number
813363|NCT01077856|Primary|Prevalence of HPV 6/11/16/18 Infection in Participants >26 Years of Age|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The percentage of liquid-based cervical cytology samples positive for HPV 6, 11, 16, or 18 was analyzed.|Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)|The analysis population was participants >26 years of age with liquid-based cytology samples analyzed for HPV types||Percentage of participants||95% Confidence Interval|Number
813364|NCT01077856|Primary|Prevalence of HPV 6/11/16/18 Infection in Participants <=26 Years of Age|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The percentage of liquid-based cervical cytology samples positive for HPV 6, 11, 16, or 18 was analyzed.|Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)|The analysis population was participants <=26 years of age with liquid-based cytology samples analyzed for HPV types||Percentage of participants||95% Confidence Interval|Number
813365|NCT01077856|Primary|Incidence of HPV-related Histologically Confirmed Female Genital Diseases, Including Vulvar and Vaginal Cancer and Their High-grade Precursors|The incidence of HPV-related histologically confirmed female genital diseases, including vulvar and vaginal cancer and their high-grade precursors was to be assessed.|Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)|Analysis of this endpoint was not planned nor were the data collected. Thus, the number of participants analyzed is zero.|||||
813366|NCT01077856|Primary|Incidence of Cervical Cancer Associated With High-risk HPV Types Other Than 16/18 in Participants >26 Years of Age|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The percentage of new cases of cervical cancer associated with high-risk HPV types other than 16 and 18 was estimated based on the proportion of HPV 16/18 in all cervical cancer in a representative sample. Incidence was age-adjusted according to Nordic Standard Population.|Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)|The analysis population was participants >26 years of age with newly-diagnosed cervical cancer and lesional tissue samples analyzed for HPV types||Cases per 100,000 women|||Number
813367|NCT01077856|Primary|Incidence of Cervical Cancer Associated With High-risk HPV Types Other Than 16/18 in Participants <=26 Years of Age|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The percentage of new cases of cervical cancer associated with high-risk HPV types other than 16 and 18 was estimated based on the proportion of HPV 16/18 in all cervical cancer in a representative sample. Incidence was age-adjusted according to Nordic Standard Population.|Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)|The analysis population was participants <=26 years of age with newly-diagnosed cervical cancer and lesional tissue samples analyzed for HPV types||Cases per 100,000 women|||Number
813368|NCT01077856|Primary|Incidence of HPV 6/11/16/18-related Cervical Cancer in Participants >26 Years of Age|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The number of new cases of HPV 6/11/16/18-related cervical cancer was estimated based on the proportion of HPV 6/11/16/18 in all cervical cancers in a representative sample. Incidence was age-adjusted according to Nordic Standard Population.|Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)|The analysis population was participants >26 years of age with newly-diagnosed cervical cancer and lesional tissue samples analyzed for HPV types||Cases per 100,000 women|||Number
813369|NCT01077856|Primary|Incidence of HPV 6/11/16/18-related Cervical Cancer in Participants <=26 Years of Age|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The number of new cases of HPV 6/11/16/18-related cervical cancer was estimated based on the proportion of HPV 6/11/16/18 in all cervical cancers in a representative sample. Incidence was age-adjusted according to Nordic Standard Population.|Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)|The analysis population was participants <=26 years of age with newly-diagnosed cervical cancer and lesional tissue samples analyzed for HPV types||Cases per 100,000 women|||Number
813393|NCT01078571|Secondary|Life Quality Assessment Health Assessment Questionnaire (HAQ Questionnaire) Percentage Change From Baseline.|Quality of life was assessed using the Health Assessment Questionnaire (HAQ). The HAQ is a self-reported scale used in studies of rheumatoid arthritis to assess areas such as dressing/grooming arising, eating, walking, reach, grip, maintaining hygiene, and daily activities. The global HAQ questionnaire was scored as follows: <1 = no/mild disability, 1 to 2 = moderate disability, and >2 = severe disability. An increased score indicates a worsening of the disability. The percentage change from baseline to 12 months (12-month score minus baseline score divided by baseline score) is presented.|Baseline and 12 Months|The analysis was conducted for participants who had both baseline and 12-month global HAQ assessments.||Percentage change||Standard Deviation|Mean
813370|NCT01077856|Primary|Incidence of HPV 6/11/16/18-related Cervical Cancer in Participants of All Ages|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The number of new cases of HPV 6/11/16/18-related cervical cancer was estimated based on the proportion of HPV 6/11/16/18 in all cervical cancers in a representative sample. Incidence was age-adjusted according to Nordic Standard Population.|Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)|The analysis population was participants with newly-diagnosed cervical cancer and lesional tissue samples analyzed for HPV types||Cases per 100,000 women|||Number
813371|NCT01077856|Primary|Incidence of Cervical Intraepithelial Neoplasia Associated With High-risk HPV Types Other Than 16/18 in Participants >26 Years of Age|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The percentage of new cases of high-grade (2/3) CIN related to high-risk HPV types other than 16 and 18 was analyzed. High-risk HPV types include 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68. Incidence was age-adjusted according to Nordic Standard Population.|Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)|The analysis population was participants >26 years of age with newly-diagnosed high-grade CIN and lesional tissue samples analyzed for HPV types||Cases per 100,000 women|||Number
813372|NCT01077856|Primary|Incidence of Cervical Intraepithelial Neoplasia Associated With High-risk HPV Types Other Than 16/18 in Participants <=26 Years of Age|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The percentage of new cases of high-grade (2/3) CIN related to high-risk HPV types other than 16 and 18 was analyzed. High-risk HPV types include 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68. Incidence was age-adjusted according to Nordic Standard Population.|Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)|The analysis population was participants <=26 years of age with newly-diagnosed high-grade CIN and lesional tissue samples analyzed for HPV types||Cases per 100,000 women|||Number
813373|NCT01077856|Primary|Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia for Participants >26 Years of Age|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The number of new cases of HPV 6/11/16/18-related high-grade (2/3) CIN was estimated based on the proportion of HPV 6/11/16/18 in all CIN in a representative sample. Incidence was age-adjusted according to Nordic Standard Population.|Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)|The analysis population was participants >26 years of age with newly-diagnosed high-grade CIN and lesional tissue samples analyzed for HPV types||Cases per 100,000 women|||Number
813374|NCT01077856|Primary|Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia for Participants <=26 Years of Age|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The number of new cases of HPV 6/11/16/18-related high-grade (2/3) CIN was estimated based on the proportion of HPV 6/11/16/18 in all CIN in a representative sample. Incidence was age-adjusted according to Nordic Standard Population.|Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)|The analysis population was participants <=26 years of age with newly-diagnosed high-grade CIN and lesional tissue samples analyzed for HPV types||Cases per 100,000 women|||Number
813375|NCT01077856|Primary|Incidence of Human Papillomavirus (HPV) 6/11/16/18-related Cervical Intraepithelial Neoplasia for Participants of All Ages|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The number of new cases of HPV 6/11/16/18-related high-grade (2/3) CIN was estimated based on the proportion of HPV 6/11/16/18 in all CIN in a representative sample. Incidence was age-adjusted according to Nordic Standard Population.|Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)|The analysis population was participants of all ages with newly-diagnosed high-grade CIN and lesional tissue samples analyzed for HPV types||Cases per 100,000 women|||Number
813376|NCT01077856|Primary|Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants >26 Years of Age in Sweden|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. The collection of such data in these registries is mandated by law and compliance is generally very high. The number of new cases of high-grade (2/3) CIN registered during the assessment periods in Sweden was recorded. Incidence rates are for women >26 years of age and were age-adjusted using the European Standard Population. The incidence before Gardasil licensure is an average over the 3-year period.|Three years before Gardasil licensure (2004 to 2006 combined) and annually after Gardasil licensure (2007, 2008, 2009, 2010, and 2011)|The analysis population was the entire population of qualifying women >26 years of age in Sweden and thus changed throughout the analysis. The number of participants analyzed given below is an estimate calculated from the number of reported cases and the incidence data.||Cases per 100,000 women|cases||Number
813377|NCT01077856|Primary|Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants <=26 Years of Age in Sweden|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. The collection of such data in these registries is mandated by law and compliance is generally very high. The number of new cases of high-grade (2/3) CIN registered during the assessment periods in Sweden was recorded. Incidence rates are for women <=26 years of age and were age-adjusted using the European Standard Population. The incidence before Gardasil licensure is an average over the 3-year period.|Three years before Gardasil licensure (2004 to 2006 combined) and annually after Gardasil licensure (2007, 2008, 2009, 2010, and 2011)|The analysis population was the entire population of qualifying women <=26 years of age in Sweden and thus changed throughout the analysis. The number of participants analyzed given below is an estimate calculated from the number of reported cases and the incidence data.||Cases per 100,000 women|cases||Number
813378|NCT01077856|Primary|Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants of All Ages in Sweden|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. The collection of such data in these registries is mandated by law and compliance is generally very high. The number of new cases of high-grade (2/3) CIN registered during the assessment periods in Sweden was recorded. Incidence rates are for all age groups and were age-adjusted using the European Standard Population. The incidence before Gardasil licensure is an average over the 3-year period.|Three years before Gardasil licensure (2004 to 2006 combined) and annually after Gardasil licensure (2007, 2008, 2009, 2010, and 2011)|The analysis population was the entire population of qualifying women in Sweden and thus changed throughout the analysis. The number of participants analyzed given below is an estimate calculated from the number of reported cases and the incidence data.||Cases per 100,000 women|cases||Number
813379|NCT01077856|Primary|Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants >26 Years of Age in Norway|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. The collection of such data in these registries is mandated by law and compliance is generally very high. The number of new cases of high-grade (2/3) CIN registered during the assessment periods in Norway was recorded. Incidence rates are for women >26 years of age were age-adjusted using the European Standard Population. The incidence before Gardasil licensure is an average over the 3-year period.|Three years before Gardasil licensure (2004 to 2006 combined) and annually after Gardasil licensure (2007, 2008, 2009, 2010, and 2011)|The analysis population was the entire population of women >26 years of age in Norway and thus changed throughout the analysis. The number of participants analyzed given below is an estimate calculated from the number of reported cases and the incidence data.||Cases per 100,000 women|cases||Number
813380|NCT01077856|Primary|Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants <=26 Years of Age in Norway|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. The collection of such data in these registries is mandated by law and compliance is generally very high. The number of new cases of high-grade (2/3) CIN registered during the assessment periods in Norway was recorded. Incidence rates are for women <=26 years of age and were age-adjusted using the European Standard Population. The incidence before Gardasil licensure is an average over the 3-year period.|Three years before Gardasil licensure (2004 to 2006 combined) and annually after Gardasil licensure (2007, 2008, 2009, 2010, and 2011)|The analysis population was the entire population of qualifying women <=26 years of age in Norway and thus changed throughout the analysis. The number of participants analyzed given below is an estimate calculated from the number of reported cases and the incidence data.||Cases per 100,000 women|cases||Number
813381|NCT01077856|Primary|Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants of All Ages in Norway|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. The collection of such data in these registries is mandated by law and compliance is generally very high. The number of new cases of high-grade (2/3) CIN registered during the assessment periods in Norway was recorded. Incidence rates are for all age groups and were age-adjusted using the European Standard Population. The incidence before Gardasil licensure is an average over the 3-year period.|Three years before Gardasil licensure (2004 to 2006 combined) and annually after Gardasil licensure (2007, 2008, 2009, 2010, and 2011)|The analysis population was the entire population of qualifying women in Norway and thus changed throughout the analysis. The number of participants analyzed given below is an estimate calculated from the number of reported cases and the incidence data.||Cases per 100,000 women|cases||Number
813382|NCT01077856|Primary|Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants >26 Years of Age in Denmark|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. The collection of such data in these registries is mandated by law and compliance is generally very high. The number of new cases of high-grade (2/3) CIN registered during the assessment periods in Denmark was recorded. Incidence rates are for women >26 years of age and were age-adjusted using the European Standard Population. The incidence before Gardasil licensure is an average over the 3-year period.|Three years before Gardasil licensure (2004 to 2006 combined) and annually after Gardasil licensure (2007, 2008, 2009, 2010, and 2011)|The analysis population was the entire population of qualifying women >26 years of age in Denmark and thus changed throughout the analysis. The number of participants analyzed given below is an estimate calculated from the number of reported cases and the incidence data.||Cases per 100,000 women|cases||Number
813405|NCT01078584|Other Pre-specified|Number of Participants Discontinuing Concomitant Cardiovascular Medications at 3 Months|Presented by type of medication discontinued.|3 Months|Evaluable participants (all participants in the ITT cohort with available data at given time point).||participants|||Number
813406|NCT01078584|Other Pre-specified|Number of Participants Adding Concomitant Cardiovascular Medications at 12 Months|Presented by type of medication added.|12 Months|Evaluable participants (all participants in the ITT cohort with available data at given time point).||participants|||Number
813383|NCT01077856|Primary|Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants <=26 Years of Age in Denmark|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. The collection of such data in these registries is mandated by law and compliance is generally very high. The number of new cases of high-grade (2/3) CIN registered during the assessment periods in Denmark was recorded. Incidence rates are for women <=26 years of age and were age-adjusted using the European Standard Population. The incidence before Gardasil licensure is an average over the 3-year period.|Three years before Gardasil licensure (2004 to 2006 combined) and annually after Gardasil licensure (2007, 2008, 2009, 2010, and 2011)|The analysis population was the entire population of qualifying women <=26 years of age in Denmark and thus changed throughout the analysis. The number of participants analyzed given below is an estimate calculated from the number of reported cases and the incidence data.||Cases per 100,000 women|cases||Number
813384|NCT01077856|Primary|Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia (CIN) for Participants of All Ages in Denmark|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. The collection of such data in these registries is mandated by law and compliance is generally very high. The number of new cases of high-grade (2/3) CIN registered during the assessment periods in Denmark was recorded. Incidence rates are for all age groups and were age-adjusted using the European Standard Population. The incidence before Gardasil licensure is an average over the 3-year period.|Three years before Gardasil licensure (2004 to 2006 combined) and annually after Gardasil licensure (2007, 2008, 2009, 2010, and 2011)|The analysis population was the entire population of qualifying women in Denmark and thus changed throughout the analysis. The number of participants analyzed given below is an estimate calculated from the number of reported cases and the incidence data.||Cases per 100,000 women|cases||Number
813385|NCT01078441|Primary|One-year Survival in Patients Treated With This Regimen.|Proportion of patients who are still alive at 1 year after registration.|Assessed at 1 year|All eligible and treated patients are included in this analysis.||Proportion of patients||90% Confidence Interval|Number
813386|NCT01078454|Primary|Proportion of Patients With Hematologic Overall Response (Partial Response [PR]+ Very Good PR [VGPR]+ Amyloid Complete Response [ACR]+ Stringent Complete Response [sCR]) After 3 Months (3 Cycles) of Therapy|sCR: ACR and no clonal cells in bone marrow (BM) ACR: Negative serum/urine immunofixation (IF), <5% plasma cells in BM, and normal serum FLC ratio VGPR: 1. PR and any of the following; 2. serum/urine M-protein detectable by IF but not measurable (NM) on electrophoresis (EP); (3) ≥90% reduction in serum M-component and urine M-protein <100 mg/24 hr if baseline serum measurable; (4) urine M-component <100 mg/24 hr and NM serum M-protein on serum protein EP if baseline urine measurable; (5) ≥90% drop in the difference between involved and uninvolved FLC levels if only FLC measurable PR: (1) ≥50% drop of serum M-protein and 24-hr urinary M-protein drop by ≥90% or to <200 mg/24 hr if baseline serum/urine measurable; or (2) ≥50% drop of serum M-protein if only serum measurable at baseline; or (3) 24-hr urinary M-protein drop by ≥90% or to <200 mg/24 hr if baseline urine measurable; or (4) ≥ 50% drop in the difference between involved and uninvolved FLC if only FLC measu|Assessed at 3 months|All enrolled patients are included in this analysis.||Proportion of patients||90% Confidence Interval|Number
813387|NCT01078545|Secondary|Reported Adverse Events/Serious Adverse Events|Adverse events (AEs) were collected during the course of the study from the first visit (Baseline) through the last visit (12 months). The number of participants experiencing a non-serious or serious adverse event or both types of events are summarized. See the Reported Adverse Event section for details.|Baseline to 12 months|Analysis conducted in the intent-to-treat population.||Participants|||Number
813388|NCT01078545|Secondary|Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12.|Changes in the intensity of the following symptoms connected with prostate cancer: hematospermia (blood in the sperm), lower abdominal pain, urine incontinence, erectile dysfunction, crotch pain, anal pain or bleeding, lumbar/back pain, bone pain, spinal compression symptoms, peripheral lymph node enlargement, and lymphatic oedema of lower extremities. The intensity of each symptom was rated by the participant from 1 (minimum) to 7 (maximum). Zero indicates that the symptom was not present.|Baseline to 3, 6, 9, and 12 months.|Analysis conducted in the intent-to-treat population.||Units on a scale||Full Range|Median
813389|NCT01078545|Secondary|Percentage of Patients at Baseline With One of the Symptoms Connected With Prostate Cancer.|Percentage of participants at baseline with one of the following symptoms connected with prostate cancer: hematospermia (blood in the sperm), lower abdominal pain, urine incontinence, erectile dysfunction, crotch pain, anal pain or bleeding, lumbar/back pain, bone pain, spinal compression symptoms, peripheral lymph node enlargement, and lymphatic oedema of lower extremities. The intensity of each symptom was rated by the participant from 1 (minimum) to 7 (maximum). Zero indicates that the symptom was not present.|Baseline|Analysis conducted in the intent-to-treat population.||Percentage of participants|||Number
813390|NCT01078545|Secondary|The Change in the International Prostate Symptom Score (IPSS) From Baseline to 3, 6, 9, and 12 Months.|The International Prostate Symptom Score (IPSS) is used to assess the severity of lower urinary tract symptoms (LUTS) and to monitor disease progression. The IPSS is calculated from 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, and straining [rated as 0 (not at all) to 5 (almost always)], as well as how many times on average a participant has to get up to urinate at night (0=none to 5=5 times or more). The total score is classified as follows: 0 to 7 = mildly symptomatic; 8 to 19 = moderately symptomatic; and 20 to 35 = severely symptomatic.|Baseline to 3, 6, 9, and 12 months.|Analysis conducted in the intent-to-treat population.||units on a scale||Standard Deviation|Mean
813391|NCT01078545|Primary|The Change in the International Prostate Symptom Score (IPSS) From Baseline to Month 12. The IPSS Has a Range From 0 to 35.|The International Prostate Symptom Score (IPSS) is used to assess the severity of lower urinary tract symptoms (LUTS) and to monitor disease progression. The IPSS is calculated from 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, and straining [rated as 0 (not at all) to 5 (almost always)], as well as how many times on average a participant has to get up to urinate at night (0=none to 5=5 times or more). The total score is classified as follows: 0 to 7 = mildly symptomatic; 8 to 19 = moderately symptomatic; and 20 to 35 = severely symptomatic.|Baseline to 12 months|Analysis conducted in the intent-to-treat population.||units on a scale||Standard Deviation|Mean
813394|NCT01078571|Secondary|Life Quality Assessment Health Assessment Questionnaire (HAQ Questionnaire) Mean Change From Baseline.|Quality of life was assessed using the Health Assessment Questionnaire (HAQ). The HAQ is a self-reported scale used in studies of rheumatoid arthritis to assess areas such as dressing/grooming arising, eating, walking, reach, grip, maintaining hygiene, and daily activities. The global HAQ questionnaire was scored as follows: <1 = no/mild disability, 1 to 2 = moderate disability, and >2 = severe disability. An increased score indicates a worsening of the disability. The mean change in global HAQ score from baseline to 12 months is reported (baseline value - final value).|Baseline and 12 months|The analysis was conducted for participants who had both baseline and 12-month global HAQ assessments.||Units on a scale||Standard Deviation|Mean
813395|NCT01078571|Secondary|Clinical Evaluation of Rheumatoid Arthritis (RA). Clinical Evaluation in the Inclusion Visit and in Each One of the Study Visits.|The treating physician was to clinically assess each participant at each study visit and report the number of painful and swollen joints. The mean number of painful or swollen joints for participants evaluated at each time point are presented by subgroup. The number of participants evaluated in each subgroup at each time point are also reported.|Baseline, 1, 4, 6, and 12 months|This analysis was conducted in the ITT population of 591 participants who had assessments at each time point. The number of de novo participants and participants treated greater than 4 months who were analyzed at each time point are given in parentheses.||Joints||Standard Deviation|Mean
813396|NCT01078571|Secondary|Disease Activity Score (DAS 28) Index Percentage Change From Baseline. The Disease Activity Score (DAS) is a Combined Index That Has Been Developed to Measure the Disease Activity in Patients With Rheumatoid Arthritis (RA).|"The DAS 28 index measures disease activity in rheumatoid arthritis and is derived from the number swollen/tender joints, laboratory tests of inflammation, and participant assessment of global health (by marking a 10 cm line from very good to very bad). Ranges were used to classify participants, with a higher score indicating worse control of disease: Remission (<= 2.6), Low Disease Activity (>2.6 to <=3.2), Moderate Disease Activity (>3.2 to <= 5.1) and High Disease Activity (>5.1). The percentage reduction of baseline values is presented."|Baseline and 12 months|Mean reduction from baseline to 12 months was calculated for the ITT population of 310 de novo and 279 participants treated greater than 4 months.||Percentage reduction||Standard Deviation|Mean
813397|NCT01078571|Secondary|Disease Activity Score (DAS 28) Index Mean Change From Baseline. The Disease Activity Score (DAS) is a Combined Index That Has Been Developed to Measure the Disease Activity in Patients With Rheumatoid Arthritis (RA).|"The DAS 28 index measures disease activity in rheumatoid arthritis and is derived from the number swollen/tender joints, laboratory tests of inflammation, and participant assessment of global health (by marking a 10 cm line from very good to very bad). Ranges were used to classify participants, with a higher score indicating worse control of disease: Remission (<= 2.6), Low Disease Activity (>2.6 to <=3.2), Moderate Disease Activity (>3.2 to <= 5.1) and High Disease Activity (>5.1). The mean change in DAS 28 score from baseline to final is presented."|Baseline and 12 months|Mean change from baseline to 12 months included the ITT population of 310 de novo and 281 participants treated greater than 4 months.||Units on a scale||Standard Deviation|Mean
813398|NCT01078571|Primary|Safety and Tolerability of Adalimumab Treatment. Adverse Events: Medical Occurrence in a Patient or Clinical Investigation Subject Administered a Pharmaceutical Product and Which Does Not Necessarily Have a Causal Relationship With the Treatment|The safety and tolerability of adalimumab was assessed at each study visit. The overall number of participants experiencing serious adverse events (SAEs), non-serious adverse events (AEs) and AEs that led to discontinuation are presented. The number of participants presenting with any serious or non-serious event at each particular study visit is also reported. Note that for the incidence data participants were counted multiple times if they experienced an adverse event at more than 1 visit. For additional information see Reported Adverse Events.|Baseline, 1, 4, 6, and 12 months|This analysis was performed in the safety population of all participants who took at least 1 dose of adalimumab (675 participants).||Participants|||Number
813399|NCT01078584|Secondary|Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline Versus After 12 Months of Therapy|"Satisfaction with therapy at baseline (BL) versus 12 months, using a 5-point Likert scale where participants responded to the question “Are you satisfied with your current hypertension therapy?”. The range of responses varied from “1 = not at all satisfied” to “5 = extremely satisfied.” Responses 2 through 4 were not otherwise defined, but represented increments of more or less satisfaction with current therapy, respectively."|Day 0 (Baseline), 12 months|Subset of participants from the ITT cohort who answered the satisfaction questions at both the Baseline and 12-Month visits.||percentage of participants|||Number
813400|NCT01078584|Other Pre-specified|Percentage of Diabetic and Renal Dysfunction Participants Achieving the Target of Blood Pressure (BP) <140/90 mm Hg at 12 Months|"Participants achieving the target of blood pressure <140/90 mm Hg were considered controlled."|12 Months|Evaluable participants (ITT participants in the Diabetic or Renal Dysfunction cohorts with BP measurement at given time point).||percentage of participants|||Number
813401|NCT01078584|Other Pre-specified|Percentage of Diabetic and Renal Dysfunction Participants Achieving the Target of Blood Pressure (BP) <140/90 mm Hg at 6 Months|"Participants achieving the target of blood pressure <140/90 mm Hg were considered controlled."|6 Months|Evaluable participants (ITT participants in the Diabetic or Renal Dysfunction cohorts with blood pressure measurement at given time point).||percentage of participants|||Number
813402|NCT01078584|Other Pre-specified|Percentage of Diabetic and Renal Dysfunction Participants Achieving the Target of Blood Pressure (BP) <140/90 mm Hg at 3 Months|"Participants achieving the target of blood pressure <140/90 mm Hg were considered controlled."|3 Months|Evaluable participants (ITT participants in the Diabetic or Renal Dysfunction cohorts with BP measurement at given time point).||percentage of participants|||Number
813403|NCT01078584|Other Pre-specified|Number of Participants Discontinuing Concomitant Cardiovascular Medications at 12 Months|Presented by type of medication discontinued.|12 Months|Evaluable participants (all participants in the ITT cohort with available data at given time point).||participants|||Number
813404|NCT01078584|Other Pre-specified|Number of Participants Discontinuing Concomitant Cardiovascular Medications at 6 Months|Presented by type of medication discontinued.|6 Months|Evaluable participants (all participants in the ITT cohort with available data at given time point).||participants|||Number
829195|NCT01225055|Primary|Bone Mineral Density BMD of the Total Hip as Assessed by DXA.|The mean change in BMD of the total hip after 12 month of treatment|12 Months|||g/cm squared||95% Confidence Interval|Mean
813410|NCT01078584|Other Pre-specified|Percentage of Diabetic and Non-diabetic (Blood Pressure [BP]-Controlled and BP-Uncontrolled) Participants With Dose Increases After 6 Months|"The percentage of non-diabetic and diabetic participants whose systolic and diastolic blood pressures were “controlled” versus “uncontrolled” was assessed using 2008 CHEP-specified targets (non-diabetics: BP <140/90 mm Hg; diabetics: BP <130/80 mm Hg). The percentage of these controlled and uncontrolled participants who underwent or did not undergo a dose increase is presented."|6 Months|Evaluable participants (diabetic and non-diabetic ITT participants with available data at given time point).||percentage of participants|||Number
813411|NCT01078584|Other Pre-specified|Percentage of Diabetic and Non-diabetic (Blood Pressure [BP]-Controlled and BP-Uncontrolled) Participants With Dose Increases After 3 Months|"The percentage of non-diabetic and diabetic participants whose systolic and diastolic blood pressures were “controlled” versus “uncontrolled” was assessed using 2008 CHEP-specified targets (non-diabetics: BP <140/90 mm Hg; diabetics: BP <130/80 mm Hg). The percentage of these controlled and uncontrolled participants who underwent or did not undergo a dose increase is presented."|3 Months|Evaluable participants (diabetic and non-diabetic ITT participants with available data at given time point).||percentage of participants|||Number
813412|NCT01078584|Other Pre-specified|Number of Participants With Dose Changes at 12 Months||12 Months|Evaluable participants (all participants in the ITT cohort with data available at given time point).||participants|||Number
813413|NCT01078584|Other Pre-specified|Number of Participants With Dose Changes at 6 Months||6 Months|Evaluable participants (all participants in the ITT cohort with data available at given time point).||participants|||Number
813414|NCT01078584|Other Pre-specified|Number of Participants With Dose Changes at 3 Months||3 Months|Evaluable participants (all participants in the ITT cohort with data available at given time point).||participants|||Number
813415|NCT01078584|Other Pre-specified|Number of Participants Compliant With Therapy After 12 Months|Compliance after 12 months of treatment was derived using responses to the question “How many trandolapril doses have been missed since the subject’s last visit?” at Visit 2, Visit 3 and Visit 4, as follows: if the response was “zero” at all of the Visits 2 through 4 assessments, the participant was classified as “compliant” after 12 months of treatment; if the response was any value greater than zero at any of the Visits 2 through 4 assessments, regardless of the number of missed doses, the participant was classified as “non-compliant” after 12 months of treatment.|12 Months|Evaluable participants (participants in the ITT cohort with compliance data available at given time point).||participants|||Number
813416|NCT01078584|Other Pre-specified|Number of Participants Compliant With Therapy After 6 Months|Compliance after 6 months of treatment was derived using responses to the question “How many trandolapril (Mavik®) doses have been missed since the subject’s last visit?” at both Visit 2 and Visit 3, as follows: If the response was “zero” at both the Visit 2 and Visit 3 assessments, participant was classified as “compliant” after 6 months of treatment; If the response was any value greater than zero at either of the Visit 2 or Visit 3 assessments, regardless of the number of missed doses, participant was classified as “non-compliant” after 6 months of treatment|6 Months|Evaluable participants (participants in the ITT cohort with compliance data available at given time point).||participants|||Number
813417|NCT01078584|Other Pre-specified|Number of Participants Compliant With Therapy After 3 Months|Compliance after 3 months of treatment was derived using responses to the Visit 2 question “How many trandolapril (Mavik®) doses have been missed since the subject’s last visit?” If the response was “zero”, the participant was classified as “compliant.” If the response was any value greater than zero, regardless of the number of missed doses, the participant was classified as “non-compliant.”|3 Months|Evaluable participants (participants in the ITT cohort with compliance data available at given time point).||participants|||Number
813418|NCT01078584|Other Pre-specified|Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts at Month 12||Day 0 (Baseline), Month 12|Evaluable participants (ITT participants in the non-diabetic, diabetic, ISH, and renal dysfunction cohorts with blood pressure measurement at timepoint).||mm Hg||95% Confidence Interval|Mean
813419|NCT01078584|Other Pre-specified|Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts at Month 6||Day 0 (Baseline), Month 6|Evaluable participants (ITT participants in the non-diabetic, diabetic, ISH, and renal dysfunction cohorts with blood pressure measurement at timepoint).||mm Hg||95% Confidence Interval|Mean
813420|NCT01078584|Other Pre-specified|Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts at Month 3||Day 0 (Baseline), Month 3|Evaluable participants (ITT participants in the non-diabetic, diabetic, ISH, and renal dysfunction cohorts with blood pressure measurement at timepoint).||mm Hg||95% Confidence Interval|Mean
813421|NCT01078584|Other Pre-specified|Mean Baseline Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts||Day 0 (Baseline)|Evaluable participants (ITT participants in the non-diabetic, diabetic, ISH, and renal dysfunction cohorts with blood pressure measurement at timepoint).||mm Hg||95% Confidence Interval|Mean
813422|NCT01078584|Other Pre-specified|Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in ITT Cohort at 12 Months||Day 0 (Baseline), 12 Months|Evaluable participants (participants in the ITT cohort with blood pressure measurements at given timepoint).||mm Hg||95% Confidence Interval|Mean
813423|NCT01078584|Other Pre-specified|Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in ITT Cohort at 6 Months||Day 0 (Baseline), 6 Months|Evaluable participants (participants in the ITT cohort with blood pressure measurements at given time point).||mm Hg||95% Confidence Interval|Mean
813424|NCT01078584|Other Pre-specified|Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in ITT Cohort at 3 Months||Day 0 (Baseline), 3 Months|ITT cohort. n = all evaluable participants in the ITT cohort with blood pressure measurement at given timepoint.||mm Hg||95% Confidence Interval|Mean
813440|NCT01078584|Secondary|Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) in Blood Pressure (BP)-Controlled and BP-Uncontrolled Diabetics at 3 Months|"Diabetics were considered to be BP-controlled if BP <130/80 mm Hg. Diabetics were considered to be BP-uncontrolled if BP >/=130/80 mm Hg."|Baseline, 3 Months|Evaluable participants (diabetic ITT participants with eGFR measurement at given time point).||mL/min||95% Confidence Interval|Mean
813425|NCT01078584|Other Pre-specified|Percentage of Participants With Renal Dysfunction Achieving 2008 CHEP Targets After 12 Months of Therapy|"Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <130/80 mm Hg. Where a participant had both an SBP and DBP less than the target, the participant's BP was defined as controlled."|12 Months|Evaluable participants (ITT participants with renal dysfunction who had blood pressure measurements at given timepoint).||percentage of participants|||Number
813426|NCT01078584|Other Pre-specified|Percentage of Participants With Renal Dysfunction Achieving 2008 CHEP Targets After 6 Months of Therapy|"Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <130/80 mm Hg. Where a participant had both an SBP and DBP less than the target, the participant's BP was defined as controlled."|6 Months|Evaluable participants (ITT participants with renal dysfunction who had blood pressure measurements at given timepoint).||percentage of participants|||Number
813427|NCT01078584|Other Pre-specified|Percentage of Participants With Renal Dysfunction Achieving 2008 CHEP Targets After 3 Months of Therapy|"Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <130/80 mm Hg. Where a participant had both an SBP and DBP less than the target, the participant's BP was defined as controlled."|3 Months|Evaluable participants (ITT participants with renal dysfunction who had blood pressure measurements at given timepoint).||percentage of participants|||Number
813428|NCT01078584|Other Pre-specified|Percentage of Participants Achieving 2008 CHEP Targets After 12 Months of Therapy|Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <140/90 mm Hg. Where a participant had both an SBP and DBP less than the target, the participant's BP was defined as “controlled.”|12 Months|Evaluable participants (participants in the ITT cohort with blood pressure measurements at given time point).||percentage of participants|||Number
813429|NCT01078584|Other Pre-specified|Percentage of Participants Achieving 2008 CHEP Targets After 6 Months of Therapy|Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <140/90 mm Hg. Where a participant had both an SBP and DBP less than the target, the participant's BP was defined as “controlled.”|6 Months|Evaluable participants (participants in the ITT cohort with blood pressure measurements at given time point).||percentage of participants|||Number
813430|NCT01078584|Other Pre-specified|Percentage of Participants Achieving 2008 CHEP Targets After 3 Months of Therapy|Blood Pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <140/90 mm Hg. Where a participant had both an SBP and DBP less than the target, the participant's BP was defined as “controlled.”|3 Months|Evaluable participants (participants in the ITT cohort with blood pressure measurements at given time point).||percentage of participants|||Number
813431|NCT01078584|Secondary|Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline and After 12 Months of Therapy|"Satisfaction with therapy at baseline (BL) and 12 months, using a 5-point Likert scale where participants responded to the question Are you satisfied with your current hypertension therapy?. The range of responses varied from 1 = not at all satisfied to 5 = extremely satisfied. Responses 2 through 4 were not otherwise defined, but represented increments of more or less satisfaction with current therapy, respectively."|Day 0 (Baseline), 12 months|ITT cohort. n=evaluable participants from the ITT cohort who answered the satisfaction questions at Baseline and 12-Month visits.||percentage of participants|||Number
813432|NCT01078584|Secondary|Percentage of Participants With Isolated Systolic Hypertension (ISH) Reaching 2008 CHEP Systolic Blood Pressure (BP) Target After 12 Months of Therapy|The 2008 CHEP systolic BP (SBP) target is <140 mm Hg. Where a participant had an SBP less than the target, the participant's SBP was defined as “controlled.”|12 Months|Evaluable participants (ITT participants with ISH who had blood pressure measurements at given timepoint).||percentage of participants|||Number
813433|NCT01078584|Secondary|Percentage of Participants With Isolated Systolic Hypertension (ISH) Reaching 2008 CHEP Systolic Blood Pressure (BP) Target After 6 Months of Therapy|The 2008 CHEP systolic BP (SBP) target is <140 mm Hg. Where a participant had an SBP less than the target, the participant's SBP was defined as “controlled.”|6 Months|Evaluable participants (ITT participants with ISH who had blood pressure measurements at given timepoint).||percentage of participants|||Number
813434|NCT01078584|Secondary|Percentage of Participants With Isolated Systolic Hypertension (ISH) Reaching 2008 CHEP Systolic Blood Pressure (BP) Target After 3 Months of Therapy|The 2008 CHEP systolic BP (SBP) target is <140 mm Hg. Where a participant had an SBP less than the target, the participant's SBP was defined as “controlled.”|3 Months|Evaluable participants (ITT participants with ISH who had blood pressure measurements at given timepoint).||percentage of participants|||Number
813435|NCT01078584|Secondary|Change From Baseline in Microalbuminuria (MAU) at 12 Months||Baseline, 12 months|Evaluable Participants (all participants in the ITT cohort with MAU measurement at given time point).||mg/L||95% Confidence Interval|Mean
813436|NCT01078584|Secondary|Change From Baseline in Microalbuminuria (MAU) at 6 Months||Baseline, 6 Months|Evaluable Participants (all participants in the ITT cohort with MAU measurement at given time point).||mg/L||95% Confidence Interval|Mean
813437|NCT01078584|Secondary|Change From Baseline in Microalbuminuria (MAU) at 3 Months||Baseline, 3 Months|Evaluable participants (all participants in the ITT cohort with MAU measurement at given time point).||mg/L||95% Confidence Interval|Mean
813438|NCT01078584|Secondary|Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) in Blood Pressure (BP)-Controlled and BP-Uncontrolled Diabetics at 12 Months|"Diabetics were considered to be BP-controlled if BP <130/80 mm Hg. Diabetics were considered to be BP-uncontrolled if BP >/=130/80 mm Hg."|Baseline,12 Months|Evaluable participants (diabetic ITT participants with eGFR measurement at given time point).||mL/min||95% Confidence Interval|Mean
813439|NCT01078584|Secondary|Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) in Blood Pressure (BP)-Controlled and BP-Uncontrolled Diabetics at 6 Months|"Diabetics were considered to be BP-controlled if BP <130/80 mm Hg. Diabetics were considered to be BP-uncontrolled if BP >/=130/80 mm Hg."|Baseline, 6 Months|Evaluable participants (diabetic ITT participants with eGFR measurement at given time point).||mL/min||95% Confidence Interval|Mean
813560|NCT01079936|Primary|Participants With Grade 3 =/> Adverse Events|Number of participants experiencing adverse events above a Grade 3 according to the Common Terminology Criteria for Adverse Events (CTCAE) version 2.|Day 90 after stem cell transplant|||participants|||Number
813441|NCT01078584|Primary|Percentage of Non-Diabetic and Diabetic Participants Meeting Blood Pressure Targets at 12 Months|Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <140/90 mm Hg for non-diabetic participants, and SBP/DBP <130/80 mm Hg for diabetic participants.|12 months|Evaluable participants (diabetic and non-diabetic ITT participants with blood pressure measurement at given time point).||percentage of participants|||Number
813442|NCT01078584|Primary|Percentage of Non-Diabetic and Diabetic Participants Meeting Blood Pressure Targets at 6 Months|Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <140/90 mm Hg for non-diabetic participants, and SBP/DBP <130/80 mm Hg for diabetic participants.|6 months|Evaluable participants (diabetic and non-diabetic ITT participants with blood pressure measurement at given time point).||percentage of participants|||Number
813443|NCT01078584|Primary|Percentage of Non-Diabetic and Diabetic Participants Meeting Blood Pressure Targets at 3 Months|Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <140/90 mm Hg for non-diabetic participants, and SBP/DBP <130/80 mm Hg for diabetic participants.|3 months|Evaluable participants (diabetic and non-diabetic ITT participants with blood pressure measurement at given time point).||percentage of participants|||Number
813444|NCT01078623|Secondary|Change From Baseline in Morning Peak FEV1 at Day 14|FEV1 was measured via spirometry: 2 sets of tests prior to morning dose separated by 30 minutes, and then 1 set at 30 minutes, 1, 2, 3, 4, 6, 8, 10 and 12 hours post-morning dose|0 and 30 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post-morning dose at Day 14|Intent to treat (ITT) population: all randomized patients who took at least 1 dose of study drug and had at least 1 baseline and 1 post-baseline assessment of value of FEV1||Liters||Standard Error|Least Squares Mean
813445|NCT01078623|Secondary|Change From Baseline in Morning Pre-dose FEV1 at Day 14|FEV1 was measured via spirometry: 2 sets of tests prior to morning dose separated by 30 minutes|Day 14|Intent to treat (ITT) population: all randomized patients who took at least 1 dose of study drug and had at least 1 baseline and 1 post-baseline assessment of value of FEV1||Liters||Standard Error|Least Squares Mean
813446|NCT01078623|Primary|Change From Baseline in Normalized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve Over 12 Hours (AUC0-12h) After Morning Study Drug Administration at Day 14|FEV1 was measured via spirometry: 2 sets of tests prior to morning dose separated by 30 minutes, and then 1 set at 30 minutes, 1, 2, 3, 4, 6, 8, 10 and 12 hours post-morning dose|0 and 30 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post-morning dose at Day 14|Intent to treat (ITT) population: all randomized patients who took at least 1 dose of study drug and had at least 1 baseline and 1 post-baseline assessment of value of FEV1||Liters||Standard Error|Least Squares Mean
813447|NCT01078662|Secondary|Disease Control Rate at Week 16|Disease control rate is the proportion of patients with best response of complete or partial response or stable disease according to definitions of Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) till week 16.|Tumour assessments carried out at baseline ie 28 days before first study drug dose and then at week 8 and week 16|Full analysis set - all treated patients||Percentage of participants||95% Confidence Interval|Number
813448|NCT01078662|Secondary|Duration of Response|Duration of response is calculated from the date of first documented response (complete or partial) until date of documented progression (as defined by RECIST 1.1) or death (by any cause) in the absence of disease progression.|From onset of first occurrence of complete or partial response till documented progression or death by any cause in the absence of progression, assessed maximum up to 29 months|Full analysis set - all treated patients who had at least one complete or partial response during the assessment period.||days||Inter-Quartile Range|Median
813449|NCT01078662|Secondary|Overall Survival Rate at 12 Months|Overall survival rate at 12 months is defined as the proportion of patients who are alive 12 months after date of first dose|Survival follow-up from first dose till death of the patient or till end of study in absence of death, assessed maximum up to 29 months|Full analysis set - all treated patients. The Other cancer group was not analysed in accordance with the protocol.||Percentage of participants|||Number
813450|NCT01078662|Secondary|Overall Survival|Overall survival is defined as the duration from first dose till death. In absence of death, the time is calculated from first dose till the date subject last known to be alive.|Survival follow-up from first dose till death of the patient or till end of study in absence of death, assessed maximum up to 29 months|Full analysis set - all treated patients. The Other cancer group was not analysed in accordance with the protocol.||months||Inter-Quartile Range|Median
813451|NCT01078662|Secondary|Progression Free Survival|Progression free survival is defined as the duration from first dose till objective progression or death. In absence of progression or death, the time is calculated from first dose till last evaluable scanning visit.|Tumour assessments are carried out at baseline ie 28 days before first study drug dose and then every 8 weeks up to 6 months after starting study treatment, then every 12 weeks until objective disease progression, assessed maximum up to 29 months|Full analysis set - all treated patients. The Other cancer group was not analysed in accordance with the protocol.||months||Inter-Quartile Range|Median
813452|NCT01078662|Secondary|Objective Response Rate|Objective response rate is the proportion of patients with at least one measurable lesion at baseline, who experienced complete or partial response at least once during the assessment period, according to the definitions of Response Evaluation Criteria In Solid Tumours (RECIST version 1.1).|Tumour assessments carried out at baseline ie 28 days before first study drug dose and then every 8 weeks up to 6 months after starting study treatment, then every 12 weeks until objective disease progression, assessed maximum up to 29 months|Measurable disease analysis set - all treated patients having at least one measurable lesion at baseline||Percentage of participants||95% Confidence Interval|Number
813453|NCT01078662|Primary|Tumour Response Rate|Tumour response rate is the proportion of patients who experienced complete or partial response at least once during the assessment period, according to the definitions of Response Evaluation Criteria In Solid Tumours (RECIST version 1.1).|Tumour assessments carried out at baseline ie 28 days before first study drug dose and then every 8 weeks up to 6 months after starting study treatment, then every 12 weeks until objective disease progression, assessed maximum up to 29 months|Full analysis set - all treated patients||Percentage of participants||95% Confidence Interval|Number
813561|NCT01079936|Primary|Number of Participants With Day 30 DLT (Overall Study, Phase I/Phase II)|Dose limiting toxicity (DLT) was defined as regimen-related death, graft failure, grade 3 or 4 atrial fibrillation, grade 4 deep venous thrombosis, or pulmonary embolism before day 30 after auto-HCT.|Day 30 following transplant|||participants|||Number
813454|NCT01078675|Secondary|Overal Treatment Adherence|Overall adherence rate was calculated as the weighted mean of adherence rates of all consecutive visits after baseline, in which the adherence rate between 2 consecutive visits was a percentage of the number of rosuvastatin taken divided by duration of exposure. One patient received 1 dose of study drug but was not included in the efficacy and safety analyses due to a lack of follow-up data.|2-year study period|Safety analysis set||Percent of doses||Standard Deviation|Mean
813455|NCT01078675|Primary|Single Dose PK - AUC(0-24)|Serial plasma samples were taken at baseline (Week 0) at: 0.5 hours pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 9, 12 hours and on Day 1 at 24 hours after the single 10 mg dosing|Serial blood samples over 24 hours|Single dose PK analysis set||ng*hr/mL||Standard Deviation|Mean
813456|NCT01078675|Primary|Single Dose PK - Tmax|Serial plasma samples were taken at baseline (Week 0) at: 0.5 hours pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 9, 12 hours and on Day 1 at 24 hours after the single 10 mg dosing|Serial blood samples over 24 hours|Single dose PK analysis set||hr||Standard Deviation|Mean
813457|NCT01078675|Primary|Sexual Maturation by Tanner Staging at Month 24|Tanner stages (I-V) was used to characterize physical development in children and adolescent. The stages was based on external primary and secondary sex characteristics, such as the size of the breasts, genitalia, and development of pubic hair. Tanner stage is considered going up when the organs grow bigger.|At Baseline|Safety analysis set||Participants|||Number
813458|NCT01078675|Primary|Sexual Maturation by Tanner Staging at Month 12|Tanner stages (I-V) was used to characterize physical development in children and adolescent. The stages was based on external primary and secondary sex characteristics, such as the size of the breasts, genitalia, and development of pubic hair. Tanner stage is considered going up when the organs grow bigger.|At Baseline|Safety analysis set||Participants|||Number
813459|NCT01078675|Primary|Percent Change From Baseline in Height|One patient received 1 dose of study drug but was not included in the efficacy and safety analyses due to a lack of follow-up data.|At Month 12 and Month 24|Safety Population||Percent change||Standard Deviation|Mean
813460|NCT01078675|Secondary|Total Duration of Exposure|Total duration of exposure was calculated as [last dose date of rosuva - first dose date of rosuva + 1 day]. One patient received 1 dose of study drug but was not included in the efficacy and safety analyses due to a lack of follow-up data.|2-year study period|Safety analysis set||Days||Standard Deviation|Mean
813461|NCT01078675|Secondary|Adverse Events|Number of participants with Various Categories of AE's. One patient received 1 dose of study drug but was not included in the efficacy and safety analyses due to a lack of follow-up data.|2-year study period|Safety analysis set||Participant|||Number
813462|NCT01078675|Secondary|Change From Baseline in Max and Mean Carotid Intima and Media Wall Thickness (cIMT)|One patient received 1 dose of study drug but was not included in the efficacy and safety analyses due to a lack of follow-up data.|At Month 12 and Month 24|Intent-to-treat analysis set (LOCF) and healthy siblings||mm||Standard Deviation|Mean
813463|NCT01078675|Secondary|Percent Change From Baseline in HDL-C, TC, TG, Non-HDL-C, LDL-C/HDL-C, TC/HDL-C, Non HDL C/HDL-C, ApoB, ApoA-1, and ApoB/ApoA-1|One patient received 1 dose of study drug but was not included in the efficacy and safety analyses due to a lack of follow-up data.|At Month 3, Month 12 and Month 24|Intent-to-treat analysis set (LOCF)||Percent change||Standard Deviation|Mean
813464|NCT01078675|Primary|Single Dose PK - Cmax|Serial plasma samples were taken at baseline (Week 0) at: 0.5 hours pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 9, 12 hours and on Day 1 at 24 hours after the single 10 mg dosing|Serial blood samples over 24 hours.|Single dose PK analysis set||ng/mL||Standard Deviation|Mean
813465|NCT01078675|Primary|Sexual Maturation by Tanner Staging at Baseline|Tanner stages (I-V) was used to characterize physical development in children and adolescent. The stages was based on external primary and secondary sex characteristics, such as the size of the breasts, genitalia, and development of pubic hair. Tanner stage is considered going up when the organs grow bigger.|At Baseline|Safety analysis set||Participants|||Number
813466|NCT01078675|Primary|Percent Change From Baseline in LDL-C|Negative values represent a decrease and positive values represent an increase. In total, 198 patients were treated. One patient received 1 dose of study drug but was not included in the efficacy and safety analyses due to a lack of follow-up data.|At Month 3, Month 12 and Month 24|Intent-to-treat analysis set and Per-protocol analysis set||Percentage change||Standard Deviation|Mean
813467|NCT01078753|Secondary|Change in Number of Wet Nights Between Treatment Periods I and II|The number of wet nights was recorded by participants (or their caregivers) in a daily diary. The difference was calculated from the number of wet nights during the 14-day Treatment Period I minus the number of wet nights during the 14-day Treatment Period II.|Treatment Period I (weeks 1-2) and Treatment Period II (weeks 3-4)|The full analysis set.||wet nights||95% Confidence Interval|Least Squares Mean
813468|NCT01078753|Secondary|Change in Number of Wet Nights Between Baseline and Treatment Period I|The number of wet nights was recorded by participants (or their caregivers) in a daily diary. The difference was calculated from the number of wet nights during the 14-day Baseline Period minus the number of wet nights during the 14-day Treatment Period I.|Baseline (14-day period prior to starting study treatment) and Treatment Period I (weeks 1-2 after treatment initiation).|The Full analysis set.||wet nights||95% Confidence Interval|Least Squares Mean
813469|NCT01078753|Primary|Change in the Number of Wet Nights Between Baseline and Treatment Period II|The number of wet nights was recorded by participants (or their caregivers) in a daily diary. The difference was calculated from the number of wet nights during the 14-day Baseline Period minus the number of wet nights during the 14-day Treatment Period II.|Baseline (14-day period prior to starting study treatment) and Treatment Period II (weeks 3-4 after treatment initiation).|The Full Analysis Set (FAS) included all participants who received at least one dose of study treatment, satisfied all the major eligibility criteria and for whom efficacy data was obtained.||wet nights||95% Confidence Interval|Least Squares Mean
813470|NCT01078805|Secondary|Physician Criteria for Initiating FORTEO Therapy|Study investigators were provided a questionnaire that was populated with specific criteria they could choose from when they initiated Forteo therapy for their patients. They could have chosen more than one criteria, thus participants could have been counted multiple times. As this was actually a baseline characteristic rather than an outcome measure, data are presented in the baseline characteristic table rather than here.|Baseline|Participants are those who took at least one dose of study drug and had reasons documented to initiate Forteo therapy. This is a baseline characteristic; therefore data are presented in the section of Baseline Characteristics.||participants|||Number
813471|NCT01078805|Secondary|Percentage Change From Baseline in Bone Area at Month 24 Endpoint|Bone area is a defined region of interest of bone.|Baseline, up to month 24|Participants who received at least one dose of study drug and had non-missing start/stop date, and did not discontinue study drug more than 3 consecutive months at onetime during treatment phase. At least one post-baseline measurement within 24 month, last observation carried forward.||percent change of centimeter square||Standard Error|Mean
813472|NCT01078805|Secondary|Percentage Change From Baseline in Bone Mineral Content (BMC) at Month 24 Endpoint|BMC is an estimate of the amount of mineral (such as calcium) in the bone.|Baseline, up to month 24|Participants who received at least one dose of study drug and had non-missing start/stop date, and did not discontinue study drug more than 3 consecutive months at onetime during treatment phase. At least one post-baseline measurement within 24 month, last observation carried forward.||percentage (%) change of grams (g)||Standard Error|Mean
813473|NCT01078805|Secondary|Percentage Change From Baseline in Bone Mineral Density (BMD) at Month 24 Endpoint|A BMD test measures the amount of mineral (such as calcium) in a defined area of bone, grams per square centimeter (g/cm²).|Baseline, up to month 24|Participants who received at least one dose of study drug and had non-missing start/stop date, and did not discontinue study drug more than 3 consecutive months at onetime during treatment phase. At least one post-baseline measurement within 24 month, last observation carried forward.||percentage (%) change of BMD||Standard Error|Mean
813474|NCT01078805|Secondary|Treatment Adherence|Treatment adherence is the duration of time participants were on Forteo therapy during the 24-month treatment phase of the study.|up to 24 months|Participants who received at least one dose of study drug and had non-missing start/stop date, and did not discontinue study drug more than 3 consecutive months at onetime during treatment phase.||days||Standard Deviation|Mean
813475|NCT01078805|Secondary|Percentage Change From Baseline in Pain Score by Visual Analog Scale (VAS) at 24 Month Endpoint|Visual analog pain scale is a measurement instrument to measure the level of pain. Scores range from 0 to 100. Higher score indicates greater pain. Mean percentage change is (Pain score at baseline visit - Pain score at Month 24)/Pain score at baseline visit*100%.|Baseline, Month 24|Participants with at least a VAS score of 40 at baseline and at least one post-baseline measurement.||percentage change of pain score||Standard Error|Mean
813476|NCT01078805|Secondary|Percentage Change From Baseline in Back Pain Score by Visual Analog Scale (VAS) at 24 Month Endpoint|Visual analog pain scale is a measurement instrument to measure the level of pain. Scores range from 0 to 100. Higher score indicates greater pain. Mean percentage change is (Pain score at baseline visit - Pain score at Month 24)/Pain score at baseline visit*100%.|Baseline, Month 24|Participants with at least a VAS score of 40 at baseline and at least one post-baseline measurement.||percentage change of pain score||Standard Error|Mean
813477|NCT01078805|Secondary|Percentage of Participants With Clinical Vertebral Fractures|Clinical vertebral fracture was defined as a fracture that caused pain and/or discomfort, came to medical attention, and was confirmed by the investigator. Vertebral fracture sites included thoracic vertebra number 4 (T4) through lumbar spine vertebra number 4 (L4). Vertebral fracture is binary outcome (Yes/No). Percentage of participants= number of participants with new vertebral fracture/ number of participants at risk * 100.|up to 24 months|Participants who received at least one dose of study drug and had non-missing start/stop date, and did not discontinue study drug more than 3 consecutive months at onetime during treatment phase.||Percentage of participants|||Number
813478|NCT01078805|Primary|Percentage of Participants With Non-Vertebral Fragility Fractures|Non-vertebral fragility fracture is defined as low trauma fracture, such as a fall from standing height. It is binary outcome (Yes/No). Percentage of participants = number of participants with new Non-Vertebral Fragility Fracture/ number of participants at risk * 100.|up to 24 months|Participants who received at least one dose of study drug and had non-missing start/stop date, and did not discontinue study drug more than 3 consecutive months at onetime during treatment phase.||Percentage of participants|||Number
813479|NCT01078844|Primary|Clinical Global Impression-Scale(CGI-S)||12 weeks|This study was terminated prematurely and data was not collected for this outcome measure.|||||
813483|NCT01078922|Secondary|Overall Clinical Benefit (OCB)|"OCB = # patients with a CR + # of patients with a PR + # patients with Stable Disease (SD) divided by the number of evaluable patients CR and PR is defined in Outcome Measure #1
SD is defined as:
Failure to attain CR/PR or Progressive Disease (PD)
PET remains positive.
PD is defined as:
Any new lesion > 1.5 cm in longest axis
An increase 50% or more of previously involved sites from nadir
50% increase in SPD of more than one node or 50% increase in the longest diameter of a previously identified node that is > 1 cm in shortest axis
PET remains positive if it was positive before therapy."|Evaluated every 2 cycles (every 2 months), up to 80 weeks|||percentage of participants|||Number
813484|NCT01078922|Primary|Overall Response (OR)|"OR = # of patients with a Complete Response (CR) plus # of patients with a Partial Response (PR) divided by the total # of evaluable patients.
A CR is defined as:
Disappearance of all disease.
If nodal masses that Positron Emission Tomography (PET)- positive prior to therapy; they must be PET negative
If the nodal masses were Variably or PET negative; they must regress to normal.
No palpable liver or spleen
Palpable nodal masses are no longer palpable
Negative bone marrow biopsy
A PR is defined as:
Regression of measurable disease and no new sites of disease.
> 50% decrease in Sum of Product of Diameters (SPD) of up to 6 largest masses with no increase in the size of other nodes. If the nodal masses were PET positive prior to therapy then PET positive at previously involved sites is allowed. If they were Variably or PET negative then regression on CT is required.
No increase in the size of the liver or spleen"|evaluated every 2 months up to 80 weeks|Analysis was per protocol. Patients were evaluated every 2 cycles for Overall Response, up to 80 weeks.||percentage of participants|||Number
813485|NCT01078974|Primary|Tolerability of Pomalidomide|Number of participants with dose limiting toxicities which resulted in being removed from pomalidomide therapy|2 years|||participants|||Number
813486|NCT01078974|Primary|Maximum Tolerated Dose of Pomalidomide|To determine the MTD of pomalidomide administered orally in patients with Waldenstrom's Macroglobulinemia in combination with dexamethasone and rituximab. Because maximum tolerated dose was not determined due to study termination, the highest dose of pomalidomide administered is presented below.|2 years|The maximum tolerated dose was not determined due to study termination. Three participants experienced IgM flare causing them to be removed from the study early.||mg|||Number
813487|NCT01079130|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) After 1 Day of Treatment|Spirometry was conducted according to internationally accepted standards. The trough FEV1 was defined as the average of the FEV1 measurements taken at 23 hours 10 minutes and 23 hours 45 minutes post dose on day 2. The mixed model used baseline FEV1 and FEV1 prior to and 30 minutes post inhalation of albuterol as covariates.|Day 2 (after 1 day of treatment)|Participants from the Full Analysis Set, randomized participants who received at least one dose of study drug, who had efficacy data for this outcome measure.||Liters||Standard Error|Least Squares Mean
813488|NCT01079130|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) After 2 Weeks of Treatment|Spirometry was conducted according to internationally accepted standards. The trough FEV1 was defined as the average of the FEV1 measurements taken at 23 hours 10 minutes and 23 hours 45 minutes post dose. The mixed model used baseline FEV1 and FEV1 prior to and 30 minutes post inhalation of albuterol as covariates.|Day 15 (after 2 weeks of treatment)|Participants from the Full Analysis Set, randomized participants who received at least one dose of study drug, who had efficacy data for this outcome measure. Missing data were imputed last observation carried forward (LOCF).||Liters||Standard Error|Least Squares Mean
813489|NCT01079143|Secondary|Incidence (Number) of Participants With Graft Losses|If a participant underwent a graft nephrectomy, then the day of nephrectomy was considered as the day of graft loss.|M6 and M12 post transplantation|ITT population: All patients randomized in the study who received at least one dose of the study treatment.||Participants|||Number
813490|NCT01079143|Secondary|Incidence (Number) of BPAR|A biopsy proven acute rejection (BPAR) is defined as a biopsy graded IA, IB, IIA, IIB or III as per 2005/2007 Banff histological classification system.|M6 and M12 post transplantation|ITT population: All patients randomized in the study who received at least one dose of the study treatment.||Number of participants|||Number
813491|NCT01079143|Secondary|Severity of BPAR|"A biopsy proven acute rejection (BPAR) is defined as a biopsy graded IA, IB, IIA, IIB or III as per 2005/2007 Banff histological classification system.
Biopsy graded IA: Significant interstitial infiltration (> 25% of parenchyma) and foci of moderate tubulitis (> 4 mononuclear cells/tubular cross section or group of 10 tubular cells).
Biopsy grade IB: Significant interstitial infiltration (> 25% of parenchyma) and foci of severe tubulitis (> 10 mononuclear cells/tubular cross section or group of 10 tubular cells).
Biopsy grade IIA: Mild to moderate intimal arteritis. Biopsy graded IIB: Severe intimal arteritis comprising > 25% of the lumenal area.
Biopsy graded III: Transmural (full vessel wall thickness) arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells (with accompanying lymphocytic inflammation)."|M6 and M12 post transplantation|ITT population: All patients randomized in the study who received at least one dose of the study treatment.||Participants|||Number
813492|NCT01079143|Secondary|Type of Biopsy Proven Acute Rejection (BPAR)|"A biopsy proven acute rejection (BPAR) is defined as a biopsy graded IA, IB, IIA, IIB or III as per 2005/2007 Banff histological classification system.
Biopsy graded IA: Significant interstitial infiltration (> 25% of parenchyma) and foci of moderate tubulitis (> 4 mononuclear cells/tubular cross section or group of 10 tubular cells).
Biopsy grade IB: Significant interstitial infiltration (> 25% of parenchyma) and foci of severe tubulitis (> 10 mononuclear cells/tubular cross section or group of 10 tubular cells).
Biopsy grade IIA: Mild to moderate intimal arteritis. Biopsy graded IIB: Severe intimal arteritis comprising > 25% of the lumenal area.
Biopsy graded III: Transmural (full vessel wall thickness) arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells (with accompanying lymphocytic inflammation)."|M6 and M12 post transplantation|ITT population: All patients randomized in the study who received at least one dose of the study treatment.||Participants|||Number
813493|NCT01079143|Secondary|Treatment Failures|A treatment failure is defined as biopsy proven acute rejection (BPAR), a graft loss, a death or a loss to follow up. It was assessed between randomization and 6 and 12 months post-transplantation.|M6 and M12 post transplantation|ITT population: All patients randomized in the study who received at least one dose of the study treatment.||Number of Participants|||Number
813494|NCT01079143|Secondary|Change in Urine Protein/Creatinine Ratio (Without Imputation)|One of the factors associated with EMT progression between M3 and M12 according to univariate analysis (ITT biopsies M3 & M12).|Month 3 (baseline), Month 12|ITT population: All patients randomized in the study who received at least one dose of the study treatment.||mg/mmol||Standard Deviation|Mean
813495|NCT01079143|Secondary|Change in Estimated Glomerular Filtration Rate (eGFR) at M12 From Baseline (M3) - ANCOVA Model|The average patient renal function was evaluated on the basis of eGFR was calculated according to the abbreviated MDRD formula and creatinine clearance according to the Cockcroft-Gault formula (mL/min/1.73m²).|Baseline (M3), M12|ITT population: All patients randomized in the study who received at least one dose of the study treatment.||mL/min/1.73m²||Standard Deviation|Mean
813496|NCT01079143|Secondary|Change From Baseline (M3) in Estimated Glomerular Filtration Rate (eGFR)|"eGFR was calculated according to the abbreviated Modification of Diet in Renal Disease (MDRD) Formula and creatinine clearance according to the Cockcroft-Gault formula (mL/min/1.73m²).
LOCF = Last observation carried forward"|M3 (baseline) to M12 post transplantation|ITT population: All patients randomized in the study who received at least one dose of the study treatment.||mL/min/1.73m^2||Standard Error|Least Squares Mean
813497|NCT01079143|Secondary|Incidence (Number) of Subclinical Rejections and Borderline Lesions|"Incidence of subclinical rejections and borderline lesions with regards to histological evidence of rejection with clinical findings.
Subclinical rejections: rejection without clinical symptoms which is diagnosed by chance when a graft biopsy is performed.
Clinically suspected BPAR: rejection suspected because of the presence of clinical symptoms (fever, pain, increase of creatinine) and then confirmed by the graft biopsy.
Borderline lesions: suspicious for acute T-cell mediated rejection. This category is used when no intimal arteritis is present, but there are foci of tubulitis with minor interstitial infiltration or interstitial infiltration with mild tubulitis."|M3|ITT population: All patients randomized in the study who received at least one dose of the study treatment.||Participants|||Number
813498|NCT01079143|Secondary|Change in EMT Score|"Change (M12 - M3) in EMT Score. Progression in EMT score is defined as an increase by >=1 of EMT score from M3 to M12.
EMT score 0 (the best): <1 EMT score 1 (the better) : 1-10% of tubular atrophy EMT score 2 : 10-25% of tubular atrophy EMT score 3 : 25-50% of tubular atrophy EMT score 4 (the worst): >50% of tubular atrophy"|M3 and M12 post transplantation|ITT population: All patients randomized in the study who received at least one dose of the study treatment. Among the 194 participants in the ITT group, 58 patients in the EMT+ group completed the study providing a graft biopsy for analysis at M3 and M12.||scores on a scale||Standard Deviation|Mean
813499|NCT01079143|Secondary|Number of Participants With Epithelial-mesenchymal Transition (EMT) Score|"Incidence and severity of EMT score. The intensity of EMT markers expression present and detectable in the renal graft at an early stage following transplantation is known as EMT score.
EMT score 0 (the best): <1 EMT score 1 (the better): 1-10% of tubular atrophy EMT score 2: 10-25% of tubular atrophy EMT score 3: 25-50% of tubular atrophy EMT score 4 (the worst): >50% of tubular atrophy"|M3 and M12 post transplantation|ITT population: All patients randomized in the study who received at least one dose of the study treatment. Among the 194 participants in the ITT group, 58 patients in the EMT+ group completed the study providing a graft biopsy for analysis at M3 and M12.||participants|||Number
813500|NCT01079143|Secondary|Number of Participants With Epithelial-mesenchymal Transition (EMT) Status|Incidence and severity of EMT status. EMT status was determined centrally using the graft biopsy taken at 3 months. The result was quickly obtained (within 7 to 15 days) and sent to the company in charge of randomization in order to allocate each patient to a treatment group and to provide the investigator with this information without confirming EMT status.|M3 and M12 post transplantation|ITT population: All patients randomized in the study who received at least one dose of the study treatment. Among the 194 participants in the ITT group, 58 patients in the EMT+ group completed the study providing a graft biopsy for analysis at M3 and M12.||Participants|||Number
813501|NCT01079143|Secondary|Number of Participants With Progression of Renal Fibrosis Using Numerical Quantification|Comparisons according to epithelial-mesenchymal transition (EMT) profile and immunosuppressive treatment|M3 to M12 post transplantation|ITT population: All patients randomized in the study who received at least one dose of the study treatment. Among the 194 participants in the ITT group, 58 patients in the EMT+ group completed the study providing a graft biopsy for analysis at M3 and M12.||Participants|||Number
813502|NCT01079143|Secondary|Change in Percentage of Interstitial Fibrosis (IF) by Numerical Quantification|Percentage of IF measured by numerical quantification. The IF percentage was transposed in grade according to the following rule: grade 0 for an IF % ≤5%, grade I for an IF % ranging from >5% to < 25%, grade II for an IF % ranging from 25 to 50%, grade III for an IF % >50%. Interstitial graft fibrosis has been identified as the primary cause of graft loss following death with a functional graft [3-5].|M3 and M12 post transplantation|ITT population: All patients randomized in the study who received at least one dose of the study treatment. Among the 194 participants in the ITT group, 58 patients in the EMT+ group completed the study providing a graft biopsy for analysis at M3 and M12.||Percentage of IF||Standard Deviation|Mean
813503|NCT01079143|Secondary|Risk Factors of IF/TA Progression|"Composite factors regarding fibrosis progression at 12 months using a logistic regression model; the parameters initially considered concerned the demographic characteristics of both recipient and donor, transplantation characteristics, hypertension, diabetes, study treatments, immunosuppression, EMT, IF/TA, function at M3, the onset of acute rejection, the presence of anti-donor antibodies at M12, infections and BK virus viremia.
Arteriolar hyaline thickening is thickening of the walls of arterioles by the deposition of homogeneous pink hyaline material.
BPAR is biopsy proven acute rejection. TEM progression is the increase ≥ 1 of TEM score between Month 3 and Month 12"|M12 post transplantation|ITT population: All patients randomized in the study who received at least one dose of the study treatment. Among the 194 participants in the ITT group, 58 patients in the EMT+ group completed the study providing a graft biopsy for analysis at M3 and M12.||Participants|||Number
813504|NCT01079143|Secondary|Change in Interstitial Fibrosis/Tabular Atrophy (IF/TA) Grade|Difference (M12 - M3) in IF/TA grade. IF/TA grade was assessed during centralized reading according to the Banff 2005/2007 classification comprising grade I (<25%), grade II (25-50%) and grade III (>50% of lesions).|M3 and M12 post transplantation|ITT population: All patients randomized in the study who received at least one dose of the study treatment. Among the 194 participants in the ITT group, 58 patients in the EMT+ group completed the study providing a graft biopsy for analysis at M3 and M12.||Number of Participants|||Number
813505|NCT01079143|Secondary|Interstitial Fibrosis/Tabular Atrophy (IF/TA)|Incidence and severity of IF/TA according to 2005/2007 Banff classification system grades (grades l to lll). IF/TA grade was assessed during centralized reading according to the Banff 2005/2007 classification comprising grade I (<25%), grade II (25-50%) and grade III (>50% of lesions).|M3 and M12 post transplantation|ITT population: All patients randomized in the study who received at least one dose of the study treatment. Among the 194 participants in the ITT group, 58 patients in the EMT+ group completed the study providing a graft biopsy for analysis at M3 and M12.||Number of participants|||Number
813506|NCT01079143|Primary|Number of Participants With Progression of Renal Graft Fibrosis (Primary Comparison - ITT Population|"Progression of Interstitial Fibrosis/Tabular Atrophy (IF/TA) is the percentage (%) of participants with an increase >= 1 in IF/TA grade according to Banff (2005 - 2007)according to Epithelial-mesenchymal transition (EMT) profile and by treatment groups.
Grade I (the better): mild interstitial fibrosis and tubular atrophy (<25% of cortical area) Grade II : moderate interstitial fibrosis and tubular atrophy (26-50% of cortical area) Grade III (the worse) : severe interstitial fibrosis and tubular atrophy (>50% of cortical area)"|Month 3 (M3) and Month 12 (M12) post transplantation|ITT population: All patients randomized in the study who received at least one dose of the study treatment. Among the 194 participants in the ITT group, 58 patients in the EMT+ group completed the study providing a graft biopsy for analysis at M3 and M12. The primary comparison concerned only the Certican and the Neoral EMT+ groups.||Participants|||Number
813507|NCT01079182|Secondary|Mean Equivalent Dose of Prednisolone|The mean equivalent dose of prednisolone was calculated based on the International Standard for comparison of different glucocorticoid products.|At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.||mg/day||Standard Deviation|Mean
814963|NCT01092663|Primary|Fasting Gluconeogenesis|Change from baseline in fasting gluconeogenesis after 12 weeks of colesevelam alone or colesevelam plus sitagliptin treatment|baseline and 12 weeks|||umol per kilogram (kg) FFM per min||Standard Deviation|Mean
813508|NCT01079182|Secondary|Percentage of Participants With Concomitant Pain Relief/Anti-Inflammatory Agents|Participants with concomitant pain relief/anti-inflammatory agents like analgesics, non-steroidal anti-inflammatory drugs (NSAIDs), cyclooxygenase-2 (COX-2) inhibitors, and systemic glucocorticoids were assessed during the study period.|At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.||Percentage of participants|||Number
813509|NCT01079182|Secondary|Percentage of Participants With Concomitant Non-Biologic Disease-modifying Antirheumatic Drugs (DMARDs)||At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.||Percentage of participants|||Number
813510|NCT01079182|Secondary|Percentage of Participants on Adalimumab Monotherapy||At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.||Percentage of participants|||Number
813511|NCT01079182|Secondary|Mean Days of In-Patient Hospitalization Due to Ankylosing Spondylitis in the Previous 12 Months||At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.||Days||Standard Deviation|Mean
813512|NCT01079182|Secondary|Percentage of Participants With In-Patient Hospitalization Due to Ankylosing Spondylitis in the Previous 12 Months||At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.||Percentage of participants|||Number
813513|NCT01079182|Secondary|Mean Missed Work Days Due to Ankylosing Spondylitis in the Previous 12 Months||At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.||Days||Standard Deviation|Mean
813514|NCT01079182|Secondary|Percentage of Participants Who Missed Work Days Due to Ankylosing Spondylitis (AS) in the Previous 12 Months||At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.||Percentage of participants|||Number
813515|NCT01079182|Secondary|Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks|The impairment of daily activities was based on participant recall of events that occurred over the 4 weeks before the visit. Percentage of participants with impairment for 0, less than 7, 7 to 14, and greater than 14 days was assessed.|At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.||Percentage of participants|||Number
813516|NCT01079182|Secondary|Percentage of Participants Achieving ASAS Partial Remission Criteria|This is a four domain (participant global assessment of disease activity, assessment of spinal pain, assessment of function (BASFI), and assessment of duration/severity of morning stiffness (mean of BASDAI questions 5 and 6)), participant-reported assessment scored on a scale from 0 (best) to 10 (worst). To qualify for a partial remission, participants had to have values of 2 or less (on a scale of 10) in each of the 4 domains.|At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.||Percentage of participants|||Number
813517|NCT01079182|Primary|Number of Participants With Drug-Related Adverse Events (AEs)|An adverse event/adverse experience was any reaction, side effect or other untoward event associated with the use of a drug in humans, whether or not the event was considered drug related. This included adverse events occurring from accidental or deliberate drug overdose, from drug abuse, or from drug withdrawal. Exacerbations of pre-existing conditions are also considered adverse events. Data presented are adverse events that are drug-related and are detailed in the adverse event section of this report.|From signing of informed consent up to 24 months|Safety analysis set: Participants who received at least one dose of adalimumab.||Participants|||Number
813518|NCT01079182|Secondary|Percentage of Participants Achieving Assessment of SpondyloArthritis International Society (ASAS) Improvement Criteria|This is a four domain (participant global assessment of disease activity, assessment of spinal pain, assessment of function (BASFI), and assessment of duration/severity of morning stiffness (mean of BASDAI questions 5 and 6)), participant-reported assessment scored on a scale from 0 (best) to 10 (worst). To qualify for a 20% improvement, participants were required to have an improvement of greater than or equal to 20% and greater than or equal to 1 unit in at least 3 domains, and no worsening of greater than or equal to 20% and greater than or equal to 1 unit in the remaining domain. To achieve a 40% improvement, participants were required to have an improvement of greater than or equal to 40% and greater than or equal to 2 units in at least 3 domains, and no worsening at all in the remaining domain.|At 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.||Percentage of participants|||Number
813519|NCT01079182|Secondary|Mean Duration of Morning Stiffness|Participants accessed the duration of morning stiffness in 15 minute intervals from 0 to 2 hours. Data are reported as the mean duration of morning stiffness ± standard deviation.|At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.||minutes||Standard Deviation|Mean
813520|NCT01079182|Secondary|Percentage of Participants With Morning Stiffness|Morning stiffness was a participant-reported assessment. The number of participants with morning stiffness were assessed at each visit.|At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.||Percentage of participants|||Number
813521|NCT01079182|Secondary|Mean Participant Pain Score|Using the BASDAI questionnaire, participants assessed the overall level of AS neck, back or hip pain experienced by him/her. It was scored on a numerical rating scale from 0 (no symptoms) to 10 (severe symptoms).|At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.||Score on scale||Standard Deviation|Mean
813522|NCT01079182|Secondary|Mean Participant Fatigue Score|Using the BASDAI questionnaire, participants assessed the overall level of fatigue/tiredness experienced by him/her. It was scored on a numerical rating scale from 0 (no symptoms) to 10 (severe symptoms).|At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.||Score on scale||Standard Deviation|Mean
813674|NCT01080794|Primary|Hamilton Depression Scale (HAM-D)|"To evaluate the depressive mood symptoms in PD.
The HAM-D mean scores were reported for each group at each time point. The HAM-D Score Range is 0 - 56, where higher the score indicates greater severity of depressive mood symptoms."|Pre-treatment; Post-treatment 0,1,3, and 6 months.|||units on a scale||Standard Deviation|Mean
813523|NCT01079182|Secondary|Mean Global Assessment of Disease Activity Score|Global Assessment of Disease Activity was a participant-reported measure that evaluated disease activity. It was scored on a scale that ranged from 0 to 10; lower scores indicated better patient status.|At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.||Score on scale||Standard Deviation|Mean
813524|NCT01079182|Secondary|Mean Bath Ankylosing Spondylitis-Global (BAS-G) Score|The BAS-G was a participant-reported instrument with two items. In the first item, the participant rated the effect of their disease over the last week, and in the second item, the participant rated the effect of their disease over the previous 6 months. Each item of the BAS-G was scored on a scale ranging from 0 (no effect) to 10 (very severe effect). The mean of the two scores was the total BAS-G score and the MCID was 1.5.|At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.||BAS-G score||Standard Deviation|Mean
813525|NCT01079182|Secondary|Mean Plasma Concentrations of C-Reactive Protein (CRP)|Plasma concentrations of CRP were assessed as a marker of systemic inflammation that provided insights into the overall anti-inflammatory effect of rheumatologic therapies.|At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.||mg/L||Standard Deviation|Mean
813526|NCT01079182|Secondary|Mean Erythrocyte Sedimentation Rate (ESR)|Plasma concentrations of ESR were assessed as a marker of systemic inflammation that provided insights into the overall anti-inflammatory effect of rheumatologic therapies.|At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.||mm/hour||Standard Deviation|Mean
813527|NCT01079182|Primary|Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score|The BASFI was a ten question, participant-reported measure that evaluated physical function. Each question was scored on a numerical rating scale that ranged from 0 (no functional impairment) to 10 (maximal impairment), and the MCID was 0.7. The mean of the ten questions was the total BASFI score. Data are reported as the mean change of total score from baseline (Month 0).|At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.||BASFI score||Standard Deviation|Mean
813528|NCT01079182|Primary|Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score|The BASDAI was a six question, participant-reported measure of overall disease activity that probed the level of fatigue, neck/back/hip pain, peripheral joint swelling and pain, localized tenderness, as well as morning stiffness severity and duration. It was scored on a numerical rating scale that ranged from 0 (no symptoms) to 10 (severe symptoms), and the minimum clinically important difference (MCID) was 1.0. The final BASDAI score was calculated using the following equation, in which 01 - 06 represents the question number: (BASDAI01 + BASDAI02 + BASDAI03 + BASDAI04 + BASDAI05/2 + BASDAI06*1.25/2)/5. The scale for question 6 was reduced to 0-8 since BASDAI06 was multiplied by 1.25. Data are reported as the mean change total score from baseline (Month 0).|At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.||BASDAI score||Standard Deviation|Mean
813529|NCT01079182|Secondary|Percentage of Participants With Extraspinal Manifestations|Extraspinal manifestations (enthesitis, dactylitis, uveitis, psoriasis, and Inflammatory Bowel Disease (IBD)) were assessed by investigators and reported on the basis of their clinical evaluation and participant records.|At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.||Percentage of participants|||Number
813530|NCT01079182|Secondary|Mean Number of Involved Peripheral Joints|Peripheral joints were assessed by Tender Joint Counts (TJC) and Swollen Joint Counts (SJC), using pressure and joint manipulation during physical examination. Seventy-eight TJC and 76 SJC were evaluated and a score of 0 (not tender or swollen) or 1 (tender or swollen) was assigned for each joint with a higher total score indicating a greater number of involved joints.|At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.||Joints||Standard Deviation|Mean
813531|NCT01079195|Secondary|Evaluation of Adverse Events (AEs) Leading to Discontinuation of Tarka and a Summary of All AEs Possibly or Probably Related to Tarka by Frequency and Severity|The number of AEs leading to Tarka discontinuation are summarized. AEs that were considered by the investigator to be possibly or probably related to Tarka are summarized by the severity of the AE (classified as mild, moderate, or severe). AEs considered possibly or probably related to Tarka that led to the discontinuation of Tarka are also presented by severity.|6 months|This analysis used the safety analysis population, which included any participant who took at least one dose of Tarka and had at least one follow-up visit.||Events|||Number
813532|NCT01079195|Secondary|Percentage of Participants Achieving Target Blood Pressure (Less Than 140/90) at Study End and the Need for Other Antihypertensive Drugs, Clustered by Type(s) of Drugs Added to Tarka.|The percentages of participants achieving and not achieving the target blood pressure of less than 140/90 mmHg at the end of the study are presented. Percentages of participants taking Tarka only or taking Tarka plus another antihypertensive drug are summarized by type of drug: beta blockers, angiotensin-converting enzyme (ACE) inhibitors, calcium antagonists, diuretics, and angiotensin II (AT-II) receptor antagonists. Participants taking drugs that did not fit any of the above groups (Other), unknown drugs (Unknown), or more than one additional antihypertensive agent are also summarized.|6 months|2122 participants were excluded from the analysis for the following reasons: age less than 18 years (1), no diagnosis of hypertension (18), not at risk for diabetes (1650), no follow-up blood pressure values (48), no baseline blood pressure values (360), and started Tarka at/after first follow-up visit (45).||Percentage of participants|||Number
813533|NCT01079195|Primary|Reduction in Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to Study End|"Participants were to be followed for 6 months. Changes in systolic and diastolic blood pressure were assessed by comparing the blood pressure measurements obtained at the end of Tarka treatment (approximately 6 months) to baseline values. For this analysis of effectiveness the last available value was considered the analysis time point end of study."|Baseline to 6 months/study end|2122 participants were excluded from this analysis for the following reasons: age less than 18 years (1), no diagnosis of hypertension (18), not at risk for diabetes (1650), no follow-up blood pressure values (48), no baseline blood pressure values (360), and started Tarka at/after first follow-up visit (45).||mmHg||Standard Deviation|Mean
813534|NCT01079234|Primary|Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.|Week 0 to Week 52 + 7 days follow up|Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.The subjects randomised to 2 IDeg arms during the main trial were pooled into the IDeg OD F in extension trial.||Episodes/100 years of patient exposure|||Number
813535|NCT01079234|Primary|Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 52 + 7 days follow up|Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator. The subjects randomised to 2 IDeg arms during the main trial were pooled into the IDeg OD F in extension trial.||Episodes/100 years of patient exposure|||Number
813536|NCT01079234|Secondary|Extension Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment|Change from baseline in FPG after 52 weeks of treatment.|Week 0, Week 52|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). FPG baseline values were missing for 6 subjects. The subjects randomised to 2 IDeg arms during the main trial were pooled into the IDeg OD F in extension trial.||mmol/L||Standard Deviation|Mean
813537|NCT01079234|Secondary|Main Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 26 Weeks of Treatment|Change from baseline in FPG after 26 weeks of treatment|Week 0, Week 26|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). For 6 subjects baseline values were missing.||mmol/L||Standard Deviation|Mean
813538|NCT01079234|Secondary|Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment|Change from baseline in HbA1c after 52 weeks of treatment.|Week 0, Week 52|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). The subjects randomised to 2 IDeg arms during the main trial were pooled into the IDeg OD F in extension trial.||percentage of glycosylated haemoglobin||Standard Deviation|Mean
813539|NCT01079234|Primary|Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment|Change from baseline in HbA1c after 26 weeks of treatment|Week 0, Week 26|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF).||percentage of glycosylated haemoglobin||Standard Deviation|Mean
813540|NCT01079299|Primary|Median Time to Wound Closure at 9 Months|Median number of days for complete healing in each treatment group|9 months|||median number of days for complete heali||Standard Error|Median
813541|NCT01079390|Primary|Cortical Thickness Changes at 5-7 Weeks Post-Treatment|All eligible patients were scanned using fMRI while receiving treatment during acupuncture sessions 1, 3, and 6. Structural MRI data were only compared between Session 1 (pre-treatment) and Session 6 (post-treatment). The structural data was analyzed using FreeSurfer software.|2 days; one at baseline and another post-treatment measurement taken 5-7 weeks after baseline|We combined low and high dose acupuncture into one group because we found there were not clinical differences between the two group.||millimeters||Standard Deviation|Mean
813542|NCT01079390|Primary|Knee Injury and Osteoarthritis Outcome Score (KOOS Pain Rating) at 5-7 Weeks Post-Treatment|The Knee injury and Osteoarthritis Outcome Score (KOOS) was used to measure clinical outcomes. KOOS is measured on a scale from 0-4 with 0 being no pain and 4 being extreme pain (the worst). The KOOS is comprised of 5 subscales, each of which produces an outcome score. These subscales include pain, other symptoms, function in daily living (ADL), function in sport and recreation, and knee-related quality of life (QOL). Based on previous studies, subscale scores of the KOOS related to pain, function in daily living, and function in sport and recreation were selected as the primary outcome of the present study. For each subscale, a normalized score was calculated, where 0 indicated the most extreme symptoms/pain and 100 indicated no symptoms/pain.|One post-treatment measurement 5-7 weeks after baseline|||units on KOOS scale||Standard Deviation|Mean
813543|NCT01079598|Secondary|Cessation of Flow Reflux Through the Perforator Vein|Cessation of incompetent flow and reflux is defined as the absence of blood flow within the treated segment of the perforator vessel at the level the vessel crosses the superficial fascia. Key measures that will be used to evaluate the intervention that are a focus of the study.|6 months|Analysis was not able to be completed due to very low enrollment and limited data available. No results available.|||||
813544|NCT01079598|Secondary|CEAP Classification (Clinical Severity, Etiology or Cause, Anatomy, Pathophysiology)|CEAP Classification at Month 6 will be reported.|6 months|Analysis was not able to be completed due to very low enrollment and limited data available. No results available.|||||
813545|NCT01079598|Secondary|Cessation of Flow Through the Perforator Vein|Cessation of incompetent flow and reflux is defined as the absence of blood flow within the treated segment of the perforator vessel at the level the vessel crosses the superficial fascia. Key measures that will be used to evaluate the intervention that are a focus of the study.|6 months|Analysis was not able to be completed due to very low enrollment and limited data available. No results available.|||||
813546|NCT01079598|Primary|Quality of Life and Clinical Assessments Compared to Pretreatment Baseline.|QOL and clinical assessments measured by periodic CIVIQ2 and VCSS assessments were planned to be compared at each follow-up visit to pretreatment baseline. However, with the very low enrollment and limited data available, analysis and study results are inconclusive.|6 months|Analysis was not able to be completed due to very low enrollment and limited data available. No results available.|||||
813675|NCT01080794|Primary|Motor Subscale of the Unified Parkinson's Disease Rating Scale (UPDRS Part III)|"To evaluate the motor symptoms in Parkinson's Disease.
The UPDRS-III mean scores were reported for each group at each time point. The UPDRS-III Score Range is 0 - 56, where higher the score indicates greater severity of the motor symptoms."|Pre-treatment; Post-treatment 0,1,3, and 6 months.|||units on a scale||Standard Deviation|Mean
813555|NCT01079832|Secondary|Clinical Response Rate|Percentage of patients with a clinical response following RECIST (Response Evaluation Criteria in Solid Tumors) Criteria: Confirmed complete response(CR), Stable disease (SD), partial response (PR), or without progressive disease (PD).|at 6 months from study entry|Intent to treat||percentage of participants||95% Confidence Interval|Number
813556|NCT01079832|Secondary|Quality of Life||After completion of study treatment, patients are followed at 1, 3, 6, 12, 18 and 24 months.|Participant surveys were unreliably returned to investigators, making this analysis not meaningful.|||||
813557|NCT01079832|Secondary|Median Overall Survival|Length of time patients survived at study end.|24 months|Intent to treat||months||95% Confidence Interval|Median
813558|NCT01079832|Secondary|Disease-free Survival|Median disease free survival|completion of study at 24 months|Intent to treat||months||95% Confidence Interval|Median
813559|NCT01079832|Primary|Acute Toxicity Rate|The incidence of grade 3 or 4 possible SBRT-related non-hematological toxicities observed during a 6 month period.|at 6 months after treatment|Intent to treat||percentage of participants|||Number
829231|NCT01225354|Secondary|Aesthetic Improvement|Subject and Investigator will complete GAIS at Visits 2-4 comparing overall appearance of current visit’s photo to baseline photo|Visit 2-4||||||
813562|NCT01079936|Primary|Number of Participants With Response (CR at Day 90)|Response is defined as the event that the participant is alive with complete response (CR) at day 90 (+/-30 days). CR defined as: A) Absence of monoclonal protein in urine and serum when analyzed by immunofixation electrophoresis. B) The bone marrow should be normal by morphological examination with <5% plasma cells. There should be < 1% aneuploid light chain restricted population by flow cytometry for DNA/cIg. C) While healing of bone lesions not required, no new lytic lesion should appear. Further compression fracture of spine will be not considered as progressive disease.|Day 90 after stem cell transplant|||participants|||Number
813563|NCT01079936|Primary|Maximum Tolerated Dose (MTD) of Lenalidomide|There were 4 doses of lenalidomide in the dose escalation phase: 25 mg, 50 mg, 75 mg, and 100 mg. The first 12 patients were treated at these dose levels (3 patients per level) and safety assessed at each level. The MTD dose level was to be the level at which participants at each lenalidomide dose level had no dose limiting toxicity (DLT). DLT defined as as regimen-related death, graft failure, grade 3 or 4 atrial fibrillation, grade 4 deep venous thrombosis, or pulmonary embolism before day 30 after auto-HCT. Each participant received a fixed dose of Melphalan plus one of the four doses 25, 50, 75 or 100 mg of Lenalidomide orally for each of 7 days, -8 to -2 pre transplant.|Assessed at 21-28 Day Cycle|Of the 16 participants in Phase I, two participants were not eligible for study due to first remission status, and two were eligible but did not receive stem cell transplant due to other issues.||mg/day|||Number
813564|NCT01079949|Secondary|Follicular Levels of Testosterone (T) at Ovum Pick up (OPU)||OPU day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 9 days}])|"ITT population included all randomized participants who had received at least 1 dose of the study medication. N (number of participants analyzed) signifies those participants who were evaluable for this measure."||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
813565|NCT01079949|Secondary|Follicular Levels of Estradiol (E2) at Ovum Pick up (OPU)||OPU day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 9 days}])|"ITT population included all randomized participants who had received at least 1 dose of the study medication. N (number of participants analyzed) signifies those participants who were evaluable for this measure."||pg/mL||Standard Deviation|Mean
813566|NCT01079949|Secondary|Follicular Levels of Luteinizing Hormone (LH), Follicle Stimulating Hormone (FSH) and Human Chorionic Gonadotropin (hCG) at Ovum Pick up (OPU)||OPU day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 9 days}])|"ITT population included all randomized participants who had received at least 1 dose of the study medication. N (number of participants analyzed) signifies those participants who were evaluable for this measure."||milli international unit (mIU)/mL||Standard Deviation|Mean
813567|NCT01079949|Secondary|Estradiol (E2) Levels on r-hCG Day||r-hCG day (end of stimulation cycle [approximately 9 days])|"ITT population included all randomized participants who had received at least 1 dose of the study medication.N (number of participants analyzed) signifies those participants with plasma E2 levels at r-hCG day."||picogram/milliter (pg/mL)||Standard Deviation|Mean
813568|NCT01079949|Secondary|Total Dose of Recombinant Human Follicle Stimulating Hormone (r-hFSH)||Day 1 of stimulation period (S1) up to r-hCG day (end of stimulation cycle [approximately 9 days])|ITT population included all randomized participants who had received at least 1 dose of the study medication.||IU||Standard Deviation|Mean
813569|NCT01079949|Secondary|Number of Ovarian Stimulation Days|Ovarian stimulation included from first r-hFSH injection (S1) until day on which r-hCG was administered (r-hCG day).|Day 1 of stimulation period (S1) up to r-hCG day (end of stimulation cycle [approximately 9 days])|ITT population included all randomized participants who had received at least 1 dose of the study medication.||days||Standard Deviation|Mean
813570|NCT01079949|Secondary|Number of Participants in Whom Recombinant Human Chorionic Gonadotropin (r-hCG) Was Not Administered Due to Poor Response|Poor response was defined as 3 or less follicles of greater than or equal to 12 mm developing following at least 7 days of study treatment.|r-hCG day (end of stimulation cycle [approximately 9 days])|ITT population included all randomized participants who had received at least 1 dose of the study medication.||participants|||Number
813571|NCT01079949|Secondary|Number of Participants With Clinical Pregnancies|Clinical pregnancy was defined as pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It includes ectopic pregnancy.|Day 35-42 post r-hCG day (end of stimulation cycle [approximately 9 days])|ITT population included all randomized participants who had received at least 1 dose of the study medication.||participants|||Number
813572|NCT01079949|Secondary|Implantation Rate|Implantation rate was measured as the number of gestational sacs observed, divided by the number of embryos transferred multiplied by 100.|Day 35-42 post OPU (34-38 hours post r-hCG day {end of stimulation cycle [approximately 9 days]})|"ITT population included all randomized participants who had received at least 1 dose of the study medication. N (number of participants analyzed) signifies those participants who were evaluable for this measure."||percent sacs per embryo||Standard Deviation|Mean
813573|NCT01079949|Secondary|Number and Quality of Embryos|Embryos were classified into 5 different grades (1 to 5) based on their capacity of implantation. Grade 1 embryos were those with best capacity of implantation and Grade 5 embryos were those with worst capacity of implantation.|Day 2-3 post OPU (34-38 hours post r-hCG day [end of stimulation cycle {approximately 9 days}])|"ITT population included all randomized participants who had received at least 1 dose of the study medication. N (number of participants analyzed) signifies those participants who continued with follicular development."||embryos|||Number
813574|NCT01079949|Secondary|Number of Fertilized Oocytes at Stage 2 Pronuclei (2PN) or Higher Than 2PN|Oocytes were fertilized using ICSI technique which is an in-vitro fertilization procedure in which a single sperm is injected directly into an egg under a microscope. The appearance of 2PN is the first sign of successful fertilization as observed during in vitro fertilization, and is usually observed after ICSI. The zygote is then termed 2PN. Fertilized oocytes at stage higher then 2PN are those oocytes which consist more than 2 pronuclei like oocyte having 3 pronuclei termed as 3PN, oocyte having 4 pronuclei termed as 4PN.|Day 35-42 post r-hCG day (end of stimulation cycle [approximately 9 days])|"ITT population included all randomized participants who had received at least 1 dose of the study medication. N (number of participants analyzed) signifies those participants who underwent ovum pick up."||oocytes|||Number
814280|NCT01084551|Secondary|Incidence of RLS Symptoms|Incidence rate of RLS symptoms is calculated as the number of days with RLS symptoms in the week / the number of evaluation days in the week* 100%|Baseline, the end of dose-titration/dose-maintenance period (week 13)|FAS, LOCF||percentage of days with RLS symptom||Standard Deviation|Mean
813575|NCT01079949|Secondary|Number of Fertilized Oocytes (2 Pronuclei [PN])|Oocytes were fertilized using Intra-cytoplasmic Sperm Injection (ICSI) technique which is an in-vitro fertilization procedure in which a single sperm is injected directly into an egg under a microscope. The appearance of 2PN is the first sign of successful fertilization as observed during in vitro fertilization, and is usually observed after ICSI. The zygote is then termed 2PN.|OPU day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 9 days}])|"ITT population included all randomized participants who had received at least 1 dose of the study medication. N (number of participants analyzed) signifies those participants who underwent ovum pick up."||2PN oocytes|||Number
813576|NCT01079949|Secondary|Endometrial Thickness on Recombinant Human Choriogonadotropin (r-hCG) Day|Endometrial thickness measurement was performed on the day of r-hCG administration.|r-hCG day (end of stimulation cycle [approximately 9 days])|"ITT population included all randomized participants who had received at least 1 dose of the study medication. N (number of participants analyzed) signifies those participants who were evaluable for this measure."||mm||Standard Deviation|Mean
813577|NCT01079949|Secondary|Number of Follicles Greater Than or Equal to 14 Millimeter (mm) on Recombinant Human Choriogonadotropin (r-hCG) Day||r-hCG day (end of stimulation cycle [approximately 9 days])|ITT population included all randomized participants who had received at least 1 dose of the study medication.||follicles||Standard Deviation|Mean
813578|NCT01079949|Primary|Number of Participants With Adverse Events (AEs)|An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.|S1 to 1 month ± 1 week post r-hCG day (end of stimulation cycle [approximately 9 days])|Safety population included all participants who had received at least 1 dose of the study medication.||participants|||Number
813579|NCT01079949|Primary|Number of Cycles Cancelled Due to Risk of Ovarian Hyper Stimulation Syndrome (OHSS)|Ovarian Hyper Stimulation Syndrome (OHSS) is a syndrome which can manifest with enlarged ovaries, advanced ascites with increased vascular permeability, pleural fluid accumulation, hemoconcentration, and increased blood clotting.|S1 to 1 month ± 1 week post r-hCG day (end of stimulation cycle [approximately 9 days])|Safety population included all participants who had received at least 1 dose of the study medication.||cycles|||Number
813580|NCT01079949|Primary|Number of Participants With Ovarian Hyper Stimulation Syndrome (OHSS)|Ovarian Hyper Stimulation Syndrome (OHSS) is a syndrome which can manifest with enlarged ovaries, advanced ascites with increased vascular permeability, pleural fluid accumulation, hemoconcentration, and increased blood clotting.|S1 to 1 month ± 1 week post r-hCG day (end of stimulation cycle [approximately 9 days])|Safety population included all participants who had received at least 1 dose of the study medication.||participants|||Number
813581|NCT01079949|Primary|Number of Mature Oocytes Retrieved|Number of mature oocytes retrieved per reporting group on the day of OPU (34-38 hours post r-hCG day) was calculated. Oocyte retrieval is a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body. The nuclear maturity is assessed based on the presence of a germinal vesicle (GV) or whether oocytes were in metaphase I (Meta-I) or II (Meta-II) stage or atretic.|OPU day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 9 days}])|"ITT population included all randomized participants who had received at least 1 dose of the study medication. N (number of participants analyzed) signifies those participants who underwent ovum pick up."||mature oocytes|||Number
813582|NCT01079949|Primary|Number of Oocytes Retrieved|Number of oocytes retrieved per reporting group on the day of ovum pick-up (OPU) (34-38 hours post r-hCG day) was calculated. Oocyte retrieval is a technique used in in-vitro fertilization (IVF) in order to remove oocytes from the ovary of the female participant, enabling fertilization outside the body.|Ovum pick-up (OPU) day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 9 days}])|"Intention to treat (ITT) population included all randomized participants who had received at least 1 dose of the study medication. N (number of participants analyzed) signifies those participants who underwent ovum pick up."||oocytes||Standard Deviation|Mean
813583|NCT01079962|Primary|Change From Baseline in Aortic Pulse Pressure (APP) in Per Protocol (PP) Population at Week 12|The APP was calculated as aortic systolic pressure minus aortic diastolic pressure. The change in APP at Week 12 was calculated as APP at Week 12 minus APP at baseline.|Baseline and Week 12|Per protocol (PP) population included those participants for whom primary and secondary efficacy endpoints were all measured, and who did not meet the withdrawal criteria and showed 75 percent of medication compliance.||mmHg||Standard Deviation|Mean
813584|NCT01079962|Secondary|Number of Participants With Adverse Events (AEs)|An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.|Baseline up to Week 14 (follow-up visit)|ITT population included all participants who had received at least 1 dose of the study medication or comparator and at least 1 post-dose measurement of aortic pulse pressure.||Participants|||Number
813585|NCT01079962|Secondary|Change From Baseline in Brachial Blood Pressure (BP) at Week 4 and Week 12|The change in brachial BP (brachial SBP, brachial DBP and brachial mean BP) at Week 4 and Week 12 was calculated as brachial BP (brachial SBP, brachial DBP and brachial mean BP) at Week 4 and Week 12 minus brachial BP (brachial SBP, brachial DBP and brachial mean BP) at baseline.|Baseline, Week 4 and Week 12|"ITT population included all participants who had received at least 1 dose of the study medication or comparator and at least 1 post-dose measurement of aortic pulse pressure. n signifies those participants who were evaluated for this measure at the specified time point."||mmHg||Standard Deviation|Mean
813586|NCT01079962|Secondary|Change From Baseline in Blood Glucose Levels at Week 12|The change in blood glucose level at Week 12 was calculated as blood glucose level at Week 12 minus blood glucose level at baseline.|Baseline and Week 12|ITT population included all participants who had received at least 1 dose of the study medication or comparator and at least 1 post-dose measurement of aortic pulse pressure.||Millimoles per liter (mmol/L)||Standard Deviation|Mean
813803|NCT01081873|Secondary|Epidemiological Data: Mean Weight|The mean weight of all participants at baseline is provided.|at time 0 (Baseline)|Analysis was performed on the full analysis set consisting of all patients for whom at least baseline data were recorded. Data for age was available for 2,691 patients and for weight for 2,116 patients.||kg||Standard Deviation|Mean
813587|NCT01079962|Secondary|Change From Baseline in Lipid Levels at Week 12|The lipid levels evaluated were total cholesterol, low density lipoprotein (LDL) cholesterol, and high density lipoprotein (HDL) cholesterol blood concentrations. The change in lipid levels at Week 12 was calculated as lipid levels at Week 12 minus lipid levels at baseline.|Baseline and Week 12|ITT population included all participants who had received at least 1 dose of the study medication or comparator and at least 1 post-dose measurement of aortic pulse pressure.||Milligram/decilitre (mg/dL)||Standard Deviation|Mean
813588|NCT01079962|Secondary|Change From Baseline in Aortic Pulse Pressure (APP) at Week 4|The APP was calculated as aortic systolic pressure minus aortic diastolic pressure. The change in APP at Week 4 was calculated as APP at Week 4 minus APP at baseline.|Baseline and Week 4|ITT population included all participants who had received at least 1 dose of the study medication or comparator and at least 1 post-dose measurement of aortic pulse pressure.||mmHg||Standard Deviation|Mean
813589|NCT01079962|Secondary|Change From Baseline in Heart Rate at Week 4 and Week 12|The change in heart rate at Week 4 and Week 12 was calculated as heart rate at Week 4 and Week 12 minus heart rate at baseline.|Baseline, Week 4 and Week 12|"ITT population included all participants who had received at least 1 dose of the study medication or comparator and at least 1 post-dose measurement of aortic pulse pressure. n signifies those participants who were evaluated for this measure at the specified time point."||Beats per minute (bpm)||Standard Deviation|Mean
813590|NCT01079962|Secondary|Change From Baseline in Carotid-femoral Pulse Wave Velocity (cfPWV) at Week 4 and Week 12|Pulse wave velocity (PWV) is used as a measure of arterial stiffness, which is a measure of the cushioning functioning of major vessels like the aorta. The velocity of the Pulse wave (PW) along an artery is dependent on the stiffness of that artery. The change in cfPWV at Week 4 and Week 12 was calculated as cfPWV at Week 4 and Week 12 minus cfPWV at baseline.|Baseline, Week 4 and Week 12|"ITT population included all participants who had received at least 1 dose of the study medication or comparator and at least 1 post-dose measurement of aortic pulse pressure. n signifies those participants who were evaluated for this measure at the specified time point."||Meters per second (m/s)||Standard Deviation|Mean
813591|NCT01079962|Secondary|Change From Baseline in Aortic Augmentation Index (AIx) at Week 4 and Week 12|Augmentation index is a composite measure of wave reflection and systemic arterial stiffness which was calculated as the difference between the second and first systolic peaks. The change in AIx at Week 4 and Week 12 was calculated as AIx at Week 4 and Week 12 minus AIx at baseline.|Baseline, Week 4 and Week 12|"ITT population included all participants who had received at least 1 dose of the study medication or comparator and at least 1 post-dose measurement of aortic pulse pressure. n signifies those participants who were evaluated for this measure at the specified time point."||Ratio||Standard Deviation|Mean
813592|NCT01079962|Secondary|Change From Baseline in Aortic Blood Pressure (BP) at Week 4 and Week 12|The change in aortic BP (aortic systolic blood pressure [SBP], aortic diastolic blood pressure [DBP] and aortic mean blood pressure [BP]) at Week 4 and Week 12 was calculated as aortic BP (aortic SBP, aortic DBP and aortic mean BP) at Week 4 and Week 12 minus aortic BP (aortic SBP, aortic DBP and aortic mean BP) at baseline.|Baseline, Week 4 and Week 12|"ITT population included all participants who had received at least 1 dose of the study medication or comparator and at least 1 post-dose measurement of aortic pulse pressure. n signifies those participants who were evaluated for this measure at the specified time point."||mmHg||Standard Deviation|Mean
813593|NCT01079962|Primary|Change From Baseline in Aortic Pulse Pressure (APP) in Intention to Treat (ITT) Population at Week 12|The APP was calculated as aortic systolic pressure minus aortic diastolic pressure. The change in APP at Week 12 was calculated as APP at Week 12 minus APP at baseline.|Baseline and Week 12|"ITT population included all participants who had received at least 1 dose of the study medication or comparator and at least 1 post-dose measurement of aortic pulse pressure. n signifies those participants who were evaluated for this measure at the specified time point."||Millimeter of mercury (mmHg)||Standard Deviation|Mean
813594|NCT01079988|Secondary|Patient's Global Psoriasis Assessment (PGPA)|"The PGPA consisted of a single self-explanatory item:
On a scale from 0 to 10, with 0 being no psoriasis and 10 the worst psoriasis that you can imagine, please rate the state of your psoriasis right now.
Note: Consider only your skin condition and do not consider other aspects that may be related to your psoriasis (such as psoriatic arthritis)."|12 weeks|One patient withdrew||PGPA score||Standard Deviation|Mean
813595|NCT01079988|Primary|Physician's Global Assessment (PGA) of Change Over Time (Good or Better)|"The PGA response was classified according to the following categories by changes in all clinical signs and symptoms as compared to baseline:
Cleared: Remission except for residual manifestations such as mild erythema (100% improvement) Excellent: Improvement of 75%-99% except for residual manifestations such as mild erythema Good: Improvement of 50%-74%"|12 weeks|||participants|||Number
813596|NCT01080118|Secondary|Time to Intubation|Time to intubation is the time interval of blade insertion until the removal of the laryngoscope.|120 seconds|The sample analysis was all of the medical students or interns who consented to participate in this study. All participants data was used for the analysis.||seconds||95% Confidence Interval|Mean
813597|NCT01080118|Primary|Successful Endotracheal Intubation|A successful placement of the endotracheal tube as defined by the presence of bilateral breath sounds and positive recording of end tidal carbon dioxide.|120 seconds|The sample analysis was all of the medical students or interns who consented to participate in this study. All participants data was used for the analysis.||% successful|||Number
813598|NCT01080131|Secondary|Serum Amyloid A Protein (SAA) Levels for Participants Re-treated With or Switched to Canakinumab|"Serum Amyloid A Protein (SAA) levels in blood serum were measured by a central laboratory in order to identify the presence of inflammation, to determine its severity, and to monitor the response to treatment.
Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2."|24 hours, 72 hours, 7 days, 4, 8 and 12 weeks post-dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.|Modified Analysis Set (MAS) consisting of all FAS patients who were either re-treated or switched to canakinumab during the 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.||mg/L||Standard Deviation|Mean
813599|NCT01080131|Secondary|High-sensitivity C-reactive Protein (hsCRP) Levels for Participants Re-treated With or Switched to Canakinumab|"High sensitivity C-reactive protein (hsCRP) levels in blood serum were measured by a central laboratory in order to identify the presence of inflammation, to determine its severity, and to monitor the response to treatment.
Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2."|24 hours, 72 hours, 7 days, 4, 8 and 12 weeks post-dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.|Modified Analysis Set (MAS) consisting of all FAS patients who were either re-treated or switched to canakinumab during the 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.||mg/L||Standard Deviation|Mean
813600|NCT01080131|Secondary|Physician's Assessment of Erythema for Participants Re-treated or Switched to Canakinumab|"The study physician assessed the most affected joint for erythema (redness of the skin) as either present, absent or not assessable.
Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2."|72 hours post-dose and 7 days post dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.|Modified Analysis Set (MAS) consisting of all FAS patients who were either re-treated or switched to canakinumab during the 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.||percentage of participants|||Number
813601|NCT01080131|Secondary|Physician's Assessment of Joint Swelling for Participants Re-treated or Switched to Canakinumab|"The study physician assessed the most affected joint for swelling on the following 4-point scale:
no swelling;
palpable;
visible;
bulging beyond the joint margins.
Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2."|72 hours post-dose and 7 days post dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.|Modified Analysis Set (MAS) consisting of all FAS patients who were either re-treated or switched to canakinumab during the 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.||percentage of participants|||Number
813602|NCT01080131|Secondary|Physician's Assessment of Joint Tenderness for Participants Re-treated or Switched to Canakinumab|"The study physician assessed the most affected joint for tenderness on the following 4-point scale:
no pain;
participant states that there is pain;
participant states there is pain and winces;
participant states there is pain, winces and withdraws on palpation or passive movement of the affected study joint.
Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2."|72 hours post-dose and 7 days post dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.|Modified Analysis Set (MAS) consisting of all FAS patients who were either re-treated or switched to canakinumab during the 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.||percentage of participants|||Number
813603|NCT01080131|Secondary|Physician's Global Assessment of Response to Treatment for Participants Re-treated or Switched to Canakinumab|"The study physician made a global assessment of the patient’s response to treatment using a 5-point Likert scale: very good, good, fair, poor or very poor.
The physician completed the physician’s global assessment of response to treatment without viewing any of the patient’s assessments.
Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2."|72 hours post-dose and 7 days post dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.|Modified Analysis Set (MAS) consisting of all FAS patients who were either re-treated or switched to canakinumab during the 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.||percentage of participants|||Number
813604|NCT01080131|Secondary|Patient's Global Assessment of Response to Treatment for Participants Re-treated or Switched to Canakinumab|Participants made a global assessment of response to treatment using a 5-point Likert scale: Excellent, good, acceptable, slight or poor. Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2.|72 hours post-dose and 7 days post dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.|Modified Analysis Set (MAS) consisting of all FAS patients who were either re-treated or switched to canakinumab during the 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.||percentage of participants|||Number
813613|NCT01080131|Secondary|Physician’s Assessment of Tenderness, Swelling, and Erythema of the Most Affected Joint|The study physician assessed the most affected joint for: Tenderness on a 0-3 point scale: No pain, patient states that “there is pain”, patient states “there is pain and winces”, and patient states “there is pain, winces, and withdraws” on palpation or passive movement of the affected study joint; Swelling on a 0-3 point scale: No swelling, palpable, visible, and bulging beyond the joint margins; and Erythema: Present or absent. The percentage of participants in each category is reported.|72 hours post-dose and 24 weeks post-dose|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. 'N' in each category indicates participants with observations available at the specified time point.||percentage of participants|||Number
813605|NCT01080131|Secondary|Patient's Assessment of Gout Pain Intensity for Participants Re-treated or Switched to Canakinumab|"Participants scored their current pain intensity in the most affected joint of the gout flare on a 5-point Likert Scale (none, mild, moderate, severe or extreme).
Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2."|72 hours post-dose and 7 days post dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.|Modified Analysis Set (MAS) consisting of all FAS patients who were either re-treated or switched to canakinumab during the 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.||percentage of participants|||Number
813606|NCT01080131|Secondary|Flare Rate Per Year|"Flare rate was calculated as the number of new flares over the period of observation in years. Flare rate was calculated using only those new flares before switching to canakinumab.
Participants met the definition of new flare if they had:
Flare in joint, not a previously affected joint (at baseline or during study)
Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.
Participants did not meet criterion of having new gout flare if:
• Increasing/renewed gout pain in an affected joint before the flare has resolved completely.
Flare rates were estimated from a negative binomial model with body mass index at baseline as a covariate."|From randomization to the end of the second extension period (72 weeks).|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.||flares per patient per year||95% Confidence Interval|Mean
813607|NCT01080131|Secondary|Time to First New Flare: Survival Analysis by Treatment Over 72 Weeks|"Kaplan-Meier estimates of time to first new flare and confidence intervals were determined. For patients with event, time to event = (date of event - date of first dose of study drug + 1).
Patients met definition of new flare if they had:
Flare in joint, not a previously affected joint (at baseline or during study)
Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.
Patients did not meet criterion of having new gout flare if:
• Increasing/renewed gout pain in an affected joint before flare has resolved completely."|From randomization to the end of the second extension period (72 weeks).|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.||days||95% Confidence Interval|Median
813608|NCT01080131|Secondary|Percentage of Patients With Maximum Severity of New Gout Flares as Severe or Extreme|For each new flare, participants scored the maximum amount of acute gout pain in the most affected joint since the onset of the new flare and the time they were re-dosed on a 5 point Likert scale as None, Mild, Moderate, Severe or Extreme. The percentage of participants with a maximum new flare severity of severe or extreme is reported for the first post-baseline flare that occurred during the 12-week core study and for the last post-baseline flare that occurred up until the end of the first extension period.|From the onset of a new flare until re-dosing. First post-baseline new flare during 12 week core study and the last post-baseline flare that occurred up until the end of the first extension study (24 weeks).|The number of participants analyzed (indicated by 'N') for the first new post-baseline flare includes patients who were re-treated for a new flare during the 12-week core study. For the last post-baseline flare the population analyzed includes patients re-treated for at least one new flare during the first 24 weeks.||Percentage of participants|||Number
813609|NCT01080131|Secondary|Patient's Assessment of Gout Pain Intensity in the Most Affected Joint|Participant scored their current pain intensity in the most affected joint of the gout flare on a 5-point Likert Scale (none, mild, moderate, severe, extreme).|72 hours post-dose and 24 weeks post-dose|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. 'N' in each category indicates participants with observations available at the specified time point.||percentage of participants|||Number
813610|NCT01080131|Secondary|High-sensitivity C-reactive Protein (hsCRP) and Serum Amyloid A Protein (SAA) Levels|High sensitivity C-reactive protein (hsCRP) and serum amyloid A (SAA) were determined in blood serum in order to identify the presence of inflammation, to determine its severity, and to monitor the response to treatment. Analyses were measured by a central laboratory. The analysis included treatment group, log-transformed protein level at baseline, and body mass index (BMI) at baseline as covariates.|72 hours after the first dose for the baseline flare and 72 hours post-dose for the last post-baseline flare that occurred up until the end of the first extension study (24 weeks).|"For the Baseline flare the population analyzed consisted of the Full Analysis Set (FAS). For the last post-baseline flare the population analyzed consisted of patients re-treated for at least one new flare. N indicates the number of participants with available data in each analysis."||mg/L||95% Confidence Interval|Least Squares Mean
813611|NCT01080131|Primary|Number of Participants With Adverse Events, Death and Serious Adverse Events (72 Weeks Overall)|This was the primary endpoint of extension study 2. An adverse event was defined as any unfavorable and unintended diagnosis, symptom sign including an abnormal laboratory finding, syndrome or disease which either occurs during the study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse event is defined as any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.|72 weeks|Safety population consisted of all patients who received study drug in the core study and had at least one post-baseline safety assessment.||participants|||Number
813612|NCT01080131|Secondary|Physician’s Assessment of Range of Motion of the Most Affected Joint|The study physician assessed the range of motion of the most affected joint for range of motion on a 5-point Likert scale: Normal, mildly restricted, moderately restricted, severely restricted, immobilized. The percentage of participants in each category is reported.|72 hours post-dose and 24 weeks post-dose|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. 'N' in each category indicates participants with observations available at the specified time point.||percentage of participants|||Number
814964|NCT01092663|Primary|Fasting Endogenous Glucose Production|Change from baseline in fasting endogenous glucose production after 12 weeks of colesevelam alone or colesevelam plus sitagliptin treatment|baseline and 12 weeks|||micromoles (umol) per kg FFM per min||Standard Deviation|Mean
813614|NCT01080131|Secondary|Patient’s Global Assessment of Response to Treatment|Participants made a global assessment of response to treatment using a 5-point Likert scale: Excellent, good, acceptable, slight, poor. The percentage of participants in each category is reported.|72 hours post-dose and 24 weeks post-dose|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. 'N' in each category indicates participants with observations available at the specified time point.||percentage of participants|||Number
813615|NCT01080131|Primary|Number of Participants With Adverse Events, Death and Serious Adverse Events During 24 Weeks|This was primary endpoint of extension study 1. Adverse event is defined as any unfavorable and unintended diagnosis, symptom sign including an abnormal laboratory finding, syndrome or disease which either occurs during the study, having been absent at baseline, or, if present at baseline, appears to worsen. A serious adverse event is defined as any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.|During 24 weeks overall|Safety population consisted of all patients who received study drug in the core study and had at least one post-baseline safety assessment||Participants|||Number
813616|NCT01080131|Secondary|Physician’s Global Assessment of Response to Treatment|The study physician made a global assessment of the patient’s response to treatment using a 5-point Likert scale: Very good, good, fair, poor, very poor. The percentage of patients in each category is reported. The physician completed the assessment without viewing any of the patient’s own assessments (pain intensity and patient’s global assessment of response to treatment).|72 hours post-dose and 24-weeks post-dose.|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. 'N' in each category indicates participants with observations available for this endpoint at the specified time point.||percentage of participants|||Number
813617|NCT01080131|Secondary|Amount of Rescue Medication Taken|"Patients who had difficulty in tolerating their pain were allowed to take rescue medication after the 6-hour post-dose pain assessments as follows:
Acetaminophen (paracetamol) 500 mg and/ or codeine 30 mg as required. A maximum of 1 g/dose or 3 g/day of acetaminophen and 30 mg/ dose or 180 mg/day of codeine was allowed.
If they had insufficient pain relief, patients were allowed to take a maximum of 30 mg of oral prednisolone as required per day for 2 days followed by up to 20 mg of prednisolone as required subsequent days within 7 days of a gout flare."|For 7 days after the first dose for the baseline flare and 7 days post-dose for the last post-baseline flare that occurred up until the end of the first extension study (24 weeks).|For the Baseline flare the population analyzed consisted of the Full Analysis Set (FAS). For the last post-baseline flare the population analyzed consisted of patients re-treated for at least one new flare.||mg||Standard Deviation|Mean
813618|NCT01080131|Secondary|Percentage of Participants Who Took Rescue Medication|"Participants who had difficulty in tolerating their pain were allowed to take rescue medication after the 6-hour post-dose pain assessments as follows:
Acetaminophen (paracetamol) 500 mg and/ or codeine 30 mg as required. A maximum of 1 g/dose or 3 g/day of acetaminophen and 30 mg/ dose or 180 mg/day of codeine was allowed.
If they had insufficient pain relief, participants were allowed to take a maximum of 30 mg of oral prednisolone as required per day for 2 days followed by up to 20 mg of prednisolone as required subsequent days within 7 days of a gout flare.
Use of these treatments during the first 7 days of a gout flare was recorded as rescue medication."|For 7 days after the first dose for the baseline flare and 7 days post-dose for the last post-baseline flare that occurred up until the end of the first extension study (24 weeks).|For the Baseline flare the population analyzed consisted of the Full Analysis Set (FAS). For the last post-baseline flare the population analyzed consisted of patients re-treated for at least one new flare.||percentage of participants|||Number
813619|NCT01080131|Secondary|Time to First Intake of Rescue Medication|"Participants who had difficulty in tolerating their pain were allowed to take rescue medication after the 6-hour post-dose pain assessments as follows:
Acetaminophen (paracetamol) 500 mg and/ or codeine 30 mg as required. A maximum of 1 g/dose or 3 g/day of acetaminophen and 30 mg/ dose or 180 mg/day of codeine was allowed.
If they had insufficient pain relief, participants were allowed to take a maximum of 30 mg of oral prednisolone as required per day for 2 days followed by up to 20 mg of prednisolone as required subsequent days within 7 days of a gout flare.
Use of these treatments during the first 7 days of a gout flare was recorded as rescue medication.
Kaplan-Meier estimates of the time to first intake of rescue medication, in hours, and the confidence interval were determined for the flare experienced at study entry (Baseline flare) and the last new flare (last post-baseline flare) that occurred up until the end of the first extension period (24 weeks)."|For 7 days after the first dose for the baseline flare and 7 days post-dose for the last post-baseline flare that occurred up until the end of the first extension study (24 weeks).|For the Baseline flare the population analyzed consisted of the Full Analysis Set (FAS). For the last post-baseline flare the population analyzed consisted of patients re-treated for at least one new flare. Patients who did not take rescue medication had the time-to-first rescue medication intake censored at 7 days post dosing and re-dosing.||hours||95% Confidence Interval|Median
813620|NCT01080131|Secondary|Mean Number of New Gout Flares Per Patient During 24 Weeks|"Patients met definition of new flare if they had:
Flare in joint, not a previously affected joint(at baseline or during study)
Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.
Participants did not meet the criterion of having a new gout flare if they had increasing/renewed gout pain in an affected joint before the flare had resolved completely."|24 weeks|Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.||new flares per patient||Standard Deviation|Mean
813621|NCT01080131|Secondary|Time to the First New Gout Flare During 24 Weeks|"Kaplan-Meier (KM) estimates of the time to first new flare and confidence intervals were determined. Participants met the definition of a new flare if they had:
Flare in joint, not a previously affected joint (at baseline or during study)
Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.
Participants did not meet the criterion of having a new gout flare if they had increasing/renewed gout pain in an affected joint before the flare had resolved completely."|From randomization to the end of the first extension period (24 weeks).|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.||days||95% Confidence Interval|Median
813622|NCT01080131|Secondary|Self-assessed Pain Intensity in the Joint Most Affected at Last Post-Baseline Measured on a Visual Analog Scale (VAS)|Patient’s assessment of gout pain intensity in the most affected joint (on a 0-100 mm VAS) for the last post-baseline flare, ranging from no pain (0) to unbearable pain (100), was summarized up to 7 days after receiving a re-dose of study drug by time point. Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. The covariance analysis included treatment group, Baseline VAS score at that flare, and body mass index (BMI) at Baseline as covariates.|6, 12, 24, 48, and 72 hours; and 4, 5, 6, and 7 days post-dose for last post-baseline flare that occurred up until the end of the first extension study (24 weeks).|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. For assessments made up to 7 days after re-dosing, pain values were imputed using the Last- Observation-Carried-Forward (LOCF) method.||mm||Standard Error|Least Squares Mean
813623|NCT01080131|Secondary|Self-assessed Pain Intensity in the Joint Most Affected at Baseline Measured on a Visual Analog Scale (0-100 mm VAS)|Patients scored their pain intensity in the joint most affected at Baseline on a 0-100 mm VAS, ranging from no pain (0) to unbearable pain (100), from 6 hours to 7 days post-dose. Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. The ANCOVA analysis included treatment group, Baseline VAS score, and body mass index (BMI) at Baseline as covariates.|6, 12, 24, 48, and 72 hours; and 4, 5, 6, and 7 days post-dose (randomization)|Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.||mm||Standard Error|Least Squares Mean
813624|NCT01080131|Secondary|Pharmacokinetic Concentrations|Canakinumab concentration was analyzed in serum by means of a competitive Enzyme-linked immunosorbent assay (ELISA) assay with a lower limit of quantification (LOQ) at 100 ng/mL.|12 weeks post-dose|Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.||µg/mL||Standard Deviation|Mean
813625|NCT01080131|Primary|Self-assessed Pain Intensity in the Joint Most Affected at Baseline Measured on a Visual Analog Scale (VAS) at 72 Hours Post-dose|Patients scored their pain intensity in the joint most affected at Baseline on a 0-100 mm VAS, ranging from no pain (0) to unbearable pain (100), at 72 hours post-dose. Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. The analysis of covariance (ANCOVA) analysis included treatment group, Baseline VAS score, and body mass index (BMI) at Baseline as covariates.|72 hours post-dose (randomization)|Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. Last Observation Carried Forward (LOCF) method was used to impute post dose measurement.||mm||Standard Error|Least Squares Mean
813626|NCT01080131|Secondary|Percentage of Participants With at Least 1 New Gout Flare During the 12 Weeks of the Study|The percentage of participants who experienced at least 1 new gout flare during the 12 week study treatment period.|Baseline to Week 12|Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.||percentage of participants|||Number
813627|NCT01080131|Secondary|SF 36 Physical Function Score at Week 12|SF-36 measures impact of disease on overall quality of life (QoL). 36-item survey has 8 subscales that can be aggregated into physical and mental component summary scores. Scores are standardized with the use of norm-based methods based on assessment of the general U.S. population free of chronic conditions. Scores range from 1-100 with a mean=50 and a standard deviation=10. A higher score indicates less impact on QoL. Analysis of covariance (ANCOVA) model was used with treatment group and baseline SF-36 physical function subscore as covariates.|Week 12|Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. Participants with observations at Week 12 were included in the analysis.||Units on a scale||Standard Error|Least Squares Mean
813628|NCT01080131|Secondary|Time to Complete Resolution of Pain; Survival Analysis|Kaplan-Meier estimates of the time to complete resolution of self-assessed pain intensity in the joint most affected and the confidence interval was determined. Patients scored their pain intensity on a 5-point Likert scale (none, mild, moderate, severe, extreme). Pain was scored at Baseline; 6 and 12 hours; 1, 2, 3, 4, 5, 6, and 7 days post-dose.|Baseline to 7 days post-dose (randomization)|Full Analysis Set (FAS): All patients that received study drug.||hours||95% Confidence Interval|Number
813629|NCT01080131|Secondary|Time to at Least a 50% Reduction in Self-assessed Pain Intensity in the Joint Most Affected at Baseline Measured on a Visual Analog Scale (VAS)|Kaplan-Meier estimates of the time to at least a 50% reduction in self-assessed pain intensity in the joint most affected at Baseline and the confidence intervals were determined along with 95% confidence interval. Patients scored their pain intensity on a 0-100 mm VAS, ranging from no pain (0) to unbearable pain (100). Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. Pain was scored at Baseline; at 6 and 12 hours post-dose; and at 1, 2, 3, 4, 5, 6, and 7 days post-dose.|Baseline to 7 days post-dose (randomization)|Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. Last Observation Carried Forward (LOCF) method was used to impute post dose measurement.||hours||95% Confidence Interval|Median
813630|NCT01080131|Primary|Time to First New Flare: Survival Analysis During the 12 Weeks of Study|Kaplan-Meier estimates of time to first new flare and confidence intervals were determined. For patients with event, time to event = (date of event - date of first dose of study drug + 1). Patients met definition of new flare if they had: •Flare in joint, not a previously affected joint (at baseline or during study) •Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely. Patients did not meet criterion of having new gout flare if: • Increasing/renewed gout pain in an affected joint before flare has resolved completely.|Baseline to 12 weeks|Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.||Days||95% Confidence Interval|Median
813631|NCT01080209|Secondary|Number of Patients With Vision Loss in the Study Eye|Vision loss is assessed by Best Corrected Visual Acuity (BCVA) in the study eye. BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). Severe vision loss is a ≥30 letter decrease in BCVA. Moderate vision loss is a ≥15 and <30 letter decrease in BCVA. No or mild vision loss is <15 letter decrease in BCVA. Baseline of the parent study is defined as the point of the first study treatment.|Baseline of Parent Study, Month 36|Safety Population: all enrolled patients, who received a sham or active study treatment of intravitreal Brimonidine Tartrate PS DDS in the parent study||Patients|||Number
813632|NCT01080209|Primary|Number of Patients With No Visible Implants in the Study Eye|Implants administered during the parent study are evaluated during this study to determine if they have completely degraded. The time frame is evaluated from the point of the first treatment in the parent study.|Month 36|Safety Population: all enrolled patients, who received a sham or active study treatment of intravitreal Brimonidine Tartrate PS DDS in the parent study||Patients|||Number
813633|NCT01080248|Secondary|Overall Survival||1 year|||participants|||Number
813634|NCT01080248|Secondary|Median Survival||Length of follow-up was 35 weeks|||weeks||Full Range|Median
813635|NCT01080248|Secondary|Progression-free Survival (PFS)|"PFS is defined as the duration of time from start of treatment to time to progression.
Progressive disease - at least a 20% increase in the sum of the longest diameter of the target lesions taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions."|Follow-up was approximately 9 weeks|One participant was removed from study for adverse event prior to first response assessment.||weeks|||Number
813636|NCT01080248|Primary|Response Rate by RECIST Criteria.|"Response rate = complete response + partial response per RECIST
Complete response - disappearance of all target and non-target lesions.
Partial response - at least a 30% decrease in the sum of the longest diameter of the target lesions, taking as reference the baseline sum longest diameter"|Follow-up was approximately 9 weeks|One participant was removed from study for adverse event prior to first response assessment. The remaining participant had progressive disease per RECIST while on treatment.||percentage of participants|||Number
813637|NCT01080261|Secondary|Clinical Procedural Success (Percentage of Participants)|Expressed as percentage of participants in whom mean lesion diameter stenosis was <30% with TIMI 3 flow (visually assessed) and who did not experience an occurrence of in-hospital myocardial infarction, target vessel revascularization, or cardiac death.|While participant is in the hospital|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
813638|NCT01080261|Secondary|Technical Success (Percentage of Stents)|Defined as successful delivery and deployment of the study stent to the target vessel, without balloon rupture or stent embolization; expressed per stent|At time of index procedure|Analysis was intention to treat||percentage of stents|Participants||Number
813639|NCT01080261|Secondary|Definite + Probable Stent Thrombosis (ST) Based on Academic Research Consortium (ARC) Definition (Percentage of Participants With an Event)|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days)|>30 days - 9 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
813640|NCT01080261|Secondary|Definite + Probable Stent Thrombosis (ST) Based on Academic Research Consortium (ARC) Definition (Percentage of Participants With an Event)|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days)|0-30 Days (Early)|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
813641|NCT01080261|Secondary|Target Lesion Failure (TLF) (Percentage of Participants With an Event)|Target lesion failure (TLF) is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non–Q-wave) related to the target vessel, or cardiac death related to the target vessel. Reported as percentage of participants who experienced a TLF event.|9 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
813642|NCT01080261|Secondary|Target Vessel Failure (TVF) (Percentage of Participants With an Event)|Includes any ischemia-driven revascularization of the target vessel, myocardial infarction (MI, Q-wave and non–Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF. Reported as percentage of participants who experienced a TVF event.|9 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
813643|NCT01080261|Secondary|Target Lesion Revascularization (Percentage of Participants With an Event)|Target lesion revascularization (TLR) is any ischemia-driven repeat percutaneous intervention, to improve blood flow, of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion. Reported as percentage of participants who experienced a TLR.|9 months|Analysis was intention to treat; all participants underwent clinical follow-up to provide the information needed for this endpoint.||percentage of participants|||Number
813644|NCT01080261|Secondary|Target Vessel Revascularization (Percentage of Participants With an Event)|Target vessel revascularization (TVR) is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.Reported as percentage of participants who experienced a TVR.|9 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
813673|NCT01080794|Secondary|Clinical Anxiety Scale (CAS)|To evaluate anxiety in Parkinson's Disease. The CAS mean scores were reported for each group at each time point. The CAS Score Range is 0 - 100, where higher the score indicates greater severity of the anxiety symptoms.|Pre-treatment; Post-treatment 0,1,3, and 6 months.|||units on a scale||Standard Deviation|Mean
813645|NCT01080261|Secondary|Cardiac Death (Percentage of Participants With an Event)|Cardiac death is defined as death due to any of the following: acute myocardial infarction; cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded. Reported as percentage of participants who experienced cardiac death.|9 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
813646|NCT01080261|Secondary|All-cause Death (Percentage of Participants With an Event)|Participants who died from any cause|9 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
813647|NCT01080261|Secondary|Myocardial Infarction (MI) (Percentage of Participants With an Event)|New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase- myoglobin band (CK-MB) or troponin above upper limit of normal (ULN) (baseline troponin <ULN); if no new Q-waves total CK or troponin >3× ULN (baseline troponin <ULN) plus at least one of the following: electrocardiogram changes indicating new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium, or new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5× ULN|9 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
813648|NCT01080261|Primary|Major Adverse Cardiac Events (MACE) (Percentage of Participants With an Event)|A major adverse cardiac event (MACE) is defined as any ischemia-driven target lesion revascularization (TLR), myocardial infarction (MI, Q-wave and non-Q-wave), or cardiac death. Reported as percentage of participants who have experienced a MACE event.|9 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
813649|NCT01080300|Primary|Evaluate Efficacy of G-ER at 1800mg Daily Compared With Placebo in Reducing the Average Daily Severity Score of Moderate to Severe Hot Flashes at Weeks 4 & 12 of the Efficacy Treatment Period, Compared With Baseline.|"To assess the efficacy of G-ER dosed at 1800mg daily(600mg AM, 1200mg PM), compared with placebo in reducing the average daily severity score of moderate to severe hot flashes in post menopausal women (score defined as Mild (1), Moderate (2), and Severe (3)) at Week 4 of the efficacy treatment period compared with Baseline and at Week 12 of the efficacy treatment period compared with Baseline."|Baseline, Week 4, and Week 12|Intent-to-treat (ITT) Population||scores on a scale||95% Confidence Interval|Least Squares Mean
813650|NCT01080300|Secondary|Evaluate Safety of G-ER|Evaluate safety of G-ER,change from average daily frequency & severity score of HFs from baseline to end point(wk 24),assess sleep interference, depression,suicidal ideation, quality of life, patient and investigator global impression of change|6mt treatment, 1mt f/u||||||
813651|NCT01080300|Primary|Evaluate Efficacy of G-ER at 1800mg Daily Compared With Placebo in Reducing the Average Daily Frequency of Moderate to Severe Hot Flashes at Weeks 4 & 12 of the Efficacy Treatment Period, Compared With Baseline.|To assess the efficacy of G-ER dosed at 1800mg daily(600mg AM, 1200mg PM), compared with placebo in reducing the average daily frequency of moderate to severe hot flashes in post menopausal women at Week 4 of the efficacy treatment period compared with Baseline and at Week 12 of the efficacy treatment period compared with Baseline.|Baseline, Week 4, and Week 12|Intent-to-treat (ITT) Population||hot flashes||95% Confidence Interval|Least Squares Mean
813652|NCT01080326|Primary|Number of Participants Completing Natural Orifice Translumenal Endoscopic Surgical (NOTES) Repair|"At the time of surgery the repair was pressure tested using endoscopic insufflation. Two days post-operation all participants receiving the NOTES repair underwent a water-soluble contrast study to demonstrate leakage.
Note: The NOTES procedure was attempted first if the subject had no contraindication. If this proved unsuccessful the surgical team proceeded with conversion to laparoscopic or open standard surgical therapy as indicated."|2 days post-operation|||participants|||Number
813653|NCT01080391|Secondary|QLQ-C30 Global Health Status/Quality of Life Scores|European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Core Module QLQ-C30 (QLQ-C30 GHS/QoL) is a validated instrument in multiple myeloma patients. Scores range from 0 to 100, with higher scores indicating better health related quality of life. The minimal important difference for between group differences is 5 points.|Day 1 of Cycles 3, 6, 12, 18|ITT analysis set comprised of all randomized participants.||scores on a scale||Standard Deviation|Mean
813654|NCT01080391|Secondary|Duration of Disease Control|Duration of disease control (DDC) was calculated for participants who achieved disease control.DDC was defined as the time in months from randomization to the earlier of documented Progressive disease (PD) or death due to any cause. Participants who had not progressed or died were censored according to the censoring rules defined previously for PFS.|From randomization through the data cutoff date of 16 June 2014. Longest follow-up time was approximately 46 months.|The Intent to treat (ITT) population with participantants who achieved disease control.||months||95% Confidence Interval|Median
813655|NCT01080391|Secondary|Duration of Response|Duration of response (DOR) was calculated for subjects who achieved a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR). Duration of response was defined as the time in months from the initial start of response (PR or better) to the earlier of documented Progressive disease (PD) or death due to any cause. Participants who had not progressed or died were censored according to the censoring rules defined previously for PFS.|From randomization through the data cutoff date of 16 June 2014. Longest follow-up time was approximately 42 months.|The Intent to treat (ITT) population with participantant with participants who achieved a best overall response of PR or better.||months||95% Confidence Interval|Median
813656|NCT01080391|Secondary|Disease Control|Number of participants who achieved a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), minimal response (MR), or stable disease (SD) lasting ≥ 8 weeks according to International Myeloma Working Group - Uniform Response Criteria (IMWG-URC) (MR was determined using European Group for Blood and Marrow Transplantation criteria).|From randomization through the data cutoff date of 16 June 2014. Median follow-up time was approximately 31 months.|ITT analysis set comprised of all randomized participants||participants|||Number
813657|NCT01080391|Secondary|Overall Response|Number of participants who achieved confirmed stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) as their best response based on the Independent Review Committee (IRC) assessed response outcome. Response was determined using the International Myeloma Working Group - Uniform Response Criteria (IMWG-URC).|From randomization through the data cutoff date of 16 June 2014.Median follow-up time was approximately 31 months.|ITT analysis set comprised of all randomized participants||participants|||Number
813658|NCT01080391|Secondary|Overall Survival|Time elapsed between the randomization date and the date of death. Participants who were still alive were censored at the date when the subject was last known to be alive or the data cutoff date, whichever occurs earlier. The median and all but one of the 95% confidence limits were not estimable. Instead, the number of participants who died or were censored are reported.|From randomization through the data cutoff date of 16 June 2014. Median follow up time was approximiately 32 months.|ITT analysis set comprised of all randomized participants||participants|||Number
813659|NCT01080391|Primary|Progression-free Survival (PFS)|Kaplan-Meier estimate of median time from randomization to progressive disease (PD) or all-cause death. PD was assessed using International Myeloma Working Group-Uniform Response Criteria (IMWG-URC). 1 or more conditions were required to meet PD: 2 consecutive rising serum or urine M-protein from central lab; documented new bone lesion(s) or soft tissue plasmacytoma(s) or increased size of existing bone lesion(s) or plasmacytoma(s); or confirmed hypercalcemia due solely to plasma cell proliferative disorder (local lab greater than 11.5 mg/dL on 2 separate occasions). Censoring conditions (censoring dates) were: no post-baseline disease assessment (DA) (randomization date); started non-protocol systemic anticancer treatment before PD or death (last DA date before such treatment); died or had PD after more than 1 missed DA (last DA date without PD before the first missed visit); or were alive and without documentation of PD, including lost to follow-up without PD (last DA date).|From randomization through the data cutoff date of 16 June 2014. Median follow-up time was approximately 31 months.|ITT analysis set comprised of all randomized participants||months||95% Confidence Interval|Median
813660|NCT01080625|Primary|Occurrence of Postreperfusion Syndrome (PRS)|the number of patients who showed PRS (hypotension defined as < 30% of baseline mean arterial pressure [MAP] lasting over 1 min immediately after reperfusion of liver graft) was divided by the total number of patients enrolled for each group|immediately after reperfusion|Initial assessment for eligibility: n=128 32 patients who did not meet the criteria were excluded 96 patients were randomized Contorol (32 patients) --> 1 patient was excluded because of portalvein rupture Epinephrine (33 patients) --> data recording error (1 patient) practice error (1 patient) Phenylephrine group (31 patient)||percentage of participants|||Number
813661|NCT01080677|Secondary|Percentage of Participants With Treatment Satisfaction|Following up to 24 hours after treatment, participants were asked to report whether they were satisfied with level of pain relief provided by treatment|24 hours|||percentage of participants|||Number
813662|NCT01080677|Secondary|Percentage of Participants Experiencing at Least One Adverse Event of Interest|Adverse events may have included abdominal pain, flushing, dizziness, insomnia, or anxiety|24 hours|||percentage of participants|||Number
813663|NCT01080677|Secondary|Percentage of Participants Pain Free at 2 Hrs Post First Administration of Caffeine/Propranolol||2 hours|||percentage of participants|||Number
813664|NCT01080677|Primary|Percentage of Participants Reporting Pain Relief at 2 Hrs Post First Administration of Caffeine/Propranolol (Defined as a Decrease in Headache Pain Intensity From Severe or Moderate Headache Pain at Baseline to Mild or no Pain at 2 Hrs)||2 hours|||percentage of participants|||Number
813665|NCT01080768|Primary|Change in the Ankle Foot Volume (AFV) as Measured by Displacement Method|AFV (mL) was measured using the principle of water displacement using a commercially available foot volumeter. The amount of water displaced in milliliters (mL) equals the volume of the foot/ankle. The study was terminated due to the publication of the results of a near identical study by Fogari et al. Hence, for the current study, no analysis was performed.|Baseline, 4 weeks|The study was terminated due to the publication of the results of a near identical study by Fogari et al. Hence, for the current study, no analysis was performed.||mL||Standard Error|Least Squares Mean
813666|NCT01080794|Secondary|The Number All Types of Adverse Events.|To establish the safety and tolerability of rTMS in Parkinson's Disease.|Baseline through Month 6|||incidents of an adverse event|||Number
813667|NCT01080794|Secondary|Global Impression Scales|To assess symptom severity and treatment response in Parkinson's Disease. The CGI mean scores were reported for each group at each time point. The CGI Score Range is 1 - 8, where higher the score indicates greater severity of illness or worsening of illness.|Pre-treatment; Post-treatment 0,1,3, and 6 months.|||units on a scale||Standard Deviation|Mean
813668|NCT01080794|Secondary|Beck Depression Inventory (BDI-II)|To assess mood symptoms in Parkinson's Disease. The BDI-II mean scores were reported for each group at each time point. The BDI-II Score Range is 0 - 63, where higher the score indicates greater severity of the mood symptoms.|Pre-treatment; Post-treatment 0,1,3, and 6 months.|||units on a scale||Standard Deviation|Mean
813669|NCT01080794|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) Parts I, II, and IV|"To assess apathy, cognition, depression, activities of daily living (ADL), quality of life (QOL), and motor symptoms in Parkinson's Disease.
The UPDRS I, II, IV total mean scores were reported for each group at each time point. The UPDRS I, II, IV scores were added together for each patient, with a total score range of 0 - 91, where higher the score indicates greater severity of the symptoms."|Pre-treatment; Post-treatment 0,1,3, and 6 months.|||units on a scale||Standard Deviation|Mean
813670|NCT01080794|Secondary|Montreal Cognitive Assessment (MoCA)|To screen and follow cognitive function in Parkinson's Disease. The MoCA mean scores were reported for each group at each time point. The MoCA Score Range is 0 - 30, where 26-30 indicates normal cognition.|pre-treatment; 0,1,3, and 6 months post-treatment|||units on a scale||Standard Deviation|Mean
813671|NCT01080794|Secondary|Parkinson's Disease Questionnaire 39 (PDQ-39)|To assess the quality of life (QOL) in Parkinson's Disease. The PDQ-39 mean scores were reported for each group at each time point. The PDQ-39 Score Range is 0 - 156, where higher the score indicates greater impact on quality of life.|Pre-treatment; Post-treatment 0,1,3, and 6 months.|||units on a scale||Standard Deviation|Mean
813672|NCT01080794|Secondary|Apathy Evaluation Scale (AES)|To evaluate apathy in Parkinson's Disease. The AES mean scores were reported for each group at each time point. The AES Score Range is 0-42, where higher the score indicates greater severity of the apathy symptoms.|Pre-treatment; Post-treatment 0,1,3, and 6 months.|||units on a scale||Standard Deviation|Mean
813676|NCT01080807|Secondary|Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Intimacy|FOSQ-10 consists of 10 questions rated on a scale of 1-4 (1=extreme difficulty, 4=no difficulty), and is used to measure the impact of daytime sleepiness on activities of daily living and quality of life. A total score and 5 subscale (vigilance, general productivity, social outcome, intimacy, and activity level) scores are calculated from the responses. Worst subscale score is 1 (maximum difficulty) and the best score is 4 (no difficulty). This score represents the CHANGE from Baseline in the Intimacy subscale. Positive change scores represent improvement (possible range -3 to +3).|Baseline and week 6 (or last observation after baseline)|Full analysis set defined as subjects who were assessed with FOSQ-10 at baseline and at endpoint||Units on a scale||Standard Error|Least Squares Mean
813677|NCT01080807|Secondary|Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Social Outcome|FOSQ-10 consists of 10 questions rated on a scale of 1-4 (1=extreme difficulty, 4=no difficulty), and is used to measure the impact of daytime sleepiness on activities of daily living and quality of life. A total score and 5 subscale (vigilance, general productivity, social outcome, intimacy, and activity level) scores are calculated from the responses. Worst subscale score is 1 (maximum difficulty) and the best score is 4 (no difficulty). This score represents the CHANGE from Baseline in the Social Outcome subscale. Positive change scores represent improvement (possible range -3 to +3).|Baseline and week 6 (or last observation after baseline)|Full analysis set defined as subjects who were assessed with FOSQ-10 at baseline and at endpoint||Units on a scale||Standard Error|Least Squares Mean
813678|NCT01080807|Secondary|Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Vigilance Score|FOSQ-10 consists of 10 questions rated on a scale of 1-4 (1=extreme difficulty, 4=no difficulty), and is used to measure the impact of daytime sleepiness on activities of daily living and quality of life. A total score and 5 subscale (vigilance, general productivity, social outcome, intimacy, and activity level) scores are calculated from the responses. Worst subscale score is 1 (maximum difficulty) and the best score is 4 (no difficulty). This score represents the CHANGE from Baseline in the Vigilance subscale. Positive change scores represent improvement (possible range -3 to +3).|Baseline and week 6 (or last observation after baseline)|Full analysis set defined as subjects who were assessed with FOSQ-10 at baseline and at endpoint||Units on a scale||Standard Error|Least Squares Mean
813679|NCT01080807|Secondary|Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) General Productivity Score|FOSQ-10 consists of 10 questions rated on a scale of 1-4 (1=extreme difficulty, 4=no difficulty), and is used to measure the impact of daytime sleepiness on activities of daily living and quality of life. A total score and 5 subscale (vigilance, general productivity, social outcome, intimacy, and activity level) scores are calculated from the responses. Worst subscale score is 1 (maximum difficulty) and the best score is 4 (no difficulty). This score represents the CHANGE from Baseline in the General Productivity subscale. Positive change scores represent improvement (possible range -3 to +3).|Baseline and week 6 (or last observation after baseline)|Full analysis set defined as subjects who were assessed with FOSQ-10 at baseline and at endpoint||Units on a scale||Standard Error|Least Squares Mean
813680|NCT01080807|Secondary|Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Activity Level Score|FOSQ-10 consists of 10 questions rated on a scale of 1 to 4 (1=extreme difficulty and 4=no difficulty), and is used to measure the impact of daytime sleepiness on activities of daily living and quality of life. A total score and 5 subscale (vigilance, general productivity, social outcome, intimacy, and activity level) scores are calculated from the responses. Worst subscale score is 1 (maximum difficulty) and the best score is 4 (no difficulty). This score represents the CHANGE from Baseline in the Activity level subscale. Positive change scores represent improvement (possible range -3 to +3).|Baseline and week 6 (or last observation after baseline)|Full analysis set defined as subjects who were assessed with FOSQ-10 at baseline and at endpoint||Units on a scale||Standard Error|Least Squares Mean
813681|NCT01080807|Secondary|Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Total Score|FOSQ-10 consists of 10 questions, on a scale of 1-4(1=extreme difficulty 4=no difficulty), measures impact of sleepiness on activities of daily living. Lower score = more difficulty with activity due to lack of sleep. Total score = MEAN of subscale scores (vigilance, productivity, social outcome, intimacy, activity) multiplied by 5. Worst total score is 5 (maximum difficulty) the best is 20 (no difficulty). This data reports CHANGE in total score from baseline to endpoint, with higher (positive) values representing improvement. Worst possible CHANGE value would be -15 best would be +15.|Baseline and week 6 (or last observation after baseline)|Full analysis set defined as subjects who were assessed with FOSQ-10 at baseline and at endpoint||Units on a scale||Standard Error|Least Squares Mean
813682|NCT01080807|Secondary|Treatment Satisfaction Questionnaire for Medication (TSQM)- Global Satisfaction Score at Endpoint|TSQM is a 14 question questionnaire assessing satisfaction with the medication. 4 scales are generated: side effects, effectiveness, convenience, and global satisfaction. Subjects responded to the questionnaire at Week 3, Week 6, and last observation after baseline. Optional responses are: Extremely Dissatisfied, Very Dissatisfied, Dissatisfied, Somewhat Satisfied, Satisfied, Very Satisfied, and Extremely Satisfied. From the responses, a scale score from 0 - 100 is calculated, with a higher score indicating greater satisfaction. Results from the Global Satisfaction scale are presented here.|Endpoint|Full analysis set defined as subjects who completed the TSQM at Endpoint (Week 6 or last observation after baseline)||Units on a scale||Standard Error|Least Squares Mean
813683|NCT01080807|Secondary|Treatment Satisfaction Questionnaire for Medication (TSQM)- Convenience Score at Endpoint|TSQM is a 14 question questionnaire assessing satisfaction with the medication. 4 scales are generated: side effects, effectiveness, convenience, and global satisfaction. Subjects responded to the questionnaire at Week 3, Week 6, and last observation after baseline. Optional responses are: Extremely Dissatisfied, Very Dissatisfied, Dissatisfied, Somewhat Satisfied, Satisfied, Very Satisfied, and Extremely Satisfied. From the responses, a scale score from 0 - 100 is calculated, with a higher score indicating greater satisfaction. Results from the Convenience scale are presented here.|Endpoint|Full analysis set defined as subjects who completed the TSQM at Endpoint (Week 6 or last observation after baseline)||Units on a scale||Standard Error|Least Squares Mean
813773|NCT01081145|Secondary|Percent of Subjects With an Assessment of Normal/Borderline Mentally Ill on CGI-S Scale During the Open-Label Phase - LOCF|CGI-S assesses the severity of the subject's condition on a 7-point scale: 1 (normal, not at all ill), 2 (borderline mentally ill), 3 (mildly ill), 4 (moderately ill), 5 (markedly ill), 6 (severely ill), 7 (among the most extremely ill)|13 weeks|Open-label FAS||percentage of participants|||Number
813684|NCT01080807|Secondary|Treatment Satisfaction Questionnaire for Medication (TSQM)- Side Effects Score at Endpoint|TSQM is a 14 question questionnaire assessing satisfaction with the medication. 4 scales are generated: side effects, effectiveness, convenience, and global satisfaction. Subjects responded to the questionnaire at Week 3, Week 6, and last post-baseline observation. Optional responses are: Extremely Dissatisfied, Very Dissatisfied, Dissatisfied, Somewhat Satisfied, Satisfied, Very Satisfied, and Extremely Satisfied. From the responses, a scale score from 0 - 100 is calculated, with a higher score indicating greater satisfaction. Results from the Side Effects scale are presented here.|Endpoint|Full analysis set defined as subjects who completed the TSQM at Endpoint (Week 6 or last observation after baseline)||Units on a scale||Standard Error|Least Squares Mean
813685|NCT01080807|Secondary|Treatment Satisfaction Questionnaire for Medication (TSQM)- Effectiveness Score at Endpoint|TSQM is a 14 question questionnaire assessing satisfaction with the medication. 4 scales are generated: side effects, effectiveness, convenience, and global satisfaction. Subjects responded to the questionnaire at Week 3, Week 6, and last observation after baseline. Optional responses are: Extremely Dissatisfied, Very Dissatisfied, Dissatisfied, Somewhat Satisfied, Satisfied, Very Satisfied, and Extremely Satisfied. From the responses, a scale score from 0 - 100 is calculated, with a higher score indicating greater satisfaction. Results from the Effectiveness scale are presented here.|Endpoint|Full analysis set defined as subjects who completed the TSQM at Endpoint (Week 6 or last observation after baseline)||Units on a scale||Standard Error|Least Squares Mean
813686|NCT01080807|Secondary|Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Score - Number of Days of Reduced Productivity|"Mental-health related disability was assessed with the Modified Sheehan Disability Scale (MSDS). The MSDS has three 11-point items, and the participant is asked to rate, on a numerical scale, the extent to which emotional problems have disrupted her/his work, social life, and family life/home responsibilities over the last month. Each item is rated from 0, indicating not at all, to 10, indicating extremely. Scores for the items are summed for a possible score of 0 to 30. The MSDS was performed by the patient at the baseline visit, at Week 3, and at Week 6."|Baseline and week 6 (or last observation after baseline)|Full analysis set defined as subjects who were assessed with MSDS at baseline and at Endpoint.||Units on a scale||Standard Error|Least Squares Mean
813687|NCT01080807|Secondary|Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Score - Days Missed Work or Unable to Carry Out Responsibilities|"Mental-health related disability was assessed with the Modified Sheehan Disability Scale (MSDS). The MSDS has three 11-point items, and the participant is asked to rate, on a numerical scale, the extent to which emotional problems have disrupted her/his work, social life, and family life/home responsibilities over the last month. Each item is rated from 0, indicating not at all, to 10, indicating extremely. Scores for the items are summed for a possible score of 0 to 30. The MSDS was performed by the patient at the baseline visit, at Week 3, and at Week 6."|Baseline and week 6 (or last observation after baseline)|Full analysis set defined as subjects who were assessed with MSDS at baseline and at Endpoint.||Units on a scale||Standard Error|Least Squares Mean
813688|NCT01080807|Secondary|Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Family Life Item Score|"Mental-health related disability was assessed with the Modified Sheehan Disability Scale (MSDS). The MSDS has three 11-point items, and the participant is asked to rate, on a numerical scale, the extent to which emotional problems have disrupted her/his work, social life, and family life/home responsibilities over the last month. Each item is rated from 0, indicating not at all, to 10, indicating extremely. Scores for the items are summed for a possible score of 0 to 30. The MSDS was performed by the patient at the baseline visit, at Week 3, and at Week 6."|Baseline and week 6 (or last observation after baseline)|Full analysis set defined as subjects who were assessed with MSDS at baseline and at Endpoint.||Units on a scale||Standard Error|Least Squares Mean
813689|NCT01080807|Secondary|Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Social Life Item Score|"Mental-health related disability was assessed with the Modified Sheehan Disability Scale (MSDS). The MSDS has three 11-point items, and the participant is asked to rate, on a numerical scale, the extent to which emotional problems have disrupted her/his work, social life, and family life/home responsibilities over the last month. Each item is rated from 0, indicating not at all, to 10, indicating extremely. Scores for the items are summed for a possible score of 0 to 30. The MSDS was performed by the patient at the baseline visit, at Week 3, and at Week 6."|Baseline and week 6 (or last observation (or last observation after baseline))|Full analysis set defined as subjects who were assessed with MSDS at baseline and at Endpoint.||Units on a scale||Standard Error|Least Squares Mean
813690|NCT01080807|Secondary|Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Work Item Score|"Mental-health related disability was assessed with the Modified Sheehan Disability Scale (MSDS). The MSDS has three 11-point items, and the participant is asked to rate, on a numerical scale, the extent to which emotional problems have disrupted her/his work, social life, and family life/home responsibilities over the last month. Each item is rated from 0, indicating not at all, to 10, indicating extremely. Scores for the items are summed for a possible score of 0 to 30. The MSDS was performed by the patient at the baseline visit, at Week 3, and at Week 6."|Baseline and week 6 (or last observation after baseline)|Full analysis set defined as subjects who were assessed with MSDS at baseline and at Endpoint.||Units on a scale||Standard Error|Least Squares Mean
813691|NCT01080807|Secondary|Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Composite Score|"Mental-health related disability was assessed with the Modified Sheehan Disability Scale (MSDS). The MSDS has three 11-point items, and the participant is asked to rate, on a numerical scale, the extent to which emotional problems have disrupted her/his work, social life, and family life/home responsibilities over the last month. Each item is rated from 0, indicating not at all, to 10, indicating extremely. Scores for the items are summed for a possible score of 0 to 30. The MSDS was performed by the patient at the baseline visit, at Week 3, and at Week 6."|Baseline and week 6 (or last observation after baseline)|Full analysis set defined as subjects who were assessed with MSDS at baseline and at Endpoint.||Units on a scale||Standard Error|Least Squares Mean
813739|NCT01074944|Secondary|PAP: Mean Spleen Volume at Baseline, Weeks 26, 52||Baseline, Week 26, Week 52|PP population included all participants who were at least 80% compliant with IMP dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations. Here 'n' signifies number of participants with available data for specified category for each arm respectively.||MN||Standard Deviation|Mean
813692|NCT01080807|Secondary|Percentage of Patients With at Least Minimal Improvement From Baseline in the Clinical Global Impression of Change (CGI-C) Rating as Related to Late Shift Sleepiness at Week 6|The Clinical Global Impression of Change (CGI-C) is an assessment performed by the clinician, evaluating the change in the patient's symptoms over time. The clinician categorizes the change as: very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse. The data presented here represents the percentage of patients whose condition showed at least minimal improvement in the CGI-C rating as related to late shift sleepiness (defined as the period 0400-0800, including the commute home).|Baseline and week 6|Full analysis set defined as subjects who were assessed with CGI-C at baseline and at week 6||Percentage of participants|||Number
813693|NCT01080807|Secondary|Percentage of Patients With at Least Minimal Improvement From Baseline in the Clinical Global Impression of Change (CGI-C) Rating as Related to Late Shift Sleepiness at Week 3|The Clinical Global Impression of Change (CGI-C) is an assessment performed by the clinician, evaluating the change in the patient's symptoms over time. The clinician categorizes the change as: very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse. The data presented here represents the percentage of patients whose condition showed at least minimal improvement in the CGI-C rating as related to late shift sleepiness (defined as the period 0400-0800, including the commute home).|Baseline and week 3|Full analysis set defined as subjects who were assessed with CGI-C at baseline and at week 3||Percentage of participants|||Number
813694|NCT01080807|Secondary|Change From Baseline to Week 6 in the Mean Karolinska Sleepiness Scale (KSS) Score|"The Karolinska sleepiness scale is a 10-point scale, on which the participant has to mark his sleepiness during the previous 10 minutes. The scale ranges from 1, which indicates extremely alert, to 10, which indicates extremely sleepy, can't stay awake. The KSS was performed by the participant at the baseline visit, week 3, and week 6 (or early termination visit). The score recorded is the average of 3 assessments within ±15 minutes at 0400, 0600, and 0800. The data presented here represents the mean change from baseline in the KSS scores of each group."|Baseline and week 6|The number of participants analyzed represents the number of participants with evaluable data.||Units on a scale||Standard Error|Least Squares Mean
813695|NCT01080807|Secondary|Change From Baseline to Week 3 in the Mean Karolinska Sleepiness Scale (KSS) Score|"The Karolinska sleepiness scale is a 10-point scale, on which the participant has to mark his sleepiness during the previous 10 minutes. The scale ranges from 1, which indicates extremely alert, to 10, which indicates extremely sleepy, can't stay awake. The KSS was performed by the participant at the baseline visit, week 3, and week 6 (or early termination visit). The score recorded is the average of 3 assessments within ±15 minutes at 0400, 0600, and 0800. The data presented here represents the mean change from baseline in the KSS scores of each group."|Baseline and week 3|The number of participants analyzed represents the number of participants with evaluable data.||Units on a scale||Standard Error|Least Squares Mean
813696|NCT01080807|Secondary|Change From Baseline to Endpoint in the Mean Karolinska Sleepiness Scale (KSS) Score|"The Karolinska sleepiness scale is a 10-point scale, on which the participant has to mark his sleepiness during the previous 10 minutes. The scale ranges from 1, which indicates extremely alert, to 10, which indicates extremely sleepy, can't stay awake. The KSS was performed by the participant at the baseline visit, week 3, and week 6 (or early termination visit). The score recorded is the average of 3 assessments within ±15 minutes at 0400, 0600, and 0800. The data presented here represents the mean change from baseline in the KSS scores of each group."|Baseline and week 6 (or last observation after baseline)|The number of participants analyzed represents the number of participants with evaluable data.||Units on a scale||Standard Error|Least Squares Mean
813697|NCT01080807|Secondary|Change From Baseline to Week 6 in Global Assessment of Functioning|The Global Assessment of Functioning (GAF) is a numeric scale (0 through 100) used by the clinician to rate the social, occupational, and psychological functioning of the patient. A higher score indicates superior functioning and fewer symptoms. The data presented here represents the mean change from baseline in the GAF scores of each group.|Baseline and Week 6|The number of participants analyzed represents the number of participants with evaluable data.||Units on a scale||Standard Error|Least Squares Mean
813698|NCT01080807|Secondary|Change From Baseline to Week 3 in Global Assessment of Functioning|The Global Assessment of Functioning (GAF) is a numeric scale (0 through 100) used by the clinician to rate the social, occupational, and psychological functioning of the patient. A higher score indicates superior functioning and fewer symptoms. The data presented here represents the mean change from baseline in the GAF scores of each group.|Baseline and Week 3|The number of participants analyzed represents the number of participants with evaluable data.||Units on a scale||Standard Error|Least Squares Mean
813699|NCT01080807|Secondary|Change From Baseline to Endpoint in Global Assessment of Function (GAF) Score|The Global Assessment of Functioning (GAF) is a numeric scale (0 through 100) used by the clinician to rate the social, occupational, and psychological functioning of the patient. A higher score indicates superior functioning and fewer symptoms. The data presented here represents the mean change from baseline to endpoint in the GAF scores of each group.|Baseline and week 6 (or last observation after baseline)|The number of participants analyzed represents the number of participants with evaluable data.||Units on a scale||Standard Error|Least Squares Mean
813700|NCT01080807|Primary|Percentage of Patients With at Least Minimal Improvement From Baseline in the Clinical Global Impression of Change (CGI-C) Rating as Related to Late Shift Sleepiness at Endpoint|The Clinical Global Impression of Change (CGI-C) is an assessment performed by the clinician, evaluating the change in the patient's symptoms over time. The clinician categorizes the change as: very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse. The data presented here represents the percentage of patients whose condition showed at least minimal improvement in the CGI-C rating as related to late shift sleepiness (defined as the period 0400-0800, including the commute home).|Baseline and week 6 (or last observation after baseline)|The number of participants analyzed represents the number of participants with evaluable data.||Percentage of participants|||Number
813701|NCT01074931|Secondary|The Duration on Treatment Until Development of an Adverse Event Leading to Treatment Discontinuation or Until Escape From Treatment|As so few participants withdrew from lopinavir/ritonavir treatment, durations of lopinavir/ritonavir therapy required for 25 percent, 50 percent and 75 percent of participants could not be established. The numbers of participants in each subgroup who discontinued from treatment due to an adverse event are presented.|Month 3, 6, 12, 18|All participants who took at least one dose of lopinavir/ritonavir.||Participants|||Number
813702|NCT01074931|Secondary|Adverse Events Observed and Development of Lipodystrophy Lesion and Their Locations|The types of adverse events reported are summarized. The presence of lipodystrophy (abnormal body fat distribution) and its location was to be recorded. However, due to an oversight, there was not a place to record the location of lipodystrophy on the case report form. Doctors used clinical judgment to rate lipodystrophy in treatment-experienced participants. Study visits were to occur at approximately 3, 6, 12, and 18 months after starting treatment. The exact dates of each visit depended on the physician’s judgment, so data are reported for Visits 1 through 4 rather than by month.|Month 3, 6, 12, 18|The adverse event population includes all participants who took at least one dose of lopinavir/ritonavir (98). Lipodystrophy evaluations were performed in treatment-experienced participants (90), not treatment-naive participants (8).||Participants|||Number
813703|NCT01074931|Secondary|Number of Participants Who Missed Doses, Interrupt or Discontinue Regimen, and Experience Changes in Dosage or of Combination Regimen|Visits were to occur at approximately 3, 6, 12, and 18 months after starting treatment. The frequency with which each participant forgot to take their medication since the last visit and discontinuations of treatment and the reasons were documented at each visit and are summarized. The number of participants changing from lopinavir/ritonavir soft gel capsule to tablet are also presented. The exact dates of each visit depended on the physician’s judgment, so data are reported for Visits 1 through 4 rather than by month. Note: participants may have had multiple missed doses or therapy changes.|Month 3, 6, 12, 18|All participants who took at least one dose of lopinavir/ritonavir.||Participants|||Number
813704|NCT01074931|Primary|Evolution of the Tolerance Issues|At each study visit, treating physicians evaluated participants and used their clinical judgment to determine if they were tolerating the lopinavir/ritonavir-containing regimen. Study visits were to occur at approximately 3, 6, 12, and 18 months after starting treatment. The exact dates of each visit depended on the physician’s judgment, so data are reported for Visits 1 through 4 rather than by month.|Month 3, 6, 12, 18|All participants taking at least one dose of lopinavir/ritonavir.||Participants|||Number
813705|NCT01074931|Primary|Evolution of CD4 Count|The evolution of participants' CD4-positive (CD4+) T-lymphocyte counts after starting the lopinavir/ritonavir-containing regimen was to be assessed by measuring the number of CD4+ cells at baseline and each subsequent study visit. CD4+ count results are reported as the number of CD4+ cells per cubic millimeter (cmm). Study visits were to occur at approximately 3, 6, 12, and 18 months after starting treatment. The exact dates of each visit depended on the physician’s judgment, so data are reported for Visits 1 through 4 rather than by month.|Month 3, 6, 12, 18|Includes all participants taking at least one dose of lopinavir/ritonavir who had CD4+ count results at each particular time point.||cells per cmm||Standard Deviation|Mean
813706|NCT01074931|Primary|Evolution of the HIV Viral Response|The protocol recommended that HIV viral load tests be performed at baseline and each study visit. Test results indicate the number of HIV-1 ribonucleic acid (RNA) copies per milliliter (mL). The number of participants who underwent testing and had detectable levels (greater than 50 copies/mL) or undetectable levels (less than 50 copies/mL) are presented by subgroup. Study visits were to occur at approximately 3, 6, 12, and 18 months after starting treatment. The exact dates of each visit depended on the physician’s judgment, so data are reported for Visits 1 through 4 rather than by month.|Month 3, 6, 12, 18|All participants who took at least one dose of lopinavir/ritonavir and had HIV viral load testing.||participant|||Number
813707|NCT01074944|Secondary|LTTP: Mean Biomarker (MIP1-beta) Value at Baseline, 1 Year, and 2 Years|MIP1-beta biomarker was assayed from plasma.|Baseline, 1 year, and 2 years|All participants who received at least one dose of eliglustat during the LTTP.||pg/mL||Standard Deviation|Mean
813708|NCT01074944|Secondary|LTTP: Mean Biomarker (GL-1 on DBS) Value at Baseline, 1 Year, and 2 Years|GL-1 on DBS biomarker was assayed from dried blood spot.|Baseline, 1 year, and 2 years|All participants who received at least one dose of eliglustat during the LTTP.||mcg/mL||Standard Deviation|Mean
813709|NCT01074944|Secondary|LTTP: Mean Biomarker (Chitotriosidase) Value at Baseline, 1 Year, and 2 Years|Chitotriosidase biomarker was assayed from plasma.|Baseline, 1 year, and 2 years|All participants who received at least one dose of eliglustat during the LTTP.||nmol/hr/mL||Standard Deviation|Mean
813710|NCT01074944|Secondary|LTTP: Total Bone Marrow Burden Score (BMB) at Baseline, 1 Year, and 2 Years|BMB Score was measured using MRI, range from 0 (no abnormalities) to 8 points (severe disease) for the lumbar spine and from 0 (no abnormalities) to 8 points (severe disease) for the femurs. The total score was calculated as the sum of scores for femur and lumbar spine regions which ranged from 0 (no abnormalities) -16 (severe disease) points. A higher BMB score signified more severe bone marrow involvement.|Baseline, 1 year, and 2 years|All participants who received at least one dose of eliglustat during the LTTP.||BMB Score||Standard Deviation|Mean
813711|NCT01074944|Secondary|LTTP: Total Z-scores for BMD at Baseline, 1 Year, and 2 Years|Images of the spine and bilateral femur were obtained by DXA to determine Z-score for each bone area and total bone mineral density. The Z-score bone density categories are: normal (score >-2) and below normal (score <=-2).|Baseline, 1 year, and 2 years|All participants who received at least one dose of eliglustat during the LTTP.||Z-score||Standard Deviation|Mean
813712|NCT01074944|Secondary|LTTP: Total T-Scores for BMD at Baseline, 1 Year, and 2 Years|Images of the spine and bilateral femur were obtained by DXA to determine T-score for each bone area and total bone mineral density. The T-score bone density categories were: normal (score >-1), osteopenia (score -2.5 to <=-1), and osteoporosis (score <= -2.5).|Baseline, 1 year, and 2 years|All participants who received at least one dose of eliglustat during the LTTP.||T-score||Standard Deviation|Mean
813713|NCT01074944|Secondary|LTTP: Bone Mineral Density (BMD) at Baseline, 1 Year, and 2 Years|BMD measurements of the spine and bilateral femur were acquired by DXA scan.|Baseline, 1 year, and 2 years|All participants who received at least one dose of eliglustat during the LTTP.||g/cm^2||Standard Deviation|Mean
813714|NCT01074944|Secondary|LTTP: Number of Participants With Bone Pain Levels During the Past 4 Weeks at Baseline, 1 Year, and 2 Years|Bone pain was assessed as a part of Gaucher disease assessment in participants. Participants were categorized as none (no bone pain), very mild bone pain, mild bone pain, moderate bone pain, severe bone pain and extreme bone pain. In this outcome, number of participants with different level of bone pain during the past 4 weeks at specified time points were reported.|Baseline, 1 year and 2 years|All participants who received at least one dose of eliglustat during the LTTP.||participants|||Number
829232|NCT01225354|Secondary|Assessment of Malar Deficiency|Live subject malar deficiency severity will be rated by PI at Visits 1-4 according to the SOBER scale.|Visit 1-4||||||
813715|NCT01074944|Secondary|LTTP: Number of Participants With Bone Crises Assessment at Baseline, 1 Year and 2 Years|Bone crises was assessed as a part of Gaucher disease assessment in participants. Acute, excruciating episodic bone pain is characteristic of Gaucher bone crises, which typically causes debilitation lasting several days or longer and requires treatment with immobilization, hydration, and opioid analgesics. Participants were categorized as 0= no bone crises, 1= 1 bone crisis during the assessment period. In this outcome, number of participants with different bone crises levels at specified time points were reported.|Baseline, 1 year and 2 years|All participants who received at least one dose of eliglustat during the LTTP.||participants|||Number
813716|NCT01074944|Secondary|LTTP: Number of Participants With Mobility Status (MS) at Baseline, 1 Year and 2 Years|Mobility, i.e., ability to walk was assessed as a part of Gaucher disease assessment in participants. In this outcome, number of participants with their different mobility status along with the use of mobility aids (unrestricted mobility, walks with difficulty, walks with orthopaedic aid, requires wheelchair, bedridden) at specified time points were reported.|Baseline, 1 year, and 2 years|All participants who received at least one dose of eliglustat during the LTTP.||participants|||Number
813717|NCT01074944|Secondary|LTTP: Percentage of Participants Who Maintained a Stable Bone Criterion ,Hemoglobin Level, Platelet Count, Liver Volume and Spleen Volume at 1 Year and 2 Years|Participant were considered as stable if they met the following criteria: hemoglobin level did not decrease >1.5 g/dL from baseline for PAP, platelet count does not decrease >25% below Baseline for PAP, liver volume does not increase >20% above Baseline for PAP, spleen volume does not increase >25% above Baseline for PAP. Baseline for PAP was defined as last available assessment prior to randomization.|1 Year, 2 Years|Analysis was performed on intent to treat (ITT) population which included all participants who received at least 1 dose of eliglustat after randomization. Here ‘n’ signifies number of participants with available data at specified time points.||percentage of participants||95% Confidence Interval|Number
813718|NCT01074944|Secondary|LIP: Number of Participants With Bone Pain Levels During the Past 4 Weeks at Baseline, Weeks 26, 52 and 78|Bone pain was assessed as a part of Gaucher disease assessment in participants. Participants were categorized as none (no bone pain), very mild bone pain, mild bone pain, moderate bone pain, severe bone pain and extreme bone pain. In this outcome, number of participants with different type of bone pain during the past 4 weeks at specified time points were reported.|Baseline, Week 26, Week 52, Week 78|Analysis was performed on AT analysis set which included all participants who received at least 1 dose of eliglustat during LIP.||participants|||Number
813719|NCT01074944|Secondary|LIP: Number of Participants With Bone Crises Assessment at Baseline, Weeks 26, 52 and 78|Bone crises was assessed as a part of Gaucher disease assessment in participants. Acute, excruciating episodic bone pain is characteristic of Gaucher bone crises, which typically causes debilitation lasting several days or longer and requires treatment with immobilization, hydration, and opioid analgesics. Participants were categorized as 0= no bone crisis, 1= 1 bone crisis, 2= 2 bone crises, 6= 6 bone crises, and 24= 24 bone crises during the assessment period. In this outcome, number of participants with different bone crises levels at specified time points were reported.|Baseline, Week 26, Week 52, Week 78|Analysis was performed on AT analysis set which included all participants who received at least 1 dose of eliglustat during LIP.||participants|||Number
813720|NCT01074944|Secondary|LIP: Number of Participants With Mobility Status (MS) at Baseline, Weeks 26, 52 and 78|Mobility, i.e., ability to walk was assessed as a part of Gaucher disease assessment in participants. In this outcome, number of participants with their different mobility status along with the use of mobility aids (unrestricted mobility, walks with difficulty, walks with orthopaedic aid, requires wheelchair, bedridden) at specified time points were reported.|Baseline, Week 26, Week 52, Week 78|Analysis was performed on AT analysis set which included all participants who received at least 1 dose of eliglustat during LIP.||participants|||Number
813721|NCT01074944|Secondary|LIP: Mean Biomarker (MIP1-beta) Value at Baseline, Week 78|MIP1-beta biomarker was assayed from plasma.|Baseline and Week 78|Analysis was performed on AT analysis set which included all participants who received at least 1 dose of eliglustat during LIP. Here ‘n’ signifies number of participants with available data at specified time points.||pg/mL||Standard Deviation|Mean
813722|NCT01074944|Secondary|LIP: Mean Biomarker (GL-1 on DBS) Value at Baseline, Week 26, Week 52, and Week 78|GL-1 on DBS biomarker was assayed from dried blood spot.|Baseline, Week 26, Week 52 and Week 78|Analysis was performed on AT analysis set which included all participants who received at least 1 dose of eliglustat during LIP. Here ‘n’ signifies number of participants with available data at specified time points.||mcg/mL||Standard Deviation|Mean
813723|NCT01074944|Secondary|LIP: Mean Biomarker (Chitotriosidase) Value at Baseline, Weeks 26, 52, and 78|Chitotriosidase biomarker was assayed from plasma.|Baseline, Week 26, Week 52 and Week 78|Analysis was performed on AT analysis set which included all participants who received at least 1 dose of eliglustat during LIP. Here ‘n’ signifies number of participants with available data at specified time points.||nmol/hr/mL||Standard Deviation|Mean
813724|NCT01074944|Secondary|LIP: Mean Spleen Volume at Baseline, Weeks 26, 52 and 78||Baseline, Week 26, Week 52, Week 78|Analysis was performed on AT participants which included all participants who received at least 1 dose of eliglustat during lead in period. Here 'n' signifies number of participants with available data at specified time points.||MN||Standard Deviation|Mean
813725|NCT01074944|Secondary|LIP: Mean Liver Volume at Baseline, Weeks 26, 52 and 78||Baseline, Week 26, Week 52, Week 78|Analysis was performed on AT participants which included all participants who received at least 1 dose of eliglustat during lead in period. Here, 'n' signifies number of participants with available data at specified time points.||MN||Standard Deviation|Mean
813726|NCT01074944|Secondary|LIP: Mean Platelet Count at Baseline, Weeks 26, 52 and 78||Baseline, Week 26, Week 52, Week 78|Analysis was performed on AT analysis set which included all participants who received at least 1 dose of eliglustat during LIP. Here ‘n’ signifies number of participants with available data at specified time points.||platelets*10^9 /L||Standard Deviation|Mean
813727|NCT01074944|Secondary|LIP: Mean Hemoglobin (Hb) Level at Baseline, Weeks 26, 52 and 78||Baseline, Week 26, Week, 52, and Week 78|Analysis was performed on all treated (AT) analysis set which included all participants who received at least 1 dose of eliglustat during lead in period. Here 'n' signifies number of participants with available data at specified time points.||g/dL||Standard Deviation|Mean
829622|NCT01227421|Secondary|Time Loss From Work|Time loss from work|28 days|Analysis conducted on 241 patients with laboratory confirmed influenza excluding those who are unemployed||days||95% Confidence Interval|Mean
813728|NCT01074944|Secondary|PAP: Total Bone Marrow Burden Score (BMB) at Baseline and Week 52|BMB Score was measured using magnetic resonance imaging (MRI), range from 0 (no abnormalities) to 8 points (severe disease) for the lumbar spine and from 0 (no abnormalities) to 8 points (severe disease) for the femurs. The total score was calculated as the sum of scores for femur and lumbar spine regions which ranged from 0 (no abnormalities) -16 (severe disease) points. A higher BMB score signified more severe bone marrow involvement.|Baseline, Week 52|PP population included all participants who were at least 80% compliant with IMP dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations. Here, 'n' signifies number of participants with available data at specified time points for each arm respectively.||BMB Score||Standard Deviation|Mean
813729|NCT01074944|Secondary|PAP: Number of Participants With Bone Pain Levels During the Past 4 Weeks at Baseline, Weeks 26 and 52|Bone pain was assessed as a part of Gaucher disease assessment in participants. Participants were categorized as none (no bone pain), very mild bone pain, mild bone pain, moderate bone pain, severe bone pain and extreme bone pain during the past 4 weeks. In this outcome, number of participants with different level of bone pain during the past 4 weeks at specified time points were reported.|Baseline, Week 26, and Week 52|PP population included all participants who were at least 80% compliant with IMP dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations.||participants|||Number
813730|NCT01074944|Secondary|PAP: Number of Participants With Bone Crises at Baseline, Weeks 26 and 52|Bone crisis was assessed as a part of Gaucher disease assessment in participants. Acute, excruciating episodic bone pain is characteristic of Gaucher bone crisis, which typically causes debilitation lasting several days or longer and requires treatment with immobilization, hydration, and opioid analgesics. Participants were categorized as 0= no bone crisis, 1= 1 bone crisis, and 2= 2 bone crises during the assessment period. In this outcome, number of participants with different bone crises levels at specified time points were reported.|Baseline, Week 26, and Week 52|PP population included all participants who were at least 80% compliant with IMP dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations.||participants|||Number
813731|NCT01074944|Secondary|PAP: Number of Participants With Mobility Status Asessments (MS) at Baseline, Weeks 26, and 52.|Mobility, i.e., ability to walk was assessed as a part of Gaucher disease assessment in participants. In this outcome, number of participants with their different mobility status along with the use of mobility aids (unrestricted mobility, walks with difficulty, walks with orthopaedic aid, requires wheelchair, bedridden) at specified time points were reported.|Baseline, Week 26 and Week 52|PP population included all participants who were at least 80% compliant with IMP dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations.||participants|||Number
813732|NCT01074944|Secondary|PAP: Total Z-scores for BMD at Baseline and Week 52|Images of the spine and bilateral femur were obtained by DXA to determine Z-score for each bone area and total bone mineral density. The Z-score bone density categories are: normal (score >-2) and below normal (score <=-2).|Baseline, Week 52|PP population included all participants who were at least 80% compliant with IMP dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations. Here 'n' signifies number of participants with available data for specified category for each arm respectively||Z-score||Standard Deviation|Mean
813733|NCT01074944|Secondary|PAP: Total T-Scores for BMD at Baseline and Week 52|Images of the spine and bilateral femur were obtained by DXA to determine T-score for each bone area and total bone mineral density. The T-score bone density categories were: normal (score >-1), osteopenia (score -2.5 to <=-1), and osteoporosis (score <= -2.5).|Baseline, Week 52|PP population included all participants who were at least 80% compliant with IMP dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations. Here 'n' signifies number of participants with available data at specified time points for each arm respectively.||T-score||Standard Deviation|Mean
813734|NCT01074944|Secondary|PAP: Bone Mineral Density (BMD) at Baseline and Week 52|BMD measurements of the spine and bilateral femur were acquired by dual-energy x-ray absorptiometry (DXA) scan.|Baseline, Week 52|PP population included all participants who were at least 80% compliant with IMP dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations. Here, 'n' signifies number of participants with available data at specified time points for each arm respectively.||g/cm^2||Standard Deviation|Mean
813735|NCT01074944|Secondary|PAP: Mean Biomarker Macrophage Inflammatory Protein-1 Beta (MIP1-beta) Value at Baseline, Weeks 26, 52|MIP1-beta biomarker was assayed from plasma.|Baseline, Week 26, Week 52|PP population included all participants who were at least 80% compliant with dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations. Here, 'n' signifies number of participants with available data for specified category for each arm respectively.||pg/mL||Standard Deviation|Mean
813736|NCT01074944|Secondary|PAP: Mean Biomarker (GL-1 on DBS) Value at Baseline, Week 26 and Week 52|GL-1 on DBS biomarker was assayed from dried blood spot (DBS).|Baseline, Week 26 and week 52|PP population included all participants who were at least 80% compliant with IMP dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations. Here 'n' signifies number of participants with available data at specified time points for each arm respectively.||mcg/mL||Standard Deviation|Mean
813737|NCT01074944|Secondary|PAP: Mean Biomarker (Chitotriosidase) Value at Baseline, Weeks 26 and Week 52|Chitotriosidase biomarker was assayed from plasma.|Baseline, Week 26, Week 52|PP population which all participants who were at least 80% compliant with IMP dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations. Here, 'n' signifies number of participants with available data for specified category for each arm respectively.||nmol/hr/mL||Standard Deviation|Mean
813738|NCT01074944|Secondary|PAP: Mean Liver Volume at Baseline, Weeks 26, 52||Baseline, Week 26 and Week 52|PP population included all participants who were at least 80% compliant with IMP dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations.||MN||Standard Deviation|Mean
813740|NCT01074944|Secondary|PAP: Mean Platelet Count at Baseline, Weeks 26, 52||Baseline, Week 26, Week 52|PP population included all participants who were at least 80% compliant with IMP dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations. Here 'n' signifies number of participants with available data at specified time points for each arm respectively.||platelets*10^9 /L||Standard Deviation|Mean
813741|NCT01074944|Secondary|PAP: Mean Hemoglobin (Hb) Level at Baseline, Weeks 26 and 52||Baseline, Week 26, Week 52|PP population included all participants who were at least 80% compliant with IMP dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations. Here 'n' signifies number of participants with available data at specified time points for each arm respectively.||g/dL||Standard Deviation|Mean
813742|NCT01074944|Primary|PAP: Percentage of Participants Who Remained Stable for 52 Weeks During the PAP|Participants were considered as stable if they met all of the following criteria: 1) no more than 2 bone crisis during PAP (with no more than 1 bone crisis during either the first 6 months or the later 6 months of the period), and were free of other clinically symptomatic bone disease during the entire 52-week PAP; 2) hemoglobin level not decreased >1.5 g/dL from Baseline for PAP; 3) platelet count not decreased >25% from Baseline for PAP; 4) spleen volume (in multiples of normal [MN]) did not increase >25% from Baseline for PAP; 5) liver volume (in MN) did not increase >20% from Baseline for PAP. Baseline for PAP was defined as the last assessment prior to randomization.|PAP Baseline up to the end of PAP (Week 52)|Analysis was performed on per protocol (PP) population which included all participants who were at least 80% compliant with investigational medicinal product (IMP) dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations.||percentage of participants||95% Confidence Interval|Number
813743|NCT01081041|Secondary|Area Under the Concentration Curve (AUC) of Cetuximab at Steady State|A total of 4 samples were collected during combination therapy, from the first dose of 250 mg/m^2 cetuximab in Cycle 1 (Day 1) through the final dose in Cycle 3 (Week 3) and used to report AUC of cetuximab at steady state during Part 2 of the study. As specified in the protocol, PK samples were not collected during Part 1 of the study, Safety Lead-In, or during Part 2 monotherapy.|Part 2: Weekly from Cycle 1, Day 1 through Cycle 3, Week 3: 0 h (immediately postdose), 24 h, 96 h, and 168 h postdose|Participants who received at least 1 dose of cetuximab (250 mg/m^2) and had valid serum cetuximab concentrations during the specified time frame. No participant was analyzed during Part 1 of the study, Safety Lead-In, or during Part 2 monotherapy.||micrograms*hours/milliliter (μg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
813744|NCT01081041|Secondary|Cmax of Cetuximab at Steady State|A total of 4 samples were collected at various times during combination therapy, from the third dose of 250 mg/m^2 cetuximab in Cycle 1 (Week 3) through the final dose in Cycle 3 (Week 3) and used to report Cmax of cetuximab at steady state during Part 2 of the study. As specified in the protocol, PK samples were not collected during Part 1 of the study, Safety Lead-In, or during Part 2 monotherapy.|Part 2: Weekly from Cycle 1, Week 3 through Cycle 3, Week 3: 0 h (immediately postdose), 24 h, 96 h, and 168 h postdose|Participants who received at least 1 dose of cetuximab (400 mg/m^2) and had valid serum cetuximab concentrations during the specified time frame. No participant was analyzed during Part 1 of the study, Safety Lead-In, or during Part 2 monotherapy.||micrograms per milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
813745|NCT01081041|Secondary|Maximum Serum Concentration (Cmax) of Cetuximab Following 400 mg/m² Cetuximab Dosing|The Cmax of cetuximab following 400 mg/m² cetuximab dosing during Part 2 of the study is reported. As specified in the protocol, pharmacokinetics (PK) samples were not collected during Part 1 of the study, Safety Lead-In or during Part 2 monotherapy.|Part 2: Cycle 1, Day 1: 0 hours [(h); immediately postdose], 1 h, 2 h, and 24 h postdose|Participants who received at least 1 dose of cetuximab (400 mg/m²) and had valid serum cetuximab concentrations during the specified time frame. No participant was analyzed during Part 1 of the study, Safety Lead-In or during Part 2 monotherapy..||micrograms per milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
813746|NCT01081041|Secondary|Percentage of Participants Having a Best Response of CR, PR, or Stable Disease (SD) - Disease Control Rate (DCR)|Response was defined using RECIST, v1.0 criteria. CR was defined as the disappearance of all target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions. Progressive Disease (PD) was defined as having at least a 20% increase in the sum of the longest diameter of target lesions. Stable Disease (SD) was defined as small changes that did not meet the above criteria.|Parts 1 and 2: Randomization to Progression of Disease (Up to 32.7 Months)|All participants who received at least one dose of study drug.||percentage of participants||95% Confidence Interval|Number
813747|NCT01081041|Secondary|Number of Participants With Anti-Cetuximab Antibodies||Day 1, Week 1 of Cycles 3 and 5 (postbaseline samples were collected prior to infusion).|Participants who received at least 1 dose of study drug and had evaluable data for antibodies.There was no pre-specified analysis plan for trial to report immunogenicity results separately for each arm,as results were intended to be pooled and combined with other cetuximab trials data.Data was pooled for the three arms for cetuximab in this trial.||participants|||Number
813748|NCT01081041|Secondary|Percentage of Participants Having a Confirmed Best Response of Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])|Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version [v]1.0) criteria. CR was defined as the disappearance of all target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions. Percentage of participants with a confirmed CR or PR=(number of participants whose best overall response was CR or PR)/(number of participants treated)*100.|Parts 1 and 2: Randomization to Progression of Disease (Up to 32.7 Months)|All participants who received at least one dose of study drug.||percentage of participants||95% Confidence Interval|Number
813758|NCT01081132|Secondary|Percent of Subjects With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores at the Last On-Treatment Assessment|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|weeks 1 through 13|Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.||percentage of subjects|||Number
814965|NCT01092663|Secondary|Fasting Plasma Total Glucose-dependent Insulinotropic Peptide (GIP)|To evaluate the effect of treatments on plasma Glucose-dependent Insulinotropic Peptide (GIP) concentrations.|Baseline and 12 weeks|||pmol/L||Standard Deviation|Mean
813749|NCT01081041|Secondary|Progression-Free Survival (PFS)|PFS was defined as duration from the date of randomization to the first date of objective progressive disease (PD) or death from any cause. For each participant who was not known to have died or to have had objective PD as of the 23 October 2014 data cutoff date for the analysis, PFS was censored at the date of the participant’s last complete tumor assessment prior to that cutoff date. In addition, any participant in Arm B who was switched from BI-manufactured cetuximab to ImClone-manufactured cetuximab was censored at the time of the switch.|Parts 1 and 2: Randomization to Progression of Disease or Death from any Cause (Up to 32.7 Months)|All participants who received at least one dose of study drug. 7 participants were censored in Safety Lead-In ,12 participants were censored in Cetuximab (US Commercial) and 15 in Cetuximab (Manufactured by BI).||Months||95% Confidence Interval|Median
813750|NCT01081041|Secondary|Overall Survival (OS)|OS was defined as duration from the date of randomization to the date of death from any cause. For each participant not known to have died as of the 23 October 2014 data cutoff date for the analysis, OS was censored at the date last known to be alive. In addition, any participants on Arm B who was switched from BI-manufactured cetuximab to ImClone-manufactured cetuximab was censored at the time of the switch.|Parts 1 and 2: Randomization to Date of Death from any Cause (Up to 36.3 Months)|All participants who received at least on dose of study drug. 4 participants were censored in Safety Lead-In, 17 participants were censored in Cetuximab (US Commercial) and 15 in Cetuximab (Manufactured by BI).||Months||95% Confidence Interval|Median
813751|NCT01081041|Primary|Number of Participants Who Had TEAEs; Data Analysis Cut-Off: January 23, 2013|January 23, 2013 is the date when the first participant in the BI-manufactured cetuximab treatment arm switched to US commercial cetuximab due to changes in the manufacturing process for the BI-manufactured cetuximab necessitating the need to switch participants to US commercial cetuximab. Each participant who switched treatments received at least 2 cycles of BI-manufactured cetuximab before switching. All other components of their treatment regimen remained unchanged. The number of participants who had TEAEs during combination therapy is reported. Using January 23 cut-off, data is un-confounded by lack of BI-manufactured cetuximab. TEAEs were defined as serious and other non-serious adverse events (AEs) that occurred or worsened after study treatment (regardless of causality). TEAE information for Safety Lead-in group available in Reported Adverse Event module which is summary of serious and other non-serious AEs regardless of causality.|Part 2: Baseline to end of combination therapy or date first participant switched to US commercial cetuximab (up to 18 weeks)|Participants who received at least 1 dose of study drug (cetuximab, cisplatin, carboplatin, or 5-FU) according to the treatment arm to which they were assigned or randomized.||participants|||Number
813752|NCT01081041|Primary|Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs); Data Analysis Cut-Off: September 27, 2013|September 27, 2013 is the date when data was last collected for the primary endpoint. Prior to this date, the manufacturing process for the BI-manufactured cetuximab was changed necessitating the need to switch participants to US commercial cetuximab. All other components of their treatment regimen remained unchanged and participants stayed in their original reporting group. Therefore, the number of participants in the BI-manufactured cetuximab treatment arm who had TEAEs includes TEAEs while participants received BI-manufactured and US-commercial cetuximab. Using September 27 cut-off, the analysis of TEAEs is confounded by the switch from BI-manufactured to US commercial cetuximab. TEAEs were defined as serious and other non-serious AEs that occurred or worsened after study treatment (regardless of causality). TEAE information for Safety Lead-In group available in Reported Adverse Events module which is summary of serious and other non-serious AEs regardless of causality.|Part 2: Baseline to end of combination therapy (up to 18 weeks)|Participants who received at least 1 dose of study drug (cetuximab, cisplatin, carboplatin, or 5-FU) according to the treatment arm to which they were assigned or randomized. Data is confounded for 9 participants in BI-manufactured cetuximab treatment arm who switched to US commercial cetuximab.||participants|||Number
813753|NCT01081132|Secondary|Columbia-Suicide Severity Rating Scale (C-SSRS)|C-SSRS is a semi-structured interview that captures the occurence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale.|Through week 16|Safety Population consisted of all randomized subjects who took at least 1 dose of investigational product.||participants|||Number
813754|NCT01081132|Secondary|Structure Side-Effect Questionnaire (SSEQ)|The Structured Side-effect Questionnaire is a simple checklist of 17 side effects. The subject indicates whether a side effect has occurred since the last visit by marking ‘yes’ or ‘no’ on the checklist for each of the events listed.|Through week 16|Safety Population consisted of all randomized subjects who took at least 1 dose of investigational product.||participants|||Number
813755|NCT01081132|Secondary|Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRS-C) Total Score at Last On-Treatment Assessment|The BPRS-C characterizes childhood behavioral and emotional symptomatology. A total of 21 items are rated on a scale from 0 (not present) to 6 (extremely severe) with a total score ranging from 0 to 126. A decrease in score indicates a reduction in psychopathology.|Baseline and week 13|Safety Population consisted of all randomized subjects who took at least 1 dose of investigational product.||units on a scale||Standard Deviation|Mean
813756|NCT01081132|Secondary|Change From Baseline in Pediatric Daytime Sleepiness Scale (PDSS) Total Score at Week 13|The Pediatric Daytime Sleepiness Scale (PDSS) is an 8 item questionnaire scored on a scale from 0 (never) to 4 (always/very often). Total scores range from 0 to 32, with increasing score reflecting greater sleepiness.|Baseline through week 13|Safety Population consisted of all randomized subjects who took at least 1 dose of investigational product.||units on a scale||Standard Error|Least Squares Mean
813757|NCT01081132|Secondary|Changes From Baseline in Behavior Rating Inventory of Executive Function (BRIEF) Scores at Week 13|Behavior Rating Inventory of Executive Function (BRIEF) is a questionnaire composed of three indices: Global Executive Composite, Behavioral Regulation Index, and Metacognition Index. Items are rated 1 (never), 2 (sometimes), and 3 (often). The Global Executive Composite consists of 72 items with scoring ranging from 72 to 216. The Behavioral Regulation Index score is the total of 28 items and ranges from 28 to 84. The Metacognition Index score is the total of 44 items and ranges from 44 to 132. Lower scores reflect better functioning.|Baseline and week 13|Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.||units on a scale||Standard Error|Least Squares Mean
813759|NCT01081132|Secondary|Change From Baseline in the WFIRS-P Academic Performance Domain Score at Week 13|The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.|Baseline and week 13|Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.||units on a scale||Standard Error|Least Squares Mean
813760|NCT01081132|Secondary|Change From Baseline in the WFIRS-P Life Skills Domain Score at Week 13|The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). The Life Skills Domain consists of 10-items. Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.|Baseline and week 13|Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.||units on a scale||Standard Error|Least Squares Mean
813761|NCT01081132|Secondary|Change From Baseline in the WFIRS-P Child Self-Concept Domain Score at Week 13|The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). The Child Self-Concept Domain consists of 3-items. Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.|Baseline and week 13|Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.||units on a scale||Standard Error|Least Squares Mean
813762|NCT01081132|Secondary|Change From Baseline in the WFIRS-P Social Domain Score at Week 13|The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). The Social Domain consists of 7-items. Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.|Baseline and week 13|Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.||units on a scale||Standard Error|Least Squares Mean
813763|NCT01081132|Secondary|Change From Baseline in the WFIRS-P Risk Domain Score at Week 13|The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). The Risk Domain consists of 10-items. Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.|Baseline and week 13|Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.||units on a scale||Standard Error|Least Squares Mean
813764|NCT01081132|Secondary|Change From Baseline in the WFIRS-P Global Domain Score at Week 13|The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.|Baseline and week 13|Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.||units on a scale||Standard Error|Least Squares Mean
813765|NCT01081132|Secondary|Change From Baseline in the WFIRS-P Behavior in School Domain Score at Week 13|The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.|Baseline and week 13|Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.||units on a scale||Standard Error|Least Squares Mean
813766|NCT01081132|Secondary|Change From Baseline in the WFIRS-P Family Domain Score at Week 13|The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). The Family Domain consists of 10-items. Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.|Baseline and week 13|Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.||units on a scale||Standard Error|Least Squares Mean
813767|NCT01081132|Secondary|Change From Baseline in the Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Learning and School Domain Scores at Week 13|The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). The Learning and School Domain consists of 10-items. Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.|Baseline and week 13|Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.||units on a scale||Standard Error|Least Squares Mean
813768|NCT01081132|Secondary|Percent of Subjects With an Assessment of Normal/Borderline Mentally Ill on Clinical Global Impression-Severity of Illness (CGI-S) Scale at the Last On-Treatment Assessment|CGI-S assesses the severity of the subject's condition on a 7-point scale: 1 (normal, not at all ill), 2 (borderline mentally ill), 3 (mildly ill), 4 (moderately ill), 5 (markedly ill), 6 (severely ill), 7 (among the most extremely ill)|Baseline through week 13|Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.||percentage of subjects|||Number
813769|NCT01081132|Primary|Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Week 13|The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|Baseline through week 13|The Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product. A mixed model repeated measures (MMRM) was used to analyze the observed change from the Baseline Visit scores at all post-baseline, pre-taper, on-treatment visits.||units on a scale||Standard Error|Least Squares Mean
813770|NCT01081145|Secondary|Columbia-Suicide Severity Rating Scale During Open-Label Phase|C-SSRS is a semi-structured interview that captures the occurence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale.|13 weeks|Open-label Safety Population defined as all subjects who took at least 1 dose of any investigational product during the study.||participants|||Number
813771|NCT01081145|Secondary|HUI 2/3 Scores During the Open-Label Phase - LOCF|HUI is used to describe health status and to obtain utility scores by collecting data using one or more questionnaires in formats selected to match the specific study design criteria. Scoring ranges from 0.00 (dead) to 1.00 (perfect health). Higher scores represent better health status.|13 weeks|Open-label FAS||units on a scale||Standard Deviation|Mean
813772|NCT01081145|Secondary|Change From Open-Label Baseline in WFIRS-P Global Score at Week 13 of the Open-Label Phase - LOCF|The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.|Baseline and week 13|Open-label FAS||units on a scale||Standard Deviation|Mean
814966|NCT01092663|Secondary|Fasting Active Plasma Glucagon Like-Peptide 1 (GLP-1)|To evaluate the effect of treatments on plasma GLP-1 concentrations.|Baseline and 12 weeks|||pmol/L||Standard Deviation|Mean
813774|NCT01081145|Secondary|Percent of Subjects With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores During Open-Label Phase - LOCF|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|13 weeks|Open-label FAS||percentage of participants|||Number
813775|NCT01081145|Secondary|Percentage of Responders in the Open-Label Phase - LOCF|Response is defined as a percentage decrease (improvement) from Baseline in the ADHD-RS-IV total score of >=30% and a CGI-S score of 1 or 2.|13 weeks|Open-label FAS||percentage of participants|||Number
813776|NCT01081145|Secondary|Change From Open-Label Baseline in ADHD-RS-IV Total Score at Week 13 of the Open-Label Phase - LOCF|The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|Baseline and 13 weeks|Open-label Full Analysis Set (FAS) defined as all subjects who took at least 1 dose of any investigational product during the study. The Subjects from Site 801 were excluded from the Open-label FAS.||units on a scale||Standard Deviation|Mean
813777|NCT01081145|Secondary|Columbia-Suicide Severity Rating Scale During Double-Blind Randomized-Withdrawal Phase|C-SSRS is a semi-structured interview that captures the occurence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale.|26 weeks|Randomized Safety Population defined as all subjects who were randomized and who took at least 1 dose of investigational product during the Double-blind Randomized-withdrawal Phase.||participants|||Number
813778|NCT01081145|Secondary|Health Utilities Index-2/3 (HUI 2/3) Scores During the Double-Blind Randomized-Withdrawal Phase - LOCF|HUI is used to describe health status and to obtain utility scores by collecting data using one or more questionnaires in formats selected to match the specific study design criteria. Scoring ranges from 0.00 (dead) to 1.00 (perfect health). Higher scores represent better health status.|26 weeks|Randomized FAS||units on a scale||Standard Deviation|Mean
813779|NCT01081145|Secondary|Change From Double-Blind Randomized-Withdrawal Baseline in the Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at Week 26 of the Double-Blind Randomized-Withdrawal Phase - LOCF|The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.|Baseline and week 26|Randomized FAS||units on a scale||Standard Error|Least Squares Mean
813780|NCT01081145|Secondary|Percent of Subjects With an Assessment of Normal/Borderline Mentally Ill on Clinical Global Impression-Severity of Illness (CGI-S) Scale During the Double-Blind Randomized-Withdrawal Phase - LOCF|CGI-S assesses the severity of the subject's condition on a 7-point scale: 1 (normal, not at all ill), 2 (borderline mentally ill), 3 (mildly ill), 4 (moderately ill), 5 (markedly ill), 6 (severely ill), 7 (among the most extremely ill)|26 weeks|Randomized FAS||percentage of subjects|||Number
813781|NCT01081145|Secondary|Change From Double-Blind Randomized-Withdrawal Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Week 26 of the Double-Blind Randomized-Withdrawal Phase - Last Observation Carried Forward (LOCF)|The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|Baseline and week 26|Randomized FAS||units on a scale||Standard Error|Least Squares Mean
813782|NCT01081145|Secondary|Time to Treatment Failure During the Double-Blind Randomized-Withdrawal Phase|Treatment failure was defined as >= 50% increase (worsening) in ADHD-RS-IV total score and a >= 2 point increase (worsening) in CGI-S score compared with the respective scores at the Double-blind Randomized-withdrawal Baseline Visit at 2 consecutive Double-blind Randomized-withdrawal Phase visits. Subjects meeting these criteria were regarded as treatment failures regardless of whether or not they were withdrawn. All subjects who discontinued the study for any reason were regarded as treatment failures for the primary analysis.|26 weeks|Randomized FAS||Days||95% Confidence Interval|Median
813783|NCT01081145|Primary|Percentage of Participants With Treatment Failures During the Double-Blind Randomized-Withdrawal Phase|Treatment failure was defined as >= 50% increase (worsening) in ADHD-RS-IV total score and a >= 2 point increase (worsening) in CGI-S score compared with the respective scores at the Double-blind Randomized-withdrawal Baseline Visit at 2 consecutive Double-blind Randomized-withdrawal Phase visits. Subjects meeting these criteria were regarded as treatment failures regardless of whether or not they were withdrawn. All subjects who discontinued the study for any reason were regarded as treatment failures for the primary analysis.|26 weeks|Randomized Full Analysis Set (FAS) defined as all subjects who were randomized and took at least 1 dose of investigational product during the Double-blind Randomized-withdrawal Phase. Subjects from Site 801 were excluded from the Randomized FAS.||percentage of treatment failures||95% Confidence Interval|Number
813784|NCT01081249|Secondary|Subjective Ratings of Anxiety and Trust of the Therapist|Patient will fill out ratings of subjective anxiety (STAI), mood and energy (PANAS), and trust (Likert scale) in the therapist before and after the session.|measured before drug, immediately before session, and after the session||||||
813785|NCT01081249|Secondary|Heart Rate Variability (HRV)|HRV will be measured before, during and after the therapy session.|continuously monitored from time before drug delivery to 20 minutes after session||||||
813786|NCT01081249|Secondary|Salivary Cortisol|Salivary cortisol will be measured after the treatment, and before, during and after the therapy session.|before drug, before session, and 20 minutes after session||||||
813787|NCT01081249|Primary|Verbal and Nonverbal Behavior in Therapy Session: Effects of Drug|Videotapes of 2 therapy session (PBO/OT) were reviewed by blinded raters to determine differences in two treatments. There were nine aspects analyzed using the Ethological Coding System for Interviews: eye contact, affiliation, submission, prosocial, flight, assertion, displacement, relaxation, and gesture.|videotapes of session were reviewed and scored 1-3 months after the patient completes the study|||Number of behaviors exhibited||Standard Deviation|Mean
813802|NCT01081873|Secondary|Epidemiological Data: Mean Age|The mean age of all participants at baseline is provided.|at time 0 (Baseline)|Analysis was performed on the full analysis set consisting of all patients for whom at least baseline data were recorded. Data for age was available for 2,691 patients and for weight for 2,116 patients.||years||Standard Deviation|Mean
813788|NCT01081301|Secondary|SF12: Physical Health|The SF12 was developed to be a shorter yet valid alternative to the SF 36 as a measure of quality of life. The SF12 measures 7 concepts: Physical functioning, role limitations due to physical health problems, bodily pain, general healthy vitality, social functioning, role limitations due to emotional problems and mental health. It produces a physical component summary score (PCS), and a mental health component summary score (MCS). Scores range from 0 (poor health) to 100 (perfect health).|Baseline, 1week, 2 weeks, 3, 6 and 12 months|||units on a scale||Standard Deviation|Mean
813789|NCT01081301|Secondary|Non-Death Revised Grief Experience Inventory|The Non-Death Revised Grief Experience Inventory measures grief that is not associated with the death of a person. It is a 22-item scale measuring four domains (existential concerns, depression, tension and guilt, and physical distress) of the grief experience. Responses are scored on a 6-point scale, ranging from slight disagreement to strong agreement, with higher total score indicating more grief and loss. The Non-Death Revised Grief Experience Inventory has a minimum score of 22 and a maximum score of 132.|Baseline, 1week, 2 weeks, 3, 6 and 12 months|||units on a scale||Standard Deviation|Mean
813790|NCT01081301|Secondary|General Self-Efficacy Score (GSES)|The scale consists of 10 items with responses from 1-4. The higher the Scores on the General Self Efficacy Scale (which has a range from 10 - 40), indicate higher participant feelings of self-efficacy. The General Self Efficacy Scale was chosen as a measure for this study because it has been found to be a reliable and valid measure in many populations.|Baseline, 1week, 2 weeks, 3, 6 and 12 months|||units on a scale||Standard Deviation|Mean
813791|NCT01081301|Secondary|SF12 Mental Health|The SF12 was developed to be a shorter yet valid alternative to the SF 36 as a measure of quality of life. The SF12 measures 7 concepts: Physical functioning, role limitations due to physical health problems, bodily pain, general healthy vitality, social functioning, role limitations due to emotional problems and mental health. It produces a physical component summary score (PCS), and a mental health component summary score (MCS). Scores range from 0 (poor health) to 100 (perfect health).|baseline, 1 and 2 wks, 3, 6 and 12 months|||units on a scale||Standard Deviation|Mean
813792|NCT01081301|Primary|Herth Hope Index|The Herth Hope Index is a 12 item (1-4 point) Likert scale that delineates three sub-scales of hope: a) temporality and future, b) positive readiness and expectancy, and c) interconnectedness. These three subscales are consistent with descriptions of hope by caregivers in the preliminary work completed by the research team. The subscales also include measures of relationships and spirituality that are considered factors that influence hope. Summative scores range from 12-48, with a higher score denoting greater hope.|Baseline, 1week, 2 weeks, 3, 6 and 12 months|||units on a scale||Standard Deviation|Mean
813793|NCT01081873|Secondary|Epidemiological Data: Metastasis Staging (M0 or M1) at Baseline|The number of participants at baseline reported to be in metastasis stage M0 or M1 is summarized. M0: no distant metastasis. M1: metastasis to distant organs beyond regional lymph nodes.|at time 0 (Baseline)|Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data.||participants|||Number
813794|NCT01081873|Secondary|Epidemiological Data: Bone Scan at Baseline|The number of participants at baseline with a positive or negative bone scan was summarized. Determination of bone scan status was based on the interpretation of the Investigator or radiologist.|at time 0 (Baseline)|Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data.||participants|||Number
813795|NCT01081873|Secondary|Epidemiological Data: Node Staging - the Number of Participants With a N0 or N1 Stage at Baseline.|N0: tumor cells absent from regional lymph nodes. N1: regional lymph node metastasis present.|at time 0 (Baseline)|Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data.||participants|||Number
813796|NCT01081873|Secondary|Epidemiological Data: Node Staging - the Number of Participants With a Positive or Negative Computerized Tomography (CT) Scan or Magnetic Resonance Imaging (MRI) Test|In this case, a CT or MRI is considered positive when lymph nodes are detectable. A CT or MRI is considered negative when lymph nodes are not detectable.|at time 0 (Baseline)|Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data.||participants|||Number
813797|NCT01081873|Secondary|Epidemiological Data: the Number of Participants With Tumor Stages T0, T1, T2, T3, and T4.|The number of participants with tumor stages T0, T1, T2, T3, and T4 as reported by the physician or pathologist is summarized. T0: no evidence of primary tumor. T1: histologic tumor confined to prostate; clinically unapparent tumor, undetectable by digital rectal examination or by ultrasound. T2: tumor is confined to prostrate and can be detected by digital rectal examination. T3: tumor extends through the prostate capsule but has not spread to other organs. T4: tumor has invaded adjacent structures/organs other than seminal vesicles.|at time 0 (Baseline)|Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data.||participants|||Number
813798|NCT01081873|Secondary|Epidemiological Data: Tumor Staging (Positive or Negative) Via a Rectal Examination, Prostate Biopsy, Echograph, or Magnetic Resonance Imaging (MRI) Test.|The number of participants at baseline who were positive or negative for tumors via a rectal examination, prostate biopsy, echograph of the hyperechogenic zones, or MRI are provided.|at time 0 (Baseline)|Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data.||participants|||Number
813799|NCT01081873|Secondary|Epidemiological Data: PSA at Baseline|The median, minimum, and maximum PSA values in ng/mL at baseline are provided. The mean PSA at baseline is reported in the Primary Outcome Measure section above.|at time 0 (Baseline)|Analysis was performed on the full analysis set consisting of all patients for whom at least baseline data were recorded. Data for PSA at baseline was available for 2,532 patients.||ng/mL||Full Range|Median
813800|NCT01081873|Secondary|Epidemiological Data: Tumor Staging - Among Participants With a Positive Biopsy, the Number of Participants With Adenocarcinoma Tissue or Other Tissues Recorded for the Positive Biopsy.|Among those participants with a positive biopsy at baseline, the number of participants with adenocarcinoma tissue or other tissue type is summarized.|at time 0 (Baseline)|Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data.||participants|||Number
813801|NCT01081873|Secondary|Epidemiological Data: Race|The number of participants by race at baseline is presented.|at time 0 (Baseline)|Analysis was performed on the full analysis set consisting of all patients for whom at least baseline data were recorded. Data for race was available for 2,217 patients.||participants|||Number
813804|NCT01081873|Secondary|Safety Parameter: Number of Participants Reporting Serious Adverse Events (SAEs)|The number of participants experiencing a serious adverse event during the course of the study is summarized. See the Reported Adverse Event section for details.|Baseline to disease progression or 24 months, whichever came first|Analysis was performed on the full analysis set consisting of all patients for whom at least baseline data were recorded.||participants|||Number
813805|NCT01081873|Primary|Treatment Patterns for Prostate Cancer Treatments: Number of Participants at Each Visit Who Took Lucrin/Lucrin Tridepot, Luteinizing Hormone-releasing Hormone (LHRH) Agonists, Anti-androgens, or Other Drug Treatments, or Who Had Surgery or Radiotherapy.|Prostate cancer treatment for all participants is summarized by the number of participants at each visit who took any Lucrin/Lucrin Tridepot, LHRH agonist, anti-androgens, or other drug treatments, or who had any type of surgery or radiotherapy (external radiation or brachytherapy).|time 0 (Baseline), month 3, and every 3 months until disease progression or up to 24 months, whichever came first|Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data at each visit.||participants|||Number
813806|NCT01081873|Primary|Effectiveness Parameter for Prognosis: the Number of Participants With a Survival Prognosis of > 10 Years, 5 - 10 Years, 1 - 5 Years, 6 - 12 Months, and < 6 Months|The prognosis for participants is summarized for each visit by the number of participants at each visit with a survival prognosis of 10 years, 5 - 10 years, 1 - 5 years, 6 - 12 months, and < 6 months. Methods for determining survival prognosis were not prespecified, but were based on the judgement of each Investigator.|time 0 (Baseline), month 3, and every 3 months thereafter until disease progression or up to 24 months, whichever came first|Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data at each visit.||participants|||Number
813807|NCT01081873|Primary|Effectiveness Parameter: the Number of Participants With a Complete or Partial Response, Stable Disease, or Progressive Disease Following Treatment at Each Visit|Response to treatment is summarized by the number of participants at each visit with a complete or partial response, stable disease, or progressive disease. Disease status determination was not predefined, but was based on the judgement of each Investigator.|month 3, and every 3 months until disease progression or up to 24 months, whichever came first|Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data at each visit.||participants|||Number
813808|NCT01081873|Primary|Effectiveness Parameter for Screening or Recurrence of Prostate Cancer: Mean Prostate-specific Antigen (PSA) at Each Visit|The mean PSA in ng/mL to screen and assess for the recurrence of prostate cancer at each visit is presented.|time 0 (Baseline), month 3, and every 3 months until disease progression or up to 24 months, whichever came first|Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data at each visit.||ng/mL||Standard Deviation|Mean
813809|NCT01081873|Primary|Effectiveness Parameter for Staging of Prostate Cancer: Metastases at Each Visit|The number of participants with metastases that are absent, local tumor, single metastases, multiple metastases in 1 organ, and multiple metastases in multiple organs at each visit is summarized.|time 0 (Baseline), month 3, and every 3 months until disease progression or up to 24 months, whichever came first|Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data at each visit.||participants|||Number
813810|NCT01081886|Secondary|Operative Metrics: Operative Time, Estimated Blood Loss, Skin Scarring, Knee Society Score (KSS)||Intraoperatively and 1-2 weeks postoperatively|An integrity audit found that the data for this study could not be analyzed owing to unverifiable source documentation.|||||
813811|NCT01081886|Primary|Post-operative Pain|Wong-Baker FACES Visual Analog Scale, 0 (no hurt) to 10 (hurts worst). The results represent the mean of each subject's mean pain scores over 10 days.|Postoperative (0 to 10 days)|An integrity audit found that the data for this study could not be analyzed owing to unverifiable source documentation.|||||
813812|NCT01081912|Secondary|Mean Change of the Clinic NRS Pain Intensity|The change in pain intensity as measured in the clinic by a 0-10 Numeric Rating Scale (NRS)|Baseline to Day 85 visit||||||
813813|NCT01081912|Primary|Mean Change in 24-hour Pain Intensity Ratings Scale (NRS).|Change in average pain intensity as measured daily by Numeric Rating Scale (NRS) for Pain (0-10; where 0 = no pain, 10 = worst pain imaginable) comparing HC-ER with Placebo. Lower number equals better outcome.|Baseline to Day 85 (Treatment Phase)|The primary efficacy analysis used the Intent to treat (ITT) population which included all 302 randomized subjects.||units on a scale||Standard Deviation|Mean
813814|NCT01081951|Secondary|Percentage Change in Tumour Size|The total tumour size was defined as the sum of the longest diameters of the target lesions. At week 9, the percentage change in tumour size was calculated as [(week 9 sum of target lesions - baseline sum of target lesions)/baseline sum of target lesions]*100 for each patient. Imputations were used for missing data where possible.|Week 9 (+/- 1 week)|FAS, but including only patients with target lesions at baseline||Percentage change||Standard Error|Least Squares Mean
813815|NCT01081951|Secondary|Overall Survival (OS)|OS was defined as the time from randomisation until death by any cause. Patients who had not died at the time of analysis were censored at the last date the patient was known to be alive.|Following disease progression, patients will be contacted every 12 weeks to assess survival status until the final analysis (approximately 50 months)|FAS||Participants (Number of deaths)|||Number
813816|NCT01081951|Primary|Progression Free Survival (PFS)|PFS (based on independent central review) was defined as the time from randomisation until objective disease progression as defined by Response Evaluation Criteria In Solid Tumours (RECIST) v1.1 (≥20% increase in the sum of the diameters of target lesions from minimum, clinically significant progression in non-target lesions or the presence of a new lesion) or death (by any cause in the absence of progression).|Radiologic scans performed at weeks 9 and 18 (+/-1 week) and every 12 weeks thereafter relative to the date of randomisation until the primary analysis (approximately 20 months)|Full Analysis Set (FAS)||months||95% Confidence Interval|Median
813817|NCT01082081|Secondary|Participants Global Assessment to Response to Treatment (PGART)|PGART was measured by a score in a scale from 0-4: 0- Poor; 1- Fair 2- Good; 3- Very Good; 4- Excellent.|Baseline to 6 hours post dose|ITT population: All participants who received study treatment and had at least one post-baseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
814967|NCT01092663|Secondary|Fasting Plamsa Glucagon|To evaluate the effect of treatments on plasma glucagon concentrations.|Baseline and 12 weeks|||picograms (pg)/milliliter (ml)||Standard Deviation|Mean
813818|NCT01082081|Secondary|SPID Scores at 6 Hours|"SPID was calculated as sum of products of Pain Intensity Differences (PID) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240, 240-300 and 300-360. Positive and higher scores indicate greater reduction in pain.
SPIDt = ∑PID x (timet - timet-1)
Pain Intensity was assessed at baseline and at each time-point based on a 4-point categorical Verbal Rating Scale (VRS) scale: 0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain.
If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from pain scores taken at baseline."|Every two hours from baseline to 6 hours post dose|ITT population: All participants who received one study treatment and had at least one post-baseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
813819|NCT01082081|Secondary|SPID Scores at 4 Hours|"SPID was calculated as sum of products of Pain Intensity Differences (PID) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240. Positive and higher scores indicate greater reduction in pain.
SPIDt = ∑PID x (timet - timet-1)
Pain Intensity was assessed at baseline and at each time-point based on a 4-point categorical Verbal Rating Scale (VRS) scale: 0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain.
If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from pain scores taken at baseline."|Every two hours from baseline to 4 hours post dose|ITT population: All participants who received one study treatment and had at least one post-baseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
813820|NCT01082081|Secondary|Sum of Pain Intensity Difference (SPID) Scores at 2 Hours|"SPID was calculated as sum of products of Pain Intensity Differences (PID) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120. Positive and higher scores indicate greater reduction in pain.
SPIDt = ∑PID x (timet - timet-1)
Pain Intensity was assessed at baseline and at each time-point based on a 4-point categorical Verbal Rating Scale (VRS) scale: 0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain.
If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from pain scores taken at baseline."|Every two hours from baseline to 2 hours post dose|ITT population: All participants who received study treatment and had at least one post-baseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
813821|NCT01082081|Secondary|TOTPAR at 6 Hours|"TOTPAR was calculated as sum of products of pain relief (PR) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240, 240-300 and 300-360. Higher score indicated greater pain relief.
TOTPARt = ∑PR x (timet – timet-1).
PR score was assessed at each of the above time-points based on a 5-point categorical scale [0-no relief, 1-little relief, 2-meaningful relief, 3-a lot of relief, 4-complete relief]."|Every two hours from baseline to 6 hours post dose|ITT population: All participants who received one study treatment and had at least one post-baseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
813822|NCT01082081|Secondary|TOTPAR at 4 Hours|"TOTPAR was calculated as sum of products of pain relief (PR) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240. Higher score indicated greater pain relief.
TOTPARt = ∑PR x (timet – timet-1).
PR score was assessed at each of the above time-points based on a 5-point categorical scale [0-no relief, 1-little relief, 2-meaningful relief, 3-a lot of relief, 4-complete relief]."|Every two hours from baseline to 4 hours post dose|ITT population: All participants who received one study treatment and had at least one post-baseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
813823|NCT01082081|Secondary|Total Pain Relief (TOTPAR) at 2 Hours|"TOTPAR was calculated as sum of products of pain relief (PR) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120. Higher score indicated greater pain relief.
TOTPARt = ∑PR x (timet – timet-1).
PR score was assessed at each of the above time-points based on a 5-point categorical scale [0-no relief, 1-little relief, 2-meaningful relief, 3-a lot of relief, 4-complete relief]."|Every two hours from baseline to 2 hours post dose|ITT population: All participants who received study treatment and had at least one post-baseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
813824|NCT01082081|Secondary|SPRID at 4 Hours|SPRID:Sum of Pain Intensity Difference (SPID) and Total Pain Relief (TOTPAR) at each post-dosing time-point. SPRID score ranged from -3.8 (least pain relief) to 26.3 (highest pain relief). SPID and TOTPAR were calculated as weighted sums of Pain Intensity Differences (PID) and Pain Relief Scores (PRS) at each measurement time, respectively. PID was derived by subtracting the pain severity score at a given post-dosing time-point from the baseline [pain severity score range:0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain using a 4-point categorical Verbal Rating Scale (VRS)]. If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from baseline pain scores. PRS was assessed on 5-point categorical pain relief rating scale [0-no relief, 1-little relief, 2-some relief, 3-a lot of relief, 4-complete relief]|Every two hours from baseline to 4 hours post dose|ITT population: All participants who received one study treatment and had at least one post-baseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
813835|NCT01082211|Secondary|Treatment-related Adverse Events Occurring After One Year From Completion of Re-irradiation|AEs were graded with CTCAE version 4. The overall highest grade for each patient is computed from reported adverse events definitely, probably, or possibly related to protocol treatment occurring after one year from completion of re-irradiation.|After 1 year from the end of radiation.|All eligible patients||percentage of participants|||Number
813836|NCT01082211|Secondary|Overall Survival|Failure is death due to any cause. Three-year overall survival rate was estimated using the Kaplan-Meier method.|From registration to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 3 years.|All eligible patients.||percentage of participants||95% Confidence Interval|Number
829997|NCT01235195|Primary|Maximum Observed Plasma Concentration (Cmax)||Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose|All participants.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
813825|NCT01082081|Secondary|SPRID at 2 Hours|SPRID:Sum of Pain Intensity Difference (SPID) and Total Pain Relief (TOTPAR) at each post-dosing time-point. SPRID score ranged from -1.8 (least pain relief) to 12.3 (highest pain relief). SPID and TOTPAR were calculated as weighted sums of Pain Intensity Differences (PID) and Pain Relief Scores (PRS) at each measurement time, respectively. PID was derived by subtracting the pain severity score at a given post-dosing time-point from the baseline [pain severity score range:0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain using a 4-point categorical Verbal Rating Scale (VRS)]. If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from baseline pain scores. PRS was assessed on 5-point categorical pain relief rating scale [0-no relief, 1-little relief, 2-some relief, 3-a lot of relief, 4-complete relief]|Every two hours from baseline to 2 hours post dose|ITT population: All participants who received study treatment and had at least one post-baseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
813826|NCT01082081|Secondary|Percentage of Participants Who Took Rescue Medication During 2 to 6 Hours|Percentage of participants who took rescue medication during 2 to 6 hours|Within 2 to 6 hours post dose|ITT population: All participants who received one study treatment and had at least one post-baseline efficacy assessment.||Percentage of participants|||Number
813827|NCT01082081|Secondary|Percentage of Participants Who Took Rescue Medication Within 2 Hours|Percentage of participants who received rescue medication within 2 hours|Baseline to 2 hours post dose|ITT population: All participants who received one study treatment and had at least one post-baseline efficacy assessment.||Percentage of participants|||Number
813828|NCT01082081|Secondary|Time to Start Using Rescue Medication|Median time of use of rescue medication by participants was calculated.|Baseline to 6 hours post dose|ITT population: All participants who received one study treatment and had at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored.||minutes||Full Range|Median
813829|NCT01082081|Secondary|Time to Onset of Meaningful Pain Relief|Participants evaluated the time to meaningful relief by stopping a second stopwatch when they first began to experience meaningful relief.|Baseline to 6 hours post dose|ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes.||minutes||Standard Deviation|Mean
813830|NCT01082081|Secondary|Time to Confirmed First Perceptible Pain Relief|Participants recorded the time to first perceptible relief by starting the first stopwatch at the time of dosing and stopping it when he/she experienced the first perceptible pain relief. The first perceptible pain relief was confirmed if the participant also stopped the second stopwatch indicating meaningful relief.|Baseline to 6 hours post dose|ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes.||minutes||Standard Deviation|Mean
813831|NCT01082081|Primary|Sum of Pain Relief and Pain Intensity Differences From 0 to 6 Hours (SPRID 6 Hours)|SPRID:Sum of Pain Intensity Difference (SPID) and Total Pain Relief (TOTPAR) at each post-dosing time-point. SPRID score ranged from -5.8 (least pain relief) to 40.3 (highest pain relief). SPID and TOTPAR were calculated as weighted sums of Pain Intensity Differences (PID) and Pain Relief Scores (PRS) at each measurement time, respectively. PID was derived by subtracting the pain severity score at a given post-dosing time-point from the baseline [pain severity score range:0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain using a 4-point categorical Verbal Rating Scale (VRS)]. If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from baseline pain scores. PRS was assessed on 5-point categorical pain relief rating scale [0-no relief, 1-little relief, 2-some relief, 3-a lot of relief, 4-complete relief]|Every two hours from baseline to 6 hours post dose|||Units on a scale||Standard Deviation|Mean
813832|NCT01082159|Primary|Quality of Life Changes as Determined by Short Form 12-question (SF-12) Survey Specifically Related to Physical Component Score (PCS).|The SF-12 is a validated norm-based scoring tool used to determine treatment outcomes. The PCS summary measure shows the impact of the treatment on the patients abilities to conduct their usual physical activities. Clinical relevance of PCS is established by baseline to post-treatment improvement of 2 to 3 points. Norm-based scoring is used so that each scale has the same mean (50 points) and the same standard deviation (10 points) as the general US population in 1998. Scores below 50 indicate a decline in health status, with lower scores representing worse health status. Minimally Important Difference (MID) is a measure of true clinical relevance of a difference, with suggested MID for the Physical Component Summary (PCS) being 2 to 3 points. Change from baseline to 6 months is presented, where a positive value represents the 6 month value minus the baseline value.|Baseline and Month 6|All participants at month 6 who completed all questionnaire fields necessary to analyze PCS data according to guidelines.||units on a scale||95% Confidence Interval|Mean
813833|NCT01082159|Primary|Function as Measured Subjectively by the Oswestry Disability Index Questionnaire|Oswestry Disability Index (ODI) measures permanent functional disability using questions regarding activities of daily living (ADL), specifically disturbance of ADL related to chronic back pain. Higher scores indicate a 'more limited' life. The ten topics of the ODI are rated from zero (no pain/limitation) to five (high pain/very limited physically). The worst possible score is 50 (100% disability) with the best score being zero (0% disability).Change from baseline to 6 months is presented below, where a positive value represents the baseline value minus the 6 month value.|Baseline and Month 6|All available patients at 6 months are reported below.||units on a scale||95% Confidence Interval|Mean
813834|NCT01082159|Primary|Changes in Back Pain as Measured by a 10-point Visual Analog Scale (VAS).|"The 10-point Visual Analog Scale (VAS)rates 'no pain' as zero and 'worst pain imaginable' as ten. VAS mean improvement greater than or equal to 2 points is considered clinically relevant.
The change from baseline to Month 6 is presented below where a positive value represents the baseline value minus the 6 month value."|Baseline and Month 6|All available participants who reported Month 6 outcomes are included in this analysis.||units on a scale||95% Confidence Interval|Mean
814968|NCT01092663|Primary|Fasting Plasma Glucose|Change from baseline in fasting plasma glucose concentrations after 12 weeks of colesevelam or colesevelam plus sitagliptin treatments.|Baseline and 12 weeks|||millimoles (mmol)/Liter (L)||Standard Deviation|Mean
813837|NCT01082211|Secondary|Mastectomy-free Survival|Failure is mastectomy of the treated breast or death due to any cause. Mastectomy-free survival rate at three years was estimated using the Kaplan-Meier method.|From registration to date of mastectomy, death or last follow-up. Analysis occurs after all patients have been potentially followed for 3 years.|All eligible patients.||percentage of participants||95% Confidence Interval|Number
813838|NCT01082211|Secondary|Distant Metastasis-free Survival|Failures are appearance of ipsilateral axillary, infraclavicular, internal mammary, or supraclavicular recurrences; distant metastases confirmed radiographically and/or pathologically; or death due to any cause. Note that a distant metastases was only considered a treatment failure if accompanied by an in-breast recurrence.|From registration to date of distant metastasis, death or last follow-up. Analysis occurs after all patient have been potentially followed for 3 years.|All eligible patients.||percentage of participants||95% Confidence Interval|Number
813839|NCT01082211|Secondary|Cosmesis||After surgery prior to the start of radiation, 1 year from the end of radiation and 3 years from the end of radiation. Analysis occurs after all patients have been potentially followed for 3 years.||01/2018||||
813840|NCT01082211|Secondary|Treatment-related Adverse Events Any Time|AEs were graded with CTCAE version 4. The overall highest grade for each patient is computed from all reported adverse events definitely, probably, or possibly related to protocol treatment.|From the end of radiation to end of follow-up. Will be evaluated at the time of the primary analysis.|All eligible patients||percentage of participants|||Number
813841|NCT01082211|Secondary|Rate of Circulating Tumor Cells||Prior to the start of radiation and 3 weeks after last radiation treatment.||04/2017||||
813842|NCT01082211|Secondary|Freedom From Mastectomy|Failure is mastectomy of the treated breast. Mastectomy rate at 3 years is reported, using the cumulative incidence with death as competing risk. Mastectomy-free survival is reported in outcome measure 10.|From registration to date of mastectomy or last follow-up. Analysis occurs after all patients have been potentially followed for 3 years.|All eligible patients.||percentage of participants||95% Confidence Interval|Number
813843|NCT01082211|Secondary|In-breast Recurrence|The definition of treatment failure is histologic evidence of recurrent carcinoma, either invasive or non-invasive (except LCIS) in the ipsilateral breast. Clinical evidence of carcinoma by physical examination and/or mammograms and/or MRI will not be construed as evidence of treatment failure without biopsy proof but will be considered as suspicious for recurrence. Ipsilateral breast recurrences will be considered local (infield) if they occur within the prescription isodose volume; they will be considered peripheral if they occur between the prescription isodose volume and a volume 2 cm outside of the prescription isodose volume. Ipsilateral recurrences will be considered non-contiguous or extra field if they are beyond the peripheral volume described above.|From registration to date of recurrence or last follow-up. Analysis occurs after all patients have been potentially followed for 3 years.|All eligible patients.||percentage of participants||95% Confidence Interval|Number
813844|NCT01082211|Primary|Grade 3+ Treatment-related Skin, Fibrosis, and Breast Pain Adverse Events|To evaluate the rate of grade 3+ treatment-related skin, fibrosis, and breast pain adverse events (AEs) occurring within 1 year from the completion of reirradiation. Based on a rate of 4% for these AEs, a rate of ≥ 13% for these AEs with re-irradiation would be unacceptable. A sample size of 55 evaluable pts (eligible & started protocol treatment [tx]) will provide: 86% power to conclude an unacceptable rate of the specified AEs, if the true AE rate is at least 13% & 93% probability to not conclude an unacceptable rate of the specified AEs, if the true AE rate is 4%. If ≥ 5 pts have tx-related AEs, then tx-related AE rate considered unacceptable.|From the end of radiation to 1 year.|The first 55 eligible patients who completed treatment and achieved 1 year of follow-up.||participants|||Number
813845|NCT01082328|Secondary|Mean Change From Baseline in Blood Phenylalanine-to-tyrosine Ratio|Phenylalanine-to-tyrosine ratio is the best indicator of dopamine availability in PKU. The change in blood phenylalanine-to-tyrosine ratio at Day 28 was calculated as blood phenylalanine-to-tyrosine ratio at Day 28 minus blood phenylalanine-to-tyrosine ratio at Baseline.|Baseline, Day 28|FAS population included all the participants with a valid Baseline blood Phe level measure and who received at least one dose of Kuvan®. ‘n’ signifies number of participants who were evaluable for specified categories at different time points.||Ratio||Standard Deviation|Mean
813846|NCT01082328|Secondary|Percentage of Early-, Late- and Partial-Responders According to Phenotype|The PKU is categorized as per phenotype into classical PKU: (blood Phe levels > 1200 mcmol/l), mild PKU (blood Phe levels 600 to 1200 mcmol/l), mild HPA (blood Phe levels 300 to 600 mcmol/l). Early responders defined as percentage of participants with at least 30 percent reduction in Phe levels within the first seven days of treatment. Late responders defined as percentage of participants with less than 30 percent reduction in Phe levels within first seven days of treatment, but at least 30 percent reduction in Phe levels within 28 +/- 1 days of treatment. Partial responders defined as percentage of participants with Phe levels reduction between 10 and 30 percent at any blood measurement within the 28 +/- 1 days of treatment.|Baseline up to Day 28 +/- 1|FAS population included all the participants with a valid Baseline blood Phe level measure and who received at least one dose of Kuvan®. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure. 'n' signifies number of participants who were evaluable for specified categories at different time points.||Percentage of participants|||Number
813847|NCT01082328|Secondary|Percentage of Participants With Greater Than or Equal to (>=) 30 Percent, 20 to 30 Percent, 10 to 20 Percent and Less Than (<) 10 Percent Reduction in Blood Phe Levels According to Phenylketonuria (PKU) Phenotypes|The Phenylketonuria (PKU) is categorized as per phenotype into classical PKU: (blood Phe levels greater than [>] 1200 micromole per liter [mcmol/l]), mild PKU (blood Phe levels 600 to 1200 mcmol/l), mild Hyperphenylalaninaemia (HPA) (blood Phe levels 300 to 600 mcmol/l).|Baseline up to Day 28 +/- 1|FAS population included all the participants with a valid Baseline blood Phe level measure and who received at least one dose of Kuvan®. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure. ‘n’ signifies number of participants who were evaluable for specified categories at different time points.||Percentage of participants|||Number
813873|NCT01082380|Primary|Maximum Observed Concentration in Plasma Radioactivity (Cmax)|Radioactivity corresponds to 100 μCi [14C]PF-02341066.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|The radioactivity parameter analysis population included all treated participants who had at least 1 of the radioactivity parameters of primary interest.||nanogram-equivalent/milliliter(ng-eq/mL)||Standard Deviation|Geometric Mean
813848|NCT01082328|Secondary|Percentage of Early-, Late-, Partial-Responders and Non-responders to Treatment With Kuvan®|Early responders defined as percentage of participants with at least 30 percent reduction in Phe levels within the first seven days of treatment. Late responders defined as percentage of participants with less than 30 percent reduction in Phe levels within first seven days of treatment, but at least 30 percent reduction in Phe levels within 28 +/- 1 days of treatment. Partial responders defined as percentage of participants with Phe levels reduction between 10 and 30 percent at any blood measurement within the 28 +/- 1 days of treatment. Non-responders defined as percentage of participants with a Phe level reduction of less than 10 percent within 28 +/- 1 days.|Baseline up to Day 28 +/- 1|FAS population included all the participants with a valid Baseline blood Phe level measure and who received at least one dose of Kuvan®.||Percentage of participants||95% Confidence Interval|Number
813849|NCT01082328|Secondary|Number of Participants With Adverse Events (AEs), Treatment Emergent Adverse Events, Treatment Related Adverse Events and AEs Leading to Withdrawal|An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.|Baseline up to Day 42 +/- 3|Safety population included all the participants with a valid Baseline blood Phe level measure and who received at least one dose of Kuvan®.||Participants|||Number
813850|NCT01082328|Primary|Percentage of Participants With at Least 30 Percent Reduction From Baseline in Blood Phenylalanine (Phe) Level|Response to treatment was defined as 30 percent reduction from Baseline in blood phenylalanine (Phe) Level during the 28 +/- 1 days.|Baseline up to Day 28 +/- 1|Full analysis set (FAS) population included all the participants with a valid Baseline blood Phe level measure and who received at least one dose of Kuvan®.||Percentage of participants||95% Confidence Interval|Number
813851|NCT01082367|Secondary|Percentage of Participants P Aeruginosa-free at Termination of the Double Blind Period|Sputum/throat swab cultures were assessed.|Day 91|Participants from the ITT population, who were tested for microbiology, were included in the analysis.||Percentage of participants|||Number
813852|NCT01082367|Secondary|Percentage of Participants Free From P. Aeruginosa 28 Days After Termination of the Second Treatment Cycle|Sputum/throat swab cultures were assessed.|Day 91|Cross-over participants from the ITT population were analyzed.||Percentage of participants|||Number
813853|NCT01082367|Primary|Percentage of Participants P Aeruginosa-free After Completion of the First Treatment Cycle|Sputum/throat swab cultures were assessed.|Day 29|Intent-to-treat (ITT): The ITT included all randomized participants who received at least dose of study treatment.||Percentage of participants|||Number
813854|NCT01082380|Primary|Identification and Profiling of Metabolites of [14C]PF-02341066 in Urine|In urine, metabolite abundance (profiling) was calculated by multiplying the fractional contribution of radioactive response for the peak in the Radio-HPLC chromatogram to the total radioactivity detected by the percent of administered dose recovered in the matrix. Only those metabolites that were a component of a chromatographic peak that accounted for an average of >=1% of the administered dose, were summarized. Radioactivity corresponds to 100 μCi [14C] PF-02341066.|Predose, 0 to 4, 4 to 8, 8 to 16, 16 to 24 to 36, 36 to 48 hrs and then after every 24 hrs until up to 480 hrs post-dose|The radioactivity parameter analysis population included all treated participants who had at least 1 of the radioactivity parameters of primary interest.||Percentage of radioactive dose|||Number
813855|NCT01082380|Primary|Identification and Profiling of Metabolites of [14C]PF-02341066 in Feces|In feces, metabolite abundance (profiling) was calculated by multiplying the fractional contribution of radioactive response for the peak in the Radio-HPLC chromatogram to the total radioactivity detected by the percent of administered dose recovered in the matrix. Only those metabolites that were a component of a chromatographic peak that accounted for an average of >=1% of the administered dose, were summarized. Radioactivity corresponds to 100 μCi [14C] PF-02341066.|From Day 0 through pre-dose (Day1) and as passed through until up to 480 hrs post-dose|The radioactivity parameter analysis population included all treated participants who had at least 1 of the radioactivity parameters of primary interest.||Percentage of radioactive dose|||Number
813856|NCT01082380|Primary|Identification and Profiling of Metabolites of [14C]PF-02341066 in Plasma|Identification was done by Radio-High Performance liquid chromatography (HPLC) chromatogram. Relative abundance (profiling) of metabolites in chromatogram were determined by dividing sum of radioactive content of fractions contributing to particular peak by sum of radioactive content of all fractions constructing the radio chromatogram. Metabolites accounting for an average of greater than or equal to (>=) 10% of total recoverable radioactivity in plasma were summarized. Radioactivity corresponds to 100 μCi [14C] PF-02341066.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|The radioactivity parameter analysis population included all treated participants who had at least 1 of the radioactivity parameters of primary interest.||Percentage of recovered radioactivity|||Number
813857|NCT01082380|Primary|Overall Cumulative Percent Recovery of Radioactivity|Overall cumulative percent of radioactive dose recovered in urine, feces and toilet tissue at specified intervals after administration of a single 250-mg (100 μCi) oral dose of [14C]PF-02341066.|Pre-dose, 0 to 4, 4 to 8, 8 to 16, 16 to 24 to 36, 36 to 48 hrs and then after every 24 hrs until up to 480 hrs post-dose for urine and Day 0 through pre-dose (Day1) and as passed through until up to 480 hrs post-dose for feces|The radioactivity parameter analysis population included all treated participants who had at least 1 of the radioactivity parameters of primary interest.||Percent recovery of radioactivity||Standard Deviation|Mean
813858|NCT01082380|Primary|Total [14C] Data in Feces|Cumulative amount excreted in feces at specified intervals after administration of a single 250-mg (100 μCi) oral dose of [14C]PF-02341066.|From Day 0 through pre-dose (Day1) and as passed through until up to 480 hrs post-dose|The radioactivity parameter analysis population included all treated participants who had at least 1 of the radioactivity parameters of primary interest.||ng-eq||Standard Deviation|Mean
813859|NCT01082380|Primary|Total [14C] Data in Urine|Cumulative amount excreted in urine at specified intervals after administration of a single 250-mg (100 μCi) oral dose of [14C]PF-02341066.|Predose, 0 to 4, 4 to 8, 8 to 16, 16 to 24 to 36, 36 to 48 hrs and then after every 24 hrs until up to 480 hrs post-dose|The radioactivity parameter analysis population included all treated participants who had at least 1 of the radioactivity parameters of primary interest.||ng-eq||Standard Deviation|Mean
813860|NCT01082380|Primary|Apparent Volume of Distribution of Radioactivity in Whole Blood (V/F)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Apparent volume of distribution after oral dose (V/F) is influenced by the fraction absorbed. Radioactivity corresponds to 100 μCi [14C]PF-02341066.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|Data was insufficient to analyze as only 2 participants were evaluable for the parameter.||L||Standard Deviation|Geometric Mean
813861|NCT01082380|Primary|Apparent Oral Clearance of Radioactivity From Whole Blood (CL/F)|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Radioactivity corresponds to 100 μCi [14C]PF-02341066.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|Data was insufficient to analyze as only 2 participants were evaluable for the parameter.||L/hr||Standard Deviation|Geometric Mean
813862|NCT01082380|Primary|Decay Half-life (t1/2) of Radioactivity in Whole Blood|Decay half life (t1/2) is the time measured for the concentration to decrease by one half in whole blood. Radioactivity corresponds to 100 μCi [14C]PF-02341066.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|Data was insufficient to analyze as only 2 participants were evaluable for the parameter.||hr||Standard Deviation|Mean
813863|NCT01082380|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Radioactivity in Whole Blood|Area under the concentration curve from time zero to extrapolated infinite time [AUC (0 - ∞)] in whole blood. Radioactivity corresponds to 100 μCi [14C]PF-02341066.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|Data was insufficient to analyze as only 2 participants were evaluable for the parameter.||ng-eq*hr/mL||Standard Deviation|Geometric Mean
813864|NCT01082380|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Radioactivity in Whole Blood|Area under the concentration time-curve from zero to the last measured concentration (AUClast) in whole blood. Radioactivity corresponds to 100 μCi [14C]PF-02341066.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|The radioactivity parameter analysis population included all treated participants who had at least 1 of the radioactivity parameters of primary interest.||ng-eq*hr/mL||Standard Deviation|Geometric Mean
813865|NCT01082380|Primary|Time to Reach Maximum Observed Concentration (Tmax) of Radioactivity in Whole Blood|Time to Reach Maximum Observed Concentration (Tmax) of Radioactivity in whole blood. Radioactivity corresponds to 100 μCi [14C]PF-02341066.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|The radioactivity parameter analysis population included all treated participants who had at least 1 of the radioactivity parameters of primary interest.||hr||Full Range|Median
813866|NCT01082380|Primary|Maximum Observed Concentration of Radioactivity in Whole Blood (Cmax)|Radioactivity corresponds to 100 μCi [14C]PF-02341066.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|The radioactivity parameter analysis population included all treated participants who had at least 1 of the radioactivity parameters of primary interest.||ng-eq/mL||Standard Deviation|Geometric Mean
813867|NCT01082380|Primary|Apparent Volume of Distribution (V/F) in Plasma Radioactivity|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Apparent volume of distribution after oral dose (V/F) is influenced by the fraction absorbed. Radioactivity corresponds to 100 μCi [14C]PF-02341066.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|Data was insufficient to analyze as only 2 participants were evaluable for the parameter.||L||Standard Deviation|Geometric Mean
813868|NCT01082380|Primary|Apparent Oral Clearance (CL/F) of Plasma Radioactivity|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Radioactivity corresponds to 100 μCi [14C]PF-02341066.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|Data was insufficient to analyze as only 2 participants were evaluable for the parameter.||L/hr||Standard Deviation|Geometric Mean
813869|NCT01082380|Primary|Decay Half Life (t1/2) of Radioactivity in Plasma|Plasma decay half-life is the time measured for the plasma radioactivity concentration to decrease by one half. Radioactivity corresponds to 100 μCi [14C]PF-02341066.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|Data was insufficient to analyze as only 2 participants were evaluable for the parameter.||hr||Standard Deviation|Mean
813870|NCT01082380|Primary|Area Under the Plasma Radioactivity Concentration Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]|Area under the concentration curve from time zero to extrapolated infinite time [AUC (0 - ∞)] in plasma. Radioactivity corresponds to 100 μCi [14C]PF-02341066.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|Data was insufficient to analyze as only 2 participants were evaluable for the parameter.||ng-eq*hr/mL||Standard Deviation|Geometric Mean
813871|NCT01082380|Primary|Area Under the Curve From Time Zero to Last Quantifiable Plasma Radioactivity Concentration (AUClast)|Area under the concentration time-curve from zero to the last measured plasma concentration. Radioactivity corresponds to 100 μCi [14C]PF-02341066.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|The radioactivity parameter analysis population included all treated participants who had at least 1 of the radioactivity parameters of primary interest.||ng-eq*hr/mL||Standard Deviation|Geometric Mean
813872|NCT01082380|Primary|Time to Reach Maximum Observed Plasma Radioactivity Concentration (Tmax)|Radioactivity corresponds to 100 μCi [14C]PF-02341066.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|The radioactivity parameter analysis population included all treated participants who had at least 1 of the radioactivity parameters of primary interest.||hr||Full Range|Median
813947|NCT01083186|Secondary|Glycosylated Hemoglobin A1c (HbA1c) Values Throughout the Study|The HbA1c normal range was 4.3-6.1%.|Baseline, Enrollment Visit, Month 6, Month 12|All participants. n=number of participants with evaluable data at given time-points.||percent||Standard Deviation|Mean
813874|NCT01082380|Primary|Total Amount of Unchanged Drug Excreted in the Urine Expressed as Percent of Dose From Time Zero to Infinite Time [Ae(%)]||Predose, 0 to 4, 4 to 8, 8 to 16, 16 to 24 to 36, 36 to 48 hrs and then after every 24 hrs until up to 480 hrs post-dose|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest.||Percent dose of unchanged drug||Standard Deviation|Geometric Mean
813875|NCT01082380|Primary|Total Amount of Unchanged Drug Excreted in the Urine From Time Zero to Infinite Time (Ae)|Ae = concentration of unchanged drug excreted in the urine multiplied by volume of unchanged drug excreted in urine.|Predose, 0 to 4, 4 to 8, 8 to 16, 16 to 24 to 36, 36 to 48 hrs and then after every 24 hrs until up to 480 hrs post-dose|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest.||mg||Standard Deviation|Geometric Mean
813876|NCT01082380|Primary|Renal Clearance (CLr) of PF-02341066|CLr is the volume of plasma from which a substance is completely removed by the kidney in a given amount of time.|Predose, 0 to 4, 4 to 8, 8 to 16, 16 to 24 to 36, 36 to 48 hrs and then after every 24 hrs until up to 480 hrs post-dose|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest.||L/hr||Standard Deviation|Geometric Mean
813877|NCT01082380|Primary|Apparent Volume of Distribution (V/F) in Plasma|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Apparent volume of distribution after oral dose (V/F) is influenced by the fraction absorbed.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest.||L||Standard Deviation|Geometric Mean
813878|NCT01082380|Primary|Apparent Oral Clearance (CL/F) of Plasma PF-02341066|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest.||L/hr||Standard Deviation|Geometric Mean
813879|NCT01082380|Primary|Plasma Decay Half Life (t1/2)|Plasma Decay half-life is the time measured for the concentration to decrease by one half.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest.||hr||Standard Deviation|Mean
813880|NCT01082380|Primary|Area Under the Plasma Concentration Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest.||ng*hr/mL||Standard Deviation|Geometric Mean
813881|NCT01082380|Primary|Area Under the Curve From Time Zero to Last Quantifiable Plasma Concentration (AUClast)|Area under the concentration time-curve from zero to the last measured plasma concentration (AUClast).|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest.||ng*hr/mL||Standard Deviation|Geometric Mean
813882|NCT01082380|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest.||hr||Full Range|Median
813883|NCT01082380|Primary|Maximum Observed Plasma Concentration (Cmax)||Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hours (hrs), 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|The Pharmacokinetic (PK) parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest.||ng/mL||Standard Deviation|Geometric Mean
813884|NCT01082575|Primary|Number of General Care Floor Patients Exhibiting a Saturation Pattern Detection (SPD) Alert.|Number of patients on the General care Floor in which a SPD (Saturation Pattern Detection) Alert occurs. Each patient wore a sensor on their finger continuously after surgery for up to 5 days. The sensor was attached to a Nellcor N600X oximeter which measures blood oxygen level. A SPD alert detects a patient's blood oxygen level that is increasing and decreasing in a pattern that is associated with periods of no breathing.|5 days|93 evaluable patients out of 100 enrolled.||participants|||Number
813885|NCT01082575|Secondary|Number of Participants With Adverse Events (AE) Caused by no Breathing|Number of participants with Airway Obstruction that caused the patient to stop breathing Number of participants with Cardiac arrest w/resuscitation caused by the patient not breathing|Five Nights|All enrolled patients||participants|||Number
813886|NCT01082588|Primary|Change in Positive and Negative Syndrome Scale (PANSS) General Score From Baseline to Week 12|This is a subscale of the Positive and Negative Syndrome Scale (PANSS). The range for this subscale is 15-105. All items are summed to calculate the total score. Better outcomes have lower numbers and worse outcomes have higher numbers.|Baseline, week 12|||Scores on a scale||Standard Deviation|Mean
813887|NCT01082588|Primary|Change in Positive and Negative Syndrome Scale (PANSS) Negative Score From Baseline to Week 12|This is a subscale of the Positive and Negative Syndrome Scale (PANSS). The range for this subscale is 7-49. All items are summed to calculate the total score. Better outcomes have lower numbers and worse outcomes have higher numbers.|Baseline, week 12|||Scores on a scale||Standard Deviation|Mean
813888|NCT01082588|Primary|Change in Positive and Negative Syndrome Scale (PANSS) Positive Score From Baseline to Week 12|This is a subscale of the Positive and Negative Syndrome Scale (PANSS). The range for this subscale is 7-49. All items are summed to calculate the total score. Better outcomes have lower numbers and worse outcomes have higher numbers.|Baseline, week 12|||Scores on a scale||Standard Deviation|Mean
814256|NCT01078376|Primary|Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC[0-inf]) for TAK-536|Area under the plasma concentration-time curve from time 0 to infinity, calculated as AUC(0-inf)=AUC(0-tlqc) + Clast/λz.|Day 1|Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.||ng.hr/mL||Standard Deviation|Mean
813889|NCT01082588|Primary|Change in Positive and Negative Syndrome Scale (PANSS) Total Score From Baseline to Week 12|The Positive and Negative Syndrome Scale (PANSS) is a scale used to rate severity of schizophrenia. All items are summed to calculate the total score. The scale range is 30-210. Better outcomes have lower numbers and worse outcomes have higher numbers.|Baseline, week 12|||Scores on a scale||Standard Deviation|Mean
813890|NCT01082588|Primary|Change in MATRICS Neuropsychological Battery Composite Score From Baseline to Week 12|"The Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery measures cognitive functioning within 7 domains: speed of processing, attention/vigilance, working memory (non verbal and verbal), verbal learning, visual learning, reasoning and problem solving and social cognition.
The composite score is calculated by the MATRICS computer program, which equally weights each of the 7 domain scores. The range of composite scores is 20-80. Higher scores indicate higher levels or cognitive functioning, while lower scores indicate lower levels of cognitive functioning."|Baseline, week 12|One participant from the placebo group refused to complete the MATRICS assessment at week 12; therefore, we could only analyze 24 placebo participants for the final analysis.||Scores on a scale||Standard Deviation|Mean
813891|NCT01082588|Primary|Change in C-Reactive Protein (CRP) From Baseline to Week 12||Baseline, week 12|||mg/L||Standard Deviation|Mean
813892|NCT01082588|Primary|Change in LDL-cholesterol Between Baseline and Week 12||Baseline, week 12|One participant from the pravastatin group and two from the placebo group had triglyceride levels above 400. Per Massachusetts General Hospital Laboratories policy, LDL is not run as a part of the complete metabolic panel (CMP) when triglycerides are above 400, and therefore could not be included in the final analysis.||mg/dl||Standard Deviation|Mean
813893|NCT01082614|Secondary|Quality of Recovery Score|Measure of quality of recovery using scoring system; assessed by patient and nursing team|From end of surgery to within one month||||||
813894|NCT01082614|Primary|Length of Postoperative Hospital Stay|time in days from end of surgery to hospital discharge|within one month|||Days||Full Range|Mean
813895|NCT01082640|Secondary|Mean Area Under the Concentration-Time Curve During the Dosing Interval (AUC[0-τ]) of Febuxostat at Steady State|Mean AUC during the dosing interval at steady state was estimated using a population pharmacokinetic (PK) approach, based on 2 PK samples collected prior to dosing, and 4 PK samples collected postdose.|The 2 pre-dose PK samples collected were collected at any 2 of the following visits: Months 3, 6, 9, and/or 12, at -0.25 to 0 hours. The 4 postdose PK samples were collected at Months 3, 6, and/or 9, at 0.25; 0.75 to 2.0; 2.5 to 4.0; and 5 to 12 hours.|Participants who received febuxostat and had available data for PK analysis.||hr*µg/mL||Standard Deviation|Mean
813896|NCT01082640|Secondary|Mean Clearance (CL/F) of Febuxostat at Steady State|Mean CL/F at steady state were estimated using a population pharmacokinetic (PK) approach, based on 2 PK samples collected prior to dosing, and 4 PK samples collected postdose.|The 2 pre-dose PK samples collected were collected at any 2 of the following visits: Months 3, 6, 9, and/or 12, at -0.25 to 0 hours. The 4 postdose PK samples were collected at Months 3, 6, and/or 9, at 0.25; 0.75 to 2.0; 2.5 to 4.0; and 5 to 12 hours.|Participants who received febuxostat and had available data for PK analysis.||liters/hour||Standard Deviation|Mean
813897|NCT01082640|Secondary|Percentage of Participants With Serum Urate (sUA) Less Than 6 mg/dL at Month 12|Serum urate concentrations were determined using the enzymatic method as performed by the Central Laboratory.|Month 12|Full analysis set, including all patients who were randomized and received at least 1 dose of double-blind study medication. A patient was included in the analysis only when there was at least 1 value during the double-blind treatment period. Missing data were imputed as carrying forward the last observed post-baseline value.||percentage of participants|||Number
813898|NCT01082640|Secondary|Change From Baseline to Month 12 in Estimated Glomerular Filtration Rate (eGFR)|Change from baseline to Month 12 in estimated Glomerular Filtration Rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) formula (as calculated by the central laboratory).|Baseline and Month 12|Full analysis set with available data at Baseline. and at least 1 post-baseline value. Missing data was imputed as carrying forward the last post-baseline value.||mL/min/1.73m²||Standard Error|Least Squares Mean
813899|NCT01082640|Primary|Change From Baseline to Month 12 in Serum Creatinine|Renal function was assessed by measuring the change from Baseline in serum creatinine. Analyses were conducted by the Central Laboratory.|Baseline and Month 12|Full analysis set, including all patients who were randomized and received at least 1 dose of double-blind study medication. Only patients with both a baseline value and at least 1 value during the double-blind treatment period are included in the analysis. Missing data were imputed as carrying forward the last observed post-baseline value.||mg/dL||Standard Error|Least Squares Mean
813900|NCT01082874|Secondary|Individual Secondary Outcomes at 1 Year|All cause mortality, vascular mortality, MI, nonfatal cardiac arrest, cardiac revascularization procedure, stroke, pulmonary emboli, deep venous thrombosis, amputation, peripheral arterial thrombosis, new diagnosis of cancer, diagnosis of recurrent cancer and rehospitalization for vascular reason.|1 year||||||
813901|NCT01082874|Secondary|Composite Outcome at 1 Year|All-cause mortality, nonfatal MI, and nonfatal stroke.|1 year||||||
813902|NCT01082874|Secondary|Safety Outcomes in Clonidine Trial|Stroke, clinically important hypotension, clinically important bradycardia, and congestive heart failure.|30 days||||||
813903|NCT01082874|Secondary|Safety Outcomes in ASA Trial|Stroke, congestive heart failure, life-threatening bleeding, and major bleeding.|30 days||||||
813904|NCT01082874|Secondary|Composite Outcome by ASA Stratum|Composite outcome of all-cause mortality, nonfatal MI, cardiac revascularization procedure, nonfatal pulmonary emboli, and nonfatal deep venous thrombosis.|30 days||||||
813905|NCT01082874|Secondary|Individual Secondary Outcomes|All-cause mortality, vascular mortality, MI, nonfatal cardiac arrest, cardiac revascularization procedure, pulmonary emboli, deep venous thrombosis, clinically important atrial fibrillation, amputation, peripheral arterial thrombosis, infection/sepsis, rehospitalization for vascular reasons, length of hospital stay, length of intensive care unit / cardiac care unit (ICU/CCU) stay, and new acute renal failure requiring dialysis.|30 days||||||
813906|NCT01082874|Secondary|Composite of All-cause Mortality, Nonfatal MI, and Nonfatal Stroke||30 days||||||
813907|NCT01082874|Primary|All-cause Mortality and Nonfatal MI||1 year||||||
813908|NCT01082874|Primary|Composite of All-cause Mortality and Nonfatal MI||30 days|||participants|||Number
813909|NCT01082939|Primary|Number of Participants With an Overall Response|Overall (OR) is the total number of participants with any response: Complete remission (CR), is defined as > 30% lymphocytes in the bone marrow, recovery of blood counts and no clinical symptoms; Nodular partial remission (NPR), is the same as CR but with nodules; Partial remission (PR) is > 50% decrease of clinical symptoms from baseline and recovery from blood counts.|6 cycles of treatment (28 days per cycle)|||Participants|||Number
813910|NCT01082952|Secondary|Fold Increase in ASM Cells Proliferation Following Treatment With Cysteinyl Leukotrienes|The effect of Eosinophil release of Cysteinyl Leukotrienes on ASM proliferation was determined using blocking agents. This was determined using Ki-67 staining and flowcytometry.|one day|Eosinophils were collected from all the participants and used to trigger ASM proliferation.||Fold increase in ASM proliferation||Standard Deviation|Mean
813911|NCT01082952|Primary|Fold Increase in ASM Proliferation Following Incubation With Eosinophils.|Airway Smooth Muscle (ASM) cell proliferation was measured 24 hrs following their co-culture with eosinophil. This was determined using Ki-67 staining and flowcytometry. The fold increase in ASM proliferation was then determined.|one day|The number of participants for each group was determined to insure proper statistical significance when analysing the effect of isolated eosinophils on ASM cells proliferation||Fold increase in ASM cell proliferation||Standard Deviation|Mean
813912|NCT01082965|Secondary|Change From Baseline in CogState Test Battery at Hour 5 on Day 1 and at Hour 0, 5 on Day 8|Computerized test battery used to assess detection and identification task. CogState detection task: a measure of simple reaction time, provided valid assessment of psychomotor function. Participants were required to press a “YES” response key as soon as they detected an event (a card turning face up presented in center of the computer screen). The software measured the response time to detect each event. CogState identification task: measure of choice reaction time, provided a valid assessment of visual attention. Participants were required to decide “YES” or “NO” as to whether the event met a predefined and unchanging criterion (is the color of the card red?) while the event (a card turning face up) occurred in the center of the computer screen. The software measured the speed and accuracy of each response.|Baseline, 5 hours post-dose on Day 1; 1, 5 hours post-dose on Day 8|FAS included all randomized participants who received at least 1 dose of the study drug (donepezil or placebo). Here, 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure. n=participants who were evaluable at specific time points for each arm group, respectively.||log10 milliseconds||Standard Deviation|Mean
813913|NCT01082965|Secondary|Change From Baseline in Rey Auditory Verbal Learning Test (RAVLT): Immediate and Delayed Recall at Hour 5 on Day 8|RAVLT, in immediate recall (IR) list of 15 words (list A) was read aloud to participant 5 times followed by a test of spontaneous retrieval (A1 to A5). After fifth attempt a list of interference, comprising 15 words (list B) was read to participant followed by its retrieval (B1). After attempt B1 examiner asked individual to recall words from list A, without reading it again (A6). Score range: 0-105, higher scores=less impairment. Delayed recall (DR):after a 20-minute interval examiner asked individual to remember words from list A without reading this list; in recognition performance a list comprising 15 words from list A, 15 words from list B, 20 distracting words (similar to words in list A, B) was read to individual. Upon each word read aloud, individual asked to indicate if it belonged to list A, or not. Score range: 0-30, higher scores=less impairment.|Baseline, 5 hours post-dose on Day 8|FAS included all randomized participants who received at least 1 dose of the study drug (donepezil or placebo). Here, 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure. n=participants who were evaluable at specified time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
813914|NCT01082965|Secondary|Change From Baseline in CogState Continuous Paired Associate Learning (CPAL) at Hour 5 on Day 1 and at Hour 1, 5 on Day 8|CPAL: a cognitive test which assessed visual episodic learning. Participant was to learn and remember picture locations on the screen and was to tap the target on the central location to begin. As each picture was revealed, the participant was to remember where the picture was located and tap that location. After 4 pictures were placed correctly, second round started. In second round pictures remain in the same locations, but their order of presentation in the center of the screen was different to that of the first round (randomized). The same process was repeated for round 3 and round 4. The outcome was the number of errors made in correctly placing each of the 4 patterns in their location 4 times.|Baseline, 5 hours post-dose on Day 1; 1, 5 hours post-dose on Day 8|FAS included all randomized participants who received at least 1 dose of the study drug (donepezil or placebo). Here, 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure. n=participants who were evaluable at specified time points for each arm group, respectively.||errors||Standard Deviation|Mean
813915|NCT01082965|Secondary|Change From Baseline in Arterial Spin Label (ASL) Perfusion at Hour 4 on Day 1 and at Hour 0, 4 on Day 8|Perfusion in anterior cingulate cortex, medial prefrontal cortex, precuneus, inferior parietal cortex and other regions of interest (whole brain gray, superior, medial and inferior temporal cortex; inferior and superior prefrontal cortex; insula, amygdala, thalamus, basal ganglia, hippocampus, Landau) was measured by ASL technique. ASL is a completely noninvasive magnetic resonance method to measure regional cerebral perfusion. Results are reported for relative perfusion rate. Relative perfusion rate is defined as the absolute perfusion rate divided by the whole brain absolute perfusion rate at the same time point.|Baseline, 4 hours post-dose on Day 1, 1 minute post-dose (Hour 0), 4 hours post-dose on Day 8|FAS included all randomized participants who received at least 1 dose of the study drug (donepezil or placebo). Here, 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.||ratio||Standard Deviation|Mean
813916|NCT01082965|Primary|Change From Baseline in Posterior Cingulate Cortex Perfusion at Hour 4 on Day 8|Posterior cingulate cortex perfusion was measured by ASL. ASL is a completely noninvasive magnetic resonance method to measure regional cerebral perfusion. Results are reported for average relative perfusion rate. Average relative perfusion rate is defined as the average absolute perfusion rate divided by the whole brain absolute perfusion rate at the same time point. Average absolute perfusion rate is the average of left absolute perfusion rate and right absolute perfusion rate at the same time point.|Baseline, 4 hours post-dose on Day 8|FAS included all randomized participants who received at least 1 dose of the study drug (donepezil or placebo). Here, 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.||ratio||Standard Deviation|Mean
814969|NCT01092663|Secondary|Fasting Plasma C-peptide|To evaluate the effect of treatments on plamsa C-peptide concentrations.|Baseline and 12 weeks|||picomoles (pmol)/Liter (L)||Standard Deviation|Mean
813917|NCT01082965|Primary|Change From Baseline in Posterior Cingulate Cortex Perfusion at Hour 0 on Day 8|Posterior cingulate cortex perfusion was measured by ASL. ASL is a completely noninvasive magnetic resonance method to measure regional cerebral perfusion. Results are reported for average relative perfusion rate. Average relative perfusion rate is defined as the average absolute perfusion rate divided by the whole brain absolute perfusion rate at the same time point. Average absolute perfusion rate is the average of left absolute perfusion rate and right absolute perfusion rate at the same time point.|Baseline, 1 minute post-dose (Hour 0) on Day 8|FAS included all randomized participants who received at least 1 dose of the study drug (donepezil or placebo). Here, 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.||ratio||Standard Deviation|Mean
813918|NCT01082965|Primary|Change From Baseline in Posterior Cingulate Cortex Perfusion at Hour 4 on Day 1|Posterior cingulate cortex perfusion was measured by arterial spin labeling (ASL). ASL is a completely noninvasive magnetic resonance method to measure regional cerebral perfusion. Results are reported for average relative perfusion rate. Average relative perfusion rate is defined as the average absolute perfusion rate divided by the whole brain absolute perfusion rate at the same time point. Average absolute perfusion rate is the average of left absolute perfusion rate and right absolute perfusion rate at the same time point.|Baseline, 4 hours post-dose on Day 1|Full analysis set (FAS) included all randomized participants who received at least 1 dose of the study drug (donepezil or placebo). Here, 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.||ratio||Standard Deviation|Mean
813919|NCT01083121|Secondary|Physician's Global Assessment for Effectiveness|The investigator's overall assessment for effectiveness was recorded as 'Improved', 'No change', 'Aggravated,' or 'Not assessable'.|After 3-month treatment|Effectiveness evaluation was performed in 1,471 participants who received adalimumab for at least 3 months and in whom investigator's assessment at 3 months was available. No participants were available in the Psoriasis group for effectiveness evaluation.||participants|||Number
813920|NCT01083121|Primary|Number of Participants With Adverse Events (AEs)|An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. An Adverse Drug Reaction (ADR) is any noxious and undesired reaction related to an experimental drug or experiment. A serious AE (SAE) is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome. AEs were rated for severity as either Mild: transient and easily tolerated; Moderate: causes discomfort and interrupts usual activities; or Severe: causes considerable interference with usual activities, may be incapacitating or life-threatening. AEs related to adalimumab were assessed as being either probably or possibly related by the investigator. An Unexpected ADR is an ADR for which the nature or gravity is not consistent with the applicable product information.|From Baseline until up to 70 days after the 3 month study period (total of 160 days).|Safety analysis population||participants|||Number
813921|NCT01083160|Secondary|Evaluate the Compliance and Clinical Tolerability With Adalimumab|To assess compliance, participants were asked at the Week 8 and Week 16 visits how many doses they had missed since their previous visit. Adverse events were collected throughout the study, from the time the participant signed the informed consent form until 30 days or 5 half-lives after the last dose of study drug. For additional information see the Reported Adverse Event section.|Baseline to Week 24|Analysis population included all participants enrolled in the study who took at least one dose of adalimumab.||Participants|||Number
813922|NCT01083160|Primary|Severity of Pain in a 100mm Visual Analogue Scale (VAS 100mm)|Participants assessed the severity of their pain using a 0 to 100 mm horizontal visual analogue scale (VAS). The far left end indicated no pain (0 mm) and the far right meant the worst possible pain (100 mm). Participants drew a vertical line on the horizontal scale to indicate their current level of pain at each visit.|Baseline and Weeks 8,16 and 24|Analysis conducted in participants with results at each time point.||Units on a scale||Standard Deviation|Mean
813923|NCT01083160|Primary|Tender Joint Count and Swollen Joint Count|The treating physician was to clinically assess each participant at each study visit and report the number of tender and swollen joints. The mean number of painful or swollen joints for participants evaluated at each time point are presented.|Baseline and Weeks 8,16 and 24|Analysis conducted in participants with results at each time point.||Joints||Standard Deviation|Mean
813924|NCT01083160|Primary|DAS28 (Disease Activity Score in 28 Joints)|"The DAS 28 index measures disease activity in rheumatoid arthritis and is derived from the number swollen/tender joints, laboratory tests of inflammation, and participant assessment of global health (by marking a 10 cm line from very good to very bad). Ranges were used to classify participants, with a higher score indicating worse control of disease: Remission (<= 2.6), Low Disease Activity (>2.6 to <=3.2), Moderate Disease Activity (>3.2 to <= 5.1) and High Disease Activity (>5.1). The mean change in DAS 28 score from baseline to each visit is presented."|Baseline and Weeks 8,16 and 24|Analysis conducted in participants with results at each time point.||units on a scale||Standard Deviation|Mean
813925|NCT01083173|Primary|Percentage of Participants With Viral Load Below 50 Copies/mL|Blood samples were obtained from participants 48 weeks after the start of Kaletra treatment, and analyzed for human immunodeficiency virus-1 (HIV-1) RNA levels.|Week 48|Participants with available data||percentage of participants|||Number
813926|NCT01083173|Secondary|Mean Time to Treatment Failure|Blood samples were obtained from participants at initiation of Kaletra treatment and at follow up visits through weeks 24 and 48 and analyzed for human immunodeficiency virus-1 (HIV-1) RNA levels. Treatment failure was defined as HIV RNA level > 400 copies/mL at week 24 and HIV RNA level > 50 copies/mL at week 48.|From baseline through weeks 24 and 48|Participants with available data||days||Standard Error|Mean
813927|NCT01083173|Secondary|Percentage of Participants With Confirmed Viral Resistance|Blood samples were obtained from participants at initiation of Kaletra treatment and follow up visits through weeks 24 and 48 and analyzed for genotypic viral resistance.|From baseline through weeks 24 and 48|Participants with available data||percentage of participants|||Number
813948|NCT01083186|Secondary|Change in Dipstick Albuminuria Grade From Baseline to Month 12|The values “-, Trace, +, ++, and +++” are taken directly from the dipstick measurements, and represent a range from none to highest albuminuria. Data presented shows the number of participants with each value both at Baseline and at Month 6.|Baseline, Month 12|Number of participants with evaluable data at both Baseline and Visit 5 (12 Months Post-Enrollment)||participants|||Number
813928|NCT01083173|Secondary|Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Counts|Blood samples were obtained from participants at baseline, 24, and 48 weeks after the start of Kaletra treatment and analyzed for CD4 cell counts. Change in CD4 cell counts in the main surveillance population was calculated by subtracting the value at baseline from the value at 24 weeks. Change in CD4 cell counts in the long-term surveillance population was calculated by subtracting the value at baseline from the value at 48 weeks.|From baseline to Weeks 24 and 48|Participants with available data||cells/mm˄3||Standard Deviation|Mean
813929|NCT01083173|Secondary|Change From Baseline in Viral Load|This variable, change from baseline in viral load, was not included in the final protocol. Therefore, these data were not calculated.|Week 24 & 48||||||
813930|NCT01083173|Primary|Percentage of Participants With Viral Load Below 400 Copies/mL|Blood samples were obtained from participants 24 weeks after the start of Kaletra treatment, and analyzed for human immunodeficiency virus-1 (HIV-1) RNA levels.|Week 24|Participants with available data||percentage of participants|||Number
813931|NCT01083173|Primary|Number of Participants Who Interrupted or Discontinued Kaletra Treatment|At 24 and 48 weeks after initiation of Kaletra treatment or upon permanent discontinuation of Kaletra treatment, the investigator documented Kaletra status (on-going, permanently discontinued, lost to follow-up, etc).|Weeks 24 and 48 after initiation of Kaletra treatment or upon permanent discontinuation of Kaletra treatment|Participants with available data||participants|||Number
813932|NCT01083173|Primary|Number of Participants With Adverse Events|Adverse events were recorded during the 48-week surveillance period and until 30 days following the last dose.|From the start of treatment until 30 days after the last dose, up to 52 weeks|Participants with available data||participants|||Number
813933|NCT01083186|Secondary|Homocysteine Values Throughout the Study|The homocysteine normal range 3.5-20 μmol/L.|Baseline, Enrollment Visit, Month 6, Month 12|All participants. n=the number of participants with evaluable data at given time-points.||μmol/L||Standard Deviation|Mean
813934|NCT01083186|Secondary|Change From Baseline in C-Reactive Protein (CRP) Levels at Months 6 and 12|The CRP normal range was 0-0.6 mg/dL.|Baseline, Month 6, Month 12|All participants. n=number of participants with evaluable data at given time-points.||mg/dL||Standard Deviation|Mean
813935|NCT01083186|Secondary|Change From Enrollment in High Density Lipoprotein Cholesterol (HDL-C) Levels at Months 6 and 12|The HDL-C normal range was 35-90 mg/dL.|Enrollment, Month 6, Month 12|All participants. n=number of participants with evaluable data at given time-points.||mg/dL||Standard Deviation|Mean
813936|NCT01083186|Secondary|Change From Enrollment in Low Density Lipoprotein Cholesterol (LDL-C) Levels at Months 6 and 12|The LDL-C normal range was 0-150 mg/dL.|Enrollment, Month 6, Month 12|All participants. n=number of participants with evaluable data at given time-points.||mg/dL||Standard Deviation|Mean
813937|NCT01083186|Secondary|Change From Enrollment in Triglyceride Levels at Months 6 and 12|The normal range for triglycerides was 0-200 mg/dL.|Enrollment, Month 6, Month 12|All participants. n=number of participants with evaluable data at given time-points.||mg/dL||Standard Deviation|Mean
813938|NCT01083186|Secondary|Change From Enrollment in Total Cholesterol Levels at Months 6 and 12|The total cholesterol normal range was 130-200 mg/dL.|Enrollment, Month 6, Month 12|All participants. n=number of participants with evaluable data at given time-points.||mg/dL||Standard Deviation|Mean
813939|NCT01083186|Secondary|Change From Baseline in Alkaline Phosphatase (ALP) Levels at Months 6 and 12|The alkaline phosphatase normal range was 40-129 IU/L.|Baseline, Month 6, Month 12|All participants. n=number of participants with evaluable data at given time-points.||IU/L||Standard Deviation|Mean
813940|NCT01083186|Secondary|Change From Baseline in Urea Levels at Months 6 and 12|The urea normal range was 10-50 mg/dL.|Baseline, Month 6, Month 12|All participants. n=number of participants with evaluable data at given time-points.||mg/dL||Standard Deviation|Mean
813941|NCT01083186|Secondary|Change From Baseline in Creatinine Levels at Months 6 and 12|The creatinine normal range was 0.6-1.4 mg/dL.|Baseline, Month 6, Month 12|All participants. n=number of participants with evaluable data at given time-points.||mg/dL||Standard Deviation|Mean
813942|NCT01083186|Secondary|Change From Baseline in Aspartate Aminotransferase (AST) Levels at Months 6 and 12|The aspartate aminotransferase normal range was 11-38 IU/L.|Baseline, Month 6, Month 12|All participants. n=number of participants with evaluable data at given time-points.||IU/L||Standard Deviation|Mean
813943|NCT01083186|Secondary|Change From Baseline in Alanine Aminotransferase (ALT) Levels at Months 6 and 12|The alanine aminotransferase normal range was 11-43 IU/L.|Baseline, Month 6, Month 12|All participants. n=number of participants with evaluable data at given time-points.||IU/L||Standard Deviation|Mean
813944|NCT01083186|Secondary|Estimated Glomerular Filtration Rate (eGFR) Values Throughout the Study|The eGFR normal range was 90-120 mL/min/1.73m^2.|Baseline, Enrollment Visit, Month 3, Month 6, Month 9, Month 12|All participants. n=number of participants with evaluable data at given time-points.||mL/min/1.73m^2||Standard Deviation|Mean
813945|NCT01083186|Secondary|Distribution of Participants by Chronic Kidney Disease (CKD) Stage Throughout Study|Change in CKD stage throughout the study period was assessed by the estimated glomerular filtration rate (eGFR) levels recorded by the physicians at each study time point. Classification of eGFR into CKD stages as follows: CKD stage 2: 60-89 mL/min/1.73m^2; CKD stage 3: 30-59 mL/min/1.73m^2; CKD stage 4: 15-29 mL/min/1.73m^2; CKD stage 5: <15 mL/min/1.73/m^2. Table presents the number of participants by stage at each study visit.|Baseline, Enrollment Visit, Month 3, Month 6, Month 9, Month 12|All participants. n=number of participants with evaluable data at given time-points.||participants|||Number
813946|NCT01083186|Secondary|Non-serious Adverse Events (nSAEs) and Serious Adverse Events (SAEs)|In order to establish the safety profile of oral paricalcitol in daily clinical practice, non-serious adverse events (nSAEs) and serious adverse events (SAEs) were collected during the course of the study. An adverse event (AE) is defined as any untoward medical occurrence in a patient, which does not necessarily have a causal relationship with their treatment. If an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE): results in death or is life-threatening, results in admission or prolongation of hospitalization, is a congenital anomaly or persistent or significant disability/incapacity or is an important medical event requiring medical or surgical intervention to prevent any of the outcomes listed above. Please see Adverse Events section below for more details.|From time of enrollment throughout the study up to 12 months for nSAEs. SAEs from time of enrollment throughout the study up to + 30 days after end of study.|All participants||participants|||Number
813949|NCT01083186|Secondary|Change in Dipstick Albuminuria Grade From Baseline to Month 6|The values “-, Trace, +, ++, and +++” are taken directly from the dipstick measurements, and represent a range from none to highest albuminuria. Data presented shows the number of participants with each value both at Baseline and at Month 6.|Baseline, Month 6|Number of participants with evaluable data at both Baseline and Visit 3 (6 Months Post-Enrollment)||participants|||Number
813950|NCT01083186|Secondary|Number of Participants With Serum Phosphorus Level Abnormalities|Normal serum phosphorus range was 2.7-4.6 mg/dL.|Baseline, Enrollment Visit, Month 6, Month 12|All participants. n=number of participants with evaluable data at given time-point||participants|||Number
813951|NCT01083186|Secondary|Number of Participants With Serum Calcium Level Abnormalities|Normal serum calcium range was 8.4-10.2 mg/dL.|Baseline, Enrollment Visit, Month 6, Month 12|All participants. n=number of participants with evaluable data at given time-point.||participants|||Number
813952|NCT01083186|Secondary|Distribution of Participants by Achievement of Intact Parathormone (iPTH) Levels Within the Target Range|Number of participants with iPTH levels within the target range of Kidney Disease Quality Outcome Initiative (K/DOQI) treatment guidelines at each study measurement after oral paricalcitol treatment onset. K/DOQI treatment guidelines: CKD Stage 3: 35–70 pg/mL; CKD Stage 4: 70–110 pg/mL during a 12-month period of treatment with oral paricalcitol.|Enrollment Visit, Month 3, Month 6, Month 9, Month 12|All participants. n=participants with evaluable data at given time point.||participants|||Number
813953|NCT01083186|Secondary|Mean Duration of Effect Sustainability (Months)|The effect was considered sustainable if: the participant’s intact parathormone (iPTH) value remained equal or lower to the upper limit of the target range according to Kidney Disease Quality Outcome Initiative (K/DOQI) guidelines (CKD Stage 3: ≤ 70 pg/mL; CKD Stage 4: ≤ 110 pg/mL); or iPTH levels continued to decrease 30% from the previous available measurement.|Measured from start of study, up to a maximum of 12 months|All evaluable participants||months||Standard Deviation|Mean
813954|NCT01083186|Secondary|Median Time to Attain the First Lower Intact Parathormone (iPTH) Levels|The time to attain the first lower iPTH levels was considered as the time from the date of oral paricalcitol treatment onset until the date when any of the following conditions were initially met: a 30% reduction from iPTH levels prior to treatment onset had been achieved, for patients who were still outside the target range; or iPTH levels equal or lower to the upper limit of the target range according to Kidney Disease Quality Outcome Initiative (K/DOQI) guidelines (CKD Stage 3: ≤ 70 pg/mL; CKD Stage 4: ≤ 110 pg/mL; CKD Stage 5: ≤ 300 pg/mL).|Measured from start of study, up to a maximum of 12 months|Subset of participants with baseline CKD stage ≥ 3 as well as with available iPTH values greater than the upper limit of the target range, prior to paricalcitol treatment onset. Target range for this specific analysis was defined based on patient’s CKD stage (per baseline eGFR) prior to paricalcitol treatment onset.||months||95% Confidence Interval|Median
813955|NCT01083186|Primary|Intact Parathormone (iPTH) Changes During the Study Time-Points for Subpopulation of Renal Transplanted Participants|iPTH levels before and after oral paricalcitol treatment onset were recorded at each study visit, and corresponding changes were calculated for the subpopulation of renal transplanted participants.|Baseline, Enrollment Visit, Month 3, Month 6, Month 9, Month 12|Participants with renal transplantation history. n=number of participants with available data at given time-point.||pg/mL||Standard Deviation|Mean
813956|NCT01083186|Primary|Intact Parathormone (iPTH) Changes During the Study Time-Points for Overall Study Population|iPTH levels before and after oral paricalcitol treatment onset were recorded at each study visit, and corresponding changes were calculated for the overall study population.|Baseline, Enrollment Visit, Month 3, Month 6, Month 9, Month 12|Overall study population. n=number of participants with available data at given time-point.||pg/mL||Standard Deviation|Mean
813957|NCT01083199|Secondary|Bladder Neck Contracture (BNC) Rate||Subjects that develop BNC between the scheduled follow-up visits at 6 weeks, 6 and 12 months post-device removal||||||
813958|NCT01083199|Secondary|Incontinence Rate and I-QOL Score||Baseline, 6-week, 6 and 12-month evaluations||||||
813959|NCT01083199|Secondary|Percentage of Subjects Demonstrating Functionally Adequate Anastomosis at the 1st and 2nd Device Removal Visits||7 and 14 days post-Device placement||||||
813960|NCT01083199|Secondary|Intraoperative/Postoperative Parameters||At Device placement||||||
813961|NCT01083199|Primary|Functionally Adequate Vesico-urethral Anastomosis Within 21 Days Post-procedure in Subjects With Successful Device Placement|"Device removal was first attempted at the 7-day window; if extravasation was noted, the subject returned for a second attempt at the 14-day window. If extravasation was noted at the first and second attempts, the subject could then return for a 3rd and final removal at the 21-day window.
The following defines the timeframe of each removal attempt:
7-day window (7-10 days post-implant)
14-day window (13-15 days post-implant)
21-day window (19-21 days post-implant)"|7-21 days post-Device placement|||participants with device removal by 21d|||Number
813962|NCT01083199|Primary|Successful Device Placement|Successful Device placement was defined as the establishment of a water-tight anastomosis immediately post-Device placement.|During Radical Prostatectomy|||participants|||Number
813963|NCT01083316|Secondary|Number of Participants Surviving at 5 Years||5 years||12/2018||||
813964|NCT01083316|Primary|Number of Participants Proceeding to Transplant Following Induction||2 months|||Participants|||Count of Participants
813965|NCT01083316|Primary|Number of Participants Surviving at 100 Days Post Transplant||100 days|||Participants|||Count of Participants
813966|NCT01083316|Primary|Number of Participants With Disease Response|Complete response: Normal serum free light chain ratio and Negative serum and urine immunofixation electrophoresis Very good partial response: Difference in serum free light chains less than 40 mg/L Partial Response: >50% Reduction in the difference in serum free light chains|One year|||Participants|||Count of Participants
813967|NCT01083472|Primary|Hernia Occurrence|Hernia occurrence will be assessed by clinical evaluation. At Month 12 and at any time during the study if hernia occurrence is clinically suspected, a magnetic resonance image (MRI) will be obtained.|Month 12 after repair|Due to early termination of the study and the low enrollment number (only 37 subjects out of the planned 200 subjects being enrolled), all planned analyses of study endpoints were not performed. The only study results obtained focused on safety. Due to the small sample size these safety results should be interpreted with caution.|||||
814970|NCT01092663|Primary|Hemoglobin A1C|Change from baseline in hemoglobin A1C after 12 weeks of colesevelam or colesevelam plus sitagliptin treatments|Baseline and 12 weeks|||percentage||Standard Deviation|Mean
813968|NCT01083485|Secondary|Mean Dose (mg) of Rescue Analgesia for the Treatment Phase for Subjects Taking 20/10mg OXN PR Tablets or 20mg OXY PR Tablets|To compare the use of rescue analgesia for the 2 groups (OXN 20/10mg tablets and OXY 20mg tablets) during the double blind treatment phase. Rescue medication was given (OXY Immediate Release, 5mg capsules) if the subjects pain score on the (Numeric Rating Scale (NRS), 0 (no pain) to 10 (worst possible pain)), was greater than or equal to 4. The value presented is the mean dose over the double blind phase.|Mean dose during the whole double blind treatment phase (2.5 days)|This is the per protocol population (PP), which is a subset of the full analysis population. The data presented is only for those subjects taking the higher dose (20/10 mg OXN or 20 mg OXY) in the study.||mg of rescue analgesia||Standard Deviation|Mean
813969|NCT01083485|Primary|Mean of 4 NRS Scores for 24 Hour Pain Intensity at Rest, Shown as Absolute Change From Baseline (i.e. a Decrease From the Baseline Value)|"The primary efficacy variable was the 24hr pain intensity score at rest, on a Numerical Rating Scale (NRS), with 0 = no pain and 10 = worst possible pain. This was assessed 1 hour after dosing on Day 1 (evening only), Day 2(morning and evening) and Day 3 (morning only). The primary efficacy end point (absolute change from baseline) was analysed on the per protocol (PP) data. The mean of these scores is shown as a value that is a mean change (a decrease in pain score) from the baseline value."|Mean of 24 hour pain intensity (absolute change from baseline)|The primary efficacy end point (absolute change from baseline) was analysed on the PP data using a mixed model repeated measures of analysis of covariance (RMANCOVA).||Units on a scale||95% Confidence Interval|Mean
813970|NCT01083576|Secondary|Pharmacokinetic Parameter: AUC/D|Area under the plasma concentration-time curve over 24 hrs divided by topical dose (AUC/D) of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama|Days 1 and 20|Adults ages >= 17 years with measurable samples.||hr/ML||Standard Deviation|Mean
813971|NCT01083576|Secondary|Pharmacokinetic Parameter: Cmax/D|Maximum observed plasma concentration divide by topical dose (Cmax/D) of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama|0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20|Adults ages >= 17 years with measurable samples.||1/ML||Standard Deviation|Mean
813972|NCT01083576|Secondary|Pharmacokinetic Parameter: t(1/2)|t(1/2) of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama|0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20|Adults ages >= 17 years with measurable samples. Paromomycin Alone Treatment had only 5 measureable samples on Day 1, and WR 279,396 had only 4 measureable samples on Day 20.||hr||Standard Deviation|Mean
813973|NCT01083576|Other Pre-specified|Serum Creatinine Levels|Blood creatinine was measured to assess possible nephrotoxicity associated with aminoglycosides|Day 1 and Day 20|All randomized subjects were included in the mITT Analysis. All subjects met criteria for the evaluable subset.||mg/dL||Standard Deviation|Mean
813974|NCT01083576|Secondary|Pharmacokinetic Parameter: Area Under the Curve (AUC)|Area under the curve (AUC) of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama|0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20|Adults ages >= 17 years with measurable samples.||ng*hr/mL||Standard Deviation|Mean
813975|NCT01083576|Secondary|Pharmacokinetic Parameter: Tmax|Tmax of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama|0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20|Adults ages >= 17 years with measurable samples. Both groups had only 6 measureable samples each on Day 1.||hr||Standard Deviation|Mean
813976|NCT01083576|Secondary|Pharmacokinetic Parameter: Cmax|Cmax of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama|0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20|Adults with measurable samples.||ng/mL||Standard Deviation|Mean
813977|NCT01083576|Secondary|Paromomycin Plasma Concentrations in Children|Paromomycin plasma concentrations 4 hours following administration of paromomycin alone or WR 279,396 in children|Days 1 and 20|Children ages 7 to 16||ng/mL||Standard Deviation|Mean
813978|NCT01083576|Secondary|Paromomycin Plasma Concentrations in Adults|Paromomycin plasma concentrations following administration of paromomycin alone or WR 279,396 in adults|Day 4 to Day 28|Adults ages >= 17 years||ng/mL||Standard Deviation|Mean
813979|NCT01083576|Secondary|Detectable Paromomycin or Gentamicin Plasma Levels|Proportion of subjects with any detectable Paromomycin or Gentamicin plasma levels on a study day when blood for PK was collected|20 days|Adults ages >= 17 years||Participants|||Number
813980|NCT01083576|Secondary|Number of Participants Who Obtained a Modified Final Clinical Cure of All Lesions|Final cure as defined by the primary outcome measure AND and cure of all other lesions by Day 168. (100% re-epithelialization of all ulcerated lesions and resolution of all other type of lesions)|168 days|All randomized subjects were included in the mITT Analysis. All subjects met criteria for the evaluable subset.||Participants|||Number
813981|NCT01083576|Primary|Number of Participants Who Obtained Final Clinical Cure of Index Lesion|Number of participants who had initial clinical cure (100% re-epithelialization of index lesion by Day 63) OR initial clinical improvements (> 50% re-epithelialization of index lesion followed by Day 63 by 100% re-epithelialization of the index lesion on or before Day 100), AND no relapse of index lesion.|168 days|All randomized subjects were included in the mITT Analysis. All subjects met criteria for the evaluable subset.||Participants|||Number
813982|NCT01083602|Secondary|Over All Survival|Kaplan Meier estimates- median time to event|24 weeks|FAS||Days||95% Confidence Interval|Median
813983|NCT01083602|Secondary|Time to Progression|Time from randomization until objective tumor progression; does not include deaths-- Kaplan-Meier estimates|24 weeks|FAS||Days||95% Confidence Interval|Median
813984|NCT01083602|Secondary|Progression-free Survival|Progression-free survival (PFS) was defined as the time from the date of first study treatment to first occurrence of documented progressive disease /relapse or death. Time from randomization until disease progression or death by Kaplan-Meier estimates|24 weeks|Full Analysis Set (FAS)||days||95% Confidence Interval|Median
813985|NCT01083602|Secondary|Time to Response (Greater Than or Equal to PR) Based on Investigator Assessment|Time to response is defined as the time from the date of first administration of study treatment to the date of first documented evidence of CR or nCR or PR (whichever status is recorded first). Patients who do not have a response of PR or better by the data cut-off date are censored.|after eight cycyles of treatment (24 weeks)|FAS||Days||Standard Deviation|Mean
824834|NCT01178268|Secondary|Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI||24 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
813987|NCT01083602|Primary|Overall Response Rate (PR+nCR+CR)|Overall response rate=(PR+nCR+CR) CR= < 5% plasma cells in bone marrow. No confirmation on bone marrow plasma cell (additional assessment) is needed to document CR except patients with non-secretory myeloma where the bone marrow examination must be repeated after an interval of at least 6 weeks, Absence of M-protein in serum and urine by immunofixation,nCR same as CR without out Absence of M-protein in serum and urine by immunofixation,PR+ 50% reduction of serum M-protein and sofft tissue Plasmacytomas all for more than 6 weeks.|after eight cycyles of treatment (24 weeks)|Full Analysis Set||percentage of participants||95% Confidence Interval|Number
813988|NCT01083641|Secondary|Median Overall Survival (OS)||Up to 4 years|||months||95% Confidence Interval|Median
813989|NCT01083641|Secondary|Progression-free Survival (PFS)||Up to 4 years|||months||95% Confidence Interval|Median
813990|NCT01083641|Secondary|Clinical Benefit (CB)|Defined as complete response, partial response, or stable disease at > 16 weeks|Up to 4 years|||Participants|||Count of Participants
813991|NCT01083641|Primary|Determine Tumor Objective Response (OR) Rates|OR=complete response (CR) + partial response (PR) as defined by RECIST version 1.1, where CR=disappearance of all target lesions, and PR=At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|Up to 4 years|||percentage of participants||95% Confidence Interval|Number
813992|NCT01083654|Primary|7-day Point-prevalence Smoking Abstinence|Self-reported abstinence (versus smoking) during the past 7 days at the 6-month follow-up time-point, verified by exhaled breath carbon monoxide (CO) measurement (< 10 parts per million CO is indicative of no smoking).|6 months|||Number of abstinent participants|||Number
813993|NCT01083667|Secondary|Appel ALS Score|an objective and timed measurement of strength and function of subjects including muscle testing, respiratory function and fine motor function, all summed together for a total value, and is measured at baseline, visit 2, visit 6 and end of study. The scale ranges from 30 in a healthy person to to 164 in a maximally impaired person; an increase in score indicates progression and is expected in disease progression.|Week 0, 6, 18, and end of study|22 subjects completed to visit 9 and had a final score for Appel Score. Reported is the mean change from Baseline to week 36||units on a scale||95% Confidence Interval|Number
813994|NCT01083667|Primary|Mean Change in SOD1 CSF|Reported change in mean SOD1 CSf from baseline to visit 6 (week 18) and end of study for all subjects who completed the measure|baseline, Visit 6 week 18, end of study|24 subjects completed up to visit 6 and 21 subjects for final study visit. Reported is the change in SOD1 CSF from baseline to week 36.||ng/ml||95% Confidence Interval|Mean
813995|NCT01083680|Secondary|Compliance With the Self-injection Via the Humira®-PEN|Adalimumab will be self-administered by participants using Humira®-PEN. Analysis of compliance was not performed as outlined in the protocol.|Months 0, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60|Compliance data were not collected.|||||
813996|NCT01083680|Secondary|4.Mean Harvey Bradshaw Index (HBI) in Full Analysis Set (FAS) Participants Over Time|The HBI is a simplified version of the CDAI; HBI scores correlate well with CDAI scores. The HBI consists of 5 items encompassing patient-reported (well-being, symptoms)and objective (presence of abdominal mass or complications) variables. Symptom scores are based on symptom status on the previous day rather than the total of 7 days as for the CDAI. The total HBI score is the sum of the values for each of the five items. Higher HBI scores indicate greater disease activity; 0 would the lower limit with no set upper limit. Scores < 5 indicate remission, 5 – 7 indicate mild disease, 8 – 16 indicate moderate disease, and 16 indicate severe disease. Each HBI unit is equivalent to approximately 27 CDAI units. Higher scores indicate greater disease activity.|Months 0, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60|Effectiveness analyses included all participants with evaluable data.||units on a scale||Standard Deviation|Mean
813997|NCT01083680|Primary|Percentage of Participants With Adverse Events (Excluding Serious Adverse Events)|"An adverse event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with their treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not the event is considered causally related to the use of the product.
For more details on adverse events please see the AE section below."|Months 0, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60|Analysis included safety analysis population with incidence of greater than 1% during the study.||percentage of participants|||Number
813998|NCT01083680|Primary|Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at Each Visit in FAS Participants|The Short Inflammatory Bowel Disease Questionnaire (SIBDQ) is an abbreviated version of the Inflammatory Bowel Disease (IBD) Questionnaire, a Health-related quality of life (HRQOL) assessment tool for patients with IBD. The SIBDQ utilizes 10 items concerning patient well-being during the last 2 weeks, each of which is scored on a scale of 1 (poor HRQOL) to 7 (optimum HRQOL). The individual sub scores are added to produce the total SIBDQ score. SIBDQ scores range from 10 to 70 with higher values indicating better HRQOL. Positive changes indicate reductions in disease activity.|Months 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60|Effectiveness analyses included all participants with evaluable data.||units on a scale||Standard Deviation|Mean
813999|NCT01083680|Primary|Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time|The CDAI is a measure of clinical response and remission that was developed for use in clinical trials. The CDAI includes 8 variables encompassing both participant-reported (symptoms, general well-being) and objective (medication usage, laboratory variables, presence of abdominal mass or complications, and weight) variables. For symptoms scores, patients keep track of daily symptoms on a diary card, and the daily symptom scores are summed for the week. Each item in the CDAI is assigned a specific weight, and the weighted values of the items are totaled to produce the CDAI score. Higher CDAI scores indicate greater disease activity; there is no set upper limit. The scale for the scores is as follows: < 150 to indicate remission, 150 - 219 to define mildly active disease, 220 - 450 to define moderately active disease, and > 450 to define severely active disease.|Months 0, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60|Effectiveness analyses included all participants with evaluable data.||percentage of participants|||Number
814033|NCT01083758|Secondary|Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient’s Global Assessment of Disease Severity at Weeks 2, 4, 8, and End of Treatment.|Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient’s Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation.|week 8|||% of participants w/ controlled disease|||Number
814000|NCT01083680|Primary|Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) at Each Visit|The CDAI is a measure of clinical response and remission that was developed for use in clinical trials. The CDAI includes 8 variables encompassing both patient-reported (symptoms, general well-being) and objective (medication usage, laboratory variables, presence of abdominal mass or complications, and weight) variables. For symptoms scores, patients keep track of daily symptoms on a diary card, and the daily symptom scores are summed for the week. Each item in the CDAI is assigned a specific weight, and the weighted values of the items are totaled to produce the CDAI score. Higher CDAI scores indicate greater disease activity; 0 would the lower limit with no set upper limit. The scale for the scores is as follows: < 150 to indicate remission, 150 – 219 to define mildly active disease, 220 – 450 to define moderately active disease, and > 450 to define severely active disease. Negative changes indicate reductions (improvement) in disease activity.|Months 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60|Effectiveness analyses included all participants with evaluable data.||units on a scale||Standard Deviation|Mean
814001|NCT01083693|Secondary|C-Reactive Protein|The test for C-Reactive Protein (CRP) is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, months 3,6,9,12|Mean (average) value is based on the number of participants included in the analysis (N =161) who completed the lab assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination [for participants who discontinued the study early]) in each disease group.||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
814002|NCT01083693|Secondary|Erythrocyte Sedimentation Rate|Erythrocyte sedimentation rate (ESR) is a nonspecific lab value that measures inflammation from arthritic disease. A decrease in the level indicates reduction in inflammation and therefore improvement.|Baseline, months 3,6,9,12|Mean (average) value is based on the number of participants included in the analysis (N=161) who completed the lab assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination [for participants who discontinued the study early]) in each disease group.||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
814003|NCT01083693|Secondary|Physician´s / Patient's Global Assessment of State of Health (GH) Measured on a Visual Analogue Scale, for RA and PsA Patients Only|Physician's and Patient's Global Assessment of State of Health was measured using a visual analogue scale with scores from 0 to 100 (higher scores indicate worse health state).|Baseline, months 3,6,9,12|Mean (average) score is based on the number of participants included in the analysis (N =121) who completed the assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination [for participants who discontinued the study early]) in each disease group.||Units on a scale||Standard Deviation|Mean
814004|NCT01083693|Secondary|Physician´s /Patient's Global Assessment on Disease Activity Measured on a Visual Analogue Scale, for RA and PsA Patients Only|Physician's and Patient's Global Assessment of Disease Activity (PGA) are measured using a visual analogue scale with scores ranging from 0 to 100 (higher scores indicate worse disease activity).|Baseline, months 3,6,9,12|Mean (average) score is based on the number of participants included in the analysis (N=121) who completed the assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination [for participants who discontinued the study early]) in each disease group.||Units on a scale||Standard Deviation|Mean
814005|NCT01083693|Secondary|Changes in Bath Ankylosing Spondylitis Disease Activity Index in Patients With AS: Measures Patients Fatigue, Pain (Neck, Hip, Other Joints), Tender Sensitive Body Sites, Morning Stiffness|Bath as Disease Activity Index (BASDI) measures fatigue, pain (neck, hip, other joints), tender sensitive body sites, and morning stiffness for patients suffering from AS. Scores range from 0 to 10 with higher scores representing worse disease activity.|Baseline, months 3,6,9,12|Mean (average) score is based on the number of participants included in the analysis (N=40) who completed the assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination [for participants who discontinued the study early]).||Units on a scale||Standard Deviation|Mean
814006|NCT01083693|Secondary|DAS28: Changes in Disease Activity Score 28 in Patients With RA and if Reasonable in PsA: Measures the no. of Swollen and Tender Joints (28 Joints), Erythrocyte Sedimentation Rate, Patients Global Assessment of Disease Activity on a Visual Scale|The Disease Activity Score 28 measures disease activity based on the number of swollen and tender joints (28 joints), erythrocyte sedimentation rate, and patient's global assessment of disease activity on a visual scale. DAS28 is a unit scale from 0 (best value) to 10.0 (worst value).|Baseline,months 3,6,9,12|Mean (average) score is based on the number of participants included in the analysis (N=121) who completed the assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination [for participants who discontinued the study early]) in each disease group.||Units on a scale||Standard Deviation|Mean
814007|NCT01083693|Primary|EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression|"European Quality of Life 5 Dimensions (EQ-5D) is a self-reported health outcome which measures mobility, self care, usual activities, pain discomfort, anxiety depression. An overall score is derived that measures from -0.59 (worst) to +1 (best).
In addition, health state is measured on the thermometer scale (score 0 to 100) with higher scores representing better health status."|Baseline, months 3,6,9,12|Mean (average) score is based on the number of participants included in the analysis (N=161) who completed the assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination [for participants who discontinued the study early]) in each disease group.||Units on a scale||Standard Deviation|Mean
814008|NCT01083693|Primary|SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain|Medical Outcomes Study Short Form 36 (MOS SF-36) is generic assessment of health status that consists of 36 questions within 8 domains including Physical Functioning (PF), Role Functioning - Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role Functioning - Emotional (RE), Mental Health (MH) and Reported Health Transition (HT). Results from each domain are summarized and transformed into a scale ranging from 0 (worst) to 100 (best) with the exception of HT. The score range for HT is 0 (worst) to 5 (best).|Baseline, months 3,6,9,12|Mean (average) score is based on the number of participants included in the analysis (N=161) who completed the assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination [participants who discontinued the study early]) in each disease group. No participants in the PsA or the AS group attended an early termination visit.||Units on a scale||Standard Deviation|Mean
814009|NCT01083693|Primary|RA and if Reasonable for PsA Patients Health Assessment Questionnaire Disability Index HAQ-DI|The HAQ-DI is a questionnaire that measures functional status (disability) and health-related quality of life. It measures a patient's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene,reach, grip, activities. Each question is evaluated according to the degree of severity on a scale ranging from 0 (without any difficulty) to 3 (unable to do).|Baseline, months 3,6,9,12|Mean (average) score is based on the number of participants included in the analysis (N =121) who completed the assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination [for participants who discontinued the study early]) in each disease group.||Units on a scale||Standard Deviation|Mean
814010|NCT01083706|Secondary|Incidence of Grades II-IV Graft-versus-host Disease (GVHD)||6 months|||Participants|||Count of Participants
814011|NCT01083706|Secondary|Rate of Response by IWG Criteria|Count of participants achieving a complete or partial remission at 6 months.|6 months|||Participants|||Count of Participants
814012|NCT01083706|Primary|Overall Survival|Count of surviving participants at 6 months.|6 months|||Participants|||Count of Participants
814013|NCT01083732|Secondary|Global Assessment of Tolerability of Study Medication|The investigator was to provide a global clinical assessment of tolerability of study medication by the patient.This assessment was based on 5-point scale (good, satisfactory, not satisfactory, bad, not assessable).|Day 1 (immediately after dosing)|Treated set||Percentage of participants|||Number
814014|NCT01083732|Secondary|Percentage of Patients With Changes in Laboratory and Clinical Parameters Such as Liver Enzymes and Physical Examination|"Percentage of patients with changes in laboratory and clinical parameters such as liver enzymes and physical examination.
Clinically Relevant Abnormalities for Laboratory Parameters were reported."|During the treatment period, Up to 6 days|Treated set||Percentage of participants|||Number
814015|NCT01083732|Secondary|Global Assessment of Tolerability of Study Medication- Taste Assessment|The investigator was to provide a global clinical assessment of tolerability including patient taste assessment.This assessment was based on 6-point scale (Very good, good, satisfactory, bad, very bad, missing). The taste assessment was only provided when the patient was old enough to evaluate the taste.|Day 1 (immediately after dosing)|Treated set||Percentage of participants|||Number
814016|NCT01083732|Secondary|Percentage of Patients With Any Adverse Events During the Treatment Period|Percentage of patients with any adverse events during the treatment period. For patients with multiple dosing, all AEs with an onset date after the date of first dose until the end of trial treatment including 3 days after the last treatment were assigned to the on-treatment period. For patients with single dosing, all AEs with an onset during the 48-h-period after study medication intake were assigned to the on-treatment period.|Up to 6 days|Treated set||Percentage of participants|||Number
814017|NCT01083732|Primary|Percentage of Patients With Incidence of Any Bleeding Events (Major, Clinically Relevant Non-major (CRNM) and Minor) During the Treatment Period.|Major: Fatal bleeding, Clinically overt bleeding associated with decrease in haemoglobin of at least 2 g/dL in 24-h-period,bleeding that was retroperitoneal,pulmonary,intracranial,or otherwise involved the central nervous system,bleeding that required surgical intervention in an operating suite. CRNM: Overt bleeding for which a blood product was administered & which was not directly attributable to the patient’s underlying medical condition,bleeding that required medical or surgical intervention to restore haemostasis,other than in an operating suite. Minor: Any overt or macroscopic evidence of bleeding that did not fulfil the criteria for either major bleeding or CRNM bleeding. For multiple dosing,all events with an onset date after the date of first dose until the end of trial treatment including 3 days after the last treatment and for single dosing,all events with an onset during the 48-h-period after study medication intake were assigned to the on-treatment period.|Up to 6 days|Treated set||Percentage of participants|||Number
814018|NCT01083732|Primary|AUC0-tz (Area Under the Concentration Time Curve of the Free Dabigatran in Plasma Over the Time Interval 0 up to the Last Quantifiable Data Point)|"AUC0-tz (area under the concentration time curve of the free dabigatran in plasma over the time interval 0 up to the last quantifiable data point).
Endpoint can only be calculated for single dose patients. For multiple dose patients the time points do not allow calculation of AUC0-tz (no profile, only one measurement after selected doses, refer to primary outcome no. 1 and 2)."|At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate|Pharmacokinetic set (PKS): This patient set included all treated patients who provided at least one pharmacokinetic/ pharmacodynamic (PK/PD) observation and had no important protocol violations (PVs) with respect to the statistical analysis of PK or PD endpoints.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
814019|NCT01083732|Primary|Tmax (Time From Dosing to Maximum Measured Concentration of Free Dabigatran in Plasma)|"tmax (time from dosing to maximum measured concentration of free dabigatran in plasma).
Endpoint can only be calculated for single dose patients. For multiple dose patients the time points do not allow calculation of tmax (no profile, only one measurement after selected doses, refer to primary outcome no. 1 and 2)."|At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate|Pharmacokinetic set (PKS): This patient set included all treated patients who provided at least one pharmacokinetic/ pharmacodynamic (PK/PD) observation and had no important protocol violations (PVs) with respect to the statistical analysis of PK or PD endpoints.||hours||Full Range|Median
814020|NCT01083732|Primary|Cmax (Maximum Measured Concentration of Free Dabigatran in Plasma)|Cmax (maximum measured concentration of free dabigatran in plasma). Endpoint can only be calculated for single dose patients. For multiple dose patients the time points do not allow calculation of Cmax (no profile, only one measurement after selected doses, refer to primary outcome no. 1 and 2).|At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate|Pharmacokinetic set (PKS): This patient set included all treated patients who provided at least one pharmacokinetic/ pharmacodynamic (PK/PD) observation and had no important protocol violations (PVs) with respect to the statistical analysis of PK or PD endpoints.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
814034|NCT01083758|Secondary|Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient’s Global Assessment of Disease Severity at Weeks 2, 4, 8, and End of Treatment.|Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient’s Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation.|week 4|||% of participants w/ controlled disease|||Number
814021|NCT01083732|Primary|AUC0-tz (Area Under the Concentration Time Curve of the Total Dabigatran in Plasma Over the Time Interval 0 up to the Last Quantifiable Data Point)|"AUC0-tz (area under the concentration time curve of the total dabigatran in plasma over the time interval 0 up to the last quantifiable data point).
Endpoint can only be calculated for single dose patients. For multiple dose patients the time points do not allow calculation of AUC0-tz (no profile, only one measurement after selected doses, refer to primary outcome no. 1 and 2)."|At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate|Pharmacokinetic set (PKS): This patient set included all treated patients who provided at least one pharmacokinetic/ pharmacodynamic (PK/PD) observation and had no important protocol violations (PVs) with respect to the statistical analysis of PK or PD endpoints.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
814022|NCT01083732|Primary|Tmax (Time From Dosing to Maximum Measured Concentration of Total Dabigatran in Plasma)|"tmax (time from dosing to maximum measured concentration of total dabigatran in plasma).
Endpoint can only be calculated for single dose patients. For multiple dose patients the time points do not allow calculation of tmax (no profile, only one measurement after selected doses, refer to primary outcome no. 1 and 2)."|At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate|Pharmacokinetic set (PKS): This patient set included all treated patients who provided at least one pharmacokinetic/ pharmacodynamic (PK/PD) observation and had no important protocol violations (PVs) with respect to the statistical analysis of PK or PD endpoints.||hours||Full Range|Median
814023|NCT01083732|Primary|Cmax (Maximum Measured Concentration of Total Dabigatran in Plasma)|Cmax (maximum measured concentration of total dabigatran in plasma). Endpoint can only be calculated for single dose patients. For multiple dose patients the time points do not allow calculation of Cmax (no profile, only one measurement after selected doses, refer to primary outcome no. 1 and 2).|At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate|Pharmacokinetic set (PKS): This patient set included all treated patients who provided at least one pharmacokinetic/ pharmacodynamic (PK/PD) observation and had no important protocol violations (PVs) with respect to the statistical analysis of PK or PD endpoints.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
814024|NCT01083732|Primary|Central Measurement of Diluted Thrombin Time (dTT) at Predose and 2 and 10 h After Intake of Study Medication.|Central measurement of dTT (diluted thrombin time) at predose and 2 and 10 h after intake of study medication. The Standard Deviation presented below are actually the % coefficient of variation|at predose and 2 and 10 h after intake of study medication.|PKS (evaluable cases)||seconds||Standard Deviation|Mean
814025|NCT01083732|Primary|Central Measurement of Ecarin Clotting Time (ECT) at Predose and 2 and 10 h After Intake of Study Medication.|Central measurement of ECT (ecarin clotting time) at predose and 2 and 10 h after intake of study medication. ECT was not planned to be measured in the multiple dose group. The Standard Deviation presented below are actually the % coefficient of variation|at predose and 2 and 10 h after intake of study medication.|PKS (evaluable cases)||seconds||Standard Deviation|Mean
814026|NCT01083732|Primary|Central Measurement of Activated Partial Thromboplastin Time (aPTT) at Predose and 2 and 10 h After Intake of Study Medication.|Central measurement of aPTT (activated partial thromboplastin time) at predose and 2 and 10 h after intake of study medication. For multiple dose patients only local measurements were planned. The Standard Deviation presented below is actually the % coefficient of variation.|at predose and 2 and 10 h after intake of study medication.|Pharmacokinetic set (PKS): This patient set included all treated patients who provided at least one pharmacokinetic/ pharmacodynamic (PK/PD) observation and had no important protocol violations (PVs) with respect to the statistical analysis of PK or PD endpoints.||seconds||Standard Deviation|Mean
814027|NCT01083732|Primary|Plasma Concentration of Metabolite BIBR 1087 SE|Plasma concentration of metabolite BIBR 1087 SE|At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate and at 2 h, 50 h, and 72 h after multiple dose administration of dabigatran etexilate|Pharmacokinetic set (PKS): This patient set included all treated patients who provided at least one pharmacokinetic/ pharmacodynamic (PK/PD) observation and had no important protocol violations (PVs) with respect to the statistical analysis of PK or PD endpoints.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
814028|NCT01083732|Primary|Plasma Concentration of Metabolite BIBR 951 BS|Plasma concentration of metabolite BIBR 951 BS|At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate and at 2 h, 50 h, and 72 h after multiple dose administration of dabigatran etexilate|PKS (evaluable cases)||ng/mL||Geometric Coefficient of Variation|Geometric Mean
814029|NCT01083732|Primary|Plasma Concentration of Unchanged Dabigatran Etexilate (BIBR 1048 BS)|"Plasma concentration of unchanged dabigatran etexilate (BIBR 1048 BS).
Some values are NA because Values were below the limit of quantification. Not calculated as reliable estimation can only be performed when at least 2/3 of the data are available and thus the Geometric Mean (gMean) and Geometric Coefficient of Variation (gCV) is not calculated according to internal rules."|At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate and at 2 h, 50 h, and 72 h after multiple dose administration of dabigatran etexilate|PKS (evaluable cases)||ng/mL||Geometric Coefficient of Variation|Geometric Mean
814030|NCT01083732|Primary|Plasma Concentration of Free Dabigatran (BIBR 953 ZW).|Plasma concentration of free dabigatran (BIBR 953 ZW)|At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate and at 2 h, 50 h, and 72 h after multiple dose administration of dabigatran etexilate|PKS (evaluable cases)||ng/mL||Geometric Coefficient of Variation|Geometric Mean
814031|NCT01083732|Primary|Plasma Concentration of Total Dabigatran (SUM BIBR 953 ZW)|Plasma concentration of total dabigatran (SUM BIBR 953 ZW)|At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate and at 2 h, 50 h, and 72 h after multiple dose administration of dabigatran etexilate|"Pharmacokinetic set (PKS): This patient set included all treated patients who provided at least one pharmacokinetic/ pharmacodynamic (PK/PD) observation and had no important protocol violations (PVs) with respect to the statistical analysis of PK or PD endpoints.
PKS (evaluable cases)"||ng/mL||Geometric Coefficient of Variation|Geometric Mean
814032|NCT01083758|Secondary|Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient’s Global Assessment of Disease Severity at Weeks 2, 4, 8, and End of Treatment.|Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient’s Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation.|End of treatment|||% of participants w/ controlled disease|||Number
814035|NCT01083758|Secondary|Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient’s Global Assessment of Disease Severity at Weeks 2, 4, 8, and End of Treatment.|Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient’s Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation. The scale scores are based on the following; 1 = clear, 2 = very mild, 3 = mild, 4 = moderate, 5 = severe.|week 2|||% of participants w/ controlled disease|||Number
814036|NCT01083758|Secondary|Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign,Redness, Thickness, and Scaliness) From Baseline to Weeks 2, 4, 8, and End of Treatment.|Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score (ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 (best possible outcome) to 12 points (worst possible outcome).|Baseline and end of treatment (up to 8 weeks)|||Percentage change||Standard Deviation|Mean
814037|NCT01083758|Secondary|Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to Weeks 2, 4, 8, and End of Treatment.|Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score (ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 (best possible outcome) to 12 points (worst possible outcome).|Baseline and week 8|||Percentage change||Standard Deviation|Mean
814038|NCT01083758|Secondary|Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to Weeks 2, 4, 8, and End of Treatment.|Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score (ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 (best possible outcome) to 12 points (worst possible outcome).|Baseline and week 4|||percentage change||Standard Deviation|Mean
814039|NCT01083758|Secondary|Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to Weeks 2, 4, 8, and End of Treatment.|Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score(ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 (best possible outcome) to 12 points (worst possible outcome).|week 2|||Percentage change||Standard Deviation|Mean
814040|NCT01083758|Secondary|Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator’s Global Assessment (IGA) of Disease Severity at Weeks 2, 4, 8, and End of Treatment.|Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation.|End of treatment|||percentage of participants|||Number
814041|NCT01083758|Secondary|Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator’s Global Assessment (IGA) of Disease Severity at Weeks 2, 4, 8, and End of Treatment.|Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation.|week 8|||percentage of participants|||Number
814042|NCT01083758|Secondary|Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator’s Global Assessment (IGA) of Disease Severity at Weeks 2, 4, 8, and End of Treatment.|Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation.|week 4|||percentage of participants|||Number
814043|NCT01083758|Secondary|Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator’s Global Assessment (IGA) of Disease Severity at Weeks 2, 4, 8, and End of Treatment.|Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation. The IGA scale: 1 = clear, 2 = almost clear, 3 = mild, 4 = moderate, 5 = severe, and 6 = very severe.|week 2|||percentage of participants|||Number
814044|NCT01083758|Secondary|Change in Plasma PTH From Baseline (SV2) to Week 4 and Week 8|Change in plasma PTH (parathyroid hormone) from Baseline (SV2 = screening visit 2) to Week 4 and Week 8|Baseline and week 8|||ng/L||Standard Deviation|Mean
814045|NCT01083758|Primary|Change in Urinary Calcium:Creatinine Ratio From Baseline (SV2) to Week 4, Week 8 and, End of Treatment.|Change in urinary calcium:creatinine ratio from Baseline (SV2 = screening visit 2) to Week 4, Week 8 and, end of treatment.|Baseline and end of treatment (up to 8 weeks)|||mmol/g||Standard Deviation|Mean
814046|NCT01083758|Primary|Change in Urinary Calcium:Creatinine Ratio From Baseline (SV2) to Week 4, Week 8 and, End of Treatment.|Change in urinary calcium:creatinine ratio from Baseline (SV2 = screening visit 2) to Week 4, Week 8 and, end of treatment.|Baseline and week 8|||mmol/g||Standard Deviation|Mean
814047|NCT01083758|Primary|Change in Urinary Calcium:Creatinine Ratio From Baseline (SV2) to Week 4, Week 8 and, End of Treatment.|Change in urinary calcium:creatinine ratio from Baseline (SV2 = screening visit 2) to Week 4, Week 8 and, end of treatment.|Baseline and week 4|||mmol/g||Standard Deviation|Mean
814048|NCT01083758|Primary|Change in 24-hour Urinary Calcium Excretion From Baseline (SV2) to Week 4, Week 8, and End of Treatment.|Change in 24-hour urinary calcium excretion from Baseline (SV2 = screening visit 2) to Week 4, Week 8, and end of treatment.|Baseline and end of treatment (up to 8 weeks)|||mmol/24h||Standard Deviation|Mean
814049|NCT01083758|Primary|Change in 24-hour Urinary Calcium Excretion From Baseline (SV2) to Week 4, Week 8, and End of Treatment.|Change in 24-hour urinary calcium excretion from Baseline (SV2 = screening visit 2) to Week 4, Week 8, and end of treatment.|Baseline and week 8|||mmol/24h||Standard Deviation|Mean
814050|NCT01083758|Primary|Change in 24-hour Urinary Calcium Excretion From Baseline (SV2) to Week 4, Week 8, and End of Treatment.|Change in 24-hour urinary calcium excretion from Baseline (SV2 = screening visit 2) to Week 4, Week 8, and end of treatment.|Baseline and week 4|||mmol/24h||Standard Deviation|Mean
814054|NCT01083758|Primary|Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 and 60 Minutes After ACTH-challenge at Week 8.|Adrenal function can be measured by injecting a synthetic subunit of ACTH (Adrenocorticotropic hormone), and then measure the production of cortisol by the adrenal glands in response to this at 30 and 60 minutes after the injection.|week 8|Per protocol population||participants|||Number
814055|NCT01083758|Primary|Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 and 60 Minutes After ACTHchallenge at Week 4.|Adrenal function can be measured by injecting a synthetic subunit of ACTH Adrenocorticotropic hormone), and then measure the production of cortisol by the adrenal glands in response to this at 30 and 60 minutes after the injection.|week 4|Per Protocol Population||participants|||Number
814056|NCT01083758|Primary|Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After ACTH-challenge at Week 8|Adrenal function can be measured by injecting a synthetic subunit of ACTH Adrenocorticotropic hormone), and then measure the production of cortisol by the adrenal glands in response to this at 30 minutes after the injection.|week 8|Per Protocol Population||participants|||Number
814057|NCT01083758|Secondary|Change in Plasma PTH From Baseline (SV2) to Week 4 and Week 8|Change in plasma PTH (parathyroid hormone) from Baseline (SV2 = screening visit 2) to Week 4 and Week 8|Baseline and week 4|||ng/L||Standard Deviation|Mean
814058|NCT01083758|Primary|Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After ACTH-challenge at Week 4|Adrenal function can be measured by injecting a synthetic subunit of ACTH (Adrenocorticotropic hormone), and then measure the production of cortisol by the adrenal glands in response to this at 30 minutes after the injection.|Week 4|Per Protocol Population (based on the Full Analysis Set, but excluding subjects who did not apply any study medication, meet the inclusion criterion concerning adrenal function at baseline, or provide any results for the ACTH-challenge test after receiving study treatment)||participants|||Number
814059|NCT01083758|Primary|Percentage of Subjects With Adverse Drug Reactions (ADRs)|Adverse events for which the investigator did not describe the causal relationship to IP as not related|Throughout trial, up to 8 weeks|||percentage of participants|||Number
814060|NCT01083771|Secondary|To Assess Changes in the Body After 8 Weeks of Following a Mediterranean Diet|Post diet waist circumference|8 weeks|||centimeters||Standard Deviation|Mean
814061|NCT01083771|Primary|Changes in the Blood Chemistry (Fasting Triglycerides) After 8 Weeks of Following a Mediterranean Diet|Based on overall percentage change at baseline versus post diet|eight weeks|||percentage of change||Standard Deviation|Mean
814062|NCT01083810|Secondary|Change in Absolute CD4 Cell Count [CD4+ Cells/µL]|The evolution of participants' CD4-positive (CD4+) T-lymphocyte counts after starting the lopinavir/ritonavir-containing regimen was to be assessed by measuring the number of CD4+ cells at baseline and each subsequent study visit. Study visits were to occur at approximately Weeks 4, 12, 24, followed by 12-week intervals up to Week 144 in therapy-naive participants and up to Week 240 in the pre-treated and non-B subtype groups. CD4+ cell count results are reported as the change from Baseline in the absolute number of CD4+ cells per microliter.|Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks|All participants with CD4+ measurements at Baseline and any subsequent time point are included.||CD4+ cells/µL||Standard Deviation|Mean
814063|NCT01083810|Secondary|Percentage of Patients With HIV-1 RNA >500 Copies/ml|All 3 protocols recommended that HIV viral load tests be performed at Baseline and each study visit. Study visits were to occur at approximately Weeks 4, 12, and 24, followed by 12-week intervals up to Week 144 in therapy-naive participants and up to Week 240 in the pre-treated and non-B subtype groups. The percentage of participants with more than 500 HIV-1 RNA copies/mL at each time point is presented by subgroup.|Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks|All participants with HIV-1 RNA measurements at Baseline and any subsequent time point are presented, including those who discontinued due to virologic failure.||Percentage of participants|||Number
814064|NCT01083810|Secondary|Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml|All 3 protocols recommended that HIV viral load tests be performed at Baseline and each study visit. Study visits were to occur at approximately Weeks 4, 12, and 24, followed by 12-week intervals up to Week 144 in therapy-naive participants and up to Week 240 in the pre-treated and non-B subtype groups. The percentage of participants with HIV-1 RNA levels of 200 to less than 500 copies/mL at each time point is presented by subgroup.|Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks|All participants with HIV-1 RNA measurements at Baseline and any subsequent time point are presented, including those who discontinued due to virologic failure.||Percentage of participants|||Number
814065|NCT01083810|Secondary|Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml|All 3 protocols recommended that HIV viral load tests be performed at Baseline and each study visit. Study visits were to occur at approximately Weeks 4, 12, and 24, followed by 12-week intervals up to Week 144 in therapy-naive participants and up to Week 240 in the pre-treated and non-B subtype groups. The percentage of participants with HIV-1 RNA levels of 50 to less than 200 copies/mL at each time point is presented by subgroup.|Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks|All participants with HIV-1 RNA measurements at Baseline and any subsequent time point are presented, including those who discontinued due to virologic failure.||Percentage of participants|||Number
814066|NCT01083810|Secondary|Percentage of Patients With HIV-1 RNA <50 Copies/ml|All 3 protocols recommended that HIV viral load tests be performed at Baseline and each study visit. Study visits were to occur at approximately Weeks 4, 12, and 24, followed by 12-week intervals up to Week 144 in therapy-naive participants and up to Week 240 in the pre-treated and non-B subtype groups. The percentage of participants with HIV-1 ribonucleic acid (RNA) less than 50 copies/mL at each time point is presented by subgroup.|Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks|All participants with HIV-1 RNA measurements at Baseline and any subsequent time point are presented, including those who discontinued due to virologic failure.||Percentage of participants|||Number
814084|NCT01084005|Secondary|Percentage of Patients Who Have a HbA1c Lowering by at Least 0.5% at Week 24|The percentage of patients with an HbA1c reduction of ≥0.5% at week 24 from baseline was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c reduction less than 0.5%|Baseline and week 24|FAS (NCF)||percentage of patients|||Number
814085|NCT01084005|Secondary|Percentage of Patients With HbA1c <7.0% at Week 24|The percentage of patients with an HbA1c value below 7% at week 24 were calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 7%.|Baseline and week 24|FAS (NCF)||percentage of patients|||Number
814067|NCT01083810|Primary|Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs|Standard genotypic resistance assays were developed for HIV-1 viral load levels greater than 500 to 1000 copies per milliliter (mL). All 3 protocols recommended this testing be done at Baseline prior to lopinavir/ritonavir therapy and (if possible) in cases of virologic failure. The exact timing varied and depended on whether there was an adequate viral load and physician clinical judgment. Participants with resistance to lopinavir/ritonavir, nucleoside reverse transcriptase inhibitors (NRTI) or non-nucleoside reverse transcriptase inhibitors (NNRTI) at Baseline and follow-up are reported.|Baseline and at any timepoint where testing is possible|All participants with resistance testing at baseline and follow-up are presented.||Participants|||Number
814068|NCT01083849|Secondary|Mean Calcium-Phosphate Product Levels by Visit||Months 0, 3, 6, 9, and 12|The Pre-Dialysis and Dialysis groups were split into subgroups. Secondary endpoint investigations were done for the 733 participants in these Pre-Dialysis or Dialysis subgroups; 26 out of the 759 participants had a missing subgroup allocation.||mmol²/l²||Standard Deviation|Mean
814069|NCT01083849|Secondary|Mean Intact Parathormone (iPTH) Levels by Visit||Months 0, 3, 6, 9, and 12|The Pre-Dialysis and Dialysis groups were split into subgroups. Secondary endpoint investigations were done for the 733 participants in these Pre-Dialysis or Dialysis subgroups; 26 out of the 759 participants had a missing subgroup allocation.||pmol/L||Standard Deviation|Mean
814070|NCT01083849|Primary|Time to Achieve Target Range of Intact Parathyroid Hormone (iPTH) Levels Within the Target Range After 12 Months|Participants achieved Intact Parathyroid Hormone (iPTH) levels within the target range of Kidney Disease Quality Outcome Initiative (K/DOQI) treatment guidelines (Chronic Kidney Disease (CKD), stage 3: 35 to 70 pg/mL; CKD stage 4: 70 to 110 pg/mL; CKD stage 5: 150 to 300 pg/mL).|Up to 12 months|Participants with a determined chronic kidney disease (CKD) stage||days||Standard Deviation|Mean
814071|NCT01083849|Secondary|Mean Duration of Disability by Visit||Months 0, 3, 6, 9, and 11|The Pre-Dialysis and Dialysis groups were split into subgroups. Secondary endpoint investigations were done for the 733 participants in these Pre-Dialysis or Dialysis subgroups; 26 out of the 759 participants had a missing subgroup allocation.||days||Standard Deviation|Mean
814072|NCT01083849|Secondary|Mean Duration of Hospitalization by Visit||Months 0, 3, 6, 9, and 11|The Pre-Dialysis and Dialysis groups were split into subgroups. Secondary endpoint investigations were done for the 733 participants in these Pre-Dialysis or Dialysis subgroups; 26 out of the 759 participants had a missing subgroup allocation.||days||Standard Deviation|Mean
814073|NCT01083849|Secondary|Number of Participants With Elevated Calcium-Phosphorus Product|Elevated Calcium-Phosphorus Product was defined as having a calcium-phosphate product level greater than 65 mg^2/dL^2, in one measurement. Serum calcium-phosphorus product was measured at every study visit.|Months 0, 3, 6, 9, and 12|The Pre-Dialysis and Dialysis groups were split into subgroups. Secondary endpoint investigations were done for the 733 participants in these Pre-Dialysis or Dialysis subgroups; 26 out of the 759 participants had a missing subgroup allocation.||participants|||Number
814074|NCT01083849|Secondary|Number of Participants With Hyperphosphatemia|Hyperphosphatemia was defined as having a serum phosphate level greater than 6.5 mg/dL (2.10 mmol/L), in one measurement. Serum phosphate was measured at every study visit.|Months 0, 3, 6, 9, and 12|The Pre-Dialysis and Dialysis groups were split into subgroups. Secondary endpoint investigations were done for the 733 participants in these Pre-Dialysis or Dialysis subgroups; 26 out of the 759 participants had a missing subgroup allocation.||participants|||Number
814075|NCT01083849|Secondary|Number of Participants With Hypercalcemia|Hypercalcemia was defined as having a serum calcium level greater than 11.2 mg/dL (2.79 mmol/L), in one measurement. Serum calcium was measured at every study visit.|Months 0, 3, 6, 9, and 12|The Pre-Dialysis and Dialysis groups were split into subgroups. Secondary endpoint investigations were done for the 733 participants in these Pre-Dialysis or Dialysis subgroups; 26 out of the 759 participants had a missing subgroup allocation.||participants|||Number
814076|NCT01083849|Primary|Percentage of Participants Who Achieved Intact Parathyroid Hormone (iPTH) Levels Within the Target Range After 12 Months|Participants achieved Intact Parathyroid Hormone (iPTH) levels within the target range of Kidney Disease Quality Outcome Initiative (K/DOQI) treatment guidelines (Chronic Kidney Disease (CKD), stage 3: 35 to 70 pg/mL; CKD stage 4: 70 to 110 pg/mL; CKD stage 5: 150 to 300 pg/mL).|Up to 12 Months|Participants with a determined chronic kidney disease (CKD) stage||percentage of participants|||Number
814077|NCT01083901|Secondary|Change in Lower Body Strength|Strength was measured using the one-repetition maximum method. Lower body strength was a composite of knee flexion, knee extension, and leg press strength.|16 weeks|||lbs||Standard Error|Mean
814078|NCT01083901|Secondary|Changes in Upper Body Strength.|Strength was measured using the one-repetition maximum method. Upper body strength was a composite of bench press, overhead press, seated row, and lateral pull-down strength.|16 weeks|||lbs||Standard Error|Mean
814079|NCT01083901|Secondary|Change in Total Body Fat Mass|Change from baseline to 16 weeks in total body fat mass.|16 weeks|||kg||Standard Error|Mean
814080|NCT01083901|Primary|Change in Total Body Fat-free Mass|change from baseline to 16 weeks in fat-free mass measured by DXA (Hologic Discovery W, version 12.6)|16 weeks|All participants with baseline and 16 week data were included in the analysis (i.e., intention-to-treat).||kg||Standard Error|Mean
814081|NCT01083979|Secondary|Bladder Appearance|The secondary objective to assess treatment efficacy will compare the number of bladder ulcers pre-treatment to the number of ulcers visualized at 12 weeks, the end of the study.|Baseline to 12 Weeks|||Ulcers|||Number
814082|NCT01083979|Primary|Change in Symptom and Problem Severity|The primary objective is to determine the impact of 4 weekly bladder instillations of liposomes on symptoms in one patient with ulcerative interstitial cystitis (IC). The primary endpoint will be assessed at the end of the study, 8 weeks after the last bladder instillation, and will be measured by the O'Leary-Sant IC Symptom and Problem Indices (ICSI-PI) questionnaire. The ICSI is composed of 4 questions that address the occurrence of IC symptoms, specifically urinary urgency, frequency, nocturia, and bladder pain. Scores range from 0 (Not at All) to 5 (Almost Always). The IC Problem Indices questionnaire is also composed of 4 questions. Each question asks the patient to indicate how big a problem each of the 4 symptoms are to them. Scores range from 0 (No Problem) to 4 (Big Problem). Responses to all 8 questions are added together to create a total ICSI-PI score. The total ICSI-PI scores ranges from 0 to 36. A lower score indicates less IC symptoms and/or related problem|Baseline to 12 weeks|||units on a scale|||Number
814086|NCT01084005|Secondary|Percentage of Patients With HbA1c <7.0% at Week 24|The percentage of patients with an HbA1c value below 7% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 7%. Only patients with baseline HbA1c >= 7%|Baseline and week 24|FAS with baseline HbA1c >=7% and non-completers considered as failure imputation (NCF)||percentage of patients|||Number
814087|NCT01084005|Secondary|FPG Change From Baseline to Week 18|This change from baseline reflects the Week 18 FPG minus the baseline FPG. Means are treatment-adjusted for baseline HbA1c, baseline FPG and prior use of insulin, week repeated within patient and week by treatment interaction.|Baseline and week 18|FAS (OC)||mg/dL||Standard Error|Mean
814088|NCT01084005|Secondary|FPG Change From Baseline to Week 12|This change from baseline reflects the Week 12 FPG minus the baseline FPG. Means are treatment-adjusted for baseline HbA1c, baseline FPG and prior use of insulin, week repeated within patient and week by treatment interaction.|Baseline and week 12|FAS (OC)||mg/dL||Standard Error|Mean
814089|NCT01084005|Secondary|FPG Change From Baseline to Week 6|This change from baseline reflects the Week 6 FPG minus the baseline FPG. Means are treatment-adjusted for baseline HbA1c, baseline FPG and prior use of insulin, week repeated within patient and week by treatment interaction.|Baseline and week 6|FAS Observed cases (OC)||mg/dL||Standard Error|Mean
814090|NCT01084005|Secondary|FPG Change From Baseline to Week 24|This change from baseline reflects the Week 24 FPG minus the baseline FPG. Means are treatment-adjusted for baseline HbA1c, baseline FPG and prior use of insulin.|Baseline and week 24|FAS (LOCF)||mg/dL||Standard Error|Mean
814091|NCT01084005|Secondary|HbA1c Change From Baseline to Week 18|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and prior use of insulin.|Baseline and week 18|FAS (LOCF)||Percent||Standard Error|Mean
814092|NCT01084005|Secondary|HbA1c Change From Baseline to Week 12|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and prior use of insulin.|Baseline and week 12|FAS (LOCF)||Percent||Standard Error|Mean
814093|NCT01084005|Secondary|HbA1c Change From Baseline to Week 6|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 6 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and prior use of insulin.|Baseline and week 6|FAS (LOCF)||Percent||Standard Error|Mean
814094|NCT01084005|Primary|HbA1c Change From Baseline to Week 24|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and prior use of insulin.|Baseline and week 24|FAS consisting of all randomised patients who were treated with at least one dose of study drug, had a baseline, and at least 1 on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as the imputation rule.||Percent||Standard Error|Mean
814095|NCT01084083|Secondary|Primary Clinical Response Rate|Primary clinical response rate is defined as the proportion of patients with complete response or partial response at their primary sites after induction therapy. Response status for the primary site was classified by clinical examination using endoscopy. If, however, the clinical response status of the primary was unclear based on endoscopy, then the CT or MRI (required at the end of induction) was used to determine status of the primary. If clinical and radiological evaluation of the primary was unclear, a biopsy was considered at the discretion of the treating physician.|assessed within 14 days after delivery of the third cycle of induction therapy|eligible and treated patients||percentage of participants||95% Confidence Interval|Number
814096|NCT01084083|Secondary|24-months Overall Survival|OS was defined as the time from registration to death, or censored at last date known alive. Kaplan-Meier method was used to estimate the overall survival rate at 24 months.|assessed within 14 days after delivery of the third cycle of induction therapy, and 8 weeks and 6 months after completion of concurrent therapy, then every 6 months until progression or until 3 years from study entry|eligible and treated patients||percentage of participants||95% Confidence Interval|Number
814097|NCT01084083|Primary|24-month Progression-free Survival|24-month progression-free survival is defined as the proportion of patients who were alive and progression-free at 24 months post registration. The primary study population for this endpoint is patients who were confirmed post-induction clinical complete response (CR) at their primary sites and subsequently received 5400 cGy radiation therapy to their primary sites.|assessed within 14 days after delivery of the third cycle of induction therapy, and 8 weeks and 6 months after completion of concurrent therapy, then every 6 months until progression or until 3 years from study entry|patients who were confirmed post-induction clinical complete response (CR) at their primary sites and subsequently received 5400 cGy radiation therapy to their primary sites||percentage of participants||95% Confidence Interval|Number
814098|NCT01084135|Secondary|Behavior Rating Inventory of Executive Function-Preschool (BRIEF-P)|The Behavior Rating Inventory of Executive Function-Preschool Version (BRIEF-P) is a parent report measure of executive function behaviors in children in their home setting. It yields an overall score (Global Executive Composite, GEC) that is based on its five clinical scales. Raw scores range from 63 to 189. Higher scores suggest that an individual’s executive function skills are more problematic. In this study, the change between each subject’s raw score at Baseline and the Final Visit was computed for the Global Executive Composite. A decline in raw scores from Baseline to the Final Visit indicates improvement.|Baseline and Final (Week 20) visit|All subjects who completed the 20 week period were included in analysis except for 1 subjects whose form was completed incorrectly.||units on a scale||Standard Deviation|Mean
814099|NCT01084135|Primary|Vineland Adaptive Behavior Scales, Second Edition (Survey Interview Form)|The Vineland Adaptive Behavior Scales, Second Edition (Survey Interview Form) is a measure of adaptive behavior in children, adolescents and adults. It yields an overall standard score (Adaptive Behavior Composite, ABC) and age standard scores in four domains. ABC scores have a mean of 100 and a standard deviation of 15 (range = 20 to 160). Higher scores suggest a higher level of adaptive functioning. In this study, the change between each subject’s ABC at Baseline and the Final Visit was computed. A rise in standard scores from Baseline to the Final Visit indicates improvement.|Baseline & Study termination (Week 20)|All subjects who completed the 20 week period were included in analysis except for 2 subjects whose form was completed incorrectly.||units on a scale||Standard Deviation|Mean
814100|NCT01084148|Secondary|Local Tolerance of V0034 CR 01B After Long-term Use and Patient's Benefit and Acceptability of V0034 CR 01B||133 days||||||
814101|NCT01084148|Primary|Treatment Response of Xerosis|"Treatment response rate of uremic xerosis on 5 test areas (right lower leg, left lower leg, forearm having no arterio-venous shunt, chest, dorsum of the neck), using a defined 5-point severity scale:
0 = smooth skin
= patches of fine, powdery scales
= diffuse ashy appearance with many fine scales
= moderate scaling with beginning cracks
= intense scaling, moderate cracks Treatment response was defined as a score of 0 or 1 on all test areas at the end of Period I, and a reduction of at least 2 grades on at least one test area (primary efficacy parameter, Period I)."|28 days|One patient in V0034 CR 01B Vehicle arm randomized but not treated||participants|||Number
814102|NCT01084174|Secondary|Between Arm Change in IgE From Baseline to 12 Months|IgE levels are measured in kilo units of Antibody per liter (kUa/L) and were collected at baseline and at 12 months|Baseline and 12 months|||kUa/L||Full Range|Median
814103|NCT01084174|Secondary|Between Arm Change in IgE From Baseline to 6 Months|Serum immunoglobulin E (IgE) levels are measured in kilo units of Antibody per liter (kUa/L) and were collected at baseline and at 6 months|Baseline and 6 months|||kUa/L||Full Range|Median
814104|NCT01084174|Secondary|Between Arm Change in IgE From Baseline to End of Dose Build-up (up to 16 Weeks)||Baseline to end of dose build-up (up to 16 weeks)|||kUa/L||Full Range|Mean
814105|NCT01084174|Secondary|Between Arm Change in IgG4 From Baseline to 12 Months|IgG4 levels are measured in milligrams of Antibody per liter (mga/L) and were collected at baseline and at 12 months|Baseline and 12 months|One participant in the Active SLIT/Placebo OIT arm and 4 participants in the Active OIT/Placebo SLIT arm discontinued prior to month 12.||mga/L||Full Range|Median
814106|NCT01084174|Secondary|Between Arm Change in IgG4 From Baseline to 6 Months|IgG4 levels are measured in milligrams of Antibody per liter (mga/L) and were collected at baseline and at 6 months|Baseline and 6 months|One participant in the Active sublingual immunotherapy (SLIT)/Placebo oral immunotherapy (OIT) arm and 4 participants in the Active OIT/Placebo SLIT arm discontinued prior to month 6.||mga/L||Full Range|Median
814107|NCT01084174|Secondary|Between Arm Change in IgG4 From Baseline to End of Dose Build-up (up to 16 Weeks)|Serum immunoglobulin G4 (IgG4) levels are measured in milligrams of Antibody per liter (mga/L) and were collected at baseline and at the end of dose build-up (up to 16 weeks)|Baseline and end of dose build-up (up to 16 weeks)|||mga/L||Full Range|Median
814108|NCT01084174|Primary|Number of Participants With Induced Peanut Desensitization at 12 Months|Peanut desensitization was defined as a greater than 10-fold increase in oral food challenge (OFC) threshold after 12 months of therapy.|12 months|||Participants|||Count of Participants
814109|NCT01084239|Secondary|Rate of ED Discharge|Direct discharge from Emergency Department|Duration of stay in the hospital during the initial visit|||participants|||Number
814110|NCT01084239|Secondary|Cost-effectiveness|Total cost during index hospitalization|Duration of stay in the hospital during the initial visit|||US Dollars||Standard Deviation|Mean
814111|NCT01084239|Secondary|MACE|Major Adverse Cardiovascular Events, All though these events are called MACE they do not qualify as adverse or serious adverse events. As these events are expected in some individuals in this population. Only MACE that occured within 72 hours after hospital discharge were considered serious adverse events in this trial. There were no such events.|72 hours after discharge up to 28 days after enrollment.|||events|||Number
814112|NCT01084239|Secondary|Healthcare Utilization|Number of patients with diagnostic testing (CCTA, ETT, SPECT, stress echocardiography, and invasive coronary angiography)|Duration of stay in the hospital during the initial visit|||participants|||Number
814113|NCT01084239|Secondary|Time to Diagnosis||Time from ED arrival to first positive test (all tests except Echocardiography Rest and including troponins ) if discharge diagnosis is ACS, otherwise time to performance of last test (all tests except Echocardiography Rest and including troponins ).|||hours||Standard Deviation|Mean
814114|NCT01084239|Primary|Length of Hospital Stay||Duration of stay in the hospital during the initial visit|||hours||Standard Deviation|Mean
814115|NCT01084265|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition.|Day 14|Safety analysis set included all participants who received investigational drug for at least one time.||participants|||Number
814116|NCT01084265|Secondary|Number of Participants With Confirmed Pregnancies: Biochemical Pregnancies and Clinical Pregnancies|Biochemical pregnancy was defined as a pregnancy diagnosed only by the detection of hCG in serum or urine and that does not develop into a clinical pregnancy. Clinical pregnancy was defined as a pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It includes ectopic pregnancy.|Day 14|Per protocol set included all participants who completely met all the requirements of clinical trial protocol.||participants|||Number
814117|NCT01084265|Secondary|Average Change of E2 Level in Participants Per Day up to Day 14|The average change was calculated by assessing the E2 levels on 4 timepoints until day 14 (day 1, day 5, day 10, day 14 [hCG administration day]).|up to Day 14|Per protocol set included all participants who completely met all the requirements of clinical trial protocol.||pg/mL per day||Standard Deviation|Mean
814118|NCT01084265|Secondary|Mean Number of Follicles With the Diameter Above 17 mm on the Day of hCG Injection in Treatment Cycle||Day 14|Per protocol set included all participants who completely met all the requirements of clinical trial protocol.||follicles||Standard Deviation|Mean
814119|NCT01084265|Secondary|Mean Number of Follicles With Diameter in the Range of 10-17 mm on the Day of hCG Injection in Treatment Cycle||Day 14|Per protocol set included all participants who completely met all the requirements of clinical trial protocol.||follicles||Standard Deviation|Mean
814120|NCT01084265|Primary|Number of Participants Who Refused to Take hCG Injection|Participant refused to take hCG injection for the concern of OHSS or the participant was pregnant.|Day 14|Per protocol set included all participants who completely met all the requirements of clinical trial protocol.||participants|||Number
814121|NCT01084265|Primary|Number of Participants With E2 Level in Blood Serum Above 109 pg/mL on the Day of hCG Injection||Day 14|Per protocol set included all participants who completely met all the requirements of clinical trial protocol.||participants|||Number
837710|NCT01307631|Secondary|Duration of Overall Survival|Estimated by using Kaplan-Meier analysis.|Up to 3 years|Overall survival of all patients on study.||months||Full Range|Median
814123|NCT01084265|Primary|Number of Participants Who Met Both Index 1 and Index 2|The three indices were defined as; Index 1: diameter of at least one follicle is greater than 17 mm; Index 2: serum oestradiol (E2) level in blood serum above 109 picogram/ milliliter (pg/mL) on human chorionic gonadotropin (hCG) injection day; Index 3: participant refuses to take hCG injection for the concern of ovarian hyperstimulation syndrome (OHSS) or participant is pregnant. A subset of these participants met Index 3.|Day 14|Per protocol set included all participants who completely met all the requirements of clinical trial protocol.||participants|||Number
814139|NCT01077921|Secondary|Overall Change of Diastolic Blood Pressure Levels|Overall change of Diastolic Blood Pressure levels from baseline to post intervention (Week 0 to 6 and week 8 to 14) Placebo vs. Propranolol treated|Week 0 to 6 and week 8 to 14|||mmHg||Inter-Quartile Range|Median
814140|NCT01077921|Secondary|Overall Change of Systolic Blood Pressure Levels|Overall change of Systolic Blood Pressure levels from baseline to post intervention (Week 0 to 6 and week 8 to 14) Placebo vs. Propranolol treated|Week 0 to 6 and week 8 to 14|||mmHg||Inter-Quartile Range|Median
814141|NCT01077921|Secondary|Overall Change of Oxygen Saturation (02Sat) Levels|Overall change of Oxygen Saturation (02Sat) levels from baseline to post intervention( Week 0 to 6 and week 8 to 14) Placebo vs. Propranolol treated|Week 0 to 6 and week 8 to 14|||percentage of oxygen saturation||Inter-Quartile Range|Median
814142|NCT01077921|Secondary|Overall Change of Lactate Dehydrogenase (LDH) Levels|Overall change of LDH levels from baseline to post intervention( Week 0 to 6 and week 8 to 14) Placebo vs. Propranolol treated|Week 0 to 6 and week 8 to 14|||IU/L||Inter-Quartile Range|Median
814143|NCT01077921|Secondary|Overall Change of Hematocrit (Hct) Levels|Overall change of Hematocrit (Hct) levels from baseline to post intervention( Week 0 to 6 and week 8 to 14) Placebo vs. Propranolol treated|Week 0 to 6 and week 8 to 14|||percentage of red blood cells||Inter-Quartile Range|Median
814144|NCT01077921|Secondary|Overall Change of Hemoglobin (Hgb) Levels|Overall change of Hemoglobin (Hgb) levels from baseline to post intervention( Week 0 to 6 and week 8 to 14) Placebo vs. Propranolol treated|Week 0 to 6 and week 8 to 14|||gm/dL||Inter-Quartile Range|Median
814145|NCT01077921|Secondary|Overall Change of Plasma Levels of sVCAM-1|Biomarkers of Endothelial Activation and Dysfunction: Overall change of Plasma levels of sVCAM-1 measured in triplicate on plasma samples using commercially available ELISA kits from baseline to post intervention ( Week 0 to 6 or week 8 to 14)|Week 0 to 6 and week 8 to 14|||ng/ml||Standard Deviation|Mean
814146|NCT01077921|Secondary|Overall Change of Plasma Levels of sICAM-1|Biomarkers of Endothelial Activation and Dysfunction: Overall change of Plasma levels of sICAM-1 measured in triplicate on plasma samples using commercially available ELISA kits from baseline to post intervention ( Week 0 to 6 and week 8 to 14)|Week 0 to 6 and week 8 to 14|||ng/ml||Standard Deviation|Mean
814147|NCT01077921|Secondary|Overall Change of Plasma Levels of sP-selectin|Biomarkers of Endothelial Activation and Dysfunction: Overall change of Plasma levels of sP-selectin measured in triplicate on plasma samples using commercially available ELISA kits from baseline to post intervention ( Week 0 to 6 and weeks 8 to 14).|Week 0 to 6 and week 8 to 14|||ng/ml||Standard Deviation|Mean
814148|NCT01077921|Primary|SS RBC Adhesion (Epi -3d/cm2- vs. Sham) by Treatment|The stickiness of SS RBC will be evaluated by a well-established in vitro assay of adhesion of SS RBCs to cultured endothelial cells using a flow chamber. Overall change of adhesion from baseline to post intervention( Week 0 to 6 and week 8 to 14) in unstimulated cells (Sham treated) vs. Stimulated Red Blood Cells (Epi-treated) at 3 dyne/cm2|Week 0 to 6 and week 8 to 14|||Percentage of total RBC||Standard Deviation|Mean
814149|NCT01077921|Primary|SS RBC Adhesion (Epi -2d/cm2- vs. Sham) by Treatment|The stickiness of SS RBC will be evaluated by a well-established in vitro assay of adhesion of SS RBCs to cultured endothelial cells using a flow chamber. Overall change of adhesion from baseline to post intervention( Week 0 to 6 and week 8 to 14) in unstimulated cells (Sham treated) vs. Stimulated Red Blood Cells (Epi-treated) at 2 dyne/cm2|Week 0 to 6 and week 8 to 14|||Percentage of total RBC||Standard Deviation|Mean
814150|NCT01077921|Secondary|Overall Change of Plasma Levels of sE-selectin|Biomarkers of Endothelial Activation and Dysfunction: Overall change of Plasma levels of sE-selectin measured in triplicate on plasma samples using commercially available ELISA kits from baseline to post intervention ( Week 0 to 6 and week 8 to 14).|Week 0 to 6 and week 8 to 14|||ng/ml||Standard Deviation|Mean
815074|NCT01096680|Secondary|Psychomotor Vigilance Task (PVT) Scores|PVT assesses behavioral alertness. Subjects were required to respond to a visual stimulus by pressing a button on a mechanical device and the reaction time was measured. Higher scores indicate attention lapses.|Over a period of 12 hours|FAS||msec||Standard Error|Least Squares Mean
814151|NCT01077921|Primary|SS RBC Adhesion (Epi -1d/cm2- vs. Sham) by Treatment|The stickiness of SS RBC will be evaluated by a well-established in vitro assay of adhesion of SS RBCs to cultured endothelial cells using a flow chamber. Overall change of adhesion from baseline to post intervention( Week 0 to 6 and week 8 to 14) in unstimulated cells (Sham treated) vs. Stimulated Red Blood Cells (Epi-treated) at 1 dyne/cm2|Week 0 to 6 and week 8 to 14|||Percentage of total RBC||Standard Deviation|Mean
814152|NCT01077960|Secondary|Oral Glucose Tolerance Testing - Change From Baseline to Week 12 in Fasting Glucose|Oral glucose testing|baseline to 12 weeks|The analysis population reported here comprised the subjects who received at least one dose of study drug||mg/dL||Standard Deviation|Mean
814153|NCT01077960|Secondary|Oral Glucose Tolerance Testing - Change From Baseline to Week 12 in 120 Minute Glucose|Oral glucose testing|baseline to 12 weeks|The analysis population reported here comprised the subjects who received at least one dose of study drug||mg/dL||Standard Deviation|Mean
814154|NCT01077960|Secondary|Oral Glucose Tolerance Testing - Change From Baseline to Week 12 in Fasting Insulin|Oral glucose tolerance testing|baseline to 12 weeks|The analysis population reported here comprised the subjects who received at least one dose of study drug||mcIU/mL||Standard Deviation|Mean
814155|NCT01077960|Secondary|Change From Baseline to Week 12 in Insulin-like Growth Factor I|Circulating levels of IGF-I|baseline to 12 weeks|The analysis population reported here comprised the subjects who received at least one dose of study drug||ng/mL||Standard Deviation|Mean
814156|NCT01077960|Secondary|Change From Baseline to Week 12 in Waist Circumference|Measured by anthropometry|baseline to 12 weeks|The analysis population reported here comprised the subjects who received at least one dose of study drug||cm||Standard Deviation|Mean
814157|NCT01077960|Primary|Change From Baseline to Week 12 in Trunk Fat as Assessed by Dual-Energy X-Ray Absorptiometry (DXA) Scan||baseline to 12 weeks|The analysis population reported here comprised the subjects who received at least one dose of study drug||kg||Standard Deviation|Mean
814158|NCT01077973|Secondary|Cumulative Percentage of Participants With Complete Relief|Complete relief was defined as a PRR of 4. PRR was assessed on a 5-point categorical pain relief rating scale where 0=No relief to 4=Complete relief.|1, 2, 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||Percentage of participants|||Number
814159|NCT01077973|Secondary|Cumulative Percentage of Participants With Treatment Failure|Percentage of participants who withdrew from the study due to lack of efficacy or received rescue medication.|0 to 3 hours|Data was not analyzed as there were no treatment failures observed and no participant received rescue medication in the study.||Percentage of participants|||Number
814160|NCT01077973|Secondary|Time to Treatment Failure|Median time of dropping out of the participants from the study due to lack of efficacy or received rescue medication, whichever came first.|0 to 3 hours|Data was not analyzed as there were no treatment failures observed and no participant received rescue medication in the study.||Minutes||95% Confidence Interval|Median
814161|NCT01077973|Secondary|Cumulative Percentage of Participants With Confirmed First Perceptible Relief|"Percentage of participants with first perceptible relief evaluated by stopping a stopwatch labeled 'first perceptible relief' at the moment the participant first began to experience any relief. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered. First perceptible relief was considered confirmed by meaningful relief if the participant achieved both first perceptible and meaningful relief by either depressing the second stopwatch or by indicating that his/her first perceptible relief was also meaningful."|0.5, 1, 2, 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||Percentage of participants|||Number
814162|NCT01077973|Secondary|Cumulative Percentage of Participants With Meaningful Relief|Percentage of participants with meaningful relief evaluated by stopping a second stopwatch labeled ‘meaningful relief' at the moment the participant first began to experience meaningful relief. It was also considered achieved if the participant stated “meaningful relief” at the time the first stopwatch was depressed. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered.|0.5, 1, 2, 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||Percentage of participants|||Number
814163|NCT01077973|Secondary|Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID)|SPRID: time-weighted sum of PRID over 2 and 3 hours. SPRID score range was -2(worst) to 14(best) for SPRID 0-2 and -3 (worst) to 21 (best) for SPRID 0-3. PRID: sum of PID and PRR at each time point. Total score range for PRID: -1=worst to 7=best. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderately severe to 3=severe). Total score range for PID: -1(worst) to 3(best), PRR: assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief).|0 to 2, 0 to 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||Units on a scale||Standard Deviation|Mean
814164|NCT01077973|Secondary|Time-weighted Sum of Pain Relief Rating (TOTPAR)|TOTPAR: time-weighted sum of PRR over 2 and 3 hours. TOTPAR score range was 0 (worst) to 8 (best) for TOTPAR 0-2 and 0 (worst) to 12 (best) for TOTPAR 0-3. PRR was assessed on a 5-point categorical pain relief rating scale wherein 0=No relief to 4=Complete relief.|0 to 2, 0 to 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||Units on a scale||Standard Deviation|Mean
814165|NCT01077973|Secondary|Time-weighted Sum of Pain Intensity Difference (SPID)|SPID: time-weighted sum of PID over 2 and 3 hours. SPID score range was -2(worst) to 6 (best) for SPID 0-2 and -3 (worst) to 9 (best) for SPID 0-3. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderately severe to 3=severe). Total score range for PID: -1(worst) to 3 (best).|0 to 2, 0 to 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||Units on a scale||Standard Deviation|Mean
814179|NCT01078090|Secondary|Patients Global Assessment of Disease Activity Over Time|Participants indicated their global assessment of disease activity over the last 7 days on a visual analog scale (VAS) ranging from 0 (best) to 10 (worst) cm; lower scores indicate better patient status.|Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60|"Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. n indicates the number of participants with available data at each time point."||cm||Standard Deviation|Mean
814166|NCT01077973|Secondary|Sum of Pain Relief Rating and Pain Intensity Difference (PRID)|PRID was sum of PID and PRR at each post-dosing time point. The overall possible score range, for PRID was -1 (worst) to 7 (best). PID was derived by subtracting the pain severity score at a given post-dosing time point [pain severity score range 0 (none) to 3 (severe)] from the baseline score [Baseline pain severity score range 2 (moderately severe) to 3 (severe)]. Total possible score range for PID: -1 (worst) to 3 (best). PRR was assessed on 5-point categorical pain relief rating scale (0=No relief to 4=Complete relief).|1, 2, 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||Units on a scale||Standard Deviation|Mean
814167|NCT01077973|Secondary|Pain Intensity Difference (PID)|PID was derived by subtracting the pain severity score at a given post-dosing time point [pain severity score range 0 (none) to 3 (severe)] from the baseline score [Baseline pain severity score range 2 (moderately severe) to 3 (severe)]. Total possible score range for PID: -1 (worst) to 3 (best).|1, 2, 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||Units on a scale||Standard Deviation|Mean
814168|NCT01077973|Secondary|Pain Relief Rating (PRR)|PRR was assessed on a 5-point categorical pain relief rating scale wherein 0=No relief to 4=Complete relief.|1, 2, 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||Units on a scale||Standard Deviation|Mean
814169|NCT01077973|Secondary|Time to Confirmed First Perceptible Relief|"Participants evaluated the time to first perceptible relief by stopping a stopwatch labeled 'first perceptible relief' at the moment the participant first began to experience any relief. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered. First perceptible relief was considered confirmed by meaningful relief if the participant achieved both first perceptible and meaningful relief by either depressing the second stopwatch or by indicating that his/her first perceptible relief was also meaningful."|0 to 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||Minutes||95% Confidence Interval|Median
814170|NCT01077973|Secondary|Time to Onset of Meaningful Relief: Remaining Comparisons|Participants evaluated the time to meaningful relief by stopping a second stopwatch labeled ‘meaningful relief' at the moment the participant first began to experience meaningful relief. It was also considered achieved if the participant stated “meaningful relief” at the time the first stopwatch was depressed. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered.|0 to 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||Minutes||95% Confidence Interval|Median
814171|NCT01077973|Primary|Time to Onset of Meaningful Relief for Ibuprofen Sodium Versus Ibuprofen (Motrin IB) Tablet|Participants evaluated the time to meaningful relief by stopping a second stopwatch labeled ‘meaningful relief' at the moment the participant first began to experience meaningful relief. It was also considered achieved if the participant stated “meaningful relief” at the time the first stopwatch was depressed. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered.|0 to 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||Minutes||95% Confidence Interval|Median
814172|NCT01077973|Primary|Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference From 0-3 Hours (SPRID 0-3) for Ibuprofen Sodium Versus Placebo Tablet|SPRID:time-weighted sum of pain relief rating combined with pain intensity difference (PRID) over 3 hours. SPRID score range:-3 (worst) to 21 (best) for SPRID 0-3. PRID: sum of pain intensity differences (PID) and pain relief rating(PRR) at each time point. PRID score range: -1=worst to 7=best. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderately severe to 3=severe). Total score range for PID: -1(worst) to 3 (best). PRR:assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief).|0 to 3 hours|Intent-to-treat (ITT) population included all randomized participants who received study medication and provided a baseline assessment.||Units on a scale||Standard Deviation|Mean
814173|NCT01078090|Secondary|Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication||Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60|"Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. n indicates the number of participants with available data at each time point."||percentage of participants|||Number
814174|NCT01078090|Secondary|Percentage of Participants With In-patient Hospitalization|The percentage of participants with in-patient hospitalization in the prior 6 months. Baseline data includes in-patient hospitalizations that occurred within the prior 12 months.|Baseline and Months 6, 12, 18, 24, 30, 36, 48, and 60|Full analysis set participants who were employed and with available data at each time point (indicated by n)||percentage of participants|||Number
814175|NCT01078090|Secondary|Number of Days Missed From Work Due to Rheumatoid Arthritis|Participants reported the number of days they had missed from work in the prior 6 months due to rheumatoid arthritis. The Baseline measurement includes data for the prior 12 months.|Baseline and Months 6, 12, 18, 24, 30, 36, 48, and 60|Full analysis set participants who were employed and with available data at each time point (indicated by n)||days||Standard Deviation|Mean
814176|NCT01078090|Secondary|Percentage of Participants With Impairment in Daily Activities|Participants were asked to report how many days of impairment in daily activities they had experienced in the last 4 weeks.|Baseline and Months 6, 18, 24, and 30|Full analysis set (FAS) participants with available data at each time point.||percentage of participants|||Number
814177|NCT01078090|Secondary|Participants Assessment of Fatigue Over Time|Participants indicated their level of fatigue over the last 7 days on a visual analog scale (VAS) ranging from 0 (best) to 10 (worst) cm; lower scores indicate better patient status.|Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60|"Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. n indicates the number of participants with available data at each time point."||cm||Standard Deviation|Mean
814178|NCT01078090|Secondary|Participants Assessment of Pain Over Time|Participants indicated their level of pain over the last 7 days on a visual analog scale (VAS) ranging from 0 (best) to 10 (worst) cm; lower scores indicate better patient status.|Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60|"Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. n indicates the number of participants with available data at each time point."||cm||Standard Deviation|Mean
814180|NCT01078090|Secondary|Hannover Functional Questionnaire (FFbH) Over Time|A self-administered patient questionnaire used to assess patient function based on 18 questions. The numerically coded responses to the questions are added to provide a total patient score. The FFbH was calculated from this patient score by the following formula: FFbH = (patient score x 100) ÷ 2 (number of valid responses). The resulting FFbH score reflects the degree of remaining functional capacity where 0% indicates maximal impairment and 100% indicates maximal functional capacity.|Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60|"Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. n indicates the number of participants with available data at each time point."||units on a scale||Standard Deviation|Mean
814181|NCT01078090|Secondary|Swollen Joint Count (SJC) Over Time|Twenty-eight joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination.|Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60|"Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. n indicates the number of participants with available data at each time point."||swollen joints||Standard Deviation|Mean
814182|NCT01078090|Secondary|Tender Joint Count (TJC) Over Time|Twenty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination.|Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60|"Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. n indicates the number of participants with available data at each time point."||tender joints||Standard Deviation|Mean
814183|NCT01078090|Secondary|C-Reactive Protein (CRP) Levels Over Time|C-reactive protein (CRP) was measured from blood samples as a marker for inflammation. Higher levels are indicative of more inflammation. Normal concentration in healthy human serum is usually lower than 10 mg/L, slightly increasing with age.|Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60|"Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. n indicates the number of participants with available data at each time point."||mg/L||Standard Deviation|Mean
814184|NCT01078090|Secondary|Erythrocyte Sedimentation Rate (ESR) Over Time|Erythrocyte sedimentation rate (ESR) indirectly measures how much inflammation is in the body. A higher ESR is indicative of increased inflammation.|Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60|"Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. n indicates the number of participants with available data at each time point."||mm/hour||Standard Deviation|Mean
814185|NCT01078090|Secondary|Percentage of Participants With Low, Moderate and High Disease Activity|"Low disease activity is defined as a DAS28 score ≤ 3.2; Moderate disease activity as a DAS28 >3.2 to ≤5.1; High disease activity as a DAS28 >5.1.
The Disease Activity Score (DAS28) is a validated index of rheumatoid arthritis disease activity calculated from the 28 tender joint count, 28 swollen joint count, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (measured on a visual analog scale [VAS] from 0 to 10 cm). Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity."|Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60|Full analysis set (FAS) participants with available data at each time point.||percentage of participants|||Number
814186|NCT01078090|Secondary|Percentage of Participants With a Significant Therapeutic Response|"Significant therapeutic response was determined by DAS28 critical difference (Dcrit). A Dcrit response is a statistically determined value that exceeds the threshold of random fluctuation and signifies a positive individual response during treatment. A DAS28-Dcrit individual therapeutic response is defined as a decrease (improvement) in DAS28 from Baseline of ≥ 1.8.
The Disease Activity Score (DAS28) is a validated index of rheumatoid arthritis disease activity calculated from the 28 tender joint count, 28 swollen joint count, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (measured on a visual analog scale [VAS] from 0 to 10 cm). Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity."|Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60|"Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. n indicates the number of participants with available data at each time point."||percentage of participants|||Number
814187|NCT01078090|Primary|Percentage of Participants in DAS28 Remission|Clinical remission is defined as a DAS28 score of < 2.6. The Disease Activity Score (DAS28) is a validated index of rheumatoid arthritis disease activity calculated from the 28 tender joint count, 28 swollen joint count, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (measured on a visual analog scale [VAS] from 0 to 10 cm). Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity.|Months 3, 6, 12, 18, 24, 30, 36, 48, and 60|"Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. n indicates the number of participants with available data at each time point."||percentage of participants|||Number
814188|NCT01078090|Primary|Change From Baseline in Disease Activity Score (DAS) 28|"The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR), and general health (measured on a visual analog scale [VAS] from 0 to 10 cm) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10.
A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission."|Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60|"Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. n indicates the number of participants with available data at each time point."||units on a scale||Standard Deviation|Mean
814189|NCT01078116|Primary|Cost-Utility Relationship of Rheumatoid Arthritis Patients Treated With Adalimumab Using Incremental Cost-Effectiveness Approach (ICER)|The ICER calculation is based on comparison of differences in costs and utilities (based on Quality of Life Adjusted years [QALYs]) between Baseline and the 12 month visit. The ICER represents the extra costs that have to be incurred for one extra unit of perfect health to be produced. A treatment is determined to be cost-effective if the ICER is below a certain threshold (National Health Systems of European Union have suggested a threshold of 50,000 euros).|12 months|Cost-utility analysis is based on the 76 participants who completed the study through 12 months.||Euros|||Number
815075|NCT01096680|Secondary|KSS Scores by Timepoint|The KSS is a 9-point scale on which the subject rates sleepiness from 1 (very alert) to 9 (very sleepy/fighting sleep). Lower score is better.|Over a period of 15 hours|FAS||Units on a scale||Standard Error|Least Squares Mean
814190|NCT01078116|Primary|Health Related Quality of Life (Medical Outcome Study Short Form 36)|Medical Outcome Study Short Form 36 (MOS SF-36) is a generic health related quality of life assessment that consists of 36 questions within 8 domains. Results from each domain are summarized and transformed into a scale ranging from 0 (worst) to 100 (best).|Enrollment visit (Baseline), month 3, month 6, month 12|Analysis is based on the number of participants completing the assessment at each time point.||Units on a scale||Standard Deviation|Mean
814191|NCT01078116|Primary|Health Related Quality of Life (Health Assessment Questionnaire)|Health Assessment Questionnaire (HAQ) is designed to assess patients’ abilities to perform activities of daily living. Scores range between 0 and 3, where higher values represent worse outcomes.|Enrollment visit (Baseline), month 3, month 6, month 12|Analysis is based on the number of participants completing the assessment at each time point.||units on a scale||Standard Deviation|Mean
814192|NCT01078116|Primary|Health Related Quality of Life (European Quality of Life 5 Dimensions)|European Quality of Life 5 Dimensions (EQ-5D) is a generic health related quality of life instrument which assesses 5 health dimensions on a scale of 1 (no problems) to 5 (worst health). An overall score is derived ranging from -.59 to +1; a higher score indicates better health.|Enrollment visit (Baseline), month 3, month 6, month 12|Analysis is based on the number of participants completing the assessments at each visit.||Units on a scale||Standard Deviation|Mean
814193|NCT01078116|Primary|Estimation of the Direct and Indirect Cost Incurred by Adalimumab Treatment|Direct and indirect per-participant costs were estimated at Baseline (enrollment visit) for the 3-month period prior to initiation of adalimumab treatment, and at 3, 6 and 12 months following initiation of treatment. Direct costs included pharmaceutical costs, diagnostic and monitoring test costs, hospitalization costs, rheumatologist's costs, social insurance rheumatologist's costs, other specialists costs, physiotherapy costs, rehabilitation cost, home care cost, equipment cost and transportation cost. Indirect costs refer to loss of income due to rheumatoid arthritis disability.|Enrollment visit (Baseline), month 3, month 6, month 12|Analysis is based on the number of participants completing the assessments at each visit.||Euros||Standard Deviation|Mean
814194|NCT01078155|Secondary|Erythrocyte Sedimentation Rate (ESR) at Baseline, Month 3, Month 12, Month 24|ESR was recorded as per local clinical practice. Normal findings are up to 20 mm/hr for females and up to 15 mm/hr for males.|Baseline (Day 0), Month 3, Month 12, Month 24|Per-Protocol Set: all participants who participated in every study visit; n=participants with evaluable data at time point.||mm/1 hour||Standard Deviation|Mean
814195|NCT01078155|Secondary|Visual Analogue Scale (VAS): Subject’s Assessment of Pain at Baseline, Month 3, Month 12, Month 24|Subject’s Assessment of Pain VAS was reported on a 100 mm scale, where 0 = no pain through 100 = severe pain.|Baseline (Day 0), Month 3, Month 12, Month 24|Per-Protocol Set: all participants who participated in every study visit; n=participants with evaluable data at time point.||units on a scale||Standard Deviation|Mean
814196|NCT01078155|Secondary|Visual Analogue Scale (VAS): Subject’s Global Assessment of Disease Activity at Baseline, Month 3, Month 12, Month 24|Subject’s Global Assessment of Disease Activity VAS was reported on a 100 mm scale, reporting the subject's evaluation of his/her difficulties as 0 = without any difficulty to 100 = significant difficulties.|Baseline (Day 0), Month 3, Month 12, Month 24|Per-Protocol Set: all participants who participated in every study visit; n=participants with evaluable data at time point.||units on a scale||Standard Deviation|Mean
814197|NCT01078155|Primary|Tender Joint Count at Baseline, Month 3, Month 12, and Month 24|The investigator counted the number of tender joints at each study visit (28 joints are routinely examined).|Baseline (Day 0), Month 3, Month 12, Month 24|Per-Protocol Set: all participants who participated in every study visit; n=participants with evaluable data at time point.||joints||Standard Deviation|Mean
814198|NCT01078155|Primary|Mean Duration of Morning Stiffness at Baseline, Month 3, Month 12, and Month 24|"Participant-reported the existence and duration of morning stiffness, defined as morning stiffness in and around the joints, lasting at least 1 hour before maximal improvement."|Baseline (Day 0), Month 3, Month 12, Month 24|Per-Protocol Set: all participants who participated in every study visit; n=participants with evaluable data at time point.||minutes||Standard Deviation|Mean
814199|NCT01078155|Primary|Change in Bone Turnover Marker C-telopeptide of Type I Collagen (CTX-I) From Baseline Through Month 3, Month 12, and Month 24||Baseline (Day 0), Month 3, Month 12, Month 24|Per-Protocol Set: all participants who participated in every study visit; n=participants with bone turnover markers at time point.||µg/L||Standard Deviation|Mean
814200|NCT01078155|Secondary|Visual Analogue Scale (VAS): Physician’s Global Assessment of Disease Activity at Baseline, Month 3, Month 12, Month 24|Physician’s Global Assessment of Disease Activity VAS was reported on a 100 mm scale, where 0 = very good to 100 = very bad.|Baseline (Day 0), Month 3, Month 12, Month 24|Per-Protocol Set: all participants who participated in every study visit, with evaluable data at time points.||units on a scale||Standard Deviation|Mean
814201|NCT01078155|Secondary|Disease Activity Score in 28 Joints (DAS28) at Baseline, Month 3, Month 12, Month 24|Scores on the DAS28 range from 0 to 10. DAS 28 ≥ 5.1= high RA disease activity; DAS 28 ≥ 3.2 = middle RA disease activity; DAS 28 ≤ 3.2 = lower disease activity; DAS 28 ≤ 2.6 = remission of disease.|Baseline (Day 0), Month 3, Month 12, Month 24|Per-Protocol Set: all participants who participated in every study visit; n=participants with evaluable data at time point.||units on a scale||Standard Deviation|Mean
814202|NCT01078155|Secondary|Swollen Joint Count at Baseline, Month 3, Month 12, and Month 24|The investigator counted the number of swollen joints at each study visit (28 joints are routinely examined).|Baseline (Day 0), Month 3, Month 12, Month 24|Per-Protocol Set: all participants who participated in every study visit; n=participants with evaluable data at time point.||joints||Standard Deviation|Mean
814203|NCT01078155|Primary|Change in Bone Turnover Marker C-terminal Type I Procollagen Peptide (CICP) From Baseline Through Month 3, Month 12, and Month 24||Baseline (Day 0), Month 3, Month 12, Month 24|Per-Protocol Set: all participants who participated in every study visit; n=participants with bone turnover markers at time point.||ng/mL||Standard Deviation|Mean
814204|NCT01078155|Primary|Change in Bone Turnover Marker Osteocalcin (OC) From Baseline Through Month 3, Month 12, and Month 24||Baseline (Day 0), Month 3, Month 12, Month 24|Per-Protocol Set: all participants who participated in every study visit; n=participants with bone turnover markers at time point.||µg/L||Standard Deviation|Mean
815076|NCT01096680|Secondary|Karolinska Sleepiness Scale (KSS) Scores|The KSS is a 9-point scale on which the subject rates sleepiness from 1 (very alert) to 9 (very sleepy/fighting sleep). Lower score is better.|Over a period of 15 hours|FAS||Units on a scale||Standard Error|Least Squares Mean
814205|NCT01078155|Primary|Spine and Hip T-score and Z-score by DEXA at Baseline, Month 12, and Month 24|T-score and Z-score of spine and hip (L1-L4 and proximal femur) by DEXA. T-score is the number of standard deviations that bone density is above or below the average. A score of ≥ -1 = normal bone density; < -1 and > -2.5 = a sign of osteopenia (bone density below normal); ≤ -2.5 = a sign of osteoporosis. Z-score is the number of standard deviations above or below what's normally expected for someone of matching age, sex, weight, and ethnic or racial origin. A Z-score ≤ -2 may suggest abnormal bone loss due to conditions other than aging.|Baseline (Day 0), Month 12, Month 24|Per-Protocol Set: all participants who participated in every study visit; n=participants with evaluable data at time point.||standard deviations||Standard Deviation|Mean
814206|NCT01078155|Primary|Bone Mineral Density (BMD) of Spine and Hip by Dual-energy X-ray Absorptiometry (DEXA) at Baseline, Month 12, and Month 24|BMD of spine and hip (L1-L4 and proximal femur) by DEXA, evaluated according to standard clinical guidelines.|Baseline (Day 0), Month 12, Month 24|Per-Protocol Set: all participants who participated in every study visit; n=participants with evaluable data at time point.||g/cm^2||Standard Deviation|Mean
814207|NCT01078207|Secondary|Relationship Between the Oxygen Desaturation Patterns and Repetitive Reductions in Nasal Airflow as Measured by Inductance Plethysmography and Nasal Pressure.|The number of patients with a positive repetitive reduction in nasal airflow which correlates with positive oxygen desaturation pattern as measured by photoplethysmography sensors.|12 hours after discharge form the recovery room|All patients with a positive repetitive reduction in nasal airflow.||participants|||Number
814208|NCT01078207|Primary|Presence of Repetitive Reductions in Nasal Airflow Patterns in the Pulse Oximetry Saturation Trend Data.|Number of patients exhibiting the presence of repetitive reductions in airflow patterns in the pulse oximetry trend data collected on subjects|12 hour after released from the recovery room|All patients with complete data were analyzed.||participants|||Number
814209|NCT01078220|Primary|Incidence Rate of Cellulitis|Cellulitis was defined as the presence of a cellulitis or abscess diagnosis code in the emergency room or hospital setting in the vaccination risk period or in the post-vaccination self-comparison period. These codes could have represented a new event, a pre-existing event, a prior history of the event, a “rule out” diagnosis, miscoding, or a misdiagnosis. Consistent with the study's design, diagnosis codes for general safety analyses were not confirmed in this study.|Within 14 days and within 60 days immediately after each vaccination|||Rate per 1000 person years|||Number
814210|NCT01078220|Secondary|Number of Cases of New Onset Autoimmune Conditions in Females Receiving at Least One Dose of Gardasil|"Autoimmune cases were defined as newly diagnosed cases within 6 months after any
dose of Gardasil, as confirmed by medical record review by panels of physicians specializing in the 16 autoimmune conditions of interest."|within 6 months immediately after each vaccination|Number of females with at least 12 months' membership at a MCO prior to Gardasil.||Number of autoimmune cases|||Number
814211|NCT01078220|Secondary|Number of Miscarriages Among Females Who Received Gardasil During Pregnancy|Pregnancy exposure was defined as receipt of Gardasil at any time from 1 month prior to conception through end of pregnancy.|First dose of Gardasil in pregnancy up to pregnancy resolution|Number of females potentially exposed to Gardasil during potential pregnancy as identified from unconfirmed diagnosis codes in electronic medical records.||Number of miscarriages|||Number
814212|NCT01078220|Secondary|Number of Congenital Anomalies Among Females Who Received Gardasil During Pregnancy|Pregnancy exposure was defined as receipt of Gardasil at any time from 1 month prior to conception through end of pregnancy.|First dose of Gardasil in pregnancy up to 6 months after birth|Number of females potentially exposed to Gardasil during potential pregnancy as identified from unconfirmed diagnosis codes in electronic medical records.||Number of congenital anomalies|||Number
814213|NCT01078220|Primary|Incidence Rate of Syncope|Syncope was defined as the presence of a syncope diagnosis code in the emergency room or hospital setting in the vaccination risk period or in the post-vaccination self-comparison period. These codes could have represented a new event, a pre-existing event, a prior history of the event, a “rule out” diagnosis, miscoding, or a misdiagnosis. Consistent with the study's design, diagnosis codes for general safety analyses were not confirmed in this study.|On day of each vaccination|||Rate per 1000 person years|||Number
814214|NCT01078233|Primary|Incidence of All-Cause Mortality|All participant deaths were recorded|Historical Cohort: up to 24 months (January 2006 to December 2007); Raltegravir and Concurrent Cohorts: up to 68 months (December 2007 to July 2013)|Intention-to-Treat analysis included follow-up until the end of the follow-up period for the cohort, regardless of whether or not raltegravir or other drugs were discontinued.||Events per 100 person-years of follow-up|Person years of follow-up|95% Confidence Interval|Number
814215|NCT01078233|Primary|Incidence of Lipodystrophy|Lipodystrophy events were defined as the first report for either 1) loss of fat from extremities, buttocks, or face, or 2) accumulation of fat in abdomen, neck, breasts, or other defined location.|Historical Cohort: up to 24 months (January 2006 to December 2007); Raltegravir and Concurrent Cohorts: up to 68 months (December 2007 to July 2013)|Intention-to-Treat analysis included follow-up until the end of the follow-up period for the cohort, regardless of whether or not raltegravir or other drugs were discontinued.||Events per 100 person-years of follow-up|Person years of follow-up|95% Confidence Interval|Number
814216|NCT01078233|Primary|Incidence of Clinically Important Hepatic Events|Clinically important hepatic events were defined as either 1) hepatic encephalopathy (stage III or IV), or 2) discontinuation of raltegravir use where liver toxicity was listed as the reason for discontinuation.|Historical Cohort: up to 24 months (January 2006 to December 2007); Raltegravir and Concurrent Cohorts: up to 68 months (December 2007 to July 2013)|Intention-to-Treat analysis included follow-up until the end of the follow-up period for the cohort, regardless of whether or not raltegravir or other drugs were discontinued.||Events per 100 person-years of follow-up|Person years of follow-up|95% Confidence Interval|Number
814217|NCT01078233|Primary|Incidence of Malignancy|All-type malignancy, including both Acquired Immune Deficiency Syndrome (AIDS)-defining and non-AIDS-defining malignancy, was evaluated. Only the first occurrence of any malignancy type was counted for each participant.|Historical Cohort: up to 24 months (January 2006 to December 2007); Raltegravir and Concurrent Cohorts: up to 68 months (December 2007 to July 2013)|Intention-to-Treat analysis included follow-up until the end of the follow-up period for the cohort, regardless of whether or not raltegravir or other drugs were discontinued.||Events per 100 person-years of follow-up|Person years of follow-up|95% Confidence Interval|Number
814218|NCT01078246|Secondary|Incidence of All-cause Mortality|All-cause mortality occurring during the risk period was identified through the use of computer-stored records of Emergency Department visits, hospitalizations, and state death certificates. Deaths were identified from administrative Kaiser Permanente databases, including Kaiser Permanente regional research and respective state(s) mortality files as well as the Social Security Administrative files. Incidence is reported as unadjusted, crude rates.|Historical Cohort: up to 33 months (January 2005 to October 2007); Raltegravir and Concurrent Cohorts: up to 69 months (October 2007 to June 2013)|The analysis includes all eligible participants.||Events per 1000 person-years of followup||95% Confidence Interval|Number
814219|NCT01078246|Secondary|Incidence of Clinically Important Cardiovascular Events|Significant cardiovascular events occurring during the risk period were identified through the use of computer-stored records and defined as inpatient events based on algorithms that utilize a combination of diagnosis and/or procedure codes. The identification of potential significant cardiovascular events was based on the occurrence of major adverse cardiovascular events (MACE) which include acute myocardial infarction (MI), ischemic stroke, unstable angina, revascularization (e.g. percutaneous coronary intervention (PCI) and coronary bypass graft surgery (CABG)), and cardiovascular death. Incidence is reported as unadjusted, crude rates.|Historical Cohort: up to 33 months (January 2005 to October 2007); Raltegravir and Concurrent Cohorts: up to 69 months (October 2007 to June 2013)|The analysis includes all eligible participants.||Events per 1000 person-years of followup||95% Confidence Interval|Number
814220|NCT01078246|Primary|Incidence of Lipodystrophy|Lipodystrophy (e.g. lipoatrophy, facial wasting) occurring during the risk period was identified through the use of computer-stored records of outpatient visits, Emergency Department visits and hospitalizations. The identification of potential lipodystrophy was based on two coded diagnoses codes indicative of lipodystrophy appearing at least 6 months apart over the course of patient care, the identification of interventions to treat such conditions (e.g. sculptra therapy), or procedural codes for Computerized Tomography indicating incident neck or abdominal lipoaccumulation. Incidence is reported as unadjusted, crude rates.|Historical Cohort: up to 33 months (January 2005 to October 2007); Raltegravir and Concurrent Cohorts: up to 69 months (October 2007 to June 2013)|The analysis includes all eligible participants.||Events per 1000 person-years of followup||95% Confidence Interval|Number
814221|NCT01078246|Primary|Incidence of Clinically Important Muscle Events|Significant muscle events (e.g. rhabdomyolysis) occurring during the risk period were identified through the use of computer-stored records of laboratory values, outpatient visits, Emergency Department visits and hospitalizations. The identification of potential significant muscle events was based on algorithms utilizing a combination of diagnoses, procedures and/or laboratory results for creatinine kinase. The number of muscle events did not meet the threshold for statistical analysis per protocol. Incidence is reported as unadjusted, crude rates.|Historical Cohort: up to 33 months (January 2005 to October 2007); Raltegravir and Concurrent Cohorts: up to 69 months (October 2007 to June 2013)|The analysis includes all eligible participants.||Events per 1000 person-years of followup||95% Confidence Interval|Number
814222|NCT01078246|Primary|Incidence of Clinically Important Skin Events|Significant skin events (e.g. Stevens-Johnson syndrome and toxic epidermal necrolysis) occurring during the risk period were identified through the use of computer-stored records of outpatient visits, Emergency Department visits and hospitalizations. The identification of potential significant skin events was based on algorithms utilizing a combination of diagnoses, procedures and/or medications. Surveillance of outpatient visits was limited to rashes coded as drug-related and requiring use of steroid (e.g. prednisone) administration. Incidence is reported as unadjusted, crude rates.|Historical Cohort: up to 33 months (January 2005 to October 2007); Raltegravir and Concurrent Cohorts: up to 69 months (October 2007 to June 2013)|The analysis includes all eligible participants.||Events per 1000 person-years of followup||95% Confidence Interval|Number
814223|NCT01078246|Primary|Incidence of Clinically Important Hepatic Events|Hepatic events occurring during the risk period were identified through computer-stored records of laboratory values, outpatient visits, Emergency Department visits, and hospitalizations. Significant hepatic events were identified based on algorithms utilizing a combination of diagnoses, procedures, and laboratory results. Incidence is reported as unadjusted, crude rates.|Historical Cohort: up to 33 months (January 2005 to October 2007); Raltegravir and Concurrent Cohorts: up to 69 months (October 2007 to June 2013)|The analysis includes all eligible participants.||Events per 1000 person-years of followup||95% Confidence Interval|Number
814224|NCT01078246|Primary|Incidence of AIDS-defining and Non-AIDS-defining Malignancy|All new malignancies occurring during the risk period, including Acquired Immune Deficiency Syndrome (AIDS)-defining and non-AIDS-defining malignancies, were identified through the Kaiser Permanente cancer registries. The registry data was supplemented by the use of computer-stored records of outpatient visits, Emergency Department visits and hospitalizations to identify cancers that would not be captured through the cancer registries (e.g. cutaneous Kaposi’s sarcoma).The AIDS-defining malignancies reported for any cohort were invasive cervical cancer, Kaposi's sarcoma, and non-Hodgkin lymphoma. Incidence is reported as unadjusted, crude rates.|Historical Cohort: up to 33 months (January 2005 to October 2007); Raltegravir and Concurrent Cohorts: up to 69 months (October 2007 to June 2013)|The analysis includes all eligible participants.||Events per 1000 person-years of followup||95% Confidence Interval|Number
814225|NCT01078298|Other Pre-specified|Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)|C-SSRS assessed if participant experienced following: completed suicide (1), suicide attempt (2)(response of “Yes” on “actual attempt”), preparatory acts toward imminent suicidal behavior (3)(“Yes” on “preparatory acts or behavior”), suicidal ideation (4)(“Yes” on “wish to be dead”, “non-specific active suicidal thoughts”, “active suicidal ideation with methods without intent to act or some intent to act, without or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7)(“Yes” on “Has participant engaged in non-suicidal self-injurious behavior”).|Baseline, Week 1 up to 30 days after Week 12 (treatment-emergent [TE]), thereafter up to Week 52 (follow-up [FU])|Safety analysis population included all participants who took at least 1 dose of randomized study medication, including partial doses, and had a safety measurement.||participants|||Number
814254|NCT01078376|Primary|Maximum Observed Plasma Concentration (Cmax) for TAK-536|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Day 1|Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.||ng/mL||Standard Deviation|Mean
814226|NCT01078298|Other Pre-specified|Change From Baseline in Barratt Impulsiveness Scale (BIS-11) - Total Score|The BIS-11 is a self-administered 30 items questionnaire to assess measure of impulsivity. Items are scored on a 4-point scale ranging from 1 (rarely/never) to 4 (almost always/always). Total score range from 30 to 120. Barratt suggested that a total score of greater than or equal to 75 could indicate an impulse-control disorder, whereas a total score in the range of 70 to 75 could indicate pathological impulsivity.|Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16|Safety analysis population included all participants who took at least 1 dose of randomized study medication, including partial doses, and had a safety measurement. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.||Units on a scale||Standard Deviation|Mean
814227|NCT01078298|Other Pre-specified|Change From Baseline in Hamilton Anxiety Scale (HAM-A) - Total Score|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); possible range 0 to 56. Lower score indicates less affected. Change: mean score at observation minus mean score at baseline.|Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16|Safety analysis population included all participants who took at least 1 dose of randomized study medication, including partial doses, and had a safety measurement. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.||Units on a scale||Standard Deviation|Mean
814228|NCT01078298|Other Pre-specified|Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score|Measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Change: mean score at observation minus mean score at baseline.|Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16|Safety analysis population included all participants who took at least 1 dose of randomized study medication, including partial doses, and had a safety measurement. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.||Units on a scale||Standard Deviation|Mean
814229|NCT01078298|Other Pre-specified|Number of Participants With Clinical Global Impression - Severity (CGI-S) Score|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected|Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16, 24, 32, 40, 52|Safety analysis population included all participants who took at least 1 dose of randomized study medication, including partial doses, and had a safety measurement. Here, the ‘n’ is signifying those participants who were evaluable for this measure at the specific categories for each arm group.||participants|||Number
814230|NCT01078298|Other Pre-specified|Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)|CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement from baseline is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected|Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16, 24, 32, 40, 52|Safety analysis population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' is signifying those participants who were evaluated for this measure at the time point for each group respectively.||participants|||Number
814231|NCT01078298|Other Pre-specified|Number of Participants With Adverse Events (Including Solicited Neuropsychiatric Adverse Events)|Adverse Event (AE):any untoward medical occurrence attributed to study drug in participant who received study drug.SAE:AE causing:death;initial/prolonged inpatient hospitalization;life-threatening experience(immediate risk of dying);persistent/significant disability/incapacity;congenital anomaly.Solicited AEs collected by semi-structured neuropsychiatric AEs interview inquiring about AEs:delusions,hallucinations,paranoia,psychosis,mania,panic,agitation,hostility,aggression,homicidal ideation. If participant had positive response,investigator determined if it met AE criteria.|Baseline up to Week 16|Safety analysis population included all participants who took at least 1 dose of randomized study medication, including partial doses, and had a safety measurement.||participants|||Number
814232|NCT01078298|Secondary|Number of Participants With 4-Week Point Prevalence (PP) of Abstinence|Number of participants at Week 52 visit reporting no smoking and no use of other tobacco products in the last 4 weeks confirmed by a measurement of an end-expiratory exhaled CO measurement less than or equal to 10 ppm.|Week 52|All participants analysis set included all the participants who were randomized and took at least one dose of randomized study medication.||participants|||Number
814233|NCT01078298|Secondary|Number of Participants With 7-day Point Prevalence (PP) of Abstinence|Number of participants reporting no use of nicotine-containing products in the last 7 days confirmed by a measurement of an end-expiratory exhaled CO measurement less than or equal to 10 ppm.|Weeks 12, 24, 52|All participants analysis set included all the participants who were randomized and took at least one dose of randomized study medication.||participants|||Number
814234|NCT01078298|Secondary|Percentage of Participants With Continuous Abstinence Rate (CAR)|Percentage of participants who remained abstinent from the period defined as start of the primary endpoint (Week 9) through Week 24 and the end of follow-up (Week 52) by reporting no use of nicotine-containing products confirmed by a measurement of an end-expiratory exhaled CO measurement less than or equal to 10 ppm.|Week 9 through Week 24, Week 9 through Week 52|All participants analysis set included all the participants who were randomized and took at least one dose of randomized study medication.||Percentage of participants|||Number
814235|NCT01078298|Primary|Percentage of Participants With a Four-Week Continuous Quit Rate (CQR)|"Percentage of participants who reported no use of nicotine-containing products by answering No to the nicotine use inventory (NUI) questions: ‘Has the participant smoked cigarettes’ and ‘Has the participant used other nicotine-containing products’ in the last 7 days (Week 9) or since last study visit (Week 9 through 12) confirmed by a measurement of an end-expiratory exhaled carbon monoxide (CO) measurement less than or equal to 10 parts per million (ppm)."|Week 9 through Week 12|All participants analysis set included all the participants who were randomized and took at least one dose of randomized study medication.||Percentage of participants|||Number
814255|NCT01078376|Primary|Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC[0-inf]) for TAK-536 Metabolite M-II|Area under the plasma concentration-time curve from time 0 to infinity, calculated as AUC(0-inf)=AUC(0-tlqc) + Clast/λz.|Day 1|Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.||ng.hr/mL||Standard Deviation|Mean
814236|NCT01078363|Secondary|Index of Microcirculatory Resistance at One Year Post Heart Transplant|The index of microcirculatory resistance (IMR) is a pressure-temperature sensor guidewire-based measurement, performed during cardiac catheterization, of the minimum microcirculatory resistance in a specific coronary artery. The IMR provides a quantitative measure of coronary microvasculature status.|one year|Only a subset of participants (adult patients enrolled at Stanford University) underwent index of microcirculatory resistance assessment.||mmHg x seconds||Standard Deviation|Mean
814237|NCT01078363|Secondary|Fractional Flow Reserve (FFR) at One Year Post Transplant|FFR is a technique used in coronary catheterization to measure pressure differences across a coronary artery stenosis (narrowing, usually due to atherosclerosis) to determine the likelihood that the stenosis impedes oxygen delivery to the heart muscle (myocardial ischemia). It is defined as the ratio of the distal coronary pressure to the proximal coronary pressure.|at one year post Transplant|Only a subset of participants (adult patients enrolled at Stanford University) underwent fractional flow reserve assessment.||Ratio||Standard Deviation|Mean
814238|NCT01078363|Secondary|The Percentage of Endothelial Progenitor Cells ( EPC) in Peripheral Blood in Patients One Year After Transplant|The determination of the percentage of EPC in peripheral blood involved surface staining peripheral blood mononuclear cells (PBMCs) with appropriate fluorescently-labeled antibodies to delineate EPCs from other blood cells, followed by analysis by conventional flow cytometry.|at one year|Not all blood samples obtained were adequate for EPC determination which explains the discrepancy in number of participants analyzed.||percentage of EPC||Standard Deviation|Mean
814239|NCT01078363|Secondary|ADMA Level at One Year Post Transplant|asymmetric dimethylarginine (ADMA), is an inhibitor of endothelial nitric oxide synthase which is a primary regulator of endothelial function.|1 year post Transplant|Blood samples were not acquired in all participants which accounts for the discrepancy in number of participants analyzed.||micromole||Standard Deviation|Mean
814240|NCT01078363|Secondary|Percentage of Participants With ≥20% Coronary Artery Diameter Reduction After Acetylcholine|The percent change in diameter of the left anterior descending artery was measured by quantitative angiography after acetylcholine and compared to baseline angiography. The percentage of participants who had ≥20% coronary artery diameter reduction after acetylcholine at one year is presented.|At Baseline and 1 Year|Only a subset of participants (those adult patients enrolled at Stanford University) underwent the acetylcholine measurements.||percentage of participants|||Number
814241|NCT01078363|Primary|Cardiac Allograft Vasculopathy(CAV) Defined as Change in IVUS-assessed Plaque Volume From Baseline to One Year|also called transplant coronary artery disease or cardiac transplant vasculopathy defined as coronary artery stenosis(narrowing) ranging from 30 to 70 percent by coronary angiography. Measured in this study as change in IVUS-assessed Plaque Volume from baseline to one year.|Baseline and 1 Year|||mm3/mm||Standard Deviation|Mean
814242|NCT01078376|Primary|Renal Clearance (CLr) From 0 to 24 Hours Postdose (for Cohorts 1 and 2 Urine Pharmacokinetic Endpoint for TAK-536 Metabolite M-II)|Renal clearance, calculated as CLr=Ae(0-24)/AUC(0-24).|Day 1|Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.||L/hr||Standard Deviation|Mean
814243|NCT01078376|Primary|Renal Clearance (CLr) From 0 to 24 Hours Postdose (for Cohorts 1 and 2 Urine Pharmacokinetic Endpoint for TAK-536)|Renal clearance, calculated as CLr=Ae(0-24)/AUC(0-24).|Day 1|Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.||L/hr||Standard Deviation|Mean
814244|NCT01078376|Primary|Fraction of Unchanged Drug Excreted in Urine From 0 to 24 Hours Postdose (Fe%) (for Cohorts 1 and 2 Urine Pharmacokinetic Endpoint for TAK-536 Metabolite M-II)|Fe=[Ae(0-24)/dose]×100 (molecular weight adjusted for metabolites.|Day 1|Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.||percent||Standard Deviation|Mean
814245|NCT01078376|Primary|Fraction of Unchanged Drug Excreted in Urine From 0 to 24 Hours Postdose (Fe%) (for Cohorts 1 and 2 Urine Pharmacokinetic Endpoint for TAK-536)|Fe=[Ae(0-24)/dose]×100 (molecular weight adjusted for metabolites.|Day 1|Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.||percent||Standard Deviation|Mean
814246|NCT01078376|Primary|Total Amount of Drug Excreted in Urine From Time 0 to 24 Hours Postdose (Ae[0-t]) (for Cohorts 1 and 2 Urine Pharmacokinetic Endpoint for TAK-536 Metabolite M-II)||Day 1|Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.||mg||Standard Deviation|Mean
814247|NCT01078376|Primary|Total Amount of Drug Excreted in Urine From Time 0 to 24 Hours Postdose (Ae[0-t]) (for Cohorts 1 and 2 Urine Pharmacokinetic Endpoint for TAK-536)||Day 1|Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.||mg||Standard Deviation|Mean
814248|NCT01078376|Primary|Apparent Oral Clearance (CL/F) for TAK-536|CL/F is apparent clearance of the drug from the plasma, expressed in L/hr.|Day 1|Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.||L/hr||Standard Deviation|Mean
814249|NCT01078376|Primary|Terminal Elimination Half-life (T1/2) for TAK-536 Metabolite M-II|Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.|Day 1|Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.||hr||Standard Deviation|Mean
814250|NCT01078376|Primary|Terminal Elimination Half-life (T1/2) for TAK-536|Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.|Day 1|Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.||hr||Standard Deviation|Mean
814251|NCT01078376|Primary|Time to Reach Cmax (Tmax) for TAK-536 Metabolite M-II|Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax, as observed on Day 1.|Day 1|Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.||hr||Full Range|Median
814252|NCT01078376|Primary|Time to Reach Cmax (Tmax) for TAK-536|Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax, as observed on Day 1.|Day 1|Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.||hr||Full Range|Median
814253|NCT01078376|Primary|Maximum Observed Plasma Concentration (Cmax) for TAK-536 Metabolite M-II|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Day 1|Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.||ng/mL||Standard Deviation|Mean
815113|NCT01097005|Secondary|Bacteriological Relapse Related to Duration of Clarithromycin Administration|Number of patients who have bacteriological relapse related to duration of Clarithromycin (CLR) administration after initial negative conversion|36 months|End of study (completers). Analysis of bacteriological relapse.||participants|||Number
814257|NCT01078376|Primary|Area Under the Plasma Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC[0-tlqc]) for TAK-536 Metabolite M-II.|AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]).|Day 1|Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.||ng.hr/mL||Standard Deviation|Mean
814258|NCT01078376|Primary|Area Under the Plasma Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC[0-tlqc]) for TAK-536|AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]).|Day 1|Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.||ng.hr/mL||Standard Deviation|Mean
814259|NCT01078389|Secondary|Mean Change From Baseline to Month 24 in the Modified Sharp/Van Der Heijde Total Score of the Single Affected Joint|The single affected joint was defined as the joint with the history of the first acute gout flare. Radiographs (X-rays) of the single affected joint in the hands or feet were evaluated using the modified Sharp/van der Heijde method. Each erosion was assessed using a 4-point scale where 0=no erosions (best) to 3=large erosion passing the mid-line (worst) and Joint space narrowing (JSN) was assessed using a 5-point scale where 0=normal (best) to 4=absence of joint space, presumptive evidence of ankyloses, or complete luxation (worst). The Erosion Score and the JSN Score were summed for the Total Score. Higher scores indicated more joint damage. A negative change from Baseline indicated improvement.|Baseline and Month 24|Full Analysis Set included all randomized participants who received at least one dose of study medication. Participants were analyzed according to the treatment group to which they actually received. Participants with data available at Baseline and Month 24 are included in the analysis.||score on a scale||Standard Deviation|Mean
814260|NCT01078389|Secondary|Mean Change From Baseline to Month 24 in the Rheumatoid Arthritis MRI Scoring System (RAMRIS) Score of the Single Affected Joint|The single affected joint was defined as the joint with the history of the first acute gout flare. Magnetic Resonance Imaging (MRI) was evaluated using the Rheumatoid Arthritis MRI Score (RAMRIS). Bone erosion in the proximal and distal location were each assessed in the affected joint using an 11-point scale where 0=no erosion (best) to 10=91-100% bone eroded (worst) for a bone erosion score range of 0 to 20. Bone marrow edema in the proximal and distal location were each assessed using a 4-point scale where 0=no edema (best) to 3=67-100% edema (worst) for a bone marrow edema (BME) score range of 0 to 6. Synovitis was assessed in the affected joint using a 4-point scale where 0=normal (best) to 3=severe (worst). Higher scores indicated more joint damage. A negative change from Baseline indicated improvement.|Baseline and Month 24|Full Analysis Set included all randomized participants who received at least one dose of study medication. Participants were analyzed according to the treatment group to which they actually received. Participants with data available at Baseline and Month 24 are included in the analysis.||score on a scale||Standard Deviation|Mean
814261|NCT01078389|Secondary|Mean Change From Baseline to Month 24 in the Modified Sharp/Van Der Heijde Erosion Scores From Full Hands and Feet Radiographs|Radiographs (X-rays) of 40 joints in the hands and 12 joints in the feet were evaluated using the modified Sharp/van der Heijde method. Each erosion was assessed using a 4-point scale where 0=no erosions (best) to 3=large erosion passing the mid-line (worst) for a total erosion score range of 0 to 320. Higher scores indicated more joint damage. A negative change from Baseline indicated improvement.|Baseline and Month 24|Full Analysis Set included all randomized participants who received at least one dose of study medication. Participants were analyzed according to the treatment group to which they actually received. Participants with data available at Baseline and Month 24 are included in the analysis.||score on a scale||Standard Deviation|Mean
814262|NCT01078389|Secondary|Mean Change From Baseline to Month 24 in the Modified Sharp/Van Der Heijde Total Scores From Full Hands and Feet Radiographs|Radiographs (X-rays) of 40 joints in the hands and 12 joints in the feet were evaluated using the modified Sharp/van der Heijde method. Each erosion was assessed using a 4-point scale where 0=no erosions (best) to 3=large erosion passing the mid-line (worst) for a total erosion score range of 0 to 320. Joint space narrowing (JSN) was assessed using a 5-point scale where 0=normal (best) to 4=absence of joint space, presumptive evidence of ankyloses, or complete luxation (worst) for a total JSN score range of 0 to 208. The Erosion Score and the JSN Score were combined for a total possible score of 0 to 528. Higher scores indicated more joint damage. A negative change from Baseline indicated improvement.|Baseline and Month 24|Full Analysis Set included all randomized participants who received at least one dose of study medication. Participants were analyzed according to the treatment group to which they actually received. Participants with data available at Baseline and Month 24 are included in the analysis.||score on a scale||Standard Deviation|Mean
814263|NCT01078389|Primary|Mean Change From Baseline to Month 24 in the Modified Sharp/Van Der Heijde Erosion Score of the Single Affected Joint|The single affected joint was defined as the joint with the history of the first acute gout flare. Radiographs (X-rays) of this single joint in the hands or feet were evaluated using the modified Sharp/van der Heijde method. Each erosion was assessed using a 4-point scale where 0=no erosions (best) to 3=large erosion passing the mid-line (worst). Individual erosion scores were summed to a maximum erosion score of 5 for joints in the hands and 10 for joints in the feet. Higher scores indicated more joint damage. A negative change from Baseline indicated improvement.|Baseline and Month 24|Full Analysis Set included all randomized participants who received at least one dose of study medication. Participants were analyzed according to the treatment group to which they actually received. Participants with data available for analysis and missing values at Month 24 imputed using linear extrapolation are included in the analysis.||score on a scale||Standard Deviation|Mean
814264|NCT01078402|Secondary|Tolerability: Overall Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Tolerability was measured by AEs and SAEs, collected during the course of the study. See the Reported Adverse Event section for details.|From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the last dose of physician-prescribed therapy. Mean (standard deviation [SD]) duration of therapy was 49.0 (16.0) weeks.|SES=participants fulfilling both of the following criteria: a primary diagnosis of specified rheumatic disease (RA, PsA, AS); at least one recorded Humira treatment is documented.||participants|||Number
814277|NCT01084551|Secondary|Average Duration of RLS Symptoms in the Evening and Night in a Week|Change of average duration of RLS symptoms in a week from baseline to the end of dose-titration/dose-maintenance period. Only the days with RLS symptoms are used for calculation.|Baseline, the end of dose-titration/dose-maintenance period (weeks 13)|FAS, LOCF||Hours||Standard Deviation|Mean
814265|NCT01078402|Secondary|Tolerability: Duration of Humira Therapy in Participants Who Discontinued Therapy|Tolerability was evaluated by assessing the mean duration (in weeks) of treatment with Humira until the development of an adverse event leading to treatment discontinuation or until early discontinuation for any other reason.|From first treatment until study discontinuation, up to 13 months.|Participants in the SES who discontinued therapy and had evaluable records. SES=participants fulfilling both of the following criteria: a primary diagnosis of specified rheumatic disease (RA, PsA, AS); at least one recorded Humira treatment is documented.||weeks||Standard Deviation|Mean
814266|NCT01078402|Secondary|Compliance With the Humira Administration Schedule at Month 13 (End of Study)|Compliance with the Humira therapy was assessed by the number of missed injections among participants. Documentation of injections missed or delayed by more than 7 days was made at each study visit.|Month 13|Participants in the SES with evaluable values. SES=participants fulfilling both of the following criteria: a primary diagnosis of specified rheumatic disease (RA, PsA, AS); at least one recorded Humira treatment is documented.||participants|||Number
814267|NCT01078402|Secondary|Participant Acceptability of Self-injection at Month 13 (End of Study)|Participant acceptability of self-injection was assessed by the percentage of participants able to appropriately execute self-injection after initial training in the medical center, per investigator’s opinion and documentation of necessity of re-training. Those participants able to self-inject also reported their experience of self-injection as convenient or inconvenient.|13 months|Participants in the SES with evaluable values. SES=participants fulfilling both of the following criteria: a primary diagnosis of specified rheumatic disease (RA, PsA, AS); at least one recorded Humira treatment is documented.||percentage of participants|||Number
814268|NCT01078402|Secondary|Physical Function: Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Baseline, and After 4, 7 and 13 Months of Humira Therapy|HAQ-DI score was calculated using the standard questionnaire covering 8 category scores: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Each category score is calculated as the maximum of the scores for the questions within the category. The HAQ-DI is expressed on a scale from 0 (without any difficulty) to 3 (unable to do) representing an average score across the category. Scores for at least 6 categories are needed to compute the HAQ score. Changes to lower scores indicate improvement in physical function.|Baseline, 4, 7 and 13 months|SES=participants fulfilling both of the following criteria: a primary diagnosis of specified rheumatic disease (RA, PsA, AS); at least one recorded Humira treatment is documented. n=number of participants with evaluable records at given time point.||units on a scale||Standard Deviation|Mean
814269|NCT01078402|Primary|Clinical Outcome (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] Decrease ≥50%) After 3 Months of Humira Therapy Relative to Baseline in Participants With PsA and AS|BASDAI score was calculated using a questionnaire with 6 questions that the participant completes by marking answers on a 10-centimeter visual analog scale with responses that range from 0 (none) to 10 (very severe) and measures severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 to 10. A positive clinical outcome was defined as a 50% or more decrease in BASDAI score after 3 months of Humira therapy relative to baseline.|Baseline, 3 months|Clinical Outcome Analysis Set (COS): all participants in the SES, who had a non-missing assessment of clinical outcome at baseline and not less than one follow-up visit with a non-missing assessment of clinical outcome. In addition, patients with unclear visit schedule were excluded from the COS.||participants|||Number
814270|NCT01078402|Primary|Clinical Outcome (Disease Activity Score [DAS28] Decrease ≥1.2) After 3 Months of Humira Therapy Relative to Baseline in Participants With RA|DAS28 score was calculated using the number of tender and swollen joints (out of 28 counted), erythrocyte sedimentation rate (ESR) level, and the participant's global assessment of disease activity. The calculated range of DAS28 is 0.49 to 9.07, with scores below 3.2 indicating low disease activity. A positive clinical outcome was defined as a DAS28 decrease by 1.2 or more after 3 months of Humira therapy relative to baseline.|Baseline, 3 months|Clinical Outcome Analysis Set (COS): all participants in the SES, who had a non-missing assessment of clinical outcome at baseline and not less than one follow-up visit with a non-missing assessment of clinical outcome. In addition, patients with unclear visit schedule were excluded from the COS.||participants|||Number
814271|NCT01084538|Secondary|Clinically Meaningful Hypercalcemia, Defined as Corrected Serum Calcium Greater Than 11.0 Milligrams Per deciLiter (mg/dL) Taken at Two Consecutive Measurements.|Number of participants with clinically meaningful hypercalcemia, defined as corrected serum calcium greater than 11.0 milligrams per deciLiter (mg/dL) taken at two consecutive measurements (visits) during the study.|Baseline through 12 months|Analysis was based on the number of subjects included in the full analysis set (N=175).||participants|||Number
814272|NCT01084538|Secondary|Time (Measured in Days) to Achieve Intact Parathyroid Hormone (iPTH) Levels Less Than or Equal to 300 pg/mL|The average time (measured in days) to achieve target iPTH levels.|Baseline through 12 months|Of the 175 participants in the full analysis set, one participant was excluded from the analysis due to missing data.||Days||Standard Deviation|Mean
814273|NCT01084538|Secondary|Percentage of Subjects Achieving Serum iPTH Level Less Than or Equal to 300 Picograms Per Milliliter (pg/mL)|Percentage of subjects achieving a serum iPTH level less than or equal to 300 pg/mL on the final visit.|Baseline through 12 months|Of the 175 participants in the full analysis set, one participant was excluded from the analysis due to missing data.||percentage of participants|||Number
814274|NCT01084538|Primary|Percentage of Subjects Achieving at Least a 40% Reduction of iPTH (Intact Parathyroid Hormone) From Baseline||Baseline through 12 months|Of the 175 participants in the full analysis set, one participant was excluded from the analysis due to missing data.||percentage of participants|||Number
814275|NCT01084551|Secondary|Average Sleep Time in a Week|Change of average sleep time in a week from baseline to the end of dose-titration/dose-maintenance period.|Baseline, the end of dose-titration/dose-maintenance period (weeks 13)|FAS, LOCF||Hours||Standard Deviation|Mean
814276|NCT01084551|Secondary|Nocturnal Awakenings Due to RLS Symptoms in a Week|Nocturnal awakening rate is calculated as the number of days with nocturnal awakenings / the number of days of evaluation * 100%.|Baseline, the end of dose-titration/dose-maintenance period (week 13)|FAS, LOCF||percentage of days/week with awakening||Standard Deviation|Mean
814278|NCT01084551|Secondary|Incidence of RLS Symptoms in the Evening and Night|Incidence rate of RLS symptoms is calculated as the number of days with RLS symptoms / the number of days of evaluation * 100%.|Baseline, the end of dose-titration/dose-maintenance period (week 13)|FAS, LOCF||percentage of days/week with symptoms||Standard Deviation|Mean
814281|NCT01084551|Secondary|Each Item of IRLS (10 Items)|"IRLS is a scale for assessing severity of restless legs syndrome symptoms. IRLS consists of ten questions. Each question is scored from 4 for the first (top) answer (usually 'very severe') to 0 for the last answer (usually none).
Numbers of subjects with -4 or -3 score change from baseline in each item of IRLS. A decrease in the scores means improvement."|Baseline, the end of dose-titration/dose-maintenance period (week 13)|FAS, LOCF||percentage of participants|||Number
814282|NCT01084551|Secondary|The Pittsburgh Sleep Quality Index (PSQI)|"Change of PSQI from baseline to the end of dose-titration/dose-maintenance period.
PSQI is a scale for assessing severity of sleep disorders. The score ranges from 0 to 21. 0 indicates “no difficulty” and 21 indicates “severe difficulty”. A decrease in the scores means improvement."|Baseline, the end of dose-titration/dose-maintenance period (week 13)|FAS, LOCF||Scores on a scale||Standard Deviation|Mean
814283|NCT01084551|Secondary|Patient Global Impression (PGI) Improvement|"PGI improvement is a patient-reported scale for assessing how much the patient's illness has improved or worsened from baseline.
The scale scoring criteria are 1: very much better, 2: much better, 3: a little better, 4: no change, 5: a little worse, 6: much worse, 7: very much worse."|Baseline, the end of dose-titration/dose-maintenance period (week 13)|FAS, LOCF||Percentage of Participants|||Number
814284|NCT01084551|Secondary|Clinical Global Impression (CGI) Improvement|"CGI improvement is a clinician-reported scale for assessing how much the patient's illness has improved or worsened from baseline.
The scale scoring criteria are 1: very much improved, 2: much improved, 3: minimally improved, 4: no change, 5: minimally worse, 6: much worse, 7: very much worse."|Baseline, the end of dose-titration/dose-maintenance period (week 13)|FAS, LOCF||Percentage of Participants|||Number
814285|NCT01084551|Primary|International Restless Legs Syndrome Rating Scale (IRLS) Total Score|"Change from the baseline to the end of dose-titration/dose-maintenance period. IRLS is a scale for assessing severity of restless legs syndrome symptoms. IRLS consists of ten questions. Each question is scored from 4 for the first (top) answer (usually ‘very severe’) to 0 for the last answer (usually none).
The sum of the score of each question serves as the scale score. The scale scoring criteria are: Mild (score 1-10); Moderate (score 11-20); Severe (score 21-30); Very severe (score 31-40). A decrease in the scores means improvement."|Baseline, the end of dose-titration/dose-maintenance period (week 13)|Full analysis set (FAS), last observation carried forward (LOCF)||Scores on a scale||Standard Deviation|Mean
814286|NCT01084603|Primary|Bioavailability|A measure of how much of the drug reaches a person’s bloodstream within a given period of time for the body to use. The extent of product bioavailability is estimated by the area under the blood concentration vs time curve. The area under the curve (AUC) is calculated by plotting the drug’s blood levels on a graph at different times during the set period to form a curve. The area under this curve reflects the amount of drug exposure in the set time period, calculated as hour*nanograms/milliliter (h*ng/ml).|12 hours|||h*ng/ml||Standard Deviation|Geometric Mean
814287|NCT01084603|Secondary|Released Nicotine|The amount of nicotine released from Nicorette® gum 4 mg during 30 minutes' chewing|After 30 minutes' chewing|ITT||(ng/ml)||Standard Deviation|Mean
814288|NCT01084603|Secondary|Terminal Elimination Rate Constant|The terminal nicotine elimination rate constant (Lamda z)|During 12 hours after start of administration|ITT||(1/hr)||Standard Deviation|Mean
814289|NCT01084603|Secondary|Time of Maximum Concentration|The time at which maximum concentration is reached (Tmax)|During 12 hours after start of administration|ITT||(hours)||Full Range|Median
814290|NCT01084603|Secondary|Nicotine Plasma Concentration|Area under the nicotine plasma concentration curve at 10 minutes (AUC10 min)|During 10 minutes after start of administration|ITT||(h*ng/ml)||Standard Deviation|Geometric Mean
814291|NCT01084603|Primary|Maximum Plasma Concentration|Cmax, which is the maximum (peak) concentration (amount of drug) measurable in blood plasma after a dose is administered measured in nanograms/milliliter (ng/ml)|During 12 hours after start of administration|ITT||(ng/ml)||Standard Deviation|Geometric Mean
814292|NCT01084668|Secondary|Tolerability and Safety Assessed by Collection and Classification of Adverse Reactions|Tolerability and safety were assessed by collecting adverse events during the course of the study up to 70 days following the last dose of physician-prescribed adalimumab. The number of participants experiencing a serious or non-serious adverse event is summarized. See the Reported Adverse Event section for details.|From the time of participant consent until 70 days after last dose of study drug|Analysis was performed on the All Treated population.||participants|||Number
814293|NCT01084668|Secondary|Nail Psoriasis Severity Index (NAPSI) Score|The nails are graded for nail matrix psoriasis and nail bed psoriasis. The sum of these two scores is the total score for that nail. Per nail, the NAPSI score ranges from 0 (no nail psoriasis) to 4 (most severe nail psoriasis).|Inclusion visit (Week 0), Week 4, Week 36, and Week 52|Analysis was performed using an observed case approach. For the All Treated population, NAPSI was assessed at Weeks 0, 4, 36, and 52 in 34, 30, 24, and 25 participants, respectively. For the Subgroup with nail psoriasis, NAPSI was assessed at Weeks 0, 4, 36, and 52 in 18, 16, 12, and 13 participants, respectively.||units on a scale||Standard Deviation|Mean
814294|NCT01084668|Secondary|Dermatology Life Quality Index (DLQI) Score|Dermatology Life Quality Index (DLQI) Score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. The DLQI score ranges from 0 (best) to 30 (worst).|Inclusion visit (Week 0), Week 4, Week 36, Week 52|Analysis was performed on the All Treated population using an observed case approach. DLQI score was assessed at Weeks 0, 4, 36, and 52 in 36, 34, 26, and 27 participants, respectively.||units on a scale||Standard Deviation|Mean
814295|NCT01084668|Primary|Reduction in Psoriasis Area and Severity Index Score of at Least 75% (PASI75)|PASI75 is the number of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 52 (final visit). PASI score is based on assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and area affected as observed on the day of examination. The score ranges from 0 (best outcome) to 72 (worst outcome).|Inclusion visit (Week 0) to Week 52|Analysis was performed on the All Treated population using an observed case approach. PASI response was assessed in 26 participants at Week 52.||participants|||Number
815268|NCT01097694|Secondary|Asthma Symptom Utility Index (ASUI)|Change in patient reported ASUI score The asthma symptom utility index (ASUI) is a 10-item weighted scale with a range from 0.2 to 1 with a higher value indicating improvement. The minimal important difference is 0.09.|6 months after start of treatment|||units on a scale||Standard Deviation|Mean
814296|NCT01084668|Primary|Psoriasis Area and Severity Index (PASI) Score|Psoriasis Area and Severity Index (PASI) score is based on assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and area affected as observed on the day of examination. The score ranges from 0 (best outcome) to 72 (worst outcome).|Inclusion visit (Week 0), Week 4, Week 36, Week 52|Analysis was performed on the All Treated population using an observed case approach. PASI score was assessed at Weeks 0, 4, 36, and 52 in 41, 36, 28, and 27 participants, respectively.||units on a scale||Standard Deviation|Mean
814300|NCT01086410|Secondary|Change From Baseline in Pulse Rate at Days 14, 28, 42, and Maximum Post-Baseline|Heart rate was measured at Baseline and at Days 14, 28, 42, and EW. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value. Scheduled, unscheduled, and early withdrawal visits were used for the maximum post-Baseline assessment.|Days 14, 28, 42, and EW|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||Beats per minute||Standard Deviation|Mean
814301|NCT01086410|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Days 14, 28, 42, and Maximum Post-Baseline|SBP and DBP were measured at Baseline and at Days 14, 28, 42, and EW. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value. Scheduled, unscheduled, and early withdrawal visits were used for the maximum post-Baseline assessment.|Days 14, 28, 42, and EW|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||Millimeters of mercury (mmHg)||Standard Deviation|Mean
814302|NCT01086410|Secondary|Change From Baseline in Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 42/EW|Blood samples were collected for the measurement of chloride, carbon dioxide (CO2) content/bicarbonate, glucose, potassium, sodium, and urea/blood urea nitrogen (BUN) at Baseline and Day 42/EW. For all laboratory assessments, Baseline is the most recent recorded value at Screening or prior to Day -1/1. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value.|Baseline and Day 42/EW|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||Millimoles per liter (mmol/L)||Standard Deviation|Mean
814303|NCT01086410|Secondary|Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine Values at Day 42/EW|Blood samples were collected for the measurement of direct bilirubin, indirect bilirubin, total bilirubin, and creatinine at Baseline and Day 42/EW. For all laboratory assessments, Baseline is the most recent recorded value at Screening or prior to Day -1/1. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value.|Baseline and Day 42/EW|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||Micromoles per liter (µmol/L)||Standard Deviation|Mean
814304|NCT01086410|Secondary|Change From Baseline in Albumin and Total Protein Values at Day 42/EW|Blood samples were collected for the measurement of albumin and total protein at Baseline and Day 42/EW. For all laboratory assessments, Baseline is the most recent recorded value at Screening or prior to Day -1/1. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value.|Baseline and Day 42/EW|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||Grams per liter||Standard Deviation|Mean
814315|NCT01086410|Secondary|Cmax for FF on Day 42|Cmax is defined as the maximum observed concentration on Day 42. Samples were collected at the following times: 0 (immediately pre-dose inhaled study drug); post-dose at 5 minutes (min), 15 min, 30 min, and 1 hour (hr), 2 hr, 4 hr, 9 hr, 12 hr, 16 hr, 20 hr, and 24 hr post-dose on Day 42.|Day 42|PK Population. Only those participants available at the specified time points were analyzed.||picograms per milliliter (pg/mL)||95% Confidence Interval|Geometric Mean
814305|NCT01086410|Secondary|Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) Values at Day 42/EW|Blood samples were collected for the measurement of ALT, ALP, AST, CK, and GGT at Baseline and Day 42/EW. For all laboratory assessments, Baseline is the most recent recorded value at Screening or prior to Day -1/1. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value.|Baseline and Day 42/EW|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||International units per liter (IU/L)||Standard Deviation|Mean
814306|NCT01086410|Secondary|Change From Baseline in Hematocrit Values at Day 42/EW|Blood samples were collected for the measurement of hematocrit at Baseline and Day 42/EW. For all laboratory assessments, Baseline is the most recent recorded value at Screening or prior to Day -1/1. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value.|Baseline and Day 42/EW|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Proportion of 1||Standard Deviation|Mean
814307|NCT01086410|Secondary|Change From Baseline in Hemoglobin Values at Day 42/EW|Blood samples were collected for the measurement of hemoglobin at Baseline and Day 42/EW. For all laboratory assessments, Baseline is the most recent recorded value at Screening or prior to Day -1/1. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value.|Baseline and Day 42/EW|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Grams per liter (g/L)||Standard Deviation|Mean
814308|NCT01086410|Secondary|Change From Baseline in Eosinophil, Total Neutrophil, Platelet, and White Blood Cell (WBC) Count Values at Day 42/EW|Blood samples were collected for the measurement of eosinophils, total neutrophils, platelets, and WBC count at Baseline and Day 42/EW. For all laboratory assessments, Baseline is the most recent recorded value at Screening or prior to Day -1/1. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value.|Baseline and Day 42/EW|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||10^9 cells per liter (GI/L)||Standard Deviation|Mean
814309|NCT01086410|Secondary|Change From Baseline in Basophil, Eosinophil, Lymphocyte, Monocyte, and Segmented Neutrophil Values at Day 42/Early Withdrawal (EW)|Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, and segmented neutrophils at Baseline and Day 42/EW. For all laboratory assessments, Baseline is the most recent recorded value at Screening or prior to Day -1/1. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value.|Baseline and Day 42/Early Withdrawal (EW)|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||Percentage||Standard Deviation|Mean
814310|NCT01086410|Secondary|Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in deciding whether reporting is appropriate in other situations. Refer to the General Adverse AE/SAE module for a complete list of AEs and SAEs.|From the start of study medication until Day 42 (Visit 5)/Early Withdrawal|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study drug.||Participants|||Number
814311|NCT01086410|Secondary|Tmax and Tlast of VI at Day 42|tmax is defined as the time to reach the observed maximum concentration, and tlast is defined as the time of the last observed quantifiable VI concentration on Day 42. Samples were collected at the following times: 0 (immediately pre-dose inhaled study drug); post-dose at 5 minutes (min), 15 min, 30 min, and 1hour (hr), 2 hr, 4 hr, 9 hr, 12 hr, 16 hr, 20 hr, and 24 hr post-dose on Day 42.|Day 42|PK Population. Only those participants available at the specified time points were analyzed.||hours||Full Range|Median
814312|NCT01086410|Secondary|Cmax for VI on Day 42|Cmax is defined as the maximum observed concentration on Day 42. Samples were collected at the following times: 0 (immediately pre-dose inhaled study drug); post-dose at 5 minutes (min), 15 min, 30 min, and 1 hour (hr), 2 hr, 4 hr, 9 hr, 12 hr, 16 hr, 20 hr, and 24 hr post-dose on Day 42.|Day 42|PK Population. Only those participants available at the specified time points were analyzed.||picograms per milliliter (pg/mL)||Standard Deviation|Mean
814313|NCT01086410|Secondary|AUC(0-t) for VI on Day 42|Area under the concentration-time (AUC[0-t]) curve from time zero (pre-dose) to the last time of quantifiable VI concentration on Day 42 was measured. Samples were collected at the following times: 0 (immediately pre-dose inhaled study drug); post-dose at 5 minutes (min), 15 min, 30 min, and 1 hour (hr), 2 hr, 4 hr, 9 hr, 12 hr, 16 hr, 20 hr, and 24 hr post-dose on Day 42.|Day 42|PK Population. Only those participants available at the specified time points were analyzed.||picograms*hour per milliliter (pg*hr/mL)||Standard Deviation|Mean
814314|NCT01086410|Secondary|Tmax and Tlast of FF at Day 42|tmax is defined as the time to reach the observed maximum concentration, and tlast is defined as the time of the last observed quantifiable concentration on Day 42. Samples were collected at the following times: 0 (immediately pre-dose inhaled study drug); post-dose at 5 minutes (min), 15 min, 30 min, and 1hour (hr), 2 hr, 4 hr, 9 hr, 12 hr, 16 hr, 20 hr, and 24 hr post-dose on Day 42.|Day 42|PK Population. Only those participants available at the specified time points were analyzed.||hours||Full Range|Median
824835|NCT01178268|Secondary|Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI||12 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
814316|NCT01086410|Secondary|AUC(0-t) and AUC(0-24) for FF on Day 42|Area under the plasma drug concentration-time (AUC[0-t]) curve from time zero (pre-dose) to the last time of quantifiable FF concentration and AUC(0-24) is the concentration time curve from zero (pre-dose) to 24 hours of quantifiable FF concentration on Day 42 was measured. AUC reflects the actual body exposure to drug over a specified period of time after administration of a dose. Samples were collected at the following times: 0 (immediately pre-dose inhaled study drug); post-dose at 5 minutes (min), 15 min, 30 min, and 1 hour (hr), 2 hr, 4 hr, 9 hr, 12 hr, 16 hr, 20 hr, and 24 hr post-dose on Day 42.|Day 42|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the PK Population.||picograms*hour per milliliter (pg*hr/mL)||95% Confidence Interval|Geometric Mean
814317|NCT01086410|Secondary|Plasma FF and VI Pharmacokinetic (PK) Concentration|Plasma FF and VI Pharmacokinetic (PK) Concentration were estimates at the following time points:0 (immediately pre-dose inhaled study drug), and post-dose at 5 min, 15 min, 30 min, and 1 hr, 2 hr, 4 hr, 9 hr, 12 hr, 16 hr, 20 hr, 24 hr on Day 42. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Pharmacokinetic Population.|Day 42|Pharmacokinetic (PK) Population: all participants in the ITT Population for whom a pharmacokinetic sample was obtained and analyzed.||picograms per milliliter (pg/mL)||Standard Deviation|Mean
814318|NCT01086410|Secondary|Ratio From Baseline of 0-24 Hour Urinary Free Cortisol Excretion on Day -1/1 (Baseline) and Day 42|A 24-hour urine sample was collected for the measurement of 24-hour urinary cortisol excretion at Day -1/1 (Baseline) and Day 42. Only those participants available at the specified time points were analyzed. Because values are on a logged scale, the ratio of the endpoint to Baseline is presented, as it is a measure of the difference from Baseline.|Day -1/1 (Baseline) and Day 42|Urine Cortisol (UC) Population: all participants in the ITT Population who did not have protocol deviations that were considered to affect the urine cortisol endpoint and whose urine samples were not considered to have confounding factors that would affect the interpretation of the results.||ratio from Baseline||Geometric Coefficient of Variation|Geometric Mean
814319|NCT01086410|Secondary|Ratio From Baseline of Serum Cortisol Trough (0-24 Hours) at Day -1/1 (Baseline) and Day 42|Serum cortisol trough is defined as the minimum value of serum cortisol measured over the 24-hour period. Samples were collected at the following times: 0 (immediately pre-dose inhaled study drug); post-dose at 5 minutes (min), 15 min, 30 min, and 1 hour (hr), 2 hr, 4 hr, 9 hr, 12 hr, 16 hr, 20 hr, and 24 hr. Because values are on a logged scale, the ratio of the endpoint to Baseline is presented, as it is a measure of the difference from Baseline.|Day -1/1 (Baseline) and Day 42|SC Population. Only those participants available at the specified time points were analyzed.||ratio from Baseline||Geometric Coefficient of Variation|Geometric Mean
814320|NCT01086410|Secondary|Ratio From Baseline of the Serum Cortisol Area Under the Concentration-time Curve (AUC) (0-24 Hour) on Day -1/1 (Baseline) and Day 42|Area under the plasma drug concentration-time (AUC[0-24 hour]) curve from time zero (pre-dose) to the last time of quantifiable serum cortisol concentration at 24 hours post-dose on Day -1/1 (Baseline) and Day 42 was measured. AUC reflects the actual body exposure to drug over a specified period of time after administration of a dose. Samples were collected at the following times: 0 (immediately pre-dose inhaled study drug); post-dose at 5 minutes (min), 15 min, 30 min, and 1 hour (hr), 2 hr, 4 hr, 9 hr, 12 hr, 16 hr, 20 hr, and 24 hr. Because values are on a logged scale, the ratio of the endpoint to Baseline is presented, as it is a measure of the difference from Baseline.|Day -1/1 (Baseline) and Day 42|SC Population. Only those participants available at the specified time points were analyzed.||ratio from Baseline||Geometric Coefficient of Variation|Geometric Mean
814321|NCT01086410|Primary|Ratio From Baseline of the Serum Cortisol Weighted Mean (0–24 Hours) on Day -1/1 (Baseline) and Day 42|"Serum cortisol weighted mean was determined for each participant over the time period 0–12 hours on Day -1/1 (Baseline) and Day 42. Serum cortisol weighted mean was derived by dividing the area under the concentration-time curve (AUC; defined as thearea under the concentration-time curve from time zero up to 24 hours) by the sample collection time interval. The sample collection time interval is defined as the difference between the time of the last cortisol sample and the time of the first cortisol sample. Samples were collected at the following time points: 0 (first blood draw/pre-dose); 2, 4, 9, 12, 14, 16, 20, 22, and 24 hours (relative to the 0 time point). Because values are on a logged scale, the ratio of the endpoint to Baseline is presented, as it is a measure of the difference from Baseline."|Day -1/1 (Baseline) and Day 42|Serum Cortisol (SC) Population: all participants in the Intent-to-Treat Population who did not have protocol deviations that were considered to affect the SC endpoint and whose serum samples were not considered to have confounding factors affecting results interpretation. Only those participant available at the specified time points were analzyed.||ratio from Baseline||Geometric Coefficient of Variation|Geometric Mean
814322|NCT01086423|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Month 0 to Month 4/5)|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.||Participants|||Count of Participants
814323|NCT01086423|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Days 0-30) post-vaccination period after any dose|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.||Participants|||Count of Participants
814855|NCT01085318|Secondary|Change in Volume (in Millimeters Cubed) of Normal Appearing Brain Tissue (NABT) With Decreasing (Indicative of Demyelination) Voxel-wise Magnetization Transfer Ratio (VW-MTR)From Baseline to 6 Months|To characterize the effect of Rebif on demyelination using VW-MTR dynamic mapping of NABT in subjects ith RRMS over 6 months of treatment compared to a group of healthy Control (HC).|Baseline to Month 6|||mm^3||Full Range|Median
814324|NCT01086423|Secondary|Number of Subjects With Any Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above 37.0 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade or relationship to study vaccination.|During the 4-day (Days 0-3) post-vaccination period after each vaccine dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented, who had their symptom sheets filled in.||Participants|||Count of Participants
814325|NCT01086423|Secondary|Number of Subjects With Any Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.|During the 4-day (Days 0-3) post-vaccination period after each vaccine dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented, who had their symptom sheets filled in.||Participants|||Count of Participants
814326|NCT01086423|Secondary|Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.|Before (Month 0) and one month after the third dose of study vaccine (Month 3 or Month 4)|The analysis was performed on the ATP cohort for immunogenicity, which included a subset of evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
814327|NCT01086423|Secondary|Anti-polio Types 1, 2 and 3 Antibody Titers|Antibody titers were presented as geometric mean titers (GMTs).|Before the first dose (Month 0) and one month after the third dose of study vaccine (Month 3 or Month 4)|The analysis was performed on the ATP cohort for immunogenicity, which included a subset of evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component were available.||Titers||95% Confidence Interval|Geometric Mean
814328|NCT01086423|Secondary|Anti-PRP Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in µg/mL.|Before the first dose (Month 0) and one month after the third dose of study vaccine (Month 3 or Month 4)|The analysis was performed on the ATP cohort for immunogenicity, which included a subset of evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component were available.||µg/mL||95% Confidence Interval|Geometric Mean
814329|NCT01086423|Secondary|Anti-D and Anti-T Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.|Before the first dose (Month 0) and one month after the third dose of vaccination (Month 3 or Month 4)|The analysis was performed on the ATP cohort for immunogenicity, which included a subset of evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component were available.||IU/mL||95% Confidence Interval|Geometric Mean
814330|NCT01086423|Primary|Number of Subjects With a Vaccine Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antibodies|"Vaccine response was defined as:
For PT and FHA response, antibody concentration ≥ 20 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL) at post-vaccination.
For PRN response: for initially seronegative subjects [antibody concentration lower than (<) 5 EL.U/mL], post-vaccination antibody concentration ≥ 20 EL.U/mL; for initially seropositive subjects (antibody concentration ≥ 5 EL.U/mL), at least a 4-fold increase in antibody concentration from pre to post-vaccination."|One month after the third vaccine dose (Month 3 or Month 4)|The analysis was performed on the ATP cohort for immunogenicity, which included a subset of evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component were available.||Participants|||Count of Participants
814331|NCT01086423|Primary|Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 Antigens|A seroprotected subject was defined as a subject with anti-poliovirus (anti-polio) types 1, 2 and 3 antibody titres ≥ the value of 8.|One month after the third vaccine dose (Month 3 or Month 4)|The analysis was performed on the ATP cohort for immunogenicity, which included a subset of evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component were available.||Participants|||Count of Participants
814332|NCT01086423|Primary|Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) Antigen|A seroprotected subject was defined as a subject with anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (μg/mL).|One month after the third vaccine dose (Month 3 or Month 4)|The analysis was performed on the ATP cohort for immunogenicity, which included a subset of evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component were available.||Participants|||Count of Participants
814333|NCT01086423|Primary|Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigens|A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).|One month after the third vaccine dose (Month 3 or Month 4)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included a subset of evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component were available.||Participants|||Count of Participants
814334|NCT01086475|Primary|Social Responsiveness Scale (SRS) at Follow-Up|"The 65-item SRS is a standardized measure of the core symptoms of autism. Each item is scored on a 4-point Likert scale. The score of each individual item is summed to create a total raw score. A total scores results are as follows:
0-62: Within normal limits 63-79: Mild range of impairment 80-108: Moderate range of impairment 109-149: Severe range of impairment"|Completed at Week 22|Each group included up to four children with ASD and two typically-developing peer models (TPs) in the same age group.||units on a scale||Standard Deviation|Mean
814370|NCT01087502|Secondary|Fasting Plasma Glucose (FPG) Change From Baseline to Week 12|This change from baseline reflects the Week 12 FPG minus the baseline FPG. Means are treatment-adjusted for baseline HbA1c, baseline FPG and prior use of insulin, week repeated within patient and week by treatment interaction.|Baseline and week 12|One patient in the Placebo/Glimepiride arm and one patient in the Linagliptin arm without FPG on-treatment value. Results do not contain data of patients from the excluded study site.||mg/dL||Standard Error|Mean
814335|NCT01086475|Secondary|Clinical Global Impressions Improvement Scale Responder Analysis|The CGI Global Improvement (CGI-I) is a clinician-rate scale designed to take into account all factors to arrive at an assessment of severity and response to treatment, including parent report, parent-rated measures, teacher-rated measures, and clinician-rated measures. The CGI-I is rated from 1 to 7 (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse) at a single time-point. The CGI-I was completed at each visit, but only at week 11 were those subjects classified as “much” or “very much improved” defined as responders and all other classifications will be regarded as non-responders.|Week 11|Each social skills group included up to four children with ASD and two typically-developing peer models (TPs) in the same age group.||percentage of participants|||Number
814336|NCT01086475|Primary|Social Responsiveness Scale (SRS) Change|"The 65-item SRS is a standardized measure of the core symptoms of autism. Each item is scored on a 4-point Likert scale. The score of each individual item is summed to create a total raw score. A total scores results are as follows:
0-62: Within normal limits 63-79: Mild range of impairment 80-108: Moderate range of impairment 109-149: Severe range of impairment"|Completed at Baseline and Week 11|Each group included up to four children with ASD and two typically-developing peer models (TPs) in the same age group.||units on a scale||Standard Deviation|Mean
814337|NCT01086605|Secondary|Toxicity|For this secondary endpoint, toxicity is defined as a grade 3 or higher adverse events that is classified as either possibly, probably, or definitely related to study treatment. The assignment of attribution to study treatment and grade (or degree of severity) of the adverse event are classified using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The number of participants reporting a grade 3 or higher toxicity is reported. For a list of all reported adverse events, please refer to the Adverse Events Section below.|Up to 1 year after treatment|||Participants|||Count of Participants
814338|NCT01086605|Secondary|Duration of Response|Duration of response is defined for all evaluable patients with measurable disease who have achieved a confirmed response as the date at which the patient’s earliest best objective status is first noted to be either a CR or PR to the earliest date progression is documented at each dose level. If a patient dies subsequent to the confirmed response without a documentation of disease progression, the patient will be considered to have had disease progression at the time of their death. In the case of a patient failing to return for evaluations before a documentation of disease progression, the patient will be censored for progression on the date of last evaluation. The distribution of duration of response will be estimated using the method of Kaplan-Meier at each dose level.|Up to 5 years|||months||Full Range|Mean
814339|NCT01086605|Secondary|Overall Survival Time|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier at each dose level.|Up to 5 years|||months||95% Confidence Interval|Median
814340|NCT01086605|Secondary|6-month Progression-free Survival Rate|The 6-month progression free survival (6-mo PFS) rate is the proportion of efficacy-evaluable patients progression-free 6 months from registration. The 6-mo PFS rate is defined as the total number of efficacy-evaluable patients on study without documentation of disease progression 6 months from registration divided by the total number of efficacy-evaluable patients enrolled on study. Patients who died without documentation of progression will be considered to have progressed on the date of their death. The true 6-mo PFS rate will be estimated by the proportion of efficacy-evaluable patients on study without documentation of disease progression 6 months from registration at each dose level. Binomial confidence intervals for 6-mo PFS rate will be constructed for each dose level. Progression is defined using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1).|At 6 months|||proportion||95% Confidence Interval|Number
814341|NCT01086605|Secondary|Time to Disease Progression|Time to disease progression is defined as the time from registration to the earliest date of documentation of disease progression. If a patient dies without a documentation of disease progression the patient will be considered to have had disease progression at the time of their death. If the patient is declared to be a major treatment violation, the patient will be censored on the date the treatment violation was declared to have occurred. In the case of a patient starting treatment and then never returning for any evaluations, the patient will be censored for progression one day post-registration. The distribution of time to progression will be estimated using the method of Kaplan-Meier at each dose level. Progression is defined using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1).|Up to 5 years|||months||95% Confidence Interval|Median
814342|NCT01086605|Primary|Proportion of Confirmed Tumor Responses (Complete or Partial Response)|The proportion of confirmed responses will be estimated by the number of women who achieve a CR or PR on two consecutive evaluations at least 6-8 weeks apart depending on the dose level. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients at each dose level. Confidence intervals for the true success proportion at each dose level will be calculated according to the approach of Duffy and Santner. Response will be evaluated in this study using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1); Complete Response (CR): Disappearance of all non-nodal target lesions, each target lymph node must have reduction in short axis to <1.0 cm. and normalization of tumor biomarkers. Partial Response (PR): At least a 30% decrease in the sum of the longest diameters of the non-nodal target lesions and the short axis of the target lymph nodes taking as reference the Baseline Sum of Diameters.|Up to 5 years|||proportion||95% Confidence Interval|Number
814343|NCT01086761|Secondary|Number of Participants With Positive Binding Anti-MP0112 Antibodies|Blood samples were collected Pre-treatment (Baseline) and Weeks 4, 8 and 12. Samples were analyzed for Anti-MP0112 antibodies using an enzyme-linked immunosorbent assay.|12 weeks|Safety Population included all treated participants.||Participants|||Number
814344|NCT01086761|Secondary|Maximum Serum Concentration (Cmax) of MP0112 at Day 3|Blood samples were collected for MP0112 levels on Day 3. The serum samples (liquid portion of the blood after cells and clotting factors were removed) were sent to a laboratory and were analyzed for MP0112 levels using an enzyme-linked immunosorbent assay. Maximum concentration at Day 3 was calculated.|Day 3|Pharmacokinetic (PK) Population included all treated participants with PK data.||Nanomolar (nM)|||Number
814915|NCT01085968|Secondary|Task Errors and Variability|Left, right and bimanual errors in external cue and internally generated tasks for four-digit trials|time of enrollment and 2 months following enrollment (before and after training)|||Number of Errors||Standard Deviation|Mean
814345|NCT01086761|Secondary|Area of Lesion as Measured by Fluorescein Angiography|Fluorescein angiography (FA) is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. Photographs are taken with a specialized low-power microscope with an attached camera designed to photograph the interior of the eye, including the retina and optic disc. FA was performed on the dilated study eye after fluorescein application at Baseline and Week 4. A lower number indicated a smaller lesion area.|Baseline, Week 4|All treated participants with data available for analysis.||mm^2||Standard Deviation|Mean
814346|NCT01086761|Secondary|Area of Leakage as Measured by Fluorescein Angiography|Fluorescein angiography (FA) is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. Photographs are taken with a specialized low-power microscope with an attached camera designed to photograph the interior of the eye, including the retina and optic disc. FA was performed on the dilated study eye 10 minutes after fluorescein application at Baseline and Week 4. A lower number indicated a smaller area of leakage.|Baseline, Week 4|All treated participants.||mm^2||Standard Deviation|Mean
814347|NCT01086761|Secondary|Change From Baseline in Central Area Retinal Thickness|Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed in the study eye after pupil dilation at Baseline and Week 4. A negative change from Baseline indicated improvement (less retinal thickness). A positive change from Baseline indicated worsening (definite retinal thickening).|Baseline, Week 4|All treated participants.||μm||Standard Deviation|Mean
814348|NCT01086761|Secondary|Percentage of Participants With Stable or Improved Best Corrected Visual Acuity (BCVA)|BCVA was measured using an eye chart and was reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye at Baseline and Week 4. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the letters read correctly on the eye chart the better the vision. Stable or Improved BCVA was defined as a loss of <15 letters read correctly compared to Baseline.|Baseline, Week 4|All treated participants.||Percentage of participants|||Number
814349|NCT01086761|Primary|Maximal Tolerated Dose (MTD) Following a Single Injection|MTD was defined as one dose level below the lower of the dose level in which a severe (sight-threatening) drug-related Adverse Event occurred or the dose level at which more than 2 patients experienced a moderate ocular (eye) drug-related toxicity.|16 weeks|All treated participants.||mg|||Number
814350|NCT01086852|Primary|Number of Participants With Degree of Bleeding Control Rated as Excellent.|"Investigators made an overall assessment of FACTOR X in controlling bleeding at the End of Treatment Assessment. The degree of bleeding control was rated as excellent, good, poor or unassessable, in accordance with the following criteria listed below:
Excellent -Parameters were similar to those in subjects without a bleeding disorder.
Good -Parameters were inferior to those in subjects without a bleeding disorder, but no other factor X containing agents were required to restore haemostasis.
Poor - Blood loss was excessive (defined as more than twice the pre defined amount that would be expected in a subject without a bleeding disorder for this type of surgery) and/or Haemostasis was not achieved and/or Additional factor X containing agents were required to restore haemostasis.
Unassessable -Efficacy was not possible to assess, or Additional factor X containing agents (excluding blood transfusions) were required before efficacy of FACTOR X could be assessed."|During and till end of treatment|The ITT population will be defined as all surgical procedures in which subjects were treated with at least one dose of FACTOR X and have undergone surgery.||Participants|||Number
814351|NCT01086852|Secondary|Dose Per Infusion (IU/kg)|weight adjusted dose per infusion until a subject was no longer at risk of bleeding due to surgery|before surgery, during the post operative period|The ITT population will be defined as all surgical procedures in which subjects were treated with at least one dose of FACTOR X and have undergone surgery.||IU/kg||Full Range|Median
814352|NCT01086852|Primary|Change of Haemoglobin From Pre-surgery Till End of Treatment|The subject’s haemoglobin was measured pre operatively, within 2 hours post operatively and at the End of Treatment Assessment. Changes in the subject’s haemoglobin from pre to post operatively and from post operatively to the End of Treatment Assessment were assessed, taking into account the volume of fluid infused into the subject during the intervening periods, any blood transfusions in the intervening periods, the subject’s haematocrit at the same time points and the subject’s pre dose serum ferritin|2 hrs pre-operatively till end of treatment|The ITT population will be defined as all surgical procedures in which subjects were treated with at least one dose of FACTOR X and have undergone surgery.||g/L||Standard Deviation|Geometric Mean
814353|NCT01086852|Primary|Number of Post Operative Bleeding Episodes (See Table Below)|Bleeding was assessed at least once each day by the investigator, more frequently if indicated by the severity of the operation or the subject’s response. This included all bleeding episodes from the end of the surgical procedure until the subject was no longer at risk of bleeding due to surgery|End of surgery till end of study|The ITT population will be defined as all surgical procedures in which subjects were treated with at least one dose of FACTOR X and have undergone surgery.||number of bleeds|||Number
814354|NCT01086852|Primary|Requirement for Blood Transfusion|Number of blood transfusions required (units of packed red blood cells or units of whole blood) or infusion of autologous red cells during and after surgery|during and after surgery|The ITT population will be defined as all surgical procedures in which subjects were treated with at least one dose of FACTOR X and have undergone surgery.||number of transfusions|||Number
814355|NCT01086852|Primary|Clinical Assessment of Blood Loss During Surgery Against the Volume of Blood Loss Expected in Patients Without a Bleeding Disorder.|The investigator's estimation of the volume of blood loss during surgery compared to the volume of blood loss expected in patients without a bleeding disorder undergoing the same surgical procedure and reported as greater than, equal to or less than.|After wound closure|All subjects treated with FACTOR X||participants|||Number
814356|NCT01086852|Secondary|Incremental Recovery After Bolus Dose of FACTOR X|"Incremental Recovery of FX:C after the Pre surgery Bolus Infusion The factor X increment is calculated by subtracting the pre-infusion factor X level from the post-dose value.
Incremental recovery is calculated by FX increment (IU/dL)/ FX dose (IU/kg)"|incremental recovery was assessed at approximately 30 minutes after the pre surgery bolus|The ITT population will be defined as all surgical procedures in which subjects were treated with at least one dose of FACTOR X and have undergone surgery.||IU/dL per IU/kg||Standard Deviation|Geometric Mean
814357|NCT01086852|Primary|Clinical Estimation of Volume of Blood Loss During Surgery|"As soon as possible after wound closure, the investigator estimated the volume of blood loss during surgery and made a clinical assessment against the volume of blood loss typically expected in a normal patient (i.e. one without a bleeding disorder and undergoing the same surgical procedure). The assessment may have been supported by a swab and pad count.
The clinical assessment was rated as follows:
Blood loss less than expected
Blood loss as expected
Blood loss more than expected
Blood loss excessive (defined as more than twice the pre defined amount that would be expected in a normal patient for this type of surgery)"|Blood loss is measured during and after surgery, the overall assessment is made after the last dose of FACTOR X.|The ITT population will be defined as all surgical procedures in which subjects were treated with at least one dose of FACTOR X and have undergone surgery.||ml||Standard Deviation|Geometric Mean
814358|NCT01086969|Primary|Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination|Solicited injection site: Pain, Erythema (Redness), and Swelling. Solicited Systemic reaction: Fever (Temperature), Headache, Malaise, and Myalgia|Day 0 to 7 post-vaccination|Safety parameters were assessed in the safety analysis set||Participants|||Number
814359|NCT01086969|Primary|Percentage of Participants With at Least a 4-fold Increase in Antibodies to Menactra Vaccine Antigens Post Vaccination|Antibodies to Menactra antigens determined by the serum bactericidal assay baby rabbit complement (SBA-BR) test.|Day 0 to 30 post-vaccination|Four-fold antibody increase were determined in the immunogenicity analysis set||Percentage of Participants|||Number
814360|NCT01086969|Primary|Serum Bactericidal Assay Baby Rabbit Complement (SBA BR) Geometric Mean Titers Before and Post Menactra Vaccination|Antibodies to Menactra antigens determined by the serum bactericidal assay baby rabbit complement (SBA-BR) test.|Day 0 and Day 30 post-vaccination|Geometric mean titers were determined in the immunogenicity analysis set||1/dilution (1/dil)||95% Confidence Interval|Geometric Mean
814361|NCT01086969|Primary|Number of Participants With Vaccine Antibody Titers at ≥ 8 Before and After Menactra Vaccination|Antibodies to Menactra vaccine were measured by the Serum bactericidal assay baby rabbit complement (SBA BR) Test.|Baseline and 21 days post-vaccination|Menactra vaccine antibody titers were determined in the immunogenicity analysis set.||Participants|||Number
814362|NCT01087489|Secondary|Presence and Severity of Keratopathy and the Size of Subconjunctival Hemorrhage|"Presence of corneal staining after the injection:
Quadrants of fluorescein staining: 0 1 2 3 4
Density of staining: 0- None 1- Mild 2- Moderate 3- Severe 4- corneal abrasion
Size of subconjunctival hemorrhage:
in clock hours"|within 10 minutes of the injection|all eyes for which data were available were included||units on a scale|Participants|Standard Deviation|Mean
814363|NCT01087489|Secondary|Intraocular Pressure Change After Intravitreal Injection With Each Anesthetic Method, Results Reported in mmHg|intraocular pressure (IOP) was measured immediately after the injection, and at 5, 10, and 15 minutes after the injection (until it was 30 mmHg or below). Prior to injection IOP and post-injection IOP were compared to find the IOP change after injection.|immediately after injection, at 5, 10, 15 minutes|48 participants were included in each arm, i.e. each participant received both methods, one eye twice if unilateral or both eyes if bilateral disease were randomily assigned to alternate prep on consecutive or same visit respectively||mmHg|Participants|Standard Deviation|Mean
814364|NCT01087489|Primary|Discomfort Level and Patient Satisfaction With the Preparation Protocol and Intravitreal Injection|"Discomfort according to the Eye Sensation Scale: 1-none, 2- mild, 3- moderate, 4- severe, 5- extremely severe
Patient satisfaction scale: 1=very unsatisfied, 2=unsatisfied, 3=neutral, 4=satisfied, 5= extremely satisfied"|immediately after injection, 1- hour later, and next day|all 50 patients who completed the study were included in the analysis, each patient received both anesthetic preparations prior to two consecutive (if unilateral disease) intravitreal injections on consecutive visits or in fellow eyes (if bilaterla disease) on the same day||units on a scale||Standard Deviation|Mean
814365|NCT01087502|Secondary|Plasma Concentration of Linagliptin at Trough|Trough levels of concentration of Linagliptin in plasma.|Week 12, 24 and 52|FAS original results (OR). Original results analysis means that data is analyzed exactly as observed, values after rescue medication are not set to missing and no imputation rule is applied for replacing the missing values.||Nmol/L||Geometric Coefficient of Variation|Geometric Mean
814366|NCT01087502|Secondary|Percentage of Patients Who Have a HbA1c Lowering by at Least 0.5%|The percentage of patients with an HbA1c reduction of ≥0.5% at week 12 and week 52 from baseline was calculated for each treatment arm. If a patient did not have an HbA1c value at week 12 or 52 respectively they were considered a failure, so HbA1c reduction less than 0.5%.|Baseline, week 12 and week 52|FAS with non-completers considered as failure imputation (NCF). Results after Week 12 include patients from the excluded study site.||percentage of patients|||Number
814367|NCT01087502|Secondary|Percentage of Patients With HbA1c <6.5%|The percentage of patients with an HbA1c value below 6.5% at week 12 and week 52 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 12 or 52 respectively they were considered a failure, so HbA1c above 6.5%.|Baseline, week 12 and week 52|FAS with baseline HbA1c >=6.5% and non-completers considered as failure imputation (NCF). Results after Week 12 include patients from the excluded study site.||percentage of patients|||Number
814368|NCT01087502|Secondary|Percentage of Patients With HbA1c <7.0%|The percentage of patients with an HbA1c value below 7% at week 12 and week 52 were calculated for each treatment arm. If a patient did not have an HbA1c value at week 12 or 52 respectively, they were considered a failure, so HbA1c above 7%.|Baseline, week 12 and week 52|FAS with baseline HbA1c >=7% and non-completers considered as failure imputation (NCF). Results after Week 12 include patients from the excluded study site.||percentage of patients|||Number
814369|NCT01087502|Secondary|Fasting Plasma Glucose (FPG) Change From Baseline Over Time|This change from baseline reflects the FPG over time minus the baseline FPG. This outcome measure only provides descriptive statistics without any modelling.|Baseline, week 4, week 8, week 12, week 20, week 24, week 28, week 34, week 40, week 46, week 52|FAS. Last observation carried forward (LOCF) was used as the imputation rule. Results do not contain data of patients from the excluded study site.||mg/dL||Standard Deviation|Mean
814419|NCT01087918|Secondary|Pain on a Visual Analogue Scale|Pain was scored on a visual analogue scale from 0 (= no pain) to 100 (= maximal pain). Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Negative values denote improvements.|Baseline, after intervention (4 weeks)|Only 8 patients participated at pain assessments as 1 patient did not suffer from pain.||units on a scale||Standard Deviation|Mean
814371|NCT01087502|Secondary|HbA1c Change From Baseline Over Time|HbA1c is measured as a percentage. Thus, this change from baseline reflects the HbA1c percent over time minus the baseline HbA1c percent. This outcome measure only provides descriptive statistics without any modelling.|Baseline, week 4, week 8, week 12, week 16, week 20, week 24, week 28, week 34, week 40, week 46, week 52|FAS. Last observation carried forward (LOCF) was used as the imputation rule. Results do not contain data of patients from the excluded study site.||Percent||Standard Deviation|Mean
814372|NCT01087502|Primary|HbA1c Change From Baseline to Week 12|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c, renal function impairment and prior use of antidiabetic agents.|Baseline and week 12|"FAS consisting of all randomised patients who were treated with at least one dose of study drug, had a baseline, and at least 1 on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as the imputation rule.
Results for primary endpoint below are the ones reproduced without patients from the excluded study site."||Percent||Standard Error|Mean
814373|NCT01087528|Secondary|Percent of Participants With Scoring Index 3 or 4|"Overall colon cleanliness was judged for capsule endoscopy and colonoscopy on a four-point grading index scale as follows:
poor cleansing level (Large amount of fecal residue.)
fair cleansing level (Enough feces or dark fluid present to preclude a completely reliable examination.)
good cleansing level (Small amount of feces or dark fluid, but not enough to interfere with examination.)
excellent cleansing level (No more than small bits of adherent feces.)"|within 7 days||||||
814374|NCT01087528|Primary|Specificity of Capsule Endoscopy for Indicated Polyps|Readings of videos from the PillCam COLON were performed by trained physicians who identified polyps (types and sizes). Specificity was calculated as the percentage of participants who had negative findings on capsule endoscopy (of a specified category) among participants with negative colonoscopy findings of the same category (reported in Outcome Measure 1). This corresponds to 1 - the false positive rate.|within 7 days||||||
814375|NCT01087528|Primary|Sensitivity of Capsule Endoscopy for Indicated Polyps|Readings of videos from the PillCam COLON were performed by trained physicians who identified polyps (types and sizes). Sensitivity was calculated as the percentage of participants who had positive findings on capsule endoscopy (of a specified category) among those participants who had positive findings on colonoscopy of the same category .The false negative rate is equal to 1 - sensitivity and indicated the percentage of polyps missed by capsule endoscopy.|within 7 days|||percentage of participants||95% Confidence Interval|Number
814376|NCT01087541|Secondary|Systolic and Diastolic Blood Pressure||6 months|||mmHg||Standard Deviation|Mean
814377|NCT01087541|Secondary|Blood Pressure ( Systolic / Diastolic )||Baseline|||mmHg||Standard Deviation|Mean
814378|NCT01087541|Primary|Glycosylated Haemoglobin A1c at 6 Months|Glycohemoglobin A1c at 6 months.|6 months|||Percentage||Standard Deviation|Mean
814379|NCT01087541|Secondary|BMI at 6 Months||6 months|||kg/m2||Standard Deviation|Mean
814380|NCT01087541|Secondary|BMI ( Body Mass Index ) at Start||Baseline|||kg/m2||Standard Deviation|Mean
814381|NCT01087541|Primary|Glycosylated Haemoglobin A1c at Start||Baseline|||Percentage||Standard Deviation|Mean
814382|NCT01087723|Secondary|The Incidence of Stroke|Incidence=the number of participants to experience the event/total number of at risk participants x 100. Stroke was defined as a sudden, focal neurological defect resulting from a cerebrovascular cause, resulting in death or lasting greater than 24 hours that was not due to a readily identifiable cause, such as a tumor, infection, or trauma.|Within 30 days|Participants who were randomized and signed an ICF; ITT population||percentage of participants|||Number
814383|NCT01087723|Secondary|The Incidence of Thrombocytopenia|Incidence=the number of participants to experience the event/total number of at risk participants x 100. Thrombocytopenia was defined as a post-procedural platelet count <100,000 cells/millimeter cubed (cells/mm^3) in a participant with a baseline or pre-procedural platelet count >100,000 cells/mm^3.|Within 30 days|Participants who were randomized and signed an ICF; ITT population||percentage of participants|||Number
814384|NCT01087723|Secondary|The Incidence of Stent Thrombosis (Academic Research Consortium [ARC Definition])|Incidence=the number of participants to experience the event/total number of at risk participants x 100. Stent thrombosis, based on the ARC definition, was defined as angiographic confirmation of stent thrombosis, non-occlusive thrombus, occlusive thrombus, or pathological confirmation of stent thrombosis.|Within 30 days|Participants who were randomized and signed an ICF; ITT population||percentage of participants|||Number
814385|NCT01087723|Secondary|The Incidence of Minor Bleeding: TIMI and GUSTO|Incidence=the number of participants to experience the event/total number of at risk participants x 100. Minor bleeding based on TIMI criteria was defined as any clinically overt sign of bleeding (including observation by imaging techniques) that was associated with a fall in Hb of ≥3 g/dL and ≤5 g/dL (or, when Hb was not available, an absolute drop in Hct of ≥9% and ≤15%). Minor bleeding based on GUSTO criteria was defined as other bleed not requiring blood transfusion or causing hemodynamic compromise.|Within 30 days|Participants who were randomized and signed an ICF; ITT population||percentage of participants|||Number
814386|NCT01087723|Secondary|The Incidence of Major Bleeding: Thrombolysis in MI (TIMI) and Global Utilization of Streptokinase and tPA for Occluded Coronary Arteries (GUSTO)|Incidence=the number of participants to experience the event/total number of at risk participants x 100. Major bleeding based on TIMI criteria was defined as any intra-cranial bleeding, or any bleeding associated with clinically overt signs associated with a drop in Hb of >5 g/dL (or, when Hb was not available, an absolute drop in hematocrit [Hct] >15%). Major bleeding based on GUSTO criteria was defined as severe/life-threatening: intra-cranial hemorrhage or resulting in substantial hemodynamic compromise requiring treatment.|Within 30 days|Participants who were randomized and signed an ICF; ITT population||percentage of participants|||Number
814387|NCT01087723|Secondary|The Incidence of Death at 1 Year|Incidence=the number of participants to experience the event/total number of at risk participants x 100. Death was defined as death from any cause at any time.|Within 1 Year|Participants who were randomized and signed an ICF; ITT population||percentage of participants|||Number
814420|NCT01087918|Secondary|Manual Muscle Test of the Lower Extremity|With the manual muscle test, we examined strength of the lower extremities. Five key muscles on each side are evaluated from 0 (= total paralysis) to 5 (= normal strength). Values for left and right were then averaged. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.|Baseline, after intervention (4 weeks)|||units on a scale||Standard Deviation|Mean
814388|NCT01087723|Secondary|The Incidence of Death, Re-infarction, Non-CABG-related Major Bleeding, or Ischemia-driven Revascularization (IDR)|Incidence=number of participants to experience the event/total number of at risk participants x 100. Death from any cause at any time. Re-infarction was a positive diagnosis of re-infarction not associated with index PCI. Non-CABG major bleeding was any 1 of: intracranial, retroperitoneal, intraocular, access site hemorrhage requiring radiological or surgical intervention, reduction in Hb concentration of >4 g/dL without an overt source of bleeding, reduction in hemoglobin concentration of >3 g/dL with an overt source of bleeding, re-intervention for bleeding, use of any blood product transfusion. IDR was any refractory ischemia-driven repeat percutaneous intervention or bypass graft surgery involving any native coronary or pre-existing bypass graft vessel. In the absence of pain, new ST segment changes indicative of ischemia, acute pulmonary edema, ventricular arrhythmias, or hemodynamic instability presumed to be ischemic in origin, will constitute sufficient evidence of ischemia.|Within 30 days|Participants who were randomized and signed an ICF; ITT population||percentage of participants|||Number
814389|NCT01087723|Secondary|The Composite Incidence of Death, Re-infarction (MI), or Non-CABG Major Bleeding|A participant had a composite event if the participant experienced at least 1 of the 3 components (death, re-infarction [MI], or non-CABG major bleeding) of the composite. Incidence=the number of participants to experience the event/total number of at risk participants x 100. Death was defined as death from any cause at any time. Non-CABG major bleeding was defined as any one of the following: intracranial, retroperitoneal, intraocular, access site hemorrhage requiring radiological or surgical intervention, reduction in Hb concentration of >4 g/dL without an overt source of bleeding, reduction in hemoglobin concentration of >3 g/dL with an overt source of bleeding, re-intervention for bleeding, use of any blood product transfusion. MI was defined as a positive diagnosis of re-infarction (new event) not associated with index PCI.|Within 30 days|Participants who were randomized and signed an ICF; ITT population||percentage of participants|||Number
814390|NCT01087723|Primary|The Composite Incidence of Death and Non-coronary Artery Bypass Graft (CABG) Major Bleeding|A participant was defined to have had a composite event if the participant experienced at least 1 of the 2 components (death or non-CABG major bleeding) of the composite. Incidence=the number of participants to experience the event/total number of at risk participants x 100. Death was defined as death from any cause at any time. Non-CABG major bleeding was defined as any 1 of the following: intra-cranial, retroperitoneal, intraocular, access site hemorrhage requiring radiological or surgical intervention, reduction in hemoglobin (Hb) concentration of >4 grams/deciliter (g/dL) without an overt source of bleeding, reduction in hemoglobin concentration of >3 g/dL with an overt source of bleeding; re-intervention for bleeding, or use of any blood product transfusion.|Within 30 days|Participants who were randomized and signed an ICF; ITT population||percentage of participants|||Number
814391|NCT01087736|Other Pre-specified|PTSD Symptom Severity|The average PTSD symptom severity score during treatment (weeks 4, 8, 12). The PTSD Checklist (PCL) is a self-report measure of the 17 DSM-IV symptoms of PTSD. Respondents rate on a scale from 1 (not at all) to 5 (extremely) how much they were bothered by each symptom in the past month. A total symptom severity score (range = 17 - 85) can be obtained by summing the scores from the 17 items, with higher scores indicating greater severity of PTSD symptoms. Mean scores may be calculated for subscales of intrusion (range 5-25), avoidance (range 7-35), and arousal (range 5-25).|Weeks 4, 8, 12|||units on a scale||Standard Deviation|Mean
814392|NCT01087736|Primary|Percent Drinking Days (%DD)|"Alcohol consumption was assessed at baseline and weekly during the treatment phase (12 weeks) using the Time Line Follow Back (TLFB) interview which yields number of days of alcohol use (DD).
DD: day on which alcohol was consumed Standard alcoholic drink defined as containing 13.6 g of pure alcohol."|Weekly, weeks 1-12, average|||percent days in a week||Standard Deviation|Mean
814393|NCT01087762|Secondary|Change From Baseline in Sacroiliac Spondyloarthritis Research Consortium of Canada (SPARCC) Score at Week 12|The SPARCC scoring method for lesions found on the Magnetic Resonance Imaging (MRI) is based on an abnormal increased signal on the Short-Tau-Inversion Recovery (STIR) sequence, representing bone marrow edema. Total Sacroiliac (SI) joint SPARCC score can range from 0 to 72 with higher scores indicating higher joint inflammation. A negative value in SPARCC change from Baseline indicates an improvement from Baseline. The higher the negative value the higher the reduction of inflammation.|From Baseline to Week 12|The analysis was performed in the Magnetic Resonance Imaging (MRI) Set, a subgroup of subjects participating in an imaging substudy, where MRI measurements at Baseline and Week 12 were performed. Of the 325 patients randomized, 153 participated in the imaging substudy. Of these 153 subjects in the MRI Set, 140 are included in this analysis.||units on a scale||Standard Deviation|Mean
814394|NCT01087762|Secondary|Change From Baseline in the Spine Ankylosing Spondylitis Spine Magnetic Resonance Imaging (MRI) Scoring System for Disease Activity (ASspiMRI-a) in the Berlin Modification at Week 12|The Berlin modification of the ASspiMRI-a is a scoring system with a concentration on Short-Tau-Inversion Recovery (STIR) sequences without other fat saturation techniques. It quantifies changes in 23 Vertebral Units (VU) of the spine. A VU is defined as the region between 2 virtual lines through the middle of each vertebra. Active inflammation is scored by grading the degree of bone marrow edema from 0 to 3 in 1 dimension on 1 or more consecutive slices that represent the highest level of inflammation in a particular VU. Total spine ASspiMRI-a score in the Berlin modification can range from 0 to 69 with higher scores indicating higher disease activity. A negative value in total spine ASspiMRI-a score change from Baseline indicates an improvement from Baseline. The higher the negative value the higher the reduction of inflammation.|From Baseline to Week 12|The analysis was performed in the Magnetic Resonance Imaging (MRI) Set, a subgroup of subjects participating in an imaging substudy, where MRI measurements at Baseline and Week 12 were performed. Of the 325 patients randomized, 153 participated in the imaging substudy. Of these 153 subjects in the MRI Set, 148 are included in this analysis.||units on a scale||Standard Deviation|Mean
814421|NCT01087918|Secondary|Mean Latency of the Averaged Motor Evoked Potentials of the Right and the Left M. Tibialis|Motor evoked potential was elicited by transcranial magnetic stimulation. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Negative values denote improvements.|Baseline, after intervention (4 weeks)|||milliseconds||Standard Deviation|Mean
814422|NCT01087918|Secondary|Spinal Cord Independence Measure III|The SCIM assesses functional independence after spinal cord injury. It is scored from 0 (= total dependence in everyday life) to 100 points (= complete independence in everyday life). Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.|Baseline, after intervention (4 weeks)|||units on a scale||Standard Deviation|Mean
814395|NCT01087762|Secondary|Change From Baseline in the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 24|The BASMI characterizes the spinal mobility of subjects with axial SpA and AS. It is a disease-specific measure consisting of 5 clinical measures to reflect subject axial status: cervical rotation; tragus to wall distance; lateral lumbar flexion; lumbar flexion (modified Schober test); intermalleolar distance. According to the linear definition of the BASMI a score of 0 to 10 is calculated for each item based on the measurement. The mean of the sum of the 5 scores provides the BASMI score. The higher the BASMI score the more severe the patient’s limitation of movement due to their axial SpA. A negative value in BASMI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|From Baseline to Week 24|Intention-to-treat dataset was the Randomized Set (RS). RS with Last Observation Carried Forward (LOCF): for subjects who withdrew for any reason, or subjects with missing Week 24 measurements, or placebo subjects who used escape medication, last observation prior to early withdrawal or Week 24 or before receiving CZP is carried forward to Week 24.||units on a scale||95% Confidence Interval|Least Squares Mean
814396|NCT01087762|Secondary|Change From Baseline in the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 12|The BASMI characterizes the spinal mobility of subjects with axial Spondyloarthritis (SpA) and Ankylosing Spondylitis (AS). It is a disease-specific measure consisting of 5 clinical measures to reflect subject axial status: cervical rotation; tragus to wall distance; lateral lumbar flexion; lumbar flexion (modified Schober test); intermalleolar distance. According to the linear definition of the BASMI a score of 0 to 10 is calculated for each item based on the measurement. The mean of the sum of the 5 scores provides the BASMI score. The higher the BASMI score the more severe the patient’s limitation of movement due to their axial SpA. A negative value in BASMI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|From Baseline to Week 12|Intention-to-treat dataset was the Randomized Set (RS). RS with Last Observation Carried Forward (LOCF): for subjects who withdrew for any reason, or subjects with missing Week 12 measurements, last observation prior to the early withdrawal or Week 12 is carried forward to Week 12.||units on a scale||95% Confidence Interval|Least Squares Mean
814397|NCT01087762|Secondary|Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24|The BASDAI is a validated self-reported instrument which consists of six 10 unit horizontal Numerical Rating Scales (NRSs) to measure severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration, respectively) over the last week. The final BASDAI score ranges from 0 to 10, with lower scores indicating lower disease activity. A negative value in BASDAI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|From Baseline to Week 24|Intention-to-treat dataset was the Randomized Set (RS). RS with Last Observation Carried Forward (LOCF): for subjects who withdrew for any reason, or subjects with missing Week 24 measurements, or placebo subjects who used escape medication, last observation prior to early withdrawal or Week 24 or before receiving CZP is carried forward to Week 24.||units on a scale||95% Confidence Interval|Least Squares Mean
814398|NCT01087762|Secondary|Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 12|The BASDAI is a validated self-reported instrument which consists of six 10 unit horizontal Numerical Rating Scales (NRSs) to measure severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration, respectively) over the last week. The final BASDAI score ranges from 0 to 10, with lower scores indicating lower disease activity. A negative value in BASDAI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|From Baseline to Week 12|Intention-to-treat dataset was the Randomized Set (RS). RS with Last Observation Carried Forward (LOCF): for subjects who withdrew for any reason, or subjects with missing Week 12 measurements, last observation prior to the early withdrawal or Week 12 is carried forward to Week 12.||units on a scale||95% Confidence Interval|Least Squares Mean
814399|NCT01087762|Secondary|Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 24|The BASFI assesses physical function in comprising 10 items relating to activities during the past week. Each item ranges from 0 (“Easy”) to 10 (“Impossible”). The BASFI is the mean of the 10 scores such that the total score ranges from 0 to 10, with lower scores indicating better physical function. A negative value in BASFI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|From Baseline to Week 24|Intention-to-treat dataset was the Randomized Set (RS). RS with Last Observation Carried Forward (LOCF): for subjects who withdrew for any reason, or subjects with missing Week 24 measurements, or placebo subjects who used escape medication, last observation prior to early withdrawal or Week 24 or before receiving CZP is carried forward to Week 24.||units on a scale||95% Confidence Interval|Least Squares Mean
814400|NCT01087762|Secondary|Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 12|The BASFI assesses physical function in comprising 10 items relating to activities during the past week. Each item ranges from 0 (“Easy”) to 10 (“Impossible”). The BASFI is the mean of the 10 scores such that the total score ranges from 0 to 10, with lower scores indicating better physical function. A negative value in BASFI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|From Baseline to Week 12|Intention-to-treat dataset was the Randomized Set (RS). RS with Last Observation Carried Forward (LOCF): for subjects who withdrew for any reason, or subjects with missing Week 12 measurements, last observation prior to the early withdrawal or Week 12 is carried forward to Week 12.||units on a scale||95% Confidence Interval|Least Squares Mean
814423|NCT01087918|Secondary|Berg Balance Scale|The Berg Balance Scale is a performance-based measure of balance. It is scored from 0 (= failed all items) to 56 points (= scored maximally in all items). Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.|Baseline, after intervention (4 weeks)|||units on a scale||Standard Deviation|Mean
814424|NCT01087918|Secondary|Walking Index for Spinal Cord Injury II|The WISCI II describes whether a patients requires waling aids, braces or personal assistance to walk 10 meters. It is an ordinal scale varying from 0 (= not able to walk 10 meters) to 20 (= able to walk 10 meters with no walking aids, braces or personal assistance). Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.|Baseline, after intervention (4 weeks)|||units on a scale||Standard Deviation|Mean
814401|NCT01087762|Secondary|Assessment in Axial Spondyloarthritis International Society 20 % (ASAS20) Response Criteria at Week 24|"The ASAS20 is defined as an improvement of at least 20 % and absolute improvement of at least 1 unit on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 following domains:
Patient's Global Assessment of Disease Activity
Pain assessment (total spinal pain)
Function (represented by Bath Ankylosing Spondylitis Functional Index (BASFI))
Inflammation (the mean of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration)
and absence of deterioration in the potential remaining domain (deterioration is defined as a relative worsening of at least 20 % and an absolute worsening of at least 1 unit)."|Week 24|Intention-to-treat dataset was the Randomized Set (RS). RS with non-responder imputation: subjects who withdrew for any reason or placebo subjects who used escape medication are considered as non-responders from drop out timepoint or when escape therapy was initiated. Subjects with missing data at a visit are non-responders for that visit, too.||percentage of participants||95% Confidence Interval|Number
814402|NCT01087762|Primary|Assessment in Axial Spondyloarthritis International Society 20 % (ASAS20) Response Criteria at Week 12|"The ASAS20 is defined as an improvement of at least 20 % and absolute improvement of at least 1 unit on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 following domains:
Patient's Global Assessment of Disease Activity
Pain assessment (total spinal pain)
Function (represented by Bath Ankylosing Spondylitis Functional Index (BASFI))
Inflammation (the mean of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration)
and absence of deterioration in the potential remaining domain (deterioration is defined as a relative worsening of at least 20 % and an absolute worsening of at least 1 unit)."|Week 12|Intention-to-treat dataset was the Randomized Set (RS). RS with non-responder imputation: subjects who withdrew for any reason or placebo subjects who used escape medication are considered as non-responders from drop out timepoint or when escape therapy was initiated. Subjects with missing data at a visit are non-responders for that visit, too.||percentage of participants||95% Confidence Interval|Number
814403|NCT01087788|Secondary|Change From Baseline in Modified Total Sharp Score (mTSS) at Week 48|"Van der Heijde modified Total Sharp Score (mTSS) is a methodology to assess the degree of joint damage by quantifying the extent of bone erosions and joint space narrowing for 64 and 52 joints, respectively, with higher scores representing greater damage. mTSS (bone erosions) ranges from 0 (best possible outcome) to 320 (worst possible outcome); mTSS (joint space narrowing) ranges from 0 (best possible outcome) to 208 (worst possible outcome); and total score ranges from 0 (best possible outcome) to 528 (worst possible outcome).
For the analysis of this outcome measure, the change from Baseline to Week 48 was imputed using the median change from Baseline among all subjects for those subjects, which had less than 2 radiographs. The post-hoc analysis presented here is based on the subgroup of subjects which had a Baseline mTSS value greater than 6."|From Baseline to Week 48|Randomized Set (RS) with imputation: for subjects who withdrew for any reason, or subjects with missing Week 48 measurements, and for all placebo subjects after the switch to CZP, Week 48 scores are linearly extrapolated from the last two available radiographs prior to early withdrawal or Week 24 or before receiving CZP.||units on a scale||95% Confidence Interval|Least Squares Mean
814404|NCT01087788|Secondary|Psoriasis Area Severity Index (PASI75) Response at Week 24 in the Subgroup of Subjects With Psoriasis (PSO) Involving at Least 3 % Body Surface Area (BSA) at Baseline|The PASI75 response assessments are based on at least 75 % improvement in the PASI score from Baseline. The PASI score is a measure of the average redness, thickness, and scaliness of the psoriatic skin lesions (each graded on a 0 to 4 scale), weighted by the area of involvement.|Week 24|Intention-to-treat dataset was the Randomized Set (RS). RS with non-responder imputation: subjects who withdrew for any reason or placebo subjects who used escape medication are considered as nonresponders from drop out timepoint or when escape therapy was initiated. Subjects with missing data at a visit are non-responders for that visit, too.||percentage of participants||95% Confidence Interval|Number
814405|NCT01087788|Secondary|Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 24|The HAQ-DI is a measure of function in Arthritis. There are 20 items in eight categories that represent a comprehensive set of functional activities on a scale from 0 (without difficulty) to 3 (unable to perform without assistance). The category scores are averaged into an overall HAQ-DI from 0 to 3. Scores of 0 to 1 generally represent mild to moderate difficulty, 1 to 2 represent moderate to severe disability, and 2 to 3 indicate severe to very severe disability. A negative value in HAQ-DI change from Baseline indicates an improvement from Baseline. The higher the negative value, the higher the improvement.|From Baseline to Week 24|Intention-to-treat dataset was the Randomized Set (RS). RS with Last Observation Carried Forward (LOCF): for subjects who withdrew for any reason, or subjects with missing Week 24 measurements, or placebo subjects who used escape medication, last observation prior to early withdrawal or Week 24 or before receiving CZP is carried forward to Week 24.||units on a scale||95% Confidence Interval|Least Squares Mean
814406|NCT01087788|Secondary|American College of Rheumatology 20 (ACR20) Response at Week 24|ACR20 responders are those subjects with at least 20 % improvement from Baseline for Tender Joint Count (TJC), Swollen Joint Count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS).|Week 24|Intention-to-treat dataset was the Randomized Set (RS). RS with non-responder imputation: subjects who withdrew for any reason or placebo subjects who used escape medication are considered as nonresponders from drop out timepoint or when escape therapy was initiated. Subjects with missing data at a visit are non-responders for that visit, too.||percentage of participants||95% Confidence Interval|Number
814425|NCT01087918|Primary|10 Meter Walking at Preferred Speed|The 10 meter walk test assesses the time required to walk 10 meters at the patient's preferred speed (in seconds). Results were converted to walking speed [m/s]. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.|Baseline, after intervention (4 weeks)|||meters per second||Standard Deviation|Mean
814426|NCT01087944|Secondary|Number of Participants With Adverse Events (AE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Upto Day 36|The ITT population included all participants who received at least one injection||participants|||Number
814407|NCT01087788|Primary|Change From Baseline in Modified Total Sharp Score (mTSS) in Modification for Psoriatic Arthritis at Week 24|Van der Heijde modified Total Sharp Score (mTSS) is a methodology to assess the degree of joint damage by quantifying the extent of bone erosions and joint space narrowing for 64 and 52 joints, respectively, with higher scores representing greater damage. mTSS (bone erosions) ranges from 0 (best possible outcome) to 320 (worst possible outcome); mTSS (joint space narrowing) ranges from 0 (best possible outcome) to 208 (worst possible outcome); and total score ranges from 0 (best possible outcome) to 528 (worst possible outcome). For the pre-defined analysis of this outcome measure, 0 was used for Baseline and the maximum observed mTSS value was used for Week 24 for those subjects which had less than 2 radiographs. The re-analysis is restricted to those subjects in the Randomized Set who have at least 2 x-ray values at scheduled visits, which are at least 8 weeks apart.|From Baseline to Week 24|Intention-to-treat dataset was the Randomized Set (RS). RS with imputation: for subjects who withdrew for any reason, or subjects with missing Week 24 measurements, or placebo subjects who used escape medication, scores are linearly extrapolated from the last two radiographs prior to early withdrawal or Week 24 or before receiving CZP.||units on a scale||95% Confidence Interval|Least Squares Mean
814408|NCT01087788|Primary|American College of Rheumatology 20 (ACR20) Response at Week 12|ACR20 responders are those subjects with at least 20 % improvement from Baseline (BL) for Tender Joint Count (TJC), Swollen Joint Count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS).|Week 12|Intention-to-treat dataset was the Randomized Set (RS). RS with non-responder imputation: subjects who withdrew for any reason or placebo subjects who used escape medication are considered as nonresponders from drop out timepoint or when escape therapy was initiated. Subjects with missing data at a visit are non-responders for that visit, too.||percentage of participants||95% Confidence Interval|Number
814409|NCT01087801|Primary|Volume of Fluid ≥ 3.5mL (Boolean Expression Evaluated as Yes or no).|Volume of pancreatic fluid. The volume is the number of mL of pancreatic fluid.|First 5 minutes after treatment administration|||Participants|||Number
814410|NCT01087801|Primary|Endoscopic Sample|"Is Volume ≥ 3.5 mL Is HCO3 concentration ≥ 40 mEq/L Is DNA mutational analysis (K-ras-2 gene Fluorescence peak height ≥ 50 Relative Florescence Units panel assessable markers informative ≥ 8).
(Note- The outcome value is boolean (yes or no) as an answer)."|First 5 minutes after treatment administration||||||
814411|NCT01087814|Primary|Serum Levels of Efavirenz|Serum levels of efavirenz were measured on the fifth day of taking efavirenz (tablet) and the fifth day of taking an overencapsulated efavirenz.|5th day of taking drug|||ng/mL||Standard Deviation|Mean
814412|NCT01087905|Secondary|Incremental Cost-Effectiveness Ratio for 7-Day Point Prevalence Abstinence From Smoking at 26 Weeks Post-Quit by Nicotine Replacement Therapy (NRT) Group|For cost analyses, we computed the costs of intervention per caller, the cost per quit based on the 6-month ITT 7-day PPA, and the incremental cost-effectiveness ratio (ICER. Intervention costs included direct costs associated with registration, provision of NRT and counseling (standard and MAC), and mailing of a quit guide (all participants) and a MAC information sheet (MAC participants only). Facility space, supplies, and physician supervision time were included in the call costs; research-related costs were excluded. ICER ratio is a measure of the added cost per added quit for two treatments. ICER was computed as the cost difference between the least intensive treatment group (2 weeks of nicotine patch only) and a more intensive comparison group divided by the difference in the quit rates of the two groups being compared; e.g., the ICER for the group that received 2 weeks of nicotine patch and nicotine gum = (213-178)/(.482-.384) = $357.|26 weeks after the target quit smoking date|"No a priori power analysis was conducted for this secondary outcome."||U.S. Dollars|||Number
814413|NCT01087905|Primary|7-Day Point Prevalence Abstinence From Smoking by Nicotine Replacement Therapy (NRT) Group|Self-reported total abstinence from any tobacco use (even a single puff) for the seven days preceding the target follow-up day.|26 weeks after the target quit smoking date|The study was originally powered to detect at least a 6.4% increase in the abstinence rate due to an enhanced intervention (e.g., 6 wks NRT); this effect size was based on prior quitline studies; we predicted that abstinence rates at 6 months would be approximately 12% in a standard intervention vs. 18.4% in an enhanced intervention.||Percentage of participants not smoking|||Number
814414|NCT01087905|Primary|7-Day Point Prevalence Abstinence From Smoking by Intervention|Self-reported total abstinence from any tobacco use (even a single puff) for the seven days preceding the target follow-up day.|26 weeks after the target quit smoking date|The study was originally powered to detect at least a 6.4% increase in the abstinence rate due to an enhanced intervention (e.g., 6 wks NRT); this effect size was based on prior quitline studies; we predicted that abstinence rates at 6 months would be approximately 12% in a standard intervention vs. 18.4% in an enhanced intervention.||Percentage of participants not smoking|||Number
814415|NCT01087918|Secondary|Figure of Eight Test|The Figure of Eight Test is a 10m Walk Test in the shape of a figure of eight. Time for completion of one lap is recorded and converted to [m/s]. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.|Baseline, after intervention (4 weeks)|||meters per second||Standard Deviation|Mean
814416|NCT01087918|Primary|10 Meter Walking at Maximal Speed|The 10 meter walking speed assesses the time needed to walk 10 meters at maximal speed (in seconds). Results were converted to walking speed [m/s]. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.|Baseline, after intervention (4 weeks)|||meters per second||Standard Deviation|Mean
814417|NCT01087918|Secondary|Falls Efficacy Scale|The Falls Efficacy Scale evaluates fear of falling in everyday life situations. It is scored from 16 (= no fear at all) to 64 points (= maximal fear in all items). Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Negative values denote improvements.|Baseline, after intervention (4 weeks)|||units on a scale||Standard Deviation|Mean
814418|NCT01087918|Secondary|Response Time of the Lower Extremities|We measured choice stepping response time on a plate in a standing position. Participant had to move their feet to flashing LEDs as fast as possible. Valid values of the right and the left foot were averaged. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Negative values denote improvements.|Baseline, after intervention (4 weeks)|||milliseconds||Standard Deviation|Mean
814427|NCT01087944|Secondary|Number of Participants With Abnormalities in Electrocardiograms|A 12-lead ECG was recorded after the participant had been in a semi-supine position for at least 10 minutes. Any clinically significant abnormalities noted on an ECG after the first dose of study drug were captured as AEs|Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)|The ITT population included all participants who received at least one injection||participants|||Number
814428|NCT01087944|Secondary|Number of Participants With Abnormalities in Pulse Rate, Temperature, and Blood Pressure|The pulse rate, temperature and blood pressure was assessed during a physical examination. Pulse rate was assessed in beats per minute (bpm), temperature was assessed in degree Celsius (°С), and blood pressure was assessed in millimeters of mercury (mmHg). Vital signs were taken while the participant was supine.|Week 1, Day 1 (Baseline), Week 2 (Day 8 ± 2 days), Week 3 (Day 15 ± 2 days), Week 4 (Day 22 ± 2 days), Week 5 (Day 29 ± 2 days), Week 6 (Day 36 ± 2 days)|The ITT population included all participants who received at least one injection||participants|||Number
814429|NCT01087944|Secondary|Number of Participants With Marked Laboratory Abnormalities in Creatinine|A marked abnormality was defined as a test result which was outside of the marked abnormality range, and which represented a clinically relevant change from baseline of at least the designated amount. The marked reference range for Creatinine was 0- 154 (micromoles/liter [umol/L]). The clinical relevant change (decrease/ increase) for Creatinine was (n.d, 50%).|Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)|The ITT population included all participants who received at least one injection||participants|||Number
814430|NCT01087944|Secondary|Number of Participants With Marked Laboratory Abnormalities in Blood Urea Nitrogen (BUN), Chloride, Potassium, Sodium, Calcium, Glucose|A marked abnormality was defined as a test result which was outside of the marked abnormality range, and which represented a clinically relevant change from baseline of at least the designated amount. The marked reference range for BUN was 0.0-14.3 (millimoles per Liter [mmol/L]), Chloride was 95-115 (mmol/L), Potassium was 2.9-5.8 (mmol/L), Sodium was 130-150 (mmol/L), Calcium was 2.00-2.90 (mmol/L), and Glucose was 2.80-11.10 (mmol/L). The clinical relevant change (decrease/ increase) for BUN was (n.d, 50%), Chloride was (7%, 7%), Potassium was (20%, 20%), Sodium was (7%, 7%), Calcium was (10%, 10%), and Glucose was (75%, 75%) respectively.|Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)|The ITT population included all participants who received at least one injection||participants|||Number
814431|NCT01087944|Secondary|Number of Participants With Marked Laboratory Abnormalities in Serum Glutamic Oxaloacetic Transaminase (SGOT), Serum Glutamic-Pyruvic Transaminase (SGPT), and Alkaline Phosphatase|A marked abnormality was defined as a test result which was outside of the marked abnormality range, and which represented a clinically relevant change from baseline of at least the designated amount. The marked reference range for SGOT was 0-80 (Units Per Litre [U/L]), SGPT was 0-110 U/L, and alkaline phosphatase was 0-220 U/L. The clinical relevant change (decrease/ increase) for SGOT was (n.d, 50%), SGPT was (n.d, 50%), and ALP was (n.d, 50%) respectively.|Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)|The ITT population included all participants who received at least one injection||participants|||Number
814432|NCT01087944|Secondary|Number of Participants With Marked Laboratory Abnormalities in Prothrombin Time (PT) International Normalized Ratio (INR)|A marked abnormality was defined as a test result which was outside of the marked abnormality range, and which represented a clinically relevant change from baseline of at least the designated amount. The marked reference range for PT-INR was n.d.-2.00. The clinical relevant change (decrease/ increase) for PT-INR was (n.d, 30%).|Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)|The ITT population included all participants who received at least one injection||participants|||Number
814433|NCT01087944|Secondary|Number of Participants With Marked Laboratory Abnormalities in Right Blood Cell (RBC)|A marked abnormality was defined as a test result which was outside of the marked abnormality range, and which represented a clinically relevant change from baseline of at least the designated amount. The marked reference range for RBC was 3.80-6.10 (10*12/L). The clinical relevant change (decrease/ increase) for RBC was (15%, 15%).|Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)|The ITT population included all participants who received at least one injection||participants|||Number
814434|NCT01087944|Secondary|Number of Participants With Marked Laboratory Abnormalities in Platelet, White Blood Cell (WBC), Basophil, Eosinophil, Lymphocyte, Monocyte and Neutrophil|A marked abnormality was defined as a test result which was outside of the marked abnormality range, and which represented a clinically relevant change from baseline of at least the designated amount. The marked reference range for Platelets was 100-550 (10*9/L), for WBC was 3.0-18.0 (10*9/L), for Basophils was 0.00-0.40 (10*9/L), for Eosinophil was 0.00-0.90 (10*9/L), for Lymphocytes was 0.70-7.60 (10*9/L), Monocyte was 0.00-1.70 (10*9/L), and Neutrophil 1.50-9.25 (10*9/L). The clinical relevant change (decrease/increase) for platelet was (30%, 50%), WBC was (30%, 30%), Basophil was (n.d, 100%), Eosinophil was (n.d, 100%), Lymphocyte was (30%, 30%), Monocyte was (n.d, 100%) and Neutrophil was (20%, 20%) respectively.|Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)|The ITT population included all participants who received at least one injection||participants|||Number
814435|NCT01087944|Secondary|Number of Participants With Marked Laboratory Abnormalities in Hematocrit|A marked abnormality was defined as a test result which was outside of the marked abnormality range, and which represented a clinically relevant change from baseline of at least the designated amount. The marked reference range for hematocrit was 0.31-0.56 fraction. The clinical relevant change (decrease/ increase) for hematocrit was (15%, 15%).|Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)|The ITT population included all participants who received at least one injection||participants|||Number
814436|NCT01087944|Secondary|Number of Participants With Marked Laboratory Abnormalities in Hemoglobin, Albumin and Total Protein|A marked abnormality was defined as a test result which was outside of the marked abnormality range, and which represented a clinically relevant change from baseline of at least the designated amount. The marked reference range for hemoglobin was 110-200 (gram per liter [g/L]), albumin was 30.0-n.d g/L, and total protein was 55-87 g/L. The clinical relevant change (decrease/ increase) for hemoglobin was (15%, 15%), albumin was (20%, n.d) and total protein was (20%, 20%) respectively.|Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)|The ITT population included all participants who received at least one injection||participants|||Number
814466|NCT01088399|Other Pre-specified|Number of Participants Who Died While in the Study||Study enrollment up to approximately 10 years|All participants with baseline and at least 1 post-baseline visit.||participants|||Number
814437|NCT01087944|Primary|Feasibility of Peginterferon Alfa-2a Administration by Autoinjector|The feasibility of PEG-INF administration by AI was assessed by Injection Method Observational Survey questions, based on following pre-defined questions using a “Yes” or “No” response: 1) Did the participant exhibit any nervousness prior to the injection? 2) Did the participant exhibit any difficulty initiating the injection? 3) Did the participant appear confident performing the injection? 4) Did the participant follow the instructions for performing the injection without the need for additional instructions or guidance? 5) Did the participant experience any technical problems with the device or syringe during the injection? 6) Did the participant withdraw the device/syringe before the injection was complete? 7) Did the participant exhibit any visible pain or physical discomfort? 8) Did the participant appear to be satisfied using the device or syringe? 9) Did the participant exhibit any frustration using the syringe or device?|Week 1, Day 1 (Baseline), Week 2 (Day 8 ± 2 days), Week 3 (Day 15 ± 2 days), Week 4 (Day 22 ± 2 days), Week 5 (Day 29 ± 2 days), Week 6 (Day 36 ± 2 days)|The intent-to-treat (ITT) population included all participants who received at least one injection||participants|||Number
814438|NCT01087957|Secondary|Berg Balance Scale|The Berg Balance Assessment is a 14 item scale designed to measure balance in adults in a clinical setting. Each item is scored on a scale of 0-4 with a score of 0 indicating the most difficulty with the balance task. A score from 0 to 20 represents balance impairment, 21 to 40 represents acceptable balance, and 41-56 represents good balance.|6 months|||units on a scale||Standard Error|Mean
814439|NCT01087957|Secondary|Modified Emory Functional Ambulation Profile Stair Time|The Modified Emory Functional Ambulation Profile (mEFAP) Stair time sub-task is composed of ascending and descending 4 Stairs with the score consisting of the number of seconds required to complete the task. The Stair time sub-task score is added to the other 4 subtask scores to calculate the total mEFAP score .|6 months|||seconds||Standard Error|Mean
814440|NCT01087957|Secondary|Modified Emory Functional Ambulation Profile Obstacle Course|The Modified Emory Functional Ambulation Profile (mEFAP) Obstacle course sub-task is composed navigating a Standardized Obstacle Course with the score consisting of the number of seconds required to complete the task. The obstacle course sub-task is added to the other 4 sub-tasks to calculate the total mEFAP score.|6 months|||seconds||Standard Error|Mean
814441|NCT01087957|Secondary|Modified Emory Functional Ambulation Profile Timed up and Go|The Modified Emory Functional Ambulation Profile (mEFAP) Timed up and Go subtask is composed of rising from a chair, walking 3-meters, and returning to a seated position with the score consisting of the number of seconds required to complete the task. The Timed up and Go subtask is added to the other 4 sub-task scores to calculate the total mEFAP score.|6 months|||seconds||Standard Error|Mean
814442|NCT01087957|Secondary|Modified Emory Functional Ambulation Profile Carpet Time|The Modified Emory Functional Ambulation Profile (mEFAP) Carpet time sub-task is composed of a 5 meter walk on a carpeted surface with the score consisting of the number of seconds required to complete the task. The score on the Carpet time sub-task is added to the other 4 sub-tasks to calculate the total mEFAP score .|6 months|||seconds||Standard Error|Mean
814443|NCT01087957|Secondary|Modified Emory Functional Ambulation Profile Floor Time|The Modified Emory Functional Ambulation Profile (mEFAP) Floor time sub-task is composed a timed 5 meter walk on a hard Floor. The score consists of the number of seconds required to complete the task. The Floor Time sub-task is added to the other 4 sub-tasks to make up the total mEFAP score.|6 months|||seconds||Standard Error|Mean
814444|NCT01087957|Secondary|Modified Emory Functional Ambulation Profile Total Score|The Modified Emory Functional Ambulation Profile (mEFAP) is composed of 5 subtasks: (1) 5 meter walk on a hard Floor, (2) 5 meter walk on a carpeted surface, (3) Timed Up & Go (rising from a chair, a 3-meter walk, and return to a seated position), (4) Navigating a Standardized Obstacle Course, and (5) ascending and descending 4 Stairs. Each is a timed task with the score consisting of the number of seconds required to complete the task. Upon completion of the entire data collection session, a total mEFAP score is calculated by adding the score on each subtask.|6 months|||seconds||Standard Error|Mean
814445|NCT01087957|Secondary|Six Minute Walk Test||6 months|||meters||Standard Error|Mean
814446|NCT01087957|Primary|Device Related Serious Adverse Events|The device related serious adverse event (SAE) measure is a count of the incidences of adverse events defined as serious (Incapacitating with inability to do work or usual activities; signs and symptoms may be systemic in nature or require medical evaluation and/or treatment; requiring additional hospitalization or intensive care (prolonged hospitalization) and device related (any AE for which a causal relationship between the event and the presence of the device, or the performance of the device system, is at least a reasonable possibility (i.e., the relationship cannot be excluded).|6 months|Intention to treat||number of device related SAEs|||Number
814447|NCT01087957|Primary|Stroke Impact Scale (SIS) Composite Score|The SIS Composite score is equal to sum of scores for Mobility, ADL/IADL, and Social Participation domains. The questions for each domain are scored on a scale of 1-5, the higher the score the less the impact of Stroke on that domain question. The Mobility domain has 9 questions with scores ranging from 9 to 45. The ADL/IADL domain has 10 questions with scores ranging from 10-150- and the Social Participation domain has 8 question with a score of 8-40.|6 months|Intention to treat||points||Standard Error|Mean
814448|NCT01087957|Primary|Gait Velocity|Improved ambulation status, specific to increase in gait velocity (m/s)|6 months|Intention to treat||m/sec||Standard Error|Mean
814449|NCT01087970|Other Pre-specified|Number of Participants Who Died While on Treatment and Died During 30-Day Post-Treatment Discontinuation Follow-Up (FU)|Presented are the number of participants who died due to adverse events (AEs) while on treatment and participants who died due to progressive disease (PD) during the 30-day post-treatment discontinuation FU.|From enrollment to 30 days post-treatment discontinuation up to 26.4 months|All enrolled participants who received at least 1 dose of any study drug.||participants|||Number
814489|NCT01088464|Primary|PK: Cmax of Necitumumab After Multiple Doses|Cmax at steady state (after the last dose of the initial 6-week treatment cycle).|Cycle 1, Day 29; For Cohorts 1, 2 and 3: predose (prior to fourth infusion for Cohorts 1 and 3; prior to third infusion for Cohort 2), immediately after end of infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 h after end of infusion|All participants who received multiple doses of study drug and had Cmax values for Day 29 of Cycle 1.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
814925|NCT01086215|Secondary|Concomitant Treatments Used With the AngioJet® System|The # of patients exposed to each treatment option at least once in the given thrombotic condition during the Index Procedure|Day 1|||participants|||Number
814450|NCT01087970|Secondary|Change From Baseline in Performance Status Scale for Head and Neck Cancer (PSS-HNC)|PSS-HNC is a clinician-rated instrument designed to measure speaking and eating disabilities of participants with head and neck cancer and consists of 3 subscales: normalcy of diet (NOD) subscale measures the ability of the participants to eat a normal diet, subscale ranges from 0 (non-oral feeding) to 100 (unrestricted diet); understandability of speech (UOS) subscale measures the degree a clinician is able to understand the participant’s speech, subscale ranges from 0 (never understandable) to 100 (always understandable); eating in public (EIP) subscale, rating based on the participant’s response to the questions of whom he/she eats with and in what setting, subscale ranges from 0 (always eats alone) to 100 (no restriction of place, food, or companion). Change from baseline: negative value represents a decrease in function and a positive value represents an increase in function.|Baseline, Day 1 of Cycles 2, 4, 6, cetuximab monotherapy Cycles 2 and 4 (21-day cycle)|All treated participants who had PSS-HNC assessments at baseline and in Cycles 2, 4, 6, cetuximab monotherapy Cycles 2 and 4. Exclude those from a noncompliant study site.||units on a scale||Standard Deviation|Mean
814451|NCT01087970|Secondary|Change From Baseline in Participant-Reported European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L)|EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D dimension. A regression equation defines a utility value for these health states to generate an index score. The possible values for index score range from -0.594 (severe problems in all 5 dimensions) to 1 (no problem in all dimensions) on a scale where 1 represents the best possible health state. The EQ-5D Visual Analog Scale (VAS) is used to record a participant’s rating for his/her current health-related quality of life state on the day of questionnaire administration and is captured on a scale of 0 (worst imaginable health state) to 100 (best imaginable health state).|Baseline, Day 1 of Cycles 2, 4, 6, cetuximab monotherapy Cycles 2 and 4 (21-day cycle)|All treated participants who completed the EQ-5D-3L and VAS at baseline and in Cycles 2, 4, 6, cetuximab monotherapy Cycles 2 and 4. Exclude those from a noncompliant study site.||units on a scale||Standard Deviation|Mean
814452|NCT01087970|Secondary|Percentage of Participants Having a Confirmed Partial Response (PR) or Complete Response (CR)|PR or CR is classified by the investigators according to RECIST criteria version 1.0. PR is a ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesions; CR is the disappearance of all target and non-target lesions. Percentage of participants having a PR or CR is calculated as a total number of participants with PR or CR from enrollment until disease progression or recurrence divided by the total number of participants treated, then multiplied by 100.|From enrollment to objectively determined progressive disease up to 15.3 months (tumor assessments performed every other cycle during study treatment until progressive disease)|All treated participants excluding those from a noncompliant study site.||percentage of participants||95% Confidence Interval|Number
814453|NCT01087970|Secondary|Overall Survival (OS)|OS is defined as the duration from the date of enrollment to the date of death from any cause. For participants who were alive at the time of the data inclusion cutoff, OS was censored at the date of last contact prior to that cut-off date.|From enrollment to the date of death from any cause up to 26.4 months (assessment completed during trial period at least every 3 months)|All treated participants excluding those from a noncompliant study site. The number of participants censored was 22.||months||95% Confidence Interval|Median
814454|NCT01087970|Primary|Progression-Free Survival (PFS)|PFS was defined as the duration from the date of enrollment to the first date of documented objective progressive disease (PD) or death from any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. PD is ≥20% increase in sum of longest diameter of target lesions or the appearance of new lesions. For participants who were not known to have died or to have had objective PD at the time of the data inclusion cutoff, PFS was censored at their last objective progression-free disease assessment prior to the cutoff date or the date of initiation of subsequent systemic anticancer therapy.|From enrollment to measured progressive disease up to 15.3 months (tumor assessments performed every other cycle during study treatment, and then every 6 weeks during follow-up)|All treated participants excluding those from a noncompliant study site. The number of participants censored was 9.||months||95% Confidence Interval|Median
814455|NCT01087996|Secondary|Change in New York Heart Association Class at 12-months||12 months|||participants|||Number
814456|NCT01087996|Secondary|Change in Minnesota Living With Heart Failure Total Score|The Minnesota living with heart failure questionnaire uses a 6-point, zero to five, Likert scale. The total score is the sum of the 21 responses. The total score is considered the best measure of how heart failure and treatments impact a patients quality of life. The max score is 105, minimum score is 0. A lower score is considered a better quality of life.|12 months|||units on a scale||95% Confidence Interval|Mean
814457|NCT01087996|Secondary|Change in Distance Walked in 6-minutes From Baseline.||12-months|||meters||95% Confidence Interval|Mean
814458|NCT01087996|Secondary|CT Measure of Scar Size as % of LV Mass||Baseline Month 13 post-catheterization|||percent||95% Confidence Interval|Mean
814459|NCT01087996|Secondary|CT Measure of End Systolic Volume||Baseline Month 13 post-catheterization|||ml||95% Confidence Interval|Mean
814460|NCT01087996|Secondary|CT Measure of End Diastolic Volume||Baseline Month 13 post-catheterization|||ml||95% Confidence Interval|Mean
814461|NCT01087996|Secondary|CT Measure of Left Ventricular Ejection Fraction||Baseline Month 13 post-catheterization|||percent||95% Confidence Interval|Mean
814462|NCT01087996|Secondary|CT Infarct Size From Early Enhanced Defect: - Difference Between the Baseline and 13-month|Percentage change from 13-months post-catheterization to baseline.|Baseline Month 13 post-catheterization|||percent change from baseline||95% Confidence Interval|Mean
814463|NCT01087996|Primary|Incidence of TE-SAE Define as Composite of Death, Non-fatal MI, Stroke, Hospitalization for Worsening Heart Failure, Cardiac Perforation, Pericardial Tamponade, Ventricular Arrhythmias >15 Sec. or With Hemodynamic Compromise or Atrial Fibrillation||One month post-catheterization|||percentage of participants||95% Confidence Interval|Number
814464|NCT01088295|Secondary|Safety and Tolerability of Telmisartan||24 weeks||||||
814465|NCT01088295|Primary|Median Change in Visceral Adipose Tissue (VAT) Volume|VAT volume was quantified at each timepoint by L4-L5 single slice computed tomography|Baseline and 24 weeks|as-treated analysis||cm^2||Inter-Quartile Range|Median
814467|NCT01088399|Secondary|Change From Baseline in the Total Z Score of the Disease-specific Module of the Questions of Life Satisfaction (QLS-H).|QLS-H is a self-administered, weighted, quality of life (QoL) questionnaire consisting of 9 items developed for participants with growth hormone deficiency. Scores were corrected for age, gender, and country differences, and expressed as Z-scores based on country-specific reference ranges. Participants indicate how important a certain dimension of QoL is to them and are then questioned as to their degree of satisfaction with that dimension. Each item is rated on a 5-point Likert scale ranging from not important (1) to extremely important (5) and from dissatisfied (1) to very satisfied (5). The weighted score for the degree of satisfaction (weighted satisfaction) with a particular dimension=(importance - 1)x(2 x satisfaction - 5). Total Z-score is obtained by adding the individual item scores of the 9 dimensions, and range from -108 (representing very low satisfaction) to +180 (representing very high satisfaction).|Baseline, interim time point (5 years), and study completion (10 years)|All participants with baseline and at least 1 post-baseline visit whose study therapy was known (treated or untreated) and has a Total Z Score.||Z-score||Standard Deviation|Mean
814468|NCT01088399|Secondary|Percentage of Participants Experiencing a Bone Fracture (Fracture Incidence)||Baseline through 10 years|All participants with baseline and at least 1 post-baseline visit and who provided bone fracture information.||percentage of participants|||Number
814469|NCT01088399|Secondary|Cardiovascular Risk Factor-Change From Baseline in Waist Circumference|Change in waist circumference was used as an indicator of cardiovascular risk.|Baseline, interim time point (5 years), and study completion (10 years)|All participants with baseline and at least 1 post-baseline visit whose study therapy was known (treated or untreated) and had waste circumference data.||centimeters (cm)||Standard Deviation|Mean
814470|NCT01088399|Secondary|Cardiovascular Risk Factor-Change From Baseline in Cholesterol and Triglycerides|Change from baseline in total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C) and triglycerides were used as an indicator of cardiovascular risk and are presented.|Baseline, interim time point (5 years), and study completion (10 years)|All participants with baseline and at least 1 post-baseline visit whose study therapy was known (treated or untreated) and had cholesterol or triglyceride data.||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
814471|NCT01088399|Secondary|Cardiovascular Risk Factor-Change From Baseline in Systolic (SBP) and Diastolic Blood Pressure (DBP)|Change in SBP and DBP were used as an indicator of cardiovascular risk.|Baseline, interim time point (5 years), and study completion (10 years)|All participants with baseline and at least 1 post-baseline visit whose study therapy was known (treated or untreated) and BP data.||millimeters of mercury (mmHg)||Standard Deviation|Mean
814472|NCT01088399|Secondary|Cardiovascular Risk Factor-Change From Baseline in Body Mass Index (BMI)|Change in BMI was used as an indicator of cardiovascular risk. Body mass index (BMI) is an estimate of body fat based on body weight divided by height squared.|Baseline, interim time point (5 years), and study completion (10 years)|All participants with baseline and at least 1 post-baseline visit whose study therapy was known (treated or untreated) and had BMI data.||kilogram per square meter (kg/m^2)||Standard Deviation|Mean
814473|NCT01088399|Primary|Clinically Significant Adverse Events|A summary of all reported serious adverse events (SAE) and other adverse events regardless of causality are provided in the Adverse Events module of this record.|Baseline to study completion (approximately 10 years)|All participants with baseline and at least 1 post-baseline visit whose study therapy was known (treated or untreated).||percentage of participants|||Number
814474|NCT01088438|Primary|Probing for Biomedical Issues|Probability that the learner probes biomedical red flags raised in standardized patient encounters undertaken at assessment at end of subinternship. Each learner undertakes four encounters, each of which presents a biomedical red flag that may or may not be probed; in a small number of cases, the standardized patient was ill and the learner undertook fewer than four encounters as a result. Assessment of probing is made by an investigator blinded to learner's assignment to group.|1 month|ITT||proportion of encounters|Participants|95% Confidence Interval|Number
814475|NCT01088438|Primary|Probing for Contextual Issues|Probability that the learner probes contextual red flags raised in standardized patient encounters undertaken at assessment at end of subinternship. Each learner undertakes four encounters, each of which presents a contextual red flag that may or may not be probed; in a small number of cases, the standardized patient was ill and the learner undertook fewer than four encounters as a result. Assessment of probing is made by an investigator blinded to learner's assignment to group.|1 month|ITT||proportion of encounters|Participants|95% Confidence Interval|Number
814476|NCT01088438|Primary|Developing an Appropriate Treatment Plan (for Contextual Variant of Encounters)|Probability that the learner writes a correct treatment plan for the standardized patient encounters undertaken at assessment at end of subinternship that include contextual red flags. All learners are scheduled to see 4 encounters, based on combinations of four cases and four potential variants (baseline, biomedical, contextual, biocontextual) with counterbalancing by study month; each has a single contextual variant encounter. Treatment plans are assessed by an investigator blinded to the learner's assignment to intervention or control group.|1 month|ITT. In one case, a participant did not receive a contextual variant encounter because the standardized patient was ill, and this encounter is excluded.||proportion of contextual encounters|Participants|95% Confidence Interval|Number
814477|NCT01088464|Primary|PK: Vss of Necitumumab After Multiple Doses|Vss is that amount of plasma in which the study drug needs to be dissolved to attain a steady state drug concentration. Data did not allow calculation of Vss for participants in Cohorts 1 and 3.|Cycle 1, Day 29; For Cohorts 1, 2 and 3: predose (prior to fourth infusion for Cohorts 1 and 3; prior to third infusion for Cohort 2), immediately after end of infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 h after end of infusion|All participants who received multiple doses of study drug and had Vss values for Day 29 of Cycle 1. Vss of necitumumab was not assessed for participants in Cohorts 1 and 3, due to the irregular dosing regimen.||mL||Geometric Coefficient of Variation|Geometric Mean
814490|NCT01088464|Primary|Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of Necitumumab After a Single Dose||Cycle 1, Day 1; Cohorts 1 and 3: predose, immediately after end of infusion, 0.5, 1, 2, 6, 24, 96 and 168 hours (h) after end of infusion. Cohort 2: predose, immediately after infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 h after end of infusion|All participants who received single dose of study drug and had Cmax values for Day 1 of Cycle 1.||micrograms per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
814478|NCT01088464|Primary|PK: Steady-State Volume of Distribution (Vss) of Necitumumab After Single Dose|Vss is that amount of plasma in which the study drug needs to be dissolved to attain a steady state drug concentration. Vss was not analyzed for participants in Cohorts 1 and 3 as Vss is derived from AUC (0-∞). AUC(0-∞) was calculated only for participants in Cohort 2 as the percentage of AUC extrapolated beyond tlast was greater than 30% for the remaining participants.|Cycle 1, Day 1; Cohorts 1 and 3: predose, immediately after end of infusion, 0.5, 1, 2, 6, 24, 96 and 168 h after end of infusion. Cohort 2: predose, immediately after end of infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 h after end of infusion|All participants who received single dose of study drug and had Vss values for Day 1 of Cycle 1. Vss of necitumumab was not assessed for participants in Cohorts 1 and 3, due to the irregular dosing regimen.||milliliters (mL)||Geometric Coefficient of Variation|Geometric Mean
814479|NCT01088464|Primary|PK: CL of Necitumumab After Multiple Doses|CL is defined as the volume of plasma that is cleared of study drug per unit time. Data did not allow calculation of CL for participants in Cohorts 1 and 3.|Cycle 1, Day 29; For Cohorts 1, 2 and 3: predose (prior to fourth infusion for Cohorts 1 and 3; prior to third infusion for Cohort 2), immediately after end of infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 h after end of infusion|All the participants who received multiple doses of study drug and had CL values for Day 29 of Cycle 1. CL of necitumumab was not assessed for participants in Cohorts 1 and 3, due to the irregular dosing regimen.||mL/h||Geometric Coefficient of Variation|Geometric Mean
814480|NCT01088464|Primary|PK: Clearance (CL) of Necitumumab After a Single Dose|CL is defined as the volume of plasma that is cleared of study drug per unit time. CL was not analyzed for participants in Cohorts 1 and 3 as CL is derived from AUC(0-∞). AUC(0-∞) was calculated only for participants in Cohort 2 as the percentage of AUC extrapolated beyond tlast was greater than 30% for the remaining participants.|Cycle 1, Day 1; Cohorts 1 and 3: predose, immediately after end of infusion, 0.5, 1, 2, 6, 24, 96 and 168 h after end of infusion. Cohort 2: predose, immediately after end of infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 h after end of infusion|All the participants who received single dose of study drug and had CL values for Day 1 of Cycle 1. No participant of Cohorts 1 and 3 were analyzed for CL on Day 1 of Cycle 1, due to fraction of data outside tlast >30%||milliliters per hour (mL/h)||Geometric Coefficient of Variation|Geometric Mean
814481|NCT01088464|Primary|PK: t½ of Necitumumab After Multiple Doses|The t½ is defined as the time taken for study drug in blood to decrease to half of its concentration.|Cycle 1, Day 29; For Cohorts 1, 2 and 3: predose (prior to fourth infusion for Cohorts 1 and 3; prior to third infusion for Cohort 2), immediately after end of infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 h after end of infusion|All the participants who received multiple doses of study drug and had t½ values for Day 29 of Cycle 1.||h||Geometric Coefficient of Variation|Geometric Mean
814482|NCT01088464|Primary|PK: Half-Life (t½) of Necitumumab After a Single Dose|The t½ is defined as the time taken for study drug in blood to decrease to half of its concentration.|Cycle 1, Day 1; Cohorts 1 and 3: predose, immediately after end of infusion, 0.5, 1, 2, 6, 24, 96 and 168 h after end of infusion. Cohort 2: predose, immediately after end of infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 h after end of infusion|All participants who received single dose of study drug and had t½ values for Day 1 of Cycle 1.||h||Geometric Coefficient of Variation|Geometric Mean
814483|NCT01088464|Primary|PK: Area Under the Concentration-Time Curve From Time 0 to 336 h Postdose [AUC(0-336)] of Necitumumab After Multiple Doses|Steady state AUC(0-336) values are reported.|Cycle 1, Day 29; For Cohorts 1, 2 and 3: predose (prior to fourth infusion for Cohorts 1 and 3; prior to third infusion for Cohort 2), immediately after end of infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 h after end of infusion|All the participants who received multiple doses of study drug and had AUC(0-336) values for Day 29 of Cycle 1.||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
814484|NCT01088464|Secondary|Immunogenicity (IK): Number of Participants With Treatment-Emergent Anti-IMC-11F8 Antibodies|Treatment-emergent samples were defined as samples which showed at least 4-fold difference (2 dilution increase) at post-baseline in IK titer over the baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20).|For Cohorts 1, 2 and 3: Prior to first infusions of Cycles 1, 2, and 4 and at the 30-day follow-up visit (+7 days) after the last dose of study drug|All participants who received any quantity of study drug.||participants|||Number
814485|NCT01088464|Primary|PK: Area Under the Concentration-Time Curve From Time 0 to Infinity [AUC(0-∞)] of Necitumumab After a Single Dose|AUC(0-∞) was calculated only for participants in Cohort 2 as the percentage of AUC extrapolated beyond tlast was greater than 30% for all the remaining participants.|Cycle 1, Day 1; Cohorts 1 and 3: predose, immediately after end of infusion, 0.5, 1, 2, 6, 24, 96 and 168 h after end of infusion. Cohort 2: predose, immediately after end of infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 h after end of infusion|"All participants who received single dose of study drug and had evaluable AUC(0-∞) values for Day
1 of Cycle 1. No participant of Cohorts 1 and 3 were analyzed for AUC(0-∞) on Day 1 of Cycle 1, due to fraction of data outside tlast >30%"||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
814486|NCT01088464|Primary|PK: Area Under the Concentration-Time Curve From Time 0 to Last Time Point [AUC (0-tlast)] of Necitumumab After a Single Dose||Cycle 1, Day 1; Cohorts 1 and 3: predose, immediately after end of infusion, 0.5, 1, 2, 6, 24, 96 and 168 h after end of infusion. Cohort 2: predose, immediately after end of infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 h after end of infusion|All participants who received single dose of study drug and had evaluable AUC(0-∞) values for Day 1 of Cycle 1.||micrograms*hour/milliliter (µg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
814487|NCT01088464|Primary|PK: Cmin of Necitumumab After Multiple Doses|Cmin was calculated prior to the last dose of the initial 6-week treatment cycle.|Cycle 1; Cohorts 1and 3: prior to fourth infusion. Cohort 2: prior to third infusion|All participants who received multiple doses of study drug and had Cmin serum concentrations prior to last dose of Cycle 1.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
814488|NCT01088464|Primary|PK: Minimum Concentration (Cmin) of Necitumumab After a Single Dose|Cmin is defined as the minimum concentration the drug achieved after administration of first infusion and prior to the administration of second infusion.|Cycle 1; Cohorts 1, 2 and 3: prior to second infusion|All participants who received single dose of study drug and had Cmin serum concentrations analyzed prior to administration of second dose.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
814926|NCT01086215|Primary|Rethrombosis|The number of patients affected by rethrombosis of the treated vessels (first episode) throughout a 12 Month Follow-Up.|3 Month , 6 Month and 12 Month Follow Up|||participants|||Number
814491|NCT01088464|Primary|Number of Participants With 1 or More Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs)|Data presented are the number of participants who experienced 1 or more TEAEs or SAEs regardless of causality. An adverse event was considered as TEAE if it occurred any time after the administration of the first dose of study drug or up to 30 days after the last dose of study treatment or if it occurred prior to the first dose and worsened while on treatment. A summary of SAEs and other non-SAEs regardless of causality is located in the Reported Adverse Events module.|Baseline up to 24 weeks plus 30 days post last dose of study drug|All participants who received any quantity of study drug.||participants|||Number
814492|NCT01088503|Primary|Factors Associated With Initial ADP Receptor Inhibitor Selection at Enrollment: Duke Coronary Artery Disease (CAD) Index|The Duke CAD Index is a validated composite measure of angiographic burden, which assigns prognostic weights 1 through 100. Higher scores indicate greater angiographic burden and are associated with poorer prognosis.|Day 0 (study enrollment)|All enrolled participants who had Duke CAD Index completed.||units on a scale||Standard Deviation|Mean
814493|NCT01088503|Primary|Factors Associated With Initial ADP Receptor Inhibitor Selection at Enrollment: Pre-Procedure Hemoglobin||Day 0 (study enrollment)|All enrolled participants who had pre-procedure hemoglobin evaluation.||grams/deciliter (g/dL)||Standard Deviation|Mean
814494|NCT01088503|Secondary|Resource Use Patterns, Cumulative Total Medical Costs, and Cost Effectiveness||15 months|Zero participants were analyzed. Exploratory analysis of resource use patterns, cumulative total medical costs, and cost effectiveness was dependent on effectiveness in the primary outcome. As there was no effectiveness on the primary outcome demonstrated, no analysis of these outcome measure was conducted.|||||
814495|NCT01088503|Secondary|Percentage of Participants With Definite or Probable Stent Thrombosis (ST) Events|Academic Research Consortium (ARC) criteria were used to define ST. Definite ST is angiographic or pathologic confirmation of partial or total thrombotic occlusion within the peri-stent region, and at least 1 of the following additional criteria: acute ischemic symptoms; ischemic electrocardiogram changes; elevated cardiac biomarkers. Probable ST is any unexplained death within 30 days of stent implantation; any MI, which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of ST and in the absence of any other obvious cause. Events that occurred more than 7 days after medication was switched or discontinued were excluded from the analysis. Observed (unadjusted) percentages of participants with ST events are presented. Kaplan-Meier analysis was used to estimate the percentage of participants with a definite or probable ST event.|Baseline through 15 months|Participants who were treated with prasugrel or clopidogrel.||percentage of participants||95% Confidence Interval|Number
814496|NCT01088503|Secondary|Percentage of Participants With MACE Over 1, 6 and 15 Months|MACE is defined as a composite of all-cause death, MI, stroke, or unplanned coronary revascularization. Events that occurred more than 7 days after medication was switched or discontinued were excluded from the analysis. Observed (unadjusted) percentages of participants with MACE are presented. Kaplan-Meier analysis was used to estimate the percentage of participants with a MACE event.|Baseline through 1, 6 and 15 months|Participants who were treated with prasugrel or clopidogrel. Participants with MACE events dated prior to index PCI were excluded from the analysis.||percentage of participants||95% Confidence Interval|Number
814497|NCT01088503|Secondary|Percentage of Participants With MACE and Who Had No Prior History of Transient Ischemic Attack (TIA)/Stroke, Weigh ≥60 Kilograms (kg), and Are Age <75 Years|MACE is defined as a composite of all-cause death, MI, stroke, or unplanned coronary revascularization. Events that occurred more than 7 days after medication was switched or discontinued were excluded from the analysis. Observed (unadjusted) percentages of participants with MACE, as well as the statistical analyses adjusted for baseline cohort differences, are presented. Percentage of participant = (number of participants with events / number of participants treated) * 100.|Baseline through 12 months|Participants who were treated with prasugrel or clopidogrel. Participants with MACE events dated prior to index PCI were excluded from the analysis.||percentage of participants||95% Confidence Interval|Number
814498|NCT01088503|Secondary|Percentage of Participants With Cumulative Severe or Moderate Bleeding Events|Bleeding events were collected utilizing the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO) definition of bleeding. Non-coronary artery bypass grafting (CABG)-related GUSTO severe or life-threatening bleeding is any intracranial hemorrhage (ICH) OR any bleeding event resulting in substantial hemodynamic compromise requiring treatment. Non-CABG-related GUSTO moderate bleeding is any bleeding event resulting in the need for transfusion that is not considered a GUSTO severe or life-threatening bleed. Additional bleeding events are fatal bleeding or ICH, or any non -fatal surgical-related bleeding events leading to ≥4 units of red cell transfusion. Observed (unadjusted) percentages of participants with bleeding events, as well as the statistical analyses adjusted for baseline cohort differences, are presented. Percentage of participants = (number of participants with events / number of participants treated) * 100.|Baseline, 1, 6, 12 and 15 months|Participants who were treated with prasugrel or clopidogrel. Participants with bleeding events dated prior to index PCI were excluded from the analysis. The analysis was based on the initial treatment assignment, regardless of whether or not the participants switched or discontinued that treatment.||percentage of participants||95% Confidence Interval|Number
814499|NCT01088503|Primary|Factors Associated With Initial Adenosine Diphosphate (ADP) Receptor Inhibitor Selection at Enrollment|Factors are drug-eluting stent (DES) vs. bare metal stent (BMS) placement, other (no stent) vs. BMS, STEMI, other race, cardiogenic shock occurred within 24 hours, male, European Quality of Life Questionnaire-5 Dimension Health State Score (EQ-5D) - United States (US) Index =1 vs. <1, married, diabetes, and other vs. BMS placement. The EQ-5D US index is a participant-rated, health-related, quality-of-life instrument based on US population. Scores range from -0.11 to 1.0 with 1.0 = perfect health.|Day 0 (study enrollment)|All enrolled participants||participants|||Number
814500|NCT01088503|Primary|Percentage of Participants With Major Adverse Cardiovascular Events (MACE)|MACE is defined as a composite of all-cause death, myocardial infarction (MI), stroke, or unplanned coronary revascularization. Events that occurred more than 7 days after medication was switched or discontinued were excluded from the analysis. Observed (unadjusted) percentages of participants with MACE, as well as the statistical analyses adjusted for baseline cohort differences, are presented. Percentage of participants = (number of participants with events in 12 months/ number of participants treated) * 100.|Baseline through 12 months|Participants who were treated with prasugrel or clopidogrel. Participants with MACE events dated prior to index PCI were excluded from the analysis.||percentage of participants||95% Confidence Interval|Number
814501|NCT01088529|Secondary|Number of Participants With Prostate-Specific Antigen Response|The table below shows number of participants in each treatment group who achieved a prostate-specific antigen (PSA) response defined as a drop in PSA value to less than or equal to 0.2 ng/mL.|Cycle 3 Day 1|"Intent-to-treat (ITT) analysis set, which included all participants who were randomized to study. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure."||participants|||Number
814502|NCT01088529|Secondary|Number of Participants With a Positive Surgical Margin at Radical Prostatectomy|The table below shows number of participants in each treatment group who had positive surgical margins. A positive surgical margin is defined as tumor extending to the inked-surface or margin of the prostate.|At the end of Cycle 3 (at radical prostatectomy)|Intent-to-treat (ITT) analysis set, which included all participants who were randomized to study.||participants|||Number
814503|NCT01088529|Primary|Number of Participants With a Pathology Tumor Stage of Less Than or Equal to Prostate Cancer Stage at Which the Tumor is Confined to the Prostate (pT2)|The table below shows number of participants in each treatment group with a pathology tumor stage less than or equal to pT2.|At the end of Cycle 3 (at radical prostatectomy)|Intent-to-treat (ITT) analysis set, which included all participants who were randomized to study.||participants|||Number
814504|NCT01088646|Primary|Percentage of Capsule Placement Success Using PillCam® Express Capsule Endoscopy Delivery System||up to 7 days||||||
814505|NCT01088646|Primary|Number of Participants With Successful Capsule Placment Into the Duodenum Using Capsule Delivery System|The number of capsules that successfully were in the duodenum as indicated by video images|up to 7 days|||participants|||Number
814506|NCT01088672|Secondary|Mortality at 90 Days|All cause mortality through 90 days post procedure.|90-day|||participants|||Number
814507|NCT01088672|Secondary|Clinical Outcomes at 90 Days|"Good clinical outcome is defined as an modified Rankin Scale (mRS) score of 0-2 at 90 days.
mRS 0-2 indicates functional independence 0 - No symptoms.
- No significant disability. Able to carry out all usual activities, despite some symptoms.
- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
- Moderate disability. Requires some help, but able to walk unassisted.
- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
- Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
- Dead.
https://en.wikipedia.org/wiki/Modified_Rankin_Scale"|90-day|||percentage of subjects with mrs 0-2|||Number
814508|NCT01088672|Primary|Revascularization Status|"Revascularization, defined as at least TICI 2a in the vascular territory treated at end of the neuro interventional procedure
Thrombolysis in Cerebral Infarction (TICI) grading system for perfusion (ie blood flow through a vessel) Grade 0:No Perfusion. No antegrade flow beyond the point of occlusion. Grade 1:Penetration With Minimal Perfusion. Grade 2:Partial Perfusion. Grade 2a:Only partial filling (<2/3) of the entire vascular territory is visualized.
Grade 2b:Complete filling of all of the expected vascular territory is visualized, but slower ...
Grade 3:Complete Perfusion. For complete info see Higashida RT, Furlan AJ, Roberts H, Tomsick T, Connors B et al. (2003) Trial design and reporting standards for intra-arterial cerebral thrombolysis for acute ischemic stroke. Stroke 34: e109-e137.10.1161/01.STR.0000082721.62796.09 PubMed: 12869717[PubMed]"|Post-procedure, immediate=at the end of the procedure, per last angiogram during treatment|||percentage of subjects TICI 2 or >|||Number
814509|NCT01088711|Secondary|Plasma Glucose Concentration|Post-prandial glucose concentration is presented as a weighted average of the 0.25, 0.5, 1, 2, and 4 hour post-dose time points. Glucose concentration was calculated as area under the curve (AUC) for the 4-hr post-dose time period (AUC0-4 hrs); this AUC was then divided by the time interval of 4 hours to obtain weighted average glucose concentration. Log scale data were then back-transformed to obtain LS means.|Through 4 hours post dose on Day 21|Data from obese healthy participants (Panel A) and obese T2D participants (Panel B) 4 hours post dose on Day 21 were pooled according to treatment. All participants who received omarigliptin or placebo are included.||mg/dL||95% Confidence Interval|Least Squares Mean
814510|NCT01088711|Secondary|WAA Total GLP-1 Concentration|WAA total GLP-1 concentration was based on the 0.25, 0.5, 1, 2, and 4 hour timepoints. WAA was calculated as AUC0-4 hrs; this AUC was then divided by the time interval of 4 hours to obtain WAA. Log scale data were then back-transformed to obtain LS means.|Through 4 hours post dose on Day 21|Data from obese healthy participants (Panel A) and obese T2D participants (Panel B) 4 hours post dose on Day 21 were pooled according to treatment. All participants who received omarigliptin or placebo are included.||pmol/L||95% Confidence Interval|Least Squares Mean
814511|NCT01088711|Secondary|WAA Active Glucagon-like Peptide-1 (GLP-1) Concentration|Weighted average augmentation (WAA) active GLP-1 concentration was based on the 0.25, 0.5, 1, 2, and 4 hour timepoints. WAA was calculated as area under the curve (AUC) for the 4-hr post-dose time period (AUC0-4 hrs); this AUC was then divided by the time interval of 4 hours to obtain WAA. Log scale data were then back-transformed to obtain LS means.|Through 4 hours post dose on Day 21|Data from obese healthy participants (Panel A) and obese T2D participants (Panel B) 4 hours post dose on Day 21 were pooled according to treatment. All participants who received omarigliptin or placebo are included.||pmol/L||95% Confidence Interval|Least Squares Mean
814512|NCT01088711|Secondary|Percent Inhibition of DPP-4 After Day 22|Percent DPP-4 inhibition at 168 hours after the Day 22 dose (from baseline [pre-dose on Day 1]) was compared in healthy and T2D participants receiving omarigliptin or placebo.|168 hours post dose on Day 22|No data from obese healthy participants (Panel A) were collected after pre-dose on Day 22. Therefore, data are presented only for obese T2D participants (Panel B) 168 hours post-dose on Day 22.||Percent DPP-4 inhibition||95% Confidence Interval|Geometric Mean
814513|NCT01088711|Secondary|Percent Inhibition of Dipeptidyl Peptidase-4 (DPP-4) After Day 15|Percent DPP-4 inhibition at 168 hours after the Day 15 dose (from baseline [pre-dose on Day 1]) was compared in healthy and T2D participants receiving omarigliptin or placebo.|168 hours post-dose on Day 15|Data from obese healthy participants (Panel A) and obese T2D participants (Panel B) 168 hours post-dose on Day 15 were pooled according to treatment. Predose data from Day 1 were missing from 2 participants.||Percent DPP-4 inhibition||95% Confidence Interval|Geometric Mean
814514|NCT01088711|Primary|Number of Participants Withdrawing From Study Therapy Due to an AE||Up to Day 22|AEs were monitored in all obese healthy (Panel A) and T2D (Panel B) participants who received omarigliptin 50 mg or placebo.||Participants|||Number
830143|NCT01227629|Secondary|D-dimer: Difference From Baseline|Difference in D-dimer from baseline to last available value|baseline and 12 weeks|All randomised patients, only per-protocol data included.||ng/ml||Standard Deviation|Mean
814516|NCT01081626|Secondary|Number of Participants Who Answered Ease of Use of Gonal-f® Pen Questionnaire|Ease of use of Gonal-f® pen was assessed through a questionnaire consisting of 23 questions and the number of participants who responded to the questionnaire was recorded.|On hCG administration day (end of stimulation cycle {less than or equal to [<=] 35 days})|The ITT population included all the participants who received at least 1 dose of study medication, had 1 efficacy assessment and did not have any protocol criteria violations or did not receive a wrong treatment.||participants|||Number
814517|NCT01081626|Secondary|Total Follicle Stimulating Hormone (FSH) Dose||End of stimulation cycle (less than or equal to [<=] 35 days|The ITT population included all the participants who received at least 1 dose of study medication, had 1 efficacy assessment and did not have any protocol criteria violations or did not receive a wrong treatment. Number of participants analyzed (N) included participants who were evaluated for this particular measure.||IU||Standard Deviation|Mean
814518|NCT01081626|Secondary|Duration of Follicle Stimulating Hormone (FSH)||End of stimulation cycle (less than or equal to [<=] 35 days)|The ITT population included all the participants who received at least 1 dose of study medication, had 1 efficacy assessment and did not have any protocol criteria violations or did not receive a wrong treatment. Number of participants analyzed (N) included participants who were evaluated for this particular measure.||Days||Standard Deviation|Mean
814519|NCT01081626|Secondary|Number of Participants With Clinical Pregnancies|Clinical pregnancy was defined as pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It includes ectopic pregnancy.|Day 0 (first dose) up to Days 35-42 post hCG administration (end of stimulation cycle {less than or equal to [<=] 35 days})|The ITT population included all the participants who received at least 1 dose of study medication, had 1 efficacy assessment and did not have any protocol criteria violations or did not receive a wrong treatment. Number of participants analyzed (N) included participants who were evaluated for this particular measure.||participants|||Number
814520|NCT01081626|Secondary|Number of Participants With Cancelled Cycles|Participants with cancelled cycles were those who did not achieve adequate follicular formation (at least 17 mm) for hCG administration.|End of stimulation cycle (less than or equal to [<=] 35 days)|The ITT population included all the participants who received at least 1 dose of study medication, had 1 efficacy assessment and did not have any protocol criteria violations or did not receive a wrong treatment.||participants|||Number
814521|NCT01081626|Secondary|Number of Participants Who Received Human Chorionic Gonadotropin (hCG)||End of stimulation cycle (less than or equal to [<=] 35 days)|The ITT population included all the participants who received at least 1 dose of study medication, had 1 efficacy assessment and did not have any protocol criteria violations or did not receive a wrong treatment.||participants|||Number
814522|NCT01081626|Secondary|Number of Participants With Injection Tolerability|Participants who did not show any injection site reactions such as pain, redness, bruises, swelling and irritation were considered to have injection tolerability.|Day 0 (first dose) up to Days 35-42 post hCG administration (end of stimulation cycle {less than or equal to [<=] 35 days})|The safety population included all the participants who received at least 1 dose of study medication and had 1 follow-up visit. Number of participants analyzed (N) included participants who were evaluated for this particular measure.||participants|||Number
814523|NCT01081626|Secondary|Number of Participants With Multiple Pregnancies|Multiple pregnancy is a pregnancy where more than one fetus develops simultaneously in the womb. There are two types of twinning—identical and fraternal. Identical twins represent the splitting of a single fertilized zygote (union of two gametes or male/female sex cells that produce a developing fetus) into two separate individuals.|Day 0 (first dose) up to Days 35-42 post hCG administration (end of stimulation cycle {less than or equal to [<=] 35 days})|The ITT population included all the participants who received at least 1 dose of study medication, had 1 efficacy assessment and did not have any protocol criteria violations or did not receive a wrong treatment. Number of participants analyzed (N) included participants who were evaluated for this particular measure.||participants|||Number
814524|NCT01081626|Secondary|Number of Participants With Adverse Events (AEs)|AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug.|Day 0 (first dose) up to Days 35-42 post hCG administration (end of stimulation cycle {less than or equal to [<=] 35 days})|The safety population included all the participants who received at least 1 dose of study medication and had 1 follow-up visit.||participants|||Number
814525|NCT01081626|Secondary|Number of Participants With Multi-follicular Development|Multi-follicular development was defined as the development of more than 3 follicles >= 15 mm in diameter at or before Days 35-42 of stimulation period assessed by means of a transvaginal ultrasound scan.|Day 0 (first dose) up to Days 35-42 post hCG administration (end of stimulation cycle {less than or equal to [<=] 35 days})|The ITT population included all the participants who received at least 1 dose of study medication, had 1 efficacy assessment and did not have any protocol criteria violations or did not receive a wrong treatment.||participants|||Number
814526|NCT01081626|Primary|Percentage of Participants With a Mono-follicular Development|Mono-follicular development was defined as the development of only 1 follicle of greater than or equal to (>=) 17 millimeter (mm) diameter and no more than 2 other follicles larger than 14 mm in diameter at or before Days 35-42 of stimulation period assessed by means of a transvaginal ultrasound scan.|Day 0 (first dose) up to Days 35-42 post human chorionic gonadotropin [hCG] administration (end of stimulation cycle {less than or equal to [<=] 35 days})|The Intention-To-Treat (ITT) population included all the participants who received at least 1 dose of study medication, had 1 efficacy assessment and did not have any protocol criteria violations or did not receive a wrong treatment.||percentage of participants|||Number
814527|NCT01081665|Primary|Safety Evaluation of Paricalcitol by Recording the Number of Days Hospitalized|The mean (average) number of days hospitalized per participant for those hospitalized during the study.|Baseline to Month 24 Visit|Based on participant hospitalizations during the study where the length of hospitalization was known (82 participants total).||days||Standard Deviation|Mean
814592|NCT01089023|Secondary|Time to DAS28 Response by DAS28 Category|Time to response is the number of days from date of first infusion to date of event. DAS28 response was defined as achievement of Low Disease Activity (DAS28 ≥2.6 to ≤3.2), Remission (DAS28 <2.6), or Clinically Meaningful Improvement (change of >1.2 from baseline).|Weeks 4, 8, 12, 16, 20, and 24|All the participants who were administered treatment at each visit were considered during the analysis.||days||Standard Error|Mean
814528|NCT01081665|Secondary|To Estimate the Incidence of (S)AEs/(S)ADRs|The number of adverse events, serious adverse events (including death), adverse drug reactions, and serious adverse drug reactions experienced by participants during the study are summarized. Adverse events include any events reported regardless of whether or not they were considered related to the study drug. Adverse drug reactions include events where a causal relationship between the drug and the occurence of the event is suspected. For additional details see the Reported Adverse Events section.|Baseline to Month 24 Visit|Analysis included all enrolled participants.||participants|||Number
814529|NCT01081665|Secondary|The Incidence of Clinically Significant Elevation of Calcium-phosphorous (Ca x P) Product|The number of participants with clinically significant levels of calcium-phosphorous product (Ca x P), defined as serum calcium-phosphorous product levels greater than 65 milligrams squared per deciliters squared (mg^2/dL^2) at 2 consecutive measurements.|Baseline to Month 24 Visit|Analysis included all enrolled participants.||Participants|||Number
814530|NCT01081665|Secondary|The Incidence of Clinically Significant Hyperphosphatemia|The number of participants with clinically significant hyperphosphatemia (too much phosphorous in the blood), defined as serum phosphorous levels greater than 6.5 milligrams per deciliter (mg/dL) at 2 consecutive measurements.|Baseline to Month 24 Visit|Analysis included all enrolled participants.||Participants|||Number
814531|NCT01081665|Secondary|The Incidence of Clinically Significant Hypercalcemia|The number of participants with clinically significant hypercalcemia (too much calcium in the blood), defined as a corrected serum calcium level greater than 11.0 milligrams per deciliter (mg/dL) at 2 consecutive measurements.|Baseline to Month 24 Visit|Analysis included all enrolled participants.||Participants|||Number
814532|NCT01081665|Secondary|The Proportion of Patients Achieving Therapeutic Success (Defined as 40% Reduction in Base Parathormone Level and/or Parathormone Level <300 pg/ml)|Therapeutic success of paricalcitol treatment was defined as a 40% decrease from the baseline measurement in the level of intact parathyroid hormone (also known as iPTH or parathormone) and/or a serum intact parathyroid hormone level less than 300 picograms per milliliter (pg/mL) for at least 2 consecutive available measurements during the 24-month follow-up period.|Baseline to Month 24 Visit|Analysis based on the evaluable population, defined as participants with baseline and at least 2 post-baseline parathormone measurements at the 24-month post-treatment follow-up visit.||percentage of participants|||Number
814533|NCT01081665|Primary|Safety Evaluation of Paricalcitol by Recording the Number of Hospitalizations|The number of participants who were hospitalized during the study and the number of hospitalizations are summarized.|Baseline to Month 24 Visit|Analysis included all enrolled participants.||participants|||Number
814534|NCT01081769|Primary|Number of Participants With a Relapse Event|Number of participants with a relapse event with relapses evaluated according the Csernansky criteria. A patient was considered to have relapsed if they met one or more of the following criteria: (1) psychiatric hospitalization; (2) an increase in the level of psychiatric care and an increase of 25% from baseline in the PANSS total score (or an increase of 10 points if the baseline score was 40 or less); (3) deliberate self-injury; (4) suicidal or homicidal ideation that was clinically significant in the investigator’s judgment; (5) violent behavior resulting in clinically significant injury to another person or property damage; (6) substantial clinical deterioration, defined as a change score of 6 (“much worse”) or 7 (“very much worse”) on the Clinical Global Impressions Scale (CGI-C); and/or (7) the required dose of the antipsychotic exceeds the maximum approved dose.|from baseline (Day 1 of core phase) up to maximally 24 months|all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment||number of participants|||Number
814535|NCT01081769|Secondary|Change From Baseline in Physician’s Treatment Satisfaction|Physician’s treatment satisfaction was assessed using the physician’s treatment satisfaction scale which is designed to rate 4 aspects of treatment (efficacy, safety, mode of administration, and overall satisfaction), each on a scale ranging from 1 (extremely satisfied) to 7 (extremely dissatisfied).|baseline (day 1 of core phase), month 12 and 24|all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment||units on a scale||Standard Deviation|Mean
814536|NCT01081769|Secondary|Change From Baseline in Patient’s Treatment Satisfaction|Patient’s satisfaction with medication was assessed using the Treatment Satisfaction Questionnaire for Medication (TSQM). The TSQM is divided into 4 subscales (effectiveness, side effects, convenience, and global satisfaction), with the value of each subscale ranging from 0 to 100. Higher scores indicate greater treatment satisfaction.|baseline (day 1 of core phase), month 12 and 24|all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment||units on a scale||Standard Deviation|Mean
814537|NCT01081769|Secondary|Change From Baseline in Subjective Well-Being Under Neuroleptics-Short Form (SWN-S) Total Score|The SWN-S is a patient self-rated scale developed to measure the subjective well-being for the previous 7 days of a patient under neuroleptic treatment. The SWN-S consists of 20 items (each item is rated from 1=not at all to 6=very much). The total score ranges from 20 to 120 with higher score indicating greater subjective well-being.|baseline (day 1 of core phase), month 6, 12 and 24|all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment||units on a scale||Standard Deviation|Mean
814538|NCT01081769|Secondary|Change From Baseline in EuroQol 5-Dimensional Questionnaire (EQ-5D) Index Score|"The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating full health and 0 representing dead. A higher score indicates an improvement in health in the Health Status Index."|baseline (day 1 of core phase), month 6, 12 and 24|all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment||units on a scale||Standard Deviation|Mean
814539|NCT01081769|Secondary|Change From Baseline in EuroQol 5-Dimensional Questionnaire (EQ-5D) VAS Score|The EQ-5D VAS records the respondent’s self-rated health on a vertical, visual analog scale, with 0 representing the worst imaginable health state and 100 representing the best imaginable health state. The EQ VAS is used as a quantitative measure of health outcome as judged by the individual respondent.|baseline (day 1 of core phase), month 6, 12 and 24|all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment||units on a scale||Standard Deviation|Mean
814540|NCT01081769|Secondary|Change From Baseline in Short Form-36 Health Survey (SF-36)|The Short Form-36 Health Survey (SF-36) is a measure of Participant-reported health status. It is a 36-item questionnaire measuring 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Two summary scale scores are computed based on weighted combinations of the 8 subscale scores: the Physical Component Summary and the Mental Component Summary. Each summary scale score ranges from 0 (worst) to 100 (best), with higher scores reflecting better health-related functional status.|baseline (day 1 of core phase), month 6, 12 and 24|all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment||units on a scale||Standard Deviation|Mean
814541|NCT01081769|Secondary|Changes From Baseline in Personal and Social Performance (PSP) Total Score|The Personal and Social Performance (PSP) scale assesses degree of a participant’s dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. Score ranges from 1 to 100, divided into 10 equal intervals to rate degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Based on 4 domains there will be 1 total score. Participants with score of 71 to 100 have mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision.|baseline (day 1 of core phase), month 1, 3, 6, 9, 12, 15, 18, 21 and 24|all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment||units on a scale||Standard Deviation|Mean
814542|NCT01081769|Secondary|Clinical Global Impression-Change (CGI-C)|The Clinical Global Impression-Change (CGI-C) rating scale is used to rate the change in severity of the patient's illness compared to baseline (day 1 of core phase) on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).|Month 24 and endpoint|all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment||percentage of participants|||Number
814543|NCT01081769|Secondary|Change From Baseline in Clinical Global Impression Severity (CGI-S) Score|"The Clinical Global Impression Severity (CGI-S) rating scale is a 7 point global clinical assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher scores indicate higher impression of illness severity."|Baseline (day 1 of core phase), day 8, month 1, 2, 3, 4, 6, 9, 12, 15, 18, 21, 24|all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment||units on a scale||Standard Deviation|Mean
814544|NCT01081769|Secondary|Change From Baseline in PANSS Marder Factor Scores|Change from baseline in schizophrenia symptoms were assessed through the following PANSS factor scores as described by Marder: (1) positive symptoms (range 8-56): sum of delusions, hallucinatory behavior, grandiosity, suspiciousness, stereotyped thinking, somatic concern, unusual thought content, lack of judgment and insight; (2) negative symptoms (range 7-49): sum of blunted affect, emotional withdrawal, poor rapport, passive social withdrawal, lack of spontaneity, motor retardation, and active social avoidance; (3) disorganized thoughts (range 7-49): sum of conceptual disorganization, difficulty in abstract thinking, mannerisms and posturing, disorientation, poor attention, disturbance of volition, and preoccupation; (4) uncontrolled hostility/excitement (range 4-28): sum of excitement, hostility, uncooperativeness and poor impulse control; (5) anxiety/depression (range 4-28): sum of anxiety, guilt feelings, tension, and depression. Higher scores indicate higher severity of symptoms|Baseline (day 1 of core phase), day 8, month 12 and 24|all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment||units on a scale||Standard Deviation|Mean
814545|NCT01081769|Secondary|Change From Baseline in PANSS Subscale Score|Change from baseline in positive symptom, negative symptom and general psychopathology subscales of the PANSS scale. The PANSS scale is designed to assess symptoms of schizophrenia by means of the 30-items. The PANSS scale provides subscores for 3 subscales, that is, the positive symptoms subscale (7 items, range 7-49), the negative symptoms subscale (7 items, range 7-49), and the general psychopathology subscale (16 items, range 16-112). Each item of the scale is to be scored on a scale of 1 (absent) to 7 (extreme). Higher scores indicate higher severity of schizophrenia symptoms.|Baseline (day 1 of core phase), day 8, month 12, 24|all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment||units on a scale||Standard Deviation|Mean
814546|NCT01081769|Secondary|Change From Baseline in PANSS Total Score|Change from baseline in the PANSS: The PANSS is a 30-item scale (Range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.|Baseline, day 8, month 1, 2, 3, 4, 6, 9, 12, 15, 18, 21, 24|all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment||units on a scale||Standard Deviation|Mean
814547|NCT01081769|Secondary|Percentage of Treatment Responders|The proportion of patients achieving a treatment response, defined as a ≥30% decrease (i.e., improvement) in Positive and Negative Syndrome Scale (PANSS) total score from baseline to endpoint. The PANSS is a 30-item scale (Range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate increased severity of schizophrenia symptoms.|from baseline (day 1 of core phase) up to maximally 24 months|all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment||percentage of participants||95% Confidence Interval|Number
814548|NCT01081769|Primary|Time to First Relapse Event|Number of days from baseline (day 1 of core phase) to relapse as evaluated according the Csernansky criteria. A patient was considered to have relapsed if they met one or more of the following criteria: (1) psychiatric hospitalization; (2) an increase in the level of psychiatric care and an increase of 25 percent (%) from baseline in the Positive And Negative Syndrome Score (PANSS) total score (or an increase of 10 points if the baseline score was 40 or less); (3) deliberate self-injury; (4) suicidal or homicidal ideation that was clinically significant in the investigator’s judgment; (5) violent behavior resulting in clinically significant injury to another person or property damage; (6) substantial clinical deterioration, defined as a change score of 6 (“much worse”) or 7 (“very much worse”) on the Clinical Global Impressions Scale (CGI-C); and/or (7) the required dose of the antipsychotic exceeds the maximum approved dose.|from baseline (Day 1 of core phase) up to maximally 24 months.|all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment||days||Standard Error|Mean
814549|NCT01081795|Secondary|Short Form-36 Health Survey (SF-36) Score|The SF-36 is a survey of participant health. It consists of 8 scaled scores, which are weighted sums of the questions in their section. The 8 sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. Each item is scored on a 0-100 range so that total score ranges from 0-100 with high score indicating more favorable health state. Final evaluation was done at Day 155 or at discontinuation for those participants who discontinued before Day 155.|Baseline (28 days before randomization), Day 29, 85 and final evaluation (FE) (Day 155/early withdrawal [EW])|The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization. Here 'n' signifies those participants who were evaluable for this measure at given time points.||Units on a scale||Standard Deviation|Mean
814550|NCT01081795|Secondary|Percentage of Participants With Response to Study Treatment|Responders were the participants who had at least 50 percent reduction in the average number of monthly migraine attacks.|Month 1, 2, 3, 4, 5 and 6|The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization.||Percentage of participants|||Number
814551|NCT01081795|Secondary|Change From Baseline in the Average Number of Rescue Drug Treatment Days at Month 6|Rescue medications are medicines that may be administered to the participants when efficacy of study drug is not satisfactory, or the effect of study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation. If an aura of migraine, a migraine attack or a non-migraine headache attack occurred during the study period, use of following rescue drugs was permitted: analgesics, NSAIDs, ergotamines, triptans and anti-emetics. Average at Month 6 was calculated by dividing total number of rescue drug treatment days until that month by the total number of days of assessment, multiplied by 28 (a month was equal to 28 days).|Month 6|The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization.||Days||Standard Error|Least Squares Mean
814552|NCT01081795|Secondary|Average Number of Rescue Drug Treatment Days|Rescue medications are administered to participants when efficacy of study drug is not satisfactory, or effect of study drug is too great and is likely to cause a hazard to participant, or to manage an emergency situation. If an aura of migraine, a migraine attack or a non-migraine headache attack occurred during the study period, use of following rescue drugs was permitted: analgesics, non-steroidal anti-inflammatory drugs (NSAIDs), ergotamines, triptans and anti-emetics (drug used to stop vomiting). Average at baseline was calculated by dividing total number of rescue drug treatment days until baseline by the total number of days of assessment, multiplied by 28 (a month was equal to 28 days).|Baseline (28 days before randomization)|The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization.||Days||Standard Deviation|Mean
814553|NCT01081795|Secondary|Change From Baseline in Migraine Attacks (According to 24-Hour Rule) Over Week 19 to Week 22 Period|The change from baseline in average number of migraine attacks (as per 24-hour rule) over Week 19 to Week 22 period was calculated by subtracting the baseline value from the average value of the Week 19 to Week 22 period.|Baseline (28 days before randomization), Week 19 to Week 22 Period|The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization.||Migraine attacks||Standard Error|Least Squares Mean
814554|NCT01081795|Secondary|Change From Baseline in Monthly Migraine Attacks (According to 48-Hour Rule) at Month 1, 2, 3, 4, 5 and 6|As per 48-hour rule, if the symptom of pain due to migraine continues for more than 48 hours, it should be considered as 2 or more migraine attacks considering the maximum duration up to 48 hours. If the interval between the latest migraine attack (ending time) and the previous migraine attack (onset time) is less than 48 hours, the 2 migraine attacks should be considered as 1 migraine attack. If the onset of the migraine was prevented by a rescue drug, it should be considered as 1 migraine attack even if the aura had started.|Baseline (28 days before randomization), Month 1, 2, 3, 4, 5 and 6|The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization.||Migraine attacks||Standard Deviation|Mean
814555|NCT01081795|Secondary|Change From Baseline in Average Number of Monthly Migraine Attacks (According to the Diagnostic Criteria of the International Headache Society) at Month 1, 2, 3, 4, 5 and 6|Migraine is a headache disorder with 2 subtypes: migraine without aura (at least 5 attacks lasting 4-72 hours with at least 2 following characteristics: unilateral location, pulsating quality, moderate/severe pain and either nausea/vomiting or photophobia and phonophobia) and migraine with aura (reversible focal neurological symptoms that develop over 5-20 minutes and last for less than 60 minutes); average at given month was calculated by dividing total number of migraine attacks until that month by the total number of days of assessment, multiplied by 28 (a month was equal to 28 days).|Baseline (28 days before randomization), Month 1, 2, 3, 4, 5 and 6|The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization.||Migraine attacks||Standard Deviation|Mean
814556|NCT01081795|Secondary|Change From Baseline in Average Number of Monthly Headache Days at Month 1, 2, 3, 4, 5 and 6|Headache days were the days when at least 30-minute migraine and non-migraine headache occurred and were calculated from the headache diaries kept by the participants. Average at given month was calculated by dividing total number of headache days until that month by the total number of days of assessment, multiplied by 28 (a month was equal to 28 days).|Baseline (28 days before randomization), Month 1, 2, 3, 4, 5 and 6|The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization.||Days||Standard Deviation|Mean
814557|NCT01081795|Secondary|Change From Baseline in Average Number of Monthly Migraine Attack Days at Month 1, 2, 3, 4, 5 and 6|Migraine is a headache disorder with 2 subtypes: migraine without aura (at least 5 attacks lasting 4-72 hours with at least 2 following characteristics: unilateral location, pulsating quality, moderate/severe pain and either nausea/vomiting or photophobia and phonophobia) and migraine with aura (reversible focal neurological symptoms that develop over 5-20 minutes and last for less than 60 minutes); average at given month was calculated by dividing total number of migraine attack days until that month by the total number of days of assessment, multiplied by 28 (a month was equal to 28 days).|Baseline (28 days before randomization), Month 1, 2, 3, 4, 5 and 6|The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization.||Days||Standard Deviation|Mean
814558|NCT01081795|Primary|Mean Change From Baseline in Monthly Migraine Attacks (According to 24-Hour Rule) Through Month 6|As per 24-hour rule, if symptom of pain due to migraine continues for more than 24 hours, it should be considered as 2 or more migraine attacks considering the maximum duration up to 24 hours. If the interval between latest migraine attack (ending time) and previous migraine attack (onset time) is less than 24 hours, 2 migraine attacks should be considered as 1 migraine attack. If the onset of migraine was prevented by a rescue drug, it should be considered as 1 migraine attack even if aura had started. Mean change was calculated by subtracting baseline value from the mean of 6 months value.|Baseline (28 days before randomization) through Month 6|Full analysis set (FAS) included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization.||Migraine attacks||Standard Deviation|Mean
814559|NCT01081834|Secondary|Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26 (High Glycemic Substudy)|The table below shows the least-squares mean percent change in HDL-C from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values||Percent change||Standard Error|Least Squares Mean
814560|NCT01081834|Secondary|Percent Change in Triglycerides From Baseline to Week 26 (High Glycemic Substudy)|The table below shows the least-squares mean percent change in triglycerides from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percent change||Standard Error|Least Squares Mean
814561|NCT01081834|Secondary|Change in Systolic Blood Pressure (SBP) From Baseline to Week 26 (High Glycemic Substudy)|The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values||mmHg||Standard Error|Least Squares Mean
814562|NCT01081834|Secondary|Percent Change in Body Weight From Baseline to Week 26 (High Glycemic Substudy)|The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values||Percent change||Standard Error|Least Squares Mean
814563|NCT01081834|Secondary|Change in 2-hour Post-prandial Glucose From Baseline to Week 26 (High Glycemic Substudy)|The table below shows the least-squares (LS) mean change in 2-hour post-prandial glucose from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values||mg/dL||Standard Error|Least Squares Mean
814564|NCT01081834|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 (High Glycemic Substudy)|The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values||mg/dL||Standard Error|Least Squares Mean
814565|NCT01081834|Secondary|Percentage of Patients With HbA1c <7% at Week 26 (High Glycemic Substudy)|The table below shows the percentage of patients with HbA1c <7% at Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.|Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values||Percentage of patients|||Number
814566|NCT01081834|Secondary|Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26 (Main Study)|The table below shows the least-squares (LS) mean percent change in HDL-C from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values||Percent change||Standard Error|Least Squares Mean
814567|NCT01081834|Secondary|Percent Change in Triglycerides From Baseline to Week 26 (Main Study)|The table below shows the least-squares (LS) mean percent change in triglycerides from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values||Percent change||Standard Error|Least Squares Mean
814568|NCT01081834|Secondary|Change in Systolic Blood Pressure (SBP) From Baseline to Week 26 (Main Study)|The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values||mmHg||Standard Error|Least Squares Mean
814569|NCT01081834|Secondary|Percent Change in Body Weight From Baseline to Week 26 (Main Study)|The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values||Percent change||Standard Error|Least Squares Mean
814570|NCT01081834|Secondary|Change in 2-hour Post-prandial Glucose From Baseline to Week 26 (Main Study)|The table below shows the least-squares (LS) mean change in 2-hour post-prandial glucose from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values||mg/dL||Standard Error|Least Squares Mean
814571|NCT01081834|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 (Main Study)|The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values||mg/dL||Standard Error|Least Squares Mean
814572|NCT01081834|Secondary|Percentage of Patients With HbA1c <7% at Week 26 (Main Study)|The table below shows the percentage of patients with HbA1c <7% at Week 26. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage.|Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values||Percentage of patients|||Number
814573|NCT01081834|Primary|Change in HbA1c From Baseline to Week 26 (High Glycemic Substudy)|The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values||Percent||Standard Error|Least Squares Mean
816299|NCT01107418|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC[0-24h]) of Vemurafenib on Day 1||Pre-dose, 1, 2, 4, 5, 8, 24 hours post-dose on Day 1|PK population. Here, number of participants analyzed signifies participants evaluable for this outcome.||mcg*h/mL||Standard Deviation|Mean
814574|NCT01081834|Primary|Change in HbA1c From Baseline to Week 26 (Main Study)|The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values||Percent||Standard Error|Least Squares Mean
814575|NCT01088984|Secondary|Area Under the Plasma Drug Concentration by Time Curve From Time 0 Until 24 Hours After Study Drug Administration (AUC0-24) for Bendamustine and Its Metabolites (M3 and M4)||Cycle 1, Day 1: before infusion, immediately following the infusion, and 3, 6, 10(±2), and 24 hours after the start of infusion. The 24-hour postinfusion sample was obtained before the start of the infusion on Day 2.|The pharmacokinetic analysis set included all participants who were in the safety analysis set (ie, those treated at any dose of bendamustine) who had valid pharmacokinetic data; n=number of participants with valid data for this assessment.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
814576|NCT01088984|Secondary|Area Under the Plasma Drug Concentration by Time Curve From Time 0 Until the Last Measurable Plasma Concentration (AUC0-t) for Bendamustine and Its Metabolites (M3 and M4)||Cycle 1, Day 1: before infusion, immediately following the infusion, and 3, 6, 10(±2), and 24 hours after the start of infusion. The 24-hour postinfusion sample was obtained before the start of the infusion on Day 2.|The pharmacokinetic analysis set included all participants who were in the safety analysis set (ie, those treated at any dose of bendamustine) who had valid pharmacokinetic data; n=number of participants with valid data for this assessment.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
814577|NCT01088984|Secondary|Time to Maximum Plasma Drug Concentration (Tmax) for Bendamustine and Its Metabolites (M3 and M4)||Cycle 1, Day 1: before infusion, immediately following the infusion, and 3, 6, 10(±2), and 24 hours after the start of infusion. The 24-hour postinfusion sample was obtained before the start of the infusion on Day 2.|The pharmacokinetic analysis set included all participants who were in the safety analysis set (ie, those treated at any dose of bendamustine) who had valid pharmacokinetic data; n=number of participants with valid data for this assessment.||hours||Geometric Coefficient of Variation|Geometric Mean
814578|NCT01088984|Secondary|Maximum Observed Plasma Drug Concentration (Cmax) for Bendamustine and Its Metabolites (M3 and M4)||Cycle 1, Day 1: before infusion, immediately following the infusion, and 3, 6, 10(±2), and 24 hours after the start of infusion. The 24-hour postinfusion sample was obtained before the start of the infusion on Day 2.|The pharmacokinetic analysis set included all participants who were in the safety analysis set (ie, those treated at any dose of bendamustine) who had valid pharmacokinetic data; n=number of participants with valid data for this assessment.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
814579|NCT01088984|Secondary|Duration of Response (DOR)|DOR was determined for the participants with CR or CRp in the primary analysis set, defined as the time from first achieving remission to the time when progression was diagnosed, the participant died, or the participant started receiving new antineoplastic therapy. Data from participants who do not progress were censored at the last valid assessments. Median DOR and its 95% confidence interval was determined based on the Kaplan-Meier method. Data from participants who received a transplant were censored at the time of the transplant.|At each treatment cycle (21 to 35 days), for a maximum of 12 cycles|No duration of remission (defined as CR or CRp) analysis was performed for participants in the primary analysis since none achieved remission.|||||
814580|NCT01088984|Secondary|Best Overall Tumor Response Rate, by Phase|Biological activity of bendamustine was defined as achieving a best response of partial response (PR), CRp, or CR. Rate was calculated as follows: number of participants in the primary analysis set achieving a best overall response of PR, CRp, or CR, divided by the number of participants in the primary analysis set. The most positive response for each patient during the study was counted. The 95% CI was calculated using binomial parameter exact method. Response was determined by the investigator, and evaluated per Jeha et al, 2006: A PR had to meet the following criteria: complete disappearance of circulating blasts and an M2 marrow (≥ 5% and ≤ 25% bone marrow blasts) and appearance of normal progenitor cells or an M1 marrow that did not qualify for CR or CRp. See Outcome Measure 2 for full definitions for CRp and CR.|At each treatment cycle (21 to 35 days), for a maximum of 12 cycles|The safety analysis set included all participants treated at any dose of bendamustine.||percentage of participants||95% Confidence Interval|Number
814581|NCT01088984|Secondary|Best Overall Tumor Response Rate|Biological activity of bendamustine was defined as achieving a best response of partial response (PR), CRp, or CR. Rate was calculated as follows: number of participants in the primary analysis set achieving a best overall response of PR, CRp, or CR, divided by the number of participants in the primary analysis set. The most positive response for each patient during the study was counted. The 95% CI was calculated using binomial parameter exact method. Response was determined by the investigator, and evaluated per Jeha et al, 2006: A PR had to meet the following criteria: complete disappearance of circulating blasts and an M2 marrow (≥ 5% and ≤ 25% bone marrow blasts) and appearance of normal progenitor cells or an M1 marrow that did not qualify for CR or CRp. See Outcome Measure 2 for full definitions for CRp and CR.|At each treatment cycle (21 to 35 days), for a maximum of 12 cycles|The primary analysis set for efficacy included all participants treated at the RP2D in Phase 2.||percentage of participants||95% Confidence Interval|Number
814582|NCT01088984|Primary|Overall Response Rate (ORR)|ORR was calculated as follows: number of participants in the primary analysis set achieving a best overall response of complete remission without platelet recovery (CRp) or complete remission (CR), divided by the number of participants in the primary analysis set. The most positive response for each patient during the study was counted. The 95% CI was calculated using binomial parameter exact method. Response was determined by the investigator, and evaluated per Jeha et al, 2006: A CR required no evidence of circulating blasts or extramedullary disease, an M1 marrow (≤ 5% bone marrow blasts), and recovery of peripheral counts (platelets ≥ 100 × 10^9/L and absolute neutrophil count ≥ 1.0 × 10^9/L). A CR without platelet recovery (CRp) required all of the criteria for a CR with the exception of platelet recovery.|Assessed at each treatment cycle (21 to 35 days), for a maximum of 12 cycles|The primary analysis set for efficacy included all participants treated at the RP2D in Phase 2.||percentage of participants||95% Confidence Interval|Number
814583|NCT01088984|Primary|Recommended Phase II Dose (RP2D) of Bendamustine|RP2D was determined by a traditional 3+3 dose escalation design, with the following restrictions: only doses of 60, 90, 120, and 150 mg/m^2 were explored, and escalation to 150 mg/m^2 would only occur if the 120 mg/m^2 dose was deemed safe and pharmacokinetic data indicate subtherapeutic exposure as compared with adults. The first cohort was administered bendamustine at the 90 mg/m^2 dose; de-escalation to the 60 mg/m^2 dose would only occur if the starting dose led to dose-limiting toxicity (DLT) in 2 or more participants. A DLT was defined as any study drug-related nonhematologic adverse event (AE) that was grade 4 for toxicity by National Cancer Institute's Common Toxicity Criteria for AEs, version 4. In addition, grade 3 or above allergic reaction or skin rash were considered DLTs. Hematologic AEs were not considered DLTs. The dose level at which at least 2 of 3 or 2 of 6 participants had a DLT was considered as exceeding the RP2D. The RP2D was the dose 1 step below that level.|Induction Cycle (21- to 35-day cycle)|All participants enrolled in Phase 1 of the study.||mg/m^2|||Number
814584|NCT01088997|Secondary|Change in Myocardial Performance Index (MPI) From Baseline to up to 24 Hours After Start of Milrinone Infusion|An echocardiogram obtained while on milrinone was obtained with the goal of attempting to look for improvements in parameters associated with pulmonary hypertension. The primary parameter measured was the myocardial performance index (MPI). An Echocardiogram was performed at baseline (pre-infusion) and repeated 12-24 hours ater the initiation of the Milrinone infusion. Also known as the Tei index, the MPI is an index that incorporates both systolic and diastolic time intervals in expressing global systolic and diastolic ventricular function. Systolic dysfunction prolongs preejection (isovolumic contraction time, IVCT) and a shortening of the ejection time (ET). Both systolic and diastolic dysfunction result in abnormality in myocardial relaxation which prolongs the relaxation period (isovolumic relaxation time, IVRT). Normal value for MPI is 0.39+/-0.05 with dilated cardiomyopathy value of MPI at 0.59+/-0.10 (both units on a scale)|Up to 24 hours after start of infusion|||units on a scale||Standard Deviation|Mean
814585|NCT01088997|Primary|Define Plasma Concentration-time Profile of Milrinone in Neonates With Persistent Pulmonary Hypertension of the Newborn (PPHN) - Clearance (CL, mL/Min)|The schedule of milrinone pharmacokinetic (PK) sampling varied by weight to minimize blood sampling. For babies weighing less than 3kg, samples were drawn at the end of the bolus, 15 minutes prior to the end of infusion (EOI) and 20 minutes, 1, 2, 6 and 12 hours after EOI. For babies weighing 3kg or more, samples were drawn at the end of the bolus, 6 hours after start of infusion, 15 minutes prior to the EOI and 30 minutes, 1, 3, 9 and 15 hours after EOI. Milrinone plasma concentrations were determined using a validated high-performance mass spectrometry assay.|End of bolus dose, 15 minutes prior to end of infusion (EOI), at four time points after EOI with final sample at 12-15 hours after EOI (timing based on infant's weight)|The pharmacokinetic analysis, including the primary outcome parameter, Clearance, was planned a priori to include all the participants pooled together. A PK analysis by arm wouldn't be appropriate. The randomization arms were only created to explore the secondary clinical and pharmacodynamic outcomes.||mL/min/3.4 kg||Standard Error|Mean
814586|NCT01088997|Secondary|Change in Oxygenation Index (OI) From Baseline to up to 24 Hours After Start of Milrinone Infusion|Oxygenation Index (mean airway pressure*Fraction of Inspired Oxygen/Partial Pressure of Oxygen in the blood) was calculated at baseline and every 6 hours after start of infusion until 12-24 hours after initiation of milrinone infusion.|for up to 24 hours after start of infusion|OI was calculated every 6 hours after start of infusion for 24 hours.||units on a scale||Standard Deviation|Mean
814587|NCT01089023|Secondary|Erythrocyte Sedimentation Rate|ESR (measured in mm/hr) is an inflammation marker used to determine acute phase response.|Baseline and Weeks 4, 8, 12, 16, 20, and 24|All the participants who were administered treatment at each visit were considered during the analysis.||mm/hr||Standard Deviation|Mean
814588|NCT01089023|Secondary|C-Reactive Protein (CRP) Values by Study Visit|CRP is an acute phase inflammatory marker. The serum concentration of CRP is measured in milligrams per liter (mg/L). A reduction in the level is considered an improvement.|Baseline and Weeks 4, 8, 12, 16, 20, and 24|All the participants who were administered treatment at each visit were considered during the analysis.||mg/L||Standard Deviation|Mean
814589|NCT01089023|Secondary|HAQ-DI Score by Visit|HAQ includes 20 questions concerning participant’s activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant’s everyday activities: 0=without difficulties; 1= with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3..|Baseline and Weeks 4, 8, 12, 16, 20, and 24|"All the participants who were administered treatment at each visit were considered during the analysis.
n at Week 24 = number of participants in that visit; n at Other Visits = number of participants with treatment administered"||scores on a scale||Standard Deviation|Mean
814590|NCT01089023|Secondary|Percentage of Participants With Improvement in Physical Function by HAQ-DI Category|Physical function scoring was as follows with respect to performance of participant’s everyday activities: 0=without difficulties; 1= with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3. The HAQ-DI score at every visit was categorized into none to mild disability (HAQ-DI <1), moderate disability (1≤ HAQ-DI <2) and severe disability (HAQ-DI ≥2). The percentages of the participants falling in each of these categories with respect to the visits were determined.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|"All the participants who were administered treatment at each visit were considered during the analysis.
n at Week 24 = number of participants in that visit; n at Other Visits = number of participants with treatment administered"||percentage of participants|||Number
814591|NCT01089023|Secondary|Percentage of Participants With a Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) of at Least 0.22 Units|HAQ includes 20 questions concerning participant’s activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant’s everyday activities: 0=without difficulties; 1= with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3.|Weeks 4, 8, 12, 16, 20, and 24|"All the participants who were administered treatment at each visit were considered during the analysis.
n at Week 24 = number of participants in that visit; n at Other Visits = number of participants with treatment administered"||percentage of participants|||Number
814593|NCT01089023|Secondary|Percentage of Participants Achieving a Clinically Meaningful Improvement as Measured by DAS28|DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hr) and global health assessment (participant rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. Participants achieved a clinically meaningful improvement in DAS28 if there was a reduction of at least 1.2 units from baseline.|Weeks 4, 8, 12, 16, 20, and 24|"All the participants who were administered treatment at each visit were considered during the analysis.
n at Week 24 = number of participants in that visit; n at Other Visits = number of participants with treatment administered"||percentage of participants|||Number
814594|NCT01089023|Secondary|Percentage of Participants by Disease Activity Score Based on 28-Joint Count (DAS28) Category|DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and global health assessment (participant rated global assessment of disease activity using 10-mm Visual analog scale - VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. A DAS28 score of greater than (>)5.1 indicated high disease activity, a score of >3.2 but less than or equal to (≤)5.1 indicated moderate disease activity, a score of greater than or equal to (≥)2.6 but ≤3.2 indicated low disease activity, and a score of less than <2.6 indicated disease remission. Week 24 is the Follow-Up visit.|Baseline and Weeks 4, 8, 12, 16, 20, and 24|"All the participants who were administered treatment at each visit were considered during the analysis.
n (number) at Week 24 equals (=) number of participants in that visit; n at Other Visits = number of participants with treatment administered"||percentage of participants|||Number
814595|NCT01089023|Primary|Percentage of Participants Reporting Any Adverse Event - Overall Summary of Events|Percentage of participants with a serious adverse event (SAE), who died, with an adverse event (AE), or study drug related AE during the study.|Baseline and Weeks 2, 4, 8, 12, 16, 20, and 24|All the participants who were administered treatment at each visit were considered during the analysis.||percentage of participants|||Number
814596|NCT01089062|Secondary|Change From Baseline in QTc Interval at 14 Minutes After the 1st and 2nd Dose|The corrected QT interval (QTc) is a measurement of the electrical impulses through the largest part of the heart muscle. A negative change is a shortening of the QTc interval, a positive change is a lengthening of the QTc interval.|baseline, 14 minutes from time of 1st dose, 14 minutes from time of 2nd dose|Patients with available data at the required time point were included in the analysis population.||milliseconds||Standard Deviation|Mean
814597|NCT01089062|Secondary|Change in Blood Pressure From Baseline After the Two 2-hour Post Dosing Periods|Systolic and diastolic blood pressure measure the lowest and highest pressures against the walls of the arteries. Changes were calculated from 30 minutes pre dose (baseline) to 10 minutes post first and second dose. A positive change from baseline indicates an increase in blood pressure and a negative change indicates a decrease in blood pressure.|baseline, 10 minutes post 1st dose, 10 minutes post 2nd dose|Patients with available data at the required time point were included in the analysis population.||mmHg||Standard Deviation|Mean
814598|NCT01089062|Secondary|AUC(0-4hrs) of Pulmonary Arterial Systolic Pressure (PASP) From the Start of the First Dose to Two Hours After the Second Dose|AUC(0-4hrs) (Area Under the Curve, time 0-4 hours post-1st dose) in PASP millimeters of mercury times minutes (mmHg*min). PASP is the highest pressure exerted on the walls of the pulmonary artery.|4 hours from the time of first dose|Patients with available data at the required time point were included in the analysis population.||mmHg*min||Standard Deviation|Mean
814599|NCT01089062|Secondary|Maximum Change in PASP From Baseline to the Two Hour Period Following the First Dose|Pulmonary artery systolic pressure (PASP) is the highest pressure exerted on the walls of the pulmonary artery.|baseline and 2 hours from the time of first dose|Patients with available data at the required time point were included in the analysis population.||mmHg||Standard Deviation|Mean
814600|NCT01089062|Secondary|Percent of Subjects With an Increase in PASP Greater Than 10mmHg From Baseline to 2 Hours From the First Dose|Pulmonary artery systolic pressure (PASP) is the highest pressure exerted on the walls of the pulmonary artery.|baseline and 2 hours from the time of first dose|Patients with available data at the required time point were included in the analysis population.||percentage of participants|||Number
814601|NCT01089062|Primary|AUC(0-2hrs) of Pulmonary Arterial Systolic Pressure (PASP) Over Time Post 1st Dose|AUC(0-2hrs) (Area Under the Curve, time 0-2 hours post-1st dose) in PASP millimeters of mercury times minutes (mmHg*min). PASP is the highest pressure exerted on the walls of the pulmonary artery.|2 hours from time of first dose|Patients with available data at the required time point were included in the analysis population.||mmHg*min||Standard Deviation|Mean
814602|NCT01089127|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose on Day 2|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose on Day 2. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|24 hours post-dose on Day 2|Full analysis set: All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).||Liters||Standard Error|Least Squares Mean
814603|NCT01089127|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of the Study (Week 2 + 1 Day, Day 15)|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|24 hours post-dose at the end of the study (Week 2 + 1 day, Day 15)|Full analysis set: All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).||Liters||Standard Error|Least Squares Mean
814604|NCT01090011|Secondary|Progression-Free Survival (PFS) Time|Progression-Free Survival was defined as the duration of time from start of treatment until the day of objective tumour progression confirmed by tumour imaging (PD according to RECIST 1.1) or death.|up to 116 weeks|Treated set. 32 patients in the Afa40-mono group had disease progression and were transitioned to treatment with Afa40+Ctx500. Thus the total of 203 patients (4+126+37+36) minus the 32 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.||months||95% Confidence Interval|Median
814605|NCT01090011|Secondary|Duration of Disease Control (According to RECIST v1.1)|Duration of disease control was defined as the time from the start of treatment to the time of progression or death (whichever occurred first), among patients with evidence SD, PR or CR.|up to 116 weeks|Treated set. 32 patients in the Afa40-mono group had disease progression and were transitioned to treatment with Afa40+Ctx500. Thus the total of 203 patients (4+126+37+36) minus the 32 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.||months||Standard Deviation|Mean
814606|NCT01090011|Secondary|Duration of Objective Response (According to RECIST v1.1)|Duration of objective response was measured from the time measurements criteria were met for CR/PR (whichever was first recorded) until the first date that recurrent or PD was objectively documented (taking as reference for PD the smallest measurements recorded since treatment started).|up to 116 weeks|Treated set. 32 patients in the Afa40-mono group had disease progression and were transitioned to treatment with Afa40+Ctx500. Thus the total of 203 patients (4+126+37+36) minus the 32 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.||months||Standard Deviation|Mean
814607|NCT01090011|Secondary|Objective Tumor Response (Complete Response [CR] and Partial Response [PR]) Determined by RECIST v1.1)|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD), At least a 20% increase in the sum of the longest diameter of target lesions or the appearance of new lesion(s); Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Objective tumor response = CR + PR."|up to 116 weeks|Treated set. 32 patients in the Afa40-mono group had disease progression and were transitioned to treatment with Afa40+Ctx500. Thus the total of 203 patients (4+126+37+36) minus the 32 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.||percentage of patients|||Number
814608|NCT01090011|Secondary|Disease Control (CR, PR and Stable Disease (SD) Determined by RECIST v1.1)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD), At least a 20% increase in the sum of the longest diameter of target lesions or the appearance of new lesion(s); Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Disease control = CR + PR + SD.|up to 116 weeks|Treated set. 32 patients in the Afa40-mono group had disease progression and were transitioned to treatment with Afa40+Ctx500. Thus the total of 203 patients (4+126+37+36) minus the 32 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.||percentage of patients||95% Confidence Interval|Number
814609|NCT01090011|Secondary|Predose Plasma Concentrations of Afatinib for the Combination Arm|Predose plasma concentrations (Cpre,ss) of Afatinib at Course 1, Visit 2, 3, 4 and 5, at Course 2, Visit 1 and 2 and at Course 3, Visit 1.|Up to 57 days|Pharmacokinetic dataset (PKS)||ng/mL||Geometric Coefficient of Variation|Geometric Mean
814610|NCT01090011|Secondary|Vz/F,ss|Apparent volume of distribution during the terminal phase λz at steady state following extravascular administration (Vz/F,ss) for 15 days|Course 1, Visit 3 and 4, Day 15 and 16, Hours: -0:05,0,1,2,3,4,5,6,8, and 23:55|Pharmacokinetic dataset (PKS)||L||Geometric Coefficient of Variation|Geometric Mean
814611|NCT01090011|Secondary|CL/F,ss,15|Apparent clearance of afatinib in plasma at steady state after extravascular multiple dose administration (CL/F,ss)|Course 1, Visit 3 and 4, Day 15 and 16, Hours: -0:05,0,1,2,3,4,5,6,8, and 23:55|Pharmacokinetic dataset (PKS)||mL/min||Geometric Coefficient of Variation|Geometric Mean
814612|NCT01090011|Secondary|MRTpo,ss|mean residence time of Afatinib in the body at steady state after oral administration (MRTpo,ss) for 15 days|Course 1, Visit 3 and 4, Day 15 and 16, Hours: -0:05,0,1,2,3,4,5,6,8, and 23:55|Pharmacokinetic dataset (PKS)||h||Geometric Coefficient of Variation|Geometric Mean
814613|NCT01090011|Secondary|t1/2,ss|Terminal half-life of Afatinib in plasma at steady state (t1/2,ss)|Course 1, Visit 3 and 4, Day 15 and 16, Hours: -0:05,0,1,2,3,4,5,6,8, and 23:55|Pharmacokinetic dataset (PKS)||h||Geometric Coefficient of Variation|Geometric Mean
814614|NCT01090011|Secondary|Peak-trough Fluctuation (PTF)|Peak-trough fluctuation (PTF) of plasma afatinib for the combination arm. PTF = 100*(Cmax-Cmin)/Caverage where Caverage = AUC/time, where time equals 24 hours.|Course 1, Visit 3 and 4, Day 15 and 16, Hours: -0:05,0,1,2,3,4,5,6,8, and 23:55|Pharmacokinetic dataset (PKS)||% of average concentration||Geometric Coefficient of Variation|Geometric Mean
814615|NCT01090011|Secondary|Concentration of Afatinib in Plasma for the Combination Arm|Minimum measured concentration of Afatinib in plasma at steady state over 15 day dosing interval (Cmin,ss). Maximum measured concentration of Afatinib in plasma at steady state over 15 day dosing interval (Cmax,ss).|Course 1, Visit 3 and 4, Day 15 and 16, Hours: -0:05,0,1,2,3,4,5,6,8, and 23:55|Pharmacokinetic dataset (PKS)||ng/mL||Geometric Coefficient of Variation|Geometric Mean
814616|NCT01090011|Secondary|Area Under the Concentration-time Curve (AUC) on Day 15 of Plasma Afatinib for the Combination Arm|Area Under the Concentration-time Curve (AUC) of Afatinib in plasma at steady state over a uniform dosing interval tau (15 days) (AUCtau,ss) after oral administration of Afatinib and cetuximab combination therapy|Course 1, Visit 3 and 4, Day 15 and 16, Hours: -0:05,0,1,2,3,4,5,6,8, and 23:55|Pharmacokinetic dataset (PKS)||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
814617|NCT01090011|Secondary|Frequency (%) of Patients With Related Serious Adverse Events|Frequency (%) of patients with drug-related serious adverse events|From first drug administration to 28 days after discontinuation of drug intake up to 915 days|Treated set. 32 patients in the Afa40-mono group had disease progression and were transitioned to treatment with Afa40+Ctx500. Thus the total of 203 patients (4+126+37+36) minus the 32 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.||percentage of patients|||Number
814618|NCT01090011|Secondary|Frequency (%) of Patients With Adverse Events Leading to Death||From first drug administration to 28 days after discontinuation of drug intake up to 915 days|Treated set. 32 patients in the Afa40-mono group had disease progression and were transitioned to treatment with Afa40+Ctx500. Thus the total of 203 patients (4+126+37+36) minus the 32 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.||percentage of patients|||Number
814619|NCT01090011|Secondary|Frequency (%) of Patients With Adverse Events Leading to Treatment Discontinuation|Frequency (%) of patients with adverse events leading to treatment discontinuation|From first drug administration to 28 days after discontinuation of drug intake up to 915 days|Treated set. 32 patients in the Afa40-mono group had disease progression and were transitioned to treatment with Afa40+Ctx500. Thus the total of 203 patients (4+126+37+36) minus the 32 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.||percentage of patients|||Number
814620|NCT01090011|Secondary|Frequency (%) of Patients With Adverse Events Leading to Dose Reduction||From first drug administration to 28 days after discontinuation of drug intake up to 915 days|Treated set. 32 patients in the Afa40-mono group had disease progression and were transitioned to treatment with Afa40+Ctx500. Thus the total of 203 patients (4+126+37+36) minus the 32 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.||percentage of patients|||Number
814621|NCT01090011|Secondary|Frequency of Patients [N(%)] With Possible Clinically Significant Abnormalities for Selected Laboratory Parameters||From first drug administration to 28 days after discontinuation of drug intake up to 915 days|Treated set. 32 patients in the Afa40-mono group had disease progression and were transitioned to treatment with Afa40+Ctx500. Thus the total of 203 patients (4+126+37+36) minus the 32 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.||percentage of patients|||Number
814622|NCT01090011|Secondary|Highest CTCAE Grade|Safety of afatinib when administered together with cetuximab as indicated by intensity and incidence of adverse events, graded according to the U.S. National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) Version (v) 3.0|From first drug administration to 28 days after discontinuation of drug intake up to 915 days|Treated set. 32 patients in the Afa40-mono group had disease progression and were transitioned to treatment with Afa40+Ctx500. Thus the total of 203 patients (4+126+37+36) minus the 32 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.||percentage of patients|||Number
814623|NCT01090011|Primary|The Primary Endpoint is the Occurrence of Dose Limiting Toxicity (DLT).|"A DLT was defined as an AE or laboratory abnormality that a) related to the study regimen; b) or met any of the following criteria:
CTCAE Grade 2 or higher decrease in cardiac left ventricular function
CTCAE Grade 2 diarrhea lasting for 7 or more days, despite appropriate use of standard anti-diarrheal therapy
CTCAE Grade ≥3 diarrhea despite appropriate use of standard anti-diarrheal therapy for at least 2 days
CTCAE Grade ≥3 nausea and/or vomiting despite appropriate use of standard anti-emetics for at least 3 days
CTCAE Grade ≥3 rash despite standard medical management
CTCAE Grade ≥3 fatigue lasting for more than 7 days
CTCAE Grade 4 hypomagnesaemia or Grade 3 hypomagnesaemia with clinical significant sequelae
All other toxicities of CTCAE Grade ≥3 (except alopecia, and allergic reaction) leading to an interruption of afatinib and/or cetuximab for more than 14 days until recovery to baseline or Grade 1, whichever was higher."|from day 1 treatment until progression or undue toxicity, up to 28 days|Treated set for Cohort One. Cohort one was based on the data from the first treatment cycle where four patients received 'Afatinib 40+Cetuximab 250' and six patients received 'Afatinib 40+Cetuximab 500'.||participants|||Number
814624|NCT01090050|Secondary|Compliance With Lifestyle Changes|Self-assessed grade of compliance with lifestyle modification changes (where A=1, B=2, C=3, D=4, and F=5) in the Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. Lower scores indicate a better outcome. Higher scores indicate a worse outcome.|Day 121|||Units on a scale||Standard Deviation|Mean
814625|NCT01090050|Secondary|Migraine Disability Assessment(MIDAS)Questionnaire Total Score|"Change in Migraine Disability Assessment (MIDAS) total score (effect migraine headaches have on subjects daily function) from Baseline (Day 31) to 3 months after Baseline to end of Treatment Period Month 3(Day 121) following final dose of study medication in the Sumatriptan/Naproxen Sodium arm vs. the Naproxen Sodium arm.
Total score of disability ranges:
0 to 5, MIDAS Grade I, Little or no disability
6 to 10, MIDAS Grade II, Mild disability
11 to 20, MIDAS Grade III, Moderate disability
21+, MIDAS Grade IV, Severe disability Score ranges from 0-450. No subscales are present."|Baseline MIDAS collected at Day 31, Post final dose study at Day 121.|||scores on a scale||Standard Deviation|Mean
814626|NCT01090050|Secondary|Percent Change of Doses of Study Medication|"Comparing the number of doses of study medication taken during Baseline Period(days 1-30) of triptans(Group A) and non-steroidal anti-inflammatory drugs(NSAIDS)(Group B)to the number of doses of study medication taken during Treatment Period Months 1(days 31-60), 2(days 61-90), and 3(days 91-120)in the Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm.
e.g.Percent change=[(number of doses of study medication during Treatment Period Month 3(days 91-120)-number of doses of study medication during Baseline(days 1-30)/number of doses of study medication during Baseline(days 1-30)]*100%)."|Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 92, and 121 respectively.|||percent doses of study medication||Standard Deviation|Mean
814627|NCT01090050|Secondary|Migraine Headache Days With Greater Than 50% Reduction|Number of subjects with at least 50% reduction in number of migraine headache days reported in Baseline vs. Treatment Period months 1(days 31-60), 2(days 61-90), and 3(days 91-120)in the Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm.|Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 92, and 121 respectively.|||participants|||Number
814628|NCT01090050|Secondary|Migraine Headache Duration From Time of Treatment to Pain Free|"Comparing mean migraine duration from time of treatment to pain free from Baseline Period (Days 1-30), to each of the Treatment Period Months 1(days 31-60), 2(days 61-90), and 3(days 91-120) in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. Percent change was calculated by determining percent change in each subject, from each Treatment Period month compared to Baseline. The following formula was used for each treatment period month calculation.
e.g. Percent change=[(mean migraine duration from time of treatment to pain free during Treatment Period Month 3(days 91-120)-mean migraine duration from time of treatment to pain free during Baseline(days 1-30)/mean duration from time of treatment to pain free during Baseline(days 1-30)]*100%)"|Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121 respectively.|||percent hours of migraine duration||Standard Deviation|Mean
816894|NCT01116232|Primary|Incidence and Severity of Acute Graft-vs-host Disease (GVHD)||During the first six months post transplant|Study terminated due to lack of funding. No analysis, patient data on this protocol due to the fact that only four patients was able to be accrued.|||||
814629|NCT01090050|Secondary|Migraine Headache Duration From Onset to Pain Free|"Comparing mean migraine duration from onset to pain free from Baseline Period (Days 1-30), to each of the Treatment Period Months 1(days 31-60), 2(days 61-90), and 3(days 91-120) in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. Percent change was calculated by determining percent change in each subject, from each Treatment Period month compared to Baseline. The following formula was used for each treatment period month calculation.
e.g. Percent change=[(mean migraine duration from onset to pain free during Treatment Period Month 3(days 91-120)-mean migraine duration from onset to pain free during Baseline(days 1-30)/mean duration from onset to pain free during Baseline(days 1-30)]*100%)"|Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121 respectively.|||percent hours of migraine duration||Standard Deviation|Mean
814630|NCT01090050|Secondary|Percent Change of Migraine Headache Days in All Treatment Periods Compared to Baseline|"Comparing number of migraine headache days from Baseline to Treatment Period Months 1, 2, and 3 in the Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm.
Comparing the number of migraine headache days reported from Baseline Period days 1-30 to number of migraine headache days reported in Treatment Period days Months 1(days 31-60), 2(days 61-90),and 3(days 91-120)in the Sumatriptan/Naproxen Sodium arm versus (vs.) Naproxen Sodium arm. Each treatment period month percent change was individually compared to Baseline. The following formula was used for each treatment period calculation.
e.g. percent change=[(total headache days during Treatment Period Month 3(days 91-120)-total headache days during Baseline(days 1-30)/total headache days during Baseline(days 1-30)]*100%)"|Baseline Period (days 1-30) collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121, respectively.|||percent migraine headache days per month||Standard Deviation|Mean
814631|NCT01090050|Primary|Percent Change of Migraine Headache Days Compared to Baseline|Comparing the number of migraine headache days during Baseline Period days 1-30 to number of migraine headache days reported in Treatment Period days 91-120 in the Sumatriptan/Naproxen Sodium arm versus (vs.) Naproxen Sodium arm. Percent change=[(total headache days during Treatment Period Month 3(days 91-120)-total headache days during Baseline(days 1-30)/total headache days during Baseline(days 1-30)]*100%)|Day 121 (following 30 day Baseline Period and Treatment Period days 91-120.|||percent migraine headache days per month||Standard Deviation|Mean
814632|NCT01090063|Secondary|Safety Outcome Measures|All adverse events (AE's) will be recorded and monitored. At each of the study visits, patients will be questioned about the occurrence of new AE's since the last visit, or the outcome of any AE's that were reported at previous visits. Upon study completion of the first 10 subjects the principal investigator will review all adverse events to check for trends.|24 weeks|All participants who enrolled. Participants terminating prior to week 24 had their data carried forward as lost to follow-up.||participants|||Number
814633|NCT01090063|Secondary|Pain Visual Analog Scale From Baseline to Week 24|"Patient's score on the questionnaire of how much pain are you experiencing from your disease of your hands and feet, as measured in mm from the left end of scale. Maximum score is 100, minimum score is 0. Visual Analog Scale (VAS). 100 indicates maximum pain (worse outcome), 0 indicates minimum pain (better outcome)."|Baseline, 24 weeks|All participants who enrolled. Early terminations were carried as last observation carried forward.||units on a scale||Standard Deviation|Mean
814634|NCT01090063|Secondary|Pruritus Visual Analog Scale From Baseline to Week 24|"Patient's score on the questionnaire of how itchy are you, as measured in mm from the left end of scale. Maximum score is 100, minimum score is 0. 100 indicates maximum itch (worse outcome), 0 indicates minimum itch (better outcome)."|Baseline, 24 weeks|All participants who enrolled. Early terminations were carried as last observation carried forward.||units on a scale||Standard Deviation|Mean
814635|NCT01090063|Secondary|Fissure Count (if Present at Baseline) From Baseline to Week 24|Number of discrete fissures on the hands and feet of each subject.|Baseline, 24 weeks|All participants who enrolled. Early terminations were carried as last observation carried forward.||fissures||Standard Deviation|Mean
814636|NCT01090063|Secondary|Pustule Count (if Present at Baseline) From Baseline to Week 24|Number of pustules present in each subject|Baseline, 24 weeks|All participants who enrolled. Early terminations were carried as last observation carried forward.||pustules||Standard Deviation|Mean
814637|NCT01090063|Secondary|PGA Score Over Time From Baseline to Week 24|Measurement of subject's palmar and plantar psoriasis severity as measured by the Physician's Global Assessment (PGA) scale, which rates the severity of psoriasis using the measures of erythema, scaling and induration. Scores are from 0 to 4, in 1 unit increments. A score of 4 is very severe, and a score of 0 is clear.|Baseline, 24 weeks|All participants who enrolled. Early terminations were carried as last observation carried forward.||units on a scale||Full Range|Median
814638|NCT01090063|Primary|Percentage of Patients Achieving a Palmar/Plantar PGA Score of 0 or 1 at Week 16.||16 weeks|Number of participants completing enrollment. Lost values carried forward as last observation carried forward||percentage of participants|||Number
814639|NCT01090076|Primary|% Wound Area Week 2|Percentage change in wound area after week 2|Weeks 1 to 2|||Percentage change||Standard Error|Mean
814640|NCT01090076|Primary|% Wound Area Week 1|Percentage change in wound area after week 1|week 0 to 1|||percent change||Standard Error|Mean
814641|NCT01090076|Primary|% Viable Tissue|"-Percentage viable tissue after 2 weeks
The estimated change in proportion of viable and non-viable tissue was determined using area derived from planimetry via acetate tracings. The description of viable tissue was taken to mean granulating (red) or epithelising (pink) tissue, and non-viable tissue were taken as necrotic (black) or sloughy (green or yellow) tissue."|weeks 1 to 2|||Percentage of viable tissue||Standard Error|Mean
814642|NCT01090102|Secondary|Log(10) Change in % Activated (CD38+HLA-DR+)CD8+ T Cells After Treatment Crossover|Log(10) change in the percentage of activated T cells during the second 12 weeks of the study|Week 12, Week 24|||Log10(percentage of T cells)||95% Confidence Interval|Mean
814643|NCT01090102|Primary|Log(10) Change in % Activated (CD38+HLA-DR+)CD8+ T Cells During the First 12 Weeks of Study||Week 0, Week 12|1 participant assigned to first receive Mesalamine was excluded from analysis due to having withdrawn participation without receiving the allocated intervention||Log10(percentage of T cells)||95% Confidence Interval|Mean
814644|NCT01090180|Secondary|Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR). Because Depression Can be Comorbid With PTSD (70% Comorbidity Found in Pilot Sample), This Assessment Will be Used to Measure Depressive Symptoms Over a 1 Week Timeframe|The QIDS-SR is a 16-item measure of depression symptom severity with a range from 0-27. Each item is rated from 0-3 with higher scores are indicative of higher symptom severity. Scores of the items are aggregated (with the highest score on overlapping items chosen; e.g., sleep disturbances, changes in eating) to generate the total score..|This measure will be administered at all study visits: Baseline, 1 month, 3 months, and 6 months follow up.|||units on a scale||Standard Deviation|Mean
814645|NCT01090180|Primary|PTSD Checklist (PCL). A Self-report, Face Valid Measure of PTSD Symptoms Over a 1 Week Time Period|The PCL is a 17-item measure of PTSD symptom severity with a range from 17-85. Each item is rated from 1-5 with higher scores are indicative of higher symptom severity. Scores of the 17 items are summed in order to generate the total score.|This measure will be administered at all study visits: Baseline, 1 month, 3 months, and 6 months follow up.|Male veterans with combat-related PTSD||units on a scale||Standard Deviation|Mean
814646|NCT01090310|Secondary|Composite Immunosuppressive Medication Score From Baseline to Week 52, Core and Extension|IMS is a combined, single numeric score derived on the basis of the total daily dose of specific immunosuppressive agents per unit body weight, ranged on a scale from 0 to 9 for the total daily dose in milligrams per kilogram. The total IMS is the sum of the scores derived for the agents included into the score. The treatment groups will be compared using an analysis of covariance with treatment, region, and baseline IMS as covariate. The total IMS is the sum of scores derived from the agents included into the score, and ranged from 0 to 55. Treatment groups compared using analysis of covariance with treatment & baseline IMS as covariate, where the lower IMS showed better clinical outcome.|Baseline to 52 weeks|Full analysis set (FAS): all randomized patients who received at least one dose of study drug in the core study and had at least one post-baseline assessment for the primary efficacy parameter or any of its components. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization||Units on a scale||Standard Deviation|Mean
814647|NCT01090310|Secondary|Number of Participants With First Recurrence in in Any Eye of Active Intermediate, Posterior, or Panuveitis From Baseline During the Core and Extension Studies|Evaluation of recurrence until resolution is ascertained, based on the first criteria (a >2 step increase in vitreous haze with or without an increase in anterior chamber cell grade in either eye). A 2 step increase is defined as any of the following changes: 0-2, 0.5-2, 1-3, 2-4|Baseline to 52 weeks|Full analysis set (FAS): all randomized patients who received at least one dose of study drug in the core study and had at least one post-baseline assessment for the primary efficacy parameter or any of its components. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization||Number of participants|||Number
814648|NCT01090310|Secondary|Mean Change in Best Corrected Visual Acuity From Baseline, Core and Extension|The Best Corrected Visual Acuity (BCVA) is tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) testing protocol. VA measurements are taken in a sitting position at an initial test distance of 4 meters using ETDRS charts. The overall BCVA score is calculated using the BCVA worksheet 0-100 letter score|Baseline to 52 weeks|Full analysis set (FAS): all randomized patients who received at least one dose of study drug in the core study and had at least one post-baseline assessment for the primary efficacy parameter or any of its components. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization||Letters||Standard Deviation|Mean
814649|NCT01090310|Secondary|Change in Vitreous Haze Score for the Study Eye From Baseline to the Highest Post-baseline Value|The changes in steps (0, 1, or >= 2) from previous visit for vitreous haze, where the score is evaluated based on NEI Vitreous Haze Grading Scale (0 -4). Vitreous haze was recorded as 0-clear; to 4+ as dense opacity obscuring the optic nerve head. A 1 step increase is defined as any of the following changes: 0-1, 0.5-1, 1-2, 2-3, 3-4. A 2 step increase is defined as any of the following changes: 0-2, 0.5-2, 1-3, 2-4. A recurrent episode of active intermediate, posterior or panuveitis was considered to be resolved, if the eye returns and maintains in a quiescent state (<1+ anterior chamber cell grade and <1+ vitreous haze) for at least 2 weeks|Baseline to 52 weeks|Full analysis set (FAS): all randomized patients who received at least one dose of study drug in the core study and had at least one post-baseline assessment for the primary efficacy parameter or any of its components. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization||Number of participants|||Number
814650|NCT01090310|Primary|The Time to the First Recurrence in Any Eye of Active Intermediate, Posterior, or Panuveitis From Baseline|Kaplan-Meier estimates for the time to the first recurrence in any eye of active intermediate, posterior, or panuveitis from baseline defined by either: ≥ 2 step increase in vitreous haze with or without an increase in anterior chamber cell grade or decrease in best corrected visual acuity, core and extension|Baseline to 52 weeks|Full analysis set (FAS): all randomized patients who received at least one dose of study drug in the core study and had at least one post-baseline assessment for the primary efficacy parameter or any of its components. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization||Days||95% Confidence Interval|Median
814651|NCT01090323|Secondary|Change in Serum Ferritin From Start of ICL670 to End of Study|The main efficacy variable was change in serum ferritin in response to therapy with ICL670. Due to variability of serum ferritin, end of study was considered as the mean of at most the last 3 available observations after the start of ICL670.|0 - 60 months|The primary analysis was on Full Analysis Set which comprised all participants who received at least one dose of ICL670 during the core or the extension phase of the study. All participants previously treated with ICL670 or DFO for 52 weeks in the core study were eligible for enrollment.||µg/L||Full Range|Median
814652|NCT01090323|Primary|Number of Participants With Adverse Events After Start of ICL670|Safety as assessed by the number of participants with adverse event or death after the start of ICL670.|0 - 60 months|The primary analysis was on Safety Analysis Set which comprised all participants who received at least one dose of ICL670 during the core/extension phase of the study. All participants previously treated with ICL670/DFO for 52weeks in the core study.||participants|||Number
814807|NCT01091948|Secondary|Successful Intubation on 1st Attempt||from start of first intubation to end of first intubation attempt|||participants|||Number
814661|NCT01090453|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Any SAE = any SAE regardless of assessment of relationship to study vaccination.|During the entire study period (Month 0 to Month 11)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.||Subjects|||Number
814808|NCT01091948|Secondary|Intubation Difficulty Score|Intubation difficulty score is a 100-mm-long visual analogue scale (100 mm = extremely difficult);|from start of intubation to successfully intubated|||units on a scale||Inter-Quartile Range|Median
816919|NCT01116882|Secondary|Any Repeat Revascularization||30 days|The denominator for any repeat revascularization at 30 days is defined as patients who either had the event to 30d or had follow up of at least 23 days.||participants|||Number
814662|NCT01090453|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).|An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an AE regardless of intensity grade or relationship to study vaccination.|Within the 31-day (Days 0-30) follow up period after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.||Subjects|||Number
814663|NCT01090453|Secondary|Number of Subjects Reporting Any Solicited General Symptoms.|Solicited local symptoms assessed were drowsiness, irritability/fussiness, loss of appetite and fever [axillary temperature above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any local symptom regardless of intensity grade.|During the 8-day (Days 0-7) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and the symptom sheet completed.||Subjects|||Number
814664|NCT01090453|Secondary|Number of Subjects Reporting Any Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.|During the 8-day (Days 0-7) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and the symptom sheet completed.||Subjects|||Number
814665|NCT01090453|Secondary|Anti-PRP and rSBA-MenC Fold Increase Distribution.|The fold increase distribution cut-offs were: ≥2, ≥4, ≥6, ≥8 and ≥10.|At Month 11.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.||Subjects|||Number
814666|NCT01090453|Secondary|Concentrations for Anti-PNE Serotypes.|Concentrations were expressed as geometric mean concentreations (GMCs). The reference cut-off value was ≥ 0.2 µg/mL.|At Month 3 and Month 11|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.||µg/mL||95% Confidence Interval|Geometric Mean
814667|NCT01090453|Secondary|Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs.|The anti-PNE antibody concentrations reference cut-offs were ≥ 0.2 and ≥ 0.05 micrograms per milliliter (µg/mL). The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.|At Month 3 and Month 11|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.||Subjects|||Number
814668|NCT01090453|Secondary|Number of Subjects With a Booster Response to Anti-PT, Anti-FHA and Anti-PRN.|Booster response defined as: for initially seronegative subjects, antibody concentration ≥ 5 EL.U/mL at Month 11; for initially seropositive subjects: antibody concentration at Month 11 ≥ 2 fold the pre-vaccination antibody concentration|At Month 11.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.||Sujects|||Number
814669|NCT01090453|Secondary|Concentrations for Anti-PT, Anti-FHA and Anti-PRN.|Concentrations were expressed as geometric mean concentrations (GMCs). The reference cut-off value was ≥ 5 EL.U/mL.|At Month 3, Month 10 and Month 11.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.||EL.U/mL||95% Confidence Interval|Geometric Mean
814670|NCT01090453|Secondary|Number Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Above the Cut-off.|The reference cut-off for anti-PT, anti-FHA and anti-PRN antibody concentrations was ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliters (EL.U/mL).|At Month 3, Month 10 and Month 11.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.||Subjects|||Number
814671|NCT01090453|Secondary|Titers for Anti-polio 1, 2 and 3.|Titers were expressed as geometric mean titers (GMTs). The reference cut-off value was ≥ 1:8.|At Month 3, Month 10 and Month 11.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.||titers||95% Confidence Interval|Geometric Mean
814672|NCT01090453|Secondary|Number of Subjects With Anti-poliovirus (Anti-polio) Types 1, 2 and 3 Above the Cut-off.|The anti-polio 1, 2 and 3 antibody concentrations cut-off value was ≥ 1:8.|At Month 3, Month 10 and Month 11.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.||Subjects|||Number
814673|NCT01090453|Primary|Number of Subjects With Neisseria Meningitidis Using Baby Rabbit Complement (rSBA-MenC) Antibodies Above the Cut-offs.|The rSBA-MenC cut-offs were ≥ 1:8 and ≥ 1:128. The results for Month 3 ≥ 1:8 were the primary efficacy variables.|At Month 3, Month 10 and Month 11.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.||Subjects|||Number
814674|NCT01090453|Secondary|Concentrations for Anti-HBs.|A decrease in the specificity of the anti-HB enzyme-linked immunosorbent assay (ELISA) had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis.|At Month 3, Month 10 and Month 11.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.||mIU/mL||95% Confidence Interval|Geometric Mean
814675|NCT01090453|Secondary|Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 10 and 100 Milli-International Units Per Milliliter (mIU/mL)|A decrease in the specificity of the anti-HB enzyme-linked immunosorbent assay (ELISA) had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis.|At Month 3, Month 10 and Month 11.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.||Subjects|||Number
814676|NCT01090453|Secondary|Concentrations for Anti-T and Anti-D.|Concentrations were expressed as geometric mean concentrations (GMCs). The reference cut-off value was ≥ 0.1 IU/mL.|At Month 3, Month 10 and Month 11.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.||IU/mL||95% Confidence Interval|Geometric Mean
814677|NCT01090453|Secondary|Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies Above the Cut-off.|The anti-D and anti-T antibody cut-off was ≥ 0.1 international units per milliliter (IU/mL).|At Month 3, Month 10 and Month 11.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.||Subjects|||Number
814678|NCT01090453|Secondary|Titers for rSBA-MenC.|Titers were expressed as geometric mean titers (GMCs). The seropositivity reference cut-off values were ≥ 1:8 and ≥ 1:128.|At Month 3, Month 10 and Month 11.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.||titers||95% Confidence Interval|Geometric Mean
814679|NCT01090453|Secondary|Concentrations for Anti-PRP.|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off values were ≥ 0.15 µg/mL and ≥ 1.0 µg/mL.|At Month 3, Month 10 and Month 11.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.||µg/mL||95% Confidence Interval|Geometric Mean
814680|NCT01090453|Primary|Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Above the Cut-offs.|The anti-PRP antibody concentrations cut-off was ≥ 0.15 and ≥ 1.0 micrograms per milliliter (µg/mL). The results for Month 3 ≥ 0.15 µg/mL were the primary efficacy variables.|At Month 3, Month 10 and Month 11.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.||Subjects|||Number
814681|NCT01090479|Secondary|Qualitative and Quantitative Bacterial Cultures of the Operative Shoulder Just Prior to Surgery||7 days||||||
814682|NCT01090479|Primary|Number of Patients With a Clinically Diagnosed Infection||2 months post-operatively|||participants|||Number
814683|NCT01090739|Other Pre-specified|Change in Health Resource Usage: # Physician Visits Due to FI|Change in health resource usage using sponsor-created questionnaire|36 Month Follow-up Visit|All implanted subjects||physician visits||Standard Deviation|Mean
814684|NCT01090739|Other Pre-specified|Change in Health Resource Usage: # Days in Hospital, Took Off Work, or Others Took Off Work Due to FI|Change in health resource usage using sponsor-created questionnaire|36 Month Follow-up Visit|All implanted subjects||days||Standard Deviation|Mean
814685|NCT01090739|Other Pre-specified|Change in Health Resource Usage: # Pads Per Day Subject Took for FI|Change in health resource usage using sponsor-created questionnaire: # days in hospital due to FI|36 Month Follow-up Visit|All implanted subjects||pads per day||Standard Deviation|Mean
814686|NCT01090739|Other Pre-specified|Change in the Haff Surgical Satisfaction Questionnaire (SSQ-8)|The SSQ-8 is an 8 item questionnaire to assess subject surgical satisfaction as described by Murphy M, Sternschuss G, Haff R, van Raalte H, Saltz S, Lucente V. Quality of life and surgical satisfaction after vaginal reconstructive vs. obliterative surgery for the treatment of advanced pelvic organ prolapse. Am J Obstet Gynecol. 2008 May;198(5):573.e1-7. The SSQ-8 was collected as an optional one-time assessment from implanted subjects between the 3 and 36 month visits. Scale is scored on 0-100 with higher scores are better|36 Month Follow-up Visit|All implanted subjects||units on a scale||Standard Deviation|Mean
814687|NCT01090739|Secondary|Change in Numeric Pelvic Pain Scale (NPPS)|Numeric Pelvic Pain Scale (NPPS) adapted from McCafferty M, Pasero C. Pain: Clinical Manual. 2nd ed. Philadelphia: Mosby Inc.; 1999. Chapter 3, Assessment Tools; p. 58-75. The NPPS is scored on a 0-10 scale with higher scores indicating more severe pain. Since the NPPS was introduced later in the study, earlier implanted subjects did not have the baseline NPPS score and a change from baseline could not be calculated.|12 Month Follow-up Visit|All subjects implanted at the time the NPPS was implemented in the study||units on a scale||Standard Deviation|Mean
814688|NCT01090739|Secondary|Change in Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12)|Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) as described by Rogers RG, Coates KW, Kammerer-Doak D, Khalsa S, Qualls C. A short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Int Urogynecol J Pelvic Floor Dysfunct. 2003 Aug;14(3):164-8; discussion 168. Measured on a 0-48 scale with higher scores equal to better sexual function.|36 Month Follow-up Visit|All subjects implanted||units on a scale||Standard Deviation|Mean
814689|NCT01090739|Secondary|Change in Pelvic Floor Impact Questionnaire (PFIQ-7) Scores|"Short-form version of the Pelvic Floor Impact Questionnaire (PFIQ-7) as described by Barber et al., 2005 (Barber MD, Walters MD, Bump RC. Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFDI-20 and PFIQ-7. Am J Obstet Gynecol. 2005 Jul;193(1):103-13).
The short-form version of the Pelvic Floor Impact Questionnaire has a total of 7 questions and 3 scales (Urinary Impact, Pelvic Organ Prolapse Impact, and Colorectal-Anal Impact). Total PFIQ score measured on a 0-300 scale with higher scores equal to greater pelvic floor impact. Subscales scored on 0-100 scale and the higher the score the greater pelvic floor impact, exactly like the Total PFIQ score."|36 Month Follow-up Visit|All subjects implanted||units on a scale||Standard Deviation|Mean
814690|NCT01090739|Secondary|Change in Pelvic Floor Distress Inventory (PFDI-20) Scores|"Short-form version of the Pelvic Floor Distress Inventory (PFDI-20) as described by Barber et al., 2005 (Barber MD, Walters MD, Bump RC. Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFDI-20 and PFIQ-7. Am J Obstet Gynecol. 2005 Jul;193(1):103-13).
The short-form version of the Pelvic Floor Distress Inventory has a total of 20 questions and 3 scales (Urinary Distress Inventory, Pelvic Organ Prolapse Distress Inventory, and Colorectal-Anal Distress Inventory). Total PFDI score measured on a 0-300 scale with higher scores equal to greater pelvic floor distress. As with the Total PFDI Score, higher subscale scores equal greater pelvic floor distress, on a 0-100 scale."|36 Month Follow-up Visit|All subjects implanted||units on a scale||Standard Deviation|Mean
814691|NCT01090739|Secondary|Change in Fecal Incontinence Quality of Life Score|Fecal Incontinence Quality of Life Score as described by Rockwood et al., 2000 (Rockwood TH, Church JM, Fleshman JW, Kane RL, Mavrantonis C, Thorson AG, Wexner SD, Bliss D, Lowry AC. Fecal Incontinence Quality of Life Scale: quality of life instrument for patients with fecal incontinence. Dis Colon Rectum. 2000 Jan;43(1):9-16; discussion 16-7). Four domains of lifestyle, coping, depression, and embarrassment. Measured on a 0-4 scale with higher scores equal to better quality of life.|36 Month Follow-up Visit|All subjects implanted||units on a scale||Standard Deviation|Mean
814692|NCT01090739|Secondary|Change in Wexner Symptom Severity Score|Wexner Symptom Severity Score for fecal incontinence (also known as the Cleveland Clinic Incontinence Score) as described by Jorge and Wexner, 1993 (Jorge JM, Wexner SD. Etiology and management of fecal incontinence. Dis Colon Rectum. 1993 Jan;36(1):77-97). Measured on a 0-20 scale with lower scores equal to less fecal incontinence.|36 Month Follow-up Visit|All subjects implanted||units on a scale||Standard Deviation|Mean
814693|NCT01090739|Secondary|Change in Urge Fecal Incontinence Episodes|Number of urge fecal incontinence episodes in a 14 day period|36 Month Follow-up Visit|All subjects implanted||urge fecal incontinent episodes/14 days||Full Range|Median
814694|NCT01090739|Secondary|Change in Fecal Incontinence Days|Number of fecal incontinence days in a 14 day period|36 Month Follow-up Visit|All subjects implanted||fecal incontinent days/14 days||Full Range|Median
814695|NCT01090739|Secondary|Change in Fecal Incontinence Episodes|Number of fecal incontinence episodes in a 14 day period|36 Month Follow-up Visit|All subjects implanted||fecal incontinent episodes/14 days||Full Range|Median
814696|NCT01090739|Primary|Percentage of Responders|The primary endpoint for efficacy is the 14 day bowel diary documenting liquid or solid fecal incontinence episodes. A 50% reduction in the number of FI episodes is considered a treatment responder.|12 Months|All subjects implanted||percentage of treatment responders||95% Confidence Interval|Number
814697|NCT01090752|Secondary|Effects of Pioglitazone on Salt Sensitivity||2009||06/2010||||
814698|NCT01090752|Primary|Effects of Pioglitazone on 24h Blood Pressure Control|24 hour blood pressure measurements were performed after each treatment/diet phase|march 2009|||mmHg||Standard Error|Mean
814699|NCT01090752|Primary|Effects of Pioglitazone on Sodium and Lithium Clearances|At the end of each treatment and diet phase, 24 urine collections were collected for the determination of sodium and lithium clearances|2007|||ml/min||Standard Error|Mean
814700|NCT01090752|Primary|Effects of Pioglitazone on Renal Hemodynamics|At the end of each treatment diet phase, renal clearances were performed for the determination of GFR and RBF|2008|||ml/min/1.73m2||Standard Error|Mean
814701|NCT01090765|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|43 months, 5 days|||participants|||Number
814702|NCT01090765|Primary|Phase I: Maximum Tolerated Dose (MTD) of TRC105 Given Every Two Weeks.|The MTD, to be administered in the phase II portion, is defined as the highest dose studied for which the incidence of dose limiting toxicity (DLT) was less than 33%. TRC105 was administered at 20 mg/kg intravenous every two weeks until MTD was achieved.|6 months|||mg/kg every 2 weeks|||Number
814703|NCT01090973|Secondary|Number of Participants With Adverse Events (AEs)|"Investigators intended to evaluate the safety and tolerability profile of LBH589. Assessments would consist of monitoring and recording all adverse events and serious adverse events, the regular monitoring of hematology, blood chemistry and urine values, vital signs, ECOG performance status, and the regular physical examinations and ECG assessments.
Adverse events will be assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 3.0. CTCAE v3.0 can be accessed on the National Institute of Health (NIH)/NCI website at http://ctep.cancer.gov/forms/CTCAEv3.pdf."|8 weeks (2 cycles) unless treatment continues due to partial or complete response|"The study was abandoned after only one patient due to low accrual and the sponsor losing interest in the single-agent.
The one patient had disease progression requiring more aggressive treatment and did not complete the study."||participants|||Number
814809|NCT01091948|Primary|Time to Intubation (TTI) as Measured in Seconds|Time from insertion of either the GlideScope or in the case of fibreoptic intubation, a Williams airway (SunMed, Largo, FL, USA) into the mouth, to the time when end-tidal PCO2 exceeded 2.7 kPa (20 mmHg).|from start of intubation to successfully intubated up to 100 seconds|||seconds||Inter-Quartile Range|Median
816920|NCT01116882|Secondary|Rate of Stent Thrombosis||30 days|||participants|||Number
814704|NCT01090973|Secondary|Number of Participants With Improved Blood and Lymphatic Evaluation Results|Investigators intended to evaluate histone acetylation, cytotoxic mixed lymphocyte reaction (MLR) activity, cytokine profiles, and immunologic synapse alterations through peripheral blood correlative studies|8 weeks (2 cycles) unless treatment continues due to partial or complete response|"The study was abandoned after only one patient due to low accrual and the sponsor losing interest in the single-agent.
The one patient had disease progression requiring more aggressive treatment and did not complete the study."|||||
814705|NCT01090973|Secondary|Number of Participants With Prolonged Corrected QT (QTc) Interval|Investigators intended to monitor the QTc interval in patients receiving oral LBH589|8 weeks (2 cycles) unless treatment continues due to partial or complete response||||||
814706|NCT01090973|Secondary|Progression Free Survival (PFS) Estimate|Investigators intended to estimate the progression free survival time|8 weeks (2 cycles) unless treatment continues due to partial or complete response|"The study was abandoned after only one patient due to low accrual and the sponsor losing interest in the single-agent.
The one patient had disease progression requiring more aggressive treatment and did not complete the study."|||||
814707|NCT01090973|Secondary|Response Duration|Investigators intended to determine the duration of responses.|8 weeks (2 cycles) unless treatment continues due to partial or complete response|"The study was abandoned after only one patient due to low accrual and the sponsor losing interest in the single-agent.
The one patient had disease progression requiring more aggressive treatment and did not complete the study."|||||
814708|NCT01090973|Secondary|Number of Participants With Complete Response (CR) and Partial Response (PR)|"Investigators intended to determine the complete and partial responses. Chronic Lymphocytic Leukemia (CLL): Using the NCI criteria - - See definitions in the Detailed Description section for a Complete hematologic Remission, and Partial Response.
Mantle Cell Lymphoma (MCL): Based on the International Workshop to Standardize Response Criteria to NHL (Cheson, JCO 1999) - See definitions in the Detailed Description section for a Complete hematologic Remission, and Partial Response."|8 weeks (2 cycles) unless treatment continues due to partial or complete response|"The study was abandoned after only one patient due to low accrual and the sponsor losing interest in the single-agent.
The one patient had disease progression requiring more aggressive treatment and did not complete the study."|||||
814709|NCT01090973|Primary|Number of Participants With Desired Response|"Investigators intended to assess the rate of overall and complete response by World Health Organization (WHO) classification in patients with relapsed or refractory aggressive mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL).
WHO Performance Scale Measures levels of patient capability: 0 Normal activity; 1 Symptoms, but nearly fully ambulatory; 2 Some bed time, but needs to be in bed <50% of normal daytime; 3 Needs to be in bed >50% of normal daytime; 4 Unable to get out of bed."|8 weeks (2 cycles) unless treatment continues due to partial or complete response|"The study was abandoned after only one patient due to low accrual and the sponsor losing interest in the single-agent.
The one patient had disease progression requiring more aggressive treatment and did not complete the study."|||||
814710|NCT01091103|Secondary|Change From Baseline in Urinary N-Telopeptide|Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 65.|Baseline, Week 65|Participants who received any amount of enzalutamide and had urinary N-telopeptide measurements at baseline and at Week 65.||mmol/mmol creatinine||Standard Deviation|Mean
814711|NCT01091103|Secondary|Change From Baseline in Urinary N-Telopeptide|Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 57.|Baseline, Week 57|Participants who received any amount of enzalutamide and had urinary N-telopeptide measurements at baseline and at Week 57.||mmol/mmol creatinine||Standard Deviation|Mean
814712|NCT01091103|Secondary|Change From Baseline in Urinary N-Telopeptide|Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 49.|Baseline, Week 49|Participants who received any amount of enzalutamide and had urinary N-telopeptide measurements at baseline and at Week 49.||mmol/mmol creatinine||Standard Deviation|Mean
814713|NCT01091103|Secondary|Change From Baseline in Urinary N-Telopeptide|Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 41.|Baseline, Week 41|Participants who received any amount of enzalutamide and had urinary N-telopeptide measurements at baseline and at Week 41.||mmol/mmol creatinine||Standard Deviation|Mean
814714|NCT01091103|Secondary|Change From Baseline in Urinary N-Telopeptide||Baseline, Week 33|Participants who received any amount of enzalutamide and had urinary N-telopeptide measurements at baseline and at Week 33.||mmol/mmol creatinine||Standard Deviation|Mean
814715|NCT01091103|Secondary|Change From Baseline in Urinary N-Telopeptide|Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 25.|Baseline, Week 25|Participants who received any amount of enzalutamide and had urinary N-telopeptide measurements at baseline and at Week 25.||mmol/mmol creatinine||Standard Deviation|Mean
814716|NCT01091103|Secondary|Change From Baseline in Urinary N-Telopeptide|Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 17.|Baseline, Week 17|Participants who received any amount of enzalutamide and had urinary N-telopeptide measurements at baseline and at Week 17.||mmol/mmol creatinine||Standard Deviation|Mean
814717|NCT01091103|Secondary|Change From Baseline in Urinary N-Telopeptide|Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 9.|Baseline, Week 9|Participants who received any amount of enzalutamide and had urinary N-telopeptide measurements at baseline and at Week 9.||mmol/mmol creatinine||Standard Deviation|Mean
814718|NCT01091103|Secondary|Change From Baseline in Urinary N-Telopeptide|Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 5.|Baseline, Week 5|Participants who received any amount of enzalutamide and had urinary N-telopeptide measurements at baseline and at Week 5.||mmol/mmol creatinine||Standard Deviation|Mean
814719|NCT01091103|Secondary|Median Time to Study Drug Discontinuation|Exposure to study drug through the data cutoff of 26AUG2011 only. Fifteen participants (25.0%) were still on study drug as of the data cut-off date and were censored at this date.|Duration of study treatment through the data cutoff, up to 3 years.|All participants who received any amount of enzalutamide. Fifteen (25.0%) participants were still on study drug as of the data cutoff date and were censored at the data cutoff date.||months||95% Confidence Interval|Median
814720|NCT01091103|Primary|Change From Baseline in Bone Marrow Dihydrotestosterone at Week 9 by Prostate-Specific Antigen (PSA) Response Status|"Bone marrow biopsies were performed at the Day 1 visit prior to initiation of enzalutamide administration. Repeat bone marrow biopsies were performed at the Week 9 visit. If a repeat bone marrow was not performed at the Week 9 visit or if a patient discontinued the study before the Week 9 visit, a bone marrow biopsy was obtained at the Safety Follow-up visit. Assessment of intratumoral dihydrotestosterone was assessed by liquid chromatography mass spectrometry.
Serum samples for measurement of PSA levels were obtained at baseline prior to initiation of enzalutamide administration and at the Week 9 visit.
The change from baseline in bone marrow dihydrotestosterone levels at Week 9 was correlated with PSA response status at Week 9."|Baseline, Week 9|Participants who received any amount of enzalutamide and had bone marrow dihydrotestosterone measurements at baseline and at least 1 post-baseline assessment. Note that the documentation of bone marrow involvement with cancer was not required.||ng/mL||Standard Deviation|Mean
814721|NCT01091103|Primary|Change From Baseline in Bone Marrow Testosterone at Week 9 by Prostate-Specific Antigen (PSA) Response Status|"Bone marrow biopsies were performed at the Day 1 visit prior to initiation of enzalutamide administration. Repeat bone marrow biopsies were performed at the Week 9 visit. If a repeat bone marrow was not performed at the Week 9 visit or if a patient discontinued the study before the Week 9 visit, a bone marrow biopsy was obtained at the Safety Follow-up visit. Assessment of intratumoral testosterone was assessed by liquid chromatography mass spectrometry.
Serum samples for measurement of PSA levels were obtained at baseline prior to initiation of enzalutamide administration and at the Week 9 visit.
The change from baseline in bone marrow testosterone levels at Week 9 was correlated with PSA response status at Week 9."|Baseline, Week 9|Participants who received any amount of enzalutamide and had bone marrow testosterone measurements at baseline and at least 1 post-baseline assessment. Note that the documentation of bone marrow involvement with cancer was not required.||ng/mL||Standard Deviation|Mean
814722|NCT01091103|Primary|Change From Baseline in Bone Marrow Dihydrotestosterone|"Bone marrow biopsies were performed at the Day 1 visit prior to initiation of enzalutamide administration. Repeat bone marrow biopsies were performed at the Week 9 visit. If a repeat bone marrow was not performed at the Week 9 visit or if a patient discontinued the study before the Week 9 visit, a bone marrow biopsy was obtained at the Safety Follow-up visit.
Assessment of intratumoral dihydrotestosterone was assessed by liquid chromatography mass spectrometry."|Baseline, Week 9|Participants who received any amount of enzalutamide and had bone marrow dihydrotestosterone measurements at baseline and at least 1 post-baseline assessment. Note that the documentation of bone marrow involvement with cancer was not required.||ng/mL||Standard Deviation|Mean
814723|NCT01091103|Secondary|Percentage of Participants at Week 9 With a Response in Prostate-Specific Antigen (PSA)|Serum samples for measurement of PSA levels were obtained at baseline prior to initiation of enzalutamide administration and at the Week 9 visit.|Baseline, Week 9|Participants who received any amount of enzalutamide and had PSA values at baseline and at the Week 9 Visit.||percentage of participants||95% Confidence Interval|Number
814724|NCT01091103|Primary|Change From Baseline in Bone Marrow Testosterone|"Bone marrow biopsies were performed at the Day 1 visit prior to initiation of enzalutamide administration. Repeat bone marrow biopsies were performed at the Week 9 visit. If a repeat bone marrow was not performed at the Week 9 visit or if a patient discontinued the study before the Week 9 visit, a bone marrow biopsy was obtained at the Safety Follow-up visit.
Assessment of intratumoral testosterone was assessed by liquid chromatography mass spectrometry."|Baseline, Week 9|Participants who received any amount of enzalutamide and had bone marrow testosterone measurements at baseline and at least 1 post-baseline assessment. Note that the documentation of bone marrow involvement with cancer was not required.||ng/mL||Standard Deviation|Mean
814725|NCT01091116|Secondary|Clinically Significant Abnormal Laboratory Tests|"Percentage of patients with Abnormal Laboratory Tests judged Clinically Significant by Investigators.
The following hematochemical and urinary parameters were analysed:
Red Blood Cells Count, Haematocrit, Haemoglobin, Platelets, MCV, MCH, MCHC, White Blood Cells, Sodium, Chloride, Potassium, Total calcium, AST (SGOT), ALT (SGPT), GGT, Alkaline phosphatase, Total Bilirubin, Direct Bilirubin, Creatinine, BUN, CPK, LDH, Glucose, Total proteins, Albumin."|up to 4 months from screening|Percentage of patients with clinically significant abnormal laboratory tests||participants|||Number
814726|NCT01091116|Secondary|Adverse Event Reports|Incidence of spontaneously reported adverse events|up to 4 months after screening|The number of patients reflects all patients administered at least one dose of the investigational product.||participants|||Number
814727|NCT01091116|Secondary|WOMAC VA 3.1A - Total Pain Score by Body Mass Index -[BMI > 25]|"Analysis in over-weight population (BMI > 25) of the WOMAC VA 3.1A score (range 0-500 mm) is reported.
A decrease of the WOMAC VA 3.1 A score following treatment administration indicates a reduction of pain symptom."|over the 3 weeks after the first administration|Population of Over Weight patients (BMI >25)||mm||Standard Deviation|Mean
814728|NCT01091116|Secondary|WOMAC VA 3.1A - Total Pain Score by Body Mass Index [BMI <= 25]|"Analysis in normal-weight population (BMI <= 25) of the WOMAC VA 3.1A score (range 0-500 mm) is reported.
A decrease of the WOMAC VA 3.1 A score following treatment administration indicates a reduction of pain symptom."|over the 3 weeks after the first administration|Population of Normal Weight patients (BMI <=25)||mm||Standard Deviation|Mean
814729|NCT01091116|Secondary|Patient Global Assessment|"Patient global assessment evaluated using a VAS scale score attributed by the patient (range 0-100 mm).
Efficacy assessed as change at each time-point post-dosing (week 1, 2 ,3, 13) versus baseline (week 0).
A decrease of patient global assessment score indicates an improvement of osteoarthritis symptoms."|up to 3 months after first dose|intention to treat (ITT) population||mm||Standard Deviation|Mean
814730|NCT01091116|Secondary|Percentage of Treatment Responders According to OMERACT-OARSI Responder Criteria|"Osteoarthritis Research Society International (OARSI).
Response defined as:
a decrease in WOMAC pain or physical-function score by 50% or more and by 20 or more points on the visual analogue scale
OR if two of the following three findings are recorded:
a decrease in the WOMAC pain score by 20% or more and by 10 or more points on the visual analogue scale; a decrease in the WOMAC physical-function score by 20% or more and by 10 or more points on the scale; an improvement in the score on the patient’s global assessment by 20% or more and by 10 or more points on the scale."|up to 3 months after first dose|intention to treat (ITT) population||percentage of patients|||Number
814833|NCT01085045|Secondary|Peak Change From BL IC on Day 7|Peak Change from Baseline Inspiratory Capacity on following 7-day dose administration|Day 7|MITT Population - not including the 4 sentinel patients.||Liters||95% Confidence Interval|Least Squares Mean
814731|NCT01091116|Secondary|WOMAC VA 3.1. C Score (Function)|"Knee function evaluated by WOMAC VA 3.1 C score (range 0-1700) is the sum of VAS scores (range 0-100 mm) attributed by the patient to each of 17 questions referring to difficulty in performing daily activities experienced during the preceding 48 hours.
The higher is the WOMAC VA 3.1 C score, the higher is functional impairment in daily activities (0 = no difficulty ; 1700 = extreme difficulty).
A decrease of the WOMAC VA 3.1 C score following treatment administration indicates an improvement in performing daily activities.
WOMAC VA 3.1.C scores at baseline and at Week 13 are reported."|up to 3 months after first dose|Intention to Treat (ITT) population||mm||Standard Deviation|Mean
814732|NCT01091116|Secondary|WOMAC VA 3.1.B Score (Knee Stiffness)|"WOMAC VA 3.1.B score(range 0-200) is the sum of VAS scores (0-100 mm)attributed by the patient to each of the 2 questions referring to joint stiffness experienced during the preceding 48 hours. The higher is the WOMAC VA 3.1 B score, the higher is joint stiffness (0 = no stiffness ; 200 = extreme stiffness).
A decrease of the WOMAC VA 3.1 B score following treatment administration indicates a reduction of joint stiffness.
The change at Week 13 from baseline is reported."|up to 3 months after first dose|Intention to Treat (ITT) population||mm||Standard Deviation|Mean
814733|NCT01091116|Primary|WOMAC VA 3.1 A Score (Total Pain)|"Western Ontario and McMaster Universities osteoarthritis index (WOMAC). The WOMAC VA 3.1 A score (total pain , range 0-500 mm) is the sum of VAS scores (0-100 mm) attributed by the patient to each of the 5 questions referring to osteoarthritic pain experienced during the preceding 48 hours.
The higher is the WOMAC VA 3.1 A score, the higher is the intensity of pain symptoms (0 = no pain ; 500 = extreme pain).
A decrease of the WOMAC VA 3.1 A score following treatment administration indicates a reduction of pain symptom.
The change from baseline was assessed along 3 weeks after first drug administrations."|over the 3 weeks after the first administration|analysis of the intention to treat (ITT) population||mm||Standard Deviation|Mean
814734|NCT01091155|Primary|Device Related Leak Rate up to 30 Days Post op|Anastomotic leakage will be defined as clinical symptoms such as fever or sepsis in combination with pelvic abscess, rectovaginal fistula or peritonitis within 30 days postoperatively leading to a clinical and / or radiological interventional procedure of the subject, or operation that confirms the leakage which has been determined to be related to the device.|30 days post op|||participants|||Number
814735|NCT01091155|Secondary|Rate of Other Device Related Complications and Other Parameters During Hospitalization and Post Procedure.|"The post operative parameters that will be measured during hospitalization period:
Hospitalization time (two dates will be recorded: ready for discharge and discharge). The later noting where the subject was discharged to - e.g. nursing home or home
First day to first postoperative flatus
First day to first postoperative bowel movements
First day of first postoperative toleration of liquids and solids (time to keeping them down)"|30 days post op||||||
814736|NCT01091155|Primary|To Evaluate Rate of Anastomotic Leaks Related to the Use of the ColonRing™ Device, at 1 Month|Anastomotic leakage will be defined as clinical symptoms such as fever or sepsis in combination with pelvic abscess, rectovaginal fistula or peritonitis within 30 days postoperatively leading to a clinical and / or radiological interventional procedure of the subject, or operation that confirms the leakage which has been determined to be related to the device.|Approx. 1 year||||||
814737|NCT01091246|Secondary|Percent of All Participants Reporting Any New Onset Chronic Disease (NOCD) From Administration of Investigational Product Through 180 Days Post Last Dose|An NOCD was a newly diagnosed medical condition that was of a chronic, ongoing nature and was assessed by the investigator as medically significant.|Days 0-180 Post Last Dose|All participants who received any investigational product (Q=1385; All FM=927) and for whom any safety data were recorded during the summarized period (Q=1382; All FM=923).||Percent of participants|||Number
814738|NCT01091246|Secondary|Percent of All Participants Reporting Any SAE From Administration of Investigational Product Through 180 Days Post Last Dose|SAEs were those AEs that resulted in death; were immediately life threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly in the offspring of a participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgement, may have jeopardized the participant and may have required medical or surgical intervention to prevent on the outcomes listed above.|Days 0-180 Post Last Dose|All participants who received any investigational product (Q=1385; All FM=927) and for whom any safety data were recorded during the summarized period (Q=1382; All FM=923).||Percent of participants|||Number
814739|NCT01091246|Secondary|Percent of Two-dose Participants Reporting Any SAE From Administration of Dose 2 During Days 0-28 Post Dose 2|SAEs were those AEs that resulted in death; were immediately life threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly in the offspring of a participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgement, may have jeopardized the participant and may have required medical or surgical intervention to prevent on the outcomes listed above.|Days 0-28 Post Dose 2|All two-dose participants who received any investigational product (Q=1083; All FM=719) and for whom any post Dose 2 safety data were recorded during the summarized period (Q=1041; All FM=693).||Percent of participants|||Number
814740|NCT01091246|Secondary|Percent of All Participants Reporting Any Serious Adverse Event (SAE) From Administration of Investigational Product Through Day 28 Post Dose 1|SAEs were those AEs that resulted in death; were immediately life threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly in the offspring of a participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgement, may have jeopardized the participant and may have required medical or surgical intervention to prevent on the outcomes listed above.|Days 0-28 Post Dose 1|All participants who received any investigational product (Q=1385; All FM=927) and for whom any safety data were recorded during the summarized period (Q=1382; All FM=923).||Percent of participants|||Number
814834|NCT01085045|Secondary|Peak Change From BL in Inspiratory Capacity on Day 1|Peak change from Baseline in Inspiratory Capacity (IC) on Day 1|Day 1|MITT Population - not including the 4 sentinel patients.||Liters||95% Confidence Interval|Least Squares Mean
816921|NCT01116882|Secondary|Ischemia-driven Target Vessel Revascularization||12 months|||participants|||Number
814741|NCT01091246|Secondary|Percent of Two-dose Participants Experiencing Any Adverse Event From Administration of Dose 2 Through 28 Days Post Dose 2|Any untoward medical occurrence in a patient or clinical investigation in a subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Days 0-28 Post Dose 2|All two-dose participants who received any investigational product (Q=1083; All FM=719) and for whom any post Dose 2 safety data were recorded during the summariezed period (Q=1041; All FM=693).||Percent of participants|||Number
814742|NCT01091246|Secondary|Percent of Two-dose Participants Experiencing Any Adverse Event From Administration of Investigational Product Through Day 28 Post Dose 1|Any untoward medical occurrence in a patient or clinical investigation in a subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Days 0-28 Post Dose 1|All two-dose participants who received any investigational product (Q=1083; All FM=719) and for whom any safety data were recorded during the summarized period (Q=1083; All FM=719).||Percent of Participants|||Number
814743|NCT01091246|Secondary|Percent of All Participants Experiencing Any Adverse Event From Administration of Investigational Product Through Day 28 Post Dose 1|Any untoward medical occurrence in a patient or clinical investigation in a subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Days 0-28 Post Dose 1|All participants who received any investigational product (Q=1385; All FM=927) and for whom any safety data were recorded during the summarized period (Q=1382; All FM=923).||Percent of Participants|||Number
814744|NCT01091246|Secondary|Percent of Two-dose Participants Experiencing Each Solicited Symptom From Administration of Dose 2 During Days 0-14 Post Dose 2|Solicited symptoms were fever ≥ 100.4°F (38.0°C), runny/stuffy nose, sore throat, cough, headache, generalized muscle aches, decreased activity level (lethargy) OR tiredness/weakness, decreased appetite. Collection of specific solicited symptoms (sore throat, headache, generalized muscle aches) was omitted when, according to the judgment of the investigator, the subject was too young to reliably report a particular symptom.|Days 0-14 Post Dose 2|All two-dose participants who received any investigational product (Q=1083; All FM=719) and for whom any follow-up solicited symptom safety data were recorded during the summarized period (Q=1039; All FM=692).||Percent of Participants|||Number
814745|NCT01091246|Secondary|Percent of Two-dose Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Dose 1|Solicited symptoms were fever ≥ 100.4°F (38.0°C), runny/stuffy nose, sore throat, cough, headache, generalized muscle aches, decreased activity level (lethargy) OR tiredness/weakness, decreased appetite. Collection of specific solicited symptoms (sore throat, headache, generalized muscle aches) was omitted when, according to the judgment of the investigator, the subject was too young to reliably report a particular symptom.|Days 0-14 Post Dose 1|All two-dose participants who received any investigational product (Q=1083; All FM=719) and for whom any follow-up solicited symptom safety data were recorded during the summarized period (Q=1078; All FM=716).||Percent of Participants|||Number
814746|NCT01091246|Secondary|Percent of All Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Dose 1|Solicited symptoms were fever ≥ 100.4°F (38.0°C), runny/stuffy nose, sore throat, cough, headache, generalized muscle aches, decreased activity level (lethargy) OR tiredness/weakness, decreased appetite. Collection of specific solicited symptoms (sore throat, headache, generalized muscle aches) was omitted when, according to the judgment of the investigator, the subject was too young to reliably report a particular symptom.|Days 0-14 Post Dose 1|All participants who received any investigational product (Q=1385; All FM=927) and for whom any follow-up solicited symptom safety data were recorded during the summarized period (Q=1377; All FM=920).||Percent of Participants|||Number
814747|NCT01091246|Secondary|Percent of Seronegative Participants Who Achieved a B/Victoria HAI Antibody Titer ≥ 32 Post Immunogenicity Dose|Seronegative was defined as a baseline HAI titer ≤ 4.|Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; FY=464), had post dose HAI antibody measurement at the appropriate time, had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and were seronegative to the strain (Q=487; FV=159).||Percent of Participants|||Number
814748|NCT01091246|Secondary|Percent of Seronegative Participants Who Achieved a B/Yamagata HAI Antibody Titer ≥ 32 Post Immunogenicity Dose|Seronegative was defined as a baseline HAI titer ≤ 4.|Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; FY=464), had post dose HAI antibody measurement at the appropriate time, had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and were seronegative to the strain (Q=483; FY=165).||Percent of participants|||Number
814749|NCT01091246|Secondary|Percent of Seronegative Participants Who Achieved an A/H3N2 HAI Antibody Titer ≥ 32 Post Immunogenicity Dose|Seronegative was defined as a baseline HAI titer ≤ 4.|Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; All FM=927), had post dose HAI antibody measurement at the appropriate time, had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and were seronegative to the strain (Q=364; All FM=244).||Percent of participants|||Number
814750|NCT01091246|Secondary|Percent of Seronegative Participants Who Achieved an A/H1N1 HAI Antibody Titer ≥ 32 Post Immunogenicity Dose|Seronegative was defined as a baseline HAI titer ≤ 4.|Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; All FM=927), had post dose HAI antibody measurement at the appropriate time, had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and were seronegative to the strain (Q=460; All FM=321).||Percent of participants|||Number
814835|NCT01085045|Secondary|Peak Change From BL in FEV1 on Day 7|Peak change from Baseline (BL) in FEV1 on Day 7|Day 7|MITT Population - not including the 4 sentinel patients.||Liters||95% Confidence Interval|Least Squares Mean
816922|NCT01116882|Secondary|Ischemia-driven Target Vessel Revascularization||30 days|||participants|||Number
814751|NCT01091246|Secondary|Percent of Serosusceptible Participants Who Achieved a B/Victoria HAI Antibody Titer ≥ 32 Post Immunogenicity Dose|Serosusceptible was defined as a baseline HAI titer ≤ 8.|Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; FV=463), had post dose HAI antibody measurement at the appropriate time, had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and were serosusceptible to the strain (Q=620; FV=191).||Percent of participants|||Number
814752|NCT01091246|Secondary|Percent of Serosusceptible Participants Who Achieved a B/Yamagata HAI Antibody Titer ≥ 32 Post Immunogenicity Dose|Serosusceptible was defined as a baseline HAI titer ≤ 8.|Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; FY=464), had post dose HAI antibody measurement at the appropriate time, had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and were serosusceptible to the strain (Q=588; FY=192).||Percent of participants|||Number
814753|NCT01091246|Secondary|Percent of Serosusceptible Participants Who Achieved an A/H3N2 HAI Antibody Titer ≥ 32 Post Immunogenicity Dose|Serosusceptible was defined as a baseline HAI titer ≤ 8.|Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; All FM=927), had post dose HAI antibody measurement at the appropriate time, had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and were serosusceptible to the strain (Q=435; All FM=298).||Percent of participants|||Number
814754|NCT01091246|Secondary|Percent of Serosusceptible Participants Who Achieved an A/H1N1 HAI Antibody Titer ≥ 32 Post Immunogenicity Dose|Serosusceptible was defined as a baseline HAI titer ≤ 8.|Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; All FM=927), had post dose HAI antibody measurement at the appropriate time, had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and were serosusceptible to the strain (Q=569; All FM=392).||Percent of participants|||Number
814755|NCT01091246|Secondary|Percent of Participants (Regardless of Serostatus) Who Achieved a B/Victoria HAI Antibody Titer ≥ 32 Post Immunogenicity Dose||Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; FV=463), had post dose HAI antibody measurement at the appropriate time, and had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response (Q=1327; FV=437).||Percent of participants|||Number
814756|NCT01091246|Secondary|Percent of Participants (Regardless of Serostatus) Who Achieved a B/Yamagata HAI Antibody Titer ≥ 32 Post Immunogenicity Dose||Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; FY=464), had post dose HAI antibody measurement at the appropriate time, and had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response (Q=1327; FY=445).||Percent of participants|||Number
814757|NCT01091246|Secondary|Percent of Participants (Regardless of Serostatus) Who Achieved an A/H1N1 or A/H3N2 Strain-specific HAI Antibody Titer ≥ 32 Post Immunogenicity Dose||Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; All FM=927), had post dose HAI antibody measurement at the appropriate time, and had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response (Q=1327; All FM=883).||Percent of participants|||Number
814758|NCT01091246|Secondary|Percent of Seronegative Participants Within Each Treatment Arm Who Experienced a Seroresponse to the B/Victoria Strain Post Immunogenicity Dose|Seronegative was defined as a baseline HAI titer ≤ 4. Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline.|Day 0 and Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; FV=463), had post dose HAI antibody measurement at the appropriate time, had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and were seronegative to the strain (Q=487; FV=159).||Percent of participants|||Number
814759|NCT01091246|Secondary|Percent of Seronegative Participants Within Each Treatment Arm Who Experienced a Seroresponse to the B/Yamagata Strain Post Immunogenicity Dose|Seronegative was defined as a baseline HAI titer ≤ 4. Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline.|Day 0 and Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; FY=464), had post dose HAI antibody measurement at the appropriate time, had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and were seronegative to the strain (Q=483; FY=165).||Percent of participants|||Number
814760|NCT01091246|Secondary|Percent of Seronegative Participants Within Each Treatment Arm Who Experienced a Seroresponse to the A/H3N2 Strain Post Immunogenicity Dose|Seronegative was defined as a baseline HAI titer ≤ 4. Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline.|Day 0 and Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; All FM=927), had post dose HAI antibody measurement at the appropriate time and had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response and were seronegative to the strain (Q=364; All FM=244).||Percent of participants|||Number
814761|NCT01091246|Secondary|Percent of Seronegative Participants Within Each Treatment Arm Who Experienced a Seroresponse to the A/H1N1 Strain Post Immunogenicity Dose|Seronegative was defined as a baseline HAI titer ≤ 4. Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline.|Day 0 and Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; All FM=927), had post dose HAI antibody measurement at the appropriate time, and had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response and were seronegative to the strain (Q=460; All FM=321).||Percent of participants|||Number
814762|NCT01091246|Secondary|Percent of Serosusceptible Participants Within Each Treatment Arm Who Experience Seroresponse to the B/Victoria Strain Post Immunogenicity Dose|Serosusceptible was defined as a baseline HAI titer ≤ 8. Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline.|Day 0 and Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; FV=463), had post dose HAI antibody measurement at the appropriate time, had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and were serosusceptible to the strain (Q=620; FV=191).||Percent of participants|||Number
816923|NCT01116882|Secondary|All Cause Mortality at 12 Months||12 months|||participants|||Number
814763|NCT01091246|Secondary|Percent of Serosusceptible Participants Within Each Treatment Arm Who Experience Seroresponse to the B/Yamagata Strain Post Immunogenicity Dose|Serosusceptible was defined as a baseline HAI titer ≤ 8. Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline.|Day 0 and Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; FY=464), had post dose HAI antibody measurement at the appropriate time, had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and were serosusceptible to the strain (Q=588; FY=192).||Percent of participants|||Number
814764|NCT01091246|Secondary|Percent of Serosusceptible Participants Within Each Treatment Arm Who Experience Seroresponse to the A/H3N2 Strain Post Immunogenicity Dose|Serosusceptible was defined as a baseline HAI titer ≤ 8. Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline.|Day 0 and Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; All FM=927), had post dose HAI antibody measurement at the appropriate time, had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and were serosusceptible to the strain (Q=435; All FM=298).||Percent of participants|||Number
814765|NCT01091246|Secondary|Percent of Serosusceptible Participants Within Each Treatment Arm Who Experienced a Seroresponse to the A/H1N1 Strain Post Immunogenicity Dose|Serosusceptible was defined as a baseline HAI titer ≤ 8. Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline.|Day 0 and Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; All FM=927), had post dose HAI antibody measurement at the appropriate time, had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and were serosusceptible to the strain (Q=569; All FM=392).||Percent of participants|||Number
814766|NCT01091246|Secondary|Percent of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Experienced a Seroresponse to the B/Victoria Strain Post Immunogenicity Dose|Seroresponse was defined as a ≥ 4-fold rise from baseline.|Day 0 and Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; FV=463), had post dose HAI antibody measurement at the appropriate time, and had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response (Q=1321; FV=437).||Percent of participants|||Number
814767|NCT01091246|Secondary|Percent of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Experienced a Seroresponse to the B/Yamagata Strain Post Immunogenicity Dose|Seroresponse was defined as a ≥ 4-fold rise in HAI antibody titer from baseline.|Day 0 and Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; FY=464), had post dose HAI antibody measurement at the appropriate time, and had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response (Q=1321; FY=441).||Percent of participants|||Number
814768|NCT01091246|Secondary|Percent of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Experienced a Seroresponse to the A/H3N2 Strain Post Immunogenicity Dose|Seroresponse was defined as a ≥ 4-fold rise in HAI antibody titer from baseline.|Day 0 and Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; All FM=927), had post dose HAI antibody measurement at the appropriate time and had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response (Q=1321; All FM=879).||Percent of participants|||Number
814769|NCT01091246|Secondary|The Percent of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Experienced a Seroresponse to the A/H1N1 Strain Post Immunogenicity Dose|Seroresponse was defined as a ≥ 4-fold rise in HAI antibody titer from baseline.|Day 0 and Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; All FM=927), had post dose HAI antibody measurement at the appropriate time, and had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response (Q=1320; All FM=878).||percent of participants|||Number
814770|NCT01091246|Primary|The 4 Post-dose Strain-specific Serum Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMT) in the Q/LAIV (MEDI3250) Arm Are Noninferior to Those in the Comparator FluMist Group.|Noninferior immune response was defined as having the upper bound of the 2-sided 95% confidence intervals (CIs) for the HAI antibody GMT ratio (FluMist comparator divided by Q/LAIV) ≤ 1.5 for each of the 4 strains. .|Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; FY=464; FV=463; All FM=927), had post dose HAI antibody measurement at the appropriate time and had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response (Q=1327; FY=445; FV=437; All FM=883).||Geometric mean titer||Full Range|Geometric Mean
814771|NCT01091259|Secondary|Number of Patients Who Experienced Grade 3 and Higher Toxicities||up to 3 years|Any patients who had at least one dose of treatment||participants|||Number
814772|NCT01091259|Secondary|Median Overall Survival|Defined as the length of time from the start of treatment that half of the patients are still alive.|up to 3 years|Intent-to-treat||months||95% Confidence Interval|Median
814773|NCT01091259|Secondary|Median Progression Free Survival|Defined as the length of time from the start of treatment that half of the patients are still alive and without disease progression. Progression is evaluated by RECIST 1.0 or CA125 if no measurable disease (PR: CA125 decreases by > 50%; CR: CA125 decreases to the normal range; progression is defined on the basis of a confirmed doubling of CA125 levels from either the upper limit of normal or the nadir CA125 level)|up to 3 years|Intent-to-treat||months||95% Confidence Interval|Median
814774|NCT01091259|Secondary|Overall Response Rate (ORR)|ORR is defined as the percentage of all patients with confirmed partial response (PR) or complete response (CR). PR and CR are evaluated by RECIST 1.0 or CA125 if no measurable disease (PR: CA125 decreases by > 50%; CR: CA125 decreases to the normal range).|up to 3 years|Intent-to-treat population||percentage of patients||95% Confidence Interval|Number
814836|NCT01085045|Secondary|Peak Change From BL in FEV1 on Day 1|Peak change from Baseline in FEV1 on Day 1|Day 1|MITT Population - not including the 4 sentinel patients.||Liters||95% Confidence Interval|Least Squares Mean
814837|NCT01085045|Primary|FEV1 AUC 0-12 on Day 7|Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-12 (normalized) relative to baseline FEV1 following 7-day dose administration|"Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 10, 11.5, and 12 hours post-dose on Day 7"|Modified Intent to Treat (MITT) Population - not including the 4 sentinel patients.||Liters||95% Confidence Interval|Least Squares Mean
814775|NCT01091259|Primary|Progression Free Survival (PFS) Rate at 6 Months|The PFS rate at 6 months is the percentage of patients that experience a PFS event during the first 6 months in the study. The PFS is defined as the time from date of first dose of study medication to the date of first documented disease progression, or death from any cause, whichever is first. Patients who die without a reported prior progression will be considered to have progressed on the day of their death. Progression is evaluated by Response and Evaluation Criteria in Solid Tumor (RECIST) 1.0 or CA125 criteria if no measurable disease as doubling of CA125 levels from either the upper limit of normal or the nadir CA125 level.|6 months from the start of treatment|Intent-to-treat population.||percentage of patients||95% Confidence Interval|Number
814776|NCT01091454|Secondary|Survival Time|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.|Up to 5 years|||months||95% Confidence Interval|Number
814777|NCT01091454|Secondary|Time to Disease Progression|Time to disease progression is defined as the time from registration to the earliest date of documentation of disease progression. If a patient dies without a documentation of disease progression the patient will be considered to have had disease progression at the time of their death. If the patient is declared to be a major treatment violation, the patient will be censored on the date the treatment violation was declared to have occurred. The distribution of time to progression will be estimated using the method of Kaplan-Meier. Progression is defined using the revised RECIST guideline (v1.1) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.|up to 5 years|||months||95% Confidence Interval|Median
814778|NCT01091454|Secondary|6-month Progression-free Survival (6-mo PFS) Rate|6-month progression-free survival. A patient is considered to be a 6-month progression-free survivor if the patient is on study treatment 6 months from registration without a documentation of disease progression. The 6-month progression-free survival rate incorporating censoring will be computed using the method of Kaplan-Meier. Progression is defined using the revised RECIST guideline (v1.1) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.|At 6 months|||proportion of participants||95% Confidence Interval|Number
814779|NCT01091454|Secondary|Duration of Response|Duration of response is defined for all evaluable patients with measurable disease who have achieved a confirmed response as the date at which the patient’s earliest best objective status is first noted to be either a CR or PR to the earliest date progression is documented. If a patient dies subsequent to the confirmed response without a documentation of disease progression, the patient will be considered to have had disease progression at the time of their death. The distribution of duration of response will be estimated using the method of Kaplan-Meier. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <1 cm.; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 5 years|||months||95% Confidence Interval|Median
814780|NCT01091454|Secondary|Confirmed Response Rate|A confirmed response is defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 6 weeks apart. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response. The confirmed response rate will be estimated by the number of confirmed responses in evaluable patients with measurable disease divided by the total number of evaluable patients with measurable disease. The appropriate confidence interval will be calculated. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <1 cm.; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 5 years|Out of the total number of participants who completed the study and were evaluable for the primary endpoint and adverse events (as provided in the Participant Flow), only a subset of participants (Overall Number of Participants Analyzed specified above) were evaluable for the Confirmed Response Rate.||percentage of confirmed responses||95% Confidence Interval|Number
814781|NCT01091454|Primary|3-month Progression-free Survival (3-mo PFS) Rate|A patient is considered to be a 3-month progression-free survivor if the patient is on study treatment 3 months from registration without a documentation of disease progression. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients and 95% confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner. If some patients are lost to follow-up not having been observed for at least 3 months, an estimate and confidence interval for the 3-month PFS rate incorporating censoring will be computed using the method of Kaplan-Meier. Progression is defined using the revised RECIST guideline (v1.1) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.|3 months|||proportion of participants||95% Confidence Interval|Number
814782|NCT01091519|Secondary|Number of Participants With Change From Baseline in Treatment Satisfaction Question (TSQ) at Week 4 and Month 4|Participant’s response to the treatment was based on treatment satisfaction questionnaires (TSQ). TSQ was rated on a 5–point scale, participant was asked: “overall how satisfied are you with your over active bladder (OAB) medication?” 1=very satisfied, 2=somewhat satisfied, 3=neither dissatisfied nor satisfied, 4=somewhat dissatisfied, 5=very dissatisfied. Change from baseline results categorized as deterioration (Positive change from baseline);no change (scores change=0);minor improvement (negative score change in magnitude of 1);major improvement (negative score change in magnitude of >=2).|Baseline, Week 4, Month 4|FAS included all participants who had received at least 1 dose of study medication and had provided at least 1 efficacy endpoint at baseline and during the study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.||participants|||Number
838804|NCT01313182|Secondary|Measure Hospital Length of Stay and Re-admission Rates in the Mupirocin and Povidone-iodine Groups.|Re-admission for infection within 12 months of procedure|12 months||||||
814783|NCT01091519|Secondary|Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 4 and Month 4|PPUS: single-item, self-administered validated questionnaire. Rated on a 3–point scale: participant was asked: “Which of the following would typically describe your experience when you have a desire to urinate?” 1=usually not able to hold urine; 2=usually able to hold urine (without leaking) until I reach a toilet if I go to the toilet immediately; 3= usually able to finish what I am doing before going to the toilet (without leaking). Change from baseline results categorized as deterioration (Negative change); no change (Score change=0); improvement (Positive change).|Baseline, Week 4, Month 4|FAS included all participants who had received at least 1 dose of study medication and had provided at least 1 efficacy endpoint at baseline and during the study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.||participants|||Number
814784|NCT01091519|Secondary|Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4 and Month 4|"PPBC: single-item, self-administered validated questionnaire. Rated on a 6–point scale: participant was asked: “Which of the following statements describes your bladder condition best at the moment? 1=no problems at all; 2=some very minor problems; 3=some minor problems; 4=some moderate problems; 5=severe problems; 6=many severe problems. Change from baseline results categorized as deterioration (Positive change from baseline); no Change (scores change=0); minor Improvement (negative score change in magnitude of 1); major improvement (negative score change in magnitude of >=2)."|Baseline, Week 4, Month 4|FAS included all participants who had received at least 1 dose of study medication and had provided at least 1 efficacy endpoint at baseline and during the study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.||participants|||Number
814785|NCT01091519|Primary|Percentage of Participants Satisfied With Treatment at Month 4|Participant’s response to treatment was based on treatment satisfaction questionnaires (TSQ). Participants answered: “overall, how satisfied are you with your OAB medication?” and were asked to rate this question on 5 point scale as 1=very satisfied, 2=somewhat satisfied, 3= neither dissatisfied nor satisfied, 4=somewhat dissatisfied and 5=very dissatisfied. Five categorical responses were grouped to satisfied (including “very satisfied” and “somewhat satisfied”) and dissatisfied (including “very dissatisfied”, “somewhat dissatisfied”, and “neither dissatisfied nor satisfied”).|Month 4|Full Analysis Set (FAS) included all participants who had received at least 1 dose of study medication and had provided at least 1 efficacy endpoint at baseline and during the study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||percentage of participants||95% Confidence Interval|Number
814786|NCT01091662|Secondary|Standardized Seizure Frequency (SSF) by Period|Seizure frequency was evaluated by using a standardized frequency per 4 weeks (28 days). It was evaluated for five periods: baseline (Weeks -8 to -1), titration (Weeks 1 to 2), AED taper/conversion (Weeks 3 to 8), monotherapy (Weeks 9 to 18), and double-blind (Weeks 1 to 18).|Double-blind: week to 18; Baseline: weeks -8 to -1; titration: weeks 1 to 2; AED taper/conversion weeks 3 to 8; monotherapy: weeks 9 to 18|efficacy population (ESL 1200 mg) Double-blind: 54; Baseline: 54; Titration: 54; AED taper/conversion; 54; Monotherapy: 48 (ESL 1600 mg) Double-blind: 100; Baseline: 98; Titration: 100; AED taper/conversion; 100; Monotherapy: 88||seizures in 28 days||Standard Deviation|Mean
814787|NCT01091662|Secondary|Proportion (%) of Events in Each Classification of the Columbia Suicide Severity Rating Scale (C SSRS).||18 Week Double-blind treatment period|ITT population||Percent of particiants|||Number
814788|NCT01091662|Secondary|Proportion (%) of Subjects With Normal Baseline Sodium Reaching Blood Sodium ≤135 mmol/L, ≤130 mmol/L, and ≤125 mmol/L.|Proportion (%) of Subjects With Normal Baseline Sodium Reaching Blood Sodium ≤135 mmol/L, ≤130 mmol/L, and ≤125 mmol/L|Week 0 to Week 18|ITT population||percentage of participants|||Number
814789|NCT01091662|Secondary|Proportion (%) of Subjects With Increase of Body Weight >= 7% From Baseline||18 Week Double-blind treatment period|ITT population||percentage of participants|||Number
814790|NCT01091662|Secondary|Change in Total Score of MADRS From Baseline in Those Subjects With a MADRS Score of ≥14 at Randomization.|The total score of MADRS is defined as the sum of all individual item scores. From 0-60, higher score indicates more severe|Week 0 to Week 18, baseline:day 0;end of AED taper/conversion period; end of week 8; end of monotherapy period: end of week 18|efficacy population (ESL 1200 mg) Change from baseline to end of AED taper/conversion period: 7; Change from baseline to end of monotherapy period: 7 (ESL 1600 mg) Change from baseline to end of AED taper/conversion period: 16; Change from baseline to end of monotherapy period: 18||units on a scale||Standard Deviation|Mean
814791|NCT01091662|Secondary|Change in Total Score in Montgomery-Asberg Depression Rating Scale (MADRS),From Baseline .|The total score of MADRS is defined as the sum of all individual item scores. From 0-60, high score indicates more severe|Week 0 to Week 18,baseline day 0; end of AED taper/conversion period; end of week 8; end of monotherapy period; end of week 18|Efficacy Population (ESL 1200 mg) Change from baseline to end of AED taper/conversion period: 48; Change from baseline to end of monotherapy period: 54 (ESL 1600 mg) Change from baseline to end of AED taper/conversion period: 88; Change from baseline to end of monotherapy period: 98||units on a scale||Standard Deviation|Mean
814792|NCT01091662|Secondary|Change in Total Score From Baseline in 31-Item Quality of Life in Epilepsy (QOLIE-31).|The QOLIE-31 overall score was obtained by using a weighted average of multi-item scale scores. The recorded responses were converted to 0-100 point scales. The mean of the individual item scores in each subgroup were calculated, with higher converted scores reflecting better quality of life.|Week 0 to Week 18, Baseline: Day 0: End of AED taper/conversion period: end of week 8; End of monotherapy period: end of week 18|Efficacy Population (ESL 1200 mg) Change from baseline to end of AED taper/conversion period: 45; Change from baseline to end of monotherapy period:50 (ESL1600 mg) Change from baseline to end of AED taper/conversion period: 85; Change from baseline to end of monotherapy period:96||units on a scale||Standard Deviation|Mean
814852|NCT01085214|Primary|Overall Response Rate|Overall Response: Stringent Complete Response (sCR) + Complete Response (CR) + Very Good Partial Response (VGPR) + Partial Response (PR).|Up to 2 years|All participants who received study treatment||participants|||Number
814853|NCT01085318|Other Pre-specified|Time to First Clinical Relapse|Time to First Clinical Relapse|Months|||months||Standard Deviation|Mean
814854|NCT01085318|Other Pre-specified|Clinical Relapses|Clinical Relapses|Over 6 months|||relapses per participant||Standard Deviation|Mean
814793|NCT01091662|Secondary|Proportion (%) of Subjects Reaching Each Exit Criteria|"The proportion (%) of subjects reaching each of the 5 exit criteria-1.One episode of status epilepticus.2.One secondary gen. partial seizure (in subjects who did not have gen.seizures during 6 mo. prior to screening).3.A two fold increase in any consecutive 28 day seizure rate compared to the highest consecutive 28 day seizure rate during the 8 week baseline period. 4.A two fold increase in any consecutive 2 day seizure rate compared to the highest consecutive 2 day seizure rate during the 8 week baseline period. If the highest number of seizures in any consecutive 2 day period during the 8 week baseline was 1 then 3 seizures in a consecutive 2 day period was required to exit.
5.Worsening of seizures or increase in seizure frequency considered serious or requiring intervention as judged by the investigator"|Week 1 to Week 18, (beginning of week 1 to end of week 18)|Efficacy population||percentage of participants|||Number
814794|NCT01091662|Secondary|Responder Rate (Proportion [%] of Subjects With a ≥50% Reduction of Seizure Frequency From Baseline).|Responder rate was defined as the proportion (%) of subjects with a ≥ 50% reduction of seizure frequency from baseline. This analysis was done for the titration (Weeks 1 to 2), AED taper/conversion (Weeks 3 to 8), monotherapy (Weeks 9 to 18), and double-blind (Weeks 1 to 18) periods.|Week 0 to Week 18, Double-blind weeks 1-18; baseline: weeks -8 to -1; Titration: weeks 1-2; AED taper/conversion; weeks 3-8; monotherapy weeks 9-18|Efficacy population||percentage of participants||95% Confidence Interval|Number
814795|NCT01091662|Secondary|Change in Seizure Frequency From Baseline.|The relative (%) change in standardized seizure frequency was evaluated for four periods: titration (Weeks 1 to 2), AED taper/conversion (Weeks 3 to 8), monotherapy (Weeks 9 to 18), and double-blind (Weeks 1 to 18).|18 weeks, Double-blind:weeks 1-18; Baseline: weeks -8to -1; titration: weeks 1 to 2; AED taper/conversion: weeks 3 to 8; monotherapy; weeks 9 to 18|Efficacy population (ESL 1200mg) Double-blind: 54; Titration: 54; AED taper/conversion:54; Monotherapy: 48 (ESL1600 mg) Double-blind:98; Titration: 98; AED taper/conversion: 98; Monotherapy: 87||Percent change||Inter-Quartile Range|Median
814796|NCT01091662|Secondary|Time on Eslicarbazepine Acetate Monotherapy.|The start of the monotherapy period was defined as the date of termination of all other AEDs while taking study monotherapy medication. Time on monotherapy was defined from the start of monotherapy period to the last dose of monotherapy treatment.|Week 8 to Week 18|Efficacy population||days||95% Confidence Interval|Median
814797|NCT01091662|Secondary|Completion Rate During the 10 Weeks of Monotherapy (% of Subjects Entering the Monotherapy Period Who Complete).|Monotherapy completion rate was defined as the proportion (%) of subjects entering the monotherapy period who completed the 10 weeks of monotherapy treatment.|Week 8 through 18|Efficacy population||percentage of participants||95% Confidence Interval|Number
814798|NCT01091662|Secondary|Completion Rate (% of Subjects Completing the 18 Weeks of Double-blind Treatment).|Subjects completing the study were determined as subjects who completed the 18 weeks of double-blind treatment.|18 weeks|Efficacy population||percentage of participants||95% Confidence Interval|Number
814799|NCT01091662|Secondary|Percentage of Subjects Seizure-free During the Last 4 Weeks on Eslicarbazepine Acetate Monotherapy.|Percentage of participants that were Seizure-free during the last four weeks of monotherapy were determined as subjects who had seizure assessments during the 4 weeks between Visits 8 and 9 (Weeks 15 through 18), and did not have any seizures.|Week 15 through 18|Efficacy population||percentage of participants||95% Confidence Interval|Number
814800|NCT01091662|Secondary|Proportion (%) of Subjects That Are Seizure-free During the 10-week Double-blind Monotherapy Treatment Period.|Seizure-free subjects during the monotherapy period were determined as subjects who had seizure assessments during the monotherapy period, and did not have any seizures in the 10 weeks between Visits 6 and 9 (Weeks 9 through 18). Subjects who discontinued during this period were considered not seizure-free even if they were seizure-free at the time of discontinuation, i.e., to be considered seizure-free, subjects must complete the 10-week period without any seizures.|Week 9 through 18|Efficacy population||percentage of participants||95% Confidence Interval|Number
814801|NCT01091662|Primary|Cumulative 112-day Exit Rate as Estimated by Kaplan-Meier Method|"Cumulative exit rate was defined as the proportion of subjects meeting at least one of the following five exit criteria over a 16-week study period (from start of AED taper/con. period (Wk 3) to end of double blind monotherapy period (Wk 18)).1.One episode of status epilepticus.2.One secondary gen. partial seizure (in subjects who did not have gen.seizures during 6 mo. prior to screening).3.A two fold increase in any consecutive 28 day seizure rate compared to the highest consecutive 28 day seizure rate during the 8 week baseline period. 4.A two fold increase in any consecutive 2 day seizure rate compared to the highest consecutive 2 day seizure rate during the 8 week baseline period. If the highest number of seizures in any consecutive 2 day period during the 8 week baseline was 1 then 3 seizures in a consecutive 2 day period was required to exit.
5.Worsening of seizures or increase in seizure frequency considered serious or requiring intervention as judged by the investigator"|From beginning of Week 3 to end of Week 18|Efficacy population||proportion of participants||95% Confidence Interval|Number
814802|NCT01091675|Primary|the Percentage of Patients Fulfilling the Assessment Study (ASAS) Response Criteria Were Determined|"BASDAI Bath Ankylosing Spondylitis Disease Activity Index, is the gold standard for measuring and evaluating disease activity in Ankylosing Spondylitis consists of a one through 10 scale which is used to answer 6 questions pertaining to the 5 major symptoms of AS.
BASDAI has been used to assess the efficacy of the treatment. Possible Patients were considerate respond to ASABIO criteria when presented a change of 2 in the BASDAI score range."|the ASAS response were evaluated at week 2 and 4 and after 6 months treatment|Patients with physician-diagnosed Ankylosing Spondylitis at 6 months before study start||percentage of participants||95% Confidence Interval|Number
814803|NCT01091948|Secondary|Number of Intubation Attempts||from start of intubation to successfully intubated|||participants|||Number
814804|NCT01091948|Secondary|Sore Throat Grade||On the first postoperative day|This outcome was not collected for 1 patient in each group.||participants|||Number
814805|NCT01091948|Secondary|Trace Bleeding|Trace bleeding is a binary outcome: yes or no, which is determined based on amount of post-intubation bleeding present in the suction tube|Right after intubation|||participants|||Number
814806|NCT01091948|Secondary|Occurrence of Hypoxaemia|Arterial oxygen saturation was recorded at 1 min prior to intubation, intubation, and 2, 4, 6, 8, and 10 min after; hypoxaemia was defined as occurrence of arterial oxygen saturation <90% at any of the above measurements.|at 1 min prior to intubation, intubation, and 2, 4, 6, 8, and 10 min after|||participants|||Number
814810|NCT01091974|Secondary|Fatigue Will be Assessed by the Total Score of the Revised Brief Fatigue Inventory (BFI) .|The revised Brief Fatigue Inventory (BFI) is a 9-item, patient-report instrument with established reliability and validity. The BFI allows for the rapid assessment of fatigue level in cancer patients and identifies those patients with severe fatigue. Three items ask patients to rate their fatigue “now,” and fatigue at its “worst” and “usual” for the last 24 hours. The 11-point scales are bounded by 0 = “no fatigue” and 10 = “fatigue as bad as you can imagine.” Using the same type of scales, the remaining questions ask patients to rate how their fatigue interferes with several functional domains, including general activity, walking, mood, work, and relations with others. These scales are bounded by 0 = “does not interfere” and 10 = “interferes completely.” A global fatigue score (ranging from 0-10) can be obtained by averaging all the items on the BFI.|ANCOVA was employed with multiple imputation on the post-intervention score (average of the two post-intervention weeks), controlling for the score at the time of consent (pre).|Note: One patient randomized to the placebo only condition failed to provide data and was not included in the analyses.||units on a scale||Standard Error|Mean
814811|NCT01091974|Primary|Change in Insomnia Severity Index From Baseline to Post-intervention|The Insomnia Severity Index (ISI) is a commonly used, 7-item psychometrically validated measure used to rate insomnia with 0-7 = absence of insomnia, 8-14 = subthreshold insomnia symptoms, 15-21 = moderate insomnia, and 22-28 = severe insomnia.|ANCOVA was employed with multiple imputation on the post-intervention score (average of the two post-intervention weeks), controlling for the score at the time of consent (pre).|||units on a scale||Standard Error|Mean
814812|NCT01092338|Primary|Efficacy of the Two Doses (4000 and 7000 IU/d)|Daily D3 supplementation will result in 25D >= to 32/ng/ml|12 weeks|Number of subjects with serum 25D concentration levels >= 32 ng/ml after 12 weeks of supplementation.||participants|||Number
814813|NCT01092338|Primary|Safety|Determined by incidence of elevated serum calcium (above age specific range) associated with elevated serum 25D concentrations (>160ng/ml).|12 weeks|Number of subjects with elevated serum calcium (above age specific range) associated with elevated serum 25D concentrations (>160ng/ml)||participants|||Number
814814|NCT01084707|Primary|Average Concentration|Pharmacokinetic measurement - average concentration during the last dosing interval (AUCtau)|During the last dosing interval (hour 11-12 post-dose)|ITT||(ng/ml)||Standard Deviation|Geometric Mean
814815|NCT01084707|Secondary|Nicotine Plasma Concentration|The nicotine concentration in plasma (area under the nicotine plasma concentration curve) 1 hour after start of treatment|One hour after start of treatment|ITT||(ng/ml)||Standard Deviation|Geometric Mean
814816|NCT01084707|Secondary|Peak-Trough Fluctuation|Percent of peak-trough fluctuation over one dosing interval at steady state (PTF)|During the last dosing interval (hour 11-12 post-dose)|ITT||Percent Fluctuation||Standard Deviation|Mean
814817|NCT01084707|Secondary|Minimum Plasma Concentration|The minimum nicotine plasma concentration during the last dosing interval (Cmin)|During the last dosing interval (hour 11-12 post-dose)|ITT||(ng/ml)||Standard Deviation|Mean
814818|NCT01084707|Secondary|Time of Maximum Concentration|The time at which maximum concentration is reached (Tmax)|During the last dosing interval (hour 11-12 post-dose)|ITT||(minutes)||Full Range|Median
814819|NCT01084707|Primary|Maximum Plasma Concentration|Cmax, which is the maximum (peak) concentration (amount of drug) measurable in blood plasma after a dose is administered measured in nanograms/milliliter (ng/ml)|During the last dosing interval (hour 11-12 post-dose)|||(ng/ml)||Standard Deviation|Geometric Mean
814820|NCT01084759|Secondary|Number of Participants With RECIST Response (i.e. Complete Response or Partial Response)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan or MRI. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|2 years|||participants|||Number
814821|NCT01084759|Primary|Time to PSA Progression|Time to a PSA increase above the PSA level obtained after 3 months on testosterone treatment over two successive measurements 2 weeks apart.|2 years|||days||Full Range|Median
814822|NCT01084759|Primary|Percentage of Patients Completing at Least 3 Months of Therapy With a PSA Below Baseline.||3 months|||Percentage of Participants||95% Confidence Interval|Number
814823|NCT01085006|Secondary|Amount of Hemorrhage in the First 24 Hour After Cesarean Delivery||First 24 hours||||||
814824|NCT01085006|Primary|The Amount of Hemorrhage During Cesarean Delivery and Within 2 Hours Afterward||During the procedure and within 2 hours afterwards|||ml||Full Range|Median
814825|NCT01085045|Secondary|Change From BL in Mean Evening Post-dose Daily Peak Flow Rate on Day 7|Change from BaseLine in mean evening post-dose daily peak flow rate on Day 7|Day 7|MITT Population - not including the 4 sentinel patients.||Liters / Minute||95% Confidence Interval|Least Squares Mean
814826|NCT01085045|Secondary|Change From BL in Mean Evening Pre-dose Daily Peak Flow Rate on Day 7|Change from BaseLine in mean evening pre-dose daily peak flow rate on Day 7|Day 7|MITT Population - not including the 4 sentinel patients.||Liters / Minute||95% Confidence Interval|Least Squares Mean
814827|NCT01085045|Secondary|Change From BL in Mean Morning Post-dose Daily Peak Flow Rate on Day 7|Change from BaseLine in mean morning post-dose daily peak flow rate on Day 7|Day 7|MITT Population - not including the 4 sentinel patients.||Liters / Minute||95% Confidence Interval|Least Squares Mean
814828|NCT01085045|Secondary|Change From BL in Mean Morning Pre-dose Daily Peak Flow Rate on Day 7|Change from BaseLine in mean morning pre-dose daily peak flow rate on Day 7|Day 7|MITT Population - not including the 4 sentinel patients.||Liters / Minute||95% Confidence Interval|Least Squares Mean
814829|NCT01085045|Secondary|12 hr Post-dose Trough FEV1 on Day 7|12 hour post-dose trough Forced Expiratory Volume in 1 second on Day 7|Day 7|MITT Population - not including the 4 sentinel patients.||Liters||95% Confidence Interval|Least Squares Mean
814830|NCT01085045|Secondary|Change in Morning Pre-dose FEV1 on Day 7|Change from Baseline in morning pre-dose FEV1 on Day 7|Day 7|MITT Population - not including the 4 sentinel patients.||Liters||95% Confidence Interval|Least Squares Mean
814831|NCT01085045|Secondary|Percentage of Patients Achieving >=12% Improvement in FEV1 on Day 1|Time to Onset of Action where the improvement in FEV1 on Day 1 was >= 12%|Day 1|MITT Population - not including the 4 sentinel patients.||Percentage of Participants|||Number
814832|NCT01085045|Secondary|Time to Onset of Action >=10% Improvement in FEV1 on Day 1|Time to Onset of Action where the improvement in FEV1 on Day 1 was >=10%|Day 1|MITT Population - not including the 4 sentinel patients.||Participants|||Number
814838|NCT01085136|Secondary|Intensity and Incidence of Adverse Events (AEs) for Part A & Part B.|Safety of Afatinib as indicated by intensity and incidence of adverse events, graded according to United States National Cancer Institute Common terminology Criteria for Adverse Events (US NCI CTCAE) Version 3.0 both for Part A and Part B. The CTCAE grades are: 1 (mild AE), 2 (moderate AE), 3 (severe AE), 4 (life-threatening or disabling AE), 5 (death related to AE).|From first administration of treatment until 28 days after last drug administration, up to 51 Months (Part A) and from randomization until 28 days after last drug administration of Trial medication, up to 32 Months (Part B)|Treated Set||Percentage of participants|||Number
814839|NCT01085136|Secondary|Objective Response (Part B)|Objective response (CR, PR) of Afatinib/paclitaxel combination therapy and comparator chemotherapy in Part B after progression in Part A according to RECIST 1.1 .|Post baseline tumour-imaging was performed at every 8 weeks thereafter until disease progression; up to 32 Months|Randomized Set||Percentage of participants||95% Confidence Interval|Number
814840|NCT01085136|Secondary|Objective Response (Part A)|Objective response defined as the best overall response of complete response [CR]: disappearance of all target lesion & partial response [PR]: ≥30% decrease in the sum of the longest diameter of target lesions , taking as reference the baseline sum longest diameter of Afatinib monotherapy according to RECIST 1.1 for Part A.|Post baseline tumour-imaging was performed at every 6 weeks thereafter until disease progression; upto 51 months|Treated set||Percentage of participants||95% Confidence Interval|Number
814841|NCT01085136|Secondary|Overall Survival (Part B)|"Overall survival (OS) as determined by the time from randomization to death in part B.
Median was calculated from the Kaplan−Meier curve."|From randomization until death; Up to 32 months|Randomised Set||Months||95% Confidence Interval|Median
814842|NCT01085136|Secondary|Progression Free Survival (Part A)|"Progression free survival (PFS) as determined by Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 for Part A.
Median was calculated from the Kaplan−Meier curve."|From first dose administration until disease progression or death; Up to 51 months|Treated set||Months||95% Confidence Interval|Median
814843|NCT01085136|Primary|Progression Free Survival (Part B)|"Progression free survival (PFS) time as determined by Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 from day of randomization until disease progression or death for patients randomised to combination therapy with afatinib plus paclitaxel or to investigator's choice of chemotherapy.
Median was calculated from the Kaplan−Meier curve."|From randomization until disease progression or death; Up to 32 months|Randomised Set: This analysis set consist of all randomised patients irrespective of whether treated or not.||Months||95% Confidence Interval|Median
814844|NCT01085201|Secondary|Pain Levels During a Vaso-occlusive Event in Children and Adults With SCD.|Pain was measured using a standardized pain scale. The scale is a 10-cm visual analogue scale (10 cm-long line printed on white paper), where 0 is no pain and 10 is maximum pain. Participants were asked to indicate their pain level by marking on the line prior to each blood draw.|pre-drug to 54 hours|The number of participants was determined per protocol following a 3+3 design. Stages 1, 2 and 2b were excluded because this outcome measure is specific to the experience of a vaso-occlusive event, which was studied in Stages 3 and 4.||units on a scale||Standard Deviation|Median
814845|NCT01085201|Secondary|Percentage of Activated iNKT Cells and/or Activation Markers on iNKT Cells in Individuals With SCD.|Percentage of activated iNKT cells after receiving a 24-hour infusion of Lexiscan was compared to pre-drug. iNKT cell activation was evaluated using antibodies targeting the p65 subunit of nuclear factor-kappa B (phospho-NF-kB p65). Measures are given as percentage of change in phospho-NF-kB p65 activation in iNKT cells compared to pre-drug after a 24-hour infusion. iNKT cell activation in Stages 1, 2b, and 4 was not analyzed (see analysis population description).|pre-drug to 54 hours|The number of subjects was determined per protocol. Stage 1 was excluded as the goal was to determine the optimal markers for iNKT cells. Only 4 subjects were analyzed in Stage 2 because 24-hour samples were not obtained for 2 subjects. Stages 2b and 4 were not completely analyzed because these stages were completed early after studying 3 subjects.||percentage of change in activation||Standard Deviation|Median
814846|NCT01085201|Primary|Dose Limiting Toxicities as a Measure of Whether Infusional Lexiscan is Safe in Individuals With SCD.|"Per protocol, Lexiscan was considered safe if well tolerated based on number of DLTs reported. Stage 1 of the study was a 3+3 dose escalation study. Three doses were tested: 0.24 mcg/kg/hr (dose level 0), 0.6 mcg/kg/hr (dose level 1), and 1.44 mcg/kg/hr (dose level 2). Dose escalation continued until 6 participants were treated at the maximum planned dose (dose level 2). We studied a total of 15 patients in Stage 1. In Stages 2 and 3, if at least 2/3 participants tolerated the dose, an additional 3 participants were studied. We studied 6 participants in each of stages 2 and 3. In stage 2b, Lexiscan was studied for a longer (48 hr) duration in 3 participants. In stage 4, Lexiscan was studied in 3 pediatric participants."|30 to 54 hours plus 30-day follow-up|The number of participants was determined per protocol following a 3+3 design. In Stages 2b and 4, we received permission from the FDA, IRB, and DSMB to study only 3 subjects because we did not observe any prior DLT. One patient enrolled in Stage 2b withdrew consent during the infusion due to an unrelated toothache, and was excluded from analysis.||number of DLT|||Number
814847|NCT01085214|Other Pre-specified|Level of Key Regulators|The level of key regulators of the MEK/MAPK and PI3K pathways and HSP90 and cell cycle regulators may determine the anti-tumor response to AZD6244 in vivo in multiple myeloma (MM).|Up to 20-30 hours after receiving the first dose of selumetinib||||||
814848|NCT01085214|Other Pre-specified|Changes in Bone Marrow Microenvironment|Effect of AZD6244 on the bone marrow microenvironment in MM.|Baseline to up to 20-30 hours after receiving the first dose of AZD6244||||||
814849|NCT01085214|Secondary|Progression Free Survival (PFS)|Median PFS in months. Progressive Disease (PD): Increase of >= 25% from baseline. Estimated using the method of Kaplan-Meier.|From registration to progression or death, assessed up to 2 years|All participants who received study treatment||months||Full Range|Median
814850|NCT01085214|Secondary|Incidence of Toxicity That May Be Treatment Emergent|Participants with Grade 3, 4, and 5 toxicities possibly, probably, or definitely related to study treatment. Toxicity graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE).|1 year, 11 months|All participants who received study treatment||participants|||Number
814851|NCT01085214|Secondary|Duration of Response|Mean duration of response in months. Estimated using the method of Kaplan-Meier.|From response to disease progression or death, assessed up to 2 years|All participants with response||months||Full Range|Mean
814856|NCT01085318|Primary|Change in Volume (in Millimeters Cubed) of Normal Appearing Brain Tissue (NABT) With Increasing (Indicative of Remyelination) Voxel-wise Magnetization Transfer Ratio (VW-MTR) From Baseline to 6 Months|To characterize the effect of Rebif on remyelination using VW-MTR dynamic mapping of NABT in subjects ith RRMS over 6 months of treatment compared to a group of healthy Control (HC).|Baseline to Month 6|The analysis were run on the Intent-to-Treat (ITT) set defined as all RRMS subjects with at least one injection of Rebif and all HC who signed the informed consent form. Missing data were not imputed.||mm^3||Full Range|Median
814857|NCT01085331|Secondary|Part 2 or Phase 2 Randomized Part: Number of Subjects With TEAEs, Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death|An AE is defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. An SAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAES between first dose of study drug administration and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|From the first dose of study drug administration up to 28 days after the last dose of study drug administration|Part 2 or Phase 2 Randomized Part of the trial was not conducted. Hence, safety outcome measure could not be performed.|||||
814858|NCT01085331|Secondary|Part 2 or Phase 2 Randomized Part: Best Overall Response|BOR was defined based on Response Evaluation Criteria In Solid Tumors Version 1.0 (RECIST V1.0) as following: Complete response (CR) was defined as the disappearance of all target and non-target lesions and no appearance of new lesions. Partial response (PR) was defined as at least a 30 percent (%) decrease in the sum of the longest diameters (SLD) of the targeted lesions. CR and PR had to be documented on 2 occasions separated by at least 4 weeks (28 days). Stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify as progressive disease (PD) being demonstrated during the first 4 weeks. PD was defined as at least a 20% increase in the SLD of target lesions compared to the smallest SLD since the study treatment started.|Up to 2 years|Part 2 or Phase 2 Randomized Part of the trial was not conducted. Hence, Best overall response was not evaluated.|||||
814859|NCT01085331|Secondary|Part 2 or Phase 2 Randomized Part: Circulating Biomarkers||Predose, Day 1, 2 and 16 of cycle 1 followed by Day 1 pre-dose of every second cycle up to 2 years|Part 2 or Phase 2 Randomized Part of the trial was not conducted. Hence, circulating biomarkers were not evaluated.|||||
814860|NCT01085331|Secondary|Part 1 or Safety Run-in Part: Circulating Biomarkers in Serum||Predose, Day 1, 2 and 16 of cycle 1 followed by Day 1 pre-dose of every second cycle up to 2 years|Number of subjects enrolled in the safety run-in part of the trial was less and it would not provide sufficient statistical power to perform any analysis. Hence, the biomarker samples were not analyzed as part of the trial.|||||
814861|NCT01085331|Secondary|Part 1 or Safety Run-in Part: Number of Subjects With Best Overall Response (BOR)|BOR was defined based on Response Evaluation Criteria in Solid Tumors Version 1.0 (RECIST V1.0) as following: Complete response (CR) was defined as the disappearance of all target and non-target lesions and no appearance of new lesions. Partial response (PR) was defined as at least a 30 percent (%) decrease in the sum of the longest diameters (SLD) of the targeted lesions. CR and PR had to be documented on 2 occasions separated by at least 4 weeks (28 days). Stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify as progressive disease (PD) being demonstrated during the first 4 weeks. PD was defined as at least a 20% increase in the SLD of target lesions compared to the smallest SLD since the study treatment started.|Up to 2 years|The efficacy analysis set included all subjects who received at least 1 trial drug dose (any of the three FOLFIRI drugs and pimasertib) and had a baseline tumor assessment and at least 1 post-baseline efficacy assessment.||Subjects|||Number
814862|NCT01085331|Secondary|Part 1 or Safety Run-in Part: Ratio of AUC0-inf of Pimasertib (Day 1/Day 8), Irinotecan and SN-38 (Day 1/Day 15)|The AUC(0-inf) was estimated by determining the total area under the concentration time curve extrapolated to infinity.|Day 1 and Day 8 for pimasertib; Day 1 and Day 15 for Irinotecan|"The PK analysis population set included all subjects who had an evaluable plasma concentration-time profile on any of the PK sampling days (Day 1 or 8 or 15). Here, N (total number of subjects analyzed) signifies number of evaluable subjects for this outcome measure. n signifies number of subjects evaluable per each category, respectively."||Ratio||Full Range|Median
814863|NCT01085331|Secondary|Part 1 or Safety Run-in Part: Ratio of Cmax for Pimasertib (Day 1/Day 8), Irinotecan and SN-38 (Day 1/Day 15)||Day 1 and Day 8 for pimasertib; Day 1 and Day 15 for Irinotecan and SN-38|"The PK analysis population set included all subjects who had an evaluable plasma concentration-time profile on any of the PK sampling days (Day 1 or 8 or 15). Here, N (total number of subjects analyzed) signifies number of evaluable subjects for this outcome measure. n signifies number of subjects evaluable per each category, respectively."||Ratio of Cmax||Full Range|Median
814864|NCT01085331|Secondary|Part 1 or Safety Run-in Part: Apparent Oral Volume of Distribution (Vz f) Pimasertib, (Vz) of Irinotecan and SN-38|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration. Apparent volume of distribution after oral dose (Vz/f) was influenced by the fraction absorbed.|Day 1 and Day 8 for pimasertib; Day 1 and Day 15 for Irinotecan and SN-38|"The PK analysis population set included all subjects who had an evaluable plasma concentration-time profile on any of the PK sampling days (Day 1 or 8 or 15). Here, N (total number of subjects analyzed) signifies number of evaluable subjects for this outcome measure. n signifies number of subjects evaluable per each category, respectively."||Liter||Full Range|Median
814865|NCT01085331|Secondary|Part 1 or Safety Run-in Part: Apparent Oral Clearance (CL/f) of Pimasertib, (CL) Irinotecan and SN-38|Clearance of a drug was a measure of the rate at which drug was metabolized or eliminated by normal biological processes. Apparent clearance after oral dose (CL/f) is influenced by the fraction absorbed.|Day 1 and Day 8 for pimasertib; Day 1 and Day 15 for Irinotecan and SN-38|"The PK analysis population set included all subjects who had an evaluable plasma concentration-time profile on any of the PK sampling days (Day 1 or 8 or 15). Here, N (total number of subjects analyzed) signifies number of evaluable subjects for this outcome measure. n signifies number of subjects evaluable per each category, respectively."||Liter per hour||Full Range|Median
816925|NCT01116882|Secondary|Complete Revascularization|Complete revascularization was defined as the successful treatment, according to the criteria of procedural success, of all epicardial vessels with more than 70% and less than 100% stenosis.|Post-Procedure|||participants|||Number
814866|NCT01085331|Secondary|Part 1 or Safety Run-in Part: Apparent Terminal Half Life (t1/2) of Pimasertib, Irinotecan and SN-38|The t1/2 was defined as the time required for the plasma concentration of pimasertib and irinotecan to decrease 50% in the final stage of elimination.|Day 1 and Day 8 for pimasertib; Day 1 and Day 15 for Irinotecan and SN-38|"The PK analysis population set included all subjects who had an evaluable plasma concentration-time profile on any of the PK sampling days (Day 1 or 8 or 15). Here, N (total number of subjects analyzed) signifies number of evaluable subjects for this outcome measure. n signifies number of subjects evaluable per each category, respectively."||hour||Full Range|Median
814867|NCT01085331|Secondary|Part 1 or Safety Run-in Part: Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of Pimasertib, Irinotecan and SN-38|The AUC(0-inf) of pimasertib and irinotecan was estimated by determining the total area under the concentration time curve extrapolated to infinity.|Day 1 and Day 8 for pimasertib; Day 1 and Day 15 for Irinotecan and SN-38|"The PK analysis population set included all subjects who had an evaluable plasma concentration-time profile on any of the PK sampling days (Day 1 or 8 or 15). Here, N (total number of subjects analyzed) signifies number of evaluable subjects for this outcome measure. n signifies number of subjects evaluable per each category, respectively."||ng/mL*hour||Full Range|Median
814868|NCT01085331|Secondary|Part 1 or Safety Run-in Part: Area Under the Concentration-time Curve From Time Zero to the Time of Last Observation (AUC0-t) of Pimasertib, Irinotecan and SN-38|Area under the plasma concentration-time curve from time zero to the last sampling time (AUC0-t) at which the concentration is at or above the lower limit of quantification.|Day 1 and Day 8 for pimasertib; Day 1 and Day 15 for Irinotecan and SN-38|"The pharmacokinetic (PK) evaluation set included subjects who had an evaluable plasma concentration-time profile on any of the PK sampling days (Day 1 or 8 or 15). n signifies number of subjects evaluable in each category, respectively."||(nanogram/milliliter)*hour([ng/mL]*hour)||Full Range|Median
814869|NCT01085331|Secondary|Part 1 or Safety Run-in Part: Time to Reach Maximum Observed Concentration (Tmax) of Pimasertib, Irinotecan and SN-38||Day 1 and Day 8 for pimasertib; Day 1 and Day 15 for Irinotecan and SN-38|"The pharmacokinetic (PK) evaluation set included subjects who had an evaluable plasma concentration-time profile on any of the PK sampling days (Day 1 or 8 or 15). n signifies number of subjects evaluable in each category, respectively."||hour||Full Range|Median
814870|NCT01085331|Secondary|Part 1 or Safety Run-in Part: Maximum Observed Plasma Concentration (Cmax) of Pimasertib, Irinotecan and SN-38||Day 1 and Day 8 for pimasertib; Day 1 and Day 15 for Irinotecan and SN-38|"The pharmacokinetic (PK) evaluation set included subjects who had an evaluable plasma concentration-time profile on any of the PK sampling days (Day 1 or 8 or 15). n signifies number of subjects evaluable in each category, respectively."||nanogram per milliliter (ng/mL)||Full Range|Median
814871|NCT01085331|Secondary|Part 1 or Safety Run-in Part: Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death|An AE is defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. An SAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|From the first dose of study drug administration up to 28 days after the last dose of study drug administration|The safety analysis set included all subjects who received at least one (non-zero) administration of the trial medication (any of the 3 FOLFIRI drugs and pimasertib).||Subjects|||Number
814872|NCT01085331|Primary|Part 2 or Phase 2 Randomised Part: Progression Free Survival (PFS)|PFS was defined as time (in months) from the date of randomization to the first documentation of disease progression as reported and documented by the Investigator (i.e. radiological progression per RECIST v1.0) or death for any cause.|From randomization up to first documented disease progression maximum up to 2 years|Part 2 or Phase 2 Randomized Part of the trial was not conducted. Hence, PFS was not evaluated for this study.|||||
814873|NCT01085331|Primary|Part 1 or Safety Run-in Part: Maximum Tolerated Dose (MTD)|MTD was defined as the dose level, at which the treatment-related dose limiting toxicity (DLT) occurred in >1 of 3 subjects or in >1 of 6 subjects. DLT was defined using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Any Grade >=3 non-hematological toxicity except for Grade 4 asymptomatic increases in liver function tests (LFTs) reversible within 7 days in subjects with liver involvement, Grade 3 asymptomatic increases in LFTs reversible within 7 days in subjects without liver involvement, Grade 3 vomiting controlled with adequate and optimal therapy and prophylaxis, and Grade 3 diarrhea controlled with adequate and optimal anti-diarrhea therapy; any Grade 4 neutropenia lasing >5 days/ febrile neutropenia lasting >1 day; any Grade 4 thrombocytopenia/Grade 3 with bleeding; any treatment delay >2 weeks due to trial treatment-related adverse effects at any dose level and judged to be possibly or probably related to the trial treatment.|Baseline up to Day 28 (Part 1)|The safety analysis set included all subjects who received at least one (non-zero) administration of the trial medication (any of the 3 FOLFIRI drugs and pimasertib).||mg|||Number
814874|NCT01085357|Secondary|Proportion of Eyes With Postoperative IOP ≥ 6 and ≤ 18 mmHg, as Measured by Goldmann Tonometry, at the Hypotensive Medication-free 24-month Postoperative Examination Using Non-responder Imputation for Missing Data|IOP was assessed using Goldmann applanation tonometry and reported in mmHg. One eye (study eye) contributed to the analysis. Proportion of eyes is reported as a percentage. Non-responders include subject eyes for which, prior to the relevant outcome time point: 1) Use of ocular hypotensive medication was not terminated; 2) IOP-affecting secondary surgical procedure was performed; 3) CyPass was explanted; or 4) CyPass was repositioned. IOP-affecting secondary surgical procedures include: Iridotomy, iridectomy, trabeculectomy, glaucoma shunt implantation, argon laser trabeculoplasty, selective laser trabeculoplasty, or other surgery that would affect IOP. Subject eyes for which CyPass implantation was attempted but not completed were treated as non-responders.|Month 24 postoperative|ITT||percentage of eyes|Eyes||Number
814958|NCT01092663|Primary|Postprandial Rate of Total Glucose Disposal Area Under the Curve (AUC)|"Change from baseline in postprandial rate of total glucose disposal (AUC) after 12 weeks of colesevelam alone or colesevelam plus sitagliptin treatments
AUC was calculated by the trapezoid method using all results measured between 0 and 300 min during the meal tolerance test."|baseline and 12 weeks|||umol per kg per min||Standard Deviation|Mean
816926|NCT01116882|Secondary|Major Vascular Complications||30 days|||participants|||Number
814875|NCT01085357|Secondary|Mean Change in IOP Between Baseline and Hypotensive Medication-free 24-month Postoperative Examination Using Baseline Value Imputation for Missing Data|IOP was assessed using Goldmann applanation tonometry and reported in mmHg. A negative value indicates an improvement. One eye (study eye) contributed to the analysis. Proportion of eyes is reported as a percentage. Baseline IOP was used for subject eyes for which, prior to the relevant outcome time point: 1) Use of ocular hypotensive medication was not terminated; 2) IOP-affecting secondary surgical procedure was performed; 3) CyPass was explanted; or 4) CyPass was repositioned. IOP-affecting secondary surgical procedures include: Iridotomy, iridectomy, trabeculectomy, glaucoma shunt implantation, argon laser trabeculoplasty, selective laser trabeculoplasty, or other surgery that would affect IOP. Subject eyes for which CyPass implantation was attempted but not completed were treated as non-responders.|Baseline; Month 24 postoperative|ITT||mmHg||Standard Deviation|Mean
814876|NCT01085357|Primary|Proportion of Eyes With ≥ 20% Decrease in Intraocular Pressure (IOP) From Baseline to the Hypotensive Medication-free 24-month Postoperative Examination Using Non-responder Imputation for Missing Data|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). A reduction in IOP from baseline indicates an improvement. One eye (study eye) contributed to the analysis. Proportion of eyes is reported as a percentage. Non-responders include subject eyes for which, prior to the relevant outcome time point: 1) Use of ocular hypotensive medication was not terminated; 2) IOP-affecting secondary surgical procedure was performed; 3) CyPass was explanted; or 4) CyPass was repositioned. IOP-affecting secondary surgical procedures include: Iridotomy, iridectomy, trabeculectomy, glaucoma shunt implantation, argon laser trabeculoplasty, selective laser trabeculoplasty, or other surgery that would affect IOP. Subject eyes for which CyPass implantation was attempted but not completed were treated as non-responders.|Baseline; Month 24 postoperative|Intent-to-treat (ITT)||percentage of eyes|Eyes||Number
814877|NCT01085500|Secondary|Number of Hernia Repair Subjects With Post-Operative Urinary Retention|Urinary retention is the inability to empty the bladder. This is an educational study for surgeons. The participants in the study are surgeons, and the participant flow, baseline characteristics and first two outcome measures are for the surgeons. During the part of the study reported for the third outcome measure, the first surgical procedure (TEP) after randomization, each surgeon had one subject. Therefore, this outcome measure is for the hernia patients or subjects.|at first TEP procedure post-randomization, subjects were followed for the duration of hospital stay, an average of 1 night|||Subjects|||Number
814878|NCT01085500|Secondary|Operative Performance|The trained observer and the staff supervising surgeon graded operative performance independently using a global rating scale, Global Operative Assessment of Laparoscopic Skills (GOALS) immediately after each case, (1 rating per case if bilateral repair). The GOALS tool has been shown to be a valid and reliable tool to measure generic laparoscopic skills in the simulated environment and in the operating room, with good agreement between live and video-review ratings. The scores range from 6 to 30, a higher score indicates greater operative performance.|at first TEP procedure post-randomization; due to surgical scheduling variability this can be anytime from 1 to 2 days following randomization to a week or two|||units on a scale||Standard Deviation|Mean
814879|NCT01085500|Primary|Participation-Corrected Operative Time|Operative time was recorded with a standard stopwatch, began at the start of the operative case and ended when procedure was terminated. We realized that the operative time for poorly performing trainees could be faster than the time for more skilled trainees because the supervising surgeon would perform a greater proportion of the procedure. We calculated participation-corrected time as raw total time + the time of staff involvement: time_corrected = time_raw + (1-participation) x time_raw.|at first TEP procedure post-randomization; Due to surgical scheduling variability this can be anytime from 1 to 2 days following randomization to a week or two|||minutes||Standard Deviation|Mean
814880|NCT01085513|Secondary|CE-EIA Scores for Dysmotility||within 7 days||||||
814881|NCT01085513|Secondary|Clinical Symptoms||within 7 days||||||
814882|NCT01085513|Secondary|Features Detected by CE-EIA: Contractile Patterns; Non Contractile Patterns - Wall and Tunnel Patterns; Luminal Content - Turbid Pattern; Endoluminal Motion; Capsule Displacement.||within 7 days||||||
814883|NCT01085513|Primary|Test Characteristics (i.e., Sensitivity, Specificity, NPV, PPV) of CE-EIA, as Compared to SB Manometry Which Will be Considered as an Imperfect Gold standard14.||within 7 days|The study was terminated without achieving the needed sample size due to very low recruitment rate. therefore, no statistical analysis has been performed. T|||||
814884|NCT01085539|Primary|Detection of Oxygen Alarms That Resulted in Clinicians Changing the Care of the Infant.|Sat Secs is an oxygen alarm with 5 settings:0,10,25,50,and 100. At each setting,using the units of seconds,it filters nusiance alarms & identifies important alarms that result in the clinicians changing the care of the infant.|4 hours|All patients with complete data||percentage of interventions|||Number
814885|NCT01085591|Primary|Number of Participants With a Clinical Response Outcome of Failure or Unable to Evaluate at the End of Study Treatment|The number of participants with investigator assessed clinical response of failure or unable to evaluate is presented. Clinical response was determined by the participant’s condition on the second day following the last dose of study medication, unless considered a treatment failure. Treatment failures were assessed whenever they occurred and were carried forward to the end-of-treatment (EOT). The information to assess clinical response was collected at any time up to and including Day 19.|Baseline (Day 0) through Study Day 19|All participants who received any amount of study drug and had a confirmed diagnosis of Clostridium difficile infection (CDI).||participants|||Number
814886|NCT01085591|Secondary|Median Time to Resolution of Diarrhea|The median time to resolution of diarrhea is presented for evaluable participants in each treatment group. The time in days from the start of treatment (time of first dose of study drug) to resolution (time of the last UBM on the day before the first of 2 consecutive days of < 4 UBMs and sustained through the second day following the last dose of study drug).|Baseline (Day 0) through Study Day 12|All participants who received any amount of study drug, had a confirmed diagnosis of Clostridium difficile infection (CDI), and who achieved resolution of their diarrhea.||Days||95% Confidence Interval|Median
814959|NCT01092663|Primary|Postprandial Endogenous Glucose Production|"Change from baseline in postprandial endogenous glucose production after 12 weeks of colesevelam alone or colesevelam plus sitagliptin treatments
Mean value was calculated using all results measured between 10 and 300 min post meal."|baseline and 12 weeks|||umol per kg per min||Standard Deviation|Mean
814887|NCT01085591|Secondary|Number of Participants With a Recurrence of Clostridium Difficile Infection at the End of Study Treatment With and Without Infection Caused by C. Difficile BI/NAP1/027 Strain at Baseline|The number of participants with and without infection caused by C. difficile BI/NAP1/027 strain as determined at baseline with a recurrence of CDI is presented along with the number of participants without a recurrence and who were unable to be evaluated. Participants with a favorable outcome at the EOT (cure) were evaluated for recurrence of CDI. If diarrheal symptoms returned, participants were asked to indicate the number of UBM they had and have an additional C. difficile toxin test. The information to assess recurrence in participants who were deemed a cure at EOT was collected at any time during the 4-week FUP. Strain at Baseline=SAB.|Study Day 10 up to Study Day 40|All participants who received any amount of study drug and had a confirmed diagnosis of Clostridium difficile infection (CDI).||participants|||Number
814888|NCT01085591|Secondary|Number of Participants With a Clinical Response Outcome at the End of Study Treatment With and Without Infection Caused by C. Difficile BI/NAP1/027 Strain at Baseline|The number of participants with investigator assessed clinical response of cure, failure or unable to evaluate is presented and shown separately for participants with and without infection caused by C. difficile BI/NAP1/027 strain as determined at baseline. Clinical response was determined by the participant’s condition on the second day following the last dose of study medication, unless considered a treatment failure. Treatment failures were assessed whenever they occurred and were carried forward to the EOT. The information to assess clinical response for infection caused by C. difficile BI/NAP1/027 strain at Baseline was collected at any time up to and including Day 12. Strain at Baseline=SAB|Baseline (Day 0) through Study Day 12|All participants who received any amount of study drug and had a confirmed diagnosis of Clostridium difficile infection (CDI).||participants|||Number
814889|NCT01085591|Secondary|Number of Participants With a Recurrence of Clostridium Difficile Infection Through the 4-week Follow-up Period|The number of participants with a recurrence of CDI is presented along with the number of participants without a recurrence and who were unable to be evaluated. Participants with a favorable outcome at the EOT (cure) were evaluated for recurrence of CDI. Only subjects deemed a cure at EOT were assessed for recurrence. This is the denominator used for all percentages. If diarrheal symptoms returned, participants were asked to indicate the number of unformed bowel movements (UBM) they had and have an additional C. difficile toxin test. The information to assess recurrence in participants who were deemed a cure at EOT was collected at any time during the 4-week Follow-up Period (FUP).|Study Day 10 up to Study Day 40|All participants who received any amount of study drug and had a confirmed diagnosis of Clostridium difficile infection (CDI).||Participants|||Number
814890|NCT01085591|Primary|Number of Participants With a Clinical Response Outcome of Clostridium Difficile Infection Cure at the End of Study Treatment|The number of participants with an Investigator-assessed clinical response of cure is presented. The information to assess clinical response was collected at any time up to and including Day 19.|Baseline (Day 0) through Study Day 19|All participants who received any amount of study drug and had a confirmed diagnosis of Clostridium difficile infection (CDI).||participants|||Number
814891|NCT01085643|Secondary|A Change in Length of Spread of Retrograde Contractions After Lubiprostone|Pressure waves are considered to represent contractions if the rise in intraluminal pressure is >10mmHg above the baseline. They are considered propagating if they are recorded in more than one channel and occur within a time frame that allowed a minimal velocity of 0.7cm/sec and maximum velocity of 4cm/sec. All contractions, their direction (antegrade, stationary or retrograde) and the length of spread will be determined for each sequence at baseline (after taking Lubiprostone)and within the following 3 hours.|baseline and within the following 3 hours|Considering the fact that this is a pilot study, per protocol a total of 20 subjects should have been recruited; however, due to the limited time and complexity of the study, only 4 subjects completed the study. Due to that fact an analysis of the outcome measures was not submitted, since the results will not provide a meaningful data.||cm||Standard Deviation|Mean
814892|NCT01085643|Secondary|A Change in Length of Spread of Long Distance Propagating Contractions After Lubiprostone|Pressure waves are considered to represent contractions if the rise in intraluminal pressure is >10mmHg above the baseline. They are considered propagating if they are recorded in more than one channel and occur within a time frame that allowed a minimal velocity of 0.7cm/sec and maximum velocity of 4cm/sec. All contractions, their direction (antegrade, stationary or retrograde) and the length of spread will be determined for each sequence at baseline (after taking Lubiprostone)and within the following 3 hours.|baseline and within the following 3 hours|Considering the fact that this is a pilot study, per protocol a total of 20 subjects should have been recruited; however, due to the limited time and complexity of the study, only 4 subjects completed the study. Due to that fact an analysis of the outcome measures was not submitted, since the results will not provide a meaningful data.||cm||Standard Deviation|Mean
814893|NCT01085643|Primary|A Change in Length of Spread of Antegrade Contractions After Lubiprostone|Pressure waves are considered to represent contractions if the rise in intraluminal pressure is >10mmHg above the baseline. They are considered propagating if they are recorded in more than one channel and occur within a time frame that allowed a minimal velocity of 0.7cm/sec and maximum velocity of 4cm/sec. All contractions, their direction (antegrade, stationary or retrograde) and the length of spread will be determined for each sequence at baseline (after taking Placebo)and within the following 3 hours.|baseline and within the following 3 hours|Considering the fact that this is a pilot study, per protocol a total of 20 subjects should have been recruited; however, due to the limited time and complexity of the study, only 4 subjects completed the study. Due to that fact an analysis of the outcome measures was not submitted, since the results will not provide a meaningful data.||cm||Standard Deviation|Mean
814894|NCT01085643|Secondary|A Change in Length of Spread of Retrograde Contractions After Placebo|Pressure waves are considered to represent contractions if the rise in intraluminal pressure is >10mmHg above the baseline. They are considered propagating if they are recorded in more than one channel and occur within a time frame that allowed a minimal velocity of 0.7cm/sec and maximum velocity of 4cm/sec. All contractions, their direction (antegrade, stationary or retrograde) and the length of spread will be determined for each sequence at baseline (after taking Placebo)and within the following 3 hours.|baseline and within the following 3 hours|Considering the fact that this is a pilot study, per protocol a total of 20 subjects should have been recruited; however, due to the limited time and complexity of the study, only 4 subjects completed the study. Due to that fact an analysis of the outcome measures was not submitted, since the results will not provide a meaningful data.||cm||Standard Deviation|Mean
814895|NCT01085643|Primary|A Change in Length of Spread of Antegrade Contractions After Placebo.|Pressure waves are considered to represent contractions if the rise in intraluminal pressure is >10mmHg above the baseline. They are considered propagating if they are recorded in more than one channel and occur within a time frame that allowed a minimal velocity of 0.7cm/sec and maximum velocity of 4cm/sec. All contractions, their direction (antegrade, stationary or retrograde) and the length of spread will be determined for each sequence at baseline (after taking Placebo)and within the following 3 hours.|baseline and within the following 3 hours|Considering the fact that this is a pilot study, per protocol a total of 20 subjects should have been recruited; however, due to the limited time and complexity of the study, only 4 subjects completed the study. Due to that fact an analysis of the outcome measures was not submitted, since the results will not provide a meaningful data.||cm||Standard Deviation|Mean
814896|NCT01085643|Secondary|A Change in Length of Spread of Long Distance Propagating Contractions After Placebo.|Pressure waves are considered to represent contractions if the rise in intraluminal pressure is >10mmHg above the baseline. They are considered propagating if they are recorded in more than one channel and occur within a time frame that allowed a minimal velocity of 0.7cm/sec and maximum velocity of 4cm/sec. All contractions, their direction (antegrade, stationary or retrograde) and the length of spread will be determined for each sequence at baseline (after taking Placebo)and within the following 3 hours.|baseline and within the following 3 hours|Considering the fact that this is a pilot study, per protocol a total of 20 subjects should have been recruited; however, due to the limited time and complexity of the study, only 4 subjects completed the study. Due to that fact an analysis of the outcome measures was not submitted, since the results will not provide a meaningful data.||cm||Standard Deviation|Mean
814897|NCT01085682|Primary|Incidence of Type 2 Diabetes Mellitus|Incidence of type 2 diabetes mellitus|one year follow up|||participants|||Number
814898|NCT01085734|Secondary|Change in Macular Thickness and Macular Volume|OCT central subfield thickness measured in microns|6 months|||microns||Standard Deviation|Mean
814899|NCT01085734|Secondary|Number of Injections Needed|number of Avastin and Ozurdex injections needed|baseline to 6 months|||injections|||Number
814900|NCT01085734|Primary|Change From Baseline Visual Acuity at 6 Months|Visual Acuity was measured with ETDRS visual acuity test. Unit of measure is based on the ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.|6 months|||ETDRS score||Standard Deviation|Mean
814901|NCT01085760|Secondary|Change From Baseline in C-Reactive Protein Following 12 Weeks of Treatment||baseline, 12 weeks|Per protocol analysis done||mg/L||Full Range|Median
814902|NCT01085760|Secondary|Change From Baseline in Mayo PSC Risk Score Following 12 Weeks of Treatment|The Mayo PSC risk score was calculated for each patient at baseline and at 12 weeks, where Risk = 0.03 (age [years]) + 0.54 Ln (total bilirubin [mg/dL]) + 0.54 Ln (AST [IU/L]) + 1.24 (variceal bleeding) – 0.84 (albumin [g/dL]). There is no range, minimum, or maximum value but greater values indicate worse disease.|baseline, 12 weeks|Per protocol analysis||units on a scale||Full Range|Median
814903|NCT01085760|Secondary|Change From Baseline in Total Bilirubin Following 12 Weeks Treatment||baseline, 12 weeks|Per protocol analysis done||mg/dl||Full Range|Median
814904|NCT01085760|Primary|Change From Baseline in Alkaline Phosphatase Following 12 Weeks of Treatment||baseline, 12 weeks|The number of participants was based on a per protocol analysis.||U/L||Full Range|Median
814905|NCT01085786|Secondary|Compliance Rate|Good compliance is defined as taking equal or more than 90% of eradication medicines|Dec 2010||||||
814906|NCT01085786|Secondary|Adverse Events|by standardized questionnaire|Dec 2010||||||
814907|NCT01085786|Primary|Number of Participants in Which H. Pylori Was Eradicated|evaluate eradication outcome by endoscopy with urease test or urea breath test|Dec 2010|||participants||95% Confidence Interval|Number
814908|NCT01085825|Primary|Accurate Confirmation of Completed Abortion|Accurate confirmation of completed abortion, as determined by urine pregnancy test at following, appropriately falling serum hCG levels, or patient report of returned menses|2 weeks - 6 months|||participants|||Number
814909|NCT01085903|Secondary|Time to Swallow Puree Food|This is a behavioral measure of swallowing - the time it takes for pureed food to transition across a part of the throat. The difference score is calculated as CPS - placebo and as modafinil - placebo (for stroke subjects only).|baseline and after three days of intervention|||seconds||Standard Deviation|Mean
814910|NCT01085903|Secondary|Power Function Exponent for Oral Bolus Estimation|This is a behavioral measure of sensation in the oral cavity. The power function exponent is equal to the slope of a regression equation relating bolus size to a person's estimate of that size. An exponent below one implies an underestimate of bolus size. The difference score is calculated as CPS - baseline and as modafinil - placebo (stroke subjects only).|baseline and after three days of intervention|||exponent||Standard Deviation|Mean
814911|NCT01085903|Secondary|PVT Fastest 10 Percent of Reaction Times|This is a behavioral measure of arousal - the fastest 10 percent of all cued reaction time trials. The difference score is calculated as CPS - baseline and as modafinil - placebo (stroke subjects only).|baseline and after three days of intervention|||milliseconds||Standard Deviation|Mean
814912|NCT01085903|Primary|P50 Percent Habituation Score|This is an electrophysiological measure of arousal - a percent change in the P50 evoked response potential amplitudes with a 250 ms inter stimulus interval. The difference score is calculated as CPS - baseline and as modafinil - placebo (stroke subjects only).|baseline and after three days of intervention|||percentage of change in amplitude||Standard Deviation|Mean
814913|NCT01085968|Secondary|Symbol Digit Modality Test (SDMT)|"Symbol Digit Modality Test (SDMT): Participants are given a key of numbers (1-9) corresponding to symbols for reference.
Task: Participants are given a page of symbols and are instructed to say aloud the number corresponding to each symbol on the page.
This task is timed for completion and the score is reported as the number of symbol to number matching correct in 90 seconds."|time of enrollment and 2 months following enrollment (before and after training)|||Number of Correct Matches in 90 seconds||Standard Deviation|Mean
814914|NCT01085968|Secondary|Functional Dexterity Test (FDT)|"Functional Dexterity test (FDT): a motor dexterity measurement for hands. Task: Pick up and flip wooden pegs on a 4x4 pegboard in a zig-zag pattern; timed. Task is performed 2 times per hand Modified Task: Interchange 2 columns of of pegs (4 pegs each side) simultaneously. No flipping is required.
5 second penalty to time score for 1.) using the pegboard to help with flipping and 2.) supinating of the hand; per occurrence. 10 second penalty to time score for dropping a peg, per occurrence."|time of enrollment and 2 months following enrollment (before and after training)|||Seconds||Standard Deviation|Mean
814916|NCT01085968|Secondary|Neuropsychological Measures of Cognitive Function, Including Reaction Time and Time to Completion|"Modified Emory Functional Ambulatory Profile (mEFAP); mobility test Task 1: 5 meter walk on hard surface; timed. Task 2: 5 meter walk on carpeted surface, timed. Task 3: Timed up and go; rise from chair, walk 3 meters, walk back, sit down in chair, timed.
Task 4: Obstacle course, similar to the Timed up and go, with 2 obstacles to be stepped over while walking forward and coming back; timed.
Task 5: Ascend and descend 5 steps of stairs; timed."|time of enrollment and 2 months following enrollment (before and after training)|||Seconds||Standard Deviation|Mean
814917|NCT01085968|Primary|Reaction Time and Variability for Movement Task|Before and after computer training outcome measures: left, right, bimanual external cue reaction time; left, right, bimanual external cue error; left, right, bimanual internally generated reaction time; left, right, bimanual internally generated error for four-digit trials.|time of enrollment and 2 months following enrollment (before and after training)|PD Subjects: total number of subjects: 29, 8 withdrew from study, 2 had incomplete data. CO Subjects: total number of subjects: 25, 4 withdrew from study||milliseconds||Standard Deviation|Mean
814918|NCT01086033|Secondary|Percentage of Participants Who Missed at Least One Dose of Humira|Compliance to study treatment was measured by the percentage of participants who missed at least one dose of Humira during each time interval between study visits.|Months 3, 6, 9, 12, 18, 24, 30, and 36|"Safety population; n indicates the number of participants with available data at each time point."||percentage of participants|||Number
814919|NCT01086033|Primary|Number of Participants With an American College of Rheumatology (ACR) 70 Response|"American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:
≥ 70% improvement in tender joint count;
≥ 70% improvement in swollen joint count; and
≥ 70% improvement in at least 3 of the 5 following parameters:
Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
Patient's global assessment of disease activity (measured on a 100 mm VAS);
Physician's global assessment of disease activity (measured on a 100 mm VAS);
Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);
Acute phase reactant value (C-reactive protein [CRP])."|Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36|"Safety population; the analysis was performed on the basis of non-missing information and no imputation methods were used. n indicates the number of patients for whom ACR70 could be calculated at each time point."||participants|||Number
814920|NCT01086033|Primary|Number of Participants With an American College of Rheumatology (ACR) 50 Response|"American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:
≥ 50% improvement in tender joint count;
≥ 50% improvement in swollen joint count; and
≥ 50% improvement in at least 3 of the 5 following parameters:
Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
Patient's global assessment of disease activity (measured on a 100 mm VAS);
Physician's global assessment of disease activity (measured on a 100 mm VAS);
Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);
Acute phase reactant value (C-reactive protein [CRP])."|Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36|"Safety population; the analysis was performed on the basis of non-missing information and no imputation methods were used. n indicates the number of patients for whom ACR50 could be calculated at each time point."||participants|||Number
814921|NCT01086033|Primary|Number of Participants With an American College of Rheumatology (ACR) 20 Response|"American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:
≥ 20% improvement in tender joint count;
≥ 20% improvement in swollen joint count; and
≥ 20% improvement in at least 3 of the 5 following parameters:
Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
Patient's global assessment of disease activity (measured on a 100 mm VAS);
Physician's global assessment of disease activity (measured on a 100 mm VAS);
Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);
Acute phase reactant value (C-reactive protein [CRP])."|Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36|"Safety population; the analysis was performed on the basis of non-missing information and no imputation methods were used. n indicates the number of patients for whom ACR20 could be calculated at each time point."||participants|||Number
814922|NCT01086033|Primary|European League Against Rheumatism (EULAR) Response|"A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS28 score. The DAS28 score ranges from 0-10, with higher scores indicating more disease activity.
A Good EULAR Response is defined as an improvement (decrease) in the DAS28 of > 1.2 compared with Baseline and attainment of a DAS28 score of ≤ 3.2.
A Moderate EULAR Response is defined as either:
an improvement (decrease) in the DAS28 of > 0.6 and ≤ 1.2 from Baseline and attainment of a DAS28 score of ≤ 5.1, or
an improvement (decrease) in the DAS28 of > 1.2 from Baseline and attainment of a DAS28 score of > 3.2.
No Response is defined as either:
an improvement (decrease) in the DAS28 of ≤ to 0.6, or
an improvement (decrease) in the DAS28 of > 0.6 and ≤ 1.2 and attainment of a DAS28 of > 5.1."|Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36|Safety population;||participants|||Number
814923|NCT01086033|Primary|Disease Activity Score (DAS) 28 Over Time|The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.|Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36|"Safety population; n indicates the number of participants with available data at each time point."||units on a scale||Standard Deviation|Mean
814924|NCT01086033|Primary|Number of Participants With Adverse Events|"An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
If an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE): Results in death, is life-threatening, results in hospitalization or the prolongation of hospitalization, is a congenital anomaly or a persistent or significant disability/incapacity, is an event that results in a condition that substantially interferes with the activities of daily living of the participant, is an important medical event requiring medical or surgical intervention to prevent a serious outcome, spontaneous abortion or miscarriage experienced by the participant, or an elective abortion performed on the participant."|3 years|The safety population, including all patients that received at least one dose of the study drug.||participants|||Number
814927|NCT01086215|Primary|Change in Degree of Occlusion From Baseline to Final Angiogram/Venogram.|"From the Index Procedure's Baseline (pre-endovascular treatment) and Final (post-endovascular treatment) angiograms/venograms, each vessel was assigned a value by the treating physician.
complete occlusion (>90% occlusion);
substantial occlusion (50-90% occlusion OR <50% occlusion and >3cm in length);
partial occlusion (<50% occlusion AND <3cm in length)
patent (without visable thrombus or occlusion) The levels of change (improvement) were calculated by subtracting the baseline assigned angiographic/venographic value from the final value."|Day 1|Intention to Treat (ITT)||Units on a Scale||Standard Error|Mean
814928|NCT01092416|Primary|Primary Efficacy Endpoint: Procedural Success|Procedural success was defined as success in facilitating stent delivery with a residual stenosis of <50% and without the occurrence of an in-hospital MACE in de novo, severely calcified coronary lesions.|Participants were followed from baseline procedure through the duration of hospital stay, an average of 33.6 hours.|||Percentage of procedures||95% Confidence Interval|Number
814929|NCT01092416|Secondary|12-Month Freedom From Major Adverse Cardiac Events (MACE)|The safety of the OAS was measured for the secondary safety endpoint consisting of a composite of freedom from MACE through 12 months of follow-up.|12 months|A Kaplan-Meier analysis was performed to determine the percent probability that a study participant is free from major adverse cardiac events at 12 months.||Percent probability of Freedom from MACE||95% Confidence Interval|Number
814930|NCT01092416|Secondary|Severe Angiographic Complications|Severe angiographic complications were defined as severe dissection (Type C to F), perforation, abrupt closure, and persistent slow flow or persistent no reflow.|Baseline procedure, with a mean total procedure time of 52.5 minutes.|||Participants|||Number
814931|NCT01092416|Secondary|Angiographic Success|Angiographic success was defined as success in facilitating stent delivery with <50% residual stenosis and without severe angiographic complications.|Baseline procedure, with a mean total procedure time of 52.5 minutes.|||Percentage of procedures|||Number
814932|NCT01092416|Primary|Primary Safety Endpoint: 30-Day Freedom From Major Adverse Cardiac Events (MACE)|"OAS safety was measured by a composite of MACE at 30-days post procedure. MACE is composed of:
Cardiac death.
MI - defined as a CK-MB level > 3 times the upper limit of lab normal (ULN) value with or without new pathologic Q wave.
TVR - defined as revascularization at the target vessel (inclusive of the target lesion) after the completion of the index procedure."|30 days|A Kaplan-Meier analysis was performed to determine the percent probability that a study participant is free from major adverse cardiac events at 30 days.||Percent probability of Freedom from MACE||95% Confidence Interval|Number
814933|NCT01092442|Primary|Safety Assessment|"Evaluation of the following adverse events
Mortality (all cause and valve-related)
Reoperation/reintervention
Explant
Endocarditis
Structural valve deterioration (defined as >40 mmHg peak pulmonary gradient or >30 mmHg mean pulmonary gradient or moderately severe to severe pulmonary insufficiency)
Thrombosis
Thromboembolism (pulmonary embolism)
Non-structural dysfunction
Perivalvular leak
Bleeding
Hemolysis
Calcification"|Since Implant of the Valve to a Maximum of 13.0 years|||percentage of patients|||Number
814934|NCT01092442|Primary|Hemodynamic Performance|Pulmonary Insufficiency Grade|Most Recent Follow-up (average of 4 to 6 years post implant)|The number of participants was limited to those participants with a hemodynamic measurement provided. Therefore, the total number in each group is less than the total participants in each group.||participants|||Number
814935|NCT01092442|Primary|Hemodynamic Performance|Peak Pulmonary Gradient Mean Pulmonary Gradient|Most Recent follow-up (average of 3-6 years post implant)|The number of participants was limited to those participants with a hemodynamic measurement provided. Therefore, the total number in each group is less than the total participants in each group.||mmHg||Standard Deviation|Mean
814936|NCT01092507|Secondary|Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2 Vaccine) (CD.JEVAX®)|"Solicited Injection Site Reactions: Tenderness, Erythema, Swelling. Solicited Systemic Reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Loss, Irritability.
Grade 3 Reactions defined as: Tenderness - crying when injected limb was moved, or movement of the injected limb was reduced; Erythema and Swelling - ≥ 5 cm; Fever - temperature > 39.5ºC; Vomiting - ≥ 6 episodes per 24 hours or requiring parenteral hydration; Crying Abnormal - > 3 hours; Drowsiness - Sleeping most of the time or difficult to wake up; Appetite loss - refused ≥ 3 feeds or refused most feeds; and Irritability - inconsolable."|Day 0 through Day 14 post-vaccination|Solicited injection site and systemic reactions were assessed in all participants who received a study vaccination and for whom safety data were available, according to the vaccine actually received (Safety Population).||Participants|||Number
814937|NCT01092507|Secondary|Summary of Geometric Mean Titers of Vaccine Antibodies Before and Following One Dose of Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2; CD.JEVAX®)|Immunogenicity was assessed by JE-CV virus 50% plaque reduction neutralization test (PRNT50) or SA14-14-2 virus PRNT50.|Day 0 (pre-vaccination) and up to 12 months post-vaccination|Japanese encephalitis antibody titers were assessed in all participants that received a vaccine and with available immunogenicity data (Full Analysis Set)||Titers||95% Confidence Interval|Geometric Mean
814938|NCT01092507|Secondary|Summary of Participants With Japanese Encephalitis Seroprotection After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2, CD.JEVAX®)|"Immunogenicity was assessed by JE-CV virus 50% plaque reduction neutralization test (PRNT50) or SA14-14-2 virus PRNT50.
Japanese encephalitis seroprotection defined as participant with antibody titer ≥ 1:10 at baseline (D0) and on Day 28, Month 6, and Month 12."|Day 28 up to 12 months post-vaccination|Japanese encephalitis antibody titers were assessed in all vaccinated participants with available immunogenicity data (Full Analysis Set)||Participants|||Number
814939|NCT01092507|Secondary|Summary of Geometric Mean Titers of Vaccine Antibodies Before and Following One Dose of Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2; CD.JEVAX®)|Immunogenicity was assessed by JE-CV virus 50% plaque reduction neutralization test (PRNT50) or SA14-14-2 virus PRNT50.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Antibody titers were assessed in all participants with any immunogenicity data who did not have any protocol violations that might have interfered with primary criteria evaluation (Per-Protocol Population)||Titers||95% Confidence Interval|Geometric Mean
814940|NCT01092507|Secondary|Number of Participants With Seroconversion After Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2) (CD.JEVAX®)|"Immunogenicity was assessed by JE-CV virus 50% plaque reduction neutralization test (PRNT50) or SA14-14-2 virus PRNT50.
Seroconversion was defined as a pre-vaccination titer < 10 1/dil and post vaccination titer ≥ 10 1/dil, or a pre-vaccination titer ≥ 10 and a 4-fold increase from pre- to post-vaccination."|Day 28 post-vaccination|Antibody titers were assessed in all participants with any immunogenicity data who did not have any protocol violations that might have interfered with primary criteria evaluation (Per-Protocol Population)||Participants|||Number
814941|NCT01092507|Secondary|Number of Participants With Japanese Encephalitis Seroprotection 28 Days After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2, CD.JEVAX®)|"Immunogenicity was assessed by JE-CV virus 50% plaque reduction neutralization test (PRNT50) or SA14-14-2 virus PRNT50.
Japanese encephalitis seroprotection defined as participant with antibody titer ≥ 1:10 at baseline (D0) and on Day 28, Month 6, and Month 12."|Day 28 post-vaccination|Japanese encephalitis antibody titers were assessed in all participants with any immunogenicity data who did not have any protocol violations that might have interfered with primary criteria evaluation (Per-Protocol Population)||Participants|||Number
814942|NCT01092507|Primary|Number of Participants With Japanese Encephalitis Seroconversion After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2) (CD.JEVAX®)|"Immunogenicity was assessed by the JE-CV virus and the SA14-14-2 virus 50% plaque reduction neutralization test (PRNT50).
Japanese Encephalitis seroconversion was defined as a pre-vaccination titer <10 1/dil and post-vaccination titer ≥ 10 1/dil; or a pre-vaccination titer ≥ 10 1/dil and a 4-fold increase from pre- to post-vaccination."|Day 0 through Day 28 after vaccination|Japanese encephalitis antibody titers were assessed in all participants with immunogenicity data and who did not have any protocol violations that might have interfered with primary criteria evaluation (Per-Protocol Population)||Participants|||Number
814943|NCT01092546|Secondary|"Standard Uptake Value Ratio (SUVR) at the Site of the Biopsy Based on the Pons as the Reference Region."|The level of association between SUVR and the quantitative estimates (area percents) of amyloid levels for the following regions: Biopsy site and Contralateral and Composite Regions.|Post flutemetamol administration|"The correlation coefficient listed in the table is between SUVR-Pons and the percent area of Amyloid.
Stain IHC 4G8 was used as the Standard of Truth. Standard Uptake Value Ratio (SUVR) at the site of the biopsy was based on the Pons as the reference region."||Correlation Coefficient of the site|||Number
814944|NCT01092546|Primary|"Standard Uptake Value Ratio (SUVR) at the Site of the Biopsy Based on the Cerebellum (CER) as the Reference Region."|The level of association between the quantitative estimates of brain uptake of [18F]flutemetamol and the quantitative immunohistochemical estimates of amyloid levels in biopsy samples obtained during shunt placement in patients who have Normal Pressure Hydrocephalus (NPH). The quantitative estimates of brain uptake of [18F]flutemetamol (SUVR) will be made from the analysis of PET images.|Post flutemetamol Injection|"The correlation coefficient listed in the table is between SUVR-CER and the percent area of Amyloid.
Stain IHC 4G8 was used as the Standard of Truth. Standard Uptake Value Ratio (SUVR) at the site of the biopsy was based on the cerebullum (CER) as the reference region."||Correlation Coefficient of the Site|||Number
814945|NCT01092559|Primary|Adequacy of Device Design and Suitability of the Instructions for Use by the Clinician Using a Device Performance Evaluation||through Treatment Period|||participants|||Number
814946|NCT01092559|Primary|Incidence and Severity of Treatment Emergent Adverse Events; Unanticipated Adverse Device Effects and Changes From Baseline to End-of-study in Clinical Lab Parameters and Vital Signs.|"Adverse Event Severity [through Day 30 Follow-Up Period]
Unanticipated Device Effects: any system malfunction, damage or NO2 threshold monitor alarms [through discharge from Treatment Period]
Laboratory Tests: Hematology (CBC with differential), Chemistry (glucose, BUN, creatinine, sodium, potassium, carbon dioxide, creatinine kinase), Activated Clotting Test or Prothrombin Time, arterial blood gas, and methemoglobin.
[through discharge from Treatment Period]
Vital Signs: pulse, blood pressure, respiratory rate [through discharge from Treatment Period]"|through Day 30 Follow-up Period|||participants|||Number
814947|NCT01092637|Secondary|Number of Survivors With Cerebral Palsy|Number of participants diagnosed with Cerebral Palsy|7 years 3 months|Number of participants with cerebral palsy||participants|||Number
814948|NCT01092637|Secondary|Number of Survivors Without Disability|IQ =>85, no neurological abnormalities, normal hearing, normal vision|7 years 3 months|Number of participants without disability. Two particpants in the cooled group and three in the non-cooled group could not be classified.||participants|||Number
814949|NCT01092637|Primary|Number of Survivors With an IQ > 84|IQ was measured using WPPSI III core tests|7 years 3 months|Children for whom IQ data at age 6-7 yr were available||participants|||Number
814950|NCT01092663|Secondary|Postprandial Glucagon (AUC)|To evaluate the effects of treatment on postprandial glucagon (AUC)|Baseline and 12 weeks|||picograms (pg)/milliter (ml) x min||Standard Deviation|Mean
814951|NCT01092663|Secondary|Postprandial Total GIP (AUC)|To evaluate the effects of treatment on postprandial total GIP (AUC)|Baseline and 12 weeks|||pmol/l x min||Standard Deviation|Mean
814952|NCT01092663|Secondary|Postprandial Active GLP-1 (AUC)|To evaluate the effects of treatments on postprandial active GLP-1 (AUC)|Baseline and 12 weeks|||pmol/l x min||Standard Deviation|Mean
814953|NCT01092663|Secondary|Postprandial C-peptide (AUC)|To evaluate the effect of treatments on postprandial C-peptide (AUC)|Baseline and 12 weeks|||pmol/l x min||Standard Deviation|Mean
814954|NCT01092663|Secondary|Postprandial Insulin (AUC)|To evaluate the effect of treatments on postprandial insulin (AUC)|Baseline and 12 weeks|||pmol/l x min||Standard Deviation|Mean
814955|NCT01092663|Secondary|Fasting Insulin|To evaluate the effect of treatments on fasting insulin concentrations|Baseline and 12 weeks|||pmol/L||Standard Deviation|Mean
814956|NCT01092663|Primary|Postprandial Glucose (AUC)|Comparison between baseline and 12 weeks values of postrandial glucose (AUC).|Baseline and 12 weeks|||millimoles (mmol)/l x min||Standard Deviation|Mean
814957|NCT01092663|Primary|Whole-body Glycolytic Disposal of Oral Glucose|Change in baseline in whole-body glycolytic disposal of oral glucose after 12 weeks of colesevelam alone or colesevelam plus glucose treatments|baseline and 12 weeks|||Percent of Load||Standard Deviation|Mean
814971|NCT01092702|Primary|Biochemically Confirmed Abstinence From Smoking|The primary endpoint of this trial is biochemically confirmed 7-day point prevalence smoking abstinence at the end of the medication phase (week 12). Self-reported abstinence from smoking (not even a puff) over the last 7-days will be considered biochemically confirmed by an expired air CO of <8 ppm. Subjects who discontinue the study or have a missed visit for any reason will be classified as smoking for that visit.|12 weeks from start of medication|||participants|||Number
814972|NCT01095094|Secondary|Grade 3-5 Toxicity as Assessed by NCI CTC v3.0|Number of participants with adverse events grades 3-5. For a detailed list of adverse events see the adverse event module.|at 6 months from start of treatment|||participants|||Number
814973|NCT01095094|Primary|Progression-free Survival|Number of patients that remained disease free at 6 months from start of treatment.|At 6 months|||participants|||Number
814974|NCT01095250|Secondary|Change in Immunosuppressive Medication Score From Baseline to Week 28|No patients of Study CAIN457C2303 achieved the milestone of the primary endpoint in non-infectious uveitis patients with Behçet’s disease. Study CAIN457C2302 (active uveitis study) was terminated to avoid continuing patients on a study with a low probability of success.Since patients did not reach the endpoint of analysis there can be no meaningful interpretation of data and data will be not provided.|baseline to 28 weeks||||||
814975|NCT01095250|Secondary|Mean Change in Vitreous Haze Grade and Anterior Chamber Cell Grade From Baseline to 28 Weeks|No patients of Study CAIN457C2303 achieved the milestone of the primary endpoint in non-infectious uveitis patients with Behçet’s disease. Study CAIN457C2302 (active uveitis study) was terminated to avoid continuing patients on a study with a low probability of success.Since patients did not reach the endpoint of analysis there can be no meaningful interpretation of data and data will be not provided.|baseline to 28 weeks||||||
814976|NCT01095250|Secondary|Change From Baseline in Quality of Life/Patient Reported Outcome Assessments|No patients of Study CAIN457C2303 achieved the milestone of the primary endpoint in non-infectious uveitis patients with Behçet’s disease. Study CAIN457C2302 (active uveitis study) was terminated to avoid continuing patients on a study with a low probability of success.Since patients did not reach the endpoint of analysis there can be no meaningful interpretation of data and data will be not provided.|baseline to 28 weeks||||||
814977|NCT01095250|Secondary|Mean Change in Best Corrected Visual Acuity From Baseline to 28 Weeks|No patients of Study CAIN457C2303 achieved the milestone of the primary endpoint in non-infectious uveitis patients with Behçet’s disease. Study CAIN457C2302 (active uveitis study) was terminated to avoid continuing patients on a study with a low probability of success.Since patients did not reach the endpoint of analysis there can be no meaningful interpretation of data and data will be not provided.|baseline to 28 weeks||||||
814978|NCT01095250|Secondary|Proportion of Responders With no Recurrence of Active Intermediate, Posterior, or Panuveitis in the Study Eye at 28 Weeks|No patients of Study CAIN457C2303 achieved the milestone of the primary endpoint in non-infectious uveitis patients with Behçet’s disease. Study CAIN457C2302 (active uveitis study) was terminated to avoid continuing patients on a study with a low probability of success.Since patients did not reach the endpoint of analysis there can be no meaningful interpretation of data and data will be not provided.|baseline to 28 weeks||||||
814979|NCT01095250|Primary|Mean Change in Vitreous Haze Grade in the Study Eye From Baseline to 28 Weeks or at Time of Rescue, if Earlier.|No patients of Study CAIN457C2303 achieved the milestone of the primary endpoint in non-infectious uveitis patients with Behçet’s disease. Study CAIN457C2302 (active uveitis study) was terminated to avoid continuing patients on a study with a low probability of success.Since patients did not reach the endpoint of analysis there can be no meaningful interpretation of data and data will be not provided.|baseline to 28 weeks|The results of Study CAIN457C2303 did not meet the primary endpoint in non-infectious uveitis patients with Behçet’s disease. Study CAIN457C2302 (active uveitis study) was terminated to avoid continuing patients on a study with a low probability of success.|||||
814980|NCT01095497|Secondary|Number of Subjects With C1INH Antibodies||18 days in each treatment period||||||
814981|NCT01095497|Secondary|C1 Inhibitor (C1INH) and C4 Levels||18 days in each treatment period||||||
814982|NCT01095497|Primary|Incidence and Severity of Adverse Events, Number of Subjects With Local Injection Site Reactions, and Number of Subjects Who Discontinue Study Drug or Withdraw From the Study.||18 days in each treatment period|||Participants|||Number
814983|NCT01095510|Secondary|Change in C1 Inhibitor (C1 INH) Antigen and Functional C1 INH Concentrations|Data was not reported due to change in planned analysis.|Pre-dose, 2, 4, 8 hours post dose on Day 1; Day 2, 3, 5, 8|No participant agreed to obtain pharmacokinetic (PK) blood sampling for antigenic and functional C1 INH levels. Hence, it was planned not to be analyzed.|||||
814984|NCT01095510|Secondary|Time to Complete Resolution of the Attack||Within 1 week following treatment|ITT-E population.||hours||Full Range|Median
814985|NCT01095510|Secondary|Time to Unequivocal Beginning of Relief of the Defining Attack Symptom||Within 4 hours following treatment|ITT-E population||hours||Full Range|Median
814986|NCT01095510|Primary|Presence of Unequivocal Beginning of Relief of the Defining Attack Symptom||Within 4 hours following treatment|Intent-to-treat efficacy (ITT-E) population included all participants with baseline and at least one post-infusion investigator assessment of the hereditary angioedema (HAE) attack.||participants|||Number
814987|NCT01095653|Secondary|Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Percent adjusted for baseline HbA1c. Therapeutic glycemic response is defined as HbA1c <7.0%. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin. Mean and standard error for percentage of participants were estimated by modified logistic regression model.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing values at baseline and Week 24 (LOCF)||Percentage of participants||Standard Error|Mean
815011|NCT01095835|Secondary|Percentage of Participants With Lamivudine Genotype Resistance During PEG-IFN+LAM96 Combined Therapy|Lamivudine resistance mutations were assessed by detection of the following mutations: rtL80V, rtL80I, rtV173G, rtV173L, rtL180M, rtA181T, rtA181V, rtM204V, rtM204I and rtN236T.|At the end of the treatment period at Week 96|The ITT population for arm PEG-IFN+LAM96 included all participants randomized to PEG-IFN+LAM96 who received at least one dose of study medication.||percentage of participants|||Number
814988|NCT01095653|Secondary|Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 8, 12, 16, 20, and 24 of the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing body weight values at baseline and Week 24 (LOCF)||kg||Standard Error|Mean
814989|NCT01095653|Secondary|Adjusted Mean Change From Baseline in 2-hour Post Liquid Meal Glucose (PLMG) (mg/dL) at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Post Liquid Meal Glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. PLMG measurements were obtained on Day 1 and week 24 in the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing PLMG values at baseline and Week 24 (LOCF)||mg/dL||Standard Error|Mean
814990|NCT01095653|Secondary|Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Fasting plasma glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 8, 12, 16, 20, and 24 in the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing FPG values at baseline and Week 24 (LOCF)||mg/dL||Standard Error|Mean
814991|NCT01095653|Primary|Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF])|HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 8, 12, 16, 20, and 24 in the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing HbA1c values at baseline and Week 24 (LOCF)||% of hemoglobin||Standard Error|Mean
814992|NCT01095666|Secondary|Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Therapeutic glycemic response is defined as HbA1c <7.0%. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin. Percentage of participants were estimated by modified logistic regression model, adjusted for baseline HbA1c.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing HbA1C values at Week 24 (LOCF)||Percentage of Participants|||Number
814993|NCT01095666|Secondary|Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 8, 12, 16, 20, and 24 of the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing body weight values at baseline and Week 24 (LOCF)||kg||Standard Error|Mean
814994|NCT01095666|Secondary|Adjusted Mean Change From Baseline in 2-hour Post Meal Glucose (PMG) (mg/dL) at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Post Meal Glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. PMG measurements were obtained on Day 1 and week 24 in the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing PMG values at baseline and Week 24 (LOCF)||mg/dL||Standard Error|Mean
815012|NCT01095835|Secondary|Change From Baseline of Quantitative Hepatitis B Surface Antigen (HbsAg) Level at the End of Treatment||At the end of treatment at Week 48 or 96 depending on the study arm|The ITT population included all participants randomized who received at least one dose of study medication. Baseline values are included for those participants for whom a baseline value was measured. Change from baseline values includes only those participants with both a baseline value and a value for the summarized time period.||IU/mL||Standard Deviation|Mean
816927|NCT01116882|Secondary|Procedural Success|Procedural success is defined as residual stenosis of the target lesion of less than 20%|Post-Procedure|||participants|||Number
814995|NCT01095666|Secondary|Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Fasting plasma glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 8, 12, 16, 20, and 24 in the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing FPG values at baseline and Week 24 (LOCF)||mg/dL||Standard Error|Mean
814996|NCT01095666|Primary|Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF])|HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 8, 12, 16, 20, and 24 in the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing HbA1c values at baseline and Week 24 (LOCF)||% of hemoglobin||Standard Error|Mean
814997|NCT01095757|Primary|Patients Achieving >= 3 X 10^6 CD34+ Cell/Kg||Within the first 4 days following the first dose of Plerixafor|||participants|||Number
814998|NCT01095757|Secondary|Average Number of Days for Engraftment (Engraftment Defined as Absolute Neutrophil Count>500)||Within the first 4 days following the first dose of Plerixafor|||days||Standard Deviation|Mean
814999|NCT01095757|Primary|Patients Achieving Greater Than or Equal to 5 x 10^6 of CD34+ Cells/kg in a Single Day of Apheresis||Within the first 4 days following the first dose of Plerixafor|||participants|||Number
815000|NCT01095796|Secondary|The Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48||Week 48|ITT Analysis Set. The missing = failure (M = F) method was used in which all missing data were considered as failure (HIV-1 RNA ≥ 50 copies/mL).||percentage of participants|||Number
815001|NCT01095796|Secondary|The Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Weeks 48, 96, 144, and 192|Change = value of the relevant time point minus the baseline value|Baseline; Weeks 48, 96, 144, and 192|ITT Analysis Set. The missing = excluded (M = E) method was used in which all participants with missing data were excluded from analysis.||cells/µL||Standard Deviation|Mean
815002|NCT01095796|Secondary|The Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 50 Copies/mL at Week 48 Using the FDA-defined Time to Loss of Virologic Response (TLOVR) Algorithm||Week 48|ITT Analysis Set||percentage of participants|||Number
815003|NCT01095796|Secondary|The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 192||Week 192|Week 192 Modified Intent-to-treat (MITT) Analysis Set: Participants in the ITT analysis set, excluding those who either 1) transferred to other Gilead-sponsored studies after completing their Week 144 Visit and before the lower limit of the Week 192 analysis window, or 2) prematurely discontinued study drug prior to the Week 144 Visit.||percentage of participants|||Number
815004|NCT01095796|Secondary|The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 144||Week 144|ITT Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug||percentage of participants|||Number
815005|NCT01095796|Secondary|The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 96||Week 96|ITT Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug||percentage of participants|||Number
815006|NCT01095796|Primary|The Percentage of Participants With Virologic Success Using the Food and Drug Administration (FDA)-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 Ribonucleic Acid (RNA) < 50 Copies/mL at Week 48||Week 48|Intent-to-treat (ITT) Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug||percentage of participants|||Number
815007|NCT01095835|Other Pre-specified|Percentage of Participants With Loss of Hepatitis B Surface Antigen (HbsAg) and Hepatitis B Surface Antibodies (Anti-HBs) Seroconversion|This outcome measure presents percentage of participants with a combined response of HBsAg < 5 IU/mL and anti-HBs positive. Positive anti-HBs represents antibodies produced against Hepatitis B Surface Antigen (HBsAg) and is an indication of recovery and immunity from HBV infection.|At end of treatment at Week 48 or 96 depending on the study arm, at the end of 24 weeks of follow-up at Week 120 and at the end of the follow-up period at Week 144|The ITT population included all participants randomized who received at least one dose of study medication.||percentage of participants|||Number
815008|NCT01095835|Other Pre-specified|Percentage of Participants With HBV-DNA Below Limit of Quantification|HBV-DNA limit < 6 IU/mL was defined as below quantification.|At end of treatment at Week 48 or 96 depending on the study arm, at the end of 24 weeks of follow-up at Week 120 and at the end of the follow-up period at Week 144|The ITT population included all participants randomized who received at least one dose of study medication.||percentage of participants|||Number
815009|NCT01095835|Other Pre-specified|Percentage of Participants With HBV-DNA Lowering to <3,400 IU/mL and to < 2,000 IU/mL||At end of treatment at Week 48 or 96 depending on the study arm, at the end of 24 weeks of follow-up at Week 120 and at the end of the follow-up period at Week 144|The ITT population included all participants randomized who received at least one dose of study medication.||percentage of participants|||Number
815010|NCT01095835|Other Pre-specified|Percentage of Participants With ALT Normalization||At end of treatment at Week 48 or 96 depending on the study arm, at the end of 24 weeks of follow-up at Week 120 and at the end of the follow-up period at Week 144|The ITT population included all participants randomized who received at least one dose of study medication.||percentage of participants|||Number
816928|NCT01116882|Secondary|Emergency or Urgent Revascularization||30 days|The denominator for emergency or urgent revascularization at 30 days is defined as patients who either had the event to 30d or had follow up of at least 23 days.||participants|||Number
815013|NCT01095835|Secondary|Percentage of Participants Achieving Histological Response|Histological response was defined as an improvement by >/= 2 in the Necroinflammatory Grading and/or by an improvement by >/= 1 score in Fibrosis Staging according to Ishak. Necroinflammatory Grading ranges 0-14 and is the combined score for necrosis, range 0-10 and inflammation, range 0-4. The participant is scored for only one inflammatory condition. A higher score indicates worse condition. Fibrosis Staging according to Ishak ranges 0-6 and a higher score indicates greater fibrosis.|At the end of the 48-week follow-up period at Week 144|The ITT population included all participants randomized who received at least one dose of study medication.||percentage of participants|||Number
815014|NCT01095835|Secondary|Percentage of Participants Achieving Combined Response Using a Cut-Off for HBV-DNA Levels to 2,000 IU/mL|Combined response was defined here as ALT normalization plus lowering HBV-DNA levels to a cutt-off <2,000 IU/mL. In case of missing end of treatment measurements, the next available post-treatment value was used. In case of missing week-24 post-treatment measurements, the nearest value with respect to the schedule time point in the time window 12 weeks post treatment until study end was used. Participants with missing 48 weeks follow-up measurements were considered as non-responders. However, if the scheduled 48-weeks post-treatment tests were performed earlier or later than 48 weeks post-treatment, but not earlier than 36 weeks post-treatment, the corresponding results were considered to determine response.|At end of treatment at Week 48 or 96 depending on the study arm, at the end of 24 weeks of follow-up at Week 120 and at the end of the follow-up period at Week 144|The ITT population included all participants randomized who received at least one dose of study medication.||percentage of participants|||Number
815015|NCT01095835|Secondary|Percentage of Participants Achieving the Combined Response at 24 Weeks of Follow-up|Combined response was defined as ALT normalization plus lowering of HBV-DNA levels to <20,000 copies/mL (<3,400 IU/mL). In case of missing week-24 post-treatment measurements, the nearest value with respect to the schedule time point in the time window 12 weeks post treatment until study end was used.|At the end of 24 weeks of follow-up at Week 120|The ITT population included all participants randomized who received at least one dose of study medication.||percentage of participants|||Number
815016|NCT01095835|Secondary|Percentage of Participants Achieving the Combined Response at the End of Treatment|Combined response was defined as ALT normalization plus lowering of HBV-DNA levels to <20,000 copies/mL (<3,400 IU/mL). In case of missing end of treatment measurements, the next available post-treatment value was used.|At end of treatment at Week 48 or 96 depending on the study arm|The ITT population included all participants randomized who received at least one dose of study medication.||percentage of participants|||Number
815017|NCT01095835|Primary|Percentage of Participants Achieving the Combined Response at the End of the Follow-up Period|Combined response was defined as alanine aminotransferase (ALT) normalization plus lowering of hepatitis B virus (HBV) deoxyribo nucleic acid (DNA) levels to <20,000 copies/mL (<3,400 IU/mL) and was measured at the end of the 48-week follow-up period. Participants with missing 48 weeks follow-up measurements were considered as non-responders. However, if the scheduled 48-weeks post-treatment tests were performed earlier or later than 48 weeks post-treatment, but not earlier than 36 weeks post-treatment, the corresponding results were considered to determine response.|At the end of the 48-week follow-up period at Week 144|The ITT population included all participants randomized who received at least one dose of study medication.||percentage of participants|||Number
815018|NCT01095887|Primary|Number of Subjects With Antibody-Mediated Rejection (AMR) Within 3 Months of Kidney Transplant||3 months after kidney transplant surgery|||participants|||Number
815019|NCT01095978|Secondary|Termination of Treatment|The number of participants who discontinued treatment is summarized.|Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)|The per-protocol population was analyzed.||Participants|||Number
815020|NCT01095978|Secondary|Compliance (Was the Dosage and Duration of Therapy Followed or Not; if Not - Explain the Reason)|Compliance was assessed by asking physicians if participants took their medication as directed. If participants did not take their medication as directed, physicians were asked to give the reason.|Visit 2 (10th-16th day or any other day after Inclusion Visit defined by physician)|The per-protocol population was analyzed.||Participants|||Number
815021|NCT01095978|Secondary|Adverse Effects|The number of participants experiencing adverse events, including serious adverse events, adverse events leading to study discontinuation, or adverse events leading to a dose reduction/temporarily stopping medication are summarized. See Reported Adverse Events for additional details.|Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)|The per-protocol population was analyzed.||Participants|||Number
815022|NCT01095978|Primary|Therapeutic Response|Therapeutic response (yes or no) was determined by the treating physician at Visit 2 based on the disappearance or significant alleviation of symptoms and regression of chest xray findings. The data are summarized by total number of participants and by age subgroups.|Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)|The per-protocol population was analyzed.||Participants|||Number
815023|NCT01095978|Primary|Previous Prescription of Other Antibiotic (Answer Whether Klacid SR is Given as the First or as Second Antibiotic)|Treating physicians were asked if Klacid SR was the first or second antibiotic prescribed to treat the participant. Results are presented for all participants and age subgroups.|Visit 1 (Initial visit)|The per-protocol population was analyzed.||Participants|||Number
815024|NCT01095978|Primary|Chest Xray - Necessary for Verification of the Diagnosis of Pneumonia , Community-acquired Pneumonia|Chest xrays were taken at Visit 1 to determine the presence of absence of community-acquired pneumonia. Findings are presented for all participants and by age subgroups.|Visit 1 (Initial visit)|The per-protocol population was analyzed.||Participants|||Number
815025|NCT01095978|Primary|Auscultation Findings|Participants were evaluated at Visit 1 (initial visit) and Visit 2 (10 to 16 days later or as defined by the treating physician). The presence of abnormal breathing sounds such as wheezing or crackles was determined by the treating physician using auscultation (listening for sounds within the body, usually with a stethoscope in the chest, neck, or abdomen) combined with their clinical judgment. Results are reported at Visit 1 and Visit 2 for all participants and by age subgroups. For participants with abnormal breathing sounds at Visit 1, resolution was noted at Visit 2.|Visit 1 (initial visit), Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)|The per-protocol population was analyzed.||Participants|||Number
816929|NCT01116882|Secondary|Any Repeat Revascularization||12 months|||participants|||Number
816930|NCT01116882|Secondary|Rate of Stent Thrombosis||12 months|||participants|||Number
815026|NCT01095978|Primary|Dyspnoea|Participants were evaluated at Visit 1 (initial visit) and Visit 2 (10 to 16 days later or as defined by the treating physician). The presence or absence of dyspnoea (difficulty breathing) was determined based on the clinical judgment of the treating physician and is reported for all participants and by age subgroup at Visit 1 and Visit 2. For participants with dyspnoea at Visit 1, whether the dyspnoea occurred at rest, after exercise, or both are reported. For those with dyspnoea at Visit 1, the number of participants whose original type of dyspnoea subsequently resolved at Visit 2 is noted.|Visit 1 (initial visit), Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)|The per-protocol population was analyzed.||Participants|||Number
815027|NCT01095978|Primary|Cough and Its Character|Participants were evaluated at Visit 1 (initial visit) and Visit 2 (10 to 16 days later or as defined by the treating physician). The presence of cough and the type of cough (productive, irritating, or both) was determined based on the clinical judgment of the treating physician. The presence or absence of cough are reported at Visits 1 and 2 for all participants and by age subgroups. For those participants who had a cough at Visit 1, the number of participants whose original type of cough subsequently resolved at Visit 2 is also presented.|Visit 1 (initial visit), Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)|The per-protocol population was analyzed.||Participants|||Number
815028|NCT01095978|Primary|Body Temperature|Body temperature was measured at Visit 1 (initial visit) and at Visit 2 (approximately 10 to 16 days later, or as defined by the treating physician). Fever was defined as body temperature greater than or equal to 37 degrees Celsius/98.6 Fahrenheit. The presence or absence of fever is reported at Visit 1 and 2 for all participants and by age subgroups.|Visit 1 (initial visit), Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)|The per-protocol population was analyzed. Visit 2 results are shown for those who had fever at Visit 1.||Participants|||Number
815029|NCT01096017|Secondary|Time to Change More Than or Equal to 15% (Time to Onset Response) Within 4 Hours After Drug Inhalation|Time to change more than or equal to 15% (time to onset response) within 4 hours after drug inhalation|At two visits during a maximum of 15 days|||Minutes||Standard Deviation|Mean
815030|NCT01096017|Secondary|Number of Patients With % Change in FEV1 (Forced Expiratory Volume in 1 Second) >15% Within 4 Hours After Drug Inhalation|Number of patients with % change in FEV1 >15% within 4 hours after drug inhalation.|At two visits during a maximum of 15 days|||Participants|||Number
815031|NCT01096017|Secondary|Time to Peak FEV1 (Forced Expiratory Volume in 1 Second) Within 4 Hours After Drug Inhalation|Time to peak measurement of FEV1 (min)|At two visits during a maximum of 15 days|||Minutes||Full Range|Median
815032|NCT01096017|Secondary|Maximum % Change in FEV1 (Forced Expiratory Volume in 1 Second) Within 4 Hours After Drug Inhalation|percent of pre-dose (ratio)|At two visits during a maximum of 15 days|||Percent change||Full Range|Geometric Mean
815033|NCT01096017|Secondary|FEV1 (Forced Expiratory Volume in 1 Second) at 240 Minutes After Inhalations of Study Drug as Percentage of Pre-dose|percent of pre-dose (ratio)|At two visits during a maximum of 15 days|||Percentage of Pre-Dose FEV1||Full Range|Geometric Mean
815034|NCT01096017|Secondary|FEV1 (Forced Expiratory Volume in 1 Second) at 180 Minutes After Inhalations of Study Drug as Percentage of Pre-dose|percent of pre-dose (ratio)|At two visits during a maximum of 15 days|||Percentage of Pre-Dose FEV1||Full Range|Geometric Mean
815035|NCT01096017|Secondary|FEV1 (Forced Expiratory Volume in 1 Second) at 120 Minutes After Inhalations of Study Drug as Percentage of Pre-dose|percent of pre-dose (ratio)|At two visits during a maximum of 15 days|||Percentage of Pre-Dose FEV1||Full Range|Geometric Mean
815036|NCT01096017|Secondary|FEV1 (Forced Expiratory Volume in 1 Second) at 60 Minutes After Inhalations of Study Drug as Percentage of Pre-dose|percent of pre-dose (ratio)|At two visits during a maximum of 15 days|||Percentage of Pre-Dose FEV1||Full Range|Geometric Mean
815037|NCT01096017|Secondary|FEV1 (Forced Expiratory Volume in 1 Second) at 30 Minutes After Inhalations of Study Drug as Percentage of Pre-dose|percent of pre-dose (ratio)|At two visits during a maximum of 15 days|||Percentage of Pre-Dose FEV1||Full Range|Geometric Mean
815038|NCT01096017|Secondary|FEV1 (Forced Expiratory Volume in 1 Second) at 15 Minutes After Inhalations of Study Drug as Percentage of Pre-dose|percent of pre-dose (ratio)|At two visits during a maximum of 15 days|||Percentage of Pre-Dose FEV1||Full Range|Geometric Mean
815039|NCT01096017|Secondary|FEV1 (Forced Expiratory Volume in 1 Second) at 5 Minutes After Inhalations of Study Drug as Percentage of Pre-dose|percent of pre-dose (ratio)|At two visits during a maximum of 15 days|||Percentage of Pre-Dose FEV1||Full Range|Geometric Mean
815040|NCT01096017|Primary|FEV1 (Forced Expiratory Volume in 1 Second) Area Under Curve (AUC) 0-4 Hours After Drug Inhalation|FEV1 (Forced Expiratory Volume in 1 second) AUC 0-4 hours after drug inhalation|At two visits during a maximum of 15 days. FEV1 timepoints: all time points t=5, 15, 30, 60, 120, 180 and 240 minutes.|||milliLiters x minutes||Full Range|Geometric Mean
815041|NCT01096056|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was event assessed by the investigator as causally related to the study vaccination.|Day 0 up to Month 7|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||Subjects|||Number
815042|NCT01096056|Secondary|Number of Subjects Reporting Any Potential Immune-Mediated-Diseases (pIMDs)|pIMDs are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.|Day 0 up to Month 7|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||Subjects|||Number
815043|NCT01096056|Secondary|Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs)|For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination, grade 3 was defined as symptom that prevented normal activity and related was symptom assessed by the investigator as causally related to the study vaccination.|Day 0 up to Month 7|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||Subjects|||Number
815044|NCT01096056|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was event that prevented normal activities and Related was defined as unsolicited AE assessed by the investigator to be causally related to the study vaccination.|Within 21 days after any vaccination with New generation influenza vaccine GSK2186877A|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||Subjects|||Number
815045|NCT01096056|Secondary|Duration of Solicited General AEs|Duration was defined as number of days with any grade of local symptoms following each dose of New generation influenza vaccine GSK2186877A. Dose 1 application of vaccine involved subjects in Influenza vaccine GSK2186877A formulation 1 Group and Influenza vaccine GSK2186877A formulation 2 Group while Dose 2 application of vaccine involved only subjects in the Influenza vaccine GSK2186877A formulation 1 Group.|Within 7 days following any vaccination with New generation influenza vaccine GSK2186877A|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.||Days||Full Range|Median
815046|NCT01096056|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs|Any temperature was defined as axillary temperature ≥37.5°C, grade 3 temperature was axillary temperature >39.0°C. For other symptoms, any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination. Grade 3 drowsiness was defined as general symptom that prevented normal activity, grade 3 irritability was crying that cannot be comforted/prevented normal activity, grade 3 loss of appetite was not eating at all and grade 3 vomiting was defined as ≥3 episode of vomiting/day. Related was symptom assessed by the investigator as causally related to vaccination.|Within 7 days following any vaccination with New generation influenza vaccine GSK2186877A|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||Subjects|||Number
815047|NCT01096056|Secondary|Duration of Solicited Local AEs|Duration was defined as number of days with any grade of local symptoms following each dose of New generation influenza vaccine GSK2186877A. Dose 1 application of vaccine involved Influenza vaccine GSK2186877A formulation 1 Group and Influenza vaccine GSK2186877A formulation 2 Group while Dose 2 involved only Influenza vaccine GSK2186877A formulation 1 Group.|Within 7 days following any vaccination with New generation influenza vaccine GSK2186877A|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.||Days||Full Range|Median
815048|NCT01096056|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)|Grade 3 redness and swelling was > 50 millimeter (mm) and grade 3 pain was subjects crying when limb was moved/spontaneously painful. Any was occurrence of any local symptom regardless of their intensity grade.|Within 7 days following any vaccination with New generation influenza vaccine GSK2186877A|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||Subjects|||Number
815049|NCT01096056|Secondary|HI Antibody Geometric Mean Fold Rise (GMFR)|GMFR was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The vaccine strains included Flu A/CAL/7/09 H1N1, Flu A/Uru/716/07 H3N2 and FluB/Bri/60/08 Victoria antigens.|Day 42|The immunogenicity analysis was based on the Total Vaccinated cohort which included all vaccinated subjects for whom immunogenicity data were available.||fold increase||95% Confidence Interval|Geometric Mean
815050|NCT01096056|Secondary|The Number of Subjects Seroconverted to HI Antibodies|A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains included Flu A/CAL/7/09 H1N1, Flu A/Uru/716/07 H3N2 and FluB/Bri/60/08 Victoria antigens.|Day 42|The immunogenicity analysis was based on the Total Vaccinated cohort which included all vaccinated subjects for whom immunogenicity data were available.||Subjects|||Number
815051|NCT01096056|Secondary|The Number of Subjects Seroprotected to HI Antibodies|A seroprotected subject was defined as a subject with a serum HI titre greater than or equal to 1:40 that usually is accepted as indicating protection. The vaccine strains included Flu A/CAL/7/09 H1N1, Flu A/Uru/716/07 H3N2 and FluB/Bri/60/08 Victoria antigens.|At Day 0 and Day 42|The immunogenicity analysis was based on the Total Vaccinated cohort which included all vaccinated subjects for whom immunogenicity data were available.||Subjects|||Number
815052|NCT01096056|Secondary|The Number of Subjects Seropositive to HI Antibodies|A seropositive subject was defined as a subject with antibody titer greater than or equal to 1:10. The vaccine strains included Flu A/CAL/7/09 H1N1, Flu A/Uru/716/07 H3N2 and FluB/Bri/60/08 Victoria antigens.|At Day 0 and Day 42|The immunogenicity analysis was based on the Total Vaccinated cohort which included all vaccinated subjects for whom immunogenicity data were available.||Subjects|||Number
815053|NCT01096056|Secondary|Haemagglutination Inhibition (HI) Antibody Titers|Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains included Flu A/CAL/7/09 H1N1, Flu A/Uru/716/07 H3N2 and FluB/Bri/60/08 Victoria antigens.|At Day 0 and Day 42|The immunogenicity analysis was based on the Total Vaccinated cohort which included all vaccinated subjects for whom immunogenicity data were available.||Titers||95% Confidence Interval|Geometric Mean
815054|NCT01096056|Primary|Number of Subjects Reporting Fever Grade 2 or Higher|Fever grade greater than or equal to 2 i.e. ≥2 was defined as axillary temperature >38 degree centigrade (°C).|Within 7 days following any vaccination with New generation influenza vaccine GSK2186877A|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
815055|NCT01096186|Secondary|Patient Global Impression (PGI)|"Satisfaction of IPX066 using Patient Global Impression (PGI) 7-point scale.
Patient Global Impression 0-7 – higher value indicates increased improvement from study start"|9 months|All enrolled subjects with available data||units on a scale||Standard Deviation|Mean
815073|NCT01096680|Secondary|PVT Scores by Timepoint|PVT assesses behavioral alertness. Subjects were required to respond to a visual stimulus by pressing a button on a mechanical device and the reaction time was measured. Higher scores indicate attention lapses.|Over a period of 12 hours|FAS||msec||Standard Error|Least Squares Mean
815056|NCT01096186|Secondary|Total UPDRS Parts I-IV|"Analysis of the Change from Baseline in the sum of the Unified Parkinson's Disease Rating Scale (UPDRS) Part I (Mentation, Behavior and Mood), Part II (Activities of Daily Living), UPDRS Part III (Motor Examination), and Part IV (Complications of Therapy [In the past week]) at End of Study. Includes both scoring by a clinician and a historical report of mental functioning, activities of daily living and complications of therapy in the past week obtained by questioning the patient.
Unified Parkinson’s Disease Rating Scale (UPDRS) – Four Parts Higher score values represent a worse outcome.
Subscales II and III were summed:
Part I: Mentation, Behavior and Mood – 4 questions 1-4 Score range: 1-16 Part II: Activities of Daily Living – 13 questions 5-17 Score range: 0-52 Part III: Motor Examination – 19 questions 18-31 and 25 total assessments Score range: 0-100 Part IV: Complications of Therapy (In the past week) – 11 questions Score range: 0-25"|9 months|All enrolled subjects with available data||units on a scale||Standard Deviation|Mean
815057|NCT01096186|Primary|Change From Baseline in the Sum of UPDRS Part II + UPDRS Part III|"Analysis of the Change from Baseline in the sum of the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) + UPDRS Part III (Motor Examination) at End of Study.
Unified Parkinson’s Disease Rating Scale (UPDRS) – Four Parts Higher score values represent a worse outcome.
Subscales II and III were summed:
Part I: Mentation, Behavior and Mood – 4 questions 1-4 Score range: 1-16 Part II: Activities of Daily Living – 13 questions 5-17 Score range: 0-52 Part III: Motor Examination – 19 questions 18-31 and 25 total assessments Score range: 0-100 Part IV: Complications of Therapy (In the past week) – 11 questions Score range: 0-25"|9 months|All enrolled subjects with available data||units on a scale||Standard Deviation|Mean
815058|NCT01096316|Secondary|Potential Facilitators and Barriers to Sustainability|Providers' and administrators' perceived barriers and facilitators to continue providing the intervention after study end.|18 months||||||
815059|NCT01096316|Secondary|Quality of Depression Care Indicators|Intervention impact on quality of depression care indicators and satisfaction with depression care. Number of participants receiving 4 or more mental health visits are reported. Receiving 4 or more mental health visits has previously been used in depression randomized control trials as a measure of the quality of depression treatment received by a patient|12 months|||participants|||Number
815060|NCT01096316|Primary|Functional Outcome|Impact of the intervention on functional outcomes of patients. Functional impairment was measured using the Sheehan Disability Scale. The Sheehan disability scale is the average of 3 items assessing impairment in social, work and family responsibilities. Each item is rated 0 (no impairment) to 10 (totally impaired) and the 3 ratings are averaged for the Sheehan disability scale reported below.|12 months|||units on a scale||Standard Deviation|Mean
815061|NCT01096316|Primary|Depression Treatment Outcome|Impact of the intervention on depression treatment outcomes, including change in depressive symptoms and treatment response. In particular, the depression scale from the Hopkins Symptom Checklist 20 (SCL-20) was used to assess depression severity at the assessments. The SCL-20 ranges from 0 (no depression) to 4 (severe depression),|12 months|||units on a scale||Standard Deviation|Mean
815062|NCT01096342|Secondary|Duration of Response|The distribution of duration of response will be estimated using the method of Kaplan-Meier.|Date at which the patient's objective status is first noted to be either an sCR, CR, PR, or VGPR to the earliest date progression is documented, assessed up to 3 years|Duration of Response was not analyzed due to lack of responses.|||||
815063|NCT01096342|Secondary|Progression-free Survival|The distribution of progression-free survival will be estimated using the method of Kaplan-Meier.|Time from registration to progression or death due to any cause, assessed up to 3 years|All 15 evaluable participants were analyzed for Progression-Free Survival.||months||95% Confidence Interval|Median
815064|NCT01096342|Primary|Number of Confirmed Responses, Defined to be an sCR, CR, VGPR, or PR Noted as the Objective Status on Two Consecutive Evaluations.|"Complete Response (CR):
Negative immunofixation of serum and urine Normalization of FLC ratio < 5% plasma cells in bone marrow Disappearance of any soft tissue plasmacytomas
Stringent Complete Response (sCR):
CR, as above, with absence of clonal cells in bone marrow
Partial Response (PR):
One of the following:
A ≥ 50% reduction of measurable serum M-protein.
A reduction in 24h measurable urinary M-protein by ≥ 90% or to <200 mg per 24h.
A ≥ 50% decrease in the difference between involved and uninvolved FLC levels.
≥50% reduction in bone marrow plasma cells is required in place of Mprotein, provided baseline percentage was ≥ 30%
A ≥50% reduction in the size of soft tissue plasmacytomas.
Very Good Partial Response (VGPR):
PR as defined above in addition to having serum and urine M-component detectable by immunofixation but not on electrophoresis."|Up to 3 years|Fifteen of the 16 accrued Phase II participants were analyzed (1 participant was a protocol violation).||participants|||Number
815065|NCT01096446|Secondary|Initiation of Glucose|Infants were monitored to see if insulin was started to control hyperglycemia.|First 7 days of life||||||
815066|NCT01096446|Secondary|Maintain Appropriate for Gestational Age Status at Discharge|Recorded all infant's weights at discharge and plotted the anthropometric values on the Fenton Growth Charts.|Entire hospital stay||||||
815067|NCT01096446|Secondary|Infants Will Achieve 90 Calories/Kilogram/Day|Monitored the calorie intake of infants to see which group was able to acheive 90 cal/kg/day from the total parenteral nutrition.|First 14 days of Life||||||
815068|NCT01096446|Secondary|Regain Birthweight|Infants in both groups weights were monitored to determine if giving higher infusions of intravenous fat emulsion helped the infants regain their birthweight sooner.|First 2 weeks of life||||||
815069|NCT01096446|Primary|Number of Infants Serum Triglyceride Level Higher Than 200 mg/dl|Each day the infants have a serum triglyceride level drawn to assess their tolerance of the intravenous fat emulsion being given.|First 7 days of life|This study was ended early due to 100% of the infants in the experimental group developed hypertriglyceridemia of 200 mg/dl or greater||participants|||Number
815070|NCT01096550|Primary|Percentage of Participants Meeting Diagnosis of Opioid Dependence on Composite International Diagnostic Interview-2 (CIDI-2)||6 months post-baseline|||percentage of opioid dependent subjects|||Number
815071|NCT01096589|Secondary|Assessment of Safety by Incidence of Adverse Events.||3 weeks||||||
815072|NCT01096589|Primary|Percent Volume Change of Affected Limb at End of Treatment Compared to Baseline.||baseline and after 3 weeks of treatment|Patients must have completed the first week.||% volume change measured in mL.||Standard Deviation|Mean
816931|NCT01116882|Secondary|Ischemia-driven Target Lesion Revascularization||12 months|||participants|||Number
815077|NCT01096680|Primary|Maintenance of Wakefulness Test (MWT)|"The MWT was conducted to determine the subjects' ability to stay awake. Subjects sat in a darkened room and were told to stay awake as long as possible during the 30 minute session. This is an indicator of how well you are able to function and remain alert in quiet times of inactivity. Higher times are better."|Over a period of 8 hours|Full Analysis Set (FAS) is defined as all randomized subjects with any primary efficacy assessment.||Minutes||Standard Error|Least Squares Mean
815078|NCT01096771|Secondary|Hypertriglyceridemia|Defined as triglyceride level >400|96 hours|||participants|||Number
815079|NCT01096771|Secondary|Allergic Reactions||96 hours|||participants|||Number
815080|NCT01096771|Secondary|Hospital Length of Stay||30 days|||days||Standard Deviation|Mean
815081|NCT01096771|Secondary|Biomarkers (C-reactive Protein)||96 hours|||mg/L||Standard Deviation|Mean
815082|NCT01096771|Secondary|Organ Failures||30 days|||participants|||Number
815083|NCT01096771|Secondary|New Infection|We will use standard clinical criteria including but not limited to: fever, pyuria, new inflitrate on chest x-ray, positive blood cultures, abscess detected on imaging, leukocytosis, and positive skin or soft-tissue cultures to identify presence of new bacterial infections occurring after enrollment.|30 days|||participants|||Number
815084|NCT01096771|Secondary|30 Day Mortality||30 days|||participants|||Number
815085|NCT01096771|Secondary|PaO2:FiO2 Ratio|PaO2:FiO2 ratio at time of 2nd Bronchoalveolar Lavage (BAL) or end of study drug administration.|4 days|||mmHg||Standard Deviation|Mean
815086|NCT01096771|Secondary|Ventilator Days||30 days|||days||Standard Deviation|Mean
815087|NCT01096771|Primary|Bronchoalveolar Lavage Fluid Interleukin-8 Concentrations||96 hours|Each arm has one less subject than specified in the participate flow module. One is secondary to the fact that the subject refused the 2nd bronchoscopy and the other is because the primary physician felt the subject was too sick to undergo the 2nd bronchscopy.||pg/mL||Standard Deviation|Mean
815088|NCT01096784|Secondary|Serum Concentrations of Acid Labile Sub-unit (ALS) After Intravenous (IV) Infusion of rhIGF-1/rhIGFBP-3||Day 7 and Week 40 Post Menstrual Age|FAS.||microgram per liter||Standard Deviation|Mean
815089|NCT01096784|Secondary|Serum Concentrations of IGFBP-3 After Intravenous (IV) Infusion of rhIGF-1/rhIGFBP-3||Day 0 and Week 40 Post Menstrual Age|FAS.||microgram per liter||Standard Deviation|Mean
815090|NCT01096784|Secondary|Percentage of Serum IGF-1 Concentrations Falling Within Target Range After Infusion of rhIGF-1/rhIGFBP-3|Serum samples were collected from treated and control participants for quantification of IGF-1 using validated immunoassays. Target range of serum IGF-1 was 28-109 mcg/L. The percentage of serum IGF-1 levels across treated participants that fall within the range was reported.|Day 0 to 40 Weeks Post Menstrual Age (EOS)|FAS was analysed.||percentage of serum concentration|||Number
815091|NCT01096784|Secondary|Number of Participants With Treatment Emergent Adverse Event (TEAE) and Treatment Emergent Serious Adverse Event (TESAE)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product.|Day 0 to 40 Weeks Post Menstrual Age (EOS)|Safety Analysis Set (SAF) included all randomized participants who received the study drug and participants in the control group who received standard of care, and for whom at least 1 safety assessment was completed.||participants|||Number
815092|NCT01096784|Secondary|Percentage of Participants With Maximum Severity of ROP Stage Greater Than or Equal to 3 at Any Time During the Study|ROP was measured by central exams with fundus photography. Maximum severity of ROP stage across all retinal examinations included International Classification of Retinopathy of Prematurity, a 5 stage system, for the classification of ROP with 7 different outcomes of the ROP stage in each retinal examination: 0, 1, 2, 3, 3+, 4, and 5. This is an ordinal scale with higher numbers indicating a more severe outcome.|Day 0 to 40 Weeks Post Menstrual Age (EOS)|FAS.||Percentage of participants|||Number
815093|NCT01096784|Secondary|Area Under Curve for Maximum Severity of ROP Stage (AUC for ROP)|Integration of the maximum severity of ROP stage and the duration of the time interval with respect to each retinal examination. AUC for the maximum severity of ROP was calculated using the trapezoidal rule. The area between each 2 visits was calculated by multiplying the average of the maximum severities of the 2 visits by the difference in days and analyzed using the van Elteren test. ROP is classified according to the International Classification and is subdivided into 5 stages (1-5) with higher values representing greater severity.|Every 1-2 weeks starting at 31 weeks PMA/ EOS +/- 4 days|Full analysis set with number of participants evaluable for this outcome.||ROP severity score*days||Standard Deviation|Mean
815094|NCT01096784|Secondary|Percentage of Participants With Intraventricular Hemorrhage (IVH)|Development of intraventricular hemorrhage was assessed by cerebral ultrasound and coded as a binary endpoint (presence or absence of IVH).|Day 0 to 40 Weeks Post Menstrual Age (EOS)|FAS||percentage of participants|||Number
815095|NCT01096784|Secondary|Brain Development Assessed by Brain Volume at 40 Weeks PMA/EOS|Brain volume was measured using cerebral magnetic resonance imaging (MRI). Brain volume included cerebrospinal volume, gray matter volume, white matter volume, and total cerebellar volume|40 Weeks PMA/ (EOS) +/- 4 days|FAS||cubic centimeter||Standard Deviation|Mean
815096|NCT01096784|Secondary|Rate of Change in Head Circumference|The rate of change is the head circumference change per day in centimetre (cm).|Day 0 to 40 Weeks Post Menstrual Age (EOS)|FAS||cm/day||95% Confidence Interval|Mean
815097|NCT01096784|Secondary|Rate of Change in Length|The rate of change is the length change per day in centimeter (cm).|Day 0 to 40 Weeks Post Menstrual Age (EOS)|FAS||centimeter per day (cm/day)||95% Confidence Interval|Mean
815098|NCT01096784|Secondary|Rate of Change in Body Weight|The rate of change is the rate of specific body weight change per day in kilogram (kg).|Day 0 to 40 Weeks Post Menstrual Age (EOS)|FAS||kilogram per day (kg/day)||95% Confidence Interval|Mean
815192|NCT01089569|Primary|HbA1c Change|"Measure the changes in HbA1C attributable to exenatide, insulin glargine and their combination.
Employ CGM with AGP analysis to determine if there is an incremental benefit for subjects who do not reach target to add exenatide to insulin glargine or insulin glargine to exenatide in patients taking metformin."|baseline to final visit (32 weeks)|||%HbA1c||Standard Deviation|Mean
815099|NCT01096784|Secondary|Number of Participants With Bronchopulmonary Dysplasia (BPD)|"Severity of BPD as mild, moderate and severe were based on the National Institute of Child Health and Human Development (NICHD) guidelines for preterm infants born at gestational age (GA) less than (<) 32 weeks.
Mild: oxygen requirement during the first 28 days but in room air at PMA 36 weeks or discharge to home, whichever comes first.
Moderate BPD: oxygen requirement during the first 28 days and oxygen <30 percent (%) at PMA 36 weeks or discharge to home, whichever comes first.
Severe BPD: oxygen requirement during the first 28 days and oxygen greater than equal (≥)30% through head hood or nasal canula, or continuous positive airway pressure, or mechanical ventilation, or high flow nasal cannula ≥2 L/min at PMA 36 weeks or discharge to home, whichever comes first."|At 36 Weeks Post Menstrual Age|FAS with participants evaluable for this outcome.||participants|||Number
815100|NCT01096784|Secondary|Time to Discharge From Neonatal Intensive Care (TDNIC)||Day 0 to 40 Weeks Post Menstrual Age (EOS)|FAS with number of participants evaluable for this outcome.||Days||Full Range|Median
815101|NCT01096784|Primary|Severity of Retinopathy of Prematurity (ROP) as Compared to the Severity of ROP in an Untreated Control Population|ROP was measured by central exams with fundus photography. Maximum severity of ROP stage across all retinal examinations included International Classification of Retinopathy of Prematurity, a 5 stage system, for the classification of ROP with 7 different outcomes of the ROP stage in each retinal examination: 0, 1, 2, 3, 3+, 4, and 5. This is an ordinal scale with higher numbers indicating a more severe outcome. The maximum severity of ROP across all time points was assessed from 31 PMA weeks up to 40 PMA Weeks +/- 4 days (end of study).|End of study|Full Analysis Set (FAS) included all randomized participants who received the study drug and participants in the control group who received Standard of Care.||participants|||Number
815102|NCT01096810|Secondary|Antitumor Effect|To study the possible mechanisms involved in the clinical antitumor effect with determination of inhibition of angiogenesis|Antitumor effect|immunophenotyping was not performed in this study|||||
815103|NCT01096810|Primary|Response Rate|"The response rate - percentage of participants with overall response.
Overall response for any participants that has achieved at least a PR or better (PR, VGPR, CR, sCR) is defined using the International Uniform Response Criteria for Multiple Myeloma (Leukemia (2006)20:1467-1473) . Which requires the following: at least >50% reduction in SPEP, at least >90% reduction or <200 mg in UPEP, at least >50% reduction in the size of soft tissue plasmacytomas, no lytic bone lesions or similar definition that is accurate and appropriate."|from date of start of treatment until the date of best documented response up to date of progression|||percentage of participants|||Number
815104|NCT01096810|Primary|Time to Progression|"To determine the time to progression of asymptomatic multiple myeloma patients receiving TBL 12. The time to progression will be measured in units of a cycle (28 day cycles).
Progression is defined using the International Uniform Response Criteria for Multiple Myeloma (Leukemia (2006)20:1467-1473). Which requires one or more of the following: >25% increase in SPEP (must also be an absolute increase of at least 5 g/dL), >25% increase in UPEP (must also be an absolute increase of at least 200 mg/24 hours), >25% increase in bone marrow plasma cells (must also be an absolute increase of at least 10%), new lytic bone lesions or soft tissue plasmacytomas, or development of hypercalcemia (not attributable to any other cause)."|From date of treatment until the date of first documented progression|||cycles||Full Range|Median
815105|NCT01096823|Primary|Disease Activity Scale (DAS)28|"is a combined index that measures disease activity in patients with RA and remains a more thorough, established alternative to standard medical exams. This index includes a 28 tender joint count, 28 swollen joint count, Erythrocyte Sedimentation Rate (ESR), and general health assessment using a visual analogue scale. The ESR indirectly measures inflammation in the body and involves collecting blood samples, which will be performed by a qualified phlebotomist.
The DAS score is a complicated formula based on many factors so there are no set ranges, but the published standards are as follows:
A DAS28 score of higher than 5.1 is indicative of high disease activity, whereas a DAS28 below 3.2 indicates low disease activity. A patient is considered to be in remission if they have a DAS28 lower than 2.6. Source: DAS-Score.nl. Available at http://www.das-score.nl/www.das-score.nl/index.html. Accessed February 5, 2009."|post intervention (within 2 weeks of completing intervention)|||units on a scale||Standard Deviation|Mean
815106|NCT01096823|Primary|Health Assessment Questionnaire (HAQ)|"Items include questions about dressing and grooming, rising, eating, walking, hygiene, reaching, grip and making activities. The HAQ is one of the most widely recognized measures of patient functioning, with acceptable reliability and validity. It has been used successfully with adolescents as young as 13 years of age
Range: 0-100, lower scores indicate better health"|post intervention (within 2 weeks of completing intervention)|||units on a scale||Standard Deviation|Mean
815107|NCT01096823|Primary|Pain Disability Index (PDI)|"The PDI assess the impact of pain on ability to participate in basic life activities, including social activity, sexual behavior, self-care and life-support activity. The PDI has been used with patients as young as 15. Good internal reliability (α = .82) and validity have been reported. It takes less than 5 minutes to complete.
7 items, total measure range: 0-70, higher scores = higher interference/disability"|post intervention (within 2 weeks of completing intervention)|||units on a scale||Standard Deviation|Mean
815108|NCT01096823|Primary|Health Related Quality of Life - Short Form-36 (SF-36)|"The Health Related Quality of Life - Short Form-36 (SF-36) is a generic core HRQOL measure yielding an 8-scale profile of functional health and well being. The SF-36 performs comparatively better than other HRQOL measures in terms of reliability, validity, lightness of respondent/administrative burden. It can be completed in 5-10 minutes and has been used with children as young as 10 years of age.
Subscales - all ranges 0-100 with higher scores indicating increased quality of life Bodily Pain, 2 items General Health, 5 items Vitality, 4 items Mental Health, 5 items"|post intervention (within 2 weeks of completing intervention)|||units on a scale||Standard Deviation|Mean
815109|NCT01096875|Secondary|High Sensitive C-reactive Protein (hsCRP mg/L)||5 days postoperatively|||mg/L||Standard Error|Mean
815110|NCT01096875|Secondary|High Sensitive C-reactive Protein (hsCRP mg/L)||Postoperative 6th hours|||mg/L||Standard Error|Mean
815111|NCT01096875|Secondary|Left Ventricular Ejection Fraction (LVEF %) Measured at 30 Days Postoperatively||Change between statin and placebo groups at 30 days postoperatively|||percentage of LVEF||Standard Deviation|Mean
815112|NCT01096875|Primary|Endothelial Progenitor Cells (EPCs) Count (Cells/µl)||Postoperative 6th hours|||cells/µl||Standard Error|Mean
816932|NCT01116882|Secondary|Ischemia-driven Target Lesion Revascularization||30 days|||participants|||Number
815114|NCT01097005|Secondary|"Efficacy Evaluation Using the 4-rank Scale of Effective, Ineffective, Deterioration, or Impossible by the Investigator"|"Number of participants who evaluated for efficacy of clarithromycin with the 4-rank Scales (Effective, Ineffective, Deterioration, Impossible)"|When treatment with clarithromycin is discontinued, from 40 days to 1232 days|Analysis of Clinical Global Improvement (CGI). Number of patients with each rank scale.||Number of patients|||Number
815115|NCT01097005|Primary|Bacilli Negative Conversion Rate|Number of participants who tested positive for Bacilli before treatment and converted to Bacilli Negative at any point during the treatment with clarithromycin|During the treatment with clarithromycin, from 40 days to 1232 days|Analysis of the bacilli negative conversion||participants|||Number
815116|NCT01097057|Primary|Total Number of Participants Who Did Not Collect ≥5 x 10^6 CD34 Cells/kg in a Maximum of Four Apheresis Days|Number of participants who did not collect ≥5 x 10^6 CD34 cells/kg in up to four apheresis days|Up to Four Apheresis Days|Note: No patients were in this category.||Participants|||Count of Participants
815117|NCT01097057|Primary|Number of Participants Requiring One or Two Apheresis Collection Days to Reach ≥5 x 10^6 CD34 Cells/kg|Number of participants requiring one or two apheresis collection days to reach collection goal.|Up to Four Apheresis Days|||Participants|||Count of Participants
815118|NCT01097057|Primary|Number of Patients Who Achieved ≥5 x 10^6 CD34 Cells/kg in ≤4 Apheresis Days|Number of patients to collect at least 5 x 10^6 CD34 cells/kg in under 4 apheresis procedures.|Up to Four Apheresis Days|||Participants|||Count of Participants
815119|NCT01097057|Primary|Number of Patients to Mobilize ≥5 x 10^6 CD34 Cells/kg Autologous PBSC (Efficacy)|Number of patients who achieved ≥5 x 10^6 CD34 cells/kg autologous PBSC collection by apheresis.|One Month|||Participants|||Count of Participants
815120|NCT01097304|Secondary|Changes in Cell Proliferation in BE Epithelium From Baseline to Post-intervention as Assessed by Proliferation-related Ki-67 Antigen (Ki67) Immunostaining, Percentage of Positively Stained Nuclei, in BE Tissue Sections|Results will be analyzed using paired t-tests. Results (mean values and changes during intervention) will be reported along with the corresponding confidence intervals.|Baseline and 6 months||||||
815121|NCT01097304|Secondary|Changes in Gastric Bile Acid Composition, Measured by Liquid Chromatography-tandem Mass Spectrometry, From Baseline to Post-intervention|Results will be analyzed using paired t-tests. Results (mean values and changes during intervention) will be reported along with the corresponding confidence intervals.|Baseline and 6 months||||||
815122|NCT01097304|Primary|Reversal of Oxidative DNA Damage as Assessed by Changes in 8-hydroxy-2' -Deoxyguanosine (8OHdG) Immunostaining|8OHdG will be assessed by percentage of positively stained nuclear area. A paired t-test at a one-sided 0.05 significance level will be used to assess change during intervention. The observed results will be reported along with the corresponding confidence intervals.|Baseline to 6 months|participants with fewer than 500 total nuclei in longitudinally sectioned crypts opening to the lumen were excluded from analysis||% of strongly/moderately stained nuclei||Standard Deviation|Mean
815123|NCT01097343|Primary|Clopidogrel Resistance, Defined by P2Y12 Reaction Units (PRU)Value >230|P2Y12 Reaction Units are measured using the VerifyNow P2Y12 assay. Percent of patients with clopidogrel resistance defined by PRU value will be compared among low and high dose clopidogrel groups after 30 days of therapy.|Approximately 90 days|All patients completed the clinical protocol.||Number of Patients with PRU>230|||Number
815124|NCT01097421|Secondary|Patients Global Impressions (PGI)|Assessed by asking the patient at the final visit which alternative described how they had felt during the last 7 days as compared to how they felt at the baseline observation.|8-12 weeks|FAS||Participants|||Number
815125|NCT01097421|Secondary|Clinical Global Impressions (CGI)|Clinical Global Impression (CGI) scale at final visit|8-12 weeks|FAS||Participants|||Number
815126|NCT01097421|Secondary|Pramipexole (PPX) Dose|mean Pramipexole (PPX) dose|pre-treatment and after 8-12 weeks|FAS||mg/24 hr||Standard Deviation|Mean
815127|NCT01097421|Secondary|Adverse Events (AE) Considered Related to Observed Medication|Some patients had not related AEs as well as related AEs.|8-12 weeks|Safety Analysis Set (SAS) defined as all treated patients with a documented baseline observation.||Patients|||Number
815128|NCT01097421|Secondary|Patient Preference|Patients were asked about their preference regarding frequency of intake (once daily or three times daily)|8-12 weeks|FAS||Participants|||Number
815129|NCT01097421|Primary|Level of Adherence|Points on Morisky scale|8-12 weeks|FAS||Participants|||Number
815130|NCT01097421|Primary|Patients With a Score of 4 in Morisky Scale After 8-12 Weeks of Treatment|Morisky scale: 4 Yes/No Questions: Do you ever forget to take your medicine? Are you careless at times about taking your medicine? When you feel better do you sometimes stop taking your medicine? Sometimes if you feel worse when you take the medicine, do you stop taking it? Score one point for every NO: 0-1 points = low adherence, 2-3 points = moderate, 4 points = high adherence Confidence interval computed using the Clopper-Pearson (exact) method.|8-12 weeks|Full Analysis Set (FAS) defined as all patients who had taken at least one dose of the investigational medicinal product (IMP) and had a post-baseline assessment.||Percent||95% Confidence Interval|Number
815131|NCT01097460|Secondary|To Determine the Recommended Phase 2 Doses of MM-111 + Herceptin in Combination||2 years||||||
815132|NCT01097460|Primary|Incidence of Treatment-emergent AE’s||2 years|Patients that received at least one dose||participants|||Number
815133|NCT01089231|Secondary|Blood Lipids|Fasting venous blood samples were collected and blood lipid levels were determined by an external contract laboratory (LADR, Hannover; Germany) at baseline (t0), after one week (t1) and after 12 weeks (t12) of supplementation.|baseline and after 12 weeks|||mg/dl||Standard Deviation|Mean
815134|NCT01089231|Secondary|Fatty Acid Composition of Erythrocyte Membranes (Omega-3 Index)|Fasting venous blood samples were collected and RBC membrane FA composition including the omega-3 index, given as EPA + DHA, was analyzed at baseline and after 12 weeks according to the omega-3 index methodology (Harris & von Schacky, 2004). Results are presented as a percentage of the total identified FAs after response factor correction. The coefficient of variation for EPA + DHA was 5%. Quality was assured according to DIN ISO 15189.|baseline and after 12 weeks|||percentage of total fatty acids||Standard Deviation|Mean
815193|NCT01089582|Secondary|Number of Participants for the Physician's Assessment of Tolerance to ARICEPT at Week 12|The physician rated tolerance to ARICEPT as very good, good, adequate, unsatisfactory, or unevaluable.|Baseline to Week 12.|FAS.||participants|||Number
815194|NCT01089582|Secondary|Change in ARICEPT Dosing: Number of Participants at Each Final Dose of ARICEPT||Week 12.|FAS.||participants|||Number
815135|NCT01089231|Primary|Gene Expression Changes|Gene expression changes were measured by using whole genome microarrays. The expression values of all genes were compared between baseline and 4 hours, 7 days and twelve weeks after supplementation with FO or CO and differentially expressed genes were detected by standard two-state pooled-variance t-test (p<0,05). The number of differentially expressed genes (regulated genes)compared to the baseline values were determined for every study group in total as well as for every time point (4 hours, 7 days, 12 weeks)in total and specifically.|Gene expression changes (number of regulated genes)|||number of regulated genes|||Number
815136|NCT01089361|Other Pre-specified|PCR Substudy|PCR analysis on serum samples for presence of bacterial and mitochondrial DNA; This substudy was not done.|Daily up to 7 days|Not done|||||
815137|NCT01089361|Secondary|28 Day Mortality||28 days|||deaths|||Number
815138|NCT01089361|Secondary|Length of Intensive Care Unit (ICU) Stay||28 days|||days||Standard Deviation|Mean
815139|NCT01089361|Secondary|Acute Physiology and Chronic Health Evaluation (APACHE) Scores|Difference in average APACHE-II score between the intervention and placebo groups. APACHE II (Acute Physiology and Chronic Health Evaluation II) is a severity of disease classification system for patients admitted to the Intensive Care Unit. It uses an integer score from 0 to 71 that is computed based on age, 12 routine physiological measurements (i.e. heart rate, temperature, laboratory values), and previous health status obtained during the first 24 hours after ICU admission. Higher scores correspond to more severe disease and a higher risk of death.|First 24 hours after ICU admission|||APACHE score||Standard Deviation|Mean
815140|NCT01089361|Secondary|Organ Failures|Incidence of new organ failure as detected by Sequential Organ Failure Assessment [SOFA] score. Definitions are as follows. Central nervous system: delirium, coma, uncontrollable seizures, ICP>20cm H2O Cardiac: MAP <60mmHg, blood pressure supported with pressors, 50 > HR > 120 Respiratory: vented, RR>30, PaO2<60, PaCO2 > 55, Sat<92% Kidney: RIFLE criteria Anemia: Hct<27, transfusion of PRBC Thrombocytopenia: platelet < 50k, platelet transfusion Liver: biopsy, ALT>200, AST>200, t.bil>2.0, ALP>300 Coagulation failure: INR>2 if no anticoagulation therapy|7 days|||participants with increase in SOFA score|||Number
815141|NCT01089361|Secondary|Adverse Effects Attributable to Ketamine||7 days|||adverse events|||Number
815142|NCT01089361|Primary|Serum Levels of IL-6, IL-10 and TNFα||first 7 days of admission, Baseline and Day 7 reported|||pg/mL||Inter-Quartile Range|Median
815143|NCT01089413|Secondary|Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status|ECOG performance status measured on a 6 point scale to assess participant's performance status. 0=Fully active, able to carry on all pre-disease activities without restriction; 1=Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; 2=Ambulatory (>50% of waking hours), capable of all self-care, unable to carry out any work activities; 3=Capable of only limited self-care, confined to bed/chair >50% of waking hours; 4=Completely disabled, cannot carry on any self-care, totally confined to bed/chair; 5=Dead. 0=Best status, 5=Worst status. For each time-point, only categories with available data are reported.|Baseline up to Cycle 51 (1 cycle = 21 days)|FAS. Here, number of participants analyzed = participants with available data for this outcome and n = participants with available data for specified category, for each arm, respectively. No participants were evaluable for Cycles 48-50; hence, no data reported for these cycles.||percentage of participants|||Number
815144|NCT01089413|Secondary|Percentage of Participants With Best Overall Response|Tumor response was assessed using RECIST. Complete Response (CR): disappearance of all target and non-target lesions; Partial Response (PR): at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or appearance of one or more new non-target lesions and/or unequivocal progression of existing non-target lesions; Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started or persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. Results are reported as per age groups (<70 years, 70-80 years, and >80 years) as well as for overall participants.|Baseline up to disease progression or death (up to approximately 3 years)|FAS. Here, number of participants analyzed = participants with available data for this outcome.||percentage of participants|||Number
815145|NCT01089413|Secondary|Progression-Free Survival (PFS)|PFS (in months) was defined as: (date of progression or censored date - first date of treatment + 1)/30.44. Date of progression was derived from Response Evaluation Criteria in Solid Tumors (RECIST) evaluation or from last available date for participant who withdrew the study for progressive disease without progression according to RECIST evaluation. Progression was defined (as per RECIST) as at least a 20 percent (%) increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or appearance of one or more new non-target lesions and/or unequivocal progression of existing non-target lesions. PFS was estimated using Kaplan-Meier method. Results are reported as per age groups (<70 years and ≥70 years) as well as for overall participants.|Baseline up to disease progression or death (up to approximately 3 years)|FAS.||months||95% Confidence Interval|Median
815146|NCT01089413|Primary|Duration of Bevacizumab Treatment|Duration of bevacizumab treatment (in months) was defined as: (last treatment date - first treatment date plus [+] 1)/30.44. Duration of treatment was estimated using Kaplan-Meier method. Results are reported as per age groups (<70 years and greater than or equal to [≥] 70 years) as well as for overall participants.|Baseline up to end of treatment (up to approximately 3 years)|FAS.||months||95% Confidence Interval|Median
815147|NCT01089504|Secondary|Number of Participants With One or More Seizures|Any clinical or electrographic seizures occurring between study entry and all follow-up examinations and contacts.|18-22 months|Due to low enrollment, there was limited data available for analysis and therefore insufficient power to provide meaningful results for our primary or secondary analysis.||participants|||Number
815148|NCT01089504|Secondary|Mean Bayley Scales of Infant Development (BSID) Score - Motor|This part of the BSID assesses the degree of body control, large muscle coordination, finer manipulatory skills of the hands and fingers, dynamic movement, postural imitation, and the ability to recognize objects by sense of touch.|18-22 months|Due to low enrollment, there was limited data available for analysis and therefore insufficient power to provide meaningful results for our primary or secondary analysis.||units on a scale||Standard Deviation|Mean
815149|NCT01089504|Primary|Mean Bayley Scales of Infant Development (BSID) Score - Cognitive|The Bayley Scales of Infant Development (BSID) measure the mental and motor development and test the behavior of infants from one to 42 months of age. The test is intended to measure a child's level of development in three domains: cognitive, motor, and behavioral. The primary outcome is the Bayley assessment of development at 2 years of age. This is a standardized developmental exam that is normalized to the age of the child in months. The mean adjusted score is 100 with a standard deviation of 15 (higher being better) – very similar to the more familiar IQ score.|18-22 months|Due to low enrollment, there was limited data available for analysis and therefore insufficient power to provide meaningful results for our primary or secondary analysis.||units on a scale||Standard Deviation|Mean
815150|NCT01089517|Secondary|Proportion of Patients With at Least 1 Adverse Event||24 weeks|Safety Analysis Population||% of patients with adverse events|||Number
815151|NCT01089517|Secondary|The Proportion of Subjects Gaining 15 or More ETDRS Letters From Baseline at the Week 24 Visit|The proportion of subjects gaining 15 or more ETDRS letters from baseline at the Week 24 visit|24 weeks|Intent to Treat Population (last observation carried forward)||% subjects (i.e gaining >/=15 letters)|||Number
815152|NCT01089517|Primary|Mean Change in Visual Acuity From Baseline at the Week 24 Visit|The primary efficacy endpoint is the mean change in visual acuity from baseline at the Week 24 visit|24 Weeks|Intent to Treat Population (last observation carried forward)||ETDRS Letters||Standard Error|Mean
815153|NCT01089543|Secondary|Rate of Satisfactory Symptom Relief|"The rate of satisfactory symptom relief according to the DSQ defined as scores of <= 2 for all four major dyspepsia symptoms at week 8 and the diary recordings defined as a frequency of <= 1 day for all four major dyspepsia symptoms during the 7 days before week 8. Lastly, treatment success according to the participants' impression questionnaire where participants answered yes or no when asked if given the choice, whether they would want to continue to take the study drug after clinical trial completion. Values presented as percentage of participants."|Up to 8 Weeks (including 7 days prior)|Per Protocol Set (PPS) Population: defined as those participants who complied with the study protocol.||Percentage of participants|||Number
815154|NCT01089543|Primary|Rate of Complete Dyspepsia Symptom Relief|The rate of complete dyspepsia symptom relief according to the Dyspepsia Symptom Questionnaire (DSQ) was defined as a score of 1 for all four major dyspeptic symptoms at week 8 and according to the diary defined as all four dyspepsia symptoms recorded absent during the 7 days prior to week 8. Values presented as percentage of participants.|Up to 8 Weeks (including 7 days prior)|Per Protocol Set (PPS) population defined as those participants who complied with the study protocol.||Percentage of Participants|||Number
815155|NCT01089556|Secondary|Number of Participants Who Discontinued From Study Between Week 8 and Week 16 Endpoint||Week 8 through Week 16|All randomized participants who received at least one dose of study drug during Weeks 9-16 (Study Period III).||participants|||Number
815156|NCT01089556|Other Pre-specified|Number of Participants Who Discontinued From Study Between Baseline and Week 8 Endpoint||Baseline through Week 8|All randomized participants who received at least one dose of study drug during Weeks 1-8 (Study Period II).||participants|||Number
815157|NCT01089556|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) Between Week 8 and Week 16 Endpoint|TEAEs in Study Period III are events that began or worsened after Week 8 compared with the period before Week 8.|Week 8 through Week 16|All randomized participants who received at least one dose of study drug during Weeks 9-16 (Study Period III).||participants|||Number
815158|NCT01089556|Other Pre-specified|Number of Participants With Treatment Emergent Adverse Events (TEAE) Between Baseline and Week 8 Endpoint|TEAEs in Study Period II are events that began or worsened after Week 0 compared with the period before Week 0.|Baseline through Week 8|All randomized participants who received at least one dose of study drug during Weeks 1-8 (Study Period II).||participants|||Number
815159|NCT01089556|Secondary|Mean Change in Heart Rate From Week 8 to Week 16 Endpoint|Least Squares (LS) mean values are controlled for treatment, site, baseline value, treatment*site and treatment in Study Period II.|Week 8, Week 16|All randomized participants who received at least one dose of study drug, and had Week 8 and at least one heart rate measurement during Weeks 9- 16 (Study Period III). Last observation carried forward (LOCF) principle was used.||beats per minute (bpm)||95% Confidence Interval|Least Squares Mean
815160|NCT01089556|Other Pre-specified|Mean Change in Heart Rate From Baseline to Week 8 Endpoint|Least Squares (LS) mean values are controlled for treatment, site, baseline value, and treatment*site.|Baseline, Week 8|All randomized participants who received at least one dose of study drug, and had baseline and at least one post-baseline heart rate measurement during Weeks 1-8 (Study Period II). Last observation carried forward (LOCF) principle was used.||beats per minute (bpm)||95% Confidence Interval|Least Squares Mean
815161|NCT01089556|Secondary|Mean Change in Blood Pressure (BP) From Week 8 to Week 16 Endpoint|Least Squares (LS) mean values are controlled for treatment, site, baseline value, treatment*site and treatment in Study Period II.|Week 8, Week 16|All randomized participants who received at least one dose of study drug, and had Week 8 and at least one BP measurement during Weeks 9-16 (Study Period III). Last observation carried forward (LOCF) principle was used.||millimeter of mercury (mm Hg)||95% Confidence Interval|Least Squares Mean
815162|NCT01089556|Other Pre-specified|Mean Change in Blood Pressure (BP) From Baseline to Week 8 Endpoint|Least Squares (LS) mean values are controlled for treatment, site, baseline value, and treatment*site.|Baseline, Week 8|All randomized participants who received at least one dose of study drug, and had baseline and at least one post-baseline BP measurement during Week 1-8 (Study Period II). Last observation carried forward (LOCF) principle was used.||millimeter of mercury (mm Hg)||95% Confidence Interval|Least Squares Mean
815163|NCT01089556|Secondary|Patient Global Impression of Improvement (PGI-I) Score at Week 16 Endpoint|Measures participant's perception of improvement at the time of assessment compared with the start of treatment for Study Period III. The score ranges from 1 (very much better) to 7 (very much worse). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit, baseline*visit and treatment in Study Period II.|Week 16|All randomized participants who received at least one dose of study drug, and at least one PGI-I measurement during Weeks 9-16 (Study Period III).||units on a scale||95% Confidence Interval|Least Squares Mean
816933|NCT01116882|Secondary|All Cause Mortality at 30 Days||30 days|The denominator for MACE at 30 days is defined as patients who either died to 30d or had follow up of at least 23 days.||participants|||Number
815164|NCT01089556|Other Pre-specified|Patient Global Impression of Improvement (PGI-I) Score at Week 8 Endpoint|Measures participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, visit, and treatment*visit.|Week 8|All randomized participants who received at least one dose of study drug, and at least one post-baseline PGI-I measurement during Weeks 1-8 (Study Period II).||units on a scale||95% Confidence Interval|Least Squares Mean
815165|NCT01089556|Other Pre-specified|Average Number of Hours Worked for Pay Per Week Week 8 Through Week 16|Data presented are the average number of hours worked for pay per week during the last 8 weeks.|Week 8 through Week 16|All randomized participants who received at least one dose of study drug and had worked for pay during Weeks 9-16 (Study Period III).||hours||Standard Deviation|Mean
815166|NCT01089556|Other Pre-specified|Average Number of Hours Worked for Pay Per Week Baseline Through Week 8|Data presented are the average number of hours worked for pay per week during the last 8 weeks.|Baseline through Week 8|All randomized participants who received at least one dose of study drug and had worked for pay during Weeks 1-8 (Study Period II).||hours||Standard Deviation|Mean
815167|NCT01089556|Secondary|Resource Utilization (Number of Days Hospitalized, Number of Days of Sick Leave) Week 8 Through Week 16|Data presented are the number of days hospitalized and work/school missed (sick leave) due to diabetic peripheral neuropathic pain (DPNP) during the last 8 weeks.|Week 8 through Week 16|All randomized participants who received at least one dose of study drug and provided information of hospitalization and sick leave during Weeks 9-16 (Study Period III).||days||Standard Deviation|Mean
815168|NCT01089556|Other Pre-specified|Resource Utilization (Number of Days Hospitalized, Number of Days of Sick Leave) Baseline Through Week 8|Data presented are the number of days hospitalized and work/school missed (sick leave) due to diabetic peripheral neuropathic pain (DPNP) during the last 8 weeks.|Baseline through Week 8|All randomized participants who received at least one dose of study drug and provided information of hospitalization and sick leave during Weeks 1-8 (Study Period II).||days||Standard Deviation|Mean
815169|NCT01089556|Secondary|Mean Change From Week 8 to Week 16 Endpoint in Hospital Anxiety and Depression Scale (HADS)|A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale (0-3), giving maximum scores of 21 for anxiety and for depression. Scores of 11 or more on either subscale are considered to be a significant case of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7 represent 'normal.' Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit, baseline*visit and treatment in Study Period II.|Week 8, Week 16|All randomized participants who received at least one dose of study drug, and had Week 8 and at least one HADS measurements during Weeks 9-16 (Study Period III).||units on a scale||95% Confidence Interval|Least Squares Mean
815170|NCT01089556|Other Pre-specified|Mean Change From Baseline to Week 8 Endpoint in Hospital Anxiety and Depression Scale (HADS)|A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale (0-3), giving maximum scores of 21 for anxiety and for depression. Scores of 11 or more on either subscale are considered to be a significant case of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7 represent 'normal.' Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit and baseline*visit.|Baseline, Week 8|All randomized participants who received at least one dose of study drug, and had baseline and at least one post-baseline HADS measurements during Weeks 1-8 (Study Period II).||units on a scale||95% Confidence Interval|Least Squares Mean
815171|NCT01089556|Secondary|Mean Change From Week 8 to Week 16 Endpoint in Sheehan Disability Scale (SDS)|The SDS is completed by the participant and is used to assess the effect of the participant's symptoms on their work (Item 1), social (Item 2), and family life (Item 3). Each item is measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. Total scores is the sum of the 3 items and range from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. Least Squares (LS) Mean values are controlled for treatment, site, baseline value, treatment*site and treatment in Study Period II.|Week 8, Week 16|All randomized participants who received at least one dose of study drug, and had Week 8 and at least one SDS measurement during Weeks 9-16 (Study Period III). Last observation carried forward (LOCF) principle was used.||units on a scale||95% Confidence Interval|Least Squares Mean
815172|NCT01089556|Other Pre-specified|Mean Change From Baseline to Week 8 Endpoint in Sheehan Disability Scale (SDS)|The SDS is completed by the participant and is used to assess the effect of the participant's symptoms on their work (Item 1), social (Item 2), and family life (Item 3). Each item is measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. Total scores is the sum of the 3 items and range from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. Least Squares (LS) mean values are controlled for treatment, site, baseline value and treatment*site.|Baseline, Week 8|All randomized participants who received at least one dose of study drug, and had baseline and at least one post-baseline SDS measurement during Weeks 1-8 (Study Period II). Last observation carried forward (LOCF) principle was used.||units on a scale||95% Confidence Interval|Least Squares Mean
815173|NCT01089556|Secondary|Mean Change From Week 8 to Week 16 Endpoint on the Neuropathic Pain Symptom Inventory (NPSI) Questionnaire|The NPSI is a 12-item self-administered questionnaire to assess 5 different dimensions of neuropathic pain: superficial spontaneous burning pain, deep spontaneous pressing pain, paroxysmal pain, evoked pains, and paresthesias/dysesthesias. A total score ranges from 0 to 100. Higher score indicates a greater intensity of pain. Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit, baseline*visit and treatment in Study Period II.|Week 8, Week 16|All randomized participants who received at least one dose of study drug, and had Week 8 and at least one NPSI measurements during Weeks 9-16 (Study Period III).||units on a scale||95% Confidence Interval|Least Squares Mean
816934|NCT01116882|Primary|12-month Composite Major Adverse Cardiac Event (MACE)||12 month|||participants|||Number
815174|NCT01089556|Other Pre-specified|Mean Change From Baseline to Week 8 Endpoint on the Neuropathic Pain Symptom Inventory (NPSI) Questionnaire|The NPSI is a 12-item self-administered questionnaire to assess 5 different dimensions of neuropathic pain: superficial spontaneous burning pain, deep spontaneous pressing pain, paroxysmal pain, evoked pains, and paresthesias/dysesthesias. A total score ranges from 0 to 100. Higher score indicates a greater intensity of pain. Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit and baseline*visit.|Baseline, Week 8|All randomized participants who received at least one dose of study drug, and had baseline and at least one post-baseline NPSI measurements during Weeks 1-8 (Study Period II).||units on a scale||95% Confidence Interval|Least Squares Mean
815175|NCT01089556|Secondary|Clinical Global Impression of Improvement (CGI-I) at Week 16 Endpoint|Measures clinician's perception of participant improvement at the time of assessment compared with the start of treatment for Study Period III. Scores range from 1 (very much better) to 7 (very much worse). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit, baseline*visit and treatment in Study Period II.|Week 16|All randomized participants who received at least one dose of study drug, and had at least one CGI-I measurement during Weeks 9-16 (Study Period III).||units on a scale||95% Confidence Interval|Least Squares Mean
815176|NCT01089556|Other Pre-specified|Clinical Global Impression of Improvement (CGI-I) at Week 8 Endpoint|Measures clinician's perception of participant improvement at the time of assessment compared with the start of treatment. Scores range from 1 (very much better) to 7 (very much worse). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, visit, and treatment*visit.|Week 8|All randomized participants who received at least one dose of study drug, and had at least one post-baseline CGI-I measurement during Weeks 1-8 (Study Period II).||units on a scale||95% Confidence Interval|Least Squares Mean
815177|NCT01089556|Secondary|Percentage of Participants With a Decrease of Greater Than or Equal to 2 Points on Brief Pain Inventory (BPI) Modified Short Form 24-Hour Average Pain Item Score at Week 16 Endpoint|BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Week 8 through Week 16|All randomized participants who received at least one dose of study drug, and had Week 8 and at least one BPI measurements during Weeks 9-16 (Study Period III). Last observation carried forward (LOCF) principle was used.||percentage of participants|||Number
815178|NCT01089556|Other Pre-specified|Percentage of Participants With a Decrease of Greater Than or Equal to 2 Points on Brief Pain Inventory (BPI) Modified Short Form 24-Hour Average Pain Item Score at Week 8 Endpoint|BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline through Week 8|All randomized participants who received at least one dose of study drug, and had baseline and at least one post-baseline BPI measurements during Weeks 1-8 (Study Period II). Last observation carried forward (LOCF) principle was used.||percentage of participants|||Number
815179|NCT01089556|Secondary|Percentage of Participants With a Reduction of Greater Than or Equal to 50% on Brief Pain Inventory (BPI) Modified Short Form 24-Hour Average Pain Item Score at Week 16 Endpoint|BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Week 8 through Week 16|All randomized participants who received at least one dose of study drug, and had Week 8 and at least one BPI measurements during Weeks 9-16 (Study Period III). Last observation carried forward (LOCF) principle was used.||percentage of participants|||Number
815180|NCT01089556|Other Pre-specified|Percentage of Participants With a Reduction of Greater Than or Equal to 50% on Brief Pain Inventory (BPI) Modified Short Form 24-Hour Average Pain Item Score at Week 8 Endpoint|BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline through Week 8|All randomized participants who received at least one dose of study drug, and had baseline and at least one post-baseline BPI measurements during Weeks 1-8 (Study Period II). Last observation carried forward (LOCF) principle was used.||percentage of participants|||Number
815181|NCT01089556|Secondary|Percentage of Participants With a Reduction of Greater Than or Equal to 30% on Brief Pain Inventory (BPI) Modified Short Form 24-Hour Average Pain Item Score at Week 16 Endpoint|BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Week 8 through Week 16|All randomized participants who received at least one dose of study drug, and had Week 8 and at least one BPI measurements during Weeks 9-16 (Study Period III). Last observation carried forward (LOCF) principle was used.||percentage of participants|||Number
815182|NCT01089556|Other Pre-specified|Percentage of Participants With a Reduction of Greater Than or Equal to 30% on Brief Pain Inventory (BPI) Modified Short Form 24-Hour Average Pain Item Score at Week 8 Endpoint|BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline through Week 8|All randomized participants who received at least one dose of study drug, and had baseline and at least one post-baseline BPI measurements during Weeks 1-8 (Study Period II). Last observation carried forward (LOCF) principle was used.||percentage of participants|||Number
815195|NCT01089582|Secondary|Change in ARICEPT Dosing: Number of Participants for Time to First ARICEPT Dose Escalation|The starting dose of ARICPET was 5 mg once daily (QD), which could be increased to 10 mg QD during the study.|Baseline to Week 12.|FAS. Starting dose of ARICEPT was not summarized.||participants|||Number
816935|NCT01116882|Primary|30-day Composite Major Adverse Cardiac Event (MACE)||30 days|The denominator for MACE at 30 days is defined as patients who either had MACE to 30d or had follow up of at least 23 days.||participants|||Number
815183|NCT01089556|Secondary|Mean Change From Week 8 to Week 16 Endpoint in Items of the Brief Pain Inventory (BPI) Modified Short Form Worst Pain Score|BPI Modified Short Form worst pain score is a self-reported scale that measures the severity of pain based on the worst pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit, baseline*visit and treatment in Study Period II.|Week 8, Week 16|All randomized participants who received at least one dose of study drug, and had Week 8 and at least one BPI measurements during Weeks 9-16 (Study Period III).||units on a scale||95% Confidence Interval|Least Squares Mean
815184|NCT01089556|Other Pre-specified|Mean Change From Baseline to Week 8 Endpoint in 24 Hour Average Pain Item Score on the Brief Pain Inventory (BPI) Modified Short Form|BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit and baseline*visit.|Baseline, Week 8|All randomized participants who received at least one dose of study drug, and had baseline and at least one post-baseline BPI measurements during Weeks 1-8 (Study Period II).||units on a scale||90% Confidence Interval|Least Squares Mean
815185|NCT01089556|Primary|Change From Week 8 to Week 16 Endpoint in 24 Hour Average Pain Item Score on the Brief Pain Inventory (BPI) Modified Short Form|BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit, baseline*visit and treatment in Study Period II.|Week 8, Week 16|All randomized participants who received at least one dose of study drug, and had Week 8 and at least one BPI measurements during Weeks 9-16 (Study Period III).||units on a scale||95% Confidence Interval|Least Squares Mean
815186|NCT01089569|Secondary|Change From Baseline in Weight Changes|"Measure the changes in weight attributable to exenatide, insulin glargine and their combinations.
Employ CGM with AGP analysis to determine if there is an incremental benefit for subjects who do not reach target to add exenatide to insulin glargine or insulin glargine to exenatide in patients taking metformin.
Change from baseline was calculated as weight in pounds at baseline minus weight in pounds at final visit (32 weeks)."|baseline - final visit (32 weeks)|||lbs (pounds)||Standard Deviation|Mean
815187|NCT01089569|Secondary|Change From Baseline in Glucose Exposure (Area Under the Diurnal Median Curve or AUC)|"Employ Continuous Glucose Monitoring (CGM) with Ambulatory Glucose Profile (AGP) analysis to characterize the diurnal patterns produced by oral medications (metformin) used in the treatment of type 2 diabetes.
Employ CGM to measure the effect of exenatide, insulin glargine and exenatide plus insulin glargine in terms of underlying physiological defects and alter medications in a manner that improves- i. Glucose exposure (area under the diurnal median curve) Change from baseline was calculated as area under the diurnal median curve at baseline minus AUC value at final visit (32 weeks).
AUC is calculated using modified rectangle method AUC = sum of superscript 23, subscript i=0 P subscript 50i I = hour of day P subscript 50i = smoother 50th percentile value for ith hour of day"|baseline - final visit (32 weeks)|||mg/dL*24hr||Standard Deviation|Mean
815188|NCT01089569|Secondary|Change From Baseline in CGM Glucose Variability|"Employ Continuous Glucose Monitoring (CGM) with Ambulatory Glucose Profile (AGP) analysis to characterize the diurnal patterns produced by oral medications (metformin) used in the treatment of type 2 diabetes.
Employ CGM to measure the effect of exenatide, insulin glargine and exenatide plus insulin glargine in terms of underlying physiological defects and alter medications in a manner that improves- ii. Glucose variability (inter-quartile range)
IQR is the difference between the 75th and 25th percentiles. Change from baseline was calculated as IQR at baseline minus IQR value at final visit (32 weeks)."|baseline to final visit (32 weeks)|||mg/dL||Standard Deviation|Mean
815189|NCT01089569|Secondary|Change From Baseline in Glucose Stability (Absolute Hourly Rate of Change in Median Curve)|"Employ Continuous Glucose Monitoring (CGM) with Ambulatory Glucose Profile (AGP) analysis to characterize the diurnal patterns produced by oral medications (metformin) used in the treatment of type 2 diabetes.
Employ CGM to measure the effect of exenatide, insulin glargine and exenatide plus insulin glargine in terms of underlying physiological defects and alter medications in a manner that improves iii. Glucose stability (absolute hourly rate of change in median curve)
Change from baseline was calculated as mean absolute hourly rate of change in median curve at baseline minus rate at final visit (32 weeks). Mean absolute hourly rate of change in the smoothed median curve is calculated as delta subscript MC = (|p subscript 50 zero - p subscript 50 23|+Sum superscript 23 subscript i = 1| p subscript 50i - p subscript 50 i-1| over T.
i = hour of day p subscript 50i = smoothed 50th percentile value for ith hour of day T = total # of non-missing hourly smoothed percentiles"|baseline to final visit (32 weeks)|||mg/dL/hr||Standard Deviation|Mean
815190|NCT01089569|Secondary|Change From Baseline in Incidence of Hypoglycemia (Degree)|"Employ Continuous Glucose Monitoring (CGM) with Ambulatory Glucose Profile (AGP) analysis to characterize the diurnal patterns produced by oral medications (metformin) used in the treatment of type 2 diabetes.
Employ CGM to measure the effect of exenatide, insulin glargine and exenatide plus insulin glargine in terms of underlying physiological defects and alter medications in a manner that improves- iv. Incidence of hypoglycemia (degree) Change from baseline was calculated as mean incidence percentage at baseline minus mean incidence percentage at final visit (32 weeks)"|baseline to final visit (32 weeks)|||percentage of measures under 70 mg/dL||Standard Deviation|Mean
815191|NCT01089569|Secondary|Change From Baseline in Incidence of Hypoglycemia (Frequency)|"Employ Continuous Glucose Monitoring (CGM) with Ambulatory Glucose Profile (AGP) analysis to characterize the diurnal patterns produced by oral medications (metformin) used in the treatment of type 2 diabetes.
Employ CGM to measure the effect of exenatide, insulin glargine and exenatide plus insulin glargine in terms of underlying physiological defects and alter medications in a manner that improves- iv. Incidence of hypoglycemia (frequency)
Change from baseline was calculated as mean incidence rate at baseline minus mean incidence rate at final visit (32 weeks)"|baseline to final visit (32 weeks)|||episodes/day||Standard Deviation|Mean
815196|NCT01089582|Primary|Change From Baseline in the Caregiver's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12|QoL-AD was comprised of 13 individual items, each measured on a 4-point Likert scale (ranging from 1 [poor] to 4 [excellent]). Overall QoL-AD score was the sum of the scores for the 13 individual items and ranged from 13 to 52, with higher scores indicating a higher health related quality of life.|Baseline, Week 12.|FAS; (n)=number of participants evaluable at baseline and Week 12.||scores on a scale||Standard Deviation|Mean
815197|NCT01089582|Primary|Change From Baseline in the Participant's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12|QoL-AD was comprised of 13 individual items, each measured on a 4-point Likert scale (ranging from 1 [poor] to 4 [excellent]). Overall QoL-AD score was the sum of the scores for the 13 individual items and ranged from 13 to 52, with higher scores indicating a higher health related quality of life.|Baseline, Week 12.|FAS; (n)=number of participants evaluable at baseline and Week 12.||scores on a scale||Standard Deviation|Mean
815198|NCT01089582|Primary|Number of Participants for Change From Baseline for the Caregiver's Assessment of Improvement at Week 12|The caregiver's assessment improvement was a 5-point rated scale ranging from much improved to much worse to the question ‘compared to the severity of your relative’s condition at baseline, how much do you feel it has changed?’.|Baseline, Week 12.|FAS.||participants|||Number
815199|NCT01089582|Primary|Number of Participants for Change From Baseline for Clinical Global Impressions of Improvement (CGI-I) at Week 12|CGI-I is a 7-point physician rated scale ranging from very much improved to very much worse.|Baseline, Week 12.|Full Analysis Set (FAS): all enrolled participants who received at least 1 dose (including partial doses) of ARICEPT.||participants|||Number
815200|NCT01089595|Secondary|Best Overall Response Using Response Evaluation Criteria in Solid Tumors, Choi Criteria, and Positron Emission Tomography Imaging||Every 8 weeks for up to 5 years|Too few participants to provide meaningful analysis||Participants|||Count of Participants
815201|NCT01089595|Primary|Progression Free Survival|Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression. It will be determined for both RECIST (Response Evaluation Criteria in Solid Tumors) and CHOI criteria.|6 months until death or for 5 years|||weeks||Standard Deviation|Mean
815202|NCT01089608|Primary|Visual Analogue Scale (VAS - Ranges 0-100 mm)|The primary objective is to evaluate the efficacy of the treatment by the change from baseline (Day 0) to Day 63 (± 3 Days) of the global ocular discomfort (Visual Analogue Scale) (Decrease of VAS value = better outcome)|Baseline and D63 (D63 minus baseline)|Modified ITT set: all randomised patients with at least one eligible treated eye, for whom any follow-up efficacy data are available.||units on a scale (from 0 to 100 mm)||95% Confidence Interval|Least Squares Mean
815203|NCT01089751|Secondary|Change From Baseline in Urgency Urinary Incontinence (UUI)|Urgency urinary incontinence is identified if the patient marks “Yes” for both Accidental Leakage and Urgency Associated Void in the 3-day bladder diary, and the Urgency Severity score is ≥ 1. Average daily episodes of UUI is calculated as the sum of all UUI episodes over 3-day diary period divided by the number of valid diary days with at least one valid bladder diary entry during the 3-day period. A negative change from Baseline indicated improvement.|Baseline, Week 14|Modified intent-to-treat population included all randomized participants who were incontinent at Baseline with at least one urinary episode marked “Yes” for both Accidental leakage and Urgency associated void, and an Urgency severity rating ≥ 1 in the bladder diary.||UUI episodes||Standard Deviation|Mean
815204|NCT01089751|Secondary|Change From Baseline in Urgency Severity|The urgency severity per toilet void is based on the Indevus Urgency Severity Scale (IUSS). The patient recorded urinary urgency severity in a 3-day bladder diary using a 4-point scale: 0=None-no urgency (best), 1=Slight-aware of urgency but is tolerable, 2=Moderate-urgency discomfort interferes with activities/tasks, 3=Severe-extreme urgency discomfort that abruptly stops activities/tasks (worst). Urgency Severity is calculated as the sum of all IUSS scores during the 3-day diary period divided by the number of toilet voids recorded during that period. A negative change from Baseline indicated improvement.|Baseline, Week 14|Modified intent-to-treat population included all randomized participants who were incontinent at Baseline with at least one urinary episode marked “Yes” for both Accidental leakage and Urgency associated void, and an Urgency severity rating ≥ 1 in the bladder diary.||Score on a scale||Standard Deviation|Mean
815205|NCT01089751|Secondary|Change From Baseline in Voided Volume|Average volume of urine voided per toilet void is calculated by total volume collected in a 24-hour diary period divided by the number of individual entries of volume voided in that period. A positive change from Baseline (greater volume voided) indicated improvement. A negative change from Baseline (less volume voided) indicated a worsening.|Baseline, Week 14|Modified intent-to-treat population included all randomized participants who were incontinent at Baseline with at least one urinary episode marked “Yes” for both Accidental leakage and Urgency associated void, and an Urgency severity rating ≥ 1 in the bladder diary.||cubic centimeters (cc)||Standard Deviation|Mean
815206|NCT01089751|Secondary|Change From Baseline in Daily Average Overactive Bladder-Symptom Composite Score (OAB-SCS)|The OAB-SCS is derived from the 3-day bladder diary which includes: 1) 24-hour voiding frequency; 2) the Indevus Urgency Severity Scale (IUSS) Score (0=no urgency, 1=aware of urgency but is tolerable, 2=urgency discomfort interferes with activities/tasks, 3=extreme urgency discomfort that abruptly stops activities/tasks associated with each toilet void); and 3) the frequency of Urgency Urinary Incontinence episodes. Each toilet void is then assigned a point value from 1 (IUSS Score=0) to 5 (UUI episode not associated with a toilet void). The daily average OAB-SCS is then calculated based on the diary entries and assigned point values. The lowest possible daily average OAB-SCS is 0 (corresponding to no urgency in every void). There is no upper limit since the score is based on the number of voids per day. Scores <= 30 indicate mild OAB, scores > 30 to 39 indicate moderate OAB, and scores >= 40 indicate severe OAB. A negative change from Baseline indicated improvement.|Baseline, Week 14|Modified intent-to-treat population included all randomized participants who were incontinent at Baseline with at least one urinary episode marked “Yes” for both Accidental leakage and Urgency associated void, and an Urgency severity rating ≥ 1 in the bladder diary.||Score on a scale||Standard Deviation|Mean
815260|NCT01097694|Secondary|Airway Wall Area|Change in airway wall area as assessed by computerized tomography (CT)|6 months after start of treatment|||% of area||Standard Deviation|Mean
815261|NCT01097694|Secondary|Airway Wall Thickness|Change in airway wall thickness as assessed by computerized tomography (CT)|6 months after start of treatment|||% of airway||Standard Deviation|Mean
815207|NCT01089751|Secondary|Change From Baseline in Urgency-Related Toilet Voids|Urgency-related toilet void (or urinary urgency) is identified if the patient marks “Yes” for both Urgency Association Void and Toilet Voiding in the 3-day bladder diary. The daily average number of urgency-related voids is calculated as the sum of all urgency episodes over the 3-day bladder diary period divided by the number of valid diary days with at least one valid bladder diary entry during the 3-day period. A negative change from Baseline (fewer urgency related toilet voids) indicated improvement.|Baseline, Week 14|Modified intent-to-treat population included all randomized participants who were incontinent at Baseline with at least one urinary episode marked “Yes” for both Accidental leakage and Urgency associated void, and an Urgency severity rating ≥ 1 in the bladder diary.||Toilet void||Standard Deviation|Mean
815208|NCT01089751|Secondary|Change From Baseline in Nocturic Toilet Voids|A nocturic (nighttime) toilet void is identified if the patient marks “Yes” for both Toilet Voiding and Sleep Interruption in the 3-day bladder diary. The daily average number of nocturic toilet voids is obtained as the sum of all nighttime toilet voids over the 3-day bladder diary period divided by number of valid diary days with at least one valid bladder diary entry during the 3-day period. A negative change from Baseline (fewer nocturic toilet voids) indicated improvement.|Baseline, Week 14|Modified intent-to-treat population included all randomized participants who were incontinent at Baseline with at least one urinary episode marked “Yes” for both Accidental leakage and Urgency associated void, and an Urgency severity rating ≥ 1 in the bladder diary.||Nocturic toilet void||Standard Deviation|Mean
815209|NCT01089751|Secondary|Change From Baseline in Continent Days Per Week (CDW)|Continent Days per Week is the average of the number of times an individual has no incontinence episodes in a day within the 3-day collection period calculated as 7 x (number of dry days within the 3-day diary period) divided by the number of valid diary days with at least one valid bladder diary entry during the 3-day period. A positive change from Baseline (more continent/fewer incontinent days per week ) indicated improvement.|Baseline, Week 14|Modified intent-to-treat population included all randomized participants who were incontinent at Baseline with at least one urinary episode marked “Yes” for both Accidental leakage and Urgency associated void, and an Urgency severity rating ≥ 1 in the bladder diary.||Continent days per week||Standard Deviation|Mean
815210|NCT01089751|Primary|Percentage of Patients Continent (PPC)|PPC is the percentage of patients with complete continence (without any urgency urinary incontinence episodes) during the 3-day bladder diary period associated with the Week 14 visit.|Week 14|Modified intent-to-treat population included all randomized participants who were incontinent at Baseline with at least one urinary episode marked “Yes” for both Accidental leakage and Urgency associated void, and an Urgency severity rating ≥ 1 in the bladder diary.||Percentage of participants|||Number
815211|NCT01097616|Secondary|Suvorexant LD Versus Placebo: Change From Baseline in LPS at Month 3|"LPS is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of time from the beginning of PSG assessment (Lights-Off) to the first interval of 10 consecutive minutes of sleep. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center."|Baseline and Month 3|Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. Only suvorexant LD-placebo comparison included, as suvorexant HD-placebo comparison is included in Primary hypothesis.||minutes||95% Confidence Interval|Least Squares Mean
815212|NCT01097616|Secondary|Suvorexant LD Versus Placebo: Change From Baseline in LPS at Month 1|"LPS is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of time from the beginning of PSG assessment (Lights-Off) to the first interval of 10 consecutive minutes of sleep. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center."|Baseline and Month 1|Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. Only suvorexant LD-placebo comparison included, as suvorexant HD-placebo comparison is included in Primary hypothesis.||minutes||95% Confidence Interval|Least Squares Mean
815213|NCT01097616|Secondary|Suvorexant LD/HD Versus Placebo: Change From Baseline in LPS at Night 1|"LPS is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of time from the beginning of PSG assessment (Lights-Off) to the first interval of 10 consecutive minutes of sleep. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center."|Baseline and Night 1|Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis.||minutes||95% Confidence Interval|Least Squares Mean
815214|NCT01097616|Primary|Number of Participants Who Discontinued Study Drug Due to an AE Occurring During Initial 3-Month DB TRT Phase|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Participants who discontinued study drug treatment due to an AE occurring during the initial 3-month DB TRT Phase are counted once in this summary.|Up to 3 months|All Patients as Treated (APaT) population, consisting of all randomized participants who received at least one dose of study medication||participants|||Number
815215|NCT01097616|Primary|Number of Participants With an Adverse Event (AE) During Initial 3-Month DB TRT Phase|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Participants with an AE occurring during the initial 3-month DB TRT Phase are counted once in this summary.|Up to 3 months|All Patients as Treated (APaT) population, consisting of all randomized participants who received at least one dose of study medication||participants|||Number
815262|NCT01097694|Secondary|Blood Eosinophils|Change in blood eosinophil count|6 months after start of treatment|||eosinophils per microliter||Standard Deviation|Mean
815216|NCT01097616|Secondary|Suvorexant LD Versus Placebo: Change From Baseline in sTSOm at Month 3|sTSOm is the average over a defined day range of the participant's report of the duration of time that it took to fall asleep, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Month 3 range is Days 76-90 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.|Baseline and Month 3|Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. Only suvorexant LD-placebo comparison included, as suvorexant HD-placebo comparison is included in Primary hypothesis.||minutes||95% Confidence Interval|Least Squares Mean
815217|NCT01097616|Secondary|Suvorexant LD Versus Placebo: Change From Baseline in sTSOm at Month 1|sTSOm is the average over a defined day range of the participant's report of the duration of time that it took to fall asleep, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Month 1 range is Days 23-30 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.|Baseline and Month 1|Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. Only suvorexant LD-placebo comparison included, as suvorexant HD-placebo comparison is included in Primary hypothesis.||minutes||95% Confidence Interval|Least Squares Mean
815218|NCT01097616|Secondary|Suvorexant LD/HD Versus Placebo: Change From Baseline in sTSOm at Week 1|sTSOm is the average over a defined day range of the participant's report of the duration of time that it took to fall asleep, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Week 1 range is Days 2-8 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.|Baseline and Week 1|Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis.||minutes||95% Confidence Interval|Least Squares Mean
815219|NCT01097616|Secondary|Suvorexant LD Versus Placebo: Change From Baseline in WASO at Month 3|"WASO is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center."|Baseline and Month 3|Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. Only suvorexant LD-placebo comparison included, as suvorexant HD-placebo comparison is included in Primary hypothesis.||minutes||95% Confidence Interval|Least Squares Mean
815220|NCT01097616|Secondary|Suvorexant LD Versus Placebo: Change From Baseline in WASO at Month 1|"WASO is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center."|Baseline and Month 1|Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. Only suvorexant LD-placebo comparison included, as suvorexant HD-placebo comparison is included in Primary hypothesis.||minutes||95% Confidence Interval|Least Squares Mean
815221|NCT01097616|Secondary|Suvorexant LD/HD Versus Placebo: Change From Baseline in WASO at Night 1|"WASO is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center."|Baseline and Night 1|Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis.||minutes||95% Confidence Interval|Least Squares Mean
815222|NCT01097616|Secondary|Suvorexant LD Versus Placebo: Change From Baseline in sTSTm at Month 3|sTSTm is the average over a defined day range of the participant's report of the total amount of time spent asleep before waking for the day, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Month 3 range is Days 76-90 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.|Baseline and Month 3|Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. Only suvorexant LD-placebo comparison included, as suvorexant HD-placebo comparison is included in Primary hypothesis.||minutes||95% Confidence Interval|Least Squares Mean
816936|NCT01116921|Secondary|Incidence of Chronic Lung Disease||Measured at hospital discharge|||Participants|||Count of Participants
815223|NCT01097616|Secondary|Suvorexant LD Versus Placebo: Change From Baseline in sTSTm at Month 1|sTSTm is the average over a defined day range of the participant's report of the total amount of time spent asleep before waking for the day, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Month 1 range is Days 23-30 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.|Baseline and Month 1|Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. Only suvorexant LD-placebo comparison included, as suvorexant HD-placebo comparison is included in Primary hypothesis.||minutes||95% Confidence Interval|Least Squares Mean
815224|NCT01097616|Secondary|Suvorexant LD/HD Versus Placebo: Change From Baseline in sTSTm at Week 1|sTSTm is the average over a defined day range of the participant's report of the total amount of time spent asleep before waking for the day, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Week 1 range is Days 2-8 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.|Baseline and Week 1|Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis.||minutes||95% Confidence Interval|Least Squares Mean
815225|NCT01097616|Primary|Suvorexant HD Versus Placebo: Change From Baseline in LPS at Month 3|"LPS is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of time from the beginning of PSG assessment (Lights-Off) to the first interval of 10 consecutive minutes of sleep. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center."|Baseline and Month 3|Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. The Primary hypothesis included only the suvorexant HD-placebo comparison.||minutes||95% Confidence Interval|Least Squares Mean
815226|NCT01097616|Primary|Suvorexant HD Versus Placebo: Change From Baseline in Latency to Onset of Persistent Sleep (LPS) at Month 1|"LPS is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of time from the beginning of PSG assessment (Lights-Off) to the first interval of 10 consecutive minutes of sleep. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center."|Baseline and Month 1|Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. The Primary hypothesis included only the suvorexant HD-placebo comparison.||minutes||95% Confidence Interval|Least Squares Mean
815227|NCT01097616|Primary|Suvorexant HD Versus Placebo: Change From Baseline in sTSOm at Month 3|sTSOm is the average over a defined day range of the participant's report of the duration of time that it took to fall asleep, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Month 3 range is Days 76-90 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.|Baseline and Month 3|Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. The Primary hypothesis included only the suvorexant HD-placebo comparison.||minutes||95% Confidence Interval|Least Squares Mean
815228|NCT01097616|Primary|Suvorexant HD Versus Placebo: Change From Baseline in Mean Subjective Time to Sleep Onset (sTSOm) at Month 1|sTSOm is the average over a defined day range of the participant's report of the duration of time that it took to fall asleep, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Month 1 range is Days 23-30 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.|Baseline and Month 1|Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. The Primary hypothesis included only the suvorexant HD-placebo comparison.||minutes||95% Confidence Interval|Least Squares Mean
815229|NCT01097616|Primary|Suvorexant HD Versus Placebo: Change From Baseline in WASO at Month 3|"WASO is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center."|Baseline and Month 3|Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. The Primary hypothesis included only the suvorexant HD-placebo comparison.||minutes||95% Confidence Interval|Least Squares Mean
815263|NCT01097694|Secondary|Endobronchial Biopsy Smooth Muscle Tryptase-positive Mast Cells|Change in the biopsy smooth muscle tryptase-positive mast cells from baseline at 6 months|6 months after start of treatment|||mast cells per mm2||Standard Deviation|Mean
815230|NCT01097616|Primary|Suvorexant HD Versus Placebo: Change From Baseline in Wakefulness After Persistent Sleep Onset (WASO) at Month 1|"WASO is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center."|Baseline and Month 1|Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. The Primary hypothesis included only the suvorexant HD-placebo comparison.||minutes||95% Confidence Interval|Least Squares Mean
815231|NCT01097616|Primary|Suvorexant HD Versus Placebo: Change From Baseline in sTSTm at Month 3|sTSTm is the average over a defined day range of the participant's report of the total amount of time spent asleep before waking for the day, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Month 3 range is Days 76-90 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.|Baseline and Month 3|Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. The Primary hypothesis included only the suvorexant HD-placebo comparison.||minutes||95% Confidence Interval|Least Squares Mean
815232|NCT01097616|Primary|Suvorexant HD Versus Placebo: Change From Baseline in Mean Subjective Total Sleep Time (sTSTm) at Month 1|sTSTm is the average over a defined day range of the participant's report of the total amount of time spent asleep before waking for the day, as recorded in a daily electronic diary (e-diary). Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any polysomnography [PSG] nights) falling within the day range; Month 1 range is Days 23-30 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.|Baseline and Month 1|Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. The Primary hypothesis included only the suvorexant HD-placebo comparison.||minutes||95% Confidence Interval|Least Squares Mean
815233|NCT01097629|Primary|Number of Participants Who Discontinued Study Drug Due to an AE Occurring During 3-Month DB TRT Phase|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Participants who discontinued study drug treatment due to an AE occurring during the 3-month DB TRT Phase are counted once in this summary.|Up to 3 months|All Patients as Treated (APaT) population, consisting of all randomized participants who received at least one dose of study medication||participants|||Number
815234|NCT01097629|Primary|Number of Participants With an Adverse Event (AE) During 3-Month DB TRT Phase|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Participants with an AE occurring during the 3-month DB TRT Phase are counted once in this summary.|Up to 3 months|All Patients as Treated (APaT) population, consisting of all randomized participants who received at least one dose of study medication||participants|||Number
815235|NCT01097629|Secondary|Suvorexant HD Versus Placebo: Change From Baseline in LPS at Night 1|"LPS is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of time from the beginning of PSG assessment (Lights-Off) to the first interval of 10 consecutive minutes of sleep. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center."|Baseline and Night 1|Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. The hypothesis included only the suvorexant HD-placebo comparison.||minutes||95% Confidence Interval|Least Squares Mean
815236|NCT01097629|Secondary|Suvorexant HD Versus Placebo: Change From Baseline in sTSOm at Week 1|sTSOm is the average over a defined day range of the participant's report of the duration of time that it took to fall asleep, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Week 1 range is Days 2-8 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.|Baseline and Week 1|Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. The hypothesis included only the suvorexant HD-placebo comparison.||minutes||95% Confidence Interval|Least Squares Mean
815237|NCT01097629|Secondary|Suvorexant HD Versus Placebo: Change From Baseline in WASO at Night 1|"WASO is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center."|Baseline and Night 1|Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. The hypothesis included only the suvorexant HD-placebo comparison.||minutes||95% Confidence Interval|Least Squares Mean
815238|NCT01097629|Secondary|Suvorexant HD Versus Placebo: Change From Baseline in sTSTm at Week 1|sTSTm is the average over a defined day range of the participant's report of the total amount of time spent asleep before waking for the day, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Week 1 range is Days 2-8 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.|Baseline and Week 1|Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. The hypothesis included only the suvorexant HD-placebo comparison.||minutes||95% Confidence Interval|Least Squares Mean
815239|NCT01097629|Primary|Suvorexant HD Versus Placebo: Change From Baseline in LPS at Month 3|"LPS is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of time from the beginning of PSG assessment (Lights-Off) to the first interval of 10 consecutive minutes of sleep. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center."|Baseline and Month 3|Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. The hypothesis included only the suvorexant HD-placebo comparison.||minutes||95% Confidence Interval|Least Squares Mean
815240|NCT01097629|Primary|Suvorexant HD Versus Placebo: Change From Baseline in Latency to Onset of Persistent Sleep (LPS) at Month 1|"LPS is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of time from the beginning of PSG assessment (Lights-Off) to the first interval of 10 consecutive minutes of sleep. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center."|Baseline and Month 1|Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. The hypothesis included only the suvorexant HD-placebo comparison.||minutes||95% Confidence Interval|Least Squares Mean
815241|NCT01097629|Primary|Suvorexant HD Versus Placebo: Change From Baseline in sTSOm at Month 3|sTSOm is the average over a defined day range of the participant's report of the duration of time that it took to fall asleep, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Month 3 range is Days 76-90 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.|Baseline and Month 3|Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. The hypothesis included only the suvorexant HD-placebo comparison.||minutes||95% Confidence Interval|Least Squares Mean
815242|NCT01097629|Primary|Suvorexant HD Versus Placebo: Change From Baseline in Mean Subjective Time to Sleep Onset (sTSOm) at Month 1|sTSOm is the average over a defined day range of the participant's report of the duration of time that it took to fall asleep, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Month 1 range is Days 23-30 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.|Baseline and Month 1|Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. The hypothesis included only the suvorexant HD-placebo comparison.||minutes||95% Confidence Interval|Least Squares Mean
815243|NCT01097629|Primary|Suvorexant HD Versus Placebo: Change From Baseline in WASO at Month 3|"WASO is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center."|Baseline and Month 3|Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. The hypothesis included only the suvorexant HD-placebo comparison.||minutes||95% Confidence Interval|Least Squares Mean
815244|NCT01097629|Primary|Suvorexant HD Versus Placebo: Change From Baseline in Wakefulness After Persistent Sleep Onset (WASO) at Month 1|"WASO is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center."|Baseline and Month 1|Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. The hypothesis included only the suvorexant HD-placebo comparison.||minutes||95% Confidence Interval|Least Squares Mean
815264|NCT01097694|Secondary|Endobronchial Biopsy Total Tryptase-positive Mast Cells|Change in endobronchial biopsy total tryptase-positive mast cells from baseline at 6 months|6 months after start of treatment|||mast cells per mm2||Standard Deviation|Mean
815245|NCT01097629|Primary|Suvorexant HD Versus Placebo: Change From Baseline in sTSTm at Month 3|sTSTm is the average over a defined day range of the participant's report of the total amount of time spent asleep before waking for the day, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Month 3 range is Days 76-90 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.|Baseline and Month 3|Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. The hypothesis included only the suvorexant HD-placebo comparison.||minutes||95% Confidence Interval|Least Squares Mean
815246|NCT01097629|Primary|Suvorexant HD Versus Placebo: Change From Baseline in Mean Subjective Total Sleep Time (sTSTm) at Month 1|sTSTm is the average over a defined day range of the participant's report of the total amount of time spent asleep before waking for the day, as recorded in a daily electronic diary (e-diary). Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any polysomnography [PSG] nights) falling within the day range; Month 1 range is Days 23-30 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.|Baseline and Month 1|Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. The hypothesis included only the suvorexant HD-placebo comparison.||minutes||95% Confidence Interval|Least Squares Mean
815247|NCT01097655|Other Pre-specified|Prevalence of Adverse Events (Weeks 0-144), Per Participant|Percentage of participants who experienced at least 1 adverse event during Weeks 0-144 by adverse event type. Doctors asked participants for adverse events, grouped them into categories given in the eCRF. The list of adverse events included in the eCRF were hypertriglyceridemia, hypercholesterolemia, low HDL cholesterol, high LDL cholesterol, hyperglycemia, hyperbilirubinemia, elevated AST, elevated ALT, elevated γGT, elevated alkaline phosphatase, stomatitis, nausea, vomiting, diarrhea, abdominal pain, mood disorder, neurocerebellar disorder, neurocontrol disorder, headache, fatigue, fever, other (listed as 'not specified').|Weeks 0 to 144|||percentage of participants|||Number
815248|NCT01097655|Other Pre-specified|Prevalence of Adverse Events (Weeks 0-144), Per Event|Percentage of overall number of adverse events experienced during Weeks 0-144 by adverse event type. Doctors asked participants for adverse events, grouped them into categories given in the electronic case report form (eCRF). The list of adverse events included in the eCRF were hypertriglyceridemia, hypercholesterolemia, low high density lipoprotein (HDL) cholesterol, high low density lipoprotein (LDL) cholesterol, hyperglycemia, hyperbilirubinemia, elevated aspartate aminotransferase (AST), elevated alanine aminotransferase (ALT), elevated gamma glutamyl transferase (γGT), elevated alkaline phosphatase, stomatitis, nausea, vomiting, diarrhea, abdominal pain, mood disorder, neurocerebellar disorder, neurocontrol disorder, headache, fatigue, fever, other (listed as 'not specified').|Weeks 0 to 144|||percentage of adverse events|Adverse Events||Number
815249|NCT01097655|Primary|Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load|Changes in participants' HIV-1 RNA viral load were assessed by measuring the change from Baseline at scheduled visits planned as part of routine care.|Baseline (Week 0) to Week 144|Participants with an assessment at Baseline. Number analyzed=participants with an assessment at given time point.||log copies/mL||Standard Deviation|Mean
815250|NCT01097655|Primary|Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count|Changes in participants' CD4 cell counts were assessed by measuring the change from Baseline in the number of CD4 cells at scheduled visits planned as part of routine care.|Baseline (Week 0) to Week 144|Participants with an assessment at Baseline. Number analyzed=participants with an assessment at given time point.||cells/μL||Standard Deviation|Mean
815251|NCT01097668|Secondary|The Effect of ATX-MS-1467 on Brain Magnetic Resonance Imaging (MRI).|Number of new or persisting Gadolinium-enhancing lesions at week 16 and 20 when compared to baseline.|16 and 20 weeks|ITT population at week 16 and 20 n=21 (Intradermal injection) ITT population at week 16 and 20 n=22 (Subcutaneous injection) MRI population at week 16 and 20 n=17 (Intradermal injection) MRI population at week 16 and 20 n=20 (Subcutaneous injection)||MRI lesions||95% Confidence Interval|Mean
815252|NCT01097668|Primary|Safety and Tolerability|Occurrence of treatment emergent Adverse Events (AE), Serious Adverse Events, and laboratory abnormalities up to week 48 compared to baseline.|48 weeks|The Safety population will be denoted as the ‘ITT population’ for the summarisation of safety endpoints.||participants|||Number
815253|NCT01097694|Secondary|Change in Number of Self-Reported Asthma Symptom Free Days||baseline to week 24|Self-reported asthma symptom free days were not entered into the study database.|||||
815254|NCT01097694|Secondary|Change in Inflammatory Mediators in Exhaled Breath Condensate|Assessment of change in eicosanoids in the exhaled breath condensate|baseline to week 24|The exhaled breath condensate was not processed for inflammatory mediators.|||||
815255|NCT01097694|Secondary|Change in Sputum Supernatant Differential, Supernatant Tryptase and IL-13|Change in sputum eosinophil and neutrophil percentage. Change in sputum supernatant tryptase as measured by ELISA. Change in sputum IL-13 level as measured by ELISA.|baseline to 24 weeks|"Sputum sample slide preparation quality was poor and samples meeting quality control were insufficient for analysis of sputum differential.
Insufficient study funds prevented assessment of sputum tryptase. IL-13 was below the detection limit of assay in sputum supernatant."|||||
815256|NCT01097694|Secondary|Urinary Leukotriene E4|Change in urinary leukotriene E4 levels from baseline|6 months after start of treatment|||ng/mg Creatinine||Standard Deviation|Mean
815257|NCT01097694|Secondary|Bronchoalveolar Lavage Cysteinyl Leukotrienes|Change in bronchoalveolar lavage cysteinyl leukotrienes levels from baseline|6 months after start of treatment|||pg/mL||Standard Deviation|Mean
815258|NCT01097694|Secondary|Urinary Prostaglandin D2|Change in urinary Prostaglandin D2 levels from baseline|6 months after start of treatment|||ng/mg Creatinine||Standard Deviation|Mean
815259|NCT01097694|Secondary|Bronchoalveolar Lavage Histamine|Change in bronchoalveolar lavage histamine levels from baseline|6 months after start of treatment|||nM||Standard Deviation|Mean
815269|NCT01097694|Secondary|Asthma Quality of Life Questionnaire (AQLQ)|Change in patient-reported Asthma Quality of Life Questionnaire (AQLQ) score The asthma quality of life questionnaire (AQLQ) is a 32-item scale with a range from 1-7 with a higher value denoting improvement. The minimal important difference is 0.5.|6 months after start of treatment|||units on a scale||Standard Deviation|Mean
815270|NCT01097694|Secondary|Asthma Control Questionnaire (ACQ)|Change in patient-reported ACQ score The six-item Asthma Control Questionnaire (ACQ-6) is a scale from 0 to 6 with a lower value denoting an improvement in asthma control. The minimal important difference is 0.5.|6 months after start of treatment|||units on a scale||Standard Deviation|Mean
815271|NCT01097694|Secondary|Fractional Exhaled Nitric Oxide (FeNO)|Change in Fractional Exhaled Nitric Oxide Measurement (ppb)|6 months after start of treatment|||parts per billion||Standard Deviation|Mean
815272|NCT01097694|Secondary|Evening Peak Flow|Change in patient-reported evening peak flow measurement (L/s)|6 months after start of treatment|||L/second||Standard Deviation|Mean
815273|NCT01097694|Secondary|Morning Peak Flow Measurement|Change in patient-reported morning peak flow measurement (L/s)|6 months after start of treatment|||L/second||Standard Deviation|Mean
815274|NCT01097694|Secondary|FEV1%|Change in FEV1% of predicted|6 months after start of treatment|||% of predicted||Standard Deviation|Mean
815275|NCT01097694|Secondary|FEV1 in Liters|Change in FEV1 in treatment group compared to placebo group|6 months after start of treatment|||L||95% Confidence Interval|Mean
815276|NCT01097694|Secondary|Number of Asthma Exacerbations|Number of asthma exacerbations experienced from randomization to study completion.|Up to 24 weeks|||events|||Number
815277|NCT01097694|Secondary|Change in Maximum Post-Bronchodilator (BD) Forced Expiratory Volume in One Second (FEV1) %||6 months after start of treatment|||% of predicted||Standard Deviation|Mean
815278|NCT01097694|Secondary|Bronchoalveolar Lavage (BAL) Fluid Tryptase Level|Change in BAL fluid tryptase levels after 24 weeks of imatinib vs. placebo|6 months after start of treatment|||ng/mL||Standard Deviation|Mean
815279|NCT01097694|Secondary|Serum Total Tryptase|Change in serum total tryptase after 24 weeks of imatinib vs placebo treatment|6 months after start of treatment|||ng/ml||Standard Deviation|Mean
815280|NCT01097694|Primary|Change in Mean Methacholine Responsiveness as Assessed by the Provocation Concentration Causing a 20% Fall in Forced Expiratory Volume in One Second (FEV1) (PC20) at Month 3 and 6 Versus Baseline|"Our primary outcome was change in airway hyperresponsiveness, as assessed by PC20, from baseline to 3 and/or 6 months of therapy in imatinib treated participants as compared with controls. Change in PC20 was assessed using log2-transformed ratios of PC20 at month 3 and /or month 6 vs PC20 at baseline. Our null hypothesis was that the mean of this ratio will be 0 after log2-transformed. We used a linear mixed-effects model for a repeated-measures analysis to compare the primary outcome between the two groups.
PC20 is determined by the provocation concentration of methacholine causing a 20% fall in forced expiratory volume in one second (FEV1)."|Over 6 months from beginning of treatment|||Log2 Ratio||Standard Deviation|Mean
815281|NCT01097785|Secondary|Change in Measures of Reactive Oxygen Species in the Blood|Reactive Oxygen Species will be assessed after one month of placebo and statin therapy; measured using electron parametric resonance spectroscopy (EPR).|Baseline and 30 days|||EPR Arbitrary Units||Standard Error|Mean
815282|NCT01097785|Primary|Change in Muscle Sympathetic Nerve Activity in Bursts Per 100 Heartbeats|Muscle sympathetic nerve activity will be assessed after one month of placebo and statin therapy; measured in bursts/100 heartbeats.|Baseline and 30 days|||bursts/100 heartbeats||Standard Error|Mean
815283|NCT01097863|Primary|Visibility of the Inversion Indicator on Lens When Lens Was on Participant's Finger, for Example, During Lens Insertion.|"As assessed by the participant retrospectively after one week of wear and recorded on a questionnaire as a yes or no response to the question, Did you notice an OK mark on the study lens while it was on your finger, for example, during lens insertion? The positive yes responses are reported."|1 week|Analysis conducted per protocol, with exclusions due to protocol deviations as determined by masked review (9), and unavailable data due to discontinuations (3).||participants|||Number
815284|NCT01098032|Secondary|The Cost-effectiveness Ratio.|Assessement of the cost-effectiveness ratio is important when testing a new strategy of both therapy and prophylaxis. The Renalguard system is more expensive than the conventional hydration regimen. The cost of RenalGuard system is approximately 800 $. This cost will be justified only if the system is more effective in preventing CI-AKI and improving the clinical outcome, expecially reducing the lenght of ospedalization and the rate of dialysis.|1 month||||||
815285|NCT01098032|Secondary|The Rate of In-hospital Major Adverse Events (i.e. Acute Myocardial Infarction, c) Renal Failure Requiring Dialysis, and d) Acute Pulmonary Edema)|Assessment of the rate of in-hospital major adverse events (i.e. acute myocardial infarction, c) renal failure requiring dialysis, and d) acute pulmonary edema) will give important informantion on the clinical relevance of prophylactic strategies in preventing CI-AKI|1 month||||||
815286|NCT01098032|Secondary|the Rate of Acute Renal Failure Requiring Dialysis|occurrence of renal failure requiring dialysis represents the haard endpoint of the study. Actually this represents the worst clinical consequence of CI-AKI.|1 month||||||
815287|NCT01098032|Secondary|Changes in the Urine and Serum NGAL Concentration After Contrast Exposure|NGAL is a new biomarker which seems to be very promising in detecting kidney injury. prelimiary data suggest that urine and serum NGAL increase very early (within few horurs) after the occurrence og acute kidney damage. Therefore, NGAL may be a real marker of acute kidney injury.|7 days||||||
815288|NCT01098032|Secondary|Changes in the Serum Cystatin C Concentration at 24 and 48 Hours After Contrast Exposure|Cystatin C is an alternative biomarker of kidney damage. Cystatin C seems to be superior to serum creatinine an identifying kidney function and damage.|7 days||||||
815289|NCT01098032|Secondary|Rate of Kidney Injury and Major Adverse Events|an increase in the serum creatinine concentration >=0.25% and >=0.5 mg/dl at 48 hours after contrast exposure|7 days||||||
815306|NCT01098110|Secondary|Change From Baseline in Clinical Global Impressions -Severity of Illness (CGI-S) Score.|The CGI-S is a score that measures the severity of overall bipolar illness. The score ranges on a scale from 1 to 7, where 1 is normal, and 7 is very severely ill. Change from baseline values that are negative represent an improvement in symptoms.|Baseline and Day 42|All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. Dropout or missing data are imputed by the LOCF method.||Score on a scale||95% Confidence Interval|Least Squares Mean
815290|NCT01098032|Primary|Number of Participants With Contrast-induced Acute Kidney Injury|The primary outcome measure will be the rate of development of CI-AKI in the 2 study arms (number of participants). CI-AKI is defined as an increase in the serum creatinine concentration >=0.3 mg/dL from the baseline value at 48 hours after administration of the contrast media or the need for dialysis.|at 48 hours following contrast exposure|all consecutive patients with chronic kidney disease scheduled for coronary and/or peripheral angiography and/or angioplasty with an estimated glomerular filtration rate (eGFR) ≤30 ml/min/1.73 m2 and/or a risk score ≥11 were considered eligible for the study||participants|||Number
815299|NCT01098097|Secondary|Proportion of Participants Who Achieve Undetectable Hepatitis C Virus Ribonucleic Acid (HCV-RNA)|Participant's blood was tested for HCV-RNA by quantitative polymerase chain reaction. The limit of detection for the assay was 50 IU/mL.|Week 12|The population analyzed was 920 participants who received at least 1 dose of study drug and had data collected at the Week 12 visit||percentage of participants||95% Confidence Interval|Number
815300|NCT01098097|Primary|Incidence of Dose Modifications Due to Adverse Events|All dose modifications due to an AE were reported. See Outcome Measure 1 for definition of AEs.|Up to 12 Weeks|||percentage of participants|||Number
815301|NCT01098097|Primary|Incidence of Particular Adverse Events Resulting in Treatment Discontinuation|"All treatment discontinuations due to particular AEs were reported. These discontinuations included treatment stopped (TS) and dose reduced followed by treatment stopped (DR/TS).
The particular AE evaluated were anemia (low red blood cells), leucopenia (low white blood cells), neutropenia (low blood neutrophils), thrombocytopenia (low blood platelets), esophageal varices (dilated veins in lower esophagus), splenomegaly (enlarged spleen), portal hypertensive gastropathy (changes in stomach mucosa), and hepatomegaly (enlarged liver)"|Up to 12 Weeks|||percentage of participants|||Number
815302|NCT01098097|Primary|Incidence of Treatment Discontinuations Due to Adverse Events|All treatment discontinuations due to an AE were reported. See Outcome Measure 1 for definition of AEs.|Up to 12 Weeks|||percentage of participants|||Number
815303|NCT01098097|Primary|Incidence of Thrombocytopenia|Thrombocytopenia is a low blood platelet count|Up to 12 Weeks|||percentage of participants|||Number
815304|NCT01098097|Primary|Incidence of Serious Adverse Events (SAEs) and/or Clinically Significant Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant administered a medicinal product which did not necessarily have a causal relationship to the treatment. All AEs reported in the study were judged by the investigator to be clinically significant. An SAE was any adverse drug experience that resulted in death, was life-threatening, caused or prolonged hospitalization, caused persistent or significant disability or incapacity, caused a congenital anomaly or birth defect, or may have required medical or surgical intervention to prevent one of these outcomes.|Up to 12 Weeks|||percentage of participants|||Number
815305|NCT01098110|Secondary|Percentage of Participants Who Were Clinical Global Impressions - Improvement (CGI-I) Responders.|The CGI-I is a score on a 7-point scale for assessing the change from preceding phase of overall symptoms of bipolar disorder during the treatment of an acute episode or in longer term illness prophylaxis. Compared to the baseline, the CGI-I score ranges from 1 = very much improved since initiating treatment, to 7 = very much worse since initiating treatment. The CGI-I score was assessed at baseline and Day 42. Compared to the baseline measurement, a CGI-I responder had a score at Day 42 of 3 (minimally improved), 2 (much improved) or 1 (very much improved).|Day 42|All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. Dropout or missing data are imputed by the LOCF method.||Percentage of participants||95% Confidence Interval|Number
815307|NCT01098110|Secondary|Percentage of Participants Who Were PANSS Responders.|PANSS total score measures symptoms of schizophrenia and consists of responses to 30 items: 7 items from the positive subscale (P1-P7), 7 items from the negative subscale (N1-N7) and 16 items from the general psychopathology subscale (G1-G16). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS total score is the sum of the scores for all 30 items, and ranges from 30 to 210, with a higher score indicating greater severity of symptoms. The PANSS total score was determined at baseline and then at Day 42, and a participant with a 30% or greater reduction from baseline in PANSS total score at Day 42 was considered a PANSS responder.|Day 42|All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. Dropout or missing data are imputed by the LOCF method.||Percentage of participants||95% Confidence Interval|Number
815308|NCT01098110|Secondary|Change From Baseline in PANSS Marder Factor Anxiety/Depression Symptom Score.|PANSS Marder Factor Anxiety/Depression symptom score measures symptoms of schizophrenia and consists of responses to 4 items (G2,G3,G4,G6). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Anxiety/Depression symptom score is the sum of the scores for all 4 items and ranges from 4 to 28, with a higher score indicating greater severity of symptoms. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 42|All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. Dropout or missing data are imputed by the LOCF method.||Score on a scale||95% Confidence Interval|Least Squares Mean
815309|NCT01098110|Secondary|Change From Baseline in PANSS Marder Factor Hostility/Excitement Symptom Score.|PANSS Marder Factor Hostility/Excitement symptom score measures symptoms of schizophrenia and consists of responses to 4 items (P4,P7,G8,G14). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Hostility/Excitement symptom score is the sum of the scores for all 4 items and ranges from 4 to 28, with a higher score indicating greater severity of symptoms. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 42|All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. Dropout or missing data are imputed by the LOCF method||Score on a scale||95% Confidence Interval|Least Squares Mean
815310|NCT01098110|Secondary|Change From Baseline in PANSS Marder Factor Disorganized Thought Symptom Score.|PANSS Marder Factor Disorganized Thought symptom score measures symptoms of schizophrenia and consists of responses to 7 items (P2,N5,G5,G10,G11,G13,G15). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Disorganized Thought symptom score is the sum of the scores for all 7 items and ranges from 7 to 49, with a higher score indicating greater severity of symptoms. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 42|All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. One participant from the 5 mg BID arm was missing a post-baseline measurement. Dropout or missing data are imputed by the LOCF method.||Score on a scale||95% Confidence Interval|Least Squares Mean
815311|NCT01098110|Secondary|Change From Baseline in PANSS Marder Factor Negative Symptom Score.|PANSS Marder Factor Negative symptom score measures symptoms of schizophrenia and consists of responses to 7 items (N1,N2,N3,N4,N6,G7,G16). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Negative symptom score is the sum of the scores for all 7 items and ranges from 7 to 49, with a higher score indicating greater severity of symptoms. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 42|All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. Dropout or missing data are imputed by the LOCF method.||Score on a scale||95% Confidence Interval|Least Squares Mean
815312|NCT01098110|Secondary|Change From Baseline in PANSS Marder Factor Positive Symptom Score.|PANSS Marder Factor Positive symptom score measures symptoms of schizophrenia and consists of responses to 8 items (P1,P3,P5,P6,N7,G1,G9,G12). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Positive symptom score is the sum of the scores for all 8 items and ranges from 8 to 56, with a higher score indicating greater severity of symptoms. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 42|All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. Dropout or missing data are imputed by the LOCF method.||Score on a scale||95% Confidence Interval|Least Squares Mean
815313|NCT01098110|Secondary|Change From Baseline in PANSS General Psychopathology Score.|PANSS General Psychopathology subscale measures symptoms of schizophrenia and consists of responses to 16 items (G1-G16). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS General Psychopathology subscale is the sum of the scores for all 16 items and ranges from 16 to 112, with a higher score indicating greater severity of symptoms.. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 42|All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. Dropout or missing data are imputed by the LOCF method.||Score on a scale||95% Confidence Interval|Least Squares Mean
815314|NCT01098110|Secondary|Change From Baseline in PANSS Negative Symptom Score.|PANSS Negative subscale measures symptoms of schizophrenia and consists of responses to 7 items (N1-N7). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Negative subscale sums all 7 items and ranges from 7 to 49, with a higher score indicating greater severity of symptoms. . An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 42|All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. One participant from the 5 mg BID arm was missing a post-baseline measurement. Dropout or missing data are imputed by the LOCF method.||Score on a scale||95% Confidence Interval|Least Squares Mean
815497|NCT01100073|Primary|Change From Baseline in Spiralometry Measurement at the End of Maintenance (Right Hand)|Change (reduction) in tremor amplitude from baseline to end of study for the right hand|Week 0 to weeks 9-16 (Visit 3)|Full analysis set (FAS) - Patients for whom baseline and end of study spiralometry measurement (right hand) available||millimeters of tremor amplitude||Standard Deviation|Mean
815315|NCT01098110|Secondary|Change From Baseline in PANSS Positive Symptom Score.|PANSS Positive subscale measures symptoms of schizophrenia and consists of responses to 7 items (P1-P7). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Positive subscale sums all 7 items and ranges from 7 to 49, with a higher score indicating greater severity of symptoms. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 42|All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. Dropout or missing data are imputed by the LOCF method.||Score on a scale||95% Confidence Interval|Least Squares Mean
815316|NCT01098110|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score.|PANSS total score measures symptoms of schizophrenia and consists of responses to 30 items: 7 items from the positive subscale (P1-P7), 7 items from the negative subscale (N1-N7) and 16 items from the general psychopathology subscale (G1-G16). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS total score is the sum of the scores for all 30 items, and ranges from 30 to 210, with a higher score indicating greater severity of symptoms. Change from baseline values that are negative represent an improvement in symptoms.|Baseline and Day 42|All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. Dropout or missing data are imputed by the last observation carried forward (LOCF) method.||Score on a scale||95% Confidence Interval|Least Squares Mean
815317|NCT01098162|Secondary|Incidence of Adverse Events During the Study|The number of subjects affected by any Treatment Emergent Adverse Event (TEAE) during the course of the study from Day 0 up to Month 6 is presented below.|From Inclusion Visit (Day 0) up to Month 6|"All 571 subjects in the Safety Set are included in the analysis of this outcome measure.
Safety Set comprises all patients included who have been treated with Vimpat® at least once."||participants|||Number
815318|NCT01098162|Secondary|Change in Number (Frequency) of Seizures With Secondary Generalization From Baseline to Month 6|"Baseline values for the seizure frequency (SF) during the 12 weeks time period prior to inclusion ('historical baseline'), and the post-baseline values of seizure frequency reported after 6 months were normalized to a 28 days interval.
Change in number of partial-onset seizures with secondary generalization was derived as follows:
Change in SF per 28 days = (SF at 6 months per 28 days) – (SF at Baseline per 28 days).
A negative value in change from Baseline means that the value has decreased from Baseline to Month 6.
Partial-onset seizures with secondary generalization can be classified into one of the following three groups:
Simple partial seizures evolving to generalized seizures
Complex partial seizures evolving to generalized seizures
Simple partial seizures evolving to Complex partial seizures evolving to generalized seizures."|From Baseline to Month 6|"Of the 520 subjects in the Full Analysis Set (FAS), 500 subjects are included in the analysis of this outcome measure.
FAS comprises all subjects who have been treated with Vimpat® at least once, who fulfill the inclusion criteria and for whom a valid baseline and post-baseline value of seizure frequency is available."||Seizures per 28 days||Standard Deviation|Mean
815319|NCT01098162|Secondary|Change in Number (Frequency) of Seizures With Secondary Generalization From Baseline to Month 3|"Baseline values for the seizure frequency (SF) during the 12 weeks time period prior to inclusion ('historical baseline'), and the post-baseline values of seizure frequency reported after 3 months were normalized to a 28 days interval.
Change in number of partial-onset seizures with secondary generalization was derived as follows:
Change in SF per 28 days = (SF at 3 months per 28 days) – (SF at Baseline per 28 days).
A negative value in change from Baseline means that the value has decreased from Baseline to Month 3.
Partial-onset seizures with secondary generalization can be classified into one of the following three groups:
Simple partial seizures evolving to generalized seizures
Complex partial seizures evolving to generalized seizures
Simple partial seizures evolving to Complex partial seizures evolving to generalized seizures."|From Baseline to Month 3|"Of the 520 subjects in the Full Analysis Set (FAS), 447 subjects are included in the analysis of this outcome measure.
FAS comprises all subjects who have been treated with Vimpat® at least once, who fulfill the inclusion criteria and for whom a valid baseline and post-baseline value of seizure frequency is available."||Seizures per 28 days||Standard Deviation|Mean
815320|NCT01098162|Secondary|Change in Number (Frequency) of Partial-onset Seizures Without Secondary Generalization From Baseline to Month 6|"Baseline values for the seizure frequency (SF) during the 12 weeks time period prior to inclusion ('historical baseline'), and the post-baseline values of seizure frequency reported after 6 months were normalized to a 28 days interval.
Change in number of partial-onset seizures was derived as follows:
Change in SF per 28 days = (SF at 6 months per 28 days) – (SF at Baseline per 28 days).
A negative value in change from Baseline means that the value has decreased from Baseline to Month 6.
Partial-onset seizures can be classified into one of the following three groups:
Simple partial seizures
Complex partial seizures
Partial seizures evolving to secondarily generalized seizures."|From Baseline to Month 6|"Of the 520 subjects in the Full Analysis Set (FAS), 500 subjects are included in the analysis of this outcome measure.
FAS comprises all subjects who have been treated with Vimpat® at least once, who fulfill the inclusion criteria and for whom a valid baseline and post-baseline value of seizure frequency is available."||Seizures per 28 days||Standard Deviation|Mean
815321|NCT01098162|Secondary|Change in Number (Frequency) of Partial-onset Seizures Without Secondary Generalization From Baseline to Month 3|"Baseline values for the seizure frequency (SF) during the 12 weeks time period prior to inclusion ('historical baseline'), and the post-baseline values of seizure frequency reported after 3 months were normalized to a 28 days interval.
Change in number of partial-onset seizures was derived as follows:
Change in SF per 28 days = (SF at 3 months per 28 days) – (SF at Baseline per 28 days).
A negative value in change from Baseline means that the value has decreased from Baseline to Month 3.
Partial-onset seizures can be classified into one of the following three groups:
Simple partial seizures
Complex partial seizures
Partial seizures evolving to secondarily generalized seizures."|From Baseline to Month 3|"Of the 520 subjects in the Full Analysis Set (FAS), 449 subjects are included in the analysis of this outcome measure.
FAS comprises all subjects who have been treated with Vimpat® at least once, who fulfill the inclusion criteria and for whom a valid baseline and post-baseline value of seizure frequency is available."||Seizures per 28 days||Standard Deviation|Mean
815548|NCT01100437|Secondary|Average Numeric Pain Rating Scale (NPRS) in Titration/Stabilization and Maintenance Phases|Average pain scores in the previous 24 hours using an 11 point NPRS ranging from no pain (0) to worst pain (10).|Baseline up to Day 63|ITT; N=number of participants with evaluable data; n=number of participants evaluated at the specific time point||units on a scale||Standard Deviation|Mean
815322|NCT01098162|Primary|Clinical Global Impression of Change (CGI-C) at Month 6|"For the assessment of the Clinical Global Impression of Change (CGI-C), the investigator provided his/her assessment of the subject's clinical status compared to Baseline. He/she was asked to check the category that best describes the subject's condition over the past 6 months compared to Baseline:
Very much improved
Much improved
Minimally improved
No change
Minimally worse
Much worse
Very much worse"|Month 6|"Of the 520 subjects in the Full Analysis Set (FAS), 515 subjects are included in the analysis of this outcome measure.
FAS comprises all subjects who have been treated with Vimpat® at least once, who fulfill the inclusion criteria and for whom a valid baseline and post-baseline value of seizure frequency is available."||participants|||Number
815323|NCT01098240|Other Pre-specified|The Sheehan Suicidality Tracking Scale (STS)|The Sheehan Suicidality Tracking Scale (STS) measures treatment-emergent suicidal ideation as well as behaviors. It can be administered by a clinician or filled in by a participant. Prior to analysis, the STS was mapped to the Columbia Classification Algorithm of Suicide Assessment(C-CASA) categories, which has 9-item including completed suicide, suicide attempt, preparatory acts, suicidal ideation, self-injurious behavior, self-injurious no intent, unknown fatal,unknown non-fatal or other not deliberate. Participants who were mapped to C-CASA items were reported.|Week 8 (double-blind baseline) and weeks 9 through 14|The full analysis set, which was defined as the set of all participants who consumed at least one dose of randomized study medication, was applied for the analysis. n = number of participants with evaluable data at each timeframe.||Participants|||Number
815324|NCT01098240|Secondary|Plasma CP-601,927 Concentration|Blood samples were collected for plasma CP-601,927 concentration analysis which was summarized by mean and standard deviation.|Week 11, 12 and 14|All randomized participants with at least one dose of study medication in DB (double blind) phase and one valid plasma concentration measurement collected during the DB phase was be included in the analyses of the PK endpoints. n = number of participants with evaluable data at each timeframe.||ng/mL||Standard Deviation|Mean
815325|NCT01098240|Secondary|Population Pharmacokinetics|Population pharmacokinetic analysis involved mixed effects modeling using nonlinear mixed effects modeling (NONMEM) software. The intent of this analysis was to establish a basic population pharmacokinetic model for CP-601,927 and to determine inter-individual and residual variability in population clearance, and volume of distribution of drug. Relationship of demographic variables (gender, age, body weight, height and ethnicity), concomitant medications and measures of altered hepatic and renal function were examined by fitting measured CP-601,927 concentrations|Weeks 11,12 and 14||||||
815326|NCT01098240|Secondary|Number of Participants With Response at Weeks 9 Through 14|Response was defined as greater than 50 percent reduction from double-blind baseline in MADRS total score.|Weeks 9 through 14|The full analysis set, which was defined as the set of all participants who consumed at least one dose of randomized study medication, was applied for the analysis. n = number of participants with evaluable data at each timeframe.||Participants|||Number
815327|NCT01098240|Secondary|Number of Participants With Remission at Weeks 9, 10, 12 and 14|Remission was defined as response plus an absolute MADRS total score of less than or equal to 10 plus a CGI-I score less than 2 (’much’ or ’very much’ improved).|Weeks 9, 10, 12 and 14|The full analysis set, which was defined as the set of all participants who consumed at least one dose of randomized study medication, was applied for the analysis. n = number of participants with evaluable data at each timeframe.||Participants|||Number
815328|NCT01098240|Secondary|Clinical Global Impression - Improvement (CGI-I) Total Score at Weeks 9, 10, 12 and 14|CGI-I was defined as a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Weeks 8 (double-blind baseline) 9, 10, 12 and 14|The full analysis set, which was defined as the set of all participants who consumed at least one dose of randomized study medication, was applied for the analysis. n = number of participants with evaluable data at each timeframe.||Units on a scale||Standard Deviation|Mean
815329|NCT01098240|Secondary|Change From Double-blind Baseline in Sheehan Disability Scale (SDS) Subscale Score at Weeks 11 and 14|SDS subscale is defined as a self-administered tool that measures functional impairment in 3-item including work/school, social life, and family life/home responsibilities. Items are rated on a scale of 0-10 visual analog scale, for a total numeric range of scores from 0 (not at all impaired) to 30 (extremely impaired).|Weeks 8 (double-blind baseline), 11 and 14|The full analysis set, which was defined as the set of all participants who consumed at least one dose of randomized study medication, was applied for the analysis. n = number of participants with evaluable data at each timeframe.||Units on a scale||Standard Deviation|Mean
815330|NCT01098240|Secondary|Change From Double-blind Baseline in Sheehan Disability Scale (SDS) Total Score at Weeks 11 and 14|SDS is defined as a self-administered tool that measures functional impairment including work/school, social life, and family life/home responsibilities. Items are rated on a scale of 0-10 visual analog scale (0=not at all impaired, 10=extremely impaired), for a total numeric range of scores from 0 (not at all impaired) to 30 (extremely impaired).|Weeks 8 (double-blind baseline), 11 and 14|The full analysis set, which was defined as the set of all participants who consumed at least one dose of randomized study medication, was applied for the analysis. n = number of participants with evaluable data at each timeframe.||Units on a scale||Standard Deviation|Mean
815331|NCT01098240|Secondary|Change From Double-blind Baseline in Sheehan Irritability Scale (SIS) Total Score at Weeks 11 and 14|The SIS is to rate suffering with regard to irritability symptoms. The degree to which irritability interferes with work, social and family function is also queried. The total SIS score is the sum of 7 items. Each item is rated on a scale of 0-10, for a total numeric range of scores from 0 (not at all) to 70 (extremely). The SIS also records the number of days impaired by irritability.|Weeks 8 (double-blind baseline), 11 and 14|The full analysis set, which was defined as the set of all participants who consumed at least one dose of randomized study medication, was applied for the analysis. n = number of participants with evaluable data at each timeframe.||Units on a scale||Standard Deviation|Mean
815376|NCT01098500|Primary|Number of Patients With ALT (Alanine Transaminase) >=3x (Times) Upper Limit of Normal (ULN)|Prevalence of patients with an ALT elevation >=3x ULN among patients who had liver function testing during the baseline period (30 days prior to initiation of TKI drug).|Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.|Members of the TKI cohort who had liver function testing within 30 days prior to the initiation of TKI drug.||participants|||Number
815332|NCT01098240|Secondary|Change From Double-blind Baseline in Clinical Global Impression - Severity (CGI-S) at Weeks 9, 10, 12, and 14|CGI-S was defined as 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill participants). Higher score = more affected.|Week 8 (double-blind baseline) and weeks 9, 10, 12, 14|The full analysis set, which was defined as the set of all participants who consumed at least one dose of randomized study medication, was applied for the analysis. n = number of participants with evaluable data at each timeframe.||Units on a scale||Standard Deviation|Mean
815333|NCT01098240|Secondary|Change From Double-blind Baseline in Bech Melancholia Subscale Score at Weeks 9 Through 14|The Bech Melancholia is sum of scores on 6 items (items 1, 2, 7, 8, 10 and 13) pertaining to melancholia within HAM-D. The items are rated on a scale of 0-4, higher scores reflecting greater severity. Total possible score is 0-24.|Weeks 8 (double-blind baseline) through 14|The full analysis set, which was defined as the set of all participants who consumed at least one dose of randomized study medication, was applied for the analysis. n = number of participants with evaluable data at each timeframe.||Units on a scale||Standard Deviation|Mean
815334|NCT01098240|Secondary|Change From Double-blind Baseline in Hamilton Depression Scale 25-item (HAM-D25) - Total Score at Weeks 9 Through 14|The HAM-D25 is the 25-item version of a scale used to assess the range of depressive symptoms including depressed mood, work and activities, sleep, suicidal thinking, psychomotor agitation/retardation, appetite, sexual interest, anxiety, somatic symptoms, and cognitive symptoms. The items on the HAM-D were rated on a scale of 0-2 or 0-4, for a total numeric range of scores from 0 (depressive symptoms absent) to 72 (numerically highest level of depressive symptoms).|Weeks 8 (double-blind baseline) through 14|The full analysis set, which was defined as the set of all participants who consumed at least one dose of randomized study medication, was applied for the analysis. n = number of participants with evaluable data at each timeframe.||Units on a scale||Standard Deviation|Mean
815335|NCT01098240|Secondary|Change From Double-blind Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score at Weeks 9 Through 13|MADRS measures the overall severity of depressive symptoms. The MADRS had a 10-item checklist. Items are rated on a scale of 0-6, for a total numeric range of scores from 0 (depressive symptoms absent) to 60 (numerically highest level of depressive symptoms).|Week 8 (double-blind baseline) and weeks 9 through 13|The full analysis set, which was defined as the set of all participants who consumed at least one dose of randomized study medication, was applied for the analysis. n = number of participants with evaluable data at each timeframe.||Units on a scale||Standard Deviation|Mean
815336|NCT01098240|Primary|Change From Double-blind Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score at Week 14|MADRS measures the overall severity of depressive symptoms. The MADRS had a 10-item checklist. Items are rated on a scale of 0-6, for a total numeric range of scores from 0 (depressive symptoms absent) to 60 (numerically highest level of depressive symptoms).|Week 8 (double-blind baseline ) and week 14 (week 6 of double-blind phase)|The full analysis set, which was defined as the set of all participants who consumed at least one dose of randomized study medication, was applied for the analysis. n = number of participants with evaluable data at each timeframe.||Units on a scale||Standard Deviation|Mean
815337|NCT01098253|Secondary|Nine Item Patient Health Questionnaire (PHQ-9)|Depressive symptoms were measured using the nine-item Patient Health Questionnaire (PHQ-9). PHQ-9 scored on a range from 0 to 27, where lower scores represent fewer depressive symptoms.|3 months|Analysis proceeded at the patient level and patients were analyzed according to the treatment to which they were randomized (intent-to-treat).||Percentage of participants with PHQ-9 <5|||Number
815338|NCT01098253|Primary|Hemoglobin A1C|HbA1c levels will be obtained in accordance with ADA guidelines (1) employing the in2it A1C Analyzer. The Analyzer offers accurate point of care HbA1c testing. Point of care testing using this device has acceptable precision and agreement in comparison with laboratory services|3 months|Analysis proceeded at the patient level and patients were analyzed according to the treatment to which they were randomized (intent-to-treat).||Percentage of participants with HbA1c <7|||Number
815339|NCT01098305|Secondary|Nicotine Withdrawal and Craving, Negative Affect, Positive Affect, and Side Effects.|Side Effects|Ongoing throughout the treatment period (Baseline to the end of treatment, 12 weeks)|||participants|||Number
815340|NCT01098305|Primary|7-day Point Prevalence Smokeless Tobacco Abstinence Biochemically Confirmed With Urine Cotinine at the End of 12 Weeks of Treatment.||At the end of treatment (12 weeks)|||participants|||Number
815341|NCT01098318|Secondary|Treatment Emergent Side Effects Scale Will be Used to Assess Treatment-related Side Effects as a Secondary Outcome Measure.||12 weeks||||||
815342|NCT01098318|Secondary|Change in Suicide Ideation as Determined by the Columbia Suicide Form Will be a Secondary Outcome Measure.||12 weeks||||||
815343|NCT01098318|Secondary|Change in Sexual Function Will be a Secondary Outcome Measure.||12 weeks||||||
815344|NCT01098318|Secondary|Reduction in Depressive Symptoms as Measured by the Beck Depression Inventory Will be a Secondary Outcome Measure.||12 weeks||||||
815345|NCT01098318|Secondary|The Clinical Global Impression (CGI) Severity and Change Ratings Will be Secondary Outcome Measures.||12 weeks||||||
815346|NCT01098318|Primary|Depressive Symptoms as Measured by the Hamilton Depression Rating Scale (17-items) at Week 8 and Week 12.|Hamilton Depression Rating Scale (HAM-D) is a validated, clinician-rated instrument for ascertaining the severity of MDD symptoms. The 28-item Hamilton Depression Rating Scale was used to determine the primary outcome of 17-item HAM-D score. The HAM-D will serves as the primary outcome measure. HAM-D17 score ranges from 0 to 68. Higher score indicates more depressed symptom.|12 weeks|||units on a scale||Standard Deviation|Mean
815373|NCT01098500|Primary|Incidence of Hy’s Law (ALT or AST >=3x ULN and ALP <2x ULN and BIL >=2x ULN)|Number of patients with Hy’s Law (ALT or AST >= 3x ULN and ALP <2x ULN and BIL >= 2x ULN) among patients with normal ALT, AST, ALP, and BIL measurements during the baseline period (30 days prior to initiation of TKI drug). Normal is defined as an ALT AST, ALP, and BIL <1 times ULN at baseline.|Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.|Members of the TKI cohort who had normal ALT, AST, ALP, and BIL (<1x ULN) during baseline (within 30 days prior to the initiation of TKI drug).||participants|||Number
815458|NCT01099579|Secondary|Mean CD4 Percent Changes From Baseline at Week 48 by Treatment/Weight||From Baseline to Week 48|Participants who received at least 1 dose of atazanavir (ATV) and who had CD4 percent at baseline and Week 48 while taking ATV powder||Percentage of lymphocytes||Standard Error|Mean
815347|NCT01098461|Secondary|Mean Half-maximal Effective Concentration (EC50) of Albiglutide for HbA1c and FPG|EC50 is defined as the concentration of albiglutide that give a half-maximal HbA1c and FPG response. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 1, 4, 5, 8, 12, and 13) and on the day of the clinic visit at Weeks 16, 20, and 24. At Weeks 0, 1, 4, 8, and 12, PK samples were collected immediately prior to dosing if a dose was scheduled for that week. At Weeks 16, 20, and 24, PK samples were collected at any time during the visit. The Week 5 post-dose PK sampling was performed any time between Weeks 4 and 6, within 2 to 5 days after administration of a dose; Week 13 post-dose PK sampling was performed any time between Weeks 12 and 14, within 2 to 5 days after administration of a dose of study medication. EC50 estimates used PK data as well as HbA1c and FPG efficacy data. EC50 was estimated from an inhibitory Emax (maximal possible effect of albiglutide) model.|Weeks 0, 1, 4, 5, 8, 12, 13, 16, 20, and 24|PK/PD Analysis Pop: all participants in the PK Analysis Pop with sufficient dosing history for inclusion in the PK/PD analysis. Modeled population PK data (analyzed using a non-linear mixed effect modeling approach) are presented. A one-compartment PK model with first-order absorption/elimination processes was selected to describe GSK716155 PK.||nanograms per milliliter||95% Confidence Interval|Mean
815348|NCT01098461|Secondary|Mean Absorption Rate of Albiglutide|Absorption rate is defined as the rate at which albiglutide enters the blood circulation. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 1, 4, 5, 8, 12, and 13) and on the day of the clinic visit at Weeks 16, 20, and 24. At Weeks 0, 1, 4, 8, and 12, PK samples were collected immediately prior to dosing if a dose was scheduled for that week. At Weeks 16, 20, and 24, PK samples were collected at any time during the visit. The Week 5 post-dose PK sampling was performed any time between Weeks 4 and 6, within 2 to 5 days after administration of a dose; Week 13 post-dose PK sampling was performed any time between Weeks 12 and 14, within 2 to 5 days after administration of a dose of study medication. Modeled population PK data are presented; data were analyzed using a non-linear mixed effect modeling approach. A one-compartment PK model with first-order absorption and elimination processes was selected to describe GSK716155 PK.|Weeks 0, 1, 4, 5, 8, 12, 13, 16, 20, and 24|PK Analysis Population (Pop)||hour^-1||95% Confidence Interval|Mean
815349|NCT01098461|Secondary|Mean Volume of Distribution of Albiglutide|Volume of distribution is defined as the apparent volume in which albiglutide is distributed. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 1, 4, 5, 8, 12, and 13) and on the day of the clinic visit at Weeks 16, 20, and 24. At Weeks 0, 1, 4, 8, and 12, PK samples were collected immediately prior to dosing if a dose was scheduled for that week. At Weeks 16, 20, and 24, PK samples were collected at any time during the visit. The Week 5 post-dose PK sampling was performed any time between Weeks 4 and 6, within 2 to 5 days after administration of a dose; Week 13 post-dose PK sampling was performed any time between Weeks 12 and 14, within 2 to 5 days after administration of a dose of study medication. Modeled population PK data are presented; data were analyzed using a non-linear mixed effect modeling approach. A one-compartment PK model with first-order absorption and elimination processes was selected to describe GSK716155 PK.|Weeks 0, 1, 4, 5, 8, 12, 13, 16, 20, and 24|PK Analysis Population||Liters||95% Confidence Interval|Mean
815350|NCT01098461|Secondary|Mean Clearance of Albiglutide|Clearance is defined as the volume of plasma cleared of albiglutide per unit time. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 1, 4, 5, 8, 12, and 13) and on the day of the clinic visit at Weeks 16, 20, and 24. At Weeks 0, 1, 4, 8, and 12, pharmacokinetic (PK) samples were collected immediately prior to dosing if a dose was scheduled for that week. At Weeks 16, 20, and 24, PK samples were collected at any time during the visit. The Week 5 post-dose PK sampling was performed any time between Weeks 4 and 6, within 2 to 5 days after administration of a dose; Week 13 post-dose PK sampling was performed any time between Weeks 12 and 14, within 2 to 5 days after administration of a dose of study medication. Modeled population PK data are presented; data were analyzed using a non-linear mixed effect modeling approach. A one-compartment PK model with first-order absorption and elimination processes was selected to describe GSK716155 PK.|Weeks 0, 1, 4, 5, 8, 12, 13, 16, 20, and 24|PK Analysis Population: all participants for whom a PK sample was obtained and analyzed||milliliters per hour||95% Confidence Interval|Mean
815351|NCT01098461|Secondary|Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5% and <7% at Weeks 4, 8, 12, and 16|The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5% and <7%) were assessed.|Week 4, Week 8, Week 12, and Week 16|ITT Population with LOCF. Only those participants with a value available at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were discontinued from active treatment before Week 16.||Participants|||Number
815352|NCT01098461|Secondary|Change From Baseline in Body Weight at Week 4, 8, 12, and 16|The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The LOCF method was used to impute missing post-Baseline weight values.|Baseline; Week 4, Week 8, Week 12, and Week 16|ITT Population with LOCF. Only those participants with a value available at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were discontinued from active treatment before Week 16.||Kilograms||Standard Deviation|Mean
815353|NCT01098461|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 4, 8, 12, and 16|The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. The LOCF method was used to impute missing post-Baseline FPG values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; Week 4, Week 8, Week 12, and Week 16|ITT Population with LOCF. Only those participants with a value available at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were discontinued from active treatment before Week 16.||Millimoles per liter (mmol/L)||Standard Deviation|Mean
815374|NCT01098500|Primary|Number of Hy’s Law Patients (ALT or AST >= 3x ULN and ALP <2x ULN and BIL >= 2x ULN)|Prevalence of patients with Hy’s Law (ALT or AST >=3x ULN and ALP <2x ULN and BIL >=2x ULN, where AST = aspartate transaminase, ALP = alkaline phosphatase, BIL= bilirubin) among patients who had liver function testing during the baseline period (30 days prior to initiation of TKI drug).|Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.|Members of the TKI cohort who had liver function testing within 30 days prior to the initiation of TKI drug).||participants|||Number
816937|NCT01116921|Secondary|Incidence of Severe IVH or PVL||During hospitalization|||Participants|||Count of Participants
815354|NCT01098461|Secondary|Change From Baseline in HbA1c at Weeks 4, 8, 12, and 16|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the value at Week 16 minus the value at Baseline. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Baseline; Week 4, Week 8, Week 12, and Week 16|ITT Population with LOCF. Only those participants with a value available at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were discontinued from active treatment before Week 16.||Percentage of HbA1c in the blood||Standard Deviation|Mean
815355|NCT01098461|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 16|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the value at Week 16 minus the value at Baseline. Based on Analysis of Covariance (ANCOVA): Change = treatment + Baseline HbA1c + prior therapy. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Baseline and Week 16|Intent-to-Treat (ITT) Population: all randomized participants with at least one post-Baseline assessment of the primary endpoint, HbA1c. Only those participants with a value available at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were discontinued from active treatment before Week 16.||Percentage of HbA1c in the blood||Standard Error|Least Squares Mean
815356|NCT01098487|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) Started On-therapy + 1 Day, >1 to 30 Days Post Therapy and >30 Days Post Therapy|On-therapy + 1 day is defined as AEs started between the first dose of eltrombopag and up to the day after the last dose of eltrombopag; >1 to 30 days post therapy is defined as AEs that started more than 1 day and up to 30 days after the last dose of eltrombopag; >30 days post therapy is defined as AEs started that started more than 30 days after the last dose of eltrombopag. An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect. Medical or scientific judgment should be exercised in other situations.|From Week 1 up to Week 104 and up to 6 months follow-up (4 weeks for most participants) (up to approximately 2.5 years)|ATS Population||Participants|||Number
815357|NCT01098487|Secondary|Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study|Hematology parameters were summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0: G0, none; G1, mild; G2, moderate; G3, severe; G4, life-threatening or disabling. Hematology parameters included: hemoglobin (increased), hemoglobin (anemia), lymphocyte count (increased), lymphocyte count (decreased), total absolute neutrophil count (ANC), platelet count and white blood cell (WBC) count. Baseline values were obtained at Day 1. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). The maximum post-Baseline toxicity grade includes any scheduled or unscheduled post-Baseline assessment during.|From Week 1 up to Week 104 and up to 6 months follow-up (4 weeks for most participants) (up to approximately 2.5 years)|ATS Population||Participants|||Number
815358|NCT01098487|Secondary|Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study|Clinical chemistry parameters were summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0: G0, none; G1, mild; G2, moderate; G3, severe; G4, life-threatening or disabling. Clinical chemistry parameters included: albumin, alkaline phosphatase (ALP), alanine amino transferase (ALT), aspartate amino transferase (AST), total bilirubin, calcium (hypercalcemia), calcium (hypocalcemia), potassium (hyperkalemia), potassium (hypokalemia), sodium (hypernatremia), sodium (hyponatremia), inorganic phosphorus and creatinine. Baseline values were obtained at Day 1. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). The maximum post-Baseline toxicity grade includes any scheduled or unscheduled post-Baseline assessment during.|From Week 1 up to Week 104 and up to 6 months follow-up (4 weeks for most participants) (up to approximately 2.5 years)|ATS Population||Participants|||Number
815359|NCT01098487|Primary|Number of Participants With a Positive or Negative Collagen Level at 2 Year|The change from Baseline to on-treatment assessments of collagen level was analyzed. On-treatment is defined as during the treatment period (including dose interruptions) and up to 14 days after the end of the treatment period.|2 years|ATS Population. Participants with bone marrow biopsy data available in the relevant time period were included.||Participants|||Number
815360|NCT01098487|Primary|Number of Participants With a Positive or Negative Collagen Level at 1 Year|The change from Baseline to on-treatment assessments of collagen level was analyzed. On-treatment is defined as during the treatment period (including dose interruptions) and up to 14 days after the end of the treatment period.|1 year|ATS Population. Participants with bone marrow biopsy data available in the relevant time period were included.||Participants|||Number
815375|NCT01098500|Primary|Incidence of ALT >=3x ULN|Number of patients with ALT >=3 times ULN among patients with a normal ALT measurement during the baseline period (30 days prior to initiation of TKI drug). Normal is defined as an ALT <1 times ULN at baseline.|Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.|Members of the TKI cohort who had normal ALT (<1x ULN) during baseline (within 30 days prior to the initiation of TKI drug)||participants|||Number
815459|NCT01099579|Secondary|CD4 Cell Count Changes From Baseline at Week 48 by Prior Antiretroviral (ARV) Treatment Status||From Baseline to Week 48|Participants who received at least 1 dose of atazanavir (ATV) and who had CD4 at baseline and Week 48 while taking ATV powder||Cells/mm^3||Standard Error|Mean
816938|NCT01116921|Secondary|Incidence of Pulmonary Airleaks||First 7 days of life|||Participants|||Count of Participants
815361|NCT01098487|Primary|Number of Participants With Indicated Change From Baseline in the EC Grading Scale at 2 Years|The change from baseline to on-treatment assessments of European Consensus (EC) scale was analyzed. On-treatment is defined as during the treatment period (including dose interruptions) and up to 14 days after the end of the treatment period. MF-0 is scattered linear reticulin with no intersections (cross-overs) corresponding to normal BM; MF-1 is loose network of reticulin with many intersections, especially in perivascular areas; MF-2 is diffuse and dense increase in reticulin with extensive intersections, occasionally with only focal bundles of collagen and/or focal osteosclerosis; MF-3 is diffuse and dense increase in reticulin with extensive intersections with coarse bundles of collagen, often associated with significant osteosclerosis. Baseline is defined as the most recent centrally-reviewed BM biopsy prior to first dose of eltrombopag in the study.|Baseline and 2 years|ATS Population. Participants with bone marrow biopsy data available in the relevant time period were included.||Participants|||Number
815362|NCT01098487|Primary|Number of Participants With Indicated Grade Change From Baseline in the EC Grading Scale at 1 Year|The change from baseline to on-treatment assessments of European Consensus (EC) scale was analyzed. On-treatment is defined as during the treatment period (including dose interruptions) and up to 14 days after the end of the treatment period. MF-0 is scattered linear reticulin with no intersections (cross-overs) corresponding to normal BM; MF-1 is loose network of reticulin with many intersections, especially in perivascular areas; MF-2 is diffuse and dense increase in reticulin with extensive intersections, occasionally with only focal bundles of collagen and/or focal osteosclerosis; MF-3 is diffuse and dense increase in reticulin with extensive intersections with coarse bundles of collagen, often associated with significant osteosclerosis. Baseline is defined as the most recent centrally-reviewed BM biopsy prior to first dose of eltrombopag in the study.|Baseline and 1 year|ATS Population. Participants with bone marrow biopsy data available in the relevant time period were included.||Participants|||Number
815363|NCT01098487|Primary|Number of Participants With a Positive or Negative Collagen Level at Baseline|The number of participants with a positive or negative collagen level was analyzed. Baseline is defined as the most recent centrally-reviewed BM biopsy prior to first dose of eltrombopag in the study.|Baseline|ATS Population. Participants with bone marrow biopsy data available in the relevant time period were included.||Participants|||Number
815364|NCT01098487|Primary|Number of Participants With Bone Marrow (BM) Fibers of MF Grade 0, 1, 2 and 3 on the European Consensus (EC) Scale at Baseline|The evaluation of fibrosis was performed using BM biopsies in which the amount of fibrosis was assessed by the EC Grading Scale. This method distinguishes four degrees of fibrosis (myelofibrosis [MF]-0 to MF-3). MF Grade (G) 0 is scattered linear reticulin with no intersections (cross-overs) corresponding to normal BM; MF Grade 1 is loose network of reticulin with many intersections, especially in perivascular areas; MF Grade 2 is diffuse and dense increase in reticulin with extensive intersections, occasionally with only focal bundles of collagen and/or focal osteosclerosis; MF Grade 3 is diffuse and dense increase in reticulin with extensive intersections with coarse bundles of collagen, often associated with significant osteosclerosis. Baseline is defined as the most recent centrally-reviewed BM biopsy prior to first dose of eltrombopag in the study.|Baseline|All Treated Subjects (ATS) Population: all participants who received at least one dose of study medication excluding the 5 participants from Center 082877. Participants with bone marrow biopsy data available in the relevant time period were included.||Participants|||Number
815365|NCT01098500|Secondary|Median Time to the Maximum BIL Elevation During Follow-up|Median time (in months) between index date and date of maximum BIL elevation|Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.|Members of the TKI cohort who had at least one incident BIL elevation during follow-up.||months||Full Range|Median
815366|NCT01098500|Secondary|Maximum BIL Elevation Reached During Follow-up|Number of patients whose maximum BIL elevations fell within the indicated ULN range among patients with at least one incident BIL elevation during follow-up|Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.|Members of the TKI cohort who had at least one incident BIL elevation during follow-up.||participants|||Number
815367|NCT01098500|Secondary|Median Time to the Maximum ALP Elevation During Follow-up|Median time (in months) between index date and date of maximum ALP elevation|Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.|Members of the TKI cohort who had at least one incident ALP elevation during follow-up.||months||Full Range|Median
815368|NCT01098500|Secondary|Maximum ALP Elevation Reached During Follow-up|Number of patients whose maximum ALP elevation fell within the indicated ULN range among patients with at least one incident ALP elevation during follow-up|Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.|Members of the TKI cohort who had at least one incident ALP elevation during follow-up.||participants|||Number
815369|NCT01098500|Secondary|Median Time to the Maximum AST Elevation During Follow-up|Median time (in months) between index date and date of maximum AST elevation|Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.|Members of the TKI cohort who had at least one incident AST elevation during follow-up.||months||Full Range|Median
815370|NCT01098500|Secondary|Maximum AST Elevation Reached During Follow-up|Number of patients whose maximum AST elevation fell within the indicated ULN range among patients with at least one incident AST elevation during follow-up|Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.|Members of the TKI cohort who had at least one incident AST elevation during follow-up.||participants|||Number
815371|NCT01098500|Secondary|Median Time to the Maximum ALT Elevation During Follow-up|Median time (in months) between index date and the date of maximum ALT elevation.|Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.|Members of the TKI cohort who had at least one incident ALT elevation during follow-up.||months||Full Range|Median
815372|NCT01098500|Secondary|Maximum ALT Elevation Reached During Follow-up|Number of patients whose maximum ALT elevation fell within the indicated ULN range among patients with at least one incident ALT elevation during follow-up|Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.|Members of the TKI cohort who had at least one incident ALT elevation during follow-up.||participants|||Number
815475|NCT01099761|Secondary|Change in Pulmonary Function Tests (FVC)|Forced Vital Capacity (FVC); 1 of 3 separate tests employed to assess pulmonary function in this study|Baseline to End-of-Study Visit, approximately 24 weeks later.|||Liters||Standard Deviation|Mean
815377|NCT01098539|Secondary|Plasma Concentrations (Conc.) of Albiglutide at Week 8 and Week 16|Sparse population pharmacokinetic (PK) data were collected for population PK and PK/pharmacodynamic (PD) analyses. Participants (par.) who received albiglutide were initiated on a 30 mg weekly dosing regimen. Beginning at Week 4, uptitration of albiglutide was allowed based on glycemic parameters. As such, albiglutide plasma conc. achieved at each sampling time represent a mixed population of par. who received either 30 mg or 50 mg weekly for various durations. The PK and PK/PD of albiglutide were characterized using a population modeling approach. Mean albiglutide plasma conc. observed at Weeks 8 and 16 are presented. Par. came to the clinic at Weeks 8 and 16 without taking albiglutide/matching placebo. The pre-dose PK sample was taken immediately prior to dosing. The Week 8 post-dose sample was taken between Weeks 8 and 10, >=2 days after a dose of medication. The Week 16 post-dose PK sample was taken any time between Weeks 16 and 20, >=2 days after the previous dose of albiglutide.|Week 8 Pre-dose (immediately prior to dose), Week 8 Post-dose (at least 2 days after a dose of medication), Week 16 Pre-dose (immediately prior to dose), and Week 16 Post-dose (at least 2 days after previous dose of albiglutide)|ITT population. Only participants with data available at the indicated time points were analyzed.||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
815378|NCT01098539|Secondary|Change From Baseline in Body Weight Through Week 52: OC|Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The Baseline weight value is defined as the last non-missing value prior to treatment. This analysis used observed weight values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|Baseline; Week 1, Week 2 , Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, Week 26, Week 36, Week 48, and Week 52|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Kilograms||Standard Deviation|Mean
815379|NCT01098539|Secondary|Change From Baseline in Body Weight Through Week 26: LOCF|Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The Baseline weight value is defined as the last non-missing value prior to treatment. This analysis used the LOCF method for missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue werre treated as missing and were replaced with pre-rescue values.|Baseline; Week 1, Week 2 , Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 26|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Kilograms||Standard Deviation|Mean
815380|NCT01098539|Secondary|Change From Baseline in Body Weight at Week 26: LOCF|Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The Baseline weight value is defined as the last non-missing value prior to treatment. This analysis used the LOCF method for missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue werre treated as missing and were replaced with pre-rescue values. Based on ANCOVA: Change = treatment + Baseline weight + renal impairment + prior myocardial infarction history + age category + region.|Baseline; Week 26|ITT Population. Only those participants available at the specified time points were analyzed.||Kilograms||Standard Error|Least Squares Mean
815381|NCT01098539|Secondary|Time to Hyperglycemic Rescue Through Week 52|Hyperglycemic rescue was defined as meeting one of the following criteria, confirmed by a second sample drawn within 7 days and analyzed by the central laboratory: for the Week 2 to Week 4 visit, a single FPG value >=280 milligrams per deciliter (mg/dL); for the >Week 4 and <Week 12 visits, a single FPG value >=250 mg/dL and previous titration for >=4 weeks; for the >=Week 12 and <Week 26 visits, HbA1c >=8.5% and a <=0.5% reduction from Baseline and previous titration for >=4 weeks; for the >=Week 26 and <Week 48 visits, HbA1c >=8.5% and previous titration for >=4 weeks; for the >=Week 48 and <Week 52 visits, HbA1c >=8.0% and previous titration for >=4 weeks. Time to hyperglycemia rescue is the time between the date of first dose and the date of hyperglycemia rescue plus 1 day, or the time between the date of first dose and the date of last visit during active treatment period plus 1 day for participants not requiring rescue. This time is divided by 7 to express the result in weeks.|Week 2 to Week 52|ITT Population||Weeks||95% Confidence Interval|Median
815382|NCT01098539|Secondary|Number of Participants With the Indicated Time to Hyperglycemic Rescue Through Week 52|Hyperglycemic rescue was defined as meeting one of the following criteria, confirmed by a second sample drawn within 7 days and analyzed by the central laboratory: for the Week 2 to Week 4 visit, a single FPG value >=280 milligrams per deciliter (mg/dL); for the >Week 4 and <Week 12 visits, a single FPG value >=250 mg/dL and previous titration for >=4 weeks; for the >=Week 12 and <Week 26 visits, HbA1c >=8.5% and a <=0.5% reduction from Baseline and previous titration for >=4 weeks; for the >=Week 26 and <Week 48 visits, HbA1c >=8.5% and previous titration for >=4 weeks; for the >=Week 48 and <Week 52 visits, HbA1c >=8.0% and previous titration for >=4 weeks. Time to hyperglycemia rescue is the time between the date of first dose and the date of hyperglycemia rescue plus 1 day, or the time between the date of first dose and the date of last visit during active treatment period plus 1 day for participants not requiring rescue.|Week 2 to Week 52|ITT Population||Participants|||Number
815383|NCT01098539|Secondary|Number of Participants Who Achieved a Clinically Meaningful Improvement in the HbA1c Response Level of >=1.0%, >=1.5%, and >=2.0% at Week 52: OC|The number of participants who a clinically meaningful improvement from Baseline in the HbA1c response level of >=1.0%, >=1.5%, and >=2.0% at Week 52 assessed. The OC method (no imputation of missing data) was used. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Week 52|ITT Population. Only those participants available at the indicated time point were assessed.||Participants|||Number
815384|NCT01098539|Secondary|Number of Participants Who Achieved a Clinically Meaningful HbA1c Response Level of <6.5% and <7.0% at Week 52: OC|The number of participants who acheieved the HbA1c treatment goal (i.e., number of participants who achieved HbA1c <7% and <6.5% at Week 26) was assessed. The OC method (no imputation of missing data) was used. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Week 52|ITT Population. Only those participants available at the indicated time point were assessed.||Participants|||Number
815476|NCT01099761|Secondary|Change From Baseline in Time to Travel 10 Meters (Standardized 10-Meter-Walk/Run Test).||Baseline to End-of-Study Visit, approximately 24 weeks later.|||Change (sec) in 10MWT from baseline||Standard Deviation|Mean
815385|NCT01098539|Secondary|Number of Participants Who Achieved a Clinically Meaningful Improvement in the HbA1c Response Level of >=1.0%, >=1.5%, and >=2.0% at Week 26: LOCF|The number of participants who a clinically meaningful improvement from Baseline in the HbA1c response level of >=1.0%, >=1.5%, and >=2.0% at Week 26 were assessed. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Week 26|ITT Population. Only those participants available at the indicated time point were assessed.||Participants|||Number
815386|NCT01098539|Secondary|Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5% and <7.0% at Week 26: LOCF|The number of participants who acheieved the HbA1c treatment goal (i.e., the number of participants who achieved HbA1c <7% and <6.5% at Week 26) was assessed. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Week 26|ITT Population. Only those participants available at the indicated time point were assessed.||Participants|||Number
815387|NCT01098539|Secondary|Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 3, 4, 8, 12, 16, 20, 26, 36, 48, and Week 52: OC|The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is defined as the last non-missing value prior to treatment. Change from Baseline in FBG was calculated as the post-Baseline value minus the Baseline value. The OC method (no imputation of missing data) was used. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were analyzed in a particular treatment week if they had received at least one dose in that treatment week.|Baseline; Weeks 1, 2, 3, 4, 8, 12, 16, 20, 26, 36, 48, Week 52|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Millimoles per liter (mmol/L)||Standard Deviation|Mean
815388|NCT01098539|Secondary|Mean Change From Baseline in FPG at Weeks 4, 8, 12, 16, 20, and 26: LOCF|The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline in FBG was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were analyzed in a particular treatment week if they had received at least one dose in that treatment week.|Baseline; Weeks 4, 8, 12, 16, 20, and 26|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Millimoles per liter (mmol/L)||Standard Deviation|Mean
815389|NCT01098539|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26|The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is define as the last non-missing value before the start of treatment. Change from Baseline in FBG was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were analyzed in a particular treatment week if they had received at least one dose in that treatment week. Based on ANCOVA: Change = treatment + Baseline FPG + renal impairment + prior myocardial infarction history + age category + region.|Baseline; Week 26|ITT Population. Only those participants available at the specified time points were analyzed.||Millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
815390|NCT01098539|Secondary|Mean Change From Baseline in HbA1c at Weeks 4, 8, 12, 16, 20, 26, 36, 48, and Week 52: Observed Cases|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline in HbA1c was calculated as the post-Baseline value minus the Baseline value. The Observed Cases (OC) method (no imputation of missing data) was used. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were analyzed in a particular treatment week if they had received at least one dose in that treatment week.|Baseline; Weeks 4, 8, 12, 16, 20, 26, 36, 48, and 52|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Percentage of HbA1c in the blood||Standard Deviation|Mean
815391|NCT01098539|Secondary|Mean Change From Baseline in HbA1c at Weeks 4, 8, 12, 16, and 20: LOCF|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline in HbA1c was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were analyzed in a particular treatment week if they had received at least one dose in that treatment week.|Baseline; Weeks 4, 8, 12, 16, and 20|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Percentage of HbA1c in the blood||Standard Deviation|Mean
815477|NCT01099761|Secondary|Change in Distance Traveled in 6 Minutes (Standardized 6-Minute-Walk Test).|Change in distance traveled in 6 minutes (standardized 6-Minute-Walk Test); stratified by baseline age (<10 years vs. >=10 years)|Baseline to End-of-Study Visit, approximately 24 weeks later.|||change (m) in 6MWT from baseline||Standard Deviation|Mean
815392|NCT01098539|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline in HbA1c was calculated as the value at Week 26 minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with treatment group, region, history of prior myocardial infarction (yes versus no), and age category (<65 years versus >=65 years) as factors and Baseline HbA1c as a continuous covariate. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Baseline; Week 26|Intent-to-Treat (ITT) Population: all participants who received at least one dose of study medication and who had at least one post-Baseline assessment of the primary endpoint, HbA1c. Only those participants available at the indicated time point were assessed.||Percentage of HbA1c in the blood||Standard Error|Least Squares Mean
815393|NCT01098578|Other Pre-specified|Total Institutional Cost Savings|Difference between the total institutional cost of successfully treating 20 study patients with Floseal compared to the total institutional cost of treating the same number of patient with endoscopic surgery|End of study. Cost calculated after 20 patients were treated with Floseal|||US Dollars|||Number
815394|NCT01098578|Secondary|Cost Savings of Floseal Treatment in Comparison to Posterior Packing, Surgical, and Embolisation Treatments for Posterior Epistaxis.|The institutional cost for the treatment of posterior epistaxis patients with posterior packing, endoscopic surgery, and endovascular embolization, at TOH were calculated and compared with the institutional cost of a patient visit for posterior epistaxis successfully treated with the study protocol using Floseal. All costs were calculated in Canadian dollars (CAD), they were converted to US dollars (USD) using the current monetary exchange rate (total CAD x 1.03= total USD). For all of the patients treated in this study, the total institution cost was $24487.53 (USD). The minimal institutional cost of successfully treating all of the study patients with endoscopic surgery, would have been $53933.89 (USD) or 2.2 times the actual expense. (Total cost 20 participants Floseal/expected total cost 20 endoscopic surgery*100)This represents savings of $29446.39 (USD) or 45.40%|30 days|||percentage of expected cost|||Number
815395|NCT01098578|Primary|Effectiveness of Floseal for the Treatment of Posterior Epistaxis.|Successful treatment using the gelatin-thrombin matrix protocol (Floseal) was any case of posterior epistaxis that stopped following the immediate application of either one or two syringes of Floseal® and the epistaxis did not resume within fourteen days of the treatment date.|Immediate effect with 1 hour observation and follow-up at 5 and 30 days following treatment.|||participants|||Number
815396|NCT01098747|Secondary|Participant Global Evaluation of Study Medication|Participant global evaluation of study medication was performed at the 8-hour time point or immediately before taking the rescue medication. It was scored on a 6-point categorical scale where 0 = Very poor, 1 = Poor, 2 = Fair, 3 = Good, 4 = Very Good, and 5 = Excellent.|8 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||Units on a scale||Standard Deviation|Mean
815397|NCT01098747|Secondary|Cumulative Percentage of Participants With Complete Relief|Complete relief was defined as a PRR of 4. PRR was assessed on a 5-point categorical pain relief rating scale where 0=No relief to 4=Complete relief.|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||Percentage of participants|||Number
815398|NCT01098747|Secondary|Cumulative Percentage of Participants With Treatment Failure|Percentage of participants who withdrew from the study due to lack of efficacy or received rescue medication.|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||Percentage of participants|||Number
815399|NCT01098747|Secondary|Time to Treatment Failure|Median time of dropping out of the participants from the study due to lack of efficacy or rescue medication, whichever came first.|0 to 8 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||Hours||95% Confidence Interval|Median
815400|NCT01098747|Secondary|Cumulative Percentage of Participants With Confirmed First Perceptible Relief|Percentage of participants with first perceptible relief was evaluated by stopping a stopwatch labeled 'first perceptible relief' at the moment the participant first began to experience any relief. Stopwatch was active up to 8 hours after dosing or until stopped by the participant, or rescue medication was administered. The first perceptible relief was considered confirmed if the participant also stopped the second stopwatch indicating meaningful relief.|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||Percentage of participants|||Number
815401|NCT01098747|Secondary|Cumulative Percentage of Participants With Meaningful Relief|Percentage of participants with meaningful relief evaluated by stopping the stopwatch labeled ‘meaningful relief' at the moment the participant first began to experience meaningful relief. Stopwatch was active up to 8 hours after dosing or until stopped by the participant, or rescue medication was administered.|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||Percentage of participants|||Number
815402|NCT01098747|Secondary|Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID)|SPRID: time-weighted sum of PRID over 2, 3, 6 and 8 hours. SPRID score range:-2 (worst) to 14(best) for SPRID 0-2, -3(worst) to 21(best) for SPRID 0-3, -6(worst) to 42(best) for SPRID 0-6, -8(worst) to 56(best) for SPRID 0-8. PRID:sum of PID and PRR at each time point. Total score range for PRID: -1=worst to 7=best. PID:baseline pain severity score minus pain severity score at given time(score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). Total score range for PID: -1(worst) to 3(best), PRR: scored on 5-point pain relief rating scale(0=No relief to 4=Complete relief).|0-2, 0-3, 0-6, 0-8 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||Units on a scale||Standard Deviation|Mean
815496|NCT01100073|Primary|Change From Baseline in Spiralometry Measurement at the End of Maintenance (Left Hand)|Change (reduction) in tremor amplitude from baseline to end of study for the left hand|Week 0 to weeks 9-16 (Visit 3)|Full analysis set (FAS) - Patients for whom baseline and end of study spiralometry measurement (left hand) available||millimeters of tremor amplitude||Standard Deviation|Mean
815403|NCT01098747|Secondary|Time-weighted Sum of Pain Relief Rating (TOTPAR)|TOTPAR: time-weighted sum of PRR scores over 2, 3, 6 and 8 hours. TOTPAR score range was 0 (worst) to 8 (best) for TOTPAR 0-2, 0 (worst) to 12 (best) for TOTPAR 0-3, 0 (worst) to 24 (best) for TOTPAR 0-6, 0 (worst) to 32 (best) for TOTPAR 0-8. PRR was evaluated at different time points during the study up to 8 hours, and immediately after taking rescue medication (if necessary). PRR was assessed on a 5-point categorical pain relief rating scale wherein 0=No relief to 4=Complete relief.|0-2, 0-3, 0-6, 0-8 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||Units on a scale||Standard Deviation|Mean
815404|NCT01098747|Secondary|Time-weighted Sum of Pain Intensity Difference (SPID)|SPID: time-weighted sum of PID over 2, 3, 6 and 8 hours. SPID scores range was -2 (worst) to 6 (best) for SPID 0-2, -3 (worst) to 9 (best) for SPID 0-3, -6 (worst) to 18 (best) for SPID 0-6, -8 (worst) to 24 (best) for SPID 0-8. PID: baseline pain severity score minus pain severity score at a given time point (pain severity score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). Total score range for PID: -1(worst) to 3 (best).|0-2, 0-3, 0-6, 0-8 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||Units on a scale||Standard Deviation|Mean
815405|NCT01098747|Secondary|Sum of Pain Relief Rating and Pain Intensity Difference (PRID)|PRID was sum of PID and PRR at each post-dosing time point. The overall possible score range, for PRID was -1 (worst) to 7 (best). PID was derived by subtracting the pain severity score at a given post-dosing time point (pain severity score range 0 [none] to 3 [severe]) from the baseline score (Baseline pain severity score range 2 [moderate] to 3 [severe]). Total possible score range for PID: -1 (worst) to 3 (best). PRR was assessed on 5-point categorical pain relief rating scale (0=No relief to 4=Complete relief).|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||Units on a scale||Standard Deviation|Mean
815406|NCT01098747|Secondary|Pain Intensity Difference (PID)|PID was derived by subtracting the pain severity score at a given post-dosing time point (pain severity score range 0 [none] to 3 [severe]) from the baseline score (Baseline pain severity score range 2 [moderate] to 3 [severe]). Total possible score range for PID: -1 (worst) to 3 (best).|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||Units on a scale||Standard Deviation|Mean
815407|NCT01098747|Secondary|Pain Relief Rating (PRR)|PRR was evaluated at different time points during the study up to 8 hours after taking the study medication, and immediately before rescue medication was taken (if necessary). PRR was assessed on a 5-point categorical pain relief rating scale where 0=No relief to 4=Complete relief.|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||Units on a scale||Standard Deviation|Mean
815408|NCT01098747|Secondary|Time to Confirmed First Perceptible Relief|Participants evaluated the time to first perceptible relief by stopping a stopwatch labeled 'first perceptible relief' at the moment they first began to experience any relief. Stopwatch was active up to 8 hours after dosing or until stopped by the participant, or rescue medication was administered. The first perceptible relief was considered confirmed if the participant also stopped the second stopwatch indicating meaningful relief.|0 to 8 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||Minutes||95% Confidence Interval|Median
815409|NCT01098747|Primary|Time to Onset of Meaningful Relief|Participants evaluated the time to meaningful relief by stopping a second stopwatch labeled ‘meaningful relief' at the moment they first began to experience meaningful relief. Stopwatch was active up to 8 hours after dosing or until stopped by the participant, or rescue medication was administered.|0 to 8 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||Minutes||95% Confidence Interval|Median
815410|NCT01098747|Primary|Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference From 0-8 Hours (SPRID 0-8)|SPRID: time-weighted sum of pain relief rating combined with pain intensity difference (PRID) over 8 hours. SPRID 0-8 score range: -8 (worst) to 56 (best). PRID: sum of Pain intensity differences (PID) and pain relief rating (PRR) at each time point. PRID score range: -1=worst to 7=best. PID: baseline pain severity score minus pain severity score at a given time point (pain severity score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). PID score range: -1(worst) to 3 (best). PRR: assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief).|0 to 8 hours|Intent-to-treat (ITT) population included all randomized participants who received study medication and provided a baseline assessment.||Units on a scale||Standard Deviation|Mean
815411|NCT01098812|Secondary|Uncorrected Distance Visual Acuity (UCDVA)|Postoperative uncorrected distance visual acuity as measured by LogMAR acuity. For comparison: LogMAR value of 0.0 = Snellen 20/20; LogMar 0.10 = Snellen 20/25; LogMAR 0.20 = Snellen 20/32; LogMAR 0.30 = Snellen 20/40. Uncorrected distance visual acuity as measured by LogMAR acuity was assessed in the first eye (per participant) for contribution to the mean.|6 months after second eye implant|Available subjects at the final visit with measured uncorrected distance visual acuity.||LogMAR acuity values||Standard Deviation|Mean
815412|NCT01098812|Primary|Mean Percent Reduction in Cylinder|Reduction in cylinder postoperatively vs. preoperatively (baseline) as measured by keratometry and manifest refraction. Mean percent reduction in cylinder = (postoperative refractive cylinder minus preoperative keratometric cylinder)/(target refractive cylinder minus preoperative keratometric cylinder). Reduction in cylinder was assessed in the first eye (per participant) for contribution to the mean.|6 months after second eye implant compared to baseline|Subjects at the final visit with preoperative keratometric cylinder, intended/target cylinder and postoperative refractive cylinder.||percentage of reduction in cylinder||Standard Deviation|Mean
815413|NCT01098851|Primary|Number of Participants Requiring Airway Support|Drugs during surgery may cause the throat to relax and block breathing. To treat this, the caregiver administers airway support. Airway support is moving the jaw forward, inserting a plastic tube (nasal-oral airway) or applying a mask with positive pressure.|3 hours|||Participants|||Number
815414|NCT01098851|Primary|Number of Participants With Saturation Pattern Detection (SPD) Indicative of Repetitive Reductions in Air Flow|Saturation Pattern Detection (SPD) is the pattern of oxygen saturation values plotted against time that occurs when patients have cyclical reduced air movement during breathing. Their blood oxygen level decreases and increases as they slow and increase their breathing.|3 hours|||Participants|||Number
815415|NCT01099111|Primary|Colonic-Mucosa Associated Microbial Species Per Compiled Participants in 5 Different Arms|"The entire mucosal microbial community were profiled using high-throughput DNA sequencing and microarray technology. The microarray approach is based on 16S rRNA gene targeted oligonucleotide allowing the rapid detection of thousands of DNA sequences simultaneously and thus constitutes an ideal tool to generate a comprehensive and holistic view of the gut microbial community in all participants of all study arms.
Then they will be analysed between different colonic segments in each participant, pooled results of participants in each of the 5 arms will be compared to the measurable outcomes of other arms in general."|1 - 2 weeks|Each participant colonic mucosal microbiota populations pattern were analysed, and then compared to control to look for specific enrichments. If the DNA extract was not enough for sequencing, then the participant sample was excluded, however analysis calculation was based on all enrolled participants. The number analyzed here represent all enrolled||microbial species population||95% Confidence Interval|Number
815416|NCT01099202|Primary|Number of PRBC Transfusions During Initial 5 Months of Treatment|Total number of all packed red blood cells (PRBCs) transfusions (events) given to a participant throughout the 6 courses of chemotherapy treatment, collected and reported by participant from fifth week beginning baseline to 5 months.|5 weeks to 5 Months|Transfusion data was available in 79 of the 81 (98%) evaluable patients who completed the treatment/observation period.||transfusions||Standard Deviation|Mean
815417|NCT01099202|Primary|Mean Number of RBC Units Transfused During Initial 5 Months of Treatment|Total number of packed red blood cell (PRBCs) units transfused to participant beginning at fifth week, up until 5-months compared between the evaluable study group subsets.|5 weeks to 5 Months|Transfusion data was available in 79 of the 81 (98%) evaluable patients who completed the treatment/observation period.||PRBC Units||Standard Deviation|Mean
815418|NCT01099215|Secondary|The Fontaine Class of Peripheral Artery Disease|CLASSIFICATION OF PERIPHERAL ATERIAL DISEASE ACCORDING TO FONTAINE Stage Clinical description I Asymptomatic IIA Mild claudication IIB Moderate –severe claudication III Ischemic rest pain IV Ulceration or gangrene|change from baseline to 48 weeks|Intention-to-Treat Population Analysis||participants|||Number
815419|NCT01099215|Secondary|The Fontaine Class of Peripheral Artery Disease|CLASSIFICATION OF PERIPHERAL ATERIAL DISEASE ACCORDING TO FONTAINE Stage Clinical description I Asymptomatic IIA Mild claudication IIB Moderate –severe claudication III Ischemic rest pain IV Ulceration or gangrene|change from baseline to 24 weeks|Intention-to-Treat Population Analysis||participants|||Number
815420|NCT01099215|Secondary|The Fontaine Class of Peripheral Artery Disease|CLASSIFICATION OF PERIPHERAL ATERIAL DISEASE ACCORDING TO FONTAINE Stage Clinical description I Asymptomatic IIA Mild claudication IIB Moderate –severe claudication III Ischemic rest pain IV Ulceration or gangrene|change from baseline to 4 weeks|Intention-to-Treat Population Analysis||participants|||Number
815421|NCT01099215|Secondary|Changes in Physical Exam|Changes in physical examination were compared to baseline: numbers of subjects presenting any new finding or worsening of abnormal findings compared to the screening examination are reported|within 4, 24 and 48 weeks from baseline|Safety Population Analysis||participants|||Number
815422|NCT01099215|Secondary|Resting Ankle-brachial Index|ABI was calculated by dividing the systolic blood pressure at the ankle by the systolic blood pressures in the arm. This test is used to predict the severity of PAD.|within 4, 24 and 48 weeks from study procedure|Intention-to-Treat Population Analysis||ratio||Standard Deviation|Mean
815423|NCT01099215|Secondary|Number of Patients Requiring Reintervention of Target Lesion / Target Vessel|Survival analysis - outcome reported as patients requiring reintervention of the target lesion / vessel|up to 48 Weeks from study procedure|Intention-to-Treat Population Analysis||participants|||Number
815424|NCT01099215|Secondary|Rate of Binary In-stent Restenosis|"Binary restenosis relied on duplex ultrasound data with a Yes/No assessment with 0–49% being No (peak systolic velocity [PSV] ratio ≤2.4) and Yes being 50–99% (PSV ratio >2.4), with the PSV ratio calculated as PSV from stenosis divided by the PSV from a normal segment of artery proximal to the stenosis.
Ultrasound data was obtained for each patient at each time point and had to be considered diagnostic and evaluable by the core lab; if it was not, then this analysis could not be done for that particular subject."|within 48 weeks from study procedure|Intention-to-Treat Population Analysis (Data was not available for all 21 subjects because it includes only ultrasound data obtained that was considered diagnostic and evaluable by the core lab)||participants|||Number
815425|NCT01099215|Secondary|Rate of Binary In-stent Restenosis|"Binary restenosis relied on duplex ultrasound data with a Yes/No assessment with 0–49% being No (peak systolic velocity [PSV] ratio ≤2.4) and Yes being 50–99% (PSV ratio >2.4), with the PSV ratio calculated as PSV from stenosis divided by the PSV from a normal segment of artery proximal to the stenosis.
Ultrasound data was obtained for each patient at each time point and had to be considered diagnostic and evaluable by the core lab; if it was not, then this analysis could not be done for that particular subject."|within 24 weeks from study procedure|Intention-to-Treat Population Analysis (Data was not available for all 21 subjects because it includes only ultrasound data obtained that was considered diagnostic and evaluable by the core lab)||participants|||Number
815426|NCT01099215|Secondary|Rate of Binary In-stent Restenosis|"Binary restenosis relied on duplex ultrasound data with a Yes/No assessment with 0–49% being No (peak systolic velocity [PSV] ratio ≤2.4) and Yes being 50–99% (PSV ratio >2.4), with the PSV ratio calculated as PSV from stenosis divided by the PSV from a normal segment of artery proximal to the stenosis.
Ultrasound data was obtained for each patient at each time point and had to be considered diagnostic and evaluable by the core lab; if it was not, then this analysis could not be done for that particular subject."|within 4 weeks from study procedure|Intention-to-Treat Population Analysis (Data was not available for all 21 subjects because it includes only ultrasound data obtained that was considered diagnostic and evaluable by the core lab)||participants|||Number
815427|NCT01099215|Secondary|Maintenance of Primary Patency of Superficial Femoral Artery (SFA)|Primary patency was defined as duplex ultrasound peak systolic velocity [PSV] ratio ≤2.4.Ultrasound data was obtained for each patient at each time point and had to be considered diagnostic and evaluable by the core lab; if it was not, then this analysis could not be done for that particular subject.|within 48 weeks from study procedure|Intention-to-Treat Population Analysis (Data was not available for all 21 subjects because it includes only ultrasound data obtained that was considered diagnostic and evaluable by the core lab)||participants|||Number
815559|NCT01092832|Secondary|Time to Death||Baseline up to 1 month follow-up|No participants died within the safety reporting period, therefore time to death was not applicable.|||||
815428|NCT01099215|Secondary|Maintenance of Primary Patency of Superficial Femoral Artery (SFA)|Primary patency was defined as duplex ultrasound peak systolic velocity [PSV] ratio ≤2.4.Ultrasound data was obtained for each patient at each time point and had to be considered diagnostic and evaluable by the core lab; if it was not, then this analysis could not be done for that particular subject.|within 24 weeks from study procedure|Intention-to-Treat Population Analysis (Data was not available for all 21 subjects because it includes only ultrasound data obtained that was considered diagnostic and evaluable by the core lab)||participants|||Number
815429|NCT01099215|Secondary|Maintenance of Primary Patency of Superficial Femoral Artery (SFA)|Primary patency was defined as duplex ultrasound peak systolic velocity [PSV] ratio ≤2.4.Ultrasound data was obtained for each patient at each time point and had to be considered diagnostic and evaluable by the core lab; if it was not, then this analysis could not be done for that particular subject.|within 4 weeks from study procedure|Intention-to-Treat Population Analysis (Data was not available for all 21 subjects because it includes only ultrasound data obtained that was considered diagnostic and evaluable by the core lab)||participants|||Number
815430|NCT01099215|Secondary|Incidence of Adverse Events, Laboratory Abnormalities||Up to 48 weeks from study procedure|Safety Population Analysis||participants|||Number
815431|NCT01099215|Secondary|Incidence of Serious Adverse Events||Up to 48 weeks from study procedure|Intention-to-Treat Population Analysis||participants|||Number
815432|NCT01099215|Secondary|Incidence of Major Adverse Events (MAEs)|"Major Adverse Events are:
Death
Major amputation
Procedural related serious adverse events
Investigational product related serious adverse events"|within 24 and 48 weeks from study procedure|Intention-to-Treat Population Analysis||participants|||Number
815433|NCT01099215|Primary|Incidence of Major Adverse Events (MAEs)|"Major Adverse Events are:
Death
Major amputation
Procedural related serious adverse events
Investigational product related serious adverse events"|within 4 weeks after study procedure|Intention-to-Treat Population Analysis||participants|||Number
815434|NCT01099267|Primary|Cause of Death for Participants Who Died|Summary of the cause of death for participants from MDS-003 who died as of the time of the extension study follow-up.|up to 7 years|Safety population of participants who died||participants|||Number
815435|NCT01099267|Primary|Kaplan Meier Estimate for Progression to Acute Myeloid Leukemia (AML)|Progression to AML was measured from the start of therapy in CC-5013-MDS-003 to the date AML was diagnosed. Results include data collected during the extension follow-up.|up to 7 years|Intent to treat population. One participant was diagnosed by central reviewer as having AML at entry to the MDS-003 study (baseline) so was excluded from this analysis.||months||95% Confidence Interval|Median
815436|NCT01099267|Primary|Participants Status Regarding Progression to Acute Myeloid Leukemia (AML) as of the Time of the Extension Study Follow-up|Count of participants who progressed to AML at the time of the extension study follow-up.|up to 7 years|Intent to treat population. One participant was diagnosed by central reviewer as having AML at entry to the MDS-003 study (baseline) so was excluded from this analysis.||participants|||Number
815437|NCT01099267|Primary|Kaplan Meier Estimate for Overall Survival|Overall survival was measured from the start of therapy in CC-5013-MDS-003 to the date of death from any cause. Results include data collected during the extension follow-up.|up to 7 years|Intent to treat population||months||95% Confidence Interval|Median
815438|NCT01099267|Primary|Participants Survival Status as of the Time of the Extension Study Follow-up|Count of participants who were alive or deceased at the time of the extension study follow-up.|up to 7 years|Intent to treat population||participants|||Number
815439|NCT01099358|Primary|Cetuximab Pharmacokinetics: Confirmatory Serum Concentration||Group D:Cycle 1, Day 1: Prior to Cisplatin Infusion.|All participants who received at least one dose of study drug who were enrolled in Group D and had evaluable PK data.||micrograms per milliliters (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
815440|NCT01099358|Primary|Cetuximab Pharmacokinetics: Measurement of the Time After Administration When the Maximum Plasma Concentration is Reached (Tmax)||Group B:Cycle 1,Day 15 and Cycle 2, Day 1 and Group C: Cycle 1, Day 22 and Cycle 2, Day 1: Baseline (Prior to Cetuximab Infusion),1, 2, 4, 8, 24, 72, 120, and 168 hours (After the Start of Cetuximab Infusion).|All participants who received at least one dose of study drug who were enrolled in Group B and C and had evaluable PK data. Study design by intent did not collect data from Group A or Group D.||Hours (h)||Full Range|Median
815441|NCT01099358|Primary|Total Cisplatin Pharmacokinetics: Measurement of the Time After Administration When the Maximum Plasma Concentration is Reached (Tmax)||Groups A and C: Cycle 1,Day 1 and Cycle 2 Day 1; Baseline (Prior to Cisplatin Infusion), 1, 1.50, 2, 3, 5, 8, 24, 72 hours (After the Start of Cisplatin Infusion).|All participants who received at least one dose of study drug who were enrolled in Group A or C and had evaluable PK data. Study design by intent did not collect data from Group B or Group D.||Hours (h)||Full Range|Median
815442|NCT01099358|Primary|Cetuximab Pharmacokinetics: Maximum Observed Plasma Concentration at Steady State (Cmax,ss)||Group B:Cycle 1,Day 15 and Cycle 2, Day 1 and Group C: Cycle 1, Day 22 and Cycle 2, Day 1: Baseline (Prior to Cetuximab Infusion),1, 2, 4, 8, 24, 72, 120, and 168 hours (After the Start of Cetuximab Infusion).|All participants who received at least one dose of study drug who were enrolled in Group B and C and had evaluable PK data. Study design by intent did not collect data from Group A or Group D.||micrograms per milliliters (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
815443|NCT01099358|Primary|Total Cisplatin Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax)||Groups A and C: Cycle 1,Day 1 and Cycle 2 Day 1; Baseline (Prior to Cisplatin Infusion), 1, 1.50, 2, 3, 5, 8, 24, 72 hours (After the Start of Cisplatin Infusion).|All participants who received at least one dose of study drug who were enrolled in Group A or C and had evaluable PK data. Study design by intent did not collect data from Group B or Group D.||micrograms/milliliters(μg/mL)||Geometric Coefficient of Variation|Geometric Mean
815444|NCT01099358|Primary|Cetuximab Pharmacokinetics: Area Under the Concentration Versus Time Curve During One Dosing Interval at Steady State (AUC τ,ss)||Group B:Cycle 1,Day 15 and Cycle 2, Day 1 and Group C: Cycle 1, Day 22 and Cycle 2, Day 1: Baseline (Prior to Cetuximab Infusion),1, 2, 4, 8, 24, 72, 120, and 168 hours (After the Start of Cetuximab Infusion).|All participants who received at least one dose of study drug who were enrolled in Group B or C and had evaluable PK data. Study design by intent did not collect data from Group A or Group D.||micrograms*hour/milliliters (μg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
815560|NCT01092832|Secondary|All-Cause Mortality - Number of Participant Deaths||Day 28 and 1 Month Follow-up|Safety population||participants|||Number
815445|NCT01099358|Primary|Total Cisplatin Pharmacokinetics (PK): Area Under the Concentration (AUC) Versus Time Curve From Time Zero to Infinity (AUC[0-∞])||Groups A and C: Cycle 1,Day 1 and Cycle 2 Day 1; Baseline (Prior to Cisplatin Infusion), 1, 1.50, 2, 3, 5, 8, 24, 72 hours (After the Start of Cisplatin Infusion).|All participants who received at least one dose of study drug who were enrolled in Group A or C and had evaluable PK data. Study design by intent did not collect data from Group B or Group D.||micrograms*hour/milliliters (μg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
815446|NCT01099397|Primary|Number of Participants Diagnosed With Prediabetes or Normal Glucose, by 2 Measurements (Fasting Glucose Measurement and Glucose Measurement After a 2-hour Oral Glucose Tolerance Test [OGTT]), at Three Timepoints During Antihypertensive Treatment|A single cohort of patients was followed through participation in the parent study, PEAR, and had both fasting and 2-hour OGTT labs evaluated at three time points. At each of these time points the two methods for evaluating prediabetes were compared. Consistent with the definition for prediabetes recommended by the American Diabetes Association, a fasting glucose above 99mg/dL or 2-hour oral glucose tolerance test glucose above 139mg/dL was considered prediabetic for this study.|Baseline, 9 weeks, and 18 weeks after initiation of PEAR intervention(s)|Only including participants with data at each time point||participants|||Number
815447|NCT01099475|Secondary|Hepatocellular Damage Reflected by Alanine Aminotransferase (ALAT) Levels|At specific time points before, during and after liver surgery, plasma samples will be obtained to analyse the amount of hepatocellular damage reflected by ALAT level. These timepoints include: baseline (before operation), just before intermittent pedicle clamping, just before end of 15 or 30 minutes pedicle clamping, end of 5 minutes reperfusion, end of liver surgery, 8 hours after start liver surgery, postoperative day 1, 2 and 3.|ALAT area under curve from start of surgery up until postoperative day 3|||IU*h/L||Standard Error|Mean
815448|NCT01099475|Secondary|Amount of Blood Loss|amount of blood in the suction container (and, if applicable, in the weighted gauzes)|at the end of liver surgery, an average of 225 minutes|||mL||Full Range|Median
815449|NCT01099475|Secondary|Post-resectional Complications|morbidity and mortality occuring after liver surgery graded according to Clavien-Dindo's grading system. In short, any deviation from the postoperative course without the need for pharmacological, radiological or surgical intervention was classified as Clavien-Dindo grade 1; complications requiring pharmacological treatment were graded as grade 2; complications requiring surgical or radiological intervention not under general anesthesia as grade 3a and under general anesthesia as grade 3b; grade 4 complications were life-threatening complications requiring intensive care unit care because of single organ dysfunction (grade 4a) or multiple organ dysfunction (grade 4b); mortality was classed as grade 5.|within 90-days after initial liver surgery|||participants|||Number
815450|NCT01099475|Primary|Hepatocellular Damage Reflected by Liver Fatty-acid Binding Protein (L-FABP) Levels|At specific time points before, during and after liver surgery, plasma samples will be obtained to analyse the amount of hepatocellular damage reflected by L-FABP) level. These timepoints include: baseline (before operation), just before intermittent pedicle clamping, just before end of 15 or 30 minutes pedicle clamping, end of 5 minutes reperfusion, end of liver surgery, 8 hours after start liver surgery, postoperative day 1, 2 and 3. This continuous variable with repeated measurements was summarized as area under the curve (AUC) from baseline to postoperative day 3 (as described in Matthews JN, Altman DG, Campbell MJ, Royston P. Analysis of serial measurements in medical research. Bmj 1990;300:230-5).|L-FABP area under curve from start of surgery up until postoperative day 3|||ng*h/mL||Standard Error|Mean
815451|NCT01099579|Secondary|Apparent Total Body Clearance Per Body Weight (CLT/F) Per Kilogram of Atazanavir and Ritonavir|Calculated as CLT/F divided by body weight|At Week 2|All participants who had received study drug and had adequate pharmacokinetic profiles (n=number evaluable)||L/h per kilogram||Full Range|Geometric Mean
815452|NCT01099579|Secondary|Apparent Total Body Clearance (CLT/F) of Atazanavir and Ritonavir|Calculated as dose divided by AUC(TAU). AUC(TAU)=area under the concentration-time curve in 1 dosing interval from time 0 to 24 hours post observed dose.|At Week 2|All participants who had received study drug and had adequate pharmacokinetic profiles (n=number evaluable)||L/h||Full Range|Geometric Mean
815453|NCT01099579|Secondary|Time to Maximum Observed Concentration (Tmax) of Atazanavir and Ritonavir||At Week 2 at Hour 0 predose and at Hours 1.5, 2.5, 4, 6, 8, 12, and 24 postdose|All participants who had received study drug and had adequate pharmacokinetic profiles (n=number evaluable)||Hours||Full Range|Median
815454|NCT01099579|Secondary|Area Under the Concentration Curve (in 1 Dosing Interval From Time 0 to 24 Hours Post Observed Dose) (AUC[TAU])of Atazanavir and Ritonavir||At Week 2 at Hour 0 predose and at Hours 1.5, 2.5, 4, 6, 8, 12, and 24 postdose|All participants who had received study drug and had adequate pharmacokinetic profiles (n=number evaluable)||ng*h/mL||Full Range|Geometric Mean
815455|NCT01099579|Secondary|Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) of Atazanavir and Ritonavir||At Week 2 at Hour 0 predose and at Hours 1.5, 2.5, 4, 6, 8, 12, and 24 postdose|All participants who had received study drug and had adequate pharmacokinetic profiles (n=number evaluable)||ng/mL||Full Range|Geometric Mean
815456|NCT01099579|Secondary|Number of Participants Who Acquired Phenotypic Resistance to Atazanavir or Atazanovir/Ritonavir|Criteria for resistance testing= meeting at least 1 of the following: <1 log10 drop from baseline in HIV RNA level by Week 16 and confirmed by a second HIV RNA level; an HIV RNA level >200 copies/mL after Week 24, confirmed by a second HIV RNA level; repeated HIV RNA levels ≥50 copies/mL after Week 48; an HIV RNA level ≥400 copies/mL confirmed by a second HIV RNA level of ≥400 copies/mL at any time in a participant who had previously achieved a plasma HIV RNA level <50 copies/mL; or discontinued due to lack of efficacy. Virologic failure was defined as an incomplete virologic response to therapy or as a viral rebound after the achievement of virologic suppression. The phenotypic resistance to a drug is defined as a fold change (ie, ratio of the 50% inhibitory concentration [IC50] of the clinical isolate to the IC50 of the reference strain) greater than the cut-off for reduced susceptibility.|From Day 1 to Week 48|Participants who met the criteria for virologic failure||Participants|||Number
815457|NCT01099579|Secondary|Mean CD4 Percent Changes From Baseline at Week 48 by Antiretroviral (ARV) Treatment Status||From Baseline to Week 48|Participants who received at least 1 dose of atazanavir (ATV) and who had CD4 percent at baseline and Week 48 while taking ATV powder||Percentage of lymphocytes||Standard Error|Mean
816939|NCT01116921|Secondary|Duration of Oxygen Therapy||During first seven days of life|||hours||Standard Deviation|Mean
816940|NCT01116921|Secondary|Duration of CPAP Therapy||During first seven days of life|||hours||Standard Deviation|Mean
815460|NCT01099579|Primary|Number of Participants With Centers for Disease Control (CDC) Class C AIDS Events|CDC Class C events are AIDS-defining events that include recurrent bacterial pneumonia (>=2 episodes in 12 months); candidiasis of the bronchi, trachea, lungs, or esophagus; invasive cervical carcinoma; disseminated or extrapulmonary coccidioidomycosis; extrapulmonary cryptococcosis; chronic intestinal cryptosporidiosis (>1 month); cytomegalovirus disease; HIV-related encephalopathy; herpes simplex: chronic ulcers, or bronchitis, pneumonitis, or esophagitis; disseminated or extrapulmonary histoplasmosis; chronic intestinal isosporiasis; Kaposi sarcoma; immunoblastic or primary brain Burkitt lymphoma; mycobacterium avium complex, kansasii, or tuberculosis; mycobacterium, other species; Pneumocystis carinii pneumonia; progressive multifocal leukoencephalopathy; Salmonella septicemia; recurrent toxoplasmosis of brain; HIV wasting syndrome (involuntary weight loss >10% of baseline body weight) with chronic diarrhea or chronic weakness and documented fever for ≥1 month.|From Day 1 to Week 48|||Participants|||Number
815461|NCT01099579|Primary|Electrocardiogram Changes From Baseline in PR Interval, QTC Bazett, and QTC Fridericia at Week 48||From Baseline to Week 48|All participants who received at least 1 dose of atazanavir and were evaluable||Milliseconds||Standard Deviation|Mean
815462|NCT01099579|Primary|Number of Participants With Laboratory Test Results With Worst Toxicity of Grade 3-4|ALT=alanine aminotransferase; SGPT=serum glutamic-pyruvic transaminase; AST=aspartate aminotransferase; SGOT=serum glutamic-oxaloacetic transaminase; ULN=upper limit of normal. Grading by the National Institute of Health Division of AIDs and World Health Organization criteria. Hemoglobin (g/dL): Grade (Gr)1=9.5-11.0; Gr 2=8.0-9.4; Gr 3=6.5-7.9; Gr 4=<6.5. Neutrophils, absolute (/mm^3): Gr 1=>=1000-<1500; Gr 2= >=750-<1000; Gr 3=>=500-<750; Gr 4=<500. ALT/SGPT (*ULN): Gr 1=1.25-2.5; Gr 2=2.6–5; Gr 3=5.1-10; Gr 4=>10. AST/SGOT (*ULN): Gr 1=1.25-2.5; Gr 2=2.6-5; Gr 3=5.1-10; Gr 4=>10. Alkaline phosphatase(*ULN): Gr 1=1.25-2.5; Gr 2=2.6–5: Gr 3=5.1-10; Gr 4=>10. Total bilirubin (*ULN): Gr 1=1.1-1; Gr 2=1.6-2.5; Gr 3=2.6-5; Gr 4=>5. Amylase (*ULN): Gr 1=1.10-39; Gr 2=1.40-2; Gr 3=2.10-5.0; Gr 4=>5.0. Lipase (*ULN): Gr 1=1.10-1.39: Gr 2=1.40-2; Gr 3=2.10-5.0; Gr 4=>5.0. Uric acid (mg/dL): Gr 1=7.5-10.0; Gr 2=10.1-12.0; Gr 3=12.1-15.0; Gr 4=>15.|From Day 1 to Week 48|All participants who received at least 1 dose of atazanavir; n=number of evaluable participants.||Participants|||Number
815463|NCT01099579|Secondary|CD4 Cell Count Changes From Baseline at Week 48 by Treatment/Weight||From Baseline to Week 48|Participants who received at least 1 dose of atazanavir (ATV) and who had CD4 at baseline and Week 48 while taking ATV powder||Cells/mm^3||Standard Error|Mean
815464|NCT01099579|Secondary|Mean Change From Baseline in HIV RNA Levels at Week 48 by Prior Antiretroviral (ARV) Treatment Status||From Baseline to Week 48|Participants who received at least 1 dose of atazanavir (ATV) and who had an HIV RNA measurement on ATV powder at Week 48||Log10 c/mL||Standard Error|Mean
815465|NCT01099579|Secondary|Mean Change From Baseline in HIV RNA Levels at Week 48 by Treatment/Weight|Participants who received at least 1 dose of atazanavir (ATV) and had an HIV RNA measurement on ATV powder at did not switch to the capsule formulation before Week 48|From Baseline to Week 48|Participants who received at least 1 dose of atazanavir and who had HIV RNA while taking atazanavir powder at Week 48||Log10 c/mL||Standard Error|Mean
815466|NCT01099579|Secondary|Percentage of Participants With HIV RNA Levels <50 c/mL and <400 c/mL at Week 48 by Prior Antiretroviral (ARV) Treatment Status|The definition of virologic success included HIV RNA levels <50 c/mL or <400 c/mL at the Week 48 analysis.|From Day 1 to Week 48|Participants who received at least 1 dose of atazanavir (ATV) and who did not switch to the ATV capsule formulation on or before Week 48||Percentage of participants|||Number
815467|NCT01099579|Secondary|Percentage of Participants With HIV RNA Levels <50 c/mL and <400 c/mL at Week 48 by Treatment/Weight|The definition of virologic success included HIV RNA levels <50 c/mL or 400 c/mL at the Week 48 analysis window.|From Day 1 to Week 48|Participants who received at least 1 dose of atazanavir and who did not switch to the capsule formulation at or before Week 48||Percentage of participants|||Number
815468|NCT01099579|Primary|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|From Day 1 to Week 48|All participants who received at least 1 dose of active atazanavir powder.||Participants|||Number
815469|NCT01099618|Primary|Length of Remission|For those patients that are able to discontinue insulin therapy at or <12 weeks, how long were they able to well controlled with an A1c <7% on the agent that they were randomized to.|3 years|||days||Full Range|Median
815470|NCT01099709|Primary|AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration|Bioequivalence based on AUC0-t|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects who experienced emesis within 12 hours after dosing were excluded from PK analysis.||ng*h/mL||Standard Deviation|Mean
815471|NCT01099709|Primary|AUC0-inf - Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over a 72-hour time period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects who experienced emesis within 12 hours after dosing were excluded from PK analysis.||ng*h/mL||Standard Deviation|Mean
815472|NCT01099709|Primary|Cmax - Maximum Observed Plasma Concentration|Bioeqivalence based on Cmax.|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects who experienced emesis within 12 hours after dosing were excluded from PK analysis.||ng/mL||Standard Deviation|Mean
815473|NCT01099761|Secondary|Change in Pulmonary Function Test (MEP)|Maximum Expiratory Pressure (MEP); 3 of 3 separate tests employed to assess pulmonary function in this study|Baseline to End-of-Stuidy Visit, approximately 24 weeks|||cm H2O||Standard Deviation|Mean
815474|NCT01099761|Secondary|Change in Pulmonary Function Test (MIP)|Maximum Inspiratory Pressure (MIP); 2 of 3 separate tests employed to assess pulmonary function in this study|Baseline to End-of-Study Visit. approximately 24 weeks|||cm H2O||Standard Deviation|Mean
815478|NCT01099761|Secondary|Percent Change in Muscle Strength Score by Hand-held Myometry.|Manual Muscle Testing (MMT) is a procedure to measure the function and strength of individual muscles and muscle groups. Hand-held myometry, using a device known as a dynamometer, is one method used for MMT. The dynamometer is held against the patient's limb by the examiner and the patient is asked to resist the force applied by the examiner. The dynamometer measures the force applied by the patient, providing a quantitative and objective assessment of strength of the particular muscle or muscle group. The effectiveness of a therapeutic intervention on muscle strength, as measured by hand-held myometry, can be assessed by comparing post-treatment to pre-treatment (baseline) measurements.|Baseline to End-of-Study Visit, approximately 24 weeks later.|||percentage change from baseline||Standard Deviation|Mean
815479|NCT01099761|Secondary|Percent Change in Lumbar Spine Bone Mineral Density by DXA Scan.||Baseline to End-of-Study Visit, approximately 24 weeks later.|||percentage change from baseline||Standard Error|Mean
815480|NCT01099761|Secondary|Percent Change in Total Lean Body Mass by DXA Scan.||Baseline to End-of-Study Visit, approximately 24 weeks later.|||percentage change in lean body mass||Standard Error|Mean
815481|NCT01099761|Primary|Number of Subjects With Clinical Laboratory Adverse Reactions.|Number of subjects in each cohort with treatment-emergent adverse laboratory values judged to be at least possibly related to study drug|Baseline to End-of-Study Visit, approximately 24 weeks later.|||Number of subjects|||Number
815482|NCT01099761|Primary|Number of Subjects With Adverse Reactions.|Number of subjects in each cohort with a treatment-emergent adverse event considered at least possibly related to study drug|From treatment initiation to End-of-Study Visit, approximately 24 weeks later|||Number of subjects|||Number
815483|NCT01099774|Primary|Average Eye IOP at Week 2|Average Eye IOP at Week 2 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported.|Week 2|Intent to Treat Population: all randomized patients.||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
815484|NCT01099774|Primary|Average Eye IOP at Week 6|Average Eye IOP at Week 6 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported.|Week 6|Intent to Treat Population: all randomized patients.||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
815485|NCT01099774|Primary|Average Eye IOP at Week 12|Average Eye IOP at Week 12 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported. Baseline data are included for reference only.|Baseline, Week 12|Intent to Treat Population: all randomized patients.||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
815486|NCT01099774|Primary|Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Week 12|Change from baseline in worse eye IOP at Week 12 . IOP is a measurement of fluid pressure inside the eye. IOP measurements in the worse eye were evaluated at hours 0, 2, and 8. A negative number change from baseline indicated a reduction in IOP, and a positive number change from baseline indicated an increase in IOP.|Baseline, Week 12|Per Protocol Population: All randomized patients who did not have a protocol violation that significantly affected the conduct or the results of the trial.||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
815487|NCT01099917|Primary|Changes in Neutrophil Counts|The main criterion for study response is ability of the study agent to show a statistically significant improvement in neutrophil count and neutrophil function (as measured by the respiratory burst test). Changes in neutrophil counts will also be described as defined by the International Working Group (IWG) criteria for response in MDS patients|baseline and week 12|||cells/mm^3||95% Confidence Interval|Mean
815488|NCT01100073|Secondary|Number of Premature Discontinuations|Number of patients discontinuing the study prematurely|Week 0 to weeks 9-16 (end of study)|Total patients||Participants|||Number
815489|NCT01100073|Secondary|Incidence, Relationship and Seriousness of Adverse Events|Total number of adverse events (AEs), causality and level of seriousness|Week 0 to weeks 9-16 (end of study)|Total patients||Number of events|||Number
815490|NCT01100073|Secondary|Change in Tremor Score (UPDRS Items 16, 20, 21) at the End of Up-titration|Change (reduction) from baseline in tremor score, derived from UPDRS from baseline to Visit 2. Score ranging from 0 - 32 (0=no tremor, 32=high tremor)|Enter Week 0 to weeks 1-8 (Visit 2)|Patients for whom baseline and Visit 2 UPDRS Part II and III scores available||Points on a UPDRS scale||Standard Deviation|Mean
815491|NCT01100073|Secondary|Change From Baseline in UPDRS Part III Score at the End of Up-titration|Change (reduction) in UPDRS Part III score (motor function) from baseline to Visit 2. Score ranging from 0 - 108 (0=no disability, 108=maximum disability)|Enter Week 0 to weeks 1-8 (Visit 2)|Patients for whom baseline and Visit 2 UPDRS Part III scores available||Points on a UPDRS scale||Standard Deviation|Mean
815492|NCT01100073|Secondary|Change From Baseline in UPDRS Part II Score at the End of Up-titration|Change (reduction) in UPDRS Part II score (activities of daily living) from baseline to Visit 2. Score ranging from 0 - 52 (0=no disability, 52=maximum disability)|Enter Week 0 to weeks 1-8 (Visit 2)|Patients for whom baseline and Visit 2 UPDRS Part II scores available||Points on a UPDRS scale||Standard Deviation|Mean
815493|NCT01100073|Secondary|Final Dose Distribution|Final Mirapexin® dose distribution at the end of study|Enter Week 0 to weeks 9-16 (Visit 3)|Total patients. Number of participants analysed differs for each outcome measure because not all evaluations were performed / documented on every patient.||milligrams of Mirapexin® (salt)||Full Range|Median
815494|NCT01100073|Primary|Change From Baseline in 39 Item Parkinson's Disease Questionnaire (PDQ-39) Score at the End of Maintenance|Change (reduction) in PDQ-39 score (quality of life) from baseline to end of study. Score ranging from 0-100 (0=perfect health, 100=worst health as assessed by the measure)|Week 0 to weeks 9-16 (Visit 3)|Full analysis set (FAS) - Patients for whom baseline and end of study PDQ-39 score available||unit on a scale||Standard Deviation|Mean
815495|NCT01100073|Primary|Change From Baseline in Tremor Score From UPDRS (Items 16, 20, 21) at the End of Maintenance (Visit 3)|Change (reduction)in tremor score from baseline to end of study. Score ranging from 0 - 32 (0=no tremor, 32=high tremor)|Week 0 to weeks 9-16 (Visit 3)|Full analysis set (FAS) - Patients for whom baseline and end of study UPDRS tremor score (UPDRS items 16, 20, 21) available||Points on UPDRS scale||Standard Deviation|Mean
817592|NCT01112579|Primary|Evaluate the Reduction in Left-ventricular End Systolic Volume Index (LVESVi) After 6 Months of Spinal Cord Stimulation (SCS) Therapy in the Treatment Arm Compared to the Control Arm.||Baseline and 6 months|||mL/m2||Standard Deviation|Mean
815498|NCT01100073|Primary|Change From Baseline in UPDRS Part III Score at the End of Maintenance|Change (reduction) in UPDRS Part III score (motor function) from baseline to end of study. Score ranging from 0 - 108 (0=no disability, 108=maximum disability)|Week 0 to weeks 9-16|Full analysis set (FAS) - Patients for whom baseline and end of study UPDRS Part III scores available||Points on UPDRS scale||Standard Deviation|Mean
815499|NCT01100073|Primary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at the End of Maintenance|Change (reduction) in UPDRS Part II score (activities of daily living) from baseline to end of study. Score ranging from 0 - 52 (0=no disability, 52=maximum disability)|Week 0 to weeks 9-16 (Visit 3)|Full analysis set (FAS) - Patients for whom baseline and end of study UPDRS Part II scores available||Points on UPDRS scale||Standard Deviation|Mean
815500|NCT01100086|Primary|AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration|AUC0-t is the area under the plasma concentration-time curve from time zero to time of last non-zero plasma concentration and bioequivalence is based on AUC0-t.|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects who experienced emesis within 12 hours after dosing were excluded from PK analysis.||ng*h/mL||Standard Deviation|Mean
815501|NCT01100086|Primary|AUC0-inf - Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)|AUC0-inf is the area under the plasma concentration-time curve from time zero to infinity (extrapolated) and bioequivalence is based on AUC0-inf.|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects who experienced emesis within 12 hours after dosing were excluded from PK analysis.||ng*h/mL||Standard Deviation|Mean
815502|NCT01100086|Primary|Cmax - Maximum Observed Plasma Concentration|Cmax is the maximum observed plasma concentration and bioequivalence is based on Cmax.|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects who experienced emesis within 12 hours after dosing were excluded from PK analysis.||ng/mL||Standard Deviation|Mean
815503|NCT01100112|Secondary|Endoscopic Improvement|"Greater or equal to a 1 point improvement in the mucosal appearance subscore of the ulcerative colitis disease activity index (UCDAI), from baseline to week 8.
The UCDAI mucosal appearance subscore is graded as follows: 0 = normal, 1 = mild friability, 2 = moderate friability, 3 = exudation, spontaneous bleeding."|8 weeks|All patients who received at least one dose of study drug.||percentage of patients|||Number
815504|NCT01100112|Secondary|Safety Evaluations: the Numbers of Patients Who Experience Serious Adverse Events (SAEs) or Other Nonserious Adverse Events (AEs) During the Course of the Study.|Safety will be assessed by evaluating SAEs and AEs. The outcome measure data are the numbers of patients who experienced SAEs or other nonserious AEs.|Throughout the 8 week treatment period|All patients who received at least 1 dose of study drug.||participants|||Number
815505|NCT01100112|Secondary|The Secondary Efficacy Endpoint is Clinical Improvement|The secondary efficacy endpoint is clinical improvement, defined as a drop in the Ulcerative Colitis Disease Activity Index score of > or = 3 points from baseline.|After 8 weeks treatment period|All patients who received at least 1 dose of study drug.||percentage of patients|||Number
815506|NCT01100112|Primary|The Percentage of Patients Achieving Clinical Remission|"The primary efficacy endpoint is clinical remission at 8 weeks, defined as a Ulcerative Colitis Disease Activity Index score of < or = 1 with a score of 0 for both rectal bleeding and stool frequency, and > or = 1 point reduction from baseline in endoscopy score, without any sign of mucosal friability (a score of 0 for mucosal appearance).
The UCDAI has 4 components. Each component is scored on scale of 0 to 3 (total maximum [worst] score = 12). Definitions of component scores are as follows: stool frequency: 0 = normal frequency, 1 = 1 - 2 stools per day greater than normal frequency, 2 = 3 - 4 stools per day greater than normal frequency, and 3 = > 4 stools per day greater than normal frequency; rectal bleeding: 0 = none, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood; physician's rating of disease activity: 0 = normal, 1 = mild, 2 = moderate, 3 = severe; mucosal appearance: 0 = normal, 1 = mild friability, 2 = moderate friability, 3 = exudation, spontaneous bleeding."|At the end of the 8 week treatment period|All patients who received at least 1 dose of study drug.||percentage of patients|||Number
815507|NCT01100242|Secondary|Toxicity Profile|Toxicity is assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Toxicity profile is reported as the number of patients who received at least one dose of on-study treatment and experienced a grade 3 or grade 4 adverse event (AE). For a more complete listing of all AEs experienced by patients on study, please see the Adverse Event section.|42 days|||participants|||Number
815508|NCT01100242|Secondary|Overall Response Rate (ORR)|Tumor response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI:) Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions. Overall response rate (ORR) is the percentage of patients who achieve a CR or PR|42 days|||percentage of participants|||Number
815509|NCT01100242|Primary|Progression Free Survival (PFS)|Progression free survival will be measured from the beginning of treatment until there is evidence of progressive disease or death from any cause. Progression is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI): Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|36 weeks|||weeks||Full Range|Median
815510|NCT01100255|Primary|Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale.|Patients given YBOCS (Yale Brown Obsessive-Compulsive Scale), a gold standard measure of obsessions and compulsions. For the YBOCS the minimum units are 0 and Maximum units on the total scale are 40. The higher the number on the YBOCS, the more severe the symptoms. Response was defined as at least a 35% reduction on the YBOCS.|1 week|||participants|||Number
817593|NCT01112670|Other Pre-specified|Atorvastatin Maximum Plasma Concentration (Cmax)||0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose|The population analyzed included participants who completed both periods of the pharmacokinetic crossover study.||ng/ml||Standard Deviation|Mean
815511|NCT01100268|Secondary|Number of Patients Who Met Response Criteria for the Saving Inventory-Revised.|Patients given Saving Inventory-Revised (SI-R), an evidence-based measure of three features of hoarding: excessive acquisition, difficulty discarding, and clutter. For the SI-R the minimum units are 0 and Maximum units on the total scale are 92. The higher the number on the SI-R, the more severe the symptoms. Response was defined as at least a 25% reduction on the SI-R.|4 weeks|||participants|||Number
815512|NCT01100268|Primary|Number of Patients Who Met and Exceeded Response Criteria of Attention Deficit Hyperactivity Disorder Symptom Scale|Patients given Attention Deficit Hyperactivity Disorder Symptom Scale (ADHDSS), a measure of the features of Attention Deficit Hyperactivity Disorder including inattention, hyperactivity, and impulsivity. This scale has shown excellent reliability in prior studies of individuals with HD. For the ADHDSS the minimum units are 0 and Maximum units on the total scale are 54 (adult). The higher the number on the ADHDSS, the more severe the symptoms. Response was defined as at least a 30% reduction on the ADHDSS.|4 weeks|||participants|||Number
815513|NCT01100307|Other Pre-specified|Change From Baseline in The 25-Item National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Composite Score/Sub-scale Score at Week 54: Open Phase|"NEI-VFQ 25, Japanese version v.1.4 for self-administering questionnaires consisted of the base set of 25 questions and 12 subscale scores.
Response categories to each question were converted to a 0 to 100 scale so that the lowest and highest possible scores were set at 0 and 100 points, respectively. A higher score represented better functioning. Questions within each sub-scale were averaged together to create the 12 sub-scale scores. The overall composite score was calculated by averaging the vision-targeted subscale scores excluding the general health-rating question.
Positive change indicated improvement."|Baseline and Week 54|Full Analysis Set 2: participants who received at least 1 injection and had VA assessments both at baseline and at least once at post-dose in open phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).||Units on a scale||Standard Deviation|Mean
815514|NCT01100307|Other Pre-specified|Number of Participants Exhibiting a Decrease From Baseline in Retinal Thickness at the Center Point by ≥25 Percent and ≥50 Percent Using Optical Coherence Tomography (OCT) at Week 54: Open Phase|Retinal thickness was assessed by spectral-domain optical coherence tomography or OCT3000, a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|Baseline and Week 54|Full Analysis Set 2: participants who received at least 1 injection and had VA assessments both at baseline and at least once at post-dose in open phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).||Participants|||Number
815515|NCT01100307|Other Pre-specified|Number of Participants Who Experience a ≥15, ≥5, or ≥0 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline at Week 54: Open Phase|Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.|Baseline and Week 54|Full Analysis Set 2: participants who received at least 1 injection and had VA assessments both at baseline and at least once at post-dose in open phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).||Participants|||Number
815516|NCT01100307|Other Pre-specified|Number of Participants Who Experience a ≥10 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline: Open Phase|Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.|Baseline, Weeks 30, 36, 42, 48, and 54|Full Analysis Set 2: participants who received at least 1 injection and had VA assessments both at baseline and at least once at post-dose in open phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).||Participants|||Number
815517|NCT01100307|Other Pre-specified|Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase|"Best-corrected VA measurements were performed using retro-illuminated, modified Ferris-Bailey ETDRS charts.
Change from baseline in VA was categorized as follows: Lost 15 letters or more; Lost 10 – 14 letters; Lost 1 - 9 Letters; No change or gained 1 – 9 letters; Gained 10 – 14 letters; Gained 15 letters or more."|Baseline, Weeks 30, 36, 42, 48, and 54|Full Analysis Set 2: participants who received at least 1 injection and had VA assessments both at baseline and at least once at post-dose in open phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).||Participants|||Number
815518|NCT01100307|Other Pre-specified|Mean Visual Acuity Over Time at Each Time Point: Open Phase|Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.|Baseline, Weeks 30, 36, 42, 48, and 54|Full Analysis Set 2: participants who received at least 1 injection and had VA assessments both at baseline and at least once at post-dose in open phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).||Letters||Standard Deviation|Mean
815519|NCT01100307|Other Pre-specified|Change From Baseline in National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Composite Score/Sub-scale Score at Week 24: Double Masked Phase|"NEI-VFQ 25, Japanese version v.1.4 for self-administering questionnaires consisted of the base set of 25 questions and 12 subscale scores.
Response categories to each question were converted to a 0 to 100 scale so that the lowest and highest possible scores were set at 0 and 100 points, respectively. A higher score represented better functioning. Questions within each sub-scale were averaged together to create the 12 sub-scale scores. The overall composite score was calculated by averaging the vision-targeted subscale scores excluding the general health-rating question.
Positive change indicated improvement."|Baseline and Week 24|Full Analysis Set 1: participants who received at least 1 injection after randomized to study treatment and had VA assessments both at baseline and at least once at post-dose in the double-masked phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).||Units on a scale||Standard Deviation|Mean
815531|NCT01100320|Primary|AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration|Bioequivalence based on AUC0-t|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects who experienced emesis within 12 hours after dosing were excluded from PK analysis||ng*h/mL||Standard Deviation|Mean
815520|NCT01100307|Other Pre-specified|Number of Participants Exhibiting a Decrease From Baseline in Retinal Thickness at the Center Point by ≥25 Percent and ≥50 Percent Using Optical Coherence Tomography (OCT) at Week 24: Double Masked Phase|OCT, a noninvasive, noncontact, transpupillary imaging technology, was utilized to image retinal structures in vivo. The anatomic layers within the retina, retinal thickness could be measured.|Baseline and Week 24|Full Analysis Set 1: participants who received at least 1 injection after randomized to study treatment and had VA assessments both at baseline and at least once at post-dose in the double-masked phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).||Participants|||Number
815521|NCT01100307|Other Pre-specified|Number of Participants Who Experience a ≥15, ≥5, or ≥0 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline at Week 24: Double Masked Phase|Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.|Baseline and Week 24|Full Analysis Set 1: participants who received at least 1 injection after randomized to study treatment and had VA assessments both at baseline and at least once at post-dose in the double-masked phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).||Participants|||Number
815522|NCT01100307|Other Pre-specified|Number of Participants Who Experience a ≥10 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline: Double Masked Phase|Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.|Baseline, Weeks 6, 12, 18, and 24|Full Analysis Set 1: participants who received at least 1 injection after randomized to study treatment and had VA assessments both at baseline and at least once at post-dose in the double-masked phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).||Participants|||Number
815523|NCT01100307|Other Pre-specified|Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase|"Best-corrected VA measurements were performed using retro-illuminated, modified Ferris-Bailey ETDRS charts.
Change from baseline in VA was categorized as follows: Lost 15 letters or more; Lost 10 – 14 letters; Lost 1 - 9 Letters; No change or gained 1 – 9 letters; Gained 10 – 14 letters; Gained 15 letters or more."|Baseline, Weeks 6, 12, 18, and 24|Full Analysis Set 1: participants who received at least 1 injection after randomized to study treatment and had VA assessments both at baseline and at least once at post-dose in the double-masked phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).||Participants|||Number
815524|NCT01100307|Other Pre-specified|Mean Visual Acuity Over Time at Each Time Point: Double Masked Phase|Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.|Baseline, Weeks 6, 12, 18, and 24|Full Analysis Set 1: participants who received at least 1 injection after randomized to study treatment and had VA assessments both at baseline and at least once at post-dose in the double-masked phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).||Letters||Standard Deviation|Mean
815525|NCT01100307|Secondary|Number of Participants Who Underwent Focal/Grid Laser, or Vitrectomy: Open Phase|Included focal laser photocoagulation, grid laser photocoagulation, and vitrectomy.|Weeks 24 to 54|Full Analysis Set 2: participants who received at least 1 injection and had VA assessments both at baseline and at least once at post-dose in open phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).||Participants|||Number
815526|NCT01100307|Secondary|Change From Baseline in Visual Acuity (VA): Open Phase|Changes in VA were monitored through refraction and best-corrected VA measurements using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.|Baseline, Weeks 30, 36, 42, 48 and 54|Full Analysis Set 2: participants who received at least 1 injection and had VA assessments both at baseline and at least once at post-dose in open phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).||Letters||Standard Deviation|Mean
815527|NCT01100307|Secondary|Number of Participants Who Experience a ≥10 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline at Week 54: Open Phase|Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.|Baseline and Week 54|Full Analysis Set 2: participants who received at least 1 injection and had VA assessments both at baseline and at least once at post-dose in open phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).||Participants|||Number
815528|NCT01100307|Secondary|Number of Participants Underwent Focal/Grid Laser, or Vitrectomy: Double Masked Phase|Included focal laser photocoagulation, grid laser photocoagulation, and vitrectomy.|Up to 24 weeks|Full Analysis Set 1: participants who received at least 1 injection after randomized to study treatment and had VA assessments both at baseline and at least once at post-dose in the double-masked phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).||Participants|||Number
815529|NCT01100307|Secondary|Change From Baseline in Visual Acuity (VA): Double Masked Phase|Changes in VA were monitored through refraction and best-corrected VA measurements using retro-illuminated, modified Ferris-Bailey ETDRS charts|Baseline, Weeks 6, 12, 18, and 24|Full Analysis Set 1: participants who received at least 1 injection after randomized to study treatment and had VA assessments both at baseline and at least once at post-dose in the double-masked phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).||Letters||Standard Deviation|Mean
815530|NCT01100307|Primary|Number of Participants Who Experience a ≥10 Letter Improvement of Visual Acuity (VA) in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline at Week 24: Double Masked Phase|Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.|Baseline and Week 24|Full Analysis Set 1: participants who received at least 1 injection after randomized to study treatment and had VA assessments both at baseline and at least once at post-dose in the double-masked phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).||Participants|||Number
815532|NCT01100320|Primary|AUC0-inf - Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects who experienced emesis within 12 hours after dosing were excluded from PK analysis.||ng*h/mL||Standard Deviation|Mean
815533|NCT01100320|Primary|Cmax - Maximum Observed Plasma Concentration|Bioequivalence based on Cmax|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects who experienced emesis within 12 hours after dosing were excluded from PK analysis.||ng/mL||Standard Deviation|Mean
815534|NCT01100437|Other Pre-specified|Maximum Post-dose COWS in the Treatment Phase|COWS is an 11 section clinical assessment of withdrawal symptoms, each section is rated from 0 (no symptom) to 4 or 5 (most severe symptom). Total score is classified into a 4 point rating scale (mild 5-12, moderate 13-24, moderately severe 25-36 and severe more than 36 points).|Between 0.5 and 24 hours post-dose|ITT||units on a scale||Standard Deviation|Mean
815535|NCT01100437|Other Pre-specified|6-β-Naltrexone Plasma Concentration at First COWS ≥ 13 in Treatment Phase||Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose|ITT; Subset of all participants with COWS ≥ 13||pg/mL||Standard Deviation|Mean
815536|NCT01100437|Other Pre-specified|Naltrexone Plasma Concentration at First COWS ≥ 13 in the Treatment Phase||Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose|ITT; Subset of participants with COWS ≥ 13||picogram/milliliter (pg/mL)||Standard Deviation|Mean
815537|NCT01100437|Other Pre-specified|Morphine Plasma Concentration at First COWS ≥ 13 in the Treatment Phase||Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose|ITT; Subset of participants with COWS ≥ 13||ng/mL||Standard Deviation|Mean
815538|NCT01100437|Other Pre-specified|Time to First Occurrence of a COWS Score ≥ 13 for Each Treatment During the Treatment Phase|Average time to first occurrence of a COWS score ≥ 13|Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24 hr post-dose and UA|ITT; Subset of participants with COWS >= 13||h||Standard Error|Mean
815539|NCT01100437|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] During the Treatment Phase|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). Average AUC 0-∞ for Morphine, Naltrexone and 6-β-Naltrexol reported.|Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose|PK population; N=number of participants with evaluable data; n=number of participants with evaluable data for the specific category||ng*h/mL||Standard Deviation|Mean
815540|NCT01100437|Secondary|Area Under the Curve From Time Zero to the Time of Last Measurable Concentration (AUC0-last) During the Treatment Phase|Average AUC0-last for Morphine, Naltrexone and 6-β-Naltrexol. Area under the plasma concentration time-curve from time zero to the last measured concentration.|Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose|PK population; n=number of participants with evaluable data for the specific category||ng*h/mL||Standard Deviation|Mean
815541|NCT01100437|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUC0-τ) During the Treatment Phase|Average AUC0-τ for Morphine, Naltrexone and 6-β-Naltrexol reported. τ=24 hours|Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose|PK population; n=number of participants with evaluable data for the specific category||ng times h divided by mL (ng*h/mL)||Standard Deviation|Mean
815542|NCT01100437|Secondary|Plasma Decay Half-Life (t1/2) During the Treatment Phase|Average plasma decay half-life of morphine, naltrexone and 6-β-Naltrexol. Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose|PK population; N=number of participants with evaluable data; n=number of participants with evaluable data for the specific category||h||Standard Deviation|Mean
815543|NCT01100437|Secondary|Volume of Distribution (Vd/F)During the Treatment Phase|Average Vd/F for Morphine, Naltrexone and 6-β-Naltrexol|Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose|PK population; N=number of participants with evaluable data; n=number of participants with evaluable date for the specific category||liter (L)||Standard Deviation|Mean
815544|NCT01100437|Secondary|Apparent Oral Clearance (CL/F) During the Treatment Phase|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose|PK population; N=number of participants with evaluable data; n=number of participants with evaluable data for the specific category||liters/hour (L/h)||Standard Deviation|Mean
815545|NCT01100437|Secondary|Minimum Observed Plasma Concentration (Cmin) During the Treatment Phase|Average Cmin for Morphine, Naltrexone and 6-β-Naltrexol|Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose|PK population; n=number of participants with evaluable data for specific category||ng/mL||Standard Deviation|Mean
815546|NCT01100437|Secondary|Maximum Observed Plasma Concentration (Cmax) During the Treatment Phase|Average Cmax for Morphine, Naltrexone and 6-β-Naltrexol|Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose|PK population; n=number of participants with evaluable data for specific category||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
815547|NCT01100437|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) During the Treatment Phase|Average Tmax for Morphine, Naltrexone and 6-β-Naltrexol|Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose|Pharmacokinetic (PK) population: all randomized participants who received at least one dose of EMBEDA (whole or crushed) in the Treatment Phase and had at least one PK assessment completed in the Treatment Phase; n=number of participants with evaluable data for the specific category||hours (h)||Standard Deviation|Mean
824836|NCT01178268|Secondary|Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI||9 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
815549|NCT01100437|Primary|Number of Participants With Clinical Opiate Withdrawal Scale (COWS) Score Greater Than or Equal to (≥) 13 in the Treatment Phase|COWS is an 11 section clinical assessment of withdrawal symptoms, each section is rated from 0 (no symptom) to 4 or 5 (most severe symptom). Total score is classified into a 4 point rating scale (mild 5-12, moderate 13-24, moderately severe 25-36 and severe more than 36 points).|Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24 hours (hr) post-dose and unscheduled assessment (UA)|Intent-to-treat population (ITT): all randomized participants who received at least one dose of double-blind treatment in the Treatment Phase and had at least one post-dose pharmacodynamic assessment completed in the Treatment Phase.||participants|||Number
815550|NCT01092728|Secondary|Progression-Free Survival|Progression-Free Survival (PFS) is defined as the duration of time from start of treatment to date of first evidence of progression or the date of last follow-up for patients who do not progress.|Evaluated every 2 cycles (8 weeks) until disease progression or last follow-up, up to two years|None of the participants in the Resectable arm were evaluable, and one participant in the second Unresectable arm was inevaluable due to early departure from study.||Weeks||Full Range|Median
815551|NCT01092728|Primary|Biologic Response Evaluation of Tumors With and Without Resectable Tumors|"Biologic response defined as either (complete or partial) metabolic tumor response after 7 days dasatinib treatment by positron emission tomography (PET) scan, >/= 25% decrease in Fluorodeoxyglucose (FDG) activity on PET without >15% increase in tumoral Ki-67 expression or >/=25% decrease in tumoral Ki-67 expression without >15% increase in FDG activity on PET scan. Complete Metabolic Response (CMR): FDG-avidity all lesions reduced to background FDG-avidity level. Partial Metabolic Response (PMR): >/=25% decrease in FDG-avidity as represented by change in mean Standardized Uptake Values (SUV) max. SUVmax measured by drawing region of interest slightly outside each lesion corresponding to those on CT image & adjusted for body weight. Measureable disease by PET scan defined as lesions that can be determined to have FDG-avidity of SUVmax of 3 and 2 x background.
PR or CR confirmatory disease assessment performed >4 weeks (28 days) after criteria for response first met."|Assessment at 7 Days with confirmatory disease assessment performed no less than 4 weeks (28 days) afterwards|Of 4 participants in first arm, none were evaluable for response (1 inevaluable, 2 withdrawals, 1 disease progression); and of the second arm, one was inevaluable (withdrawal).||participants|||Number
815552|NCT01092767|Primary|All-cause Mortality Within 30-days of the Index Procedure||30 days|||participants|||Number
815553|NCT01092780|Secondary|Mean Score on SDLP Driving Test for Participants Taking Modafinil Versus Placebo|Study drug was administered at 08:00. Driving performance was measured by the SDLP test which is a 45-minute driving simulation country vigilance test and was performed by participants at 10:00, 12:00 and 14:00. An LS mean of the 2 SDLP driving test results performed at 10:00 and 14:00 was calculated. A lower value is considered a better outcome.|2, 4 and 6 hours post dose|The PP population consisted of all participants who were compliant with the protocol and had available data from at least one treatment period.||Meters||90% Confidence Interval|Least Squares Mean
815554|NCT01092780|Secondary|Mean Sleep Latency Score on the MWT for Participants Taking Modafinil Versus Placebo|Study drug was administered at 08:00. MWT, an objective measure of the participant's ability to maintain wakefulness, was administered at 09:00, 11:00, 13:00 and 15:00. A least squares (LS) mean of the 4 MWTs performed at 09:00, 11:00, 13:00 and 15:00 was calculated. Latency for each MWT is defined as the time to onset of the first 16 continuous seconds of any stage of sleep; if no sleep has been observed according to these rules, then the latency is defined as 30 minutes. A higher MWT value is considered a better outcome.|1, 3, 5 and 7 hours post dose|The PP population consisted of all participants who were compliant with the protocol and had available data from at least one treatment period.||Minutes||95% Confidence Interval|Least Squares Mean
815555|NCT01092780|Secondary|Mean Sleep Latency Score on the MWT for Participants Taking MK-7288 Versus Modafinil|Study drug was administered at 08:00. MWT, an objective measure of the participant's ability to maintain wakefulness, was administered at 09:00, 11:00, 13:00 and 15:00. A least squares (LS) mean of the 4 MWTs performed at 09:00, 11:00, 13:00 and 15:00 was calculated. Latency for each MWT is defined as the time to onset of the first 16 continuous seconds of any stage of sleep; if no sleep has been observed according to these rules, then the latency is defined as 30 minutes. A higher MWT value is considered a better outcome.|1, 3, 5 and 7 hours post dose|The PP population consisted of all participants who were compliant with the protocol and had available data from at least one treatment period.||Minutes||95% Confidence Interval|Least Squares Mean
815556|NCT01092780|Primary|Number of Participants Experiencing Clinical and Laboratory Adverse Events (AEs)|An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of the study drug, is also an AE.|Up to 36 days|All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.||Participants|||Number
815557|NCT01092780|Primary|Mean Score on Standard Deviation of Lane Position (SDLP) Driving Test for Participants Taking MK-7288 Versus Placebo|Study drug was administered at 08:00. Driving performance was measured by the SDLP test which is a 45-minute driving simulation country vigilance test and was performed by participants at 10:00, 12:00 and 14:00. An LS mean of the 2 SDLP driving test results performed at 10:00 and 14:00 was calculated. A lower value is considered a better outcome.|2, 4 and 6 hours post dose|The PP population consisted of all participants who were compliant with the protocol and had available data from at least one treatment period.||Meters||95% Confidence Interval|Least Squares Mean
815558|NCT01092780|Primary|Mean Sleep Latency Score on the Maintenance of Wakefulness Test (MWT) for Participants Taking MK-7288 Versus Placebo|Study drug was administered at 08:00. MWT, an objective measure of the participant's ability to maintain wakefulness, was administered at 09:00, 11:00, 13:00 and 15:00. A least squares (LS) mean of the 4 MWTs performed at 09:00, 11:00, 13:00 and 15:00 was calculated. Latency for each MWT is defined as the time to onset of the first 16 continuous seconds of any stage of sleep; if no sleep has been observed according to these rules, then the latency is defined as 30 minutes. A higher MWT value is considered a better outcome.|1, 3, 5 and 7 hours post dose|The Per-Protocol (PP) population consisted of all participants who were compliant with the protocol and had available data from at least one treatment period.||Minutes||95% Confidence Interval|Least Squares Mean
815561|NCT01092832|Secondary|Percentage of Participants With a Global Response of Success at End of Treatment (EOT)|Global response was determined programmatically based on investigator assessment of clinical and microbiological response. Global response of success was defined as clinical cure or improvement AND microbiological eradication or presumed eradication. Exact 95 percent (%) confidence interval for binomial proportions using Clopper-Pearson method.|EOT (from 7 to 42 days of treatment)|Modified Intent-to-Treat (MITT) Population: all participants who received at least 1 dose of study medication and who have confirmed ICC, EC or participants with EC who do not have confirmation of EC by esophagoscopy, but who had at least confirmation of oropharyngeal candidiasis.||percentage of participants||95% Confidence Interval|Number
815562|NCT01092832|Primary|Percentage of Participants With Adverse Events - Overall Summary|Percentage of participants with adverse events (AEs), serious adverse events (SAEs), severe AEs, who discontinued due to AEs, or who had dose redued or temporarily discontinued due to AEs.|Baseline up to 1 month follow-up|Safety population||percentage of participants|||Number
815563|NCT01092910|Primary|Assessment of Cochlear Function|Comparison of the bone conduction threshold with forehead placement at the 4 month post-activation follow-up compared to the pre-implant bone conduction threshold.|4 and 10 Months Post-Activation|10-month results for difference in BC PTA (pre-implant minus post-Esteem) are shown||dB difference||Standard Error|Mean
815564|NCT01092910|Primary|SADEs|The incidence of Serious Adverse Device Effects (SADE) and the incidence rate of device failures and replacements|10 Months Post-Activation|Includes all events, cumulatively, from enrollment through 10-month followup||events|||Number
815565|NCT01092910|Secondary|Esteem Questionnaire|To gain subject feedback and comments on the use of the Esteem System relative to the pre-implant hearing aid (aided condition) as shown by the Esteem Questionnaire.|4 and 10 Months Post Activatio-||||||
815566|NCT01092910|Secondary|APHAB|To assess whether the Esteem System improves Quality-of-Life when compared to the baseline aided condition as shown by APHAB results|4 and 10 Months Post-Activation||||||
815567|NCT01092910|Secondary|QuickSIN|To assess whether the Esteem System is as effective as or better than the pre-implant hearing aid for improving speech discrimination (intelligibility) as shown by the QuickSIN (speech in noise) test results.|4 and 10 Months Post-Activation||||||
815568|NCT01092910|Secondary|PTA Improvement|Comparison of the 3-frequency (500, 1000, and 2000 Hz) pure-tone average (PTA) using the Esteem System to the PTA measured in the baseline unaided condition|4 and 10 Months Post-Activation|10 month data reported||dB improvement||Standard Error|Mean
815569|NCT01092910|Primary|Word Recognition Score Improvement|Comparison of the word recognition score using the Esteem compared to the pre-implant aided condition|10 Months Post Activation|||improvement in % correct||Standard Error|Mean
815570|NCT01092910|Primary|Word Recognition Score Improvement|Comparison of the word recognition score using the Esteem compared to the pre-implant aided condition|4 Months Post Activation|||improvement in % correct||Standard Error|Mean
815571|NCT01092910|Primary|SRT Improvement|Comparison of the speech reception threshold (SRT) using the Esteem System as compared to the pre-implant aided condition|10 Months Post-Activation|||dB improvement||Standard Error|Mean
815572|NCT01092910|Primary|SRT Improvement|Comparison of the speech reception threshold (SRT) using the Esteem System as compared to the pre-implant aided condition|4 Months Post Activation|||dB improvement||Standard Error|Mean
815573|NCT01092923|Primary|PA t/PA0 Sevo (End Tidal Partial Pressure of Sevoflurane), t=Time (Minutes)|Rate of fall in the end-tidal partial pressure of sevoflurane relative to baseline at 2 minutes (PA2/PA0 sevo) and 5 minutes (PA5/PA0 sevo)|Baseline, 2 minutes, and 5 minutes after emergence|based on data collected during previous pilot study investigating the magnitude of the second gas effect on sevoflurane partial pressures after anaesthesia induction, we expected an effect of roughly similar magnitude would be present during elimination of nitrous oxide.||ratio||Standard Deviation|Mean
815574|NCT01092923|Secondary|Time to Eye Opening|The time to eye opening to command after cessation of inhalational anaesthetic administration|20 Minutes|||Minutes||Standard Deviation|Mean
815575|NCT01092923|Primary|Pa t/Pa0 Sevo (Arterial Partial Pressure of Sevoflurane), t=Time(Minutes)|Rate of fall in the arterial partial pressure of sevoflurane relative to baseline at 2 minutes (Pa 2/Pa0 Sevo), 5 minutes (Pa 5/Pa0 Sevo, and 30 minutes (Pa 30/Pa0 Sevo)|Baseline, 2 minutes, 5 minutes, and 30 minutes after emergence|based on data collected during previous pilot study investigating the magnitude of the second gas effect on sevoflurane partial pressures after anaesthesia induction, we expected an effect of roughly similar magnitude would be present during elimination of nitrous oxide.||ratio||Standard Deviation|Mean
815576|NCT01093014|Primary|Skeletal Muscle Gene Expression: PPARGC1A|Messenger ribonucleic acid (mRNA) expression fold-change for peroxisome proliferator-activated receptor gamma, coactivator 1 alpha (PPARGC1A). Fold change: post-intervention expression / pre-intervention expression. Values greater than 1.0 indicate up-regulation. Values less than 1.0 indicate down-regulation.|up to 1 year|Only a subset of Arm 1 and Arm 3 participants underwent biopsy: we achieved statistical power with these subsets and further biopsies were not warranted.||fold-change||Standard Deviation|Mean
815577|NCT01093014|Primary|Skeletal Muscle Gene Regulation: MSTN|Messenger ribonucleic acid (mRNA) expression fold-change for myostatin (MSTN). Fold change: post-intervention expression / pre-intervention expression. Values greater than 1.0 indicate up-regulation. Values less than 1.0 indicate down-regulation.|up to 1 year|Only a subset of Arm 1 and Arm 3 participants underwent biopsy: we achieved statistical power with these subsets and further biopsies were not warranted.||fold-change||Standard Deviation|Mean
815578|NCT01093014|Primary|LF Muscle Force|Muscle force evoked during low-force muscle stimulation|up to 1 year|||N (newtons)||Standard Deviation|Mean
815579|NCT01093014|Primary|HF Muscle Force|Muscle force evoked during high-force muscle stimulation|up to 1 year|||Newtons (N)||Standard Deviation|Mean
815580|NCT01093027|Secondary|Tremor Rating Scale|Arm tremor severity was rated on a scale from 0=None to 4=Severe during each of four conditions: arm outstretched, hand close to mouth and arm abducted, performing a finger to nose maneuver, and holding a mug. The Tremor Rating Scale score was the mean of the scores for the four conditions, and ranged from a score of 0=None to 4=Severe.|After 10 minutes of limb cooling treatment.|||units on a scale||Standard Deviation|Mean
815581|NCT01093027|Primary|Tremor Amplitude|Average tremor amplitude during the Outstretched, Abducted, Nose, and Mug conditions of the Tremor Rating Scale test.|After 10 minutes of limb cooling treatment.|||cm/s^2||Standard Deviation|Mean
815582|NCT01093222|Secondary|Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Up to 3 years|Eligible patients who received any treatment and were assessed for toxicity were included in the adverse event summaries. Any CTCAE v4.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.||Participants|||Number
815583|NCT01093222|Secondary|Objective Response|Complete response (CR) is complete disappearance of all target and non-target lesions, no new lesions and no disease related symptoms. Partial response (PR) is a greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. Confirmed response is two or more objective statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration. Partial response is two or more objective statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration. Unconfirmed CR is one objective status of CR documented before progression or symptomatic deterioration but not qualifying as CR or PR. Unconfirmed PR is one objective status of PR documented before progression or symptomatic deterioration but not qualifying as CR, PR or unconfirmed CR.|Up to 3 years|Eligible patients who began protocol therapy||percentage of participants||95% Confidence Interval|Number
815584|NCT01093222|Primary|Progression-free Survival|From date of registration to date of first documentation of progression or symptomatic deterioration (as defined in protocol), or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact.|Up to 3 years|Eligible patients who began protocol therapy||months||95% Confidence Interval|Median
815585|NCT01093222|Secondary|Overall Survival|From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Up to 3 years|Eligible patients who began protocol therapy||months||95% Confidence Interval|Median
815586|NCT01093417|Secondary|Change in Serum 25-hydroxyvitamin D Concentration in Both Groups||Baseline and 12 weeks|||ng/mL||Inter-Quartile Range|Median
815587|NCT01093417|Primary|Change in Endothelial Function|Endothelial function measured by flow mediated brachial artery dilation|Baseline and 12 weeks|||percent change in endothelial function||Inter-Quartile Range|Median
815588|NCT01093469|Primary|Investigator Global Assessment of Improvement|This measures the overall response to treatment and quantifies disease on a 6 point scale from “completely clear” to “worsening of disease”.0= Completely clear: except for possible residual hyperpigmentation, 1= Almost clear: very significant clearance (about 90%), 2 = Marked improvement: significant improvement (about 75%), 3= Moderate improvement: intermediate between slight and marked; representing about 50% improvements , 4= Slight improvement: some improvement (about 25%); however, significant disease remaining, 5 = No change from baseline, 6 = Worse|Day 21|||units on a scale||Standard Error|Median
815589|NCT01093521|Primary|Number of Events When Study Drug Infusion Was Stopped Early|Tolerability as measured by adverse events of a 5 day continuous infusion of IV Gallium as assessed by stopping study drug infusion|6 days from starting dose|||Number of times study drug interupted|||Number
815590|NCT01093521|Primary|Number of Serious Adverse Events|Safety as measured by serous adverse events|56 days from starting dose|ITT||Serious Adverse Events|||Number
815591|NCT01093521|Secondary|Change in P. Aeruginosa Density From Baseline to Day 56|Change in sputum microbiology (specifically P. aeruginosa density based on quantitative cultures) from baseline to day 56|56 days from starting dose|All available specimens||colony counts in millions per gm sputum||Standard Deviation|Mean
815592|NCT01093521|Secondary|Change in Sputum P. Aeruginosa Density From Baseline to Day 15|Change in sputum microbiology (specifically P. aeruginosa density based on quantitative cultures) from baseline to day 15|15 days from starting dose|||colony counts in millions per gm sputum||Standard Deviation|Mean
815593|NCT01093521|Secondary|Change in P. Aeruginosa Density From Baseline to Day 8|Change in sputum microbiology (specifically P. aeruginosa density based on quantitative cultures) from baseline to day 8|8 days from starting dose|All available specimens||colony counts in millions per gm sputum||Standard Deviation|Mean
815594|NCT01093521|Secondary|Change in Spirometry as Measured by FVC From Baseline to Day 8|Change from baseline in lung function assessed by FVC in liters after treatment with IV Ga at day 8|8 days from starting dose|||liters||Standard Deviation|Mean
815595|NCT01093521|Secondary|Change in Spirometry From Baseline to Day 56|Change in lung function as measured by FEV1 in liters from baseline to day 56|56 days from starting dose|all those subjects enrolled after the amendment to add a day 56 (ITT)||liters||Standard Deviation|Mean
815596|NCT01093521|Secondary|Change in Spirometry From Baseline to Day 28|Change in lung function as measured by FEV1 in liters from baseline to day 28|28 days from starting dose|||liters||Standard Deviation|Mean
815597|NCT01093521|Secondary|Change in Lung Function From Baseline to Day 15|Change in FEV1 in liters from baseline to day 15|15 days from starting dose|||liters||Standard Deviation|Mean
815598|NCT01093521|Secondary|Change in Spirometry From Baseline to Day 8|Change in spirometry as measured by FEV1 in liters from baseline to day 8|8 days|ITT||liters||Standard Deviation|Mean
815599|NCT01093521|Primary|Pharmacokinetic Assessment of a 5 Day Infusion of Gallium Nitrate (IV Ganite®)|"To assess the summed area under the curves of a 5 day infusion of IV Ga from day 1 to day 28 at two doses: 100 mg/m2/day in adult subjects with CF; 200 mg/m2/day in adult subjects with CF.
To assess the safety of a 5 day infusion of IV Ga at two doses: 100 mg/m2/day in adult subjects with CF; 200 mg/m2/day in adult subjects with CF.
Safety and tolerability of 5 days of treatment with IV administered gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day and 200 mg/m2/day."|Day 1 at t=1, 2 and 6 hours, Day 3, Day 6 at t= 1, 2, 8, and 12, Day 14 and Day 28|||ug*hr/mL||Standard Deviation|Mean
815651|NCT01094119|Primary|Time Weighted Average Core Temperature|Time weighted average core temperature (esophogeal temperature) from tracheal intubation to 3 hours after or tracheal extubation|from tracheal intubation to 3 hours after or tracheal extubation|Randomized patients.||Degrees C||Standard Deviation|Mean
815625|NCT01093599|Secondary|Changes in Self Reported Measures of Depression, Anxiety and Stress in Study Subjects vs Controls||6 months post quit day||||||
815626|NCT01093599|Primary|Smoking Abstinence|Smoking abstinence is measured by Carbon Monoxide Breath Testing in Controls vs Study Group subjects six months after the quit day.|6 months post quit day|intent to treat analysis||participants|||Number
815627|NCT01093625|Secondary|Comfortable Wearing Time|Average numbers of overall average daily contact lens wear hours and average daily comfortable wear hours as reported at each follow-up visit.|1 Year|Subjects analyzed were those who were enrolled, randomized to the test group, and completed the study.||Hours||95% Confidence Interval|Least Squares Mean
815628|NCT01093625|Primary|Differences in Subjective Comfort From the Contact Lens User Experience (CLUE) Questionnaire|The subjective comfort questionnaire CLUE, assesses the overall lens comfort. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response, with a range of 0-120. The differences between: (final visit and first visit) and then (final visit and 6 months) are reported.|1 Year|Subjects analyzed were those who were enrolled, randomized to the test group, and completed the study.||units on a scale||95% Confidence Interval|Least Squares Mean
815629|NCT01093625|Primary|Corneal Neovascularization|New vascularization of the Cornea. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score.|1 Year|Subjects analyzed were those who were enrolled, randomized to the study groups, and completed the study.||units on a scale||95% Confidence Interval|Least Squares Mean
815630|NCT01093625|Primary|Conjunctival Staining|Mild abrasions of the conjunctival area of the eye. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score.|1 Year|Subjects analyzed were those who were enrolled, randomized to the study groups, and completed the study.||units on a scale||95% Confidence Interval|Least Squares Mean
815631|NCT01093625|Primary|Corneal Staining|Abrasions in the cornea area of the eye using a slit lamp. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments.|1 Year|Subjects analyzed were those who were enrolled, randomized to the study groups, and completed the study.||Efron Scale (0.1 Unit increments)||95% Confidence Interval|Least Squares Mean
815632|NCT01093625|Primary|Limbal Hyperemia|Swelling of the vessels in the limbal area of the eye using a slit lamp. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score.|1 Year|Subjects analyzed were those who were enrolled, randomized to the study groups, and completed the study.||units on a scale||95% Confidence Interval|Least Squares Mean
815633|NCT01093625|Primary|Conjunctival Hyperemia|Comparison of the amount of redness in the conjunctival area of the eye, between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score.|1 Year|Subjects analyzed were those who were enrolled, randomized to the study groups, and completed the study.||units on a scale||95% Confidence Interval|Least Squares Mean
815634|NCT01093625|Primary|Papillary Conjunctivitis|Swelling of the papillary (Papillary conjunctivitis) area of the eye was assessed using a slit-lamp. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score.|1 Year|Subjects analyzed were those who were enrolled, randomized to the study groups, and completed the study.||units on a scale||95% Confidence Interval|Least Squares Mean
815635|NCT01093651|Secondary|Self-reported Symptoms|Cumulative number of self-reported symptoms based on the Division of AIDS Grading Scale for the Severity of Adult Adverse Events (0-4 scale where 0 is no new symptoms, 4 is serious adverse event or toxicity)|Monthly for 4 months|Cumulative frequency over 16 weeks of any self-reported symptoms on the DAIDS scale||total number of self reported symptoms|||Number
815636|NCT01093651|Secondary|Oral Glucose Tolerance|Area under the 75-gr oral glucose tolerance curve (AUCg) based on plasma glucose values measured at 0, 30, 60, 90, and 120 mins post-glucose challenge.|Baseline, week 8, week 16|||mg*min/mL||Standard Deviation|Mean
815637|NCT01093651|Secondary|RANTES; Serum Biomarkers of Immune Activation|serum Regulated on Activation, Normal T cell Expressed and Secreted concentration|Baseline, week 8, week 16|RANTES||ng/mL||Standard Deviation|Mean
815638|NCT01093651|Secondary|SDF1α; Serum Biomarkers of Immune Activation|serum stromal cell-derived factor-1α concentration|Baseline, week 8, week 16|SDF1α||pg/mL||Standard Deviation|Mean
815639|NCT01093651|Secondary|Soluble TNFR2; Serum Biomarkers of Immune Activation|serum soluble tumor necrosis factor receptor-2 concentration|Baseline, week 8, week 16|sTNFR2||pg/mL||Standard Deviation|Mean
815640|NCT01093651|Primary|Plasma HIV Viremia (Viral Load)|Percentage of participants with plasma HIV RNA copy number less than 48 copies/mL|Monthly for 6 months|||percentage of participants below 48 c/mL|||Number
815641|NCT01093651|Primary|CD4+ T-cell Count||Monthly for 4 months|CD4+ T-cell count||cells/µL||Standard Deviation|Mean
815642|NCT01093690|Secondary|Toxicities and Severity of Nausea and Vomiting||5 days after receiving chemotherapy||||||
815643|NCT01093690|Primary|Number of Patients Who Had Complete Response|number of patients who experience no emesis and need no rescue treatment in 5-day period|5 days after receiving chemotherapy|intention to treat||participants|||Number
815644|NCT01093755|Primary|Change in Esophageal Inflammation Biomarker COX-2 Gene Expression|Change from baseline in esophageal issue biopsy cyclooxygenase-2 (COX-2) gene expression, as determined by Western blot.|3 months, 6 months|||% of tubulin||Standard Deviation|Mean
815645|NCT01093755|Primary|Change in Inflammation Biomarker Tissue PGE2 Level|Change from baseline in esophageal tissue biopsy prostaglandin E2 (PGE2) level, as determined by enzyme immunoassay|3 months, 6 months|||nanograms/gram of tissue||Standard Deviation|Mean
815646|NCT01093794|Primary|Cmax for Sitagliptin and Metformin|Cmax is the peak serum concentration of a therapeutic drug after administration; and is used to determine the rate and extent of drug absorption. Cmax is reported for sitagliptin 50 mg, metformin 500 mg and metformin 850 mg.|baseline through 72 hours postdose|Per-Protocol (PP) set: Participants who completed the study according to the protocol. One participant who discontinued after Treatment Period 1 was not included in the analysis.||ng/mL||Standard Deviation|Mean
815647|NCT01093794|Primary|Area Under the Curve (AUC(0-t)) for Sitagliptin|AUC (0-t) is the area under the curve for the plot showing plasma concentration against time from time zero to the time of the last quantifiable concentration for sitagliptin 50 mg, metformin 500 mg and metformin 850 mg.|baseline through 72 hours postdose|Per-Protocol (PP) set: Participants who completed the study according to the protocol. One participant who discontinued after Treatment Period 1 was not included in the analysis.||hr*ng/mL||Standard Deviation|Mean
815648|NCT01093846|Primary|The Effect of Continuous Treatment With Subcutaneous AIN457 Compared to Placebo in Reducing the Rate of Recurrent Ocular Exacerbations in Behçet’s Patients With Intermediate Uveitis, Posterior Uveitis or Panuveitis in Group 1.|The primary objective of the study was to determine the effect of continuous treatment with subcutaneous AIN457 compared to placebo in reducing the rate of recurrent ocular exacerbations in Behçet’s patients with intermediate uveitis, posterior uveitis or panuveitis in patients who completed the core study and continued treatment in the extension study (Group 1).Due to early termination of the study AIN457C2303E1, the analysis of extension period was changed. No efficacy analyses were completed, the safety analyses are available in the summary of AEs which occurred during the extension and safety follow-up periods and are shown in the safety section .|62 weeks||||||
815649|NCT01093976|Primary|Massachusetts General Hospital Hairpulling Scale (MGH-HPS) Total Score|The MGH-HPS is a 7-item, self-report scale that rates urges to pull hair, actual amount of pulling, perceived control over behavior, and distress associated with hair pulling over the past seven days. Total possible score is a 28 indicating the highest level of severity out of a scale from 0-28.|Subjects were followed for their duration of participation in the study (12-weeks)|Mean score reported below is the endpoint MGH-HPS score (at 12-weeks or last-observation carried forward).||units on a scale||Standard Deviation|Mean
815650|NCT01094119|Secondary|Proportion of Patients With Temperatures Above 36 Degree|Proportion of patients with esophogeal temperatures above 36 degree at the end of surgery|at the end of surgery|Enrolled patients||Participants|||Count of Participants
815652|NCT01094171|Primary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs).|SAEs assessed included medical occurrences that resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|During the entire study period (Day 0 – Month 4)|||Subjects|||Number
815653|NCT01094171|Primary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 31-day (Days 0 - 30) post vaccination period|||Subjects|||Number
815654|NCT01094171|Primary|Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms|Solicited general symptoms assessed were Drowsiness, Irritability, Loss of appetite and Fever [Axillary temperature greater than or equal to (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any specified solicited general symptoms reported irrespective of intensity grade or relationship to vaccination. Any fever = oral temperature ≥ 37.5 degrees Celsius (°C). Grade 3 symptoms = symptoms that prevented normal activities. Grade 3 fever = oral temperature > 39.0°C.|During the 4-day (Days 0 - 3) post vaccination period|||Subjects|||Number
815655|NCT01094171|Primary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any specified solicited local symptoms reported irrespective of intensity grade. Grade 3 pain was defined as considerable pain that prevented normal everyday activities. Grade 3 redness and swelling were defined as redness and swelling greater than (>) 20 millimeters (mm)|During the 4-day (Days 0 - 3) post vaccination period|||Subjects|||Number
815656|NCT01094522|Primary|Maximum Concentration of Methadone Including Its Metabolites (EDDP and EMDP)||0, 15, 30 minutes, 1, 2, 4, 6 hrs, every 6 hrs up to 24 hrs|||ng/mL||Full Range|Median
815657|NCT01094522|Secondary|•Amount of Study Drug Administered During the 24-hour Dosing Period||24 hours|||mg||Full Range|Mean
815658|NCT01094522|Secondary|•Pain Scores (FLACC) During the 24 Hours Study Period|"Average of hourly FLACC score for each subject over 24 hours was calculated, followed by median and full range for total subjects in each arm.
FLACC (Face, Leg, Activity, Cry, Consolability) score ranges from 0-10 with 0 representing no pain"|24 hours|Hourly FLACC score was calculated for 16 subjects in Methadone group and 19 subjects in morphine group||units on a scale||Full Range|Median
815659|NCT01094522|Primary|Maximum Concentration of Morphine Including Its Metabolites (Morphine-3-glucuronide and Morphine-6-glucuronide)||0, 15, 30 minutes, 1, 2, 4, 6 hrs, every 6 hrs up to 24 hrs|||ng/mL||Full Range|Median
815660|NCT01094548|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs),Serious TEAEs, TEAEs of Grade 3 or 4 According to NCI-CTCAE v3.0, TEAEs Leading to Discontinuation and Injection Site Reactions (ISRs)|TEAEs occurred between the first dose of study drug administration and up to 42 days after the last dose of study drug administration that were absent before treatment or that worsened relative to pretreatment state. A Serious TEAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.Grade 3 and 4 TEAES as per National Cancer Institute Common Terminology Criteria for Adverse Experience version 3 (NCI-CTCAE v3.0) were presented. Grade 3 refers to severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care and Activity of daily living (ADL).Grade 4 refers to Life-threatening consequences; where urgent intervention indicated. Injection site reactions, term used per NCI-CTCAE, were also presented.|From the first dose of study drug administration up to 42 days after the last dose of study drug administration or clinical data cut-off date (07 March 2012)|Safety analysis set included all the randomized participants who received at least 1 dose of trial treatment.||participants|||Number
815661|NCT01094548|Secondary|Time to Anti-tumor Therapy|Time from date of randomization to the date of first anti-tumor therapy since end of study treatment. In case a concomitant or concurrent procedure was identified as anti-tumor therapy during the medical review process, the start date of that anti-tumor therapy was used instead. Participants in the survival follow-up phase without subsequent anti-tumor therapy at the time of the analysis were censored at the latest available follow-up date. Participants without anti-tumor therapy and still on treatment at the time of analysis were censored at the data cut-off date if any trial treatment administration was recorded after the data cut-off date. In case no such record exists, the subject was censored at the last available administration date prior or equal to the data cut-off date. Participants dying before start of subsequent anti-tumor therapy were treated as censored observations at time of death.|From the date of randomization up to Month 48|Immunological diagnostic analysis set was defined as the subset of safety analysis set consisting of all the participants with at least one complete set of baseline (baseline/cyclophosphamide infusion visit or both), Week 5, and Week 9 data of either ELISPOT, proliferation assay or cytokine assay.||months||95% Confidence Interval|Median
815662|NCT01094548|Secondary|Time to Progression (TTP)|Progression was defined as follows per Blade criteria: The disease was considered to be progressive if it met 1 or more of the following: >25% increase in the level of serum monoclonal paraprotein (M-protein);>25% increase in the 24 h urinary light chain excretion; >25% increase in plasma cells in the bone marrow- definite increase in the size of existing bone lesions or soft tissues plasmacytomas (STP); Development of new bone lesions or STP, or development of hypercalcemia. TTP was defined as time from randomization to disease progression. Participants without events were censored on the date of last tumor assessment. Participants without PD at time of treatment discontinuation were censored at the date of discontinuation. Participants without PD at the time of the analysis but still on treatment were censored at the date of the latest available multiple myeloma status assessment. Participants dying from causes other than PD were treated as censored observations at time of death.|From the date of randomization up to Month 48|Immunological diagnostic analysis set was defined as the subset of safety analysis set consisting of all the participants with at least one complete set of baseline (baseline/cyclophosphamide infusion visit or both), Week 5, and Week 9 data of either ELISPOT, proliferation assay or cytokine assay.||months||95% Confidence Interval|Median
815663|NCT01094548|Secondary|Percentage of Participants With Objective Clinical Response (Complete Response [CR], or Partial Response [PR], or Minimal Response [MR]|OCR (CR, or PR, or MR or NC or PD or NE) was defined per Blade Criteria. OCR rate (CR, or PR, or MR) was defined as the number of participants having experienced at least once a CR, PR, or MR, divided by the number of all participants. CR: negative immunofixation on serum and urine monoclonal paraprotein (M-protein), disappearance of any soft tissue plasmacytomas (STP), <=5% plasma cells in bone marrow (BM); PR: >=50% reduction in serum M-protein, plasma cells in BM, size of STP; >=90% reduction of urinary M-protein in 24 hours, no increase in size/number of the lytic bone lesions (LBL). MR: 25%-49% reduction in serum M-protein, plasma cells in BM aspirate in non-secretory myeloma participants, size of STP; 50%-89% reduction in 24 h urinary light chain reaction (LCR), and no increase in size/number of LBL. PD: >25% increase in the serum M-protein level, 24 hour urinary LCR. Increase in size of existing BL or STP, development of new BL or STP, or development of hypercalcemia|From the date of randomization up to Month 48|Immunological diagnostic analysis set was defined as the subset of safety analysis set consisting of all the participants with at least one complete set of baseline (baseline/cyclophosphamide infusion visit or both), Week 5, and Week 9 data of either ELISPOT, proliferation assay or cytokine assay.||Percentage of participants|||Number
815664|NCT01094548|Secondary|Number of Participants With Overall Induced Immune Response by Human Leukocyte-associated Antigen (HLA) Type|Relationship between immune response with HLA subtypes was determined by analyzing the number of participants with overall induced immune response grouped by the presence versus absence of the given HLA type.|From the date of randomization up to Week 104|Immunological diagnostic analysis set was defined as the subset of safety analysis set consisting of all the participants with at least 1 complete set of baseline, Week 5, and Week 9 data of either ELISPOT, proliferation assay or cytokine assay. “n” signifies number of participants evaluable for the particular HLA type, respectively.||participants|||Number
815665|NCT01094548|Secondary|Number of Participants With Baseline Immune Response and Initial Increase of MUC1 Specific Immune Response|Baseline immune response towards MUC1 was defined as an immune response towards BP25, MUC-A2 or MUC-A11 peptide stimulation which was present in at least one of the two baseline assessments; the specific immune responses at baseline were based on the averaged baseline values across the two baseline visits. Initial increase of MUC1-specific immune response was defined as an increase of MUC1-specific immune response during the primary treatment period (up to Week 9).|Baseline and Week 9|Immunological diagnostic analysis set was defined as the subset of safety analysis set consisting of all the participants with at least one complete set of baseline (baseline/cyclophosphamide infusion visit or both), Week 5, and Week 9 data of either ELISPOT, proliferation assay or cytokine assay.||participants|||Number
815666|NCT01094548|Primary|Number of Participants With Overall Induced Mucinous Glycoprotein-1 (MUC-1)-Specific Immune Response|The overall immune response was achieved at least for 2 timepoints; that is at least 1 parameter in at least 1 assay (Lymphoproliferation assay, enzyme-linked immunospot (ELISPOT) for interferon [IFN] gamma, and intracellular IFN gamma cytokine assay in peripheral blood mononuclear cell [PBMC]) with ratio to background >=2, and ratio of background-corrected value to baseline >=2;Specific immune response at a given timepoint 't' was considered as differences of log-scale values under stimulation (X vax,t ) to those of the respective unstimulated controls (Xneg,t, background values)were computed after certain assay-specific pre-processing steps: Yt = Xvax,t – Xneg,t; A participant was considered to show positive stimulation-induced immune response at timepoint 't' (POS[t]=1), upon fulfilling the following criteria: Yt =>1 (That is at least a 2-fold higher value under stimulation than without stimulation). AVvax,t–1SEM vax,t > AVneg,t+1SEMneg,t (ELISPOT and proliferation assay only).|From the date of randomization up to Week 104|Immunological diagnostic analysis set was defined as the subset of safety analysis set consisting of all the participants with at least one complete set of baseline (baseline/cyclophosphamide infusion visit or both), Week 5, and Week 9 data of either ELISPOT, proliferation assay or cytokine assay.||participants|||Number
815667|NCT01094561|Secondary|The Positive Predictive Value of S-MRCP|"The secondary outcome endpoints of our study will be positive predictive value of S-MRCP, in comparison with EUS/S-EUS and endoscopic retrograde cholangiopancreatography (ERCP), utilizing surgical pathology as the gold standard. In addition, we will also be looking at the utility of Cancer Antigen 19-9 (CA 19-9) and oral glucose tolerance tests.
Due to poor enrollment, inadequate data was collected for data analysis and therefore data analysis was not conducted. There is no data to report."|Up to 1 year||||||
815668|NCT01094561|Primary|S-MRCP and S-EUS Concordance|"The primary outcome studied will be the concordance of S-MRCP and S-EUS. Screening will consist of two diagnostic imaging modalities. First, all patients will have S-MRCP in conjunction with contrast-enhanced magnetic resonance imaging (MRI)/magnetic resonance angiography (MRA). All images will be analyzed by a radiologist. Within thirty days, all patients will also undergo EUS with and without secretin enhancement (S-EUS).If the S-EUS shows abnormalities, EUS-guided fine-needle aspiration will be performed. The S-MRCP and EUS image findings will be classified as benign or suspicious/malignant to determine the concordance between imaging techniques.
Due to poor enrollment, inadequate data was collected for data analysis and therefore data analysis was not conducted. There is no data to report."|Day 1 and up to 30 days after S-MRCP||||||
815669|NCT01094574|Secondary|Change in Arbitrary Perfusion Units From Baseline During Drug Infusion|Laser Doppler images were recorded at baseline and at 2 and 3 hours after starting the drug infusion to provide measurements of peripheral blood flow as an objective measure of inflammation. Blood flow was quantified by arbitrary perfusion units. Baseline measurements were subtracted from the average measurements obtained 2 and 3 hours after starting the drug infusion.|Laser doppler images were recorded at baseline and at 2 and 3 hours after starting the drug infusion|||relative flux||Standard Deviation|Mean
815670|NCT01094574|Secondary|IL-12 (ng/mL) Change From Baseline During Infusion|IL-12 (ng/mL) was measured in interstitial fluid after collecting samples as follows: Microdialysis catheters (very small, custom-made, sterile, semi-permeable, micro-dialysis catheters) were placed after the 1st laser Doppler measurement. Two catheters were placed at an experimentally inflamed skin site on the left leg. A continuous infusion of sterile 1% albumin solution was started using a programmable pump set at a rate of 2.5µl/min. Samples were collected hourly throughout the remainder of the study day. Samples for analysis were collected before, and 2 and 3 hours after starting the drug infusion. Difference form baseline was calculated by subtracting the baseline concentration form the average concentration determined in samples collected during drug infusion.|Tissue samples were collected at baseline, and 2 and 3 hours after starting the drug infusion.|||ng/ml||Standard Deviation|Mean
815671|NCT01094574|Secondary|IL-10 (ng/mL) Change From Baseline During Infusion|IL-10 (ng/mL) was measured in interstitial fluid after collecting samples as follows: Microdialysis catheters (very small, custom-made, sterile, semi-permeable, micro-dialysis catheters) were placed after the 1st laser Doppler measurement. Two catheters were placed at an experimentally inflamed skin site on the left leg. A continuous infusion of sterile 1% albumin solution was started using a programmable pump set at a rate of 2.5µl/min. Samples were collected hourly throughout the remainder of the study day. Samples for analysis were collected before, and 2 and 3 hours after starting the drug infusion. Difference form baseline was calculated by subtracting the baseline concentration form the average concentration determined in samples collected during drug infusion.|Tissue samples were collected at baseline, and 2 and 3 hours after starting the drug infusion.|||ng/ml||Standard Deviation|Mean
815672|NCT01094574|Secondary|IL-8 (ng/mL) Change From Baseline During Infusion|IL-8 (ng/mL) was measured in interstitial fluid after collecting samples as follows: Microdialysis catheters (very small, custom-made, sterile, semi-permeable, micro-dialysis catheters) were placed after the 1st laser Doppler measurement. Two catheters were placed at an experimentally inflamed skin site on the left leg. A continuous infusion of sterile 1% albumin solution was started using a programmable pump set at a rate of 2.5µl/min. Samples were collected hourly throughout the remainder of the study day. Samples for analysis were collected before, and 2 and 3 hours after starting the drug infusion. Difference form baseline was calculated by subtracting the baseline concentration form the average concentration determined in samples collected during drug infusion.|Tissue samples were collected at baseline, and 2 and 3 hours after starting the drug infusion.|||ng/ml||Standard Deviation|Mean
815673|NCT01094574|Secondary|GMCSF (ng/mL) Change From Baseline During Infusion|GMCSF (ng/mL) was measured in interstitial fluid after collecting samples as follows: Microdialysis catheters (very small, custom-made, sterile, semi-permeable, micro-dialysis catheters) were placed after the 1st laser Doppler measurement. Two catheters were placed at an experimentally inflamed skin site on the left leg. A continuous infusion of sterile 1% albumin solution was started using a programmable pump set at a rate of 2.5µl/min. Samples were collected hourly throughout the remainder of the study day. Samples for analysis were collected before, and 2 and 3 hours after starting the drug infusion. Difference form baseline was calculated by subtracting the baseline concentration form the average concentration determined in samples collected during drug infusion.|Tissue samples were collected at baseline, and 2 and 3 hours after starting the drug infusion.|||ng/ml||Standard Deviation|Mean
815674|NCT01094574|Secondary|IL-6 (ng/mL) Change From Baseline During Infusion|IL-6 (ng/mL) was measured in interstitial fluid after collecting samples as follows: Microdialysis catheters (very small, custom-made, sterile, semi-permeable, micro-dialysis catheters) were placed after the 1st laser Doppler measurement. Two catheters were placed at an experimentally inflamed skin site on the left leg. A continuous infusion of sterile 1% albumin solution was started using a programmable pump set at a rate of 2.5µl/min. Samples were collected hourly throughout the remainder of the study day. Samples for analysis were collected before, and 2 and 3 hours after starting the drug infusion. Difference form baseline was calculated by subtracting the baseline concentration form the average concentration determined in samples collected during drug infusion.|Tissue samples were collected at baseline, and 2 and 3 hours after starting the drug infusion.|||ng/ml||Standard Deviation|Mean
815675|NCT01094574|Secondary|IL-2 (ng/mL) Change From Baseline During Infusion|IL-2 (ng/mL) was measured in interstitial fluid after collecting samples as follows: Microdialysis catheters (very small, custom-made, sterile, semi-permeable, micro-dialysis catheters) were placed after the 1st laser Doppler measurement. Two catheters were placed at an experimentally inflamed skin site on the left leg. A continuous infusion of sterile 1% albumin solution was started using a programmable pump set at a rate of 2.5µl/min. Samples were collected hourly throughout the remainder of the study day. Samples for analysis were collected before, and 2 and 3 hours after starting the drug infusion. Difference form baseline was calculated by subtracting the baseline concentration form the average concentration determined in samples collected during drug infusion.|Tissue samples were collected at baseline, and 2 and 3 hours after starting the drug infusion.|||ng/ml||Standard Deviation|Mean
815676|NCT01094574|Secondary|IL-1β (ng/mL) Change From Baseline During Infusion|IL-1β (ng/mL) was measured in interstitial fluid after collecting samples as follows: Microdialysis catheters (very small, custom-made, sterile, semi-permeable, micro-dialysis catheters) were placed after the 1st laser Doppler measurement. Two catheters were placed at an experimentally inflamed skin site on the left leg. A continuous infusion of sterile 1% albumin solution was started using a programmable pump set at a rate of 2.5µl/min. Samples were collected hourly throughout the remainder of the study day. Samples for analysis were collected before, and 2 and 3 hours after starting the drug infusion. Difference form baseline was calculated by subtracting the baseline concentration form the average concentration determined in samples collected during drug infusion.|Tissue samples were collected at baseline, and 2 and 3 hours after starting the drug infusion.|||ng/ml||Standard Deviation|Mean
815677|NCT01094574|Secondary|TNFα (ng/mL) Change From Baseline During Infusion|TNFα (ng/mL) was measured in interstitial fluid after collecting samples as follows: Microdialysis catheters (very small, custom-made, sterile, semi-permeable, micro-dialysis catheters) were placed after the 1st laser Doppler measurement. Two catheters were placed at an experimentally inflamed skin site on the left leg. A continuous infusion of sterile 1% albumin solution was started using a programmable pump set at a rate of 2.5µl/min. Samples were collected hourly throughout the remainder of the study day. Samples for analysis were collected before, and 2 and 3 hours after starting the drug infusion. Difference form baseline was calculated by subtracting the baseline concentration form the average concentration determined in samples collected during drug infusion.|Tissue samples were collected at baseline, and 2 and 3 hours after starting the drug infusion.|||ng/ml||Standard Deviation|Mean
815678|NCT01094574|Primary|Change From Baseline in Mechanical Pain Threshold During Infusion in Inflamed Skin|A metal rod of 0.24 mm diameter mounted onto 10 different weights (1.0, 2.0, 4.1, 8.2,16.3, 20, 32.7,49.0, 65.3, and 81.3g) will be placed perpendicularly onto the skin. Starting with the lightest probe, consecutively heavier probes will be used until a subject reports pain. Subsequently, the same or the next lighter probe will be used if pain is reported for the preceding stimulus, or the same or the next heavier probe will be used if no pain is reported for the preceding stimulus.The procedure will be repeated until seven perceptional changes (painful/non-painful) are registered. Measurements for anti-hyperalgesia were taken at the sites of tissue injury. Change form baseline was calculated by subtracting baseline values from the average values obtained 1 and 2 hours after starting the drug infusion.|Participants underwent the pain testing measures at baseline and at 1 and 2 hours after startingthe drug infusion.|||weight in grams||Standard Deviation|Mean
815679|NCT01094574|Primary|Change From Baseline in Mechanical Pain Threshold During Infusion in Non-Inflamed Skin|A metal rod of 0.24 mm diameter mounted onto 10 different weights (1.0, 2.0, 4.1, 8.2,16.3, 20, 32.7,49.0, 65.3, and 81.3g) will be placed perpendicularly onto the skin. Starting with the lightest probe, consecutively heavier probes will be used until a subject reports pain. Subsequently, the same or the next lighter probe will be used if pain is reported for the preceding stimulus, or the same or the next heavier probe will be used if no pain is reported for the preceding stimulus.The procedure will be repeated until seven perceptional changes (painful/non-painful) are registered. Measurements for analgesia were taken at the sites of non-injured skin. Change form baseline was calculated by subtracting baseline values from the average values obtained 1 and 2 hours after starting the drug infusion.|Participants underwent the pain testing measures at baseline and at 1 and 2 hours after startingthe drug infusion.|||weight in grams||Standard Deviation|Mean
815680|NCT01094574|Primary|Change From Baseline in Heat Pain Threshold During Infusion in Inflamed Skin|Degrees Centigrade Heat pain was induced with a thermal sensory analyzer (TSA-II, Medoc Advanced Medical Systems, Durham, North Carolina). A thermode was placed in contact with skin on the upper thigh. Starting at a comfortable temperature, the thermode temperature was increased at a measured rate. Study participants pushed a button of a hand-held device at the onset of pain at which point the thermode immediately reduced the temperature. Measurements for anti-hyperalgesia were taken at the sites of tissue injury. Change form baseline was calculated by subtracting baseline values from the average values obtained 1 and 2 hours after starting the drug infusion.|Participants underwent the pain testing measures at baseline and at 1 and 2 hours after startingthe drug infusion.|||degrees centigrade||Standard Deviation|Mean
815681|NCT01094574|Primary|Change From Baseline in Heat Pain Threshold During Infusion in Non-Inflamed Skin|Degrees Centigrade Heat pain was induced with a thermal sensory analyzer (TSA-II, Medoc Advanced Medical Systems, Durham, North Carolina). A thermode was placed in contact with skin on the upper thigh. Starting at a comfortable temperature, the thermode temperature was increased at a measured rate. Study participants pushed a button of a hand-held device at the onset of pain at which point the thermode immediately reduced the temperature. Measurements for analgesia were taken at the sites of non-injured skin. Change form baseline was calculated by subtracting baseline values from the average values obtained 1 and 2 hours after starting the drug infusion.|Participants underwent the pain testing measures at baseline and at 1 and 2 hours after startingthe drug infusion.|||degree centigrade||Standard Deviation|Mean
815682|NCT01094704|Primary|Change in Average Mucociliary Clearance (0-90 Minutes) at 1 and 4 Hrs Post Dose (MCC4hr - MCCbaseline; MCC1hr - MCCbaseline)|Duration of action of hypertonic saline as determined by measurements of mucociliary clearance/cough clearance 4 hours post dose.|1-4 hours post-dose|ITT||Absolute % change||Standard Deviation|Mean
815683|NCT01094730|Secondary|Subject Reported Overall Lens Comfort at Day 14|The overall lens comfort was assessed at Day 14 using the CLUE questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging)in a contact lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable /positive response. 97% of the scores fall within 0 and 120 (mean +/-3*SD).|Evaluated at Day 14|Analysis was conducted on subjects who successfully completed the study.||CLUE points||Standard Error|Mean
815684|NCT01094730|Primary|Lens Front Surface Deposits at Day 14|Deposits on the front surface of each lens were examined by the investigator after 14 days of lens wear, and graded on a 5-point scale; 0 = 0% deposits, 1 = 1%-5% deposits, 2 = 6%-15% deposits, 3=16%-25% deposits, and 4= 25% or more deposits. The grades were categorized into binary variable: grade 0 or 1 vs. grade 2 or higher.|Evaluated at Day 14|Analysis was conducted on subjects who successfully completed the study.||dichtomized grading scale|Contact Lenses|Standard Deviation|Mean
815685|NCT01094730|Secondary|Subject Reported Overall Lens Comfort at Day 7|The overall lens comfort was assessed at Day 7 using the Contact Lens User Experience (CLUE) questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging)in a contact lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable /positive response. 97% of the scores fall within 0 and 120 (mean +/-3*SD).|Evaluated at Day 7|Analysis was conducted on subjects who successfully completed the study.||CLUE points||Standard Error|Mean
815686|NCT01094730|Primary|Lens Front Surface Deposits at Day 7|Deposits on the front surface of each lens were examined by the investigator after 7 days of lens wear, and graded on a 5-point scale; 0 = no deposit, 1 = 1%-5% deposits, 2 = 6%-15% deposits, 3 = 16%-25% deposits, and 4 = 25% or more deposits. The grades were categorized into binary variable: grade 0 or 1 Vs. grade 2 or higher.|Evaluated at Day 7|Analysis was conducted on subjects who successfully completed the study.||dichotomized grading scale|eyes|Standard Deviation|Mean
832414|NCT01255423|Secondary|Pain on Movement|"Pain on movement at 24 hours and 7 days assessed on a 100 mm visual analog scale with anchors at 0= No pain and 100= Extreme pain"|24 hours and 7 days|||mm||Standard Deviation|Mean
815694|NCT01094808|Secondary|Pain Sensation Rating Averaged Across 4 Distension Pressures (16, 24, 30, and 36 mg Hg)|The mm Hg distensions refer to the barostat balloon, which was placed in the mid-descending or junction of the sigmoid and descending colon. Pain sensation was measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes. For the pain VAS, 0 means no pain and 100 mm means extreme pain. The investigator measures the mark made by the participant in mm and records this for the value of pain. The values across the 4 distension pressures were averaged for this outcome measure.|Approximately 60 minutes after drug administration|||mm||Standard Deviation|Mean
815695|NCT01094808|Secondary|Gas Sensation Rating Averaged Across 4 Distension Pressures (16, 24, 30, and 36 mg Hg)|The mm Hg distensions refer to the barostat balloon, which was placed in the mid-descending or junction of the sigmoid and descending colon. Gas sensation was measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes. For the gas VAS, 0 means no gas sensation and 100 mm means extreme gas sensation. The investigator measures the mark made by the participant in mm and records this for the value of gas. The values across the 4 distension pressures were averaged for this outcome measure.|Approximately 60 minutes after drug administration|||mm||Standard Deviation|Mean
815696|NCT01094808|Secondary|Sensation Ratings for Gas at 16, 24, and 36 mm Hg Distension|The mm Hg distensions refer to the barostat balloon, which was placed in the mid-descending or junction of the sigmoid and descending colon. Gas sensation was measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes. For the gas VAS, 0 means no gas sensation and 100 mm means extreme gas sensation. The investigator measures the mark made by the participant in mm and records this for the value of either pain or gas.|Approximately 60 minutes after drug administration|||mm||Standard Deviation|Mean
815697|NCT01094808|Secondary|Sensation Ratings for Pain at 16, 24, and 36 mm Hg Distension|The mm Hg distensions refer to the barostat balloon, which was placed in the mid-descending or junction of the sigmoid and descending colon. Pain sensation was measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes. For the pain VAS, 0 means no pain and 100 mm means extreme pain. The investigator measures the mark made by the participant in mm and records this for the value of pain.|Approximately 60 minutes after drug administration|||mm||Standard Deviation|Mean
815698|NCT01094808|Secondary|Sensory Threshold for Gas|The sensory threshold for first perception of gas was measured by stepwise inflation of the balloon in increments of 4 mm Hg at 60 second intervals. (The balloon was placed in the mid-descending or junction of the sigmoid and descending colon.) During this assessment participants were asked to report when they had the first perception of gas. The investigator recorded the threshold pressure at which the participants reported this sensation.|Approximately 60 minutes after drug administration|||mm Hg||Standard Deviation|Mean
815699|NCT01094808|Primary|Postprandial Motility Index Over 30 Minutes|The first 30 minute postprandial motility index (MI), MI = log_e [(number of contractions * sum of amplitudes)+1]|30 minutes after the meal|||log mm Hg||Standard Deviation|Mean
815700|NCT01094808|Primary|Postprandial Colonic Tone [Reported] as the Symmetric Percent [Change]in Baseline Colonic Barostat Balloon Volume|The symmetric percent reduction in baseline colonic barostat balloon volume during the first 30 minutes postprandially (PP) corrected for the preprandial (30 min) tone, (symmetric percent change= 100*log_e[fasting/PP]). A positive symmetric percent change reflects a decrease in barostat balloon volume indicating a reduction in colonic tone. (The balloon was placed in the mid-descending or junction of the sigmoid and descending colon.)|The first 30 minutes postprandially, and preprandial (30 minutes)|||Symmetric percentage change||Standard Deviation|Mean
815701|NCT01094808|Primary|Colonic Compliance|"Colonic compliance is a measure of the stiffness of the colon, that is, what pressure was needed to reach half the maximum value of the colon. After the barostat balloon catheter was inserted in the mid-descending or junction of the sigmoid and descending colon, the balloon was inflated. After an initial conditioning distension to 20 mm Hg, colonic compliance was measured by step-wise inflation with increments of 4 mm Hg. Colonic compliance was analyzed by a validated linear interpolation method. The pressure at half maximum volume serves as a summary of colonic compliance."|Approximately 60 minutes after drug administration|||mm Hg||Standard Deviation|Mean
815702|NCT01094808|Primary|Sensation Ratings for Pain and Gas at 30 mm Hg Distension Above Baseline Operating Pressure|The 30 mm Hg distension refers to inflation of the balloon placed in placed in the mid-descending or junction of the sigmoid and descending colon. Pain and gas were individually measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes. For the pain VAS, 0 means no pain and 100 mm means extreme pain. For the gas VAS, 0 means no gas sensation and 100 mm means extreme gas sensation. The investigator measures the mark made by the participant in mm and records this for the value of either pain or gas.|Approximately 60 minutes after drug administration|||mm||Standard Deviation|Mean
815703|NCT01094808|Primary|Sensory Threshold for Pain|The sensory threshold for first perception of pain was measured by stepwise inflation of the balloon in increments of 4 mm Hg at 60 second intervals. The balloon was placed in the mid-descending or junction of the sigmoid and descending colon. During this assessment participants were asked to report when they had the first perception of pain. The investigator recorded the threshold pressure at which the participants reported this sensation.|approximately 60 minutes after drug administration|||mm Hg||Standard Deviation|Mean
815704|NCT01094886|Secondary|Summary of Change From Day 1 to Day 3 in AUC of Prothrombin Time|Descriptive statistics for AUC on Study Day 1 and Day 3 for prothrombin time, based on the 7 consecutive blood draws at 0, 2, 4, 6, 8, 12 and 24 hours post dose|Day 1, Day 3|ITT population: All subjects who received study drug and had valid post-dose data collected for efficacy analysis||sec*hour||Standard Deviation|Mean
815705|NCT01094886|Secondary|Summary of Change From Day 1 to Day 3 in Area Under the Curve (AUC) of aFXa|Descriptive statistics for Area Under the Curve (AUC) on Study Day 1 and Day 3 for Anti-Factor Xa, based on the 7 consecutive blood draws at 0, 2, 4, 6, 8, 12 and 24 hours post dose|Day 1, Day 3|ITT population: All subjects who received study drug and had valid post-dose data collected for efficacy analysis||IU/ml*hour||Standard Deviation|Mean
815706|NCT01094886|Primary|Summary of Change From Day 3 to Day 1 in Maximum Prothrombin Time|Descriptive statistics for per-patient maximum prothrombin time laboratory value selected from the 7 consecutive blood draws (0, 2, 4, 6, 8, 12 and 24 hrs post dose) on Day 1 and Day 3|Day 1, Day 3|ITT population: All subjects who received study drug and had valid post-dose data collected for efficacy analysis||sec||Standard Deviation|Mean
815707|NCT01094886|Primary|Summary of Change From Day 3 to Day 1 in Maximum Anti-Factor Xa (aFXa)|Descriptive statistics for per-patient maximum Anti-Factor Xa laboratory value selected from the 7 consecutive blood draws (0, 2, 4, 6, 8, 12 and 24 hrs post dose) on Day 1 and Day 3|Day 1, Day 3|ITT population: All subjects who received study drug and had valid post-dose data collected for efficacy analysis.||IU/ml||Standard Deviation|Mean
815708|NCT01100502|Secondary|Incidence of Anti-therapeutic Antibodies (ATA) to Brentuximab Vedotin||Up to 12 months|ATA-evaluable patients (patients with a baseline and at least 1 postbaseline sample)||participants|||Number
815709|NCT01100502|Secondary|Incidence of Adverse Events or Laboratory Abnormalities||Up to 12 months|Safety Analysis Set includes all patients who received at least 1 dose of brentuximab vedotin or only received placebo: 2 patients randomized to placebo received a single dose of brentuximab vedotin and are included in the brentuximab vedotin arm; 2 patients randomized to placebo received no study treatment and are not included in the analysis||participants|||Number
815710|NCT01100502|Secondary|Overall Survival|Time from date of randomization to date of death due to any cause|Up to approximately 10 years||04/2021||||
815711|NCT01100502|Primary|Progression-free Survival by Independent Review|Time from date of randomization to the first documentation of disease progression by independent review or to death due to any cause, whichever comes first|Up to approximately 4 years|Intention-to-Treat analysis set||months||95% Confidence Interval|Median
815712|NCT01100567|Secondary|Change From Baseline in Bone Specific Alkaline Phosphatase||baseline to 5 days|||ug/L/day||95% Confidence Interval|Mean
815713|NCT01100567|Primary|Change From Baseline in C-telopeptides||Baseline to 5 days|||ng/mL/day||95% Confidence Interval|Mean
815714|NCT01100606|Primary|Question 6 (Previous Pancreatic Enzyme Product [PEP])|"Acceptability questionnaire consists of 9 questions (Q) to assess the ease, time, overall satisfaction of study drug. Q6 included name of previous PEP administered. Q6 was reported as number of participants who used any PEP prior to screening."|Baseline|Safety analysis population included all participants who received at least 1 dose of study medication.||participants|||Number
815715|NCT01100606|Primary|Treatment Difference for Acceptability of Treatment|Acceptability questionnaire consists of 9 question (Q) to assess ease, time, overall satisfaction of study drug. Rated on 5-point scale for Q1-Q5 and Q7-Q9; Q6 was not rated and asked for name of previous PEP administered. Q1=overall ease of administration (1=not at all easy,2=somewhat,3=easy,4=very,5=extremely); Q2=time of administration (1=very short[<2 min],2=short[2-5 min],3=moderate[5-15 min],4=long[15-25 min],5=very long[>25 min]);Q3=overall infant acceptance(1=very easily,2=easily,3=same,4=with difficulty,5=with great difficulty);Q4=clear/complete instructions(1=not clear,2=somewhat,3=clear,4=very,5=extremely);Q5=overall satisfaction with dosing method (1=not satisfied,2=somewhat,3=satisfied,4=very,5=extremely);Q7=comparative ease of administration (1=much worse,2=worse,3=same,4=better,5=much better);Q8=comparative infant acceptance (1=much more difficult,2=more,3=same,4=easier,5=much easier);Q9=comparative overall satisfaction (1=much less,2=less,3=same,4=more,5=much more).|Baseline up to end of study (Day 21)|Intention-to-treat (ITT) population included all participants who received at least 1 dose of study medication, had data (partial or complete) on acceptability questionnaire and clinical signs and symptoms of exocrine pancreatic insufficiency (EPI). Here, 'N' (number of participants analyzed) =participants who were evaluable for this measure.||units on a scale||Full Range|Median
815716|NCT01100606|Secondary|Number of Participants With Abnormal Findings With Respect to Oral Mucosa|Safety assessed by the presence of lesions observed during a physical examination at each visit. Severity of lesions measured by investigator's assessment using the following scale: mild = asymptomatic or mild symptoms and treatment not indicated; moderate = moderate pain but not interfering with oral intake, modified diet indicated; severe = severe pain, interfering with oral intake and life threatening or fatal.|Baseline up to end of study (Day 21)|Safety population included all participants who received at least 1 dose of study medication.||participants|||Number
815717|NCT01100606|Secondary|Number of Participants With Abnormal Clinical Laboratory and Vital Signs Findings||Baseline up to end of study (Day 21)|Data was reported in individual participant listings but not statistically summarized for analysis as planned.|||||
815718|NCT01100606|Secondary|Number of Abdominal Pain Symptoms|Symptoms of pain was classified by severity as 0=none, 1=mild (no impairment of daily activities), 2=moderate (slight impairment of daily activities), and 3=severe (unable to perform daily activities). Average number of symptoms of specific severity for each participant was calculated from frequency of symptoms by the participant per day. Average number of symptoms during the first treatment period, second treatment period and end of study for total participants was summarized.|Up to Day 10 in first and second treatment periods, end of study (Day 21)|ITT population included all participants who received at least 1 dose of study medication, had data (partial or complete) on acceptability questionnaire and clinical signs and symptoms of EPI. Here, 'N' (number of participants analyzed) =participants who were evaluable for this measure.||average number of pain symptoms per day||Standard Deviation|Mean
815719|NCT01100606|Secondary|Number of Abdominal Symptoms: Flatulence|Flatulence is presence of excessive gas in the digestive tract. Symptoms of flatulence were classified by severity as 0=none, 1=mild (no impairment of daily activities), 2=moderate (slight impairment of daily activities), and 3=severe (unable to perform daily activities). Average number of symptoms of specific severity for each participant was calculated from frequency of symptoms by the participant per day. Average number of symptoms during the first treatment period, second treatment period and end of study for total participants was summarized.|Up to Day 10 in first and second treatment periods, end of study (Day 21)|ITT population included all participants who received at least 1 dose of study medication, had data (partial or complete) on acceptability questionnaire and clinical signs and symptoms of EPI. Here, 'N' (number of participants analyzed) =participants who were evaluable for this measure.||average number of flatulence per day||Standard Deviation|Mean
815731|NCT01100723|Primary|Percent of Patients Achieving Parathyroid Hormone Target ≤ 300|Compare the percent of patients achieving an intact Parathyroid hormone (PTH) target of ≤ 300 pg/ml before and after the application of a computerized dosing protocol for management of chronic kidney disease-mineral and bone disorder (CKD-MBD). If multiple values were obtained within a specified evaluation time frame the values were averaged and the average value was then evaluated as to whether it was within or outside the target range.|1 year|Subjects who had at least one laboratory measurement during the assessment phase.||percentage of subjects meeting target|||Number
839181|NCT01324622|Secondary|Quality of Life Improvement Using the SF-12 Scale||up to 24 months|Due to the study’s early termination, no data were collected for this outcome|||||
815720|NCT01100606|Secondary|Number of Abdominal Symptoms: Bloating|Bloating is swelling of the intestinal tract caused by excessive gas formation. Symptoms of bloating were classified by severity as 0=none, 1=mild (no impairment of daily activities), 2=moderate (slight impairment of daily activities), and 3=severe (unable to perform daily activities). Average number of symptoms of specific severity for each participant was calculated from frequency of symptoms by the participant per day. Average number of symptoms during the first treatment period, second treatment period and end of study for total participants was summarized.|Up to Day 10 in first and second treatment periods, end of study (Day 21)|ITT population included all participants who received at least 1 dose of study medication, had data (partial or complete) on acceptability questionnaire and clinical signs and symptoms of EPI. Here, 'N' (number of participants analyzed) =participants who were evaluable for this measure.||average number of bloating per day||Standard Deviation|Mean
815721|NCT01100606|Secondary|Number of Stools With Signs of Blood and Visible Oil or Grease|Average number of stools with signs of blood and visible oil or grease of each participant was calculated from number of stools with signs of blood and visible oil or grease by the participant per day. Average number of stools with signs of blood and visible oil or grease during the first treatment period, second treatment period and end of study for total participants was summarized.|Up to Day 10 in first and second treatment periods, end of study (Day 21)|ITT population included all participants who received at least 1 dose of study medication, had data (partial or complete) on acceptability questionnaire and clinical signs and symptoms of EPI. Here, 'N' (number of participants analyzed) =participants who were evaluable for this measure.||average number of stools per day||Standard Deviation|Mean
815722|NCT01100606|Secondary|Number of Stools Categorized as Per Consistency|Stool consistency was categorized as hard, formed/normal, soft and diarrhea. Average number of stools categorized as per consistency of each participant was calculated from number of stools of specific consistency by the participant per day. Average number of stools categorized as per consistency during the first treatment period, second treatment period and end of study for total participants was summarized.|Up to Day 10 in first and second treatment periods, end of study (Day 21)|ITT population included all participants who received at least 1 dose of study medication, had data (partial or complete) on acceptability questionnaire and clinical signs and symptoms of EPI. Here, 'N' (number of participants analyzed) =participants who were evaluable for this measure.||average number of stools per day||Standard Deviation|Mean
815723|NCT01100606|Secondary|Daily Number of Stools|Average daily number of stools of each participant was calculated from frequency of stools by the participant per day. Average daily number of stools during the first treatment period, second treatment period and end of study for total participants was summarized.|Up to Day 10 in first and second treatment periods, end of study (Day 21)|ITT population included all participants who received at least 1 dose of study medication, had data (partial or complete) on acceptability questionnaire on and clinical signs and symptoms of EPI. Here, 'N' (number of participants analyzed) =participants who were evaluable for this measure.||average number of stools per day||Standard Deviation|Mean
815724|NCT01100658|Secondary|Changes in Parent and Teacher Ratings of Attention, Executive Functioning and Behavior|Parent and teacher ratings of attention, executive function and behavior (i.e., Behavior Rating Inventory of Executive Function [BRIEF -a parent questionnaire and a teacher questionnaire-designed to assess executive functioning in home and school environments. Conners Parent Rating Scale-3 Short Form [CPRS-3 research and clinical tool for obtaining parental reports of childhood behavior problems.] Standard scores average = 50 + or - 10. Higher scores indicate more severe difficulty. Scores > or = 60 represent areas of significant behavior concern.|Week 1 and Week 2|No patients received treatment, therefore analysis was not done.|||||
815725|NCT01100658|Primary|Effectiveness of Methylphenidate on Neurocognitive Components|Child performance on neuropsychological testing (i.e., using Test of Variables of Attention [TOVA] which is a computerized test of attention that assists in the screening, diagnosis, and treatment monitoring of attention disorders, like Attention Deficit Hyperactivity Disorder [ADHD], and working memory index of the WisSC IV. Standard scores average = 100 +/- 15. Higher scores indicate better performance. Scores < or = 1 SD below the mean represent area of deficit.|Week 1 and Week 2|No patients received treatment, therefore analysis was not done.|||||
815726|NCT01100723|Secondary|Percent of Patients on Cinacalcet and Vitamin D Analogues|Compare the percent of patients on cinacalcet and vitamin D analogues at baseline and at 6 and 12 months after the application of a computerized dosing protocol for management of CKD-MBD. If multiple values were obtained within a specified evaluation time frame the values were averaged and the average value was then evaluated as to whether it was within or outside the target range.|6 months and 1 year|Number of subjects with at least 1 laboratory analysis during the evaluation period.||percentage of subjects receiving med|||Number
815727|NCT01100723|Secondary|Percent of Patients Achieving Calcium Target ≤ 10.1|Compare the percent of patients achieving a calcium ≤ 10.1 mg/dL before and after the application of a computerized dosing protocol for management of CKD-MBD. If multiple values were obtained within a specified evaluation time frame the values were averaged and the average value was then evaluated as to whether it was within or outside the target range.|1 year|Subjects with at least one laboratory value during evaluation period.||percentage of subjects in target|||Number
815728|NCT01100723|Secondary|Percent of Patients Achieving Phosphorous Target ≤ 4.5|Compare the percent of patients achieving a phosphorus of ≤ 4.5 mg/dL before and after the application of a computerized dosing protocol for management of CKD-MBD. If multiple values were obtained within a specified evaluation time frame the values were averaged and the average value was then evaluated as to whether it was within or outside the target range.|1 year|||percent of participants in target|||Number
815729|NCT01100723|Secondary|Percent of Patients Achieving Parathyroid Hormone Target ≤ 450|Compare the percent of patients achieving an intact PTH target of ≤ 450 pg/ml before and after the application of a computerized dosing protocol for management of CKD-MBD. If multiple values were obtained within a specified evaluation time frame the values were averaged and the average value was then evaluated as to whether it was within or outside the target range.|1 year|||percent of participants in target|||Number
815730|NCT01100723|Primary|Percent of Patients Achieving Phosphorous Target ≤ 5.5|Compare the percent of patients achieving a phosphorus of ≤ 5.5 mg/dL before and after the application of a computerized dosing protocol for management of CKD-MBD. If multiple values were obtained within a specified evaluation time frame the values were averaged and the average value was then evaluated as to whether it was within or outside the target range.|1 year|||percent of participants in target|||Number
815733|NCT01100762|Primary|First Step Length|First step length was measured in meters from the starting position of the foot to the maximum displacement of the foot after the first step. Measurements were taken separately for forward and backward first step.|Data collection occurred before and immediately after each training session|||m||Standard Deviation|Mean
815734|NCT01100762|Primary|Number of Steps to Regain Balance|Steps to regain balance were measured by the number of steps needed to recover standing balance. The steps were counted using a custom software of the motion capture system.|Data collection occurred before and immediately after each training session|||steps||Standard Deviation|Mean
815735|NCT01100762|Primary|Cadence|Cadence was measured in steps per minute|Data collection occurred before and immediately after each training session|||steps/min||Standard Deviation|Mean
815736|NCT01100762|Primary|Gait Velocity|Gait Velocity was measured in meters per second|Data collection occurred before and immediately after each training session|||m/s||Standard Deviation|Mean
815737|NCT01100762|Primary|Stride Length|Stride Length was measured in centimeters|Data collection occurred before and immediately after each training session|||cm||Standard Deviation|Mean
815738|NCT01101165|Primary|AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration|Bioequivalence based on AUC0-t|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects who experienced emesis within 12 hours after dosing were excluded from PK analysis. Note:One subject in period 2 was excluded from this PK analysis.||ng*h/mL||Standard Deviation|Mean
815739|NCT01101165|Primary|AUC0-inf - Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects who experienced emesis within 12 hours after dosing were excluded from PK analysis. Note:One subject in Period 2 was excluded from this PK analysis.||ng*h/mL||Standard Deviation|Mean
815740|NCT01101165|Primary|Cmax - Maximum Observed Plasma Concentration|Bioequivalence based on Cmax|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects who experienced emesis within 12 hours after dosing were excluded from PK analysis.||ng/mL||Standard Deviation|Mean
815741|NCT01101178|Primary|AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration|AUC0-t is the Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration and bioequivalence based on AUC0-t|Blood samples collected over 72-hour period|Full Analysis Population for Pharmacokinetic (PK) Metrics; Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects experiencing emesis within 12 hours after dosing were excluded from PK analysis.||ng*h/mL||Standard Deviation|Mean
815742|NCT01101178|Primary|AUC0-inf - Area Under Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)|AUC0-inf is the Area Under Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)and bioequivalence is based on AUC0-inf values.|Blood samples collected over 72-hour period|Full Analysis Population for pharmacokinetic (PK) Metrics: Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects experiencing emesis within 12 hours after dosing were excluded from PK analysis.||ng*h/mL||Standard Deviation|Mean
815743|NCT01101178|Primary|Cmax - Maximum Observed Plasma Concentration|Cmax is the Maximum Observed Plasma Concentration and bioequivalence is based on Cmax.|Blood samples collected over 72-hour period|Full Analysis Population for Pharmacokinetic (PK) Metrics: Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects experiencing emesis within 12 hours after dosing were excluded from PK analysis.||ng/mL||Standard Deviation|Mean
815744|NCT01101191|Primary|AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration|AUC0-t is the area under the plasma concentration-time curve from time zero to time of last non-zero plasma concentration and bioequivalence is based on AUC0-t.|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects who experienced emesis within 12 hours after dosing were excluded from PK analysis.||ng*h/mL||Standard Deviation|Mean
815745|NCT01101191|Primary|AUC0-inf - Area Under Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)|AUC0-inf is the area under the plasma concentration-time curve from time zero to infinity (extrapolated) and bioequivalence is based on AUC0-inf.|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis.Subjects who experienced emesis within 12 hours after dosing were excluded from PK analysis.||ng*h/mL||Standard Deviation|Mean
815746|NCT01101191|Primary|Cmax - Maximum Observed Plasma Concentration|Cmax is the maximum observed plasma concentration and bioequivalence is based on Cmax.|Blood samples collected over a 72-hour period.|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis.Subjects who experienced emesis within 12 hours after dosing were excluded from PK analysis.||ng/mL||Standard Deviation|Mean
815747|NCT01101308|Primary|AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration|AUC0-t is the area under the plasma concentration-time curve from time zero to time of last non-zero plasma concentration and bioequivalence is based on AUC0-t.|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects experiencing emesis within 12 hours after dosing were excluded from PK analysis.||ng*h/mL||Standard Deviation|Mean
815803|NCT01102218|Primary|Change in Erythropoietin Dose|Erythropoietin dose is amount needed to maintain a hemoglobin between 11 and 12 mg/dL.|Baseline and 6 months|The number of patients for analysis was based on those patient who had completed 6 months of treatment. The analysis was per protocol.||Units EPO||Standard Deviation|Mean
815748|NCT01101308|Primary|AUC0-inf - Area Under Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)|AUC0-inf is the area under the plasma concentration-time curve from time zero to infinity (extrapolated) and bioequivalence is based on AUC0-inf.|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects experiencing emesis within 12 hours after dosing were excluded from PK analysis.||ng*h/mL||Standard Deviation|Mean
815749|NCT01101308|Primary|Cmax - Maximum Observed Plasma Concentration|Cmax is the maximum observed plasma concentration and bioequivalence is based on Cmax.|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects experiencing emesis within 12 hours after dosing were excluded from PK analysis.||ng/mL||Standard Deviation|Mean
815750|NCT01101321|Primary|AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration|Bioequivalence based on AUC0-t|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
815751|NCT01101321|Primary|AUC0-inf - Area Under Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
815752|NCT01101321|Primary|Cmax - Maximum Observed Plasma Concentration|Bioequivalence based on Cmax|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
815753|NCT01101464|Primary|Pharmacokinetic Parameter of Area Under the Curve (AUC) of Two Differing Tablet Strengths (3 x 5 mg and 1 x 15 mg) of Sublingually Administered Org 5222 (Asenapine)|"The primary objective is to compare the bioavailability using pharmacokinetic parameter of area under the curve (AUC) of two differing tablet strengths (3 x 5 mg and 1 x 15 mg) of sublingually administered Org 5222.
Measurements were performed after each cross-over period: Day 5 measurement for 3x5mg for participants from Sequence 1 and 1x15mg for participants from Sequence 2; Day 7 measurement for 1x15mg for participants from Sequence 1 and 3x5mg for participants from Sequence 2."|Day 5 & Day 7|All participants were included in both treatment comparisons (as per cross over design).||ng*h/mL||Standard Deviation|Mean
815754|NCT01101464|Primary|Pharmacokinetic Parameter of Time of Occurrence of Cmax (Tmax) of Two Differing Tablet Strengths (3 x 5 mg and 1 x 15 mg) of Sublingually Administered Org 5222 (Asenapine)|"The primary objective is to compare the bioavailability using pharmacokinetic parameter of time of occurrence of Cmax (Tmax) of two differing tablet strengths (3 x 5 mg and 1 x 15 mg) of sublingually administered Org 5222.
Measurements were performed after each cross-over period: Day 5 measurement for 3x5mg for participants from Sequence 1 and 1x15mg for participants from Sequence 2; Day 7 measurement for 1x15mg for participants from Sequence 1 and 3x5mg for participants from Sequence 2"|Day 5 & Day 7|All participants were included in both treatment comparisons (as per cross over design).||Hours||Full Range|Mean
815755|NCT01101464|Primary|Pharmacokinetic Parameter of Maximum Plasma Concentration (Cmax) of Two Differing Tablet Strengths (3 x 5 mg and 1 x 15 mg) of Sublingually Administered Org 5222 (Asenapine)|"The primary objective is to compare the bioavailability using pharmacokinetic parameter of maximum plasma concentration (Cmax) of two differing tablet strengths (3 x 5 mg and 1 x 15 mg) of sublingually administered Org 5222
Measurements were performed after each cross-over period: Day 5 measurement for 3x5mg for participants from Sequence 1 and 1x15mg for participants from Sequence 2; Day 7 measurement for 1x15mg for participants from Sequence 1 and 3x5mg for participants from Sequence 2."|Day 5 & Day 7|All participants were included in both treatment comparisons (as per cross over design).||ng/mL||Standard Deviation|Mean
815756|NCT01101477|Secondary|The Global Tolerance for Flexible Bronchoscopy|After the recovery, patients will be asked about the tolerance of bronchoscopy performed to them by 10-point Verbal Analogus Scale (0: best tolerance, 10: worst tolerance)|After recovery||||||
815757|NCT01101477|Secondary|The Cooperation of Patients From the View of Bronchoscopists|After the bronchoscopy, the bronchoscopist will be asked by 10-point Verbal Analogus Scale (0: the best cooperation, 10: the worst cooperation) to express how they fell about the cooperation of patients undergoing the bronchoscopy.|After bronchoscopy||||||
815758|NCT01101477|Secondary|The Total Doses of Propofol During Induction and Overall Procedures|The dosses of propofol used during induction and overall flexible bronchoscopy will be recored from the screen of the TCI pump.|after bronchoscopy||||||
815759|NCT01101477|Secondary|The Recovery Time to Orientation|The recovery time to orientation was defined as the time between finishing bronchoscopy to the time when the patients could spontaneously open their eyes, recall their date of birth, and correctly perform finger-nose test.|after bronchosocpy||||||
815760|NCT01101477|Primary|The Number of Changes in Target Effect Site Concentration During Flexible Bronchoscopy|The investigator will titrate the target effect site concentration (Cet) during bronchoscopy according to protocol to keep stable vital signs and sedative levels. The numbers of adjustment will be recorded to show which regimen required less adjustment to keep stable sedative levels and vital signs.|During sedative induction and bronchoscopy||||||
815761|NCT01101477|Primary|The Number of Patients With Hypoxemia During Flexible Bronchoscopy|"Hypoxemia is defined as:
Oxyhemoglobin saturation (SPO2) is less than 90 % with any duration"|During sedative induction and bronchoscopy|The participants who received intervention completely were analyzed.||participants|||Number
815804|NCT01102257|Primary|Change in REd Blood Cell(RBC) Membrane Fatty Acid(FA) Content||Baseline and 3 Months|||Percentage Total Fatty Acids||Inter-Quartile Range|Median
815805|NCT01102257|Secondary|Change in Relevant Biomarkers: HLA-DR, MUC 5A, Cytokines||90 +/- 14 days following initiation of drug regimen||||||
815806|NCT01102257|Secondary|Change in Schirmer’s||90 +/- 14 days following initiation of drug regimen||||||
815807|NCT01102257|Secondary|Change in the Ocular Surface||90 +/- 14 days following initiation of drug regimen||||||
815808|NCT01102257|Secondary|Change in Quality of Life Associated With Chronic Pain||90 +/- 14 days following initiation of drug regimen||||||
815762|NCT01101542|Primary|Number of Subjects With Medically Significant Conditions.|MSC include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|During the entire Post Marketing Surveillance period up to one month after the third vaccine dose (During the 4th, 5th and 6th year of surveillance)|The analysis was performed on the Total Vaccinated cohort that included all vaccinated subjects with at least one dose of Cervarix vaccine administration documented.||Subjects|||Number
815763|NCT01101542|Primary|Number of Subjects Reporting Serious Adverse Event (SAEs) and SAE(s) Causally Related to Vaccination.|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|During the entire Post Marketing Surveillance period up to one month after the third vaccine dose (During the 6th year of surveillance).|||Subjects|||Number
815764|NCT01101542|Primary|Number of Subjects Reporting Serious Adverse Event (SAEs) and SAE(s) Causally Related to Vaccination.|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|During the entire Post Marketing Surveillance period up to one month after the third vaccine dose (During the 5th year of surveillance).|||Subjects|||Number
815765|NCT01101542|Primary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 30-day period (Day 0 to Day 29) following any vaccination (During the 6th year of surveillance).|||Subjects|||Number
815766|NCT01101542|Primary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 30-day period (Day 0 to Day 29) following any vaccination (During the 5th year of surveillance).|||Subjects|||Number
815767|NCT01101542|Primary|Number of Subjects With Medically Significant Conditions.|*Note: For Surveillance Year 3 the analysis was not performed for this outcome since it was not a requirement of the Korean regulatory authority.|During the entire Post Marketing Surveillance period up to one month after the third vaccine dose (During the 3rd, 4th, 5th and 6th year of surveillance)|*Note: the analysis was not performed for this outcome since it was not a requirement of the Korean regulatory authority.|||||
815768|NCT01101542|Primary|Number of Subjects Reporting Serious Adverse Event (SAEs) and SAE(s) Causally Related to Vaccination.|"SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Note: Results for the 5th and 6th year of surveillance will be added when they become available."|During the entire Post Marketing Surveillance period up to one month after the third vaccine dose (During the 4th year of surveillance).|The analysis was performed on the Total Vaccinated cohort that included all vaccinated subjects with at least one dose of Cervarix vaccine administration documented.||Subjects|||Number
815769|NCT01101542|Primary|Number of Subjects Reporting Serious Adverse Event (SAEs) and SAE(s) Causally Related to Vaccination.|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|During the entire Post Marketing Surveillance period up to one month after the third vaccine dose (During the 3rd year of surveillance).|The analysis was performed on the Total Vaccinated cohort that included all vaccinated subjects with at least one dose of Cervarix vaccine administration documented.||Subjects|||Number
815770|NCT01101542|Primary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|"An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Note: Results for the 5th and 6th year of surveillance will be added when they become available."|During the 30-day period (Day 0 to Day 29) following any vaccination (During the 4th year of surveillance).|The analysis was performed on the Total Vaccinated cohort that included all vaccinated subjects with at least one dose of Cervarix vaccine administration documented.||Subjects|||Number
815771|NCT01101542|Primary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 30-day period (Day 0 to Day 29) following any vaccination (During the 3rd year of surveillance).|The analysis was performed on the Total Vaccinated cohort that included all vaccinated subjects with at least one dose of Cervarix vaccine administration documented.||Subjects|||Number
815809|NCT01102257|Secondary|Change on Impact of Dry Eye on Everyday Life (IDEEL)||90 +/- 14 days following initiation of drug regimen||||||
815810|NCT01102257|Secondary|Change on Brief Ocular Discomfort Inventory (BODI)||90 +/- 14 days following initiation of drug regimen||||||
815811|NCT01102257|Primary|Change on Ocular Surface Disease Index (OSDI)||90 +/- 14 days following initiation of drug regimen||||||
815812|NCT01102270|Secondary|Sleep Duration|total sleep duration|8 hour In-Laboratory Polysomnogram (PSG)|||hours of sleep||Standard Error|Mean
815772|NCT01101841|Primary|Mean Change From Baseline in Hot Flash Severity at Week 4 and Week 12.|"Subjects recorded the number of hot flashes per week using an electronic diary. Severity score for hot flashes for each subject was calculated as the sum of 2 times the number of moderate hot flashes, plus 3 times the number of severe hot flashes, divided by the total number of moderate and severe hot flashes.
Weekly Severity Score = (2•Fm +3•FS)/(Fm + FS) Daily Severity Score = {(2•F) m +3•FS)/(Fm + FS)}/7 Where, Fm= Frequency of Moderate Hot Flashes Fs = Frequency of Severe Hot Flashes"|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.||Hot Flash Severity Score per day||Standard Deviation|Mean
815773|NCT01101841|Secondary|BMI Change From Baseline (kg/m2), Median|"Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary.
Assessment of the effect of Brisdelle compared with placebo on body mass index."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.||kg/m2||Full Range|Median
815774|NCT01101841|Secondary|Assessment of Mood|"Mood was measured by using the Profile of Mood States (POMS) questionnaire. The Profile of Moods States (POMS) is a 65-item multi-dimensional measure that provides a method of assessing transient, fluctuating active mood states. Key areas that are measured include: tension-anxiety, anger-hostility, fatigue-inertia, depression-dejection, vigor-activity, confusion-bewilderment. Responses to questions are scored with the following numerical values: Not at all = 1, A little = 2, Moderate = 3, Quite a bit = 4, Extremely = 5. A total score for a domain was obtained by summing the responses of individual items in the domain. The total POMS score can range from 65 to 325. Each subject’s total POMS score at baseline and at Week 4 and Week 12 were used to calculate the percent of participants with less disturbance in mood at Week 4 and Week 12 compared to baseline. The percent of participants with less disturbance in mood is reported below."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.||Percent of participants|||Number
815775|NCT01101841|Secondary|Effect of Brisdelle (Paroxetine Mesylate) Capsules on Anxiety and Depression|"Depression & anxiety were measured by using the Hospital Anxiety & Depression Scale (HADS).
The HADS was developed to assess anxiety & depression. It is meant to differentiate symptoms of depression with those of anxiety.
Number of items: 14 (7 questions relating to anxiety; 7 questions relating to depression).
Responses are based on the relative frequency of symptoms over the past week, using a four point scale ranging from 0 (not at all) to 3 (very often indeed).
Responses are summed to provide separate scores for anxiety and depression symptomology with possible scores ranging from 0 to 21 for each scale.
The results presented below are the percentage of participants with abnormal HADS Scores for both Abnormal Anxiety & Abnormal Depression at Week 4 and Week 12."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.||Percentage of participants|||Number
815776|NCT01101841|Secondary|Percent Responders Improvement in VMS From Baseline Using the Clinical Global Impression (CGI) Scale.|"Proportion of NRS Responders: Subject’s overall improvement in VMS from Baseline was assessed using the Numerical Rating Scale (NRS)
The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.
Responders: Subjects Achieving a Score of “Very Much Improved” Or “Much Improved” Or “Minimally Improved”.
Non Responders: Subjects with a Score of “No Change” Or “Minimally Worse” Or “Much Worse” Or “Very Much Worse”."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.||percentage of participants|||Number
815777|NCT01101841|Secondary|Effect of Paroxetine Mesylate Capsules on Percent Improvement of Hot Flash Interference From Baseline at Week 4 and Week 12, Hot Flash Related Daily Interference Scale (HFRDIS)|"Interference of hot flashes was measured by using the hot flash-related daily interference scale (HFRDIS). The HFRDIS is a 10-item scale that measures the degree to which hot flashes interfere with 9 daily activities and the tenth item measures the degree to which hot flashes interfere with each of the other items. Subjects can score for each item on a scale from 0 to 10 where 0 = Do not interfere and a score of 10 = Completely interferes.
The measure being reported below is percentage of responders who had an improvement in HFRDIS score at Week 4 and Week 12 compared to baseline. A responder is defined as a subject who had an improvement in the HFRDIS score. An improvement is defined as a score ≤3 on each question."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.||Percent of participants|||Number
815813|NCT01102270|Primary|Apnea Hypopnea Index|number of respiratory events per hour of sleep Respiratory events last for at least 10 seconds and are associated with a decrease in blood oxygenation or a cortical arosual from sleep. AHI values are typically categorized as 5-15/hr = mild; 15-30/hr = moderate; and > 30/h = severe|8 hour In-Laboratory Polysomnogram (PSG)|||events per hour of sleep||Standard Error|Mean
815814|NCT01102270|Secondary|Nadir Overnight Oxygen Saturation|Nadir overnight oxygen saturation (%)|8 hour In-Laboratory Polysomnogram (PSG)|||% oxygen saturation||Standard Error|Mean
815815|NCT01102270|Secondary|Arousal Threshold|quantified using an epiglottic pressure transducer in CmH2O|8 hour In-Laboratory Polysomnogram (PSG)|||cmH2O||Inter-Quartile Range|Median
815778|NCT01101841|Secondary|Change From Baseline in Arizona Sexual Experience Scale (ASEX, Week 4 and Week 12) Total Score, Median|The Arizona Sexual Experiences Scale (ASEX) is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm. Possible total scores range from 5 to 30, with the higher scores indicating more sexual dysfunction.The sum of the scores for all 5 items was calculated at Week 4 and Week 12.|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.||Units on a scale||Full Range|Median
815779|NCT01101841|Secondary|Percent Daytime and Nighttime Responders, Numerical Rating Scale (NRS)|"Subject's overall improvement in VMS from Baseline assessed using the Numerical Rating Scale (NRS) The NRS is measured on a scale of 0 to 10 on how bothered the subject was by her VMS (0=not bothered at all and 10=very much bothered).
Responders: Subjects with NRS Score of 5 Or Less. Non-Responders: Subjects With NRS Score of Greater than Or Equal to 6."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.||percentage of total number of subjects|||Number
815780|NCT01101841|Secondary|Percentage of Responders|Participants reported the number of hot flashes using an electronic diary. Participants who hd a ≥50% reduction in hot flash frequency were defined as responders. The percent of responders is presented below.|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.||percentage of participants|||Number
815781|NCT01101841|Secondary|Change From Baseline in Greene Climacteric Scale (GCS) at Week 4 and Week 12, Total Score, Median|"The Greene Climacteric Scale (GCS) was used for this measurement. The scale has 21 questions and measures symptoms in 4 areas; these are psychological (anxiety and depression), physical, vasomotor, and libido.
The severity of the symptom was scored as: 0=none, 1=mild, 2=moderate, and 3=severe. Anxiety was determined by using the sum of scores 1 to 6, and depression was determined by using the sum of scores 7 to 11. Physical aspects were determined by using the sum of scores 12 to 18; vasomotor aspects were determined by using the sum of scores 19 to 20; and libido was determined by using the score for question 21.
The total GCS score ranges from 0 to 63 which is the sum of all the scores for the 21-symptom assessment questions in this scale. Each subject’s total GCS score at baseline and at Week 4 and Week 12 were used to calculate change from baseline in these symptoms. The change from baseline is reported below."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.||units on a scale||Full Range|Median
815782|NCT01101841|Secondary|Change in Severity of Moderate to Severe Hot Flashes From Baseline (BMI ≥32 kg/m2, Week 4 and Week 12), Median|"Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary.
For the BMI ≥32 kg/m2 subgroup, the mean weekly reduction in the severity of moderate to severe hot flashes from Baseline was calculated at Week 4 and Week 12.
Subjects recorded the number of hot flashes per week using an electronic diary. Severity score for hot flashes for each subject was calculated as the sum of 2 times the number of moderate hot flashes, plus 3 times the number of severe hot flashes, divided by the total number of moderate and severe hot flashes.
Weekly Severity Score = (2•Fm +3•FS)/(Fm + FS) Daily Severity Score = {(2•F) m +3•FS)/(Fm + FS)}/7 Where, Fm= Frequency of Moderate Hot Flashes Fs = Frequency of Severe Hot Flashes The calculated severity score is reported below."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.||Hot Flash Severity scores per week||Full Range|Median
815783|NCT01101841|Secondary|Change in Severity of Moderate to Severe Hot Flashes From Baseline (BMI <32 kg/m2, At Week 4 and Week 12), Median|"Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary.
For the BMI <32 kg/m2 subgroup, the mean weekly reduction in the severity of moderate to severe hot flashes from Baseline was calculated at Week 4 and Week 12.
Subjects recorded the number of hot flashes per week using an electronic diary. Severity score for hot flashes for each subject was calculated as the sum of 2 times the number of moderate hot flashes, plus 3 times the number of severe hot flashes, divided by the total number of moderate and severe hot flashes.
Weekly Severity Score = (2•Fm +3•FS)/(Fm + FS) Daily Severity Score = {(2•F) m +3•FS)/(Fm + FS)}/7 Where, Fm= Frequency of Moderate Hot Flashes Fs = Frequency of Severe Hot Flashes The calculated severity score is reported below."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.||Hot Flash Severity scores per week||Full Range|Median
815784|NCT01101841|Secondary|Change in Frequency of Moderate to Severe Hot Flashes Frequency From Baseline (BMI ≥32 kg/m2, Week 4 and Week 12), Median|"Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary.
For the BMI ≥32 kg/m2 subgroup, the mean weekly reduction in frequency of moderate to severe hot flashes from Baseline was calculated for Week 4 and Week 12."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.||Hot flashes per week||Full Range|Median
815816|NCT01102374|Secondary|Number of Other Infections||12 months|||events|||Number
815817|NCT01102374|Secondary|Number of Urinary Tract Infections||12 months|||events|||Number
815818|NCT01102374|Secondary|Death||12 months|||Participants|||Count of Participants
815819|NCT01102374|Secondary|Incident Hypercalcemia||12 months|||Participants|||Count of Participants
815785|NCT01101841|Secondary|Change From Baseline in Total Number of Awakenings Due to Hot Flashes, Median|"Participants completed a electronic diary to report nightime awakenings. Subjects took study drug once daily at bedtime and they were instructed to complete daily hot flash and sleep diaries to record the number of hot flashes daily, the severity of each episode of hot flash and total number of awakenings due to hot flashes.
The diary data was used to evaluate and compare the treatment groups, on the change from baseline to Week 4 and Week 12, in the total number of awakenings due to hot flashes. The total number of awakenings due to hot flashes in the run-in period was used as baseline."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.||Awakenings||Full Range|Median
815786|NCT01101841|Secondary|Change in Frequency of Moderate to Severe Hot Flashes Frequency From Baseline (BMI <32 kg/m2, Week 4 and Week 12), Median|"Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary.
For the BMI <32 kg/m2 subgroup, the mean weekly reduction in frequency of moderate to severe hot flashes from Baseline was calculated for Week 4 and Week 12."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.||Hot flashes per week||Full Range|Median
815787|NCT01101841|Secondary|Percent Persistence of Benefit, Statistically Significant Difference in Having 50% or More Reduction Compared to Baseline at Week 24.|"Persistence of treatment benefit to 24 weeks post treatment was assessed by using the following responder analysis. Responders were defined as those subjects who achieved ≥ 50% reduction from baseline in moderate to severe hot-flash frequency at Week 24; the percent change in hot flash frequency is calculated using the formula:
Percent reduction at week 24 = [(number of moderate to severe hot flash frequency at baseline – number of moderate to severe hot flash frequency at week 24) / number of moderate to severe hot flash frequency at baseline ]*100%."|Week 24|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.||percentage of total number of subjects|||Number
815788|NCT01101841|Primary|Mean Change From Baseline in Hot Flash Frequency at Week 4 and Week 12.|"Subjects recorded the number of hot flashes per week using an electronic diary. The results reported are not hot flashes per week.
The results reported are:
Mean Baseline frequency of moderate to severe VMS
Mean change in frequency of moderate to severe VMS from baseline to Week 4
Mean change in frequency of moderate to severe VMS from baseline to Week 12"|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.||Hot flashes per day||Standard Deviation|Mean
815795|NCT01101958|Primary|Lung Volume Change||30 Days|Per protocol population analyzed [16 subjects have been excluded due to the following reasons: lacked HRCT(n=6), Lost to Follow-Up (n=8) or died (n=2) of unrelated causes].||percent decrease in lung volume||Inter-Quartile Range|Median
815796|NCT01101971|Primary|Score on Pelvic Exam Assessment Tool|A pelvic exam assessment score out of 30 is recorded by a Resident examiner immediately after a student completes their first pelvic examination on a mock patient. Pass = 15/30 (50%).|15 minutes|||points||Standard Deviation|Mean
815797|NCT01102140|Secondary|Asymmetric Dimethylarginine (ADMA)|ADMA is a serum enzyme involved in metabolism of endothelium derived nitric oxide (NO). NO's has an important role in maintaining endothelial homeostasis. Elevated ADMA levels suggest impaired endothelial function.|baseline and 12 weeks|Serum samples were obtained and frozen but never analyzed to obtain ADMA values due to PI departure from study center prior to any batches being sent for analysis|||||
815798|NCT01102140|Secondary|Procollagen Types I (PINP) and III (PIIINP)|This is a serum marker of collagen turnover (fibrosis/scar formation).|baseline and 12 weeks|Serum samples were obtained and frozen but never analyzed to obtain procollagen values due to PI departure from study center prior to any batches being sent for analysis|||||
815799|NCT01102140|Secondary|F-8 Isoprostanes|This is a serum marker of oxidative stress.|Baseline and 12 weeks|Serum samples were obtained and frozen but never analyzed to obtain isoprostane values due to PI departure from study center prior to any batches being sent for analysis|||||
815800|NCT01102140|Primary|Thiobarbituric Reactive Substances (TBARS)|This is a serum marker of oxidative stress.|baseline and after 12 weeks|Serum samples were obtained and frozen but never analyzed to obtain isoprostane values due to PI departure from study center prior to any batches being sent for analysis.|||||
815801|NCT01102218|Secondary|Observe Changes in Markers of Inflammation Including But Not Limited to TNF-α and IL-6||6 months||||||
815802|NCT01102218|Secondary|Examine the EPO Resistance Index (Erythropoietin Dose/kg/Week/Hgb) or ERI Over Time||6 months||||||
815820|NCT01102374|Secondary|Incident Kidney Stones||12 months|||Participants|||Count of Participants
815821|NCT01102374|Secondary|Number of Influenza-like Illnesses||12 months|collected together with lower respiratory infections (not as a separate category)|||||
815831|NCT01102413|Secondary|Change in Hemoglobin Concentration From Baseline to Week 8||Baseline to week 8|The FAS population included all the subjects who were randomised into the study, received at least one dose of the study drug, and had at least one post-baseline Hb assessment. The subjects were considered as randomised, regardless of which treatment they actually received.||g/dL||Full Range|Mean
815832|NCT01102413|Primary|Change in Hemoglobin (Hb) Concentration From Baseline to Week 4.||Baseline, 4 weeks|The FAS population included all the subjects who were randomised into the study, received at least one dose of the study drug, and had at least one post-baseline Hb assessment. The subjects were considered as randomised, regardless of which treatment they actually received.||g/dL||Full Range|Mean
815833|NCT01102491|Secondary|Incidence of Rescue Antiemetic Administration|outcome assessor assessed the incidence of rescue antiemetic administration|within 48 hours after surgery||||||
815834|NCT01102491|Primary|Incidence of Nausea and Vomiting|outcomes assessor who is blinded to randomization assessed the incidence of postoperative nausea which was defined as subjectively unpleasant sensation associated with awareness of the urge to vomit and an emetic episode and vomiting|within 48 hours after surgery|||participants|||Number
815835|NCT01102764|Secondary|Prior Experience With Computer and Audiovisual Technology: Short Measure to Learn More About Participants' Prior Experience and Comfort Level With Computers and Audiovisual Technology||1 year||||||
815836|NCT01102764|Secondary|Structured Clinical Interview for DSM-IV: Interview to Diagnosis Depression, Panic Disorder, and Substance Abuse||1 year||||||
815837|NCT01102764|Secondary|Service Delivery Perceptions Questionnaire: Assess Subjects' Perceptions About Variables Specifically Related to the Mode of Service Delivery (Quality of Communication, Ease of Use, Willingness to Use Treatment)||1 year||||||
815838|NCT01102764|Secondary|Treatment Credibility: to Assess for Differences in Outcome Expectancy, Treatment Credibility Scales||1 year||||||
815839|NCT01102764|Secondary|Charleston Psychiatric Outpatient Satisfaction Scale (CPOSS-VA): 16 Item Self Report Scale, General Measure of Patient Satisfaction of Treatment||1 year||||||
815840|NCT01102764|Secondary|Health Related Functioning: Medical Outcome Study Short Study Forms-36 Health Survey (SF 36): Self Report Scale Measures Health Status and Functioning Over the Past Four Weeks||1 year||||||
815841|NCT01102764|Secondary|Deployment Risk and Resiliency Inventory (DRRI): Self Report Measure Assessing 14 Key Deployment-related Risk and Resilience Factors With Demonstrated Implications for Veterans' Long Term Health||1 year||||||
815842|NCT01102764|Secondary|Clinician Administered PTSD Scale (CAPS): PTSD Diagnosis||1 year||||||
815843|NCT01102764|Primary|BDI Scores at Pre and Post Treatment|Beck Depression Inventory-II (BDI-II): (BDI; Beck et al., 1961): The BDI-II is a 21-item self-report scale, is among the most widely used instruments to measure depression. Beck and Steer (1984) demonstrated that the BDI-I has high internal consistency (α = .86 - .91). Lower scores indicate less symptom severity, and higher scores indicate more severe depressive symptoms. Raw scores of 0-13 indicates minimal depression; 14-19 indicates mild depression; 20-28 indicates moderate depression; 29-63 indicates severe depression. The lowest possible score on this measure is 0, and the highest possible score is 63.|6 months|There were 150 participants enrolled in the study, and 132 completed at least one session and were thus analyzed. The numbers here reflect those participants who completed at least one session.||units on a scale||Full Range|Mean
815844|NCT01102764|Primary|PCL Scores at Pre and Post Treatment|PTSD Checklist-Military (PCL-M): The PCL is a 17 Item Self Report Measure of PTSD Symptoms Based on the DSM-IV Criteria. The PCL uses a 5-point Likert scale response format ranging from not at all to frequently. Total scores on the PCL range from 17 to 85 (lower scores indicate less symptom severity). The instrument is highly correlated with the Clinician Administered PTSD Scale (r = .93), has good diagnostic efficiency (> .70), and robust psychometrics with a variety of trauma populations (Blanchard, 1996), including combat veterans (Magruder, Frueh, et al, 2005). The minimum score possible on this measure is 17, and the highest possible score is 85.|6 months|There were 150 participants enrolled in the study, and 132 completed at least one session and were thus analyzed. The numbers here reflect those participants who completed at least one session.||units on a scale||Full Range|Mean
815845|NCT01102764|Primary|The Major Objective of This Study is to Determine if PE Delivered Via Telemedicine is as Effective as In Person PE in Terms of (1) Clinical (PTSD and Depression); (2) Process (Treatment Satisfaction and Attrition); and (3) Economic (Cost) Outcomes.|Per protocol treatment completers completed at least 6 90-minute sessions of Prolonged Exposure either In Person or via Telemedicine. Treatment dropout is defined as initiating treatment but completing fewer than 6 sessions. Per protocol, participants could have as many as 12 treatment sessions.|6 months|There were 150 participants enrolled in the study, and 132 completed at least one session and were thus analyzed. The numbers here reflect those participants who completed at least one session.||sessions||Full Range|Mean
815846|NCT01102777|Secondary|Change in Participant Satisfaction|"Change in participation satisfaction with the Intervention group from four to twelve months on a Likert scale of 1-5, where 1 is Definitely True 5 is Definitely False to the question, I would recommend the Taking Healthy Steps walking program to another person with COPD. A negative change value indicates higher satisfaction score."|four to twelve months of study participation|This was only assessed on Intervention group participants who answered the question at either four or twelve months.||units on a scale||95% Confidence Interval|Mean
815847|NCT01102777|Secondary|Participant Retention|The last valid day of pedometer data or the last login day to the study website for both arms, whichever day was last, from 1-366.|during study participation, up to twelve months|||day||95% Confidence Interval|Mean
815848|NCT01102777|Secondary|Study Reach Among Rural Participants|Calculated by dividing the total number of eligible rural responders by the total number of rural responders to create an eligibility rate, then multiplying the eligibility rate with the total number of letters sent to rural individuals to create a possible rural eligible pool. The total number of eligible rural responders was divided by the possible rural eligible pool.|At baseline|number of rural participants.||percentage of possible eligible rural|||Number
815905|NCT01103063|Secondary|Percentage of Neonates With Congenital Abnormalities at Birth|Neonates with congenital abnormalities at birth were noted.|Approximately 40 weeks of gestational age.|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus. N=Number of total live births.||Percentage of neonates||95% Confidence Interval|Number
815849|NCT01102777|Secondary|Goal Commitment for Intervention Participants|"Change in goal commitment for intervention participations on a Likert scale from 1-5, with 1 as Strongly Disagree and 5 is Strongly Agree to the question, I am strongly committed to pursuing my step count goal. A negative change value indicates lower goal commitment."|change from four months and twelve months from enrollment|This measure was only assessed on the Intervention group, and only 146 participants answered the question at either time points.||units on a scale||95% Confidence Interval|Mean
815850|NCT01102777|Secondary|Change in Average Daily Step Counts|Change in daily step counts compared to baseline and those captured in the final two weeks of the intervention and the two weeks post intervention.|baseline and final two weeks of the intervention and the two weeks post intervention.|One Intervention participant was dropped from analysis due to being an extreme outlier.||steps||95% Confidence Interval|Mean
815851|NCT01102777|Secondary|Days of Hospitalization|Number of days of all-cause hospitalization during study participation.|during study participation, up to 12 months|||days|||Number
815852|NCT01102777|Secondary|Self Reported Dyspnea|"Change in Self Reported Dyspnea from Baseline to 12 months. (Scores range from 0 to 4, with higher scores indicating more shortness of breath. For example, 0 - I only get breathless with strenuous exercise. and 4 - I am too breathless to leave the house or I am breathless when dressing.)"|twelve months from randomization|One Intervention participant was dropped from analysis due to being an extreme outlier. Nine Control and seventeen Intervention participants were missing data at 12 months.||units on a scale||Standard Deviation|Mean
815853|NCT01102777|Secondary|Self Reported Dyspnea|"Change in Self Reported Dyspnea from Baseline to 4 months. (Scores range from 0 to 4, with higher scores indicating more shortness of breath. For example, 0 - I only get breathless with strenuous exercise. and 4 - I am too breathless to leave the house or I am breathless when dressing.)"|four months from randomization|One Intervention participant was dropped from analysis due to being an extreme outlier. Three Control and ten Intervention were missing values at 4 months.||units on a scale||Standard Deviation|Mean
815854|NCT01102777|Primary|Self-Reported Respiratory-Specific Quality of Life|Change in St. George’s Respiratory Questionnaire (SGRQ) Total Score from Baseline to twelve months. (Scores range from 0 to 100, with higher scores indicating more limitations.)|twelve months from randomization|One Intervention participant was dropped from analysis due to being an extreme outlier.||units on a scale||95% Confidence Interval|Mean
815855|NCT01102777|Primary|Self-Reported Respiratory-Specific Quality of Life|Change in St. George’s Respiratory Questionnaire (SGRQ) Total Score from Baseline to four months. (Scores range from 0 to 100, with higher scores indicating more limitations.)|four months from randomization|One Intervention participant was dropped from analysis due to being an extreme outlier. In addition, not all participants had complete SGRQ data at both time points for analysis.||units on a scale||Standard Deviation|Mean
815856|NCT01102803|Secondary|Behavioral Avoidance Test (BAT)|During the initial screen, at post-treatment, and at follow-up, participants underwent a behavioral avoidance test in the virtual reality height environment. Participants reported on a 0–100 scale (100 being the most intense fear) their SUDS for floors 1, 2, 3, 4, 9, 19 of the virtual glass elevator and balconies. This test has been used successfully as a measure of treatment gains in previous studies of acrophobia research (Ressler et al., 2004). For the outcome analyses, we included the level of fear reported at the highest floor of the virtual elevator environment (19th floor). Higher scores indicate a worse outcome.|2 months|||units on a scale||Standard Deviation|Mean
815857|NCT01102803|Secondary|Clinical Global Improvement Scale (CGI)|Clinician-rated measure of improvement in acrophobia symptoms and severity. Will be assessed at each visit throughout the 2 month protocol. The CGI-S and CGI-I are widely used measures of global psychopathology severity and improvement initially developed for the study of psychotropic drugs (Guy, 1970). In order to obtain CGI ratings, the therapists (blind to study condition) interviewed the participant and used the SCID (including the specific phobia module) as well as the additional measures of acrophobia symptoms (BAT, AAQ, AAVQ, and ATHQ). In the current study, response was defined as either “very much improved” or “much improved” on CGI-I (score ≤ 2). Remission was defined as either “normal” or “minimally ill” on CGI-S (score ≤ 2). The minimum rating is a 1 and the highest is a 7. Lower scores indicate a better outcome.|2 months|||units on a scale||Standard Deviation|Mean
815858|NCT01102803|Secondary|Attitudes Towards Heights Questionnaire (ATHQ)|Self-report measures that assesses thoughts and feelings towards heights situations. This questionnaire (Abelson and Curtis, 1989) includes six heights situations and assesses attitudes toward these situations using a 0–10 scale. Higher scores indicate a worse outcome and total scores are summed over subscales. Will be assessed at each visit throughout the 2 month protocol. The minimum score is a 0; the maximum is a 60.|2 months|||units on a scale||Standard Deviation|Mean
815859|NCT01102803|Primary|Acrophobia Questionnaire With Avoidance (AAVQ)|Self-report measure that assesses fear and avoidance of a variety of heights situations. This questionnaire (Cohen, 1977) describes 20 situations and assesses levels of avoidance (0–3) and anxiety (0–6). These scales widely used measure of acrophobia with adequate retest reliability (r = .82–.86) and validity (Baker et al., 1973). Higher scores indicate higher levels of avoidance/anxiety (i.e., worse outcome). All subscales are summed for a total score. AAVQ will be assessed at each visit throughout the 2 month protocol. The minimum score is 0, the maximum is 90.|2 months|||units on a scale||Standard Deviation|Mean
815860|NCT01102894|Secondary|Food Intake Diary|Total dietary fiber consumed.|Day 1|Day 1 of each treatment subjects completed a 24 hour food record to determine baseline dietary fiber intake||g||Standard Deviation|Mean
815861|NCT01102894|Secondary|Gastrointestinal Tolerance|Subjects scored their gastrointestinal tolerance based on 7 questions on a 0-10 scale on day 4 of each treatment period and the sum score was reported. 0 being the best and 10 being the worst. Each question has a value of 1-10 for a total of 70 points as value.|Day 4|Each participant completed a gastrointestinal tolerance questionnaire during each treatment period.||units on a scale||Standard Deviation|Mean
815862|NCT01102894|Primary|Whole Gut Transit Time|The time required for the SmartPill to travel through the entire gastrointestinal tract and be present in the feces.|5 days|All participants had their transit time assessed.||hours||Standard Deviation|Mean
815946|NCT01103479|Primary|Colorectal Cancer (CRC) Screening Completion|CRC screening completion via FOBT, FIT or Colonoscopy|within 6 months of provider recommendation|||participants|||Number
832415|NCT01255423|Primary|Pain on Movement|"Pain on movement at 72 hours assessed on a 100 mm visual analog scale with anchors at 0= No pain and 100= Extreme pain"|72 hours|||mm||Standard Deviation|Mean
815863|NCT01102972|Secondary|Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group|The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 is a descriptive terminology that can be utilized for AE reporting. A grading (severity) scale is provided for each AE. Grade refers to the severity of the adverse event (AE). The CTCAE v3.0 displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1, mild AE; Grade 2, moderate AE; Grade 3, severe AE; Grade 4, life-threatening or disabling AE; Grade 5, death related to the AE.|From Baseline to Week 48|Safety Population||participants|||Number
815864|NCT01102972|Secondary|Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group|The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 is a descriptive terminology that can be utilized for AE reporting. A grading (severity) scale is provided for each AE. Grade refers to the severity of the adverse event (AE). The CTCAE v3.0 displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1, mild AE; Grade 2, moderate AE; Grade 3, severe AE; Grade 4, life-threatening or disabling AE; Grade 5, death related to the AE.|From Baseline to Week 24|Safety Population||participants|||Number
815865|NCT01102972|Secondary|Number of Confirmed Virologic Failure Participants (PAR) From Baseline Through Week 48 With the Indicated Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Tenofovir, Emtricitabine, Atazanavir, or Ritonavir|A blood sample was drawn for participants failing to respond to therapy, and changes in drug susceptibility for HIV isolated from the participants for each drug used in the study were assessed. For each participant, the changes in drug susceptibility detected by phenotypic assay in virus from the sample collected at the time of failure was compared with drug susceptibility in the virus from the blood sample at Baseline.|From Baseline to Week 48|ITT-E Population. Only those participants who met the confirmed VF criteria with viral phenotype obtained at the time of virologic failure were assessed.||participants|||Number
815866|NCT01102972|Secondary|Number of Confirmed Virologic Failure Participants (PAR) From Baseline Through Week 24 With the Indicated Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Tenofovir, Emtricitabine, Atazanavir, or Ritonavir|A blood sample was drawn for participants failing to respond to therapy, and changes in drug susceptibility for HIV isolated from the participants for each drug used in the study were assessed. For each participant, the changes in drug susceptibility detected by phenotypic assay in virus from the sample collected at the time of failure was compared with drug susceptibility in the virus from the blood sample at Baseline.|From Baseline to Week 24|ITT-E Population. Only those participants who met the confirmed VF criteria with viral phenotype obtained at the time of virologic failure were assessed.||participants|||Number
815867|NCT01102972|Secondary|Number of Confirmed Virologic Failure (VF) Participants (PAR) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 48|A blood sample was drawn for particiapants with confirmed VF >=400 c/mL. For each participant, the mutations found at the time of failure were compared with any mutations found in the blood sample at Baseline. New resistance-associated viral mutations defined by the International Acquired Immunodeficiency Syndrome Society-United States of America guidelines present at the time of failure were tabulated by drug class. NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor.|From Baseline to Week 48|ITT-E Population. Only those participants who met the confirmed VF criteria and had a viral genotype obtained at the time of VF were assessed.||participants|||Number
815868|NCT01102972|Secondary|Number of Confirmed Virologic Failure (VF) Participants (PAR) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 24|A blood sample was drawn for particiapants with confirmed VF >=400 c/mL. For each participant, the mutations found at the time of failure were compared with any mutations found in the blood sample at Baseline. New resistance-associated viral mutations defined by the International Acquired Immunodeficiency Syndrome Society-United States of America guidelines present at the time of failure were tabulated by drug class. NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor.|From Baseline to Week 24|ITT-E Population. Only those participants who met the confirmed VF criteria and had a viral genotype obtained at the time of VF were assessed.||participants|||Number
815869|NCT01102972|Secondary|Number of Participants Who Experienced Death and/or Disease Progression|Death and clinical disease progression (as per CDC classification) were assessed from Baseline through Week 48. Disease progression is defined as progression from CDC Class A to B, Class A to C, or from Class B to C. AIDS CDC classifications are: Class A, Asymptomatic/lymphadenopathy/acute HIV; Class B, Symptomatic, not AIDS; Class C, AIDS indicator conditions. The CDC categorization of HIV/AIDS is based on the lowest documented CD4 cell count (Class A, >=500 cells per microliter [µl]; Class B, 200-499 cells/µl; Class C, <200 cells/µl) and on previously diagnosed HIV-related conditions.|From Baseline to Week 48|ITT-E Population||participants|||Number
815870|NCT01102972|Secondary|Number of Participants Who Met the Protocol-defined Confirmed Viral Failure Criteria Through Week 48|The number of participants that failed to remain virologically suppressed from baseline through 48 weeks on treatment was assessed. Viral failure is defined per protocol as confirmed HIV-1 RNA >=400 c/mL.|From Baseline to Week 48|ITT-E Population||participants|||Number
815871|NCT01102972|Secondary|Number of Participants Who Met the Protocol-defined Confirmed Viral Failure Criteria Through Week 24|The number of participants that failed to remain virologically suppressed through 24 weeks on treatment was assessed. Viral failure is defined per protocol as confirmed HIV-1 RNA >=400 c/mL.|From Baseline to Week 24|ITT-E Population||participants|||Number
815872|NCT01102972|Secondary|Change From Baseline in Cholesterol/HDL Ratio at Week 48|A fasting blood sample was drawn to analyze for lipids. Change from Baseline was calculated as the Week 48 value minus the Baseline value for each parameter.|Baseline and Week 48|Safety Population: all randomized participants, with the exception of those with documented evidence of not having consumed any Investigational Product. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 48 visit and had a measurement taken during that visit period.||ratio||Standard Deviation|Mean
815947|NCT01103479|Primary|Colorectal Cancer (CRC) Screening Completion|CRC screening completion via Fecal Occult Blood Test (FOBT), Fecal Immunochemical Test (FIT) or Colonoscopy|within 6 months of provider recommendation|||participants|||Number
815873|NCT01102972|Secondary|Change From Baseline in Fasting Triglycerides, Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Low-density Lipoprotein (LDL) Cholesterol at Week 48|Triglycerides, total cholesterol, HDL cholesterol, and LDL cholesterol levels were measured or calculated at Week 48. A fasting blood sample was drawn to analyze for lipids. Change from Baseline was calculated as the Week 48 value minus the Baseline value for each parameter.|Baseline and Week 48|Safety Population: all randomized participants, with the exception of those with documented evidence of not having consumed any Investigational Product. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 48 visit and had a measurement taken during that visit period.||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
815874|NCT01102972|Secondary|Change From Baseline in Cholesterol/HDL Ratio at Week 24|A Fasting blood sample was drawn to analyze for lipids. Change from Baseline was calculated as the Week 24 value minus the Baseline value.|Baseline and Week 24|Safety Population: all randomized participants, with the exception of those with documented evidence of not having consumed any Investigational Product. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 24 visit and had a measurement taken during that visit period.||ratio||Standard Deviation|Mean
815875|NCT01102972|Secondary|Change From Baseline in Fasting Triglycerides, Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Low-density Lipoprotein (LDL) Cholesterol at Week 24|Triglycerides, total cholesterol, HDL cholesterol, and LDL cholesterol levels were measured at Week 24. A Fasting blood sample was drawn to analyze for lipids. Change from Baseline was calculated as the Week 24 value minus the Baseline value for each parameter.|Baseline and Week 24|Safety Population: all randomized participants, with the exception of those with documented evidence of not having consumed any Investigational Product. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 24 visit and had a measurement taken during that visit period.||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
815876|NCT01102972|Secondary|Change From Baseline in CD4+ Cell Count at Week 48|Blood was drawn to analyze for CD4+ cell count. A CD4+ cell is a T lymphocyte that carries the CD4 antigen. Immunologic response was assessed by CD4+ counts. Change from Baseline was calculated as the Week 48 value minus the Baseline value.|Baseline and Week 48|ITT-E Population. Observed Population. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 48 visit and had a CD4+ cell count obtained during that visit period.||cells per cubic millimeter (mm^3)||Standard Deviation|Mean
815877|NCT01102972|Secondary|Change From Baseline in CD4+ Cell Count at Week 24|Blood was drawn to analyze for CD4+ cell count. A CD4+ cell is a T lymphocyte that carries the CD4 antigen. Immunologic response was assessed by CD4+ counts. Change from Baseline was calculated as the Week 24 value minus the Baseline value.|Baseline and Week 24|ITT-E Population. Observed Population. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 24 visit and had a CD4+ cell count obtained during that visit period.||cells per cubic millimeter (mm^3)||Standard Deviation|Mean
815878|NCT01102972|Secondary|Change From Baseline in HIV-1 RNA at Week 48|Change from Baseline was calculated as the Week 48 value minus the Baseline value. Blood was drawn to analyze for plasma HIV viral load.|Baseline and Week 48|ITT-E Population. Observed Population. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 48 visit and had a viral load result obtained during that visit period.||log10 copies/mL||Standard Deviation|Mean
815879|NCT01102972|Secondary|Change From Baseline in HIV-1 RNA at Week 24|Change from Baseline was calculated as the Week 24 value minus the Baseline value. Blood was drawn to analyze for plasma HIV viral load.|Baseline and Week 24|ITT-E Population. Observed Population. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 24 visit and had a viral load result obtained during that visit period.||log10 copies/mL||Standard Deviation|Mean
815880|NCT01102972|Secondary|Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 48 Visit: Observed, MD=F, and SNAPSHOT Analyses|The percentage of PAR with HIV-1 RNA virus <400 c/mL determined from blood samples drawn at Week 48 was tabulated by treatment arm with stratification by initial antiretroviral treatment using specific analysis methods.|Week 48|ITT-E Population. Analysis methods: (1) Observed: all observed data; (2) MD=F: PAR with missing data/data collected after study medication discontinuation (DC) were failures; (3) SNAPSHOT: PAR with missing data at Week 24/data collected after study medication DC/viral load >=400 c/mL were failures.||Percentage of participants|||Number
815881|NCT01102972|Secondary|Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 24 Visit: Observed, MD=F, and SNAPSHOT Analyses|The percentage of PAR with HIV-1 RNA virus <400 c/mL determined from blood samples drawn at Week 24 was tabulated by treatment arm with stratification by initial antiretroviral treatment using specific analysis methods.|Week 24|ITT-E Population. Analysis methods: (1) Observed: all observed data; (2) MD=F: PAR with missing data/data collected after study medication discontinuation (DC) were failures; (3) SNAPSHOT: PAR with missing data at Week 24/data collected after study medication DC/viral load >=400 c/mL were failures.||percentage of participants|||Number
815882|NCT01102972|Secondary|Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 48 Visit: TLOVR Analysis|The percentage of PAR with HIV-1 RNA virus <400 c/mL determined from blood samples drawn at Week 48 was tabulated by treatment arm with stratification by initial antiretroviral treatment. Per TLOVR algorithm, responders were PAR with confirmed viral load <400 c/mL who had not met any non-responder criterion. Non-responders were PAR who never achieved confirmed HIV RNA <400 c/mL, prematurely discontinued study or study medication for any reason, had confirmed rebound to at least 400 c/mL, or had an unconfirmed HIV RNA of at least 400 c/mL at the last visit.|Week 48|ITT-E Population||Percentage of participants|||Number
815893|NCT01103063|Secondary|Percentage of Participants With Trichomonas Vaginalis Infection at 36-38 Weeks of Gestation|Participants positive for Trichomonas vaginalis infection was diagnosed based on laboratory result at 36-38 weeks of gestation. A vaginal swab was collected for the laboratory test.|At 36-38 weeks of gestation|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N=Number of participants with laboratory test results at 36-38 weeks of gestation.||Percentage of participants||95% Confidence Interval|Number
815883|NCT01102972|Secondary|Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 24 Visit: TLOVR Analysis|The percentage of PAR with HIV-1 RNA virus <400 c/mL determined from blood samples drawn at Week 24 was tabulated by treatment arm with stratification by initial antiretroviral treatment. Per TLOVR algorithm, responders were PAR with confirmed viral load <400 c/mL who had not met any non-responder criterion. Non-responders were PAR who never achieved confirmed HIV RNA <400 c/mL, prematurely discontinued study or study medication for any reason, had confirmed rebound to at least 400 c/mL, or had an unconfirmed HIV RNA of at least 400 c/mL at the last visit.|Week 24|ITT-E Population. The primary analysis method was time to loss of virologic response (TLOVR) for the proportion of participants HIV-1 RNA <400 copies/mL at Week 24.||percentage of participants|||Number
815884|NCT01102972|Secondary|Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 c/mL at the Week 48 Visit: TLOVR, Observed, M/D=F, and SNAPSHOT Analyses|The percentage of PAR with HIV-1 RNA virus <50 c/mL determined from blood samples drawn at Week 48 was tabulated by treatment arm with stratification by initial antiretroviral treatment using specific analysis methods.|Week 48|ITT-E Population. Analysis methods: (1) Observed: all observed data; (2) missing or discontinuation equals failure (M/D=F): PAR with missing data/data collected after study medication discontinuation (DC) were failures; (3) SNAPSHOT: PAR with missing data at Week 24/data collected after study medication DC/viral load >=50 c/mL were failures.||Percentage of participants|||Number
815885|NCT01102972|Secondary|Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 c/mL at the Week 24 Visit: Observed, M/D=F, and SNAPSHOT Analyses|The percentage of PAR with HIV-1 RNA virus <50 c/mL determined from blood samples drawn through Week 24 was tabulated by treatment arm with stratification by initial antiretroviral treatment using specific analysis methods.|Week 24|ITT-E Population. Analysis methods: (1) Observed: all observed data; (2) missing or discontinuation equals failure (M/D=F): PAR with missing data/data collected after study medication discontinuation (DC) were failures; (3) SNAPSHOT: PAR with missing data at Week 24/data collected after study medication DC/viral load >=50 c/mL were failures.||percentage of participants|||Number
815886|NCT01102972|Primary|Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 Copies (c)/Milliliter (mL) at the Week 24 Visit: TLOVR Analysis|The percentage of PAR with HIV-1 RNA virus <50 c/mL determined from blood samples drawn at Week 24 was tabulated by treatment arm with stratification by initial antiretroviral treatment. Per TLOVR algorithm, responders were PAR with confirmed viral load <50 c/mL who had not met any non-responder criterion. Non-responders were PAR who never achieved confirmed HIV RNA <50 c/mL, prematurely discontinued study or study medication for any reason, had confirmed rebound to at least 50 c/mL, or had an unconfirmed HIV RNA of at least 50 c/mL at the last visit.|Week 24|Intent-to-Treat (ITT)-Exposed Population: all participants exposed to at least one dose of study medication. The primary analysis method was time to loss of virologic response (TLOVR) for the proportion of participants HIV-1 RNA <50 copies/mL at Week 24.||percentage of participants|||Number
815887|NCT01103063|Secondary|Nasopharyngeal Swabs Positive for Penicillin Resistant Streptococcus Pneumoniae|This outcome measure evaluated the Streptococcus pneumoniae sensitivity against penicillin antibiotics.|Visits 6 and 7|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N=Number of participant with nasopharyngeal swabs isolating Streptococcus pneumoniae at the specified visit.||Percentage of participants|||Number
815888|NCT01103063|Secondary|Nasopharyngeal Swabs Positive for Macrolide Resistant Streptococcus Pneumoniae|This outcome measure evaluated the Streptococcus pneumoniae sensitivity against macrolide antibiotics.|Visits 6 and 7|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N=Number of participant with nasopharyngeal swabs isolating Streptococcus pneumoniae at the specified visit.||Percentage of participants|||Number
815889|NCT01103063|Secondary|Percentage of Participants With Pre-eclampsia From Week 20 to Delivery|Pre-eclampsia was diagnosed as systolic blood pressure of at least 140 mmHg and/or diastolic blood pressure of at least 90 mmHg on two separate readings taken at least 4 hours apart and proteinuria at least 300 mg protein in a 24 hour urine collection.|From Week 20 to approximately 40 weeks of gestational age|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N= Number of participants with available data.||Percentage of participants||95% Confidence Interval|Number
815890|NCT01103063|Secondary|Percentage of Participants With Bacterial Infections Including Pneumonia and Other Lower Respiratory Tract Infections From First Dose to Delivery|Participants positive for bacterial infections including other lower respiratory tract infections were measured anytime from first dose administration to delivery.|Up to approximately 40 weeks of gestational age|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N=Number of participants with available data.||Percentage of participants||95% Confidence Interval|Number
815891|NCT01103063|Secondary|Percentage of Neonates With Ophthalmia Neonatorum at Birth Period|Ophthalmia neonatorum was diagnosed at birth. The laboratory diagnosis was performed among neonates with purulent discharge.|Approximately 40 weeks of gestational age|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N=Total live births.||Percentage of neonates||95% Confidence Interval|Number
815892|NCT01103063|Secondary|Percentage of Participants With Bacterial Vaginosis Infection at 36-38 Weeks of Gestation.|Bacterial vaginosis was diagnosed based on laboratory result at 36-38 weeks of gestation. A vaginal swab was collected for the Gram staining.|At 36-38 weeks of gestation|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N=Number of participants with laboratory test results at 36-38 weeks of gestation.||Percentage of participants||95% Confidence Interval|Number
815948|NCT01103492|Primary|Number of Participants With Adverse Events|As this is a feasibility trial, the plan is to evaluate safety and efficacy in relation to adverse events in a small population (20 max) of patients.|1 year|There was no analysis of the data. Feasibility study with only one subject enrolled||partipants|||Number
815894|NCT01103063|Secondary|Percentage of Participants With Treponema Pallidum Infection at 36-38 Weeks of Gestation|Participants positive for Treponema pallidum infection was diagnosed based on laboratory result at 36-38 weeks of gestation. Treponema Pallidum particle Agglutination Assay was used.|At 36-38 weeks of gestation|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N=Number of participants with laboratory test results at 36-38 weeks of gestation.||Percentage of participants||95% Confidence Interval|Number
815895|NCT01103063|Secondary|Percentage of Participants With Neisseria Gonorrhoeae Infection at 36-38 Weeks of Gestation|Participants positive for Neisseria gonorrhoeae infection was diagnosed based on laboratory result at 36-38 weeks of gestation. A vaginal swab was collected and PCR assay was used for analysis.|At 36-38 weeks of gestation|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N=Number of participants with laboratory test results at 36-38 weeks of gestation.||Percentage of participants||95% Confidence Interval|Number
815896|NCT01103063|Secondary|Percentage of Participants With Chlamydia Trachomatis Infection at 36-38 Weeks of Gestation|Participants positive for Chlamydia trachomatis infection was diagnosed based on laboratory result at 36-38 weeks of gestation. A vaginal swab was collected and PCR assay was used for analysis.|At 36-38 weeks of gestation|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N=Number of participants with lab test results at 36-38 weeks of gestation.||Percentage of participants||95% Confidence Interval|Number
815897|NCT01103063|Secondary|Percentage of Participants With Sexually Transmitted Infections From First Dose to 36-38 Weeks of Gestation|Sexual transmitted disease included Treponema pallidum, Neisseria gonorrhoeae, and Chlamydia trachomatis infections. This was diagnosed based on clinical presentation prior to Week 36-38 and/or lab test results between Week 36-38.|Upto 36-38 weeks of gestation|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus.||Percentage of participants||95% Confidence Interval|Number
815898|NCT01103063|Secondary|Percentage of Participants With Cord Blood Parasitemia at Delivery|This outcome measure evaluated the percentage of participants positive for cord blood parasitemia at delivery. A participant was positive for parasitemia if the number of asexual parasites per μL was >0.|Approximately 40 weeks of gestational age|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N = Number of participants with cord blood smear parasite counts at delivery.||Percentage of participants||95% Confidence Interval|Number
815899|NCT01103063|Secondary|Percentage of Participants With Peripheral Parasitemia at Delivery|This outcome measure evaluated the percentage of participants positive for peripheral parasitemia at delivery. A participant was positive for parasitemia if the number of asexual parasites per μL was >0.|Approximately 40 weeks of gestational age|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N = Number of participants with peripheral blood smear parasite counts at delivery.||Percentage of participants||95% Confidence Interval|Number
815900|NCT01103063|Secondary|Percentage of Participants With Peripheral Parasitemia at 36-38 Weeks of Gestation|This outcome measure evaluated the percentage of participants positive for peripheral parasitemia at 36-38 weeks of gestation. A participant was positive for parasitemia if the number of asexual parasites per μL was >0.|At 36-38 weeks of gestation|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N = Number of participants with peripheral blood smear parasite counts at 36-38 weeks of gestation.||Percentage of participants||95% Confidence Interval|Number
815901|NCT01103063|Secondary|Percentage of Participants Requiring Additional Treatment for Symptomatic Malaria From First Dose to Delivery|This outcome measure evaluated the participants requiring additional treatments for malaria during the study period following the first dose (diagnosed based on clinical presentation and/or lab test results).|Approximately 40 weeks of gestational age|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus.||Percentage of participants||95% Confidence Interval|Number
815902|NCT01103063|Secondary|Number of Episodes of Symptomatic Malaria Per Participant From First Intermittent Preventive Treatment of Falciparum Dose to Delivery|This outcome measure determined if an episode of malaria started within the time period of first dose to delivery. Clinical episode of malaria was determined if the participant presented with clinical symptoms of malaria (fever >37.5°C, oral) and diagnosed (either by rapid diagnostic tests or microscopy) with malaria.|Approximately 40 weeks of gestational age|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus.||Number of episodes||95% Confidence Interval|Least Squares Mean
815903|NCT01103063|Secondary|Birth Weight of Live Borne Neonate|Birth weight of live borne neonates were calculated in grams.|Approximately 40 weeks of gestational age.|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus. N=Number of live births with available data.||grams||95% Confidence Interval|Least Squares Mean
815904|NCT01103063|Secondary|Percentage of Perinatal or Neonatal Deaths|Percentage of perinatal or neonatal deaths were noted.|Day 28 after delivery.|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus. N=Number of total live births.||Percentage of neonates||95% Confidence Interval|Number
816219|NCT01100853|Secondary|Amphetamine Craving Scale|The Amphetamine Craving Scale is a visual analogue scale, which is scored by indicating the level of craving on a 100 mm line, where 0 is no craving at all and 100 is the highest level of craving experienced. Scores are derived from measuring their placement on the line, yielding scores from 0 to 100.|24 weeks|||VAS Score||Standard Deviation|Mean
815906|NCT01103063|Secondary|Change From Baseline to 36-38 Weeks of Gestation in Hb Concentration.|Change from Baseline to 36-38 weeks of gestation in Hb concentration was noted.|Baseline, at 36-38 weeks of gestation.|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus. N=Number of participants with available data.||g/dL||95% Confidence Interval|Least Squares Mean
815907|NCT01103063|Secondary|Percentage of Participants With Sub-optimal Pregnancy Outcome Including Neonatal Death and Congenital Malformation|Sub-optimal pregnancy outcome including neonatal deaths and congenital malformations, defined as any of the following: live-borne neonate (singleton) with low birth-weight (or LBW for short, defined as live birth weight <2,500g), premature birth (<37 weeks), abortion (≤28 weeks), still birth (>28 weeks), neonatal death, congenital malformation, lost to follow-up prior to termination of pregnancy or delivery, or missing birth weight of the neonates.|Approximately 40 weeks of gestational age.|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus. N=Total Outcomes.||Percentage of participants||95% Confidence Interval|Number
815908|NCT01103063|Secondary|Sexually Transmitted Infection (STI) Episodes Per Participant|Number of episodes of sexually transmitted infection episodes per participant were noted. The STI's including Treponema pallidum, Neisseria gonorrhoeae, Chlamydia trachomatis, from first dose to delivery (diagnosis was based on clinical presentation and lab results).|Approximately 40 weeks of gestational age .|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus. N=Number of participants with available data.||Number of episodes||95% Confidence Interval|Least Squares Mean
815909|NCT01103063|Secondary|Percentage of Participants With Placental Malaria at Delivery Based on Histology|Participants positive for placental malaria at delivery were evaluated based on placental histology.|Approximately 40 weeks of gestational age|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus. N=Number of participants with a histology parasite evaluation at delivery.||Percentage of participants||95% Confidence Interval|Number
815910|NCT01103063|Secondary|Percentage of Participants With Placental Parasitemia at Delivery|Participants with placental parasitemia at delivery were diagnosed using Placental blood smear at birth from participants who deliver at hospital.|Approximately 40 weeks of gestational age|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus. N=Number of participants with placental parasite counts at delivery.||Percentage of participants||95% Confidence Interval|Number
815911|NCT01103063|Secondary|Percentage of Participants With Maternal Anemia (Hb <11 g/dL) at 36-38 Weeks of Gestation|Anemia was defined as Hb <11 g/dL.|At 36-38 weeks of gestation.|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus. N=Number of participants with Hb measurement at 36-38 weeks gestation.||Percentage of Participants||95% Confidence Interval|Number
815912|NCT01103063|Secondary|Percentage of Participants With Severe Maternal Anemia (Hemoglobin [Hb] <8 g/dL) at 36-38 Weeks of Gestation|Severe maternal anemia was defined as Hb <8 g/dL.|At 36-38 weeks of gestation.|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus. N=Number of participants with Hb measurement at 36-38 weeks gestation.||Percentage of participants||95% Confidence Interval|Number
815913|NCT01103063|Secondary|Percentage of Neonates With LBW (<2500 g) in Efficacy Analyzable PP Population|LBW was defined as live birth weight <2500 g (up to and including 2499 g).|Approximately 40 weeks of gestational age|Subset of ITT participants: outcome or withdrawal occurred on or before 8/27/2013 (date of study termination), compliant with study medication, birth weight measured on or before 7 days after birth if not already a failure, and did not switch to standard of care. N=Total Live Births.||Percentage of neonates||95% Confidence Interval|Number
815914|NCT01103063|Secondary|Percentage of Neonates With LBW (<2500 g) in ITT Population|LBW was defined as live birth weight <2500 g (up to and including 2499 g).|Approximately 40 weeks of gestational age|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus. N=Total live births.||Percentage of neonates||95% Confidence Interval|Number
815915|NCT01103063|Secondary|Percentage of Participants With Sub-optimal Pregnancy Outcome in Efficacy Analyzable Per Protocol (PP) Population|Adverse pregnancy outcomes were defined as live-borne neonate (singleton) with LBW (<2,500g), premature births (<37 weeks as confirmed by the Ballard score), abortion (≤28 weeks), still birth (>28 weeks), lost to follow-up prior to termination of pregnancy or delivery, or missing birth weight of the neonates.|Approximately 40 weeks of gestational age|Subset of ITT participants: outcome or withdrawal occurred on or before 8/27/2013 (date of study termination), compliant with study medication, birth weight measured on or before 7 days after birth if not already a failure, and did not switch to standard of care.||Percentage of Participants||95% Confidence Interval|Number
815916|NCT01103063|Primary|Percentage Participants With Sub-optimal Pregnancy Outcome in Intent-to-Treat (IIT) Population|Adverse pregnancy outcomes were defined as live-borne neonate (singleton) with low birth weight (LBW) (<2,500 g), premature births (<37 weeks as confirmed by the Ballard score), abortion (≤28 weeks), still birth (>28 weeks), lost to follow-up prior to termination of pregnancy or delivery, or missing birth weight of the neonates.|Approximately 40 weeks of gestational age|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus.||Percentage of participants||95% Confidence Interval|Number
815949|NCT01097915|Secondary|Taste Perception of Sweet, Sour, Salty, Bitter and Umami and Changes Due to L-Arginine Supplementation, as a Functin of Genetic Ability to Taste PROP.|Taste perception was assessed by testing the ability to recognize, and the responsiveness to, representative solutions of the five taste qualities, also when supplemented with L-Arg, in subjects classified as PROP-tasters.|8 months||12/2017||||
815917|NCT01103141|Primary|Major Peripheral Vascular Events|Major peripheral vascular events occurring during femoral catheterization followed by Percutaneous Coronary Intervention (PCI), which include any of the following: Groin bleeding, including oozing or spurting after standard compression time necessitating further compression; Groin hematoma ≥ 5 cm at any time during or after the procedure; Pseudoaneurysm, confirmed by Doppler ultrasound; Arteriovenous (AV) fistula, confirmed by Doppler ultrasound; Arterial dissection, thrombosis, or embolism; Retroperitoneal bleeding defined by Computed Tomography Angiography (CTA) or surgery; Significant drop in hemoglobin ≥ 3 g/dL, or a drop in hematocrit ≥ 10% within 24-48 hours after the procedure compared to baseline without an obvious non-groin source; Any groin complication delaying hospital discharge; Large ecchymosis (> 15 cm) at the site of vascular access on follow-up (dark purple to black and confluent ecchymoses); Obvious extravascular extravasation of contrast as noted on the femoral|7 - 14 days|||participants|||Number
815918|NCT01103232|Primary|Changes in Muscle Strength in the Contralateral Untrained Wrist Muscles|Isokinetic torque was measured in the contralateral untrained wrist muscles with the Cybex (Humac 2004/Norm) extremity-testing system before and after experiment.|6 weeks (The change calculated as 6 months minus baseline)|||Newton meters||Standard Deviation|Mean
815919|NCT01103271|Secondary|Pre-Post Efficacy|The magnitude of the pre-post effect across 4 weeks of treatment, as measured by the Hamilton Rating Scale for Depression-17 (HAMD-17). The HAMD-17 measures depression severity, and has a minimum value of 0 and a maximum value of 52 units on a scale, where higher scores indicate more severe depression.|Screen and 4 weeks (immediate treatment); Baseline and 4 weeks (waitlist treatment)|||units on a scale||Standard Deviation|Mean
815920|NCT01103271|Primary|Feasibility|The primary outcome measure is feasibility, which was operationalized as the number of in-person screens for this study.|One year|The number of participants analyzed is the number of participants screened.||screens|||Number
815921|NCT01103284|Secondary|Mean Number of Days With at Least One Hypoglycemic Event||Baseline to 25 months|Full Analysis Set (FAS) All subjects randomized who had a baseline visit and at least one scheduled post-baseline visit||days||Standard Error|Mean
815922|NCT01103284|Secondary|Frequency of Hypoglycemic Events|Total number of days with at least one hypoglycemic event recorded|Baseline to 25 Months|Full Analysis Set (FAS) All subjects randomized who had a baseline visit and at least one scheduled post-baseline visit||days|||Number
815923|NCT01103284|Other Pre-specified|Percentage of Subjects Requiring a Daily Insulin Dose ≤ 0.5 IU/kg at End of Study|Percentage of subjects requiring a daily insulin dose ≤ 0.5 IU/kg at end of study (25 Months). If insulin dose was missing at Month 25, but the Month 24 value was available, then the Month 24 value was used to calculate the percentage of subjects with a daily insulin dose ≤ 0.5 IU/kg at study end.|24 and 25 months|Full Analysis Set (FAS) All subjects randomized who had a baseline visit and at least one scheduled post-baseline visit.||percentage of subjects||95% Confidence Interval|Number
815924|NCT01103284|Secondary|Percentage of Subjects That Achieve Good Glycemic Control: HbA1c<7%|The percentage of subjects achieving good glycemic control, i.e. an HbA1c <7% at study end (Month 25). If HbA1c was missing at Month 25, but the Month 24 value was available, then the Month 24 value was used to calculate the percentage of subjects with an HbA1c ≤ 7% at study end.|24 and 25 months|Full Analysis Set (FAS) All subjects randomized who had a baseline visit and at least one scheduled post-baseline visit.||percentage of subjects||95% Confidence Interval|Number
815925|NCT01103284|Primary|Change From Baseline in Glucagon-Stimulated C-Peptide AUC at 24 Months|Change in Beta-cell function, measured as stimulated C-peptide secretion 0, 2, 6, 10 and 20 minutes post administration [area under the curve (AUC), 0-20 minutes] at baseline and 24 months, during a glucagon stimulation test (GST). The change in AUC was calculated per patient by subtracting the baseline AUC from the 24 month AUC.|Baseline and 24 months|Full Analysis Set (FAS) All subjects randomized who had a baseline visit and at least one scheduled post-baseline visit||nmol*min/L||Standard Error|Mean
815926|NCT01103323|Secondary|Tumor Response|A tumor response (best overall response) was defined for all patients, using the RECIST criteria, version 1.1. Categories: complete response (CR, tumor disappears), partial response (PR, sum of lesion sizes decreased at least 30% from baseline), stable disease (SD, steady state of disease), progressive disease (PD, sum of lesion sizes increased at least 20% from smallest sum on study or new lesions). Clinical PD considered when radiographic imaging not possible.|From randomization of the first subject until the database cut-off approximately 14 months later (19May2010 - 21Jul2011) used for 2nd planned formal interim analysis. Tumor assessed at 8 week intervals.|ITT||Percentage of participants|||Number
815927|NCT01103323|Secondary|Disease Control|Disease control was defined as the percentage of patients whose best response was not PD [sum of lesion sizes increased at least 20% from smallest sum on study or new lesions] (ie, CR [tumor disappears], PR [sum of lesion sizes decreased at least 30% from baseline] or SD (stable disease)). SD included if at least 6 weeks after randomization.|From randomization of the first subject until the database cut-off approximately 14 months later (19May2010 - 21Jul2011) used for 2nd planned formal interim analysis. Tumor assessed at 8 week intervals.|ITT||Percentage of participants|||Number
815928|NCT01103323|Secondary|Objective Tumor Response|The objective tumor response was defined as the percentage of patients with complete response (CR, tumor disappears) or partial response (PR, sum of lesion sizes decreased at least 30% from baseline) as best overall response. A best overall response was defined for all patients, using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, version 1.1. Patients whose best overall response was not CR or PR, and any patients with no post-baseline assessments were considered nonresponders for the analysis.|From randomization of the first subject until the database cut-off approximately 14 months later (19May2010 - 21Jul2011) used for 2nd planned formal interim analysis. Tumor assessed at 8 week intervals.|ITT||Percentage of participants|||Number
815929|NCT01103323|Secondary|Progression-free Survival (Based on Investigator’s Assessment)|Progression-free survival was defined as the time (days) from date of randomization to date of first observed disease progression (radiological or clinical) or death due to any cause, if death occurred before progression was documented.|From randomization of the first subject until the database cut-off approximately 14 months later (19May2010 - 21Jul2011) used for 2nd planned formal interim analysis. Tumor assessed at 8 week intervals.|ITT||Days||95% Confidence Interval|Median
815950|NCT01097915|Secondary|Association Between PROP Sensitivity and BMI|Since individual ability to taste PROP may be correlated with BMI, we determined BMI (kg/m^2) in subjects classified as super-taster, medium taster and non-taster.Weight (kg) and height (m) were recorded for each subject.|7 months|||Kg/m^2||Standard Error|Mean
815930|NCT01103323|Primary|Overall Survival|Overall survival (OS) was defined as the time (days) from randomization to death due to any cause. Patients alive at the time of analysis were censored at the last date known to be alive. If a patient was lost to follow-up and there was no contact after randomization, this patient was censored at Day 1.|From randomization of the first subject until the database cut-off approximately 14 months later (19May2010 - 21Jul2011) used for 2nd planned formal interim analysis (IA).|Intent to treat (ITT)||Days||95% Confidence Interval|Median
815931|NCT01103362|Primary|The Frequency of Adverse Events||A 28-week, open-label, safety, extension trial of flibanserin in premenopausal and postmenopausal women with HSDD|||percentage of patients-any adverse event|||Number
815932|NCT01103414|Secondary|Changes in LDL Particle Size Subfractions From Baseline to Week 12|Effects of 3 different doses of Mitoglitazone and pioglitazone as compared to placebo on LDL particle size profile as characterized by changes in NMR analysis of subfractions following once-daily dosing for 12 weeks|12 week|The Modified Per-Protocol Population included all ITT patients who completed the 12-week, double-blind treatment period with no major deviations from protocol procedures, without any study medication non-compliance issues based on their pharmacokinetic data, and with both baseline and post-baseline NMR analysis of lipoprotein particle subfractions.||nM||Standard Deviation|Mean
815933|NCT01103414|Secondary|Changes in HDL Particle Size Subfractions From Baseline to Week 12|Effects of 3 different doses of Mitoglitazone and pioglitazone as compared to placebo on HDL particle size profile as characterized by changes in NMR analysis of subfractions following once-daily dosing for 12 weeks|12 weeks|The Modified Per-Protocol Population included all ITT patients who completed the 12-week, double-blind treatment period with no major deviations from protocol procedures, without any study medication non-compliance issues based on their pharmacokinetic data, and with both baseline and post-baseline NMR analysis of lipoprotein particle subfractions.||nM||Standard Deviation|Mean
815934|NCT01103414|Secondary|Presence of Edema Post Baseline During 12 Weeks Active Treatment|Effects of 3 different doses of Mitoglitazone and pioglitazone as compared to placebo on presence of edema following once-daily dosing for 12 weeks|12 weeks|All randomized patients who received at least 1 dose of randomized study medication and had both a baseline and post baseline edema assessment||participants|||Number
815935|NCT01103414|Secondary|Change From Baseline in Waist Circumference at Week 12 Endpoint|Effects of 3 different doses of Mitoglitazone and pioglitazone as compared to placebo on waist circumference following once-daily dosing for 12 weeks|12 weeks|All randomized patients who received at least 1 dose of randomized study medication and had both baseline and week 12 waist circumference assessments||cm||Standard Deviation|Mean
815936|NCT01103414|Secondary|Change in Body Weight From Baseline to Week 12 Endpoint|Effects of 3 different doses of Mitoglitazone and pioglitazone as compared to placebo on body weight following once-daily dosing for 12|12 weeks|The Modified Per-Protocol Population included all per-protocol patients (all ITT patients who completed the 12-week, double-blind treatment period without any major deviations from the protocol procedures) without any study medication non-compliance issues based on their pharmacokinetic data.||kg||Standard Deviation|Least Squares Mean
815937|NCT01103414|Secondary|Change From Baseline in RBC|Change from baseline at week 12 endpoint in red blood cell concentration|12 week|All randomized patients who received at least 1 dose of randomized study medication and who had both baseline and week 12 assessments||10e-6 cells per uL||Standard Deviation|Mean
815938|NCT01103414|Secondary|Change From Baseline in Hemoglobin|Change from baseline at week 12 endpoint in hemoglobin concentration|12 weeks|All randomized patients who received at least 1 dose of randomized study medication and who had both baseline and week 12 assessments.||g/dL||Standard Deviation|Mean
815939|NCT01103414|Secondary|Change From Baseline to Week 12 Endpoint in Hematocrit|Change from baseline to week 12 endpoint in hematocrit as an indication of fluid retention|12 weeks|The Modified Per-Protocol Population included all per-protocol patients (all ITT patients who completed the 12-week, double-blind treatment period without any major deviations from the protocol procedures) without any study medication non-compliance issues based on their pharmacokinetic data.||percentage of volume||Standard Error|Least Squares Mean
815940|NCT01103414|Secondary|Percent Change From Baseline to Week 12 Endpoint in HMW Adiponectin|Percent change from baseline to week 12 endpoint in high molecular weight adiponectin|12 weeks|The Modified Per-Protocol Population included all per-protocol patients (all ITT patients who completed the 12-week, double-blind treatment period without any major deviations from the protocol procedures) without any study medication non-compliance issues based on their pharmacokinetic data.||percentage of baseline values||Standard Deviation|Least Squares Mean
815941|NCT01103414|Secondary|Change From Baseline in HbA1c|Change from baseline in plasma glucose measured by hemoglobin A1c in response to three different doses of Mitoglitazone and pioglitazone as compared to placebo following once-daily dosing for 84 consecutive days (12 weeks) in patients with Type 2 diabetes.|12 weeks|The Modified Per-Protocol Population included all per-protocol patients (all ITT patients who completed the 12-week, double-blind treatment period without any major deviations from the protocol procedures) without any study medication non-compliance issues based on their pharmacokinetic data.||percentage of hemoglobin||Standard Deviation|Least Squares Mean
815942|NCT01103414|Primary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12.|Change from baseline in fasting plasma glucose in response to three different doses of Mitoglitazone as compared to pioglitazone following once-daily dosing for 84 consecutive days (12 weeks) in patients with Type 2 diabetes.|Baseline, Week 12|The Modified Per-Protocol Population included all per-protocol patients (all ITT patients who completed the 12-week, double-blind treatment period without any major deviations from the protocol procedures) without any study medication non-compliance issues based on their pharmacokinetic data.||mg/dL||Standard Error|Least Squares Mean
815943|NCT01103466|Primary|Leakage Under the Base Plate|"Area of leakage under the base plate is recorded on a circular scale going from 0 fields to 24 fields where 0 is no leakage and 24 is complete leakage under the base plate."|At every change of base plate|ITT||units on a scale||Standard Deviation|Mean
815944|NCT01103479|Secondary|Provider Recommendation of CRC Screening|Provider recommendation of CRC Screening based on chart review|6 months following patient enrollment into study|||participants|||Number
815945|NCT01103479|Secondary|Provider Recommendation of CRC Screening|Provider recommendation of CRC Screening based on chart review|6 months following patient enrollment into study|||participants|||Number
815951|NCT01097915|Secondary|Electrophysiological Recordings From the Tongue for the Objective Evaluation of Individual Variations of 6-n-propylthiouracil (PROP) Sensitivity|electrophysiological recordings from the tongue of 43 subjects classified for their taste sensitivity to 6-n- propyltiouracil (PROP) and genotyped for the specific receptor gene, TAS2R38. Density of fungiform papillae was also determined in each subject. The biopotentials were recorded by means of differential electrophysiological derivations between two silver electrodes, one in contact with the ventral surface of the tongue and one in perfect adhesion with the dorsal surface.|1 year||06/2017||||
815952|NCT01097915|Secondary|Association Between PROP Sensitivity and Saliva Zinc Ion Concentration|Since the enzymatic function of gustin (CA6) depends upon the presence of Zn at its active site we measured the salivary zinc ion concentration in subjects classified as super-taster, medium taster and non-taster.The salivary Zn2+ concentration was measured with a QuantiChromTM zinc Assay kit (Gentaur, Brussels, Belgium) where the color intensity is directly proportional to the Zn2+ concentration in the sample.|7 months|||microg/dl||Standard Error|Mean
815953|NCT01097915|Primary|Association Between Gustin Gene Polymorphism and PROP Sensitivity|"We examine associations between PROP status and the polymorphism rs2274333 (A/G) of the gene that codify for the salivary protein, gustin/CA6, Which has been suggested as a trophic factor that promotes growth and development of taste buds by acting on taste bud stem cells.
The intensity of taste perception evoked by PROP and NaCl solutions was estimated to evaluate PROP taster status and molecular analysis of the gustin gene polymorphism was performed in individuals classified by PROP status using PCR techniques."|7 months|||percentage of participants|||Number
815954|NCT01103713|Other Pre-specified|Summary of Plasma Desethylchloroquine Concentration Versus Time|CQ concentrations in the plasma were determined at specified time points as PK endpoints|"Planned time: 0 (Day 0), 48 (Day 2), 50 (Day 2), 56 (Day 2), 168 (Day 7), 336 (Day 14), 504 (Day 21) and 672 (Day 28) post first dose. Note: Assuming hour not specified as 0 hours on Days 7, 14, 21 and 28 for planned time post first dose calculation."|Analyses population included all participants who received at least one dose of study medication and had at least one blood sample collected for PK analysis.||ng/ml||Standard Deviation|Mean
815955|NCT01103713|Other Pre-specified|Summary of Plasma Chloroquine Concentration Versus Time|CQ concentrations in the plasma were determined at specified time points as PK endpoints|"Planned time: 0 (Day 0), 48 (Day 2), 50 (Day 2), 56 (Day 2), 168 (Day 7), 336 (Day 14), 504 (Day 21) and 672 (Day 28) post first dose. Note: Assuming hour not specified as 0 hours on Days 7, 14, 21 and 28 for planned time post first dose calculation."|Analyses population included all participants who received at least one dose of study medication and had at least one blood sample collected for PK analysis.||ng/ml||Standard Deviation|Mean
815956|NCT01103713|Other Pre-specified|Summary of Serum Azithromycin Concentration Versus Time|AZ concentrations in the serum was determined at specified time points as PK endpoints|"Planned time: 0 (Day 0), 48 (Day 2), 50 (Day 2), 56 (Day 2), 168 (Day 7), and 336 (Day 14) hours post the first dose. Note: Assuming hour not specified as 0 hours on Day 7 and Day 14 for planned time post first dose calculation."|Analyses population included all participants who received at least one dose of study medication and had at least one blood sample collected for PK analysis.||ng/ml||Standard Deviation|Mean
815957|NCT01103713|Other Pre-specified|Summary of Hemoglobin Concentration: Abnormal Hemoglobin Level|Abnormal hemoglobin level on Day 42 was measured. The hemoglobin levels were measured with HemoCueTM, via finger stick or peripheral blood collection. The reference range was 10-16g/dL. Any value <0.8 times lower limit of normal was considered clinically significant.|Day 42|The safety analysis set consists of participants who received at least one dose of study medication.||Participants|||Number
815958|NCT01103713|Other Pre-specified|Incidence of Fever Based on Oral Temperature|Oral temp was taken by the fieldworker through Day 42.|Baseline, Days 1, 2, 7, 14, 21, 28, 35, and 42|ITT is defined as all participants who received at least one dose of study medication and who had a baseline blood smear positive for Plasmodium falciparum monoinfection, asexual parasitemia. Two participants were excluded because they had protocol deviations regarding the informed consent process.||Participants|||Number
815959|NCT01103713|Other Pre-specified|Summary of Pregnancy Outcome: Outcome of Birth|All participants were followed up for EIU safety assessments following delivery or termination of pregnancy.|Following delivery or pregnancy termination|The safety analysis set consists of participants who received at least one dose of study medication. Data was available for 160 participants only.||Participants|||Number
815960|NCT01103713|Other Pre-specified|Summary of Pregnancy Outcome: Complications During Delivery?|All participants were followed up for EIU safety assessments following delivery or termination of pregnancy.|Following delivery or pregnancy termination|The safety analysis set consists of participants who received at least one dose of study medication. Data was available for 159 participants only.||Participants|||Number
815961|NCT01103713|Other Pre-specified|Summary of Pregnancy Outcome: Labor Induced?|All participants were followed up for EIU safety assessments following delivery or termination of pregnancy.|Following delivery or pregnancy termination|The safety analysis set consists of participants who received at least one dose of study medication. Data was available for 158 participants only.||Participants|||Number
815962|NCT01103713|Other Pre-specified|Summary of Pregnancy Outcome: Delivery Assisted by Trained Obstetric Personnel?|All participants were followed up for EIU safety assessments following delivery or termination of pregnancy.|Following delivery or pregnancy termination|The safety analysis set consists of participants who received at least one dose of study medication. Data was available for 159 participants only.||Participants|||Number
815963|NCT01103713|Other Pre-specified|Summary of Pregnancy Outcome: Mode of Delivery|All participants were followed up for EIU safety assessments following delivery or termination of pregnancy.|Following delivery or pregnancy termination|The safety analysis set consists of participants who received at least one dose of study medication. Data was available for 160 participants only.||Participants|||Number
815964|NCT01103713|Other Pre-specified|Summary of Pregnancy Outcome: Location of Delivery|All participants were followed up for exposure-in-utero (EIU) safety assessments following delivery or termination of pregnancy.|Following delivery or pregnancy termination|The safety analysis set consists of participants who received at least one dose of study medication. Data was available for 160 participants only.||Participants|||Number
816220|NCT01100853|Primary|Number Negative Urines (Proportion Negative Urines)||24 Weeks|Urine drug screens negative amphetamine||Urine Drug Screen|||Number
815965|NCT01103713|Secondary|Number of Asexual P. Falciparum Per Microliter of Blood at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication|Parasite counts (actual counts per microliter of blood) was measured at various time points.|Days 7, 14, 21, 28, 35, and 42|PP population was used. PP is a subset of MITT population who received all 3 days of study medication. Two participants were excluded because they had protocol deviations regarding the informed consent process.||Parasite count per microliter||Standard Error|Mean
815966|NCT01103713|Secondary|Number of Asexual P. Falciparum Per Microliter of Blood at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication|Parasite counts (actual counts per microliter of blood) was measured at various time points.|Days 7, 14, 21, 28, 35, and 42|MITT population was used. MITT is a subset of the ITT population who had Plasmodium falciparum monoinfection (confirmed by microscopy) parasite count in the range of 80-100,000/microlitre on their baseline blood smear. Two participants were excluded because they had protocol deviations regarding the informed consent process.||Parasite count per microliter||Standard Error|Mean
815967|NCT01103713|Secondary|Number of Asexual P. Falciparum Per Microliter of Blood at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication|Parasite counts (actual counts per microliter of blood) was measured at various time points.|Days 7, 14, 21, 28, 35, and 42|ITT population was used. ITT is defined as all participants who received at least one dose of study medication and had a baseline blood smear positive for Plasmodium falciparum monoinfection, asexual parasitemia. Two participants were excluded because they had protocol deviations regarding the informed consent process.||Parasite count per microliter||Standard Error|Mean
815968|NCT01103713|Secondary|Percentage of Participants With Parasitologic Response (PCR Uncorrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication|The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR uncorrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR uncorrected) through the day of consideration, otherwise she is a parasitological failure.|Days 7, 14, 21, 28, 35, and 42|ITT population was used. ITT is defined as all participants who received at least one dose of study medication and had a baseline blood smear positive for Plasmodium falciparum monoinfection, asexual parasitemia. Two participants were excluded because they had protocol deviations regarding the informed consent process.||Percentage of participants||95% Confidence Interval|Number
815969|NCT01103713|Secondary|Percentage of Participants With Parasitologic Response (PCR Uncorrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication|The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR uncorrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR uncorrected) through the day of consideration, otherwise she is a parasitological failure.|Days 7, 14, 21, 28, 35, and 42|PP population was used. PP is a subset of MITT population who received all 3 days of study medication. Two participants were excluded because they had protocol deviations regarding the informed consent process.||Percentage of participants||95% Confidence Interval|Number
815970|NCT01103713|Secondary|Percentage of Participants With Parasitologic Response (PCR Uncorrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication|The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR uncorrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR uncorrected) through the day of consideration, otherwise she is a parasitological failure.|Days 7, 14, 21, 28, 35, and 42|MITT population was used. MITT is a subset of the ITT population who had Plasmodium falciparum monoinfection (confirmed by microscopy) parasite count in the range of 80-100,000/microlitre on their baseline blood smear. Two participants were excluded because they had protocol deviations regarding the informed consent process.||Percentage of participants||95% Confidence Interval|Number
815971|NCT01103713|Secondary|Percentage of Participants With Parasitologic Response (PCR Corrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication|The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR corrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR corrected) through the day of consideration, otherwise she is a parasitological failure.|Days 7, 14, 21, 28, 35, and 42|ITT population was used. ITT is defined as all participants who received at least one dose of study medication and who had a baseline blood smear positive for Plasmodium falciparum monoinfection, asexual parasitemia. Two participants were excluded because they had protocol deviations regarding the informed consent process.||Percentage of participants||95% Confidence Interval|Number
815972|NCT01103713|Secondary|Percentage of Participants With Parasitologic Response (PCR Corrected) at Days 7, 14, 21, 35, and 42 , Post First Dose of Study Medication|The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR corrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR corrected) through the day of consideration, otherwise she is a parasitological failure.|Days 7, 14, 21, 35, and 42|PP population was used. PP is a subset of MITT population who had received all 3 days of study medication. Two participants were excluded because they had protocol deviations regarding the informed consent process.||Percentage of participants||95% Confidence Interval|Number
815973|NCT01103713|Secondary|Percentage of Participants With Parasitologic Response (PCR Corrected) at Days 7, 14, 21, 35, and 42 Post First Dose of Study Medication|The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR corrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR corrected) through the day of consideration, otherwise she is a parasitological failure.|Days 7, 14, 21, 35, and 42|MITT population was used. MITT is a subset of the ITT population who had Plasmodium falciparum monoinfection (confirmed by microscopy) parasite count in the range of 80-100,000/microlitre on their baseline blood smear. Two participants were excluded because they had protocol deviations regarding the informed consent process.||Percentage of participants||95% Confidence Interval|Number
815974|NCT01103713|Primary|Percentage of Participants With Parasitologic Response (PCR Corrected) at Day 28 Post First Dose of Study Medication|The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR corrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR corrected) through the day of consideration, otherwise she is a parasitological failure.|Day 28|PP population was used. PP is a subset of MITT population who had received all 3 days of study medication. Two participants were excluded because they had protocol deviations regarding the informed consent process.||Percentage of participants||95% Confidence Interval|Number
815975|NCT01103713|Primary|Percentage of Participants With Parasitologic Response (Polymerase Chain Reaction (PCR) Corrected) at Day 28 Post First Dose of Study Medication|The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR corrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR corrected) through the day of consideration, otherwise she is a parasitological failure.|Day 28|MITT population was used. MITT is a subset of the ITT population who had Plasmodium falciparum monoinfection (confirmed by microscopy) parasite count in the range of 80-100,000/microlitre on their baseline blood smear. Two participants were excluded because they had protocol deviations regarding the informed consent process.||Percentage of participants||95% Confidence Interval|Number
815976|NCT01104701|Secondary|Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population|Potential clinical importance (PCI): triacylglycerol lipase high values were > 3* upper limit of normal (ULN); creatinine high values in males >1.6 mg/dL, females >1.4 mg/dL; gamma glutamyl transferase (GGT) high value >3* ULN; bilirubin high value > 2 mg/dL; Urate high values > 10 (males), >8 (females) mg/dL; potassium low value < 3 milliequivalents per liter (mEq/L), high value >5.5 mEq/L; calcium low value < 8 mg/dL and high value > 11 mg/dL. Laboratory samples were obtained at baseline (Day 1 or if unavailable, last measurement prior to first study drug dose), Weeks 6, 12, 20, and at study termination (Week 24) or early termination. Number of laboratory values of potential clinical importance (values could be either low or high) are presented for Weeks 6 - Week 24 or early termination. Note: those tests with no values meeting the PCI criteria, ie, 0 values observed across all treatment arms, are not presented.|Day 1 to Study Termination (Week24) or early termination|All participants who were randomized and received at least one dose of study drug were analyzed in the intent to treat (ITT) population. n= all participants who received at least one dose of study drug and had available laboratory measurements.||laboratory values|||Number
815977|NCT01104701|Secondary|Number of Hematology Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population|Potential clinical importance are the following: Hematocrit values for males less than (<) 36%, females < 30%; hemoglobin for males <12 grams per deciliter (g/dL), females < 10 g/dL; low platelet values <75,000/micro liter (µL), high values greater than (>) 500,000 µL. Laboratory samples were obtained at baseline (Day 1 or if unavailable, last measurement prior to first study drug dose), Weeks 6, 12, 20, and at study termination (Week 24) or early termination. Number of laboratory values of potential clinical importance presented for Weeks 6 - Week 24 or early termination.|Day 1 to study termination (24 weeks) or early termination|n= all participants who received at least one dose of study drug and had available laboratory measurements.||laboratory values|||Number
815978|NCT01104701|Secondary|Participants Negative or Positive for Anti-exenatide Antibodies - ITT Population|Serum titers of antibodies to exenatide were evaluated using a validated enzyme-linked immunosorbent assay (Covance Method No. ELISA-0308). Positive antibody to exenatide titer: observed at the indicated visit following a negative or missing titer at baseline, or a positive titer that has increased by at least 3 dilutions at the indicated visit from a detectable baseline. Baseline=Day 1.|Day 1 to Study Termination (24 weeks) or early termination|n=all participants who received at least one dose of study drug and had available titer.||participants|||Number
815979|NCT01104701|Secondary|Number of Participants With Injection Site Reaction Treatment Emergent Adverse Events - ITT Population|"AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Injection site related adverse events were defined as the adverse events with 'injection site' phrase in preferred term excluding 'injection site nodule'. The following events were Injection Site Reaction AEs: erythema, hematoma, hemorrhage, site pain, site papule, site pruritus, site warmth.
Participants receiving study drug monthly received 5 injections with last injection at Week 16; Participants receiving study drug weekly received 20 injections with last injection at Week 19."|Day 1 through study termination (Week 24) or early termination.|All participants who received at least one dose of study drug were analyzed in the ITT population.||participants|||Number
815980|NCT01104701|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), and AEs Leading to Discontinuation - ITT Population|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. All participants who received at least one dose of study drug were included in the ITT analysis. Treatment-emergent (TE) adverse events were defined as those with onset at or after initiation of study medication on Day 1 through study termination or early termination.|Day 1 to Study Termination (24 Weeks) or early Termination|All participants who received at least one dose of study drug were included in the ITT analysis.||participants|||Number
815981|NCT01104701|Secondary|Mean Change From Baseline in Heart Rate at Week 20 - Intent to Treat (ITT) Population|Baseline was Day 1, or last measurement prior to first dose of study drug. Heart rate was measured after the participant had rested for approximately 5 minutes and with the participant in a sitting position. Measurement was recorded in beats per minute (bpm). The measurement was repeated after at least 30 seconds and the average of the two readings recorded. ITT population was defined as all participants who received at least one dose of the study drug.|Baseline (Day 1), Week 20|Participants who received at least one dose of study drug were analyzed in the ITT population.||bpm||Standard Deviation|Mean
816221|NCT01100931|Primary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|31.5 months|||Participants|||Number
815982|NCT01104701|Secondary|Mean Change From Baseline in Diastolic and Systolic Blood Pressure at Week 20 - Intent to Treat (ITT) Population|Baseline was Day 1, or last measurement prior to first dose of study drug. Vital signs were measured after the participant had rested for approximately 5 minutes and with the participant in a sitting position. Measurement was recorded in millimeters of mercury (mmHg). The blood pressure measurement was repeated after at least 30 seconds and the average of the two readings recorded. ITT population was defined as all participants who received at least one dose of the study drug.|Baseline (Day 1), Week 20|Participants who received at least one dose of study drug were analyzed in the Intent to Treat (ITT) population.||mmHg||Standard Deviation|Mean
815983|NCT01104701|Secondary|Time Weighted Average Concentration and Peak to Trough of Exenatide From Week 12 Through Week 16 - Pharmacokinetic Evaluable - Steady State Population|All participants received an initial blood draw prior to the first dose and a single blood sample was collected at all other subsequent visits, for plasma exenatide assessments and the characterization of pharmacokinetic (PK) parameters following multiple monthly doses over the study period. Exenatide was measured using a validated enzyme-linked immunosorbent assay (ELISA). Time weighted average concentration (Cave (2016-2688 h) and Peak to Trough were measured in picograms per milliliter (pg/mL).|Day 1 to Week 20|PK Evaluable- Steady-State: from trough to trough following Week 12 through Week 16, 3 or more values.||pg/mL||Geometric Coefficient of Variation|Geometric Mean
815984|NCT01104701|Secondary|Mean Change in Fasting Glucose From Baseline to Week 20 - Evaluable Population|Fasting glucose was measured in milligrams per deciliter (mg/dL) at screening, Baseline, and during treatment at Weeks 2, 4, 6, 8, 9-11, 12, 13, 14, 15, 16, 17-19, and 20. Baseline was Day 1, or last measurement prior to first dose of study drug. Evaluable population was defined as all participants who completed study procedures in compliance with the protocol and had adequate exposure to the study drug.|Baseline (Day 1) to Week 20|All participants who received at least one dose of study drug, complied with the protocol, had adequate study drug exposure, and had a measurement value on the specified week were included in the analysis of the evaluable population. n=number of participants with measurement value.||mg/dL||Standard Error|Mean
815985|NCT01104701|Secondary|Mean Change in Body Weight From Baseline to Week 20 - Evaluable Population|Body weight was measured in kilograms (kg) at Baseline, and during treatment at Weeks 2, 4, 6, 8, 9-11, 12, 13, 14, 15, 16, 17-19, and 20. Baseline was Day 1, or last measurement prior to first dose of study drug. Evaluable population was defined as all participants who completed study procedures in compliance with the protocol and had adequate exposure to the study drug.|Baseline (Day 1) to Week 20|All participants who received at least one dose of study drug, complied with the protocol, had adequate study drug exposure, and had a measurement value on the specified week were included in the analysis. n=number of participants with measurement value.||kg||Standard Error|Mean
815986|NCT01104701|Secondary|Percentage of Participants Achieving HbA1c Target Values at Week 20 - Evaluable Population|HbA1c was measured as a percent (%) of total hemoglobin. The Target values for HbA1c were <7% and ≤ 6.5% at Week 20. Evaluable population was defined as participants who completed study procedures in compliance with the protocol and had adequate exposure to the study drug.|Week 20|All participants who received at least one dose of study drug, complied with the protocol, had adequate study drug exposure, and had a measurement value for Week 20 were included in the analysis of the evaluable population. n=number of participants with measurement value.||percentage of Participants|||Number
815987|NCT01104701|Primary|Mean Change in HbA1c From Baseline to End of Treatment (Week 20) - Evaluable Population|HbA1c was measured as a percent of total hemoglobin at screening, Baseline, and during treatment on Weeks 4, 8, 12, 16, and 20. Baseline was Day 1, or last measurement prior to first dose of study drug. The Evaluable population was defined as participants who completed study procedures in compliance with the protocol and had adequate exposure to the study drug.|Baseline (Day 1) to 20 weeks|All participants who received at least one dose of study drug, complied with the protocol, had adequate study drug exposure, and had a measurement value on the specified week were included in the analysis of the evaluable population. n=number of participants with measurement value.||Percent of Hemoglobin||Standard Error|Mean
815988|NCT01104870|Secondary|Change in N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) Concentrations From Baseline to Week 12|The N-terminal pro-BNP (NT-proBNP) serum concentration was assessed to compare the severity of heart failure at Baseline and Week 12.|Baseline and Week 12|All subjects with Baseline and Week 12 NT-proBNP values recorded were included in the analysis.||pg/mL||Standard Deviation|Mean
815989|NCT01104870|Secondary|Number of Participants With a Change From Baseline World Health Organization (WHO) Functional Classification at Week 12|The WHO Functional Class of pulmonary hypertension is a physical activity rating scale as follows: Class I: No limitation of physical activity. Class II: Slight limitation of physical activity. Class III: Marked limitation of physical activity. Class IV: Inability to carry out any physical activity without symptoms. Only participants who experienced a change in WHO functional classification from Baseline to Week 12 are described by class change below; all other participants maintained their Baseline WHO functional classification at Week 12.|Change from Baseline at Week 12|All subjects with Baseline and Week 12 WHO functional classifications recorded were included in the analysis.||participants|||Number
815990|NCT01104870|Secondary|Change in PH Symptoms From Baseline to Week 12|Symptoms of PH including fatigue, dyspnea, edema, dizziness, syncope, chest pain and orthopnea were assessed and severity grade values (i.e., 0, 1, 2 or 3) for each symptom were assigned for subjects. A severity of 0 indicated no symptoms, the maximum severity was 3, indicating severe symptoms. Median change in symptom severity from Baseline to Week 12 is described.|Change from Baseline at 12 Weeks|All subjects with Baseline and Week 12 values recorded for symptoms of PH were included in the analysis.||units on a scale||Inter-Quartile Range|Median
815991|NCT01104870|Secondary|Change in Borg Dyspnea Score (Following 6MWT) From Baseline to Week 12|The Borg dyspnea score is a 10-point scale rating the maximum level of dyspnea (difficulty in breathing) experienced during the six-minute walk test (6MWT). The Borg dyspnea score was assessed immediately following the 6MWT. Scores ranged from 0 (for no shortness of breath) to 10 (for the greatest shortness of breath ever experienced).|Baseline and Week 12|All subjects with Baseline and Week 12 Borg dyspnea scores recorded were included in the analysis.||score||Inter-Quartile Range|Median
816489|NCT01108835|Secondary|Lung Function|Measurement of change of spirometry (FEV1 % predicted) from baseline to 12 month. The range is from 0% to 100%. The change was calculated by 12 month value minus the baseline value. Positive value indicated improvement in lung function.|12 months|Percentage of predicted FEV1||Percentage of Predicted FEV1||Standard Deviation|Mean
815992|NCT01104870|Secondary|Change in 6-minute Walk Distance (6MWD) From Baseline to Week 12|The intent of the 6MWD test is to evaluate exercise capacity associated with carrying out activities of daily living. Change in 6MWD from Baseline to Week 12, correlates with the current clinical standard for assessing patient functional status in the treatment of PH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS). Subjects were instructed to walk down a corridor at a comfortable speed as far as they could manage for six minutes. Distance <500 meters suggests considerable exercise limitation; Distance 500-800 meters suggests moderate limitation; Distance >800 meters (with no rests) suggests mild or no limitation.|Baseline and Week 12|All subjects with Baseline and Week 12 6MWD values recorded were included in the analysis.||meters||Standard Deviation|Mean
815993|NCT01104870|Secondary|Change in Cardiac Index (CI) From Baseline to Week 12|Cardiac Index (CI) relates the cardiac output (CO) from left ventricle to body surface area (BSA), thus relating heart performance to the size of the individual. The CI values and their respective changes from Baseline to Week 12 at peak exercise will be summarized by treatment group and measured by Swan-Ganz right heart catheterization.|Baseline and Week 12|All subjects with Baseline and Week 12 CI values recorded were included in the analysis.||L/min/m^2||Standard Deviation|Mean
815994|NCT01104870|Secondary|Change in Mean Pulmonary Artery Pressure (PAPm) From Baseline to Week 12|Pulmonary hypertension (PH) is an increase in pressure in the pulmonary vasculature defined as a mean pulmonary artery pressure (PAPm) greater than 25 mmHg at rest or greater than 30 mmHg with exercise, as measured by right heart catheterization. The PAPm values and their respective changes from Baseline to Week 12 at peak exercise will be summarized by treatment group and measured by Swan-Ganz right heart catheterization.|Baseline and Week 12|All subjects with Baseline and Week 12 PAPm values recorded were included in the analysis.||mmHg||Standard Deviation|Mean
815995|NCT01104870|Primary|Change in Peak Total Pulmonary Resistance Index (TPRI) During Exercise From Baseline to Week 12|"The effects of 12-week treatment with different doses of UT-15C on peak TPRI during exercise will be evaluated by comparing the change from Baseline to Week 12 at peak wattage on a pairwise basis between treatment groups.
The primary measure of efficacy was the change from Baseline to Week 12 in peak TPRI during exercise assessed 3 to 6 hours after the subject’s morning dose of UT-15C to obtain measurements at peak concentrations of treprostinil. The equation used to determine the Total Pulmonary Resistance Index (TPRI) (mmHg/[L/min/m^2]) is Mean Pulmonary Artery Pressure (PAPm)/ Cardiac Index (CI)."|Baseline and Week 12|All subjects with Baseline and Week 12 TPRI values recorded were included in the analysis.||mmHg/(L/min/m^2)||Standard Deviation|Mean
815996|NCT01105065|Secondary|Frequency Doubling Perimetry|Frequency doubling perimetry was measured pre- and post treatment with brimonidine for 8 weeks.We used the full-threshold N-30 protocol to determine the visual field mean deviation, pattern standard deviation, and test duration in the eye that had hemodynamic testing. The results that are reported below are the mean deviation values recorded as part of the frequency doubling perimetry as these are the most significant.|8 weeks|||dB||Standard Deviation|Mean
815997|NCT01105065|Primary|Presence of Retinal Blood Flow Autoregulation|We defined retinal vascular dysregulation based on the percentage change between the retinal blood flow measured while reclining for 30 minutes and the baseline seated measures. In a prior study, we found that healthy subjects exhibited a +6.5%±12% blood flow change induced by 30 minutes of reclining. Thus, we defined the normal range of blood flow autoregulation as within 2 standard deviations of the mean percentage change found in this group, or -17.5% to +30.5%.|8 weeks|||participants|||Number
815998|NCT01105091|Primary|Body Weight - Baseline and Day 28|Body weight was measured both at baseline and day 28.|Baseline and 28 days|Patients who had both baseline and Day 28 assessments were included in the analysis. The analysis was conducted without replacement of missing values.||kg||Full Range|Median
815999|NCT01105091|Primary|Heart Rate - Baseline and Day 28|Heart rate was measured indirectly using an automatic oscillometric device, on the same arm for each measurement. The Heart Rate was assessed at Baseline and at Day 28 (End of Study Treatment visit).|Baseline and 28 days|Patients who had both baseline and Day 28 assessments were included in the analysis. The analysis was conducted without replacement of missing values.||Beats per minute||Full Range|Median
816000|NCT01105091|Primary|Blood Pressure - Baseline and Day 28|Blood pressure (systolic and diastolic) were measured indirectly using an automatic oscillometric device, on the same arm for each measurement. The Blood Pressure was assessed at baseline and at Day 28 (End of Study Treatment visit).|Baseline and 28 days|Patients who had both baseline and Day 28 assessments were included in the analysis. The analysis was conducted without replacement of missing values.||mm Hg||Full Range|Median
816001|NCT01105091|Primary|Percentage Central Venous Blood Oxygen Saturation (ScVO2) - Baseline and Day 28|Central venous blood oxygen saturation assessment was performed only in specific centers. Measurements for ScVO2 were performed during the inpatient hospitalization period on Day 1 (prior to drug initiation) and on Day 28 (EOT). Samples for ScVO2 were obtained by aspirating blood from the indwelling central venous catheter. After the sample had been drawn, the catheter was primed with study drug in order to refill the lumen to avoid interruption in treatment and sudden decompensation.|Baseline and 28 days|Patients who had both baseline and Day 28 assessments were included in the analysis. The analysis was conducted without replacement of missing values.||percentage oxygen saturation||Full Range|Median
816002|NCT01105091|Primary|Patients With New York Heart Association (NYHA) Functional Class Change (Improved or Worsened) From Baseline to Day 28|Disease severity was assessed by NYHA classification of PAH criteria: Class I: no limitation of physical activity (PA). Ordinary PA: no undue dyspnea/fatigue, chest pain, near syncope. Class II: slight limitation of PA. Comfortable at rest. Ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class III: marked limitation of PA. Comfortable at rest. Less than ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class IV: inability to carry out PA without symptoms. Right heart failure. Dyspnea/fatigue may even have been present at rest. Discomfort increased by any PA.|From baseline to 28 days (+3 days)|Patients who had both baseline and Day 28 assessments were included in the analysis. The analysis was conducted without replacement of missing values.||participants|||Number
816076|NCT01106092|Secondary|Anti-D and Anti-T Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.|Prior to (At Month 0) and one month after booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.||IU/mL||95% Confidence Interval|Geometric Mean
816003|NCT01105091|Primary|Six-minute Walk Distance (6MWD) - Baseline and Day 28|The 6-minute walk test (6MWT) was to be performed prior to initiating study treatment either during the screening visit or on Day 1 prior to drug initiation, and Day 28 (End of treatment (EOT)). This assessment is a non-encouraged test that measures the distance walked for a duration of 6 minutes. The 6MWD was recorded in the Case Report Form (CRF).|Baseline and 28 days (+3 days)|Patients who had both baseline and Day 28 assessments were included in the analysis. The analysis was conducted without replacement of missing values.||meters||Full Range|Median
816004|NCT01105091|Primary|Dose Normalized Pharmacokinetics of 6-keto-Prostacyclin F1alpha at 4 ng/kg/Min|The plasma concentration for the epoprostenol metabolite 6-keto-Prostacyclin F1alpha was measured at 4 ng/kg/min just prior to the next up-titration. Dose-normalized concentrations are used to summarize the results.|Day 1|A per-protocol analysis set that included all patients in the treated set who did not violate the protocol in a way that might affect the evaluation of the effect of the study drug(s) on the pharmacokinetic endpoints.||(pg/ml)/(ng/kg/min)||Full Range|Median
816005|NCT01105091|Primary|Dose Normalized Pharmacokinetics of 6-keto-Prostacyclin F1alpha at 2 ng/kg/Min|The plasma concentration for the epoprostenol metabolite 6-keto-Prostacyclin F1alpha was measured at 2 ng/kg/min just prior to the next up-titration. Dose-normalized concentrations are used to summarize the results.|Day 1|A per-protocol analysis set that included all patients in the treated set who did not violate the protocol in a way that might affect the evaluation of the effect of the study drug(s) on the pharmacokinetic endpoints.||(pg/ml)/(ng/kg/min)||Full Range|Median
816006|NCT01105091|Primary|Dose Normalized Pharmacokinetics of 6,15-diketo-13,14-dihydro-Prostacyclin F1alpha at 4 ng/kg/Min|The plasma concentration for the epoprostenol metabolite 6,15-diketo-13,14-dihydro-Prostacyclin F1alpha was measured at 4 ng/kg/min just prior to the next up-titration. Dose-normalized concentrations are used to summarize the results.|Day 1|A per-protocol analysis set that included all patients in the treated set who did not violate the protocol in a way that might affect the evaluation of the effect of the study drug(s) on the pharmacokinetic endpoints.||(pg/ml)/(ng/kg/min)||Full Range|Median
816007|NCT01105091|Primary|Dose Normalized Pharmacokinetics of 6,15-diketo-13,14-dihydro-Prostacyclin F1alpha at 2 ng/kg/Min|The plasma concentration for the epoprostenol metabolite 6,15-diketo-13,14-dihydro-Prostacyclin F1alpha was measured at 2 ng/kg/min just prior to the next up-titration. Dose-normalized concentrations are used to summarize the results.|Day 1|A per-protocol analysis set that included all patients in the treated set who did not violate the protocol in a way that might affect the evaluation of the effect of the study drug(s) on the pharmacokinetic endpoints.||(pg/ml)/(ng/kg/min)||Full Range|Median
816008|NCT01105117|Primary|Safety and Tolerability of ACT-385781A and Flolan in Injectable Prostanoid Treatment-naïve Patients With PAH - Number of Deaths||Up to 39 days. Day 1 - until patients transition from study medication to commercially-obtained medication|Study population||participants|||Number
816009|NCT01105117|Primary|Safety and Tolerability of ACT-385781A and Flolan in Injectable Prostanoid Treatment-naïve Patients With Pulmonary Arterial Hypertension (PAH) - Number of Patients With Adverse Events Leading Discontinuation of Study Treatment||Up to 39 days. Day 1 - until patients transition from study medication to commercially-obtained medication|Study population||participants|||Number
816010|NCT01105130|Secondary|Quality of Life|Quality of life is quantified by the Functional Assessment of Cancer Therapy - Prostate (FACT_P) questionnaire. The FACT questionnaire is comprised of four subscales – social, emotional, functional, and physical. Each subscale is obtained by summing over 6-7 items, each of which is coded on a 0 to 4 scale. Negatively worded questions are reverse scored and higher scores for each subscale indicate better HRQOL. The social, functional, and physical subscales range from 0 to 28 while the emotional subscale ranges from 0 to 24. The overall score (FACT-G) is the sum over the four subscales and ranges from 0 to 108. Patients also completed 12 questions related to prostate cancer, and the prostate subscale score is the sum of those responses (with some items reverse scored). Scores range from 0 to 48, and as with the other FACT subscales higher scores indicate better HRQOL. FACT-P is the sum of FACT-G and the prostate subscale. This questionnaire was added half-way through the study.|8 weeks|All participants who completed the FACT_P at any time.||units on a scale||Standard Error|Least Squares Mean
816011|NCT01105130|Secondary|Adherence|Adherence is the percentage of prescribed pills taken by the participants|8 weeks|Participants who returned pill diaries.||percentage of prescribed pills||Full Range|Mean
816012|NCT01105130|Secondary|Retention|Retention is the percentage of participants who complete the 8 week visit.|8 weeks|All randomized participants||percentage of participants||95% Confidence Interval|Number
816013|NCT01105130|Primary|Erectile Function|The International Index of Erectile Function (IIEF) questionnaire consists of 15 questions, each of which is scored on a 0 to 5 or 1 to 5 scale. It is comprised of five domains, each scored as the sum of 2 to 5 questions. Erectile function is the sum of six questions with a range from 1 to 30. Higher scores indicate better functioning.|8 weeks|All participants providing data at any time.||units on a scale||Standard Error|Least Squares Mean
816014|NCT01105247|Secondary|Percentage of Participants Achieving Response|Response criteria are as outlined in the IWCLL 2008 criteria (Hallek 2008) and as assessed by investigator, e.g. response requires 50% reduction in lymph node size.|The median follow-up time for all treated patients are 21 month, range (0.7 month, 29 months).|||Percentage of Participants||95% Confidence Interval|Number
816015|NCT01105247|Secondary|Progression Free Survival Rate at 24 Months|Criteria for progression are as outlined in the IWCLL 2008 criteria (Hallek 2008) and as assessed by investigator, e.g. progression defined as a 50% increase in lymph node size.|The median follow-up time for all treated patients are 21 month, range (0.7 month, 29 months).|||Percentage of Participants||95% Confidence Interval|Number
816016|NCT01105247|Secondary|Food Effect Cohort Assessments|Geometric mean ratio (Fed/Fasted) for PCI-32765 AUClast. The data were collected at 0, 0.5, 1, 2, 4, 6, 24 h post-dose. The AUClast was calculated from 0 up to 24 hours post-dose.|Fed was assessed on either Day 8 or Day 15 and Fasted was assessed on the remaining day as cross-over design.|Note: 16 subjects were participated in food effect cohort. However, the PK parameters for 1 subject under Fasted treatment period cannot be reliably estimated. The data for this subject were excluded from Fed/Fasted comparison.||||90% Confidence Interval|Number
816017|NCT01105247|Primary|Number of Participants With Treatment Emergent Adverse Events (AEs)|Number of participants who had experienced at least one treatment emergent AEs.|From first dose to within 30 days of last dose of PCI-32765|||Participants|||Number
816018|NCT01105312|Secondary|Confirmed Response Rate (Phase I)|A confirmed response is defined to be a CR or PR (as determined by RECIST criteria) noted as the objective status on 2 consecutive evaluations at least 4 weeks apart. Response will be evaluated using all cycles of treatment. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response. The number of confirmed responses will be reported here.|from baseline up to 5 years|All 12 eligible phase I patients were treated and analyzed.||Participants|||Count of Participants
816019|NCT01105312|Secondary|Time to Treatment Failure|Time to treatment failure (TTF) is defined as the time from the date of registration to the date at which the patient is removed from treatment due to progression, unacceptable adverse events, or refusal. The distribution of TTF will be estimated using the method of Kaplan-Meier|from baseline up to 5 years post-registration|13 of the 16 phase II patients were eligible, treated, and analyzed.||months||95% Confidence Interval|Median
816020|NCT01105312|Secondary|Clinical Benefit Rate|Clinical benefit rate will be estimated by the total number of patients with an objective status of CR, PR, or SD for duration of at least 6 months divided by the total number of evaluable patients. All evaluable patients will be used for this analysis. Exact binomial 95% confidence intervals for the true clinical benefit rate will be calculated.|from baseline up to 6 months|13 of the 16 phase II patients were eligible, treated, and analyzed.||percentage of participants||95% Confidence Interval|Number
816021|NCT01105312|Secondary|Duration of Response (Phase II)|Duration of response is defined for all evaluable patients who have achieved a confirmed response as the date at which the patient’s objective status is first noted to be a CR or PR to the earliest date progression is documented. The distribution of duration of response will be estimated using the method of Kaplan-Meier.|from baseline up to 5 years post-registration|13 of the 16 phase II patients were treated and analyzed||months||95% Confidence Interval|Median
816022|NCT01105312|Secondary|Progression-free Survival (Phase II)|Progression-free survival (PFS) is defined as the time from registration to progression or death due to any cause. PFS at 6 months will be estimated. The distribution of PFS will be estimated using the method of Kaplan-Meier.|from baseline up to 6 months|13 of the 16 phase II patients were eligible, treated, and analyzed.||months||95% Confidence Interval|Median
816023|NCT01105312|Secondary|Time-to-disease Progression (Phase II)|"Time-to-disease progression (TTP) is defined as the time from registration to documentation of disease progression. If a patient dies without a documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death. The distribution of TTP will be estimated using the method of Kaplan-Meier. Progression is defined as at least one of the following:
At least one new malignant lesion or a lymph node whose short axis has increased to >1.5 cm
At least a 20% increase in the sum of diameters of target lesions taking as reference the MSD. In addition, the sum must also demonstrate an absolute increase of at least 0.5 cm"|from baseline up to 6 months|13 of the 16 phase II patients were eligible, treated, and analyzed.||months||95% Confidence Interval|Median
816024|NCT01105312|Secondary|Survival Time (Phase II)|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier|from baseline up to 5 years post-registration|13 of the 16 phase II patients were eligible, treated, and analyzed.||months||95% Confidence Interval|Median
816025|NCT01105312|Primary|Response Rate (Phase II)|"A confirmed response is defined to be a CR or PR (as determined by RECIST (version 1.1 criteria) noted as the objective status on 2 consecutive evaluations at least 4 weeks apart. Response will be evaluated using all cycles of treatment. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response.
A CR is defined as:
All of the following must be true:
Disappearance of all non-nodal target lesions
Each target lymph node must have reduction in short axis to <1.0 cm
A PR is defined as:
At least a 30% decrease in the sum of the longest diameters of the non-nodal target lesions and the short axes of the target lymph nodes taking as reference the BSD (Section 11.41)"|from baseline up to 5 years post-registration|13 of the 16 patients enrolled were eligible, treated, and analyzed for this endpoint.||percentage of participants||95% Confidence Interval|Number
816026|NCT01105312|Primary|Maximum-tolerated Dose (Phase I)|MTD is defined as the dose level below the lowest dose that induces dose limiting toxicity in at least one-third of patients (at least 2 of a maximum of 6 > new patients). If dose-limiting toxicity (DLT) is not seen in any of the 3 patients, 3 new patients will be accrued and treated at the next higher dose level. If DLT are seen in 2 or 3 of 3 patients treated at a given dose level, then the next 3 patients will be treated at the next lower dose level, if only 3 patients were enrolled and treated at this lower dose level. The number of DLT's will be reported here.|Up to 2.5 months|All 12 phase I patients were eligible and analyzed for MTD.||Participants|||Count of Participants
816027|NCT01105377|Secondary|Time to Progression|Time to disease progression (TTP) is defined as the time from the start of treatment to the earliest of the date documenting disease progression or most recent assessment for patients having no progression. The distribution of TTP is estimated using the method of Kaplan-Meier.|From the start of treatment to the earliest of the date documenting disease progression, assessed up to 3 years|Analysis for this endpoint was “per protocol” and two participants were excluded. One participant in Cohort I was ineligible and one participant in Cohort II refused to start their 1st cycle of study treatment (ie, cancelled). Therefore, 23 participants in Cohort I and 22 participants in Cohort II were analyzed for this secondary endpoint.||months||95% Confidence Interval|Median
816028|NCT01105377|Primary|Confirmed Tumor Response|Each evaluable patient is classified as having a confirmed tumor response if they have either a complete response (CR) or partial response (PR) lasts at least 4 weeks. Tumor response is measured by using RECIST v1.1 (Response Evaluation Criteria in Solid Tumors). A CR is defined as a disappearance of all target lesions, and each target lymph node must have reduction in short axis to <1.0 cm. A PR is defined as a 30% decrease in the sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes at current evaluation, compared to pre-treatment measurements. The confirmed response rate is calculated as the number of confirmed CR+PR, divided by the total number of evaluable patients, with 95% confidence intervals estimated using the approach of Duffy and Santner.|At 6 month evaluation|Analysis was performed “per protocol” using only Cohort II participants, except those deemed ineligible, cancelled, or in major treatment violation during cycle 1. One of the 23 Cohort II participants was excluded in the analysis due to cancelling before initiating treatment.||percentage of participants||95% Confidence Interval|Number
816029|NCT01105533|Other Pre-specified|Effect of Food on Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)]|AUC (0-24)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-24).|Pre-dose,0.5,1,2,4,6,8,18,20,24 hrs post-dose on Day 29 (fasted state), Day 30 (fed state) for once daily groups, pre-dose,0.5,1,2,4,6,8 hrs post-dose on Day 29 Day 29 (fasted state), Day 30 (fed state) for twice daily groups|Formal quality-assured, quality-controlled, PK analysis was not performed and hence, food effect on AUC (0-24) was not assessed.|||||
816030|NCT01105533|Secondary|Change From Baseline in Biomarkers at Day 1 of Each Cycle up to Cycle 25|Biomarkers included soluble plasma proteins associated with angiogenesis (vascular endothelial growth factor [VEGF], soluble vascular endothelial growth factor-2 receptor [sVEGFR2], soluble vascular endothelial growth factor-3 receptor [sVEGFR3], soluble beta type platelet-derived growth factor [sPDGFR beta]) and tumor proliferation (soluble stem-cell factor receptor [sKIT])|Baseline, Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25|Results are not reported as the data were not statistically summarized but available in individual participant listing.|||||
816031|NCT01105533|Secondary|Number of Participants With Objective Response of Complete Response or Partial Response|Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all target and non-target lesions and no appearance of new lesions. Confirmed PR defined as at least 30 percent decrease in sum of the longest dimensions (LD) of the target lesions, taking as a reference the baseline sum LD, without progression of non-target lesions and no appearance of new lesions. Confirmed responses are those that persist on repeat imaging study >=4 weeks after initial documentation of response.|Baseline, every 8 weeks up to Cycle 25 (Week 100)|Full Analysis set included all enrolled participants who received at least 1 dose of study medication.||participants|||Number
816032|NCT01105533|Secondary|Systemic Clearance (CL)|CL is a quantitative measure of the rate at which a drug substance is removed from the body.|Pre-dose,0.5,1,2,4,6,8,10,16,20,24 hrs post-dose on Day 1(0.67 mg group);pre-dose,0.5,1,2,4,6,8,18,20,24 hrs post-dose on Day 1,15,29(once daily groups);pre-dose,0.5,1,2,4,6,8 hrs post-dose on Day 1,15,29 (twice daily groups);pre-dose on Day 43, 57|Formal quality-assured, quality-controlled, PK analysis was not performed and hence, CL was not calculated.|||||
816033|NCT01105533|Secondary|Apparent Volume of Distribution (Vss)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose is influenced by the fraction absorbed.|Pre-dose,0.5,1,2,4,6,8,10,16,20,24 hrs post-dose on Day 1(0.67 mg group);pre-dose,0.5,1,2,4,6,8,18,20,24 hrs post-dose on Day 1,15,29(once daily groups);pre-dose,0.5,1,2,4,6,8 hrs post-dose on Day 1,15,29 (twice daily groups);pre-dose on Day 43, 57|Formal quality-assured, quality-controlled, pharmacokinetic (PK) analysis was not performed and hence, Vss was not calculated.|||||
816034|NCT01105533|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Pre-dose,0.5,1,2,4,6,8,10,16,20,24 hrs post-dose on Day 1(0.67 mg group);pre-dose,0.5,1,2,4,6,8,18,20,24 hrs post-dose on Day 1,15,29(once daily groups);pre-dose,0.5,1,2,4,6,8 hrs post-dose on Day 1,15,29 (twice daily groups);pre-dose on Day 43, 57|Formal quality-assured, quality-controlled, pharmacokinetic (PK) analysis was not performed and hence, AUC (0 - ∞) was not calculated.|||||
816035|NCT01105533|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)]|AUC (0-24)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-24).|Pre-dose,0.5,1,2,4,6,8,10,16,20,24 hrs post-dose on Day 1(0.67 mg group);pre-dose,0.5,1,2,4,6,8,18,20,24 hrs post-dose on Day 1,15,29(once daily groups);pre-dose,0.5,1,2,4,6,8 hrs post-dose on Day 1,15,29 (twice daily groups);pre-dose on Day 43, 57|Formal quality-assured, quality-controlled, pharmacokinetic (PK) analysis was not performed and hence, AUC (0-24) was not calculated.|||||
816036|NCT01105533|Secondary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Pre-dose,0.5,1,2,4,6,8,10,16,20,24 hrs post-dose on Day 1(0.67 mg group);pre-dose,0.5,1,2,4,6,8,18,20,24 hrs post-dose on Day 1,15,29(once daily groups);pre-dose,0.5,1,2,4,6,8 hrs post-dose on Day 1,15,29 (twice daily groups);pre-dose on Day 43, 57|Formal quality-assured, quality-controlled, pharmacokinetic (PK) analysis was not performed and hence, t1/2 was not calculated.|||||
816037|NCT01105533|Secondary|Maximum Observed Plasma Concentration (Cmax)||Pre-dose,0.5,1,2,4,6,8,10,16,20,24 hours(hrs) post-dose on Day 1(0.67 mg group);pre-dose,0.5,1,2,4,6,8,18,20,24 hrs post-dose on Day 1,15,29(once daily groups);pre-dose,0.5,1,2,4,6,8 hrs post-dose on Day 1,15,29 (twice daily groups);pre-dose on Day 43, 57|Formal quality-assured, quality-controlled, pharmacokinetic (PK) analysis was not performed and hence, Cmax was not calculated.|||||
816038|NCT01105533|Primary|Recommended Phase-2 Dose (RP2D)|RP2D was determined based on the safety profile and pharmacodynamic findings. The twice daily dosing was preferred over once daily dosing for RP2D, as per investigator's discretion, due to more consistent changes in pharmacodynamic markers and greater clinical benefit observed in twice daily dosing.|Day 28|Safety analysis set included all enrolled participants who received at least 1 dose of study medication.||mg twice daily|||Number
816039|NCT01105533|Primary|Maximum Administered Dose (MAD)|MAD: dose level at which 2 or more out of 6 participants experienced DLT during Cycle 1. DLTs: blood pressure of 180/110 mmHg or higher for 3 readings over 3 hours regardless of use of anti-hypertensive drugs or >160/100 mmHg for 3 readings over 3 days on maximum anti-hypertensive drugs; afebrile Grade 4 neutropenia >=7 days or >= Grade 3 neutropenia associated with fever (1 reading of oral temperature >38.5 degree C or 3 readings of oral temperature >38.0 degree C in 24-hour period); Grade 4 thrombocytopenia; hemoptysis of >1/2 teaspoon of bright red blood per day; proteinuria of >=2 grams/24 hours; inability to resume PF-00337210 dosing at current dose level within 14 days of stopping due to treatment-related toxicity; >=Grade 3 nonhematological toxicities (except alopecia and blood pressure/hypertension); Grade 3 nonhematological toxicities that could be controlled to Grade 2 or less with appropriate treatment were not considered dose limiting.|Day 28|Safety analysis set included all enrolled participants who received at least 1 dose of study medication.||mg once daily|||Number
816490|NCT01108835|Secondary|Mortality|From contacting the patient/their family and hospital record retrieval.|12 months|||participants|||Number
816040|NCT01105533|Primary|Maximum Tolerated Dose (MTD)|MTD: dose level at which no more than 1 of 6 participants experienced DLT during Cycle 1. DLTs: blood pressure of 180/110 mmHg or higher for 3 readings over 3 hours regardless of use of anti-hypertensive drugs or >160/100 mmHg for 3 readings over 3 days on maximum anti-hypertensive drugs; afebrile Grade 4 neutropenia >=7 days or >= Grade 3 neutropenia associated with fever (1 reading of oral temperature >38.5 degree C or 3 readings of oral temperature >38.0 degree C in 24-hour period); Grade 4 thrombocytopenia; hemoptysis of >1/2 teaspoon of bright red blood per day; proteinuria of >=2 grams/24 hours; inability to resume PF-00337210 dosing at current dose level within 14 days of stopping due to treatment-related toxicity; >=Grade 3 nonhematological toxicities (except alopecia and blood pressure/hypertension); Grade 3 nonhematological toxicities that could be controlled to Grade 2 or less with appropriate treatment were not considered dose limiting.|Day 28|Safety analysis set included all enrolled participants who received at least 1 dose of study medication.||mg once daily|||Number
816041|NCT01105533|Primary|Number of Participants With Dose-limiting Toxicities (DLTs)|DLTs included events occurring in Cycle 1: blood pressure of 180/110 millimeters of mercury (mmHg) or higher for 3 readings over 3 hours regardless of use of anti-hypertensive drugs or greater than (>) 160/100 mmHg for 3 readings over 3 days on maximum anti-hypertensive drugs; afebrile Grade 4 neutropenia for greater than or equal to (>=) 7 days or >=Grade 3 neutropenia associated with fever (1 reading of oral temperature >38.5 degree Celsius [degree C] or 3 readings of oral temperature >38.0 degree C in 24-hour period); Grade 4 thrombocytopenia; hemoptysis of >1/2 teaspoon of bright red blood per day; proteinuria of >=2 grams/24 hours; inability to resume PF-00337210 dosing at current dose level within 14 days of stopping due to treatment-related toxicity; >=Grade 3 nonhematological toxicities (except alopecia and blood pressure/hypertension); Grade 3 nonhematological toxicities that could be controlled to Grade 2 or less with appropriate treatment were not considered dose limiting.|Baseline up to Day 28|Safety analysis set included all enrolled participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||participants|||Number
816042|NCT01105650|Secondary|Overall Survival|Number of participants alive at 1 year.|1 Year|||participants|||Number
816043|NCT01105650|Secondary|Number of Participants With Progressive Disease at One Year||1 Year|||Participants|||Count of Participants
816044|NCT01105650|Secondary|Time to Disease Progression|Time from study entry until progressive disease or data collection cutoff.|1 Year|"Number of participants with progressive disease at one year:
Arm 1: 2 out of 3; Arm 2: 1 out of 3; Arm 3: 5 out of 7"||days||Full Range|Median
816045|NCT01105650|Primary|Response Rate|Response includes Complete Response (CR), Partial Response (PR), and Stable Disease (SD) as defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v.1.1) for target lesions and assessed by CT or MRI. Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease.|Month 3|||participants|||Number
816046|NCT01105702|Secondary|Number of Patients With Grade 3 or 4 Adverse Events|Adverse events evaluated per CTCAE 3|The whole time while on treatment and 30 days after the treatment|all the patients with treatment||participants|||Number
816047|NCT01105702|Secondary|Median Overall Survival (OS)|OS defined as time from diagnosis to most recent follow up or death.|Up to 50 months|intent-to-treat population||months||95% Confidence Interval|Median
816048|NCT01105702|Primary|Median Progression-Free Survival (PFS)|PFS defined as time from date of diagnosis to most recent follow up, disease progression, or death. Disease progress defined as either clinical deterioration or radiographic progressive disease on magnetic resonance imaging (MRI) per updated response assessment in neuro-oncology criteria (Wen, et al).|Up to 50 months|Intent-to-treat population||months||95% Confidence Interval|Median
816049|NCT01105754|Secondary|Number of Children Who Received Guideline-based Asthma Care During the Intervention Visit.|The number of children who received guideline-based asthma care (eg: inhaled steroid prescription, counseling for triggers, counseling for adherence) at the intervention visit based on parent interview at the 2-week follow-up and medical record review.|2 week follow-up, and medical record review|||participants|||Number
816050|NCT01105754|Primary|Symptom Free Days|The primary outcome is asthma morbidity measured by the number of symptom-free asthma days (SFD) reported over 2 weeks at the 2-month follow-up assessment.|2 month follow-up assessment|||Days||Standard Deviation|Mean
816051|NCT01105767|Primary|Incidence of Methicillin-resistant Staphylococcus Aureus (MRSA)-Associated SSTI||At the end of the 20 month study|||participants|||Number
816052|NCT01105767|Primary|Incidence of Skin and Soft Tissue Infection (SSTI)||At the end of the 20 month study|||participants|||Number
816053|NCT01105936|Secondary|Subjective NRS Response for Treatment Effect on Patello-femoral Stimulation After the fMRI Scan: [NRS (P-f Post-scan)]|Subjective NRS response for each participant for treatment effect on tibio-femoral stimulus after the fMRI scan was calculated as difference of pre-treatment pain assessment after stimulus and post-treatment post-scan pain assessment after stimulus on patello-femoral. NRS responses was based on an 11 scale rating (0-10), with 0 corresponding to “No Pain” and 10 corresponding to “Extreme Pain or Pain as bad as you can imagine”.|Baseline and post-dose post-scan after stimulus|ITT population: all participants per period who received at least one treatment and had at least one post-baseline efficacy assessment. Missing data was not imputed.||Score on a Scale||Standard Deviation|Mean
816054|NCT01105936|Secondary|Subjective NRS Response for Treatment Effect on Tibio-femoral Stimulation After the fMRI Scan: [NRS (T-f Post-scan)]|Subjective NRS response for treatment effect on tibio-femoral stimulus after the fMRI scan was calculated for each participant as difference of pre-treatment pain assessment after stimulus and post-treatment post-scan pain assessment after stimulus on tibio-femoral. NRS responses was based on an 11 scale rating (0-10), with 0 corresponding to “No Pain” and 10 corresponding to “Extreme Pain or Pain as bad as you can imagine”.|Baseline and post-dose post-scan after stimulus|ITT population: all participants per period who received at least one treatment and had at least one post-baseline efficacy assessment. Missing data was not imputed.||Score on a Scale||Standard Deviation|Mean
816300|NCT01107418|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to 8 Hours (AUC[0-8h]) of Vemurafenib on Day 1||Pre-dose, 1, 2, 4, 5, 8 hours post-dose on Day 1|Pharmacokinetic (PK) population included all participants who provided essential PK data up to and including the pre-dose PK sample taken on Cycle 1, Day 22, without major protocol violation.||micrograms*hour/milliliter (mcg*h/mL)||Standard Deviation|Mean
816055|NCT01105936|Secondary|Subjective NRS Response for Treatment Effect on Patello-femoral Stimulation Prior the fMRI Scan: [NRS (P-f Pre-scan)]|Subjective NRS response was calculated for each participant as difference of pre-treatment pain assessment after stimulus and post-treatment pre-scan pain assessment after stimulus on patello-femoral. NRS responses was based on an 11 scale rating (0-10), with 0 corresponding to “No Pain” and 10 corresponding to “Extreme Pain or Pain as bad as you can imagine”.|Baseline and post-dose pre-scan after stimulus|ITT population: all participants per period who received at least one treatment and had at least one post-baseline efficacy assessment. Missing data was not imputed.||Score on a Scale||Standard Deviation|Mean
816056|NCT01105936|Secondary|Subjective NRS Response for Treatment Effect on Tibio-femoral Stimulation Prior the fMRI Scan: [NRS (T-f Pre-scan)]|Subjective NRS response was calculated for each participant as difference of pre-treatment pain assessment after stimulus and post-treatment pre-scan pain assessment after stimulus on tibio-femoral joint. NRS responses was based on an 11 scale rating (0-10), with 0 corresponding to “No Pain” and 10 corresponding to “Extreme Pain or Pain as bad as you can imagine”.|Baseline and post-dose pre-scan after stimulus|ITT population: all participants per period who received at least one treatment and had at least one post-baseline efficacy assessment. Missing data was not imputed.||Score on a Scale||Standard Deviation|Mean
816057|NCT01105936|Secondary|Subjective Numerical Rating Scale (NRS) Response for Treatment Effect on OA Knee Before Stimulation: [NRS (TRT)]|Subjective NRS response for each participant was calculated as difference of pre-treatment NRS pain assessment before stimulus and post-treatment NRS pain assessment before stimulus. NRS responses was based on an 11 scale rating (0-10), with 0 corresponding to “No Pain” and 10 corresponding to “Extreme Pain or Pain as bad as you can imagine”.|Baseline and post-dose before stimulus|ITT population: all participants per period who received at least one treatment and had at least one post-baseline efficacy assessment. Missing data was not imputed.||Score on a Scale||Standard Deviation|Mean
816058|NCT01105936|Secondary|BOLD Response in the Patello-femoral Joint of Knee Osteoarthritis: [BOLD (P-f)]|BOLD response to painful pressure stimuli was evaluated using fMRI. Voxel-wise BOLD scores were reported on a Z-scale (Gaussian,mean=0,SD=1); range -3 (worst score, lowest connectivity) to +3 (best score, highest connectivity). The software derived scores compared the intensity reading in the region to a template, specifically the Montreal Neurological Institute (MNI) Echo-Planar Image (EPI) template. The template provides, for each region, expected (mean/median) intensity for that region, along with expected variation. The BOLD score on the Z-scale represents how far the actual measured intensity is from the expected in the template. A score of 0 would correspond to the mean/median, a score of 1.65 would represent the 90-percentile, -1.65 the 10-percentile, and so on, according to a standard normal distribution|Baseline to 2-5 hours post last dose administration|ITT population: all participants per period who received at least one treatment and had at least one post-baseline efficacy assessment. Missing data was not imputed.||Z-score||Standard Deviation|Mean
816059|NCT01105936|Primary|Blood Oxygen Level-Dependent (BOLD) Response in the Tibio-femoral Joint of Knee Osteoarthritis (OA): [BOLD (T-f)]|BOLD response to painful pressure stimuli was evaluated using fMRI. Voxel-wise BOLD scores were reported on a Z-scale (Gaussian,mean=0,SD=1); range -3 (worst score, lowest connectivity) to +3 (best score, highest connectivity). The software derived scores compared the intensity reading in the region to a template, specifically the Montreal Neurological Institute (MNI) Echo-Planar Image (EPI) template. The template provides, for each region, expected (mean/median) intensity for that region, along with expected variation. The BOLD score on the Z-scale represents how far the actual measured intensity is from the expected in the template. A score of 0 would correspond to the mean/median, a score of 1.65 would represent the 90-percentile, -1.65 the 10-percentile, and so on, according to a standard normal distribution.|Baseline to 2-5 hours post last dose administration|Intention-to-treat (ITT) population: all participants per period who received at least one treatment and had at least one post-baseline efficacy assessment. Missing data was not imputed.||Z-score||Standard Deviation|Mean
816060|NCT01106014|Secondary|Absence of Worsening From Baseline to Week 26 in Modified NYHA/WHO Functional Class (WHO FC)||Week 26|Full analysis set. Patients with WHO FC IV at baseline were excluded from this analysis as they could not shift to a worse category||Percentage of patients|||Number
816061|NCT01106014|Secondary|Change From Baseline to Week 26 in 6-minute Walk Distance (6MWD) at Trough|The 6-minute walk distance test (6MWD) is a non-encouraged test performed in a 30 m long flat corridor, where the patient is instructed to walk as far as possible, back and forth around two cones, with the permission to slow down, rest, or stop if needed. If the patient was used to taking bronchodilators before a walk, he/she was given them 5 to 30 min before the test. Also if the patient was on chronic oxygen therapy, oxygen was given at their standard rate during the test. Absolute change from baseline to Week 26 in 6MWD was measured at trough, i.e., either on the next day after the last study drug administration or at least 12 hours after study drug administration if on the same day.|Week 26|Full analysis set||Meters||Full Range|Median
816062|NCT01106014|Primary|Time From Randomization to the First Morbidity Event or Death (All Causes) up to 7 Days After the Last Study Drug Intake|"Time from randomization to the first occurrence of a morbidity event or death (all causes) was analyzed with the Kaplan-Meier method (event-free KM estimates at different time points).
Morbidity event was defined as any of the following events confirmed by the Critical Event committee:
Hospitalization for worsening of pulmonary arterial hypertension (PAH),
Worsening of PAH resulting in need for lung transplantation or balloon atrial septostomy,
Initiation of parenteral prostanoid therapy or chronic oxygen therapy due to worsening of PAH,
Disease progression which was defined by a decrease in 6-minute walk distance from baseline (>=15%, confirmed by a 2nd test on a different day) combined with worsening of WHO FC for patients belonging to WHO FC II/III at baseline, or combined with the need for additional PAH-specific therapy for patients belonging to WHO FC III/IV at baseline.
Note: The number of patients at risk decreased over time but this cannot be captured below"|Up to 7 days after end of double-blind treatment (maximum: 4.3 years)|The primary endpoint was analyzed using the full analysis set, which includes all randomized patients evaluated according to the study drug to which they have been randomized (intention-to treat analysis set).||Percentage of patients free of events||95% Confidence Interval|Number
816077|NCT01106092|Secondary|Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T)|Seroprotection was defined as anti-D and anti-T antibody concentration ≥ 0.1 international units per milliliter (IU/mL).|Prior to (At Month 0) and one month after booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.||Participants|||Count of Participants
816063|NCT01106040|Secondary|Reverse Concordance of Blue Dye and Lymphoseek|The proportion of lymph nodes detected intraoperatively by Lymphoseek that were also detected by blue dye.|Surgery after injections of Lymphoseek and blue dye|All enrolled patients who were injected with both Lymphoseek and blue dye, who underwent surgery and had at least one lymph node detected by Lymphoseek (at ≥ 3σ count) in vivo, and for whom the tissue type (lymphatic/non-lymphatic) and pathology status (presence/absence of tumor cells) was confirmed.||Proportion of Lymph Nodes|Participants|95% Confidence Interval|Number
816064|NCT01106040|Primary|Concordance of Blue Dye and Lymphoseek|The proportion of lymph nodes detected intraoperatively by blue dye that were also detected by Lymphoseek.|Surgery after injections of Lymphoseek and blue dye|All enrolled patients who were injected with both Lymphoseek and blue dye, who underwent surgery and had at least one lymph node stained intraoperatively by blue dye, and for whom the tissue type (lymphatic/non-lymphatic) and pathology status (presence/absence of tumor cells) was confirmed.||Proportion of Lymph Nodes|Participants|95% Confidence Interval|Number
816065|NCT01106092|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Month 0 to Month 1)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.||Participants|||Count of Participants
816066|NCT01106092|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Day 0-Day 30) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.||Participants|||Count of Participants
816067|NCT01106092|Secondary|Number of Subjects With Any Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade.|During the 8-day (Days 0-7) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.||Participants|||Count of Participants
816068|NCT01106092|Secondary|Number of Subjects With Any Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.|During the 8-day (Days 0-7) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.||Participants|||Count of Participants
816069|NCT01106092|Secondary|Number of Subjects With a Booster Response for Anti-BPT|Booster response was defined as: For initially seronegative subjects, antibody concentration ≥ 15 EL.U/mL one month after the booster dose. For initially seropositive subjects: antibody concentration one month after the booster dose ≥ 2 fold the pre-booster antibody concentration.|One month after booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.||Participants|||Count of Participants
816070|NCT01106092|Secondary|Anti-BPT Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.|Prior to (At Month 0) and one month after booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
816071|NCT01106092|Secondary|Number of Seropositive Subjects for Anti-Bordetella Pertussis (Anti-BPT)|Seropositivity was defined as anti-BPT antibody concentration ≥ 15 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).|Prior to (At Month 0) and one month after the booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.||Participants|||Count of Participants
816072|NCT01106092|Secondary|Anti-PRP Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in μg/mL.|Prior to (At Month 0) and one month after booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.||μg/mL||95% Confidence Interval|Geometric Mean
816073|NCT01106092|Secondary|Number of Seroprotected Subjects Against Polyribosil-ribitol-phosphate (PRP)|Seprotection was defined as anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (μg/mL).|Prior to (At Month 0) and one month after booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subject for whom immunogenicity data were available.||Participants|||Count of Participants
816074|NCT01106092|Secondary|Anti-HBs Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.|Prior to (At Month 0) and one month after the booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.||mIU/mL||95% Confidence Interval|Geometric Mean
816075|NCT01106092|Secondary|Number of Seroprotected and Seropositive Subjects for Anti-hepatitis B (Anti-HBs)|Seropositivity was defined as anti-HBs antibody concentration ≥ 3.3 milli-international units per milliliter (mIU/mL). Seprotection was defined as anti-HBs antibody concentration ≥ 10 mIU/mL. Note that percentage of subjects with concentration ≥ 10 mIU/mL was over-estimated due to the use of in-house assay overestimating concentrations between 10-100 mIU/mL. Accordingly GMCs were also overestimated. A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis. Some of the available blood samples initially tested with ELISA were re-tested using the new assay, CLIA.|Prior to (At Month 0) and one month after the booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.||Participants|||Count of Participants
816078|NCT01106092|Secondary|Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3|Seroprotection was defined as anti-polio types 1, 2 and 3 antibody titres ≥ 8 effective dose (ED50), for 50% of vaccinated subjects.|Prior to booster vaccination (At Month 0)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.||Participants|||Count of Participants
816079|NCT01106092|Secondary|Number of Seroconverted Subjects for Anti-polio Types 1, 2 and 3|Seroconversion was defined as: For initially seronegative subjects, antibody titer ≥ 8 ED50 one month after the booster dose. For initially seropositive subjects: antibody titer one month after the booster dose ≥ 4 fold the pre-booster antibody titer. For subjects with pre-booster antibody titer below the highest dilution tested (reciprocal < 8192 ED50): highest dilution tested one month after the booster dose (reciprocal > 8192 ED50).|One month after booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.||Participants|||Count of Participants
816080|NCT01106092|Primary|Anti-polio Types 1, 2 and 3|Antibody titers were presented as geometric mean titers (GMTs).|One month after booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.||Titers||95% Confidence Interval|Geometric Mean
816081|NCT01106092|Primary|Anti-polio Types 1, 2 and 3|Antibody titers were presented as geometric mean titers (GMTs).|Prior to booster vaccination (At Month 0)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.||Titers||95% Confidence Interval|Geometric Mean
816082|NCT01106092|Primary|Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3|Seroprotection was defined as anti-polio types 1, 2 and 3 antibody titres ≥ 8 effective dose (ED50), for 50% of vaccinated subjects.|One month after booster vaccination (At Month 1)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.||Participants|||Count of Participants
816083|NCT01106157|Secondary|Change in White Blood Count (WBC) From Baseline to 12 Months|Change in WBC over 12 months|Change from baseline to 12 months|||Change in percentage of WBC||Standard Deviation|Mean
816084|NCT01106157|Secondary|Percentage of Neutrophils|Change in Neutrophil Count over 12 months|Change from baseline to 12 months|||Percentage of neutrophils||Standard Deviation|Mean
816085|NCT01106157|Secondary|Change in Zinc Transporter 8 Autoantibodies (ZnT8A) From Baseline to 12 Months|Change in Zinc Transporter 8 Autoantibodies (ZnT8A) over 12 months|Change from baseline to 12 months|||nmol/L||Standard Deviation|Mean
816086|NCT01106157|Secondary|Change in Insulinoma Associated 2 Autoantibodies (IA-2A) From Baseline to 12 Months|Change in Insulinoma Associated 2 Autoantibodies (IA-2A)|Change from baseline to 12 months|||nmol/L||Standard Deviation|Mean
816087|NCT01106157|Secondary|Change in Insulin Autoantibodies (IAA) From Baseline to 12 Months|Change in Insulin Autoantibodies (IAA) over 12 months|Change from baseline to 12 months|||Units/mL||Standard Deviation|Mean
816088|NCT01106157|Secondary|Change in Glutamic Acid Decarboxylase Antibodies (GADA) From Baseline to 12 Months|Change in Glutamic Acid Decarboxylase Antibodies (GADA) over 12 months|Change from baseline to 12 months|||nmol/L||Standard Deviation|Mean
816089|NCT01106157|Secondary|Change in Insulin Requirements, Baseline to 12 Months|Change in Insulin Requirements, baseline to 12 months|Change from baseline to 12 months|Insulin use data was not provided by all subjects resulting in sampling for analysis that was smaller than the cohort for the entire study.||units/kg/day||Standard Deviation|Mean
816090|NCT01106157|Secondary|A1c|Change in A1c baseline to 12 months|Change in baseline to 12 months|||% change||Standard Deviation|Mean
816091|NCT01106157|Secondary|Percent Change in Regulatory T Cells (Treg) Baseline to 12 Months|Change in regulatory T cells (Treg) baseline to 12 months|Change in Baseline to 12 months|||percentage change||Standard Deviation|Mean
816092|NCT01106157|Primary|Change in Metabolic Function Baseline to 12 Months.|Area Under Curve (AUC) C-peptide production. Subjects underwent a 2 hour mixed meal tolerance test (MMTT) using a 6ml/kg load of boost to stimulate insulin production. Samples were collected at baseline, 10 minutes, 20 minutes, 30 minutes, 60 minutes, 90 minutes, and 120 minutes. AUC was then calculated. Subjects repeated the MMTT at baseline, 3, 6, 9, and 12 months following ATG/GCSF or placebo. The primary outcome for the study was the change over 12 months in AUC C-peptide (1 year - baseline) for those who received ATG/GCSF versus the change in AUC C-peptide (1 year - baseline) for those who received placebo|Baseline and 12 months|||nmol/L/min||Standard Deviation|Mean
816093|NCT01106248|Secondary|Pharmacokinetic Profile of Eribulin Mesylate: Time to Maximum Observed Plasma Concentration (Tmax).|Pharmacokinetic profile of eribulin mesylate (tmax).|Days 1 and 8|Pharmacokinetic Population||hours||Full Range|Median
816094|NCT01106248|Secondary|To Further Explore the Safety and Tolerability of Eribulin Mesylate When Administered on Days 1 and 8 of a 21-day Cycle in Patients With Solid Tumors.||21 day cycle||||||
816095|NCT01106248|Secondary|To Assess Best Overall Response Using RECIST Criteria in Patients With Measurable Disease.||21 day cycle||||||
816096|NCT01106248|Secondary|Pharmacokinetic Profile of Eribulin Mesylate: Observed Maximal Plasma Concentration (Cmax)|Pharmacokinetic profile of eribulin mesylate (Cmax).|Days 1 and 8|Pharmacokinetic Population||ng/mL||Standard Deviation|Mean
816097|NCT01106248|Primary|Mean Time-matched, Baseline Corrected QTcF at Any Time Point Postdosing.|The primary endpoint is mean time-matched, baseline corrected QTcF at any time point postdosing. This was to determine the effect of eribulin on cardiac repolarization as measured by QT/QTc interval.|48 hours postdose after Day 1 and after Day 8|Per Protocol Population||msec||Standard Deviation|Mean
816098|NCT01106287|Primary|Number of Participants Who Discontinued Study Drug Due to an Adverse Event|Only treatment-emergent adverse events were examined for this outcome measure.|Up to 6 weeks after the first dose of study drug|All participants receiving any dose of MK-0941 of placebo.||participants|||Number
816099|NCT01106287|Primary|Number of Participants Who Experienced One or More Adverse Events During the Study||Up to 30 days after the last dose of study drug|All participants receiving any dose of MK-0941 or placebo||participants|||Number
816100|NCT01106326|Secondary|Additional Asthma Morbidity Measures|We also will compare additional baseline asthma morbidity measures, quality of life, health care utilization, cotinine, and exhaled nitric oxide with outcomes at the follow-up assessments.|2 month, 4 month, final follow-up assessments||||||
816101|NCT01106326|Primary|Number of Symptom-free Days Over Two Weeks|We will measure number of symptom-free days at 2-months (at the end of the directly observed therapy phase) and 4-months (after their transition to independence with preventive medications). We anticipate that teens will experience more symptom-free days compared to baseline assessment.|2 and 4 month follow-up assessments|Analysis conducted per protocol.||Days||Standard Deviation|Mean
816102|NCT01106352|Other Pre-specified|Number of Subjects Who Responded to Interactive Voice Response System (IVRS) Pain|The subject completed the full BPI (short form) paper questionnaire, and clinical staff completed the analgesic log. The test consists of 10 questions addressing severity, location, chronicity, and amount of relief. In question 3, subjects with pain are asked to evaluate the severity of pain at worst in the past 24 hours in a 0 to 10 scale, with 0 indicating no pain, and 10 indicating the worst pain.|From start of study treatment until 12 months|Subjects included in the per protocol: All subjects in the ITT population who received at least 40% of the specified number of administrations of radium-223 dichloride (in the radium-223 dichloride cohort) or of docetaxel (in the docetaxel cohort), and who did not have any major protocol violations.||Participants|||Number
816103|NCT01106352|Other Pre-specified|Overall Survival Rate|The overall survival (OS) time in days was calculated as number of days since the day of first dose of study medication until the date of death.|12 months|Subjects included in the per protocol: All subjects in the ITT population who received at least 40% of the specified number of administrations of radium-223 dichloride (in the radium-223 dichloride cohort) or of docetaxel (in the docetaxel cohort), and who did not have any major protocol violations.||days||95% Confidence Interval|Median
816104|NCT01106352|Other Pre-specified|Progression Free Survival (PFS) End Point|PFS defined as the time from randomization (randomization referred to the date of treatment assignment) to disease progression (radiological or clinical, whichever was earlier) or death (if death occurred before progression was documented). Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation.|From start of study treatment to 12 months, at every 12 weeks|Subjects included in the per protocol: All subjects in the ITT population who received at least 40% of the specified number of administrations of radium-223 dichloride (in the radium-223 dichloride cohort) or of docetaxel (in the docetaxel cohort), and who did not have any major protocol violations.||days||95% Confidence Interval|Median
816105|NCT01106352|Other Pre-specified|Exploratory Efficacy: Time to Clinical or Radiographic Progression|"Time to first radiologic or clinical progression is determined by one of the following:
For soft tissue lesions, the determination is based on Response Evaluation Criteria in Solid Tumors 1.1.
For bone disease, the determination is based on Prostate Cancer Working Cohort 2 (PCWG2) definitions, which require the appearance of at least 2 new lesions with a confirmatory bone scan at least 6 or more weeks later. For clinical progression, the investigators followed the recommendations of the PCWG25 and used their clinical judgment to determine clinical progression."|From start of study treatment to 12 months, at every 12 weeks|Subjects included in the per protocol: All subjects in the ITT population who received at least 40% of the specified number of administrations of radium-223 dichloride (in the radium-223 dichloride cohort) or of docetaxel (in the docetaxel cohort), and who did not have any major protocol violations.||days||95% Confidence Interval|Median
816106|NCT01106352|Other Pre-specified|Exploratory Efficacy: Percent Change From Baseline in Circulating Tumor Cells at Day 85|CTCs were measured to follow the evolution of the level of CTCs after treatment.|Baseline, Day 85, expanded safety cohort|Subjects included in the per protocol: All subjects in the ITT population who received at least 40% of the specified number of administrations of radium-223 dichloride (in the radium-223 dichloride cohort) or of docetaxel (in the docetaxel cohort), and who did not have any major protocol violations.||Percent Change||Standard Deviation|Mean
816107|NCT01106352|Other Pre-specified|Exploratory Efficacy: Time to Prostate-specific Antigen (PSA) Progression|Serum PSA progression defined as two consecutive increases in PSA over a previous reference value within 6 months of first study treatment, each measurement at least 1 week apart.|12 months|Subjects included in the per protocol: All subjects in the ITT population who received at least 40% of the specified number of administrations of radium-223 dichloride (in the radium-223 dichloride cohort) or of docetaxel (in the docetaxel cohort), and who did not have any major protocol violations.||days||95% Confidence Interval|Median
816108|NCT01106352|Other Pre-specified|Exploratory Efficacy: Weighted Mean Area Under the Curve for Bone Turnover Biomarkers|Weighted mean area under the curve for the below bone turnover biomarkers were evaluated, ICTP = pyridinoline cross-linked carboxyterminal telopeptide P1NP = N-terminal peptide of procollagen type 1 uCTX-1 = urine C-telopeptide 1|From start of study treatment to 6 weeks after study treatment (maximum 12 weeks in dose escalation; 30 weeks in the expanded safety cohort)|Subjects included in the per protocol: All subjects in the ITT population who received at least 40% of the specified number of administrations of radium-223 dichloride (in the radium-223 dichloride cohort) or of docetaxel (in the docetaxel cohort), and who did not have any major protocol violations.||mcg/L||Standard Deviation|Mean
816109|NCT01106352|Primary|Number of Subjects With Signs of Long-Term Radiation Toxicity|Long-term radiation toxicity included incidence of potential late toxicity, such as new primary cancers and bone marrow changes (acute myelogenous leukemia, myelodysplastic syndrome, and aplastic anemia).|From start of study treatment upto 12 months|Only participants who received treatment were assessed||Participants|||Number
816110|NCT01106352|Primary|Number of Subjects With Physical Examination During the Treatment Period|Any physical examination finding that was classified by the investigator as a clinically significant change (compared with previous examination) was considered an AE, documented on the eCRF, and followed until the outcome was known. The below physical examination findings were recorded and reported. GDASC = General disorders and administration site conditions MND = Metabolism and nutrition disorders SSTD= Skin and subcutaneous tissue disorders MCTD = Musculoskeletal and connective tissue disorders IPPC = Injury, poisoning and procedural complications RTMD = Respiratory, thoracic and mediastinal disorders NBMU = Neoplasms benign, malignant and unspecified (include cysts and polyps) In the below table.|From start of study treatment to 6 weeks after study treatment (i.e., maximum 12 weeks in dose escalation; 30 weeks in the expanded safety cohort)|Only participants who received treatment were assessed||Participants|||Number
816124|NCT01106391|Primary|Rate of Technical Success Through the One Month Follow up.|Technical success is defined as the successful deployment of the stent-graft to the desired location in the absence of Types I, III or IV endoleaks at the conclusion of the procedure and through the one month follow up.|From procedure to one month follow up|All enrolled subjects||participants|||Number
816111|NCT01106352|Primary|Changes From Baseline in Weight During the Treatment Period|In the below table, ‘n’ signifies those subjects who were evaluable for this measure at given time points for each group.|From start of study treatment to 6 weeks after study treatment (that is, maximum 12 weeks in dose escalation; 30 weeks in the expanded safety cohort)|Only participants who received treatment were assessed||kilogram(s)||Standard Deviation|Mean
816112|NCT01106352|Primary|Changes From Baseline in Heart Rate During the Treatment Period|In the below table, ‘n’ signifies those subjects who were evaluable for this measure at given time points for each group.|From start of study treatment to 6 weeks after study treatment (that is, maximum 12 weeks in dose escalation; 30 weeks in the expanded safety cohort)|Only participants who received treatment were assessed||beats per min||Standard Deviation|Mean
816113|NCT01106352|Primary|Changes From Baseline in Respiratory Rate During the Treatment Period|In the below table, ‘n’ signifies those subjects who were evaluable for this measure at given time points for each group.|From start of study treatment to 6 weeks after study treatment (that is, maximum 12 weeks in dose escalation; 30 weeks in the expanded safety cohort)|Only participants who received treatment were assessed||breaths/min||Standard Deviation|Mean
816114|NCT01106352|Primary|Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period|In the below table, ‘n’ signifies those subjects who were evaluable for this measure at given time points for each group.|From start of study treatment to 6 weeks after study treatment (that is, maximum 12 weeks in dose escalation; 30 weeks in the expanded safety cohort)|Only participants who received treatment were assessed||millimeters of mercury (mmHg)||Standard Deviation|Mean
816115|NCT01106352|Primary|Change From Baseline in Serum Biochemistry (Erythrocytes) During the Treatment Period|In the below table, ‘n’ signifies those subjects who were evaluable for this measure at given time points for each group.|Baseline, Day 106 (dose escalation period), and Day 190 (expanded safety cohort)|Only participants who received treatment were assessed||tetra per liter (TI/L)||Standard Deviation|Mean
816116|NCT01106352|Primary|Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period|In the below table, ‘n’ signifies those subjects who were evaluable for this measure at given time points for each group.|Baseline, Day 106 (dose escalation period), and Day 190 (expanded safety cohort)|Only participants who received treatment were assessed||giga per liter (GI/L)||Standard Deviation|Mean
816117|NCT01106352|Primary|Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period|In the below table, ‘n’ signifies those subjects who were evaluable for this measure at given time points for each group.|Baseline, Day 106 (dose escalation period), and Day 190 (expanded safety cohort)|Only participants who received treatment were assessed||millimole(s)/liter||Standard Deviation|Mean
816118|NCT01106352|Primary|Change From Baseline in Serum Biochemistry (Bilirubin, Creatinine) During the Treatment Period|In the below table, ‘n’ signifies those subjects who were evaluable for this measure at given time points for each group.|Baseline, Day 106 (dose escalation period), and Day 190 (expanded safety cohort)|Only participants who received treatment were assessed||micromole(s)/litre||Standard Deviation|Mean
816119|NCT01106352|Primary|Change From Baseline in Serum Biochemistry (Alkaline Phosphatase [AP], Alanine Aminotransferase [AAT], Lactate Dehydrogenase [LD]) During the Treatment Period|In the below table, ‘n’ signifies those subjects who were evaluable for this measure at given time points for each group.|Baseline, Day 106 (dose escalation period), and Day 190 (expanded safety cohort)|Only participants who received treatment were assessed||units per liter (U/L)||Standard Deviation|Mean
816120|NCT01106352|Primary|Change From Baseline in Serum Biochemistry (Albumin, Protein, Hemoglobin) During the Treatment Period|In the below table, ‘n’ signifies those subjects who were evaluable for this measure at given time points for each group.|Baseline, Day 106 (dose escalation period), and Day 190 (expanded safety cohort)|Only randomized participants who have this outcome measure tested were assessed||gram per liter (G/L)||Standard Deviation|Mean
816121|NCT01106352|Primary|Number of Subjects With Treatment-Emergent Adverse Events (TEAE), Treatment-Emergent Serious Adverse Events (TESAE) With a CTCAE Grade of 3 or 4|Treatment-emergent adverse event (TEAEs) were defined as events that occur following the first injection of study treatment, or that started prior to the first injection and worsened during treatment. An adverse event (AE) was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. An Serious Adverse Event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in patient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse events were defined as adverse events/serious adverse events that started or worsened after the study drug treatment.|From start of study treatment to 6 weeks after study treatment (that is maximum 12 weeks in dose escalation; 30 weeks in the expanded safety cohort) and 8 weeks for serious AEs|Only participants who received treatment were assessed||Participants|||Number
816122|NCT01106352|Primary|Number of Subjects With Dose-Limiting Toxicities – Dose Escalation Part|DLT was defined as - Absolute neutrophil count grade greater than or equal to (>=) 4 (Common Terminology Criteria for Adverse Events [CTCAE], Version 4.0: less than [<] 0.5 × 109 per Liter) lasting longer than 7 days without fever despite granulocyte colony-stimulating factor (G-CSF) support). Platelet count Grade >= 4 (CTCAE, v4.0: < 25× 109/L) lasting longer than 7 days. Diarrhea Grade >= 3 (CTAE, v4.0: increase of >= 7 stools per day over baseline; incontinence; hospitalization indicated; severe increase in ostomy output compared with baseline; limiting self-care in activities of daily living) in spite of optimal use of antidiarrheal medication. Vomiting or constipation Grade >= 4 (CTCAE, v4.0: life-threatening consequences; urgent intervention indicated). Febrile neutropenia Grade >= 3 (CTCAE, v4.0).|From randomization until 6 weeks post-injection in all dose cohort of dose-escalation part|||Participants|||Number
816123|NCT01106391|Primary|Rate of Primary Safety Endpoint Within 1 Month Post-procedure.|Primary safety is defined by the absence of Types I, III or IV endoleaks and device and/or procedural related major adverse events within 1 month post-procedure. Major adverse events include death, MI, stroke and renal failure.|One month follow-up|The analysis population consists of subjects with complete core laboratory data at 1 month.||participants|||Number
817124|NCT01119768|Secondary|Symptom Relief Rate After 2 Weeks and 8 Weeks in 8 Weeks Treatment Group.|Symptom relief is defined as no more than 1 day of mild symptoms of GERD during previous 7 days after 8 weeks or 2 weeks of treatment.|2 and 8 weeks|ITT in 8 weeks treatment group||percentage of participants|||Number
816125|NCT01106404|Secondary|NPRS Scores From Baseline to Follow-up Visits at 10 Weeks and 16 Weeks Post-implant|The 11-point (ie, 0-10) numeric rating scale of pain intensity (NPRS) was used to assess the overall pain at baseline and follow-up visits. In the pain diary, subjects were presented a numeric scale with numbers from 0 to 10, with 0 meaning “No pain” and 10 meaning “Pain as bad as you can imagine,” accompanied by the instructions “Please rate your pain by indicating the number that best describes your pain on average in the last 24 hours.” The subjects were asked to complete a diary for 7 consecutive days before implant, 10 weeks, and 16 weeks post-implant visits.|Baseline, 10 weeks and 16 weeks post-implant|69 of the 76 subjects completed pain diary for both baseline and 10 weeks. 69 of the 76 subjects completed pain diary for both baseline and 16 weeks. Since 2 datasets had 2 different pairs of data due to different subjects who completed the pain diary, baseline NPRS in two analyses varied slightly.||units on a scale||Standard Deviation|Mean
816126|NCT01106404|Secondary|Manual Adjustments Presented as Button Presses|The number of individual adjustments, ie, button presses, were recorded automatically in the patient programmer, which was specifically designed for this study. The number of button presses per day for manual patient programmer adjustments during the manual programming arm and the AdaptiveStim programming arm of the study were compared.|Baseline, 10 weeks and 16 weeks post-implant|Subjects with manual adjustments data from patient programmer were included in the analysis.||Button presses per day||Standard Deviation|Mean
816127|NCT01106404|Secondary|Percentage of Subjects With Worsened Pain Relief When Using AdaptiveStim Compared to Manual Programming|The pain relief question was a 5-point Likert scale question comparing pain relief when using AdaptiveStim programming relative to manual programming after subjects finished both programming periods. The choices were much worse pain relief with AdaptiveStim, somewhat worse pain relief with AdaptiveStim, no difference in pain relief, somewhat better pain relief with AdaptiveStim, and much better pain relief with AdaptiveStim. Subjects who had worsening pain relief were defined as subjects who responded “much worse pain relief with AdaptiveStim” or “somewhat worse pain relief with AdaptiveStim”.|16 weeks post-implant|A total of 71 subjects with completed data were included in this analysis.||percentage of participants|||Number
816128|NCT01106404|Primary|Percentage of Subjects With Improved Pain Relief and/or Convenience During the AdaptiveStim Programming Arm Relative to the Manual Programming Arm|After subjects experienced both AdaptiveStim and manual programming at 16 weeks post-implant, subjects were asked to compare pain relief and convenience when they had AdaptiveStim ON to AdaptiveStim OFF in two separate domains using two 5-point Likert scales. The outcome measure for the primary objective is the percentage of subjects who report improved pain relief with no loss of convenience or improved convenience with no loss of pain relief during the AdaptiveStim programming arm relative to the manual programming arm. These subjects were considered successful for the primary objective.|16 weeks post-implant|"The ITT analysis included 74 subjects; 2 randomized subjects, who discontinued early due to infections, were excluded per protocol. The 3 other subjects who discontinued early were included in ITT analysis and imputed as failures for the primary objective.
No imputation method was used for 71 subjects included in the completed case analysis."||percentage of participants|||Number
816129|NCT01106430|Secondary|Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1|UKU-SERS-Clin is composed of 48 items each of which asks about a single side effect. Each side effect is rated based on a 4-point scale ranging from 0 (no or doubtful presence) to 3 (the least favorable rating). The rating is independent of whether the symptom is regarded as related to the investigational product.|9 weeks|Safety Population defined as all subjects who were randomized and who had taken at least 1 dose of investigational product.||participants|||Number
816130|NCT01106430|Secondary|Columbia-Suicide Severity Rating Scale (C-SSRS)|C-SSRS is a semi-structured interview that captures the occurence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale.|9 weeks|Safety Population defined as all subjects who were randomized and who had taken at least 1 dose of investigational product.||participants|||Number
816131|NCT01106430|Secondary|Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRS-C) Total Score at Up to 9 Weeks|The BPRS-C characterizes psychopathology. A total of 21 items are rated on a scale from 0 (not present) to 6 (extremely severe) with a total score ranging from 0 to 126. A decrease in score indicates a reduction in psychopathology.|Baseline and up to 9 weeks|Safety Population defined as all subjects who were randomized and who had taken at least 1 dose of investigational product.||units on a scale||Standard Deviation|Mean
816132|NCT01106430|Secondary|Health Utilities Index-2 (HUI-2) Scores at Up to 9 Weeks|HUI is used to describe health status and to obtain utility scores by collecting data using one or more questionnaires in formats selected to match the specific study design criteria. Scoring ranges from 0.00 (dead) to 1.00 (perfect health). Higher scores represent better health status.|up to 9 weeks|Full Analysis Set defined as all subjects who were randomized and who had taken at least 1 dose of investigational product.||units on a scale||Standard Deviation|Mean
816133|NCT01106430|Secondary|Change From Baseline in the Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at Up to 9 Weeks|The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.|Baseline and up to 9 weeks|Full Analysis Set defined as all subjects who were randomized and who had taken at least 1 dose of investigational product.||units on a scale||Standard Error|Least Squares Mean
816134|NCT01106430|Secondary|Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-Fourth Edition (ADHD-RS-IV) Total Score at 9 Weeks - LOCF|ADHD-RS-IV consists of 18 items scored on a 4-point scale from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. A decrease in score indicates an improvement in ADHD symptomology.|Baseline and 9 weeks|Full Analysis Set defined as all subjects who were randomized and who had taken at least 1 dose of investigational product.||units on a scale||Standard Error|Least Squares Mean
816235|NCT01100944|Secondary|Progression Free Survival (PFS)|Duration of time from start of treatment to time of progression or death whichever occurs first.|Start of treatment to time of disease progression or death whichever occurs first, assessed up to 43 months|One patient hospitalized for viral meningoencephalitis during the first cycle was not evaluable. The reason median was not reached is that patients with thymoma have a more indolent disease with a longer survival, therefore a longer duration of response.||months||Full Range|Median
816135|NCT01106430|Secondary|Percent of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores - Last Observation Carried Forward (LOCF)|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|9 weeks|Full Analysis Set defined as all subjects who were randomized and who had taken at least 1 dose of investigational product.||percentage of participants|||Number
816136|NCT01106430|Primary|Time to First Response|Time to first response was defined as a Clinical Global Impression-Improvement (CGI-I) value of 1 (very much improved) or 2 (much improved) first recorded following first dose of investigational product. CGI-I consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).|9 weeks|Full Analysis Set defined as all subjects who were randomized and who had taken at least 1 dose of investigational product. One subject was randomized to receive Strattera, but actually received Lisdexamfetamine Dimesylate. For all efficacy analyses this subject is included in the Strattera arm per the intention to treat principle.||Days||95% Confidence Interval|Median
816137|NCT01106456|Primary|7-Day Point Prevalence Abstinence From Smoking for 6 Months|The primary outcome of the study was salivary cotinine-verified 7-day point prevalence smoking abstinence at 6 months (Have you smoked at least part of a cigarette in the past 7 days?) using responders-only analyses.|6 months|"The difference in the overall number of participants analyzed, from the number analyzed, in the ANBL arm, is due to missing data."||Participants|||Count of Participants
816147|NCT01106586|Secondary|The Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48||Week 48|ITT analysis set. The missing = failure (M = F) method was used in which all missing data were considered as failure (HIV-1 RNA ≥ 50 copies/mL).||percentage of participants|||Number
816148|NCT01106586|Secondary|The Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Weeks 48, 96, 144, and 192|Change = value of the relevant time point minus the baseline value|Baseline; Weeks 48, 96, 144, and 192|ITT analysis set. The missing = excluded (M = E) method was used in which participants with missing data were excluded from analysis.||cells/µL||Standard Deviation|Mean
816149|NCT01106586|Secondary|The Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 50 Copies/mL at Week 48 Using the FDA-defined Time to Loss of Virologic Response (TLOVR) Algorithm||Week 48|ITT analysis set||percentage of participants|||Number
816150|NCT01106586|Secondary|The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 192||Week 192|Week 192 modified intent-to-treat (MITT) Analysis Set: Participants in the ITT analysis set, excluding those who either 1) transferred to other Gilead-sponsored studies after completing their Week 144 Visit and before the lower limit of the Week 192 analysis window, or 2) prematurely discontinued study drug prior to the Week 144 Visit.||percentage of participants|||Number
816151|NCT01106586|Secondary|The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 144||Week 144|ITT Analysis Set||percentage of participants|||Number
816152|NCT01106586|Secondary|The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 96||Week 96|ITT Analysis Set||percentage of participants|||Number
816153|NCT01106586|Primary|The Percentage of Participants With Virologic Success Using the Food and Drug Administration (FDA)-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 Ribonucleic Acid (RNA) < 50 Copies/mL at Week 48||Week 48|ITT analysis set: participants who were randomized into the study and received at least 1 dose of study drug||percentage of participants|||Number
816154|NCT01106625|Secondary|Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26|The table below shows the least-squares (LS) mean percent change in HDL-C from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percent change||Standard Error|Least Squares Mean
816155|NCT01106625|Secondary|Percent Change in Triglycerides From Baseline to Week 26|The table below shows the least-squares (LS) mean percent change in triglycerides from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percent change||Standard Error|Least Squares Mean
816156|NCT01106625|Secondary|Change in Systolic Blood Pressure (SBP) From Baseline to Week 26|The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||mmHg||Standard Error|Least Squares Mean
816157|NCT01106625|Secondary|Percent Change in Body Weight From Baseline to Week 26|The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percent change||Standard Error|Least Squares Mean
816158|NCT01106625|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26|The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||mg/dL||Standard Error|Least Squares Mean
816159|NCT01106625|Secondary|Percentage of Patients With HbA1c <7% at Week 26|The table below shows the percentage of patients with HbA1c<7% at Week 26 in each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage.|Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percentage of patients|||Number
816160|NCT01106625|Primary|Change in HbA1c From Baseline to Week 26|The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percent||Standard Error|Least Squares Mean
816161|NCT01106651|Secondary|Percent Change in Total Hip Bone Mineral Density (BMD) From Baseline to Week 26|The table below shows the least-squares (LS) mean percent change from Baseline to Week 26 in total hip BMD for each treatment group as assessed by dual-energy X-ray absorptiometry (DXA). The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in LS mean percent change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percent change||Standard Error|Least Squares Mean
816162|NCT01106651|Secondary|Percent Change in Femoral Neck Bone Mineral Density (BMD) From Baseline to Week 26|The table below shows the least-squares (LS) mean percent change from Baseline to Week 26 in femoral neck BMD for each treatment group as assessed by dual-energy X-ray absorptiometry (DXA). The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in LS mean percent change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percent change||Standard Error|Least Squares Mean
816191|NCT01106690|Secondary|Change in Systolic Blood Pressure (SBP) From Baseline to Week 26|The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||mmHg||Standard Error|Least Squares Mean
816163|NCT01106651|Secondary|Percent Change in Distal Forearm Bone Mineral Density (BMD) From Baseline to Week 26|The table below shows the least-squares (LS) mean percent change from Baseline to Week 26 in distal forearm BMD for each treatment group as assessed by dual-energy X-ray absorptiometry (DXA). The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in LS mean percent change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percent change||Standard Error|Least Squares Mean
816164|NCT01106651|Secondary|Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Baseline to Week 26|The table below shows the least-squares (LS) mean percent change from Baseline to Week 26 in lumbar spine BMD for each treatment group as assessed by dual-energy X-ray absorptiometry (DXA). The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in LS mean percent change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percent change||Standard Error|Least Squares Mean
816165|NCT01106651|Secondary|Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26|The table below shows the least-squares (LS) mean percent change in HDL-C from Baseline to Week 26 or each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percent change||Standard Error|Least Squares Mean
816166|NCT01106651|Secondary|Percent Change in Triglycerides From Baseline to Week 26|The table below shows the least-squares (LS) mean percent change in triglycerides from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percent change||Standard Error|Least Squares Mean
816167|NCT01106651|Secondary|Change in Systolic Blood Pressure (SBP) From Baseline to Week 26|The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||mmHg||Standard Error|Least Squares Mean
816168|NCT01106651|Secondary|Change in Tissue Percent Total Fat From Baseline to Week 26 in a Subset of Patients Undergoing Specific Dual-energy X-ray Absorptiometry (DXA) Analysis for Body Composition|Tissue percent total fat = body fat as a percentage of body fat + lean body mass. The table below shows the least-squares (LS) mean change in tissue percent total fat from Baseline to Week 26 for each treatment group in patients randomized to the subset of patients undergoing specific DXA analysis for body composition. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percent||Standard Error|Least Squares Mean
816169|NCT01106651|Secondary|Change in Region Percent Total Fat From Baseline to Week 26 in a Subset of Patients Undergoing Specific Dual-energy X-ray Absorptiometry (DXA) Analysis for Body Composition|Region percent total fat = body fat as a percentage of (body fat + lean body mass + bone mass content). The table below shows the least-squares (LS) mean change in region percent total fat from Baseline to Week 26 for each treatment group in patients randomized to the subset of patients undergoing specific dual-energy X-ray absorptiometry (DXA) analysis for body composition. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percent||Standard Error|Least Squares Mean
816170|NCT01106651|Secondary|Change in Total Fat From Baseline to Week 26 in a Subset of Patients Undergoing Specific Dual-energy X-ray Absorptiometry (DXA) Analysis for Body Composition|The table below shows the least-squares (LS) mean change in total fat from Baseline to Week 26 for each treatment group in patients randomized to the subset of patients undergoing specific DXA analysis for body composition. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||kg||Standard Error|Least Squares Mean
816218|NCT01100853|Secondary|Beck Depression Inventory|The Beck Depression Inventory is a self-administered questionnaire that assess the severity of depressive symtpoms. It consists of 21 items about how the subject has been feeling in the last week, and each item has a set of at least four possible answer choices, ranging in intensity, yielding scores from 0-3, with a total possible score of 63. Higher scores indicate more severe depressive symptoms.|24 weeks|||BDI Score||Standard Deviation|Mean
816171|NCT01106651|Secondary|Percent Change in Body Weight From Baseline to Week 26|The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percent change||Standard Error|Least Squares Mean
816172|NCT01106651|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26|The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||mg/dL||Standard Error|Least Squares Mean
816173|NCT01106651|Secondary|Percentage of Patients With HbA1c <7% at Week 26|The table below shows the percentage of patients with HbA1c <7% at Week 26 in each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage.|Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percentage of patients|||Number
816174|NCT01106651|Primary|Change in HbA1c From Baseline to Week 26|The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percent||Standard Error|Least Squares Mean
816175|NCT01106677|Secondary|Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 52|The table below shows the least-squares (LS) mean percent change in HDL-C from Baseline to Week 52 for each active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean percent change.|Day 1 (Baseline) and Week 52|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 52 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percent change||Standard Error|Least Squares Mean
816176|NCT01106677|Secondary|Percent Change in Triglycerides From Baseline to Week 52|The table below shows the least-squares (LS) mean percent change in triglycerides from Baseline to Week 52 for each active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean percent change.|Day 1 (Baseline) and Week 52|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 52 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percent change||Standard Error|Least Squares Mean
816177|NCT01106677|Secondary|Change in Systolic Blood Pressure (SBP) From Baseline to Week 52|The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 52 for each active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean change.|Day 1 (Baseline) and Week 52|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 52 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||mmHg||Standard Error|Least Squares Mean
816178|NCT01106677|Secondary|Percent Change in Body Weight From Baseline to Week 52|The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 52 for each active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean percent change.|Day 1 (Baseline) and Week 52|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 52 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percent change||Standard Error|Least Squares Mean
816179|NCT01106677|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 52|The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 52 for each active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean change.|Day 1 (Baseline) and Week 52|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 52 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||mg/dL||Standard Error|Least Squares Mean
816180|NCT01106677|Secondary|Change in HbA1c From Baseline to Week 52|The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 52 for each active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean change.|Day 1 (Baseline) and Week 52|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 52 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percent||Standard Error|Least Squares Mean
816181|NCT01106677|Secondary|Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26|The table below shows the least-squares (LS) mean percent change in HDL-C from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the LS mean percent change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percent change||Standard Error|Least Squares Mean
816182|NCT01106677|Secondary|Percent Change in Triglycerides From Baseline to Week 26|The table below shows the least-squares (LS) mean percent change in triglycerides from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the LS mean percent change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percent change||Standard Error|Least Squares Mean
816183|NCT01106677|Secondary|Change in Systolic Blood Pressure (SBP) From Baseline to Week 26|The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||mmHg||Standard Error|Least Squares Mean
816184|NCT01106677|Secondary|Percent Change in Body Weight From Baseline to Week 26|The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the LS mean percent change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percent change||Standard Error|Least Squares Mean
816185|NCT01106677|Secondary|Change in 2-hour Post-prandial Glucose From Baseline to Week 26|The table below shows the least-squares (LS) mean change in 2-hour post-prandial glucose from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||mg/dL||Standard Error|Least Squares Mean
816186|NCT01106677|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26|The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||mg/dL||Standard Error|Least Squares Mean
816187|NCT01106677|Secondary|Percentage of Patients With HbA1c <7% at Week 26|The table below shows the percentage of patients with HbA1c <7% at Week 26 in each treatment group. The statistical analyses show the treatment differences between each canagliflozin or sitagliptin group and placebo.|Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percentage of patients|||Number
816188|NCT01106677|Primary|Change in HbA1c From Baseline to Week 26|The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percent||Standard Error|Least Squares Mean
816189|NCT01106690|Secondary|Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26|The table below shows the least-squares (LS) mean percent change in HDL-C from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percent change||Standard Error|Least Squares Mean
816190|NCT01106690|Secondary|Percent Change in Triglycerides From Baseline to Week 26|The table below shows the least-squares (LS) mean percent change in triglycerides from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percent change||Standard Error|Least Squares Mean
816192|NCT01106690|Secondary|Percent Change in Body Weight From Baseline to Week 26|The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percent change||Standard Error|Least Squares Mean
816193|NCT01106690|Secondary|Change in Homeostasis Model Assessment (HOMA2-%B) From Baseline to Week 26|HOMA2-%B is a measure of beta cell function (the cells in the pancreas that produce and store insulin). The table below shows the least-squares (LS) mean change in HOMA2-%B from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||HOMA2-%B||Standard Error|Least Squares Mean
816194|NCT01106690|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26|The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||mg/dL||Standard Error|Least Squares Mean
816195|NCT01106690|Secondary|Percentage of Patients With HbA1c <7% at Week 26|The table below shows the percentage of patients with HbA1c<7% at Week 26 in each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage.|Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percentage of patients|||Number
816196|NCT01106690|Primary|Change in HbA1c From Baseline to Week 26|The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percent||Standard Error|Least Squares Mean
816197|NCT01106846|Primary|Quality of Recovery Score Post Operative at 24 Hours|Quality of recovery 40 score at 24 hours after the surgical procedure. 40 being a poor recovery and 200 being a good recovery.|24 hours post operative|||units on scale||Standard Deviation|Mean
816198|NCT01106859|Secondary|Probability of Differences From Placebo Exceeding The 3.5 cm Threshold in Standard Deviation of Lateral Position (SDLP) Following Administration of Active Therapy|"This table represents the probability of driving performance changes summarized in the previous table. It answers the question: What is the chance that # participants out of the total number of participants had better (or worse) driving performance? Probability values of <.001 are listed in the data table as 0.000.
A symmetry analysis was conducted for the probability of difference in mean SDLP (treatment) - mean SDLP (placebo) exceeding thresholds. Statistically significant asymmetries indicate a decrement in driving performance."|3-9 hours post dose|Intent to treat population||proportion|||Number
816199|NCT01106859|Secondary|Number of Participants Whose Standard Deviation of Lateral Position (SDLP) Following Active Treatment As Compared to Placebo In Relation To The 3.5 cm SDLP Threshold|SDLP was measured by an infrared camera mounted on the car's roof during a highway driving test. Lateral position of the car relative to the left lane boundary was recorded. The data summarizes the number of participants whose driving performance was worse, neutral or improved as compared to placebo at the 3.5 cm threshold. A neutral driving performance shows a difference of SDLP >= 3.5 cm and <= -3.5 cm when compared to placebo. A worse performance is when the difference of SDLP > 3.5 cm, and an improved performance is when the difference of SDLP < -3.5 cm.|3-9 hours post dose|Intent to treat population||participants|||Number
816200|NCT01106859|Secondary|Probability of Differences From Placebo Exceeding The 2.0 cm Threshold in Standard Deviation of Lateral Position (SDLP) Following Administration of Active Therapy|"This table represents the probability of driving performance changes summarized in the previous table. It answers the question: What is the chance that # participants out of the total number of participants had better (or worse) driving performance? Probability values of <.001 are listed in the data table as 0.000.
A symmetry analysis was conducted for the probability of difference in mean SDLP (treatment) - mean SDLP (placebo) exceeding thresholds. Statistically significant asymmetries indicate a decrement in driving performance."|3-9 hours post dose|Intent to treat population||proportion|||Number
816201|NCT01106859|Secondary|Number of Participants Whose Standard Deviation of Lateral Position (SDLP) Following Active Treatment As Compared to Placebo In Relation To The 2.0 cm SDLP Threshold|SDLP was measured by an infrared camera mounted on the car's roof during a highway driving test. Lateral position of the car relative to the left lane boundary was recorded. The data summarizes the number of participants whose driving performance was worse, neutral or improved as compared to placebo at the 2.0 cm threshold. A neutral driving performance shows a difference of SDLP >= 2.0 cm and <= -2.0 cm when compared to placebo. A worse performance is when the difference of SDLP > 2.0 cm, and an improved performance is when the difference of SDLP < -2.0 cm.|3-9 hours post dose|Intent to treat population||participants|||Number
816292|NCT01107418|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC[0-24h]) of Vemurafenib on Day 15||Pre-dose, 1, 2, 4, 5, 8, 24 hours post-dose on Day 15|PK population. Here, number of participants analyzed signifies participants evaluable for this outcome.||mcg*h/mL||Standard Deviation|Mean
816202|NCT01106859|Primary|Probability of Differences From Placebo Exceeding The 2.5 cm Threshold in Standard Deviation of Lateral Position (SDLP) Following Administration of Active Therapy|"This table represents the probability of driving performance changes summarized in the previous table. It answers the question: What is the chance that # participants out of the total number of participants had better (or worse) driving performance? Probability values of <.001 are listed in the data table as 0.000.
A symmetry analysis was conducted for the probability of difference in mean SDLP (treatment) - mean SDLP (placebo) exceeding thresholds. Statistically significant asymmetries indicate a decrement in driving performance."|3-9 hours post dose|Intent to treat population||proportion|||Number
816203|NCT01106859|Primary|Number of Participants Whose Standard Deviation of Lateral Position (SDLP) Following Active Treatment As Compared to Placebo In Relation To The 2.5 cm SDLP Threshold|SDLP was measured by an infrared camera mounted on the car’s roof during a highway driving test. Lateral position of the car relative to the left lane boundary was recorded. The data summarizes the number of participants whose driving performance was worse, neutral or improved as compared to placebo at the 2.5 cm threshold. A neutral driving performance shows a difference of SDLP >= 2.5 cm and <= -2.5 cm when compared to placebo. A worse performance is when the difference of SDLP > 2.5 cm, and an improved performance is when the difference of SDLP < -2.5 cm.|3-9 hours post dose|Intent to treat population||participants|||Number
816204|NCT01106859|Secondary|Summary of Participants With Treatment Emergent Adverse Experiences (TEAEs)|Adverse Events were graded by the investigator using the World Health Organization (WHO) Adverse Event Grading Scale and were assessed for severity (mild, moderate, severe) and relatedness (summarized as 'unrelated' and 'related') to study treatment. Also included are counts of participants with serious AEs, AEs leading to discontinuation of study treatment, and deaths.|Day 1 -6 weeks|Safety population (participants who were randomized and received at least one dose of study drug)||participants|||Number
816205|NCT01106859|Secondary|Mean Standard Deviation of Speed (SDS) in the Highway Drive Test|Mean standard deviation of speed (SDS) is a common measure of the driver's ability to maintain a constant driving speed. Variations in driving speed are recorded and analyzed.|3-9 hours post dose|Intent to treat population. In one Zopiclone case, the velocity of the car was not recorded due to technical problems, and therefore SDS could not be calculated in this drive.||kilometers/hour||Standard Error|Least Squares Mean
816206|NCT01106859|Secondary|Mean Standard Deviation of Lateral Position (SDLP) in the Highway Driving Test|Standard deviation of lateral position (SDLP) in a highway-driving lane is a surrogate measure for driving performance. It measures the driver's ability to stay in a constant position within the driving lane. Variations in the lateral position are recorded and analyzed.|3-9 hours post dose|Intent to treat population||centimeters||Standard Error|Least Squares Mean
816207|NCT01106911|Primary|Number of Participants Without Cancer Who Were Recalled|Recall rates of digital breast tomosynthesis and full field digital mammography in younger women undergoing their initial screening mammogram will be assessed and compared.|upon recruitment/enrollment phase completion|Includes only participants who were not diagnosed as having a breast malignancy.||participants|||Number
816208|NCT01106950|Secondary|Percent of Patients With Natural Killer Cell Expansion Versus KIR Genotype Versus Treg Depletion|Association between in vivo natural killer (NK) cell expansion and complete response without platelet recovery (CRp) with donor killer immunoglobulin-like (KIR) genotype and Treg depletion. In vivo donor NK cell expansion was correlated with regulatory T-cell (Treg) depletion as detected on flow cytometry.|Day 14|||Percentage of patients|||Number
816209|NCT01106950|Secondary|Number of Patients With Treatment-Related Death|Number of patients who died within the first 100 days of treatment due to toxicity.|Day 100|||Percentage of patients|||Number
816210|NCT01106950|Secondary|Percent of Patients With Incidence of Relapse|Number of patients who have had a relapse(the return of disease after its apparent recovery/cessation) after obtaining a complete remission of their disease.|Month 6|||Percentage of patients|||Number
816211|NCT01106950|Secondary|Percent of Patients With Disease Free Survival|Number of patients alive and disease free at 6 months. The length of time after treatment ends that a patient survives without any signs or symptoms of that cancer or any other type of cancer. In a clinical trial, measuring the disease-free survival is one way to see how well a new treatment works.|Month 6|||Percentage of patients|||Number
816212|NCT01106950|Secondary|Percent of Patients With Complete Remission of Disease|Disease response was defined as complete remission (disease response) by morphologic criteria including <5% blasts in a moderately cellular or cellular marrow. Complete remission was also correlated with NK cell expansion in vivo, IL-15 levels and donor/recipient KIR B genotyping, and Treg depletion.|At least 4 weeks after last dose (28 days)|||Percentage of patients|||Number
816213|NCT01106950|Primary|Percent of Patients With Successful Expansion of Natural Killer Cells After Infusion|The primary objective of this study was to estimate the incidence of in vivo expansion of natural killer (NK) cells 14 days after infusion of an allogeneic donor product enriched for NK progenitors. Successful in vivo donor NK cell expansion was defined by measuring an absolute circulating donor-derived NK cell count of >100 cells/ul in the patient's peripheral blood 14 days after infusion.|Day 14|||Percentage of patients|||Number
816214|NCT01106976|Primary|AChE PET Neuroimaging|AChE PMP PET hydrolysis rate outcome measure. AChE [11C]PMP hydrolysis rates (k3) were estimated using the striatal volume of interest (defined by manual tracing on the MRI scan of the putamen and caudate nucleus) as the tissue reference for the integral of the precursor delivery. This measure is a proxy measure for the count of cholinergic nerve terminals in the basal forebrain innervation the cortical mantle.|4 yr|Parkinson disease.||1/min||Standard Deviation|Mean
816215|NCT01100853|Primary|Number Negative Urines (Proportion Negative Urines) Amphetamine||24 weeks|||Urine Drug Screen|||Number
816216|NCT01100853|Secondary|Prior Admissions to Vogur Hospital|Number of prior admissions due to substance dependence. The term “prior admissions” refers to admissions before enrollment, thus Baseline is the appropriate Time Frame.|Baseline|||Number of admissions||Standard Deviation|Mean
816217|NCT01100853|Secondary|Risk Assessment Battery|The Risk Assessment Battery is a 41 item self-report questionnaire that assess risk behaviors related to HIV infection over the past 6 months. The measure yields a Drug risk score ranging from 0-22 and a Sex risk score ranging from 0-18, with higher scores indicating more risk; these scores are added to yield a Total RAB score ranging from 0-40. This total scores is then divided by 40 to yield a RAB Scale Score from 0-1.|24 weeks|||Total Score||Standard Deviation|Mean
816222|NCT01100931|Primary|Phase 2 Objective Response Rate (Partial Response (PR) + Complete Response (CR)).|Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.Partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.|up to 18 weeks|Phase I is not included here because this outcome measure is for phase II only.||Participants|||Number
816223|NCT01100931|Primary|Phase 1 Safe and Tolerable Phase 2 Dose.|"Phase I: Doses were given at different dose levels until the maximum tolerated dose (MTD) was reached. Dose level 1: 3.6 mg/m^2, dose level 2:5 mg/m^2 , dose level 3:6 mg/m^2, dose level 4:8 mg/m^2, dose level 5:10 mg/m^2 (MTD), dose level 6:12 mg/m^2. Doses were given by continuous intravenous infusion over 72 hours every 21 days.Three patients were enrolled at each dose level in the absence of dose limiting toxicity (DLT). A DLT is defined as adverse events occurring during the first cycle of therapy (e.g. every 21 days).
Phase 2 dose is based upon dose limiting toxicities experienced during cycle 1."|1 year|Phase I dose was variable dosing schedule to determine maximum tolerated dose (MTD) with 22 patients analyzed. Dose was variable with MTD at 10mg/m^2.||mg/m^2|||Number
816224|NCT01100944|Secondary|Relative Changes in T Cell Immunoglobulin Domain and Mucin Domain-3 (TIM3)-Expressing Cluster of Differentiation 8 (CD8)+Tcells|Changes in marker levels from baseline. All pre values were set to 1 so that we could measure changes relative to the baseline.|Baseline Cycle 1 Day 1 (C1D1), Cycle 1 Day 2 (C1D2), Cycle 1 Day 3 (C1D3), and Cycle 2 Day 1 (C2D1)|One patient hospitalized for viral meningoencephalitis during the first cycle was not evaluable. Three samples could not be analyzed since they were of poor quality with too few cells for immune cell subset analysis or the samples could not be collected in time for pharmacodynamics analysis.||Relative fold change||Full Range|Median
816225|NCT01100944|Secondary|Relative Changes in the Number of Tregs With Treatment|Changes in marker levels from baseline. All pre values were set to 1 so that we could measure changes relative to the baseline.|Baseline Cycle 1 Day 1 (C1D1), Cycle 1 Day 2 (C1D2), Cycle 1 Day 3 (C1D3), and Cycle 2 Day 1 (C2D1)|One patient hospitalized for viral meningoencephalitis during the first cycle was not evaluable. Three samples could not be analyzed since they were of poor quality with too few cells for immune cell subset analysis or the samples could not be collected in time for pharmacodynamics analysis.||relative fold change||Full Range|Median
816226|NCT01100944|Secondary|Relative Change Observed in Total Protein Hyperacetylation of Cluster of Differentiation 3 (CD3)+T Cells With Belinostat|Changes in marker levels from baseline. All pre values were set to 1 so that we could measure changes relative to the baseline.|Baseline Cycle 1 Day 1 (C1D1), Cycle 1 Day 2 (C1D2), Cycle 1 Day 3 (C1D3), and Cycle 2 Day 1 (C2D1)|One patient hospitalized for viral meningoencephalitis during the first cycle was not evaluable. Two samples could not be analyzed since they were of poor quality with too few cells for immune cell subset analysis or the samples could not be collected in time for pharmacodynamics analysis.||Relative fold change||Full Range|Median
816227|NCT01100944|Secondary|Area Under the Plasma Concentration vs. Time Curve Extrapolated to Infinity (AUC(INF)/Dose|AUC is a measure of the serum concentration of Belinostat over time. It is used to characterize drug absorption.|on day 1: pre-belinostat and 0, 0.5, 1 and 2 hours after belinostat infusion, on day 3: 0, 0.8, 0.25, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-last belinostat dose|||hr*ng/ml/mg||Standard Deviation|Mean
816228|NCT01100944|Secondary|Area Under the Plasma Concentration vs. Time Curve Extrapolated to Infinity (AUC(INF))|AUC is a measure of the serum concentration of Belinostat over time. It is used to characterize drug absorption.|on day 1: pre-belinostat and 0, 0.5, 1 and 2 hours after belinostat infusion, on day 3: 0, 0.8, 0.25, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-last belinostat dose|||hr*ng/ml||Standard Deviation|Mean
816229|NCT01100944|Secondary|Time to Maximum Plasma Concentration (Tmax)|Time to reach peak concentration after drug administration.|on day 1: pre-belinostat and 0, 0.5, 1 and 2 hours after belinostat infusion, on day 3: 0, 0.8, 0.25, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-last belinostat dose|||Hour||Standard Deviation|Mean
816230|NCT01100944|Secondary|Maximum Plasma Concentration (Cmax)/Dose|Plasma concentrations of Belinostat were measured using a newly designed and validated ultra high-performance liquid chromatography (HPLC) with tandem mass spectrometric (MS/MS) assay, with a lower limit of quantification of 5ng/mL.|on day 1: pre-belinostat and 0, 0.5, 1 and 2 hours after belinostat infusion, on day 3: 0, 0.8, 0.25, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-last belinostat dose|||ng/ml/mg||Standard Deviation|Mean
816231|NCT01100944|Secondary|Maximum Observed Plasma Concentration (Cmax) of Belinostat|Plasma concentrations of Belinostat were measured using a newly designed and validated ultra high-performance liquid chromatography (HPLC) with tandem mass spectrometric (MS/MS) assay, with a lower limit of quantification of 5ng/mL.|on day 1: pre-belinostat and 0, 0.5, 1 and 2 hours after belinostat infusion, on day 3: 0, 0.8, 0.25, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-last belinostat dose|One patient was excluded from pharmacokinetic analysis due to insufficient sampling in dose level 2. Dose normalized parameters are normalized to absolute total dose (over 48 hours continuous intravenous infusion (CIVI)) for that patient, not dose level.||ng/ml||Standard Deviation|Mean
816232|NCT01100944|Secondary|Total Clearance (CL) of Belinostat|Clearance is the amount of time for the drug to be eliminated from the body.|on day 1: pre-belinostat and 0, 0.5, 1 and 2 hours after belinostat infusion, on day 3: 0, 0.8, 0.25, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-last belinostat dose|||L/hr||Standard Deviation|Mean
816233|NCT01100944|Secondary|Time to Half Life (t1/2) of Belinostat|Half life is the duration of time for the drug to be reduced to half the original amount.|on day 1: pre-belinostat and 0, 0.5, 1 and 2 hours after belinostat infusion, on day 3: 0, 0.8, 0.25, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-last belinostat dose.|||Hour||Standard Deviation|Mean
816234|NCT01100944|Secondary|Overall Survival (OS)|Overall survival is defined as the on-study date until the date of death or progression as appropriate.|Start of treatment to time of death, assessed up to 43 months|One patient hospitalized for viral meningoencephalitis during the first cycle was not evaluable. The reason median was not reached is that patients with thymoma have a more indolent disease with a longer survival, therefore a longer duration of response.||months||Full Range|Median
816293|NCT01107418|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to 8 Hours (AUC[0-8h]) of Vemurafenib on Day 15||Pre-dose, 1, 2, 4, 5, 8 hours post-dose on Day 15|PK population. Here, number of participants analyzed signifies participants evaluable for this outcome.||mcg*h/mL||Standard Deviation|Mean
816236|NCT01100944|Secondary|Duration of Response|Duration of response is measured from the time measurement criteria (e.g. Response Evaluation Criteria in Solid Tumors (RECIST)) are met for complete response (CR) or partial response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started).|From the time of first response until date of progression, assessed up to 43 months|One patient hospitalized for viral meningoencephalitis during the first cycle was not evaluable for response. The reason median was not reached is that patients with thymoma have a more indolent disease with a longer survival, therefore a longer duration of response||months||95% Confidence Interval|Median
816237|NCT01100944|Secondary|Time to Response|Time to response is the time between the first day of treatment until first date of response (complete response (CR) + partial response (PR)) (whichever is first recorded).|From the first day of treatment until the date of first documented response, assessed up to 43 months|One patient hospitalized for viral meningoencephalitis during the first cycle was not evaluable for response.||days||Full Range|Median
816238|NCT01100944|Secondary|Disease Control Rate (DCR)|DCR is defined as stable disease (SD) + partial response (PR) + complete response (CR) per the Response Criteria in Solid Tumors (RECIST).|43 months|One patient hospitalized for viral meningoencephalitis during the first cycle was not evaluable for response.||percentage of participants||95% Confidence Interval|Number
816239|NCT01100944|Secondary|Clinical Response|Response is defined by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease (PD) is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|43 months|One patient hospitalized for viral meningoencephalitis during the first cycle was not evaluable for response.||Participants|||Count of Participants
816240|NCT01100944|Secondary|Treatment-related Grade 3 and 4 Adverse Events (Highest Grade Per Event Per Patient)|Here are the number of patients with treatment -related grade 3 and 4 adverse events (highest grade per event per patient).|up to 122 months|||Participants|||Count of Participants
816241|NCT01100944|Secondary|Number of Participants With Serious and Non-serious Adverse Events|Here is the number of participants with serious and non-serious adverse events. For a detailed list of events, see the adverse event module.|up to 122 months|||Participants|||Count of Participants
816242|NCT01100944|Primary|Objective Response Rate (Partial Response (PR) + Complete Response (CR) of Belinostat in Combination With Cisplatin, Doxorubicin and Cyclophosphamide in the First Line Treatment of Patients With Advanced Thymic Malignancies|Objective response rate is the number of participants with a best objective response of partial response (PR) + complete response (CR) per the Response Criteria in Solid Tumors (RECIST) divided by the number of participants who had treatment.|43 months|One patient hospitalized for viral meningoencephalitis during the first cycle was not evaluable for response.||percentage of participants||95% Confidence Interval|Number
816243|NCT01100944|Primary|Number of Participants With Grade 3 and 4 Dose Limiting Toxicity (DLT) at 2000mg/m(2) Belinostat|A DLT is defined as grade 4 neutropenia lasting more than 7 days despite prophylactic or therapeutic use of granulocyte colony-stimulating factor (G-CSF), febrile neutropenia defined as absolute neutrophil count (ANC) less than 1000/mm(3) and temperature more than 38.5 degrees Celsius or 100.4 degrees Fahrenheit or life threatening sepsis, grade 4 thrombocytopenia or grade 3 thrombocytopenia associated with bleeding during the first cycle of therapy. Any grade 3 or 4 non-hematologic toxicity was considered dose limiting with the following exceptions: grade 3 diarrhea lasting less than 48 hours, grade 3 nausea and/or vomiting lasting less than 48 hours, grade 3 electrolyte abnormalities lasting less than 48 hours, grade 3 creatinine elevation lasting less than 48 hours.|up to 122 months|||Participants|||Count of Participants
816244|NCT01100944|Primary|Maximum Tolerated Dose (MTD) of Belinostat|The MTD is defined as the highest dose at which less than 2 out of 6 patients experienced a dose limiting toxicity (DLT). A DLT is defined as grade 4 neutropenia lasting more than 7 days despite prophylactic or therapeutic use of granulocyte colony-stimulating factor (G-CSF), febrile neutropenia defined as absolute neutrophil count (ANC) less than 1000/mm(3) and temperature more than 38.5 degrees Celsius or 100.4 degrees Fahrenheit or life threatening sepsis, grade 4 thrombocytopenia or grade 3 thrombocytopenia associated with bleeding during the first cycle of therapy. Any grade 3 or 4 non-hematologic toxicity was considered dose limiting with the following exceptions: grade 3 diarrhea lasting less than 48 hours, grade 3 nausea and/or vomiting lasting less than 48 hours, grade 3 electrolyte abnormalities lasting less than 48 hours, grade 3 creatinine elevation lasting less than 48 hours.|2 years|||mg/m(2)|||Number
816245|NCT01101022|Secondary|Change From Baseline in Adult ADHD Quality of Life (AAQoL) Scale Total Score at up to 10 Weeks|AAQoL is a validated 29-item scale consisting of 4 subscales. The AAQoL yields a total score and 4 subscale scores. Subjects rate each item on a 5-point Likert scale ranging from 1 (not at all/never) to 5 (extremely/very often). These scores are then transformed to a 0-100 point scale with higher scores indicating better quality of life.|Baseline and up to 10 weeks|FAS||Scores on a scale||Standard Error|Least Squares Mean
816246|NCT01101022|Secondary|Change From Baseline in CAARS-O:S Factor-derived Subscale T-scores at up to 10 Weeks|The CAARS-O:S is an assessment tool with prompts provided to an observer who describes ADHD-related symptoms in an adult subject. The 26-item scale is scored on a 4-point scale from 0 (not at all) to 3 (very much, very frequently). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.|Baseline and up to 10 weeks|FAS||T-scores||Standard Error|Least Squares Mean
816294|NCT01107418|Primary|Time to Reach Maximum Plasma Concentration (Tmax) of Vemurafenib on Day 9||Pre-dose, 1, 2, 4, 5, 8 hours post-dose on Day 9|PK population. Here, number of participants analyzed signifies participants evaluable for this outcome.||hours||Full Range|Median
824837|NCT01178268|Secondary|Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI||6 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
816247|NCT01101022|Secondary|Change From Baseline in Conner's Adult ADHD Rating Scale-Observer: Short Version (CAARS-O:S) ADHD Index T-score at up to 10 Weeks|The CAARS-O:S is an assessment tool with prompts provided to an observer who describes ADHD-related symptoms in an adult subject. The 26-item scale is scored on a 4-point scale from 0 (not at all) to 3 (very much, very frequently). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.|Baseline and up to 10 weeks|FAS||T-scores||Standard Error|Least Squares Mean
816248|NCT01101022|Secondary|Change From Baseline in AIM-A Quality of Life Questions 1 and 4 Scores at up to 10 Weeks|"Question 1: 'On a scale of 1 to 10, how would you rate the overall quality of life right now?' It is rated on a scale of 1 (worst) to 10 (best). Higher scores representing a more positive rating.
Question 4: 'How much do you agree with this statement: Over the past few weeks, I've had more good days than bad days?' This is rated on a scale of 1 (strongly agree) to 5 (strongly disagree). Lower scores represent better quality of life."|Baseline and up to 10 weeks|FAS||Scores on a scale||Standard Error|Least Squares Mean
816249|NCT01101022|Secondary|Change From Baseline in AIM-A Multi-Item Scales of Living With ADHD and General Well-being Score at up to 10 Weeks|The AIM-A was developed to assess impact of core ADHD symptoms on daily functioning and quality of life. For multi-item scales, subjects respond to items using a Likert scale with responses ranging from 1 (strongly agree) to 5 (strongly disagree). Scores were computed by deriving the mean of the item sets and transforming the scale score on a continuum from 0 to 100 using a standard formula. Higher scores indicate a better quality of life.|Baseline and up to 10 weeks|FAS||Scores on a scale||Standard Error|Least Squares Mean
816250|NCT01101022|Secondary|Percent of Participants With Improvement on Clinical Global Impression - Global Improvement (CGI-I) at up to 10 Weeks|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|Up to 10 weeks post-dose|FAS||Percent of participants|||Number
816251|NCT01101022|Secondary|Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at up to 10 Weeks|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|Up to 10 weeks post-dose|FAS||Percent of participants|||Number
816252|NCT01101022|Secondary|Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|Baseline|FAS||Percent of participants|||Number
816253|NCT01101022|Secondary|Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) With Adult Prompts Total Score at up to 10 Weeks|The ADHD-RS consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. Lower scores indicate reduction in symptoms.|Baseline and up to 10 weeks|FAS||Scores on a scale||Standard Error|Least Squares Mean
816254|NCT01101022|Secondary|Change From Baseline in Informant-reported BRIEF-A Clinical Subscales T-scores at up to 10 Weeks|BRIEF-A clinical subscales items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.|Baseline and up to 10 weeks|FAS||T-scores||Standard Error|Least Squares Mean
816255|NCT01101022|Secondary|Change From Baseline in Subject-reported BRIEF-A Clinical Subscales T-scores at up to 10 Weeks|BRIEF-A clinical subscales items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.|Baseline and up to 10 weeks|FAS||T-scores||Standard Error|Least Squares Mean
816256|NCT01101022|Secondary|Change From Baseline in Subject-reported BRIEF-A T-scores at up to 10 Weeks|BRIEF-A is a validated 75-item questionnaire composed of three indexes (Global Executive Composite, Behavioral Recognition Index, and Metacognition Index). Global Executive Composite was reported as the Primary Outcome. Items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.|Baseline and up to 10 weeks|FAS||T-scores||Standard Error|Mean
816257|NCT01101022|Secondary|Change From Baseline in Informant-reported BRIEF-A T-scores at up to 10 Weeks|BRIEF-A is a validated 75-item questionnaire composed of three indexes (Global Executive Composite, Behavioral Recognition Index, and Metacognition Index). Items are rated 1 (never), 2 (sometimes), and 3 (often). Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.|Baseline and up to10 weeks|FAS||T-scores||Standard Error|Least Squares Mean
816258|NCT01101022|Secondary|Change From Baseline in Adult ADHD Impact Module (AIM-A) Multi-Item Scales Total Score at up to 10 Weeks|The AIM-A was developed to assess impact of core ADHD symptoms on daily functioning and quality of life. For multi-item scales, subjects respond to items using a Likert scale with responses ranging from 1 (strongly agree) to 5 (strongly disagree). Scores were computed by deriving the mean of the item sets and transforming the scale score on a continuum from 0 to 100 using a standard formula. Higher scores indicate a better quality of life.|Baseline and up to 10 weeks|FAS||Scores on a scale||Standard Error|Least Squares Mean
816259|NCT01101022|Primary|Change From Baseline in Subject-reported Behavior Rating Inventory of Executive Function - Adult Version Global Executive Composite T-score (BRIEF-A GEC T) at up to 10 Weeks|BRIEF-A Global Executive Composite assesses behavioral aspects of executive function. Items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.|Baseline and up to 10 weeks|Full Analysis Set (FAS) defined as all subjects who took 1 dose of investigational product in the double-blind evaluation phase and had 1 primary efficacy assessment.||T-scores||Standard Error|Least Squares Mean
816260|NCT01107197|Secondary|the Percentage of Change in Area|the reduction in ulcer area (%) observed at 4 weeks|4 weeks of nutritional support (baseline and week 4)|||percent change||Inter-Quartile Range|Median
816261|NCT01107197|Secondary|Dressings|The number of dressings used throughout the intervention period|8 weeks of nutritional support (baseline and week 8)|||dressings||Standard Deviation|Mean
816295|NCT01107418|Primary|Maximum Plasma Concentration (Cmax) of Vemurafenib on Day 9||Pre-dose, 1, 2, 4, 5, 8 hours post-dose on Day 9|PK population. Here, number of participants analyzed signifies participants evaluable for this outcome.||mcg/mL||Standard Deviation|Mean
816262|NCT01107197|Secondary|Cost-effectiveness|Incremental cost-effectiveness ratio (ICER) was calculated by dividing the difference between total costs (active – control) by the difference in the mean reduction (%) of ulcer area. Costs are derived from oral nutritional supplements, dressings, antibiotics, PU swab sampling, nurse visits for wound dressing (according to their duration and cost per hour), medical consultations (unitary cost of the visit for prescription of antibiotic therapy).|8 weeks of nutritional support (baseline and week 8)|||Euros||Standard Deviation|Mean
816263|NCT01107197|Secondary|Incidence of Infections|defined as local (ulcer)|8 weeks of nutritional support (baseline and week 8)|||participants|||Number
816264|NCT01107197|Secondary|Rate of Healing|complete healing|8 weeks of nutritional support (baseline and week 8)|||participants|||Number
816265|NCT01107197|Secondary|Rate of Healing|reduction in ulcer area >=40%|8 weeks of nutritional support (baseline and week 8)|||participants|||Number
816266|NCT01107197|Primary|Rate of Healing|healing is defined as reduction in ulcer area (the percentage of change)|8 weeks of nutritional support (baseline and week 8)|||percent change||Standard Deviation|Mean
816267|NCT01107353|Primary|Bioequivalence Determined by Statistical Comparison Cmax|Blood samples were collected pre-dose and at intervals over 120 hours after each dose|33 Days|||ng/mL||Standard Deviation|Mean
816268|NCT01107379|Primary|Mean Intra-patient Change in Lund-Mackay CT Scan Score|"Change in Lund-Mackay CT score for paired baseline and 24 week data.
The Lund-MacKay (LMK) CT (computed tomography) score is a scoring system to evaluate radiographic opacification of the paranasal sinuses. The LMK score will be evaluated at 24 weeks post-procedure compared to baseline. The LMK scoring system rates each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses on a scale of 0 to 2, where '0' is 'no opacification' and '2' is 'complete opacification'. The scores for a given subject are totaled and expressed as the LMK score, where zero is the minimum score, and 24 is the maximum score. A higher score represents greater sinus disease burden."|Baseline and 24 weeks|The 24 week follow-up was optional for 83 of the 203 enrolled subjects. Additionally, for those who were expected per protocol to return for the 24 week follow-up, not all did return so that data could be collected. Data are available for 111 subjects.||Scores on a scale||Standard Deviation|Mean
816269|NCT01107379|Secondary|Mean Number of Days to Return to Normal Activities|Quality Of Life (QoL) evaluated by analysis of time to return to usual activities of daily living|2 weeks|Not all subjects were compliant with reporting the Number of Days to Return to Normal Activities post procedure. Data are available for 181 subjects.||days||Standard Deviation|Mean
816270|NCT01107379|Secondary|Proportion of Sinuses Successfully Treated in the Absence of Serious, Procedural Adverse Events.|Procedure success is defined as achievement of the goal of the treatment. The physician will determine procedure success by visual endoscopic exam and absence of serious, procedural adverse events.|Day 0 (Day of Procedure)|||number of sinuses|Participants||Number
816271|NCT01107379|Secondary|Proportion of Sinuses Successfully Treated in the Office Using Balloon Catheter Tools and Traditional Endoscopic Tools as Necessary|Technical success of the procedure is defined as successful treatment of sinuses intended for treatment in the office, using balloon catheter tools and traditional endoscopic tools, as necessary|Day 0 (Day of Procedure)|||number of sinuses|Participants||Number
816272|NCT01107379|Secondary|Procedure Tolerability|Procedure Tolerability: Proportion of Subjects rating procedure as tolerable or highly tolerable.|Day 0 (Day of Procedure)|Not all subjects were compliant will filling out tolerability questionnaires. Data are available for 198 subjects.||number of participants|||Number
816273|NCT01107379|Primary|Mean Intra-patient Change in SNOT-20 Score|"Change in patient-reported quality of life survey, Sino-Nasal Outcome Test -20 (SNOT-20), using paired baseline and 24 week data.
The 20 question Sino-Nasal Outcome Test (SNOT-20) will be used to evaluate sinus symptoms and sinus-symptom related quality of life (QOL) at baseline and 24 weeks post-procedure. The change in SNOT-20 score at 24 months will be compared to the baseline SNOT-20 score. Each of the 20 questions in the SNOT-20 survey is scored on a scale of 0 to 5, where '0' represents 'no problem' and '5' represents 'problem as bad as it can be'. The 20 questions are expressed as a mean of the scores. Therefore, the minimum mean score is zero and the maximum mean score is 5."|Baseline and 24 weeks|The 24 week follow-up was optional for 83 of the 203 enrolled subjects. Additionally, for those who were expected per protocol to return for the 24 week follow-up, not all did return so that data could be collected. Data are available for 113 subjects.||Scores on a scale||Standard Deviation|Mean
816274|NCT01107392|Secondary|Duration of Effect|Duration of effect was calculated from the time of the first follow-up visit with a ≥ 4-point reduction from Baseline in IPSS to the next visit when the IPSS change from Baseline was < 4-points.|24 Weeks|Modified Intent-to-treat population included all randomized and treated patients with at least one post-baseline IPSS measurement. Only patients with at least a 4-point reduction from Baseline in total IPSS were included in the analysis.||Weeks||95% Confidence Interval|Median
816275|NCT01107392|Secondary|Change From Baseline in Peak Urine Flow Rate|Urinary flow was determined by uroflowmetry measured in milliliters/second (mL/sec). An increase from Baseline indicated improvement.|Baseline, Weeks 6, 12 and 24|Modified Intent-to-treat population included all randomized and treated participants with at least one post-baseline IPSS measurement with data available for this outcome measure.||mL/sec||Standard Deviation|Mean
816276|NCT01107392|Secondary|Change From Baseline in the Total International Prostate Symptom Score (IPSS)|IPSS is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consisted of seven items. The patient evaluated their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score ranged from 0 (no symptoms) to 35 (most severe symptoms). A negative change from Baseline indicated improvement.|Baseline, Week 6, Week 24|Modified Intent-to-treat population included all randomized and treated participants with at least one post-baseline IPSS measurement.||Score on a scale||Standard Deviation|Mean
816296|NCT01107418|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to 8 Hours (AUC[0-8h]) of Vemurafenib on Day 9||Pre-dose, 1, 2, 4, 5, 8 hours post-dose on Day 9|PK population. Here, number of participants analyzed signifies participants evaluable for this outcome.||mcg*h/mL||Standard Deviation|Mean
816297|NCT01107418|Primary|Time to Reach Maximum Plasma Concentration (Tmax) of Vemurafenib on Day 1||Pre-dose, 1, 2, 4, 5, 8 hours post-dose on Day 1|PK population.||hours||Full Range|Median
816277|NCT01107392|Primary|Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Week 12|IPSS is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consisted of seven items. The patient evaluated their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score ranged from 0 (no symptoms) to 35 (most severe symptoms). A negative change from Baseline indicated improvement.|Baseline, Week 12|Modified Intent-to-treat population included all randomized and treated participants with at least one post-baseline IPSS measurement.||Score on a scale||Standard Deviation|Mean
816278|NCT01107405|Secondary|Conjunctival Redness|Evaluated by investigator at 7, 15 and 20 minutes post challenge on a scale of 0-4 where 0= no redness and 4=extremely severe redness.|Visit 4 (initial challenge)|Visit 4 Conjunctival Hyperemia Scores – ITT Population with LOCF included data from all randomized subjects who received treatment and had at least 1 post-CAC assessment.||units on a scale||Standard Deviation|Mean
816279|NCT01107405|Secondary|Ocular Itching|Evaluated by the subject at 3, 5 and 7 min post-challenge on a scale of 0-4 where 0=no itching and 4=incapacitating itch.|Visit 4 (initial challenge)|Visit 4 Ocular Itching Scores – ITT Population with LOCF included data from all randomized subjects who received treatment and had at least 1 post-CAC assessment.||units on a scale||Standard Deviation|Mean
816280|NCT01107405|Secondary|Conjunctival Redness|Evaluated by investigator at 7, 15 and 20 minutes post challenge on a scale of 0-4 where 0= no redness and 4=extremely severe redness.|Visit 3 (initial challenge)|Visit 3 Conjunctival Hyperemia Scores – ITT Population with LOCF included data from all randomized subjects who received treatment and had at least 1 post-CAC assessment.||units on a scale||Standard Deviation|Mean
816281|NCT01107405|Secondary|Ocular Itching|Evaluated by the subject at 3, 5 and 7 min post-challenge on a scale of 0-4 where 0=no itching and 4=incapacitating itch.|Visit 3 (initial challenge)|Visit 3 Ocular Itching Scores – ITT Population with LOCF included data from all randomized subjects who received treatment and had at least 1 post-CAC assessment.||units on a scale||Standard Deviation|Mean
816282|NCT01107405|Primary|Conjunctival Redness|Evaluated by investigator at 7, 15 and 20 minutes post challenge on a scale of 0-4 where 0= no redness and 4=extremely severe redness.|Visit 4 (8 hr re-challenge)|Visit 4, Re-challenge Conjunctival Hyperemia Scores, ITT Population with LOCF included data from all randomized subjects who received treatment and had at least 1 post-CAC assessment.||Units on a scale||Standard Deviation|Mean
816283|NCT01107405|Primary|Ocular Itching|Evaluated by subject at 3, 5, and 7 min post challenge on a scale of 0-4 where 0=no itching and 4=incapacitating itch.|Visit 4 (8 hr re-challenge)|Visit 4, Re-challenge Ocular Itching Scores – Primary Analysis ITT Population with LOCF included data from all randomized subjects who received treatment and had at least 1 post-CAC assessment.||Units on a Scale||Standard Deviation|Mean
816284|NCT01107418|Primary|Accumulation Ratio of Vemurafenib on Day 15|Accumulation ratio was calculated as, AUC(0-8) on Day 15 divided by AUC(0-8) on Day 1.|Pre-dose, 1, 2, 4, 5, 8 hours post-dose on Day 1 and 15|PK population. Here, number of participants analyzed signifies participants evaluable for this outcome.||ratio||Standard Deviation|Mean
816285|NCT01107418|Secondary|Overall Survival (OS)|OS was defined as the time, in months, from the date of the first study drug administration to the date of death, regardless of the cause of death.|Up to approximately 3 years (assessed at Cycle 1 Day 1, Cycle 3 Day 1, Cycle 5 Day 1, thereafter every 2 cycles and then every 4 cycles after Cycle 13)|Data for this outcome measure was not collected as the outcome was removed as per changes in planned analysis (protocol amendment).|||||
816286|NCT01107418|Secondary|Percentage of Participants With a Confirmed Best Overall Response of Complete Response (CR) or Partial Response (PR)|Confirmed best overall response was defined as having best objective response as CR or PR, as assessed by investigator and confirmed at least 28 days after initial response. Tumor response was assessed according to the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1). CR was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) were required to demonstrate a reduction to normal (short axis less than [<] 10 millimeters [mm]). PR was defined as a 30 percent (%) decrease in the sum of the diameters of the target lesions taking as a reference the baseline sum diameter. Percentage of participants with best overall response of confirmed CR or PR are reported.|Up to approximately 3 years (assessed at Cycle 1 Day 1, Cycle 3 Day 1, Cycle 5 Day 1, thereafter every 2 cycles and then every 4 cycles after Cycle 13)|Efficacy population: all enrolled participants who received at least one dose of vemurafenib, had measurable target lesions at baseline based on RECIST 1.1 criteria, had no major protocol violations of inclusion/exclusion criteria, and had no other violations affecting efficacy assessments.||percentage of participants|||Number
816287|NCT01107418|Primary|Terminal Elimination Half-Life (t1/2) of Vemurafenib on Day 15|Time measured for vemurafenib plasma concentrations to decrease by one-half (t1/2) was calculated as 0.693 divided by apparent first-order terminal elimination rate constant (0.693/kel).|Pre-dose, 1, 2, 4, 5, 8, 24, 28, 72, 76, 168 hours post-dose on Day 15|PK population. Here, number of participants analyzed signifies participants evaluable for this outcome.||hours||Standard Deviation|Mean
816288|NCT01107418|Primary|Apparent Clearance (CL/F) of Vemurafenib on Day 15|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.|Pre-dose, 1, 2, 4, 5, 8, 24, 28, 72, 76, 168 hours post-dose on Day 15|PK population. Here, number of participants analyzed signifies participants evaluable for this outcome.||liters/hour (L/h)||Standard Deviation|Mean
816289|NCT01107418|Primary|Time to Reach Maximum Plasma Concentration (Tmax) of Vemurafenib on Day 15||Pre-dose, 1, 2, 4, 5, 8, 24, 28, 72, 76, 168 hours post-dose on Day 15|PK population. Here, number of participants analyzed signifies participants evaluable for this outcome.||hours||Full Range|Median
816290|NCT01107418|Primary|Maximum Plasma Concentration (Cmax) of Vemurafenib on Day 15||Pre-dose, 1, 2, 4, 5, 8, 24, 28, 72, 76, 168 hours post-dose on Day 15|PK population. Here, number of participants analyzed signifies participants evaluable for this outcome.||mcg/mL||Standard Deviation|Mean
816291|NCT01107418|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to 168 Hours (AUC[0-168h]) of Vemurafenib on Day 15||Pre-dose, 1, 2, 4, 5, 8, 24, 28, 72, 76, 168 hours post-dose on Day 15|PK population. Here, number of participants analyzed signifies participants evaluable for this outcome.||mcg*h/mL||Standard Deviation|Mean
816301|NCT01107457|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI)|"The DLQI is a 10-item, participant-administered dermatology-specific questionnaire that assess health related quality of life that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The DLQI items response categories are scored 0 (not relevant) to 3 (very much) with a total score range of 0 to 30; higher scores indicate poor quality of life and a 5-point change from baseline is considered clinically relevant.
Baseline is defined as the last available value prior to the first dose in Part A of the study."|Baseline Up to 240 Weeks|All enrolled participants who had PASI 75 response at Week 20.||units on a scale||Standard Deviation|Mean
816302|NCT01107457|Secondary|Percentage of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement|PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (none) to 4 (very severe). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor (head [0.1], upper limbs [0.2], trunk [0.3], lower limbs [0.4]). Overall scores range from 0 (no psoriasis) to 72 (the most severe disease).Participants achieving PASI 75 were defined as having an improvement of ≥75% in the PASI score compared to baseline.|Week 240|All enrolled participants who had PASI 75 response at Week 20.||percentage of participants|||Number
816303|NCT01107457|Secondary|Change From Baseline up to 240 Weeks in Palmoplantar Psoriasis Severity Index (PPASI) in Participants With Palmoplantar Psoriasis|The PPASI is a physician-assessed composite score derived from the summed scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement. The PPASI score ranges from 0 to 72, with higher scores representing greater severity of palmoplantar psoriasis.LS mean was calculated using MMRM with baseline score as covariate, visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to symmetric.|Baseline Up to 240 Weeks|All enrolled participants with baseline palmoplantar psoriasis.||units on a scale||Standard Deviation|Mean
816304|NCT01107457|Secondary|Change From Baseline up to 240 Weeks in Scalp Psoriasis Severity Index (PSSI) in Participants With Scalp Psoriasis|"The PSSI is a physician-assessed composite score derived from the summed scores for erythema, induration, and desquamation multiplied by a score for the extent of scalp area involved. The PSSI score ranges from 0 to 72, with higher scores representing greater severity of scalp psoriasis.
Baseline is defined as the last available value prior to the first dose in Part A of the study."|Baseline Up to 240 Weeks|All enrolled participants with baseline scalp psoriasis.||units on a scale||Standard Deviation|Mean
816305|NCT01107457|Secondary|Change From Baseline up to 240 Weeks in Nail Psoriasis Severity Index (NAPSI) in Participants With Nail Psoriasis|"The NAPSI is physician-rated and quantifies the severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix and nail bed. Each finger nail is divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). Participant's fingers and toes were evaluated and the sum of the scores was added resulting in a range of 0 to 160; higher scores indicate greater severity. If an individual toe or finger assessment was missing (not done), the average of the remaining measured digits was imputed and added to the sum. If <50% of the toes or finger assessments were missing, the imputation was performed. If >50% of the assessments were missing, then the sum of the scores was left as missing.
Baseline is defined as the last available value prior to the first dose in Part A of the study."|Baseline Up to 240 Weeks|All enrolled participants with baseline nail psoriasis.||units on a scale||Standard Deviation|Mean
816306|NCT01107457|Secondary|Change From Baseline in Pain Visual Analog Scale (VAS)|The pain VAS is a participant-administered single-item scale designed to measure current joint pain from psoriatic arthritis (PsA) using a 100- millimeter (mm) horizontal VAS. Overall severity of participant's joint pain from PsA is indicated by placing a single mark on the horizontal 100-mm scale from 0mm (no pain) to 100 mm (pain as severe as you can imagine). A mixed effects model for repeated measures analysis was used.|Baseline Up to 240 Weeks|All enrolled participants with data available.||Millimeters (mm)||Standard Error|Mean
816307|NCT01107457|Secondary|Number of Participants With Patient's Global Assessment of Disease Activity (PatGA)|"The PatGA is a single-item self-reported instrument asking the participant to rate the severity of their psoriasis today by circling a number on the numeric rating scale from 0 (Clear = no psoriasis) to 5 (Severe = the worst their psoriasis has ever been)."|Week 240|All enrolled participants who had PASI 75 response at Week 20.||Participants|||Count of Participants
816308|NCT01107457|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale (HADS)|The HADS is a 14-item, participant self-reported scale that consists of an anxiety scale and a depression scale, each with 7 items. Items are rated on a 4-point Likert-type scale ranging from 0 (low level of anxiety or depression) to 3 (high level of anxiety or depression). Each subscale score ranges from 0 to 21 with higher scores indicating greater symptom severity. The classification is defined: 0-7 normal, 8-10 Borderline, 11-21 Abnormal.|Baseline Up to 240 Weeks|All enrolled participants who had PASI 75 response at Week 20.||units on a scale||Standard Deviation|Mean
816309|NCT01107457|Secondary|Number of Treatment Emergent Adverse Events up to 344 Weeks|Treatment-emergent adverse events (TEAEs) are events which were not present at baseline or pre-existing conditions at baseline that worsened in severity following the start of treatment. A summary of other non-serious Adverse Events (AEs), and all Serious Adverse Events (SAE's), regardless of causality, is located in the Reported Adverse Events section.|Baseline Up to 344 Weeks|All enrolled participants.||Participants|||Count of Participants
816310|NCT01107457|Secondary|Percentage of Participants With Static Physician's Global Assessment (sPGA) of (0,1)|The sPGA of psoriasis is scored on a 6-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 6-point severity scale (0 [clear] to 5 [severe]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the sPGA score and category (0=clear; 1=minimal; 2=mild; 3=moderate; 4=marked; 5 = severe). As defined by protocol, a responder is a participant who has a post-baseline sPGA score of '0' or a post-baseline score of '1' with at least a 2 point improvement from baseline.|Baseline Up to 240 Weeks|All enrolled participants who had PASI 75 response at Week 20.||percentage of participants|||Number
816311|NCT01107457|Secondary|Percentage of Participants With Anti-Ixekizumab Antibodies|Percentage of participants with treatment-emergent positive anti-ixekizumab antibodies was summarized by treatment group. Percentage was calculated based on the number of evaluable participants and was calculated by number of participants with treatment-emergent positive anti-ixekizumab antibodies / number of evaluable participants * 100%.|Baseline through Week 20|All randomized participants who received at least one dose of study drug and had a baseline and at least one post-baseline antibody assessment.||percentage of participants|||Number
816312|NCT01107457|Secondary|Percentage of Participants With a Static Physician's Global Assessment (sPGA) Score of Cleared (0) or Minimal (1) With at Least a 2 Point Improvement|The sPGA of psoriasis is scored on a 6-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 6-point severity scale (0 [clear] to 5 [severe]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the sPGA score and category (0=clear; 1=minimal; 2=mild; 3=moderate; 4=marked; 5 = severe). As defined by protocol, a responder is a participant who has a post-baseline sPGA score of '0' or a post-baseline score of '1' with at least a 2 point improvement from baseline.|Week 32|All randomized participants who received at least 1 dose of study drug, completed study treatment in Part A, achieved PASI 75 at Week 20 and who were followed for treatment durability up to Week 32. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values. Zero participants in the placebo arm had data.||percentage of participants|||Number
816313|NCT01107457|Secondary|Percentage of PASI Improvement From Baseline Through 32 Weeks|The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (none) to 4 (very severe). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor (head [0.1], upper limbs [0.2], trunk [0.3], lower limbs [0.4]). Overall scores range from 0 (no psoriasis) to 72 (the most severe disease). Improvement in PASI is defined as improvement in the PASI calculated score at a visit as compared to the score calculated at the baseline visit.|Baseline Through 32 Weeks|All randomized participants who received at least 1 dose of study drug, completed study treatment in Part A, achieved PASI 75 at Week 20 and who were followed for treatment durability up to Week 32. Zero participants in the placebo arm had data.||Percentage PASI improvement||Standard Deviation|Mean
816314|NCT01107457|Secondary|Percentage of Participants Who Achieve a 75% Improvement in the Psoriasis Area and Severity Index (PASI 75)|PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (none) to 4 (very severe). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor (head [0.1], upper limbs [0.2], trunk [0.3], lower limbs [0.4]). Overall scores range from 0 (no psoriasis) to 72 (the most severe disease). Participants achieving PASI 75 were defined as having an improvement of ≥75% in the PASI score compared to baseline.|Week 32|All randomized participants who received at least 1 dose of study drug, completed study treatment in Part A, achieved PASI 75 at Week 20 and who were followed for treatment durability up to Week 32. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.||percentage of participants|||Number
816315|NCT01107457|Secondary|Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12|PASI combines the extent of body surface involvement in 4 anatomical regions(head,trunk,arms,and legs).For each region the percent area of skin involved was estimated from 0(0%) to 6(90%-100%) and severity was estimated by clinical signs of erythema,induration and scaling with a scores range from 0(none) to 4(very severe).Each area is scored by itself and the scores were then combined for the final PASI.Final PASI calculated as:sum of severity parameters for each region*area score*weighing factor (head[0.1],upper limbs[0.2],trunk[0.3],lower limbs [0.4]).Overall scores range from 0(no psoriasis) to 72(most severe disease).The LS mean are presented for each treatment versus placebo comparison at each visit and use ANCOVA model including baseline PASI covariate and treatment as fixed effect in the model.Results at Week 12 are summarized as Improvement in PASI which is defined as a reduction in the PASI calculated score at a visit as compared to the score calculated at the baseline visit.|Baseline, Week 12|All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.||units on a scale||Standard Error|Least Squares Mean
816316|NCT01107457|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Total Score at Week 16|The DLQI is a 10-item, participant-administered dermatology-specific questionnaire that assess health related quality of life that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The DLQI items response categories are scored 0 (not relevant) to 3 (very much) with a total score range of 0 to 30; higher scores indicate poor quality of life and a 5-point change from baseline is considered clinically relevant. The LS Mean(no multiplicity adjustments) are presented for each treatment versus placebo comparison at each visit and use an analysis of covariance (ANCOVA) model including baseline as a covariate and treatment as fixed effect in the model.|Baseline, Week 16|All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.||units on a scale||Standard Error|Least Squares Mean
816317|NCT01107457|Secondary|Ixekizumab Systemic Clearance (CL) (Serum Concentrations of Ixekizumab From Baseline Through 32 Weeks)|The population pharmacokinetic (PK) modeling value for systemic clearance was based on data from week 1 to week 32 for all participants in all ixekizumab treatment arms.|Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28 and Week 32|All randomized participants who received at least 1 dose of study drug and had evaluable PK data.||liters per hour (L/hr)||95% Confidence Interval|Mean
816491|NCT01108835|Secondary|Quality of Life|Measured by change in St. George Respiratory Questionnaire (SGRQ) total score from baseline to 12 month. SGRQ total score ranged from 0-100. The change was calculated by the 12 month SGRQ total score minus the baseline value. Negative values indicated improvement in quality of life.|12 months|||units on a scale||Standard Deviation|Mean
816318|NCT01107457|Secondary|Change From Baseline in Scalp Psoriasis Severity Index (PSSI) in Participants With Scalp Psoriasis at Week 12|The PSSI is a physician-assessed composite score derived from the summed scores for erythema, induration, and desquamation multiplied by a score for the extent of scalp area involved. The PSSI score ranges from 0 to 72, with higher scores representing greater severity of scalp psoriasis.LS mean was calculated using MMRM with baseline score as covariate, visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured.|Baseline, Week 12|All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Only participants with baseline scalp involvement were included in the analysis.||units on a scale||95% Confidence Interval|Least Squares Mean
816319|NCT01107457|Secondary|Change From Baseline in Palmoplantar Psoriasis Severity Index (PPASI) in Participants With Palmoplantar Psoriasis at Week 12|The PPASI is a physician-assessed composite score derived from the summed scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement. The PPASI score ranges from 0 to 72, with higher scores representing greater severity of palmoplantar psoriasis.LS mean was calculated using MMRM with baseline score as covariate, visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to symmetric.|Baseline, Week 12|All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Only participants with palmoplantar involvement were included in the analysis.||units on a scale||95% Confidence Interval|Least Squares Mean
816320|NCT01107457|Secondary|Change From Baseline in Nail Psoriasis Severity Index (NAPSI) in Participants With Nail Psoriasis at Week 12|The NAPSI is physician-rated and quantifies the severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix and nail bed. Each finger nail is divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). Participant's fingers and toes were evaluated and the sum of the scores was added resulting in a range of 0 to 160; higher scores indicate greater severity. If an individual toe or finger assessment was missing (not done), the average of the remaining measured digits was imputed and added to the sum. If <50% of the toes or finger assessments were missing, the imputation was performed. If >50% of the assessments were missing, then the sum of the scores was left as missing. LS mean was calculated using MMRM with baseline score as covariate, visit, treatment and visit by treatment interaction as fixed effects.|Baseline, Week 12|All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Only participants with baseline nail involvement were included in the analysis.||units on a scale||95% Confidence Interval|Least Squares Mean
816321|NCT01107457|Secondary|Change From Baseline in Medical Outcomes Study Short-Form 36 (SF-36) - Physical Component Score (PCS) and Mental Component Score (MCS) at Week 16|The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped into the PCS and MCS scores. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. The recall period was the past 4 weeks. The LS Mean was calculated using ANCOVA model including baseline as a covariate and treatment as fixed effect in the model.|Baseline, Week 16|All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.||units on a scale||Standard Error|Least Squares Mean
816322|NCT01107457|Secondary|Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI Q) at Week 16|The WPAI questionnaire has six questions to assess whether the participant was currently employed (Q1); how many hours from work were missed due to problems associated with psoriasis (Q2) or any other reason (Q3); hours actually worked (Q4); degree that psoriasis affected productivity while working (Q5); and degree that psoriasis affected regular activities (Q6) over the past 7 days. Four separate overall scores were calculated, Absenteeism (work time missed) = (Q2/(Q2+Q4))*100, Presenteeism(impairment at work/reduced on-the-job effectiveness) = (Q5/10) *100, Work productivity loss(overall work impairment /absenteeism plus presenteeism) = (Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))x(Q5/10)]) * 100 and Activity Impairment = (Q6/10) * 100. Each score ranges from 0 to 100 with higher scores indicating greater impairment and less productivity ( worse outcomes). The LS Mean was calculated using ANCOVA model including baseline as a covariate and treatment as fixed effect in the model.|Baseline, Week 16|All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.||units on a scale||Standard Error|Least Squares Mean
816323|NCT01107457|Secondary|Number of Participants Who Received Medical Care Measured by Medical Care Resource Utilization (PMRU))|The PMRU is a 3‑item participant-reported questionnaire on health care resource utilization due to psoriasis for physician/clinic visits, emergency room visits, and inpatient hospital admissions since the last study visit.|Week 16|All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment.||participants|||Number
816324|NCT01107457|Secondary|Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-S) at Week 16|MOS-S provides a concise assessment of important dimensions of sleep, including initiation, maintenance, respiratory problems, quantity, perceived adequacy, and somnolence during the past 4 weeks. Scoring based on 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100,with higher scores for more impairment); sleep quantity (range:0-24), and optimal sleep (yes:1, no:0). Six(6) and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = higher scores indicate greater problems with the attribute.The LS Mean (no multiplicity adjustments) was calculated using an analysis of covariance (ANCOVA) model including baseline as a covariate and treatment as fixed effect in the model.|Baseline, Week 16|All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.||units on a scale||Standard Error|Least Squares Mean
824838|NCT01178268|Secondary|Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI||30 days|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
816325|NCT01107457|Secondary|Change From Baseline in Pain Visual Analog Scale (VAS) at Week 12|The pain VAS is a participant-administered single-item scale designed to measure current joint pain from psoriatic arthritis (PsA) using a 100- millimeter (mm) horizontal VAS. Overall severity of participant's joint pain from PsA is indicated by placing a single mark on the horizontal 100-mm scale from 0mm (no pain) to 100 mm (pain as severe as you can imagine). A mixed effects model for repeated measures analysis was used. Least Squares (LS) Mean values were calculated using MMRM and were controlled for baseline as a covariate, visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured.|Baseline, Week 12|All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Only participants with self-reported psoriatic arthritis at baseline were included in the analysis. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.||millimeter (mm)||95% Confidence Interval|Least Squares Mean
816326|NCT01107457|Secondary|Change From Baseline in Patient Global Assessment (PatGA) at Week 12|"The PatGA is a single-item self-reported instrument asking the participant to rate the severity of their psoriasis today by circling a number on the numeric rating scale from 0 (Clear = no psoriasis) to 5 (Severe = the worst their psoriasis has ever been). The LS Mean (no multiplicity adjustments) are presented for each treatment versus placebo comparison at each visit and use an analysis of covariance (ANCOVA) model including baseline as a covariate and treatment as fixed effect in the model."|Baseline, 12 Weeks|All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.||units on a scale||Standard Error|Least Squares Mean
816327|NCT01107457|Secondary|Change From Baseline in 16-Item Quick Inventory of Depressive Symptoms- Self Rated (QIDS-SR16) Total Score at Week 16|The QIDS-SR16 is a self-administered, 16-item instrument in which a participant is asked to consider each statement as it relates to the way they have felt for the past 7 days. There is a 4-point scale for each item ranging from 0 (best) to 3 (worst). The 16 items are scored to give 9 individual depression domains (sad mood, concentration, self-criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance [initial, middle and late insomnia or hypersomnia], decrease/increase in appetite/weight, and psychomotor agitation/retardation), which are summed to give a single score ranging from 0 to 27, with higher scores denoting greater symptom severity. The LS Mean (no multiplicity adjustments) are presented for each treatment versus placebo comparison at each visit and use an analysis of covariance (ANCOVA) model including baseline as a covariate and treatment as fixed effect in the model.|Baseline, Week 16|All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.||units on a scale||Standard Error|Least Squares Mean
816328|NCT01107457|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score at Week 16|The HADS is a 14-item, participant self-reported scale that consists of an anxiety scale and a depression scale, each with 7 items. Items are rated on a 4-point Likert-type scale ranging from 0 (low level of anxiety or depression) to 3 (high level of anxiety or depression). Each subscale score ranges from 0 to 21 with higher scores indicating greater symptom severity. The classification is defined: 0-7 normal, 8-10 Borderline, 11-21 Abnormal. LS mean was calculated using the analysis of covariance (ANCOVA) model including treatment as fixed effect and baseline as covariate.|Baseline, Week 16|All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.||units on a scale||Standard Error|Least Squares Mean
816329|NCT01107457|Secondary|Number of Participants With Treatment Emergent Adverse Events Up to 20 Weeks|Treatment-emergent adverse events (TEAEs) are events which were not present at baseline or pre-existing conditions at baseline that worsened in severity following the start of treatment. A summary of other non-serious Adverse Events (AEs), and all Serious Adverse Events (SAE's), regardless of causality, is located in the Reported Adverse Events section.|Baseline Up to 20 Weeks|All randomized participants who received at least 1 dose of study drug.||Participants|||Number
816330|NCT01107457|Secondary|"Percentage of Participants With a Static Physician's Global Assessment (sPGA) Score of Cleared (0) or Minimal (1) With at Least a 2 Point Improvement at Week 12"|The sPGA of psoriasis is scored on a 6-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 6 point severity scale (0 [clear] to 5 [severe]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the sPGA score and category (0=clear; 1=minimal; 2=mild; 3=moderate; 4=marked; 5 = severe). As defined by protocol, a responder is a participant who has a post-baseline sPGA score of '0' or a post-baseline score of '1' with at least a 2 point improvement from baseline.|Week 12|All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.||percentage of participants|||Number
816331|NCT01107457|Primary|Percentage of PASI Improvement From Baseline to 12 Week Endpoint|The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (none) to 4 (very severe). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor (head [0.1], upper limbs [0.2], trunk [0.3], lower limbs [0.4]). Overall scores range from 0 (no psoriasis) to 72 (the most severe disease). Least squares (LS) mean values were calculated using mixed model repeated measures (MMRM) and controlled for baseline as a covariate, visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured.|Baseline to Week 12|All randomized participants who received at least 1 dose of study drug, had at least 1 post-baseline PASI assessment.||Percentage of improvement in PASI score||95% Confidence Interval|Least Squares Mean
816343|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Angina Pectoris -Renal Dysfunction.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Renal Dysfunction is significant risk factor for Angina Pectoris.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Angina Pectoris in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
816332|NCT01107457|Primary|Percentage of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement|PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (none) to 4 (very severe). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor (head [0.1], upper limbs [0.2], trunk [0.3], lower limbs [0.4]). Overall scores range from 0 (no psoriasis) to 72 (the most severe disease).Participants achieving PASI 75 were defined as having an improvement of ≥75% in the PASI score compared to baseline.|Week 12|All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.||percentage of participants|||Number
816333|NCT01107730|Primary|Incidence of Postoperative Atrial Fibrillation|The incidence of postoperative atrial fibrillation in cardiac surgery patients, using 2 different prophylaxis regimens with vitamin C, as compared to placebo.|Within the first 30 days (plus or minus 3 days)|||participants|||Number
816334|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Concomitant Drugs.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Concomitant Drugs is significant risk factor for Hypercholesterolemia or Familial Hypercholesterolemia.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Hypercholesterolemia or Familial Hypercholesterolemia in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
816335|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Complications.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Complications is significant risk factor for Hypercholesterolemia or Familial Hypercholesterolemia.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Hypercholesterolemia or Familial Hypercholesterolemia in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
816336|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Renal Dysfunction.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Renal Dysfunction is significant risk factor for Hypercholesterolemia or Familial Hypercholesterolemia.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Hypercholesterolemia or Familial Hypercholesterolemia in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
816337|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Hepatic Dysfunction.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Hepatic Dysfunction is significant risk factor for Hypercholesterolemia or Familial Hypercholesterolemia.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Hypercholesterolemia or Familial Hypercholesterolemia in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
816338|NCT01107743|Secondary|Risk Factor for the Proportion of Responders of Amlodipine/Atorvastatin Combination Tablets for Hypercholesterolemia or Familial Hypercholesterolemia - Hypercholesterolemia Expression Type.|"Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether Hypercholesterolemia expression type, Ⅰ, Ⅱa, Ⅱb, Ⅲ, Ⅳ, or Ⅴ is significant risk factor for Hypercholesterolemia or Familial Hypercholesterolemia. Hypercholesterolemia expression types are defined by Japan Atherosclerosis Society Guideline for Prevention of Atherosclerosis Cardiovascular Diseases."|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Hypercholesterolemia or Familial Hypercholesterolemia in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
816339|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Age.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether <65 years or >=65 is significant risk factor for Hypercholesterolemia or Familial Hypercholesterolemia.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Hypercholesterolemia or Familial Hypercholesterolemia in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
816340|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Gender.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether male or female is significant risk factor for Hypercholesterolemia or Familial Hypercholesterolemia.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Hypercholesterolemia or Familial Hypercholesterolemia in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
816341|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Angina Pectoris -Concomitant Drugs.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Concomitant Drugs is significant risk factor for Angina Pectoris.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Angina Pectoris in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
816342|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Angina Pectoris -Complications.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Angina Pectoris is significant risk factor for Angina Pectoris.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Angina Pectoris in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
816492|NCT01108835|Primary|Hospital Readmission|To investigate the effectiveness of a comprehensive care programme in reducing hospital admission in COPD patients who have been discharged from hospital for an episode of AECOPD.|12 months|||hospital readmissions||Standard Deviation|Mean
816344|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Angina Pectoris -Hepatic Dysfunction.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Hepatic Dysfunction is significant risk factor for Angina Pectoris.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Angina Pectoris in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
816345|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Angina Pectoris -Angina Pectoris Severity.|"Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether Angina Pectoris functional classification Severity, Class1, Class2, Class3, or Class4 is significant risk factor for Angina Pectoris. Angina Pectoris functional classification Severity is defined by Canadian Cardiovascular Society functional Classification of Angina."|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Angina Pectoris in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
816346|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Angina Pectoris -Age.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether <65 years or >=65 is significant risk factor for Angina Pectoris.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Angina Pectoris in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
816347|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Angina Pectoris -Gender.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether male or female is significant risk factor for Angina Pectoris.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Angina Pectoris in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
816348|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Hypertension -Concomitant Drugs.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Concomitant Drugs is significant risk factor for Hypertension.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Hypertension in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
816349|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Hypertension -Complications.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Complications is significant risk factor for Hypertension.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Hypertension in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
816350|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Hypertension -Renal Dysfunction.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Renal Dysfunction is significant risk factor for Hypertension.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Hypertension in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
816351|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Hypertension -Hepatic Dysfunction.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Hepatic Dysfunction is significant risk factor for Hypertension.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Hypertension in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
816352|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Hypertension -Hypertension Severity.|"Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether Hypertension severity, ClassⅠ, ClassⅡ, or ClassⅢ is significant risk factor for Hypertension. Hypertension severity is defined by Guideline for the Management of hypertension (The Japan Society of Hypertension)."|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Hypertension in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
816353|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Hypertension -Age.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether <65 years or >=65 is significant risk factor for Hypertension.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Hypertension in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
816354|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Hypertension -Gender.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether male or female is significant risk factor for Hypertension.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Hypertension in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
816355|NCT01107743|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Concomitant Drugs.|Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether Concomitant Drugs is significant risk factor.|8 weeks|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.||participants|||Number
816356|NCT01107743|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Complications.|Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Complications is significant risk factor.|8 weeks|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.||participants|||Number
816416|NCT01108185|Secondary|Dyspnoea|Participants were evaluated at Day 0 (Baseline) and 10 to 16 days later (Visit 2). The treating physicians used their clinical judgment to determine the presence of dyspnoea (difficulty breathing) and whether it occurred while resting or after exertion. The number of participants with each type of dyspnoea or with no dyspnoea at Visit 2 is presented.|Day 10 - 16|||Participants|||Number
816357|NCT01107743|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Renal Dysfunction.|Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Renal Dysfunction is significant risk factor.|8 weeks|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.||participants|||Number
816358|NCT01107743|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hepatic Dysfunction.|Number of participants with Treatment Related Adverse Events (TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Hepatic Dysfunction is significant risk factor.|8 weeks|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.||participants|||Number
816359|NCT01107743|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Familial Hypercholesterolemia.|Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Familial Hypercholesterolemia is significant risk factor.|8 weeks|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.||participants|||Number
816360|NCT01107743|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypercholesterolemia Expression Type.|"Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether Hypercholesterolemia expression type, Ⅰ, Ⅱa, Ⅱb, Ⅲ, Ⅳ, or Ⅴ is significant risk factor. Hypercholesterolemia expression types are defined by Japan Atherosclerosis Society Guideline for Prevention of Atherosclerosis Cardiovascular Diseases."|8 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of this drug was confirmed.||participants|||Number
816361|NCT01107743|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypercholesterolemia.|Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Hypercholesterolemia is significant risk factor.|8 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of this drug was confirmed.||participants|||Number
816362|NCT01107743|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Angina Pectoris.|Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Angina pectoris is significant risk factor.|8 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of this drug was confirmed.||participants|||Number
816363|NCT01107743|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypertension Severity.|"Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether Hypertension severity, ClassⅠ, ClassⅡ, or ClassⅢ is significant risk factor. Hypertension severity is defined by Guideline for the Management of hypertension (The Japan Society of Hypertension)."|8 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of this drug was confirmed.||participants|||Number
816364|NCT01107743|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypertension.|Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Hypertension is significant risk factor.|8 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of this drug was confirmed.||participants|||Number
816365|NCT01107743|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Age.|Number of participants with Treatment Related Adverse Events (TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether <65 years or >=65 years is significant risk factor.|8 weeks|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.||participants|||Number
816366|NCT01107743|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Gender.|Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether male or female is significant risk factor.|8 weeks|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.||participants|||Number
816367|NCT01107743|Secondary|Number of Treatment Related Unlisted Adverse Events in Japanese Package Insert.|Adverse events mean all unfavorable events that occur in patients after administration of Caduet, irrespective of causal relationship to Caduet (including clinically problematic abnormal changes in laboratory test values). Number of Treatment Related Adverse Events were evaluated in company with the causal relationship to Caduet. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert.|8 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of this drug was confirmed.||participants|||Number
816368|NCT01107743|Primary|Number of Participants That Responded to Amlodipine/Atorvastatin Treatment With Hypercholesterolemia or Familial Hypercholesterolemia.|The physician performed efficacy evaluations at the end of the observation period (or the time of discontinuing administration), compared with the data before the start of administration of this drug, and entered the results for Hypercholesterolemia or Familial Hypercholesterolemia.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Hypercholesterolemia or Familial Hypercholesterolemia in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
817594|NCT01112670|Other Pre-specified|Atorvastatin Area Under the Plasma Concentration Time Curve (AUC) Over the Dosing Interval (0-24 Hours)||0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose|The population analyzed included participants who completed both periods of the pharmacokinetic crossover study.||ng*h/ml||Standard Deviation|Mean
816369|NCT01107743|Primary|Number of Participants That Responded to Amlodipine/Atorvastatin Treatment With Angina Pectoris.|The physician performed efficacy evaluations at the end of the observation period (or the time of discontinuing administration), compared with the data before the start of administration of this drug, and enteterd the results for Angina Pectoris.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Angina Pectoris in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
816370|NCT01107743|Primary|Number of Participants That Responded to Amlodipine/Atorvastatin Treatment With Hypertension.|The physician performed efficacy evaluations at the end of the observation period (or the time of discontinuing administration), compared with the data before the start of administration of this drug, and entered the results for Hypertension.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Hypertension in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
816371|NCT01107743|Primary|Number of Treatment Related Adverse Events.|Adverse events mean all unfavorable events that occur in patients after administration of Caduet, irrespective of causal relationship to Caduet (including clinically problematic abnormal changes in laboratory test values). Treatment related Adverse Events were evaluated in company with the causal relationship to Caduet.|8 weeks|The safety analysis population consist of the cases that satisfy the participants conditions and in whom administration of this drug was confirmed.||participants|||Number
816372|NCT01107834|Secondary|Myocardial Wall Velocity During Early Diastole|Myocardial wall velocity during early diastolemeasured by tissue Doppler imaging|Baseline|||cm/s||Standard Error|Mean
816373|NCT01107834|Secondary|Early to Late Diastolic Filling Ratio|Early to late diastolic filling ratio measured by tissue Doppler echocardiography|Baseline|||ratio, unitless||Standard Deviation|Mean
816374|NCT01107834|Secondary|Systolic Myocardial Velocity During Systole (S')|Systolic myocardial velocity during systole measured by tissue Doppler echocardiography|Baseline|||cm/s||Standard Deviation|Mean
816375|NCT01107834|Secondary|Global Strain Rate|Myocardial deformation (a measure of heart contractility) measured by speckel tracking echocardiography|Baseline|||percentage of full deformation||Standard Deviation|Mean
816376|NCT01107834|Primary|Fractional Shortening|Fractional shortening measured by M-mode cardiography|Baseline|||percentage of full contraction||Standard Deviation|Mean
816377|NCT01107834|Primary|Left Ventricular Mass Index|left ventricular mass index measured by 2D echocardiography|Baseline|||g/m2||Standard Deviation|Mean
816378|NCT01107886|Secondary|Participants With Event of Death|Participants with event of death. If no event, censoring occurs at the patient withdrawal of consent, or last contact —whichever was later.|Randomization (day 0) up to 2.9 years|Intention To Treat (ITT) analysis of randomized population. Events were adjudicated by the Clinical Event Adjudication Committee.||participants|||Number
816379|NCT01107886|Secondary|Participants With Any Event From the Composite of CV Death, Non-fatal MI, Non-fatal Ischaemic Stroke, Hospitalisation for Heart Failure, Hospitalisation for Unstable Angina Pectoris, or Hospitalisation for Coronary Revascularisation|Participants with CV death, non-fatal MI, non-fatal ischaemic stroke, hospitalisation for heart failure, hospitalisation for unstable angina pectoris, or hospitalisation for coronary revascularisation. If no event, censoring occurs at the patient withdrawal of consent, last contact, or death (when applicable)—whichever was later.|Randomization (day 0) up to 2.9 years|Intention To Treat (ITT) analysis of randomized population. Events were adjudicated by the Clinical Event Adjudication Committee.||participants|||Number
816380|NCT01107886|Primary|Participants With Any Event From the Composite of Cardiovascular Death (CV Death), Non-fatal Myocardial Infarction (MI), or Non-fatal Ischaemic Stroke|Participants with CV death, non-fatal MI or non-fatal ischaemic stroke. If no event, censoring occurs at the patient withdrawal of consent, last contact, or death (when applicable)—whichever was later.|Randomization (day 0) up to 2.9 years|Intention To Treat (ITT) analysis of randomized population. Events were adjudicated by the Clinical Event Adjudication Committee.||participants|||Number
816381|NCT01107899|Secondary|Platelet Function by Multiplate® ADP Test and ADP Test HS|The Multiplate analyzer was used to assess platelet aggregation based on impedance aggregometry in whole blood. After adding 6.4 µM ADP (ADP test) or 6.4 µM ADP plus 9.4 nM PGE1 (ADP test HS), area under the aggregation curve (AUC) were calculated.|24 hours post-loading dose|LD ITT Population: All randomized participants who received an LD with evaluable PD measurements 24 hours post-LD.||aggregation units*minute||Standard Deviation|Mean
816382|NCT01107899|Secondary|Platelet Function by LTA at 5 and 20 μM ADP|MPA to 5 and 20 μM ADP were assessed by LTA.|24 hours post-loading dose|LD ITT population: All randomized participants who received an LD with evaluable PD measurements 24 hours post-LD.||percent aggregation||Standard Deviation|Mean
816383|NCT01107899|Secondary|Mean Number of Days to the Return of Baseline Platelet Function in All Treatment Arms (Adjusted for Level of Inhibition 24 Hrs Post-LD) by Multiplate® ADP Test and ADP Test High Sensitivity (HS)|The Multiplate analyzer was used to assess platelet aggregation based on impedance aggregometry in whole blood. After adding 6.4 µM ADP (ADP test) or 6.4 µM ADP plus 9.4 nM Prostaglandin E1 (PGE1) (ADP test HS), area under the aggregation curve (AUC) was calculated. This outcome measure was not analyzed due to limited sample size.|Up through 11 days|Since this outcome measure was not analyzed due to the limited sample size, zero participants were included in the analysis.||days||Standard Deviation|Mean
816384|NCT01107899|Secondary|Mean Number of Days to the Return of Baseline Platelet Function in All Treatment Arms (Adjusted for Level of Inhibition 24 Hours Post-LD) by LTA (5 and 20 μM ADP)|Maximum platelet aggregation (MPA) to 5 and 20 μM ADP were assessed by LTA. This outcome measure was not analyzed due to limited sample size.|Up through 11 days|Since this outcome measure was not analyzed due to the limited sample size, zero participants were included in the analysis.||days||Standard Deviation|Mean
816417|NCT01108185|Secondary|Dyspnoea|Participants were evaluated at Day 0 (Baseline) and 10 to 16 days later (Visit 2). The treating physicians used their clinical judgment to determine the presence of dyspnoea (difficulty breathing) and whether it occurred while resting or after exertion. The number of participants with each type of dyspnoea or with no dyspnoea at Baseline is presented.|Day 0|The per-protocol population was analyzed.||Participants|||Number
817659|NCT01113580|Secondary|Frequency of Any Solicited Adverse Events (AEs)|The number of participants reporting any solicited AEs.|During the 4 days after vaccination (Day 0 plus 3 days)|The Safety Population comprised all participants who received study vaccine and provided follow-up safety data.||participants|||Number
816385|NCT01107899|Secondary|Extent of Initial Inhibition of Platelet Aggregation to the Return of Baseline Platelet Function: Multiplate® ADP Test and ADP Test High Sensitivity (HS)|Return of baseline platelet function was assessed by Multiplate® ADP test and ADP test High Sensitivity (HS). Multiplate analyzer was used to assess platelet aggregation based on impedance aggregometry in whole blood. The agonist ADP was added to stirred whole blood after dilution (1:2 with 0.9% NaCl solution) in a final concentration of 6.4 µM (ADP Test) or in final concentration of 6.4 µM ADP plus 9.4 nM Prostaglandin E1 (PGE1) (ADPtest HS). Platelet aggregation was continuously recorded for 5 minutes and quantified as area under the aggregation curve (AUC=AU*min) of aggregation units (AU).|Up through 11 days|ITT Washout Population: All randomized participants who received the study drug LD, had an evaluable baseline PD measurement (pre-LD), and had at least 1 evaluable PD measurement post-LD.||Aggregation Units * minutes||90% Confidence Interval|Mean
816386|NCT01107899|Secondary|Extent of Initial Inhibition of Platelet Aggregation on the Return of Baseline Platelet Function: Light Transmission Aggregometry (LTA)|Initial inhibition of platelet aggregation was measured by LTA at 5 and 20 μM ADP. Maximum platelet aggregation (MPA) is reported by day.|Up through 11 days|ITT Washout Population: All randomized participants who received the study drug LD, had an evaluable baseline PD measurement (pre-LD), and had at least 1 evaluable PD measurement post-LD.||percent platelet aggregation||90% Confidence Interval|Mean
816387|NCT01107899|Secondary|Percentage of Poor Pharmacodynamic Responders by Platelet Aggregation at 24 Hours Post-LD|Platelet aggregation was assessed by Accumetrics Verify Now™ P2Y12, and poor responders were those with PRU greater than or equal to 230.|24 hours post-loading dose|LD ITT Population: All randomized participants who received an LD with evaluable PD measurements.||percentage of participants|||Number
816388|NCT01107899|Secondary|Platelet Function 24 Hours Post Loading Dose|PRU was assessed by Accumetrics Verify Now™ P2Y12. PRU represents the rate and extent of ADP-stimulated platelet aggregation.|24 hours post-loading dose|LD ITT population: All randomized participants who received an LD with evaluable PD measurements 24 hours post-LD.||P2Y12 Reaction Units (PRU)||Standard Deviation|Mean
816389|NCT01107899|Secondary|Mean Number of Days to the Return of Baseline Platelet Function in All Treatment Arms (Adjusted for Level of Inhibition 24 Hrs Post-LD) by VN-PRU|PRU was assessed by Accumetrics Verify Now™ P2Y12. PRU represents the rate and extent of adenosine diphosphate (ADP)-stimulated platelet aggregation. This outcome measure was not analyzed due to the limited sample size.|Up through 11 days|Since this outcome measure was not analyzed due to the limited sample size, zero participants were included in the analysis.||days||Standard Deviation|Mean
816390|NCT01107899|Secondary|Effect of Initial Inhibition of Platelet Aggregation on the Day to Return to Baseline Platelet Function: VN-PRU|To show effect of initial inhibition of platelet aggregation as measured by Accumetrics Verify Now™ P2Y12 on the day to return to baseline platelet function, a regression model was fitted with day to return as outcome variable and initial inhibition as fixed effect. Results are reported as the predicted day to return to baseline platelet function by derived VN-PRU percent (%) inhibition at 24 hours post LD. The derived VN-PRU % inhibition is calculated as a percent decrease of PRU from baseline using the following formula: ([PRU at baseline - PRU at 24 hours post LD]/PRU at baseline) x 100%.|Up through 11 days|ITT Washout Population: All randomized participants who received study drug LD, had an evaluable baseline PD measurement (pre-LD), and had at least 1 evaluable PD measurement post-LD. One participant discontinued on Day 3 without returning to baseline and is not included in analysis.||days|||Number
816391|NCT01107899|Secondary|Number of Days to the Return of Baseline Platelet Function Following One Loading Dose (LD)|The return of baseline platelet function following one LD of prasugrel (30 mg or 60 mg) or 600 mg LD of clopidogrel assessed by Verify Now™ P2Y12 Reaction Units (VN-PRU). This outcome measure was not analyzed because it was not appropriate to estimate the days based on the non-inferiority approach due to the limited sample size.|Up through 11 days|Since this outcome measure was not analyzed due to the limited sample size, zero participants were included in the analysis.||days||Standard Deviation|Mean
816392|NCT01107899|Secondary|The Day When the Proportion of Participants Who Return to Baseline Platelet Function in the 30-mg and 60-mg Prasugrel Groups is Similar to the 600-mg Clopidogrel Group at Day 5 and Day 7|The day at which the proportion of participants who return to baseline platelet P2Y12 receptor function in the prasugrel 30 mg and 60 mg LD groups is similar (within 10% absolute difference) to the proportion of subjects who return to baseline platelet P2Y12 receptor function at day 5 and day 7 in the clopidogrel 600 mg LD group, obtained from Kaplan Meier curves for the primary washout population, was to be presented. This outcome measure was not analyzed due to the limited sample size.|Up through 11 days|Since this outcome measure was not analyzed due to the limited sample size, zero participants were included in the analysis.||day|||Number
816393|NCT01107899|Secondary|The Day on Which 50%, 75% and 90% of Subjects Return to Baseline Platelet Function Following a Single LD of 30-mg or 60-mg Prasugrel or 600-mg Clopidogrel|This outcome measure was not analyzed due to the limited sample size.|Up through 11 days|Since this outcome measure was not analyzed due to the limited sample size, zero participants were included in the analysis.||days|||Number
816394|NCT01107899|Primary|Percentage of Participants Returning to Baseline Platelet Function|Participants were classified as having platelet function return to baseline after loading dose (LD) on the first day that P2Y12 Reaction Units (PRU) was no more than 60 PRU below baseline and remained in this range. PRU was assessed by Accumetrics Verify Now™ P2Y12. PRU represents the rate and extent of adenosine diphosphate (ADP)-stimulated platelet aggregation.|Days 3, 5, 7, 9, and 11|Primary Washout Population: Included participants who completed the study, had evaluable pharmacodynamic (PD) data through Day 11. Participants with a missed visit were not included in the Primary Washout Population.||percentage of participants|||Number
816395|NCT01107912|Secondary|Change From Baseline in Maximum Platelet Aggregation (MPA) as Measured by Light Transmission Aggregometry (LTA) From Baseline at Day 12 of Therapy|Maximum Platelet Aggregation (MPA) to 20 μM ADP was assessed by light transmission aggregometry (LTA), an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing the platelet-rich plasma stimulated with a platelet activator, such as ADP, relative to platelet-poor plasma (100% light transmittance). A lower MPA reflects stronger platelet inhibition, whereas a higher MPA reflects weaker inhibition.|Baseline, Day 12|All randomized participants who received at least 1 dose of study drug and provided at least 1 evaluable pharmacodynamic (PD) measure at 1 of the 3 periods. Participants were analyzed based on the treatment they received for each period regardless of their randomized treatment assignment.||percentage of aggregation||Standard Deviation|Mean
816396|NCT01107912|Secondary|Active Metabolite Blood Levels to Drug Exposure as Measured by Pharmacokinetics (PK) Through 4 Hours After Dosing|A descriptive pharmacokinetic-pharmacodynamic (PK-PD) analysis comparing prasugrel and clopidogrel active metabolite exposures to MPA in response to 20 µM ADP (by LTA) was conducted as originally intended; however, the graphic output from that analysis is not possible here. Therefore, the PK portion is presented here as AUC and the PD portion is presented in Secondary Outcome Measure #5. AUC was calculated through the last scheduled sampling time of 4 hours [AUC (0-4)] or through the sampling time of the last quantifiable concentration prior to 4 hours. AUC values were denoted AUC(0-tlast) in both instances.|Baseline up to 4 hours post-dose|All available PK sample data from all treated participants who contributed complete PK profiles.||nanogram*hour/milliliter (ng*hr/mL)|Participants|Geometric Coefficient of Variation|Geometric Mean
816397|NCT01107912|Secondary|Change in VerifyNow P2Y12 Reaction Units (PRU) From Baseline to 12 Days of Therapy|The Accumetrics VerifyNow® P2Y12 assay measures platelet aggregation in whole blood and is reported in P2Y12 reaction units (PRU). PRU report the extent of P2Y12 receptor-mediated platelet aggregation calculated as a function of the rate and extent of platelet aggregation in the presence of adenosine phosphate ADP. A lower PRU reflects stronger inhibition of P2Y12, whereas a higher PRU reflects weaker inhibition of P2Y12.|Baseline, Day 12|All randomized participants who received at least 1 dose of study drug and provided at least 1 evaluable pharmacodynamic (PD) measure at 1 of the 3 periods. Participants were analyzed based on the treatment they received for each period regardless of their randomized treatment assignment.||P2Y12 reaction units (PRU)||Standard Deviation|Mean
816398|NCT01107912|Secondary|Change in Vasodilator-associated Stimulated Phosphoprotein (VASP) From Baseline to 12 Days of Therapy|Vasodilator-associated stimulated phosphoprotein (VASP) phosphorylation levels, expressed as the platelet reactivity index (PRI), reflect the degree of thienopyridine-mediated P2Y12 receptor inhibition. A lower PRI reflects stronger inhibition of P2Y12, whereas a higher PRI reflects weaker inhibition of P2Y12.|Baseline, Day 12|All randomized participants who received at least 1 dose of study drug and provided at least 1 evaluable pharmacodynamic (PD) measure at 1 of the 3 periods. Participants were analyzed based on the treatment they received for each period regardless of their randomized treatment assignment.||percentage platelet reactive index (PRI)||Standard Deviation|Mean
816399|NCT01107912|Primary|Change in Maximum Platelet Aggregation (MPA) to 20 Micromoles (μM) Adenosine Diphosphate (ADP) as Measured by Light Transmission Aggregometry (LTA) From Baseline to 12 Days of Therapy in the First Treatment Period|Maximum Platelet Aggregation (MPA) to 20 μM ADP was assessed by light transmission aggregometry (LTA), an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing the platelet-rich plasma stimulated with a platelet activator, such as ADP, relative to platelet-poor plasma (100% light transmittance). Lower MPA values reflect stronger platelet inhibition, whereas higher MPA values reflect weaker inhibition.|Baseline, 12 days|All randomized participants who continued in the study through the Day 12 visit, and who had at least 1 evaluable PD assessment at the Day 12 visit. Participants were analysed based on randomized treatment assignment, regardless of the study drug they took.||percentage of aggregation||Inter-Quartile Range|Median
816400|NCT01107925|Secondary|Change From Baseline in Maximum Platelet Aggregation (MPA) as Measured by Light Transmission Aggregometry (LTA) at Day 12 of Therapy|MPA to 20 micromolar (μM) adenosine diphosphate (ADP) was assessed by LTA, an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing platelet-rich plasma stimulated with a platelet activator, such as ADP, relative to platelet-poor plasma (100% light transmittance). A lower MPA reflects stronger platelet inhibition, whereas a higher MPA reflects weaker inhibition.|Baseline , Day 12|As-treated pharmacodynamic (PD) population: all randomized participants who received at least 1 dose of study drug and provided at least 1 evaluable PD measure at 1 of the 3 periods. Participants were analyzed based on the treatment they received for each period regardless of their randomized treatment assignment.||percent aggregation||Standard Deviation|Mean
816401|NCT01107925|Secondary|Pharmacokinetic (PK) Analysis of the Concentration-Time Curve (AUC)|A pharmacokinetic-pharmacodynamic (PK-PD) analysis comparing MPA (LTA) and AUC was conducted as originally intended, however the graphic output is not possible here. Therefore, the PK portion is presented here as AUC and the PD portion is presented in Secondary Outcome Measure #5. AUC was calculated through the last scheduled sampling time of 4 hours [AUC (0-4)] or through the sampling time of the last quantifiable concentration prior to 4 hours. AUC values were denoted AUC(0-tlast) in both instances.|baseline (pre-dose) up to 4 hours post-dose|All available PK sample data from all treated participants who contributed complete PK profiles.||nanogram•hour/milliliter (ng•hr/mL)|Participants|Geometric Coefficient of Variation|Geometric Mean
816402|NCT01107925|Secondary|Change From Baseline in VerifyNow® P2Y12 Reaction Units (PRU) at Day 12 of Therapy|The Accumetrics VerifyNow® P2Y12 assay measures platelet aggregation in whole blood and is reported in PRU. PRU indicates the extent of P2Y12 receptor-mediated platelet aggregation calculated as a function of rate and extent of platelet aggregation in an adenosine phosphate (ADP)-containing channel of the device. A lower PRU reflects stronger inhibition of platelet aggregation, whereas a higher PRU reflects weaker inhibition of platelet aggregation.|Baseline, Day 12|As-treated pharmacodynamic (PD) population: all randomized participants who received at least 1 dose of study drug and provided at least 1 evaluable PD measure at 1 of the 3 periods. Participants were analyzed based on the treatment they received for each period regardless of their randomized treatment assignment.||P2Y12 reaction units (PRU)||Standard Deviation|Mean
816403|NCT01107925|Secondary|Change From Baseline in Vasodilator-Associated Stimulated Phosphoprotein (VASP) at Day 12 of Therapy|VASP phosphorylation levels, expressed as the platelet reactivity index (PRI), reflect the degree of thienopyridine-mediated P2Y12 receptor inhibition and were used to compare prasugrel versus clopidogrel, in low body weight (LBW) participants compared to higher body weight (HBW) participants. PRI was calculated by VASP. The PRI indicates the level of P2Y12 receptor inhibition. A lower PRI reflects stronger inhibition of P2Y12 receptor thus stronger platelet inhibition, whereas a higher PRI reflects weaker inhibition of P2Y12 receptor and weaker platelet inhibition.|Baseline, Day 12|As-treated pharmacodynamic (PD) population: all randomized participants who received at least 1 dose of study drug and provided at least 1 evaluable PD measure at 1 of the 3 periods. Participants were analyzed based on the treatment they received for each period regardless of their randomized treatment assignment.||percentage PRI||Standard Deviation|Mean
833437|NCT01258049|Secondary|PRR 12 [MITT Population]|The percentage reduction in parasite counts 12 hours after first dose|28 days after start of treatment|||percentage of baseline||Standard Deviation|Mean
816404|NCT01107925|Primary|Change From Baseline in Maximum Platelet Aggregation (MPA) to 20 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12 (Period 1)|MPA to 20 micromolar (μM) ADP was assessed by light transmission aggregometry (LTA), an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing platelet-rich plasma stimulated with a platelet activator, such as ADP, relative to platelet-poor plasma (100% light transmittance). A lower MPA reflects stronger platelet inhibition, whereas a higher MPA reflects weaker inhibition.|Baseline, Day 12|Primary intent-to-treat (ITT) pharmacodynamic (PD) population: all randomized participants who continued in the study through Day 12, and had at least 1 evaluable PD assessment at Day 12. Participants were analyzed based on the treatment group they were randomized to irrespective to the treatment they received.||percent aggregation||Inter-Quartile Range|Median
816405|NCT01108003|Secondary|Apoptosis, Cell Proliferation, and Microvessel Density||1 year|Due to the study's early termination and low accrual, data were not collected for this assessment.|||||
816406|NCT01108003|Primary|Toxicity as Assessed by National Cancer Institute (NCI) Common Toxicity Criteria Version 3.0|Number of participants with an adverse event.|14 days|All treated and eligible patients.||participants|||Number
816407|NCT01108055|Secondary|Median Overall Survival (OS) by Bellmunt Score|"Comparison between the participant's baseline Bellmunt prognostic risk factor score and survival rates.
The Bellmunt prognostic risk factor score is a tool that is often used to predict treatment outcomes before initiating a secondline treatment regimen.
The risk factors used to calculate the Bellmunt score include:
Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1
Presence of liver metastases
Presence of visceral involvement (defined as liver, lung, bone or any non-lymph node)
Lymph node-only involvement
Hemoglobin concentration < 10 g/dL
The score is calculated based on the presence of 0; 1; 2; or 3 of the above prognostic factors. This outcome reports median overall survival based on whether the participant had 0; 1; 2; or 3 prognostic factors."|4 years|Include all 32 participants, regardless of completing 2 cycles of treatment.||Months||Full Range|Median
816408|NCT01108055|Secondary|Overall Survival|Overall survival is reported as the median survival of the evaluable subjects (ie, completed 2 cycles of treatment).|4 years|Does not include participants who did not complete 2 cycles of treatment.||Months||95% Confidence Interval|Mean
816409|NCT01108055|Secondary|Overall Response Rate|"The tumor response rate was assessed per the Response Evaluation Criteria In Solid Tumors (RECIST). RECIST criteria are a set of published rules that define when cancer patients improve (respond); stay the same (stable); or worsen (progression) during treatments. RECIST criteria offer a simplified and conservative extraction of imaging data suitable for wide application in clinical trials. The criteria presume that linear measures are an adequate substitute for 2-dimensional (2D) methods and includes 4 response categories:
Complete response (CR) = Disappearance of all target lesions
Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions
Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions
Stable disease (SD) = Small changes that do not meet above criteria Tumor response rate by each response criteria."|4 years|Does not include participants who did not complete 2 cycles of treatment.||Participants|||Count of Participants
816410|NCT01108055|Secondary|Progression-free Survival (PFS)||4 years|||Months||95% Confidence Interval|Median
816411|NCT01108055|Primary|Objective Tumor Response|"The tumor response rate was assessed per the Response Evaluation Criteria In Solid Tumors (RECIST). RECIST criteria are a set of published rules that define when cancer patients improve (respond); stay the same (stable); or worsen (progression) during treatments. RECIST criteria offer a simplified and conservative extraction of imaging data suitable for wide application in clinical trials. The criteria presume that linear measures are an adequate substitute for 2-dimensional (2D) methods and includes 4 response categories:
Complete response (CR) = Disappearance of all target lesions
Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions
Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions
Stable disease (SD) = Small changes that do not meet above criteria Objective tumor response means those with response better than stable disease, ie, complete response (CR) + partial response (PR)."|Every 8 weeks|The outcome is reported as subjects with CR (complete response) + PR (partial response).||Participants|||Count of Participants
816412|NCT01108081|Secondary|Change Over 6 Months in Quality of Life|Quality of life as assessed by the Functional Outcomes of Sleep Questionnaire, change from baseline to 6 months. The potential range of scores for the Functional Outcomes of Sleep total score is 5-20 where higher scores indicate better quality of life. The total score is the sum of the 5 subscale scores (general productivity, social outcome, activity level, vigilance, intimate relationships), which are weighted means ranging from 1-4.|baseline and 6 months|Two participants did not complete the questionnaire and therefore had missing Functional Outcomes of Sleep Questionnaire scores. One participant in Diet arm and one participant in Health education arm.||units on a scale||Standard Error|Mean
816413|NCT01108081|Primary|Change Over 6 Months in Epworth Sleepiness Scale Score|Epworth Sleepiness Scale score, change in score from baseline to 6 months. Total scores range from 0-24, where higher scores indicate more sleepiness.|baseline and 6 months|Two participants did not complete the questionnaire and therefore had missing Epworth Sleepiness Scale scores. One participant in Diet arm and one participant in Health education arm.||units on a scale||Standard Error|Mean
816414|NCT01108185|Secondary|Auscultation|Participants were evaluated at Day 0 (Baseline) and 10 to 16 days later (Visit 2). The treating physician used their clinical judgment to determine the presence of abnormal breathing sounds such as wheezing or crackles using auscultation (listening for sounds within the body, usually with a stethoscope in the chest, neck or abdomen). The number of participants with each type of breath sound at Visit 2 is summarized.|Day 10 - 16|The per-protocol population was analyzed.||Participants|||Number
816415|NCT01108185|Secondary|Auscultation|Participants were evaluated at Day 0 (Baseline) and 10 to 16 days later (Visit 2). The treating physician used their clinical judgment to determine the presence of abnormal breathing sounds such as wheezing or crackles using auscultation (listening for sounds within the body, usually with a stethoscope in the chest, neck or abdomen). The number of participants with each type of breath sound at Baseline is summarized.|Day 0|The per-protocol population was analyzed.||Participants|||Number
817125|NCT01119768|Secondary|Symptom Relief Rate in 2 Treatment Regimens.|Symptom relief is defined as no more than 1 day of mild symptoms of GERD during previous 7 days after 8 weeks or 2 weeks of treatment.|8 weeks for arm 1, 2 weeks for arm 2|ITT was defined as all randomized subjects who took at least one dose of treatment.||percentage of participans|||Number
816418|NCT01108185|Secondary|Cough and Its Character|Participants were evaluated at Day 0 (Baseline) and 10 to 16 days later (Visit 2). The presence of cough and the type of cough (productive or irritating) was determined by the treating physician based on clinical judgment. The number of participants with each type of cough or no cough at Visit 2 is presented.|Day 10 - 16|The per-protocol population was analyzed.||Participants|||Number
816419|NCT01108185|Secondary|Cough and Its Character|Participants were evaluated at Day 0 (Baseline) and 10 to 16 days later (Visit 2). The presence of cough and the type of cough (productive or irritating) was determined by the treating physician based on clinical judgment. The number of participants with each type of cough or no cough at Baseline is presented.|Day 0|The per-protocol population was analyzed.||Participants|||Number
816420|NCT01108185|Secondary|Body Temperature|Body temperature was measured at Day 0 (Baseline) and 10 to 16 days later (Visit 2). Increased body temperature was defined as body temperature greater than or equal to 37 degrees Celsius/98.6 Fahrenheit. The percentage of participants with increased or normal body temperature at Visit 2 is summarized.|Day 10 - 16|The per-protocol population was analyzed.||Percentage|||Number
816421|NCT01108185|Secondary|Body Temperature|Body temperature was measured at Day 0 (Baseline) and 10 to 16 days later (Visit 2). Increased body temperature was defined as body temperature greater than or equal to 37 degrees Celsius/98.6 Fahrenheit. The percentage of participants with increased or normal body temperature at Day 0 (Baseline) is summarized.|Day 0|The per-protocol population was analyzed.||Percentage|||Number
816422|NCT01108185|Primary|The Tolerability of Klacid SR Will be Assessed by Evaluation of Adverse Events|The number of participants experiencing adverse events, serious adverse events, or adverse events leading to study discontinuation are summarized. See Reported Adverse Events for additional details.|Day 0 through Days 10 - 16|The per-protocol population was analyzed.||Participants|||Number
816423|NCT01108185|Primary|Compliance (Was the Dosage Followed - Yes, no)|Compliance was assessed by asking physicians if participants took their medication as directed and if not, the reason for noncompliance. The number of participants that completed their course of therapy or did not complete due to noncompliance is reported.|Day 10 - 16|The per-protocol population was analyzed.||Participants|||Number
816424|NCT01108237|Secondary|Sagittal Component Alignment||Pre-Op, 3 months||||||
816425|NCT01108237|Secondary|Compare AP Tibial/Femoral Component Alignment||Pre-op, 3 months||||||
816426|NCT01108237|Secondary|Compare Intraoperative Time Data (Skin-to-skin, Tourniquet, Tourniquet to Bone)||During the Procedure||||||
816427|NCT01108237|Primary|Mechanical Axis Alignment(Absolute Value Measured in Degrees)Using 51 Inch Long Leg Films|Limb alignment in TKR is important for accurate implant positioning. It is measured by looking at the mechanical axis of the limb. This axis is an imaginary line that starts at center of the femoral head and ends in the center of the talus. In a knee with normal alignment, this line (axis) passes near the joint center. Before surgery, the planned joint angle is recorded. This study measured the difference between the mechanical axis angle reached after surgery and the planned angle. Subjects with a mechanical alignment within 3 degrees of the planned angle were considered a success.|12 weeks postoperatively (when subject has reached full knee extension)|||Absolute value in degrees||Standard Deviation|Least Squares Mean
816428|NCT01108263|Secondary|Decreased Peak Plantar Pressures in Both the Static and Dynamic Phases of Gait as Compared to Pre-operative Pressure Values.||12 weeks|||participants|||Number
816429|NCT01108263|Primary|Overall Decrease in Wound Size||12 weeks|||participants|||Number
816430|NCT01108341|Secondary|Percentage of Participants With a Best Overall Response of Complete Response (CR), as Determined by the International Working Group (IWG) Criteria As Assessed by Investigators|The IWG criteria (Cheson et al 2007) for a CR is a complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy.|up to Week 32|Safety population of participants who were treated||percentage of participants||95% Confidence Interval|Number
816431|NCT01108341|Primary|Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR), as Determined by the International Working Group (IWG) Criteria As Assessed by Investigators|The IWG criteria (Cheson et al 2007) for a CR is a complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A PR is at least a 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase should be observed in the size of other nodes, liver or spleen, and no new sites of disease should be observed.|up to Week 32|Safety population of participants who were treated||percentage of participants||95% Confidence Interval|Number
816432|NCT01108406|Secondary|Measurement of Device Benefit With the Abbreviated Profile of Hearing Aid Benefit (APHAB)|The measure of the benefit of the device was assessed using the Abbreviated Profile of Hearing Aid Benefit (APHAB) , a 24-item self-assessment inventory in which the amount of difficulty in everyday situations is reported with larger numbers indicating more difficulty. Device benefit is calculated by subtracting the score obtained after using a device from the score obtained before using the device. Software is used to score the APHAB and results are compared from the different timepoints. The APHAB is well characterized and broadly used as a quantifiable measurement. The APHAB benefit scores can range from -99 (treatment worse than no treatment) to +99 (treatment better than no treatment).|3 months and 6 months|||Global Benefit Score||Standard Deviation|Mean
816433|NCT01108406|Primary|Long Term Safety|The safety outcomes were defined as no changes in medical, auditory, or dental status and no device or procedure related adverse events during the study period. Safety was evaluated by conducting a Comprehensive Medical evaluation at Enrollment and at study termination; Comprehensive Dental evaluation at Enrollment and at 3 and 6 months, with interim dental checks in between if necessary and Comprehensive Audiological evaluation at Enrollment and at 6 months.|6 months|||participants|||Number
816488|NCT01108835|Secondary|Exercise Capacity|Exercise capacity was measured by change in 6 minutes walk test distance from baseline to 12 month. 6 minute walk test is the distance that the patient can walk over 6 minutes and it can range to 0 meters to few hundred meters. This was calculated by the 12 month 6 minutes walk test distance minus that of the baseline. Positive values indicated improvement in exercise capacity.|12 month|||meters||Standard Deviation|Mean
816451|NCT01108458|Secondary|Proportion of Participants With 50% Decrease in Tumor Marker|Change in tumor marker CA19-9, assessed as a 50% decrease from baseline|3 weeks||||||
816452|NCT01108458|Secondary|No. of Events of Drug-related Toxicity|Number of incidences of serious and non-serious drug-related adverse events|3 weeks|||Drug-related adverse events|||Number
816453|NCT01108458|Secondary|Quality of Life (QoL)|Quality of life as assessed by EORTC QLQ-C30 questionnaire|3 weeks||||||
816454|NCT01108458|Secondary|Overall Survival (OS)||1 year||||||
816455|NCT01108458|Secondary|Progression-free Survival (PFS)|"Disease status evaluated by computed tomography (CT) scan and progression-free survival assessed per RECIST criteria.
Tumor response was assessed by the IRF according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeters (mm). PR was defined as greater than or equal to (≥) 30 percent (%) decrease in sum of longest diameter (LD) of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. The percentage of participants with a confirmed objective response of CR or PR was reported."|9 weeks||||||
816456|NCT01108458|Primary|Overall Response Rate by RECIST Criteria||CT imaging every 9 weeks while on protocol||||||
816457|NCT01108510|Secondary|Change From Baseline in CD4 Cell Count at Week 192||Baseline to Week 192|Participants in the ITT Analysis Set with available change data at Week 192 were analyzed.||cells/μL||Standard Deviation|Mean
816458|NCT01108510|Secondary|Change From Baseline in CD4 Cell Count at Week 144||Baseline to Week 144|Participants in the ITT Analysis Set with available change data at Week 144 were analyzed.||cells/μL||Standard Deviation|Mean
816459|NCT01108510|Secondary|Change From Baseline in CD4 Cell Count at Week 96||Baseline to Week 96|Participants in the ITT Analysis Set with available change data at Week 96 were analyzed.||cells/μL||Standard Deviation|Mean
816460|NCT01108510|Secondary|Change From Baseline in CD4 Cell Count at Week 48||Baseline to Week 48|Participants in the ITT Analysis Set with available change data at Week 48 were analyzed.||cells/μL||Standard Deviation|Mean
816461|NCT01108510|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 192|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 192 was analyzed using the snapshot algorithm.|Week 192|Week 192 Modified ITT Analysis Set: includes participants in the ITT analysis set excluding those who either (1) transferred to other Gilead-sponsored studies after completing their Week 144 visit and before the lower limit of the Week 192 analysis window, or (2) prematurely discontinued study drug prior to the Week 144 visit.||percentage of participants|||Number
816462|NCT01108510|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 144|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 144 was analyzed using the snapshot algorithm.|Week 144|ITT Analysis Set||percentage of participants|||Number
816463|NCT01108510|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm.|Week 96|ITT Analysis Set||percentage of participants|||Number
816464|NCT01108510|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the prespecified time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Intent-to-Treat (ITT) Analysis Set: participants who were randomized and received at least one dose of study drug||percentage of participants|||Number
816465|NCT01108523|Secondary|Rating Scores of Skin Erythema, Skin Pallor, Skin Maceration, Skin Denudation at Day 4, 8, and 12. Proportion of Subjects With no Denuded Skin Area at Day 4, 8, 12, and 15. Pre- and Post-Treatment Surveys||4, 8, 12, and 15 days||||||
816466|NCT01108523|Primary|Rating Scores of Skin Erythema, Skin Pallor, Skin Maceration, Skin Denudation at Day 15.||15 Days||||||
816467|NCT01108718|Primary|Mattress Preference of Fibromyalgia Patients|Study patients were asked to rate each test mattress after 2 months of use, based on their quality of sleep and severity of symptoms relating to fibromyalgia. The various stages of sleep were monitored via polysomnography(PSG) and scored to indicate the degree to which they reflect a normal sleep pattern. Change in severity of fibromyalgia symptoms were assessed by chi-squared and t-test.|6 months|Following 2 months use of each test mattress, the study patients' sleep patterns and severity of fibromyalgia symptoms were assessed. At the end of the study, study patients were asked to rate each mattress in order of preference.||percentage of study participants|||Number
816468|NCT01108731|Secondary|Change in Widespread Pain|Pain was assessed using a visual analog scale (VAS) ranging from 0 (no pain) to 10 (worst pain ever). The baseline value recorded was widespread pain at the time of assessment and the 2 months follow value recorded was widespread pain over the week prior to assessment.|2 months|Data from all 26 participants were used for analysis.||units on a scale||Standard Deviation|Mean
816469|NCT01108731|Secondary|Change in Cognitive Function Assessed by the no Cue Condition of the Attention Network Test (ANT).|The Attention Network Test (ANT) is a computerized test designed to evaluate the efficiency of the attention network. The ANT consists of a set of cued reaction time tasks to assess vigilance and efficiency to detect novel visual stimuli. The ANT also includes a set of flanker tasks during which a decision needs to be made about whether the orientation of a central stimulus is congruent or incongruent with a set of flanking arrows. Scores on the cued reaction time tasks (no cue, centre cue, double cue) reflect latency to respond measured in milliseconds (slower performance equals greater values). The score on the flanker task reflecting executive attention is derived by subtracting obtained latencies on the congruent flanker from the incongruent condition. Based on our prior work, we are hypothesizing that drug treated Ss will show improved performance on the no cue reaction time condition and on the derived executive attention variable compared to placebo treated.|Baseline and 2 months|Data from 4 were excluded due to 2 having error rates greater than 50%, indicating that they did not understand the task and 2 having simple reaction times longer than those for the complex reaction times on the ANT, suggesting their need for additional practice trials on the simple motor reaction time task.||latency to respond (msecs.)||Standard Deviation|Mean
816470|NCT01108731|Primary|Change in Ventricular Lactate Levels in the Brain|Ventricular lactate levels will be assessed before and at the end of the trial using a scanning method known as magnetic resonance spectroscopy (MRS), which is used to determine the presence and quantity of a number of chemicals in the brain.|Baseline and 2 months|One drug treated and two placebo treated could not be analyzed due to excessive head motion||international units (iu)||Standard Deviation|Mean
816471|NCT01108796|Secondary|Assessment of Metabolic Effect|Metabolic effect was rated by the investigators as 'positive', 'neutral' and 'negative'|24 weeks (Visit 1 to Visit 3)|||Participants|||Number
816472|NCT01108796|Secondary|Changes in Laboratory Parameters: Blood Glucose|Changes in the fasting blood glucose levels from baseline to final visit in patients with both laboratory values valid, by treatment and by Tool/No Tool|24 weeks (Visit 1 to Visit 3)|||mmol/l||Standard Deviation|Mean
816473|NCT01108796|Secondary|Changes in Laboratory Parameters: Triglycerides|Changes in the triglyceride levels from baseline to final visit in patients with both laboratory values valid, by treatment and by Tool/No Tool|24 weeks (Visit 1 to Visit 3)|||mmol/l||Standard Deviation|Mean
816474|NCT01108796|Secondary|Changes in Laboratory Parameters:High Density Lipoprotein (HDL)|Changes in LDL cholesterol levels from baseline to final visit in patients with both laboratory values valid, by treatment and by Tool/No Tool|24 weeks (Visit 1 to Visit 3)|||mmol/l||Standard Deviation|Mean
816475|NCT01108796|Secondary|Changes in Laboratory Parameters:Low Density Lipoprotein (LDL)|Changes in LDL cholesterol levels from baseline to final visit in patients with both laboratory values valid, by treatment and by Tool/No Tool|24 weeks (Visit 1 to Visit 3)|||mmol/l||Standard Deviation|Mean
816476|NCT01108796|Primary|Changes in Mean Blood Pressure (Diastolic) After Treatment, Compared to Baseline|Changes in blood pressure in patients with diastolic values, measured at baseline and final visit, by treatment and by Tool/No Tool|24 weeks (Visit 1 to Visit 3)|||mmHg||Standard Deviation|Mean
816477|NCT01108796|Primary|Changes in Mean Blood Pressure (Systolic) After Treatment, Compared to Baseline|Changes in blood pressure in patients with systolic values, measured at baseline and final visit, by treatment and by Tool/No Tool|24 weeks (Visit 1 to Visit 3)|||mmHg||Standard Deviation|Mean
816478|NCT01108809|Secondary|Number of Patients With Adverse Events (AE)||6 months|Treated patients||Number of participants|||Number
816479|NCT01108809|Secondary|Number of Participants Not Completing Study|Number of participants discontinuing study early for given reason|3rd visit (6 months)|Patients with data at 3rd visit||Number of participants|||Number
816480|NCT01108809|Secondary|Change in Heart Rate From Baseline to Study End||From baseline to visit 3 (6 months)|Patients with data both at baseline and on 3rd visit||beats / minute||Standard Deviation|Mean
816481|NCT01108809|Secondary|Additional Antihypertensive Treatment Pattern at Visit 3 (End of Study)||6 Months|Patients with data at 3rd visit||Percentage of participants|||Number
816482|NCT01108809|Secondary|Percentage of Patients That Achieve Target Blood Pressure Values According to the European Society of Hypertension/European Society of Cardiology (ESH/ESC)|ESH/ESC a goal of treatment to be below values 130/80 mm/Hg for diabetic patients and below 140/90 mmHg for non-diabetic patients|Visit 3 (6 months from baseline)|Patients with data at 3rd visit||Percentage of participants|||Number
816483|NCT01108809|Primary|Evolution of the European Society of Hypertension / European Society of Cardiology (ESH/ESC) Based Cardiovascular Risk Factor From Baseline to Study End|ESH is the European society of hypertension, and ESC is the European society of cardiology. Investigator judgement of evolution of CV risk based on ESH/ ESC criteria from baseline to end of study. (Positive = reduction in CV risk; Neutral = no change in CV risk; Negative = deterioration in CV risk; Missing = no data available)|From baseline to visit 3 (6 months)|Patients with data both at baseline and on 3rd visit||Percentage of participants|||Number
816484|NCT01108809|Primary|Evolution of the Cardiovascular Risk Factor Framingham From Baseline to Study End|10-year risk for hard coronary heart disease (CHD) outcomes (Myocardial Infarction and coronary death), according to Framingham Heart Study, measured in percent. Low risk (10 or less CHD risk at 10 years), intermediate risk (10-20), high risk (20 or more). Investigator judgement of evolution of Framingham risk score from baseline to end of study. (Positive = reduction in CV risk; Neutral = no change in CV risk; Negative = deterioration in CV risk; Missing = no data available)|From baseline to visit 3 (6 months)|Patients with data both at baseline and on 3rd visit||Percentage of participants|||Number
816485|NCT01108809|Primary|Evolution of the Cardiovascular Risk Factor SCORE From Baseline to Study End|A 10 year risk of fatal cardiovascular disease (CVD) in populations at high risk. Minimum 0 percent risk to Maximum 47 percent risk. Investigator judgement of evolution of SCORE from baseline to end of study. (Positive = reduction in CV risk; Neutral = no change in CV risk; Negative = deterioration in CV risk; Missing = no data available)|From baseline to visit 3 (6 months)|Patients with data both at baseline and on 3rd visit||Percentage of participants|||Number
816486|NCT01108809|Primary|Change in Diastolic Blood Pressure From Baseline to Study End||From baseline to visit 3 (6 months)|Patients with data both at baseline and on 3rd visit||mmHg||Standard Deviation|Mean
816487|NCT01108809|Primary|Change in Systolic Blood Pressure From Baseline to Study End||From baseline to visit 3 (6 months)|Patients with data both at baseline and on 3rd visit||mmHg||Standard Deviation|Mean
816493|NCT01109056|Secondary|Change From Baseline in Ocular Surface Disease Index© (OSDI©) Questionnaire Score at Week 16|Change from baseline in Ocular Surface Disease Index© (OSDI©) Questionnaire score at Week 16. The OSDI© is a 12-question survey for patients to document their dry eye disease symptoms. Each question is rated on a 5-point scale (0=none of the time and 4 = all of the time). The scores are totaled over the 12 questions and normalized/converted to a score of 0-100 (0=no disability and 100=complete disability). A negative number change from baseline represents an improvement.|Baseline, Week 16|Modified Intent to Treat: All randomized patients who received study treatment and had a baseline and at least one post-baseline assessment of pterygium hyperemia||Scores on a Scale||Standard Deviation|Mean
816494|NCT01109056|Primary|Change From Baseline in Severity Grade of Pterygium Hyperemia at Week 16|Change from Baseline in Severity Grade of Pterygium Hyperemia at Week 16. The Pterygium Hyperemia Grading Scale is a 6-point scale (0=absent, 1=trace, 2=mild, 3=moderate, 4=moderately severe, 5=severe). A negative number change from baseline is an improvement and a positive number change from baseline is a worsening.|Baseline, Week 16|"Modified Intent to Treat:
All randomized patients who received study treatment and had a baseline and at least one post-baseline assessment of pterygium hyperemia"||Scores on a Scale||Standard Deviation|Mean
816495|NCT01109056|Primary|Number of Pterygium Hyperemia Responders at Week 16|Number of pterygium hyperemia responders at Week 16 as measured by the Pterygium Hyperemia Grading Scale. The Pterygium Hyperemia Grading Scale is a 6-point scale (0=absent, 1=trace, 2=mild, 3=moderate, 4=moderately severe, 5=severe). A responder is defined as a patient demonstrating at least a 2-grade decrease from baseline in pterygium hyperemia.|Week 16|"Modified Intent to Treat:
All randomized patients who received study treatment and had a baseline and at least one post-baseline assessment of pterygium hyperemia"||Participants|||Number
816496|NCT01109108|Primary|Nasopharngeal Colonization With PCV13 S. Pneumoniae|Proportion of PCV13 serotypes among n=1851 children colonized with any S. pneumoniae|Study years 1-5|Children colonized with any S. pneumoniae (PCV and non-PCV serotypes)||Participants|||Count of Participants
816497|NCT01109147|Primary|Identification of Brain Circuits Involved in a Task of Emotional Congruence (With fMRI)|"During the fMRI session, the activation of each brain circuits is measured by a Bold signal (an arbitrary measure of contrast: numbers of voxels highlighted/activated in the region of interest).
The emotional task is composed by congruent and incongruent images. Three effects were caused by the task: congruence, attention and valence effects. Each of them affect, involve and activate the regions of interests differentially within the differents arms.
The region of interests who were mainly observed are: Anterior Cingulate Cortex (ACC), Prefrontal dorso-lateral Cortex (PFdlC) and the Amygdala (A)."|3 days after the decision of inclusion|||arbitrary units of activation||Standard Error|Mean
816498|NCT01109147|Secondary|Investigate the Level of Expression of Candidate Genes||one blood sample||||||
816499|NCT01109147|Secondary|Assessment of Personality Traits||3 days after the decision of inclusion||||||
816500|NCT01109147|Secondary|Assessment of Cognitive and Attentional Abilities||3 days after the decision of inclusion||||||
816501|NCT01109147|Secondary|Assessment of Emotional Reactivity||3 days after the decision of inclusion||||||
816502|NCT01109173|Secondary|Percentage of Patients Pain-Free at Day 14|Ocular pain as assessed by the investigator on a scale ranging from 0 (none) to 5 (severe). Pain-free was defined as a score of 0 on the investigator's assessment of ocular pain.|Day 14|All randomized patients with at least one postoperative assessment (ITT), last observation carried forward.||percentage of participants|||Number
816503|NCT01109173|Primary|Percentage of Patients Cured at Day 14|Ocular inflammation was assessed by the investigator during slit lamp examination. Aqueous cells were scored on a 5-unit scale from 0 (none) to 4 (> 30 cells), and aqueous flare (protein escaping from dilated vessels) was scored on a 4-unit scale from 0 (no visible flare when compared with the normal eye) to 3 (severe – very dense flare). To be considered cured, the patient must have had a score of 0 for both cells and flare.|Day 14|All randomized patients with at least one postoperative assessment (ITT), last observation carried forward.||percentage of participants|||Number
816504|NCT01109316|Secondary|Change From Baseline to 8 Weeks Endpoint for Each Treatment in Blood Pressure||Baseline, 8 weeks for each treatment|All randomized participants who received at least one dose of study drug and had both baseline and post-baseline blood pressure measurements for the respective treatment period.||mmHg||Standard Deviation|Mean
816505|NCT01109316|Secondary|Change From Baseline to 8 Weeks Endpoint for Each Treatment in Weight||Baseline, 8 weeks for each treatment|All randomized participants who received at least one dose of study drug and had both baseline and post-baseline weight measurements for the respective treatment period.||kilograms (kg)||Standard Deviation|Mean
816506|NCT01109316|Secondary|Hypoglycemia Episode Rate Per 30 Days|"Hypoglycemia was defined as an event which was associated with
reported signs and symptoms of hypoglycemia, and/or
a documented blood glucose (BG) concentration of ≤ 70 mg/dL (3.9 mmol/L). Rate is presented as the number of hypoglycemic episodes adjusted for 30 days."|8 weeks for each treatment|All randomized participants who received at least one dose of study drug. Participants included in hypoglycemia analyses are only those for whom data existed regarding hypoglycemia.||hypoglycemic episodes per 30 days||Standard Deviation|Mean
816507|NCT01109316|Secondary|Percentage of Participants With Hypoglycemia|"Hypoglycemia was defined as an event which was associated with
reported signs and symptoms of hypoglycemia, and/or
a documented blood glucose (BG) concentration of ≤ 70 mg/dL (3.9 mmol/L)."|8 weeks for each treatment|All randomized participants who received at least one dose of study drug. Participants included in hypoglycemia analyses are only those for whom data existed regarding hypoglycemia.||percentage of participants|||Number
816508|NCT01109316|Secondary|Pump Complication Rate Per 30 Days|Overall Pump Complications were any combination of: tubing clogged, kinked, disconnected, pulled out, blood in tubing; too much heat, too much cold, empty reservoir, low battery, occlusion alarm, no delivery alarm; at site - skin abscess, excessive redness, swelling (not nodule), bleeding, bruising; reservoir change (infusion set change reason only); and other. When either a reservoir change or an infusion set change was reported, participants were questioned whether change was early (prior to 6 days for L6D or A6D, or prior to 2 days for L2D). If 'yes', then recorded as premature change.|8 weeks for each treatment|All randomized participants who completed at least one post-randomization visit. Participants included in pump complication analyses are only those for whom data existed regarding pump complications.||pump complications per 30 days||Standard Deviation|Mean
816509|NCT01109316|Secondary|Percentage of Participants With Pump Complications|Overall Pump Complications were any combination of: tubing clogged, kinked, disconnected, pulled out, blood in tubing; too much heat, too much cold, empty reservoir, low battery, occlusion alarm, no delivery alarm; at site - skin abscess, excessive redness, swelling (not nodule), bleeding, bruising; reservoir change (infusion set change reason only); and other. When either a reservoir change or an infusion set change was reported, participants were questioned whether change was early (prior to 6 days for L6D or A6D, or prior to 2 days for L2D). If 'yes', then recorded as premature change.|8 weeks for each treatment|All randomized participants who completed at least one post-randomization visit. Participants included in pump complication analyses are only those for whom data existed regarding pump complications.||percentage of participants|||Number
816510|NCT01109316|Secondary|Hyperglycemic Episode Rate Per 30 Days|Hyperglycemia was defined as an episode with (1) a measured blood glucose concentration >250 milligrams per deciliter (mg/dL) (13.9 mmol/L) and ≥3 hours after eating, or (2) a measured blood glucose concentration >300 mg/dL (16.7 mmol/L) and <3 hours after eating. Rate is presented as the number of hyperglycemic episodes adjusted for 30 days.|8 weeks for each treatment|All randomized participants who received at least one dose of study drug. Participants included in hyperglycemia analyses are only those for whom data existed regarding hyperglycemia.||hyperglycemic episodes per 30 days||Standard Deviation|Mean
816511|NCT01109316|Secondary|Percentage of Participants With Hyperglycemia|Hyperglycemia was defined as an event with (1) a measured blood glucose concentration >250 milligrams per deciliter (mg/dL) (13.9 mmol/L) and ≥3 hours after eating, or (2) a measured blood glucose concentration >300 mg/dL (16.7 mmol/L) and <3 hours after eating.|8 weeks for each treatment|All randomized participants who received at least one dose of study drug. Participants included in hyperglycemia analyses are only those for whom data existed regarding hyperglycemia.||percentage of participants|||Number
816512|NCT01109316|Secondary|Number of Participants Who Achieve or Maintain an HbA1c Less Than or Equal to 6.5% and Less Than 7%||8 weeks for each treatment|All randomized participants who completed a post-randomization visit and had an HbA1c measurement for the respective treatment period.||participants|||Number
816513|NCT01109316|Secondary|Change From Baseline to 8 Weeks Endpoint for Each Treatment in Hemoglobin A1c (HbA1c) Values||Baseline, 8 weeks for each treatment|All randomized participants who completed at least one post-randomization visit, and had a baseline and a post-randomization HbA1c measurement for the respective treatment period. Last Observation Carried Forward (LOCF) method was utilized in this analysis.||percentage of glycosylated hemoglobin||Standard Deviation|Mean
816514|NCT01109316|Secondary|Mean Daily Insulin Dose (Total, Basal, and Bolus)||8 weeks for each treatment|All randomized participants who completed at least one post-randomization visit. Participants included in insulin analyses are only those for whom data existed regarding insulin dose.||Units (U) of insulin||Standard Deviation|Mean
816515|NCT01109316|Secondary|Mean SMBG|Mean SMBG for combined periods; all reported SMBG values on days 1-6 for Insulin Lispro 6 Day and Insulin Aspart 6 Day, and days 1-2 for Insulin Lispro 2 Day.|8 weeks for each treatment|All randomized participants who completed at least one post-randomization visit and one SMBG measurement on Day 2 for insulin lispro 2 day or Day 6 for the respective treatment arm: insulin lispro 6 day and insulin aspart 6 day.||mmol/L||Standard Deviation|Mean
816516|NCT01109316|Primary|Mean of Last Five 7-point Self Monitored Blood Glucose (SMBG) Taken on Day 6 for Insulin Lispro 6D and Day 2 for Insulin Lispro 2D and Day 6 for Insulin Aspart 6D Pump Reservoir In-use||8 weeks of each treatment|All randomized participants who completed at least one post-randomization visit. Those included in the Primary analysis had to have at least one reservoir in-use cycle with an SMBG measurement on Day 6 during the pre-specified collection period.||millimoles per liter (mmol/L)||Standard Deviation|Mean
816517|NCT01109381|Secondary|Assessment of Adverse Events (AE)|Adverse event data will be collected in response to neutral questioning.|AE commencing within 30 days of initiation of treatment, followed until resolution|All participants entering the study are included in the safety analysis||participants|||Number
816518|NCT01109381|Primary|Absence of Significant Gastric Abnormality Post-treatment (Initial Phase)|Gastroscopy pre- and post-treatment will be performed in the Initial Phase (20 participants), with the goal of excluding significant gastric abnormality at baseline and after treatment (e.g. gastric ulceration arising following the treatment).|up to 14 days of treatment|All 21 Initial Phase participants had a pretreatment gastroscopy, and 20 had post-treatment gastroscopy (one participant prematurely discontinued the study prior to receiving GT08, and the participant later lost to follow up had a post-treatment gastroscopy before being lost to follow up)||participants|||Number
816519|NCT01109381|Primary|Number of Participants With Eradication of H.Pylori Infection|Eradication as measured by negative Urea Breath Test 4-6 weeks following completion of treatment|4-6 weeks following treatment|Two participants did not complete the study, one discontinuing after experiencing adverse events while receiving only the initial study omeprazole, and the other participant left Singapore before they had their final urea breath test. All other study participants were analysed for efficacy.||participants|||Number
816520|NCT01109524|Primary|Number of Participants With Grades 3 and 4 Drug-Related Treatment-emergent AEs of Special Interest - Treated Population|Drug-related AEs (investigator assessment): those with relationship to study drug(s)reported as related and those of unknown relationship. Special interest AEs: acneform rash, infusion reaction, cardiac adverse event, febrile neutropenia, infection (all terms except sepsis), sepsis, interstitial lung disease, renal failure, and thromboembolic events. Except for interstitial lung disease, these were composite terms combining several MedDRA terms (MedDRA version 14.0). Except for Gr 3 and 4 infusion reactions, AE severity per NCI-CTC, version 3.0: Gr 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. Gr 3 - 4 infusion reactions: Gr 3=symptomatic bronchospasm, requiring parenteral medication(s), with or without urticaria; allergy-related edema/angioedema; Gr 4=life-threatening event with same Gr 3 symptomatology, complicated by symptomatic hypotension/oxygen saturation 70% or less. Day 1=start of study drug; to 30 days after last dose of any treatment.|Day 1 up to 30 days after last dose|Treated population: All participants who received at least one dose of any study drug.||participants|||Number
816529|NCT01109602|Primary|Balance - Measured With the Berg Balance Scale|Balance was assessed with the Berg Balance Scale (BBS), a 14-item physical performance measure of static and dynamic balance found to be reliable and valid after stroke. Scoring ranges from 0-56, with higher scores indicating better balance. A score of <46 identifies an individual at risk for falls after stroke.|2 months|||units on a scale||Standard Deviation|Mean
816521|NCT01109524|Primary|Number of Participants With Drug-Related Treatment-emergent AEs, Drug-Related SAEs, and Drug-Related AEs Leading to Discontinuation of at Least One Study Drug, - Treated Population|Drug-related AEs and drug-related SAEs (by investigator assessment) were those with a relationship to study drug(s) reported to Sponsor as related and those of unknown relationship. AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE was defined as a medical event that results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. MedDRA version 14.0. Severity of AEs were graded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 3.0: Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. Day 1 (start of study drug) to 30 days after last dose of any study drug, including monotherapy.|Day 1 up to 30 days after last dose|Treated population: All participants who received at least one dose of any study drug.||participants|||Number
816522|NCT01109524|Primary|Number of Participants With Renal Function Serum Chemistry Laboratory Abnormalities - Treated Population|ULN=Upper limit of normal among all laboratory ranges; LLN=Lower limit of normal. CTC grade criteria: Sodium high (H) Grade (Gr) 1:>ULN - 150 millimoles per liter (mmol/L); Gr 2: >150 – 155 mmol/L; Gr 3: >155 – 160mmol/L; Gr 4: >160 mmol/L. Sodium low(L) Gr 1:<LLN – 130mmol/L; Gr 3: <130 – 120 mmol/L; Gr 4: <120 mmol/L. Potassium (H) Gr 1: >ULN – 5.5 mmol/L; Gr 2: >5.5 – 6.0 mmol/L; Gr 3: > 6.0 – 7.0 mmol/L; Gr 4: >7.0 mmol/L. Potassium (L) Gr 1: <LLN – 3.0 mmol/L; Gr 2: <LLN – 3.0 mmol/L; Gr 3: < 3.0 – 2.5 mmol/L; Gr 4: <2.5 mmol/L. Serum creatinine (H) Gr 1: >1 – 1.5*baseline (BL)to >ULN – 1.5*ULN; Gr 2: >1.5 – 3.0*BL to > 1.5 – 3.0*ULN; Gr 3: >3.0*BL to > 3.0 – 6.0*ULN; Gr 4: >6.0*ULN. Day 1 (start of study drug) to 30 days after last dose of any study drug, including monotherapy.|Day 1 up to 30 days after last dose|Treated population: All participants who received at least one dose of any study drug.||participants|||Number
816523|NCT01109524|Primary|Number of Participants With Hematology Laboratory Abnormalities - Treated Population|Hematology laboratories included hemoglobin, platelets, white blood cell (WBC) count, and absolute neutrophil count (ANC) and values were per CTC grading, 0, 1, 2, 3, 4. On-study laboratory tests were those performed after the start of study drug (from Day 2 of cycle 1) and up to 30 days after the last dose of study drug. WBC normal range: 4.1-12.3 x 10^3 /microliter (µL); platelets normal range: 140-450 x 10^9 /Liter (L); hemoglobin normal range 14-18 grams per deciliter (g/dL); ANC normal range: 2.03-8.36 x 10^9/μL.|Day 2 up to 30 days after last dose|Treated population: all participants who received at least one dose of any study drug. Participants with at least one on-study laboratory measurement available were analyzed.||participants|||Number
816524|NCT01109524|Primary|Number of Participants With Liver Function Serum Chemistry Laboratory Abnormalities - Treated Population|ULN=Upper limit of normal among all laboratory ranges. ALT=alanine transaminase; AST=aspartate aminotransferase; ALP=alkaline phosphatase. CTC grade criteria: ALT Grade 1:>ULN 2.5*ULN; Grade 2: >2.5 - 5.0*ULN; Grade 3: >5.0 - 20.0*ULN; Grade 4: >20.0*ULN. AST Grade 1: >ULN - 2.5*ULN; Grade 2: >2.5 - 5.0*ULN; Grade 3: >5.0 - 20.0*ULN; Grade 4: >20.0*ULN. Total bilirubin Grade 1: >ULN - 1.5*ULN; Grade 2: >1.5 - 3.0*ULN; Grade 3: >3.0 - 10.0*ULN; Grade 4: >10.0*ULN. Albumin (low) Grade 1:<LLN - 3 grams per deciliter (g/dL)to <LLN - 3 g/dL; Grade 2: <3 - 2 g/dL to < 3.0 - 2.0 g/dL; Grade 3: < 2 g/dL to <2 g/L. Day 1 (start of study drug) to 30 days after last dose of any treatment therapy, including cetuximab monotherapy.|Day 1 up to 30 days after last dose|Number (N) of participants with laboratory data available and who could be analyzed for total bilirubin was 49. All other liver function laboratories N=57. Treated population: all participants who received at least one dose of any study drug.||participants|||Number
816525|NCT01109524|Primary|Number of Participants With Grades 3 and 4 Treatment-emergent Adverse Events (AEs) of Special Interest - Treated Population|Special interest AEs: acneform rash, infusion reaction, cardiac adverse event, febrile neutropenia, infection (includes all terms except sepsis), sepsis, interstitial lung disease, renal failure, and thromboembolic events. Except for interstitial lung disease, these were composite terms combining several preferred/other level MedDRA terms (MedDRA version 14.0). Except for Grade (GR)3 and 4 infusion reactions, AE severity were graded per the NCI-CTC, version 3.0: Gr 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. Severity of Gr 3 - 4 infusion reactions were: Gr 3=symptomatic bronchospasm, requiring parenteral medication(s), with or without urticaria; allergy-related edema/angioedema; Gr 4=a life-threatening event characterized by the same symptomatology as a Gr 3, complicated by symptomatic hypotension or oxygen saturation 70% or less. Day 1 (start of study drug) to 30 days after last dose of any treatment therapy, including cetuximab monotherapy.|Day 1 to 30 days after last dose|Treated population: all participants who received at least one dose of any study drug.||participants|||Number
816526|NCT01109524|Primary|Number of Participants With Any Treatment-emergent Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation of at Least One Study Drug, - Treated Population|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=medical event that results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. MedDRA version 14.0. Severity of AEs were graded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 3.0: Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. Day 1 (start of study drug) to 30 days after last dose of any treatment therapy, including cetuximab monotherapy.|Day 1 up to 30 days after last dose|Treated population: all participants who received at least one dose of any study drug.||participants|||Number
816527|NCT01109576|Primary|Change in Profile of Mood States Total Score.|The change in Profile of Mood States total score is defined as the 8 week follow-up total score minus the baseline POMS total score. The scale measures change in mood states before and after treatment. The change score can range from -232 to 232, with negative values indicating greater reduction in emotional distress.|Change in Profile of Mood States Score from Baseline to 8 Weeks|||units on a scale||Standard Deviation|Mean
816528|NCT01109602|Secondary|Quality of Life - Measured With the Stroke Specific Quality of Life|Quality of Life was measured using the validated 49 items of the Stroke Specific QoL scale (SSQoL). The SSQoL includes assessment of 12 domains: self-care; vision; language; mobility; work; upper extremity; thinking; personality; mood; family; social; and energy. Prior work indicates good psychometric properties. Higher scores indicate increased QoL. Range of scores is 13 to 65 for the total score.|2 months|||units on a scale||Standard Deviation|Mean
816530|NCT01109602|Secondary|Balance Self-efficacy - Measured With the Activities Balance Confidence Scale|The 16 item Activities-specific Balance Confidence Scale (ABC) was used to measure balance self-efficacy. The ABC is a self-report of a participant's self-efficacy in maintaining static and dynamic balance control during functional tasks. The validity and reliability of the ABC have been previously demonstrated in individuals with stroke. Scoring is 'no confidence' (0%) to 'completely confident' (100%).|2 months|||units on a scale||Standard Deviation|Mean
816531|NCT01109849|Post-Hoc|Change in BMI z Score During Weight Recovery Period (Second Randomization) Based on Actual Usage|"difference in height z score from entry into weight recovery phase to exit from that phase (exact duration varied by participant). Randomization could not occur before month 6 (so max of 24 month duration) but could start as late as month 29 (equaling a 1 month duration) based on the pattern of zBMI change. In this post hoc analysis we grouped participants by what they did (caloric supplementation, drug holiday or monitoring) not what they were randomly assigned to. The most common change was from drug holiday to monitoring for participants who were not using medication on weekends before assignment to drug holiday (family stopped weekend med by own accord prior to 2nd randomization) so assignment to drug holiday did not alter actual frequency of use as was designed to.Therefore they were reclassified as monitoring as frequency of med use did not change.
Z score used to account for differences in age and gender between groups. Higher values reflect greater incremental BMI increase."|between 1 month and 24 months|all participants prescribed an ER stimulant and also assigned to one of the weight recovery treatments. Arms from first randomization are not included as not all of those participants progressed to the second randomization which was done adaptively based on change in zBMI. Those arms are reported on for outcome 15.||Z score||Standard Deviation|Mean
816532|NCT01109849|Post-Hoc|Change in Weight z Score During Weight Recovery Phase (Second Randomization) Based on Actual Usage|"difference in height z score from entry into weight recovery phase to exit from that phase (exact duration varied by participant). Randomization could not occur before month 6 (so max of 24 month duration) but could start as late as month 29 (equaling a 1 month duration) based on the pattern of zBMI change. In this post hoc analysis we grouped participants by what they did (caloric supplementation, drug holiday or monitoring) not what they were randomly assigned to. The most common change was from drug holiday to monitoring for participants who were not using medication on weekends before assignment to drug holiday (family stopped weekend med by own accord prior to 2nd randomization) so assignment to drug holiday did not alter actual frequency of use as was designed to.Therefore they were reclassified as monitoring as frequency of med use did not change.
Z score used to account for differences in age and gender between groups. Higher values reflect greater incremental weight gain."|between 1 month and 24 months|participants using an ER stimualnt and also randomized to one of the weight recovery treatments. Arms from first randomization are not included as not all of those participants progressed to the second randomization which was done adaptively based on change in zBMI. Those arms are reported on for outcome 14.||zscore||Standard Deviation|Mean
816533|NCT01109849|Post-Hoc|Difference in Height z Score During Weight Recovery Phase (Second Randomization) by Actual Usage|"difference in height z score from entry into weight recovery phase to exit from that phase (exact duration varied by participant). Randomization could not occur before month 6 (so max of 24 month duration) but could start as late as month 29 (equaling a 1 month duration) based on the pattern of zBMI change. In this post hoc analysis we grouped participants by what they did (caloric supplementation, drug holiday or monitoring) not what they were randomly assigned to. The most common change was from drug holiday to monitoring for participants who were not using medication on weekends before assignment to drug holiday (family stopped weekend med by own accord prior to 2nd randomization) so assignment to drug holiday did not alter actual frequency of use as was designed to.Therefore they were reclassified as monitoring as frequency of med use did not change.
Z score used to account for differences in age and gender between groups. Larger values reflect greater height change."|between 1 month and 24 months|all participants using an ER stimulant and were also assigned to a weight recovery arm. Arms from first randomization are not included as not all of those participants progressed to the second randomization which was done adaptively based on change in zBMI. Those arms are reported on for outcome 13.||Z score||Standard Deviation|Mean
816534|NCT01109849|Post-Hoc|Change in BMI z Score by Actual Medication Usage|measures change in BMI z score from baseline to last assessment with participants grouped based on actual medication usage versus randomly assigned group since participants were allowed to cross treatment arms after 6 months and not all participants assigned to medication used it consistently. The rarely med group (n=44) used med <12.5% of the study duration (with most using not at all). The consistent med group (N=38 used med for at least 87.5% of their time in the study with most using the entire time). The inconsistent med group (N=111, 27.5% used medication 45% of the time in the study. The other 37 participants did not have one year of growth data so were excluded from this analysis. Z scores used to account for differences in age and gender between groups. Higher values represent a larger BMI|baseline to month 30 or last assessment point|Includes all participants with at least one year of growth data as goal was to assess impact of extended treatment on growth. These same outcomes are reported elsewhere for the first randomization arms of Behavior Therapy and Med as well as the second randomization arms of cal supplement, drug holiday and monitoring (see outcomes 3 and 12).||Z score||Standard Deviation|Mean
816535|NCT01109849|Post-Hoc|Change in Weight z Score by Actual Medication Usage|measures change in weight z score from baseline to last assessment with participants grouped based on actual medication usage versus randomly assigned group since participants were allowed to cross treatment arms after 6 months and not all participants assigned to medication used it consistently. The rarely med group (n=44) used med <12.5% of the study duration (with most using not at all). The consistent med group (N=38 used med for at least 87.5% of their time in the study with most using the entire time). The inconsistent med group (N=111, 27.5% used medication 45% of the time in the study. The other 37 participants did not have one year of growth data so were excluded from this analysis. Z scores used to account for differences in age and gender between groups. Higher values represent a greater incremental weight gain.|baseline to month 30 or last assessment point|Includes all participants with at least one year of growth data as goal was to assess impact of extended treatment on growth. These same outcomes are reported elsewhere for the first randomization arms of Behavior Therapy and Med as well as the second randomization arms of cal supplement, drug holiday and monitoring (see outcomes 2 and 11).||Z score||Standard Deviation|Mean
816536|NCT01109849|Post-Hoc|Change in Height z Score by Actual Medication Usage|measures change in height z score from baseline to last assessment with participants grouped based on actual medication usage versus randomly assigned group since participants were allowed to cross treatment arms after 6 months and not all participants assigned to medication used it consistently. The rarely med group (n=44) used med <12.5% of the study duration (with most using not at all). The consistent med group (N=38 used) med for at least 87.5% of their time in the study with most using the entire time. The inconsistent med group (N=111), used medication between 12.5 to 87.5 of the time (mean time on med was 45% of the time in the study) The other 37 participants did not have one year of growth data so were excluded from this analysis. Z scores used to account for differences in age and gender between groups. More negative values reflecting a smaller incremental height gain.|baseline to month 30 or last assessment point|Includes all participants with at least one year of growth data as goal was to assess impact of extended treatment on growth. These same outcomes are reported elsewhere for the first randomization arms of Behavior Therapy and Med as well as the second randomization arms of cal supplement, drug holiday and monitoring (see outcomes 1 and 10).||Z score||Standard Deviation|Mean
816537|NCT01109849|Secondary|Change in Zscore for BMI During Weight Recovery Phase (Second Randomization)|"difference in BMI z score from entry into weight recovery phase to exit from weight recovery phase (exact duration varied by participant). Randomization could not occur before month 6 (equaling a 24 month duration) but could start as late as month 29 (equaling a 1 month duration) of treatment based on the pattern of zBMI change by the individual participant.
Z scores used to account for differences in age and gender. Larger values reflecting a greater incremental BMI gain."|between 1 month and 24 months|all participants prescribed an ER stimulant who were also went through the second randomization to one of three weight recovery interventions. First randomization arms not included as not all of those participants had a second randomization as it was adaptively based on change in zBMI.||Z score||Standard Deviation|Mean
816538|NCT01109849|Secondary|Change in Weight z Score During Weight Recovery Phase (Second Randomization)|"difference in weight z score from entry into weight recovery phase to exit from weight recovery phase (exact duration varied by participant). Randomization could not occur before month 6 (equaling a 24 month duration) but could start as late as month 29 (equaling a 1 month duration) of treatment based on the pattern of zBMI change by the individual participant.
Z scores used to account for differences in age and gender. Larger values reflect a greater incremental weight gain."|1 to 24 months duration|all participants prescribed an ER stimulant who were also went through the second randomization to one of three weight recovery interventions.First randomization arms not included as not all of those participants had a second randomization as it was adaptively based on change in zBMI.||Z score||Standard Deviation|Mean
816539|NCT01109849|Secondary|Change in Height z Score During Weight Recovery Phase (Second Randomization)|"difference in height z score from entry into weight recovery phase to exit from weight recovery phase (exact duration varied by participant). Randomization could not occur before month 6 (equaling a 24 month duration) but could start as late as month 29 (equaling a 1 month duration) of treatment based on the pattern of zBMI change by the individual participant.
Z scores used to account for differences in age and gender. More negative values reflecting less incremental height gain."|between 1 month and 24 months|all participants prescribed an ER stimulant who were also went through the second randomization to one of three weight recovery interventions. One monitoring participant never prescribed med was excluded.First randomization arms not included as not all of those participants had a second randomization as it was adaptively based on change in zBMI.||Z score||Standard Deviation|Mean
816540|NCT01109849|Secondary|Number of Behavior Therapy Sessions|Raw number of behavior therapy sessions attended; participants could cross over to other treatment arm if moderately impaired after 6 months in initial randomly assigned arm|months 0 through 30|those with at least one follow up assessment. The second randomization arms are not included as all participants in those arms are derived from these two groups and this assessment period includes the entire duration of the second randomization. Also, the second randomization addressees weight gain, not ADHD treatment.||sessions attended||Standard Deviation|Mean
816541|NCT01109849|Secondary|Medication Adherence|% of study days that study ADHD medication was taken when prescribed to be taken; behavior group could be prescribed medication if moderately impaired still after month 6. Once prescribed, all medication was prescribed to be taken 7 days a week except for in the drug holiday weight recovery arm.|denominator is number of days in study for which study med was prescribed|any participants with at least one dose of med prescribed. The second randomization arms are not included as all participants in those arms are derived from these two groups and this assessment period includes the entire duration of the second randomization. Also, the second randomization addressees weight gain, not ADHD treatment.||% of days dose taken as prescribed|||Number
816542|NCT01109849|Secondary|ADHD Symptoms- Teacher Rated|sum of items on 10 item IOWA Conners with range from 0-30 and larger values indicating greater symptoms. Collected at endpoint or last assessment point.|month 30 or last assessment point|those assigned to either Behavior therapy or ER stimulant with at least one post baseline assessment of ADHD symptoms. Second randomization arms (drug holiday, cal supplement, monitoring) not included as only relevant outcomes are ht, wt and BMI. All subjects in these arms are either in behavior therapy or er stimulant arm from 1st randomization.||units on a scale||Standard Deviation|Mean
816543|NCT01109849|Secondary|Change Score for Zheight Months 0 to 6|"in addition to the primary outcome of height at month 30, change in z-height from baseline to study month 6 post is also reported. Subjects who were still moderately impaired after 6 months in their initial treatment arm were allowed to cross over and receive the treatments in the other arm so prior to month 6 no participants randomized to behavior arm were prescribed study medication.
This outcome includes all participants with 2+ growth assessments from the behavior therapy and ER stimulant arms. Doesn't include adaptive randomization arms (drug holiday, cal supplement, monitoring) as they didn't exist until 2nd randomization which did not occur until after this assessment period was over.
Height converted to z score to account for differences in age and gender. More negative values reflecting smaller incremental height gain.
If participant dropped out prior to month 6, then the last assessment point was used."|baseline to month 6|participants with at height measurement at month 6||Z score||Standard Deviation|Mean
816544|NCT01109849|Secondary|ADHD Symptoms- Parent Rated|sum of score on 10 item IOWA Conners with range from 0 to 30 and higher values indicating more symptoms. Collected at end point or last assessment point.|at month 30 or last collected assessment point|those assigned to either Behavior therapy or ER stimulant with at least one post baseline assessment of ADHD symptoms. Second randomization arms (drug holiday, cal supplement, monitoring) not included as only relevant outcomes are ht, wt and BMI. All subjects in these arms are either in behavior therapy or er stimulant arm from 1st randomization.||units on a scale||Standard Deviation|Mean
816545|NCT01109849|Secondary|Treatment Adherence for Caloric Supplement|percent of days caloric supplement were taken versus prescribed in caloric supplement arm|from entry to exit of caloric supplement arm|those assigned to caloric supplement group||percentage of days||Standard Deviation|Mean
816546|NCT01109849|Secondary|Change in zBody Mass Index (BMI)|BMI will be calculated at endpoint (month 30). Difference between baseline and endpoint (month 30 or last assessment point if did not finish study). Measured as a zscore with more negative units reflecting less BMI gain. Z units used to account for differences between groups in gender and age with both impact BMI at a fixed time.|baseline to month 30 or last assessment point|includes all with 2+ growth assessments from the behavior therapy and ER stimulant arms. Doesn't include adaptive randomization arms (drug holiday, caloric supplement, monitoring) as they did not exist until 2nd randomization. See outcome #12 for change in zBMI from beginning to end of second randomization.||Z score||Standard Deviation|Mean
816547|NCT01109849|Secondary|Change Score for z Weight|difference between baseline and endpoint (month 30 or last assessment point if did not finish study). Measured as a zscore with more negative units reflecting lesser weight gain. Z units used to account for differences between groups in gender and age with both impact weight at a fixed time.|baseline to month 30 or to last assessment point|includes all with 2+ growth assessments from the behavior therapy and ER stimulant arms. Doesn't include adaptive randomization arms (drug holiday, caloric supplement, monitoring) as they did not exist until 2nd randomization. See outcome #11 for change in zwt from beginning to end of second randomization.||Z score||Standard Deviation|Mean
816548|NCT01109849|Primary|Change Score for Z-height Baseline to Endpoint|"The primary endpoint will be change in z-height at month 30 which is study endpoint.
Measured as a zscore with more negative units reflecting smaller incremental height gain. Z units used to account for differences between groups in gender and age with both impact height at a fixed time."|month 30 or last assessment point|includes all with 2+ growth assessments from the behavior therapy and ER stimulant arms. Doesn't include adaptive randomization arms (drug holiday, cal supplement, monitoring) as they didn't exist until 2nd randomization. See outcome #10 for change in zht from beginning to end of second randomization.||Z score||Standard Deviation|Mean
816549|NCT01109979|Primary|Brachial Artery Reactivity % Flow Mediated Dilation (BAR %FMD)|This crossover study examined the effects of E+MPA versus E+DRSP on brachial artery reactivity (BAR) assessed after six weeks of treatment. BAR is a noninvasive measure of endothelium-dependent flow-mediated vasodilation (FMD) of the brachial artery. With this technique, inflation of an arm blood pressure cuff to suprasystolic blood pressure causes relative ischemia downstream to the cuff. Upon deflation, a brief state of increased blood flow occurs (reactive hyperemia), and the resulting increase in shear stress causes nitric oxide release and resulting vasodilation of the brachial artery (flow-mediated vasodilation). The flow-mediated changes in brachial artery diameter can be imaged by ultrasound and measured as an index of peripheral vasomotor function. BAR correlates with invasive assessments of coronary endothelial function as well as multiple cardiovascular risk factors.|%FMD after 6 weeks of treatment|The number of participants for analysis includes only the participants that completed a baseline assessment and at least one of the treatment arms.||% FMD after 6 weeks of treatment||Standard Deviation|Mean
816550|NCT01110005|Secondary|Time to Delivery|Compare time to delivery between the D5LR and LR treatment groups|From onset of labor to delivery|||hours||Inter-Quartile Range|Median
816551|NCT01110005|Secondary|Oxytocin Augmentation|Compare augmentation rates between the D5LR and LR treatment groups|From onset of labor to delivery|||Participants|||Count of Participants
816552|NCT01110005|Primary|C-Section|Compare c-section rates between the D5LR and LR treatment groups|From onset of labor to delivery|||Participants|||Count of Participants
816553|NCT01103934|Secondary|Change From Baseline in Daytime Nasal Symptom Score (DNSS) Over 2 Week Randomized Treatment Period|Patients recorded the severity of sneezing, runny nose, stuffy nose, and other symptoms (e.g. itchy nose/throat) twice a day on a scale from 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe). The DNSS was calculated as the sum of all scores for morning with a range of 0 to 12. The change from baseline for each day of treatment was then calculated for each subject. So that each subject only had one observation, the average of these changes was calculated for each subject, and this summary measure was used in the analysis comparing the two treatment groups. We report the median and full range of these average changes for each group. A negative value indicates an improvement in daytime symptoms.|Baseline and 2 weeks|||units on a scale||Full Range|Median
816554|NCT01103934|Primary|Change From Baseline in Total Nasal Symptom Score (TNSS) Over 2 Week Randomized Treatment Period|Patients recorded the severity of sneezing, runny nose, stuffy nose, and other symptoms (e.g. itchy nose/throat) twice a day on a scale from 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe). The TNSS was calculated as the sum of all scores for morning and evening recordings with a range of 0 to 24. The change from baseline for each day of treatment was then calculated for each subject. So that each subject only had one observation, the average of these changes was calculated for each subject, and this summary measure was used in the analysis comparing the two treatment groups. We report the median and full range of these average changes for each group. A negative value indicates an improvement in symptoms.|Baseline and 2 weeks|||units on a scale||Full Range|Median
816555|NCT01103960|Secondary|Clinically Relevant Abnormalities for Physical Examination, Pulse Rate, Laboratory Parameters and ECG.|Clinically relevant abnormalities for Physical examination, pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.|From drug administration until end of treatment plus one day|Treated set included patients who were randomised and took at least one dose of the trial medication in the double-blind treatment period.||participants|||Number
817910|NCT01121666|Secondary|E2 Concentration at Day 8 and at Day of hCG Administration|The serum concentration of oestradiol was assessed at day 8 and the day of hCG administration.|Day 8 of stimulation and at the day of hCG administration (after max. 16 days of r-FSH treatment)|All participants were analyzed.||pmol/ L||Standard Deviation|Mean
816556|NCT01103960|Secondary|Number of Patients in Blood Pressure Categories at 4 Weeks|BP optimal: SBP <120 mmHg and DBP <80 mmHg, BP normal: SBP <130 mmHg and DBP <85 mmHg but not optimal, BP high-normal: SBP <140 mmHg and DBP <90 mmHg but not normal. Grade 1 hypertension: SBP <160 mmHg and DBP <100 mmHg but not high-normal, Grade 2 hypertension: SBP <180 mmHg and DBP <110 mmHg but not grade 1, Grade 3 hypertension: SBP >=180 mmHg or DBP >=110 mmHg.|4 weeks|FAS with LOCF||Number of participants|||Number
816557|NCT01103960|Secondary|DBP and SBP Control and Response After 4 Weeks of Treatment|DBP control is defined as DBP <90 mmHg or <80 mmHg in patients with diabetes or renal impairment. SBP control is defined as SBP <140 mmHg or <130 mmHg in patients with diabetes or renal impairment. DBP response is defined as DBP <90 mmHg or <80 mmHg in patients with diabetes or renal impairment or a reduction from baseline >=10mmHg. SBP response is defined as SBP<140 mmHg or <130 mmHg in patients with diabetes or renal impairment or a reduction from baseline >=15mmHg.|Baseline and 4 weeks|FAS with LOCF||Number of participants|||Number
816558|NCT01103960|Secondary|Change From Baseline in SBP After 4 Weeks of Treatment|Seated trough SBP after 4 weeks.|Baseline and 4 weeks|FAS with LOCF||mmHg||Standard Deviation|Mean
816559|NCT01103960|Secondary|Change From Baseline in DBP After 4 Weeks of Treatment|Seated trough DBP after 4 weeks.|Baseline and 4 weeks|FAS with LOCF||mmHg||Standard Deviation|Mean
816560|NCT01103960|Secondary|Number of Patients in Blood Pressure Categories Over Time|BP optimal: SBP <120 mmHg and DBP <80 mmHg, BP normal: SBP <130 mmHg and DBP <85 mmHg but not optimal, BP high-normal: SBP <140 mmHg and DBP <90 mmHg but not normal. Grade 1 hypertension: SBP <160 mmHg and DBP <100 mmHg but not high-normal, Grade 2 hypertension: SBP <180 mmHg and DBP <110 mmHg but not grade 1, Grade 3 hypertension: SBP >=180 mmHg or DBP >=110 mmHg.|8 weeks|FAS with LOCF||Number of participants|||Number
816561|NCT01103960|Secondary|DBP and SBP Control and Response After 8 Weeks of Treatment|DBP control is defined as DBP <90 mmHg or <80 mmHg in patients with diabetes or renal impairment. SBP control is defined as SBP <140 mmHg or <130 mmHg in patients with diabetes or renal impairment. DBP response is defined as DBP <90 mmHg or <80 mmHg in patients with diabetes or renal impairment or a reduction from baseline >=10mmHg. SBP response is defined as SBP<140 mmHg or <130 mmHg in patients with diabetes or renal impairment or a reduction from baseline >=15mmHg.|Baseline and 8 weeks|FAS with LOCF||Number of participants|||Number
816562|NCT01103960|Secondary|Change From Baseline in SBP After 8 Weeks of Treatment|Seated trough SBP after 8 weeks or LOCF. Analysis will be adjusted for treatment, country, and baseline measurement of endpoint.|Baseline and 8 weeks|FAS with LOCF||mmHg||Standard Error|Least Squares Mean
816563|NCT01103960|Primary|Change From Baseline in DBP After 8 Weeks of Treatment in Chinese Patients|Seated trough DBP after 8 weeks or LOCF in Chinese patients. Analysis will be adjusted for treatment and baseline measurement of endpoint.|Baseline and 8 weeks|FAS with LOCF and further restricted to the Chinese subgroup||mmHg||Standard Error|Least Squares Mean
816564|NCT01103960|Primary|Change From Baseline in DBP After 8 Weeks of Treatment|Seated trough DBP after 8 weeks or last observation carried forward (LOCF). Analysis will be adjusted for treatment, country, and baseline measurement of endpoint.|Baseline and 8 weeks|Full analysis set (FAS) defined as patients randomised, treated, with a baseline endpoint measurement and at least one post-dose endpoint measurement during the double blind (DB) phase.||mmHg||Standard Error|Least Squares Mean
816565|NCT01103973|Primary|Clinical Pregnancy Rates|Presence of normal fetal heart rate and fetal size at 7 weeks gestation.|1 year|||percentage of participants|||Number
816566|NCT01104103|Secondary|First Stick Success|This outcome will report the number of IV attempts as defined by the tip of the needle piercing the skin. The results for each IV attempt will be an ordinal number between one and three. We will compare the number and percentage of patients in each group (1, 2, or 3 sticks) between the two therapies.|Five minutes (average)|||participants|||Number
816567|NCT01104103|Primary|Success|This outcome will measure self-reported success at starting the peripheral intravenous lines in the upper extremity of adults. Success is defined as an IV line through which blood may be aspirated and flushes freely without evidence of fluid extravasation. To be successful, the IV must be placed within a maximum of three attempts. We will report the number and percentage of patients with successful for both therapies.|five minutes (average)|||participants|||Number
816568|NCT01104116|Secondary|Change in Lesion Characteristics to Assess Benefit of PET Scans|The secondary outcome that we are interested in studying is the benefit of PET scan as compared to other imaging modalities, such as CT, MRI, and EUS. Thus, Patients will also have CT, MRI, and EUS imaging. We will look at how size, location, and branch of the IPMN lesion on PET compare to these other imaging modalities. The location, size, and pathology results of the actual surgical specimen will serve as the gold standard.|1 month|The principal investigator has left the institution. Data will not be analyzed. Only the demographic information on 1 enrolled subject is available.|||||
816569|NCT01104116|Primary|Positive and Negative Predictive Value of PET Imaging for Identifying Malignant IPMN|The primary outcome will be to determine the positive and negative predictive values of [18F]-FDG PET imaging for identifying malignant IPMN lesions in patients who are to undergo surgical resection. We will determine the mean SUV that would provide optimal positive predictive value for malignant IPMN. IPMN lesions will be classified categorically as benign (adenoma or borderline ) or malignant (in situ or invasive carcinoma) and PET imaging will be classified categorically as negative or positive, with focal FDG uptake corresponding to pancreatic lesion.|1 month|The principal investigator has left the institution. Data will not be analyzed. Only the demographic information on 1 enrolled subject is available.|||||
816570|NCT01104155|Secondary|Overall Survival (OS)|OS was defined as the length of time in months from the date of first administration of study drug until the date of death from any cause, and was based on the data cutoff date. In the absence of confirmation of death, participants were censored either at the date that the participant was last known to be alive or the date of study cutoff, whichever came first. OS and the corresponding 2-sided 95% CI was analyzed using the Kaplan-Meier method.|From date of first dose of study drug until date of death from any cause or up to data cutoff (31 May 2013), up to approximately 3.25 years|FAS||Months||95% Confidence Interval|Median
816633|NCT01104584|Other Pre-specified|Vital Signs Change From Baseline and Follow–up 24 Hours Post Injection - Systolic and Diastolic Blood Pressure|Systolic and diastolic blood pressure were measured in a supine position. Blood pressure was not to be measured on the arm used for the injection.|Baseline, 24 hours post injection|Safety Analysis Set (SAF): The analysis of safety data was performed using all available data from all participants who administered any amount of gadobutrol.||mmHg||Standard Deviation|Mean
816571|NCT01104155|Secondary|Disease Control Rate (DCR)|DCR was defined as the percentage of participants who had a BOR of CR or PR, or stable disease (SD; duration of SD lasted for at least 7 weeks). To be assigned a BOR of SD, the time from the first administration of study drug until the date of documented SD was to be greater than or equal to 7 weeks (49 days). A participant's tumor assessment had to be at least 7 weeks following the randomization date to be consider SD. DCR and the corresponding exact Clopper-Pearson 95% CI were computed by treatment regimen. (CR + PR + SD)|From date of first dose of study drug until documentation of disease progression or death from any cause (whichever occurred first) or up to data cutoff (31 May 2013), up to approximately 3.25 years|FAS||Percentage of participants||95% Confidence Interval|Number
816572|NCT01104155|Secondary|Progression-Free Survival (PFS)|PFS was measured as the time from the date of first administration of study treatment until the first documentation of disease progression or death (due to any cause), whichever occurred first, as determined by investigator assessment based on RECIST v1.1. Disease progression per RECIST v1.1 was defined as at least a 20% relative increase and 5 mm absolute increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions. For participants who did not have an event (i.e. those who had not progressed, and were alive at the date of data cut-off or lost to Follow-up), progression-free survival was censored. Participants who did not progress in their disease were censored on the date of their last tumor assessment preceding the start of any additional anticancer therapy. PFS was analyzed using the Kaplan-Meier method.|From date of first dose of study drug until documentation of disease progression or death from any cause (whichever occurred first), or up to data cutoff (31 May 2013) up to 3.25 years|FAS||Months||95% Confidence Interval|Median
816573|NCT01104155|Secondary|Duration of Response (DOR)|DOR was assessed for participants with a BOR of CR or PR, and was defined as the time from first documented evidence of CR or PR (whichever status was recorded first) until the first documented sign of disease progression or death (due to any cause), whichever was first. DOR was defined for participants with a confirmed CR or PR. For participants in the subset of responders who did not progress or die, duration of response was censored. DOR was analyzed using the Kaplan-Meier method.|From date of first document CR or PR (whichever was recorded first) until first documentation of disease progression or death due to any cause, or up to data cutoff (31 May 2013) up to 3.25 years|FAS||Months||95% Confidence Interval|Median
816574|NCT01104155|Primary|Objective Response Rate (ORR)|ORR was defined as the percentage of participants whose best overall response (BOR) was either a confirmed complete response (CR) or a partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria for target lesions assessed by computed tomography (CT) or magnetic resonance imaging (MRI) and based on investigator assessment. CRs and PRs had to be confirmed by a repeat assessment of response (CR or PR) separated by at least 4 weeks (28 days). CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (target or non-target) had to have a reduction in short axis to less than 10 millimeters. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR and the corresponding 95% two-sided confidence intervals (CI) were estimated for each treatment regimen using the Clopper-Pearson method for calculating the exact binomial CI. (CR + PR)|From date of first dose of study drug until, or up to the date of data cutoff (07 Apr 2011)|Full analysis set (FAS) (Intent-to-treat population) included all participants who took at least one dose of study drug.||Percentage of participants||95% Confidence Interval|Number
816575|NCT01104207|Primary|Change in Tinnitus Functional Index (TFI) Score|The TFI is a 25-item questionnaire that assesses tinnitus severity. The possible range of scores for the TFI is 0 to 100, with higher scores indicating more severe tinnitus.|26 weeks post-treatment|||units on TFI scale; change from baseline||Standard Deviation|Mean
816576|NCT01104246|Primary|Time-average (Cavg) Steady State Testosterone Concentration Over 24 Hours|A 24-hour pharmacokinetic sampling was performed on Day 28/29 after the start of dosing.|Day 28/29|Per-protocol Population was used for the analysis. PP population included subjects who completed the treatment period of the study, who did not have more than two consecutive missing data, and who did not have any major protocol deviations.||ng/dL||Standard Deviation|Mean
816577|NCT01104285|Primary|Total Days of Mechanical Ventilatory Support||days|||days||Standard Deviation|Mean
816578|NCT01104311|Secondary|Number of Participants With Adverse Events|Number of Participants with Adverse Events|24 Weeks|The number of participants are analyzed by Safety population.||participants|||Number
816579|NCT01104311|Secondary|Number of Participants With Vascular Death From Screening to Week 24 in ITT Population.||24 Weeks|The number of participants are analyzed by ITT population.||participants|||Number
816580|NCT01104311|Secondary|Total Number of Cardiovascular Events Form Screening to Week 24 in ITT Population.||24 Week|The number of participants are analyzed by ITT population.||events|||Number
816581|NCT01104311|Secondary|Number of Participants With Cardiovascular Events From Screening to Week 24 in ITT Population.||24 weeks|The number of participants are analyzed by ITT Population.||participants|||Number
816582|NCT01104311|Secondary|The Number of Patients With New Ischemic Lesion in the Whole Forebrain on FLAIR MRI||24 weeks|The Number of Participants are analyzed by ITT (Intent to treat) Population. ITT Population (Aggressive BP Lowering: 66, Modest BP Lowering: 63)||participants|||Number
816583|NCT01104311|Secondary|Change of the Ischemic Lesion Volume in Cerebral Hemisphere on FLAIR From Screening to Week 24 in FAS Population|the difference between final ischemic lesions volume and base ischemic lesions in the territory of symptomatic intracranial disease on FLAIR MRI|24 weeks|The number of participants are analyzed by FAS population.||cc||Standard Deviation|Mean
816584|NCT01104311|Primary|Ischemic Lesion Volume Change in the Whole Forebrain on Fluid Attenuation Inversion Recovery (FLAIR) Magnetic Resonance Imaging (MRI)|The difference between final ischemic lesions volume and base ischemic lesions of both hemisphere on FLAIR MRI|Screening to 24 weeks|The Number of Participants Analyzed by FAS(Full analysis)Population. FAS Population (Aggressive BP Lowering: 59, Modest BP Lowering: 52)||cc||Standard Deviation|Mean
816585|NCT01104376|Primary|Measure Efavirenz Clearance|Effect of steady-state voriconazole on efavirenz Clearance in healthy volunteers (n=61) administered a single 100 mg oral dose of efavirenz at baseline (control phase) and after treatment with voriconazole to steady-state.|Baseline, 30 min, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24h after efavirenz|||ml/min/kg||Standard Deviation|Mean
816586|NCT01104493|Secondary|Percentage of Participants Reporting at Least One Serious Adverse Event (SAE) or New Onset Chronic Disease (NOCD), Study Days 1-181|SAEs were those that resulted in death; were life-threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly/birth defect in the offspring of a study participant; or were a medical event that may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above. An NOCD was a newly diagnosed medical condition of a chronic, ongoing nature and assessed by the investigator as medically significant.|Study Days 1-181|All subjects who received a single dose of investigational product (monovalent vaccine = 240; placebo = 60)||Percentage of participants|||Number
816587|NCT01104493|Secondary|Percentage of Participants Reporting at Least One Serious Adverse Event (SAE) or New Onset Chronic Disease (NOCD), Study Days 1-29|SAEs were those that resulted in death; were life-threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly/birth defect in the offspring of a study participant; or were a medical event that may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above. An NOCD was a newly diagnosed medical condition of a chronic, ongoing nature and assessed by the investigator as medically significant.|Study Days 1-29|All subjects who received a single dose of investigational product (monovalent vaccine = 240; placebo = 60)||Percentage of participants|||Number
816588|NCT01104493|Secondary|Percentage of Participants Reporting Any Adverse Event.|An adverse event (AE) was defined as: Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Study Days 1-15|All subjects who received a single dose of investigational product (monovalent vaccine = 240; placebo = 60)||Percentage of participants|||Number
816589|NCT01104493|Secondary|Percentage of Participants Reporting Any Solicited Symptom.|Solicited symptoms were events that were considered likely to occur post dosing. Solicited symptoms for this study are listed below.|Study Days 1-15|All subjects who received a single dose of investigational product (monovalent vaccine = 240; placebo = 60)||Percentage of participants|||Number
816590|NCT01104493|Secondary|Percentage of Participants Reporting Any Adverse Event.|An adverse event (AE) was defined as: Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Study Days 1-8|All subjects who received a single dose of investigational product (monovalent vaccine = 240; placebo = 60)||Percentage of participants|||Number
816591|NCT01104493|Secondary|Percentage of Participants Reporting Any Solicited Symptom|Solicited symptoms were events that were considered likely to occur post dosing. Solicited symptoms for this study are listed below.|Study Days 1-8|All subjects who received a single dose of investigational product (monovalent vaccine = 240; placebo = 60)||Percentage of participants|||Number
816592|NCT01104493|Primary|Percentage of Participants Reporting Fever, Defined as Oral Temperature ≥ 101°F|A comparison of the rate of fever (oral temperature ≥ 101°F) reported during the 7 days post administration of investigational product between the monovalent vaccine and placebo groups.|Study Days 1-8|All subjects who received a single dose of investigational product (monovalent vaccine = 240; placebo = 60)||Percentage of participants|||Number
816593|NCT01104558|Secondary|Change From Baseline in Pro-BNP Levels According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT|BNP is a substance secreted from the ventricles or lower chambers of the heart in response to changes in pressure that occur when heart failure develops and worsens. The level of BNP in the blood increases when heart failure symptoms worsen, and decreases when the heart failure condition is stable. The BNP level in a person with heart failure is higher than in a person with normal heart function.|Baseline and Week 26 (or EOT)|"Efficacy ITT population: all enrolled participants; treated with study drug; did not violate inclusion/exclusion criteria; and received primary efficacy assessment at least once after administration. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||pg/mL||Standard Deviation|Mean
816594|NCT01104558|Secondary|Change From Baseline in Pro-BNP Levels According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT|BNP is a substance secreted from the ventricles or lower chambers of the heart in response to changes in pressure that occur when heart failure develops and worsens. The level of BNP in the blood increases when heart failure symptoms worsen, and decreases when the heart failure condition is stable. The BNP level in a person with heart failure is higher than in a person with normal heart function.|Baseline and Week 26 (or EOT)|"Efficacy ITT population: all enrolled participants; treated with study drug; did not violate inclusion/exclusion criteria; and received primary efficacy assessment at least once after administration. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||pg/mL||Standard Deviation|Mean
816595|NCT01104558|Secondary|Change From Baseline in Pro-BNP Levels According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT|BNP is a substance secreted from the ventricles or lower chambers of the heart in response to changes in pressure that occur when heart failure develops and worsens. The level of BNP in the blood increases when heart failure symptoms worsen, and decreases when the heart failure condition is stable. The BNP level in a person with heart failure is higher than in a person with normal heart function.|Baseline and Week 26 (or EOT)|"Efficacy ITT population: all enrolled participants; treated with study drug; did not violate inclusion/exclusion criteria; and received primary efficacy assessment at least once after administration. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||pg/mL||Standard Deviation|Mean
816676|NCT01110252|Primary|Forced Expiratory Volume (FEV1)|A pulmonary function test that measures the volume and speed of the exhaled air.|baseline and 30 days after procedure|all patients were evaluated prior and after the procedure||liters||Standard Deviation|Mean
816596|NCT01104558|Secondary|Change From Baseline in Pro-B-type Natriuretic Peptide (BNP) Levels According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or EOT|BNP is a substance secreted from the ventricles or lower chambers of the heart in response to changes in pressure that occur when heart failure develops and worsens. The level of BNP in the blood increases when heart failure symptoms worsen, and decreases when the heart failure condition is stable. The BNP level in a person with heart failure is higher than in a person with normal heart function.|Baseline and Week 26 (or EOT)|"Efficacy ITT population: all enrolled participants; treated with study drug; did not violate inclusion/exclusion criteria; and received primary efficacy assessment at least once after administration. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||picograms (pg)/ milliliter (mL)||Standard Deviation|Mean
816597|NCT01104558|Secondary|Change From Baseline in DBP (6 MWT- After Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT|The change in DBP was calculated as 6-MWT after walking DBP at Week 26 minus 6-MWT after walking DBP at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||mmHg||Standard Deviation|Mean
816598|NCT01104558|Secondary|Change From Baseline in DBP (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT|The change in DBP was calculated as 6-MWT after walking DBP at Week 26 minus 6-MWT after walking DBP at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||mmHg||Standard Deviation|Mean
816599|NCT01104558|Secondary|Change From Baseline in DBP (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT|The change in DBP was calculated as 6-MWT after walking DBP at Week 26 minus 6-MWT after walking DBP at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||mmHg||Standard Deviation|Mean
816600|NCT01104558|Secondary|Change From Baseline in DBP (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or EOT|The change in DBP was calculated as 6-MWT after walking DBP at Week 26 minus 6-MWT after walking DBP at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||mmHg||Standard Deviation|Mean
816601|NCT01104558|Secondary|Change From Baseline in DBP (6 MWT- Before Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT|The change in DBP was calculated as 6-MWT before walking DBP at Week 26 minus 6-MWT before walking DBP at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||mmHg||Standard Deviation|Mean
816602|NCT01104558|Secondary|Change From Baseline in DBP (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT|The change in DBP was calculated as 6-MWT before walking DBP at Week 26 minus 6-MWT before walking DBP at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||mmHg||Standard Deviation|Mean
816603|NCT01104558|Secondary|Change From Baseline in DBP (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT|The change in DBP was calculated as 6-MWT before walking DBP at Week 26 minus 6-MWT before walking DBP at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||mmHg||Standard Deviation|Mean
816604|NCT01104558|Secondary|Change From Baseline in Diastolic Blood Pressure (DBP) (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or EOT|The change in DBP was calculated as 6-MWT before walking DBP at Week 26 minus 6-MWT before walking DBP at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||mmHg||Standard Deviation|Mean
816605|NCT01104558|Secondary|Change From Baseline in SBP (6 MWT- After Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT|The change in SBP was calculated as 6-MWT after walking SBP at Week 26 minus 6-MWT after walking SBP at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||mmHg||Standard Deviation|Mean
816606|NCT01104558|Secondary|Change From Baseline in SBP (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT|The change in SBP was calculated as 6-MWT after walking SBP at Week 26 minus 6-MWT after walking SBP at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||mmHg||Standard Deviation|Mean
816607|NCT01104558|Secondary|Change From Baseline in SBP (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT|The change in SBP was calculated as 6-MWT after walking SBP at Week 26 minus 6-MWT after walking SBP at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||mmHg||Standard Deviation|Mean
816608|NCT01104558|Secondary|Change From Baseline in SBP (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or EOT|The change in SBP was calculated as 6-MWT after walking SBP at Week 26 minus 6-MWT after walking SBP at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||mmHg||Standard Deviation|Mean
816609|NCT01104558|Secondary|Change From Baseline in SBP (6 MWT- Before Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT|The change in SBP was calculated as 6-MWT before walking SBP at Week 26 minus 6-MWT before walking SBP at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||mmHg||Standard Deviation|Mean
816610|NCT01104558|Secondary|Change From Baseline in SBP (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT|The change in SBP was calculated as 6-MWT before walking SBP at Week 26 minus 6-MWT before walking SBP at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||mmHg||Standard Deviation|Mean
816611|NCT01104558|Secondary|Change From Baseline in SBP (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT|The change in SBP was calculated as 6-MWT before walking SBP at Week 26 minus 6-MWT before walking SBP at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||mmHg||Standard Deviation|Mean
816612|NCT01104558|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or EOT|The change in SBP was calculated as 6-MWT before walking SBP at Week 26 minus 6-MWT before walking SBP at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||millimeters of mercury (mmHg)||Standard Deviation|Mean
816613|NCT01104558|Secondary|Change From Baseline in Heart Rate (6 MWT- After Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT|The change in heart rate was calculated as 6-MWT after walking heart rate at Week 26 minus 6-MWT after walking heart rate at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||bpm||Standard Deviation|Mean
816614|NCT01104558|Secondary|Change From Baseline in Heart Rate (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT|The change in heart rate was calculated as 6-MWT after walking heart rate at Week 26 minus 6-MWT after walking heart rate at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||bpm||Standard Deviation|Mean
816615|NCT01104558|Secondary|Change From Baseline in Heart Rate (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT|The change in heart rate was calculated as 6-MWT after walking heart rate at Week 26 minus 6-MWT after walking heart rate at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||bpm||Standard Deviation|Mean
816616|NCT01104558|Secondary|Change From Baseline in Heart Rate (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or EOT|The change in heart rate was calculated as 6-MWT after walking heart rate at Week 26 minus 6-MWT after walking heart rate at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||bpm||Standard Deviation|Mean
816617|NCT01104558|Secondary|Change From Baseline in Heart Rate (6 MWT- Before Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT|The change in heart rate was calculated as 6-MWT before walking heart rate at Week 26 minus 6-MWT before walking heart rate at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||bpm||Standard Deviation|Mean
816618|NCT01104558|Secondary|Change From Baseline in Heart Rate (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT|The change in heart rate was calculated as 6-MWT before walking heart rate at Week 26 minus 6-MWT before walking heart rate at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||bpm||Standard Deviation|Mean
816619|NCT01104558|Secondary|Change From Baseline in Heart Rate (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT|The change in heart rate was calculated as 6-MWT before walking heart rate at Week 26 minus 6-MWT before walking heart rate at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||bpm||Standard Deviation|Mean
816677|NCT01110252|Primary|Forced Vital Capacity (FVC)|A pulmonary function test that measures the volume and speed of the inhalated air.|baseline and 30 days after procedure|all patients were evaluated prior and after the procedure||liters||Standard Deviation|Mean
816620|NCT01104558|Secondary|Change From Baseline in Heart Rate (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or EOT|The change in heart rate was calculated as 6-MWT before walking heart rate at Week 26 minus 6-MWT before walking heart rate at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||Beats per minute (bpm)||Standard Deviation|Mean
816621|NCT01104558|Secondary|Change From Baseline in 6-minute Walking Test (6-MWT) Distance According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT|6 MWT distance was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||Meter||Standard Deviation|Mean
816622|NCT01104558|Secondary|Change From Baseline in 6-MWT Distance According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT|6 MWT distance was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||Meter||Standard Deviation|Mean
816623|NCT01104558|Primary|Change From Baseline in Echocardiographic LVEF According to the Genetic Polymorphism of G Protein-coupled Receptor Kinase 5 (GRK5)-AG at Week 26 or EOT||Baseline and Week 26 (or EOT)|"Efficacy ITT population: all enrolled participants; treated with study drug; did not violate inclusion/exclusion criteria; and received primary efficacy assessment at least once after administration. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||Percent LVEF||Standard Deviation|Mean
816624|NCT01104558|Primary|Change From Baseline in Echocardiographic LVEF According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT||Baseline and Week 26 (or EOT)|"Efficacy ITT population: all enrolled participants; treated with study drug; did not violate inclusion/exclusion criteria; and received primary efficacy assessment at least once after administration. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||Percent LVEF||Standard Deviation|Mean
816625|NCT01104558|Primary|Change From Baseline in Echocardiographic LVEF According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT||Baseline and Week 26 (or EOT)|"Efficacy ITT population: all enrolled participants; treated with study drug; did not violate inclusion/exclusion criteria; and received primary efficacy assessment at least once after administration. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||Percent LVEF||Standard Deviation|Mean
816626|NCT01104558|Secondary|Change From Baseline in 6-MWT Distance According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT|6 MWT distance was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||Meter||Standard Deviation|Mean
816627|NCT01104558|Secondary|Change From Baseline in 6-minute Walking Test (6-MWT) Distance According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or EOT|6 MWT distance was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||Meter||Standard Deviation|Mean
816628|NCT01104558|Secondary|Duration of Hospitalization Due to Heart Failure||Baseline to Week 26 (or EOT)|Participant analyzed included 1 participant from the efficacy ITT population who was hospitalized once due to heart failure.||Days|||Number
816629|NCT01104558|Secondary|Number of Participants With Hospitalization Due to Heart Failure||Baseline to Week 26 (or EOT)|Efficacy ITT population: all enrolled participants; treated with study drug; did not violate inclusion/exclusion criteria; and received primary efficacy assessment at least once after administration.||Participants|||Number
816630|NCT01104558|Primary|Change From Baseline in Echocardiographic Left Ventricular Ejection Fraction (LVEF) According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or End of Treatment (EOT)||Baseline and Week 26 (or EOT)|"Efficacy intention to treat (ITT) population: all enrolled participants; treated with study drug; did not violate inclusion/exclusion criteria; and received primary efficacy assessment at least once after administration. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||Percent LVEF||Standard Deviation|Mean
816631|NCT01104584|Other Pre-specified|Number of Participants With at Least One Laboratory Parameter Change From Low or Normal at Baseline to Abnormally High at Follow–up 24 Hours Post Injection|Number of participants with at least one occurrence of changing from low or normal at baseline to high at follow-up.|Baseline, Follow–up visit (24 hours post injection)|Safety Analysis Set (SAF): The analysis of safety data was performed using all available data from all participants who administered any amount of gadobutrol.||Participants|||Number
816632|NCT01104584|Other Pre-specified|Vital Signs Change From Baseline and Follow–up 24 Hours Post Injection - Heart Rate|Heart rate was measured in a supine position.|Baseline, Follow–up visit (24 hours post injection)|Safety Analysis Set (SAF): The analysis of safety data was performed using all available data from all participants who administered any amount of gadobutrol.||beats/min||Standard Deviation|Mean
816694|NCT01114945|Primary|Glottis View Using the Cormack Lehane Score|"Cormack Lehane score classification:
Grade 1: Most of the glottis is visible Grade 2: At best almost half of the glottis is seen, at worst only the posterior tip of the arytenoids is seen Grade 3: Only the epiglottis is visible Grade 4: No laryngeal structures are visible"|Up to 1 minute|Cormack Lehane score (grade:1/2/3/4 [n])||participants|||Number
816634|NCT01104584|Other Pre-specified|Categorical Accuracy Difference of Extent of Malignant Disease Verified by Histopathology by Majority Reader, Breast Region Level||Immediately before injection and after injection|"The Statistical Analysis Plan (SAP) amendment re-defined study objectives and replaced protocol-defined parameters such as categorical accuracy prior to database closure and breaking the blind. The SAP amendment is based upon review of results of an identical clinical study within the GEMMA program and also includes advice from the FDA."|||||
816635|NCT01104584|Other Pre-specified|Categorical Accuracy Difference of Extent of Malignant Disease Verified by SoT by Majority Reader, Breast Region Level||Immediately before injection and after injection|"The Statistical Analysis Plan (SAP) amendment re-defined study objectives and replaced protocol-defined parameters such as categorical accuracy prior to database closure and breaking the blind. The SAP amendment is based upon review of results of an identical clinical study within the GEMMA program and also includes advice from the FDA."|||||
816636|NCT01104584|Other Pre-specified|Blinded Reader 3: Intra-reader Variability Based on Assessment for CMRM - Breast Level|Intra-reader variability was assessed using a kappa on the match to SoT for the different regions within each participant (match, no match SoT). For each of the 3 readers, intra-reader agreement was assessed by considering each breast region to have 2 possibilities for an assessment by CMRM: matched SoT or did not match SoT. Kappa value varies from 0 (no agreement) to 1 (perfect agreement).|Immediately before injection and after injection|All participants in the FAS with assessments for this outcome measure||Kappa|Participants||Number
816637|NCT01104584|Other Pre-specified|Blinded Reader 2: Intra-reader Variability Based on Assessment for CMRM - Breast Level|Intra-reader variability was assessed using a kappa on the match to SoT for the different regions within each participant (match, no match SoT). For each of the 3 readers, intra-reader agreement was assessed by considering each breast region to have 2 possibilities for an assessment by CMRM: matched SoT or did not match SoT. Kappa value varies from 0 (no agreement) to 1 (perfect agreement).|Immediately before injection and after injection|All participants in the FAS with assessments for this outcome measure.||Kappa|Participants||Number
816638|NCT01104584|Other Pre-specified|Blinded Reader 1: Intra-reader Variability Based on Assessment for CMRM - Breast Level|Intra-reader variability was assessed using a kappa on the match to SoT for the different regions within each participant (match, no match SoT). For each of the 3 readers, intra-reader agreement was assessed by considering each breast region to have 2 possibilities for an assessment by CMRM: matched SoT or did not match SoT. Kappa value varies from 0 (no agreement) to 1 (perfect agreement).|Immediately before injection and after injection|All participants in the FAS with assessments for this outcome measure.||Kappa|Participants||Number
816639|NCT01104584|Other Pre-specified|Blinded Readers: Inter-reader Agreement on Sensitivity Based on Assessment for UMRM vs CMRM - Breast Region Level|Inter-reader agreement was assessed by considering each breast region to have 2 possibilities (malignant disease / no malignant disease) for an assessment by the 2 image sets (UMRM and CMRM). Kappa value varies from 0 (no agreement) to 1 (perfect agreement).|Immediately before injection and after injection|All participants in the FAS with assessments for this outcome measure||Kappa|Participants||Number
816640|NCT01104584|Other Pre-specified|Accuracy Difference of Presence of Bilateral Malignant Disease Verified by SoT by Clinical Investigator, Participant Level|The disease state “bilateral malignant disease” was derived from the assessment of the different regions for each breast (right and left) for investigators for each imaging modality (UMRM, CMRM, XRM, UMRM+XRM, and CMRM+XRM) based on the following rule: If the participant had at least one breast with no malignant region , the assessment of bilateral malignant disease was categorized as “No”. If the participant had at least one malignant lesion in both breasts, the assessment of bilateral malignant disease was categorized as “Yes”. The proportion of correct matches of each different image set to the SoT for the existence of bilateral malignant disease were derived. The analysis was based on the difference in accuracy for the evaluation of bilateral malignant disease for the following image comparisons on a participant level. The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|The analyses were based on 380 participants in FAS; evaluable subjects with at least one region verified by SoT in each breast with available CMRM, UMRM, CMRM+XRM, UMRM+XRM and XRM assessment.||difference in accuracy (%)||95% Confidence Interval|Mean
816641|NCT01104584|Other Pre-specified|Sensitivity of Detection of Multicentric Malignant Disease Verified by SoT, Breast Level|For a single participant the sensitivity was defined as the proportion of malignant breast regions that were recognized by the reader using the respective imaging modality as malignant. Subsequently the point estimates were calculated based on the mean of the sensitivities across all participants. The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|All participants in the FAS with assessments for this outcome measure||difference in sensitivity (%)|Participants|95% Confidence Interval|Mean
816642|NCT01104584|Other Pre-specified|Specificity Difference in the Determination of Multifocal Malignant Breast Disease Using CMRM vs UMRM, CMRM+XRM vs UMRM+XRM, and CMRM+XRM vs XRM Verified by SoT, Breast Region Level|A malignant breast was defined as FP, when the reader using the respective imaging modality assessed more breast regions as malignant as were present according to SoT. Otherwise the breast was assessed as TN. Specificity was then defined as TN/(TN+FP). The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|All participants in the FAS with assessments for this outcome measure||difference in specificity (%)|Participants|95% Confidence Interval|Mean
816643|NCT01104584|Other Pre-specified|Specificity Difference in the Determination of Unifocal Malignant Breast Disease Using CMRM vs UMRM, CMRM+XRM vs UMRM+XRM, and CMRM+XRM vs XRM Verified by SoT, Breast Region Level|A malignant breast was defined as FP, when the reader using the respective imaging modality assessed more breast regions as malignant as were present according to SoT. Otherwise the breast was assessed as TN. Specificity was then defined as TN/(TN+FP). The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|All participants in the FAS with assessments for this outcome measure||difference in specificity (%)|Participants|95% Confidence Interval|Mean
816744|NCT01115582|Secondary|Blood Pressure|Systolic blood pressure (SBP) and diastolic blood pressure (DBP)|At baseline and after 30 days of treatment|All patients entered and treated||mmHg||Standard Deviation|Mean
816644|NCT01104584|Other Pre-specified|Specificity Difference in the Determination of Malignant Breast Disease Using CMRM vs UMRM, CMRM+XRM vs UMRM+XRM, and CMRM+XRM vs XRM Verified by SoT, Breast Region Level|A malignant breast was defined as FP, when the reader using the respective imaging modality assessed more breast regions as malignant as were present according to SoT. Otherwise the breast was assessed as TN. Specificity was then defined as TN/(TN+FP). The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|All participants in the FAS with assessments for this outcome measure||difference in specificity (%)|Participants|95% Confidence Interval|Mean
816645|NCT01104584|Other Pre-specified|Sensitivity Difference in the Determination of Multifocal Malignant Breast Disease Using CMRM vs UMRM, CMRM+XRM vs UMRM+XRM, and CMRM+XRM vs XRM Verified by SoT, Breast Region Level|For a single participant the sensitivity was defined as the proportion of malignant breast regions that were recognized by the reader using the respective imaging modality as malignant. Subsequently the point estimates were calculated based on the mean of the sensitivities across all participants. The difference in sensitivity is calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|All participants in the FAS with assessments for this outcome measure||difference in sensitivity (%)|Participants|95% Confidence Interval|Mean
816646|NCT01104584|Other Pre-specified|Sensitivity Difference in the Determination of Unifocal Malignant Breast Disease Using CMRM vs UMRM, CMRM+XRM vs UMRM+XRM, and CMRM+XRM vs XRM Verified by SoT, Breast Region Level|For a single participant the sensitivity was defined as the proportion of malignant breast regions that were recognized by the reader using the respective imaging modality as malignant. Subsequently the point estimates were calculated based on the mean of the sensitivities across all participants. The difference in sensitivity is calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|All participants in the FAS with assessments for this outcome measure||difference in sensitivity (%)|Participants|95% Confidence Interval|Mean
816647|NCT01104584|Other Pre-specified|Sensitivity Difference in the Determination of Malignant Breast Disease Using CMRM vs UMRM, CMRM+XRM vs UMRM+XRM, and CMRM+XRM vs XRM Verified by SoT, Breast Region Level|For a single participant the sensitivity was defined as the proportion of malignant breast regions that were recognized by the reader using the respective imaging modality as malignant. Subsequently the point estimates were calculated based on the mean of the sensitivities across all participants. Regions with malignant disease verified by SoT comprise unifocal and multifocal regions. Difference in sensitivity is calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|All participants in the FAS with assessments for this outcome measure||difference in sensitivity (%)|Participants|95% Confidence Interval|Mean
816648|NCT01104584|Other Pre-specified|Breast Level Specificity for All Breasts by Imaging Modality and by Reader|A non-malignant breast was defined as FP when the reader assessed at least one breast region as malignant. A malignant breast was defined as FP, when the reader using the respective imaging modality assessed more breast regions as malignant as were present according to SoT. Otherwise the breast was assessed as TN. Specificity was then defined as (N-FP)/N, where N was total number of breasts.|Immediately before injection and after injection|The analyses were based on 395 participants in FAS; evaluable for specificity were breasts with or without malignant disease verified by SoT with available assessments by the imaging modality.||specificity (%)||95% Confidence Interval|Mean
816649|NCT01104584|Other Pre-specified|Breast Level Specificity in Malignant Breasts Using UMRM, XRM, CMRM+XRM and UMRM+XRM by Reader|A malignant breast was defined as FP, when the reader using the respective imaging modality assessed more breast regions as malignant as were present according to SoT. Otherwise the breast was assessed as TN. Specificity was then defined as TN/(TN+FP).|Immediately before injection and after injection|The analyses were based on 390 participants; evaluable for specificity were breasts with malignant disease verified by SoT for which an assessment by the imaging modality was available.||specificity (%)||95% Confidence Interval|Mean
816650|NCT01104584|Other Pre-specified|Breast Level Specificity of in Non-malignant Breasts Using UMRM, XRM, CMRM+XRM and UMRM+XRM by Reader|A non-malignant breast was defined as false positive (FP), when the reader assessed at least one breast region as malignant. When all breast regions were assessed as non-malignant, the breast was defined as true negative (TN). Breast level specificity was first defined in participant as number of TN-breasts in participant divided by number of non-malignant breasts in participant. Subsequently the specificity percentage was calculated based on the mean of the specificities across all participants who contributed with at least one non-malignant breast.|Immediately before injection and after injection|The analyses were based on 367 participants; evaluable for specificity were breasts with no malignant disease verified by SoT for which an assessment of the imaging modality was available.||specificity (%)||95% Confidence Interval|Mean
816651|NCT01104584|Other Pre-specified|Sensitivity for Detection of Full Extent of Malignant Breast Disease Using XRM, CMRM+XRM and UMRM+XRM Per Reader|For a single participant the sensitivity was defined as the proportion of malignant breast regions that were recognized by the reader using the respective imaging modality as malignant. Subsequently the sensitivity percentage was calculated based on the mean of the sensitivities across all participants.|Immediately before injection and after injection|The analyses were performed for a total number of 390 participants who had regions with malignant disease verified by SoT with available assessment by the imaging modality.||sensitivity (%)||95% Confidence Interval|Mean
816652|NCT01104584|Secondary|Difference of Confidence in Diagnosis for Breast Region Diagnosis Using CMRM vs UMRM, CMRM+XRM vs UMRM+XRM and CMRM+XRM vs XRM by Reader, Participant Level|The investigator and the blinded readers each recorded his/her confidence in diagnosis for each breast region based on a 4-point scale (1 = not confident, 2 = somewhat confident, 3 = confident, and 4 = very confident). For each participant, the mean of the confidence responses for the diagnosed breast regions was calculated, and rounded to the nearest 0.5. The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|All participants in the FAS with assessments for this outcome measure||difference of scores on a scale||95% Confidence Interval|Mean
816745|NCT01115582|Secondary|Adverse Events|Total number of patients with any adverse events|Total of 30 days, i.e. from the time point the patients entered into the study up to the end of treatment|All patients entered and treated||participants|||Number
816653|NCT01104584|Secondary|Percentage Difference of Participants Whose Additional Index Cancers Were Detected Using CMRM vs UMRM, CMRM vs XRM, and CMRM vs CMRM+XRM|Additional cancer was defined as cancer which was present according to SoT, but which was not defined as index cancer, i.e. was not known when the participant was enrolled into the study. The difference in percentage of participants was calculated as CMRM value minus UMRM value, CMRM value minus XRM value, CMRM value minus CMRM+XRM value respectively.|Immediately before injection and after injection|The evaluation was based on the 84 participants in the FAS who had at least one additional cancer region according to SoT.||difference in percentage of participants||95% Confidence Interval|Number
816654|NCT01104584|Secondary|Percentage Difference of Participants Whose Index Cancers Were Detected Using CMRM vs UMRM, CMRM vs XRM, and CMRM vs CMRM+XRM|Index cancer was defined as the cancer confirmed by histology prior to inclusion which made the participants eligible for the study. The difference in percentage of participants was calculated as CMRM value minus UMRM value, CMRM value minus XRM value, CMRM value minus CMRM+XRM value respectively.|Immediately before injection and after injection|The analyses were based on 388 participants in FAS; index cancer was defined as the cancer confirmed by histology prior to inclusion which made the participant eligible for the study.||difference in percentage of participants||95% Confidence Interval|Number
816655|NCT01104584|Secondary|Breast Level Specificity of CMRM Based on Malignant Breasts|A malignant breast was defined as FP, when the reader using the respective imaging modality assessed more breast regions as malignant as were present according to SoT. Otherwise the breast was assessed as TN. Specificity was then defined as TN/(TN+FP).|Immediately before injection and after injection|The analyses were based on 390 participants in FAS; evaluable for specificity were breasts with malignant disease verified by SoT for which an assessment by the imaging modality was available.||specificity (%)||95% Confidence Interval|Mean
816656|NCT01104584|Primary|Breast Level Specificity of CMRM for Non-malignant Breasts by Reader|A non-malignant breast was defined as false positive (FP), when the reader assessed at least one breast region as malignant. When all breast regions were assessed as non-malignant, the breast was defined as true negative (TN). Breast level specificity was first defined in participant as number of TN-breasts in participant divided by number of non-malignant breasts in participant. Subsequently the specificity percentage was calculated based on the mean of the specificities across all participants who contributed with at least one non-malignant breast.|Immediately before injection and after injection|The analyses were based on 367 participants in FAS; evaluable for specificity were breasts without malignant disease as verified by Standard of Truth (SoT) for which a CMRM assessment was available.||specificity (%)||95% Confidence Interval|Mean
816657|NCT01104584|Primary|Sensitivity for Detection of Full Extent of Malignant Breast Disease Using CMRM vs UMRM Per Reader|For a single participant the sensitivity was defined as the proportion of malignant breast regions that were recognized by the clinical investigators and the 3 blinded readers using the respective imaging modality as malignant. Subsequently the sensitivity percentage was calculated based on the mean of the sensitivities across all participants.|Immediately before injection and after injection|The analyses were based on 390 participants in the Full Analysis Set (FAS) who had regions with malignant disease verified by Standard of Truth (SoT).||sensitivity (%)||95% Confidence Interval|Mean
816658|NCT01104584|Primary|Difference of Sensitivity for Detection of Full Extent of Malignant Breast Disease Using CMRM vs UMRM Per Reader|For a single participant the sensitivity was defined as the proportion of malignant breast regions that were recognized by the clinical investigators and the 3 blinded readers using the respective imaging modality as malignant. Subsequently the sensitivity percentage was calculated based on the mean of the sensitivities across all participants. The difference was calculated as CMRM value minus UMRM value. For ease of expression, the following abbreviations will be used: Magnetic Resonance Mammography (MRM), Unenhanced MRM (UMRM), combined unenhanced and contrast (gadobutrol)-enhanced MRM (CMRM), X-ray mammography (XRM).|Immediately before injection and after injection|The analyses were based on 390 participants in the Full Analysis Set (FAS) who had regions with malignant disease verified by Standard of Truth (SoT).||difference in sensitivity (%)||95% Confidence Interval|Mean
816659|NCT01104636|Secondary|Level of Nicotine Dependence Measured by the Fagerstrom Test|Fagerstrom Test for Nicotine Dependence (FTND) was designed to provide measure of nicotine dependence related to cigarette smoking. It contains 4 yes-no and 2 multiple choice questions. Items are scored 0-3 for multiple choice items, items are summed to yield total score of 0-10 (0=minimum to 10=maximum nicotine dependence).|Baseline|The all participants’ population included all enrolled participants who had received at least 1 dose (including partial doses) of study medication. Missing observations were not imputed and hence the participants analyzed are the ones without missing values.||Scores on a scale||Standard Deviation|Median
816660|NCT01104636|Primary|Percentage of Participants Who Abstained From Smoking at Week 12|The use of nicotine was recorded using Nicotine Use Inventory (NUI) to determine the participants who abstained from smoking for the previous 7 days. A responder for the 7-day point prevalence was defined as those with ‘no’ answers to the following two questions: Did the participant smoke any cigarettes (even a puff) in the last 7 days; and did participant use any other tobacco products (example pipe, cigars, snuff, chewing tobacco) in the last 7 days.|Week 12|The all participants' population included all enrolled participants who had received at least 1 dose (including partial doses) of study medication. Missing observations were not imputed and hence the participants analyzed are the ones without missing values.||percentage of participants||95% Confidence Interval|Number
816661|NCT01104662|Secondary|Overall Therapeutic Outcome at Test of Cure (TOC)/Safety Visit|"Participants were assigned a Sponsor-assessed clinical outcome based on the following definitions at the TOC/Safety visit:
Failure: Assessed as a failure at any time by the Investigator or received non-study antimicrobial therapy for lack of efficacy or had the primary site of infection removed completely by surgery or underwent surgery to treat the infection >4 days after starting study medication.
Success: Were not assessed as a failure at any time and were assessed as a cure or improvement by the Investigator at the TOC visit.
Non-evaluable: Received potentially effective antimicrobial therapy during the study period for reasons other than lack of efficacy or received <4 days of study medication or were not assessed by the Investigator."|Baseline through TOC/Safety Visit|Participants who received at least 1 dose of study drug and had at least 1 Gram-positive baseline infecting pathogen for cSSSI participants or S. aureus bacteremia for bacteremia participants.||participants|||Number
833438|NCT01258049|Secondary|PRR 24 [MITT Population]|The percentage reduction in parasite counts 24 hours after first dose|28 days after start of treatment|||percentage of baseline||Standard Deviation|Mean
816662|NCT01104662|Primary|Number of Participants With Treatment-emergent Creatine Phosphokinase (CPK) Elevations Through End of Therapy/Early Termination (EOT/ET)|The number of participants with CPK elevations of >500 units per liter (U/L) above baseline at any time from Day 1 through the EOT/ET visit are presented.|Baseline through EOT/ET|Participants who received at least 1 dose of study drug and had a baseline CPK value and at least 1 post-baseline CPK assessment between Day 1 post-dosing and EOT visit.||participants|||Number
816663|NCT01110135|Primary|Successful Mobilization and Collection of PBSCs|Count of participants with successful mobilization and collection of PBSCs. Defined as collection of > 2 x 10^6 CD34/kg. The current study will be deemed to be potentially efficacious if the observed rate of success is at least 80%.|Within 7 days of apheresis and within 6 weeks of receiving bendamustine hydrochloride|||Participants|||Count of Participants
816664|NCT01110187|Secondary|Number of Participants With Seizures|Number of seizures in the first 72 hours based on EEG recording|baseline to 72 hours|||number of participants with seizures|||Number
816665|NCT01110187|Primary|Number of Adverse Events|The primary outcome measure is the incidence of clinical adverse events. These will be followed by daily clinical observations during the hospital stay. Subjects will be evaluated for e.g., seizures, fever, neurological changes, cardiovascular, hematologic and dermatologic abnormalities, liver failure, renal failure, and death; EKGs will be requested as per ICU routines through day 7.|baseline to 7 days|all participants in each arm were available for analyses||number of events experienced|||Number
816666|NCT01110200|Secondary|Number of EXs of COPD Requiring Treatment With OCSs, Treatment With ABs, and/or Hospitalization (Alone and in Combination)|A COPD EX was defined as the worsening of >=2 major symptoms (dyspnoea, sputum volume, sputum purulence [containing/discharging pus]) or the worsening of any 1 major symptom together with any 1 minor symptom (sore throat, cold [nasal discharge and/or nasal conjestion], fever without other cause, increased cough or wheeze) for at least 2 consecutive days. COPD EXs were identified by symptom review, and/or were based on investigator judgment (via phone contact or at a clinic visit).|From Baseline up to Week 29, approximately|ITT Population. Only those participants with an EX were assessed for hospitalization, treatment with OCSs, and treatment with ABs.||exacerbations|||Number
816667|NCT01110200|Secondary|Number of Participants With an EX of COPD Requiring Treatment With OCSs, Treatment With ABs, and/or Hospitalization|A COPD EX was defined as the worsening of >=2 major symptoms (dyspnoea, sputum volume, sputum purulence [containing/discharging pus]) or the worsening of any 1 major symptom together with any 1 minor symptom (sore throat, cold [nasal discharge and/or nasal conjestion], fever without other cause, increased cough or wheeze) for at least 2 consecutive days. COPD EXs were identified by symptom review, and/or were based on investigator judgment (via phone contact or at a clinic visit).|From Baseline up to Week 29, approximately|ITT Population||participants|||Number
816668|NCT01110200|Primary|Number of EXs of COPD Requiring Hospitalization That Occurred More Than 21 Days Post-discharge or Physician's Office Visit for an EX of COPD Requiring Treatment With OCSs or OCSs and ABs|A COPD EX was defined as the worsening of >=2 major symptoms (dyspnoea, sputum volume, sputum purulence [containing/discharging pus]) or the worsening of any 1 major symptom together with any 1 minor symptom (sore throat, cold [nasal discharge and/or nasal conjestion], fever without other cause, increased cough or wheeze) for at least 2 consecutive days. COPD EXs were identified by symptom review, and/or were based on investigator judgment (via phone contact or at a clinic visit). Hospitalization had to occur more than 21 days post-discharge or physician’s office visit for a prior COPD EX.|From 21 days post-discharge (hospital or emergency room) or physician's office visit, up to 29 weeks|ITT Population. Only those participants with an EX requiring hospitalization were assessed.||Exacerbations|||Number
816669|NCT01110200|Primary|Number of Participants With the Indicated Number of EXs of COPD Requiring Hospitalization That Occurred More Than 21 Days Post-discharge or Physician's Office Visit for an EX of COPD Requiring Treatment With OCSs or OCSs and ABs|A COPD EX was defined as the worsening of >=2 major symptoms (dyspnoea, sputum volume, sputum purulence [containing/discharging pus]) or the worsening of any 1 major symptom together with any 1 minor symptom (sore throat, cold [nasal discharge and/or nasal conjestion], fever without other cause, increased cough or wheeze) for at least 2 consecutive days. COPD EXs were identified by symptom review, and/or were based on investigator judgment (via phone contact or at a clinic visit). Hospitalization had to occur more than 21 days post-discharge or physician’s office visit for a prior COPD EX.|From 21 days post-discharge (hospital or emergency room) or physician's office visit, up to 29 weeks|ITT Population||participants|||Number
816670|NCT01110200|Primary|Number of Par. With Chronic Obstructive Pulmonary Disease (COPD) EXs Requiring Hospitalization That Occurred >21 Days Post-discharge/Physician's Office Visit for a COPD EX Requiring Treatment With Oral Corticosteroids (OCSs) or OCSs and Antibiotics (ABs)|A COPD exacerbation (EX) was defined as the worsening of >=2 major symptoms (dyspnoea, sputum volume, sputum purulence [containing/discharging pus]) or the worsening of any 1 major symptom together with any 1 minor symptom (sore throat, cold [nasal discharge and/or nasal conjestion], fever without other cause, increased cough or wheeze) for at least 2 consecutive days. COPD EXs were identified by symptom review, and/or were based on investigator judgment (via phone contact or at a clinic visit). Hospitalization had to occur >21 days post-discharge/physician’s office visit for a prior COPD EX.|From 21 days post-discharge (hospital or emergency room) or physician's office visit, up to 29 weeks|Intent-to-Treat (ITT) Population: all participants randomized to study drug||participants|||Number
816671|NCT01110239|Primary|Visual Analog Scale Score as a Measure of Tolerability|The visual analogue scale is a pain scale from 0-10, with 10 being maximum pain and is frequently used in research studies assessing patient discomfort.|90 days|We escalated the ischemia times in cohorts of 6. Cohorts of 6 were prespecified at the beginning to the study. All analysis was intention to treat||units on a scale||Standard Deviation|Mean
816672|NCT01110239|Primary|Number of Patients With Deep Vein Thrombosis for Safety Assessment.||90 days|||participants|||Number
816673|NCT01110252|Primary|Vital Capacity - VC|A pulmonary function test that measures the volume and speed of the inhalated and exhaled air.|baseline and 30 days after the procedure|all patients were evaluated prior and after the procedure.||liters||Standard Deviation|Mean
816674|NCT01110252|Secondary|Arterial Blood Gases Test - Pa CO2|presence of CO2 in the arterial blood.|baseline and 30 days after the procedure|all patients were evaluated prior and after the procedure||mm Hg||Standard Deviation|Mean
816675|NCT01110252|Secondary|Arterial Blood Gases Test - Pa O2|presence of oxygen in the blood gases.|baseline and 30 days after procedure|all patients were evaluated prior and after the procedure.||mmHg||Standard Deviation|Mean
816678|NCT01110330|Secondary|The Number of Patients in the Positive Baseline Culture Set (PBCS) With Overall Cure (OC) at Week 6|Overall Cure (OC) was defined as Mycological Cure (MC) in addition to a global clinical evaluation of either ‘Completely Cleared’ (clearance of all signs and symptoms of Tinea pedis) or ‘Marked Improvement’ (significant improvement of signs and symptoms of Tinea pedis; residual signs and symptoms only), assessed at Week 6.|Week 6|Only patients who had a positive Tinea pedis culture at baseline, ie 281 patients, were included in the Positive Baseline Culture Set (PBCS), which was the set used for analysis of the Secondary Outcome Measure.||participants|||Number
816679|NCT01110330|Primary|The Number of Patients in the Positive Baseline Culture Set (PBCS) With Mycological Cure (MC) at Week 6|Mycological Cure (MC) was defined as having a negative potassium hydroxide (KOH) microscopy and negative fungal culture at Week 6.|Week 6|Only patients who had a positive Tinea pedis culture at baseline, ie 281 patients, were included in the Positive Baseline Culture Set (PBCS), which was the set used for analysis of the Primary Outcome Measure.||participants|||Number
816680|NCT01110382|Secondary|Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at Late Follow-Up (LFU) Visit|A total of 24 pathogens in the doripenem group and 6 pathogens in the meropenem group were isolated at baseline from the intra-abdominal culture and were susceptible to the study drug received. The most common pathogens isolated at baseline from the intra-abdominal culture are listed in the table below; the numbers in parenthesis next to each pathogen represent the number of participants with the pathogen isolated in the doripenem and meropenem treatment groups, respectively. The favorable per-pathogen microbiological outcome was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment).|LFU (28 to 42 days after the last dose of study medication therapy)|Microbiological intent-to-treat - Participants of CITT with at least 1 baseline bacterial pathogen isolated from the intra-abdominal cavity that was susceptible to both doripenem and meropenem. 8 and 2 participants from doripenem and meropenem, respectively had no susceptible intra-abdominal pathogen at baseline and were excluded from this set.||participants|||Number
816681|NCT01110382|Secondary|Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at Test Of Cure (TOC) Visit|A total of 24 pathogens in the doripenem group and 6 pathogens in the meropenem group were isolated at baseline from the intra-abdominal culture and were susceptible to the study drug received. The most common pathogens isolated from the intra-abdominal culture are listed in the table below; the numbers in parenthesis next to each pathogen represent the number of participants with the pathogen isolated at baseline in the doripenem and meropenem treatment groups, respectively. The favorable per-pathogen microbiological outcome was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment).|TOC (7 to 14 days after the last dose of study medication therapy)|Microbiological intent-to-treat - Participants of CITT with at least 1 baseline bacterial pathogen isolated from the intra-abdominal cavity that was susceptible to both doripenem and meropenem. 8 and 2 participants from doripenem and meropenem, respectively had no susceptible intra-abdominal pathogen at baseline and were excluded from this set.||participants|||Number
816682|NCT01110382|Secondary|Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at End of IV (EIV) Visit|A total of 24 pathogens in the doripenem group and 6 pathogens in the meropenem group were isolated at baseline from the intra-abdominal culture and were susceptible to the study drug received. The most common pathogens isolated from the intra-abdominal culture are listed in the table below; the numbers in parenthesis next to each pathogen represent the number of participants with the pathogen isolated at baseline in the doripenem and meropenem treatment groups, respectively. The favorable per-pathogen microbiological outcome was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment).|EIV (within 24 hours after completion of the last dose of IV study medication therapy)|Microbiological intent-to-treat - Participants of CITT with at least 1 baseline bacterial pathogen isolated from the intra-abdominal cavity that was susceptible to both doripenem and meropenem. 8 and 2 participants from doripenem and meropenem, respectively had no susceptible intra-abdominal pathogen at baseline and were excluded from this set.||participants|||Number
816683|NCT01110382|Secondary|The Number of Participants With Favorable Per-participant Microbiological Response|Favorable per-participant microbiological response rate was evaluated at the at End of IV (EIV) visit, Test Of Cure (TOC) visit, and Late Follow-Up (LFU) visit. The favorable per-participant microbiological response was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment).|EIV (within 24 hours after completion of the last dose of IV study medication therapy), TOC (7 to 14 days after the last dose of study medication therapy), and LFU (28 to 42 days after the last dose of study medication therapy)|Microbiological intent-to-treat - Participants of CITT with at least 1 baseline bacterial pathogen isolated from the intra-abdominal cavity that was susceptible to both doripenem and meropenem. 8 and 2 participants from doripenem and meropenem, respectively had no susceptible intra-abdominal pathogen at baseline and were excluded from this set.||participants|||Number
816684|NCT01110382|Secondary|The Number of Participants With Clinical Cure Rate at Late Follow-Up (LFU) Visit|The participants were considered as clinical cure if they had clinical improvement in signs and symptoms of the intra-abdominal infection such that no additional antibacterial therapy or surgical or percutaneous intervention is/was required for the treatment of the index infection, no fever, and a favorable response at End of IV visit.|LFU (28 to 42 days after the last dose of study medication therapy)|Clinical Intent-to-Treat (CITT): All randomized participants who met the minimal disease definition of complicated intra-abdominal infection regardless if a baseline pathogen was isolated from the intra-abdominal cavity.||participants|||Number
816685|NCT01110382|Secondary|The Number of Participants With Clinical Improvement Rate at End of IV (EIV) Visit|The participants were considered as clinical improved if they had clinical improvement in signs and symptoms of the intra-abdominal infection, no fever, decrease in WBC, and not received any nonstudy antibiotics for the treatment of intra-abdominal infection after IV study drug therapy had begun.|EIV (within 24 hours after completion of the last dose of IV study medication therapy)|Clinical Intent-to-Treat (CITT): All randomized participants who met the minimal disease definition of complicated intra-abdominal infection regardless if a baseline pathogen was isolated from the intra-abdominal cavity.||participants|||Number
816686|NCT01110382|Primary|The Number of Participants With Clinical Cure Rate at Test Of Cure (TOC) Visit|The participants were considered as clinical cure if they had clinical improvement in signs and symptoms of the intra-abdominal infection such that no additional antibacterial therapy or surgical or percutaneous intervention is/was required for the treatment of the index infection, no fever, and a favorable response at End of IV visit.|TOC (7 to 14 days after the last dose of study medication therapy)|Clinical Intent-to-Treat (CITT): All randomized participants who met the minimal disease definition of complicated intra-abdominal infection regardless if a baseline pathogen was isolated from the intra-abdominal cavity.||participants|||Number
816687|NCT01110408|Secondary|Number of Participants With Sustained Favorable Per-pathogen Microbiological Outcome Rate at Late Follow-Up (LFU) Visit|The sustained favorable per-pathogen microbiological outcome was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment). A total of 4 pathogens in the doripenem group and 2 pathogens in the cefepime group were isolated at baseline from urine culture and were susceptible to the study drug received (see listed in the table below; the numbers in parenthesis next to each pathogen represent the number of participants with the pathogen isolated at baseline in the doripenem and cefepime treatment groups, respectively).|LFU (28 to 42 days after the last dose of study medication therapy)|Microbiological intent-to-treat - Participants of all CITT with at least 1 baseline bacterial pathogen isolated from the pretreatment urine culture, susceptible to both doripenem and cefepime. 6 and 2 participants from doripenem and cefepime, respectively had no susceptible urine pathogens at baseline and were excluded from this set.||Participants|||Number
816688|NCT01110408|Secondary|Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at Test Of Cure (TOC) Visit|The favorable per-pathogen microbiological outcome was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment). A total of 4 pathogens in the doripenem group and 2 pathogens in the cefepime group were isolated at baseline from urine culture and were susceptible to the study drug received (see listed in the table below; the numbers in parenthesis next to each pathogen represent the number of participants with the pathogen isolated at baseline in the doripenem and cefepime treatment groups, respectively).|TOC (7 to 14 days after the last dose of study medication therapy)|Microbiological intent-to-treat - Participants of all CITT with at least 1 baseline bacterial pathogen isolated from the pretreatment urine culture, susceptible to both doripenem and cefepime. 6 and 2 participants from doripenem and cefepime, respectively had no susceptible urine pathogens at baseline and were excluded from this set.||Participants|||Number
816689|NCT01110408|Secondary|Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at End of IV (EIV) Visit|The favorable per-pathogen microbiological outcome was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment).A total of 4 pathogens in the doripenem group and 2 pathogens in the cefepime group were isolated at baseline from urine culture and were susceptible to the study drug received (see listed in the table below; the numbers in parenthesis next to each pathogen represent the number of participants with the pathogen isolated at baseline in the doripenem and cefepime treatment groups, respectively).|EIV (within 24 hours after completion of the last dose of IV study medication therapy)|Microbiological intent-to-treat - Participants of all CITT with at least 1 baseline bacterial pathogen isolated from the pretreatment urine culture, susceptible to both doripenem and cefepime. 6 and 2 participants from doripenem and cefepime, respectively had no susceptible urine pathogens at baseline and were excluded from this set.||Participants|||Number
816690|NCT01110408|Secondary|The Number of Participants With Favorable Per-participant Microbiological Response|Favorable per-participant microbiological response rate was evaluated at the at End of IV (EIV) visit, Test Of Cure (TOC) visit, and Late Follow-Up (LFU) visit. The favorable per-participant microbiological response was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment).|EIV (within 24 hours after completion of the last dose of IV study medication therapy), TOC (7 to 14 days after the last dose of study medication therapy), and LFU (28 to 42 days after the last dose of study medication therapy)|Microbiological intent-to-treat - Participants of all CITT with at least 1 baseline bacterial pathogen isolated from the pretreatment urine culture, susceptible to both doripenem and cefepime. 6 and 2 participants from doripenem and cefepime, respectively had no susceptible urine pathogens at baseline and were excluded from this set.||Participants|||Number
816691|NCT01110408|Secondary|The Number of Participants With Clinical Cure Rate at Late Follow-Up (LFU) Visit|The participants were classified as clinical cure if all pretreatment signs and symptoms of complicated urinary tract infection showed no evidence of recurrence after test of cure.|LFU (28 to 42 days after the last dose of study medication therapy)|Clinical Intent-to-Treat (CITT): All randomized participants who met the minimal disease definition of complicated urinary tract infection regardless if a baseline pathogen was isolated from the pretreatment urine culture.||Participants|||Number
816692|NCT01110408|Secondary|The Number of Participants With Clinical Improvement Rate at End of IV (EIV) Visit|The participants were considered as clinical improved if they had clinical improvement in signs and symptoms from baseline; no fever for at least the 24 hours before discontinuing the IV study drug; and not received nonstudy antibiotics for the treatment of urinary tract infection after IV study drug therapy had begun.|EIV (within 24 hours after completion of the last dose of IV study medication therapy)|Clinical Intent-to-Treat (CITT): All randomized participants who met the minimal disease definition of complicated urinary tract infection regardless if a baseline pathogen was isolated from the pretreatment urine culture.||Participants|||Number
816693|NCT01110408|Primary|The Number of Participants With Clinical Cure Rate at Test Of Cure (TOC) Visit|The participants were classified as cure if they had resolution or clinical improvement in signs and symptoms of complicated urinary tract infection; had no fever; no additional antimicrobial therapy was required for the treatment of the infection; and a clinical response assessment of improvement at End of IV visit.|TOC (7 to 14 days after the last dose of study medication therapy)|Clinical Intent-to-Treat (CITT): All randomized participants who met the minimal disease definition of complicated urinary tract infection regardless if a baseline pathogen was isolated from the pretreatment urine culture.||Participants|||Number
833439|NCT01258049|Secondary|PCT 50 [MITT Population]|Time for parasite counts to fall by 50%|28 days after start of treatment|||hours||Standard Deviation|Mean
816695|NCT01114945|Primary|Percentage of Glottic Opening (POGO) [%]|"POGO score of 100% denotes visualization of the entire glottic opening in linear fashion from the anterior commissure to the posterior cartilages. If none of the glottic opening is seen, then the POGO score is 0%.
View of the glottic opening (0-100%) during the intubation process."|up to 1 minute|||percentage of glottis opening||Standard Deviation|Mean
816696|NCT01114945|Primary|Time to Obtain Glottis Visualization (Seconds)|"It is the time (seconds) following initial insertion of laryngoscope blade to obtain a glottic view.
Start of intubation procedure to Glottic view (the opening between the vocal cords at the upper part of the larynx) visualization comparison between the four devices in patients undergoing bariatric surgery"|up to 1 minute|||Seconds||Standard Deviation|Mean
816697|NCT01114945|Primary|Intubation Time Using a Stop Watch|Evaluate if the time it takes to achieve successful tracheal intubation in patients undergoing bariatric surgery (weight loss surgery) will be reduced using the video-mac, glidescope, and McGrath vs direct laryngoscopy.|up to 3 minutes|"Times following initial insertion of laryngoscope blade:
to obtain glottic view (sec) to placement of tracheal tube (sec) to confirm with CO2 waveform (sec)"||Seconds||Standard Deviation|Mean
816698|NCT01114997|Secondary|Post-anesthesia Care Unit (PACU) Stay||1 day|||Minutes||Standard Deviation|Mean
816699|NCT01114997|Secondary|Patient Satisfaction|Patient satisfaction using a verbal rating scale from 0 to 10 0= Not satisfied 10= Excellent|1 month|||Score on a scale||Standard Deviation|Mean
816700|NCT01114997|Secondary|Return to Normal Activities of Daily Living Using Follow up Questionnaires|Description: return to normal activities of daily living(including dietary intake, bowel and bladder function, physical activities)|1 month|||participants|||Number
816701|NCT01114997|Secondary|Number of Participants With Postoperative Nausea One Day After Surgery|Postoperative nausea using a Verbal Rating Scale Outcomes measured at the first day after surgery|1day|||participants|||Number
816702|NCT01114997|Secondary|Opioid Consumption Obtained From the Recorded Data|Postoperative use of opioid consumption inside hospital (recorded by study staff and data obtained from patient charts)|1 day|Opioid: Hydromorphone||mg||Standard Deviation|Mean
816703|NCT01114997|Primary|Number of Participants With Post Operative Pain One Month After Surgery|"Highest Post Operative pain one month after surgery, using a verbal rating score from 0 (no pain) to 10 (highest level of pain).
Patient received a post-operative follow-up call one month after surgery."|1 month|Experience of pain at home||participants|||Number
816704|NCT01114997|Primary|Post Operative Pain|Outcome had a duration of one day at post-anesthesia care unit (PACU) Postoperative pain measured using a Verbal Rating Scale (VRS) Postoperative pain VRS scores: 0 = none pain to 10 = intolerable pain.|1 day|||Score on a scale||Standard Deviation|Mean
816705|NCT01115101|Secondary|Costs|Evaluation costs between groups|6 month||||||
816706|NCT01115101|Secondary|Mobilisation|Evaluation of time to post surgical mobilization|6 month||||||
816707|NCT01115101|Secondary|Side Effects|Evaluation of side effects|6 month||||||
816708|NCT01115101|Secondary|Subgroups|Secondary Outcome Measures were to identify subgroups in benefit of either therapy.|6 month||||||
816709|NCT01115101|Primary|Difference of Pain Scores on the Visual Analog Scale|"The primary outcome measure was the change in patients assessment of pain after cesarean (CS) from baseline.
For pain assessment a visual analog scale (VAS) was used. Women were asked to quantify pain using an eleven point numerical rating score from 0 to 10, with 0 indicating no pain, and 10 the worst pain.
Single value were calculated (averaged)."|Pain level was evaluated before therapy (2h after CS), 12h, 24h, 32h, 40h, 48 and 72h after CS.|The sample size (intention to treat) was computed to detect a difference in VAS score at 24h of 1.2 (30% reduction) at a power of 80%, a two-sided significance level of 0.05.||VAS score at 24 hours||Standard Deviation|Mean
816710|NCT01115166|Other Pre-specified|Fluid Extravasation|Rate of fluid transfer from the intravascular to the extravascular compartment during two distribution half-times. Graph derived from the hemoglobin change during 20 to 30 minutes after start of cardio pulmonary by-pass.|Two distribution half-times. Approximately 16 minutes.|The study was mainly an observational study, and 10 patients was regarded as a sufficient number to register general changes.||mL/kg/min||Standard Deviation|Median
816711|NCT01115166|Secondary|Intracellular Edema|"Mass balance based on repeated Sodium concentration, fluid volume given, given and excreted Sodium.
A positive value indicating intracellular fluid accumulation and a negative value indicating cell dehydration. This is the change that will occur during the first 30 min after start of cardio pulmonary bypass."|30 minutes after CPB|Mainly observational. 10 patients were regarded to be a sufficient number to se a tendency.||Litre||Standard Deviation|Mean
816712|NCT01115166|Primary|Blood Volume|"volume kinetic technique: During start of cardio pulmonary by-pass a known amount of fluid will expand the blood volume and dilute the hemoglobin.
The hemoglobin variation is used to calculate the blood volume. The last hemoglobin value before CPB and the hemoglobin value directly after start (extrapolated from the following 30 minutes after start) of CPB are used in the calculation.
The value for the blood volume directly prior to CPB will be influenced by intra venous fluids given during early stages of the anesthesia.
To achieve the blood volume prior to anesthesia a hemoglobin value before anesthesia and the last hemoglobin value before CPB are used to correct the blood volume calculation. In this way blood volume prior to anaesthesia can be calculated."|30 minutes after start of CPB|The study was mainly an observational study, and 10 patients was regarded as a sufficient number to register general changes.||Litre||Standard Deviation|Mean
816713|NCT01115452|Secondary|Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 20 Mins Post Treatment on Day 5 Using a VAS|"Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline."|Baseline and 20 mins post treatment on Day 5|Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated||units on a scale||95% Confidence Interval|Mean
818395|NCT01125930|Secondary|Severity of Erythematotelangiectatic Signs: Facial Edema|Severity of erythematotelangiectatic signs include redness (non-transient erythema), telangiectasia, facial edema, and dry skin.|2, 6, 12, 18 weeks|LOCF, Complete-Case ITT Population||participants|||Number
816714|NCT01115452|Secondary|Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 10 Mins Post Treatment on Day 5 Using a VAS|"Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline."|Baseline and 10 mins post treatment on Day 5|Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated||units on a scale||95% Confidence Interval|Mean
816715|NCT01115452|Secondary|Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Immediately Following Treatment on Day 5 Using a VAS in 5% Potassium Nitrate Solution and Water; 2.5% Potassiun Nitrate Solution and Water|"Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline."|Baseline and immediately after treatment on Day 5|Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated||units on a scale||95% Confidence Interval|Mean
816716|NCT01115452|Secondary|Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli 20 Mins Post Treatment on Day 4 Using a VAS|"Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline."|Baseline and 20 mins post treatment on Day 4|Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated||units on a scale||95% Confidence Interval|Mean
816717|NCT01115452|Secondary|Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 10 Mins Post Treatment on Day 4 Using a VAS|"Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline."|Baseline and 10 mins post treatment on Day 4|Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated||units on a scale||95% Confidence Interval|Mean
816718|NCT01115452|Secondary|Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Following Treatment on Day 4 Using a VAS|"Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline."|Baseline and immediately after treatment on Day 4|Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated||units on a scale||95% Confidence Interval|Mean
816719|NCT01115452|Secondary|Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 20 Mins Post Treatment on Day 3 Using a VAS|"Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline."|Baseline and 20 mins post treatment on Day 3|Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated.||units on a scale||95% Confidence Interval|Mean
816720|NCT01115452|Secondary|Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 10 Mins Post Treatment on Day 3 Using a VAS|"Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline."|Baseline and 10 mins post treatment on Day 3|Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated||units on a scale||95% Confidence Interval|Mean
816746|NCT01115582|Primary|Serum and Urine Bile Acids|Concentration of bile acids in serum (S) and urine (U). (abbreviations: chol.=cholenoic; monohydro=monohydroxy; dihydro=monohydro)|At baseline (BL) and after 30 days of treatment (D30)|All patients entered and treated||mmol/L||Standard Deviation|Mean
816747|NCT01115582|Primary|Serum Transaminases|Concentration of serum alanine transaminase (ALT) and aspartate transaminase (AST)|At baseline and after 30 days of treatment|All patients entered and treated||U/L||Standard Deviation|Mean
816721|NCT01115452|Secondary|Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Immediately Following Treatment on Day 3 Using a VAS|"Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline."|Baseline and immediately after treatment on Day 3|Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated||units on a scale||95% Confidence Interval|Mean
816722|NCT01115452|Secondary|Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 20 Mins Post Treatment on Day 2 Using a VAS|"Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline."|Baseline and 20 mins post treatment on Day 2|Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated||units on a scale||95% Confidence Interval|Mean
816723|NCT01115452|Secondary|Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 10 Mins Post Treatment on Day 2 Using a VAS|"Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline."|Baseline and 10 mins post treatment on Day 2|Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated||units on a scale||95% Confidence Interval|Mean
816724|NCT01115452|Secondary|Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Following Treatment on Day 2 Using a VAS|"Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline."|Baseline and immediately after treatment on Day 2|Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated||units on a scale||95% Confidence Interval|Mean
816725|NCT01115452|Secondary|Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 20 Mins Post Treatment on Day 1 Using a VAS.|"Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline."|Baseline and 20 mins post treatment on Day 1|Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated||units on a scale||95% Confidence Interval|Mean
816726|NCT01115452|Secondary|Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 10 Mins Post Treatment on Day 1 Using a VAS|"Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline."|Baseline and 10 mins post treatment on Day 1|Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated||units on a scale||95% Confidence Interval|Mean
816727|NCT01115452|Secondary|Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Immediately Following Treatment on Day 1 Using a VAS|"Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline."|Baseline and immediately after treatment on Day 1|Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated||units on a scale||95% Confidence Interval|Mean
816748|NCT01115660|Secondary|Follow up Appointment With MD|Follow up appointment with primary care provider since stroke|3 months|Patients who were contacted at 3 months||participants|||Number
816749|NCT01115660|Primary|Feasibility of Intervention (Ability to Reach Patients at 3 Months)|Number of patients contacted at 3 months|3 months|All eligible patients who also were available at 3 months for post-intervention follow-up call.||number of patients contacted|||Number
833440|NCT01258049|Secondary|PCT 90 [MITT Population]|Time for parasite counts to fall by 90%|28 days after start of treatment|||hours||Standard Deviation|Mean
816728|NCT01115452|Primary|Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Immediately Following Treatment on Day 5 Using a Visual Analog Scale (VAS) in 5% Potassium Nitrate Solution and 2.5% Potassium Nitrate Solution|"Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline."|Baseline and immediately after treatment on Day 5|Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated||units on a scale||95% Confidence Interval|Mean
816729|NCT01115491|Secondary|Percentage of Participants Achieving an Overall Response of Complete Response (CR) or Partial Response (PR)|Overall response was defined as the percentage of participants who obtained CR or PR using adapted MacDonald criteria. CR: disappearance of all index and non-index lesions, confirmed no less than 4 weeks after assessment, no evidence of disease progression; corticosteroid dosage at or below 20 mg hydrocortisone daily; no neurological changes or an improvement as compared to last disease assessment. PR was defined as: Fifty percent or greater decrease in the sum of products of the larger diameter and the larger perpendicular diameter of all index lesions confirmed no less than 4 weeks after assessment, no evidence of disease progression and the absence of progressive, or non-evaluable disease status for non-index legions; unchanged, or decreased corticosteroid dose as compared to the last disease assessment; no neurological changes or an improvement as compared to the neurological examination at last disease assessment.|BL, every 28 days, until progression, death or end-of-study, an average of 32 weeks|ITT population||percentage of participants|||Number
816730|NCT01115491|Primary|PFS: Probability of Remaining Progression Free at 24 Weeks After Beginning the Study||BL, 24 weeks (after 6th cycle)|ITT population||survival probability|||Number
816731|NCT01115491|Secondary|Overall Survival - Time to Event|Overall survival was defined as the time transpired (in weeks) between the date of the participant's inclusion in the trial until the date of his/her death by any cause. Participants that were alive at the time the analysis was performed were censored on the date of last contact. Median overall survival was estimated using the Kaplan-Meier method.|BL, every 28 days, until death or end-of-study, an average of 32 weeks|ITT population||weeks||95% Confidence Interval|Median
816732|NCT01115491|Secondary|Overall Survival - Percentage of Participants With an Event|Overall survival was defined as the time transpired (in weeks) between the date of the participant's inclusion in the trial until the date of his/her death by any cause. Participants that were alive at the time the analysis was performed were censored on the date of last contact.|BL, every 28 days, until death or end-of-study, an average of 32 weeks|ITT population||percentage of participants|||Number
816733|NCT01115491|Primary|PFS - Time to Event|PFS was defined as the time, in weeks, from the date of inclusion in the study to the date of the first documentation of disease progression or death of the participant due to any cause. Participants that did not have an event at the time the analysis was performed were censored at the date of last contact. Participants that began a treatment other than those planned in this study (bevacizumab or temozolomide) were censored on the start date of the new treatment. PFS was estimated using the Kaplan-Meier method.|BL, every 28 days, until progression, death or end-of-study, an average of 32 weeks|ITT population||weeks||95% Confidence Interval|Median
816734|NCT01115491|Primary|Progression-Free Survival (PFS) - Percentage of Participants With an Event|PFS was defined as the time, in weeks, from the date of inclusion in the study to the date of the first documentation of disease progression or death of the participant due to any cause. Participants that did not have an event at the time the analysis was performed were censored at the date of last contact. Participants that began a treatment other than those planned in this study (bevacizumab or temozolomide) were censored on the start date of the new treatment.|Baseline (BL), every 28 days, until progression, death or end-of-study, an average of 32 weeks|ITT population||percentage of participants|||Number
816735|NCT01115517|Secondary|Number of Participants Who Had Related Serious Adverse Events From the Time of Treatment to 1 Year||1 year|||participants|||Number
816736|NCT01115517|Secondary|Number of Participants Who Had Complications From the Time of Treatment to Recurrence||1 year|||participants|||Number
816737|NCT01115517|Primary|Number of Participants Who Had Recurrence of Pterygia up to 1 Year||1 year|||participants|||Number
816738|NCT01115556|Secondary|Mean Change in Visual Acuity (VA) From Baseline at Month 12|"Mean change in Visual Acuity (VA) from Baseline at Month 12
Mean change in central foveal thickness (RPE to ILM) as measured by SD-OCT (Spectralis HRA + OCT (Heidelberg Engineering, Heidelberg, Germany) at Months 6 and 12
Mean change in leakage as determined by FA at Months 6 and 12
Mean number of ranibizumab injections at Months 6 and 12
Mean time to first re-treatment following the initial 3 monthly loading doses
Mean duration of fluid-free interval
Safety and tolerability of 2.0mg using the incidence and severity of adverse events"|one year|||ETDRS Letters||Standard Deviation|Mean
816739|NCT01115556|Primary|Mean Change in Visual Acuity (VA) From Baseline at Month 6||Baseline and 6 months|||ETDRS Letters||Standard Deviation|Mean
816740|NCT01115569|Secondary|Maintenance of Efficacy|Clinic Numeric Rating Scale (NRS), Brief Pain Inventory (BPI), Oswestry Disability Index, Hospital Anxiety and Depression Scale, Rescue Doses and Subject Global of Medication|1 year||||||
816741|NCT01115569|Primary|Mean Change in Average Daily Pain|Numeric Rating Scale (NRS) for Pain (0-10; where 0 = no pain, 10 = worst pain imaginable) recorded up to 54 weeks, starting at screening through end of study. Lower number equals better outcome.|1 year|The number of participants for analysis was determined by the safety population. Numeric Rating Scale (NRS) for Pain assessment was used. Measure is mean change in average daily pain intensity. Total number of participants providing end of study pain intensity score = 391.||units on a scale||Standard Deviation|Mean
816742|NCT01115582|Secondary|Total Bilirubin|Concentration of total bilirubin in serum|At baseline and after 30 days of treatment|All patients entered and treated||mg/dL||Standard Deviation|Mean
816743|NCT01115582|Secondary|Physical Examination|Total number of patients with abnormal findings from general physical examination|At baseline (BL) and after 30 days of treatment (D30)|All patients entered and treated||participants|||Number
816750|NCT01115673|Secondary|Patient Global Evaluation|Patient Assessment of the Pain Medication – Number of Subjects rating the medication they received as a pain reliever on a score of 0-4, where 0=poor, 1=fair, 2=good, 3=very good, 4=excellent|6 Hours|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||Units on a scale||Standard Error|Least Squares Mean
816751|NCT01115673|Secondary|Percentage of Subjects With >50% of the Maximum Possible TOTPAR6 Score|Percentage of Subjects with >50% of the Maximum Possible TOTPAR6 Score - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 600 so >50% is >300 out of 600|6 Hours|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||Percentage of Participants|||Number
816752|NCT01115673|Secondary|Rescue Rates Through Six Hours|Percentage of subjects using rescue medication.|through 6 Hours|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||Percentage of Participants|||Number
816753|NCT01115673|Secondary|Rescue Rates Through Four Hours|Percentage of subjects using rescue medication.|through 4 Hours|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||Percentage of Participants|||Number
816754|NCT01115673|Secondary|Duration of Analgesia – Time to Rescue|Minutes until rescue medication was given.|within 6 Hours|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||Minutes||Full Range|Median
816755|NCT01115673|Secondary|Time to Confirmed Perceptible Pain Relief|Minutes until confirmed perceptible pain relief was achieved. A stopwatch was provided to the subject after ingestion of the study medication. The subject was instructed to stop the stopwatch when they first began to feel any pain relieving effect whatsoever of the drug, that was when they first felt any pain relief. It did not necessarily mean they felt completely better, although they might have, but when they first felt any difference in the pain.|within 6 Hours|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||Minutes||Full Range|Median
816756|NCT01115673|Secondary|Time to Meaningful Pain Relief|Minutes until meaningful pain relief was achieved. A stopwatch was provided to the subject after ingestion of the study medication. The subject was instructed to stop the stopwatch when the relief from the starting pain was meaningful to them.|within 6 Hours|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||Minutes||Full Range|Median
816757|NCT01115673|Secondary|Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 360 Minutes|Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief|360 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
816758|NCT01115673|Secondary|Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 300 Minutes|Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief|300 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
816759|NCT01115673|Secondary|Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 240 Minutes|Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief|240 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
816760|NCT01115673|Secondary|Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 180 Minutes|Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief|180 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
816761|NCT01115673|Secondary|Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 120 Minutes|Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief|120 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
817911|NCT01121666|Secondary|Number and Size of Follicles ≥ 12 mm at Day 8 of Stimulation|The number and size of follicles 12 mm or over in diameter at day 8 of stimulation were evaluated as secondary end-point.|Day 8 of stimulation|All participants were analyzed.||Number of follicles||Standard Deviation|Mean
816762|NCT01115673|Secondary|Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 90 Minutes|Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief|90 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
816763|NCT01115673|Secondary|Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 75 Minutes|Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief|75 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
816764|NCT01115673|Secondary|Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 60 Minutes|Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief|60 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
816765|NCT01115673|Secondary|Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 45 Minutes|Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief|45 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
816766|NCT01115673|Secondary|Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 30 Minutes|Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief|30 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
816767|NCT01115673|Secondary|Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 15 Minutes|Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief|15 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
816768|NCT01115673|Secondary|Pain Relief (PAR) Scores at 360 Minutes|Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100|360 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
816769|NCT01115673|Secondary|Pain Relief (PAR) Scores at 300 Minutes|Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100|300 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
816770|NCT01115673|Secondary|Pain Relief (PAR) Scores at 240 Minutes|Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100|240 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
816771|NCT01115673|Secondary|Pain Relief (PAR) Scores at 180 Minutes|Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100|180 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
816772|NCT01115673|Secondary|Pain Relief (PAR) Scores at 120 Minutes|Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100|120 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
816773|NCT01115673|Secondary|Pain Relief (PAR) Scores at 90 Minutes|Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100|90 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
816774|NCT01115673|Secondary|Pain Relief (PAR) Scores at 75 Minutes|Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100|75 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
816775|NCT01115673|Secondary|Pain Relief (PAR) Scores at 60 Minutes|Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100|60 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
816776|NCT01115673|Secondary|Pain Relief (PAR) Scores at 45 Minutes|Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100|45 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
816777|NCT01115673|Secondary|Pain Relief (PAR) Scores at 30 Minutes|Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100|30 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
816778|NCT01115673|Secondary|Pain Relief (PAR) Scores at 15 Minutes|Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100|15 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
816779|NCT01115673|Secondary|Pain Intensity Difference (PID) at 360 Minutes|Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.|360 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
816780|NCT01115673|Secondary|Pain Intensity Difference (PID) at 300 Minutes|Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.|300 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, and did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
816781|NCT01115673|Secondary|Pain Intensity Difference (PID) at 240 Minutes|Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.|240 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
816782|NCT01115673|Secondary|Pain Intensity Difference (PID) at 180 Minutes|Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.|180 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
816783|NCT01115673|Secondary|Pain Intensity Difference (PID) at 120 Minutes|Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.|120 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, and did not vomit within 60 minutes after dosing, had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
816784|NCT01115673|Secondary|Pain Intensity Difference (PID) at 90 Minutes|Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.|90 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
816785|NCT01115673|Secondary|Pain Intensity Difference (PID) at 75 Minutes|Pain Intensity Difference (PID) from Baseline at Each Assessment Time Point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.|75 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
816786|NCT01115673|Secondary|Pain Intensity Difference (PID) at 60 Minutes|Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.|60 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
816787|NCT01115673|Secondary|Pain Intensity Difference (PID) at 45 Minutes|Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.|45 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
816788|NCT01115673|Secondary|Pain Intensity Difference (PID) at 30 Minutes|Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.|30 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
816789|NCT01115673|Secondary|Pain Intensity Difference (PID) at 15 Minutes|Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.|15 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
816790|NCT01115673|Secondary|Sum of Pain Relief Scores Over Six Hours (TOTPAR6)|Weighted Sum of the Pain Relief Scores Over Six Hours (TOTPAR6) - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief. The total possible minimum value is 0 (worst) and the total possible maximum value is 600 (best). The weights used in the calculation of weighted sums were equal to the elapsed time (hour) between the time point of interest and the preceding time point.|6 Hours|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
816791|NCT01115673|Secondary|Sum of Pain Intensity Difference Over Six Hours (SPID6)|Weighted Sum of the Pain Intensity Difference from Baseline Over Six Hours (SPID6) - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain. The total possible minimum value is -300 (worst) and the total possible maximum value is 600 (best). The weights used in the calculation of weighted sums were equal to the elapsed time (hour) between the time point of interest and the preceding time point.|6 Hours|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
816792|NCT01115673|Primary|Overall Analgesic Efficacy – Sum of Pain Intensity Difference and Pain Relief Scores Over Six Hours (SPRID6)|Weighted Sum of Pain Intensity Difference and Pain Relief Scores Over Six Hours (SPRID6) - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief. For SPRID6, the total possible minimum value is -300 (worst) and the total possible maximum value is 1200 (best). The weights used in the calculation of weighted sums were equal to the elapsed time (hour) between the time point of interest and the preceding time point.|6 Hours|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
816793|NCT01115699|Secondary|Change in Quick Inventory of Depressive Symptoms - Clinician Rating 16 Item (QIDS-C16)|"The QIDS-C16 measures 16 factors across 9 different criterion domains for major depression. Each of the four possible answers to each quiz is given an ascending numerical value from 0 to 3, and the total test score is the sum of the following:the highest number from questions 1-4 + the number from question 5 + the highest number from questions 6-9 + the total of each question from 10-14 + the highest number from questions 15-16.
Screening test scoring ranges:
0-5, No Depression Likely
6-10, Possibly Mildly Depressed
11-15, Moderate Depression
16-20, Severe Depression
21 or Over, Very Severe Depression"|baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, and 6 weeks|This study was stopped early due to funding constraints and recruitment was slower than was expected.|||||
817944|NCT01123941|Primary|Number of Subjects Reporting Serious Adverse Events (SAEs)||During the 6-month period after vaccination|||participants|||Number
817945|NCT01123941|Primary|Number of Subjects Reporting Adverse Events||During the 28-day period after vaccination|||participants|||Number
816794|NCT01115699|Primary|Change in Hamilton Rating Scale for Depression (HRS-D17)|The HRS-D17 questionnaire has 17 items. Each item on the questionnaire is scored on a 3 or 5 point scale, depending on the item. A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression.|baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, and 6 weeks|This study was stopped early due to funding constraints and recruitment was slower than was expected.|||||
816795|NCT01115738|Secondary|P2Y12 Reaction Units (PRU) at 6 Hours Post-Prasugrel Loading Dose (LD) by Cytochrome P450 2C19 (CYP2C19)-Predicted Functional Groups - Extensive Metabolizers (EM) and Reduced Metabolizers (RM)|CYP2C19 is a drug metabolizing enzyme. CYP2C19 Extensive metabolizers (EM) are individuals with two fully active / normal function CYP2C19 alleles (*1/*1, *1/*17). CYP2C19 Reduced metabolizers (RM) are individuals with at least one reduced-function CYP2C19 allele (*2/*2, *1/*2). Least Squares (LS) Mean values were controlled for CYP2C19 genetic group.|6 hours after prasugrel loading dose|All randomized participants who received prasugrel LD and had PRU measurements 6 hours after prasugrel LD and provided a DNA sample.||PRU||Standard Error|Least Squares Mean
816796|NCT01115738|Secondary|P2Y12 Reaction Units (PRU) of Clopidogrel Treated Participants at Baseline by Cytochrome P450 2C19 (CYP2C19)-Predicted Functional Groups - CYP2C19 Extensive Metabolizers (EM) and Reduced Metabolizers (RM)|CYP2C19 is a drug metabolizing enzyme. CYP2C19 Extensive metabolizers (EM) are individuals with two fully active / normal function CYP2C19 alleles (*1/*1, *1/*17). CYP2C19 Reduced metabolizers (RM) are individuals with at least one reduced-function CYP2C19 allele (*2/*2, *1/*2). Least Squares (LS) Mean values were controlled for CYP2C19 genetic group.|Baseline|All randomized participants who were treated with Clopidogrel and had PRU measurement at Baseline and provided a DNA sample.||PRU||Standard Error|Least Squares Mean
816797|NCT01115738|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs)|TEAE is a worsening or new occurrence of adverse event (AE) during treatment compared to baseline. A summary of serious adverse events (SAE) and other nonserious AE are located in the Reported Adverse Events section.|Baseline through 72 hours after prasugrel loading dose|Participants who received any treatment.||participants|||Number
816798|NCT01115738|Secondary|Percentage of Poor Responders|Poor responders are those who had P2Y12 Reaction Units (PRU)≥ 240.|Baseline and 2 and 6 and 24 and 72 hours after loading dose|All randomized participants who received prasugrel loading dose (LD) and had at least one evaluable PRU measurement after prasugrel LD.||percentage of participants|||Number
816799|NCT01115738|Secondary|Percentage of Inhibition of Platelet Aggregation|Adenosine Diphosphate (ADP)-induced P2Y12 receptor mediated platelet aggregation serves as a biomarker of platelet function. It is measured in P2Y12 Reaction Units (PRU) with lower PRU reflecting stronger inhibition of P2Y12 and reduced platelet aggregation. The internal BASE standard is an independent measurement and serves as an estimate of the participant’s baseline platelet aggregation independent of P2Y12 receptor inhibition. Percent Inhibition of Platelet Aggregation=(1-[PRU/BASE) x 100%, high numbers represent increased platelet inhibition. Least Squares (LS) Mean values were controlled for treatment, visit, treatment and visit interaction, and country.|Baseline and 2 and 6 and 24 and 72 hours after loading dose|All randomized participants who received prasugrel loading dose (LD) and had at least one evaluable PRU measurement after prasugrel LD.||percentage of inhibition||Standard Error|Least Squares Mean
816800|NCT01115738|Secondary|Mean Change From Baseline to 72 Hours in Laboratory Measurements - Hemoglobin||Baseline, 72 hours|All randomized participants who received prasugrel loading dose (LD) and had a Hemoglobin measurement 72 hours after LD.||gram per deciliter (g/dL)||Standard Deviation|Mean
816801|NCT01115738|Secondary|Mean Change From Baseline to 72 Hours in Laboratory Measurements - Hematocrit||Baseline, 72 hours|All randomized participants who received prasugrel loading dose (LD) and had a Hematocrit measurement 72 hours after LD.||proportion of 1.0||Standard Deviation|Mean
816802|NCT01115738|Secondary|Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-Mediated Platelet Aggregation at Baseline, 2, 24 and 72 Hours After Prasugrel Loading Dose (LD)|ADP-induced P2Y12 receptor mediated platelet aggregation serves as a biomarker of platelet function. It is measured in P2Y12 Reaction Units (PRU) with lower PRU reflecting stronger inhibition of P2Y12 and reduced platelet aggregation. Least Squares (LS) Mean values were controlled for treatment, visit, treatment and visit interaction, and country.|Baseline and 2 hours and 24 hours and 72 hours after prasugrel loading dose|All randomized participants who received prasugrel LD and had at least one evaluable PRU measurement after prasugrel LD.||PRU||Standard Error|Least Squares Mean
816803|NCT01115738|Primary|Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-Mediated Platelet Aggregation 6 Hours After Prasugrel Loading Dose (LD)|ADP-induced P2Y12 receptor mediated platelet aggregation serves as a biomarker of platelet function. It is measured in P2Y12 Reaction Units (PRU) with lower PRU reflecting stronger inhibition of P2Y12 and reduced platelet aggregation. Least Squares (LS) Mean values were controlled for treatment, visit, treatment and visit interaction, and country.|6 hours after prasugrel loading dose|All randomized participants who received the prasugrel LD and had at least one evaluable PRU measurement after LD.||PRU||Standard Error|Least Squares Mean
816804|NCT01115855|Secondary|Change From Baseline in Specific Activity Scale (SAS) Score at Week 4, Months 2, 3, 4, 5, 9, 13, 17 21, 25, 29, 33, 37, 42, 48 and Final Visit|Specific activity scale was estimated by pre-specified questionnaire (for different activities) to assess the exercise capability of the participants. Answers provided by participants were transformed in terms of number of metabolic equivalents (METs).1 MET was defined as the amount of oxygen consumed while sitting at rest and is equal to 3.5 ml oxygen per kg body weight* minute. Scale ranged from 1 (less than (<) 2 METs) = lowest level of exercise tolerance to 6 (>=8METs) = highest level of tolerance and higher score indicated more tolerance.|Baseline, Week 4, Months 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48, Final Visit (up to Month 48)|Full analysis set included all randomized participants. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||metabolic equivalents (METs)||Standard Deviation|Mean
816817|NCT01115855|Secondary|Number of Participants With First Occurrence of Cardiovascular (CV) Hospitalization|CV hospitalization, which was defined as any hospitalization due to CV events including HF, myocardial infarction, arrhythmia, angina pectoris. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.|Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)|Full analysis set included all randomized participants.||participants|||Number
817946|NCT01123941|Secondary|Anti-Vi ELISA Geometric Mean Concentration (GMC)||At 28 days after vaccination|||ELISA Units/mL||95% Confidence Interval|Geometric Mean
816805|NCT01115855|Secondary|Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Weeks 1, 4, Months 2, 3, 4, 5, 9, 13, 17 21, 25, 29, 33, 37, 42, 48 and Final Visit|NYHA: classified as ‘class I’ (participants with cardiac disease but without resulting limitations of physical activity), ‘class II’ (participants with cardiac disease resulting in slight limitation of physical activity), ‘class III’ (participants with cardiac disease resulting in marked limitation of physical activity), ‘class IV’ (participants with cardiac disease resulting in inability to carry on any physical activity without discomfort). Participants with change from baseline were classified as ‘improved' (positive change), ‘no change’ or ‘worsened' (negative change).|Baseline, Weeks 1, 4, Months 2, 3, 4, 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48 and Final Visit (up to Month 48)|Full analysis set included all randomized participants. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||participants|||Number
816806|NCT01115855|Secondary|Change From Baseline in Urine Albumin-to-Creatinine Ratio at Months 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48 and Final Visit||Baseline, Months 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48, Final Visit (up to Month 48)|Full analysis set included all randomized participants. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||microgram per gram creatinine (mg/gCr)||Standard Deviation|Mean
816807|NCT01115855|Secondary|Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Months 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48 and Final Visit|LVEF was calculated based on end-diastolic volume measured by two-dimensional echocardiography.|Baseline, Months 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48, Final Visit (up to Month 48)|Full analysis set included all randomized participants. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||percentage of LVEF||Standard Deviation|Mean
816808|NCT01115855|Secondary|Change From Baseline in Plasma Concentration of Serum N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP) at Months 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48 and Final Visit||Baseline, Months 5, 9, 13, 17, 21 ,25, 29, 33, 37, 42, 48 and Final Visit (up to Month 48)|Full analysis set included all randomized participants. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||pg/mL||Standard Deviation|Mean
816809|NCT01115855|Secondary|Change From Baseline in Plasma Concentration of Brain Natriuretic Peptide at Months 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48 and Final Visit||Baseline, Months 5,9,13,17,21,25,29,33,37,42,48, Final Visit (up to Month 48)|Full analysis set included all randomized participants. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||picogram/milliliter (pg/ml)||Standard Deviation|Mean
816810|NCT01115855|Secondary|Number of Participants With First Occurrence of Hospitalization for Hyperkalemia|Hospitalization due to hyperkalemia (as per physician’s decision) was defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to hyperkalemia as the primary reason for hospitalization. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.|Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)|Full analysis set included all randomized participants.||participants|||Number
816811|NCT01115855|Secondary|Number of Participants With First Occurrence of Hospitalisation Due to Worsening Renal Function|Hospitalization due to worsening renal function (as per physician’s decision) was defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to worsening renal function as the primary reason for hospitalization. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.|Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)|Full analysis set included all randomized participants.||participants|||Number
816812|NCT01115855|Secondary|Number of Participants With First Occurrence of New Onset Diabetes Mellitus|New onset diabetes mellitus was defined as the diagnosis of diabetes mellitus in a participant after randomization. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.|Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)|Full analysis set included all randomized participants.||participants|||Number
816813|NCT01115855|Secondary|Number of Participants With First Occurrence of New Onset Atrial Fibrillation/Flutter|New onset of atrial fibrillation or flutter was defined as the diagnosis of atrial fibrillation or flutter in a participant after randomization. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.|Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)|Full analysis set included all randomized participants.||participants|||Number
816814|NCT01115855|Secondary|Number of Participants With First Occurrence of Fatal/Non-Fatal Myocardial Infarction (MI)|Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.|Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)|Full analysis set included all randomized participants.||participants|||Number
816815|NCT01115855|Secondary|Number of Participants With First Occurrence of Fatal/Non-Fatal Stroke|Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.|Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)|Full analysis set included all randomized participants.||participants|||Number
816816|NCT01115855|Secondary|Number of Participants With First Occurrence of Addition/Increase of Heart Failure (HF) Medication Due to Heart Failure (HF) Worsening|Addition/ increase of HF medications was defined as administration of new HF medication or increase of 50 percent or more in dose of HF medication for >= 3 days. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.|Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)|Full analysis set included all randomized participants.||participants|||Number
816890|NCT01116232|Secondary|Incidence of Infections Including Cytomegalovirus, Epstein-Barr Virus Reactivation, and Post-transplant Lymphoproliferative Disorder||At one year||||||
816891|NCT01116232|Secondary|Incidence of Chronic GVHD||Within two years after transplant||||||
816818|NCT01115855|Secondary|Number of Participants With First Occurrence of Heart Failure (HF) Mortality or Heart Failure (HF) Hospitalization|HF mortality was defined as any death due to HF. Hospitalization due to HF was defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.|Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)|Full analysis set included all randomized participants.||participants|||Number
816819|NCT01115855|Secondary|Number of Participants With First Occurrence of All-cause Mortality or All-cause Hospitalization|All cause hospitalization included all hospitalizations as CV hospitalization, which was defined as any hospitalization due to CV events including HF, myocardial infarction, arrhythmia, angina pectoris and non-CV hospitalizations which was defined as any hospitalization due to non-CV events including renal dysfunction, hyperkalaemia, malignant tumor and pulmonary disease. All-cause mortality was defined as any CV mortality, Non-CV mortality, including malignant tumor, pulmonary disease and trauma.CV mortality was defined as death due to HF, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident, other CV cause (such as aneurysm or pulmonary embolism). Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.|Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)|Full analysis set included all randomized participants.||participants|||Number
816820|NCT01115855|Secondary|Number of Participants With First Occurrence of Hospitalization Due to Heart Failure (HF)|Hospitalization due to HF was defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.|Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)|Full analysis set included all randomized participants.||participants|||Number
816821|NCT01115855|Secondary|Number of Participants With First Occurrence of All-cause Hospitalization|All cause hospitalization included all hospitalizations as CV hospitalization, which was defined as any hospitalization due to CV events including HF, myocardial infarction, arrhythmia, angina pectoris and non-CV hospitalizations which was defined as any hospitalization due to non-CV events including renal dysfunction, hyperkalaemia, malignant tumor and pulmonary disease. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.|Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)|Full analysis set included all randomized participants.||participants|||Number
816822|NCT01115855|Secondary|Number of Participants With With First Occurrence of Cardiovascular Mortality|CV mortality was defined as death due to HF, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident, other CV cause (such as aneurysm or pulmonary embolism). Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.|Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)|Full analysis set included all randomized participants.||participants|||Number
816823|NCT01115855|Secondary|Number of Participants With With First Occurrence of All-Cause Mortality|All-cause mortality was defined as any CV mortality, Non-CV mortality, including malignant tumor, pulmonary disease and trauma.CV mortality was defined as death due to HF, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident, other CV cause (such as aneurysm or pulmonary embolism). Mortality during treatment, within 30 days of treatment discontinuation and after 30 days of discontinuation was reported. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.|Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)|Full analysis set included all randomized participants.||participants|||Number
816824|NCT01115855|Secondary|Number of Participants With First Occurrence of Cardiovascular (CV) Mortality, Hospitalization Due to Heart Failure (HF), or Addition/Increase of Heart Failure (HF) Medication|CV mortality was defined as any death due to HF, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident, other CV cause (such as aneurysm or pulmonary embolism). Hospitalization due to HF was defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF. Addition/ increase of HF medications was defined as administration of new HF medication or increase of 50 percentage (%) or more in dose of HF medication for >= 3 days. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.|Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)|Full analysis set included all randomized participants.||participants|||Number
816825|NCT01115855|Primary|Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF)|CV mortality was defined as any death due to HF, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident, other CV cause (such as aneurysm or pulmonary embolism). Hospitalization due to HF was defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.|Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)|Full analysis set included all randomized participants.||participants|||Number
816826|NCT01115933|Secondary|Overall Stent Thrombosis|Stent thrombosis was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of ST; probable: unexplained death ≤30 days or target vessel MI without angiographic information; and possible: unexplained death >30 days after stent placement.”|0 - 298 days|FAS population||percentage of participants|||Number
816827|NCT01115933|Secondary|Late Stent Thrombosis|Stent thrombosis was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of ST; probable: unexplained death ≤30 days or target vessel MI without angiographic information; and possible: unexplained death >30 days after stent placement.”|31 - 298 days|FAS population||percentage of participants|||Number
816892|NCT01116232|Primary|Safety Assessment||During the first six months post transplant||||||
816828|NCT01115933|Secondary|Acute/Subacute Stent Thrombosis|Stent thrombosis was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of ST; probable: unexplained death ≤30 days or target vessel MI without angiographic information; and possible: unexplained death >30 days after stent placement.”|0-30 days|FAS population||percentage of participants|||Number
816829|NCT01115933|Secondary|Subacute Stent Thrombosis|Stent thrombosis was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of ST; probable: unexplained death ≤30 days or target vessel MI without angiographic information; and possible: unexplained death >30 days after stent placement.”|1-30 days|FAS population||percentage of participants|||Number
816830|NCT01115933|Secondary|Acute Stent Thrombosis|Stent thrombosis (ST) was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of ST; probable: unexplained death ≤30 days or target vessel MI without angiographic information; and possible: unexplained death >30 days after stent placement.”|<24 hours|FAS population||percentage of participants|||Number
816831|NCT01115933|Secondary|All Coronary Revascularization||9 months|FAS population||percentage of participants|||Number
816832|NCT01115933|Secondary|All Coronary Revascularization||1 months|Full Analysis Set (FAS population)||percentage of participants|||Number
816833|NCT01115933|Secondary|Composite Endpoint of Cardiac Death, All MI and CI-TLR (MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial-infarction, and clinically-indicated target lesion revascularization (CI-TLR).|9 months|FAS population||percentage of participants|||Number
816834|NCT01115933|Secondary|Composite Endpoint of Cardiac Death/All MI/CI-TLR (MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial-infarction, and clinically-indicated target lesion revascularization (CI-TLR).|1 month|Full Analysis Set (FAS population)||percentage of participants|||Number
816835|NCT01115933|Secondary|Composite Endpoint of Cardiac Death/TV-MI/CI-TLR (TLF)|Target lesion failure (TLF) is defined as a composite of cardiac death, target-vessel related myocardial infarction (TV-MI) and clinically-indicated target lesion revascularization (CI-TLR).|1 month|FAS population||percentage of participants|||Number
816836|NCT01115933|Secondary|Composite Endpoint of All Death/All MI/All Revascularization (DMR)|DMR event (all death, all MI (per protocol or per ARC), all revascularization, respectively).|9 months|Full Analysis Set (FAS population)||percentage of participants|||Number
816837|NCT01115933|Secondary|Composite Endpoint of All Death/All MI/All Revascularization (DMR)|DMR event (all death, all MI (per protocol or per ARC), all revascularization, respectively).|1 month|Full Analysis Set (FAS population)||percentage of participants|||Number
816838|NCT01115933|Secondary|Composite Endpoint of Cardiac Death/All MI||9 months|Full Analysis Set (FAS population)||percentage of participants|||Number
816839|NCT01115933|Secondary|Composite Endpoint of Cardiac Death/All MI||1 month|Full Analysis Set (FAS population)||percentage of participants|||Number
816840|NCT01115933|Secondary|Target Vessel Revascularization (TVR, Per ARC Definition) Not Clinically-indicated TVR (NCI-TVR)|TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.|9 months|Full Analysis Set (FAS population)||percentage of participants|||Number
816841|NCT01115933|Secondary|Target Vessel Revascularization (TVR, Per ARC Definition) Not Clinically-indicated TVR (NCI-TVR)|TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.|1 month|Full Analysis Set (FAS population)||percentage of participants|||Number
816842|NCT01115933|Secondary|Target Vessel Revascularization (TVR, Per ARC Definition) Clinically-indicated TVR (CI-TVR)|TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.|9 months|Full Analysis Set (FAS population)||percentage of participants|||Number
816843|NCT01115933|Secondary|Target Vessel Revascularization (TVR, Per ARC Definition) Clinically-indicated TVR (CI-TVR)|TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.|1 month|Full analysis set (FAS) population||percentage of participants|||Number
816844|NCT01115933|Secondary|Target Vessel Revascularization (TVR, Per ARC Definition)|TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.|9 months|FAS population||percentage of participants|||Number
816845|NCT01115933|Secondary|Target Vessel Revascularization (TVR, Per ARC Definition)|TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.|1 month|FAS Population||percentage of participants|||Number
816846|NCT01115933|Secondary|Target Lesion Revascularization (TLR, Per ARC Definition) Not Clinically-indicated TLR (NCI-TLR)|Any revascularization for in-segment restenosis will be considered TLR. “Segment” is defined as the area within the margins of the stent and 5 mm proximal and 5 mm distal to the stent. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.|9 months|FAS population||percentage of participants|||Number
816847|NCT01115933|Secondary|Target Lesion Revascularization (TLR, Per ARC Definition) Not Clinically-indicated TLR (NCI-TLR)|Any revascularization for in-segment restenosis will be considered TLR. “Segment” is defined as the area within the margins of the stent and 5 mm proximal and 5 mm distal to the stent. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.|1 month|Full analysis set (FAS) population||percentage of participants|||Number
816848|NCT01115933|Secondary|Target Lesion Revascularization (TLR, Per ARC Definition) Clinically-indicated TLR (CI-TLR)|Any revascularization for in-segment restenosis will be considered TLR. “Segment” is defined as the area within the margins of the stent and 5 mm proximal and 5 mm distal to the stent. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.|9 months|Full Analysis Set (FAS population)||percentage of participants|||Number
816849|NCT01115933|Secondary|Target Lesion Revascularization (TLR, Per ARC Definition) Clinically-indicated TLR (CI-TLR)|Any revascularization for in-segment restenosis will be considered TLR. “Segment” is defined as the area within the margins of the stent and 5 mm proximal and 5 mm distal to the stent. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.|1 month|Full analysis set (FAS) population||percentage of participants|||Number
816850|NCT01115933|Secondary|Target Lesion Revascularization (TLR, Per ARC Definition)|Any revascularization for in-segment restenosis will be considered TLR. “Segment” is defined as the area within the margins of the stent and 5 mm proximal and 5 mm distal to the stent. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.|9 months|FAS Population||percentage of participants|||Number
816851|NCT01115933|Secondary|Target Lesion Revascularization (TLR, Per ARC Definition)|Any revascularization for in-segment restenosis will be considered TLR.“Segment” is defined as the area within the margins of the stent and 5 mm proximal and 5 mm distal to the stent. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.|1 month|Full analysis set (FAS) population||percentage of participants|||Number
816852|NCT01115933|Secondary|Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions) Not Attributable to Target Vessel (NTV-MI)|"Definitions in SPIRIT III Study:
Q wave MI: Development of new, pathological Q wave on the ECG Non-Q wave MI: Elevation of CK levels to >=two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves Per ARC definition as published in 'Academic Research Consortium., Clinical end points in coronary stent trials: a case for standardized definitions.' Circulation 2007; 115: 2344-2351"|9 months|Full Analysis Set (FAS population)||percentage of participants|||Number
816853|NCT01115933|Secondary|Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions) Not Attributable to Target Vessel (NTV-MI)|"Definitions in SPIRIT III Study:
Q wave MI: Development of new, pathological Q wave on the ECG Non-Q wave MI: Elevation of CK levels to >=two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves Per ARC definition as published in 'Academic Research Consortium., Clinical end points in coronary stent trials: a case for standardized definitions.' Circulation 2007; 115: 2344-2351"|1 month|FAS Population||percentage of participants|||Number
816854|NCT01115933|Secondary|Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions) Attributable to Target Vessel (TV-MI)|"Definitions in SPIRIT III Study:
Q wave MI: Development of new, pathological Q wave on the ECG Non-Q wave MI: Elevation of CK levels to >=two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves Per ARC definition as published in 'Academic Research Consortium., Clinical end points in coronary stent trials: a case for standardized definitions.' Circulation 2007; 115: 2344-2351"|9 months|Full Analysis Set (FAS population)||percentage of participants|||Number
816855|NCT01115933|Secondary|Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions) Attributable to Target Vessel (TV-MI)|"Definitions in SPIRIT III Study:
Q wave MI: Development of new, pathological Q wave on the ECG
Non-Q wave MI: Elevation of CK levels to >=two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
Per ARC definition as published in 'Academic Research Consortium., Clinical end points in coronary stent trials: a case for standardized definitions.' Circulation 2007; 115: 2344-2351"|1 month|Full Analysis Set (FAS population)||percentage of participants|||Number
816856|NCT01115933|Secondary|Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions)|"Definitions in SPIRIT III Study:
Q wave MI: Development of new, pathological Q wave on the ECG Non-Q wave MI: Elevation of CK levels to >=two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves Per ARC definition as published in 'Academic Research Consortium., Clinical end points in coronary stent trials: a case for standardized definitions.' Circulation 2007; 115: 2344-2351"|9 months|Full Analysis Set (FAS population)||percentage of participants|||Number
816857|NCT01115933|Secondary|Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions)|"Definitions in SPIRIT III Study:
Q wave MI: Development of new, pathological Q wave on the ECG Non-Q wave MI: Elevation of CK levels to >=two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves Per ARC definition as published in 'Academic Research Consortium., Clinical end points in coronary stent trials: a case for standardized definitions.' Circulation 2007; 115: 2344-2351"|1 month|Full Analysis Set (FAS population)||percentage of participants|||Number
816893|NCT01116232|Primary|Time to Engraftment||During the first six months post transplant|Study terminated due to lack of funding. No analysis, patient data on this protocol due to the fact that only four patients was able to be accrued.|||||
816858|NCT01115933|Secondary|Death (Cardiac, Vascular, Non-Cardiovascular, Per ARC Definition)|DEATH (Per ARC Circulation 2007; 115: 2344-2351) All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.|9 months|Full Analysis Set (FAS population)||percentage of participants|||Number
816859|NCT01115933|Secondary|Death (Cardiac, Vascular, Non-Cardiovascular, Per ARC Definition)|"DEATH (Per ARC Circulation 2007; 115: 2344-2351)
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac."|1 month|||percentage of participants|||Number
816860|NCT01115933|Secondary|Angiographic Binary Restenosis (ABR), In-segment, In-stent, Proximal and Distal|"IN-STENT is defined as within the margins of the stent. IN-SEGMENT is defined as within the margins of the stent and 5 mm proximal and 5 mm distal to the stent.
PROXIMAL is defined as within 5 mm of healthy tissue proximal to stent placement DISTAL is defined as within 5 mm of healthy tissue distal to stent placement"|8 months|Full Analysis Set (FAS population)||percentage of participants||95% Confidence Interval|Number
816861|NCT01115933|Secondary|Late Loss (LL), In-segment, In-stent, Proximal and Distal|"LATE LOSS (LL) calculated as MINIMUM LUMEN DIAMETER [MLD] post-procedure MINUS MLD at follow-up:
In-segment Late Loss: in-segment MLD post-procedure – in segment MLD at follow-up In-stent Late Loss: in-stent MLD post-procedure – in-stent MLD at follow-up Proximal Late Loss: proximal MLD post-procedure – proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to stent placement) Distal Late Loss: distal MLD post-procedure – distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to stent placement)"|8 months|Full Analysis Set (FAS population)||mm||Standard Deviation|Mean
816862|NCT01115933|Secondary|Percent Diameter Stenosis (%DS), In-segment, In-stent, Proximal and Distal|"IN-STENT is defined as within the margins of the stent. IN-SEGMENT is defined as within the margins of the stent and 5 mm proximal and 5 mm distal to the stent.
PROXIMAL is defined as within 5 mm of healthy tissue proximal to stent placement DISTAL is defined as within 5 mm of healthy tissue distal to stent placement"|8 months|Full Analysis Set (FAS population)||percentage of DS||Standard Deviation|Mean
816863|NCT01115933|Secondary|Procedural Success(Subject Base Analysis)|Procedure success is defined as achievement of a final in-stent diameter stenosis of < 50% (by QCA) using the investigational device (AVJ-09-385), without the occurrence MACE during the hospital stay (up to 7 days if a subject still in the hospital). If QCA %DS is not available, the data is not included in analyses.|The period during an in-hospital stay of less than or equal to 7 days post index procedure.|ITT population||percentage of participants||95% Confidence Interval|Number
816864|NCT01115933|Secondary|Device Success (Lesion Based Analysis, Only for XIENCE PRIME SV)|Device success is achievement final in-stent residual diameter stenosis of < 50% (by QCA). If adjunct treatment devices other than protocol defined device is used for target lesion treatment, malfunction of the investigational device occurring during the index procedure, are not regarded as device success. Use of a bail-out stent is still regarded as device success unless a device malfunction has occured. If QCA %DS is not available, the data is not included in analyses.|The period during an in-hospital stay of less than or equal to 7 days post index procedure.|Intent to Treat Population (ITT)||percentage of participants||95% Confidence Interval|Number
816865|NCT01115933|Primary|Composite Endpoint of Cardiac Death/TV-MI/CI-TLR (TLF)|Target lesion failure (TLF) is the composite of any of the following adverse events: Cardiac death, target vessel myocardial infarction (TV-MI) (per Protocol definition), Clinically indicated target lesion revascularization (CI-TLR)|9 Months|Full Analysis Set (FAS population)||percentage of participants|||Number
816866|NCT01115998|Primary|Early Coping Inventory|We used the reactive and self-initiated behavior scales. We used change in raw scores for analyses. The worst possible raw score for each scale is 16 and the best possible score is 80.|Baseline and 12 months|We did a per protocol analysis for 22 children who completed the study and an intention to treat (ITT) analysis for the 28 children for whom we had complete data at 12 months. The overall results of the ITT analysis did not differ from the per protocol analysis.||Units on scale||Inter-Quartile Range|Median
816867|NCT01115998|Primary|Battelle Developmental Inventory (BDI)|Items measure adaptive, cognitive, communication, motor, and personal-social development using 3-point ordinal scales (0 = does not complete; 1 = partially completes; 2 = completes item). We used change in age equivalent scores for each area and the total scores for analyses. The worst possible scores are 0 months age equivalent and the best possible scores are 95 months age equivalent.|Baseline and 12 months|We did a per protocol analysis for 22 children who completed the study and an intention to treat (ITT) analysis for the 28 children for whom we had complete data at 12 months. The overall results of the ITT analysis did not differ from the per protocol analysis.||Units on scale||Inter-Quartile Range|Median
816868|NCT01115998|Primary|Pediatric Evaluation of Disability Inventory|Items measure mobility, self-care, and social function using a 2-point scale (0 = unable or limited ability; 1 = capable in most situations). Items measure caregiver assistance on a 6-point scale (0 = total assistance; 5 = independent). We used the change in scaled scores in each area and total scores for analyses. Worst possible scaled score is 0 and the best possible score is 100.|Baseline and 12 months|We did a per protocol analysis for 22 children who completed the study and an intention to treat (ITT) analysis for the 28 children for whom we had complete data at 12 months. The overall results of the ITT analysis did not differ from the per protocol analysis.||Units on scale||Inter-Quartile Range|Median
816869|NCT01116024|Primary|Hemodynamics - Effective Orifice Area Index|The effective orifice area index is a measure of how much the heart valve prosthesis impedes blood flow through the aortic valve.|Five Years|At discharge Effective Orifice Area index data was collected for 61 subjects.||EOAi (cm2/m2)||Standard Deviation|Mean
816870|NCT01116024|Primary|Hemodynamics - Effective Orifice Area|"Effective orifice area (EOA) data.
The effective orifice area is a measure of how much the heart valve prosthesis impedes blood flow through the aortic valve."|Five Years|At discharge Effective Orifice Area data was collected for 61 subjects.||EOA (cm2)||Standard Deviation|Mean
816871|NCT01116024|Primary|Hemodynamic|Mean and peak pressure gradients from discharge through 5 years follow up. The gradient represents the difference in blood pressure across the valve.|Five Years|At discharge, gradient data was collected of 103 subjects.||mmHg||Standard Deviation|Mean
816872|NCT01116024|Primary|Effectiveness Endpoint - NYHA Classification, Hemodynamic Performance|"New York Heart Association (NYHA) classification to asses improvement of the cardiac status, Hemodynamic Performance analysis based on Doppler echocardiographic studies.
Class I: Patients with cardiac disease but without limitations of ordinary activity.
Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea or anginal pain.
Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity results in fatigue, palpitations or anginal pain.
Class IV: Patients with cardiac disease resulting in inability to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency or anginal syndrome may be present even at rest. If any physical activity is undertaken discomfort is increased."|Five Years|||participants|||Number
816873|NCT01116024|Primary|Re-operation, Explant, Repair|"Reoperation was defined in the protocol as any operation to repair, alter, or replace the study valve. Included is reoperation for repair of paravalvular leak and explant.
The results are reported as linearized rate (percentage of participants per patient-year)."|Five Years|||percentage of participants/patient-year||95% Confidence Interval|Number
816874|NCT01116024|Primary|Non-Structural Dysfunction|"Any abnormality resulting in stenosis or regurgitation at the operated valve that is not intrinsic to the valve itself. Non-structural dysfunction refers to non-structural problems that result in dysfunction of an operated valve exclusive of thrombosis and infection diagnosed by reoperation, autopsy, or clinical investigation.
The results are reported as linearized rate (percentage of participants per patient-year)."|Five Years|||percentage of participants/patient-year||95% Confidence Interval|Number
816875|NCT01116024|Primary|Structural Valve Deterioration|"Structural deterioration was defined as any change in the study valve function which resulted from an intrinsic abnormality that caused stenosis or regurgitation.
There were no cases of structural deterioration reported for the study.
The results are reported as linearized rate (percentage of participants per patient-year)."|Five Years|||percentage of participants/patient-year|||Number
816876|NCT01116024|Primary|Hemolysis|Blood data analysis was performed in order to identify whether particular complications and serious adverse events such as hemolysis occurred. Hemolysis in subjects with tissue valves – as evidenced by increased serum lactate dehydrogenase concentrations, decreased serum haptoglobin concentration, erythrocytopenia and reticulocytosis – is usually associated with paravalvular leakage or infection.|Five Years|||participants|||Number
816877|NCT01116024|Primary|Endocarditis|"Endocarditis was defined in the protocol as any infection involving the study valve. Any structural/non-structural valvular dysfunction, thrombosis, or embolic event associated with study valve endocarditis was captured as endocarditis only.
The results are reported as linearized rate (percentage of participants per patient-year)."|Five Years|||percentage of participants/patient-year||95% Confidence Interval|Number
816878|NCT01116024|Primary|Paravalvular Leaks (All and Major)|"Paravalvular leak was defined as any evidence of leakage of blood around the prosthesis (between the sewing ring and native annulus). Major Paravalvular leak was defined as any evidence of leakage of blood around the prosthesis, i.e. between the sewing ring and native annulus that requires surgical intervention.
The results are reported as linearized rate (percentage of participants per patient-year)."|Five Years|||percentage of participants/patient-year||95% Confidence Interval|Number
816879|NCT01116024|Primary|Hemorrhage/Bleeding-Anticoagulant/Antiaggregant (All and Major)|"Any episode of internal or external bleeding in subjects receiving anticoagulant and/or antiaggregant therapy.
Hemorrhage/Bleeding (No Anticoagulant/Antiaggregant):
Any episode of internal or external bleeding in subjects not receiving anticoagulant and/or antiaggregant therapy.
The results are reported as linearized rate (percentage of participants per patient-year)."|Five Years|||percentage of participants/patient-year||95% Confidence Interval|Number
816880|NCT01116024|Primary|Thromboembolism/Thrombosis|"Valve related thromboembolism and valvular thrombosis.
Thrombosis was defined as any thrombus attached to or near the study valve that interfered with valve function in the absence of infection. The results are reported as linearized rate (percentage of participants per patient-year)"|Five Years|||percentage of participants/patient-year||95% Confidence Interval|Number
816881|NCT01116037|Secondary|Safety Analysis Will be Based on the Occurence of Cardiovascular Complications.|Safety Analysis will be based on the the number of participants with cardiovascular complications.|Six Years|||participants|||Number
816882|NCT01116037|Primary|Primary Efficacy Goal is to Assess the Freedom From Clinically Significant (Moderate or Greater) Aortic Regurgitation for the Patients Implanted With 3f Aortic Bioprothesis, Model 1000|Freedom from clinically significant (moderate or greater) aortic regurgitation will be determined through echocardiography and compared against the freedom from regurgitation event rates from the previous IDE study, G010284 used for PMA approval.|Six Years|||Participants|||Count of Participants
816883|NCT01116102|Secondary|Technical Challenges Encountered During Fluid Infusion|Observed challenges, including catheter kinking, catheter/needle dislodgement/pull-out, infusion pump alarm, other technical problems|at any occurence of a defined challenge or at end of infusion if no challenges occurred|Per Protocol (two subjects excluded due to technical error in in-line fluid pressure measurement)||participants|||Number
816884|NCT01116102|Secondary|Cumulative Fluid Volume Delivered||each minute for the first 15 minutes of fluid infusion, every 5 minutes for the next 45 minutes of infusion, and every 15 minutes thereafter until the end of infusion|Per Protocol (two subjects excluded due to technical errors in fluid pressure measurement)||mL||Full Range|Mean
816885|NCT01116102|Secondary|Number of Attempts Needed for Successful Subcutaneous Catheter/Needle Placement||end of catheter/needle placement|Per Protocol (two subjects excluded due to technical error in in-line fluid pressure measurements)||Subjects|||Number
816886|NCT01116102|Primary|Maximum Measured In-line Fluid Pressure|Maximum fluid pressure measured (15 sec period) in delivery line during subcutaneous fluid infusion at specified time point after start of infusion|each minute for the first 15 minutes of fluid infusion, every 5 minutes for the next 45 minutes of infusion, and every 15 minutes thereafter until the end of infusion|Per protocol (two subjects excluded due to technical error in in-line fluid pressure measurement)||psi||Full Range|Mean
816887|NCT01116232|Secondary|Immunocorrelative Studies Pre- and Periodically Post-transplantation||Using flow cytometry at 30, 60, 90, and 180 days post transplant.||||||
816888|NCT01116232|Secondary|Overall and Disease-free Survival||At 1 year||||||
816889|NCT01116232|Secondary|Incidence of Thrombotic Microangiopathy||Within 100 days of HCT||||||
816924|NCT01116882|Secondary|Met Indication Criteria for PCI|Included here are the number of treated lesions that met the class I or II recommendations for anatomical indications for PCI, according to the PCI guidelines fo the American College of Cardiology Foundation-American Heart Association-Society for Cardiovascular Angiography and Interventions.|Post-Procedure|||lesions|Participants||Number
816909|NCT01116466|Secondary|Change in MRI of Affected Leg and Implant Post-implantation|MRI will be conducted to evaluate the impact of the implant on the common peroneal nerve (e.g. positioning of the nerve cuff along the nerve, path of the lead wire and the common peroneal nerve, estimation of the cross-sectional area of the common peroneal nerve compared to the pre-operative MRI recording, etc.)|Week 3 post-implantation||||||
816910|NCT01116466|Secondary|Nerve Conduction Velocity of the Peroneal Nerve|Measured: Nervus peroneus communis (CPN) and Nervus peroneus superficialis (SPN)|Baseline, week 12 post-implantation|Two subjects were unavailable for the test.||m/s||Standard Deviation|Mean
816911|NCT01116466|Secondary|Four Square Step Test (FSST)|It is a test of dynamic balance that clinically assesses the person's ability to step over objects forward, sideways, and backwards. The patient's time to perform the test is measured which shorter time representing better performance. At baseline this test was done with subject's conventional walking aid. At 12 weeks post-implantation it was done with and without stimulation.|Baseline, week 12 post-implantation|||s||Standard Deviation|Mean
816912|NCT01116466|Secondary|Canadian Occupational Performance Measure (COPM) Score|A semi-structured interview is conducted in order to identify subject's limitations with daily occupations of importance in categories self-care, productivtiy or leisure. The subject is then asked to rate the imporance of each of the occupations using a 10-point rating scale. Afterwards the subject chooses up to 5 of the most important occupations (problems) (basis for identifying intervention goals). The subject is asked to use a 10 point scale to rate level of performance and satisfaction with performance for each of the five identified problems. Average COPM performance score and satisfaction score are calculated. The scores range between 1 and 10, where 1 indicates poor performance and low satisfaction, respectively, while 10 indicates very good performance and high satisfaction.|Baseline,12 weeks post-implantation|Two subjects were not available for the test.||units on a scale||Standard Deviation|Mean
816913|NCT01116466|Secondary|Walking Speed During 10 Meter Gait Test|The test assesses walking speed in meters per second over a short duration. At baseline this test was done with subject's conventional walking aid. At 6 and 12 weeks post-implantation this was done with and without stimulation.|Baseline, 6 and 12 weeks post-implantation|||m/s||Standard Deviation|Mean
816914|NCT01116466|Primary|Distance Walked in 6 Minutes|The test assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity (endurance). At baseline this test was done with subject's conventional walking aid. At 6 and 12 weeks post-implantation this was done with and without stimulation.|Baseline, 6 and 12 weeks post-implantation|||m||Standard Deviation|Mean
816915|NCT01116687|Secondary|Number of Related Serious Adverse Events (SAEs)|Study drug related grade 3-4 toxicities. To measure Adverse Events, investigators used the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.|Study duration of 12 months|All evaluable participants||events|||Number
816916|NCT01116687|Secondary|Participant Progression Free Survival (PFS) Rate|Progression-Free Survival defined as the time from start of treatment until disease progression or death as a result of any cause. Patients were re-evaluated for response every 8 weeks. Response and progression were evaluated using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) [Eur J Ca 45:228-247, 2009]. Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the RECIST criteria.|Study duration of 12 months|All evaluable participants||months||95% Confidence Interval|Median
816917|NCT01116687|Secondary|Participant Overall Survival (OS) Rate|Overall Survival defined as the time from start of treatment until death as a result of any cause, with patients censored at the date of last follow-up if still alive. The Kaplan-Meier method was used to estimate all time-to-event functions. Statistical analysis was performed using Stata SE 9.0 software and SAS 9.2 software.|Study duration of 12 months|All evaluable participants||months||95% Confidence Interval|Median
816918|NCT01116687|Primary|Number of Participants With Objective Radiographic Response (ORR)|To determine the objective radiographic response rate associated with RO4929097 in patients with metastatic colorectal cancer who have progressed following at least 2 prior treatments in the metastatic setting. Radiologic assessment of tumor burden (CT scans of the chest, abdomen and pelvis, or MRI of the abdomen and pelvis and CT of the chest) was scheduled every 8 weeks. Response Evaluation Criteria in Solid Tumors (RECIST version 1.1) were used for evaluation of the primary endpoint.|2 months from enrollment for each participant|All evaluable participants||participants|||Number
816941|NCT01116921|Primary|Need for Intubation and Mechanical Ventilation in the First Seven Days of Life.|“Treatment Failure” criteria were the same for both groups. “Treatment Failure” required two of the following: 1) FiO2 >40% for longer than 30 minutes (to maintain SaO2 88-92%), 2) PCO2 >65mmHg on ABG/CBG or >70 on VBG, or 3) pH<7.22 on ABG/CBG/VBG or one of the following: 1) recurrent or severe apnea, 2) hemodynamic instability requiring pressors, 3) repeat surfactant dose at appropriate time with FiO2 >40%, or 4) deemed necessary by medical provider.|Seven days|||Participants|||Count of Participants
816942|NCT01116934|Primary|Serum Concentrations of Interleukin (IL)-1 Beta|Concentrations of IL-8, IL-6, IP-10, interferon (IFN)-gamma, and IL-1 beta, in plasma/RPMI samples were determined by enzyme linked immunosorbent assay (ELISA) according to the manufacturers’ instructions|2006|Samples were stimulated with 100 ng/ml lipopolysaccharide (LPS)||pg/ml||Inter-Quartile Range|Median
816943|NCT01116986|Primary|Self-Reported 7-Day Point-Prevalence Abstinence|"Self-Reported 7-Day Point-Prevalence Abstinence is a dichotomous outcome with values of 0 and 1 where 0=smoking on one or more of the past 7 days at the assessment endpoint (16 weeks post-quit) and 1=no smoking on any of the past 7 days at the assessment endpoint (i.e., abstinent for the past 7 days); this outcome will be analyzed in a logistic regression analysis model.
Note: This abstinence primary outcome replaces latency to relapse (now designated as a secondary outcome) because reviewers of the now-accepted manuscript (at the journal Addiction) advised us to change the primary outcome to the current week 16 Self-Reported 7-Day Point-Prevalence Abstinence outcome."|16 weeks post-quit|||participants|||Number
816944|NCT01116986|Secondary|Latency to Relapse|Latency to Relapse during the first 6 months post-quit, with relapse defined as 7 consecutive days of smoking; this outcome will be analyzed in a Cox regression survival analysis model with non-relapsers coded as right-censored.|During the first 6 months post-quit|||participants|||Number
816945|NCT01117012|Secondary|Absolute Change From Study 105 Baseline in Weight Through Week 96|Weight is a measurement of nutritional status. Absolute change in weight, measured in kilograms (kg), at Week 48 and Week 96 are reported.|Study 105: Baseline through Week 96|Full Analysis Set. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure and n signifies participants who were evaluable for specified categories for each arm, respectively.||kg||Standard Deviation|Mean
816946|NCT01117012|Secondary|Annualized Duration of Pulmonary Exacerbation Events||Study 105: Day 1 through Week 96|Full Analysis Set.||Days per year||Standard Deviation|Mean
816947|NCT01117012|Secondary|Annualized Pulmonary Exacerbation Event Rate|Annualized event rate was calculated by regression with negative binomial distribution.|Study 105: Day 1 through Week 96|Full Analysis Set.||events per year|||Number
816948|NCT01117012|Secondary|Absolute Change From Study 105 Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score Through Week 96|The CFQ-R is a validated patient-reported outcome measuring health-related quality of life for subjects with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life. Absolute Change at Week 48 and Week 96 are reported.|Study 105: Baseline through Week 96|Full Analysis Set. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure and n signifies participants who were evaluable for specified categories for each arm, respectively.||units on a scale||Standard Deviation|Mean
816949|NCT01117012|Secondary|Absolute Change From Study 105 Baseline in Percent Predicted FEV1 Through Week 96|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Predicted FEV1 (for age, gender, and height) was calculated using the Knudson method. Baseline was defined as the most recent measurement prior to intake of the first dose of study drug in Study 105. Absolute Change at Week 48 and Week 96 are reported.|Study 105: Baseline through Week 96|Full Analysis Set. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure and n signifies participants who were evaluable for specified categories for each arm, respectively.||percent predicted of FEV1||Standard Deviation|Mean
816950|NCT01117012|Secondary|Annualized Rate of Decline From Study 105 Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through Week 96|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Predicted FEV1 (for age, gender, and height) was calculated using the Knudson method. Baseline was defined as Study 105 Day 15.|Study 105: Baseline through Week 96|Full Analysis Set.||percent predicted of FEV1 per year||95% Confidence Interval|Least Squares Mean
816951|NCT01117012|Primary|Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs)|Adverse Event: any untoward medical occurrence in a participant during the study, including any unfavorable and unintended sign, symptom, or disease whether or not it was considered to be study drug related. This included any newly occurring event or previous condition that increased in severity or frequency after obtaining informed consent and assent (where applicable). SAE: medical event or condition, which resulted in any of following, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolonged hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect, important medical event. Non-Serious AEs included all AEs except SAEs.|Study 105: Day 1 up to Week 168|Safety Set included all participants who received at least 1 dose of study drug during Study 105.||participants|||Number
816952|NCT01117051|Secondary|Plasma Concentration of Prucalopride at Week 8||Week 8|ITT (subjects in the ITT whose post-dose samples were collected outside the 5-hour sampling window were not used in the plasma concentration calculation)||ng/ml||Standard Deviation|Mean
816953|NCT01117051|Secondary|Plasma Concentration of Prucalopride at Week 2||Week 2|ITT (subjects in the ITT whose post-dose samples were collected outside the 5-hour sampling window were not used in the plasma concentration calculation)||ng/ml||Standard Deviation|Mean
816954|NCT01117051|Primary|Percent of Subjects With an Average Frequency of >=3 Spontaneous Bowel Movements Per Week|A bowel movement (BM) was defined as spontaneous if no laxatives were taken in the 24 hours preceding that BM.|12 weeks|Intent-to-Treat (ITT) population includes all subjects who were randomized into the study and who had received at least 1 dose of investigational medication.||percentage of subjects|||Number
816992|NCT01117428|Primary|Number of Participants With Adverse Events (AEs)|The AEs were used as a primary endpoint. AEs were summarized using descriptive statistics and presented overall by system organ class and preferred term. The frequencies of AEs were presented including number and percentages of participants with events and the total number of events.|Visit 2 until first follow-up visit (up to 66 weeks)|||Participants|||Count of Participants
816955|NCT01117090|Secondary|The Relationship Between CSF Pressure Data and Physician's Standard Trouble-shooting Diagnosis During Physical Task Protocol: Valsalva|Collect and characterize, by comparison with the physician's standard trouble-shooting diagnosis, the mean change in CSF pressure data during the physical task of a valsalva maneuver|1 day|Subjects were excluded if the needle was not in the CAP, if they had a ventricular catheter, if the pressure sensor malfunctioned, if there was an issue with the equipment, if the subject was unable to perform the valsalva, or if data were missing.||mmHg||Standard Deviation|Mean
816956|NCT01117090|Secondary|The Relationship Between CSF Pressure Data and Physician's Standard Trouble-shooting Diagnosis During Physical Task Protocol: Cough|Collect and characterize, by comparison with the physician's standard trouble-shooting diagnosis, the mean change in CSF pressure data during the physical task of a cough|1 day|Subjects were excluded if the needle was not in the CAP, if they had a ventricular catheter, if the pressure sensor malfunctioned, if there was an issue with the equipment, or if the subject was unable to cough.||mmHg||Standard Deviation|Mean
816957|NCT01117090|Secondary|The Relationship Between Catheter Flow Resistance Check Data and Physician's Standard Trouble-shooting Diagnosis|Characterize the relationship between pressure decay-to-baseline time (in seconds) and the physician's standard trouble-shooting diagnosis|1 day|Subjects were excluded if the needle was not in the CAP, if they had a ventricular catheter, if the pressure sensor malfunctioned, if there was an issue with the equipment, if the clamp was not open, or if the resistance check data were missing.||seconds||Standard Deviation|Mean
816958|NCT01117090|Primary|Classification of Catheter Function by CSF Signatures vs. Physician's Standard Trouble-shooting Diagnosis|Collect and characterize, by comparison with the physician's standard trouble-shooting diagnosis, CSF signatures recorded in subjects who have an infusion system who present with signs and/or symptoms of possible catheter-related problems or failure.|1 day|Subjects were excluded if the needle was not in the CAP, if they had a ventricular catheter, if the pressure sensor malfunctioned, or if there was an issue with the equipment||Subjects whose CSF data agree with MD Dx|||Number
816959|NCT01117181|Secondary|Electrocardiogram (ECG)|Abnormal electrocardiogram results at 6 weeks|6 weeks|||participants with abnormal ECG|||Number
816960|NCT01117181|Secondary|Electrolytes|Percent abnormal at 6 weeks as assessed by local lab|6 weeks|One patient in the active group completed all visit 6 assessments except for the blood collection for the electrolyte sample. This patient refused this procedure.||percentage of abnormal electrolyte value|||Number
816961|NCT01117181|Secondary|Vital Status|vital status as measured by death|vital status at 6 weeks|||number of participants who died|||Number
816962|NCT01117181|Secondary|Neuropsychiatric Inventory (NPI): Apathy Subscale|Change from baseline to 6 weeks in neuropsychiatric symptoms in apathy subscore. Frequency (ranges from 1=occasionally, less than once/week to 4 = very frequently, once or more/day or continuously) and severity (1=mild, 2=moderate, 3=severe) scales are scored based on responses from an informed caregiver involved in the patient's life. To obtain the NPI score, the severity score is multiplied by the frequency score. Range is 0 to 12. Larger numbers indicate more severe behavioral disturbance.|baseline to week 6|||change in NPI apathy score||Standard Error|Mean
816963|NCT01117181|Secondary|Mini-Mental State Exam (MMSE)|Change in Mini-Mental State Exam score from baseline to 6 weeks; this cognitive test estimates of dementia severity. Domains included orientation, memory, working memory, naming, following verbal and written commands, spontaneously writing a sentence, and copying two overlapping pentagons. The minimum MMSE score is 0; the maximum MMSE score is 30. Lower MMSE scores indicate more severe cognitive impairment.|baseline and 6 weeks|||change in MMSE score||Standard Error|Mean
816964|NCT01117181|Secondary|Digit Span|Change in Digit Span at baseline and 6 weeks; this assessment is used to assess auditory attention and working memory. Higher numbers indicate better functioning.|baseline and 6 weeks||08/2013||||
816965|NCT01117181|Primary|Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change|"Proportion of individuals improving on Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (CGIC) from baseline to 6 weeks; the CGIC is a 7-point Likert scale used to rate each patient with the following scores: marked worsening(7), moderate worsening (6), minimal worsening(5), no change(4), minimal improvement(3), moderate improvement(2), marked improvement(1). Ratings were based on an interview with the caregiver and an examination of the patient. The CGIC requires the clinician to consider a number of aspects of apathy, such as level of initiative, level of interest, and emotional engagement."|baseline to 6 weeks|||% patients moderate/marked improvement|||Number
816966|NCT01117181|Primary|Apathy Evaluation Scale (AES)|Change in score of Apathy Evaluation Scale from baseline to 6 weeks; the minimum score is 18; the maximum score is 72. Higher scores indicate more severe apathy.|baseline to 6 weeks|||change in score on AES||Standard Error|Mean
816967|NCT01117311|Secondary|Gastric Emptying Half-time|Gastric emptying half time is the time for half of the ingested solids or liquids to leave the stomach.|approximately 2 hours after radiolabeled meal is ingested|||minutes||Standard Error|Mean
816968|NCT01117311|Primary|Disposition Index|Total Disposition Index (DI) is a calculated value which represents the ability of a person's pancreas to lower blood glucose. A higher number means the pancreas is better able to lower blood glucose and a lower number means the pancreas is less able to lower blood glucose.|baseline, 2 weeks|||10^-14dl/kg/min^2 per pmol/l||Standard Error|Mean
816969|NCT01117337|Secondary|Seroma Formation|A seroma was defined as a non tender, irreducible hemispherical swelling with a fluctuant or firm consistency at the hernia site, examined and found during the first year. The diagnosis was based on the clinical finding of a palpable fluid collection without a size limit. One could get above the upper border of the swelling and there was usually absence of a cough impulse. To detect seroma, the clinical examination was carried at the first follow-up visit on the 7th postoperative day.|One year|||Participant|||Number
816970|NCT01117337|Primary|Proportion of Patients Having Pain in the Post Operative Period|To compare the proportion of patients having pain in the mesh fixation and non fixation group at one month postoperatively.|1 month|||Participant|||Number
816993|NCT01107535|Secondary|Number of Serious Adverse Events|The number participants experiencing a serious adverse event. For additional information see the Reported Adverse Events section.|Enrollment until 100 days after the last Synagis (palivizumab) dose|Analysis included all enrolled participants.||participants|||Number
825580|NCT01192139|Secondary|Metformin Tmax||Periods 1, 2, and 3 (before dosing, 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)|All treated participants||hours||Standard Deviation|Mean
816971|NCT01117337|Primary|Recurrence of Inguinal Hernia on the Operated Side in Mesh Non-fixation and Mesh Fixation Group.|Patients in both the arms will be followed up post operatively at 24 hours, 1 week, 1 month and 1 year to check for recurrence or persistence of inguinal hernia on the operated side. At these follow up visits, the patients would be asked about reoccurence of bulge on the operated side and will be examined clinically. In case, there is a suspicion of recurrence, the patient would be examined by a second surgeon and undergo Ultrasound and/or CT to confirm the recurrence of hernia.|1 year|||Participant|||Number
816972|NCT01117350|Secondary|Hypoglycemia Occurence: Number of Patients With at Least One Episode of Symptomatic / Severe Symptomatic Hypoglycemia During the Extension Period|"Symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemia.
Severe symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemia, requiring the assistance of another person for active administration of carbohydrate, glucagon or other countermeasure because the patient could not treat him/herself due to acute neurological impairment directly resulting from the hypoglycemia (assistance by another person when the patient could have treated him/herself was not considered as requiring assistance)and one of the following criteria:
The event was associated with a measured PG level < 36 mg/dL (2 mmol/L),
Or, in absence of PG value, the event was associated with neurological recovery attributable to the restoration of PG to normal, after oral carbohydrate, intravenous glucose or glucagon administration."|all across the extension period (from week 24 to week 48)|The population analyzed was the safety population (extension) i.e. all treated patients during the extension period.||participants|||Number
816973|NCT01117350|Secondary|Hypoglycemia Occurence: Number of Patients With at Least One Episode of Symptomatic / Severe Symptomatic Hypoglycemia During the Comparative Period|"Symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemia.
Severe symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemia, requiring the assistance of another person for active administration of carbohydrate, glucagon or other countermeasure because the patient could not treat him/herself due to acute neurological impairment directly resulting from the hypoglycemia (assistance by another person when the patient could have treated him/herself was not considered as requiring assistance)and one of the following criteria:
The event was associated with a measured PG level < 36 mg/dL (2 mmol/L),
Or, in absence of PG value, the event was associated with neurological recovery attributable to the restoration of PG to normal, after oral carbohydrate, intravenous glucose or glucagon administration."|all across the comparative period (from week 0 to week 24)|The population analyzed was the safety population i.e. all randomized and treated patients.||participants|||Number
816974|NCT01117350|Secondary|Daily Dose of Insulin Glargine Administered During the Extension Period||week 30, week 36, week 48|The population considered was the mITT population (extension) but due to missing values, different subsets of this mITT population were analyzed at each week.||Unit (U)||Standard Deviation|Mean
816975|NCT01117350|Secondary|Daily Dose of Liraglutide||week 1, week 2, week 6, week 12, week 24|The population considered was the mITT population but due to missing values, different subsets of this mITT population were analyzed at each week.||mg||Standard Deviation|Mean
816976|NCT01117350|Secondary|Daily Dose of Insulin Glargine||week 1, week 2, week 6, week 12, week 24|The population considered was the mITT population but due to missing values, different subsets of this mITT population were analyzed at each week.||Unit (U)||Standard Deviation|Mean
816977|NCT01117350|Secondary|Body Weight: Change From Beginning to End of the Extension Period|Change = Last weight value measured during the extension period (LOCF value) - weight value at beginning of the Extension Period (Week 24)|week 24, week 30, week 36, week 48|The population analyzed for this outcome measure consisted of the mITT population (extension).||kg||Standard Deviation|Mean
816978|NCT01117350|Secondary|Body Weight: Change From Baseline to the End of the Comparative Period|Change = Last weight value measured during the comparative period (LOCF value) - weight value at baseline|baseline (week 0), week 2, week 6, week 12, week 18, week 24|The population analyzed for this outcome measure consisted of the subset of mITT patients who had at least one weight value on treatment during the comparative period.||kg||Standard Deviation|Mean
816979|NCT01117350|Secondary|Self-Monitored 7-point Plasma Glucose (PG) Profile: Change From Beginning to the End of the Extension Period|"Self-monitored 7-point plasma glucose profiles (before and 2 hours after the start of breakfast, lunch and dinner, and at bedtime) recorded on 3 consecutive days in the week before each visit
Value at the end of the extension period defined as last available value during the extension period (i.e. last-observation-carried-forward [LOCF] value)
Change = LOCF value - week 24 value"|week 24, week 36, week 48|The population considered was the mITT population (extension) but due to missing values, different subsets of this population were analyzed for each time point of the profile.||mg/dL||Standard Deviation|Mean
816980|NCT01117350|Secondary|Self-Monitored 7-point Plasma Glucose (PG) Profile: Change From Baseline to the End of the Comparative Period|"Self-monitored 7-point plasma glucose profiles (before and 2 hours after the start of breakfast, lunch and dinner, and at bedtime) recorded on 3 consecutive days in the week before each visit
Value at the end of the comparative period defined as last available value during the comparative period (i.e. last-observation-carried-forward [LOCF] value)
Change = LOCF value - baseline value"|baseline (week 0), week 12, week 24|The population considered was the mITT population but due to missing values, different subsets of this mITT population were analyzed for each time point of the profile.||mg/dL||Standard Deviation|Mean
816981|NCT01117350|Secondary|Self-Monitored Fasting Plasma Glucose (SMFPG) Measurements: Change From Beginning to the End of the Extension Period|"SMFPG = mean value of Self-Monitored Fasting Plasma Glucose measurements over 3 consecutive days in the week before each visit
Value at the end of the extension period defined as last available value during the extension period (i.e. last-observation-carried-forward [LOCF] value)
Change = LOCF value - week 24 value"|week 24, week 30, week 36, week 48|The population analyzed for this outcome measure consisted of the subset of mITT (extension) patients who had SMFPG value both at beginning of the extension and at least one value on treatment during the extension period.||mg/dL||Standard Deviation|Mean
817073|NCT01119443|Secondary|Cmin,ss (Fed Conditions)|Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ|Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration|One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set||ng/mL||Standard Deviation|Geometric Mean
816982|NCT01117350|Secondary|Self-Monitored Fasting Plasma Glucose (SMFPG) Measurements: Change From Baseline to the End of the Comparative Period|"SMFPG = mean value of Self-Monitored Fasting Plasma Glucose measurements over 3 consecutive days in the week before each visit
Value at the end of the comparative period defined as last available value during the comparative period (i.e. last-observation-carried-forward [LOCF] value)
Change = LOCF value - baseline value"|baseline (week 0), week 6, week 12, week 18, week 24|The population analyzed for this outcome measure consisted of the subset of mITT patients who had at least one SMFPG value on treatment during the comparative period.||mg/dL||Standard Deviation|Mean
816983|NCT01117350|Secondary|Percentage of Patients Whose Glycosylated Haemoglobin (HbA1c) <7% at the End of the Extension Period|Value at the end of the extension period defined as last available HbA1c value measured during the extension period (i.e. last observation carried forward (LOCF) value)|week 36, week 48|The population analyzed for this outcome measure consisted of the mITT patients who had at least one HbA1c value on treatment during the extension period.||percentage of participants|||Number
816984|NCT01117350|Secondary|Glycosylated Haemoglobin (HbA1c): Change From Beginning to the End of the Extension Period|Change in HbA1C from beginning of the extension period (week 24) to the last observation carried forward (LOCF) measured during the extension period = LOCF value - week 24 value|week 24, week 36, week 48|The population analyzed for this outcome measure consisted of the subset of mITT population (extension) who had HbA1c value both at beginning of the extension and at least one value on treatment during the extension period.||percent||Standard Deviation|Mean
816985|NCT01117350|Secondary|Glycosylated Haemoglobin (HbA1c): Change From Baseline to the End of Comparative Period|Change in HbA1C from baseline to the last observation carried forward (LOCF) measured during the comparative period = LOCF value - baseline value|baseline (week -2), week 12, week 24|The population analyzed for this outcome measure consisted of the subset of mITT patients who had at least one HbA1c value on treatment during the comparative period.||percent||Standard Deviation|Mean
816986|NCT01117350|Secondary|Percentage of Patients Whose Glycosylated Haemoglobin (HbA1c) Has Increased at the End of the Comparative Period|Percentage of patients with HbA1c value at end of the comparative period (LOCF) higher than HbA1c baseline value|baseline (week -2), week 12, week 24|The population analyzed for this outcome measure consisted of the subset of mITT patients who had at least one HbA1c value on treatment during the comparative period.||percentage of participants|||Number
816987|NCT01117350|Secondary|Percentage of Patients Whose Glycosylated Haemoglobin (HbA1c) Has Decreased But Remains ≥7% at the End of the Comparative Period|"Percentage of patients with:
* HbA1c value at end of the comparative period (LOCF) lower than HbA1c baseline value
AND
* HbA1c value at end of the comparative period (LOCF) ≥7%"|baseline (week -2), week 12, week 24|The population analyzed for this outcome measure consisted of the subset of mITT patients who had at least one HbA1c value on treatment during the comparative period.||percentage of participants|||Number
816988|NCT01117350|Primary|Percentage of Patients Whose Glycosylated Haemoglobin (HbA1c) <7% at the End of the Comparative Period|The value at the end of the comparative period was defined as the last available HbA1c value measured during the comparative period plus 14 days after the last dose of Investigational Product (i.e. last-observation-carried-forward [LOCF] value).|week 12, week 24|The population analyzed for this outcome measure consisted of the subset of mITT patients who had at least one HbA1c value on treatment during the comparative period.||percentage of participants|||Number
816989|NCT01117428|Secondary|Terminal Half-Life (T½)|"For Part A, the endpoint was not calculated. For Parts B, C and F, the endpoint was calculated for each patient following the first and fourth Sym004 infusions.
For Parts D and E, the endpoint was calculated for each patient following the first and third Sym004 infusions.
T½ was estimated using non-compartmental methods and actual time points.
Outcome Measure Time Frame:
Parts B, C and F (Weekly dosing): Sample collection at Visit 2 (1st dose from end of infusion, 1-, 2-, 4-, 8-, 24-, 48-hours) until 1 week post-infusion (168-hours) and at Visit 5 (4th dose from end of infusion, 1-, 2-, 4-, 8-, 24-hours) until 1 week post-infusion (168-hours).
Parts D, E (Dosing every second week): Sample collection at Visit 2 (1st dose from end of infusion, 1-, 2-, 4-, 8-, 24-, 48-hours) to end of 3rd dose (from end of infusion, 1-, 2-, 4-, 8-, 24-hours) until 2 weeks post-infusion (336 hours)."|See Time Frame in the Outcome Measure Description|For Part A, data could not be reported as the endpoint was not calculated and no pharmacokinetics (PK) analysis set was defined. For Parts B to F, a PK analysis set was used.||Hours||Geometric Coefficient of Variation|Geometric Mean
816990|NCT01117428|Secondary|Antitumor Activity Endpoints - Time-to-event Endpoints|"Median Progression Free Survival (PFS) was defined as the time interval without PD from start of first infusion until death or documented PD (i.e. at least a 20% increase in the sum of diameters of target lesions) according to RECIST v1.1. Patients who died without confirmed PD were considered as progressed. Patients who died or showed PD more than 21 days after last treatment were censored (i.e. were considered alive without progression on Day 21 after last treatment). Patients without events were censored at date of last scan or 22 days after last treatment, whichever occurred first.
Median Overall Survival (OS) was defined as the time from start of first infusion until date of death from any cause. Patients alive at the time of the analysis or prematurely withdrawn from the trial (e.g. lost to follow-up or consent withdrawn) were censored for the OS analysis. In any case of censoring, the date of censoring was the last time point documenting survival status."|Up to 62 weeks|||Months||95% Confidence Interval|Median
816991|NCT01117428|Secondary|Antitumor Activity|Best Overall Response (OR) on the Full Analysis Set (FAS) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, based on central evaluation with confirmatory CT scan or MRI [Complete Response (CR): disappearance of all target lesions; Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions; Progressive Disease (PD): at least a 20% increase in the sum of diameters of target lesions; Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Overall Response (OR): CR + PR]. Baseline was defined as Visit 2 (pre-infusion). The outcome measure was measured from screening until PD.|Up to 62 weeks|Data for Part A were presented only for the FAS. For Parts B to F, analyses and summaries were performed both for the FAS and for the per protocol population. The FAS was considered the primary analysis population.||percentage of participants||95% Confidence Interval|Number
817116|NCT01119755|Primary|Mean Difference of Systolic Night-time Ambulatory Blood Pressure Between Summer and Winter|Mean difference of systolic night-time ambulatory blood pressure measurement during summer and winter period|1 year|||mmHg||Standard Deviation|Mean
816994|NCT01107535|Secondary|Number of Ventilation Support Days (Supplemental Oxygen and Mechanical Ventilation) During the Hospital Admission|The mean (average) number of days participants required supplemental oxygen during any hospital stay and the mean number of days participants required mechanical ventilation while in the intensive care unit.|Hospital admission to hospital discharge|Analysis of supplemental oxygen included participants with any hospital stay during the study (n=10) and analysis of mechanical ventilation included the subgroup of participants with intensive care unit stays during the study (n=2).||days||Standard Deviation|Mean
816995|NCT01107535|Secondary|Number of Intensive Care Unit Days During the Hospital Admissions by Respiratory Syncytial Virus Infection|The number of days spent in a hospital intensive care unit (ICU) are summarized for those participants requiring that type of care. An indirect immunofluorescence test (a laboratory technique used to detect the presence of viruses) was used to determine if hospitalized participants had respiratory syncytial virus infection.|Hospital admission to hospital discharge|Two participants with a total of 3 intensive care unit stays were analyzed. One participant was negative for respiratory syncytial virus during their first stay in the intensive care unit and was positive for respiratory syncytial virus at their second stay.||days|||Number
816996|NCT01107535|Secondary|Number of Hospital Admission Days (All Causes)|The mean (average) number days participants were hospitalized.|Hospital admission to hospital discharge|Analysis included all participants who were hospitalized during the study. This includes 2 participants hospitalized due to respiratory syncytial virus infection and 8 participants hospitalized for other respiratory diseases.||days||Standard Deviation|Mean
816997|NCT01107535|Primary|Number of Hospital Admissions by Respiratory Syncytial Virus Infection|The number of participants hospitalized for respiratory syncytial virus infection from the first dose of study drug up to the visit coinciding with the first birthday of the participant. An indirect immunofluorescence test (a laboratory technique used to detect the presence of viruses) was used to determine if hospitalized participants had respiratory syncytial virus infection.|First year of life (up to 12 months)|Analysis included all enrolled participants.||participants|||Number
816998|NCT01117454|Primary|Number of Patients With Ventricular Ectopy or VT During Exercise Treadmill Testing|Hypothesis: the addition of oral flecainide to standard therapy will reduce ventricular ectopy and/or VT on treadmill exercise treadmill testing in patients with CPVT, compared to placebo plus standard therapy.|3 months|1 participant did not complete treadmill test||Participants|||Count of Participants
816999|NCT01117480|Secondary|Mean Change From Baseline (Month 0) in Rheumatoid Arthritis Disease Activity Index (RADAI)|The RADAI is a questionnaire for participants used for measuring disease activity. The index consists of 6 questions. The items ask the participants about (1) global disease activity in the last 6 months, (2) disease activity in terms of current swollen and tender joints, (3) arthritis pain, (4) the current status of health, (5) duration of morning stiffness and (6) tender joints to be rated in a joint list. The joint list asks about pain in the left and right shoulders, elbows, wrists, fingers, hips, knees, ankles and toes. The first 3 items are all rated on a numeric rating scale from 0 to 10, where higher scores indicate more disease activity. The RADAI total score is the sum of individual items divided by 5 (range 0-10), with a higher score signifying more disease activity.|Month 0, 6, 12, 18 and 24|Analyses included all participants who received at least 1 dose of adalimumab (ITT) with baseline data available for RADAI.||units on a scale||Standard Deviation|Mean
817000|NCT01117480|Secondary|Mean Change From Baseline (Month 0) in Health Assessment Questionnaire (HAQ)|Physical function was evaluated using the Health Assessment Questionnaire - Disability Index (HAQ-DI), a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from baseline in the disability index of the HAQ-DI indicated improvement.|Month 0, 6, 12, 18 and 24|Analyses included all participants who received at least 1 dose of adalimumab (ITT) with baseline data available for HAQ.||units on a scale||Standard Deviation|Mean
817001|NCT01117480|Primary|Percentage of Participants That Achieved a Disease Activity Score 28 (DAS28) < 2.6|The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR), and the Subject’s Global Assessment of Disease Activity (subject rates disease activity using a likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.|Month 0, 6, 12, 18 and 24|Analyses included all participants who received at least 1 dose of adalimumab (ITT) with baseline data available for DAS-28.||percentage of participants|||Number
817002|NCT01117623|Other Pre-specified|Tumor Response in Expansion Cohort|Tumor Response (= Best Overall Response) of a participant was defined as the best tumor response (Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)) observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR was defined as disappearance of tumor lesions, PR was defined as a decrease of at least 30% in the sum of tumor lesion sizes, SD was defined as steady state of disease, PD was defined as an increase of at least 20% in the sum of tumor lesions sizes.|From the screening visit of the first participant until the last evaluation of the final participant over 6 years later, assessed at the screening visit, end of cycle 2, end of each even cycle and during the final visit (end of treatment)|ITT efficacy analysis (set), expansion cohorts only||Participants|||Number
817012|NCT01117623|Secondary|Time to Reach Maximum Observed Plasma Concentration at Steady State (Tmax,ss)|Tmax,ss refers to the time after multiple dose administration and after a steady state concentration has been reached when a drug attains its highest measurable concentration (Cmax). It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content.|Blood samples were collected on Cycle 2, Day 1 and on Cycle 3, Day 1 for expansion cohort. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10 and 24h post-dose|Pharmacokinetic population; Number of Participants with an evaluable Tmax,ss in at least one analyte were 6 in 40mg; 6 in 100 mg; 2 in 120 mg; 3 in 140 mg; 0 in HCC Child Pugh A; 1 in HCC Child Pugh B; 5 in NSCLC||h||Full Range|Median
817003|NCT01117623|Other Pre-specified|Tumor Response in Dose Escalation Cohort|Tumor Response (= Best Overall Response) of a participant was defined as the best tumor response (Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)) observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR was defined as disappearance of tumor lesions, PR was defined as a decrease of at least 30% in the sum of tumor lesion sizes, SD was defined as steady state of disease, PD was defined as an increase of at least 20% in the sum of tumor lesions sizes.|From the screening visit of the first participant until the last evaluation of the final participant over 6 years later, assessed at the screening visit, end of cycle 2, end of each even cycle and during the final visit (end of treatment)|ITT efficacy analysis (set)||Participants|||Number
817004|NCT01117623|Other Pre-specified|Tumor Progression in Expansion Cohort|Tumor progression evaluates changes in a tumor or tumors over time due to worsening of disease. Measurements and observations of the tumor status were performed before, during and after treatment. Tumor progression evaluates changes in a tumor or tumors over time due to worsening of disease. Measurements and observations of the tumor status were performed before, during and after treatment. Progression for solid tumors was evaluated based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.0) criteria. Tumor dimensions were measured in millimeters and the longest diameter (LD) was recorded for up to 5 lesions per organ and 10 lesions total. A sum of the LD for all target lesions was recorded. The use of a 20% increase in the sum of LD of target lesions from the smallest sum or appearance of a new lesion was assessed as progression of disease.|From the screening visit of the first participant until the last evaluation of the final participant over 6 years later, assessed at the screening visit, end of cycle 2, end of each even cycle and during the final visit (end of treatment)|ITT efficacy analysis (set), expansion cohorts only||Participants|||Number
817005|NCT01117623|Other Pre-specified|Tumor Progression in Dose Escalation Cohort|Tumor progression evaluates changes in a tumor or tumors over time due to worsening of disease. Measurements and observations of the tumor status were performed before, during and after treatment. Progression for solid tumors was evaluated based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.0) criteria. Tumor dimensions were measured in millimeters and the longest diameter (LD) was recorded for up to 5 lesions per organ and 10 lesions total. A sum of the LD for all target lesions was recorded. The use of a 20% increase in the sum of LD of target lesions from the smallest sum or appearance of a new lesion was assessed as progression of disease.|From the screening visit of the first participant until the last evaluation of the final participant over 6 years later, assessed at the screening visit, end of cycle 2, end of each even cycle and during the final visit (end of treatment)|Intent-to-treat (ITT) efficacy analysis (set)||Participants|||Number
817006|NCT01117623|Secondary|Biomarker Soluble Vascular Endothelial Growth Factor Receptor 2 (sCEGFR-2) Plasma Levels|The analysis of Biomarker sCEGFR-2 plasma levels is not done.|No data obtained|ITT|||||
817007|NCT01117623|Secondary|Biomarker Vascular Endothelial Growth Factor (VEGF) Plasma Levels|The analysis of Biomarker VEGF plasma levels is not done|No data obtained|ITT|||||
817008|NCT01117623|Secondary|Ratio of AUCt,ss/AUC (RLIN)|RLIN is the ratio of the measure of systemic drug exposure at steady state to the measure of systemic drug exposure after single dose administration. It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content.|Blood samples were collected on Cycle 1, Day 1 and Cycle 2, Day 1. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10 and 24h post-dose|PK population; Number of Participants with an evaluable AUCt,ss and AUC in at least one analyte were 0 in 20mg; 3 (regorafenib) and 4 (M2) in 40mg; 3 in 100 mg; 2 (regorafenib) and 0 (M2) in 120 mg; 3 (regorafenib) and 2 (M2) in 140 mg; 0 in HCC Child Pugh A; 1 in HCC Child Pugh B; 4 in NSCLC; No participants have evaluable data for M5.||Ratio|||Number
817009|NCT01117623|Secondary|Ratio of AUCt,ss/AUCt (RAAUC)|RAAUC is the ratio of the measure of systemic drug exposure over a specific dosing interval at steady state to the measure of systemic drug exposure over a specific dosing interval after single dose administration. It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content.|Blood samples were collected on Cycle 1, Day 1 and Cycle 2, Day 1 and on Cycle 3, Day 1 for expansion cohort. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10 and 24h post-dose|Pharmacokinetic population; Number of Participants with an evaluable AUCt,ss and AUCt in at least one analyte were 0 (M5) in 20mg; 5 (regorafenib and M2) and 4 (M5) in 40mg; 6 in 100 mg; 2 in 120 mg; 3 in 140 mg; 0 in HCC Child Pugh A; 1 in HCC Child Pugh B; 5 in NSCLC||Ratio|||Number
817010|NCT01117623|Secondary|Ratio of Cmin,ss/Cmin (RACmin)|RACmin is the ratio of the lowest drug concentration at steady state to the lowest drug concentration after single dose administration. It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content.|Blood samples were collected on Cycle 1, Day 1 and Cycle 2, Day 1 and on Cycle 3, Day 1 for expansion cohort. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10 and 24h post-dose|Pharmacokinetic population; Number of Participants with an evaluable Cmin,ss and Cmin in at least one analyte were 0 (M5) in 20mg; 6 (regorafenib and M2) and 4 (M5) in 40mg; 6 in 100 mg; 2 in 120 mg; 3 in 140 mg; 0 in HCC Child Pugh A; 1 in HCC Child Pugh B; 5 in NSCLC||Ratio|||Number
817011|NCT01117623|Secondary|Ratio of Cmax,ss/Cmax (RACmax)|RACmax is the ratio of the highest drug concentration at steady state to the highest drug concentration after single dose administration. It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content.|Blood samples were collected on Cycle 1, Day 1 and Cycle 2, Day 1 and on Cycle 3, Day 1 for expansion cohort. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10 and 24h post-dose|Pharmacokinetic population; Number of Participants with an evaluable Cmax,ss and Cmax in at least one analyte were 1 (M5) in 20mg; 5 (regorafenib and M2) and 4 (M5) in 40mg; 6 in 100 mg; 2 in 120 mg; 3 in 140 mg; 0 in HCC Child Pugh A; 1 in HCC Child Pugh B; 5 in NSCLC||Ratio|||Number
817057|NCT01119222|Primary|Interpolated Average Pain (0-8 Hours)|Interpolated average pain (0 to 8 hours): area under the curve (AUC) of average pain (0 to 120 seconds) recorded at each of the time points taken over 8 hour time period divided by 8.|Pre-dose to 8 hours post-dose|Participants for analysis = participants who completed all of the four treatment periods.||hours||Standard Error|Least Squares Mean
817117|NCT01119755|Primary|Mean Difference of Diastolic Daytime Ambulatory Blood Pressure Between Summer and Winter|Mean Difference of Diastolic Daytime Ambulatory Blood Pressure Measurement During Summer and Winter Period|1 year|||mmHg||Standard Deviation|Mean
817013|NCT01117623|Secondary|AUC From Time 0 to 24 Hours at Steady State Divided by Dose (AUC(0-24)ss/D)|AUC(0-24)ss/D is a measure of systemic drug exposure (AUC) over 24 hours after multiple dose administration and after a steady state concentration has been reached, which is then divided by the administered dose. It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content.|Blood samples were collected on Cycle 2, Day 1 and on Cycle 3, Day 1 for expansion cohort. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10 and 24h post-dose|Pharmacokinetic population; Number of Participants with an evaluable AUC(0-24)ss/D in at least one analyte were 6 in 40mg; 6 in 100 mg; 2 in 120 mg; 3 in 140 mg; 0 in HCC Child Pugh A; 1 in HCC Child Pugh B; 5 in NSCLC||h/L||Geometric Coefficient of Variation|Geometric Mean
817014|NCT01117623|Secondary|Cmax at Steady State During a Dosing Interval Divided by Dose (Cmax,ss/D)|Cmax,ss/D refers to the highest measured drug concentration after multiple dose administration and after a steady state concentration has been reached, which is then divided by the administered dose. It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content.|Blood samples were collected at on Cycle 2, Day 1 and on Cycle 3, Day 1 for expansion cohort. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10 and 24h post-dose|Pharmacokinetic population; Number of Participants with an evaluable Cmax,ss/D in at least one analyte were 6 in 40mg; 6 in 100 mg; 2 in 120 mg; 3 in 140 mg; 0 in HCC Child Pugh A; 1 in HCC Child Pugh B; 5 in NSCLC||1/L||Geometric Coefficient of Variation|Geometric Mean
817015|NCT01117623|Secondary|Half-life Associated With the Terminal Slope (T1/2)|T1/2 is the period of time required for the concentration or amount of drug in the body to be reduced to exactly one-half of a given concentration or amount. It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content.|Blood samples were collected on Cycle 1, Day 1. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10, 24, and 48 h post-dose.|PK population; Number of Patients with at least an evaluable T1/2 were 5 (regorafenib) and 6 (M2) in 40mg; 5 (regorafenib and M2) in 100 mg; 3 (regorafenib and M2) in 120 mg; 6 (regorafenib and M2) in 140 mg; 9 (regorafenib), 10(M2) and 1 (M5) in HCC Child Pugh A; 3 (regorafenib) and 2 (M2) in HCC Child Pugh B; 19 (regorafenib) and 16 (M2) in NSCLC||h||Geometric Coefficient of Variation|Geometric Mean
817016|NCT01117623|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)|Tmax refers to the time after dosing when a drug attains its highest measurable concentration (Cmax). It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content.|Blood samples were collected on Cycle 1, Day 1. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10, 24, and 48 h post-dose.|Pharmacokinetic population; Number of Participants with an evaluable Tmax in at least one analyte were 1 (M-5) in 20 mg; 5 (M-5) in 40mg; 13 (M-5) in HCC Child Pugh A; 22 (M-5) in NSCLC||h||Full Range|Median
817017|NCT01117623|Secondary|Maximum Observed Plasma Concentration After Single Dose Administration Divided by Dose (Cmax/D)|Cmax/D refers to the highest measured drug concentration after a single dose administration, which is then divided by the administered dose. It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content.|Blood samples were collected on Cycle 1, Day 1. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10, 24, and 48 h post-dose|Pharmacokinetic population; Number of Participants with an evaluable Cmax/D in at least one analyte was 1 (M5) in 20mg; 7 (regorafenib and M2) and 5 (M5) in 40mg; 13 (M5) in HCC Child-Pugh A; 22 (M5) in NSCLC||1/L||Geometric Coefficient of Variation|Geometric Mean
817018|NCT01117623|Secondary|Area Under the Concentration vs. Time Curve From Zero to Infinity After Single (First) Dose Divided by Dose (AUC/D)|The AUC/D is a measure of systemic drug exposure (AUC) after the first single dose, which is then divided by that dose. It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content.|Blood samples were collected on Cycle 1, Day 1. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10, 24, and 48 h post-dose|PK population; Number of Participants with at least one evaluable AUC/D were 5 (regorafenib) and 6 (M-2) in 40mg; 5 (regorafenib and M-2) in 100 mg; 3 (M-2) in 120 mg; 6 (regorafenib and M-2) in 140 mg; 9 (regorafenib), 10 (M-2) and 1 (M5) in HCC Child Pugh A; 3 (regorafenib) and 2 (M-2) in HCC Child Pugh B; 19 (regorafenib) and 16 (M-2) in NSCLC||h/L||Geometric Coefficient of Variation|Geometric Mean
817019|NCT01117623|Secondary|AUC From Time 0 to the Last Data Point > Lower Limit of Quantification (LLOQ) (AUC(0-tlast))|The AUC(0-tlast) is a measure of systemic drug exposure from time 0 up to the time point at which the last measurable drug could be detectable, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.|Blood samples were collected on Cycle 1, Day 1. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10, 24, and 48 h post-dose|Pharmacokinetic population; Number of Participants with an evaluable AUC(0-tlast) in at least one analyte were 1(M-5) in 20mg; 7 (regorafenib and M-2) and 5 (M-5) in 40mg; 13 (M-5) in HCC Child Pugh A; 22 (M5) in NSCLC||mg*h/L||Geometric Coefficient of Variation|Geometric Mean
817020|NCT01117623|Primary|AUC From Time 0 to 24 Hours at Steady State(AUC(0-24),ss)|AUC(0-24),ss is a measure of systemic drug exposure over 24 hours, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample, after multiple dose administration and after a steady state concentration has been reached.|Blood samples were collected on Cycle 2, Day 1 and on Cycle 3, Day 1 for expansion cohort. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10 and 24h post-dose.|Pharmacokinetic population; Number of Participants with an evaluable AUC(0-24),ss in at least one analyte in at least one analyte were 6 in 40mg; 6 in 100 mg; 2 in 120 mg; 3 in 140 mg; 0 in HCC Child Pugh A; 1 in HCC Child Pugh B; 5 in NSCLC||mg*h/mL||Geometric Coefficient of Variation|Geometric Mean
817021|NCT01117623|Primary|Cmax at Steady State During a Dosing Interval (Cmax,ss)|Cmax,ss refers to the highest measured drug concentration, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample, after multiple dose administration and after a steady state concentration has been reached.|Blood samples were collected at on Cycle 2, Day 1 and on Cycle 3, Day 1 for expansion cohort. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10 and 24h post-dose.|Pharmacokinetic population; Number of Participants with an evaluable Cmax,ss in at least one analyte were 6 in 40mg; 6 in 100 mg; 2 in 120 mg; 3 in 140 mg; 0 in HCC Child Pugh A; 1 in HCC Child Pugh B; 5 in NSCLC||mg/L||Geometric Coefficient of Variation|Geometric Mean
817022|NCT01117623|Primary|Area Under the Concentration vs. Time Curve From Zero to Infinity After Single (First) Dose (AUC)|The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.|Blood samples were collected on Cycle 1, Day 1. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10, 24, and 48 h post-dose|PK population; Number of Participants with at least one evaluable AUC were 5 (regorafenib) and 6 (M2) in 40mg; 5 (regorafenib and M2) in 100 mg; 3 (M2) in 120 mg; 6 (regorafenib and M2) in 140 mg; 9 (regorafenib), 10 (M2) and 1 (M5) in HCC Child Pugh A; 3 (regorafenib) and 2 (M2) in HCC Child Pugh B; 19 (regorafenib) and 16 (M2) in NSCLC||mg*h/L||Geometric Coefficient of Variation|Geometric Mean
817023|NCT01117623|Primary|Maximum Observed Plasma Concentration After Single Dose Administration (Cmax)|Cmax refers to the highest measured drug concentration, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.|Blood samples were collected on Cycle 1, Day 1. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10, 24, and 48 h post-dose|Pharmacokinetic population; Number of Participants with an evaluable Cmax in at least one analyte was 1 (M5) in 20mg; 7 (regorafenib and M2) and 5 (M5) in 40mg; 13 (M5) in HCC Child-Pugh A; 22 (M5) in NSCLC||mg/L||Geometric Coefficient of Variation|Geometric Mean
817024|NCT01117623|Primary|Maximum Tolerated Dose (MTD)|The MTD was defined as the highest dose level, which could be given to 6 participants such that no more than 1 participant (less than 33%) experienced a dose-limiting toxicity (DLT).|Within first 4 weeks of treatment|Safety Population; dose escalation cohorts only||mg|||Number
817025|NCT01117727|Primary|Accuracy of Using the BCI as a Switch to Select From 4 Targets Using Scanning|Average accuracy for selecting one of 4 targets with a switch operated by a brain-computer interface controlled by power in the sensorimotor rhythms. The 8 sessions were conducted over a 2 month period. Accuracy was calculated as the percentage of trials in which the target was correctly selected. Trials for all sessions were combined to create the overall average. Therefore, there is no standard deviation. .|8 sessions over 2 months|||percent of correct targets selected|||Number
817026|NCT01117766|Secondary|Mean Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Total Score at Visits 4 and 7|NPSI: 10-item self-administered questionnaire assessing 5 dimensions of pain (burning superficial spontaneous pain, pressing deep spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dysesthesia). Each item consists of a question about the specific qualities of pain and an 11-point numerical scale range: 0 (absence of pain) to 10 (maximum intensity imaginable), and 2 temporal items related to spontaneous and paroxysmal pain. Maximum total score possible = 100.|Week 4 (Visits 4 and 7) of each period|FAS. n=18, 18; number of participants contributing to the mean.||scores on a scale||Standard Deviation|Mean
817027|NCT01117766|Secondary|Mean Change From Baseline in Test-Day Global Pain Intensity at Visits 3 and 6 and Visits 4 and 7|Global pain: participant-rated pain using the test-day global pain scale, consisting of an 11-point NRS where 0 = no pain and 10 = worst possible pain. Participants described intensity of pain in response to “How intense is your pain today?”|Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period|FAS. n=number of participants contributing to the mean.||scores on a scale||Standard Deviation|Mean
817028|NCT01117766|Secondary|Mean Change From Baseline in Patient's Global Impression of Change (PGIC) at Visits 3 and 6 and Visits 4 and 7|PGIC: participant-rated assessment measuring change in participant's overall status on a 7-point scale from 1=very much improved to 7=very much worse.|Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period|FAS. n=number of participants contributing to the mean.||scores on a scale||Standard Deviation|Mean
817029|NCT01117766|Secondary|Mean Change From Baseline in Weekly Pain Score From the Daily Diary at Visits 3 and 6 and Visits 4 and 7|Daily pain diary: participant-rated pain during the past 24 hours rated on an 11 point NRS scale where 0=no pain and 10=worst possible pain. For a given week, the pain response was the average of the 7 daily entries for that week, or average of the available data for that week if fewer than 7 entries were recorded (>=1 daily pain score for any given week required). The endpoint for each week consisted of the change from baseline in average pain score (follow-up value minus baseline).|Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period|FAS. n=number of participants contributing to the mean. Missing weeks within a period were imputed using last observation carried forward (LOCF).||scores on a scale||Standard Deviation|Mean
817030|NCT01117766|Primary|Mean Change From Baseline in Heat Pain Sensitivity at Visits 3 and 6 and Visits 4 and 7|Duration of thermal stimuli was 2 seconds and an intensity that is increased in steps of 4 degrees celsius for heat stimuli (between 40 and 50 degrees celsius). Thermal pain sensitivity was participant-rated using 11-point NRS where 0=no pain and 10=worst pain imaginable. The average of 2 ratings was calculated to get the mean score.|Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period|FAS. n=number of participants contributing to the mean. Missing values were imputed using a single imputation regression method.||scores on a scale||Standard Deviation|Mean
817031|NCT01117766|Primary|Mean Change From Baseline in Cold Pain Sensitivity at Visits 3 and 6 and Visits 4 and 7|Duration of thermal stimuli was 2 seconds and an intensity that is increased in steps of 5 degrees celsius for cold stimuli (between 5 and 20 degrees celsius). Thermal pain sensitivity was participant-rated using 11-point NRS where 0=no pain and 10=worst pain imaginable. The average of 2 ratings was calculated to get the mean score.|Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period|FAS. n=number of participants contributing to the mean. Missing values were imputed using a single imputation regression method.||scores on a scale||Standard Deviation|Mean
817032|NCT01117766|Primary|Mean Change From Baseline in Punctate Allodynia Area (Von Frey) at Visits 3 and 6 and Visits 4 and 7|Punctate allodynia area in cm^2: calculated from 8 measured distances by calculating the area of an octagon. The angle between each pair of lines was 45 degrees at point c. The area of the octagon was found by totaling the areas of the 8 triangles. Octagon with 8 radial lengths from center to the outside. Area = Σ ( ½ length * perpendicular height); Σ ( ½ ri * sin(45) r(i+1) ) = Σ ( (ri * r(i+1) )/2√2)). (where ri, i=1 to 8, were the eight radial lengths)|Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period|FAS. n=number of participants contributing to the mean.||cm2||Standard Deviation|Mean
817072|NCT01119443|Secondary|Tmax,ss (Fed Conditions)|Time from dosing to the maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ|Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration|One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set||hour||Full Range|Mean
817033|NCT01117766|Primary|Mean Change From Baseline in Mechanical Pain Sensitivity (Von Frey) at Visits 3 and 6 and Visits 4 and 7|Sensitivity to mechanical pain stimuli was tested using calibrated Von Frey monofilaments. To obtain a stimulus-response-function, seven different Von Frey monofilaments (size 8 to 512 mN, force increased by a factor of two from filament to filament) applied three times each; each stimulus was participant-rated using 11-point NRS where 0=no pain and 10=worst pain imaginable. If a score of 8 or more was reported for a given intensity no stronger stimuli was applied. Von Frey stimulus was applied to the skin for 1 to 2 seconds. The average of 3 ratings was calculated for the mean score.|Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period|FAS. n=number of participants contributing to the mean. Missing values were imputed using a single imputation regression method.||scores on a scale||Standard Deviation|Mean
817034|NCT01117766|Primary|Mean Change From Baseline in Dynamic Allodynia Area at Visits 3 and 6 and Visits 4 and 7|Dynamic area brush in cm^2: calculated from 8 measured distances by calculating the area of an octagon. The angle between each pair of lines was 45 degrees at point c. The area of the octagon was found by totaling the areas of the 8 triangles. Octagon with 8 radial lengths from center to the outside. Area = Σ ( ½ length * perpendicular height); Σ ( ½ ri * sin(45) r(i+1) ) = Σ ( (ri * r(i+1) )/2√2)). (where ri, i=1 to 8, were the eight radial lengths)|Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period|FAS. n=number of participants contributing to the mean.||cm2||Standard Deviation|Mean
817035|NCT01117766|Primary|Mean Change From Baseline in Dynamic Allodynia Intensity at Visits 3 and 6 and Visits 4 and 7|Five strokes applied with a standardized brush (somedic) across the painful site, 6cm long and at a control site to allow the participants to appreciate any difference. A painful and clearly dysaesthetic (unpleasant) sensation was considered as representing brush allodynia (whereas a “strange” or “tickly” sensation provoked by the brush was not). After each brush stimuli participants were asked to give a pain rating using 11-point numerical rating scale (NRS) where 0=no pain and 10=worst pain imaginable. The average of 5 brush strokes was calculated to obtain the mean score.|Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period|Full analysis set (FAS)=participants with present pain intensity score >=4 out of 10 for brush evoked allodynia at screening and randomization, >=4 out of 7 non missing values in week prior to randomization, >4 for weekly average daily pain score, and who did not withdraw/discontinue. n=number of participants contributing to the mean.||scores on a scale||Standard Deviation|Mean
817036|NCT01119001|Primary|Accuracy of Typing With a BCI Keyboard by ALS Patients.|"Accuracy for the sentence typed in each environment was calculated as the percentage of characters for which the result character matched the target character. The target characters were determined based on the next character needed to complete the sentence to be copied. In the case of errors, the next character was therefore a backspace to correct the error. The target characters were modified by subject comments to account for errors in selecting the next character.
Once sentence was typed in each environment in each session on a separate day. From the three repeated sessions, there were therefore 9 total sentences per subject with 3 measures for each environment. These were treated as repeated measures for the analysis."|3 times over 2-4 weeks|||percentage accuracy||Full Range|Mean
817037|NCT01119040|Primary|Number of Participants With Successful Replacements of Dislodged PEG Tubes With NOTES Procedures in Lieu of Traditional Surgical Methods.|Successful replacement will be determined via the number of patients requiring conversion from NOTES PEG rescue to conventional incision-based surgery.|30 day follow-up|Only 1 subject due to low accrual||participants|||Number
817038|NCT01119118|Secondary|Number of Subjects With PSA Response||6 months|||participants|||Number
817039|NCT01119118|Secondary|Number of Subjects Whose Tumor Lesion Size Changed Using Iterative Decomposition of Water and Fat With Echo Asymmetry and Least-squares Estimation (IDEAL)-MRI Imaging Alone||Week 6|||participants|||Number
817040|NCT01119118|Secondary|The Number of Subjects Whose Tumor Lesion Size Changed Using Diffusion-weighted Imaging (DWI)-Magnetic Resonant Imaging (MRI) Alone||Week 6|||participants|||Number
817041|NCT01119118|Secondary|The Number of Subjects Whose Tumor Lesion Size Changed Using Positron Emission Tomography (PET) Imaging Alone.||Week 6|||participants|||Number
817042|NCT01119118|Primary|The Number of Subjects Whose Tumor Lesion Size Changed After 6 Weeks of Treatment With ZD4054 Using PET and MRI Scans.|Multimodal Positron Emission Tomography (PET) and Magnetic Resonant Imaging (MRI) imaging were used to evaluate changes in the tumor lesion size following 6 weeks of treatment with ZD4054.|Week 6|||participants|||Number
817043|NCT01119131|Secondary|Change in Parkinsonism as Measured by the UPDRS|This is the motor subsection of the UPDRS and is a commonly used tool to rate the symptoms of Parkinson‘s disease. This scale rates from 0 (normal) to 4 (Can barely perform the task) several motor areas including speech, facial expression, tremor, rigidity, hand movements, agility, posture, and gait. A sum score represents motor function with higher values on this scale represent a more severe stage of the disease. Change is measurement at 16 weeks minus baseline measurement, negative scores indicate an improvement in Parkinson's motor symptoms.|Baseline, 16 weeks|Missing data (N = 2), invalid sum due to missing rating (N = 1), not completed due to scheduling conflicts (N = 1).||units on a scale||Standard Deviation|Mean
817044|NCT01119131|Primary|Change in Strength as Recorded by Measuring Knee Extension Using Biodex (Total Work)|Defined as the total muscular force output for the repetition with the greatest amount of work. The equation for work is: W = F x D. Change score is measurement at 16 weeks minus measurement at baseline.|Baseline, 16 weeks|Missing data N=4, test not performed due to participant fatigue (N = 2), mechanical/computer issues (N = 1), illness of operator (N = 1).||foot pounds||Standard Deviation|Mean
817045|NCT01119131|Primary|Change in Dynamic Balance as Recorded Using Dynamic Posturography With the Sensory Organization Test (SOT 4-6)|Sensory organization test (SOT) is a form of posturography. which is designed to assess quantitatively an individual`s ability to use visual, proprioceptive and vestibular cues to maintain postural stability in stance. The SOT measures sway during 6 scenarios. In 4-6 the base moves and the subject has eyes open, then closed, then the visual surround moves. SOT 4-6 is an average measurement of equilibrium - the average center of gravity sway for each condition. It generates a score of 0 (fall) up to 100 for each scenario and an overall composite score. Change score is measurement at 16 weeks minus measurement at baseline.|Baseline, 16 weeks|Missing data N=3, test not performed due to participant fatigue (N = 2) or computer/mechanical error (N = 1).||units on a scale||Standard Deviation|Mean
817118|NCT01119755|Secondary|Mean Difference of Systolic Clinic Blood Pressure Between Summer and Winter||1 year|||mmHg||Standard Deviation|Mean
817046|NCT01119131|Secondary|Change in Quality of Life as Recorded Using Quality of Life Scales (PDQ39)|"The PDQ39 is a 39 item patient completed survey targeting well-being and functioning in PD. This scale address 8 dimensions (mobility, activities of daily living, emotional well-being, stigma, social support, cognitions, communication, and bodily discomfort). The PDQ39 dimension scores are on a scale of 0 (Never) to 4 (Always/Cannot Do). Scale scores are summed and range from 0 to 100 with 100 being the maximum level of problems. For a single index figure to characterize the impact of Parkinson’s disease upon PD patients (PDSI), all 39 items of the PDQ39 can be summed. The PDQ39 and the use of a PDSI have shown adequate reliability and convergent validity. Change score is measurement at 16 weeks minus baseline measurement, negative scores indicate an improvement in quality of life."|Baseline, 16 weeks|Missing data (N = 3), patient forgot form and did not return mailed form (N = 3).||units on a scale||Standard Deviation|Mean
817047|NCT01119131|Secondary|Change in Cognition (Trail Making Test B-A)|The Trail Making Test (TMT) consists of two parts (A & B) in which the subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy. The test provides information about visual search speed, scanning, speed of processing, and executive functioning. Part A measures processing speed and part B measures executive functioning. The TMT is time to complete each part of the test in seconds. Higher scores indicate greater impairment. Subtracting part A from part B is theorized to reduce the influence of the working memory and visuospatial demands and, therefore, provides a relatively pure indicator of executive function. Change score is measurement (Part B - Part A) at 16 weeks minus measurement (Part B - Part A) at baseline, negative scores indicate a improvement in executive functioning.|Baseline, 16 weeks|Missing data (N = 8) due to scheduling difficulties (N = 3), neuropsychological administration errors (N = 2), patient discontinuing (N = 1), maximum time allowance met and discontinued test (N = 2).||seconds||Standard Deviation|Mean
817048|NCT01119131|Primary|Change in Strength as Recorded by Measuring Knee Flexion Using Biodex (Total Work)|Defined as the total muscular force output for the repetition with the greatest amount of work. The equation for work is: W = F x D. Change score is measurement at 16 weeks minus measurement at baseline.|Baseline, 16 weeks|Missing data N=4, test not performed due to participant fatigue (N = 2), mechanical/computer issues (N = 1), illness of operator (N = 1).||foot pounds||Standard Deviation|Mean
817049|NCT01119131|Primary|Change in Ambulatory Balance Measured by Instrumented Timed up and go (iTUG) Turn Duration|"This is a test that measures ambulatory balance and mobility. The instrumented timed up and go (iTUG) is an average time (seconds) of three trials that involve the participant arising from a chair, walking 25 feet turning around, walking back to the chair, and sitting down. The turn duration is the average time to turn at the end of the 25 foot walk. Longer duration of time (seconds) indicates more rigidity, a proxy measure for ON time in Parkinson’s disease. Change score is measurement at 16 weeks minus measurement at baseline."|Baseline and 16 weeks|Missing data N=14, test not performed due to either participant fatigue (N = 2) or mechanical/computer issues (N = 12).||seconds||Standard Deviation|Mean
817050|NCT01119131|Primary|Change in Static Balance as Recorded Using Dynamic Posturography With the Sensory Organization Test (SOT 1-3)|Sensory organization test (SOT) is a form of posturography. which is designed to assess quantitatively an individual`s ability to use visual, proprioceptive and vestibular cues to maintain postural stability in stance. The SOT measures sway during 6 scenarios. In scenarios 1-3 the base is stable and eyes are open, then closed, and then the visual surround moves. SOT 1-3 is an average measurement of equilibrium - the average center of gravity sway for each condition. It generates a score of 0 (fall) up to 100 for each scenario and an overall composite score. Change score is measurement at 16 weeks minus measurement at baseline.|Baseline, 16 weeks|Missing data N=2, test not performed due to participant fatigue.||units on a scale||Standard Deviation|Mean
817051|NCT01119222|Secondary|Number of Participants With Abnormal Pulse Oxymetry Results|Pulse oxymetry to monitor percentage of hemoglobin saturated with oxygen during intervenous (IV) infusion dosing (morphine or placebo).|Predose through duration of IV infusion dosing|Safety population: all subjects who received at least 1 dose of study medication. Although pulse oxymetry was performed throughout IV dosing, results were not captured for inclusion in the study database.||participants|||Number
817052|NCT01119222|Secondary|Number of Participants With Abnormal Cardiac Monitoring Results|Continuous cardiac monitoring during intervenous (IV) infusion dosing (morphine or placebo).|Pre-dose through duration of IV infusion dosing|Safety population: all subjects who received at least 1 dose of study medication. Although continuous cardiac monitoring was performed throughout IV dosing, results were not captured for inclusion in the study database.||participants|||Number
817053|NCT01119222|Secondary|Number of Participants With Abnormal Haematology, Clinical Chemistry, Urinalysis Results|Standard haematology, clinical chemistry, and urinalysis safety laboratory tests.|Pre-dose, follow-up visit (at least 7 days after last dosing)|Safety population: all subjects who received at least 1 dose of study medication. Although individual subject data were collected and monitored, summary statistics were not generated for this outcome measure.||particpants|||Number
817054|NCT01119222|Secondary|Number of Participants With Abnormal Findings on Electrocardiogram (ECG)|Standard 12-lead ECG performed after subject had rested quietly for at least 10 minutes in a supine position.|Pre-dose and follow-up visit (at least 7 days after last dosing)|Safety population: all subjects who received at least 1 dose of study medication. Although individual subject data were collected and monitored, summary statistics were not generated for this outcome measure.||participants|||Number
817055|NCT01119222|Secondary|Number of Participants With Clinically Significant Abnormal Findings on Physical Examination|Full physical examination consisting of an examination of the abdomen, cardiovascular systems, lungs, lymph nodes, mouth, musculoskeletal and neurological systems, skin, extremities, head, ears, eyes, nose, throat and thyroid gland.|Pre-dose and follow-up visit (at least 7 days after last dosing)|Safety population: all subjects who received at least 1 dose of study medication. Although individual subject data were collected, results were not captured for inclusion in the study database.||participants|||Number
817056|NCT01119222|Secondary|Number of Participants With Clinically Significant Findings in Vital Signs|Supine blood pressure measured to nearest millimeter of mercury (mmHg), pulse rate measured with automated device or manually in the brachial/radial artery for at least 30 seconds.|Predose, Day 1, Day 2 each treatment period, follow-up visit (at least 7 days after last dosing)|Safety population: all subjects who received at least 1 dose of study medication. Although individual listing data for vital signs were collected, summary statistics were not generated for this outcome measure.||participants|||Number
817058|NCT01119222|Primary|Average Pain (0-120 Seconds): Cold Pain Test Visual Analog Scale (VAS)|"Area under the cold pain test Visual Analog Scale (VAS) time curve (AUCcpt 0 to 120 seconds [sec]) averaged over the 120 sec for each time point assessed. Participant adjusted 100 millimeter (mm) electronic VAS with range of no pain (0) to maximum pain (100) at the anchor endpoints of the scale and moderate pain at the midpoint. Pain reported while non-dominant hand was placed in thermostatically controlled water bath at 2±1°C for a maximum of 120 sec."|Pre-dose, 1, 1.5, 2, 4, and 8 hours post-dose|Participants for analysis = participants who completed all of the four treatment periods.||mm||Standard Deviation|Mean
817059|NCT01119287|Primary|Mean Change From Baseline Patient-Assessed Ocular Itching, Area Under the Curve From Time Zero to Hour 3 [AUC (0-3)], Patanol and Placebo|Ocular itching was scored a scale from 0 (none) to 4 (incapacitating itch with irresistible urge to rub) in 0.5 unit steps. The AUC computation was based on the score at each time point (pre-treatment, 0.25, 0.5, 1.0, 1.5, 2.0, 2.5, and 3 hours in the EEC). The patient was dosed AM 30 minutes prior to entering the EEC (Visit 5). This outcome measure evaluates an early-phase effect, for which Patanol vs. Placebo is the meaningful comparison.|Baseline (Visit 2, pre-treatment), Visit 5 (Day 8 of treatment)|Number of subjects with data available in the specific treatment group||hours x units on a scale||Standard Deviation|Mean
817060|NCT01119287|Primary|Mean Change From Baseline in Staff-Assessed Ocular Redness, Area Under the Curve From Time Zero to Hour 10 [AUC (0-10)], Maxidex and Placebo|Ocular redness ratings were collected for nasal and temporal areas of each eye and scored on a scale from 0 (none) to 4 (extremely severe), 0.5 unit steps permitted. The AUC computation was based on peak redness score (maximum of four areas of redness) at each time point (pre-treatment, 0.25, 0.5, 1.0, 1.5, 2.0, 2.5, 3 hours in the EEC and 3.5, 4, 5, 6, 7, 8, 9, 10 hours in the Clinic). The patient was dosed AM 30 minutes prior to entering the EEC (Visit 6). This outcome measure evaluates a late-phase effect, for which Maxidex vs. Placebo is the meaningful comparison.|Baseline (Visit 3, pre-treatment); Visit 6 (Day 9 of treatment)|Number of subjects with data available in the specific treatment group||hours x units on a scale||Standard Deviation|Mean
817061|NCT01119443|Secondary|MRTpo,ss (Fasted Conditions)|Mean residence time of the analyte in the body at steady state after oral administration|Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration|One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set||hour||Standard Deviation|Geometric Mean
817062|NCT01119443|Secondary|t1/2,ss (Fasted Conditions)|Terminal half-life of the analyte in plasma at steady state|Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration|One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set||hour||Standard Deviation|Geometric Mean
817063|NCT01119443|Secondary|λz,ss (Fasted Conditions)|Terminal rate constant of the analyte in plasma at steady state|Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration|One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set||/hour||Standard Deviation|Geometric Mean
817064|NCT01119443|Secondary|Tmax,ss (Fasted Conditions)|Time from dosing to the maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ|Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration|One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set||hour||Full Range|Mean
817065|NCT01119443|Secondary|Cmin,ss (Fasted Conditions)|Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ|Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration|One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set||ng/mL||Standard Deviation|Geometric Mean
817066|NCT01119443|Secondary|Cτ,ss (Fasted Conditions)|Concentration of the analyte in plasma at time τ at steady state|pharmacokinetic blood samples collected at τ (23.833 hours) after drug administration|One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set||ng/mL||Standard Error|Geometric Mean
817067|NCT01119443|Primary|Cmax,ss (Fasted Conditions)|maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ|Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration|One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set||ng/mL||Standard Deviation|Geometric Mean
817068|NCT01119443|Primary|AUCτ,ss (Fasted Conditions)|Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ|Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration|One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set||ng/mL||Standard Deviation|Geometric Mean
817069|NCT01119443|Secondary|MRTpo,ss (Fed Conditions)|Mean residence time of the analyte in the body at steady state after oral administration|Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration|One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set||hour||Standard Deviation|Geometric Mean
817070|NCT01119443|Secondary|t1/2,ss (Fed Conditions)|Terminal half-life of the analyte in plasma at steady state|Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration|One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set||hour||Standard Deviation|Geometric Mean
817071|NCT01119443|Secondary|λz,ss (Fed Conditions)|Terminal rate constant of the analyte in plasma at steady state|Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration|One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set||per hour||Standard Deviation|Geometric Mean
817074|NCT01119443|Secondary|Cτ,ss (Fed Conditions)|Concentration of the analyte in plasma at time τ at steady state|pharmacokinetic blood samples collected at τ (23.833 hours) after drug administration|One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set||ng/mL||Standard Error|Geometric Mean
817075|NCT01119443|Primary|Cmax,ss (Fed Conditions)|maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ|Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration|One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set||ng/mL||Standard Deviation|Geometric Mean
817076|NCT01119443|Primary|AUCτ,ss (Fed Conditions)|Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ|Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration|One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set||ng·h/mL||Standard Deviation|Geometric Mean
817077|NCT01119625|Secondary|Titers of Antibodies Against Poliovirus Types 1, 2 and 3.|Titers were expresses as geometric mean titers (GMTs). The cut-off of the assay was 8.|Before and one month after booster vaccination (at Month 0 and Month 1)|The ATP cohort for immunogenicity included evaluable subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after booster vaccination.||Titers||95% Confidence Interval|Geometric Mean
817078|NCT01119625|Secondary|Concentrations of Antibodies Against Polyribosyl-ribitol Phosphate (PRP).|Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL). The cut-off of the assay was 0.15 µg/mL.|Before and one month after booster vaccination (at Month 0 and Month 1)|The ATP cohort for immunogenicity included evaluable subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after booster vaccination.||µg/mL||95% Confidence Interval|Geometric Mean
817079|NCT01119625|Secondary|Concentrations of Antibodies Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN).|Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA units per millilitre (EU/mL). The cut-off of the assay was 5 EU/mL.|Before and one month after booster vaccination (at Month 0 and Month 1)|The ATP cohort for immunogenicity included evaluable subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after booster vaccination.||EU/mL||95% Confidence Interval|Geometric Mean
817080|NCT01119625|Secondary|Concentrations of Antibodies Against Diphtheria and Tetanus.|Concentrations were expressed as geometric mean concentrations (GMCs) in International units per millilitre (IU/mL). The cut-off of the assay was 0.1 IU/mL.|Before and one month after booster vaccination (at Month 0 and Month 1)|The ATP cohort for immunogenicity included evaluable subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after booster vaccination.||IU/mL||95% Confidence Interval|Geometric Mean
817081|NCT01119625|Secondary|Concentrations of Antibodies Against Protein D (PD).|Anti-PD antibodies were determined using an ELISA assay. Concentration of specific PD antibodies was determined, using a standard reference serum. The cut-off of the assay is 100 ELISA units per millilitre (EU/mL).|Before and one month after booster vaccination (at Month 0 and Month 1)|The ATP cohort for immunogenicity included evaluable subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after booster vaccination.||EU/mL||95% Confidence Interval|Geometric Mean
817082|NCT01119625|Secondary|Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes.|"Cross-reactive pneumococcal serotypes assessed were serotypes 6A and 19A. Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL).
The antibody concentrations against the cross-reactive pneumococcal serotypes 6A and 19A were determined by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 0.05 µg/mL."|Before and one month after booster vaccination (at Month 0 and Month 1)|The ATP cohort for immunogenicity included evaluable subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after booster vaccination.||µg/mL||95% Confidence Interval|Geometric Mean
817083|NCT01119625|Secondary|Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.|"Vaccine pneumococcal serotypes assessed were serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL).
Pneumococcal serotype specific total imunoglobuline G (IgG) antibodies were measured by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 0.05 µg/mL."|Before and one month after booster vaccination (at Month 0 and Month 1)|The ATP cohort for immunogenicity included evaluable subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after booster vaccination.||µg/mL||95% Confidence Interval|Geometric Mean
817084|NCT01119625|Secondary|Titers of Antibodies Against Poliovirus Types 1, 2 and 3.|Titers were expresses as geometric mean titers (GMTs). The cut-off of the assay was 8.|Before booster vaccination at Month 0|The analysis was performed on the According-To-Protocol cohort for analysis of antibody persistence which included subjects primed in the primary study (NCT00808444) and for whom assay results were available for antibodies against at least 1 vaccine antigen component for the blood sampling taken before the administration of the booster dose.||Titers||95% Confidence Interval|Geometric Mean
817085|NCT01119625|Secondary|Concentrations of Antibodies Against Polyribosyl-ribitol Phosphate (PRP).|Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL). The cut-off of the assay was 0.15 µg/mL.|Before booster vaccination at Month 0|The analysis was performed on the According-To-Protocol cohort for analysis of antibody persistence which included subjects primed in the primary study (NCT00808444) and for whom assay results were available for antibodies against at least 1 vaccine antigen component for the blood sampling taken before the administration of the booster dose.||µg/mL||95% Confidence Interval|Geometric Mean
817119|NCT01119755|Primary|Mean Difference of Systolic Daytime Ambulatory Blood Pressure Between Summer and Winter.|Mean difference of systolic daytime ambulatory blood pressure measurement during summer and winter period|1 year|||mmHg||Standard Deviation|Mean
818740|NCT01121900|Secondary|Area Under the Plasma Concentration vs. Time Data Pairs, for the First 24 Hours [AUC(0-24)]||24 hours|The dataset for pharmacokinetic analysis comprised the 23 subjects who completed the study as per protocol.||h*ng/mL||Standard Deviation|Mean
817086|NCT01119625|Secondary|Concentrations of Antibodies Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN).|Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA units per millilitre (EU/mL). The cut-off of the assay was 5 EU/mL.|Before booster vaccination at Month 0|The analysis was performed on the According-To-Protocol cohort for analysis of antibody persistence which included subjects primed in the primary study (NCT00808444) and for whom assay results were available for antibodies against at least 1 vaccine antigen component for the blood sampling taken before the administration of the booster dose.||EU/mL||95% Confidence Interval|Geometric Mean
817087|NCT01119625|Secondary|Concentrations of Antibodies Against Diphtheria and Tetanus.|Concentrations were expressed as geometric mean concentrations (GMCs) in International units per millilitre (IU/mL). The cut-off of the assay was 0.1 IU/mL.|Before booster vaccination at Month 0|The analysis was performed on the According-To-Protocol cohort for analysis of antibody persistence which included subjects primed in the primary study (NCT00808444) and for whom assay results were available for antibodies against at least 1 vaccine antigen component for the blood sampling taken before the administration of the booster dose.||IU/mL||95% Confidence Interval|Geometric Mean
817088|NCT01119625|Secondary|Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes.|"Cross-reactive pneumococcal serotypes assessed were serotypes 6A and 19A. Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL).
The antibody concentrations against the cross-reactive pneumococcal serotypes 6A and 19A were determined by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 0.05 µg/mL."|Before booster vaccination at Month 0|The analysis was performed on the According-To-Protocol cohort for analysis of antibody persistence which included subjects primed in the primary study (NCT00808444) and for whom assay results were available for antibodies against at least 1 vaccine antigen component for the blood sampling taken before the administration of the booster dose.||µg/mL||95% Confidence Interval|Geometric Mean
817089|NCT01119625|Secondary|Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A.|Opsonophagocytic activity (OPA) testing was not performed.|Before and one month after booster vaccination (at Month 0 and Month 1)||12/2099||||
817090|NCT01119625|Secondary|Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes.|Opsonophagocytic activity (OPA) testing was not performed.|Before and one month after booster vaccination (at Month 0 and Month 1)||12/2099||||
817091|NCT01119625|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|During the entire study period, from the booster vaccination, at Month 0, up to the study end, at Month 1|The analysis of safety was performed on the Total vaccinated cohort which included all subjects with booster dose administration documented.||Subjects|||Number
817092|NCT01119625|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs).|Unsolicited AEs = Any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study. Also any “solicited” symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.|Within 31 days (Days 0-30) after booster vaccination|The analysis of safety was performed on the Total vaccinated cohort which included all subjects with booster dose administration documented.||Subjects|||Number
817093|NCT01119625|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs).|"Solicited general symptoms assessed were drowsiness, irritability, loss of appetite and fever (= axillary temperature equal to or above 37.5 degrees Celsius (°C)).
Any= occurrence of any general symptom regardless of intensity grade or relationship to vaccination Grade 3 drowsiness = drowsiness which prevented normal activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = temperature >39.5°C.
Related = solicited symptom assessed by the investigator as causally related to study vaccination."|Within 4 days (Days 0-3) after booster vaccination.|The analysis of safety was performed on the Total vaccinated cohort which included all subjects with booster dose administration documented. The analysis of the solicited symptoms based on the Total Vaccinated cohort included subjects with documented safety data.||Subjects|||Number
817094|NCT01119625|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs).|"Solicited AEs = AEs to be recorded as endpoints in the clinical study. The presence/occurrence/intensity of these events is actively solicited from the subject or an observer during a specified post-vaccination follow-up period.
Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimetre (mm)."|Within 4 days (Days 0-3) after booster vaccination.|The analysis of safety was performed on the Total vaccinated cohort which included all subjects with booster dose administration documented. The analysis of the solicited symptoms based on the Total Vaccinated cohort included subjects with documented safety data.||Subjects|||Number
817095|NCT01119625|Primary|Concentrations of Antibodies Against Protein D (PD).|Anti-PD antibodies were determined using an ELISA assay. Concentration of specific PD antibodies was determined, using a standard reference serum. The cut-off of the assay is 100 ELISA units per millilitre (EU/mL).|Before booster vaccination at Month 0|The analysis was performed on the According-To-Protocol cohort for analysis of antibody persistence which included subjects primed in the primary study (NCT00808444) and for whom assay results were available for antibodies against at least 1 vaccine antigen component for the blood sampling taken before the administration of the booster dose.||EU/mL||95% Confidence Interval|Geometric Mean
817120|NCT01119768|Secondary|Symptom Control Rate at 16 Weeks Assessed by Gerd Q Questionnaire|GerdQ Scores ranging from 0 to 3 were applied for the positive predictors and from 3 to 0 (reversed order, where 3 = none) for negative predictors. The GerdQ score was calculated as the sum of these scores, giving a total score ranging from 0 to 18. When GerdQ ≥8, the patients could be symptom based diagnosed as GERD. GerdQ was consisted of 3 categories: A, B and C. Each category has two questions with sum of score ranging from 0 to 6. Symptom controlled was defined as patients with all items ≤1 in A and C category of GerdQ.|16 weeks|MITT was defined as patients in ITT population with symptom relief after 8 weeks or 2 weeks esomeprazole treatment.||percentage of participants|||Number
817096|NCT01119625|Primary|Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.|"Vaccine pneumococcal serotypes assessed were serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL).
Pneumococcal serotype specific total imunoglobuline G (IgG) antibodies were measured by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 0.05 µg/mL."|Before booster vaccination at Month 0|The analysis was performed on the According-To-Protocol cohort for analysis of antibody persistence which included subjects primed in the primary study (NCT00808444) and for whom assay results were available for antibodies against at least 1 vaccine antigen component for the blood sampling taken before the administration of the booster dose.||µg/mL||95% Confidence Interval|Geometric Mean
817097|NCT01119703|Secondary|Antibody Titer Responses to Oral Cholera Vaccine (WC/rBS), Measured and Predicted Based on Early Post-vaccination Biomarkers in Healthy, Elderly Participants.|"Healthy elderly participants were simultaneously vaccinated at baseline with hepatitis vaccine, tetanus-diphtheria booster vaccine, and cholera vaccine. Antibody titers to cholera were then measured 3 weeks after final vaccination, based on ELISA, and are defined as standardized international units of reactivity converted from optical densities, transformed to natural log (ln). In order to predict antibody responses blood samples were collected 7 days post-baseline vaccination to measure a wide variety of biomarkers by mRNA profiling, biochemical and flow cytometric assays. These biomarkers were then used in a machine-learning (random-forest based) model to predict antibody titers, transformed to natural log(ln)."|Day 7 and 3 weeks after final vaccination|Healthy participants 65 years of age and older who were treated with all three vaccines, and had their post-vaccination titers measured. Results from comparing titers and biomarker responses between younger and older cohorts are exploratory, and therefore not reported.||ln International Units||Standard Deviation|Mean
817098|NCT01119703|Secondary|Antibody Titer Responses to Reduced Diphtheria Toxin Vaccine, Measured and Predicted Based on Early Post-vaccination Biomarkers in Healthy, Elderly Participants.|"Healthy elderly participants were simultaneously vaccinated at baseline with hepatitis vaccine, tetanus-diphtheria booster vaccine, and cholera vaccine. Antibody titers to diphtheria were then measured 1 month after final vaccination, based on ELISA, and are defined as standardized international units of reactivity converted from optical densities, transformed to natural log (ln). In order to predict antibody responses blood samples were collected 7 days post-baseline vaccination to measure a wide variety of biomarkers by mRNA profiling, biochemical and flow cytometric assays. These biomarkers were then used in a machine-learning (random-forest based) model to predict antibody titers, transformed to natural log(ln)."|Day 7 and 1 month after final vaccination|Healthy participants 65 years of age and older who were treated with all three vaccines, and had their post-vaccination titers measured. Results from comparing titers and biomarker responses between younger and older cohorts are exploratory, and therefore not reported.||ln International Units||Standard Deviation|Mean
817099|NCT01119703|Secondary|Antibody Titer Responses to Tetanus Booster Vaccine, Measured and Predicted Based on Early Post-vaccination Biomarkers in Healthy, Elderly Participants.|"Healthy elderly participants were simultaneously vaccinated at baseline with hepatitis vaccine, tetanus-diphtheria booster vaccine, and cholera vaccine. Antibody titers to tetanus were then measured 1 month after final vaccination, based on ELISA, and are defined as standardized international units of reactivity converted from optical densities, transformed to natural log (ln). In order to predict antibody responses blood samples were collected 7 days post-baseline vaccination to measure a wide variety of biomarkers by mRNA profiling, biochemical and flow cytometric assays. These biomarkers were then used in a machine-learning (random-forest based) model to predict antibody titers, transformed to natural log(ln)."|Day 7 and 1 month after each final vaccination|Healthy participants 65 years of age and older who were treated with all three vaccines, and had their post-vaccination titers measured. Results from comparing titers and biomarker responses between younger and older cohorts are exploratory, and therefore not reported.||ln International Units||Standard Deviation|Mean
817100|NCT01119703|Secondary|Antibody Titer Responses to Hepatitis B Virus Surface Antigen (HBV sAg) Vaccine, Measured and Predicted Based on Early Post-vaccination Biomarkers in Healthy, Elderly Participants.|"Healthy elderly participants were simultaneously vaccinated at baseline with hepatitis vaccine, tetanus-diphtheria booster vaccine, and cholera vaccine. Antibody titers to HBV sAg were then measured 1 month after final vaccination, based on ELISA, and are defined as standardized international units of reactivity converted from optical densities, transformed to natural log (ln). In order to predict antibody responses blood samples were collected at 7 days post-baseline vaccination to measure a wide variety of biomarkers by mRNA profiling, biochemical and flow cytometric assays. These biomarkers were then used in a machine-learning (random-forest based) model to predict antibody titers, transformed to natural log (ln)."|Day 7 and 1 month after final vaccination|Healthy participants 65 years of age and older who were treated with all three vaccines, and had their post-vaccination titers measured. Results from comparing titers and biomarker responses between younger and older cohorts are exploratory, and therefore not reported.||ln International Units||Standard Deviation|Mean
817101|NCT01119703|Primary|Post-vaccination Antibody Titer Responses to Different Vaccines in Healthy, Elderly, Participants.|"Healthy elderly participants were simultaneously vaccinated at baseline with hepatitis vaccine, tetanus-diphtheria booster vaccine, and cholera vaccine. Antibody titers to each of these four antigens were then measured 1 month after each final vaccination (3 weeks for cholera toxin), based on ELISA, and are defined as standardized international units of reactivity converted from optical densities, transformed to natural log (ln)."|3 weeks or 1 month after each final vaccination|Healthy participants 65 years of age and older who were treated with all three vaccines, and had their post-vaccination titers measured. Results from comparing titers and biomarker responses between younger and older cohorts are exploratory, and therefore not reported.||ln International Units||Standard Deviation|Mean
817121|NCT01119768|Secondary|Symptom Control Rate at 8 Weeks Assessed by Gerd Q Questionnaire|GerdQ Scores ranging from 0 to 3 were applied for the positive predictors and from 3 to 0 (reversed order, where 3 = none) for negative predictors. The GerdQ score was calculated as the sum of these scores, giving a total score ranging from 0 to 18. When GerdQ ≥8, the patients could be symptom based diagnosed as GERD. GerdQ was consisted of 3 categories: A, B and C. Each category has two questions with sum of score ranging from 0 to 6. Symptom controlled was defined as patients with all items ≤1 in A and C category of GerdQ.|8 weeks|Modified Intension To Treat defined as patients in ITT population with symptom relief after 8 weeks or 2 weeks esomeprazole treatment||percentage of participants|||Number
817102|NCT01119703|Primary|Antibody Titer Responses to Oral Cholera Vaccine (WC/rBS), Measured and Predicted Based on Pre-vaccination Biomarkers in Healthy, Elderly Participants.|"Healthy elderly participants were simultaneously vaccinated at baseline with hepatitis vaccine, tetanus-diphtheria booster vaccine, and cholera vaccine. Antibody titers to cholera were then measured 3 weeks after final vaccination, based on ELISA, and are defined as standardized international units of reactivity converted from optical densities, transformed to natural log (ln). In order to predict antibody responses blood samples were collected prior to vaccination at baseline, to measure a wide variety of biomarkers by mRNA profiling, biochemical and flow cytometric assays. These biomarkers were then used in a machine-learning (random-forest based) model to predict antibody titers, transformed to natural log (ln)."|Baseline and 3 weeks after final vaccination|Healthy participants 65 years of age and older who were treated with all three vaccines, and had their post-vaccination titers measured. Results from comparing titers and biomarker responses between younger and older cohorts are exploratory, and therefore not reported.||ln International Units||Standard Deviation|Mean
817103|NCT01119703|Primary|Antibody Titer Responses to Reduced Diphtheria Toxin Vaccine, Measured and Predicted Based on Pre-vaccination Biomarkers in Healthy, Elderly Participants.|"Healthy elderly participants were simultaneously vaccinated at baseline with hepatitis vaccine, tetanus-diphtheria booster vaccine, and cholera vaccine. Antibody titers to diphtheria were then measured 1 month after final vaccination, based on ELISA, and are defined as standardized international units of reactivity converted from optical densities, transformed to natural log (ln). In order to predict antibody responses blood samples were collected prior to vaccination at baseline, to measure a wide variety of biomarkers by mRNA profiling, biochemical and flow cytometric assays. These biomarkers were then used in a machine-learning (random-forest based) model to predict antibody titers, transformed to natural log (ln)."|Baseline and 1 month after final vaccination|Healthy participants 65 years of age and older who were treated with all three vaccines, and had their post-vaccination titers measured. Results from comparing titers and biomarker responses between younger and older cohorts are exploratory, and therefore not reported.||ln International Units||Standard Deviation|Mean
817104|NCT01119703|Primary|Antibody Titer Responses to Tetanus Booster Vaccine, Measured and Predicted Based on Pre-vaccination Biomarkers in Healthy, Elderly Participants.|"Healthy elderly participants were simultaneously vaccinated at baseline with hepatitis vaccine, tetanus-diphtheria booster vaccine, and cholera vaccine. Antibody titers to tetanus were then measured 1 month after final vaccination, based on ELISA, and are defined as standardized international units of reactivity converted from optical densities, transformed to natural log (ln). In order to predict antibody responses blood samples were collected prior to vaccination at baseline, to measure a wide variety of biomarkers by mRNA profiling, biochemical and flow cytometric assays. These biomarkers were then used in a machine-learning (random-forest based) model to predict antibody titers, transformed to natural log (ln)."|Baseline and 1 month after final vaccination|Healthy participants 65 years of age and older who were treated with all three vaccines, and had their post-vaccination titers measured. Results from comparing titers and biomarker responses between younger and older cohorts are exploratory, and therefore not reported.||ln International Units||Standard Deviation|Mean
817105|NCT01119703|Primary|Antibody Titer Responses to Hepatitis B Virus Surface Antigen (HBV sAg) Vaccine, Measured and Predicted Based on Pre-vaccination Biomarkers in Healthy, Elderly Participants.|"Healthy elderly participants were simultaneously vaccinated at baseline with hepatitis vaccine, tetanus-diphtheria booster vaccine, and cholera vaccine. Antibody titers to HBV sAg were then measured 1 month after final vaccination, based on enzyme linked immunosorbent assay (ELISA), and are defined as standardized international units of reactivity converted from optical densities, transformed to natural log (ln). In order to predict antibody responses blood samples were collected prior to vaccination at baseline, to measure a wide variety of biomarkers by messenger RNA (mRNA) profiling, biochemical and flow cytometric assays. These biomarkers were then used in a machine-learning (random-forest based) model to predict antibody titers, transformed to natural log (ln)."|Baseline and 1 month after final vaccination|Healthy participants 65 years of age and older who were treated with all three vaccines, and had their post-vaccination titers measured. Results from comparing titers and biomarker responses between younger and older cohorts are exploratory, and therefore not reported.||ln International Units||Standard Deviation|Mean
817106|NCT01119716|Primary|Complications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial Fibrillation||up to 60 days from day of treatment (cardioversion)|All enrolled participants with follow-up data available||Participants|||Number
817107|NCT01119716|Primary|Percentage of Participants Who Had a Successful Electrical or Pharmacological Cardioversion|Pharmacological cardioversion was considered successful if sinus rhythm or atrial rhythm was obtained within 24 hours after its initiation. Electrical cardioversion was considered successful if sinus rhythm was obtained and maintained for at least 10 minutes after the last shock was administered.|At time of treatment (up to 1 day from admission)|Participants who had artrial fibrillation treated by either electrical or pharmacological cardioversion.||Percentage of Participants|||Number
817108|NCT01119716|Primary|Treatments Utilized for Participants for Atrial Fibrillation||At time of Treatment (up to 1 day from admission)|All enrolled participants with available data pertaining to type of therapy(s) used to treat the participants atrial fibrillation.||Participants|||Number
817109|NCT01119716|Primary|Clinical Type of Atrial Fibrillation at Baseline (Admission)||Baseline (time of admission)|All enrolled participants with admission (baseline) atrial fibrillation data available.||Percentage of Participants|||Number
817110|NCT01119716|Primary|Co-Morbidity in Participants Presenting With Atrial Fibrillation at Baseline (Admission)||Baseline (time of admission)|All enrolled participants with co-morbity data available.||Percentage of Participants|||Number
817111|NCT01119716|Primary|Cardiovascular Disease History of Participants Presenting With Atrial Fibrillation at Baseline (Admission)||Baseline (time of admission)|All enrolled participants with baseline cardiovascular history data.||Percentage of Participants|||Number
817112|NCT01119755|Secondary|Mean Difference of Diastolic Home Blood Pressure Between Summer and Winter||1 year|||mmHg||Standard Deviation|Mean
817113|NCT01119755|Secondary|Mean Difference of Systolic Home Blood Pressure Between Summer and Winter||1 year|||mmHg||Standard Deviation|Mean
817114|NCT01119755|Secondary|Mean Difference of Diastolic Clinic Blood Pressure Between Summer and Winter||1 year|||mmHg||Standard Deviation|Mean
817115|NCT01119755|Primary|Mean Difference of Diastolic Night-time Ambulatory Blood Pressure Between Summer and Winter||1 year|||mmHg||Standard Deviation|Mean
817126|NCT01119768|Secondary|Time to First Relapse.|"Time to first relapse is from the last dose during the treatment period to date of first time patient comes to the investigator due to symptom recure and need for treatment.
Time to first relapse is actually the time when 50% of patients had relapse. Up to the end of study, there were less than 50% of the patients in arm esomeprazole 2 weeks group had relapse so was unable to compute this endpoint"|From baseline to 24 weeks after end of treatment|MITT was defined as patients in ITT population with symptom relief after 8 weeks or 2 weeks esomeprazole treatment.||days||Inter-Quartile Range|Median
817127|NCT01119768|Secondary|The Success Rate in Whole Study Duration.|Success is defined as patients with symptom relief after 8 weeks or 2 weeks esomeprazole treatment, and also get symptom controlled during maintenance treatment / follow-up period.|24 weeks after end of treatment|Intension to Treat (ITT) was defined as all randomized subjects who took at least one dose of treatment.||percentage of participants|||Number
817128|NCT01119768|Primary|Symptom Control Rate at 24 Weeks Assessed by Gerd Q Questionnaire.|GerdQ Scores ranging from 0 to 3 were applied for the positive predictors and from 3 to 0 (reversed order, where 3 = none) for negative predictors. The GerdQ score was calculated as the sum of these scores, giving a total score ranging from 0 to 18. When GerdQ ≥8, the patients could be symptom based diagnosed as GERD. GerdQ was consisted of 3 categories: A, B and C. Each category has two questions with sum of score ranging from 0 to 6. Symptom controlled was defined as patients with all items ≤1 in A and C category of GerdQ.|24 weeks|MITT was defined as patients in ITT population with symptom relief after 8 weeks or 2 weeks esomeprazole treatment||percentage of participants|||Number
817129|NCT01119794|Primary|Overall Response Rate (ORR) of the Combination of Ofatumumab and Bortezomib in Patients Receiving Study Treatment|"Response was assessed based on Bone marrow biopsy and CT scan. Best responses are used for Response Rate and CR and PR only.
Complete Response – CR:
• Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy.
Partial Response - PR:
• At least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses.
Stable Disease – SD:
• A patient is considered to have SD when he or she fails to attain the criteria needed for a CR or PR, but does not fulfill those for progressive disease
Relapsed Disease:
• Lymph nodes should be considered abnormal if the long axis is more than 1.5 cm regardless of the short axis."|Bone Marrow Biopsy: Every 2 months for 1 year then every 4 months until progression for approximately 1 year/Via CT scan: every 4 months until progression, for a total of approximately 2 years|8/10 patients were evaluable as 2 withdrew||participants|||Number
817130|NCT01119859|Secondary|Percentage of Patients With a European League Against Rheumatism (EULAR) Good or Moderate Response at Week 24|Change of the Disease Activity Score 28 score from baseline was used to determine EULAR responses of good, moderate, or no response. For a post-baseline score ≤ 3.2, a change from baseline of < -1.2 was a good response, < -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-baseline score > 3.2 to ≤ 5.1, a change from baseline of < -0.6 was a moderate response and ≥ -0.6 was no response. For a post-baseline score > 5.1, a change from baseline < -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-baseline scores > 3.2.|Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 efficacy assessment.||Percentage of patients|||Number
817131|NCT01119859|Secondary|Percentage of Patients With a European League Against Rheumatism (EULAR) Good Response at Week 24|Change of the Disease Activity Score 28 score from baseline was used to determine EULAR responses of good, moderate, or no response. For a post-baseline score ≤ 3.2, a change from baseline of < -1.2 was a good response, < -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-baseline score > 3.2 to ≤ 5.1, a change from baseline of < -0.6 was a moderate response and ≥ -0.6 was no response. For a post-baseline score > 5.1, a change from baseline < -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-baseline scores > 3.2.|Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 efficacy assessment.||Percentage of patients|||Number
817132|NCT01119859|Secondary|Percentage of Patients With an Improvement of at Least 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20/50/70) From Baseline at Week 24|Improvement must be seen in tender and swollen joint counts (28 assessed joints) and in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, the extreme left end of the line “no disease activity” [symptom-free and no arthritis symptoms] and the extreme right end “maximum disease activity”; patient assessment of pain in previous the 24 hours on a VAS (extreme left end of the line “no pain” and the extreme right end “unbearable pain”); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and erythrocyte sedimentation rate.|Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 efficacy assessment.||Percentage of patients|||Number
817133|NCT01119859|Secondary|Percentage of Patients With Low Disease Activity (Disease Activity Score 28 [DAS28] ≤ 3.2) at Week 24|The percentage of patients who had low rheumatic arthritis disease activity at Week 24, as measured by a DAS28 score of 3.2 or less, is reported.|Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 efficacy assessment.||Percentage of patients|||Number
817134|NCT01119859|Secondary|Percentage of Patients With a Remission Response (Disease Activity Score 28 [DAS28] < 2.6) at Week 24|The percentage of patients who achieved remission of their rheumatic arthritis at Week 24, as measured by a DAS28 score < 2.6, is reported.|Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 efficacy assessment.||Percentage of patients|||Number
817187|NCT01120184|Secondary|OS at Clinical Cutoff Among Those With High HER2 mRNA Levels|OS was defined as the time from randomization to death from any cause. Median duration of OS was estimated using Kaplan-Meier analysis.|Up to 70 months from randomization until clinical cutoff of 15-May-2016 (every 3 months until death, loss to follow-up, withdrawal, or study termination)|ITT Population (High HER2 mRNA Subpopulation).||months||Full Range|Median
834865|NCT01280604|Secondary|Alanine Aminotransferase(ALT)|ALT levels will be assessed in study participants 6-10 weeks after entry into study.|6-10 weeks|||international units/liter||Standard Deviation|Mean
817135|NCT01119859|Primary|Change From Baseline to Week 24 in the Disease Activity Score 28 (DAS28)|The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient’s global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A negative change score indicates improvement. The analysis was adjusted for stratification factors of duration of RA (≤ 2 years and > 2 years) and region (US and non-US).|Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 efficacy assessment.||Units on a scale||95% Confidence Interval|Mean
817136|NCT01119937|Secondary|Number of Patients With Notable Change From Baseline in Fridericia's QTc Values at Any Timepoint Over the Whole Treatment Period|Clinically notable change from baseline was and increase from baseline of 30 or greater milliseconds (ms).|52 weeks|Safety population - all patients who received at least one dose of study drug||participants|||Number
817137|NCT01119937|Secondary|Number of Patients With Newly Occurring or Worsening Clinically Notable Vital Signs Values at Any Timepoint Over the Whole Treatment Period|Clinically notable vital sign values were: pulse rate - low, <40 bpm or <=50 bpm and decrease from baseline >=15bpm; pulse rate high, >130 bpm or >=120bpm and increase from baseline >=15 bpm. Systolic blood pressure - low, <75 mmHg or <=90 mmHg and decrease from baseline >=20 mmHg; high, >200 mmHg or >=180 mmHg and increase from baseline >=20 mmHg. Diastolic blood pressure - low, <40 mmHg or <=50 mmHg and decrease from baseline >=15 mmHg; high, >115 mmHg or >=105 mmHg and increase from baseline >=15 mmHg.|52 weeks|Safety population - all patients who received at least one dose of study drug||participants|||Number
817138|NCT01119937|Secondary|Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Timepoint Over the Whole Treatment Period|Clinically notable biochemistry values were: total protein - <4.0 g/dL or >9.5 g/dL; albumin <2.5 g/dL; bilirubin (total) >1.9 mg/dL; BUN >27 mg/dL; creatinine >1.99 mg/dL; AST >3 x ULN U/L; ALT >3 x ULN U/L; ALP >3 x ULN U/L; y-GTP >3 x ULN U/L; sodium <125 mEq/L or >160 mEq/L; potassium <3.0 mEq/L or >6.0 mEq/L; glucose <51.0 mg/dL or >180.0 mg/dL|52 weeks|Safety population - all patients who received at least one dose of study drug||participants|||Number
817139|NCT01119937|Secondary|Number of Patients With Newly Occurring or Worsening Clinically Notable Hematology Values at Any Timepoint Over the Whole Treatment Period|Clinically notable hematology values were: hemoglobin - male <11.5g/dL, female <9.5 g/dL; hematocrit - male <37%, female <32%; white cell count - <2800µL or >16000µL; platelets - <7.5 10*4/µL or >70.0 10*4/µL|52 weeks|Safety population - all patients who received at least one dose of study drug. Only participants with the required measurements were included for each specific value.||participants|||Number
817140|NCT01119937|Secondary|Change From Baseline in Mean Daily Number of Puffs of Rescue Medication Over the Whole Treatment Period|Patients recorded rescue medication use in a paper patient diary. If a patient required the use of salbutamol as rescue medication due to an increase in COPD symptoms, the number of inhalations (puffs) taken was recorded in the patient diary.|52 weeks|Intent-to-treat (ITT) population - included all randomized patients who received at least one dose of study drug||change in puffs||Standard Deviation|Mean
817141|NCT01119937|Secondary|Change in St. George Respiratory Questionnaire From Baseline|SGRQ is a health related quality of life questionnaire consisting of 51 items in three components: symptoms, activity, and impacts. The lowest possible value is zero and the highest 100. Higher values correspond to greater impairment in quality of life.|Weeks 12, 24, 36, 52|Intent-to-treat (ITT) population - included all randomized patients who received at least one dose of study drug. Only participants with measurements at both baseline and the specified timepoint were included in the analysis for the specific timepoint.||score on a scale||Standard Deviation|Mean
817142|NCT01119937|Secondary|Number of Patients With Moderate or Severe COPD Exacerbations|Moderate COPD exacerbations were defined as: worsening of 2 or more of the following major symptoms for at least 2 consecutive days - dyspnea, sputum volume and sputum purulence; OR a worsening of any 1 major symptom with any 1 of the following minor symptoms for at least 2 consecutive days - sore throat, colds, fever without other cause, increased cough or increased wheeze, requiring treatment with systemic glucocorticosteroids or antibiotics or both. Severe COPD exacerbations were defined as: conditions for Moderate COPD exacerbation and hospitalization was required.|52 weeks|Intent-to-treat (ITT) population - included all randomized patients who received at least one dose of study drug||participants|||Number
817143|NCT01119937|Secondary|Time From Randomization Until the Start of the First Moderate or Severe COPD Exacerbation|Moderate COPD exacerbations were defined as: worsening of 2 or more of the following major symptoms for at least 2 consecutive days - dyspnea, sputum volume and sputum purulence; OR a worsening of any 1 major symptom with any 1 of the following minor symptoms for at least 2 consecutive days - sore throat, colds, fever without other cause, increased cough or increased wheeze, requiring treatment with systemic glucocorticosteroids or antibiotics or both. Severe COPD exacerbations were defined as: conditions for Moderate COPD exacerbation and hospitalization was required. Participants who withdraw from the study and do not experience a moderate or severe exacerbation are censored at the date of withdrawal. Participants who complete the study and do not experience a moderate or severe exacerbation are censored at the completion visit date.|52 weeks|Intent-to-treat (ITT) population - included all randomized patients who received at least one dose of study drug||days|||Number
817144|NCT01119937|Secondary|Change in Pre-dose FVC From Baseline|Pre-dose FVC is defined as the average of the measurements at 45 and 15 minutes pre-dose.|Weeks 12, 24, 36 and 52|Intent-to-treat (ITT) population - included all randomized patients who received at least one dose of study drug. Only participants with measurements at both baseline and the specified timepoint were included in the analysis for the specific timepoint.||liters||Standard Deviation|Mean
817145|NCT01119937|Secondary|Change in Pre-dose FEV1 From Baseline|Pre-dose FEV1 is defined as the average of the measurements at 45 and 15 minutes pre-dose.|Weeks 12, 24, 36 and 52|Intent-to-treat (ITT) population - included all randomized patients who received at least one dose of study drug. Only participants with measurements at both baseline and the specified timepoint were included in the analysis for the specific timepoint.||liters||Standard Deviation|Mean
817146|NCT01119937|Primary|Number of Participants With Adverse Events, Serious Adverse Events or Death|Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal lab finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgments of the investigators represent significant hazards.|52 weeks|Safety population - all patients who received at least one dose of study drug||participants|||Number
817147|NCT01119950|Other Pre-specified|Trough Forced Vital Capacity on Days 1, 7 and 14|"Trough Forced Vital Capacity (FVC) on Days 1, 7 and 14. FVC is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed via spirometry. (see Outcome Measure #23).
Trough FVC was defined as the mean of the 23 hour 15 minute and 23 hour 45 minute post-dose values."|Days 1, 7 and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.||Liters||Standard Deviation|Mean
817148|NCT01119950|Other Pre-specified|Peak Forced Expiratory Volume in One Second on Days 1, 7 and 14 of Treatment|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Peak FEV1 is the maximum FEV1 recorded in a pre-determined period of time.
Percentage of the maximal response of NVA237 doses on Peak FEV1 was measured on days 1, 7 and 14 of treatment."|Days 1, 7, and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.||Liters||Standard Deviation|Mean
817149|NCT01119950|Other Pre-specified|Forced Expiratory Volume in One Second at 12 Hours on Days 1 and 14 of Treatment|Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Percentage of the maximal response of NVA237 doses on FEV1 at 12 hours was measured on days 1 and 14.|Days 1 and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.||Liters||Standard Deviation|Mean
817150|NCT01119950|Other Pre-specified|Forced Expiratory Volume in One Second of Area Under the Curve 12-24 Hours Over Days 1, and 14 of Treatment|Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Percentage of the maximal response of NVA237 on FEV1 Area under the curve (AUC) 12-24 hours was calculated from measurements taken at 11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on Days 1 and 14. FEV1 AUC was calculated as the sum of trapezoids divided by the length of time.|11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on Days 1 and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.||Liters||Standard Deviation|Mean
817151|NCT01119950|Other Pre-specified|Forced Expiratory Volume in One Second Area Under the Curve 0-12 Hours at Day 1 and 14 of Treatment|Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Percentage of the maximal response of NVA237 doses was calculated on FEV1 Area Under the Curve (AUC) 0-12 hours from measurements taken at at 5 min,15 min, 1,2,3,4,6,8,10 hours, 11h 55 min (postdose) on days 1 and 14. FEV1 AUC was calculated as the sum of trapezoids divided by the length of time.|5 min,15 min, 1,2,3,4,6,8,10 hours, 11h 55 min (postdose) on days 1 and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.||Liters||Standard Deviation|Mean
817152|NCT01119950|Other Pre-specified|Forced Expiratory Volume in One Second of Area Under the Curve 0-8 Hours Days 1, 7, and 14|Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Percentage of the maximal response of NVA237 doses on FEV1 Area Under the Curve (AUC) 0-8 was calculated from measurements taken at 5 min,15 min, 1,2,3,4,6,8 hours (postdose) on days 1, 7, and 14. FEV1 AUC was calculated as the sum of trapezoids divided by the length of time.|at 5 min,15 min, 1,2,3,4,6,8 hours (postdose) on days 1, 7 and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.||Liters||Standard Deviation|Mean
817153|NCT01119950|Other Pre-specified|Forced Expiratory Volume in One Second Area Under the Curve 0-4 Hours on Days 1, 7 and 14 of Treatment|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Spirometry was performed according to internationally accepted standards.
FEV1 Area Under the Curve (AUC) measurements were taken at 5 min, 15 min, 1,2,3,4 hours (postdose) on days 1, 7 and 14 of treatment. FEV1 AUC was calculated as the sum of trapezoids divided by the length of time."|5 min,15 min, 1,2,3,4 hours (postdose) on Days 1, 7 and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.||Liters||Standard Deviation|Mean
817154|NCT01119950|Other Pre-specified|Forced Expiratory Volume in One Second Area Under the Curve 0-24 Hours on Days 1 and 14 of Treatment|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Spirometry was performed according to internationally accepted standards.
FEV1 Area Under the Curve (AUC) measurements were taken at 5 min, 15 min, 1,2,3,4,6,8,10 hours, 11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on days 1 and 14 of treatment. FEV1 AUC was calculated as the sum of trapezoids divided by the length of time."|5 min, 15 min, 1,2,3,4,6,8,10 hours, 11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on days 1 and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.||Liters||Standard Deviation|Mean
817188|NCT01120184|Secondary|Percentage of Participants Who Died Prior to Clinical Cutoff Among Those With High HER2 mRNA Levels|The percentage of participants who died prior to clinical cutoff was calculated as [number of participants with event divided by the number analyzed] multiplied by 100.|Up to 70 months from randomization until clinical cutoff of 15-May-2016 (every 3 months until death, loss to follow-up, withdrawal, or study termination)|ITT Population (High HER2 mRNA Subpopulation).||percentage of participants|||Number
817155|NCT01119950|Other Pre-specified|Trough Forced Expiratory Volume in One Second at Days 1, 7 and 14|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Spirometry was performed according to internationally accepted standards.
Trough FEV1 was measured on Days 1, 7 and 14 of treatment. Trough FEV1 was defined as the mean of the FEV1 values measured at 23 hours 15 mins and 23 hours 45 mins post-dose."|23 hours 15 mins and 23 hours 45 mins post-dose on Days 1, 7 and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.||Liters||Standard Deviation|Mean
817156|NCT01119950|Other Pre-specified|Trough Forced Vital Capacity After 28 Days of Treatment|Forced Vital Capacity (FVC) after 28 days of treatment. FVC is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed via spirometry. Trough FVC was defined as the mean of the FVC values measured at 23 hours 15 mins and 23 hours 45 mins post-dose.|23 hours 15 mins and 23 hours 45 mins post-dose on Day 28|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.||Liters||Standard Deviation|Mean
817157|NCT01119950|Other Pre-specified|Peak Forced Expiratory Volume in One Second at Day 28 of Treatment|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Spirometry was performed according to internationally accepted standards.
Peak FEV1 is the maximum FEV1 recorded in a pre-determined period of time. Measurements were taken at 25 min , 15 min pre-dose, 5 min, 15 min, 1 , 2 ,3 , 4 , 6 , 8 , 10 hours , 11 hour 55 min and 14 hour post-dose on day 28."|25 min , 15 min pre-dose, 5 min, 15 min, 1 , 2 ,3 , 4 , 6 , 8 , 10 hours , 11 hour 55 min and 14 hour post-dose on day 28|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.||Liters||Standard Deviation|Mean
817158|NCT01119950|Other Pre-specified|Forced Expiratory Volume in One Second at 12 Hours on Day 28 of Treatment|Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Spirometry was performed according to internationally accepted standards.|12 hours on day 28|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.||Liters||Standard Deviation|Mean
817159|NCT01119950|Other Pre-specified|Forced Expiratory Volume in One Second Area Under the Curve at Different Time Points (0-4 Hours, 0-8 Hours, 0-12 Hours, 12-24 Hours)|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Spirometry was performed according to internationally accepted standards.
FEV1 Area Under the Curve (AUC) measurements were taken at: 5 min,15 min, 1,2,3,4,6,8,10 hours, 11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose). FEV1 AUC was calculated as the sum of trapezoids divided by the length of time."|5 min,15 min, 1,2,3,4,6,8,10 hours, 11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on day 28|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.||Liters||Standard Deviation|Mean
817160|NCT01119950|Other Pre-specified|Forced Expiratory Volume in One Second Area Under the Curve 0-24 Hours at Day 28 of Treatment|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Spirometry was performed according to internationally accepted standards.
FEV1 Area Under the Curve (AUC) measurements were taken at 5 min, 15 min, 1,2,3,4,6,8,10 hours, 11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on day 28. FEV1 AUC was calculated as the sum of trapezoids divided by the length of time."|5 min, 15 min, 1,2,3,4,6,8,10 hours, 11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on day 28|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.||Liters||Standard Deviation|Mean
817161|NCT01119950|Other Pre-specified|Trough Forced Expiratory Volume in One Second by Treatment at Day 28|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Spirometry was performed according to internationally accepted standards.
Trough FEV1 was defined as the mean of the 23 hour 15 minute and 23 hour 45 minute post-dose values."|Day 28|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.||Liters||Standard Deviation|Mean
817162|NCT01119950|Primary|Maximal Response of Incremental Once Daily and Twice Daily Doses of NVA237 That Each Dose Achieves in Relation to the Maximal Effect of NVA237 on Trough Forced Expiratory Volume in One Second at Day 28|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. The maximal response of incremental once daily and twice daily doses of NVA237 that each dose achieves in relation to the maximal effect of NVA237 on Trough FEV1 was measured at Day 28. FEV1 was measured in response to all doses administered (see Outcome Measure #19).
All trough FEV1 responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebo-corrected data, and extrapolated to estimate the maximal response. All trough FEV1 data are reported as a percentage of the theoretical maximal response.
Trough FEV1 was defined as the mean of the 23 hour 15 minute and 23 hour 45 minute post-dose values."|Day 28|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.||Percentage of maximal response||90% Confidence Interval|Mean
817163|NCT01119950|Secondary|Mean Daily Use of Rescue Medication by Treatment at Different Time Points|Mean daily use of rescue medication by treatment and time points. Baseline was defined as the average of the total number of puffs of rescue medication during the week prior to treatment start, divided by the total number of days with non-missing rescue data during that week, then puffs were counted during weeks 1, 2, 3 and 4 postdose.|Baseline, Weeks 1, 2, 3 and 4|Only patients with a non-missing value at both period baseline and the respective post-baseline visit were included. The modeling approach is not suitable for these data as the modeling assumptions do not hold.||Number of Puffs||Standard Deviation|Mean
819412|NCT01136746|Secondary|Percentage of Plasma Glucose Measurements Within Range 71 to 179 mg/dL by Hospital Day|Due to low enrollment, this outcome measure was not analyzed.|Day 1 up to day 10 of hospital study period|Due to low enrollment, zero participants were analyzed.|||||
817164|NCT01119950|Secondary|Percentage of the Maximal Response of NVA237 Doses on Trough Forced Vital Capacity on Days 1, 7 and 14|"Percentage of the maximal response of NVA237 Doses on Trough Forced Vital Capacity (FVC) on Days 1, 7 and 14. FVC is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Trough FVC was assessed via spirometry. (see Outcome Measure #33).
Trough FVC is defined as the mean of the FVC values measured at 23 hours 15 mins and 23 hours 45 mins post-dose."|Days 1, 7 and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.||Percentage of maximal response||90% Confidence Interval|Mean
817165|NCT01119950|Secondary|Percentage of the Maximal Response of NVA237 Doses on Peak Forced Expiratory Volume in One Second on Days 1, 7 and 14 of Treatment|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Peak FEV1 is the maximum FEV1 recorded in a pre-determined period of time.
Percentage of the maximal response of NVA237 doses on Peak FEV1 was measured on days 1, 7 and 14 of treatment.
Peak FEV1 was measured in response to all doses administered (see Outcome Measure #32). All FEV1 responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebo-corrected data, and extrapolated to estimate the maximal response. All FEV1 data are reported as a percentage of the theoretical maximal response."|Days 1, 7, and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.||Percentage of maximal response||90% Confidence Interval|Mean
817166|NCT01119950|Secondary|Percentage of the Maximal Response of NVA237 Doses on Forced Expiratory Volume in One Second at 12 Hours on Days 1 and 14 of Treatment|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Percentage of the maximal response of NVA237 doses on FEV1 at 12 hours was measured on days 1 and 14.
FEV1 was measured in response to all doses administered (see Outcome Measure #31). All FEV1 responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebo-corrected data, and extrapolated to estimate the maximal response. All FEV1 data are reported as a percentage of the theoretical maximal response."|Days 1 and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.||Percentage of maximal response||90% Confidence Interval|Mean
817167|NCT01119950|Secondary|Percentage of the Maximal Response of NVA237 Doses on Forced Expiratory Volume in One Second of Area Under the Curve 12-24 Hours Over Days 1, and 14 of Treatment|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Percentage of the maximal response of NVA237 on FEV1 Area under the curve (AUC) 12-24 hours was calculated from measurements taken at 11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on Days 1 and 14.
AUC FEV1 was measured in response to all doses administered (see Outcome Measure #30). All FEV1 responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebo-corrected data, and extrapolated to estimate the maximal response. All FEV1 data are reported as a percentage of the theoretical maximal response."|11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on Days 1 and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.||Percentage of maximal response* hours||90% Confidence Interval|Mean
817168|NCT01119950|Secondary|Percentage of the Maximal Response of NVA237 Doses on Forced Expiratory Volume in One Second Area Under the Curve 0-12 Hours at Day 1 and 14 of Treatment|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Percentage of the maximal response of NVA237 doses was calculated on FEV1 Area Under the Curve (AUC) 0-12 hours from measurements taken at at 5 min,15 min, 1,2,3,4,6,8,10 hours, 11h 55 min (postdose) on days 1 and 14 in response to all doses administered (see Outcome Measure #29).
All AUC FEV1 responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebo-corrected data, and extrapolated to estimate the maximal response. All FEV1 data are reported as a percentage of the theoretical maximal response."|5 min,15 min, 1,2,3,4,6,8,10 hours, 11h 55 min (postdose) on days 1 and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.||Percentage of maximal response* hours||90% Confidence Interval|Mean
817169|NCT01119950|Secondary|Percentage of the Maximal Response of NVA237 Doses on Forced Expiratory Volume in One Second of Area Under the Curve 0-8 Hours Days 1, 7, and 14|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Percentage of the maximal response of NVA237 doses on FEV1 Area Under the Curve (AUC) 0-8 was calculated from measurements taken at 5 min,15 min, 1,2,3,4,6,8 hours (postdose) on days 1, 7, and 14.
AUC FEV1 was measured in response to all doses administered (see Outcome Measure #28). All FEV1 responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebo-corrected data, and extrapolated to estimate the maximal response. All FEV1 data are reported as a percentage of the theoretical maximal response."|at 5 min,15 min, 1,2,3,4,6,8 hours (postdose) on days 1, 7 and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.||Percentage of maximal response* hours||90% Confidence Interval|Mean
817170|NCT01119950|Secondary|Percentage of the Maximal Response of NVA237 Doses on Forced Expiratory Volume in One Second Area Under the Curve 0-4 Hours on Days 1, 7 and 14 of Treatment|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer.
Percentage of the maximal response of NVA237 doses on FEV1 Area Under the Curve (AUC) 0-4 hours was calculated from measurements taken at 5 min,15 min, 1,2,3,4 hours (postdose) on Days 1, 7 and 14, in response to all doses administered (see Outcome Measure #27).
All AUC FEV1 responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebo-corrected data, and extrapolated to estimate the maximal response. All FEV1 data are reported as a percentage of the theoretical maximal response."|5 min,15 min, 1,2,3,4 hours (postdose) on Days 1, 7 and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.||Percentage of maximal response* hours||90% Confidence Interval|Mean
817171|NCT01119950|Secondary|Percentage of the Maximal Effect of NVA237 Doses on Forced Expiratory Volume in One Second Area Under the Curve 0-24 Hours on Days 1 and 14 of Treatment|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer.
Percentage of the maximal response of NVA237 doses on FEV1 Area Under the Curve (AUC) 0-24 hours, was calculated from measurements taken at 5 min,15 min, 1,2,3,4,6,8,10 hours, 11 hours 55min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on days 1 and 14.
FEV1 AUC 0-24 hours was measured on days 1 and 14 of treatment in response to all doses administered (see Outcome Measure #26). All FEV1 responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebo-corrected data, and extrapolated to estimate the maximal response. All FEV1 data are reported as a percentage of the theoretical maximal response."|5 min,15 min, 1,2,3,4,6,8,10 hours, 11 hours 55min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on days 1 and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.||Percentage of maximal response* hours||90% Confidence Interval|Mean
817172|NCT01119950|Secondary|Percentage of the Maximal Response of NVA237 Doses on Trough Forced Expiratory Volume in One Second at Days 1, 7 and 14|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Percentage of the maximal response of NVA237 doses on Trough FEV1 was measured on Days 1, 7 and 14.
Through FEV1 was measured in response to all doses administered (see Outcome Measure #25). All FEV1 responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebo-corrected data, and extrapolated to estimate the maximal response. All FEV1 data are reported as a percentage of the theoretical maximal response.
Trough FEV1 was defined as the mean of the 23 hour 15 minute and 23 hour 45 minute post-dose values."|Days 1, 7 and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.||Percentage of maximal response||90% Confidence Interval|Mean
817173|NCT01119950|Secondary|Percentage of the Maximal Response of NVA237 Doses on Forced Vital Capacity at Day 28 of Treatment|"Percentage of the maximal response of NVA237 within different doses/regimens of NVA237 on Forced Vital Capacity (FVC) was measured at day 28 of treatment. FVC is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.
FVC at day 28 of treatment was measured via spirometry (see Outcome Measure #24). All FVC responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebo-corrected data, and extrapolated to estimate the maximal response. All FVC data are reported as a percentage of the theoretical maximal response."|day 28|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.||Percentage of maximal response||90% Confidence Interval|Mean
817174|NCT01119950|Secondary|Percentage of the Maximal Response of NVA237 Doses on Peak Forced Expiratory Volume in One Second at Day 28 of Treatment|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Peak FEV1 is the maximum FEV1 recorded in a pre-determined period of time.
Percentage of the maximal response of NVA237 within different doses/regimens of NVA237 on Peak FEV1 was measured at day 28 of treatment.
Peak FEV1 was measured in response to all doses administered (see Outcome Measure #23). All FEV1 responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebo-corrected data, and extrapolated to estimate the maximal response. All FEV1 data are reported as a percentage of the theoretical maximal response."|day 28|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.||Percentage of maximal response||90% Confidence Interval|Mean
817175|NCT01119950|Secondary|Percentage of the Maximal Response of NVA237 Doses on Forced Expiratory Volume in One Second at 12 Hours at Day 28 of Treatment|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Percentage of the maximal response within different doses/regimens of NVA237 was measured using FEV1 at 12 hours on day 28 of treatment.
FEV1 was measured in response to all doses administered (see Outcome Measure #22). All FEV1 responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebo-corrected data, and extrapolated to estimate the maximal response. All FEV1 data are reported as a percentage of the theoretical maximal response."|12 hours on day 28|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.||Percentage of maximal response||90% Confidence Interval|Mean
817176|NCT01119950|Secondary|Percentage of the Maximal Response of NVA237 Doses on Forced Expiratory Volume in One Second Area Under the Curve at Different Time Points (0-4 Hours, 0-8 Hours, 0-12 Hours, 12-24 Hours) on Day 28|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer.
Percentage of the maximal response of NVA237 doses on FEV1 Area Under the Curve (AUC) 0-4 Hours, 0-8 Hours, 0-12 Hours, 12-24 Hours were calculated from measurements taken at: 5 min, 15 min, 1,2,3,4,6,8,10 hours, 11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on day 28.
AUC FEV1 was measured in response to all doses administered (see Outcome Measure #21). All FEV1 responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebo-corrected data, and extrapolated to estimate the maximal response. All FEV1 data are reported as a percentage of the theoretical maximal response."|5 min,15 min, 1,2,3,4,6,8,10 hours, 11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on day 28|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.||Percentage of maximal response* hours||90% Confidence Interval|Mean
817220|NCT01120184|Secondary|Overall Survival (OS) at Clinical Cutoff|OS was defined as the time from randomization to death from any cause. Median duration of OS was estimated using Kaplan-Meier analysis, and corresponding CIs were computed using the Brookmeyer-Crowley method.|Up to 70 months from randomization until clinical cutoff of 15-May-2016 (every 3 months until death, loss to follow-up, withdrawal, or study termination)|ITT Population.||months||95% Confidence Interval|Median
827176|NCT01202253|Secondary|Percentage of Participants Who Received 100 mg Dose on Day 2||Day 2|Full analysis set included all participants who met the defined eligibility criteria.||percentage of participants||95% Confidence Interval|Number
817177|NCT01119950|Secondary|Forced Expiratory Volume in One Second AUC 0-24 Hours for Once and Twice Daily Regimens of NVA237 for the Same Total Daily Dose of NVA237, After 28 Days of Treatment|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer.
The Area Under the Curve (AUC) 0-24 hours FEV1 between dosing regimens over the range 20 micrograms to 55 micrograms total daily dose at -25 min,-15 min (predose); 5 min, 15 min, 1,2,3,4,6,8,10 hours, 11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on day 28.
AUC 0-24 hours FEV1 was measured in response to all doses administered (12.5 µg q.d., 25.0 µg q.d., 12.5 µg b.i.d., 50 µg q.d., 25 µg b.i.d., 100 µg q.d., 50.0 µg b.i.d., and Placebo; see Outcome Measure # 20), and was used to compute modeled dose-response curves for once-daily and twice-daily regimens separately. The difference between those curves was computed at pre-specified theoretical doses (20 µg, 25 µg, 30 µg, 35 µg, 40 µg, 45 µg, 50 µg, and 55 µg) chosen at points likely to show the largest differences between the once-daily and twice-daily regimens."|-25 min,-15 min (predose); 5 min,15 min, 1,2,3,4,6,8,10 hours, 11 hours 55min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on day 28|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.||Liters||90% Confidence Interval|Mean
817178|NCT01119950|Secondary|Percentage of the Maximal Response of NVA237 Doses on Forced Expiratory Volume in One Second Area Under the Curve 0-24 Hours at Day 28 of Treatment|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer.
Percentage of the maximal response of NVA237 doses on FEV1 Area Under the Curve (AUC) 0-24 hours at day 28 of treatment was calculated from measurements taken at 5 min, 15 min, 1,2,3,4,6,8,10 hours, 11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on day 28.
AUC FEV1 was measured in response to all doses administered (see Outcome Measure #20). All FEV1 responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebo-corrected data, and extrapolated to estimate the maximal response. All FEV1 data are reported as a percentage of the theoretical maximal response."|5 min, 15 min, 1,2,3,4,6,8,10 hours, 11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on day 28|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.||Percentage of maximal response * hours||90% Confidence Interval|Mean
817179|NCT01119950|Secondary|Trough Forced Expiratory Volume in One Second for Once and Twice Daily Regimens of NVA237 for the Same Total Daily Dose of NVA237|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer.
FEV1 was measured between dosing regimens (over the range 20 micrograms to 55 micrograms total daily dose) after 28 days of treatment.
Mean trough FEV1 was measured in response to all doses administered (12.5 µg q.d., 25.0 µg q.d., 12.5 µg b.i.d., 50 µg q.d., 25 µg b.i.d., 100 µg q.d., 50.0 µg b.i.d., and Placebo; see Outcome Measure # 19), and was used to compute modeled dose-response curves for once-daily and twice-daily regimens separately. The difference between those curves was computed at pre-specified theoretical doses (20 µg, 25 µg, 30 µg, 35 µg, 40 µg, 45 µg, 50 µg, and 55 µg) chosen at points likely to show the largest differences between the once-daily and twice-daily regimens. The theoretical responses to each dosing schedule separately and the difference between the once-daily and twice-daily regimens are represented below."|day 28|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.||Liters||90% Confidence Interval|Mean
817180|NCT01120067|Primary|McGill Pain Questionnaire|McGill Pain Questionnaire (MPQ; Melzack, 1975): is a self-report questionnaire consisting of 102 words separated into three major classes; the sensory, affective, and evaluative aspects of pain. Respondents are asked to circle the word that best describes their pain. The stability, reliability, and validity of the MPQ have been established (Reading, Everitt, & Sledmere, 1982). The MPQ total score ranges from 0 to 78 with higher values indicating more significant pain.|6 months|||units on a scale||Standard Deviation|Mean
817181|NCT01120093|Secondary|Change From Baseline in Morning Pre-dose Forced Expiratory Volume in First Second (FEV1) at Day 7 on Treatment||Day 7|Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1||Liters||Standard Error|Least Squares Mean
817182|NCT01120093|Secondary|Change From Baseline in Forced Expiratory Volume in First Second (FEV1) Area Under Curve (AUC) 0-24h at Day 7 on Treatment||Day 7|Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1||Liters||Standard Error|Least Squares Mean
817183|NCT01120093|Secondary|Change From Baseline in Forced Expiratory Volume in First Second (FEV1) Area Under Curve (AUC) 12-24h at Day 7 on Treatment||Day 7|Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1||Liters||Standard Error|Least Squares Mean
817184|NCT01120093|Primary|Change From Baseline in Forced Expiratory Volume in First Second (FEV1) Area Under Curve (AUC) 0-12h at Day 7 on Treatment||Day 7|Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1||Liters||Standard Error|Least Squares Mean
817185|NCT01120184|Secondary|OS at Clinical Cutoff Among Those With Low HER2 mRNA Levels|"OS was defined as the time from randomization to death from any cause. Median duration of OS was estimated using Kaplan-Meier analysis. Reported upper bound of confidence interval for Trastuzumab Emtansine + Placebo and confidence interval values for Trastuzumab + Taxane and Trastuzumab Emtansine + Pertuzumab are censored values."|Up to 70 months from randomization until clinical cutoff of 15-May-2016 (every 3 months until death, loss to follow-up, withdrawal, or study termination)|ITT Population (Low HER2 mRNA Subpopulation).||months||Full Range|Median
817186|NCT01120184|Secondary|Percentage of Participants Who Died Prior to Clinical Cutoff Among Those With Low HER2 mRNA Levels|The percentage of participants who died prior to clinical cutoff was calculated as [number of participants with event divided by the number analyzed] multiplied by 100.|Up to 70 months from randomization until clinical cutoff of 15-May-2016 (every 3 months until death, loss to follow-up, withdrawal, or study termination)|ITT Population (Low HER2 mRNA Subpopulation).||percentage of participants|||Number
817189|NCT01120184|Secondary|PFS According to IRF Assessment Among Those With Low HER2 mRNA Levels|Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. PFS was defined as the time from randomization to first documented disease progression or death from any cause. Disease progression was defined as a ≥20% and 5-mm increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). Median duration of PFS was estimated using Kaplan-Meier analysis.|Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)|ITT Population (Low HER2 mRNA Subpopulation).||months||Full Range|Median
817190|NCT01120184|Secondary|Percentage of Participants With Death or Disease Progression According to IRF Assessment Among Those With Low HER2 mRNA Levels|Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. Disease progression was defined as a ≥20% and 5-mm increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). The percentage of participants with death or disease progression was calculated as [number of participants with event divided by the number analyzed] multiplied by 100.|Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)|ITT Population (Low HER2 mRNA Subpopulation).||percentage of participants|||Number
817191|NCT01120184|Secondary|PFS According to IRF Assessment Among Those With High HER2 mRNA Levels|Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. PFS was defined as the time from randomization to first documented disease progression or death from any cause. Disease progression was defined as a ≥20% and 5-mm increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). Median duration of PFS was estimated using Kaplan-Meier analysis.|Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)|ITT Population (High HER2 mRNA Subpopulation).||months||Full Range|Median
817192|NCT01120184|Secondary|Percentage of Participants With Death or Disease Progression According to IRF Assessment Among Those With High HER2 mRNA Levels|Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. Disease progression was defined as a ≥20% and 5-mm increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). The percentage of participants with death or disease progression was calculated as [number of participants with event divided by the number analyzed] multiplied by 100.|Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)|ITT Population (High HER2 mRNA Subpopulation).||percentage of participants|||Number
817193|NCT01120184|Secondary|Percentage of Participants With a Best Overall Response of CR or PR According to IRF Assessment Among Those With Low HER2 mRNA Levels|Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. CR was defined as the disappearance of all target and non-target lesions and short-axis reduction in pathological lymph nodes to <10 mm. PR was defined as a ≥30% decrease in sum of diameters of target lesions, taking as reference the Baseline sum. Response was determined using 2 consecutive tumor assessments at least 4 weeks apart. The percentage of participants with a best overall response of CR or PR (ie, the ORR) was calculated as [number of participants meeting the respective criteria divided by the number analyzed] multiplied by 100.|Up to 46 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)|ITT Population (Low HER2 mRNA Subpopulation): All randomized participants with below-the-median HER2 mRNA expression (value less than or equal to [≤] 59.71). Only participants with measurable disease at Baseline were included in the analysis.||percentage of participants|||Number
817194|NCT01120184|Secondary|Percentage of Participants With a Best Overall Response of CR or PR According to IRF Assessment Among Those With High Human Epidermal Growth Factor Receptor 2 (HER2) Messenger Ribonucleic Acid (mRNA) Levels|Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. CR was defined as the disappearance of all target and non-target lesions and short-axis reduction in pathological lymph nodes to <10 mm. PR was defined as a ≥30% decrease in sum of diameters of target lesions, taking as reference the Baseline sum. Response was determined using 2 consecutive tumor assessments at least 4 weeks apart. The percentage of participants with a best overall response of CR or PR (ie, the ORR) was calculated as [number of participants meeting the respective criteria divided by the number analyzed] multiplied by 100.|Up to 46 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)|ITT Population (High HER2 mRNA Subpopulation): All randomized participants with above-the-median HER2 mRNA expression (value greater than [>] 59.71). Only participants with measurable disease at Baseline were included in the analysis.||percentage of participants|||Number
817221|NCT01120184|Secondary|Percentage of Participants Who Died Prior to Clinical Cutoff|The percentage of participants who died prior to clinical cutoff was calculated as [number of participants with event divided by the number analyzed] multiplied by 100.|Up to 70 months from randomization until clinical cutoff of 15-May-2016 (every 3 months until death, loss to follow-up, withdrawal, or study termination)|ITT Population.||percentage of participants|||Number
817271|NCT01120236|Secondary|Accuracy of the Prognostic Model of Undetectable PSA (Developed From SWOG-9346)|The logistic regression algorithm for predicting undetectable PSA that was developed for SWOG-9346 using its baseline risk factors (age at registration, performance status, baseline PSA, and bone pain) will be applied to each arm of this trial to evaluate the level of agreement between the observed and predicted undetectable PSA rates.|Up to 5 years||||||
817195|NCT01120184|Secondary|Change From Baseline in Activity Impairment According to Work Productivity and Activity Impairment (WPAI) Questionnaire Score|The WPAI is a patient-reported measure which assesses the effect of general health and symptom severity on work productivity and regular activities. The General Health questionnaire asks participants to estimate the number of hours missed from work due to reasons related and unrelated to their health problems, as well as the total number of hours actually worked in the preceding 7-day period. The percentage of participants reporting that they were employed (working for pay) was assessed at baseline was assessed along with Absenteeism (work time missed), Presenteeism (impairment at work / reduced on-the-job effectiveness), Work productivity loss (overall work impairment / absenteeism plus presenteeism), and Activity Impairment. The reported changes represent change from baseline at Cycle 7. The score range for the scales of the WPAI is between 0 (no effect) to 100% (max effect).|Baseline, Cycle 7 (Week 18)|Number of participants analysed=participants from ITT population who reported conduct of daily activities. Here, 'n' signifies the number of participants with available data at specified category.||units on a scale||95% Confidence Interval|Mean
817196|NCT01120184|Secondary|Change From Baseline in Work Productivity According to Work Productivity and Activity Impairment (WPAI) Questionnaire Score|The WPAI is a patient-reported measure which assesses the effect of general health and symptom severity on work productivity and regular activities. The General Health questionnaire asks participants to estimate the number of hours missed from work due to reasons related and unrelated to their health problems, as well as the total number of hours actually worked in the preceding 7-day period. The percentage of participants reporting that they were employed (working for pay) was assessed at baseline was assessed along with Absenteeism (work time missed), Presenteeism (impairment at work / reduced on-the-job effectiveness), Work productivity loss (overall work impairment / absenteeism plus presenteeism), and Activity Impairment. The reported changes represent change from baseline at Cycle 7. The score range for the scales of the WPAI is between 0 (no effect) to 100% (max effect)|Baseline, Cycle 7 (Week 18)|Number of participants analysed=participants from ITT population who were employed at baseline. Here, 'n' signifies the number of participants with available data at specified category.||percent of work||95% Confidence Interval|Mean
817197|NCT01120184|Secondary|Change From Baseline in Rotterdam Symptom Checklist (RSCL) Activity Level Scale Score|The RSCL is a self-reported instrument which consists of 4 domains including physical symptom distress, psychological distress, activity level, and overall global life quality. Only the activity level scale was collected and assessed. Scores may range from 0 to 100, with higher scores indicating increased burden of disease. Mean RSCL activity scale score changes were calculated as [mean score at the assessment visit minus mean score at Baseline]. The higher the score, the higher the level of impairment or burden.|Baseline, Cycle 7 (Week 18)|ITT Population. Here, 'n' signifies the number of participants with available data at baseline and Cycle 7 (Week 18).||units on a scale||95% Confidence Interval|Mean
817198|NCT01120184|Secondary|Time to Deterioration in HRQoL as Assessed by FACT-B TOI-PFB Score|The FACT-B is a self-reported instrument which measures HRQOL of participants with breast cancer. It consists of 5 subscales including PWB, SWB, EWB, FWB, and BCS. The TOI-PFB score is taken by adding the scores from the PWB (7 items), FWB (7 items), and BCS (9 items) subscales. Items are rated from 0 (not at all) to 4 (very much) and a total score is derived. Scores may range from 0 to 92, with higher scores indicating better HRQOL. A 5 point change has been identified as the clinically minimal important difference (CMID) on the FACT-TOI-PFB scale. Time to deterioration was defined as the time from Baseline until the first decrease in FACT-B TOI-PFB score. Median time to deterioration was estimated using Kaplan-Meier analysis, and corresponding CIs were computed using the Brookmeyer-Crowley method.|Baseline up to 39 months from randomization until clinical cutoff of 16-Sept-2014|ITT Population. Number of participants analyzed=participants with baseline and at least one post baseline FACT-B TOI-PFB score.||months||95% Confidence Interval|Median
817199|NCT01120184|Secondary|Percentage of Participants With a Clinically Significant Deterioration in Health Related Quality of Life (HRQoL) as Measured by FACT Breast (FACT-B) Trial Outcome Index-Physical Function Breast (TOI-PFB) Score|The FACT-B is a self-reported instrument which measures HRQOL of participants with breast cancer. It consists of 5 subscales including physical well-being (PWB), social well-being (SWB), emotional well-being (EWB), functional well-being (FWB), and a breast cancer subscale (BCS). The TOI-PFB score is taken by adding the scores from the PWB (7 items), FWB (7 items), and BCS (9 items) subscales. Items are rated from 0 (not at all) to 4 (very much) and a total score is derived. Scores may range from 0 to 92, with higher scores indicating better HRQOL. A 5 point change has been identified as the clinically minimal important difference (CMID) on the FACT-TOI-PFB scale. The percentage of participants with deterioration was calculated as [number of participants meeting the above threshold divided by the number analyzed] multiplied by 100.|Up to 39 months from randomization until clinical cutoff of 16-Sept-2014 (at Baseline, on Day 1 of Cycles 2 to 8 and every even-numbered cycle thereafter and/or up to 42 days after last dose)|ITT Population. Number of participants analyzed=participants with baseline and at least one post baseline FACT-B TOI-PFB score.||percentage of participants|||Number
817200|NCT01120184|Secondary|Percentage of Participants Reporting Diarrhea According to the Relevant Single Items of The FACT-C Module|The FACT-C is a self-reported instrument which measures HRQOL pertaining to colorectal cancer. Response options on each question may range from 0 (not at all) to 4 (very much). The percentage of participants with diarrhea was calculated using following formula: [number of participants with any level of either symptom divided by the number analyzed] multiplied by 100.|At Baseline, Day 8 of Cycle 1, and Days 1 and 8 of Cycle 2|ITT Population (Protocol Amendment C Subpopulation). Only participants with a FACT-C score at the designated visit (n) were included in the analysis.||percentage of participants|||Number
817201|NCT01120184|Secondary|Percentage of Participants Reporting Nausea According to the Relevant Single Items of The FACT Colorectal Cancel (FACT-C) Module|The FACT-C is a self-reported instrument which measures HRQOL pertaining to colorectal cancer. Response options on each question may range from 0 (not at all) to 4 (very much). The percentage of participants with nausea was calculated using following formula: [number of participants with any level of either symptom divided by the number analyzed] multiplied by 100.|At Baseline, Day 8 of Cycle 1, and Days 1 and 8 of Cycle 2|ITT Population (Protocol Amendment C Subpopulation). Only participants with a FACT-C score at the designated visit (n) were included in the analysis.||percentage of participants|||Number
819836|NCT01138475|Secondary|Serum Phosphorus|This secondary outcome measure is change in serum phosphorus from baseline to final measure at 6 weeks differences in the 3 arms were compared|6 weeks|missing data from all 3 participant arms||mg/dL||Standard Deviation|Mean
817202|NCT01120184|Secondary|Percentage of Participants Experiencing a Clinically Significant Increase in Taxane-Related Treatment Symptoms as Measured by Taxane Subscale of the Functional Assessment of Cancer Therapy (FACT) Taxane (FACT-TaxS) Score|The FACT-Taxane is a self-reported instrument which measures the health-related quality of life (HRQOL) of participants receiving taxane-containing chemotherapy. The FACT-TaxS consists of 16 items including 11 neurotoxicity-related questions and 5 additional questions assessing arthralgia, myalgia, and skin discoloration. Items are rated from 0 (not at all) to 4 (very much) and a total score is inversely derived. Scores may range from 0 to 64, with higher scores indicating fewer/no symptoms. A minimally clinically important difference in treatment-related symptoms was defined as a ≥5% decrease (ie, 3.2 points) in FACT-TaxS score from Baseline. The percentage of participants with treatment-related symptoms was calculated using following formula: [number of participants meeting the above threshold divided by the number analyzed] multiplied by 100. Corresponding CIs were computed using the Blyth-Still-Casella exact method.|Up to 39 months from randomization until clinical cutoff of 16-Sept-2014 (at Baseline, on Day 1 of Cycles 2 to 8 and every even-numbered cycle thereafter and/or up to 42 days after last dose)|ITT Population (Protocol Amendment C Subpopulation): All randomized participants who entered the study after Protocol Amendment C.||percentage of participants||95% Confidence Interval|Number
817203|NCT01120184|Secondary|Percentage of Participants With a Best Overall Response of CR, PR, or Stable Disease (SD) According to IRF Assessment|Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. CR was defined as the disappearance of all target and non-target lesions and short-axis reduction in pathological lymph nodes to <10 mm. PR was defined as a ≥30% decrease in sum of diameters of target lesions, taking as reference the Baseline sum. SD was defined as neither sufficient shrinkage to quality for PR nor sufficient (20%) increase to qualify for disease progression. Response was determined using 2 consecutive tumor assessments at least 4 weeks apart. The percentage of participants with a best overall response of CR, PR, or SD was calculated as [number of participants meeting the respective criteria divided by the number analyzed] multiplied by 100.|Up to 46 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)|Data were not analyzed. Protocol Amendment E removed this outcome measure as a secondary endpoint, because it was redundant to another prespecified secondary endpoint.|||||
817204|NCT01120184|Secondary|Duration of Response According to IRF Assessment|Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. Duration of response was defined as the time from confirmed PR or CR to first documented disease progression or death from any cause. CR was defined as the disappearance of all target lesions and non-target lesions and short-axis reduction in pathological lymph nodes to <10 mm. PR was defined as a ≥30% decrease in sum of diameters of target lesions, taking as reference the Baseline sum. Response was determined using 2 consecutive tumor assessments at least 4 weeks apart. Median duration of response was estimated using Kaplan-Meier analysis, and corresponding CIs were computed using the Brookmeyer-Crowley method.|Up to 46 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)|ITT Population. Only participants achieving CR or PR were included in the analysis.||months||95% Confidence Interval|Median
817205|NCT01120184|Secondary|Percentage of Participants With Objective Response According to Investigator Assessment|Objective response was defined as having CR or PR, assessed according to RECIST version 1.1, by investigator. CR was defined as the disappearance of all target and non-target lesions and short-axis reduction in pathological lymph nodes to <10 mm. PR was defined as a ≥30% decrease in sum of diameters of target lesions, taking as reference the Baseline sum. Response was determined using 2 consecutive tumor assessments at least 4 weeks apart. The percentage of participants with a best overall response of CR or PR (ie, the ORR) was calculated as [number of participants meeting the respective criteria divided by the number analyzed] multiplied by 100. Corresponding CIs were computed using the Blyth-Still-Casella exact method.|Up to 46 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)|ITT Population.||percentage of participants||95% Confidence Interval|Number
817206|NCT01120184|Secondary|Percentage of Participants With Objective Response According to IRF Assessment|Objective response was defined as having complete response (CR) or partial response (PR), assessed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. CR was defined as the disappearance of all target and non-target lesions and short-axis reduction in pathological lymph nodes to <10 mm. PR was defined as a ≥30% decrease in sum of diameters of target lesions, taking as reference the Baseline sum. Response was determined using 2 consecutive tumor assessments at least 4 weeks apart. The percentage of participants with a best overall response of CR or PR (ie, the objective response rate [ORR]) was calculated as [number of participants meeting the respective criteria divided by the number analyzed] multiplied by 100. Corresponding CIs were computed using the Blyth-Still-Casella exact method.|Up to 46 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)|ITT Population. Only participants with measurable disease at Baseline were included in the analysis.||percentage of participants||95% Confidence Interval|Number
817207|NCT01120184|Secondary|Percentage of Participants With Hospitalization|Hospitalization was defined as a non-administration-related hospitalization due to serious adverse event, while on study treatment.|Up to 48 months from randomization until clinical cutoff of 16-Sept-2014|Safety population||percentage of participants||95% Confidence Interval|Number
817208|NCT01120184|Secondary|Hospitalization Days|Hospitalization was defined as a non-administration-related hospitalization due to serious adverse event, while on study treatment. Reported values represent number of days admitted per participants.|Up to 48 months from randomization until clinical cutoff of 16-Sept-2014|Safety population. Number of participants analyzed=participants with hospitalization and data available for calculation of the parameter.||days||Full Range|Median
817947|NCT01123941|Primary|Number of Subjects Reporting Any Post Immunization Reactions|Solicited reactions collected during the 7-day period after vaccination are pain, erythema, induration, chills, malaise, myalgia, headache, arthralgia and fatigue.|During the 7-day period after vaccination|||participants|||Number
817209|NCT01120184|Secondary|Percentage of Participants With Decline of ≥2 Points From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status|The ECOG performance status is a scale used to quantify cancer participants' general well-being and activities of daily life. The scale ranges from 0 to 5, with 0 denoting perfect health and 5 indicating death. The 6 categories are 0=Asymptomatic (Fully active, able to carry on all predisease activities without restriction), 1=Symptomatic but completely ambulatory (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature), 2=Symptomatic, < 50% in bed during the day (Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours), 3=Symptomatic, > 50% in bed, but not bedbound (Capable of only limited self-care, confined to bed or chair 50% or more of waking hours), 4=Bedbound (Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair), 5=Death.|Baseline, Day 1 of every Cycle up to Clinical Data Cut (up to 48 months)|Safety population||percentage of participants|||Number
817210|NCT01120184|Secondary|Percentage of Participants With Grade 3-4 Laboratory Parameters|Laboratory results were graded according to NCI CTCAE version 4.0. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activity of daily living with inability to perform bathing, dressing and undressing, feeding self, using the toilet, taking medications but not bedridden. Grade 4: An immediate threat to life. Urgent medical intervention is required in order to maintain survival.|Day 1, 8, and 15 of Cycle 1–3 and on Day 1 of each subsequent cycle up to 50 months from randomization until clinical cutoff of 16-Sept-2014|Safety population. Number of participants analyzed=participants with available data for the outcome.||percentage of participants|||Number
817211|NCT01120184|Secondary|Percentage of Participants With Grade 5 Adverse Events|Adverse events were graded according to NCI CTCAE version 4.0. Grade 5 adverse events are those events which led to death.|Up to 50 months from randomization until clinical cutoff of 16-Sept-2014 (continuously until 28 days after last dose)|Safety population||percentage of participants|||Number
817212|NCT01120184|Secondary|Overall Survival Truncated at 2 Years|Overall Survival truncated at 2 years was defined as the percentage of participants alive at 2 years.|From randomization until 2 years|ITT Population.||percentage of participants|||Number
817213|NCT01120184|Secondary|Percentage of Participants Who Died at 2 Years||From randomization until 2 years|ITT Population||percentage of participants|||Number
817214|NCT01120184|Secondary|Percentage of Participants With Grade ≥3 Adverse Events|Adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activity of daily living with inability to perform bathing, dressing and undressing, feeding self, using the toilet, taking medications but not bedridden. Grade 4: An immediate threat to life. Urgent medical intervention is required in order to maintain survival. Grade 5: Death.|Up to 50 months from randomization until clinical cutoff of 16-Sept-2014 (continuously until 28 days after last dose|Safety Population: All treated participants. Additionally, 2 participants randomized to trastuzumab+taxane received 3 cycles of trastuzumab emtansine and were included in trastuzumab emtansine+placebo arm. 6 participants randomized to trastuzumab emtansine+placebo received pertuzumab and were included in trastuzumab emtansine+pertuzumab arm.||percentage of participants|||Number
817215|NCT01120184|Secondary|One-Year Survival Rate|The percentage of participants alive at 1 year after randomization was estimated as the one-year survival rate using Kaplan-Meier analysis, and corresponding CIs were computed using Greenwood's estimate of the standard error.|From randomization until 1 year|ITT Population.||percentage probability of being alive||95% Confidence Interval|Number
817216|NCT01120184|Secondary|Time to Treatment Failure (TTF)|Treatment failure was defined as the discontinuation of all study medications in the treatment arm for any reason including disease progression, treatment toxicity, death, physician decision, or participant withdrawal. TTF was defined as the time from randomization to treatment failure. Median TTF was estimated using Kaplan-Meier analysis, and corresponding CIs were computed using the Brookmeyer-Crowley method.|Up to 48 months from randomization until clinical cutoff of 16-Sept-2014|ITT Population.||months||95% Confidence Interval|Median
817217|NCT01120184|Secondary|Percentage of Participants Experiencing Treatment Failure|Treatment failure was defined as the discontinuation of all study medications in the treatment arm for any reason including disease progression, treatment toxicity, death, physician decision, or participant withdrawal. The percentage of participants with treatment failure was calculated as [number of participants with event divided by the number analyzed] multiplied by 100.|Up to 48 months from randomization until clinical cutoff of 16-Sept-2014|ITT Population.||percentage of participants|||Number
817218|NCT01120184|Secondary|PFS According to Investigator Assessment|Tumor assessments were performed by the investigator according to RECIST version 1.1. PFS was defined as the time from randomization to first documented disease progression or death from any cause. Disease progression was defined as a ≥20% and 5-mm increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). Median duration of PFS was estimated using Kaplan-Meier analysis, and corresponding CIs were computed using the Brookmeyer-Crowley method.|Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)|ITT Population.||months||95% Confidence Interval|Median
817219|NCT01120184|Secondary|Percentage of Participants With Death or Disease Progression According to Investigator Assessment|Tumor assessments were performed by the investigator according to RECIST version 1.1. Disease progression was defined as a ≥20% and 5-mm increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). The percentage of participants with death or disease progression was calculated as [number of participants with event divided by the number analyzed] multiplied by 100.|Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)|ITT Population.||percentage of participants|||Number
817272|NCT01120236|Secondary|Proportion of Patients Who do Not Achieve a Partial PSA Response|A partial PSA response is considered <= 4 ng/mL|Up to 5 years|One patient from Arm II (androgen deprivation therapy) was ineligible because of lack of a demonstrable radiographic metastasis. This patient was excluded from analyses.||participants|||Number
817222|NCT01120184|Primary|Progression-Free Survival (PFS) According to IRF Assessment|Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. PFS was defined as the time from randomization to first documented disease progression or death from any cause. Disease progression was defined as a ≥20% and 5-mm increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). Median duration of PFS was estimated using Kaplan-Meier analysis, and corresponding confidence intervals (CIs) were computed using the Brookmeyer-Crowley method.|Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)|ITT Population.||months||95% Confidence Interval|Median
817223|NCT01120184|Primary|Percentage of Participants With Death or Disease Progression According to Independent Review Facility (IRF) Assessment|Tumor assessments were performed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. Disease progression was defined as a greater than or equal to (≥) 20 percent (%) and 5-millimeter (mm) increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). The percentage of participants with death or disease progression was calculated as [number of participants with event divided by the number analyzed] multiplied by 100.|Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)|ITT Population.||percentage of participants|||Number
817224|NCT01120197|Secondary|Falls-Efficacy Scale-International|A 16- item self report or interview- based questionnaire assessing the fear of falling during basic and more demanding activities of daily living (Yardley et al. 2005). Each item is scored on a four point scale. Minimun score indicating low concern about falling is 16. The maximun score indication high concern about falling is 64.|Baseline, 3 months follow-up, 12 months follow up||||||
817225|NCT01120197|Secondary|General Health Questionnaire 20 (GHQ20).|GHQ-20 is a generic instrument and registers distress and psychopathology. GHQ-20 is self-administered and the answers to each item may be treated as a “Likert Scale” and have weights assigned to each position (0-1-2-3) where 0 is no distress, and 3 is severe distress. This gives a possible range for the total GHQ-20 score of 0-60. Higher scores indicating poor qol.|At baseline, 3 and 12 months after baseline|||units on a scale||Standard Deviation|Mean
817226|NCT01120197|Secondary|QUALEFFO 41|"Quality of Life Questionnaire issued by the European Foundation for Osteoporosis (QUALEFFO-41), is a disease-specific questionnaire to be used by patients with vertebral fractures attributed to osteoporosis. QUALEFFO-41 is self-administered and contains questions in five domains: pain, ability to perform physical functions, social functioning, general health perception and mental performance. These five domains can be evaluated individually or be represented in a total score. All scores in all the domains are expressed in values ranging from 0-100, where 0 represents the best and 100 the worst. The total QALEFFO score is calculated as a sum of all answers to items and then linearly transformed on the scale 0-100.
High scores indicate poor quality of life."|At baseline, 3 and 12 months after the baseline|||units on a scale||Standard Deviation|Mean
817227|NCT01120197|Secondary|Functional Reach|"The maximum distance in centimetres that can be reached forward in a standing position while maintaining a fixed base of support. Subjects will be instructed to stand sideways against a wall in a natural position and stretch one arm forward level with the shoulder. The position of the third metacarpophalangeal (MCP) joint was taken as the zero point. With the body tilted forward as far as possible, the subjects continued to stretch the arm parallel to the ground.
Amount of cm indicate better balance."|At baseline, 3 and 12 months after the baseline|||Centimetres||Standard Deviation|Mean
817228|NCT01120197|Secondary|Timed Up & Go Test (TUG)|The subject will be instructed to rise from a chair with a seat height of 43 cm, walk 3 m, turn around, return and sit down again, wearing ordinary footwear and use customary walking aids if necessary.|At baseline, 3 and 12 months after the baseline.|||Seconds||Standard Deviation|Mean
817229|NCT01120197|Primary|Time Used to Walk 20 m at Maximal Speed.|Times (measured in seconds) used walking at maximum speed for 20m indoors. No acceleration or deceleration phase used. The type of walking aids used during the test will be recorded. The participants walk as fast as possible wearing their ordinary shoes. The test perform once, the time measured with a stopwatch and the time used on 20 m will be recorded|At baseline, 3 and 12 months after the baseline|||Seconds||Standard Deviation|Mean
817230|NCT01120210|Secondary|Post-baseline Changes Compared to Placebo (at 1-, 2-, and 3-hours Post Infusion Initiation [ie, at the End of 5, 15 and 30 ng/kg/Min Infusions]) in Calculated Systemic Vascular Resistance (SVR)|The primary analysis of this study focused on the differences between the treatment groups in terms of Least Squares (LS) mean change from Baseline at each time point; thus, the results provided below consist of the JNJ-39588146 minus placebo differences in LS means (and associated confidence intervals) for change from Baseline in Calculated Systemic Vascular Resistance (SVR) at the end of 5, 15 and 30 ng/kg/min Infusions as well as treatment group LS means and Standard Errors.|Baseline up through 3 hours post infusion initiation|The modified intent-to-treat (MITT) population included all randomized patients who received at least 1 dose of study drug, had baseline measurement and at least 1 post-baseline measurement value of at least 1 of the primary endpoints. The efficacy analysis was to be performed using the MITT analysis set.||dyn.s.cm-5||Standard Error|Least Squares Mean
817231|NCT01120210|Secondary|Post-baseline Changes Compared to Placebo (at 1-, 2-, and 3-hours Post Infusion Initiation [ie, at the End of 5, 15 and 30 ng/kg/Min Infusions]) in Pulmonary Arterial Diastolic Pressure (PADP)|The primary analysis of this study focused on the differences between the treatment groups in terms of Least Square (LS) mean change from Baseline at each time point; thus, the results provided below consist of the JNJ-39588146 minus placebo differences in LS means (and associated confidence intervals) for change from Baseline in Pulmonary Arterial Diastolic Pressure (PADP) at the end of 5, 15 and 30 ng/kg/min Infusions as well as treatment group LS means and Standard Errors.|Baseline up through 3 hours post infusion initiation|The modified intent-to-treat (MITT) population included all randomized patients who received at least 1 dose of study drug, had baseline measurement and at least 1 post-baseline measurement value of at least 1 of the primary endpoints. The efficacy analysis was to be performed using the MITT analysis set.||mmHg||Standard Error|Least Squares Mean
817232|NCT01120210|Secondary|Post-baseline Changes Compared to Placebo (at 1-, 2-, and 3-hours Post Infusion Initiation [ie, at the End of 5, 15 and 30 ng/kg/Min Infusions]) in Pulmonary Arterial Systolic Pressure (PASP)|The primary analysis of this study focused on the differences between the treatment groups in terms of Least Squares (LS) mean change from Baseline at each time point; thus, the results provided below consist of the JNJ-39588146 minus placebo differences in LS means (and associated confidence intervals) for change from Baseline in Pulmonary Arterial Systolic Pressure (PASP) at the end of 5, 15 and 30 ng/kg/min Infusions as well as treatment group LS means and Standard Errors.|Baseline up through 3 hours post infusion initiation|The modified intent-to-treat (MITT) population included all randomized patients who received at least 1 dose of study drug, had baseline measurement and at least 1 post-baseline measurement value of at least 1 of the primary endpoints. The efficacy analysis was to be performed using the MITT analysis set.||mmHg||Standard Error|Least Squares Mean
817233|NCT01120210|Secondary|Post-baseline Changes Compared to Placebo (at 1-, 2-, and 3-hours Post Infusion Initiation [ie, at the End of 5, 15 and 30 ng/kg/Min Infusions]) in Stroke Volume (SV)|The primary analysis of this study focused on the differences between the treatment groups in terms of Least Squares (LS) mean change from Baseline at each time point; thus, the results provided below consist of the JNJ-39588146 minus placebo differences in LS means (and associated confidence intervals) for change from Baseline in Stroke Volume (SV) at the end of the 30 ng/kg/min infusion as well as treatment group LS means and Standard Errors.|Baseline up through 3 hours post infusion initiation|The modified intent-to-treat (MITT) population included all randomized patients who received at least 1 dose of study drug, had baseline measurement and at least 1 post-baseline measurement value of at least 1 of the primary endpoints. The efficacy analysis was to be performed using the MITT analysis set.||mL/beat||Standard Error|Least Squares Mean
817234|NCT01120210|Secondary|Post-baseline Changes Compared to Placebo (at 3-hours Post Infusion Initiation [ie, at the End of the 30 ng/kg/Min Infusion]) in Fractional Shortening (FS)|The primary analysis of this study focused on the differences between the treatment groups in terms of Least Squares (LS) mean change from Baseline at each time point; thus, the results provided below consist of the JNJ-39588146 minus placebo differences in LS means (and associated confidence intervals) for change from Baseline in Fractional Shortening (FS) at the end of the 30 ng/kg/min infusion as well as treatment group LS means and Standard Errors.|Baseline up through 3 hours post infusion initiation|The modified intent-to-treat (MITT) population included all randomized patients who received at least 1 dose of study drug, had baseline measurement and at least 1 post-baseline measurement value of at least 1 of the primary endpoints. The efficacy analysis was to be performed using the MITT analysis set.||percentage||Standard Error|Least Squares Mean
817235|NCT01120210|Secondary|Post-baseline Changes Compared to Placebo (at 3-hours Post Infusion Initiation [ie, at the End of the 30 ng/kg/Min Infusion]) in Left Ventricular Ejection Fraction (LVEF)|The primary analysis of this study focused on the differences between the treatment groups in terms of Least Squares (LS) mean change from Baseline at each time point; thus, the results provided below consist of the JNJ-39588146 minus placebo differences in LS means (and associated confidence intervals) for change from Baseline in Left Ventricular Ejection Fraction (LVEF) at the end of the 30 ng/kg/min infusion as well as treatment group LS means and Standard Errors.|Baseline up through 3 hours post infusion initiation|The modified intent-to-treat (MITT) population included all randomized patients who received at least 1 dose of study drug, had baseline measurement and at least 1 post-baseline measurement value of at least 1 of the primary endpoints. The efficacy analysis was to be performed using the MITT analysis set.||percentage||Standard Error|Least Squares Mean
817236|NCT01120210|Secondary|Post-baseline Changes Compared to Placebo (at 3-hours Post Infusion Initiation [ie, at the End of 30 ng/kg/Min Infusion]) in Left Ventricular End Diastolic Volume (LVEDV)|The primary analysis of this study focused on the differences between the treatment groups in terms of Least Squares (LS) mean change from Baseline at each time point; thus, the results provided below consist of the JNJ-39588146 minus placebo differences in LS means (and associated confidence intervals) for change from Baseline in Left Ventricular End Diastolic Volume (LVEDV) at the end of the 30 ng/kg/min infusion as well as treatment group LS means and Standard Errors.|Baseline up through 3 hours post infusion initiation|The modified intent-to-treat (MITT) population included all randomized patients who received at least 1 dose of study drug, had baseline measurement and at least 1 post-baseline measurement value of at least 1 of the primary endpoints. The efficacy analysis was to be performed using the MITT analysis set.||mL||Standard Error|Least Squares Mean
817237|NCT01120210|Secondary|Post-baseline Changes Compared to Placebo (at 3-hours Post Infusion Initiation [ie, at the End of the 30 ng/kg/Min Infusion]) in Left Ventricular End Systolic Volume (LVESV)|The primary analysis of this study focused on the differences between the treatment groups in terms of Least Squares (LS) mean change from Baseline at each time point; thus, the results provided below consist of the JNJ-39588146 minus placebo differences in LS means (and associated confidence intervals) for change from Baseline in left ventricular end systolic volume (LVESV) at the end of the 30 ng/kg/min infusion as well as treatment group LS means and Standard Errors.|Baseline up through 3 hours post infusion initiation|The modified intent-to-treat (MITT) population included all randomized patients who received at least 1 dose of study drug, had baseline measurement and at least 1 post-baseline measurement value of at least 1 of the primary endpoints. The efficacy analysis was to be performed using the MITT analysis set.||mL||Standard Error|Least Squares Mean
817238|NCT01120210|Secondary|Post-baseline Changes Compared to Placebo (at 1-, 2-, and 3-hours Post Infusion Initiation [ie, at the End of 5, 15 and 30 ng/kg/Min Infusions]) in Diastolic Blood Pressure (DBP)|The primary analysis of this study focused on the differences between the treatment groups in terms of LS mean change from Baseline at each time point; thus, the results provided below consist of the JNJ-39588146 minus placebo differences in Least Square (LS) means (and associated confidence intervals) for change from Baseline in diastolic blood pressure(DBP) at each time point as well as treatment group LS means and Standard Errors.|Baseline up through 3 hours post infusion initiation|The modified intent-to-treat (MITT) population included all randomized patients who received at least 1 dose of study drug, had baseline measurement and at least 1 post-baseline measurement value of at least 1 of the primary endpoints. The efficacy analysis was to be performed using the MITT analysis set.||mmHg||Standard Error|Least Squares Mean
817948|NCT01123980|Secondary|Number of Hypoglycaemic Episodes|All episodes classified into nocturnal (time of onset between 00:00 (included) and 05:59 (included)).|Weeks 0-24|The safety analysis set contains all subjects exposed to at least one dose of investigational product(s).||episodes|||Number
817239|NCT01120210|Secondary|Post-baseline Changes Compared to Placebo (at 1-, 2-, and 3-hours Post Infusion Initiation [ie, at the End of 5, 15 and 30 ng/kg/Min Infusions]) in Systolic Blood Pressure (SBP)|The primary analysis of this study focused on the differences between the treatment groups in terms of Least Squares (LS) mean change from Baseline at each time point; thus, the results provided below consist of the JNJ-39588146 minus placebo differences in LS means (and associated confidence intervals) for change from Baseline in systolic blood pressure (SBP) at each time point as well as treatment group LS means and Standard Errors.|Baseline up through 3 hours post infusion initiation|The modified intent-to-treat (MITT) population included all randomized patients who received at least 1 dose of study drug, had baseline measurement and at least 1 post-baseline measurement value of at least 1 of the primary endpoints. The efficacy analysis was to be performed using the MITT analysis set.||mmHg||Standard Error|Least Squares Mean
817240|NCT01120210|Secondary|Post-baseline Changes Compared to Placebo (at 1-, 2-, and 3-hours Post Infusion Initiation [ie, at the End of 5, 15 and 30 ng/kg/Min Infusions]) in Heart Rate (HR)|The primary analysis of this study focused on the differences between the treatment groups in terms of Least Squares (LS) mean change from Baseline at each time point; thus, the results provided below consist of the JNJ-39588146 minus placebo differences in LS means (and associated confidence intervals) for change from Baseline in heart rate (HR) at each time point as well as treatment group LS means and Standard Errors.|At 1-hour, 2 hours and 3 hours post infusion initiation|The modified intent-to-treat (MITT) population included all randomized patients who received at least 1 dose of study drug, had baseline measurement and at least 1 post-baseline measurement value of at least 1 of the primary endpoints. The efficacy analysis was to be performed using the MITT analysis set.||beats per minute (bpm)||Standard Error|Least Squares Mean
817241|NCT01120210|Primary|Post-baseline Changes Compared to Placebo (at 1-, 2-, and 3-hours Post Infusion Initiation [ie, at the End of 5, 15 and 30 ng/kg/Min Infusions]) in Pulmonary Capillary Wedge Pressure (PCWP)|The effect of JNJ-39588146 on pulmonary capillary wedge pressure (PCWP) was evaluated by administering multiple ascending doses of JNJ-39588146 or placebo over a 3-hour intravenous (IV) infusion period to patients with heart failure. The primary analysis of this study focused on the differences between the treatment groups in terms of Least Squares (LS) mean change from Baseline at each time point; thus, the results provided below consist of the JNJ-39588146 minus placebo differences in LS means (and associated confidence intervals) for change from baseline in PCWP at each time point as well as treatment group LS means and Standard Errors.|Baseline up through 3 hours post infusion initiation|The modified intent-to-treat (MITT) population included all randomized patients who received at least 1 dose of study drug, had baseline measurement and at least 1 post-baseline measurement value of at least 1 of the primary endpoints. The efficacy analysis was to be performed using the MITT analysis set.||mmHg||Standard Error|Least Squares Mean
817242|NCT01120210|Primary|Post-baseline Changes Compared to Placebo (at 1-, 2-, and 3-hours Post Infusion Initiation [ie, at the End of 5, 15 and 30 ng/kg/Min Infusions]) in Cardiac Index (CI)|The effect of JNJ-39588146 on cardiac index (CI), a hemodynamic parameter that relates heart performance to the size of the individual measured in liters per minute per square metre (l/min/m2) was evaluated in patients with heart failure (HF). The primary analysis of this study focused on the differences between the treatment groups in terms of Least Squares (LS) mean change from Baseline at each time point; thus, the results provided below consist of the JNJ-39588146 minus placebo differences in LS means (and associated confidence intervals) for change from Baseline in CI at each time point as well as treatment group LS means and Standard Errors.|Baseline up through 3 hours post infusion initiation|The modified intent-to-treat (MITT) population included all randomized patients who received at least 1 dose of study drug, had baseline measurement and at least 1 post-baseline measurement value of at least 1 of the primary endpoints. The efficacy analysis was to be performed using the MITT analysis set.||L/min/m2||Standard Error|Least Squares Mean
817243|NCT01120223|Secondary|Withdrawal|"How many subjects withdrew from the study. Reasons for withdrawal:
due to exclusion criteria emerging, due to AE(s), or due to other reason"|Week 4 and 8|||participants|||Number
817244|NCT01120223|Secondary|Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient’s Global Assessment of Disease Severity at End of Treatment|Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient’s Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation.|End of treatment (up to 8 weeks)|||participants|||Number
817245|NCT01120223|Secondary|Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient’s Global Assessment of Disease Severity at Week 8|Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient’s Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation.|Week 8|||participants|||Number
817246|NCT01120223|Secondary|Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient’s Global Assessment of Disease Severity at Week 4|Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient’s Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation.|Week 4|||participants|||Number
817247|NCT01120223|Secondary|Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient’s Global Assessment of Disease Severity at Week 2|Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient’s Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation. The scale: 1 = clear, 2 = very mild, 3 = mild, 4 = moderate, 5 = severe.|Week 2|||participants|||Number
817248|NCT01120223|Secondary|Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to End of Treatment.|Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score (ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 (best possible outcome) to 12 points (worst possible outcome).|Baseline and End of treatment (up to 8 weeks)|||percent of change||Standard Deviation|Mean
817370|NCT01120990|Primary|Systolic Blood Pressure Measured by Tested Device.|Mean Systolic Blood pressure value of all BP measurements made by the tested device in all patients included in the analysis.|3 months|According to the European Society of Hypertension International Protocol 2010, recruitment is continued until 33 subjects that meet the entry criteria complete all the measurements.||mmHg||Standard Deviation|Mean
817249|NCT01120223|Secondary|Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to Week 8|Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score (ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 (best possible outcome) to 12 points (worst possible outcome).|Baseline and week 8|||percent change||Standard Deviation|Mean
817250|NCT01120223|Secondary|Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to Weeks 4|Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score (ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 to 12 points.|Baseline and week 4|||percent of change||Standard Deviation|Mean
817251|NCT01120223|Secondary|Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness)From Baseline to Week 2|Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score (ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 (best possible outcome) to 12 points (worst possible outcome).|Baseline and week 2|||percentage of change||Standard Deviation|Mean
817252|NCT01120223|Secondary|Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator’s Global Assessment (IGA) of Disease Severity at End of Treatment|Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation at end of treatment|End of treatment (up to 8 weeks)|||participants|||Number
817253|NCT01120223|Primary|Change in Urinary Calcium:Creatinine Ratio From Baseline to End of Treatment|Change in urinary calcium:creatinine ratio from Baseline to end of treatment|Baseline and End of treatment (up to 8 weeks)|||mmol/g||Standard Deviation|Mean
817254|NCT01120223|Primary|Change in Urinary Calcium:Creatinine Ratio From Baseline to Week 8|Change in urinary calcium:creatinine ratio from Baseline to week 8|Baseline and week 8|||mmol/g||Standard Deviation|Mean
817255|NCT01120223|Primary|Change in Urinary Calcium:Creatinine Ratio From Baseline to Week 4|Change in urinary calcium:creatinine ratio from Baseline to week 4|Baseline and week 4|||mmol/g||Standard Deviation|Mean
817256|NCT01120223|Primary|Change in 24-hour Urinary Calcium Excretion From Baseline to End of Treatment|Change in 24-hour urinary calcium excretion from Baseline to end of treatment|Baseline and End of treatment (up to 8 weeks)|||mmol/24hr||Standard Deviation|Mean
817257|NCT01120223|Primary|Change in 24-hour Urinary Calcium Excretion From Baseline to Week 8|Change in 24-hour urinary calcium excretion from Baseline to week 8|Baseline and week 8|||mmol/24hr||Standard Deviation|Mean
817258|NCT01120223|Primary|Change in 24-hour Urinary Calcium Excretion From Baseline to Week 4|Change in 24-hour urinary calcium excretion from Baseline to week 4|Baseline and week 4|||mmol/24hr||Standard Deviation|Mean
817259|NCT01120223|Primary|Change in Albumincorrected Serum Calcium From Baseline to End of Treatment|Change in albumincorrected serum calcium from Baseline to end of treatment|Baseline and End of treatment (up to 8 weeks)|||mmol/L||Standard Error|Mean
817260|NCT01120223|Secondary|Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator’s Global Assessment (IGA) of Disease Severity at Week 8|Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation at week 8|Week 8|||participants|||Number
817261|NCT01120223|Secondary|Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator’s Global Assessment (IGA) of Disease Severity at Week 4|Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation at week 4|Week 4|||participants|||Number
817262|NCT01120223|Secondary|Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator’s Global Assessment (IGA) of Disease Severity at Week 2|Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation at week 2. The IGA Scale: 1 = clear, 2 = almost clear, 3 = mild, 4 = moderate, 5 = severe, and 6 = very severe.|Week 2|||participants|||Number
817263|NCT01120223|Secondary|Change in Plasma PTH From Baseline to Week 8|Change in plasma PTH (parathyroid hormone) from Baseline to week 8|Baseline and week 8|||ng/L||Standard Deviation|Mean
817264|NCT01120223|Secondary|Change in Plasma PTH From Baseline to Week 4|Change in plasma PTH (parathyroid hormone) from Baseline to week 4|Baseline and week 4|||ng/L||Standard Deviation|Mean
817265|NCT01120223|Primary|Change in Albumincorrected Serum Calcium From Baseline to Week 8|Change in albumincorrected serum calcium from Baseline to week 8|Baseline and week 8|||mmol/L||Standard Deviation|Mean
817266|NCT01120223|Primary|Change in Albumincorrected Serum Calcium From Baseline to Week 4|Change in albumincorrected serum calcium from Baseline to week 4|Baseline and week 4|||mmol/L||Standard Deviation|Mean
817267|NCT01120223|Primary|Percentage of Subjects With Adverse Drug Reactions (ADRs)|Adverse events for which the investigator did not describe the causal relationship to IP as not related|Throughout trial, up to 8-weeks|||percent subjects|||Number
817268|NCT01120236|Other Pre-specified|Change in microRNA Measures|Pearson and Spearman correlations will be initially evaluated between microRNA measures and CTC counts. Analysis of covariance will be used to assess the relationship between microRNA and CTC, after adjusting for stratification factors.|Baseline to 12 weeks||||||
817269|NCT01120236|Other Pre-specified|Change in Level of CTCs|Will be correlated with undetectable PSA and normalized PSA response.|Baseline to 12 weeks||||||
817270|NCT01120236|Other Pre-specified|Change in Level of Serum Biomarkers||Baseline to 12 weeks||||||
818141|NCT01125202|Primary|Time Specific Interdialytic Weight Gain (12 Weeks)|Average interdialytic weight gains (kg/day) were calculated for the 1 week period prior to the 12 week measurement time point.|12 weeks|Some participants have missing interdialytic weight gains due to missed hemodialysis treatments.||kg/day||Standard Deviation|Mean
817273|NCT01120236|Secondary|Toxicity|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Up to 28 weeks|All participants receiving at least some protocol treatment were included in toxicity analysis. Four patients on Arm I (androgen deprivation and cixutumumab) and two patients on Arm II (androgen deprivation therapy) did not receive any protocol treatment and were therefore excluded from this analysis.||Participants|||Number
817274|NCT01120236|Primary|Undetectable PSA Rate|Undetectable PSA rate (<= 0.2 ng/mL) after seven cycles (28 weeks) of protocol treatment|7 months|One patient from Arm II (androgen deprivation therapy) was ineligible because of lack of a demonstrable radiographic metastasis. This patient was excluded from analyses.||participants|||Number
817275|NCT01120275|Secondary|Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs|Adverse Events (AEs) are reported by CTCAE version 4.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.|Toxicity assessment was evaluated at least every 3 weeks at the beginning of each cycle, up to 3 years|Eligible patients who had received the protocol treatments were included in the adverse event summaries. Any CTCAE 4.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.||Participants|||Number
817276|NCT01120275|Secondary|Percentage of Participants With Confirmed and Unconfirmed Complete or Partial Response|Complete disappearance of all measurable and non-measurable disease, or greater than or equal to 30% decrease under baseline of the sum of the longest diameters of all target measurable lesions.|Disease assessments for response were performed every 6 weeks, up to 3 years|||portation of participants||95% Confidence Interval|Number
817277|NCT01120275|Primary|Overall Survival|From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Weekly, up to 3 years.|||Months||95% Confidence Interval|Median
817278|NCT01120275|Primary|Progression-free Survival According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1|From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause.|Disease assessments were performed every 6 weeks, up to 3 years.|||Months||95% Confidence Interval|Median
817279|NCT01120379|Secondary|Dual Antiplatelet Medication Usage|Patient is included if medications (both aspirin and thienopyridine) were taken for at least 1 day during the visit window. The visit window for 4-year visit is 1502 days.|4 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.||percentage of participants|||Number
817280|NCT01120379|Secondary|Dual Antiplatelet Medication Usage|Patient is included if medications (both aspirin and thienopyridine) were taken for at least 1 day during the visit window. The visit window for 3-year visit is 1053-1137 days.|3 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.||percentage of participants|||Number
817281|NCT01120379|Secondary|Dual Antiplatelet Medication Usage|Patient is included if medications (both aspirin and thienopyridine) were taken for at least 1 day during the visit window. The visit window for 2-year visit is 688-772 days.|2 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.||percentage of participants|||Number
817282|NCT01120379|Secondary|Major Bleeding Complications|Major bleeding complications consisted of CEC-adjudicated TIMI major bleeding through 2-year follow-up and site reported major bleeding after 2 years.|4 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.||percentage of participants||95% Confidence Interval|Number
817283|NCT01120379|Secondary|Major Bleeding Complications (Site Reported)|Major bleeding complications consisted of CEC-adjudicated TIMI major bleeding through 2-year follow-up and site reported major bleeding after 2 years.|3 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.||percentage of participants||95% Confidence Interval|Number
817284|NCT01120379|Secondary|Major Bleeding Complications|Major bleeding complications consisted of Clinical Events Committee (CEC)-adjudicated Thrombolysis In Myocardial Infarction (TIMI) major bleeding through 2-year follow-up and site reported major bleeding after 2 years.|2 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.||percentage of participants||95% Confidence Interval|Number
817285|NCT01120379|Secondary|Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG)||4 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.||percentage of participants||95% Confidence Interval|Number
817286|NCT01120379|Secondary|Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG)||3 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.||percentage of participants||95% Confidence Interval|Number
817287|NCT01120379|Secondary|Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG)||2 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.||percentage of participants||95% Confidence Interval|Number
817288|NCT01120379|Secondary|Any MI (Q-wave and Non Q-wave)||4 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.||percentage of participants||95% Confidence Interval|Number
817289|NCT01120379|Secondary|Any MI (Q-wave and Non Q-wave)||3 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.||percentage of participants||95% Confidence Interval|Number
817290|NCT01120379|Secondary|Any MI (Q-wave and Non Q-wave)||2 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.||percentage of participants||95% Confidence Interval|Number
817291|NCT01120379|Secondary|Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death)||4 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.||percentage of participants||95% Confidence Interval|Number
817292|NCT01120379|Secondary|Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death)||3 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.||percentage of participants||95% Confidence Interval|Number
817293|NCT01120379|Secondary|Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death)||2 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.||percentage of participants||95% Confidence Interval|Number
817294|NCT01120379|Secondary|Composite Rate of Cardiac Death and MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Clinically-indicated Target Lesion Revascularization (CI-TLR) (PCI and CABG) (This Composite Endpoint is Also Denoted as TLF)||4 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.||percentage of participants||95% Confidence Interval|Number
817295|NCT01120379|Secondary|Composite Rate of Cardiac Death and MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Clinically-indicated Target Lesion Revascularization (CI-TLR) (PCI and CABG) (This Composite Endpoint is Also Denoted as TLF)||3 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.||percentage of participants||95% Confidence Interval|Number
817296|NCT01120379|Secondary|Composite Rate of Cardiac Death and MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Clinically-indicated Target Lesion Revascularization (CI-TLR) (PCI and CABG) (This Composite Endpoint is Also Denoted as TLF)||2 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.||percentage of participants||95% Confidence Interval|Number
817297|NCT01120379|Secondary|Composite Rate of Cardiac Death, Any MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Target Lesion Revascularization (TLR) (PCI and CABG)||4 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.||percentage of participants||95% Confidence Interval|Number
817298|NCT01120379|Secondary|Composite Rate of Cardiac Death, Any MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Target Lesion Revascularization (TLR) (PCI and CABG)||3 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.||percentage of participants||95% Confidence Interval|Number
817299|NCT01120379|Secondary|Composite Rate of Cardiac Death, Any MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Target Lesion Revascularization (TLR) (PCI and CABG)||2 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.||percentage of participants||95% Confidence Interval|Number
819837|NCT01138475|Secondary|Serum 25 OH Vitamin D|This secondary outcome measure is change in serum hydroxy-vitaminD from baseline to final measure at 6 weeks differences in the 3 arms were compared|6 weeks|missing data from participant in paricalcitrol arm||ng/dL||Standard Deviation|Mean
817300|NCT01120379|Secondary|Composite Rate of All Death, Any MI (Q-wave and Non Q-wave) and Any Repeat Revascularization (Percutaneous Coronary Intervention [PCI] and Coronary Artery Bypass Graft [CABG]||4 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.||percentage of participants||95% Confidence Interval|Number
817301|NCT01120379|Secondary|Composite Rate of All Death, Any MI (Q-wave and Non Q-wave) and Any Repeat Revascularization (Percutaneous Coronary Intervention [PCI] and Coronary Artery Bypass Graft [CABG]||3 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.||percentage of participants||95% Confidence Interval|Number
817302|NCT01120379|Secondary|Composite Rate of All Death, Any MI (Q-wave and Non Q-wave) and Any Repeat Revascularization (Percutaneous Coronary Intervention [PCI] and Coronary Artery Bypass Graft [CABG]||2 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.||percentage of participants||95% Confidence Interval|Number
817303|NCT01120379|Secondary|Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)||4 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.||percentage of participants||95% Confidence Interval|Number
817304|NCT01120379|Secondary|Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)||3 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.||percentage of participants||95% Confidence Interval|Number
817305|NCT01120379|Secondary|Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)||2 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.||percentage of participants||95% Confidence Interval|Number
817306|NCT01120379|Primary|Composite Rate of Cardiac Death and Any Myocardial Infarction (ARC Defined).||4 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.||percentage of participants||95% Confidence Interval|Number
817307|NCT01120379|Primary|Composite Rate of Cardiac Death and Any Myocardial Infarction (ARC Defined).||3 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.||percentage of participants||95% Confidence Interval|Number
817308|NCT01120379|Primary|Composite Rate of Cardiac Death and Any Myocardial Infarction [MI] (ARC Defined).||2 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.||percentage of participants||95% Confidence Interval|Number
817309|NCT01120379|Primary|Stent Thrombosis (Definite and Probable) as Defined by ARC|Stent thrombosis was defined by ARC criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation), or very late (>1 year post stent implantation).|4 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.||percentage of participants||95% Confidence Interval|Number
817322|NCT01120405|Secondary|Number of Participants With Cardiac Troponin I or T Above the 99th Percentile (Local Laboratories)|At least 1 value of serum cardiac troponin I or T above the 99th percentile (measurements performed by local laboratories using different techniques)|3 Postoperative days|Full analysis set (FAS): Randomised patients who started general anaesthesia induction. Patients were assigned to the treatment groups as randomised, i.e. the treatment groups were based on the treatment allocated by randomisation.||participants|||Number
817323|NCT01120405|Primary|Number of Participants With Myocardial Necrosis (MN)|Myocardial Necrosis: at least 1 value of serum cardiac troponin I above the 99th percentile (measurement performed by a central laboratory using the ABBOTT-ARCHITECT technique)|3 Postoperative Days|Per protocol set (PPS): Randomised patients who started general anaesthesia induction and with no major protocol violations. Patients were assigned to the treatment groups as randomised, i.e. the treatment groups were based on the treatment allocated by randomisation.||participants|||Number
817310|NCT01120379|Primary|Stent Thrombosis (Definite and Probable) Rate as Defined by ARC (Academic Research Consortium)|Stent thrombosis was defined by ARC criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation), or very late (>1 year post stent implantation).|3 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.||percentage of participants||95% Confidence Interval|Number
817311|NCT01120379|Primary|Stent Thrombosis (Definite and Probable) Rate as Defined by ARC (Academic Research Consortium)|Stent thrombosis was defined by ARC criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation), or very late (>1 year post stent implantation).|2 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.||percentage of participants||95% Confidence Interval|Number
817312|NCT01120405|Secondary|Urine Output|Urine volume in milliliter (mL) during the first postoperative hours|From Day 0 until Postoperative Day 1|Treated set (TS): Randomised patients who received the study medication. Patients were assigned to the treatment groups as treated, i.e. the treatment groups were based on the treatment actually received.||mL||Standard Deviation|Mean
817313|NCT01120405|Secondary|Number of Participants With Chest Pain During the 3 Postoperative Days|Patients with Chest Pain reported at least once per day during the 3 Postoperative Days|From Day 0 until Postoperative Day 3|Treated set (TS): Randomised patients who received the study medication. Patients were assigned to the treatment groups as treated, i.e. the treatment groups were based on the treatment actually received.||participants|||Number
817314|NCT01120405|Secondary|Vital Signs (Heart Rate Changes)|Changes from baseline for Heart Rate (HR)|From pre-induction to Postoperative Day 3|Treated set (TS): Randomised patients who received the study medication. Patients were assigned to the treatment groups as treated, i.e. the treatment groups were based on the treatment actually received.||beats per minute||Standard Deviation|Mean
817315|NCT01120405|Secondary|Vital Signs (SBP and DBP Changes)|Changes from baseline for Systolic and Diastolic Blood Pressure (SBP and DBP)|From pre-induction to Postoperative Day 3|Treated set (TS): Randomised patients who received the study medication. Patients were assigned to the treatment groups as treated, i.e. the treatment groups were based on the treatment actually received.||mm Hg||Standard Deviation|Mean
817316|NCT01120405|Secondary|Systolic Blood Pressure (SBP)|Repeated Systolic Blood Pressure measurements during the perioperative period|From pre-induction to recovery of anesthesia|Full analysis set (FAS): Randomised patients who started general anaesthesia induction. Patients were assigned to the treatment groups as randomised, i.e. the treatment groups were based on the treatment allocated by randomisation.||mm Hg||Standard Deviation|Mean
817317|NCT01120405|Secondary|Number of Participants With Composite Endpoint|Patients with at least 1 event among MN assessed by central laboratory, MI, Cerebro-Vascular event, Life-Threatening Arrhythmia and Death from Cardiac Origin|3 postoperative days|Full analysis set (FAS): Randomised patients who started general anaesthesia induction. Patients were assigned to the treatment groups as randomised, i.e. the treatment groups were based on the treatment allocated by randomisation.||participants|||Number
817318|NCT01120405|Secondary|Number of Participants Who Died From Cardiac Origin|No patient died from a cardiac cause during the 3 postoperative days.|3 postoperative days|Full analysis set (FAS): Randomised patients who started general anaesthesia induction. Patients were assigned to the treatment groups as randomised, i.e. the treatment groups were based on the treatment allocated by randomisation.||participants|||Number
817319|NCT01120405|Secondary|Number of Participants With Life-Threatening Arrhythmia|Patients with Life-Threatening Arrhythmia in the FAS|3 Postoperative Days|Full analysis set (FAS): Randomised patients who started general anaesthesia induction. Patients were assigned to the treatment groups as randomised, i.e. the treatment groups were based on the treatment allocated by randomisation.||participants|||Number
817320|NCT01120405|Secondary|Number of Participants With Cerebro-Vascular Event|Patients with Cerebro-Vascular Event in the FAS|3 postoperative days|Full analysis set (FAS): Randomised patients who started general anaesthesia induction. Patients were assigned to the treatment groups as randomised, i.e. the treatment groups were based on the treatment allocated by randomisation.||participants|||Number
817321|NCT01120405|Secondary|Number of Participants With Myocardial Infarction (MI)|Patients with Confirmed Myocardial Infarction (MI) by the Investigators|3 Postoperative Days|Full analysis set (FAS): Randomised patients who started general anaesthesia induction. Patients were assigned to the treatment groups as randomised, i.e. the treatment groups were based on the treatment allocated by randomisation.||participants|||Number
818142|NCT01125202|Primary|Time Specific Interdialytic Weight Gain (8 Weeks)|Average interdialytic weight gains (kg/day) were calculated for the 1 week period prior to the 8-week measurement time point.|8 weeks|Some participants have missing interdialytic weight gains due to missed hemodialysis treatments.||kg/day||Standard Deviation|Mean
817324|NCT01120626|Secondary|Aberrant Behavior Checklist (ABC)|The Aberrant Behavior Checklist is a 58-item symptom checklist for assessing problem behaviors. The ABC was rated by each participant's parent. Each item is rated on a four-point Likert scale ranging from 0 (not at all a problem) to 3 (the problem is severe in degree). The ABC Total score (range 0-174) is the sum of all individual item scores. Higher score indicates more maladaptive behaviors/worse outcome.|Week 12|41 of 42 randomized participants completed the 12-week randomized controlled trial. 39 of 42 participants were administered the ABC at week 12.||units on a scale||Standard Deviation|Mean
817325|NCT01120626|Primary|Contingency Naming Test (CNT) Performance Score|Week 12 Contingency Naming Test (CNT) performance score on Rule 2 (naming shapes) and on Rule 3 (If the inside shape matches the outside shape, name the color, otherwise, name the outside shape). Performance score is the number of correct responses per minute, calculated by dividing the number of correct responses by the time taken to complete the 27 items, and multiplying by 60. Higher scores indicate faster and more accurate responding.|Week 12|41 of 42 randomized participants completed the 12-week randomized controlled trial. 37 of 42 randomized participants completed CNT Rule 2 at week 12. 34 of 42 randomized participants completed CNT Rule 3 at week 12.||correct responses per minute||Standard Deviation|Mean
817326|NCT01120691|Secondary|St. George's Respiratory Questionnaire (SGRQ) Scores Between QVA149, NVA237 and Open Label Tiotropium Over 12, 26, 38, 52 and 64 Weeks of Treatment|St. George's Respiratory Questionnaire (SGRQ) is a health related quality of life questionnaire consisting of 51 items in three components: symptoms, activity, and impacts. The lowest possible value is zero and the highest 100. Higher values correspond to greater impairment in quality of life. Mixed model used baseline SGRQ, baseline inhaled corticosteroid (ICS) use, Forced Expiratory Volume in 1 Second (FEV1) prior to inhalation of short acting beta-agonist (SABA), and FEV1 45 minutes post-inhalation of SABA as covariates. SGRQ total score is the sum of the scores from the three components; symptoms, activity and impacts.|12, 26, 38, 52 and 64 weeks|Modified Full Analysis Set (mFAS) included all patients in the Full analysis set except patients from a site, which had major issues with GCP compliance. The Full Analysis Set (FAS) includes all randomized patients who received at least one dose of study drug and data was available for analysis.||units on a scale||Standard Error|Least Squares Mean
817327|NCT01120691|Secondary|Change From Baseline of Percentage of Days Without Rescue Therapy Use Between QVA149,NVA237 and Open Label Tiotropium Over the 64 Week Treatment Period|A day with no rescue medication use is defined from the diary data as any day where the patient recorded no rescue medicine use during the previous 12 hours. The percentage of days is calculated by the number of days with no rescue medicine use/total number of days with evaluable data X 100. A mixed model was used with treatment as a fixed effect with baseline number of puffs and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.|Baseline (14 day run-in), 64 weeks|Modified Full Analysis Set(mFAS)included all patients in the Full analysis set except patients from a site,which had major issues with GCP compliance. The Full Analysis Set includes all randomized patients who received at least one dose of study drug and data was available for analysis. Patients with evaluable data were included in this analysis||percentage of days||Standard Error|Least Squares Mean
817328|NCT01120691|Secondary|Change in Mean Daily Use (Number of Puffs) of Rescue Therapy Between QVA149, NVA237 and Open Label Tiotropium From Baseling Over the 64 Week Treatment Period|The severe or less FEV1 % predicted (post bronchodilator)>=30%; very severe=> FEV1 % predicted(the post bronchodilator)<30%.Number of puffs of rescue medication taken in the previous 12 hours was recorded in patient diary in the morning and in the evening for 26 weeks.The total number of puffs per day was calculated and divided by the number of days with data to determine the mean daily number of puffs of rescue medication for each patient.Rescue medication data recorded during the 14 day run-in was used to calculate the baseline.A negative change from baseline indicates improvement. A mixed model was used with treatment as a fixed effect with baseline number of puffs and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates.|Baseline (14 day run-in), 64 weeks|Modified Full Analysis Set mFAS included all patients in the Full analysis set except patients from a site,which had major issues with GCP compliance. The Full Analysis Set includes all randomized patients who received at least one dose of study drug and data was available for analysis. Patients with evaluable data were included in this analysis||# puffs||Standard Error|Least Squares Mean
817329|NCT01120691|Secondary|Pre-dose Forced Vital Capacity (FVC)After 4, 12, 26, 38, 52 and 64 Weeks of Treatment Between QVA149, NVA237 and Open Label Tiotropium|"Pulmonary function assessments were performed using centralized spirometry. The spirometer was customized and programmed according to the requirements of the study protocol in accordance with American Thoracic Society (ATS) standards.
Pre-dose Forced Vital Capacity (FVC) is defined as the average of the -15 minutes and the -45 minutes FVC values. Baseline is defined as the average of the -45 minutes and -15 minutes FVC values taken on day 1 prior to first dose. FVC data taken within 6h of rescue medication or within 7 days of systemic corticosteroid is excluded from this analysis"|4, 12, 26, 38, 52 and 64 weeks|Modified Full Analysis Set(mFAS) included all patients in the Full Analysis Set (FAS) except patients from a site, which had major issues with GCP compliance. FAS include all randomized patients who received at least one dose of study drug and data was available for analysis. Each category has patients with assessable data at that particular time.||L (liters)||Standard Error|Least Squares Mean
817346|NCT01120717|Primary|Number of Participants With Adverse Events, Serious Adverse Events or Death|Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal lab finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgments of the investigators represent significant hazards.|52 weeks + Follow-up (Up to Day 394)|Safety population - all patients who received at least one dose of study drug whether or not they were randomized. Only patients with safety assessments were included in this analysis.||participants|||Number
817330|NCT01120691|Secondary|Pre-dose Forced Expiratory Volume in 1 Second (FEV-1) After 4, 12, 26, 38, 52 and 64 Weeks of Treatment Between QVA149, NVA237 and Open Label Tiotropium|"Pulmonary function assessments were performed using centralized spirometry. The spirometer was customized and programmed according to the requirements of the study protocol in accordance with American Thoracic Society (ATS) standards.
Spirometry measurements taken were FEV1 at -45 minutes and -15 minutes pre-dose. Three acceptable maneuvers had to be performed for each time point. The FEV1 values recorded had to be the highest values measured irrespective of whether or not they occurred on the same curve.
The mixed model for analysis contained treatment as a fixed effect with average of the 45 minutes and 15 minutes pre dose FEV1 measurements at day 1 as the baseline measurement, FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at -14 Day) as covariates."|4, 12, 26, 38, 52 and 64 weeks|Modified Full Analysis Set(mFAS) included all patients in the Full Analysis Set (FAS) except patients from a site, which had major issues with GCP compliance. FAS include all randomized patients who received at least one dose of study drug and data was available for analysis. Each category has patients with assessable data at that particular time.||L (liters)||Standard Error|Least Squares Mean
817331|NCT01120691|Secondary|Cumulative Rates of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations for Multiple COPD Exacerbation at Different Time Points|Cumulative rates were estimated using Anderson and Gill method. Chronic Obstructive Pulmonary Disease (COPD) exacerbations are considered to be moderate if treatment with systemic corticosteroids and/or antibiotics was required. COPD exacerbations are considered to be severe if treatment for moderate severity and hospitalization were required. Rate of moderate or severe exacerbations per year = total number of moderate or severe exacerbations / total number of treatment years|26, 52, 64, 76 weeks|Modified Full Analysis Set(mFAS) included all patients in the Full Analysis Set (FAS) except patients from a site, which had major issues with GCP compliance. FAS include all randomized patients who received at least one dose of study drug and data was available for analysis.||exacerbations per year|Participants|95% Confidence Interval|Number
817332|NCT01120691|Secondary|Percentage of Patients With Study Withdrawal or Premature Discontinuation for Any Reason Between QVA149 (110/50 µg q.d.), NVA237 (50 µg q.d.) and Open Label Tiotropium (18 µg q.d.)During the Treatment Period|Percentage of Patients With Study Withdrawal or Premature Discontinuation for Any Reason was analyzed for each treatment group using a Kaplan-Meier estimation for the modified safety set. Patients who did not discontinue early were censored at the final visit of the treatment phase.|64 weeks|Modified safety set (mSAF set) includes all patients in the safety set except patients from a site who had major GCP issues. The Safety set includes all patients who received at least one dose of study drug whether or not being randomized||percentage of participants|||Number
817333|NCT01120691|Secondary|Time to Study Withdrawal or Premature Discontinuation for Any Reason Between QVA149 (110/50 µg q.d.), NVA237 (50 µg q.d.) and Open Label Tiotropium (18 µg q.d.) During the Treatment Period.|Time to Study Withdrawal or Premature Discontinuation for Any Reason was analyzed for each treatment group using a Kaplan-Meier estimation for the modified safety set. Patients who did not discontinue early were censored at the final visit of the treatment phase.|64 weeks|Modified safety set (mSAF set) includes all patients in the safety set except patients from a site who had major GCP issues. The Safety set includes all patients who received at least one dose of study drug whether or not being randomized. Analysis population included patients with study withdrawal or premature discontinuation for any reason.||days||95% Confidence Interval|Median
817334|NCT01120691|Secondary|Number of Days With Moderate or Severe Exacerbation That Required Treatment With Systemic Corticosteroids and Antibiotics|The number of exacerbation days is defined as the sum of the duration of days recorded as an exacerbation for all exacerbations recorded per patient.|64 weeks|Modified Full Analysis Set (mFAS) included all patients in the Full analysis set except patients from a site with GCP non-compliance. This is a sub-group analysis with mutually exclusive population in each category for analysis.||Days||Standard Deviation|Mean
817335|NCT01120691|Secondary|Rate of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Requiring the Use of Both Systemic Glucocorticosteroids and Antibiotics|Rate of moderate or severe exacerbations per year = total number of moderate or severe exacerbations / total number of treatment years|64 weeks|Modified Full Analysis Set (mFAS) included all patients in the Full analysis set except patients from a site, which had major issues with GCP compliance. The Full Analysis Set (FAS) includes all randomized patients who received at least one dose of study drug and data was available for analysis.||exacerbations per year|Participants||Number
817336|NCT01120691|Secondary|Time to First Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Between QVA149, NVA237 and Open Label Tiotropium During the Treatment Period|"A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as a worsening of two or more of the following major symptoms for at least 2 consecutive days: dyspnea, sputum volume or sputum purulence OR a worsening of any 1 major symptom together with an increase in any 1 of the following minor symptoms for at least 2 consecutive days: sore throat, colds (nasal discharge and/or nasal congestion), fever without other cause, cough or wheezing. A COPD exacerbation was considered of moderate severity if treatment with systemic glucocorticosteroids or antibiotics or both was required and severe if hospitalization was required. An emergency room (ER) visit of longer than 24 hours was considered a hospitalization.
Rate of moderate or severe exacerbations per year = total number of moderate or severe exacerbations / total number of treatment years"|64 weeks|Modified Full Analysis Set (mFAS) included all patients in the Full analysis set except patients from a site, which had major issues with GCP compliance. Only patients with a moderate or severe COPD exacerbation were included in this analysis.||days||95% Confidence Interval|Median
817348|NCT01120808|Primary|Count of Participants With Blisters||1 week|Participants with available data were analyzed||Participants|||Count of Participants
817349|NCT01120834|Primary|Overall Response Rate (ORR)|Overall Response Rate (ORR)|2 cycles|||Participants|||Count of Participants
817371|NCT01121146|Secondary|Patient Satisfaction|"Patient satisfaction was quantified by asking participants to respond yes or no to the question, Are you satisfied with the results of your hip operation?"|Minimum 9-year follow-up|Satisfaction rates were evaluated among 84 participants with unrevised hips who had Marathon and 70 participants with unrevised hips who had Enduron polyethylene. These participants had minimum 9-year follow-up and responded to the question about satisfaction.||percentage of participants|||Number
817337|NCT01120691|Secondary|Rate of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations in QVA149 and Open-label Tiotropium Treatment Arms During the Treatment Period.|"A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as a worsening of two or more of the following major symptoms for at least 2 consecutive days: dyspnea, sputum volume or sputum purulence OR a worsening of any 1 major symptom together with an increase in any 1 of the following minor symptoms for at least 2 consecutive days: sore throat, colds (nasal discharge and/or nasal congestion), fever without other cause, cough or wheezing. A COPD exacerbation was considered of moderate severity if treatment with systemic glucocorticosteroids or antibiotics or both was required and severe if hospitalization was required. An emergency room (ER) visit of longer than 24 hours was considered a hospitalization.
Rate of moderate or severe exacerbations per year = total number of moderate or severe exacerbations / total number of treatment years"|76 weeks|Modified Full Analysis Set (mFAS) included all patients in the Full analysis set except patients from a site, which had major issues with GCP compliance.||Exacerbations per year|Participants||Number
817338|NCT01120691|Primary|Rate of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations in QVA149 and NVA237 Treatment Arms During the Treatment Period.|"A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as a worsening of two or more of the following major symptoms for at least 2 consecutive days: dyspnea, sputum volume or sputum purulence OR a worsening of any 1 major symptom together with an increase in any 1 of the following minor symptoms for at least 2 consecutive days: sore throat, colds (nasal discharge and/or nasal congestion), fever without other cause, cough or wheezing. A COPD exacerbation was considered of moderate severity if treatment with systemic glucocorticosteroids or antibiotics or both was required and severe if hospitalization was required. An emergency room (ER) visit of longer than 24 hours was considered a hospitalization.
Rate of moderate or severe exacerbations per year = total number of moderate or severe exacerbations / total number of treatment years"|64 weeks|Modified Full Analysis Set (mFAS) included all patients in the Full analysis set except patients from a site , which had major issues with Good Clinical Practice (GCP) compliance.||Exacerbations per year|Participants||Number
817339|NCT01120704|Primary|Self-Reported 7-Day Point-Prevalence Abstinence|"Self-Reported 7-Day Point-Prevalence Abstinence is a dichotomous outcome with values of 0 and 1 where 0=smoking on one or more of the past 7 days at the assessment endpoint (52 weeks post-quit) and 1=no smoking on any of the past 7 days at the assessment endpoint (i.e., abstinent for the past 7 days); this outcome will be analyzed in a logistic regression analysis model.
Note: This abstinence primary outcome replaces latency to relapse (now designated as a secondary outcome) because reviewers of the now-accepted manuscript (at the journal Addiction) advised us to change the primary outcome to the current week 52 Self-Reported 7-Day Point-Prevalence Abstinence."|Assessed at 52 weeks after target quit day|||participants|||Number
817340|NCT01120704|Secondary|Latency to Relapse|Latency to Relapse during the first 12 months post-quit, with relapse defined as 7 consecutive days of smoking; this outcome will be analyzed in a Cox regression survival analysis model with non-relapsers coded as right-censored|Assessed during the first 12 months post-quit after target quit day|||participants|||Number
817341|NCT01120717|Secondary|Number of Patients With Notable Change From Baseline in Fridericia's QTc Values at Any Timepoint Over the Whole Treatment Period|Clinically notable change from baseline was and increase from baseline of 30 or greater milliseconds (ms).|52 weeks|Safety population - all patients who received at least one dose of study drug whether or not they were randomized. Only patients with the required data were included in this analysis.||participants|||Number
817342|NCT01120717|Secondary|Number of Patients With Newly Occurring or Worsening Clinically Notable Vital Signs Values at Any Timepoint Over the Whole Treatment Period|Clinically notable vital sign values were: pulse rate - low, <40 bpm or <=50 bpm and decrease from baseline >=15bpm; pulse rate high, >130 bpm or >=120bpm and increase from baseline >=15 bpm. Systolic blood pressure - low, <75 mmHg or <=90 mmHg and decrease from baseline >=20 mmHg; high, >200 mmHg or >=180 mmHg and increase from baseline >=20 mmHg. Diastolic blood pressure - low, <40 mmHg or <=50 mmHg and decrease from baseline >=15 mmHg; high, >115 mmHg or >=105 mmHg and increase from baseline >=15 mmHg.|52 weeks|Safety population - all patients who received at least one dose of study drug whether or not they were randomized. Only patients with the required data were included in this analysis.||participants|||Number
817343|NCT01120717|Secondary|Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Timepoint Over the Whole Treatment Period|Clinically notable biochemistry values were: sodium <125mmol/L or >160mmol/L; potassium <3.0mmol/L or >6.0mmol/L; BUN >9.99mmol/L; creatinine >176.8µmol/L; total protein (serum) <40g/L or >95g/L; albumin <25g/L; bilirubin (total) >34.2µmol/L; SGPT >3 x ULN; SGOT > 3 x ULN; gamma glutamyltransferase >3 x ULN; alkaline phosphatase (serum) >3 x ULN; glucose <2.78mmol/L or >9.99mmol/L|52 weeks|Safety population - all patients who received at least one dose of study drug whether or not they were randomized. Only patients with the required data were included in this analysis.||participants|||Number
817344|NCT01120717|Secondary|Number of Patients With Newly Occurring or Worsening Clinically Notable Hematology Values at Any Timepoint Over the Whole Treatment Period|Clinically notable hematology values were: hemoglobin - male <115g/L, female <95 g/L; hematocrit - male <0.37v/v, female <0.32v/v; white cell count - <2.8 10E9/L or >16.0 10E9/L; platelets - <75 10E9/L or >700 10E9/L|52 weeks|Safety population - all patients who received at least one dose of study drug whether or not they were randomized. Only patients with the required data were included in this analysis.||participants|||Number
817345|NCT01120717|Secondary|Pre-dose FEV1|Pre-dose FEV1 is defined as the average of the FEV1 15 minutes pre-dose and FEV1 45 minutes pre-dose. A mixed model was used with treatment as a fixed effect, average of 15 min and 45 min pre-dose FEV1 at visit 3 as the baseline measurement, and FEV1 prior to inhalation and FEV1 60 min post inhalation of two short acting bronchodialators as covariates. The model also included smoking status at baseline, history of ICS use and country as fixed effects with center nested within country as a random effect.|52 weeks|Full analysis set - all randomized patients who received at least one dose of study drug. Only patients with the required data were included in this analysis.||Liter||Standard Error|Least Squares Mean
817368|NCT01120990|Primary|Diastolic Blood Pressure Measured by Tested Device.|Mean Diastolic Blood pressure value of all BP measurements made by the tested device in all patients included in the analysis.|3 months|According to the European Society of Hypertension International Protocol 2010, recruitment is continued until 33 subjects that meet the entry criteria complete all the measurements.||mmHg||Standard Deviation|Mean
817350|NCT01120899|Secondary|Number of Fellow Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 24 Months Compared to Baseline|"Fluorescein angiography (FA) images from both eyes in each participant were obtained via a standard digital imaging system (OIS, Sacramento, CA) at baseline and at Month 6, Month 12, Month 18, and Month 24. Three retinal specialists independently graded the area of late fluorescein leakage (at approximately 10 minutes)in each eye using a region-of-interest tool in an image analysis software package (NIH ImageJ, Bethesda, MD).
The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria. The eye not chosen as the study eye is referred to as the fellow eye."|24 Months|||Eyes|Participants||Number
817351|NCT01120899|Secondary|Number of Fellow Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 18 Months Compared to Baseline|"Fluorescein angiography (FA) images from both eyes in each participant were obtained via a standard digital imaging system (OIS, Sacramento, CA) at baseline and at Month 6, Month 12, Month 18, and Month 24. Three retinal specialists independently graded the area of late fluorescein leakage (at approximately 10 minutes)in each eye using a region-of-interest tool in an image analysis software package (NIH ImageJ, Bethesda, MD).
The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria. The eye not chosen as the study eye is referred to as the fellow eye."|18 Months|||Eyes|Participants||Number
817352|NCT01120899|Secondary|Number of Fellow Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 12 Months Compared to Baseline|"Fluorescein angiography (FA) images from both eyes in each participant were obtained via a standard digital imaging system (OIS, Sacramento, CA) at baseline and at Month 6, Month 12, Month 18, and Month 24. Three retinal specialists independently graded the area of late fluorescein leakage (at approximately 10 minutes)in each eye using a region-of-interest tool in an image analysis software package (NIH ImageJ, Bethesda, MD).
The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria. The eye not chosen as the study eye is referred to as the fellow eye."|12 Months|||Eyes|Participants||Number
817353|NCT01120899|Secondary|Number of Fellow Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 6 Months Compared to Baseline|"Fluorescein angiography (FA) images from both eyes in each participant were obtained via a standard digital imaging system (OIS, Sacramento, CA) at baseline and at Month 6, Month 12, Month 18, and Month 24. Three retinal specialists independently graded the area of late fluorescein leakage (at approximately 10 minutes)in each eye using a region-of-interest tool in an image analysis software package (NIH ImageJ, Bethesda, MD).
The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria. The eye not chosen as the study eye is referred to as the fellow eye."|6 Months|||Eyes|Participants||Number
817354|NCT01120899|Secondary|Number of Study Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 24 Months Compared to Baseline|"Fluorescein angiography (FA) images from both eyes in each participant were obtained via a standard digital imaging system (OIS, Sacramento, CA) at baseline and at Month 6, Month 12, Month 18, and Month 24. Three retinal specialists independently graded the area of late fluorescein leakage (at approximately 10 minutes)in each eye using a region-of-interest tool in an image analysis software package (NIH ImageJ, Bethesda, MD).
The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria. The eye not chosen as the study eye is referred to as the fellow eye."|24 Months|||Eyes|Participants||Number
817355|NCT01120899|Secondary|Number of Study Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 18 Months Compared to Baseline|"Fluorescein angiography (FA) images from both eyes in each participant were obtained via a standard digital imaging system (OIS, Sacramento, CA) at baseline and at Month 6, Month 12, Month 18, and Month 24. Three retinal specialists independently graded the area of late fluorescein leakage (at approximately 10 minutes)in each eye using a region-of-interest tool in an image analysis software package (NIH ImageJ, Bethesda, MD).
The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria. The eye not chosen as the study eye is referred to as the fellow eye."|18 Months|||Eyes|Participants||Number
817356|NCT01120899|Primary|Number of Study Eyes Demonstrating an Increase or Decrease in Best-corrected Visual Acuity (BCVA) of 15 or More Early Treatment Diabetic Retinopathy Study (ETDRS) Letters at 6 Months Compared to Baseline|"Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.
The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria. The eye not chosen as the study eye is referred to as the fellow eye."|6 months|||Eyes|Participants||Number
817369|NCT01120990|Primary|Systolic Blood Pressure Measured With Mercury Sphygmomanometer.|Mean Systolic Blood pressure value of all BP measurements made by the two observers with mercury sphygmomanometers in all patients included in the analysis.|3 months|According to the European Society of Hypertension International Protocol 2010, recruitment is continued until 33 subjects that meet the entry criteria complete all the measurements.||mmHg||Standard Deviation|Mean
817357|NCT01120899|Secondary|Number of Study Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 12 Months Compared to Baseline|"Fluorescein angiography (FA) images from both eyes in each participant were obtained via a standard digital imaging system (OIS, Sacramento, CA) at baseline and at Month 6, Month 12, Month 18, and Month 24. Three retinal specialists independently graded the area of late fluorescein leakage (at approximately 10 minutes)in each eye using a region-of-interest tool in an image analysis software package (NIH ImageJ, Bethesda, MD).
The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria. The eye not chosen as the study eye is referred to as the fellow eye."|12 Months|||Eyes|Participants||Number
817358|NCT01120899|Secondary|Number of Study Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 6 Months Compared to Baseline|"Fluorescein angiography (FA) images from both eyes in each participant were obtained via a standard digital imaging system (OIS, Sacramento, CA) at baseline and at Month 6, Month 12, Month 18, and Month 24. Three retinal specialists independently graded the area of late fluorescein leakage (at approximately 10 minutes)in each eye using a region-of-interest tool in an image analysis software package (NIH ImageJ, Bethesda, MD).
The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria. The eye not chosen as the study eye is referred to as the fellow eye."|6 Months|||Eyes|Participants||Number
817359|NCT01120899|Secondary|Percentage Change in Retinal Thickness in the Study Eye at 24 Months Compared to Baseline|Retinal thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|Baseline and 24 Months|||percentage change in retinal thickness|Participants|Standard Deviation|Mean
817360|NCT01120899|Secondary|Percentage Change in Retinal Thickness in the Study Eye at 18 Months Compared to Baseline|Retinal thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|Baseline and 18 Months|||percentage change in retinal thickness|Participants|Standard Deviation|Mean
817361|NCT01120899|Secondary|Percentage Change in Retinal Thickness in the Study Eye at 12 Months Compared to Baseline|Retinal thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|Baseline and 12 Months|||percentage change in retinal thickness|Participants|Standard Deviation|Mean
817362|NCT01120899|Secondary|Percentage Change in Retinal Thickness in the Study Eye at 6 Months Compared to Baseline|"Retinal thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.
The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria. The eye not chosen as the study eye is referred to as the fellow eye."|Baseline and 6 Months|||percentage change|Participants|Standard Deviation|Mean
817363|NCT01120899|Secondary|Change in BCVA in the Study Eye at 24 Months Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 24 Months|||ETDRS letters|Participants|Standard Deviation|Mean
817364|NCT01120899|Secondary|Change in BCVA in the Study Eye at 18 Months Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 18 Months|||ETDRS letters|Participants|Standard Deviation|Mean
817365|NCT01120899|Secondary|Change in BCVA in the Study Eye at 12 Months Compared to Baseline|"Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.
The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria. The eye not chosen as the study eye is referred to as the fellow eye."|Baseline and 12 Months|||ETDRS Letters|Participants|Standard Deviation|Mean
817366|NCT01120899|Secondary|Change in BCVA in the Study Eye at 6 Months Compared to Baseline|"Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.
The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria. The eye not chosen as the study eye is referred to as the fellow eye."|Baseline and 6 Months|||ETDRS Letters|Participants|Standard Deviation|Mean
817367|NCT01120990|Primary|Diastolic Blood Pressure Measured With Mercury Sphygmomanometer.|Mean Diastolic Blood pressure value of all BP measurements made by the two observers with mercury sphygmomanometers in all patients included in the analysis.|3 months|According to the European Society of Hypertension International Protocol 2010, recruitment is continued until 33 subjects that meet the entry criteria complete all the measurements.||mmHg||Standard Deviation|Mean
817372|NCT01121146|Secondary|Harris Hip Score|The Harris Hip Score measures outcome after hip replacement and is based on a scale from 0 (worst) to 100 (best).|Minimum 9-year follow-up|Harris Hip Scores were evaluated for 74 unrevised hips with Marathon and 65 unrevised hips with Enduron polyethylene that had minimum 9-year follow-up and complete data to compute a score.||score on a 100 point scale||Standard Deviation|Mean
817373|NCT01121146|Secondary|Rate of Reoperation|The rate of reoperation was based on the number of reoperations in each group. Any additional surgery after a participant’s initial hip replacement was considered a reoperation.|10-year follow-up|All 116 hips randomized to Marathon polyethylene and all 114 hips randomized to Enduron polyethylene were included in the analysis population to determine the rate of reoperation.||THAs|||Number
817374|NCT01121146|Secondary|Polyethylene Wear|A single reviewer, who was blinded to the type of polyethylene liner, evaluated femoral head penetration among all unrevised hips with minimum 9-year radiographic follow-up using serial anteroposterior pelvic radiographs. Two-dimensional head penetration was determined for each follow-up radiograph relative to the immediate post-operative (nominal 6-week follow-up) reference view using Hip Suite Analysis version 8.0 with elliptical correction, a validated, computer-assisted technique. A linear wear rate was evaluated for each hip that had a minimum of three follow-up radiographs by using a least-squares linear regression to calculate the slope of the best-fit line for the wear vector magnitude versus time in situ data. The slope from this regression represented the steady-state linear wear rate. The steady-state linear wear rate data from all hips in a group was used to compute a mean polyethylene wear value.|Minimum 9-year radiographic follow-up|At least 3 head penetration measurements evaluated with Martell’s Hip Suite Analysis software were available for 76 unrevised hips with Marathon and 66 unrevised hips with Enduron polyethylene.||millimeters per year||Standard Deviation|Mean
817375|NCT01121146|Primary|Incidence of Clinically Significant Osteolysis|The incidence of clinically significant osteolysis was based on the number of unrevised THAs (total hip arthroplasties) with at least 1.5 square centimeters of pelvic and/or femoral osteolysis. Osteolysis was defined as an area of localized loss of trabecular bone or cortical erosion that was not apparent on the pre-operative or immediate postoperative radiograph. To obtain lesion sizes, the defects were outlined on the anteroposterior pelvic radiograph and the area of the lesion was measured using Martell's Hip Analysis Suite software. Lesions were considered clinically important if the total area of osteolysis around a hip replacement was at least 1.5 square centimeters.|Minimum 9-year radiographic follow-up|Minimum 9-year radiographs used to assess osteolysis were available for 79 unrevised hips with Marathon and 68 unrevised hips with Enduron polyethylene.||unrevised THAs|||Number
817376|NCT01121172|Secondary|Frequency of G212A Polymorphism of Apelin Receptor in Obese Children and Adolescents|Number of participants with Apelin Receptor Gene G212A polymorphism by genotype group|First day after enrollment|Data were collected only from the Obese participants. Data regarding the genetic polymorphism were not collected from participants forming the Lean Arm/Group.||participants|||Number
817377|NCT01121172|Primary|Serum Apelin Levels|Apelin levels were measured in serum of participants, in fasting state|First day after enrollment and after 8-hours of night fasting, at approximately 8:00 pm in the morning|||ng/ml||Full Range|Median
817378|NCT01121185|Post-Hoc|Time To Viral Rebound Post-Transplantation(Serum HCV RNA Increased ≥ 1 log10 From Viral Nadir)|The time of viral rebound was defined as the time of the first measurement of serum HCV RNA increased ≥ 1 log10 from the viral nadir (the lowest serum HCV RNA level post-transplantation). Serum HCV RNA was measured by RT-PCR.|Through Day 56|The eleven subjects who were randomized, initiated study infusions, and underwent liver transplantation were included in the analysis population.||days||Full Range|Mean
817379|NCT01121185|Secondary|Time to Onset of Recurrence of Detectable HCV RNA Post-Transplantation|Serum HCV RNA was measured by Quantitative RT-PCR|Through Day 56|The eleven subjects who were randomized, initiated study infusions, and underwent liver transplantation were included in the analysis population.||days|||Number
817380|NCT01121185|Secondary|Graft Function Assessed by Measurement of Biochemical and Synthetic Function at Multiple Time Points / Total Bilirubin|Biochemical function was assessed by measurement of alanine aminotransferase (ALT) and total bilirubin and synthetic function was assessment by measurement of the pro-thrombin time (reported as the international normalized ratio, INR) at multiple time-points during the 56-day study period. The table below displays the total bilirubin at each time-point.|Through Day 56|The eleven subjects who were randomized, initiated study infusions, and underwent liver transplantation were included in the analysis population.||mg/dL||Full Range|Mean
817381|NCT01121185|Secondary|Graft Function Assessed by Measurement of Biochemical and Synthetic Function at Multiple Time Points / Alanine Aminotransferase (ALT)|Biochemical function was assessed by measurement of alanine aminotransferase (ALT) and total bilirubin and synthetic function was assessment by measurement of the pro-thrombin time (reported as the international normalized ratio, INR) at multiple time-points during the 56-day study period. The table below displays the ALT at each time-point.|Through Day 56|The eleven subjects who were randomized, initiated study infusions, and underwent liver transplantation were included in the analysis population.||U/L||Full Range|Mean
817382|NCT01121185|Secondary|Graft Function Assessed by Measurement of Biochemical and Synthetic Function at Multiple Time Points / International Normalized Ratio (INR)|Biochemical function was assessed by measurement of alanine aminotransferase (ALT) and total bilirubin and synthetic function was assessment by measurement of the pro-thrombin time (reported as the international normalized ratio, INR) at multiple time-points during the 56-day study period. The table below displays the INR at each time-point. The INR is the ratio of a patient's prothrombin time to a control sample, raised to the power of the ISI value (International Sensitivity Index) for the batch of tissue factor being used for the assay.|Through Day 56|The eleven subjects who were randomized, initiated study infusions, and underwent liver transplantation were included in the analysis population.||unitless||Full Range|Mean
817395|NCT01121393|Secondary|Pharmacokinetics of Afatinib at Day 22|Outcome data are the trough plasma concentrations of afatinib at day 22 after multiple daily dosing of 40mg afatinib and after dose escalation to 50mg or dose reduction to 30mg afatinib (no patient dose reduced to 20mg during the PK assessment period).|Day 22 (course 2, visit 1)|All patients who had at least 1 afatinib dose and who had at least 1 valid afatinib plasma concentration available.||nanogram/millilitre (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
827177|NCT01202253|Secondary|Percentage of Participants Who Received 200 mg Loading Dose||Day 1|Full analysis set included all participants who met the defined eligibility criteria.||percentage of participants||95% Confidence Interval|Number
817383|NCT01121185|Secondary|Histologic Evidence of Hepatitis by Histologic Activity Index (HAI) Score at Baseline and Day 42|Liver biopsies obtained at baseline (day 0) and day 42 post-transplantation were assessed for histologic evidence of hepatitis by a pathologist blinded to treatment assignment using the Ishak modification of the Knodell histologic grading system to assign a histologic activity index (HAI) score. The HAI score consists of a sum of four components: 1) periportal or periseptal interface hepatitis; 2) confluent necrosis; 3) focal lytic necrosis, apoptosis and focal inflammation; 4) portal inflammation. The total HAI score can range from a minimum of 0 to a maximum of 18, with higher scores indicating more severe hepatic inflammation.|Baseline Day 0 and Day 42|The 11 subjects who were randomized, initiated study infusions, and underwent transplantation were included in the analysis population. On day 0, all subjects had pre-transplant biopsy specimens available for analysis. On day 42, 4 subjects in the MBL-HCV1 group and 5 subjects in the placebo group had biopsy specimens available for analysis.||Histologic activity index (HAI) score||Full Range|Median
817384|NCT01121185|Secondary|Change in Serum HCV RNA Between Baseline and Day 3, 14, 28 and 42 Post-Transplantation|Serum HCV RNA was measured by quantitative RT-PCR. The change in HCV RNA from baseline was obtained by calculating the difference between the baseline pre-transplantation HCV RNA level and the HCV RNA level measured at each study visit.|Baseline and Day 3, 14, 28 and 42 Post-Transplantation|The eleven subjects who were randomized, initiated study infusions, and underwent liver transplantation were included in the analysis population.||log10 IU/mL||Full Range|Median
817385|NCT01121185|Secondary|The Incidence of Adverse Events and Treatment-Emergent Adverse Events Determined Through Medical History, Physical Examination and Laboratory Evaluation|Adverse events were assessed by targeted medical history, physical examinations and laboratory testing. Subjects were asked at scheduled study visits through day 42 whether they experienced solicited adverse reactions (fever, chills, nausea, rash, joint pain or swelling, shortness of breath, headache, fatigue, and hives). In addition to these solicited adverse events, subjects were asked at all scheduled study visits through day 56 to report any other adverse events, regardless of whether the event was thought to be related to the study infusions. Adverse events were summarized by System Organ Class (SOC) using MedDRA (version 12.0)|Through Day 56|The eleven subjects who were randomized, initiated study infusions, and underwent liver transplantation were included in the analysis population.||events|||Number
817386|NCT01121185|Primary|Proportion of Subjects With Detectable Serum HCV RNA at Day 42 Post-Transplantation|Serum HCV RNA was measured by Quantitative RT-PCR|At Day 42 post-transplantation|The eleven subjects who were randomized, initiated study infusions, and underwent liver transplantation were included in the analysis population.||percentage of participants|||Number
817387|NCT01121211|Primary|Change From Baseline in Depression Symptom Severity|Hamilton Depression Rating Scale (HAM-D) (Higher score = greater depression symptom severity; Score Range 0 - ≥ 23)|Baseline, 24 weeks|All subjects who received at least one dose of study medication||HAM-D score on a scale||Standard Deviation|Mean
817388|NCT01121211|Primary|Change From Baseline in Weight|Weight in kilograms|Baseline, 24 Weeks|All subjects who received at least one dose of study medication||kilograms||Standard Deviation|Mean
817389|NCT01121263|Secondary|Major Adverse Cardiac and Cerebrovascular Event (MACCE)|"For the purposes of this study MACCE is defined as a non-weighted composite score comprised of the following components:
Death
Stroke
Myocardial infarction
Repeat revascularization"|Occurence of MACCE through the end of study up to two years|||participants|||Number
817390|NCT01121263|Primary|Major Adverse Cardiac and Cerebrovascular Event (MACCE)|"For the purposes of this study MACCE is defined as a non-weighted composite score comprised of the following components:
Death
Stroke
Myocardial Infarction
Repeat Revascularization"|Month 12|||participants|||Number
817391|NCT01121393|Secondary|Changes in Safety Laboratory Parameters|"Outcome data presented are the percentage of patients by worst CTCAE grade (only Grades 2 to 4 presented) on treatment for the following laboratory parameters: Potassium, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine and Creatine Kinase.
For Potassium; only CTCAE grades resulting from hypokalemia (low values) are presented.
Only data collected up to the analysis cut-off date (27 December 2013) were considered."|From first administration of study medication up to 28 days after the last administration of study medication up to 42.2 months|Treated set (TS) included all randomised patients who were documented to have taken at least 1 dose of study medication. Patients were allocated according to the treatment actually received. Patients with a baseline and at least one on-treatment assessment of the parameter of interest (Number of patients (N) are specified in the category title).||percentage of participants|||Number
817392|NCT01121393|Secondary|Safety of Afatinib as Indicated by Intensity and Incidence of Adverse Events|"Safety of Afatinib as indicated by intensity and incidence of adverse events graded according to the US National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Presented as the percentage of patients with an Adverse Events during the on-treatment period by highest CTCAE grade.
Only data collected up to the analysis cut-off date (27 December 2013) were considered."|From first administration of study medication up to 28 days after the last administration of study medication up to 42.2 months|The treated set (TS) included all randomised patients who were documented to have taken at least 1 dose of study medication (i.e. afatinib or gemcitabine / cisplatin). Patients were allocated according to the treatment actually received.||percentage of participants|||Number
817393|NCT01121393|Secondary|Pharmacokinetics of Afatinib at Day 43|Outcome data are the trough plasma concentrations of afatinib at day 43 after multiple daily dosing of 40mg afatinib and after dose escalation to 50mg or dose reduction to 30mg afatinib (no patient dose reduced to 20mg during the PK assessment period).|Day 43 (course 3, visit 1)|All patients who had at least 1 afatinib dose and who had at least 1 valid afatinib plasma concentration available.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
817394|NCT01121393|Secondary|Pharmacokinetics of Afatinib at Day 29|Outcome data are the trough plasma concentrations of afatinib at day 29 after multiple daily dosing of 40mg afatinib and after dose escalation to 50mg or dose reduction to 30mg afatinib (no patient dose reduced to 20mg during the PK assessment period).|Day 29 (course 2, visit 2)|All patients who had at least 1 afatinib dose and who had at least 1 valid afatinib plasma concentration available.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
818143|NCT01125202|Primary|Time Specific Interdialytic Weight Gain (Baseline)|Average interdialytic weight gains (kg/day) were calculated for the 1 week period prior to baseline measurement.|Baseline|Some participants have missing interdialytic weight gains due to missed hemodialysis treatments.||kg/day||Standard Deviation|Mean
817396|NCT01121393|Secondary|Health Related Quality of Life (HRQOL): Time of Deterioration in Pain|"HRQOL as measured by OLQ-C30 and its lung cancer module QLQ-LC13. Analysis for pain: composite of QLQ-C30, questions 9 and 19; individual items from QLQ-LC13, questions 10, 11 and 12.
Time to deterioration was defined as the time from randomisation to a score increase (i.e. worsened) of at least 10 points from baseline (0 to 100 point scale). Patients without deterioration (including those with disease progression) were censored at the date of the last available HRQOL assessment; patients without post-baseline assessments were censored at the date of randomisation. Patients were considered as having deteriorated at the time of death. Only data collected up until the analysis cut-off date (27 Dec 2013) were considered.
The median is Kaplan-Meier estimates."|Baseline and throughout the study (every 3 weeks) until progression or death (whichever occurs first) up to 42 months.|The randomised set.||months||95% Confidence Interval|Median
817397|NCT01121393|Secondary|Health Related Quality of Life (HRQOL): Time of Deterioration in Dyspnoea|"HRQOL as measured by OLQ-C30 and its lung cancer module (QLQ-LC13). Analysis for dyspnoea: composite of QLQ-LC13, questions 3 to 5; individual item from QLQ-C30, question 8.
Time to deterioration was defined as the time from randomisation to a score increase (i.e. worsened) of at least 10 points from baseline (0 to 100 point scale). Patients without deterioration (including those with disease progression) were censored at the date of the last available HRQOL assessment; patients without post-baseline assessments were censored at the date of randomisation. Patients were considered as having deteriorated at the time of death. Only data collected up until the analysis cut-off date (27 Dec 2013) were considered. The median is Kaplan-Meier estimates."|Baseline and throughout the study (every 3 weeks) until progression or death (whichever occurs first) up to 42 months.|The randomised set.||months||95% Confidence Interval|Median
817398|NCT01121393|Secondary|Health Related Quality of Life (HRQOL): Time of Deterioration in Coughing|"HRQOL as measured by standardised questionnaires (EuropeanOrganisation for Research and Treatment of Cancer (EORTC)) quality of life questionaires (OLQ-C30) and its lung cancer module (QLQ-LC13). Analysis for cough: QLQ-LC13, question 1.
Time to deterioration was defined as the time from randomisation to a score increase (i.e. worsened) of at least 10 points from baseline (0 to 100 point scale). Patients without deterioration (including those with disease progression) were censored at the date of the last available HRQOL assessment; patients without post-baseline assessments were censored at the date of randomisation. Patients were considered as having deteriorated at the time of death. Only data collected up until the analysis cut-off date (27 Dec 2013) were considered.
The median is Kaplan-Meier estimates."|Baseline and throughout the study (every 3 weeks) until progression or death (whichever occurs first) up to 42 months.|The randomised set.||months||95% Confidence Interval|Median
817399|NCT01121393|Secondary|Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)|"The last ECOG performance score category recorded during the study. Outcome data are the percentage of patients with an shift of ECOG performance status from baseline to the last ECOG performance status.
Only data collected up to the analysis cut-off date (27 December 2013) were considered.
ECOG PS measured on 6 point scale to assess participant's performance status. 0=Fully active, able to carry on all pre-disease activities without restriction;
Restricted in physically strenuous activity, but ambulatory and able to carry out light or sedentary work;
Ambulatory (>50 percent of waking hours), capable of all selfcare, unable to carry out any work activities;
Capable of only limited self care, confined to bed or chair more then 50 percent of waking hours;
Completely disabled, cannot carry on any selfcare, totally confined to bed or chair;
Dead"|Baseline and throughout the study (every 3 weeks) until progression or death (whichever occurs first) up to 42 months.|The randomised set. Data only presented for patients with a baseline and at least one post-baseline assessment of ECOG status.||percentage of participants|||Number
817400|NCT01121393|Secondary|Change From Baseline in Body Weight|The change from baseline to the lowest and the last body weight recorded or during the the study. Only data collected up until the analysis cut-off date (27 December 2013) were considered.|Baseline and throughout the study (every 3 weeks) until progression or death (whichever occurs first) up to 42 months.|The randomised set. Data only presented for a patient with a baseline and at least on post-baseline assessment of weight.||kilogram (kg)||Standard Deviation|Mean
817401|NCT01121393|Secondary|Tumour Shrinkage|"Tumour shrinkage is calculated as the minimum post-baseline sum of longest diameters of target lesions (longest for non-nodal lesions, short axis for nodal lesions) (SLD), as assessed by central independent review. The mean of these minimum values are presented after adjusting for baseline sum of longest diameters and EGFR mutation category. Only data collected up until the analysis cut-off date (27 Dec 2013) were considered. A negative value means the smallest post-baseline SLD was smaller than baseline (decreased since baseline); a positive value means tumor size increased since baseline.
The means are adjusted for baseline sum of lesions and EGFR mutation category."|Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 168|The randomised set. There were ony 220 patients in the Afatinib arm and 101 patients in the Gemcitabine / Cisplatin arm with baseline and post-baseline target lesion measurements.||millimetre (mm)||Standard Error|Mean
817402|NCT01121393|Secondary|Duration of Disease Control|"For patients with disease control, duration of disease control was defined as the time from randomisation to progression or death whichever occurs first. Only data collected up until the analysis cut-off date (27 Dec 2013) were considered.
A pre-defined set of censoring rules were used for patients who did not progress/die. The Median values are Kaplan-Meier estimates."|Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 168|The randomised set with disease control.||months||95% Confidence Interval|Median
817403|NCT01121393|Secondary|Duration of Objective Response|"OR is defined as a best of overall response of complete response (CR) or partial response (PR) assessed by central independent review according to RECIST version 1.1.
For patients with an objective response, duration of objective response was defined as the time from the first objective response to disease progression or death whichever occurs earlier. Only data collected up until the analysis cut-off date (27 Dec 2013) were considered.
A pre-defined set of censoring rules were used for patients who did not progress/die. The Median values are Kaplan-Meier estimates."|Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 168|The Randomised set with an objective response.||months||95% Confidence Interval|Median
834866|NCT01280604|Secondary|High-density Lipoprotein,(HDL)|HDL levels will be assessed in study participants 6-10 weeks after entry into study.|6-10 weeks|||milligram/deciliter||Standard Deviation|Mean
817404|NCT01121393|Secondary|Time to Objective Response (OR)|"OR is defined as a best of overall response of complete response (CR) or partial response (PR) assessed by central independent review according to RECIST version 1.1.
For patients with an objective response, time to objective response was defined as the time from randomisation to the first objective response.
Outcome data are the percentage of patients with OR by each scheduled tumour assessment.
Only data collected up until the analysis cut-off date (27 December 2013) were considered."|Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 168|The RS included all patients randomised to receive treatment, whether treated or not.||percentage of participants|||Number
817405|NCT01121393|Secondary|Overall Survival (OS)|"OS is defined as the time from randomisation to death. For patients who had not died by the cut-off date (27 Dec 2013), the date they were last known to be alive was derived from patient status records, the trial completion record, radiological imaging assessments, the study treatment termination record, and the randomisation date.
Median time results from unstratified Kaplan-Meier estimates."|From randomisation up to 27 Dec. 2013 cut off date for this analysis|The randomised set.||months||95% Confidence Interval|Median
817406|NCT01121393|Secondary|Disease Control (DC)|"DC is defined as a patient with objective response (OR) or stable disease (SD) assessed by central independent review according to RECIST version 1.1 and will be presented as the percentage of patients with DC.
Only data collected up until the analysis cut-off date (27 December 2013) were considered."|Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 168|The randomised set.||percentage of participants||95% Confidence Interval|Number
817407|NCT01121393|Secondary|Objective Response (OR)|"OR is defined as a best overall response of complete response (CR) or partial response (PR) assessed by central independent review according to RECIST version 1.1 and will be presented as the percentage of patients with OR.
CR is defined as the disappearance of all target lesions and non-target lesions and no new lesions.
PR is defined as at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD, non-Progressive Disease or non evaluation of all non-target lesions and no new lesions.
Only data collected up until the analysis cut-off date (27 December 2013) were considered.
(Exact 95% Confidence interval by Clopper and Pearson.)"|Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 168|The randomised set.||percentage of participants||95% Confidence Interval|Number
817408|NCT01121393|Primary|Progression-free Survival|"The primary endpoint was progression-free survival (PFS) as assessed by central independent review according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. Progression-free survival was defined as the time from randomisation to disease progression or death whichever occurs earlier. A pre-defined set of censoring rules were used for patients who did not have a PFS.
Only data collected up until the analysis cut-off date (27 December 2013) were considered. Median time results from unstratified Kaplan-Meier estimates."|Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 168|The randomised set (RS) included all patients randomised to receive treatment, whether treated or not.||months||95% Confidence Interval|Median
817409|NCT01121406|Secondary|Biomarkers and Pharmacogenetics Analysis (Optional)|This endpoint has not been statistically analysed in the study report|6 months||||||
817410|NCT01121406|Secondary|Vss;Apparent Volume of Distribution at Steady State Following Intravenous Administration for BI 6727 BS|Vss;apparent volume of distribution at steady state following intravenous administration for BI 6727 BS|-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration|All evaluable patients were to be included in the pharmacokinetic analysis. A patient was considered not evaluable if they had an important protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||Litres||Geometric Coefficient of Variation|Geometric Mean
817411|NCT01121406|Secondary|CL; Total Clearance of BI 6727 BS in Plasma After Intravenous Administration|CL; total clearance of BI 6727 BS in plasma after intravenous administration|-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration|All evaluable patients were to be included in the pharmacokinetic analysis. A patient was considered not evaluable if they had an important protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||mL/min||Geometric Coefficient of Variation|Geometric Mean
817412|NCT01121406|Secondary|MRT; Mean Residence Time of BI 6727 BS in the Body|MRT; Mean residence time of BI 6727 BS in the body|-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration|All evaluable patients were to be included in the pharmacokinetic analysis. A patient was considered not evaluable if they had an important protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||hours||Geometric Coefficient of Variation|Geometric Mean
817413|NCT01121406|Secondary|t1/2; Terminal Half-life of CD 10899 BS in Plasma|t1/2; Terminal half-life of CD 10899 BS in plasma|-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration|All evaluable patients were to be included in the pharmacokinetic analysis. A patient was considered not evaluable if they had an important protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||hours||Geometric Coefficient of Variation|Geometric Mean
817414|NCT01121406|Secondary|t1/2; Terminal Half-life of BI 6727 BS in Plasma|t1/2; Terminal half-life of BI 6727 BS in plasma|-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration|All evaluable patients were to be included in the pharmacokinetic analysis. A patient was considered not evaluable if they had an important protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||hours||Geometric Coefficient of Variation|Geometric Mean
817415|NCT01121406|Secondary|Tmax; Time From Dosing to Maximum Measured Concentration of CD 10899 BS in Plasma|tmax; time from dosing to maximum measured concentration of CD 10899 BS (metabolite of Volasertib BI 6727) in plasma|-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration|All evaluable patients were to be included in the pharmacokinetic analysis. A patient was considered not evaluable if they had an important protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||hours||Full Range|Median
818238|NCT01118117|Secondary|Major Adverse Events (MAEs) Through 12 Months Post-procedure|The incidence of MAEs occurring within 12 months of the procedure. MAE is defined as target lesion revascularization (TLR), amputation of the treated limb, or death.|12 Months post-procedure|||percentage of subjects with event|||Number
817416|NCT01121406|Secondary|Tmax; Time From Dosing to Maximum Measured Concentration of BI 6727 BS in Plasma|tmax; time from dosing to maximum measured concentration of BI 6727 BS in plasma|-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration|All evaluable patients were to be included in the pharmacokinetic analysis. A patient was considered not evaluable if they had an important protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||hours||Full Range|Median
817417|NCT01121406|Secondary|Cmax; Maximum Measured Concentration of CD 10899 BS in Plasma|Cmax; maximum measured concentration of CD 10899 BS (metabolite of Volasertib BI 6727) in plasma|-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration|All evaluable patients were to be included in the pharmacokinetic analysis. A patient was considered not evaluable if they had an important protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
817418|NCT01121406|Secondary|Cmax; Maximum Measured Concentration of BI 6727 BS in Plasma|Cmax; maximum measured concentration of BI 6727 BS in plasma|-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration|All evaluable patients were to be included in the pharmacokinetic analysis. A patient was considered not evaluable if they had an important protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
817419|NCT01121406|Secondary|AUC (0-inf); Area Under the Concentration-time Curve in Plasma Over the Time Interval From 0 Extrapolated to Infinity for CD 10899 BS|AUC (0-inf); area under the concentration-time curve in plasma over the time interval from 0 extrapolated to infinity for CD 10899 BS (metabolite of Volasertib BI 6727)|-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration|All evaluable patients were to be included in the pharmacokinetic analysis. A patient was considered not evaluable if they had an important protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
817420|NCT01121406|Secondary|AUC (0-inf); Area Under the Concentration-time Curve in Plasma Over the Time Interval From 0 Extrapolated to Infinity for BI 6727 BS|AUC (0-inf); area under the concentration-time curve in plasma over the time interval from 0 extrapolated to infinity for BI 6727 BS|-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration|All evaluable patients were to be included in the pharmacokinetic analysis. A patient was considered not evaluable if they had an important protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
817421|NCT01121406|Secondary|AUC (0-24); Area Under the Concentration-time Curve in Plasma Over the Time Interval From 0 to 24 Hours for CD 10899 BS|AUC (0-24); area under the concentration-time curve in plasma over the time interval from 0 to 24 hours for CD 10899 BS (metabolite of Volasertib BI 6727)|-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration|All evaluable patients were to be included in the pharmacokinetic analysis. A patient was considered not evaluable if they had an important protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
817422|NCT01121406|Secondary|AUC (0-24); Area Under the Concentration-time Curve in Plasma Over the Time Interval From 0 to 24 Hours for BI 6727 BS|AUC (0-24); area under the concentration-time curve in plasma over the time interval from 0 to 24 hours for BI 6727 BS|-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration|All evaluable patients were to be included in the pharmacokinetic analysis. A patient was considered not evaluable if they had an important protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
817423|NCT01121406|Secondary|Clinically Relevant Changes in Laboratory and ECG Data|Clinically relevant changes in laboratory and ECG data|From first treatment administration to 21 days after the last drug administration (Up to 1403 days)|TS||percentage of participants|||Number
817424|NCT01121406|Secondary|Incidence and Intensity of Adverse Events According to the United States National Cancer Institute (US NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0|Incidence and intensity of adverse events according to the United States National Cancer Institute (US NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0|From first treatment administration to 21 days after the last drug administration (Up to 1403 days)|TS||participants|||Number
817425|NCT01121406|Secondary|Time to Deterioration in the Three Most Troublesome Disease Specific Symptoms/ Quality of Life (QOL)|"Three most troublesome disease specific symptoms, defined by the patient at baseline.
Patients that have defined more than 3 most troublesome symptoms have not been taken into account in the analysis.
Quality of life (QOL) and symptom control assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, QLQ-OV28, and individual symptom questionnaires.
The time to deterioration was defined as the time from randomisation to a score increased (i.e. worsened) by at least 10 points from baseline (0-100 point scale). If score is missing, and patient died within 28 days after scheduled time for completion, the patient was considered deteriorated. In this case, time to deterioration is time to death."|Every 6 weeks (Up to 213 weeks)|TS||weeks||Inter-Quartile Range|Median
817426|NCT01121406|Secondary|Time to Deterioration in Abdominal Bloating/ Quality of Life (QOL)|"Time to deterioration in abdominal bloating/ Quality of life (QOL) and symptom control assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, QLQ-OV28, and individual symptom questionnaires.
The time to deterioration was defined as the time from randomisation to a score increased (i.e. worsened) by at least 10 points from baseline (0-100 point scale). If score is missing, and patient died within 28 days after scheduled time for completion, the patient was considered deteriorated. In this case, time to deterioration is time to death."|Every 6 weeks (Up to 213 weeks )|TS||weeks||Inter-Quartile Range|Median
817427|NCT01121406|Secondary|Time to Deterioration in Pain/ Quality of Life (QOL)|"Time to deterioration in pain/ Quality of life (QOL) and symptom control assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, QLQ-OV28, and individual symptom questionnaires.
The time to deterioration was defined as the time from randomisation to a score increased (i.e. worsened) by at least 10 points from baseline (0-100 point scale). If score is missing, and patient died within 28 days after scheduled time for completion, the patient was considered deteriorated. In this case, time to deterioration is time to death."|Every 6 weeks (Up to 213 weeks )|TS||weeks||Inter-Quartile Range|Median
834867|NCT01280604|Secondary|Low-density Lipoprotein (LDL)|LDL levels will be assessed in study participants 6-10 weeks after entry into study.|6-10 weeks|||milligram/deciliter||Standard Deviation|Mean
817428|NCT01121406|Secondary|Time to Deterioration in Fatigue/Quality of Life (QOL)|"Time to deterioration in fatigue/Quality of life (QOL) and symptom control assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, QLQ-OV28, and individual symptom questionnaires.
The time to deterioration was defined as the time from randomisation to a score increased (i.e. worsened) by at least 10 points from baseline (0-100 point scale). If score is missing, and patient died within 28 days after scheduled time for completion, the patient was considered deteriorated. In this case, time to deterioration is time to death."|Every 6 weeks (Up to 213 weeks )|TS||weeks||Inter-Quartile Range|Median
817429|NCT01121406|Secondary|Time to Deterioration in Global Health Status/Quality of Life (QOL)|"Time to deterioration in global health status/Quality of life (QOL) and symptom control assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, QLQ-OV28, and individual symptom questionnaires.
The time to deterioration was defined as the time from randomisation to a score increased (i.e. worsened) by at least 10 points from baseline (0-100 point scale). If score is missing, and patient died within 28 days after scheduled time for completion, the patient was considered deteriorated. In this case, time to deterioration is time to death."|Every 6 weeks (Up to 213 weeks )|TS||weeks||Inter-Quartile Range|Median
817430|NCT01121406|Secondary|Biological Progression-free Survival Based on Serum Cancer Antigen 125 (CA-125) According to the Gynaecologic Cancer Intergroup (GCIG) Criteria|"Biological PFS including assessment of CA-125 levels was defined as the time from randomisation until the first occurrence of progressive disease according to CA-125, progressive disease according to radiological evidence, or death.
Also according to the below criterias,
In patients with radiological measurable disease, disease progression during study treatment could not be declared on the basis of CA-125 alone.
Patients with elevated CA-125 pre-treatment and normalization of CA-125 had to show evidence of CA-125 ≥ to two times the upper normal limit on two occasions at least one week apart or
Patients with elevated CA-125 pre-treatment, which never normalized, had to show evidence of CA-125 ≥ to two times the nadir value on two occasions at least one week apart or
Patients with CA-125 in the normal range pre-treatment had to show evidence of CA-125 ≥ to two times the upper normal limit on two occasions at least one week apart."|At screening and every 6 weeks thereafter (Up to 213 weeks )|TS||weeks||Inter-Quartile Range|Median
817431|NCT01121406|Secondary|Biological Tumour Response Based on Serum Cancer Antigen 125 (CA-125) According to the Gynaecologic Cancer Intergroup (GCIG) Criteria|"Patients were to have a pre-treatment CA-125 of at least twice the upper limit of normal to be considered for CA-125 response. Patients were not evaluable by CA-125 if they had received mouse antibodies or if they had undergone medical and/or surgical interference with their peritoneum or pleura during the previous 28 days. In eligible patients, a CA-125 response was defined as the moment the CA- 25 was reduced by 50%, with this being confirmed with a consecutive CA-125 assessment not earlier than 28 days after the previous one.
Biological response rate based on serum CA-125 levels was assessed according to the guidelines by the Gynaecologic Cancer Intergroup. Monitoring of blood levels of the tumour marker CA-125 was performed at screening and every 6 weeks thereafter."|At screening and every 6 weeks thereafter (Up to 213 weeks)|TS||participants|||Number
817432|NCT01121406|Secondary|Best Overall Response|"Best overall response (BOR) is defined as the best response recorded at any time from the date of randomisation until the end of treatment.
Missing categories signify that no tumour imaging has been performed post baseline, and therefore the response status could not be assessed."|time from the date of randomisation until study completion/discontinuation; Up to 213 weeks|TS||participants|||Number
817433|NCT01121406|Secondary|Overall Survival (OS)|OS is defined as time from randomisation to death irrespective of the cause of the death.|From randomization until death or study discontinuation; Up to 213 weeks|TS||weeks||Inter-Quartile Range|Median
817434|NCT01121406|Secondary|Progression Free Survival (PFS)|"Progression-free survival of a patient was based on the investigator’s assessment; it was defined as the number of days from the date of randomisation until the date of either disease progression or death from any cause, whichever occurred first.
Definition of disease progression according to RECIST version 1.1; Patients with measurable tumour lesions at baseline, Target-lesions: at least a 20% increase in the sum of diameters of target lesions, the sum of diameters must also demonstrate an absolute increase of at least 5 mm,taking as reference the smallest sum on study, or appearance of 1 or more new lesions.
Non-target lesions: unequivocal progression of existing non-target lesions or appearance of 1 or more new lesions Patients with non-measurable tumour lesions at baseline, Non-target lesions: requires unequivocal progression of existing non-target lesions or appearance of 1 or more new lesions"|From randomization until disease progression, death or study discontinuation; Up to 213 weeks|TS||weeks||Inter-Quartile Range|Median
817435|NCT01121406|Primary|Disease Control Rate (DCR) at Week 24 According to Response Evaluation Criteria In Solid Tumours (RECIST) Version 1.1|DCR was defined as the proportion of patients who had an overall response of complete response (CR), partial response (PR), or stable disease (SD).|Week 24|TS||percentage of participants||95% Confidence Interval|Number
817436|NCT01110421|Secondary|Number of Participants With Sustained Favorable Per-pathogen Microbiological Outcome Rate at Late Follow-Up (LFU) Visit|A total of 3 pathogens were isolated at baseline from lower respiratory tract (LRT) culture in 2 participants in the doripenem treatment group and were susceptible to the study drug received: 2 pathogens (Staphylococcus aureus Klebsiella pneumoniae) were isolated at baseline from 1 participant and a 3rd pathogen (Streptococcus pneumoniae) was isolated at baseline from the other participant (see listed in the table below; the number in parenthesis next to each pathogen represent the number of participants with the pathogen isolated at baseline in the doripenem treatment group). The favorable per-participant microbiological response was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment). NOTE: No participants in the cefepime treatment group met criteria for inclusion in the Microbiological intent-to-treat analysis.|LFU (28 to 42 days after the last dose of study medication therapy)|Microbiological intent-to-treat - Participants of CITT with at least one baseline pneumonia pathogen from pleural fluid, LRT, or blood culture susceptible to doripenem and cefepime. 3 and 2 participants from doripenem and cefepime, respectively had no susceptible pneumonia pathogens at baseline and were excluded from this set.||Participants|||Number
818239|NCT01118117|Secondary|Clinical Success|Clinical success defined as: relief or improvement from baseline symptoms as measured by the Rutherford score for chronic limb ischemia at 30 days as compared to baseline|30 days post-procedure|||percentage of subjects with success|||Number
817437|NCT01110421|Secondary|Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at Test Of Cure (TOC) Visit|A total of 3 pathogens were isolated at baseline from lower respiratory tract (LRT) culture in 2 participants in the doripenem treatment group and were susceptible to the study drug received: 2 pathogens (Staphylococcus aureus Klebsiella pneumoniae) were isolated at baseline from 1 participant and a 3rd pathogen (Streptococcus pneumoniae) was isolated at baseline from the other participant (see listed in the table below; the number in parenthesis next to each pathogen represent the number of participants with the pathogen isolated at baseline in the doripenem treatment group). The favorable per-participant microbiological response was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment). NOTE: No participants in the cefepime treatment group met criteria for inclusion in the Microbiological intent-to-treat analysis.|TOC (7 to 14 days after the last dose of study medication therapy)|Microbiological intent-to-treat - Participants of CITT with at least one baseline pneumonia pathogen from pleural fluid, LRT, or blood culture susceptible to doripenem and cefepime. 3 and 2 participants from doripenem and cefepime, respectively had no susceptible pneumonia pathogens at baseline and were excluded from this set.||Participants|||Number
817438|NCT01110421|Secondary|Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at End of IV (EIV) Visit|A total of 3 pathogens were isolated at baseline from lower respiratory tract (LRT) culture in 2 participants in the doripenem treatment group and were susceptible to the study drug received: 2 pathogens (Staphylococcus aureus Klebsiella pneumoniae) were isolated at baseline from 1 participant and a 3rd pathogen (Streptococcus pneumoniae) was isolated at baseline from the other participant (see listed in the table below; the number in parenthesis next to each pathogen represent the number of participants with the pathogen isolated at baseline in the doripenem treatment group). The favorable per-participant microbiological response was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment). NOTE: No participants in the cefepime treatment group met criteria for inclusion in the Microbiological intent-to-treat analysis.|EIV (within 24 hours after completion of the last dose of IV study medication therapy)|Microbiological intent-to-treat - Participants of CITT with at least one baseline pneumonia pathogen from pleural fluid, LRT, or blood culture susceptible to doripenem and cefepime. 3 and 2 participants from doripenem and cefepime, respectively had no susceptible pneumonia pathogens at baseline and were excluded from this set.||Participants|||Number
817439|NCT01110421|Secondary|The Number of Participants With Favorable Per-participant Microbiological Response Rate|Favorable per-participant microbiological response rate was evaluated at the at End of IV (EIV) visit, Test Of Cure (TOC) visit, and Late Follow-Up (LFU) visit. The favorable per-participant microbiological response was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment).|EIV (within 24 hours after completion of the last dose of IV study medication therapy), TOC (7 to 14 days after the last dose of study medication therapy), and LFU (28 to 42 days after the last dose of study medication therapy)|Microbiological intent-to-treat - Participants of CITT with at least one baseline pneumonia pathogen from pleural fluid, LRT, or blood culture susceptible to doripenem and cefepime. 3 and 2 participants from doripenem and cefepime, respectively had no susceptible pneumonia pathogens at baseline and were excluded from this set.||Participants|||Number
817440|NCT01110421|Secondary|The Number of Participants With Clinical Cure Rate at Late Follow-Up (LFU) Visit|The participants were classified as clinical cure if all pretreatment signs and symptoms showed no evidence of resurgence after administration of the last dose of study medication and no nonstudy systemic antibacterial therapy was given for the treatment of pneumonia.|LFU (28 to 42 days after the last dose of study medication therapy)|Clinical Intent-to-Treat (CITT): All randomized participants who met the minimal disease definition of pneumonia regardless if a baseline pathogen was isolated from the baseline lower respiratory tract (LRT) culture, pleural fluid or blood culture.||Participants|||Number
817441|NCT01110421|Secondary|The Number of Participants With Clinical Improvement Rate at End of IV (EIV) Visit|Participants were considered as clinical improved if they had no fever, clinical improvement in signs and symptoms of pneumonia from baseline, decrease in WBC, improvement or lack of progression of radiographic findings in comparison with the screening chest X-ray, and not received any nonstudy systemic antibacterial therapy for the treatment of pneumonia after IV study drug therapy had begun.|EIV (within 24 hours after completion of the last dose of IV study medication therapy)|Clinical intent-to-treat: All randomized participants who met the minimal disease definition of pneumonia regardless if a baseline pathogen was isolated from the baseline lower respiratory tract culture, pleural fluid or blood culture.||Participants|||Number
817442|NCT01110421|Primary|The Number of Participants With Clinical Cure Rate at Test Of Cure (TOC) Visit|The participants were classified as cure if they had resolution or clinical improvement of signs and symptoms of pneumonia, favorable response at End of treatment for IV study (EIV) visit; had no fever; improvement or no progression of radiographic findings of pneumonia on chest X ray; improvement in oxygenation or discontinued mechanical ventilation in intubated participants; and not received nonstudy systemic antibacterial therapy for pneumonia.|TOC (7 to 14 days after the last dose of study medication therapy)|Clinical Intent-To-Treat (CITT): All randomized participants who met the minimal disease definition of pneumonia regardless if a baseline pathogen was isolated from the baseline lower respiratory tract culture, pleural fluid or blood culture.||Participants|||Number
817443|NCT01110499|Primary|Part 2: Change From Baseline in Average Eye Intraocular Pressure (IOP)|IOP is a measurement of the fluid pressure inside the eye. Average IOP is the average of the 2 eyes for each patient at each time point. A negative number change from Baseline indicates a reduction in IOP (improvement). Data are recorded at Hours 0, 2, 4, 6, 8, and 12.|Baseline, Day 29|Modified Intent to Treat: all randomized and treated patients who provided IOP data for baseline and at least one postbaseline hour 0 assessment||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
817444|NCT01110499|Primary|Part 1: Change From Baseline in Intraocular Pressure (IOP)|IOP is a measurement of the fluid pressure inside the eye. Data are recorded at Hours 0, 2, 4, 6, 8, and 12. A negative number change from Baseline indicated a reduction in IOP (improvement). Data for bimatoprost-treated eyes are combined across groups.|Baseline, Day 7|Safety Population: all treated patients||Millimeters of Mercury (mmHg)|Participants|Standard Deviation|Mean
817445|NCT01110915|Secondary|System-related Complications|Subjects with a complication related to the implanted system, which consisted of the pacemaker, leads to the right chambers of the heart (atrium and ventricle), pacemaker software, and programmer. All adverse events in the time frame were recorded at the subject's center and assessed the AEAC. The AEAC determined whether each adverse event was a complication (requiring invasive intervention), and whether the event was related to the system.|Implant to four months post implant|||participants|||Number
817446|NCT01110915|Secondary|Occurrence of Sustained Ventricular Arrhythmias and Asystole During MRI Scans.|The endpoint was the occurrence of sustained ventricular arrhythmias and asystole during MRI scans and attributable to the MR scan. Sustained ventricular arrhythmias or asystole episodes that occurred during the MRI scan was considered attributable to the MR scan if so adjudicated by the AEAC.|During MRI scans|All subjects successfully implanted with the Advisa MRI system who underwent MRI scans were included in the analysis. All MRI scans, whether done at the 9-12 week visit in the MRI group, or done at other times in either group were included in this analysis.||participants|||Number
817447|NCT01110915|Secondary|Ventricular Sensed Amplitude Success|Subjects' ventricular sensed amplitude was measured at the 9-12 week visit (pre-MRI/waiting period) and the 4-month visit (i.e. one month post-MRI/waiting period). A success was defined as a 50% or less decrease in ventricular sensed amplitude between the two visits.|Pre-MRI /waiting period to 1-month post-MRI/waiting period|Only subjects with measured sensed amplitude values at both pre-MRI/waiting period and the 4-month visit were used in the analysis.||participants|||Number
817448|NCT01110915|Secondary|Atrial Sensed Amplitude Success|Subjects' atrial sensed amplitude was measured at the 9-12 week visit (pre-MRI/waiting period) and the 4-month visit (i.e. one month post-MRI/waiting period). A success was defined as a 50% or less decrease in atrial sensed amplitude between the two visits.|Pre-MRI /waiting period to 1-month post-MRI/waiting period|Only subjects with measured sensed amplitude values at both pre-MRI/waiting period and the 4-month visit were used in the analysis.||participants|||Number
817449|NCT01110915|Primary|Ventricular Pacing Capture Threshold Success|Subjects' ventricular pacing capture threshold was measured at the 9-12 week visit (pre-MRI/waiting period) and the 4-month visit (i.e. one month post-MRI/waiting period). A success was when a subject experienced an increase less than or equal to 0.5V (volts) between the two visits.|Pre-MRI /waiting period to 1-month post-MRI/waiting period|To be included in the analysis, subjects in the MRI group must undergo an MRI scan and those in the Control group must complete the 9-12 week visit, and all the subjects must have valid pacing capture threshold measurements at pre-MRI/waiting period and the 4-month visit.||participants|||Number
817450|NCT01110915|Primary|Atrial Pacing Capture Threshold Success|Subjects' atrial pacing capture threshold was measured at the 9-12 week visit (pre-MRI/waiting period) and the 4-month visit (i.e. one month post-MRI/waiting period). A success was when a subject experienced an increase less than or equal to 0.5V (volts) between the two visits.|Pre-MRI/waiting period to one month post-MRI/waiting period|To be included in the analysis, subjects in the MRI group must undergo an MRI scan and those in the Control group must complete the 9-12 week visit, and all the subjects must have valid pacing capture threshold measurements at pre-MRI/waiting period and the 4-month visit.||participants|||Number
817451|NCT01110915|Primary|Magnetic Resonance Imaging (MRI)-Related Complications|For each subject in this objective, the endpoint was the occurrence of an MRI-related complication within 30 days post-MRI. An independent Adverse Event Advisory Committee (AEAC) determined whether each adverse event was a complication and whether it was MRI-related.|MRI scan to one-month post-MRI scan|Subjects who had an MRI scan and completed their 4-month visit (or a later follow-up), or had an MRI-related complication within one month post-MRI were included in the analysis.||participants|||Number
817452|NCT01110967|Primary|Safety by Evaluating the Number of Serious Adverse Device Effects (SADEs), Adverse Device Effects (ADEs) and Serious Adverse Events (SAEs)||Patients were followed up according to the local practice, up to 1 year|||events|||Number
817453|NCT01110967|Secondary|Changes in Device Placement||Up to 12 months follow up visit|||participant|||Number
817454|NCT01110967|Secondary|Device Subsidence Measured as Interbody Height Ratio (IBHR)|Interbody Height Ratio (IBHR) is calculated as the total vertical height of the two vertebral bodies directly superior and inferior to the implant divided by the anteroposterior diameter of the superior vertebral body.|Up to 12 months follow up visit|||ratio||Standard Deviation|Mean
817455|NCT01110967|Secondary|Intervertebral Disc Space (IVD) at Implanted Level|The Intervertebral Disc Space (IVD) was measured as average disc height, calculated as [(A+B)/2]/H, where A is the posterior intervertebral disc height, B is the anterior intervertebral disc height and H is the anterior height of upper vertebral body.|Up to 12 months follow up visit|||mm||Standard Deviation|Mean
817456|NCT01110967|Secondary|Range of Motion (ROM) at Implanted Level|The range of motion (ROM) was calculated as the angle of the segment on the flexion radiograph minus the angle of the segment on the extension radiograph, expressed in degrees (absolute value).|Up to 12 months follow up visit|||degrees||Standard Deviation|Mean
817457|NCT01110967|Primary|Physical Functioning Using the Oswestry Disability Index (ODI)|The Oswestry Disability Index (ODI) derives from the Oswestry Low Back Pain Questionnaire, it is used to measure disability for low back pain. The index is scored from 0 to 50; 0 meaning 'no disability' and 50 meaning 'maximum disability'.|Up to 12 months follow up visit|||units on a scale||Standard Deviation|Mean
817458|NCT01110967|Primary|Health-related Quality of Life Using the Visual Analogue Scale for Leg Pain|The Visual Analogue Scale (VAS) is a tool widely used to measure pain. It is a 10 cm scale, 0cm means 'no pain' and 10cm means 'worst possible pain'. The patients mark the location corresponding to the amount of back pain they experienced on the 10cm line.|Up to 12 months follow up visit|||units on a scale||Standard Deviation|Mean
817459|NCT01110967|Primary|Health-related Quality of Life Using the Visual Analogue Scale for Back Pain|The Visual Analogue Scale (VAS) is a tool widely used to measure pain. It is a 10 cm scale, 0cm means 'no pain' and 10cm means 'worst possible pain'. The patients mark the location corresponding to the amount of back pain they experienced on the 10cm line.|Up to 12 months follow up visit|||units on a scale||Standard Deviation|Mean
817471|NCT01111149|Secondary|Hit Reaction Time - CPT|The hit reaction time is the average speed of correct responses for the entire test given in milliseconds. The higher the score, the slower the speed. The standard error is a measure of response speed consistency. The higher the overall standard error, the greater inconsistency in the response speed. The values below were measured at week 12.|Week 12|||milliseconds||Standard Deviation|Mean
817460|NCT01111110|Primary|Y=100([FEV1 at 4 Puffs-FEV1 at 4AM)/FEV1@4AM] Difference Period 2 Minus Period 1.|(Percent improvement in FEV1 Post Dose for Period 2 over 4AM Baseline value)less (Percent improvement in FEV1 Post Dose for Period 1 over 4AM Baseline value) when 4 Puffs go into chamber|fifteen minutes after 4 puffs of albuterol|Study intended to get more subjects, but PI's review committee had to deal with candidate deadlines and a high rate of screen failures and allowed her to test seven subjects. Primary concern was the research experience, not the study questions. There was no bias in failing to meet accrual objectives thanks to the blinding.||Diff in % change from 4AM||Standard Deviation|Mean
817461|NCT01111110|Primary|Y=100([FEV1 at 2 Puffs-FEV1 at 4AM)/FEV1@4AM] Difference Period 2 Minus Period 1.|(Percent improvement in FEV1 Post Dose for Period 2 over 4AM Baseline value) less (Percent improvement in FEV1 Post Dose for Period 1 over 4AM Baseline value) when 2 Puffs go into chamber|15 minutes after 2 puffs of albuterol|Study intended to get more subjects, but PI's review committee had to deal with candidate deadlines and a high rate of screen failures and allowed her to test seven subjects. Primary concern was the research experience, not the study questions. There was no bias in failing to meet accrual objectives thanks to the blinding.||Diff in % change from 4AM||Standard Deviation|Mean
817462|NCT01111110|Primary|Y=100([FEV1 at 1 Puffs-FEV1 at 4AM)/FEV1@4AM] Difference Period 2 Minus Period 1.|(Percent improvement in FEV1 Post Dose for Period 2 over 4AM Baseline value) less (Percent improvement in FEV1 Post Dose for Period 1 over 4AM Baseline value) when 1 Puff go into chamber|fifteen minutes after 1 puff of albuterol|Study intended to get more subjects, but PI's review committee had to deal with candidate deadlines and a high rate of screen failures and allowed her to test seven subjects. Primary concern was the research experience, not the study questions. There was no bias in failing to meet accrual objectives thanks to the blinding.||Diff in % change from 4AM||Standard Error|Mean
817463|NCT01111123|Secondary|Signs of Psoriasis, Atrophy or Telangiectasis|Signs of psoriasis (erythema, induration, and scale) - physician's assessment of the severity of each of the three key characteristics of psoriatic lesions rated as: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, and 5=very severe, combined into one score.|During the maintenance phase, from 2 weeks up to 26 weeks|The primary endpoint was a change in PGA during the 24 weeks of the study in the ITT.||participants|||Number
817464|NCT01111123|Primary|Physical Global Assessment|Physician global assessment (PGA) score - the physician's impression of the disease at a single time point rated as: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, and 5=very severe.|During the maintenance phase, from 2 weeks up to 26 weeks|The primary endpoint was a change in PGA during the 24 weeks of the study in the intention-to-treat population (ITT).||participants|||Number
817465|NCT01111149|Secondary|Abnormal Movements - AIMS|Abnormal Involuntary Movement Scale (AIMS), to assess abnormal involuntary movements associated with antipsychotic drugs. There are 10 questions, based on a five-point scale ranging from 0 (none) to 4 (severe). Items 11-14 are yes/no questions that have no impact on the score. The Total Score is the sum of questions 1-7 (minimum = 0; maximum = 28). The severity index consists of one question (item 8; rated 0=none to 4=severe) based on the rater's observation of abnormal movements The AIMS Global Score is the sum of three questions (each item rated 0=none to 4=severe) regarding abnormal movements overall (minimum score 0, maximum score 12). For the total score and subscores, the higher the score, the greater the severity of abnormal movements. Scoring is based on the chapter: Guy W (2000), Abnormal Involuntary Movement Scale (AIMS), in: Handbook of Psychiatric Measures (Rush AJ Jr, et al., eds). APA Publishing: Washington DC: pp. 166-167.|Week 12|||units on a scale||Standard Deviation|Mean
817466|NCT01111149|Secondary|Urge to Smoke - MNWS|The Minnesota Nicotine Withdrawal Scale (MNWS) includes two items where individuals are asked to 1) declare the percentage of time they had an urge to smoke (MNWS % Urge to Smoke); and 2) declare the percentage of time they had a strong urge to smoke (MNWS % Strong Urge). For each case, percentages range from 0% to 100% - the higher the percentage, the greater urge to smoke.|Week 12|||percentage of time||Standard Deviation|Mean
817467|NCT01111149|Secondary|Abstinence Related Symptoms - WISDM|The Wisconsin Inventory of Smoking Dependence Motives (WISDM) consists of 68 items regarding smoking. Each item is rated on a scale of 1 (not true of me at all) to 7 (extremely true of me) leading to a minimum score of 68 and a maximum score of 476. The higher the score, the greater the dependence. Four of the items are grouped into a Craving subscale (minimum 4, maximum 28), the greater the score, the greater the craving. Five of the items are grouped into a Cognition subscale (minimum 5, maximum 35), the higher the score, the greater reliance on cigarette smoking for cognitive enhancement. WISDM scoring based on the original article by Piper et al., 2004. A multiple motives approach to tobacco dependence: the Wisconsin inventory of smoking dependence motives (WISDM-68). Journal of Consulting and Clinical Psychology 72:139-154.|Week 12|||units on a scale||Standard Deviation|Mean
817468|NCT01111149|Secondary|Response Style Indicator (Beta) for CPT|Beta represents an individual's response tendency: Some individuals are cautious and choose not to respond very often. Conceptually, such individuals want to make sure they are correct when they give a response. Higher values of Beta reflect this response style. The emphasis is on avoiding commission errors. Other individuals respond more freely to make sure they respond to most or all targets, and they tend to be less concerned about mistakenly responding to a non-target. Lower values of Beta are produced by this response style. Values shown below were obtained at week 12.|Week 12|||Beta||Standard Deviation|Mean
817469|NCT01111149|Secondary|Detectibility (d') of Continuous Performance Test|The value d' is a measure of the difference between the signal (non-X) and noise (X) distributions. As such, d' provides a means for assessing an individual's discriminative power since, in general, the greater the difference between the signal and noise distributions, the better the ability to distinguish and detect X and non-X stimuli. The lower the score, the better the detectability. Values shown below are for week 12.|Week 12|||unitless||Standard Deviation|Mean
817470|NCT01111149|Secondary|Variability of Standard Error - CPT|"Variability of Standard Error (VSE) is a measure of response speed consistency. VSE measures within respondent variability. That is, the amount of variability the individual shows in 18 separate segments of the Continuous Performance Test in relation to his or her own overall standard error. Although VSE is a different measure than Overall Standard Error, typically the two measures produce comparable results. The higher the VSE, the greater the inconsistency in the response speed. The values shown below are the VSE for Week 12."|Week 12|||milliseconds||Standard Deviation|Mean
827178|NCT01202253|Secondary|Percentage of Participants Who Received Water-based and Ethanol-based Formulation||Baseline|Full analysis set included all participants who met the defined eligibility criteria.||percentage of participants||95% Confidence Interval|Number
817472|NCT01111149|Secondary|General Psychopathology|Brief Psychiatric Rating Scale (BPRS), an 24-item scale measuring positive symptoms, general psychopathology, and affective symptoms commonly used for schizophrenia with each item rated on a scale of 1-7 with 1=not present and 7=severe. The minimum score is 24 and the maximum score is 168. We have used five subscales as recommended by Dingemans et al., 1995: Positive subscale (minimum score 6; maximum score 42); Negative subscale (minimum score 5; maximum score 35); Depressed subscale (minimum score 5; maximum score 35); Mania subscale (minimum score 6; maximum score 42); and Disorientation subscale (minimum score 2; maximum score 14) . For both the total score and the subscale scores, the higher the score, the greater the symptom severity. We used the BPRS version 4.0. Dingemans PMAJ, Linszen DH, Lenoir ME, Smeets RMW, 1995. Component structure of the expanded Brief Psychiatric Rating Scale (BPRS-E). Psychopharmacology 122:263-267.|Week 12|||units on a scale||Standard Deviation|Mean
817473|NCT01111149|Secondary|Positive Symptoms of Schizophrenia (SAPS)|Scale for the Assessment of Positive Symptoms (SAPS), a well-established test, used to assess the presence of psychotic symptoms of schizophrenia. There are 34 items rated on a scale of 0-5 with 0=none and 5=severe for a minimum score of 0 and a maximum score of 170. There are 4 subscales: Hallucinations (minimum score 0; maximum score 35); Delusions (minimum score 0; maximum score 65); Bizarre Behavior (minimum score 0; maximum score 25); Positive Formal Thought Disorder (minimum score 0; maximum score 45). Each subscale contains one additional question as a Global Rating - or overall measure for that particular subscale. The sum of these questions constitutes the Total Global Score (minimum 0, maximum 20). The values for the Global items are included in the Total Composite score. In each case, the higher the score, the greater the severity of symptoms.|Week 12|||units on a scale||Standard Deviation|Mean
817474|NCT01111149|Secondary|Suicidality|The Columbia-Suicide Severity Rating Scale (C-SSRS), is a survey intended to quantify the severity of suicidal ideation and behavior. The questionaire for suicidal ideation consists of 5 questions with yes (1) /no (0) answers. If answers to questions 1 and 2 are no, questions 3-5 are skipped. Minimum of 0; Maximum of 5. The questionaire for suicidal behavior consists of seven questions rated 0 for no and 1 for yes. The minimum score is 0 and the maximum score is 7. In each case, the higher the score, the greater the severity.|Week 12|||units on a scale||Standard Deviation|Mean
817475|NCT01111149|Secondary|Vital Signs - Pulse|Pulse will be measured. The values below were measured at week 12 of the study.|Week 12|||heart beats per minute||Standard Deviation|Mean
817476|NCT01111149|Primary|Smoking Abstinence - Exhaled Carbon Monoxide|Exhaled carbon monoxide as a biochemical verification of smoking abstinence. Values below are for week 12.|Week 12|||parts per million||Standard Deviation|Mean
817477|NCT01111149|Primary|Smoking Abstinence - Number of Cigarettes Smoked|Number of cigarettes smoked at week 12 of the study by self-report.|Week 12|||number of cigarettes smoked||Standard Deviation|Mean
817478|NCT01111149|Secondary|Vital Signs - Weight|Weight will be measured for each participant. Values listed below are for week 12.|Week 12|||lbs||Standard Deviation|Mean
817479|NCT01111149|Secondary|Vital Signs|blood pressure will be measured.|Week 12|||mm Hg||Standard Deviation|Mean
817480|NCT01111149|Secondary|Abnormal Movements - BAS and SAS|"Barnes Akathisia Scale (BAS), a widely-used measurement of drug-induced akathisia. It consists of 4 questions with questions 1-3 scored on a scale of 0-3 with 0=normal and 3=severe (minimum score 0, maximum score 9; while item 4 is a global clinical assessment of akathisia rated on a scale of 0 (normal) to 5 (severe). The higher the score on each subsclae, the greater the severity of akathisia.
Simpson-Angus Scale (SAS), a 10-item instrument used to evaluate patients experiencing neuroleptic-induced parkinsonism and other extrapyramidal side effects. Items are rated for severity on a 0-4 scale, with 0 being normal and 4 being severe. Minimum = 0; Maximum = 40. The higher the score, the greater the severity."|Week 12|||units on a scale||Standard Deviation|Mean
817481|NCT01111149|Secondary|Depression|Beck Depression Inventory (BDI), a self-report rating inventory measuring characteristic attitudes and symptoms of depression consisting of 21 items with each item rated on a four point scale (0=not present to 3=severe). The accepted ranges are as follows: 0 to 9 indicates no depression, 10 to 18 indicates mild to moderate depression, 19 to 29 indicates moderate to severe depression and 30 to 63 indicates severe depression.|Week 12|||units on a scale||Standard Deviation|Mean
817482|NCT01111149|Secondary|Abstinence-related Symptoms - MNWS and FTND|"Minnesota Nicotine Withdrawal Scale (MNWS), a patient-reported measure of nicotine withdrawal symptoms and cravings. Eight items are listed, including craving for cigarettes, irritability, frustration, or anger, anxiety, etc scored on a five point scale from 0 (normal) to 5 (severe). Patients are asked for responses for the past 24 hours and past seven days (minimum 0, maximum 32; for each subscale). The higher the score, the greater the dependence. Additionally, one question (minimum score 1, maximum score 4 measures the individual's confidence in resisting strong urges to smoke. The higher the score on this question, the greater the individual's confidence in resisting smoking urges.
The Fagerstrom Test for Nicotine Dependence measures nicotine dependence and consists of six questions with a total minimum score of 0 and a maximum score of 10. The higher the score, the greater the dependence on nicotine."|Week 12|||units on a scale||Standard Deviation|Mean
817483|NCT01111149|Secondary|Side Effects|Side effects will be monitored by a physician and/or assistant and recorded (SEP). All patients withdrawn from the study because of emerging side effects will be followed until the side effects are resolved. Each item is scored based on a scale of 0=none; 1=mild; 2=moderate; and 3=severe. Below, the data are shown for participants experiencing symptoms on week 12 of the study.|Week 12|||participants|||Number
817484|NCT01111149|Secondary|Impulsivity and Inattention|Impulsivity and inattention will be measured using the continuous performance test. Individuals were tasked with 359 items divided six blocks (59 in block 1, 60 in blocks 2-6). Omissions result from the failure to respond to target letters. CPT% Omissions measures the percentage of responses that qualify as omissions made during the test. Higher scores indicate increased inattention. Commissions result from responses given to non-targets. CPT% Commissions measures the percentage of responses that qualify as commissions made during the test. Higher scores indicate increased inattention. Perseverations result from reaction time less than 100 ms. CPT% Perseveration % measures the percentage of responses that qualify as perseverations made during the test. The higher the score, the greater impulsivity.|Week 12|||Percentage of responses||Standard Deviation|Mean
818306|NCT01118663|Secondary|To Evaluate the Incidence of Anaphylactoid Reaction.|Data analysis was conducted on the subjects enrolled in the study prior to study termination. Because the study was terminated prematurely due to lack of enrollment, there was an insufficient sample size to conduct an efficacy analysis.|1 hour|||participants|||Number
817485|NCT01111149|Secondary|Negative Symptoms of Schizophrenia - SANS|Scale for the Assessment of Negative Symptoms (SANS) a well-established test, used to assess the presence of psychosis or negative symptoms of schizophrenia. It consists of 25 questions rated on a scale of 0 (none) to 5 (severe). With a total score range of 0 to 125 points. There are 6 subscales: Affective Flattening or Blunting - (minimum, 0; maximum 35); Inappropriate Affect (minimum, 0; maximum 5); Alogia (minimum 0; maximum 25); Avolition-Apathy (minimum 0; maximum 20); Anhedonia-Asociality (minimum 0; maximum 25); Attention (minimum 0; maximum 15). Each subscale (except for Inappropriate Affect) contains one additional question as a Global Rating - or overall measure for that particular subscale. The sum of these questions constitutes the Total Global Score (minimum 0, maximum 25). The global questions are included within the Total Composite score. In each case, the larger the score, the more severe the symptoms.|Week 12|||units on a scale||Standard Deviation|Mean
817486|NCT01111149|Secondary|Reduction in Smoking|Successful outcome will be defined as a 50% or greater reduction in self-reported cigarettes per day and a 30% greater reduction in carbon monoxide and cotinine levels. Measured at week 12|Week 12|||participants|||Number
817487|NCT01111149|Primary|Smoking Abstinence - Serum/Urine Measurements|Measured by blood/urine tests for nicotine and its break-down product cotinine.|Week 12|||ng/mL||Standard Deviation|Mean
817488|NCT01111162|Primary|Immunogenicity|Immunologic response, defined as HAI titer ≥ 1:40, at 21 days after vaccine dose.|21-28 days|Among the 90 participants without evidence of previous exposure to H1N1, only 61% [95% confidence interval (CI) 51–71] developed protective titers by week 3 of the study (seroconversion rate).||percentage of seroconversion||95% Confidence Interval|Number
817489|NCT01111162|Primary|Safety|"To assess the safety of inactivated swine-origin H1N1 influenza vaccine in HIV-1 infected individuals (received as part of standard of care).
Safety was assessed via
Adverse Events of Grade 3 or higher of abnormal laboratory values, signs and symptoms or diagnoses.
Solicited local AEs, including pain, tenderness, redness, and swelling post each vaccination. Solicited systemic AEs, including feverishness, malaise, body aches (exclusive of the injection site), nausea, and headache post each vaccination."|21-28 days|||percentage of participants|||Number
817490|NCT01111240|Secondary|Percentage of Participants on Concomitant Systemic Rheumatic and Pain Relief Medication|Prior and concomitant non-biologic disease-modifying antirheumatic drugs (DMARDs): methotrexate (MTX) and other DMARDs|Baseline, and Months 6 and 24|FAS||percentage of participants|||Number
817491|NCT01111240|Secondary|Percentage of Participants With In-Patient Hospitalization|Percentage of participants with in-patient hospitalization were derived from patient recall of events in the preceding 12 months (at Baseline), in the preceding 3 months (at months 3, 6, 9, and 12), or in the preceding 6 months (at months 18 and 24).|Baseline, and Months 3, 6, 9, 12, 18, and 24|Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.||percentage of particpants|||Number
817492|NCT01111240|Secondary|Mean Number of Days Missed From Work Due to Psoriatic Arthritis|Mean number of days missed from work were derived from patient recall of events in the preceding 12 months (at baseline), in the preceding 3 months (at months 3, 6, 9, and 12), or in the preceding 6 months (at months 18 and 24).|Baseline, and Months 3, 6, 9, 12, 18, and 24|Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.||days||Standard Deviation|Mean
817493|NCT01111240|Secondary|Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks of Each Visit||Baseline, and Months 3, 6, 9, 12, 18, and 24|Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.||percentage of participants|||Number
817494|NCT01111240|Secondary|Mean Funktionsfragebogen Hannover (FFbH) Questionnaire Scores Over Time|A self-administered participant questionnaire used to assess patient function on a scale of 0 (total loss of functional capacity) to 100 (maximal functional capacity) units; the FFbH score indicates the remaining percentage of participant function.|Baseline, and Months 3, 6, 9, 12, 18, and 24|Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.||scores on a scale||Standard Deviation|Mean
817495|NCT01111240|Secondary|Participants Assessment of Pain Over Time|Measured on a visual analog scale (VAS) of 0 to 10 cm; lower scores indicate better participant’s status.|Baseline, and Months 3, 6, 9, 12, 18, and 24|Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.||scores on a scale||Standard Deviation|Mean
817496|NCT01111240|Secondary|Participants Assessment of Fatigue Over Time|Measured on a visual analog scale (VAS) of 0 to 10 cm; lower scores indicate better participant’s status.|Baseline, and Months 3, 6, 9, 12, 18, and 24|Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.||scores on a scale||Standard Deviation|Mean
817497|NCT01111240|Secondary|Patients Global Assessment of Disease Activity Over Time|Measured on a visual analog scale (VAS) of 0 to 10 cm; lower scores indicate better participant’s status.|Baseline, and Months 3, 6, 9, 12, 18, and 24|Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.||scores on a scale||Standard Deviation|Mean
817498|NCT01111240|Secondary|Mean C-Reactive Protein (CRP) Levels Over Time|The C-Reactive Protein (CRP) is an acute phase reactant plasma protein, normally produced by the liver, which is commonly used as an indirect measure of the extent and activity of an inflammation. The CRP normal reference range in the blood is, as a rule, from 0 to 1.0 mg/dL.|Baseline, and Months 3, 6, 9, 12, 18, and 24|Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.||mg/L||Standard Deviation|Mean
817499|NCT01111240|Secondary|Mean Erythrocyte Sedimentation Rate (ESR) Over Time|The Erythrocyte Sedimentation Rate (ESR) is a practicable and sensitive but not specific parameter for measuring disease progression. By means of the ESR it can be generally distinguished between an active and nonactive rheumatic disease. The normal reference range is, as a rule, 0 to 10 mm/h for men and 0 to 15 mm/h for women. The higher the ESR value out of the normal range, the higher is the disease activity.|Baseline, and Months 3, 6, 9, 12, 18, and 24|Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.||mm/hour||Standard Deviation|Mean
817500|NCT01111240|Secondary|Number of Participants by Severity of Nail Psoriasis Levels Over Time|Nail psoriasis is a distinguishing characteristic of PsA. Nail psoriasis is characterized by changes in the nail and nail matrix, including pitting, onycholysis (painless separation of the nail from the nail bed), and reddish spots. Investigators reported the presence or absence of nail psoriasis on the basis of their clinical evaluation; no specific scale or score was used. If present, the severity of this condition was graded by the investigator on a scale of mild, moderate, and severe based on their clinical impression.|Baseline, and Months 3, 6, 9, 12, 18, and 24|Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.||participants|||Number
817501|NCT01111240|Secondary|Number of Participants by Severity of Dactylitis Over Time|Dactylitis is a distinguishing characteristic of PsA. Dactylitis, sometimes referred to “sausage digit,” involves swelling of the entire finger. Investigators reported the presence or absence of dactylitis on the basis of their clinical evaluation; no specific scale or score was used. If present, the severity of each condition was graded by the investigator on a scale of mild, moderate, and severe based on their clinical impression.|Baseline, and Months 3, 6, 9, 12, 18, and 24|Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.||participants|||Number
817502|NCT01111240|Secondary|Number of Participants by Severity of Enthesitis Over Time|Enthesitis is a distinguishing characteristic of PsA. Enthesitis involves inflammation at the site where tendons and other connective tissues enter the bone. Investigators reported the presence or absence of enthesitis on the basis of their clinical evaluation; no specific scale or score was used. If present, the severity of each condition was graded by the investigator on a scale of mild, moderate, and severe based on their clinical impression.|Baseline, and Months 3, 6, 9, 12, 18, and 24|Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.||participants|||Number
817503|NCT01111240|Primary|Number of Participants With Adverse Events (AEs)|Adverse Events (AEs) were reported that clinicians considered to be related to the study drug. An AE was considered to be a serious adverse event (SAE) if any of the following criteria were met: Death of participant, life-threatening event, hospitalization, prolongation of hospitalization, congenital anomaly, persistent or significant disability or incapacity, important medical event requiring medical or surgical intervention to prevent serious outcome, or spontaneous or elective abortion.|Baseline up to 24 months|Safety Set - All enrolled participants||participants|||Number
817504|NCT01111240|Primary|Mean Target Lesion Score (TLS) Over Time|The Target Lesion Score (TLS) was based on the severity of erythema, scaling, and infiltration of a prospectively-defined psoriasis target lesion of at least 2 cm in width that was considered to be representative of all other affected areas. Each of the three characteristics was evaluated by the clinician on a scale of 0 (absent) to 5 (maximal expression), and these scores were totaled to provide a TLS ranging from 0 (lowest severity) to 15 (highest severity).|Baseline, and Months 3, 6, 9, 12, 18, and 24|Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.||score on a scale||Standard Deviation|Mean
817505|NCT01111240|Primary|Mean Percent Body Surface Area (BSA) Affected by Psoriasis Over Time|Body surface area was used to evaluate the extent of psoriatic skin involvement. At baseline, investigators classified participants as having BSA less than 3%, 3 to 10%, 11 to 20%, or greater than 20%. At all post-baseline time points, clinicians were asked to estimate BSA on a scale of 0% to 100% rather than as categories. BSA was visually determined by the investigator using the 'rule of nines' and estimating that the palm of the patient’s hand was equal to 1% BSA.|Baseline, and Months 3, 6, 9, 12, 18, and 24|Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.||percentage of body surface area||Standard Deviation|Mean
817506|NCT01111240|Primary|Mean Swollen Joint Count (SJC) Over Time|Swollen joint count represents the number of joints displaying swelling. Although the DAS28 includes assessments of 28 joints, additional joints are typically evaluated in examinations of participants with Psoriatic Arthritis (PsA) as the joints typically affected in these participants differ from those commonly involved in Rheumatoid Arthritis (RA). Specifically, PsA often involves distal interphalangeal joints (DIP), whereas RA does not.|Baseline, and Months 3, 6, 9, 12, 18, and 24|Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.||Swollen Joints||Standard Deviation|Mean
817507|NCT01111240|Primary|Mean Tender Joint Count (TJC) Over Time|Tender joint count represents the number of joints displaying tenderness. Although the DAS28 includes assessments of 28 joints, additional joints are typically evaluated in examinations of participants with Psoriatic Arthritis (PsA) as the joints typically affected in these participants differ from those commonly involved in Rheumatoid Arthritis (RA). Specifically, PsA often involves distal interphalangeal joints (DIP), whereas RA does not.|Baseline, and Months 3, 6, 9, 12, 18, and 24|Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.||Tender joints||Standard Deviation|Mean
817508|NCT01111240|Primary|Mean Change From Baseline in Disease Activity Score (DAS)28|The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score greater than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission.|Baseline and Months 3, 6, 9, 12, 18, and 24|Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.||score on a scale||Standard Deviation|Mean
817522|NCT01111318|Secondary|Terminal Half-Life (t1/2)|"Terminal half-life of empagliflozin (empa) in plasma.
The standard deviation is actually the coefficient of variation."|Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration|Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.||h||Standard Deviation|Mean
817509|NCT01111292|Primary|The Effect of Myo-inositol (Inositol) on P-β-catenin Staining in Areas of Low Grade Dysplasia in Subjects With Known Colitis-induced Low Grade Dysplasia.|The primary objective of this study will be to evaluate the effect of myo-inositol (inositol), administered for three months, on P-β-catenin staining in areas of low grade dysplasia or in areas of prior low grade dysplasia in subjects with known colitis-induced low grade dysplasia at baseline.|Baseline to 90 days|pβ-cat-positive cell counts in pre- and post-study biopsies with dysplasia or adenoma. Counts are broken down as the number of crypts with 3, 4, or 5 pβ-cat positive cells. High frequency (HF) fields of view are those containing at least 2 crypts with three or more pβ-cat positive cells per crypt (at 20X). I||Colonic Biopsies||Standard Deviation|Mean
817514|NCT01111318|Secondary|Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Clinical Laboratory Tests and Assessment of Tolerability by the Investigator|Clinically relevant abnormalities for physical examination, vital signs, ECG, clinical laboratory tests and assessment of tolerability by the investigator. New abnormal findings or worsening of baseline conditions were reported as Adverse Events (AE).|Drug administration until 4 days after drug administration or end-of-study visit, up to 19 days|Treated Set (TS) included all subjects who had been dispensed study medication and were documented to have taken the investigational treatment.||participants|||Number
817515|NCT01111318|Secondary|Urinary Glucose Excretion (UGE)|"Urinary glucose excretion, this endpoint was measured using Ae0-96.
The standard deviation is actually the coefficient of variation."|Pre-dose and time intervals 0-4h, 4-8h, 8-12h, 12-24h, 24-36h, 36-48h, 48-72h and 72-96h after drug administration|Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.||mg||Standard Deviation|Mean
817516|NCT01111318|Secondary|Renal Clearance After Extravascular Administration (CL R)|"Renal clearance of empagliflozin (empa) in plasma after extravascular administration.
The standard deviation is actually the coefficient of variation."|Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration|Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.||mL/min||Standard Deviation|Mean
817517|NCT01111318|Secondary|Fraction of Empagliflozin Excreted Unchanged in Urine (fe0-96))|"Fraction of empagliflozin (empa) excreted unchanged in urine from time points 0 to 96 hours.
The standard deviation is actually the coefficient of variation."|Pre-dose and time intervals 0-4h, 4-8h, 8-12h, 12-24h, 24-36h, 36-48h, 48-72h and 72-96h after drug administration|Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.||percentage of empagliflozin||Standard Deviation|Mean
817518|NCT01111318|Secondary|Amount of Empagliflozin That is Eliminated in Urine (Ae0-96)|"Amount of empagliflozin (empa) that is eliminated in urine over the time interval 0 to 96 hours.
The standard deviation is actually the coefficient of variation."|Pre-dose and time intervals 0-4h, 4-8h, 8-12h, 12-24h, 24-36h, 36-48h, 48-72h and 72-96h after drug administration|Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.||nmol||Standard Deviation|Mean
817519|NCT01111318|Secondary|Apparent Volume of Distribution During the Terminal Phase (Vz/F)|"Apparent volume of distribution during the terminal phase (λz).
The standard deviation is actually the coefficient of variation."|Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration|Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.||L||Standard Deviation|Mean
817520|NCT01111318|Secondary|Apparent Clearance After Extravascular Administration (CL/F)|"Apparent clearance of empagliflozin (empa) in the plasma after extravascular administration.
The standard deviation is actually the coefficient of variation."|Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration|Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.||mL/min||Standard Deviation|Mean
817521|NCT01111318|Secondary|Mean Residence Time (MRTpo)|"Mean residence time of empagliflozin (empa) in the body.
The standard deviation is actually the coefficient of variation."|Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration|Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.||h||Standard Deviation|Mean
818307|NCT01118663|Secondary|To Evaluate the Incidence of Treatment Emergent Adverse Events||21-42 hours|||Number of Events|||Number
817523|NCT01111318|Secondary|Terminal Rate Constant (λz)|"Terminal rate constant in plasma.
The standard deviation is actually the coefficient of variation."|Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration|Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.||1/h||Standard Deviation|Mean
817524|NCT01111318|Secondary|Time From Dosing to Maximum Concentration (Tmax)|Time from dosing to maximum concentration of empagliflozin (empa) in plasma.|Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration.|Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.||h||Full Range|Median
817525|NCT01111318|Secondary|Area Under the Curve 0 to Time of Last Quantifiable Data Point (AUC0-tz)|"Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 to the time of the last quantifiable data point.
The standard deviation is actually the coefficient of variation."|Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration.|Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.||nmol*h/L||Standard Deviation|Mean
817526|NCT01111318|Primary|Maximum Measured Concentration (Cmax)|"Maximum measured concentration of empagliflozin (empa) in plasma.
The standard deviation is actually the coefficient of variation. The 'measured values' show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration|Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.||nmol/L||Standard Deviation|Mean
817527|NCT01111318|Primary|Area Under the Curve 0 to Infinity (AUC0-∞)|"Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity.
The standard deviation is actually the coefficient of variation. The 'measured values' show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration|Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.||nmol*h/L||Standard Deviation|Mean
817528|NCT01111331|Secondary|Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Blood Chemistry and Assessment of Tolerability by Investigator|Clinically relevant abnormalities for physical examination, vital signs, ECG, blood chemistry and assessment of tolerability by investigator. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.|Drug administration until beginning of next sequence/end of trial, 35 days|Treated set (TS) included all subjects who had taken at least one dose of trial medication.||participants|||Number
817529|NCT01111331|Secondary|Warfarin: Area Under the PT-time Curve From 0 to Last Measurable Data Point Adjusted to Baseline (PT AUEC0-tz,Base)|Area under the PT-time curve from time of dosing to time of last measurable data point adjusted for baseline value (before any trial drug administration) of area under the PT-time curve|0 hours (h), 1h, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacodynamic (PD) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one PD endpoint without an important protocol violation with respect to the PD evaluation.||s*hr||95% Confidence Interval|Geometric Mean
817530|NCT01111331|Secondary|Warfarin: Peak Prothrombin Time Adjusted to Baseline (PTmax,Base)|Peak prothrombin time adjusted for baseline value (before any trial drug administration) of peak prothrombin|0 hours (h), 1h, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacodynamic (PD) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one PD endpoint without an important protocol violation with respect to the PD evaluation.||s||95% Confidence Interval|Geometric Mean
817531|NCT01111331|Secondary|Warfarin: Area Under the PT-time Curve From 0 to Last Measurable Data Point (PT AUEC0-tz)|Area under the PT-time curve from time of dosing to time of last measurable data point|0 hours (h), 1h, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacodynamic (PD) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one PD endpoint without an important protocol violation with respect to the PD evaluation.||s*hr||95% Confidence Interval|Geometric Mean
817532|NCT01111331|Secondary|Warfarin: Area Under the INR-time Curve From 0 to Last Measurable Data Point Adjusted to Baseline (INR AUEC0-tz,Base)|Area under the INR-time curve from time of dosing to time of last measurable data point adjusted for baseline value (before any trial drug administration) of area under the INR-time curve|0 hours (h), 1h, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacodynamic (PD) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one PD endpoint without an important protocol violation with respect to the PD evaluation.||ratio*h||95% Confidence Interval|Geometric Mean
818240|NCT01118117|Secondary|Procedural Success|Procedural success defined as: attainment of < 30% residual stenosis of the target lesion and no peri-procedural complications defined as: death, stroke, myocardial infarction, emergent surgical revascularization, significant distal embolization in target limb, and thrombosis of target vessel|Intra-procedure|||percentage of subjects with success|||Number
817533|NCT01111331|Secondary|Warfarin: Peak Prothrombin Time (PTmax)|Peak prothrombin time|0 hours (h), 1h, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacodynamic (PD) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one PD endpoint without an important protocol violation with respect to the PD evaluation.||s||95% Confidence Interval|Geometric Mean
817534|NCT01111331|Secondary|Warfarin: Peak International Normalised Ratio Adjusted to Baseline (INRmax,Base)|Peak international normalised ratio for warfarin adjusted for baseline value (before any trial drug administration) of peak international normalised ratio|0 hours (h), 1h, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacodynamic (PD) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one PD endpoint without an important protocol violation with respect to the PD evaluation.||Ratio||95% Confidence Interval|Geometric Mean
817535|NCT01111331|Secondary|Warfarin: Area Under the INR-time Curve From 0 to Last Measurable Data Point (INR AUEC0-tz)|Area under the concentration time curve of the INR measurements over the time interval from 0 to the time of the last quantifiable data point.|0 hours (h), 1h, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacodynamic (PD) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one PD endpoint without an important protocol violation with respect to the PD evaluation.||ratio*h||95% Confidence Interval|Geometric Mean
817536|NCT01111331|Secondary|Warfarin: Peak International Normalised Ratio (INRmax)|Peak international normalised ratio for warfarin, measured as the maximum INR over time.|0 hours (h), 1h, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacodynamic (PD) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one PD endpoint without an important protocol violation with respect to the PD evaluation.||Ratio||95% Confidence Interval|Geometric Mean
817537|NCT01111331|Secondary|Warfarin S-enantiomers: Apparent Volume of Distribution Following Extravascular Administration (Vz/F)|Apparent volume of distribution during the terminal phase λz following extravascular administration|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.||L||Geometric Coefficient of Variation|Geometric Mean
817538|NCT01111331|Secondary|Warfarin S-enantiomers: Apparent Clearance After Extravascular Administration (CL/F)|Apparent clearance in plasma after extravascular administration|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.||mL/min||Geometric Coefficient of Variation|Geometric Mean
817539|NCT01111331|Secondary|Warfarin S-enantiomers: Mean Residence Time After Oral Administration (MRTpo)|Mean residence time of the analyte in the body after oral administration|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.||h||Geometric Coefficient of Variation|Geometric Mean
817540|NCT01111331|Secondary|Warfarin S-enantiomers: Terminal Half-life (t1/2)|Terminal half-life of the analyte in plasma|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.||h||Geometric Coefficient of Variation|Geometric Mean
817541|NCT01111331|Secondary|Warfarin S-enantiomers: Terminal Rate Constant (λz)|Terminal rate constant in plasma|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.||1/h||Geometric Coefficient of Variation|Geometric Mean
817542|NCT01111331|Secondary|Warfarin S-enantiomers: Time to Maximum Plasma Concentration (Tmax)|Time from dosing until maximum plasma concentration is reached|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.||h||Full Range|Median
817543|NCT01111331|Secondary|Warfarin S-enantiomers: Area Under the Curve 0 to Last Measurable Data Point (AUC0-tz)|Area under the plasma concentration-time curve from time of dosing to time of last measurable data point.|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
818241|NCT01118117|Secondary|Technical Success|"Technical Success defined by the following conditions:
Successful delivery of the stent at the lesion site
Stent(s) successfully deployed in lesion with adequate lesion coverage"|Intra-procedure|All subjects enrolled in pivotal trial||percentage of subjects with success|||Number
817544|NCT01111331|Secondary|Warfarin R-enantiomers: Apparent Volume of Distribution Following Extravascular Administration (Vz/F)|Apparent volume of distribution during the terminal phase λz following extravascular administration|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.||L||Geometric Coefficient of Variation|Geometric Mean
817545|NCT01111331|Secondary|Warfarin R-enantiomers: Apparent Clearance After Extravascular Administration (CL/F)|Apparent clearance in plasma after extravascular administration|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.||mL/min||Geometric Coefficient of Variation|Geometric Mean
817546|NCT01111331|Secondary|Warfarin R-enantiomers: Mean Residence Time After Oral Administration (MRTpo)|Mean residence time of the analyte in the body after oral administration|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.||h||Geometric Coefficient of Variation|Geometric Mean
817547|NCT01111331|Secondary|Warfarin R-enantiomers: Terminal Half-life (t1/2)|Terminal half-life of the analyte in plasma|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.||h||Geometric Coefficient of Variation|Geometric Mean
817548|NCT01111331|Secondary|Warfarin R-enantiomers: Terminal Rate Constant (λz)|Terminal rate constant in plasma|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.||1/h||Geometric Coefficient of Variation|Geometric Mean
817549|NCT01111331|Secondary|Warfarin R-enantiomers: Time to Maximum Plasma Concentration (Tmax)|Time from dosing until maximum plasma concentration is reached|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.||h||Full Range|Median
817550|NCT01111331|Secondary|Warfarin R-enantiomers: Area Under the Curve 0 to Last Measurable Data Point (AUC0-tz)|Area under the plasma concentration-time curve from time of dosing to time of last measurable data point.|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
817551|NCT01111331|Secondary|Empagliflozin: Apparent Volume of Distribution Following Extravascular Administration (Vz/F,ss)|"Apparent volume of distribution during the terminal phase at steady state following extravascular administration.
In addition to the below time frame, pre-dose samples were collected on Days 1, 3, and 4 for empa and a post-dose sample on day 1 for empa plus warfarin."|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h post-dose on Day 5 for for empa; 0h, 20min, 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h for empa plus warfarin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.||L||Geometric Coefficient of Variation|Geometric Mean
817552|NCT01111331|Secondary|Empagliflozin: Apparent Clearance at Steady State (CL/F,ss)|"Apparent clearance in plasma after extravascular administration at steady state.
In addition to the below time frame, pre-dose samples were collected on Days 1, 3, and 4 for empa and a post-dose sample on day 1 for empa plus warfarin."|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h post-dose on Day 5 for for empa; 0h, 20min, 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h for empa plus warfarin.|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.||mL/min||Geometric Coefficient of Variation|Geometric Mean
817553|NCT01111331|Secondary|Empagliflozin: Mean Residence Time at Steady State After Oral Administration (MRTpo,ss)|"Mean residence time of empagliflozin (empa) in the body at steady state after oral administration.
In addition to the below time frame, pre-dose samples were collected on Days 1, 3, and 4 for empa and a post-dose sample on day 1 for empa plus warfarin."|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h post-dose on Day 5 for for empa; 0h, 20min, 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h for empa plus warfarin.|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.||h||Geometric Coefficient of Variation|Geometric Mean
834868|NCT01280604|Primary|Triglyceride Levels|Triglyceride levels will be assessed in study participants 6-10 weeks after entry into study.|6-10 weeks|||milligram/deciliter||Standard Deviation|Mean
817554|NCT01111331|Secondary|Empagliflozin: Time to Maximum Plasma Concentration at Steady State (Tmax,ss)|"Time from last dosing to maximum plasma concentration at steady state over a uniform dosing interval τ.
In addition to the below time frame, pre-dose samples were collected on Days 1, 3, and 4 for empa and a post-dose sample on day 1 for empa plus warfarin."|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h post-dose on Day 5 for for empa; 0h, 20min, 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h for empa plus warfarin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.||h||Full Range|Median
817555|NCT01111331|Secondary|Empagliflozin: Terminal Half-life at Steady State (t1/2,ss)|"Terminal half-life of empagliflozin (empa) in plasma at steady state.
In addition to the below time frame, pre-dose samples were collected on Days 1, 3, and 4 for empa and a post-dose sample on day 1 for empa plus warfarin."|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h post-dose on Day 5 for for empa; 0h, 20min, 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h for empa plus warfarin.|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.||h||Geometric Coefficient of Variation|Geometric Mean
817556|NCT01111331|Secondary|Empagliflozin: Terminal Rate Constant at Steady State (λz,ss)|"Terminal rate constant of empagliflozin (empa) in plasma at steady state.
In addition to the below time frame, pre-dose samples were collected on Days 1, 3, and 4 for empa and a post-dose sample on day 1 for empa plus warfarin."|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h post-dose on Day 5 for for empa; 0h, 20min, 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h for empa plus warfarin.|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.||1/h||Geometric Coefficient of Variation|Geometric Mean
817557|NCT01111331|Secondary|Empagliflozin: Plasma Concentration 24 Hours After Administration of Dose (C24,N)|Plasma concentration of empagliflozin (empa) measured 24 hours after administration of the fourth dose (Cpre,5) and after the sixth dose (Cpre,7).|24 hours after dose 4 or 6 respectively (day 5 and day 7)|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
817558|NCT01111331|Primary|Warfarin S-enantiomers: Maximum Measured Concentration (Cmax)|Maximum measured concentration of the analyte in plasma|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
817559|NCT01111331|Primary|Warfarin S-enantiomers: Area Under the Curve 0 to Infinity (AUC0-∞)|Area under the plasma concentration-time curve from time of dosing extrapolated to infinity.|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
817560|NCT01111331|Primary|Warfarin R-enantiomers: Maximum Measured Concentration (Cmax)|Maximum measured concentration of the analyte in plasma.|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
817561|NCT01111331|Primary|Warfarin R-enantiomers: Area Under the Curve 0 to Infinity (AUC0-∞)|Area under the plasma concentration-time curve from time of dosing extrapolated to infinity.|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
817562|NCT01111331|Primary|Empagliflozin: Maximum Measured Concentration at Steady State(Cmax,ss)|"Maximum measured plasma concentration of empagliflozin (empa) for the dosing interval τ at steady state.
In addition to the below time frame, pre-dose samples were collected on Days 1, 3, and 4 for empa and a post-dose sample on day 1 for empa plus warfarin."|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h post-dose on Day 5 for for empa; 0h, 20min, 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h for empa plus warfarin.|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
817583|NCT01111526|Primary|Phase I: Maximum Tolerated Dose (MTD) in Milligrams|MTD of LBH589 in addition to glucocorticoids as treatment for Graft Versus Host Disease (GVHD) manifestations. MTD in Milligrams (mg), taken by mouth (PO), 3 times per week, for 4 weeks. The oral formulation replaced the IV formulation (which became unavailable) after the first 4 participants were treated. Dose limiting toxicity (DLT) is defined by the occurrence of Common Toxicity Criteria (CTC) grade 3 or greater toxicity that is unexpected with transplantation, except for hematological toxicity, where DLT is defined as absolute neutrophil count (ANC) <750, and for those participants who were platelet transfusion independent is defined as platelets <10 K.|2 years, 8 months|All participants treated with Oral Formulation LBH589, during Phase I Dose Escalation.||MTD of oral LBH589 in milligrams|||Number
817563|NCT01111331|Primary|Empagliflozin: Area Under the Curve for the Dosing Interval at Steady State (AUCτ,ss)|"Area under the plasma concentration-time curve for the dosing interval τ at steady state
In addition to the specified time frame, pre-dose samples were collected on Days 1, 3, and 4 for empa and a post-dose sample on day 1 for empa plus warfarin."|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h post-dose on Day 5 for for empa; 0h, 20min, 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h for empa plus warfarin.|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
817564|NCT01111370|Primary|the Proportion of G4 CGM System in Agreement With the Reference Standard|The proportion of G4 System values within (±) 20% of YSI reference value for glucose levels >80 mg/dL and (±) 20 mg/dL at YSI glucose levels <80 mg/dL. This is primarayly laboratory measurement outcome,and it is not measured by clinical outcome, for example, diagnosis, treatement and complication, and clinical effectiveness, etc.|Assessment done on either Day 1, 4 or 7 of the sensor wear period|Randomly enrolled||%20/20||95% Confidence Interval|Mean
817565|NCT01111461|Other Pre-specified|Percentage Change From Baseline in the Apparent Diffusion Coefficient (ADC) Median|The antiangiogenic and direct antitumor effects of lenvatinib were assessed by analyses of two DCE-MRI/DWI MRI scans obtained on evaluable participants at Baseline and Cycle 1 Day 5. The scans were obtained using standardized acquisition across sites. DWI sequences totaling approximately 30 seconds were acquired during the DCE-MRI scans. Centralized analysis metrics for DCE-MRI included the percentage change in ADC for gadolinium chelate movement from the vasculature into the tissue extracellular space from baseline.|Cycle 1 Day 5|Imaging biomarker analysis set included those participants who received at least 1 dose of lenvatinib and had, at a minimum, a baseline and 1 postbaseline evaluable imaging assessment. n = 2 participants with evaluable data.||Percentage change||Standard Deviation|Mean
817566|NCT01111461|Other Pre-specified|Percentage Change From Baseline in the Contrast Volume Transfer Coefficient (Ktrans) Median|The antiangiogenic and direct antitumor effects of lenvatinib were assessed by analyses of two DCE-MRI/DWI MRI scans obtained on evaluable participants at Baseline and Cycle 1 Day 5. The scans were obtained using standardized acquisition across sites. DWI sequences totaling approximately 30 seconds were acquired during the DCE-MRI scans. Centralized analysis metrics for DCE-MRI included the percentage change in Ktrans for gadolinium chelate movement from the vasculature into the tissue extracellular space from baseline.|Cycle 1 Day 5|Imaging biomarker analysis set included those participants who received at least 1 dose of lenvatinib and had, at a minimum, a baseline and 1 postbaseline evaluable imaging assessment. n = 4 participants with evaluable data.||Percentage change||Standard Deviation|Mean
817567|NCT01111461|Other Pre-specified|Percentage Change From Baseline for the Imaging Biomarker Parameter of the Area Under the Plasma Concentration Curve Blood Normalized (90) (AUCBN (90)) Median for Total Volume|The antiangiogenic and direct antitumor effects of lenvatinib were assessed by analyses of 2 dynamic contrast-enhanced magnetic resonance imaging/diffusion-weighted magnetic resonance imaging (DCE-MRI/DWI MRI) scans obtained on evaluable participants at Baseline and Cycle 1 Day 5. The scans were obtained using standardized acquisition across sites. DWI sequences totaling approximately 30 seconds were acquired during the DCE-MRI scans. Centralized analysis metrics for DCE-MRI included percentage change in initial area under the gadolinium contrast agent time-concentration curve (first 90 seconds, blood normalized) from baseline.|Cycle 1 Day 5|Imaging biomarker analysis set included those participants who received at least 1 dose of lenvatinib and had, at minimum, a baseline and 1 postbaseline evaluable imaging assessment. n = 4 participants with evaluable data.||Percentage change||Standard Deviation|Mean
817568|NCT01111461|Other Pre-specified|Summary of Plasma Concentration of Lenvatinib|A total of 6 blood samples for pharmacokinetic (PK) analysis were collected from each participant who received lenvatinib once daily.|Predose and 2 hours postdose on Cycle 1 Day 1, Cycle 1 Day 8, and Cycle 2 Day 1|PK analysis set was used and included all participants with an evaluable plasma concentration.||ng/mL||Standard Deviation|Mean
817569|NCT01111461|Secondary|Number of Participants With Adverse Events (AEs) /Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Lenvatinib Tolerability of Lenvatinib|Safety was assessed by monitoring and recording all AEs and SAEs, regular monitoring of hematology, clinical chemistry, and urine values, regular measurement of vital signs, electrocardiograms (ECGs), and echocardiograms.|From the administration of first dose up to 30 days after the last dose, or up to data cut-off (21 May 2012), or up to approximately 26 months.|Safety Analysis Set included all participants who received at least 1 dose of lenvatinib and had at least 1 postbaseline safety evaluation. This was the analysis set for all safety evaluations.||Participants|||Number
817570|NCT01111461|Secondary|Clinical Benefit Rate (CBR)|CBR was defined as the percentage of participants with BOR of CR or PR or durable stable disease (dSD) [CR + PR + dSD] based on RECIST 1.1. The dSD rate was defined as the percentage of participants with dSD (based on RECIST 1.1 and defined as SD lasting greater than or equal to 23 weeks), as determined by the IRR and Investigator.|From date of first administration of study treatment until the date of first documentation of disease progression or date of death, if death occurred prior to disease progression, or up to approximately 26 months (as of 21 May 2012 data cut-off)|Full Analysis Set (ITT Population) included all participants who received at least 1 dose of lenvatinib.||Percentage of participants||95% Confidence Interval|Number
817571|NCT01111461|Secondary|Disease Control Rate (DCR)|DCR was defined as the percentage of participants with BOR of CR or PR or stable disease (SD) based on RECIST 1.1 and SD lasting greater than or equal to 7 weeks, as determined by IRR and Investigator.|From date of first administration of study treatment until the date of first documentation of disease progression or date of death, if death occurred prior to disease progression, or up to approximately 26 months (as of 21 May 2012 data cut-off)|Full Analysis Set (ITT Population) included all participants who received at least 1 dose of lenvatinib.||Percentage of participants||95% Confidence Interval|Number
817584|NCT01111838|Primary|To Determine Overall Objective Response.|Patients with measurable disease will be evaluated using RECIST criteria for determination of response.|every 8 weeks|||participants|||Number
817585|NCT01111851|Secondary|Brain NK1-receptor Occupancy at 120 Hours Post Dose||120 hours post dose|"All participants with at least 1 successful postdose PET
scan were included in the analysis population."||Percent of occupancy||95% Confidence Interval|Geometric Mean
817572|NCT01111461|Secondary|Overall Survival (OS)|OS was the length time in months from the date of first treatment until the date of death from any cause. If death was not observed, OS was censored at the last known alive date or data cut-off. Additional survival follow-up data was collected for all participants who had not withdrawn consent and were alive at the time of the initial survival follow-up as of 26 Nov 2012 data cut-off. Participants who were lost to follow-up at the time of the initial assessment may have been contacted again at the investigator's discretion. Updated survival (based on 26 Nov 2012 cut-off) was derived for these participants if the contact was made successfully.|From date of first administration of study treatment until the date of death, or up to approximately 32 months (as of 26 Nov 2012 data cut-off)|Full Analysis Set (ITT Population) included all participants who received at least 1 dose of lenvatinib.||Months||95% Confidence Interval|Median
817573|NCT01111461|Secondary|Progression Free Survival (PFS)|PFS was measured as the time from the date of first administration of study treatment until the date of first documentation of disease progression or date of death (whichever occurred first), as determined by independent radiologic review (IRR) and Investigator based on RECIST 1.1. Disease progression per RECIST v1.1 was defined as at least a 20% relative increase and 5 mm absolute increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions.|From date of first administration of study treatment until the date of first documentation of disease progression or date of death, if death occurred prior to disease progression or up to approximately 26 months (as of 21 May 2012 data cut-off)|Full Analysis Set (ITT Population) included all participants who received at least 1 dose of lenvatinib.||Months||95% Confidence Interval|Median
817574|NCT01111461|Primary|Objective Response Rate (ORR)|ORR was defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 for target lesions assessed by magnetic resonance imaging/computed tomography (MRI/CT) scans, as determined by independent radiologic review. BOR of CR was confirmed by a subsequent CR assessment at least 4 weeks later. BOR of PR was confirmed by a subsequent CR or PR assessment at least 4 weeks later. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (target or non-target) had to be reduced in short axis to <10 mm. PR was defined as at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum of diameters. The null hypothesis ORR was ≤10% was tested using 1-sided exact test of a single proportion, at 1-sided 0.05 level. ORR was presented with corresponding 2-sided, 95% confidence interval (CI). ORR=CR+PR|From the date of first administration of study treatment until all participants completed a minimum of 6 cycles (28-day cycles) or discontinued treatment prior to the end of Cycle 6 (as of 21 May 2012 data cut-off)|Full Analysis Set (Intent-to-Treat [ITT] Analysis Set) was used and included all participants who received at least 1 dose lenvatinib.||Percentage of participants||95% Confidence Interval|Number
817575|NCT01111526|Secondary|Occurrence of Possibly Related Adverse Events|Number of participants with adverse events possibly related to study treatment, per event category.|5 years, 3 months|All participants||participants|||Number
817576|NCT01111526|Secondary|Stable or Improved Chronic GVHD Severity Score|Stable or improved Chronic GVHD score: Improved Mild to None; Improved Severe to Moderate; Improved Moderate to None, Remained Stable at Mild.|1 year|All participants that received Oral Formulation LBH589 at MTD (5 mg) 3 times per week, for 4 weeks, had overlap syndrome at MTD and were evaluable at 1 year.||participants|||Number
817577|NCT01111526|Secondary|Chronic GVHD Severity at MTD|Chronic GVHD maximum severity grade at MTD, in participants without overlap syndrome at initiation of study therapy. Maximum c-GVHD severity: Mild, Moderate, Severe.|Up to 1 year|All participants that received Oral Formulation LBH589 at MTD (5 mg) 3 times per week, for 4 weeks, had overlap syndrome at MTD and were evaluable at time of analysis.||participants|||Number
817578|NCT01111526|Secondary|Chronic GVHD Onset|Chronic GVHD onset in participants without overlap syndrome at initiation of study therapy. Number of participants with overlap syndrome at MTD.|Up to 1 year|All participants that received Oral Formulation LBH589 at MTD (5 mg) 3 times per week, for 4 weeks.||participants|||Number
817579|NCT01111526|Secondary|Occurrence of Discontinuation of All Immune Suppression|Number of participants discontinuing all immune suppression without subsequent flare by 1 year post initiation of therapy.|1 year|All participants that received Oral Formulation LBH589 at MTD (5 mg) 3 times per week, for 4 weeks and were evaluable at 365 days.||participants|||Number
817580|NCT01111526|Secondary|Overall Survival (OS)|Overall Survival (OS) at one year post initiation of therapy.|1 year|All participants that received Oral Formulation LBH589 at MTD (5 mg) 3 times per week, for 4 weeks.||participants|||Number
817581|NCT01111526|Secondary|Incidence of GVHD Flares Requiring Increasing Immune Suppressive Therapy|Number of participants with GVHD flares requiring increasing immune suppressive therapy within 36 days of study initiation. Cumulative incidence of GVHD flares requiring increasing immune suppressive therapy will be analyzed using the competing risk method by Gray (1988). GVHD flares (progressive disease (PD)) may result in discontinuation from Panobinostat.|Up to 36 days per participant|All participants that received Oral Formulation LBH589 at MTD (5 mg) 3 times per week, for 4 weeks.||participants|||Number
817582|NCT01111526|Primary|Phase II: Overall Rate of Response (ORR)|Rate of Complete Response (CR), Partial Response (PR), Progressive Disease (PD) and Stable Disease (SD). Assessment of GVHD will include the skin, liver and gut. Other possible etiologies of organ disease such as C difficile enterocolitis, viral infection, drug reaction, veno-occlusive disease of the liver, etc., will be excluded by appropriate tests. CR is defined as resolution of GVHD in all evaluable organs with no subsequent additional treatment given for acute GVHD. PR is defined as improvement in ≥ one evaluable organ without deterioration in at least one other. PD is defined as deterioration in at least on evaluable organ. SD is defined as the absence of any difference sufficient to meet minimal criteria for improvement or deterioration in any evaluable organs.|1 year, 2 months|All participants treated at maximum tolerated dose (MTD) of Oral Formulation LBH589, and evaluable at planned time of analysis.||participants|||Number
817586|NCT01111851|Secondary|Brain NK1-receptor Occupancy at the Time of the Maximum Concentration (Tmax)||30 minutes after the end of the 20-minute infusion of fosaprepitant or at 4 hours after oral dosing of aprepitant|"All participants with at least 1 successful postdose PET
scan were included in the analysis population."||Percent of occupancy||95% Confidence Interval|Geometric Mean
839182|NCT01324622|Secondary|Functional Improvement Using the Neck Disability Index (NDI)||up to 24 months|Due to the study’s early termination, no data were collected for this outcome|||||
817595|NCT01112670|Other Pre-specified|Relative Change in Sitagliptin Renal Clearance (CLr)|CLr of sitagliptin when administered with atorvastatin divided by CLr of sitagliptin when administered alone|0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours|The population analyzed included participants who completed both periods of the pharmacokinetic crossover study and who had complete urine data.||ratio||95% Confidence Interval|Mean
817596|NCT01112670|Secondary|Sitagliptin + Atorvastatin: Sitagliptin Renal Clearance (CLr)||0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose|The population analyzed included participants who completed both periods of the pharmacokinetic crossover study and who had complete urine data.||ml/min||Standard Deviation|Mean
817597|NCT01112670|Primary|Sitagliptin Monotherapy: Sitagliptin Renal Clearance (CLr)||0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose|The population analyzed included participants who completed both periods of the pharmacokinetic crossover study and who had complete urine data.||ml/min||Standard Deviation|Mean
817598|NCT01112670|Other Pre-specified|Relative Change in Sitagliptin Maximum Plasma Concentration (Cmax)|Cmax of sitagliptin when administered with atorvastatin divided by Cmax of sitagliptin when administered alone|0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose|The population analyzed included participants who completed both periods of the pharmacokinetic crossover study.||ratio||95% Confidence Interval|Mean
817599|NCT01112670|Other Pre-specified|Relative Change in Sitagliptin Area Under the Plasma Concentration-time Curve (AUC) From 0 to Infinity|AUC of sitagliptin when administered with atorvastatin divided by AUC of sitagliptin when administered alone|0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose|The population analyzed included participants who completed both periods of the pharmacokinetic crossover study.||ratio||95% Confidence Interval|Mean
817600|NCT01112670|Secondary|Sitagliptin + Atorvastatin: Sitagliptin Maximum Plasma Concentration (Cmax)||0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose|The population analyzed included participants who completed both periods of the pharmacokinetic crossover study.||ng/ml||Standard Deviation|Mean
817601|NCT01112670|Secondary|Sitagliptin + Atorvastatin: Sitagliptin Area Under the Plasma Concentration-time Curve (AUC) From 0 to Infinity||0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose|The population analyzed included participants who completed both periods of the pharmacokinetic crossover study.||ng*h/ml||Standard Deviation|Mean
817602|NCT01112670|Primary|Sitagliptin Monotherapy: Sitagliptin Maximum Plasma Concentration (Cmax)||0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose|The population analyzed included participants who completed both periods of the pharmacokinetic crossover study.||ng/ml||Standard Deviation|Mean
817603|NCT01112670|Primary|Sitagliptin Monotherapy: Sitagliptin Area Under the Plasma Concentration-time Curve (AUC) From 0 to Infinity||0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose|The population analyzed included participants who completed both periods of the pharmacokinetic crossover study.||ng*hr/ml||Standard Deviation|Mean
817604|NCT01112683|Secondary|Changes of Safety and Tolerability Assessments at Baseline and End of Study|Clinical history and physical examinations, electrocardiograms (ECGs), comprehensive clinical laboratory tests, and incidence of adverse event recording. The comprehensive clinical laboratory tests will include assessments of liver and kidney function, electrolytes, acid/base balance, and blood glucose and proteins. In addition, pregnancy tests will be performed on all female participants of childbearing potential.|Safety and tolerability assessments will be performed at three time points: 1) 1-7 days before beginning of treatment; 2) after 8 weeks from the beginning of the treatment; and 3) 16-17 weeks from the beginning of the treatment|||participants|||Number
817605|NCT01112683|Secondary|Changes in Benchmark Neuropsychological Measures From Baseline to End of Study|"The neuropsychological benchmark measures assessed in this study are
Peabody Picture Vocabulary Test-III (PPVT-III; range: -27.00 to 23.00)
Test for the Reception of Grammar (TROG; range: -13.00 to 19.00)
Verbal Fluency (from the Developmental Neuropsychological Assessment (NEPSY); range: -13.00 to 10.00)
Recall of Digits (Differential Ability Scales; DAS; -50.00 to 59.00)
Spatial working memory (SWM; part of the Cambridge Neuropsychological Test Automated Battery, or CANTAB; range: -9.00 to 8.00)
Scales of Independent Behavior Revised (SIB-R; -12.00 to 26.00) All listed values represent differences in scores obtained at baseline subtracted from scores at 16-weeks of treatment. With the exception of the spatial working memory, for all measures, higher values represent better outcome. For the spatial working memory, lower values represent better outcome."|Benchmark neuropsychological measures will be assessed one time 24 hours before the beginning of treatment and then a second time 16 weeks from the beginning of the treatment|These measures were not predicted to change due to memantine treatment. Measures of non-verbal reasoning, receptive language and vocabulary, short-term phonological memory, verbal and non-verbal working memory and adaptive/behavioral functioning were included.||scores on a scale||90% Confidence Interval|Mean
817606|NCT01112683|Primary|Changes in Neuropsychological Measures From Baseline to End of Study|"The hippocampus-dependent measures assessed in the present study are
Pattern recognition memory* - Measures visual memory for non-namable designs; scale range in dataset 4-24; higher score indicates better performance
Paired associates task* - Measures ability to learn visual associations between a picture and its location, and retention of this information over time; scale range in dataset 0-17; higher score indicates better performance
California Verbal Learning Test (CVLT) — Children's Version** - Measures episodic verbal memory (sum of the items recalled over the 4 learning trials); scale range in dataset 0-35; higher score indicates better performance
Rivermead Behavioral Memory Test-Children's version** - Measures episodic memory for visual information presented in context; scale range in dataset 1-20; higher score indicates better performance * used in power analysis calculation of sample size ** secondary measures associated with the primary hypothesis"|These neuropsychological measures will be assessed one time 24 hours before the beginning of treatment and then a second time 16 weeks from the beginning of the treatment|One participant dropped out of the study due to parent complaints of increased anxiety, and another was excluded from analyses due to side effects (increased and persistent anxiety) reported at study completion.||units on a scale||90% Confidence Interval|Mean
817607|NCT01112696|Secondary|Device Related Moderate or Device Related Severe Adverse Events|"Device related moderate adverse event: low level of inconvenience or concern to the subject and may interfere with daily activities but is usually improved by simple therapeutic remedy.
Device related severe adverse event: interrupts a subject's daily activity and typically requires intervening treatment.
Note: device related determination is made by the site that there is a reasonable possibility that the adverse event may have been caused by the device."|days one through six of sensor wear||||||
817608|NCT01112696|Primary|Glucose Sensor Accuracy When Compared to Laboratory Standard (YSI): Proportion of Glucose Sensor Readings That Met Accuracy Criteria|The primary accuracy parameter (primary effectiveness endpoint) was the comparative readings of paired sensor and YSI glucose readings, measured on days 1 through 6. Accuracy is defined as within 20% agreement between YSI and paired sensor (within 20 mg/dL if YSI <80 mg/dL). Accuracy ranges from 0 - 100, with higher number suggests better accuracy.|Days one through six of sensor use|98 subjects of 100 enrolled subjects (a total of 5857 paired sensor and YSI readings) completed participation in the inpatient frequent blood sampling procedure.||paired sensor and YSI glucose readings|Participants|95% Confidence Interval|Number
817609|NCT01112865|Secondary|Ease of Use of Each Injection Pen|Participants were asked the following question from Section I of the IPAQ PRO tool, “Thinking about the injection pen you have been using for the past few months, how easy or difficult it is for you to use the injection pen overall?” Responses were provided using a 5 point scale which ranged from very easy (5), somewhat easy (4), neither easy nor difficult (3), somewhat difficult (2), or very difficult (1).|Month 2 and Month 4|FAS; Number of participants analyzed (N) = participants with evaluable data||scores on a scale||Standard Deviation|Mean
817610|NCT01112865|Secondary|Percentage of Dyads and Adult Participants Who Would Choose the New Genotropin Mark VII Injection Pen in Preference to the Genotropin® Pen|"Investigators were asked the following study treatment continuation question, Which device did the participant choose for continued treatment? Choices included the Genotropin® Pen or the new injection pen."|Month 4|FAS subset of participants located in areas where the new device was available.||percentage of dyads, adult participants||95% Confidence Interval|Number
817611|NCT01112865|Secondary|Percentage of Dyads and Adult Participants Reporting the New Genotropin Mark VII Injection Pen Preferable Compared to the Genotropin Pen®|"Participants were asked the following question from Section II of the IPAQ PRO tool, Thinking about both injection pens over the past few months, please choose which injection pen you prefer overall. Choices included: prefer Genotropin Pen®, prefer new injection pen, or no preference."|Month 4|FAS||percentage of dyads, adult participants||95% Confidence Interval|Number
817612|NCT01112865|Secondary|Percentage of Dyads and Adult Participants Reporting the New Genotropin Mark VII Injection Pen Easier to Use Compared to the Genotropin Pen®|"Participants were asked the following question from Section II of the IPAQ PRO tool, Thinking about the Genotropin pen and the new injection pen you used over the past few months, please compare both injection pens and choose which one is easier to use overall? Choices included: Genotropin Pen® easier to use, new injection pen easier to use, or no difference."|Month 4|FAS; Number of participants analyzed (N)= participants with evaluable data||percentage of dyads, adult participants||95% Confidence Interval|Number
817613|NCT01112865|Secondary|Percentage of Dyads and Adult Participants Reporting no Preference or Preference for the New Genotropin Mark VII Injection Pen Compared to the Genotropin Pen®|"Participants were asked the following question from Section II of the IPAQ PRO tool, Thinking about both injection pens over the past few months, please choose which injection pen you prefer overall. Choices included: prefer Genotropin Pen®, prefer new injection pen, or no preference."|Month 4|FAS||percentage of dyads, adult participants||95% Confidence Interval|Number
817614|NCT01112865|Primary|Percentage of Dyads (Participant and Caregiver or Parent) and Adult Participants Reporting no Difference or Easier to Use for the New Genotropin Mark VII Injection Pen Compared to the Genotropin Pen®|"Participants were asked the following question from Section II of the Injection Pen Assessment Questionnaire (IPAQ) patient-reported outcome (PRO) tool, Thinking about the Genotropin pen and the new injection pen you used over the past few months, please compare both injection pens and choose which one is easier to use overall? Choices included: Genotropin Pen® easier to use, new injection pen easier to use, or no difference."|Month 4|Full Analysis Set (FAS): randomized participants who used a study pen at least once to administer somatropin; Number of participants analyzed (N)= participants with evaluable data. Dyad defined as the participant (child being treated) and adult partner (parent or caregiver).||percentage of dyads, adult participants||95% Confidence Interval|Number
817615|NCT01112917|Secondary|Major Device-Related Adverse Events in Converted Subjects||6-months|There was one subject (007-006) excluded as no 6-month images were available although a 6-month assessment was conducted.||participants|||Number
817616|NCT01112917|Primary|Technical Success|Technical success is defined as filter conversion without the loss of filter head components in the vasculature or incomplete opening of filtering legs. Further, in the analysis of the data, the sponsor did not count any filters as a ‘technically’ successful conversion when the operator was unable to snare the filter hook during an attempted conversion.|6-months|||participants|||Number
817617|NCT01113008|Secondary|Cardiovascular Mortality||12 month|||participants|||Number
817618|NCT01113008|Secondary|Readmission Due to Acute Coronary Syndrome||12 month|||participants|||Number
817619|NCT01113008|Primary|Maximum Increase of Troponin at 24 Hours||24 hours|||ng/ml||95% Confidence Interval|Mean
817620|NCT01113385|Secondary|Number of Participants Achieving Complete or Partial Remission at 16 Weeks|Results will be considered clinically significant if the following criteria is met in response to oral galactose therapy at week 16. Complete remission is defined as (Urine Protein:Creatinine ratio [UPC] <0.2 g/g). Partial remission is defined as UPC 0.2-2 g/g.|16 weeks|||participants in remission at 16 weeks|||Number
817621|NCT01113385|Primary|Focal Segmental Glomerulosclerosis Permeability Factor (FSPF)|FSPF is reported in relation to its induction of glomerular albumin permeability (Palb) of isolated glomeruli on a range from 0 to 1, with 0 indicative of normal glomeruli and 1 indicative of injury to the permeability barrier. Results will be considered clinically significant if the following criteria is met in response to oral galactose therapy at week 16: Reduction in FSPF to <0.5 Palb or decrease in FSPF by > 0.3 Palb.|16 weeks|||Palb||Standard Deviation|Mean
817622|NCT01113398|Secondary|Percentage of Participants Who Experience Treatment-related Grade 2 or Greater CNS Hemorrhage or Grade 4 or Greater Non-hematologic Toxicities|The percentage of participants who experience unacceptable toxicity, defined as any treatment-related grade 2 or greater CNS hemorrhage or grade 4 or greater non-hematologic toxicity, will be calculated.|2 years|Intent-to-treat||percentage of participants|||Number
818242|NCT01118117|Secondary|Device Related Peri-Procedural Complications|Peri-procedural (prior to discharge) measure of success (i.e., patency and none of the following: death, stroke, MI, embolization, thrombosis, and occlusion)|Prior to Hosptial Discharge|All enrolled participants evaluated prior to hospital discharge||percentage of subjects with event|||Number
817623|NCT01113398|Secondary|Six-month Progression-free Survival (PFS6)|The percentage of participants alive and progression-free at 6 months after the start of study treatment will be determined. PFS6 will be calculated from the date study treatment started until the date of progression or death, or the date of last follow-up if participants are alive without progression. Kaplan-Meier methods will be used to estimate survival.|6 months|Intent-to-treat||percentage of participants||95% Confidence Interval|Number
817624|NCT01113398|Secondary|Median Overall Survival (OS)|Overall survival is defined as the time in months from the start of protocol treatment until the date of death, or the date of last follow-up if alive. Kaplan-Meier methods will be used to estimate overall survival.|2 years|Intent-to-treat||Months||95% Confidence Interval|Median
817625|NCT01113398|Primary|Radiographic Response|The percentage of participants with a complete or partial response as determined by modified Response Assessment in Neuro-Oncology (RANO) criteria will be determined. Complete Response (CR) is defined as complete disappearance on MR/CT of all enhancing tumor and mass effect, off all corticosteroids (or receiving only adrenal replacement doses) and accompanied by a stable or improving neurologic examination. Partial Response (PR) is defined as greater than or equal to 50% reduction in tumor size on MR/CT by bi-dimensional measurement, on a stable or decreasing dose of corticosteroids and accompanied by a stable or improving neurologic examination. Tumor assessments are done at baseline and the end of every 6-week cycle thereafter.|2 years|Intent-to-treat||percentage of participants||95% Confidence Interval|Number
817626|NCT01113463|Secondary|Number of Participants by Response Criteria|Complete Response (CR): Complete disappearance all measurable & evaluable disease. No new lesions or evidence of non-evaluable disease. Partial Response (PR): >/= 50% decrease under baseline in sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease, nor new lesions. Stable/No Response: Does not qualify for CR, PR, or progression. The designation of Stable/No Response requires a minimum of 12 weeks duration. Progression: 25% increase in sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer). Unknown: Progression not been documented & one or more measurable or evaluable sites have not been assessed.|Response obtained between days 15 and 21 of every even cycle and/or when clinically indicated, up to 6 months (approximately 9 completed cycles)|Intent to treat population included all eligible subjects who received at least one dose of study drug.||participants|||Number
817627|NCT01113463|Primary|Progression-Free Survival (PFS) at 6 Months|"PFS defined as number of participants alive without documented evidence of disease progression (progression free) at 6 months. Progression-free survival calculated from the date of Day 1 Cycle 1 to the date that criteria for progression of disease is first seen. Progression is defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer)."|6 months (following nine 21-day cycles)|Intent to treat population included all eligible subjects who received at least one dose of study drug.||participants|||Number
817628|NCT01113541|Secondary|Number of Participants With Suicidal Tendencies (Columbian-Suicide Severity Rating Scale, [C-SSRS], Mapped to C-CASA [Columbia Classification Algorithm For Suicide Assessment])|C-SSRS is a participant rated questionnaire to assess suicidal ideation, suicidal behavior, actual attempts (yes or no responses), and intensity of ideation (rated 1=low severity to 5=high severity). Yes/No responses are mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) categories: Completed suicide, suicide attempt, preparatory acts toward imminent suicidal behavior, suicidal ideation, and self-injurious behavior, or no suicidal intent. A participant could have a yes or no response in more than one category.|Baseline, Week 1 through Week 52 or Early Termination|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.||participants|||Number
817629|NCT01113541|Secondary|Change From Baseline in Impact of Weight on Quality of Life-Lite Version (IWQOL-Lite) Scale|31-item self report inventory to assess impact of weight on quality of life. Five subscales: physical functioning, self-esteem, sexual life, public distress, and work, with categories in each subscale scored 1 (no trouble or difficulty) to 5 (persistent trouble or difficulty). The rescaled IWQoL-Lite score is determined by the sum of scores on all 31 items and rescaling this sum to a 1 to 100 scoring with 0=the poorest and 100=the best quality of life.|Baseline, Week 28, Week 52 or Early Termination|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.||scores on a scale||Standard Deviation|Mean
817630|NCT01113541|Secondary|Change From Baseline in European Quality of Life (EuroQol) Visual Analogue Scale (EQ-5D VAS): Current Health State Score|EQ-5D: subject rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.|Baseline, Week 28, Week 52 or Early Termination|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.||scores on scale||95% Confidence Interval|Mean
817631|NCT01113541|Secondary|Change From Baseline in EuroQoL Index (EQ-I)|EQ-5D: subject rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Week 28, Week 52 or Early Termination|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.||scores on scale||95% Confidence Interval|Mean
817660|NCT01113580|Primary|The Percentage of Evaluable Participants Achieving a HI Titre ≥ 40 or Single Radial Haemolysis (SRH) Area ≥ 25 mm2.||Approximately 21 days after vaccination|The Evaluable Population comprised all participants who were vaccinated with the study vaccine, provided both pre- and post-vaccination antibody titre results, and were not excluded from the analyses (eg, for the use of a prohibited medication or a laboratory-confirmed influenza virus infection between Visits 1 and 2).||Percentage of participants||95% Confidence Interval|Number
817632|NCT01113541|Secondary|Change From Baseline in Social and Occupational Functioning Assessment Scale (SOFAS)|0-100 single score scale focusing exclusively on participant's level of social and occupational functioning; not directly influenced by overall severity of participant's psychological symptoms; higher score = higher level of functioning. 1 to 10 = persistent inability to maintain minimal personal hygiene; unable to function without harming self or others or without considerable external support; 91 to 100 = superior functioning in a wide range of activities.|Baseline, Week 28, Week 52 or Early Termination|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.||scores on scale||Standard Deviation|Mean
817633|NCT01113541|Secondary|Change From Baseline in Drug Attitude Inventory (DAI)|DAI, a 10-item scale to assess how the attitude of schizophrenia participants toward their medications may affect compliance. Respondents indicate 'true' or 'false' for each item. An overall calculated score ranged from -10 to 10, where a positive score indicated a positive subjective response (compliant), a negative score indicated non-compliance. Change: score at observation minus score at baseline.|Week 28, Week 52 or Early Termination|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.||scores on a scale||Standard Deviation|Mean
817634|NCT01113541|Secondary|Clinical Global Impression - Improvement (CGI-I) Subscale Score|CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Week 52 or Early Termination|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.||scores on a scale||Standard Deviation|Mean
817635|NCT01113541|Secondary|Change From Baseline in Clinical Global Impression - Severity (CGI-S) Subscale|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected.|Baseline, Week 4, Week 12, Week 28, Week 52 or Early Termination|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.||scores on a scale||Standard Deviation|Mean
817636|NCT01113541|Secondary|Change From Baseline in Young Mania Rating Scale (YMRS)|11-item scale that measures the severity of manic episodes from subject reported symptoms over previous 48 hours and clinical observation during interview. Four items (irritability, speech, thought content, disruptive-aggressive behaviour) are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining 7 items (elevated mood, increased motor activity-energy, sexual interest, sleep, language-thought disorder, appearance, insight) are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). YMRS total score range = 0 to 60.|Baseline, Week 4, Week 12, Week 28, Week 52 or Early Termination|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.||scores on a scale|||Number
817637|NCT01113541|Secondary|Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score|Measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline, Week 4, Week 12, Week 28, Week 52 or Early Termination|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.||scores on a scale||Standard Deviation|Mean
817638|NCT01113541|Secondary|Change From Baseline in Physical Activity Index|Physical activity (exercise) score derived for each participant based on the frequency and intensity of physical activities: regular walking, recreational activity, cycling, and sporting activity. Six categories of total score: inactive (range: 0-2), occasional (range: 3-5), light (range: 6-8), moderate (range: 9-12), moderately vigorous (range: 13-20), and vigorous (≥21). Higher score = higher frequency and intensity of physical activity.|Baseline, Week 28, Week 52 or Early Termination|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.||units on a scale|||Number
817639|NCT01113541|Secondary|Change From Baseline in Leptin||Baseline, Week 52 or Early Termination|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.||nanograms per milliliter||Standard Deviation|Mean
817640|NCT01113541|Secondary|Change From Baseline in Apolipoprotein B (ApoB) Levels||Baseline, Week 52 or Early Termination|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.||milligrams per deciliter||Standard Deviation|Mean
817641|NCT01113541|Secondary|Change From Baseline in Corrected QT Interval (QTc): Fridericia's Heart Rate Correction Formula (QTcF)|QT interval is the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTc is the QT interval corrected for heart rate. Corrected QT interval using Fridericia's heart rate correction formula: QTcF = QT/RR^1/3, where RR=RR interval in seconds.|Baseline, Week 4, Week 52 or Early Termination|PP and ITT; n = number of participants with analyzable data at observation.||milliseconds||Standard Deviation|Mean
817642|NCT01113541|Secondary|Change From Baseline in Insulin Levels||Baseline, Week 52 or Early Termination|PP and ITT. Insulin levels not reported: data not summarized due to limited enrollment and early termination of the study.||international units per milliliter||Full Range|Median
817643|NCT01113541|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)||Baseline, Week 52 or Early Termination|PP and ITT. Median was reported due to small sample size and risk of skewing. Last observation = last observation while on study drug or during the lag.||percent HbA1c||Full Range|Median
817644|NCT01113541|Secondary|Change From Baseline in Body Mass Index (BMI)|Body mass index = weight in kilograms (kg) / height in meters (m)^2 .|Baseline, Week 4, Week 12, Week 52 or Early Termination|PP and ITT. Results for BMI not reported: data not summarized due to limited enrollment and early termination of the study.||kg/m^2||Standard Deviation|Mean
817645|NCT01113541|Secondary|Change From Baseline in Weight||Baseline, Week 4, Week 12, Week 52 or Early Termination|PP and ITT; n = number of participants with evaluable data at observation.||kilograms||Standard Deviation|Mean
817646|NCT01113541|Secondary|Change From Baseline in Total Cholesterol and Low-density Lipoprotein (LDL) Cholesterol Levels||Baseline, Week 52 or Early Termination|PP and ITT. Median was reported due to small sample size and risk of skewing.||milligrams per deciliter||Full Range|Median
818258|NCT01118273|Secondary|Global Assessment of Study Medication as a Pain Reliever|Subject responded to question, 'How would you rating this study medication you received as a pain-reliever?' with the following choices: Poor (0), Fair(1), Good(2), Very Good(3), Excellent(4)|Up to 10 hours|ITT (Intent to Treat) Population||Participants|||Number
817647|NCT01113541|Secondary|Change From Baseline in Ten-year Coronary Heart Disease (CHD) Risk According to Framingham Scoring System|Framingham scoring system risk factors: age (risk points range: -9 to 16), cholesterol (risk points range: 0 to 13), HDL cholesterol (risk points range: -1 to 2), smoking (risk points range: 0 to 9), and systolic blood pressure (risk points range: 0 to 6); total risk points range <0 to ≥25, higher score indicates higher 10 year risk (range <1% to ≥30% 10 year risk).|Baseline, Week 4, Week 52|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.||scores on a scale||Standard Deviation|Mean
817648|NCT01113541|Secondary|Change From Baseline in Individual Risk Factors of Metabolic Syndrome (MS): Elevated Triglycerides|MS risk factor elevated triglycerides defined as ≥1.7 millimoles per liter (mmol/L) (1≥50 mg/dL).|Baseline, Week 4, Week 12, Week 52|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.||millimoles per liter||Standard Deviation|Mean
817649|NCT01113541|Secondary|Change From Baseline in Individual Risk Factors of Metabolic Syndrome (MS): Reduced High-density Lipoprotein Cholesterol (HDL-C)|MS risk factor reduced HDL-C defined as <1.03 millimoles per liter (mmol/L) (<40 mg/dL) in men and <1.3 mmol/L (<50 mg/dL) in women.|Baseline, Week 4, Week 12, Week 52|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.||millimoles per liter||Standard Deviation|Mean
817650|NCT01113541|Secondary|Change From Baseline in Individual Risk Factors of Metabolic Syndrome (MS): Elevated Fasting Glucose|MS risk factor elevated fasting glucose defined as ≥5.6 millimoles per liter (mmol/L) (≥100 mg/dL).|Baseline, Week 4, Week 12, Week 52|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.||millimoles per liter||Standard Deviation|Mean
817651|NCT01113541|Secondary|Change From Baseline in Individual Risk Factors of Metabolic Syndrome (MS): Elevated Systolic/Diastolic Blood Pressure|MS risk factor elevated systolic/diastolic blood pressure defined as systolic blood pressure ≥130 millimeters of mercury (mm Hg) and/or diastolic blood pressure ≥85 mm Hg.|Baseline, Week 4, Week 12, Week 52|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.||millimeters of mercury||Standard Deviation|Mean
817652|NCT01113541|Secondary|Change From Baseline in Individual Risk Factors of Metabolic Syndrome (MS): Elevated Waist Circumference|MS risk factor elevated waist circumference defined as ≥102 centimeters (cm) in men and ≥88 cm in women (Asian origin: ≥90 cm [men] and ≥80 cm [women]).|Baseline, Week 4, Week 12, Week 52|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.||centimeters||Standard Deviation|Mean
817653|NCT01113541|Secondary|Percentage of Participants With Individual Metabolic Syndrome (MS) Risk Factors|MS risks factors = elevated waist circumference: ≥102 cm in men and ≥88 cm in women (Asian origin: ≥90 cm [men] and ≥80 cm [women]); elevated triglycerides: ≥1.7 mmol/L (1≥50 mg/dL); reduced HDL-C: <1.03 mmol/L (<40 mg/dL) in men and <1.3 mmol/L (<50 mg/dL) in women; elevated fasting glucose: ≥5.6 mmol/L (≥100 mg/dL); and elevated systolic/diastolic blood pressure: systolic blood pressure ≥130 mm Hg and/or diastolic blood pressure ≥85 mm Hg.|Baseline through Week 52|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.||percentage of participants|||Number
817654|NCT01113541|Secondary|Change From Baseline in the Percentage of Participants With Each Individual Metabolic Syndrome (MS) Risk Factor|MS risks factors: elevated waist circumference: ≥102 cm in men and ≥88 cm in women (Asian origin: ≥90 cm [men] and ≥80 cm [women]); elevated triglycerides: ≥1.7 mmol/L (1≥50 mg/dL); reduced HDL-C: <1.03 mmol/L (<40 mg/dL) in men and <1.3 mmol/L (<50 mg/dL) in women; elevated fasting glucose: ≥5.6 mmol/L (≥100 mg/dL); and elevated systolic/diastolic blood pressure: systolic blood pressure ≥130 mm Hg and/or diastolic blood pressure ≥85 mm Hg.|Baseline through Week 52|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.||percentage of participants|||Number
817655|NCT01113541|Secondary|Metabolic Syndrome (MS) Prevalence|Percentage of participants at each visit defined as having metabolic syndrome (MS) based on the National Cholesterol Education Program (NCEP) Adult Treatment Panel III. MS = 3 or more of 5 characteristics: abdominal obesity, hypertriglyceridemia, low high-density lipoprotein (HDL) cholesterol, high blood pressure, and high fasting glucose.|Baseline through Week 52|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.||percentage of participants|||Number
817656|NCT01113541|Secondary|Mean Change From Baseline in the Number of Risk Factors of Metabolic Syndrome (MS)|MS risks factors: elevated waist circumference: ≥102 cm in men and ≥88 cm in women (Asian origin: ≥90 cm [men] and ≥80 cm [women]); elevated triglycerides: ≥1.7 mmol/L (1≥50 mg/dL); reduced HDL-C: <1.03 mmol/L (<40 mg/dL) in men and <1.3 mmol/L (<50 mg/dL) in women; elevated fasting glucose: ≥5.6 mmol/L (≥100 mg/dL); and elevated systolic/diastolic blood pressure: systolic blood pressure ≥130 mm Hg and/or diastolic blood pressure ≥85 mm Hg.|Baseline, Week 52|PP and Intent-to-treat (ITT) population; ITT population = all participants enrolled in the study who received at least 1 dose of study medication and who had baseline and at least 1 post-baseline MS measurement. Results not reported: data not summarized due to limited enrollment and early termination of the study.||risk factors||Standard Deviation|Mean
817657|NCT01113541|Primary|Percentage of Participants Who Achieved a Reduction From Baseline of at Least 1 Risk Factor for Metabolic Syndrome (MS) at Week 52 or Premature Discontinuation|MS risks factors: elevated (el) waist circumference: ≥102 centimeters (cm) in men and ≥88 cm in women (Asian origin: ≥90 cm [men] and ≥80 cm [women]); el triglycerides: ≥1.7 millimoles per liter (mmol/L) (1≥50 milligrams per deciliter [mg/dL]); reduced high-density lipoprotein cholesterol (HDL-C): <1.03 mmol/L (<40 mg/dL) in men and <1.3 mmol/L (<50 mg/dL) in women; el fasting glucose: ≥5.6 mmol/L (≥100 mg/dL); and el systolic/diastolic blood pressure: systolic ≥130 millimeters of mercury (mmHg) and/or diastolic ≥85 mmHg. Responder = at least 1 less risk factor at endpoint than baseline.|Week 52 or Early Termination|Per protocol population: all subjects in the intent-to-treat population who remained in the study for at least 28 weeks. N = number of participants with analyzable data at observation.||percentage of participants|||Number
817658|NCT01113580|Secondary|Frequency and Intensity of Any Unsolicited Adverse Events|"Unsolicited adverse event (UAE) grading:
Mild: Symptoms were easily tolerated and there was no interference with daily activities. Moderate: Enough discomfort to have caused some interference with daily activities. Severe: Symptoms that prevented normal, everyday activities."|After vaccination until the end of the study; approximately 21 days|The Safety Population comprised all participants who received study vaccine and provided follow-up safety data.||participants|||Number
817661|NCT01113580|Primary|The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination.|GMFI is defined as the geometric mean of the fold increases of post-vaccination antibody titre over the pre-vaccination antibody titre.|Approximately 21 days after vaccination|The Evaluable Population comprised all participants who were vaccinated with the study vaccine, provided both pre- and post-vaccination antibody titre results, and were not excluded from the analyses (eg, for the use of a prohibited medication or a laboratory-confirmed influenza virus infection between Visits 1 and 2).||Fold increase||95% Confidence Interval|Number
817662|NCT01113580|Primary|The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre.|As per the criteria specified in the CPMP/BWP/214/96 Note for Guidance on Harmonisation of Requirements for Influenza Vaccines. For haemagglutination inhibition (HI), seroconversion is defined as achieving a post-vaccination titre of ≥ 40 for those participants with a pre-vaccination HI titre of < 10; significant increase is defined as a four-fold or greater increase in HI titre for those participants with a pre-vaccination HI titre of ≥ 10.|Approximately 21 days after vaccination|The Evaluable Population comprised all participants who were vaccinated with the study vaccine, provided both pre- and post-vaccination antibody titre results, and were not excluded from the analyses (eg, for the use of a prohibited medication or a laboratory-confirmed influenza virus infection between Visits 1 and 2).||Percentage of participants||95% Confidence Interval|Number
817663|NCT01113632|Secondary|Safety of the Treatment Regimen|Listing of all non-serious Adverse Events ocurring in 5% of patients or more|18 Months|||participants|||Number
817664|NCT01113632|Secondary|Number of Partial Responses|The Number of Patients Who Experience a Partial Response From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions|18 Months|All patients who were evaluable for a response assessment||participants|||Number
817665|NCT01113632|Secondary|Number of Complete Responses|The Number of Patients Who Experience a Complete Response From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions|18 Months|All patients who were evaluable for a response assessment||participants|||Number
817666|NCT01113632|Primary|Overall Response Rate (ORR)|The Number of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|18 months|All patients who were evaluable for a response assessment||participants|||Number
817667|NCT01113632|Secondary|Progression-free Survival (PFS)|To assess the overall response rate of patients with previously untreated CLL or SLL receiving ofatumumab.|18 months|||months||95% Confidence Interval|Median
817668|NCT01113710|Secondary|Daytime Tiredness|"Daytime tiredness measured as change from baseline to end of observation period (Item 6 RLS-6 scale).
The Last Observation Carried Forward (LOCF) method was utilized for all outcomes.
The RLS-6 scale is an 11-point scale (from 0 = not present/completely satisfied to 10 = very severe/completely dissatisfied) to establish an individual severity profile at various day and night times (at bedtime; during the night; during the day when the patients are resting, or during the day when the patients are involved in daily activities)."|From Baseline to end of Observation Period (3 months).|"Of the 564 subjects in the Full Analysis Set (FAS), 561 are included in this analysis.
The FAS consists of all patients receiving treatment with Rotigotine at least once & for whom valid scores for item 2 & item 3 of the RLS-6 scale at baseline & at least one valid post baseline score for both item 2 & item 3 of the RLS-6 scale is documented."||units on a scale||Standard Deviation|Mean
817669|NCT01113710|Secondary|Severity of Restless Legs Syndrome (RLS) at Daytime in Activity|"Severity of RLS at daytime in activity measured as change from baseline to end of observation period (Item 5 RLS-6 scale).
The Last Observation Carried Forward (LOCF) method was utilized for all outcomes.
The RLS-6 scale is an 11-point scale (from 0 = not present/completely satisfied to 10 = very severe/completely dissatisfied) to establish an individual severity profile at various day and night times (at bedtime; during the night; during the day when the patients are resting, or during the day when the patients are involved in daily activities)."|From Baseline to end of Observation Period (3 months).|"Of the 564 subjects in the Full Analysis Set (FAS), 564 are included in this analysis.
The FAS consists of all patients receiving treatment with Rotigotine at least once & for whom valid scores for item 2 & item 3 of the RLS-6 scale at baseline & at least one valid post baseline score for both item 2 & item 3 of the RLS-6 scale is documented."||units on a scale||Standard Deviation|Mean
817670|NCT01113710|Secondary|Severity of Restless Legs Syndrome (RLS) at Daytime at Rest|"Severity of RLS at daytime at rest measured as change from baseline to end of observation period (Item 4 RLS-6 scale).
The Last Observation Carried Forward (LOCF) method was utilized for all outcomes.
The RLS-6 scale is an 11-point scale (from 0 = not present/completely satisfied to 10 = very severe/completely dissatisfied) to establish an individual severity profile at various day and night times (at bedtime; during the night; during the day when the patients are resting, or during the day when the patients are involved in daily activities)."|From Baseline to end of Observation Period (3 months).|"Of the 564 subjects in the Full Analysis Set (FAS), 562 are included in this analysis.
The FAS consists of all patients receiving treatment with Rotigotine at least once & for whom valid scores for item 2 & item 3 of the RLS-6 scale at baseline & at least one valid post baseline score for both item 2 & item 3 of the RLS-6 scale is documented."||units on a scale||Standard Deviation|Mean
817671|NCT01113710|Secondary|Satisfaction With Sleep|"Satisfaction with sleep measured as change from baseline to end of observation period (Item 1 RLS-6 scale).
The Last Observation Carried Forward (LOCF) method was utilized for all outcomes.
The RLS-6 scale is an 11-point scale (from 0 = not present/completely satisfied to 10 = very severe/completely dissatisfied) to establish an individual severity profile at various day and night times (at bedtime; during the night; during the day when the patients are resting, or during the day when the patients are involved in daily activities)."|From Baseline to end of Observation Period (3 months).|"Of the 564 subjects in the Full Analysis Set (FAS), 564 are included in this analysis.
The FAS consists of all patients receiving treatment with Rotigotine at least once & for whom valid scores for item 2 & item 3 of the RLS-6 scale at baseline & at least one valid post baseline score for both item 2 & item 3 of the RLS-6 scale is documented."||units on a scale||Standard Deviation|Mean
817672|NCT01113710|Primary|Severity of Restless Legs Syndrome (RLS) During the Night|"Severity of RLS during the night measured as change from baseline to end of observation period (Item 3 RLS-6 scale).
The Last Observation Carried Forward (LOCF) method was utilized for all outcomes.
The RLS-6 scale is an 11-point scale (from 0 = not present/completely satisfied to 10 = very severe/completely dissatisfied) to establish an individual severity profile at various day and night times (at bedtime; during the night; during the day when the patients are resting, or during the day when the patients are involved in daily activities)."|From Baseline to end of Observation Period (3 months).|"Of the 564 subjects in the Full Analysis Set (FAS), 564 are included in this analysis.
The FAS consists of all patients receiving treatment with Rotigotine at least once & for whom valid scores for item 2 & item 3 of the RLS-6 scale at baseline & at least one valid post baseline score for both item 2 & item 3 of the RLS-6 scale is documented."||units on a scale||Standard Deviation|Mean
817673|NCT01113710|Primary|Severity of Restless Legs Syndrome (RLS) at Bedtime|"Severity of RLS at bedtime measured as change from baseline to end of observation period (Item 2 RLS-6 scale).
The Last Observation Carried Forward (LOCF) method was utilized for all outcomes.
The RLS-6 scale is an 11-point scale (from 0 = not present/completely satisfied to 10 = very severe/completely dissatisfied) to establish an individual severity profile at various day and night times (at bedtime; during the night; during the day when the patients are resting, or during the day when the patients are involved in daily activities)."|From Baseline to end of Observation Period (3 months).|"Of the 564 subjects in the Full Analysis Set (FAS), 564 are included in this analysis.
The FAS consists of all patients receiving treatment with Rotigotine at least once & for whom valid scores for item 2 & item 3 of the RLS-6 scale at baseline & at least one valid post baseline score for both item 2 & item 3 of the RLS-6 scale is documented."||units on a scale||Standard Deviation|Mean
817674|NCT01113723|Primary|Time to Confirm the Placement of the Tracheal Tube|It is the time (in seconds) following initial insertion of laryngoscope blade to confirm with CO2 waveform|up tp 3 minutes|||Seconds||Standard Deviation|Mean
817675|NCT01113723|Primary|Intubation Time (Seconds)|Times (seconds) following initial insertion of laryngoscope blade to placement of tracheal tube|3 minutes|||Seconds||Standard Deviation|Mean
817676|NCT01113723|Secondary|Time to Obtain Glottis Visualization (Seconds)|Time to Obtain Glottis Visualization (Seconds): View of the glottis during the beginning of the intubation procedure. (approximately 1 minute) Glottic (the opening between the vocal cords at the upper part of the larynx) visualization comparison between the two devices in patients with an unstable cervical spine.|1 minute|Time to Obtain Glottis Visualization (Seconds) Glottic visualization during the beginning of the intubation procedure.||Seconds||Standard Deviation|Mean
817677|NCT01113749|Post-Hoc|Percentage of Subjects With Weight Loss|Percentage of subjects with weight loss at 9 months|9 months|intention to treat||percentage of participants|||Number
817678|NCT01113749|Secondary|Percent With Treatment Decisions|Treatment decisions are expressed as percentage of subjects with discussions of new tube feeding, new orders to forego tube feeding, and new choices for assisted feeding.|3 months|||percentage of subjects|||Number
817679|NCT01113749|Primary|Decisional Conflict Scale|Decisional Conflict Scale measures conflict in decisions Total scale range 1-5 with lower scores indicating less conflict.|3 months|intention to treat||units on a scale||95% Confidence Interval|Mean
817680|NCT01113931|Secondary|Microbiological Cure C. Trachomatis, N. Gonorrhoea Negative Population, Day 28, Percentage Participants Cured|Percentage Participants cured in N. gonorrhoea Negative Population: cured defined as both microbiological cure (negative result for urogenital C. trachomatis, determined by GP AC2 NAAT/Gen-Probe Aptima Combo 2 Nucleic Acid Amplification test) and clinical cure (males defined as resolution of baseline signs/symptoms of dysuria, urethral pruritis and urethral discharge, and resolution of exam finding of urethral discharge; females - resolution of exam finding of endocervical discharge) at Day 28|Day 28|N. gonorrhoea Population. Only subjects with an evaluable outcome are included in the analysis.||Percentage Participants Cured||95% Confidence Interval|Number
817681|NCT01113931|Secondary|Microbiological Cure C. Trachomatis and M. Genitalium, M. Genitalium Coinfected Population, Day 28, Percentage Participants Cured|Percentage Subjects Cured of both M. genitalium and C. trachomatis M. genitalium co-infected population: microbiological cure for both at Day 28, defined as negative PCR (polymerase chain reaction) for M. genitalium and negative GP AC2 NAAT (Gen-Probe Aptima Combo 2 Nucleic Acid Amplification test) for C. trachomatis at Day 28|End of Study (Day 28)|M. genitalium Coinfected Population||Percentage Participants Cured|||Number
817682|NCT01113931|Secondary|Microbiological Cure and Clinical Cure of C. Trachomatis, Day 28, Clinically Evaluable Population, Percentage Participants Cured|Microbiological cure (defined as a negative result for urogenital C. trachomatis, determined by GP AC2 NAAT/Gen-Probe Aptima Combo 2 Nucleic Acid Amplification Test and clinical cure (for males defined as resolution of baseline signs/symptoms of dysuria, urethral pruritus and urethral discharge, and resolution of exam finding of urethral discharge; for females resolution of exam finding of endocervical discharge) at Day 28|End of Study (Day 28)|Clinically Evaluable Population||Percentage Particpants Cured|||Number
817683|NCT01113931|Primary|Microbiological Cure Rate|Percentage of Subjects in mITT Population with Microbiological Cure defined as a negative result for C. trachomatis as determined by GP AC2 NAAT (Gen-Probe Aptima Combo 2 Nucleic Acid Amplification Test) at Day 28|Day 28|mITT Population - all randomized subjects who had positive NAAT for C. trachomatis at Baseline and took at least one dose of study drug.||percentage of participants cured||95% Confidence Interval|Number
817684|NCT01114334|Secondary|Patient Health Questionnaire-9 Instrument for Assessing Depressive Symptoms|"Depressive symptoms were measured with the Patient Health Questionnaire-9 (PHQ-9) instrument. The PHQ-9 is a nine item survey to assess depressive symptoms over the previous 2 weeks. The patient may answer not at all (scored as a 0) , several days (scored as a 1), more than half the days (scored as a 2), or nearly every day (scored as a 3) for each item. The range in total scores is from 0 (no depressive symptoms or best outcome) to 27 (severe depressive symptoms or worst outcome). For this randomized trial mean total scores are reported."|36 weeks|||units on a scale||95% Confidence Interval|Mean
817699|NCT01114360|Secondary|Mean Daytime Systolic Blood Pressure (SBP)|The daytime systolic blood pressure was calculated as the average systolic blood pressure during daytime period based on 24hour ambulatory blood pressure monitoring. Means of multiple measurements were reported|At the end of 4 weeks|37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls.||mmHg||Standard Error|Mean
817685|NCT01114334|Secondary|Adherence to Treatment With Antidepressant Medication|"Antidepressant Adherence will be measured with Computerized Pharmacy Records. Adherence will be operationalized as non-persistence, or time to discontinuation. Non-persistence will be considered to have occurred if the days of medication supply from the previous prescription plus a 30-day grace period exceed the number of days between the previous prescription date and the current prescription fill date. Filling no prescriptions, 'initiation failure,' will be treated as non-persistence. Minimally adequate persistence was defined as at least three 30-day fills of an antidepressant medication at a usual dose as defined in the American Psychiatric Association guideline without a 30-day gap in refills. The count of participants receiving minimally adequate persistence with antidepressant medication is reported for each study group."|36 weeks|||Participants|||Count of Participants
817686|NCT01114334|Primary|Depression Remission|The primary outcome is depression remission ascertained with the Patient Health Questionnaire-9. A score of less than 5 is considered to represent remission. The secondary clinical outcome is the continuous measure of depressive symptoms.|36 weeks|We present clinical outcome (remission rate) at 36 weeks for all patient participants entering the study. 58 of 80 subjects assigned to Guideline-Based Medical Management, and 67 of 88 subjects assigned to Motivational Interview with Guideline-Based Medical Management had available data at 36 weeks (end of trial).||participants|||Number
817687|NCT01114360|Secondary|Percentage of Participants With Melatonin-related Side Effect.||After 4 weeks of treatment|37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls.||percentage of total number of patients|||Number
817688|NCT01114360|Secondary|Nocturnal Dipping of Blood Pressure|Nocturnal dipping is the mean nighttime to mean daytime systolic and diastolic blood pressure ratios, or the percentage drop in nocturnal SBP compared to day time SBP. Night was defined as 10:00 PM through 5:59 AM. This ratio is calculated by the ambulatory blood pressure readings.|At the end of 4 weeks|||percentage ratio in night/day SBP||Standard Error|Mean
817689|NCT01114360|Secondary|Total Sleep Time|The total sleep time will be measured by polysomnography (PSG) using an Embla polysomnograph. The nocturnal total sleep time (TST) or the the total number of minutes in any stage of sleep during the major nocturnal sleep period was measured by PSG.|At the end of 4 weeks|37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls.||minutes||Standard Error|Mean
817690|NCT01114360|Secondary|Plasma P-Selectin|P-Selectin is a marker of endothelial function. Levels of p-selectin were measured from stored plasma using enzyme-linked immunosorbent assay (ELISA).|At the end of 4 weeks|37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls.||ng/ml||Standard Error|Mean
817691|NCT01114360|Secondary|Plasma E-Selectin|E-Selectin is a marker of endothelial function. Levels of e-selectin were measured from stored plasma using enzyme-linked immunosorbent assay (ELISA).|At the end of 4 weeks|37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls.||ng/ml||Standard Error|Mean
817692|NCT01114360|Secondary|Urinary Adrenaline Excretion Rate|The rate of urinary adrenaline excretion was measured by the Enzyme-Linked Immunosorbent Assay (ELISA) method from urine samples collected overnight.|At the end of 4 weeks|40 patients were enrolled in the study. 4 subjects did not complete the study. 36 patients completed the study and were their own controls.||ng/ml/min||Standard Error|Mean
817693|NCT01114360|Secondary|Urinary Noradrenaline Excretion Rate|The rate of urinary noradrenaline excretion was measured by the Enzyme-Linked Immunosorbent Assay (ELISA) method from urine samples collected overnight.|At the end of 4 weeks|37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls.||ng/ml/min||Standard Error|Mean
817694|NCT01114360|Secondary|Urinary Dopamine Excretion Rate|The rate of urinary dopamine excretion was measured by the Enzyme-Linked Immunosorbent Assay (ELISA) method from urine samples collected overnight.|At the end of 4 weeks|37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls.||ng/ml/min||Standard Error|Mean
817695|NCT01114360|Primary|Mean Nighttime Diastolic Blood Pressure (DBP)|The nighttime diastolic blood pressure (DBP) was recorded using an ambulatory blood pressure (ABP) monitor. The measurements occurring from the onset of self-reported sleep to the end of self-reported sleep were recorded. Means of multiple measurements were reported|At the end of 4 weeks|37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls.||mmHg||Standard Error|Mean
817696|NCT01114360|Secondary|Mean Daytime Heart Rate (HR)|Daytime heart rate is the number of the pulsations of the heart per unit of time during the day. It is measured in beats per minute (bpm). Ambulatory blood pressure monitoring was used to calculate the heart rate. Means of multiple measurements were reported|At the end of 4 weeks|37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls.||beats per minute||Standard Error|Mean
817697|NCT01114360|Secondary|Mean Daytime Mean Arterial Pressure (MAP)|Daytime mean arterial pressure (MAP) is the average blood pressure in the subject's arteries during one cardiac cycle (one complete heartbeat) during the day. It is calculated using the formula, MAP = 1/3(SBP-DBP)+DBP; where SBP is the systolic blood pressure and DBP is the diastolic blood pressure. Means of multiple measurements were reported.|At the end of 4 weeks|40 subjects enrolled the study. 4 subjects did not complete the study. 36 subjects completed the study in a crossover design, being their own controls.||mmHg||Standard Error|Mean
817698|NCT01114360|Secondary|Mean Daytime Diastolic Blood Pressure (DBP)|The daytime diastolic blood pressure was calculated as the average diastolic blood pressure during the daytime period based on 24 hour ambulatory blood pressure monitoring. Means of multiple measurements were reported|At the end of 4 weeks|37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls.||mmHg||Standard Error|Mean
839183|NCT01324622|Secondary|Pain Scores on the Visual Analog Scale||Up to 24 months|Due to the study’s early termination, no data were collected for this outcome.|||||
817700|NCT01114360|Secondary|Mean Nighttime Heart Rate (HR)|Nighttime heart rate is number of pulsations of the heart per unit of time during nighttime sleep. It is measured in beats per minute (bpm). Ambulatory blood pressure monitoring was used to calculate the heart rate. Means of multiple measurements were reported|At the end of 4 weeks|37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls.||beats per minute||Standard Error|Mean
817701|NCT01114360|Secondary|Mean Nighttime Mean Arterial Pressure (MAP)|Nighttime mean arterial pressure (MAP) is the average blood pressure in the subject's arteries during one cardiac cycle (one complete heartbeat) at night. It is calculated using the formula, MAP = 1/3(SBP-DBP)+DBP; where SBP is the systolic blood pressure and DBP is the diastolic blood pressure. Means of multiple measurements were reported|At the end of 4 weeks|37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls.||mmHg||Standard Error|Mean
817702|NCT01114360|Primary|Mean Nighttime Systolic Blood Pressure (SBP)|The nighttime systolic blood pressure (SBP) was recorded using an ambulatory blood pressure (ABP) monitor. The measurements occurring from the onset of self-reported sleep to the end of self-reported sleep were recorded. Means of multiple measurements were reported.|At the end of 4 weeks|37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls.||mmHg||Standard Error|Mean
817703|NCT01114373|Secondary|Total Sleep Time|The total sleep time will be measured by polysomnography (PSG) using an Embla polysomnograph. The nocturnal total sleep time (TST) or the the total number of minutes in any stage of sleep during the major nocturnal sleep period was measured by PSG.|4 weeks|40 subjects enrolled the study. 4 subjects did not complete the study. 36 subjects completed the study in a crossover design, being their own controls.||minutes||Standard Error|Mean
817704|NCT01114373|Secondary|Plasma P-Selectin|P-Selectin is a marker of endothelial function. Levels of p-selectin were measured from stored plasma using enzyme-linked immunosorbent assay (ELISA).|4 weeks|40 subjects enrolled the study. 4 subjects did not complete the study. 36 subjects completed the study in a crossover design, being their own controls.||ng/ml||Standard Error|Mean
817705|NCT01114373|Secondary|Plasma E-Selectin|E-Selectin is a marker of endothelial function. Levels of e-selectin were measured from stored plasma using enzyme-linked immunosorbent assay (ELISA).|4 weeks|40 subjects enrolled the study. 4 subjects did not complete the study. 36 subjects completed the study in a crossover design, being their own controls.||ng/ml||Standard Error|Mean
817706|NCT01114373|Secondary|Urinary Adrenaline Excretion Rate|The rate of urinary adrenaline excretion was measured by the Enzyme-Linked Immunosorbent Assay (ELISA) method from urine samples collected overnight.|4 weeks|40 subjects enrolled the study. 4 subjects did not complete the study. 36 subjects completed the study in a crossover design, being their own controls.||ng/ml/min||Standard Error|Mean
817707|NCT01114373|Secondary|Urinary Noradrenaline Excretion Rate|The rate of urinary noradrenaline excretion was measured by the Enzyme-Linked Immunosorbent Assay (ELISA) method from urine samples collected overnight.|4 weeks|40 subjects enrolled the study. 4 subjects did not complete the study. 36 subjects completed the study in a crossover design, being their own controls.||ng/ml/min||Standard Error|Mean
817708|NCT01114373|Secondary|Urinary Dopamine Excretion Rate|The rate of urinary dopamine excretion was measured by the Enzyme-Linked Immunosorbent Assay (ELISA) method from urine samples collected overnight.|4 weeks|40 subjects enrolled the study. 4 subjects did not complete the study. 36 subjects completed the study in a crossover design, being their own controls.||ng/ml/min||Standard Error|Mean
817709|NCT01114373|Secondary|Mean Daytime Heart Rate (HR)|Daytime heart rate is the number of pulsations of the heart per unit of time. It is measured in beats per minute (bpm). The ambulatory blood pressure monitor was used to calculate the heart rate. Means of multiple measurements are reported.|4 weeks|40 subjects enrolled the study. 4 subjects did not complete the study. 36 subjects completed the study in a crossover design, being their own controls.||beats per minute||Standard Error|Mean
817710|NCT01114373|Secondary|Mean Daytime Mean Arterial Pressure (MAP)|Daytime mean arterial pressure (MAP) is the average blood pressure in the subject's arteries during one cardiac cycle (one complete heartbeat) during the day. It is calculated using the formula, MAP = 1/3(SBP-DBP)+DBP; where SBP is the systolic blood pressure and DBP is the diastolic blood pressure. Means of multiple measurements are reported.|4 weeks|40 subjects enrolled the study. 4 subjects did not complete the study. 36 subjects completed the study in a crossover design, being their own controls.||mmHg||Standard Error|Mean
817711|NCT01114373|Secondary|Mean Daytime Diastolic Blood Pressure (DBP)|The daytime diastolic blood pressure was calculated as the average diastolic blood pressure during the daytime period based on 24 hour ambulatory blood pressure monitoring. Means of multiple measurements are reported.|4 weeks|40 subjects enrolled the study. 4 subjects did not complete the study. 36 subjects completed the study in a crossover design, being their own controls.||mmHg||Standard Error|Mean
817712|NCT01114373|Secondary|Mean Daytime Systolic Blood Pressure (SBP)|The daytime systolic blood pressure was calculated as the average systolic blood pressure during daytime period based on 24hour ambulatory blood pressure monitoring. Means of multiple measurements are reported.|4 weeks|40 subjects enrolled the study. 4 subjects did not complete the study. 36 subjects completed the study in a crossover design, being their own controls.||mmHg||Standard Error|Mean
817713|NCT01114373|Secondary|Mean Nighttime Heart Rate (HR)|Nighttime heart rate is the number of pulsations of the heart per unit of time. It is measured in beats per minute (bpm). The ambulatory blood pressure monitor was used to calculate the heart rate. Means of multiple measurements are reported.|4 weeks|40 subjects enrolled the study. 4 subjects did not complete the study. 36 subjects completed the study in a crossover design, being their own controls.||beats per minute||Standard Error|Mean
817714|NCT01114373|Secondary|Mean Nighttime Mean Arterial Pressure (MAP)|Nighttime mean arterial pressure (MAP) is the average blood pressure in the subject's arteries during one cardiac cycle (one complete heartbeat) at night. It is calculated using the formula, MAP = 1/3(SBP-DBP)+DBP; where SBP is the systolic blood pressure and DBP is the diastolic blood pressure. Means of multiple measurements are reported.|4 weeks|40 subjects enrolled the study. 4 subjects did not complete the study. 36 subjects completed the study in a crossover design, being their own controls.||mmHg||Standard Error|Mean
817715|NCT01114373|Primary|Mean Nighttime Diastolic Blood Pressure (DBP)|The nighttime diastolic blood pressure (DBP) was recorded using an ambulatory blood pressure (ABP) monitor. The measurements occurring from the onset of self-reported sleep to the end of self-reported sleep were recorded. Means of multiple measurements are reported.|4 weeks|40 subjects enrolled the study. 4 subjects did not complete the study. 36 subjects completed the study in a crossover design, being their own controls.||mmHg||Standard Error|Mean
817716|NCT01114373|Primary|Mean Nighttime Systolic Blood Pressure (SBP)|The nighttime systolic blood pressure (SBP) was recorded using an ambulatory blood pressure (ABP) monitor. The measurements occurring from the onset of self-reported sleep to the end of self-reported sleep were recorded. Means of multiple measurements are reported.|4 weeks|40 subjects enrolled the study. 4 subjects did not complete the study. 36 subjects completed the study in a crossover design, being their own controls.||mmHg||Standard Error|Mean
817717|NCT01114438|Primary|Change From Baseline in SF 36v2 Quality of Life Assessment|Quality of life was measured using Survey Form SF-36v2 licensed from Quality Metric, Inc (Lincoln, RI). Physical and Mental component scores were measured at baseline, month 12 (at the time of explant) and 6 months post explant with results self-recorded by each subject. The SF-36 v2 physical component summary (PCS) score as well as the mental component summary score (MCS) ranged between 0 and 100, with higher scores reflecting better quality of life in each case.|Baseline, 12 months (explant), 6 months post explant (18 months post baseline)|The number of participants analyzed reflects all participants who received the implant and were assessed for QoL at the respective time points.||units on a scale||Standard Deviation|Mean
817718|NCT01114438|Primary|Changes in Diabetic Medications at Treatment Completion Compared to Baseline|number of patients with a decrease, increase or no change in diabetic medications at time of EndoBarrier explantation (treatment completion)|12 months|Analysis was conducted on subjects with a device||Participants|||Count of Participants
817719|NCT01114438|Primary|Total Weight Change From Baseline to Week 52|Total weight change at 12 months (kg) compared to baseline|12 months|Analysis was conducted on the Full Analysis Set (FAS) defined as all subjects enrolled and implanted with the EndoBarrier, There were 29 subjects' data available for weight loss analysis at the defined 12 month endpoint.||kg||Standard Deviation|Mean
817720|NCT01114438|Primary|HbA1c (%) Measured at Week 52||12 months|Analysis was conducted on the Full Analysis Set (FAS) defined as all subjects enrolled and implanted with the EndoBarrier, There were 29 subjects' data available for analysis of HbA1c at the defined 12 month (week 52) endpoint.||% glycated hemoglobin||Full Range|Median
817721|NCT01114503|Secondary|Assessment of Exploratory Biomarkers of Ribonucleic Acid (RNA) Transcription Analysis of Peripheral Blood|The exploratory biomarkers of RNA transcription analysis of peripheral blood was planned to be assessed on Day 1(pre dose), Week 4 and Week 24. The assessment was to be done using microarray and RNA expression using quantitative reverse transcription polymerase chain reaction (RT-PCR). This endpoint was not analyzed due to the early termination of the study and since only 2 participants were recruited.|Up to Week 24|All Subjects Population. No participants were available for analysis because of early termination of study.|||||
817722|NCT01114503|Secondary|Assessment of Exploratory Biomarkers|The exploratory biomarkers were planned to be assessed on Day 1 (pre dose), Week 4, Week 12 and Week 24. It included assessment of peripheral blood mononuclear cells (PBMC) markers, suppression assays for the measure of effector cell proliferation, quantification of effector memory T-cells subsets, autoreactivity assays using cytokine production of supernatants and CFSE dilution, cytokine production by in-vitro stimulated T-cells, circulating serum biomarkers and may include subsequently discovered biomarkers of the biological response associated with GO or medically related conditions and/or the action of otelixizumab. This endpoint was not analyzed due to the early termination of the study and since only 2 participants were recruited.|Up to Week 24|All Subjects Population. No participants were available for analysis because of early termination of study.|||||
817723|NCT01114503|Secondary|Assessment of Circulating Cytokines of Interleukin 6 (IL6), IL10, Interferon Gamma (IFNγ) and Tumor Necrosis Factor Alpha (TNFα) up to 2 Weeks|Assessment of circulating cytokines of IL6, IL10, IFNγ and TNFα was planned to be assessed on Day 1-8 (pre dose) and Week 12. This endpoint was not analyzed due to the early termination of the study and since only 2 participants were recruited.|Up to Week 2|All Subjects Population. No participants were available for analysis because of early termination of study.|||||
817724|NCT01114503|Secondary|Assessment of Anti-otelixizumab Antibodies|Anti-otelixizumab antibodies were planned to be assessed on Day 1 (pre dose), Day 8 (pre dose), Week 4-24 and Month 12. This endpoint was not analyzed due to the early termination of the study and since only 2 participants were recruited.|Up to Month 12|All Subjects Population. No participants were available for analysis because of early termination of study.|||||
817725|NCT01114503|Secondary|Change From Baseline Measurement of Orbital Volume as Measured by Computed Tomography (CT) Scan|The assessment of orbital volume measured by CT scan was planned to be assessed on Week 12 and Week 24. Baseline was referred to assessment at Screening. Change from Baseline was defined as post-Baseline value minus Baseline value. This endpoint was not analyzed due to the early termination of the study and since only 2 participants were recruited.|Baseline (Screening), Week 12 and Week 24|All Subjects Population. No participants were available for analysis because of early termination of study.|||||
817726|NCT01114503|Secondary|Change From Baseline for Participant-reported Health Related Quality of Life (QoL) Questionnaires of Short Form 36 ( SF-36) and Graves Ophthalmopathy (GO) QoL|Assessment of health related QoL was planned to be evaluated using the validated, disease specific, GO-QoL questionnaire and the SF-36 health survey questionnaire at Day 1 (pre dose) and Week 2- 24. Mean scores range from 0 (minimum) - 100 (maximum) with higher mean scores reflected better outcomes. Baseline was referred to assessment on Day 1 (pre dose). Change from Baseline was defined as post-Baseline value minus Baseline value. This endpoint was not analyzed due to the early termination of the study and since only 2 participants were recruited.|Baseline (Day 1, pre dose) to Week 24|All Subjects Population. No participants were available for analysis because of early termination of study.|||||
817727|NCT01114503|Secondary|Change From Baseline for Individual Scores at Week 12 Incorporated in the European Group on Graves’ Orbitopathy (EUGOGO) Assessment Including, Eyelid Swelling, Clinical Activity Score (CAS) Score, Proptosis, Lid Width and Diplopia|The EUGOGO assessment of change was defined by improvement or deterioration of clinical scores. Improvement in EUGOGO was defined as improvement in two of the following measures in at least one eye, without deterioration in any of the same measures in both eyes: eyelid swelling according to color atlas evaluation, CAS by at least 2 points, proptosis by at least 2 millimeter (mm) by Hertel exophthalmometer, lid width by at least 2 mm, diplopia (disappearance or change in the degree) or improvement of >=8 degrees in motility unexplained by commensurate deterioration of motility of ipsilateral antagonists. Deterioration was defined by worsening by same quantity (as for improvement) of the same measures. Baseline was referred to assessment on Day 1 (pre dose). Change from Baseline was defined as post-Baseline value minus Baseline value. This endpoint was not analyzed due to the early termination of the study and since only 2 participants were recruited.|Baseline (Day 1, pre dose) and Week 12|All Subjects Population. No participants were available for analysis because of early termination of study.|||||
817728|NCT01114503|Primary|Assessment of CD3/T-cell Receptor (TCR) Complex Saturation and Modulation|The assessment of CD3/TCR complex saturation and modulation was planned to be assessed on Day (1-8) pre dose, Week 2, Week 4, Week 8, Week 12 and Week 24. The extent of modulation was to be determined by the extent of TCR alpha beta (αβ) expression which was proportional to the combined levels of free CD3 sites and bound otelixizumab to CD4+ and CD8+ T cells. Bound levels of otelixizumab was planned to be determined by using flow cytometry method using an anti Immunoglobulin (Ig) antibody. The molecules of equivalent soluble fluorochrome (MESF) of the anti-Ig antibody was to be used to quantify the levels of bound otelixizumab present on T cells. Free otelixizumab binding sites (i.e., sites not occupied by otelixizumab administered to the participants) was to be detected by staining with fluorescein isothiocyanate (FITC) labelled otelixizumab. This endpoint was not analyzed due to the early termination of the study and since only 2 participants were recruited.|Up to Week 24|All Subjects Population. No participants were available for analysis because of early termination of study.|||||
817729|NCT01114503|Primary|Percentage of Circulating Peripheral T-cells, CD4+ and CD8+ Subset Counts|The lymphocyte subsets of T-cells, CD4+ and CD8+ cells were planned to be assessed at Day 1 (pre dose), Day 8 (pre dose), Week 2, Week 4, Week 8, Week 12 and Week 24. The percentages of relevant lymphocyte subsets was to be determined by flow cytometry. This endpoint was not analyzed due to the early termination of the study and since only 2 participants were recruited.|Up to Week 24|All Subjects Population. No participants were available for analysis because of early termination of study.|||||
817730|NCT01114503|Primary|Individual Absolute Circulating Peripheral T Lymphocytes (T-cells), CD4+ and CD8+ Subset Counts|The lymphocyte subsets of T-cells, CD4+ and CD8+ cells were planned to be assessed at Day 1 (pre dose), Day 8 (pre dose), Week 2, Week 4, Week 8, Week 12 and Week 24. The absolute counts of the relevant lymphocyte subsets was to be determined by multiplying the percentages of the cell subsets with total lymphocyte counts. The percentages of relevant lymphocyte subsets was to be determined by flow cytometry. This endpoint was not analyzed due to the early termination of the study and since only 2 participants were recruited.|Up to Week 24|All Subjects Population. No participants were available for analysis because of early termination of study.|||||
817731|NCT01114503|Primary|Number of Participants With an Epstein Barr Virus (EBV) Viral Load Abnormalities Meeting the Criteria for PCC|The PCC range for EBV viral load was > 10,000 copies of deoxyribonucleic acid (DNA) per million lymphocytes. The assessments were done at Week 2, Week 4, Week 8 and Week 12.|Week 2 to Week 12|All Subjects Population||Participants|||Number
817732|NCT01114503|Primary|Number of Participants With Electrocardiogram (ECG) Abnormalities Meeting the Criteria for PCC|ECG parameters included pulse rate (PR) interval, QRS interval, QT interval, corrected QT interval using Bazett's formula (QTcB) and corrected QT interval using Fridericia's formula (QTcF). Criteria for ECG changes meeting potential clinical concern included: PR interval <110 and >220 milliseconds (msec); QRS interval <75 and >110 msec; QTc interval >480 to <= 500 msec, increase from baseline QTc >30 to <= 60 msec.|Screening (Day –35 to Day –1)|All Subjects Population||Participants|||Number
817733|NCT01114503|Primary|Number of Participants With Vital Signs Abnormalities Meeting the Criteria for PCC|Vital signs assessment included pulse rate, blood pressure, temperature and respiratory rate. Criteria for vital sign values meeting potential clinical concern included: supine pulse rate <40 or >110 beats per minute (bpm), >= 15 increase from baseline and >= 30 decrease from baseline; systolic blood pressure (SBP) < 85 and > 160 millimeters of mercury (mm Hg), >= 20 mmHg increase from baseline and >= 40 mmHg decrease from baseline; diastolic blood pressure (DBP) < 45 and > 100 mm Hg, >= 10 mmHg increase from baseline and >= 20 mmHg decrease from baseline.|Up to Month 24 (Long term follow-up)|All Subjects Population||Participants|||Number
817734|NCT01114503|Primary|Number of Participants With Thyroid Function Assessment, Hormone and Glucose Assay Abnormalities Meeting the Criteria for PCC|The following laboratory parameters were analyzed: thyroid function assessment (thyroid stimulating hormone [TSH], thyroid peroxidase antibody, thyrotropin receptor antibodies (TSH-R-Abs) or TSH-binding inhibiting immunoglobulin (TBII), free thyroxine [fT4], free triiodothyronine [fT3]; hormone and glucose assays (cortisol, adrenocorticotrophic hormone [ACTH], insulin-like growth factor [IgF-1] and plasma glucose. Thyroid function tests were done at Day 1 (pre-dose) and Week 4-24. Hormone and glucose assays were done at Day 1 (pre-dose) and Week 2-24.|Up to Week 24|All Subjects Population||Participants|||Number
817735|NCT01114503|Primary|Number of Participants With Laboratory Urinalysis Abnormalities Meeting the Criteria for PCC|The urinalysis parameters included pH, glucose, protein, blood and ketones by dipstic and microscopy (if urine dipstick was positive for blood or protein). The assessments were done at Day 1 (pre dose), Day 8, Week 2-24, Month 12 and 24.|Up to Month 24 (Long term follow-up)|All Subjects Population||Participants|||Number
817736|NCT01114503|Primary|Number of Participants With Laboratory Hematology Abnormalities Meeting the Criteria for PCC|The PCC range for hematology parameters included white blood cell count, low- < 3 giga cells (GI)/L, high- > 20 GI/L; neutrophil count, low- < 1.5 GI/L; hemoglobin, low- > 25 g/L change from baseline, high- 180 g/L; hematocrit, low- > 0.075 L change from baseline, high- 0.54 L; platelet count, low- < 100 GI/L, high- >550 GI/L and lymphocytes, low < 0.8 GI/L. The assessments were done at Day 1 (pre dose), Day 8, Week 2-24, Month 12 and 24.|Upto Month 24 (Long term follow-up)|All Subjects Population||Participants|||Number
817737|NCT01114503|Primary|Number of Participants With Laboratory Clinical Chemistry Abnormalities Meeting the Criteria for Potential Clinical Concern (PCC)|The PCC range for clinical chemistry parameters included albumin, <30 gram per liter (g/L); calcium, low- < 2.0 millimole (mmol)/L: high->2.75 mmol/L; creatinine, high- > 1.3x ULN mmol/L or > 159 micromole (μmol)/L or > 44 μmol/L change from Baseline; glucose, low- < 3.0 mmol/L, high- > 9.0 0 mmol/L; magnesium, low- < 0.5 mmol/L, high- > 1.23 mmol/L, phosphorus, low- < 0.8 mmol/L, high- > 1.6 mmol/L; potassium, Low- < 3.0 mmol/L, high- > 5.5 mmol/L; sodium, low- < 130 mmol/L, high- > 150 mmol/L; bicarbonate, low- < 18 mmol/L, high- > 32 mmol/L; alanine aminotransferase, high->= 2x ULN, where the normal range was (NR) 0 – 39 international units (IU)/L; aspartate aminotransferase, high- >= 2x ULN, where NR was 0 – 39 IU/L; alkaline phosphatase, high- >= 1.5x ULN, where NR was 35 – 120 IU/L; total bilirubin- >= 1.5x ULN, where NR was 0 – 18 μmol/L.The assessments were done at Day 1 (pre dose), Day 8, Week 2-24 and Month 12 and 24.|Up to Month 24 (Long term follow-up)|All Subjects Population||Participants|||Number
817738|NCT01114503|Primary|Number of Participants With at Least One Adverse Event (AE), Serious Adverse Event (SAE), or Drug-related Adverse Event|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, associated with liver injury and impaired liver function defined as alanine aminotransferase >=3 x upper limit of normal (ULN), and total bilirubin >=2 x ULN or international normalized ratio >1.5. The classification as potentially drug-related was done based on the investigator's judgment.|Up to Month 24 (Long term follow-up)|All Subjects Population included all participants who receive at least one dose of study medication.||Participants|||Number
817739|NCT01114516|Secondary|Birthweight|Median birthweight|24 weeks|||grams||Inter-Quartile Range|Median
817740|NCT01114516|Secondary|Neonatal Morbidity and Mortality|Days spent in the neonatal intensive care unit|1 year|||days||Inter-Quartile Range|Median
817741|NCT01114516|Secondary|Gestational Age at Delivery|Median gestational age at delivery|24 weeks|||weeks||Inter-Quartile Range|Median
817742|NCT01114516|Secondary|Gestational Latency of More Than 28 Days|The frequency of achieving a gestational latency of more than 28 days|28 days postpartum|||percentage of participants|||Number
817743|NCT01114516|Primary|Gestational Latency Achieved Between Cerclage Placement and Time of Delivery|Median gestational latency achieved Between Cerclage Placement and Time of Delivery|24 weeks|||days||Inter-Quartile Range|Median
817744|NCT01114529|Secondary|Comparison of Incidence Rates of Efficacy Endpoints Between Treatment Arms (Full Analysis Set - 24 Month Analysis)|(treated BPAR ≥ IB, graft loss or death)A comparison of the incidence rates for the individual components of the composite efficacy endpoint between treatment arms|at 24 months post-transplantation|Full Analysis Set||Number of incidence|||Number
817745|NCT01114529|Secondary|Change in Left Ventricular Mass Index (LVMi) From Randomization to Month 12 and Month 24|Evolution of left ventricular mass and hypertrophy were evaluated by left ventricular mass index (LVMi) assessed by echocardiography. LVMi is derived using a standard formula from dimensional measurements on the echocardiogram. Analysis of covariance was applied with treatment, center (as a random effect), and donor type as factors and LVMi at Randomization as covariate.|Randomization, Month 12 and Month 24|Full Analysis Set consists of only patients with triple LVMi values available at randomization, Month 12 and month 24 are included||g/m^2.7||Standard Deviation|Mean
817746|NCT01114529|Secondary|Incidence of Composite Efficacy Endpoint for Each Arm at Month 12 and Month 24|Efficacy failure rate used the composite endpoint of: (1) treated biopsy-proven acute rejection (BPAR)*, (2) graft loss**, or (3) death . *A treated BPAR was defined as a biopsy graded IA, IB, IIA, IIB, or III and which was treated with anti-rejection therapy. **Graft loss is defined as when the allograft was presumed lost on the day the participant started dialysis and was not able to subsequently be removed from dialysis or re-transplanted.|at 12 months and month 24 post-transplantation|Full Analysis Set||Number of incidence|||Number
817747|NCT01114529|Primary|Estimated Glomerular Filtration Rate (eGFR)|Assessment of renal function by comparing change from randomization to Month 12 in eGFR ‎‎(MDRD4) between treatment arms (Full analysis set). Renal function was assessed by estimated Glomerular Filtration Rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) formula. MDRD formula: GFR [mL/min/1.73m˄2] = 186.3*(C˄-1.154)*(A˄-0.203)*G*R. DEFINITIONS: C = serum concentration of creatinine [mg/dL]; A = age [years]; G = 0.742 when gender is female, otherwise G = 1; R = 1.21 when race is black, otherwise R = 1‎|Month 12|Full Analysis set - observed eGFR values at month 12 (counted the patients with available values)||mL/min/1.73m^2||Standard Deviation|Mean
817748|NCT01114581|Secondary|Assess Sputum Properties (Objective Measures) and Symptoms (Subjective Measures) After Treatment With Mucinex or Placebo.||Within 10 days of developing symptoms associated with a respiratory tract infection||||||
817749|NCT01114581|Secondary|Guaifenesin AUC(0-3)||3 hours following dose administration|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
817750|NCT01114581|Primary|Percent of Inhaled Radioactive Tracer Particles Cleared From Lungs|Percentage of inhaled radioactive tracer (Ave180Clear)|3 hours following inhalation of radioactive tracer particles|Intent to treat||Percentage of inhaled radioactive tracer||Standard Deviation|Mean
817751|NCT01114672|Primary|Severity of Pruritis|"Randomized patients will fill out a survey with questions about the degree and location of their pruritis at baseline and end of study. The total score ranged from 0-21 with 21 being the most severe and zero being the absence of any of the measures of pruritis.
Last observation was carried forward to end of study. A decrease in the Severity of Pruritis score over time indicated an improvement in the severity of pruritis."|Baseline and end of study (up to 12 weeks)|Number randomized in each arm 25||units on a scale||Standard Deviation|Mean
817767|NCT01114737|Secondary|Change in Behavior Rating Inventory of Executive Function (BRIEF) Parent-Global Executive Composite (GEC) T Score From Baseline to Week 26|"Durability of the therapeutic effect of 6R-BH4 on executive function through 26 weeks in subjects who had a blood Phe level reduction after treatment with 6R-BH4.
The scoring for the GEC T Score is complex and is achieved using proprietary software designed to generate scores based on raw data collected. Higher scores suggest a higher level of dysfunction."|Baseline to Week 26|||T score||95% Confidence Interval|Least Squares Mean
817768|NCT01114737|Secondary|Change in Behavior Rating Inventory of Executive Function (BRIEF) Adult-Global Executive Composite (GEC) T Score From Baseline to Week 26|"Durability of the therapeutic effect of 6R-BH4 on executive function through 26 weeks in subjects who had a blood Phe level reduction after treatment with 6R-BH4.
The scoring for the GEC T Score is complex and is achieved using proprietary software designed to generate scores based on raw data collected. Higher scores suggest a higher level of dysfunction."|Baseline to Week 26|||T score||95% Confidence Interval|Least Squares Mean
817769|NCT01114737|Primary|Number of Participants With a Score of 1 or 2 in Global Function Evaluation (CGI-I) From Baseline to Week 13.|"Effects of 6R-BH4 on global function in PKU subjects in subjects that had a blood Phe level reduction after treatment with 6R-BH4 at screening.
The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse."|13 weeks|Missing data for 1 subject in the Responders in 6R-BH4 20 mg/kg/day Arm||Number of participants with scale 1 or 2|||Number
817770|NCT01114737|Secondary|Change in Clinical Global Impression-Severity (CGI-S) From Baseline to Week 26|"Durability of the therapeutic effect of 6R-BH4 on global function through 26 weeks in subjects who had a blood Phe level reduction after treatment with 6R-BH4.
CGI-S is a 7-point scale that requires the clinician to rate the severity of the subject’s mental illness at the time of assessment, relative to clinician’s past experience with subjects who have the same diagnosis. Considering total clinical experience, a subject is assessed on the severity of mental illness at the time of rating as: 1, normal, not at all ill; 2, borderline ill; 3, mildly ill; 4, moderately ill; 6, severely ill; or 7, among the most extremely ill."|Baseline to Week 26|||units on a scale||95% Confidence Interval|Mean
817771|NCT01114737|Secondary|Change in Hamilton Rating Scale For Depression (HAM-D) Score From Baseline to Week 26|"Durability of the therapeutic effect of 6R-BH4 on depression through 26 weeks in subjects who had a blood Phe level reduction after treatment with 6R-BH4.
HAM-D Score is a total score ranging from 0 to 48 with higher scores corresponding to worse severity of depression. The HAM-D is a 17-item depression rating scale. Nine of the items are scored on a 5-point scale as: 0, absence of depressive symptom being measured; 1, doubt concerning the presence of the symptom; 2, mild symptoms; 3, moderate symptoms; or 4, severe symptoms. The remaining 8 items are scored on a 3-point scale as: 0, absence; 1, doubt on the presence of the symptom; or 2, clear presence of symptoms."|Baseline to Week 26|||units on a scale||95% Confidence Interval|Least Squares Mean
817772|NCT01114737|Secondary|Change in Hamilton Anxiety Rating Scale (HAM-A) Score From Baseline to Week 26|"Durability of the therapeutic effect of 6R-BH4 on anxiety through 26 weeks in subjects who had a blood Phe level reduction after treatment with 6R-BH4.
HAM-A Score is a total score ranging from 0 to 56 with higher scores corresponding to worse severity of anxiety symptoms. The HAM-A has 14 items, each measuring specific anxiety symptom clusters. Each item is given a 5-point-score as: 0, absent; 1, mild; 2, moderate; 3, severe; or 4, incapacitating."|Baseline to Week 26|||units on a scale||95% Confidence Interval|Least Squares Mean
817773|NCT01114737|Secondary|Change in Attention-Deficit Hyperactivity Disorder Rating Scale-IV (ADHD-RS) / Adult ADHD Self-Report Scale (ASRS) Total Score From Baseline to Week 26|"Durability of the therapeutic effect of 6R-BH4 on ADHD through 26 weeks in subjects who had a blood Phe level reduction after treatment with 6R-BH4.
The total ADHD-RS score and the corrected total ARS score range from 0 to 54, with higher scores corresponding to worse severity of ADHD symptoms."|Baseline to Week 26|||units on a scale||95% Confidence Interval|Least Squares Mean
817774|NCT01114737|Secondary|Change in Behavior Rating Inventory of Executive Function (BRIEF) Parent-Global Executive Composite (GEC) T Score From Week 13 to Week 26|"Durability of the therapeutic effect of 6R-BH4 on executive function through 26 weeks in subjects who had a blood Phe level reduction after treatment with 6R-BH4.
The scoring for the GEC T Score is complex and is achieved using proprietary software designed to generate scores based on raw data collected. Higher scores suggest a higher level of dysfunction."|Week 13 to Week 26|Phe Responders who is <18 Years of Age||T score||95% Confidence Interval|Least Squares Mean
819838|NCT01138475|Secondary|Serum Calcium|This secondary outcome measure is change in serum calcium from baseline to final measure at 6 weeks differences in the 3 arms were compared|6 weeks|missing data from participant in paricalcitrol||mg/dL||Standard Error|Mean
817775|NCT01114737|Secondary|Change in Behavior Rating Inventory of Executive Function (BRIEF) Adult-Global Executive Composite (GEC) T Score From Week 13 to Week 26|"Durability of the therapeutic effect of 6R-BH4 on executive function through 26 weeks in subjects who had a blood Phe level reduction after treatment with 6R-BH4.
The scoring for the GEC T Score is complex and is achieved using proprietary software designed to generate scores based on raw data collected. Higher scores suggest a higher level of dysfunction."|Week 13 to Week 26|Phe Responders who is >=18 Years of Age||T score||95% Confidence Interval|Least Squares Mean
817776|NCT01114737|Secondary|Change in Clinical Global Impression-Severity (CGI-S) From Week 13 to Week 26|"Durability of the therapeutic effect of 6R-BH4 on global function through 26 weeks in subjects who had a blood Phe level reduction after treatment with 6R-BH4.
CGI-S is a 7-point scale that requires the clinician to rate the severity of the subject’s mental illness at the time of assessment, relative to clinician’s past experience with subjects who have the same diagnosis. Considering total clinical experience, a subject is assessed on the severity of mental illness at the time of rating as: 1, normal, not at all ill; 2, borderline ill; 3, mildly ill; 4, moderately ill; 6, severely ill; or 7, among the most extremely ill."|Week 13 to Week 26|Phe Responders||units on a scale||95% Confidence Interval|Least Squares Mean
817777|NCT01114737|Secondary|Change in Hamilton Depression Rating Scale (HAM-D) Score From Week 13 to Week 26|"Durability of the therapeutic effect of 6R-BH4 on depression through 26 weeks in subjects who had a blood Phe level reduction after treatment with 6R-BH4.
HAM-D Score is a total score ranging from 0 to 48 with higher scores corresponding to worse severity of depression. The HAM-D is a 17-item depression rating scale. Nine of the items are scored on a 5-point scale as: 0, absence of depressive symptom being measured; 1, doubt concerning the presence of the symptom; 2, mild symptoms; 3, moderate symptoms; or 4, severe symptoms. The remaining 8 items are scored on a 3-point scale as: 0, absence; 1, doubt on the presence of the symptom; or 2, clear presence of symptoms."|Week 13 to Week 26|Phe Responders||units on a scale||95% Confidence Interval|Least Squares Mean
817778|NCT01114737|Secondary|Change in Hamilton Anxiety Rating Scale (HAM-A) Score From Week 13 to Week 26|"Durability of the therapeutic effect of 6R-BH4 on anxiety through 26 weeks in subjects who had a blood Phe level reduction after treatment with 6R-BH4.
HAM-A Score is a total score ranging from 0 to 56 with higher scores corresponding to worse severity of anxiety symptoms. The HAM-A has 14 items, each measuring specific anxiety symptom clusters. Each item is given a 5-point-score as: 0, absent; 1, mild; 2, moderate; 3, severe; or 4, incapacitating."|Week 13 to Week 26|Phe Responders||units on a scale||95% Confidence Interval|Least Squares Mean
817779|NCT01114737|Secondary|Change in Attention-Deficit Hyperactivity Disorder Rating Scale-IV (ADHD-RS) / Adult ADHD Self-Report Scale (ASRS) Total Score From Week 13 to Week 26|"Durability of the therapeutic effect of 6R-BH4 on ADHD through 26 weeks in subjects who had a blood Phe level reduction after treatment with 6R-BH4.
The total ADHD-RS score and the corrected total ARS score range from 0 to 54, with higher scores corresponding to worse severity of ADHD symptoms."|Week 13 to Week 26|Phe Responders with ADHD Symptoms||units on a scale||95% Confidence Interval|Least Squares Mean
817780|NCT01114737|Secondary|Change in Behavior Rating Inventory of Executive Function (BRIEF) Parent-Global Executive Composite (GEC) T Score From Baseline to Week 13|"Effects of 6R-BH4 on executive function in PKU subjects who had a blood Phe level reduction after treatment with 6R-BH4.
The scoring for the GEC T Score is complex and is achieved using proprietary software designed to generate scores based on raw data collected. Higher scores suggest a higher level of dysfunction."|Baseline to Week 13|Phe Responders who are <18 Years of Age||T score||95% Confidence Interval|Least Squares Mean
817781|NCT01114737|Secondary|Change in Behavior Rating Inventory of Executive Function (BRIEF) Adult-Global Executive Composite (GEC) T Score From Baseline to Week 13|"Effects of 6R-BH4 on executive function in PKU subjects who had a blood Phe level reduction after treatment with 6R-BH4.
The scoring for the GEC T Score is complex and is achieved using proprietary software designed to generate scores based on raw data collected. Higher scores suggest a higher level of dysfunction."|Baseline to Week 13|Phe Responders who are >=18 Years of Age||T score||95% Confidence Interval|Least Squares Mean
817782|NCT01114737|Secondary|Change in Clinical Global Impression-Severity (CGI-S) From Baseline to Week 13|"Effects of 6R-BH4 on global function in PKU subjects who had a blood Phe level reduction after treatment with 6R-BH4.
CGI-S is a 7-point scale that requires the clinician to rate the severity of the subject’s mental illness at the time of assessment, relative to clinician’s past experience with subjects who have the same diagnosis. Considering total clinical experience, a subject is assessed on the severity of mental illness at the time of rating as: 1, normal, not at all ill; 2, borderline ill; 3, mildly ill; 4, moderately ill; 6, severely ill; or 7, among the most extremely ill."|Baseline to Week 13|Phe Responders||units on a scale||95% Confidence Interval|Least Squares Mean
817783|NCT01114737|Secondary|Change in Hamilton Depression Rating Scale (HAM-D) Score From Baseline to Week 13|"Effects of 6R-BH4 on symptoms of depression in PKU subjects who had a blood Phe level reduction after treatment with 6R-BH4.
HAM-D Score is a total score ranging from 0 to 48 with higher scores corresponding to worse severity of depression. The HAM-D is a 17-item depression rating scale. Nine of the items are scored on a 5-point scale as: 0, absence of depressive symptom being measured; 1, doubt concerning the presence of the symptom; 2, mild symptoms; 3, moderate symptoms; or 4, severe symptoms. The remaining 8 items are scored on a 3-point scale as: 0, absence; 1, doubt on the presence of the symptom; or 2, clear presence of symptoms."|Baseline to Week 13|||units on a scale||95% Confidence Interval|Least Squares Mean
817784|NCT01114737|Secondary|Change in Hamilton Anxiety Rating Scale (HAM-A) Score From Baseline to Week 13|"Effects of 6R-BH4 on symptoms of anxiety in PKU subjects who had a blood Phe level reduction after treatment with 6R-BH4.
HAM-A Score is a total score ranging from 0 to 56 with higher scores corresponding to worse severity of anxiety symptoms. The HAM-A has 14 items, each measuring specific anxiety symptom clusters. Each item is given a 5-point-score as: 0, absent; 1, mild; 2, moderate; 3, severe; or 4, incapacitating."|Baseline to Week 13|||units on a scale||95% Confidence Interval|Least Squares Mean
817785|NCT01114737|Primary|Change in Attention-Deficit Hyperactivity Disorder Rating Scale-IV (ADHD-RS) / Adult ADHD Self-Report Scale (ASRS) Total Score From Baseline to Week 13|"Effects of 6R-BH4 on symptoms of ADHD in PKU subjects who had symptoms of ADHD at screening in the subjects that had a blood Phe level reduction after treatment with 6R-BH4.
The total ADHD-RS score and the corrected total ARS score range from 0 to 54, with higher scores corresponding to worse severity of ADHD symptoms."|Baseline to Week 13|||units on a scale||95% Confidence Interval|Least Squares Mean
817786|NCT01114828|Secondary|Ascites Volume as Measured by CT|Change from baseline (day-1) for ascites volume as measured by CT at the end of treatment (LOCF) were calculated.|Baseline, Day 7 or at the discontinued of treatment|For efficacy analysis set, 3 participants of 3.75 mg arm were excluded by violation of protocol and one participant of 7.5 mg arm was excluded by concomitant edematous disorders other than hepatic.||mL||Standard Deviation|Mean
817787|NCT01114828|Primary|Body Weight|Changes from baseline (day-1) for body weight at the end of treatment (LOCF) were calculated.|Bseline, Day 7 or at the discontined of treatment|For efficacy analysis set, 3 participants of 3.75 mg arm were excluded by violation of protocol and one participant of 7.5 mg arm was excluded by concomitant edematous disorders other than hepatic.||kg||Standard Deviation|Mean
817788|NCT01114880|Secondary|Change From Baseline in 36-item Short Form Questionnaire Version 2 (SF-36v2) Physical Component Summary Score|The SF-36 questionnaire, version 2, consists of 36 general health questions with 2 components, physical and mental. For each component, a transformed summary score is calculated using 8 sub-domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores range from 0 to 100. Higher scores indicate a better health state.|Baseline and Week 24|ITT analysis set, observed cases||units on a scale||Standard Deviation|Mean
817789|NCT01114880|Secondary|Change From Baseline in 36-item Short Form Questionnaire Version 2 (SF-36v2) Physical Component Summary Score|The SF-36 questionnaire, version 2, consists of 36 general health questions with 2 components, physical and mental. For each component, a transformed summary score is calculated using 8 sub-domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores range from 0 to 100. Higher scores indicate a better health state.|Baseline and Week 12|ITT analysis set, observed cases||units on a scale||Standard Deviation|Mean
817790|NCT01114880|Secondary|Change From Baseline in High-sensitivity C-Reactive Protein (Hs-CRP)|Elevation of hs-CRP is a nonspecific marker of inflammation. Values above 5 milligrams/liter (mg/L) were considered abnormally high. Decrease in level of hs-CRP indicates reduction in inflammation.|Baseline and Week 24|ITT analysis set, LOCF||milligrams/liter||Standard Deviation|Mean
817791|NCT01114880|Secondary|Change From Baseline in High-sensitivity C-Reactive Protein (Hs-CRP)|Elevation of hs-CRP is a nonspecific marker of inflammation. Values above 5 milligrams/liter (mg/L) were considered abnormally high. Decrease in level of hs-CRP indicates reduction in inflammation.|Baseline and Week 12|ITT analysis set, LOCF||milligrams/liter||Standard Deviation|Mean
817792|NCT01114880|Secondary|Number of Participants Meeting the Bath Ankylosing Spondyloarthritis Disease Activity Index (BASDAI) BASDAI50 Response Criteria|"A BASDAI50 responder had at least a 50% improvement from Baseline in BASDAI score. In the BASDAI, participants use a 10-centimeter visual analog scale to answer 6 questions pertaining to symptoms experienced in the preceding week (e.g., How would you describe the overall level of fatigue/tiredness you have experienced? How long does your morning stiffness last from the time you wake up?) Responses range from none to very severe or from 0 hours to 2 or more hours for morning stiffness. The score is calculated as 0.2 (Q1 + Q2 + Q3 + Q4 + Q5/2 + Q6/2)."|Week 24|ITT analysis set, missing data imputed by NRI||participants|||Number
817793|NCT01114880|Secondary|Number of Participants Meeting the Bath Ankylosing Spondyloarthritis Disease Activity Index (BASDAI) BASDAI50 Response Criteria|"A BASDAI50 responder had at least a 50% improvement from Baseline in BASDAI score. In the BASDAI, participants use a 10-centimeter visual analog scale to answer 6 questions pertaining to symptoms experienced in the preceding week (e.g., How would you describe the overall level of fatigue/tiredness you have experienced? How long does your morning stiffness last from the time you wake up?) Responses range from none to very severe or from 0 hours to 2 or more hours for morning stiffness. The score is calculated as 0.2 (Q1 + Q2 + Q3 + Q4 + Q5/2 + Q6/2)."|Week 12|ITT analysis set, missing data imputed by NRI||participants|||Number
817794|NCT01114880|Secondary|Change From Baseline in Inflammation Score|"The Inflammation score is the mean of the 10-cm visual analog scale scores from the 2 morning stiffness-related BASDAI questions: How would you describe the overall level of morning stiffness you have had from the time you wake up?, with response ranging from none to very severe; and How long does your morning stiffness last from the time you wake up?, with response ranging from 0 hours to 2 or more hours."|Baseline and Week 24|ITT analysis set, LOCF||centimeters||Standard Deviation|Mean
817795|NCT01114880|Secondary|Change From Baseline in Inflammation Score|"The Inflammation score is the mean of the 10-cm visual analog scale scores from the 2 morning stiffness-related BASDAI questions: How would you describe the overall level of morning stiffness you have had from the time you wake up?, with response ranging from none to very severe; and How long does your morning stiffness last from the time you wake up?, with response ranging from 0 hours to 2 or more hours."|Baseline and Week 12|ITT analysis set, LOCF||centimeters||Standard Deviation|Mean
817796|NCT01114880|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score|Participants assessed their ability to perform 10 selected activities (e.g., putting on socks or tights without help or aids, bending forward from the waist to pick up a pen from the floor without an aid) during the preceding week. Responses ranged from 0 (easy) to 100 (impossible). The BASFI score is the average of the 10 responses and has a possible minimum value of 0 and a possible maximum value of 100.|Baseline and Week 24|ITT analysis set, LOCF||units on a scale||Standard Deviation|Mean
817797|NCT01114880|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score|Participants assessed their ability to perform 10 selected activities (e.g., putting on socks or tights without help or aids, bending forward from the waist to pick up a pen from the floor without an aid) during the preceding week. Responses ranged from 0 (easy) to 100 (impossible). The BASFI score is the average of the 10 responses and has a possible minimum value of 0 and a possible maximum value of 100.|Baseline and Week 12|ITT analysis set, LOCF||units on a scale||Standard Deviation|Mean
817798|NCT01114880|Secondary|Change From Baseline in Total Back Pain Score|Participants assessed their total back pain within the preceding week using a total back pain 100 mm visual analog scale, with responses ranging from no pain (0) to most severe pain (100).|Baseline and Week 24|ITT analysis set, LOCF||millimeters||Standard Deviation|Mean
817799|NCT01114880|Secondary|Change From Baseline in Total Back Pain Score|Participants assessed their total back pain within the preceding week using a total back pain 100 mm visual analog scale, with responses ranging from no pain (0) to most severe pain (100).|Baseline and Week 12|ITT analysis set, LOCF||millimeters||Standard Deviation|Mean
817800|NCT01114880|Secondary|Change From Baseline in Patient Global Assessment of Disease Activity|Participants assessed their disease activity during the preceding week using a 100 millimeter (mm) visual analog scale, with responses ranging from no activity (0) to severe activity (100).|Baseline and Week 24|ITT analysis set, missing data imputed by last observation carried forward (LOCF)||millimeters||Standard Deviation|Mean
817801|NCT01114880|Secondary|Change From Baseline in Patient Global Assessment of Disease Activity|Participants assessed their disease activity during the preceding week using a 100 millimeter (mm) visual analog scale, with responses ranging from no activity (0) to severe activity (100).|Baseline and Week 12|ITT analysis set, missing data imputed by last observation carried forward (LOCF)||millimeters||Standard Deviation|Mean
817802|NCT01114880|Secondary|Number of Participants With ASAS Partial Remission|Participants were classified as having achieved ASAS partial remission if they had a value of less than 20 on a scale from 0 (normal/none) to 100 (most severe) in each of 4 domains: Patient's Global Assessment of Disease Activity; pain as measured by the Total Back Pain visual analog scale (VAS); function as measured by the Bath Ankylosing Spondylitis Functional Index (BASFI); and inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores).|Week 24|ITT analysis set, missing data imputed by NRI||participants|||Number
817803|NCT01114880|Secondary|Number of Participants With ASAS Partial Remission|Participants were classified as having achieved ASAS partial remission if they had a value of less than 20 on a scale from 0 (normal/none) to 100 (most severe) in each of 4 domains: Patient's Global Assessment of Disease Activity; pain as measured by the Total Back Pain visual analog scale (VAS); function as measured by the Bath Ankylosing Spondylitis Functional Index (BASFI); and inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores).|Week 12|ITT analysis set, missing data imputed by NRI||participants|||Number
817804|NCT01114880|Secondary|Number of Participants Meeting the ASAS5/6 Response Criteria|An ASAS5/6 responder had an improvement from Baseline of 20% or more in 5 of the following 6 domains: Patient's Global Assessment of Disease Activity; pain as measured by the Total Back Pain visual analog scale (VAS); function as measured by the Bath Ankylosing Spondylitis Functional Index (BASFI); inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores); spinal mobility (lateral lumbar flexion from Bath Ankylosing Spondylitis Metrology Index [BASMI]); and acute phase reactant (high-sensitivity C-reactive protein).|Week 24|ITT analysis set, missing data imputed by NRI||participants|||Number
817805|NCT01114880|Secondary|Number of Participants Meeting the ASAS5/6 Response Criteria|An ASAS5/6 responder had an improvement from Baseline of 20% or more in 5 of the following 6 domains: Patient's Global Assessment of Disease Activity; pain as measured by the Total Back Pain visual analog scale (VAS); function as measured by the Bath Ankylosing Spondylitis Functional Index (BASFI); inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores); spinal mobility (lateral lumbar flexion from Bath Ankylosing Spondylitis Metrology Index [BASMI]); and acute phase reactant (high-sensitivity C-reactive protein).|Week 12|ITT analysis set, missing data imputed by NRI||participants|||Number
817806|NCT01114880|Secondary|Number of Participants Meeting the ASAS40 Response Criteria|An ASAS40 responder had improvement of 40% or more and absolute improvement of 20 units or more (on a scale of 0 [least] to 100 [worst]) from Baseline in at least 3 of the 4 domains identified above for the ASAS20. In addition, there must have been an absence of deterioration in the potential remaining domain, where deterioration was defined as a net worsening of greater than 0 units (on a scale of 0 to 100).|Week 24|ITT analysis set, missing data imputed by NRI||participants|||Number
817807|NCT01114880|Secondary|Number of Participants Meeting the ASAS40 Response Criteria|An ASAS40 responder had improvement of 40% or more and absolute improvement of 20 units or more (on a scale of 0 [least] to 100 [worst]) from Baseline in at least 3 of the 4 domains identified above for the ASAS20. In addition, there must have been an absence of deterioration in the potential remaining domain, where deterioration was defined as a net worsening of greater than 0 units (on a scale of 0 to 100).|Week 12|ITT analysis set, missing data imputed by NRI||participants|||Number
817808|NCT01114880|Secondary|Number of Participants Meeting the ASAS20 Response Criteria|ASAS20 responder had improvement of 20% or more and absolute improvement of at least 10 units (on a scale of 0 [least] to 100 [worst]) from Baseline in at least 3 of the following 4 domains, with absence of deterioration (change for worse of at least 20% and net worsening of at least 10 units) in the potential remaining domain: Patient's Global Assessment of Disease Activity; Total Back Pain visual analog scale (VAS); Bath Ankylosing Spondylitis Functional Index (BASFI); and Inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores).|Week 24|ITT analysis set, missing data imputed by NRI||participants|||Number
817809|NCT01114880|Primary|Number of Participants Meeting the Assessment of Spondyloarthritis International Society (ASAS) ASAS20 Response Criteria|ASAS20 responder had improvement of 20% or more and absolute improvement of at least 10 units (on a scale of 0 [least] to 100 [worst]) from Baseline in at least 3 of the following 4 domains, with absence of deterioration (change for worse of at least 20% and net worsening of at least 10 units) in the potential remaining domain: Patient's Global Assessment of Disease Activity; Total Back Pain visual analog scale (VAS); Bath Ankylosing Spondylitis Functional Index (BASFI); and Inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores).|Week 12|Analysis was performed on the Intent-to-Treat (ITT) analysis set, which included all subjects who were randomized and received at least 1 dose of double-blind study drug. A non-responder (NRI) imputation was used in which a missing response was imputed as non-response.||participants|||Number
817810|NCT01114893|Secondary|IOP Change From Baseline at 8 PM on Day 5|Outcome measure shows how each treatment reducted eye pressure at 8 PM on Day 5 compared to the eye pressure at 8 PM before the start of treatment|5 Days|||mm Hg||95% Confidence Interval|Mean
817811|NCT01114893|Primary|Mean Intraocular Pressure (IOP) Change From Baseline at 8 AM on Day 5|Outcome measure shows how each treatment reduced eye pressure at 8 AM on Day 5 compared to the eye pressure at 8 AM before the start of treatment|5 days|||mm Hg||95% Confidence Interval|Mean
817812|NCT01121484|Secondary|Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Week 8|10 centimeter (cm) line (Visual Analog Scale) marked by participant. Intensity of pain range (over past week): 0 = no pain to 10 = worst possible pain. Change: score at observation minus score at baseline.|Baseline, Week 8|FAS; LOCF||cm||Standard Deviation|Mean
817813|NCT01121484|Secondary|Change From Baseline in Quick Inventory of Depressive Symptoms, 16 Question Self-report (QIDS-SR)|This is a 16-item self reported questionnaire that measures depressive symptoms. Improvement reported as change in depressive score. Score ranges from 0 to 42, with higher numbers indicating more severe symptom reporting. Change: score at observation minus score at baseline.|Baseline, Week 8|FAS; LOCF||Units on a scale||Standard Deviation|Mean
817814|NCT01121484|Secondary|Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score at Week 8|Measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Change: score at observation minus score at baseline.|Baseline, Week 8|FAS||Units on a scale||Standard Deviation|Mean
817815|NCT01121484|Secondary|Change From Baseline in Clinical Global Impression - Severity (CGI-S) at Week 8|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Change: score at observation minus score at baseline.|Baseline, Week 8|FAS; LOCF||Units on a scale||Standard Deviation|Mean
817816|NCT01121484|Secondary|Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)|CGI-I: 7-point scale in which the clinician rated how much the participant's condition has changed compared to baseline. Scores ranged from 1 (very much improved) to 7 (very much worse). Improvement defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Week 8|FAS; LOCF||participants|||Number
817817|NCT01121484|Primary|Change From Baseline in Hamilton Depression Scale (HAM-D17) at Week 8|HAM-D17, clinician-rated interview, measures presence of depressive symptoms in 17 areas (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, & weight loss). Total score ranges from 0 to 52; higher scores indicate more severe depression. Change from baseline: score at observation minus score at baseline.|Baseline, Week 8|Full Analysis Set (FAS) Population: randomized participants who had a baseline HAM-D17 score, took at least 1 dose of investigational product, and had at least 1 postbaseline HAM-D17 evaluation. Last Observation Carried Forward (LOCF).||Units on a scale||Standard Deviation|Mean
817818|NCT01121536|Primary|Change From Baseline to Endpoint in the Hamilton Anxiety Scale (HAM-A) Total Score|"HAM-A measures the severity of anxiety symptoms. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Negative change from baseline scores indicate a decrease in severity of anxiety.
Baseline was the score before the first dose of study drug in the double-blind study."|Day 0 (baseline), Month 6 or last post-baseline observation|Safety population of participants with both a baseline and post-baseline assessment.||units on a scale||Standard Deviation|Mean
817819|NCT01121536|Primary|Change From Baseline to Endpoint in the Insomnia Severity Index (ISI) Total Score|The ISI is a participant-rated, 7-item questionnaire designed to assess the severity of the participant's insomnia. Each item is ranked 0 (none) through 4 (very severe) and has a descriptor associated with each severity level. Total range is 0 (no insomnia) to 28 (very severe insomnia). Responses to each item are added to obtain a total score to determine the severity of insomnia. Negative change from baseline scores indicate a decrease in severity of insomnia. Baseline was the assessment before the first dose of study drug in the double-blind study.|Day 0 (baseline), Month 6 (or last post-baseline observation)|Safety population of treated participants with both a baseline and post-baseline assessment.||units on a scale||Standard Deviation|Mean
817820|NCT01121536|Secondary|Change From Baseline to Endpoint in the Global Assessment for Functioning (GAF) Scale|"The Global Assessment of Functioning (GAF) is a numeric scale (1 through 100) used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of adults, e.g., how well or adaptively one is meeting various problems-in-living. Ratings of 1 - 10 mean the participant is in persistent danger of severely hurting self or others (e.g., recurrent violence) or persistent inability to maintain minimal personal hygiene or serious suicidal act with clear expectation of death. Ratings of 91 - 100 indicate no symptoms, and the participant exhibits superior functioning in a wide range of activities, life's problems never seem to get out of hand, is sought out by others because of his or her many positive qualities. Positive change from baseline values indicate improvement in functioning.
Baseline was the score before the first dose of study drug in the double-blind study."|Day 0 (baseline), Month 6 or the last post-baseline assessment)|Full analysis set of participants with both a baseline and post-baseline assessment.||units on a scale||Standard Deviation|Mean
817821|NCT01121536|Secondary|Change From Baseline to Week 1 and Months 1, 2, 4, 6 and Endpoint in the Clinical Global Impression of Severity (CGI-S) for Depression|"The CGI-S is an observer-rated scale that measures illness severity on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). Negative change from baseline values indicate improvement in the severity of depression.
Baseline was the score before the first dose of study drug in the double-blind study."|Day 0 (baseline), Week 1, Months 1, 2, 4, 6 and the last post-baseline assessment)|Full analysis set||units on a scale||Standard Deviation|Mean
817822|NCT01121536|Secondary|Change From Baseline to Week 1 and Months 1, 2, 4, 6 and Endpoint in the Total Score From the 16-Item Quick Inventory of Depressive Symptomatology-Clinician-Rated (QIDS-C16)|"The QIDS-C16 was derived from specified items in the IDS-C30, clinician-rated scale to assess the severity of a participant's depressive symptoms. Total scores range from 0-27, with a score of 0 indicating no depression and a score of 27 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression.
Baseline was the score before the first dose of study drug in the double-blind study."|Day 0 (baseline), Week 1, Months 1, 2, 4, 6 and the last post-baseline assessment)|Full analysis set||units on a scale||Standard Deviation|Mean
818053|NCT01124604|Other Pre-specified|Number of Participants With Response Based on Clinical Opioid Withdrawal Symptoms Questionnaire (COWS)|COWS is an 11-item questionnaire for clinical assessment of withdrawal symptoms. Total score is calculated by adding the scores of all the 11-items. The severity of withdrawal symptoms is categorized using values of total score as: 0-4 = no withdrawal, 5-12 = mild, 13-24 = moderate, 25-36 = moderately severe, and 37-48 = severe withdrawal.|Week 12|Safety population included all the participants who received at least 1 dose of the study drug.||Participants|||Number
817823|NCT01121536|Primary|Participants With Findings During the Open-Label Study on the Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV)|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The number of participants who had findings on any of the C-SSRS-SLV (SLV=since last visit) categories at any of the time frames are indicated.
- C-SSRS=Columbia Suicide Severity Rating Scale"|Day 1, Week 1, Months 1, 2, 4 and 6 or last post-baseline visit|Safety population; only 19 participants were asked the last three questions as the inclusion of these questions depends on physician assessment.||participants|||Number
817824|NCT01121536|Primary|Change From Baseline to Endpoint in the Young Mania Rating Scale (YMRS) Total Score|"The YMRS is a clinician-rated, 11-item checklist used to measure the severity of manic episodes. Information for assigning scores is gained from the participant's subjective reported symptoms over the previous 48 hours and from clinical observation during the interview. Seven items are ranked 0 through 4 and have descriptors associated with each severity level. Four items (irritability, speech, content, and disruptive-aggressive behavior) are scored 0 through 8 and have descriptors for every second increment. The total scale is 0-60. A score of ≤12 indicates remission of manic symptoms, and higher scores indicate greater severity of mania. Negative change from baseline scores indicate a decrease in severity of mania.
Baseline was the score before the first dose of study drug in the double-blind study."|Day 0 (baseline), Month 6 or last post-baseline observation|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with both baseline (double-blind study) and treatment assessments during the open-label study.||units on a scale||Standard Deviation|Mean
817825|NCT01121536|Primary|Change From Baseline to Endpoint in Body Weight|Baseline was the score before the first dose of study drug in the double-blind study.|Day 0 (baseline), Month 6 (or last post-baseline observation)|Safety population of treated participants with both baseline and post-baseline assessments.||kg||Standard Deviation|Mean
817826|NCT01121536|Secondary|Change From Baseline to Week 1 and Months 1, 2, 4, 6 and Endpoint in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)|"The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.
Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression.
Baseline was the score before the first dose of study drug in the double-blind study."|Day 0 (baseline), Week 1, Months 1, 2, 4, 6 and the last post-baseline assessment)|Full analysis set||units on a scale||Standard Deviation|Mean
817827|NCT01121536|Primary|Physical Examination Shifts From Baseline to Endpoint|"Baseline is the day prior to double-blind treatment. Assessments are summarized as normal or abnormal. The first assessment is the baseline assessment followed by the endpoint assessment. For example 'normal/abnormal' indicates participants who were normal at baseline and abnormal at endpoint.
HEENT = Head, Eye, Ear, Nose and Throat exam"|Day 0 (baseline), Month 6 (or last post-baseline observation)|Safety population of treated participants with baseline and endpoint assessments Participants n=: General appearance 785, HEENT 784, Chest and lungs 785, Heart 785, Abdomen 785, Musculoskeletal 785, Skin 785, Lymph nodes 780, Neurological 784||participants|||Number
817828|NCT01121536|Primary|Change From Baseline to Endpoint in Electrocardiogram (ECG) Values|"ECG was conducted at baseline which was before the first dose of study drug in the double-blind study, and at the month-6 visit of the open-label study (or early termination).
RR= inter-beat intervals"|Day 0 (baseline), Month 6 or last post-baseline observation|Safety population of treated participants with both baseline and post-baseline ECG assessments||msec||Standard Deviation|Mean
817829|NCT01121536|Primary|Participants With Clinically Significant Abnormal Vital Signs Values|"Summary of vital signs tests in which at least one participant had a during study value that was clinically significant abnormal. Criterion for clinically significant abnormal vital signs are based on FDA Neuropharmacological Division criteria:
Pulse high: >=120 beats per minute (bpm) and increase of >=15 bpm from baseline
Pulse low: <=50 bpm and decrease of >=15 bpm from baseline
Sitting systolic blood pressure high: >=180 mm Hg and increase of >=20 mm Hg from baseline
Sitting systolic blood pressure low: <=90 mm Hg and decrease of >=20 mm Hg from baseline
Sitting diastolic blood pressure high: >=105 mm Hg and increase of >=15 mm Hg from baseline
Sitting diastolic blood pressure low: <=50 mm Hg and decrease of >=15 mm Hg from baseline"|Day 1 to Month 6|Safety population with post-baseline vital signs assessments||participants|||Number
817830|NCT01121536|Primary|Participants With Clinically Significant Abnormal Urinalysis Values|Summary of urinalysis tests in which at least one participant had a during study value that was clinically significant abnormal. Criterion for clinically significant abnormal urinalysis tests was >=2 unit increase from baseline.|Day 1 to Month 6|Safety population with post-baseline urinalysis assessments||participants|||Number
817831|NCT01121536|Primary|Participants With Clinically Significant Abnormal Hematology Values|"Summary of hematology tests in which at least one participant had a during study value that was clinically significant abnormal. The test name and criterion for clinically significant abnormal appear in each row.
ULN=upper limit of normal
WBC - white blood cell counts with a normal range of 3.8-10.7 10^9/L.
Hemoglobin with a normal range of 115-181 g/L
Hematocrit with a normal range of 0.34-0.54 L/L
Platelet counts with a normal range of 130-400 10^9/L
ANC= absolute neutrophil counts with a normal range of 1.96-7.23 10^9/L"|Day 1 to Month 6|Safety population with post-baseline hematology assessments||participants|||Number
817832|NCT01121536|Primary|Participants With Clinically Significant Abnormal Serum Chemistry Values|"Summary of serum chemistry tests in which at least one participant had a during study value that was clinically significant abnormal. The test name and criterion for clinically significant abnormal appear in each row.
ULN=upper limit of normal
BUN=Blood Urea Nitrogen; Uric acid has a normal range of 125-494 μmol/L. Criterion for clinically significant abnormal are different for men and women.
GGT = gamma-glutamyl transpeptidase with a normal range of 4-61 U/L
ALT = alanine aminotransferase with a normal range of 6-43 U/L
BUN = blood urea nitrogen with a normal range of 1.4-8.6 mmol/L
AST = aspartate aminotransferase with a normal range of 9-36 U/L"|Day 1 to Month 6|Safety population with post-baseline serum chemistry assessments||participants|||Number
818259|NCT01118273|Secondary|Cumulative Proportion of Participants Taking Rescue Medication by Hour|"Subjects were allowed to rescue and take a non-study pain reliever if the pain was not tolerable. This measure represents for the proportion of subjects who rescued in the study."|Up to 10 hours|ITT (Intent to Treat) Population||Participants|||Number
817833|NCT01121536|Primary|Participants With Treatment-Emergent Adverse Events (TEAE)|"AEs were graded by the investigator for severity on a three-point scale: mild, moderate and severe. Causality is graded as either related or not related. A serious adverse event (SAE) is an AE resulting in death, a life-threatening adverse event, hospitalization, a persistent or significant disability/incapacity, a congenital anomaly/birth defect, or an important medical event that may require medical intervention to prevent any of the previous results.
Protocol-defined adverse events requiring expedited reporting included skin rash, hypersensitivity reaction, emergent suicidal ideation or suicide attempt, and psychosis."|Day 1 up to Month 6|Safety population||participants|||Number
817834|NCT01121549|Secondary|Time to Disease Progression (TTP)|Time to disease progression was defined as the time from inclusion to first local or distant recurrence at any site.|Baseline up to Year 3|Time to disease progression was considered complementary to RFS and hence, was not analyzed.|||||
817835|NCT01121549|Secondary|Recurrence-free Survival (RFS)|Recurrence-free survival defined as the time from study inclusion to the first date of documented recurrence, with events defined as: local recurrence, distant recurrence, new primary breast cancer (includes both ipsilateral and contralateral second primaries), or death due to any cause. New primary cancer at sites other than the breast were not considered as recurrence.|Baseline up to Year 3|A subgroup of participants from FAS who had documented recurrence was evaluable for this measure.||weeks||Full Range|Median
817836|NCT01121549|Secondary|Percentage of Participants Who Discontinued the Exemestane Therapy||Baseline up to Year 3|Safety analysis set included all participants who had received at least 1 dose of exemestane during the observation period.||percentage of participants|||Number
817837|NCT01121549|Secondary|Number of Participants Who Received Hormonal Therapy or Chemotherapy After Discontinuation of Exemestane Therapy||Baseline up to Year 3|FAS included all participants who had received at least 1 dose of exemestane during the observation period.||participants|||Number
817838|NCT01121549|Secondary|Number of Participants With Reasons for Discontinuing Exemestane Therapy||Baseline up to Year 3|Safety analysis set included all participants who had received at least 1 dose of exemestane during the observation period.||participants|||Number
817839|NCT01121549|Secondary|Number of Missed Exemestane Doses||Week 25, 49, 73, 97, 121, 145|Full analysis set (FAS) included all participants who had received at least 1 dose of exemestane during the observation period. 'N' (number of participants analyzed)=participants evaluable for this measure. n=number of participants evaluable at specified time points. None of the participants were evaluable at Week 145 and hence data not reported.||missed doses||Standard Deviation|Mean
817840|NCT01121549|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) by Relationship to Study Drug|An AE (all causalities) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to exemestane was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.|Baseline up to 28 days after last dose|Safety analysis set included all participants who had received at least 1 dose of exemestane during the observation period.||participants|||Number
817841|NCT01121549|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) by Severity|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs were graded using National Cancer Institute (NCI)/Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events version 4.0 (CTCAE,v4.0) as Grade 1 (Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated); Grade 2 (Moderate; minimal, local or noninvasive intervention; limiting age-appropriate instrumental activities of daily living [ADL]); Grade 3 (Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization; disabling; limiting self-care ADL); Grade 4 (Life-threatening; urgent intervention indicated) and Grade 5 (Death related to AE).|Baseline up to 28 days after last dose|Safety analysis set included all participants who had received at least 1 dose of exemestane during the observation period.||participants|||Number
817842|NCT01121562|Secondary|Dose-corrected Trough Plasma Concentrations of Sunitinib, SU012662 and Total Drug (Sunitinib + SU012662).|"Reference dose is 37.5 mg. Dose-corrected concentration is calculated from the following formula, observed concentration multiplied by 37.5 over actual dose.
SU012662 is an active metabolite of sunitinib."|Predose of Cycle 1 Day15, Cycle 2 Day1, Cycle 3 Day1, and Cycle 4 Day 1|"The pharmacokinetics analysis set was defined as all participants who had at least one plasma concentration data at trough sampling with steady-state condition. n in the measured values means number of participants analyzed."||nanogram/mL||Standard Deviation|Mean
817843|NCT01121562|Secondary|Overall Survival (OS)|Overall Survival (OS) is defined as the time from registration to documentation of death due to any cause.|Up to 3 years from the last subject registration to the study|"Full Analysis Set was defined as the population of all enrolled participants in whom well-differentiated pancreatic neuroendocrine tumor had been diagnosed and who received at least one dose of study medication.
OS was not analyzed due to short of events."||Months||95% Confidence Interval|Median
817844|NCT01121562|Secondary|Progression-free Survival (PFS)|PFS is defined as the time from registration to first documentation of progressive disease (PD) or to death due to any cause, whichever occurs first.|Up to 799 days of treatment|"Full Analysis Set was defined as the population of all enrolled participants in whom well-differentiated pancreatic neuroendocrine tumor had been diagnosed and who received at least one dose of study medication.
Median PFS had not yet been reached due to short of events."||Months||95% Confidence Interval|Median
817845|NCT01121562|Secondary|Tumor Shrinkage|Tumor shrinkage is defined as the percent change from baseline for the sum of the longest diameter of target lesions in participants.|Up to 799 days of treatment|"Full Analysis Set was defined as the population of all enrolled participants in whom well-differentiated pancreatic neuroendocrine tumor had been diagnosed and who received at least one dose of study medication. n  in the measured values means number of participants analyzed in the cycle."||percent change||Standard Deviation|Mean
817846|NCT01121562|Secondary|Objective Response Rate (ORR)|ORR is defined as the percentage of participants with a best overall response of confirmed CR or confirmed PR. Based on the response evaluation criteria in solid tumors (RECIST), CR is defined as the disappearance of all target lesions and PR is defined as a greater than or equal to 30% decrease in the sum of the longest dimensions of the target lesion.|Up to 799 days of treatment|Full Analysis Set was defined as the population of all enrolled participants in whom well-differentiated pancreatic neuroendocrine tumor had been diagnosed and who received at least one dose of study medication.||percentage of participants||95% Confidence Interval|Number
817847|NCT01121562|Primary|Clinical Benefit Response Rate (CBR)|"CBR rate is defined as the percentage of participants with a best overall response of confirmed complete response (CR), confirmed partial response (PR) ,or stable disease (SD) ≥ 24 weeks.
Based on RECIST, CR is defined as the disappearance of all target lesions and PR is defined as a greater than or equal to 30% decrease in the sum of the longest dimensions of the target lesion. SD is defined neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest dimensions since the treatment started."|Up to 799 days of treatment|Full Analysis Set was defined as the population of all enrolled participants in whom well-differentiated pancreatic neuroendocrine tumor had been diagnosed and who received at least one dose of study medication.||percentage of participants||95% Confidence Interval|Number
817848|NCT01121575|Secondary|Plasma Dacomitinib and PF-05199265 Pharmacokinetic Parameter in Expansion Cohort 2 With or Without Co-administration of Dacomitinib - Tmax|PK samples for full PK evaluation of dacomitinib were drawn on Day -1 (one day before C1D1 on which the combination treatment of crizotinib and dacomitinib started) and on C2D1. Dacomitinib and PF-05199265 PK parameter (Tmax) following dacomitinib alone and in combination with crizotinib are summarized in the below table. Tmax was observed directly from data as time of first occurrence.|Day -1 (dacomitinib alone), C2D1 (crizotinib + dacomitinib)|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.||Hour||Full Range|Median
817849|NCT01121575|Secondary|Plasma Dacomitinib and PF-05199265 Pharmacokinetic Parameter in Expansion Cohort 2 With or Without Co-administration of Dacomitinib - Tlast|PK samples for full PK evaluation of dacomitinib were drawn on Day -1 (one day before C1D1 on which the combination treatment of crizotinib and dacomitinib started) and on C2D1. Dacomitinib and PF-05199265 PK parameter (Tlast) following dacomitinib alone and in combination with crizotinib are summarized in the below table. Tlast was observed directly from data.|Day -1 (dacomitinib alone), C2D1 (crizotinib + dacomitinib)|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.||Hour||Full Range|Median
817850|NCT01121575|Secondary|Plasma Dacomitinib and PF-05199265 Pharmacokinetic Parameter in Expansion Cohort 2 With or Without Co-administration of Dacomitinib - Cmax|PK samples for full PK evaluation of dacomitinib were drawn on Day -1 (one day before C1D1 on which the combination treatment of crizotinib and dacomitinib started) and on C2D1. Dacomitinib and PF-05199265 PK parameter (Cmax) following dacomitinib alone and in combination with crizotinib are summarized in the below table. Cmax was observed directly from data.|Day -1 (dacomitinib alone), C2D1 (crizotinib + dacomitinib)|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
817851|NCT01121575|Secondary|Plasma Dacomitinib and PF-05199265 Pharmacokinetic Parameter in Expansion Cohort 2 With or Without Co-administration of Dacomitinib - Cmin|PK samples for full PK evaluation of dacomitinib were drawn on Day -1 (one day before C1D1 on which the combination treatment of crizotinib and dacomitinib started) and on C2D1. Dacomitinib and PF-05199265 PK parameter (Cmin) following dacomitinib alone and in combination with crizotinib are summarized in the below table. Cmin was observed directly from data.|Day -1 (dacomitinib alone), C2D1 (crizotinib + dacomitinib)|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
817852|NCT01121575|Secondary|Plasma Dacomitinib and PF-05199265 Pharmacokinetic Parameter in Expansion Cohort 2 With or Without Co-administration of Dacomitinib - AUC24|PK samples for full PK evaluation of dacomitinib were drawn on Day -1 (one day before C1D1 on which the combination treatment of crizotinib and dacomitinib started) and on C2D1. Dacomitinib and PF-05199265 PK parameter (AUC24) following dacomitinib alone and in combination with crizotinib are summarized in the below table. AUC24 was calculated using Linear/Log trapezoidal method.|Day -1 (dacomitinib alone), C2D1 (crizotinib + dacomitinib)|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.||ng•hr/mL||Geometric Coefficient of Variation|Geometric Mean
817853|NCT01121575|Secondary|Plasma Dacomitinib and PF-05199265 Pharmacokinetic Parameter in Expansion Cohort 2 With or Without Co-administration of Dacomitinib - AUClast|PK samples for full PK evaluation of dacomitinib were drawn on Day -1 (one day before C1D1 on which the combination treatment of crizotinib and dacomitinib started) and on C2D1. Dacomitinib and PF-05199265 PK parameter (AUClast) following dacomitinib alone and in combination with crizotinib are summarized in the below table. AUClast was calculated using Linear/Log trapezoidal method.|Day -1 (dacomitinib alone), C2D1 (crizotinib + dacomitinib)|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.||ng•hr/mL||Geometric Coefficient of Variation|Geometric Mean
818260|NCT01118273|Secondary|Time to Rescue Medication|"Subjects were allowed to rescue and take a non-study pain reliever if the pain was not tolerable. This measure represents for the time to taking rescue medication from the time the subject took study treatment."|Up to 10 hours|ITT (Intent to Treat) Population||Minutes||95% Confidence Interval|Median
817854|NCT01121575|Secondary|Plasma Crizotinib and PF-06260182 Pharmacokinetic Parameter in Expansion Cohort 1 With or Without Co-administration of Dacomitinib - Tmax|Participants were evaluated for the effect of dacomitinib on steady-state PK of crizotinib. PK of crizotinib alone was evaluated on Day -1 (one day before C1D1 on which the combination treatment of crizotinib and dacomitinib started) after a lead in period of continuous BID dosing of crizotinib for approximately 12 days (±2 days). PK of crizotinib and dacomitinib in combination treatment was evaluated on Day 1 of Cycle 2. Blood samples for crizotinib full PK were to be collected on Day -1 and Day 1 of Cycle 2. The below table included PK data for Tmax. Tmax was observed directly from data as time of first occurrence.|Day -1 (crizotinib alone), C2D1 (crizotinib + dacomitinib)|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.||Hour||Full Range|Median
817855|NCT01121575|Secondary|Plasma Crizotinib and PF-06260182 Pharmacokinetic Parameter in Expansion Cohort 1 With or Without Co-administration of Dacomitinib - Tlast|Participants were evaluated for the effect of dacomitinib on steady-state PK of crizotinib. PK of crizotinib alone was evaluated on Day -1 (one day before C1D1 on which the combination treatment of crizotinib and dacomitinib started) after a lead in period of continuous BID dosing of crizotinib for approximately 12 days (±2 days). PK of crizotinib and dacomitinib in combination treatment was evaluated on Day 1 of Cycle 2. Blood samples for crizotinib full PK were to be collected on Day -1 and Day 1 of Cycle 2. The below table included PK data for Tlast. Tlast was observed directly from data.|Day -1 (crizotinib alone), C2D1 (crizotinib + dacomitinib)|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.||Hour||Full Range|Median
817856|NCT01121575|Secondary|Plasma Crizotinib and PF-06260182 Pharmacokinetic Parameter in Expansion Cohort 1 With or Without Co-administration of Dacomitinib - Cmax|Participants were evaluated for the effect of dacomitinib on steady-state PK of crizotinib. PK of crizotinib alone was evaluated on Day -1 (one day before C1D1 on which the combination treatment of crizotinib and dacomitinib started) after a lead in period of continuous BID dosing of crizotinib for approximately 12 days (±2 days). PK of crizotinib and dacomitinib in combination treatment was evaluated on Day 1 of Cycle 2. Blood samples for crizotinib full PK were to be collected on Day -1 and Day 1 of Cycle 2. The below table included PK data for Cmax. Cmax was observed directly from data.|Day -1 (crizotinib alone), C2D1 (crizotinib + dacomitinib)|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
817857|NCT01121575|Secondary|Plasma Crizotinib and PF-06260182 Pharmacokinetic Parameter in Expansion Cohort 1 With or Without Co-administration of Dacomitinib - Cmin|Participants were evaluated for the effect of dacomitinib on steady-state PK of crizotinib. PK of crizotinib alone was evaluated on Day -1 (one day before C1D1 on which the combination treatment of crizotinib and dacomitinib started) after a lead in period of continuous BID dosing of crizotinib for approximately 12 days (±2 days). PK of crizotinib and dacomitinib in combination treatment was evaluated on Day 1 of Cycle 2. Blood samples for crizotinib full PK were to be collected on Day -1 and Day 1 of Cycle 2. The below table included PK data for Cmin. Cmin was observed directly from data.|Day -1 (crizotinib alone), C2D1 (crizotinib + dacomitinib)|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
817858|NCT01121575|Secondary|Plasma Crizotinib and PF-06260182 Pharmacokinetic Parameter in Expansion Cohort 1 With or Without Co-administration of Dacomitinib - AUC10|Participants were evaluated for the effect of dacomitinib on steady-state PK of crizotinib. PK of crizotinib alone was evaluated on Day -1 (one day before C1D1 on which the combination treatment of crizotinib and dacomitinib started) after a lead in period of continuous BID dosing of crizotinib for approximately 12 days (±2 days). PK of crizotinib and dacomitinib in combination treatment was evaluated on Day 1 of Cycle 2. Blood samples for crizotinib full PK were to be collected on Day -1 and Day 1 of Cycle 2. The below table included PK data for AUC10. AUC10 was calculated using Linear/Log trapezoidal method.|Day -1 (crizotinib alone), C2D1 (crizotinib + dacomitinib)|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.||ng•hr/mL||Geometric Coefficient of Variation|Geometric Mean
817859|NCT01121575|Secondary|Plasma Crizotinib and PF-06260182 Pharmacokinetic Parameter in Expansion Cohort 1 With or Without Co-administration of Dacomitinib - AUClast|Participants were evaluated for the effect of dacomitinib on steady-state PK of crizotinib. PK of crizotinib alone was evaluated on Day -1 (one day before C1D1 on which the combination treatment of crizotinib and dacomitinib started) after a lead in period of continuous BID dosing of crizotinib for approximately 12 days (±2 days). PK of crizotinib and dacomitinib in combination treatment was evaluated on Day 1 of Cycle 2. Blood samples for crizotinib full PK were to be collected on Day -1 and Day 1 of Cycle 2. The below table included PK data for AUClast. AUClast was calculated using Linear/Log trapezoidal method.|Day -1 (crizotinib alone), C2D1 (crizotinib + dacomitinib)|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.||ng•hr/mL||Geometric Coefficient of Variation|Geometric Mean
817879|NCT01121575|Secondary|Progression Free Survival (PFS) in Escalation Phase|PFS was defined as the time from the date of the first dose to the date of the first documentation of objective tumor progression according to RECIST 1.1 or death on study due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used.|From randomization to objective tumor progression or death (up to post treatment follow-up as 28-35 days after last dose of study treatment)|The safety analysis population included all enrolled participants who had received at least 1 dose of study medication.||Months||95% Confidence Interval|Median
817860|NCT01121575|Secondary|Plasma Dacomitinib and PF-05199265 Pharmacokinetic Parameter in Escalation Phase - Tmax|At each designated time point, blood samples (3 mL) for PK analysis of dacomitinib and its metabolite, PF 05199265 were collected in appropriately labeled collection tubes containing dipotassium ethylenediamine tetra-acetic acid (K2EDTA). The below analysis table included Tmax for dacomitinib and PF-05199265. Tmax was observed directly from data as time of first occurrence.|C1D1, C1D15|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.||Hour||Full Range|Median
817861|NCT01121575|Secondary|Plasma Dacomitinib and PF-05199265 Pharmacokinetic Parameter in Escalation Phase - Tlast|At each designated time point, blood samples (3 mL) for PK analysis of dacomitinib and its metabolite, PF 05199265 were collected in appropriately labeled collection tubes containing dipotassium ethylenediamine tetra-acetic acid (K2EDTA). The below analysis table included Tlast for dacomitinib and PF-05199265. Tlast was observed directly from data.|C1D1, C1D15|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.||Hour||Full Range|Median
817862|NCT01121575|Secondary|Plasma Dacomitinib and PF-05199265 Pharmacokinetic Parameter in Escalation Phase - Cmax|At each designated time point, blood samples (3 mL) for PK analysis of dacomitinib and its metabolite, PF 05199265 were collected in appropriately labeled collection tubes containing dipotassium ethylenediamine tetra-acetic acid (K2EDTA). The below analysis table included Cmax for dacomitinib and PF-05199265. Cmax was observed directly from data.|C1D1, C1D15|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
817863|NCT01121575|Secondary|Plasma Dacomitinib and PF-05199265 Pharmacokinetic Parameter in Escalation Phase - AUC24|At each designated time point, blood samples (3 mL) for PK analysis of dacomitinib and its metabolite, PF 05199265 were collected in appropriately labeled collection tubes containing dipotassium ethylenediamine tetra-acetic acid (K2EDTA). The below analysis table included AUC24 for dacomitinib and PF-05199265. AUC24 was calculated using Linear/Log trapezoidal method.|C1D1, C1D15|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.||ng•hr/mL||Geometric Coefficient of Variation|Geometric Mean
817864|NCT01121575|Secondary|Plasma Dacomitinib and PF-05199265 Pharmacokinetic Parameter in Escalation Phase - AUClast|At each designated time point, blood samples (3 mL) for PK analysis of dacomitinib and its metabolite, PF 05199265 were collected in appropriately labeled collection tubes containing dipotassium ethylenediamine tetra-acetic acid (K2EDTA). The below analysis table included AUClast for dacomitinib and PF-05199265. AUClast was calculated using Linear/Log trapezoidal method.|C1D1, C1D15|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.||ng•hr/mL||Geometric Coefficient of Variation|Geometric Mean
817865|NCT01121575|Secondary|Plasma Crizotinib and PF-06260182 Pharmacokinetic Parameter in Escalation Phase -Time to Maximum Plasma Concentration (Tmax)|At each designated time point, blood samples (3 mL) for pharmacokinetic (PK) analysis of crizotinib and its metabolite, PF 06260182 were collected in appropriately labeled collection tubes containing dipotassium ethylenediamine tetra-acetic acid (K2EDTA). The below analysis table included Tmax for crizotinib and PF-06260182. Tmax was observed directly from data as time of first occurrence.|C1D1, C1D15|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.||Hour||Full Range|Median
817866|NCT01121575|Secondary|Plasma Crizotinib and PF-06260182 Pharmacokinetic Parameter in Escalation Phase - Time of Last Quantifiable Concentration (Tlast)|At each designated time point, blood samples (3 mL) for pharmacokinetic (PK) analysis of crizotinib and its metabolite, PF 06260182 were collected in appropriately labeled collection tubes containing dipotassium ethylenediamine tetra-acetic acid (K2EDTA). The below analysis table included Tlast for crizotinib and PF-06260182. Tlast was observed directly from data.|C1D1, C1D15|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.||Hour||Full Range|Median
817867|NCT01121575|Secondary|Plasma Crizotinib and PF-06260182 Pharmacokinetic Parameter in Escalation Phase - Maximum Plasma Concentration (Cmax)|At each designated time point, blood samples (3 mL) for pharmacokinetic (PK) analysis of crizotinib and its metabolite, PF 06260182 were collected in appropriately labeled collection tubes containing dipotassium ethylenediamine tetra-acetic acid (K2EDTA). The below analysis table included Cmax for crizotinib and PF-06260182. Cmax was observed directly from data.|C1D1, C1D15|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
817880|NCT01121575|Secondary|Duration of Response for the Only Participant Shown Partial Response in Expansion Phase|This outcome measure presented the duration of response for one participant in expansion cohort 1 who showed partial response.|From objective response to date of progression or death due to any cause, whichever occurs first (up to post treatment follow-up as 28-35 days after last dose of study treatment)|This Outcome Measure was only assessed for participants with response.||Weeks|||Number
818261|NCT01118273|Secondary|Overall Rating of Pain Relief|"Subjects responded to question, Overall, the relief from my starting pain was by checking one of the following choices: no relief (0), a little relief (1), some relief (2), a lot of relief (3), complete relief (4)."|Up to 10 hours|ITT (Intent to Treat) Population||Participants|||Number
817868|NCT01121575|Secondary|Plasma Crizotinib and PF-06260182 Pharmacokinetic Parameter in Escalation Phase - Area Under the Plasma Concentration-time Curve 10 (AUC10)|At each designated time point, blood samples (3 mL) for pharmacokinetic (PK) analysis of crizotinib and its metabolite, PF 06260182 were collected in appropriately labeled collection tubes containing dipotassium ethylenediamine tetra-acetic acid (K2EDTA). AUC10 was calculated using Linear/Log trapezoidal method. The below analysis table included geometric Mean and Geometric Coefficient of Variation of AUC10 for crizotinib and PF-06260182. Arithmetic mean was presented if the n=2.|C1D1, C1D15|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.||ng•hr/mL||Geometric Coefficient of Variation|Geometric Mean
817869|NCT01121575|Secondary|Plasma Crizotinib and PF-06260182 Pharmacokinetic Parameter in Escalation Phase - Area Under the Plasma Concentration-time Profile From Time Zero to the Last Quantifiable Concentration (AUClast)|At each designated time point, blood samples (3 mL) for pharmacokinetic (PK) analysis of crizotinib and its metabolite, PF 06260182 were collected in appropriately labeled collection tubes containing dipotassium ethylenediamine tetra-acetic acid (K2EDTA). The below analysis table included AUClast for crizotinib and PF-06260182. AUClast was calculated using Linear/Log trapezoidal method.|Cycle 1 (C1)/Day 1 (D1), C1D15|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.||ng•hr/mL||Geometric Coefficient of Variation|Geometric Mean
817870|NCT01121575|Secondary|Number of Participants With ROS1 Gene Translocation at Baseline|Sample analyses were performed in accordance to GLP guidance and included translocation detection (RNA based) for ROS1 gene.|Baseline|The tumor analysis population included participants in safety analysis population who had a screening and on-treatment tumor biopsy for assessment of tumor biomarkers. However, number of participants analyzed in the below table included the participants evaluated for ROS1 gene translocation.||Participants|||Number
817871|NCT01121575|Secondary|Number of Participants With PIK3CA Mutation at Baseline|Sample analyses were performed in accordance to GLP guidance and included mutation detection for PIK3CA gene.|Baseline|The tumor analysis population included participants in safety analysis population who had a screening and on-treatment tumor biopsy for assessment of tumor biomarkers.||Participants|||Number
817872|NCT01121575|Secondary|Number of Participants With KRAS Mutation (GLY12CYS) at Baseline|Sample analyses were performed in accordance to GLP guidance and included mutation detection for KRAS gene.|Baseline|The tumor analysis population included participants in safety analysis population who had a screening and on-treatment tumor biopsy for assessment of tumor biomarkers.||Participants|||Number
817873|NCT01121575|Secondary|Number of Participants With EGFR Mutation at Baseline|Sample analyses were performed in accordance to Good Laboratory Practice (GLP) guidance and included mutation detection for EGFR gene.|Baseline|The tumor analysis population included participants in safety analysis population who had a screening and on-treatment tumor biopsy for assessment of tumor biomarkers.||Participants|||Number
817874|NCT01121575|Secondary|Plasma Concentration of sMet by Study Visits|This outcome measure presented the plasma concentration of sMet at different study visits. s-Met was analyzed using an enzyme-linked immunosorbent assay (ELISA).|At screening and Cycle 1 Day 1 (C1D1) (6 hours post dose), and C1D15, C2D1, C2D15 (all predose).|The soluble protein analysis population included participants in safety analysis who had a screening or C1D1 soluble protein assessment, and at least one on-treatment soluble protein assessment (C1D14 C2D1 or C2D14).||pg/mL||Standard Deviation|Mean
817875|NCT01121575|Secondary|Number of Participants With c-Met, HER2, EGFR Amplification and ALK Rearrangement at Baseline Using FISH Method|Participants showed amplification of c-Met, HER2, and EGFR in the tumor cells and gene rearrangement of ALK are presented in this outcome measure.|Baseline|The tumor analysis population included participants in safety analysis population who had a screening and on-treatment tumor biopsy for assessment of tumor biomarkers.||Participants|||Number
817876|NCT01121575|Secondary|Expression Analysis of Tumor Biomarkers (EGFR, and c-Met) at Baseline Using Fluorescent in Situ Hybridization (FISH) Method|Expression of tumor biomarkers EGFR and cMet at Baseline (using FISH method) are presented in this outcome measure.|Baseline|The tumor analysis population included participants in safety analysis population who had a screening and on-treatment tumor biopsy for assessment of tumor biomarkers.||Ratio||Full Range|Median
817877|NCT01121575|Secondary|Expression Analysis of Tumor Biomarkers (HGF, EGFR, and c-Met ) at Baseline Using Immunohistochemistry (IHC) Method|Tumor biomarkers such as HGF, EGFR, and c-Met were analyzed in tumor cells (neoplastic compartment) of tumor specimens from both expansion cohorts 1 and 2 by IHC. The H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+, where 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum calculated score of 0 to maximum calculated score of 300, where 0 correspond to no expression and maximum score of 300 indicates the strongest expression. However, the biomarker expression level (higher or lower) was not a predictor of outcome.|Baseline|The tumor analysis population included participants in safety analysis population who had a screening and on-treatment tumor biopsy for assessment of tumor biomarkers.||H-Score||Full Range|Median
817878|NCT01121575|Secondary|Progression Free Survival (PFS) in Expansion Phase|PFS was defined as the time from the date of the first dose to the date of the first documentation of objective tumor progression according to RECIST 1.1 or death on study due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used.|From randomization to objective tumor progression or death (up to post treatment follow-up as 28-35 days after last dose of study treatment)|The safety analysis population included all enrolled participants who had received at least 1 dose of study medication. In Expansion Cohort 1, two participants had censored reasons of “no adequate baseline”, of which one participant had a censored reason “no tumor assessment data available.||Months||95% Confidence Interval|Median
817904|NCT01121666|Secondary|Number of Days of r-hFSH Stimulation|Mean duration of stimulation was assessed.|At the day of hCG administration, up to 16 days|All participants were analyzed.||days||Standard Deviation|Mean
817905|NCT01121666|Secondary|Number of Participants With Cryopreserved 2PNs, Embryos/Blastocysts||Day 1, 2, 3 and 5 of OPU/fertilisation|Intention to treat population||Patients with cryopreservation|||Number
817881|NCT01121575|Secondary|Number of Participants With ORR in Expansion Phase|ORR was defined as the percent of participants with CR or PR according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) determined by study physicians, relative to the response evaluable population. Participants were considered non-responders until proven otherwise. Thus, participants who: 1) Did not have CR or PR while on study, or 2) Did not have a post-baseline tumor evaluation, or 3) Received anti-tumor treatment other than the study medication prior to reaching a CR or PR, or 4) Died, in progress, or drop out for any reason prior to reaching a CR or PR, were counted as non-responders in the assessment of ORR. To be assigned a status of PR or CR, changes in tumor measurements in participants with responding tumors were confirmed by repeated tumor assessment that were performed 4 weeks after the criteria for response were first met.|From objective response to date of progression or death due to any cause, whichever occurs first (up to post treatment follow-up as 28-35 days after last dose of study treatment)|The response evaluable population included participants in safety analysis population who had an adequate Baseline tumor assessment.||Participants||95% Confidence Interval|Number
817882|NCT01121575|Secondary|Number of Participants With Objective Response Rate (ORR) in Escalation Phase|ORR was defined as the percent of participants with CR or PR according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) determined by study physicians, relative to the response evaluable population. Participants were considered non-responders until proven otherwise. Thus, participants who: 1) Did not have CR or PR while on study, or 2) Did not have a post-baseline tumor evaluation, or 3) Received anti-tumor treatment other than the study medication prior to reaching a CR or PR, or 4) Died, in progress, or drop out for any reason prior to reaching a CR or PR, were counted as non-responders in the assessment of ORR. To be assigned a status of PR or CR, changes in tumor measurements in participants with responding tumors were confirmed by repeated tumor assessment that were performed 4 weeks after the criteria for response were first met.|From objective response to date of progression or death due to any cause, whichever occurs first (up to post treatment follow-up as 28-35 days after last dose of study treatment)|The response evaluable population included participants in safety analysis population who had an adequate Baseline tumor assessment.||Participants||95% Confidence Interval|Number
817883|NCT01121575|Secondary|Number of Participants With Stable Disease and Stable Disease Duration in Expansion Phase|If a participant had not achieved an objective response with confirmed complete response (CR) or partial response (PR) according to RECIST (1.1) as determined by the investigators, relative to the response evaluable population, but remained stable for at least 6 weeks after first dose, then the best overall response for such a participant was considered as stable disease.|From objective response to date of progression or death due to any cause, whichever occurs first (up to post treatment follow-up as 28-35 days after last dose of study treatment)|The response evaluable population included participants in safety analysis population who had an adequate Baseline tumor assessment.||Participants|||Number
817884|NCT01121575|Secondary|Number of Participants With Stable Disease and Stable Disease Duration in Escalation Phase|If a participant had not achieved an objective response with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) - 1.1 as determined by the investigators, relative to the response evaluable population, but remained stable for at least 6 weeks after first dose, then the best overall response for such a participant was considered as stable disease.|From objective response to date of progression or death due to any cause, whichever occurs first (up to post treatment follow-up as 28-35 days after last dose of study treatment)|The response evaluable population included participants in safety analysis population who had an adequate Baseline tumor assessment.||Participants|||Number
817885|NCT01121575|Primary|Number of Participants With Dose Limiting Toxicities (DLTs) in Escalation Phase|DLTs were those AEs which occurred in Cycle 1 of treatment in Dose Escalation Phase which may be attributed to study drug [combined Crizotinib (PF-02341066) plus Dacomitinib (PF-00299804)] without a clear alternative explanation and despite the use of adequate/maximal medical intervention as dictated by local institutional clinical practices or the judgment of the investigator. The following events were considered DLTs (using CTCAE version 4.02);1. Grade ≥4 hematologic events. 2. Grade ≥3 non-hematological events (except Grade 3/4 asymptomatic hypophosphatemia and Grade 3/4 hyperuricemia without signs and symptoms of gout). Nausea, vomiting or diarrhea had to have persisted at Grade 3 or 4 despite maximal medical therapy. Grade 3 hypertension will be considered a DLT only if the event is unmanageable by standard approved pharmacologic agents or if the symptomatic sequelae are identified despite appropriate medical intervention.|Cycle 1 (4 weeks)|The DLT evaluable population was defined as safety analysis (SA) participants in the Dose Escalation phase who did not have a major treatment deviation during the first cycle.||Participants|||Number
817886|NCT01121575|Primary|Overview of Treatment-emergent, Treatment-related AEs in Expansion Phase|An AE was any untoward medical occurrence attributed to study treatment in a participant who received study treatment. SAE was an AE resulting in death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, congenital anomaly. Treatment-emergent AEs were those with initial onset or that worsen in severity after the first dose of study medication. AEs were reported from signing of informed consent until 28 days after the last dose of study medication. SAEs were reported after this time frame if considered to be treatment related. The severity of AEs were graded by the investigator using NCI CTCAE v.4.02 and was assessed as Grade 0: no change from normal or reference range; Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: life-threatening or disabling; Grade 5: death related to AE. However the below table included Grade 3, 4, and 5 AEs.|Up to Maximum of treatment duration + 28 days for each participant (could be 295 days)|The safety analysis population included all enrolled participants who had received at least 1 dose of study medication.||Participants|||Number
817906|NCT01121666|Secondary|Embryo Quality: Mean Number of Blastomeres|"Main embryo quality parameter mean number of blastomeres"|Day 2 of OPU/fertilisation|Intention to treat population||Number of blastomeres at day 3||Standard Deviation|Mean
817907|NCT01121666|Secondary|Fertilisation Rate of Oocytes|Fertilisation rate was assessed|1 day after ovum pick-up|Intention to treat population||percentage of oocytes||Standard Deviation|Mean
817908|NCT01121666|Secondary|Quality of Oocytes Retrieved|Number of patients with ovum pick-up|34-36 hours after hCG administration|Intention to treat population||Participants|||Number
817909|NCT01121666|Secondary|Total Dose of r-hFSH Administered|Total dose of r-hFSH required was assessed.|Day of hCG administration (after maximum 16 days of r-hFSH treatment)|All participants were analyzed.||IU||Standard Deviation|Mean
817887|NCT01121575|Primary|Overview of Treatment-emergent, Treatment-related AEs in Escalation Phase|An AE was any untoward medical occurrence attributed to study treatment in a participant who received study treatment. SAE was an AE resulting in death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, congenital anomaly. Treatment-emergent AEs were those with initial onset or that worsen in severity after the first dose of study medication. AEs were reported from signing of informed consent until 28 days after the last dose of study medication. SAEs were reported after this time frame if considered to be treatment related. The severity of AEs were graded by the investigator using NCI CTCAE v.4.02 and was assessed as Grade 0: no change from normal or reference range; Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: life-threatening or disabling; Grade 5: death related to AE. However the below table included Grade 3, 4, and 5 AEs.|Up to Maximum of treatment duration + 28 days for each participant (could be 295 days)|The safety analysis population included all enrolled participants who had received at least 1 dose of study medication.||participants|||Number
817888|NCT01121575|Primary|Overview of Treatment-emergent All Causalities AEs in Expansion Phase|AE was any untoward medical occurrence with study drug/ device in a trial participant. SAE was an AE resulting in death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, congenital anomaly. Treatment-emergent AEs were those with initial onset or that worsen in severity after the first dose of study medication. AEs were reported from signing of informed consent until 28 days after the last dose of study medication. SAEs were reported after this time frame if considered to be treatment related. The severity of AEs were graded by the investigator using NCI CTCAE v.4.02 and was assessed as Grade 0: no change from normal or reference range; Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: life-threatening or disabling; Grade 5: death related to AE. However the below table included Grade 3, 4, and 5 AEs.|Up to Maximum of treatment duration + 28 days for each participant (could be 295 days)|The safety analysis population included all enrolled participants who had received at least 1 dose of study medication.||Participants|||Number
817889|NCT01121575|Primary|Overview of Treatment-emergent All Causalities Adverse Events (AEs) in Escalation Phase|AE was any untoward medical occurrence with study drug/ device in a trial participant. Serious adverse event (SAE) was an AE resulting in death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, congenital anomaly. Treatment-emergent AEs were those with initial onset or that worsen in severity after the first dose of study medication. AEs were reported from signing of informed consent until 28 days after the last dose of study medication. SAEs were reported after this time frame if considered to be treatment related. The severity of AEs were graded by the investigator using National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) v.4.02 and was assessed as Grade 0: no change from normal or reference range; Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: life-threatening or disabling; Grade 5: death related to AE. However the below table included Grade 3, 4, and 5 AEs.|Up to Maximum of treatment duration + 28 days for each participant (could be 295 days)|The safety analysis population included all enrolled participants who had received at least 1 dose of study medication.||participants|||Number
817890|NCT01121666|Secondary|Quality of Oocytes Retrieved|The nuclear maturity was assessed (Germinal vesicle, Metaphase I, Metaphase II).|After oocyte retrieval, 34 to 36 hours after hCG administration|Intention to treat population||Percentage of cells|||Number
817891|NCT01121666|Secondary|Quality of Oocytes Retrieved|The maturity of the cumulus oophorus was assessed.|After oocyte retrieval, 34 to 36 hours after hCG administration|Intention to treat population||Percentage of cumulus oophori|||Number
817892|NCT01121666|Secondary|Ongoing Pregnancy (Second Treatment Cycle)|Ongoing pregnancy per embryo transfer. Presence of at least one viable fetus 10 weeks after embryo transfer.|10 weeks after embryo transfer|Population with a second treatment cycle||Ongoing pregnancies|||Number
817893|NCT01121666|Secondary|Clinical Pregnancy Rate (Second Treatment Cycle)|Presence of at least one intrauterine gestational sac.|Five to six weeks after oocyte retrieval|Population with a second treatment cycle||Clinical pregnancies|||Number
817894|NCT01121666|Secondary|Quality of Oocytes Retrieved|Number of embryos per blastocysts transferred|Day of embryo transfer, either 2, 3 or 5 days after oocyte retrieval|Intention to treat population||embryos per blastocysts transferred||Standard Deviation|Mean
817895|NCT01121666|Secondary|Quality of Oocytes Retrieved|Number of patients with transferred blastocysts|At day 4 and 5|Intention to treat population||Participants|||Number
817896|NCT01121666|Secondary|Embryo Quality: Absence of Multinucleation|"Main embryo quality parameter absence of multinucleation observed."|Day 3|Intention to treat population||Percentage of absent multinucleation|||Number
817897|NCT01121666|Primary|Number of Oocytes Retrieved (Intention-to-treat Population)|"As soon as ovulation criteria were reached, HCG was given to trigger ovulation and 34-36 hours later, oocytes were retrieved. If criteria for ovulation triggering could not be reached by FSH stimulation on day 16, treatment was to be stopped.
The equivalence in the number of retrieved oocytes was tested using a pre-determined clinical equivalence margin of +/- 2.9 oocytes"|34-36 hours after hCG administration and after maximum 16 days of r-hFSH treatment|Intention-to-treat population||Number of retrieved oocytes||Standard Deviation|Mean
817898|NCT01121666|Secondary|Live Birth Rate|Patients with liveborn children|After childbirth with questionnaire|Intention to treat population||Patients with liveborn children|||Number
817899|NCT01121666|Secondary|Ongoing Pregnancy|Ongoing pregnancy per embryo transfer. Presence of at least one viable fetus 10 weeks after embryo transfer.|Ten weeks after embryo transfer|Intention to treat population||Ongoing pregnancies|||Number
817900|NCT01121666|Secondary|Clinical Pregnancy Rate|Presence of at least one intrauterine gestational sac.|Five to six weeks after oocyte retrieval|Intention to treat population||Clinical pregnancies|||Number
817901|NCT01121666|Secondary|Implantation Rate|Defined as fetal sac per embryo transferred.|Five to six weeks after oocyte retrieval|Intention to treat population.||Percentage of implantations|||Number
817902|NCT01121666|Secondary|Number of Patients With Good Response|"Good response was defined as patients with an oocyte retrieval of four or more oocytes"|Until child birth/miscarriage, up to the end of the study|Intention to treat population.||Participants|||Number
817903|NCT01121666|Secondary|Number of Patients With Cycle Cancellation|Number of patients with cycle cancellation was assessed.|Until child birth/miscarriage, up to the end of the study|Intention to treat population||Number of patients|||Number
817912|NCT01121666|Primary|Number of Oocytes Retrieved (Per Protocol Population)|"As soon as ovulation criteria were reached, HCG was given to trigger ovulation and 34-36 hours later, oocytes were retrieved. If criteria for ovulation triggering could not be reached by FSH stimulation on day 16, treatment was to be stopped.
The equivalence in the number of retrieved oocytes was tested using a pre-determined clinical equivalence margin of +/- 2.9 oocytes"|34-36 hours after hCG administration and after maximum 16 days of r-hFSH treatment|Per protocol population||Number of retrieved oocytes||Standard Deviation|Mean
817913|NCT01121757|Other Pre-specified|Serum Markers Measured on the First Day of Cycle 1 and on the First Day of Cycle 3||Within 4 months of taking single agent and 6 months of taking the combination||||||
817914|NCT01121757|Secondary|Number of Participants With Grade 3 and 4 Toxicities|Evaluate the safety of lenalidomide, azacitidine and the combination of azacitidine + lenalidomide in patients with lymphoma; grading the adverse events using Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0|While taking the study drug and 30 days after the last dose|||participants|||Number
817915|NCT01121757|Primary|Overall Response|"Number of patients with a complete or partial response using Cheson criteria for lymphoma.
A complete response is defined as a complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy. A partial response is defined as a greater than or equal to 50% decrease in the sum of the products of the greatest diameters of 6 largest dominant nodes or nodal masses. No increase in size of nodes, liver or spleen and no new sites of disease. Patients who have been on study drug for at least 2 months will be considered evaluable for response as long as they have had repeat imaging to assess response or clear progression based on physical exam."|Response will be assessed after at least 6 months on combination drug.|Only subjects that completed combination drug will be included in analysis.|||||
817916|NCT01121757|Primary|Overall Response|"Number of patients with a complete or partial response using Cheson criteria for lymphoma.
A complete response is defined as a complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy. A partial response is defined as a greater than or equal to 50% decrease in the sum of the products of the greatest diameters of 6 largest dominant nodes or nodal masses. No increase in size of nodes, liver or spleen and no new sites of disease. Patients who have been on study drug for at least 2 months will be considered evaluable for response as long as they have had repeat imaging to assess response or clear progression based on physical exam."|Response will be assessed after at least 4 months on second drug.|Everyone who started the second drug regimen||participants|||Number
817917|NCT01121757|Primary|Overall Response|"Number of patients with a complete or partial response using Cheson criteria for lymphoma.
A complete response is defined as a complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy. A partial response is defined as a greater than or equal to 50% decrease in the sum of the products of the greatest diameters of 6 largest dominant nodes or nodal masses. No increase in size of nodes, liver or spleen and no new sites of disease. Patients who have been on study drug for at least 2 months will be considered evaluable for response as long as they have had repeat imaging to assess response or clear progression based on physical exam."|Response will be assessed after at least 4 months on first study drug.|Everyone who started the first drug regimen||participants|||Number
817918|NCT01121757|Primary|Response Predicted by Molecular Signatures Compared to True Response|"The predicted response (response to therapy vs. no response to therapy) using gene sequencing will be compared to the overall true response (reported in Primary Outcome 2)."|approximately one year|The number of participants who were evaluated for a response were analyzed to see if the prediction of response vs. no response through gene expression matched the true response.||participants|||Number
817919|NCT01123356|Secondary|Dose Reductions Due to Adverse Events.|Number of dose reductions due to toxicity.|30 weeks|Adverse Events were assessed at each treatment visit. All patients who were treated are included in the adverse event analysis.||dose reductions|||Number
817920|NCT01123356|Secondary|Frequency of Adverse Events|Number of adverse events occuring in greater than 20% of subjects|30 weeks|Adverse Events were assessed at each treatment visit. All patients who were treated are included in the adverse event analysis.||events|||Number
817921|NCT01123356|Secondary|Biomarkers Changes During Treatment.|Biomarkers changes during treatment. A minimum of 5 subjects will be enrolled in the biomarkers sub-study. Only those subjects enrolled at MUSC will be considered for the biomarkers sub-study. At day 1 of cycle 1, day 8 of cycle 1, day 1 of cycle 2 and day 8 of cycles 2, blood samples will be obtained for assessment of biomarkers.|30 Weeks|The biomarker sub-study was not completed due to poor accrual to this substudy and lack of feasibility.|||||
817922|NCT01123356|Secondary|Frequency of Adverse and Severe Adverse Events|Frequency of adverse and severe adverse events|30 weeks|Adverse Events were assessed at each treatment visit. All patients who were treated are included in the adverse event analysis.||participants|||Number
817923|NCT01123356|Primary|Overall Response Rate|"Obtain early assessment of the efficacy of the intracycle sequential administration of ofatumumab and lenalidomide in the treatment of chronic lymphocytic leukemia (CLL) after prior use of rituximab. Response was categorized according to the IW-CLL criteria which includes the following: Complete remission (CR), CR with incomplete marrow recovery (CRi)Partial remission (PR), Progressive disease (PD), Stable disease (SD).
Overall response rate was defined as those who experienced a response of CR, CRi or PR."|30 Weeks|Overall response rate is defined as response (CR, CRi or PR) at cycle 3 or cycle 6 evaluation. Only patients who completed at least 3 cycles were eligible for analysis for this outcome measure.||percentage of participants||95% Confidence Interval|Number
817924|NCT01123395|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. AUC (0-∞) was calculated as the sum of AUC (0-t) plus the ratio of the last measurable Colcrys® plasma concentration to the elimination rate constant.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.25, 0.5, 1.0, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 18, 20, 24, 36, and 48 hours after drug administration|Plasma concentration data for 15 of 16 participants were used in the statistical analysis. One subject dropped from the study before Period II dosing for personal reasons.||ng-hr/mL||Standard Deviation|Mean
827179|NCT01202253|Secondary|Number of Participants Who Received Water-based and Ethanol-based Formulation||Baseline|Full analysis set included all participants who met the defined eligibility criteria.||participants|||Number
817925|NCT01123395|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC (0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable Colcrys® concentration (t), as calculated by the linear trapezoidal rule|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.25, 0.5, 1.0, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 18, 20, 24, 36, and 48 hours after drug administration|Plasma concentration data for 15 of 16 participants were used in the statistical analysis. One subject dropped from the study before Period II dosing for personal reasons.||ng-hr/mL||Standard Deviation|Mean
817926|NCT01123395|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that Colcrys® reaches in the plasma|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.25, 0.5, 1.0, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 18, 20, 24, 36, and 48 hours after drug administration|Plasma concentration data for 15 of 16 participants were used in the statistical analysis. One subject dropped from the study before Period II dosing for personal reasons.||ng/mL||Standard Deviation|Mean
817927|NCT01123512|Primary|Proportion of Participants With Study Success|"Patient success will be defined as:
Reduction in VCF fracture-related pain at 12 months by >15 mm from baseline as measured by a 100 mm Visual Analog Scale (VAS),
Maintenance or improvement in function at 12 months from baseline as measured by the 100 point Oswestry Disability Index (ODI), and
Absence of device-related serious adverse events, defined as device-related adverse events requiring surgical reintervention or retreatment at the index level, including revision, removal, reoperation, and/or supplemental fixation"|12 Month Post-op|||participants|||Number
817928|NCT01123642|Secondary|Clinician Administered PTSD Scale||one year||||||
817929|NCT01123642|Secondary|Quality of Life Scale||one year||||||
817930|NCT01123642|Secondary|Inventory of Psychosocial Recovery (IPR)||one year||||||
817931|NCT01123642|Primary|World Health Organization Disability Assessment Schedule II (WHODAS II)|Participants complete the WHODAS II at baseline, 4 months, 8 months, and 12 months. The WHODAS II measures general disability related to multiple domains (i.e., understanding and communicating, getting around, self care, getting along with people, life activities, work/school, participation in society). Total scores range from 1 (no disability) to 5 (extreme/cannot do), with higher scores indicating more impairment.|one year|A total of 345 participants were enrolled, of which 309 were deemed eligible. Analyses are conducted with the total sample N = 309, followed over time.||units on a scale||Standard Deviation|Mean
817932|NCT01123850|Secondary|Outcome Measure - Pain, Life Quality, Satisfaction||PreOp, Surgery, 6M, 12M|Study was terminated due to slow enrollment, there was no data analysis|||||
817933|NCT01123850|Primary|Fusion Assessment|Fusion at 12M using radiograph Fusion Mass at 12M using CT|6 M, 12 M|Study was terminated due to slow enrollment, there was no data analysis|||||
817934|NCT01123889|Primary|Pain and Disability of the Shoulder Through Validated Questionnaires|Patients will be asked to fill out questionnaires to provide insight into how their condition is progressing, consisting of components of the American Shoulder and Elbow Surgeons (ASES) total score. The maximum score is 100, made up by pain and function components' sums. Only the total score is recorded, 100 being full normal function without pain, 0 being severe pain and no function.|15 minutes prior to initial injection of corticosteroid versus platelet rich plasma|||units on a scale||Standard Deviation|Mean
817935|NCT01123889|Primary|Pain and Disability of the Shoulder Through Validated Questionnaires|Patients will be asked to fill out questionnaires to provide insight into how their condition is progressing, consisting of components of the American Shoulder and Elbow Surgeons (ASES) total score. The maximum score is 100, made up by pain and function components' sums. Only the total score is recorded, 100 being full normal function without pain, 0 being severe pain and no function.|12 weeks from initial injection of corticosteroid versus platelet rich plasma|||units on a scale||Standard Deviation|Mean
817936|NCT01123889|Primary|Pain and Disability of the Shoulder Through Validated Questionnaires|Patients will be asked to fill out questionnaires to provide insight into how their condition is progressing, consisting of components of the American Shoulder and Elbow Surgeons (ASES) total score. The maximum score is 100, made up by pain and function components' sums. Only the total score is recorded, 100 being full normal function without pain, 0 being severe pain and no function.|6 weeks from initial injection of corticosteroid versus platelet rich plasma|||units on a scale||Standard Deviation|Mean
817937|NCT01123928|Secondary|"Belief That Doctors and Nurses at the Hospital Have Very Good Attitudes"|Measured as a percentage of subjects who agree with the statement in a questionnaire.|Assessed during day of screening examination|Analysis was conducted for all participants who responded to this question in the survey.||percentage of respondents|||Number
817938|NCT01123928|Secondary|"Belief That Surgeons at the Hospital Are Highly Skilled"|Measured as a percentage of subjects who agree with the statement in a questionnaire.|Assessed during day of screening examination|Analysis was conducted for all participants who responded to this question in the survey.||percentage of respondents|||Number
817939|NCT01123928|Secondary|"Belief That Vision Will Improve a Lot Following Surgery"|Measured as a percentage of subjects who agree with the statement in a questionnaire.|Assessed during day of screening examination|Analysis was conducted for all participants who responded to this question in the survey.||percentage of respondents|||Number
817940|NCT01123928|Secondary|Belief That Surgery Will be Painful|Measured as a percentage of subjects who agree with the statement in a questionnaire.|Assessed during day of screening examination|Analysis was conducted for all participants who responded to this question in the survey.||percentage of respondents|||Number
817941|NCT01123928|Secondary|Knowledge That Cataract Can be Treated|Measured as a percentage of subjects who correctly answer the question in a questionnaire.|Assessed during day of screening examination|Analysis was conducted for all participants who responded to this question in the survey.||percentage of respondents|||Number
817942|NCT01123928|Secondary|Attendance at Hospital for Pre-operative Examination|Measured as a percentage of people who presented to the hospital within 6 months after screening (positive) out of total subjects.|within 6 months after screening examination|All participants who completed the study were analyzed.||percentage of participants|||Number
817943|NCT01123928|Primary|Decision to Undergo Cataract Surgery (Surgery Acceptance)|Measured as a percentage of subjects who decide to undergo cataract surgery within 6 months after screening (positive) out of total subjects.|within 6 months after screening examination|All participants who completed the study were analyzed.||percentage of participants|||Number
817949|NCT01123980|Secondary|Number of Hypoglycaemic Episodes - Severe and Minor|Hypoglycaemic episodes (hypos) summarised based on American Diabetes Association classification (severe, documented symptomatic, asymptomatic, probable symptomatic, and relative hypoglycaemia) and according to additional definition (minor hypoglycaemia). Severe hypos: requiring another person to actively administer resuscitative actions. Minor hypos: symptoms with plasma glucose below 3.1 mmol/L (56 mg/dl), or any asympomatic plasma glucose below 3.1 mmol/L.|Weeks 0-24|The safety analysis set contains all subjects exposed to at least one dose of investigational product(s).||episodes|||Number
817950|NCT01123980|Secondary|Number of Hypoglycaemic Episodes - All||Weeks 0-24|The safety analysis set contains all subjects exposed to at least one dose of investigational product(s).||episodes|||Number
817951|NCT01123980|Secondary|Percentage of Subjects Achieving HbA1c Below or Equal to 6.5%|The percentage of subjects achieving the treatment target for glycosylated haemoglobin A1c after 24 weeks of treatment|Week 24|Full analysis set using LOCF (last observation carried forward) consists of all randomised subjects who were exposed to at least one dose of the trial product(s).||percentage (%) of subjects|||Number
817952|NCT01123980|Secondary|Percentage of Subjects Achieving HbA1c Below 7.0%|The percentage of subjects achieving the treatment target for glycosylated haemoglobin A1c after 24 weeks of treatment|Week 24|Full analysis set using LOCF (last observation carried forward) consists of all randomised subjects who were exposed to at least one dose of the trial product(s).||percentage (%) of subjects|||Number
817953|NCT01123980|Secondary|9-point Plasma Glucose Profiles|Glycaemic control measured by 9-point plasma glucose (SPMG) profiles. The 9 timepoints for self-measurement during the day were: before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, before bedtime, at 2-4 a.m. and before breakfast the following day.|Week 24|Full analysis set using LOCF (last observation carried forward) consists of all randomised subjects who were exposed to at least one dose of the trial product(s).||mmol/L||Standard Error|Mean
817954|NCT01123980|Primary|Change in Glycosylated Haemoglobin (HbA1c)||Week 0, week 24|Full analysis set using LOCF (last observation carried forward) consists of all randomised subjects who were exposed to at least one dose of trial product(s)||percentage of glycosylated haemoglobin||Standard Error|Least Squares Mean
817955|NCT01124006|Primary|Treatment Emergent Adverse Events- Relationship to Study Drug|Number of patients with Treatment Emergent Adverse Events that were designated as Possibly or Probably Related to Study Drug.|12 month period and annual telephone contact at 24 and 36 months for subject health status follow-up|Safety Population||participants|||Number
817956|NCT01124006|Primary|Treatment Emergent Adverse Events- Relationship to Study Drug|Number of patients with Treatment Emergent Adverse Events that were designated as Definitely Related to Study Drug.|Through a 12 month period and annual telephone contact at 24 and 36 months for subject health status follow-up.|Safety Population||participants|||Number
817957|NCT01124006|Secondary|Change in Mental Component Summary Quality of Life Measure Assessed by Short Form SF-36 at 12 Months From Baseline.|The 36-item Short Form Health Survey (SF-36) is a patient reported outcome survey that evaluates functional health and well-being. The survey is converted into two summary measures (the Physical Component- PCS and Mental Component- MCS) that are scored from 0 to 100 (where 100 indicates the highest level of health)|12 months|"FAS Population
One subject from the rhGDF-5 1.0mg group (out of 10 subjects total) did not complete the MCS, SF-36 at Baseline."||units on a scale||Standard Deviation|Mean
817958|NCT01124006|Secondary|Change in Physical Component Summary of Quality of Life Measure Assessed by Short-Form 36 at 12 Months From Baseline.|The 36-item Short Form Health Survey (SF-36) is a patient reported outcome survey that evaluates functional health and well-being. The survey is converted into two summary measures (the Physical Component- PCS and Mental Component- MCS) that are scored from 0 to 100 (where 100 indicates the highest level of health)|12 months|"FAS Population
One subject from the rhGDF-5 1.0mg group (out of 10 subjects total) did not complete the PCS, SF-36 at Baseline."||units on a scale||Standard Deviation|Mean
817959|NCT01124006|Secondary|Change in Pain Visual Analogue Scale (VAS) at 12 Months From Baseline.|The Visual Analogue Scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line ( that is approximately 10cm long) with 'No Pain' (score of 0=0cm) listed on the left and 'Very severe pain' (score of 10=10cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their back.|12 months|FAS Population||units on a scale||Standard Deviation|Mean
817960|NCT01124006|Secondary|Change in Function Assessed by Oswestry Disability Index Change at 12 Months From Baseline.|The Oswestry Disability Index (ODI) is a 10-category (Pain Intensity, Personal Care, Lifting, Walking, Sitting, Standing, Sleeping, Sex Life, Social Life, Traveling) disability measurement scale with a graded response from 0 to 5, with 0 being the best score (no impairment) to 5 being the worst score (significant impairment). ODI score for a subject is calculated by adding the scores and converting the score to a 100 point scale.|12-month|FAS Population||units on a scale||Standard Deviation|Mean
817961|NCT01124006|Primary|Neurological Assessment for Motor Function and Reflexes/Sensory|"Neurological Assessment for Motor Function and Reflexes/Sensory- Number of patients with Clinically Significant Abnormal results at 12 months.
For Motor Function, Clinically Significant Abnormal results are determined by the surgeon investigator and are further classified by grade: 0= No Movement, 1= Flicker/trace of contraction, 2=Active movement when gravity removed, 3= Active movement against gravity, 4= Active Movement against gravity and resistance.
For Reflexes/Sensory, Clinically Significant Abnormal results are determined by the surgeon investigator and are based on exams of the Knee, Ankle, L3-L5 Dermatone, and S1 Dermatome. Tension signs are evaluated with a straight leg raise to determine at which point, if any, sciatic pain occurs."|12 months|"Safety Population
For the Neurological Assessment at 12 months, only 8 subjects from the rhGDF-5 1.0mg group (out of 10 subjects total) completed the assessment, only 3 subjects from the rhGDF-5 2.0mg group (out of 4 subjects total) completed the assessment, and none of the placebo subjects (out of 10 total subjects) completed the assessment."||participants|||Number
817982|NCT01124149|Secondary|Percentage of Subjects in Clinical Remission at Month 12 of Maintenance Phase|"Clinical remission was defined as a score of 0 for rectal bleeding and stool frequency.
Rectal bleeding is assessed on a scale from 0-3 (0 = no rectal bleeding, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood).
Stool frequency is assessed on a scale of 0-2 (0 = 0-1 more than normal per day, 1 = 2-3 more than normal per day, 2 = 4 or more than normal per day)."|12 months|Maintenance Phase Efficacy Population included all subjects who, during the Maintenance Phase, took at least 1 dose of investigational product and had at least 1 post-dose efficacy assessment.||percentage of subjects|||Number
817962|NCT01124045|Secondary|Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation|Lacrimation was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Excessive lacrimation (tear production and secretion, 1-3) is a symptom of ocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.|Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week|Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.||Percentage of patients|||Number
817963|NCT01124045|Secondary|Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia|Photophobia was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Photophobia (abnormal intolerance to visual perception of light) is a symptom of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.|Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week|Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.||Percentage of patients|||Number
817964|NCT01124045|Secondary|Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity|Wound integrity was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Lack of wound integrity (healing, 1-3) is a sign of inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.|Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week|Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.||Percentage of patients|||Number
817965|NCT01124045|Secondary|Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis|Vitritis was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Vitritis (accumulation of inflammatory cells or exudates in the vitreous humor, the fluid that fills the middle chamber of the eye) is a sign of ocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.|Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week|Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.||Percentage of patients|||Number
817966|NCT01124045|Secondary|Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon|Hypopyon was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Hypopyon (pus in the anterior chamber of the eye) is a sign of ocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.|Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week|Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.||Percentage of patients|||Number
817967|NCT01124045|Secondary|Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis|Chemosis was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Chemosis (swelling of the conjunctiva) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.|Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week|Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.||Percentage of patients|||Number
817968|NCT01124045|Secondary|Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection|Ciliary/limbal injection was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Ciliary/limbal injection (redness of the white sclera of the eye near the limbal ring) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.|Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week|Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.||Percentage of patients|||Number
817969|NCT01124045|Secondary|Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection|Conjunctival injection was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Conjunctival injection (redness of the white sclera of the eye) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.|Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week|Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.||Percentage of patients|||Number
817970|NCT01124045|Secondary|Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity|Corneal clarity was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Lack of corneal clarity (1-3) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.|Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week|Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.||Percentage of patients|||Number
817971|NCT01124045|Secondary|Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade|Anterior chamber flare was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. The presence of flare (increased protein levels) in the anterior chamber of the eye (the fluid-filled space inside the eye between the iris and the cornea's innermost surface) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.|Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week|Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.||Percentage of patients|||Number
817972|NCT01124045|Secondary|Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade|Anterior chamber cell grade was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 5-point scale: Grade 0=0 cells; Grade 1=1 to 10 cells; Grade 2=11 to 20 cells; Grade 3=21 to 50 cells; Grade 4=>50 cells. The presence of blood cells (red and white) in the anterior chamber of the eye (the fluid-filled space inside the eye between the iris and the cornea's innermost surface) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.|Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week|Intent-to-treat (ITT): All patients who received at least 1 dose of study medication. One patient had missing anterior cell grade assessment at all visits.||Percentage of patients|||Number
817973|NCT01124045|Secondary|Global Assessment Score of Postoperative Inflammation by Visit|A Global Assessment Score (GAS) was assigned by the Investigator based on the clinical evidence of postoperative inflammation: 0=clear, 1=improving satisfactorily; 2=not improving or worsening, withdrawal from study indicated to allow appropriate alternative therapy to be instituted. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.|Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week|Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.||Percentage of patients|||Number
817974|NCT01124045|Primary|Percentage of Patients With an Anterior Cell Grade of 0 (no Cells) at Day 15 ± 2 Days|Anterior cell grade was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 5-point scale: Grade 0=0 cells; Grade 1=1 to 10 cells; Grade 2=11 to 20 cells; Grade 3=21 to 50 cells; Grade 4=>50 cells. The presence of blood cells (red and white) in the anterior chamber of the eye (the fluid-filled space inside the eye between the iris and the cornea's innermost surface) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation.|Day 15 ± 2 days|Intent-to-treat (ITT): All patients who received at least 1 dose of study medication. One patient (DUREZOL) had missing anterior cell grade assessment at all visits.||Percentage of patients|||Number
817975|NCT01124097|Primary|Change From Baseline to Endpoint in Mean Pain|"The efficacy analysis was restricted to the primary efficacy variable in the analysis population. The intended treatment period, starting on the day of the randomization and ending at the efficacy cut-off date (October 31, 2011), was the basis for the analysis.
The primary efficacy variable was the difference between the mean values of 7 daily pain scores preceding the efficacy cut-off date (endpoint mean pain score), and before randomization (baseline mean pain score), respectively. The daily pain scores were based on the morning response to the 11-point Numeric Rating Pain Scale (NRPS) question relating to average pain intensity over the last 24 hours. The NPRS is an 11-point scale from 0-10 [“0” = no pain; “10” = the most intense pain imaginable]"|baseline to endpoint|efficacy population||units on a scale||Standard Error|Least Squares Mean
817976|NCT01124149|Secondary|Percentage of Subjects in Partial Remission at Week 8 of Acute Phase|"Partial remission was defined as a modified UC-DAI <=3 with a combined stool frequency and rectal bleeding score of <=1 and not in complete remission.
The modified UC-DAI score is the sum of the scores of 4 parameters (stool frequency, rectal bleeding, endoscopy score, and physician global assessment), each scoring between 0 and 3, making 12 the worst score.
Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal, 1 = mild , 2 = moderate, 3 = severe).
Rectal bleeding is assessed on a scale from 0-3 (0 = no rectal bleeding, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood).
Stool frequency is assessed on a scale of 0-2 (0 = 0-1 more than normal per day, 1 = 2-3 more than normal per day, 2 = 4 or more than normal per day)."|8 weeks|Acute Phase Safety Population included all subjects who, during the Acute Phase, took at least 1 dose of investigational product.||percentage of subjects|||Number
817977|NCT01124149|Secondary|Percentage of Subjects in Complete Remission at Week 8 of Acute Phase|"Complete (clinical and endoscopic) remission was defined as a modified UC-DAI <=1 with a score of 0 for rectal bleeding and stool frequency and at least a 1-point reduction in endoscopy score from baseline.
The modified UC-DAI score is the sum of the scores of 4 parameters (stool frequency, rectal bleeding, endoscopy score, and physician global assessment), each scoring between 0 and 3, making 12 the worst score.
Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal, 1 = mild , 2 = moderate, 3 = severe).
Rectal bleeding is assessed on a scale from 0-3 (0 = no rectal bleeding, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood).
Stool frequency is assessed on a scale of 0-2 (0 = 0-1 more than normal per day, 1 = 2-3 more than normal per day, 2 = 4 or more than normal per day)."|8 Weeks|Acute Phase Safety Population included all subjects who, during the Acute Phase, took at least 1 dose of investigational product.||percentage of subjects|||Number
817978|NCT01124149|Secondary|Improvement in Stool Frequency Symptoms During the Acute Phase|"Improvement was defined as at least a 1-point reduction in the stool frequency score from baseline at each assessment point.
Stool frequency is assessed on a scale of 0-2 (0 = 0-1 more than normal per day, 1 = 2-3 more than normal per day, 2 = 4 or more than normal per day)."|3 and 8 weeks|Acute Phase Safety Population included all subjects who, during the Acute Phase, took at least 1 dose of investigational product.||percentage of subjects|||Number
817979|NCT01124149|Secondary|Improvement in Rectal Bleeding Score During the Acute Phase|"Improvement was defined as at least a 1-point reduction in the rectal bleeding score from baseline at each assessment point.
Rectal bleeding is assessed on a scale from 0-3 (0 = no rectal bleeding, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood)."|3 and 8 weeks|Acute Phase Safety Population included all subjects who, during the Acute Phase, took at least 1 dose of investigational product.||percentage of subjects|||Number
817980|NCT01124149|Secondary|Percentage of Subjects With Mucosal Healing at 12 Months of Maintenance Phase|"Subjects with mucosal healing were defined as subjects who had an endoscopy score <=1.
Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal, 1 = mild , 2 = moderate, 3 = severe)."|12 months|Maintenance Phase Efficacy Population included all subjects who, during the Maintenance Phase, took at least 1 dose of investigational product and had at least 1 post-dose efficacy assessment.||percentage of subjects|||Number
817981|NCT01124149|Secondary|Relapse in Ulcerative Colitis at Month 12 of Maintenance Phase|Relapse was defined in the Maintenance Phase as the need for alternative treatment for UC (including surgery); subjects were classified as having a relapse if they had withdrawn from the study due to a lack of efficacy.|12 months|Maintenance Phase Efficacy Population included all subjects who, during the Maintenance Phase, took at least 1 dose of investigational product and had at least 1 post-dose efficacy assessment.||percentage of subjects|||Number
817983|NCT01124149|Primary|Percentage of Subjects in Complete Remission at Month 12 of Maintenance Phase|"Complete remission was defined as a modified Ulcerative Colitis Disease Activity Index (UC-DAI) <=1 with a score of 0 for rectal bleeding and stool frequency and at least a 1-point reduction in endoscopy score from baseline.
The modified UC-DAI score is the sum of the scores of 4 parameters (stool frequency, rectal bleeding, endoscopy score, and physician global assessment), each scoring between 0 and 3, making 12 the worst score.
Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal, 1 = mild , 2 = moderate, 3 = severe).
Rectal bleeding is assessed on a scale from 0-3 (0 = no rectal bleeding, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood).
Stool frequency is assessed on a scale of 0-2 (0 = 0-1 more than normal per day, 1 = 2-3 more than normal per day, 2 = 4 or more than normal per day)."|12 months|Maintenance Phase Efficacy Population included all subjects who, during the Maintenance Phase, took at least 1 dose of investigational product and had at least 1 post-dose efficacy assessment.||percentage of subjects|||Number
817984|NCT01124162|Secondary|AUC0-inf of Losartan Carboxy Acid(Area Under the Concentration-time Curve From Time Zero to Infinity)|Informational comparison of AUC0-inf values for the metabolite Losaran Carboxy Acid.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
817985|NCT01124162|Secondary|AUC0-t of Losartan Carboxy Acid (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Informational comparison of AUC0-t values for the metabolite Losartan Carboxy Acid.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
817986|NCT01124162|Secondary|Cmax of Losartan Carboxy Acid (Maximum Observed Concentration of Drug Substance in Plasma)|Informational comparison of Cmax values for the metabolite Losartan Carboxy Acid.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
817987|NCT01124162|Primary|AUC0-inf of Losartan (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on Losartan AUC0-inf.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
817988|NCT01124162|Primary|AUC0-t of Losartan (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on Losartan AUC0-t.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
817989|NCT01124162|Primary|Cmax of Losartan (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Losartan Cmax.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
817990|NCT01124175|Secondary|AUC0-inf or Losartan Carboxy Acid (Area Under the Concentration-time Curve From Time Zero to Infinity)|Informational comparison of AUC0-inf values for the metabolite Losartan Carboxy Acid.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
817991|NCT01124175|Secondary|AUC0-t of Losartan Carboxy Acid (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Informational comparison of AUC0-t values for the metabolite Losartan Carboxy Acid.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
817992|NCT01124175|Secondary|Cmax of Losartan Carboxy Acid (Maximum Observed Concentration of Drug Substance in Plasma)|Informational comparison of Cmax values for the metabolite Losartan Carboxy Acid.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
817993|NCT01124175|Primary|AUC0-inf of Losartan (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on Losartan AUC0-inf.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed. However, one subject had a baseline concentration greater than 5% of Cmax and therefore was not included in the analysis.||ng*h/mL||Standard Deviation|Mean
817994|NCT01124175|Primary|AUC0-t of Losartan (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on Losartan AUC0-t.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed. However, one subject had a baseline concentration greater than 5% of Cmax and therefore was not included in the analysis.||ng*h/mL||Standard Deviation|Mean
817995|NCT01124175|Primary|Cmax of Losartan (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Losartan Cmax.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed. However, one subject had a baseline concentration greater than 5% of Cmax and therefore was not included in the analysis.||ng/mL||Standard Deviation|Mean
817996|NCT01124188|Secondary|Changes in Short Physical Performance Battery From Ph 2 Baseline Till 14 Weeks|"Change in SPPB scores from randomization to 14 weeks for both arms.
The Short Physical Performance Battery (SPPB) assesses physical performance. The SPPB scores range from 0-12 and assess lower extremity strength, balance, and gait speed, three meaningful predictors of morbidity and mortality in late-life. Lower scores on the SPPB indicates greater limitations. Improvement of 0.5 points indicate clinically meaningful improvement in physical performance"|Baseline and 14 weeks|||units on a scale||95% Confidence Interval|Least Squares Mean
817997|NCT01124188|Secondary|Change in Roland Morris Disability Questionnaire (RMDQ) From P2 Baseline to 14 Weeks|"Change in RMDQ from randomization to 14 weeks. The Roland-Morris is a 24-item self-report questionnaire about how low-back pain affects functional activities. Each question is worth one point so scores can range from 0 (no disability) to 24 (severe disability).
Improvement of 30% is clinically meaningful"|Baseline and 14 weeks|||units on a scale||95% Confidence Interval|Least Squares Mean
817998|NCT01124188|Primary|Proportion Responding Initially by Treatment Arm During 14 Weeks Post Randomization|The PHQ-9 depression questionnaire scores range from 0 to 27. The higher the score the more severe the depression. A PHQ-9 score less than or equal to 5 represents absence of depression. The Numeric Rating scale is a self report pain scale ranging from 0 to 20. Higher numbers indicate more pain. Response in this study was defined as two consecutive PHQ-9 scores < or = to 5 AND Numeric Rating Scale for pain (NRS) > or = 30% reduction from study entry.|14 weeks|||Participants|||Count of Participants
817999|NCT01124292|Primary|Short Questionnaire at the End of Each Session Group-A&-B:5 Consecutive TDS Trials (Intervals Ranging From Two to Ten Days) Group-C:Computer and PWC Within a Week, Over 6 Weeks.|Q1.How much thought was necessary to decide where to put your tongue to issue a specific command?1:A lot,5:A Little Q2.Was the speed of the movement of the cursor on the computer screen:1:Too slow,3:Just right,5:Too fast Q3.How difficult was pointing accurately at specific targets on the computer screen?1:Very difficult,5:Very easy Q4.Accurately guiding the powered wheelchair through the obstacle course was:1:Very difficult,5:Very easy Q4.Accurately guiding the powered wheelchair through the obstacle course was:1: Very difficult,5:Very easy (TDS:Q4-1.Unlatched,Q4-2.Latched,Q4-3.Semi-pro,SnP:Q4-4.Latched) Q5.Was the speed of the wheelchair:1:Too slow,5:Too fast Q6.Was the movement of the wheelchair:1:Very jerky,5:Very smooth Q7.Was TDS effective in dialing phone numbers:1:Completely ineffective,5:Very effective Q8.Was TDS effective in doing the weight shift:1:Completely ineffective,5:Very effective|24 months|||scores on a scale||Standard Deviation|Mean
818000|NCT01124292|Primary|Weight Shifting Using the Tongue Drive System (TDS) for People With Spinal Cord Injuries (Completion Time)|"The TDS commands were designated to change the wheelchair mode from driving to tilting and to control the wheelchair angle. The completion time was from the initial mode change to the end of the weight shifting.
Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks."|24 months|||seconds||Standard Deviation|Mean
818001|NCT01124292|Primary|Phone Dialing Using the Tongue Drive System (TDS) for People With Spinal Cord Injuries (Completion Time)|"Randomly selected ten-digit target phone number was visually prompted on the top of the smartphone screen, and the subject entered the same number in the following line as quickly and as accurately as possible. If the wrong number was registered, then the subjects were allowed to delete the one by issuing the deleting command.At the end of the number entering, the subject needs to move the cursor at the green colored “CALL” button, in the middle of the bottom line, and it should be selected to complete the trial. The completion time and error rate were considered to evaluate the performance.
Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks."|24 months|||seconds||Standard Deviation|Mean
818002|NCT01124292|Primary|Driving a Wheelchair Using TDS vs SnP (Number of Navigation Errors)|"An obstacle course will be laid out in an open space and the subjects drive an electric powered wheelchair using the tongue drive system (TDS) and the sip-and-puff device (SnP) to drive through the obstacle course. The operator measured the amount of time it takes for the subjects to begin and return back to the starting point and counts the number of collisions with the obstacles.
Unlatched and latched: utilize four TDS commands for forward, backward, left, and right motions.
Unlatched: hold their tongue to keep the PWC moving. Latched: (5 linear speed levels:Backward, Stop, Forward-1, Forward-2, and Forward-3) Issuing the forward or backward commands can increase or decrease the linear speed.
Semi-proportional: Quickly touching the left and right cheeks- forward or backward commands, sliding tongue over the lip- steer the PWC to the left or right.
Group-A&-B:5 consecutive TDS trials (intervals ranging from two to ten days) Group-C:computer and PWC within a week, over 6 weeks."|24 months|||Navigation Errors||Standard Deviation|Mean
818003|NCT01124292|Primary|Driving a Wheelchair Using TDS vs SnP (Completion Time)|"An obstacle course will be laid out in an open space and the subjects drive an electric powered wheelchair using the tongue drive system (TDS) and the sip-and-puff device (SnP) to drive through the obstacle course. The operator measured the amount of time it takes for the subjects to begin and return back to the starting point and counts the number of collisions with the obstacles.
Unlatched and latched: utilize four TDS commands for forward, backward, left, and right motions.
Unlatched: hold their tongue to keep the PWC moving. Latched: (5 linear speed levels:Backward, Stop, Forward-1, Forward-2, and Forward-3) Issuing the forward or backward commands can increase or decrease the linear speed.
Semi-proportional: Quickly touching the left and right cheeks- forward or backward commands, sliding tongue over the lip- steer the PWC to the left or right.
Group-A&-B:5 consecutive TDS trials (intervals ranging from two to ten days) Group-C:computer and PWC within a week, over 6 weeks."|24 months|||seconds||Standard Deviation|Mean
818004|NCT01124292|Primary|On-screen Maze Using TDS, Keypad, and SnP (Sum of Deviation / 1000)|"Subjects were instructed to use four directional commands (Left, Right, Up, and Down) to move the mouse cursor using the tongue drive system (TDS), keypad, and the sip-and-puff device (SnP) as fast and accurately as possible on a maze. One out of eight maze patterns was randomly selected in each round. The performance measures were completion time (CT) from start to end and sum of deviation (SoD) from the track. SoD was calculated as the sum of all areas between the actual trajectory of the cursor when it was out of the track and the closest edge of the track divided by 1000.
Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks."|24 months|||pixel^2/1000||Standard Deviation|Mean
818005|NCT01124292|Primary|On-screen Maze Using TDS, Keypad, and SnP (Completion Time)|"Subjects were instructed to use four directional commands (Left, Right, Up, and Down) to move the mouse cursor using the tongue drive system (TDS), keypad, and the sip-and-puff device (SnP) as fast and accurately as possible on a maze. One out of eight maze patterns was randomly selected in each round. The performance measures were completion time (CT) from start to end and sum of deviation (SoD) from the track. SoD was calculated as the sum of all areas between the actual trajectory of the cursor when it was out of the track and the closest edge of the track divided by 1000.
Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks."|24 months|||seconds||Standard Deviation|Mean
818006|NCT01124292|Primary|Information Transfer Rate (Percentage of Correctly Completed Commands)|Computer randomly highlights one out of six or four commands and the subjects issue that particular command using the tongue drive system (TDS) and the sip-and-puff device (SnP). Subjects are given a time period (T). The time intervals for the TDS:(Group-A)2.0s,1.5s,1.0s,(Group-B &-C)1.0s,0.7s,0.5s,SnP:(Group-C)1.2s,1.0s,0.7s. The saturated results were observed from the second session during Group-A trials. Therefore, we reduced the time period from the Group-B trial. Moreover, the SnP device needs a certain time period to issue a command and we observed that the minimum possible time period was 0.7 seconds. At the end the percentage of correctly selected commands is calculated and fed into an equation along with the time given to the subjects for each selection.Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.|24 months|||Percentage of correctly completed cmd(%)||Standard Deviation|Mean
818007|NCT01124292|Primary|Information Transfer Rate (ITR)|Computer randomly highlights one out of six or four commands and the subjects issue that particular command using the tongue drive system (TDS) and the sip-and-puff device (SnP). Subjects are given a time period (T). The time intervals for the TDS:(Group-A)2.0s,1.5s,1.0s,(Group-B &-C)1.0s,0.7s,0.5s, SnP:(Group-C)1.2s,1.0s,0.7s. The saturated results were observed from the second session during Group-A trials. Therefore, we reduced the time period from the Group-B trial. Moreover, the SnP device needs a certain time period to issue a command and we observed that the minimum possible time period was 0.7 seconds. At the end the percentage of correctly selected commands is calculated and fed into an equation along with the time given to the subjects for each selection.Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.|24 months|||bits per minute||Standard Deviation|Mean
818008|NCT01124292|Primary|Fitts' Law: Multi-Directional Tapping Using TDS, Keypad, and Mouse (Error Rate)|"Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Multi-directional Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. The error rate is the rate of outside of targets vs. total targets.
Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks."|24 months|||Percentage of Missed Targets (%)||Standard Deviation|Mean
818009|NCT01124292|Primary|Fitts' Law: Multi-Directional Tapping Using TDS, Keypad, and Mouse (Throughput)|"Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Multi-directional Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. This data was then fed into an equation, which provided the throughput measure. The unit of throughput is bits per second.
The high value of throughput means better performance. Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks."|24 months|||bits per second||Standard Deviation|Mean
818010|NCT01124292|Primary|Fitts' Law: Center-Out Tapping Using TDS, Keypad, Mouse, and SnP (Movement Time)|"Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Center-out Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. The movement time is the cursor movement time from the initial movement to the final movement for each target. This task is tested by the TDS, keypad, mouse and the sip-and-puff device (SnP).
Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks."|24 months|||seconds||Standard Deviation|Mean
818011|NCT01124292|Primary|Fitts' Law: Center-Out Tapping Using TDS, Keypad, Mouse, and SnP (Error Rate)|"Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Center-out Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. The error rate is the rate of outside of targets vs. total targets. This task is tested by the TDS, keypad, mouse and the sip-and-puff device (SnP).
Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks."|24 months|||Percentage of Missed Targets (%)||Standard Deviation|Mean
818012|NCT01124292|Primary|Fitts' Law: Center-Out Tapping Using TDS, Keypad, Mouse, and SnP (Throughput)|"Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Center-out Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. This data was then fed into an equation, which provided the throughput measure. The unit of throughput is bits per second.
The high value of throughput means better performance. This task is tested by the TDS, keypad, mouse and the sip-and-puff device (SnP).
Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks."|24 months|||bits per second||Standard Deviation|Mean
818013|NCT01124292|Primary|Fitts' Law: Vertical Tapping Using TDS, Keypad, and Mouse (Error Rate)|"Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Vertical Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. The error rate is the rate of outside of targets vs. total targets.
Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks."|24 months|||Percentage of Missed Targets (%)||Standard Deviation|Mean
818014|NCT01124292|Primary|Fitts' Law: Vertical Tapping Using TDS, Keypad, and Mouse (Throughput)|"Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Vertical Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. This data was then fed into an equation, which provided the throughput measure. The unit of throughput is bits per second.
The high value of throughput means better performance. Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks."|24 months|||bits per second||Standard Deviation|Mean
818051|NCT01124448|Primary|Evidence of Clinically Definite Mastitis Confirmed by Microbiological Cultures and Somatic Cell Counts|Total milk bacterial count at the end of the study (after probiotic administration for 21 days), measured as log10 of the number of colony-forming units per mL of milk|one week|||log10 CFU/mL||95% Confidence Interval|Mean
834913|NCT01281202|Primary|Abstinence|The number of subjects in each treatment group who are cocaine abstinent during the last 2 weeks of the Treatment Phase (Weeks 8 and 9).|Weeks 8-9|||participants|||Number
818015|NCT01124292|Primary|Fitts' Law: Horizontal Tapping Using TDS, Keypad, and Mouse (Error Rate)|"Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Horizontal Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. The error rate is the rate of outside of targets vs. total targets.
Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks."|24 months|||Percentage of Missed Targets (%)||Standard Deviation|Mean
818016|NCT01124292|Primary|Fitts' Law: Horizontal Tapping Using TDS, Keypad, and Mouse (Throughput)|"Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Horizontal Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. This data was then fed into an equation, which provided the throughput measure. The unit of throughput is bits per second.
The high value of throughput means better performance. Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks."|24 months|||bits per second||Standard Deviation|Mean
818017|NCT01124305|Secondary|Limb Alignment (Mechanical Axis)|"Alignment is measured on 4 month postoperative radiograph in degrees. The goal is a mechanical axis between and femur and tibia of 0 degrees. Varus alignment (bow-legged) is shown as a negative number in degrees away from 0. Valgus alignment (Knock-kneed) is expressed as a positive number in degrees away from 0."|4 months|All participants were x-rayed postoperatively to measure the mechanical axis of the leg in degrees.||degrees varus(-) or valgus(+)||Full Range|Mean
818018|NCT01124305|Secondary|Number of Instrument Trays Required||1 day|per protocol||number of trays||Standard Deviation|Mean
818019|NCT01124305|Secondary|Length of Each Surgical Step (in Seconds)|surgical exposure, tibial alignment and resection, femoral distal cut, extension gap balancing, sizing the femur, 4 finishing femoral cuts, posterior releases, patellar resection, trial components, tibial tray preparation, cleanup/ prep for cement, cementing femur, cementing tibia, cementing patella, and closure|1 day|per protocol||seconds||Standard Deviation|Mean
818020|NCT01124305|Primary|Length of Surgery|Time elapsed from skin incision to wound closure (in seconds)|1 day|per protocol||seconds||Standard Deviation|Mean
818021|NCT01124370|Secondary|NYHA Functional Class Improvement From Baseline to 6 Months|"Shift in NYHA Class from baseline to 6 months NYHA Class I - Patients with cardiac disease but without resulting limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea or anginal pain.
NYHA Class II - Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea or anginal pain.
NYHA Class III - Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea or anginal pain.
NYHA Class IV - Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present event at rest. If any physical activity is undertaken, discomfort increases."|Baseline and 6 months on therapy|Heart failure subjects with 6 month data.||participants|||Number
818022|NCT01124370|Secondary|Six-minute Hall Walk Test Change From Baseline at 6 Months|Change = Month 6 score - Baseline score|Baseline and 6 months on therapy|Subjects with baseline and 6 month data.||meters||Standard Deviation|Mean
818023|NCT01124370|Secondary|Heart Failure Clinical Composite|"The composite is determined according to the following definitions.
Worsened: subject died; was hospitalized due to or associated with worsening HF; demonstrated worsening in NYHA class at last observation carried forward; moderate-marked worsening of patient global assessment score at last observation carried forward; or permanently discontinued therapy from the remedē System due to or associated with worsening HF.
Improved: subject did not worsen (as defined above) and demonstrated improvement in NYHA class at last observation carried forward or moderate-marked improvement in patient global assessment score at last observation carried forward.
Unchanged: patient was neither improved nor worsened."|6 months on therapy|Evaluable subjects with heart failure at baseline.||participants|||Number
818024|NCT01124370|Secondary|Minnesota Living With Heart Failure Questionnaire Change From Baseline at 6 Months|Change = Month 6 score - Baseline score This questionnaire was for the N=46 patients diagnosed with heart failure. Scores can range from 0-105, with lower scores indicating better quality of life.|Baseline and 6 months on therapy|Heart failure subjects with baseline and 6 month results.||units on a scale||Standard Deviation|Mean
818025|NCT01124370|Secondary|Epworth Sleepiness Scale Change From Baseline at 6 Months|Change = Month 6 score - Baseline score The ESS is an assessment to measure a subject's general level of daytime sleepiness. Scores can range from 0-24, with higher scores indicating higher level of daytime sleepiness.|Baseline and 6 months on therapy|Subjects with baseline and 6 month data.||units on a scale||Standard Deviation|Mean
818026|NCT01124370|Secondary|Related Adverse Events|The number of subjects with a serious adverse event (SAE) considered related to the remedē system or implant procedure is provided. The number of subjects with a non-SAE related to the remedē system or implant procedure is also provided. Events are included if they occurred on or after the initial implant date through 2 years post implant. A subject may have both SAE and non-SAE events, so the participants with serious events cannot be added to the non-serious participants to get the total number of participants experiencing a related event.|Up to 2 years|Subjects with an implant attempt.||participants|||Number
818027|NCT01124370|Primary|AHI Change From Baseline at 3 Months|Change = Month 3 score - Baseline score The Apnea-Hypopnea Index (AHI) is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep.|Baseline and 3 months on therapy|The evaluable population includes subjects who completed a 3 Month post therapy initiation visit.||events/hour||Standard Deviation|Mean
818052|NCT01124604|Other Pre-specified|Serum Concentration of Tapentadol||Week 2, 4, 8, 12|Pharmacokinetic analysis set included all participants who received at least 1 dose of study drug and had at least 1 serum study drug concentration. 'N’ (number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies those participants who were evaluable for this measure at given time points.||nanogram per milliliter||Standard Deviation|Mean
818028|NCT01124422|Secondary|Baseline Dyspnea Index (BDI) at Week 4 and Transition Dyspnea Index (TDI) at Week 8|The BDI-TDI is a multidimensional dyspnea measurement. The BDI, administered at Week 4, consisted of 3 items (functional impairment, magnitude of task in exertional capacity, and magnitude of effort) requiring recall over the previous 4 weeks. BDI scores ranged from 0 (very severe impairment) to 4 (no impairment); the summed total score = 0 to 12. The TDI, administered at Week 8 as a follow-up of the BDI, consisted of the same 3 items requiring recall over the previous 4 weeks. TDI scores ranged from -3 (major deterioration) to +3 (major improvement); the summed total score = -9 to 9.|BDI: Week 4; TDI: Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed.||Scores on a scale||Standard Error|Mean
818029|NCT01124422|Secondary|Mean Change in Scores on the Chronic Respiratory Disease Questionnaire Self-Administered Standardized (CRQ-SAS) Questionnaire From Week 4 to Week 8|The CRQ-SAS, a self-administered tool used to assess health-related quality-of-life (HRQOL), consists of 20 questions (q.) in 4 domains: Dyspnea (5 q.), Fatigue (4 q.), Emotional Function (7 q.), and Mastery (4 q.). Participants rated their experience on a 7-point scale in response to each q.: 1 (maximum impairment) to 7 (no impairment); higher scores indicate better HRQOL. Individual q. were equally weighted, and domain scores (range=1-7) were calculated as the mean across the non-missing items within each domain (domain scores were calculated although an individual item score was missing).|Week 4 and Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed.||Scores on a scale||Standard Error|Mean
818030|NCT01124422|Secondary|Mean Change in EIC at 2 to 3.5 Minutes During the Exercise Period From Baseline (Week 3) to Week 8|The EIC was measured at 2 to 3.5 minutes during the exercise period. Change from Baseline in EIC was calculated as the value at Week 8 minus the value at Baseline.|Baseline (Week 3) and Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed.||mL||Standard Error|Mean
818031|NCT01124422|Secondary|Mean Change in Ratio of Respiratory Rate (RR) to Tidal Volume (VT) or RR/VT at Isotime During the Course of the ESWT From Baseline to Week 8|The RR and VT of the participants at isotime were measured during the ESWT using the OMS. The ratio of RR per VT (value of RR divided by value of VT) at isotime was calculated. Change from Baseline in RR/VT at isotime was calculated as the value at Week 8 minus the value at Baseline.|Baseline (Week 3) and Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed.||breaths/min/L||Standard Error|Mean
818032|NCT01124422|Secondary|Mean Change in HR Per Time Slope During the Course of the ESWT Using Pulse Oximetry From Baseline to Week 8 (Non-OMS Subgroup)|HR was measured during the course of the ESWT in the non-OMS subgroup using pulse oximetry. The HR per time slope was calculated for each participant by fitting a linear regression line to the HR recorded for each participant during the ESWT. HR per time slope results were compared between treatment groups as means of these regression lines. Change from Baseline in HR was calculated as the value at Week 8 minus the value at Baseline.|Baseline (Week 3) and Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed. A subgroup of participants specified sites provided cardio-respiratory and exercise IC measurements with the Oxycon Mobile System (OMS). Participants not at these sites formed the non-OMS subgroup.||bpm/min||Standard Error|Mean
818033|NCT01124422|Secondary|Mean Change in Tidal Volume (VT) at Isotime During the Course of the ESWT From Baseline to Week 8|VT is defined as the lung volume representing the normal volume of air displaced between normal inspiration and expiration when extra effort is not applied. The normal value is approximately 500 mL or 7 mL/kg body weight. The VT of the participants at isotime was measured during the ESWT using the OMS. Change from Baseline in VT at isotime was calculated as the value at Week 8 minus the value at Baseline.|Baseline (Week 3) and Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed.||L||Standard Error|Mean
818034|NCT01124422|Secondary|Mean Change in Tidal Volume (VT) Per Time Slope During the Course of the ESWT From Baseline to Week 8|VT is the lung volume representing the normal volume of air displaced between normal inspiration and expiration when extra effort is not applied (normal value is approximately 500 mL or 7 mL/kg body weight). VT was measured during the ESWT using the OMS, consisting of volume transducer O2 and CO2 sensors and allowing breath-by-breath measurement of pulmonary gas exchange parameters. The participant's VT per time slope was calculated by fitting a linear regression line (RL) to their VT during the ESWT. VT per time slope results were compared between treatment groups as means of these RLs.|Baseline (Week 3) and Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed.||L/min||Standard Error|Mean
818035|NCT01124422|Secondary|Mean Change in Respiratory Rate (RR) at Isotime During the Course of the ESWT From Baseline to Week 8|RR is defined as the number of breaths taken within a set amount of time (typically within 60 secs). The RR of the participants at isotime was measured during the ESWT using the OMS. Change from Baseline in RR at isotime was calculated as the value at Week 8 minus the value at Baseline.|Baseline (Week 3) and Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed.||breaths/min||Standard Error|Mean
818036|NCT01124422|Secondary|Mean Change in Respiratory Rate (RR) Per Time Slope During the Course of the ESWT From Baseline (Week 3) to Week 8|RR is defined as the number of breaths taken within a set amount of time (typically within 60 secs). The RR of the participants was measured during the ESWT using the OMS. The system consisted of volume transducer oxygen and carbon dioxide sensors and allowed breath-by-breath measurement of pulmonary gas exchange parameters. The RR per time slope was calculated for each participant by fitting a linear regression line to the RR recorded for each participant during the ESWT. RR per time slope results were compared between treatment groups as means of these regression lines.|Baseline (Week 3) and Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed.||breaths/min/min||Standard Error|Mean
818037|NCT01124422|Secondary|Mean Change in Respiratory Exchange Ratio (RER) Per Time Slope During the Course of the ESWT From Baseline to Week 8|The respiratory exchange ratio was calculated as the ratio of VCO2 and VO2. The ratio of the amount of carbon dioxide and oxygen in the hemoglobin of the participants was measured during the ESWT using the OMS. The system consisted of oxygen and carbon dioxide sensors and allowed breath-by-breath measurement of pulmonary gas exchange parameters. Change from Baseline in RER was calculated as the value at Week 8 minus the value at Baseline.|Baseline (Week 3) and Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed.||Ratio of VCO2 and VO2||Standard Error|Mean
818038|NCT01124422|Secondary|Mean Change in Heart Rate (HR) Per Time Slope During the Course of the ESWT From Baseline (Week 3) to Week 8|HR is defined as the number of heartbeats per unit of time, typically expressed as beats per minute (bpm). It was measured during the ESWT using the OMS. The HR was collected in units of bpm and then regressed over the conduct of the exercise test measured in minutes. The HR per time slope was calculated for each participant by fitting a linear regression line to the HR recorded for each participant during the exercise test. HR per time slope results were compared between treatment groups as means of these regression lines.|Baseline (Week 3) and Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed.||bpm/min||Standard Error|Mean
818039|NCT01124422|Secondary|Mean Change in Minute Ventilation (V'E) Per Time Slope During the Course of the ESWT From Baseline (Week 3) to Week 8|The V'E was measured in the participants during the ESWT using the OMS. The system consisted of a volume transducer, oxygen sensor, and carbon dioxide sensor and allowed breath-by-breath measurement of pulmonary gas exchange parameters. The V'E was collected in liters and then regressed over the conduct of the exercise test measured in minutes. The V'E per time slope was calculated for each participant by fitting a linear regression line to the V'E recorded for each participant during the ESWT. V'E per time slope results were compared between treatment groups as means of the regression lines.|Baseline (Week 3) and Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed.||Liter (L)/min||Standard Error|Mean
818040|NCT01124422|Secondary|Mean Change in Flow of Carbon Dioxide (V'CO2) Per Time Slope During the Course of the ESWT From Baseline (Week 3) to Week 8|The amount of CO2 in the hemoglobin of the participants was measured during the ESWT using the OMS. The system consisted of a carbon dioxide sensor and allowed breath-by-breath measurement of pulmonary gas exchange parameters. The V'CO2 per time slope was calculated for each participant by fitting a linear regression line to the V'CO2 recorded for each participant during the ESWT. V'CO2 per time slope results were compared between treatment groups as means of these regression lines. Change from Baseline in V'CO2 per time slope was calculated as the value at Week 8 minus the value at Baseline.|Baseline (Week 3) and Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed.||mL/min||Standard Error|Mean
818041|NCT01124422|Secondary|Mean Change in Flow of Oxygen (V'O2) Per Time Slope During the Course of the ESWT From Baseline (Week 3) to Week 8|The V'O2 was measured during the ESWT using the Oxycon Mobile System (OMS), a portable telemetric monitoring system consisting of an oxygen sensor allowing for breath-by-breath measurement of gas exchange parameters in the lungs. The V'O2 was collected in units of mL and then regressed over the conduct of the exercise test measured in minutes. The V'O2 per time slope was calculated for each participant (par.) by fitting a linear regression line to the V'O2 recorded for each par. during the ESWT. V'O2 per time slope results were compared between treatment groups as means of these regression lin|Baseline (Week 3) and Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed.||mL/minute (min)||Standard Error|Mean
818042|NCT01124422|Secondary|Mean Change in Exercise Inspiratory Capacity (EIC) at the End of Exercise From Baseline (Week 3) to Week 8|EIC is the volume of gas that can be taken into the lungs in a full inhalation during exercise. Participants were asked to undergo the IC test every 2 minutes during exercise and at the end of the exercise, to follow changes in operational lung volumes that occured in association with exercise. Change from Baseline in EIC was calculated as the value at the end of exercise at Week 8 minus the value at the end of exercise at Baseline.|Baseline (Week 3) and Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed.||mL||Standard Error|Mean
818043|NCT01124422|Secondary|Mean Change in Pre-dose and Post-dose Resting Inspiratory Capacity (IC) From Baseline (Week 4) to Week 8|Resting IC is the volume of gas that can be taken into the lungs in a full inhalation at the resting position. The resting IC was measured before and after dosing. Change from Baseline in pre-dose resting IC was calculated as the pre-dose value at Week 8 minus the pre-dose value at Week 4. Change from Baseline in post-dose resting IC was calculated as the post-dose value at Week 8 minus the pre-dose value at Week 4.|Baseline (Week 4) and Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed.||Milliliters (mL)||Standard Error|Mean
818044|NCT01124422|Secondary|Mean Change in EDS at Isotime From Baseline (Week 3) to Week 8|EDS at isotime (last common time point for an exercise assessment [i.e., last Borg score time point of the shortest exercise test for each participant]) was assessed using a 10-point modified Borg scale. Change from Baseline in EDS at isotime was calculated as the value at Week 8 minus the value at Baseline.|Baseline (Week 3) and Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed.||Scores on a scale||Standard Error|Mean
818045|NCT01124422|Secondary|Mean Change in Scores on the Exercise Dyspnea Scale (EDS) From Baseline (Week 3) to Week 8|EDS is used to measure the level of breathlessness due to exercise, assessed using a 10-point modified Borg scale at 2-minute intervals during the ESWT: 0=no difficulty in breathing at all, 10=maximal breathing difficulty (BD). The participant pointed to the level on the scale correlating with his BD, and the local study coordinator confirmed that level verbally to him. Change from Baseline was calculated as the value at Week 8 minus the value at Baseline. A dyspnea score/time slope was calculated by fitting a linear regression line to the dyspnea scores reported during the exercise tests.|Baseline (Week 3) and Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed.||Scores on a scale/minute||Standard Error|Mean
818046|NCT01124422|Primary|Mean Change in Exercise Endurance Time (EET) From Baseline (Week 3) to Week 8|EET is defined as the time taken by a participant to exert himself during an exercise. EET was calculated based on the Endurance Shuttle Walk test (ESWT). The ESWT is a standardized, externally controlled, constant-paced field test for the assessment of endurance capacity in participants with chronic lung disease. Change from Baseline in EET was calculated as the value at Week 8 minus the value at Baseline.|Baseline (Week 3) and Week 8|Intent-to-Treat (ITT) Population: all participants randomized to study drug. Only those participants contributing data at the indicated time points were analyzed.||Seconds (sec)||Standard Error|Mean
818047|NCT01124448|Secondary|Evidence of Changes in the Immunological Profile of Milk||one year||||||
818048|NCT01124448|Secondary|Evidence of Changes in the Macronutrient and Electrolyte Profiles of Milk||One year||||||
818049|NCT01124448|Secondary|Evidence of Changes in the Metabolic Profile of Urine||One year||||||
818050|NCT01124448|Secondary|Evidence of Changes in Gene Expression of Somatic Cells Obtained From Milk Samples||one year||||||
818054|NCT01124604|Secondary|Change From Baseline in Roland Morris Disability Questionnaire (RDQ) Score at Week 12|RDQ scale is used to assess the impact of low back pain on daily activities by participants. The scale consists of 24 item questionnaire with options as “Yes”/“No” where “Yes” is counted as 1 point. The total score ranged from 0 to 24, with higher scores indicating greater disability.|Baseline, Week 12|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data. ‘N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points.||Units on a scale||Standard Deviation|Mean
818055|NCT01124604|Secondary|Change From Baseline in Western Ontario MacMaster Questionnaire (WOMAC) Global Score at Week 12|WOMAC is a self administered 24-item questionnaire used to evaluate participants with osteoarthritis of the knee. It consists of 3 subscales: pain (5 items), joint stiffness (2 items), and physical function (17 items). Each item is assessed on a 5-point scale from 0 to 4. The global score assesses pain, disability and joint stiffness and ranges from 0 to 96. Higher scores indicate that a symptom is bothersome and physically disabling.|Baseline, Week 12|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data. ‘N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points.||Units on a scale||Standard Deviation|Mean
818056|NCT01124604|Secondary|Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12|SF-36v2 is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; role emotional, social functioning and mental health contribute to mental component; and social functioning, vitality, and general health contribute to both. All scores are based on a scale from 0 to 100, with higher scores defining more favorable health state.|Baseline, Week 12|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points.||Units on a scale||Standard Deviation|Mean
818057|NCT01124604|Secondary|Number of Participants With Response Based on Overall Quality of Sleep Questionnaire|"Overall quality of sleep was addressed by the question: Please rate the overall quality of your sleep last night” and participants could choose one of the following options: excellent, good, fair or poor."|Baseline, Week 12|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points.||Participants|||Number
818058|NCT01124604|Secondary|Number of Participants With Awakenings Based on Sleep Questionnaire|"Number of awakenings was addressed by the question: How many times did you wake up during the night?'' and lesser number signified better sleep."|Baseline, Week 12|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points.||Participants|||Number
818059|NCT01124604|Secondary|Change From Baseline in Time Slept Based on Sleep Questionnaire at Week 12|"Time slept was addressed by the question: How long did you sleep last night? and the change from Baseline in time slept was reported."|Baseline, Week 12|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||Hours||Standard Deviation|Mean
818060|NCT01124604|Secondary|Change From Baseline in Sleep Latency Based on Sleep Questionnaire at Week 12|"Sleep Latency was addressed by the question: How long after bedtime/lights out did you fall asleep last night? and the change from Baseline in sleep latency was reported. Decrease in time indicated improvement."|Baseline, Week 12|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||Minutes||Standard Deviation|Mean
818061|NCT01124604|Secondary|Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Total Score at Week 12|BPI-sf consists of 15 items (item 1 - presence of pain, item 2 - pain location, items 3 to 6 - pain severity, item 7 - status of pain treatment, item 8 - efficacy of pain treatment, and items 9a to 9g - interference of pain with daily life). Total score is defined as the mean scores from items 3, 4, 5, 6 and 9 recorded on an 11-point scale where 0 = no pain and 10 = pain as bad as you can imagine. Negative change indicates an improvement in pain.|Baseline, Week 12|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points.||Units on a scale||Standard Deviation|Mean
818062|NCT01124604|Secondary|Number of Participants With 50 Percent Pain Relief Based on Brief Pain Inventory-Short Form (BPI-sf) Scale|BPI-sf is a self-evaluated pain assessment form consisting of 15 items (item 1 - presence of pain, item 2 - pain location, items 3 to 6 - pain severity, item 7 - status of pain treatment, item 8 - efficacy of pain treatment, and items 9a to 9g - interference of pain with daily life). Item 8 for efficacy of pain treatment assesses number of participants with at least 50 percent pain relief during the last 24 hours on a scale ranging from 0 percent (no relief) to 100 percent (complete relief).|Baseline, Week 12|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points.||Participants|||Number
818063|NCT01124604|Secondary|Number of Participants With Presence of Pain Based on Brief Pain Inventory-Short Form (BPI-sf) Scale|BPI-sf is a self-evaluated pain assessment form consisting of 15 items (item 1 - presence of pain, item 2 - pain location, items 3 to 6 - pain severity, item 7 - status of pain treatment, item 8 - efficacy of pain treatment, and items 9a to 9g - interference of pain with daily life). Item 1 for presence of pain assesses the question: “Do you have any pain today other than everyday kinds of pain?” on a 2-point scale of “yes” or “no”.|Baseline, Week 12|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points.||Participants|||Number
818064|NCT01124604|Secondary|Number of Participants With Response Based on Physician’s Global Assessment Scale|"Physician's Global Assessment Scale assesses the therapeutic efficacy (effectiveness) of the study drug for pain control on a 2-point scale of effective and not effective."|Week 8, Week 12|FAS included all participants who received study drug and had post-randomization efficacy data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points.||Participants|||Number
818065|NCT01124604|Secondary|Number of Participants With Categorical Scores on Patient’s Global Impression of Change (PGIC) Scale|The PGIC is a 7-point scale that requires the participants to assess how much their illness has improved or worsened relative to a Baseline state at the beginning of the intervention. The response options are 1 = very much improved, 2 = much improved, 3 = minimally improve, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.|Week 8, Week 12|FAS included all participants who received study drug and had post-randomization efficacy data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points.||Participants|||Number
818066|NCT01124604|Secondary|Percentage of Participants With Response Based on 11-point Numerical Rating Scale (NRS)|Percentage of participants with improvement in mean NRS score by greater than or equal to 30 percent or 50 percent in the last week from Baseline were considered as responders. Participants were asked to assess the average pain intensity on a 11-point NRS ranging from 0 (no pain) to 10 (maximum pain imaginable) by selecting a number applicable to their pain on the scale.|Week 12|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data.||Percentage of participants||95% Confidence Interval|Number
818067|NCT01124604|Secondary|Change From Baseline in 11-point Numerical Rating Scale (NRS)|Participants were asked to assess the average pain intensity on a 11-point NRS ranging from 0 (no pain) to 10 (maximum pain imaginable) by selecting a number applicable to their pain on the scale. The mean pain intensity during the past 74 hours (3 days) was evaluated at Baseline and the mean pain intensity during the past 12 hours was evaluated at subsequent study visits.|Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data. LOCF method was used to impute missing values.||Units on a scale||Standard Deviation|Mean
818068|NCT01124604|Primary|Change From Baseline in 11-point Numerical Rating Scale (NRS) at Week 12|Participants were asked to assess the average pain intensity on a 11-point NRS ranging from 0 (no pain) to 10 (maximum pain imaginable) by selecting a number applicable to their pain on the scale. The mean pain intensity during the past 74 hours (3 days) was evaluated at Baseline and the mean pain intensity during the past 12 hours was evaluated at subsequent study visits.|Baseline, Week 12|Full Analysis Set (FAS) included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data. Last observation carried forward (LOCF) method was used to impute missing values.||Units on a scale||Standard Deviation|Mean
818069|NCT01124617|Secondary|Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12|The SF-36v2 is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; role emotional, social functioning and mental health contribute to mental component; and social functioning, vitality, and general health contribute to both. All scores are based on a scale from 0 to 100, with higher scores defining more favorable health state.|Baseline and Week 12|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had at least 1 post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points.||Units on a scale||Standard Deviation|Mean
818070|NCT01124617|Secondary|Number of Participants With Response Based on Overall Quality of Sleep Questionnaire|Participants rated the overall quality of sleep last night as excellent, good, fair and poor.|Baseline and Week 12|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had at least 1 post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points.||Participants|||Number
818071|NCT01124617|Secondary|Number of Participants With Awakenings Based on Sleep Questionnaire|"Number of awakenings was related to How many times did the participant wake up during the night”. Lesser number signifies better sleep."|Baseline and Week 12|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had at least 1 post-randomization efficacy data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points.||Participants|||Number
818072|NCT01124617|Secondary|Change From Baseline in Time Slept Based on Sleep Questionnaire at Week 12|"Time slept was related to How long did the participant sleep last night. The mean change for the time in hours slept during the last night was reported."|Baseline and Week 12|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had at least 1 post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points.||Hours||Standard Deviation|Mean
818073|NCT01124617|Secondary|Change From Baseline in Sleep Latency Based on Sleep Questionnaire at Week 12|"Sleep Latency was related to “How long after bedtime or lights out did the participant fall asleep last night . Decrease in time indicates an improvement."|Baseline and Week 12|FAS included all participants who received study drug & had at least 1 post-randomization efficacy data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure & 'n' signifies those participants who were evaluable for this measure at given time points.||Minutes||Standard Deviation|Mean
818086|NCT01124643|Secondary|Change From Baseline in New York Heart Association (NYHA) Functional Class|"Class I: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea.
Class II: Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea.
Class III: Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea.
Class IV: Unable to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. If any physical activity is undertaken, discomfort is increased."|Baseline to 12 months|ITT population.||participants|||Number
818074|NCT01124617|Secondary|Change From Baseline in Brief Pain Inventory (Short Form) (BPI-sf) Total Score at Week 12|The BPI-sf consists of 15 Items (Item 1:presence of pain; Item 2:pain location; Items 3 to 6:pain severity; Item 7:status of pain treatment; Item 8:efficacy of pain treatment; and Items 9a to 9g: interference of pain with daily life). Total score is defined as the mean scores from Items 3, 4, 5, 6 and 9 recorded on an 11-point scale where 0 = no pain and 10 = pain as bad as you can imagine. Lower score indicates an improvement in pain.|Baseline and Week 12|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had at least 1 post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points.||Units on a scale||Standard Deviation|Mean
818075|NCT01124617|Secondary|Change From Baseline in Pain Subscale Score Based on Brief Pain Inventory (Short Form) (BPI-sf) Scale|The BPI-sf consists of 15 Items (Item 1:presence of pain; Item 2:pain location; Items 3 to 6:pain severity; Item 7:status of pain treatment; Item 8:efficacy of pain treatment; and Items 9a to 9g: interference of pain with daily life). Pain Sub-scale score ranges from 0 (absent [no pain]) to 10 (extreme [pain as bad as you can image]). Higher scores indicates worsening. Total score is defined as the mean scores from Items 3, 4, 5, 6 and 9 recorded on an 11-point scale where 0 = no pain and 10 = pain as bad as you can imagine. Lower score indicates an improvement in pain.|Baseline and Week 12|FAS included all participants who received study drug & had at least 1 post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points.||Units on a scale||Standard Deviation|Mean
818076|NCT01124617|Secondary|Change From Baseline in Pain Interference Subscale Score Based on Brief Pain Inventory (Short Form) (BPI-sf) Scale|The BPI-sf consists of 15 Items (Item 1:presence of pain; Item 2:pain location; Items 3 to 6:pain severity; Item 7:status of pain treatment; Item 8:efficacy of pain treatment; and Items 9a to 9g: interference of pain with daily life). Pain interference sub-scale score ranges from 0 (do not interfere) to 10 (completely interferes). Higher scores indicates worsening. Total score is defined as the mean scores from Items 3, 4, 5, 6 and 9 recorded on an 11-point scale where 0 = no pain and 10 = pain as bad as you can imagine. Lower score indicates an improvement in pain.|Baseline and Week 12|FAS included all participants who received study drug & had at least 1 post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points.||Units on a scale||Standard Deviation|Mean
818077|NCT01124617|Secondary|Number of Participants With Categorical Scores on Physician’s Global Assessment Scale|"Physician's Global Assessment Scale assesses the therapeutic efficacy (effectiveness) of the study drug for pain control on a 2-point scale of effective and ineffective."|Week 8 and Week 12|FAS included all participants who received study drug & had at least 1 post-randomization efficacy data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure & 'n' signifies those participants who were evaluable for this measure at given time points.||Participants|||Number
818078|NCT01124617|Secondary|Number of Participants With Categorical Scores on Patient’s Global Impression of Change (PGIC) Scale|The PGIC is a 7-point scale that requires the participants to assess how much their illness has improved or worsened relative to a Baseline state at the beginning of the intervention. The response options are 1 = very much improved, 2 = much improved, 3 = minimally improve, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.|Week 8 and Week 12|FAS included all participants who received study drug & had at least 1 post-randomization efficacy data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure & 'n' signifies those participants who were evaluable for this measure at given time points.||Participants|||Number
818079|NCT01124617|Secondary|Percentage of Participants With Treatment Response Based on Numerical Rating Scale (NRS)|Percentage of participants with treatment response in mean NRS score by greater than equal to 30 or 50 percent (%) in the last week from baseline were considered as responders. Participants were asked to assess the average pain intensity on an 11-point NRS ranging from 0 (no pain) to 10 (maximum pain imaginable) by selecting a number applicable to their pain on the scale.|Week 12|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had at least 1 post-randomization efficacy data.||Percentage of participants|||Number
818080|NCT01124617|Secondary|Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 1 to 11|Participants were asked to assess the average pain intensity on an 11-point NRS ranging from 0 (no pain) to 10 (maximum pain imaginable) by selecting a number on the scale applicable to their pain. Baseline pain score is defined as the average pain intensity score over the last 3 days prior to the randomization. Change from Baseline in NRS score is the mean NRS score at corresponding week minus mean NRS score at Baseline.|Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had at least 1 post-randomization efficacy data.||Units on a scale||Standard Deviation|Mean
818081|NCT01124617|Primary|Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 12|Participants were asked to assess the average pain intensity on an 11-point NRS ranging from 0 (no pain) to 10 (maximum pain imaginable) by selecting a number on the scale applicable to their pain. Baseline pain score is defined as the average pain intensity score over the last 3 days prior to the randomization. Change from Baseline in NRS score is the mean NRS score at Week 12 minus mean NRS score at Baseline.|Baseline and Week 12|Full Analysis Set (FAS) included all the randomly assigned participants who received at least 1 dose of study drug and had at least 1 post-randomization efficacy data. Last observation carried forward (LOCF) method was used to impute missing values.||Units on a scale||Standard Deviation|Mean
818082|NCT01124643|Primary|Safety Evaluations||Baseline to 12 months|ITT population||participants|||Number
818083|NCT01124643|Secondary|Change From Baseline in Albumin/Creatinine (A/Cr) Ratio||Baseline to 12 months|ITT population. Number of participants analyzed signifies participants evaluable for this endpoint.||Ratio||Standard Deviation|Mean
818084|NCT01124643|Secondary|Change From Baseline in eGFR||Baseline to 12 months|ITT population. Number of participants analyzed signifies participants evaluable for this endpoint.||(mL/min/1.73m^2)||Standard Deviation|Mean
818085|NCT01124643|Secondary|Change From Baseline in Plasma Gb3||Baseline to 12 months|ITT population. Number of participants analyzed signifies participants evaluable for this endpoint.||(nmol/mL)||Standard Deviation|Mean
818126|NCT01125098|Secondary|Cost/Effectiveness of the Use of PRO-CT-guided Decision Making Protocol on Duration of Antibiotic Therapy in COPD Exacerbations.||Discharge /10 days-6 months||||||
818087|NCT01124643|Secondary|Change From Baseline in the Minnesota Living With Heart Failure Questionnaire (MLHF- Q)|The MLHF-Q contains 21 questions with answers ranging from 0 (no) to 5 (very much). The final score ( 0 to 105) is the sum of the points for the 21 questions. A higher score indicates a worse quality of life.|Baseline to 12 months|ITT population. Number of participants analyzed signifies participants evaluable for this endpoint.||units on a scale||Standard Deviation|Mean
818088|NCT01124643|Secondary|Change From Baseline in Distance Walked in 6- Minute Walk Test (6MWT)||Baseline to 12 months|ITT population. Test was not done or test was not valid for all participants.||meters||Standard Deviation|Mean
818089|NCT01124643|Secondary|Change From Baseline in Maximal Oxygen Consumption (VO2max) at Peak Exercise||Baseline to 12 months|ITT population. Test was not done or test was not valid for all participants.||(mL/min/kg)||Standard Deviation|Mean
818090|NCT01124643|Primary|Change From Baseline in Left Ventricular Mass Indexed to Height (LVMI)||Baseline to 12 months|The Intent-to-Treat (ITT) participant population in this study was defined as all participants who provided informed consent and received study drug. Participants who did not have left ventricular hypertrophy were not included in this analysis.||g/m^2.7||Standard Deviation|Mean
818091|NCT01124786|Secondary|Pharmacokinetic (PK) Profile of CO-1.01 Based on Sparse Sampling||30 days after first dose|Due to Primary endpoint showing lack of efficacy, development of CO-1.01 was stopped and secondary endpoints were not analyzed.|||||
818092|NCT01124786|Secondary|Change From Baseline in Health Status||Every 4 weeks, up to 1.5 years|Due to Primary endpoint showing lack of efficacy, development of CO-1.01 was stopped and secondary endpoints were not analyzed.|||||
818093|NCT01124786|Secondary|Change From Baseline in Pain Severity||Every 4 weeks, up to 1.5 years|Due to Primary endpoint showing lack of efficacy, development of CO-1.01 was stopped and secondary endpoints were not analyzed.|||||
818094|NCT01124786|Secondary|Drug Tolerability and Toxicity||Every week, up to 1.5 years|Due to Primary endpoint showing lack of efficacy, development of CO-1.01 was stopped and secondary endpoints were not analyzed.|||||
818095|NCT01124786|Secondary|Cancer Antigen (CA)19-9 Response Rates||Every 4 weeks, up to 1.5 years|Due to Primary endpoint showing lack of efficacy, development of CO-1.01 was stopped and secondary endpoints were not analyzed.|||||
818096|NCT01124786|Secondary|ORR, Duration of Response, and Progression Free Survival (PFS) in Patients With Measurable/Evaluable Disease, Using RECIST 1.1, up to 1.5 Years||Every 8 weeks|Due to Primary endpoint showing lack of efficacy, development of CO-1.01 was stopped and secondary endpoints were not analyzed.|||||
818097|NCT01124786|Secondary|Overall Survival in All Patients and Patients With hENT1 Expression||Monthly follow up after treatment discontinuation until death, up to 1.5 years|Due to Primary endpoint showing lack of efficacy, development of CO-1.01 was stopped and secondary endpoints were not analyzed.|||||
818098|NCT01124786|Primary|Overall Survival in Patients With Low High Human Equilibrative Nucleoside Transporter 1 (hENT1) Expression||Monthly follow up after treatment discontinuation until death, up to 1.5 years.|Analysis was per protocol and included hENT-1 low Intent to Treat (IIT) population.||months||95% Confidence Interval|Median
818099|NCT01124838|Secondary|Change in VFQ-25 Subscore Ocular Pain From Baseline to the Final/Early Termination Visit|"The National Eye Institute VFQ-25 is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning.
The VFQ-25 consists of a base set of 25 vision-targeted questions plus an additional single-item general health rating question. The ocular pain subscore is calculated form the answers to 2 eye pain questions and ranges from 0 to 100, where higher scores or increases in score indicate less pain."|Baseline and Final/Early Termination Visit (up 80 weeks)|Intent-to-treat population with a Baseline and at least one post-baseline value; last observation carried forward (LOCF) imputation was used.||units on a scale||Standard Deviation|Mean
818100|NCT01124838|Secondary|Change in VFQ-25 Subscore Near Vision From Baseline to the Final/Early Termination Visit|"The National Eye Institute VFQ-25 is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning.
The VFQ-25 consists of a base set of 25 vision-targeted questions plus an additional single-item general health rating question. The near vision subscore is calculated from the answers to 3 near vision-related questions and ranges from 0 to 100, where higher scores or increases in score indicate better vision-related functioning."|Baseline and Final/Early Termination Visit (up 80 weeks)|Intent-to-treat population with a Baseline and at least one post-baseline value; last observation carried forward (LOCF) imputation was used.||units on a scale||Standard Deviation|Mean
818101|NCT01124838|Secondary|Change in VFQ-25 Subscore Distance Vision From Baseline to the Final/Early Termination Visit|"The National Eye Institute VFQ-25 is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning.
The VFQ-25 consists of a base set of 25 vision-targeted questions plus an additional single-item general health rating question. The distance vision subscore is calculated from the answers to 3 distance vision-related questions and ranges from 0 to 100, where higher scores or increases in score indicate better vision-related functioning."|Baseline and Final/Early Termination Visit (up 80 weeks)|Intent-to-treat population with a Baseline and at least one post-baseline value; last observation carried forward (LOCF) imputation was used.||units on a scale||Standard Deviation|Mean
818102|NCT01124838|Secondary|Change in Visual Functioning Questionnaire 25 (VFQ-25) Total Score From Baseline to the Final/Early Termination Visit|"The National Eye Institute VFQ-25 is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning.
The VFQ-25 consists of a base set of 25 vision-targeted questions plus an additional single-item general health rating question. The overall composite score ranges from 0 to 100, where higher scores or increases in score indicate better vision-related functioning."|Baseline and Final/Early Termination Visit (up 80 weeks)|Intent-to-treat population with a Baseline and at least one post-baseline value; last observation carried forward (LOCF) imputation was used.||units on a scale||Standard Deviation|Mean
836708|NCT01299961|Secondary|12 Month Change in Gray-scale Ultrasound (GSUS)|There were seven different joints in the hands and wrists evaluated to score the GSUS.|baseline, 12 months|||units on a scale||Standard Deviation|Mean
818103|NCT01124838|Secondary|Percent Change in Central Retinal Thickness in Each Eye From Baseline to the Final/Early Termination Visit.|Central retinal thickness was measured using OCT and assessed by a central reader.|Baseline and Final/Early Termination Visit (up to 80 weeks)|Intent-to-treat population with a Baseline and at least one post-baseline value; last observation carried forward (LOCF) imputation was used.||percent change||Standard Deviation|Mean
818104|NCT01124838|Secondary|Time to Optimal Coherence Tomography (OCT) Evidence of Macular Edema in At Least 1 Eye On or After Week 2|"Optical coherence tomography was performed at every visit using 1 of 3 approved machines. Images were evaluated by a central reader. Macular edema was defined as cystoid macular edema.
OCT evidence of macular edema on or after Week 2 was to be counted as an event. Dropouts due to reasons other than OCT evidence of macular edema were to be considered as censored observations at the time of dropping out."|From Baseline until the Final Visit (up to 80 weeks)|Intent to treat population with no macular edema at Baseline||months||Inter-Quartile Range|Median
818105|NCT01124838|Secondary|Change In Logarithm of the Minimum Angle of Resolution (LogMAR) Best Corrected Visual Acuity (BCVA) In Each Eye From Baseline to the Final/Early Termination Visit|Using corrective lenses based on that visit's refraction testing, participant's best corrected visual acuity was measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) logMAR chart. On the logMAR scale, 0 is equivalent to 20/20 visual acuity, the range of normal vision is considered to be from -0.2 - 0.1; higher values indicate visual impairment.|Baseline and Final/Early Termination Visit (up to 80 weeks)|Intent-to-treat population with a Baseline and at least one post-baseline value; last observation carried forward (LOCF) imputation was used.||logMAR||Standard Deviation|Mean
818106|NCT01124838|Secondary|Change in Vitreous Haze (VH) Grade in Each Eye From Baseline to the Final/Early Termination Visit|"Vitreous haze was measured using dilated indirect ophthalmoscopy (DIO) and assessed by the Investigator according to National Eye Institute (NEI) and SUN criteria:
Grade 0: No evident vitreous haze;
Grade 0.5+: Slight blurring of the optic disc margin because of the haze; normal striations and reflex of the nerve fiber layer cannot be visualized;
Grade 1+: Permits a better definition of both the optic nerve head and the retinal vessels (compared to higher grades);
Grade 2+: Permits better visualization of the retinal vessels (compared to higher grades);
Grade 3+: Permits the observer to see the optic nerve head, but the borders are quite blurry;
Grade 4+: Optic nerve head is obscured."|Baseline and Final/Early Termination Visit (up to 80 weeks)|Intent-to-treat population with a Baseline and at least one post-baseline value; last observation carried forward (LOCF) imputation was used.||units on a scale||Standard Deviation|Mean
818107|NCT01124838|Secondary|Change in Anterior Chamber (AC) Cell Grade in Each Eye From Baseline to the Final/Early Termination Visit|"Slit lamp examinations were conducted at each visit to assess AC cell count. The number of AC cells observed within a 1 mm × 1 mm slit beam was used to determine the grade according to the Standardization of Uveitis Nomenclature (SUN) criteria:
Grade 0 = < 1 cell
Grade 0.5+ = 1 - 5 cells
Grade 1+ = 6 - 15 cells
Grade 2+ = 16 - 25 cells
Grade 3+ = 26 - 50 cells
Grade 4+ = > 50 cells."|Baseline and at the Final/Early Termination Visit (up to 80 weeks)|Intent-to-treat population with a Baseline and at least one post-baseline value; last observation carried forward (LOCF) imputation was used.||units on a scale||Standard Deviation|Mean
818108|NCT01124838|Primary|Time to Treatment Failure on or After Week 2|"Treatment failure was defined by the occurrence of a uveitis flare (the inability to maintain disease control). To be considered treatment failure, ≥ 1 of these criteria had to be present in at least 1 eye at Week 2 or all other visits:
New active, inflammatory chorioretinal, and/or inflammatory retinal vascular lesions relative to Baseline
2-step increase relative to Baseline in anterior chamber cell grade or vitreous haze grade
Worsening of best corrected visual acuity by ≥ 15 letters relative to baseline.
Time to treatment failure was analyzed using the Kaplan-Meier method. Dropouts for reasons other than treatment failure at any time during the study were censored at the drop out date.
Per protocol, the primary analysis was performed in the Main Study population which included all randomized participants recruited outside Japan; for completeness results are also reported below for the Integrated dataset which includes participants recruited in Japan."|From Baseline until end of study (up to 80 weeks)|The intent-to-treat (ITT) population which included all randomized participants; 3 participants at 2 sites were excluded from the ITT due to incomplete efficacy source data and compliance issues.||months||Inter-Quartile Range|Median
818109|NCT01124864|Secondary|Pharmacokinetics (PK) of Plasma Concentration of AUY922 and Its Metabolite BJP762: Cmax|Summary of PK parameters for all patients one hour post 70 mg/m2 AUY922 infusion for concentration max. There are discrepancies between sample numbers and study population because PK samples were not collected from all study subjects and thus were not analyzed.|1 hour after infusion|PK analysis subset - All patients who received at least one dose of AUY922 in Cycle 1 and had at least one measurable post-dose AUY922 concentration.||ng/mL||Standard Deviation|Mean
818110|NCT01124864|Secondary|Pharmacokinetics (PK) of Plasma Concentration of AUY922 and Its Metabolite BJP762: AUClast|Summary of PK parameters for all patients one hour post 70 mg/m2 AUY922 infusion for area under the curve last. There are discrepancies between sample numbers and study population because PK samples were not collected from all study subjects and thus were not analyzed.|1 hour after infusion|PK analysis subset - All patients who received at least one dose of AUY922 in Cycle 1 and had at least one measurable post-dose AUY922 concentration.||h*ng/mL||Standard Deviation|Mean
818111|NCT01124864|Secondary|Pharmacokinetics (PK) of Plasma Concentration of AUY922 and Its Metabolite BJP762: AUCinf|Summary of PK parameters for all patients one hour post 70 mg/m2 AUY922 infusion for area under the curve infinity. There are discrepancies between sample numbers and study population because PK samples were not collected from all study subjects and thus were not analyzed.|1 hour after infusion|PK analysis subset - All patients who received at least one dose of AUY922 in Cycle 1 and had at least one measurable post-dose AUY922 concentration.||h*ng/mL||Standard Deviation|Mean
818127|NCT01125098|Primary|To Evaluate the Rate of Severe Exacerbations in COPD, Comparing COPD Patients Previously Treated According to the PRO-CT Protocol Versus COPD Patients Previously Treated With Standard Antibiotic Therapy.|We prospectively recruited COPD patients hospitalized for severe exacerbation of COPD and followed them after discharge. The primary end point of the study was the number of patients with at least 1 exacerbation at 6 months after the index exacerbation that was the reason for their hospital admission.|6 months|||participants|||Number
819931|NCT01139658|Secondary|Duration of Treatment||11 weeks|Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.||days||Standard Deviation|Mean
818112|NCT01124864|Secondary|Progression Free Survival (PFS) Rate as Per Investigator Using Kaplan Meier Estimates - Per Investigator Radiological Review|Progression-free survival (PFS) is the time from date of randomization/start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient did not have an event, progression-free survival was censored at the date of last adequate tumor assessment. A Novartis modified response evaluation criteria in solid tumors RECIST 1.1 criteria was applied to CT/MRI imaging data when assessing any responses to AUY922 treatment. All images were evaluated locally by the investigator. All complete or partial responses were confirmed by a second assessment at least 4 weeks later.|Week 12, Week 18|The Full Analysis Set (FAS) consisted of all patients who received at least one dose of AUY922.||Percentage of participants|||Number
818113|NCT01124864|Secondary|Overall Survival Rate Using Kaplan Meier Estimates - Per Investigator Radiological Review|Overall survival (OS) is defined as the time from date of randomization/start of treatment to date of death due to any cause. If a patient is not known to have died, survival was censored at the date of last contact.|Week 12, Week 18|The Full Analysis Set (FAS) consisted of all patients who received at least one dose of AUY922.||Percentage of participants|||Number
818114|NCT01124864|Primary|Response Assessment by Study Stratum - Per Investigator Assessment|The primary endpoint of the study was the investigator assessment of efficacy at 18 weeks in terms of response complete response (CR)/partial response (PR), stable disease (SD), or non clinical benefit (NCB) as assessed by response evaluation criteriain solid tumors (RECIST) version 1.0. ORR = patients with confirmed complete or partial response. Stable disease at 18 weeks = patients without response and with no assessment of progressive disease up to 18 weeks, but with an assessment of stable disease or better either within 2 weeks prior to the 18 week time point, or at the next non-missing assessment after the 18 week time point. No clinical benefit = all other patients.|18 weeks|The Full Analysis Set (FAS) consisted of all patients who received at least one dose of AUY922.||Participants|||Number
818115|NCT01124916|Secondary|Urinary Distress Between Standard and Robotic-assisted Laparoscopic Abdominal Sacrocolpopexy|At 6-months following surgery, the study will measure urinary distress using the Urinary Distress Inventory (UDI) and compare this estimate between women assigned to standard vs robotic-assisted laparoscopic abdominal sacrocolpopexy. The UDI measures urinary incontinence and distress and their effect on daily life. The score range is 0 to 300, with higher scores indicating worsening symptoms.|6 Months|The analysis excludes three individuals assigned to the LASC cohort and two individuals assigned to the RASC cohort because they were lost to follow-up six months after intervention.||units on a scale||Standard Deviation|Mean
818116|NCT01124916|Primary|Total Cost of Care Between Standard and Robotic-assisted Laparoscopic Abdominal Sacrocolpopexy|At 6-weeks following surgery, the study will measure the total cost of care in dollars and compare this estimate between women assigned to standard vs robotic-assisted laparoscopic abdominal sacrocolpopexy.|6 Weeks|The analysis for the primary outcome includes all randomized subjects.||Dollars||Standard Deviation|Mean
818117|NCT01124955|Secondary|Number of Anti-inflammatory Tablets Taken|Number of 50 mg sodium diclofenac pills taken per day|Days 3,7,14,21 and 28|Intention to treat (ITT)||number of pills/day||Standard Deviation|Mean
818118|NCT01124955|Secondary|Likert Improvement Assessment Scale|Likert improvement assessment scale is based on the patient’s opinion (LIKERT P) and assessor’s opinion (LIKERT A), categorized in 1=MB (much better), 2=SB (slightly better), 3=NC (no change), 4=SW (slightly worse) and 5=MW (much worse). This scale was was applied to each day of assessment. The numbers in the category titles represent the different days.|Days 0, 3, 7, 14 and 21|||scores on a scale||Standard Deviation|Mean
818119|NCT01124955|Secondary|Quality of Life Assessed on the SF-36|Questionnaire Short-form-36 is a widely used generic health status questionnaire, validated for Portuguese with eight components and each components with scores from 0 to 100: higher scores denote greater quality of life.|Days 0, 3, 7, 14, 21 and 28|Intention to treat analysis (ITT)||scores on a scale|Participants|Standard Deviation|Mean
818120|NCT01124955|Secondary|Roland-Morris Disability Questionnaire (RM)|"Secondary outcomes includes the Roland-Morris Disability Questionnaire (RM) for the assessment of functional capacity, with 24 items on low-back pain: higher scores denote poorer functional capacity.
0: better functional capacity 24: poorer functional capacity Range of score: the highest is 24 (poorer functional capacity) and lowest scores is 0 (better functional capacity)."|days 0, 3, 7, 14, 21 and 28|Intention to treat analysis (ITT)||scores on a scale|Participants|Standard Deviation|Mean
818121|NCT01124955|Primary|Pain Assessed on a 10-point Numeric Pain Scale|The primary outcome is a visual analog pain scale (VAS), graded in centimeters from 0 to 10 (0=no pain; 10=worst imaginable pain), measured before (VAS 1) and after (VAS 2) the acupuncture session.|days 0, 3, 7, 14, 21 and 28|Intention to treat analysis (ITT)||cm|Participants|Standard Deviation|Mean
818122|NCT01125098|Secondary|To Verify the Duration of Hospitalization for Severe Exacerbation in COPD Patients Treated According to the PRO-CT Protocol Versus COPD Patients Treated With Standard Antibiotic Therapy.|We evaluate the duration in days in case of hospitalization for severe COPD exacerbation in COPD patients in the study population, both in the PRO-CT-guided antibiotic treatment group and in the standard antibiotic treatment group.|Discharge/10 days-6 months||11/2014||||
818123|NCT01125098|Secondary|To Verify Changes in FEV1 Value in COPD Patients Comparing Those Treated According to the PRO-CT Protocol Versus COPD Patients Treated With Standard Antibiotic Therapy.|COPD patients of the study population will undergo spirometry on visit 1, 4, 5, 7 in order to evaluate if there is change in FEV1 among COPD patients, both in the PRO-CT Group and in the standard Group.|Discharge/10 days-6 months||11/2014||||
818124|NCT01125098|Secondary|To Verify Survival in COPD Patients Comparing to Those Treated According to the PRO-CT Protocol Versus COPD Patients Treated With Standard Antibiotic Therapy.|We evaluate the number of deaths from any cause among COPD patients in the study population, in order to compare survival among patients both in PRO-CT group and in the standard group.|Discharge/10 days-6 months||11/2014||||
818125|NCT01125098|Secondary|To Evaluate if the PRO-CT-guided Decision Making to Shorten Antibiotic Therapy is Less Effective Than the Guideline Recommended Standard Antibiotic Treatment in Preventing Hospitalization.|We evaluate the number of hospital re-admissions for severe COPD exacerbation in COPD patients of the study population, both in the PRO-CT group and in the standard group, in order to assess if shortening antibiotic therapy taking into account the values of PRO-CT is less effective compared to a standard antibiotic treatment.|Discharge/10 days-6 months||11/2014||||
818128|NCT01125189|Secondary|Percentage of Resistant Variants Associated With Virologic Failure|"Virologic failure was defined as:
Virologic breakthrough: confirmed >1 log10 increase in hepatitis C virus (HCV) RNA over nadir or confirmed RNA ≥lower limit of quantitation (LLOQ) after confirmed HCV RNA <LLOQ, target not detected (TND) while on treatment
<1 log10 decrease in HCV RNA from baseline at Week 4 of treatment
Failure to achieve early virologic response: <2 log10 decrease in HCV RNA from baseline and HCV RNA ≥LLOQ at Week 12 of treatment
HCV RNA < LLOQ, TD or ≥ LLOQ at Week 12 and ≥ LLOQ at Week 24
HCV RNA ≥LLOQ or <LLOQ, target detected (TD) at the end of treatment (EOT) (including early discontinuation)
Relapse, defined as HCV RNA ≥LLOQ or <LLOQ, TD during follow­up, after HCV RNA < LLOQ, TND at EOT.
The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. N=Number of participants analyzed for this outcome."|Follow-up Week 48|All treated participants. Here, N signifies number of participants evaluable for this outcome measure.||percentage of participants|||Number
818129|NCT01125189|Secondary|Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With 12-week Sustained Virologic Response (SVR12)|SVR12 was defined as undetectable RNA (HCV RNA < lower limit of quantitation (LLOQ), target not detected (TND) at follow-up Week 12. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. N=Number of participants analyzed for this outcome.|Follow-up Week 12|All treated participants. Here, N signifies number of participants evaluable for this outcome measure.||percentage of participants||80% Confidence Interval|Number
818130|NCT01125189|Secondary|Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Complete Early Virologic Response (cEVR)|cEVR was defined as undetectable RNA (HCV RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at Week 12. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. N=Number of participants analyzed for this outcome.|Week 12|All treated participants. Here, N signifies number of participants evaluable for this outcome measure.||percentage of participants||80% Confidence Interval|Number
818131|NCT01125189|Secondary|Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Rapid Virologic Response (RVR)|RVR was defined as undetectable RNA (HCV RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at Week 4. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. N=Number of participants analyzed for this outcome.|Week 4|All treated participants. Here, N signifies number of participants evaluable for this outcome measure.||percentage of participants||80% Confidence Interval|Number
818132|NCT01125189|Primary|Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Who Died|SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.|From start of study treatment (day 1) up to follow-up Week 48|All treated participants.||participants|||Number
818133|NCT01125189|Primary|Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Sustained Virologic Response (SVR24)|SVR24 was defined as HCV <lower limit of quantitation (LLOQ) and target not detected (TND) at follow-up Week 24. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Follow-up Week 24|All treated participants. Here, N signifies number of participants evaluable for this outcome measure.||percentage of participants||80% Confidence Interval|Number
818134|NCT01125189|Primary|Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Extended Rapid Virologic Response (eRVR)|eRVR was defined as HCV RNA <lower limit of quantitation and target not detected at both Weeks 4 and 12 on treatment.|Weeks 4 and 12|All treated participants. Here, 'number of participants' analyzed (N) signifies number of participants evaluable for this outcome measure.||percentage of participants||80% Confidence Interval|Number
818135|NCT01125202|Primary|Time Specific Change From Baseline in Dietary Sodium Intake (Baseline to 16 Weeks)|Dietary sodium intake was assessed via three 24-hour dietary recalls, including 1 dialysis weekday, 1 non-dialysis weekday, and 1 non dialysis weekend day. Recalls were entered into Nutrition Data System for Research, with sodium intake averaged across the 3 recalls.|Baseline to 16 weeks|Some participants have missing sodium data due to missed dietary recalls.||mg/day||Standard Deviation|Mean
818136|NCT01125202|Primary|Time Specific Change From Baseline in Dietary Sodium Intake (Baseline to 8 Weeks)|Dietary sodium intake was assessed via three 24-hour dietary recalls, including 1 dialysis weekday, 1 non-dialysis weekday, and 1 non dialysis weekend day. Recalls were entered into Nutrition Data System for Research, with sodium intake averaged across the 3 recalls. The difference between measurement time points was determined.|Baseline to 8 weeks|Some participants have missing sodium data due to missed dietary recalls.||mg/day||Standard Deviation|Mean
818137|NCT01125202|Primary|Time Specific Dietary Sodium Intake (16 Weeks)|Dietary sodium intake was assessed via three 24-hour dietary recalls, including 1 dialysis weekday, 1 non-dialysis weekday, and 1 non dialysis weekend day. Recalls were entered into Nutrition Data System for Research, with sodium intake averaged across the 3 recalls.|16 weeks|Some participants have missing sodium data due to missed dietary recalls.||mg/day||Standard Deviation|Mean
818138|NCT01125202|Primary|Time Specific Dietary Sodium Intake (8 Weeks)|Dietary sodium intake was assessed via three 24-hour dietary recalls, including 1 dialysis weekday, 1 non-dialysis weekday, and 1 non dialysis weekend day. Recalls were entered into Nutrition Data System for Research, with sodium intake averaged across the 3 recalls.|8 weeks|Some participants have missing sodium data due to missed dietary recalls.||mg/day||Standard Deviation|Mean
818139|NCT01125202|Primary|Time Specific Dietary Sodium Intake (Baseline)|Dietary sodium intake was assessed via three 24-hour dietary recalls, including 1 dialysis weekday, 1 non-dialysis weekday, and 1 non dialysis weekend day. Recalls were entered into Nutrition Data System for Research, with sodium intake averaged across the 3 recalls.|Baseline|Some participants have missing sodium data due to missed dietary recalls.||mg/day||Standard Deviation|Mean
818140|NCT01125202|Primary|Time Specific Interdialytic Weight Gain (16 Weeks)|Average interdialytic weight gains (kg/day) were calculated for the 1 week period prior to the 16 week measurement time point.|16 weeks|Some participants have missing interdialytic weight gains due to missed hemodialysis treatments.||kg/day||Standard Deviation|Mean
818144|NCT01125514|Primary|Diuretic Efficacy Index 2 for Water Excretion|Efficacy of furosemide for water excretion (efficacy index 2) was defined by dividing urine volume by the urinary excretion of furosemide.Diuretic index 2 for water was calculated for the 0 to 4 hour fraction and for the total 0 to 24 hour urine collection.|0 to 24 hours|All patients who received at least one dose of study drug and had evaluable PD data with no major protocol deviation in at least one period were included in the PD analysis set.||mL/mg||Standard Deviation|Mean
818145|NCT01125514|Primary|Diuretic Efficacy Index 2 for Water Excretion|Efficacy of furosemide for water excretion (efficacy index 2) was defined by dividing urine volume by the urinary excretion of furosemide.Diuretic index 2 for water was calculated for the 0 to 4 hour fraction urine collection.|0 to 4 hours|All patients who received at least one dose of study drug and had evaluable PD data with no major protocol deviation in at least one period were included in the PD analysis set.||mL/mg||Standard Deviation|Mean
818146|NCT01125514|Secondary|Mean Sitting Systolic Blood Pressure (msSBP)and Mean Sitting Diastolic Blood Pressure (msDBP)|Sitting blood pressure was measured three times at 1 to 2-minute intervals. The mean of the three sitting blood pressure measurements was used as the average of the sitting office blood pressure. The msSBP and msDBP data were analyzed using a mixed effect model with fixed effects from treatment and treatment*time; random effect from patients and predose as covariate.|0.5 hour pre-dose, 0.5, 1, 2, 4, 8, 12 and 24 hours post dose.|Safety analysis set include subjects that received study drug.||mmHg||Standard Error|Least Squares Mean
818147|NCT01125514|Secondary|Urine Sodium and Potassium Excretion Per Treatment at 24 Hours Postdose|Urine was collected 24 hours postdose in all treatment groups for sodium and potassium analysis. Each patient was required to void their bladder before drug administration and at the end 24 hours.|24 hours postdose|All patients who received at least one dose of study drug and had evaluable pharmacodynamics (PD)data with no major protocol deviation in at least one period were included in the PD analysis set.||mmol||Standard Deviation|Mean
818148|NCT01125514|Secondary|Urine Sodium and Potassium Excretion Per Treatment at 12 Hours Postdose|Urine was collected 12 hours postdose in all treatment groups for sodium and potassium analysis. Each patient was required to void their bladder before drug administration and at the end 12 hours.|12 hours postdose|All patients who received at least one dose of study drug and had evaluable pharmacodynamics (PD)data with no major protocol deviation in at least one period were included in the PD analysis set.||mmol||Standard Deviation|Mean
818149|NCT01125514|Secondary|Urine Sodium and Potassium Excretion Per Treatment at 8 Hours Postdose|Urine was collected 8 hours postdose in all treatment groups for sodium and potassium analysis. Each patient was required to void their bladder before drug administration and at the end 8 hours.|8 hours postdose|All patients who received at least one dose of study drug and had evaluable pharmacodynamics (PD)data with no major protocol deviation in at least one period were included in the PD analysis set.||mmol||Standard Deviation|Mean
818150|NCT01125514|Secondary|Urine Sodium and Potassium Excretion Per Treatment at 4 Hours Postdose|Urine was collected 4 hours postdose in all treatment groups for sodium and potassium analysis. Each patient was required to void their bladder before drug administration and at the end 4 hours.|4 hours postdose|All patients who received at least one dose of study drug and had evaluable pharmacodynamics (PD)data with no major protocol deviation in at least one period were included in the PD analysis set.||mmol||Standard Deviation|Mean
818151|NCT01125514|Secondary|Creatinine Clearance|Creatinine clearance= (Urine creatinine/Serum creatinine) x (Urine volume/(24*60)).|0 to 4, 4 to 8, 8 to 12 and 12 to 24 hours post dose|All patients who received at least one dose of study drug and had evaluable PD data with no major protocol deviation in at least one period were included in the PD analysis set.||mL/min||Standard Deviation|Mean
818152|NCT01125514|Secondary|Urine Pharmacokinetics (PK) of Furosemide: Renal Clearance (CLR)|The renal clearance of drug [volume x time-1]|0 to 4, 4 to 8, 8 to 12 and 12 to 24 hours post dose|All patients who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data with no major protocol deviation in at least one period were included in the PD analysis set.||L/h||Standard Deviation|Mean
818153|NCT01125514|Secondary|Urine Pharmacokinetics (PK) of Furosemide: Amount of Drug Excreted Into the Urine From Time Zero to 24 Hours After Administration (Ae0-24)|The area under the plasma (or serum or blood) concentration-time curve from time zero to 24 h [mass × time × volume-1]|0 to 4, 4 to 8, 8 to 12 and 12 to 24 hours post dose|All patients who received at least one dose of study drug and had evaluable PK data with no major protocol deviation in at least one period were included in the PK analysis set||mg||Standard Deviation|Mean
818154|NCT01125514|Secondary|Plasma Pharmacokinetics (PK) of Furosemide: Lowest Plasma Concentration Observed During a Dosing Interval at Steady State (Cmin, ss)|The minimum observed steady-state drug concentration in the plasma, blood, serum, or other body fluids at the end of the dosing interval during multiple dosing [amount x volume-1]|pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24 hours post dose|All patients who received at least one dose of study drug and had evaluable PK data with no major protocol deviation in at least one period were included in the PK analysis set||ng/mL||Standard Deviation|Mean
818155|NCT01125514|Secondary|Plasma Pharmacokinetics (PK) of Furosemide: Average Steady State Plasma Concentration During Multiple Dosing (Cav,ss)|The average steady-state drug concentration in the plasma, blood, serum, or other body fluids during multiple dosing [amount x volume-1]. This was estimated as AUCτ/τ|pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post dose|All subjects with evaluable pharmacokinetic parameter data with no exclusion flags and no major protocol deviations.||ng/mL||Standard Deviation|Mean
818156|NCT01125514|Secondary|Plasma Pharmacokinetics (PK) of Furosemide: Time to Reach the Maximum Concentration After Drug Administration (Tmax)|Tmax was directly determined from the raw plasma concentration-time data.|pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post dose|All patients who received at least one dose of study drug and had evaluable PK data with no major protocol deviation in at least one period were included in the PK analysis set||Hours||Full Range|Median
818157|NCT01125514|Secondary|Plasma Pharmacokinetics (PK) of Furosemide: Observed Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax, ss)|Cmax,ss was directly determined from the raw plasma concentration-time data.|pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post dose|All patients who received at least one dose of study drug and had evaluable pharmacokinetic (PK) data with no major protocol deviation in at least one period were included in the PK analysis set||ng/mL||Standard Deviation|Mean
818158|NCT01125514|Secondary|Plasma Pharmacokinetics (PK) of Furosemide: Area Under the Plasma Concentration-time Curve (AUC)|"Pharmacokinetic (PK) parameters were determined from the plasma concentration time profile of furosemide using a non-compartmental method:
AUCtau: Area under the plasma concentration-time curve from time zero to the end of the dosing interval
AUC (0-24): Area under the plasma concentration-time curve from time zero to 24 hours
AUClast: Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration. AUClast was calculated as the sum of linear trapezoids using non-compartmental analysis.
AUCinf: Area under the plasma concentration-time curve from time zero to infinity. AUCinf was calculated by adding AUClast and the value obtained from dividing the last measurable plasma concentration by λz, where λz was determined from automated linear regression of the last three time points with non-zero concentrations in the terminal phase of the log-transformed concentration-time profile"|pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post dose|All patients who received at least one dose of study drug and had evaluable Pharmacokinetic (PK) data with no major protocol deviation in at least one period were included in the PK analysis set.||h*ng/mL||Standard Deviation|Mean
818159|NCT01125514|Primary|Diuretic Efficacy Index 1 for Sodium Excretion|Efficacy of furosemide for sodium excretion (efficacy index 1) was defined by dividing urinary sodium excretion by the urinary excretion of furosemide. Diuretic index 1 for sodium was calculated for the for the total 0 to 24 hour urine collection.|0 to 24 hours|All patients who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data with no major protocol deviation in at least one period were included in the PD analysis set.||mmol/mg||Standard Deviation|Mean
818160|NCT01125514|Primary|Diuretic Efficacy Index 1 for Sodium Excretion|Efficacy of furosemide for sodium excretion (efficacy index 1) was defined by dividing urinary sodium excretion by the urinary excretion of furosemide. Diuretic index 1 for sodium was calculated for the for the total 0 to 4 hour urine collection.|0 to 4 hours|All patients who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data with no major protocol deviation in at least one period were included in the PD analysis set.||mmol/mg||Standard Deviation|Mean
818161|NCT01125566|Secondary|Overall Survival (OS)|"OS is defined as time from randomisation to death irrespective of the cause of the death.
For patients who had not died up to the cut-off date (03Sep2013), the date they were last known to be alive was derived from the patient status records, the trial completion record, radiological imaging assessments, the study treatment termination record, and the randomisation date."|From randomisation to data cut-off (03Sep2013); Up to 37 months.|Randomised set (RS): The randomised set included all patients who were randomised to receive treatment, whether treated or not||months||Inter-Quartile Range|Median
818162|NCT01125566|Secondary|Best RECIST Assessment|"Best RECIST assessment is defined as CR, PR, stable disease (SD), PD or not evaluable by investigator (RECIST version 1.1).
CR for target lesions (TL): Disappearance of all target lesions.
CR for non-target lesions (NTL): Disappearance of all non-target lesions and normalization of tumour marker level. All lymph nodes must be non-pathological in size (<10mm short axis).
PR: At least a 30% decrease in the sum of diameters (SoD) of target lesions taking as reference the baseline sum diameters.
SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as references the smallest SoD while on study.
PD: At least a 20% increase in the SoD of target lesions, taking as references the smallest sum on study (this includes the baseline sum if that is the smallest on study). Also, the sum must also demonstrate an absolute increase of a least 5mm. Appearance of one or more new lesions."|Post baseline tumour-imaging was performed at Week 8, 16, 24, 32, 40, 48, 56 and then every 12 weeks (Data collected until cut-off date 08Jun2013; Up to 34 months)|Randomised set (RS): The randomised set included all patients who were randomised to receive treatment, whether treated or not (One centre was excluded from analysis due to serious non-compliance, thus data from 5 patients in AV arm and 1 patient in TV arm were excluded)||percentage of participants|||Number
818163|NCT01125566|Secondary|Objective Response (OR)|"OR is defined as complete response (CR) and partial response (PR). Assessed by investigator according to RECIST 1.1.
Only data collected until the cut-off date 08Jun2013 were considered. Complete Response (CR) for target lesions (TL): Disappearance of all target lesions.
Complete Response (CR) for non-target lesions (NTL): Disappearance of all non-target lesions and normalization of tumour marker level. All lymph nodes must be non-pathological in size (<10mm short axis)
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters.
Other factors which add to the overall response of an imaging timepoint as PR are as below:-
CR in TL, but non-CR/Non-PD in NTL leads to PR
CR in TL, but not evaluated NTL leads to PR
PR in TL, but non-PD NTL or not all evaluated NTL leads to PR"|Post baseline tumour-imaging was performed at Week 8, 16, 24, 32, 40, 48, 56 and then every 12 weeks (Up to 34 months)|Randomised set (RS): The randomised set included all patients who were randomised to receive treatment, whether treated or not (One centre was excluded from analysis due to serious non-compliance, thus data from 5 patients in AV arm and 1 patient in TV arm were excluded)||percentage of participants||95% Confidence Interval|Number
818164|NCT01125566|Primary|Progression-free Survival (PFS)|"PFS is defined as time from randomisation to disease progression or death whichever occurs first. Assessed by investigator according to the Response Evaluation Criteria in Solid Tumours (RECIST 1.1).
Only data collected until the cut-off date for RECIST 1.1 based endpoints (08Jun2013) were considered.
Progression of disease was determined if at least 1 of the following criteria applied:
At least a 20% increase in the sum of the diameters (SoD) of target lesions taking as reference the smallest SoD recorded since the treatment started, together with an absolute increase in the SoD of at least 5 mm
Appearance of 1 or more new lesions
Unequivocal progression of existing non-target lesions"|From randomization until disease progression, death or data cut-off (08Jun2013); Up to 34 months|Randomised set (RS): The randomised set included all patients who were randomised to receive treatment, whether treated or not||months||Inter-Quartile Range|Median
818165|NCT01125605|Primary|Tolerability After Visit 2 and Visit 3|Assessment of tolerability at visit 2 and visit 3 well tolerated = no side effcts poor tolerated = side effects|appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3)|descriptive; for safety 326 patients were analysed; 1 patient had no efficacy values and were not analysed for efficacy; so a discrepancy between 325 patients (for efficacy) and 326 (for safety) occured||participants|||Number
818166|NCT01125605|Primary|Irritability/Eccentricity for Visit 1 (Baseline), Visit 2, Visit 3 and Last Observation|The severity of irritability/eccentricity was graded on a four-point scale from 0 (no complaints) to 3 (strong complaints).|begin (visit 1), appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3)|descriptive; for all partcipations with values at the visits||participants|||Number
818167|NCT01125605|Secondary|Efficacy Rating for PASCONAL® NERVENTROPFEN (Last Value) Compared to Previous Therapy by Treatment Duration|"Efficacy of the therapy with PASCONAL® NERVENTROPFEN was rated by the physician on a 4-point rating scale at Visit 2 and Visit 3. The same scale was applied at Visit 1 for evaluation of the efficacy of the previous medication.
The last evaluation for PASCONAL® NERVENTROPFEN (Visit 2 or Visit 3, according to the LOCF principle) was compared with the rating for the previous therapy by means of the categories PASCONAL® better, No difference and PASCONAL® worse."|appr. after 2 weeks (visit 2) and appr. after 4 weeks (visit 3)|exploratively, all participations with values||participants|||Number
818168|NCT01125605|Primary|Nervousness/Restlessness for Visit 1 (Baseline), Visit 2, Visit 3 and Last Obsevation|The severity of nervousness/restlessness was graded on a four-point scale from 0 (no complaints) to 3 (strong complaints).|begin (visit 1), appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3)|descriptive; for all partcipations with values at the visits||participants|||Number
818169|NCT01125605|Secondary|Efficacy Rating for PASCONAL® NERVENTROPFEN (Last Value) Compared to Previous Therapy by Concomitant Medication (Yes/no)|"Efficacy of the therapy with PASCONAL® NERVENTROPFEN was rated by the physician on a 4-point rating scale at Visit 2 and Visit 3. The same scale was applied at Visit 1 for evaluation of the efficacy of the previous medication.
The last evaluation for PASCONAL® NERVENTROPFEN (Visit 2 or Visit 3, according to the LOCF principle) was compared with the rating for the previous therapy by means of the categories “PASCONAL® better”, “No difference” and “PASCONAL® worse”."|appr. after 2 weeks (visit 2) and appr. after 4 weeks (visit 3)|exploratively, all participations with values||participants|||Number
818170|NCT01125605|Secondary|Direction of Change of Symptom Irritability/Eccentricity Between Baseline and Last Observation by Duration of Treatment|"The symptom irritability/eccentricity was analysed with respect to the direction of change between baseline (Visit 1) and the last documented visit (Visit 2 or Visit 3) by means of the categories improved, unchanged and worsened. For each symptom patients were included in the analysis only if the symptom had been present at Visit 1 (i.e. the baseline score value was > 0)."|begin (visit 1) and last observation (appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3))|exploratively, all participations with values||participants|||Number
818171|NCT01125605|Secondary|Direction of Change of Symptom Irritability/Eccentricity Between Baseline and Last Observation by Concomitant Medication|"The symptom irritability/eccentricity was analysed with respect to the direction of change between baseline (Visit 1) and the last documented visit (Visit 2 or Visit 3) by means of the categories improved, unchanged and worsened. For each symptom patients were included in the analysis only if the symptom had been present at Visit 1 (i.e. the baseline score value was > 0)."|begin (visit 1) and last observation (could be appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3))|exploratively, all participations with values||participants|||Number
818172|NCT01125605|Secondary|Direction of Change of Symptom Nervousness/Restlessnes Between Baseline and Last Observation by Duration of Treatment|"The symptom nervousness/restlessness was analysed with respect to the direction of change between baseline (Visit 1) and the last documented visit (Visit 2 or Visit 3) by means of the categories improved, unchanged and worsened. For each symptom patients were included in the analysis only if the symptom had been present at Visit 1 (i.e. the baseline score value was > 0)."|begin (visit 1) and last observation (could be appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3))|exploratively, all participations with values||participants|||Number
818173|NCT01125605|Secondary|Direction of Change of Symptom Nervousness/Restlessnes Between Baseline and Last Observation by Concomitant Medication|The symptom nervousness/restlessnesswas analysed with respect to the direction of change between baseline (Visit 1) and the last documented visit (Visit 2 or Visit 3) by means of the categories “improved”, “unchanged” and “worsened”. For each symptom patients were included in the analysis only if the symptom had been present at Visit 1 (i.e. the baseline score value was > 0).|begin (visit 1) and last observation (could be appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3))|exploratively, all participations with values||participants|||Number
818174|NCT01125605|Secondary|Changes of the Sum Score Between Baseline and Last Observation by Concomitant Medication and Treatment Duration|"The severity of 12 symptoms (nervousness/restlessness, irritability/eccentricity, sleep disorders, fitful sleep, hyperactivity, nocturnal activity, lack of concentration/forgetfulness, tiredness, discontent, listlessness, gastrointestinal problems, and headache/pressure) was graded on a four-point scale from 0 (no complaints) to 3 (strong complaints) and for the sum score of all 12 individual symptom scores (0 (no complaints) - 36 (all strong complaints).
Decrease of the sumscore between baseline and last observation by concomitant medication (with and withour medication) and treatment duration (< 4 weeks and >= 4 weeks)"|begin (visit 1) and last obvservation (could be appr. after 2 weeks (visit 2) or 4 weeks (visit 3))|exploratively, all participations with values||units on a scale||Standard Deviation|Mean
818175|NCT01125605|Primary|Sumscore of 12 Individual Symptoms for Visit 1 (Baseline), Visit 2, and Visit 3|The severity of 12 symptoms (nervousness/restlessness, irritability/eccentricity, sleep disorders, fitful sleep, hyperactivity, nocturnal activity, lack of concentration/forgetfulness, tiredness, discontent, listlessness, gastrointestinal problems, and headache/pressure) was graded on a four-point scale from 0 (no complaints) to 3 (strong complaints) and for the sum score of all 12 individual symptom scores (0 (no complaints) - 36 (all strong complaints).|begin (visit 1), appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3)|descriptive; for all partcipations with values at the visits||units on a scale||Standard Deviation|Mean
818176|NCT01125722|Secondary|Change in Mean Overactive Bladder Symptom Composite Score|The Overactive Bladder Symptom Composite is a composite symptom score of toilet voids, urgency severity and urge urinary incontinence. It combines the Indevus Urgency Severity Scale for capture of urgency severity per toilet void with 24-hour frequency and urinary urge incontinence episodes. A complete reference for this validated measure can be found in teh Journal of Urology, Vol. 173, pgs 1639-1643, May 2005. The scale is specific to the instrument and lower scores represent an improvement in symptoms. The scale is a weighted average of each void a subject has. The weights are assigned as 0=no urgency, 1=mild, 2=moderate, 3=severe. The minimum score is 0, corresponding to no urgency in every void. There is no quantifiable upper limit since the scale is based on the number of voids per day, but there are reasonable upper limits. For example, if a subject had 15 voids in 1 day and all 15 were severe (=3), the Composite Score would be 45. Full details are in the reference above.|From Baseline to Week 4 of active treatment|Modified Intent-to-Treat Set (Full Analysis Set) - defined as all eligible subjects who were randomized to one of the two treatment arms and received some treatment.||scores on a scale||Standard Deviation|Mean
818177|NCT01125722|Secondary|Change in Mean Urgency Episodes Per Day|Mean urgency episodes per day is based on a 3-day diary maintained by the subject. An urgency episode is identified by the subject as a case where they have a strong urge to urinate, i.e. difficulty controlling the bladder and thus are rushing to the bathroom. The number of urgency episodes over 3 days was recorded for each subject at baseline and again at Week 4. The 3-day average at each time point was used as the mean over 24 hours and the change from baseline to Week 4 was calculated for each subject.|From Baseline to Week 4 of active treatment|Modified Intent-to-Treat Set (Full Analysis Set) - defined as all eligible subjects who were randomized to one of the two treatment arms and received some treatment.||number of urgency episodes per 24 hours||Standard Deviation|Mean
818178|NCT01125722|Secondary|Change in Mean Volume Per Void|Mean volume per void (or amount of urine per urination) over 24 hours is based on a 3-day diary maintained by the subject. The volume of void (in milliliters) over 3 days was recorded for each subject at baseline and again at Week 4. The 3-day average at each time point was used as the mean over 24 hours and the change from baseline to Week 4 was calculated for each subject.|From Baseline to Week 4 of active treatment|Modified Intent-to-Treat Set (Full Analysis Set) - defined as all eligible subjects who were randomized to one of the two treatment arms and received some treatment.||mL||Standard Deviation|Mean
818179|NCT01125722|Secondary|Change in Mean Daily Voiding Frequency|Mean daily voiding frequency over 24 hours is based on a 3-day diary maintained by the subject. Voiding frequency is defined as the number of times a subject urinates. The number of voids over 3 days was recorded for each subject at baseline and again at Week 4. The 3-day average at each time point was used as the mean over 24 hours and the change from baseline to Week 4 was calculated for each subject.|From baseline to Week 4 of active treatment|Modified Intent-to-Treat Set (Full Analysis Set) - defined as all eligible subjects who were randomized to one of the two treatment arms and received some treatment.||number of voids per 24 hours||Standard Deviation|Mean
818180|NCT01125722|Primary|Change in Mean Daily Urgency Incontinence Episodes|Mean urgency incontinence episodes (or urinary leaks) over 24 hours is based on a 3-day diary maintained by the subject. Urgency incontinence is when a subject has urinary leakage, i.e., uncontrolled release of fluid prior to making it to the bathroom. The number of leaks over 3 days was recorded for each subject at baseline and again at Week 4. The 3-day average at each time point was used as the mean over 24 hours and the change from baseline to Week 4 was calculated for each subject.|From baseline to Week 4 of active treatment|Modified Intent-to-Treat Set (Full Analysis Set) - defined as all eligible subjects who were randomized to one of the two treatment arms and received some treatment.||number of incontinence episodes/24 hours||Standard Deviation|Mean
818181|NCT01125748|Secondary|Time to the First Protocol-defined Severe Exacerbation|A protocol-defined severe exacerbation was a clinically significant worsening of asthma which, in the clinical judgment of the investigator, required at least 1 of the following: (1) Initiation of systemic corticosteroid treatment (tablets, suspension, or injection) or an increase in the level of systemic corticosteroid treatment from a stable maintenance dose for at least 3 days (For patients taking chronic oral corticosteroids, a protocol-defined severe exacerbation was any clinically significant worsening of asthma requiring ≥ 3 days of treatment with at least a 20 mg increase in the average daily dose of oral prednisone or a comparable dose of systemic corticosteroids) or (2) a hospitalization or emergency room visit because of asthma requiring systemic corticosteroids.|Baseline to the end of the study (up to 52 weeks)|Intent-to-treat population: All randomized participants.||Weeks||95% Confidence Interval|Mean
818182|NCT01125748|Primary|Percentage of Participants Not Experiencing a Protocol-defined Severe Exacerbation During the Study|A protocol-defined severe exacerbation was a clinically significant worsening of asthma which, in the clinical judgment of the investigator, required at least 1 of the following: (1) Initiation of systemic corticosteroid treatment (tablets, suspension, or injection) or an increase in the level of systemic corticosteroid treatment from a stable maintenance dose for at least 3 days (For patients taking chronic oral corticosteroids, a protocol-defined severe exacerbation was any clinically significant worsening of asthma requiring ≥ 3 days of treatment with at least a 20 mg increase in the average daily dose of oral prednisone or a comparable dose of systemic corticosteroids) or (2) a hospitalization or emergency room visit because of asthma requiring systemic corticosteroids.|Baseline to the end of the study (up to 52 weeks)|Intent-to-treat population: All randomized participants.||Percentage of participants||95% Confidence Interval|Number
818183|NCT01125774|Secondary|Mean Monthly On-drug Headache Days During the Entire Study Period Among Participants With PMM Who Have an Average of 3 or More Moderate or Severe Migraine Headaches Per Month at Baseline|Participants completed a headache diary each evening at bedtime, including recording headache duration and acute headache medication use. Mean monthly on-drug headache days was calculated from diary data. “On-drug” headache day was a day, which had a valid diary entry and which followed a study drug dosing day, in which a headache (defined as headache pain ≥30 minute duration or requiring acute treatment) started, ended, or recurred. Headache pain persisting for more than 1 calendar day after initial onset into additional qualifying days (i.e., day following dosing day) was considered an occurrence of additional headache days. Mean monthly rate was adjusted to 7 days. PMM participant subgroups (based on symptoms over the 3 menstrual cycles prior to study) – In ≥2 out of 3 cycles attacks occur exclusively on Day 1 ± 2 of menstruation and at no other times of the cycle.|Up to 6 months|All randomized participants who were randomized only once, took at least 1 dose of study drug, had ≥1 post-randomization efficacy measurement, met the definition of the PMM subgroup and reported average of ≥3 moderate-severe migraine headaches/month at baseline. Participant must have ≥1 month with ≥4 dosing days.||Days per month||Standard Error|Mean
818190|NCT01125774|Primary|Number of Participants Who Discontinued Study Due to a Clinical AE|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE. A clinical AE is an AE reported as a result of a clinical examination or reported by the participant.|Up to 6 months|APaT population, which included all randomized participants who took at least one dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm.||Participants|||Number
818184|NCT01125774|Secondary|Mean Monthly On-drug Headache Days During the Entire Study Period Among Participants With MRM Who Have an Average of 5 or More Moderate or Severe Migraine Headaches Per Month at Baseline|Participants completed a headache diary each evening at bedtime, including recording headache duration and acute headache medication use. Mean monthly on-drug headache days was calculated from diary data. “On-drug” headache day was a day, which had a valid diary entry and which followed a study drug dosing day, in which a headache (defined as headache pain ≥30 minute duration or requiring acute treatment) started, ended, or recurred. Headache pain persisting for more than 1 calendar day after initial onset into additional qualifying days (i.e., day following dosing day) was considered an occurrence of additional headache days. Mean monthly rate was adjusted to 7 days. MRM participant subgroup (based on symptoms over the 3 menstrual cycles prior to study) - In ≥2 out of 3 cycles attacks occur on Day 1 ± 2 of menstruation additionally at other times of the cycle.|Up to 6 months|All randomized participants who were randomized only once, took at least 1 dose of study drug, had ≥1 post-randomization efficacy measurement, met the definition of the MRM subgroup and reported average of ≥5 moderate-severe migraine headaches/month at baseline. Participant must have ≥1 month with ≥4 dosing days.||Days per month||Standard Error|Mean
818185|NCT01125774|Secondary|Mean Monthly On-drug Headache Days During the Entire Study Period Among Participants With MRM or PMM Who Have an Average of 5 or More Moderate or Severe Migraine Headaches Per Month at Baseline|Participants completed a headache diary each evening at bedtime, including recording headache duration and acute headache medication use. Mean monthly on-drug headache days was calculated from diary data. “On-drug” headache day was a day, which had a valid diary entry and which followed a study drug dosing day, in which a headache (defined as headache pain ≥30 minute duration or requiring acute treatment) started, ended, or recurred. Headache pain persisting for more than 1 calendar day after initial onset into additional qualifying days (i.e., day following dosing day) was considered an occurrence of additional headache days. Mean monthly rate was adjusted to 7 days. Participant subgroups (based on symptoms over the 3 menstrual cycles prior to study): PMM – In ≥2 out of 3 cycles attacks occur exclusively on Day 1 ± 2 of menstruation and at no other times of the cycle; MRM - In ≥2 out of 3 cycles attacks occur on Day 1 ± 2 of menstruation and additionally at other times of the cycle.|Up to 6 months|All randomized participants who were randomized only once, took at least 1 dose of study drug, had ≥1 post-randomization efficacy measurement, met the definition of the MRM or PMM subgroup and reported average of ≥5 moderate-severe migraine headaches/month at baseline. Participant must have ≥1 month with ≥4 dosing days.||Days per month||Standard Error|Mean
818186|NCT01125774|Secondary|Mean Monthly Headache Days During Entire Study Period Among Participants With MRM Who Have an Average of 5 or More Moderate or Severe Migraine Headaches Per Month at Baseline|Participants completed a headache diary each evening at bedtime, including recording headache duration and acute headache medication use. Mean monthly headache days was calculated from diary data. A headache day was defined as a day in which a headache (defined as headache pain ≥30 minute duration or requiring acute treatment) started, ended, or recurred. Headache pain persisting for more than 1 calendar day after initial onset was considered an occurrence of additional headache days. Mean monthly rate was adjusted to 28 days. MRM participant subgroup (based on symptoms over the 3 menstrual cycles prior to study) - In ≥2 out of 3 cycles attacks occur on Day 1 ± 2 of menstruation and additionally at other times of the cycle.|Up to 6 months|All randomized participants who were randomized only once, took at least 1 dose of study drug, had ≥1 post-randomization efficacy measurement, met the definition of the MRM subgroup and reported average of ≥5 moderate-severe migraine headaches/month at baseline. Participant must have ≥1 month with ≥4 dosing days and ≥7 diary days.||Days per month||Standard Error|Mean
818187|NCT01125774|Primary|Mean Monthly Headache Days During Entire Study Period Among Participants With Menstrually-related Migraine (MRM) or Pure Menstrual Migraine (PMM) Who Have an Average of 5 or More Moderate or Severe Migraine Headaches Per Month at Baseline|Participants completed a headache diary each evening at bedtime, including recording headache duration and acute headache medication use. Mean monthly headache days was calculated from diary data. A headache day was defined as a day in which a headache (defined as headache pain ≥30 minute duration or requiring acute treatment) started, ended, or recurred. Headache pain persisting for more than 1 calendar day after initial onset was considered an occurrence of additional headache days. Mean monthly rate was adjusted to 28 days. Participant subgroups (based on symptoms over the 3 menstrual cycles prior to study): PMM – In ≥2 out of 3 cycles attacks occur exclusively on Day 1 ± 2 of menstruation and at no other times of the cycle; MRM - In ≥2 out of 3 cycles attacks occur on Day 1 ± 2 of menstruation and additionally at other times of the cycle.|Up to 6 months|All randomized participants who were randomized only once, took at least 1 dose of study drug, had ≥1 post-randomization efficacy measurement, met the definition of the MRM or PMM subgroup and reported average of ≥5 moderate-severe migraine headaches/month at baseline. Participant must have ≥1 month with ≥4 dosing days and ≥7 diary days.||Days per month||Standard Error|Mean
818188|NCT01125774|Primary|Number of Participants Who Discontinued Study Due to a Laboratory AE|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE. A laboratory AE is an AE reported as a result of a laboratory assessment or test.|Up to 6 months|APaT population, which is all randomized participants who took at least one dose of study drug. Also to be included participant must have at least one post-baseline lab test. Participants were included in arm corresponding to the treatment actually taken. Participants who took both treatments were included in the telcagepant 140 mg treatment arm.||Participants|||Number
818189|NCT01125774|Primary|Number of Participants With Laboratory AEs|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE. A laboratory AE is an AE reported as a result of a laboratory assessment or test.|Up to 6 months|APaT population, which is all randomized participants who took at least one dose of study drug. Also to be included participant must have at least one post-baseline lab test. Participants were included in arm corresponding to the treatment actually taken. Participants who took both treatments were included in the telcagepant 140 mg treatment arm.||Participants|||Number
818191|NCT01125774|Primary|Number of Participants With Clinical Adverse Events (AEs)|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE. A clinical AE is an AE reported as a result of a clinical examination or reported by the participant.|Up to 14 days after the last dose of study drug (Up to 6.5 months)|All Participants as Treated (APaT) population, which included all randomized participants who took at least one dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm.||Participants|||Number
818196|NCT01112241|Primary|Absolute Change of Functional Residual Capacity (FRC) After Bronchodilators|Following albuterol plus tiotropium inhalation, FRC decrements ≥0.30 liters (L) as compared to baseline, in an individual subject, were considered as evidence of response to bronchodilators, according to O'Donnell et al. [Eur Respir J 2001; 18: 914-920]. They were calculated as follows: [FRC (L), before bronchodilators - FRC (L) after bronchodilators].|Baseline and 90 min after bronchodilators|Seventeen consecutive, clinically-stable, Caucasian outpatients, presenting with mild-to-very-severe obliterative bronchiolitis following hematopoietic stem cell transplantation (HSCT) for hematological malignancies, were studied. They were diagnosed from 460 patients (253 males, 207 females) undergoing HSCT (sourcing from bone marrow).||absolute negative change (liters)||Standard Deviation|Mean
818197|NCT01112241|Primary|Per Cent Change of Functional Residual Capacity (FRC) After Bronchodilators|Following albuterol plus tiotropium inhalation, FRC decrements ≥10 per cent as compared to baseline, in an individual subject, were considered as evidence of response to bronchodilators, according to O'Donnell et al. [Eur Respir J 2001; 18: 914-920]. They were calculated as follows: [FRC, expressed in liters (L), before bronchodilators - FRC (L) after bronchodilators/FRC (L) after bronchodilators x 100].|Baseline and 90 min after bronchodilators|Seventeen consecutive, clinically-stable, Caucasian outpatients, presenting with mild-to-very-severe obliterative bronchiolitis following hematopoietic stem cell transplantation (HSCT) for hematological malignancies, were studied. They were diagnosed from 460 patients (253 males, 207 females) undergoing HSCT (sourcing from bone marrow).||per cent negative change||Standard Deviation|Mean
818198|NCT01112241|Primary|Absolute Change of Residual Volume (RV) After Bronchodilators|Following albuterol plus tiotropium inhalation, RV decrements ≥0.30 liters (L) as compared to baseline, in an individual subject, were considered as evidence of response to bronchodilators, according to O'Donnell et al. [Eur Respir J 2001; 18: 914-920]. They were calculated as follows: [RV (L), before bronchodilators - RV (L) after bronchodilators].|Baseline and 90 min after bronchodilators|Seventeen consecutive, clinically-stable, Caucasian outpatients, presenting with mild-to-very-severe obliterative bronchiolitis following hematopoietic stem cell transplantation (HSCT) for hematological malignancies, were studied. They were diagnosed from 460 patients (253 males, 207 females) undergoing HSCT (sourcing from bone marrow).||absolute negative change (liters)||Standard Deviation|Mean
818199|NCT01112241|Primary|Per Cent Change of Residual Volume (RV) After Bronchodilators|Following albuterol plus tiotropium inhalation, RV decrements ≥10 per cent as compared to baseline, in an individual subject, were considered as evidence of response to bronchodilators, according to O'Donnell et al. [Eur Respir J 2001; 18: 914-920]. They were calculated as follows: [RV, expressed in liters (L), before bronchodilators - RV (L) after bronchodilators/RV (L) after bronchodilators x 100].|Baseline and 90 min after bronchodilators|Seventeen consecutive, clinically-stable, Caucasian outpatients, presenting with mild-to-very-severe obliterative bronchiolitis following hematopoietic stem cell transplantation (HSCT) for hematological malignancies, were studied. They were diagnosed from 460 patients (253 males, 207 females) undergoing HSCT (sourcing from bone marrow).||per cent negative change||Standard Deviation|Mean
818200|NCT01112241|Primary|Per Cent Change of Partial Forced Expiratory Flow (V'Part) After Bronchodilators|Following albuterol plus tiotropium inhalation, V'part increments ≥40 per cent as compared to baseline, in an individual subject, were considered as evidence of response to bronchodilators, according to Pellegrino et al. [Chest 1998; 114:1607-1612]. They were calculated as follows: [V'part, expressed in liters.second-1 (L.s-1), after bronchodilators - V'part (L.s-1) before bronchodilators/V'part (L.s-1) before bronchodilators x 100].|Baseline and 90 min after bronchodilators|Seventeen consecutive, clinically-stable, Caucasian outpatients, presenting with mild-to-very-severe obliterative bronchiolitis following hematopoietic stem cell transplantation (HSCT) for hematological malignancies, were studied. They were diagnosed from 460 patients (253 males, 207 females) undergoing HSCT (sourcing from bone marrow).||per cent positive change||Standard Deviation|Mean
818201|NCT01112241|Primary|Per Cent Change of Instantaneous Maximal Forced Expiratory Flow (V'Max) After Bronchodilators|Following albuterol plus tiotropium inhalation, V'max increments ≥40 per cent as compared to baseline, in an individual subject, were considered as evidence of response to bronchodilators, according to Pellegrino et al. [Chest 1998; 114:1607-1612]. They were calculated as follows: [V'max, expressed in liters.second-1 (L.s-1), after bronchodilators - V'max (L.s-1) before bronchodilators/V'max (L.s-1) before bronchodilators x 100].|Baseline and 90 min after bronchodilators|Seventeen consecutive, clinically-stable, Caucasian outpatients, presenting with mild-to-very-severe obliterative bronchiolitis following HSCT for hematological malignancies, were studied. They were diagnosed from 460 patients (253 males, 207 females) undergoing HSCT (sourcing from bone marrow).||per cent positive change||Standard Deviation|Mean
818202|NCT01112241|Primary|Absolute Change of Forced Vital Capacity (FVC) After Bronchodilators|Following albuterol plus tiotropium inhalation, FVC increments ≥0.20 liters (L) compared with baseline, in an individual subject, were considered as evidence of response to bronchodilators, according to the American Thoracic Society-European Respiratory Society standard criteria [Pellegrino et al. Eur Respir J 2005; 26: 948-968]. They were calculated as follows: [FVC (L) after bronchodilators - FVC (L) before bronchodilators].|Baseline and 90 min after bronchodilators|Seventeen consecutive, clinically-stable, Caucasian outpatients, presenting with mild-to-very-severe obliterative bronchiolitis following hematopoietic stem cell transplantation (HSCT) for hematological malignancies, were studied. They were diagnosed from 460 patients (253 males, 207 females) undergoing HSCT (sourcing from bone marrow).||absolute positive change (liters)||Standard Deviation|Mean
818203|NCT01112241|Primary|Per Cent Change of Forced Vital Capacity (FVC) After Bronchodilators|Following albuterol plus tiotropium inhalation, FVC increments ≥12 per cent as compared to baseline, in an individual subject, were considered as evidence of response to bronchodilators, according to the American Thoracic Society-European Respiratory Society standard criteria [Pellegrino et al. Eur Respir J 2005; 26: 948-968]. They were calculated as follows: [FVC, expressed in liters (L), after bronchodilators - FVC (L) before bronchodilators/FVC (L) before bronchodilators x 100].|Baseline and 90 min after bronchodilators|Seventeen consecutive, clinically-stable, Caucasian outpatients, presenting with mild-to-very-severe obliterative bronchiolitis following hematopoietic stem cell transplantation (HSCT) for hematological malignancies, were studied. They were diagnosed from 460 patients (253 males, 207 females) undergoing HSCT (sourcing from bone marrow).||per cent positive change||Standard Deviation|Mean
818204|NCT01112241|Primary|Absolute Change of Forced Expiratory Volume in 1 Second (FEV1) After Bronchodilators|Following albuterol plus tiotropium inhalation, FEV1 increments ≥0.20 liters (L) as compared to baseline, in an individual subject, were considered as evidence of response to bronchodilators, according to the American Thoracic Society-European Respiratory Society standard criteria [Pellegrino et al. Eur Respir J 2005; 26: 948-968]. They were calculated as follows: [FEV1 (L) after bronchodilators - FEV1 (L) before bronchodilators].|Baseline and 90 min after bronchodilators|Seventeen consecutive, clinically-stable, Caucasian outpatients, presenting with mild-to-very-severe obliterative bronchiolitis following hematopoietic stem cell transplantation (HSCT) for hematological malignancies, were studied. They were diagnosed from 460 patients (253 males, 207 females) undergoing HSCT (sourcing from bone marrow).||absolute positive change (liters)||Standard Deviation|Mean
818205|NCT01112241|Primary|Per Cent Change of Forced Expiratory Volume in 1 Second (FEV1) After Bronchodilators|Following albuterol plus tiotropium inhalation, FEV1 increments ≥12 per cent as compared to baseline, in an individual subject, were considered as evidence of response to bronchodilators, according to the American Thoracic Society-European Respiratory Society standard criteria [Pellegrino et al. Eur Respir J 2005; 26: 948-968]. They were calculated as follows: [FEV1, expressed in liters (L), after bronchodilators - FEV1 (L) before bronchodilators/FEV1 (L) before bronchodilators x 100].|Baseline and 90 min after bronchodilators|Seventeen consecutive, clinically-stable, Caucasian outpatients, presenting with mild-to-very-severe obliterative bronchiolitis following hematopoietic stem cell transplantation (HSCT) for hematological malignancies, were studied. They were diagnosed from 460 patients (253 males, 207 females) undergoing HSCT (sourcing from bone marrow).||per cent positive change||Standard Deviation|Mean
818206|NCT01112267|Secondary|Percentage of Participants With Participants' Global Assessment on Investigational Product|"Global assessment on investigational product was done by participants on how well the investigational product controlled chronic (lasting a long time) low back pain. Assessment was done by categories 'Very bad (-2)' 'Bad (-1)' 'Not changed (0) 'Good (1)' and 'Very good (2)'. Assessment better than Good was considered as pain improvement success. Percentage of participants with pain improvement success is reported here."|Day 29|The FAS population included all the participants who had received investigational product and had at least 1 data of measurement of primary efficacy endpoint. Here ‘N’ signifies those participants who were evaluated for this outcome measure.||Percentage of participants||95% Confidence Interval|Number
818207|NCT01112267|Secondary|Percentage of Participants With Investigator's Global Assessment on Investigational Product|"Global assessment on investigational product was done by investigator on how well the investigational product controlled chronic (lasting a long time) low back pain. Assessment was done by categories 'Very bad (-2)' 'Bad (-1)' 'Not changed (0) 'Good (1)' and 'Very good (2)'. Assessment better than Good was considered as pain improvement success. Percentage of participants with pain improvement success is reported here."|Day 29|The FAS population included all the participants who had received investigational product and had at least 1 data of measurement of primary efficacy endpoint. Here ‘N’ signifies those participants who were evaluated for this outcome measure.||Percentage of participants||95% Confidence Interval|Number
818208|NCT01112267|Secondary|Change From Baseline in Oswestry Disability Index (ODI) Korean Version Score at Day 29|The ODI Korean version was used to assess the participant's functionality. The ODI is a low back pain-specific, validated instrument that consists of questions related to limitations in performing specific activities of daily living and 1 question related to pain intensity. The ODI is a self-administered questionnaire consists of 10 sections. Each section consists of 6 statements ranked from 0 to 5 (0=good to 5=worse). Total score is the sum of score obtained in each section and ranges from 0 to 50. A higher score represents greater disability.|Baseline and Day 29|FAS population included all participants who had received investigational product and had at least 1 data of measurement of primary efficacy endpoint.||Unit on a scale||Standard Deviation|Mean
818209|NCT01112267|Secondary|Change From Baseline in Short Form (SF)-36 Score at Day 29|"The quality of life of participants was evaluated by SF-36 Korean version questionnaire. It is composed of 8 domains: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. Participants answered to the questionnaire of 36 questions; and physical, social, and psychological health status were assessed. It ranges 0 to 100, and higher score indicates better quality of life, But in Reported (Rptd.) Health Transition domain higher score indicates worse quality of life."|Baseline and Day 29|The FAS population included all the participants who had received investigational product and had at least 1 data of measurement of primary efficacy endpoint.||Unit on a scale||Standard Deviation|Mean
818394|NCT01125930|Secondary|Severity of Erythematotelangiectatic Signs: Dryness/Irritation|Severity of erythematotelangiectatic signs include redness (non-transient erythema), telangiectasia, facial edema, and dry skin.|2, 6, 12, 18 weeks|LOCF, Complete-Case ITT Population||participants|||Number
818210|NCT01112267|Secondary|Percentage of Participants With Pain Relief|Pain relief was measured in 6 stages to assess the participant's pain relief. Extent of pain relief was measured on a scale ranging from 4 to -1, where 4=complete disappearance, 3=fair relief, 2=moderate relief, 1=slight relief, 0=no change and -1=pain worsening. Relief more than 'slight relief (1)' was considered as pain relief success.|Day 8, Day 15 and Day 29|the FAS population included all the participants who had received investigational product and had at least 1 data of measurement of primary efficacy endpoint.||Percentage of participants||95% Confidence Interval|Number
818211|NCT01112267|Primary|Change From Baseline in Pain Intensity at Day 29|Change in pain intensity experienced by participants over the last 48 hours was measured on Day 29 against Baseline with VAS. VAS is a 10 cm scale. Intensity of pain range: 0 cm=no pain to 10 cm=worst possible pain.|Baseline and Day 29|The FAS population included all the participants who had received investigational product and had at least 1 data of measurement of primary efficacy endpoint.||Unit on a scale||Standard Deviation|Mean
818212|NCT01112267|Primary|Percentage of Participants With Reduction in Pain Intensity|The percentage of participants with extent of reduction in pain intensity greater than or equal to 30 percent was reported. Pain intensity change rate was calculated by Visual Analog Scale (VAS) score at baseline minus VAS score at Day 29 divided by VAS score at Baseline. VAS is a 10 centimeter (cm) scale. Intensity of pain range: 0 cm=no pain to 10 cm=worst possible pain.|Baseline up to Day 29|Full analysis set (FAS) population included all participants who had received investigational product and had at least 1 data of measurement of primary efficacy endpoint.||Percentage of Participants||95% Confidence Interval|Number
818213|NCT01117857|Other Pre-specified|Change in Overall Well Being Measured by the Clinical Global Impression Scale (CGI)|The CGI is a scale to measure the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Severity is ranked 1, normal, not at all ill; 2, borderline ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. A higher score indicates greater symptom severity.|Baseline to week 9|Of the 19 participants who received study medication, 16 were considered evaluable for the purpose of analyses as they returned for at least one assessment after starting the study intervention.||units on a scale||Inter-Quartile Range|Median
818214|NCT01117857|Other Pre-specified|Change in Hot Flash Interference With Daily Activities and Quality of Life as Measured by the Hot Flash Related Daily Interference Scale (HFRDIS)|The HFRDIS is a 10-item self-report questionnaire in which subjects rate the degree to which hot flashes interfere with daily activities and quality-of-life during the prior week. Each item is rated on a scale from 0 (does not interfere) to 10 (completely interferes) for a total score range of 0-100 (higher score indicates greater symptom burden/interference).|Baseline to week 9|Of the 19 participants who received study medication, 16 were considered evaluable for the purpose of analyses as they returned for at least one assessment after starting the study intervention.||units on a scale||Inter-Quartile Range|Median
818215|NCT01117857|Other Pre-specified|Change in Anxiety as Measured by the Generalized Anxiety Disorder Questionnaire (GAD-7)|The GAD-7 is a valid and efficient tool for screening anxiety and assessing its severity in clinical practice and research. Subjects rate the items for severity on a 4-point scale from 0 (not at all) to 3 (nearly every day) for a total range of 0-21. A higher score indicates greater anxiety symptom burden.|Baseline to week 9|Of the 19 participants who received study medication, 16 were considered evaluable for the purpose of analyses as they returned for at least one assessment after starting the study intervention.||units on a scale||Inter-Quartile Range|Median
818216|NCT01117857|Secondary|Change in Menopause Symptoms as Measured by the Greene Climacteric Scale|The Greene Climacteric Scale (GCS) is a 21-item scale used to quantify the severity of perimenopausal somatic symptoms. Each item is scored 0-3 for a total range of 0-63, with a higher score indicating greater symptom severity.|Baseline to week 9|Of the 19 participants who received study medication, 16 were considered evaluable for the purpose of analyses as they returned for at least one assessment after starting the study intervention.||units on a scale||Inter-Quartile Range|Median
818217|NCT01117857|Primary|Change in Depression Scores as Measured by the Hamilton Rating Scale for Depression|The HAM-D is a 17-item well-validated and reliable measure of current depressive symptoms and their severity. Eight items are scored on a five-point scale (0-4), and nine are scored on a three-point scale (0-2) for a total score range of 0-50. A higher score indicates greater symptom severity.|Baseline to week 9|Of the 19 participants who received study medication, 16 were considered evaluable for the purpose of analyses as they returned for at least one assessment after starting the study intervention.||units on a scale||Inter-Quartile Range|Median
818218|NCT01117870|Secondary|Number of Participants Who Discontinued Analgesics After Intervention|Number of PRF treatment patients with increase or decrease in medication use (either in dose, frequency, or no use), compared with the placebo group.|4 weeks|Number of participants who discontinued analgesics after intervention||Participants|||Count of Participants
818219|NCT01117870|Secondary|Change in Oswestry Disability Index (ODI) From Baseline to 4 Week|ODI is an index derived from the Oswestry Low Back Pain Questionnaire used to quantify disability for low back pain. The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to: care for oneself, walk, sit, sexual function, stand, social life, sleep quality, and ability to travel. Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability.The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.|baseline (at recruitment) and at 4 weeks|Success defined as at least 50% improvement in Oswestry Disability Index (ODI) - measured at 4 weeks compared to placebo group.||percentage change of ODI||Standard Deviation|Mean
818236|NCT01118091|Primary|Response Rate|Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete response (CR) is the disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.|3 years|||Participants|||Number
818220|NCT01117870|Secondary|Assessment of Side Effects|Percentage of patients having side effects after PRF treatment assessed at 1 week compared to placebo group. Assessment of persisting side effects, percentage of patients having side effects after PRF treatment beyond 1 week compared to the placebo group. Side effects could be nausea, headache, momentary increase in pain, fever, tingling, itching, and/or burning skin at point of treatment|1 week and up to 3 months|Assessment of persisting side effects and percentage of patients having side effects after PRF treatment beyond 1 week compared to the placebo group. Side effects could be nausea, headache, momentary increase in pain, fever, tingling, itching, and/or burning skin at point of treatment||percentage of participants|||Number
818221|NCT01117870|Secondary|Change in Mean Visual Analogue Scale (VAS) Scores From Baseline to 4 Weeks|"Secondary outcomes were considered as exploratory. Is PRF an effective treatment for patients with CLR pain? It will be measured by a change in VAS scores from baseline measurement at recruitment.
Visual analog scale (VAS) - For pain intensity, the scale is most commonly anchored by “no pain” (score of 0) and “pain as bad as it could be” or “worst imaginable pain” (score of 10) on a 10-cm scale."|baseline (at recruitment) and at 4 Weeks|Intent to treat analysis was used.||units on a scale||Standard Deviation|Mean
818222|NCT01117870|Primary|Number of Participants Lost to Follow-up at 3 Months|Patients who were lost to follow-up at 3 months were recorded.|3 months|||Participants|||Count of Participants
818223|NCT01117870|Primary|Recruitment Rate|Expected recruitment is at least 4 patients per month. At least 80% of eligible patients fulfilling the selection criteria can be recruited. The final assessment was at the end of 15 months, at which time all the subjects were enrolled. Participants withdrawing within 4 weeks after the interventional shall not be included in the study. However participants withdrawing after 4 weeks of the intervention shall be included in the final analysis, on intention to treat principle.|15 month point|Patients with suspected leg pain were initially approached by the research assistant. Further screening for eligibility was done in the presence of the physician. Suitable patients met with the research assistant (blind to intervention), who noted down the baseline parameters of the patient after obtaining an informed consent.||Participants|||Count of Participants
818224|NCT01117948|Secondary|Activities of Daily Living - ADCS-ADL; Behavioral/Psychiatric Symptoms - NPI||6 months double-blind, 6 months open label (optional)||||||
818225|NCT01117948|Primary|Cognitive Performance - ADAS-cog+|"Alzheimer's disease Assessment Scale, Cognitive Subscale (15 item) Higher scores indicate cognitive impairment. All items are assessed by independent rater (psychologists). The score goes from 0 points (no cognitive impairment) to 95 points (maximum impairment in all 15 items).
Primary Outcome Measure is the change from baseline ADAS-cog+ score to the score after 26 weeks (end of double blind)."|6 months double blind, 6 months open-label (optional)|||units on a scale||Standard Deviation|Mean
818226|NCT01117987|Secondary|Percentage of Participants With Incidence of Clinical Worsening Events|Clinical worsening events included death, overnight hospitalization for worsening of PAH, worsening of World Health Organization (WHO) functional class by at least one level (drop in WHO ), 15% decrease in the 6MWD as compared to baseline confirmed by two 6MWTs at two consecutive study visits (6MWD reduction), and drop in WHO & 6MWD reduction. Some participants have fulfilled more than one criterion. Therefore, the sum of individual components may be higher than the total number of participants with clinical worsening.|204 weeks|Full Analysis Set (FAS): The full analysis set included all participants who received at least one dose of study drug during the extension.||Percentage of participants|||Number
818227|NCT01117987|Secondary|Change From Core Study Baseline in Six-Minute Walk Distance (6MWD)|A six minute walk test (6MWT) was performed in accordance with the guidleines of the American Thoracic Society (2002).|core study baseline, extension baseline, 12 weeks, 24 weeks, 48 weeks, 72 weeks, 96 weeks, 120 weeks, 144 weeks, 156 weeks, 204 weeks|Participants from the Full Analysis Set (FAS), who had values at both core study baseline and the given post-baseline time point, were included in the analysis for that post-baseline time point. The FAS included all participants who received at least one dose of study drug during the extension.||meters||Standard Deviation|Mean
818228|NCT01117987|Primary|Number of Participants With Adverse Events, Serious Adverse Events and Deaths|Adverse event monitoring was conducted throughout the study.|204 weeks|Safety analysis set: The safety set included all paticipants who received at least one dose of study drug during the extension.||Participants|||Number
818229|NCT01118013|Secondary|Rate of Opportunistic Infections|Percent of participants who have an opportunistic (viral, bacterial and fungal) infection in the first year following transplant.|1 year post transplant|Due to study termination, data were not collected and the outcome measure was not analyzed.|||||
818230|NCT01118013|Secondary|Overall Survival|Overall survival (OS) was defined as the transplant from registration to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% confidence interval (CI) was estimated using the Kaplan Meier method.|Up to 5.5 years|Due to study termination, data were not collected and the outcome measure was not analyzed.|||||
818231|NCT01118013|Secondary|Complete Response Rate|Complete response (CR) rate is reported as the percentage of participants who achieved a CR.|Up to 5.5 years|Due to study termination, data were not collected and the outcome measure was not analyzed.|||||
818232|NCT01118013|Primary|Comparison of EFS Distribution to That of CALGB-100002|EFS distributions between CALGB-100002 and this study will be compared using the two-sample log-rank test.|2 years|Due to study termination, data were not collected and the outcome measure was not analyzed.|||||
818233|NCT01118013|Primary|Event-free Survival (EFS)|EFS was defined as the date of transplant to date of progression or develop myelodysplasia after autologous transplant. EFS was estimated using the Kaplan Meier method.|Duration of study (up to 5.5 years)|Due to study termination, data were not collected and the outcome measure was not analyzed.|||||
818234|NCT01118091|Primary|Progression Free Survival|Measured from the time of randomization to time of progression (or death).|3 years|||Days|||Number
818235|NCT01118091|Secondary|Toxicity|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|3 years|||Participants|||Number
818237|NCT01118117|Secondary|Stent Fracture at 12 Months|Occurrence of stent fracture as determined by core laboratory analysis|12 Months post-procedure|X-rays for 324 stents (234 subjects) were available for analysis by the angiographic core laboratory to evaluate stent fractures at 12 months post-procedure. One stent fracture was caused by a physician during a non-study peripheral intervention.||percentage of fracture occurrence|Participants||Number
818243|NCT01118117|Secondary|Occurrence of Target Lesion Revascularization|"The occurrence of clinically driven Target Lesion Revascularization (TLR) was measured at 12 months post-procedure.
Clinically driven defined as:
More than 50 percent stenosis with worsening symptoms, OR
More than 70 percent stenosis without symptoms"|12 Months post-procedure|Comprised of all subjects enrolled in the pivotal OSPREY trial (N=261)||percentage of subjects with TLR|||Number
818244|NCT01118117|Secondary|Primary Effectiveness Endpoint Using a Peak Systolic Velocity Ratio of ≤ 2.4 (i.e., Modified VIVA Criteria) in the mITT Cohort|The primary effectiveness endpoint was defined as absence of TLR and stent patency at 12 months as evidenced by a peak systolic velocity ratio < 2.0 from duplex ultrasound. Additional considerations were made using a more contemporary approach to evaluate stent patency using a peak systolic velocity ratio (PSVR) ≤ 2.4 (i.e., modified VIVA criteria). This outcome evaluated the modified intent-to-treat (mITT) cohort comprised of 226 subjects (excluded subjects with unknown primary effectiveness endpoint)|12 Months post-procedure|Analysis uses a more contemporary approach to evaluate primary stent patency using a peak systolic velocity ratio ≤ 2.4 (modified VIVA criteria). Because patency beyond the 12 months visit window may be considered as patency at 12 months, the out-of-window patency is imputed as treatment success in the analysis.||percentage of stent patency|||Number
818245|NCT01118117|Primary|Primary Safety Endpoint|The primary safety endpoint for this study was freedom from major adverse events (MAE) at 30 days post-procedure. MAE was defined as TLR, amputation of the treated limb, or death.|30 days post-procedure|Study success was based on the proportion of patients with freedom from MAE at 30 days post-procedure when tested against a performance goal of 88% using the lower bound of the 95% confidence interval. In both cohorts, the lower confidence interval exceeded the prespecified performance goal indicating the study met its primary safety endpoint.||percentage of subjects without a MAE||95% Confidence Interval|Number
818246|NCT01118117|Secondary|Primary Effectiveness Endpoint in Modified Intent-to-Treat (mITT) Cohort|Primary effectiveness endpoint was defined as absence of TLR and stent patency at 12 months as evidenced by a peak systolic velocity ratio < 2.0 from DUS obtained within the 12 months visit window. Because patency beyond the 12 months visit window may be considered as patency at 12 months, the out-of-window patency is imputed as treatment success. The modified intention to treat (mITT) cohort had 226 subjects (excluded subjects with unknown primary effectiveness endpoint).|12 Months post-procedure|The modified intention to treat (mITT) cohort had 226 subjects (excluded subjects with unknown primary effectiveness endpoint).||percentage of stent patency|||Number
818247|NCT01118117|Primary|Primary Effectiveness Endpoint|The primary effectiveness endpoint was defined as stent patency at 12 months as evidenced by absence of TLR and a peak systolic velocity ratio < 2.0 from DUS obtained within the 12 months visit window.|12 Months post-procedure|Analysis comprised of 261 subjects enrolled in pivotal trial and missing data imputed as loss of patency under the intention-to-treat (ITT) analysis. Study success was based on the proportion of patients with stent patency when tested against a performance goal of 66% using the lower bound of the 95% confidence interval.||percentage of stent patency||95% Confidence Interval|Number
818248|NCT01118143|Secondary|Plaque Index|"The plaque index of the individual was obtained by adding the values of each tooth (an average of 4 scores) and dividing by number of teeth examined with the resulting scores as follows 0.1-1.0 = low accumulation of plaque; 1.1-2.0 = Moderate accumulation of plaque; 2.1-3.0 = high accumulation of plaque.
The Plaque index reference is Silness and Löe, 1964."|6 months after intervention|||units on a scale||Standard Deviation|Mean
818249|NCT01118143|Primary|Gingival Index|The gingival index of the individual was obtained by adding the values of each tooth (an average of 4 scores) and dividing by number of teeth examined with the resulting scores as follows 0.1-1.0 = mild inflammation; 1.1-2.0 = moderate inflammation; 2.1-3.0 = severe inflammation. The GI reference is Löe and Silness, 1963.|6 months after intervention|||units on a scale||Standard Deviation|Mean
818250|NCT01118221|Secondary|Maximum Oxygen Uptake|Change in 6 peak O2 uptake from Baseline to 3 Months|Maximum O2 uptake will be measured at 0 and 3 months.|||mL/minute||Standard Error|Mean
818251|NCT01118221|Secondary|Systemic Markers of Oxidant Stress|Plasma F2-isoprostanes measured in all subjects before and after exercise testing at baseline.|Markers of oxidant stress will be measured in all subjects before randomization after exercise testing at 0 months.|||pg/mL||Standard Deviation|Mean
818252|NCT01118221|Primary|6 Minute Walk Distance|Change in 6 Minute Walk Distance from Baseline to 3 Months|The 6-MWD will be measured at 0 and 3 months.|||meters||Standard Deviation|Mean
818253|NCT01118273|Secondary|Wake Episode Measured by Actigraphy|Actigraphy is a non-intrusive tool that measures an individual’s movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects. Wake Episodes - # of blocks of continuous wake epochs (defined as 2 or more consecutive epochs scored as wake that ends when there is at least one epoch scored as sleep subsequent to the start of the wake epochs).|Up to 10 hours|||Wake episodes||95% Confidence Interval|Least Squares Mean
818254|NCT01118273|Secondary|Activity Mean Measured by Actigraphy|Actigraphy is a non-intrusive tool that measures an individual’s movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects. Activity mean - average movement per minute.|Up to 10 hours|ITT (Intent to Treat) Population||Movement per minute||95% Confidence Interval|Least Squares Mean
818255|NCT01118273|Secondary|Sleep Efficiency Measured by Actigraphy|Sleep efficiency was calculated as (total sleep time/total time in-bed time) × 100; total in-bed time was fixed at 10 hours. Actigraphy is a non-intrusive tool that measures an individual’s movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.|Up to 10 hours|ITT (Intent to Treat) Population||Percentage of sleep time||95% Confidence Interval|Least Squares Mean
818256|NCT01118273|Secondary|Total Wake Time Measured by Actigraphy|Actigraphy is a non-intrusive tool that measures an individual’s movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.|Up to 10 hours|ITT (Intent to Treat) Population||Minutes||95% Confidence Interval|Least Squares Mean
818257|NCT01118273|Secondary|Number of Times Participants Took Rescue Medication|"Subjects were allowed to rescue and take a non-study pain reliever if the pain was not tolerable. This measure represents for the number of times rescue medication was taken by a subject."|Up to 10 hours|ITT (Intent to Treat) Population||Participants|||Number
838351|NCT01315158|Secondary|Predictors of Sedation Related Complications as Measured by the Number of Participants Who Experience Hypoxemia (Defined as a Pulse Oximetry <90% for Any Duration)||One year|||participants|||Number
818262|NCT01118273|Secondary|Change From Baseline in Visual Analog Scale (VAS) Score|Subjects completed the VAS scale at baseline (post-dental surgery) and after completion of the sleep period. Subjects marked a line on a 100-mm scale to indicate the severity of pain they are experiencing from 0 being no pain to 100 being worse possible pain.This measure indicates the change in pain severity rating on the VAS scale from baseline.|Baseline and up to 10 hours|ITT (Intent to Treat) Population||Scores on a scale||95% Confidence Interval|Least Squares Mean
818263|NCT01118273|Secondary|Overall Rating of Severity in Visual Analog Scale (VAS) Score|Subjects marked a line on a 100-mm scale to indicate the severity of pain they are experiencing from 0 being no pain to 100 being worse possible pain.|At 10 hours|ITT (Intent to Treat) Population||Scores on a scale||Standard Deviation|Mean
818264|NCT01118273|Secondary|Change From Baseline in Categorical Pain Rating Scale Score|Subjects responded to question, 'My pain at this time is' with following choices: no pain (0), mild pain (1), moderate pain (2), or severe pain (3). Subjects completed this question at baseline (post-dental surgery) and after sleep period. The following measure is the change in pain rating from baseline.|Baseline and up to 10 hours|ITT (Intent to Treat) Population||Scores on a scale||95% Confidence Interval|Least Squares Mean
818265|NCT01118273|Secondary|Overall Rating of Severity in Categorical Pain Rating Scale Score|Subject responded to question, 'My pain at this time is' by selecting one of the following choices: no pain (0), mild pain (1), moderate pain (2), or severe pain (3).|Up to 10 hours|ITT (Intent to Treat) Population||Scores on a scale||Standard Deviation|Mean
818266|NCT01118273|Secondary|Sleep Quality Index|Sleep Quality Index is the mean score of items, 'sleep quality', 'calm sleep', 'ease falling asleep', and 'slept throughout' on the Karolinska Sleep Diary, ranges from 1 (worst possible) to 5 (best possible).|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed).||Scores on a scale||95% Confidence Interval|Least Squares Mean
818267|NCT01118273|Secondary|Total Sleep Time by Subject Assessment|Subject responded to: Please estimate the number of hours and minutes you think that you slept.|Up to 10 hours|ITT (Intent to Treat) Population||Minutes||95% Confidence Interval|Least Squares Mean
818268|NCT01118273|Secondary|Karolinska Sleep Diary - Sufficient Sleep|Subject rating of following question with 1 being no, definitely too little to 5 being yes, definitely enough: Did you get enough (sufficient) sleep?|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)||Participants|||Number
818269|NCT01118273|Secondary|Karolinska Sleep Diary - Well Rested|Subject rating of following question with 1 being not rested at all to 3 being completely rested: Well-rested?|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)||Participants|||Number
818270|NCT01118273|Secondary|Karolinska Sleep Diary - Ease of Awakening|Subject rating of following question with 1 being very difficult to 5 being very easy: Ease of awakening?|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)||Participants|||Number
818271|NCT01118273|Secondary|Karolinska Sleep Diary - Premature Awakening|Subject rating of following question with 1 being woke up much too early to 3 being no: Premature awakening?|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)||Participants|||Number
818272|NCT01118273|Secondary|Karolinska Sleep Diary - Easiness to Fall Asleep|Subject rating of following question with 1 being very difficult to 5 being very easy: How easy was it to fall asleep?|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)||Participants|||Number
818273|NCT01118273|Secondary|Karolinska Sleep Diary - Calmness of Sleep|Subject rating of following question with 1 being very restless and 5 being very calm: How calm was your sleep?|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)||Participants|||Number
818274|NCT01118273|Secondary|Karolinska Sleep Diary - Sleep Quality|Subject rating of following question with 1 being very poor and 5 being very good: How was your sleep?|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)||Participants|||Number
818275|NCT01118273|Secondary|Global Assessment of Study Medication as a Sleep-aid|Subject rating of following question with 0 being poor to 4 being excellent: How would you rate the study medication you received as a sleep aid?|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)||Participants|||Number
818276|NCT01118273|Secondary|Sleep Latency Measured by Actigraphy|Actigraphy is a non-intrusive tool that measures an individual’s movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects. Sleep latency was defined as minutes to sleep onset since dosing, where sleep onset was the first 20-minute block with 19 minutes of sleep. For subjects who had not achieved sleep onset (e.g., due to taking rescue medication before achieving sleep onset), sleep latency was considered as censored at the time of wakening.|Up to 10 hours|ITT (Intent to Treat) Population||Minutes||95% Confidence Interval|Least Squares Mean
818277|NCT01118273|Secondary|Wake After Sleep Onset (WASO) Measured by Actigraphy|Actigraphy is a non-intrusive tool that measures an individual’s movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects. WASO was defined as minutes of awake during the period of sleep onset and offset, where sleep onset is the first 20-minute block with 19 minutes of sleep.|Up to 10 hours|ITT (Intent to Treat) Population||Minutes||95% Confidence Interval|Least Squares Mean
818278|NCT01118273|Primary|Total Sleep Time Measured by Actigraphy|Actigraphy is a non-intrusive tool that measures an individual’s movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects. In calculating the total sleep time, subjects who took rescue medication were treated as “awake” from the time the rescue medication was given until the end of the sleep period. In addition, if subjects rescued before sleep onset, their total sleep time was set to zero.|Up to 10 hours|ITT (Intent to Treat) Population||Minutes||95% Confidence Interval|Least Squares Mean
818279|NCT01118312|Secondary|Childhood Asthma Control Test|Childhood Asthma Control Test (score range: 0-27); higher score indicates better asthma control|24 weeks|Analysis of Children (less than 18 years old) Childhood Asthma Control Test scores||units on a scale||Standard Error|Mean
818280|NCT01118312|Primary|Asthma Control Test (ACT)|Asthma Control Test for adults (score range: 5-25); higher score indicates better asthma control|24 weeks|Analysis of adult (18 and above) Asthma Control Scores||units on a scale||Standard Error|Mean
818281|NCT01118325|Secondary|AR-C124910XX (Tmax) at Week 4|Time to reach peak or maximum concentration of AZD6140 drug metabolite AR-C124910XX following AZD6140 administration|Week 4|In total 7 Japanese patients (4 patients in 45 mg and 3 patients in 90 mg) were excluded from the PK analysis set since PK samples of these patients were discarded due to a database set-up issue at the central laboratory.||hour||Full Range|Median
818282|NCT01118325|Secondary|AR-C124910XX (AUC0-tau) at Week 4|Area under the plasma concentration curve of AZD6140 drug metabolite AR-C124910XX from time zero to dosing interval|Week 4|In total 7 Japanese patients (4 patients in 45 mg and 3 patients in 90 mg) were excluded from the PK analysis set since PK samples of these patients were discarded due to a database set-up issue at the central laboratory.||ng.h/mL||Standard Deviation|Geometric Mean
818283|NCT01118325|Secondary|AR-C124910XX (Cmax) at Week 4|Maximum plasma concentration of AZD6140 drug metabolite AR-C124910XX|Week 4|In total 7 Japanese patients (4 patients in 45 mg and 3 patients in 90 mg) were excluded from the PK analysis set since PK samples of these patients were discarded due to a database set-up issue at the central laboratory.||ng/mL||Standard Deviation|Geometric Mean
818284|NCT01118325|Secondary|AZD6140 (Tmax) at Week 4|Time to reach peak or maximum concentration of AZD6140 following AZD6140 administration|Week 4|In total 7 Japanese patients (4 patients in 45 mg and 3 patients in 90 mg) were excluded from the PK analysis set since PK samples of these patients were discarded due to a database set-up issue at the central laboratory.||hour||Full Range|Median
818285|NCT01118325|Secondary|AZD6140 (AUC0-tau) at Week 4|Area under the plasma concentration curve of AZD6140 from time zero to dosing interval|Week 4|In total 7 Japanese patients (4 patients in 45 mg and 3 patients in 90 mg) were excluded from the PK analysis set since PK samples of these patients were discarded due to a database set-up issue at the central laboratory.||ng.h/mL||Standard Deviation|Geometric Mean
818286|NCT01118325|Secondary|AZD6140 (Cmax) at Week 4|Maximum plasma AZD6140 concentration|Week 4|Only Japanese participants who had IPA data at Week 4 were considered in this analysis||ng/mL||Standard Deviation|Geometric Mean
818287|NCT01118325|Primary|IPA Final Extent at 24 Hours Post Dose on Week 4 in Japanese Patients|"Final extent IPA from pre-dose baseline was calculated using the following formula for ADP-induced platelet aggregation:
Percentage Inhibition = 100% x (PAs - PA) / (PAs) PA was the mean response at the given post dose time point and PAs was the mean response at pre dose baseline. Percentage inhibition was restricted to the closed interval [0,100]; any data falling outside this range was truncated to the appropriate limit."|Week 4|Only Japanese participants who had IPA data at Week 4 were considered in this analysis. Arm AZD6140 90 mg bd includes one non-Japanese participant resident in Japan||percentage inhibition||Standard Deviation|Mean
818288|NCT01118325|Primary|IPA Final Extent at 12 Hours Post Dose on Week 4 in Japanese Patients|"Final extent IPA from pre-dose baseline was calculated using the following formula for ADP-induced platelet aggregation:
Percentage Inhibition = 100% x (PAs - PA) / (PAs) PA was the mean response at the given post dose time point and PAs was the mean response at pre dose baseline. Percentage inhibition was restricted to the closed interval [0,100]; any data falling outside this range was truncated to the appropriate limit."|Week 4|Only Japanese participants who had IPA data at Week 4 were considered in this analysis. Arm AZD6140 90 mg bd includes one non-Japanese participant resident in Japan||percentage inhibition||Standard Deviation|Mean
818289|NCT01118325|Primary|IPA Final Extent at 8 Hours Post Dose on Week 4 in Japanese Patients|"Final extent IPA from pre-dose baseline was calculated using the following formula for ADP-induced platelet aggregation:
Percentage Inhibition = 100% x (PAs - PA) / (PAs) PA was the mean response at the given post dose time point and PAs was the mean response at pre dose baseline. Percentage inhibition was restricted to the closed interval [0,100]; any data falling outside this range was truncated to the appropriate limit."|Week 4|Only Japanese participants who had IPA data at Week 4 were considered in this analysis. Arm AZD6140 90 mg bd includes one non-Japanese participant resident in Japan||percentage inhibition||Standard Deviation|Mean
818290|NCT01118325|Primary|IPA Final Extent at 4 Hours Post Dose on Week 4 in Japanese Patients|"Final extent IPA from pre-dose baseline was calculated using the following formula for ADP-induced platelet aggregation:
Percentage Inhibition = 100% x (PAs - PA) / (PAs) PA was the mean response at the given post dose time point and PAs was the mean response at pre dose baseline. Percentage inhibition was restricted to the closed interval [0,100]; any data falling outside this range was truncated to the appropriate limit."|Week 4|Only Japanese participants who had IPA data at Week 4 were considered in this analysis. Arm AZD6140 90 mg bd includes one non-Japanese participant resident in Japan||percentage inhibition||Standard Deviation|Mean
818291|NCT01118325|Primary|Inhibition of Platelet Aggregation(IPA) Final Extent at 2 Hours Post Dose on Week 4 in Japanese Patients|"Final extent IPA from pre-dose baseline was calculated using the following formula for Adenosine Diphosphate (ADP)-induced platelet aggregation:
Percentage Inhibition = 100% x (PAs - PA) / (PAs) Platelet Aggregation (PA) was the mean response at the given post dose time point and PAs was the mean response at pre dose baseline. Percentage inhibition was restricted to the closed interval [0,100]; any data falling outside this range was truncated to the appropriate limit."|Week 4|Only Japanese participants who had IPA data at Week 4 were considered in this analysis. Arm AZD6140 90 mg bd includes one non-Japanese participant resident in Japan||percentage inhibition||Standard Deviation|Mean
818292|NCT01118377|Secondary|Percentage of Participants With a Tumor Response|Tumor response was defined as either a complete response or a partial response prior to failure (disease progression, death from any cause, or a second malignancy). A complete response was defined as the complete disappearance on magnetic response imaging of all enhancing tumor and mass effect on a stable or decreasing dose of dexamethasone (or only receiving adrenal replacement doses) accompanied by a stable or improving neurologic examination that was maintained for at least 12 weeks. A partial response was defined as a greater than or equal to 50% reduction in tumor size by bi-dimensional measurement on a stable or decreasing dose of dexamethasone accompanied by a stable or improving neurologic examination that was maintained for at least 12 weeks.|Baseline to the end of the study (up to 20 weeks)|Intent-to-treat population: All enrolled participants who received at least 1 dose of capecitabine.||Percentage of participants||95% Confidence Interval|Number
818293|NCT01118377|Secondary|Overall Survival|Overall survival was defined as the time from the initiation of therapy to the date of death from any cause or to the date the patient was last known to be alive for surviving patients.|Baseline to the end of the study (up to 20 weeks)|Intent-to-treat population: All enrolled participants who received at least 1 dose of capecitabine.||Months||95% Confidence Interval|Median
818294|NCT01118377|Primary|Progression-free Survival|Progression-free survival was defined as the time from the initiation of treatment to the earliest date of failure (disease progression, death from any cause, or a second malignancy) or to the last assessment date for patients who did not fail. Disease progression was defined as progressive neurologic abnormalities or worsening neurologic status not explained by causes unrelated to tumor progression (eg, anticonvulsant or corticosteroid toxicity, electrolyte disturbances, sepsis, hyperglycemia, weaning of steroids, radiation necrosis, etc); or a greater than 25% increase in the bi-dimensional measurement of the tumor, as compared with the previous scan; or the appearance of a new lesion; or an increase in the doses of dexamethasone required to maintain stable neurologic status or imaging.|Baseline to the end of the study (up to 20 weeks)|Intent-to-treat population: All enrolled participants who received at least 1 dose of capecitabine.||Months||95% Confidence Interval|Median
818295|NCT01118455|Secondary|Number of Subjects With Any Serious Adverse Events by System Organ Class & Preferred Term (Safety Population)|"To compare the safety of Vagus Nerve Stimulation (VNS) treatment using the VNS Therapy device to anti-epileptic drug (AED) therapy in treating patients with seizures.
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm.
Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population."|0-52 weeks|||participants|||Number
818296|NCT01118455|Secondary|Number of Subjects With Any Non-Serious Adverse Events by System Organ Class and Preferred Term (Safety Population)|"To compare the safety of Vagus Nerve Stimulation (VNS) treatment using the VNS Therapy device to anti-epileptic drug (AED) therapy in treating patients with seizures.
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm.
Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population."|0-52 weeks|"Number of participants with any definite related Adverse Event by body system and preferred term, Safety Population.
NOTE: Number of participants analyzed in VNS arm includes one explant not from ITT population, but from safety population."||Participants|||Number
818297|NCT01118455|Secondary|Mean Percent Change in Seizure Frequency (ITT Population)|"The mean percent change in seizure frequency for the VNS and AED treatment groups at 52 weeks post baseline.
Both AED and VNS treatment groups were stratified according to the patients' number of previous AED treatments (early group had 2 to 5 AEDs tested to tolerance or to blood levels at upper end of target range; non-early group had more than 5 AEDs tested to tolerance or to blood levels at upper end of target range). Seizure frequency was calculated based on number of patient/caregiver reported seizures at 52-week post baseline (percentage change in seizure frequency from baseline to the 2-month period prior to the 1-year follow-up of at least 50%). All seizures were counted.
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm.
Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population."|52 weeks post baseline|||Percent Change||Standard Deviation|Mean
818298|NCT01118455|Secondary|Hague Restriction in Childhood Epilepsy Scale (Questionnaire B) (ITT Population)|"Calculate changes in the Hague Restriction in Childhood Epilepsy scale (Carpay et al. 1997) (Questionnaire B) for patients in both treatment arms (AED and VNS) at 52 weeks after randomization compared to baseline. The higher the quality of life score the better the quality of life experienced.
An analysis of variance (ANOVA) model will be used to adjust for baseline variables (including QoL score) when comparing the two treatment groups. A two-sample t-test will be used for simple comparison QoL change from baseline.
Total range for this scale is a minimum score of 10 to a maximum score of 40. There are no applicable subscales."|52 weeks post baseline|||Scores on a Scale||Standard Deviation|Mean
818299|NCT01118455|Secondary|Wellcome Quality of Life Assessment (Questionnaire A) in Epilepsy (ITT Population)|"Calculate changes in the Wellcome Quality of Life Assessment (Parker et al. 1999) (Questionnaire A) for patients in both treatment arms (AED and VNS) at 52 weeks after randomization compared to baseline. The higher the quality of life score the better the quality of life experienced.
An analysis of variance (ANOVA) model will be used to adjust for baseline variables (including QoL score) when comparing the two treatment groups. A two-sample t-test will be used for simple comparison QoL change from baseline.
Total range for this scale is a minimum score of 81 to a maximum score of 336. There are no applicable subscales."|52 weeks post baseline|||Scores on a Scale||Standard Deviation|Mean
818300|NCT01118455|Secondary|Mean Percent Change in Hague Seizure Severity Scale Score (ITT Population)|The Hague Seizure Severity Assessment (Carpay et al. 1996) is a scale completed by the patient and/or caregiver to assess the severity and post-ictal recovery of seizures. A reduction in the HSSA score reflects less seizure severity experienced.|52 weeks post baseline|||Percent Change||Standard Deviation|Mean
818301|NCT01118455|Primary|Proportion of Responders After 1 Year of Follow-up (ITT-population)|Responders are subjects who had no new AEDs added or significant dose changes in baseline AEDs within 1 year of follow-up, along with a reduction in the percentage change in seizure frequency from baseline to the 2-month period prior to the 1-year follow-up of at least 50%.|52 weeks post baseline|Subjects were stratified based on AED therapy history (Early: treated with 2 to 5 AEDs versus Non-early: treated with >5 AEDs).||percentage of responders|||Number
818302|NCT01118624|Secondary|Incidence of Adverse Events (AEs) and Laboratory Abnormalities||Recorded at all study visits: every 2 weeks while on treatment and at safety follow-up (35 +/- 5 days post-last dose) or early termination visit (at time of withdrawal).|||participants|||Number
818303|NCT01118624|Secondary|Overall Survival (OS)|Number of days from first dose of pralatrexate to death.|Assessed at the end of each even-numbered cycle (every 8 weeks), or per standard of care but at least every 4 weeks and no more than every 12 weeks (+/- 1 week) if treatment has ended. OS will be collected for up to 2 years from start of pralatrexate.|||months||95% Confidence Interval|Median
818304|NCT01118624|Secondary|Duration of Response (DOR)|One patient has a PR as response and duration of response was provided for that patient.|Assessed at the end of each even-numbered cycle (every 8 weeks), or per standard of care but no less than 4 weeks and nor more than every 12 weeks (+/- 1 week) if treatment has ended.|||days|||Number
818305|NCT01118624|Primary|Objective Response Rate (ORR)|Tumor response evaluation was performed using RECIST 1.0 using CT/MRI. Proportion of patients achieving a CR or PR is considered in the overall response.|Assessed at the end of each even-numbered cycle (every 8 weeks), or per standard of care but no less than 4 weeks and nor more than every 12 weeks (+/- 1 week) if treatment has ended.|||participants|||Number
818308|NCT01118663|Secondary|To Evaluate the Incidence of Clinical Need for Therapy Beyond the Current 21 Hour FDA Approved Dosing Regimen.|Because the study was terminated prematurely due to lack of enrollment, there was an insufficient sample size to conduct an efficacy analysis.|42 hours|Because the study was terminated prematurely due to lack of enrollment, there was insufficient sample size to conduct efficacy analysis.|||||
818309|NCT01118663|Secondary|To Evaluate the Percentage of Subjects Requiring Continued Therapy|Because the study was terminated prematurely due to lack of enrollment, there was an insufficient sample size to conduct an efficacy analysis.|21 hours|Because the study was terminated prematurely due to lack of enrollment, there was insufficient sample size to conduct efficacy analysis.|||||
818310|NCT01118663|Primary|The Incidence of Hepatoxicity as Measured by the Percentage of Subjects With an Alanine Transaminase (ALT) or Aspartate Transaminase (AST) Value > 1000 U/L Versus Those With an ALT and AST < 1000 U/L|Because the study was terminated prematurely due to lack of enrollment, there was an insufficient sample size to conduct an efficacy analysis.|21 hours|Because the study was terminated prematurely due to lack of enrollment, there was insufficient sample size to conduct efficacy analysis.|||||
818311|NCT01118728|Secondary|Percentage of Participants Who Achieved 20% Response in Ankylosing Spondylitis (AS) Working Group Criteria for Response (ASAS20)|Treatment response for ASAS20 was defined as: Improvement of ≥ 20% and ≥ 1 unit on a 0 (least) to 10 (worst) numerical rating score (NRS) in at least 3 of the 4 ASAS improvement criteria (ASASIC) domains, and no worsening of ≥ 20% and ≥ 1 unit on 0-10 NRS in the remaining domain. The 4 domains included were participant's global disease activity assessment, total back pain, physical function (Bath Ankylosing Spondylitis Functional Index), and Inflammation (mean of last 2 Bath Ankylosing Spondylitis Disease Activity Index questions on morning stiffness).|Baseline up to the end of treatment (60 weeks)|Analysis was performed on safety population. Number of participants analyzed=participants with ASAS20 assessment at specified time-points. Here 'n' signifies number of participants with available data for specified time-point.||Percentage of participants|||Number
818312|NCT01118728|Primary|Percentage of Participants Experiencing Any Treatment-emergent Adverse Event (TEAE), Serious Adverse Event (SAE) and Treatment Discontinuation|An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, regardless of the relationship to the investigational medicinal product (IMP). SAE was any untoward medical occurrence that at any dose resulted in death or was life-threatening or required inpatient hospitalization or prolongation of existing hospitalization or resulted in persistent or significant disability/incapacity or was a congenital anomaly/birth defect or was a medically important event. TEAEs were AEs that developed or worsened or became serious during the TEAE period (time from first dose of IMP up to the end of follow-up period).|Baseline up to the end of study (66 weeks)|Analysis was performed on safety population defined as all participants who received at least one dose of the study treatment after signature of the informed consent.||Percentage of participants|||Number
818315|NCT01118780|Secondary|Time to First Improvement|The time (days) to first improvement, defined as a Clinical Global Impression of Improvement (CGI-Improvement) Score ≤2. Participants who did not have a CGI-I Score ≤2 were censored at the last treatment period visit. CGI-Improvement measured the clinician's perception of the participant's improvement at the time of assessment compared with the start of treatment. Scores could have ranged from 1 (very much improved) to 7 (very much worse). A CGI-Improvement Score of ≤2 was much improved or very much improved.|Baseline through 10 weeks|All randomized participants. The number of participants censored (n)=37 participants in the duloxetine treatment arm and n=58 participants in the placebo treatment arm.||days||95% Confidence Interval|Median
818316|NCT01118780|Secondary|Time to First Functional Remission|Time (days) to first functional remission. Two definitions, using the Sheehan Disability Scale (SDS) Global Functional Impairment Score (SDS Global Score), were used to determine functional remission: Definition 1 (SDS Global Score ≤5 at endpoint) and Definition 2 (SDS Global Score ≤6 at endpoint). Participants, who did not have an SDS Global Score ≤5 or ≤6, were censored at the last treatment period visit. The SDS was a participant-rated questionnaire used to assess the effect of the participant's symptoms on work/school (Item 1), social life/leisure activities (Item 2), and family/home management (Item 3). Each item was rated on a visual analog scale (VAS) from 0 (not at all) to 10 (very severely). The SDS Global Score was the sum of the 3 items and could have ranged from 0 (unimpaired) to 30 (highly impaired). Higher values indicated a higher functional impairment in the participant's work/social/family life.|Baseline through 10 weeks|All randomized participants (pts). Number of pts censored (n)=50 pts in duloxetine treatment arm and n=73 pts in placebo treatment arm for time to first functional remission (SDS Global Score ≤5) and n=37 pts in duloxetine treatment arm and n=60 pts in placebo treatment arm time to first functional remission (SDS Global Score ≤6).||days||95% Confidence Interval|Median
818317|NCT01118780|Secondary|Time to Sustained Improvement Overall|Time (days) to the earliest visit at which the Hamilton Anxiety Rating Scale (HAMA) Total Score was a ≥30% improvement (reduction) from baseline that was sustained through the last treatment period visit. Participants who did not meet sustained improvement criteria were censored at the last treatment period visit. The Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) was used to collect HAMA data. HAMA consisted of 14 items that assessed the severity of anxiety. Each item was scored using a 5-point scale (0=not present to 4=very severe). The HAMA Total Score could have ranged from 0 to 56 and higher scores indicated a greater degree of symptom severity.|Baseline through 10 weeks|All randomized participants. The number of participants censored (n)=43 participants in the duloxetine treatment arm and n=63 participants in the placebo treatment arm.||days||95% Confidence Interval|Median
827180|NCT01202253|Secondary|Percentage of Participants With Other Prior Fungal Infection by Species and Colonization Index||Baseline|Full analysis set included all participants who met the defined eligibility criteria.||percentage of participants|||Number
818318|NCT01118780|Secondary|Time to First Remission|The time (days) to first remission. Two definitions, using the Hamilton Anxiety Rating Scale (HAMA) Total Score, were used to determine remission: Definition 1 (HAMA Total Score ≤7 at endpoint) and Definition 2 (HAMA Total Score ≤10 at endpoint). Participants who did not have remission were censored at the last treatment period visit. The Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) was used to collect HAMA data. The HAMA consisted of 14 items that assessed the severity of anxiety. Each item was scored using a 5-point scale (0=not present to 4=very severe). The HAMA Total Score could have ranged from 0 to 56 and higher scores indicated a greater degree of symptom severity.|Baseline through 10 weeks|All randomized participants (pts). The number of censored pts (n)=72 pts in the duloxetine treatment arm and n=92 pts in the placebo treatment arm for time to first remission (HAMA Total Score ≤7) and n=49 pts in the duloxetine treatment arm and n=71 pts in the placebo treatment arm for the time to first remission (HAMA Total Score ≤10).||days||95% Confidence Interval|Median
818319|NCT01118780|Secondary|Time to First Response|The time (days) to first response, defined as a ≥50% improvement (reduction) from baseline in the Hamilton Anxiety Rating Scale (HAMA) Total Score. Participants who did not have a response were censored at the last treatment period visit. The Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) was used to collect HAMA data. The HAMA consisted of 14 items that assessed the severity of anxiety. Each item was scored using a 5-point scale (0=not present to 4=very severe). The HAMA Total Score could have ranged from 0 to 56 and higher scores indicated a greater degree of symptom severity.|Baseline through 10 weeks|All randomized participants. The number of censored participants (n)=36 participants in the duloxetine treatment arm and n=60 participants in the placebo treatment arm.||days||95% Confidence Interval|Median
818320|NCT01118780|Other Pre-specified|Number of Participants Experiencing a Treatment-Emergent Adverse Event (AE) During the Taper Period|Treatment-emergent AEs were newly occurring AEs or a worsening of AEs during the taper period. A summary of serious AEs and other AEs during the treatment period (baseline through 10 weeks) is located in the Reported Adverse Events module.|2 weeks during the taper period|Randomized participants who entered the taper period.||participants|||Number
818321|NCT01118780|Secondary|Percentage of Participants Reporting Falling Down|The percentage of participants who reported 1 or more falls at or before Week 10.|Baseline through 10 weeks|Randomized participants with no falls recorded at Baseline and at least 1 post-baseline assessment for falls.||percentage of participants|||Number
818322|NCT01118780|Secondary|Adverse Events (AEs) Leading to Discontinuation From Study|The number of participants who discontinued from the study due to an AE (serious or other AE) during the treatment period. A summary of serious and other AEs is located in the Reported Adverse Events module.|Baseline through 10 weeks|All randomized participants.||participants|||Number
818323|NCT01118780|Secondary|Percentage of Participants With Sustained Improvement (Sustained Improvement Rate)|Two definitions, using the Hamilton Anxiety Rating Scale (HAMA) Total Score at endpoint compared with baseline, were used to determine sustained improvement: Definition 1 [sustained improvement overall required a ≥30% improvement (reduction) in the HAMA Total Score at treatment period endpoint, at an earlier visit prior to endpoint, and at all visits in between] and Definition 2 (sustained improvement from Week 2 required a ≥30% reduction at treatment period endpoint, at Week 2, and at all visits in between). Both definitions required at least 2 post-baseline visits. The Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) was used to collect HAMA data. The HAMA consisted of 14 items that assessed the severity of anxiety. Each item was scored using a 5-point scale (0=not present to 4=very severe). The HAMA Total Score could have ranged from 0 to 56 and higher scores indicated a greater degree of symptom severity.|(Baseline through 10 weeks) and (Baseline, Week 2 through Week 10)|Randomized participants who had baseline and the required number of post-baseline HAMA Total Scores.||percentage of participants|||Number
818324|NCT01118780|Secondary|Percentage of Participants With Functional Remission at Week 10 (Functional Remission Rate)|Two definitions, using the Sheehan Disability Scale (SDS) Global Functional Impairment Score (SDS Global Score), were used to determine functional remission: Definition 1 (SDS Global Score ≤5 at endpoint) and Definition 2 (SDS Global Score ≤6 at endpoint). The SDS was a participant-rated questionnaire used to assess the effect of the participant's symptoms on work/school (Item 1), social life/leisure activities (Item 2), and family/home management (Item 3). Each item was rated on a visual analog scale (VAS) from 0 (not at all) to 10 (very severely). The SDS Global Score was the sum of the 3 items and could have ranged from 0 (unimpaired) to 30 (highly impaired). Higher values indicated a higher functional impairment in the participant's work/social/family life.|Week 10|All randomized participants with at least 1 post-baseline SDS Global Score; Last observation carried forward (LOCF).||percentage of participants|||Number
818325|NCT01118780|Secondary|Percentage of Participants With Response or Remission at Week 10 (Response and Remission Rates)|Response was a ≥50% improvement (reduction) in the Hamilton Anxiety Rating Scale (HAMA) Total Score at treatment period endpoint compared with baseline. Two definitions were used to determine remission: Definition 1 (HAMA Total Score ≤7 at endpoint) and Definition 2 (HAMA Total Score ≤10 at endpoint). The Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) was used to collect HAMA data. The HAMA consisted of 14 items that assessed the severity of anxiety. Each item was scored using a 5-point scale (0=not present to 4=very severe). The HAMA Total Score could have ranged from 0 to 56 and higher scores indicated a greater degree of symptom severity.|Baseline, Week 10|Randomized participants with a baseline and 1 post-baseline HAMA Total Score; Last observation carried forward (LOCF).||percentage of participants|||Number
818326|NCT01118780|Secondary|Change From Baseline to Week 10 in Sheehan Disability Scale (SDS) Work/School, Social Life, and Family/Home Management Individual Impairment Scores|The SDS was a participant-rated questionnaire used to assess the effect of the participant's symptoms on work/school (Item 1), social life/leisure activities (Item 2), and family/home management (Item 3). Each item was rated on a visual analog scale (VAS) from 0 (not at all) to 10 (very severely). Higher values indicated a higher functional impairment in the participant's work/social/family life. Least squares (LS) mean were calculated and analyzed using mixed-model repeated measures (MMRM) adjusted for treatment, pooled investigator, age category, visit, treatment-by-visit, baseline score, and baseline-by-visit.|Baseline, Week 10|Randomized participants with a baseline and at least 1 post-baseline SDS Work/School, Social Life/Leisure Activities, or Family/Home Management Individual Impairment Scores.||units on a scale||Standard Error|Least Squares Mean
818327|NCT01118780|Secondary|Number of Participants With Treatment-Emergent Suicide-Related Ideation and Behavior Based on the Columbia Suicide Severity Rating Scale (C-SSRS)|"The C-SSRS captured the occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal ideation: a yes answer to any 1 of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Suicidal behavior: a yes answer to any 1 of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Treatment-emergent was the worsening or new occurrence of suicidal behavior or ideation during treatment compared with baseline (Week 0)."|Baseline through 10 weeks|Randomized participants with a baseline and at least 1 post-baseline C-SSRS Score.||participants|||Number
818328|NCT01118780|Secondary|Change From Baseline to Week 10 in Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) Total Score|The Q-LES-Q-SF was a participant-rated questionnaire designed to assess the degree of enjoyment and satisfaction experienced during the past week. The questionnaire consisted of 16 items rated on a 5-point scale ranging from 1 (very poor) to 5 (very good). The total raw score was the sum of Items 1 to 14 and could have ranged from 14 to 70. Total raw scores were converted to, and expressed as, the percentage of the maximum possible score. Percent=100*(total raw score – 14)/56. Higher scores indicated higher levels of enjoyment/satisfaction. Least squares (LS) mean were calculated and analyzed using analysis of covariance (ANCOVA) adjusted for treatment, pooled investigator, age category, and baseline.|Baseline, Week 10|Randomized participants with a baseline and at least 1 post-baseline Q-LES-Q-SF Total Score; Last observation carried forward (LOCF).||percent of maximum possible score||Standard Error|Least Squares Mean
818329|NCT01118780|Secondary|Change From Baseline to Week 10 in Brief Pain Inventory-Modified Short Form (BPI-SF) Pain Severity and Interference Subscales|The BPI-SF Pain Severity Subscale was a participant-rated questionnaire that measured the severity of pain. Severity scores could have ranged from 0 (no pain) to 10 (pain as bad as you can imagine) for questions assessing worst pain, least pain, and average pain in the past 24 hours, and pain right now. The BPI-SF Interference Subscale measured the interference of pain with the participant's ability to function. Interference scores could have ranged from 0 (does not interfere) to 10 (completely interferes) for questions assessing interference of pain in the past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Least squares (LS) means were calculated and analyzed using mixed-model repeated measures (MMRM) adjusted for treatment, pooled investigator, age category, visit, treatment-by-visit, baseline score, and baseline-by-visit.|Baseline, Week 10|Randomized participants with a baseline and at least 1 post-baseline BPI-SF Pain Severity or Interference Subscale Score.||units on a scale||Standard Error|Least Squares Mean
818330|NCT01118780|Secondary|Patient's Global Impressions of Improvement Scale (PGI-Improvement) at Week 10|PGI-Improvement measured the participant's perception of his or her improvement at the time of assessment compared with the start of treatment. Scores could have ranged from 1 (very much better) to 7 (very much worse). Least squares (LS) mean were calculated and analyzed using mixed-model repeated measures (MMRM) adjusted for treatment, pooled investigator, age category, visit, treatment-by-visit.|Week 10|Randomized participants with at least 1 post-baseline PGI-Improvement Score.||units on a scale||Standard Error|Least Squares Mean
818331|NCT01118780|Secondary|Clinical Global Impressions of Improvement Scale (CGI-Improvement) at Week 10|CGI-Improvement measured the clinician's perception of the participant's improvement at the time of assessment compared with the start of treatment. Scores could have ranged from 1 (very much improved) to 7 (very much worse). Least squares (LS) mean were calculated and analyzed using mixed-model repeated measures (MMRM) adjusted for treatment, pooled investigator, age category, visit, treatment-by-visit.|Week 10|Randomized participants with at least 1 post-baseline CGI-Improvement Score.||units on a scale||Standard Error|Least Squares Mean
818332|NCT01118780|Secondary|Change From Baseline to Week 10 Endpoint in Hospital Anxiety Depression Scale (HADS) Subscale Scores|HADS was a 14-item questionnaire with 2 subscales (anxiety and depression). Each item was rated on a 4-point scale (0 to 3) and higher scores indicated a greater dysfunction. The HADS Anxiety Subscale Score was the sum of the odd numbered items and scores could have ranged from 0 to 21. The HADS Depression Subscale Score was the sum of the even numbered items and scores could have ranged from 0 to 21. Higher scores indicated a greater dysfunction. Least squares (LS) mean were calculated and analyzed using mixed-model repeated measures (MMRM) adjusted for treatment, pooled investigator, age category, visit, treatment-by-visit, baseline score, and baseline-by-visit.|Baseline, Week 10|Randomized participants with a baseline and at least 1 post-baseline HADS Subscale Score.||units on a scale||Standard Error|Least Squares Mean
818333|NCT01118780|Secondary|Change From Baseline to Week 10 in Hamilton Anxiety Rating Scale (HAMA) (Psychic Anxiety Factor Score, Somatic Anxiety Factor Score, and Individual Item Scores: Anxious Mood Item and Tension Item)|The Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) was used to collect HAMA data. The HAMA consisted of 14 items that assessed the severity of anxiety. Each item was scored using a 5-point scale (0=not present to 4=very severe). The HAMA Psychic Anxiety Factor Score was the sum of Items 1 to 6 and Item 14 and could have ranged from 0 to 28. The HAMA Somatic Anxiety Factor Score was the sum of Items 7 to 13 and could have ranged from 0 to 28. The HAMA Anxious Mood Item Score was the score for Item 1 and the HAMA Tension Item Score was the score for Item 2. In each case, higher scores indicated a greater degree of symptom severity. Least squares (LS) mean were calculated and analyzed using mixed-model repeated measures (MMRM) adjusted for treatment, pooled investigator, age category, visit, treatment-by-visit, baseline score, and baseline-by-visit.|Baseline, Week 10|Randomized participants with a baseline and at least 1 post-baseline HAMA factor or item score.||units on a scale||Standard Error|Least Squares Mean
818334|NCT01118780|Secondary|Change From Baseline to Week 10 in Sheehan Disability Scale (SDS) Global Functional Impairment Score|The SDS was a participant-rated questionnaire used to assess the effect of the participant's symptoms on work/school (Item 1), social life/leisure activities (Item 2), and family/home management (Item 3). Each item was rated on a visual analog scale (VAS) from 0 (not at all) to 10 (very severely). The SDS Global Functional Impairment Score (SDS Global Score) was the sum of the 3 items and could have ranged from 0 (unimpaired) to 30 (highly impaired). Higher values indicated a higher functional impairment in the participant's work/social/family life. Least squares (LS) mean were calculated and analyzed using mixed-model repeated measures (MMRM) adjusted for treatment, pooled investigator, age category, visit, treatment-by-visit, baseline score, and baseline-by-visit.|Baseline, Week 10|Randomized participants with a baseline and at least 1 post-baseline SDS Global Functional Impairment Score.||units on a scale||Standard Error|Least Squares Mean
818335|NCT01118780|Primary|Change From Baseline to Week 10 in Hamilton Anxiety Rating Scale (HAMA) Total Score|The Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) was used to collect HAMA data. The HAMA consisted of 14 items that assessed the severity of anxiety. Each item was scored using a 5-point scale (0=not present to 4=very severe). The HAMA Total Score could have ranged from 0 to 56 and higher scores indicated a greater degree of symptom severity. Least squares (LS) mean were calculated and analyzed using mixed-model repeated measures (MMRM) adjusted for treatment, pooled investigator, age category, visit, treatment-by-visit, baseline score, and baseline-by-visit.|Baseline, Week 10|Randomized participants with a baseline and at least 1 post-baseline HAMA Total Score.||units on a scale||Standard Error|Least Squares Mean
818336|NCT01118845|Secondary|The Half-life Period (t1/2) of Unchanged SyB L-0501 in Korea||Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle|||hour||Standard Deviation|Median
818337|NCT01118845|Secondary|The Area Under the Curve (AUC) for Unchanged SyB L-0501 in Korea||Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle|||ng・h/mL||Standard Deviation|Mean
818338|NCT01118845|Secondary|The Maximum Drug Concentration Time (Tmax) of Unchanged SyB L-0501 in Korea||Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle|||hour||Standard Deviation|Median
818339|NCT01118845|Secondary|The Maximum Concentration (Cmax) of Unchanged SyB L-0501 in Korea||Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle|||ng/mL||Standard Deviation|Mean
818340|NCT01118845|Secondary|The Half-life Period (t1/2) of Unchanged SyB L-0501 in Japan||Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle|||hour||Standard Deviation|Median
818341|NCT01118845|Secondary|The Area Under the Curve (AUC) for Unchanged SyB L-0501 in Japan||Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle|||ng・h/mL||Standard Deviation|Mean
818342|NCT01118845|Secondary|The Maximum Drug Concentration Time (Tmax) of Unchanged SyB L-0501 in Japan||Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle|||hour||Standard Deviation|Median
818343|NCT01118845|Secondary|The Maximum Concentration (Cmax) of Unchanged SyB L-0501 in Japan||Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle|||ng/mL||Standard Deviation|Mean
818344|NCT01118845|Secondary|Concomitant Medication Usage||up to 30 weeks|||Participants|||Number
818345|NCT01118845|Secondary|Number of Subjects With Grade ≥3 Physical Examination Finding||up to 30 weeks|||Participants|||Number
818346|NCT01118845|Secondary|Number of Subjects With Abnormality (Grade ≥3) in Laboratory Test Values|"Abnormalities in laboratory test values in overall study period were analyzed. Severity of abnormalities were evaluated using Common Terminology Criteria for Adverse Events (CTCAE).
grade 1 : mild grade 2 : moderate grade 3 : severe grade 4 : life threatening or disabling grade 5 : death related to adverse event"|up to 30 weeks|||Participants|||Number
818347|NCT01118845|Secondary|Number of Adverse Events||up to 30 weeks|||Events|||Number
818348|NCT01118845|Secondary|Number of Subjects With Adverse Event||up to 30 weeks|||Participants|||Number
818349|NCT01118845|Secondary|Progression Free Survival (PFS)|"PFS = day of the first PFS event - day of start of study treatment + 1
The definitions of PFS event are as below.
PD according to overall response on the basis of Revised Response Criteria for Malignant Lymphoma
PD: Any new lesion or increase by ≥50% of previously involved sites from nadir. Nodal masses; Appearance of a new lesion(s) >1.5 cm in any axis, ≥50% increase in SPD of more than one node, or ≥50% increase in longest diameter of a previously identified node >1 cm in short axis. Lesions PET positive if FDG-avid lymphoma or PET positive prior to therapy. Spleen, Liver; ≥50% increase from nadir in the SPD of any previous lesions. Bone marrow; New or recurrent involvement
Disease progression during treatment period
Disease progression during follow up period
Start of treatment of new lesion
Occurrence of other multiple malignant tumors
Death"|up to 30 weeks|||Days||95% Confidence Interval|Median
818350|NCT01118845|Secondary|The Complete Response (CR) Rate Determined on the Basis of Revised Response Criteria for Malignant Lymphoma|"The criteria for CR is as below
Nodal Masses:
fluorodeoxy glucose (FDG)-avid or positron emission tomography (PET) positive prior to therapy; mass of any size permitted if PET negative
Variably FDG-avid or PET negative; regression to normal size on computed tomography (CT)
Spleen, Liver:
Not palpable, nodules disappeared
Bone Marrow:
Infiltrate cleared on repeat biopsy; if indeterminate by morphology, immunohistochemistry should be negative"|up to 30 weeks|||Percentage of participants||95% Confidence Interval|Number
818351|NCT01118845|Primary|The Overall Response Rate [Complete Response (CR) + Partial Response (PR)] Determined on the Basis of Revised Response Criteria for Malignant Lymphoma|"CR: Disappearance of all evidence of disease. PR: Regression of measurable disease and no new sites.
For the criteria for CR, See Outcome measure 2 description.
The criteria for PR is as below.
Nodal Masses:
more than 50% decrease in sum of the product of the perpendicular diameters (SPD) of up to 6 largest dominant masses; no increase in size of other nodes
FDG-avid or PET positive prior to therapy; one or more PET positive at previously involved site
Variably FDG-avid or PET negative; regression on CT
Spleen, Liver:
more than 50% decrease in SPD of nodules (for single nodule in greatest transverse diameter); no increase in size of liver or spleen
Bone Marrow:
Irrelevant if positive prior to therapy; cell type should be specified"|up to 30 weeks|||Percentage of Participants||95% Confidence Interval|Number
818352|NCT01118949|Secondary|Number of Subjects Withdrawn From the Study Due to Treatment Emergent Adverse Events (TEAEs) During the 10-week Treatment Period|An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.|From Visit 2 (Week 4) to Visit 7 (Week 13)|All 49 subjects in the Safety Set (SS) are included in this analysis.||participants|||Number
818353|NCT01118949|Secondary|Number of Subjects With Treatment Emergent Adverse Events (TEAEs) During the 10-week Treatment Period|An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.|From Visit 2 (Week 4) to Visit 7 (Week 13)|All 49 subjects in the Safety Set (SS) are included in this analysis.||participants|||Number
818354|NCT01118949|Secondary|Changes in Count of 3 Hertz (Hz) Spike-wave Discharges (During Waking Hours) on 24-hour Ambulatory Electroencephalogram (EEG) From Visit 2 (Baseline Phase) to Visit 6 (Maintenance Phase)|Subjects were asked to return to the clinic on the morning of the day prior to Visit 2 and Visit 6 to begin 24-hour ambulatory EEG recordings for evaluation of spike-wave discharges. Only subjects with an evaluable EEG measurement with > 19 interpretable hours at Visit 2 and Visit 6 are included in this analysis. The 3 Hertz (Hz) spike-wave discharges are calculated per awake hours.|From Visit 2 (Week 4) to Visit 6 (Week 8)|Of the 49 subjects in the Safety Set (SS), 40 subjects are included in this analysis. Data not available for 9 subjects.||1/hour||Standard Deviation|Mean
818355|NCT01118949|Secondary|Changes in Count of Generalized Spike-wave Discharges on 24-hour Ambulatory Electroencephalogram (EEG) From Visit 2 (Baseline Phase) to Visit 6 (Maintenance Phase)|Subjects were asked to return to the clinic on the morning of the day prior to Visit 2 and Visit 6 to begin 24-hour ambulatory EEG recordings for evaluation of spike-wave discharges. Only subjects with an evaluable EEG measurement with > 19 interpretable hours at Visit 2 and Visit 6 are included in this analysis. The general spike-wave discharges are calculated per interpretable hours.|From Visit 2 (Week 4) to Visit 6 (Week 8)|Of the 49 subjects in the Safety Set (SS), 40 subjects are included in this analysis. Data not available for 9 subjects.||1/hour||Standard Deviation|Mean
818356|NCT01118949|Primary|Change in the Number of Seizure Days With Myoclonic Seizures From the Baseline Phase to the Maintenance Phase|"During the study subjects kept a diary to record daily seizure activity from Visit 1 until the end of study participation. The following information has been recorded:
Seizure type
Seizure frequency
A negative value in change of seizure days with myoclonic seizures shows a decrease in seizure days with myoclonic seizures."|From Baseline Phase (Weeks 0 to 4) to Maintenance Phase (Weeks 8 to 13)|Of the 49 subjects in the Safety Set (SS), 44 are included in this analysis. Data not available for 5 subjects.||number of seizure days||Standard Deviation|Mean
818357|NCT01118949|Primary|Change in the Number of Seizure Days With Absence Seizures From the Baseline Phase to the Maintenance Phase|"During the study subjects kept a diary to record daily seizure activity from Visit 1 until the end of study participation. The following information has been recorded:
Seizure type
Seizure frequency
A negative value in change of seizure days with absence seizures shows a decrease in seizure days with absence seizures."|From Baseline Phase (Weeks 0 to 4) to Maintenance Phase (Weeks 8 to 13)|Of the 49 subjects in the Safety Set (SS), 44 are included in this analysis. Data not available for 5 subjects.||number of seizure days||Standard Deviation|Mean
818358|NCT01118962|Primary|Number of Participants Withdrawn From the Study Due to Treatment-emergent Adverse Events (TEAEs) From Visit 1 to the End of Study (Approximately 61 Weeks)||From Visit 1 to the end of study (Approximately 61 weeks)|"Of the 39 subjects in the Safety Set (SS), 39 were included in this analysis.
The SS consists of all subjects that were dosed at least once with Lacosamide (LCM)."||participants|||Number
818359|NCT01118962|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) From Visit 1 to the End of Study (Approximately 61 Weeks)||From Visit 1 to the end of study (Approximately 61 weeks)|"Of the 39 subjects in the Safety Set (SS), 39 were included in this analysis.
The SS consists of all subjects that were dosed at least once with Lacosamide (LCM)."||participants|||Number
818360|NCT01118975|Primary|Clinical Benefit Rate|The Clinical Benefit Rate is the number of patients with either Complete Response (CR), Partial Response (PR), or Stable Disease (SD) for ≥ 6 months|Radiological evaluations are performed every 12 weeks to determine disease status|||participants|||Number
818361|NCT01118975|Primary|Dose Limiting Toxicities|Safety and tolerability were assessed. Adverse events and dose limiting toxicities were recorded during an escalting dose pilot phase.|6 weeks|||Dose limiting toxicities|||Number
818362|NCT01118988|Secondary|Positive and Negative Affect Scale (PANAS)|"assesses extent to which children have felt a number of positive and negative affects
Positive Affect subscale, 12 items, range: 12-60, higher score = more positive affect Negative Affect subscale, 15 items, range: 15-75, higher score = more negative affect"|2 months|Not all participants who completed the intervention completed this measure, so the numbers reported herein are lower than those reported in Participant Flow.||units on a scale||Standard Deviation|Mean
818363|NCT01118988|Secondary|Child Health Questionnaire - Child Report (CHQ)|"detailed questionnaire about health, daily activites, pain, behavior, family health, self-esteem
Subscales (for all subscales, higher scores = better health):
Behavior - 16 items, averaged, range 1-5 Bodily Pain and Discomfort - 2 items, averaged, range 1-6 Change in Health - 1 item, range 1-5 Family Activities - 6 items, averaged, range 1-5 Family Cohesion - 1 item, range 1-5 Global Health - 1 item, range 1-5 Global Behavior - 1 item, range 1-5 General Health - 12 items, averaged, range 1-5 Mental Health - 16 items, averaged, range 1-5 Physical Functioning - 9 items, averaged, range 1-4 Role/Social Limitations Behavioral - 3 items, range 1-4 Role/Social Limitations Emotional - 3 items, range 1-4 Role/Social Limitations Physical - 3 items, range 1-4 Self-Esteem - 14 items, range 1-5"|2 months|Not all participants who completed the intervention completed this measure, so the numbers reported herein are lower than those reported in Participant Flow.||units on a scale||Standard Deviation|Mean
818364|NCT01118988|Secondary|Beck Depression Inventory 2 (BDI-2) #18|"assesses suicidal ideation and intent
Number reported is number of participants who reported any level of suicidal ideation or intent at any time and who were followed with the study's emergency protocol to ensure that such participants are not a threat to self or others, and that he/she was under the appropriate mental health care."|baseline, weekly weeks 1-8, 2 months, 4 months|Not all participants who completed the intervention completed this measure, so the numbers reported herein are lower than those reported in Participant Flow.||participants|||Number
818365|NCT01118988|Secondary|Revised Child Anxiety and Depression Scale (RCADS) Child Report|"assess levels of symptoms for anxiety disorders and depression
Range: 0-141; Higher scores mean higher symptom level of anxiety and depression"|2 months|Not all participants who completed the intervention completed this measure, so the numbers reported herein are lower than those reported in Participant Flow.||units on a scale||Standard Deviation|Mean
818366|NCT01118988|Secondary|Functional Disability Inventory (FDI)|"assesses functional disability for daily tasks
Range: 0-60; higher scores mean greater functional disability."|2 months|Not all participants who completed the intervention completed this measure, so the numbers reported herein are lower than those reported in Participant Flow.||units on a scale||Standard Deviation|Mean
818367|NCT01118988|Secondary|Emotion Expression Scale for Children (EESC)|"assess child emotional expression/emotion regulation
Poor Awareness subscale, 8 items, range: 8-40; higher scores = poorer emotional awareness Expressive Reluctance subscale, 8 items, range: 8-40; higher scores = more expressive reluctance"|2 months|Not all participants who completed the intervention completed this measure, so the numbers reported herein are lower than those reported in Participant Flow.||units on a scale||Standard Deviation|Mean
818368|NCT01118988|Secondary|Emotion Regulation Questionnaire (ERQ) - Child Answer|"assessment of child emotion regulation
Reappraisal subscale: 6 items, range 6-30, higher scores = higher use of reappraisal Suppression subscale: 4 items, range: 4-20, higher scores = higher use of suppression"|2 months|Not all participants who completed the intervention completed this measure, so the numbers reported herein are lower than those reported in Participant Flow.||units on a scale||Standard Deviation|Mean
818369|NCT01118988|Secondary|Health Belief Scale (HBS) Short Version - Child Report|Number of treatment modalities rated 1-4 by participants on the HBS questionnaire, which asked participants to rate how much they think each of 16 listed treatment modalities would help with pain (1=Completely, 2=A lot, 3=Some, 4=A little, 5=Not at all).|2 months|Not all participants who completed the intervention completed this measure, so the numbers reported herein are lower than those reported in Participant Flow.||Number of treatments||Standard Deviation|Mean
818370|NCT01118988|Secondary|Child Anxiety Sensitivity Inventory (CASI) - Child Report|"Assessment of child's anxiety sensitivity
18 items, range 18-54, higher scores = more anxiety sensitivity"|2 months|Not all participants who completed the intervention completed this measure, so the numbers reported herein are lower than those reported in Participant Flow.||units on a scale||Standard Deviation|Mean
818371|NCT01118988|Secondary|Child Symptom Inventory (CSI)|"Assement of somatic symptom complaints
24 items, range 0-96, higher score = more somatic symptoms"|2 months|Not all participants who completed the intervention completed this measure, so the numbers reported herein are lower than those reported in Participant Flow.||units on a scale||Standard Deviation|Mean
818372|NCT01118988|Secondary|Pittsburgh Sleep Quality Index (PSQI)|"assessment of sleep quality
Range: 0-21; higher scores = lower sleep quality"|2 months|Not all participants who completed the intervention completed this measure, so the numbers reported herein are lower than those reported in Participant Flow.||units on a scale||Standard Deviation|Mean
818373|NCT01118988|Secondary|Body Map and Pain Assessment|"visual depiction of body pain and associated pain ratings over certain periods of time and conditional situations
Range: 0-19 body areas"|2 months|Not all participants who completed the intervention completed this measure, so the numbers reported herein are lower than those reported in Participant Flow.||Number of painful body areas||Standard Deviation|Mean
818374|NCT01118988|Primary|Adherence to Physician Recommended CAM Therapies|This measure tracks the attendance of CAM therapies recommended by the subjects' pain specialist physician.|post intervention (week 8)|One participant in the Mentorship group did not do the weekly CAM therapy tracking and is thus not included in the results for this measure.||Visits to CAM therapists per week||Standard Deviation|Mean
818375|NCT01125800|Primary|Percentage of Participants With Objective Response Rate (ORR) by Treatment|The tumor response to the sonidegib treatment was measured by ORR. The ORR was defined as the percentage of participants with partial response or complete response as their best overall response. Participants with stable disease, progressive disease tumor assessment were considered as non-responders. Response evaluation criteria was gadolinium chelate-enhanced brain tumor magnetic resonance imaging (Gd-MRI) for Medulloblastoma and central nervous system (CNS) tumors and response evaluation criteria in solid tumors (RECIST) version 1.0 for non-CNS tumors assessed by MRI. Complete Response (CR), Progressive Disease (PD) and Incomplete Response/Stable Disease (SD) were defined as disappearance of all non-target lesions, unequivocal progression of existing non-target lesions and Neither CR nor PD, respectively.|Baseline, Day 28 of Cycle 2, End of treatment (Within 14 days of last dose)|The analysis was performed in full analysis set (FAS), defined as all the participants who received at least one dose of sonidegib.||Percentage of participants|||Number
818376|NCT01125800|Secondary|Duration of Response by Treatment|Duration of overall response (complete response (CR) or partial response (PR)) was calculated for those participants whose best overall response was CR or PR. The start date was the date of the first documented tumor response (CR or PR) and the end date was the date of the event defined as the first documented progression or death due to underlying cancer or after the same treatment line. If a participant did not have a progression or death, the duration of response was censored at the date of last adequate tumor assessment in that treatment line.|Baseline, Day 28 of Cycle 2, End of treatment (Within 14 days of last dose)|"The analysis was performed in FAS population. Here Number of participants analysed” signifies treatment responders for the specified reporting group."||months||Full Range|Median
818377|NCT01125800|Secondary|Percentage of Pediatric Participants With Objective Response Rate (ORR) by Hedgehog (Hh) Signaling Pathway Status|ORR was determined in the participants with mutations on Hh gene (Hh positive) and the participants without mutations on Hh gene (Hh negative).|Baseline, Day 28 of Cycle 2, End of treatment (Within 14 days of last dose)|60 patients with known (Hedgehog) Hh pathway activation status were analyzed, 10 patients, including all 5 patients with an objective response (3 with pediatric) , were Hh-positive (+). No Hh-negative patient had an objective response.||% pediatric Hh + responders|||Number
818378|NCT01125800|Secondary|Maximum Observed Plasma Concentration (Cmax) of Sonidegib in Phase I|Maximum observed plasma concentration following drug administration was calculated from the raw plasma concentration time data.|Pre-dose, 0.5, 1, 2, 4, 7 hours (± 15 min) post-dose at Day 1 and Day 22 of Cycle 1|The analysis was performed in PAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||nanograms/millitres(ng/mL)||Standard Deviation|Mean
818379|NCT01125800|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Sonidegib in Phase I|Tmax was defined as the time required to reach maximum observed plasma concentration. Tmax was directly determined from the raw plasma concentration time data.|Pre-dose, 0.5, 1, 2, 4, 7 hours (± 15 min) post-dose at Day 1 and Day 22 of Cycle 1|The analysis was performed in PAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||hours||Full Range|Median
818393|NCT01125930|Secondary|Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Presence of Flushing|Evaluation of erythematotelangiectatic rosacea symptoms includes subject reporting of flushing, burning, stinging, topical product intolerance|2, 6, 12, 18 weeks|LOCF, Complete-Case ITT Population||participants|||Number
818380|NCT01125800|Secondary|Area Under the Drug Concentration Time Curve From Time Zero to 24 Hours After Dosing (AUC0-24h) of Sonidegib in Phase I|AUC(0-24h) was defined as the area under the drug concentration time curve calculated using linear trapezoidal summation from time zero to 24 hours after dosing.|Pre-dose, 0.5, 1, 2, 4, 7 hours (± 15 min) post-dose at Day 1 and Day 22 of Cycle 1|The analysis was performed in pharmacokinetic analysis set (PAS), defined as all the participants who received at least one (full or partial) dose of sonidegib and provided at least one evaluable pharmacokinetic (PK) blood sample. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||nanograms*hours/millilitres (ng*hr/mL)||Standard Deviation|Mean
818381|NCT01125800|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs and Death During the Study|An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. A SAE was defined as an event which was fatal or life threatening, required or prolonged hospitalization, was significantly or permanently disabling or incapacitating, constituted a congenital anomaly or a birth defect, or encompassed any other clinically significant event that could jeopardize the participant or require medical or surgical intervention to prevent one of the aforementioned outcomes. Treatment related AEs were defined as AEs that were suspected to be related to study treatment as per investigator. On-treatment deaths were deaths which occurred up to 30 days after last date of study treatment.|Baseline (start of study treatment) up to End of treatment (Within 14 days of last dose)|The analysis was performed in safety set (SS), defined as all the participants who received at least 1 dose of sonidegib.||participants|||Number
818382|NCT01125800|Primary|Maximum Tolerated Dose (MTD) of Sonidegib for Prolonged Use|MTD was defined as highest dose level for which no more than 1 participant in a dose cohort experienced dose-limiting toxicity (DLT), based on Bayesian logistic regression model (BLRM) employing the escalation with overdose control (EWOC) principle. DLT was defined as an adverse event (AE) or abnormal laboratory value assessed as unrelated to disease, disease progression, intercurrent illness, or concomitant medications.k|Baseline, End of dose escalation part (Day 42)|The MTD for the pediatric population was not established in this study. MTD was not achieved since 1 or no DLT was observed. The recommended phase II dose was established based on the safety, pharmacokinetics, and clinical responses observed.||mg/m^2|||Number
818383|NCT01125800|Primary|Number of Participants With Dose-limiting Toxicities (DLT) in Phase I|DLT was defined as an adverse event (AE) or abnormal laboratory value assessed as unrelated to disease, disease progression, intercurrent illness, or concomitant medications. DLT included any grade 3 or 4 clinically-evident toxicity, Hematology: ≥ CTCAE grade 3 neutropenia (ANC <1.0x10^9/L); ≥ CTCAE grade 3 thrombocytopenia (platelets <50x10^9/L); ≥ CTCAE grade 3 anemia (Hgb <80 g/L); Febrile neutropenia (ANC <1x10^9/L, fever ‡ 38.5°C), Renal: ≥ CTCAE grade 3 serum creatinine (>3xULN), Hepatic: ≥ CTCAE grade 3 total bilirubin (>3xULN); ≥ 10xULN ALT elevation; grade 2 total bilirubin (>1.5ULN) together with ≥ grade 3 ALT elevation (>5xULN), Cardiac: ≥ CTCAE grade 3, Other AEs: ≥ CTCAE grade 3 vomiting or nausea despite optimal antiemetic therapy, diarrhea despite optimal antidiarrheal treatment.|Baseline, End of dose escalation part (Day 42)|The analysis was performed in full analysis set (FAS), defined as all the participants who received at least one dose of sonidegib.||participants|||Number
818384|NCT01125813|Primary|Efficacy of Treating Bleeding Episodes|"At the end of a bleeding episode, efficacy was assessed as:
Excellent: Abrupt pain relief and/or unequivocal improvement in objective signs of bleeding within approximately 8 hours after a single infusion
Good: Definite pain relief and/or improvement in signs of bleeding within approximately 8-12 hours after an infusion requiring up to 2 infusions for complete resolution
Moderate: Probable or slight beneficial effect within approximately 12 hours after the first infusion requiring more than two infusions for complete resolution
None: No improvement within 12 hours, or worsening of symptoms, requiring more than 2 infusions for complete resolution Efficacy was rated"|After each bleeding episode, up to 6 month|||Percentage of treatments|bleeding episodes||Number
818385|NCT01125813|Primary|Efficacy Assessment After a Total of at Least 50 EDs Per Subject at the End of the Study at 6 Months|Frequency of spontaneous breakthrough bleeds/months under prophylactic treatment.|At least 50 Exposure Days and at least 6 months|All subjects who started prophylactic treatment were evaluated.||Bleeds per month||Standard Deviation|Mean
818386|NCT01125917|Primary|Number of Participants With Adverse Events (AEs) as a Measure of Safety|The purpose of the extension phase was to evaluate the long-term safety and tolerability of BTDS in subjects who had participated in the core study (BUP3015).|52-week extension phase|The Extension Safety Population (N = 354) consisted of all subjects who received at least 1 dose of the open-label BTDS extension study drug, and had at least 1 safety assessment during the extension phase.||participants|||Number
818387|NCT01125930|Secondary|Skin Irritation Assessed by Facial Burning Upon Product Application||2, 6, 12, 18 weeks|LOCF, Complete-Case ITT Population One subject did not complete the product assessment questionnaire at week 2 visit.||participants|||Number
818388|NCT01125930|Secondary|Skin Irritation Assessed by Facial Itching Upon Product Application||2, 6, 12, 18 weeks|LOCF, Complete-Case ITT Population One subject did not complete the product assessment questionnaire at week 2 visit.||participants|||Number
818389|NCT01125930|Secondary|Skin Irritation Assessed by Facial Stinging Upon Product Application||2, 6, 12, 18 weeks|LOCF, Complete-Case ITT Population One subject did not complete the product assessment questionnaire at week 2 visit.||participants|||Number
818390|NCT01125930|Secondary|Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Product Assessment|Evaluation of erythematotelangiectatic rosacea symptoms includes subject reporting of flushing, burning, stinging, topical product intolerance|2, 6, 12, 18 weeks|LOCF, Complete-Case ITT Population One subject did not complete the product assessment questionnaire at week 2 visit.||participants|||Number
818391|NCT01125930|Secondary|Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging|Evaluation of erythematotelangiectatic rosacea symptoms includes subject reporting of flushing, burning, stinging, topical product intolerance|2, 6, 12, 18 weeks|LOCF, Complete-Case ITT Population||participants|||Number
818392|NCT01125930|Secondary|Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning|Evaluation of erythematotelangiectatic rosacea symptoms includes subject reporting of flushing, burning, stinging, topical product intolerance|2, 6, 12, 18 weeks|LOCF, Complete-Case ITT Population||participants|||Number
818396|NCT01125930|Secondary|Severity of Erythematotelangiectatic Signs: Telangiectasia|Severity of erythematotelangiectatic signs include redness (non-transient erythema), telangiectasia, facial edema, and dry skin.|2, 6, 12, 18 weeks|LOCF, Complete-Case ITT Population||participants|||Number
818397|NCT01125930|Primary|Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Assessment of Product|Severity of erythematotelangiectatic rosacea symptoms was assessed by asking subjects to give an overall self-assessment of product tolerance.|24 weeks|LOCF, Complete-Case ITT Population||participants|||Number
818398|NCT01125930|Primary|Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging|Severity of erythematotelangiectatic rosacea symptoms was assessed by asking subjects to rate the Facial Stinging feature of their rosacea.|24 weeks|LOCF, Complete-Case ITT Population||participants|||Number
818399|NCT01125930|Primary|Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning|Severity of erythematotelangiectatic rosacea symptoms was assessed by asking subjects to rate the facial burning feature of their rosacea.|24 weeks|LOCF, Complete-Case ITT Population||participants|||Number
818400|NCT01125930|Primary|Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Presence of Flushing|"Flushing is defined as a temporary redness of the face, neck and chest. Subjects were asked to choose the best answer that applied to them in response to the questions Do you have flushing?."|24 weeks|LOCF, Complete Case ITT Population||participants|||Number
818401|NCT01125930|Primary|Severity of Erythematotelangiectatic Rosacea Signs: Dry Skin|Severity of erythematotelangiectatic rosacea signs will be measured by taking into account the following: redness, telangiectasia, facial edema, dry skin|24 weeks|LOCF, Complete-Case ITT Population||participants|||Number
818402|NCT01125930|Primary|Severity of Erythematotelangiectatic Rosacea Signs: Facial Edema|Severity of erythematotelangiectatic rosacea signs will be measured by taking into account the following: redness, telangiectasia, facial edema, dry skin|24 weeks|LOCF, Complete-Case ITT Population||participants|||Number
818403|NCT01125930|Secondary|Severity of Erythematotelangiectatic Signs: Non-Transient Erythema (Redness)|Severity of erythematotelangiectatic signs include redness (non-transient erythema), telangiectasia, facial edema, and dry skin.|2, 6, 12, 18 weeks|LOCF, Complete-Case ITT Population||participants|||Number
818404|NCT01125930|Secondary|Molecular Evidence of Photodamage|These will be evaluated from skin biopsies from some subjects at baseline and final evaluation at 24 weeks. Gene expression data were normalized and presented as fold change from baseline to week 24 visit. Markers of photodamage include Collagen 1 (COL-1), Collagen 3 (COL-3), Matrix Metalloproteinase 1 (MMP1), Matrix Metalloproteinase 3 (MMP3), and Matrix Metalloproteinase 9 (MMP9).|24 weeks|ITT Population that completed baseline and week 24 biopsies||fold change||Standard Deviation|Mean
818405|NCT01125930|Secondary|Molecular Markers of Inflammation|These will be evaluated from skin biopsies from some subjects at baseline and final evaluation at 24 weeks. Gene expression data were normalized and presented as fold change from baseline to week 24 visit. Markers of inflammation include Tachykinin 1 (TAC1), CXC Motif Receptor 4 (CXCR4), CXC Motif Ligand 12 (CXCL12), and Tumor Necrosis Factor Alpha (TNFa).|24 weeks|ITT Population that completed baseline and Week 24 biopsies||fold change||Standard Deviation|Mean
818406|NCT01125930|Secondary|Signs of Other Rosacea Subtypes: Papulopustular|Signs of other rosacea subtypes includes papulopustular, inflammatory papule count|2, 6, 12, 18, 24 weeks|LOCF, Complete-Case ITT Population||inflammatory papule||Standard Deviation|Mean
818407|NCT01125930|Secondary|Signs of Other Rosacea Subtypes: Phymatous Changes of Rosacea|Signs of other rosacea subtypes using rosacea clinical scores: phymatous changes of rosacea|2, 6, 12, 18 and 24 weeks|LOCF, Complete-Case ITT Population||participants|||Number
818408|NCT01125930|Secondary|Signs of Other Rosacea Subtypes: Ocular Manifestations of Rosacea|Signs of other rosacea subtypes using rosacea clinical scores: ocular manifestations of rosacea|2, 6, 12, 18 and 24 weeks|LOCF, Complete-Case ITT Population||participants|||Number
818409|NCT01125930|Secondary|Photodamage|Photodamage was measured at baseline and Week 24 visits using the nine point Hamilton-Griffiths Photoaging Score categories. The categories were developed using photographs of subject representing grades of photodamge from none (0) to severe (8). A direct comparison is made between the subject and the photographic standards. If an exact match cannot be made, the interstandard scores (1, 3, 5, 7) are used.|24 weeks|LOCF, Complete-Case ITT Population||participants|||Number
818410|NCT01125930|Secondary|Quality of Life|The Dermatology Life Quality Index (DLQI) questionnaire was given at each visit. It involves 10 questions that relate to symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment. The total DLQI score is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.|2, 6, 12, 18, 24 weeks|LOCF, Complete-Case ITT Population||units on a scale||Standard Deviation|Mean
818411|NCT01125930|Primary|Severity of Erythematotelangiectatic Rosacea Signs: Telangiectasia|Severity of erythematotelangiectatic rosacea signs will be measured by taking into account the following: redness, telangiectasia, facial edema, dry skin|24 weeks|LOCF, Complete-Case ITT population||participants|||Number
818412|NCT01125930|Primary|Severity of Erythematotelangiectatic Rosacea Signs: Redness (Non Transient Erythema)|Severity of erythematotelangiectatic rosacea signs will be measured by taking into account the following: redness, telangiectasia, facial edema, dry skin|24 weeks|Last Observation Carried Forward (LOCF), Complete-Case Intent-to-Treat (ITT) Population||participants|||Number
818413|NCT01126060|Primary|Postoperative Drainage Amount|method : measurement of drainage fluids from negative suction system every 8 hr until daily total amount reduces under 20mL|serial measurement from 1day to 4day after surgery|||mL||Standard Deviation|Mean
818414|NCT01126099|Secondary|Days in Study|The number of days participants remained in the study during the Double Blind Phase. Please note that although the length of follow-up designated in the protocol was 12 weeks, a number of participants were in this phase longer (e.g. the dose titration phase took longer than 3 weeks, assessments were delayed due to scheduling conflicts, etc.) Therefore the length of time in the Double Blind Phase can exceed 12 weeks (84 days).|12 weeks after Baseline|7 participants in the prazosin group were in the double-blind phase longer than 12 weeks (84 days). 4 participants in the placebo group were in the double-blind phase longer than 12 weeks (84 days).||days||Standard Deviation|Mean
820249|NCT01142323|Secondary|Mayo Risk Score for Primary Sclerosing Cholangitis|The Mayo risk score, which is a composite of several variables (age, bilirubin, albumin, aspartate aminotransferase[AST] and h/o variceal bleeding), will be measured at entry and end of study|6 months||||||
818415|NCT01126099|Primary|Change in Neuropsychiatric Inventory Score|Neuropsychiatric Inventory score change from Baseline to last observation.The Neuropsychiatric Inventory is a scale that quantifies behavioral and psychiatric symptoms in patients with dementia. The scale ranges from 0 to 144, with 0 being no symptoms.|12 weeks|One study participant in the Placebo group dropped out prior to first follow-up, although this subject is included in the statistical analysis to provide information on the outcome at baseline.||units on a scale||Standard Deviation|Mean
818416|NCT01126099|Secondary|Change in Brief Psychiatric Rating Scale Total Score|Brief Psychiatric Rating Scale score change from Baseline to last observation. The Brief Psychiatric Rating Scale measures 18 psychiatric symptom domains. The scale ranges from 18 to 126, where 18 indicates no psychiatric symptoms.|12 Weeks after Baseline|One study participant in the Placebo group dropped out prior to first follow-up, although this subject is included in the statistical analysis to provide information on the outcome at baseline.||units on a scale||Standard Deviation|Mean
818417|NCT01126099|Primary|Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change|This scale represents the raters overall impression of improvement or worsening, and is assessed at the last visit. 1 = Marked improvement, 1 = Moderate improvement, 3 = Minimal improvement, 4 = No change, 5 = Minimal worsening, 6 = Moderate worsening, 7 = Marked worsening.|12 Weeks after Baseline|Any participant who had at least one follow-up assessment was included in the analysis. One participant in the Placebo group did not return for follow-up, and therefore was not included in the analysis.||units on a scale||Standard Deviation|Mean
818418|NCT01126359|Secondary|Break-through Narcotic Requirement|Patient break-through narcotic requirements in morphine equivalents are 0.2 mg of dilaudid = 1 mg of morphine, iv., used during and after VAC dressing change.|20 minutes|||Narcotic Requirements (mg)||95% Confidence Interval|Mean
818419|NCT01126359|Primary|Visual Analog Scale Pain Score|Visial Analog Pain Scores (VAS) range from 0 (no pain) - 10 (worst pain ever). Visial Analog Pain Scores are determined at each pain measurement time point (during/after VAC dressing removal).|20 minutes|||Visial Analog Pain Score (VAS)||95% Confidence Interval|Mean
818426|NCT01126437|Secondary|Time to Death From Major Adverse Cardiovascular Event (MACE)|The results presented below are number of patients with death from MACE.|Up to 3 years|TS including vital status follow−up, DAS||Number of deaths from MACE|||Number
818427|NCT01126437|Secondary|Time to Onset of First Major Adverse Cardiovascular Event (MACE)|Time to onset of first major adverse cardiovascular event (MACE). MACE was defined as: Fatal event in the system organ classes of cardiac and vascular disorders, Preferred terms: sudden death, cardiac death, sudden cardiac death, Outcome events of myocardial infarction (serious and non-serious), Outcome events of stroke (serious and non-serious) and Outcome events of TIA (serious and non-serious). The results presented below are for the number of patients with MACE.|Up to 3 years|Treated set - on treatment only||number of patients with MACE|||Number
818428|NCT01126437|Secondary|Time to First Moderate to Severe COPD Exacerbation|"COPD exacerbation defined as a complex of lower respiratory events/symptoms (increase of new onset) related to the underlying COPD, with duration of three days or more, requiring a change in treatment where a complex of lower respiratory event/symptoms was defined as having at least two of the following: shortness of breath, sputum production (volume), occurrence of purulent sputum, cough, wheezing, chest tightness and where a required change in treatment includes the following:Prescription of antibiotics and/or systemic steroids, and/or a newly prescribed maintenance respiratory medication (i.e., bronchodilators including theophyllines).
Exacerbations classified as follows:
Mild:a new prescription of maintenance bronchodilator only Moderate:antibiotics or systemic steroids without hospitalization Severe:hospitalization.
Results presented below are number of patients with moderate to severe exacerbations."|Up to 3 years|treated set - on treatment only||number of patients with event|||Number
818429|NCT01126437|Secondary|Number of Hospitalizations Associated With COPD Exacerbation|Total number of hospitalizations associated with COPD exacerbation.|Up to 3 years|treated set - on treatment only||number of hospitalizations|||Number
818430|NCT01126437|Secondary|Time to First Hospitalization Associated With COPD Exacerbation|The results presented below are for the patients with hospitalizations due to COPD exacerbations.|Up to 3 years|treated set - on-treatment only||Number of patients with event|||Number
818431|NCT01126437|Secondary|Number of COPD Exacerbations|"The number of COPD exacerbations. COPD exacerbation defined as a complex of lower respiratory events/symptoms (increase of new onset) related to the underlying COPD, with duration of three days or more, requiring a change in treatment where a complex of lower respiratory event/symptoms was defined as having at least two of the following: shortness of breath, sputum production (volume), occurrence of purulent sputum, cough, wheezing, chest tightness and where a required change in treatment includes the following:Prescription of antibiotics and/or systemic steroids, and/or a newly prescribed maintenance respiratory medication (i.e., bronchodilators including theophyllines)."|Up to 3 years|Treated Set - on treatment only||number of COPD exacerbations|||Number
818432|NCT01126437|Secondary|Trough FEV1 Over 120 Weeks (in a Substudy of 1370 Patients)|Trough forced expiratory volume in one second (FEV1) over 120 weeks (in a substudy of 1370 patients)|Up to 3 years|SSS - PFT - Sub-study set (pulmonary function testing). This analysis set included all subjects in the TS who signed informed consent to participate in the spirometry sub-study and had at least baseline and one on-treatment trough FEV1.||Liter||Standard Error|Least Squares Mean
818433|NCT01126437|Primary|Time to First COPD Exacerbation|"Defined as a complex of lower respiratory events/symptoms (increase of new onset) related to the underlying COPD, with duration of three days or more, requiring a change in treatment where a complex of lower respiratory event/symptoms was defined as having at least two of the following: shortness of breath, sputum production (volume), occurrence of purulent sputum, cough, wheezing, chest tightness and where a required change in treatment includes the following:Prescription of antibiotics and/or systemic steroids, and/or a newly prescribed maintenance respiratory medication (i.e., bronchodilators including theophyllines).
Onset of exacerbation was defined by the onset of first recorded symptom. The end of exacerbation was decided by the investigator based on clinical judgement.
Exacerbations were classified as follows:
Mild:a new prescription of maintenance bronchodilator only Moderate:antibiotics or systemic steroids without hospitalization Severe:hospitalization."|Up to 3 years|Treated set (TS, on-treatment only)||days to event||95% Confidence Interval|Median
818434|NCT01126437|Primary|Time to All-Cause Mortality|Number of patients with all-cause mortality|Up to 3 years|Death analysis set (DAS) including vital status follow-up: This analysis set included all randomized subjects excluding only subjects who were documented as not treated.||Number of deaths|||Number
818435|NCT01126541|Secondary|Change From Baseline in Patient Global Assessment of Pain in Participants With MCII|"The participants assessed their pain over the past 24 hours on a 0 to 100 mm horizontal VAS. The left-hand extreme of the line equals 0 mm, and is described as “no pain” and the right-hand extreme equals 100 mm as “unbearable pain. Participants were asked to mark the line and the distance from the left edge was measured. Higher values correspond to worst state of participant (high pain levels)."|Baseline, Week 24, 12 and 24 weeks after 1st retreatment|ITT population; only participants with MCII were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.||mm||Standard Deviation|Mean
818436|NCT01126541|Secondary|Percentage of Participants With MCII in Pain|Participants were asked how their pain had been during the last 48 hours compared to baseline. Those participants that reported improvement assessed how important this improvement was to them; range: very important, moderately important, slightly important, or not at all important. Binary response options: 1=improved very important, or improved moderately important; 2=slightly important, not at all important, no change, or worse pain.|Week 24, 12 and 24 weeks after 1st retreatment|ITT population; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
818437|NCT01126541|Secondary|Patient Global Assessment of Pain in Participants Reporting Acceptable Symptoms Using PASS|Patient Global Assessment of Pain assessed in participants reporting acceptable symptom state using PASS (acceptance to remain for the rest of their lives with the level of pain they had during the last 48 hours) on a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as “no pain” and the right-hand extreme equals 100 mm as “unbearable pain”. Higher values correspond to worst state of participant (high pain levels).|Week 24, 12 and 24 weeks after 1st retreatment|ITT population; only participants with 'acceptable' symptom state assessed using PASS were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.||mm||Standard Deviation|Mean
818438|NCT01126541|Secondary|Percentage of Participants With Acceptable Symptom State in Pain Assessed Using PASS|"Percentage of participants reporting acceptable symptom state: acceptance to remain for the rest of their lives with the level of pain they had during the last 48 hours; and unacceptable symptom state: not able to remain for the rest of their lives with the level of pain they had during the last 48 hours. In the case of missing data, participants who withdrew from the study because of inefficacy or toxicity were considered unacceptable."|Week 24, 12 and 24 weeks after 1st retreatment|ITT population||percentage of participants|||Number
818439|NCT01126541|Secondary|Change From Baseline in HAQ-DI in Participants With MCII|HAQ-DI was assessed in participants with MCII. HAQ-DI is a participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0=least difficulty and 3 extreme difficulty.|Baseline, Week 24, 12 and 24 weeks after 1st retreatment|ITT population; only participants with MCII were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.||units on a scale||Standard Deviation|Mean
818440|NCT01126541|Secondary|Percentage of Participants With MCII in Functioning|Participants were asked how their functioning had been during the last 48 hours compared to baseline. Those participants that reported improvement assessed how important this improvement was to them; range: very important, moderately important, slightly important, or not at all important. Binary response options: 1=improved very important, or improved moderately important; 2=slightly important, not at all important, no change, or worse.|Week 24, 12 and 24 weeks after 1st retreatment|ITT population||percentage of participants|||Number
818441|NCT01126541|Secondary|HAQ-DI Scores in Participants Reporting Acceptable Function Using PASS|HAQ-DI was assessed in participants reporting acceptable symptom state using PASS (acceptance to remain for the rest of their lives with the level of disease activity they had during the last 48 hours). HAQ-DI is a participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0=least difficulty and 3 extreme difficulty.|Week 24, 12 and 24 weeks after 1st retreatment|ITT population; only participants with 'acceptable' symptom state assessed using PASS were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.||units on a scale||Standard Deviation|Mean
818442|NCT01126541|Secondary|Percentage of Participants Reporting Acceptable Symptom State in Functioning Assessed Using PASS|"Percentage of participants reporting acceptable symptom state: acceptance to remain for the rest of their lives with the level of function they had during the last 48 hours; and unacceptable symptom state: not able to remain for the rest of their lives with the level of function they had during the last 48 hours. In the case of missing data, participants who withdrew from the study because of inefficacy or toxicity were considered unacceptable."|Week 24, 12 and 24 weeks after 1st retreatment|ITT population||percentage of participants|||Number
818443|NCT01126541|Secondary|Change From Baseline in Patient Global Assessment of Disease Activity in Participants With MCII|The Patient's Global Assessment of Disease Activity was assessed in participants reporting MCII on a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm as “maximum disease activity” (maximum arthritis disease activity). Higher values correspond to worst state of participant (high disease activity).|Baseline, Week 24, 12 and 24 weeks after 1st retreatment|ITT population; only participants with MCII were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.||mm||Standard Deviation|Mean
818834|NCT01122576|Secondary|Binocular Halo and Starburst|Halo and starburst (both monocular and binocular) were measured using a glarometer on integer scales of 1-5, where the smaller the number the better the outcome.|Visit 3 (2-3 months)|Full Analysis Set||units on a scale||Standard Deviation|Mean
818444|NCT01126541|Secondary|Percentage of Participants With Minimum Clinically Important Improvement (MCII) in Disease Activity|Participants were asked how their disease activity had been during the last 48 hours compared to baseline. Those participants that reported improvement assessed how important this improvement was to them; range: very important, moderately important, slightly important, or not at all important. Binary response options: 1=improved very important, or improved moderately important; 2=slightly important, not at all important, no change, or worse-more disease activity.|Week 24, 12 and 24 weeks after 1st retreatment|ITT population||percentage of participants|||Number
818445|NCT01126541|Secondary|Patient Global Assessment of Disease Activity in Participants Reporting Acceptable Symptoms Using PASS|The Patient's Global Assessment of Disease Activity assessed in participants reporting acceptable symptom state using PASS (acceptance to remain for the rest of their lives with the level of disease activity they had during the last 48 hours) on a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm as “maximum disease activity” (maximum arthritis disease activity). Higher values correspond to worst state of participant (high disease activity).|Week 24, 12 and 24 weeks after 1st retreatment|ITT population; only participants with 'acceptable' symptom state assessed using PASS were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.||mm||Standard Deviation|Mean
818446|NCT01126541|Secondary|Percentage of Participants Reporting Acceptable Disease Activity Symptom State Assessed Using Patient Acceptable and Unacceptable Symptom State (PASS)|"Percentage of participants reporting acceptable symptom state: acceptance to remain for the rest of their lives with the level of disease activity they had during the last 48 hours; and unacceptable symptom state: not able to remain for the rest of their lives with the level of disease activity they had during the last 48 hours. In the case of missing data, participants who withdrew from the study because of inefficacy or toxicity were considered unacceptable."|Week 24, 12 and 24 weeks after 1st retreatment|ITT population||percentage of participants|||Number
818447|NCT01126541|Secondary|Medical Outcomes Study Sleep Scale (MOS-Sleep) Composite Sleep Problems 6 (SLP6) Index|The MOS Sleep Scale measures most constructs of sleep. The scale has a battery of questions to measure specific aspects of sleep in participants with co-morbidities. The SLP6 index is comprised of 6 items: provides a summary of sleep problems and contains questions from the sleep disturbance, sleep adequacy, respiratory impairment, and somnolence domains. The SLP6 index score ranges between 0 and 100, with higher values corresponding to more sleep problems.|Day 1 and Week 24 of initial treatment, before 1st retreatment, at 1st retreatment, and at 12 and 24 weeks after 1st retreatment|ITT population;n=number of participants assessed for the specified parameter at a given visit.||units on a scale||Standard Deviation|Mean
818448|NCT01126541|Secondary|SF-12 Mental Health Composite Score|Mental Health Composite Scores of SF-12 were computed using the scores of 12 questions and range from 0 to 100, where a 0 score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.|Day 1 and Week 24 of initial treatment, before 1st retreatment, at 1st retreatment, and at 12 and 24 weeks after 1st retreatment|ITT population; n=number of participants assessed for the specified parameter at a given visit.||units on a scale||Standard Deviation|Mean
818449|NCT01126541|Secondary|Short Form 12 (SF-12) Physical Health Composite Score|Physical and Mental Health Composite Scores of SF-12 were computed using the scores of 12 questions and range from 0 to 100, where a 0 score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.|Day 1 and Week 24 of initial treatment, before 1st retreatment, at 1st retreatment, and at 12 and 24 weeks after 1st retreatment|ITT population; n=number of participants assessed for the specified parameter at a given visit.||units on a scale||Standard Deviation|Mean
818450|NCT01126541|Secondary|HAQ-DI Scores|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0=least difficulty and 3 extreme difficulty.|Day 1 and Week 24 of initial treatment, before 1st retreatment, at 1st retreatment, and at 12 and 24 weeks after 1st retreatment|ITT population; n=number of participants assessed for the specified parameter at a given visit.||units on a scale||Standard Deviation|Mean
818451|NCT01126541|Secondary|Total Mean Dose of Cortisone Between Week 24 and Week 104|All cortisone intakes were taken into account, including oral, IV (including the cortisone administration before the rituximab infusion), intramuscular and intra-articular.|Week 24 to Week 104|ITT population||mg||Standard Deviation|Mean
818452|NCT01126541|Secondary|Cortisone Intake AUC (Time- and Weight-Weighted)|All cortisone intakes (in mg) were taken into account (oral, IV [including the cortisone administration before the rituximab infusion], intramuscular, and intra-articular).|Day 1 (each infusion), Week 24, Week 104|ITT population; n=number of participants assessed for the specified parameter at a given visit.||mg*week||Standard Error|Mean
818453|NCT01126541|Secondary|Participant Assessment of Fatigue|"Participants were asked to rate their level of fatigue over the last 7 days on a 100-mm VAS. The left-hand extreme of the line equals 0 mm, and is described as “no fatigue” and the right-hand extreme equals 100 mm as “extreme fatigue. Participants were asked to mark the line and the distance from the left edge was measured. Higher values correspond to worst state of participant (high levels of fatigue)."|Day 1 and Week 24 of initial treatment, before 1st retreatment, at 1st retreatment, and at 12 and 24 weeks after 1st retreatment|ITT population; n=number of participants assessed for the specified parameter at a given visit.||mm||Standard Deviation|Mean
818454|NCT01126541|Secondary|Patient's Global Assessment of Pain|"The participants assessed their pain over the past 24 hours on a 0 to 100 mm horizontal VAS. The left-hand extreme of the line equals 0 mm, and is described as “no pain” and the right-hand extreme equals 100 mm as “unbearable pain. Participants were asked to mark the line and the distance from the left edge was measured. Higher values correspond to worst state of participant (high pain levels)."|Day 1 and Week 24 of initial treatment, before 1st retreatment, at 1st retreatment, and at 12 and 24 weeks after 1st retreatment|ITT population; n=number of participants assessed for the specified parameter at a given visit.||mm||Standard Deviation|Mean
820250|NCT01142323|Primary|Serum Alkaline Phosphatase|Serum alkaline phosphatase will be measured at entry and end of study|6 months|||U/L||Standard Error|Median
818455|NCT01126541|Secondary|Patient Global Assessment of Disease Activity|The Patient's Global Assessment of Disease Activity is assessed on a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm as “maximum disease activity” (maximum arthritis disease activity). Higher values correspond to worst state of participant (high disease activity).|Day 1 and Week 24 of initial treatment, before 1st retreatment, at 1st retreatment, and at 12 and 24 weeks after 1st retreatment|ITT population; n=number of participants assessed for the specified parameter at a given visit.||mm||Standard Deviation|Mean
818456|NCT01126541|Secondary|Physician's Global Assessment of Disease Activity|The Physician’s Global Assessment of disease activity is assessed on a 0 to 100 millimeter (mm) horizontal VAS by the physician. The left-hand extreme of the line equals 0 mm, and is described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm as “maximum disease activity” (maximum arthritis disease activity). Physicians were asked to mark the line and the distance from the left edge was measured. Higher values correspond to worst state of participant (high disease activity).|Day 1 and Week 24 of initial treatment, before 1st retreatment, at 1st retreatment, and at 12 and 24 weeks after 1st retreatment|ITT population; n=number of participants assessed for the specified parameter at a given visit.||mm||Standard Deviation|Mean
818457|NCT01126541|Secondary|Percentage of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at 24 Weeks After Treatment|Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual’s own proteins) that are frequently detected in the blood of rheumatoid arthritis participants. Anti-CCP antibodies value higher than 10 U/mL is considered positive.|Week 24 of the initial treatment, 24 weeks after first re-treatment, and 24 weeks after second retreatment|ITT population; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
818458|NCT01126541|Secondary|Percentage of Participants With Rheumatoid Factor (RF) at 24 Weeks After Treatment|RF is the auto antibody directed against immunoglobulin G (IgG) and its concentration is observed in human serum or plasma. RF value higher than 20 international units per milliliter (IU/mL) is considered positive.|Week 24 of the initial treatment, 24 weeks after first re-treatment, and 24 weeks after second retreatment|ITT population; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
818459|NCT01126541|Secondary|Percentage of Participants Achieving a Response During Retreatment by EULAR Category|DAS28-based EULAR response criteria were used to measure individual response as no response, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders = change from baseline >1.2 with a DAS28 score of ≤3.2; moderate responders = change from baseline >1.2 with a DAS28 score of >3.2 to ≤ 5.1 or change from baseline >0.6 to ≤1.2 with a DAS28 score of ≤5.1; non-responders = change from baseline ≤0.6 or change from baseline >0.6 and ≤ 1.2 with a DAS28 score of >5.1.|Week 24, 24 weeks after 1st retreatment, 24 weeks after 2nd retreatment|ITT population; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
818460|NCT01126541|Secondary|Percentage of Participants Achieving a Response During Initial Treatment by European League Against Rheumatism (EULAR) Category|DAS28-based EULAR response criteria were used to measure individual response as no response, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders = change from baseline >1.2 with a DAS28 score of ≤3.2; moderate responders = change from baseline >1.2 with a DAS28 score of >3.2 to ≤ 5.1 or change from baseline >0.6 to ≤1.2 with a DAS28 score of ≤5.1; non-responders = change from baseline ≤0.6 or change from baseline >0.6 and ≤ 1.2 with a DAS28 score of >5.1.|Day 15, Weeks 6, 12, and 24|Overall population||percentage of participants|||Number
818461|NCT01126541|Secondary|Percentage of Participants Achieving American College of Rheumatology 20%, 50%, and 70% Improvement (ACR20/ACR50/ACR70)|ACR20/50/70 response defined as ≥20%, 50%, or 70% improvement, respectively, in TJC and SJC, and ≥20%, 50%, or 70% improvement, respectively, in at least 3 of 5 remaining ACR core measures: Patient Global Assessment of Pain, Patient's Global Assessment of Disease Activity, Physician's Global Assessment of Disease Activity (on a visual analog scale [VAS]); Health Assessment Questionnaire-Disability Index (HAQ-DI); and CRP.|Week 24 of the initial treatment, 24 weeks after first retreatment, and 24 weeks after second retreatment|ITT Population||percentage of participants|||Number
818462|NCT01126541|Secondary|Duration of DAS28-CRP ≤3.2 After Retreatment|DAS28-CRP was based on joint counts, overall participant assessment, and the serum CRP level at each visit. Joint counts included SJC and TJC using the 28 joints count and CRP (mg/L). Total score range=0 to 9.4; a higher score indicated more disease activity. A DAS28-CRP score of ≤3.2 implied low disease activity.|Days 1 and 15, Weeks 6, 12, and 24 and every 8 weeks thereafter through Week 104|ITT population; only participants with a response (DAS28-CRP ≤3.2) during retreatment (at any point) were included in the analysis. n=number of participants assessed at a given visit.||weeks||95% Confidence Interval|Median
818463|NCT01126541|Secondary|Duration of DAS28-CRP ≤3.2 After the First Course of Treatment|DAS28-CRP was based on joint counts, overall participant assessment, and the serum CRP level at each visit. Joint counts included SJC and TJC using the 28 joints count and CRP (mg/L). Total score range=0 to 9.4; a higher score indicated more disease activity. A DAS28-CRP score of ≤3.2 implied low disease activity.|Days 1 and 15, Weeks 6, 12, and 24 and every 8 weeks thereafter through Week 104|ITT population; only participants with a response (DAS28-CRP ≤3.2) during first course of treatment (at any point) were included in the analysis.||weeks||95% Confidence Interval|Median
818464|NCT01126541|Secondary|Duration of DAS28-CRP Remission After Retreatment|DAS28-CRP was based on joint counts, overall participant assessment, and the serum CRP level at each visit. Joint counts included SJC and TJC using the 28 joints count and CRP (mg/L). Total score range=0 to 9.4; a higher score indicated more disease activity. A DAS28-CRP <2.6=remission.|Days 1 and 15, Weeks 6, 12, and 24 and every 8 weeks thereafter through Week 104|ITT population; only participants with a response (DAS28-CRP <2.6) during retreatment (at any point) were included in the analysis. n=number of participants assessed at a given visit.||weeks||95% Confidence Interval|Median
818533|NCT01127165|Secondary|Change in Korean-Quality of Life Childhood Epilepsy (K-QOLCE)|The difference of K-QOLCE between before and after the administration. K-QOLCE is Korean version of the Quality of Life in Childhood Epilepsy Questionnaire. The calculated total score ranges 0-100, with higher scores indicating higher quality of life.|Baseline and 24 weeks|||Scores on a Scale||Standard Deviation|Mean
818465|NCT01126541|Secondary|Duration of DAS28-CRP Remission After the First Course of Treatment|DAS28-CRP was based on joint counts, overall participant assessment, and the serum CRP level at each visit. Joint counts included SJC and TJC using the 28 joints count and CRP (mg/L). Total score range=0 to 9.4; a higher score indicated more disease activity. A DAS28-CRP <2.6=remission.|Days 1 and 15, Weeks 6, 12, and 24 and every 8 weeks thereafter through Week 104|ITT population; only participants with a response (DAS28-CRP <2.6) during initial treatment (at any point) were included in the analysis.||weeks||95% Confidence Interval|Median
818466|NCT01126541|Secondary|Time to Achieve DAS28-CRP ≤3.2 After Retreatment|DAS28-CRP was based on joint counts, overall participant assessment, and the serum CRP level at each visit. Joint counts included SJC and TJC using the 28 joints count and CRP (mg/L). Total score range=0 to 9.4; a higher score indicated more disease activity. A DAS28-CRP score of ≤3.2 implied low disease activity.|Days 1 and 15, Weeks 6, 12, and 24 and every 8 weeks thereafter through Week 104|ITT population; n=number of participants assessed at a given visit.||weeks||95% Confidence Interval|Median
818467|NCT01126541|Secondary|Time to Achieve DAS28-CRP ≤3.2 After the First Course of Treatment|DAS28-CRP was based on joint counts, overall participant assessment, and the serum CRP level at each visit. Joint counts included SJC and TJC using the 28 joints count and CRP (mg/L). Total score range=0 to 9.4; a higher score indicated more disease activity. A DAS28-CRP score of ≤3.2 implied low disease activity.|Days 1 and 15, Weeks 6, 12, and 24 and every 8 weeks thereafter through Week 104|ITT population||weeks||95% Confidence Interval|Median
818468|NCT01126541|Secondary|Time to Achieve DAS28-CRP Remission After Retreatment|DAS28-CRP was based on joint counts, overall participant assessment, and the serum CRP level at each visit. Joint counts included SJC and TJC using the 28 joints count and CRP (mg/L). Total score range=0 to 9.4; a higher score indicated more disease activity. A DAS28-CRP <2.6=remission.|Days 1 and 15, Weeks 6, 12, and 24 and every 8 weeks thereafter through Week 104|ITT population; n=number of participants assessed at a given visit.||weeks||95% Confidence Interval|Median
818469|NCT01126541|Secondary|Time to Achieve DAS28-CRP Remission After the First Course|DAS28-CRP was based on joint counts, overall participant assessment, and the serum CRP level at each visit. Joint counts included SJC and TJC using the 28 joints count and CRP (mg/L). Total score range=0 to 9.4; a higher score indicated more disease activity. A DAS28-CRP <2.6=remission.|Days 1 and 15, Weeks 6, 12, and 24 and every 8 weeks thereafter through Week 104|ITT population||weeks||95% Confidence Interval|Median
818470|NCT01126541|Secondary|DAS28-CRP AUC Weighted Time|DAS28-CRP was based on joint counts, overall participant assessment, and the serum CRP level at each visit. Joint counts included SJC and TJC using the 28 joints count and CRP (mg/L). Total score range=0 to 9.4; a higher score indicated more disease activity. A DAS28-CRP score of ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity, and <2.6=remission.|Days 1 and 15, Weeks 6, 12, and 24 and every 8 weeks thereafter through Week 104|ITT population||units on a scale*week||Standard Deviation|Mean
818471|NCT01126541|Secondary|Percentage of Participants Achieving Clinical Remission (DAS28-CRP <2.6) or Low Disease Activity (DAS28-CRP ≤3.2)|Percentage of participants with clinical remission and low disease activity as measured by DAS28-CRP for Arm A and Arm B at Week 24 of the Initial Treatment, at 24 weeks after first re-treatment, and at 24 weeks after second retreatment. DAS28-CRP was based on joint counts, overall participant assessment, and the serum CRP level at each visit. Joint counts included SJC and TJC using the 28 joints count and CRP (mg/L). Total score range=0 to 9.4; a higher score indicated more disease activity. A DAS28-CRP score of ≤3.2 implied low disease activity and <2.6 = remission.|Week 24 of the Initial Treatment, 24 weeks after first retreatment, and 24 weeks after second retreatment|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
818472|NCT01126541|Primary|Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (DAS28-CRP) Area Under the Curve (AUC) at Week 104|DAS28-CRP was based on joint counts, overall participant assessment, and serum CRP levels (measured in milligrams per liter [mg/L]) at each visit. Joint counts included swollen joint count (SJC) and tender joint count (TJC). Total score range was 0 to 9.4; a higher score indicated more disease activity. DAS28-CRP less than or equal to (≤)3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity, and less than (<)2.6 equals (=) remission. The AUC of all DAS28-CRP values between Day 1 and Week 104 (15 values of protocol visits) was calculated using the trapeze method (AUC between t1 and t2=(t2-t1)*((DAS28-CRP at t1 + DAS28-CRP at t2)/2). The true visit dates were used to calculate the time between 2 DAS28-CRP evaluations. All the AUC were censored at Week 104 (linear extrapolation using the 2 last DAS28-CRP values (Weeks 96 and 104) to obtain the “true” DAS28-CRP value at the “true” Week 104).|Week 104|Per Protocol (PP) population: all randomized participants in the Intent-to-Treat (ITT) population (defined as all randomized participants) without major protocol violations. Participants were grouped according to their initially assigned treatment arm irrespective of the treatment actually received.||score on a scale*week||Standard Error|Mean
818473|NCT01126541|Secondary|DAS28-CRP and Changes From Baseline to Week 24 in DAS28-CRP by Retreatment Course|DAS28-CRP was based on joint counts, overall participant assessment, and the serum CRP level at each visit. Joint counts included SJC and TJC using the 28 joints count and CRP (mg/L). Total score range=0 to 9.4; a higher score indicated more disease activity. A DAS28-CRP score of ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity, and <2.6=remission.|Day 1, 24 weeks following each infusion up to 72 Weeks|ITT Population; number (n)=number of participants assessed for the specified parameter at a given visit.||units on a scale||Standard Deviation|Mean
818474|NCT01126541|Secondary|DAS28-CRP During the Initial Treatment|Mean DAS28-CRP at Week 24 of the Initial Treatment study. DAS28-CRP was based on joint counts, overall participant assessment, and the serum CRP level at each visit. Joint counts included SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity, and <2.6=remission.|Days 1 and 15, and Weeks 6, 12, and 24|Overall population: all participants with at least one treatment intake.||units on a scale||Standard Deviation|Mean
818534|NCT01127165|Secondary|Change in Behavior Assessment Korea-Child Behavior Checklist (K-CBCL)|The difference of K-CBCL between before and after the administration. K-CBCL is the Korean version of CBCL which is a standardized form that parents fill out to describe their children’s behavioral and emotional problems. The total score ranges 0- 234, with higher scores indicating worse behavioral and emotional problems.|Baseline and 24 weeks|||Scores on a Scale||Standard Deviation|Mean
818475|NCT01126580|Secondary|Measurement of LY2189265 Drug Concentration for Pharmacokinetics: Area Under the Concentration Curve (AUC)|Evaluable pharmacokinetic concentrations from the 4-week, 13-week, 26-week, and 52-week timepoints were combined and utilized in a population approach to determine the population mean estimate and standard deviation at steady-state.|4 weeks, 13 weeks, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 with evaluable LY2189265 concentration data.||nanogram hours per milliliter (ng*hr/mL)||Standard Deviation|Mean
818476|NCT01126580|Secondary|Number of Participants With Adjudicated Cardiovascular Events at 52 Weeks Plus 30-day Follow up|Information on cardiovascular (CV) risk factors was collected at baseline. Data on any new CV event was prospectively collected using a CV event electronic case report form. Deaths and nonfatal cardiovascular adverse events (AEs) were adjudicated by an external committee of physicians with cardiology expertise. Nonfatal cardiovascular AEs to be adjudicated included myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions, and cerebrovascular events, including cerebrovascular accident (stroke) and transient ischemic attack. The number of participants with CV events confirmed by adjudication is summarized cumulatively at 52 weeks plus 30-day follow up. Serious and all other non-serious adverse events regardless of causality are summarized in the Reported Adverse Events module.|Baseline through 52 weeks plus 30-day follow up|Participants who received at least one dose of LY2189265 or Metformin.||participants|||Number
818477|NCT01126580|Secondary|Number of Participants With Adjudicated Pancreatitis at 52 Weeks Plus 30-day Follow up|The number of participants with pancreatitis confirmed by adjudication is summarized cumulatively at 52 weeks plus 30-day follow up. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 52 weeks plus 30-day follow up|Participants who received at least one dose of LY2189265 or Metformin. Only pre-rescue measurements were used.||participants|||Number
818478|NCT01126580|Secondary|Rate of Self-reported Hypoglycemic Events at 52 Weeks|Hypoglycemic events were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of less than or equal to 70 milligrams per deciliter [mg/dL]), or asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of less than or equal to 70 mg/dL). The 1-year adjusted rate of hypoglycemic events is summarized cumulatively at 52 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 52 weeks|Participants who received at least one dose of LY2189265 or Metformin. Only pre-rescue measurements were used.||events per participant per year||Standard Deviation|Mean
818479|NCT01126580|Secondary|Number of Self-reported Hypoglycemic Events at 26 and 52 Weeks|Hypoglycemic events were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of less than or equal to 70 milligrams per deciliter [mg/dL]), or asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of less than or equal to 70 mg/dL). A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 weeks and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin. Only pre-rescue measurements were used.||events|||Number
818480|NCT01126580|Secondary|Number of Participants With Treatment Emergent Anti-LY2189265 Antibodies|A participant was considered to have treatment emergent LY2189265 anti-drug antibodies (ADA) if the participant had at least one titer that was treatment-emergent relative to baseline, defined as a 4-fold or greater increase in titer from baseline measurement. The total number of treatment emergent ADA was not analyzed at 26 weeks.|Baseline through 52 weeks|Participants who received at least one dose of LY2189265 with evaluable LY2189265 ADA data.||participants|||Number
818481|NCT01126580|Secondary|Change From Baseline to 26 and 52 Weeks in Serum Calcitonin||Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable serum calcitonin data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing||picograms per milliliter (pcg/mL)||Inter-Quartile Range|Median
818482|NCT01126580|Secondary|Change From Baseline to 26 and 52 Weeks in Pancreatic Enzymes|Amylase (total and pancreas-derived [PD]) and lipase concentrations were measured.|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable pancreatic enzyme data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||units per liter (U/L)||Inter-Quartile Range|Median
818483|NCT01126580|Secondary|Percentage Change From Baseline to 26 and 52 Weeks in Triglycerides|Percentage changes in triglycerides were assessed using analysis of variance (ANOVA) on the rank-transformed data with only treatment included in the model.|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable triglyceride data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing||percentage change in triglycerides||Inter-Quartile Range|Median
818484|NCT01126580|Secondary|Percentage Change From Baseline to 26 and 52 Weeks in Low Density Lipoprotein Cholesterol (LDL-C)|Percentage changes in LDL-C were assessed using analysis of variance (ANOVA) on the rank-transformed data with only treatment included in the model.|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable LDL-C data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing||percentage change in LDL-C||Inter-Quartile Range|Median
818485|NCT01126580|Secondary|Percentage Change From Baseline to 26 and 52 Weeks in High Density Lipoprotein Cholesterol (HDL-C)|Percentage changes in HDL-C were assessed using analysis of variance (ANOVA) on the rank-transformed data with only treatment included in the model.|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable HDL-C data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing||percentage change in HDL-C||Inter-Quartile Range|Median
818486|NCT01126580|Secondary|Percent Change From Baseline to 26 and 52 Weeks in Total Cholesterol|Percent changes in total cholesterol were assessed using analysis of variance (ANOVA) on the rank-transformed data with only treatment included in the model.|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable cholesterol data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||percentage change in total cholesterol||Inter-Quartile Range|Median
818487|NCT01126580|Secondary|Change From Baseline to 26 and 52 Weeks in Blood Pressure|Sitting systolic blood pressure (SBP) and sitting diastolic blood pressure (DBP) were measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, prior medication group, visit, and treatment-by-visit interaction as fixed effects, baseline interval as a covariate, and participant as a random effect.|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable blood pressure data.||milliliters of mercury (mmHg)||Standard Error|Least Squares Mean
818488|NCT01126580|Secondary|Change From Baseline to 26 and 52 Weeks in Pulse Rate|Sitting pulse rate was measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, prior medication group, visit, and treatment-by-visit interaction as fixed effects, baseline interval as a covariate, and participant as a random effect.|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable pulse rate data.||beats per minute (bpm)||Standard Error|Least Squares Mean
818489|NCT01126580|Secondary|Change From Baseline to 26 and 52 Weeks in Electrocardiogram Parameters, Heart Rate|Electrocardiogram (ECG) heart rate was measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, prior medication group, visit, and treatment-by-visit interaction as fixed effects and baseline interval as a covariate.|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable ECG heart rate data.||beats per minute (bpm)||Standard Error|Least Squares Mean
818490|NCT01126580|Secondary|Change From Baseline to 26 and 52 Weeks in Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. PR is the interval between the P wave and the QRS complex. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, prior medication group, visit, and treatment-by-visit interaction as fixed effects, baseline interval as a covariate, and participant as a random effect.|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable ECG QTcF interval or PR interval data.||milliseconds (msec)||Standard Error|Least Squares Mean
818491|NCT01126580|Secondary|Number of Participants With Treatment Emergent Adverse Events at 26 and 52 Weeks|A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with one or more TEAE is summarized cumulatively at 26 and 52 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|26 weeks and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin.||participants|||Number
818492|NCT01126580|Secondary|Change From Baseline to 26 and 52 Weeks in the Diabetes Symptoms Checklist Participant-reported Outcome (DSC-r) Score|The Diabetes Symptoms Checklist-revised (DSC-r) was designed to assess the presence and perceived burden of diabetes-related symptoms. Respondents were to consider troublesomeness of 34 symptoms on a 5-point scale ranging from 5=“extremely” to 1=“not at all.” For symptoms/side-effects not experienced, the item was scored as 0. Symptoms were grouped into the following subscales: psychology-fatigue, psychology-cognitive, neurology-pain, neurology-sensory, cardiology, ophthalmology, hypoglycemia, and hyperglycemia. Subscale scores were calculated as the sum of the given subscale divided by the total number of items in the scale. Total score was computed from the sum of the 8 subscales and ranged from 0 to 40. Higher scores indicate greater symptom burden. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, prior medication group, gender, and baseline score.|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable DSC-r data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||units on a scale||Standard Error|Least Squares Mean
818493|NCT01126580|Secondary|Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score, Change Version|The Diabetes Treatment Satisfaction Questionnaire change (DTSQc) score is used to assess relative change in participant satisfaction from baseline. The questionnaire consists of 8 items, 6 of which (1 and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale. The scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from -18 (much less satisfied) to +18 (much more satisfied). Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, prior medication group, gender, and baseline score.|52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable DTSQc data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) used to impute missing postbaseline values. If there were no data after randomization, endpoint was considered missing.||units on a scale||Standard Error|Least Squares Mean
818501|NCT01126580|Secondary|Change From Baseline to 26 and 52 Weeks in Fasting Blood Glucose|Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, prior medication group, visit, and treatment-by-visit interaction as fixed effects, baseline fasting blood glucose as a covariate, and participant as a random effect.|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable fasting blood glucose data. Only pre-rescue measurements were used.||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
820251|NCT01142336|Primary|Change From Baseline in CSF ptau181 at 1 Year|ptau 181 measured in CSF at baseline and after 1-year intervention|1-year change from baseline|||1-yr change (final - baseline), pg/ml||Standard Deviation|Mean
818494|NCT01126580|Secondary|Change From Baseline to 26 and 52 Weeks in the Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score, Status Version|The Diabetes Treatment Satisfaction Questionnaire status version (DTSQs) is used to assess participant treatment satisfaction at each study visit. The questionnaire consists of 8 items, 6 of which (1 and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale. Scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from 0 (very dissatisfied) to 36 (very satisfied). Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, prior medication group, gender, and baseline score.|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable DTSQs data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) used to impute missing postbaseline values. If there were no data after randomization, endpoint was considered missing.||units on a scale||Standard Error|Least Squares Mean
818495|NCT01126580|Secondary|Change From Baseline to 26 and 52 Weeks in the Impact of Weight on Self-Perception (IW-SP) Score|The Impact of Weight on Self-Perception (IW-SP) questionnaire contains 3 items that assess how often the participants' body weight affects how happy they are with their appearance and how often they feel self-conscious when out in public. Items are scored on a 5-point numeric rating scale where 5 = never and 1 = always. A single total score is calculated by summing the scores for all 3 items. Total score ranges between 3 and 15, where a higher score is indicative of better self-perception. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, prior medication group, gender, and baseline score.|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable IW-SP data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||units on a scale||Standard Error|Least Squares Mean
818496|NCT01126580|Secondary|Change From Baseline to 26 and 52 Weeks in the Impact of Weight on Activities of Daily Living (IW-ADL) Score|"The Impact of Weight on Activities of Daily Living (renamed the Ability to Perform Physical Activities of Daily Living [APPADL]) questionnaire contains 7 items that assess how difficult it is for participants to engage in certain activities considered to be integral to normal daily life, such as walking, standing and climbing stairs. Items are scored on a 5-point numeric rating scale where 5 = not at all difficult and 1 = unable to do. The individual scores from all 7 items are summed and a single total score is calculated and may range between 7 and 35. A higher score indicates better ability to perform activities of daily living. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, prior medication group, gender, and baseline score."|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable APPADL data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||units on a scale||Standard Error|Least Squares Mean
818497|NCT01126580|Secondary|Change From Baseline to 26 and 52 Weeks in Homeostasis Model Assessment of Beta-cell Function|The homeostatic model assessment (HOMA) quantifies insulin resistance and beta-cell function. HOMA2-B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady-state beta cell function (%B) as a percentage of a normal reference population (normal young adults). HOMA2-S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S) as percentages of a normal reference population (normal young adults). The normal reference populations were set at 100%. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, prior medication group, visit, and treatment-by-visit interaction as fixed effects, baseline HOMA2 as a covariate, and participant as a random effect.|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable HOMA2-%B or HOMA2-%S data. Only pre-rescue measurements were used.||percentage of HOMA2||Standard Error|Least Squares Mean
818498|NCT01126580|Secondary|Change From Baseline to 26 and 52 Weeks in Body Mass Index (BMI)|Body mass index is an estimate of body fat based on body weight divided by height squared. Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with country, treatment, and prior medication group as fixed effects and baseline BMI as a covariate.|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable BMI data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||kilograms per meter squared (kg/m^2)||Standard Error|Least Squares Mean
818499|NCT01126580|Secondary|Change From Baseline to 26 and 52 Weeks in Body Weight|Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with country, treatment, and prior medication group as fixed effects and baseline body weight as a covariate.|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable body weight data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||kilograms (kg)||Standard Error|Least Squares Mean
818500|NCT01126580|Secondary|Change From Baseline to 26 and 52 Weeks in Daily Mean Blood Glucose Values From the 8-point Self-monitored Blood Glucose (SMBG) Profiles|The SMBG data were collected at the following 8 time points: pre-morning meal; 2 hours post-morning meal; pre-midday meal; 2 hours post-midday meal; pre-evening; 2 hours post-evening meal; bedtime; and 3AM or 5 hours after bedtime. Least Squares (LS) means of the mean of the 8 time points (daily mean) were calculated using analysis of covariance (ANCOVA) with country, treatment, and prior medication group as fixed effects and baseline daily mean as a covariate.|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable SMBG data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
818532|NCT01127139|Primary|Compliance With Tarka Treatment, All Participants and by Gender.|Participants were asked how many doses of Tarka they had missed after three months of treatment.|Month 3 Visit|All participants with evaluable case report forms were analyzed.||participants|||Number
818502|NCT01126580|Secondary|Percentage of Participants Achieving a Glycosylated Hemoglobin (HbA1c) of Less Than 7% and Less Than or Equal to 6.5% at 26 and 52 Weeks|The percentage of participants achieving HbA1c level less than 7.0% and less than or equal to 6.5% was analyzed with a logistic regression model with baseline, prior medication group, and treatment as factors included in the model.|26 weeks and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable HbA1c data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||percentage of participants|||Number
818503|NCT01126580|Secondary|Change From Baseline to 52-week Endpoint in Glycosylated Hemoglobin (HbA1c)|Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with country, treatment, and prior medication group (previous oral antihyperglycemic medication [OAM] versus no previous OAM) as fixed effects and baseline HbA1c as a covariate.|Baseline, 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable HbA1c data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
818504|NCT01126580|Primary|Change From Baseline to 26-week Endpoint in Glycosylated Hemoglobin (HbA1c)|Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with country, treatment, and prior medication group (previous oral antihyperglycemic medication [OAM] versus no previous OAM) as fixed effects and baseline HbA1c as a covariate.|Baseline, 26 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable HbA1c data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
818505|NCT01126593|Primary|Pain Scores|Pain was measured via Visual Analong Scale in measurement (0-100mm).|O hour, 1, 2, 3, 4, 5, 6, 12 and 72 hours.|||mm||Standard Deviation|Mean
818506|NCT01126619|Secondary|Number of Participants With Adverse Events (AEs)|"The number of participants experiencing any adverse event or a serious adverse event during the study are summarized. A serious AE is an event that results in death, is life-threatening, requires or prolongs hospitalization, is a congenital anomaly, results in persistent or significant disability/incapacity or is an important medical event that may require medical or surgical intervention to prevent any of the outcomes listed above.
Please see the Adverse Event module below for additional details."|24 Weeks|All enrolled participants.||participants|||Number
818507|NCT01126619|Secondary|Percent Change From Baseline in Work Productivity and Activity Impairment|"The following parameters were assessed using the Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO):
Percent work time missed in the last 7 days due to problems associated with psoriasis;
Percent impairment at work, based on the participant's assessment of how much psoriasis affected their productivity while they were working in the last 7 days;
Percent overall loss of work productivity, based on hours missed and impairment while working due to psoriasis;
Percent general activity impairment, based on the participant's assessment of how much psoriasis affected their ability to perform regular daily activities, such as work around the house, shopping, child care, exercising, studying, etc.
Each domain score ranges from 0 (no impairment) to 100 (complete impairment). Change from Baseline is presented as a percentage of the Baseline value: Baseline value - post-baseline value / Baseline value * 100."|Baseline and Week 24|Participants who received treatment with anti-TNF agents and completed study follow-up visits through to Week 24. The first 3 domains (work time missed, work impairment and overall loss of work productivity) were assessed on a sub-group of participants who had full time jobs (n=30).||percent change||Full Range|Mean
818508|NCT01126619|Primary|Percentage of Participants With 75% Reduction in PASI Score|The percentage of participants with a 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI score is based on an assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and the percent area affected as observed on the day of examination. The score ranges from 0 (best outcome) to 72 (worst outcome).|Baseline and Weeks 4, 8, 16 and 24|Participants who received treatment with anti-TNF agents and completed study follow-up visits through to Week 24.||percentage of participants|||Number
818509|NCT01126619|Secondary|Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score|"The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all.
Change from Baseline is presented as a percentage of the Baseline value: Baseline value - post-baseline value / Baseline value * 100."|Baseline and Weeks 4, 8, 16 and 24|Participants who received treatment with anti-TNF agents and completed study follow-up visits through to Week 24.||percent change||Full Range|Mean
818510|NCT01126619|Secondary|Static Physician Global Assessment (PGA) of Psoriasis|"In the static physician assessment of psoriasis, psoriasis severity was rated first for all Baseline photographs and then for all Week 24 photographs according to the following scale:
Clear (no lesion); Psoriasis almost cleared; Mild psoriasis; Mild to moderate psoriasis; Moderate psoriasis; Moderate to severe psoriasis; Severe psoriasis."|Baseline and Week 24|Participants who received treatment with anti-TNF agents and completed study follow-up visits through to Week 24.||participants|||Number
818511|NCT01126619|Secondary|Dynamic Patient Global Assessment (PGA) of Change in Psoriasis|In the dynamic patient global assessment of change in psoriasis, the participant compared their own sets of standardized photographs taken at Baseline and at Week 24 and rated the change of the severity of psoriasis using the dynamic photographic scale adapted to a visual analog scale ranging from -5 (very large deterioration) to +5 (very large improvement).|Baseline and Week 24|Participants who received treatment with anti-TNF agents and completed study follow-up visits through to Week 24.||scores on a scale||Standard Deviation|Mean
818552|NCT01127581|Secondary|Incidence of Pre-delivery Oxytocin During the First Hospital Admission|Percentage of participants in receipt of Oxytocin for induction after study drug removal.|At least 30 minutes after study drug removal|Analysis population includes subjects who delivered during the first hospitalization.||percentage of participants||95% Confidence Interval|Number
818512|NCT01126619|Secondary|Dynamic Physician Global Assessment (PGA) of Change in Psoriasis|In the dynamic physician global assessment of change in psoriasis, the physician compared sets of standardized photographs taken at Baseline and at Week 24 for each participant and rated the change of psoriasis severity on the dynamic PGA scale from –5 (considerable deterioration), 0 (no or minimal change) to +5 (considerable improvement).|Baseline and Week 24|Participants who received treatment with anti-TNF agents and completed study follow-up visits through to Week 24.||scores on a scale||Standard Deviation|Mean
818513|NCT01126619|Primary|Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score|The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Change from Baseline is presented as a percentage of the Baseline value: Baseline value - post-baseline value / Baseline value * 100.|Baseline and Weeks 4, 8, 16 and 24|Participants who received treatment with anti-TNF agents and completed study follow-up visits through to Week 24.||Percent change||Standard Deviation|Mean
818514|NCT01126671|Secondary|Assessment of Bone Markers at Follow-up|After 11 weeks of vitamin D supplementation bone specific alkaline phosphatase, osteocalcin, and CTx will be repeated to see response to therapy.|12 weeks||||||
818515|NCT01126671|Secondary|Baseline Assessment of Bone Markers|Bone specific alkaline phosphatase, CTx, and osteocalcin will be assessed at baseline prior to subjects starting vitamin D supplementation|Baseline||||||
818516|NCT01126671|Primary|Follow-up 25OHD Levels|After 11weeks of treatment, repeat 25OHD levels will be drawn to assess subject response to vitamin D supplementation.|12 weeks|||ng/ml||Standard Deviation|Mean
818517|NCT01126671|Primary|Baseline 25OHD Levels|25OHD will be drawn at baseline prior to starting vitamin D supplementation.|Baseline|||ng/ml||Standard Deviation|Mean
818518|NCT01126723|Primary|Frailty Index|Frailty is defined as the combination of unintentional weight loss, exhaustion, low physical activity, slow walking speed, and muscular weakness.|post-intervention|per protocol||participants|||Number
818521|NCT01126957|Secondary|Satisfaction With Procedural Sedation|Score of 1 to 5 with 5 being completely satisfied and 1 being not satisfied at all was recorded by both the monitoring nurse and the physician performing the procedural sedation|20 minutes|103 participants completed the study. Data were collected but were not analyzed prior to the investigator leaving the institution, and neither did he make the data available for analysis.|||||
818522|NCT01126957|Primary|Respiratory Depression|"Endotracheal carbon dioxide (ETCO2) rise > 5mm/hg
Arterial oxygen saturation (SaO2) <90%
Respiratory rate (RR) < 8 br/min
Apnea > 15 sec
airway manipulation"|Baseline and throughout procedure|103 participants completed the study. Data were collected but were not analyzed prior to the investigator leaving the institution, and neither did he make the data available for analysis.|||||
818523|NCT01127087|Secondary|Total Urinary Oxalate Excretion|Oxalate is a salt of oxalic acid produced by the body's metabolism and excreted in the urine, measured in this study in two, 24-hour, urine collections.|Baseline, 4 weeks|||mg/24 hrs||Standard Deviation|Mean
818524|NCT01127087|Primary|Urinary Oxalate Creatinine Ratio|The urinary oxalate per creatinine ratio is expressed as mg/g. Paired t-test will be used when comparing reduction of urinary oxalate resulting from treatment (versus baseline) for each subject group.|Baseline, Week 4|||mg/g||Standard Deviation|Mean
818525|NCT01127139|Secondary|Adverse Events Leading to Study Discontinuation|The number of participants who discontinued from the study due to an adverse event and reported event descriptions are summarized.|Baseline to Month 6 Visit|All participants with case report forms were included in this analysis.||Participants|||Number
818526|NCT01127139|Secondary|Number and Type of Antihypertensive Drugs Added to Fixed Combination Tarka to Reach Blood Pressure Goal|The number of participants at the Month 6 visit who were taking other antihypertensive drugs in addition to their Tarka treatment to reach a blood pressure goal of less than 140/90 mmHg. The number of participants taking each type of additional drug is summarized.|Month 6 Visit|This analysis included all participants with complete data for the entire study.||Participants|||Number
818527|NCT01127139|Primary|Compliance With Tarka Treatment, All Participants and by Gender.|Participants were asked how many doses of Tarka they had missed since their previous visit.|Month 6 Visit|All participants with evaluable case report forms were analyzed.||participants|||Number
818528|NCT01127139|Secondary|Number and Type of Antihypertensive Drugs Added to Fixed Combination Tarka to Reach Blood Pressure Goal|The number of participants at the Month 3 visit who were taking other antihypertensive drugs in addition to their Tarka treatment to reach blood a pressure goal of less than 140/90 mmHg. The number of participants taking each type of additional drug is summarized.|Month 3 Visit|This analysis included all participants with complete data for the entire study.||Participants|||Number
818529|NCT01127139|Secondary|Percentage of Patients Achieving Blood Pressure < 140/90 mmHg|The percentage of patients who had achieved blood pressure less than 140/90 mmHg after six months of treatment.|Month 6 Visit|This analysis included all participants with complete data for the entire study.||Percentage of participants|||Number
818530|NCT01127139|Secondary|Percentage of Patients Achieving Blood Pressure < 140/90 mmHg|The percentage of patients who had achieved blood pressure less than 140/90 mmHg after three months of treatment.|Month 3 Visit|This analysis included all participants with complete data for the entire study.||Percentage of participants|||Number
818531|NCT01127139|Secondary|Change in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|The mean (average) change in participants' systolic blood pressure and diastolic blood pressure from the baseline visit to the Month 6 visit.|Baseline to Month 6 Visit|This analysis included all participants with complete data for the entire study.||mmHg||Standard Deviation|Mean
839184|NCT01324622|Primary|Number of Participants Without Surgical Intervention|Success defined as a lack of revision, removal or addition of supplemental fixation.|up to 24 months|||participants|||Number
818535|NCT01127165|Secondary|Change in Cognitive Assessment Korean-Wechsler Intelligence Scale for Children (K-WISC-Ⅲ)|Cognitive assessment was performed using K-WISC-III. The total score of K-WISC-III is calculated as Full Scale IQ which ranges from 31 (worst) to 151(best). Higher scores indicate greater intelligence, lower scores indicate less intelligence. Thus a positive change indicated an improvement.|Baseline and 24 weeks|||Scores on a Scale||Standard Deviation|Mean
818536|NCT01127165|Primary|Percentage of Participants Who Were Assessed As Seizure Free|The percentage of participants who showed no seizure during the maintenance phase.|24 weeks|||percentage of participants|||Number
818537|NCT01127256|Secondary|Quality of Life in Epilepsy (QoL-QOLIE31)|Quality of life assessment tool. Overall scores is calculated by summing subsections, and it ranges from 0 to 100. Higher score presents higher quality of life.|24 weeks|||Units On a Scale||Standard Deviation|Mean
818538|NCT01127256|Secondary|The Percentage of Participants With Retention Rate|The percentage of participants who completed the trial.|24 weeks|||percentage of participants|||Number
818539|NCT01127256|Primary|The Percentage of Participants With Seizure Free Rate|The percentage of participants who had no seizure during the trial.|24 weeks|||percentage of participants|||Number
818540|NCT01127321|Secondary|Number of Participants With Anti-Drug Antibodies to MEDI-570 at Any Visit||Predose on Day 1; Day 85, 113, and 169|Safety population included all participants who were randomized into the study and received at least 1 dose of investigational product.||participants|||Number
818541|NCT01127321|Secondary|Pharmacokinetic Parameters for MEDI-570|Following pharmacokinetic parameters were to be evaluated by using non-compartmental analysis: t1/2 = terminal phase elimination half-life which is the time measured for the serum concentration to decrease by one half; tmax = time to maximum observed serum concentration; Cmax = maximum observed serum concentration; AUC (0-t) = area under the serum concentration-time curve from time 0 to last measurable concentration; AUC (0-infinity) = area under the serum concentration-time curve from time 0 to extrapolated infinite time obtained from AUC (0-t) plus AUC (t-infinity); Vz/F = apparent volume of distribution, which is the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug; CL/F = apparent clearance which is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.|Predose and postdose on Day 1; Day 3, 5, 8, 15, 29, 57, 85, 113, 141, and 169|Due to early termination of the study, the results were reported as individual participant’s listings but not statistically summarized.|||||
818542|NCT01127321|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between administration of study drug and Day 169 that were absent before treatment or that worsened relative to pretreatment state.|Day 1 to Day 169|Safety population included all participants who were randomized into the study and received at least 1 dose of investigational product.||participants|||Number
818543|NCT01127438|Secondary|Number of Participants With Modified Sedation Success|Modified sedation success was defined as a subject who was a sedation success and did not have a MOAA/S score <2 any time after administration of sedative medication. Sedation success was defined as subjects who had 3 consecutive MOAA/S scores at or less than 4 after administration of sedative medication, completed the procedure, did not require the use of alternative sedative medication, and did not require manual/mechanical ventilation. The MOAA/S score was used to clinically rate the level of sedation using a score of 0 to 5 based on the level of responsiveness.|Day 1|Full Analysis Population.||Participants|||Number
818544|NCT01127438|Secondary|Number of Participants With Treatment Success|Treatment success was defined as subjects who met the following 3 criteria: completed the procedure, did not require the use of alternative sedative medication, and did not require manual/mechanical ventilation.|Day 1|Full Analysis Population.||Participants|||Number
818545|NCT01127438|Primary|Number of Participants With Sedation Success|Sedation success was defined as subjects who met the following 4 criteria: had 3 consecutive Modified Observer’s Assessment of Alertness/Sedation (MOAA/S) scores at or less than 4 after administration of sedative medication, completed the procedure, did not require the use of alternative sedative medication, and did not require manual/mechanical ventilation. The MOAA/S score was used to clinically rate the level of sedation using a score of 0 to 5 based on the subject’s level of responsiveness. A high score on the MOAA/S scale indicated a lower level of sedation.|Day 1|Full Analysis Population: All treated subjects who received study drug and had at least one postdose efficacy measurement.||Participants|||Number
818546|NCT01127581|Secondary|Rate of Adverse Events|All adverse events were rated by the Investigator as mild, moderate or severe and classified as having no relationship, possible relationship or a probable relationship to the study drug.|From study drug administration to hospital discharge (approximately 48-72 hours)|The percentage of subjects with adverse events are presented for the Intrapartum (before delivery), postpartum (maternal) and neonatal periods.||percentage of participants|||Number
818547|NCT01127581|Secondary|Incidence of Vaginal Delivery||Interval from study drug administration to vaginal delivery (average 24 hours)|The Intention-to-Treat (ITT) population was used for all secondary efficacy analyses.||percentage of participants||95% Confidence Interval|Number
818548|NCT01127581|Secondary|Incidence of Vaginal Delivery Within 24 Hours||Interval from study drug administration to vaginal delivery within 24 hours|Intention-to-Treat (ITT) Population||percentage of participants||95% Confidence Interval|Number
818549|NCT01127581|Secondary|Incidence of Any Delivery Within 12 Hours||Interval from study drug administration to delivery of neonate within 12 hours|Intention-to-Treat (ITT) Population||percentage of participants||95% Confidence Interval|Number
818550|NCT01127581|Secondary|Incidence of Any Delivery Within 24 Hours||Interval from study drug administration to delivery of neonate within 24 hours|Intention-to-Treat (ITT) Population||percentage of participants||95% Confidence Interval|Number
818551|NCT01127581|Secondary|Incidence of Vaginal Delivery Within 12 Hours||Interval from study drug administration to vaginal delivery within 12 hours|Intention-to-Treat (ITT) population||percentage of participants||95% Confidence Interval|Number
818553|NCT01127581|Secondary|Time to Active Labor During the First Hospital Admission|Active labor was defined as progressive cervical dilatation to 4 cm with any frequency of contractions OR rhythmic, firm, adequate quality uterine contractions causing progressive cervical change occurring at a frequency of 3 or more in 10 minutes and lasting 45 seconds or more.|Interval from study drug administration to active labor (average 12 hours)|Intention-to-Treat (ITT) population||minutes||95% Confidence Interval|Median
818554|NCT01127581|Secondary|Time to Any Delivery (Vaginal or Cesarean) During the First Hospital Admission||Interval from study drug administration to neonate delivery (average 24 hours)|Subjects who did not deliver during the first hospitalization were censored at the time of labour and delivery discharge.||minutes||95% Confidence Interval|Median
818555|NCT01127581|Primary|Incidence of Cesarean Delivery During the First Hospital Admission||Interval from study drug administration to cesarean delivery (average 24 hours)|Analysis was based on a between-treatment-group difference in the safety population. Subjects discharged prior to delivery, withdrew early without having a cesarean delivery or were lost-to-follow up were classified as not having the event.||percentage of participants||95% Confidence Interval|Number
818556|NCT01127581|Primary|Time to Vaginal Delivery During the First Hospital Admission||Interval from study drug administration to vaginal delivery (average 24 hours)|Subjects who underwent a cesarean delivery during the first hospitalization were censored using the longest time interval from study drug administration to cesarean delivery, independent of treatment assignment. Subjects who were discharged prior to delivery or withdrew consent prior to delivery were also censored.||minutes||95% Confidence Interval|Median
818557|NCT01127607|Secondary|Adult ADHD Rating Scale Completed at the End of the Med Optimization Phase|Measures change in all DSM IV ADHD symptoms on a 0 (least severe) to 3 (most severe) scale. All information obtained during clinician interview of patient. Inattention and hyperactive/impulsive subscales each consist of 9 items with range of 0 to 27. Total Score consists of all 18 items (sum of two subscales) rated 0 to 3 with range of 0 to 54. For all, higher scores indicate more symptoms.|baseline and end of med optimization phase/week 4|Uses a within-subjects design; the same 27 participants are in both arms.||scores on a scale||Standard Deviation|Mean
818558|NCT01127607|Secondary|Pittsburgh Side Effects Rating Scale - Percent Present for All Reported Adverse Events Occurring at a Rate of 5% or More|Self report of side effects measured during dose titration using the Pittsburgh Side Effects Rating Scale. Consists of 13 items each rated using 0(none) to 3 (severe) scales. Items endorsed as 1 (mild) or above were counted as present. Information on additional adverse events not part of the PSERS was collected by direct interview of the participants. All side effects occurring at a frequency of 5% or more are reported. Initial side effect data is reported for all participants entering pre-randomization med optimization phase who took medication (n=36) vs those formally enrolled (N=27). Also, side effect data for the med titration phase is entered per dose rather than per participant. For example, a person trying the 30, 50 and 70mg dose is entered is entered 4 times (no med as well) vs. just once. This is why baseline N is higher than for other outcomes collected at weeks 4 and 8 where data was only available for those completing the pre-randomization med optimization phase (N=27).|end of medication optimization phase/week 4|Within-subjects analysis; data entered per dose not per subject. For example, if subject 1 took 30mg, 50mg and 70mgdoses during titration, they are recorded as three separate entries. Sample size reduces as dose increases because participants stopped at lowest acceptable dose and only moved to higher dose if they did not meet optimization criteria.||Percent of participants|||Number
818559|NCT01127607|Secondary|Resting Pulse|measured at last assessment visit when at rest using an automated blood pressure machine; results reported in beats per minute. At endpoint, the medication group (N=8) was compared to the placebo group (N=9).|study endpoint- end of period II (between subjects trial)|||bpm||Standard Deviation|Mean
818560|NCT01127607|Primary|Dyadic Parent-Child Interaction Coding System (DPICS) - Behavior Percentages|Observations of parents and children as they interact with each other during a five minute homework task and during a 10 minute non-academic task. Interactions were recorded and later coded by trained observers. Observers counted number of parent and child behaviors. Percentages of behaviors as a function of total verbalizations (for praise, negative talk, demanding) or as a function of commands and questions (for impatient and responsive) were computed.Three subjects dropped prior to completing this assessment and one participant completed the other endpoint measures but not the DPICS, which is why the total N for this outcome is 23 at study endpoint. At end of period II (study endpoint), the medication group (n=10) was compared to the placebo group (N=13).|study endpoint- end of period II (between subjects trial)|Task situation (homework vs. non-academic) was within-subjects; all participants completed both types of interactions. Medication was between subjects.||Percentage of behaviors||Standard Deviation|Mean
818561|NCT01127607|Primary|Dyadic Parent-Child Interaction Coding System (DPICS) - Behavior Counts|Observations of parents and children as they interact with each other during a five minute homework task and during a 10 minute non-academic task. Interactions were recorded and later coded by trained observers. Observers counted number of parent and child behaviors. Average number of behaviors per group were computed. Three subjects dropped prior to completing this assessment and one participant completed the other endpoint measures but not the DPICS, which is why the total N for this outcome is 23 at study endpoint. At end of period II (study endpoint), the medication group (n=10) was compared to the placebo group (N=13).|study endpoint- end of period II (between subjects trial)|Task situation (homework vs. non-academic) was within-subjects; all participants completed both types of interactions. Medication was between subjects.||behaviors||Standard Deviation|Mean
818562|NCT01127607|Secondary|Weight|Weight measured on calibrated scale; participant measured without shoes or heavy clothing (jackets, sweaters, etc...). reported in kilograms.At endpoint, the medication group (N=9) was compared to the placebo group (N=11).|study endpoint- end of period II (between subjects trial)|||kg||Standard Deviation|Mean
818563|NCT01127607|Secondary|Impairment Rating Scale (IRS)|self rated measure of global impairment of adult participants derived from the child IRS. The IRS-A assesses impairment overall and in specific domains, including interpersonal relationships, academic performance, and self-esteem, and includes adult-specific domains of functioning, such as employment and romantic relationships. The IRS-A assesses current problems and need for treatment. Each subscale is rated from 0 (no problem) to 6 (extreme problem).At endpoint, the medication group (N=11) was compared to the placebo group (N=13). Overall Impairment is its own subscale and not a composite score of the others.|study endpoint- end of period II (between subjects trial)|||units on a scale||Standard Deviation|Mean
818564|NCT01127607|Secondary|Alabama Parenting Questionnaire (APQ)|"measures change in parenting practices.The APQ is a 42-item measure (each item ranges from 1/always to 5/never) on which parents are asked to indicate the frequency with which they implement the following parenting practices: involvement (10 items range 10-50- higher scores mean more parental involvement), positive parenting (6 items with range of 6 to 30 and higher scores indicate greater use of praise), poor monitoring/supervision (10 items with range of 10 to 50 and higher scores indicate less supervision/monitoring), inconsistent discipline(6 items with range of 6 to 30 and higher scores indicate greater problems with inconsistent discipline), and corporal punishment (3 items with range of 3-15 and greater scores indicate more use of corporal punishment). Items are rated on a 5-point scale, ranging from 1 (“never”) to 5 (“always”). Items summed into composite scales.
At endpoint, the medication group (N=9) was compared to the placebo group (N=13)."|study endpoint- end of period II (between subjects trial)|||units on a scale||Standard Deviation|Mean
818565|NCT01127607|Secondary|Resting Blood Pressure|Measured at rest at last assessment visit using an automated blood pressure machine; results reported in mmHG. At endpoint, the medication group (N=9) was compared to the placebo group (N=10).|study endpoint- end of period II (between subjects trial)|||mm Hg||Standard Deviation|Mean
818566|NCT01127607|Secondary|Pittsburgh Side Effect Rating Scale Mean Severity Rating.|rates 13 potential adverse events of Central Nervous System (CNS) stimulants on a 0-3 likert scale with 0=none 1=mild severity, 2=moderate severity, 3=severe severity. Form completed by participants. Mean severity rating then averaged across 13 categories.At endpoint, the medication group (N=10) was compared to the placebo group (N=13).|study endpoint- end of period II (between subjects trial)|||units on a scale||Standard Deviation|Mean
818567|NCT01127607|Secondary|Barkley Home Situations Questionnaire (HSQ)|Self completed by adult participants. Measures their child's functioning in the evening by asking them to report whether or not their child had problems in developmentally important areas. Number of problems per child are counted and counts are then averaged for each group with higher numbers representing more problems. At endpoint, the medication group (N=9) was compared to the placebo group (N=10).|study endpoint- end of period II (between subjects trial)|||number of child problems endorsed||Standard Deviation|Mean
818568|NCT01127607|Secondary|ADHD Severity Clinical Global Impressions Severity Subscale|clinician rated measure of ADHD symptom severity in adult participants. The severity subscale is scored from 1 (normal) to 7 (extremely ill).At endpoint, the medication group (N=10) was compared to the placebo group (N=13).|study endpoint- end of period II (between subjects trial)|||units on a scale||Standard Deviation|Mean
818569|NCT01127607|Secondary|Sheehan Disability Scale (SDS)|The SDS consists of 3 self rated items assessing the degree to which symptoms affect work/school, social life, and family/home responsibilities. Items are rated on a 0 (not at all) to 10 (extremely) scale. Items were averaged into an overall disability score with range of 0 to 10 with higher scores indicating more severe disability. At endpoint, the medication group (N=9) was compared to the placebo group (N=13).|study endpoint- end of period II (between subjects trial)|||units on a scale||Standard Deviation|Mean
818570|NCT01127607|Secondary|Impairment Rating Scale (IRS)|measures global functioning of child rated by the parent who was the participant in the study. The IRS is a 7 item measure that uses visual-analogue scales to evaluate the child’s problem level and need for treatment in developmentally important areas, such as peer relationships, adult-child relationships, academic performance. Each subscale including overall severity is scored from 0 (no problem) to 6 (extreme problem) with higher scores indicating more impairment. At endpoint, the medication group (N=10) was compared to the placebo group (N=13).|study endpoint- end of period II (between subjects trial)|||units on a scale||Standard Deviation|Mean
818571|NCT01127607|Secondary|Disruptive Behavior Disorder Rating Scale (DBD)|measures externalizing symptoms in children.measures externalizing symptoms in children completed by their primary caretaker who was a participant in the study. The DBD (Pelham et al., 1992) assessed DSM symptoms of ADHD, ODD, and CD from 0 (not at all) to 3 (very much). The DBD includes symptoms of DSM-III and DSM-IV ADHD, Oppositional Defiant Disorder (ODD) and Conduct Disorder (CD).At endpoint, the medication group (N=10) was compared to the placebo group (N=12).|study endpoint- end of period II (between subjects trial)|||units on a scale||Standard Deviation|Mean
818572|NCT01127607|Secondary|Social Skills Rating System (SSRS)|"Measures child's interactions with peers and adults. Items rated using Likert scales that range from 0 (never) to 2 (often).At week 8, the medication group (N=10) was compared to the placebo group (N=11). There are two subscales: Problem Behaviors (18 items rated between 0-2 for total score range of 0 to 36) and Social Skills (40 items rated 0-2 with range for total score of 0-80). The total scores for these scales are reported as standard scores, with a population mean of 100 and standard deviation of 15. For problem behavior higher scores indicate worse behavior whereas for social skills, higher scores indicate more social (or better behavior)."|study endpoint- end of period II (between subjects trial)|||standard scores||Standard Deviation|Mean
818573|NCT01127607|Secondary|Brown Attention Deficit Scale (BAADS)|"Measures executive functioning using 40 items each rated using a Likert Scale that ranges from 0 (never) to 3 (almost daily). Activation, Attention and effort subscales are 9 items each with range of 0-27. Affect scale is 7 items (range 0-21), memory is 6 items (range 0-18) and total score is 40 items (range 0-120). All raw scores are then reported as T scores based on normative data with higher T scores indicating worse executive functioning. At endpoint, the medication group (N=10) was compared to the placebo group (N=13)."|study endpoint- end of period II (between subjects trial)|||t score||Standard Deviation|Mean
818574|NCT01127607|Secondary|Parenting Locus of Control (PLC)|"self completed parenting measure of the degree to which parents feel they can influence their child’s behavior. Measure consists of 25 items each rated using a Likert scales that ranges from 1 (strongly disagree) to 5 (strongly agree). Range is 25 to 125 with higher scores indicating greater parental control over their child's behavior (desired outcome). At endpoint, the medication group (N=9) was compared to the placebo group (N=13)."|study endpoint- end of period II (between subjects trial)|||units on a scale||Standard Deviation|Mean
818608|NCT01128114|Secondary|The CGI-I (Clinical Global Impression-Improvement of Illness) Change From Baseline to Week 4|The Global Improvement scale (CGI-I) is scored to rate the patient’s change from baseline CGI. A CGI-I score of 1 indicates that a patient is “very much improved” and a score of 7 indicates that a patient is “very much worse.” CGI-I scores greater than 4 indicate worsening, while scores less than 4 indicate improvement. At all following visits CGI-I will also be rated. The following calculations will be made: Proportion of patients with CGI Global Improvement rating ≤ 2 at Day 29|Baseline, week 4||||||
818575|NCT01127607|Secondary|Parenting Stress Index (PSI)--Total Stress|measures change in stress of parent child interactions and completed by the participant. The PSI is a measure of the source and degree of parenting stress (Abidin, 1995), which contains 120 items which are rated on a 1 (strongly disagree) to 5 (strongly agree) scale. 101 of these items are used to compute a total stress score (reported below) as the other 19 report on specific life stressors. Range is 101 to 505, for which higher scores indicate higher levels of stress. At endpoint, the medication group (N=9) was compared to the placebo group (N=13).|study endpoint- end of period II (between subjects trial)|||units on a scale||Standard Deviation|Mean
818576|NCT01127607|Secondary|Adult ADHD Rating Scale (ADHD RS)|measures change in all DSM (Diagnostic and Statistics Manual) IV ADHD symptoms on a 0 (least severe) to 3 (most severe) scale. Inattention and hyperactive/impulsive subscales each consist of 9 items with range of 0 to 27. Total Score consists of all 18 items rated 0 to 3 with range of 0 to 54. For all, higher scores indicate more symptoms. All information obtained during clinician interview of patient. At endpoint, the medication group (N=11) was compared to the placebo group (N=13).|study endpoint- end of period II (between subjects trial)|||units on a scale||Standard Deviation|Mean
818577|NCT01127607|Secondary|Pittsburgh Side Effect Rating Scale|rates 13 potential adverse events of central nervous system stimulant medications on a 0-3 likert scale with 0=none 1=mild severity, 2=moderate severity, 3=severe severity. Form completed by participants at end of med optimization phase. Mean severity rating then averaged across 13 categories. This compares mean side effect severity at unmedicated baseline state vs. on optimal dose at week 3. Analysis includes all participants completing medication optimization.|baseline and end of dose optimization phase/week 4|Within-subjects analysis; same 26 participants are in the unmedicated and optimal dose of medication arms.||units on a scale||Standard Deviation|Mean
818578|NCT01127607|Secondary|Dyadic Parent-Child Interaction Coding System (DPICS) - Behavior Percentages|Observations of parents and children as they interact with each other during a five minute homework task and during a 10 minute non-academic task. Interactions were recorded and later coded by trained observers. Observers counted number of parent and child behaviors with each parent-child dyad counted as one participant. Percentages of behaviors as a function of total verbalizations (for praise, negative talk, demanding) or as a function of commands and questions (for impatient and responsive) were computed. This outcome was part of period I- the within subject comparison of all participating subjects once on placebo (n=26) and once with all subjects on active medication (N=26). (the 27th participant completed this phase but partial data was lost due to mechanical failure with video equipment so their data was not included). All adult participants received both placebo and active medication in this phase that comprised all of period 1.|weeks 4 and weeks 5 (period I within subjects trial)|Used a within-subjects design; the same 26 participants completed all arms.||Percentage of behaviors||Standard Deviation|Mean
818579|NCT01127607|Secondary|Dyadic Parent-Child Interaction Coding System (DPICS)|Observations of parents and children as they interact with each other during a five minute homework task and during a 10 minute non-academic task. Interactions were recorded and later coded by trained observers. Observers counted number of parent and child behaviors with each parent-child dyad counted as one participant. Average number of behaviors per group were computed.This outcome was part of period I- the within subject comparison of all participating subjects once on placebo (n=26) and once with all subjects on active medication (N=26). (the 27th participant completed this phase but partial data was lost due to mechanical failure with video equipment so their data was not included). All adult participants received both placebo and active medication in this phase that comprised all of period 1.|weeks 4 and weeks 5 (period I within subjects trial)|Used a within-subjects design for this phase; the same 26 participants completed all four arms.||behaviors||Standard Deviation|Mean
818580|NCT01127607|Secondary|Sheehan Disability Scale (SDS)|The SDS consists of 3 self rated items assessing the degree to which symptoms affect work/school, social life, and family/home responsibilities. Items are rated on a 0 (not at all) to 10 (extremely) scale. Items were averaged into an overall disability score with range of 0 to 10 with higher scores indicating more severe disability.Within subject comparison of no medication baseline vs. optimal dose medication.|baseline and week 4|Uses a within-subjects design; the same 25 participants are in both arms.||units on a 0 to 10 scale||Standard Deviation|Mean
818581|NCT01127607|Secondary|Impairment Rating Scale (IRS)|"Parent ratings of their child's functioning and need for treatment in developmentally important domains. Ratings are completed using visual-analogue scales that are anchored at the low end by no problems / no need for treatment and at the high end by extreme problem / definitely needs treatment. Visual analogue ratings for each subscale were converted to 0 to 6 scales with higher values indicating greater impairment and lower values indicating less impairment for each subscale.Within subject comparison of no medication baseline vs. optimal dose medication."|baseline and week 4|Uses a within-subjects evaluation; the same 25 participants are in both arms.||units on a 0 to 6 scale||Standard Deviation|Mean
818582|NCT01127607|Secondary|Disruptive Behavior Disorders Rating Scale (DBD)|Parent ratings of their child's symptoms of attention-deficit hyperactivity disorder (ADHD), oppositional defiant disorder (ODD), and conduct disorder (CD). Measure consists of 45 items each rated on a Likert scale that ranges from 0 (not at all) to 3 (very much). Items are averaged to form adhd-inattention, adhd-hyperactive/impulsive, ODD, and CD scores.Within subject comparison of no medication baseline vs. optimal dose medication. ADHD subscale consists of 20 items with range of 0 to 60. ODD subscale consists of 9 items with range of 0 to 27. CD subscale consists of 15 items with range of 0 to 45. For all subscales, higher scores indicate more severe symptoms.|baseline and week 4|Used a within-subjects design; the same 24 participants measured in both arms.||units on a scale||Standard Deviation|Mean
818593|NCT01127646|Secondary|Attention-Deficit/Hyperactivity Disorder Rating Scale-Parent Version: Investigator Administered and Scored (ADHD-RS-IV Parent:Inv) Total Score and Subscores at Weeks 2, 3, and 4|Assesses 18 Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) ADHD diagnosis symptoms/severity in past week. Each item: 0 (none/never, rarely) to 3 (severe/very often). Total score ranges from 0 to 54. Higher total scores indicate greater illness severity. This outcome measure was not analyzed due to the insufficient sample size.|Weeks 2, 3, and 4|No participants had data analyzed due to the termination of the trial and the insufficient sample size.|||||
818627|NCT01128192|Primary|Change in Low Dose % Endogenous Glucose Production (EGP) Inhibition|Change from Day 3 and Day 10 of low dose % EGP Inhibition (Hyperinsulinemic-Euglycemic Clamp)|Day 3 and Day 10|||percentage of EGP Inhibition||Standard Deviation|Mean
818583|NCT01127607|Secondary|Alabama Parenting Questionnaire (APQ)|"measures change in parenting practices.The APQ is a 42-item measure (each item ranges from 1/always to 5/never) on which parents are asked to indicate the frequency with which they implement the following parenting practices: involvement (10 items range 10-50- higher scores mean more parental involvement), positive parenting (6 items with range of 6 to 30 and higher scores indicate greater use of praise), poor monitoring/supervision (10 items with range of 10 to 50 and higher scores indicate less supervision/monitoring), inconsistent discipline(6 items with range of 6 to 30 and higher scores indicate greater problems with inconsistent discipline), and corporal punishment (3 items with range of 3-15 and greater scores indicate more use of corporal punishment). Items are rated on a 5-point scale, ranging from 1 (“never”) to 5 (“always”). Items summed into composite scales.
Within subject comparison of no medication baseline vs. optimal dose medication."|baseline and week 4|Used a within-subjects evaluation; the same 24 participants evaluated in both arms.||units on a scale||Standard Deviation|Mean
818584|NCT01127646|Other Pre-specified|Change From Baseline in Systolic and Diastolic Blood Pressure up to 5 Weeks||Baseline, up to 5 weeks|Safety population: all participants who entered the study and took at least 1 dose of study medication.||millimeters of mercury (mm Hg)||Standard Deviation|Mean
818585|NCT01127646|Other Pre-specified|Change From Baseline in Heart Rate up to 5 Weeks||Baseline, up to 5 weeks|Safety population: all participants who entered the study and took at least 1 dose of study medication.||beats per minute (bpm)||Standard Deviation|Mean
818586|NCT01127646|Secondary|Global Impression of Perceived Difficulties Investigator Version (GIPD-Inv) Total Score and Subscores At Weeks 2, 3, and 4|Assesses attention-deficit/hyperactivity disorder (ADHD)-related difficulties (overall difficulties perceived in morning, during school, during homework, in evening, and over entire day and night). Difficulties during past week are rated by investigator on a 7-point scale (1=normal, not difficult at all; 7=extremely difficult) for each of 5 items. Total score=sum of all subscores (items) and ranges from 5 to 35. Higher scores indicate greater impairment. This outcome measure was not analyzed due to the insufficient sample size.|Weeks 2, 3, and 4|No participants had data analyzed due to the termination of the trial and the insufficient sample size.|||||
818587|NCT01127646|Secondary|Conners' Global Index-Teacher Rating Scale Total Score During the 4-Week Treatment Period|The teacher version of Conners' Global Index consists of 10 items with each item being scored on a 4-point scale ranging from 0 (not true at all, or never/seldom) to 3 (very much true, or very often/very frequent). The total score ranges from 0 to 30. Higher scores indicate greater impairment. The Conners’ Global Index-Teacher Rating Scale total score for days with missing doses (off-days) between both groups were not analyzed due to insufficient sample size.|Baseline through 4 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.|||||
818588|NCT01127646|Secondary|Daily Parent Report of Evening and Morning Behavior-Revised (DPREMB-R) Scale Total Score and Subscores During the 4-Week Treatment Period|Parent-completed 11-item questionnaire; measures difficulty level of 3 common morning behaviors (such as, get out of bed) and 8 common evening behaviors (such as, sit through dinner) from 0 (no difficulty) to 3 (a lot of difficulty). Evening behavior total score range is 0 to 24. Morning behavior total score range is 0 to 9. Total score (evening+morning) range is 0 to 33. Higher scores indicate greater difficulty in evening and morning behavior. Mean DPREMB-R total score and subscores for days with missing doses (off-days) between both groups were not analyzed due to insufficient sample size.|Baseline through 4 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.|||||
818589|NCT01127646|Secondary|Patient Outcomes Questions (On-Days Versus Off-Days) During the 4-Week Treatment Period|"6-item questionnaire from attention-deficit/hyperactivity disorder (ADHD) advocacy group evaluates treatment outcomes ADHD participant's perspective. Parent completed on each day of on/off period. Each item ranged from 1 (I totally agree) to 5 (I totally disagree). Items 1 and 2 pertain to sleeping and eating; high scores=better outcome. Items 3-6 pertain to behavior; high scores=worse outcome. The mean scores for analysis would have been created for each question across the days of each of the on and off phases; however, mean scores were not analyzed due to insufficient sample size."|Baseline through 4 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.|||||
818590|NCT01127646|Secondary|Daily Parent Report of Evening and Morning Behavior-Revised (DPREMB-R) Scale Subscores (On-Days Versus Off-Days) During the 4-Week Treatment Period|Parent-completed 11-item questionnaire; measures difficulty level of 8 common evening behaviors (such as, sit through dinner) and 3 common morning behaviors (such as, get out of bed) from 0 (no difficulty) to 3 (a lot of difficulty). Evening behavior total score range is 0 to 24. Morning behavior total score range is 0 to 9. Higher scores indicate greater difficulty in evening and morning behavior. DPREMB-R subscores between days without missing doses (on-days) and days with missing doses (off-days) not analyzed due to insufficient sample size.|Baseline through 4 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.|||||
818591|NCT01127646|Secondary|Emotion Expression Scale for Children (EESC)-Parent Rated Total Score up to Week 5|"29-item parent-reported measure used to monitor effect of attention-deficit/hyperactivity disorder (ADHD) medication; examines 3 aspects of emotion expression: positive emotions, emotional flatness, and emotional lability. Each item rated on 5-point Likert scale (1=not at all true to 5=very much true). Positive emotional subscale items reversed scored (6-raw score). Total score=transformed positive emotion + emotional flatness+ emotional lability subscales. Total scores range: 29 to 145. Higher scores=emotional impairment. This outcome measure not analyzed due to insufficient sample size."|Up to Week 5|No participants had data analyzed due to the termination of the trial and the insufficient sample size.|||||
818592|NCT01127646|Secondary|Clinical Global Impression-Attention Deficit/Hyperactivity Disorder-Severity Scale (CGI-ADHD-S) at Weeks 2, 3, and 4|This instrument is a single-item expert rating of the severity of the participant’s attention-deficit/hyperactivity disorder (ADHD) symptoms in relation to the assessor’s total experience of participants with ADHD. Severity is rated on a 7-point scale (1=normal, not ill at all; 7=among the most extremely ill participants). Higher scores represent greater illness severity. This outcome measure was not analyzed due to the insufficient sample size.|Weeks 2, 3, and 4|No participants had data analyzed due to the termination of the trial and the insufficient sample size.|||||
818628|NCT01128192|Primary|Change in Basal Endogenous Glucose Production (EGP)|Change from Day 3 and Day 10 of Basal EGP (Hyperinsulinemic-Euglycemic Clamp)|Day 3 and Day 10|||mg/kg/min||Standard Deviation|Mean
818594|NCT01127646|Secondary|Global Impression of Perceived Difficulties Scale-Patient Version (GIPD-Pat) Scale Total Score and Individual Items During the 4-Week Treatment Period|Assesses attention-deficit/hyperactivity disorder (ADHD)-related difficulties (overall difficulties perceived in morning, during school, during homework, in evening, over entire day and night). Difficulties during past week are rated by participant on a 7-point scale (1=normal, not difficult at all; 7=extremely difficult) for each of 5 items. Total score=sum of all subscores (items); range: 5 to 35. Higher scores=greater impairment. Mean GIPD-Pat total score and individual item scores for days with missing doses (off-days) between both groups were not analyzed due to insufficient sample size.|Baseline through 4 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.|||||
818595|NCT01127646|Secondary|Conners' Global Index-Teacher Rating Scale Total Score (On-Days Versus Off-Days) During the 4-Week Treatment Period|The teacher version of Conners’ Global Index consists of 10 items with each item being scored on a 4-point scale ranging from 0 (not true at all, or never/seldom) to 3 (very much true, or very often/very frequent). The total score ranges from 0 to 30. Higher scores indicate greater impairment. The Conner’s Global Index-Teacher Rating Scale total score between days without missing doses (on-days) and days with missing doses (off-days) was not analyzed due to the insufficient sample size.|Baseline through 4 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.|||||
818596|NCT01127646|Secondary|Global Impression of Perceived Difficulties (GIPD) Scale-Patient Version Total Score and Individual Items (On-Days Versus Off-Days) During the 4-Week Treatment Period|Assesses attention-deficit/hyperactivity disorder (ADHD)-related difficulties (overall difficulties perceived in morning, during school, during homework, in evening, over entire day and night). Participant rates difficulties during past week on 7-point scale (1=normal, not difficult at all; 7=extremely difficult) for each of 5 items. Total score=sum of all subscores (items); range: 5 to 35. Higher scores=greater impairment. GIPD-Pat total score and item scores between days without missing doses (on-days) and days with missing doses (off-days) were not analyzed due to insufficient sample size.|Baseline through 4 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.|||||
818597|NCT01127646|Primary|Daily Parent Report of Evening and Morning Behavior-Revised (DPREMB-R) Scale Mean Total Score (On-Days Versus Off-Days) During the 4-Week Treatment Period|Parent-completed 11-item questionnaire; measures difficulty level of and 8 common evening behaviors (such as, sit through dinner) and 3 common morning behaviors (such as, get out of bed). Each item is scored on a 4-point Likert scale ranging from 0 (no difficulty) to 3 (a lot of difficulty). Total score (evening+morning) range is 0 to 33. Higher scores indicate greater difficulty in evening and morning behavior. DPREMB-R total score between days without missing doses (on-days) and days with missing doses (off-days) was not analyzed due to the insufficient sample size.|Baseline through 4 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.|||||
818598|NCT01127659|Secondary|Inflammation||6 months||||||
818599|NCT01127659|Secondary|Body Composition||6 months||||||
818600|NCT01127659|Primary|Insulin Sensitivity|measured by HE clamps (baseline and 6 mths)|6 months|Glucose infusion rate in HE clamps was measured||mg/kg fat free mass/min||Standard Deviation|Mean
818601|NCT01127737|Primary|Number of Control and Intervention Participants on Skin Self-examination Performance at Follow-up 1 Month After Intervention|The number of control and intervention participants who checked their skin for cancer within the 1 month after the study visit.|1 month|Per protocol||Participants|||Number
818602|NCT01127763|Primary|Toxicity Profile-Non Hematological|Reported as percentage of patients who experienced grade 3 and higher non-hematological AEs related to the study drugs.|treatment period (up to 1 year) plus 30 days off treatment|any patient who received at least 1 dose of protocol treatment.||percentage of patients|||Number
818603|NCT01127763|Secondary|Median Progression-free Survival Time|Progression-free survival time is defined as the time from first day of treatment to the first date of disease progression or death as a result of any cause. Progression was assessed every 2 cycles of treatment (6 weeks) by CT, CT/PET, or MRI. Progression is defined using RECIST 1.0, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|up to 1 year|Any patient with at least one dose of treatment.||months||95% Confidence Interval|Median
818604|NCT01127763|Primary|Toxicity Profile-Hematological|Reported as percentage of patients who experienced grade 3 and higher hematological adverse events (AEs) related to the study drugs.|treatment period (up to 1 year) plus 30 days off treatment|any patient who received at least 1 dose of protocol treatment.||percentage of patients|||Number
818605|NCT01127763|Primary|Clinical Benefit Rate (Complete Response, Partial Response, and Stable Disease That Lasts More Than 6 Months)|Clinical benefit rate is defined as the number of patients with complete response (CR), partial response (PR), or stable disease (SD) that lasts at least 6 months. Response was assessed every 2 cycles of treatment (6 weeks) by computed tomography (CT), CT/positron emission tomography (PET), or magnetic resonance imaging (MRI). Overall response evaluation is based on Response Evaluation Criteria In Solid Tumors 1.0 (RECIST 1.0). Per RECIST 1.0 for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|up to 1 year|Any patient with at least one dose of treatment.||percentage of patients||95% Confidence Interval|Number
818606|NCT01128049|Primary|Visual Quality|Average visual quality change over a 5 second blink cycle caused by movement of the tears over the surface of the eye by measuring optical irregularities.|5 seconds|The comparison was between normal, non-dry eye participants and dry eye groups.||microns||Standard Deviation|Mean
818607|NCT01128114|Secondary|The Mean Change From Baseline to Week 4 in CGI-S (Clinical Global Impression-Severity of Illness) Score|The CGI-S is scored to rate patient’s current clinical state. At enrolment patient’s condition is rated using the CGI-S. At assignment CGI-S is again completed and a score of at least 4 (moderately ill). The score at assignment Day 1 will be regarded as the baseline value. At all following visits CGI-S will be rated. Each CGI item is scored on a scale from 1 to 7. A CGI-S score of 1 indicates that a patient is “Normal, not at all ill” and a score of 7 indicates that a patient is “Among the most extremely ill patients”.|Baseline, week 4||||||
818645|NCT01128296|Secondary|Disease-free Survival by p53 Genetic Status||Up to 35 months|Participants that completed more than 80 % of the intended dose of HCQ.||months||95% Confidence Interval|Median
818609|NCT01128114|Secondary|The Mean Change From Baseline to Week 4 in - YMRS (Young Mania Rating Scale) Total Score|The YMRS is an 11-item, multiple-choice diagnostic questionnaire which psychiatrists use to measure severity of manic episodes. There are 4 items graded on a 0 to 8 scale (irritability, speech, thought content, disruptive/aggressive behavior), and 7 items graded on 0 to 4 scale. These 4 items are given twice the weight of the others to compensate for poor cooperation from severely ill patients. Typical YMRS baseline scores can vary a lot. They depend on patients’ clinical features such as mania (YMRS = 12), depression (YMRS = 3), or euthymia (YMRS = 2.|Baseline, week 4||||||
818610|NCT01128114|Primary|The Proportion of Patients With Improvement From Baseline to Week 4 in Clinical Global Impression-Clinical Benefit Score (LOCF)|CGI-CB is used to evaluate the investigator's global weighted impression of efficacy and interference of adverse event from baseline to every visit. Improvement in clinical benefit is defined as a decrease from baseline in CGI-CB. Rank 1 denotes best possible benefit from new treatment and rank 10 indicates that there is no benefit from treatment.|Baseline, week 4|As the study was terminated prematurely none of the randomized patients have been analysed.||Participants|||Number
818611|NCT01128153|Secondary|Proportion of Participants Achieving a Therapeutic Response: HbA1c Less Than 7% at Week 24, Last Observation Carried Forward (LOCF)|Number of participants achieving a glycaemic response defined as HbA1c less than 7% at Week 24|From Baseline to Week 24|Full Analysis Set which included all participants randomised to the study who received at least 1 dose of investigational product and who had a non-missing baseline value and at least 1 post-baseline measure. The full analysis set follows intention-to-treat principle.||Participants|||Number
818612|NCT01128153|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mmol/L]|Adjusted Mean Change in FPG from baseline to Week 24 using analysis of covariance model|From Baseline to Week 24|Full Analysis Set which included all participants randomised to the study who received at least 1 dose of investigational product and who had a non-missing baseline value and at least 1 post-baseline measure. The full analysis set follows intention-to-treat principle.||mmol/L||95% Confidence Interval|Mean
818613|NCT01128153|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mg/dL]|Adjusted Mean Change in fasting plasma glucose from baseline to Week 24 using analysis of covariance|From Baseline to Week 24|Full Analysis Set which included all participants randomised to the study who received at least 1 dose of investigational product and who had a non-missing baseline value and at least 1 post-baseline measure. The full analysis set follows intention-to-treat principle.||mg/dL||95% Confidence Interval|Mean
818614|NCT01128153|Secondary|Change in 2-hour Postprandial Glucose (PPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mmol/L]|Adjusted Mean Change in 2-hour PPG from baseline to Week 24 using analysis of covariance model|From Baseline to Week 24|Full Analysis Set which included all participants randomised to the study who received at least 1 dose of investigational product and who had a non-missing baseline value and at least 1 post-baseline measure. The full analysis set follows intention-to-treat principle.||mmol/L||95% Confidence Interval|Mean
818615|NCT01128153|Secondary|Change in 2-hour Postprandial Glucose (PPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mg/dL]|Adjusted Mean Change in 2-hour PPG from baseline to Week 24 using analysis of covariance model|From Baseline to Week 24|Full Analysis Set which included all participants randomised to the study who received at least 1 dose of investigational product and who had a non-missing baseline value and at least 1 post-baseline measure. The full analysis set follows intention-to-treat principle.||mg/dL||95% Confidence Interval|Mean
818616|NCT01128153|Primary|Change in HbA1c From Baseline to Week 24, Last Observation Carried Forward (LOCF)|Adjusted Mean Change in HbA1c from baseline to Week 24 using analysis of covariance model|From Baseline to Week 24 weeks|Full Analysis Set which included all participants randomised to the study who received at least 1 dose of investigational product and who had a non-missing baseline value and at least 1 post-baseline measure. The full analysis set follows intention-to-treat principle.||percent||95% Confidence Interval|Mean
818617|NCT01128179|Secondary|Change From Baseline in Calcium-Phosphate Product Values at Week 12 (LOCF)||12 weeks|PP||mmol^2/L^2||Standard Error|Least Squares Mean
818618|NCT01128179|Secondary|Change From Baseline in Serum Total Calcium Values at Week 12 (LOCF)||12 weeks|PP||mmol/L||Standard Error|Least Squares Mean
818619|NCT01128179|Secondary|Change From Baseline in Serum Phosphate Values at Week 12 (LOCF)||12 weeks|PP||mmol/L||Standard Error|Least Squares Mean
818620|NCT01128179|Secondary|Change From Baseline in Urinary Fractional Excretion of Phosphate Values at Week 12 (LOCF)||12 weeks|PP||percentage of excretion of phosphate||Standard Error|Least Squares Mean
818621|NCT01128179|Secondary|Change From Baseline in 1,25-Dihydroxy Vitamin D Values at Week 12 (LOCF)||12 weeks|PP||pg/ml||Standard Error|Least Squares Mean
818622|NCT01128179|Secondary|Change From Baseline in Serum Intact Parathyroid Hormone (iPTH) Values at Week 12 (LOCF)||12 Weeks|PP||pg/ml||Standard Error|Least Squares Mean
818623|NCT01128179|Primary|Natural Logarithm Transformed Serum Intact Fibroblast Growth Factor (FGF-23) Levels at Week 12 Last Observation Carried Forward (LOCF)|FGF-23 plays an important role in mineral metabolism in chronic kidney disease patients. It is secreted by bone cells in response to hyperphosphatemia. It acts to decrease renal phosphate reabsorption. Administration of a phosphate-binder (i.e. lanthanum carbonate) was expected to produce a reduction in FGF-23 levels.|12 Weeks|Per-protocol (PP) set are subjects who received at least 1 dose of investigational product and who had primary data assessment available from Week 2 or later and who did not have pre-defined major protocol deviations that could have affected the primary variable.||pg/ml||Standard Error|Least Squares Mean
818624|NCT01128192|Primary|Change in High-Dose Glucose Disposal Rate (GDR)|Change from Day 3 and Day 10 in High-Dose Glucose Disposal Rate (GDR) during Hyperinsulinemic-Euglycemic Clamp.|Day 3 and Day 10|||mg/kg/min||Standard Deviation|Mean
818625|NCT01128192|Primary|Change in Low-Dose Glucose Disposal Rate (GDR)|Change from Day 3 and Day 10 in Low-Dose Glucose Disposal Rate (GDR) during Hyperinsulinemic-Euglycemic Clamp.|Day 3 and Day 10|||mg/kg/min||Standard Deviation|Mean
818626|NCT01128192|Primary|Change in High Dose % Endogenous Glucose Production (EGP) Inhibition|Change from Day 3 and Day 10 of high dose % EGP Inhibition (Hyperinsulinemic-Euglycemic Clamp)|Day 3 and Day 10|||percentage of EGP inhibition||Standard Deviation|Mean
818629|NCT01128192|Primary|Change in Area Under the Curve (AUC) of Plasma Insulin Level 0-10mins, 10-180mins, 0-180mins During Hyperglycemic Clamp|Blood samples were taken at -30 min, -15 min, 0 min, 15 min, 30 min, 45 min, 60 min, 75 min, 90 min, 105 min, 120 min, 135 min, 150 min, 165 min, 180 min to assess the plasma insulin levels during Hyperglycemic Clamp (2-step hyperglycemic clamp test with arginine stimulation). The mean change in plasma insulin levels from Day 2 to Day 9 were calculated as Values on Day 9 - Values on Day 2.|0-10 mins, 10-180 mins, 0-180 mins (Day 2 and Day 9)|||h*pmol/L||Standard Deviation|Mean
818630|NCT01128192|Primary|Change in Insulin Basal Level|Change from Day 2 and Day 9 of insulin basal levels (2-step hyperglycemic clamp test with arginine stimulation)|-30 min and -15 min on Day 2 and Day 9|||pmol/L||Standard Deviation|Mean
818631|NCT01128192|Secondary|Change in Area Under the Curve (AUC) of Plasma Insulin 0-30mins, 30-180mins, 0-180mins During Oral Glucose Tolerance Test (OGTT)|Blood samples were taken at -30 min, 0 min, 30 min, 60 min, 90 min, 120 min, 150 min, 180 min to assess the plasma insulin level. The mean change in plasma insulin level from Day 1 to Day 8 were calculated as Values on Day 8 - Values on Day 1|0-30 mins, 30-180 mins, 0-180 mins (Day 1 and Day 8)|||h*pmol/L||Standard Deviation|Mean
818632|NCT01128192|Secondary|Change Fasting Plasma Insulin Level|An Oral Glucose Tolerance Test was performed at Day 1 (baseline) and Day 8 (post-treatment). Samples were taken at -30 min to assess the fasting plasma insulin level. The mean change in fasting plasma insulin level from Day 1 to Day 8 was assessed.|-30 minutes on Day 1 and -30 minutes on Day 8|||pmol/L||Standard Deviation|Mean
818633|NCT01128192|Secondary|Change in Area Under the Curve (AUC) of Plasma Glucose 0-30mins, 30-180mins, 0-180mins During Oral Glucose Tolerance Test (OGTT)|Blood samples were taken at -30 min, 0 min, 30 min, 60 min, 90 min, 120 min, 150 min, 180 min to assess the plasma glucose level. The mean change in plasma glucose level from Day 1 to Day 8 were calculated as Values on Day 8 - Values on Day 1.|0-30 mins, 30-180 mins, 0-180 mins (Day 1 and Day 8)|||h*mmol/L||Standard Deviation|Mean
818634|NCT01128192|Secondary|Change in Fasting Plasma Glucose Level|"An Oral Glucose Tolerance Test was performed at Day 1 (baseline) and Day 8 (post-treatment). Samples were taken at
-30 min to assess the fasting plasma glucose level. The mean change in fasting plasma glucose level from Day 1 to Day 8 was assessed."|-30 minutes on Day 1 and -30 minutes on Day 8|||mmol/L||Standard Deviation|Mean
818635|NCT01128244|Secondary|Plasma 3-hydroxykynurenine Concentration|For all subjects, analysis of blood samples before and after vitamin B6 supplementation will allow evaluation of discriminating biomarkers using targeted metabolite profile analysis of one-carbon metabolism and tryptophan catabolism constituents. Also, we will conduct exploratory evaluation and potential identification of new biomarkers using metabolomics analysis on subjects before and after vitamin B6 supplementation.|April, 2010 - June, 2014|Women using oral contraceptives and exhibiting low vitamin B6 status.||microl/L||Standard Deviation|Mean
818636|NCT01128244|Primary|Fasting Plasma Cystathionine Concentration|For all subjects, the concentration of plasma cystathionine in fasting blood samples taken before and after the supplementation period will provide a functional measure of vitamin B6 nutritional status.|Fasting blood samples will be taken at baseline and after 28 days of vitamin B6 supplementation.|Women using oral contraceptives and exhibiting low vitamin B6 status.||micromol/L||Standard Deviation|Mean
818637|NCT01128244|Primary|Fasting Plasma Pyridoxal Phosphate Concentration|For all subjects, the concentration of plasma pyridoxal phosphate in fasting blood samples taken before and after the supplementation period will provide a direct measure of vitamin B6 nutritional status.|Fasting blood samples will be taken at baseline and after 28 days of vitamin B6 supplementation.|Women using oral contraceptives and exhibiting low vitamin B6 status.||nmol/L||Standard Deviation|Mean
818638|NCT01128244|Primary|Flux of Homocysteine Remethylation From Serine-derived Carbon|Data from analysis of serine, methionine and leucine in the timed blood samples of all subjects will provide a measurement of the metabolic rate of homocysteine remethylation from serine-derived carbon before and after vitamin B6 supplementation. These flux values may be slightly higher than flux of total homocysteine remethylation in Outcome Measure 1 because of the small contribution of methionine salvage to the flux measured in Outcome Measure 2.|Blood samples will be taken prior to infusion and at 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7.5, and 9h. Infusions will be conducted at baseline and after 28 days|Women using oral contraceptives and exhibiting low vitamin B6 status.||micromol/(kg x hr)||Standard Deviation|Mean
818639|NCT01128244|Primary|Total Remethylation of Homocysteine|Data from analysis of serine, methionine and leucine in the timed blood samples of all subjects will provide a measurement of the metabolic rate of total remethylation of homocysteine before and after vitamin B6 supplementation.|Blood samples will be taken prior to infusion and at 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7.5, and 9h. Infusions will be conducted at baseline and after 28 days|Women using oral contraceptives exhibiting low vitamin B6 status evaluated at baseline and after vitamin B6 supplementation.||micromol/(kg x hr)||Standard Deviation|Mean
818640|NCT01128270|Secondary|Detectable DCA After Day 1 in Serum (0=No 1=Yes)|All four arms receive Chloral Hydrate on Day 1 (arms 1A and 1B environmental levels) and (arms 2A and 2B therapeutic levels). The question is could Dichloroacetate be detected in serum at the end of day 1. This analysis is purely descriptive, and no comparisons were planned.|1 day|All eligible session completers||participants|||Number
818641|NCT01128270|Primary|Urinary Maleylacetone Levels After 5 Day Exposure to Therapeutic Chloral Hydrate (Arm 2B)|The levels were clinically indetectable at baseline and the question was whether or not substantive levels would be noted at after 5 days exposure to Chloral Hydrate. Detectable, but low levels were detected.|5 days|all eligible participants to arm 2B (Period 4)||micrograms per ml clorohydrate||Standard Deviation|Mean
818642|NCT01128270|Primary|Difference in Half Lives 5 Day Less One Day Exposure in Trichloroacetate|Elimination Half-life Difference on Arm 2B for 13C-Labeled trichloroacetate between day 5 (prolonged exposure) and day 1 (de novo exposure) after therapeutic level exposure to Chloral Hydrate. This outcome only applies to Period 4. Trichloroacetate is a marker, not an intervention.|5 days|This applies only to Arm 2B (Therapeutic Chloral Hydrate without DCA.||minutes||Standard Deviation|Mean
818643|NCT01128270|Primary|Plasma DCA (Microgram/ml) After 5 Days of Therapeutic Level Chloral Hydrate on Arm 2A.|After 5 days of of therapeutic level Chloral Hydrate, the levels of Dichloroacetate in the plasma were measured.|6 Days|||micrograms/ml||Standard Deviation|Mean
818644|NCT01128296|Secondary|Overall Survival (OS) by p53 Mutant Status||Up to 35 months|Participants that completed more than 80 % of the intended dose of HCQ.||months||95% Confidence Interval|Median
818646|NCT01128296|Secondary|Overall Survival (OS) by CA 19-9 Response|Median number of months of overall survival for participants who experienced Ca 19-9 (surrogate biomarker) response (either an increase or decrease in Ca 19-9), or, no Ca 19-9 response. Per participant increases in Ca 19-9 ranged from >0 to 225%. Per participant decreases in Ca 19-9 ranged from >0 to 100%.|Up to 35 months|Analysis population included participants who received study treatment, who experienced either an increase or decrease in Ca 19-9, or no Ca 19-9 surrogate biomarker response||months||95% Confidence Interval|Median
818647|NCT01128296|Secondary|Disease-free Survival (DFS) by CA 19-9 Response|Median number of months of disease-free survival for participants who experienced Ca 19-9 (surrogate biomarker) response (either an increase or decrease in Ca 19-9), or no Ca 19-9 response. Per participant increases in Ca 19-9 ranged from >0 to 225%. Per participant decreases in Ca 19-9 ranged from >0 to 100%.|Up to 30 months|Analysis population included a total of 26 participants who received study treatment, who experienced either an increase or decrease in Ca 19-9, or no Ca 19-9 surrogate biomarker response.||months||95% Confidence Interval|Median
818648|NCT01128296|Secondary|R0 Resection Rate|Number of participants that underwent a resection with microscopically margin-negative resection in which no gross or microscopic tumor remains in the primary tumor bed (24) / number of that completed treatment (31)|Up to 30 months|Participants that completed more than 80 % of the intended dose of HCQ.||percentage of participants|||Number
818649|NCT01128296|Secondary|Overall Survival (OS) by Response to HCQ Treatment|Median number of months of overall survival in participants who did and did not experience response to HCQ treatment. Patients who had >51 % increase in their LC3-II staining were classified as having a response to HCQ.|Up to 35 months|Subset of participants that completed more than 80 % of the intended dose of HCQ.||months||95% Confidence Interval|Median
818650|NCT01128296|Secondary|Disease-free Survival (DFS) by Response to HCQ Treatment|Median number of months of disease-free survival in participants who did and did not experience response to HCQ treatment. Patients who had >51 % increase in their LC3-II staining were classified as having a response to HCQ.|Up to 30 months|Subset of participants that completed more than 80% of the intended dose of HCQ treatment.||months||95% Confidence Interval|Median
818651|NCT01128296|Secondary|Overall Survival (OS)|Median number of months of overall survival for participants receiving study treatment.|Up to 35 months|Participants that completed more than 80% of the intended dose of HCQ.||months||95% Confidence Interval|Median
818652|NCT01128296|Secondary|Disease-free Survival (DFS)|Median number of months of disease-free survival for participants receiving study treatment.|Up to 30 months|Participants that completed more than 80 % of the intended dose of HCQ.||months||95% Confidence Interval|Median
818653|NCT01128296|Primary|Number of Participants That Experienced a Dose Limiting Toxicity (DLT)|Number of Participants at each dose level of HCQ that experienced a Dose Limiting Toxicity (DLT).|Up to 31 days|Observed for dose-limiting toxicities or treatment delays attributed to HCQ to determine the maximum tolerated dose.||participants|||Number
818654|NCT01128361|Primary|Cornell Scale for Depression in Dementia|The Cornell Scale for Depression in Dementia is a validate measure of depressive symptoms in individuals with dementia. Larger numbers indicate greater levels of depression. Scores range from 0 to 38.|Week 0, 13, and 26|Linear mixed models were used with all available data. Overall numbers analyzed may not reflect numbers at each timepoint||units on a scale||Standard Deviation|Mean
818655|NCT01128361|Primary|Disability Assessment for Dementia|This is a validated measure of disability for individuals with dementia. Higher scores indicate less disability with a score of 100 indicating no disability and 0 indicating no functional ability.|Week 0, 13, and 26|Linear mixed models were used with all available data. Overall number of participants may not match numbers at each timepoint.||percentage on a scale||Standard Deviation|Mean
818656|NCT01128361|Primary|Executive Function Composite|"A composite measure of several memory tests (Logical Memory (Immediate and Delayed), Free and Cued Selective Reminding Test (sum of free recall). Each score was normalized to an independent dataset. Then the 4 standardized scores were averaged.
Numbers closer to positive indicate better executive function performance. . The scores are centered around a mean of 0 and standardized so each value represents a fraction of the standard deviation. There are no limits to the scores."|Week 0, 13, and 26|Linear mixed models were used with all available data included. Overall numbers analyzed do not necessarily match the outcome measure at each timepoint||standardized units on a scale||Standard Deviation|Mean
818657|NCT01128361|Primary|Memory Composite|"A composite measure of several memory tests (Logical Memory (Immediate and Delayed), Free and Cued Selective Reminding Test (sum of free recall). Each score was normalized to an independent dataset of individuals without dementia. Then the 4 standardized scores were averaged.
Numbers closer to positive indicate better memory performance. The scores are centered around a mean of 0 and standardized so each value represents a fraction of the standard deviation. There are no limits to the scores."|week 0, 13, and 26|Linear mixed models with all available data were used. Thus the overall number of participants analyzed does not necessarily match the means reported at each timepoint.||units on a standardized scale||Standard Deviation|Mean
818658|NCT01128400|Primary|Triolein Detection|We will measure triolein detection levels as a marker of subjects' ability to detect triglyceride.|Few weeks after screening|||log10 (%W/V TRIOLEIN)||Standard Error|Mean
818659|NCT01128400|Primary|Oleic Acid Detection Level|We will measure oleic acid detection levels as a marker of subjects' ability to detect free fatty acids.|Few weeks after screening|||log10 (%W/V OLEIC ACID)||Standard Error|Mean
818660|NCT01128413|Primary|Lactate Clearance|The median lactate clearance from time zero to within 6 hours of the ED stay.|The median lactate clearance within 6 hours of the ED stay.|Only 9 total patients (5 Fluid Optimization; 4 Routine Care) stayed in the Emergency Department for a full 6 hours to allow calculation of a 6 hour lactate clearance. The rest of the patients left were dispositioned out of the ED before the 6 hour mark and therefore unable to calculate a 6 hour lactate clearance.||percent lactate clearance||Inter-Quartile Range|Median
818741|NCT01121900|Primary|Bioequivalence Based on AUC(0-∞)|"AUC(0-∞) = Area under the plasma concentration curve vs time data pairs, with extrapolation to infinity (∞).
Measured in nanogram x hours per milliliter (ng*h/mL)."|68 hours|The dataset for pharmacokinetic analysis comprised the 23 subjects who completed the study as per protocol.||h*ng/mL||Standard Deviation|Mean
818835|NCT01122576|Secondary|Monocular Halo and Starburst|Halo and starburst (both monocular and binocular) were measured using a glarometer on integer scales of 1-5, where the smaller the number the better the outcome.|Visit 4 (4-6 months)|Full Analysis Set||units on a scale|Participants|Standard Deviation|Mean
818661|NCT01128426|Primary|Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined|Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). For primary series (Dose 1, 2, 3 combined), all 30-day risk windows and all post-dose 30-day control windows were summed. Relative risk in in inpatient and emergency department health care setting for primary series was assessed by comparing the combined incidence rate of reported events in both the settings per 1000 person-months occurring within 30 days after Dose 1, 2, and 3 (risk window) with the combined self-control period occurring during the subsequent 30 days for each dose (self-control windows after risk window for each dose). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.|30 days after Dose 1, 2, 3 combined (risk window for primary series), 30 days after risk window for Dose 1, 2, 3 combined (post-dose self-control window for primary series)|Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 3 doses of 13vPnC vaccine during the study observation period.||ratio||90% Confidence Interval|Number
818662|NCT01128426|Primary|Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department|Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). For primary series (Dose 1, 2, 3 combined), all 30-day risk windows and all post-dose 30-day control windows were summed. Relative risk in emergency department health care setting for primary series was assessed by comparing the combined incidence rate of reported events in emergency department setting per 1000 person-months occurring within 30 days after Dose 1, 2, and 3 (risk window) with the combined self-control period occurring during the subsequent 30 days for each dose (self-control windows after risk window for each dose). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.|30 days after Dose 1, 2, 3 combined (risk window for primary series), 30 days after risk window for Dose 1, 2, 3 combined (post-dose self-control window for primary series)|Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 3 doses of 13vPnC vaccine during the study observation period.||ratio||90% Confidence Interval|Number
818663|NCT01128426|Primary|Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient|Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). For primary series (Dose 1, 2, 3 combined), all 30-day risk windows and all post-dose 30-day control windows were summed. Relative risk in inpatient health care setting for primary series was assessed by comparing the combined incidence rate of reported events in inpatient setting per 1000 person-months occurring within 30 days after Dose 1, 2, and 3 (risk window) with the combined self-control period occurring during the subsequent 30 days for each dose (self-control windows after risk window for each dose). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.|30 days after Dose 1, 2, 3 combined (risk window for primary series), 30 days after risk window for Dose 1, 2, 3 combined (post-dose self-control window for primary series)|Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 3 doses of 13vPnC vaccine during the study observation period.||ratio||90% Confidence Interval|Number
818664|NCT01128426|Primary|Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined|Relative risk for given event=incidence rate(risk window)/incidence rate(self-control window). Relative risk in inpatient and emergency department health care setting for Dose 3 was assessed by comparing the overall incidence rates of reported events in both settings per 1000 person-months occurring within 30 days after Dose 3 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results reported for events reported in either of the windows.|30 days after Dose 3 (risk window for Dose 3), 30 days after risk window (post-dose self-control window for Dose 3)|Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 3 doses of 13vPnC vaccine during the study observation period.||ratio||90% Confidence Interval|Number
818665|NCT01128426|Primary|Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department|Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in emergency department health care setting for Dose 3 was assessed by comparing the incidence rate of reported events in emergency department setting per 1000 person-months occurring within 30 days after Dose 3 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and its corresponding exact 2-sided 90% confidence CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.|30 days after Dose 3 (risk window for Dose 3), 30 days after risk window (post-dose self-control window for Dose 3)|Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 3 doses of 13vPnC vaccine during the study observation period.||ratio||90% Confidence Interval|Number
818666|NCT01128426|Primary|Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient|Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in inpatient health care setting for Dose 3 was assessed by comparing the incidence rate of reported events in inpatient setting per 1000 person-months occurring within 30 days after Dose 3 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.|30 days after Dose 3 (risk window for Dose 3), 30 days after risk window (post-dose self-control window for Dose 3)|Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 3 doses of 13vPnC vaccine during the study observation period.||ratio||90% Confidence Interval|Number
818667|NCT01128426|Primary|Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined|Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in inpatient and emergency department health care setting for Dose 2 was assessed by comparing the overall incidence rates of reported events in both settings per 1000 person-months occurring within 30 days after Dose 2 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results reported for events reported in either of the windows.|30 days after Dose 2 (risk window for Dose 2), 30 days after risk window (post-dose self-control window for Dose 2)|Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 2 doses of 13vPnC vaccine during the study observation period.||ratio||90% Confidence Interval|Number
818668|NCT01128426|Primary|Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department|Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in emergency department health care setting for Dose 2 was assessed by comparing the incidence rate of reported events in emergency department setting per 1000 person-months occurring within 30 days after Dose 2 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.|30 days after Dose 2 (risk window for Dose 2), 30 days after risk window (post-dose self-control window for Dose 2)|Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 2 doses of 13vPnC vaccine during the study observation period.||ratio||90% Confidence Interval|Number
818669|NCT01128426|Primary|Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient|Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in inpatient health care setting for Dose 2 was assessed by comparing the incidence rate of reported events in inpatient setting per 1000 person-months occurring within 30 days after Dose 2 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.|30 days after Dose 2 (risk window for Dose 2), 30 days after risk window (post-dose self-control window for Dose 2)|Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 2 doses of 13vPnC vaccine during the study observation period.||ratio||90% Confidence Interval|Number
818670|NCT01128426|Primary|Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined|Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in inpatient and emergency department health care setting for Dose 1 was assessed by comparing the overall incidence rates of reported events in both settings per 1000 person-months occurring within 30 days after Dose 1 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.|30 days after Dose 1 (risk window for Dose 1), 30 days after risk window (post-dose self-control window for Dose 1)|Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 1 dose of 13vPnC vaccine during the study observation period.||ratio||90% Confidence Interval|Number
818671|NCT01128426|Primary|Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department|Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in emergency department health care setting for Dose 1 was assessed by comparing the incidence rate of reported events in emergency department setting per 1000 person-months occurring within 30 days after Dose 1 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.|30 days after Dose 1 (risk window for Dose 1), 30 days after risk window (post-dose self-control window for Dose 1)|Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 1 dose of 13vPnC vaccine during the study observation period.||ratio||90% Confidence Interval|Number
818672|NCT01128426|Primary|Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient|Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in inpatient health care setting for Dose 1 was assessed by comparing the incidence rate of reported events in inpatient setting per 1000 person-months occurring within 30 days after Dose 1 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% (CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.|30 days after Dose 1 (risk window for Dose 1), 30 days after risk window (post-dose self-control window for Dose 1)|Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 1 dose of 13vPnC vaccine during the study observation period.||ratio||90% Confidence Interval|Number
818742|NCT01121900|Primary|Bioequivalence Based on AUC(0-tlast)|"AUC(0-tlast) = Area under the plasma concentration curve (AUC) vs (versus) time data pairs, where tlast is the time of the last quantifiable concentration.
Measured in nanogram x hours per milliliter (ng*h/mL)."|68 hours|The dataset for pharmacokinetic analysis comprised the 23 subjects who completed the study as per protocol.||hr*ng/mL||Standard Deviation|Mean
818743|NCT01121900|Primary|Bioequivalence Based Cmax|Cmax = Maximum plasma concentration. Measured in nanogram per milliliter (ng/mL).|68 hours|The dataset for pharmacokinetic analysis comprised the 23 subjects who completed the study as per protocol.||ng/mL||Standard Deviation|Mean
818673|NCT01128426|Primary|Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined|Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in inpatient and emergency department health care setting for pre-dose 1 was assessed by comparing the overall incidence rates of reported events in both settings per 1000 person-months occurring within 30 days after Dose 1 (30-day risk window) with self-control period occurring during 30 days before Dose 1 (pre-vaccination 30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.|30 days before Dose 1 (-34 to -5 days before Dose 1, pre-vaccination self-control window for Dose 1), 30 days after Dose 1 (risk window for Dose 1)|Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 1 dose of 13vPnC vaccine during the study observation period.||ratio||90% Confidence Interval|Number
818674|NCT01128426|Primary|Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department|Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in emergency department health care setting for pre-dose 1 was assessed by comparing the incidence rate of reported events in emergency department setting per 1000 person-months occurring within 30 days after Dose 1 (30-day risk window) with self-control period occurring during 30 days before Dose 1 (pre-vaccination 30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.|30 days before Dose 1 (-34 to -5 days before Dose 1, pre-vaccination self-control window for Dose 1), 30 days after Dose 1 (risk window for Dose 1)|Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 1 dose of 13vPnC vaccine during the study observation period.||ratio||90% Confidence Interval|Number
818675|NCT01128426|Primary|Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient|Relative risk for given event=incidence rate(risk window)/incidence rate(self-control window).Relative risk in inpatient health care setting for pre-dose 1 assessed by comparing incidence rate of reported events in inpatient setting/1000 person-months occurring within 30 days after Dose 1(30-day risk window) with self-control period occurring during 30 days before Dose 1(pre-vaccination 30-day self-control window).Relative risk,exact 2-sided 90 percent (%) confidence intervals (CIs) reported. Medically attended events documented retrospectively according to International Classification of Diseases, ninth Revision (ICD-9) coding.Medical attended event acute bronchiolitis due to Respiratory Syncytial Virus (RSV) has been represented as acute bronchiolitis due to RSV and acute pyelonephritis without renal medullary necrosis(RMN) lesion has been represented as acute pyelonephritis without RMN lesion in measure categories below.Results reported for events reported in either of the windows.|30 days before Dose 1 (-34 to -5 days before Dose 1, pre-vaccination self-control window for Dose 1), 30 days after Dose 1 (risk window for Dose 1)|Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 1 dose of 13vPnC vaccine during the study observation period.||ratio||90% Confidence Interval|Number
818676|NCT01128543|Secondary|Duration of Response|Duration of response was measured in participants who experienced either a complete response or a partial response. Per RECIST, Version 1.1, complete response is defined as the disappearance of all target lesions, and partial response is defined as a >=30% decrease in the sum of the longest diameter of target lesions, taking as a reference the baseline sum longest diameter.|From the start of treatment until a complete response or partial response was reached (up to Week 90; average of 21.3 weeks)|All participants randomized to receive at least one dose of study drug. Only those participants with a complete or partial response were evaluated.||months||Inter-Quartile Range|Median
818677|NCT01128543|Secondary|Progression-free Survival|Per RECIST, Version 1.1, Progressive Disease is defined as at least a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|From the start of treatment until disease progression, death, or discontinuation from the study (average of 102.7 months)|All participants randomized to receive at least one dose of study drug. Of the 29 participants enrolled in the study, 25 were evaluable for analysis; 4 participants withdrew from the study.||months||Standard Deviation|Mean
818678|NCT01128543|Primary|Number of Participants (Par.) With Clinical Benefit (CB) at Week 12 and Week 24|Par. with CB are defined as those with complete response (CR), partial response (PR), or stable disease (SD) for >=12 or 24 weeks. Per Response Evaluation Criteria In Solid Tumors (RECIST), Version 1.1, CR is defined as the disappearance of all target lesions, PR is defined as a >=30% decrease in the sum of the longest diameter (LD) of target lesions, taking as a reference the baseline sum LD, and SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as a reference the smallest sum LD since the treatment started.|Week 12 and Week 24|All participants randomized to receive at least one dose of study drug. Of the 29 participants enrolled in the study, 25 were evaluable for analysis; 4 participants withdrew from the study.||participants|||Number
818679|NCT01128569|Secondary|Number of Participants With Treatment-emergent Adverse Events (AEs)|The number of participants with treatment-emergent AEs was measured. A treatment-emergent adverse event is defined as any event not present prior to the initiation of the treatments, or any event already present that worsens in either intensity of frequency following exposure to the treatments.|From the start of study medication until Follow-up/Early Withdrawal (up to 197 days)|ITT Population||participants|||Number
818744|NCT01121913|Secondary|Apparent First Order Terminal Rate Constant [λz]|Apparent First order terminal rate constant [λz] of trazodone in plasma expressed in 1/hours.|72 hours|The dataset for pharmacokinetic analysis comprised the 19 subjects who completed the study as per protocol.||1/hours||Standard Deviation|Mean
818745|NCT01121913|Secondary|Time to the Maximum Concentration (Tmax)||72 hours|The dataset for pharmacokinetic analysis comprised the 19 subjects who completed the study as per protocol.||Hours||Full Range|Median
818746|NCT01121913|Secondary|Apparent Terminal Half-life (t½.z)|Apparent terminal half-life (t½.z) of trazodone in hours|72 hours|The dataset for pharmacokinetic analysis comprised the 19 subjects who completed the study as per protocol.||Hours||Standard Deviation|Mean
818680|NCT01128569|Secondary|Minimum FEV1 Absolute Change From Baseline Between 0–2 Hour, Following the 22–23 Hour Post-treatment Allergen Challenge on Day 29 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 22-23 hours after dosing on Day 28. Immediately prior to the exposure of allergen and starting at 2 minutes after inhalation of saline, 3 single measurements of FEV1were recorded at 1-minute intervals, and the best was taken as the post-saline value. The minimum FEV1 over 0-2 hours post-allergen challenge (PAC) (minimum early asthmatic response) was the minimum value of all of the PAC time points up to and including 2 hours PAC (i.e., minimum over 5 minutes (min), 10 min, 15 min, 20 min, 30 min, and 45 min and 1 hour, 1.5 hours, and 2 hours). Change from Baseline was calculated using the post-saline FEV1 on Day 29 as Baseline. Minimum FEV1 absolute change from Baseline between 0–2 hour, following the 22–23 hour post-treatment allergen challenge was calculated as the minimum change value on Day 29 minus the Baseline value|Baseline and Day 29 of each treatment period (up to Study Day 197)|ITT Population. Only those participants available at the specified time points were analyzed. Analysis was performed using mixed model ANCOVA with fixed effects of treatment, period, participant-level Baseline, period level Baseline, country, sex, and age.||Liters||Standard Error|Least Squares Mean
818681|NCT01128569|Secondary|Maximum Percent Decrease From Baseline in FEV1 Between 0 2 Hour, Following the 22–23 Hour Post-treatment Allergen Challenge on Day 29 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 22-23 hours after dosing on Day 28. Immediately prior to the exposure of allergen and starting at 2 minutes (min) after inhalation of saline, 3 single measurements of FEV1were recorded at 1-min intervals, and the best was taken as the post-saline value. The maximum change (i.e., drop in FEV1) from post-saline Baseline (BL) is defined by ordering all of the change from BL values for the 5 min, 10 min, 15 min, 20 min, 30 min, and 45 min and the 1 hour, 1.5 hours, and 2 hours post-allergen challenge and selecting the largest change (i.e., drop in FEV1) from the BL value. If there were no negative change values, indicating a worse FEV1 value as compared to the BL value, the smallest change in FEV1, indicating an improvement from the BL value, was selected. The BL FEV1 value was the post-saline value on Day 29.|Baseline and Day 29 of each treatment period (up to Study Day 197)|ITT Population. Only those participants available at the specified time points were analyzed. Analysis was performed using mixed model analysis of covariance (ANCOVA) with fixed effects of treatment, period, participant-level BL, period level BL, country, sex, and age. Change from BL was calculated as the value on Day 29 minus the BL value.||Percent change||Standard Error|Least Squares Mean
818682|NCT01128569|Primary|Weighted Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Between 0–2 Hours, Following the 22–23 Hour Post-treatment Allergen Challenge on Day 29 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants (par.) were exposed to an allergen (administered by inhalation) 22-23 hours after dosing on Day 28. FEV1 was measured 5 minutes (min), 10 min, 15 min, 20 min, 30 min, and 45 min and 1 hour, 1.5 hours, and 2 hours post-allergen challenge on Day 29. Immediately prior to the exposure of allergen and starting at 2 minutes after inhalation of saline, 3 single measurements of FEV1 were recorded at 1-minute intervals, and the best was taken as the post-saline value. The FEV1 weighted mean was derived by calculating the area under the curve, and then dividing the value by the relevant time interval. Weighted mean change from Baseline is calculated as the weighted mean FEV1 value on Day 29 minus the Baseline value. The Baseline FEV1 value was the post-saline value on Day 29.|Baseline and Day 29 of each treatment period (up to Study Day 197)|Intent-to-Treat (ITT) Population: par. randomized to treatment who received >=1 dose of study drug. Only those par. available at the specified time points were analyzed. Analysis was performed using mixed model analysis of covariance (ANCOVA) with fixed effects of treatment, period, par.-level Baseline, period level Baseline, country, sex, and age.||Liters||Standard Error|Least Squares Mean
818683|NCT01128595|Primary|EAR: Absolute Change From Saline in Weighted Mean FEV1 Between 0-2 Hrs Following the 1-hr Post-treatment Allergen Challenge on Day 21 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 1 hr after dosing on Day 21. The EAR FEV1 was measured 0 minutes (min), 5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 hr, 1.5 hrs, and 2 hrs post-allergen challenge on Day 21. Least squares means were obtained by adjusting for period and participant and period Baselines. Absolute change from saline in WM FEV1 was calculated as the area under the curve divided by the relevant time interval and subtracting the saline FEV1 value. After inhalation of saline, 3 single measurements of FEV1 were recorded; the maximum FEV1 value was taken as the saline value.|Day 21 of each treatment period (up to Study Day 197)|Efficacy Population. Only those participants available at the specified time points were analyzed.||Liters||95% Confidence Interval|Least Squares Mean
818684|NCT01128595|Primary|Early Asthmatic Response (EAR): Absolute Change From Saline in Minimum FEV1 Between 0-2 Hrs Following the 1-hr Post-treatment Allergen Challenge on Day 21 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 1 hr after dosing on Day 21. Minimum FEV1 over 0-2 hrs post-allergen challenge (Minimum EAR) is the minimum value of all of the post-allergen challenge timepoints up to and including 2 hours post-allergen challenge (i.e., minimum over 5 minutes (min), 10 min, 15 min, 20 min, 30 min, 45 min and 1 hr, 1.5 hrs, and 2 hrs. Absolute change from saline in minimum FEV1 was calculated as the minimum FEV1 minus the saline FEV1 value. After inhalation of saline, 3 single measurements of FEV1 were recorded; the maximum FEV1 value was taken as the saline value. Least squares means were obtained by adjusting for period and participant and period Baselines.|Day 21 of each treatment period (up to Study Day 197)|Efficacy Population. Only those participants available at the specified time points were analyzed.||Liters||95% Confidence Interval|Least Squares Mean
818747|NCT01121913|Primary|Bioequivalence Based on Cmax|Cmax = Maximum plasma concentration. Measured in nanogram per milliliter (ng/mL).|72 hours|The dataset for pharmacokinetic analysis comprised the 19 subjects who completed the study as per protocol.||ng/mL||Standard Deviation|Mean
818748|NCT01121913|Primary|Bioequivalence Based on AUC(0-∞)|"AUC(0-∞) = Area under the plasma concentration curve vs time data pairs, with extrapolation to infinity (∞).
Measured in nanogram x hours per milliliter (ng*h/mL)."|72 hours|The dataset for pharmacokinetic analysis comprised the 19 subjects who completed the study as per protocol.||ng*h/mL||Standard Deviation|Mean
818685|NCT01128595|Primary|LAR: Absolute Change From Saline in Weighted Mean (WM) FEV1 Between 4-10 Hrs Following the 1-hr Post-treatment Allergen Challenge on Day 21 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 1 hour after dosing on Day 21. LAR FEV1 was measured 4 hrs, 4.5 hrs, 5 hrs, 5.5 hrs, 6 hrs, 6.5 hrs, 7 hrs, 7.5 hrs, 8 hrs, 8.5 hrs, 9 hrs, 9.5 hrs, and 10 hrs post-allergen challenge on Day 21. Absolute change from saline in WM FEV1 was calculated as the area under the curve divided by the relevant time interval and subtracting the saline FEV1 value. After inhalation of saline, 3 single measurements of FEV1 were recorded; the maximum FEV1 value was taken as the saline value. Least squares means were obtained by adjusting for period and participant and period Baselines.|Day 21 of each treatment period (up to Study Day 197)|Efficacy Population. Only those participants available at the specified time points were analyzed.||Liters||95% Confidence Interval|Least Squares Mean
818686|NCT01128595|Secondary|Provocative Concentration of Methacholine Estimated to Result in a 20% Reduction in FEV1 (PC20) on Day 22 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants inhaled doubling increments of methacholine until a >=20% fall in FEV1 from the saline value was achieved. After inhalation of saline, 3 measurements of FEV1 were recorded; the maximum FEV1 value was taken as the saline value.|Day 22 of each treatment period (up to Study Day 198)|Efficacy Population. Only those participants available at the specified time points were analyzed.||milligrams per milliliter||Standard Deviation|Mean
818687|NCT01128595|Secondary|Maximum Percent Change From Saline in FEV1 Between 0-2 Hrs, Following the 1-hr Post-treatment Allergen Challenge on Day 21 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 1 hr after dosing on Day 21. FEV1 was measured 0 minutes (min), 5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 hr, 1.5 hrs, and 2 hrs post-allergen challenge on Day 21. Maximum percent change was calculated as the minimum FEV1 minus the saline FEV1 value divided by the saline FEV1 multiplied by 100. After inhalation of saline, 3 single measurements of FEV1 were recorded; the maximum FEV1 value was taken as the saline FEV1 value.|Day 21 of each treatment period (up to Study Day 197)|Efficacy Population. Only those participants available at the specified time points were analyzed.||percent change||Full Range|Median
818688|NCT01128595|Primary|Late Asthmatic Response (LAR): Absolute Change From Saline in Minimum FEV1 Between 4-10 Hours (Hrs) Following the 1-hr Post-treatment Allergen Challenge on Day 21 of Each Treatment Period|Forced expiratory volume in one second (FEV1) is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen (administered by inhalation) 1 hr after dosing on Day 21. Minimum FEV1 over 4-10 hours post-allergen challenge (minimum LAR) is the minimum value of all of the post-saline time points between 4 and 10 hrs post-allergen challenge, inclusive of the 4 hr and 10 hr timepoints (i.e., minimum over 4 hrs, 4.5 hrs, 5 hrs, 5.5 hrs, 6 hrs, 6.5 hrs, 7 hrs, 7.5 hrs, 8 hrs, 8.5 hrs, 9 hrs, 9.5 hrs, and 10 hrs). Absolute change from saline in minimum FEV1 was calculated as the minimum FEV1 minus the saline FEV1 value. After inhalation of saline, 3 single measurements of FEV1 were recorded; the maximum FEV1 value was taken as the saline value. Least squares means were obtained by adjusting for period and participant and period Baselines.|Day 21 of each treatment period (up to Study Day 197)|Efficacy Population: all participants who received at least one dose of study medication, had a post-dose FEV1 assessment, and who were not major protocol violators. Only those participants available at the specified time points were analyzed.||Liters||95% Confidence Interval|Least Squares Mean
818689|NCT01128738|Secondary|Duration of Effect|Duration of effect is defined as the number of days between the date of first treatment and the date of the first recording of >50% production in gravimetric assessment compared to Baseline.|Up to Week 40|FAS1||days||95% Confidence Interval|Median
818690|NCT01128738|Secondary|Participant's Global Assessment of Treatment Satisfaction in the Second Treatment Phase|Participant's global assessment of treatment satisfaction is a method used to evaluate a participant's treatment satisfaction. Participants rated any improvement or worsening of their symptoms compared to Baseline by using the following 9-point scale: +4, Complete abolishment of signs and symptoms; +3, Marked improvement; +2, Moderate improvement; +1, Slight improvement; 0, Unchanged; -1, Slight worsening; -2, Moderate worsening; -3, Marked worsening; and -4, Very marked worsening.|Weeks 4 (Study Week 20 to Week 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.||scores on a scale||Standard Deviation|Mean
818691|NCT01128738|Secondary|Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 10, participants were asked how much of a problem the treatment for their skin was, for example, by making their home messy, or by taking up time. The Score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 10 is in the Work and School domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.||scores on a scale||Standard Deviation|Mean
818712|NCT01128738|Secondary|Percentage of Responders Assessed by Gravimetric Measurement at Weeks 4, 8, 12, and 16 in the Second Treatment Phase|A pre-weighed filter paper was placed into the axilla area to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced. A responder was defined as a participant showing at least a 50% reduction from Baseline (Week 0 in the Second Treatment Phase) in mean weight of axillary sweating.|Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), and 16 (Study Week 32 to 40) in the Second Treatment Phase|FAS for the Second Treatment Phase (FAS2) (LOCF dataset): all participants who were included in the FAS1, received the second treatment of IP, and had at least one efficacy assessment after the second treatment. One participant who started the Second Treatment Phase was not included in the FAS2 because they had no efficacy assessment in this phase.||percentage of participants|||Number
818692|NCT01128738|Secondary|Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 9, participants were asked how much their skin caused any sexual difficulties over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 9 is in the Personal Relationships domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.||scores on a scale||Standard Deviation|Mean
818693|NCT01128738|Secondary|Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 8, participants were asked how much their skin created problems with their partner or any of their close friends or relatives over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 8 is in the Personal Relationships domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.||scores on a scale||Standard Deviation|Mean
818694|NCT01128738|Secondary|Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 7, participants were asked if their skin prevented them from working or studying over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (yes). Item 7 is in the Work and School domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.||scores on a scale||Standard Deviation|Mean
818695|NCT01128738|Secondary|Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 6, participants were asked how much their skin made it difficult to do any sports over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 6 is in the Leisure domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.||scores on a scale||Standard Deviation|Mean
818696|NCT01128738|Secondary|Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 5, participants were asked how much their skin affected any social or leisure activities over the last week. The Score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 5 is in the Leisure domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.||scores on a scale||Standard Deviation|Mean
818697|NCT01128738|Secondary|Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 4, participants were asked how much their skin interfered with the clothes they wore over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 4 is in the Daily Activities domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.||scores on a scale||Standard Deviation|Mean
818713|NCT01128738|Secondary|Participant's Global Assessment of Treatment Satisfaction in the First Treatment Phase|The participant's global assessment of treatment satisfaction is a method used to evaluate a participant's treatment satisfaction. Participants rated any improvement or worsening of their symptoms compared to Baseline by using the following 9-point scale: +4, Complete abolishment of signs and symptoms; +3, Marked improvement; +2, Moderate improvement; +1, Slight improvement; 0, Unchanged; -1, Slight worsening; -2, Moderate worsening; -3, Marked worsening; and -4, Very marked worsening.|Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.||scores on a scale||Standard Deviation|Mean
818698|NCT01128738|Secondary|Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 3, participants were asked how much their skin interfered with them going shopping or looking after their home or garden over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 3 is in the Daily Activities domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.||scores on a scale||Standard Deviation|Mean
818699|NCT01128738|Secondary|Mean Change From Baseline in the Item 2 (Embarrassed or Self-conscious) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 2, participants were asked how embarrassed or self conscious they were because of their skin over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 2 is in the Symptoms and Feelings domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.||scores on a scale||Standard Deviation|Mean
818700|NCT01128738|Secondary|Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 1, participants were asked how itchy, sore, painful or stinging their skin was over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 1 is in the Symptoms and Feelings domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.||scores on a scale||Standard Deviation|Mean
818701|NCT01128738|Secondary|Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Treatment domain consists of 1 question (Item 10). The score for this item ranges from 0 (not at all or not applicable) to 3 (very much); therefore, the total possible score for the Treatment domain is 0 to 3. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.||scores on a scale||Standard Deviation|Mean
818702|NCT01128738|Secondary|Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Personal Relationships domain consists of 2 questions (Item 8 and Item 9). Scores range from 0 (not at all or not applicable) to 3 (very much) for each item; therefore, the possible total score for the Personal Relationships domain is 0 to 6. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.||scores on a scale||Standard Deviation|Mean
818703|NCT01128738|Secondary|Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Work and School domain consists of 1 question (Item 7). The score for this item ranges from 0 (not at all or not applicable) to 3 (yes); therefore, the possible total score for the Work and School domain is 0 to 3. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.||scores on a scale||Standard Deviation|Mean
818704|NCT01128738|Secondary|Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Leisure domain consists of 2 questions (Item 5 and Item 6). Scores range from 0 (not at all or not applicable) to 3 (very much) for each item; therefore, the possible total score for the Leisure domain is 0 to 6. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.||scores on a scale||Standard Deviation|Mean
818705|NCT01128738|Secondary|Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Daily Activities domain consists of 2 questions (Item 3 and Item 4). Scores range from 0 (not at all or not applicable) to 3 (very much) for each item; therefore, the possible total score for the Daily Activities domain is 0 to 6. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.||scores on a scale||Standard Deviation|Mean
818706|NCT01128738|Secondary|Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Symptoms and Feelings domain consists of 2 questions (Item 1 and Item 2). Scores range from 0 (not at all or not applicable) to 3 (very much) for each item; therefore, the possible total score for the Symptoms and Feelings domain is 0 to 6. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.||scores on a scale||Standard Deviation|Mean
818707|NCT01128738|Secondary|Mean Change From Baseline in the Total Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase|The DLQI is a dermatology-specific, participant-answered questionnaire that allows for comparison of Quality of Life (QOL). DLQI total score (0-30) is a sum of the scores of 6 domains: Symptoms and Feelings, Daily Activities, Leisure, and Personal Relationships (score=0-6 for each); Work and School, and Treatment (score=0-3 for both; 0=not at all or not applicable, 3=very much or yes only in one item of Work and School). A lower score indicates better condition. Change from Baseline in the DLQI total score was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.||scores on a scale||Standard Deviation|Mean
818708|NCT01128738|Secondary|Mean Change From Baseline in the HDSS at Weeks 4, 8, 12, 16, 20 and 24 in the Second Treatment Phase|The HDSS is a 4-point scale (score range: 1-4) used to assess the impact of disease and the clinical relevance of treatment. Participants selected their underarm sweat condition from the following: 1=Never noticeable and never interferes with my daily activities, 2=Tolerable but sometimes interferes with my daily activities, 3=Barely tolerable and frequently interferes with my daily activities, and 4=Intolerable and always interferes with my daily activities. Change from Baseline in HDSS was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.||scores on a scale||Standard Deviation|Mean
818709|NCT01128738|Secondary|Percentage of Responders Assessed by the HDSS in the Second Treatment Phase|The HDSS is a 4-point scale (score range: 1-4) used to assess the impact of disease and the clinical relevance of treatment. Participants selected their underarm sweat condition from the following: 1=Never noticeable and never interferes with my daily activities, 2=Tolerable but sometimes interferes with my daily activities, 3=Barely tolerable and frequently interferes with my daily activities, and 4=Intolerable and always interferes with my daily activities. A responder was defined as a participant whose change from Baseline (Week 0 in the Second Treatment Phase) was equal to or less than -2.|Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.||percentage of participants|||Number
818710|NCT01128738|Secondary|Mean Percent Change From Baseline in Mean Weight of Axillary Sweating at Weeks 4, 8, 12, and 16 in the Second Treatment Phase|A pre-weighed filter paper was placed into the axilla area to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced. Percent change from Baseline in the Second Treatment phase was calculated as follows: (mean weight at each visit minus mean weight at Baseline in the Second Treatment Phase) * 100/mean weight at Baseline in the Second Treatment Phase.|Baseline (Week 0); and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), and 16 (Study Week 32 to 40) in the Second Treatment Phase|||percent change||Standard Deviation|Mean
818711|NCT01128738|Secondary|Mean Weight of Axillary Sweating by Gravimetric Measurement at Baseline and Weeks 4, 8, 12, and 16 in the Second Treatment Phase|A pre-weighed filter paper was placed into the axilla area to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced.|Baseline (Week 0); Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), and 16 (Study Week 32 to 40) in the Second Treatment Phase|FAS2 (LOCF dataset)||mg||Standard Deviation|Mean
818736|NCT01128738|Primary|Percentage of Responders Assessed by Gravimetric Measurement at Week 4 in the First Treatment Phase|A pre-weighed filter paper was placed into the axilla area to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced. A responder was defined as a participant showing at least a 50% reduction from Baseline in mean weight of axillary sweating.|Week 4|Full Analysis Set for the First Treatment Phase (FAS1): all participants who received the first treatment of investigational product (IP) and had at least 1 post-Baseline efficacy assessment. The analysis was performed using the Last Observation Carried Forward (LOCF) dataset; missing data were imputed by carrying forward the last available data.||percentage of participants|||Number
818714|NCT01128738|Secondary|Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 10, participants were asked how much of a problem the treatment for their skin was, for example, by making their home messy, or by taking up time. The Score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 10 is in the Work and School domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.||scores on a scale||Standard Deviation|Mean
818715|NCT01128738|Secondary|Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40 in the First Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 9, participants were asked how much their skin caused any sexual difficulties over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 9 is in the Personal Relationships domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.||scores on a scale||Standard Deviation|Mean
818716|NCT01128738|Secondary|Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 8, participants were asked how much their skin created problems with their partner or any of their close friends or relatives over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 8 is in the Personal Relationships domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.||scores on a scale||Standard Deviation|Mean
818717|NCT01128738|Secondary|Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 7, participants were asked if their skin prevented them from working or studying over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (yes). Item 7 is in the Work and School domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1 The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.||scores on a scale||Standard Deviation|Mean
818718|NCT01128738|Secondary|Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 6, participants were asked how much their skin made it difficult to do any sports over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 6 is in the Leisure domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.||scores on a scale||Standard Deviation|Mean
818719|NCT01128738|Secondary|Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 5, participants were asked how much their skin affected any social or leisure activities over the last week. The Score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 5 is in the Leisure domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.||scores on a scale||Standard Deviation|Mean
818720|NCT01128738|Secondary|Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 4, participants were asked how much their skin interfered with the clothes they wore over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 4 is in the Daily Activities domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.||scores on a scale||Standard Deviation|Mean
818737|NCT01121900|Secondary|Apparent Terminal Half-life (t½.z)|The elimination half-life (T½z) of trazodone in plasma (time it takes for the concentration of trazodone to fall to half), expressed in hours.|68 hours|The dataset for pharmacokinetic analysis comprised the 23 subjects who completed the study as per protocol.||Hours||Standard Deviation|Mean
818721|NCT01128738|Secondary|Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 3, participants were asked how much their skin interfered with them going shopping or looking after their home or garden over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 3 is in the Daily Activities domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.||scores on a scale||Standard Deviation|Mean
818722|NCT01128738|Secondary|Mean Change From Baseline in the Item 2 (Embarrassed or Self-Conscious) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 2, participants were asked how embarrassed or self conscious they were because of their skin over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 2 is in the Symptoms and Feelings domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.||scores on a scale||Standard Deviation|Mean
818723|NCT01128738|Secondary|Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 1, participants were asked how itchy, sore, painful or stinging their skin was over the last week. The scores for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 1 is in the Symptoms and Feelings domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.||scores on a scale||Standard Deviation|Mean
818724|NCT01128738|Secondary|Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Treatment domain consists of 1 question (Item 10). The score for this item ranges from 0 (not at all or not applicable) to 3 (very much); therefore, the total possible score for the Treatment domain is 0 to 3. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.||scores on a scale||Standard Deviation|Mean
818725|NCT01128738|Secondary|Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Personal Relationships domain consists of 2 questions (Item 8 and Item 9). Scores range from 0 (not at all or not applicable) to 3 (very much) for each item; therefore, the possible total score for the Personal Relationships domain is 0 to 6. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.||scores on a scale||Standard Deviation|Mean
818726|NCT01128738|Secondary|Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Work and School domain consists of 1 question (Item 7). The score for this item ranges from 0 (not at all or not applicable) to 3 (yes); therefore, the possible total score for the Work and School domain is 0 to 3. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.||scores on a scale||Standard Deviation|Mean
818727|NCT01128738|Secondary|Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Leisure domain consists of 2 questions (Item 5 and Item 6). Scores range from 0 (not at all or not applicable) to 3 (very much) for each item; therefore, the possible total score for the Leisure domain is 0 to 6. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.||scores on a scale||Standard Deviation|Mean
818738|NCT01121900|Secondary|Apparent Terminal Elimination Rate Constant (λz)|The elimination rate constant of trazodone (Lamda z). It is the ratio of clearance to volume of distribution and is expressed in units of 1/hour. This constant is used in half-life calculations.|68 hours|The dataset for pharmacokinetic analysis comprised the 23 subjects who completed the study as per protocol.||1/hour||Standard Deviation|Mean
818728|NCT01128738|Secondary|Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Daily Activities domain consists of 2 questions (Item 3 and Item 4). Scores range from 0 (not at all or not applicable) to 3 (very much) for each item; therefore, the possible total score for the Daily Activities domain is 0 to 6. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.||scores on a scale||Standard Deviation|Mean
818729|NCT01128738|Secondary|Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Symptoms and Feelings domain consists of 2 questions (Item 1 and Item 2). Scores range from 0 (not at all or not applicable) to 3 (very much) for each item; therefore, the possible total score for the Symptoms and Feelings domain is 0 to 6. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.||scores on a scale||Standard Deviation|Mean
818730|NCT01128738|Secondary|Mean Change From Baseline in the Total Score of the Dermatology Life Quality Index (DLQI) at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase|The DLQI is a dermatology-specific, participant-answered questionnaire that allows for comparison of Quality of Life (QOL). DLQI total score (0-30) is a sum of the scores of 6 domains: Symptoms and Feelings, Daily Activities, Leisure, and Personal Relationships (score=0-6 for each); Work and School, and Treatment (score=0-3 for both; 0=not at all or not applicable, 3=very much or yes only in one item of Work and School). A lower score indicates better condition. Change from Baseline in the DLQI total score was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.||scores on a scale||Standard Deviation|Mean
818731|NCT01128738|Secondary|Mean Change From Baseline in HDSS at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase|The HDSS is a 4-point scale (score range: 1-4) used to assess the impact of disease and the clinical relevance of treatment. Participants selected their underarm sweat condition from the following: 1=Never noticeable and never interferes with my daily activities, 2=Tolerable but sometimes interferes with my daily activities, 3=Barely tolerable and frequently interferes with my daily activities, and 4=Intolerable and always interferes with my daily activities. Change from Baseline in HDSS was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.||scores on a scale||Standard Deviation|Mean
818732|NCT01128738|Secondary|Percentage of Responders Assessed by the Hyperhidrosis Severity Scale (HDSS) in the First Treatment Phase|The HDSS is a 4-point scale (score range: 1-4) used to assess the impact of disease and the clinical relevance of treatment. Participants selected their underarm sweat condition from the following: 1=Never noticeable and never interferes with my daily activities, 2=Tolerable but sometimes interferes with my daily activities, 3=Barely tolerable and frequently interferes with my daily activities, and 4=Intolerable and always interferes with my daily activities. A responder was defined as a participant whose change from Baseline was equal to or less than -2.|Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants remaining in the study at the time of the visit, particularly regardless of reinjection after Week 16, was used as the denominator. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.||percentage of participants|||Number
818733|NCT01128738|Secondary|Mean Percent Change From Baseline in Mean Weight of Axillary Sweating at Weeks 1, 4, 8, 12, 16, 20, and 24 in the First Treatment Phase|A pre-weighed filter paper was placed into the axilla area to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced. Percent change from Baseline was calculated as follows: (mean weight at each visit minus mean weight at Baseline) * 100/mean weight at Baseline.|Week 0 (Baseline); and Weeks 1, 4, 8, 12, 16, 20, and 24|FAS1 (LOCF dataset). In the first treatment phase, the imputation of missing data by LOCF was performed up to Week 24; the missing data after Week 24 in the first treatment phase were not imputed.||percent change||Standard Deviation|Mean
818734|NCT01128738|Secondary|Mean Weight of Axillary Sweating by Gravimetric Measurement at Baseline and Weeks 1, 4, 8, 12, 16, 20, and 24 in the First Treatment Phase|A pre-weighed filter paper was placed into the axilla area to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced.|Week 0 (Baseline); Weeks 1, 4, 8, 12, 16, 20, and 24|FAS1 (LOCF dataset). In the first treatment phase, the imputation of missing data by LOCF was performed up to Week 24; the missing data after Week 24 in the first treatment phase were not imputed.||milligrams (mg)||Standard Deviation|Mean
818735|NCT01128738|Secondary|Percentage of Responders Assessed by Gravimetric Measurement at Weeks 1, 8, 12, 16, 20, and 24 in the First Treatment Phase|A pre-weighed filter paper was placed into the axilla area to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced. A responder was defined as a participant showing at least a 50% reduction from Baseline in mean weight of axillary sweating.|Weeks 1, 8 ,12, 16, 20, and 24|FAS1 (LOCF dataset). In the first treatment phase, the imputation of missing data by LOCF was performed up to Week 24; the missing data after Week 24 in the first treatment phase were not imputed.||percentage of participants|||Number
818739|NCT01121900|Secondary|Time to Maximum Plasma Concentration (Tmax)||68 hours|The dataset for pharmacokinetic analysis comprised the 23 subjects who completed the study as per protocol.||Hours||Full Range|Median
818749|NCT01121913|Primary|Bioequivalence Based on AUC(0-t)|"AUC(0-t) = Area under the plasma concentration curve vs (versus) time data pairs, where t is the time of the last quantifiable concentration.
Measured in nanogram x hours per milliliter (ng*h/mL)."|72 hours|The dataset for pharmacokinetic analysis comprised the 19 subjects who completed the study as per protocol.||ng*h/mL||Standard Deviation|Mean
818750|NCT01121926|Secondary|Percentage Peak-Trough Fluctuation (%PTF)|"Percentage Peak-Trough Fluctuation (%PTF) of trazodone calculated as [100*(Cmax-Cmin)/Cav].
Cmax: Maximum plasma concentration Cmin: Minimum plasma concentration Cav: Average plasma concentration"|9 days|The dataset for pharmacokinetic analysis comprised the 27 subjects who completed the study as per protocol.||Percentage Peak-Trough Fluctuation||Standard Deviation|Mean
818751|NCT01121926|Secondary|Percentage Swing|"Percentage swing is a pharmacokinetic parameter calculated as follows:
((Cmax,ss - Cmin,ss)/Cmin,ss)*100.
Where:
Cmax,ss = Maximum concentration at steady state; Cmin,ss = Minimum concentration at steady state.
It was calculated over 24 hours on day 9."|9 days|The dataset for pharmacokinetic analysis comprised the 27 subjects who completed the study as per protocol.||Percentage swing||Standard Deviation|Mean
818752|NCT01121926|Secondary|Time to Peak Exposure (Tmax)|Time to peak exposure (Tmax) at steady state.|9 days|The dataset for pharmacokinetic analysis comprised the 27 subjects who completed the study as per protocol.||hours||Full Range|Median
818753|NCT01121926|Secondary|Plasma Concentration at 24 Hours Post-evening Dose (C24h)|Plasma concentration at 24 hours post-evening dose (C24h) in nanograms per milliliter (ng/mL)|9 days|The dataset for pharmacokinetic analysis comprised the 27 subjects who completed the study as per protocol.||ng/mL||Standard Deviation|Mean
818754|NCT01121926|Secondary|Minimum Plasma Concentration (Cmin,ss)|Minimum plasma concentration at steady state (Cmin,ss). Measured in nanograms per milliliter (ng/mL)|9 days|The dataset for pharmacokinetic analysis comprised the 27 subjects who completed the study as per protocol.||ng/mL||Standard Deviation|Mean
818755|NCT01121926|Primary|Bioequivalence Based on AUCss|"AUCss = Area under the plasma concentration curve (AUC) vs. time data pairs at steady state (ss): AUCss.
Measured in nanograms x hours per milliliter (ng*h/mL)."|9 days|The dataset for pharmacokinetic analysis comprised the 27 subjects who completed the study as per protocol.||ng*h/mL||Standard Deviation|Mean
818756|NCT01121926|Primary|Bioequivalence Based on Cmax,ss|Cmax,ss = Maximum plasma concentration (Cmax) at steady state (ss): (Cmax,ss). Measured in nanograms per milliliter (ng/mL).|9 days|The dataset for pharmacokinetic analysis comprised the 27 subjects who completed the study as per protocol.||ng/mL||Standard Deviation|Mean
818757|NCT01121939|Secondary|Disease Control Rate|The Percentage of Patients Who Experience an Objective Benefit From Treatment or Experience Stable Disease. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), Neither Sufficient Shrinkage to Qualify For PR, Nor Sufficient Increase to Qualify for Progressive Disease; Disease Control Rate = CR + PR + SD.|18 months|Includes all patients||percentage of participants|||Number
818758|NCT01121939|Secondary|Overall Survival (OS)|The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death|18 months|Includes all patients (patients in both the typical carcinoid and pancreatic islet cell groups received the same treatment)||months||95% Confidence Interval|Median
818759|NCT01121939|Secondary|Progression-Free Survival (PFS)|The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|18 months|Includes all patients (patients in both the typical carcinoid and pancreatic islet cell groups received the same treatment)||months||95% Confidence Interval|Median
818760|NCT01121939|Secondary|Define Toxicity and Safety|To define the toxicity and safety of the combination of bevacizumab, pertuzumab and Sandostatin LAR® when used in patients with advanced low grade neuroendocrine cancer - defined by grade 3/4, treatment-related toxicity|18 months|All patients on study||participants|||Number
818761|NCT01121939|Primary|Objective Response Rate (ORR)|The Percentage of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|18 months|Includes all patients||percentage of participants|||Number
818762|NCT01121991|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Study Drug Discontinuation.|AEs: Any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. TEAEs: AEs that occur during treatment with the study drug. It also included incidences of mild, moderate and severe ovarian hyperstimulation syndrome (OHSS). SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued from the study due to AE were also recorded.|From stimulation Day 1 (S1) to post-hCG days 35-42 (safety visit).|ITT population: all participants who received at least one dose of the study drug.||Number of participants|||Number
818763|NCT01121991|Secondary|Pregnancy Loss Per Clinical Pregnancy|Preclinical miscarriage: Spontaneous cessation of a biochemical pregnancy. Early spontaneous abortion: Any spontaneous abortion occurring after confirmation of clinical pregnancy and before completion of 12 weeks of gestation. Late spontaneous abortion: any spontaneous abortion occurring between completion of 12 weeks of gestation and prior to a viable stage. Pregnancy loss per clinical pregnancy was measured as a percentage.|Post-hCG days 35-42.|Participants with confirmed clinical pregnancies.||Percentage of pregnancy loss|||Number
818764|NCT01121991|Secondary|Number of Live Births|A live birth occurs when a fetus, whatever its gestational age, exits the maternal body and subsequently shows any sign of life, such as voluntary movement, heartbeat, or pulsation of the umbilical cord, for however brief a time and regardless of whether the umbilical cord or placenta are intact.|Post-hCG days 15-20 to pregnancy follow up.|ITT population: all participants who received at least one dose of the study drug.||Live births|||Number
818765|NCT01121991|Secondary|Number of Participants With Multiple Pregnancies|Multiple pregnancy is a pregnancy where more than one fetus develops simultaneously in the womb. There are two types of twinning—identical and fraternal. Identical twins represent the splitting of a single fertilized zygote (union of two gametes or male/female sex cells that produce a developing fetus) into two separate individuals.|Post-hCG Day 35-42.|ITT population: all participants who received at least one dose of the study drug.||participants|||Number
818766|NCT01121991|Secondary|Number of Participants With Confirmed Pregnancies: Biochemical Pregnancies and Clinical Pregnancies|Biochemical pregnancy: A positive pregnancy test defined as hCG level >10 IU/L in a sample taken at least 14 days after Day 3 embryo transfer or 12 days after Day 5/6 embryo transfer with no further ultrasound confirmation of the existence of a gestational sac in the uterus. Clinical pregnancy: Existence of at least one ultrasonography confirmed gestational sac in the uterus, with or without heartbeat.|Post-hCG days 15-20 and post-hCG days 35-42.|ITT population: all participants who received at least one dose of the study drug.||participants|||Number
818767|NCT01121991|Secondary|Mean Number of Oocytes Retrieved Per Number of Follicles Aspirated on the Day of Ovum Pick up|Mean number of oocytes retrieved per number of follicles aspirated on the day of ovum pick up was calculated. Oocyte retrieval is a technique used in in vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body.|On day of ovum pick up (Day 1 or 2 after hCG administration)|ITT population: all participants who received at least one dose of the study drug and underwent vaginal ovum pick up.||oocytes per aspirated follicle||Standard Deviation|Mean
818768|NCT01121991|Primary|Mean Number of Mature Oocytes Per Participant Who Underwent Ovum Pick up for In Vitro Fertilization (IVF)|Mean number of oocytes undergoing ovum pick up for IVF were calculated for each participant. IVF is a process by which egg cells are fertilized by sperm outside the body, in-vitro.|On the day of ovum pick up (Day 1 or 2 after hCG administration).|Analysis population includes those participants undergoing IVF whose oocytes were assessed for maturity. Mature oocytes can be considered as Metaphase II oocytes.||oocytes||Standard Deviation|Mean
818769|NCT01121991|Primary|Mean Number of Metaphase II Oocytes Per Participant Who Underwent Ovum Pick up for Intra-cytoplasmic Sperm Injection (ICSI)|Mean number of metaphase II oocytes was calculated for each participant undergoing ovum pick up for ICSI. ICSI is an in-vitro fertilization procedure in which a single sperm is injected directly into an egg under a microscope. Metaphase II stage of the oocyte was classified as the time at which the first polar body was observed microscopically. Metaphase II oocytes are a sub-group of the total number of oocytes.|On the day of ovum pick up (Day 1 or 2 after human chorionic gonadotropin [hCG] administration).|Analysis population includes those participants undergoing ICSI whose oocytes were assessed for maturity (Metaphase II) using a microscope.||Metaphase II Oocytes||Standard Deviation|Mean
818770|NCT01122030|Secondary|Apparent Elimination Half-life of Naldemedine and Metabolite Nor-S-297995|The plasma concentration of naldemedine and its metabolite Nor-S-297995 were measured by liquid chromatography/tandem mass spectrometry (LC/MS/MS) method. The apparent elimination half-life was calculated using the formula t1/2,z = (ln2)/λZ|Blood samples were collected predose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 hours post-dose.|PK population||hours||Geometric Coefficient of Variation|Geometric Mean
818771|NCT01122030|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity for Naldemedine and Metabolite Nor-S-297995|The plasma concentration of naldemedine and its metabolite Nor-S-297995 were measured by liquid chromatography/tandem mass spectrometry (LC/MS/MS) method. Area under the plasma concentration versus time curve from time zero to infinity, calculated using the formula: AUC0-inf = AUC0-t + Ct/λZ where Ct was the last measurable concentration and λZ was the apparent terminal elimination rate constant.|Blood samples were collected predose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 hours post-dose.|PK population||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
818772|NCT01122030|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Measurable Concentration of Naldemedine and Metabolite Nor-S-297995|The plasma concentration of naldemedine and its metabolite Nor-S-297995 were measured by liquid chromatography/tandem mass spectrometry (LC/MS/MS) method. Area under the plasma concentration versus time curve from time zero to the last sampling time at which concentrations were at or above the limit of quantitation, calculated using the linear trapezoidal rule for increasing concentrations and the logarithmic rule for decreasing concentrations (Linear Up/ Log Down).|Blood samples were collected predose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 hours post-dose.|PK population||ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
818773|NCT01122030|Secondary|Time to Maximum Observed Plasma Concentration of Naldemedine and Metabolite Nor-S-297995|The plasma concentration of naldemedine and its metabolite Nor-S-297995 were measured by liquid chromatography/tandem mass spectrometry (LC/MS/MS) method.|Blood samples were collected predose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 hours post-dose.|PK population||hours||Full Range|Median
818774|NCT01122030|Secondary|Maximum Observed Plasma Concentration (Cmax) of Naldemedine and Metabolite Nor-S-297995|The plasma concentration of naldemedine and its metabolite Nor-S-297995 were measured by liquid chromatography/tandem mass spectrometry (LC/MS/MS) method.|Blood samples were collected predose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 hours post-dose.|The pharmacokinetic (PK) analysis population included all randomized participants who received study drug and had at least one post-dose PK assessment completed.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
818775|NCT01122030|Secondary|Percentage of Participants With Webster Opiate Withdrawal Scale (WOWS) Score > 8 at Any Time During the Study|The Webster Opiate Withdrawal Scale (WOWS) assessment consisted of 7 questions which rate the severity of opiate withdrawal symptoms, including sweating, sleep, bone or joint aches, runny nose or tearing, gastrointestinal upset, anxiety or irritability and gooseflesh skin. Each symptom was rated on a scale from 0 (not present/no issues) to 4 or 5 (severe). The total score was calculated by summing the 7 individual scores and ranged from 0 (no withdrawal symptoms) to 29 (worst symptoms).|The WOWS assessment was performed at Screening, Day 14, Day 15 at pre-dose , and 24 and 48 hours post-dose and at the Follow-up/End of Study visit (Day 24).|Safety population||percentage of participants||95% Confidence Interval|Number
818830|NCT01122576|Secondary|Uncorrected Distance Visual Acuity|High Contrast Uncorrected Distance (UCDVA) measured at 32 inches, Intermediate (UCIVA) at 32 inches, and Near Visual Acuity (UCNVA) at 16 inches|Visit 3 (2-3 months) Visit 4 (4-6 months)|Full Analysis Set||logMAR|Participants|Standard Deviation|Mean
818776|NCT01122030|Secondary|Percentage of Participants With Clinical Opiate Withdrawal Scale (COWS) Score > 8 at Any Time During the Study|The COWS assessment consisted of 11 questions which rated the severity of opiate withdrawal symptoms, including resting pulse rate, gastrointestinal upset, sweating, restlessness, pupil size, tremor, anxiety or irritability, bone or joint aches, gooseflesh skin, yawning, and runny nose or tearing. Each symptom was rated on a scale from 0 (not present) to 4 or 5 (most severe). The total score was calculated by summing the 11 individual scores and ranged from 0 (no withdrawal symptoms) to 48 (worst symptoms).|The COWS assessments were performed at Screening, on Day 14, Day 15 (pre-dose and 1, 2, 3, 4, 5, 6 and 8 hours post-dose, and at unscheduled times as signs or symptoms indicate), on Days 16 and 17, and on Day 24/End of Study.|Safety population||percentage of participants||95% Confidence Interval|Number
818777|NCT01122030|Secondary|Change From Baseline in Number of Rescue Medications Used Per Day|Baseline was defined as the average number of rescue medications used per day prior to receiving study drug (Day 1 to Day 15). The number of rescue medications used per day at 24 hours and 48 hours post-dose was calculated as the average number of rescue medications used per day from 0 to 24 hours and 0 to 48 hours post-dose, respectively.|Baseline, 24 hours post-dose and 48 hours post-dose|Intent-to-treat population; LOCF imputation was used||rescue medications / day||Standard Deviation|Mean
818778|NCT01122030|Secondary|Change From Baseline in the Number of Bowel Movements With No Straining Per Day|"Straining during BMs was graded using the following scale:
0 = Absent; 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Very Severe. A BM without straining was defined as a BM with a straining score = 0.
Baseline was defined as the average number of BMs without straining per day prior to receiving study drug (Day 1 to Day 15). The number of BMs without straining per day at 24 hours and 48 hours post-dose was calculated as the average number of BMs with no straining per day from 0 to 24 hours and 0 to 48 hours post-dose, respectively."|Baseline, 24 hours post-dose and 48 hours post-dose|Intent-to-treat population; LOCF imputation was used||bowel movements with no straining / day||Standard Deviation|Mean
818779|NCT01122030|Secondary|Change From Baseline in Number of False Start Bowel Movements Per Day|"A false start was defined as any attempted, but unsuccessful bowel movement (no solid or liquid fecal material was excreted) based on the question “In the past 24 hours, how many times did you try to have a bowel movement but were unsuccessful? Baseline was defined as the average number of false start BMs per day prior to receiving study drug (Day 1 to Day 15).
The number of false start BMs per day at 24 hours and 48 hours post-dose was calculated as is the average number of false start BMs per day from 0 to 24 and 0 to 48 hours post-dose, respectively."|Baseline, 24 hours post-dose and 48 hours post-dose|Intent-to-treat population; LOCF imputation was used||false start bowel movements / day||Standard Deviation|Mean
818780|NCT01122030|Secondary|Change From Baseline in BM Consistency|"Consistency of BMs was measured using the Bristol Stool Scale, as follows:
1 = separate hard lumps like nuts; 2 = sausage shaped but lumpy; 3 = like a sausage, but with cracks on its surface; 4 = like a sausage or a snake, smooth and soft; 5 = soft blobs and with clear-cut edges; 6 = floppy pieces with ragged edges/mushy stool; 7 = watery, no solid pieces, entirely liquid.
Baseline was defined as the average consistency of BMs prior to receiving study drug (Day 1 to Day 15). BM consistency at 24 hours and 48 hours post-dose was calculated as the average scores from all bowel movements from 0 to 24 and 0 to 48 hours post-dose, respectively."|Baseline, 24 hours post-dose and 48 hours post-dose|Intent-to-treat population with available data at each time point.||units on a scale||Standard Deviation|Mean
818781|NCT01122030|Secondary|Change From Baseline in Abdominal Discomfort|"Participants were asked to rate their abdominal discomfort for the past 24 hours using the following scale:
0 = Absent; 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Very Severe. Baseline was defined as the average abdominal discomfort score prior to receiving study drug (Day 1 to Day 15). Abdominal discomfort at 24 hours and 48 hours post-dose was calculated as the mean score from 0 to 24 and 0 to 48 hours post-dose respectively."|Baseline, 24 hours post-dose and 48 hours post-dose|Intent-to-treat population with available data at each time point.||units on a scale||Standard Deviation|Mean
818782|NCT01122030|Secondary|Change From Baseline in Abdominal Bloating|"Participants were asked to rate their abdominal bloating for the past 24 hours using the following scale:
0 = Absent; 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Very Severe. Baseline was defined as the average abdominal bloating score prior to receiving study drug (Day 1 to Day 15). Abdominal bloating at 24 hours and 48 hours post-dose was calculated as the mean score from 0 to 24 and 0 to 48 hours post-dose respectively."|Baseline, 24 hours post-dose and 48 hours post-dose|Intent-to-treat population with available data at each time point.||units on a scale||Standard Deviation|Mean
818783|NCT01122030|Secondary|Change From Baseline to 48 Hours Post-dose in Number of Complete Bowel Movements Per Day|A complete bowel movement (CBM) was defined as a bowel movement that resulted in a sensation of complete evacuation based on the question “Did you have a feeling of complete emptying after the bowel movement?” Baseline was defined as the average number of CBMs per day prior to receiving study drug (Day 1 to 15). Forty-eight hours post-dose was calculated as the average number of CBMs per day from 0 to 48 hours post-dose.|Baseline and 48 hours post-dose|Intent-to-treat population; LOCF imputation was used||complete bowel movements / day||Standard Deviation|Mean
818784|NCT01122030|Secondary|Change From Baseline to 24 Hours Post-dose in Number of Complete Bowel Movements Per Day|A complete bowel movement (CBM) was defined as a bowel movement that resulted in a sensation of complete evacuation based on the question “Did you have a feeling of complete emptying after the bowel movement?” Baseline was defined as the average number of CBMs per day prior to receiving study drug (Day 1 to Day 15).|Baseline and 24 hours post-dose|Intent-to-treat population; LOCF imputation was used||complete bowel movements / day||Standard Deviation|Mean
818785|NCT01122030|Secondary|Change From Baseline in Straining During Bowel Movements|"Straining during BMs was graded using the following scale: 0 = Absent; 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Very Severe.
Baseline was defined as the average straining score of all BMs prior to receiving study drug (Day 1 to Day 15). The straining score at 24 and 48 hours post-dose was calculated as the average straining score from all bowel movements from 0 to 24 and 0 to 48 hours post-dose, respectively."|Baseline, 24 hours post-dose and 48 hours post-dose|Intent-to-treat population with available data at each time point||units on a scale||Standard Deviation|Mean
818831|NCT01122576|Secondary|Manifest Refraction|Manifest refraction spherical equivalent (MRSE) was calculated as the value of the sphere plus one-half of the value of the cylinder.|Visit 4 (4-6 Months)|Full Analysis Set||Diopters|Participants|Standard Deviation|Mean
818786|NCT01122030|Secondary|Time to First Complete Spontaneous Bowel Movement|The time to first CSBM during the Study Drug Administration Period was summarized using Kaplan-Meier estimates. Each participant’s first CSBM was counted as an event and the time to first CSBM after dosing was calculated from the date and time of first dosing until the date and time of first CSBM. Participants who dropped out or were lost to follow-up before the first CSBM were censored.|From first dose on Day 15 through Day 17|Intent-to-treat population||hours||95% Confidence Interval|Median
818787|NCT01122030|Secondary|Time to First Bowel Movement|The time to first BM during the Study Drug Administration Period was summarized using Kaplan-Meier estimates. Each participant’s first BM was counted as an event and the time to first BM after dosing was calculated from the date and time of first dosing until the date and time of first BM. Participants who dropped out or were lost to follow-up before the first BM were censored.|From first dose on Day 15 through Day 17|Intent-to-treat population||hours||95% Confidence Interval|Median
818788|NCT01122030|Secondary|Time to First Spontaneous Bowel Movement|The time to first SBM during the Study Drug Administration Period was summarized using Kaplan-Meier estimates. Each participant’s first SBM was counted as an event and the time to first SBM after dosing was calculated from the date and time of first dosing until the date and time of first SBM. Participants who dropped out or were lost to follow-up before the first SBM were censored.|From first dose on Day 15 through Day 17|Intent-to-treat population||hours||95% Confidence Interval|Median
818789|NCT01122030|Secondary|Change From Baseline to 48 Hours Post-dose in Number of Complete Spontaneous Bowel Movements (CSBMs) Per Day|"Participants completed a bowel function assessment daily diary to record information about bowel movements and constipation. A complete spontaneous bowel movement was defined as a bowel movement where no laxative or enema was used and the bowel movement resulted in a sensation of complete evacuation (based on the question of “having a feeling of complete emptying after the bowel movement”).
Baseline was defined as the average number of CSBMs per day during the 2 weeks prior to receiving study drug (Day 1 to Day 15). Forty-eight hours post-dose was defined as the average number of CSBMs per day from 0 to 48 hours post-dose."|Baseline and 48 hours post-dose|Intent-to-treat population; LOCF imputation was used||complete spontaneous bowel movements/day||Standard Deviation|Mean
818790|NCT01122030|Secondary|Change From Baseline to 24 Hours Post-dose in Number of Complete Spontaneous Bowel Movements (CSBMs) Per Day|"Participants completed a bowel function assessment daily diary to record information about bowel movements and constipation. A complete spontaneous bowel movement was defined as a bowel movement where no laxative or enema was used and the bowel movement resulted in a sensation of complete evacuation (based on the question of “having a feeling of complete emptying after the bowel movement”).
Baseline was defined as the average number of CSBMs per day during the 2 weeks prior to receiving study drug (Day 1 to Day 15)."|Baseline and 24 hours post-dose|Intent-to-treat population; LOCF imputation was used||complete spontaneous bowel movements/day||Standard Deviation|Mean
818791|NCT01122030|Secondary|Change From Baseline to 48 Hours Post-dose in Number of Bowel Movements Per Day|Participants completed a bowel function assessment daily diary to record information about bowel movements and constipation. Baseline was defined as the average number of BMs per day during the 2 weeks prior to receiving study drug (Day 1 to Day 15). Forty-eight hours post-dose was defined as the average number of BMs per day from 0 to 48 hours post-dose.|Baseline and 48 hours post-dose|Intent-to-treat population; LOCF imputation was used||bowel movements / day||Standard Deviation|Mean
818792|NCT01122030|Secondary|Change From Baseline to 24 Hours Post-dose in Number of Bowel Movements (BM) Per Day|Participants completed a bowel function assessment daily diary to record information about bowel movements and constipation. Baseline was defined as the average number of BMs per day during the 2 weeks prior to receiving study drug (Day 1 to Day 15).|Baseline and 24 hours post-dose|Intent-to-treat; LOCF imputation was used||bowel movements / day||Standard Deviation|Mean
818793|NCT01122030|Secondary|Change From Baseline to 48 Hours Post-dose in the Number of SBMs Per Day|Participants completed a bowel function assessment daily diary to record information about bowel movements and constipation. A spontaneous bowel movement was defined as a bowel movement where no laxative or enema was used in the 24 hours preceding the bowel movement. Baseline was defined as the average number of SBMs per day during the 2 weeks prior to receiving study drug (Day 1 to Day 15). Forty-eight hours post-dose was defined as the average number of SBMs per day from 0 to 48 hours post-dose.|Baseline (Day 1 to Day 15) and Day 15 to Day 17 (0 to 48 hours post-dose)|Intent-to-treat population; LOCF imputation was used||Spontaneous bowel movements / day||Standard Deviation|Mean
818794|NCT01122030|Secondary|Change From Baseline to 24 Hours Post-dose in Number of Spontaneous Bowel Movements (SBMs) Per Day|"Participants completed a bowel function assessment daily diary to record information about bowel movements and constipation. A spontaneous bowel movement was defined as a bowel movement where no laxative or enema was used in the 24 hours preceding the bowel movement.
Baseline was defined as the average number of SBMs per day during the 2 weeks prior to receiving study drug (Day 1 to Day 15)."|Baseline (Day 1 to Day 15) and Day 15 to 16 (0 to 24 hours post-dose)|All randomized participants who received study drug and had at least 1 post-dose efficacy assessment completed (intent-to-treat population). Last observation carried forward (LOCF) imputation was used.||spontaneous bowel movements / day||Standard Deviation|Mean
818795|NCT01122030|Primary|Number of Participants With Adverse Events|"Severity of adverse events (AEs) was graded according to the following definitions:
Mild: The subject experiences awareness of symptoms but these are easily tolerated or managed without specific treatment
Moderate: The subject experiences discomfort enough to cause interference with usual activity, and/or the condition requires specific treatment
Severe: The subject is incapacitated with inability to work or do usual activity, and/or the event requires significant treatment measures.
The relationship of the event to the study drug was determined by the investigator.
A serious adverse event (SAE) is defined as any AE occurring at any dose that resulted in any of the following outcomes: death, life-threatening AE, hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect."|From the first dose of study drug on Day 15 up to Day 24.|All participants who received any amount of study drug (safety population).||participants|||Number
818796|NCT01122108|Other Pre-specified|Weighted vs. Unweighted Composite BASA Scale Scores|Aggregate scores were calculated for both the unweighted and weighted BASA scale scores for both Colesevlam HCL (3.75G) and Cholestyramine (12g). The best possible total BASA score is 20 and the worst possible total BASA score is 4. For the weighted version of the scale, the best possible total score is 60 and the worst possible total score is 4.|1 Day|||Units on a BASA Scale||Standard Deviation|Mean
818797|NCT01122108|Primary|Patient Acceptability of Colesevelam HCl Powder for Oral Suspension vs. Generic Cholestyramine Via the Bile Acid Sequestrant Acceptability (BASA) Scale, Based Upon an Anticipated Equivalent Cholesterol Lowering Doses of Each Comparator Drug.|The bile acid sequestrant acceptability (BASA) scale has 4 scoring categories: taste, texture, appearance, and mixability. Participants rank each category separately. The best possible score for each category is 5, and the worst possible score for each category is 1.|1 Day|||Units on BASA Scale||Standard Deviation|Mean
818798|NCT01122160|Primary|Gastric pH||1 hour prior to gastric emptying on Day 7 of the given intervention|||pH||Standard Deviation|Mean
818799|NCT01122238|Primary|Percent Change in Cigarettes Smoked Per Day (CPD)|"Percent Change in Cigarettes Smoked Per Day (CPD) is computed as the percent change in self-reported cigarettes smoked per day at the assessment endpoint relative to baseline CPD; this outcome will be analyzed in a linear regression analysis model.
Note: This Percent change in Cigarettes Smoked Per Day (CPD) primary outcome replaces average number of cigarettes per day in the past week (now designated as a secondary outcome) because the percent change metric allows better comparison with prior research in this area and the results for both outcomes are highly similar."|Assessed at week 26 relative to baseline CPD.|Adult smokers not yet motivated to quit smoking. The project design measured change in the smoking patterns of these individuals.||Percent Change in cigarettes per day||Standard Deviation|Mean
818800|NCT01122238|Secondary|Average Number of Cigarettes Per Day in the Past Week.||Assessed at baseline and week 26.|Adult smokers not yet motivated to quit smoking. The project design measured change in the smoking patterns of these individuals.||Change in cigarettes per day||Standard Deviation|Mean
818801|NCT01122264|Secondary|Change From Baseline to 4, 8, 16, and 24 Weeks of the Overall Relationship Domain of the Self-Esteem and Relationship (SEAR) Questionnaire|SEAR assesses psychosocial outcomes in men with erectile dysfunction. The Overall Relationship domain consists of 2 items (items 13-14), each rated on a scale of 1 (Never) to 5 (Always). The domain score was computed by summing its respective items, then transforming it into a 0 (least favorable) to 100 (most favorable) scale. The transformed score = 100 x [(actual raw score - lowest possible raw score)/possible raw score range]. Least Squares Mean changes were adjusted for baseline score, treatment group, country, visit, and visit*treatment.|Baseline, 4, 8, 16, and 24 weeks|The analysis included all randomly assigned participants who had a baseline and post-baseline SEAR Overall Relationship observation.||units on a scale||95% Confidence Interval|Least Squares Mean
818802|NCT01122264|Secondary|Change From Baseline to 4, 8, 16, and 24 Weeks of the Self Esteem Domain of the Self-Esteem and Relationship (SEAR) Questionnaire|SEAR assesses psychosocial outcomes in men with erectile dysfunction. The Self-Esteem domain consists of 4 items (items 9-12), each rated on a scale of 1 (Never) to 5 (Always). Item 11 is reverse scored (1=Always and 5=Never). The domain score was computed by summing its respective items, then transforming it into a 0 (least favorable) to 100 (most favorable) scale. The transformed score = 100 x [(actual raw score - lowest possible raw score)/possible raw score range]. Least Squares Mean changes were adjusted for baseline score, treatment group, country, visit, and visit*treatment.|Baseline, 4, 8, 16, and 24 weeks|The analysis included all randomly assigned participants who had a baseline and post-baseline SEAR Self-Esteem observation.||units on a scale||95% Confidence Interval|Least Squares Mean
818803|NCT01122264|Secondary|Change From Baseline to 4, 8, 16, and 24 Weeks of the Confidence Domain of the Self-Esteem and Relationship (SEAR) Questionnaire|SEAR assesses psychosocial outcomes in men with erectile dysfunction. Confidence domain measures improvement in confidence; 2 subscales (6 items: Self-Esteem [items 9-12]; Overall Relationship [items 13-14]). Each item range: 1 (Never) to 5 (Always); item 11 reverse scored. Domain score=sum of domain's respective items, then transformed into 0 (least favorable) to 100 (most favorable) scale. Transformed score=100x[(actual raw score-lowest possible raw score)/possible raw score range]. Least Squares Mean change adjusted for baseline score, treatment group, country, visit, and visit*treatment.|Baseline, 4, 8, 16, and 24 weeks|The analysis included all randomly assigned participants who had a baseline and post-baseline SEAR Confidence observation.||units on a scale||95% Confidence Interval|Least Squares Mean
818804|NCT01122264|Secondary|Change From Baseline to 4, 8, 16, and 24 Weeks of the Sexual Relationship Domain of the Self-Esteem and Relationship (SEAR) Questionnaire|SEAR assesses psychosocial outcomes in men with erectile dysfunction. Sexual Relationship domain consists of 8 items (items 1-8). Items 2-8 are rated on a scale of 1 (Never) to 5 (Always), whereas item 1 is reverse scored (1=Always and 5=Never). The domain score was computed by summing its respective items, then transforming it into a 0 (least favorable) to 100 (most favorable) scale. Transformed score = 100 x [(actual raw score - lowest possible raw score)/possible raw score range]. Least Squares Mean changes adjusted for baseline score, treatment group, country, visit, and visit*treatment.|Baseline, 4, 8, 16, and 24 weeks|The analysis included all randomly assigned participants who had a baseline and post-baseline SEAR Sexual Relationship observation.||units on a scale||95% Confidence Interval|Least Squares Mean
818805|NCT01122264|Secondary|Change From Baseline to 24 Week Endpoint of the Sexual Self-Confidence, Spontaneity, and Time Concerns Domains (23-items) of the Psychological and Interpersonal Relationships Scale (PAIRS)|The PAIRS is a 23-item scale that assesses broader psychological/interpersonal outcomes associated with erectile dysfunction and its treatment. Each question is rated on a Likert scale from 1 (strongly disagree) to 4 (strongly agree). The scale consists of 3 domains: Sexual Self-Confidence (items 1-6), Spontaneity domain (items 7-15), and Time Concerns (items 16-23). The average domain score for each domain was calculated by adding the nonmissing items for the respective domain, then dividing by the number of nonmissing items for the respective domain. Each average domain score ranged from 1 to 4. Higher scores represent the following: greater sexual self-confidence (better outcome); greater spontaneity (better outcome); higher time concerns (worse outcome). The Least Squares Mean changes were adjusted for treatment group, country, baseline IIEF-EF severity, baseline domain score, and baseline domain score*treatment (if p<0.10).|Baseline, 24 weeks|The analysis included all randomly assigned participants who had a baseline and post-baseline PAIRS observation.||units on a scale||95% Confidence Interval|Least Squares Mean
818832|NCT01122576|Secondary|Manifest Refraction|Manifest refraction spherical equivalent (MRSE) was calculated as the value of the sphere plus one-half of the value of the cylinder.|Visit 3 (2-3 Months)|Full Analysis Set||Diopters|Participants|Standard Deviation|Mean
818833|NCT01122576|Secondary|Binocular Halo and Starburst|Halo and starburst (both monocular and binocular) were measured using a glarometer on integer scales of 1-5, where the smaller the number the better the outcome.|Visit 4 (4-6 months)|Full Analysis Set||units on a scale||Standard Deviation|Mean
818806|NCT01122264|Secondary|Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire at 4, 8, 16, and 24 Weeks|The participant questionnaire consists of 11 questions. Each question is rated on a scale of 0 (extremely low treatment satisfaction) to 4 (extremely high treatment satisfaction). The EDITS summary score was obtained by adding each individual result for all questions, dividing by the number of questions answered (mean satisfaction score), then multiplying by 25, thus obtaining a score range from 0 (extremely low treatment satisfaction) to 100 (extremely high satisfaction). Least Squares Mean changes were adjusted for treatment group, country, visit, and visit*treatment.|4, 8, 16, and 24 weeks|The analysis included all randomly assigned participants who had a baseline and post-baseline EDITS observation.||units on a scale||95% Confidence Interval|Least Squares Mean
818807|NCT01122264|Secondary|Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Overall Satisfaction Domain|Self-reported overall satisfaction on the IIEF over past 4 weeks and consists of 2 questions (items 13 and 14), each rated on a scale from 1 (very dissatisfied) to 5 (very satisfied). Total scores range from 2 to 10; lower numerical scores represent lower overall satisfaction. Least Squares Mean changes from baseline to endpoint for each visit were from a repeated measures analysis and included terms for baseline score, treatment group, country, baseline*treatment (if p<0.10), visit, and visit*treatment. The correlation matrix for the repeated observations was assumed to be unstructured.|Baseline, 4, 8, 16, and 24 weeks|The analysis included all randomly assigned participants who had a baseline and post-baseline IIEF Overall Satisfaction observation.||units on a scale||Standard Error|Least Squares Mean
818808|NCT01122264|Secondary|Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Intercourse Satisfaction Domain|Self-reported intercourse satisfaction score over past 4 weeks (1 intercourse attempt item, 2 intercourse satisfaction items). Each item range: 0 (no intercourse attempts/no satisfaction) to 5 (more attempts/high satisfaction). Total scores range: 0-15; lower scores=lower intercourse satisfaction. Least Squares Mean changes from baseline to endpoint for each visit from repeated measures analysis and included terms for baseline score, treatment group, country, baseline*treatment (if p<0.10), visit, and visit*treatment. Correlation matrix for repeated observations assumed to be unstructured.|Baseline, 4, 8, 16, and 24 weeks|The analysis included all randomly assigned participants who had a baseline and post-baseline IIEF Intercourse Satisfaction observation.||units on a scale||Standard Error|Least Squares Mean
818809|NCT01122264|Secondary|Number of Days From the 8-Week Study Visit to the Time the Participant Discontinues From All Phosphodiesterase Type 5 (PDE5) Inhibitor Treatments|The differences in time between the 8-week time point and the discontinuation of all study treatments (that is, discontinuation from the study and not switching to another treatment) are reported by the median (95% confidence interval). Duration was measured as the number of days from Week 8 to the date of the last dose of the study drug. This outcome measure was estimated using the Kaplan-Meier product-limit method.|8 weeks up to 334 days|The analysis included all randomly assigned participants who completed the 8-week randomized treatment.||days||95% Confidence Interval|Median
818810|NCT01122264|Secondary|Reasons for Discontinuation of Randomized Erectile Dysfunction Treatment|The reported reasons for a decision to discontinue from initial randomized treatment prior to Week 24 are reported. Discontinuation of randomized treatment was defined as switching between the 3 study treatments (tadalafil on demand, tadalafil once a day, or sildenafil citrate on demand) or discontinuing from all treatments. A change of dose within the same treatment was not considered as switching of treatment.|Baseline through 24 weeks|The analysis included all randomly assigned participants.||participants|||Number
818811|NCT01122264|Secondary|Patterns of Erectile Dysfunction Treatment Change|Results are reported as the number of participants per sequence of study medications (tadalafil on demand, tadalafil once a day, or sildenafil citrate on demand) that were taken as a result of switching treatments. The Other Treatment Sequence reports the number of participants per sequence of study medications that were taken as a result of switching treatments more than once. The number of participants who did not switch is also reported.|Baseline through 24 weeks|All randomly assigned participants were included in the analysis.||participants|||Number
818812|NCT01122264|Secondary|Number of Treatment Switches|The number of times participants switched erectile dysfunction medication within the 3 treatments being studied (tadalafil on demand, tadalafil once a day, or sildenafil citrate on demand).|Baseline through 24 weeks|The analysis included all randomly assigned participants who switched erectile dysfunction medication and had a baseline and post-baseline observation.||number of treatment switches||Standard Deviation|Mean
818813|NCT01122264|Secondary|Global Assessment Questions (GAQ)|The GAQ consists of 2 Yes/No/No Response (No Respo) questions. GAQ Question (Q)1: Has the treatment you have been taking during this study improved your erections? GAQ Q2: Has the treatment improved your ability to engage in sexual activity?|24 weeks|The analysis included all randomly assigned participants. The last available GAQ assessment for each participant was used in the analysis.||participants|||Number
818814|NCT01122264|Secondary|Change From Baseline to 4, 8, 16 and 24 Weeks of the Sexual Encounter Profile (SEP)|Participant-assessed diary. Has 5 questions (Question[Q]1:erection achievement, Q2:successful penetration, Q3:successful intercourse, Q4:satisfied with erection, and Q5:satisfied with sexual experience) for each sexual encounter made over specified period of time. SEP Q1-Q5 scores determined as percentage of 'Yes' responses to each of 5 questions out of all sexual attempts recorded during the time period. Least Squares Mean changes from baseline to endpoint for each visit from a repeated measures analysis included terms for baseline score, treatment group, country, visit, and visit*treatment.|Baseline, 4, 8, 16, and 24 weeks|The analysis included all randomly assigned participants who had a baseline and post-baseline SEP observation.||"percentage of yes responses"||95% Confidence Interval|Least Squares Mean
818815|NCT01122264|Secondary|Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Sexual Desire Domain|Self-reported sexual desire on IIEF over past 4 weeks; comprises 2 questions (items 11 and 12). Each question rated on a scale from 1 (almost never or low/no sexual desire) to 5 (almost always or very high sexual desire). Total scores range: 2 to 10; lower numerical scores denote lower sexual desire. Least Squares Mean changes from baseline to endpoint for each visit from repeated measures analysis and included terms for baseline score, treatment group, country, baseline*treatment (if p<0.10), visit, and visit*treatment. Correlation matrix for repeated observations assumed to be unstructured.|Baseline, 4, 8, 16, and 24 weeks|The analysis included all randomly assigned participants who had a baseline and post-baseline IIEF Sexual Desire observation.||units on a scale||Standard Error|Least Squares Mean
818816|NCT01122264|Secondary|Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Orgasmic Function Domain|Self-reported orgasmic function on the IIEF over past 4 weeks and consists of 2 questions (items 9 and 10). Each question is rated on a scale from 0 (no sexual stimulation) to 5 (almost always/always). Total scores range from 0 to 10; lower scores represent lower orgasmic function. Least Squares Mean changes from baseline to endpoint for each visit were from a repeated measures analysis and included terms for baseline score, treatment group, country, baseline*treatment (if p<0.10), visit, and visit*treatment. The correlation matrix for the repeated observations was assumed to be unstructured.|Baseline, 4, 8, 16, and 24 weeks|The analysis included all randomly assigned participants who had a baseline and post-baseline IIEF Orgasmic Function observation.||units on a scale||Standard Error|Least Squares Mean
818817|NCT01122264|Secondary|Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Erectile Function (EF) Domain|Self-reported EF score over past 4 weeks. Items 1-5 scores range from 0 (no sexual activity) to 5 (high EF). Item 15 score ranges from 1 (very low confidence to get/keep erection) to 5 (very high confidence). Total scores range from 1 to 30; lower scores denote greater erectile dysfunction severity. Least Squares Mean changes from baseline to endpoint for each visit from repeated measures analysis included terms for baseline score, treatment group, country, baseline*treatment (if p<0.10), visit, and visit*treatment. Correlation matrix for repeated observations assumed to be unstructured.|Baseline, 4, 8, 16, and 24 weeks|The analysis included all randomly assigned participants who had a baseline and post-baseline IIEF-EF observation.||units on a scale||Standard Error|Least Squares Mean
818818|NCT01122264|Primary|Time to Discontinuation of Randomized Treatment|Time to discontinuation of randomized treatment was defined as the number of days from randomization until the day the participant discontinued the randomized treatment. Discontinuation of randomized treatment was defined as switching between the 3 study treatments (tadalafil on demand, tadalafil once a day, or sildenafil citrate on demand) or discontinuing from all treatments. A change of dose within the same treatment was not considered switching of treatment. This outcome measure was estimated using the Kaplan-Meier product-limit method.|Baseline up to 334 days|The analysis included all randomly assigned participants.||days||95% Confidence Interval|Median
818819|NCT01122381|Primary|Migraine Headache Days Per 4 Week Period Comparing the Last 4 Weeks of Treatment to a 4 Week Pre-treatment Baseline.|"Compare number of migraine headache days pre and post treatment between the ESX and placebo group.
Study terminated early-no outcome data available. The single subject assigned to study drug did not actually take it according to subsequent review of ESX drug levels."|4 weeks, end of treatment and pre-treatment baseline||||||
818820|NCT01122394|Secondary|Antihypertensive/ Lipid-lowering Medication Adherence|Measured by Morisky Medication taking questionnaire (self-reported). Scores range from 0-4, with 0 being least adherent and 4 being most adherent|6 months|One participant in TI did not answer all of the questions on this assessment, so his score could not be computed and therefore he is not included in this analysis||units on a scale||Standard Deviation|Mean
818821|NCT01122394|Secondary|Exercise Adherence|Measured by 7-day Physical Activity Recall|6 months|||hours per week of cardio||Inter-Quartile Range|Median
818822|NCT01122394|Secondary|Total Cholesterol/High Density Lipoprotein Ratio||6 months|Only participants who provided a blood sample for which cholesterol could be analyzed were included in this analysis||ratio||Inter-Quartile Range|Median
818823|NCT01122394|Secondary|Dietary Sodium|self-reported stage of change for adherence to DASH (low-sodium) diet. Pre-action refers to participants reporting that they were in pre-contemplation (no plans to adhere to DASH diet in the next 6 months), contemplation (planning to adhere within the next 6 months) or preparation (planning to adhere within the next month), while action refers to participants reporting that they are in the action stage of change (became adherent to the DASH diet within the past 6 months) and maintenance refers to participants reporting that they are in the maintenance stage of change (became adherent to the DASH diet at least 6 months ago)|6 months|||participants|||Number
818824|NCT01122394|Primary|Systolic Blood Pressure||6 months|restricted to only patients enrolled because they met criteria for high blood pressure at enrollment. Participants were not included if they were did not have elevated blood pressure at enrollment||mm Hg||Inter-Quartile Range|Median
818825|NCT01122511|Secondary|Change From Baseline in Area Leakage of Choroidal Neovascularization at Month 12 as Measured by Fluorescein Angiography|Fluorescein angiography (FA) is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. Photographs are taken with a specialized low-power microscope with an attached camera designed to photograph the interior of the eye, including the retina and optic disc. FA was performed on the study eye after dilation at baseline and Week 12.|Baseline, Month 12|No participants reached the 12 month time-point. Efficacy analyses were not performed.|||||
818826|NCT01122511|Secondary|Change From Baseline in Central Retinal Thickness at Month 12 as Measured by Optical Coherence Tomography|Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed on the study eye after pupil dilation at baseline and Month 12.|Baseline, Month 12|No participants reached the 12 month time-point. Efficacy analyses were not performed.|||||
818827|NCT01122511|Secondary|The Percentage of Patients Having 15 or More Letter Improvement From Baseline in Best Corrected Visual Acuity at Month 12|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|Baseline, Month 12|No participants reached the 12 month time-point. Efficacy analyses were not performed.|||||
818828|NCT01122511|Primary|Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|Baseline, Month 12|No participants reached the 12 month time-point. Efficacy analyses were not performed.|||||
818829|NCT01122576|Secondary|Best-corrected Distance Visual Acuity|High Contrast Distance-Corrected Distance,(BCDVA), Intermediate (DCIVA), and Near Visual Acuity (DCNVA)|Visit 3 (2-3 months) Visit 4 (4-6 months)|Full Analysis Set||logMAR|Participants|Standard Deviation|Mean
818836|NCT01122576|Secondary|Monocular Halo and Starburst|Halo and starburst (both monocular and binocular) were measured using a glarometer on integer scales of 1-5, where the smaller the number the better the outcome.|Visit 3 (2-3 months)|Full Analysis Set||units on a scale|Participants|Standard Deviation|Mean
818837|NCT01122576|Secondary|Optical Scatter|Objective scatter index (OSI) was assessed using the Optical Quality Analysis System(OQAS) and summarized as a continuous variable. For this assessment, an OSI score of 1 or less represents good quality vision, 1-2 indicates some degradation but otherwise normal vision, 2-3 significant light scatter possibly requiring treatment, and scores over 4 severely compromised vision requiring intervention.|Visit 4 (4-6 months)|||units on a scale|Participants|Standard Deviation|Mean
818838|NCT01122576|Secondary|Optical Scatter|Objective scatter index (OSI) was assessed using the Optical Quality Analysis System(OQAS) and summarized as a continuous variable. For this assessment, an OSI score of 1 or less represents good quality vision, 1-2 indicates some degradation but otherwise normal vision, 2-3 significant light scatter possibly requiring treatment, and scores over 4 severely compromised vision requiring intervention.|Visit 3 (2-3 months)|Full Analysis Set||units on a scale|Participants|Standard Deviation|Mean
818839|NCT01122576|Secondary|Mesopic Binocular Contrast Sensitivity With Glare 18 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 4 (4-6 months)|Full analysis set||log contrast sensitivity units||Standard Deviation|Mean
818840|NCT01122576|Secondary|Mesopic Binocular Contrast Sensitivity With Glare 12 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 4 (4-6 months)|Full analysis set||log contrast sensitivity units||Standard Deviation|Mean
818841|NCT01122576|Secondary|Mesopic Binocular Contrast Sensitivity With Glare 6 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 4 (4-6 months)|Full analysis set||log contrast sensitivity units||Standard Deviation|Mean
818842|NCT01122576|Secondary|Mesopic Binocular Contrast Sensitivity With Glare 1.5, 3 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 4 (4-6 months)|Full analysis set||log contrast sensitivity units||Standard Deviation|Mean
818843|NCT01122576|Secondary|Mesopic Binocular Contrast Sensitivity With Glare 18 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 3 (2-3 months)|Full analysis set||log contrast sensitivity units||Standard Deviation|Mean
818844|NCT01122576|Secondary|Mesopic Binocular Contrast Sensitivity With Glare 12 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 3 (2-3 months)|Full analysis set||log contrast sensitivity units||Standard Deviation|Mean
818845|NCT01122576|Secondary|Mesopic Binocular Contrast Sensitivity With Glare 6 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 3 (2-3 months)|Full analysis set||log contrast sensitivity units||Standard Deviation|Mean
818846|NCT01122576|Secondary|Mesopic Binocular Contrast Sensitivity With Glare 1.5, 3 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 3 (2-3 months)|Full analysis set||log contrast sensitivity units||Standard Deviation|Mean
818847|NCT01122576|Secondary|Mesopic Monocular Contrast Sensitivity With Glare 18 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 4 (4-6 months)|Full analysis set||log contrast sensitivity units|Participants|Standard Deviation|Mean
818848|NCT01122576|Secondary|Mesopic Monocular Contrast Sensitivity With Glare 12 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 4 (4-6 months)|Full analysis set||log contrast sensitivity units|Participants|Standard Deviation|Mean
818849|NCT01122576|Secondary|Mesopic Monocular Contrast Sensitivity With Glare 6 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 4 (4-6 months)|Full analysis set||log contrast sensitivity units|Participants|Standard Deviation|Mean
818850|NCT01122576|Secondary|Mesopic Monocular Contrast Sensitivity With Glare 3 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 4 (4-6 months)|Full analysis set||log contrast sensitivity units|Participants|Standard Deviation|Mean
819016|NCT01132508|Secondary|Knee Function and Stability: Extension Stability at 78 Weeks|Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.|78 weeks|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
818851|NCT01122576|Secondary|Mesopic Monocular Contrast Sensitivity With Glare 1.5 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 4 (4-6 months)|Full analysis set||log contrast sensitivity units|Participants|Standard Deviation|Mean
818852|NCT01122576|Secondary|Mesopic Monocular Contrast Sensitivity With Glare 18 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 3 (2-3 months)|Full analysis set||log contrast sensitivity units|Participants|Standard Deviation|Mean
818853|NCT01122576|Secondary|Mesopic Monocular Contrast Sensitivity With Glare 12 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 3 (2-3 months)|Full analysis set||log contrast sensitivity units|Participants|Standard Deviation|Mean
818854|NCT01122576|Secondary|Mesopic Monocular Contrast Sensitivity With Glare 6 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 3 (2-3 months)|Full analysis set||log contrast sensitivity units|Participants|Standard Deviation|Mean
818855|NCT01122576|Secondary|Mesopic Monocular Contrast Sensitivity With Glare 3 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 3 (2-3 months)|Full analysis set||log contrast sensitivity units|Participants|Standard Deviation|Mean
818856|NCT01122576|Secondary|Mesopic Monocular Contrast Sensitivity With Glare 1.5 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 3 (2-3 months)|Full analysis set||log contrast sensitivity units|Participants|Standard Deviation|Mean
818857|NCT01122576|Secondary|Binocular Mesopic Contrast Sensitivity Without Glare 18 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 4 (4-6 months)|Full analysis set||log contrast sensitivity units||Standard Deviation|Mean
818858|NCT01122576|Secondary|Binocular Mesopic Contrast Sensitivity Without Glare 12 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 4 (4-6 months)|Full analysis set||log contrast sensitivity units||Standard Deviation|Mean
818859|NCT01122576|Secondary|Binocular Mesopic Contrast Sensitivity Without Glare 1.5, 3, 6 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 4 (4-6 months)|Full analysis set||log contrast sensitivity units||Standard Deviation|Mean
818860|NCT01122576|Secondary|Binocular Mesopic Contrast Sensitivity Without Glare 18 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 3 (2-3 months)|Full analysis set||log contrast sensitivity units||Standard Deviation|Mean
818861|NCT01122576|Secondary|Binocular Mesopic Contrast Sensitivity Without Glare 12 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 3 (2-3 months)|Full analysis set||log contrast sensitivity units||Standard Deviation|Mean
818862|NCT01122576|Secondary|Binocular Mesopic Contrast Sensitivity Without Glare 6 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 3 (2-3 months)|Full analysis set||log contrast sensitivity units||Standard Deviation|Mean
818863|NCT01122576|Secondary|Binocular Mesopic Contrast Sensitivity Without Glare 1.5 & 3 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 3 (2-3 months)|Full set analysis||log contrast sensitivity units||Standard Deviation|Mean
818864|NCT01122576|Primary|Mesopic Monocular Contrast Sensitivity Without Glare 18 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Postoperative visit 4 ( 4-6 months)|Full analysis set||log contrast sensitivity units|Participants|Standard Deviation|Mean
818865|NCT01122576|Primary|Mesopic Monocular Contrast Sensitivity Without Glare 12 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Postoperative visit 4 ( 4-6 months)|Full analysis set||log contrast sensitivity units|Participants|Standard Deviation|Mean
818866|NCT01122576|Primary|Mesopic Monocular Contrast Sensitivity Without Glare 6 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Postoperative visit 4 ( 4-6 months)|Full analysis set||log contrast sensitivity units|Participants|Standard Deviation|Mean
818867|NCT01122576|Primary|Mesopic Monocular Contrast Sensitivity Without Glare 3 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Postoperative visit 4 ( 4-6 months)|Full analysis set||log contrast sensitivity units|Participants|Standard Deviation|Mean
818868|NCT01122576|Primary|Mesopic Monocular Contrast Sensitivity Without Glare 1.5 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Postoperative visit 4 ( 4-6 months)|Full analysis set||log contrast sensitivity units|Participants|Standard Deviation|Mean
818869|NCT01122576|Primary|Mesopic Monocular Contrast Sensitivity Without Glare 18 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Postoperative visit 3 (2-3 months)|Full analysis set||log contrast sensitivity units|Participants|Standard Deviation|Mean
818870|NCT01122576|Primary|Mesopic Monocular Contrast Sensitivity Without Glare 12 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Postoperative visit 3 (2-3 months)|Full analysis set||log contrast sensitivity units|Participants|Standard Deviation|Mean
818871|NCT01122576|Primary|Mesopic Monocular Contrast Sensitivity Without Glare 6 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Postoperative visit 3 (2-3 months)|Full analysis set||log contrast sensitivity units|Participants|Standard Deviation|Mean
818872|NCT01122576|Primary|Mesopic Monocular Contrast Sensitivity Without Glare 1.5 and 3 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Postoperative visit 3 (2-3 months)|Full analysis set||log contrast sensitivity units|Participants|Standard Deviation|Mean
818873|NCT01122680|Secondary|Change From Baseline in Mean Number of Nighttime Awakenings|Mean number of nighttime awakenings due to asthma symptoms as assessed by patients eDiary incorporated in the AM3® device. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and last week of treatment (week 4)|FAS with non-missing data for nighttime awakenings||Night awakenings per week||Standard Error|Least Squares Mean
818874|NCT01122680|Secondary|Control of Asthma as Assessed by Asthma Control Questionnaire (ACQ)|ACQ is a questionnaire consisting of a seven point Likert scale ranging from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The scale describes the frequency and severity of asthma symptoms. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|4 weeks|FAS with non-missing ACQ data||Units on a scale||Standard Error|Least Squares Mean
818875|NCT01122680|Secondary|Change From Baseline in the Number of Puffs of Rescue Medication Per Day|Mean number of inhalations (puffs) of unscheduled rescue salbutamol therapy during whole day. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|FAS with non-missing data for rescue medication||Puffs/day||Standard Error|Least Squares Mean
818876|NCT01122680|Secondary|Mean Evening PEF Response|Mean evening PEF assessed by patients at home. Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|FAS with non-missing evening PEF data||Litre/min||Standard Error|Least Squares Mean
818877|NCT01122680|Secondary|Mean Morning Peak Expiratory Flow (PEF) Response|Mean morning PEF assessed by patients at home. Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|FAS with non-missing morning PEF data||Litre/min||Standard Error|Least Squares Mean
818878|NCT01122680|Secondary|Forced Expiratory Flow (FEF) 25-75% Individual Measurements Response at Each Time Point|FEF 25-75% is the mean forced expiratory flow between 25% and 75% of the FVC determined at the end of the 4-week treatment period. This is often referred to as the maximum midexpiratory flow. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks (10 min pre-dose, 30 min, 1,2,3 hours post-dose)|FAS with non-missing FEF data||Litre||Standard Error|Least Squares Mean
818879|NCT01122680|Secondary|FVC Individual Measurements at Each Time-point|"Individual FVC measurements at each time-point (personal best). Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model."|Baseline and 4 weeks (10 min pre-dose, 30 min, 1,2,3 hours post-dose)|FAS with non-missing FVC data.||Litre||Standard Error|Least Squares Mean
818880|NCT01122680|Secondary|FVC Area Under the Curve From 0 to 3 h (AUC0-3h) Response|FVC (AUC0-3h) will be calculated as the area under the curve from 0 to 3hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|FAS with non-missing FVC data.||Litre||Standard Error|Least Squares Mean
818881|NCT01122680|Secondary|FVC Trough Response|The trough FVC response is defined as the pre-dose FVC measured just prior to the last administration of randomised treatment. Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|FAS with non-missing FVC data.||Litre||Standard Error|Least Squares Mean
818882|NCT01122680|Secondary|Forced Vital Capacity (FVC) Peak (0-3h) Response|The FVC peak (0-3h) response is determined at the end of the 4 week treatment period. This is the difference between the maximum FVC measured within the first 3 hours post dosing and the FVC baseline measurement. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|FAS with non-missing FVC data.||Litre||Standard Error|Least Squares Mean
818883|NCT01122680|Secondary|FEV1 Individual Measurements Response at Each Time-point|"Individual FEV1 measurements at each time-point (personal best). Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model."|Baseline and 4 weeks (10 min pre-dose, 30 min, 1,2,3 hours post-dose)|FAS with non-missing FEV1 data.||Litre||Standard Error|Least Squares Mean
818884|NCT01122680|Secondary|FEV1 Area Under the Curve From 0 to 3 h (AUC0-3h) Response|FEV1 (AUC0-3h) will be calculated as the area under the curve from 0 to 3hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|FAS with non-missing FEV1 data.||Litre||Standard Error|Least Squares Mean
818885|NCT01122680|Secondary|Trough FEV1 Response|The trough FEV1 is defined as the pre-dose FEV1 measured just prior to the last administration of randomised treatment. Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|FAS with non-missing FEV1 data.||Litre||Standard Error|Least Squares Mean
818886|NCT01122680|Primary|Forced Expiratory Volume (FEV1) Peak (0-3h) Response|The FEV1 peak (0-3h) response is determined at the end of the 4 week treatment period. This is the difference between the maximum FEV1 measured within the first 3 hours post dosing and the FEV1 baseline measurement. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|The Full analysis set (FAS) is defined as patients randomised, treated, with baseline data and at least one on-treatment efficacy measurement after 4 weeks on treatment within a period. This patient set is therefore FAS reduced to patients with non-missing FEV1 data.||Litre||Standard Error|Least Squares Mean
818887|NCT01122862|Secondary|Interproximal Plaque Index After 24 Hours of Treatment Administration|Plaque scores were assessed using Turesky Modification of the Quigley Hein Index and categorized as 0: No plaque; 1: Slight flecks of plaque at the cervical margin of the tooth;2: A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth;3: A band of plaque wider than 1 mm but covering less than 1/3 of the crown of the tooth;4: Plaque covering at least 1/3 but less than 2/3 of the crown of the tooth;5: Plaque covering 2/3 or more of the crown of the tooth. The interproximal plaque index was calculated by taking the average of plaque scores over the mesiofacial, distofacial, mesiolingual and distolingual surfaces in the upper and lower jaws for a participant.|Day 1 post treatment administration|ITT population: All randomized participants who received study treatment and had at least one post-baseline efficacy measurement. Due to drop outs, there was difference in number of participants analyzed for this outcome measure. Missing data was not imputed.||Score on a scale||Standard Error|Mean
818888|NCT01122862|Secondary|Interproximal Plaque Index After Day 4 of Treatment Administration|Plaque scores were assessed using Turesky Modification of the Quigley Hein Index and categorized as 0: No plaque; 1: Slight flecks of plaque at the cervical margin of the tooth;2: A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth;3: A band of plaque wider than 1 mm but covering less than 1/3 of the crown of the tooth;4: Plaque covering at least 1/3 but less than 2/3 of the crown of the tooth;5: Plaque covering 2/3 or more of the crown of the tooth. The interproximal plaque index was calculated by taking the average of plaque scores over the mesiofacial, distofacial, mesiolingual and distolingual surfaces in the upper and lower jaws for a participant.|Day 4 post treatment administration|ITT population: All randomized participants who received study treatment and had at least one post-baseline efficacy measurement. Due to drop outs, there was difference in number of participants analyzed for this outcome measure. Missing data was not imputed.||Score on a scale||Standard Error|Mean
818889|NCT01122862|Secondary|Plaque Index After 24 Hours of Treatment Administration|Plaque scores were assessed using Turesky Modification of the Quigley Hein Index and categorized as 0: No plaque; 1: Slight flecks of plaque at the cervical margin of the tooth;2: A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth;3: A band of plaque wider than 1 mm but covering less than 1/3 of the crown of the tooth;4: Plaque covering at least 1/3 but less than 2/3 of the crown of the tooth;5: Plaque covering 2/3 or more of the crown of the tooth. The interproximal plaque index was calculated by taking the average of plaque scores over the mesiofacial, distofacial, mesiolingual and distolingual surfaces in the upper and lower jaws for a participant.|Day 1 post treatment administration|ITT population: All randomized participants who received study treatment and had at least one post-baseline efficacy measurement. Due to drop outs, there was difference in number of participants analyzed for this outcome measure. Missing data was not imputed.||Score on a scale||Standard Error|Mean
818890|NCT01122862|Secondary|Plaque Index Score of Test Mouth Rinse Versus Chlorhexidine Mouth Rinse After Day 4 of Treatment Administration|Plaque scores were assessed using Turesky Modification of the Quigley Hein Index and categorized as 0: No plaque; 1: Slight flecks of plaque at the cervical margin of the tooth;2: A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth;3: A band of plaque wider than 1 mm but covering less than 1/3 of the crown of the tooth;4: Plaque covering at least 1/3 but less than 2/3 of the crown of the tooth;5: Plaque covering 2/3 or more of the crown of the tooth. The interproximal plaque index was calculated by taking the average of plaque scores over the mesiofacial, distofacial, mesiolingual and distolingual surfaces in the upper and lower jaws for a participant.|Day 4 post treatment administration|ITT population: All randomized participants who received study treatment and had at least one post-baseline efficacy measurement. Due to drop outs, there was difference in number of participants analyzed for this outcome measure. Missing data was not imputed.||Score on a scale||Standard Error|Mean
818907|NCT01122927|Secondary|Mean Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score|"The severity of illness for each participant was rated using the CGI-S scale. To assess CGI-S, the study physician answered the following question: Considering your total clinical experience with this particular population, how mentally ill is the participant at this time? Response choices included: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants."|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.||Units on a scale||Standard Deviation|Mean
818891|NCT01122862|Primary|Plaque Index of Test Mouth Rinse Versus Sterile Water After Day 4 of Treatment Administration|Plaque scores were assessed using Turesky Modification of the Quigley Hein Index and categorized as 0: No plaque; 1: Slight flecks of plaque at the cervical margin of the tooth;2: A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth;3: A band of plaque wider than 1 mm but covering less than 1/3 of the crown of the tooth;4: Plaque covering at least 1/3 but less than 2/3 of the crown of the tooth;5: Plaque covering 2/3 or more of the crown of the tooth. The interproximal plaque index was calculated by taking the average of plaque scores over the mesiofacial, distofacial, mesiolingual and distolingual surfaces in the upper and lower jaws for a participant.|Day 4 post treatment administration|Intention to Treat (ITT) population: All randomized participants who received study treatment and had at least one post-baseline efficacy measurement. Due to drop outs, there was difference in number of participants analyzed for this outcome measure. Missing data was not imputed.||Score on a scale||Standard Error|Mean
818892|NCT01122901|Secondary|Progression Free Survival|Time to event endpoints for Group A will be measured from the date of first dose. All patients who receive at least one dose of study drug will be included in the analysis. Time to event endpoints for Group B will be measured from the first post-surgical date (this will be considered start date of treatment). Progression defined as: >25% increase sum of products of perpendicular diameters (bi-dimensional measurements) of enhancing lesions (over baseline (BL) if no decrease) on stable or increasing doses of corticosteroids. and/or b) Significant increase in T2/FLAIR nonenhancing lesion on stable or increasing doses of corticosteroids compared to BL scan or best response following initiation of therapy c) Any new lesion. d) Clear clinical deterioration not attributable to other causes apart from the tumor e) Failure to return for evaluation due to death or deteriorating condition.|2 years|||months||95% Confidence Interval|Median
818893|NCT01122901|Secondary|Tumor Propagation (Group B)|This outcome could not be analyzed as the n was too small. The study was terminated prematurely by Hoffman-La Roche Company due to their decision to terminate drug supply for further development of this drug. All CTEP-sponsored trials using RO4929097 were closed to accrual and all patients had to be off treatment by 7/31/12.|At the time of surgery|This outcome could not be analyzed as the n was too small. The study was terminated prematurely by Hoffman-La Roche Company due to their decision to terminate drug supply for further development of this drug.|||||
818894|NCT01122901|Secondary|Expression Levels of Notch Pathway Components and Downstream (Group B)|This outcome could not be analyzed as the n was too small. The study was terminated prematurely by Hoffman-La Roche Company due to their decision to terminate drug supply for further development of this drug. All CTEP-sponsored trials using RO4929097 were closed to accrual and all patients had to be off treatment by 7/31/12.|At the time of surgery|This outcome could not be analyzed as the n was too small. The study was terminated prematurely by Hoffman-La Roche Company due to their decision to terminate drug supply for further development of this drug.|||||
818895|NCT01122901|Secondary|Overall Survival|"time to event endpoints for Group A will be measured from date of first dose. All patients who receive at least one dose will be included in analysis.
Time to event endpoints for Group B will be measured from the first post-surgical date (this will be considered start date of treatment)."|2 years|||months||95% Confidence Interval|Median
818896|NCT01122901|Secondary|Number of Participants With Toxicities Associated With Study Drug (Group A and Group B)|assessed by the National Cancer Institute CTCAE version 4.0 assessed if patient received at least one dose of study drug Grade 3-5 toxicities grade 3 -severe grade 4 - life threatening grade 5 - death|Up to 30 days after completion of study treatment|||Participants|||Count of Participants
818897|NCT01122901|Secondary|Radiographic Response Rate According to the Radiographic Assessment in Neuro-Oncology Criteria (Group A) and Group (B)|"RANO:
Measurable: Bidimensionally measurable lesions w/ clearly defined margins by MRI Evaluable: Unidimensionally measurable lesions, masses w/margins not clearly defined.
Complete Response (CR): Complete disappearance of all measurable/evaluable disease. No new lesions. No evidence of non-evaluable disease. Patients on minimal/no steroids.
Partial Response (PR): >/= to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. Responders must be on same/decreasing doses of dexamethasone.
Stable/No Response: Does not qualify for CR, PR, or progression.
Progression: 25% increase in the sum of products of all measurable lesions over smallest sum observed (over BL if no decrease), OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer)."|Up to 6 months after completion of treatment|||Participants|||Count of Participants
818898|NCT01122901|Primary|Efficiency of Neurosphere Generation After Pretreatment With RO4929097 (Group B)|This outcome could not be analyzed as the n was too small. The study was terminated prematurely by Hoffman-La Roche Company due to their decision to terminate drug supply for further development of this drug. All CTEP-sponsored trials using RO4929097 were closed to accrual and all patients had to be off treatment by 7/31/12.|At time of surgery|This outcome could not be analyzed as the n was too small. Only had 7 samples. The study was terminated prematurely by Hoffman-La Roche Company due to their decision to terminate drug supply for further development of this drug|||||
818899|NCT01122901|Primary|Overall Median Progression-free Survival (6-month PFS)|Time to event endpoints for Group A will be measured from the date of first dose. All patients who receive at least one dose of study drug will be included in the analysis. Time to event endpoints for Group B will be measured from the first post-surgical date (this will be considered start date of treatment). Progression defined as: >25% increase sum of products of perpendicular diameters (bi-dimensional measurements) of enhancing lesions (over baseline (BL) if no decrease) on stable or increasing doses of corticosteroids. and/or b) Significant increase in T2/FLAIR nonenhancing lesion on stable or increasing doses of corticosteroids compared to BL scan or best response following initiation of therapy c) Any new lesion. d) Clear clinical deterioration not attributable to other causes apart from the tumor e) Failure to return for evaluation due to death or deteriorating condition.|At 6 months|||months||95% Confidence Interval|Median
818992|NCT01132118|Primary|Insulin Sensitivity Index|"We will examine the effect of HCQ on the Matsuda Insulin Sensitivity Index (ISI) during the active treatment phase compared with placebo phase.
ISI is based on insulin and glucose levels in a fasting state during an oral glucose tolerance test (OGTT) and is calculated as follows:
ISI (Matsuda) = 10000/√ G0 X I0 X Gmean X Imean
G0 - fasting plasma glucose (mg/dL) I0 - fasting plasma insulin (mIU/L) Gmean - mean plasma glucose during OGTT (mg/dL) Imean - mean plasma insulin during OGTT (mIU/L)"|Baseline and Week 8|||(dL x L)/(mg x mIU)||Standard Deviation|Mean
818900|NCT01122927|Secondary|Mean Change From Baseline in Children's Global Assessment Scale (CGAS) in Bipolar (de Novo Participants)|The CGAS is a 100-point rating scale measuring psychological, social, and school functioning for children aged 6 to 17. It was adapted from the Adults Global Assessment Scale. The Global Assessment Scale was a rating scale for evaluating the overall functioning of a participant during a specified time period on a continuum from psychological or psychiatric sickness to health. The CGAS is a valid and reliable tool for rating a child's general level of functioning on a health-illness continuum. The CGAS was developed by Schaffer and colleagues to provide a global measure of severity of disturbance in children and adolescents. The CGAS Score (range 1 to 100) is a single-item score for rating a child’s general level of functioning on a health-illness continuum, with higher scores representing better functioning.|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.||Units on a scale||Standard Deviation|Mean
818901|NCT01122927|Secondary|Mean Change From Baseline in the Attention Deficit Hyperactive Disorders Rating (ADHD-RS-IV) Scale Score|The ADHD-RS-IV is a reliable and easy-to-administer instrument both for diagnosing ADHD in children and adolescents and for assessing treatment response. Containing 18 items, the scale was linked directly to DSM-IV-TR diagnostic criteria for ADHD. There were 3 versions of the scale: a parent questionnaire on home behaviors (English), a parent questionnaire on home behaviors (Spanish), and a teacher questionnaire on classroom behaviors. For this trial, the parent questionnaire on home behaviors (English) was utilized. The ADHD-RS-IV Total Score (range 0 to 54) is the sum of rating scores for 18 items, with higher scores representing greater severity. A missing value for any ADHD-RS-IV assessment items could have resulted in a missing ADHD-RS-IV Total Score. Data were only available for 82 participants with bipolar disorder and these were de novo participants.|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.||Units on a scale||Standard Deviation|Mean
818902|NCT01122927|Secondary|Mean Change From Baseline in General Behavior Inventory (GBI) Scale Total Score for Mania and Depression in Both Parent/Guardian and Subject Version of the Scale|The GBI is a self-report inventory with 73 items focusing on mood-related behaviors, including depressive, hypomanic, and biphasic symptoms. For this trial, two 20-item subscales were utilized: one was completed by the parent/guardian or legal representative, as applicable for local laws, and the other was completed by the participant. Responses were given on a 4-point Likert scale, with 0 being never or hardly ever and 3 being very often or almost constantly. The GBI Total Score for mania (range 0 to 30) is the sum of scores for items 1 to 10 and the GBI Total Score for depression (range 0 to 30) is the sum of scores for items 11 to 20 in the GBI Parent/Guardian or Subject Version panel. Scores from the Parent/Guardian and participant Versions were summarized separately. A missing value for any GBI assessment items could have resulted in a missing GBI Total Score. High scores represent greater psychopathology. Data was only available for 80 de novo participants with bipolar disorder.|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.||Units on a scale||Standard Deviation|Mean
818903|NCT01122927|Secondary|Mean Change From Baseline in Clinical Global Impression Scale - Bipolar Version Improvement Score|The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rated the subject’s Severity of Illness (CGI-BP-Severity: mania, depression, and overall bipolar illness) and Change From Preceding Phase (CGI-BP-Improvement: mania, depression, and overall bipolar illness) based on a 7- or 8-point scale. Severity of Illness (CGI-BP-Severity) was rated at all visits. At each visit other than Day 0 (Baseline), the Change From Preceding Phase (CGI-BP-Improvement) was judged with respect to participant's condition at Baseline. The CGI-BP Severity Scores (range 1 to 7), as well as CGI-BP Improvement Scores (range 1 to 7) are single-item rating scores, with higher scores representing greater severity or less improvement. Only 94 participants had data at Baseline to explain the N=94 in the table below and these were de novo participants.|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.||Units on a scale||Standard Deviation|Mean
818904|NCT01122927|Secondary|Mean Change From Baseline in Clinical Global Impression Scale - Bipolar (CGI-BP) Version Severity Score|The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rated the subject’s Severity of Illness (CGI-BP-Severity: mania, depression, and overall bipolar illness) and Change From Preceding Phase (CGI-BP-Improvement: mania, depression, and overall bipolar illness) based on a 7- or 8-point scale. Severity of Illness (CGI-BP-Severity) was rated at all visits. At each visit other than Day 0 (Baseline), the Change From Preceding Phase (CGI-BP-Improvement) was judged with respect to participant's condition at Baseline. The CGI-BP Severity Scores (range 1 to 7), as well as CGI-BP Improvement Scores (range 1 to 7) are single-item rating scores, with higher scores representing greater severity or less improvement. Data for 94 de novo participants were available with bipolar disorder.|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.||Units on a scale||Standard Deviation|Mean
818905|NCT01122927|Secondary|Mean Change From Baseline in Young Mania Rating Scale (YMRS) Score|The YMRS consists of 11 items assessing the core symptoms of mania and was used to assess participants with bipolar I disorder, manic and mixed episodes with or without psychotic features: elevated mood, increased motor activity - energy, sexual interest, sleep, irritability, speech (rate and amount), language - thought disorder, content, disruptive - aggressive behavior, appearance, and insight. Each item had 5 or 9 grades of severity, with lower scores indicating milder symptoms. The number of raters within each trial center was to be kept to a minimum. The YMRS Total Score (range 0 to 44) is the sum of the rating scores for 11 items for assessing the core symptoms of mania. A missing value for any YMRS assessment item(s) could have resulted in a missing YMRS Total Score. A higher YMRS Total Score represents greater severity. In this study, 94 participants had bipolar disorder, this explains the N=94 in the table below and these were de novo participants.|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.||Units on a scale||Standard Deviation|Mean
818906|NCT01122927|Secondary|Mean Change in Clinical Global Impression-Improvement (CGI-I) Score|The efficacy of trial medication were rated for each participant using the CGI-I scale. The study physician must rate the participant's total improvement whether or not it is due entirely to drug treatment. All responses were compared to the participant's condition at baseline. Response choices include: 0 = not assessed; 1 =very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 =minimally worse; 6 = much worse; and 7 = very much worse.|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.||Units on a scale||Standard Deviation|Mean
818908|NCT01122927|Secondary|Mean Change From Baseline in PANSS Negative Subscale Score|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS Negative Subscale ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms).|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.||Units on a scale||Standard Deviation|Mean
818909|NCT01122927|Secondary|Mean Change From Baseline in PANSS Positive Subscale Score|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS positive subscale score was the sum of the rating scores for the 7 positive scale items from the PANSS panel. The 7 positive symptom constructs are delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS Positive Subscale ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms).|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.||Units on a scale||Standard Deviation|Mean
818910|NCT01122927|Secondary|Mean Change From Baseline in Positive and Negative Symptoms Score (PANSS) Total Score|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.||Units on a scale||Standard Deviation|Mean
818911|NCT01122927|Secondary|Percentage of Participants Who Discontinued Due to All Adverse Events|The percentage of participants who discontinued due to all causes other than sponsor terminating the trial was measured from the date of entering the open-label treatment phase to the date of ET for discontinued participants in the open-label treatment phase (ie, time to discontinuation = date of discontinuation [or date of completion for completed participants] − date of participant entering the open-label treatment phase + 1). If the participants completed the trial or were discontinued due to the sponsor terminating the trial, they were censored at the time of completion or trial termination, respectively.|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.||percentage of participants|||Number
818912|NCT01122927|Secondary|Incidence of Suicidality, Suicidal Behavior and Suicidal Ideation|Suicidality was defined as reporting at least one occurrence of any suicidal behavior or suicidal ideation. Suicidal behavior was defined as reporting any type of suicidal behaviors (actual attempt, interrupted attempt, aborted attempt, and preparatory acts or behavior). Suicidal ideation was defined as reporting any type of suicidal ideation. The below reported N value is the number of participants with specified suicidal ideation/behavior at the given time point.|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.||participants|||Number
818913|NCT01122927|Secondary|Mean Change From Baseline for Columbia-Suicide Severity Rating Scale (C-SSRS) in Suicidal Ideation Intensity Total Score|Suicidality was defined as reporting at least one occurrence of any suicidal behavior or suicidal ideation. Suicidal behavior was defined as reporting any type of suicidal behaviors (actual attempt, interrupted attempt, aborted attempt, and preparatory acts or behavior). Suicidal ideation was defined as reporting any type of suicidal ideation. The suicidal ideation intensity total score is the sum of intensity scores of 5 items (frequency, duration, controllability, deterrents, and reasons for ideation). The score of each intensity item ranges from 0 (none) to 5 (worst) which leads to the range of the total score from 0 to 25. A missing score of any item resulted in a missing total score. If no suicidal ideation was reported, a score of 0 was given to the intensity scale.|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.||Units on a scale||Standard Deviation|Mean
818914|NCT01122927|Secondary|Baseline and Post-Baseline Tanner Staging|Tanner staging was completed together with the physical examination by the same trial-affiliated clinician in the most inconspicuous manner for the participant as possible. Tanner staging assessment consisted of 2 domains (pubic hair and breast development) for girls and 3 domains (pubic hair, penis development, and testes development) for boys. A participant who reached Stage 5 (both in pubic hair and genitalia) did not need to continue with Tanner Staging assessment and the Tanner Staging scales of this participant were imputed as 5 for all of the following scheduled time points up to and including the completion visit/ET visit. The clinician arrived at a single score summarizing the domains (not individual domain scores) when evaluating the participant. The total shift data for last visit is presented below.|Baseline to Last Visit|All those participants who had received at least one dose of oral aripiprazole during the open-label treatment phase.||participants|||Number
818915|NCT01122927|Secondary|Number of Participants With Cognitive Impairment for Each New York Assessment for Adverse Cognitive Effects of Neuropsychiatric Treatment (NY-AACENT)|The NY-AACENT is not a validated scale. It was included in this trial because of concerns that regulatory authorities (the European Committee for Medicinal Products for Human Use [CHMP] and the Paediatric Sub-Committee of the European Medicinal Agency [PDCO]) had regarding drug induced cognitive impairment. No validated scale addressing these issues was available at the time of the trial. The NY-AACENT was used to detect changes in cognitive function subsequent to pharmacological or similar treatments for neurological or psychiatric problems. It was specifically designed to be used in pediatric populations (ages 12 to 17), but could have been utilized with other age groups, as appropriate.|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.||participants|||Number
818916|NCT01122927|Secondary|Mean Change From Baseline by Week in Barnes Akathisia Rating Scale (BARS) Score|The BARS was an EPS rating scale. The BARS was used to assess the presence and severity of akathisia. This scale consists of 4 items. Only the 4th item, the Global Clinical Assessment of Akathisia, was evaluated in this trial. This item is rated on a 6 point scale, with 0 being best (absent) and 5 being worst (severe akathisia).|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.||Units on a scale||Standard Deviation|Mean
818917|NCT01122927|Secondary|Mean Change From Baseline by Week in Simpson-Angus Scale (SAS) Total Score|The SAS is a rating scale used to measure EPS. The SAS scale consists of a list of 10 symptoms of parkinsonism (gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, head rotation, glabella tap, tremor, salivation, and akathisia), with each item rated from 0 to 4, with 0 being normal and 4 being the worst. The SAS Total score is sum of ratings for all 10 items, with possible Total scores from 0 to 40.|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.||Units on a scale||Standard Deviation|Mean
818918|NCT01122927|Secondary|Mean Change From Baseline by Week in Abnormal Involuntary Movement Scale (AIMS)|The AIMS Scale was an extrapyramidal symptoms (EPS) rating scale. The AIMS is a 12 item scale. The first 10 items e.g. facial and oral movements (items 1-4), extremity movements (items 5 and 6), trunk movements (item 7), investigators global assessment of dyskinesia (items 8 to 10). The first 10 items are rated from 0 to 4 (0=best, 4=worst). Items 11 and 12, related to dental status, have dichotomous responses, 0=no and 1=yes. The AIMS Total Score is the sum of the ratings for the first seven items. The possible total scores are from 0 to 28.|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.||Units on a scale||Standard Deviation|Mean
818919|NCT01122927|Secondary|Incidence of Vital Signs of Potential Clinical Relevance|Vital signs are taken at Baseline, Weeks 1, 2, 3, 4, 6, 8, and Months 3, 4, 6, 9, 12, 15, 18, 21, 24 of Phase 2 (Visits beyond Month 12 only for de novo subjects). Assessments included orthostatic (supine and standing) blood pressure (BP), heart rate and body temperature. Incidence of TEAEs of potential clinical relevance included abnormal values in heart rate, systolic and diastolic blood pressure, respiratory rate and weight that were identified based on pre-defined criteria. Abnormal vital signs in participants were reported as SAE/AEs and are reported in the SAE/other AE section of this report.|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.||participants|||Number
818920|NCT01122927|Secondary|Incidence of Physical Examination Findings of Potential Clinical Relevance|The physical examination evaluation was one of the parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in the following body systems: head, ears, eyes, nose, and throat; thorax; abdomen; urogenital; extremities; neurological; and skin and mucosae.|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole. Any clinically relevant abnormal changes were recorded as TEAEs.||participants|||Number
818921|NCT01122927|Secondary|Incidence of Laboratory Values of Potential Clinical Relevance|The laboratory values were one of the parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal values in serum chemistry, hematology, urinalyses and prolactin tests that were identified based on pre-defined criteria. Abnormal laboratory values in participants were reported as SAE/AEs and are reported in the SAE/other AE section of this report.|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.||participants|||Number
818922|NCT01122927|Primary|Number of Participants With Adverse Events (AEs)|An AE was defined as any untoward medical occurrence in a participant or participant enrolled in a clinical trial and which did not necessarily have a causal relationship with the study medication. A treatment emergent adverse event (TEAE) was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study medication, whether or not considered to have a causal relationship with the study medication. A serious-AE or reaction was any untoward occurrence that, at any dose, was fatal, life-threatening, required inpatient hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was any other medically significant event that, based on appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed above.|Adverse events were recorded from the time of the informed consent was signed throughout the 24 month treatment period until the follow-up visit 30 (± 3) days after the end of trial.|All participants who had received at least one dose of oral aripiprazole.||Participants|||Number
818923|NCT01123083|Secondary|Composite Rank Sum: C-Peptide AUC, HbA1c and Exogenous Insulin Use at 6 and 12 Months|O'Brien analyses was performed on a three-part composite of HbA1c level, C-peptide AUC, and mean daily insulin use in the otelixizumab group compared with the placebo group at Months 6 and 12. The three variables was adjusted for Baseline values. Baseline adjustment was used to reduce the potential impact of imbalances in Baseline levels between treatment groups on the treatment comparisons at later time points. HbA1c and insulin use was ranked from smallest to largest, and C-peptide AUC was ranked from largest to smallest. If otelixizumab treatment was effective on the composite endpoint, then the mean of the ranks sum in the otelixizumab group was smaller than the mean of the ranks sum in the placebo group.|Month 6 and 12|ITT population. Only those participants available at the indicated time points were analyzed.||Rank||Standard Deviation|Mean
818924|NCT01123083|Secondary|Composite Rank Sum: HbA1c and Exogenous Insulin Use at 6 and 12 Months|O'Brien mean rank analyses was performed on a two-part composite of the Baseline-adjusted HbA1c level and the Baseline-adjusted mean total daily insulin use per kg body weight in the otelixizumab group compared with the placebo group at Months 6 and 12. Baseline adjustment was used to reduce the potential impact of imbalances in Baseline levels between treatment groups on the treatment comparisons at later time points. For the O'Brien mean rank analysis at a particular time point, adjusted HbA1c values (for both treatment groups together) and adjusted mean daily insulin use values was ranked from smallest to largest. For each participant, the HbA1c and insulin use ranks were added together, producing a composite rank. A treatment comparison test was then performed on the composite ranks. If otelixizumab treatment was effective on this composite endpoint, then the mean of the ranks sum in the otelixizumab group was smaller than the mean of the ranks sum in the placebo group.|Month 6 and 12|ITT population. Only those participants available at the indicated time points were analyzed.||Rank||Standard Deviation|Mean
818946|NCT01128894|Secondary|Number of Participants Who Achieved HbA1c Response Level of <6.5% and <7.0% at Week 32|Number of participants who achieved HbA1c response levels of <6.5% and <7.0% at Week 32 were assessed. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Week 32|ITT Population. Only those participants available at the indicated time point were assessed.||Participants|||Number
818925|NCT01123083|Secondary|Percentage of Participants With Change From Baseline in Severe Hypoglycemic Events and Documented Symptomatic Hypoglycemic Events at Month 12|Severe hypoglycemia was considered as an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. These episodes may be associated with sufficient neuroglycopenia to induce seizure or coma. Plasma glucose measurements may not be available during such an event, but neurological recovery attributable to the restoration of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. Documented symptomatic hypoglycemia was considered as an event during which typical symptoms of hypoglycemia are accompanied by a measured plasma glucose concentration less than or equal to 70 mg/dL and it was collected in (1) eCRF using two forms – for single event and for mutiple events, and (2) the IVRS system. The percentage of participant with incidence of severe hypoglycemia and documented symptomatic hypoglycemia have been reported.|Baseline (Day 1) and Month 12|ITT population.||Percentage of participants|||Number
818926|NCT01123083|Secondary|Average Number of Severe Hypoglycemic Events and Documented Symptomatic Hypoglycemic Events From Baseline to Month 12|Severe hypoglycemia was considered as an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. These episodes may be associated with sufficient neuroglycopenia to induce seizure or coma. Plasma glucose measurements may not be available during such an event, but neurological recovery attributable to the restoration of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. Documented symptomatic hypoglycemia was considered as an event during which typical symptoms of hypoglycemia are accompanied by a measured plasma glucose concentration less than or equal to 70 mg/dL and it was collected in (1) eCRF using two forms – for single event and for mutiple events, and (2) the IVRS system. The numbers of participant-reported hypoglycemic events per participant of severe hypoglycemia and documented symptomatic hypoglycemia have been reported.|Baseline (Day 1) and Month 12|ITT population.||Events|||Number
818927|NCT01123083|Secondary|Change From Baseline in HbA1c Levels Over 7 Consecutive Days During the 2 Weeks Prior to the Assessment|HbA1c level was recorded at Baseline, Month 3, 6 and 12. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post Baseline value from the Baseline value.|Baseline (Day 1) and Month 3, 6, 12|ITT population. Only those participants available at the indicated time points were analyzed.||Percentage of HbA1c||Standard Error|Least Squares Mean
818928|NCT01123083|Secondary|Change From Baseline in Mean Daily Insulin Use Over 7 Consecutive Days During the 2 Weeks Prior to the Assessment|Mean daily insulin use over 7 consecutive days during the 2 weeks preceding each key visit was calculated as the mean of the values of amount of insulin used per day on each of the 7 consecutive days. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post Baseline value from the Baseline value.|Baseline (Day 1) and Month 3, 6, 12|ITT population. Only those participants available at the indicated time points were analyzed.||International unit per kilogram (IU/kg)||Standard Error|Least Squares Mean
818929|NCT01123083|Secondary|Number of Participants With Responder Status|A participant was considered a responder when, at the given time point, the participant had: glycosylated hemoglobin (HbA1c) less than or equal to 6.5 percent and mean daily insulin use less than 0.5 international unit per kilogram per day (IU/kg/day) over 7 consecutive days during the 2 weeks preceding the visit.|Month 3, 6 and 12|ITT population. Only those participants available at the indicated time points were analyzed.||Participants|||Count of Participants
818930|NCT01123083|Secondary|Change From Baseline in Stimulated C-Peptide Mean AUC at Week 12, Month 6, 12 and 18|C-peptide is a protein that shows how much insulin the body is producing. For 3 days before the mixed meal tolerance test participants were asked to eat a balanced diet. The test was performed only when the finger-stick blood glucose level was above 70 mg/dL and no higher than 200 mg/dL. Mixed meal-stimulated C-peptide AUC was the area under the C-peptide/time curve from time 0 to 120-minutes, calculated using the trapezoidal rule. This AUC was normalized for time interval by dividing it by 120-minutes (the number of minutes over which it was determined), and was adjusted by inclusion of Baseline C-peptide AUC as a covariate in the analysis. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post Baseline value from the Baseline value.|Baseline (Day 1) and Week 12, Month 6, 12, 18|ITT population. Only those participants available at the indicated time points were analyzed.||nanomoles per liter||Standard Deviation|Mean
818931|NCT01123083|Secondary|Change From Baseline in 2 Hour Mixed Meal-stimulated C-peptide AUC (Normalized for 120-minute Time Interval) at Week 12 and 6 Months|C-peptide is a protein that shows how much insulin the body is producing. For 3 days before the mixed meal tolerance test participants were asked to eat a balanced diet. The test was performed only when the finger-stick blood glucose level was above 70 mg/dL and no higher than 200 mg/dL. Mixed meal-stimulated C-peptide AUC was the area under the C-peptide/time curve from time 0 to 120-minutes, calculated using the trapezoidal rule. This AUC was normalized for time interval by dividing it by 120-minutes (the number of minutes over which it was determined), and was adjusted by inclusion of Baseline C-peptide AUC as a covariate in the analysis. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post Baseline value from the Baseline value.|Baseline (Day 1) and Week 12, Month 6|ITT population. Only those participants available at the indicated time points were analyzed.||nanomoles per liter||Standard Error|Least Squares Mean
818932|NCT01123083|Primary|Change From Baseline in 2 Hour Mixed Meal-stimulated C-peptide Area Under Curve (AUC) (Normalized for 120-minute Time Interval) at Month 12|C-peptide is a protein that shows how much insulin the body is producing. For 3 days before the mixed meal tolerance test participants were asked to eat a balanced diet. The test was performed only when the finger-stick blood glucose level was above 70 mg per deciliter (mg/dL) and no higher than 200 mg/dL. Mixed meal-stimulated C-peptide AUC was the area under the C-peptide/time curve from time 0 to 120-minutes, calculated using the trapezoidal rule. This AUC was normalized for time interval by dividing it by 120-minutes (the number of minutes over which it was determined), and was adjusted by inclusion of Baseline C-peptide AUC as a covariate in the analysis. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the value at Month 12 from the Baseline value.|Baseline (Day 1) and Month 12|ITT population consisted of all participants who were randomized and received any part of at least 1 infusion of study drug. Only those participants available at the indicated time points were analyzed.||nanomoles per liter||Standard Error|Least Squares Mean
818933|NCT01123148|Primary|The Accuracy of BCI Typing While Tilting in a Power Wheelchair and While Sitting Still in a Power Wheelchair.|"Subjects will participate in 3 sessions. During each session each subject will copy a word in each of 3 conditions (no-movement, self-movement, continuous movement) by typing using only brainwaves. For the no-movement condition, the wheelchair seat remains in a fixed position. For the self-movement condition, the angle of the wheelchair seat changes in response to some of the selections made with the brain-computer interface. For the continuous movement condition, the angle of the wheelchair seat moves continuously. Changes in the wheelchair's position may affect spelling accuracy. The accuracy of the subject's copy spelling of the designated word will be measured for each condition in each session. The order of the conditions is balanced across the three days. The accuracy for each subject in each condition is presented as the average of the accuracies for that condition across the three days."|3 1-2 hour sessions over 2-4 weeks|||% Accuracy of selections||Standard Deviation|Mean
818934|NCT01123161|Secondary|NIHSS Scores at 90 Days|The National Institutes of Health Stroke Scale (NIHSS) is used to quantify neurological deficit. The scale ranges from 0 (best) to 42 points (worst). Between scores of 0 to 42, higher values reflect progressively greater deficit.|90 days|Intention to treat patients with an available 90-day NIHSS values therefore the total numbers available are fewer than the total ITT population.||units on a scale||Standard Deviation|Mean
818935|NCT01123161|Secondary|The Barthel Index Measure of Activities of Daily Living;|The Barthel index measures independence in activities of daily living from 0 (worst) to 100 (best) in 5 point increments. Higher scores between 0 and 100 reflect progressively greater levels of independence. Scores were dichotomized at 90 so that a score of 95 or 100 was considered a successful treatment.|90 days|The intention to treat population with a 90-day Barthel index available was used, therefore the numbers are fewer than in the total population.||participants|||Number
818936|NCT01123161|Primary|90 Day Mortality|Mortality prior to the 90-day evaluation.|90 days|ITT population||participants|||Number
818937|NCT01123161|Primary|Incidence of Pneumonia|Number subjects diagnosed with pneumonia according to CDC criteria will be presented by treatment group and overall, regardless of seriousness|7 days or discharge whichever comes first|ITT population||participants|||Number
818938|NCT01123161|Primary|Incidence of Any Symptomatic Intracranial Hemorrhage (sICH) Within 48 Hours of Stroke Onset|Incidence (number) of Symptomatic ICH (sICH) within 48 hours of stroke onset will be presented by treatment group and overall. Patients with neuroworsening (4 or more point increase in NIHSS , or a decline in the NIHSS consciousness item 1A score of more than 1 point, or a motor deterioration lasting more than 8 hours, all not due to iatrogenic cause) and hemorrhage seen on brain images in whom the investigator attributes the clinical change to the hemorrhage.|48 hours|ITT patients in whom a brain image was obtained 36 yo 48 hours after treatment||participants|||Number
818939|NCT01123161|Primary|Incidence of Any Intracranial Hemorrhage (ICH) Within 48 Hours of Stroke Onset|Incidence (number) of any intracranial hemorrhage (ICH) (whether or not symptomatic) within 48 hours of stroke onset will be presented by treatment group and overall.|48 hours|Intention to treat patients with imaging obtained 36 to 48 hours after treatment||participants|||Number
818940|NCT01123161|Primary|The Primary Outcome is the Proportion of Patients Achieving a Favorable Outcome Defined as Modified Rankin Scale Score of 0 or 1, Assessed 90 Days After Treatment.|Modified Rankin describes disability: 0 is free of any disability or symptoms, 6 is death, and higher grades between 0 and 6 reflect progressively greater disability|90 days|Intention to Treat Population||participants|||Number
818941|NCT01123200|Secondary|Changes in Accuracy of BCI for Controlling Devices and Text|Changes in Accuracy Percentage (i.e., cumulative correct selections per month divided by the cumulative number of intended sections per month). Looking for trends over each 6 month period.|6 months, 12 months, 18 months|The first six month period was not completed by any participant so accuracy data for six months could not be analyzed.|||||
818942|NCT01123200|Primary|Duration of BCI Usage by Persons With ALS.|Number of months of BCI usage by each participant.|Monthly measurements for a period of up to 18 months.|||months||Full Range|Mean
818943|NCT01128829|Primary|The Effect of Sucralose on Insulin Concentration (Area Under the Curve; AUC)|we will measure plasma insulin concentrations during a 5-hour modified Oral Glucose Tolerance Test (mOGTT) administered 10 minutes after subjects consume sucralose in water or an equal volume of water without sucralose (control condition).Plasma insulin concentrations were measured at 20, 15, 10, 6, and 2 min before and at 10, 20, 30, 40, 60, 90, 120, 150,180, 240, and 300 min after ingesting 75g of glucose. All these data collected were used to create the AUC curve.|Baseline|||(pmol • min •L-1)||Standard Deviation|Mean
818944|NCT01128894|Secondary|Mean Change From Baseline in Body Weight at Week 32|The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the value at Week 32 minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with treatment group, region, Baseline HbA1c category, history of prior myocardial infarction (yes versus no), and age category (<65 years versus ≥65 years) as factors and Baseline weight as a continuous covariate. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Weight values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values.|Baseline and Week 32|ITT Population. Only those participants available at the indicated time point were assessed.||Kilograms||Standard Deviation|Mean
818945|NCT01128894|Secondary|Time to Hyperglycemia Rescue at Week 32|Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue. The conditions for hyperglycemia rescue were as follows: fasting plasma glucose (FPG) >=280 milligram/decilitre (mg/dL) >= Week 2 and < Week 4, FPG >=250 mg/dL >= Week 4 and <Week 12, HbA1c ≥8.5% and ≤0.5% reduction from Baseline- >= Week 12 and <Week 26, or HbA1c ≥8.5% >= Week 26. Time to hyperglycemia rescue is defined as the time between the date of the first dose of study medication and the date of hyperglycemia rescue plus one day, or the time between the date of the first dose of study medication and the date of the last visit during the active treatment period plus one day for participants not requiring rescue. This time was divided by 7 to express the result in weeks. All times extending beyond Week 32 relevant to hyperglycemia rescue were censored at Week 32.|Week 32|ITT Population||Weeks||95% Confidence Interval|Median
818947|NCT01128894|Secondary|Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 3, 4, 6, 12, 18 and 26|The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were considered in the treatment week if they had received at least one dose in that treatment week.|Baseline, Weeks 1, 2, 3, 4, 6, 12, 18 and 26|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Millimoles per liter (mmol/L)||Standard Deviation|Mean
818948|NCT01128894|Secondary|Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 32|The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with treatment group, region, Baseline HbA1c category, history of prior myocardial infarction (yes versus no), and age category (<65 years versus ≥65 years) as factors and Baseline FPG as a continuous covariate. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were considered in the treatment week if they had received at least one dose in that treatment week.|Baseline and Week 32|ITT Population. Only those participants available at the indicated time point were assessed.||Millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
818949|NCT01128894|Secondary|Mean Change From Baseline in HbA1c at Weeks 4, 6, 12, 18 and 26|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were considered in the treatment week if they had received at least one dose in that treatment week.|Baseline, Weeks 4, 6, 12, 18 and 26|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Percentage of HbA1c in the blood||Standard Deviation|Mean
818950|NCT01128894|Primary|Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 32|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline in HbA1c was calculated as the value at Week 32 minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with treatment group, region, history of prior myocardial infarction (yes versus no), and age category (<65 years versus ≥65 years) as factors and Baseline HbA1c as a continuous covariate. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Baseline and Week 32|Intent-to-Treat (ITT) Population: all participants who received at least one dose of study medication and who had at least one post-Baseline assessment of the primary endpoint, HbA1c. Only those participants available at the indicated time point were assessed.||Percentage of HbA1c in the blood||Standard Error|Least Squares Mean
818951|NCT01128946|Secondary|Change From Baseline in Enamel Fluoride Uptake Upon Exposure to NaF Toothpaste (1450ppmF), SnF/NaF Toothpaste (1450ppmF), NaMFP/NaF Toothpaste (1450ppmF) and NaF Toothpaste (675ppmF)|Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on the amount of fluoride (F) divided by the area of the enamel cores. The difference between treatments was calculated with respect to fluoride uptake by enamel.|Baseline to 14 days|PP population: All randomized participants, who received at least one dose of study treatment and with at least one post-baseline efficacy assessment but did not have any major protocol violations. Missing data was not imputed. Due to drop outs, there were differences in number of participants (N) per treatment group.||micrograms (μg)*F/centimeters(cm)^2]||Standard Error|Mean
818952|NCT01128946|Secondary|%SMHR of Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), SnF/NaF Toothpaste (1450ppmF), NaMFP/NaF Toothpaste (1450ppmF) and NaF Toothpaste (675ppmF)|SMH test was used to assess mineral status of partially demineralized enamel specimens using Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening/demineralization, while decrease in the indentation represents rehardening/ remineralization of enamel surface. Percent SMH recovery was calculated from indentation values of enamel specimens at baseline(B), after intra-oral exposure(R) and after in-vitro demineralization(D) using formula: [(D-R)/ (D-B)]*100.|Baseline to 14 days|PP population: All randomized participants, who received at least one dose of study treatment and with at least one post-baseline efficacy assessment but did not have any major protocol violations. Missing data was not imputed. Due to drop outs, there were differences in number of participants (N) per treatment group||Percentage||Standard Error|Mean
818973|NCT01129115|Primary|Change in Maximal Oxygen Consumption|Maximal Oxygen consumption (VO2 max) is the standard, quantitative measure of aerobic fitness. The physiologic range of scores is approximately 3.5 milliliters of oxygen per kilogram of body weight per minute (ml/kg/min) to approximately 90 (ml/kg/min). Higher numbers indicate greater fitness and positive change indicates increasing fitness. Lower number indicate worse fitness|26 weeks|||ml/kg/min||Standard Deviation|Mean
818953|NCT01128946|Primary|Percentage Surface Microhardness Recovery (%SMHR) of Enamel Specimens Exposed to NaF Toothpaste (1450ppmF) and SnF/NaF Toothpaste (1450ppmF)|SMH test was used to assess mineral status of partially demineralized enamel specimens using Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening/demineralization, while decrease in the indentation represents rehardening/ remineralization of enamel surface. Percent SMH recovery was calculated from indentation values of enamel specimens at baseline(B), after intra-oral exposure(R) and after in-vitro demineralization(D) using formula: [(D-R)/(D-B)]*100.|Baseline to 14 days|Per Protocol (PP) population: All randomized participants, who received at least one dose of study treatment and with at least one post-baseline efficacy assessment but did not have any major protocol violations. Missing data was not imputed. Due to drop outs, there were differences in number of participants (N) per treatment group.||Percentage of SMHR||Standard Error|Mean
818954|NCT01128959|Primary|Adverse Events||Baseline to after last iv dose on day 4|All Patients Treated Set||Number of adverse events|||Number
818955|NCT01128972|Other Pre-specified|Adjusted Mean Percent SMH Recovery of Enamel Specimens Exposed to Test Dentifrice +Sterile Water Rinse and Reference Dentifrice +Sterile Water Rinse|SMH test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMH recovery was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: [(E1-R)/ (E1-B)]*100.|Baseline, 4 hours post treatment in each treatment period|PP population: All randomized subjects who received at least one dose of the study treatments and had no major protocol deviations were included in analysis.||Percent SMH||Standard Error|Least Squares Mean
818956|NCT01128972|Other Pre-specified|Adjusted Mean Percent NER of Enamel Specimens Exposed to Test Dentifrice +Sterile Water Rinse and Reference Dentifrice +Sterile Water Rinse|Enamel specimens were exposed to dietary erosive challenge and set of five indentations within each specimen was measured. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine NER which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent NER was calculated by formula: [(E1-E2)/ (E1-B)]*100. Smaller the negative NER, better is treatment regimen in imparting resistance to enamel.|Baseline, 4 hours post treatment in each treatment period|PP population: All randomized subjects who received at least one dose of the study treatments and had no major protocol deviations were included in analysis.||Percent NER||Standard Error|Least Squares Mean
818957|NCT01128972|Other Pre-specified|Adjusted Mean Percentage SMH Recovery of Enamel Specimens Exposed to Test Dentifrice + Test MR Relative to Following Treatment Regimens: 1) Test Dentifrice +Test MR 2) Test Dentifrice + Sterile Water 3) Reference Dentifrice +Sterile Water|SMH test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMH recovery was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: [(E1-R)/ (E1-B)]*100.|Baseline, 4 hours post treatment in each treatment period|PP population: All randomized participants who received at least one dose of the study treatments and had no major protocol deviations were included in analysis.||Percent SMH||Standard Error|Least Squares Mean
818958|NCT01128972|Other Pre-specified|Adjusted Mean Percent NER of Enamel Specimens Exposed to a Treatment Regimen of Placebo Dentifrice + Test MR Relative to: 1) Test Dentifrice +Test MR 2) Test Dentifrice + Sterile Water Rinse 3) Reference Dentifrice +Sterile Water Rinse|Enamel specimens were exposed to dietary erosive challenge and set of five indentations within each specimen was measured. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine NER which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent NER was calculated by formula: [(E1-E2)/ (E1-B)]*100. Smaller the negative NER, better is treatment regimen in imparting resistance to enamel.|Baseline, 4 hours post treatment in each treatment period|PP population: All randomized subjects who received at least one dose of the study treatments and had no major protocol deviations were included in analysis.||Percent NER||Standard Error|Least Squares Mean
818959|NCT01128972|Secondary|Adjusted Mean Percentage Surface Microhardness (SMH) Recovery of Enamel Specimens Exposed to Test Dentifrice + Test MR Relative to: 1)Test Dentifrice+Sterile Water Rinse 2)Reference Dentifrice+Sterile Water Rinse 3)Placebo Dentifrice+ Sterile Water Rinse|SMH test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMH recovery was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: [(E1-R)/ (E1-B)]*100.|Baseline, 4 hours post treatment in each treatment period.|PP population: All randomized participants who received at least one dose of the study treatments and had no major protocol deviations were included in analysis.||Percent SMH||Standard Error|Least Squares Mean
818960|NCT01128972|Primary|Adjusted Mean Percent Net Erosion Resistance (NER) of Enamel Specimens Exposed to Test Dentifrice + Test MR Relative to: 1) Test Dentifrice+ Sterile Water Rinse 2) Reference Dentifrice+ Sterile Water Rinse 3) Placebo Dentifrice+ Sterile Water Rinse|Enamel specimens were exposed to dietary erosive challenge and set of five indentations within each specimen was measured. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine NER which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent NER was calculated by formula: [(E1-E2)/ (E1-B)]*100. Smaller the negative NER, better is treatment regimen in imparting resistance to enamel.|Baseline, 4 hours post treatment in each treatment period|Per protocol (PP) population: All randomized subjects who received at least one dose of the study treatments and had no major protocol deviations were included in analysis.||Percent NER||Standard Error|Least Squares Mean
818961|NCT01129011|Secondary|Mean Change From Baseline on Satisfaction of the Severity of Dyspepsia Assessment (SODA) Subscales|Mean Change in Satisfaction on SODA Assessment. Questions/statements to rate about satisfaction/dissatisfaction with their present level of abdominal discomfort. Question 1: 4-point scale range 0 (extremely unhappy) to 4 (extremely happy), statement 2 (I feel satisfied with my health with regard to abdominal discomfort) & statement 3 (I am pleased because my abdominal discomfort seems under control) on a 5 point scale (definitely true to definitely false) & question 4 rated how pleased subjects were with abdominal discomfort on a 10 point scale. Total satisfaction composite range: 2-23|baseline to 6 Months|Intent to Treat (ITT) Population||Units on SODA Subscale||Standard Error|Least Squares Mean
818962|NCT01129011|Secondary|Mean Change From Baseline on Non-Pain Symptoms of the Severity of Dyspepsia Assessment (SODA) Subscales|Change from Baseline of Non-Pain Symptoms on the SODA Assessment. There are 7 categories about the non-pain symptoms: burping/beching, heartburn, bloating, passing gas, sour taste, nausea and bad breath. For each of these categories, subjects were to rate during the past seven days, on average, the severity on a 5 point scale ranging from no problem to very severe problem. The scores are combined into a single composite score. The total possible range of the non-pain symptoms subscale is: 7-35.|baseline to 6 Months|Intent to Treat (ITT) Population||Units on SODA Subscale||Standard Error|Least Squares Mean
818963|NCT01129011|Secondary|Mean Change From Baseline on Pain Intensity of the Severity of Dyspepsia Assessment (SODA) Subscales|"Mean Change from Baseline on Pain Intensity of the Severity of Dyspepsia Assessment (SODA) Subscales. There are 6 questions about abdominal pain during the past 7 days: q 1-5 on average: 1. rate with a number between 0 (no pain) and 100 (pain as bad as it could be), 2. rate with a number between 0 (no discomfort) and 10 (discomfort as bad as it can be), 3. on a scale of 5 (from none to excriciating), 4. on 100 mm VAS, 5. on a scale of 4 and 6. worst abdominal pain scale 0 (no discomfort) and 10 (discomfort as bad as it can be). Total composite possible range for pain intensity is: 2-47"|Baseline to 6 Months|Intent to Treat (ITT) Population||Units on SODA Subscale||Standard Error|Least Squares Mean
818964|NCT01129011|Secondary|Improvement From Baseline in Upper Abdominal Pain and Discomfort Scores at 6 Months, Based on the Overall Treatment Evaluation for Dyspepsia Questionnaire|"Improvement from baseline in Upper Abdominal Pain and Discomfort scores at 6 months, based on the overall Treatment Evaluation for Dyspepsia Questionnaire. Subjects were asked: since treatment started, has there been any change in your upper abdominal pain and/or discomfort? Answers would be better/about the same/worse. Participants with the response better (instead of about the same or worse), are tabulated by treatment group."|change from baseline at 6 Months|Intent to Treat Population||Participants|||Number
818965|NCT01129011|Secondary|Heartburn Symptom Resolution, ie no Heartburn Symptoms During the Last 7 Days Prior to the Visit|"Subjects were asked whether heartburn symptoms within the 7 days prior to the visit were:
none: no symptoms
mild: awareness of symptom, but easily tolerated
moderate: discomforting symptom sufficient to cause interference with normal activities (including sleep)
severe: incapacitating symptom, with inability to perform normal activities (including sleep) Heartburn was defined as a burning feeling rising from the stomach or lower part of the chest towards the neck."|6 months|Intent to Treat (ITT) Population||participants|||Number
818966|NCT01129011|Secondary|The Number of Participants Developing Duodenal Ulcers Throughout 6 Months of Treatment|The Number of Participants Developing Duodenal Ulcers at any time during the 6 Months of the treatment period|6 months|Intent to treat (ITT) population||Participants|||Number
818967|NCT01129011|Secondary|The Number of Participants Discontinuing From the Study Due to NSAID-Associated Upper GI Adverse Events or to Duodenal Ulcer|The Number of Participants Discontinuing from the Study Due to non-steroidal antiinflammatory drug (NSAID)-Associated Upper GI Adverse Events or to Duodenal Ulcer during the treatment period|6 Months|Intent to Treat (ITT) Population||Participants|||Number
818968|NCT01129011|Secondary|The Number of Participants With Pre-Specified NSAID-Associated Upper GI Adverse Events or Duodenal Ulcers|The Number of Participants with Pre-Specified non-steroidal antiinflammatory drug (NSAID)-Associated Upper Gastrointestinal (UGI) Adverse Events or Duodenal Ulcers after 6 months of treatment. Pre-specified UGI adverse events typically associated with NSAID use include dyspepsia, abdominal pain, gastritis, erosive esophagitis, duodenitis, abdominal discomfort|6 months|Intent to Treat (ITT) Population||Participants|||Number
818969|NCT01129011|Primary|Number of Participants With Gastric Ulcer Confirmed by Endoscopy|The primary efficacy endpoint was the number of subjects with gastric ulcers at any time throughout 6 months of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter (measured by close application of open endoscopic biopsy forceps) with unequivocal crater depth. A subject is considered to have completed the study if all scheduled assessments up through the 6 month visit have been performed or if the endpoint of gastric ulcer confirmed by endoscopy has been reached.|6 months|Intent to Treat (ITT) Population||Participants|||Number
818970|NCT01129102|Secondary|Difference in the VAS of Primary Dysmenorrhea (Baseline/Pretreatment-End of Treatment)|VAS stands for Visual Analogue Scale of pain. The scale was rated as a graphic rating scale. as a 100mm baseline from 0:No pain to 100:Worst possible pain.|16weeks|This analysis was carried out based on FAS population. IKH-01 was not allocated for primary dysmenorrhea in this study. Therefore, VAS for primary dysmenorrhea is not available in IKH-01 group.||units on a scale||Standard Deviation|Mean
818971|NCT01129102|Primary|Patient Response to Treatment for Dysmenorrhea, as Evaluated by Difference of Total Dysmenorrhea Score (Baseline/Pretreatment-End of Treatment)|"The detail of dysmenorrhea score that was used in this study is the following. These subscales summed for a total dysmenorrhea score (minimum 0 to maximum 6). Pain score None 0 : None Mild 1 : There are some troubles for work Moderate 2 : Needing to rest in bed and/or affecting work Severe 3 : Morre than 1 day in bed and not possible to work
Drug score (during a menstrual period) None 0 : None Mild 1 : taking analgesics for 1 days Moderate 2 : taking analgesics for 2 days Severe 3 : taking analgesics more than 3 days"|16weeks|Primary endpoints were analysed based on FAS population. Data unavailable for IKH-01 group because IKH-01 group only assigned for secondary dysmenorrhea.||units on a scale||Standard Deviation|Mean
818972|NCT01129115|Primary|Change in Physical Performance Test|The Physical Performance Test is a 9-item measure of physical function. The range of scores is 0-34. Higher numbers indicate better physical function. Positive change indicates improving function. Negative change indicates decreasing function.|26 Week|||units on a scale||Standard Deviation|Mean
818974|NCT01129115|Secondary|Reasoning|"Reasoning is a latent derived variable derived estimated mean. The reported latent means for this trial are created from the well-known neuropsychological tests:Letter and Word Inductive Reasoning, Matrix Reasoning.
Latent variables cannot be measured directly but are derived from a theory-driven confirmatory factor analysis in a structural equation model framework. The latent scores are centered around a mean of 0 and standardized so each value represents a fraction of the standard deviation. There are no limits to the scores. Positive number indicate improved performance. Negative numbers indicate worsening performance."|26 Weeks|||units on a scale||Standard Error|Mean
818975|NCT01129115|Secondary|Set Maintenance & Shifting|"Set Maintenance and Switching is a latent derived variable derived estimated mean. The reported latent means for this trial are created from the well-known neuropsychological tests: DKEFS Card Sort, Animal and Vegetable Category Fluency.
Latent variables cannot be measured directly but are derived from a theory-driven confirmatory factor analysis in a structural equation model framework. The latent scores are centered around a mean of 0 and standardized so each value represents a fraction of the standard deviation. There are no limits to the scores. Positive number indicate improved performance. Negative numbers indicate worsening performance."|26 Weeks|||units on a scale||Standard Error|Mean
818976|NCT01129115|Secondary|Simple Attention|"Simple Attention is a latent derived variable derived estimated mean. The reported latent means for this trial are created from the well-known neuropsychological tests: Digit span Forward and Backward, Letter Numbers Sequencing.
Latent variables cannot be measured directly but are derived from a theory-driven confirmatory factor analysis in a structural equation model framework. The latent scores are centered around a mean of 0 and standardized so each value represents a fraction of the standard deviation. There are no limits to the scores. Positive number indicate improved performance. Negative numbers indicate worsening performance."|26 Weeks|||units on a scale||Standard Error|Mean
818977|NCT01129115|Primary|Visuospatial Processing|"Visuospatial Processing is a latent derived variable derived estimated mean.The reported latent means for this trial are created from the well-known neuropsychological tests: Block Design, Stroop Color Reading, Digit Symbol Substitution and Trailmaking Test A.
Latent variables cannot be measured directly but are derived from a theory-driven confirmatory factor analysis in a structural equation model framework. The latent scores are centered around a mean of 0 and standardized so each value represents a fraction of the standard deviation. There are no limits to the scores. Positive number indicate improved performance. Negative numbers indicate worsening performance."|26 weeks|||units on a scale||Standard Error|Mean
818978|NCT01129115|Secondary|Verbal Memory|"Verbal Memory is a latent derived variable derived estimated mean. The reported latent means for this trial are created from the well-known neuropsychological tests: Logical Memory, Delayed Logical Memory, Selective Reminding Task - Free Recall Total, Boston Naming Test.
Latent variables cannot be measured directly but are derived from a theory-driven confirmatory factor analysis in a structural equation model framework. The latent scores are centered around a mean of 0 and standardized so each value represents a fraction of the standard deviation. There are no limits to the scores. Positive number indicate improved performance.Negative numbers indicate worsening performance."|26 weeks|Healthy older adults without measurable cognitive decline who did not meet recommended daily activity levels.||units on a standardized scale||Standard Error|Mean
818979|NCT01129128|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Adverse events such as nausea or rash in participants receiving an Echinacea formulation or placebo will be compared|1- 30 days after starting study medication|Participants who received at least one dose of study medication||participants|||Number
818980|NCT01129128|Secondary|Peak Level IL-2|Highest level of IL-2 while taking study medication|1-10 days after starting study medication|Data analyzed on any participant who IL-2 level was obtained on 1 or more days while on study medication.||pg/ml||Standard Deviation|Mean
818981|NCT01129128|Secondary|Peak Level Interferon Gamma|Highest level of Interferon gamma while taking study medication|1-10 days after starting study medication|Data analyzed on any participant who Interferon gamma level was obtained on 1 or more days while on study medication.||pg/ml||Standard Deviation|Mean
818982|NCT01129128|Secondary|Peak Level IL-6|Highest level of IL-6 while taking study medication|1-10 days after starting study medication|Data analyzed on any participant who IL-6 level was obtained on 1 or more days while on study medication.||pg/ml||Standard Deviation|Mean
818983|NCT01129128|Primary|Peak Level of TNF Alpha|Highest level of TNF alpha while taking study medication|1-10 days after starting study medication|Data analyzed on any participant who TNF alpha level was obtained on 1 or more days while on study medication.||pg/ml||Standard Deviation|Mean
818984|NCT01129141|Primary|Tinnitus Functional Index|The TFI served as the primary outcome measure. The TFI is a 25-item self-report questionnaire that has documented validity both for scaling the severity and negative impact of tinnitus, and for measuring treatment-related changes in tinnitus (responsiveness) (Meikle et al., 2012). The total score for the TFI ranges from 0 to 100, with higher scores indicating greater problems with tinnitus. The TFI has excellent internal consistency (Cronbach’s α = .97) and high test-retest reliability (r = .86) (Meikle et al., 2012). The authors of the TFI estimated that a 13-point decrease on the TFI for an individual is likely to reflect a change that feels meaningful to the person.|Baseline, 6 months|||units on a scale||Standard Deviation|Mean
818985|NCT01131884|Primary|Bone Mineral Density|Whether or not Fosamax increases bone mineral density at the hip and distal femur in spinal cord injury induced osteoporosis|1 year after enrollment|No analysis performed as there was only one patient who participated in this study|||||
818986|NCT01132118|Secondary|Triglycerides|mg/dL|Baseline and Week 8|||mg/dL||Standard Deviation|Mean
818987|NCT01132118|Secondary|HDL Cholesterol|mg/dL|Baseline and Week 8|||mg/dL||Standard Deviation|Mean
818988|NCT01132118|Secondary|LDL Cholesterol|mg/dL|Baseline and Week 8|||mg/dL||Standard Deviation|Mean
818989|NCT01132118|Secondary|Total Cholesterol|mg/dL|Baseline and Week 8|||mg/dL||Standard Deviation|Mean
818990|NCT01132118|Secondary|HOMA-B|HOMA-B = (360 x Insulin)/(Glucose - 63)|Baseline and Week 8|||(mIU x dL)/(L x mg)||Standard Deviation|Mean
818991|NCT01132118|Secondary|HOMA-IR|"We will examine the effect of HCQ on HOMA-IR during the active treatment phase compared with placebo phase.
HOMA-IR = (Glucose x insulin)/405"|Baseline and Week 8|||(mg x mIU)/(dL*L)||Standard Deviation|Mean
819015|NCT01132495|Primary|Major Adverse Cardiac Event Rate (MACE)|MACE: A composite of all cause death, documented MI, unplanned hospitalization leading to urgent revascularization.|24 Month|The primary outcome analysis was designed for Cohort A only.||percentage of subjects with SAEs|||Number
818993|NCT01132144|Secondary|Procedure Related Pain|"Pain will be assessed using a Visual Analogue Scale (VAS). We will use a 10 cm length horizontal line, anchored by word descriptors at each end: No Pain = 0 cm and Very Severe Pain = 10 cm.
This outcome will be assessed in both groups, just after endometrial injury or sham procedure."|Immediately after procedure|All women enrolled.||cm||Standard Deviation|Mean
818994|NCT01132144|Secondary|Three-dimensional Doppler Indices From Endometrium (VFI)|"Vascularization index (VI), flow index (FI) and vascularization-flow index (VFI) assessed from endometrium using three-dimensional Power Doppler ultrasonography. This outcome will be assessed when at least one follicle ≥ 17mm is observed.
Only VFI was reported as it is a combination of VI and FI (VFI = VI*FI/100), and currently there are several concerns about the validity of these indices.
Such indices have no scale."|1 month|Women that achieved at least one follicle >17mm during ovarian stimulation.||index||Standard Deviation|Mean
818995|NCT01132144|Secondary|Endometrial Volume|The total volume of endometrial tissue assessed by three-dimensional ultrasonography. This outcome will be assessed when at least one follicle ≥ 17mm is observed.|1 month|Women that achieved at least one follicle >17mm during ovarian stimulation.||cm³||Standard Deviation|Mean
818996|NCT01132144|Secondary|Endometrial Thickness|The maximum distance perpendicular to the inter-endometrial interface from the endometrium-myometrium interface of the anterior to the posterior wall of the uterus assessed in the sagittal plane. This outcome will be assessed when at least one follicle ≥ 17mm is observed.|1 month|Women that achieved at least one follicle >17mm during ovarian stimulation.||mm||Standard Deviation|Mean
818997|NCT01132144|Secondary|Implantation Rate|The number of gestational sacs observed divided by the number of embryos transferred.|3 months||||||
818998|NCT01132144|Secondary|Miscarriage|"Loss of a clinical pregnancy before 20 completed weeks of gestational age (18 weeks after fertilization).
Note: All allocated women will be considered when assessing miscarriage rate."|9 months|The number of clinical pregnancies was used as denominator, since miscarriage is a harm that can only happen in pregnant women.||Clinical pregnancies|||Number
818999|NCT01132144|Secondary|Ongoing Pregnancy|"At least one fetus with heart beat after 12 weeks of gestational age.
Note: All allocated women will be considered when assessing ongoing pregnancy rate."|6 months|||participants|||Number
819000|NCT01132144|Secondary|Clinical Pregnancy|"Pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It includes ectopic pregnancy. Multiple gestational sacs are counted as one clinical pregnancy.
Note: All allocated women will be considered when assessing clinical pregnancy rate."|3 months|All women enrolled.||participants|||Number
819001|NCT01132144|Primary|Live Birth|"The complete expulsion or extraction from its mother of a product of fertilization, irrespective of the duration of the pregnancy, which, after such separation, breathes or shows any other evidence of life, such as heart beat, umbilical cord pulsation, or definite movement of voluntary muscles, irrespective of whether the umbilical cord has been cut or the placenta is attached.
Note: All allocated women will be used as denominator when assessing live birth rate."|1 year|All women enrolled.||participants|||Number
819002|NCT01132313|Secondary|Part 3 and 4: Sustained Virological Response (SVR) at 4 Weeks After End of Treatment|Part 3 and 4: Sustained virological response (SVR) at 4 weeks after end of treatment|up to 28 weeks|FAS||Percentage of participants||95% Confidence Interval|Number
819003|NCT01132313|Secondary|Part 3 and 4: Plasma HCV RNA Level <25 IU/mL at Week 4 and 12 of Treatment|Part 3 and 4: Plasma Hepatitis C Virus Ribonucleic acid (HCV RNA) level <25 IU/mL at week 4 and 12 of treatment|Week 4 and 12|FAS||Percentage of participants|||Number
819004|NCT01132313|Secondary|Part 2: Sustained Virological Response at 4 and 24 Weeks After End of Treatment|Part 2: Sustained virological response at 4 and 24 weeks after end of treatment|4 weeks and 24 weeks after the end of treatment, up to 64 weeks|FAS||Percentage of participants|||Number
819005|NCT01132313|Secondary|Part 1 and 2: Plasma HCV RNA Level Not Detectable at Week 4|Part 1 and 2: Plasma Hepatitis C Virus Ribonucleic acid (HCV RNA) level not detectable at Week 4|4 weeks|FAS||Percentage of participants|||Number
819006|NCT01132313|Secondary|Part 2: Time to Virological Response|Part 2: Time to virological response, defined as the timepoint of the first measurement of plasma HCV RNA level <25 IU/mL. The percentage of participants who achieved virological response within each time period are displayed for this outcome measure.|From drug administration until end of drug administration, up to 40 weeks|FAS||Percentage of participants|||Number
819007|NCT01132313|Secondary|Part 1: Time to Virological Response|Part 1: Time to virological response, defined as the timepoint of the first measurement of plasma HCV RNA level <25 IU/mL. The percentage of participants who achieved virological response within each time period are displayed for this outcome measure.|From drug administration until end of drug administration, up to 4 weeks|FAS||Percentage of participants|||Number
819008|NCT01132313|Primary|Part 3 and 4: Sustained Virological Response (SVR)|Part 3 and 4: Sustained virological response (SVR) defined as HCV RNA <25IU/mL and undetectable at 12 weeks after end of treatment|From drug administration until 12 weeks after end of treatment, up to 36 weeks|FAS||Percentage of participants||95% Confidence Interval|Number
819009|NCT01132313|Primary|Part 2: Sustained Virological Response (SVR)|Part 2: Sustained virological response (SVR), defined as HCV RNA <25 IU/mL and undetectable at 12 weeks after end of treatment|From drug administration until 12 weeks after end of treatment, up to 52 weeks|FAS||Percentage of participants|||Number
819010|NCT01132313|Primary|Part 1: Rapid Virological Response (RVR)|Part 1: Rapid virological response (RVR), defined as Hepatitis C Virus Ribonucleic acid (HCV RNA) <25IU/mL at Week 4 of treatment|4 weeks|FAS which included all randomised patients who were dispensed study medication and were documented to have taken at least one dose of study medication.||Percentage of participants||95% Confidence Interval|Number
819011|NCT01132326|Primary|Patients With Treatment-emergent Adverse Events|Number of patients reporting any treatment emergent adverse events (SAE and or AEs) during the study|up to 2 years|||participants|||Number
819012|NCT01132378|Secondary|Quadriceps Strength||2 year||||||
819013|NCT01132378|Primary|Knee Society Score|The higher the score the better is the result (0-100). The knee society score reflects the outcomes and perception of the patients regarding function and pain|2 year|||score||Standard Deviation|Mean
819014|NCT01132495|Secondary|Overall MACE|Non-urgent revascularization procedures, cost and cost effectiveness, functional class, number of anti-anginal medication, rate of non-urgent revascularization, and rate of cerebrovascular event.|5 years||03/2018||||
819017|NCT01132508|Secondary|Knee Function and Stability: Extension Stability at 52 Weeks|Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.|52 weeks|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
819018|NCT01132508|Secondary|Knee Function and Stability: Extension Stability at 26 Weeks|Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.|26 weeks|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
819019|NCT01132508|Secondary|Knee Function and Stability: Extension Stability at 12 Weeks|Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.|12 weeks|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
819020|NCT01132508|Secondary|Knee Function and Stability: Extension Stability at 6 Weeks|Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.|6 weeks|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
819021|NCT01132508|Secondary|Knee Function and Stability: Extension Stability at Baseline|Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.|Baseline|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
819022|NCT01132508|Secondary|Knee Function and Stability: Total Range of Motion at 78 Weeks|Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.|78 weeks|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
819023|NCT01132508|Primary|Surgeons Overall Satisfaction With Norian Drillable|The overall satisfaction of the ease of use of Norian Drillable was rated by the surgeon.|Surgery|||Cases|||Number
819024|NCT01132508|Secondary|Knee Function and Stability: Total Range of Motion at 52 Weeks|Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.|52 weeks|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
819025|NCT01132508|Secondary|Knee Function and Stability: Total Range of Motion at 26 Weeks|Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.|26 weeks|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
819026|NCT01132508|Secondary|Knee Function and Stability: Total Range of Motion at 12 Weeks|Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.|12 weeks|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
819027|NCT01132508|Secondary|Knee Function and Stability: Total Range of Motion at 6 Weeks|Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.|6 weeks|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
819028|NCT01132508|Secondary|Knee Function and Stability: Total Range of Motion at Baseline|Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.|Baseline|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
819029|NCT01132508|Secondary|Knee Function and Stability: Extension at 78 Weeks|The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.|78 weeks|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
819030|NCT01132508|Secondary|Knee Function and Stability: Extension at 52 Weeks|The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.|52 weeks|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
819031|NCT01132508|Secondary|Knee Function and Stability: Extension at 26 Week|The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.|26 weeks|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
819032|NCT01132508|Secondary|Knee Function and Stability: Extension at 12 Weeks|The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.|12 weeks|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
819033|NCT01132508|Secondary|Knee Function and Stability: Extension at 6 Weeks|The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.|6 weeks|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
819034|NCT01132508|Secondary|Knee Function and Stability: Extension at Baseline|The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.|Baseline|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
819035|NCT01132508|Secondary|Radiographic Parameters: Angulation (Valgus/Varus) at 78 Weeks|"The anatomical grading parameter angulation (valgus/varus) (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|78 weeks|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
819036|NCT01132508|Secondary|Radiographic Parameters: Angulation (Valgus/Varus) at 52 Weeks|"The anatomical grading parameter angulation (valgus/varus) (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|52 weeks|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
819037|NCT01132508|Secondary|Radiographic Parameters: Angulation (Valgus/Varus) at 26 Weeks|"The anatomical grading parameter angulation (valgus/varus) (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|26 weeks|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
819038|NCT01132508|Secondary|Radiographic Parameters: Angulation (Valgus/Varus) at 12 Weeks|"The anatomical grading parameter angulation (valgus/varus) (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|12 weeks|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
819039|NCT01132508|Secondary|Radiographic Parameters: Angulation (Valgus/Varus) at 6 Weeks|"The anatomical grading parameter angulation (valgus/varus) (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|6 weeks|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
819040|NCT01132508|Secondary|Radiographic Parameters: Angulation (Valgus/Varus) at Surgery|"The anatomical grading parameter angulation (valgus/varus) (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|Surgery|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
819041|NCT01132508|Secondary|Radiographic Parameters: Angulation (Valgus/Varus) at Baseline|"The anatomical grading parameter angulation (valgus/varus) (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|Baseline|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
819042|NCT01132508|Secondary|Radiographic Parameters: Condylar Widening at 78 Weeks|"The anatomical grading parameter condylar widening (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|78 weeks|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
819043|NCT01132508|Secondary|Radiographic Parameters: Condylar Widening at 52 Weeks|"The anatomical grading parameter condylar widening (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|52 weeks|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
819044|NCT01132508|Secondary|Radiographic Parameters: Condylar Widening at 26 Weeks|"The anatomical grading parameter condylar widening (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|26 weeks|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
819045|NCT01132508|Secondary|Radiographic Parameters: Condylar Widening at 12 Weeks|"The anatomical grading parameter condylar widening (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|12 weeks|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
819056|NCT01132508|Primary|Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Overall Ease of Use|Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable.|Day 0 (Date of surgery)|||Cases|||Number
819046|NCT01132508|Secondary|Radiographic Parameters: Condylar Widening at 6 Weeks|"The anatomical grading parameter condylar widening (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|6 weeks|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
819047|NCT01132508|Secondary|Radiographic Parameters: Condylar Widening at Surgery|"The anatomical grading parameter condylar widening (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|Surgery|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
819048|NCT01132508|Secondary|Radiographic Parameters: Condylar Widening at Baseline|"The anatomical grading parameter condylar widening (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|Baseline|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
819049|NCT01132508|Secondary|Radiographic Parameters: Depression at 78 Weeks|"The anatomical grading parameter depression was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|78 weeks|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
819050|NCT01132508|Secondary|Radiographic Parameters:: Depression at 52 Weeks|"The anatomical grading parameter depression was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|52 weeks|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
819051|NCT01132508|Secondary|Radiographic Parameters: Depression at 26 Weeks|"The anatomical grading parameter depression was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|26 weeks|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
819052|NCT01132508|Secondary|Radiographic Parameters: Depression at 12 Weeks|"The anatomical grading parameter depression was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|12 weeks|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
819053|NCT01132508|Secondary|Radiographic Parameters: Depression at 6 Weeks|"The anatomical grading parameter depression was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|6 week|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
819054|NCT01132508|Secondary|Radiographic Parameters: Depression at Surgery|"The anatomical grading parameter depression was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|Surgery|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
819055|NCT01132508|Secondary|Radiographic Parameters: Depression at Baseline|"The anatomical grading parameter depression was assessed the following way: Anterior-Posterior (AP) and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|Baseline|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
819057|NCT01132508|Primary|Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flexibility With Surgical Procedure|Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable.|Day 0 (Date of surgery)|||Cases|||Number
819058|NCT01132508|Primary|Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flow Properties|Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable.|Day 0 (Date of surgery)|||Cases|||Number
819059|NCT01132508|Primary|Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Handling|Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable.|Day 0 (Date of surgery)|||Cases|||Number
819060|NCT01132508|Primary|Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Mixing|Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable.|Day 0 (Date of surgery)|||Cases|||Number
819061|NCT01132508|Primary|Ease of Use Score Measured With a Surgeon Questionnaire: Screw Insertion|Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer three questions about the ease of use of Norian Drillable.|Day 0 (Date of surgery)|||Cases|||Number
819062|NCT01132508|Primary|Ease of Use Score Measured With a Surgeon Questionnaire: Tap|"Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer three questions about the ease of use of Norian Drillable.
A tap is an instrument used to create threads in a hole drilled in bone."|Day 0 (Date of surgery)|||Cases|||Number
819063|NCT01132508|Primary|Ease of Use Score Measured With a Surgeon Questionnaire: K-wire|"Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer three questions about the ease of use of Norian Drillable.
Kirschner wires or K-wires are sterilized, sharpened, smooth stainless steel pins widely used to hold bone fragments together (pin fixation) or to provide an anchor for skeletal traction in fractures."|Day 0 (Date of surgery)|||Cases|||Number
819064|NCT01132508|Secondary|Pain and Function Assessed With the Lysholm Knee Scale|The Lysholm Knee Score assessed pain and function of the knee (by evaluating whether support for weight bearing was needed, the patients ability to climb stairs and to squat, whether the patients knee was instable and the patient experienced pain and swelling) and was completed by the patient before surgery and at Week 6, Week 12, Week 26, Week 52, Week 78 and Week 104 (for Australian sites only). The score ranged from 0 to 100 points with higher values indicating a better healing status of the knee.|6 weeks, 12 weeks, 26 weeks, 52 weeks, 78 weeks and 104 weeks (for Australian sites only)|Five major protocol violations were excluded in the efficacy analysis.||units on a scale||Full Range|Median
819065|NCT01132508|Primary|Ease of Use Score Measured With a Surgeon Questionnaire: Drill|Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer three questions about the ease of use of Norian Drillable.|Day 0 (Date of surgery)|||Cases|||Number
819066|NCT01132508|Primary|Number of Patients With Adverse Events as a Measure of Safety and Tolerability of the Device||At enrolment (between day -7 and day 0), day 0 (day of surgery), 6 weeks, 12 weeks, 26 weeks, 52 weeks, 78 weeks and 104 (for Australian sites only) postoperative|||participants|||Number
819067|NCT01132508|Primary|Estimate of Blood Loss in Cubic Centimeter as a Measure of Effectiveness of the Treatment|Immediately after the surgery in which Norian Drillable was implanted, the surgeon completed a questionnaire in which he recorded the estimated amount of blood loss (the amount of fluid used in irrigation should have been subtracted from the amount of fluid present in the suction canister at the completion of surgery. Any gauze used in the procedure should have been estimated for the ml of blood loss)|Day 0 (Day of surgery)|||Cubic Centimeters||Standard Deviation|Mean
819068|NCT01132508|Primary|Duration of Time the Patient Was in the OR as a Measure of Effectiveness of the Treatment|Immediately after the surgery in which Norian Drillable was implanted, the surgeon completed a questionnaire in which he recorded the duration of time the patient was in the operating room (OR)|Day 0 (Day of surgery)|||Minutes||Full Range|Median
819069|NCT01132547|Secondary|Pattern of Weight in the Study Population|Change from Baseline in Weight|Baseline and 8 weeks|Completers||Kilograms||Standard Deviation|Mean
819070|NCT01132547|Primary|Severity of Weight Loss|Change from Baseline in Weight Z score|Baseline and 8 weeks|Completers =||Z score||Standard Deviation|Mean
819071|NCT01132547|Primary|Participant With Weight Loss ≥ 5% at the 8- Week Assessment When Compared to Baseline||8 weeks|LOCF||participants|||Number
819072|NCT01132651|Secondary|Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Investigator Global Assessment (IGA) Score|The IGA score is an assessment of AD severity. It is an assessment of the patient's disease state at the time of examination and does not attempt a comparison with any of the patient's previous disease states. Possible scores range from 0 to 5. A score of 0 is associated with no evidence of AD and a score of 5 is associated with severe AD.|Baseline and at 2 weeks|||units on a scale||Inter-Quartile Range|Median
819073|NCT01132651|Primary|Change in Sleep Quality as Measured by a Change in Pittsburgh Sleep Quality Index (PSQI) Survey Score|"The PSQI is a clinical survey used to measure sleep quality. Seven components related to sleep quality are scored: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction. Each component is scored on a scale of 0 to 3. A score of 0 is associated with better sleep quality and a score of 3 is associated with worse sleep quality. The seven component scores are summed to achieve a total PSQI score. The total PSQI score has a range of 0-21. A score of 0 is associated with better sleep quality and a score of 21 is associated with worse sleep quality.
Buysse,D.J., Reynolds,C.F., Monk,T.H., Berman,S.R., & Kupfer,D.J. (1989). The Pittsburgh Sleep Quality Index (PSQI): A new instrument for psychiatric research and practice. Psychiatry Research, 28(2), 193-213."|Baseline and at 2 weeks|||units on a scale||Inter-Quartile Range|Median
819074|NCT01132664|Secondary|Progression Free Survival (PFS) - Based on Investigator Review Using Kaplan Meier - Phase l & ll||18 months|FAS consisted of all patients who received at least 1 dose of study drug (buparlisib). PFS analysis was not done for the BM cohort population. MTD/RP2D was not established due to premature termination of the study. In the phase ll portion of the study, PFS was analyzed only in patients with known PIK3 status, thus only 26/50 patients were analyzed.||Months||90% Confidence Interval|Median
819075|NCT01132664|Secondary|Clinical Benefit Rate (CBR) - Phase l & ll|"CBR = patients with CR, PR or SD ≥ 24 weeks according to RECIST by the investigator.
Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0 assessed the disease status by imaging (i.e. CT/MRI): CR = Disappearance of all tumor lesions; PR= >=30% shrinkage of lesions; SD = Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD; PD = At least a 20% increase in the sum of the longest diameter of all measured target lesions, taking as reference the smallest sum of longest diameter of all target lesions recorded at or after baseline."|18 months|"The full analysis set (FAS) consisted of all patients who received at least one dose of study drug (buparlisib).
CBR analysis was not done for the BM cohort population."||Participants|||Number
819076|NCT01132664|Secondary|Disease Control Rate (DCR) Based on Investigator Assessment- Phase l & ll|"Disease control rate (DCR) = patients with complete response (CR), partial response (PR) or stable disease (SD) as per RECIST criteria.
Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0 assessed the disease status by imaging (i.e. CT/MRI): CR = disappearance of all tumor lesions; PR = >=30% shrinkage of lesions; SD = Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease (PD); PD = At least a 20% increase in the sum of the longest diameter of all measured target lesions, taking as reference the smallest sum of longest diameter of all target lesions recorded at or after baseline."|18 months|"The full analysis set (FAS) consisted of all patients who received at least one dose of study drug (buparlisib).
CBR analysis was not done for the BM cohort population. DCR analysis was not done for the BM cohort population."||Participants|||Number
819077|NCT01132664|Primary|Overall Response Rate (ORR) - Phase ll|"Objective response rate (ORR) was defined as the rate of patients with best overall response (BOR) equal to complete response (CR) or partial response (PR) according to RECIST 1.0 from the Investigators review.
Per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0 assessed of the disease status by imaging (i.e. CT/MRI): Complete Response (CR) = Disappearance of all tumor lesions; Partial Response (PR)= >=30% shrinkage of lesions; Overall Response (OR) = patients with CR and PR."|18 months|The full analysis set (FAS) consisted of all patients who received at least one dose of study drug (buparlisib)||Participants|||Number
819078|NCT01132664|Primary|Dose Limiting Toxicity (DLT) - Phase l Only|Determination of the maximum tolerated dose (MTD) in the dose escalation part of the study was based upon the estimation of the probability of DLT in Cycle 1 in patients of the dose-determining set.|cycle 1 - 28 days|The Dose–determining set (DDS) for the determination of the MTD consisted of all patients from the safety set in the dose escalation phase who had met the minimum safety evaluation requirements and the minimum exposure criterion or had experienced DLT during Cycle 1 and were discontinued. MTD analysis was done only on the phase lb group.||Participants|||Number
819079|NCT01132690|Secondary|Liver Volume|Liver volume measured by MRI|Baseline and Month 12|||mL||Standard Deviation|Mean
819080|NCT01132690|Secondary|Chemokine (C-C Motif) Ligand 18 (CCL18)|Percent change from baseline in CCL18|Every 3 months for 12 months|||Percent Change from Baseline||Standard Deviation|Mean
819081|NCT01132690|Secondary|Platelet Count|Mean and standard deviation of platelet count per cubic mm|Baseline and 12 months|||platelets per cubic mm||Standard Deviation|Mean
819082|NCT01132690|Secondary|Spleen Volume|Spleen volume measured by MRI|Baseline and Month 12|||mL||Standard Deviation|Mean
819083|NCT01132690|Secondary|Chitotriosidase|Percent change from baseline in chitotriosidase|Every 3 months for 12 months|||Percent Change from Baseline||Standard Deviation|Mean
819084|NCT01132690|Primary|Hemoglobin|median and interquartile range for change from baseline in haemoglobin|Every 3 months for 12 months|||g/dL||Inter-Quartile Range|Median
819085|NCT01132820|Other Pre-specified|VEGFA Expression on Pre-treatment Tumor Specimens|High vs low expression.|Baseline||||||
819086|NCT01132820|Other Pre-specified|Plasma Levels of Endogenous Circulating VEGFA, Levels of Its Endogenous Inhibitor, sFlt-1 (the Truncated, Circulating Portion of VEGFR-1), Circulating TF, and Circulating Par-4||Up to 5 years||||||
819087|NCT01132820|Other Pre-specified|Levels of Receptor Targets Such as VEGFR (1, 2, 3) and PDGFR||Baseline||||||
819088|NCT01132820|Other Pre-specified|Expression of Phosphorylated ERK1 and 2, c-Jun, Stat3, PKC, and p70S6 Kinase||Baseline||||||
819089|NCT01132820|Secondary|Response Without Regard to the Time of Documented Response|Complete and partial tumor response by RECIST 1.1|Tumor responses with time restriction starts at enrollment and goes to 6 months after enrollment or until pt. off study therapy,whichever occurs first. Without time restriction starts at enrollment,lasts until off study therapy, median duration = 2.63 mth|Eligible and Treated Patients||percentage of participants||90% Confidence Interval|Number
819090|NCT01132820|Secondary|Progression Free Survival|Time until disease progression, death, or date of last contact.|Disease that can be assessed by physical exam should be evaluated every cycle. disease assessed by imaging should be evaluated every other cycle. Time frame to determine the date of progression is from the date of enrollment up to 5 years after enrollment|All eligible and evaluable patients||Months||90% Confidence Interval|Median
819091|NCT01132820|Secondary|Overall Survival|The observed length of life from entry into the study to death or the date of last contact.|From study entry to death or last contact, up to 5 years.|Eligible and Treated Patients||months||95% Confidence Interval|Median
819092|NCT01132820|Primary|Progression-free Survival (PFS) = > 6 Months|Number of participants who survived for at least 6 months. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v.1.0) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|For disease evaluated by physical examination, progression was assessed prior to each cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle. Evaluated from time of enrollment until progression or death, up to 5 years|Eligible and Treated Patients||percentage of participants||90% Confidence Interval|Number
819093|NCT01132820|Primary|Tumor Response|Complete and Partial Tumor Response by RECIST 1.1. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall response (OR) = CR + PR.|For diesease evaluated by physical examination, response was assessed prior to each cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle from enrollment until stopping study therapy. The average time on study is 3 mnths|Eligible and Treated Patients||percentage of participants||90% Confidence Interval|Number
819095|NCT01132846|Secondary|Global Visual Analog Scale Area Under the Curve|Range 0 to 7200 Higher is better/improved|Randomization to 72 hours|Based upon data completeness, sample size for this endpoint does not match the overall ROSE population.||units on a scale * hours||Standard Deviation|Mean
819096|NCT01132846|Secondary|Development of Cardio-renal Syndrome||Randomization to 72 hours|Based upon data completeness, sample size for this endpoint does not match the overall ROSE population.||participants|||Number
819097|NCT01132846|Secondary|Change in Blood Urea Nitrogen (BUN)/ Serum Cystatin C Ratio|"BUN measured in mg/dL Cystatin C measured in mg/L
No units were used in calculated the ratio"|Randomization to 72 hours|||ratio||Standard Deviation|Mean
819098|NCT01132846|Secondary|Cumulative Urinary Sodium Excretion||Randomization to 72 hours|||mmol||Standard Deviation|Mean
819099|NCT01132846|Secondary|Change in Treatment Response|"Treatment failure including any of the following:
development of cardio-renal syndrome
worsening/persistent heart failure
significant hypotension requiring discontinuation of study drug
significant tachycardia requiring discontinuation of study drug death"|randomization to 72 hours|Based upon data completeness, sample size for this endpoint does not match the overall ROSE population.||participants|||Number
819100|NCT01132846|Secondary|Change in Heart Failure Status|Persistent or worsening heart failure defined as need for rescue therapy.|randomization to 72 hours|Based upon data completeness, sample size for this endpoint does not match the overall ROSE population.||participants|||Number
819101|NCT01132846|Secondary|Dyspnea Visual Analog Scale Area Under the Curve|Range 0 to 7200 Higher is better|randomization to 72 hours|Based upon data completeness, sample size for this endpoint does not match the overall ROSE population.||units on a scale * hours||Standard Deviation|Mean
819102|NCT01132846|Secondary|Change in Serum Creatinine||randomization to 72 hours|||mg/dL||Standard Deviation|Mean
819103|NCT01132846|Secondary|Change in Clinical Stability- RED-ROSE|Change in clinical stability as assessed by 60 day death, re-hospitalization or unscheduled outpatient visit|Baseline to 60 days|RED-ROSE was a substudy of the main ROSE trial. Only subjects consented and enrolled in RED-ROSE were included in this analysis.||participants|||Number
819104|NCT01132846|Secondary|Worst Reported Symptom Changes-RED-ROSE|"To determine whether changes in worst reported symptom (WRS) (dyspnea, body swelling or fatigue) VAS (WRS-VAS) are related to the response to decongestive therapy as assessed by change in WRS VAS.
WRS range -100 to + 100 Higher number is better (improved)"|Change from Baseline to 72 hours|RED-ROSE was a substudy of the main ROSE study. Only subjects consented and enrolled in RED-ROSE were included in this analysis.||units on a scale||Standard Deviation|Mean
819105|NCT01132846|Secondary|Change in Weight|Change in weight from randomization to 72 hours. Secondary Endpoint|randomization to 72 hours|||lbs||Standard Deviation|Mean
819106|NCT01132846|Primary|Cumulative Urinary Volume|The primary efficacy endpoint is cumulative urinary volume (UV; +/- indwelling urinary catheter) at 72 hours|Randomization to 72 hours|||mL||Standard Deviation|Mean
819107|NCT01132846|Primary|Decongestive Changes- RED-ROSE|"To determine whether changes in pDSS or dyspnea VAS are related to the response to decongestive therapy as evidenced by fluid volume loss
Fluid volume loss is defined as cumulative urinary output minus fluid intake during the first 72 hours post randomization."|Baseline to 72 hours|RED-ROSE is a substudy of the overall ROSE study. Only consented and enrolled RED-ROSE subjects participated.||mL||Standard Deviation|Mean
819108|NCT01132846|Primary|Change in Dyspnea Assessment (RED-ROSE Substudy)|"To determine whether the pDSS is a more sensitive index of variability in dyspnea status than the dyspnea VAS assessed without standardization of conditions at assessment as assessed by change in Dyspnea VAS.
Dyspnea VAS range -100 to + 100 Larger number is better"|Baseline to 72 hours|||units on a scale||Standard Deviation|Mean
819109|NCT01132846|Primary|Change in Cystatin C|The primary Safety endpoint is change in serum cystatin C from randomization to 72 hours.|Randomization to 72 hours|||mg/L||Standard Deviation|Mean
819110|NCT01133171|Secondary|Change in Systolic Blood Pressure||From baseline to six months|||mmHg||Standard Deviation|Mean
819111|NCT01133171|Primary|Change in Percentage of Participants Who Initiate Conversation With Primary Care Provider About Vascular Risk|Only the intervention patients were analyzed for this outcome.|From baseline to six-months|||percentage of patients|||Number
819112|NCT01133275|Secondary|Number of Participants With Grade 3 or 4 Adverse Events Possibly Related to Treatment|Grade 3 or 4 events Related/Possibly Related/Probably Related to study treatment. Number of participants with events specified in the study protocol: Neutropenia, Thrombocytopenia, Febrile Neutropenia, Infection, Sepsis, Venous Thromboembolic Events. Evaluations according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) V4.0.|Up to 54 months|All participants||participants|||Number
819113|NCT01133275|Primary|Number of Participants With Erythroid Response|The rate of erythroid response to treatment with the lenalidomide/prednisone combination in non-del (5q) low and int-1 risk Myelodysplastic Syndrome (MDS) with symptomatic anemia. Hematological improvement erythroid response (HI-E) according to International Working Group (IWG) 2006 criteria.|Up to 7 months|All evaluable participants||participants|||Number
819114|NCT01133288|Secondary|Immune Response to Yulex|A secondary study outcome is the development of an immune response to Yulex using a human IgG anti-Guayule immunoassay. The development of a detectable IgG immune response will be considered a positive study.|3 months|||ug/ml|||Number
819115|NCT01133288|Primary|Sensitization to Yulex|The primary study outcome will be an assessment for sensitization to Yulex as determined by serological assay for Guayule-specific IgE antibodies. The development of a detectable IgE immune response will be considered a positive study.|Approximately 3 months|No participants were exposed to Yulex because the study was terminated.||ng/ml|||Number
819123|NCT01133379|Secondary|Mean Cold Air Stimulus VAS Score at Week 1|Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|1 Week|Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||units on a scale (mm)||Standard Error|Least Squares Mean
819116|NCT01133379|Secondary|Global Subjective VAS Score at Week 6|"At Week 6, participants rated their perception of the pain/discomfort experienced by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. Participants were instructed as follows: Please rate the intensity of the pain/discomfort you have experienced in the last two weeks when drinking cold/hot beverages and/or foods, eating sweet and sour foods, breathing cold air, brushing your teeth or performing any habits/behaviors that solicit your dentinal hypersensitivity pain/discomfort since you first started using the product. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm."|6 Weeks|Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||units on a scale (mm)||Standard Error|Least Squares Mean
819117|NCT01133379|Secondary|Global Subjective VAS Score at Week 4|"At Week 4, participants rated their perception of the pain/discomfort experienced by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. Participants were instructed as follows: Please rate the intensity of the pain/discomfort you have experienced in the last two weeks when drinking cold/hot beverages and/or foods, eating sweet and sour foods, breathing cold air, brushing your teeth or performing any habits/behaviors that solicit your dentinal hypersensitivity pain/discomfort since you first started using the product. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm."|4 Weeks|Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||units on a scale (mm)||Standard Error|Least Squares Mean
819118|NCT01133379|Secondary|Global Subjective VAS Score at Week 2|"At Week 2, participants rated their perception of the pain/discomfort experienced by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. Participants were instructed as follows: Please rate the intensity of the pain/discomfort you have experienced in the last two weeks when drinking cold/hot beverages and/or foods, eating sweet and sour foods, breathing cold air, brushing your teeth or performing any habits/behaviors that solicit your dentinal hypersensitivity pain/discomfort since you first started using the product. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm."|2 Weeks|Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||units on a scale (mm)||Standard Error|Least Squares Mean
819119|NCT01133379|Secondary|Global Subjective VAS Score at Week 1|"At Week 1, participants rated their perception of the pain/discomfort experienced by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. Participants were instructed as follows: Please rate the intensity of the pain/discomfort you have experienced in the last week when drinking cold/hot beverages and/or foods, eating sweet and sour foods, breathing cold air, brushing your teeth or performing any habits/behaviors that solicit your dentinal hypersensitivity pain/discomfort since you first started using the product. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm."|1 Week|Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||units on a scale (mm)||Standard Error|Least Squares Mean
819120|NCT01133379|Secondary|Mean Cold Air Stimulus VAS Score at Week 6|Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|6 Weeks|Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||units on a scale (mm)||Standard Error|Least Squares Mean
819121|NCT01133379|Secondary|Mean Cold Air Stimulus VAS Score at Week 4|Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|4 Weeks|Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||units on a scale (mm)||Standard Error|Least Squares Mean
819122|NCT01133379|Secondary|Mean Cold Air Stimulus VAS Score at Week 2|Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|2 Weeks|Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||units on a scale (mm)||Standard Error|Least Squares Mean
819135|NCT01133392|Secondary|Pharmacokinetic Parameter: Maximum Serum Insulin Concentration [Cmax]|The maximum observed insulin lispro concentration following dosing.|0 to 8 hours post dose|All participants who had at least one study treatment and had evaluable PK data.||picomole/liter (pmol/L)||Geometric Coefficient of Variation|Geometric Mean
829104|NCT01216397|Secondary|Linagliptin: Time to Maximum Measured Concentration of the Analyte in Plasma (Tmax)|Median of the t_max of linagliptin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set||hr||Full Range|Median
819124|NCT01133379|Secondary|Mean Tactile Sensitivity VAS Score at Week 6|Tooth sensitivity was measured using a Visual Analogue Scale (VAS). At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|6 Weeks|Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||units on a scale (mm)||Standard Error|Least Squares Mean
819125|NCT01133379|Secondary|Mean Tactile Sensitivity VAS Score at Week 4|Tooth sensitivity was measured using a Visual Analogue Scale (VAS). At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|4 Weeks|Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||units on a scale (mm)||Standard Error|Least Squares Mean
819126|NCT01133379|Secondary|Mean Tactile Sensitivity VAS Score at Week 2|Tooth sensitivity was measured using a Visual Analogue Scale (VAS). At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|2 Weeks|Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||units on a scale (mm)||Standard Error|Least Squares Mean
819127|NCT01133379|Secondary|Mean Tactile Sensitivity VAS Score at Week 1|Tooth sensitivity was measured using a Visual Analogue Scale (VAS). At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|1 Week|Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||units on a scale (mm)||Standard Error|Least Squares Mean
819128|NCT01133379|Primary|Mean Tactile Sensitivity Score at Week 1|Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant, at each visit.|1 Week|Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||grams||Standard Error|Least Squares Mean
819129|NCT01133379|Primary|Mean Tactile Sensitivity Score at Week 2|Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant, at each visit.|2 Weeks|Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||grams||Standard Error|Least Squares Mean
819130|NCT01133379|Primary|Mean Tactile Sensitivity Score at Week 4|Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant, at each visit.|4 Weeks|Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||grams||Standard Error|Least Squares Mean
819131|NCT01133379|Primary|Mean Tactile Sensitivity Score at Week 6|Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant, at each visit.|6 Weeks|Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||grams||Standard Error|Least Squares Mean
819132|NCT01133392|Secondary|Pharmacodynamic Parameter: Total Amount of Glucose Infused (Gtot)|The total amount of glucose infused during the euglycemic clamp procedure.|0 to 8 hours post dose|All participants who had at least one study treatment and had evaluable PD data.||grams (g)||Geometric Coefficient of Variation|Geometric Mean
819133|NCT01133392|Secondary|Pharmacodynamic Parameter: Time of Maximum Glucose Infusion Rate (tRmax)|Time of maximal glucose infusion rate.|0 to 8 hours post dose|All participants who had at least one study treatment and had evaluable PD data.||hours||Geometric Coefficient of Variation|Geometric Mean
819134|NCT01133392|Secondary|Pharmacodynamic Parameter: Maximum Glucose Infusion Rate (Rmax)|The maximum observed glucose infusion rate during the euglycemic clamp procedure.|0 to 8 hours post dose|All participants who had at least one study treatment and had evaluable pharmacodynamic (PD) data.||milligrams per minute (mg/min)||Geometric Coefficient of Variation|Geometric Mean
819136|NCT01133392|Primary|Pharmacokinetic Parameter: Area Under the Serum Insulin Concentration Versus Time Curve From Time Zero to the Last Time Point With a Measurable Concentration [AUC0-tlast]|Primary outcome measure is based on the pharmacokinetic area under the concentration-time curve from time 0 to the last time point with a measurable concentration.|0 up to 8 hours post dose|All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data.||picomole*hour/liter (pmol*h/L)||Geometric Coefficient of Variation|Geometric Mean
819137|NCT01133418|Secondary|Academic Improvement Measurement System - Web-based (AIMSWEB) Reading Score (Proportion Accurate)|Number of words read correctly divided by number of words read (range = 0-1.0) Higher values represent better reading accuracy|2 months|||units on a scale||Standard Deviation|Mean
819138|NCT01133418|Secondary|Intra-individual Variability on Go/No-Go Task|Standard deviation of reaction times for correct responses to Go trials on a Go/No-Go Task|2 months|||milliseconds||Standard Deviation|Mean
819139|NCT01133418|Primary|Clinical Global Impression - Improvement|Blinded ratings of clinical global impression - Improvement. Scale = 1 (Very Much Improved) - 7 (Very Much Worse) Lower scores represent more improvement.|2 months|One child in the Cognitive Training Group and one child in the Non-progressive Cognitive Training group were missing CGI data.||units on a scale||Standard Deviation|Mean
819140|NCT01133418|Primary|Total ADHD Symptom Score From Vanderbilt ADHD Parent Rating Scale|"Total ADHD Symptom Score on the Parent Vanderbilt Rating Scales; range = 0-54; this score is computed by summing the 18 ADHD symptom items which are each rated on a 0-3 Likert scale (0=Never; 1=Occasionally; 2=Often; 3=Very often); higher scores indicate higher severity of ADHD symptoms."|2 months|||units on a scale||Standard Deviation|Mean
819141|NCT01133522|Secondary|Percent Change From Baseline to End of the Dosing Interval in PCSK9|Serum PCSK9 concentrations were determined by using a qualified enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 15 ng/mL.|Baseline and Day 43 for QW and Q2W groups or Day 57 for Q4W group|Participants with non-missing data||percent change||Standard Deviation|Mean
819142|NCT01133522|Secondary|Percent Change From Baseline to End of the Dosing Interval in LDL-C||Baseline and Day 43 for QW and Q2W groups or Day 57 for Q4W group|Participants with non-missing data||percent change||Standard Deviation|Mean
819143|NCT01133522|Secondary|Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Evolocumab|Area under the unbound evolocumab serum concentration-time curve from time of last dose to time of last quantifiable concentration following the last dose of evolocumab.|Day 29 predose (last dose for Cohorts 3-7) and Days 36 (predose for Cohorts 1 and 2), 40, 43, 50, 57, 64, 71, 78, and 85|Pharmacokinetic analysis set with available data||day*μg/mL||Standard Deviation|Mean
819144|NCT01133522|Primary|Number of Participants With Anti-Evolocumab Antibodies|Serum samples were analyzed by an electrochemiluminescence (ECL)-based immunoassay for anti-evolocumab binding antibodies. Positive samples were subsequently tested in a receptor-ligand binding bioassay for anti-evolocumab neutralizing antibodies|From the first dose of study drug until Day 85|Safety analysis set||participants|||Number
819145|NCT01133522|Secondary|Maximum Observed Plasma Concentration (Cmax) of Evolocumab|Serum concentrations of evolocumab were measured by a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 800 ng/mL.|Day 1, predose and Days 4, 8, 15, 22, 29, 36, 40, 43, 50, 57, 64, 71, 78, and 85|The Pharmacokinetic analysis set consisted of all participants for whom at least 1 pharmacokinetic parameter or endpoint could be adequately estimated. Serum evolocumab concentrations were not detectable in Cohorts 1 and 2.||μg/mL||Standard Deviation|Mean
819146|NCT01133522|Primary|Number of Participants With Adverse Events|"The relationship of each adverse event to the investigational product was assessed by the investigator.
A serious adverse event (SAE) is defined as an adverse event that
is fatal
is life threatening (places the subject at immediate risk of death)
requires in-patient hospitalization or prolongation of existing hospitalization
results in persistent or significant disability/incapacity
is a congenital anomaly/birth defect
other significant medical hazard."|From the first dose of study drug until Day 85|Safety analysis set||participants|||Number
819147|NCT01133626|Primary|The 24-hour Serum Cortisol Weighted Mean After 42 Days of Treatment|"Geometric mean serum cortisol weighted mean values were calculated at baseline and after 6 weeks (42 days) of treatment. The geometric mean ratio of week 6 / baseline is reported. The primary outcome compares the BDP HFA and Placebo treatment arms. The comparison of active control (Placebo/Prednisone) and Placebo treatment arms is an other pre-specified outcome."|Day 0 (Baseline), Day 42|Per protocol population||ratio||Standard Error|Geometric Mean
819148|NCT01133665|Secondary|Number of Participants With Lymphocyte Count Increased Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|Analysis Population Description: The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
819149|NCT01133665|Secondary|Number of Participants With Febrile Neutropenia Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|Analysis Population Description: The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
819150|NCT01133665|Secondary|Number of Participants With C. Diff Infection Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|Analysis Population Description: The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
819151|NCT01133665|Secondary|Number of Participants With Infusion Related Reaction Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|Analysis Population Description: The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
819152|NCT01133665|Secondary|Number of Participants With Blood Bilirubin Increased Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|Analysis Population Description: The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
819629|NCT01129557|Secondary|Pre- and Post-treatment 24-urine Aldosterone in Subjects With and Without Aldosterone Breakthrough.|Compares baseline and final (9 month) 24-hour urine aldosterone for subjects with and without aldosterone breakthrough|Baseline and Final (9 month)|||(ug/day)||Standard Deviation|Mean
819153|NCT01133665|Secondary|Number of Participants With Weight Loss Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|Analysis Population Description: The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
819154|NCT01133665|Secondary|Number of Participants With Dyspnea Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|Analysis Population Description: The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
819155|NCT01133665|Secondary|Number of Participants With Back Pain Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|Analysis Population Description: The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
819156|NCT01133665|Secondary|Number of Participants With Alanine Aminotransferase Increased Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|Analysis Population Description: The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
819157|NCT01133665|Secondary|Number of Participants With Peripheral Sensory Neuropathy Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|Analysis Population Description: The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
819158|NCT01133665|Secondary|Number of Participants With Neck Pain Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
819159|NCT01133665|Secondary|Number of Participants With Hypocalcaemia Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
819160|NCT01133665|Secondary|Number of Participants With Fever Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
819161|NCT01133665|Secondary|Number of Participants With Xerostomia Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 3|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
819162|NCT01133665|Secondary|Number of Participants With Aspartate Aminotransferase Increased Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
819163|NCT01133665|Secondary|Number of Participants With Alkaline Phosphatase Increased Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
819164|NCT01133665|Secondary|Number of Participants With Hyperglycemia Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
819165|NCT01133665|Secondary|Number of Participants With Acneiform Rash Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
819166|NCT01133665|Secondary|Number of Participants With Thrombocytopenia Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
819167|NCT01133665|Secondary|Number of Participants With Hypophosphatemia Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
819168|NCT01133665|Secondary|Number of Participants With Hypokalemia Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
819169|NCT01133665|Secondary|Number of Participants With Headache Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
819170|NCT01133665|Secondary|Number of Participants With Neutropenia Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
819171|NCT01133665|Secondary|Number of Participants With Hyponatremia Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
819172|NCT01133665|Secondary|Number of Participants With Diarrhea Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
819698|NCT01130597|Secondary|Change in Urine Albumin to Creatinine Ratio (ACR) From Baseline to Week 4 Among Participants With ACR ≥ 30 mg/g at Baseline||Baseline and Day 28|Participants with urine ACR ≥ 30 mg/g at baseline and available data at Week 4||mg/g||Standard Error|Mean
819173|NCT01133665|Secondary|Number of Participants With White Blood Cell Decreased Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
819174|NCT01133665|Secondary|Number of Participants With Vomiting Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
819175|NCT01133665|Secondary|Number of Participants With Pain Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
819176|NCT01133665|Secondary|Number of Participants With Oral Mucositis Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
819177|NCT01133665|Secondary|Number of Participants With Lymphopenia Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
819178|NCT01133665|Secondary|Number of Participants With Hypoalbuminemia Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
819179|NCT01133665|Secondary|Number of Participants With Nausea Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
819180|NCT01133665|Secondary|Number of Participants With Anorexia Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
819181|NCT01133665|Secondary|Number of Participants With Anemia Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
819182|NCT01133665|Secondary|Number of Participants With Constipation Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
819183|NCT01133665|Secondary|Number of Participants With Maculopapular Rash Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
819184|NCT01133665|Secondary|Number of Participants With Fatigue Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
819185|NCT01133665|Primary|Correlate the Presence of Specific Fc RIIIa Polymorphisms With Progression-free Survival in Subjects Receiving Cetuximab and Lenalidomide for SCCHN.|Progression-free survival (PFS) was defined as time from date of the first treatment dose administered to the earlier of disease progression or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|24 months|||months||Full Range|Median
819186|NCT01133704|Secondary|Overall Survival|Subjects were followed for 3 years from the time of randomization or until death.|Time from randomization until 36 months|All randomized participants||Months||95% Confidence Interval|Median
819187|NCT01133704|Primary|Overall Time to Disease Progression|Overall time to disease progression in subjects with asymptomatic metastatic hormone-refractory prostate cancer treated with sipuleucel-T (APC8015) compared to overall time to disease progression in subjects treated with placebo.|from randomization to 36 months|||Weeks||95% Confidence Interval|Median
819188|NCT01133756|Secondary|Biomarker-based Proportion of Biomarker-Progression-Free Survival (B-PFS) at Week 12, Within Treatment Group|Due to the limited enrollment despite significant diligence to boost enrollment and the complex study design required to manage hematologic toxicity, the study was terminated before the initiation of Phase 2. Hence the analysis was not conducted.|Week 12|Due to the limited enrollment despite significant diligence to boost enrollment and the complex study design required to manage hematologic toxicity, the study was terminated before the initiation of Phase 2. Hence the analysis was not conducted.|||||
819189|NCT01133756|Secondary|Biomarker CA125-based Overall Response Rate (B-ORR), Within Treatment Group|Due to the limited enrollment despite significant diligence to boost enrollment and the complex study design required to manage hematologic toxicity, the study was terminated before the initiation of Phase 2. Hence the analysis was not conducted.|Day 1 of every cycle, at end of treatment visit and every 2 months during follow-up period for patients who complete study without progressive disease.|Due to the limited enrollment despite significant diligence to boost enrollment and the complex study design required to manage hematologic toxicity, the study was terminated before the initiation of Phase 2. Hence the analysis was not conducted.|||||
819251|NCT01126268|Secondary|Wound Size at Follow up|Wound size area was determined by measuring the greatest length of the wound in two perpendicular dimensions with a standard metric ruler. The two measurements were multiplied together to provide an estimate of the overall wound size. Surrounding erythema was not included in the measurement.|6 to 8 days after treatment|All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing||cm^2||Standard Deviation|Mean
819699|NCT01130597|Secondary|Percentage of Patients Whose Spironolactone Dose Was Increased Up to 50 mg/Day||56 Days|||percentage of participants|||Number
819190|NCT01133756|Primary|Number of Participants With Dose Limiting Toxicity (DLT)|DLTs were defined as clinically significant adverse events occurring less than or equal to 21 days after commencing study treatment and considered to be possibly or probably related to study treatment by the Investigator. If 1 DLT occurred at any dose level, the cohort was to be expanded to include a maximum of six evaluable subjects. If 2 DLTs occurred at any dose level, the maximum tolerated dose (MTD) was to be either defined as the preceding dose, or an intermediate dose. To evaluate an intermediate dose, an additional dose cohort could be added to more accurately define the MTD.|Cycle 1 (21 days)|Safety analysis was evaluated based on Safety Population, defined as all subjects enrolled into the Phase 1b portion of this study, except for those who (i) dropped out of the study prior to receiving any study drug, or (ii) were without any safety assessments following the first dose of study drug.||Participants|||Number
819191|NCT01133821|Secondary|Psychosocial Functioning|We hypothesize that subjects assigned to IPSR-QUE will experience greater improvements in psychosocial functioning over time compared to those assigned to IPSRT-PLA. The main outcomes will be the changes in Q-LES-Q, IIP, and LIFE-RIFT over 52 weeks|up to 52 weeks||||||
819192|NCT01133821|Primary|Depression Severity|"The primary endpoint is depression severity at week 20, which will be measured via the Hamilton Rating Scale for Depression 17-item score (HRSD-17) and the Young Mania Rating Scale (YMRS).
Remission is defined as 3 consecutive weeks with HRSD-17≤8 and YMRS≤8"|20 weeks|Intent to treat; patients were assessed weekly||Participants|||Count of Participants
819193|NCT01133847|Secondary|Test of Silent Reading Fluency and Comprehension (TOSREC)|The TOSREC measures sentence-level comprehension and silent reading fluency. It is a sentence verification task; children are presented with a list of sentences and must tell whether they are true or false. Items are based on common knowledge (e.g., All apples are blue). The raw score is the number of items answered correctly in 3 minutes. Standardized with a mean of 100 and standard deviation of 15 are reported here. Higher scores represent a better outcome.|Week 16, End of Active Treatment Phase|Six excluded from analyses (1 from ADHD Treatment , 1 from Intensive Reading Instruction , 4 from Combined ) because upon ex post-facto review of records, they did not meet inclusion criteria and had been included in error. Other reductions in numbers analyzed on this variable were due to missing data.||standardized scores||Standard Error|Least Squares Mean
819194|NCT01133847|Secondary|Test of Word Reading Efficiency (TOWRE) - Phonemic Decoding Efficiency|The TOWRE Phonemic Decoding Efficiency measures the student’s fluent decoding of nonsense words that follow the spelling rules of the English language. The raw score is the number of nonwords identified correctly in 45 seconds. Standardized scores with a mean of 100 and standard deviaion of 15 are reported here. Higher scores represent a better outcome.|Week 16 (End of Active Treatment Phase) and Follow-Up|Six excluded from analyses (1 from ADHD Treatment , 1 from Intensive Reading Instruction , 4 from Combined ) because upon ex post-facto review of records, they did not meet inclusion criteria and had been included in error. Other reductions in numbers analyzed on this variable were due to missing data.||standardized scores||Standard Error|Least Squares Mean
819195|NCT01133847|Secondary|Test of Word Reading Efficiency (TOWRE) - Sight Word Efficiency|The TOWRE Sight Word Efficiency subtest measures fluency of reading words in lists. The raw score is the number of words or nonwords identified correctly in 45 seconds. Standard scores with a mean of 100 and standard deviaion of 15 are reported here. Higher scores represent a better outcome.|Week 16 (End of Active Treatment Phase) and Follow-Up|Six excluded from analyses (1 from ADHD Treatment , 1 from Intensive Reading Instruction , 4 from Combined ) because upon ex post-facto review of records, they did not meet inclusion criteria and had been included in error. Other reductions in numbers analyzed on this variable were due to missing data.||standardized scores||Standard Error|Least Squares Mean
819196|NCT01133847|Secondary|Dynamic Indicators of Basic Early Literacy Skills Oral Reading Fluency Subtest (DIBELS ORF)|DIBELS ORF measures oral reading fluency in connected text. Students are presented with a passage on their grade level to read orally, and the score is the number of words of the passage read correctly in a one-minute period. Students in this study read two passages at each test administration, and the mean score for the two passages was the dependent variable analyzed. A research synthesis of studies reporting psychometric properties for DIBELS ORF determined that reliability coefficients in these studies exceeded .80 and that the measure demonstrated moderate to high concurrent and predictive validity across studies (Goffreda & DiPerna, 2010).|Week 16 (End of Active Treatment Phase) and Follow-Up|Six excluded from analyses (1 from ADHD Treatment , 1 from Intensive Reading Instruction , 4 from Combined ) because upon ex post-facto review of records, they did not meet inclusion criteria and had been included in error. Other reductions in numbers analyzed on this variable were due to missing data.||words read correctly per minute||Standard Deviation|Mean
819197|NCT01133847|Secondary|Wechsler Individual Achievement Test-III (WIAT-III) Reading Comprehension Subtest|The WIAT-III is an individually-administered test of academic achievement. This subtest involves reading sentences and longer passages and then answering a set of literal and inferential comprehension questions about the text. Scores reported here are standardized scores with a mean of 100 and standard deviation of 15. Higher scores represent a better outcome.|Week 16, End of Active Treatment Phase|Six excluded from analyses (1 from ADHD Treatment , 1 from Intensive Reading Instruction , 4 from Combined ) because upon ex post-facto review of records, they did not meet inclusion criteria and had been included in error.||standardized scores||Standard Error|Least Squares Mean
819198|NCT01133847|Primary|Wechsler Individual Achievement Test-III (WIAT-III) Pseudoword Decoding Subtest|The WIAT-III is an individually-administered test of academic achievement. In the Pseudoword Decoding subtest students read a list of increasingly difficult nonsense words as a test of their ability to use phonics to decode unknown words. Scores reported here are standardized scores with a mean of 100 and standard deviation of 15. Higher scores represent a better outcome.|Week 16 (End of Active Treatment Phase) and Follow-Up|Six excluded from analyses (1 from ADHD Treatment , 1 from Intensive Reading Instruction , 4 from Combined ) because upon ex post-facto review of records, they did not meet inclusion criteria and had been included in error. Other reductions in numbers analyzed on this variable were due to missing data.||standardized scores||Standard Error|Least Squares Mean
819252|NCT01126268|Secondary|Wound Size at Baseline|Wound size area was determined by measuring the greatest length of the wound in two perpendicular dimensions with a standard metric ruler. The two measurements were multiplied together to provide an estimate of the overall wound size. Surrounding erythema was not included in the measurement.|baseline|All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing||cm^2||Standard Deviation|Mean
819199|NCT01133847|Primary|Wechsler Individual Achievement Test-III (WIAT-III) Word Reading Subtest|The WIAT-III is an individually-administered test of academic achievement. In the Word Reading subtest students read a list of increasingly difficult words. Scores reported here are standardized scores with a mean of 100 and standard deviation of 15.|Week 16 (End of Active Treatment Phase) and Follow-Up|Six excluded from analyses (1 from ADHD Treatment , 1 from Intensive Reading Instruction , 4 from Combined ) because upon ex post-facto review of records, they did not meet inclusion criteria and had been included in error. Other discrepancies in numbers are due to missing data.||standardized scores, M=100, SD = 15||Standard Error|Least Squares Mean
819200|NCT01133847|Primary|Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Teacher Rating of Hyperactivity-impulsivity|Rating Scale of ADHD symptomology completed by parents and teachers. Raters evaluate how well each DSM-IV ADHD symptom describes a child on a four-point Likert scale (0=Not at all, 1=Just a little, 2=Quite a bit, 3=Very much). The measure shows adequate internal consistency (.94) and test-retest reliability (Bussing et al., 2008; Gau et al., 2008).|Week 16 (End of Active Treatment Phase) and Follow-Up|Six excluded from analyses (1 from ADHD Treatment , 1 from Intensive Reading Instruction , 4 from Combined) because upon ex post-facto review of records, they did not meet inclusion criteria and had been included in error. Other reductions in numbers analyzed on this variable were due to missing data.||Units on a scale||Standard Error|Least Squares Mean
819201|NCT01133847|Primary|Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Teacher Rating of Inattention|Rating Scale of ADHD symptomology completed by parents and teachers. Raters evaluate how well each DSM-IV ADHD symptom describes a child on a four-point Likert scale (0=Not at all, 1=Just a little, 2=Quite a bit, 3=Very much). The measure shows adequate internal consistency (.94) and test-retest reliability (Bussing et al., 2008; Gau et al., 2008).|Week 16 (End of Active Treatment Phase) and Follow-Up|Six excluded from analyses (1 from ADHD Treatment , 1 from Intensive Reading Instruction , 4 from Combined ) because upon ex post-facto review of records, they did not meet inclusion criteria and had been included in error. Other reductions in numbers analyzed on this variable were due to missing data.||Units on a scale||Standard Error|Least Squares Mean
819202|NCT01133847|Primary|Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Parent Rating of Hyperactivity-impulsivity|Rating Scale of ADHD symptomology completed by parents and teachers. Raters evaluate how well each DSM-IV (Diagnostic and Statistical Manual) ADHD symptom describes a child on a four-point Likert scale (0=Not at all, 1=Just a little, 2=Quite a bit, 3=Very much). The measure shows adequate internal consistency (.94) and test-retest reliability (Bussing et al., 2008; Gau et al., 2008).|16 weeks (end of Active Treatment phase), and follow-up|Six excluded from analyses (1 from ADHD Treatment , 1 from Intensive Reading Instruction , 4 from Combined ) because upon ex post-facto review of records, they did not meet inclusion criteria and had been included in error. Other reductions in numbers analyzed on this variable were due to missing data.||units on a scale||Standard Error|Least Squares Mean
819203|NCT01133847|Primary|Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Parent Rating of Inattention|Rating Scale of ADHD symptomology completed by parents and teachers. Raters evaluate how well each DSM-IV (Diagnostic and Statistical Manual) ADHD symptom describes a child on a four-point Likert scale (0=Not at all, 1=Just a little, 2=Quite a bit, 3=Very much). The measure shows adequate internal consistency (.94) and test-retest reliability (Bussing et al., 2008; Gau et al., 2008).|16 weeks (end of Active Treatment phase), and follow-up|Six excluded from analyses (1 from ADHD Treatment , 1 from Intensive Reading Instruction , 4 from Combined ) because upon ex post-facto review of records, they did not meet inclusion criteria and had been included in error. Other reductions in numbers analyzed on this variable were due to missing data.||Units on a scale||Standard Error|Least Squares Mean
819204|NCT01133860|Secondary|in Vitro Function of Platelets Produced During Therapy in Responding Patients|in vitro platelet function will be assessed in patients achieving a platelet count of 100 x10e9/L or more at the end of the therapy|21 days or 42 days of therapy|||participants|||Number
819205|NCT01133860|Secondary|All Types of Adverse Events|All type of adverse events were registered.Results indicate the number of participants who experience a side effect of the drug.|21 days and/or 42 days of therapy, 15 and 30 days after the end of therapy|||number of participants|||Number
819206|NCT01133860|Secondary|Bleeding Tendency Assessed by WHO Bleeding Score|The percentage of patients with bleeding diathesis (grade 1, i.e. cutaneous bleeding, or grade 2, i.e. mild blood loss, according to WHO bleeding score) was calculated at baseline and at the end of therapy. The results are expressed as the mean change in the percentage of patients with bleeding diathesis (95%CI).|21 days and/or 42 days of therapy, 15 and 30 days after the end of therapy|||participants||95% Confidence Interval|Mean
819207|NCT01133860|Primary|Response to Drug Based on Platelet Count at the End of Therapy|The primary endpoints were the achievement of a platelet count over 100 x10e9/L or at least 3 times the baseline value (major response), or at least twice the baseline value but less than major response (minor response). The overall response to therapy is reported. Platelet count was measured at the end of therapy (21 or 42 days, see study design) by phase-contrast microscopy.|21 days and/or 42 days of therapy, 15 and 30 days after the end of therapy|||percentage of participants||95% Confidence Interval|Number
819208|NCT01133977|Other Pre-specified|Overall Response Rate (ORR) (for Phase 2)|ORR, defined as percentage of participants with best confirmed response (complete response [CR] or partial response [PR]). A confirmatory scan was required after no less than 4 weeks and no later than 8 weeks, starting on the date that the response was first recorded.|From the date of randomization until disease progression or death or up to approximately 2 years||||||
819209|NCT01133977|Other Pre-specified|Overall Survival (OS) (for Phase 2)|OS, defined as the time from the date of randomization until the date of death. Few events of deaths (9 events in the Lenvatinib + Dacarbazine arm and 4 events in the Dacarbazine arm) were reported to calculate the median OS or to draw conclusions regarding the OS.|From the date of randomization until death or up to approximately 2 years||||||
819210|NCT01133977|Other Pre-specified|Time to Progression (TTP) (for Phase 2)|TTP, defined as the time from the date of randomization until the date of progressive disease.|From the date of randomization until disease progression or death or up to approximately 2 years||||||
819253|NCT01126268|Secondary|Pain (Sign and Symptom of Infection) at Follow up|Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.|6 to 8 days after treatment|All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing||participants|||Number
819211|NCT01133977|Secondary|Progression Free Survival (PFS) (for Phase 2)|PFS was defined as the time from the date of randomization of a participant until (1) the date of first documented progression of such participant's disease based on Investigator assessments according to Response Evaluation Criteria In Solid Tumors (RECIST v. 1.1) or (2) the date of such participant's death due to any cause. Progression was defined as at least a 20% increase or 5 mm increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions, based on Investigator assessment according to RECIST 1.1. If missing assessments, imputed dates were used in the analysis.|From the date of randomization until the date of disease progression or death (whichever was earlier) or up to approximately 2 years|All randomized participants who received at least one dose of study drug without major protocol eligibility violations were included in the Modified Intent-to-Treat (MITT) Analysis Set.||Weeks||95% Confidence Interval|Median
819212|NCT01133977|Primary|Number of Participants With Adverse Events/Serious Adverse Events (AEs/SAEs)|Safety assessments consisted of monitoring and recording all AEs, including all Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v. 4.0) grades, and SAEs; regular monitoring of hematology, blood chemistry, and urine values; periodic measurement of vital signs and electrocardiograms (ECGs); and performance of physical examinations. Details of AEs and SAEs are provided in the reported adverse event section.|From signing of informed consent up to 30 days after the last dose, up to approximately 2 years|Safety Analysis Set: All participants enrolled in the Phase 1b and Phase 2 portion of this study, except for those who (i) dropped out of the study prior to receiving any study drug, or (ii) were without any safety assessment following the first dose of study drug.||Participants|||Number
819213|NCT01133977|Primary|Dose Limiting Toxicity (DLT) of Lenvatinib Administered in Combination With Dacarbazine (for Phase 1b)|DLTs were defined as clinically significant adverse events (AEs) occurring less than or equal to 21 days after commencing study treatment and considered by the Investigator to be possibly or probably related to study treatment.|From Day 1 through 21 days (one cycle)|Safety Analysis Set: All participants enrolled in the Phase 1b portion of this study, except for those who (i) dropped out of the study prior to receiving any study drug, or (ii) were without any safety assessment following the first dose of study drug.||Participants with DLT|||Number
819214|NCT01134016|Secondary|Safety Blood and Urine Test|"Hematology laboratory data
Biochemistry laboratory data
Urinalysis
AE; AE not including the natural progress of the underlying disease
Incidence of toxicity ≥ grade 3 according to NCI CTCAE version 4.03
Physical examination
Vital signs changes
Electrocardiogram examination results (including HR, QRS, QT, QTc, RR intervals)"|pre-screenting and every 14-day period||||||
819215|NCT01134016|Secondary|Number of Participants in the PP Population With Better Than SD at Target Lesion, Better Than Non-CR/Non-PD at Non-target Lesion and no New Lesion|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for overall response by CT: Judgement by total siutation of target, non-target and new lesions.
Meaning of Target lesion: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), Sum down 30% or more from target lesion baseline; Progressive Disease(PD), Sum up at least 20% from smallest value (nadir) and Absolute increase ≥ 5 mm; Stable Disease (SD), Neither enough shrinkage for PR nor enough growth for PD.
non-target lesion: CR: All non-target lesions disappeared and All lymph nodes <10 mm; Non-CR/Non-PD: Non-target lesion(s) still present and Lymph nodes ≥10 mm; PD: Unequivocal progression; New lesion :Unequivocal new cancer lesions Overall SD response should be better than SD at target lesion, better than Non-CR/Non-PD t non-target lesion and no new lesion."|pre-screening and end of treatment|Per-protocol (PP) Population: All patients who completed at least 3 cycles of treatment with proper imaging assessment (RECIST).||participants|||Number
819216|NCT01134016|Secondary|AUC0-t on Day 28|Pharmacokinetic samples will be obtained from all the patients in each dose cohort treated in all phases of the study. Patients will only be sampled during their first treatment cycle only.|30 minutes prior to and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 14, and 24 hours after dose of Day 28|||log(mg*hr/mL)||95% Confidence Interval|Mean
819217|NCT01134016|Secondary|AUC0-t on Day 1|Pharmacokinetic samples will be obtained from all the patients in each dose cohort treated in all phases of the study. Patients will only be sampled during their first treatment cycle only.|within 30 minutes prior to and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 14, and 24 hours after dose of Day 1|||log(mg*hr/mL)||95% Confidence Interval|Mean
819218|NCT01134016|Secondary|Maximum Plasma Concentration After Dosing on Day 28|Pharmacokinetic samples will be obtained from all the patients in each dose cohort treated in all phases of the study. Patients will only be sampled during their first treatment cycle only.|30 minutes prior to and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 14, and 24 hours after dose of Day 28|||log(mg/ml)||95% Confidence Interval|Mean
819219|NCT01134016|Secondary|Maximum Plasma Concentration After on Day 1|Pharmacokinetic samples will be obtained from all the patients in each dose cohort treated in all phases of the study. Patients will only be sampled during their first treatment cycle only.|30 minutes prior to and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 14, and 24 hours after dose of Day 1|Pharmacokinetic (PK) Population: All patients who received at least 1 dose of antroquinonol with sufficient post-dose bio-samples collected for PK profile characterization.||Log(mg/ml)||95% Confidence Interval|Mean
819220|NCT01134016|Secondary|Half-life Time From Overall Study|Pharmacokinetic samples will be obtained from all the patients in each dose cohort treated in all phases of the study. Patients will only be sampled during their first treatment cycle only. Individual serum concentration versus (vs) time curves were plotted in 1 graph by dose level on both linear/linear and log10/linear scales. Mean serum concentration vs time curves were also presented in 1 graph for dose levels on both linear/linear and log10/linear scales.|30 minutes prior to and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 14, and 24 hours after dose of Day 1&28|||hours||Standard Deviation|Mean
819221|NCT01134016|Secondary|Tmax After Dose|Pharmacokinetic samples will be obtained from all the patients in each dose cohort treated in all phases of the study. Patients will only be sampled during their first treatment cycle only. Individual serum concentration versus (vs) time curves were plotted in 1 graph by dose level on both linear/linear and log10/linear scales. Mean serum concentration vs time curves were also presented in 1 graph for dose levels on both linear/linear and log10/linear scales.|30 minutes prior to and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 14, and 24 hours after dose of Day 1&28|||hours||Full Range|Median
819254|NCT01126268|Secondary|Pain (Sign and Symptom of Infection) at Baseline|Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.|baseline|All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing||participants|||Number
819222|NCT01134016|Primary|To Determind the Maximum Tolerable Dose for Antroquinonol|"The study design consisted of 2 phases, the accelerated titration phase and the standard titration phase.
During the accelerated titration phase, patients were enrolled in a cohort of 1 new patient for each dose level and treated for 4 weeks at that level. Any DLT or instance of MT during any 4 week treatment at any dose level led to the initiation of standard titration (3+3) phase.
If none of the first 3 patients experienced any DLT, then dose escalation proceeded for the next cohort of patients. If 1 of 3 patients developed DLT, the cohort was expanded to at most 6 patients (another 3 patients added subsequently). If exactly 1 of the 6 patients experienced DLT, then escalation to the next dose level occurred. If more than 1 patient developed DLT in any dose cohort, the dose escalation was withheld and the prior dose level was considered as the MTD unless the present dose level was level 1"|DLT is to be observed during 4 week period|Intent-to-Treat (ITT) Population: All patients who received at least 1 dose of antroquinonol.||mg|||Number
819223|NCT01134042|Other Pre-specified|Number of the Indicated Unscheduled Asthma-related Healthcare Visits During the Treatment Period|All unscheduled asthma-related visits to a physician’s office, visits to urgent care, visits to the emergency department, and hospitalizations (ICU=intensive care unit; GW=general ward) associated with severe asthma exacerbations or other asthma-related healthcare issues were recorded.|From Baseline up to Week 24/Withdrawal Visit|ITT Population||Number of visits||Standard Deviation|Mean
819224|NCT01134042|Other Pre-specified|Number of Participants With the Indicated Global Assessment of Change Questionnaire Responses at Weeks 4, 12, and 24|At the end of Week 4, Week 8, and Week 24/Early Withdrawal, the Global Assessment of Change Questionnaire that assesses changes in asthma symptoms (AS) and rescue medication use (RMU) was completed by the participants. The number of participants who chose the following answers to the questionnaire were determined: much better, somewhat better, a little better, the same, a little worse, somewhat worse, much worse (to assess the changes in asthma symptoms); much less often, somewhat less often, a little less often, the same, a little more often, somewhat more often, much more often (to assess the changes in the frequency of rescue medication use).|Week 4, Week 12, and Week 24/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||participants|||Number
819225|NCT01134042|Other Pre-specified|Change From Baseline in the Asthma Control Test (ACT) Scores at Week 12 and Week 24|"The ACT is a 5-item questionnaire developed as a measure of the participant's asthma control. Questions are designed to be self-completed by the participant and include the following: In the past 4 weeks, How much of the time did your asthma keep you from getting as much done at work, school or at home?, How often have you had shortness of breath?, How often did your asthma symptoms wake you up at night or earlier than usual in the morning?, How often have you used your rescue inhaler or nebulizer medication (such as albuterol)? and How would you rate your asthma control? The ACT total score is defined as the sum of the scores from all 5 questions, provided all questions have been answered; thus, the total score ranges from 5 (poor control of asthma) to 25 (complete control of asthma). A score of 20 or higher indicates well-controlled asthma. Change from Baseline was calculated as the total score at Week 12 and Week 24/Early Withdrawal minus the total score at Baseline."|Baseline, Week 12, and Week 24/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Scores on a scale||Standard Error|Least Squares Mean
819226|NCT01134042|Other Pre-specified|The Number of Participants Who Withdrew Due to Lack of Efficacy During the 24-week Treatment Period|The number of participants whose primary reason for withdrawal was lack of efficacy was analyzed.|From the first dose of the study medication up to Week 24/Early Withdrawal|ITT Population||participants|||Number
819227|NCT01134042|Other Pre-specified|Mean Change From Baseline in Daily Morning Trough (AM) and Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the First 12 Weeks and 24 Weeks of the 24-week Treatment Period|PEF is a measure of lung function and is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning and evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Trough PEF is the PEF measured approximately 24 hours after the last administration of study drug. Change from Baseline (defined as the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily trough AM/PM PEF over 12 weeks and 24 weeks of the 24-week Treatment Period (at Weeks 12 and 24) minus the Baseline value.|From Baseline up to Week 12 and Week 24|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Liters/minute (L/min)||Standard Error|Least Squares Mean
819228|NCT01134042|Other Pre-specified|Change From Baseline in Weighted Mean Serial FEV1 Over 0 to 4 Hours Post-dose at Week 24|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Serial FEV1 measurements were taken electronically by spirometry at Baseline. Weighted mean was calculated using the 4-hour serial FEV1 measurements that included the pre-dose assessment (within 5 minutes prior to dosing) and post-dose assessments after 5, 15, and 30 minutes and 1, 2, 3, and 4 hours. At each time point, the highest of 3 technically acceptable measurements was recorded. Baseline was the value obtained at Visit 3. Change from Baseline was calculated as the average Week 24 FEV1 value minus the Baseline value.|Baseline and Week 24|ITT Population. Weighted mean serial FEV1 was calculated in the subset of participants for whom serial FEV1 at Week 24 was performed.||Liters||Standard Deviation|Mean
819229|NCT01134042|Other Pre-specified|Clinic Visit 12-hour Post-dose FEV1at Week 24|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. 12-hour post-dose FEV1 measurements were taken electronically by spirometry at the Week 24 clinic visit. The highest of 3 technically acceptable measurements was recorded.|Week 24|ITT Population. 12-hour post-dose FEV1 was analyzed in the subset of participants for whom serial FEV1 at Week 24 was performed.||Liters||Standard Deviation|Mean
819303|NCT01134393|Secondary|Frequency of Patients Requiring Up-titration to Telmisartan 80mg Plus Amlodipine 10mg Combination (T80/A10) to Achieve Blood Pressure Control Over Time||weeks 4 and 8|FAS||Number of participants|||Number
819230|NCT01134042|Secondary|Change From Baseline in the Total Asthma Quality of Life Questionnaire (AQLQ) (+12) Score at Week 12 and Week 24/Early Withdrawal|"The AQLQ is a disease-specific, self-administered quality of life questionnaire used to evaluate the impact of asthma treatments on the quality of life of asthma sufferers. The AQLQ for 12 years and older (AQLQ [+12]) is a modified version of the AQLQ for use in asthma patients between the age of 12 and 70. The AQLQ contains 32 items in 4 domains: activity limitation (11 items), symptoms (12 items), emotional function (5 items), and environmental stimuli (4 items). For the 32 items on the questionnaire, the response format consists of a seven-point scale, where a value of 1 indicates “total impairment” and a value of 7 indicates “no impairment.” The AQLQ total score is defined as the average of the scores from all 32 questions; thus, the total score ranges from 1 (indicates total impairment) to 7 (indicates no impairment). Baseline was the total score obtained at Visit 3. Change from Baseline was calculated as the total score at Weeks 12 and 24 minus the total score at Baseline."|Baseline, Week 12, and Week 24/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Scores on a scale||Standard Error|Least Squares Mean
819231|NCT01134042|Secondary|Change From Baseline in the Percentage of Rescue-free and Symptom-free 24-hour Periods at the End of the 24-week Treatment Period|The number of inhalations of rescue bronchodilator, albuterol/salbutamol inhalation aerosol, used during the day and night was recorded by the participants in a daily electronic diary (eDiary). Similarly, asthma symptoms were recorded in a daily eDairy by the participants every day in the morning and evening before taking any rescue or study medication and before the peak expiratory flow measurement. A 24-hour period in which a participant’s responses to both the morning and evening assessments indicated no use of rescue medication/symptoms was considered to be rescue free/symptom free. The Baseline value was derived from the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 24-week Treatment Period minus the Baseline value.|Baseline and Week 24|ITT Population. Only those participants available at the specified time points were analyzed.||Percentage of periods||Standard Error|Least Squares Mean
819232|NCT01134042|Primary|Change From Baseline in Weighted Mean Serial FEV1 Over 0-24 Hours Post-dose at Week 24|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Serial FEV1 measurements were taken electronically by spirometry at the Baseline and Week 24 clinic visits. Weighted mean was calculated using the 24-hour serial FEV1 measurements that included the pre-dose assessment (within 5 minutes prior to dosing) and the post-dose assessments after 5, 15, and 30 minutes and 1, 2, 3, 4, 5, 12, 16, 20, 23, and 24 hours. At each time point, the highest of 3 technically acceptable measurements was recorded. Baseline was the value obtained at Visit 3. Change from Baseline was calculated as the average Week 24 FEV1 value minus the Baseline value.|Baseline and Week 24|ITT Population. Weighted mean serial FEV1 was calculated in the subset of participants for whom serial FEV1 at Week 24 was performed.||Liters||Standard Error|Least Squares Mean
819233|NCT01134042|Primary|Change From Baseline in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 24-week Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is defined as the clinic visit (pre-bronchodilator and pre-dose) FEV1 measurement taken at the clinic visit while still on treatment. Pre-dose and pre-rescue albuterol/salbutamol trough FEV1 was measured electronically by spirometry in the evening at the Baseline (BL) through Week 24 clinic visits. The highest of 3 technically acceptable measurements was recorded. BL was the pre-dose value obtained at Visit 3. Change from BL was calculated as the Week 24 value minus the Baseline value. The analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of BL trough FEV1, country, sex, age, and treatment group.The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-BL on-treatment measurement at scheduled clinic visits was used to impute the missing measurements.|Baseline and Week 24|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of the study medication. Only those participants with non-missing covariates and a post-Baseline FEV1 measurement were analyzed.||Liters||Standard Error|Least Squares Mean
819234|NCT01134081|Primary|Differences in Angiogenic Biomarkers: PDGF-BB|Within-subject difference between the concentrations at the CelTX and Free Gingival Graft areas|5 time-points: pre-surgical, week(s) 1, 2, 3 and 4|44 subjects were enrolled. All 44 subjects participated in both arms/groups for a total of 88 surgical sites. 2 surgical sites of each patient were randomly selected to receive LCC as a donor material in 1 site and a conventional autograft using keratinized tissue from the palate as the donor material at the contralateral site.||pg/mL||Standard Error|Mean
819235|NCT01134081|Primary|Differences in Angiogenic Biomarkers|Within-subject difference between the concentrations at the CelTX and Free Gingival Graft areas|5 time-points: pre-surgical, week(s) 1, 2, 3 and 4|44 subjects were enrolled. All 44 subjects participated in both arms/groups for a total of 88 surgical sites. 2 surgical sites of each patient were randomly selected to receive LCC as a donor material in 1 site and a conventional autograft using keratinized tissue from the palate as the donor material at the contralateral site.||ng/mL|Surgical sites|Standard Error|Mean
819236|NCT01134107|Other Pre-specified|Change From Baseline to 12 Weeks Endpoint for Each Treatment in Blood Pressure||Baseline, endpoint for each 12-week treatment period|All randomized participants who received at least one dose of study drug and had both baseline and post-baseline blood pressure measurements for the respective treatment period.||millimeters of mercury (mmHg)||Standard Deviation|Mean
819237|NCT01134107|Other Pre-specified|Change From Baseline to 12 Week Endpoint for Each Treatment in Weight||Baseline, endpoint for each 12-week treatment period|All randomized participants who received at least one dose of study drug and had both baseline and post-baseline weight measurements for the respective treatment period.||kilograms (kg)||Standard Deviation|Mean
819238|NCT01134107|Other Pre-specified|Hypoglycemic Episode Rate Per 30 Days|"All Reported Hypoglycemic Episodes are defined as an event which is associated with
reported signs and symptoms of hypoglycemia, and/or
a documented blood glucose (BG) concentration of <= 70 mg/dL (3.9 mmol/L)"|All days for each reservoir cycle throughout each 12-week treatment period|All randomized participants who received at least one dose of study drug. Participants included in hypoglycemia analyses are only those for whom data existed regarding hypoglycemia.||hypoglycemic episodes per 30 days||Standard Deviation|Mean
819239|NCT01134107|Other Pre-specified|Percentage of Participants Having a Hypoglycemic Episode|"A Documented Hypoglycemic Episode is defined as an event which is associated with a documented blood glucose (BG) concentration of <= 70 mg/dL (3.9 mmol/L).
All Reported Hypoglycemic Episodes are defined as an event which is associated with
reported signs and symptoms of hypoglycemia, and/or
a documented blood glucose (BG) concentration of <= 70 mg/dL (3.9 mmol/L)"|All days for each reservoir cycle throughout each 12-week treatment period|All randomized participants who received at least one dose of study drug. Participants included in hypoglycemia analyses are only those for whom data existed regarding hypoglycemia.||percentage of participants|||Number
819240|NCT01134107|Other Pre-specified|Pump Complications Rate Per 30 Days|Overall pump complications are defined as any combination of the following reported by the participant: tubing clogged, tubing kinked, tubing disconnect, tubing pulled out, blood in tubing, too much heat, too much cold, empty reservoir, low battery, occlusion alarm, no delivery alarm, skin abscess at site, excessive redness at site, swelling (not nodule) at site, bleeding at site, bruising at site, reservoir change (infusion set change reason only), and other. When either a reservoir change or an infusion set change was reported, participants were questioned whether the change occurred early (prior to 6 days). If he/she responded 'yes', then the reported change was recorded as a premature change.|Days 1-6 for each reservoir cycle throughout each 12-week treatment period|All randomized participants who completed at least one post-randomization visit. Participants included in pump complication analyses are only those for whom data existed regarding pump complications.||pump complications per 30 days||Standard Deviation|Mean
819241|NCT01134107|Other Pre-specified|Percentage of Participants With Pump Complications|Overall pump complications are defined as any combination of the following, reported by the participant: tubing clogged, tubing kinked, tubing disconnect, tubing pulled out, blood in tubing, too much heat, too much cold, empty reservoir, low battery, occlusion alarm, no delivery alarm, skin abscess at site, excessive redness at site, swelling (not nodule) at site, bleeding at site, bruising at site, reservoir change (infusion set change reason only), and other. When either a reservoir change or an infusion set change was reported, participants were questioned whether the change occurred early (prior to 6 days). If he/she responded 'yes', then the reported change was recorded as a premature change.|Days 1-6 for each reservoir cycle throughout each 12-week treatment period|All randomized participants who completed at least one post-randomization visit. Participants included in pump complication analyses are only those for whom data existed regarding pump complications.||percentage of participants|||Number
819242|NCT01134107|Other Pre-specified|Hyperglycemic Episode Rate Per 30 Days|Hyperglycemia was defined as an episode with (1) a measured blood glucose concentration >250 milligrams per deciliter [mg/dL] (13.9 millimoles per liter [mmol/L]) and ≥3 hours after eating, or (2) a measured blood glucose concentration >300 mg/dL (16.7 mmol/L) and <3 hours after eating. Rate is presented as the number of hyperglycemic episodes adjusted for 30 days.|Days 1-6 for each reservoir cycle throughout each 12-week treatment period|All randomized participants who received at least one dose of study drug. Participants included in hyperglycemia analyses are only those for whom data existed regarding hyperglycemia.||hyperglycemic episodes per 30 days||Standard Deviation|Mean
819243|NCT01134107|Other Pre-specified|Percentage of Participants Having a Hyperglycemic Episode|A hyperglycemic episode was defined as an event with (1) a measured blood glucose concentration >250 milligrams per deciliter (mg/dL) (13.9 millimoles per liter [mmol/L]) and ≥3 hours after eating, or (2) a measured blood glucose concentration >300 mg/dL (16.7 mmol/L) and <3 hours after eating|Days 1-6 for each reservoir cycle throughout each 12-week treatment period|All randomized participants who received at least one dose of study drug. Participants included in hyperglycemia analyses are only those for whom data existed regarding hyperglycemia.||percentage of participants|||Number
819244|NCT01134107|Other Pre-specified|Change From Baseline to 12 Weeks for Daily Insulin Dose (Total, Basal, and Bolus)||Baseline, endpoint for each 12-week treatment period|All randomized participants who completed at least one post-randomization visit. Participants included in insulin analyses are only those for whom data existed regarding insulin dose.||Units (U) of insulin||Standard Deviation|Mean
819245|NCT01134107|Secondary|Number of Participants Who Achieve or Maintain a Glycated Hemoglobin A1c (HbA1c) Less Than or Equal to 6.5% and Less Than 7%||Endpoint for each 12-week treatment period|All randomized participants who completed a post-randomization visit and had an HbA1c measurement for the respective treatment period.||participants|||Number
819246|NCT01134107|Secondary|Change From Baseline to 12 Weeks for Each Treatment in Glycated Hemoglobin A1c (HbA1c) Values||Baseline, endpoint for each 12-week treatment period|All randomized participants who completed at least one post-randomization visit, and had a baseline and a post-randomization HbA1c measurement for the respective treatment period. Last Observation Carried Forward (LOCF) method was utilized in this analysis.||percentage of HbA1c||Standard Deviation|Mean
819247|NCT01134107|Secondary|Mean Daily Insulin Dose (Total, Basal, and Bolus)||Days 1-6 for each reservoir cycle throughout each 12-week treatment period|All randomized participants who completed at least one post-randomization visit. Participants included in insulin analyses are only those for whom data existed regarding insulin dose.||Units (U) of insulin||Standard Deviation|Mean
819248|NCT01134107|Secondary|Mean SMBG|Mean SMBG for combined periods; all reported SMBG values on Days 1-6, Day 2, and Day 6 for Insulin Lispro 6D and Insulin Aspart 6D.|Days 1-6 and Day 2 and Day 6 for each reservoir cycle throughout each 12-week treatment period|All randomized participants who completed at least one post-randomization visit and one SMBG measurement on a Day 6, or Day 2 depending on the analysis, for the respective treatment arm: insulin lispro 6D and insulin aspart 6D.||millimoles per liter (mmol/L)||Standard Deviation|Mean
819249|NCT01134107|Primary|Mean of Last Six 7-point Self Monitored Blood Glucose (SMBG) Taken on Day 6 for Insulin Lispro 6D and Insulin Aspart 6D Pump Reservoir In-use||Day 6 of each reservoir cycle for the last 6 weeks of each 12-week treatment period (Week 7 through Week 12)|All randomized participants who completed at least one post-randomization visit. Those included in the primary analysis had to have at least one reservoir in-use cycle with an SMBG measurement on Day 6 during the pre-specified collection period.||millimoles per liter (mmol/L)||Standard Deviation|Mean
819250|NCT01126268|Secondary|Number of Participants Reporting Any Adverse Event (AE)|AEs included burning at application site, upper respiratory infection, furuncle, cough, and a rash at a site other than the application site. See the Adverse Events section for more detailed information.|baseline to 6 to 8 days after treatment|All participants who received at least 1 dose of Retapamulin (Altabax)||participants|||Number
819255|NCT01126268|Secondary|Tissue Warmth (Sign and Symptom of Infection) at Follow up|Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.|6 to 8 days after treatment|All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing||participants|||Number
819256|NCT01126268|Secondary|Tissue Warmth (Sign and Symptom of Infection) at Baseline|Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.|baseline|All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing||participants|||Number
819257|NCT01126268|Secondary|Tissue Edema (Sign and Symptom of Infection) at Follow up|Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.|6 to 8 days after treatment|All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing||participants|||Number
819258|NCT01126268|Secondary|Tissue Edema (Sign and Symptom of Infection) at Baseline|Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.|baseline|All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing||participants|||Number
819259|NCT01126268|Secondary|Crusting (Sign and Symptom of Infection) at Follow up|Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.|6 to 8 days after treatment|All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing||participants|||Number
819260|NCT01126268|Secondary|Crusting (Sign and Symptom of Infection) at Baseline|Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.|baseline|All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing||participants|||Number
819261|NCT01126268|Secondary|Purulence (Sign and Symptom of Infection) at Follow up|Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.|6 to 8 days after treatment|All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing||participants|||Number
819262|NCT01126268|Secondary|Purulence (Sign and Symptom of Infection) at Baseline|Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.|baseline|All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing||participants|||Number
819263|NCT01126268|Secondary|Erythema (Sign and Symptom of Infection) at Follow up|Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.|6 to 8 days after treatment|All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing||participants|||Number
819264|NCT01126268|Secondary|Erythema (Sign and Symptom of Infection) at Baseline|Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.|baseline|All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing||participants|||Number
819265|NCT01126268|Secondary|Number of Participants Who Were a Therapeutic Success|Therapeutic response was determined from the clinical response and the microbiological response. Patients who qualified as both a “clinical success” and a “microbiological success” were deemed a “therapeutic success,” and all others were deemed “therapeutic failures.”|6 to 8 days after treatment|All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing||participants|||Number
819266|NCT01126268|Secondary|Microbiologic Response at Follow up as Assessed by a Rating Scale|Microbiological response was determined by the investigator at the follow-up visit using the following microbiological outcomes: (1) microbological eradication, (2) presumed microbiological eradication, (3) presumed microbiological improvement, (4) microbiological persistence, (5) presumed microbiological persistence, (6) unable to determine, (7) new pathogen, and (8) colonization. Patients who were designated microbiological eradication, presumed microbiological eradication, presumed microbiological improvement, or colonization as defined in numbers 1, 2, 3, and 8 above were considered a “microbiological success” while all others were considered “microbiological failure.”|6 to 8 days after treatment|All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing||participants|||Number
819267|NCT01126268|Secondary|Clinical Response at Follow up as Assessed by a Rating Scale|Clinical response was based on clinical evaluation by the investigator at the follow-up visit using a predefined scale with the following categories: (1) clinical success, (2) clinical improvement, (3) no change, (4) clinical failure, and (5) unable to determine. Patients who were designated as clinical success as defined in number 1 above were considered a true “clinical success” while all others were considered a “clinical failure.” Patients were classified with an outcome of “unable to determine” if they missed their follow-up visit or refused clinical examination.|6 to 8 days after treatment|All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing||participants|||Number
819268|NCT01126268|Primary|Number of Participants Whose Wound Cultures Were Positive for MRSA and Who Were Determined to be a Clinical Success at the Follow-up Visit|Clinical success is defined as no further signs or symptoms of infection present, including erythema, purulence, crusting, edema, warmth and pain.|6 to 8 days after treatment|Participants whose wound cultures were positive for MRSA||participants|||Number
819269|NCT01134276|Secondary|Total Hospital Cost During Admission After Biliary Drainage|Total hospital cost during admission after Biliary Drainage in US dollars|during hospital stay for biliary drainage procedure|||thousands in US dollars||Standard Deviation|Mean
819270|NCT01134276|Secondary|Change in Total Serum Bilirubin After Drainage|Effect of reducing serum total bilirubin after drainage in terms of Daily diminution of bilirubin(mg/dL/day)|within 14 days after drainage|||mg/dL/day||Standard Deviation|Mean
819271|NCT01134276|Primary|Incidence of Infectious Complications After Biliary Drainage|at least 90 days after operation change in serum bilirubin cholangitis blood test (complete blood cell count, liver function test, CRP)|within 120 days after drainage|||participants|||Number
819272|NCT01134315|Secondary|Mean Baseline and Change From Baseline in Albumin at Final Visit (FV)|Normal ranges for these chemistry measurements varied according to the age of the participant.|Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])|All Treated Population (all participants who received at least 1 dose of paricalcitol [paricalcitol group] or at least one dose of calcitriol [calcitriol group]) with measurements at baseline and given time point.||g/dL||Standard Deviation|Mean
819273|NCT01134315|Secondary|Mean Baseline and Change From Baseline in Parathyroid Hormone at Final Visit (FV)|Normal ranges for these chemistry measurements varied according to the age of the participant.|Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])|All Treated Population (all participants who received at least 1 dose of paricalcitol [paricalcitol group] or at least one dose of calcitriol [calcitriol group]) with measurements at baseline and given time point.||pg/mL||Standard Deviation|Mean
819274|NCT01134315|Secondary|Mean Baseline and Change From Baseline in 1,25-Dihydroxy Vitamin D3 at Final Visit (FV)|Normal ranges for these chemistry measurements varied according to the age of the participant.|Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])|All Treated Population (all participants who received at least 1 dose of paricalcitol [paricalcitol group] or at least one dose of calcitriol [calcitriol group]) with measurements at baseline and given time point.||pg/mL||Standard Deviation|Mean
819275|NCT01134315|Secondary|Mean Baseline and Change From Baseline in 25-Hydroxy Vitamin D3 at Final Visit (FV)|Normal ranges for these chemistry measurements varied according to the age of the participant.|Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])|All Treated Population (all participants who received at least 1 dose of paricalcitol [paricalcitol group] or at least one dose of calcitriol [calcitriol group]) with measurements at baseline and given time point.||ng/mL||Standard Deviation|Mean
819276|NCT01134315|Secondary|Mean Baseline (BL) and Change From Baseline in Calcium, Inorganic Phosphate (IP), Blood Urea Nitrogen (BUN), Creatinine at Final Visit (FV)|Normal ranges for these chemistry measurements varied according to the age of the participant.|Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])|All Treated Population (all participants who received at least 1 dose of paricalcitol [paricalcitol group] or at least one dose of calcitriol [calcitriol group]); n=number of participants with measurements at baseline and given time point.||mg/dL||Standard Deviation|Mean
819277|NCT01134315|Secondary|Mean Baseline (BL) and Change From Baseline in Potassium, Sodium, Chloride, Bicarbonate at Final Visit (FV)|Normal ranges for these chemistry measurements varied according to the age of the participant.|Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])|All Treated Population (all participants who received at least 1 dose of paricalcitol [paricalcitol group] or at least one dose of calcitriol [calcitriol group]); n=number of participants with measurements at baseline and given time point.||mEq/L||Standard Deviation|Mean
819278|NCT01134315|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), Deaths and Discontinuations Due to AEs|AE: any untoward medical occurrence that does not necessarily have a causal relationship with treatment; any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered causally related to the use of the product (either paricalcitol or calcitriol); can result from use of the drug as stipulated in the labeling, as well as from accidental or intentional overdose, drug abuse, or drug withdrawal; any worsening of a pre-existing condition or illness. Severity was categorized as mild, moderate, or severe. SAE: AE that results in the death; is life-threatening; results in hospitalization or prolongation of hospitalization; is a congenital anomaly; results in persistent or significant disability/incapacity; is an important medical event requiring medical or surgical intervention to prevent serious outcome; is a spontaneous or elective abortion. For more details, please see the AE section of this record.|Monitored from time of informed consent through end of study + 30 days (total of 745 days).|All participants||participants|||Number
819279|NCT01134315|Primary|Percentage of Participants With at Least One Incidence of Hypercalcemia|Hypercalcemia was defined as calcium >10.2 mg/dL. Percentage of participants with hypercalcemia is presented for the overall population, the subgroup of participants in the study for less than 3 months, and those in the study for greater than or equal to 3 months.|Monitored from time of informed consent through end of study + 30 days (total of 745 days).|All Treated Population (all participants who received at least 1 dose of paricalcitol [paricalcitol group] or at least one dose of calcitriol [calcitriol group]).||percentage of participants|||Number
819280|NCT01134328|Secondary|Tolerability of Study Medication at Visit 3|Subjects were asked to rate the comfort of the drop in each eye upon instillation, at 1 minute, and at 2 minutes after instillation of study medication. The assessment used a 10-point scale with 0 as very comfortable and 10 as very uncomfortable. Higher scores represent a worse outcome.|upon instillation, 1 minute and 2 minutes post instillation|Intent to Treat (ITT)||units on a scale||Standard Deviation|Mean
819281|NCT01134328|Secondary|Tolerability of Study Medication at Visit 2B|Subjects were asked to rate the comfort of the drop in each eye upon instillation, at 1 minute, and at 2 minutes after instillation of study medication. The assessment used a 10-point scale with 0 as very comfortable and 10 as very uncomfortable. Higher scores represent a worse outcome.|upon instillation, 1 minute and 2 minutes post instillation|Intent to Treat (ITT). Number of analyzed subjects differ due to subject discontinuation during the study.||units on a scale||Standard Deviation|Mean
819282|NCT01134328|Secondary|Ear or Palate Pruritus at 8 Hours Post-dose at Visit 4A|A treatment efficacy CAC was performed 15 minutes after drop instillation. Ear or Palate Pruritus was assessed by the patient on a single 0-4 scale (0=none to 4=severe). Ear or Palate Pruritus score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Per protocol population||units on a scale||Standard Deviation|Mean
819283|NCT01134328|Secondary|Ear or Palate Pruritus at Duration of Action (16 Hours Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Ear or Palate Pruritus was assessed by the patient on a single 0-4 scale (0=none to 4=severe). Ear or Palate Pruritus score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Per protocol population||units on a scale||Standard Deviation|Mean
819284|NCT01134328|Secondary|Ear or Palate Pruritus at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Ear or Palate Pruritus was assessed by the patient on a single 0-4 scale (0=none to 4=severe). Ear or Palate Pruritus score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Per protocol population||units on a scale||Standard Deviation|Mean
819285|NCT01134328|Secondary|Lid Swelling at 8 Hours Post-dose at Visit 4A|A treatment efficacy CAC was performed 8 hours after drop instillation. Lid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of lid swelling score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Per protocol population||units on a scale||Standard Deviation|Mean
819700|NCT01130597|Secondary|Percentage of Participants Discontinuing Due to Hyperkalemia (Serum Potassium > 5.5 mEq/L)||56 Days|||percentage of participants|||Number
819286|NCT01134328|Secondary|Lid Swelling Duration of Action (16 Hours Post-dose)|A treatment efficacy CAC was performed 16 hours after drop instillation. Lid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of lid swelling score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Per protocol population||units on a scale||Standard Deviation|Mean
819287|NCT01134328|Secondary|Lid Swelling at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Lid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of lid swelling score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Per protocol population||units on a scale||Standard Deviation|Mean
819288|NCT01134328|Secondary|Total Redness at 8 Hours Post-Dose at Visit 4A|A treatment efficacy CAC was performed 8 hours after drop instillation. Total redness was defined as the sum of the conjunctival, ciliary and episcleral redness scores, and was, thus, on a 0-12 scale, making the threshold for clinical significance a treatment difference of 3.0 units. Higher scores represent greater severity.|7, 15, 20 minutes post-CAC|Per protocol population||units on a scale||Standard Deviation|Mean
819289|NCT01134328|Secondary|Total Redness at Duration of Action (16 Hours Post-dose)|A treatment efficacy CAC was performed 16 hours after drop instillation. Total redness was defined as the sum of the conjunctival, ciliary and episcleral redness scores, and was, thus, on a 0-12 scale, making the threshold for clinical significance a treatment difference of 3.0 units. Higher scores represent greater severity.|7, 15, 20 minutes post-CAC|Per protocol population||units on a scale||Standard Deviation|Mean
819290|NCT01134328|Secondary|Total Redness at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Total redness was defined as the sum of the conjunctival, ciliary and episcleral redness scores, and was, thus, on a 0-12 scale, making the threshold for clinical significance a treatment difference of 3.0 units. Higher scores represent greater severity.|7, 15, 20 minutes post-CAC|Per protocol population||units on a scale||Standard Deviation|Mean
819291|NCT01134328|Secondary|Episcleral Redness at 8 Hours Post-dose at Visit 4A|A treatment efficacy CAC was performed 8 hours after drop instillation. Episcleral Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of episcleral redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Per protocol population||units on a scale||Standard Deviation|Mean
819292|NCT01134328|Secondary|Episcleral Redness at Duration of Action (16 Hours Post-dose)|A treatment efficacy CAC was performed 16 hours after drop instillation. Episcleral Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of Episcleral redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Per protocol population||units on a scale||Standard Deviation|Mean
819293|NCT01134328|Secondary|Episcleral Redness at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Episcleral Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of episcleral redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Per protocol population||units on a scale||Standard Deviation|Mean
819294|NCT01134328|Secondary|Ciliary Redness at 8 Hours Post-dose at Visit 4A|A treatment efficacy CAC was performed 8 hours after drop instillation. Ciliary Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ciliary redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Per protocol population||units on a scale||Standard Deviation|Mean
819295|NCT01134328|Secondary|Ciliary Redness at Duration of Action (16 Hours Post-dose)|A treatment efficacy CAC was performed 16 hours after drop instillation. Ciliary Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ciliary redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Per protocol population||units on a scale||Standard Deviation|Mean
819296|NCT01134328|Secondary|Ciliary Redness at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Ciliary Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ciliary redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Per protocol population||units on a scale||Standard Deviation|Mean
819297|NCT01134328|Primary|Conjunctival Redness at 8 Hours Post-dose at Visit 4A|A treatment efficacy CAC was performed 8 hours after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT) Population with Last Observation Carried Forward (LOCF)||units on a scale||Standard Deviation|Mean
819298|NCT01134328|Primary|Conjunctival Redness at Duration of Action (16 Hours Post-dose)|A treatment efficacy CAC was performed 16 hours after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT) Population with Last Observation Carried Forward (LOCF)||units on a scale||Standard Deviation|Mean
819299|NCT01134328|Primary|Conjunctival Redness at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT) Population with Last Observation Carried Forward (LOCF)||units on a scale||Standard Deviation|Mean
819300|NCT01134328|Primary|Ocular Itching at 8 Hours Post-dose at Visit 4A|A treatment efficacy CAC was performed 8 hours after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.|3, 5, 7 minutes post-CAC|Intent to Treat (ITT) Population with Last Observation Carried Forward (LOCF)||units on a scale||Standard Deviation|Mean
819301|NCT01134328|Primary|Ocular Itching at Duration of Action (16 Hours Post-dose)|A treatment efficacy CAC was performed 16 hours after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.|3, 5, 7 minutes post-CAC|Intent to Treat (ITT) Population with Last Observation Carried Forward (LOCF)||units on a scale||Standard Deviation|Mean
819302|NCT01134328|Primary|Ocular Itching at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.|3, 5, 7 minutes post-CAC|Intent to Treat (ITT)||units on a scale||Standard Deviation|Mean
819701|NCT01130597|Secondary|Mean Change From Baseline in Serum Potassium to End of Treatment||56 Days|||mEq/L||Standard Deviation|Mean
819304|NCT01134393|Secondary|DBP and SBP Control and Response Rates Morning and Evening Over Time HBPM Measurements|DBP control: DBP <85 mmHg, SBP control: SBP <135 mmHg, DBP response: DBP <85 mmHg or a reduction from baseline >=10 mmHg, SBP response: SBP <135 mmHg or a reduction from baseline >= 15 mmHg|weeks 4, 8 and 12|FAS and LOCF and with at least one post baseline HBPM measurement||Number of participants|||Number
819305|NCT01134393|Secondary|Percentage of Patients in Blood Pressure Categories Over Time|BP optimal: SBP <120 mmHg and DBP <80 mmHg, BP normal: SBP <130 mmHg and DBP <85 mmHg but not optimal, BP high-normal: SBP <140 mmHg and DBP <90 mmHg but not normal. Grade 1 hypertension: SBP <160 mmHg and DBP <100 mmHg but not high-normal, Grade 2 hypertension: SBP <180 mmHg and DBP <110 mmHg but not grade 1, Grade 3 hypertension: SBP >=180 mmHg or DBP >=110 mmHg.|weeks 4, 8 and 12|FAS with non-missing data||Percentage of participants|||Number
819306|NCT01134393|Secondary|DBP and SBP Control and Response Rates After 4, 8 and 12 Weeks of Treatment Using In-clinic BP Measurements|DBP control is defined as DBP <90 mmHg or <80 mmHg in patients with diabetes or renal impairment. SBP control is defined as SBP <140 mmHg or <130 mmHg in patients with diabetes or renal impairment. DBP response is defined as DBP <90 mmHg or <80 mmHg in patients with diabetes or renal impairment or a reduction from baseline >=10mmHg. SBP response is defined as SBP<140 mmHg or <130 mmHg in patients with diabetes or renal impairment or a reduction from baseline >=15mmHg.|weeks 4, 8 and 12|FAS and LOCF||Number of participants|||Number
819307|NCT01134393|Secondary|Change From Baseline Over Time in In-clinic Measured Mean Pulse Pressure||weeks 4, 8 and 12|There was no information in the Case Report Form (CRF)|||||
819308|NCT01134393|Secondary|Change From Baseline Over Time in In-clinic Measured Mean Pulse Rate|Pulse pressure was not analysed for this study instead pulse rate was analysed at weeks 4, 8 and 12.|weeks 4, 8 and 12|Treated Set (TS) with non-missing data||bpm||Standard Deviation|Mean
819309|NCT01134393|Secondary|Change From Baseline Over Time in In-clinic Measured Mean SBP and Mean DBP||weeks 4, 8 and 12|FAS with non-missing data||mmHg||Standard Deviation|Mean
819310|NCT01134393|Secondary|BP Control (Morning and Evening) After 12 Weeks of Treatment Using Home Blood Pressure Measurement (HBPM).|Achieving BP control with HBPM is defined as SBP<135 mmHg and DBP<85 mmHg.|Week 12|FAS and LOCF and with at least one post baseline HBPM measurement||Number of participants|||Number
819311|NCT01134393|Secondary|BP Control After 4 and 8 Weeks of Treatment Using In-clinic BP Measurements.|Achieving BP control is defined as SBP<140 mmHg and DBP<90 mmHg.|4 and 8 weeks|FAS and LOCF||Number of participants|||Number
819312|NCT01134393|Primary|Percentage of Patients Achieving Blood Pressure (BP) Control After 12 Weeks of Treatment Using In-clinic BP Measurements.|Achieving BP control is defined as SBP<140 mmHg and DBP<90 mmHg.|12 weeks|Full Analysis Set (FAS) is defined as all patients who took at least one dose of trial medication, and for whom a baseline measurement and at least one post-baseline efficacy measurement were available. Last observation carried forward (LOCF) will be used.||Percentage of participants||95% Confidence Interval|Number
819313|NCT01134510|Secondary|Donor Specific Antibodies [DSA] Class II|"Donor Specific Antibodies [DSAs] Class I will be checked 1, 3, and 6 months post transplant to monitor allograft function.
DSA will be measured using a relative intensity score (RIS) ranges from 0 points = No DSA; 2 points = <5000MFI (weak intensity); 5 points = 5000-10,000 MFI (moderate intensty); 10 points = >10,000MFI (strong intensity). Each DSA can have a score of 10 maximum. However, patients may have more than one DSA and points can add up to more than 10. this depends on how many DSAs [Class I and/or Class II] are present at the time of transplant and quarterly after transplant.
However, patients may have more than one DSA and points can add up to more than 10 this depends on how many DSAs [Class I and/or Class II] are present at the time of transplant and quarterly after transplant. Patients can have an infinite number of donor specific antibodies, this score can be higher than 10."|6 months|Mean Donor Specific Antibody (DSA) Class II levels at 1, 3, and 6 month post-transplant from 10 patients in the C1 Esterase Inhibitor group and 10 patients in the placebo group were calculated.||DSA relative intensity score||Standard Deviation|Mean
819314|NCT01134510|Secondary|Donor Specific Antibodies [DSA] Class I|"Donor Specific Antibodies [DSAs] Class I will be checked 1, 3, and 6 months post transplant to monitor allograft function.
DSA will be measured using a relative intensity score (RIS) ranges from 0 points = No DSA; 2 points = <5000MFI (weak intensity); 5 points = 5000-10,000 MFI (moderate intensty); 10 points = >10,000MFI (strong intensity). Each DSA can have a score of 10 maximum. However, patients may have more than one DSA and points can add up to more than 10. this depends on how many DSAs [Class I and/or Class II] are present at the time of transplant and quarterly after transplant. Patients can have an infinite number of donor specific antibodies, this score can be higher than 10."|6 months|Mean Donor Specific Antibody Class I levels at 1, 3, and 6 month post-transplant from 10 patients in the C1 Esterase Inhibitor group and 10 patients in the placebo group were calculated.||DSA relative intensity score||Standard Deviation|Mean
819315|NCT01134510|Secondary|Serum Creatinine|Serum creatinine will be checked 6 months post transplant to monitor allograft function.|6 months|Mean serum creatinine levels at 6 month post-transplant from 10 patients in the C1 Esterase Inhibitor group and 10 patients in the placebo group were calculated.||mg/dl (serum cr at 6m post transplant)||Standard Deviation|Mean
819316|NCT01134510|Primary|Post-transplant Biopsy to Identify Rejection Episodes|"Subjects will have a routine kidney biopsy 6 month after transplant to screen for episodes of acute rejection.
For purposes of this investigation, antibody-mediated rejection (AMR) is defined as follows:
Deterioration of allograft function in a high-risk transplant recipient (i.e. sensitized patient with history of Donor Specific Antibodies) measured by serum Creatinine and estimated Glomerular Filtration Rate
Association with the presence of Donor Specific Antibody (usually increasing in strength) measured by luminex techniques.
Biopsy evidence of capillaritis, inflammation and C4d deposition."|6 month|9 patients in each arm completed 6 month protocol biopsy. 1 patient in the placebo arm was withdrawn before 6M biopsy. 1 patient in treatment arm refused protocol biopsy.||Episode of rejection|||Number
819317|NCT01135992|Secondary|Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of nocturnal confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes with a confirmed plasma glucose value of less than 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occuring between 00:01 and 05:59 a.m.|Weeks 0-4 (IGlar), Weeks 4-16 (IDeg 3TW)|Safety Analysis Set includes all subjects who received at least one dose of the investigational product or its comparator||episodes per 100 patient years|||Number
819702|NCT01130597|Secondary|Mean Patiromer Dose at Week 8||Up to Week 8|||grams||Standard Deviation|Mean
819318|NCT01135992|Secondary|Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes with a confirmed plasma glucose value of less than 3.1 mmol/L.|Weeks 0-4 (IGlar), Weeks 4-16 (IDeg 3TW)|Safety Analysis Set includes all subjects who received at least one dose of the investigational product or its comparator.||episodes per 100 patient years|||Number
819319|NCT01135992|Secondary|Rate of Treatment Emergent Adverse Events (AEs)|Corresponds to rate of AEs per 100 patient years of exposure. Mild AEs: no or transient symptoms, no interference with subject’s daily activities. Moderate AEs: marked symptoms, moderate interference with subject’s daily activities. Severe AEs: considerable interference with subject’s daily activities, unacceptable. Serious adverse event (SAE): AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect|Weeks 0-4 (IGlar), Weeks 4-16 (IDeg 3TW)|Safety Analysis Set includes all subjects who received at least one dose of the investigational product or its comparator.||events per 100 patient years|||Number
819320|NCT01135992|Secondary|Change in Body Weight|Change from baseline in body weight after week 4 and after week 16|Week 0, Week 4, Week 16|Safety Analysis Set includes all subjects who received at least one dose of the investigational product or its comparator. Missing data is imputed using LOCF (last observation carried forward)||kg||Standard Deviation|Mean
819321|NCT01135992|Secondary|Fasting Plasma Glucose (FPG)|FPG at week 4 and 16|Week 4 and Week 16|FAS (Full Analysis Set) includes all subjects that were switched to IDeg 3TW treatment||mmol/L||Standard Deviation|Mean
819322|NCT01135992|Primary|HbA1c (Glycosylated Haemoglobin)|HbA1C at week 4 and 16|Week 4 and Week 16|FAS (Full Analysis Set) includes all subjects that were switched to IDeg 3TW treatment||percentage of glycosylated haemoglobin||Standard Deviation|Mean
819323|NCT01136174|Secondary|Lung Function Measurement: Forced Vital Capacity Percent of Predicted (%FVC)|Change in Forced Vital Capacity percent of predicted (%FVC) from baseline to day 35. Only the results for placebo and Nintedanib 150mg arm were reported for this endpoint as nintedanib 150mg is the target dose.|baseline and day 35|Treated set||% predicted||Standard Deviation|Mean
819324|NCT01136174|Secondary|Lung Function Measurement: Forced Vital Capacity (FVC)|Change in forced vital capacity (FVC) from baseline to day 35. Only the results for placebo and Nintedanib 150mg arm were reported for this endpoint as nintedanib 150mg is the target dose.|baseline and day 35|Treated set||Liter||Standard Deviation|Mean
819325|NCT01136174|Secondary|Lung Function Measurement: Forced Expiratory Volume in 1 Second (FEV1)|Change in forced expiratory volume in 1 second (FEV1) from baseline to day 35. Only the results for placebo and Nintedanib 150mg arm were reported for this endpoint as nintedanib 150mg is the target dose.|baseline and day 35|Treated set||Liter||Standard Deviation|Mean
819326|NCT01136174|Secondary|Lung Function Measurement: Diffusing Capacity for Carbon Monoxide Percent of Predicted (%DLco)|Change in Diffusing Capacity for Carbon Monoxide percent of predicted (%DLco) from baseline to day 35. Only the results for placebo and Nintedanib 150mg arm were reported for this endpoint as nintedanib 150mg is the target dose.|baseline and day 35|Treated set- Only patients with valid measurements were analysed.||% predicted||Standard Deviation|Mean
819327|NCT01136174|Secondary|Lung Function Measurement: Diffusing Capacity for Carbon Monoxide (DLco)|Change in diffusing capacity for carbon monoxide (DLco) from baseline to day 35. Only the results for placebo and Nintedanib 150mg arm were reported for this endpoint as nintedanib 150mg is the target dose.|baseline and day 35|Treated set||mL/min/mmHg||Standard Deviation|Mean
819328|NCT01136174|Secondary|Change From Baseline in Pulse Rate|Change from baseline in pulse rate at day 35. Only the results for placebo and Nintedanib 150mg arm were reported for this endpoint as nintedanib 150mg is the target dose.|baseline and day 35|Treated set||bpm||Standard Deviation|Mean
819329|NCT01136174|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Change from baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at day 35. Only the results for placebo and Nintedanib 150mg arm were reported for this endpoint as nintedanib 150mg is the target dose.|baseline and day 35|Treated set||mmHg||Standard Deviation|Mean
819330|NCT01136174|Secondary|Clinical Relevant Abnormalities in Laboratory Parameters- With Pirfenidone Background|Number of patients with Clinical Relevant Abnormalities in laboratory parameters reported as adverse events - With pirfenidone background|after the first drug intake until 28 days from the last treatment administration, up to 60 days|Treated set||participants|||Number
819331|NCT01136174|Secondary|Clinical Relevant Abnormalities in Laboratory Parameters- No Pirfenidone Background|Number of patients with Clinical Relevant Abnormalities in laboratory parameters reported as adverse events - No pirfenidone background|after the first drug intake until 28 days from the last treatment administration, up to 60 days|Treated set||participants|||Number
819332|NCT01136174|Secondary|Withdrawal Due to Adverse Event|Number of patients prematurely discontinued from trial medication due to adverse event.|after the first drug intake until 28 days from the last treatment administration, up to 60 days|Treated set||participants|||Number
819333|NCT01136174|Secondary|Cmax,ss After Multiple Doses of Pirfenidone 600 mg With BIBF 1120 (After Lunch)|Maximum measured concentration of the analyte in plasma at steady state was identified from measurements obtained at multiple time points after multiple doses of Pirfenidone 600 mg with BIBF 1120 (after lunch)|Day 14 at Visit 5 (BIBF 1120 50mg and 100mg) and day 28 (visit 7) (BIBF 1120 150mg): at pre-dose and 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h after lunch dose|Treated set- Only patients with valid final pharmacokinetic values were analysed||ng/mL||Geometric Coefficient of Variation|Geometric Mean
819334|NCT01136174|Secondary|AUC0-8,ss After Multiple Doses of Pirfenidone 600 mg With BIBF 1120 (After Lunch)|AUC0-8,ss was calculated as the area under the concentration-time curve of the concentration-time profile of the analyte in plasma at steady state over the time interval from 0 to 8 hours after multiple doses of Pirfenidone 600 mg with BIBF 1120 (after lunch) in the time frame mentioned.|Day 14 at Visit 5 (BIBF 1120 50mg and 100mg) and day 28 (visit 7) (BIBF 1120 150mg): at pre-dose and 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h after lunch dose|Treated set- Only patients with valid final pharmacokinetic values were analysed||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
819496|NCT01137071|Secondary|1-year Disease Progression-free Survival Rate||1 year from the beginning of platinum-based rescue chemotherapy start date|In the ITT (Intention-to-treat) population, 25 patients out of the 29 considered for the PFS2 analysis presented disease progression or death and 4 were censored.||percentage of participants|||Number
819335|NCT01136174|Secondary|Cmax,ss After Multiple Doses of Pirfenidone 600 mg Without BIBF 1120 (After Lunch)|Maximum measured concentration of the analyte in plasma at steady state was identified from measurements obtained at multiple time points after multiple doses of Pirfenidone 600 mg Without BIBF 1120 (after lunch)|Day -1 at Visit 1: at pre-dose and 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h after lunch dose|Treated set- Only patients with valid final pharmacokinetic values were analysed||ng/mL||Geometric Coefficient of Variation|Geometric Mean
819336|NCT01136174|Secondary|AUC0-8,ss After Multiple Doses of Pirfenidone 600 mg Without BIBF 1120 (After Lunch)|AUC0-8,ss was calculated as the area under the concentration-time curve of the concentration-time profile of the analyte in plasma at steady state over the time interval from 0 to 8 hours after multiple doses of Pirfenidone 600 mg without BIBF 1120 (after lunch) in the time frame mentioned.|Day -1 at Visit 1: at pre-dose and 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h after lunch dose|Treated set- Only patients with valid final pharmacokinetic values were analysed||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
819337|NCT01136174|Secondary|Cmax,ss After Multiple Doses of Pirfenidone 600 mg With BIBF 1120 (After Breakfast)|Maximum measured concentration of the analyte in plasma at steady state was identified from measurements obtained at multiple time points after multiple doses of Pirfenidone 600 mg with BIBF 1120 (after breakfast)|Day 14 at Visit 5 (BIBF 1120 50mg and 100mg) and day 28 (visit 7) (BIBF 1120 150mg): At pre-dose and 0.5 h, 1 h, 2 h, 3 h after morning dose and pre-dose after lunch dose|Treated set- Only patients with valid final pharmacokinetic values were analysed||ng/mL||Geometric Coefficient of Variation|Geometric Mean
819338|NCT01136174|Secondary|AUC0-4,ss After Multiple Doses of Pirfenidone 600 mg With BIBF 1120 (After Breakfast)|AUC0-4,ss was calculated as the area under the concentration-time curve of the concentration-time profile of the analyte in plasma at steady state over the time interval from 0 to 4 hours after multiple doses of Pirfenidone 600 mg with BIBF 1120 (after breakfast) in the time frame mentioned.|Day 14 at Visit 5 (BIBF 1120 50mg and 100mg) and day 28 (visit 7) (BIBF 1120 150mg): At pre-dose and 0.5 h, 1 h, 2 h, 3 h after morning dose and pre-dose after lunch dose|Treated set- Only patients with valid final pharmacokinetic values were analysed||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
819339|NCT01136174|Secondary|Cmax,ss After Multiple Doses of Pirfenidone 600 mg Without BIBF 1120 (After Breakfast)|Maximum measured concentration of the analyte in plasma at steady state was identified from measurements obtained at multiple time points after multiple doses of Pirfenidone 600 mg without BIBF 1120 (after breakfast)|Day -1 at Visit 1: At pre-dose and 0.5 h, 1 h, 2 h, 3 h after morning dose and pre-dose after lunch dose|Treated set-Only patients with valid final pharmacokinetic values were analysed||ng/mL||Geometric Coefficient of Variation|Geometric Mean
819340|NCT01136174|Secondary|AUC0-4,ss After Multiple Doses of Pirfenidone 600 mg Without BIBF 1120 (After Breakfast)|AUC0-4,ss was calculated as the area under the curve of the concentration-time profile of the analyte in plasma at steady state over the time interval from 0 to 4 hours after multiple doses of Pirfenidone 600 mg without BIBF 1120 (after breakfast) in the time frame mentioned.|Day -1 at Visit 1: At pre-dose and 0.5 h, 1 h, 2 h, 3 h after morning dose and pre-dose after lunch dose|Treated set- Only patients with valid final pharmacokinetic values were analysed||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
819341|NCT01136174|Secondary|Cmax,ss After Multiple Doses of BIBF 1120 With Pirfenidone|"Maximum measured concentration of the analyte in plasma at steady state was identified from measurements obtained at multiple time points over a uniform dosing interval τ after multiple doses of BIBF 1120 with pirfenidone
Detailed outcome measure time frame:
In 50 mg and 100 mg dose group:
BIBF 1120:
days 14 (-1, +3) to 17 at Visit 5: At pre-dose and 0.5 h, 1 h, 2 h, 3 h, 3.92 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h after morning dose
In 150 mg dose group:
BIBF 1120:
days 28 (-1, +3) to 31 at Visit 5: At pre-dose and 0.5 h, 1 h, 2 h, 3 h, 3.92 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h after morning dose"|pre-dose, then 0.5 h, 1 h, 2 h, 3 h, 3.92 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h after morning dose on days 14 to 17 (BIBF 1120 50 mg and 100 mg) or on days 28 to 31 (BIBF 1120 150 mg)|Treated set- Only patients with valid final pharmacokinetic values were analysed||ng/mL||Geometric Coefficient of Variation|Geometric Mean
819342|NCT01136174|Secondary|AUCτ,ss After Multiple Doses of BIBF 1120 With Pirfenidone|"AUCτ,ss was calculated as the area under the concentration-time curve of the concentration-time profile of the analyte in plasma at steady state over a uniform dosing interval τ after multiple doses of BIBF 1120 with pirfenidone in the time frame mentioned.
Detailed outcome measure time frame:
In 50 mg and 100 mg dose group:
BIBF 1120:
days 14 (-1, +3) to 17 at Visit 5: At pre-dose and 0.5 h, 1 h, 2 h, 3 h, 3.92 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h after morning dose
In 150 mg dose group:
BIBF 1120:
days 28 (-1, +3) to 31 at Visit 5: At pre-dose and 0.5 h, 1 h, 2 h, 3 h, 3.92 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h after morning dose"|pre-dose, then 0.5 h, 1 h, 2 h, 3 h, 3.92 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h after morning dose on days 14 to 17 (BIBF 1120 50 mg and 100 mg) or on days 28 to 31 (BIBF 1120 150 mg)|Treated set- Only patients with valid final pharmacokinetic values were analysed||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
819343|NCT01136174|Secondary|Cmax,ss After Multiple Doses of BIBF 1120 Without Pirfenidone|"Maximum measured concentration of the analyte in plasma at steady state was identified from measurements obtained at multiple time points over a uniform dosing interval τ after multiple doses of BIBF 1120 without pirfenidone.
Detailed outcome measure time frame:
In 50 mg and 100 mg dose group:
BIBF 1120:
days 14 (-1, +3) to 17 at Visit 5: At pre-dose and 0.5 h, 1 h, 2 h, 3 h, 3.92 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h after morning dose
In 150 mg dose group:
BIBF 1120:
days 28 (-1, +3) to 31 at Visit 5: At pre-dose and 0.5 h, 1 h, 2 h, 3 h, 3.92 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h after morning dose"|pre-dose, then 0.5 h, 1 h, 2 h, 3 h, 3.92 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h after morning dose on days 14 to 17 (BIBF 1120 50 mg and 100 mg) or on days 28 to 31 (BIBF 1120 150 mg)|Treated set- Only patients with valid final pharmacokinetic values were analysed||ng/mL||Geometric Coefficient of Variation|Geometric Mean
819368|NCT01136408|Secondary|Anticoagulation Effects Trough INR (International Normalised Ratio)|The blood coagulation parameter INR was assessed in patients allocated to the dabigatran etexilate groups at week 0, prior to drug administration and at the trough at week 1, 4 and 12.|Week 0,1,4 and 12|Full Analysis Set||ratio||Geometric Coefficient of Variation|Geometric Mean
819369|NCT01136408|Secondary|Anticoagulation Effects Trough ECT (Ecarin Clotting Time)|The blood coagulation parameter ECT was assessed in patients allocated to the dabigatran etexilate groups at week 0, prior to drug administration and at the trough at week 1, 4 and 12.|Week 0,1,4 and 12|Full Analysis Set||seconds||Geometric Coefficient of Variation|Geometric Mean
819703|NCT01130597|Secondary|Mean Patiromer Dose at Week 4||Up to Week 4|||grams||Standard Deviation|Mean
819344|NCT01136174|Secondary|AUCτ,ss After Multiple Doses of BIBF 1120 Without Pirfenidone|"AUCτ,ss was calculated as the area under the concentration-time curve of the concentration-time profile of the analyte in plasma at steady state over a uniform dosing interval τ after multiple doses of BIBF 1120 without pirfenidone in the time frame mentioned.
Detailed outcome measure time frame:
In 50 mg and 100 mg dose group:
BIBF 1120:
days 14 (-1, +3) to 17 at Visit 5: At pre-dose and 0.5 h, 1 h, 2 h, 3 h, 3.92 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h after morning dose
In 150 mg dose group:
BIBF 1120:
days 28 (-1, +3) to 31 at Visit 5: At pre-dose and 0.5 h, 1 h, 2 h, 3 h, 3.92 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h after morning dose"|pre-dose, then 0.5 h, 1 h, 2 h, 3 h, 3.92 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h after morning dose on days 14 to 17 (BIBF 1120 50 mg and 100 mg) or on days 28 to 31 (BIBF 1120 150 mg)|Treated set||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
819345|NCT01136174|Primary|Drug-related Adverse Events|The number of patients with drug-related adverse events stratified according to pirfenidone use in each group|after the first drug intake until 28 days from the last treatment administration, up to 60 days|Treated set||participants|||Number
819346|NCT01136226|Secondary|Safety Assessments|Assess frequency and severity of spontaneously reported AE's Changes between baseline and testosterone recovery in serum testosterone and pre biopsy PSA clinical evidence of Prostate cancer changes between baseline and testosterone recovery in health questionnaire|6 months||||||
819347|NCT01136226|Primary|Serum Testosterone Recovery|To Evaluate the time to testosterone recovery, which is defined as a return to with in 90% of pretreatment level, after 6 months of neo-adjuvant treatment with Eligard 22.5mg with Radiation Therapy in patients with early prostate Cancer|6 mos|||Months||Full Range|Mean
819348|NCT01136291|Secondary|Quality of Life Through World Health Organization Quality of Life Abbreviated Questionnaire WHOQOL-Bref)|All pregnant women responded to the quality of life WHOQOL-bref questionnaire, at study inclusion and at the completion of 36 gestational weeks. The domains of these questionnaires were calculated on a scale of zero (the worse quality of life) to 100 points (the better quality of life).|at the 14 and at the 40 gestational weeks|||scores on a scale||Standard Deviation|Mean
819349|NCT01136291|Primary|Weight Gain During the Program|Weight gain during the program was the difference between the weight measured at study entry and final consultation weight, measured by a mechanical scale, in kilos and grams|at the 14 to 40 gestational weeks|||kg||Standard Deviation|Mean
819350|NCT01136291|Primary|Gestational Weight Gain|Gestational weight gain is the difference between the prepregnancy weight and the last weight measure at the end of pregnancy|baseline and at 40 gestational weeks|||kg||Standard Deviation|Mean
819351|NCT01136356|Secondary|Mean Peak Sleep Assessed by Pittsburgh Sleep Quality Index (PSQI)|Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality, total scores range from 0 (better) to 21(worse). The data that has been reported reflects the peak scores on the PSQI during the withdrawal period from both morphine and buprenorphine.|Average mean peak sleep assessed once a week for up to 8 weeks|||units on a scale||Standard Error|Mean
819352|NCT01136356|Secondary|Mean Daily Peak Pain Ratings Assessed by the Visual Analog Scale (VAS)|"Visual Analog Scale (VAS) measures subjective ratings on pain. The scale on this measurement ranges from 0 being None to 100 being Extremely. The results below reflect the subjective measurements of pain taken from day 0 to day 18 of withdrawal from both morphine and buprenorphine."|Average mean daily peak pain ratings assessed from day 0 to day 18 during the 18 day withdrawal period|||units on a scale||Full Range|Mean
819353|NCT01136356|Primary|Mean Peak Opioid Withdrawal Assessed by the Clinical Opiate Withdrawal Scale (COWS)|Clinical Opiate Withdrawal Scale (COWS) is an observer-rated tool for quantifying opioid withdrawal. The scale ranges from 0 to 48: Scores 5 to 12 are mild, 13 to 24 are moderate, 25 to 36 are moderately severe, and over 36 are severe withdrawal. The scores on this repeated measure were analyzed by a two-factor ANOVA for mean peak daily COWS ratings.|Average mean peak opioid withdrawal thirty minutes before and after injection assessed up to 59 days|||units on a scale||Full Range|Mean
819354|NCT01136382|Secondary|Number of Withdrawals Due to Pre-defined Asthma Events|Patients were considered to have experienced a “pre-defined asthma event” if any of the following conditions were met during the study: 1. At each visit or follow-up visit, a decrease in morning pre-dose FEV1 >=20% from the Visit 3 (randomization visit) morning pre-dose FEV1 or a decrease to <65% of predicted normal value; 2. The use of >=8 actuations of albuterol/salbutamol per day on 3 or more days within any period of 7 consecutive days following randomization; 3. A decrease in morning PEF >=20% from baseline on 3 or more days within any period of 7 consecutive days after randomization; 4. Two or more nights with an awakening due to asthma, which required the use of reliever medication within any period of 7 consecutive days after randomization; 5. A clinical exacerbation requiring emergency treatment, hospitalization, or use of an asthma medication not allowed by the study protocol.|Baseline to 6 weeks|The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint.||participants|||Number
819355|NCT01136382|Secondary|Change in Nighttime Reliever Medication Use From Baseline to Treatment Period Average|The patient, with the help of their caregiver, recorded the number of inhalations of reliever medication used, for relief of asthma symptoms, twice daily in the eDiary. Patients were asked to respond to a standard question twice daily (morning and evening). The question to be answered was, “How many albuterol/salbutamol inhalations since last diary entry?”|Baseline to 6 weeks|The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint.||inhalations per day||Standard Error|Least Squares Mean
819356|NCT01136382|Secondary|Change in Total Daily and Daytime Reliever Medication Use From Baseline to Treatment Period Average|The patient, with the help of their caregiver, recorded the number of inhalations of reliever medication used, for relief of asthma symptoms, twice daily in the eDiary. Patients were asked to respond to a standard question twice daily (morning and evening). The question to be answered was, “How many albuterol/salbutamol inhalations since last diary entry?”|Baseline to 6 weeks|The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint.||inhalations per day||Standard Error|Least Squares Mean
819370|NCT01136408|Secondary|Anticoagulation Effects Trough aPTT (Activated Partial Thromboplastin Time)|The blood coagulation parameter aPTT was assessed in patients allocated to the dabigatran etexilate groups at week 0, prior to drug administration and at the trough at week 1, 4 and 12.|Week 0,1,4 and 12|Full Analysis Set||seconds||Geometric Coefficient of Variation|Geometric Mean
819357|NCT01136382|Secondary|Change in Nighttime Awakenings and Nighttime Awakenings With Reliever Medication Use From Baseline to Treatment Period Average|Patients, with the help of their caregiver, were asked to respond to a standard question each morning as they completed their eDiary. The question to be answered was, “Did your asthma cause you to wake-up last night?” If yes, patients were asked, “Did you need to use your reliever medication (albuterol/salbutamol inhaler) before you went back to sleep?” Baseline is defined as the percentage of days where patient experienced nighttime awakenings out of all available days where data was collected during the last 7 days of the run-in period.|Baseline to 6 weeks|The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint.||percentage of days with awakenings||Standard Error|Least Squares Mean
819358|NCT01136382|Secondary|Change in Nighttime Asthma Symptom Score From Baseline to Treatment Period Average|Patients, with the help of their caregiver, were required to rate and document their asthma symptoms twice daily as an overall symptom score for the time period since their previous recording. The following rating scales were used: 0 = None; no symptoms of asthma; 1 = Mild symptoms; awareness of asthma symptoms and/or signs that are easily tolerated; 2 = Moderate symptoms, asthma symptoms with some discomfort, causing some interference with daily activities or sleep; 3 = Severe symptoms; incapacitating asthma symptoms and/or signs, with inability to perform daily activities or to sleep.|Baseline to 6 weeks|The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint.||units on a scale||Standard Error|Least Squares Mean
819359|NCT01136382|Secondary|Change in Total Daily and Daytime Asthma Symptom Scores From Baseline to Treatment Period Average|Patients, with the help of their caregiver, were required to rate and document their asthma symptoms twice daily as an overall symptom score for the time period since their previous recording. The following rating scales were used: 0 = None; no symptoms of asthma; 1 = Mild symptoms; awareness of asthma symptoms and/or signs that are easily tolerated; 2 = Moderate symptoms, asthma symptoms with some discomfort, causing some interference with daily activities or sleep; 3 = Severe symptoms; incapacitating asthma symptoms and/or signs, with inability to perform daily activities or to sleep.|Baseline to 6 weeks|The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint.||units on a scale||Standard Error|Least Squares Mean
819360|NCT01136382|Secondary|Change in Forced Mid-expiratory Flow Between 25% and 75% of the FVC (FEF25-75) From Baseline to Treatment Period Average|FEF25-75 is the average rate of airflow during the midportion of the forced vital capacity. Baseline was defined as the pre-dose assessment value measured at randomization (Visit 3), and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period.|Baseline to 6 weeks|The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint.||liters/second||Standard Error|Least Squares Mean
819361|NCT01136382|Secondary|Change in Forced Vital Capacity (FVC) From Baseline to Treatment Period Average|FVC is the total volume of air expired after a full inspiration. Baseline was defined as the pre-dose assessment value measured at randomization (Visit 3), and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period.|Baseline to 6 weeks|The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint.||liters||Standard Error|Least Squares Mean
819362|NCT01136382|Secondary|Change in Evening PEF From Baseline to the Treatment Period Average|The peak expiratory flow rate is the maximal rate that a person can exhale during a short maximal expiratory effort after a full inspiration. Baseline was calculated using the mean of the data recorded during the last 7 days of the run-in period, and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period.|Baseline to 6 weeks|The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint.||liters/minute||Standard Error|Least Squares Mean
819363|NCT01136382|Secondary|Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to Treatment Period Average|FEV1 is the volume exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity. Baseline was defined as the pre-dose assessment value measured at randomization (Visit 3), and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period.|Baseline to 6 weeks|The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint.||liters||Standard Error|Least Squares Mean
819364|NCT01136382|Primary|Change in Morning Peak Expiratory Flow (PEF) From Baseline to the Treatment Period Average|The peak expiratory flow rate is the maximal rate that a person can exhale during a short maximal expiratory effort after a full inspiration. Baseline was calculated using the mean of the data recorded during the last 7 days of the run-in period, and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period.|Baseline to 6 weeks|The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint.||liters/minute||Standard Error|Least Squares Mean
819365|NCT01136408|Primary|Changes in Laboratory Test Values|The number of patients with ALT, AST, alkaline phosphatase, or bilirubin exceeded the upper limit of normal (ULN) range|12 weeks|Safety set was used for safety endpoints. Full analysis set was used for efficacy endpoints. The safety set comprises all patients who were treated with trial medication at least once. The full analysis set comprises all patients who were randomised and treated with trial medication at least once. No data was imputed.||participants|||Number
819366|NCT01136408|Secondary|Steady-state Pharmacokinetics of Total Dabigatran Trough Plasma Concentration||Week 1,4 and 12|Full Analysis Set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
819367|NCT01136408|Secondary|Anticoagulation Effects Trough 11-dehydrothromboxane B2|Analysis based on concomitant use of aspirin compared to no aspirin users. 11-dehydrothromboxane B2 is measured in urine of patients.|Week 0 and 12|Per Protocol Analysis Set||pg/mg creatinine||Geometric Coefficient of Variation|Geometric Mean
819704|NCT01130597|Secondary|Mean Patiromer Dose at Week 1||Up to Week 1|||grams||Standard Deviation|Mean
819705|NCT01130597|Secondary|Mean Number of Patiromer Titrations||56 Days|||patiromer titrations||Standard Deviation|Mean
819371|NCT01136408|Primary|Discontinuation of the Study Drug Due to Adverse Events|Discontinuation of the study drug due to adverse events.|Upto 15 weeks|Safety set was used for safety endpoints. Full analysis set was used for efficacy endpoints. The safety set comprises all patients who were treated with trial medication at least once. The full analysis set comprises all patients who were randomised and treated with trial medication at least once. No data was imputed.||participants|||Number
819372|NCT01136408|Primary|Incidence and Severity of Adverse Events|Intensity of event is categorised as mild, moderate and severe.|Upto 15 weeks|Safety set was used for safety endpoints. Full analysis set was used for efficacy endpoints. The safety set comprises all patients who were treated with trial medication at least once. The full analysis set comprises all patients who were randomised and treated with trial medication at least once. No data was imputed.||participants|||Number
819373|NCT01136408|Secondary|Frequency (Occurrence Rates) of Death|The percentage of patients with death|Upto 15 weeks|Safety set was used for safety endpoints. Full analysis set was used for efficacy endpoints. The safety set comprises all patients who were treated with trial medication at least once. The full analysis set comprises all patients who were randomised and treated with trial medication at least once. No data was imputed.||Percentage of patients|||Number
819374|NCT01136408|Secondary|Frequency (Occurrence Rates) of Other Major Adverse Cardiac Events|The percentage of patients with other major adverse cardiac events|Upto 15 weeks|Safety set was used for safety endpoints. Full analysis set was used for efficacy endpoints. The safety set comprises all patients who were treated with trial medication at least once. The full analysis set comprises all patients who were randomised and treated with trial medication at least once. No data was imputed.||Percentage of patients|||Number
819375|NCT01136408|Secondary|Frequency (Occurrence Rates) of Myocardial Infarction (Fatal or Non-fatal)|The percentage of patients with myocardial infarction (fatal or non-fatal)|Upto 15 weeks|Safety set was used for safety endpoints. Full analysis set was used for efficacy endpoints. The safety set comprises all patients who were treated with trial medication at least once. The full analysis set comprises all patients who were randomised and treated with trial medication at least once. No data was imputed.||Percentage of patients|||Number
819376|NCT01136408|Secondary|Frequency (Occurrence Rates) of Systemic Embolism|The percentage of patients with systemic embolism|Upto 15 weeks|Safety set was used for safety endpoints. Full analysis set was used for efficacy endpoints. The safety set comprises all patients who were treated with trial medication at least once. The full analysis set comprises all patients who were randomised and treated with trial medication at least once. No data was imputed.||Percentage of patients|||Number
819377|NCT01136408|Secondary|Frequency (Occurrence Rates) of Transient Ischemic Attack|The percentage of patients with transient ischemic attack|Upto 15 weeks|Safety set was used for safety endpoints. Full analysis set was used for efficacy endpoints. The safety set comprises all patients who were treated with trial medication at least once. The full analysis set comprises all patients who were randomised and treated with trial medication at least once. No data was imputed.||Percentage of patients|||Number
819378|NCT01136408|Secondary|Frequency (Occurrence Rates) of Ischemic or Haemorrhagic Stroke (Fatal or Non-fatal)|The percentage of patients with ischemic or haemorrhagic stroke (fatal or non-fatal)|Upto 15 weeks|Safety set was used for safety endpoints. Full analysis set was used for efficacy endpoints. The safety set comprises all patients who were treated with trial medication at least once. The full analysis set comprises all patients who were randomised and treated with trial medication at least once. No data was imputed.||Percentage of patients|||Number
819379|NCT01136408|Secondary|Frequency (Occurrence Rates) of a Composite Clinical Endpoint.|Percentage of patients with the composite clinical endpoint (ischemic or haemorrhagic stroke (fatal or non-fatal), transient ischemic attacks, systemic embolism, myocardial infarction (fatal or non-fatal), other major adverse cardiac events, and death)|Upto 15 weeks|Safety set was used for safety endpoints. Full analysis set was used for efficacy endpoints. The safety set comprises all patients who were treated with trial medication at least once. The full analysis set comprises all patients who were randomised and treated with trial medication at least once. No data was imputed.||Percentage of patients|||Number
819380|NCT01136408|Primary|Frequency (Occurrence Rates) of Nuisance Bleeding Event|"The percentage of patients with nuisance bleeding event
Any bleed that did not qualify as a major bleed was defined as a minor bleed; all minor bleeding events not fulfilling one of the criteria below was defined as a nuisance bleeding event:
A skin haematoma of at least 25 sqcm
Spontaneous nose bleed lasting for more than 5 minutes
Macroscopic haematuria (either spontaneous or, if associated with an intervention, lasting more than 24 hours)
Spontaneous rectal bleeding (more than spotting on toilet paper)
Gingival bleeding lasting for more than 5 minutes
Bleeding leading to hospitalisation
Bleeding leading to blood transfusion (erythrocyte component transfusion or whole blood transfusion) of less than 4.5 units (equal to 2 units in EU/US)
Any other bleeding considered clinically relevant by the investigator"|Upto 15 weeks|Safety set was used for safety endpoints. Full analysis set was used for efficacy endpoints. The safety set comprises all patients who were treated with trial medication at least once. The full analysis set comprises all patients who were randomised and treated with trial medication at least once. No data was imputed.||Percentage of patients|||Number
819381|NCT01136408|Primary|Frequency (Occurrence Rates) of Clinically Relevant Bleeding Event|"The percentage of patients with clinically relevant bleeding event.
Any bleed that did not qualify as a major bleed was defined as a minor bleed; minor bleed which fulfilled one of the criteria below was defined as a clinically relevant bleeding event:
A skin haematoma of at least 25 sqcm
Spontaneous nose bleed lasting for more than 5 minutes
Macroscopic haematuria (either spontaneous or, if associated with an intervention, lasting more than 24 hours)
Spontaneous rectal bleeding (more than spotting on toilet paper)
Gingival bleeding lasting for more than 5 minutes
Bleeding leading to hospitalisation
Bleeding leading to blood transfusion (erythrocyte component transfusion or whole blood transfusion) of less than 4.5 units (equal to 2 units in EU/US)
Any other bleeding considered clinically relevant by the investigator"|upto 15 weeks|Safety set was used for safety endpoints. Full analysis set was used for efficacy endpoints. The safety set comprises all patients who were treated with trial medication at least once. The full analysis set comprises all patients who were randomised and treated with trial medication at least once. No data was imputed.||Percentage of patients|||Number
819410|NCT01136746|Secondary|Percentage of Participants Achieving MPG Within Range 71 to 179 mg/dL and Within the Target of 100 to 179 mg/dL by Hospital Day|Due to low enrollment, this outcome measure was not analyzed.|Day 1 up to day 10 of hospital study period|Due to low enrollment, zero participants were analyzed.|||||
819382|NCT01136408|Primary|Frequency (Occurrence Rates) of Major Bleeding Event|"The percentage of patients with major bleeding event.
Major bleeding was defined as any bleed fulfilling one of the following conditions:
Fatal or life-threatening
Retroperitoneal, intracranial, intraocular, or intraspinal bleeding (verified by objective testing)
Bleeding requiring surgical treatment
Clinically overt bleeding leading to a transfusion (erythrocyte component transfusion or whole blood transfusion) of 4.5 units (equal to 2 units in EU/US) or more
Clinically overt bleeding leading to a fall in haemoglobin of at least 2 g/dL"|upto 15 weeks|Safety set was used for safety endpoints. Full analysis set was used for efficacy endpoints. The safety set comprises all patients who were treated with trial medication at least once. The full analysis set comprises all patients who were randomised and treated with trial medication at least once. No data was imputed.||Percentage of patients|||Number
819383|NCT01136486|Primary|Assessment of Pain Severity|Pain was assessed on a scale for 1 (no pain) to 10 (severe) pain. This is observational study so participants were only seen at one time point, when they were referred to the neuropsychology service.|Referral|||units on a scale||Standard Deviation|Mean
819384|NCT01136655|Secondary|Urinary Excretion of Formoterol During the 12 Hours Following Inhalation of Study Drug|The amount of formoterol excreted unchanged in urine over the 12-hour period after administration [Ae(0-12h)] was calculated from the concentration of formoterol in urine multiplied by the total volume of urine collected. Volume was determined from the weight of the collected urine times an assumed urine density of 1020 g/L. The data for six patients who did not have measurable formoterol in their urine on the Foradil 12 μg treatment day was excluded from the analysis. All other urine concentrations below the lower limit of quantification were set to zero. One subject was incorrectly administered BUD 160/ formoterol (FM) 9.0 rather than BUD 160/ Foradil 12.0 at Period 4. Hence this subject is included in the Efficacy Analysis Set, but not the Safety Analysis Set for BUD 160/ Foradil 12.0.|0 to 12 hours|Efficacy analysis set including all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.||pmol||95% Confidence Interval|Least Squares Mean
819385|NCT01136655|Secondary|Maximal FEV1 During the 12-hour Study Period|Pulmonary function tests consisted of 3 forced expiratory maneuvers in which the patient expired forcefully from total lung capacity to residual volume, recorded using a spirometer. FEV1 was measured at 3, 9, 15, 60, 120, 180, 240, 360, 480, 600 and 720 minutes post administration of randomized study medication. The maximum FEV1 value was defined as the largest observed FEV1 value recorded during each 12-hour serial spirometry procedure. One subject was incorrectly administered BUD 160/ formoterol (FM) 9.0 rather than BUD 160/ Foradil 12.0 at Period 4. Hence this subject is included in the Efficacy Analysis Set, but not the Safety Analysis Set for BUD 160/ Foradil 12.0.|at 3, 9, 15, 60, 120, 180, 240, 360, 480, 600 and 720 minutes postdose|Efficacy analysis set including all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.||liters||Standard Error|Least Squares Mean
819386|NCT01136655|Secondary|FEV1 at 12 Hours After Study Medication Inhalation|Pulmonary function tests consisted of 3 forced expiratory maneuvers in which the patient expired forcefully from total lung capacity to residual volume, recorded using a spirometer. The FEV1 value at 12 hours after dosing was taken as the 12-hour measurement (720 minutes) from the serial spirometry. One subject was incorrectly administered BUD 160/ formoterol (FM) 9.0 rather than BUD 160/ Foradil 12.0 at Period 4. Hence this subject is included in the Efficacy Analysis Set, but not the Safety Analysis Set for BUD 160/ Foradil 12.0.|12 hours after dosing|Efficacy analysis set including all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.||liters||Standard Error|Least Squares Mean
819387|NCT01136655|Primary|Average 12 Hour Forced Expiratory Volume in 1 Second (FEV1)|Pulmonary function tests consisted of 3 forced expiratory maneuvers in which the patient expired forcefully from total lung capacity to residual volume, recorded using a spirometer. FEV1 was obtained from the full expiratory flow-volume-time curve. FEV1 was measured at 3, 9, 15, 60, 120, 180, 240, 360, 480, 600 and 720 minutes post administration of randomized study medication. Twelve-hour serial FEV1 was calculated through an AUC determination and then divided by time, so that the final value is expressed in liters. One subject was incorrectly administered BUD 160/ formoterol (FM) 9.0 rather than BUD 160/ Foradil 12.0 at Period 4. Hence this subject is included in the Efficacy Analysis Set, but not the Safety Analysis Set for BUD 160/ Foradil 12.0.|at 3, 9, 15, 60, 120, 180, 240, 360, 480, 600 and 720 minutes postdose|Efficacy analysis set including all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.||liters||Standard Error|Least Squares Mean
819388|NCT01136746|Secondary|Number of Participants With Major Adverse Cardiovascular Events (MACE)|MACE was defined as the composite of all-cause death, nonfatal myocardial infarction (MI), or nonfatal stroke. Due to low enrollment, this outcome measure was not analyzed.|Throughout hospital study period (1 to 10 days post-randomization)|Due to low enrollment, zero participants were analyzed.|||||
819389|NCT01136746|Secondary|Percentage of Participants With Documented Nosocomial Infections|Due to low enrollment, this outcome measure was not analyzed.|Throughout hospital study period (1 to 10 days post-randomization)|Due to low enrollment, zero participants were analyzed.|||||
819390|NCT01136746|Secondary|Percentage of Participants With Deterioration of Renal Function Throughout the Hospital Study Period|Deterioration of renal function was defined by an increase in serum creatinine by >0.5 milligrams per deciliter (mg/dL). Due to low enrollment, this outcome measure was not analyzed.|Throughout hospital study period (1 to 10 days post-randomization)|Due to low enrollment, zero participants were analyzed.|||||
819391|NCT01136746|Secondary|Percentage of Participants Requiring Intensive Care Unit Transfer|Due to low enrollment, this outcome measure was not analyzed.|Throughout hospital study period (1 to 10 days post-randomization)|Due to low enrollment, zero participants were analyzed.|||||
819411|NCT01136746|Secondary|Percentage of Participants Achieving MPG Within Range 71 to 179 mg/dL and Within the Target of 100 to 179 mg/dL Throughout Hospital Study Period|Due to low enrollment, this outcome measure was not analyzed.|Throughout hospital study period (1 to 10 days post-randomization)|Due to low enrollment, zero participants were analyzed.|||||
819392|NCT01136746|Secondary|Number of Participants With Treatment-emergent Adverse Events Throughout Hospital Study Period|Treatment-emergent adverse event – any untoward medical occurrence that either occurred or worsened at any time after treatment baseline and which did not necessarily have a causal relationship with this treatment. A summary of adverse events is located in the Reported Adverse Event Module.|Throughout hospital study period (1 to 10 days post-randomization)|All randomized participants||participants|||Number
819393|NCT01136746|Secondary|Number of Hypoglycemia and Severe Hypoglycemia Episodes Adjusted for 30 Days (Rate), by Hospital Day|Hypoglycemia was defined as any time a recorded capillary PG level is ≤70 mg/dL, even if it is not associated with signs or symptoms, or treatment consistent with current guidelines (ADA 2005; ADA 2010). Severe hypoglycemia was defined as an episode associated with a recorded capillary (or venous) PG <40 mg/dL, even if it is not associated with need for assistance or neuroglycopenic symptoms (ADA 2005) or prompt recovery after oral carbohydrate, glucagon, or IV glucose. Due to low enrollment, this outcome measure was not analyzed.|Day 1 up to day 10 of hospital study period|Due to low enrollment, zero participants were analyzed.|||||
819394|NCT01136746|Secondary|Number (Incidence) of Hypoglycemia and Severe Hypoglycemia Episodes, by Hospital Day|Hypoglycemia was defined as any time a recorded capillary PG level is ≤70 mg/dL, even if it is not associated with signs or symptoms, or treatment consistent with current guidelines (ADA 2005; ADA 2010). Severe hypoglycemia was defined as an episode associated with a recorded capillary (or venous) PG <40 mg/dL, even if it is not associated with need for assistance or neuroglycopenic symptoms (ADA 2005) or prompt recovery after oral carbohydrate, glucagon, or IV glucose. Due to low enrollment, this outcome measure was not analyzed.|Day 1 up to day 10 of hospital study period|Due to low enrollment, zero participants were analyzed.|||||
819395|NCT01136746|Secondary|Number of Hypoglycemia and Severe Hypoglycemia Episodes Adjusted for 30 Days (Rate), Throughout Hospital Study Period|Hypoglycemia was defined as any time a recorded capillary PG level is ≤70 mg/dL, even if it is not associated with signs or symptoms, or treatment consistent with current guidelines (ADA 2005; ADA 2010). Severe hypoglycemia was defined as an episode associated with a recorded capillary (or venous) PG <40 mg/dL, even if it is not associated with need for assistance or neuroglycopenic symptoms (ADA 2005) or prompt recovery after oral carbohydrate, glucagon, or IV glucose. Due to low enrollment, this outcome measure was not analyzed.|Throughout hospital study period (1 to 10 days post-randomization)|Due to low enrollment, zero participants were analyzed.|||||
819396|NCT01136746|Secondary|Number (Incidence) of Hypoglycemia and Severe Hypoglycemia Episodes, Throughout Hospital Study Period|Hypoglycemia was defined as any time a recorded capillary PG level is ≤70 mg/dL, even if it is not associated with signs or symptoms, or treatment consistent with current guidelines (ADA 2005; ADA 2010). Severe hypoglycemia was defined as an episode associated with a recorded capillary (or venous) PG <40 mg/dL (Umpierrez et al. 2007; Moghissi et al. 2009; Umpierrez et al. 2009), even if it is not associated with need for assistance or neuroglycopenic symptoms (ADA 2005) or prompt recovery after oral carbohydrate, glucagon, or IV glucose.|Throughout hospital study period (1 to 10 days post-randomization)|All randomized participants who had at least one post-baseline glucose measurement.||hypoglycemic episodes|||Number
819397|NCT01136746|Secondary|Length of Hospital Stay Post-randomization Throughout the Hospital Study Period|Due to low enrollment, this outcome measure was not analyzed.|Throughout the hospital study period (1 to 10 days post-randomization)|Due to low enrollment, zero participants were analyzed.|||||
819398|NCT01136746|Secondary|TDD of Insulin (Units/kg) by Hospital Day|Due to low enrollment, this outcome measure was not analyzed.|Day 1 up to day 10 of hospital study period|Due to low enrollment, zero participants were analyzed.|||||
819399|NCT01136746|Secondary|TDD of Insulin (Units) by Hospital Day|Due to low enrollment, this outcome measure was not analyzed.|Day 1 up to day 10 of hospital study period|Due to low enrollment, zero participants were analyzed.|||||
819400|NCT01136746|Secondary|TDD of Insulin (Units/kg) Throughout the Hospital Study Period|Due to low enrollment, this outcome measure was not analyzed.|Throughout the hospital study period (1 to 10 days post-randomization)|Due to low enrollment, zero participants were analyzed.|||||
819401|NCT01136746|Secondary|Total Daily Dose (TDD) of Insulin (Units) Throughout the Hospital Study Period|Due to low enrollment, this outcome measure was not analyzed.|Throughout the hospital study period (1 to 10 days post-randomization)|Due to low enrollment, zero participants were analyzed.|||||
819402|NCT01136746|Secondary|Percentage of Capillary PG Measurements >240 mg/dL by Hospital Day|Due to low enrollment, this outcome measure was not analyzed.|Day 1 up to day 10 of hospital study period|Due to low enrollment, zero participants were analyzed.|||||
819403|NCT01136746|Secondary|Percentage of Capillary PG Measurements >240 mg/dL Throughout the Hospital Study Period|Due to low enrollment, this outcome measure was not analyzed.|Throughout the hospital study period (1 to 10 days post-randomization)|Due to low enrollment, zero participants were analyzed.|||||
819404|NCT01136746|Secondary|Percentage of Participants Achieving Mean FPG Range of 71 to 139 mg/dL and Target of 100 to 139 mg/dL by Hospital Day|Due to low enrollment, this outcome measure was not analyzed.|Day 1 up to day 10 of hospital study period|Due to low enrollment, zero participants were analyzed.|||||
819405|NCT01136746|Secondary|Percentage of Participants Achieving Mean FPG Range of 71 to 139 mg/dL and Target of 100 to 139 mg/dL Throughout the Hospital Study Period|Due to low enrollment, this outcome measure was not analyzed.|Throughout the hospital study period (1 to 10 days post-randomization)|Due to low enrollment, zero participants were analyzed.|||||
819406|NCT01136746|Secondary|Percentage of Fasting Capillary PG Measurements Within the Range of 71 to 139 mg/dL and Within the Target of 100 to 139 mg/dL by Hospital Day|Due to low enrollment, this outcome measure was not analyzed.|Day 1 up to day 10 of hospital study period|Due to low enrollment, zero participants were analyzed.|||||
819407|NCT01136746|Secondary|Percentage of Fasting Capillary PG Measurements Within the Range of 71 to 139 mg/dL and Within the Target of 100 to 139 mg/dL Throughout the Hospital Study Period|Due to low enrollment, this outcome measure was not analyzed.|Throughout the hospital study period (1 to 10 days post-randomization)|Due to low enrollment, zero participants were analyzed.|||||
819408|NCT01136746|Secondary|Mean FPG Throughout Hospital Study Period|Due to low enrollment, this outcome measure was not analyzed.|Throughout hospital study period (1 to 10 days post-randomization)|Due to low enrollment, zero participants were analyzed.|||||
819409|NCT01136746|Secondary|Mean Fasting Plasma Glucose (FPG) by Hospital Day|Due to low enrollment, this outcome measure was not analyzed.|Day 1 up to day 10 of hospital study period|Due to low enrollment, zero participants were analyzed.|||||
819413|NCT01136746|Secondary|Mean Plasma Glucose (MPG) by Hospital Day|The intent was to report results up to Day 10; however, due to low enrollment, mean and standard deviations are only reported up to Day 7.|Day 1 up to day 7 of hospital study period|All randomized participants who had at least one post-baseline glucose measurement and a plasma glucose measurement at specified timepoint.||mg/dL||Standard Deviation|Mean
819414|NCT01136746|Primary|Percentage of Capillary Plasma Glucose Measurements Within the Range of 71 to 179 mg/dL Throughout the Hospital Study Period|Results are reported as the percentage of total number of capillary plasma glucose measurements within the range of 71 to 179 mg/dL for each treatment arm.|Throughout hospital study period (1 to 10 days post-randomization)|All randomized participants who had at least one post-baseline glucose measurement.||percentage of capillary PG measurements|Participants||Number
819415|NCT01136746|Primary|Mean Plasma Glucose (MPG) Throughout Hospital Study Period|Overall MPG is derived as the mean of plasma glucose (PG) readings from Day/Visit 1 to Day/Visit 10.|Throughout hospital study period (1 to 10 days post-randomization)|All randomized participants who had at least one post-baseline glucose measurement.||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
819416|NCT01136772|Secondary|Changes in Psychiatric Symptoms|The Positive and Negative Syndrome Scale measures the core symptoms associated with schizophrenia. The measure includes 30 items rated from 1=absent to 7=extremely severe. Full range of scores is 30-210 with higher scores representing more severe illness. Reductions in symptoms over time represent improvement.|Baseline to 6 months|Participants with PANSS scores at 6 months||Units on a scale||95% Confidence Interval|Mean
819417|NCT01136772|Primary|Efficacy Failure|Efficacy failure as indicated by psychiatric hospitalization, need for crisis intervention, clinical decision that oral antipsychotic medication cannot be discontinued in less than eight weeks, a clinical decision to discontinue the medication due to inadequate benefit, or the ongoing or repeated need for adjunctive antipsychotic medication.|24 months|All randomized participants who received an injection and attended one follow-up appointment||participants|||Number
819418|NCT01136785|Secondary|Change in 24-h Mean Level of Plasma Norepinephrine|The mean plasma norepinephrine level will be calculated for all samples collected at baseline and for all samples collected at the end of the intervention in participants randomized to the active CPAP arm. The goal of the analysis of cortisol, growth hormone and norepinephrine levels was to explore putative mechanisms underlying the effects of active CPAP therapy. Examining putative hormonal mechanisms underlying changes in glucose levels in the sham CPAP arm was not part of our aims. For each participant, the change in mean norepinephine level from baseline to end of intervention will be calculated.|after 1 week of active CPAP therapy in the laboratory|||pg/ml||95% Confidence Interval|Mean
819419|NCT01136785|Secondary|24-hr Profile of Plasma Growth Hormone|The mean plasma growth hormone level will be calculated for all samples collected at baseline and for all samples collected at the end of the intervention in participants randomized to the active CPAP arm. The goal of the analysis of cortisol, growth hormone and norepinephrine levels was to explore putative mechanisms underlying the effects of active CPAP therapy. Examining putative hormonal mechanisms underlying changes in glucose levels in the sham CPAP arm was not part of our aims. For each participant, the change in mean cortisol level from baseline to end of intervention will be calculated.|after 1 week of active CPAP therapy in the laboratory|||ng/ml||95% Confidence Interval|Mean
819420|NCT01136785|Secondary|Change in Mean Plasma Cortisol Level From 24-h Sampling|The mean plasma cortisol level will be calculated for all samples collected at baseline and for all samples collected at the end of the intervention in participants randomized to the active CPAP arm. The goal of the analysis of cortisol, growth hormone and norepinephrine levels was to explore putative mechanisms underlying the effects of active CPAP therapy. Examining putative hormonal mechanisms underlying changes in glucose levels in the sham CPAP arm was not part of our aims. For each participant, the change in mean cortisol level from baseline to end of intervention will be calculated.|after 1 week of active CPAP therapy in the laboratory|||microgram/dL||95% Confidence Interval|Mean
819421|NCT01136785|Primary|Change in Mean Serum Insulin Derived From 24 Hour Blood Sampling|Serum insulin levels will be measured on each sample collected during 24-h sampling at baseline and at the end of the 7-day intervention. Mean insulin level over 24 hours will be calculated for each participant at baseline and at the end of the intervention. For each participant, we will calculate the change in mean insulin level from baseline.|after 1 week of therapy in the laboratory|||pmol/L||Standard Error|Mean
819422|NCT01136785|Primary|Change From Baseline in Mean Glucose From Continuous Interstitial Glucose Monitoring Over 36-40 Hours|Continuous Glucose monitoring will provide interstitial glucose levels for 36-40 hours at baseline and after one week of active or sham CPAP therapy. The mean glucose level of all samples collected at baseline will be calculated for each participant. The mean glucose level of all samples collected at the end of the 7-day intervention will be calculated for each participant. For each participant, we will calculate the change in mean glucose level from baseline till end of the intervention.|change in mean interstitial glucose after 1 week of active or sham CPAP therapy in the laboratory|Due to sensor failures, valid profiles of interstitial glucose were available in 10 participants with the active CPAP group and 4 participants in the sham CPAP group.||mg/dL||Standard Error|Mean
819423|NCT01136785|Primary|Change From Baseline to End of 7-day Intervention in Mean Plasma Glucose Derived From 24 Hour Blood Sampling|24 hour blood sampling will be performed at baseline and at the end of the 7-day intervention. Glucose levels will be measured on each sample. Mean glucose level for all baseline samples will be calculated for each participant. Mean glucose levels for all samples collected at the end of the intervention will be calculated. Change in mean glucose level from baseline to end of intervention will be calculated for each participant.|after 1 week of CPAP therapy in the laboratory|||mg/dl||Standard Error|Mean
819424|NCT01136876|Primary|Impact on the Trajectory of Serum and Urinary NGAL Following the Administration of Non-ionic Low Osmolar Contrast Media in Comparison to a Non-ionic, Iso-osmolar Contrast Media|Mean change from baseline values for serum NGAL at 2,4,6,24,48, and 72 hours, and urine NGAL at 2,4,6,24, and 48 hours following the administration of contrast media.|Baseline and 2, 4, 6, 24, 48,and 72 hours post-dose|||ng/mL||Standard Deviation|Mean
819425|NCT01136915|Primary|Impact on the Trajectory of Serum and Urinary NGAL Following the Administration of Non-ionic, Low-osmolar Contrast Media in Comparison to a Non-ionic, Iso-osmolar Contrast Media.|Mean change from baseline values for serum NGAL at 2,4,6,24,48, and 72 hours, and urine NGAL at 2,4,6,24, and 48 hours following the administration of contrast media.|Baseline and 2,4,6,24, 48, and 72 hours post-dose|||ng/mL||Standard Deviation|Mean
819426|NCT01136954|Secondary|Median Percent Change From Study 312 Baseline in the 28-day Seizure Frequency During the Open Label Period|Participants' parent or guardian maintained a seizure diary recording the date, number, and type of seizures the subject had. Seizure frequency of simple partial, complex partial, and partial seizures with secondary generalization were assessed from baseline of study 312 through the Open Label Visit Period. Percentage change = 100% x (seizure frequency at period - seizure frequency at Study 312 baseline)/seizure frequency at Study 312 baseline.|Baseline of study 312 (Week -8 to Week 0) to Week 59 of study 313|Safety Population||Percentage Change||Full Range|Median
819427|NCT01136954|Secondary|Median Change From Study 312 Baseline in the 28-day Seizure Frequency During the Open Label Period|Participants' parent or guardian maintained a seizure diary recording the date, number, and type of seizures the subject had. Seizure frequency of simple partial, complex partial, and partial seizures with secondary generalization were assessed from baseline of study 312 through the Open Label Visit Period.|Baseline of study 312 (Week -8 to Week 0) to Week 59 of study 313|Safety Population||Seizures||Full Range|Median
819428|NCT01136954|Secondary|Percentage of Participants With a Decrease From Baseline in 28-day Seizure Frequency of =50%(Responder) in the Open Label Period|A participant with a decrease from baseline in seizure frequency of =50 % was considered a responder. Participants'parent or guardian maintained a seizure diary recording the date,number, and type of seizures the subject had. The primary analysis assessed the percent of responders from baseline in the Open Label Visit Period. Seizure frequency of simple partial, complex partial, and partial seizures with secondary generalization were assessed.|Baseline through Week 59|Safety Population||Percentage of Participants|||Number
819429|NCT01136954|Primary|Treatment Emergent Non-Serious Adverse Events With Greater Than 5% Frequency|Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event with a start date on or after Day 1 and within 15 days of last dose. For each event, each participant experiencing an event is only counted once even if they had multiple episodes.|Week 1 through Week 59|Safety Population (all subjects who entered the study and received at least one dose of study drug)||Participants|||Number
819430|NCT01136967|Secondary|Pharmacokinetics and Pharmacodynamics|Due to the sparse PK sampling in this study, the data were pooled with data from other Phase 1 studies conducted in participants with solid tumors.|Predose and 2 to 12 hours postdose at Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1||||||
819431|NCT01136967|Secondary|Number of Participants With Adverse Events (AEs)/ Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Lenvatinib|Safety was assessed by monitoring and recording all AEs including all Common Terminology Criteria for Adverse Events (CTCAE) grades and SAEs; regular monitoring of hematology, clinical chemistry, and urine values; physical examinations; and regular measurement of vital signs, electrocardiograms (ECGs), and multi-gated acquisition (MUGA) scans or echocardiogram.|For each participant, from the first patient first dose till 30 days after the last dose of study drug, up to approximately 2.9 years|Safety Analysis Set included those participants who received at least 1 dose of study drug and had at least 1 post baseline safety evaluation.||Participants|||Number
819432|NCT01136967|Secondary|Clinical Benefit Rate (CBR)|CBR was defined as the percentage of participants who had a BOR of CR or PR or durable SD (SD lasting greater than or equal to 23 weeks) based on IRR and Investigator's assessment. CBR = CR + PR + durable SD rate|From date of first dose of study drug until documentation of disease progression or death from any cause (whichever occurred first) or up to data cutoff (Jan 2012 and Apr 2013 for Cohort 1 and Cohort 2, respectively), up to approximately 2.9 years|Full Analysis Set (ITT Analysis Set) included all participants who received at least 1 dose study drug.||Percentage of participants||95% Confidence Interval|Number
819433|NCT01136967|Primary|Objective Response Rate (ORR)|ORR was defined as the percentage of participants in each cohort who had a best overall response (BOR) of complete response (CR) or partial response (PR) based on Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 for target lesions and assessed by magnetic resonance imaging/computed tomography (MRI/CT) scans, as determined by independent radiologic review (IRR). A BOR of CR required confirmation by a subsequent CR assessment at least 4 weeks later. A BOR of PR required confirmation by a subsequent CR or PR assessment at least 4 weeks later. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 millimeters. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR = CR + PR.|From date of first dose of study drug until all participants completed a minimum of 6 cycles (28-day cycles) or discontinued treatment prior to end of Cycle 6 by the date of data cutoff (Jan 2012 and Apr 2013 for Cohort 1 and Cohort 2, respectively)|Full Analysis Set (Intent-to-Treat [ITT] Analysis Set) included all participants who received at least 1 dose study drug.||Percentage of participants||95% Confidence Interval|Number
819434|NCT01136967|Secondary|Disease Control Rate (DCR)|DCR was defined as the percentage of participants who had a BOR of CR or PR or stable disease (SD). To be assigned a BOR of SD, the time from the first administration of study drug until the date of documented SD needed to be greater than or equal to seven weeks based on IRR and Investigator's assessment. DCR = CR + PR + SD|From date of first dose of study drug until documentation of disease progression or death from any cause (whichever occurred first) or up to data cutoff (Jan 2012 and Apr 2013 for Cohort 1 and Cohort 2, respectively), up to approximately 2.9 years|Full Analysis Set (ITT Analysis Set) included all participants who received at least 1 dose study drug.||Percentage of participants||95% Confidence Interval|Number
819435|NCT01136967|Secondary|Overall Survival (OS)|OS was defined as the length of time in months from the date of first administration of study drug until the date of death from any cause, and was based on the data cutoff date for each cohort.|From date of first dose of study drug until date of death from any cause or up to data cutoff (Jan 2012 and Apr 2013 for Cohort 1 and Cohort 2, respectively), up to approximately 2.9 years|Full Analysis Set (ITT Analysis Set) included all participants who received at least 1 dose study drug.||Months||95% Confidence Interval|Median
819512|NCT01137474|Secondary|Adjusted Mean Change From Baseline in Seated Diastolic Blood Pressure at Week 12|All randomized participants who received at least 1 dose of study drug and who had nonmissing baseline and at least 1 postbaseline value during the double-blind treatment period were used for analysis.|From Baseline to Week 12|This study originally had 2 additional arms-dapagliflozin 2.5 and 5 mg-but randomization to these arms stopped when Protocol Amendment 8 (1-11-11) was implemented. Because endpoints focused only on 10-mg and placebo data, only patients in these arms who received study drug and who had nonmissing baseline and Week 12 values were included.||mm Hg||Standard Error|Mean
819436|NCT01136967|Secondary|Progression Free Survival (PFS)|PFS was measured as the time from the date of first administration of study treatment until the date of first documentation of disease progression or date of death from any cause (whichever occurred first), as determined by IRR and Investigator based on RECIST v1.1. Disease progression per RECIST v1.1 was defined as at least a 20% relative increase and 5 mm absolute increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions.|From date of first dose of study drug until documentation of disease progression or death from any cause (whichever occurred first) or up to data cutoff (Jan 2012 and Apr 2013 for Cohort 1 and Cohort 2, respectively), up to approximately 2.9 years|Full Analysis Set (ITT Analysis Set) included all participants who received at least 1 dose study drug.||Months||95% Confidence Interval|Median
819437|NCT01137032|Secondary|and the Number of Subjects With an Increment Between Basal and 30 Minutes Day 22 of at Least 7 ug/dL.||22 days|15 subjects represents the subgroup utilized for the analysis of this endpoint.||participants|||Number
819438|NCT01137032|Secondary|Pre-injection Serum Cortisol Levels|The number of subjects with pre-injection serum cortisol levels less than or equal to 5 ug/dL Day 22.|22 Days|15 subjects represents the subgroup utilized for the analysis of this endpoint.||participants|||Number
819439|NCT01137032|Primary|Post-injection Serum Cortisol Level|The number of subjects with a post-injection serum cortisol level less than or equal to 18 ug/dL on Day 22.|22 Days|15 subjects represents the subgroup utilized for the analysis of this endpoint.||participants|||Number
819440|NCT01137071|Secondary|Two-year Overall Survival: Median Time to Death|Overall survival was calculated as the time interval between the date of beginning of rescue platinum-based chemotherapy and date of death for any cause.|2-year overall survival rate after the beginning of rescue platinum-based chemotherapy.|Within the ITT population, 7 patients died and 22 were censored. The median time to death was 25.1 months (95% CI, 16.7 to 32.4 months).||months||95% Confidence Interval|Median
819441|NCT01137071|Secondary|Overall Mean Pharmacokinetic (PK) Data (Minimum and Maximum Concentrations)|Cmax = Peak (postdosing) Hu3S193 plasma concentration. Cmin = Trough (predosing) Hu3S193 plasma concentration (Cmin). Plasma concentration of Hu3S193 expressed in μg/mL.|Predose and Postdose on weeks 1, 2, 3, 4, 5, 7 and 9|PK samples were analyzed from 10 patients. Dose: 30 mg/m2 every two weeks||(µg/mL)||Standard Deviation|Mean
819442|NCT01137071|Secondary|Incidence of Serious Adverse Events (SAEs) - Musculoskeletal and Connective Tissue Disorders - Hip Fracture|A SAE was defined as an AE that met one of the following conditions: Death during the protocol-defined surveillance period; Potentially fatal event (defined as a patient at immediate risk of death at the time of the event); An event requiring the patient's hospitalization or prolongation of an existing hospitalization during the protocol-defined surveillance period; An event resulting in congenital anomaly or birth defect; An event resulting in a persistent or significant disability/incapacity; Any other major medical event that did not result in death, was not life threatening, or did not require hospitalization, but that could be considered a SAE when, based on the appropriate medical judgment, it presented a risk for the patient and required medical or surgical intervention to prevent one of the outcomes listed above.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
819443|NCT01137071|Secondary|Incidence of Serious Adverse Events (SAEs) - Gastrointestinal Disorders|A SAE was defined as an AE that met one of the following conditions: Death during the protocol-defined surveillance period; Potentially fatal event (defined as a patient at immediate risk of death at the time of the event); An event requiring the patient’s hospitalization or prolongation of an existing hospitalization during the protocol-defined surveillance period; An event resulting in congenital anomaly or birth defect; An event resulting in a persistent or significant disability/incapacity; Any other major medical event that did not result in death, was not life threatening, or did not require hospitalization, but that could be considered a SAE when, based on the appropriate medical judgment, it presented a risk for the patient and required medical or surgical intervention to prevent one of the outcomes listed above.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
819444|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Vascular Disorders; Respiratory, Thoracic and Mediastinal Disorders (Epistaxis)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
819445|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Vascular Disorders; Gastrointestinal Disorders (Haemorrhoids)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
819446|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Skin and Subcutaneous Tissue Disorders; Reproductive System and Breast Disorders (Vulvovaginal Pruritus)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
819528|NCT01137604|Secondary|Pharmacokinetic (PK) Profile and Pharmacodynamics (PD) of Lenvatinib|Due to the sparse PK sampling in this study, the data were pooled with data from other Phase 1 studies conducted in participants with solid tumors.|Blood samples collected at Cycle 1 on Days 1 and 15 and in Cycle 2 on Day 1||||||
819447|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Skin and Subcutaneous Tissue Disorders; Infections and Infestations (Tinea Pedis)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
819448|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Psychiatric Disorders; Nervous System Disorders (Insomnia)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
819449|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Nervous System Disorders; Psychiatric Disorders; Respiratory, Thoracic and Mediastinal Disorders (Hoarseness)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
819450|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Musculoskeletal and Connective Tissue Disorders; General Disorders and Administration Site Conditions; Renal and Urinary Disorders (Flank Pain)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
819451|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Investigations (Blood Cholesterol Increased)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
819452|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Infections and Infestations; Renal and Urinary Disorders (Urinary Tract Infection Bacterial)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
819453|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Infections and Infestations; Respiratory, Thoracic and Mediastinal Disorders (Bronchitis)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
819454|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Immune System Disorders; Blood and Lymphatic System Disorders; Injury, Poisoning and Procedural Complications (Transfusion Reaction)|The incidence of adverse events (percentage of patients with at least one adverse event and serious adverse events (overall and with reasonable relationship)) was assessed for the safety population|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
819455|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - General Disorders and Administration Site Conditions; Injury, Poisoning and Procedural Complications (Catheter Site Inflammation)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
819555|NCT01137812|Primary|Change in HbA1c From Baseline to Week 52|The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 52 for each treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the LS mean change.|Day 1 (Baseline) and Week 52|This analysis used the modified intent-to-treat analysis set (all patients who were randomly assigned to a treatment group and received at least 1 dose of study drug). The last-observation-carried-forward method was applied when the Week 52 values were missing. The table includes only patients with both baseline and post baseline values.||Percent||Standard Error|Least Squares Mean
819456|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - General Disorders and Administration Site Conditions; Injury, Poisoning and Procedural Complications (Hyperthermia)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
819457|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Gastrointestinal Disorders; Vascular Disorders (Anal Haemorrhage)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
819458|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Gastrointestinal Disorders; Reproductive System and Breast Disorders; Renal and Urinary Disorders (Pelvic Pain)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
819459|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Gastrointestinal Disorders; Infections and Infestations; Respiratory, Thoracic and Mediastinal Disorders (Pharyngitis)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
819460|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Eye Disorders (Ocular Hyperaemia)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
819461|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Endocrine Disorders; Metabolism and Nutrition Disorders (Hyperglycaemia)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
819462|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Ear and Labyrinth Disorders; Nervous System Disorders (Vertigo)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
819463|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Cardiac Disorders; Vascular Disorders; Nervous System Disorders (Dizziness)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
819464|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Skin and Subcutaneous Tissue Disorders; Injury, Poisoning and Procedural Complications|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
819571|NCT01138046|Secondary|Distribution Volume at Steady State (Vss) of Paclitaxel|Vss is the volume of distribution at steady state of paclitaxel. Vss was calculated from paclitaxel plasma concentration-time data on Day 1 and Day 8 with model-independent analyses|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Day 1 and Day 8 for paclitaxel|PK Population: all participants who provided blood samples for PK evaluation||milliliter per meters squared (mL/m^2)||95% Confidence Interval|Geometric Mean
819465|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Respiratory, Thoracic and Mediastinal Disorders; Cardiac Disorders (Dyspnoea)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
819466|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Reproductive System and Breast Disorders (Vulvovaginal Dryness)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
819467|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Renal and Urinary Disorders; Infections and Infestations (Urinary Tract Infection)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
819468|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Renal and Urinary Disorders (Dysuria)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
819469|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Psychiatric Disorders (Depression)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
819470|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Musculoskeletal and Connective Tissue Disorders; Injury, Poisoning and Procedural Complications|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
819471|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Musculoskeletal and Connective Tissue Disorders; General Disorders and Administration Site Conditions; Nervous System Disorders (Spinal Pain)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
819472|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Immune System Disorders; Respiratory, Thoracic and Mediastinal Disorders|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
819473|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Immune System Disorders; General Disorders and Administration Site Conditions; Injury, Poisoning and Procedural Complications (Infusion Related Reaction)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
819583|NCT01138098|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|After the challenge dose of Engerix™-B vaccine up to the study end|The Total Vaccinated cohort included all subjects who received the challenge dose of Engerix-B vaccine.||Subjects|||Number
819474|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Hepatobiliary Disorders; Injury, Poisoning and Procedural Complications (Hepatotoxicity)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
819475|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Ear and Labyrinth Disorders|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
819476|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Skin and Subcutaneous Tissue Disorders|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
819477|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - General Disorders and Administration Site Conditions; Musculoskeletal and Connective Tissue Disorders (Chills)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
819478|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Cardiac Disorders; General Disorders and Administration Site Conditions; Respiratory, Thoracic and Mediastinal Disorders (Chest Pain)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
819479|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Vascular Disorders|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
819480|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Psychiatric Disorders (Anxiety)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
819481|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Infections and Infestations; Respiratory, Thoracic and Mediastinal Disorders|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
819482|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Blood and Lymphatic System Disorders (Anaemia)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
819483|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Infections and Infestations; Gastrointestinal Disorders|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
819484|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Respiratory, Thoracic and Mediastinal Disorders|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
819485|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Investigations|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
819486|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Nervous System Disorders|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
819487|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Immune System Disorders|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
819488|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Musculoskeletal and Connective Tissue Disorders|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
819489|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - General Disorders and Administration Site Conditions|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
819490|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Gastrointestinal Disorders|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
819491|NCT01137071|Secondary|Safety - Vital Signs - Temperature|Vital signs during the study treatment (consolidation therapy). Through study completion, an average of 27 weeks.|Baseline, week 2, week 4 and week 27|All patients enrolled in this study received at least one dose of Hu3S193 (30 mg/m2) - ITT dataset. Baseline n=29, week 2 n=27, week 4 n= 28, week 27 n= 14||°C||Standard Deviation|Median
819492|NCT01137071|Secondary|Safety - Vital Signs - Systolic and Diastolic Blood Pressure|Both parameters were assessed throughout the study treatment. Vital signs during the study treatment (consolidation therapy). Through study completion, an average of 27 weeks.|Baseline, week 2, week 4 and week 27|All patients enrolled in this study received at least one dose of Hu3S193 (30 mg/m2) - ITT dataset. Diastolic Baseline n=29, week 2 n=27, week 4 n= 28, week 27 n= 14/ Systolic Baseline n=28, week 2 n=27, week 4 n= 28, week 27 n= 14||mmHg||Standard Deviation|Median
819493|NCT01137071|Secondary|Safety - Vital Signs - Respiratory Rate|Vital signs during the study treatment (consolidation therapy). Through study completion, an average of 27 weeks.|Baseline, week 2, week 4 and week 27|All patients enrolled in this study received at least one dose of Hu3S193 (30 mg/m2) – ITT dataset. Baseline n=29, week 2 n=27, week 4 n= 28, week 27 n= 14||ipm (Incursions per minute)||Standard Deviation|Median
819494|NCT01137071|Secondary|Safety - Vital Signs - Heart Rate|Vital signs were assessed throughout the study treatment (consolidation therapy).Through study completion, an average of 27 weeks.|Baseline, week 2 , week 4 and week 27|All patients enrolled in this study received at least one dose of Hu3S193 (30 mg/m2) – ITT dataset. Baseline n=29, week 2 n=27, week 4 n= 28, week 27 n= 14||bpm||Standard Deviation|Median
819495|NCT01137071|Secondary|Two-year Overall Survival Rate|Overall survival was calculated as the time interval between the date of beginning of rescue platinum-based chemotherapy and date of death for any cause.|2-year overall survival rate after the beginning of rescue platinum-based chemotherapy.|Within the ITT population, 7 patients died and 22 were censored. The 2-year overall survival rate was 70.7%.||percentage of participants|||Number
819706|NCT01130597|Secondary|Median Time to First Patiromer Dose Titration||56 Days|||days||95% Confidence Interval|Median
819497|NCT01137071|Primary|1-year PFS2 Rate After the Beginning of Rescue Platinum-based Chemotherapy|"PFS2 is defined by the interval from the beginning of rescue platinum-based chemotherapy until documented disease progression or death for any cause while the patient was under study or during the prolonged follow-up period.
Disease progression is defined by appearance of any new lesion (measurable and non-measurable) by the RECIST criteria. Disease progression date is the date when a new lesion is documented."|1-Year - From platinum-based rescue chemotherapy start date until documented disease progression or death of any cause whichever occurred first.|In the ITT (intention to treat) population, 25 patients out of the 29 considered for the PFS2 analysis presented disease progression or death and 4 were censored. The median time to disease progression or death was 11.8 months (95% CI (confidence interval), 10.6 to 13.9 months).||Months||95% Confidence Interval|Median
819498|NCT01137292|Primary|Number of Participants With Investigator's Satisfaction With the Tolerability of Voriconazole Assessment at the EOT Visit|Investigator's Satisfaction Responses: very good, good, moderate, poor. Responses were based on the investigator's judgement.|up to 2 weeks (EOT visit)|FAS. Number or participants analyzed = Number of participants with Investigator’s satisfaction response for the tolerability of voriconazole at the EOT Visit.||participants|||Number
819499|NCT01137292|Primary|Number of Participants With Investigator's Satisfaction With the Efficacy of Voriconazole Assessment at the EOT Visit|Investigator's Satisfaction Responses: very good, good, moderate, poor. Responses were based on the investigator's judgement.|up to 2 weeks (EOT visit)|FAS. Number or participants analyzed = Number of participants with Investigator’s satisfaction response for the efficacy of voriconazole at the EOT Visit.||participants|||Number
819500|NCT01137292|Primary|Number of Participants With Clinical and/or Mycological Efficacy by Response at the Test-of-Cure Visit|Clinical, mycological responses: clinical cure, clinical improvement, no clinical cure, mycological cure, no mycological cure, no mycological culture performed, death, and lost from follow-up. Participants could have had more than one response. Responses were based on the investigator's judgement according to the Infectious Disease Society of America, European Conference on Infections in Leukemia, and European Committee on Antimicrobial Susceptibility Testing guidelines.|more than 2 weeks (Test-of-Cure visit)|FAS.||participants|||Number
819501|NCT01137292|Primary|Number of Participants With Clinical and/or Mycological Efficacy by Response at the End of Treatment (EOT) Visit|Clinical, mycological responses: clinical cure, clinical improvement, no clinical cure, mycological cure, no mycological cure, and no mycological culture performed. Participants could have had more than one response. Responses were based on the investigator's judgement according to the Infectious Disease Society of America, European Conference on Infections in Leukemia, and European Committee on Antimicrobial Susceptibility Testing guidelines.|up to 2 weeks (EOT visit)|Full Analysis Set (FAS) = all enrolled participants who were administered the study medication and had post baseline documentation of efficacy available.||participants|||Number
819502|NCT01137370|Primary|Median 25-OHD Level||August 2010 to March 2011||10/2011||||
819503|NCT01137370|Primary|Prevalence of Vitamin D Deficiency||At enrollment|||participants, %|||Number
819504|NCT01137396|Secondary|Change in N3 (Slow-wave) Sleep Time||change from week 1 to week 2 of inpatient treatment|||minutes||Standard Error|Mean
819505|NCT01137396|Primary|%Cocaine Free Urines||3x/week|||percent||Standard Error|Mean
819506|NCT01137435|Other Pre-specified|Number of Reported Solicited Injection-Site and Systemic Events Following A Single Intramuscular Dose of Adacel™|"Solicited injection-site: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3 Solicited injection-site: Pain, Prevents daily activities; Erythema and Swelling,> 10 cm. Grade 3 Solicited systemic reactions: Fever, ≥39.0°C; Headache, Malaise, and Myalgia, Prevents daily activities.
All events reported by vaccinated subjects within 7 days post-vaccination during the 6 year post marketing surveillance period."|7 days post-vaccination|Safety events were assessed in the Safety Analysis Set.||Number of Events|||Number
819507|NCT01137435|Other Pre-specified|Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™|All adverse event reported by vaccinated subjects within 30 days post-vaccination during the 6 year post marketing surveillance period.|30 days post-vaccination|Safety events were assessed in the Safety Analysis Set.||Participants|||Number
819508|NCT01137435|Other Pre-specified|Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™|Unexpected adverse events reported by vaccinated subjects within 30 days post-vaccination during the 6 year post marketing surveillance period.|30 days post-vaccination|Safety events were assessed in the Safety Analysis Set.||Participants|||Number
819509|NCT01137435|Primary|Summary of Adverse Events Reported in Participants That Received a Single Intramuscular Dose of Adacel™|All adverse event reported by vaccinated subjects within 30 days post-vaccination during the 6 year post marketing surveillance period.|30 days post-vaccination|Safety events were assessed in the Safety Analysis Set.||Participants|||Number
819510|NCT01137474|Secondary|Adjusted Mean Change From Baseline in Serum Uric Acid Levels at Week 12|Central laboratory serum uric acid levels will be determined at the Enrollment, Day -28, Day 1, and at Week 4, 8, 12, and 13 visits. All randomized participants who received at least 1 dose of study drug and who had nonmissing baseline and at least 1 postbaseline value during the double-blind treatment period were used for analysis.|From Baseline to Week 12|This study originally had 2 additional arms-dapagliflozin 2.5 and 5 mg-but randomization to these arms stopped when Protocol Amendment 8 (1-11-11) was implemented. Because endpoints focused only on 10-mg and placebo data, only patients in these arms who received study drug and who had nonmissing baseline and Week 12 values were included.||mg/dL||Standard Error|Mean
819511|NCT01137474|Secondary|Adjusted Mean Change in 24-Hour Ambulatory Diastolic Blood Pressure at Week 12 (Last Observation Carried Forward [LOCF])|Ambulatory blood pressure monitoring was performed twice during the study, at baseline and at the end of study, for a duration of 24 hours each time. If the patient met the criteria for rescue due to hypertension, a second monitoring was performed prior to the first dose of rescue medication. Initiation of the 24-hour ambulatory blood pressure monitoring began between 6 and 11 am to ensure trough blood pressure measurements were obtained. Patients were instructed to withhold all medication on the morning of the study visit and to bring their medications to the visit with them.|From Baseline to Week 12|This study originally had 2 additional arms-dapagliflozin 2.5 and 5 mg-but randomization to these arms stopped when Protocol Amendment 8 (1-11-11) was implemented. Because endpoints focused only on 10-mg and placebo data, only patients in these arms who received study drug and who had nonmissing baseline and Week 12 values were included.||mm Hg||Standard Error|Mean
819513|NCT01137474|Secondary|Adjusted Mean Change From Baseline in 24-Hour Ambulatory Systolic Blood Pressure at Week 12 (Last Observation Carried Forward)|Ambulatory blood pressure monitoring was performed twice during the study, at baseline and at the end of study, for a duration of 24-hrs each time. If the patient met the criteria for rescue due to hypertension, a second monitoring was performed prior to the first dose of rescue medication. Initiation of the 24-hr ambulatory blood pressure monitoring began between 6 and 11 am to ensure trough blood pressure measurements were obtained. Patients were instructed to withhold all medication on the morning of the study visit and to bring their medications to the visit with them.|From Baseline to Week 12|This study originally had 2 additional arms-dapagliflozin 2.5 and 5 mg-but randomization to these arms stopped when Protocol Amendment 8 (1-11-11) was implemented. Because endpoints focused only on 10-mg and placebo data, only patients in these arms who received study drug and who had nonmissing baseline and Week 12 values were included.||mm Hg||Standard Error|Mean
819514|NCT01137474|Primary|Adjusted Mean Change From Baseline in Hemoglobin (HbA1c) at Week 12|HbA1c was measured as percent of hemoglobin by a central laboratory. All randomized participants who received at least 1 dose of study drug and who had nonmissing baseline and at least 1 postbaseline value during the double-blind treatment period were used for analysis. SD=standard deviation.|From Baseline to Week 12|This study originally had 2 additional arms-dapagliflozin 2.5 and 5 mg-but randomization to these arms stopped when Protocol Amendment 8 (1-11-11) was implemented. Because endpoints focused only on 10-mg and placebo data, only patients in these arms who received study drug and who had nonmissing baseline and Week 12 values were included.||Percent||Standard Error|Mean
819515|NCT01137474|Primary|Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure (BP) at Week 12|Seated BP was to be measured at every visit. Data after rescue medication was excluded. The patient first rested for at least 10 minutes in the seated position. Seated blood BP was determined from the mean of 3 replicated measurements obtained at least 1 minute apart. However, if the 3 consecutive seated BP readings were not within 8 mm Hg of each other, an additional 2 BP readings were to be obtained (total=5) and incorporated into the calculated mean for systolic BP and diastolic BP. For the initial BP recording, BP was measured in both arms. If the BP was higher in 1 arm, that arm was used for BP measurement. If there was no difference in BP measurements between arms, the dominant arm was used for all future BP measurements. All randomized participants who received at least 1 dose of study drug and who had nonmissing baseline and at least 1 postbaseline value during the double-blind treatment period were used for analysis. SD=standard deviation.|From Baseline to Week 12|This study originally had 2 additional arms-dapagliflozin 2.5 and 5 mg-but randomization to these arms stopped when Protocol Amendment 8 (1-11-11) was implemented. Because endpoints focused only on 10-mg and placebo data, only patients in these arms who received study drug and who had nonmissing baseline and Week 12 values were included.||mm Hg||Standard Error|Mean
819516|NCT01137539|Secondary|Patient Satisfaction|Positive response to a satisfaction question|12 months|49 subjects were analyzed at the 12 month period out of the total 50 subjects enrolled in the study.||Participants|||Count of Participants
819517|NCT01137539|Primary|Treatment Success Based on Patient Report on Validated Questionnaire|"Negative response to question #3 on the Urogenital Distress Inventory-6 (UDI-6) questionnaire. Question #3 states, Do you currently experience urine leakage related to physical activity, coughing or sneezing. If a subject answers No, this is considered success. If a subject answers Yes, this is considered failure of treatment."|24 months|46 subjects were analyzed at the 24 month period out of the total 50 subjects enrolled in the study.||Participants|||Count of Participants
819518|NCT01137578|Primary|All Participants With an Adjudicated Deep Vein Thromboembolism (DVT) By Study-Related Radiographic Procedures That Diagnosed the DVT|Adjudication was by an Independent Central Adjudication Committee (ICAC) consisting of experienced physicians not involved in the study and blinded to each participant’s identity and clinical course. One set of 3 study-related diagnostic imaging procedures (US, MRI with contrast, and MRI without contrast) was performed. Participants were considered positive for DVT if at least one of the radiographic procedures was positive.|Either Day 40±20 days following the placement of CVC (cohort A) or within 7 days of: symptoms of DVT or incidental diagnosis of CVC-related DVT(cohort B) or Day of MRI + 48 hours (cohort C)|n=participants with an adjudicated DVT identified by a study-related adjudicated radiographic procedure.||participants|||Number
819519|NCT01137578|Primary|Number of Participants With an Adjudicated Deep Vein Thrombosis (DVT) Detected By a Study-Related Ultrasound (US) and/or MRI, By Cohort and Age Group|MRI with contrast (c) and without (w/o) contrast (c) enhancement were performed and a US was done within 48 hours of the MRI. Once detected, the DVT was adjudicated and confirmed by an independent central adjudication Committee (ICAC) consisting of experienced physicians not involved in the study and blinded to each participant’s identity and clinical course. Participants were considered positive for DVT if at least one of the radiographic procedures was positive. Cohort A: Day 0=day of catheter placement; Day 40 (± 20 days)=day of imaging procedures at Visit 1, or if possible within 72 hours after a CVC is removed or lost. Cohort B Visit 1: within 7 days of initiation of symptoms of a CVC-related DVT (symptoms include but were not limited to: redness, pain/tenderness, swelling, presence of subcutaneous collaterals, catheter occlusion, and the presence of catheter related infection) or within 7 days of an incidental diagnosis of CVC-related DVT by radiographic imaging.|Either Day 40±20 days following the placement of CVC (cohort A) or within 7 days of: symptoms of DVT or incidental diagnosis of CVC-related DVT(cohort B) or Day of MRI + 48 hours (cohort C)|The imaged population included all enrolled participants who had at least one study-related diagnostic imaging procedure. n=number of adjudicated images||participants|||Number
819520|NCT01137578|Secondary|Number of Deaths Which Occurred During the Study|Death as an endpoint in a participant with an adjudicated venous thromboembolism (DVT or PE) was summarized, regardless of the cause of the death. The VTE was adjudicated by a blinded central independent adjudication committee.|Enrollment up to last US or MRI plus 30 days (up to approximately 90 days)|The imaged population included all enrolled participants who had at least one study-related diagnostic imaging procedure.||participants|||Number
819572|NCT01138046|Secondary|Time to the Maximum Drug Concentration (Tmax) of Lapatinib and Paclitaxel|Tmax is defined as the time to peak concentration from initiation of lapatinib and paclitaxel dosing. Tmax was calculated from lapatinib plasma concentration-time data on Day 8 and Day 14 and paclitaxel plasma concentration-time data on Day 1 and Day 8 with model-independent analyses|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Day 8 and Day 14 for lapatininb; Day 1 and Day 8 for paclitaxel|PK Population: all participants who provided blood samples for PK evaluation||Hr||Full Range|Median
819521|NCT01137578|Primary|Number of Participants and Reasons for Non-Completion of Each of the Imaging Procedures, Ultrasound (US), MRI With Contrast and MRI Without Contrast|Bilateral US was attempted but if it could not be completed, a unilateral US was accepted for analysis. Participants who did not complete the MRI procedure with contrast could be different participants from those who did not complete the MRI procedure without contrast. Primary reasons for non-completion of imaging included: technical, investigator decision, child refused, parent refused, child missed appointment, difficulties with anesthesia/sedation, child unable to lie still, problems with contrast administration, and other reasons. Other reasons could include: late to appointment and unable to perform MRI due to time constraints; logistical reasons, parent agreed to only ultrasound at time of consent, schedule delay, equipment not available, difficulty putting patient in correct position. Due to the small numbers of participants in some cohorts, these data were more meaningful with all cohorts grouped together for the total imaged population.|Either Day 40±20 days following the placement of CVC (cohort A) or within 7 days of: symptoms of DVT or incidental diagnosis of CVC-related DVT(cohort B) or Day of MRI + 48 hours (cohort C).|Participants had at least 1 radiographic procedure performed but were unable to complete a either an Ultrasound (neither bilateral or unilateral, or could complete only a unilateral US) and/or unable to complete an MRI with contrast and/or unable to complete an MRI without contrast.||participants|||Number
819522|NCT01137578|Primary|Number of Participants Who Required Sedation/Anesthesia With the Study-Related Radiographic Procedures, by Cohort and Age|One set of diagnostic imaging procedures (US and MRI) was to be performed for all cohorts The MRI consisted of MRI venous imaging without contrast enhancement and MRI venous imaging with contrast enhancement.|Either Day 40±20 days following the placement of CVC (cohort A) or within 7 days of: symptoms of DVT or incidental diagnosis of CVC-related DVT(cohort B) or Day of MRI + 48 hours (cohort C).|The imaged population included all participants who had at least 1 study-related diagnostic imaging procedure.||participants|||Number
819523|NCT01137578|Secondary|Number of Participants With Adjudicated Pulmonary Embolism (PE) Events (Symptomatic or Asymptomatic) Identified During the Study|Signs and symptoms of PE include shortness of breath, pleuritic pain, cough, orthopnea, wheezing, and may have associated signs and symptoms of DVT. In the event a PE was detected while undergoing the study MRI or other imaging procedure required for care of an underlying condition, and the participant did not manifest any signs and/or symptoms of a PE, the event was considered an asymptomatic PE. The participant was managed and further investigated according to the investigator’s standard of care. All diagnostic imaging procedures performed, such as contrast-enhanced computer tomography (CT) pulmonary angiogram, nuclear ventilation perfusion lung scan (V/Q scan), were submitted for adjudication as a suspected PE.|Enrollment up to Visit 1 plus 30 days (up to approximately 90 days)|The imaged population included all enrolled participants who had at least one study-related diagnostic imaging procedure.||participants|||Number
819524|NCT01137578|Secondary|Number of All Participants Identified With Adjudicated DVT Categorized By Presence or Absence of Symptoms at Enrollment|Adjudication was by an ICAC consisting of experienced physicians not involved in the study and blinded to each participant’s identity and clinical course. One set of Study-related diagnostic imaging procedures (US, MRI with contrast, and MRI without contrast) was performed for all cohorts. Participants were considered positive for DVT if at least one of the radiographic procedures was positive.|Either Day 40±20 days following the placement of CVC (cohort A) or within 7 days of: symptoms of DVT or incidental diagnosis of CVC-related DVT(cohort B) or Day of MRI + 48 hours (cohort C)|All participants who had an adjudicated DVT identified by at lest one study-related radiographic procedure.||Participants|||Number
819525|NCT01137578|Primary|Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group|Imaging was performed on Visit 1 which was defined for Cohort A as: Day 40 ± 20 days from Day 0, the placement of the central venous catheter (CVC), or if possible within 72 hours after a CVC was removed or lost; Visit 1 defined for Cohort B: within 7 days of initiation of symptoms of a CVC-related deep vein thromboembolism (DVT) or within 7 days of an incidental diagnosis of CVC-related DVT by radiographic imaging. Cohort C participants had an ultrasound done within 48 hours of the performance of the MRI. All 3 imaging procedures, ultrasound, MRI with contrast, MRI without contrast were to be performed on all participants, regardless of the cohort.|Either Day 40±20 days following the placement of CVC (cohort A) or within 7 days of: symptoms of DVT or incidental diagnosis of CVC-related DVT(cohort B) or Day of MRI + 48 hours (cohort C)|The imaged population included all enrolled participants who had at least 1 study-related diagnostic imaging procedure.||participants|||Number
819526|NCT01137578|Primary|Total Number of Participants Who Completed the Study-Related Ultrasound (US) and Magnetic Resonance Imaging (MRI) With and Without Contrast|One set of 3 diagnostic imaging procedures (US, MRI with contrast, and MRI without contrast) was performed for all cohorts. Imaging was performed on Visit 1, which in Cohort A was Day 40 ± 20 days from Day 0, the placement of the central venous catheter (CVC), or if possible within 72 hours after a CVC was removed or lost; Visit 1 in Cohort B was within 7 days of initiation of symptoms of a CVC-related deep vein thromboembolism (DVT) or within 7 days of an incidental diagnosis of CVC-related DVT by radiographic imaging. Cohort C participants had an ultrasound done within 48 hours of the performance of the MRI, which was scheduled for a clinical reason. Note: participants completing each MRI procedure (with contrast or without contrast) could be different participants.|Either Day 40±20 days following the placement of CVC (cohort A) or within 7 days of: symptoms of DVT or incidental diagnosis of CVC-related DVT(cohort B) or Day of MRI + 48 hours (cohort C).|The imaged population included all enrolled participants who had at least 1 study-related diagnostic imaging procedure.||participants|||Number
819527|NCT01137604|Primary|Progression Free Survival (PFS) Rate at Month 6|PFS at Month 6 was defined as the percentage of participants who remained alive and progression-free at Month 6, based on investigator's assessment. Progression was defined using Response Assessment in Neuro-Oncology (RANO) criteria, as a greater than 25% increase in enhancing lesions despite stable or increasing steroid dose, an increase (significant) in non-enhancing T2-weighted-Fluid-Attenuated Inversion Recovery (T2/FLAIR) lesions that are not attributable to other non-tumor causes, and any new lesions. PFS rate at Month 6 was estimated from Kaplan-Meier (K-M) product-limit estimate of PFS.|At Month 6 from randomization (Cohort 1) or first day of treatment (Cohorts 2 and 3)|Full Analysis Set included all participants who received at least one dose of study drug||Percentage of participants||95% Confidence Interval|Number
819707|NCT01130597|Secondary|Percentage of Participants Requiring Patiromer Downtitration||56 Days|||percentage of participants|||Number
819529|NCT01137604|Secondary|Number of Participants With Adverse Events (AEs)/Serious Adverse Events (SAEs) as a Measure of Safety|Safety was assessed by monitoring and recording all AEs including all Common Terminology Criteria for Adverse Events (CTCAE) grades (for both increasing and decreasing severity) and SAEs; regular monitoring of hematology, clinical chemistry, and urine values; results of physical examinations, regular measurement of vital signs, and electrocardiograms (ECGs), as detailed in the Schedule of Visits and Procedures. The relationship of AEs to treatment was based on investigator judgment. Details of AEs and SAEs are provided in the reported adverse event section.|For each participant, from the first patient first dose till 30 days after the last dose or the cut-off date of 19 March 2013 (ie, 2.4 years)|Full Analysis Set - all participants who received at least one dose of study drug||Participants|||Number
819530|NCT01137604|Secondary|Clinical Benefit Rate (CBR)|CBR was the percentage of the participants who had BOR of CR, PR, and SD with the minimum duration of SD lasting greater than or equal to 23 weeks. Only participants with measurable disease at baseline were included in evaluation of CBR, based on investigator's assessment.|From date of randomization (Cohort 1) or first day of treatment (Cohorts 2 and 3) until disease progression, development of unacceptable toxicity, withdrawal of consent or up to data cutoff date of 19 March 2013 (ie, 2.4 years)|Full Analysis Set - all participants who received at least one dose of study drug||Percentage of participants||95% Confidence Interval|Number
819531|NCT01137604|Secondary|Disease Control Rate (DCR)|DCR was the percentage of the participants who had BOR of CR, PR, and stable disease (SD) with the minimum duration of SD lasting greater than or equal to 7 weeks. Only participants with measurable disease at baseline were included in evaluation of DCR, based on investigator's assessment.|From date of randomization (Cohort 1) or first day of treatment (Cohorts 2 and 3) until disease progression, development of unacceptable toxicity, withdrawal of consent or up to data cutoff date of 19 March 2013 (ie, 2.4 years)|Full Analysis Set - all participants who received at least one dose of study drug||Percentage of participants||95% Confidence Interval|Number
819532|NCT01137604|Secondary|Overall Survival (OS)|OS was measured as the time from the randomization date (Cohort 1) or the first day of treatment (Cohort 2 and 3) to the date of death from any cause.|From date of randomization (Cohort 1) or first day of treatment (Cohorts 2 and 3) until death due to any cause or up to data cutoff date of 19 March 2013 (ie, 2.4 years)|Full Analysis Set - all participants who received at least one dose of study drug||Months||95% Confidence Interval|Median
819533|NCT01137604|Secondary|Progression Free Survival|PFS was measured as the time from randomization (Cohort 1) or the first day of treatment (Cohorts 2 and 3) until the date of first documentation of disease progression or date of death, if death occurred prior to disease progression, based on investigator's assessment.|From date of randomization (Cohort 1) or first day of treatment (Cohorts 2 and 3) until disease progression, development of unacceptable toxicity, withdrawal of consent or up to data cutoff date of 19 March 2013 (ie, 2.4 years)|Full Analysis Set - all participants who received at least one dose of study drug||Months||95% Confidence Interval|Median
819534|NCT01137604|Secondary|Objective Response Rate (ORR)|ORR was the percentage of participants with best overall response (BOR) of complete response (CR) and partial response (PR) based on RANO criteria and investigator's assessment. CR was defined as the disappearance of all enhancing disease (measurable and non-measurable) sustained for at least 4 weeks, no new lesions, and stable or improved non-enhancing (T2/FLAIR) lesions. PR was defined as greater than or equal to 50% decrease, compared to baseline, in the sum of products of perpendicular diameters of all measureable enhancing lesions sustained for at least 4 weeks. No progression of non-measurable disease, no new lesions, stable or improved non-enhancing (T2/FLAIR) lesions on same or lower dose of corticosteroids compared to baseline. For both CR and PR, in the absence of a confirming scan 4 weeks later, this scan was considered only stable disease. Only participants with measureable disease at baseline were included in evaluation of ORR.|From date of randomization (Cohort 1) or first day of treatment (Cohorts 2 and 3) until disease progression, development of unacceptable toxicity, withdrawal of consent or up to data cutoff date of 19 March 2013 (i.e., 2.4 years)|Full Analysis Set included all participants who received at least one dose of study drug||Percentage of participants||95% Confidence Interval|Number
819535|NCT01137682|Secondary|PK Levels of Pasireotide LAR 40 mg and Pasireotide LAR 60 mg||24 Weeks||02/2018||||
819536|NCT01137682|Secondary|Change From Baseline in Health Related QoL as Measured by the AcroQoL (Acromegaly Health Related QoL)||Baseline, 24 Weeks||02/2018||||
819537|NCT01137682|Secondary|Change From Baseline in Clinical Signs/Symptoms of Acromegaly (Ring Size; Headache, Fatigue, Perspiration, Paresthesias and Osteoarthralgia According to a Five-point Score Scale)||Baseline, 24 Weeks||02/2018||||
819538|NCT01137682|Secondary|Percent Change in Tumor Volume Assessed by Pituitary MRI.||Baseline, 24 Weeks||02/2018||||
819539|NCT01137682|Secondary|Percentage of Participants Achieving a Tumor Volume Reduction > 25% Assessed by Pituitary MRI.||24 Weeks||02/2018||||
819540|NCT01137682|Secondary|Percentage of Participants Achieving GH Levels < 1 µg/L.||Weeks 12 and 24||02/2018||||
819541|NCT01137682|Secondary|Percentage of of Participants Achieving GH Levels < 1 µg/L and Normal, Sex- and Age-adjusted IGF-1.||Weeks 12 and 24||02/2018||||
819542|NCT01137682|Secondary|Percentage of Participants Achieving GH Levels < 2.5 µg/L.||Weeks 12 and 24||02/2018||||
819543|NCT01137682|Secondary|Percentage of Participants Achieving Biochemical Control Defined as Mean GH Levels < 2.5 µg/L and Normalization of Sex- and Age-adjusted IGF-1.||12 Weeks||02/2018||||
819544|NCT01137682|Secondary|Perecentage of Participants Achieving Normalization of Sex- and Age-adjusted IGF-1|The key secondary objective is to compare the effect of pasireotide LAR (40 mg and 60 mg separately) versus continuing the same treatment on the proportion of patients achieving normalization of sex- and age-adjusted IGF-1 at 24 weeks. The endpoint for the key secondary objective is the proportion of patients achieving normalization of sex- and age-adjusted IGF-1 at 24 weeks.|24 weeks|Full analysis set (FAS): comprised all patients who were randomized. Following the intent-to-treat principle, patients were analyzed according to the study drug they were assigned to at randomization and actual stratum.||Percentage of Participants||95% Confidence Interval|Number
819611|NCT01138150|Primary|Change in the Total Serum Adiponectin (T-ADP)|Change in total serum adiponectin after treatment in responders and non responders|30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment|||ug/mL||95% Confidence Interval|Mean
819708|NCT01130597|Secondary|Percentage of Participants Requiring Patiromer Uptitration||56 Days|||percentage of participants|||Number
819545|NCT01137682|Primary|Percentage of Participants With a Reduction of Mean GH Levels to < 2.5 µg/L and Normalization of Sex- and Age-adjusted IGF-1.|The primary objective of this study was to compare the proportion of patients achieving biochemical control (defined as mean GH levels <2.5 µg/L and normalization of sex- and age- adjusted IGF-1) at 24 weeks with pasireotide LAR 40 mg and pasireotide LAR 60 mg separately versus continued treatment with octreotide LAR 30 mg or lanreotide autogel (ATG) 120 mg. The primary efficacy variable is the proportion of patients with a reduction of mean GH levels to < 2.5 µg/L and normalization of sex- and age-adjusted IGF-1 at 24 weeks.|24 weeks|Full analysis set (FAS): comprised all patients who were randomized. Following the intent-to-treat principle, patients were analyzed according to the study drug they were assigned to at randomization and actual stratum.||Percentage of Participants||95% Confidence Interval|Number
819546|NCT01137773|Secondary|Blood Glucose Concentration|average blood glucose concentration while the patients received insulin drip|24 h|||mg/dl blood||Standard Deviation|Mean
819547|NCT01137773|Primary|Karnovsky Performance Status Scale of Functional Impairment|"The Karnofsky Performance Scale Index allows patients to be classified as to their functional impairment. It can be used to compare effectiveness of different therapies and to assess the prognosis in individual patients. The lower the Karnofsky score, the worse the survival for most serious illnesses. Patients are assigned a value from 0 to 100 based on the following definitions:
Normal no complaints; no evidence of disease - 100 Able to carry on normal activity; minor signs or symptoms of disease- 90 Normal activity with effort; some signs or symptoms of disease - 80 Cares for self; unable to carry on normal activity or to do active work - 70 Requires occasional assistance, but is able to care for most of his personal needs - 60 Requires considerable assistance and frequent medical care - 50 Disabled; requires special care and assistance - 40 Severely disabled; hospital admission is indicated although death not imminent - 30 Very sick; hospital admission necessary; active s"|3 months|||units on a scale||Standard Deviation|Mean
819548|NCT01137786|Primary|Impact on the Trajectory of Serum and Urinary NGAL Following the Administration of Non-ionic Low Osmolar Contrast Media.|Mean change from baseline values for serum NGAL at 2,4,6,24,48 and 72 hours, and urine NGAL at 2,4,6,24, and 48 hours following the administration of non-ionic low osmolar contrast media.|Baseline and 2, 4, 6, 24, 48, and 72 hours post-dose|||ng/mL||Standard Deviation|Mean
819549|NCT01137812|Secondary|Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 52|The table below shows the mean percent change in HDL-C from Baseline to Week 52 for each treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the LS mean change.|Day 1 (Baseline) and Week 52|This analysis used the modified intent-to-treat analysis set (all patients who were randomly assigned to a treatment group and received at least 1 dose of study drug). The last-observation-carried-forward method was applied when the Week 52 values were missing. The table includes only patients with both baseline and post baseline values.||Percent change||Standard Error|Least Squares Mean
819550|NCT01137812|Secondary|Percent Change in Triglycerides From Baseline to Week 52|The table below shows the mean percent change in triglycerides from Baseline to Week 52 for each treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the LS mean change.|Day 1 (Baseline) and Week 52|This analysis used the modified intent-to-treat analysis set (all patients who were randomly assigned to a treatment group and received at least 1 dose of study drug). The last-observation-carried-forward method was applied when the Week 52 values were missing. The table includes only patients with both baseline and post baseline values.||Percent change||Standard Error|Least Squares Mean
819551|NCT01137812|Secondary|Change in Systolic Blood Pressure (SBP) From Baseline to Week 52|The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 52 for each treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the LS mean change.|Day 1 (Baseline) and Week 52|This analysis used the modified intent-to-treat analysis set (all patients who were randomly assigned to a treatment group and received at least 1 dose of study drug). The last-observation-carried-forward method was applied when the Week 52 values were missing. The table includes only patients with both baseline and post baseline values.||mmHg||Standard Error|Least Squares Mean
819552|NCT01137812|Secondary|Percent Change in Body Weight From Baseline to Week 52|The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 52 for each treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the LS mean percent change.|Day 1 (Baseline) and Week 52|This analysis used the modified intent-to-treat analysis set (all patients who were randomly assigned to a treatment group and received at least 1 dose of study drug). The last-observation-carried-forward method was applied when the Week 52 values were missing. The table includes only patients with both baseline and post baseline values.||Percent change||Standard Error|Least Squares Mean
819553|NCT01137812|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 52|The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 52 for each treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the LS mean change.|Day 1 (Baseline) and Week 52|This analysis used the modified intent-to-treat analysis set (all patients who were randomly assigned to a treatment group and received at least 1 dose of study drug). The last-observation-carried-forward method was applied when the Week 52 values were missing. The table includes only patients with both baseline and post baseline values.||mg/dL||Standard Error|Least Squares Mean
819554|NCT01137812|Secondary|Percentage of Patients With HbA1c <7% at Week 52|The table below shows the percentage of patients with HbA1c <7% at Week 52 in each treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the percentage.|Week 52|This analysis used the modified intent-to-treat analysis set (all patients who were randomly assigned to a treatment group and received at least 1 dose of study drug). The last-observation-carried-forward method was applied when the Week 52 values were missing. The table includes only patients with both baseline and post baseline values.||Percentage of patients|||Number
819573|NCT01138046|Secondary|AUC From Time Zero to Infinity (0-INF) of Paclitaxel|AUC(0-INF) is area under the plasma concentration-time curve from time 0 extrapolated to infinity. AUC (0-INF) was calculated from paclitaxel plasma concentration-time data on Day 1 and Day 8 with model-independent analyses|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Day 1 and Day 8 for paclitaxel|PK Population: all participants who provided blood samples for PK evaluation||hr*ng/mL||95% Confidence Interval|Geometric Mean
819556|NCT01137890|Secondary|Drug Value Questionnaire|"Street Value of Sampled Dose. After co-administration of cocaine-zonisamide, participants were asked to hypothetically estimate the value of the drug they received, if they were to purchase it on the street. The mean value (dollars) across all drug conditions is reported here.
Repeated within-subject measures ANOVA performed to observe the main effects of zonisamide dose (0, 300, and 600mg) and cocaine dose (0, 20, and 40mg), and their interaction. Only participants who received the active zonisamide medication (n=8) were included in this portion of the analysis. Additionally, all 8 subjects who received zonisamide completed both 300mg and 600mg doses.
Within-subject repeated interval during self-administration sessions. Cocaine not administered (only Zon) during Weeks 2 & 4, thus no measures taken at these times"|Weeks 1-5; mean of weeks 1, 3 and 5 reported|Because we are interested in how co-administration cocaine-zon affects this measure, only zon participants are included (n=8). Each participant receives varying doses of zon (0, 300, 600mg) at weeks 1, 2-3, 4-5, respectively. After getting used to each zon dose, they are co-administered all 3 cocaine doses (1, 20, 40mg) during Weeks 1, 3, and 5||dollars||Standard Deviation|Mean
819557|NCT01137890|Primary|Cocaine Craving|Cocaine craving measured by Cocaine Selectivity Severity Assessment (CSSA). The CSSA is a reliable and valid tool to measure cocaine withdrawal severity within a 24 hr period, and has been shown to predict treatment response in a treatment setting. Participants are asked to rate 18-items on a Likert scale 0-7, with composite scores ranging 0-126 and higher numbers indicative of more severe withdrawal. Mean scores on CSSA across 39-day time period are reported.|Day 1-39|Includes all participants analyzed (n=12; 8 zonisamide, 4 placebo)||units on a scale||Standard Deviation|Mean
819558|NCT01137890|Primary|Behavioral Choice Measures|"In each condition of cocaine-zonisamide dose, participants were asked to choose whether they would rather have a repeated cocaine dose (same dose as most recent administration) or cash of varying monetary value. The mean number of cocaine choices across each drug condition are reported. This measure only included participants in the zonisamide (Zon) condition (n=8), with each arm representing variation in co-administration of cocaine-Zon.
Repeated within-subject measures ANOVA performed to observe the main effects of zonisamide dose (0, 300, and 600mg) and cocaine dose (1, 20, and 40mg), and their interaction. Only participants who received the active zonisamide medication (n=8) were included in this portion of the analysis.
During self-administration sessions are every 15 min over 1hr45min period. Assessment on Weeks 1 (0mg Zon), 3 (300mg Zon), 5 (600mg Zon), in which varying cocaine doses co-administered. Cocaine not administered (only Zon) during Weeks 2 & 4"|Weeks 1-5, mean of weeks 1, 3 and 5 reported|Because we are interested in how co-administered of cocaine-Zon affects this measure, only Zon participants are included (n=8). Each participant receives varying doses of Zon (0, 300, 600mg) at weeks 1, 2-3, 4-5, respectively. After getting used to each Zon dose, they are co-administered all 3 cocaine doses (1, 20, 40mg) during Weeks 1, 3, and 5||number of cocaine choices||Standard Deviation|Mean
819559|NCT01137890|Primary|Change in Visual Analog Questionnaire (VAQ) Score|VAQ measures the change in effect after dose administration. Participants rate 6 items (“Any Drug Effect”, “Rush”, “Good Effects”, “Bad Effects”, “Liking”, & “Desire for Cocaine”) by pointing an arrow along a 100-point line anchored at either end with “none” (0) & “extremely” (100). Each participant’s score is equal to the sum of all 6 ratings, & the mean of all participant’s scores is reported across each condition. The VAQ is only administered to subjects in the zonisamide (Zon) condition (n=8). Repeated within-subject measures ANOVA performed to observe the main effects of Zon dose (0, 300, & 600mg) & cocaine dose (1, 20, & 40mg), & their interaction. All 8 subjects who received Zon completed both 300mg & 600mg doses. Assessments obtained on Week 1 (0mg Zon), Week 3 (300mg Zon), & Week 5 (600mg Zon), in which all 3 cocaine were co-administered at these times. Cocaine not administered (only Zon) during Weeks 2 & 4, thus no measures taken at these times|Weeks 1-5; mean of weeks 1, 3 and 5 reported|Because we are interested in how co-administered of cocaine-Zon affects this measure, only Zon participants are included (n=8). Each participant receives varying doses of Zon (0, 300, 600mg) at weeks 1, 2-3, 4-5, respectively. After getting used to each Zon dose, they are co-administered all 3 cocaine doses (1, 20, 40mg) during Weeks 1, 3, and 5||units on a scale||Standard Deviation|Mean
819560|NCT01138007|Secondary|Change From Baseline in the IDS-SR Subscores for Energy, Pleasure, and Interest at Weeks 1, 2, 4, 6, and 8|The IDS-SR is a 30-item scale used to evaluate the severity and changes in depressive symptoms. Each item was scored from 0 (no symptoms) to 3 (greatest symptom severity). Only five items (item 19: general interest; item 20: energy level; item 21: capacity for pleasure or enjoyment, excluding sex; item 22: interest in sex; item 30: leaden paralysis/physical energy) were evaluated for this endpoint, as a subset of the total score. The lowest possible total score and subset total score of IDS-SR are 0 and 0, and the highest possible total score and subset total score of IDS-SR are 84 and 15, respectively. Change from Baseline was calculated as the value at Week 1, 2, 4, 6, and 8 minus the value at Baseline. The least squared means were estimated based on the ANCOVA model including Baseline IDS-SR subscore and region as covariates.|Baseline; Weeks 1, 2, 4, 6, and 8|FAS. Missing values were imputed using LOCF. Only participants who were available at the specified time points were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
819561|NCT01138007|Secondary|Change From Baseline in the Inventory of Depressive Symptomatology-Self Report (IDS-SR) Total Score at Weeks 1, 2, 4, 6, and 8|The IDS-SR is a 30-item scale used to evaluate the severity and changes in depressive symptoms. Each item was scored from 0 (no symptoms) to 3 (greatest symptom severity). The maximum total score is 84 (0: no symptoms; 84: greatest symptom severity), as participants were asked to answer either item 11 (decreased appetite) or item 12 (increased appetite) (not both) and either item 13 (decreased weight) or item 14 (increased weight) (not both). Change from Baseline was calculated as the value at Week 1, 2, 4, 6, and 8 minus the value at Baseline. The least squared means were estimated based on the ANCOVA model including Baseline IDS-SR score and region as covariates.|Baseline; Weeks 1, 2, 4, 6, and 8|FAS. Missing values were imputed using LOCF. Only participants who were available at the specified time points were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
819574|NCT01138046|Secondary|Area Under the Concentration-time Curve (AUC) (0-24) of Lapatinib and Paclitaxel|AUC is defined as the area under the lapatinib or paclitaxel concentration-time curve from time 0 to 24 hours (hrs). AUC (0-24) was calculated from lapatinib plasma concentration-time data on Day 8 and Day 14 and paclitaxel plasma concentration-time data on Day 1 and Day 8 with model-independent analyses|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Day 8 and Day 14 for lapatininb; Day 1 and Day 8 for paclitaxel|PK Population: all participants who provided blood samples for PK evaluation||hours * nanograms/milliliter (hr*ng/mL)||95% Confidence Interval|Geometric Mean
819562|NCT01138007|Secondary|Change From Baseline in the Clinical Global Impression-Severity of Illness (CGI-SI) Scores at Weeks 1, 2, 4, 6, and 8|A CGI-SI assessment was performed in terms of severity in depression, by using scores from 0 to 7: 0, Not assessed; 1, Normal, not at all ill; 2, Borderline mentally ill; 3, Mildly ill; 4, Moderately ill; 5, Markedly ill; 6, Severely ill; 7, Among the most extremely ill participants. Change from Baseline in the CGI-SI score was calculated as the value at Week 1, 2, 4, 6, and 8 minus the value at Baseline. The least squared means were estimated based on the ANCOVA model including Baseline CGI-SI score and region as covariates.|Baseline; Weeks 1, 2, 4, 6, and 8|FAS. Missing values were imputed using LOCF. Only participants who were available at the specified time points were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
819563|NCT01138007|Secondary|Number of Clinical Global Impression-Global Improvement (CGI-GI) Responders at Week 8|A CGI-GI assessment was performed at Week 8 (or withdrawal) in comparison with severity in depression observed at Baseline (Week 0; no actual assessment was performed at Baseline [the comparison was subjective]), by using scores from 0 to 7: 0, Not assessed; 1, Very much improved; 2, Much improved; 3, Minimally improved; 4, No change; 5, Minimally worse; 6, Much worse; 7, Very much worse. A CGI-GI responder is defined as a participant with a CGI-GI score of very much improved or much improved at Week 8.|Week 8|FAS. Missing values were imputed using LOCF. Only those participants who were available at Week 8 were analyzed.||participants|||Number
819564|NCT01138007|Secondary|Number of MADRS Remitters at Week 8|The MADRS scale measures the depression level of a participant. The total score was derived by adding the scores of the following 10 items: 1, Apparent sadness; 2, Reported sadness; 3, Inner tension; 4, Reduced sleep; 5, Reduced appetite; 6, Concentration difficulties; 7, Lassitude; 8, Inability to feel; 9, Pessimistic thoughts; 10, Suicidal thoughts. Each item was scored using a scale of 0 to 6 (a higher score indicates increased severity). The maximum total score is 60; 0, no depression; 60, severely depressed. A MADRS remitter is defined as a participant with a MADRS total score <=11 at Week 8.|Week 8|FAS. Missing values were imputed using LOCF.||participants|||Number
819565|NCT01138007|Secondary|Number of MADRS Responders at Week 8|The MADRS scale measures the depression level of a participant. The total score was derived by adding the scores of the following 10 items: 1, Apparent sadness; 2, Reported sadness; 3, Inner tension; 4, Reduced sleep; 5, Reduced appetite; 6, Concentration difficulties; 7, Lassitude; 8, Inability to feel; 9, Pessimistic thoughts; 10, Suicidal thoughts. Each item was scored using a scale of 0 to 6 (a higher score indicates increased severity). The maximum total score is 60; 0, no depression; 60, severely depressed. A MADRS responder is defined as a participant with a >=50% reduction from Baseline in the MADRS total score at Week 8.|Baseline and Week 8|FAS. Missing values were imputed using LOCF.||participants|||Number
819566|NCT01138007|Secondary|Change From Baseline in the MADRS Individual Item Scores at Weeks 1, 2, 4, 6, and 8|The MADRS scale measures the depression level of a participant using the following 10 items: 1, Apparent sadness; 2, Reported sadness; 3, Inner tension; 4, Reduced sleep; 5, Reduced appetite; 6, Concentration difficulties; 7, Lassitude; 8, Inability to feel; 9, Pessimistic thoughts; 10, Suicidal thoughts. Each item was scored using a scale of 0 to 6 (a higher score indicates increased severity). Scores for MADRS items 1, 2, 6, 7, and 8 were evaluated for this endpoint. Change from Baseline was calculated as the value at Week 1, 2, 4, 6, and 8 minus the value at Baseline. The least squared means were estimated based on the ANCOVA model including Baseline MADRS score of each item and region as covariates.|Baseline; Week 1, 2, 4, 6, and 8|FAS. Missing values were imputed using LOCF. Only participants who were available at the specified time points were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
819567|NCT01138007|Secondary|Change From Baseline in the MADRS Total Score at Weeks 1, 2, 4, and 6|The MADRS scale measures the depression level of a participant. The total score was derived by adding the scores of the following 10 items: 1, Apparent sadness; 2, Reported sadness; 3, Inner tension; 4, Reduced sleep; 5, Reduced appetite; 6, Concentration difficulties; 7, Lassitude; 8, Inability to feel; 9, Pessimistic thoughts; 10, Suicidal thoughts. Each item was scored using a scale of 0 to 6 (a higher score indicates increased severity). The maximum total score is 60; 0, no depression; 60, severely depressed. Change from Baseline in the total score was calculated as the value at Week 1, 2, 4 and 6 minus the value at Baseline. The least squared means were estimated based on the ANCOVA model including Baseline MADRS score and region as covariates.|Baseline; Weeks 1, 2, 4, and 6|FAS. Missing values were imputed using LOCF. Only participants who were available at the specified time points were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
819568|NCT01138007|Primary|Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 8/Withdrawal|The MADRS scale measures the depression level of a participant. The total score was derived by adding the scores of the following 10 items: 1, Apparent sadness; 2, Reported sadness; 3, Inner tension; 4, Reduced sleep; 5, Reduced appetite; 6, Concentration difficulties; 7, Lassitude; 8, Inability to feel; 9, Pessimistic thoughts; 10, Suicidal thoughts. Each item was scored using a scale of 0 to 6 (a higher score indicates increased severity). The maximum total score is 60; 0, no depression; 60, severely depressed. Change from Baseline in the total score was calculated as the value at Week 8/Withdrawal minus the value at Baseline. The least squared means were estimated based on the Analysis of Covariance (ANCOVA) model including Baseline MADRS score and region as covariates.|Baseline and Week 8/Withdrawal|Full Analysis Set (FAS): all participants who took at least one dose of investigational product and provided at least one efficacy observation at a Treatment Phase visit (i.e. Week 1 or later). Missing values were imputed using Last Observation Carried Forward (LOCF): last observed non-missing value was used to fill missing values at a later point.||Scores on a scale||Standard Error|Least Squares Mean
819569|NCT01138046|Secondary|Drug Clearance (CL) of Paclitaxel|CL is defined as the volume of plasma in the vascular compartment cleared of drug per unit time by the processes of metabolism and excretion. CL was calculated from paclitaxel plasma concentration-time data on Day 1 and Day 8 with model-independent analyses|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Day 1 and Day 8 for paclitaxel|PK Population: all participants who provided blood samples for PK evaluation.||mL/hour/m^2||95% Confidence Interval|Geometric Mean
819570|NCT01138046|Secondary|Half-life (t1/2) of Paclitaxel|Half-life is defined as the time required for the amount of the drug in the plasma to decrease by half. T1/2 was calculated from paclitaxel plasma concentration-time data on Day 1 and Day 8 with model-independent analyses|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Day 1 and Day 8 for paclitaxel|PK Population: all participants who provided blood samples for PK evaluation||Hr||95% Confidence Interval|Geometric Mean
819575|NCT01138046|Secondary|Maximum Plasma Concentration (Cmax) of Lapatinib and Paclitaxel|Cmax is defined as the maximum concentration of lapatinib and paclitaxel. Cmax was calculated from lapatinib plasma concentration-time data on Day 8 and Day 14 and paclitaxel plasma concentration-time data on Day 1 and Day 8 with model-independent analyses|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Day 8 and Day 14 for lapatininb; Day 1 and Day 8 for paclitaxel|Pharmacokinetic (PK) Population: all participants who provided blood samples for PK evaluation||Nanogram per milliliter ng/mL||95% Confidence Interval|Geometric Mean
819576|NCT01138046|Secondary|Number of Participants With Clinical Benefit Response (CBR)|CBR is defined using RECIST as the number of participants who received at least one dose of study medication and achieved a best OR classified as CR, PR or SD for at least 6 months (24 weeks), i.e., CR + PR + SD for >=24 weeks. CBR was based on confirmed responses by the investigator. CR is defined as the disappearance of all TLs and non-TLs. PR is defined as at least a 30% decrease in the sum of the LD of the target lesions, taking as a reference, the Baseline sum LD. Baseline measurements were obtained at the Screening Visit. PD is defined as at least a 20% increase in the sum of the LD of TLs or the appearance of 1 or more new lesions compared to the smallest sum LD recorded since the treatment started. SD is defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD compared to the smallest sum LD since the treatment started. Any participant who could not be classified by the the four preceding definitions was considered Not evaluable|From the start of treatment until progressive disease/death (up to 1009 Days).|All Subjects Population. All participants who received at least one dose of study medication.||Participants|||Number
819577|NCT01138046|Secondary|Number of Partcipants With a Best Overall Response (OR) as Determined by the Response Evaluation Criteria in Solid Tumors (RECIST)|Best OR was defined as the best response recorded from the start of treatment until progressive disease (PD)/death as assessed by the investigator. CR is defined as the disappearance of all TLs and non-TLs. PR is defined as at least a 30% decrease in the sum of the LD of the target lesions, taking as a reference, the Baseline sum LD. Baseline measurements were obtained at the Screening Visit. PD is defined as at least a 20% increase in the sum of the LD of target lesions or the appearance of 1 or more new lesions compared to the smallest sum LD recorded since the treatment started. Stable disease (SD) is defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD compared to the smallest sum LD since the treatment started. Any participant who could not be classified by the four preceding definitions was considered Not evaluable.|From the start of treatment until progressive disease/death (up to 1009 Days).|All Subjects Population. All participants who received at least one dose of study medication.||Participants|||Number
819578|NCT01138046|Secondary|Duration of Response|Duration of response is defined as the time from the first documented evidence of a CR or a PR until the first documented sign of disease progression or death due to any cause (whichever occured earlier). The analysis was based on responses as evaluated by the investigator and was confirmed at a repeat assessment, with the duration of response taken from the first time the response was observed. CR is defined as the disappearance of all TLs and non-TLs. PR is defined as at least a 30% decrease in the sum of the LD of the target lesions, taking as a reference, the Baseline sum LD. Baseline measurements were obtained at the Screening Visit.|From the first documented evidence of a CR or a PR until the first documented sign of disease progression or death, whichever occurred earlier (up to 953 Days).|All Subjects Population. Only those participants with a CR or a PR were assessed. For participants who did not progress or die, duration of response was censored on the date of the last assessment.||Months||95% Confidence Interval|Median
819579|NCT01138046|Secondary|Time to Response|Time to response is defined as the time from the start of treatment until first documented evidence of partial response (PR) or a complete response (CR) (whichever status is recorded first). Analysis was based on responses confirmed at a repeat assessment made at least 4 weeks after the initial response, with the time to response taken as the first time the response was observed. CR is defined as the disappearance of all target lesions (TLs) and non-TLs. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of the target lesions, taking as a reference, the Baseline sum LD. Baseline measurements were obtained at the Screening Visit.|From the start of treatment until the first documented evidence of a PR or CR, whichever status is recorded first (up to 66 Days).|All Subjects Population. Only those participants with a CR or a PR were assessed.||Months||95% Confidence Interval|Median
819580|NCT01138046|Secondary|Progression-free Survival (PFS)|PFS is defined as the interval between the start of treatment and the earliest date of radiological disease progression or death due to any cause, whichever occurred first. PFS was based on the investigator's assessment. For participants who survived, time to death was censored at the time of the last confirmation of survival.|From the start of treatment until the earliest date of radiological disease progression or death due to any cause, whichever occured first (up to 1009 Days).|All Subjects Population. Participants who met the following criteria were censored: no Baseline assessment, no progression, treatment discontinuation for undocumented progression, treatment discontinuation for toxicity or other reason, new anti-cancer treatment started, and death or progression after more than one missed visit.||Months||95% Confidence Interval|Median
819581|NCT01138046|Primary|Overall Survival|Overall survival is defined as the time from the start of treatment until death due to any cause. For participants who survived, time to death was censored at the time of the last confirmation of survival.|From the start of treatment until death due to any cause or study close, whichever occurred first (assessed up to a maximum of 1290 Days)|All Subjects Population: all participants who received at least one dose of study medication||Months||95% Confidence Interval|Median
819582|NCT01138046|Primary|Number of Participants With Intolerable Toxicities in Phase I of the Study|Investigational treatment was considered tolerable if one or more of the tolerability criteria were met by none or one of the 6 participants in the first cycle of Phase I. If one or more tolerability criteria were met by two or more participants, the issue was referred to the safety committee. Tolerability criteria for toxicities related to investigational treatment included grade 4 neutropenia persisting for 7 or more days, thrombocytopenia with a platelet count of less than or equal to 25,000/millimeter (mm)^3 , clinically significant Grade 3 or 4 non-haematologic toxicities (excluding nausea) and inability to start cycle 2 within 2 weeks of scheduled dosing due to unresolved toxicity.|28 days|All Subjects Population: all participants who received at least one dose of study medication and participated in Phase I of the study.||Participants|||Number
819709|NCT01130597|Secondary|Mean Dose of Patiromer at End of Treatment||56 Days|||grams||Standard Deviation|Mean
819584|NCT01138098|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31-day (Days 0-30) follow-up period after a challenge dose of Engerix™-B vaccine|The Total Vaccinated cohort included all subjects who received the challenge dose of Engerix-B vaccine.||Subjects|||Number
819585|NCT01138098|Secondary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed were fatigue, gastrointestinal, headache and temperature (Temperature is defined as axillary temparature equal to or above 37.5 degrees Celsius (°C)).|During the 4-day (Days 0-3) follow-up period after a challenge dose of Engerix™-B vaccine|The Total Vaccinated cohort included all subjects who received the challenge dose of Engerix-B vaccine.||Subjects|||Number
819586|NCT01138098|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling.|During the 4-day (Days 0-3) follow-up period after a challenge dose of Engerix™-B vaccine|The Total Vaccinated cohort included all subjects who received the challenge dose of Engerix-B vaccine.||Subjects|||Number
819587|NCT01138098|Secondary|Number of Subjects With Anti-HBs Antibody Concentration ≥ 100 mIU/mL|A seroprotected subject was defined as a subject with anti-HBs antibody concentration ≥ 10 mIU/mL. A decrease in the specificity of the anti-HB ELISA had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis.|Before the challenge dose of Engerix™-B vaccine|The According-To-Protocol (ATP) cohort for analysis of immunogenicity included all evaluable subjects (i.e. those meeting eligibility criteria, complied with the procedures, with no elimination criteria) who had received a challenge dose Engerix-B vaccine and for whom immunogenicity data were available at the post-Engerix-B challenge time-point.||Subjects|||Number
819588|NCT01138098|Secondary|Number of Subjects With Anti-HBs Antibody Concentration ≥ 10 mIU/mL|A seroprotected subject was defined as a subject with anti-HBs antibody concentration ≥ 10 mIU/mL. A decrease in the specificity of the anti-HB enzyme-linked immunosorbent assay (ELISA) had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis.|Before and one month after a challenge dose of Engerix™-B vaccine|The According-To-Protocol (ATP) cohort for analysis of immunogenicity included all evaluable subjects (i.e. those meeting eligibility criteria, complied with the procedures, with no elimination criteria) who had received a challenge dose Engerix-B vaccine and for whom immunogenicity data were available at the post-Engerix-B challenge time-point.||Subjects|||Number
819589|NCT01138098|Secondary|Number of Subjects With Anti-HBs Antibody Concentration ≥ 6.2 mIU/mL|A seropositive subject was defined as a subject with anti-HBs antibody concentration ≥ the 6.2 mIU/mLcut-off. A decrease in the specificity of the anti-HB ELISA had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis and the initial 3.3 mIU/mL seropositivity cut-off was revised into the new 6.2 mIU/mL cut-off.|Before and one month after a challenge dose of Engerix™-B vaccine|The According-To-Protocol (ATP) cohort for analysis of immunogenicity included all evaluable subjects (i.e. those meeting eligibility criteria, complied with the procedures, with no elimination criteria) who had received a challenge dose Engerix-B vaccine and for whom immunogenicity data were available at the post-Engerix-B challenge time-point.||Subjects|||Number
819590|NCT01138098|Secondary|Number of Subjects With an Anamnestic Response to a Challenge Dose|The anamnestic response was defined as: at least (≥) a 4-fold rise in post-challenge dose anti-HBs antibody concentrations in subjects seropositive at the pre-challenge dose time point. - Post-challenge dose anti-HBs antibody concentrations ≥ 10 mIU/mL in seronegative subjects at the pre-challenge dose time point. A seropositive/seronegative subject is a subject with anti-HBs antibody concentration ≥/lower than (<) 6.2 mIU/mL. A decrease in the specificity of the anti-HB ELISA had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis and the initial 3.3 mIU/mL seropositivity cut-off was revised into the new 6.2 mIU/mL cut-off.|Before and one month after a challenge dose of Engerix™-B vaccine|The According-To-Protocol (ATP) cohort for analysis of immunogenicity included all evaluable subjects (i.e. those meeting eligibility criteria, complied with the procedures, with no elimination criteria) who had received a challenge dose Engerix-B vaccine and for whom immunogenicity data were available at the post-Engerix-B challenge time-point.||Subjects|||Number
819591|NCT01138098|Primary|Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 100 Milli-International Units Per Milliliter (mIU/mL)|A decrease in the specificity of the anti-HB enzyme-linked immunosorbent assay (ELISA) had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis.|One month after a challenge dose of Engerix™-B vaccine|The According-To-Protocol (ATP) cohort for analysis of immunogenicity included all evaluable subjects (i.e. those meeting eligibility criteria, complied with the procedures, with no elimination criteria) who had received a challenge dose Engerix-B vaccine and for whom immunogenicity data were available at the post-Engerix-B challenge time-point.||Subjects|||Number
819612|NCT01129206|Secondary|Correlation of FDG PET Response With Response Rate|Radiological assessment of tumor response was performed by computed tomography (CT) and positron emission tomography (PET) every four cycles of therapy and responses were measured according to RECIST and PERCIST criteria.|Approximately three years|2 patients not evaluable for response applying the PERCIST criteria per PET||patients|||Number
819592|NCT01138111|Secondary|Sensitivity/Specificity/Negative Predictive Value (NPV)/Positive Predictive Value (PPV) at Baseline, 12, and 24 Months in the Detection of Significant Brain ß-amyloid Plaque Load in Patients With MCI Progressing to AD Compared to Those Who do Not Progress|"Sensitivity, specificity, NPV and PPV were measured based on subject BAPL scores by time point and imaging window, compared to clinical diagnosis of AD during the study period. A BAPL score of 1 was considered negative for the presence of beta-amyloid, and scores of 2 and 3 were considered positive.
For this study, sensitivity was defined as the percentage of subjects with a clinical diagnosis of AD who also had a positive PET scan (BAPL score of 2 or 3) at the respective time point.
Specificity was defined as the percentage of subjects with a clinical diagnosis of non-AD who also had a negative PET scan (BAPL score of 0 or 1) at the respective time point.
PPV was defined as the probability that a subject with a positive PET scan would have a clinical diagnosis of AD sometime during the 2 year follow up period.
NPV was defined as the probability that a subject with a negative PET scan would not have a clinical diagnosis of AD at any point during the 2 year follow up period."|2 scanning periods post injection to be evaluated at baseline|All subjects with PET data at the referenced study time point||percentage of subjects|||Number
819593|NCT01138111|Secondary|Number and Proportion of Normal and Abnormal Scans Based on Brain ß-amyloid Plaque Load (BAPL) in Subjects With MCI Converting to AD and Those Who do Not Progress|At each study time point (baseline, 12 months and 24 months) PET images were obtained at 45 min and again at 90 post injection. These images were assigned a BAPL score of 1, 2 or 3 based on the reader’s evaluation of the scan. A BAPL scores of 1 was considered normal, and scores of 2 and 3 were considered abnormal. These scores were compared to subjects clinical diagnosis for AD at the end of the study follow up period.|2 scanning periods post injection to be evaluated each at baseline, at 12 months, and at 24 months|All subjects with PET data at the referenced study time point||participants|||Number
819594|NCT01138111|Secondary|Number of Normal and Abnormal Scans in Patients With MCI Progressing to AD and Those Who do Not Progress Based on a Threshold of Neocortical SUVR=1.4|This outcome measure showed the number of abnormal scans in subjects with MCI progressing to AD and those who did not progress compared to subjects with normal scans that did not progress and those who did progress.|1 scanning period post injection to be evaluated at baseline, at 12 months and at 24 months|All subjects receiving study drug||participants|||Number
819595|NCT01138111|Primary|Quantitative Assessment of Neocortical SUVRs (Mean Standard Uptake Value Ratios) as a Measure of Florbetaben Uptake|Mean SUVRs were calculated for subjects who did and did not progress to Alzheimer's Disease (AD) during the study for each PET scan time point (baseline, 12 and 24 months)|1 scanning period post injection to be evaluated at baseline, 12 months and 24 months|All subjects receiving study drug with PET scan data at the respective timepoint||SUVR||Standard Deviation|Mean
819596|NCT01138124|Primary|Number of Renal Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin|Incident renal cancer. Gabapentin Exposure Description: Without 2 year lag = Gabapentin exposure from cohort entry to index date. With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Tertile’s without 2 year lag: Tertile 1 (0.01 - 33.6 grams), Tertile 2 (33.7 - 185.0 grams), and Tertile 3 (185.1 - 7500.2 grams). Tertile’s with 2 year lag: Tertile 1 (0.01 - 39.0 grams), Tertile 2 (39.1 - 210.0 grams), and Tertile 3 (210.1 - 5623.8 grams).|The case index date (ID) was the date of incident renal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control ID was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases and controls were drawn from the GPRD study cohort. Entry into the study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Follow-up ended Dec 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death.||participants|||Number
819597|NCT01138124|Primary|Number of Renal Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin|Incident renal cancer. Gabapentin Exposure Description: Without 2 year lag = Gabapentin exposure from cohort entry to index date. With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Tertile’s without 2 year lag: Tertile 1 (0.01 - 1.55 months), Tertile 2 (1.56 - 6.44 months), and Tertile 3 (6.45 - 78.36 months). Tertile’s with 2 year lag: Tertile 1 (0.01 - 1.78 months), Tertile 2 (1.79 - 7.20 months), and Tertile 3 (7.21 - 64.13 months).|The case index date (ID) was the date of incident renal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control ID was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases and controls were drawn from the GPRD study cohort. Entry into the study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Follow-up ended Dec 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death.||participants|||Number
819598|NCT01138124|Primary|Number of Renal Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions|Incident renal cancer. Gabapentin Exposure Description: Without 2 year lag = Gabapentin exposure from cohort entry to index date. With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Tertiles without 2 year lag: Tertile 1 (1-2 prescriptions),Tertile 2 (3-8 prescriptions), and Tertile 3 (9-218 prescriptions). Tertile’s with 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-10 prescriptions),Tertile 3 (11-191 prescriptions).|The case index date (ID) was the date of incident renal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control ID was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases and controls were drawn from the GPRD study cohort. Entry into the study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Follow-up ended Dec 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death.||participants|||Number
819613|NCT01129206|Secondary|Overall Survival (OS)|OS was determined from the date of start of therapy to death frm any cause.|Approximately five years|||months||95% Confidence Interval|Median
819614|NCT01129206|Secondary|Progression-free Survival (PFS)|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Approximately three years|||months||95% Confidence Interval|Median
819599|NCT01138124|Primary|Number of Renal Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin|Incident renal cancer. Gabapentin Exposure Description: Without 2 year lag = Gabapentin prescription from cohort entry to index date. With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer).|The case index date (ID) was the date of incident renal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control ID was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases and controls were drawn from the GPRD study cohort. Entry into the study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Follow-up ended Dec 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death.||participants|||Number
819600|NCT01138124|Primary|Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin|Incident pancreatic cancer. Gabapentin Exposure Description: Without 2 year lag = Gabapentin exposure from cohort entry to index date. With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Tertile’s without 2 year lag: Tertile 1 (0.01 - 33.6 grams), Tertile 2 (33.7 - 185.0 grams), and Tertile 3 (185.1 - 7500.2 grams). Tertile’s with 2 year lag: Tertile 1 (0.01 - 39.0 grams), Tertile 2 (39.1 - 210.0 grams), and Tertile 3 (210.1 - 5623.8 grams).|The case index date (ID) was the date of incident pancreatic cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control ID was the date at which the follow-up time from his/her cohort entry was the same as that for the case|Cases and controls were drawn from the GPRD study cohort. Entry into the study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Follow-up ended Dec 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death.||participants|||Number
819601|NCT01138124|Primary|Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin|Incident pancreatic cancer. Gabapentin Exposure Description: Without 2 year lag = Gabapentin exposure from cohort entry to index date. With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Tertile’s without 2 year lag: Tertile 1 (0.01 - 1.55 months), Tertile 2 (1.56 - 6.44 months), and Tertile 3 (6.45 - 78.36 months). Tertile’s with 2 year lag: Tertile 1 (0.01 - 1.78 months), Tertile 2 (1.79 - 7.20 months), and Tertile 3 (7.21 - 64.13 months).|The case index date (ID) was the date of incident pancreatic cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control ID was the date at which the follow-up time from his/her cohort entry was the same as that for the case|Cases and controls were drawn from the GPRD study cohort. Entry into the study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Follow-up ended Dec 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death.||participants|||Number
819602|NCT01138124|Primary|Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions|Incident pancreatic cancer. Gabapentin Exposure Description: Without 2 year lag = Gabapentin exposure from cohort entry to index date. With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Tertiles without 2 year lag: Tertile 1 (1-2 prescriptions),Tertile 2 (3-8 prescriptions), and Tertile 3 (9-218 prescriptions). Tertile’s with 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-10 prescriptions),Tertile 3 (11-191 prescriptions).|The case index date (ID) was the date of incident pancreatic cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control ID was the date at which the follow-up time from his/her cohort entry was the same as that for the case|Cases and controls were drawn from the GPRD study cohort. Entry into the study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Follow-up ended Dec 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death.||participants|||Number
819603|NCT01138124|Primary|Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin|Incident pancreatic cancer. Gabapentin Exposure Description: Without 2 year lag = Gabapentin prescription from cohort entry to index date. With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer).|The case index date (ID) was the date of incident pancreatic cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control ID was the date at which the follow-up time from his/her cohort entry was the same as that for the case|Cases and controls were drawn from the GPRD study cohort. Entry into the study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Follow-up ended Dec 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death.||participants|||Number
819604|NCT01138150|Secondary|Resistin|serum resistin levels after treatment in responders and non responders|30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment|||ug/mL||95% Confidence Interval|Mean
819605|NCT01138150|Secondary|Leptin|serum leptin levels after treatment in responders and non responders|30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment|||ug/mL||95% Confidence Interval|Mean
819606|NCT01138150|Secondary|Low Molecular Weight (LMW):Total (T)-ADP|serum LMW:T-ADP levels after treatment in responders and non responders|30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment|||ratio||95% Confidence Interval|Mean
819607|NCT01138150|Secondary|High Molecular Weight (HMW): T-ADP|serum HMW:T-ADP levels after treatment in responders and non responders|30 minutes, 60 minutes, 120 minutes after treatment|||ratio||95% Confidence Interval|Mean
819608|NCT01138150|Secondary|Low Molecular Weight (LMW)-ADP|serum LMW-ADP levels after treatment in responders and non responders|30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment|||ug/mL||95% Confidence Interval|Mean
819609|NCT01138150|Secondary|Middle Molecular Weight (MMW)-ADP|serum MMW-ADP levels after treatment in responders and non responders|30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment|||ug/mL||95% Confidence Interval|Mean
819610|NCT01138150|Secondary|High Molecular Weight (HMW)-Adiponectin (ADP)|serum HMW-ADP levels after treatment in responders and non responders|30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment|||ug/mL||95% Confidence Interval|Mean
819615|NCT01129206|Primary|Overall Response|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Approximately three years|||patients|||Number
819618|NCT01129284|Secondary|Sustained Remissions up to 1 Year After Discontinuing Therapy|Complete remission defined as stable or improved renal function, serum creatinine < or = 125% baseline, with proteinuria falling <500 mg/day at last follow-up visit (6 to 12 months post treatment). Partial remission defined as stable or improved renal function, serum creatinine < or = 125% baseline, with 50% reduction in proteinuria and final proteinuria 500-3500 mg/day at last follow-up visit (6 to 12 months post treatment).|Up to 1 year after treatment|||participants|||Number
819619|NCT01129284|Primary|Significant Reduction in Proteinuria to Remission Levels During the Treatment Period (Includes Complete and Partial Remission, as Defined in the Outcome Measure Description Below)|Complete remission is defined as stable or improved renal function, serum creatinine < or = 125% baseline, with proteinuria falling <500 mg/day at month 6. Partial remission is defined as stable or improved renal function, serum creatinine < or = 125% baseline, with 50% reduction in proteinuria and final proteinuria 500-3500 mg/day at month 6.|6 months|||participants|||Number
819620|NCT01129336|Secondary|Change From Baseline in Urine NTX by Month|NTX= N-telopeptide of type 1 collagen (nmol bce/mmol [nanomoles of bone collagen equivalents per millimole of creatinine]). Baseline was defined as the last predose measurement for patients who received any study drug and as the later of the screening visit or visit 2 value for patients who did not receive study drug.|Baseline, Month 2, Month 4|All Enrolled Patients population, which included all enrolled patients regardless of whether they received study drug.||nmol bce/mmol||Standard Deviation|Mean
819621|NCT01129336|Secondary|Time to Progression (TTP)|Time to progression is defined as the time from the date of enrollment to the date of first documented disease progression or death due to metastatic breast cancer.|up to 18 months|All Enrolled Patients population, which included all enrolled patients regardless of whether they received study drug.||Days||95% Confidence Interval|Median
819622|NCT01129336|Secondary|Percentage of Patients With Circulating Tumor Cell Levels of at Least 5 Per 7.5 mL of Peripheral Blood by Month|Circulating tumor cells (CTCs) have been associated with poor patient prognosis and outcomes in patients receiving treatment for MBC. CTCs have been evaluated as a potential biomarker for predicting treatment effects and overall survival. Baseline was defined as the last predose measurement for patients who received any study drug and as the later of the screening visit or Visit 2 value for patients who did not receive the study drug. Percentage was calculated as the number of patients with CTC ≥5/7.5 mL against the number of patients with nonmissing CTC values (represented as 'n' in the categories).|Baseline, Month 1, 2, 4, 6, 9 and 18|"All Enrolled Patients population, which included all enrolled patients regardless of whether they received study drug. n in each category represents the number of patients with non-missing CTC values."||Percentage of Participants||95% Confidence Interval|Number
819623|NCT01129336|Primary|Number of Participants With Progression Free Survival (PFS)|Complete Response (CR): disappearance of all target lesions. Any pathological lymph nodes (target or non-target) must have exhibited a reduction in short axis to < 10 mm. Partial Response (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum of diameters. Progressive Disease (PD): at least 20% increase in sum of diameters of target lesions taking as reference the smallest sum on study accompanied by an absolute increase of at least 5 mm or appearance of one or more new lesions. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference smallest sum diameters. PFS is time from enrollment to date of first documented disease progression or death due to any cause. A participant is considered to be censored when data on time to event is missing due to a subject being lost to follow-up or non-occurrence of the outcome event before the completion of the trial.|up to 18 months|All Enrolled Patients population, which included all enrolled patients regardless of whether they received study drug.||Participants|||Number
819624|NCT01129531|Secondary|Change From Baseline in Evoked Pain Score in the Area of Allodynia|Participants were asked to rate the unpleasantness (pain to touch) after 3 brush strokes in the area of allodynia on a 100 point scale where 0=no pain to 100=worst pain imaginable. A negative change from Baseline indicated improvement.|Baseline, Week 12|Modified intent to treat population included all randomized participants who received treatment and had at least 1 post-baseline pain intensity score.||Score on a scale||Standard Deviation|Mean
819625|NCT01129531|Secondary|Change From Baseline in Area of Allodynia|A tracing of the area of allodynia (pain to touch) was made and sent to an independent central reading center for measurement. The area of allodynia was measured in centimeters squared (cm^2) at Baseline and Week 12. A negative change from Baseline indicated improvement.|Baseline, Week 12|Modified intent to treat population included all randomized participants who received treatment and had at least 1 post-baseline pain intensity score.||cm^2||Standard Deviation|Mean
819626|NCT01129531|Secondary|Change From Baseline in Area of Spontaneous Pain|A tracing of the area of spontaneous pain was made and sent to an independent central reading center for measurement. The area of spontaneous pain was measured in centimeters squared (cm^2) at Baseline and Week 12. A negative change from Baseline indicated improvement.|Baseline, Week 12|Modified intent to treat population included all randomized participants who received treatment and had at least 1 post-baseline pain intensity score.||cm^2||Standard Deviation|Mean
819627|NCT01129531|Primary|Change From Baseline in the Average Pain Intensity Score at Week 12|Participants rated the severity of their daily pain in the previous 7 days using a 10 point scale where 0=no pain to 10=pain as bad as you can imagine. A negative change from Baseline indicated improvement.|Baseline, Week 12|Modified intent to treat population included all randomized participants who received treatment and had at least 1 post-baseline pain intensity score.||Score on a scale||Standard Deviation|Mean
819628|NCT01129557|Secondary|Pre- and Post-treatment Serum Aldosterone in Subjects With and Without Aldosterone Breakthrough.|Compares baseline and final (9 month) serum aldosterone for subjects with and without aldosterone breakthrough|Baseline and Final (9 month)|||(ng/dL)||Standard Deviation|Mean
819630|NCT01129557|Secondary|Pre- and Post-treatment 24-hour Urine Sodium in Subjects With and Without Aldosterone Breakthrough.|Compares baseline and final (9 month) 24-hour urine sodium for subjects with and without aldosterone breakthrough|Baseline and Final (9 month)|||(mmol/day)||Standard Deviation|Mean
819631|NCT01129557|Secondary|Pre- and Post-treatment 24-hour Urine Protein in Subjects With and Without Aldosterone Breakthrough.|Compares baseline and final (9 month) 24-hour urine protein for subjects with and without aldosterone breakthrough|Baseline and Final (9 month)|||(mg/day)||Standard Deviation|Mean
819632|NCT01129557|Secondary|Pre- and Post-treatment Serum Potassium in Subjects With and Without Aldosterone Breakthrough.|Compares baseline and final (9 month) serum potassium for subjects with and without aldosterone breakthrough|Baseline and Final (9 month)|||(mmol/L)||Standard Deviation|Mean
819633|NCT01129557|Secondary|Pre- and Post-treatment Serum Creatinine in Subjects With and Without Aldosterone Breakthrough.|Compares baseline and final (9 month) serum creatinine for subjects with and without aldosterone breakthrough|Baseline and Final (9 month)|||mg/dL||Standard Deviation|Mean
819634|NCT01129557|Secondary|Pre- and Post-treatment Blood Pressure in Subjects With and Without Aldosterone Breakthrough.|Compares baseline and final (9 month) blood pressure for subjects with and without aldosterone breakthrough|Baseline and Final (9 month)|||mm Hg||Standard Deviation|Mean
819635|NCT01129557|Secondary|Mean 24-hour Urine Sodium Over Time During 9-month Treatment Course in Subjects With and Without Aldosterone Breakthrough.|Mean 24-hour urine sodium (mmol/day) at baseline, 3-, 6-, and 9-months. (given as reference to interpret contemporaneous plasma & urine aldosterone measurements.)|Baseline, 3-, 6-, and 9-months|||mmol/day||Standard Deviation|Mean
819636|NCT01129557|Secondary|Serum Potassium Over Time During 9-month Treatment Course in Subjects With and Without Aldosterone Breakthrough.|Mean serum potassium at baseline, 3-, 6-, and 9-months. (given as reference to interpret contemporaneous plasma & urine aldosterone measurements.)|Baseline, 3-, 6-, and 9-months|||mmol/L||Standard Deviation|Mean
819637|NCT01129557|Secondary|Urine Aldosterone Over Time During 9-month Treatment Course in Subjects With and Without Aldosterone Breakthrough.|Mean urine aldosterone at baseline, 3-, 6-, and 9-months.|Baseline, 3-, 6-, and 9-months|||ug/day||Standard Deviation|Mean
819638|NCT01129557|Secondary|Serum Aldosterone Over Time During 9-month Treatment Course in Subjects With and Without Aldosterone Breakthrough.|Mean serum aldosterone at baseline, 3-, 6-, and 9-months.|Baseline, 3-, 6-, and 9-months|||ng/dL||Standard Deviation|Mean
819639|NCT01129557|Primary|Cumulative Incidence of Aldosterone Breakthrough in Subjects Who Completed the 9-month Study Protocol.|The primary outcome of this study is the 9-month cumulative incidence of aldosterone breakthrough, defined as a sustained increase in 24-hour urine aldosterone above baseline, in each treatment arm.|9 months|||participants|||Number
819640|NCT01129583|Secondary|Broberg Morrey Composite Elbow Function Score|Composite elbow function store that takes into account range of motion, stability, strength, and pain. Score ranges from 0 (worse possible function) to 100 (best possible function).|6 months post-op|||Score||Standard Error|Mean
819641|NCT01129583|Secondary|Elbow Range of Motion|Elbow flexion/extension active range of motion was assessed with the use of a standard goniometer with the center placed over the lateral epicondyle and the arms aligned with the long axis of the humerus and ulna, respectively. Full extension (arm completely straight) is defined as 0 degrees, and peak flexion is measured as the angle formed by the arm and forearm compared to a full straight arm.|3 months post-op|||Degrees||Standard Error|Mean
819642|NCT01129583|Primary|Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire|"The Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure is a questionnaire designed to measure physical function and symptoms in patients with musculoskeletal disorders of the upper limb.
The DASH is scored in two components: the disability/symptom questions (30 items, scored 1-5) and the optional high performance sport/music or work section (4 items, scored 1-5). The DASH disability/symptom score (0-100) is calculated by averaging all the scores, subtracting one and multiplying by 25. A score of 0 represents no disability, while 100 represents maximum possible disability."|1 year post-op|||Scores on a Scale (0-100)||Standard Error|Mean
819643|NCT01129622|Secondary|Number of Participants Developed Adverse Effects of 12.5 mg of Letrozole|The number of participants who developed short term hypoestrogenic side effects or other adverse effects of letrozole during the intake of the medication or in the following week.|Three days plus One Week following medication|All entered subjects||Number of participants|||Number
819644|NCT01129622|Primary|Number of Women With Reduced Breast Parenchymal Enhancement|Image analysis was done using the e-film workstation. A region of interest was selected in all images. The signal intensity of enhancement was recorded and the relative enhancement (percentage of increase in signal intensity) was calculated as (SIc − SI)/SI × 100, where SI and SIc are the precontrast and the postcontrast signal intensities, respectively. Relative enhancement was compared at the baseline MRI study and the after one month MRI study for all participants.|One month MRI study after letrozole compared to baseline MRI study, both with gadolinium enhancement|All participants who completed two MRIs were analysed. Percentage reduction in breast enhancement compared to baseline was determined.||Number of participants|||Number
819645|NCT01129765|Secondary|Number of Patients Experiencing a Physical Injury During Use|"After the procedure, the patient was directly examined for any of the following:
bleeding from the nostrils
disruption of the skin around the nose
increased work of breathing/respiratory distress (increased respiratory rate, increased respiratory accessory muscle use)"|Day one, immediately|This is the total number of participants, all of whose children were examined after the procedure.||paricipants|||Number
819646|NCT01129765|Secondary|Number of Patients Who Were Observed to Have an Adverse Event|"While using the device, the patients were observed by the research coordinator for any of the following adverse events to occur:
bloody nose
being sprayed in the eye with the saline
vomiting after the procedure
choking during or after the procedure
other"|Day one, immediately|||patients with an adverse event|||Number
819647|NCT01129765|Secondary|Number of Participants Who Identified the Device's User Manual as Easy to Understand|"After using the device, the caregiver answered this question on a five point Likert-like scale with increasing favorability with increasing number. The proportion answering 3 or greater is reported along with the exact 95% confidence intervals.
The question and scale are as follows: How easy was the manual to understand?
1 difficult, 2 somewhat hard, 3 fairly easy, 4 easy, 5 very easy"|Day one, immediately|||participants|||Number
819710|NCT01130597|Secondary|Percentage of Participants With Serum Potassium in the Range of 4.0 – 5.1 mEq/L at the End of Treatment||56 Days|||percentage of participants|||Number
819648|NCT01129765|Primary|Number of Participants Who Properly Used the Nasal Irrigator/Aspirator Device|"'Proper use' is defined as successfully completing all of the following five steps:
Attaching wash-head to handle properly
Positioning child correctly for procedure as per the user manual's instructions
Using the device's control button correctly for both irrigation and aspiration
Placing the wash-head tip correctly at the nasal opening
Using the device for up to but not exceeding five seconds"|Day one, immediately|||participants|||Number
819649|NCT01129765|Secondary|Number of Participants Who Found the Device to be Effective|"After using the device, the caregiver answered this question on a five point Likert-like scale with increasing favorability with increasing number. The proportion answering 3 or greater is reported along with the exact 95% confidence intervals.
The question and scale are as follows: How well did the device remove nasal secretions?
1 difficult, 2 somewhat hard, 3 fairly easy, 4 easy, 5 very easy"|Day one, immediately|||participants|||Number
819650|NCT01129765|Secondary|Number of Participants Who Experienced Ease of Use With the Device|"After using the device, the caregiver answered this question on a five point Likert-like scale with increasing favorability with increasing number. An answer of 3 or greater is considered an affirmative answer. Such responses reported along with the exact 95% confidence intervals.
The question and scale are as follows: How easy was the device to use?
1 difficult, 2 somewhat hard, 3 fairly easy, 4 easy, 5 very easy"|Day one, immediately|This was the total number of participants who answered this question.||participants|||Number
819651|NCT01129778|Secondary|Reflux Disease Questionnaire Score on Day 1 After Therapy Completion|The RDQ is a 12 item survey that asks the patient to rate the frequency and severity of GERD symptoms. Each item is scored from 0 to 5 where a score of 0 is equivalent to an asymptomatic state and 5 indicates the worst severity of GERD symptoms. The total RDQ is a sum of all 12 items, and can range from 0 to 60.|Day 1 after therapy period completion|Participants who completed all protocol-specified assessments were included in the analysis.||Units on a scale||Standard Deviation|Mean
819652|NCT01129778|Primary|Percentage of Time Esophageal pH< 4|Reported as the the average percentage over 24 hours of total time, upright time, and supine time per day with pH <4 (symptomatic acid state) as evaluated with the Bravo pH monitoring technique.|Days 1 and 2|Participants who completed all protocol-specified assessments were included in the analysis.||percentage of hours||Standard Deviation|Mean
819653|NCT01129921|Primary|Visual Analog Scale (VAS) Mean Improvement|VAS ten point scale where 0 = no pain and 10 represents worst pain imaginable. Mean improvement of two or more points is considered clinically relevant. The mean improvement from Baseline to Year-1 is presented below for the two treatment groups.|Baseline and Year 1|All patients who reported Year-1 outcomes (Year-1 Cohort) were analyzed. The Sham Year-1 cohort represent those original Sham patients who crossed over from Sham to the mild procedure and were then followed for one year.||units on a scale||Standard Deviation|Mean
819654|NCT01129921|Primary|Visual Analog Scale (VAS) <=4|"VAS as measured on a 10-point scale. A score of 4 or less after treatment is considered favorable, as it indicates pain is less than the moderate to severe categories represented by scores of 5 to 10. All patients in each arm who reported a pain score of 4 or less at Week 6-12 and Year 1 are reported below."|Week 6 to 12 & Year One After Sham to mild x-over|Patients who reported Year 1 outcomes are reported at Week 6-12 and at Year 1. All findings reported below for the Sham group are after cross-over to mild.||participants|||Number
819655|NCT01129921|Primary|Visual Analog Scale (VAS) <=4|Using VAS, pain is measured on a 0 to 10 point scale where 0 represents no pain and 10 indicates severe pain. A post-treatment score of 4 points is the accepted threshold between a “mild” pain score of 1-3 points and a “moderate to severe” pain score of 5 to 10 points which represents debilitating pain that would qualify the patient for a different or additional treatment option. All patients in each arm who reported a pain score of 4 or less at six to twelve weeks post-treatment are reported below.|Week 6 to 12 prior to cross-over|All 40 participants (20 in each arm) reported VAS at six weeks to twelve weeks post-treatment. All measurements for the sham group occurred prior to cross-over to the mild procedure. Patients with scores of 4 or less in each study group are reported below. This is Intent to Treat (ITT)analysis.||participants|||Number
819656|NCT01129960|Primary|Change From Baseline to Endpoint in Mean Pain|Study was prematurely halted. The efficacy analysis was restricted to the primary efficacy variable in the interim analysis population. The intended treatment period, starting on the day of the randomization and ending at the efficacy cut-off date (31st October 2011), was the basis for the efficacy analysis; patients with less than 20 days of study medication were excluded from the analysis, except those with early discontinuation. Primary efficacy variable was the difference between the mean values of 7 daily pain scores preceding the efficacy cut-off date (endpoint mean pain score), and before randomization (baseline mean pain score), respectively. The daily pain scores were based on the morning response to the 11-point Numeric Rating Pain Scale (NRPS) question relating to average pain intensity over the last 24 hours. The NPRS is an 11-point scale from 0-10 [“0” = no pain; “10” = the most intense pain imaginable]|baseline up to endpoint 15 weeks (3-week titration phase and 12-week treatment maintenance phase)|FAS = Full Analysis Set (comprised all randomized subjects with mean pain score at baseline and mean score after randomization; subjects with less than 20 days of study medication of the cut-off date were excluded from the dataset, except those that prematurely withdrew; this was the primary population used in the efficacy analysis)||units on a scale||Standard Error|Least Squares Mean
819657|NCT01130051|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. AUC (0-∞) was calculated as the sum of AUC (0-t) plus the ratio of the last measurable Colcrys® plasma concentration to the elimination rate constant.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.25, 0.5, 1.0, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 18, 20, 24, 36, and 48 hours after drug administration|Plasma concentration data for 13 of 16 participants were used in the statistical analysis. One subject dropped from the study before Period 2 dosing for personal reasons. Two subjects were discontinued from the study before Period 2 for protocol violations.||ng-hr/mL||Standard Deviation|Mean
819711|NCT01130597|Secondary|Percentage of Participants With Serum Potassium in the Range of 4.0 – 5.1 mEq/L at Week 8||56 Days|Participants with available data at Week 8.||percentage of participants|||Number
819712|NCT01130597|Secondary|Percentage of Participants With Serum Potassium in the Range of 4.0 – 5.1 mEq/L at Week 4||28 Days|Participants with available data at Week 4.||percentage of participants|||Number
819658|NCT01130051|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable Colcrys® concentration (t), as calculated by the linear trapezoidal rule|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.25, 0.5, 1.0, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 18, 20, 24, 36, and 48 hours after drug administration|Plasma concentration data for 13 of 16 participants were used in the statistical analysis. One subject dropped from the study before Period 2 dosing for personal reasons. Two subjects were discontinued from the study before Period 2 for protocol violations.||ng-hr/mL||Standard Deviation|Mean
819659|NCT01130051|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that Colcrys® reaches in the plasma|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.25, 0.5, 1.0, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 18, 20, 24, 36, and 48 hours after drug administration|Plasma concentration data for 13 of 16 participants were used in the statistical analysis. One subject dropped from the study before Period 2 dosing for personal reasons. Two subjects were discontinued from the study before Period 2 for protocol violations.||ng/mL||Standard Deviation|Mean
819660|NCT01130103|Primary|Number of Participants Who Met Remission Criterion|remission defined as: CAPS less than or equal to 20 and Clinical Global Impression (CGI)-change score=1|Weeks 5,10|all participants who were randomized, with people who dropped out counted as non-remitters||participants|||Number
819661|NCT01130103|Secondary|Quality of Life Enjoyment and Satisfaction Scale Total Score at Week 0,5,10|Measures life enjoyment and satisfaction across 16 domains 16 = very poor quality of life to 80 =very good quality of life|weeks 0,5,10|observed data at weeks 0, 5, and 10||units on a scale||Standard Deviation|Mean
819662|NCT01130103|Secondary|Hamilton Depression Scale 0 = no Depression Symptoms 40 = Extreme Depression Symptoms|total score at weeks 0, 5, 10|weeks 0,5,10|observed data at each time point||units on a scale||Standard Deviation|Mean
819663|NCT01130103|Secondary|Treatment Response at Weeks 5 and 10|"responder status: CGI-change score of 1 or 2
1=very much improved, 2= much improved"|weeks 5,10|all subjects randomized with dropouts carried forward as nonresponders||participants|||Number
819664|NCT01130103|Primary|Clinician Administered PTSD Scale (CAPS)|PTSD severity, minimum = 0 = no symptoms of PTSD maximum = 136 = extremely severe symptoms of PTSD|Weeks 0,5,10|all participants who were randomized||units on a scale||Standard Deviation|Mean
819665|NCT01130168|Primary|Change From Baseline (0 Hours) to Week 4 in Peripheral DBP After Multiple Doses of Treatment|Peripheral SBP was measured by Brachial Sphygmomanometer (standard cuff). Peripheral DBP was measured at baseline and at 24 hours post dose on Day 28 (Week 4) and expressed as a change from baseline.|Baseline (0 hrs), 24 hours after the Day 28 dose|33 participants completed all study periods and provided more than 1 period of BP data, and were thus evaluable for the BP analyses.||mm mercury (Hg)||Standard Deviation|Least Squares Mean
819666|NCT01130168|Primary|TWA Change From Baseline (0 Hours) to 12 Hours in Peripheral DBP After A Single Dose of Treatment|Peripheral DBP was measured by Brachial Sphygmomanometer (standard cuff). Single dose effects on peripheral DBP were estimated as a time-weighted average change from baseline over the 12-hour post single dose observation period.|Baseline (0 hrs), 12 hours post-dose (Day 1)|33 participants completed all study periods and provided more than 1 period of BP data, and were thus evaluable for the BP analyses.||mm mercury (Hg)||Standard Deviation|Least Squares Mean
819667|NCT01130168|Primary|Change From Baseline (0 Hours) to Week 4 in Peripheral SBP After Multiple Doses of Treatment|Peripheral SBP was measured by Brachial Sphygmomanometer (standard cuff). Peripheral SBP was measured at baseline and at 24 hours post dose on Day 28 (Week 4) and expressed as a change from baseline.|Baseline (0 hrs), 24 hours after the Day 28 dose|33 participants completed all study periods and provided more than 1 period of BP data, and were thus evaluable for the BP analyses.||mm mercury (Hg)||Standard Deviation|Least Squares Mean
819668|NCT01130168|Primary|TWA Change From Baseline (0 Hours) to 12 Hours in Peripheral SBP After A Single Dose of Treatment|Peripheral SBP was measured by Brachial Sphygmomanometer (standard cuff). Single dose effects on peripheral SBP were estimated as a time-weighted average change from baseline over the 12-hour post single dose observation period.|Baseline (0 hrs), 12 hours post-dose (Day 1)|33 participants completed all study periods and provided more than 1 period of BP data, and were thus evaluable for the BP analyses.||mm mercury (Hg)||Standard Deviation|Least Squares Mean
819669|NCT01130168|Primary|Change From Baseline (0 Hours) to Week 4 in Central DBP After Multiple Doses of Treatment|Central DBP was measured by the SphygmoCor® device. Central DBP was measured at baseline and at 24 hours post dose on Day 28 (Week 4) and expressed as a change from baseline.|Baseline (0 hrs), 24 hours after the Day 28 dose|"33 participants completed all study periods and provided more than 1 period of BP data, and were thus evaluable for the BP analyses.
Unreliable SphygmoCor® data were collected for one participant in the ISM ER treatment group, therefore this participant was excluded from the multiple dose DBP analysis."||mm mercury (Hg)||Standard Deviation|Least Squares Mean
819670|NCT01130168|Primary|TWA Change From Baseline (0 Hours) to 12 Hours in Central Diastolic Blood Pressure (DBP) After A Single Dose of Treatment|Central DBP was measured by the SphygmoCor® device. Single dose effects on central DBP were estimated as a time-weighted average change from baseline over the 12-hour post single dose observation period.|Baseline (0 hrs), 12 hours post-dose (Day 1)|"33 participants completed all study periods and provided more than 1 period of BP data, and were thus evaluable for the BP analyses.
Unreliable SphygmoCor® data were collected for one participant in the ISM ER treatment group, therefore this participant was excluded from the single dose DBP analysis."||mm mercury (Hg)||Standard Deviation|Least Squares Mean
819671|NCT01130168|Primary|Change From Baseline (0 Hours) to Week 4 in Central SBP After Multiple Doses of Treatment|Central SBP was measured by the SphygmoCor® device. Central SBP was measured at baseline and at 24 hours post dose on Day 28 (Week 4) and expressed as a change from baseline.|Baseline (0 hrs), 24 hours after the Day 28 dose|"33 participants completed all study periods and provided more than 1 period of BP data, and were thus evaluable for the BP analyses.
Unreliable SphygmoCor® data were collected for one participant in the ISM ER treatment group, therefore this participant was excluded from the multiple dose SBP analysis."||mm mercury (Hg)||Standard Deviation|Least Squares Mean
819713|NCT01130597|Secondary|Percentage of Participants With Serum Potassium in the Range of 3.5 – 5.5 mEq/L at Week 8||56 Days|Participants with available data at Week 8.||percentage of participants|||Number
819672|NCT01130168|Primary|TWA Change From Baseline (0 Hours) to 12 Hours in Central Systolic Blood Pressure (SBP) After A Single Dose of Treatment|Central SBP was measured by the SphygmoCor® device. Single dose effects on central SBP were estimated as a time-weighted average change from baseline over the 12-hour post single dose observation period.|Baseline (0 hrs), 12 hours post-dose (Day 1)|"33 participants completed all study periods and provided more than 1 period of BP data, and were thus evaluable for the BP analyses.
Unreliable SphygmoCor® data were collected for one participant in the ISM ER treatment group, therefore this participant was excluded from the single dose SBP analysis."||mm mercury (Hg)||Standard Deviation|Least Squares Mean
819673|NCT01130168|Primary|Change From Baseline (0 Hours) to Week 4 in Heart-Rate-Corrected AIx After Multiple Doses of Treatment|"The augmentation index (AIx) is a measure of systemic arterial stiffness, and is the ratio of augmented aortic pressure (Δ P) to central pulse pressure expressed as a percent. AIx = (ΔP/PP) x 100, where P = pressure and PP = Pulse Pressure. Because heart rate (HR) affects AIx, AIx was corrected to a HR of 75 beats per minute (bpm) as follows:
HR-corrected AIx = -0.39 x (75 - HR) + AIx. This value was used for all AIx analyses."|Baseline (0 hrs), 24 hours after the Day 28 dose|"33 participants completed all study periods and provided more than 1 period of BP data, and were thus evaluable for the BP analyses.
Unreliable SphygmoCor® data were collected for two participants in the ISM ER treatment group, therefore these participants were excluded from the multiple dose AIx analysis."||percent||Standard Deviation|Least Squares Mean
819674|NCT01130168|Primary|Time-weighted Average (TWA) Change From Baseline (0 Hours) to 12 Hours in Heart-Rate-Corrected Augmentation Index (AIx) After A Single Dose of Treatment|"The augmentation index (AIx) is a measure of systemic arterial stiffness, and is the ratio of augmented aortic pressure (Δ P) to central pulse pressure expressed as a percent. AIx = (ΔP/PP) x 100, where P = pressure and PP = Pulse Pressure. Single dose effects on AIx were estimated as a time-weighted average change from baseline over the 12-hour post single dose observation period. Because heart rate (HR) affects AIx, AIx was corrected to a HR of 75 beats per minute (bpm) as follows:
HR-corrected AIx = -0.39 x (75 - HR) + AIx. This value was used for all AIx analyses."|Baseline (0 hrs), 12 hours post-dose (Day 1)|"33 participants completed all study periods and provided more than 1 period of BP data, and were thus evaluable for the BP analyses.
Unreliable SphygmoCor® data were collected for one participant in the ISM ER treatment group, therefore this participant was excluded from the single dose AIx analysis."||percent||Standard Deviation|Least Squares Mean
819675|NCT01130337|Secondary|Percentage of Participants With Objective Response|An objective response was defined as either a complete response (CR) or a partial response (PR). Using the Response Evaluation Criteria in Solid Tumors (RECIST), CR was defined as the disappearance of all target lesions and all non-target lesions, normalization of tumor marker level, and no new lesions. PR was defined as the disappearance of all target lesions and persistence of greater than or equal to (≥) 1 non-target lesions and/or the maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of the longest diameter of target lesions, and no new lesions or unequivocal progression of existing non-target lesions.|Between Days 7 and 21 of the 3rd cycle of neoadjuvant treatment, thereafter, every 9 weeks during adjuvant treatment and then after adjuvant treatment every 3 months until Month 25|ITT population.||percentage of participants|||Number
819676|NCT01130337|Secondary|Percentage of Participants With Complete Tumor Resection (R0)|R0 resection was defined as having performed a complete resection of the tumor with adequate tumor-free margins and regional lymph node extirpation.|Between Days 7 and 21 of the 3rd cycle of neoadjuvant treatment, thereafter, every 9 weeks during adjuvant treatment and then after adjuvant treatment every 3 months until Month 25|"ITT population. Here number of participants analyzed included those who underwent surgery."||percentage of participants||95% Confidence Interval|Number
819677|NCT01130337|Secondary|Percentage of Participants With Pathological Complete Response (pCR)|pCR was defined as an absence of any invasive cancer cell of the primary tumor after the time of major neoadjuvant chemotherapy, with or without surgery.|Between Days 7 and 21 of the 3rd cycle of neoadjuvant treatment, thereafter, every 9 weeks during adjuvant treatment and then after adjuvant treatment every 3 months until Month 25|ITT population.||percentage of participants||95% Confidence Interval|Number
819678|NCT01130337|Primary|Percentage of Participants With Disease-free Survival (DFS) at Month 18|DFS was the time elapsed from the time of surgery (for complete resection [R0] participants) until the date on which progression or death from any cause was documented (whichever occured first). Progression was defined as target lesions greater than (>) 20 percent (%) increase in the sum of the longest diameter (SLD) taking as reference the smallest SLD recorded since the treatment started (nadir) and minimum 5 millimeter (mm) increase over the nadir. When the sum becomes very small, increases within the measurement error (2-3 mm) can lead to a 20% increase. Participants who did not present progression and who had not died were censored on the last date on which it was known that there was no progression (last response assessment).|Month 18|ITT population.||percentage of participants||95% Confidence Interval|Number
819684|NCT01130532|Secondary|"Change From Week 12 to Week 16 Percentage of Yes Responses to Sexual Encounter Profile (SEP) Questions 3"|"Assessed the percentage of Yes responses to the SEP diary Question 3 Did your erection last long enough for you to have successful intercourse? from Week 12 (end of double-Blind treatment) to Week 16 (end of open-label treatment)."|12 weeks and 16 weeks|"All participants who were entered the open-label treatment, received at least 1 dose of study drug during open-label treatment, had Week 12 and at least 1 SEP diary Question 3 measurement during open-label treatment, excluding those with IIEF-EF domain score ≥26 (normal) at baseline. Last observation carried forward (LOCF) principle was used."||"percentage of yes responses"||Standard Deviation|Mean
819685|NCT01130532|Secondary|Change From 12 Weeks to 16 Weeks in Participant's International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score|Self-reported erectile function over the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function.|12 weeks and 16 weeks|"All participants who were entered the open-label treatment, received at least 1 dose of study drug during open-label treatment, had Week 12 and at least 1 IIEF-EF measurement during open-label treatment, excluding those with IIEF-EF domain score ≥26 (normal) at baseline. Last observation carried forward (LOCF) principle was used."||units on a scale||Standard Deviation|Mean
819686|NCT01130532|Secondary|Percentage of Participants Having International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score Greater Than or Equal to 26 From 12 to 16 Weeks|Self-reported erectile function over the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Data presented are the percentage of participants who return to normal erectile function (IIEF-EF domain score ≥26) at end of open-label extension treatment period (Period IV).|12 weeks through 16 weeks|"All participants who were entered the open-label treatment, received at least 1 dose of study drug during open-label treatment, had Week 12 and at least 1 IIEF-EF measurement during open-label treatment, excluding those with IIEF-EF domain score ≥26 (normal) at baseline. Last observation carried forward (LOCF) principle was used."||percentage of participants|||Number
819687|NCT01130532|Secondary|Treatment Satisfaction Scale (TSS) – Partner Satisfaction With Medication Score at Week 12 Endpoint|The TSS - partner satisfaction with medication measured participant's partner satisfaction with treatment based on a 13-item questionnaire. The overall score was converted to a 0-100 scale with higher numbers on the scale indicating greater satisfaction. Satisfaction with medication was analyzed using analysis of covariance (ANOVA). The model included factors of study, treatment group, and pooled site within study.|Week 12|"All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline partner's satisfaction with medication measurement, excluding those with IIEF-EF domain score ≥26 (normal) at baseline. Last observation carried forward (LOCF) principle was used."||units on a scale||Standard Error|Least Squares Mean
819688|NCT01130532|Secondary|Change From Baseline to 12-Week Endpoint in Treatment Satisfaction Scale (TSS) - Partner|The TSS measured participant's partner satisfaction with treatment based on a 13-item questionnaire. The overall score for each of five TSS domains (confidence to complete sexual activity, ease of erection, pleasure from sexual activity, erectile function satisfaction, and satisfaction with orgasm) was converted to a 0-100 scale with higher numbers on the scale indicating greater satisfaction. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.|Baseline, 12 weeks|"All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline partner's TSS measurement, excluding those with IIEF-EF domain score ≥26 (normal) at baseline. Last observation carried forward (LOCF) principle was used."||units on a scale||Standard Error|Least Squares Mean
819689|NCT01130532|Secondary|Change From Baseline to 12-Week Endpoint in the International Index of Erectile Function (IIEF) Question 15 (Sexual Confidence)|Self-reported erectile function over the past 4 weeks. Question 15, confidence in the ability to get an erection, is scored from 1 (very low confidence) to 5 (very high confidence). Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.|Baseline, 12 weeks|"All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline IIEF question 15 (Sexual Confidence) assessment, excluding those with IIEF-EF domain score ≥26 (normal) at baseline. Last observation carried forward (LOCF) principle was used."||units on a scale||Standard Error|Least Squares Mean
819714|NCT01130597|Secondary|Percentage of Participants With Serum Potassium in the Range of 3.5 – 5.5 mEq/L at Week 4||28 Days|Participants with available data at Week 4.||percentage of participants|||Number
819690|NCT01130532|Secondary|Treatment Satisfaction Scale (TSS) - Patient Satisfaction With Medication Score at Week 12 Endpoint|The TSS - patient satisfaction with medication measured participant satisfaction with treatment based on a 13-item questionnaire. The overall score was converted to a 0-100 scale with higher numbers on the scale indicating greater satisfaction. Satisfaction with medication was analyzed using analysis of covariance (ANOVA). The model included factors of study, treatment group, and pooled site within study.|Week 12|"All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline participant's satisfaction with medication measurement, excluding those with IIEF-EF domain score ≥26 (normal) at baseline. Last observation carried forward (LOCF) principle was used."||units on a scale||Standard Error|Least Squares Mean
819691|NCT01130532|Secondary|Change From Baseline to 12-Week Endpoint in Treatment Satisfaction Scale (TSS) - Patient|The TSS measured participant satisfaction with treatment based on a 13-item questionnaire. The overall score for each of five TSS domains (confidence to complete sexual activity, ease of erection, pleasure from sexual activity, erectile function satisfaction, and satisfaction with orgasm) was converted to a 0-100 scale with higher numbers on the scale indicating greater satisfaction. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.|Baseline, 12 weeks|"All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline TSS measurement, excluding those with International Index of Erectile Function - Erectile Function (IIEF-EF) domain score ≥26 (normal) at baseline. Last observation carried forward (LOCF) principle was used."||units on a scale||Standard Error|Least Squares Mean
819692|NCT01130532|Secondary|"Change From Baseline to 12-Week in Percentage of Yes Responses to Sexual Encounter Profile (SEP) Questions 1-5"|Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Questions 1-5. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.|Baseline, 12 weeks|"All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline SEP Questions assessment, excluding those with International Index of Erectile Function - Erectile Function (IIEF-EF) domain score ≥26 (normal) at baseline. Last observation carried forward (LOCF) principle was used."||"percentage of yes responses"||Standard Error|Least Squares Mean
819693|NCT01130532|Secondary|Change From Baseline to 12-Week Endpoint in the International Index of Erectile Function - Overall Satisfaction (IIEF-OS) Domain Score|Self-reported overall satisfaction over the past 4 weeks. IIEF-OS is the sum of Questions 13 and 14; each question scored as 1 (low/no satisfaction) through 5 (high satisfaction) with total subscore for the 2 questions of 2 to 10. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.|Baseline, 12 weeks|"All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline IIEF-OS measurement, excluding those with International Index of Erectile Function - Erectile Function (IIEF-EF) domain score ≥26 (normal) at baseline. Last observation carried forward (LOCF) principle was used."||units on a scale||Standard Error|Least Squares Mean
819694|NCT01130532|Secondary|Change From Baseline to 12-Week Endpoint in the International Index of Erectile Function - Intercourse Satisfaction (IIEF-IS) Domain Score|Self-reported intercourse satisfaction over the past 4 weeks. IIEF-IS is the sum of Questions 6, 7 and 8 of the IIEF. Scores range from 0 (low/no satisfaction) to 5 (high satisfaction) for each question, with the total possible score for the 3 questions of 0 to 15. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.|Baseline, 12 weeks|"All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline IIEF-IS measurement, excluding those with International Index of Erectile Function - Erectile Function (IIEF-EF) domain score ≥26 (normal) at baseline. Last observation carried forward (LOCF) principle was used."||units on a scale||Standard Error|Least Squares Mean
819695|NCT01130532|Secondary|Change From Baseline to 12-Week Endpoint in the International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score|Self-reported erectile function over the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.|Baseline, 12 weeks|"All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline IIEF-EF measurement, excluding those with IIEF-EF domain score ≥26 (normal) at baseline. Last observation carried forward (LOCF) principle was used."||units on a scale||Standard Error|Least Squares Mean
819696|NCT01130532|Primary|Percentage of Participants Having an International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score Greater Than or Equal to 26 Through 12-Week Endpoint (Double-Blind Treatment Period)|Self-reported erectile function over the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Data presented are the percentage of participants who return to normal erectile function (IIEF-EF domain score ≥26) at end of double-blind treatment period (Period III).|Baseline through 12 weeks|"All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline IIEF-EF measurement, excluding those with IIEF-EF domain score ≥26 (normal) at baseline. Last observation carried forward (LOCF) principle was used."||percentage of participants|||Number
819697|NCT01130597|Secondary|Change in ACR From Baseline to Week 8 Among Participants With Urine ACR ≥ 30 mg/g at Baseline||Baseline and Day 56|Participants with urine ACR ≥ 30 mg/g at baseline and available data at Week 8||mg/g||Standard Error|Mean
819716|NCT01130740|Secondary|PHQ-8|This is an 8-item self-report scale, all items are rated on a score of 0-3, for a total range of 0-24. Higher scores indicate more depressive symptoms. The Mixed Models Analysis described below utilizes a common baseline mean rather than means for the individual arms. This common baseline mean is presented here, and the raw baseline measures per group are presented in the baseline information section.|12-months|||units on a scale||Standard Error|Mean
819717|NCT01130740|Secondary|Short Physical Performance Test Protocol|"This is a series of 5 tests covering the domains of balance (3 tests), gait speed (8 foot walk) and time to rise from a chair and return to the seated position five times. The total score ranges from 0 (worst performance) to 12 (best performance).
The Mixed Models Analysis described below utilizes a common baseline mean rather than means for the individual arms. This common baseline mean is presented here, and the raw baseline measures per group are presented in the baseline information section."|12-months|||units on a scale||Standard Error|Mean
819718|NCT01130740|Primary|Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC)|"Self-report measure of lower extremity pain (5 items), stiffness (2 items), and function (17 items) in the past two weeks. All items are rated on a 5-point Likert scale ranging from none (0) to severe / extreme (4), for a total of range of 0-96. Higher scores indicate worse symptoms and poorer function. The Mixed Models Analysis described below utilizes a common baseline mean rather than means for the individual arms. This common baseline mean is presented here, and the raw baseline measures per group are presented in the baseline information section."|12-months|All enrolled participants were analyzed, on an intent to treat basis. One enrolled participants in the Usual Care grouped changed clinical care to an enrolled OA Intervention provider after randomization, so that participant was analyzed with the OA intervention group.||units on a scale||Standard Error|Mean
819719|NCT01130831|Secondary|Number of Tablets Per Day||12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior||Number of Tablets||Standard Deviation|Mean
819720|NCT01130831|Secondary|Change From Baseline in Mean Total Daily Dose of Calcium at 12 Months||Baseline and 12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.||mg||Standard Deviation|Mean
819721|NCT01130831|Secondary|Change From Baseline in Vitamin D Dose at 12 Months||Baseline and 12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.||ng||Standard Deviation|Mean
819722|NCT01130831|Secondary|Percent of Subjects With Hypercalcemic Events on Lanthanum Carbonate|Hypercalcemia defined as total serum calcium above 11.22 mg/dL|12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.||percentage of subjects|||Number
819723|NCT01130831|Secondary|Percent of Subjects With Hypercalcemic Events on Calcium-based Phosphate Binder Therapy|Hypercalcemia is defined as total serum calcium level above 11.22 mg/dL.|Baseline|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.||percentage of subjects|||Number
819724|NCT01130831|Secondary|Percent of Subjects With Hypocalcemic Events on Lanthanum Carbonate|Hypocalcemia is defined as serum calcium levels below 8.02 mg/dL|12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.||percentage of subjects|||Number
819725|NCT01130831|Secondary|Percent of Subjects With Hypocalcemic Events on Calcium-based Phosphate Binder Therapy|Hypocalcemia is defined as serum calcium levels below 8.02 mg/dL|Baseline|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.||percentage of subjects|||Number
819726|NCT01130831|Secondary|Percent Change From Baseline in 1,25-Hydroxy Vitamin D Levels at 12 Months||Baseline and 12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy. Note that there are a high number of missing values (n=38) for this outcome which does not allow for any meaningful comparison.||percent change in vitamin D||Standard Deviation|Mean
819727|NCT01130831|Secondary|Percent Change From Baseline in 25-Hydroxy Vitamin D Levels at 12 Months||Baseline and 12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy. Note that there are a high number of missing values (n=36) for this outcome which does not allow for any meaningful comparison.||percent change in vitamin D||Standard Deviation|Mean
819728|NCT01130831|Secondary|Percent Change From Baseline in iPTH Levels at 12 Months||Baseline and 12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.||percent change in iPTH levels||Standard Deviation|Mean
819729|NCT01130831|Secondary|Percent Change From Baseline in Calcium-Phosphorous Product Levels at 12 Months||Baseline and 12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.||percent change in calcium-phosphorous||Standard Deviation|Mean
819730|NCT01130831|Secondary|Percent Change From Baseline in Calcium Levels at 12 Months||Baseline and 12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.||percent change in calcium levels||Standard Deviation|Mean
819731|NCT01130831|Secondary|Percent Change From Baseline in Phosphorous Levels at 12 Months||Baseline and 12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.||percent change in phosphorous levels||Standard Deviation|Mean
819732|NCT01130831|Secondary|Percent of Subjects That Maintained Control of Intact Parathyroid Hormone (iPTH) Levels on Lanthanum Carbonate Therapy|iPTH levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for iPTH of 150-300 pg/mL|12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.||percentage of subjects|||Number
819733|NCT01130831|Primary|Percent of Subjects That Achieved Controlled Serum Phosphorous Levels on Lanthanum Carbonate|Phosphorous levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum phosphorous of 3.5-5.5 mg/dL.|12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.||percentage of subjects||95% Confidence Interval|Number
819734|NCT01130831|Secondary|Percent of Subjects That Maintained Control of Serum Calcium-Phosphorous Product Levels on Lanthanum Carbonate Therapy|Calcium-phosphorous product levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum calcium-phosphorous product of <55 mg^2/dL^2.|12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.||percentage of subjects|||Number
819735|NCT01130831|Secondary|Percent of Subjects That Maintained Control of Serum Calcium Levels on Lanthanum Carbonate|Calcium levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum calcium of 8.4-9.5 mg/dL.|12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.||percentage of subjects|||Number
819736|NCT01130831|Secondary|Percent of Subjects That Maintained Control of Serum Phosphorous Levels on Lanthanum Carbonate|Phosphorous levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum phosphorous of 3.5-5.5 mg/dL.|12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.||percentage of subjects|||Number
819737|NCT01130831|Secondary|Percent of Subjects That Achieved Controlled Serum Calcium-Phosphorous Product Levels on Lanthanum Carbonate Therapy|Calcium-phosphorous product levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum calcium-phosphorous product of <55 mg^2/dL^2.|12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.||percentage of subjects||95% Confidence Interval|Number
819738|NCT01130831|Secondary|Percent of Subjects That Achieved Controlled Serum Calcium-Phosphorous Product Levels on Calcium-based Phosphate Binder Therapy|Calcium-phosphorous product levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum calcium-phosphorous product of <55 mg^2/dL^2.|Baseline|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.||percentage of subjects||95% Confidence Interval|Number
819739|NCT01130831|Secondary|Percent of Subjects That Achieved Controlled Serum Calcium Levels on Lanthanum Carbonate Therapy|Calcium levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum calcium of 8.4-9.5 mg/dL.|12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.||percentage of subjects||95% Confidence Interval|Number
819740|NCT01130831|Secondary|Percent of Subjects That Achieved Controlled Serum Calcium Levels on Calcium-based Phosphate Binder Therapy|Calcium levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum calcium of 8.4-9.5 mg/dL.|Baseline|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.||percentage of subjects||95% Confidence Interval|Number
819741|NCT01130831|Primary|Percent of Subjects That Achieved Controlled Serum Phosphorous Levels on Calcium-based Phosphate Binder Therapy|Phosphorous levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum phosphorous of 3.5-5.5 mg/dL.|Baseline|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.||percentage of subjects||95% Confidence Interval|Number
819742|NCT01130844|Secondary|Cumulative Amount of MMX Mesalamine Major Metabolite (Ac-5-ASA) Recovered in Urine at Steady State||Over a 24-hour period starting on day 7|PKS||mg||Standard Deviation|Mean
819743|NCT01130844|Secondary|Cumulative Amount of MMX Mesalamine (5-ASA) Recovered in Urine at Steady State||Over a 24-hour period starting on day 7|PKS||mg||Standard Deviation|Mean
819744|NCT01130844|Primary|CL of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State||Over a 24-hour period starting on day 7|PKS||L/h||Standard Deviation|Mean
819745|NCT01130844|Primary|Tmax of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State||Over a 24-hour period starting on day 7|PKS||hours||Full Range|Median
819746|NCT01130844|Primary|Cmax of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State||Over a 24-hour period starting on day 7|PKS||ug/L||Standard Deviation|Mean
819747|NCT01130844|Primary|AUC of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State||2, 4, 6, 9, 12, 16, and 24 hours post-dose on day 7|PKS||ug*h/L||Standard Deviation|Mean
819748|NCT01130844|Primary|Total Body Clearance (CL) of MMX Mesalamine (5-ASA) at Steady State|Clearance of a substance from the blood by the kidneys.|Over a 24-hour period starting on day 7|PKS||L/h||Standard Deviation|Mean
819749|NCT01130844|Primary|Time to Maximum Plasma Concentration (Tmax) of MMX Mesalamine (5-ASA) at Steady State|Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached.|Over a 24-hour period starting on day 7|PKS||hours||Full Range|Median
819750|NCT01130844|Primary|Maximum Plasma Concentration (Cmax) of MMX Mesalamine (5-ASA) at Steady State|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Over a 24-hour period starting on day 7|PKS||ug/L||Standard Deviation|Mean
819751|NCT01130844|Secondary|Percentage of Dose Absorbed For MMX Mesalamine (5-ASA) in Urine at Steady State|The percentage of the dose absorbed was calculated as: 100 x (Xu0-24h 5-ASA + [0.7847* Xu0-24h Ac-5-ASA])/dose, where 0.7847 is the ratio of the molecular weight of 5-ASA (153.14) to the molecular weight of Ac-5-ASA (195.15). Xu0-24h is equal to the cumulative amount recovered in urine in the time interval of 0 to 24 hours.|Over a 24-hour period starting on day 7|PKS||percentage of dose absorbed||Standard Deviation|Mean
819752|NCT01130844|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) of MMX Mesalamine (5-ASA) at Steady State|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|2, 4, 6, 9, 12, 16, and 24 hours post-dose on day 7|The Pharmacokinetic Set (PKS) consisted of all subjects in the Safety Analysis Set who generated sufficient plasma samples to allow reliable determination of Cmax and AUC. The Safety Analysis Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||ug*h/L||Standard Deviation|Mean
819753|NCT01130883|Secondary|Termination of Treatment Due to Noncompliance|Number of participants who discontinued Klacid SR treatment early due to noncompliance with the recommended study medication regimen.|Day 8 - 16|A total of 3128 participants were included in the analysis.||Participants|||Number
819754|NCT01130883|Secondary|Compliance|Number of participants who took their medication according to the prescribed regimen (dose and duration) during the study.|Day 8 - 16|||Participants|||Number
819755|NCT01130883|Secondary|Study Drug Given as the First, Second or Third Antimicrobial Treatment|Number of participants who received Klacid SR as the first, second or third (further) antimicrobial agent.|Day 0|||Participants|||Number
819756|NCT01130883|Secondary|Chest X-ray in Case of Community-Acquired Pneumonia (CAP)|Number of participants in which X-ray findings were suggestive of pneumonia. In participants where the physician suspected CAP, a chest X-ray was performed and reviewed to determine whether findings were indicative of pneumonia.|Day 0|Chest X-ray was performed in 294 of the participants for whom the physician suspected pneumonia.||Participants|||Number
819757|NCT01130883|Secondary|Auscultation|Participants with abnormal auscultation findings (abnormal breath sounds) and type of findings (wheezing, crackles, both, or not reported).|Day 0, Day 8-16|Of the 3128 participants included in the analysis, auscultation findings were not reported for 38 participants at the initial visit and 116 participants at the final visit.||Participants|||Number
819758|NCT01130883|Secondary|Dyspnea and Its Type|Presence of dyspnea (difficulty breathing) and type of dyspnea (exertional, resting, both, or not reported).|Day 0, Day 8-16|||Participants|||Number
819759|NCT01130883|Secondary|Cough and Its Character|Number of participants in which cough was present, and if present, type of cough (irritating, productive, both or not reported)|Day 0, Day 8-16|||Participants|||Number
819760|NCT01130883|Secondary|Bacteriological Investigation (if Available)|The type of agent present in the infection was assessed using bacteriological investigation. Occurrence of the most common agents was reported. Participants may have had more than one pathogen present. Test results were not available prior to enrollment but were reported during the study.|Day 0|Of the 3128 participants included in the analysis, 225 participants had bacteriological investigations conducted at the Initial visit (Day 0). Some participants had more than one finding.||participants|||Number
819761|NCT01130883|Secondary|Body Temperature|Number of participants in which body temperature was increased (temperature above 37 degrees Celsius).|Day 0, Day 8-16|Of the 3128 participants included in the analysis, body temperature was not reported for 6 participants at the Initial visit, and 14 participants at the Second visit.||Participants|||Number
819762|NCT01130883|Primary|Change in Auscultation Findings, Regression of Chest X-ray Findings (Recorded by the Physician)|Auscultation findings (abnormal breath sounds) were assessed at the initial visit (Day 0) and the second visit (Day 8 -16) by the physician. “Regression of chest X-ray findings” were not recorded as it is not part of routine clinical practice to confirm X-ray regression after the participant has clinically recovered from Community-Acquired Pneumonia (CAP).|Day 0, Day 8 - 16|||participants|||Number
819763|NCT01130883|Primary|Disappearance or Significant Alleviation of Symptoms|"Overall therapeutic response, yes or no was determined by the physician based on subjective response regarding disappearance or significant alleviation of symptoms following treatment. The physician also considered objective findings such as auscultation and or chest X-ray results (if available) when determining overall therapeutic response."|Day 8 - 16|A total of 3130 participants were enrolled into the study and 3128 were included in the analysis. Two participants were excluded from the analysis as they did not meet entry criteria (2 participants were less than 18 years of age).||Participants|||Number
819764|NCT01130974|Primary|logMAR Visual Acuity (VA)|Non-inferiority of distance high contrast logMAR lens VA. A negative value indicates improved VA. Lens VA was established for All Study, Dispensed, 2-Week Follow-up Visit, and 1-Month Follow-up Visit|2 week and 1 month follow-up|All eligible, dispensed eyes||logMAR|Participants|Standard Deviation|Mean
819765|NCT01130974|Secondary|Symptoms & Complaints|Subject symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting least favorable symptoms/complaints and 100 being the most favorable score.|Summarized over all follow-up visits through one month|All eligible dispensed eyes, summarized over all follow-up visits through 1 month.||units on a scale|Participants|Standard Deviation|Mean
819766|NCT01130974|Secondary|Lens Movement|Lens movement was assessed as adequate, excessive (> 0.6 mm), insufficient (< 0.2 mm), or adherence. Suboptimal lens movement was defined as a rating other than adequate.|Summarized over all follow-up visits through one month|All Eligible, Dispensed Eyes, Over All Visits summarizes the worst case over the dispensing and all follow-up visits.||eyes|Participants||Number
819767|NCT01130974|Secondary|Lens Centration|"Lens centration was assessed as excellent(fully centered), good (slight decentration, no corneal exposure), fair (decentration, intermittent corneal exposure), or poor (incomplete corneal coverage and/or edge lift).
Suboptimal lens centration was defined as a rating other than excellent."|Summarized over all follow-up visits through 1 month|All Eligible, Dispensed Eyes, Over All Visits summarizes the worst case over the dispensing and all follow-up visits.||eyes|Participants||Number
819768|NCT01130974|Secondary|Lens Deposits|Degree of lens deposits was assessed as none, light, medium, or heavy. Suboptimal lens deposits were defined as a degree rating of medium or heavy. Measured over all visits through one month|Summarized over all follow-up visits through one month|All Eligible, Dispensed Eyes, Over All Visits summarizes the worst case over the dispensing and all follow-up visits.||eyes|Participants||Number
819769|NCT01130974|Secondary|Lens Wettability|Lens wettability was rated as Grade 4-0. Grade 4 = 100% of anterior surface wettable (optimal); Grade 3 = presence of small (< 0.1 mm), individual, discrete non-wetting areas (slight); Grade 2 = presence of single area of non-wetting between 0.1 mm and 0.5 mm in size (mild); Grade 1 = presence of several areas on non-wetting, each between 0.1 mm and 0.5 mm in size (moderate); Grade 0 = presence of one or more non-wetting areas > 0.5 mm in size (severe). Suboptimal lens wettability was defined as a rating other than Grade 4, ie slight, mild, moderate, or severe ratings. Over All Visits summarizes the worst case over the dispensing and all follow-up visits.|Summarized over all follow-up visits through 1 month|All Eligible, Dispensed Eyes, Over All Visits summarizes the worst case over the dispensing and all follow-up visits.||eyes|Participants||Number
819770|NCT01130974|Primary|logMAR Visual Acuity (VA)|Non-inferiority of distance high contrast logMAR lens VA. A negative value indicates improved VA. Lens VA was established for All Study, Dispensed, 2-Week Follow-up Visit, and 1-Month Follow-up Visit|Summarized over all visits, and dispensed visit|All eligible, dispensed eyes||logMAR|Participants|Standard Deviation|Mean
819771|NCT01130974|Primary|Slit Lamp Findings|Graded Slit lamp findings (epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates) > grade 2 over all follow-up visits, summarizes the worst case over all follow-up visits. Graded 0-4 with 0=none and 4=severe|Summarized over all follow-up visits through 1 month|All dispensed eyes with any slit lamp findings > grade 2||eyes|Participants||Number
819772|NCT01131052|Primary|Mean of Weekly Fasting Blood Glucose Concentration|Mean weekly blood glucose concentration at 3 months|3 months|||mg/dL||Standard Deviation|Mean
819773|NCT01131052|Secondary|Mean of Glycosylated Hemoglobin (hbA1c)|Mean glycosylated hemoglobin (hbA1c) at baseline. The A1C test result is reported as a percentage. The higher the percentage, the higher a person’s blood glucose levels have been. A normal A1C level is below 5.7 percent.|6 months|||percent of glycosylated hemoglobin||Standard Deviation|Mean
819774|NCT01131052|Secondary|Mean of Glycosylated Hemoglobin (hbA1c)|Mean glycosylated hemoglobin (hbA1c) at baseline. The A1C test result is reported as a percentage. The higher the percentage, the higher a person’s blood glucose levels have been. A normal A1C level is below 5.7 percent.|3 months|||percent of glycosylated hemoglobin||Standard Deviation|Mean
819775|NCT01131052|Secondary|Mean of Daily Blood Glucose Concentration|Mean of daily blood glucose concentration at baseline|Baseline|||mg/dL||Standard Deviation|Mean
819776|NCT01131052|Secondary|Mean of Glycosylated Hemoglobin (hbA1c)|Mean glycosylated hemoglobin (hbA1c) at baseline. The A1C test result is reported as a percentage. The higher the percentage, the higher a person’s blood glucose levels have been. A normal A1C level is below 5.7 percent.|Baseline|||percent of glycosylated hemoglobin||Standard Deviation|Mean
819777|NCT01131052|Secondary|Mean Blood Glucose Concentration|Mean blood glucose concentration at baseline|Baseline|||mg/dL||Standard Deviation|Mean
819778|NCT01131052|Primary|Percent of Participants With a Mean Blood Glucose Concentration of Less Than 40 mg/dL|Mean weekly blood glucose concentration less than 40 mg/dL at 3 months|3 months|||percentage of participants|||Number
819779|NCT01131052|Primary|Percent of Participants With a Mean Blood Glucose Concentration of Less Than 70 mg/dL|Mean weekly blood glucose concentration less than 70 mg/dL at 3 months|3 months|||percentage of participants|||Number
819780|NCT01131065|Secondary|Safety and Tolerance|Safety and tolerance to the product administration will be measured by the detection of adverse events or clinically relevant changes in vital signs.|During and after each product administration (during the 12 month treatment period)|||participants|||Number
819781|NCT01131065|Primary|HBsAb Pre-infusion Levels (Trough Levels Before Each Niuliva Administration)||Days 3 to 7, Weeks 2 to 4, Months 2 to 6, and Months 7 to 12|||IU/L||Standard Deviation|Mean
819782|NCT01131065|Primary|HBV Recurrence|HBV recurrence is measured by seroconversion or reappearance of HBsAg and HBV DNA positivity|First six and twelve months after liver transplantation|||participants|||Number
819783|NCT01131078|Secondary|Duration of Overall Complete Response|Duration of complete response was calculated as the time in months from the date of randomization to the date of first documentation of CR. Kaplan-Meier estimates were used for analysis.|Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years|ITT Population; Only participants with a best overall response were included in the analysis.||months||95% Confidence Interval|Median
819784|NCT01131078|Secondary|Duration of Stable Disease (SD)|Duration of SD was calculated as the number of months the participants remained in CR, PR or SD. Kaplan-Meier estimates were used for analysis.|Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death|ITT Population; Only participants with a best overall response of CR, PR, or SD were included in the analysis.||months||95% Confidence Interval|Median
819785|NCT01131078|Secondary|Duration of Overall Response|Duration of overall response included participants who achieved a CR or PR.|Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death|ITT Population; only participants with a best overall response of CR or PR were included in the analysis.||months||95% Confidence Interval|Median
819786|NCT01131078|Secondary|Percentage of Participants With Progressive Disease Within 12 Weeks From Start of Treatment|Early progression was the proportion of participants with progressive disease within 12 weeks from the start of treatment.|Randomization, Weeks 3, 6 and 9, and 12|ITT Population; All participants with evaluable data were included in the analysis.||percentage of participants||95% Confidence Interval|Number
819787|NCT01131078|Secondary|Percentage of Participants With Stable Disease|Stable disease rate was the proportion of participants who achieved CR, PR, or SD.|Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death|ITT Population; All participants with evaluable data were included in the analysis||percentage of participants||95% Confidence Interval|Number
819788|NCT01131078|Secondary|Percentage of Participants With a Best Overall Response of CR or PR|CR: Complete disappearance of all target lesions; PR: At least 30% decrease in the sum of the longest diameter of all target lesions taking as reference the baseline sum of all target lesions;|Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death|ITT Population; All participants with evaluable data were included in the analysis||percentage of participants||95% Confidence Interval|Number
819820|NCT01131520|Secondary|Alcohol, Smoking & Substance Involvement Screening Test (ASSIST) Score|ASSIST's Global Continuum of Illicit Drug Risk Score which ranges from 0 to 308. A higher score is associated with higher risk.|6 month post-baseline|||units on a scale||Standard Error|Least Squares Mean
819789|NCT01131078|Secondary|Percentage of Participants by Best Overall Response|Best overall response is defined as the best response recorded from the date of randomization until disease progression or recurrence. Complete response (CR): at least 2 determinations of CR at least 4 weeks apart before progression; Partial response (PR): at least 2 determinations of PR at least 4 weeks apart before progression; Stable disease (SD): at least one SD assessment; Progressive Disease (PD): Disease progression or death due to underlying cancer. CR: Complete disappearance of all target lesions; PR: At least 30% decrease in the sum of the longest diameter of all target lesions taking as reference the baseline sum of all target lesions; PD: At least 20% decrease in the sum of the longest diameter of all target lesions taking as reference the baseline sum of longest diameter of all target lesions or the appearance of one or more new lesions; SD: Neither sufficient shrinkage to qualify for CR or PR or increase in lesions;|Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death|ITT Population; All participants with evaluable data were included in the analysis||percentage of participants|||Number
819790|NCT01131078|Primary|Time to Progression (TTP)|TTP is defined as the time from date of randomization until objective tumor progression or death due to any cause. It includes deaths and thus can be correlated to overall survival.|Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death|ITT Population; only those participants with an event of disease progression or death were included in the analysis||months||95% Confidence Interval|Median
819791|NCT01131078|Secondary|Time to Progression Excluding Deaths Not Related to Underlying Cancer|The failure event was defined as tumor progression excluding only deaths not related to underlying cancer. Kaplan-Meier estimates were used for analysis.|Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death|ITT Population; only participants with a time to progression event (excluding deaths not related to underlying cancer) were included in the analysis.||months||95% Confidence Interval|Median
819792|NCT01131078|Secondary|Percentage of Participants With Progression Excluding Deaths Not Related to Underlying Cancer|The failure event was defined as tumor progression excluding only deaths not related to underlying cancer.|Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death|ITT Population||percentage of participants|||Number
819793|NCT01131078|Secondary|Time to Progression Excluding Deaths|The failure event was defined as tumor progression excluding deaths due to any reason. Kaplan-Meier estimates were used for analysis.|Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death|ITT Population; Only participants with a time to progression event (excluding deaths) were included in the analysis.||months||95% Confidence Interval|Median
819794|NCT01131078|Secondary|Percentage of Participants With Progression Excluding Deaths|The failure event was defined as tumor progression excluding deaths due to any reason.|Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death|ITT Population||percentage of participants|||Number
819795|NCT01131078|Secondary|Time to Treatment Failure|Time to treatment failure is defined as a composite endpoint measuring time from date of randomization to discontinuation of treatment for any reason, including disease progression, death, treatment toxicity, insufficient therapeutic response, failure to return, refusing treatment, being unwilling to cooperate and withdrawing consent. Analysis was performed using Kaplan-Meier estimates.|Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death|ITT Population; only participants with a treatment failure event were included in the analysis.||months||95% Confidence Interval|Median
819796|NCT01131078|Secondary|Percentage of Participants With Treatment Failure|Treatment failure is defined as discontinuation of treatment for any reason, including disease progression, death, treatment toxicity, insufficient therapeutic response, failure to return, refusing treatment, being unwilling to cooperate and withdrawing consent.|Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death|ITT Population||percentage of participants|||Number
819797|NCT01131078|Secondary|Overall Survival|Overall survival is defined as the time from date of randomization until death from any cause; Kaplan-Meier estimates were used for analysis.|Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death|ITT Population; Only participants with an event (death) were included in the analysis.||months||95% Confidence Interval|Median
819798|NCT01131078|Secondary|Percentage of Participants Who Died|Overall survival is defined as the time from date of randomization until death from any cause|Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death|ITT Population||percentage of participants|||Number
819799|NCT01131078|Primary|Percentage of Participants With Disease Progression or Death|Disease progression was defined according to National Cancer Institute (NCI) guidelines and best clinical practices.|Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death|ITT Population;||percentage of participants|||Number
819800|NCT01131130|Secondary|Lens Wettability, Test Lens vs. Air Optix Aqua|Lens wettability was assessed at each visit as Grade 4 – 0, with 4=optimal (100% of anterior surface wettable) and 0=severe (Presence of one or more non-wetting areas > 0.5 mm in size).|7 days|All eligible, dispensed eyes||eyes|Participants||Number
819801|NCT01131130|Primary|Comfort Throughout the Day - Test Lens vs. Acuvue Oasys|Subjective measurements of lens comfort were rated on a scale from 0 to 100, where 100 was the most favorable.|7 days|All eligible, dispensed eyes||units on a scale|Participants|Standard Deviation|Least Squares Mean
819802|NCT01131130|Primary|Comfort Throughout the Day - Test Lens vs. Air Optix Aqua Lens|Subjective measurements of lens comfort were rated on a scale from 0 to 100, where 100 was the most favorable.|7 days|All eligible dispensed eyes||units on a scale|Participants|Standard Deviation|Least Squares Mean
819803|NCT01131130|Secondary|Lens Wettability, Test Lens vs. Acuvue Oasys|Lens wettability was assessed at each visit as Grade 4 – 0, with 4=optimal (100% of anterior surface wettable) and 0=severe (Presence of one or more non-wetting areas > 0.5 mm in size).|7 days|All eligible, dispensed eyes||eyes|Participants||Number
819806|NCT01131299|Secondary|Lipoprotein Insulin Resistance Index (LIRI) After 12-14 Weeks Intervention, Compared to Baseline for Alpha-cyclodextrin (a-CD) and Placebo Groups After 12-14 Weeks, Compared to Baseline|LIRI was measured at the end of each study arm (a-CD or placebo). a-CD (2g) was taken orally three times a day for 12-14 weeks. Placebo (2 tablets) was taken orally for 12-14 weeks. There was a one-week washout period between each arm.|24-28 weeks|The LIRI score is a composite of six lipoprotein parameters (VLDL, HDL and LDL, and concentrations of large VLDL, large HDL and small LDL subclasses) measured by NMR spectroscopy, which may be apparent years before the onset of overt hyperglycemia. LIRI scores range from zero, the most insulin sensitive, to 100, the most insulin resistant.||percentage||Standard Error|Mean
819807|NCT01131299|Secondary|Serum Glucose Levels After 12-14 Weeks Intervention, Compared to Baseline for Alpha-cyclodextrin (a-CD) and Placebo Groups After 12-14 Weeks, Compared to Baseline|Serum glucose levels was measured at the end of each study arm (a-CD or placebo). a-CD (2g) was taken orally three times a day for 12-14 weeks. Placebo (2 tablets) was taken orally for 12-14 weeks. There was a one-week washout period between each arm.|24-28 weeks|||mg/dL||Standard Error|Mean
819808|NCT01131299|Secondary|Small LDL Particle Number (by NMR Spectrometry of Lipoproteins) After 12-14 Weeks Intervention, Compared to Baseline for Alpha-cyclodextrin (a-CD) and Placebo Groups After 12-14 Weeks, Compared to Baseline|Small LDL particle numbers were measured at the end of each study arm (a-CD or placebo). a-CD (2g) was taken orally three times a day for 12-14 weeks. Placebo (2 tablets) was taken orally for 12-14 weeks. There was a one-week washout period between each arm.|24-28 weeks|||nmol/L||Standard Error|Mean
819809|NCT01131299|Primary|Total Serum Cholesterol Levels for Alpha-cyclodextrin (a-CD) and Placebo Groups After 12-14 Weeks, Compared to Baseline|Total cholesterol levels were measured at the end of each study arm (a-CD or placebo). a-CD (2g) was taken orally three times a day for 12-14 weeks. Placebo (2 tablets) was taken orally for 12-14 weeks. There was a one-week washout period between each arm.|24-28 weeks|||mg/dL||Standard Error|Mean
819810|NCT01131455|Primary|CT Scan for Fusion Analysis|There will be no outcome analysis for the CT scan performed on the 10 patients due to the death of the primary investigator.|8 weeks post op.||||||
819811|NCT01131494|Primary|Oropharyngeal Swallowing Score|Based on videofluoroscopy, were awarded points for the swallowing events according to their clinical relevance. The sum of these points results in the OSP (Oropharyngeal Swallowing Score), so that higher scores signify greater impairment in swallowing. OSP-score range from 0 to 243.5. This tool is being validated for that group.|five weeks|||Scores on a scale||Standard Deviation|Mean
819812|NCT01131494|Secondary|Quality of Life|Measured by the Swal-qol (Quality of life in Swallowing disorders). In this questionnaire the score range from 0 to 100 and higher scores is better quality of life.|five weeks|||scores in a scale||Inter-Quartile Range|Median
819813|NCT01131507|Secondary|Change From Baseline in Growth Percentiles at Month 3, 6, 9 and 12|Participant’s ability to thrive was evaluated through growth percentiles for weight-for-age, length-for-age and weight-for-length recorded on Center for Disease Control and Prevention (CDC) growth charts during each treatment visit.|Baseline, Month 3, 6, 9 and 12|Safety population included all participants who received at least 1 dose of study drug. Here, 'n' specifies number of participants who were evaluable for various categories at each time point.||growth percentile||Full Range|Median
819814|NCT01131507|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs)|TEAE was any event not present prior to exposure to study drug or any event already present that worsened in either intensity or frequency following exposure to test drug. Serious AE (SAE) was any event that resulted in death, immediately life threatening, hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Number of participants with TEAEs, SAEs, TEAE’s relationship to study drug (unrelated, possible and probable) and on the basis of severity (mild [minimal/no treatment and did not interfere with daily activities], moderate [resulted in a low level of inconvenience or concern with the therapeutic measures and may have caused some interference with functioning] and severe [interrupted participant’s usual daily activity, may have required systemic drug therapy or other treatment and were usually incapacitating]) with a frequency threshold of above 5% were reported.|Up to Month 12 or early termination|Safety population included all participants who received at least 1 dose of study drug.||participants|||Number
819815|NCT01131520|Secondary|Human Immunodeficiency Virus (HIV) Risk Assessment Battery Subscale Score|HIV Drug Use Risk Assessment Battery Subscale Score ranges from 0 to 22. A higher score is considered to be associated with higher risk.|12 month post-baseline|||units on a scale||Standard Error|Least Squares Mean
819816|NCT01131520|Secondary|Human Immunodeficiency Virus (HIV) Risk Assessment Battery Subscale|HIV Drug Use Risk Assessment Battery Subscale Score ranges from 0 to 22. A higher score is considered to be associated with higher risk.|6 month post-baseline|||units on a scale||Standard Error|Least Squares Mean
819817|NCT01131520|Secondary|Hair Testing|Predicted Probabilities for testing positive on the Radioimmunoassay (RIA) Hair Testing for opiates, cocaine, amphetamine and THC, calculated from generalized estimating equations.|12 month post-baseline|The sample includes participants who provided usable hair testing data at baseline||predicted probability of positive test||Standard Error|Least Squares Mean
819818|NCT01131520|Secondary|Hair Testing|The predicted probabilities for testing positive on Radioimmunoassay (RIA) Hair Testing for opiates, cocaine, amphetamine and tetrahydrocannabinol (THC), calculated from generalized estimating equations.|6 month post-baseline|The sample includes participants who provided usable hair testing data at baseline.||predicted probability of positive test||Standard Error|Least Squares Mean
819819|NCT01131520|Secondary|Alcohol, Smoking & Substance Involvement Screening Test (ASSIST) Score|ASSIST's Global Continuum of Illicit Drug Risk Score which ranges from 0 to 308. A higher score is associated with higher risk.|12 months post-baseline|||units on a scale||Standard Error|Least Squares Mean
819821|NCT01131520|Secondary|Human Immunodeficiency Virus (HIV) Drug Use Risk Assessment Battery Subscale|HIV Drug Use Risk Assessment Battery Subscale Score ranges from 0 to 22. A higher score is considered to be associated with higher risk.|3 months post-baseline|||units on a scale||Standard Error|Least Squares Mean
819822|NCT01131520|Primary|Hair Testing|The number of participants testing positive on Radioimmunoassay (RIA) Hair Testing for opiates, cocaine, amphetamine and tetrahydrocannabinol (THC)|3 month post-baseline|The number of participants of the total sample who agreed to provide an analyzable hair specimen. Hair testing was not available for subjects not interviewed, those who refused testing, or who were unable to provide a sufficient quantity of hair for testing.||Participants|||Count of Participants
819823|NCT01131520|Primary|Alcohol, Smoking & Substance Involvement Screening Test (ASSIST) Score|The ASSIST's Global Continuum of Illicit Drug Risk was used. A higher score is considered more severe risk. The scores range from 0 to 308.|3 months post-baseline|||units on a scale||Standard Error|Least Squares Mean
819824|NCT01131585|Primary|Change in Best-Corrected Visual Acuity (BCVA) From Baseline to Month 12|Mean change in Best-Corrected Visual Acuity (BCVA) letters at 12 months compared to baseline was measured using Visual acuity (VA). VA accounts for the number of letters a participant can see using Early Treatment Diabetic Retinopathy Study (EDTRS)-like visual acuity testing charts, from a sitting position at a testing distance of 4 meters. BCVA means that the participant’s refraction is already taken into account when VA is determined. A higher BCVA number at 12 months in reference to baseline indicates improved BCVA.|12 months|Full Analysis Set consisted of all participants who received at least one application of study treatment and had at least one post-baseline assessment for BCVA. No patient completed the 12 months observational period due to study early termination; therefore, the last observation carried forward (LOCF) method was used with data from 11.1 months.||Letters||Standard Deviation|Mean
819825|NCT01131676|Secondary|Percentage of Participants With the Composite Microvascular Outcome|"Composite microvascular outcome defined as:
Initiation of retinal photocoagulation
Vitreous haemorrhage
Diabetes-related blindness, or
New or worsening nephropathy defined as:
New onset of macroalbuminuria; or
Doubling of serum creatinine level accompanied by an eGFR (based on modification of diet in renal disease (MDRD) formula) ≤45 mL/min/1.73m2; or
Initiation of continuous renal replacement therapy, or
Death due to renal disease. Percentage of patients with the event are presented."|From randomisation to individual end of observation, up to 4.6 years|TS (evaluable cases)||percentage of participants|||Number
819826|NCT01131676|Secondary|Percentage of Participants With New Onset Macroalbuminuria|New onset macroalbuminuria defined as UACR >300 mg/g. Percentage of patients with the event are presented.|From randomisation to individual end of observation, up to 4.6 years|TS (evaluable cases)||percentage of participants|||Number
819827|NCT01131676|Secondary|Percentage of Participants With New Onset Albuminuria|"New onset albuminuria defined as urine albumin / creatinine ratio (UACR) ≥30 mg/g.
Percentage of patients with the event are presented."|From randomisation to individual end of observation, up to 4.6 years|TS (evaluable cases)||percentage of participants|||Number
819828|NCT01131676|Secondary|Percentage of Participants With Heart Failure Requiring Hospitalisation (Adjudicated)|Heart failure requiring hospitalisation (adjudicated). Percentage of patients with the event are presented.|From randomisation to individual end of observation, up to 4.6 years|TS||percentage of participants|||Number
819829|NCT01131676|Secondary|Percentage of Participants With Silent MI|"Silent MI; defined as presence in the ECG of:
Any Q-wave in leads V2-V3 ≥0.02 seconds or QS complex in leads V2 and V3
Q-wave ≥0.03 seconds and ≥0.1 mV deep or QS complex in leads I, II, aVL, aVF, or V4-V6 in any two leads of a contiguous lead grouping (I, aVL, V6; V4-V6; II, III, and aVF)
R-wave ≥0.04 seconds in V1-V2 and R/S ≥1 with a concordant positive T-wave in the absence of a conduction defect.
It was also required that there had been no adjudicated and confirmed event of either acute MI, hospitalisation for unstable angina, coronary revascularisation procedures or stent thrombosis following randomisation up to and including the date of the specified ECG measurement.
Percentage of patients with the event are presented."|From randomisation to individual end of observation, up to 4.6 years|TS (evaluable cases)||percentage of participants|||Number
819830|NCT01131676|Secondary|Percentage of Participants With the Composite of All Events Adjudicated (4-point MACE): CV Death (Including Fatal Stroke and Fatal MI), Non-fatal MI (Excluding Silent MI), Non-fatal Stroke and Hospitalization for Unstable Angina Pectoris|"The composite of all events adjudicated (4-point MACE): cardiovascular death (including fatal stroke and fatal myocardial infarction), non-fatal myocardial infarction (excluding silent MI), non-fatal stroke and hospitalization for unstable angina pectoris.This is a key secondary endpoint of the trial.
Percentage of patients with the event are presented."|From randomisation to individual end of observation, up to 4.6 years|TS||percentage of participants|||Number
819831|NCT01131676|Primary|Time to the First Occurrence of Any of the Following Adjudicated Components of the Primary Composite Endpoint (3-point MACE): CV Death (Including Fatal Stroke and Fatal MI), Non-fatal MI (Excluding Silent MI), and Non-fatal Stroke.|"Time to the first occurrence of any of the following adjudicated components of the primary composite endpoint (3-point major adverse cardiovascular events (MACE)): cardiovascular (CV) death (including fatal stroke and fatal myocardial infarction (MI)), non-fatal MI (excluding silent MI), and non-fatal stroke.
Percentage of patients with the event are presented."|From randomisation to individual end of observation, up to 4.6 years|TS||percentage of participants|||Number
819832|NCT01138475|Secondary|24 Hour Urine Calcium|This secondary outcome measure is change in 24-hour urine calcium from baseline to final measure at 6 weeks, differences in the 3 arms were compared|6 weeks|Missing data from paricalcitol and cholecalciferol arms||mg/dL||Standard Deviation|Mean
819833|NCT01138475|Secondary|Bone Specific Alkaline Phosphatase|This secondary outcome measure is change in bone specific alkaline phosphatase from baseline to final measure at 6 weeks, differences in the 3 arms were compared|6 weeks|||u/L||Standard Deviation|Mean
819834|NCT01138475|Secondary|N-Telopeptide Cross Linked Urine|This secondary outcome measure is change in N-Telopeptide cross linked urine from baseline to final measure at 6 weeks, differences in the 3 arms were compared|6 weeks|Missing data from cholecalciferol and placebo participant arms||nmol||Standard Deviation|Mean
819835|NCT01138475|Secondary|Osteocalcin|This secondary outcome measure is change in osteocalcin from baseline to final measure at 6 weeks differences in the 3 arms were compared|6 weeks|Missing data from all 3 participant arms||ng/mL||Standard Deviation|Mean
819839|NCT01138475|Secondary|Alkaline Phosphatase|This secondary outcome measure is change in alkaline phosphatase from baseline to final measure at 6 weeks differences were compared between the 3 arms of the study|6 weeks|missing 1 participant data in the paricalcitol group||U/L||Standard Deviation|Mean
819840|NCT01138475|Primary|The Primary Outcome Measure With iPTH|Change in iPTH was compared in each arm from baseline to final measure at 6 weeks the differences were compared in the 3 arms of the study|6 weeks|missing data in paricalcitol and placebo group||pg/mL||Standard Deviation|Mean
819841|NCT01138501|Secondary|Frequency of Adverse Events (AEs)|Adverse event was defined as events occurring after administration of trial product. Severe AEs: considerable interference with subject's daily activities, unacceptable. Moderate AEs: Marked symptoms, moderate interference with the patient's daily activities. Mild AEs: No or transient symptoms, no interference with the patient's daily activities. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.|The adverse events were collected throughout the trial, corresponding to an average of 138 days per subject|Safety analysis set includes all subjects who received at least one dose of the investigational product.||events|||Number
819842|NCT01138501|Primary|The Incidence Rate of FVIII Inhibitors (Greater Than or Equal to 0.6 Bethesda Units (BU))|The incidence rate of FVIII inhibitors was calculated by including all patients with inhibitors in the nominator and including all patients with a minimum 50 exposure plus any patients with less than 50 exposures but with inhibitors in denominator.|The adverse events were collected throughout the trial, corresponding to an average of 138 days per subject.|The safety analysis set includes all 63 subjects who received at least one dose of the investigational product. The analysis of the primary endpoint included all subjects with at least 50 exposure days and/or with inhibitors. A total of 59 subjects had 50 exposure days (EDs).||N with Inhibitors / N with ≥50 EDs|||Number
819843|NCT01138514|Secondary|Number of Participant With Clinical Success on the Investigator's Global Assessment (IGA)|Clinical success was defined as a score of clear (0) or almost clear (1) at Week 10.|10 weeks|per-protocol population||participants|||Number
819844|NCT01138514|Primary|Percent Change From Baseline in Non-inflammatory Lesions||10 weeks|Per protocol population||percentage of lesion reduction||Standard Deviation|Mean
819845|NCT01138514|Primary|Percent Change From Baseline in Inflammatory Lesions||10 weeks|Per protocol population||percentage of lesion reduction||Standard Deviation|Mean
819846|NCT01138657|Secondary|Change in VFQ-25 Ocular Pain Subscore From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit|"The National Eye Institute VFQ-25 is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning.
The VFQ-25 consists of a base set of 25 vision-targeted questions plus an additional single-item general health rating question.
The ocular pain subscore is calculated from the answers to 2 ocular pain-related questions and ranges from 0 to 100, where higher scores or increases in score indicate less pain."|Baseline to Week 6 and Final/Early Termination Visit (up 80 weeks)|Intent-to-treat population with values at both time points; last observation carried forward (LOCF) imputation was used; participants with no values after Week 6 were excluded.||units on a scale||Standard Deviation|Mean
819847|NCT01138657|Secondary|Change in VFQ-25 Near Vision Subscore From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit|"The National Eye Institute VFQ-25 is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning.
The VFQ-25 consists of a base set of 25 vision-targeted questions plus an additional single-item general health rating question.
The distance vision subscore is calculated from the answers to 3 near vision-related questions and ranges from 0 to 100, where higher scores or increases in score indicate better vision-related functioning."|Baseline to Week 6 and Final/Early Termination Visit (up 80 weeks)|Intent-to-treat population with values at both time points; last observation carried forward (LOCF) imputation was used; participants with no values after Week 6 were excluded.||units on a scale||Standard Deviation|Mean
819848|NCT01138657|Secondary|Change in VFQ-25 Distance Vision Subscore From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit|"The National Eye Institute VFQ-25 is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning.
The VFQ-25 consists of a base set of 25 vision-targeted questions plus an additional single-item general health rating question.
The distance vision subscore is calculated from the answers to 3 distance vision-related questions and ranges from 0 to 100, where higher scores or increases in score indicate better vision-related functioning."|Baseline to Week 6 and Final/Early Termination Visit (up 80 weeks)|Intent-to-treat population with values at both time points; last observation carried forward (LOCF) imputation was used; participants with no values after Week 6 were excluded.||units on a scale||Standard Deviation|Mean
819849|NCT01138657|Secondary|Change in Visual Functioning Questionnaire 25 (VFQ-25) Composite Score From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit|"The National Eye Institute VFQ-25 is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning.
The VFQ-25 consists of a base set of 25 vision-targeted questions plus an additional single-item general health rating question. The overall composite score ranges from 0 to 100, where higher scores or increases in score indicate better vision-related functioning."|Baseline to Week 6 and Final/Early Termination Visit (up 80 weeks)|Intent-to-treat population with values at both time points; last observation carried forward (LOCF) imputation was used; participants with no values after Week 6 were excluded.||units on a scale||Standard Deviation|Mean
819850|NCT01138657|Secondary|Percent Change in Central Retinal Thickness in Each Eye From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit|Central retinal thickness was measured using optical coherence tomography and assessed by a central reader.|Baseline to Week 6 and Final/Early Termination Visit (up to 80 weeks)|Intent-to-treat population with values at both time points; last observation carried forward (LOCF) imputation was used; participants with no values after Week 6 were excluded.||percent change||Standard Deviation|Mean
819851|NCT01138657|Secondary|Time to Optical Coherence Tomography (OCT) Evidence of Macular Edema in At Least 1 Eye On or After Week 6|"Optical coherence tomography was performed at every visit using 1 of 3 approved machines. Images were evaluated by a central reader. Macular edema was defined as cystoid macular edema.
OCT evidence of macular edema on or after Week 6 was to be counted as an event. Dropouts due to reasons other than OCT evidence of macular edema were to be considered as censored observations at the time of dropping out."|From Baseline until the Final Visit (up to 80 weeks)|Intent to treat population with no macular edema at Baseline||months||Inter-Quartile Range|Median
819852|NCT01138657|Secondary|Change In Logarithm of the Minimum Angle of Resolution (LogMAR) Best Corrected Visual Acuity (BCVA) In Each Eye From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit|Using corrective lenses based on that visit's refraction testing, participant's best corrected visual acuity was measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) logMAR chart.|From Baseline to Week 6 and Final/Early Termination Visit (up to 80 weeks)|Intent-to-treat population with values at both time points; last observation carried forward (LOCF) imputation was used; participants with no values after Week 6 were excluded.||logMAR||Standard Deviation|Mean
819853|NCT01138657|Secondary|Change in Vitreous Haze (VH) Grade in Each Eye From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit|"Vitreous haze was measured using dilated indirect ophthalmoscopy (DIO) and assessed by the Investigator according to National Eye Institute (NEI) and SUN criteria:
Grade 0: No evident vitreous haze;
Grade 0.5+: Slight blurring of the optic disc margin because of the haze; normal striations and reflex of the nerve fiber layer cannot be visualized;
Grade 1+: Permits a better definition of both the optic nerve head and the retinal vessels (compared to higher grades);
Grade 2+: Permits better visualization of the retinal vessels (compared to higher grades);
Grade 3+: Permits the observer to see the optic nerve head, but the borders are quite blurry;
Grade 4+: Optic nerve head is obscured."|From Baseline to Week 6 and Final/Early Termination Visit (up to 80 weeks)|Intent-to-treat population with values at both time points; last observation carried forward (LOCF) imputation was used; participants with no values after Week 6 were excluded.||units on a scale||Standard Deviation|Mean
819854|NCT01138657|Secondary|Change in Anterior Chamber (AC) Cell Grade in Each Eye From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit|"Slit lamp examinations were conducted at each visit to assess AC cell count. The number of AC cells observed within a 1 mm × 1 mm slit beam was used to determine the grade according to the Standardization of Uveitis Nomenclature (SUN) criteria:
Grade 0 = < 1 cell;
Grade 0.5+ = 1-5 cells;
Grade 1+ = 6-15 cells;
Grade 2+ = 16-25 cells;
Grade 3+ = 26-50 cells;
Grade 4+ = > 50 cells."|From Baseline to Week 6 and at the Final/Early Termination Visit (up to 80 weeks)|Intent-to-treat population with values at both time points (best state achieved prior to Week 6 and at least 1 post-week 6 value); last observation carried forward (LOCF) imputation was used; participants with no values after Week 6 were excluded.||units on a scale||Standard Deviation|Mean
819855|NCT01138657|Primary|Time to Treatment Failure on or After Week 6|"Time to treatment failure was analyzed using Kaplan-Meier methods. Treatment failures on or after Week 6 were counted as events. Dropouts for reasons other than treatment failure at any time during the study were censored at the dropout date. To be considered a treatment failure, ≥ 1 of these criteria had to be present in at least 1 eye:
New active, inflammatory chorioretinal or retinal vascular lesions relative to Baseline
Inability to achieve ≤ 0.5+ at Week 6 or a 2-step increase relative to best state achieved at all visits after Week 6 in anterior chamber cell grade or vitreous haze grade
Worsening of best corrected visual acuity by ≥ 15 letters relative to best state achieved.
Per protocol, the primary analysis was performed in the Main Study population which included all randomized participants recruited outside Japan; for completeness results are also reported below for the Integrated dataset which includes participants recruited in Japan."|From Baseline until end of study (up to 80 weeks)|The intent-to-treat (ITT) population which included all randomized participants; 6 participants at 2 sites were excluded from the ITT due to incomplete efficacy source data and compliance issues.||months||Inter-Quartile Range|Median
819856|NCT01138735|Secondary|Change in Inflammatory Lesion Counts From Baseline||Baseline to Week 12 (LOCF)|ITT Population, LOCF||lesion count change||Standard Deviation|Mean
819857|NCT01138735|Secondary|Percent Change in Total Lesion Counts From Baseline||Baseline to Week 12 (LOCF)|ITT Population, LOCF||percentage of change in lesion count||Standard Deviation|Mean
819858|NCT01138735|Primary|Change From Baseline in Total Lesion Counts||Baseline to Week 12 (LOCF)|ITT population, LOCF||lesion count change||Standard Deviation|Mean
819859|NCT01138735|Primary|Success Rate|Percentage of subjects rated Clear or Almost Clear with at least 2 grades reduction from Baseline on the Investigator's Global Assessment (IGA)|Baseline to Week 12 (Last Observation Carried Forward [LOCF])|Intent to treat (ITT) population, LOCF||percentage of participant|||Number
819860|NCT01138826|Secondary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120, and 168 hours post dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||hr||Standard Deviation|Mean
819861|NCT01138826|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120, and 168 hours post dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||hr||Full Range|Median
819862|NCT01138826|Primary|Maximum Observed Plasma Concentration (Cmax)||0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120, and 168 hours post dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng/mL||Full Range|Geometric Mean
819863|NCT01138826|Primary|AUC From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration-time curve from time zero (pre-dose) to the time of the last measurable concentration (AUClast).|0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120, and 168 hours post dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||hr*ng/mL||Full Range|Geometric Mean
819932|NCT01139658|Secondary|Duration Between Surgery and First Dose of Pradaxa||11 weeks|Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.||hours||Standard Deviation|Mean
819864|NCT01138826|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120, and 168 hours post dose|Pharmacokinetic (PK) parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||hr*ng/mL||Full Range|Geometric Mean
819865|NCT01138969|Secondary|Peptic Ulcer Bleeding|participants with peptic ulcer bleeding within 6 months|6 months|Intention to treat||participants|||Number
819866|NCT01138969|Primary|Recurrent Peptic Ulcer|Number of participants with recurrent peptic ulcer within 6 months|6 months|Intention to treat||participants|||Number
819867|NCT01138995|Secondary|User Satisfaction|Total user satisfaction as measured on 12 item User Satisfaction survey with maximum score 24, minimum 0, where higher score indicated greater satisfaction with device,|Week 30|All randomized subjects were analyzed.||units on a scale||Standard Deviation|Mean
819868|NCT01138995|Secondary|Berg Balance Scale (BBS) Score|Clinical measurement of balance was recorded using the Berg Balance Scale which is a highly reliable and valid test used among persons with stroke. This Scale consists of 14 items/tasks of increasing difficulty graded on a five-point ordinal scale of zero to four where zero = participant is unable to perform the task and four = participant is independent in performance of task, such that overall total score may range from zero to 56 per participant. Mean Baseline and Mean Week 30 scores were calculated and used to determine change in mean score for each study group.|Week 30|All randomized subjects are included in this analysis to determine change in mean score from Baseline to Week 30 in each study group.||units on a scale||Standard Deviation|Mean
819869|NCT01138995|Primary|Ten Meter Walk Test (10mWT)|"Determine gait velocity during a 10 meter walk test for subjects using the L300 versus subjects using a standard usual ankle-foot orthosis (AFO). Long term device effect at comfortable gait speed in m/s. Walk test results at 30 weeks will be compared to baseline speed. The mean difference (improvement) between baseline and week 30 will be presented by study arm."|Week 30|Intent to treat analysis of 197 (98 Control and 99 Treatment) randomized subjects.||meters per second (m/s)||Standard Deviation|Mean
819870|NCT01139008|Secondary|6 Question Subject Preference Survey at Week 3|Number of participants per response to each question of the Subject Preference Survey at week 3|week 3|Safety||participants|||Number
819871|NCT01139008|Secondary|Number of Participants Who Were a Success With Regard to Worst-baseline Tolerability Assessment Scores in Each Assessment (Erythema, Scaling, Dryness, Stinging/Burning) on Day 22.|Number of participants who were a success with regard to worst-baseline tolerability assessment scores for each assessment (erythema, scaling, dryness, stinging/burning) on day 22. Tolerability assessments (erythema, scaling, dryness, stinging/burning) are evaluated on a scale from 0 - 4 (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) with 0 being best and 4 being worst. Success was defined as a tolerability score of 0 for each assessment.|Day 22|Safety||participants|||Number
819872|NCT01139008|Primary|Number of Participants Who Were a Success With Regard to Worst Post-baseline Tolerability Assessment Scores in Each Assessment (Erythema, Scaling, Dryness, Stinging/Burning) From Baseline to Week 3|Number of participants who were a success with regard to worst post-baseline tolerability assessment scores in each of the tolerability assessments at any time point between baseline and week 3. Tolerability assessments (erythema, scaling, dryness, stinging/burning) are evaluated on a scale from 0 - 4 (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) with 0 being best and 4 being worst. Success was defined as a tolerability score of 0.|baseline to week 3|Safety||participants|||Number
819873|NCT01139021|Secondary|Number of Subjects Reporting Unsolicited Adverse Events After Receiving Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age.|To assess the safety and tolerability in terms of number of subjects reporting unsolicited adverse events after receiving two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age. The analysis was done on safety subset.|Up to 7 days after any vaccination|The analysis was done on safety subset.||Number of Subjects|||Number
819874|NCT01139021|Secondary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age.|To assess the safety and tolerability by reporting solicited local and systemic adverse events of two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.|Up to 7 days after any vaccination.|The analysis was done on safety subset.||Number of subjects|||Number
819875|NCT01139021|Secondary|Number of Subjects Reporting Unsolicited Adverse Events After Receiving a Booster (3rd) Dose of rMenB+OMV NZ Administered at One Year After Two Catch-up Doses of rMenB+OMV NZ, Previously Administered to Children.|To assess the safety and tolerability in terms of number of subjects reporting unsolicited adverse events in yerms of serious adverse events (SAEs), atleast possibly related SAEs and AEs leading to withdrawl of a booster (third) dose of rMenB+OMV NZ administered at one year after two catch-up doses of rMenB+OMV NZ, previously administered to children at either 12 and 14 or 13 and 15 months of age in study V72P13E1.|Up to 7 days after any vaccination.|The analysis was done on safety subset.||Number of Subjects|||Number
819876|NCT01139021|Secondary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) After Receiving a Booster (Third) Dose of rMenB+OMV NZ Administered at One Year After Two Catch-up Doses of rMenB+OMV NZ, Previously Administered to Children.|To assess the safety and tolerability by reporting solicited local and systemic AEs of a booster (third) dose of rMenB+OMV NZ administered at one year after two catch-up doses of rMenB+OMV NZ, previously administered to children at either 12 and 14 or 13 and 15 months of age in study V72P13E1.|Up to 7 days after any vaccination.|||Number of subjects|||Number
819877|NCT01139021|Secondary|GMCs to Assess Antibody Response at 1 Month and 6 Month Post Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age Against 287-953 Strain.|"To assess the immunogenicity in terms of GMCs to assess through antibody response at 1 month and 6 month post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age against 287-953 strain.
Analysis was done on MITT population (Secondary)."|1 month and 6 months post two catch-up doses.|Analysis was done on MITT population (Secondary).||Concentration IU/mL||95% Confidence Interval|Geometric Mean
819933|NCT01139658|Secondary|Dosage of Pradaxa at Initiation||Baseline|Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.||participants|||Number
819878|NCT01139021|Secondary|Percentage of Subjects With Four Fold Increase in hSBA to Assess Antibody Response at 1 Month Post Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age.|"To assess the immunogenicity in terms of percentage of subjects with fourfold increases in hSBA titers at 1 month post two catch-up doses of rMenB+OMV NZ in children previously administered to naive children at 24 and 26 months of age against 4 strains.
Analysis was done on MITT population (Secondary)."|1 month post two catch-up doses versus prevaccination|Analysis was done on MITT population (Secondary).||Percentage of subjects||95% Confidence Interval|Number
819879|NCT01139021|Secondary|Percentage of Subjects With hSBA ≥1:5 and hSBA ≥1:8 to Assess Antibody Response at 1 Month and 6 Month Post Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age.|To assess the immunogenicity in terms of percentage of subjects with hSBA ≥1:5 and hSBA ≥1:8 through antibody response at at 1 month and 6 month post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.|1 month and 6 months post two catch-up doses.|Analysis was done on MITT population (Secondary)||Percentage of subjects||95% Confidence Interval|Number
819880|NCT01139021|Secondary|GMTs to Characterize Antibody Response at 1 Month and 6 Month Post Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age.|To assess the immunogenicity in terms of GMTs through antibody response at 1 month and 6 month post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.|1 month and 6 months post two catch-up doses.|Analysis was done on MITT population (Secondary).||Titers||95% Confidence Interval|Geometric Mean
819881|NCT01139021|Secondary|GMCs to Assess Antibody Persistence at One Year After Two Catch-up Doses and 6 Months After Booster of rMenB+OMV NZ Vaccination Against 287-953 Strain.|"To assess the immunogenicity in terms of GMCs determined by ELISA at 12 months after two catch up doses previously administered to children at either 12 and 14 or 13 and 15 months of age and 6 months after a booster dose of rMenB+OMV NZ administered at 26 or 27 months of age.
Both the groups received MMRV at 12 months of age."|12 months post two catch-up dose vaccination and 6 months post booster dose.|Analysis was done on MITT population (Secondary).||Concentration IU/mL||95% Confidence Interval|Geometric Mean
819882|NCT01139021|Secondary|Percentage of Subjects With at Least Four Fold Increase in hSBA Titers to Evaluate Antibody Response 1 Month Post Booster Dose of rMenB+OMV NZ Vaccination.|To assess the immunogenicity in terms of percentage of subjects with at least four fold increase in hSBA titers 1 month post booster dose of rMenB+OMV NZ administered at 26 or 27 months of age, in children previously administered two catch-up doses of rMenB+OMV NZ at either 12 and 14 or 13 and 15 months of age.Both the groups received MMRV at 12 months of age.|1 month post booster dose versus prebooster.|Analysis was done on MITT population (Secondary).||Percentage of Subjects||95% Confidence Interval|Number
819883|NCT01139021|Secondary|Percentage of Subjects With hSBA ≥1:5 and hSBA ≥1:8 to Assess Antibody Persistence at 12 Months After Two Catch up Doses and 6 Months After a Booster Doses of rMenB+OMV NZ Vaccination.|"To assess the immunogenicity in terms of percentage of subjects with hSBA ≥1:5 and hSBA ≥1:8 at 12 months after two catch up doses previously administered to children at either 12 and 14 or 13 and 15 months of age and 6 months after a booster dose of rMenB+OMV NZ administered at 26 or 27 months of age.
Both the groups received MMRV at 12 months of age."|6month post booster dose and 12 months post two catch-up dose vaccination.|Analysis was done on MITT population (Secondary).||Percentage of subjects||95% Confidence Interval|Number
819884|NCT01139021|Secondary|GMTs to Assess Antibody Persistence at 12 Months After Two Catch-up Doses and 6 Months After Booster Dose of rMenB+OMV NZ Vaccination.|"To assess the immunogenicity in terms of hSBA GMTs at 12 months after two catch up doses previously administered to children at either 12 and 14 or 13 and 15 months of age and 6 months after a booster dose of rMenB+OMV NZ administered at 26 or 27 months of age.
Both the groups received MMRV at 12 months of age."|12 months post two catch-up dose vaccination and 6 months post booster dose.|Analysis was done on MITT population (Secondary).||Titers||95% Confidence Interval|Geometric Mean
819885|NCT01139021|Primary|Geometric Mean Concentrations (GMCs) to Assess Antibody Persistence at One Year After a Booster Dose of rMenB+OMV NZ Vaccination.|"To assess the immunogenicity in terms of GMCs determined by Enzyme Linked Immunosorbent Assay (ELISA) through antibody persistence at one year after a booster (fourth) dose of rMenB+OMV NZ in groups that received a three-dose primary series at 2, 4, 6 months of age. Group B246_12M12 received MMRV at 12 months of age (concomitantly) and group B246_12M13 received MMRV at 13 months of age (separately) against vaccine antigen 287-953.
Analysis was done on MITT population (Primary)."|12 months post booster (fourth) vaccination.|Analysis was done on MITT population (Primary).||Concentration IU/mL||95% Confidence Interval|Geometric Mean
819886|NCT01139021|Primary|Percentage of Subjects With hSBA ≥1:5 and hSBA ≥1:8 to Assess Antibody Persistence at on 12 Months After a Booster Dose of rMenB+OMV NZ Vaccination.|"To assess the immunogenicity in terms of percentage of subjects with hSBA ≥1:5 and hSBA ≥1:8 through antibody persistence at 12 months after a booster (fourth) dose of rMenB+OMV NZ in groups that received a three-dose primary series at 2, 4, 6 months of age. Group B246_12M12 received MMRV at 12 months of age (concomitantly) and group B246_12M13 received MMRV at 13 months of age (separately).
Analysis was done on MITT population (Primary)."|12 months post booster (fourth) vaccination.|Analysis was done on MITT population (Primary).||Percentage of subjects||95% Confidence Interval|Number
819887|NCT01139021|Primary|Geometric Mean Titers (GMTs) to Assess Antibody Persistence at 12 Months After a Booster Dose of rMenB+OMV NZ Vaccination.|"To assess the immunogenicity in terms of human Serum Bactericidal Assay (hSBA) GMTs through antibody persistence at 12 months after a booster (fourth) dose of Novartis Meningococcal B Recombinant Vaccine (rMenB+OMV NZ) in groups that received a three-dose primary series at 2, 4,6 months of age. Group B246_12M12 received Measles, Mumps, Rubella, Varicella (MMRV) at 12 months of age (concomitantly) and group B246_12M13 received MMRV at 13 months of age (separately).
Analysis was done on Modified Intention-To-Treat (MITT) population- (Primary)."|12 months post booster (fourth) vaccination.|Analysis was done on Modified Intention-To-Treat (MITT) population (Primary).||Titers||95% Confidence Interval|Geometric Mean
819888|NCT01139047|Secondary|6 Question Subject Preference Survey at Week 3|Number of participants per response to each question of the subject preference survey at week 3|3 weeks|Safety||participants|||Number
819952|NCT01139879|Secondary|Healing Rate Per Week|The mean change in area per week for all ulcers|12 weeks|Rate of change in area (healing) for all ulcers on all subjects in area (cm^2)/week||cm^2/week|Participants|Standard Deviation|Mean
819953|NCT01139879|Secondary|Incidence of New Ulcers|incidence of new ulcers while on the study surface|12 Weeks|||percentage of participants|||Number
819889|NCT01139047|Secondary|Number of Participants Who Were a Success With Regard to Worst-baseline Tolerability Assessment Scores in Each Assessment (Erythema, Scaling, Dryness, Stinging/Burning) on Day 22|Number of participants who were a success with regard to worst-baseline tolerability assessment scores for each assessment (erythema, scaling, dryness, stinging/burning) on day 22. Tolerability assessments (erythema, scaling, dryness, stinging/burning) are evaluated on a scale from 0 - 4 (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) with 0 being best and 4 being worst. Success was defined as a tolerability score of 0 for each assessment.|day 22|||participants|||Number
819890|NCT01139047|Primary|Number of Participants Who Were a Success With Regard to Worst Post-baseline Tolerability Scores in Each Assessment (Erythema, Scaling, Dryness, Stinging/Burning) From Baseline to Week 3|Number of participants who were a success with regard to worst post-baseline tolerability scores in each of the tolerability assessments at any time point between baseline and week 3. Tolerability assessments (erythema, scaling, dryness, stinging/burning) are evaluated on a scale from 0 - 4 (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) with 0 being best and 4 being worst. Success was defined as a tolerability score of 0.|baseline to week 3|Safety||participants|||Number
819891|NCT01139125|Primary|Safety and Efficacy|We are measuring if this medication is appropriate for use in schizophrenia patients.|4 months||||||
819892|NCT01139164|Secondary|Morbidity of Allogeneic Stem Cell Transplants|To determine the morbidity, including the pattern and severity of complications, of allogeneic stem cell transplants using reduced-intensity conditioning regimens. The average number of days spent in the hospital until day +100 will be reported as a surrogate for morbidity and complications.|100 days|This study terminated early; funding ran out before the analysis could be completed.|||||
819893|NCT01139164|Secondary|To Determine the Engraftment Rate of Allogeneic Stem Cell Transplants|To determine the engraftment rate of allogeneic stem cell transplants using reduced-intensity conditioning regimens. It will be measured as the proportion of subjects meeting criteria for engraftment before day +30 and full donor chimerism demonstrated before or at day +100. Engraftment is defined by maintenance of ANC > 500/mm3 for at least 3 consecutive days and platelet count > 20,000/mm3 for 3 consecutive days in absence of platelet transfusion. These criteria must have been met before Day +30. Chimerism is the pressence of donor cells and will be analyzed by FISH for sex-mismatched donor-recipient pairs and VNTR analysis for sex-mathced pairs. Chimerism by Day +100 will be documented for this outcome|Day +100|The outcome measure data below only accounts for the number of subjects who met the engraftment criteria prior at day +30; the chimerism data was not collected. For regimen B, only the subjects who participated in study intervention were analyzed for outcome measures.||participants|||Number
819894|NCT01139164|Primary|To Determine the Treatment-related Mortality Rate of Allogeneic Stem Cell Transplants Using Reduced-intensity Conditioning Regimens Within 1st 100-days.|Number of subject deaths prior to day 100.|8 years|For regimen B, only the subjects who participated in study intervention were analyzed for outcome measures.||participants|||Number
819895|NCT01139190|Primary|Degree of GI Injury at Day 15|"Degree of mucosal injury was assessed by endoscopy, with the following scoring system:
Score 0: No Injury Score 1: 1 to 10 petechiae Score 2: > 10 petechiae or 1 to 5 erosions Score 3: 6 to 10 erosions Score 4: > 10 erosions and/or an ulcer"|15 days|Per Protocol Population: subset of participants who had an endoscopy performed at Day 15 reviewed by both blinded endoscopists, was at least 85% compliant with taking the study drug (based on pill counts), who took the final dose drug on the day of the second endoscopy, and who had no other protocol violations that would affect assessments.||participants|||Number
819896|NCT01139294|Secondary|Gorelick Assessment|"Gorelick assessment of hydration status at baseline, and at the end of sub-q or IV hydration treatment or at discharge from the emergency dept.
volume of fluid infuse over time
time to discharge from ED to home or transfer into the hospital
discharge diagnosis from ED
duration of any supplemental hospitalization for supplemental hydration
time to first urine output observed
requirement for rescue therapy and nature of the rescue therapy
incidence of readmission to hospital/ED
global assessment of overall satisfaction with rehydration therapy by parents and caregiver"|Measurements and data are recorded only while patient is receiving care in the ED. A f/u call is made on day 3 and/or day 7 post enrollment into the study.|No outcome measure data available. Study data was lost.Data was left behind when PI left institution in 2013. Unable to find anyone with knowledge of data location.|||||
819897|NCT01139294|Primary|Cardiac Output Trends|Describe the cardiac output trends measured in liters per minute (onset and changes in slope over time) by noninvasively monitoring methods in pediatric patients being rehydrated by Hylenex augmented subcutaneous rehydration or routine IV rehydration|Measurements and data are recorded only while patient is receiving care in the Emergency Department (ED). A f/u call is made on day 3 and/or day 7 post enrollment into the study.|No outcome measure data available. Study data was lost. Data was left behind when PI left institution in 2013. Unable to find anyone with knowledge of data location.|||||
819898|NCT01139411|Secondary|Communication 2: Observed Parent-adolescent Communication Quality (DOCS)|Post-treatment value (controlling for baseline). Observed parent-adolescent communication quality was measured using the Dyadic Observed Communication Scale (DOCS) used to code communication between adolescent and caregiver during a video-taped observational coding session. The DOCS is coded on a scale of 0 -10, with higher scores reflecting higher quality of communication, as observed by an independent rater. Higher scores are thought to reflect a better treatment outcome.|Baseline to post-treatment|38 participants (19 in each group) had complete baseline and post treatment data for videotaped observations.||units on a scale||Standard Deviation|Mean
819899|NCT01139411|Secondary|Communication 1: Negative Maternal Weight-related Commentary (FERF-Q)|Post-treatment value (controlling for baseline). Negative maternal weight-related commentary was assessed using the Negative maternal weight-related commentary subscale of the Family Experiences Related to Food Questionnaire (FERF-Q)), an adolescent-report measure of parent behavior pertaining to weight control. The Negative maternal weight-related commentary subscale of the FERF-Q has a scale range of 1 - 5, with higher scores corresponding to greater negative maternal weight-related commentary, as perceived and reported by the adolescent. Lower scores are considered a better treatment outcome.|Baseline to post-treatment|Secondary outcomes analyzed for treatment completers only||units on a scale||Standard Deviation|Mean
819954|NCT01139879|Primary|Change From Baseline in Ulcer Surface Area at Week 12|The primary outcome measure for this study is to be healing rate by area, based on the identified target study ulcer.|12 Weeks|Ulcers decreased an average of 7.96 cm^2 (+/- 8.1 cm^2) over the 12 week period||cm^2|Participants|Standard Deviation|Mean
819900|NCT01139411|Secondary|Parent Modeling 4: Weight and Body Concerns (FERF-Q)|Post-treatment value (controlling for baseline). Parent modeling of concern about weight/body was assessed using the Parent Modeling of Weight and Body Concerns subscale of the Family Experiences Related to Food Questionnaire (FERF-Q)), an adolescent-report measure of parent behavior pertaining to weight control. The Weight and Body Concerns subscale of the FERF-Q has a scale range of 1 - 5, with higher scores corresponding to greater parent weight and body concerns, as perceived and reported by the adolescent. Lower weight and body concern is considered a better treatment outcome.|Baseline to post-treatment|Secondary outcomes analyzed for treatment completers only||units on a scale||Standard Deviation|Mean
819901|NCT01139411|Secondary|Parent Modeling 3: Physical Activity (WCSS)|Post-treatment value (controlling for baseline). Parent modeling of Physical Activity was assessed using the Physical Activity subscale of the Weight Control Strategies Scale (WCSS), a parent-report measure of his/her own healthy weight control practices. The Physical Activity subscale of the WCSS has a scale range of 0-4, with higher scores corresponding to greater physical activity. Higher scores are considered a better treatment outcome.|Baseline to post-treatment|Secondary outcomes analyzed for treatment completers only||units on a scale||Standard Deviation|Mean
819902|NCT01139411|Secondary|Parent Modeling 2: Self-monitoring (WCSS)|Post-treatment value (controlling for baseline). Parent modeling of self-monitoring behavior was assessed using the Self Monitoring subscale of the Weight Control Strategies Scale (WCSS), a parent-report measure of his/her own healthy weight control practices. The Self Monitoring subscale of the WCSS has a scale range of 0 - 4, with higher scores corresponding to more self-monitoring behavior. Higher scores are thought to reflect a better treatment outcome.|Baseline to post-treatment|Secondary outcomes analyzed for treatment completers only.||units on a scale||Standard Deviation|Mean
819903|NCT01139411|Secondary|Parent Modeling 1: Dietary Choices (WCSS)|Post-treatment value (controlling for baseline). Parent modeling of dietary choices was assessed using the Diet Choices subscale of the Weight Control Strategies Scale (WCSS), a parent-report measure of his/her own healthy weight control practices. The Dietary choices subscale of the WCSS has a scale range of 0 - 4, with higher scores corresponding to healthier diet choices. Higher scores are considered to be a better treatment outcome.|Baseline to post-treatment|Secondary outcomes analyzed for treatment completers only.||units on a scale||Standard Deviation|Mean
819904|NCT01139411|Primary|Body Mass Index|Post-treatment BMI (controlling for baseline BMI)|Baseline and at completion of 16 week intervention|||kilograms/meters squared||Standard Deviation|Mean
819905|NCT01139450|Secondary|The Mean Change From Baseline in the Percentage Total Body Surface Affected (%BSA)||Baseline, 4 weeks||||||
819906|NCT01139450|Secondary|The Mean Change From Baseline in Pruritus||Baseline, 4 weeks||||||
819907|NCT01139450|Secondary|The Mean Change From Baseline in the Total Individual Clinical Signs and Symptoms Per Body Region||Baseline, 4 weeks||||||
819908|NCT01139450|Primary|Incidence of Success Based on the Investigator’s Global Evaluation at the End of Treatment||4 weeks|||participants|||Number
819909|NCT01139515|Secondary|Plasma Decay Half Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose (D)|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||Hr||Standard Deviation|Mean
819910|NCT01139515|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose (D)|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||Hr||Full Range|Median
819911|NCT01139515|Primary|Maximum Observed Plasma Concentration (Cmax)||Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose (D)|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng/mL||Full Range|Geometric Mean
819912|NCT01139515|Primary|AUC From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration-time curve from time zero (pre-dose) to the time of the last measurable concentration (AUClast).|Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose (D)|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng*hr/mL||Full Range|Geometric Mean
819913|NCT01139515|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose(D)|Pharmacokinetic (PK) parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng* hr/mL||Full Range|Geometric Mean
819914|NCT01139580|Secondary|Number of Participants With an ISGA Score of Clear (0) or Almost Clear (1) for Body Involvement at Week 8|The investigator assessed participants with psoriasis with body involvement using the ISGA, scored as: 0, clear, minor residual discoloration, no erythema, scaling, or plaque thickness; 1, almost clear, occasional fine scale, faint erythema, and barely perceptible plaque thickness; 2, mild, fine scales predominate with light-red coloration and mild plaque thickness; 3, moderate, coarse scales predominate with moderate red coloration and plaque thickness; 4 severe, thick tenacious scale predominates with deep red coloration and severe plaque thickness. Scores are a visual average of lesions.|Week 8|ITT Population. Data were analyzed using the failure and LOCF methods.||participants|||Number
819955|NCT01139996|Secondary|Mean Incidence and Duration of Delirium|As assessed by daily CAM score currently used. data were not collected|2 or more years||||||
819956|NCT01139996|Secondary|Time to Pass First SBT Following Administration of the First Dose of Clonidine or Placebo|Hours. data were not collected|2 or more years||||||
819957|NCT01139996|Secondary|Incidence and Duration in Hours of Delirium Currently Used|As assessed by the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) score Data were not collected|2 or more years||||||
819915|NCT01139580|Secondary|Number of Participants With a Target Lesion Score of 0 or 1 for Plaque Thickness at Week 8|Psoriasis is a noncontagious skin disorder, most often appearing as inflamed, thickened skin covered with silvery white scales on the scalp, trunk, and limbs. The investigator assessed participants with plaque thickness at target lesions using the PGSTL scores: 0, no elevation over normal skin; 1, possible but difficult to ascertain whether there is a slight elevation above normal skin; 2, slight but definite elevation, edges are indistinct or sloped; 3, moderate elevation with rough or sloped edges; 4, marked elevation with hard or sharp edges; 5, very marked elevation with hard sharp edges.|Baseline and Week 8|ITT Population||participants|||Number
819916|NCT01139580|Primary|Number of Participants With an ISGA Score of Clear (0) or Almost Clear (1) for Scalp Involvement at Week 8 Using Last Observation Carried Forward (LOCF)|The investigator assessed participants with scalp psoriasis using the ISGA, scored as (as a visual average of lesions): 0, absence of disease; 1, very mild disease, lesions (L) with minimum erythema; 2, mild disease, L with light-red coloration, slight thickness, and fine, thin scale layer; 3, moderate disease, L with red coloration, moderate thickness, and a moderate scaled layer; 4, severe disease, L with red coloration, severe thickness, and a severe coarse, thick scale layer; 5, very severe disease, L with red coloration, very severe thickness, and a very severe, coarse, thick scale layer.|Week 8|ITT Population. Missing values were imputed using LOCF (i.e., the last available observation, including Baseline, for a participant will be used to estimate subsequent missing data points).||participants|||Number
819917|NCT01139580|Secondary|Number of Participants With a Target Lesion Score of 0 or 1 for Scaling and at Least a 2 Grade Improvement From Baseline at Week 8|Scaling of the skin is the loss of the outer layer of the epidermis in scale-like flakes. The investigator assessed participants with scaling at target lesions using the psoriasis grading scale for target lesions (PGSTL). PGSTL scores: 0, no evidence of scaling; 1, minimal, occasional fine scale over less than 5% of the lesion; 2, mild, fine scales predominate; 3, moderate, coarse scales predominate; 4 marked, thick non-tenacious scale predominates; 5 severe, very thick tenacious scale predominates.|Baseline and Week 8|ITT Population||participants|||Number
819918|NCT01139580|Secondary|Number of Participants With a Target Lesion Score of 0 or 1 for Erythema and at Least a 2 Grade Improvement From Baseline at Week 8|Erythema is redness of the skin, caused by increased blood flow in the capillaries in the lower layers of the skin. The investigator assessed participants with erythema at target lesions using the psoriasis grading scale for target lesions (PGSTL). PGSTL scores: 0, no evidence of erythema, hyperpigmentation may be present; 1, faint erythema; 2, light-red coloration; 3, moderate red coloration; 4, bright-red coloration; 5, dusky to deep red coloration.|Baseline and Week 8|ITT Population||participants|||Number
819919|NCT01139580|Primary|Number of Participants With an Investigator’s Static Global Assessment (ISGA) Score of Clear (0) or Almost Clear (1) for Scalp Involvement at Week 8 Using the Failure Method|The investigator assessed participants with scalp psoriasis using the ISGA, scored as (as a visual average of lesions): 0, absence of disease; 1, very mild disease, lesions (L) with minimum erythema; 2, mild disease, L with light-red coloration, slight thickness, and fine, thin scale layer; 3, moderate disease, L with red coloration, moderate thickness, and a moderate scaled layer; 4, severe disease, L with red coloration, severe thickness, and a severe coarse, thick scale layer; 5, very severe disease, L with red coloration, very severe thickness, and a very severe, coarse, thick scale layer.|Week 8|Intent-to-Treat (ITT) Population: all participants who were randomized and dispensed study product. Missing values at Week 8 were considered to be failures. Failures were those participants who did not achieve a 2-grade improvement in IGSA score and a score of 0 or 1.||participants|||Number
819920|NCT01139658|Secondary|Reasons for Usual Follow-up||11 weeks|Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.||participants|||Number
819921|NCT01139658|Secondary|Reasons for Unplanned Hospitalizations at Visit 3||11 weeks|Outcome measure was not analyzed.|||||
819922|NCT01139658|Secondary|Duration of Unplanned Hospitalizations at Visit 3||11 weeks|Outcome measure was not analyzed.|||||
819923|NCT01139658|Secondary|Frequency of Nurse Visits on the Day of Hospital Discharge||11 weeks|Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.||times per week||Standard Deviation|Mean
819924|NCT01139658|Secondary|Reasons for Nurse Visits on the Day of Hospital Discharge||11 weeks|Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.||participants|||Number
819925|NCT01139658|Secondary|Prescription for Nursing Care and Nurse Visits on the Day of Hospital Discharge||11 weeks|Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.||participants|||Number
819926|NCT01139658|Secondary|Prescription for the Surveillance of the Platelet Count on the Day of Hospital Discharge||11 weeks|Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.||participants|||Number
819927|NCT01139658|Secondary|Number of Patients Who Switched to Another Anticoagulant Therapy|Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.|11 weeks|||participants|||Number
819928|NCT01139658|Secondary|Concomitant Treatments|Concomitant treatments prescribed at hospital discharge.|11 weeks|Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.||participants|||Number
819929|NCT01139658|Secondary|Adherence to Treatment|The adherence to treatment was measured by patient declaration.|11 weeks|Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.||percent||Standard Deviation|Mean
819930|NCT01139658|Secondary|Proportion of Patients With a Preoperative ALT Measurement||11 weeks|Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.||percentage of participants|||Number
819958|NCT01139996|Primary|Duration of Mechanical Ventilation Following Administration of the First Dose of Clonidine or Placebo|data were not collected|2 or more years|data were not collected|||||
819934|NCT01139658|Primary|Occurrence of Major Bleeding Events|"Occurrence of major bleeding events (MBEs) in patients treated with Pradaxa (dabigatran etexilate) after orthopaedic surgery (either THR or TKR surgery). MBEs were defined as any fatal haemorrhage, any overt bleeding greater than could be expected combined with a loss of haemoglobin ≥ 2 g/dL or requiring transfusion ≥ 2 packed red blood cells units (PRBC), any symptomatic retroperitoneal, intracranial, intraocular or intraspinal haemorrhage or any bleeding requireing treatment cessation or reoperation.
a confirmed proximal or distal deep vein thrombosis (DVT) or a confirmed pulmonary emboliam (PE)."|11 weeks|Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.||participants|||Number
819935|NCT01139658|Primary|Occurrence of Symptomatic Venous Thromboembolic Events|Occurrence of symptomatic venous thromboembolic (VTE) events in patients treated with Pradaxa (dabigatran etexilate) after orthopaedic surgery (either Total Hip Replacement (THR) or Total Knee Replacement surgery (TKR)). Symptomatic VTE events were defined as a confirmed proximal or distal deep vein thrombosis (DVT) or a confirmed pulmonary embolism (PE).|11 weeks|Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.||participants|||Number
819936|NCT01139762|Secondary|Change in International Index of Erectile Function (IIEF) Question 3 and 4 Scores From Baseline to 4, 12, and 26 Weeks|IIEF Question 3 asks how often a participant was able to penetrate his partner over the past 4 weeks. Scores range from 0 (did not attempt intercourse) to 5 (almost always or always). IIEF Question 4 asks whether/how often a participant was able to maintain an erection after penetration over the past 4 weeks. Scores range from 0 (did not attempt intercourse) to 5 (almost always or always). Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline IIEF, and visit-by-treatment interaction.|Baseline, 4 weeks, 12 weeks, 26 weeks|All randomized participants who received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IIEF Questions 3 and 4 measurement.||units on a scale||Standard Error|Least Squares Mean
819937|NCT01139762|Secondary|Change in Post Void Residual (PVR) Volume From Baseline to 26 Weeks|Postvoid Residual Volume (PVR) is determined using a portable, calibrated ultrasound device. It consists of the average of a minimum of 3 scans where the residual bladder volume was calculated by averaging the most accurate of the 3 imaging attempts.|Baseline, 26 weeks|All randomized participants who received at least 1 dose of the study drug, had baseline and at least 1 post-baseline PVR measurement.||milliliters (mL)||Standard Deviation|Mean
819938|NCT01139762|Secondary|Clinician Global Impression of Improvement (CGI-I) at 26 Weeks|Clinician Global Impression of Improvement (CGI-I) measures clinician's perception of participant improvement at the time of assessment compared with the start of treatment. Number of participants is reported by the categorized score ranging from 1 (very much better) to 7 (very much worse).|26 weeks|All randomized participants who received at least 1 dose of the study drug and had CGI-I measurement at 26 weeks endpoint.||participants|||Number
819939|NCT01139762|Secondary|Treatment Satisfaction Scale - Benign Prostatic Hyperplasia (TSS-BPH) at 26 Weeks|The TSS-BPH was a validated participant-rated instrument that measured participant satisfaction with treatment based on a 13-item questionnaire. It consists of 10 items on a Likert-like scale with scores ranging from 1 (higher satisfaction) to 5 (lower satisfaction), 1 item with score ranging from 0 (higher satisfaction) to 5 (lower satisfaction), and 2 yes/no questions. The mean score for each participant ranges from 0.9 (higher satisfaction) to 5.0 (lower satisfaction). Data presented are the average of mean scores for each treatment group.|26 weeks|All randomized participants who received at least 1 dose of the study drug and had TSS-BPH measurement at 26 weeks endpoint.||units on a scale||Standard Deviation|Mean
819940|NCT01139762|Secondary|Patient Global Impression of Improvement (PGI-I) at 26 Weeks|Patient Global Impression of Improvement (PGI-I) measures the participant's perception of improvement at the time of assessment compared with the start of treatment. Number of participants is reported by the categorized score ranging from 1 (very much better) to 7 (very much worse).|26 weeks|All randomized participants who received at least 1 dose of the study drug and had PGI-I measurement at 26 weeks endpoint.||participants|||Number
819941|NCT01139762|Secondary|Change in International Index of Erectile Function (IIEF) - Sexual Desire Domain Scores From Baseline to 4, 12, and 26 Weeks|Sexual desire domain scores is the sum of Questions 11 and 12 from the IIEF questionnaire. Scores range from 1 (low/no desire) to 5 (high desire) for each question, with the total possible score for the 2 questions ranging from 2 to 10. Higher total scores indicate higher desire. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline IIEF, and visit-by-treatment interaction.|Baseline, 4 weeks, 12 weeks, 26 weeks|All randomized participants who were sexually active with female partner and had erectile dysfunction (ED), received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IIEF-sexual desire domain score measurement.||units on a scale||Standard Error|Least Squares Mean
819942|NCT01139762|Secondary|Change in International Index of Erectile Function (IIEF) - Orgasmic Function Domain Scores From Baseline to 4, 12, and 26 Weeks|Orgasmic Function domain scores is the sum of Questions 9 and 10 from the IIEF questionnaire. Scores range from 0 (low/no orgasm) to 5 (high orgasm) for each question, with the total possible score for the 2 questions ranging from 0 to 10. Higher total scores indicate higher orgasm. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline IIEF, and visit-by-treatment interaction.|Baseline, 4 weeks, 12 weeks, 26 weeks|All randomized participants who were sexually active with female partner and had erectile dysfunction (ED), received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IIEF-orgasmic function domain score measurement.||units on a scale||Standard Error|Least Squares Mean
819959|NCT01140048|Secondary|Percentage of Participants With Use of Chronic Asthma Therapy at 6 Years of Age: Overall and by Prognostic Factor|"Use of Chronic Asthma Therapy for the period of 12 months prior to the age of 6 years was defined by clinical review of reported concomitant medications.
Prognostic factors for use of chronic asthma therapy at age 6 years were derived from baseline characteristic, disease characteristic and family history data, and were identified by a forward stepwise regression model."|At 6 years of age|All Enrolled Participants for whom data on concomitant asthma therapy at age 6 years and prognostic factors were available.||percentage of participants|||Number
819943|NCT01139762|Secondary|Change in International Index of Erectile Function (IIEF) - Intercourse Satisfaction Domain Scores From Baseline to 4, 12, and 26 Weeks|Self-reported intercourse satisfaction over the past 4 weeks. IIEF-intercourse satisfaction is the sum of Questions 6, 7 and 8 of the IIEF. Scores range from 0 (low/no satisfaction) to 5 (high satisfaction) for each question, with the total possible score for the 3 questions of 0 to 15. Higher total scores indicate higher satisfaction. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline IIEF, and visit-by-treatment interaction.|Baseline, 4 weeks, 12 weeks, 26 weeks|All randomized participants who were sexually active with female partner and had erectile dysfunction (ED), received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IIEF-intercourse satisfaction measurement.||units on a scale||Standard Error|Least Squares Mean
819944|NCT01139762|Secondary|Change in International Index of Erectile Function (IIEF) - Overall Satisfaction Domain Scores From Baseline to 4, 12, and 26 Weeks|Self-reported overall satisfaction over the past 4 weeks. IIEF-Overall Satisfaction is the sum of Questions 13 and 14 of IIEF questionnaire. Scores range from 1 (low/no satisfaction) to 5 (high satisfaction) for each question, with the total possible score for the 2 questions ranging from 2 to 10. Higher total scores indicate higher satisfaction. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline IIEF, and visit-by-treatment interaction.|Baseline, 4 weeks, 12 weeks, 26 weeks|All randomized participants who were sexually active with female partner and had erectile dysfunction (ED), received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IIEF-Overall Satisfaction measurement.||units on a scale||Standard Error|Least Squares Mean
819945|NCT01139762|Secondary|Change in International Index of Erectile Function (IIEF) - Erectile Function Domain Scores From Baseline to 4, 12, and 26 Weeks|Self-reported erectile function over the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline IIEF, and visit-by-treatment interaction.|Baseline, 4 weeks, 12 weeks, 26 weeks|All randomized participants who were sexually active with female partner and had erectile dysfunction (ED), received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IIEF-EF measurement.||units on a scale||Standard Error|Least Squares Mean
819946|NCT01139762|Secondary|Change in International Prostate Symptom Score (IPSS) Quality of Life Index From Baseline to 4, 12, and 26 Weeks|"IPSS Quality of Life Index assesses participant response to the following question: If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that? Response options are Delighted (0); Pleased (1); Mostly satisfied (2); Mixed-about equally satisfied and dissatisfied (3); Mostly dissatisfied (4); Unhappy (5); Terrible (6), with a total range of 0-6. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline total IPSS, and visit-by-treatment interaction."|Baseline, 4 weeks, 12 weeks, 26 weeks|All randomized participants who received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IPSS quality of life measurement.||units on a scale||Standard Error|Least Squares Mean
819947|NCT01139762|Secondary|Change in International Prostate Symptom Score (IPSS) Subscores Index From Baseline to 4, 12, and 26 Weeks|IPSS storage (irritative) subscore is the sum of Questions 2, 4 and 7 of the 7-component IPSS questionnaire. Scores range from 0 (no irritative symptoms) to 5 (frequent irritative symptoms), with total subscore of the 3 questions for irritative subscore range from 0 to 15. IPSS voiding (obstructive) subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 0 (no obstructive symptoms) to 5 (frequent obstructive symptoms), with total subscore of the 4 questions of the obstructive score range from 0 to 20. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline total IPSS, and visit-by-treatment interaction.|Baseline, 4 weeks, 12 weeks, 26 weeks|All randomized participants who received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IPSS subscore measurement.||units on a scale||Standard Error|Least Squares Mean
819948|NCT01139762|Secondary|Change in Total International Prostate Symptom Score (IPSS) From Baseline to 4 and 26 Weeks|The International Prostate Symptom Score (IPSS) is a rating scale for severity of lower urinary tract symptoms (LUTS). The IPSS has a 7-component questionnaire. Each question is scored on a scale from 0 (none/no symptoms) to 5 (frequent symptoms), for a total score range of 0 to 35. Higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline total IPSS, and visit-by-treatment interaction.|Baseline, 4 weeks, 26 weeks|All randomized participants who received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IPSS measurement.||units on a scale||Standard Error|Least Squares Mean
819949|NCT01139762|Primary|Change in Total International Prostate Symptom Score (IPSS) From Baseline to 12 Weeks|The International Prostate Symptom Score (IPSS) is a rating scale for severity of lower urinary tract symptoms (LUTS). The IPSS has a 7-component questionnaire. Each question is scored on a scale from 0 (none/no symptoms) to 5 (frequent symptoms), for a total score range of 0 to 35. Higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline total IPSS, and visit-by-treatment interaction.|Baseline, 12 weeks|All randomized participants who received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IPSS measurement.||units on a scale||Standard Error|Least Squares Mean
819950|NCT01139814|Primary|Evaluation of Major Complications|Safety Evaluation of Major Complications definitely or probably related to Amigo-Controlled Mapping through Visit 3 follow-up.|Seven Days (visit 3), except for any subject with an ongoing SAE that is related to the study will be scheduled for additional evaluations at 14 day intervals.|||Participants||95% Confidence Interval|Number
819951|NCT01139814|Primary|Navigation Performance|Effectiveness Navigation Performance -- The ability to navigate the mapping catheter under Amigo control to at least 80% of 8 pre-specified anatomical locations over all subjects.|During Procedure|||Successful locations|Participants|95% Confidence Interval|Number
819960|NCT01140048|Secondary|Percentage of Participants With Atopic Disorders at 6 Years of Age: Overall and by Prognostic Factor|"Atopic disorders include allergic rhinitis (AR) and/or atopic dermatitis (AD). Atopic disorders was defined as a positive response to the Epidemiology Questionnaire item In the past 6/12 months, has your child had a problem with sneezing or runny or blocked nose when he/she did not have a cold or the flu? for AR and/or a positive response to both of the following items for AD: Has your child had an itchy rash which was coming and going at any time in the past 6/12 months? and Has this itchy rash at any time affected any of the following places: the folds of the elbows, behind the knees, in front of the ankles, under the buttocks, or around the neck, ears, or eyes? for the period of 12 months prior to age 6 years.
Prognostic factors for atopic disorders at age 6 years were derived from baseline characteristic, disease characteristic and family history data, and were identified by a forward stepwise regression model."|At 6 years of age|All Enrolled Participants for whom data for the respective Epidemiology Questionnaire item at age 6 years and prognostic factors were available.||percentage of participants|||Number
819961|NCT01140048|Primary|Percentage of Participants With Asthma at 6 Years of Age: Overall and by Prognostic Factor|"Asthma was defined as a positive response to the Epidemiology Questionnaire item Has your child had wheezing or whistling in the chest in the past 6/12 months? for the period of 12 months prior to age 6 years.
Prognostic factors for asthma at age 6 years were derived from baseline characteristic, disease characteristic and family history data, and were identified by a forward stepwise regression model."|At 6 years of age|All Enrolled Participants for whom data for the respective Epidemiology Questionnaire item at age 6 years and prognostic factors were available.||percentage of participants|||Number
819962|NCT01140061|Primary|Number of Participants Who Discontinued Study Medication Due to an Adverse Event|An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|Up to Day 28|The population consisted of all enrolled participants who received at least one dose of study medication.||Participants|||Number
819963|NCT01140061|Primary|Number of Participants With an Adverse Event|An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|Up to 14 days after last dose of study drug (up to Day 42)|The population consisted of all enrolled participants who received at least one dose of study medication for whom safety data were available.||Participants|||Number
819964|NCT01140061|Primary|Mean Maximum Plasma Concentration (Cmax) of MK-0873 Following Topical Administration for 10 Days|Participant blood samples were collected on Day 11 to determine the Cmax of MK-0873 following topical administration in healthy participants and participants with psoriasis|Day 11|The population consisted of all enrolled participants who received MK-0873 and for whom blood samples were collected and evaluable to determine Cmax.||nM||Standard Deviation|Mean
819965|NCT01140061|Primary|Number of Participants With an Adverse Event of Erythema in Part I of the Study|Following topical administration of MK-0873 or matching placebo patches once daily for 21 days, the number of participants with an adverse event of erythema was recorded. An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|Up to Day 22 in Part 1|The population consisted of all enrolled participants who received at least one dose of study medication in Part I of the study.||Participants|||Number
819966|NCT01140191|Secondary|Complete Cure of Index Lesion by Day 100|Number of participants with complete cure of index lesion by day 100. Cure rate is defined as 100% re-epithelialization of an ulcerated lesion|100 days|Analysis per protocol||Participants|||Count of Participants
819967|NCT01140191|Secondary|Cures of All Other Lesions|Number of participants with 100% re-epithelialization of all ulcerated lesions and resolution of all other types of lesions|100 days|Analysis per protocol||Participants|||Count of Participants
819968|NCT01140191|Primary|Number of Participants With No Relapse of Index Lesion Between Nominal Day 60 and 100|Number of participants with no relapses of lesion between 60 and 100 days. Relapse is defined as a 10% or greater increase in the area of ulceration of the index lesion or a shift from 100% re-epithelialization to < 100% re-epithelialization of the index lesion at Day 100 for those subjects that had 100% re-epithelialization of the index lesion at nominal Day 60 or before|60-100 days|Analysis per protocol||Participants|||Count of Participants
819969|NCT01140191|Primary|Number of Participants Demonstrating Initial Clinical Improvements|Number of participants with > 50% re-epithelialization of index lesion by Day 60 followed by complete re-epithelialization of index lesion on or before nominal Day 100;|60-100 days|Analysis per protocol||Participants|||Count of Participants
819970|NCT01140191|Primary|100% Re-epithelialization of Index Lesion by Nominal Day 60|Number of participants with 100% re-epithelialization of index lesion by nominal Day 60|Day 60|Analysis per protocol||Participants|||Count of Participants
819971|NCT01140191|Primary|Number of Adverse Events|Application site reactions including elicited question about pain, and clinician examination for erythema/redness and swelling/edema Blood chemistries and hematology Vital signs|3 months|Analysis was per protocol||Adverse Events|||Number
819998|NCT01140815|Secondary|6-week Functional Testing|A timed Functional Assessment Test, gait analysis, and balance testing for lower extremity motor function will be performed. Fewer seconds in the result indicates faster performance, which is a positive result.|6 weeks|Patients who were not revised and were able to make an appointment and complete the testing did so.||seconds||Standard Deviation|Mean
820032|NCT01134549|Secondary|Half-life Associated With the Terminal (Log-linear) Elimination Phase (HLλz) for Etelcalcetide||Blood samples for PK assessment were drawn pre-dose, at 5, 10, 15, 20, and 30 minutes, post-dose, and at 1, 1.5, 2, 2.5, 3, 4, 6, 12, 24, 36, and 48 hours after drug administration.|Participants who received etelcalcetide||hours||Standard Deviation|Mean
819972|NCT01140295|Secondary|Proportion of Patients With Abnormal Electrolyte Levels|"The outcome measure was comparison of the proportions of patients who had abnormal electrolyte levels between two groups of patients, Miralax and senna.
Sodium, potassium, chloride, and carbon dioxide levels were measured in mmol/L while urea nitrogen, creatinine, glucose, calcium, magnesium, and phosphorus were measured in mg/dL. Each of these values has a reference range which varies with patients' age and sex. Minimal change of one point above or below normal reference range was dismissed as clinically insignificant. Abnormal creatinine levels were rechecked through glomerular filtration rate calculation to determine if there was any compromise in renal function since abnormal creatinine level does not mean there is renal dysfunction nor that the level is clinically significant."|The outcome measure will be assessed once one day after the completion of colonoscopy preparation|||Proportion of patients|||Number
819973|NCT01140295|Primary|Efficacy of Colon Preparation|Percentage of patients with excellent or good colonoscopy preparation. The efficacy of preparation is measured by using a validated colon cleanliness scale which has 5 different levels (Aronchik scale). Levels 1 and 2, which encompass excellent and good colonoscopy preparation, are routinely recognized as adequate preparation allowing for successful completion of colonoscopy. Levels 3-5 describe incomplete or poor preparation. These levels are associated with significant residual stool encountered at the time of colonoscopy.|The outcome measure will be assessed once one day after the completion of colonoscopy preparation|||percentage of patients|||Number
819974|NCT01140347|Secondary|Number of Participants With Treatment Emergent Positive Anti-Ramucirumab Response [Serum Anti-Ramucirumab Antibody Assessment (Immunogenicity)]|Participants were considered positive for anti-ramucirumab antibodies [anti-drug antibodies (ADA)] if the post-treatment sample had an increase of at least 4-fold in titer from the pretreatment values. If the pretreatment value was not detected or was not present, a 1:20 post-treatment titer was required to indicate treatment emergence of ADA.|Prior to treatment and 1 hour post end of infusion for Cycles 1, 4 and 7 (14-day cycles)|Participants who received at least 1 dose of study drug and had post-treatment ADA analysis.||participants|||Number
819975|NCT01140347|Secondary|Cmax of Ramucirumab, Cycle 7||1 hour following completion of Cycle 7 (14-day cycles) infusion|Participants who received Cycle 7 of Ram and had Cmax results.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
819976|NCT01140347|Secondary|Cmax of Ramucirumab, Cycle 4||1 hour following completion of Cycle 4 (14-day cycles) infusion|Participants who received Cycle 4 of Ram and had Cmax results.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
819977|NCT01140347|Secondary|Maximum Concentration (Cmax) of Ramucirumab, Cycle 1||1 hour following the completion of Cycle 1 (14-day cycle) infusion|Participants who received Cycle 1 of Ram and had Cmax results.||micrograms/milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
819978|NCT01140347|Secondary|Number of Participants With Adverse Events (AEs) and the Number of Participants Who Died|The number of participants with serious AEs (SAEs), other non-serious AEs and participants who died. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.|Baseline to study completion (up to 37 months)|Participants who received at least 1 dose of study drug.||participants|||Number
819979|NCT01140347|Secondary|Change From Baseline in European Quality of Life Questionnaire-5 Dimensions (EQ-5D) Health State Score|The EQ-5D is a self-reported, 5-dimension (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) questionnaire related to the participant's current health state. Each question was scored using a 3 level scale (no problems, some problems, or extreme problems). EQ-5D health state was defined by combining responses from each of the 5 dimensions into a weighted health-state index score according to the United Kingdom (UK) population based algorithm where 0 = death and 1 = perfect health.|Baseline, Prior to infusion on Day 1 of Cycle 4, Cycle 10, and Cycle 16 (14-day cycles), end of treatment (up to 34 months)|Randomized participants who had an EQ-5D score at baseline and the specified time points.||units on a scale||Standard Deviation|Mean
819980|NCT01140347|Secondary|Change From Baseline in the Functional Assessment of Cancer Therapy (FACT) Hepatobiliary Symptom Index-8 (FHSI-8)|The FHSI-8 is a self-administered 8-item questionnaire that measures a participant's symptoms in the domains of jaundice, stomach pain/discomfort weight loss, and fatigue. Participants rated each item on a 5-point scale from 0 (not at all) to 4 (very much). Item scores were calculated as outlined in the FACIT manual. FHSI-8 total score was the sum of each item's score with a total score ranging from 0 (highly symptomatic) to 32 (asymptomatic).|Baseline, Prior to infusion on Day 1 of Cycle 4, Cycle 10, and Cycle 16 (14-day cycles), and end of treatment (up to 34 months)|Randomized participants who had FHSI-8 at baseline and the specified time points.||units on a scale||Standard Deviation|Mean
819981|NCT01140347|Secondary|Time to Radiographic Progression (TTP)|TTP was defined as the time from randomization to the first radiographically documented PD. PD was defined, using RECIST v1.1 criteria, as ≥20% increase in SOD of target lesions, taking as reference smallest sum on study (including baseline sum if it was the smallest). Sum must show an absolute increase of ≥5 mm. Appearance of ≥1 new lesions and unequivocal progression of existing non-target lesions were considered progression. Participants without PD were censored at the day of the last adequate tumor assessment. Progression occurred immediately after ≥2 missed tumor assessments and were censored at the day of the last adequate tumor assessment prior to the missing assessments. Participants who began new anticancer therapy were censored at the day of their last adequate tumor assessment prior to start of new anticancer therapy.|Randomization to PD (up to 36 months)|ITT Population: All randomized participants. Participants censored: Ram=86, Pl=52.||months||95% Confidence Interval|Median
819982|NCT01140347|Secondary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]|ORR was defined, using RECIST v1.1 criteria, as the percentage of participants who achieved a best overall response of CR or PR. CR was defined as the disappearance of all lesions and any intratumor arterial enhancement in target lesions, the normalization of the tumor marker level and all lymph nodes short axis reduced to <10 mm. PR was defined as ≥30% decrease in the SOD of target lesions, including the short axes of any target lymph nodes, taking as reference the baseline SOD of target lesions, no new lesions and stable nontarget lesions. Percentage of participants was calculated as: (number of participants with CR or PR / number of participants randomized) * 100.|Baseline to the date of first evidence of confirmed CR or PR (up to 37 months)|ITT Population: All randomized participants.||percentage of participants||95% Confidence Interval|Number
819983|NCT01140347|Secondary|Progression-Free Survival (PFS)|PFS was defined as time from date of randomization until date of objectively determined progressive disease (PD) as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 or death from any cause. PD was defined as ≥20% increase in sum of diameters (SOD) of target lesions, taking as reference smallest sum on study (including baseline sum if it was smallest). Sum must show a ≥5 millimeter (mm) increase. Appearance of ≥1 new lesions and unequivocal progression of existing non-target lesions were considered progression. In primary analysis, participants alive and without PD were censored at day of last adequate tumor assessment; progression or deaths without progression occurring immediately after ≥2 missed tumor assessments, were censored at day of the last adequate tumor assessment prior to missing assessments; participants who began new anticancer therapy were censored at day of the last adequate tumor assessment prior to start of new anticancer therapy.|Randomization to PD (up to 36 months)|ITT Population: All randomized participants. Participants censored: Ram=43, Pl=19.||months||95% Confidence Interval|Median
819984|NCT01140347|Primary|Overall Survival (OS)|OS was defined as the time from the date of randomization to the date of death from any cause. Participants who were alive at the end of the follow-up period or were lost to follow-up were censored on the last date the participant was known to be alive.|Randomization to death from any cause (up to 37 months)|Intent-to-treat (ITT) Population: All randomized participants. Participants censored: Ramucirumab+BSC (Ram)=65, Placebo+BSC (Pl)=58.||months||95% Confidence Interval|Median
819985|NCT01140360|Primary|Disease Response|To estimate the disease control rate (SD, PR, CR) with Gleevec/Imatinib Mesylate in patients with neurofibromas (NF1). The sum of the longest diameter (LD) for all target lesions will be calculated and reported as the disease measurement. Complete Response (CR) disappearance of target lesions. Partial Response (PR) at least a 30% decrease in the disease measurement, taking as reference the disease measurement done to confirm measurable disease at study entry. Progressive Disease (PD) at least a 20% increase in the disease measurement, taking as reference the smallest disease measurement recorded since the start of treatment. Stable Disease (SD) neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest disease measurement since the treatment started.|1 year|13 participants reached the 1 year evaluation time-point. 6 participants withdrew prior to the 1 year evaluation time-point.||Participants|||Count of Participants
819986|NCT01140477|Secondary|Visual Acuity|Best-Corrected Distance Visual Acuity (BCDVA) without Glare (logMAR)|120 - 180 day postoperative visit|The analysis population only includes those for whom the outcome was measured within the specified time frame.||logMAR||Standard Deviation|Mean
819987|NCT01140477|Secondary|Lens Misalignment|This Outcome Measure was evaluated for Crystalens Toric IOL arm only - Toric IOLs require precise alignment to correct astigmatism; control IOLs do not.|120 - 180 day postoperative visit|The analysis population only includes those for whom the outcome was measured within the specified time frame.||degrees||Standard Deviation|Mean
819988|NCT01140477|Primary|Percent Reduction in Absolute Cylinder|Percent reduction in absolute cylinder expressed as a percentage of the intended reduction in cylinder. Cylinder reduction is the measurement for astigmatism reduction. Astigmatism is a form of refractive error that can affect uncorrected visual acuity (at all distances). Reducing cylinder should improve UCVA, but other elements of refractive error, such as myopia or hyperopia, can also affect UCVA. Best corrected visual acuity (BCVA) is not affected by refractive error.|120 – 180 day postoperative visit|The analysis population only includes those for whom the outcome was measured within the specified time frame.||percentage of intended cylinder reduct||95% Confidence Interval|Mean
819989|NCT01140503|Secondary|The Secondary Outcome Measure Will be Efficacy as Measured by the Mean Change in CDASI-activity at 12 Weeks|The CDASI (Cutaneous Dermatomyositis Activity and Severity Index) is a validated instrument to measure skin disease activity in dermatomyositis. A clinically meaningful change is a decrease of 4 points. All missing data are imputed using last observation carried forward. Calculation is performed as the score at 12 weeks minus the score at baseline.|Data collected at baseline at 12 weeks|||units on a scale||Standard Deviation|Mean
819990|NCT01140503|Secondary|The Secondary Outcome Measure Will be Efficacy, as Measured by the Number of Participants Experiencing a 30% Decreased in the CDASI-a Score at 12 Weeks.|This was an intent to treat analysis--dropouts are considered treatment failures. Missing data at 12 weeks imputed by last observation carried forward.|Data collected at 12 weeks after baseline visit.|||participants|||Number
819991|NCT01140503|Primary|The Primary Endpoint Analysis Will be Safety, as Measured by the Number of Adverse Events and Serious Adverse Events Occuring During 12 Weeks of Therapy and 4 Weeks of Followup.||16 weeks|||adverse events|||Number
819992|NCT01140646|Secondary|Adverse Event Grade Incidence||End of study||||||
819993|NCT01140646|Secondary|Change From Baseline in Self-assessment Items||End of study||||||
819994|NCT01140646|Primary|Percent of Baseline in Average Hot Flash Activity (Score and Frequency)|Hot flash score was defined as the number of mild hot flashes for the week plus two times the number of moderate hot flashes plus three times the number of severe hot flashes plus four times the number of very severe hot flashes. Hot flash frequency was defined as the average number of hot flashes per day for each week. Week 7 percent of baseline was calculated. The reduction in hot flash score and frequency can be calculated by subtracting the week 7 percent of baseline from 100 percent.|From baseline to week 7|Analysis population includes only the subjects who have completed the quality of life self-assessment questionnaire.||Percent of baseline||95% Confidence Interval|Mean
819995|NCT01140815|Secondary|2-year Functional Testing|A timed Functional Assessment Test, gait analysis, and balance testing for lower extremity motor function will be performed. Fewer seconds in the result indicates faster performance, which is a positive result.|2 years|Patients who were not revised and were able to make an appointment and complete the testing did so.||seconds||Standard Deviation|Mean
819996|NCT01140815|Secondary|1-year Functional Testing|A timed Functional Assessment Test, gait analysis, and balance testing for lower extremity motor function will be performed. Fewer seconds in the result indicates faster performance, which is a positive result.|1 year|Patients who were not revised and were able to make an appointment and complete the testing did so.||seconds||Standard Deviation|Mean
819997|NCT01140815|Secondary|4-month Functional Testing|A timed Functional Assessment Test, gait analysis, and balance testing for lower extremity motor function will be performed. Fewer seconds in the result indicates faster performance, which is a positive result.|4 months|Patients who were not revised and were able to make an appointment and complete the testing did so.||seconds||Standard Deviation|Mean
819999|NCT01140815|Secondary|2-year Patient Surveys|Serial patient evaluation of function will be assessed using the Oxford Knee Outcome Questionnaire. The Oxford Questionnaire consists of 12 questions, each with a value of 0 (bad) to 4(good). The results are summed for a total score of 0(bad) to 48(good).|2 years|Patients who were not revised within 2 years and were able to complete a questionnaire did so.||units on a scale 0-48||Full Range|Mean
820000|NCT01140815|Secondary|2-year X-rays|Knee Society Roentgenographic Evaluation and Scoring System will assess alignment; any evidence of loosening as indicated primarily by radiolucencies > 2mm; evidence of surface wear or particulate debris generation as indicated by early osteolysis, implant migration, or other clinical or radiographic abnormalities. Number of participants with these radiographic abnormalities by X-ray at 2 years are reported.|2 years|||participants|||Number
820001|NCT01140815|Secondary|1-year X-rays|Knee Society Roentgenographic Evaluation and Scoring System will assess alignment; any evidence of loosening as indicated primarily by radiolucencies > 2mm; evidence of surface wear or particulate debris generation as indicated by early osteolysis, implant migration, or other clinical or radiographic abnormalities. Number of participants with these radiographic abnormalities by X-ray at 1 year are reported.|1 year|||participants|||Number
820002|NCT01140815|Secondary|4-month X-rays|Knee Society Roentgenographic Evaluation and Scoring System will assess alignment; any evidence of loosening as indicated primarily by radiolucencies > 2mm; evidence of surface wear or particulate debris generation as indicated by early osteolysis, implant migration, or other clinical or radiographic abnormalities. Number of participants with these radiographic abnormalities by X-ray at 4 months are reported.|4 months|||participants|||Number
820003|NCT01140815|Secondary|6-Week X-rays|Knee Society Roentgenographic Evaluation and Scoring System will assess alignment; any evidence of loosening as indicated primarily by radiolucencies > 2mm; evidence of surface wear or particulate debris generation as indicated by early osteolysis, implant migration, or other clinical or radiographic abnormalities. Number of participants with these radiographic abnormalities by X-ray at 6 weeks are reported.|6 weeks|||participants|||Number
820004|NCT01140815|Primary|1-year Knee Society Score|Knee Society Clinical Rating System (KSS) provides for separate knee pain and patient functional assessment scores. Scale of 0-100 with higher values representing a better score.|1 year|||units on a scale 0-100||Standard Deviation|Mean
820005|NCT01140815|Primary|4-Month Knee Society Score|Knee Society Clinical Rating System (KSS) provides for separate knee pain and patient functional assessment scores. Scale of 0-100 with higher values representing a better score.|4 months|||units on a scale 0-100||Standard Deviation|Mean
820006|NCT01140815|Primary|6-Week Knee Society Score|Knee Society Clinical Rating System (KSS) provides for separate knee pain and patient functional assessment scores. Scale of 0-100 with higher values representing a better score.|6 weeks|||units on a scale 0-100||Standard Deviation|Mean
820007|NCT01140815|Primary|2-Year Knee Society Score|Knee Society Clinical Rating System (KSS) provides for separate knee pain and patient functional assessment scores. Scale of 0-100 with higher values representing a better score.|2 years|||units on a scale 0-100||Standard Deviation|Mean
820008|NCT01140867|Secondary|QoL-QOLIE31 (Quality of Life in Epilepsy)|Quality of life assessment tool. Overall scores is calculated by summing subsections, and it ranges from 0 to 100. Higher score presents higher quality of life.|Baseline and 16 weeks|Efficacy analyses were based on the FAS (Full analysis set) population, which was comprised of all patients who administrated Zonisamide at least once and reached the maintenance period to evaluate the primary endpoint. Regarding QOLIE-31, among FAS population, the patients who have both of baseline and 16 week evaluation are included.||Units on a Scale||Standard Deviation|Mean
820009|NCT01140867|Secondary|Responder Rate|The percentage of participants whose median percentage change in seizure frequency after Zonisamide treatment is reduced over 50%.|Baseline and 16 weeks|Efficacy analyses were based on the FAS (Full analysis set) population, which was comprised of all patients who administrated Zonisamide at least once and reached the maintenance period to evaluate the primary endpoint.||Percentage of Participants|||Number
820010|NCT01140867|Secondary|Seizure Free Rate|The percentage of the participants who experienced no seizure during the trial.|16 weeks|Efficacy analyses were based on the FAS (Full analysis set) population, which was comprised of all patients who administrated Zonisamide at least once and reached the maintenance period to evaluate the primary endpoint.||Percentage of Participants|||Number
820011|NCT01140867|Primary|Seizure Reduction Rate|The percentage of the seizure reduction after Zonisamide treatment comparing baseline seizure frequency.|Baseline and 16 weeks|Efficacy analyses were based on the FAS (Full analysis set) population, which was comprised of all patients who administrated Zonisamide at least once and reached the maintenance period to evaluate the primary endpoint.||Percentage of Seizure Reduction Rate||Standard Deviation|Mean
820012|NCT01140880|Primary|Course Completion|PEP course completion is a dichotomous variable (0 = Not completed; 1 = Completed) that indicates whether the participant maintained sufficient adherence to the Truvada regimen to receive all 28 doses of the medication. Note: Missing 3 Truvada doses in a row terminated the PEP-intervention and prevented Course Completion.|28-days post initiation|40 participants initiated PEP during the study, of which 30 had evaluable course completion data.||participants|||Number
820013|NCT01140880|Primary|Medication Adherence|Adherence to Truvada medication (if initiated) as assessed by self-report and pill count.|Daily throughout medication course|40 participants initiated Truvada, of which 30 had evaluable medication adherence and course completion data (the 10 others were involved in the protocol violation).||proportion|||Number
820014|NCT01140880|Secondary|Abstinence From Stimulant Drug Use (Cocaine, Amphetamine, Methamphetamine)|Abstinence will be measured using thrice weekly urine drug screens and self-report|Thrice-weekly for 8 weeks|170 participants enrolled in the study, of which 30 were involved in a protocol violation that rendered their data un-analyzable. The final analytical sample is N = 140.||Stimulant-free urinalyses||Standard Deviation|Mean
820015|NCT01140880|Primary|Time From Exposure to Truvada Initiation|Time to initiation is defined as the number of hours between exposure to viral inoculum and initiation of the Truvada medication regimen.|6-month follow-up|40 participants with evaluable data initiated Truvada during the course of the study.||hours||Standard Deviation|Mean
820031|NCT01134549|Secondary|Total Body Clearance (CL) for Etelcalcetide||Blood samples for PK assessment were drawn pre-dose, at 5, 10, 15, 20, and 30 minutes, post-dose, and at 1, 1.5, 2, 2.5, 3, 4, 6, 12, 24, 36, and 48 hours after drug administration.|Participants who received etelcalcetide||L/hr||Standard Deviation|Mean
820016|NCT01140906|Secondary|Potential Discontinuation Symptoms After Abrupt Discontinuation of Treatment With Vortioxetine|The Discontinuation-Emergent Signs and Symptoms Scale (DESS) was designed to evaluate possible effects of discontinuation of antidepressant therapy. It is a clinician-rated instrument that queries for signs and symptoms on a 43-item checklist (for example, agitation, insomnia, fatigue, and dizziness) to assess whether the item (event) is discontinuation-emergent. A new or worsened event reported after discontinuation of therapy scores 1 point on the checklist, and the DESS total score is the sum of all positive scores on the checklist. A higher score indicates more symptoms.|Change from Week 8 in DESS total score analyzed at Week 10|All Patients Completed Set (APCS), OC, Analysis of Covariance (ANCOVA)||units on a scale||Standard Error|Mean
820017|NCT01140906|Secondary|Change From Baseline in ASEX Total Score After 8 Weeks of Treatment|The Arizona Sexual Experience Scale (ASEX) is a 5-item, patient self-rated scale that evaluates a patient’s recent sexual experience. Patients are asked to assess their own experience over the last week (for example, “How strong is your sex drive?”, “Are your orgasms satisfying?”) and respond on a 6-point scale for each item. The ASEX is used to identify individuals with sexual dysfunction. Possible total score ranges from 5 to 30, with the higher score indicating more patient sexual dysfunction. A negative change indicates a lower sexual dysfunction.|Baseline and Week 8|FAS, MMRM||units on a scale||Standard Error|Mean
820018|NCT01140906|Secondary|Change From Baseline in SDS Total Score After 8 Weeks of Treatment|The Sheehan Disability Scale (SDS) comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). The higher the score, the more severe.|Baseline and Week 8|FAS, MMRM||units on a scale||Standard Error|Mean
820019|NCT01140906|Secondary|Proportion of Remitters at Week 8 (Remission Defined as a MADRS Total Score <=10)||Week 8|FAS, LOCF, Logistic Regression||percentage of patients|||Number
820020|NCT01140906|Secondary|Change From Baseline in MADRS Total Score After 8 Weeks of Treatment in Patients With Baseline HAM-A Total Score ≥20||Baseline and Week 8|FAS, MMRM||units on a scale||Standard Error|Mean
820021|NCT01140906|Secondary|Change in Clinical Status Using CGI-I Score at Week 8|The Clinical Global Impression - Global Improvement (CGI-I) is a 7-point scale rated from 1 (very much improved) to 7 (very much worse). The investigator rated the patient's overall improvement relative to baseline, whether or not, in the opinion of the investigator, this was entirely due to the drug treatment.|Week 8|FAS, MMRM||units on a scale||Standard Error|Mean
820022|NCT01140906|Secondary|Proportion of Responders at Week 8 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline)||Week 8|FAS, last observation carried forward (LOCF), Logistic Regression||percentage of patients|||Number
820023|NCT01140906|Primary|Change From Baseline in MADRS Total Score After 8 Weeks of Treatment.|The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe.|Baseline and Week 8|Full-analysis set (FAS), mixed model for repeated measurements (MMRM)||units on a scale||Standard Error|Mean
820024|NCT01141205|Secondary|Increase in Blood CD4 T-cell Counts|Analyzed: Participants (minus drop-outs and withdrawn) with measured blood CD4 T-cell counts (cells/microliter). Reported: Numbers of participants obtaining an increase in measured blood CD4 T-cell counts post vaccination of >100 CD4 Tcell per microliter|up to 6 months post vaccination|Participants minus drop-outs and withdrawn participants||participants with increased CD4 count|||Number
820025|NCT01141205|Secondary|Lowering of HIV-1 RNA Viral-load in HIV-1 Immune Responders More Than 1 Log|changes (lowering) in Plasma HIV-1 RNA viral-load (measured by Quantitative RT-PCR kit, ROCHE) of more than 1 log|up to 6 months post immunization|Participants minus drop outs and participants withdrawn by them selves or by the physicians||participants with lowering of VL|||Number
820026|NCT01141205|Secondary|Induction of New T-cell Immune Response by the Vaccine|induction of new T-cell immune response against one or more of the vaccine epitopes using Interferon gamma Enzyme Linked Immuno spot assay (IFNg-ELISPOT assay)measuring Spot forming Unis per 1 million periferal blood mononuclear cells (SFU/1 mio PBMCs) above treshold (> 50 sfu/mio PBMC).|up to 6 months after last immunisation|Analyzed: Participants minus drop-outs and withdrawn participants. Reported: numbers of participants with a new induced ELISPOT Y-cell immune response to the vaccine peptide epitopes||ELISPOT responders|||Number
820027|NCT01141205|Primary|Tolerability and Safety of the Treatment.|"We report here the numbers of participants with vaccine related adverse events degree 3 or 4.
Our goal for safety and tolerability was: Fewer than or 3 patients of the 15 vaccine treated show treatment related (reaction 3) side-effects of degree 3 or 4."|up to 6 months after end of treatment|Analyzed: number of participants started minus individuals lost to follow up or participants that withdraw. Thus we include the two individuals where the physician stopped his/her participation because of SAE not related to the vaccine or to the placebo. Reported: numbers of participants with vaccina related SAE||participants|||Number
820028|NCT01141283|Primary|The Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Safety was assessed using reports of adverse events, clinical laboratory results, findings from physical examinations, and vital sign measurements.|6 months.|The extension safety population consisted of all subjects who were exposed to BTDS and had at least 1 safety assessment during extension phase.||participants|||Number
820029|NCT01134549|Secondary|Number of Participants With Antibodies to Etelcalcetide|Serum samples were analyzed for antibodies against etelcalcetide using a validated enzyme-linked immunosorbent assay (ELISA).|Samples for antibody analysis were collected pre-dose and between days 7-12 and days 21-28.|Participants who received etelcalcetide||Participants|||Count of Participants
820030|NCT01134549|Secondary|Volume of Distribution at Steady State for Etelcalcetide||Blood samples for PK assessment were drawn pre-dose, at 5, 10, 15, 20, and 30 minutes, post-dose, and at 1, 1.5, 2, 2.5, 3, 4, 6, 12, 24, 36, and 48 hours after drug administration.|Participants who received etelcalcetide||liters||Standard Deviation|Mean
820033|NCT01134549|Secondary|Terminal Elimination Rate Constant (λz) for Etelcalcetide||Blood samples for PK assessment were drawn pre-dose, at 5, 10, 15, 20, and 30 minutes, post-dose, and at 1, 1.5, 2, 2.5, 3, 4, 6, 12, 24, 36, and 48 hours after drug administration.|Participants who received etelcalcetide||1/hr||Standard Deviation|Mean
820034|NCT01134549|Secondary|Percent Observed Area Under the Concentration-time Curve Extrapolated to Infinity Resulting From Extrapolation to Concentration of 0 ng/mL (AUC%Extrapobs)||Blood samples for PK assessment were drawn pre-dose, at 5, 10, 15, 20, and 30 minutes, post-dose, and at 1, 1.5, 2, 2.5, 3, 4, 6, 12, 24, 36, and 48 hours after drug administration.|Participants who received etelcalcetide||percentage of AUCINFobs||Standard Deviation|Mean
820035|NCT01134549|Secondary|Observed Area Under the Concentration-time Curve Extrapolated to Infinity (AUCINFobs) for Etelcalcetide||Blood samples for PK assessment were drawn pre-dose, at 5, 10, 15, 20, and 30 minutes, post-dose, and at 1, 1.5, 2, 2.5, 3, 4, 6, 12, 24, 36, and 48 hours after drug administration.|Participants who received etelcalcetide||hr*μg/L||Standard Deviation|Mean
820036|NCT01134549|Secondary|Area Under the Concentration-time Curve Between the Time of Dose and the Last Time Point (AUCall) for Etelcalcetide||Blood samples for PK assessment were drawn pre-dose, at 5, 10, 15, 20, and 30 minutes, post-dose, and at 1, 1.5, 2, 2.5, 3, 4, 6, 12, 24, 36, and 48 hours after drug administration.|Participants who received etelcalcetide||hr*μg/L||Standard Deviation|Mean
820037|NCT01134549|Secondary|Maximum Observed Concentration (Cmax) for Etelcalcetide|Plasma samples were analyzed for levels of etelcalcetide for pharmacokinetic (PK) analysis using a validated liquid chromatography/mass spectrometry (LC/MS) method.|Blood samples for PK assessment were drawn pre-dose, at 5, 10, 15, 20, and 30 minutes, post-dose, and at 1, 1.5, 2, 2.5, 3, 4, 6, 12, 24, 36, and 48 hours after drug administration.|Participants who received etelcalcetide||μg/L||Standard Deviation|Mean
820038|NCT01134549|Secondary|Percent Change From Baseline in Serum 1,25 (OH)2 Vitamin D||Baseline and 12, 24, and 48 hours post-dose|Modified intent-to-treat population||percent change||Standard Deviation|Mean
820039|NCT01134549|Secondary|Percent Change From Baseline in Serum Calcitonin||Baseline and 10 minutes, 30 minutes, 3, 12, 24, and 48 hours post-dose|Modified intent-to-treat population||percent change||Standard Deviation|Mean
820040|NCT01134549|Secondary|Change From Baseline in Serum Phosphate||Baseline and 10 minutes, 30 minutes, 1 hour, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42 and 48 hours post-dose|Modified intent-to-treat population with available data at each time point||mmol/L||Standard Deviation|Mean
820041|NCT01134549|Secondary|Change From Baseline in Serum Corrected Calcium||Baseline and 10 minutes, 30 minutes, 1 hour, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42 and 48 hours post-dose|Modified intent-to-treat population with available data at each time point||mmol/L||Standard Deviation|Mean
820042|NCT01134549|Secondary|Change From Baseline in Serum Total Calcium||Baseline and 10 minutes, 30 minutes, 1 hour, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42 and 48 hours post-dose|Modified intent-to-treat population with available data at each time point||mmol/L||Standard Deviation|Mean
820043|NCT01134549|Secondary|Percent Change From Baseline in Plasma Ionized Calcium||Baseline and 10 minutes, 30 minutes, 1 hour, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42 and 48 hours post-dose|Modified intent-to-treat population||percent change||Standard Deviation|Mean
820044|NCT01134549|Secondary|Percent Change From Baseline in Serum Parathyroid Hormone||Baseline and 10 minutes, 30 minutes, 1 hour, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42 and 48 hours post-dose|Modified intent-to-treat population||percent change||Standard Deviation|Mean
820045|NCT01134549|Primary|Number of Participants With Adverse Events||From the first dose of study drug through 7 days.|The modified intent-to-treat (MITT) population consisted of all participants who were randomized and received study medication.||participants|||Number
820046|NCT01134614|Secondary|Proportion of Patients With Objective Response|Objective response was evaluated using RECIST (Response Evaluation Criteria in Solid Tumors) 1.1 criteria. Per RECIST criteria, complete response (CR) = disappearance of all target and non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 mm short axis). Partial response (PR)= At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. To be assigned a status of partial response, changes in tumor measurements must be confirmed by a repeat assessment performed no less than four weeks after the criteria for response is met. Objective response = CR + PR.|Assessed every 3 months for 2 years, then every 6 months for 3 years|All randomized patients are included in this analysis.||Proportion of patients||95% Confidence Interval|Number
820047|NCT01134614|Secondary|Progression-free Survival (PFS)|Progression-free survival is defined as the time from randomization to disease progression or death, whichever occurs first. Response and disease progression will be evaluated using the international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Disease progression is defined as >= 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) and the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions is also considered progression.|Assessed every 3 months for 2 years, then every 6 months for 3 years|All randomized patients are included in this analysis.||Months||95% Confidence Interval|Median
820048|NCT01134614|Primary|Overall Survival|Overall survival is defined as the time from randomization to death from any cause.|Assessed every 3 months for 2 years, then every 6 months for 3 years|All randomized patients are included in this analysis.||Months||95% Confidence Interval|Median
820049|NCT01134627|Other Pre-specified|Relapse Severity Based on Expanded Disability Status Scale (EDSS)|EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. EDSS progression was defined as increase by at least 1 point if last value of EDSS was equal to 5.5 and by at least 0.5 points if last EDSS was more than 5.5.|96 weeks (+/- 1 week) or ET|"ITT population included all the participants who were randomized to study medication. Number of participants analyzed N included those participants who were evaluated for this particular measure."||Units on a scale||Standard Deviation|Mean
820085|NCT01134939|Secondary|Changes in the CD4+ Cell Count After 36 Months From Baseline|The change in the Cluster of differentiation 4 (CD4+) cell count from baseline after 36 months was calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase in CD4+ cell count.|Baseline and 36 months|Patients from FAS with values for CD4+ at baseline and after 36 months.||cells/mm^3||Standard Deviation|Mean
820050|NCT01134627|Other Pre-specified|Number of Participants With Total Number of Reported Relapses (Documented and Undocumented Relapses)|Documented relapses (relapse: development of new/exacerbation of existing neurological symptoms, persisting for >48 hrs and with previous period for >30 days with stable/improving condition; relapse documented by exacerbation >=1 point increase in 2 functional systems/2 points increase in 1 functional system, or >=0.5 point increase on EDSS which assesses disability in 8 functional systems with overall score ranging from 0 [normal] to 10 [death due to MS]) and undocumented relapses only fulfilled condition for relapse.|Baseline up to 96 weeks (+/- 1 week) or ET|ITT population included all the participants who were randomized and received study medication.||participants|||Number
820051|NCT01134627|Other Pre-specified|Number of Relapse Free Participants Without Progression|Analysis based on documented relapses (relapse: development of new/exacerbation of existing neurological symptoms, persisting for >48 hrs and with previous period for >30 days with stable/improving condition; relapse documented by exacerbation >=1 point increase in 2 functional systems/2 points increase in 1 functional system, or >=0.5 point increase on EDSS which assesses disability in 8 functional systems with overall score ranging from 0 [normal] to 10 [death due to MS]) and overall relapses (documented and undocumented relapses); undocumented relapses only fulfilled condition for relapse.|Baseline up to 96 weeks (+/- 1 week) or ET|"ITT population included all the participants who were randomized and received study medication. Number of participants analyzed N included those participants who were evaluated for this particular measure."||participants|||Number
820052|NCT01134627|Other Pre-specified|Relapse Count|A relapse was defined as the development of new or the exacerbation of existing neurological symptoms or signs, in the absence of fever, persisting for more than 48 hours and with a previous period for more than 30 days with a stable or an improving condition.|Week 48 (+/- 1 week) or ET|Data was not analyzed due to insufficient number of participants available for the analysis of the measure and the study was prematurely terminated.|||||
820053|NCT01134627|Other Pre-specified|Burden of Disease|The burden of disease (BOD) is the total area of MS lesions (abnormal plaques) in the brain measured on Time Constant 1 (T1) or T2 weighted MRI.|Baseline up to 96 weeks (+/- 1 week) or ET|Sub-group of ITT population included limited number of participants at pre-selected sites selected on basis of availability of MRI scanning facilities and the willingness of the site to participate.||square millimeter (mm^2)||Standard Deviation|Mean
820054|NCT01134627|Other Pre-specified|Percentage of Time Constant 2 (T2) Active Scans Per Participant|Inflammatory disease activity was assessed by MRI measurement of the percentage of T2 active scans.|Baseline up to 96 weeks (+/- 1 week) or ET|Data was not analyzed due to insufficient number of participants available for the analysis of this measure and the study was prematurely terminated.|||||
820055|NCT01134627|Other Pre-specified|Number of Time Constant 2 (T2) Active Lesions|Inflammatory disease activity was assessed by MRI measurement of the number of T2 active lesions.|Week 48 up to Week 96 (+/- 1 week) or ET|Data was not analyzed due to insufficient number of participants available for the analysis of this measure and the study was prematurely terminated.|||||
820056|NCT01134627|Other Pre-specified|Number of Participants With Onset of Disability Progression|Disability progression was defined as an increase, compared to baseline evaluation of >= 1.0 points on EDSS if EDSS was >= 1.0 at baseline or >=1.5 point on EDSS if EDSS was 0.0 at baseline. EDSS assesses disability in 8 functional systems with overall score ranging from 0 (normal) to 10 (death due to MS).|Baseline up to 96 weeks (+/- 1 week) or ET|ITT population included all the participants who were randomized and received study medication.||participants|||Number
820057|NCT01134627|Secondary|Changes in Brain Volume Measured on Magnetic Resonance Imaging (MRI)|Changes in brain volume were measured as the brain parenchymal fraction using MRI scans.|Screening , final visit (96 weeks [+/- 1 week]) or ET|Sub-group of ITT population included limited number of participants at pre-selected sites selected on basis of availability of MRI scanning facilities and the willingness of the site to participate.||cubic millimeter (mm^3)||Standard Deviation|Mean
820058|NCT01134627|Secondary|Number of New or Enlarging Lesions on Time Constant 2 (T2) Weighted Magnetic Resonance Imaging (MRI)|Inflammatory disease activity was assessed by MRI measurement of the number of new or enlarging T2 lesions.|Final visit (96 weeks [+/- 1 week]) or ET|Sub-group of ITT population included limited number of participants at pre-selected sites selected on basis of availability of MRI scanning facilities and the willingness of the site to participate.||lesions||Standard Deviation|Mean
820059|NCT01134627|Secondary|Number of Participants With Documented Relapses|Documented relapse: development of new/exacerbation of existing neurological symptoms, persisting for >48 hrs and with previous period for >30 days with stable/improving condition. Exacerbation was >=1 point increase in 2 functional systems /2 points increase in 1 system, either in pyramidal, cerebral, brain-stem, sensory, bowel and bladder, visual, cerebral or other functional system or >=0.5 point increase on EDSS which assesses disability in 8 functional systems with overall score ranging from 0 (normal) to 10 (death due to MS).|Baseline up to 96 weeks (+/- 1 week) or ET|ITT population included all the participants who were randomized and received study medication.||participants|||Number
820060|NCT01134627|Primary|Number of Participants Who Experienced First Documented Relapse|Documented relapse: development of new/exacerbation of existing neurological symptoms, persisting for >48 hrs and with previous period for >30 days with stable/improving condition. Exacerbation = at least (>=)1 point increase in 2 functional systems/2 points increase in 1 system,either in pyramidal, cerebral, brain-stem, sensory, bowel and bladder, visual, cerebral or other functional system or >=0.5 point increase on expanded disability status scale (EDSS) which assesses disability in 8 functional systems with overall score ranging from 0 (normal) to 10 (death due to multiple sclerosis [MS]).|Baseline up to 96 weeks (+/- 1 week) or early termination (ET)|The Intention to Treat (ITT) population included all the participants who were randomized and received study medication.||participants|||Number
820061|NCT01134705|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)|The adult RQLQ has 28 questions in 7 domains (activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional). Participants were asked to recall their experiences during the previous week and to give their responses on a 7-point scale (0 = Least severe to 6 = Extremely severe). The overall RQLQ score is the mean of all 28 responses, and ranges from 0 to 7. A negative change from Baseline score indicates improvement.|Baseline and Week 6|The RQLQ population included adults (18 years and older) with an impaired quality of life at Baseline as defined by a RQLQ score at the Randomization Visit of 3.0 or greater.||units on a scale||Standard Error|Least Squares Mean
820062|NCT01134705|Secondary|Change From Baseline in Average AM and PM Instantaneous Total Nasal Symptom Score (iTNSS) Over the Six-week Treatment Period|"Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) over the 10 minutes prior to assessment twice daily (AM & PM) using the following scale:
0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (awareness of symptoms, bothersome but tolerable); 3=severe (symptoms hard to tolerate, interfere with daily activities and/or sleeping).
The total nasal symptom score (sum of the 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from Baseline score indicates symptom improvement."|Baseline (Days -3 to 0) and Days 1-43 (6-week Treatment Period)|Intent to treat population.||units on a scale||Standard Error|Least Squares Mean
820063|NCT01134705|Primary|Change From Baseline in Average AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Six-week Treatment Period|"Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) over the past 12 hours twice daily (AM & PM) using the following scale:
0=absent (no sign/symptom); 1=mild (sign/symptom present, awareness, easily tolerated); 2=moderate (awareness of sign/symptom, bothersome but tolerable); 3=severe (sign/symptoms hard to tolerate, interfere with daily activities and/or sleeping).
The total nasal symptom score (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from Baseline score indicates symptom improvement."|Baseline (Days -3 to 0) and Days 1-43 (6-week Treatment Period)|Intent-to-Treat (ITT) Population: The ITT population included all randomized patients who received at least one dose of randomized study medication and had at least one post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
820064|NCT01134731|Secondary|Mean Score of Montgomery-Asberg Depression Scale of Three Treatment Groups (Paliperidone, Lithium and Placebo) After 3 Months of Treatment|The Montgomery-Asberg Depression Rating Scale will be used to measure depressive symptoms to determine the efficacy of the study drugs. It has 10 items (subscales) ranging from 0-6. Therefore the total score ranges from 0-60, with lower scores indicating better outcomes. The subscales were summed for a total score.|baseline to 12 weeks|||units on a scale||Standard Deviation|Mean
820065|NCT01134731|Primary|Mean Score of Beck Scale for Suicidal Ideation of Three Treatment Groups (Paliperidone, Lithium and Placebo) After 3 Months of Treatment|The Beck Scale for Suicidal Ideation will be used to measure the efficacy of the study drugs. The primary outcome measure is the Beck Suicide Scale Self Report. The primary outcome measure is the Beck Suicide Scale Self Report. It has 21 questions (subscales) with values ranging from 0-2. Therefore the total score ranges from 0-42, with lower scores indicating better outcomes. The subscales were summed to achieve a total score.|baseline to 12 weeks|||units on a scale||Standard Deviation|Mean
820066|NCT01134783|Secondary|Change in Weight From Baseline to 12 Months|Comparison of the effects of the intervention and control groups with regard to change in weight from baseline to 12 months|Baseline to 12 Months|The original study design was 4 arms (1 control & 3 intervention) that varied in the way the 4-month curriculum was delivered. Our formative work showed that students not being able to choose the course delivery method would limit interest in study participation. We changed the study design to 2 arms, which was approved by the EARLY trials DSMB.||Kg||Standard Error|Mean
820067|NCT01134783|Secondary|Change in BMI From Baseline to 12 Months|Comparison of the effects of the intervention and control groups with regard to change in BMI from baseline to 12 months|Baseline to 12 Months|The original study design was 4 arms (1 control & 3 intervention) that varied in the way the 4-month curriculum was delivered. Our formative work showed that students not being able to choose the course delivery method would limit interest in study participation. We changed the study design to 2 arms, which was approved by the EARLY trials DSMB.||kg/m2||Standard Error|Mean
820068|NCT01134783|Secondary|Change in Weight From Baseline to 4 Months|Comparison of the effects of the intervention and control groups with regard to change in weight from baseline to 4 months|Baseline to 4 Months|The original study design was 4 arms (1 control & 3 intervention) that varied in the way the 4-month curriculum was delivered. Our formative work showed that students not being able to choose the course delivery method would limit interest in study participation. We changed the study design to 2 arms, which was approved by the EARLY trials DSMB.||Kg||Standard Error|Mean
820069|NCT01134783|Secondary|Change in BMI From Baseline to 4 Months|Comparison of the effects of the intervention and control groups with regard to change in BMI from baseline to 4 months|Baseline to 4 Months|The original study design was 4 arms (1 control & 3 intervention) that varied in the way the 4-month curriculum was delivered. Our formative work showed that students not being able to choose the course delivery method would limit interest in study participation. We changed the study design to 2 arms, which was approved by the EARLY trials DSMB.||kg/m2||Standard Error|Mean
820070|NCT01134783|Secondary|Prevalence of Overweight/Obese|The prevalence of overweight/obese between intervention and control students|Baseline to 24 Months|The original study design was 4 arms (1 control & 3 intervention) that varied in the way the 4-month curriculum was delivered. Our formative work showed that students not being able to choose the course delivery method would limit interest in study participation. We changed the study design to 2 arms, which was approved by the EARLY trials DSMB.||percentage of participants|||Number
820071|NCT01134783|Primary|Change in Body Mass Index (BMI)|The primary aim of this study is to examine the effectiveness of a 24-month weight gain prevention intervention to positively affect body mass index (BMI) in 2-year college students. Our hypothesis is that students randomized to an intervention condition will experience a smaller increase in mean BMI post treatment as compared to students randomized to the control condition.|Baseline to 24 Months|The original study design was 4 arms (1 control & 3 intervention) that varied in the way the 4-month curriculum was delivered. Our formative work showed that students not being able to choose the course delivery method would limit interest in study participation. We changed the study design to 2 arms, which was approved by the EARLY trials DSMB.||kg/m2||Standard Error|Mean
820086|NCT01134939|Secondary|Changes in the Viral Load After 36 Months From Baseline|The change in the log10 viral load from baseline after 36 months was calculated by subtracting the baseline value from the value after 36 months. Therefore, a negative change represents a decrease in viral load.|Baseline and 36 months|Patients from FAS with values for viral load at baseline and after 36 months.||Log10 copies/mL||Standard Deviation|Mean
820244|NCT01142193|Primary|Percent Reduction From Baseline in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Plus Maintenance Phase Compared to Baseline.||11 weeks|Intent-to-treat (ITT): all subjects who were randomized and received at least 1 dose of study drug||Percent Reduction||Full Range|Median
820072|NCT01134887|Primary|Patient Activation Measure|Veteran self-management of hypertension measured via the 13-item, (0-100 point range), Patient Activation Measure (PAM). Administered at baseline (1st visit) and after each additional follow-up visit during the next 12-months (+2 max). Rasch conversion changed raw scores to the PAM interval measure. Reported outcome is difference in mean PAM scores at baseline and during 12-month follow-up. If a participant had two PAM scores during the follow-up period, the average of the two was taken to calculate a combined follow-up score. Higher PAM scores represent higher levels of self-activation. Research on the PAM measure indicates that each point increase in PAM score correlates to a 2% decrease in hospitalization and a 2% increase in medication adherence. Ranges for Baseline PAM scores: Intervention = 46.1 (min) to 84.3 (max); Control = 43.2 (min) to 77 (max). Ranges for Follow-up PAM scores: Intervention = 48.4 (min) to 100 (max); Control = 45.1 (min) to 80.1 (max).|12 months|Veterans participating in CHOICE study randomized to two arms: intervention or attention control. The 13-item Patient Activation Measure was administered at baseline and up to two additional times during the following 12 months. Rasch conversion of the raw PAM scores was performed to ensure the final scores were linear and interval measures.||units on a scale||Standard Deviation|Mean
820073|NCT01134900|Secondary|Time to Provider Response|Time from study event to modification or discontinuation of targeted medication|Until patient discharge (~2 week average)|||Hours|Participants|Inter-Quartile Range|Median
820074|NCT01134900|Primary|Adverse Drug Events or Potential Adverse Drug Events|Our primary outcome measured the rate of AKI-related ADEs and pADEs. We defined pADEs as incidents with the potential for injury related to a drug, such as use of a non-steroidal anti-inflammatory drug for at least 24 hours, and ADEs as injuries resulting from the administration of a drug, such as a toxic vancomycin trough level or a bleed after administration of enoxaparin. We measured outcomes after completion of the inpatient encounter (either by death or discharge); pADEs or ADEs occurring after patient discharge were not included in the analysis.|Until patient discharge (~2 week average)|||Patient-Medication Pairs|Participants||Number
820075|NCT01134939|Secondary|Changes in the Laboratory Data (Haemoglobin) After 36 Months From Baseline|The changes in the laboratory data (Haemoglobin) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. .|Baseline and 36 months|Patients from TS with evaluable data for haemoglobin at baseline and at month 36.||g/dL||Standard Deviation|Mean
820076|NCT01134939|Secondary|Changes in the Laboratory Data (Creatinine) After 36 Months From Baseline|The changes in the laboratory data (Creatinine) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. .|Baseline and 36 months|Patients from TS with evaluable data for creatinine at baseline and at month 36.||mg/dL||Standard Deviation|Mean
820077|NCT01134939|Secondary|Changes in the Laboratory Data (Gamma-GT) After 36 Months From Baseline|The changes in the laboratory data (Gamma glutamyl transferase (Gamma GT)) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. .|Baseline and 36 months|Patients from TS with evaluable data for Gamma GT at baseline and at month 36.||U/L||Standard Deviation|Mean
820078|NCT01134939|Secondary|Changes in the Laboratory Data (AST) After 36 Months From Baseline|The changes in the laboratory data (Aspartate transminase (AST)) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. .|Baseline and 36 months|Patients from TS with evaluable data for the AST at baseline and at month 36.||U/L||Standard Deviation|Mean
820079|NCT01134939|Secondary|Changes in the Laboratory Data ( ALT) After 36 Months From Baseline|The changes in the laboratory data (Alanine transaminase (ALT)) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. .|Baseline and 36 months|Patients from TS with evaluable data for ALT at baseline and at month 36.||U/L||Standard Deviation|Mean
820080|NCT01134939|Secondary|Changes in the Laboratory Data (Blood Glucose) After 36 Months From Baseline|The changes in the laboratory data (Blood Glucose) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. .|Baseline and 36 months|Patients from TS with evaluable data for blood glucose at baseline and at month 36.||mg/dL||Standard Deviation|Mean
820081|NCT01134939|Secondary|Changes in the Laboratory Data (Triglycerides) After 36 Months From Baseline|The changes in the laboratory data (Triglycerides) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. .|Baseline and 36 months|Patients from TS with evaluable data for triglycerides at baseline and at month 36.||mg/dL||Standard Deviation|Mean
820082|NCT01134939|Secondary|Changes in the Laboratory Data (LDL Cholesterol) After 36 Months From Baseline|The changes in the laboratory data (Low density protein (LDL) Cholesterol) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. .|Baseline and 36 months|Patients from TS with evaluable data for LDL cholesterol at baseline and at month 36.||mg/dL||Standard Deviation|Mean
820083|NCT01134939|Secondary|Changes in the Laboratory Data (HDL Cholesterol) After 36 Months From Baseline|The changes in the laboratory data ( High density protein (HDL) Cholesterol) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. .|Baseline and 36 months|Patients from TS with evaluable data for HDL cholesterol at baseline and at month 36.||mg/dL||Standard Deviation|Mean
820084|NCT01134939|Secondary|Changes in the Laboratory Data (Total Cholesterol) After 36 Months From Baseline|The changes in the laboratory data (Total Cholesterol) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. .|Baseline and 36 months|Patients from TS with evaluable data for total cholesterol at baseline and at month 36.||mg/dL||Standard Deviation|Mean
820087|NCT01134939|Primary|Number of Patients With Virologic Response (VR) After 36 Months|"VR is defined as HIV viral load of < 50 copies/mL before month 36 and without subsequent rebound or change of ARV therapy. A rebound is defined by two consecutive measurements of VL ≥ 50 copies/ml, at least two weeks apart.
A change of ARV therapy is defined as a permanent discontinuation of Viramune®. A change in the background therapy due to toxicity or intolerance is not considered failure for the analysis. Therefore, a patient remains a treatment responder in this case if all other criteria are fulfilled. A rebound is defined by two consecutive measurements of VL ≥ 50 copies/ml, at least two weeks apart, after two consecutive measurements of VL< 50 copies/ml."|36 months|Patients from Full Analysis Set (FAS): This patient set includes all patients in the treated set who have analysable data in at least one efficacy endpoint.||participants|||Number
820088|NCT01134952|Secondary|Delta Triglyceride Fasting Level|Percent change determined 3 months after switch from MMF to SRL|3 month|Levels at appropriate times not available on 2 patients||percent change||Standard Deviation|Mean
820089|NCT01134952|Secondary|Delta Cholesterol Fasting Level|Percent change determined 3 months after switch from MMF to SRL|3 month|Levels not available for 2 patients||percent change||Standard Deviation|Mean
820090|NCT01134952|Secondary|Delta Platelet Count|Percent change determined 3 months after switch from MMF to SRL|3 month|Levels not available on 2 patients at appropriate time||percent change||Standard Deviation|Mean
820091|NCT01134952|Secondary|Delta Hemoglobin|Percent change determined 3 months after switch from MMF to SRL|3 month|Levels at appropriate times not available in 2 patients||percent change||Standard Deviation|Mean
820092|NCT01134952|Secondary|Delta Alanine Aminotransferase|Percent change determined 3 months after switch from MMF to SRL|3 month|Levels at appropriate time not available in 2 patients||percent change||Standard Deviation|Mean
820093|NCT01134952|Secondary|Delta Alkaline Phosphatase|Percent change determined 3 months after switch from MMF to SRL|3 month|Levels not available at appropriate times in 2 patients||percent change||Standard Deviation|Mean
820094|NCT01134952|Secondary|Delta Bilirubin|Percent change determined 3 months after switch from MMF to SRL|3 month|Levels available at correct time in only 7 patients||percent change||Standard Deviation|Mean
820095|NCT01134952|Secondary|Delta Tacrolimus Trough Level|Percent change determined 3 months after switch from MMF to SRL|3 month|2 patients did not have tacrolimus levels recorded during both time periods and are excluded||percent change||Standard Deviation|Mean
820096|NCT01134952|Secondary|Sirolimus Trough Level||3 month|||ng/ml||Standard Deviation|Mean
820097|NCT01134952|Secondary|Final Hepatitis C Viral Load|Percent change in HCV load determined 3 months after switch from SRL to MMF|3 month|||percent change||Standard Deviation|Mean
820098|NCT01134952|Primary|Delta Hepatitis C Viral Load|Percent change in HCV load determined 3 months after switch from MMF to SRL.|3 month|||percent change||Standard Deviation|Mean
820099|NCT01135017|Other Pre-specified|Overview of Adverse Events (AE)|AE are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.|from first study drug intake up to 10 days after the last study drug intake|All randomized and treated participants. Participants were considered according to the treatment actually received.||participants|||Number
820100|NCT01135017|Secondary|Incidence Rate of Electrical Cardioversion (or Overdrive Pacing)|"Electrical cardioversion is a procedure in which an electric shock is used to restore normal heart rhythm. Overdrive pacing is a procedure in which an artificial cardiac pacemaker is used to increase the heart rate in order to suppress certain arrhythmias.
Incidence rate of electrical cardioversion (or overdrive pacing) is expressed as the number of participants that was cardioverted or paced during the study."|12 weeks|Modified intent-to-treat population as previously defined||participants|||Number
820101|NCT01135017|Secondary|Atrial Fibrillation Severity Scale (AFSS) Scores|"The University of Toronto Atrial Fibrillation Severity Scale is an instrument to assess the subject-perceived AF burden and AF symptom severity. It consists in a questionnaire plus a scoring algorithm.
AF Burden score ranges from 3 to 30 and higher scores indicate greater AF burden.
AF symptoms severity score ranges from 0 to 35 and higher scores indicate extremely severe AF symptoms."|Baseline (before randomization) and 12 weeks after randomization|Modified intent-to-treat population as previously defined||units on a scale||Standard Deviation|Mean
820102|NCT01135017|Secondary|Average Ventricular Rate During AF Episodes|"Ventricular rates of AF episodes were obtained from pacemaker interrogation and EGM review.
The average ventricular rate during AF episodes in the 12-week treatment period was defined as the duration-weighted average of the ventricular rates collected at Week 4 and Week 12. It was calculated from the single available measurement when one measurement was missing."|Baseline (before randomization), 4 weeks and 12 weeks after randomization|Modified intent-to-treat population as previously defined||beats/min||Standard Deviation|Mean
820103|NCT01135017|Secondary|AF Burden During the First 4 Weeks of Treatment and After 4-week Treatment|AF burden at each pacemaker interrogation as evaluated centrally by the Pacemaker Core Lab|4 weeks and 12 weeks after randomization|Modified intent-to-treat population as previously defined||percent time in AF||95% Confidence Interval|Geometric Mean
820104|NCT01135017|Primary|Atrial Fibrillation (AF) Burden During the 12-week Treatment Period|"AF burden, defined as the percent time a subject is in AF, was evaluated centrally by a Pacemaker Core Lab based on pacemaker interrogation reports including Electrogram (EGM) data provided by the Investigator.
AF burden during the 12-week treatment period was defined as the duration-weighted average of AF burden collected at Week 4 and Week 12. It was calculated from the single available measurement when one measurement was missing."|Baseline (before randomization), 4 weeks and 12 weeks after randomization|The analysis included all randomized and treated participants with post-baseline AF burden assessment. Participants were included in the treatment group to which they were randomized (Modified Intent-to-treat analysis).||percent time in AF||95% Confidence Interval|Geometric Mean
820105|NCT01135069|Primary|Improvement in Acne|Counting of acne lesions both inflammatory and non-inflammatory|12 weeks|||Percent change||Standard Deviation|Mean
820106|NCT01135134|Secondary|Change From Baseline in the Total Nasal Symptom Score at 1 Week|Total nasal symptom score was a composite of 4 symptoms (sneezing, rhinorrhea, nasal congestion, and nasal itching), each symptom was scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total score ranged from 0 to 12. The higher the score was, the more severe the symptoms were.|Baseline and 1 week|||score on a scale||Standard Error|Least Squares Mean
820107|NCT01135134|Primary|Change From Baseline in the Total Nasal Symptom Score at 2 Weeks|Total nasal symptom score was a composite of 4 symptoms (sneezing, rhinorrhea, nasal congestion, and nasal itching), each symptom was scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total score ranged from 0 to 12. The higher the score was, the more severe the symptoms were.|Baseline and 2 weeks (or discontinuation)|||score on a scale||Standard Error|Least Squares Mean
820108|NCT01135186|Secondary|Secondary Outcome Measures Will Include Change in Symptom Severity as Measured by the Patient Assessment of Gastrointestinal Disorder-Symptom Severity Index Disorders Symptom Severity Index (PAGI-SYM)|"Symptom severity as measured by the Patient Assessment of Upper Gastrointestinal Disorder- Symptom Severity Index. (PAGI-SYM)
The PAGI-SYM is compose of 20 questions.
Each question can be answered on a scale of 1-5 (below)
0 = none, 1=very mild, 2=mild, 3=moderate, 4=severe, 5=very severe
Cumulative scores were calculated by summing all 20 questions.
The minimum cumulative scores would be 0 while the maximum cumulative score would be 100
Once we calculated the cumulative score for each participant, we took the average of all the cumulative scores giving us the sample mean. This was done at baseline, week 4, and week 8.
Lower score indicates decreased symptom severity. Higher score indicates increased symptom severity."|Baseline, 4 Weeks, 8 Weeks|||units on a scale||Standard Deviation|Mean
820109|NCT01135186|Secondary|Secondary Outcome Measures Will Include Change in Quality of Life.|"Quality of life as impacted by patients with upper gastrointestinal disorders (PAGI-QOL)
The PAGI-QOl is composed of 30 questions.
Each question asks about the degree to which a patient’s quality of life is impacted by upper gastrointestinal disorders.
Questions measure quality of life impact on a scale of 1-5 listed below.
0=none of the time, 1=a little of the time, 2=some of the time, 3=a good bit of the time, 4= most of the time, 5= all of time
The 30 items are summed together for a cumulative PAGI-QOL score. The minimum cumulative score is “0” and the maximum score is “150.”
Once we calculated the cumulative score for each participant, we took the average of all participants cumulative scores giving us the sample mean. This was done at baseline, week 4, and week 8.
Lower scores indicate an improved overall quality of life. Higher scores indicate a diminished overall quality of life."|Baseline, 4 Weeks, 8 Weeks|||units on a scale||Standard Deviation|Mean
820110|NCT01135186|Secondary|Secondary Outcome Measures Will Include Change in Symptom Severity.|"Change in symptom severity over the past 2 weeks as measured by the patient reported Gastroparesis Cardinal Symptom Index (GCSI)
The GCSI is composed of 9 questions.
Each question asks about symptom severity on a scale of 1-5 listed below.
0=None 1= Very mild 2= Mild 3=Moderate 4=Severe 5= Very severe
The 9 scores are summed together for cumulative GCSI score. The minimum cumulative score is ‘”0” and the maximum cumulative score is “45.”
Once we calculated the cumulative score for each participant, we took the average of all participants cumulative scores giving us the sample mean. This was done at baseline, week 4, and week 8.
Higher total scores indicate higher symptom severity. Lower total scores indicate lower symptom severity."|Baseline, 4 Weeks, 8 Weeks|||units on a scale||Standard Deviation|Mean
820111|NCT01135186|Primary|Gastric Accommodation|"Gastric Accommodation refers to the reflexive relaxation of the upper stomach after swallowing as measured by the Satiety Test at baseline, 4 weeks, and 8 weeks.
Increased gastric accommodation is considered a positive outcome."|Baseline, 4 Weeks, 8 Weeks|||ml||Standard Deviation|Mean
820112|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Assessment of Macula Lutea of the Left Eye|The macula lutea of the left eye was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5. Pathological classification includes abnormal findings such as maculopathy, retinal pigmentation, macular degeneration, diabetic retinopathy, retinal hemorrhage or aneurysm. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in macula lutea classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows).|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.||participants|||Number
820113|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Assessment of Macula Lutea of the Right Eye|The macula lutea of the right eye was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5. Pathological classification includes abnormal findings such as maculopathy, retinal pigmentation, macular degeneration, diabetic retinopathy, retinal hemorrhage or aneurysm. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in macula lutea classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows).|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.||participants|||Number
820114|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Assessment of Retinal Blood Vessels of the Left Eye|The retinal blood vessels of the left eye were assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5. Pathological classification includes abnormal findings such as retinal vascular disorder, retinopathy, and retinal hemorrhage. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in retinal blood vessel classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows).|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.||participants|||Number
820115|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Assessment of Retinal Blood Vessels of the Right Eye|The retinal blood vessels of the right eye were assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5. Pathological classification includes abnormal findings such as retinal vascular disorder, retinopathy, and retinal hemorrhage. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in retinal blood vessel classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows).|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.||participants|||Number
820116|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Assessment of Optic Nerve and Papilla of the Left Eye|The optic nerve and papilla of the left eye was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5. Pathological classification includes abnormal findings such as optic nerve cupping, optic nerve cup/disc ratio, or glaucomatous optic disc atrophy. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in optic nerve/papilla classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows).|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.||participants|||Number
820117|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Assessment of Optic Nerve and Papilla of the Right Eye|The optic nerve and papilla of the right eye was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5. Pathological classification includes abnormal findings such as optic nerve cupping, optic nerve cup/disc ratio, or glaucomatous optic disc atrophy. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in optic nerve/papilla classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows).|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.||participants|||Number
820118|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Assessment of Retinal Aspect of the Left Eye|The retinal aspect of the left eye (such as color anomalies) was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5. Pathological classification includes abnormal findings such as deep red ocular fundus, fundus myopicus, retinal disorders, exudates or pigmentation. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in retinal aspect classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows).|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.||participants|||Number
820119|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Assessment of Retinal Aspect of the Right Eye|The retinal aspect of the right eye (such as color anomalies) was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5. Pathological classification includes abnormal findings such as deep red ocular fundus, fundus myopicus, retinal disorders, exudates or pigmentation. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in retinal aspect classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows).|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.||participants|||Number
820120|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Vitreous Body Assessment of Left Eye|"The vitreous body of the left eye was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5.
Pathological classification includes abnormal findings such as myodesopsia, vitreous opacities, degeneration, detachment or prolapse. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in vitreous body classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows)."|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.||participants|||Number
820121|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Vitreous Body Assessment of Right Eye|"The vitreous body of the right eye was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5.
Pathological classification includes abnormal findings such as myodesopsia, vitreous opacities, degeneration, detachment or prolapse. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in vitreous body classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows)."|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.||participants|||Number
820122|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Lens Assessment of Left Eye|"The lens of the left eye was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5.
Pathological classification includes abnormal findings such as cataracts, lenticular opacities, vacuoles or pseudophakia. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in lens classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows)."|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.||participants|||Number
820123|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Lens Assessment of Right Eye|"The lens of the right eye was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5.
Pathological classification includes abnormal findings such as cataracts, lenticular opacities, vacuoles or pseudophakia. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in lens classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows)."|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.||participants|||Number
820124|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Cornea Assessment of Left Eye|The cornea of the left eye was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5. Pathological classification includes abnormal findings such as cataracts, corneal degeneration, opacity, scars or deposits. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in corneal classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows).|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.||participants|||Number
820125|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Cornea Assessment of Right Eye|The cornea of the right eye was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5. Pathological classification includes abnormal findings such as cataracts, corneal degeneration, opacity, scars or deposits. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in corneal classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows).|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.||participants|||Number
820126|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Color Vision|Color vision was assessed by an Ophthalmologist and classified as normal or pathological. Pathological findings include abnormal color vision tests, color blindness and anomalous quotient. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in color vision classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows).|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.||participants|||Number
820222|NCT01141569|Secondary|Tumor Control Rate (CR + PR + SD)|Tumor control rate is defined as the sum of objective response rate (CR+PR) and stable disease (SD) rate.|Up to 12 months|||Participants|||Count of Participants
820127|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Accommodation|Accommodation is the adjustment of the focal length of the eye lens to keep an object in focus on the retina as its distance from the eye varies, and is measured in diopters: Diopters = 1/(focal length).|Baseline and Year 5|Safety analysis where data were available. Last observation carried forward was utilized.||diopters||Standard Deviation|Mean
820128|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Adaptation With Glare|"Adaptation is the ability of the eye to adjust to various levels of darkness and light. Normal and pathological status of adaptation with glare was defined as follows:
Normal status: Contrast between 1:0.05 and 1:23.5.
Pathological status: Contrast = 0 or contrast > 1:23.5.
The shift table below summarizes the individual transitions in the classification of adaptation with glare between Baseline (depicted in the columns) and Year 5 (depicted in the rows)."|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.||participants|||Number
820129|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Adaptation Without Glare|"Adaptation is the ability of the eye to adjust to various levels of darkness and light. Normal and pathological status of adaptation without glare was defined as follows:
Normal status: Contrast between 1:0.05 and 1:23.5.
Pathological status: Contrast = 0 or contrast > 1:23.5.
The shift table below summarizes the individual transitions in the classification of adaptation without glare between Baseline (depicted in the columns) and Year 5 (depicted in the rows)."|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.||participants|||Number
820130|NCT01135368|Secondary|Ophthalmologic Examination - Visual Acuity|Visual Acuity was measured using the Snellen eye chart at a distance of 6 meters. Acuity is expressed as a ratio of the test distance (6 M) / the distance the average eye can see the letters on a certain line of the eye chart. Visual acuity of 1 is normal; an individual with acuity of 0.5 could only recognize an object at half the distance compared to an individual with normal acuity.|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.||ratio||Standard Deviation|Mean
820131|NCT01135368|Secondary|Change From Baseline in Blood Analysis - Follicle Stimulating Hormone|The change between follicle stimulating hormone (FSH) measured at year 5 in males including final visit and follicle stimulating hormone measured at baseline.|Baseline and Year 5.|Safety analysis set, including all male participants who received any study medication. Last observation carried forward was utilized.||IU/L||Standard Deviation|Mean
820132|NCT01135368|Secondary|Change From Baseline in Blood Analysis - Luteinizing Hormone|The change between luteinizing hormone measured at year 5 in males including final visit and luteinizing hormone measured at baseline.|Baseline and Year 5|Safety analysis set, including all male participants who received any study medication. Last observation carried forward was utilized.||IU/L||Standard Deviation|Mean
820133|NCT01135368|Secondary|Change From Baseline in Blood Analysis - Testosterone|The change between testosterone measured at year 5 in males including final visit and Testosterone measured at baseline.|Baseline and Year 5|Safety analysis set, including all male participants who received any study medication. Last observation carried forward was utilized.||µg/L||Standard Deviation|Mean
820134|NCT01135368|Secondary|Change From Baseline in Corpus Intestinal Metaplasia|Intestinal metaplasia was assessed by biopsy and histopathological examination of the corpus and classified according to the Sydney classification as mild, moderate, severe or none. The shift table below summarizes the individual transitions in intestinal metaplasia classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows).|Baseline and Year 5|Safety analysis set, including all participants who received any study medication. Last observation carried forward was utilized.||participants|||Number
820135|NCT01135368|Secondary|Change From Baseline in Antrum Intestinal Metaplasia|Intestinal metaplasia was assessed by biopsy and histopathological examination of the antrum and classified according to the Sydney classification as mild, moderate, severe or none. The shift table below summarizes the individual transitions in intestinal metaplasia classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows).|Baseline and Year 5|Safety analysis set, including all participants who received any study medication. Last observation carried forward was utilized.||participants|||Number
820136|NCT01135368|Secondary|Change From Baseline in Corpus Chronic Inflammation Score|Chronic inflammation of the corpus was assessed by histopathology and graded according to the Sydney classification: 0 = None; 1 = mild; 2 = moderate; 3 = Severe.|Baseline and Year 5|Safety analysis set, including all participants who received any study medication. Last observation carried forward was utilized.||scores on a scale||Standard Deviation|Mean
820137|NCT01135368|Secondary|Change From Baseline in Average Antrum Chronic Inflammation Score|Chronic inflammation of the antrum was assessed by histopathology and graded according to the Sydney classification: 0 = None; 1 = mild; 2 = moderate; 3 = Severe|Baseline and Year 5|Safety analysis set, including all participants who received any study medication. Last observation carried forward was utilized.||scores on a scale||Standard Deviation|Mean
820138|NCT01135368|Secondary|Change From Baseline in Corpus Atrophy|Atrophy was assessed by histopathological examination of cells biopsied from the corpus and classified according to the Sydney classification as mild, moderate, severe or none. The shift table below summarizes the individual transitions in atrophy classification (mild, moderate, severe or none) between Baseline (depicted in the columns) and Year 5 (depicted in the rows).|Baseline and Year 5|Safety analysis set, including all participants who received any study medication. Last observation carried forward was utilized.||participants|||Number
820139|NCT01135368|Secondary|Change From Baseline in Antrum Atrophy|Atrophy was assessed by histopathological examination of cells biopsied from the antrum and classified according to the Sydney classification as mild, moderate, severe or none. The shift table below summarizes the individual transitions in atrophy classification (mild, moderate, severe or none) between Baseline (depicted in the columns) and Year 5 (depicted in the rows).|Baseline and Year 5|Safety analysis set, including all participants who received any study medication. Last observation carried forward was utilized.||participants|||Number
820223|NCT01141569|Secondary|Rate of Disease Stabilizations|Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study|Up to 12 months|Number of patients who had Stable disease||participants|||Number
820140|NCT01135368|Secondary|Change From Baseline in Enterochromaffin-like Cell Hyperplasia|"Enterochromaffin-like (ECL) cells were evaluated and classified by histopathological examinations as Normal, Simple (diffuse) hyperplasia, or Linear, chain producing hyperplasia.
The shift table below summarizes the individual transitions in ECL-cell classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows) for all patients."|Baseline and Year 5|Safety analysis set, including all participants who received any study medication. Last observation carried forward was utilized.||participants|||Number
820141|NCT01135368|Primary|Change From Baseline in Endoscopic Healing of Erosive Reflux Disease as Assessed by Endoscopy|Los Angeles Classification is used to grade the extension of changes in the oesophagus induced by reflux disease (Grade 0: normal aspect of mucosa; Grade A: ≥1 mucosal breaks no longer than 5 mm; Grade B: ≥1 mucosal breaks >5 mm long; Grade C: mucosal breaks extending between tops of two or more mucosal folds but are <75% of the circumference; Grade D: mucosal breaks ≥75% of the circumference). Healed defined as anything less than Grade A criteria. The shift table below summarizes the individual transitions in Los Angeles classification between Baseline (table columns) and Week 8 (table rows).|Baseline and Week 8|Intent to treat population, including all patients who received at least one dose of study medication and had a subsequent rating of the primary efficacy variable.||participants|||Number
820142|NCT01135368|Primary|Change From Baseline in Reflux Disease Symptom - Cough & Sore Throat|Cough and sore throat symptoms were assessed by the Investigator at Baseline and the Week 8 visit. The shift table below summarizes the individual transitions in symptom intensity (mild, moderate, severe or none) between Baseline (depicted in the columns) and Week 8 (depicted in the rows) for all patients.|Baseline and Week 8|Intent to treat population, including all patients who received at least one dose of study medication and had a subsequent rating of the primary efficacy variable.||participants|||Number
820143|NCT01135368|Primary|Change From Baseline in Reflux Disease Symptom - Nausea & Vomiting|Nausea and vomiting symptoms were assessed by the Investigator at Baseline and the Week 8 visit. The shift table below summarizes the individual transitions in symptom intensity (mild, moderate, severe or none) between Baseline (depicted in the columns) and Week 8 (depicted in the rows) for all patients.|Baseline and Week 8|Intent to treat population, including all patients who received at least one dose of study medication and had a subsequent rating of the primary efficacy variable.||participants|||Number
820144|NCT01135368|Primary|Change From Baseline in Reflux Disease Symptom - Pain in Upper Abdomen|Pain in the upper abdomen symptoms were assessed by the Investigator at Baseline and the Week 8 visit. The shift table below summarizes the individual transitions in symptom intensity (mild, moderate, severe or none) between Baseline (depicted in the columns) and Week 8 (depicted in the rows) for all patients.|Baseline and Week 8|Intent to treat population, including all patients who received at least one dose of study medication and had a subsequent rating of the primary efficacy variable.||participants|||Number
820145|NCT01135368|Primary|Change From Baseline in Reflux Disease Symptom - Difficulty Swallowing|Difficulty swallowing symptoms were assessed by the Investigator at Baseline and the Week 8 visit. The shift table below summarizes the individual transitions in symptom intensity (mild, moderate, severe or none) between Baseline (depicted in the columns) and Week 8 (depicted in the rows) for all patients.|Baseline and Week 8|Intent to treat population, including all patients who received at least one dose of study medication and had a subsequent rating of the primary efficacy variable.||participants|||Number
820146|NCT01135368|Primary|Change From Baseline in Reflux Disease Symptoms - Acid Regurgitation|Acid regurgitation symptoms were assessed by the Investigator at Baseline and the Week 8 visit. The shift table below summarizes the individual transitions in symptom intensity (mild, moderate, severe or none) between Baseline (depicted in the columns) and Week 8 (depicted in the rows) for all patients.|Baseline and Week 8|Intent to treat population, including all patients who received at least one dose of study medication and had a subsequent rating of the primary efficacy variable.||participants|||Number
820147|NCT01135368|Primary|Change From Baseline in Reflux Disease Symptom - Heartburn|Heartburn symptoms were assessed by the Investigator at Baseline and the Week 8 visit. The shift table below summarizes the individual transitions in symptom intensity (mild, moderate, severe or none) between Baseline (depicted in the columns) and Week 8 (depicted in the rows) for all patients.|Baseline and Week 8|Intent to treat population, including all patients who received at least one dose of study medication and had a subsequent rating of the primary efficacy variable.||participants|||Number
820148|NCT01135381|Secondary|Community Tenure|The number of days a patient spends in the home versus the hospital at 30 days.|30 days|||days||Standard Deviation|Mean
820149|NCT01135381|Secondary|Rehospitalizations at 90 Days||90 days|||participants|||Number
820150|NCT01135381|Primary|Re-hospitalizations||During the 30days after discharge|||participants|||Number
820151|NCT01135420|Primary|Readiness to Attend Substance Use Disorder Continuing Care|Readiness to attend substance use disorder continuing care; scale range=0-4, with 0=not ready to do; 4=already doing; higher scores indicate a better outcome.|3 months post-intervention|||units on a scale||Standard Deviation|Mean
820152|NCT01135498|Secondary|Overall Survival (OS)|Overall survival was defined as the time from the date of informed consent to the date of death (regardless of the cause of death). There was no restriction; survival was calculated until the date of death, even if another line of treatment was received, or until the date censored (last contact with the participant even if drugs different from the study treatment schedule were received). For all participants, survival information was collected until the date of death, the last contact, or the last follow-up.|From study start up to approximately 4 years|ITT population||months||95% Confidence Interval|Median
820153|NCT01135498|Primary|Progression-Free Survival|Progression-free survival was defined as the time from the date of informed consent until the date when the participant had progression of disease or died from disease progression. Participants who received surgical treatment after treatment ended were censored at the time of surgery. Participants who left the study for reasons other than progression of the disease were censored on the date on which they received a later antitumor therapy (with the same or different drugs, radiotherapy, or surgery).|From study start up to approximately 4 years|ITT population||months||95% Confidence Interval|Median
820154|NCT01135498|Secondary|Percentage of Participants Who Died||From study start up to approximately 4 years|ITT population||percentage of participants|||Number
820155|NCT01135498|Secondary|Percentage of Participants Achieving Disease Control (CR, PR, or No Change [NC])|Percent of participants with confirmed CR, PR, or NC. Per RECIST version (v)1.0: CR was defined as disappearance of all target and non-target lesions. PR was defined as ≥30% decrease in sum of longest diameters of target lesions taking as reference baseline sum longest diameters associated to non-progressive disease response for non-target lesions. NC was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference smallest sum of longest dimensions since treatment started associated to non-progressive disease response for non-target lesions.|From study start up to approximately 4 years|Response-Evaluable population||percentage of participants|||Number
820156|NCT01135498|Secondary|Percentage of Participants Achieving Objective Response (Complete Response [CR] or Partial Response [PR])|Percentage of participants with objective response based assessment of CR or PR according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal (short axis less than [<]10 millimeters [mm]) and no new lesions. PR was defined as greater than or equal to (≥)30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.|From study start up to approximately 4 years|Response-Evaluable population: all enrolled participants who received at least 3 cycles of treatment, had all baseline lesions evaluated at least once after receiving the third cycle (using same technique as at baseline), and were without major violations of the study protocol.||percentage of participants|||Number
820157|NCT01135498|Primary|Percentage of Participants With Disease Progression or Death|Disease progression was defined according to Response Evaluation Criteria in Solid Tumors (RECIST) as a 20 percent (%) increase in the sum of the longest diameter of target lesions, or a measureable increase in a non-target lesion, or the appearance of new lesions.|Start of study to approximately 4 years|ITT population||percentage of participants|||Number
820158|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Total Protein|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.
Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.
n=number of analyzed with sufficient quantity for testing."||mcg/mL||Standard Deviation|Mean
820159|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Lipocalin 1|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.
Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.
n=number of analyzed with sufficient quantity for testing."||mcg/mL||Standard Deviation|Mean
820160|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 1|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.
Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.
n=number of analyzed with sufficient quantity for testing."||Relative unit/mL||Standard Deviation|Mean
820161|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline - Mucin 16 Carbohydrate Antigen 125|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.
Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of Intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.
n=number of analyzed with sufficient quantity for testing."||Relative unit/mL||Standard Deviation|Mean
820162|NCT01135511|Other Pre-specified|Number of Participants Evaluated for Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 4|"Number of analyzed with sufficient quantity for analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.
Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline."|Week 4 and 8|A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.||Participants|||Number
820163|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 5AC|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.
Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.
n=number of analyzed with sufficient quantity for testing."||Relative unit/mL||Standard Deviation|Mean
820164|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Albumin|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.
Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.
n=number of analyzed with sufficient quantity for testing."||mcg/mL||Standard Deviation|Mean
820165|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Epidermal Growth Factor|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.
Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.
n=number of analyzed with sufficient quantity for testing."||pg/mL||Standard Deviation|Mean
820166|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Tissue Inhibitor of Metalloproteinase 1 (TIMP-1)|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.
Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.
n=number of analyzed with sufficient quantity for testing."||ng/mL||Standard Deviation|Mean
820167|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-C Motif) Ligand 5 (CCL5) (Alias Regulated on Activation, Normal T Cell Expressed, and Secreted: RANTES)|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.
Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.
n=number of analyzed with sufficient quantity for testing."||pg/mL||Standard Deviation|Mean
820168|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine ( C-C Motif) Ligand 20 (CCL20) (Alias Macrophage Inflammatory Protein 3 Alpha: MIP3A)|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.
Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.
n=number of analyzed with sufficient quantity for testing."||pg/mL||Standard Deviation|Mean
820169|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-X-C Motif) Ligand 9 (CXCL9) (Alias Monokine Induced by Gamma Interferon: MIG)|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.
Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.
n=number of analyzed with sufficient quantity for testing."||pg/mL||Standard Deviation|Mean
820170|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-X-C Motif) Ligand 10 (CXCL10) (Alias Gamma-Interferon Inducible Protein 10: IP10)|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.
Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.
n=number of analyzed with sufficient quantity for testing."||pg/mL||Standard Deviation|Mean
820171|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-17A|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.
Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.
n=number of analyzed with sufficient quantity for testing."||pg/mL||Standard Deviation|Mean
820172|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Alpha-1 Antitrypsin|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.
Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.
n=number of analyzed with sufficient quantity for testing."||ng/mL||Standard Deviation|Mean
820173|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Vascular Endothelial Growth Factor|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.
Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.
n=number of analyzed with sufficient quantity for testing."||pg/mL||Standard Deviation|Mean
820174|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Matrix Metalloproteinase-9|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.
Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.
n=number of analyzed with sufficient quantity for testing."||ng/mL||Standard Deviation|Mean
820175|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Matrix Metalloproteinase-3|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.
Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.
n=number of analyzed with sufficient quantity for testing."||ng/mL||Standard Deviation|Mean
820176|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-23|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.
Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.
n=number of analyzed with sufficient quantity for testing."||ng/mL||Standard Deviation|Mean
820177|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-1 Receptor Antagonist|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.
Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.
n=number of analyzed with sufficient quantity for testing."||pg/mL||Standard Deviation|Mean
820178|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-1 Beta|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.
Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.
n=number of analyzed with sufficient quantity for testing."||pg/mL||Standard Deviation|Mean
820179|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-12 P40/P35 Heterodimer (IL-12P70)|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.
Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.
n=number of analyzed with sufficient quantity for testing."||pg/mL||Standard Deviation|Mean
820180|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Monocyte Chemotactic Protein 1|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.
Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.
n=number of analyzed with sufficient quantity for testing."||pg/mL||Standard Deviation|Mean
820181|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-8|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.
Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.
n=number of analyzed with sufficient quantity for testing."||pg/mL||Standard Deviation|Mean
820182|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-7|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.
Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.
n=number of analyzed with sufficient quantity for testing."||pg/mL||Standard Deviation|Mean
820183|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-6|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.
Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.
n=number of analyzed with sufficient quantity for testing."||pg/mL||Standard Deviation|Mean
820184|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-18|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.
Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.
n=number of analyzed with sufficient quantity for testing."||pg/mL||Standard Deviation|Mean
820185|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Apolipoprotein C-3|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.
Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.
n=number of analyzed with sufficient quantity for testing."||ng/mL||Standard Deviation|Mean
820186|NCT01135511|Other Pre-specified|Change in Expression of Inflammatory Markers on Conjunctival Cells From Baseline: Percentage of Human Leukocyte Antigen (HLA)-DR Positive for Study Eye|"Percentage of conjunctival epithelial cells that were positive with HLA-DR expression was calculated as HLA-DR Positive.
Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline."|Baseline, Week 4 and 8|A subset of intent-to-treat population collected impression cytology samples from both eyes at screening, week 4 and week 8.||Percentage of positive cells||Standard Deviation|Mean
820187|NCT01135511|Other Pre-specified|Change in Expression of Inflammatory Markers on Conjunctival Cells From Baseline: Human Leukocyte Antigen-DR Antibody Bound Per Cell for Study Eye|"The average level of HLA-DR expression per cell was reported as HLA-DR antibody bound per cell (ABC).
Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Change = value at observation minus value at baseline."|Baseline, Week 4 and 8|A subset of intent-to-treat population collected impression cytology samples from both eyes at screening, week 4 and week 8.||Antibodies bound per cell||Standard Deviation|Mean
820224|NCT01141569|Secondary|Progression-free Survival Rate|Progression-free survival is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.|From start of treatment to time of progression or death, whichever occurs first, assessed up to 12 months|||months||95% Confidence Interval|Median
820188|NCT01135511|Secondary|Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale|"Ocular tolerability was assessed for the 5 symptoms (burning sensation, blurred vision, ocular discomfort, pain, tearing), based on a 4-point severity scale (none, minor, moderate, and severe).
Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline."|8 weeks|Safety analysis set: Participants who received at least 1 dose of study treatment.||Participants|||Number
820189|NCT01135511|Secondary|Number of Participants With Nonocular Adverse Events (AEs) by Severity|Counts of participants who had treatment-emergent nonocular AEs, defined as newly occurring or worsening after first dose. Participants with multiple occurrences of an AE within a category were counted once within the category.|8 weeks|Safety analysis set: Participants who received at least 1 dose of study treatment.||Participants|||Number
820190|NCT01135511|Secondary|Number of Participants With Ocular Adverse Events (AEs)by Severity|Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Ocular AEs are the events which are localized in the ocular region. Participants with multiple occurrences of an AE within a category were counted once within the category.|8 weeks|Safety analysis set: Participants who received at least 1 dose of study treatment.||Participants|||Number
820191|NCT01135511|Secondary|Number of Participants Evaluable for Time to Achievement of ≥3 Unit Decrease in OCI Scores|The OCI is a validated instrument developed to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point rating scale (0 [Never] to 6 [Always], or 0 [Never had it] to 6 [Severe]). Negative change from baseline indicated improvement. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.|Week 8|Intent-to-treat population: Participants who received at least 1 dose of study treatment.||Participants|||Number
820192|NCT01135511|Secondary|Number of Participants Evaluable for Time to Achievement of ≥10 mm Schirmer Wetting Score Without Anesthesia for Study Eye|"The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac.
Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline."|Week 8|Intent-to-treat population: Participants who received at least 1 dose of study treatment.||Participants|||Number
820193|NCT01135511|Secondary|Number of Participants Evaluable for Time to Achievement of 100% Clearing of Corneal Staining for Study Eye|"Based on the National Eye Institute (NEI) dry eye clinical trials workshop, the cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale. The maximum possible staining score is 15, higher score indicated greater staining.
100% Clearing of Corneal Staining means corneal staining score = 0. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline."|Week 8|Intent-to-treat population: Participants who received at least 1 dose of study treatment.||Participants|||Number
820194|NCT01135511|Secondary|Percentage of Participants Demonstrating ≥10 Unit Decrease in Ocular Surface Disease Index (OSDI) Total Score From Baseline|"The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers.
The 12 items of the OSDI questionnaire were graded on a scale of 0 [none of the time] to 4 [all of the time]. The total OSDI score was then calculated on the basis of the following formula: OSDI=[(sum of scores for all questions answered) × 100]/[(total number of questions answered) × 4].
The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability.
Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline."|Week 1, 2, 4 and 8|Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.||Percentage of participants|||Number
820195|NCT01135511|Secondary|Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Environmental Triggers|"The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers.
The 12 items of the OSDI questionnaire were graded on a scale of 0 [none of the time] to 4 [all of the time]. The subscale OSDI score was then calculated on the basis of the following formula: OSDI=[(sum of scores for questions 10 to 12 answered) × 100]/[(total number of questions 10 to 12 answered) × 4].
The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability.
Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Change: score at observation minus score at baseline. Negative change from baseline indicated improvement."|Baseline, Week 1, 2, 4 and 8|Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.||Units on a scale||Standard Deviation|Mean
820196|NCT01135511|Secondary|Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Vision-Related Function|"The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers.
The 12 items of the OSDI questionnaire were graded on a scale of 0 [none of the time] to 4 [all of the time]. The subscale OSDI score was then calculated on the basis of the following formula: OSDI=[(sum of scores for questions 4 to 9 answered) × 100]/[(total number of questions 4 to 9 answered) × 4].
Thus, the OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability.
Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Change: score at observation minus score at baseline. Negative change from baseline indicated improvement."|Baseline, Week 1, 2, 4 and 8|Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.||Units on a scale||Standard Deviation|Mean
820225|NCT01141569|Secondary|Frequency and Severity of Adverse Events|Tabulated using counts and proportions detailing frequently occurring, serious and severe events of interest.|Up to 12 months|Number analyzed is number of participants who experienced the adverse event.||Participants|||Count of Participants
820226|NCT01141569|Secondary|Time to Progression|Time to Progression is duration of time from start of treatment to time of progression|Up to 12 months|||months||95% Confidence Interval|Median
820197|NCT01135511|Secondary|Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Ocular Symptoms|"The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers.
The 12 items of the OSDI questionnaire were graded on a scale of 0 [the none of time] to 4 [all of the time]. The subscale OSDI score was then calculated on the basis of the following formula: OSDI=[(sum of scores for questions 1 to 3 answered) × 100]/[(total number of questions 1 to 3 answered) × 4].
The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability.
Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Change: score at observation minus score at baseline. Negative change from baseline indicated improvement."|Baseline, Week 1, 2, 4 and 8|Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.||Units on a scale||Standard Deviation|Mean
820198|NCT01135511|Secondary|Changes in the Ocular Surface Disease Index (OSDI) Total Score From Baseline|"The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers.
The 12 items of the OSDI questionnaire were graded on a scale of 0 [none of the time] to 4 [all of the time]. The total OSDI score was then calculated on the basis of the following formula: OSDI=[(sum of scores for all questions answered) × 100]/[(total number of questions answered) × 4].
The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability.
Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Change: score at observation minus score at baseline. Negative change from baseline indicated improvement."|Baseline, Week 1, 2, 4 and 8|Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.||Units on a scale||Standard Deviation|Mean
820199|NCT01135511|Secondary|Number of Participants Demonstrating at Least ≥3 Unit Decrease in Ocular Comfort Index (OCI) Total Score From Baseline|"The OCI is a validated instrument developed to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point rating scale (0 [Never] to 6 [Always], or 0 [Never had it] to 6 [Severe]). Total score ranged from 0 (none) to 72 (severe symptoms). A higher score indicates more severe dry eye symptoms.
Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Change = scores at observation minus score at baseline. Negative change from baseline indicated improvement."|Week 1, 2, 4 and 8|Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.||Participants|||Number
820200|NCT01135511|Secondary|Changes in the Ocular Comfort Index (OCI) Total Score From Baseline|"The OCI is a validated instrument developed to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point rating scale (0 [Never] to 6 [Always], or 0 [Never had it] to 6 [Severe]). Total score ranged from 0 (none) to 72 (severe symptoms). A higher score indicates more severe dry eye symptoms.
Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Change: score at observation minus score at baseline. Negative change from baseline indicated improvement."|Baseline, Week 1, 2, 4 and 8|Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.||Units on a scale||Standard Deviation|Mean
820201|NCT01135511|Secondary|Number of Participants Who Increase of ≥10 mm From Baseline in Schirmer Test Value Without Anesthesia for Study Eye|"The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. The length of wetting (distance from the notch) was recorded in millimeters (to the nearest 0.5 mm). If the wetting line was oblique, the halfway point was used.
Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline."|Week 1, 2, 4 and 8|Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.||Participants|||Number
820202|NCT01135511|Secondary|Percentage of Participants Who Achieve ≥10 mm Schirmer Test Value Without Anesthesia for Study Eye|"The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. The length of wetting (distance from the notch) was recorded in millimeters (to the nearest 0.5 mm). If the wetting line was oblique, the halfway point was used.
Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline."|Week 1, 2, 4 and 8|Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data at Week 8.||Percentage of participants|||Number
820203|NCT01135511|Secondary|Changes in Schirmer Test Values Without Anesthesia for Study Eye From Baseline|"The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. The length of wetting (distance from the notch) was recorded in millimeters (to the nearest 0.5 mm). If the wetting line was oblique, the halfway point was used.
Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Change: value at observation minus value at baseline. Positive change from baseline indicated improvement."|Baseline, Week 1, 2, 4 and 8|Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.||Millimeters||Standard Deviation|Mean
820204|NCT01135511|Secondary|Changes in Tear Break Up Time (TBUT) for Study Eye From Baseline|"TBUT is the interval between the last complete blink and the first appearance of a dry spot, or disruption in the tear film. Using a stopwatch, the time between last complete blink and first appearance of dry spot was recorded.
Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Change: value at observation minus value at baseline. Positive change from baseline indicated improvement."|Baseline, Week 1, 2, 4 and 8|Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.||Seconds||Standard Deviation|Mean
820247|NCT01142323|Secondary|Interleukin 6|Interleukin 6 will be measured at entry and end of study as an indirect measure of PPAR alpha pathway activation.|6 months||||||
820205|NCT01135511|Secondary|Changes in Conjunctival Staining Scores (Interpalpebral) for Study Eye From Baseline|"Based on the Oxford grading system, the bulbar conjunctiva of each eye was divided into 2 different zones (nasal and temporal). The nasal and temporal bulbar conjunctival zones were each graded independently using a 6-point scale (0 [Absent] to 5 [Severe]). Total score ranged from 0 (Absent) to 10 (severe), higher score=higher damage to eyes due to dryness. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Change = scores at observation minus score at baseline. Negative change from baseline indicated improvement."|Baseline, Week 1, 2, 4 and 8|Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.||Units on a scale||Standard Deviation|Mean
820206|NCT01135511|Secondary|Percentage of Participants Demonstrating 100 Percent Clearing of Corneal Staining for Study Eye|"Percentage of participants demonstrating corneal staining score = 0 which indicates no damage in corneal surface.
Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline."|Week 1, 2, 4 and 8|Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data at Week 8.||Percentage of participants|||Number
820207|NCT01135511|Secondary|Changes in Corneal Staining Scores for Study Eye From Baseline|"Based on the National Eye Institute (NEI) dry eye clinical trials workshop, the cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale:0=none, 1=slight, 2=moderate, 3=severe. Sum of scores of each zone led to total score. Total score range: 0 to 15, higher score indicated greater staining. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Change: score at observation minus score at baseline. Negative change from baseline indicated improvement."|Baseline, Week 1, 2 and 4|Intent-to-treat population: Participants who received at least 1 dose of study treatment.||Units on a scale||Standard Deviation|Mean
820208|NCT01135511|Primary|Changes in Corneal Staining Scores for Study Eye From Baseline at Week 8|"Based on the National Eye Institute (NEI) dry eye clinical trials workshop, the cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale:0=none, 1=slight, 2=moderate, 3=severe. Sum of scores of each zone led to total score. Total score range: 0 to 15, higher score indicated greater staining. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Change: score at observation minus score at baseline. Negative change from baseline indicated improvement."|Baseline, Week 8|Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.||Units on a scale||Standard Deviation|Mean
820209|NCT01135524|Primary|The Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Safety was assessed using reports of adverse events, clinical laboratory results, findings from physical examinations, and vital sign measurements.|52 weeks|The Extension Safety Population (N = 196) consisted of all subjects who received at least 1 dose of the open-label BTDS extension study drug, and had at least 1 safety assessment during the extension phase.||participants|||Number
820210|NCT01135914|Secondary|Time Trade-Off Questionnaire - 25 (TTO) Composite Score at Month 12|(TTO) questionnaire was used to help determine the patients’ health utility. Reported health utility represents the patients’ quality of life at the current health state, and is a cardinal value that ranges from 0 (worst possible health or death) to 1 (best possible health). In this questionnaire, patients were first asked to estimate their remaining life expectancy. Second, the patients were presented with a hypothetical situation where a technology existed that could permanently return their vision to normal. This technology would always work, but would decrease their length of survival. Patients were then asked how much of their remaining life expectancy, if any, they would be willing to trade in return for use of the technology and thus for normal vision. The principle of this measure is that if patients were content with their current vision status (i.e., have a utility value of 1.0), they would not want to trade any of their remaining life years to improve their vision.|12 month|ITT defined as all patients receiving at least one dose of either study treatment for monotherapy treatment arms, or one of the two study treatments for the combination therapy arm, and having at least 1 post-baseline assessment. Patients from one study site were excluded from ITT. Patients with both baseline and 12 month data were included||Units on a scale||Standard Deviation|Mean
820211|NCT01135914|Secondary|EuroQoL (EQ-5D) Utility Score at Month 12|The Euro Quality of Life Questionnaire (EQ-5D) standardized instrument was utilized to measure health outcomes related to 5 dimensions, namely: mobility, self-care, usual activities, pain-discomfort, and anxiety/depression. The possible range for each dimension was 1 to 3, where 1=“no problems”, 2=”some problems” and 3=”extreme problems”. Missing values were not imputed. Using the scoring algorithm derived from the Canadian value sets (Bansback et al., 2012), a utility score for a patient was calculated based on the EQ-5D responses for a given time-point at which the questionnaire was presented to the patient. This mean EQ-5D utility score ranged between 0 (worst health) to 1 (perfect health).|12 month|ITT defined as all patients receiving at least one dose of either study treatment for monotherapy treatment arms, or one of the two study treatments for the combination therapy arm, and having at least 1 post-baseline assessment. Patients from one study site were excluded from ITT. Patients with both baseline and 12 month data were included||Units on a scale||Standard Deviation|Mean
820227|NCT01141569|Primary|Objective Response Rate (PR + CR) Using RECIST|"Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters"|Up to 12 months|Patients that had PR or CR (Objective response)||participants|||Number
820228|NCT01141595|Primary|Preschool Language Scales|Change in the raw score from baseline of the Preschool Language Scales over the 16 week period. The raw score was measured at baseline, 8 weeks and 16 weeks after starting treatment and the change over the 16 week period from baseline to the end of the study was calculated. There was no imputed data and the analysis was as treated. The raw score ranged from 0 to 130. Higher scores indicate better performance.|16 weeks|The number of participants with data available that completed at least the 16 week assessment.||Raw score units / 16 weeks||Standard Deviation|Mean
820248|NCT01142323|Secondary|Interleukin 1|Interleukin 1 will be measured at entry and end of study as an indirect measure of peroxisome proliferator- activated receptor alpha (PPAR- alpha) pathway activation.|6 months||||||
820212|NCT01135914|Secondary|National Eye Institute Visual Functioning Questionnaire - 25 (VFQ-25) Composite Score at Month 12|The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) was used to measure the influence of visual disability and visual symptoms on general health domains. The 12 subscales in the VFQ-25 are general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. For each question, the patient was asked to rate their condition on a scale of 1-5 or 1-6, where a low number reflects a better outcome. A composite score for a patient is calculated by aggregating and averaging the scores from the 11 sub-scales (excluding general health sub-scale), and an algorithm is apply to give equal weight to each sub-scale. Sub-scales and composite scores are calculated by converting the response from questionnaires into a 0-100 scale, with 0 as the worst possible outcome and 100 as the best. Missing data was not imputed|12 month|ITT defined as all patients receiving at least one dose of either study treatment for monotherapy treatment arms, or one of the two study treatments for the combination therapy arm, and having at least 1 post-baseline assessment. Patients from one study site were excluded from ITT. Patients with both baseline and 12 month data were included||Units on a Scale||Standard Deviation|Mean
820213|NCT01135914|Secondary|Percentage of Patients Achieving Gain of Letters From Baseline in BCVA|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of BCVA (EDTRS) is 0 to 100 letters. A gain of 5,10,15 or more BCVA letters from baseline indicates improvement.|12 months|ITT defined as all patients receiving at least one dose of either study treatment for monotherapy treatment arms, or one of the two study treatments for the combination therapy arm, and having at least 1 post-baseline assessment. Patients from one study site were excluded from ITT. Patients with 12 month data were included||Percentage of Patients|||Number
820214|NCT01135914|Secondary|Percentage of Patients Achieving a Gain of 15-letters or More (3-lines) in BCVA From Baseline|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of BCVA (EDTRS) is 0 to 100 letters. A higher percent of patients achieving a gain of ≥15 letters BCVA indicates a better response.|Baseline, 3, 6, 9 and 12 months|The ITT population was defined as all patients receiving at least one dose of either study treatment for monotherapy treatment arms, or one of the two study treatments for the combination therapy arm, and having at least 1 post-baseline assessment. Patients from one site were excluded from ITT||Percentage of Patients|||Number
820215|NCT01135914|Secondary|Change From Baseline in Central Retinal Thickness (CRT) at Months 3,6,9 and 12|OCT is a diagnostic imaging technique using low-coherence interferometry to produce cross-sectional tomograms of the posterior segment eye structures. OCT was performed prior to study treatment to assess CRT, presence of fluid in the macula (intra-retinal cyst or fluid) and evaluation of image to monitor disease progression/treatment effect and to determine the need to stop/re-initiate ranibizumab treatment|Baseline, 3, 6, 9 and 12 months|The ITT population was defined as all patients receiving at least one dose of either study treatment for monotherapy treatment arms, or one of the two study treatments for the combination therapy arm, and having at least 1 post-baseline assessment. Patients from one site were excluded from ITT.||um||Standard Deviation|Mean
820216|NCT01135914|Secondary|Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Months 3,6 and 9|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of BCVA (EDTRS)is 0 to 100 letters. A positive change from baseline of BCVA indicates improvement.|Baseline, 3, 6 and 9 months|The ITT population was defined as all patients receiving at least one dose of either study treatment for monotherapy treatment arms, or one of the two study treatments for the combination therapy arm, and having at least 1 post-baseline assessment. Patients from one site were excluded from ITT.||Letters||Standard Deviation|Mean
820217|NCT01135914|Primary|Mean Change From Baseline in Best Corrected Visual Acuity- (BCVA) at Month 12|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of BCVA (EDTRS) is 0 to 100 letters. A positive change from baseline of BCVA indicates improvement.|Baseline and 12 months|ITT defined as all patients receiving at least one dose of either study treatment for monotherapy treatment arms, or one of the two study treatments for the combination therapy arm, and having at least 1 post-baseline assessment. Patients from one study site were excluded from ITT. patients with both baseline and 12 month data were included.||Letters||Standard Deviation|Mean
820218|NCT01141374|Secondary|Stress Levels(3rd and 4th Evaluation)|Scale Information: Stress Symptoms List (LSS) with 60 items Low score (better outcome): 12/29 points; Medium score: 30/60 points; High score: 61/120 points; Very high score (worse outcome): >120 points.|after 60 and 75 days|75 participants were assessed||units on a scale||Standard Deviation|Mean
820219|NCT01141374|Primary|Stress Levels After 4 Sessions (2nd Evaluation)|Scale information: Stress Symptoms List (LSS)with 60 items (better outcome)Low score: 12/29 points; Medium score: 30/60 points; High score: 61/120 points; Very high score (worse outcome): >120 points.|after 30 days|Of the 109 subjects, four were eliminated for having a low level of stress and 3 for not belonging to nursing staff. Of the 105, 7 didn't appear in the first session. Some lost sessions and were also excluded. One abandoned the treatment because of the side effects, one did not complete the questionnaire, seven went on vacation or sick leave (2).||units on a scale||Standard Deviation|Mean
820220|NCT01141491|Secondary|Overall Survival|To compare the overall survival over time, to estimate the median and 3-year progression-free survival.|Measured over time||04/2017||||
820221|NCT01141491|Primary|Progression Free Survival|"The primary objective is to compare the progression-free survival (PFS) over time.
Progression free survival is defined as the time from randomization until any evidence of tumor growth or appearance anywhere in the body or death from any cause as determined by the principal investigator at each site. The principal investigator will determine Progression-free survival by using CT scans to evaluate disease recurrence. For the purpose of this study, progression of disease is defined as the development of tumor growth or recurrence at any site of the body as determined by the principal investigator at each study site or death from disease"|3-years|||Days||95% Confidence Interval|Median
820229|NCT01141647|Secondary|Determine Cost-effectiveness.|QALYs are the mean quality adjusted life years per patient for the Supported Employment and Standard Care groups. The QALY is a non-negative number assessing the quality and length of life and not just the crude number of years. The minimum value is 0 representing no improvement in the quality of life or length of life and larger numbers indicate healthier and longer life. Maximum QALYs are limited only by the life span of study participants, but may not exceed 1 (perfect health) in any given year.|24-month phase with face-to-face quarterly interviews|213 SE participants in the PrOMOTE study were compared to 76 individuals in the control group of the SCI-VIP study.||years||Standard Deviation|Mean
820230|NCT01141647|Secondary|Determine Total Cost Per Patient Over 24 Months|Total cost is the mean total cost per patient over 24 months in US dollars. The minimum value is 0 representing no cost in US dollars and larger numbers indicating higher costs in US dollars.|24-month phase with face-to-face quarterly interviews|213 SE participants in the PrOMOTE study were compared to 76 individuals in the control group of the SCI-VIP study.||US dollars||Standard Deviation|Mean
820231|NCT01141647|Secondary|Evaluate the Effectiveness of Implementation Strategy and Level of SE Model Implementation Across Sites.|Level of implementation was assessed by interviewing clinical and vocational providers from the seven sites who were involved in or knowledgeable about the program. Values reported represent the numbers of clinical staff who cited having the VRS integrated on the clinical team, a full-time VRS, leadership support, engagement of staff, resources provided immediately, making adjustments to the implementation to fit with the local context, and having audit and feedback as supporting strong implementation|24-month phase with face-to-face quarterly interviews|Each stage comprised of two site visits. Please note that in the early stage fit of IPS model and audit and feedback were not assessed in either of the site visits, hence a value of zero is entered. Also note that in the late stage obtaining resources, fit of IPS model, and audit and feedback were only assessed at 1/2 of the site visits.||participants|||Number
820232|NCT01141647|Secondary|Determine Ongoing Effectiveness of SE Over Time.|This measure is used to evaluate the participants who were both in SCI-VIP and PrOMOTE. It assesses the number of people who obtained CE in SCI-VIP and sustained the same CE through their time in the PrOMOTE study. The cohort of SCI-VIP SE participants in PrOMOTE were analyzed separately from the 213 PrOMOTE participants.|48-month phase with face-to-face quarterly interviews|Number of participants in 24-month SE and 24-month SCI-VIP (previous study).||participants|||Number
820233|NCT01141647|Secondary|Employment Rate|Competitive Employment (CE) rate for individuals who participated in the Supported Employment arm of the PrOMOTE Study.|24 Months|||percentage of participants with CE|||Number
820234|NCT01141647|Primary|Identify Factors That Predict Employment After SCI.|To model the probability of obtaining CE, we first dichotomized CE as 'yes' or 'no'. The Competitive Employment Rate is reported in Outcome Measure 2. We then used unconditional logistic regression to model the probability of obtaining CE through a univariate modeling approach to determine statistically significant predictors of CE. Statistically significant predictors at the p<0.10 criterion level were then explored in a final multivariate model. Demographic (age, race, marital status, etc.), clinical (severity of injury, comorbidities, time since injury, etc.), barriers and facilitators, and quality of life (depression, Satisfaction with Life, etc.) were considered for modeling. A final model was obtained by including all parameters meeting the p<0.10 criterion into a final multivariate model.|24-month phase with face-to-face quarterly interviews|||Odds Ratio||90% Confidence Interval|Number
820235|NCT01142193|Secondary|Proportion of Subjects ≥50% Reduction (Responder Rate) in Weekly (7 Day) Partial-onset Seizure Frequency During the Maintenance Phase Compared to Baseline.||8 weeks (weeks 4-11)|Intent-to-treat (ITT): all subjects who were randomized and received at least 1 dose of study drug. Note: Sample size is less than for primary outcome because some subjects discontinued study prior to the maintenance phase.||Percentage of participants|||Number
820236|NCT01142193|Secondary|Percent Reduction From Baseline in Weekly (7 Day) Partial-onset Seizure Frequency During the Maintenance Phase Compared to Baseline.||8 weeks (weeks 4-11)|Intent-to-treat (ITT): all subjects who were randomized and received at least 1 dose of study drug. Note: Sample size is less than for primary outcome because some subjects discontinued study prior to the maintenance phase.||Percent Reduction||Full Range|Median
820237|NCT01142193|Secondary|Proportion of Subjects With ≥25%, ≥75%, and 100% Reduction in Weekly (7 Day) Partial-onset Seizure Frequency During the Maintenance Phase Compared to Baseline.||8 weeks (weeks 4-11)|Intent-to-treat (ITT): all subjects who were randomized and received at least 1 dose of study drug. Note: Sample size is less than for primary outcome because some subjects discontinued study prior to the maintenance phase.||Percentage of participants|||Number
820238|NCT01142193|Secondary|Proportion of Subjects With ≥25%, ≥75%, and 100% Reduction in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Plus Maintenance Phase Compared to Baseline.||11 weeks|Intent-to-treat (ITT): all subjects who were randomized and received at least 1 dose of study drug||Percentage of participants|||Number
820239|NCT01142193|Secondary|Proportion of Subjects With ≥25%, ≥75%, and 100% Reduction in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Phases Compared to Baseline.||3 weeks (weeks 1-3)|Intent-to-treat (ITT): all subjects who were randomized and received at least 1 dose of study drug||Percentage of participants|||Number
820240|NCT01142193|Secondary|Percent Reduction From Baseline in Weekly (7 Day) All Seizure Frequency During the Titration Plus Maintenance Phase.||11 weeks|Intent-to-treat (ITT): all subjects who were randomized and received at least 1 dose of study drug||Percent Reduction||Full Range|Median
820241|NCT01142193|Secondary|Percent Reductions From Baseline in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Phase Compared to Baseline.||3 weeks (weeks 1-3)|Intent-to-treat (ITT): all subjects who were randomized and received at least 1 dose of study drug||Percent Reduction||Full Range|Median
820242|NCT01142193|Secondary|Proportion of Subjects With ≥50% Reduction (Responder Rate) in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Phase Compared to Baseline.||3 weeks (weeks 1-3)|||Percentage of participants|||Number
820243|NCT01142193|Secondary|Proportion of Subjects With ≥50% Reduction (Responder Rate) in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Plus Maintenance Phase Compared to Baseline.||11 weeks|Intent-to-treat (ITT): all subjects who were randomized and received at least 1 dose of study drug||Percentage of participants|||Number
820252|NCT01142336|Primary|Change From Baseline in CSF Total Tau at 1 Year|CSF total tau was measured at baseline and after 1-year of intervention|1-yr change|"In the Placebo group, 1 participant was dropped due to AE and 1 was lost to follow-up.
In the Simvastatin group, 1 participant was dropped due to AE. These 3 participants were not included in the primary analysis per analysis plan.
All these 3 subjects were not included in the primary analysis based on our per protocol analysis plan."||pg/ml||Standard Deviation|Mean
820253|NCT01142336|Primary|Change From Baseline in Aβ42 in Cerebrospinal Fluid (CSF) at 1 Year|CSF Aβ42 concentration were measured at baseline and after 1-year intervention.|1-year change of CSF Aβ42 from baseline|"In the Placebo group, 1 participant was dropped due to AE and 1 was lost to follow-up.
In the Simvastatin group, 1 participant was dropped due to AE. These 3 participants were not included in the primary analysis per analysis plan.
All these 3 subjects were not included in the primary analysis based on our per protocol analysis plan."||1-yr change, pg/ml||Standard Deviation|Mean
820254|NCT01142388|Secondary|Objective Response Rate|Objective response rate is defined as number of patients with complete response (CR) or partial response (PR) divided by all eligible patients. Responses are evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline. CR is defined as disappearance of all target and non-target lesions and normalization of tumor marker level. PR is defined as disappearance of target lesions or at least a 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameters), and persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits.|assessed every 8 weeks while on treatment and every 3 months after treatment for 2 years|Eligible patients||percentage of participants||90% Confidence Interval|Number
820255|NCT01142388|Secondary|Overall Survival|Overall survival (OS) is defined as the time from randomization until death (event), or censored at last date known alive. OS was estimated using the Kaplan-Meier method, with 90% confidence intervals calculated using Greenwood’s formula, and compared by the log rank test.|assessed every 3 months for 2 years after registration|Eligible patients||months||90% Confidence Interval|Median
820256|NCT01142388|Primary|Progression-free Survival|Progression-free survival (PFS) is defined as the time from randomization to progression or death without evidence of progression. For cases without documentation of progression, follow-up was censored at the date of last disease assessment without progression, unless death occurred within a short period of time (4 months) following the date last known progression-free, in which case the death was counted as an event, or in the case of death within 4 months of randomization in the absence of disease evaluation before that time. PFS was estimated using the Kaplan-Meier method, with 90% confidence intervals calculated using Greenwood’s formula, and compared by the log rank test.|assessed every 3 months for 2 years after registration|Eligible patients.||months||90% Confidence Interval|Median
820257|NCT01142466|Secondary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition.|Baseline to Week 96|Safety population included all participants all randomized participants of the active treatment group who received at least 1 injection and all randomized participants of the ‘No Treatment’ group, provided that any post-baseline data was available.||participants|||Number
820258|NCT01142466|Secondary|Mean Changes in Expanded Disability Status Scale (EDSS) Score From Baseline to Week 12, 24, 36, 48, 60, 72, 84, and 96|EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. EDSS progression was defined as increase by at least 1 point if last value of EDSS was equal to 5.5, and by at least 0.5 points if last EDSS was more than 5.5.|Baseline to Week 12, 24, 36, 48, 60, 72, 84, and 96|ITT population included all participants who received at least 1 treatment dose (only for Rebif group) and had at least 1 post-baseline efficacy endpoint assessment. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively.||Units on a Scale||Standard Deviation|Mean
820259|NCT01142466|Secondary|Absolute Changes in the Number of T2 Lesions From Baseline to Week 24, 48, 72 and 96|Analysis of T2 lesions was done using magnetic resonance imaging (MRI) scans.|Baseline to Week 24, 48, 72, and 96|ITT population included all participants who received at least 1 treatment dose (only for Rebif group) and had at least 1 post-baseline efficacy endpoint assessment. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively.||T2 lesions||Standard Deviation|Mean
820260|NCT01142466|Secondary|Absolute Changes in the Number of T1-Gadolinium (T1-Gd) Lesions From Baseline to Week 24, 48, 72 and 96|Analysis of T1-Gadolinium enhancing lesions was done using magnetic resonance imaging (MRI) scans.|Baseline to Week 24, 48, 72, and 96|The data was not evaluated due to the small sample size available for this parameter.|||||
820261|NCT01142466|Secondary|Absolute Changes in the Number of T1 Lesions From Baseline to Week 24, 48, 72 and 96|Analysis of T1 lesions was done using magnetic resonance imaging (MRI) scans.|Baseline to Week 24, 48, 72, and 96|ITT population included all participants who received at least 1 treatment dose (only for Rebif group) and had at least 1 post-baseline efficacy endpoint assessment. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively.||T1 lesions||Standard Deviation|Mean
820262|NCT01142466|Secondary|Number of Relapse-free Participants|A qualifying relapse was defined as a new or worsening neurological symptom, in the absence of fever, lasting for >= 48 hours, and accompanied by an objective change in the relevant (i.e. symptomatic) Kurtzke Functional Systems (KFS).|Baseline through Week 96|ITT population included all participants who received at least 1 treatment dose (only for Rebif group) and had at least 1 post-baseline efficacy endpoint assessment.||participants|||Number
820263|NCT01142466|Primary|Time From Baseline to First Multiple Sclerosis Relapse (in Weeks)|A qualifying relapse was defined as a new or worsening neurological symptom, in the absence of fever, lasting for >= 48 hours, and accompanied by an objective change in the relevant (i.e. symptomatic) Kurtzke Functional Systems (KFS).|Baseline through Week 96|Intent-to-treat (ITT) population included all participants who received at least 1 treatment dose (only for Rebif group) and had at least 1 post-baseline efficacy endpoint assessment. Time to relapse was documented for participants who had at least 1 relapse during the study period.||weeks||Standard Deviation|Mean
820264|NCT01142596|Primary|Median Time to Loss of Effect in Non-Responders|Median time to loss of effect from P06125 extension study baseline was estimated using Kaplan-Meier product-limit method. Result reported in Non-Responders, participants without ≥30% decrease from study P06124 baseline in PANSS Total Score at the end of study P06124. Investigator or subinvestigator was to determine whether the study drug failed to maintain effect based on occurrence of any of the following: 1) Increase in PANSS Total Score ≥30% from P06125 extension study baseline, 2) Determination that participant’s schizophrenic symptomatology had deteriorated requiring one or more of defined interventions (add new antipsychotic drug, increase in level of psychiatric outpatient care, or hospitalization/increase in level of hospitalization for psychiatric need), 3) Clinical Global Impression-Severity (CGI-S) score ≥6, 4) Discontinuation from study because of lack of efficacy, 5) AE/SAE of worsening of schizophrenia.|P06124 study baseline and Day 42, and P06125 study from Day 1 up to Week 52|All participants randomized in study P06125 who received at least one dose of study drug, had PANSS measurement at P06125 baseline and at least one post-baseline PANSS measurement, and were study P06124 Non-Responders||days||95% Confidence Interval|Median
820265|NCT01142596|Primary|Median Time to Loss of Effect in Responders|Median time to loss of effect from P06125 extension study baseline was estimated using Kaplan-Meier product-limit method. Result reported in Responders, participants with ≥30% decrease from study P06124 baseline in Positive and Negative Syndrome Scale (PANSS, schizophrenia symptom scale) Total Score at the end of study P06124. Investigator or subinvestigator was to determine whether the study drug failed to maintain effect based on occurrence of any of the following: 1) Increase in PANSS Total Score ≥30% from P06125 extension study baseline, 2) Determination that participant’s schizophrenic symptomatology had deteriorated requiring one or more of defined interventions (add new antipsychotic drug, increase in level of psychiatric outpatient care, or hospitalization/increase in level of hospitalization for psychiatric need), 3) Clinical Global Impression-Severity (CGI-S) score ≥6, 4) Discontinuation from study because of lack of efficacy, 5) AE/SAE of worsening of schizophrenia.|P06124 study baseline and Day 42, and P06125 study from Day 1 up to Week 52|All participants randomized in study P06125 who received at least one dose of study drug, had PANSS measurement at P06125 baseline and at least one post-baseline PANSS measurement, and were study P06124 Responders||days||95% Confidence Interval|Median
820266|NCT01142596|Primary|Number of Participants Who Took Antiparkinsonian Drugs|This measure presents the number of participants who used antiparkinsonian drugs started on or after the start of study treatment in extension study P06125. Antiparkinsonian drugs were defined as those categorized into the N04 code (antiparkinson drugs) of the World Health Organization (WHO) Anatomical Therapeutic Chemical (ATC) classification system.|P06125 study from Day 1 up to Week 52|All participants randomized in study P06125 who received at least one dose of study drug||participants|||Number
820267|NCT01142596|Primary|Percentage of Participants With Abnormalities on Electrocardiogram (ECG) at Study P06124 Baseline, Study P06125 Baseline and Week 52|The percentage of participants with abnormal ECG findings is reported for three time points: 6-week double-blind study P06124 baseline, extension study P06125 baseline and extension study Week 52.|Study P06124 baseline and P06125 study baseline and Week 52|All participants randomized in study P06125 who received at least one dose of study drug||percentage of participants|||Number
820268|NCT01142596|Primary|Number of Participants With Non-serious AEs|An AE is defined as any untoward medical occurrence in a participant administered study drug and which does not necessarily have to have a causal relationship with the study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with study drug administration, whether or not considered related to study drug. This measure presents the number of participants with at least one AEs that was non-serious (i.e., was not determined to be an SAE).|Up to 30 days after last dose of study drug (Up to approximately 56 weeks)|All participants randomized in study P06125 who received at least one dose of study drug||participants|||Number
820269|NCT01142596|Primary|Number of Participants With Serious Adverse Events (AEs)|An AE is defined as any untoward medical occurrence in a participant administered study drug and which does not necessarily have to have a causal relationship with the study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with study drug administration, whether or not considered related to study drug. A serious AE (SAE) is any AE occurring at any dose that results in death, is life-threatening, results in hospitalization or prolongation of hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. In addition, an important medical event that may not result in death, be life-threatening, or require hospitalization may be considered an SAE when it may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.|Up to 30 days after last dose of study drug (Up to approximately 56 weeks)|All participants randomized in study P06125 who received at least one dose of study drug||participants|||Number
820270|NCT01142596|Primary|Change From Study P06125 Baseline in Prolactin at Week 52|For each participant, change in prolactin from extension study P06125 baseline to Week 52 of extension study was determined (calculated as Week 52 value minus baseline value).|Study P06125 baseline and Week 52|All participants randomized in study P06125 who received at least one dose of study drug, and had data for measure at study P06125 baseline and Week 52||μg/L||Standard Deviation|Mean
820271|NCT01142596|Primary|Change From Study P06124 Baseline in Prolactin at Week 52|For each participant, change in prolactin from preceding 6-week double-blind Study P06124 baseline to Week 52 of extension study P06125 was determined (calculated as Week 52 value minus baseline value).|Study P06124 baseline and study P06125 Week 52|All participants randomized in study P06125 who received at least one dose of study drug, and had data for measure at study P06124 baseline and study P06125 Week 52||μg/L||Standard Deviation|Mean
820272|NCT01142596|Primary|Change From Study P06125 Baseline in Insulin at Week 52|For each participant, change in insulin from extension study P06125 baseline to Week 52 of extension study was determined (calculated as Week 52 value minus baseline value).|Study P06125 baseline and Week 52|All participants randomized in study P06125 who received at least one dose of study drug, and had data for measure at study P06125 baseline and Week 52||μIU/mL||Standard Deviation|Mean
820478|NCT01144299|Primary|Number of Seroprotected Subjects|A seroprotected subject is a subject with a serum HI antibody titer ≥ 1:40|Day 0 and Day 21|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available data||subjects|||Number
820273|NCT01142596|Primary|Change From Study P06124 Baseline in Insulin at Week 52|For each participant, change in insulin from preceding 6-week double-blind Study P06124 baseline to Week 52 of extension study P06125 was determined (calculated as Week 52 value minus baseline value).|Study P06124 baseline and study P06125 Week 52|All participants randomized in study P06125 who received at least one dose of study drug, and had data for measure at study P06124 baseline and study P06125 Week 52||μIU/mL||Standard Deviation|Mean
820274|NCT01142596|Primary|Change From Study P06125 Baseline in Fasting Glucose at Week 52|For each participant, change in fasting glucose from extension study P06125 baseline to Week 52 of extension study was determined (calculated as Week 52 value minus baseline value).|Study P06125 baseline and Week 52|All participants randomized in study P06125 who received at least one dose of study drug, and had data for measure at study P06125 baseline and Week 52||mmol/L||Standard Deviation|Mean
820275|NCT01142596|Primary|Change From Study P06124 Baseline in Fasting Glucose at Week 52|For each participant, change in fasting glucose from preceding 6-week double-blind Study P06124 baseline to Week 52 of extension study P06125 was determined (calculated as Week 52 value minus baseline value).|Study P06124 baseline and study P06125 Week 52|All participants randomized in study P06125 who received at least one dose of study drug, and had data for measure at study P06124 baseline and study P06125 Week 52||mmol/L||Standard Deviation|Mean
820276|NCT01142596|Primary|Change From Study P06125 Baseline in HbA1c at Week 52|For each participant, change in HbA1c from extension study P06125 baseline to Week 52 of extension study was determined (calculated as Week 52 value minus baseline value).|Study P06125 baseline and Week 52|All participants randomized in study P06125 who received at least one dose of study drug, and had data for measure at study P06125 baseline and Week 52||percentage of HbA1c||Standard Deviation|Mean
820277|NCT01142596|Primary|Change From Study P06124 Baseline in Glycosylated Hemoglobin (HbA1c) at Week 52|For each participant, change in HbA1c from preceding 6-week double-blind Study P06124 baseline to Week 52 of extension study P06125 was determined (calculated as Week 52 value minus baseline value).|Study P06124 baseline and study P06125 Week 52|All participants randomized in study P06125 who received at least one dose of study drug, and had data for measure at study P06124 baseline and study P06125 Week 52||percentage of HbA1c||Standard Deviation|Mean
820278|NCT01142596|Primary|Change From Study P06125 Baseline in DIEPSS Item 9 Score at Endpoint|Change in DIEPSS Item 9 (Global) Score from extension study P06125 baseline to the endpoint assessment of extension study was determined (calculated as endpoint value minus baseline value). Endpoint assessment was last evaluation of participant for this measure in study, whether participant completed or did not complete study. DIEPSS is a scale, rated by the investigator or rater appointed by the investigator, used to evaluate the severity of drug induced extrapyramidal symptoms occurring during antipsychotic drug treatment. It consists of 9 items: Items 1 through 8 assess individual symptoms; Item 9 is an assessment of global severity. Each item is rated from 0 (none, normal) to 4 (severe). Negative values of change from baseline represent improvement in symptoms.|Study P06125 baseline up to Week 52|All participants randomized in study P06125 who received at least one dose of study drug, and had data for measure at study P06125 baseline and endpoint assessment||score on a scale||Standard Deviation|Mean
820279|NCT01142596|Primary|Change From Study P06124 Baseline in DIEPSS Item 9 Score at Endpoint|Change in DIEPSS Item 9 (Global) Score from preceding 6-week double-blind Study P06124 baseline to endpoint assessment of extension study P06125 was determined (calculated as endpoint value minus baseline value). Endpoint assessment was last evaluation of participant for this measure in study, whether participant completed or did not complete study. DIEPSS is a scale, rated by the investigator or rater appointed by the investigator, used to evaluate the severity of drug induced extrapyramidal symptoms occurring during antipsychotic drug treatment. It consists of 9 items: Items 1 through 8 assess individual symptoms; Item 9 is an assessment of global severity. Each item is rated from 0 (none, normal) to 4 (severe). Negative values of change from baseline represent improvement in symptoms.|Study P06124 baseline and P06125 study from Day 1 up to Week 52|All participants randomized in study P06125 who received at least one dose of study drug, and had data for measure at study P06124 baseline and study P06125 endpoint assessment||score on a scale||Standard Deviation|Mean
820280|NCT01142596|Primary|Change From Study P06125 Baseline in DIEPSS Total Score at Endpoint|Change in DIEPSS Total Score from extension study P06125 baseline to the endpoint assessment of extension study was determined (calculated as endpoint value minus baseline value). Endpoint assessment was last evaluation of participant for this measure in study, whether participant completed or did not complete study. DIEPSS is a scale, rated by the investigator or rater appointed by the investigator, used to evaluate the severity of drug induced extrapyramidal symptoms occurring during antipsychotic drug treatment. It consists of 9 items: Items 1 through 8 assess individual symptoms; Item 9 is an assessment of global severity. Items 1 through 8 are classified into 4 categories of parkinsonism, akathisia, dystonia and dyskinesia. Each item is rated from 0 (none, normal) to 4 (severe). The Total Score is the sum of scores on Items 1 through 8, with a range from 0 (normal) to 32 (severe). Negative values of change from baseline represent improvement in symptoms.|Study P06125 baseline up to Week 52|All participants randomized in study P06125 who received at least one dose of study drug, and had data for measure at study P06125 baseline and endpoint assessment||score on a scale||Standard Deviation|Mean
820281|NCT01142596|Primary|Change From Study P06124 Baseline in Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Total Score at Endpoint|Change in DIEPSS Total Score from preceding 6-week double-blind Study P06124 baseline to endpoint assessment of extension study P06125 was determined (calculated as endpoint value minus baseline value). Endpoint assessment was last evaluation of participant for this measure in study, whether participant completed or did not complete study. DIEPSS is a scale, rated by the investigator or rater appointed by the investigator, used to evaluate the severity of drug induced extrapyramidal symptoms occurring during antipsychotic drug treatment. It consists of 9 items: Items 1 through 8 assess individual symptoms; Item 9 is an assessment of global severity. Items 1 through 8 are classified into 4 categories of parkinsonism, akathisia, dystonia and dyskinesia. Each item is rated from 0 (none, normal) to 4 (severe). The Total Score is the sum of scores on Items 1 through 8, with a range from 0 (normal) to 32 (severe). Negative values of change from baseline represent improvement in symptoms.|Study P06124 baseline and P06125 study from Day 1 up to Week 52|All participants randomized in study P06125 who received at least one dose of study drug, and had data for measure at study P06124 baseline and study P06125 endpoint assessment||score on a scale||Standard Deviation|Mean
820282|NCT01142596|Primary|Number of Participants With Extrapyramidal Symptoms|This measure reports the overall number of participants with any of a group of adverse events that were defined to represent extrapyramidal symptoms. The number of participants with each of the individual adverse events within this definition is also presented, for terms that occurred in at least one participant. For this measure, all adverse event terms within the Medical Dictionary for Regulatory Activities (MedDRA) Standardized MedDRA Query (SMQ) for “extrapyramidal syndrome” were treated as extrapyramidal symptoms.|Up to 30 days after last dose of study drug (Up to approximately 56 weeks)|All participants randomized in study P06125 who received at least one dose of study drug||participants|||Number
820283|NCT01142596|Primary|Change From Study P06125 Baseline in BMI at Week 52|For each participant, change in BMI from extension study P06125 baseline to Week 52 of extension study was determined (calculated as Week 52 value minus baseline value).|Study P06125 baseline and Week 52|All participants randomized in study P06125 who received at least one dose of study drug, and had data for measure at study P06125 baseline and Week 52||kg/m^2||Standard Deviation|Mean
820284|NCT01142596|Primary|Change From Study P06124 Baseline in Body Mass Index (BMI) at Week 52|For each participant, change in BMI from preceding 6-week double-blind Study P06124 baseline to Week 52 of extension study P06125 was determined (calculated as Week 52 value minus baseline value).|Study P06124 baseline and study P06125 Week 52|All participants randomized in study P06125 who received at least one dose of study drug, and had data for measure at study P06124 baseline and study P06125 Week 52||kg/m^2||Standard Deviation|Mean
820285|NCT01142596|Primary|Percentage of Participants in Categories of Change in Weight From Study P06125 Baseline to Final Assessment|For each participant, change in weight from extension study P06125 baseline to the final assessment of extension study was determined (calculated as final assessment value minus baseline value). Final assessment was last evaluation of participant in study, whether participant completed or did not complete study. Participants were allocated to categories of percentage change from defined baseline to final assessment.|Study P06125 baseline up to Week 52|All participants randomized in study P06125 who received at least one dose of study drug, and had data for measure at study P06125 baseline and final assessment||percentage of participants in category|||Number
820286|NCT01142596|Primary|Percentage of Participants in Categories of Change in Weight From Study P06124 Baseline to Final Assessment|For each participant, change in weight from preceding 6-week double-blind Study P06124 baseline to the final assessment of extension study P06125 was determined (calculated as final assessment value minus baseline value). Final assessment was last evaluation of participant in study, whether participant completed or did not complete study. Participants were allocated to categories of percentage change from defined baseline to final assessment.|Study P06124 baseline and P06125 study from Day 1 up to Week 52|All participants randomized in study P06125 who received at least one dose of study drug, and had data for measure at study P06124 baseline and study P06125 final assessment||percentage of participants in category|||Number
820287|NCT01142661|Primary|Safety|General safety will be assessed by monitoring and recording the number of patients with serious adverse events for duration of treatment which continued until disease progression, unacceptable toxicity or death.|For duration of treatment, an average of 5 months|||participants|||Number
820288|NCT01142661|Primary|Safety|General safety will be assessed by monitoring and recording the number of patients with adverse events (serious and nonserious) for duration of treatment which continued until disease progression, unacceptable toxicity or death.|For duration of treatment, an average of 5 months|||participants|||Number
820289|NCT01142726|Secondary|Number of Participants With Results on Hematology and Clinical Laboratory Tests Meeting the Criteria for Marked Abnormality in Re-exposure Period|LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Criteria for marked abnormality on laboratory test results: Platelet count (*10^9 c/µL) <0.67*LLN or >1.5*ULN, or if preRX<LLN, use 0.5*preRX and <100,000/mm^3; potassium, serum (mEq) <0.9*LLN or >1.1*ULN, or if preRX <LLN, use <0.9*preRX or >ULN if preRX>ULN, use >1.1*preRX or <LLN; blood urea nitrogen (mg/dL) >2*preRX; creatinine (mg/dL) >1.5*preRX; ALT (U/L) >3*ULN, or if preRX>ULN, use >4*preRX; AST (U/L) >3*ULN, or if preRX>ULN, use >4*preRX; ALP (U/L) >2*ULN, or if preRX>ULN, use >3*preRX; G-glutamyl transferase U/L) >2*ULN, or if preRX>ULN, use >3*preRX; glucose, fasting (mg/dL) <0.8*LLN or >1.5*ULN, or if preRX<LLN use <0.8*preRX or >ULN if preRX >ULN, use >2.0*preRX or OR <LLN; glucose, serum (mg/dL) <65 or >220; uric acid (mg/dL)>1.5*ULN, or if preRX, use >2*preRX; albumin (g/dL) <0.9*LLN, or if preRX<LLN, use <0.75*preRX; hemoglobin (g/dL)>3 decrease from preRX; hematocrit (%) < 0.75*preRX.|Start of re-exposure period to 56 days post last dose, up to Month 30|All treated participants entering the Re-exposure Period and having measurements available were analyzed. n=evaluable. Treatment groups represent Treatment received during Treatment Period.||participants|||Number
820290|NCT01142726|Secondary|Number of Participants With Results on Hematology and Clinical Laboratory Tests Meeting the Criteria for Marked Abnormality in Withdrawal Period|LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Criteria for marked abnormality on laboratory test results: Platelet count (*10^9 c/µL) <0.67*LLN or >1.5*ULN, or if preRX<LLN, use 0.5*preRX and <100,000/mm^3; potassium, serum (mEq) <0.9*LLN or >1.1*ULN, or if preRX <LLN, use <0.9*preRX or >ULN if preRX>ULN, use >1.1*preRX or <LLN; blood urea nitrogen (mg/dL) >2*preRX; creatinine (mg/dL) >1.5*preRX; ALT (U/L) >3*ULN, or if preRX>ULN, use >4*preRX; AST (U/L) >3*ULN, or if preRX>ULN, use >4*preRX; ALP (U/L) >2*ULN, or if preRX>ULN, use >3*preRX; G-glutamyl transferase (GGT) (U/L) >2*ULN, or if preRX>ULN, use >3*preRX; glucose, fasting (mg/dL) <0.8*LLN or >1.5*ULN, or if preRX<LLN use <0.8*preRX or >ULN if preRX >ULN, use >2.0*preRX or OR <LLN; glucose, serum (mg/dL) <65 or >220; uric acid (mg/dL)>1.5*ULN, or if preRX, use >2*preRX; albumin (g/dL) <0.9*LLN, or if preRX<LLN, use <0.75*preRX; hemoglobin (g/dL)>3 decrease from preRX; hematocrit (%) < 0.75*preRX.|Last dose in TP + 57 days, up to Month 24|All randomized participants who received at least 1 dose of study drug in the Treatment Period, entered the Withdrawal Period, and had values available. n=number evaluable||participants|||Number
820312|NCT01142908|Secondary|Body Mass Index|Calculated from vitals (height & weight) obtained during interview|12 months|39 out of the 215 participants in the Pharmacist CVD group and 31 out of the 213 in the Education Control group had missing body mass index at 12 months due to missing the 12 month interview entirely or the interview was completed over the phone, or weight was not obtained at the 12 month interview.||kg/m^2||Standard Deviation|Mean
820719|NCT01147497|Primary|Provider Perceived Ease of Insertion on a 100 Point Visual Analogue Scale|The visual analogue scale for perceived ease ranges from 0 (most ease) to 100 (most difficult).|assessed immediately post IUD insertion|||units on a scale||Full Range|Median
820291|NCT01142726|Secondary|Adverse Events (AEs) of Interest During the Re-exposure Period|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. AEs of special interest are events potentially associated with the drug or disease under study. Includes data up to 56 days post the last dosing day (active abatacept or active MTX, whichever is the later) in the Re-exposure Period. Treatment groups represent Treatment received during Treatment Period.|First dose in Re-exposure period up to last dose of Re-exposure Period + 56 days|Includes data up to 56 days post the last dosing day (active abatacept or active MTX, whichever is the later) in the Re-exposure Period. Treatment groups represent Treatment received during Treatment Period.||participants|||Number
820292|NCT01142726|Secondary|Adverse Events (AEs) of Interest During the Withdrawal Period|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. AEs of special interest are events potentially associated with the drug or disease under study. Includes events with an onset date on or after 57 days post last dosing day (active abatacept or active MTX whichever is the later) in the Treatment Period and up to end of Withdrawal Period. Treatment groups represent treatment received during the Treatment Period.|Last dose in TP + 57 days, up to Month 24|All randomized participants who received at least 1 dose of double-blind study medication in the Treatment Period and entered the Withdrawal Period. Treatment groups represent treatment during the TP.||participants|||Number
820293|NCT01142726|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs) and Discontinuations Due to AEs During the Full Study (All Periods)|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Includes data up to last active dose date +56 days if the participant discontinued the Treatment Period or did not enter the Withdrawal Period, up to the day of discontinuation in the Withdrawal Period for participants discontinuing the Withdrawal Period without entering the Re-exposure Period (RP), up to Day 729 visit (Month 24) for participants who complete the Withdrawal Period, and up to 56 days post last active dose in Re-exposure Period for participants entering the Re-exposure Period.|Day 1 to 56 days post last dose in the study, up to Month 30|All randomized participants who received at least 1 dose of study medication were analyzed.||participants|||Number
820294|NCT01142726|Secondary|Percentage of Participants Who Achieved Remission by Criteria of the Simplified Disease Activity Index (SDAI) Over Time in Treatment Period and Withdrawal Period|TP=treatment period; WP=withdrawal period. SDAI-defined remission= ≤3.3. The SDAI is the simple linear sum of 5 outcome parameters: tender joint count (TJC) and swollen joint count (SJC) (based on a 28-joint assessment); patient's and physician's global assessments of disease activity (assessed on 0-10 cm visual analog scale, on which higher scores=greater affection due to disease activity); and C-reactive protein level (mg/dL). SDAI total score=0-86. SDAI <=3.3 indicates disease remission, >3.4 to 11=low disease activity, >11 to 26=moderate disease activity, and >26=high disease activity. TJC is assessed and recorded at each visit, with no swelling=0, swelling=1. SJC is assessed through identification of joints that are painful under pressure or to passive motion. TJC is recorded on the joint assessment form at each visit, with no tenderness =0, tenderness = 1. Higher score indicates greater affection due to disease activity. Percent=number with remission/number evaluated (ITT)|Randomization to Month 24|ITT analysis population: Included all randomized participants who received at least 1 dose of double-blind study medication in the Treatment Period. Participants were grouped according to the treatment regimen to which they were randomized.N= number evaluated.||percentage of participants||95% Confidence Interval|Number
820295|NCT01142726|Secondary|Percentage of Participants With Remission by Disease Activity Score 28 Based on C-reactive Protein (DAS28-CRP) Criteria Over Time During Withdrawal Period- Treated Participants in Remission at Month 12|WP=withdrawal period. Remission defined as DAS28-CRP<2.6. The DAS 28-CRP is a measure of disease activity in rheumatoid arthritis (RA) and assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), CRP level (a measure of inflammation in the blood), and the patient's global assessment of health (ranging from very good to very bad). DAS-CRP scores range from 0 to 10, with higher values indicating greater disease activity. Individual measures are fed into a complex mathematical formula to produce the overall DAS (a score greater than 5.1 implies active disease; less than 3.2, well controlled disease; and less than 2.6, remission.). Percentage= number of participants with remission divided by number of participants who were analyzed (all treated participants who were in remission at end of treatment period and entered the Withdrawal Period)|End of Treatment Period (Month 12) to End of Withdrawal Period (Month 24)|Treated participants who were in remission at Month 12 (DAS28-CRP<2.6) and entered the Withdrawal Period were analyzed.( N=number of participants analyzed).||percentage of participants||95% Confidence Interval|Number
820296|NCT01142726|Secondary|Number of Participants With Results on Hematology and Clinical Laboratory Tests Meeting the Criteria for Marked Abnormality During Treatment Period|Lower limit of normal (LLN); Upper limit of normal (ULN); Pretreatment (preRX). Criteria for marked abnormality: Platelet count (*10^9 c/µL) <0.67*LLN or >1.5*ULN, or if preRX<LLN, use 0.5*preRX and <100,000/mm^3; potassium, serum (mEq) <0.9*LLN or >1.1*ULN, or if preRX <LLN, use <0.9*preRX or >ULN if preRX>ULN, use >1.1*preRX or <LLN; blood urea nitrogen (mg/dL) >2*preRX; creatinine (mg/dL) >1.5*preRX; ALT (U/L) >3*ULN, or if preRX>ULN, use >4*preRX; AST (U/L) >3*ULN, or if preRX>ULN, use >4*preRX; ALP (U/L) >2*ULN, or if preRX>ULN, use >3*preRX; G-glutamyl transferase U/L) >2*ULN, or if preRX>ULN, use >3*preRX; glucose, fasting (mg/dL) <0.8*LLN or >1.5*ULN, or if preRX<LLN use <0.8*preRX or >ULN if preRX >ULN, use >2.0*preRX or OR <LLN; glucose, serum (mg/dL) <65 or >220; uric acid (mg/dL)>1.5*ULN, or if preRX, use >2*preRX; albumin (g/dL) <0.9*LLN, or if preRX<LLN, use <0.75*preRX; hemoglobin (g/dL)>3 decrease from preRX; hematocrit (%) < 0.75*preRX.|Day 1 up to 56 days following the last dosing day in the Treatment Period (Day 365)|All randomized participants who received at least 1 dose of double-blind study medication in the Treatment Period. n=number evaluable||Participants|||Number
820720|NCT01141660|Secondary|Anesthetic and Recovery Times||2 years||||||
820297|NCT01142726|Secondary|Adverse Events (AEs) of Interest During the Treatment Period|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or unknown relationship to study drug. AEs of special interest are events potentially associated with the drug or disease under study.|Day 1 to 56 days following last dosing day (Day 365)|All randomized participants who received at least 1 dose of double-blind study medication in the Treatment Period||Participants|||Number
820298|NCT01142726|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Related SAEs, Discontinuations Due to SAEs, Related Adverse Events (AEs), and Discontinuations Due to AEs During the Treatment Period|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or unknown relationship to study drug.|Day 1 to up to 56 days following the last dosing day (Day 365); all deaths during study period, including those that occurred >56 days after last dose in Treatment Period|All randomized participants who received at least 1 dose of double-blind study medication in the Treatment Period||Participants|||Number
820299|NCT01142726|Secondary|Adjusted Mean Change From Baseline Over Time in Findings on Magnetic Resonance Imaging (MRI)|TP=treatment period; WP=withdrawal period. Change from Baseline=Postbaseline-baseline value. MRI was used to assess joint damage progression at Months 6, 12, and 18. If >20% of joints with a missing score for a parameter (erosion, osteitis, and synovitis), the MRI score of each parameter was considered missing. If ≤20% of joints had a missing score for a parameter, the MRI score for that parameter from the missing joints was carried forward from the previous MRI assessment, or carried backward from the next MRI assessment, if missing score occurred at baseline. MRI total score ranged from 0 (best outcome) to 4 (worst outcome). A gadolinium-enhanced MRI of the dominant hand-wrist was performed on all randomized patients at 5 points. The hand/wrist assessed to have more synovitis was selected initially and used for all subsequent evaluations. The MRI examination was standardized to ensure sufficient image quality for the evaluation of radiographic progression of rheumatoid arthritis.|Randomization to Month 18|All randomized participants who received at least 1 dose of double-blind study medication in the Treatment Period. n=the number of patients with both baseline and postbaseline measurements.||Units on a scale||Standard Error|Mean
820300|NCT01142726|Secondary|Adjusted Mean Change From Baseline at Months 6, 12, and 18 in Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores of Short Form-36 (SF-36)|TP=treatment period; WP=withdrawal period. The SF-36 is a 36-item self-administered questionnaire developed to assess health-related quality of life (QOL) and comprises 8 domains, including 4 physical (physical health, bodily pain, physical functioning and physical role limitations) and 4 mental (mental health, vitality, social functioning, and emotional role limitation) subscales. Responses are used to derive physical and mental component summary scores, ranging from 0 to 100, with higher scores indicating better QOL (0=Poorest Health; 100=Best Health). Mean change from baseline=postbaseline value-baseline value; a higher value signifies improvement.|Randomization to Months 6, 12, and 18|All randomized participants who received at least 1 dose of double-blind study medication in the Treatment Period. n=number evaluable||Units on a scale||Standard Error|Mean
820301|NCT01142726|Secondary|Adjusted Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Over Time|The Health Assessment Questionnaire Disability Index (HAQ-DI) assesses patients' functional ability by rating their abilities over the previous week. The HAQ-DI includes at least 2 questions from each of 8 categories: dressing and grooming, hygiene, arising, reach, eating, grip, walking, and common daily activities. Patients rate difficulty performing specific tasks: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The sum of the categories score (the highest scored item in the category) is divided by the number of categories answered, yielding a score from 0-3. When aids, devices, or help is indicated by the patient, the score for the category item is raised from a 0 or a 1 to a 2, but if the patient's highest score for a subcategory is a 3, it stays a 3.|Randomization to Month 18|All randomized participants who received at least 1 dose of double-blind study medication in the Treatment Period. n=number evaluable||Units on a scale||Standard Error|Mean
820302|NCT01142726|Secondary|Percentage of Participants Achieving a Health Assessment Questionnaire (HAQ) Response Over Time|HAQ response defined as a reduction of at least 0.3 units from baseline in score on the Health Assessment Questionnaire Disability Index (HAQ-DI), which assesses patients' functional ability by rating their abilities over the previous week. The HAQ-DI includes at least 2 questions from each of 8 categories: dressing and grooming, hygiene, arising, reach, eating, grip, walking, and common daily activities. Patients rate difficulty performing specific tasks: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The sum of the categories score (the highest scored item in the category) is divided by the number of categories answered, yielding a score from 0-3. When aids, devices, or help is indicated by the patient, the score for the category item is raised from a 0 or a 1 to a 2, but if the patient's highest score for a subcategory is a 3, it stays a 3.|Randomization to Month 24|All randomized participants who received at least 1 dose of double-blind study medication in the Treatment Period. Percentage calculated as a/b, where a=number of patients who achieved remission at Day x, and b=number of patients in the analysis.||Percentage of participants||95% Confidence Interval|Number
820303|NCT01142726|Secondary|Adjusted Mean Change From Baseline in Scores on Simplified Disease Activity Index (SDAI) Over Time|TP=treatment period; WP=withdrawal period. The SDAI is the simple linear sum of 5 outcome parameters: swollen joint count (SJC) and tender joint count (TJC) (based on a 28-joint assessment); patient's and physician's global assessments of disease activity (assessed on 0-10 cm visual analog scale, on which higher scores=greater affection due to disease activity); and C-reactive protein level (mg/dL). SDAI total score=0-86. SJC is assessed and recorded at each visit, with no swelling=0, swelling=1 (higher score indicates greater swelling). TJC is assessed at each visit through identification of joints that are painful under pressure or to passive motion, with no tenderness=0, tenderness=1 (higher score indicates greater affection due to disease activity)..|Randomization to Month 18|Intent to Treat (ITT) population. n= number of participants with both post baseline and baseline measurements.||Units on a scale||Standard Error|Mean
820304|NCT01142726|Secondary|Percentage of Participants Who Achieved Remission by Criteria of the Simplified Disease Activity Index (SDAI) at Months 12 and 18|TP=treatment period; WP=withdrawal period. SDAI-defined remission= ≤3.3. The SDAI is the simple linear sum of 5 outcome parameters: tender joint count (TJC) and swollen joint count (SJC) (based on a 28-joint assessment); patient's and physician's global assessments of disease activity (assessed on 0-10 cm visual analog scale, on which higher scores=greater affection due to disease activity); and C-reactive protein level (mg/dL). SDAI total score=0-86. SDAI <=3.3 indicates disease remission, >3.4 to 11=low disease activity, >11 to 26=moderate disease activity, and >26=high disease activity. TJC is assessed and recorded at each visit, with no swelling=0, swelling=1. SJC is assessed through identification of joints that are painful under pressure or to passive motion. TJC is recorded on the joint assessment form at each visit, with no tenderness =0, tenderness = 1. Higher score indicates greater affection due to disease activity.|Randomization to Month 18|All randomized participants who received at least 1 dose of double-blind study medication in the Treatment Period. Percentage calculated as a/b, where a=number of patients who achieved remission at Months 12 and 18, and b=number of patients in the analysis.||Percentage of participants||95% Confidence Interval|Number
820305|NCT01142726|Secondary|Adjusted Mean Change From Baseline in Disease Activity Score 28 Based on C-reactive Protein (DAS28-CRP) at Months 6, 12, and 18|TP=treatment period; WP=withdrawal period. The DAS 28-CRP is a measure of disease activity in rheumatoid arthritis (RA) that assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), CRP level (a measure of inflammation in the blood), and the patient’s global assessment of health (ranging from very good to very bad). DAS-CRP scores range from 0 to 10, with higher values indicating greater disease activity. Individual measures are fed into a complex mathematical formula to produce the overall DAS (a score greater than 5.1 implies active disease; less than 3.2, well controlled disease; and less than 2.6, remission.)|Baseline to Month 18|All randomized participants who received at least 1 dose of double-blind study medication in the Treatment Period. n=number evaluable||Units on a scale||Standard Error|Mean
820306|NCT01142726|Secondary|Percentage of Participants With Remission by Disease Activity Score 28 Based on C-reactive Protein (DAS28-CRP) Criteria Over Time - Intent to Treat Population|TP=treatment period; WP=withdrawal period. Remission defined as DAS28-CRP<2.6. The DAS 28-CRP is a measure of disease activity in rheumatoid arthritis (RA) and assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), CRP level (a measure of inflammation in the blood), and the patient’s global assessment of health (ranging from very good to very bad). DAS-CRP scores range from 0 to 10, with higher values indicating greater disease activity. Individual measures are fed into a complex mathematical formula to produce the overall DAS (a score greater than 5.1 implies active disease; less than 3.2, well controlled disease; and less than 2.6, remission.)|Randomization to Month 24|All randomized participants who received at least 1 dose of double-blind study medication in the Treatment Period. Percentage calculated as a/b, where a=number of patients who achieved remission at Day x, and b=number of patients in the analysis (intent to treat).||Percentage of participants||95% Confidence Interval|Number
820307|NCT01142726|Secondary|Percentage of Participants Who Received Monotherapy and Achieved Remission by Disease Activity Score 28 Based on C-reactive Protein (DAS28-CRP) Criteria at Month 12 and at Both Months 12 and 18|TP=treatment period; WP=withdrawal period. Remission defined as DAS28-CRP<2.6. The DAS 28-CRP is a measure of disease activity in rheumatoid arthritis (RA) that assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), CRP level (a measure of inflammation in the blood), and the patient’s global assessment of health (ranging from very good to very bad). DAS-CRP scores range from 0 to 10, with higher values indicating greater disease activity. Individual measures are fed into a complex mathematical formula to produce the overall DAS (a score greater than 5.1 implies active disease; less than 3.2, well controlled disease; and less than 2.6, remission.)|Randomization to Months 12 and 18|All randomized participants who received at least 1 dose of double-blind monotherapy in the Treatment Period. Percentage calculated as a/b, where a=number of patients who achieved remission at Month 12 and at both Months 12 and 18, and b=number of patients in the analysis. n=number evaluable||Percentage of participants||95% Confidence Interval|Number
820308|NCT01142726|Primary|Percentage of Participants Who Achieved Remission by Disease Activity Score 28 Based on C-reactive Protein (DAS28-CRP) Criteria at Month 12 and at Both Months 12 and 18|DAS28-CRP remission defined as <2.6; TP=treatment phase; WP=withdrawal phase. The DAS 28-CRP is a measure of disease activity in rheumatoid arthritis (RA) that assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), CRP level (a measure of inflammation in the blood), and the patient’s global assessment of health (ranging from very good to very bad). These measures are then fed into a complex mathematical formula to produce the overall DAS (a score greater than 5.1 implies active disease; less than 3.2, well controlled disease; and less than 2.6, remission.)|Randomization to Months 12 and 18|All randomized participants who received at least 1 dose of double-blind study medication in the Treatment Period. Percentage calculated as a/b, where a=number of patients who achieved remission at Month 12 and at both Months 12 and 18, and b=number of patients in the analysis. n=number evaluable||Percentage of participants|||Number
820309|NCT01142908|Secondary|HBA1C in Diabetic Patients|Lab values collected at interview visit by lab personnel|12 months|14 out of the 85 participants in the Pharmacist CVD group with diabetes at baseline and 15 out of the 86 participants in the Education Control group with diabetes at baseline had missing HBA1C at 6 months due to missing the 6 month interview entirely or not completing the lab assessment.||percentage of glycosylated hemoglobin||Standard Deviation|Mean
820310|NCT01142908|Secondary|HBA1C in Diabetic Patients|Lab values collected at interview visit by lab personnel|6 months|12 out of the 85 participants in the Pharmacist CVD group with diabetes at baseline and 11 out of the 86 participants in the Education Control group with diabetes at baseline had missing HBA1C at 6 months due to missing the 6 month interview entirely or not completing the lab assessment.||percentage of glycosylated hemoglobin||Standard Deviation|Mean
820311|NCT01142908|Secondary|HBA1C in Diabetic Patients|Lab values collected at interview visit by lab personnel|Baseline|4 out of the 85 participants in the Pharmacist CVD group with diabetes at baseline and 2 out of the 86 participants in the Education Control group with diabetes at baseline had missing data due to not having HBA1C collected at baseline.||percentage of glycosylated hemoglobin||Standard Deviation|Mean
820392|NCT01143402|Other Pre-specified|Apoptosis in the Paired Samples, Performed by Caspase 3 Cleavage|Changes will be assessed by a Wilcoxon test|Up to 5 years||||||
820313|NCT01142908|Secondary|Body Mass Index|Calculated from vitals (height & weight) obtained during interview|6 months|30 out of the 215 participants in the Pharmacist CVD group and 23 out of the 213 in the Education Control group had missing body mass index at 6 months due to missing the 6 month interview entirely or the interview was completed over the phone, or weight was not obtained at the 6 month interview.||kg/m^2||Standard Deviation|Mean
820314|NCT01142908|Secondary|Body Mass Index|Calculated from vitals (height & weight) obtained during interview|Baseline|5 out of the 215 participants in the Pharmacist CVD group and 1 out of the 213 participants in the Education Control group had missing data due weight and/or height not collected at baseline.||kg/m^2||Standard Deviation|Mean
820315|NCT01142908|Secondary|Cholesterol LDL|Collected during interview visit by lab personnel|12 months|34 out of the 215 participants in the Pharmacist CVD group and 27 out of the 213 in the Education Control group had missing cholesterol LDL at 12 months due to missing the 12 month interview entirely or not completing the lab assessment.||mg/dL||Standard Deviation|Mean
820316|NCT01142908|Secondary|Cholesterol LDL|Collected during interview visit by lab personnel|6 months|29 out of the 215 participants in the Pharmacist CVD group and 22 out of the 213 in the Education Control group had missing cholesterol LDL at 6 months due to missing the 6 month interview entirely or not completing the lab assessment.||mg/dL||Standard Deviation|Mean
820317|NCT01142908|Secondary|Cholesterol LDL|Collected during interview visit by lab personnel|Baseline|4 out of the 215 participants in the Pharmacist CVD group and 2 out of the 213 participants in the Education Control group had missing data due to not having cholesterol LDL collected at baseline.||mg/dL||Standard Deviation|Mean
820318|NCT01142908|Secondary|Medication Non-adherence|First 4 items of the 5 item Morisky Self-reported measure of medication adherence was used to determine medication non-adherence.|12 months|35 out of the 215 participants in the Pharmacist CVD group and 24 out of the 213 participants in the Education Control group had missing data for medication non-adherence due to missing the 12 month assessment or non-response of adherence items collected in the 12 month interview.||participants|||Number
820319|NCT01142908|Secondary|Medication Non-adherence|First 4 items of the 5 item Morisky Self-reported measure of medication adherence was used to determine medication non-adherence.|6 months|28 out of the 215 participants in the Pharmacist CVD group and 18 out of the 213 participants in the Education Control group had missing data for medication non-adherence due to missing the 6 month assessment or non-response of adherence items collected in the 6 month interview.||participants|||Number
820320|NCT01142908|Secondary|Medication Non-adherence|First 4 items of the 5 item Morisky Self-reported measure of medication adherence was used to determine medication non-adherence.|Baseline|5 out of the 215 participants in the Pharmacist CVD group and 2 out of the 213 participants in the Education Control group had missing data for medication non-adherence due to non-response of adherence items collected in the baseline interview.||participants|||Number
820321|NCT01142908|Primary|Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent)|"Components of the Framingham include gender, age fixed at baseline, systolic blood pressure (presence/absence of blood pressure medications at each time point [combination of administrative med data pull and self-report at assessment]), total cholesterol, HDL cholesterol, smoking status (assessed via self-report at each study survey), and diabetes (diabetes is a combination of self-report and CPRS data review). New cases of diabetes are allowed to be updated at 6 and 12 months f/u."|12 months|43 out of the 215 participants in the Pharmacist CVD group and 33 of the 213 participants in the Education Control group had missing data at 12 months due to entirely missing the 12 month assessment or having missing data on one or more of the Framingham components.||% 10 yr Risk||Standard Deviation|Mean
820322|NCT01142908|Primary|Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent)|"Components of the Framingham include gender, age fixed at baseline, systolic blood pressure (presence/absence of blood pressure medications at each time point [combination of administrative med data pull and self-report at assessment]), total cholesterol, HDL cholesterol, smoking status (assessed via self-report at each study survey), and diabetes (diabetes is a combination of self-report and CPRS data review). New cases of diabetes are allowed to be updated at 6 and 12 months f/u."|6 months|29 out of the 215 participants in the Pharmacist CVD group and 24 of the 213 participants in the Education Control group had missing data at 6 months due to entirely missing the 6 month assessment or having missing data on one or more of the Framingham components.||% 10 yr Risk||Standard Deviation|Mean
820323|NCT01142908|Secondary|Mean Diastolic Blood Pressure|Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews|12 months|36 out of the 215 participants in the Pharmacist CVD group and 30 out of the 213 in the Education Control group had missing blood pressure measurement at 12 months due to missing the 12 month interview entirely or blood pressure not collected at the 12 mo. assessment due to patient arm size exceeding cuff size or interview completed over the phone.||mmHg||Standard Deviation|Mean
820324|NCT01142908|Secondary|Mean Diastolic Blood Pressure|Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews|6 months|28 out of the 215 participants in the Pharmacist CVD group and 23 out of the 213 in the Education Control group had missing blood pressure measurement at 6 months due to missing the 6 month interview entirely or blood pressure not collected at the 6 month assessment due to patient arm size exceeding cuff size or interview completed over the phone.||mmHg||Standard Deviation|Mean
820325|NCT01142908|Secondary|Mean Diastolic Blood Pressure|Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews|Baseline|One out of the 215 participants in the Pharmacist CVD group did not have blood pressure collected at baseline.||mmHg||Standard Deviation|Mean
820326|NCT01142908|Secondary|Mean Systolic Blood Pressure|Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews|12 months|36 out of the 215 participants in the Pharmacist CVD group and 30 out of the 213 in the Education Control group had missing blood pressure measurement at 12 mo. due to missing the 12 month interview entirely or blood pressure not collected at the 12 month assessment due to patient arm size exceeding cuff size or interview completed over the phone.||mmHg||Standard Deviation|Mean
820393|NCT01143402|Other Pre-specified|PFS (Group 3)|Evaluated using a Simon mini-max design. Curves will be generated using Kaplan-Meier methodology.|4 months||||||
820394|NCT01143402|Other Pre-specified|Toxicity According to the National Cancer Institute Common Toxicity Criteria|Toxicity will be reported by type, frequency, and severity. Please see adverse events.|Up to 5 years||||||
820327|NCT01142908|Secondary|Mean Systolic Blood Pressure|Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews|6 months|28 out of the 215 participants in the Pharmacist CVD group and 23 out of the 213 in the Education Control group had missing blood pressure measurement at 6 months due to missing the 6 month interview entirely or blood pressure not collected at the 6 month assessment due to patient arm size exceeding cuff size or interview completed over the phone.||mmHg||Standard Deviation|Mean
820328|NCT01142908|Secondary|Mean Systolic Blood Pressure|Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews|Baseline|One out of the 215 participants in the Pharmacist CVD group did not have blood pressure collected at baseline.||mmHg||Standard Deviation|Mean
820329|NCT01142908|Primary|Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent)|"Components of the Framingham include gender, age fixed at baseline, systolic blood pressure (presence/absence of blood pressure medications at each time point [combination of administrative med data pull and self-report at assessment]), total cholesterol, HDL cholesterol, smoking status (assessed via self-report at each study survey), and diabetes (diabetes is a combination of self-report and VA Computerized Patient Record System (CPRS) data review). New cases of diabetes are allowed to be updated at 6 and 12 months f/u."|Baseline|Two out of the 215 participants in the Pharmacist CVD group had missing data due to not having the blood pressure component of the Framingham collected at baseline.||% 10 yr Risk||Standard Deviation|Mean
820330|NCT01143038|Secondary|Number of Participants Who Developed Antibodies to Romiplostim|The number of participants who developed antibody formation (defined as negative at baseline and positive at post-baseline, transient or persistent) to romiplostim, endogenous thrombopoietin (eTPO), and thrombopoietin mimetic peptide (TMP, the peptide component of romiplostim) was summarized.|Baseline and at end of treatment (based on response to treatment, this could occur between 12 months and approximately 18 months)|Safety analysis set participants with available results||participants|||Number
820331|NCT01143038|Secondary|Number of Participants With Adverse Events|An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant. The event does not necessarily have a causal relationship with study treatment. A serious adverse event is defined as an adverse event that meets at least one of the following serious criteria: • fatal • life threatening • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • congenital anomaly/birth defect • other significant medical hazard. Whether an adverse event was treatment-related (TRAE) or not was determined by investigator.|From first dose date of romiplostim to end of study (up to 24 months).|Safety analysis set||participants|||Number
820332|NCT01143038|Secondary|Percentage of Participants With Splenectomy During the 12-month Treatment Period|If treatment with romiplostim was deemed ineffective or intolerable by the investigator, a splenectomy may have been performed.|12 months|Safety analysis set||percentage of participants||95% Confidence Interval|Number
820333|NCT01143038|Secondary|Percentage of Participants With ITP Remission|ITP remission was defined as maintaining every platelet count ≥ 50 x 10^9/L for at least 6 months in the absence of romiplostim and any other therapies to treat ITP.|Up to 24 months|Safety analysis set||percentage of participants||95% Confidence Interval|Number
820334|NCT01143038|Primary|Number of Months With Platelet Response During the 12-Month Treatment Period|The primary endpoint was the number of months a participant achieved a platelet response during the 12-month treatment period. A platelet response for any 1 month was defined as the median of platelet counts measured in the month ≥ 50 x 10^9/L. Platelet counts within 4 weeks following a rescue medication use or following splenectomy were considered non-response. Months without any platelet count measurement were considered as months with no platelet response.|12 months|Safety Analysis Set includes all participants who received at least 1 dose of romiplostim.||months||Standard Error|Mean
820335|NCT01143051|Primary|Concentration vs. Time for Total Epinephrine From Time Zero to 6 Hours Post-dose|Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 5, 15, 30, 45, 60, 90, 120, 180, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method.|Pre-dose to 6 hours post-dose|Patients who : 1) have taken the valid pre-dose baseline PK sample 2) have correctly taken the randomized study-drug treatment 3) have at least 4 of the 5 post-dose PK measurements between 5 and 60 minutes post-dose available and 4) have a min of 8 of the 10 post-dose PK measurements for the entire 6 hour post-dose PK sampling period.||pg/mL||Standard Deviation|Mean
820336|NCT01143051|Primary|Half-life (t1/2) for Total Epinephrine|Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 5, 15, 30, 45, 60, 90, 120, 180, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Half-life (t1/2) is the amount of time it takes for epinephrine decrease to half the peak concentration in plasma during the treatment period.|Pre-dose to 6 hours post-dose|Patients who: 1) have taken the valid pre-dose baseline PK sample 2) have correctly taken the randomized study-drug treatment 3) have at least 4 of the 5 post-dose PK measurements between 5 and 60 min post-dose available; and 4) have a min of 8 of the 10 post-dose PK measurements for the entire 6 hour post-dose PK sampling period.||min||Full Range|Mean
820337|NCT01143051|Primary|Time to Reach Peak Concentration (Tmax) for Total Epinephrine|Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 5, 15, 30, 45, 60, 90, 120, 180, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. tmax is the amount of time it takes for epinephrine to reach peak concentration in plasma during the treatment period.|Pre-dose to 6 hours post-dose|Patients who : 1) have taken the valid pre-dose baseline PK sample 2) have correctly taken the randomized study-drug treatment 3) have at least four of the five post-dose PK measurements between 5 and 60 min post-dose available and 4) have a minimum of eight of the ten post-dose PK measurements for the entire 6 hour post-dose PK sampling period.||min||Standard Deviation|Mean
820395|NCT01143402|Other Pre-specified|Response Rate (Complete and Partial Response)|Calculated along with a 95% confidence interval.|Up to 5 years||||||
820479|NCT01144299|Primary|Hemagglutination Inhibition (HI) Antibody Titer|Titers given as geometric mean titer (GMT) were presented for all three vaccine influenza virus strains|Day 0 and Day 21|Analysis was performed on the According-To-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data||titer||95% Confidence Interval|Geometric Mean
820338|NCT01143051|Primary|Peak Concentration (Cmax) for Total Epinephrine From Time Zero to 6 Hours Post-dose|Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 5, 15, 30, 45, 60, 90, 120, 180, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Peak (maximum) concentration (Cmax) is the highest concentration of epinephrine measured in plasma during the treatment period.|Pre-dose to 6 hours post-dose|Patients who: 1) have taken the valid pre-dose baseline PK sample 2) have correctly taken the randomized study-drug treatment 3) have at least four of the five post-dose PK measurements between 5 and 60 min post-dose available and 4) have a minimum of eight of the ten post-dose PK measurements for the entire 6 hour post-dose PK sampling period.||pg/mL||Standard Deviation|Mean
820339|NCT01143051|Primary|Area Under the Curve From Time Zero to 6 Hours Post-dose (AUC[0-6])|Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 5, 15, 30, 45, 60, 90, 120, 180, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Area under the curve from time zero to 6 hours post-dose (AUC[0-6]) was calculated using the trapezoidal rule.|Pre-dose to 6 hours post-dose|Patients who: 1) have taken the valid pre-dose baseline PK sample 2) have correctly taken the randomized study-drug treatment 3) have at least four of the five post-dose PK measurements between 5 and 60 min post-dose available and 4) have a minimum of eight of the ten post-dose PK measurements for the entire 6 hour post-dose PK sampling period.||pg*min/mL||Standard Deviation|Mean
820340|NCT01143051|Secondary|Laboratory Analysis|Lab tests, including CBC, serum comprehensive metabolic panel, and urinalysis for all subjects, and urinary pregnancy test for women of child-bearing potential.|Screening, after each treatment and end of study, within 7 days of study visit 3||||||
820341|NCT01143051|Secondary|General Health Assessment|Physical examinations to assess general health|Screening and at or within 7 days after study visit 3||||||
820342|NCT01143051|Secondary|Hand Tremor|Hand tremor scores|at baseline, and at 10, 60, and 360 post-dose||||||
820343|NCT01143051|Secondary|Blood Values|Serum glucose and potassium levels;|at baseline, and at 15, 30, 60, 120, and 360 min post-dose||||||
820344|NCT01143051|Secondary|Telemetry and 12 Lead ECG Analysis|"Telemetry ECG recording of heart rate pre-dose, and during the initial 5 min post-dose.
A 12-lead ECG (Routine and QT / QTc intervals)at specified intervals"|within 30 min pre-dose, telemetry for 5 min post dose, 12 lead at 30, 90, and 360 min post-dose.||||||
820345|NCT01143051|Secondary|Vital Sign Analysis|Vital signs, i.e., blood pressure (SBP/DBP) and heart rate (HR);|at baseline, and at 10, 30, 60, 120, 180, and 360 min post-dose.||||||
820346|NCT01143051|Primary|Baseline Concentration (C0) of Labeled Epinephrine Total Epinephrine|Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at Baseline (prior to dosing) in each treatment period following a specified washout period (3-14 days), and were analyzed using an established analysis method. Baseline concentration (C0) is the concentration of epinephrine measured in the plasma at this time point.|0 to 30 minutes prior to dosing|Patients who: 1) have taken the valid pre-dose baseline PK sample 2) have correctly taken the randomized study-drug treatment 3) have at least four of the five post-dose PK measurements between 5 and 60 min post-dose available and 4) have a minimum of eight of the ten post-dose PK measurements for the entire 6 hour post-dose PK sampling period.||pg/mL||Standard Deviation|Mean
820347|NCT01143077|Secondary|Tolerability and Safety|Number of participants with Treatment Emergent Adverse Events and Serious Adverse Events|6 Weeks|||participants|||Number
820348|NCT01143077|Primary|Time to Relapse of Psychotic Symptoms During 6 Weeks|"Relapse is defined as any occurrence of:
Insufficient clinical response
Exacerbation of underlying disease
Discontinuation due to an adverse event"|6 Weeks|Intend to treat||days||Standard Deviation|Mean
820349|NCT01143090|Secondary|Efficacy|Long-term efficacy of lurasidone in subjects with schizophrenia or schizoaffective disorder who have completed Study D1050289|6 months||||||
820350|NCT01143090|Primary|Adverse Events|Proportions of subjects with AEs, SAEs, and discontinuations due to AEs.|6 months|Safety population - One enrolled subject did not receive any study medication and was excluded from this summary.||participants|||Number
820351|NCT01143142|Secondary|Vaccination of Daughter|With mother’s consent, daughter’s University of Michigan vaccination record will be accessed to determine whether daughter has received any doses of the HPV vaccine. If the University of Michigan vaccination record does not document a visit three months after the intervention, with mother’s consent, research staff will call mother at home to determine whether daughter has received any doses of the HPV vaccine.|Less than or equal to three months from the date of the intervention|||participants|||Number
820352|NCT01143142|Primary|Mother's Intention to Vaccinate Daughter Against HPV|Mother will rate her intention to have her daughter vaccinated against HPV using a Likert scale before and after the intervention. The scale ranges from 0-11 with higher numbers representing more positive intentions to vaccinate against HPV, and 5 being neutral intentions (i.e. neither positive nor negative). In this assessment we use this 11-point scale to assess vaccination before and after viewing the educational materials. The difference pre and post intervention in vaccination intention is calculated (min 0, max 11) and the mean of these differences are calculated for the control and intervention groups.|Date of intervention (one day)|||units on a scale||Full Range|Mean
820353|NCT01143207|Primary|MPA Concentration at Day 120 (C120)||day 120 after injection|||ng/mL||Standard Deviation|Mean
820354|NCT01143207|Primary|MPA Concentration at Day 104 (C104)||day 104 after injection|||ng/mL||Standard Deviation|Mean
820355|NCT01143207|Primary|MPA Concentration at Day 91 (C91)||day 91 after first injection|||ng/mL||Standard Deviation|Mean
820356|NCT01143207|Primary|AUC 0-91 (Area Under Curve)||first 91 days following injection|||ng day/mL||Standard Deviation|Mean
820357|NCT01143207|Primary|Tmax (Time to Cmax)||120 days following injection|||days||Inter-Quartile Range|Median
820358|NCT01143207|Primary|Cmax (Maximal Serum Concentration of Medroxyprogesterone Acetate (MPA))||120 days following injection|||ng/mL||Standard Deviation|Mean
820359|NCT01143259|Secondary|Hospital Cost|Total Cost of hospital stay inflation adjusted to 2010 dollars.|Upon discharge|The overall baseline number of participants is 274. The total number of participants that were included in the study was 248. There were 26 participants that either chose to not participate in the study after starting, or had protocol violations that excluded them from being included in the measured population.||Dollars||Full Range|Mean
820360|NCT01143259|Primary|Measure of Improvement Over the Standard|Determine if alvimopan addition to the multidisciplinary care process will result in decreased length of stay compared with the multidisciplinary care process plus placebo. Length of stay is determined by how many days a patient stays in the hospital. This is calculated by subtracting the discharge date from the admit date.|Number of days the patient stayed in the hospital [Time frame: Inpatient admit day to discharge day]|The overall baseline number of participants is 274. The total number of participants that were included in the study was 248. There were 26 participants that either chose to not participate in the study after starting, or had protocol violations that excluded them from being included in the measured population.||Days in the hospital||Full Range|Mean
820361|NCT01143272|Secondary|Total Number of Discontinuation or Change of Initially Prescribed Antibiotic||29 months|||participants|||Number
820362|NCT01143272|Secondary|Average Number of Bowel Movements in Patients With Antibiotic-associated Diarrhoea and Clostridium Difficile-associated Diarrhea||29 months|||bowel movements per day||Standard Deviation|Mean
820363|NCT01143272|Secondary|Average Duration of Antibiotic-associated Diarrhoea and Clostridium Difficile-associated Diarrhea||29 months|||days||Standard Deviation|Mean
820364|NCT01143272|Secondary|Incidence Density of Antibiotic-associated Diarrhea||29 months|||cases per year|||Number
820365|NCT01143272|Secondary|Total Number of Antibiotic-associated Diarrhea Episodes Without Evidence of Clostridium Difficile (Toxins)||29 months|||episodes|||Number
820366|NCT01143272|Secondary|Total Number of Clostridium Difficile-associated Diarrhea Episodes||29 months|||episodes|||Number
820367|NCT01143272|Primary|Total Number of Antibiotic-associated Diarrhea Episodes||29 months|||Episodes|||Number
820368|NCT01143324|Primary|Time to Surgery Recovery Day.|"The primary objective of the study is to access the short term recovery (from surgery to discharge) since the minimally invasive lumbar fusion techniques are expected to be associated with immediate short-term benefits. Patients undergoing minimally invasive procedures are reported to recover earlier from surgery particularly with a shorter time to first ambulation and shorter discharge as compared to the standard open procedures.
Surgery recovery day is defined as the day when patients fulfils following criteria : patient no longer needs intravenous infusion of analgesic drugs, there are no surgery related complications (AEs) impending discharge of patient, patient no longer needs nursing care. The objective of the surgery recovery day assessment is to collect the day when the patient could be discharged based on his actual clinical condition because the effective day of discharge may be prolonged by factors other than the patient's clinical recovery such as social factors."|From date of surgery until date of surgery recovery day assessed up to hospital discharge.|||Days||Standard Deviation|Mean
820369|NCT01143324|Secondary|Number of Patients That Returned to Work 12months After the Surgery.|Document number of participants that returned to work 12 months after surgery.|12 months after the surgery|||Participants currently working|||Number
820370|NCT01143324|Secondary|ODI Difference 12 Months After the Surgery as Compared to Baseline.|Oswestry Disability Index (ODI) 12 months after the surgery as compared to baseline. The Oswestry Disability Index (ODI) derives from the Oswestry Low Back Pain Questionnaire, it is used to measure disability for low back pain. The index is scored from 0 to 100; 0 meaning 'no disability' and 100 meaning 'maximum disability'.|Baseline, 12 months|||Units on a scale||Standard Deviation|Mean
820371|NCT01143324|Secondary|Document Adverse Events Occurrence Throughout the Study.|Document the Adverse Events occurrence throughout the study. All adverse events have been included regardless visit windowing.|From Baseline until 12 months|||Number of reported adverse events|||Number
820372|NCT01143324|Secondary|Document Change in Pain Medication Consumption Over Time as Compared With Baseline. Baseline.|Document the change in pain medication consumption one year after surgery , as compared with baseline. The endpoint is the number of participants taking pain medication at baseline and number of participants taking pain medication in the week before the 12 months follow up visit.|Baseline, 12 months|||Participants|||Number
820373|NCT01143324|Secondary|Proportion of Patients Needing Intervention at Adjacent Level(s).|Proportion of the patients needing intervention at adjacent level(s).|From Baseline until 12 months|||Participants|||Number
820374|NCT01143324|Secondary|Proportion of Patients Needing a Second Intervention at the Treated Level(s) (Reoperation Rates).|Proportion of the patients needing a second intervention at the treated level(s) (reoperation rates).|From baseline until 12 months|||Participants|||Number
820375|NCT01143324|Secondary|Number of Patients Who Utilized Rehabilitation Programs|The number of patients who utilized rehabilitation programs was documented (when required).|From 6-12 months after the day of surgery|||Pts having rehab between 6-12 months|||Number
820376|NCT01143324|Secondary|Fusion Rate as Assessed by CT Scan or X-Rays, in Those Sites Where This Assessment is Standard of Care.|Fusion rate as assessed by the CT Scan or X-Rays, in those sites where this assessment is standard of care.|12 months|One hundred and thirty one-level patients (=130 LEVELS) and 24 two-level patients (=48 LEVELS) were assessed for fusion at 12 months per CIP defined criteria.||Fused levels|Participants||Number
820377|NCT01143324|Secondary|EQ-5D Questionnaire (When it is a Routine Practice) as Compared to Baseline.|EQ-5D questionnaire as compared to baseline measurement. EQ-5D Index was calculated based on answers provided in the questionnaire. Applicable to a wide range of health conditions and treatments, the EQ-5D provides a simple descriptive profile and a single index value for health status. The EQ-5D-3L consists of the EQ-5D-3L descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. The respondent is asked to indicate his/her health state by ticking in the box against the most appropriate statement in each of the 5 dimensions. EQ VAS records the respondent’s self-rated health on a vertical 20 cm VAS where the endpoints are labelled ‘Best imaginable health state’ at the top and ‘Worst imaginable health state’ at the bottom, having numeric values of 100 and 0 respectively.|Baseline, 12 months|||Units on a scale / Index||Standard Deviation|Mean
820396|NCT01143402|Other Pre-specified|Overall Survival|The primary analysis will be performed among the Gnaq/Gna11 mutant patients. A stratified logrank test will be performed stratified by mutation status, M stage, and number of prior systemic therapies for metastatic disease. Due to the potential for a large number of strata and small strata sizes, the standard asymptotic stratified logrank test will be verified for robustness utilizing a permutation reference distribution.|The time from randomization to death due to any cause, assessed up to 5 years||||||
820378|NCT01143324|Secondary|Leg Pain Intensity VAS Score as Compared to Baseline|"Leg pain intensity (using VAS intensity score) as compared to baseline. Relief of Leg Pain intensity at 12 months compared to the baseline using the Back Pain Intensity Score assessed on a 10 cm Visual Analog Scale (VAS).
The endpoint is the difference between baseline and 12 months of the patient's leg-pain intensity score on a Visual Analogue Scale (VAS). A standardized visual analogue scale (0cm-10cm; with 0cm meaning 'no pain' and 10cm meaning 'worst possible pain') was used. Large values of the VAS score represent large degree of pain. Large (negative) change in VAS score (12 months - baseline) represents large relief of pain."|Baseline, 12 months|||Units on a scale||Standard Deviation|Mean
820379|NCT01143324|Secondary|Back Pain Intensity Visual Analog Scale (VAS) Score as Compared to Baseline.|"Relief of Back Pain intensity at 12 months compared to the baseline using the Back Pain Intensity Score assessed on a 10 cm Visual Analog Scale (VAS).
The endpoint is the difference between baseline and 12 months of the patient's back-pain intensity score on a Visual Analogue Scale (VAS). A standardized visual analogue scale (0cm-10cm; with 0cm meaning 'no pain' and 10cm meaning 'worst possible pain') was used. Large values of the VAS score represent large degree of pain. Large (negative) change in VAS score (12 months - baseline) represents large relief of pain."|Baseline, 12 months|||Units on a scale||Standard Deviation|Mean
820380|NCT01143324|Primary|Time From Surgery to First Ambulation.|"The primary objective of the study is to access the short term recovery (from surgery to hospital discharge) since the minimally invasive lumbar fusion techniques are expected to be associated with immediate short-term benefits. Patients undergoing minimally invasive procedures are reported to recover earlier from surgery particularly with a shorter time to first ambulation and shorter discharge as compared to the standard open procedures.
Outcome measure timeframe for time from surgery to first ambulation is assessed up to hospital discharge as pts are all ambulated before discharge from the hospital."|From date of Surgery to date of First ambulation, assessed up to hospital discharge.|||Days from surgery to first ambulation||Standard Deviation|Mean
820381|NCT01143337|Secondary|Percent Changes From the Pretreatment Values in the Disease Activity Score (DAS) 28, and ACR Components|ACR components are tender joints count (TJC), swollen joints count (SJC), participant assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ‐DI]); and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR).|LOCF (Week 12 or discontinuation time)|||percentage of change from baseline||Standard Deviation|Mean
820382|NCT01143337|Secondary|Changes From the Pretreatment Values in the Disease Activity Score (DAS) 28, and ACR Components|"DAS28 (CRP) is calculated using TJC, SJC C-Reactive Protein ( CRP in mg/dL ), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.36 x log (CRP+1) + 0.014 x Global Assessment of Arthritis + 0.96 where 28 joints are examined and a lower score indicates less disease activity.
DAS28 (ESR) is calculated using TJC, SJC erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x log (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity.
A negative change score indicates improvement. Higher score indicated more disease activity. DAS28 =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity."|LOCF (Week 12 or discontinuation time)|||units on a scale||Standard Deviation|Mean
820383|NCT01143337|Secondary|Percentage of Participants Achieving American College of Rheumatology 70 (ACR 70) Response|ACR 70 response is a decrease of at least 70 per cent in both tender and swollen joint count and in 3 to 5 assessments (participant's assessment of pain VAS with 0, no pain to 10, worst pain; patient's and physician's global assessment of disease activity VAS scales: overall disease activity [0, very well to 10, very poor and 0, no arthritis activity to 10, extremely active, respectively]; HAQ-DI: 20-questions on life activities [0, no difficulty to 3, inability to perform a task]; CRP).|Week 2, 4, 6, 8, 12, LOCF (Week 12 or discontinuation time)|||percentage of participants||95% Confidence Interval|Number
820384|NCT01143337|Secondary|Percentage of Participants Achieving ACR 50 Response|ACR 50 response is a decrease of at least 50 per cent in both tender and swollen joint count and in 3 to 5 assessments (participant's assessment of pain VAS with 0, no pain to 10, worst pain; patient's and physician's global assessment of disease activity VAS scales: overall disease activity [0, very well to 10, very poor and 0, no arthritis activity to 10, extremely active, respectively]; HAQ-DI: 20-questions on life activities [0, no difficulty to 3, inability to perform a task]; CRP).|Week 2, 4, 6, 8, 12, LOCF (Week 12 or discontinuation time)|||percentage of participants||95% Confidence Interval|Number
820385|NCT01143337|Primary|Percentage of Participants Achieving American College of Rheumatology 20 (ACR 20) Response|ACR 20 response is a decrease of at least 20 per cent in both tender and swollen joint count [TJC and SJC] and in 3 to 5 assessments (participant's assessment of pain visual analog scale [VAS] with 0, no pain to 10, worst pain; patient's and physician's global assessment of disease activity VAS scales: overall disease activity [0, very well to 10, very poor and 0, no arthritis activity to 10, extremely active, respectively]; Health Assessment Questionnaire [HAQ-DI]: 20-questions on life activities [0, no difficulty to 3, inability to perform a task]; C-reactive protein[CRP]).|Week 2, 4, 6, 8, 12, LOCF (Week 12 or discontinuation time)|||percentage of participants||95% Confidence Interval|Number
820386|NCT01143402|Other Pre-specified|FACT-M Total Score|Summarized using descriptive statistics for each assessment time and by treatment group. The scores will be compared between treatment groups using a mixed effect model for repeated measures analysis method. Treatment difference will be estimated from the model for each assessment time.|Up to 5 years||||||
820387|NCT01143402|Other Pre-specified|Changes in Maximum Standardized Uptake Value on FLT-PET Scans|A paired student's t-test will be performed. Analysis of variance will also be performed to obtain the significance of FLT-PET uptake on each lesion between patients.|Baseline up to 60 minutes post injection||||||
820388|NCT01143402|Other Pre-specified|Change in PTEN|Correlated with disease status using Fishers exact test.|Baseline up to 4 months||||||
820389|NCT01143402|Other Pre-specified|Change in p-ERK|Decrease in p-ERK will be correlated with disease status using Fishers exact test.|Baseline up to 4 months||||||
820390|NCT01143402|Other Pre-specified|Change in p-AKT|Correlated with disease status using Fishers exact test.|Baseline up to 4 months||||||
820391|NCT01143402|Other Pre-specified|Change in Ki67|Correlated with disease status using Fishers exact test.|Baseline up to 4 months||||||
820398|NCT01143402|Secondary|Median Overall Survival (Evaluable Randomized Patients)|The primary analysis will be performed among the Gnaq/Gna11 mutant patients. A stratified logrank test will be performed stratified by mutation status, M stage, and number of prior systemic therapies for metastatic disease. Due to the potential for a large number of strata and small strata sizes, the standard asymptotic stratified logrank test will be verified for robustness utilizing a permutation reference distribution.|The time from randomization to death due to any cause, assessed up to 5 years|||Months||95% Confidence Interval|Median
820399|NCT01143402|Primary|Progression-free Survival (PFS) (Evaluable Randomized Patients)|The primary analysis will be performed among the Gnaq/Gna11 mutant patients. A stratified logrank test will be performed stratified by mutation status, M stage, and number of prior systemic therapies for metastatic disease. Due to the potential for a large number of strata and small strata sizes, the standard asymptotic stratified logrank test will be verified for robustness utilizing a permutation reference distribution.|The time from randomization to the earlier date of objective disease progression per Response Evaluation Criteria In Solid Tumors (RECIST) criteria or death due to any cause in the absence of progression, assessed up to 5 years|Analysis of progression-free survival in all evaluable randomized patients||weeks||95% Confidence Interval|Median
820400|NCT01143610|Secondary|Gain of Clinical Attachment Level|Investigation of clinical attachment level, probing depth and reduction of recession depth|9 months post-operatively|The unit of analysis was the site, since each participant contributed with more than one site to be treated||mm|Participants|Standard Deviation|Mean
820401|NCT01143610|Primary|Percentage of Root Coverage|Percentage of root coverage determined by: [area covered]/[total area to be covered] x 100 (in %)|Baseline, 9 months post-operatively|The unity of analysis was the site, since each participant contributed with more than one site for treatment||percentage of area covered|Participants|Full Range|Mean
820402|NCT01143636|Secondary|Diffuse Noxious Inhibitory Controls - DNIC.|DNIC occurs when response from a painful stimulus (pain pressure threshold - PPT) is inhibited by another noxious stimulus (cold water). The difference between baseline and post treatment was compared between the 2 groups (real and sham) in patients with pelvic pain (Exp. 1).|baseline and at 2 weeks|patients with pelvic pain (Exp. 1).||lb||Standard Deviation|Mean
820403|NCT01143636|Secondary|Pain Pressure Threshold Test - PPT|Pressure pain threshold (PPT) is defined as the minimum force applied which induces pain.This test was applied before and after the treatment and the difference (post minus pre) was compared between the 2 groups (real and sham) in patients with pelvic pain (Exp 1).|baseline and at 2 weeks|Patients with pelvic pain (Exp. 1).||lb||Standard Deviation|Mean
820404|NCT01143636|Secondary|Von Frey|This test is used to test subjects' sensitivity to a mechanical stimulus. It was performed before and and after the treatment and the difference (post minus pre) was compared between the 2 groups (real and sham) in patients with pelvic pain (Exp. 1). A set of filaments, typically from 0.008 grams force up to 300 grams force, is applied on the patients' skin. The mechanical threshold is defined as the moment when the patient detects the stimulus.|baseline and at 2 weeks|Patients with pelvic pain (Exp. 1).||grams||Standard Deviation|Mean
820405|NCT01143636|Secondary|Patient Global Assessment - PGA|"This scale measures patient's assessment of general health. It was performed at the end of the treatment and compared between the 2 groups (real and sham) in patients with pelvic pain (Exp 1). The patient has to answer the question how is your health overall on a scale going from 0 to 10 (0 being the worst, 10 being the best)."|2 weeks|Patients with pelvic pain (Exp. 1).||units on a scale||Standard Deviation|Mean
820406|NCT01143636|Secondary|Beck Depression Inventory - BDI.|BDI is a questionnaire used for detecting depression. It was performed at the end of the treatment and compared between the 2 groups (real and sham) in patients with pelvic pain (Exp. 1). It is a 21-question multiple-choice self-report inventory (scores ranging from 0 to 63 - 0 corresponds to no symptom of depression).|2 weeks|Patients with pelvic pain (Exp. 1).||units on a scale||Standard Deviation|Mean
820407|NCT01143636|Secondary|Mini Mental Scale - MMS|This scale measures patients cognitive impairment. It was performed at the end of the treatment and compared between the 2 groups (real and sham) in patients with pelvic pain (Exp. 1). It is a 30 points scale (total scores ranging from 0 to 30), the highest score corresponds to the highest cognitive status.|2 weeks|Patients with pelvic pain (Exp. 1).||units on a scale||Standard Deviation|Mean
820408|NCT01143636|Secondary|Visual Analogue Scale - Anxiety.This Scale Measures Patients' Level of Anxiety on a Scale (0-no Anxiety to 10-worst Anxiety Ever). It Was Performed at the End of the Treatment and Compared Between the 2 Groups (Real and Sham) in Patients With Pelvic Pain|The scale was performed at the end of the treatment and compared between the 2 groups (real and sham) in patients with pelvic pain (Exp. 1).|2 weeks|This outcome measure was performed in patients with pelvic pain (Exp 1).||units on a scale||Standard Deviation|Mean
820409|NCT01143636|Secondary|Clinical Global Impression - CGI|This scale measures illness severity and was performed on patients with pelvic pain (Exp. 1). The scale was performed at end of the treatment and compared between the two groups (real and sham). The scale is divided in 3 sub-scales: Severity of illness (0-7), global improvement (0-7) and efficacy index (0-16), total scores ranging from 0 to 30. The highest scores corresponding to lowest clinical improvement.|2 weeks|Patients with pelvic pain (Exp 1)||units on a scale||Standard Deviation|Mean
820410|NCT01143636|Secondary|Quality of Life Scale (QOLS)|The questionnaire on quality of life was performed at the end of the treatment session and compared between the two groups (active and sham) in patients with pelvic pain (Exp. 1). The QOLS has 16 items (total scores ranging from 16 to 112) the highest scores corresponding the best QOL.|2 weeks|We compared active and sham groups (Exp. 1)||units on a scale||Standard Deviation|Mean
820411|NCT01143636|Primary|Pressure Pain Threshold|"Pressure pain threshold (PPT) is defined as the minimum force applied which induces pain.
The change in pressure pain threshold (post minus pre intervention) is use for the analysis."|baseline and at 2 weeks|The pain pressure test is performed in healthy participants (exp 2).||lb||Standard Deviation|Mean
820412|NCT01143636|Primary|Pain Assessment|We use the Visual analogue scale (VAS) to measure pain. The VAS is ranged from 0 to 10, with 0 reffering to no pain and 10 reffering the the worst possible pain. We used the difference between post treatment minus baseline to compare the two treatments (active versus sham tDCS).|baseline and at 2 weeks|The VAS is performed in patients with pelvic pain (Experiment 1).||units on a scale||Standard Deviation|Mean
820508|NCT01144598|Secondary|Anti-cyclic Citrullinated Peptide|Anti-cyclic citrullinated peptide (anti-CCP) test results.|Day 1|All participants with available information were included in the analysis.||Participants|||Number
820413|NCT01143649|Primary|Cortical Oscillations - EEG|Recording took place in a dim-lighted room set up with acoustic and electric isolation. EEG was acquired from 64-channels HydroCel Geodesic Sensor Net (Electrical Geodesic Inc., Eugene, OH) and recorded using Net Station running on a MacIntosh G4 computer. Alpha power were used as the main outcome measure. The difference values (e.g., post minus pre tACS) were used for the analysis. The alpha frequency is a brain oscillation that takes place especially when subjects are in a relaxed state, especially eyes closed. In the motor cortex, a decrease in alpha power has been seen during motor performance. Therefore, it could be speculated that a decrease in power in this study would indicate more engagement in motor cortex during the motor performance.|15 minutes|The brain oscillations measurements were only performed in the tACS study (Experiment 3).||microVolt^2||Standard Deviation|Mean
820414|NCT01143649|Primary|Cortical Excitability|"Motor evoked potential (MEP) Using Transcranial Magnetic Stimulation (TMS), MEP were recorded before and after tDCS (both active and sham).
The percentage of change in MEP (post versus pre intervention) between the two groups (active and sham) were used for the comparison."|1 hour|The cortical excitability measurement (MEP) was performed in healthy participants involved in the tDCS+CIMT study (Experiment 2).||percent change||Standard Deviation|Mean
820415|NCT01143649|Primary|Jebsen Taylor Hand Function Test|Jebsen Taylor Hand Function Test: measures hand function in real-life activities, by evaluating the time required to perform 7 different tasks. We used the non-cronstrained hand for the assessments. The sum of the different tasks was used for the analysis.|2 weeks|The Jebsen Taylor Hand Function Test was only performed in the stroke study (Experiment 1).||seconds||Standard Error|Mean
820416|NCT01143688|Secondary|Asthma Symptoms|Subjective change in asthma symptoms on a visual-analogue scale with scores ranging from 0 (no positive change) to 10 (complete positive change). These subjective responses were then converted to percent change during the 2 hours by multiplying each score by 10. Each of these individual subject scores were then averaged to produce an average percent change in symptoms.|Assesed over 2 hours during each visit. There were 4 visits in each block each visit separated by 3-7 days. There were three blocks each block separated by 3-7 days.|||percent change in symptoms||Standard Error|Mean
820417|NCT01143688|Primary|Change in FEV1|The baseline FEV1 (before treatment) was subtracted from the maximum FEV1 recorded during the 2 h period following treatment. This difference value was then converted into percent improvement by dividing by baseline FEV1 and multiplying by 100. Each treatment was given 3 times to each patient, so we averaged the 3 values to yield the mean percent change in FEV1 for each condition.|FEV1 was assessed every 20 minutes for 2 hours at each visit. There were 4 visits in each block each visit separated by 3-7 days. There were three blocks each block separated by 3-7 days.|Each patient went through each treatment arm (albuterol, placebo inhaler, placebo acupuncture, and no-intervention) once in block 1, then again in block 2, and again in block 3, for a total of 12 interventions of the course of the study.||percentage change in FEV1||Standard Error|Mean
820418|NCT01143701|Primary|Teacher-rated ADHD Symptoms|Total Symptom Score on Teacher-Rated Vanderbilt ADHD Rating Scale (range=0-54). Higher scores represent more severe ADHD symptom presentation.|12 months|Analyses only included patients who had a post-intervention teacher-rated ADHD scale. Hierarchical Modeling accounted for clustering of patients nested within providers and providers nested within practices.||scores on a scale|Participants|Standard Deviation|Mean
820419|NCT01143701|Primary|Parent-rated ADHD Symptoms|Total Symptom Score on Parent-Rated Vanderbilt ADHD Rating Scale (range=0-54). Higher scores represent more severe ADHD symptom presentation.|12 months|Hierarchical Modeling accounted for clustering of patients nested within providers and providers nested within practices.||scores on a scale|Participants|Standard Deviation|Mean
820420|NCT01143714|Secondary|Number of Sharp Debridements Performed During the 4-week Treatment Phase and the 8-week Follow-up Period (12 Weeks Total)||12 weeks|Intent-to-Treat population||debridements||Standard Error|Least Squares Mean
820421|NCT01143714|Primary|Change in Wound Area|The primary efficacy endpoint was the percent change in wound area from baseline to completion of the 4-week treatment phase and the 8-week follow-up period|4 Weeks|Sample size originally set at 100 to provide 80% power, a=0.05. Interim analysis when enrollment reached 50 indicated results would not change with additional enrollment. Intent-to-treat used for primary inference; Missing values imputed by method of population mean and last observation carried forward (wound area).||percentage of average change in wound||Standard Error|Least Squares Mean
820422|NCT01143727|Secondary|Percent Change in Wound Area||28 days|Intent-to-Treat||percentage change from baseline area||Standard Deviation|Mean
820423|NCT01143727|Primary|Wound Appearance|Weekly wound appearance as assessed by BWAT-m scores. BWAT-m scores used to determine primary efficacy consist of 8 subscales, each grade an aspect of wound status on a 1-5 scale; 1=normal intact skin; 5=least desirable. Total score=8-40. Subscales: Edges, Undermining, Necrotic Tissue Type, Necrotic Tissue Amount, Exudate Type, Exudate Amount, Skin Color Surrounding Wound, and Granulation Tissue.|28 days|12 subjects initially for this exploratory study. 17 subjects enrolled to ensure 12 evaluable. Intent-to-treat used for primary inference. Missing values imputed by method of population mean (BWAT-m) and last observation carried forward (wound area).||units on a scale||Standard Deviation|Mean
820424|NCT01143766|Secondary|Efficacy|Assess the effect of a single 900mg dose of gabapentin pre-ERCP on pre and post procedure pain, anxiety and nausea as reported on visual analog scales.|At time of discharge post-procedure||||||
820425|NCT01143766|Secondary|Safety|Measure sedation-related adverse events|At time of discharge post-procedure||||||
820426|NCT01143766|Primary|Dosing Requirements|Assess the effect of a single 900mg dose of gabapentin pre- ERCP on intra and post procedure narcotic/sedative requirements.|At time of discharge post-procedure|TOTAL DOSE OF MEPERIDINE||TOTAL DOSE OF MEPERIDINE, mg||Inter-Quartile Range|Median
820427|NCT01143792|Primary|Substance Use|Percentage of substance use days in prior six months|Twelve months|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included int he analysis.||percent days of drug use||Standard Deviation|Mean
820428|NCT01143792|Primary|Substance Use|Percentage of substance use days in prior three months|Six months|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.||percent days of drug use||Standard Deviation|Mean
820721|NCT01141660|Primary|Number of Participants With Laryngospasm||2 years|||Participants|||Number
820429|NCT01143792|Secondary|Depressive Symptoms|Beck Depression Inventory - II (BDI-II) total score, range from 0 (no depression)to 63 (severe depression)|Twelve months|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.||units on a scale||Standard Deviation|Mean
820430|NCT01143792|Secondary|Depressive Symptoms|Beck Depression Inventory - II (BDI - II) Range from 0 (no depression) to 63 (severe depression)|Six months|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.||units on a scale||Standard Deviation|Mean
820431|NCT01143792|Secondary|Depressive Symptoms|Beck Depression Inventory - II (BDI-II) total score, range from 0 (no depresion)to 63 (severe depression)|Three months|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.||units on a scale||Standard Deviation|Mean
820432|NCT01143792|Secondary|HIV Risk|Frequency of condoms use in prior six months.|Twelve months|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.||participants who always used condoms|||Number
820433|NCT01143792|Secondary|HIV Risk|Frequency of condoms use in prior three months.|Six months|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.||participants who always used condoms|||Number
820434|NCT01143792|Secondary|HIV Risk|Frequency of condoms use in prior three months.|Three months|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.||participants who always used condom|||Number
820435|NCT01143792|Primary|Substance Use|Percentage of substance use days in prior three months.|Three months|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.||percent days of drug use||Standard Deviation|Mean
820436|NCT01143818|Secondary|Percent Change From Baseline to Month 6 in Body Mass Index (BMI)|The BMI was measured in kg/m^2 and was reported at baseline and at the Month 6. BMI = weight (kg)/[(height (m) x height (m)] and was measured to 1 decimal point precision.|Baseline to Month 6|The full analysis set included all participants in the safety analysis set who had BMI available at baseline and Month 6.||Percent Change||Standard Deviation|Mean
820437|NCT01143818|Secondary|Percent Change From Baseline to Month 6 in the Multidimensional Fatigue Inventory (MFI) Total Score|The MFI is a 20-item self-reported instrument designed to measure fatigue. Five scales measure different modes of fatigue: general fatigue (4 items), physical fatigue (4 items), mental fatigue (4 items), reduced motivation (4 items), and reduced activity items (4 items). The scores for each item range from 1 to 5. Each subscale includes 4 items with 5-point Likert scales and subscale scores range from 4 to 20 with a higher score indicating greater fatigue. The percent change=[(MFI value at Month 6-MFI value at baseline)/MFI baseline value] X 100.|Baseline to Month 6|The full analysis set included all participants in the safety analysis set who had an MFI score available at baseline and Month 6.||Percent Change||Standard Deviation|Mean
820438|NCT01143818|Secondary|Percent Change From Baseline to Month 6 in the International Index of Erectile Function (IIEF) Total Score|The International Index of Erectile Function (IIEF) test is a validated 15 question assessment designed to measure changes in erectile function (6 items), orgasmic function (2 items), sexual desire (2 items), intercourse satisfaction (3 items), and overall satisfaction (2 items). The scores ranged from 0 to 5 on each item with a lower score indicating greater dysfunction. A total IIEF score of 0 (minimum) to 75 (maximum) was possible and represented the sum of all the items at baseline and Month 6. The percent change = [(IIEF value at Month 6-IIEF baseline value)/IIEF baseline value]x 100.|Baseline to Month 6|The full analysis set included all participants in the safety analysis set who had an IIEF score available at baseline and Month 6.||Percent Change||Standard Deviation|Mean
820439|NCT01143818|Primary|Percent Change From Baseline to Month 6 in Aging Male Symptoms (AMS) in Mean Total Score|The Aging Male Symptoms (AMS) test is self-administered and designed to assess symptoms of aging with a rating from none (0) to extremely severe (5) for 17 items from psychological (5 items), somatic (7 items), and sexual (5 items) categories. Total scores range from 17 (minimum) to 85 (maximum). The AMS total score was reported at baseline and at Month 6 and represented the sum of all the items. The percent change from baseline was calculated as the [(AMS value at Month 6 - AMS value at baseline)/baseline value] x 100.|Baseline to Month 6|The full analysis set included all participants in the safety analysis set who had an Aging Male Symptoms (AMS) score available at baseline and Month 6.||Percent Change||Standard Deviation|Mean
820440|NCT01143883|Primary|Surgical Site Infection|We will monitor the incision from the day of surgery to post operative day 30 to determine if the incision needs antibiotics.|Day of surgery up to 30 days post operatively|The number of participants analyzed was based on the number who received treatment according to their randomized group and were treated according to study protocol||percentage of participants with SSI|||Number
820441|NCT01143896|Primary|Depression Care: Change From Baseline in Number of Depression Free Days (DFDs) at 12 Months|The change in Depression Free Days was assessed using the item mean score from the 20-item Hopkins Symptom Checklist (SCL-20) collected at baseline and 12-months. The SLC-20 items are scored from 0 to 4 and averaged to provide a mean depression severity score ranging from 0 to 4. Depression-free days (DFDs) were calculated using an SCL-20 score of less than 0.5 for depression-free and 2.0 or higher for fully symptomatic, and scores in between were assigned a linear proportional value.|From Baseline to 12 months|||Depression Free Days (DFDs)||Standard Deviation|Mean
820442|NCT01143896|Primary|Depression Care: Depression Remission|Depression outcomes were assessed using the item mean score from the 20-item Hopkins Symptom Checklist (SCL-20) collected at baseline and 12-months. The SLC-20 items are scored from 0 to 4 and averaged to provide a mean depression severity score ranging from 0 to 4. Remission was defined as an item mean SCL-20 score of less than 0.5.|Baseline and 12 months|||participants|||Number
820509|NCT01144598|Secondary|Rheumatoid Factor|Rheumatoid factor test results.|Day 1|All participants with available information were included in the analysis.||Participants|||Number
820443|NCT01143896|Primary|Depression Care: Treatment Response|Depression outcomes were assessed using the item mean score from the 20-item Hopkins Symptom Checklist (SCL-20) collected at baseline and 12-months. The SLC-20 items are scored from 0 to 4 and averaged to provide a mean depression severity score ranging from 0 to 4. Depression treatment response was defined as a 50% or greater decrease in the mean SCL-20 score compared with baseline.|Baseline and 12 months|||participants|||Number
820444|NCT01143896|Secondary|Medication Adherence: Medication Possession Ratio|Medication adherence was measured using the Medication Possession Ratio (MPR) calculation: Pharmacy refill data was used to calculate a medication possession ratio (MPR), by dividing the number of days supply of a medication received by the number of day’s supply the patient needed to be able to take the medication continuously. An MPR closer to 1.0 indicates better adherence and has been associated with lower rates of hospital admission in veterans and greater symptom improvement.|12 months|||medication posession ratio||Standard Deviation|Mean
820445|NCT01143896|Secondary|Quality of Hepatitis C Care: Quality Indicators: Proportion of QIs Received|Quality of CHC Indicator Measure is based on a Delphi panel-derived list of quality indicators (QI) in CHC care. The list spans the following domains of care, i.e., CHC-specific function of care (diagnosis, specialty evaluation, treatment, etc); general function of care (diagnosis, treatment, follow-up); and mode of care (encounter, medication, immunization, counseling, etc). Adherence to a given QI is scored as 1 if there is evidence in the patient EMR for the indicator being satisfied. The quality of CHC care at the patient level is calculated by dividing the number of QIs for which that individual received the indicated care by the number of QIs for which the individual is eligible for during the length of time the patient is enrolled in the HEP-TIDES 12-month study timeframe.|12 months|||proportion of QIs met||Standard Deviation|Mean
820446|NCT01143896|Primary|Number of Patients Who Initiated Hepatitis C Antiviral Treatment Within 12 Months of Enrollment|Antiviral treatment initiation was measured dichotomously by assigning a value of 1 if the patient received at least one prescription of interferon within 12 months of enrollment, and a value of 0 otherwise.|12 months|intent to treat||participants|||Number
820447|NCT01144026|Primary|Anti-Tat Antibody Titer|ELISA based chemiluminescent assay to determine the anti-Tat antibody response|5 weeks|all participants enrolled were analyzed||ng/mL||Full Range|Median
820448|NCT01144052|Secondary|Number of Infections||12 months|||events|||Number
820449|NCT01144052|Secondary|Number of Patients With Adverse Events|Recording and reporting according to regulations. Monthly assessments or if necessary.|12 months|All patients enrolled and randomized were analyzed.||participants|||Number
820450|NCT01144052|Secondary|MRI Parameters|Number of new T2-hyperintense lesions, Number of Gd-enhancing lesions on T1-weighted images. Assessments at month 3, 6, 9, 12, 18, 24.|12 months|All enrolled and randomized patients were analyzed.||Lesions||Full Range|Median
820451|NCT01144052|Secondary|Severity of Relapses|Change of Expanded Disability Status Scale (EDSS 1-10). Higher values represent a worser outcome.|12 months vs baseline|||units on a scale||Full Range|Median
820452|NCT01144052|Secondary|Proportion of Relapse Free Patients||12 months|||participants|||Number
820453|NCT01144052|Secondary|Number of Relapses||12 months|||number of events|||Number
820454|NCT01144052|Secondary|Number of Participants With Relapses||12 months|All enrolled and randomized patients were analyzed.||participants|||Number
820455|NCT01144052|Primary|Number of Days Until First On-study Relapse|Patients were followed-up during 12 months and time to first on-study relapse from randomization was recorded.|12 months|All enrolled and randomized patients fulfilled the criteria for analysis.||days||Full Range|Median
820456|NCT01144182|Secondary|Emotional Subscale of Heart Failure Specific Quality of Life|Subscale of the Minnesota Living with Heart Failure Questionnaire (HF-specific quality of life measure). Scores range from 0-25, with higher scores indicating poorer QOL.|3 months after discharge|51 patients in CBP and 47 patients in QIP had a follow-up visit. However, 1 participant in each arm did not complete the Minnesota Living with Heart Failure Questionnaire, such that there are only 50 participants analyzed in CBP and 46 in QIP for this outcome.||units on a scale||Inter-Quartile Range|Median
820457|NCT01144182|Primary|Heart Failure Specific Quality of Life|Measured by Minnesota Living with Heart Failure Questionnaire. Scores range from 0-105, with higher scores indicating poorer QOL.|3 months after discharge|51 patients in CBP and 47 patients in QIP had a follow-up visit. However, 1 participant in each arm did not complete the MLHFQ, such that there are only 50 participants analyzed in CBP and 46 in QIP for this outcome.||units on a scale||Inter-Quartile Range|Median
820458|NCT01144182|Secondary|Physical Subscale of Heart Failure Specific Quality of Life|Subscale of the Minnesota Living with Heart Failure Questionnaire (HF-specific quality of life measure). Scores range from 0-40, with higher scores indicating poorer QOL.|3 months after discharge|51 patients in CBP and 47 patients in QIP had a follow-up visit. However, 1 participant in each arm did not complete the Minnesota Living with Heart Failure Questionnaire, such that there are only 50 participants analyzed in CBP and 46 in QIP for this outcome.||units on a scale||Inter-Quartile Range|Median
820459|NCT01144182|Primary|General Quality of Life From the Standardized Physical Component Score|Assesses General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life|3 months after discharge|51 patients in CBP and 47 patients in QIP had a follow-up visit. However, 1 participant in each arm did not complete the VR-36, such that there are only 50 participants analyzed in CBP and 46 in QIP for this outcome.||units on a scale||Inter-Quartile Range|Median
820460|NCT01144182|Secondary|Mental Health|Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life|3 months after discharge|51 patients in CBP and 47 patients in QIP had a follow-up visit. However, 1 participant in each arm did not complete the VR-36, such that there are only 50 participants analyzed in CBP and 46 in QIP for this outcome.||units on a scale||Inter-Quartile Range|Median
820461|NCT01144182|Secondary|Role Emotional|Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life|3 months after discharge|51 patients in CBP and 47 patients in QIP had a follow-up visit. However, 1 participant in each arm did not complete the VR-36, such that there are only 50 participants analyzed in CBP and 46 in QIP for this outcome.||units on a scale||Inter-Quartile Range|Median
820510|NCT01144598|Secondary|Number of Comorbidities|Number of comorbid (coexisting) medical conditions of the study participants.|Day 1|All participants with available information were included in the analysis.||Participants|||Number
820462|NCT01144182|Secondary|Social Functioning|Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life|3 months after discharge|51 patients in CBP and 47 patients in QIP had a follow-up visit. However, 1 participant in each arm did not complete the VR-36, such that there are only 50 participants analyzed in CBP and 46 in QIP for this outcome.||units on a scale||Inter-Quartile Range|Median
820463|NCT01144182|Secondary|Vitality|Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life|3 months after discharge|51 patients in CBP and 47 patients in QIP had a follow-up visit. However, 1 participant in each arm did not complete the VR-36, such that there are only 50 participants analyzed in CBP and 46 in QIP for this outcome.||units on a scale||Inter-Quartile Range|Median
820464|NCT01144182|Secondary|General Health|Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life|3 months after discharge|51 patients in CBP and 47 patients in QIP had a follow-up visit. However, 1 participant in each arm did not complete the VR-36, such that there are only 50 participants analyzed in CBP and 46 in QIP for this outcome.||units on a scale||Inter-Quartile Range|Median
820465|NCT01144182|Secondary|Pain Index|Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life|3 months after discharge|51 patients in CBP and 47 patients in QIP had a follow-up visit. However, 1 participant in each arm did not complete the VR-36, such that there are only 50 participants analyzed in CBP and 46 in QIP for this outcome.||units on a scale||Inter-Quartile Range|Median
820466|NCT01144182|Secondary|Role Physical|Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life|3 months after discharge|51 patients in CBP and 47 patients in QIP had a follow-up visit. However, 1 participant in each arm did not complete the VR-36. Additionally, a second participant in CBP did not complete the role physical subscale items, leaving a total of 49 in CBP and 46 in QIP for this outcome.||units on a scale||Inter-Quartile Range|Median
820467|NCT01144182|Secondary|Physical Functioning|Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life|3 months after discharge|51 patients in CBP and 47 patients in QIP had a follow-up visit. However, 1 participant in each arm did not complete the VR-36, such that there are only 50 participants analyzed in CBP and 46 in QIP for this outcome.||units on a scale||Inter-Quartile Range|Median
820468|NCT01144182|Secondary|Standardized Mental Component Score|Assesses General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life|3 months after discharge|51 patients in CBP and 47 patients in QIP had a follow-up visit. However, 1 participant in each arm did not complete the VR-36, such that there are only 50 participants analyzed in CBP and 46 in QIP for this outcome.||units on a scale||Inter-Quartile Range|Median
820469|NCT01144286|Secondary|Dose-response of Clinical and Mycological (Global)Therapeutic Response|Global therapeutic response at day 8± 2 days. Safety and tolerability.|Day 8 ± 2 days|Dose response tested using logistic regression-linear coefficient for treatment effect.Assuming response rate 80% for 600 mg, 75% for 300 mg, 65% for 150 mg and 50% for the placebo group, sample size of 45 subjects in each group have 90% power to detect linear dose response with 0.05 two-sided test of trend based on the logistic model.||percentage of cured participants||95% Confidence Interval|Number
820470|NCT01144286|Primary|Dose-response of Clinical and Mycological (Global) Therapeutic Response|"Global therapeutic response at day 26± 4 days (TOC- Test-of-Cure visit).Global therapeutic response is a composite endpoint using the clinical (signs and symptoms) and the mycological cures (microbiological culture), according to FDA guideline Vulvovaginal Candidiasis —Developing Antimicrobial Drugs for Treatment."|day 26 ± 4 days|The full analysis set (FAS) was the primary population for the analysis of all efficacy endpoints. The FAS was defined as all randomized subjects who received at least 1 dose of a study drug.Subjects in the FAS were analyzed according to randomized treatment group.||percentage of patients cured||95% Confidence Interval|Number
820471|NCT01144299|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|An SAE is any untoward medical occurrence that: results in death, is lifethreatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|During the entire study period (From Day 0 up to Day 21)|||subjects|||Number
820472|NCT01144299|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product|During the 21-day (Day 0-20) post-vaccination period|||subjects|||Number
820473|NCT01144299|Secondary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, shivering, sweating, and fever.|During the 4-day (Day 0-3) post-vaccination period|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data||subjects|||Number
820474|NCT01144299|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include ecchymosis, induration, pain, redness, and swelling.|During the 4-day (Day 0-3) post-vaccination period|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data||subjects|||Number
820475|NCT01144299|Primary|Seroprotection Power|Seroprotection power is defined as the number of subject who had a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:40|Day 21|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available data||subjects|||Number
820476|NCT01144299|Primary|Seroconversion Factor|Seroconversion factor, defined as the fold increase in serum HI GMT post-vaccination compared to pre-vaccination (Day 0), is presented for all three vaccine influenza virus strains|Day 21|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available data||fold increase||95% Confidence Interval|Mean
820477|NCT01144299|Primary|Number of Seroconverted Subjects|A seroconverted subject is a subject with a pre-vaccination serum HI titer < 1:10 and a post-vaccination serum HI titer ≥ 1:40, or a pre-vaccination serum HI titer ≥ 1:10 and a fold increase (Day 21/Day 0) ≥ 4|Day 21|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available data||subjects|||Number
820511|NCT01144598|Secondary|Stiffness Duration|Participants' duration of morning joint stiffness.|Day 1|All participants with available information were included in the analysis.||Participants|||Number
820480|NCT01144364|Secondary|Duration of Response Using the Competing Risk Approach - Cumulative Percentage of Participants With Progression, Relapse or Death as a Result of FL at 12, 24, and 34 Months|DOR was defined for all participants who achieved a response (CR, CRu, and PR) at Month 3 or later, after the completion of induction phase and was measured from the date of randomization until the date of progression, relapse, or death as a result of FL. Participants without relapse, progression, or death for causes other than FL were censored at their last assessment date. Analyses on this endpoint were performed with two different approaches. For the competing risk approach, deaths for causes other than FL were considered as competing events. DOR was estimated with the cumulative incidence of progression, relapse, or death as a result of FL.|Months 12, 24, and 34|ITT Population||percentage of participants||95% Confidence Interval|Number
820481|NCT01144364|Secondary|Duration of Response Using a Traditional Approach - Percentage of Participants Estimated to Have a Sustained Response at 12, 24, and 34 Months|Duration of response (DOR) was defined for all participants who achieved a response (CR, CRu, and PR) at Month 3 or later, after the completion of induction phase and was measured from the date of randomization until the date of progression, relapse, or death as a result of follicular lymphoma (FL). Participants without relapse, progression, or death for causes other than FL were censored at their last assessment date. Analyses on this endpoint were performed with two different approaches. For the traditional approach, duration of response was estimated as the proportion of participants alive without progression or relapse of disease with the Kaplan-Meier method.|Months 12, 24, and 34|ITT Population||percentage of participants||95% Confidence Interval|Number
820482|NCT01144364|Secondary|Percentage of Participants With a Molecular Response in the Induction Phase|Molecular responders were defined as the proportion of CR/CRu participants with a positive bcl-2/IgH (non-Hodgkin's Lymphoma [NHL] marker) at baseline, whose laboratory values were undetectable after treatment.|Months 5 and 8|IP population; only participants with a positive bcl-2/IgH (NHL marker) at baseline were included in the analysis.||percentage of participants|||Number
820483|NCT01144364|Secondary|Percentage of Participants With a Response During the Induction Phase|Participants without a response assessment (due to any reasons) were considered as non-responders.|Months 1 to 8|ITT population.||percentage of participants|||Number
820484|NCT01144364|Primary|PFS Randomization- Percentage of Participants Estimated to be Free of Progression at 12, 24, and 34 Months|PFS from randomization was measured from the date of randomization to the date of documented disease progression, relapse, or death from any cause. Responding participants and participants who were lost to follow-up were censored at their last assessment date. PFS was estimated using Kaplan-Meier methods.|12, 24, and 34 months|ITT population||percentage of participants||95% Confidence Interval|Number
820485|NCT01144364|Secondary|OS From Enrollment - Percentage of Participants Estimated to be Alive at 12, 24, and 36 Months|OS from enrollment was defined as the date of enrollment to the date of death from any cause. Participants still alive at the time of the final analysis were censored at the date of the last contact. Estimates of the OS function were made by the Kaplan-Meier product-limit method.|12, 24, and 36 months|IP population||percentage of participants||95% Confidence Interval|Number
820486|NCT01144364|Secondary|Overall Survival (OS) From Randomization - Percentage of Participants With Death|OS from randomization was defined as the date of randomization to the date of death from any cause. Participants still alive at the time of the final analysis were censored at the date of the last contact. Estimates of the OS function were made by the Kaplan-Meier product-limit method.|12, 24, and 34 months|ITT population.||percentage of participants|||Number
820487|NCT01144364|Secondary|Overall Survival (OS) From Randomization - Percentage of Participants Estimated to be Alive at 12, 24, and 34 Months|OS from randomization was defined as the date of randomization to the date of death from any cause. Participants still alive at the time of the final analysis were censored at the date of the last contact. Estimates of the OS function were made by the Kaplan-Meier product-limit method.|12, 24, and 34 months|ITT population.||percentage of participants||95% Confidence Interval|Number
820488|NCT01144364|Secondary|Disease-Free Survival (DFS) From Randomization - Percentage of Participants Disease Free at 12, 24, and 36 Months|DFS was defined for all participants who achieved a complete response (CR) or unconfirmed CR (CRu) at Month 3 or later, after the completion of induction phase and was measured from the time of randomization to the date of relapse or death as a result of lymphoma or acute toxicity of treatment. Participants without relapse were censored at their last assessment date. Estimates of DFS were made using Kaplan-Meier product-limit method.|12, 24, and 36 months|ITT population||percentage of participants||95% Confidence Interval|Number
820489|NCT01144364|Secondary|Percentage of Participants Estimated to be Free of Progression at 12, 24, and 36 Months|PFS from enrollment was measured from the date of enrollment to the date of disease progression, relapse, or death from any cause. Responding participants and participants who were lost to follow-up were censored at their last assessment date. Estimates of PFS function were made with the Kaplan-Meier product-limit method.|12, 24, and 36 months|IP population||percentage of participants||95% Confidence Interval|Number
820490|NCT01144364|Primary|Percentage of Participants With Disease Progression or Death|PFS from randomization was measured from the date of randomization to the date of documented disease progression, relapse, or death from any cause. PFS function was estimated using Kaplan-Meier product-limit method. Responding participants and participants who were lost to follow up were censored at their last assessment date.|12, 24, and 34 months|ITT population||percentage of participants|||Number
820491|NCT01144403|Secondary|Number of Participant With Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with study treatment.|Up to 50 months (approximately)|Safety population included all the participants who had received at least one dose of study treatment.||participants|||Number
820492|NCT01144403|Secondary|Progression-free Survival (PFS)|PFS is defined as the interval between the day of enrollment and the first documentation of progressive disease or death. Progression of disease is defined as at least a 20 percent (%) increase in the sum of longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.|From the time of enrollment until death due to any cause (up to 50 months [approximately])|Efficacy population included all the participants who had received at least one dose of study treatment.||days||95% Confidence Interval|Median
820493|NCT01144403|Secondary|Overall Survival (OS)|Overall survival is defined as time from date of enrollment to the date of death, regardless of the cause of death.|From the time of enrollment until death due to any cause (up to 50 months [approximately])|Efficacy population included all the participants who had received at least one dose of study treatment.||days||95% Confidence Interval|Median
820494|NCT01144403|Primary|Overall Response Rate (ORR)|Overall Response Rate (ORR) was determined by tumor response according to International Workshop Group to Standardize Response Criteria for mantle cell lymphoma (MCL) criteria from confirmed evaluations of both target, radiographically evaluated, and non-target lesions. A responder is defined as a subject experiencing either a complete (CR)/ unconfirmed complete (Cru), or partial response (PR) by these criteria. As per criteria; CR = disappearance of all evidence of disease; CRu = the sum of the product of the diameters (SPD) of multiple nodes decreased by at least 75%; PR = regression of measurable disease and no new sites.|Up to 50 months (approximately)|Efficacy population included all the participants who had received at least one dose of study treatment.||percentage of participants|||Number
820500|NCT01144442|Primary|Feasibility of HIPC in Recurrent Disease Setting|We will determine feasibility based on the proportion of patients who complete 6 prescribed cycles of second line chemotherapy after undergoing the HIPC procedure.|6 months|||participants|||Number
820501|NCT01144442|Secondary|Overall Survival|Overall survival will be defined as time from date of surgery to date of death or censored at the date of last documented contact for patients still alive.|Up to 5 Years||||||
820502|NCT01144442|Secondary|Progression-free Survival|Disease progression will be defined as time from surgery to first of either an increase in CA125 from post-treatment value (to a value greater than 100 or doubling of nadir CA125 levels) or new/increasing measurable disease by CT scan as defined by RECIST criteria, (secondary recurrence) or censored at date of last contact for patients still alive and who have no progressed or recurred (from date of surgery to disease progression).|Up to 5 Years||||||
820503|NCT01144442|Secondary|Quality of Life Measurements|The quality of life measurements (version 4 of the FACT-O questionnaire) will be summed over each subscale and overall and comparisons will be made using t-tests at distinct visits.|Baseline, 6 Weeks Post Surgery, Every 3 Weeks Up to Week 27||||||
820504|NCT01144442|Primary|Clinical Response|We will summarize clinical response as the proportion of patients with complete response. Complete response will be defined as normalization of CA125. - After 6 cycles of Second Line Adjuvant Chemotherapy.|After 6 cycles of Paclitaxel & Carboplatin (Week 21 up to 27)|||participants|||Number
820505|NCT01144598|Secondary|Evaluation of Rheumatoid Arthritis Treatments Duration|Time elapsed from onset of symptoms to diagnosis of rheumatoid arthritis (that is, from the first rheumatoid arthritis-related symptoms to diagnosis by a related specialist) and the time elapsed from diagnosis with rheumatoid arthritis to initiation of anti-tumor necrosis factor (anti-TNF) treatment.|Day 1|All participants with available information were included in the analysis.||Months||Standard Deviation|Mean
820506|NCT01144598|Secondary|Number of Deformities at Inspection|The number of joint deformities of the study participants.|Day 1|All participants with available information were included in the analysis.||Participants|||Number
820507|NCT01144598|Secondary|Sedimentation Rate|The erythrocyte (red blood cell) sedimentation rates of study participants were assessed.|Day 1|All participants with available information were included in the analysis.||millimeters/hour||Standard Deviation|Mean
820513|NCT01144598|Secondary|Number of Disease Modifying Anti-Rheumatic Drugs|The number of disease-modifying anti-rheumatic drugs (DMARDs) that participants were taking to treat their rheumatoid arthritis.|Day 1|All participants with available information were included in the analysis.||Participants|||Number
820514|NCT01144598|Secondary|Evaluation of Visual Analog Scale (VAS) for Pain and Fatigue|Participants rated their pain and fatigue using a visual analog scale from 0 to 10, where 10 was the worst case.|Day 1|Participants who provided a visual analog scale rating for pain and fatigue were included in the analysis.||Units on a scale||Standard Deviation|Mean
820515|NCT01144598|Secondary|Evaluation of Disease Activity Score 28 (DAS28)|"The DAS28 index measures disease activity in rheumatoid arthritis and is derived from the number of swollen/tender joints, laboratory tests of inflammation, and participant assessment of global health (by marking a 100 mm line from very good to very bad). A higher score indicates worse control of disease. A DAS28 less than 3.2 indicates low disease activity and a DAS28 greater than 5.1 indicates high disease activity."|Day 1|All participants with available information were included in the analysis.||Participants|||Number
820516|NCT01144598|Secondary|Evaluation of Global Rheumatoid Arthritis Severity Scale|Global rheumatoid arthritis severity was assessed by asking the participants to consider all the ways their rheumatoid arthritis affected them and to rate how they were doing on a scale of 0 (very well) to 10 (very poor).|Day 1|All participants with available information were included in the analysis.||Units on a scale||Standard Deviation|Mean
820517|NCT01144598|Secondary|Work Limitation: Work Productivity and Activity Impairment (WPAI) Questionnaire|The WPAI evaluates the ability to work and perform regular activities. The scale yields 4 types of scores (range 0 to 100): Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Higher scores indicate impairment.|Day 1|All participants who completed the rating scales were included in the analysis.||Units on a scale||Standard Deviation|Mean
820518|NCT01144598|Secondary|Work Limitation: Health Assessment Questionnaire-Disability Index (HAQ-DI)|The HAQ-DI measures physical function by assessing the ability to perform daily living tasks. Each task is rated from 0 (no difficulty) to 3 (unable to do). The total score ranges from 0 to 3. Higher scores indicate impairment.|Day 1|All participants who completed the rating scales were included in the analysis.||Units on a scale||Standard Deviation|Mean
820519|NCT01144598|Primary|Evaluation of Disease Duration: Time From Diagnosis to Disease-Modifying Anti-Rheumatic Drug Treatment in Rheumatoid Arthritis|The time elapsed from diagnosis of rheumatoid arthritis to initiation of treatment with disease-modifying anti-rheumatic drugs (DMARDs).|Day 1|All participants with available information were included in the analysis.||Months||Standard Deviation|Mean
820520|NCT01144624|Secondary|Pharmacodynamic Effects of AZD9773 on TNF-alpha|TNF-alpha levels over approximately 6 days following the first dose|Levels taken at baseline, over the dosing period (up to Day 5/6)|Safety analysis set||pg/ml||Full Range|Median
820521|NCT01144624|Primary|Pharmacokinetics of AZD9773|Maximum concentration at steady state (Cmax ss) for serum total and specific fabs|From first dose to last dose (Day 5/6 or at premature treatment discontinuation)|Pharmacokinetic analysis set||ug/mL||Full Range|Geometric Mean
820522|NCT01144624|Primary|Safety and Tolerability of AZD9773|Number of patients with treatment-emergent adverse events and number of patients who died over 28 days|28 day study period|Safety analysis set||Participants|||Number
820523|NCT01144715|Secondary|Stroke Impact Scale (SIS)|Quality of Life changes are measured with the Stroke Impact Scale questionnaire. The SIS is a self-rated QOL questionnaire that addresses several domains following stroke: physical strength, memory, feelings and emotions, communication, activities of daily living (ADL), mobility, hand use, meaningful activities, and overall percentage recovery from the stroke. We report the Hand Function subscale, which ranges from 0-to-100. A higher score reflects better hand function.|End of treatment at 8 weeks post enrolment|||units on a scale||Standard Deviation|Mean
820524|NCT01144715|Secondary|Fugl-Meyer Upper Extremity Test|Upper Extremity neurological impairment will be measured using the Fugl-Meyer Upper Extremity Test (FMA). The FMA is an impairment-based measure consisting of 33 movements with higher scores indicating increased ability of the patient to move out of synergistic patterns toward more isolated movements. Movement quality of the affected UE is compared to the non-affected UE on 0–2 ordinal scale with 0 indicating no movement at all, 1 indicating partial movement of the affected extremity, and 2 indicating movement equivalent to the non-affected UEs. The score ranges from 0-to-66.|End of Treatment at 8 weeks post enrolment|||units on a scale||Standard Deviation|Mean
820525|NCT01144715|Secondary|Wolf Motor Function Test|The Wolf Motor Function Test (WMFT) is used to measure the degree of function using timed tasks. The WMFT is a 17-item measure used to assess activity limitations of the upper extremity. It is comprised of 2 strength items and 15 timed task performance items. The task performance items begin with the measurement of simple proximal movements and progress to more complex distal and whole limb movements. The WMFT yields two scores: 1) a functional ability score quantifying quality of performance, and 2) a timed score quantifying speed of performance in seconds. A shorter time is better outcome.|End of treatment at 8 weeks post enrolment|||Seconds||Standard Deviation|Geometric Mean
820526|NCT01144715|Primary|Action Research Arm Test (ARAT)|The amount of recovery of arm-hand function is measured with the Action Research Arm Test (ARAT). The ARAT assesses activity limitations of the upper extremity. It includes 19 items divided into four subscales: grasp, grip, pinch, and gross movement. Scores range from 0-to-57 with a higher score indicating a better outcome.|End of treatment at 8 weeks post enrolment|||units on a scale||Standard Deviation|Mean
820527|NCT01144949|Secondary|Time to Spontaneous Stone Passage (All Stones)|Time to stone passage for all ureteral stones (regardless of location) is assessed by entries in subject diaries.|4 weeks|ITT population||days||Standard Error|Mean
820528|NCT01144949|Primary|Spontaneous Stone Passage (All Stones) Without Need for Emergency Department Visits, Hospital Admissions, Surgical Intervention, or Other Interventional Procedures.|The primary efficacy variable is the occurrence of spontaneous stone passage within 4 weeks, as determined by radiography. For this outcome measure, analysis includes all ureteral stones, regardless of location in the ureter.|4 weeks|This endpoint analyzed all subjects in the ITT population, defined as randomized and received at least one dose of study drug (115 in the 8 mg silodosin arm, 117 in the placebo arm)||participants|||Number
820529|NCT01144949|Secondary|Change From Baseline in Average Score on the Brief Pain Inventory (Distal Stones)|At each study visit, subjects were given a Brief Pain Inventory (BPI) Questionnaire to complete. The BPI collects subject-reported pain severity scores and assesses impact of pain upon the subject’s daily life, on a 10-point scale (with 10 being the greatest severity/impact). Analysis was change from baseline to week 4.|4 weeks|Those subjects in the ITT population (defined as randomized and received at least one dose of study drug) with stones located in the distal ureter (determined by radiography) were included in this analysis. The number of ITT subjects with distal stones was 52/115 in the 8 mg silodosin treatment arm and 59/117 in the placebo treatment arm.||units on a scale||Standard Deviation|Mean
820530|NCT01144949|Secondary|Outpatient Narcotic Analgesic Use for Pain Relief|Narcotic analgesic use was assessed through a subject diary. Analysis was performed on the number of days with analgesic use.|4 weeks|ITT population||Days||Standard Deviation|Mean
820531|NCT01144949|Secondary|Time to Spontaneous Stone Passage (Distal Stones)|Time to stone passage for distally-located stones is assessed by entries in subject diaries.|4 weeks|Those subjects in the ITT population (defined as randomized and received at least one dose of study drug) with stones located in the distal ureter (determined by radiography) were included in this analysis. The number of ITT subjects with distal stones was 52/115 in the 8 mg silodosin treatment arm and 59/117 in the placebo treatment arm.||days||Standard Error|Mean
820532|NCT01144949|Primary|Spontaneous Stone Passage (Distal Stones) Without Need for Emergency Department Visits, Hospital Admissions, Surgical Intervention, or Other Interventional Procedures.|"The primary efficacy variable is the occurrence of spontaneous distal stone passage within 4 weeks, as determined by radiography.
For this outcome measure, analysis includes only those stones located in the distal ureter."|4 weeks|Those subjects in the ITT population (defined as randomized and received at least one dose of study drug) with stones located in the distal ureter (determined by radiography) were included in this analysis. The number of ITT subjects with distal stones was 52/115 in the 8 mg silodosin treatment arm and 59/117 in the placebo treatment arm.||participants|||Number
820533|NCT01145352|Secondary|Percentage of Participants With Overall Improvement On Physician's Assessment.|Percentage of participants in whom the efficacy of etanercept was assessed as either markedly effective or effective.|24 weeks|The efficacy analysis population consisted of the participants in whom DAS28 (4/ESR) was calculated (N = number of participants evaluated). The last observation carried forward (LOCF) method was used to impute missing data.||percent||95% Confidence Interval|Number
820534|NCT01145352|Primary|Percentage of Good Responders and Moderate Responders Among Participants With European League Against Rheumatism (EULAR) Response Based on DAS28|The Disease Activity Score Based on 28-joints Count based (DAS28-based) EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1.|24 weeks|The efficacy analysis population consisted of the participants in whom DAS28 (4/ESR) was calculated (N = number of participants evaluated). The last observation carried forward (LOCF) method was used to impute missing data.||Percentage of participants||95% Confidence Interval|Number
820535|NCT01145352|Primary|Number of Unlisted Treatment-Related Adverse Events of Etanercept|Adverse events are all unfavorable events, including clinically problematic abnormal changes in laboratory test values, which develop in participants after the administration of Etanercept, irrespective of causal relationship to Etanercept. The causal relationship between an adverse event and Etanercept was evaluated by the sponsor. Unlisted treatment-related adverse events were confirmed with listed adverse drug reactions specified in Japanese package insert.|24 weeks|The safety analysis population consisted of the participants who received 10 mg or 25 mg lyophilized etanercept (genetical recombination) for subcutaneous injection indicated for polyarticular JIA after the marketing authorization had been granted.||events|||Number
820536|NCT01145352|Primary|Number of Participants With Serious Treatment-Related Adverse Events of Etanercept|Serious treatment-related adverse events are defined as any events that lead to death, life-thretening, hospitalization or prolonged hospitalization, a permanent or remarkable disorder/dysfunction, congenital anormaly/congenital deficiency, or other medically significant events or disorder.|24 weeks|The safety analysis population consisted of the participants who received 10 mg or 25 mg lyophilized etanercept (genetical recombination) for subcutaneous injection indicated for polyarticular JIA after the marketing authorization had been granted.||participants|||Number
820537|NCT01145352|Primary|Number of Participants With Treatment-Related Adverse Events of Etanercept|Adverse events are all unfavorable events, including clinically problematic abnormal changes in laboratory test values, which develop in participants after the administration of Etanercept, irrespective of causal relationship to Etanercept. The causal relationship between an adverse event and Etanercept was evaluated by the sponsor.|24 weeks|The safety analysis population consisted of the participants who received 10 mg or 25 mg lyophilized etanercept (genetical recombination) for subcutaneous injection indicated for polyarticular JIA after the marketing authorization had been granted.||participants|||Number
820538|NCT01145391|Secondary|Clinical Inertia|"Definition of clinical inertia: failure of a primary care physician to initiate/intensify anti-hypertensive medications AND the failure to provide behavioral counseling to lower blood pressure during a clinic visit where blood pressure is elevated above 140/90 mm Hg. The clinical inertia measure is the percentage of clinic visits with clinical inertia present divided by the total number of clinic visits.
We report a change in group mean levels of clinical inertia from baseline to 9 months post-randomization. Negative values for clinical inertia represent a decrease in the percentage of clinic visits where clinical inertia was present. Pre-randomization clinical inertia was assessed in the last 2 clinic visits prior to randomization, and post-randomization inertia was assessed in the first 2 post-randomization visits.
Hypothesis: clinical inertia will be significantly greater in the usual care compared with intervention group in the post-randomization period."|Baseline, 9 months|||% visits with inertia present||95% Confidence Interval|Number
820568|NCT01145755|Primary|MADRS Total Score Change From Baseline to Week 6|Montgomery-Asberg Depression Rating Scale (MADRS): The MADRS is a 10-item scale for the evaluation of depressive symptoms (Montgomery et al 1979). Each MADRS item is rated on a 0 to 6 scale. Total score range from 0-60, where higher MADRS scores indicate higher levels of depressive symptoms.|6 weeks|||scores on the scale||Standard Deviation|Mean
820539|NCT01145391|Primary|Blood Pressure|Hypothesis: compared with patients who receive usual care, patients who receive intervention will have an average systolic blood pressure that is at least 5 points lower 9 months after randomization.|Baseline, 9 months|Intention-to-treat analyses using restricted maximum likelihood (REML) for a repeated measures model with incomplete data (SAS Proc Mixed). As this assumes that the occurrence of missing follow-up data depends only on observed data (i.e., pre-randomization values), we also performed a sensitivity analysis using the method proposed by Little.||mm Hg||95% Confidence Interval|Mean
820540|NCT01145417|Secondary|Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8)|PHQ-8: 8-item self-administered validated subset of PHQ-9, which comprises first 8 items of measure. Participant rated “Over past 2 weeks, how often bothered by any of following problems?”: little interest in doing things(1); feeling down(2); trouble falling or staying asleep/sleeping too much(3); feeling tired(4); poor appetite/overeating(5); feeling bad about self(6); trouble concentrating(7); moving or speaking slowly or being so fidgety/moving around more than usual(8). Each item scored on scale of 0(not at all)-3(nearly every day). Total score range: 0-24, higher score=greater severity.|Baseline|SAF population included all participants who signed the informed consent, had exposure to open label study drug and had at least one safety assessment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||participants|||Number
820541|NCT01145417|Secondary|Number of Participants With Response to Sheehan-Suicidality Tracking Scale (S-STS) Mapped to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories|S-STS:8-item clinician/participant administered prospective rating scale to assess TE suicidal(Su) ideation(ID),behavior(BHV).Items 1a,2-6,7a,8 scored on 5-point Likert scale 0(not at all) to 4(extremely). Items 1,1b,7 require yes/no response. S-STS total score range 0-30. Lower score=reduced Su tendency. Responses on S-STS were mapped to Columbia Classification Algorithm of Suicide Assessment(C-CASA) as 1:Completed Su; 2: Su attempt; 3: Preparatory acts; 4: Su ID; 5: Self-injurious (SI) BHV, intent unknown; 6: Not enough information; 7: SI BHV, no Su intent; 8: Other, no deliberate self harm.|Baseline up to Week 25|SAF included all participants who signed the informed consent, had exposure to open label study drug and had at least one safety assessment.||participants|||Number
820542|NCT01145417|Secondary|Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C)|PGI-C: participant rated instrument to measure participant's change in overall status since the start of the study, on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Number of participants in each category are reported.|Week 24|ITT population: all enrolled participants who had at least one dose of open label study drug. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||participants|||Number
820543|NCT01145417|Secondary|Visual Analogue Scale for Pain (VAS-pain)|Participants rated the severity of HIV neuropathy pain on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.|Baseline, Week 4, 8, 12, 16, 20, 24|ITT population: all enrolled participants who had at least one dose of open label study drug. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here ‘n’ signifies participants who were evaluable at specific time points for each arm group, respectively.||millimeter (mm)||Standard Deviation|Mean
820544|NCT01145417|Secondary|36-Item Short-Form Health Survey (SF-36)|SF-36 is a standardized survey evaluating 8 domains of functional health and well being: physical and social (So) functioning (Fn), physical and emotional role (role-physical [R-P], role-emotional [R-E]) limitations, bodily pain (BP), general health (GH), vitality (Vit), mental health (MnH). Two summary scores include Physical Component (Ph C) and Mental Component (Mn C). The score for a section is an average of the individual question scores. Score range for domain scores and summary scores: 0-100 (100=highest level of functioning).|Baseline, Week 24|ITT population included all enrolled participants who took at least one dose of open label study drug. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here ‘n’ signifies participants evaluable at given time point for specific parameter for each arm group, respectively.||Units on a scale||Standard Deviation|Mean
820545|NCT01145417|Secondary|Productivity and Activity Impairment Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire|WPAI: 6-question participant rated questionnaire to determine the degree to which SHP affected work productivity while at work and affected activities outside of work. It assesses amount of absenteeism, presenteeism and daily activity impairment attributable to a HIV neuropathy pain. Question 5 and 6 assesses: How much leg/foot pain affect productivity and daily activity, respectively in past 7 days? on 11-point scale, where 0 (not affected/no impairment) to 10 (completely affected/impaired).|Baseline, Week 24|ITT population: all enrolled participants who had at least one dose of open label study drug. 'N' (number of participants analyzed) signifies participants evaluable for this measure. Here ‘n’ signifies participants evaluable at given time point for specific question for each arm group, respectively.||Units on a scale||Standard Deviation|Mean
820546|NCT01145417|Secondary|Absenteeism and Presenteeism Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire|WPAI: 6-question participant rated questionnaire to determine the degree to which SHP affected work productivity while at work and affected activities outside of work. It assesses amount of absenteeism, presenteeism and daily activity impairment attributable to a HIV neuropathy pain. Question 2 and 3 assesses absenteeism as: Hours of work missed in past 7 days due to leg/foot pain or other reason, respectively. Question 4 assesses presenteeism as: Hours of work performed in past 7 days.|Baseline, Week 24|ITT population: all enrolled participants who had at least one dose of open label study drug. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here ‘n’ signifies participants evaluable at given time point for specific question for each arm group, respectively.||hours||Standard Deviation|Mean
820569|NCT01145898|Primary|3-year Change in OPP|Measurement of change in ocular perfusion pressure|Baseline and 36 month visits|||mm Hg||Standard Error|Mean
820570|NCT01145898|Primary|3-year Change in CRA RI|Measurement of change in ocular blood flow - central retinal arteries resistance index|Baseline and 36 month visits|||unitless||Standard Error|Mean
820571|NCT01145898|Primary|3-year Change in CRA EDV|Measurement of change in ocular blood flow - central retinal arteries end diastolic velocity|Baseline and 36 month visits|||cm/sec||Standard Error|Mean
820572|NCT01145898|Primary|3-year Change in CRA PSV|Measurement of change in ocular blood flow - central retinal arteries peak systolic velocity|Baseline and 36 month visits|||cm/sec||Standard Error|Mean
820547|NCT01145417|Secondary|Number of Participants Who Were Employed or Unemployed Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire|WPAI: 6-question participant rated questionnaire to determine the degree to which SHP affected work productivity while at work and affected activities outside of work. It assesses amount of absenteeism, presenteeism and daily activity impairment attributable to a Human Immunodeficiency Virus (HIV) neuropathy pain. Number of participants who responded “Yes/No” to Question 1: Are you currently employed (working for pay)? are reported.|Baseline, Week 24|Intent to Treat (ITT) population: all enrolled participants who had at least one dose of open label study drug. 'N' (number of participants analyzed) signifies participants evaluable for this measure. Here ‘n’ signifies participants evaluable at given time point for each arm group, respectively.||participants|||Number
820548|NCT01145417|Primary|Number of Participants With Treatment Emergent (TE) Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to 30 days after last dose of study treatment|Safety population (SAF) included all participants who signed the informed consent, had exposure to open label study drug and had at least one safety assessment.||participants|||Number
820549|NCT01145482|Secondary|Memory|Memory performance was assessed using delayed recall (number of units recalled) on the Wechsler Memory Scale (WMS-IV) logical memory (story recall) test. Scores represent a sum of recalled units of two different stories after a 30 minute delay. Total scores range from 0 to 50 (0-25 for each story) with higher scores reflecting better memory performance|15 minutes post insulin or placebo administration|||units on a scale||Standard Deviation|Mean
820550|NCT01145482|Primary|Cerebral Glutamate Concentration|Glutamate concentration was expressed as the ratio of glutamate to creatine. This was determined using magnetic resonance spectroscopy (MRS), a magnetic resonance technique that uses the same equipment as magnetic resonance imaging (MRI), but allows researchers to extract information about the concentrations of various neurochemicals of neurobiological significance.|15 minutes post insulin or placebo administration|per protocol||ratio||Standard Deviation|Mean
820551|NCT01145495|Secondary|Time to Best Response|Kaplan-Meier method will be used.|Up to 10 years||||||
820552|NCT01145495|Secondary|Time to Disease Progression|Kaplan-Meier method will be used.|Up to 10 years||||||
820553|NCT01145495|Secondary|Toxicity of Study Treatment, Assessed by the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0|Data will be summarized using frequency tables.|Up to 10 years||||||
820554|NCT01145495|Primary|Number of Participants Who Achieved a Complete Response|Response is assessed by investigator according to International Working Group (IWG) criteria. Complete response requires disappearance of all evidence of disease.|At 12 months|At the time of analysis, 54 participants had adequate to evaluate response.||participants|||Number
820555|NCT01145508|Primary|Overall Survival|Overall survival is defined as the time from randomization to death or the date of last known alive.|Assessed every 3 months for 2 years, and then every 6 months for 3 years|All randomized patients are included in the analysis.||Months||95% Confidence Interval|Median
820556|NCT01145547|Primary|Mean Area Under the Curve for Rise in Breakfast Post-prandial.|Arterialized blood glucose was monitored at 15 minute intervals and sensed glucose was recorded at five minute intervals. Mean area under the curve was calculated over the 3 hour period after breakfast for both the high and low glycemic breakfast meals.|Mean area under the curve was calculated at 0, 15min, 30 min, 45 min, 60min, 75 min, 90 min, 105 min, 120min, 135min, 150min, 165min and 180 min after breakfast|||min x (mmol/l)||Standard Deviation|Mean
820557|NCT01145560|Secondary|Safety and Tolerability|Number of patients with treatment-emergent adverse events|All study visits (over 90 days following first dose)|Safety Analysis Set||Participants|||Number
820558|NCT01145560|Secondary|28-day Mortality|Number of patients who died over 28 days|Over 28 days following first dose|Intention-to-treat analysis set||Participants|||Number
820559|NCT01145560|Secondary|7-day Mortality|Number of patients who died over 7 days|Over 7 days following first dose|Intention-to-treat analysis set||Participants|||Number
820560|NCT01145560|Primary|Ventilator-free Days (VFDs) Over 28 Days|Number of ventilator-free days (VFDs)|Over 28 days following first dose|Intention-to-treat analysis set||Days||Full Range|Median
820561|NCT01145625|Other Pre-specified|Target Area Hair Count (TAHC)|Number of hairs in the area being examined as measured by macrophotography.|Baseline to Week 52|Intent to Treat (ITT) population defined as all participants randomly assigned to a treatment group who received dispensed investigational product.||hairs per centimeter squared||Standard Deviation|Mean
820562|NCT01145625|Secondary|Target Area Hair Count (TAHC)|Number of hairs in the area being examined as measured by macrophotography|Baseline to Week 12|Intent-to-Treat (ITT) population defined as all participants randomly assigned to a treatment group who received dispensed investigational product.||hairs per centimeter squared||Standard Deviation|Mean
820563|NCT01145625|Primary|Target Area Hair Count (TAHC)|Number of hairs in the area being examined as measured by macrophotography.|Baseline to Week 24|Intent to Treat (ITT) population defined as all participants randomly assigned to a treatment group who received dispensed investigational product.||hairs per centimeter squared||Standard Deviation|Mean
820564|NCT01145638|Secondary|Change in Hemoglobin From Baseline to Week 24||24 weeks|The FAS population included all the subjects who were randomised into the study, received at least one dose of the study drug, and had at least one post-baseline Hb assessment. The subjects were considered as randomised, regardless of which treatment they actually received.||g/dL||Full Range|Mean
820565|NCT01145638|Primary|Change in Hb Concentration||Baseline week 4|The FAS population included all the subjects who were randomised into the study, received at least one dose of the study drug, and had at least one post-baseline Hb assessment. The subjects were considered as randomised, regardless of which treatment they actually received.||g/dL||Full Range|Mean
820566|NCT01145755|Secondary|MADRS Remission|A patient will be classified as in remission if their MADRS total score is ≤10 at Week 6|6 weeks|||Participants|||Number
820577|NCT01145898|Primary|6-month Change in Central Retinal Artery (CRA) Vascular Resistance (RI)|Measurement of change in ocular blood flow - central retinal arteries resistance index, this is a measure of the amount of resistance to blood flow within the selected blood vessel.|Baseline and 6 month visits|||unitless||Standard Error|Mean
820578|NCT01145898|Primary|6-month Change in Central Retinal Artery (CRA) End Diastolic Velocity (EDV)|Measurement of change in ocular blood flow - central retinal arteries end diastolic velocity|Baseline and 6 month visits|||cm/sec||Standard Error|Mean
820579|NCT01145898|Primary|6-month Change in Central Retinal Artery (CRA) Peak Systolic Velocity (PSV)|Measurement of change in ocular blood flow - central retinal arteries peak systolic velocity|Baseline and 6 month visits|||cm/sec||Standard Error|Mean
820580|NCT01145898|Primary|6-month Change in Ophthalmic Artery (OA) Vascular Resistance (RI)|Measurement of change in ocular blood flow - ophthalmic artery resistance index, this is a measure of the amount of resistance to blood flow within the selected blood vessel.|Baseline and 6 month visits|||unitless||Standard Error|Mean
820581|NCT01145898|Primary|6-month Change inOphthalmic Artery (OA) End Diastolic Velocity (EDV)|Measurement of change in ocular blood flow - ophthalmic artery end diastolic velocity|Baseline and 6 month visits|||cm/sec||Standard Error|Mean
820582|NCT01145898|Primary|6-month Change in Ophthalmic Artery (OA) Peak Systolic Velocity (PSV)|Measurement of change in ocular blood flow - ophthalmic artery peak systolic velocity|Baseline and 6 month visits|||cm/sec||Standard Error|Mean
820583|NCT01146054|Secondary|Proportion of Participants Achieving Freedom From Local Progression (FFLP) in Patients Treated With Gemcitabine Followed by Fractionated Stereotactic Body Radiotherapy (SBRT) for up to 5 Years of Follow up.|"Freedom from local progression is defined as the time from start of SBRT treatment to local progression, with death as a competing risk. If the patient neither died nor experienced local progression, then patient was censored at last follow up.
The data was analyzed in a competing risk model and the outcome reported was the 1 year cumulative incidence rate."|12/31/2012|||Proportion of participants with FFLP||95% Confidence Interval|Number
820584|NCT01146054|Secondary|To Determine the Overall Survival in Pancreatic Cancer Patients Treated With Gemcitabine and SBRT for up to 5 Years of Follow up.|Time to death was measured from start of treatment to until death. If death was not observed, the patient was censored at last follow up.|12/31/2012|The entire cohort.||Months||95% Confidence Interval|Median
820585|NCT01146054|Secondary|To Evaluate Progression Free Survival Following Gemcitabine and SBRT for up to 5 Years of Follow up .|"Time to progression free survival is measured from start of SBRT treatment until first progression event or death, which ever comes first. If the patient did not have an event, then the patient was censored at the last follow up.
The analysis was a Kaplan-Meier curve and the outcome was the median time to progression free survival."|12/31/2012|The whole cohort.||Months||95% Confidence Interval|Median
820586|NCT01146054|Secondary|Evaluate Acute Gastrointestinal Toxicity up to 3 Months of Treatment.|Acute grade 2 or greater gastritis, fistula, enteritis, or ulcer or any other grade 3-4 gastrointestinal toxicity within 3 months of treatment.|12/31/2012|Whole cohort.||Number of toxicities.|||Number
820587|NCT01146054|Primary|To Determine the Rate of (Grade 2 or Greater) Gastrointestinal Toxicity Attributable to Gemcitabine and Fractionated SBRT at One Year.|Grade 2 or greater late gastritis, fistula, enteritis, or ulcer or late grade 3-4 gastrointestinal toxicity at one year.|12/31/2012|The whole cohort was analyzed.||Number of toxicities.|||Number
820588|NCT01146275|Primary|To Evaluate the Long Term Safety of Macrolane in Breast Enhancement|"To evaluate the long term safety of Macrolane in breast enhancement, using relevant medical history, breast examination, mammography and ultrasound as well as a comprehensive MRI investigation.
Participants with AE/SAE since participation in study 31GB0106 or any findings at the breast examination, mammography, ultrasound or comprehensive MRI investigation"|7 years +/- 6 months post treatment|Subjects that participated in study 31GB0106 was asked to partícipate in the study 31GB0904. 6 subjects signed Informed consent for this study.||participants|||Number
820589|NCT01146275|Primary|To Evaluate if the Subject Has Macrolane Deposits in the Breast Seven Years Post Treatment, Using a Comprehensive MRI Investigation|The MRI investigation was performed to evaluate if the subjects has study product (Macrolane-a Hyaluronic acid) in their breast 7 years after the treatment.|7 years +/- 6months post treatment|MRI were performed by 4 women out of 6. One woman was pregnant and therefore not included and one did not want to perform MRI.||participants with remaining product|||Number
820590|NCT01146288|Primary|Renal Vascular Resistance (mm Hg/[ml/Min])||baseline and after diuretics administration|||mm Hg/[ml/min]||Standard Deviation|Mean
820591|NCT01146288|Primary|Change in GFR (ml/Min)||baseline and after diuretics administration|||ml/min||Standard Deviation|Mean
820592|NCT01146379|Primary|Change in Action Research Arm Test (ARAT) Score Per Week|The Action Research Arm Test (ARAT) is a standardized assessment of upper extremity functional capacity. Criterion scores are awarded by a trained assessor as the person performs 19 different items requiring reaching, grasping, and manipulation of various objects. Maximum total score is 57. Minimum total score is 0. Higher scores represent better arm and hand functional capacity. In this study, scores were assesses weekly and the analysis evaluated the rate of change over time in units/week.|9 weeks|||change in units on a scale/week||Standard Error|Mean
820593|NCT01146418|Secondary|Percentage of Participants With ≥1 Live Birth (Cumulative Live-Birth Rate)|The cumulative live-birth rate was defined as the number of participants with at least 1 live birth after ET in a COS cycle in Base Study P06029 or an FTET in Follow-Up Study P06031, divided by the total number of participants in each FAS treatment group.|From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to time of delivery (up to 2 years)|FAS population consisted of all randomized participants who received corifollitropin alfa or recFSH in Base Study P06029.||Percentage of Participants||95% Confidence Interval|Number
820606|NCT01146782|Secondary|Last Treatment Night Response (AHI Reduction)|Comparing AHI at the last treatment night to the control/baseline night is reported as the percent change in AHI. AHI is calculated by dividing the number of apnea/hypopnea events by the number of hours of sleep. AHI values are typically characterized as 5-15/hr = mild OSA, 15-30/hr = moderate OSA, and >30/hr = severe OSA. Negative numbers represent a decrease/improvement in AHI, whereas positive numbers represent an increase/no improvement in AHI.|At completion of 28 day home use.|All subjects in primary endpoint cohort with final evaluable treatment PSG.||AHI reduction (% change)||Inter-Quartile Range|Median
820594|NCT01146418|Primary|Percentage of Participants With ≥1 Vital Pregnancy (Cumulative Vital Pregnancy Rate)|The cumulative vital pregnancy rate was defined as the number of participants with at least 1 vital pregnancy in a controlled ovarian stimulation (COS) cycle in Base Study P06029 or a frozen-thawed embryo transfer (FTET) in Follow Up Study P06031, divided by the total number of participants in each Full Analysis Set (FAS) treatment group. A vital pregnancy was defined as an intrauterine pregnancy with fetal heart tones assessed at least 35 days (≥5 weeks) after embryo transfer (ET).|Assessed at least 35 days after ET in COS cycle in Base Study P06029 or an FTET cycle in Follow-Up Study P06031 (up to 2 years)|Full Analysis Set (FAS) population consisted of all randomized participants who received corifollitropin alfa or recFSH in Base Study P06029.||Percentage of Participants||95% Confidence Interval|Number
820595|NCT01146457|Primary|Rate of Breakthrough Pain|Rate of breakthrough pain is the number of episodes of breakthrough pain divided by the number of hours of labor. Time measured from placement of the neuraxial anesthetic, until delivery of the neonate. Because duration of labor is different for all patients, the rate of breakthrough pain per hour is used as the primary outcome.|Participants were followed for the duration of delivery, an average of 7 hours|||episodes of breakthrough pain per hour||Standard Deviation|Mean
820596|NCT01146600|Secondary|Reported Adverse Events||baseline, week 1, week 2||||||
820597|NCT01146600|Secondary|PSQI|"Scores on the Pittsburgh Sleep Quality Index (PSQI), a questionnaire based assessment of sleep quality. Scores were averaged by subject across all administrations for a given drug condition (i.e. administered twice on clarithromycin (once during week 1 and once during week 2) and twice on placebo (once during week 1 and once during week 2)).
Scores on the PSQI can range from 0 to 21. Higher scores indicate poorer sleep quality."|baseline, then after 1 week and 2 weeks on each study drug|Analysis was performed on all subjects who took both study drugs (i.e., clarithromycin and placebo)||units on a scale||Standard Deviation|Mean
820598|NCT01146600|Secondary|SF-36, Vitality Subscale|"The SF-36 is a health outcome scale with multiple subsections. Subjects were administered the entire SF-36; this analysis is of the vitality subscore provided by this scale. Scores were averaged by subject across all administrations for a given drug condition (i.e. administered once at baseline, twice on clarithromycin (once during week 1 and once during week 2) and twice on placebo (once during week 1 and once during week 2)).
The vitality subscore is calculated using four questions from the SF-36, and can range from 0 to 100. Higher scores reflect more vitality."|baseline, then after 1 week and 2 weeks on each study drug|Analysis was performed on all subjects who took both study drugs (i.e., clarithromycin and placebo)||units on a scale||Standard Deviation|Mean
820599|NCT01146600|Secondary|FOSQ|"Scores on the Functional Outcomes of Sleep Questionnaire (FOSQ) were averaged by subject across all administrations for a given drug condition (i.e. administered twice on clarithromycin (once during week 1 and once during week 2) and twice on placebo (once during week 1 and once during week 2)).
Scores on the FOSQ can range from 5 to 20. Higher FOSQ scores indicate less impairment due to sleepiness."|baseline, then after 1 week and 2 weeks on each study drug|Analysis was performed on all subjects who took both study drugs (i.e., clarithromycin and placebo)||units on a scale||Standard Deviation|Mean
820600|NCT01146600|Secondary|Epworth Sleepiness Scale|"Scores on the Epworth Sleepiness Scale (ESS) were averaged by subject across all administrations for a given drug condition (i.e. administered twice on clarithromycin (once during week 1 and once during week 2) and twice on placebo (once during week 1 and once during week 2)).
ESS scores can range from 0 to 24. Higher scores indicate higher levels of sleepiness."|baseline, then after 1 week and 2 weeks on each study drug|Analysis was performed on all subjects who took both study drugs (i.e., clarithromycin and placebo)||units on a scale||Standard Deviation|Mean
820601|NCT01146600|Secondary|PVT Number of Lapses|Number of lapses (no response for > 500 msec) on the PVT, averaged by subject across all administrations for a given drug condition (i.e. administered twice at baseline, four times on clarithromycin (twice during week 1 and twice during week 2), and four times on placebo (twice during week 1 and twice during week 2)). Higher numbers indicate worse vigilance.|baseline, then after 1 week and 2 weeks on each study drug|Analysis was performed on all subjects who took both study drugs (i.e., clarithromycin and placebo)||Number of lapses||Standard Deviation|Mean
820602|NCT01146600|Secondary|PVT Median Reaction Time at Week 1|"median reaction time on the PVT at week 1 of each intervention. Lower values reflect faster reaction times (i.e., better vigilance)
Note that the PVT provides a median of reaction times to all stimuli (~100) presented during the 10 minute PVT test. Each subject had two PVT tests at each visit, resulting in two median values. These were averaged, and then, for the purposes of this outcome, we then obtained the MEAN across multiple subjects for each condition (baseline, clarithromycin week 1, placebo week 1)"|week 1|Analysis was performed on all subjects who took both study drugs (i.e., clarithromycin and placebo)||Msec||Standard Deviation|Mean
820603|NCT01146600|Primary|Psychomotor Vigilance Task (PVT) Reaction Time|"Median reaction time on the PVT at the end of the second week of treatment. Lower values reflect faster reaction times (I.e., greater vigilance).
Note that the PVT provides a median of reaction times to all stimuli (~100) presented during the 10 minute PVT test. Each subject had two PVT tests at each visit, resulting in two median values. These were averaged, and then, for the purposes of this outcome, we then obtained the MEAN across multiple subjects for each condition (baseline, clarithromycin week 2, placebo week 2)"|week 2 of each intervention|Analysis was performed on all subjects who took both study drugs (i.e., clarithromycin and placebo)||Msec||Standard Deviation|Mean
820604|NCT01146613|Primary|Weekly Percentage of Heavy Drinking Days|Protocol: The primary outcome measure examines the hypothesis that varenicline will decrease the weekly proportion of heavy drinking days during Study Weeks 2 through 13 as compared to placebo.|Weeks 2-13*|||percentage of heavy drinking days||Standard Error|Mean
820605|NCT01146782|Secondary|Percent Reduction in Oxygen Desaturation Index (ODI)|Comparing first treatment night to control/baseline night reported as percent change. Negative numbers represent a reduction/improvement in ODI, whereas positive numbers represent increases/no improvement in ODI.|First treatment night|||ODI reduction (% change)||Inter-Quartile Range|Median
820607|NCT01146782|Secondary|Adverse Event Rate|Further categorized as serious and non-serious, device-related and non-device-related, unanticipated and anticipated, and based on level of severity. Adverse events will be evaluated during the trial at the following visits during 28-day take-home period: 7-day, 14-day, 21-day, 28-day follow-up, and any unscheduled visits.|4 weeks|The Safety Cohort consisted of all subjects who participated in at-home use of the device.||subjects|||Number
820608|NCT01146782|Primary|Clinical Success Defined as Apnea-hypopnea Index (AHI) Reduction of >50% and Treated AHI<20|Comparing first treatment night AHI to control/baseline night. AHI is calculated by dividing the number of apnea/hypopnea events by the number of hours of sleep. AHI values are typically characterized as 5-15/hr = mild OSA, 15-30/hr = moderate OSA, and >30/hr = severe OSA. For each subject, Clinical success was defined as apnea-hypopnea index (AHI) reduction of >50% and treated AHI<20. The number of subjects with clinical success was determined to calculate the primary endpoint as the ratio of the number of subjects with clinical success to the number of subjects.|first treatment night|All subjects in the primary endpoint cohort were analyzed.||subjects with clinical success|||Number
820609|NCT01146808|Secondary|Proportion of Patients Who Develop de Novo Hepatitis B Infection Post ADV Withdrawal, Which Will be Assessed at 6 Months Post Withdrawal||Six months after hepatitis B vaccination (2 years post transplant)|||Participants|||Count of Participants
820610|NCT01146808|Secondary|Proportion of Patients With a Sustained Hepatitis B Surface Antibody Titer > 500 IU/mL Prior to and After Vaccination||12-18 months post transplant|||Participants|||Count of Participants
820611|NCT01146808|Primary|Development of de Novo Hepatitis B Infection After Transplant With a Core Antibody Positive Liver|Determined by hepatitis B serologies and viral load.|Standard of care visits post-transplant for 2 years|||Participants|||Count of Participants
820612|NCT01146860|Secondary|Ultrasonography of Paranasal Sinuses|Percentage of patients with signs of acute rhinosinusitis in ultrasonography of paranasal sinuses will be evaluated. Ultrasonography scans will be visually evaluated by the investigator for signs of rhinosinusitis.|14 days|FAS: randomised patients with at least one documented application of the drug and post-baseline efficacy data||percentage of patients|||Number
820613|NCT01146860|Secondary|Percentage of Patients Classified as Responders by the Investigator on a 4-point Rating Scale|"General assessment of efficacy using a 4-point rating scale (symptoms healed, improved, unchanged, deteriorated). Patients whose symptoms are improved or healed will be classified as responders to treatment. Patients whose symptoms are unchanged or deteriorated as classified as non-responders."|14 days|FAS: randomised patients with at least one documented application of the drug and post-baseline efficacy data||percentage of patients|||Number
820614|NCT01146860|Secondary|Major Symptom Score Assessed by the Patient|"MSS: sum of the 5 main rhinosinusitis symptoms which are: rhinorrhea (anterior discharge), postnasal drip, nasal congestion, headache, facial pain/pressure.
Each symptom is individually evaluated using the following 4-point rating scale (scoring system): 0 = none/not present, 1 = mild, 2 = moderate, 3 = severe.
Thus the MSS ranges from a minimum of 0 to a maximum of 15 score points."|14 days|FAS: randomised patients with at least one documented application of the drug and post-baseline efficacy data||units on a scale||Standard Error|Mean
820615|NCT01146860|Secondary|SNOT 20 Symptom Scores|"Sino-Nasal Outcome Test (SNOT 20): 20 item questionnaire to assess the symptoms and emotional and social consequences of rhinosinusitis. The symptoms are assessed by the patient using a 6-point rating scale: 0 = not present / no problem, 1 = very mild problem, 2 = mild or slight problem, 3 = moderate problem, 4 = severe problem, 5 = problem as bad as it can be.
range: 0 to 100"|14 days|FAS: randomised patients with at least one documented application of the drug and post-baseline efficacy data||units on a scale (range: 0 - 100)||Standard Deviation|Mean
820616|NCT01146860|Primary|Major Symptom Score (MSS) Assessed by the Investigator|"MSS: sum of the 5 main rhinosinusitis symptoms which are: rhinorrhea (anterior discharge), postnasal drip, nasal congestion, headache, facial pain/pressure.
Each symptom is individually evaluated using the following 4-point rating scale (scoring system): 0 = none/not present, 1 = mild, 2 = moderate, 3 = severe.
Thus the MSS ranges from a minimum of 0 to a maximum of 15 score points."|14 days|FAS: randomised patients with at least one documented application of the drug and post-baseline efficacy data||units on a scale||Standard Error|Mean
820617|NCT01146873|Secondary|Highest Grade ALT After Randomization|Highest grade ALT after randomization. Grading was determined based on the Division of AIDS (2004) Toxicity Tables to grade adverse reactions. Grading scale: 0 (none), 1 (mild), 2 (moderate), 3 (severe), 4 (potentially life-threatening).|through 48 weeks post randomization|||number of participants|||Number
820618|NCT01146873|Secondary|Percentage of Participants With Elevated Total Cholesterol, Elevated LDL, Abnormal HDL, or Abnormal Triglycerides at 40 Weeks After Randomization|Percentage of participants with elevated total cholesterol, elevated LDL, abnormal HDL, or abnormal triglycerides at 40 weeks after randomization|40 weeks|||percentage of participants|||Number
820619|NCT01146873|Secondary|CD4 Cell Percentage at 48 Weeks After Randomization|CD4 Cell Percentage at 48 Weeks After Randomization|48 weeks|||percentage of cells||95% Confidence Interval|Mean
820620|NCT01146873|Primary|Viral Failure|Probability of viral failure defined as >= 2 HIV RNA measurements >1000 copies/ml using survival analysis by 48 weeks post-randomization.|48 weeks|||probability of viral failure||95% Confidence Interval|Mean
820621|NCT01146873|Primary|Viral Rebound|Probability of viral rebound defined as >=1 HIV RNA measurements >50 copies/ml using survival analysis by 48 weeks post-randomization.|48 weeks|||probability of viral rebound||95% Confidence Interval|Mean
820622|NCT01146912|Primary|Influenza Immunization: Delayed Pediatric|percentage of pediatric participants with influenza immunization by March 31 of 2012|March 31, 2012|||%participants vaccinated with influenza|||Number
820623|NCT01146912|Primary|Influenza Immunization: Pregnant Women|percentage of pregnant participants with influenza immunization by December 31, 2011|by December 31, 2011|||%participants vaccinated with influenza|||Number
820624|NCT01146912|Secondary|Attendance at Appointment|percentage of pregnant participants who attended an appointment a reminder for from Sept-December 2011|September-December 2011|||% participants attending appointment|||Number
820625|NCT01146912|Secondary|Pediatric: Vaccinated at Influenza Clinic|percentage of pediatric participants vaccinated at an influenza immunization clinic by March 31 of 2011|March 31, 2011|those unvaccinated by the start date for their cohort||% participant vaccinated at flu clinic|||Number
820626|NCT01146912|Primary|Influenza Immunization: Pediatric|percentage of pediatric participants with influenza immunization by March 31 of 2011|March 31, 2011|Individuals unvaccinated by time intervention start for their cohort||% participant vaccinated with influenza|||Number
820627|NCT01146951|Secondary|Clinical Global Impression of Change (CGIC)|"CGIC in participants with Lennox-Gastaut Syndrome (LGS) relative to placebo was presented as number of participants in each category at the final assessment (last observation carried forward [LOCF]) & at Week 12 of the Treatment Period. The investigator assessed the CGIC by comparing the participants' condition during the 4 weeks immediately before the completion (or discontinuation [d/c]) of the Treatment Period to his/her condition during the 4-week Observation Period (for participants who d/c'd the study during the Treatment Period, the CGIC was assessed by comparing the participant's condition from the start to discontinuation of the study treatment to his/her condition during the 4-week Observation Period).
The CGIC was assessed according to the following 7-grade scale based on the frequency & severity of seizures, AEs, and overall conditions of daily life.
Markedly improved, Improved, Slightly improved, Unchanged, Slightly worsened, Worsened, Markedly worsened."|Up to Week 12 of the treatment period|"Full analysis set (FAS) is defined as participants who were registered for the Treatment Period and excludes those listed below.
Participants who did not meet the inclusion criterion related the target disease, participants who did not take the study drug, participants without any evaluable efficacy data after the start of study treatment."||participants|||Number
820628|NCT01146951|Secondary|Percentage Change in the Frequency of Seizures Other Than Tonic-atonic Seizures (Per 28 Days)|"Percent change in the frequency of seizures other than tonic-atonic seizures (per 28 days) was calculated using the total seizure frequency per 28 days of the Observation Period as the baseline and the total seizure frequency per 28 days of the Treatment Period as the post-treatment value. Percentage change in total seizure frequency was calculated as follows: [100 x (post-treatment value - baseline)/ baseline].
Seizures analyzed other than tonic-atonic seizures included:
Partial seizure freq. (frequency), Absence seizure, Atyp. (atypical) absence seizure, Myoclonic seizure, Clonic seizure, Tonic seizure, Tonic-clonic seizure, Atonic seizure, & Uncla. (unclassified) epileptic seizure.
The frequency of epileptic seizures was recorded in the diary by the recorder. Seizure frequency was counted based on the classification established by the International League Against Epilepsy (ILAE). The diary recorder monitored the participant and recorded the seizure diary in a consistent manner."|Baseline (28 day observational period) and End of Treatment (28 day treatment period)|"Full analysis set (FAS) is defined as participants who were registered for the Treatment Period and excludes those listed below.
Participants who did not meet the inclusion criterion related the target disease, participants who did not take the study drug, participants without any evaluable efficacy data after the start of study treatment."||Percent change||Full Range|Median
820629|NCT01146951|Secondary|Percent Change in Total Seizure Frequency (Per 28 Days)|Percent change in the total seizure frequency (per 28 days) was calculated using the total seizure frequency per 28 days of the Observation Period as the baseline and the total seizure frequency per 28 days of the Treatment Period as the post-treatment value. Percentage change in total seizure frequency was calculated as follows: [100 x (post-treatment value - baseline)/ baseline].|Baseline (28 day observational period) and End of Treatment (28 day treatment period)|"Full analysis set (FAS) is defined as participants who were registered for the Treatment Period and excludes those listed below.
Participants who did not meet the inclusion criterion related the target disease, participants who did not take the study drug, participants without any evaluable efficacy data after the start of study treatment."||Percent Change||Full Range|Median
820630|NCT01146951|Secondary|Number of Participants Achieving a 50% Reduction in Tonic-atonic Seizure Frequency|50% Responder Rate in Tonic-Atonic Seizure Frequency was presented as the number of participants who achieved a 50% reduction in tonic-atonic seizure frequency.|12 weeks|"Full analysis set (FAS) is defined as participants who were registered for the Treatment Period and excludes those listed below.
Participants who did not meet the inclusion criterion related the target disease, participants who did not take the study drug, participants without any evaluable efficacy data after the start of study treatment."||Participants|||Number
820631|NCT01146951|Primary|Percent Change in Tonic-Atonic Seizure Frequency From Baseline (Per 28 Days)|"The sum of the frequencies of tonic seizures and atonic seizures was defined as the “tonic-atonic seizure frequency” and the percent change in tonic-atonic seizure frequency per 28 days was assessed. The percent change in tonic-atonic seizure frequency was calculated using the tonic-atonic seizure frequency per 28 days of the Observation Period as the baseline and the tonic-atonic seizure frequency per 28 days of the Treatment Period as the post-treatment value. Percentage change in tonic - atonic seizure frequency was calculated as follows: [100 x (post-treatment value - baseline)/ baseline].
The frequency of epileptic seizures was recorded in the seizure diary by the recorder. Seizure frequency was counted based on the classification established by the International League Against Epilepsy (ILAE). The diary recorder monitored the participant and recorded the seizure diary in a consistent manner, and continued these practices throughout the study period."|Baseline (28 day observational period) and End of Treatment (28 day treatment period)|"Full analysis set (FAS) is defined as participants who were registered for the Treatment Period and excludes those listed below.
Participants who did not meet the inclusion criterion related the target disease, participants who did not take the study drug, participants without any evaluable efficacy data after the start of study treatment."||Percent Change||Full Range|Median
820632|NCT01147042|Primary|Basal and PMA-stimulated O2 Production Detected by Ferricytochrome c Reduction in Neutrophils||21 weeks|Data were not collected.|||||
820633|NCT01147055|Secondary|Metabolite to Parent Ratio Maximum Observed Plasma Concentration (MRCmax)|Metabolite to parent molar ratio of maximum observed plasma concentration (MRCmax).|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and Day 0, 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 2|The PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||Ratio||Standard Deviation|Geometric Mean
820634|NCT01147055|Secondary|Metabolite to Parent Ratio Area Under the Curve From Time Zero to Extrapolated Infinite Time [MRAUC (0 - ∞)]|Molar ratio of metabolite to parent area under the curve from time zero to extrapolated infinite time [MRAUC (0-∞)].|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and Day 0, 0 (pre-dose) , 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 2|The PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||Ratio||Standard Deviation|Geometric Mean
820635|NCT01147055|Secondary|Metabolite to Parent Ratio Area Under the Curve From Time Zero to Last Quantifiable Concentration (MRAUClast)|Molar ratio of metabolite to parent area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (MRAUClast).|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and Day 0, 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 2|The PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||Ratio||Standard Deviation|Geometric Mean
820636|NCT01147055|Secondary|Maximum Observed Plasma Concentration (Cmax) for Crizotinib Metabolite (PF-06260182)||0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and Day 0, 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 2|The PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng/mL||Standard Deviation|Geometric Mean
820637|NCT01147055|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) for Crizotinib Metabolite (PF-06260182)||0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and Day 0, 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 2|The PK parameter analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||hr||Full Range|Median
820638|NCT01147055|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] for Crizotinib Metabolite (PF-06260182)|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞) of crizotinib metabolite (PF-06260182). It is obtained from AUC (0 - t) plus AUC (t - ∞).|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and Day 0, 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 2|The PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng*hr/mL||Standard Deviation|Geometric Mean
820639|NCT01147055|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Crizotinib Metabolite (PF-06260182)|Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast) of crizotinib metabolite (PF-06260182).|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and Day 0, 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 2|The PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng*hr/mL||Standard Deviation|Geometric Mean
820640|NCT01147055|Secondary|Apparent Volume of Distribution (Vz/F)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and Day 0, 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 2|The PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||L||Standard Deviation|Geometric Mean
820641|NCT01147055|Secondary|Apparent Oral Clearance (CL/F)|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body. Clearance obtained after oral dose CL/F is influenced by the fraction of the dose absorbed.|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and Day 0, 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 2|The PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||L/hr||Standard Deviation|Geometric Mean
820642|NCT01147055|Secondary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and Day 0, 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 2|The PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||hr||Standard Deviation|Mean
820643|NCT01147055|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and Day 0, 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 2|The PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||hr||Full Range|Median
820644|NCT01147055|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast).|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and Day 0, 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 2|The PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng*hr/mL||Standard Deviation|Geometric Mean
820645|NCT01147055|Primary|Maximum Observed Plasma Concentration (Cmax)||0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and Day 0, 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 2|The PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng/mL||Standard Deviation|Geometric Mean
820695|NCT01147406|Secondary|Maximum N6022 and Metabolite Concentrations in Plasma Within 24 Hours of End of Administration|Concentrations of N6022 and metabolite [N61149)], collected on Days 1 and 7; predose, end of infusion, and at 10 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 16, and 24 hours post-dose (the 24 hour postdose collected prior to the start of infusion on Day 2).|24 hours|Any subject that received the active IMP or placebo||ng/mL||Geometric Coefficient of Variation|Geometric Mean
820646|NCT01147055|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hours (hrs) post crizotinib dose in period 1 and Day 0, 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 2|The pharmacokinetic (PK) parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng*hr/mL||Standard Deviation|Geometric Mean
820647|NCT01147068|Secondary|Serologic Response Rates at Day 21 Using PanBlok With and Without Adjuvant and Placebo in Healthy Adults 18-64 Years of Age|Immunogenicity was assessed by measuring the seroconversion rates of subjects from Day 0 to Day 21 to determine and evaluate the immune response following a single dose of study vaccine. The results were compared using PanBlok with and without adjuvant and placebo in healthy adults|21 Days|All randomized subjects with Day 0 and Day 21 data analyzed by Cincinnati Children's Hospital Medical Center using the intent to treat population and CBER antigen.||percentage of participants||95% Confidence Interval|Number
820648|NCT01147068|Secondary|Evaluation and Comparison of Immunogenicity From Geometric Mean Titers of PanBlok With and Without Adjuvant and Placebo in Healthy Adults 18-64 Years of Age.|Immunogenicity was assessed by measuring the proportion of subjects that exhibited a geometric mean titer change from Day 0 to Day 42. The geometric mean titers from the PanBlok groups (with and without adjuvant)and placebo group were then compared.|Day 0, and Day 42|All randomized subjects who received study vaccine and had Day 0 and Day 42 geometric mean titers. Analysis of results were generated by Southern Research Institute on the overall population using whole virus.||titer||95% Confidence Interval|Geometric Mean
820649|NCT01147068|Primary|Evaluation of Immunogenicity Measured by Seroconversion Rates of PanBlok With and Without Adjuvant Compared to Placebo in Healthy Adults 18-49 Years of Age.|Immunogenicity was assessed by measuring the percentage of subjects in each group exhibiting seroconversion on Day 42. The treatment groups that received adjuvanted rHA were evaluated against non-adjuvanted rHA and placebo groups for whether they demonstrated seroconversion rates and 95% confidence intervals that met regulatory criterion for licensure.|42 Days|All randomized subjects who received study vaccine and had Day 0 and Day 42 efficacy data. The analysis results are generated by Southern Research Institute on the intention to treat efficacy population using whole virus.||percentage of participants||95% Confidence Interval|Number
820658|NCT01147250|Secondary|Percent Change From Baseline in the Urinary Albumin/Creatinine Ratio (UACR) at Week 108|Presence of albumin in urine is a marker of nephropathy, an important microvascular complication of diabetes. UACR was defined as the ratio: mg of albumin per gram of creatinine. UACR data were log transformed before the analysis. Calculation was based on geometric mean.|Baseline to Week 108 (LOCF)|ITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline UACR value. Missing data was imputed using last observation carried forward (LOCF) using the last available post-baseline UACR before Week 108 as the value at Week 108, regardless of treatment discontinuation or not.||percent change||Standard Error|Geometric Mean
820659|NCT01147250|Secondary|Time to First Occurence of CV Event: CV Death, Non-Fatal MI, Non-Fatal Stroke, Hospitalization for Unstable Angina, Hospitalization For Heart Failure or Coronary Revascularization Procedure|All CV events were positively adjudicated by CAC, used in the analysis of the composite CV endpoint comprised of CV death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina, hospitalization for heart failure, or coronary revascularization procedure. Number of observed participants with endpoint events were reported.|From randomization up to the end of study (median follow-up of 25 months)|ITT population.||participants|||Number
820660|NCT01147250|Secondary|Time to First Occurence of CV Event: CV Death, Non-Fatal MI, Non-Fatal Stroke, Hospitalization for Unstable Angina or Hospitalization For Heart Failure|All CV events were positively adjudicated by the CAC, used in the analysis of the composite CV endpoint comprised of CV death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina or hospitalization for heart failure. Number of observed participants with endpoint events were reported.|From randomization up to the end of study (median follow-up of 25 months)|ITT population.||participants|||Number
820661|NCT01147250|Primary|Time to First Occurence of Primary CV Event: CV Death, Non-Fatal MI, Non-Fatal Stroke or Hospitalization for Unstable Angina|Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the onset of primary CV endpoint over time. Number of observed participants with endpoint events were reported. A CV event adjudication committee (CAC) reviewed and adjudicated, in a blinded fashion, all potential events.|From randomization up to the end of study (median follow-up of 25 months)|Intent-to-treat (ITT) population defined as all randomized participants analyzed according to the treatment group allocated at randomization.||participants|||Number
820662|NCT01147302|Secondary|Area Under The Concentration-Time Curve (AUC) of C1 INH Functional Activity|Plasma samples were used for the determination of functional C1 INH parameters. Primary pharmacokinetic (PK) parameters were calculated using baseline-corrected concentration-versus-time data following the last dose and noncompartmental techniques, as appropriate. The following PK parameters were calculated: baseline concentration (Cbaseline), maximum concentration (Cmax), average concentration at steady-state (Cav,ss), time to maximum concentration (tmax), minimum concentration (Cmin), and area under the concentration-time curve from time zero to last quantifiable concentration at time t (AUC0-t). Blood was collected on Day 13 at the indicated timepoints. If plasmapheresis was performed on a dosing day, blood samples were obtained before plasmapheresis, prior to study drug administration (post-plasmapheresis), and at time points relative to the start of infusion.|Day 13 pre-plasmapheresis (if performed) and pre-dose then 0.5, 2, 24, 48, 96, 168 and 288 (optional) hours post start of infusion|The ITT-S population, defined as participants who received at least 1 dose (or any portion of a dose) of study drug (CINRYZE or placebo).||Units*h/mL||Standard Deviation|Mean
820663|NCT01147302|Secondary|Area Under The Concentration-Time Curve (AUC) of C1 INH Antigen|Plasma samples were used for the determination of antigenic C1 INH parameters. Primary pharmacokinetic (PK) parameters were calculated using baseline-corrected concentration-versus-time data following the last dose and noncompartmental techniques, as appropriate. The following PK parameters were calculated: baseline concentration (Cbaseline), maximum concentration (Cmax), average concentration at steady-state (Cav,ss), time to maximum concentration (tmax), minimum concentration (Cmin), and area under the concentration-time curve from time zero to last quantifiable concentration at time t (AUC0-t). Blood was collected on Day 13 at the indicated timepoints. If plasmapheresis was performed on a dosing day, blood samples were obtained before plasmapheresis, prior to study drug administration (post-plasmapheresis), and at time points relative to the start of infusion.|Day 13 pre-plasmapheresis (if performed) and pre-dose then 0.5, 2, 24, 48, 96, 168 and 288 (optional) hours post start of infusion|The ITT-S population, defined as participants who received at least 1 dose (or any portion of a dose) of study drug (CINRYZE or placebo).||g*h/L||Standard Deviation|Mean
820664|NCT01147302|Secondary|Time to Maximum Plasma Concentration (Tmax) of C1 INH|Plasma samples were used for the determination of antigenic and functional C1 INH concentrations. Primary pharmacokinetic (PK) parameters were calculated using baseline-corrected concentration-versus-time data following the last dose and noncompartmental techniques, as appropriate. The following PK parameters were calculated: baseline concentration (Cbaseline), maximum concentration (Cmax), average concentration at steady-state (Cav,ss), time to maximum concentration (tmax), minimum concentration (Cmin), area under the concentration-time curve from time zero to last quantifiable concentration at time t (AUC0-t). Blood was collected on Day 13 at the indicated timepoints. If plasmapheresis was performed on a dosing day, blood samples were obtained before plasmapheresis, prior to study drug administration (post-plasmapheresis), and at time points relative to the start of infusion.|Day 13 pre-plasmapheresis (if performed) and pre-dose then 0.5, 2, 24, 48, 96, 168 and 288 (optional) hours post start of infusion|The ITT-S population, defined as participants who received at least 1 dose (or any portion of a dose) of study drug (CINRYZE or placebo).||hours||Full Range|Median
820665|NCT01147302|Secondary|Serum Concentrations of C1 INH Functional Activity|Plasma samples were used for the determination of functional C1 INH concentrations. Primary pharmacokinetic (PK) parameters were calculated using baseline-corrected concentration-versus-time data following the last dose and noncompartmental techniques, as appropriate. The following PK parameters were calculated: baseline concentration (Cbaseline), maximum concentration (Cmax), average concentration at steady-state (Cav,ss), time to maximum concentration (tmax), minimum concentration (Cmin), area under the concentration-time curve from time zero to last quantifiable concentration at time t (AUC0-t). Blood was collected on Day 13 at the indicated timepoints. If plasmapheresis was performed on a dosing day, blood samples were obtained before plasmapheresis, prior to study drug administration (post-plasmapheresis), and at time points relative to the start of infusion.|Day 13 pre-plasmapheresis (if performed) and pre-dose then 0.5, 2, 24, 48, 96, 168 and 288 (optional) hours post start of infusion|The ITT-S population, defined as participants who received at least 1 dose (or any portion of a dose) of study drug (CINRYZE or placebo).||Units/mL||Standard Deviation|Mean
820666|NCT01147302|Secondary|Serum Concentrations of C1 Inhibitor (C1 INH) Antigen|Plasma samples were used for the determination of antigenic C1 INH concentrations. Primary pharmacokinetic (PK) parameters were calculated using baseline-corrected concentration-versus-time data following the last dose and noncompartmental techniques, as appropriate. The following PK parameters were calculated: baseline concentration (Cbaseline), maximum concentration (Cmax), average concentration at steady-state (Cav,ss), time to maximum concentration (tmax), minimum concentration (Cmin), area under the concentration-time curve from time zero to last quantifiable concentration at time t (AUC0-t). Blood was collected on Day 13 at the indicated timepoints. If plasmapheresis was performed on a dosing day, blood samples were obtained before plasmapheresis, prior to study drug administration (post-plasmapheresis), and at time points relative to the start of infusion.|Day 13 pre-plasmapheresis (if performed) and pre-dose then 0.5, 2, 24, 48, 96, 168 and 288 (optional) hours post start of infusion|||g/L||Standard Deviation|Mean
820667|NCT01147302|Secondary|Number of Participants With Allograft Failure|Allograft failure was determined by the presence of the following criteria: current renal allograft nephrectomy and/or a clinical determination that the allograft irreversibly and irrevocably ceased functioning.|From the day of enrollment to Day 90|The ITT-S population, defined as participants who received at least 1 dose (or any portion of a dose) of study drug (CINRYZE or placebo).||participants|||Number
820668|NCT01147302|Secondary|Number of Deaths||From Day 1 to Day 90|The ITT-S population, defined as participants who received at least 1 dose (or any portion of a dose) of study drug (CINRYZE or placebo).||participants|||Number
820669|NCT01147302|Secondary|Number of Participants Who Required Salvage Splenectomy|If necessary, rescue therapy included splenectomy.|From Day 1 to Day 90|The ITT-S population, defined as participants who received at least 1 dose (or any portion of a dose) of study drug (CINRYZE or placebo).||participants|||Number
820696|NCT01147406|Primary|Safety and Tolerability of a Single Ascending Doses of Intravenous N6022 in Healthy Volunteers|Safety variables - number of adverse events reported during study, changes in vital signs, physical examination findings, telemetry alerts, 12-lead ECG changes, infusion site reactions, O2 saturation changes, and clinical laboratory assessment changes between subjects receiving N6022 versus placebo.|7 Days|Any subject that received active IMP or placebo||Adverse Events|||Number
820670|NCT01147302|Secondary|Number of Plasmapheresis Sessions|If necessary, rescue therapy included plasmapheresis. Participating centers used plasmapheresis for desensitization, if necessary, prior to transplant and also for the treatment of acute AMR. Plasmapheresis therapy was performed for the qualifying episode of AMR according to standards at the investigational site and at the discretion of the investigator. Sessions include those prior to first dose. If plasmapheresis therapy occurred on the same day as study drug dosing, study drug was administered after completion of the plasmapheresis session.|From Day 1 through Days 20 and 90|The ITT-S population, defined as participants who received at least 1 dose (or any portion of a dose) of study drug (CINRYZE or placebo).||sessions||Standard Deviation|Mean
820671|NCT01147302|Secondary|Change From Baseline in Creatinine Clearance|Graft function was assessed by measuring creatinine clearance. Creatinine clearance was calculated by the Cockcroft-Gault formula. Baseline was the last value collected prior to first dose of study drug. A positive change from baseline indicates that the clearance rate has increased. Values for Day 90 were collected +/= 14 days.|From Day 1 to Days 20 and 90|The ITT-S population, defined as participants who received at least 1 dose (or any portion of a dose) of study drug (CINRYZE or placebo).||mL/min||Standard Deviation|Mean
820672|NCT01147302|Secondary|Change From Baseline in Serum Creatinine|Graft function was assessed by measuring serum creatinine. Serum creatinine level was obtained directly from laboratory results. Baseline was the last value collected prior to first dose of study drug. A negative change from baseline indicates that serum creatinine levels have decreased. Values for Day 90 were collected +/= 14 days.|From Day 1 to Days 20 and 90|The ITT-S population, defined as participants who received at least 1 dose (or any portion of a dose) of study drug (CINRYZE or placebo).||mg/dL||Standard Deviation|Mean
820673|NCT01147302|Primary|Change From Baseline in Histopathology Endpoints|The protocol-specified Day 20 (post-treatment) biopsy was compared to the qualifying biopsy to assess changes in histopathology for light and immunofluorescence microscopy. The Central Pathologist provided the following categorical information from the qualifying biopsy in an AMR Scorecard: C4d Score (0-100), Margination Score (0-100) Glomerulitis Score (0-100), Vasculitis Score (0-100), Glomerulosclerosis Score (0-100), Chronic Glomerulopathy Score (0-100), Interstitial Fibrosis Score (0-100), and the Chronic Vasculitis Score (0-100), with 0 being absence of abnormal histopathology. The “qualifying” renal allograft biopsy was performed as standard of care (SOC) within 12 months after transplant and prior to screening for this study. The first dose of study drug (Day 1) was administered within 72 hours after qualifying biopsy. A negative change from baseline indicates that histopathology has improved. Endpoint includes subjects with both Qualifying and Day 20 Biopsies.|Within 72 hours prior to first dose of study drug, Day 20|The ITT-S population, defined as participants who received at least 1 dose (or any portion of a dose) of study drug (CINRYZE or placebo).||scores on a scale||Standard Deviation|Mean
820674|NCT01147302|Secondary|Number of Participants With Resolution of The Qualifying Episode of Antibody-Mediated Rejection (AMR)|The “qualifying” renal allograft biopsy was performed as standard of care within 12 months after transplant and prior to screening. The qualifying biopsy was used to establish the diagnosis of AMR and was evaluated for all of the following to obtain baseline assessments: the presence of C4d, and monocyte or neutrophil infiltration around the peritubular capillaries (PTCs) and/or glomeruli. The Central Pathologist provided the following information from the qualifying biopsy in an AMR Scorecard: C4d Score, Glomerulitis Score, Vasculitis Score, Glomerulosclerosis Score, Chronic Glomerulopathy Score, Interstitial Fibrosis Score, and the Chronic Vasculitis Score. The Banff AMR Scoring System was used to summarize these scores. Resolution determination was made based on clinical criteria (improvement of serum creatinine ± decrease of DSA titer, and/or increase in urine output) and histopathology. The first dose of study drug (Day 1) was administered within 72 hours after qualifying biopsy.|90 days after start of treatment|The Intent-to-Treat Safety (ITT-S) population, defined as participants who received at least 1 dose (or any portion of a dose) of study drug (CINRYZE or placebo).||participants|||Number
820675|NCT01147341|Other Pre-specified|Proportion of Subjects Achieving a CDAI Score Decrease Greater Than or Equal to 13.9 Points in the CimZia Treatment Group Compared to the Placebo Group at Week 24|The Clinical Disease Activity (CDAI)is a composite score. Clinical Disease Activity (CDAI) = SJC(28): Swollen 28-Joint Count (shoulders, elbows, wrists, MCPs, PIPs (including thumb IP)+ TJC(28): Tender 28-Joint Count (shoulders, elbows, wrists, MCPs, PIPs (including thumb IP)+ PGA: Patient Global disease Activity (patient’s self assessment of overall RA disease activity on a scale 1-10 where 10 is maximal activity)+ EGA: Evaluator’s Global disease Activity (evaluator’s assessment of overall RA disease activity on a scale 1-10 where 10 is maximal activity) Remission: CDAI ≤ 2.8; Low Disease Activity: CDAI > 2.8 and ≤ 10 ;Moderate Disease Activity: CDAI > 10 and ≤ 22; High Disease Activity: CDAI > 22. A CDAI reduction of 6.5 represents moderate improvement.|Baseline to Week 24|30 subjects were included in the efficacy assessment as week 24. Subjects completed 24 weeks dosing including a 12 week open-label phase.||participants|||Number
820676|NCT01147341|Other Pre-specified|Proportion of Subjects Achieving a EULAR Good or Moderate Response Criteria in the Cimzia Treatment Group Compared to the Placebo Group|"The EULAR (European League Against Rheumatism) response criteria is a classified response criteria which classifies the patients individual as non-, moderate or good responders dependent on the change and the level of the Disease Activity Score.
The Disease Activity Score(DAS28) is a continuous disease measure composite of 4 variables: 28 tender joint count, 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. High disease activity= > 5.1, low disease activity= < 3.2, and remission= < 2.6. Clinically significant response= decrease of >1.2 from baseline. Utilizing EULAR response criteria, DAS28 categorical responses define a good (absolute: <3.2 or >1.2 improvement from baseline), moderate (absolute: 3.2-5.1 or 0.6-1.2 change from baseline), or no response (absolute: >5.1 or <0.6 change from baseline)."|Baseline to Week 24|30 subjects were included in the efficacy assessment as week 24. Subjects completed 24 weeks dosing including a 12 week open-label phase.||participants|||Number
820697|NCT01147458|Secondary|Urinary Leukotriene E4 (LTE4) Levels|LTE4 is a terminal metabolic product of arachidonic acid by 5-LO. Its synthesis is dependent upon the activity of 5-LO and it is eliminated through urinary clearance. Hence, the level of urinary LTE4 (uLTE4) excretion may be an indicator of endogenous 5-LO activity.|Day -7 (Visit 2) up to Day 43 (Visit 9 or End of Treatment Period 2)|Since the study was terminated prematurely for a potential safety signal, and in light of the efficacy analysis, the pharmacodynamic (PD) assessment of uLTE4 was not performed and no data are reportable.|||||
820677|NCT01147341|Other Pre-specified|Proportion of Subjects Achieving an American College of Rheuamtology Low Disease Activity Score and/or Remission Score in the Cimzia Group Compared to the Placebo Group as Calculated by DAS28 (CRP)|"The Disease Activity Score-28-C-reactive Protein (DAS28-CRP)is a composite measure for rheumatoid arthritis (RA) is based on 4 variables: tender and swollen joint counts (28 joints),C-Reactive Protein(CRP), and patient global assessment visual analog scale. A lower score indicated less disease activity.
Remission: CDAI ≤ 2.8; Low Disease Activity: CDAI > 2.8 and ≤ 10 ;Moderate Disease Activity: CDAI > 10 and ≤ 22; High Disease Activity: CDAI > 22"|Baseline to Week 24|30 subjects were included in the efficacy assessment as week 24. Subjects completed 24 weeks dosing including a 12 week open-label phase.||participants|||Number
820678|NCT01147341|Other Pre-specified|Proportion of Subjects Achieving an American College of Rheumatology 50% (ACR50) Response Criteria in the Cimzia Treatment Group Compared to the Placebo Group|"ACR50 responders are subjects with at least 50% improvement from baseline for tender joint cout (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale.
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do.
Visual Analog Scale (VAS) - assessment of arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad."|Baseline to Week 24|30 subjects were included in the efficacy assessment as week 24. Subjects completed 24 weeks dosing including a 12 week open-label phase.||participants|||Number
820679|NCT01147341|Other Pre-specified|Proportion of Subjects Achieving an American College of Rheumatology 20% (ACR20) Response Criteria in the Cimzia Treatment Group Compared to the Placebo Group|"ACR20 responders are subjects with at least 20% improvement from baseline for tender joint cout (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale.
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do.
Visual Analog Scale (VAS) - assessment of arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad."|Baseline to Week 24|30 subjects were included in the efficacy assessment as week 24. Subjects completed 24 weeks dosing including a 12 week open-label phase.||participants|||Number
820680|NCT01147341|Other Pre-specified|Proportion of Subjects Achieving a CDAI Decrease of Greater Than or Equal to 10 Points in the Cimzia Treatment Group Compared to the Placebo Group at Week 24|The Clinical Disease Activity (CDAI)is a composite score. Clinical Disease Activity (CDAI) = SJC(28): Swollen 28-Joint Count (shoulders, elbows, wrists, MCPs, PIPs (including thumb IP)+ TJC(28): Tender 28-Joint Count (shoulders, elbows, wrists, MCPs, PIPs (including thumb IP)+ PGA: Patient Global disease Activity (patient’s self assessment of overall RA disease activity on a scale 0-10 where 10 is maximal activity)+ EGA: Evaluator’s Global disease Activity (evaluator’s assessment of overall RA disease activity on a scale 0-10 where 10 is maximal activity) Remission: CDAI ≤ 2.8; Low Disease Activity: CDAI > 2.8 and ≤ 10 ;Moderate Disease Activity: CDAI > 10 and ≤ 22; High Disease Activity: CDAI > 22. A CDAI reduction of 6.5 represents moderate improvement.|Baseline to Week 24|30 subjects were included in the efficacy assessment as week 24. Subjects completed 24 weeks dosing including a 12 week open-label phase.||participants|||Number
820681|NCT01147341|Secondary|Proportion of Subjects Achieving a CDAI Score Decrease Greater Than or Equal to 13.9 Points in the CimZia Treatment Group Compared to the Placebo Group at Week 12|The Clinical Disease Activity (CDAI)is a composite score. Clinical Disease Activity (CDAI) = SJC(28): Swollen 28-Joint Count (shoulders, elbows, wrists, MCPs, PIPs (including thumb IP)+ TJC(28): Tender 28-Joint Count (shoulders, elbows, wrists, MCPs, PIPs (including thumb IP)+ PGA: Patient Global disease Activity (patient’s self assessment of overall RA disease activity on a scale 0-10 where 10 is maximal activity)+ EGA: Evaluator’s Global disease Activity (evaluator’s assessment of overall RA disease activity on a scale 0-10 where 10 is maximal activity) Remission: CDAI ≤ 2.8; Low Disease Activity: CDAI > 2.8 and ≤ 10 ;Moderate Disease Activity: CDAI > 10 and ≤ 22; High Disease Activity: CDAI > 22. A CDAI reduction of 6.5 represents moderate improvement..|Baseline to week 12|||participants|||Number
820682|NCT01147341|Secondary|Proportion of Subjects Achieving a EULAR Good or Moderate Response Criteria in the Cimzia Treatment Group Compared to the Placebo Group|"The EULAR (European League Against Rheumatism) response criteria is a classified response criteria which classifies the patients individual as non-, moderate or good responders dependent on the change and the level of the Disease Activity Score.
The Disease Activity Score(DAS28) is a continuous disease measure composite of 4 variables: 28 tender joint count, 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. High disease activity= > 5.1, low disease activity= < 3.2, and remission= < 2.6. Clinically significant response= decrease of >1.2 from baseline. Utilizing EULAR response criteria, DAS28 categorical responses define a good (absolute: <3.2 or >1.2 improvement from baseline), moderate (absolute: 3.2-5.1 or 0.6-1.2 change from baseline), or no response (absolute: >5.1 or <0.6 change from baseline)."|Baseline to week 12|||participants|||Number
820698|NCT01147458|Secondary|Plasma Concentration of PF-04191834||Pre-dose and post-dose (1 to 3 hours) on Days 1, 8, 15, 29, 36, and 43|Due to early termination of the study, only a subset of pharmacokinetic (PK) samples, from 10 out of 190 randomized participants, were selected for analysis. These 10 participants were selected based on treatment and treatment sequence.||ng/mL||Standard Deviation|Mean
820891|NCT01147926|Secondary|Percentage of Subjects With an Average Weekly Frequency of at Least 3 SCBM Per Week and an Increase of ≥ 1 SCBM Per Week for ≥ 75% of the 12-week Treatment Period and ≥ 75% of the Last Third of the 12-week Treatment Period||Over 12 week treatment period|mITT||percentage of subjects|||Number
820683|NCT01147341|Primary|Proportion of Subjects Achieving an American College of Rheumatology 20% (ACR20) Response Criteria in the Cimzia Treatment Group Compared to the Placebo Group|"ACR20 responders are subjects with at least 20% improvement from baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale(VAS).
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do.
Visual Analog Scale (VAS) - assessment of arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad."|From Baseline to Week 12|35 subjects were included in the efficacy assessment at week 12. Subjects in the efficacy assessment at week 12 completed at least 4 weeks of dosing. 30 subjects who completed the 24 week study were included in the efficacy assessment at week 24.||participants|||Number
820684|NCT01147341|Secondary|Proportion of Subjects Achieving an American College of Rheuamtology Low Disease Activity Score and/or Remission Score in the Cimzia Group Compared to the Placebo Group as Calculated by DAS28 (CRP)|"The Disease Activity Score-28-C-reactive Protein (DAS28-CRP)is a composite measure for rheumatoid arthritis (RA) is based on 4 variables: tender and swollen joint counts (28 joints),C-Reactive Protein(CRP), and patient global assessment visual analog scale. A lower score indicated less disease activity.
Remission: CDAI ≤ 2.8; Low Disease Activity: CDAI > 2.8 and ≤ 10 ;Moderate Disease Activity: CDAI > 10 and ≤ 22; High Disease Activity: CDAI > 22"|Baseline to Week 12|35 subjects were included in the efficacy assessment at week 12. Subjects in the efficacy assessment at week 12 completed at least 4 weeks of dosing.||participants|||Number
820685|NCT01147341|Secondary|Proportion of Subjects Achieving an American College of Rheumatology 50% (ACR50) Response Criteria in the Cimzia Treatment Group Compared to the Placebo Group at Week 12|"ACR50 responders are subjects with at least 50% improvement from baseline for tender joint cout (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale.
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do.
Visual Analog Scale (VAS) - assessment of arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad."|Baseline to Week 12|35 subjects were included in the efficacy assessment at week 12. Subjects in the efficacy assessment at week 12 completed at least 4 weeks of dosing||participants|||Number
820686|NCT01147341|Primary|Proportion of Subjects Achieving a Clinical Disease Activity Index (CDAI) Decrease of Greater Than or Equal to 10 Points in the Cimzia Treatment Group Compared to the Placebo Group at Week 12|The Clinical Disease Activity (CDAI)is a composite score. Clinical Disease Activity (CDAI) = SJC(28): Swollen 28-Joint Count (shoulders, elbows, wrists, MCPs, PIPs (including thumb IP)+ TJC(28): Tender 28-Joint Count (shoulders, elbows, wrists, MCPs, PIPs (including thumb IP)+ PGA: Patient Global disease Activity (patient’s self assessment of overall RA disease activity on a scale 0-10 where 10 is maximal activity)+ EGA: Evaluator’s Global disease Activity (evaluator’s assessment of overall RA disease activity on a scale 0-10 where 10 is maximal activity) Remission: CDAI ≤ 2.8; Low Disease Activity: CDAI > 2.8 and ≤ 10 ;Moderate Disease Activity: CDAI > 10 and ≤ 22; High Disease Activity: CDAI > 22. A CDAI reduction of 6.5 represents moderate improvement.|Baseline to week 12|35 subjects were included in the efficacy assessment at week 12. Subjects in the efficacy assessment at week 12 completed at least 4 weeks of dosing||participants|||Number
820687|NCT01147380|Secondary|Anti-HCV Effect of This Treatment (If Applicable)||2 year||||||
820688|NCT01147380|Secondary|Anti-HCC Effect of This Treatment||2 year||||||
820689|NCT01147380|Secondary|NK Cell Infusion-related Toxicity|To assess NK cell infusion -related toxicity at the bedside. We will monitor the patient and check the vital sign. If any side effect are noticed, we will record and report to the data safety monitoring comittee.|1 year|Participants were devided two group( small and large dose) as described based on the dose of infused cell numbers.||participants|||Number
820690|NCT01147380|Primary|Side Effect of Cadaveric Donor Liver NK Cell Infusion|Side effect of cadaveric donor liver NK cell infusion We will measure the occurence of the side effect of the liver NK cell infusion. We will monitor the patient condition clinically. If any side effect are noticed, we will record them and report to the data safety monitoring comittee.|1 year|||participants|||Number
820691|NCT01147393|Primary|The Primary Objective of the Phase II Portion of the Study is to Determine the Anti-tumor Efficacy, as Measured by Response Rate, of Fractionated 90Y-epratutumab IgG Given in Combination With Veltuzumab Anti-CD20 IgG Therapy|||Data were not collected|||||
820692|NCT01147393|Primary|Safety|||Data was not evaluated|||||
820693|NCT01147393|Primary|Dose-limiting Toxicity|"NCI CTC version 3.0 is used to grade all adverse events and to provide management guidelines for infusional toxicity. Dose-limiting toxicity (DLT) is defined as follows:
Hematologic: Grade 4 toxicity >7 days, as specified by hemoglobin levels, platelet counts or absolute neutrophil count (ANC) or failure of hemoglobin levels, platelet counts or ANC to recover to Grade 1 levels within 12 weeks of completing the treatment cycle (with the use of RBC and platelet transfusions or growth factors during the 12 weeks if necessary, but at least one week without any support prior to qualifying Grade 1 levels).
Non-Hematologic: Any Grade 3 or Grade 4. Other: Any Grade 2 autoimmune reactions, or the occurrence of Grade 2 immediate-type allergic/hypersensitivity reactions (e.g., urticaria, wheezing, hypoxia and dyspnea) will be considered DLT and will also require the infusion to be permanently terminated.
Occurrence of DLT requires a patient’s treatment to be permanently discontinued"||Data were not collected|||||
820694|NCT01147393|Primary|Determine the Maximum Tolerated 90Y Dose|||Data was not collected|||||
820712|NCT01147471|Primary|Morbidity|total days on ventilator, ICU length of stay, hospital length of stay|Measured daily during hospitalization (approx 1 month)|analysis is the mean and standard deviation for # days spent on each item measured||days||Standard Deviation|Mean
820699|NCT01147458|Secondary|Rescue Medication Use|Rescue medication use was collected daily in a daily diary, in which participants noted the amount of rescue medication (number of pills) taken each day. Participants were provided with rescue medication paracetamol/acetaminophen throughout the study including the Washout Period and the Initial Pain Assessment Period. Paracetamol/acetaminophen was taken as needed to a maximum of 2000 mg per day, but must be discontinued 48 hours prior to the Baseline visit (Visit 3). From Visit 3 onwards, participants might take up to 2000 mg of paracetamol/acetaminophen per day up to 3 days per week.|Day -7 (Visit 2) up to 28-day follow-up (Visit 10)|Number of subjects analyzed (N) is the number of participants taking rescue mediation.||Number of pills||Standard Deviation|Mean
820700|NCT01147458|Secondary|Daily Diary Pain Score During Week 2 of Each Treatment Period|The daily diary pain was assessed using an 11-point numerical rating scale (NRS) ranging from 0 to 10 (0 = no pain; 10 = the worst pain possible).|Over the last 4 days before baseline visits (Visits 3 for Period 1 and Visit 8 for Period 2) and over the last 6 days before Visit 5 for Period 1 and Visit 9 for Period 2|Full Analysis Set (FAS): included all participants randomized who received at least one dose of study drug, regardless of whether they had efficacy data.||Units on a scale||Standard Deviation|Mean
820701|NCT01147458|Secondary|Daily Diary Pain Score During Week 1 of Each Treatment Period|The daily diary pain was assessed using an 11-point numerical rating scale (NRS) ranging from 0 to 10 (0 = no pain; 10 = the worst pain possible).|4 days prior to baseline visits (Visits 3 for Period 1 and Vist 8 for Period 2) up to 7 days after baseline visits|Full Analysis Set (FAS): included all participants randomized who received at least one dose of study drug, regardless of whether they had efficacy data.||Units on a scale||Standard Deviation|Mean
820702|NCT01147458|Secondary|Importance Weighted Total WOMAC Score|Importance weighted total WOMAC score was calculated using all subscales including Pain, Stiffness and Physical Function subscales (24 questions in total,score range: 0=none to 4= extreme,giving a possible overall score range of 0-96).Lower subscale scores represent less pain, less stiffness, or better physical performance.|Baseline (Day 1 of Visit 3 for Period 1 and Day 28 of Visit 7 for Period 2), Day 15+1 of Visit 5 for Period 1, and Day 43+1 of Visit 9 for Period 2|Full Analysis Set (FAS): included all participants randomized who received at least one dose of study drug, regardless of whether they had efficacy data.||Units on a scale||Standard Deviation|Mean
820703|NCT01147458|Secondary|WOMAC Total Score|The WOMAC total score was calculated as the sum of Pain subscale score (5 questions), Stiffness subscale score (2 questions) and Physical Function subscale score (17 questions), with a total of 24 questions(score range:0=none, 4=extreme) giving a possible total score range from 0 to 96 . lower subscale scores represent less pain, less stiffness, or better physical performance.|Baseline (Day 1 of Visit 3 for Period 1 and Day 28 of Visit 7 for Period 2), Day 15+1 of Visit 5 for Period 1, and Day 43+1 of Visit 9 for Period 2|Full Analysis Set (FAS): included all participants randomized who received at least one dose of study drug, regardless of whether they had efficacy data.||Units on a scale||Standard Deviation|Mean
820704|NCT01147458|Secondary|WOMAC Physical Function Domain Score|The WOMAC Physical Function subscale refers to the participant's ability to move around and perform usual activities of daily living. The WOMAC Physical Function subscale, comprised of 17 questions regarding the degree of difficulty experienced in the index joint, was calculated as the mean of the scores from the 17 individual questions. The WOMAC Physical Function subscale scores for each question range from 0 to 4 giving a possible overall score range of 0-68, with higher scores indicating worse function.|Baseline (Day 1 of Visit 3 for Period 1 and Day 28 of Visit 7 for Period 2), Day 15+1 of Visit 5 for Period 1, and Day 43+1 of Visit 9 for Period 2|Full Analysis Set (FAS): included all participants randomized who received at least one dose of study drug, regardless of whether they had efficacy data.||Units on a scale||Standard Deviation|Mean
820705|NCT01147458|Secondary|WOMAC Stiffness Domain Score|The WOMAC Stiffness subscale, comprised of 2 questions regarding the amount of stiffness experienced in the index joint, was calculated as the mean of the scores from the 2 individual questions. The WOMAC Stiffness subscale scores for each question range from 0 to 4 giving a possible overall score range of 0-8, with higher scores indicating more stiffness.|Baseline (Day 1 of Visit 3 for Period 1 and Day 28 of Visit 7 for Period 2), Day 15+1 of Visit 5 for Period 1, and Day 43+1 of Visit 9 for Period 2|Full Analysis Set (FAS): included all participants randomized who received at least one dose of study drug, regardless of whether they had efficacy data.||Units on a scale||Standard Deviation|Mean
820706|NCT01147458|Primary|Change From Baseline in Western Ontario & McMaster (WOMAC) Osteoarthritis Index Pain Score at the End of Treatment Period 2|The WOMAC Pain subscale, comprised of 5 questions regarding the amount of pain experienced in the index joint, was calculated as the mean of the scores from the 5 individual questions. The WOMAC Pain subscale scores for each question range from 0 to 4 giving a possible overall score range of 0-20, with higher scores indicating higher pain.|Baseline (Day 28 of Visit 7) and end of treatment Period 2 (Day 43+1 of Visit 9)|Full Analysis Set (FAS): included all participants randomized who received at least one dose of study drug, regardless of whether they had efficacy data.||Units on a scale||Standard Deviation|Mean
820707|NCT01147458|Primary|Change From Baseline in Western Ontario & McMaster (WOMAC) Osteoarthritis Index Pain Score at the End of Treatment Period 1|The WOMAC Pain subscale, comprised of 5 questions regarding the amount of pain experienced in the index joint, was calculated as the mean of the scores from the 5 individual questions. The WOMAC Pain subscale scores for each question range from 0 to 4 giving a possible overall score range of 0-20, with higher scores indicating higher pain.|Baseline (Day 1 of Visit 3) and end of treatment Period 1 (Day 15+1 of Visit 5)|Full Analysis Set (FAS): included all participants randomized who received at least one dose of study drug, regardless of whether they had efficacy data.||Units on a scale||Standard Deviation|Mean
820708|NCT01147471|Other Pre-specified|Still on Narcotics at Post-discharge Follow-up|Number of people still on narcotics at time of routine care post-discharge follow-up|approx 2 weeks post discharge|||participants|||Number
820709|NCT01147471|Secondary|Pulmonary Function|Pulmonary function tests to measure forced vital capacity (FVC) and forced expiratory volume one (FEV1).|Measured at 3 and 6 months post-discharge|Data not collected - insufficient participants completed follow up visits|||||
820710|NCT01147471|Secondary|Quality of Life|Rand 36 health survey.|Measured at 3 and 6 months post-discharge|Data not collected - insufficient participants completed follow up visits|||||
820711|NCT01147471|Primary|Mortality|Number of participants who died during any hospital stay.|Measured any time during hospital stay (approx 30 days)|||participants|||Number
820738|NCT01141725|Secondary|Disease-free Survival (DFS)|In a five year following, the disease free survival was obtained.|5 years|Data for this Outcome Measure was not collected per dose level and is unavailable.||days||95% Confidence Interval|Median
820739|NCT01141725|Primary|Median Survival|In a five year following, the median survival was obtained.|5 years|||months||Full Range|Median
820740|NCT01141725|Primary|Maximum Tolerated Dose|A bayesian approach to estimate the MTD of bendamustine associated with a CR rate of at least 40% and with <30% grade 3–4 non-haematological toxicity was used (Wathen et al, 2008).The MTD of bendamustine in combination with idarubicin was determined after two cases of grade 3 toxicity were noted in the three patients entered at the 75 mg/m2 dose. The DLTs were congestive heart failure and mucositis in one patient each. Patients subsequent to this were treated at the 60 mg/m2 bendamustine dose.|6 months|||mg/m2|||Number
820741|NCT01141725|Primary|Incidence of Greater Than or Equal to Grade 3 Toxicity|Toxicities will be graded using the National Cancer Institute (NCI) Common Toxicity Criteria version 3.0.|Up to day +100 after end of therapy or until the patient received an alternative treatment for leukemia, whatever happens earlier|||Participants|||Count of Participants
820742|NCT01141725|Primary|Response|Assessed by cytogenetics/fluorescence in situ hybridization (FISH) and flow cytometry of blood and bone marrow samples. The response criteria defined by Cheson et al. will be used in this study. These criteria are: morphologic leukemia-free state; morphologic complete remission (CR); cytogenetic CR (CRc); molecular CR (CRm); morphologic CR with incomplete blood count recovery (CRi); partial remission (PR); treatment failure; recurrence (progressive disease).|6 months|||Participants|||Count of Participants
820743|NCT01142115|Secondary|Haematuria|"Negative or positive result on a multistix urin analysis.
Negative haematuria: 10 erythrocytes/microliter or less. Positive haematuria: above 10 erythrocytes/microliter."|2 hours after catheterisation at visits 1 and 2|ITT||participants|||Number
820953|NCT01149460|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) - Valacyclovir|Bioequivalence based on AUC0-t|Blood samples collected over 12 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
820744|NCT01142115|Secondary|Visible Blood|"Visual blood observed on the catheter or in the urine in connection to catheterization.
The nurse who conducted the catheterization could answer yes or no as follows:
Yes = visible blood observed. No = no visible blood observed."|10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1|ITT||participants|||Number
820745|NCT01142115|Secondary|Ease of Use Measured on a 5 Point Scale: Withdrawal Effort|"After each catheterization the nurse who conducted the catheterization answered how the catheter withdrawal had been.
There were 5 answer categories: very difficult - difficult - neither easy nor difficult - easy - very easy"|10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1|ITT||participants|||Number
820746|NCT01142115|Secondary|Ease of Use Measured on a 5 Point Scale: Insertion Effort|"After each catheterization the nurse who conducted the catheterization answered how the catheter insertion had been.
There were 5 answer categories: very difficult - difficult - neither easy nor difficult - easy - very easy"|10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1|ITT||participants|||Number
820747|NCT01142115|Secondary|Irritation During Voiding After Catheterization|"After each catheterization subjects were asked if they felt any irritation during voiding with answer option yes or no.
Yes - they experienced irritation. No - they did not experience irritation."|10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1|ITT||Participants|||Number
820748|NCT01142115|Primary|Discomfort Measured on the Visual Analog Scale (VAS)|"Outcome measured on a 10 cm Visual Analog Scale ranging from no discomfort (0cm) to worst thinkable discomfort (10cm)."|10 minutes after each catheterisation at visit 1 and at visit 2 which is 5-25 days after visit 1|Intention to Treat (ITT) population||cm||Standard Deviation|Mean
820749|NCT01142128|Primary|Reduction of Abdominal Pain in Participants Taking Viokase 16 Plus Placebo.|To elucidate the role of Viokase 16 and Nexium in the control of pancreatic pain|4 months|Analysis was not able to be done due to the small sample size.|||||
820750|NCT01142128|Primary|Reduction of Abdominal Pain in Participants Taking Viokase 16 Plus Nexium|To elucidate the role of Viokase 16 and Nexium in the control of pancreatic pain|4 months|Analysis was not able to be done due to the small sample size.|||||
820751|NCT01142128|Primary|Reduction of Abdominal Pain for Participants Taking Placebo to Nexium|To elucidate the role of Viokase 16 and Nexium in the control of pancreatic pain|4 months|Analysis was not able to be done due to the small sample size.|||||
820752|NCT01142128|Primary|Reduction of Abdominal Pain for Participants Taking Nexium Alone.|To elucidate the role of Viokase 16 and Nexium in the control of pancreatic pain|4 months|Analysis was not able to be done due to the small sample size.|||||
820753|NCT01147601|Secondary|Compare Treatment Group to Control Group Improvement Assessments|"The proportion of subjects in the treatment group as compared to the placebo control group with at least 50% improvement in the extent of the hemangioma.
The difference between the extent/size of the hemangioma as an outcome measure versus color changes.
Frequency of adverse events (e.g. hypotension, behavioral changes, etc.), collected by the investigator and reported by the parents."|at 6 months||||||
820754|NCT01147601|Primary|Proportion of Subjects in Treatment Group Compared to Placebo Group With at Least 75% Improvement in the Extent of the Hemangioma as Compared to Baseline Photos.|This will be generated by asking each of the assessors to score the improvement using a visual analog scale (VAS) assessing the decrease in size of hemangioma by comparing photographs at different times of treatment. The assessors will score this improvement into one of the following categories: 0-24%, 25-49%, 50-74%, >75%.|at 6 months|||Participants|||Count of Participants
820755|NCT01147627|Secondary|Safety and Tolerability in Different Groups||48 weeks||||||
820756|NCT01147627|Secondary|β-cell Function (Acute Insulin Response During IVGTT; HOMA-B, Disposition Index and Proinsulin/Insulin Ratio)||48 weeks||||||
820757|NCT01147627|Secondary|Percentage of Patients Achieving HbA1c <7% and ≤ 6.5% and Effect of Different Interventions on Fasting and Postprandial Plasma Glucose Concentration, Blood Pressure, Lipid Profiles||48 weeks||||||
820758|NCT01147627|Primary|the Comparison Between Treatment Groups of the Changes From Baseline in HbA1c at 48 Weeks||48 weeks|||percentage of HbA1c||Standard Deviation|Mean
820759|NCT01147640|Secondary|Microbiological Response of CXA 101/Tazobactam and Metronidazole at the TOC Visit in the Microbiologically Evaluable (ME) Population|Microbiological response is eradication (absence of the baseline pathogen from a suitable intra-abdominal specimen) or presumed eradication (absence of a suitable intra-abdominal specimen to culture at the TOC visit in a subject who is assessed as a clinical cure at TOC)|Test-of-Cure Visit (7-14 days after EOT)|Microbiologically Evaluable: treated subjects, with baseline pathogen susceptible to study drug, complied with protocol||percentage of subjects||95% Confidence Interval|Number
820760|NCT01147640|Primary|Clinical Response of CXA 101/Tazobactam and Metronidazole at Test of Cure (TOC) Visit in the Microbiological Modified Intent to Treat (mMITT) Analysis Population|Clinical response is complete resolution or significant improvement of all signs and symptoms of the index infection, such that no additional antibacterial therapy or surgical or drainage procedure was required for the index infection.|Test-of-Cure Visit (7-14 days after End of Therapy [EOT])|mMITT: Treated subjects, with baseline pathogen||percentage of subjects||95% Confidence Interval|Number
820954|NCT01149460|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma) - Valacyclovir|Bioequivalence based on Cmax|Blood samples collected over 12 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
820862|NCT01147900|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs).|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject..|At Year 8.5|Analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of Boostrix™ vaccine, any formulation, for whom data were available.||subjects|||Number
820791|NCT01147744|Secondary|Number of Participants Who Withdrew Due to Lack of Efficacy During the 8-Week Treatment Period|The participants who met any of the following withdrawal criteria were considered to be withdrawn due to lack of efficacy: 1) Clinic FEV1 below stability limit calculated at Visit 3. 2) More than three days between two consecutive visits, PEF has fallen below stability limit calculated at Visit 3. 3) Use of 12 or more inhalations of SABA per day for more than two days between consecutive visits. 4) Asthma exacerbation defined as worsening requiring any treatment other than study medication or rescue medication. This included requiring the use of systemic or inhaled corticosteroids and /or emergency room visit or hospitalization for the treatment of asthma. The stability limit was calculated as best pre-salbutamol/albuterol FEV1 at Visit 3 x 80 percent (%).|Upto 8 Weeks|ITT Population. Only those participants with analyzable data at the indicated time point were assessed.||Participants|||Count of Participants
820792|NCT01147744|Secondary|Mean Change From Baseline in Night-time Rescue SABA Usage Over the 8-Week Treatment Period|The numbers of inhalations of rescue SABA, salbutamol/albuterol inhalation aerosol used during the day and night was recorded by the participants in an eDiary. Participants who used salbutamol/albuterol inhalation aerosol at night-time were assessed during the 8-Week treatment period. Change from Baseline was calculated as the averaged number of night-time salbutamol/albuterol inhalation aerosol used during the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants).|Baseline up to Week 8|ITT Population. Endpoint obtained from the daily diary record used all available data over the period of interest. No imputations were performed on missing data from the daily diary record.||Night-time number of inhalations||Standard Error|Least Squares Mean
820793|NCT01147744|Secondary|Mean Change From Baseline in Day-time Rescue Short Acting beta2-agonist (SABA) Usage Over the 8-Week Treatment Period|The number of inhalations of rescue SABA, salbutamol/albuterol inhalation aerosol used during the day and night was recorded by the participants in an eDiary. Participants who used salbutamol/albuterol inhalation aerosol at day-time were assessed during the 8-Week treatment period. Change from Baseline was calculated as the averaged number of day-time salbutamol/albuterol inhalation aerosol used during the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants).|Baseline up to Week|ITT Population. Endpoint obtained from the daily diary record used all available data over the period of interest. No imputations were performed on missing data from the daily diary record.||Day-time number of inhalations||Standard Error|Least Squares Mean
820794|NCT01147744|Secondary|Mean Change From Baseline in Night-time Asthma Symptom Score Over the 8-Week Treatment Period|Participants recorded their night-time asthma symptom score in an eDiary each AM upon rising and before taking any rescue or study medication and before assessing the PEF measurement during the 8-Week treatment period. Night-time asthma symptom scores, as: 0=no asthma symptoms, 1= one awakening or waking early due to asthma symptoms, 2= two or more awakenings due to asthma symptoms (including waking early), 3= asthma symptoms almost prevented the participant from sleeping, 4= severe asthma symptoms completely prevented from sleeping. Change from Baseline was calculated as the averaged of night-time asthma symptom score during the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants).|Baseline up to Week 8|ITT Population. Endpoint obtained from the daily diary record used all available data over the period of interest. No imputations were performed on missing data from the daily diary record.||Night-time symptom scores on a scale||Standard Error|Least Squares Mean
820795|NCT01147744|Secondary|Mean Change From Baseline in Day-time Asthma Symptom Score Over the 8-Week Treatment Period|Participants recorded their day-time asthma symptom score in an eDiary each PM at bedtime and before taking any rescue or study medication and before assessing the PEF measurement during the 8-Week treatment period. Day-time asthma symptom scores, as: 0=no asthma symptoms, 1=one episode of short-time asthma symptoms, 2=two or more episodes of short-time asthma symptoms, 3=asthma symptoms occurring during most part of daytime without interference with daily life activities, 4=asthma symptoms occurring during most part of daytime with interference with daily life activities, 5=severe asthma symptoms that disable working or perform normal daily activities. Change from Baseline was calculated as the averaged of day-time asthma symptom score during the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants).|Baseline up to Week 8|ITT Population. Endpoint obtained from the daily diary record used all available data over the period of interest. No imputations were performed on missing data from the daily diary record.||Day-time symptom scores on a scale||Standard Error|Least Squares Mean
820796|NCT01147744|Secondary|Mean Change From Baseline in the Percentage of Rescue-free Nights Averaged Over the 8-Week Treatment Period|The number of inhalations of rescue salbutamol/albuterol inhalation aerosol used during the day and night was recorded by the participants in an eDiary. The time span during which the participants did not have to take any rescue medication (medication intended to relieve symptoms immediately) was considered to be a rescue-free period. For participants, the rescue-free nights were assessed during the 8-Week treatment period. Change from Baseline was calculated as the averaged of rescue-free nights during the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants).|Baseline up to Week 8|ITT Population. Endpoint obtained from the daily diary record used all available data over the period of interest. No imputations were performed on missing data from the daily diary record.||Percentage of rescue-free nights||Standard Error|Least Squares Mean
820797|NCT01147744|Secondary|Mean Change From Baseline in the Percentage of Rescue-free Days Averaged Over the 8-Week Treatment Period|The number of inhalations of rescue salbutamol/albuterol inhalation aerosol used during the day and night was recorded by the participants in an eDiary. The time span during which the participants did not have to take any rescue medication (medication intended to relieve symptoms immediately) was considered to be a rescue-free period. For participants, the rescue-free days were assessed during the 8-Week treatment period. Change from Baseline was calculated as the averaged of rescue-free days during the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants).|Baseline up to Week 8|ITT Population. Endpoint obtained from the daily diary record used all available data over the period of interest. No imputations were performed on missing data from the daily diary record.||Percentage of rescue-free days||Standard Error|Least Squares Mean
820798|NCT01147744|Secondary|Mean Change From Baseline in the Percentage of Symptom-free Nights Averaged Over the 8-Week Treatment Period|Asthma symptoms were recorded in a daily eDairy by the participants every day in the morning upon rising and before taking any rescue or study medication and before the assessment of the PEF measurement. Participant’s responses to the morning assessments indicated no symptoms were considered to be symptom free. For participants, the symptom free nights were assessed during the 8-Week treatment period. Change from Baseline was calculated as the averaged of symptom-free nights during the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants).|Baseline up to Week 8|ITT Population. Endpoint obtained from the daily diary record used all available data over the period of interest. No imputations were performed on missing data from the daily diary record.||Percentage of symptom-free nights||Standard Error|Least Squares Mean
820799|NCT01147744|Secondary|Mean Change From Baseline in the Percentage of Symptom-free Days Averaged Over the 8-Week Treatment Period|Asthma symptoms were recorded in a daily electronic diary (eDiary) by the participants every day in the evening at bedtime and before taking any rescue or study medication and before the assessment of the PEF measurement. Participant’s responses to evening assessments indicated no symptoms were considered to be symptom free. For participants, the symptom free days were assessed during the 8-Week treatment period. Change from Baseline was calculated as the averaged of symptom-free days during the 8-Week treatment period minus the Baseline value. Baseline was defined as the last 7 days prior to randomization of the participants.|Baseline up to Week 8|ITT Population. Endpoint obtained from the daily diary record used all available data over the period of interest. No imputations were performed on missing data from the daily diary record.||Percentage of symptom-free days||Standard Error|Least Squares Mean
820800|NCT01147744|Secondary|Mean Change From Baseline in Daily Trough AM PEF Averaged Over the 8-Week Treatment Period|The PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Trough AM PEF is defined as the AM pre-dose and pre-rescue bronchodilator at the clinic visit. Change from Baseline was calculated as the value of the averaged PEF daily (pre-dose and pre-rescue bronchodilator) AM over the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants).|Baseline up to Week 8|ITT Population. Only those participants with analyzable data at the indicated time point were assessed.||Liters per minute||Standard Error|Least Squares Mean
820801|NCT01147744|Secondary|Mean Change From Baseline in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 8-Week Treatment Period|Peak expiratory flow is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Change from Baseline was calculated as the value of the averaged PEF daily (pre-dose and pre-rescue bronchodilator) evening over the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants)|Baseline up to Week 8|ITT Population. Only those participants with analyzable data at the indicated time point were assessed.||Liters per minute||Standard Error|Least Squares Mean
820810|NCT01147809|Secondary|Mean Day 15 Scheduled Pre-chemotherapy Platelet Counts Evaluated Across Cycles 1 to 6 in Phase II|Scheduled pre-chemotherapy platelet count is defined within each cycle as the platelet count assessment on which the decision to give or delay chemotherapy was made. This was averaged for each subject across cycles 1 to 6 and a natural log transformation was applied to the average. The log-transformed values were compared between eltrombopag and placebo groups using an analysis of covariance (ANCOVA) model adjusting for cycle duration (21-day vs. 28-day), baseline loge(platelet count) and part of study (part 1 or 2 of phase II). The number of participants analyzed is the number with a Day 15 scheduled platelet count.|Day 15 (averaged across cycles 1 to 6)|ITT Population||Giga (10^9) cells per liter (G cells/L)||Geometric Coefficient of Variation|Geometric Mean
820802|NCT01147744|Primary|Mean Change From Baseline to the End of the 8-Week Treatment Period in Trough Forced Expiratory Volume in One Second (FEV1)|Pulmonary function was measured by forced expiratory volume in one second, defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is defined as the morning (AM) pre-dose and pre-rescue bronchodilator FEV1 at the clinic visit. Baseline was the pre-dose value obtained at Visit 3. Change from Baseline was calculated as the end of Week 8 value minus the Baseline value. Analysis of covariance (ANCOVA) model used for statistical analysis. ITT Population was comprised of all participant randomized to treatment who received at least one dose of double-blind study medication.|Baseline and Week 8|ITT population. When possible, data from participants who withdrew prematurely from the study were included in the analyses. Any evaluable subject whose FEV1 measurement at Week 8 was missing was included in the analysis by imputation, using the preceding non-missing FEV1 value (last observation carried forward [LOCF]).||Liters||Standard Error|Least Squares Mean
820803|NCT01147809|Secondary|Time to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase II|Platelet nadir is defined within each cycle as the lowest platelet count reported after the Day 1 chemotherapy dose. TR (>100Gi/L or >150Gi/L) from platelet nadir is defined within each cycle as the time in days from the platelet nadir to the time at which platelet count returns to >=100Gi/L or >=150Gi/L within the same cycle or up to and including Day 1 of the next cycle. For the last cycle in the study, time to recovery was calculated in the same manner but up to and including any Conclusion/Early Withdrawal visit which has been assigned to the same cycle. Blood samples were collected to estimate platelet count at: 21-day cycle; Days 1, 4, 8, 15 and 17 of Cycles 1 to 6. 28-day cycle; Days 1, 4, 8, 15, 22, and 24of Cycles 1 to 6. Time to recover censored if platelet count did not return to >=100/150 Gi/L. Censored results are excluded from calculation of summary statistics. Only those participants available at indicated time points were analyzed (represented by n=X, X).|Cycle 1 to Cycle 6|ITT Population||Days||Standard Deviation|Mean
820804|NCT01147809|Secondary|Time Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase II|Platelet nadir is defined within each cycle as the lowest platelet count reported after the Day 1 chemotherapy dose. The time taken to reach platelet nadir is defined within each cycle. Blood samples were collected to estimate platelet nadir count at the following time points: 21-day cycle; Days 1, 4, 8, 15 and 17 of Cycles 1 to 6. 28-day cycle; Days 1, 4, 8, 15, 22 and 24 of Cycles 1 to 6. Only those participants available at indicated time points were analyzed (represented by n=X, X).|Cycle 1 to Cycle 6|ITT Population||Days||Standard Deviation|Mean
820805|NCT01147809|Secondary|Maximum Duration of Thrombocytopenia Across Cycles 1 to 6 in Phase II|Duration of thrombocytopenia is defined as a period of time in days from the first report of a platelet count with NCI CTCAE Grade 1-4 until the first subsequent report of a platelet count no longer meeting those criteria, regardless of rescue medication usage. It was assessed between Day 1 of Cycle 2 and up to and including any Conclusion/Early Withdrawal visit assigned to the same cycle for participants completing up to 6 cycles, and between Day 1 of Cycle 2 and up to and including the end of Cycle 6 for participants continuing beyond 6 cycles. The chemotherapy cycle for 21-day cycle was 21 days and for 28-day cycle was 28 days. Blood samples were collected to estimate thrombocytes at the following time points: 21-day cycle; Days 1, 4, 8, 15 and 17 of Cycles 2 to 6. 28-day cycle; Days 1, 4, 8, 15, 22 and 24 of Cycles 2 to 6.|Cycle 1 to Cycle 6|ITT Population: Participants with at least one period of thrombocytopenia where duration could be calculated.||Days||Standard Deviation|Mean
820806|NCT01147809|Secondary|Number of Participants With Thrombocytopenia of Grade 1, 2, 3 or 4 Across Cycles 1 to 6 in Phase II|As per the CTCAE version 4.0, participants with a platelet count <LLN but >=75 x 10^9/L (Gi/L) were considered to have Grade 1 thrombocytopenia; participants with a platelet count <75Gi/L, but >=50Gi/L were considered to have Grade 2 thrombocytopenia; participants with a platelet count <50Gi/L, but >=25Gi/L were considered to have Grade 3 thrombocytopenia and participants with a platelet count <25Gi/L were considered to have Grade 4 thrombocytopenia. Blood samples were collected to estimate thrombocytes at the following time points: 21-day cycle; Days 1, 4, 8, 15 and 17 of Cycles 1 to 6. 28-day cycle; Days 1, 4, 8, 15, 22 and 24 of Cycles 1 to 6. Participants experiencing thrombocytopenia(Platelets <150Gi/L) at least once within cycle are presented in the category title as n=X,X.|Cycle 1 to Cycle 6|ITT Population||Participants|||Number
820807|NCT01147809|Secondary|Average Daily Area Under the Platelet-time Course Across Cycles 1 to 6 in Phase II|The average daily area under the platelet-time course was normalized by dividing the area under curve by total duration. This gives an estimated average platelet value over the time period from cycles 1 to 6. Blood samples were collected to estimate platelet count at the following time points: 21-day cycle; Days 1, 4, 8, 15 and 17 of Cycles 1 to 6. 28-day cycle; Days 1, 4, 8, 15, 22 and 24 of Cycles 1 to 6.|All assessments from Cycle 1 Day 1 to last assessment in Cycle 6|ITT Population:Participants with platelet count data in at least one cycle in the study.||Giga (10^9) cells per liter (G cells/L)||Standard Deviation|Mean
820808|NCT01147809|Secondary|Platelet Count Nadir for Each Chemotherapy Cycle in Phase II|Platelet nadir is defined as the lowest platelet count reported after the first dose of chemotherapy within each cycle. Platelet count nadir is defined for each cycle. Blood samples were collected to estimate platelet nadir count at the following time points: 21-day cycle; Day 1, Day 4, Day 8, Day 15 and Day 17 of Cycles 1 to 6. 28-day cycle; Day 1, Day 4, Day 8, Day 15, Day 22, Day 24 of Cycles 1 to 6. Only those participants available at indicated time points were analyzed (represented by n=X, X).|Cycle 1 to Cycle 6|ITT Population||Giga (10^9) cells per liter (G cells/L)||Standard Deviation|Mean
820809|NCT01147809|Secondary|Mean Within-subject Platelet Count Prior to Scheduled Chemotherapy Across Cycles 1 to 6 in Phase II|Within-subject platelet count for each par. was calculated by summing up the visit platelet counts from each of Cycles 1 to 6 and dividing it by the number of cycles in which the par. had data. The average within a treatment group was calculated by summing up the values from each par. within the treatment 21-day cycle dividing it by the number of par. These platelet counts are different from the pre-chemotherapy platelet counts for cycles where the chemotherapy dose was delayed. Average within-subject central laboratory platelet count prior to scheduled chemotherapy across Cycles 1 to 6 are summarized. Blood samples were collected on Day 1 and 8 of Cycles 1 to 6 for 21-day cycle and on Day 1, 8 and 15 from Cycles 1 to 6 for 28-day cycle to estimate the average within subject platelet count prior to scheduled chemotherapy. Only those participants available at the indicated time points were analyzed (represented by n=X,X in the category titles).|Day 1, Day 8, Day 15 (all averaged across cycles 1 to 6)|ITT Population||Giga (10^9) cells per liter (G cells/L)||Standard Deviation|Mean
820811|NCT01147809|Secondary|Mean Day 8 Scheduled Pre-chemotherapy Platelet Counts Evaluated Across Cycles 1 to 6 in Phase II|Scheduled pre-chemotherapy platelet count is defined within each cycle as the platelet count assessment on which the decision to give or delay chemotherapy was made. This was averaged for each subject across cycles 1 to 6 and a natural log transformation was applied to the average. The log-transformed values were compared between eltrombopag and placebo groups using an analysis of covariance (ANCOVA) model adjusting for cycle duration (21-day vs. 28-day), baseline loge(platelet count) and part of study (part 1 or 2 of phase II). The number of participants analyzed is the number with a Day 8 scheduled platelet count.|Day 8 (averaged across cycles 1 to 6)|ITT Population||Giga (10^9) cells per liter (G cells/L)||Geometric Coefficient of Variation|Geometric Mean
820812|NCT01147809|Secondary|Number of Participants With Electrocardiogram (ECG) Findings at Cycle 1 Day 4 (2 to 6 Hours Post-dose) in Phase II|A single safety 12-lead ECG was performed using a standard 12-lead ECG machine at screening and 2 to 6 hours post-dose on C1D4. Change in ECG findings were categorized as 'Clinically significant change (CSC): favorable', 'No change or insignificant change' or 'Clinically significant change (CSC): unfavorable' as determined by the investigator. The Baseline value is defined as the value reported immediately prior to the administration of the first dose of investigational product. Only those participants available at the indicated time points were analyzed (represented by n=X,X in the category titles).|C1D4|Safety Population||participants|||Number
820813|NCT01147809|Secondary|Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase II|ECOG-Zubrod scores for the Performance Status were defined as follows: 0: Fully active, 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, 2: Ambulatory and capable of all self-care but unable to carry out any work activities, 3: Capable of only limited self-care, 4: Completely disabled, 5 and Unknown: Dead. The data is presented for the participants with the ECOG performance score at different time points during the study. Only those participants available at the indicated time points were analyzed (represented by n=X,X in the category titles).|Screening, C1D1, C2D1, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1, C9D1, C10D1, C11D1, C12D1, C13D1, C14D1, C15D1, C16D1 and C17D1|Safety Population||participants|||Number
820814|NCT01147809|Secondary|Number of Participants With Change From Baseline in Creatinine of >=26.5 UMOL/L in Phase II|Number of participants with at least 1 assessment of change from Baseline in creatinine, with increase >=26.5 UMOL/L are presented. The Baseline value is defined as the value reported immediately prior to the administration of the first dose of IP.|After baseline (C1D1), on-treatment (collected on days 1 and 8 for subjects on 21-day cycle and on days 1, 8 and 15 for subjects on 28-day cycle) and 30 day follow-up|Safety Population||participants|||Number
820815|NCT01147809|Secondary|Number of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase II|"Clinical chemistry laboratory parameters with a related CTCAE (version 4.0) toxicity grading were summarized by toxicity grade at each scheduled assessment. Worst-case grade change of the laboratory parameters at anytime post-Baseline is presented as Any grade increase, Increase to Grade 3 or Grade 4. Clinical chemistry laboratory parameters included Albumin (Al), creatinine, AST, ALT, ALP, TB, Calcium hypercalcemia (CaHy)/hypocalcemia (CaHo), Glucose hyperglycemia (GluHy)/hypoglycemia (GluHo), Potassium hypernatremia (KHy)/hyponatremia (KHo) and Sodium hypernatremia (NaHy)/hyponatremia (NaHo). The Baseline value is defined as the value reported immediately prior to the administration of the first dose of chemotherapy in Cycle 1. Post-Baseline is defined as any time after the first dose of chemotherapy in Cycle 1 up to and including all follow-up visits. Only those Participant available at the indicated time points were analyzed (represented by n=X,X in the category titles)."|After baseline (C1D1), on-treatment (collected on days 1 and 8 for subjects on 21-day cycle and on days 1, 8 and 15 for subjects on 28-day cycle) and 30 day follow-up|Safety Population||participants|||Number
820816|NCT01147809|Secondary|Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase II|Hematology parameters with a related NCI CTCAE (version 4.0) toxicity grading were summarized by toxicity grade at each scheduled assessment, the maximum toxicity grade reached by a participant post-Baseline was summarized. Hematology parameters included Hemoglobin (Hb) increased, Anemia, Lymphocyte count (Lym), platelet count, White Blood Cell count (WBC) and Total Absolute Neutrophil Count (Total ANC). The Baseline value is defined as the value reported immediately prior to the administration of the first dose of chemotherapy in Cycle 1. Post-Baseline is defined as any time after the first dose of chemotherapy in Cycle 1 up to and including all follow-up visits. participants with missing Baseline value were assumed to have normal Baseline value. Only those Participant available at the indicated time points were analyzed (represented by n=X,X in the category titles).|After baseline (C1D1), on-treatment and 30 day follow-up|Safety Population||Participants|||Number
820817|NCT01147809|Secondary|Dose Intensity of Gemcitabine Plus Cisplatin(G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1-6 in Phase II|Dose intensity of chemotherapy is defined as the actual dose of chemotherapy given as a percentage of the scheduled C1D1/C1D8 dose, as applicable, within this study: cycle Dose Intensity (%) = Total Actual dose (mg/m^2) within cycle *100/ Total Scheduled dose (mg/m^2) in Cycle 1; wherein Actual Dose (mg/m^2) = Actual dose (mg)/Body Surface Area reported on eCRF. The average chemotherapy dose intensity at Day 1 across Cycles 1 to 6, Day 8 across Cycles 1 to 6 and Day 15 across Cycles 1 to 6 was summarized and compared between treatment groups using an ANCOVA model adjusted for cycle duration and part of the study.|Cycle 1 to Cycle 6|ITT Population||Dose Intensity (%)||Standard Deviation|Mean
820818|NCT01147809|Secondary|Number of Participants With Any Dose Reduction in Their Scheduled Dose of Chemotherapy in Any Cycle in Phase II|Dose reductions are required following potential drug-related toxicities. Number of participants with any dose reduction during 21-day cycle or 28-day cycle, in part 1 or part 2 of the study is summarized and presented. Only participants who actually received chemotherapy were included for the cisplatin and carboplatin components. All participants were included for the gemcitabine components.|Cycle 1 to Cycle 6|ITT Population||Participants|||Number
820887|NCT01147926|Secondary|Percent SCBM With No Straining and Severe/Very Severe Straining|Straining was evaluated on a 5-point scale (0=none, 1=mild, 2=moderate, 3=severe, or 4=very severe)|Over 12 week treatment period|mITT. Not all subjects in the mITT population had data for this outcome.||percentage of SBM||Standard Deviation|Mean
820819|NCT01147809|Secondary|Number of Participants With at Least One Delay in Their Scheduled Dose of Chemotherapy in Any Cycle in Phase II|Any delay in scheduled dose of gemcitabine monotherapy or the combination of gemcitabine plus carboplatin or cisplatin was evaluated for eltrombopag and placebo treated participants. Number of participants with any delay in dose during 21-day cycle or 28-day cycle, in part 1 or part 2 of the study is summarized and presented. Only those participants who actually received chemotherapy are included for the cisplatin and carboplatin components and all participants are included for the gemcitabine components (represented by n=X,X in the category titles).|Cycle 1 to Cycle 6|ITT Population||Participants|||Number
820820|NCT01147809|Secondary|Number of Participants Requiring a Platelet Transfusion in Phase II|Platelet transfusion was used as a rescue medication for the treatment of thrombocytopenia. Number of participants requiring a platelet transfusion during Cycles 1-6 was summarized and compared between treatment groups using a logistic regression model adjusted for cycle duration. Each cycle included assessments starting at Day 1 of the cycle.|Screening, Day -5, throughout cycles 1 to 6 and up to 30 days after IP discontinuation|ITT Population||Participants|||Number
820821|NCT01147809|Secondary|Number of Participants With Any Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale, Across Cycles 1-6 in Phase II|The WHO Bleeding Scale is a measure of bleeding severity with the following grades: Grade 0=no bleeding; Grade 1=petechiae; Grade 2=mild blood loss; Grade 3=gross bleeding; Grade 4=debilitating blood loss. The WHO grades were further classified into the following categories: no bleeding=Grade 0; any bleeding=Grades 1 to 4; no clinically significant bleeding=Grades 0 to 1; clinically significant bleeding=Grades 2 to 4. Baseline is defined as the Day 1 assessment or the latest possible screening assessment. Across Cycles 1-6 included all assessments after first dose of chemotherapy up to the end of Cycle 6. Data exclused for participants taking drugs that affect platelet function or anticoagulants, from the time that the medication was started.|Screening, Day -5, Day 1 and 8 of Cycles 1 to 6 of 21-day cycle schedule, Day 1, 8 and 15 of cycles 1 to 6 of 28-day schedule, treatment withdrawal and 30-day follow-up|ITT Population: Participants with at least one visit within the cycle.||Participants|||Number
820822|NCT01147809|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase II|AE is any untoward medical occurrence temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a MP. For marketed MPs, this also includes failure to produce expected benefits, abuse, or misuse. SAE event is any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or, is a congenital anomaly/birth defect.|From first dose of investigational product (IP) until 30 days after discontinuation of IP (Longer for AEs related to study participation)|Safety Population||Participants|||Number
820823|NCT01147809|Secondary|Number of Participants With at Least One Delay in Their Scheduled Dose of Chemotherapy in Any Cycle in Phase I|Any delay in a scheduled dose of gemcitabine monotherapy or the combination of gemcitabine plus carboplatin or cisplatin was evaluated for eltrombopag and placebo treated participants.|All time on chemotherapy treatment|Safety Population||Participants|||Number
820824|NCT01147809|Secondary|Dose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase I|Dose intensity of chemotherapy is defined as the actual dose of chemotherapy given as a percentage of the scheduled C1D1/C1D8 dose, as applicable, within this study: Cycle Dose Intensity (%) = Total Actual dose (mg/m^2) within Cycle *100/ Total Scheduled dose (mg/m^2) in Cycle 1; wherein Actual Dose (mg/m^2) = Actual dose (mg)/Body Surface Area reported on electronic case report form (eCRF).|Cycle 1 to Cycle 6|Safety Population||Dose Intensity (%)||Standard Deviation|Mean
820825|NCT01147809|Secondary|Time to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase I, Estimated Using Central Laboratory Platelet Counts|Platelet nadir is defined within each cycle as the lowest platelet count reported after the Day 1 chemotherapy dose. Time to recovery (TR) (>100Gi/L or >150Gi/L) from platelet nadir is defined within each cycle as the time in days from the platelet nadir to the time at which platelet count returns to >=100Gi/L or >=150Gi/L within the same cycle or up to and including Day 1 of the next cycle. For the last cycle in the study, time to recovery was calculated in the same manner but up to and including any Conclusion/Early Withdrawal visit which has been assigned to the same cycle. For Group A, the chemotherapy cycle consisted of 21 days and for Group B, the chemotherapy cycle consisted of 28 days. Blood samples were collected to estimate platelet count at: Group A; Days 1, 4, 8, 15 and 17 of Cycles 1 to 6. Group B; Days 1, 4, 8, 15, 22, and 24 of Cycles 1 to 6. Only those participants available at indicated time points were analyzed (represented by n=X, X, X, X).|Cycle 1 to Cycle 6|Safety Population||Days||Standard Deviation|Mean
820826|NCT01147809|Secondary|Central Laboratory Platelet Count for Time Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase I|Platelet nadir is defined within each cycle as the lowest platelet count reported after the Day 1 chemotherapy dose. The time taken to reach platelet nadir is defined within each cycle. For Group A, the chemotherapy cycle consisted of 21 days and for Group B, the chemotherapy cycle consisted of 28 days. Blood samples were collected to estimate platelet nadir count at the following time points: Group A; Days 1, 4, 8, 15 and 17 of Cycles 1 to 6. Group B; Days 1, 4, 8, 15, 22 and 24 of Cycles 1 to 6. Only those participants available at indicated time points were analyzed (represented by n=X, X, X, X).|Cycle 1 to Cycle 6|Safety Population||Days||Standard Deviation|Mean
820827|NCT01147809|Secondary|Maximum Duration of Thrombocytopenia Across Cycles 2 to 6 in Phase I, Estimated Using Central Laboratory Platelet Counts|Duration of thrombocytopenia is defined as a period of time in days from the first report of a platelet count with NCI CTCAE Grade 1-4 until the first subsequent report of a platelet count no longer meeting those criteria, regardless of rescue medication usage. It was assessed between Day 1 of Cycle 2 and up to and including any Conclusion/Early Withdrawal visit assigned to the same cycle for participants completing up to 6 cycles, and between Day 1 of Cycle 2 and up to and including the end of Cycle 6 for participants continuing beyond 6 cycles. The chemotherapy cycle for Group A was 21 days and for Group B was 28 days. Blood samples were collected to estimate thrombocytes at the following time points: Group A; Days 1, 4, 8, 15 and 17 of Cycles 2 to 6. Group B; Days 1, 4, 8, 15, 22 and 24 of Cycles 2 to 6.|Cycle 2 to Cycle 6|Safety Population. Participants experiencing thrombocytopenia with subsequent increase in platelet count to >=150Gi/L are included.||Days||Standard Deviation|Mean
820828|NCT01147809|Secondary|Number of Participants With Thrombocytopenia of Grade 1, 2, 3 or 4 Across All the Chemotherapy Cycles in Phase I, Using Central Laboratory Platelet Count|As per the CTCAE version 4.0, par. with a platelet count <LLN but >=75 x 10^9/L (Gi/L) were considered to have Grade 1 thrombocytopenia; par. with a platelet count <75Gi/L, but >=50Gi/L were considered to have Grade 2 thrombocytopenia; par. with a platelet count <50Gi/L, but >=25Gi/L were considered to have Grade 3 thrombocytopenia and par. with a platelet count <25Gi/L were considered to have Grade 4 thrombocytopenia. Blood samples were collected to estimate thrombocytes at the following time points: For Group A, the chemotherapy cycle consisted of 21 days and for Group B, the chemotherapy cycle consisted of 28 days. Blood samples were collected to estimate thrombocytes at the following time points: Group A; Days 1, 4, 8, 15 and 17 of Cycles 1 to 6. Group B; Days 1, 4, 8, 15, 22 and 24 of Cycles 1 to 6. Par. experiencing thrombocytopenia (Platelets <150Gi/L) at least once within a cycle are presented in the category title as n=X,X,X,X.|Cycle 1 to Cycle 6|Safety Population||Participants|||Number
820829|NCT01147809|Secondary|Central Laboratory Average Daily Area Under the Curve Platelet-time Course Across Cycles 2 to 6 in Phase I|The average daily area under the platelet-time course was normalized by dividing the area under curve by total duration. This gives an estimated average platelet value over the time period from cycles 2 to 6. For 21-Day Cycle, the chemotherapy cycle consisted of 21 days and for 28-Day Cycle, the chemotherapy cycle consisted of 28 days. Blood samples were collected to estimate thrombocytes at the following time points: 21-Day Cycle; Days 1, 4, 8, 15 and 17 of Cycles 1 to 6. 28-Day Cycle; Days 1, 4, 8, 15, 22 and 24 of Cycles 1 to 6.|All assessments from Cycle 2 Day 1 to last assessment in Cycle 6|Safety Population||Giga (10^9) cells per liter (G cells/L)||Standard Deviation|Mean
820830|NCT01147809|Secondary|Platelet Count Nadir for Each Chemotherapy Cycle in Phase I|Platelet nadir is defined as the lowest platelet count (from central laboratory data) reported after the first dose of chemotherapy within each cycle. Platelet count nadir is defined for each cycle. For Group A, the chemotherapy cycle consisted of 21 days and for Group B, the chemotherapy cycle consisted of 28 days. Blood samples were collected to estimate platelet nadir count at the following time points: Group A; Days 1, 4, 8, 15 and 17 of Cycles 1 and 2, at Days 1, 4, 8, 15 and 17 of Cycle 3 to 6. Group B; Days 1, 4, 8, 15, 22 and 24 of Cycles 1 to 6. Only those participants available at indicated time points were analyzed (represented by n=X, X, X, X).|Cycle 1 to Cycle 6|Safety Population||Giga (10^9) cells per liter (G cells/L)||Standard Deviation|Mean
820831|NCT01147809|Secondary|Average Within-subject Central Laboratory Platelet Count Prior to Scheduled Chemotherapy Across Cycles 2 to 6 in Phase I|Within-subject platelet count for each participant was calculated by summing up the visit platelet counts from each of Cycles 1 to 6 and dividing it by the number of cycles in which the participant had data. The average within a treatment group was calculated by summing up the values from each participant within the treatment group and dividing it by the number of participants. These platelet counts are different from the pre-chemotherapy platelet counts for cycles where the chemotherapy dose was delayed. Average within-subject central laboratory platelet count prior to scheduled chemotherapy across Cycles 2 to 6 are summarized. Blood samples were collected on Days 1 and 8 of Cycles 2 to 6 for Group A and on Days 1, 8 and 15 from Cycles 2 to 6 for Group B to estimate the average within subject platelet count prior to scheduled chemotherapy. Only those participants available at the indicated time points were analyzed (represented by n=X,X,X,X in the category titles).|Day 1 (averaged across Cycles 2 to 6), Day 8 (averaged across Cycles 2 to 6)|Safety Population||Giga (10^9) cells per liter (G cells/L)||Standard Deviation|Mean
820832|NCT01147809|Secondary|Average Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase I|Pre-chemotherapy platelet count is defined for Cycle 1 as the platelet count (from central laboratory data) immediately preceding the first dose of chemotherapy within Cycle 1. For all subsequent cycles it is defined as the platelet count (from central laboratory data) immediately preceding, but limited to within 2 days prior to the first dose of chemotherapy at Day 1. For Group A, the chemotherapy cycle consisted of 21 days and for Group B, the chemotherapy cycle consisted of 28 days. Blood samples were collected to estimate platelet count at the following time points: Group A; Days 1 and 8 of Cycles 1 to 6. Group B; Days 1, 8 and 15 of Cycles 1 to 6. Only those participants available at indicated time points were analyzed (represented by n=X, X, X, X).|C1D1, C1D8, C1D15, C2D1, C2D8, C2D15, C3D1, C3D8, C3D15, C4D1,C4D8, C4D15, C5D1,C5D8, C5D15, C6D1,C6D8 and C6D15|Safety Population||Giga (10^9) cells per liter (G cells/L)||Standard Deviation|Mean
820833|NCT01147809|Primary|Mean Day 1 Scheduled Pre-chemotherapy Platelet Count Evaluated Across Cycles 1 to 6 in Phase II|Scheduled pre-chemotherapy platelet count is defined within each cycle as the platelet count assessment on which the decision to give or delay chemotherapy was made. This was averaged for each participant across Cycles 1 to 6 and a natural log transformation was applied to the average. The log-transformed values were compared between eltrombopag and placebo groups using an analysis of covariance (ANCOVA) model adjusting for cycle duration (21-day vs. 28-day), Baseline loge(platelet count) and part of study (part 1 or 2 of phase II). Only those participants available at indicated time points were analyzed (represented by n=X,X).|Day 1 (averaged across cycles 1 to 6)|Intent-to Treat (ITT) Population: all randomized participants.||Giga (10^9) cells per liter (Gi/L)||Geometric Coefficient of Variation|Geometric Mean
820834|NCT01147809|Primary|Number of Participants With Electrocardiogram (ECG) Findings at Anytime Post-Baseline in Phase I|A single safety 12-lead ECG was performed using a standard 12-lead ECG machine at screening and post-dose on C2D4. Three further ECGs were carried out at C2D8, C5D8 and C6D15. Change in ECG findings were categorized as 'Clinically significant change: favorable', 'No change or insignificant change' or 'Clinically significant change (CSC): unfavorable' as determined by the investigator. The Baseline value is defined as the value reported immediately prior to the administration of the first dose of chemotherapy in Cycle 1. Any time post-Baseline is defined by counting the participants under the worst result experienced post-Baseline. The best to worst order is 'Clinically significant change: favorable', 'No change or insignificant change', and then 'Clinically significant change (CSC): unfavorable. Only those participants available at the indicated time points were analyzed (represented by n=X,X,X,X in the category titles).|C2D4, C2D8, C5D8, C6D15|Safety Population||Participants|||Number
820888|NCT01147926|Secondary|Percent SBM With a Consistency of Normal and Hard/Very Hard|Consistency measured using the 7-point Bristol scale where 1-2 indicate constipation (=hard/very hard), 3-4 are ideal stools (=normal), and 5-7 tending toward diarrhea.|Over 12 week treatment period|mITT. Not all subjects in the mITT population had data for this outcome.||percentage of SBM||Standard Deviation|Mean
820835|NCT01147809|Primary|Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase I|ECOG-Zubrod scores for the performance status are defined as follows: Score 0: Fully active, 1: restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, 2: ambulatory and capable of all self-care but unable to carry out any work activities, 3: capable of only limited self-care, 4: completely disabled, 5: dead. The data is presented for the participants with the ECOG performance score at the indicated time points during the study.|Screening, C1D1, C2D1, C2D8, C2D15, C3D1, C4D1, C4D22, C5D1, C5D8, C6D1, C6D15|Safety Population||Participants|||Number
820836|NCT01147809|Primary|Number of Participants With a Change From Baseline in Creatinine of >=26.5 Micromoles/Liter (UMOL/L) in Phase I|The number of participants with at least 1 change from Baseline in creatinine, with an increase >=26.5 UMOL/L are reported. Creatinine clearance is estimated using the Cockcroft-Gault formula which is a method to approximate kidney function. The Baseline value is defined as the value reported immediately prior to the administration of the first dose of chemotherapy in Cycle 1.|After Baseline (C1D1), on-treatment and 30 day follow-up|Safety Population||Participants|||Number
820837|NCT01147809|Primary|Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase I|Clinical chemistry laboratory parameters with a related NCI CTCAE (version 4.0) toxicity grading were summarized by toxicity grade at each scheduled assessment. Clinical chemistry laboratory parameters included albumin (Alb), urea/blood urea nitrogen (BUN), creatinine, aspartate amino transferase (AST), alanine amino transferase (ALT), alkaline phosphatase (ALP), total bilirubin (TB), direct bilirubin (DB) and international normalized ratio/Prothrombin time (PT). The Baseline value is defined as the value reported immediately prior to the administration of the first dose of chemotherapy in Cycle 1. Post-Baseline is defined as any time after the first dose of chemotherapy in Cycle 1 up to and including all follow-up visits. Only those participants available at the indicated time points were analyzed (represented by n=X,X,X,X in the category titles).|After Baseline (C1D1), on-treatment and 30 day follow-up|Safety Population||Participants|||Number
820838|NCT01147809|Primary|Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase I|Hematology parameters with a related NCI CTCAE (version 4.0) toxicity grading were summarized by toxicity grade at each scheduled assessment, the maximum toxicity grade reached by a participant post-Baseline was summarized. Hematology parameters included hemoglobin (increased), hemoglobin (anemia), lymphocytes (increased), lymphocytes (decreased), total absolute neutrophil count (ANC), platelets (PLT) and white blood cells (WBC). The Baseline value is defined as the value reported immediately prior to the administration of the first dose of chemotherapy in Cycle 1. Post-Baseline is defined as any time after the first dose of chemotherapy in Cycle 1 up to and including all follow-up visits. Only those participant available at the indicated time points were analyzed (represented by n=X,X,X,X in the category titles).|After Baseline (C1D1), on-treatment and 30 day follow-up|Safety Population||Participants|||Number
820839|NCT01147809|Primary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase I|AEs are coded using the standard Medical Dictionary for Regulatory Activities (MedDRA) and were graded by the investigator according to National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE), version 4.0. AE is any untoward medical occurrence temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a MP. For marketed MPs, this also includes failure to produce expected benefits, abuse, or misuse. SAE event is any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or, is a congenital anomaly/birth defect.|From Cycle 1, Day 1 (C1D1) until at least 30 days post-investigational product discontinuation (longer for AEs considered related to study participation)|Safety Population||Participants|||Number
820840|NCT01147822|Secondary|Duration of Response (DOR)|DOR is defined as the time from the first documented evidence of confirmed response (CR or PR) until the first documented sign of disease progression (a >=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of >=1 new lesion) or death, if sooner. CR=the disappearance of all target lesions. Any pathological lymph node must be less than 10 mm in the short axis. PR=at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD.|From the time of response until the earliest date of disease progression/death (up to 38 months)|ITT Population (Asian). Only those participants who experienced either a confirmed CR or a PR were analyzed.||Months||95% Confidence Interval|Median
820841|NCT01147822|Secondary|Time to Response|Time to response is defined as the time from the start of treatment until the first documented evidence of confirmed CR (the disappearance of all target lesions. Any pathological lymph node must be less than 10 mm in the short axis) or PR (at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD), whichever comes first. CR and PR were evaluated by an independent review per RECIST, Version 1.|From Baseline until the time of response or the earliest date of disease progression/death (up to 39 months)|ITT Population (Asian). Only those participants who experienced either a confirmed CR or a PR were analyzed.||Weeks||95% Confidence Interval|Median
820842|NCT01147822|Secondary|Number of Participants With a Best Response of Confirmed Complete Response (CR) or Confirmed Partial Response (PR) as Assessed by the IRC|The number of participants with evidence of CR (the disappearance of all target lesions. Any pathological lymph node must be less than 10 millimeters [mm] in the short axis) or PR (at least a 30% decrease in the sum of the longest diameters [LD] of target lesions, taking as a reference the Baseline sum LD) was evaluated by an independent review per RECIST, Version 1.|From Baseline until the time of response or the earliest date of disease progression/death (up to 39 months)|ITT Population (Asian)||Participants|||Number
820843|NCT01147822|Secondary|Overall Survival (OS)|OS is defined as the time from randomization until death due to any cause. Participants who had not died were censored at the date of the last adequate tumor assessment at the time of the cut-off.|From randomization until death (up to 44 months)|ITT Population (Asian)||Months||95% Confidence Interval|Median
820889|NCT01147926|Secondary|SCBM Per Week||Over 12 week treatment period|mITT. Not all subjects in the mITT population had data for this outcome.||SCBM/week||Standard Deviation|Mean
820844|NCT01147822|Primary|Progression-free Survival (PFS)|PFS is defined as the interval between the date of randomization and the earliest date of progressive disease (PD), as defined by the Independent Review Committee (IRC), or death due to any cause. The IRC defined PD per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1. Per RECIST, PD is defined as a >=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter (LD) recorded since the treatment started or the appearance of >=1 new lesion. Participants who had neither progressed nor died were censored at the date of the last adequate tumor assessment at the time of the cut-off.|From randomization to the earliest date of disease progression or death (up to 39 months)|Intent-to-Treat (ITT) Population (Asian): All randomized participants (par) from Study VEG113078 and Study VEG108844 who enrolled in Japan, China, Taiwan, and Korea.||Months||95% Confidence Interval|Median
820845|NCT01147848|Other Pre-specified|Change From Baseline in EQ-5D Visual Analog Scale (VAS) Score at Day 168|"The EQ-5D is a standardized, 2-part, self-assessment instrument, designed for self-completion, used to measure health outcome. The first part consists of 5 items covering 5 dimensions (mobility, self care, usual activities, pain/discomfort, and anxiety/depression). The second part is a 20 centimeter VAS that has endpoints labelled best imaginable health state and worst imaginable health state anchored at 100 and 0, respectively. Participants were asked to indicate how they rate their own health by drawing a line from an anchor box to that point on the EQ-VAS that best represents their own health on that day. Analysis was performed using ANCOVA with covariates of Baseline VAS score, country, sex, age, and treatment."|Baseline and Day 168|ITT Population. Only those participants available at the indicated time point were assessed.||scores on a scale||Standard Error|Least Squares Mean
820846|NCT01147848|Other Pre-specified|"Percentage of Participants With No Problems in the EQ-5D Descriptive System Dimensions at Day 168/Week 24"|"The EQ-5D is a standardized, 2-part, self-assessment instrument, designed for self-completion, used to measure health outcome. The first part consists of 5 items covering 5 dimensions (mobility, self care, usual activities, pain/discomfort, and anxiety/depression). Each dimension is measured by a three-point Likert scale (1=no problems, 2=some problems and 3=severe problems). Respondents are asked to choose one level that reflects their own health state today for each of the five dimensions."|Day 168/Week 24|ITT Population. Only those participants available at the indicated time point were assessed.||percentage of participants|||Number
820847|NCT01147848|Other Pre-specified|Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Total Score for Participants 12 Years of Age and Older (AQLQ + 12)|"The AQLQ is a disease-specific, self-administered quality of life (QOL) questionnaire developed to evaluate the impact of asthma treatments on the QOL of asthma sufferers. The AQLQ contains 32 items in four domains: activity limitation (11 items), symptoms (12 items), emotional function (5 items), and environmental stimuli (4 items). The response format consists of a 7-point scale: a value of 1 indicates total impairment; a value of 7 indicates no impairment. The AQLQ total score is defined as the average of the scores from all 32 questions, provided at least 90% of the questions have been answered; thus, the total score ranges from 1 (indicates total impairment) to 7 (indicates no impairment). Change from Baseline was calculated as the Day 168 value minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline total AQLQ score, country, sex, age, and treatment."|Baseline and Day 168|ITT Population. Only those participants available at the indicated time point were assessed.||Scores on a scale||Standard Error|Least Squares Mean
820848|NCT01147848|Other Pre-specified|Number of Healthcare Contacts Related to Asthma or the Treatment of Asthma From Baseline to Day 168|All unscheduled asthma-related visits to a physician’s office, visits to urgent care, visits to the emergency department, and hospitalizations (to the general ward [GW] or the intensive care unit [ICU]) that were associated with asthma exacerbations were recorded.|Baseline to Day 168|ITT Population. Only those participants available at the indicated time point were assessed.||visits per participant||Standard Deviation|Mean
820849|NCT01147848|Other Pre-specified|Change From Baseline in Asthma Control Test (ACT) Scores at Day 168|"The ACT is a 5-item questionnaire developed as a measure of the participant's asthma control. Questions are designed to be self-completed by the participant and include the following: In the past 4 weeks, How much of the time did your asthma keep you from getting as much done at work, school or at home?, How often have you had shortness of breath?, How often did your asthma symptoms wake you up at night or earlier than usual in the morning?, How often have you used your rescue inhaler or nebulizer medication (such as albuterol)? and How would you rate your asthma control? The ACT total score is defined as the sum of the scores from all 5 questions, provided all questions have been answered; thus, the total score ranges from 5 (poor control of asthma) to 25 (complete control of asthma). A score of 20 or higher indicates well-controlled asthma. Change from Baseline was calculated as the Day 168 value minus the Baseline value."|Baseline and Day 168|ITT Population. Only those participants available at the indicated time point were assessed. Analysis was performed using ANCOVA with covariates of Baseline total ACT score, country, sex, age, and treatment.||Scores on a scale||Standard Error|Least Squares Mean
820850|NCT01147848|Other Pre-specified|Baseline FEV1 by Completion Status|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second . Baseline is defined as the mean of the two assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1.|Baseline|ITT Population. Only those participants available at the indicated time point were assessed.||Liters||Standard Deviation|Mean
820851|NCT01147848|Secondary|Change From Baseline in Trough FEV1 at Day 168|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second . Trough FEV1 is defined as the pre-dose measurement on Day 168/Week 24. Any missing data at Day 168/Week 24 was imputed using the last observation carried forward (LOCF). Baseline was the pre-dose measurement on Day 1. Change from Baseline was calculated as the pre-dose measurement on Day 168/Week 24 minus the Baseline value.|Baseline and Day 168|ITT Population. Only those participants available at the indicated time point were assessed.||Liters||Standard Error|Least Squares Mean
820852|NCT01147848|Secondary|Number of Participants Obtaining a >=12% and >=200 mL Increase From Baseline in FEV1|The number of participants obtaining a >=12% and >=200 mL increase from Baseline in FEV1 (the maximal amount of air that can be forcefully exhaled in one second) was evaluated at 12-hours post-dose and at 24-hours post-dose on Day 168.|Baseline and Day 168|ITT Population. Only those participants available at the indicated time points were assessed.||participants|||Number
820890|NCT01147926|Secondary|Percentage of Subjects With an Increase of at Least 1 SCBM Per Week||Over 12 week treatment period|mITT||percentage of subjects|||Number
820853|NCT01147848|Secondary|Change From Baseline in Weighted Mean Serial FEV1 Over 0-4 Hours at Day 168|The weighted mean serial FEV1 (the maximal amount of air that can be forcefully exhaled in one second) over 0-4 hours post-dose at Baseline and Day 168 was derived using actual times and using the pre-dose assessment as the 0 hour measurement. Change from Baseline was calculated as the weighted mean of the 4-hour serial FEV1 measures on Day 168/Week 24 minus the Baseline value. Baseline was the pre-dose measurement on Day 1. Analysis was performed using ANCOVA with covariates of Baseline FEV1, region, sex, age, and treatment.|Baseline and Day 168|ITT Population. Only those participants available at the indicated time point were assessed.||Liters||Standard Deviation|Mean
820854|NCT01147848|Secondary|Change From Baseline in Weighted Mean Serial FEV1 Over 0-4 Hours Post First Dose (at Randomization)|The weighted mean serial FEV1 (the maximal amount of air that can be forcefully exhaled in one second) over 0-4 hours post-dose at Baseline was derived using actual times and using the pre-dose assessment as the 0 hour measurement. Change from Baseline was calculated as the weighted mean of the 4-hour serial FEV1 measures on Day 1 minus the Baseline value. Baseline was the pre-dose measurement on Day 1. Analysis was performed using ANCOVA with covariates of Baseline FEV1, region, sex, age, and treatment.|Baseline and Randomization|ITT Population. Only those participants available at the indicated time point were assessed.||Liters||Standard Error|Least Squares Mean
820855|NCT01147848|Secondary|Number of Participants With the Indicated Time to Onset of Bronchodilator Effect at Day 1|Time to onset of bronchodilator effect at Day 1 is defined as the actual time during the 4-hour serial FEV1 (the maximal amount of air that can be forcefully exhaled in one second) measurements that the participant first meets or exceeds a 12% and 200 mL increase over Baseline and was derived at Day 1 only. Time to onset was calculated over 0 to 4 hours (5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, and 4 hours) post-dose. Participants who never exceeded a 12% and 200 mL increase over Baseline were censored at the actual time of their last FEV1 measurement.|Baseline to Day 1|ITT Population. Only those participants available at the indicated time points were assessed.||participants|||Number
820856|NCT01147848|Secondary|Serial FEV1 (0-24 Hours)|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second . The pre-dose FEV1 assessment and the individual serial FEV1 assessments at Day 168/Week 24 at the indicated time points (pre-dose, 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 11 hours, 12 hours, 12.5 hours, 13 hours, 14 hours, 16 hours, 20 hours, 23 hours, and 24 hour s) were summarized.|Day 168|ITT Population. Only those participants available at the indicated time points were assessed.||Liters||Standard Deviation|Mean
820857|NCT01147848|Primary|Change From Baseline in Weighted-mean 24 Hour Serial FEV1 on Day 168/Week 24|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. The weighted mean was calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5, 15, and 30 minutes (min) and at 1, 2, 3, 4, 11, 12, 12.5, 13, 14, 16, 20, 23, and 24 hours, respectively, on Day 168/Week 24. Change from Baseline was calculated as the weighted mean of the 24-hour serial FEV1 measures on Day 168/Week 24 minus the Baseline value. Baseline was the pre-dose measurement on Day 1. Analysis was performed using analysis of covariance (ANCOVA) with covariates of Baseline FEV1, region, sex, age, and treatment.|Baseline and Day 168/Week 24|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least 1 dose of double-blind medication. Randomized participants were assumed to have received double-blind medication unless definitive evidence to the contrary existed. Only those participants available at the indicated time point were assessed.||Liters||Standard Error|Least Squares Mean
820858|NCT01147874|Secondary|Percentage of Participants With Undiagnosed Psoriatic Arthritis (PsA)|PsA: inflammatory arthritis associated with psoriasis that can have an indolent and progressive course. Primary PsA diagnosis made by rheumatologist based on physical examination, medical history and laboratory test results. Secondary PsA diagnosis made by rheumatologist based on physical examination and medical history only. For both, numerator was number of participants with “No” answer to question concerning previous diagnosis of PsA at Visit 1 (dermatology visit) and were subsequently classified as positive by rheumatologist; denominator was total number of participants evaluated for PsA.|Week 0 through Week 8|FAS population included all randomized participants with an answer to the question at Visit 1 (dermatology visit) about previous diagnosis of PsA by a rheumatologist and had an assessment of PsA during the study by a rheumatologist based on medical history, physical examination and laboratory results.||Percentage of participants||95% Confidence Interval|Number
820859|NCT01147874|Secondary|Percentage of Participants With Psoriatic Arthritis (PsA) Based on Physical Examination and Medical History|PsA: inflammatory arthritis associated with psoriasis that can have an indolent and progressive course. Percentage of participants with PsA was calculated by dividing the number of participants who were classified as positive by the rheumatologist and the total number of participants evaluated using medical history and physical examination as the basis for the diagnosis.|Week 0 through Week 8|FAS population included all randomized participants with an answer to the question at Visit 1 (dermatology visit) about previous diagnosis of PsA by a rheumatologist and had an assessment of PsA during the study by a rheumatologist based on medical history, physical examination and laboratory results.||Percentage of participants||95% Confidence Interval|Number
820860|NCT01147874|Primary|Percentage of Participants With Psoriatic Arthritis (PsA) Based on Physical Examination, Medical History and Laboratory Results|PsA: inflammatory arthritis associated with psoriasis that can have an indolent and progressive course. Percentage of participants with PsA was calculated by dividing the number of participants who were classified as positive by the rheumatologist and the total number of participants evaluated using medical history, physical examination and laboratory results as the basis for the diagnosis.|Week 0 through Week 8|Full analysis set (FAS) population included all randomized participants with an answer to the question at Visit 1 (dermatology visit) about previous diagnosis of PsA by a rheumatologist and had an assessment of PsA during the study by a rheumatologist based on medical history, physical examination and laboratory results.||Percentage of participants||95% Confidence Interval|Number
820861|NCT01147900|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs).|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Year 8.5 up to study end (one month post Year 10 booster vaccination)|Analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of Boostrix™ vaccine, any formulation, for whom data were available.||subjects|||Number
820863|NCT01147900|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs).|An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any unsolicited AE = any unsolicited AE regardless of intensity or relationship to vaccination.|During the 31-day (Days 0-30) follow-up period after booster vaccination|Analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of Boostrix™ vaccine, any formulation, for whom data were available.||subjects|||Number
820864|NCT01147900|Secondary|Number of Subjects With Any Solicited General Symptoms.|Assessed solicited general symptoms were fatigue, gastrointestinal, headache and fever [defined as axillary temperature ≥ 37.5 degrees Celsius (°C)]. Any = incidence of a particular symptom regardless of intensity grade and relationship to vaccination.|During the 4-day (Days 0-3) follow-up period after booster vaccination|Analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of Boostrix™ vaccine, any formulation, for whom data were available.||subjects|||Number
820865|NCT01147900|Secondary|Number of Subjects With Any Solicited Local Symptoms.|Assessed solicited local symptoms were pain, redness and swelling at the injection site. Any = incidence of a particular symptom regardless of intensity grade.|During the 4-day (Days 0-3) follow-up period after booster vaccination|Analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of Boostrix™ vaccine, any formulation, for whom data were available.||subjects|||Number
820866|NCT01147900|Primary|Number of Booster Responders to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens.|"A booster responder to PT/PRN antigens was defined as either a vaccinated subject seronegative at analysis baseline (Year 10) with anti-PT/anti-PRN antibody concentration greater than or equal to (≥) 5 EL.U/mL at one month post Year 10 booster vaccination, or as a vaccinated subject seropositive at analysis baseline (Year 10) and with anti-PT/anti-PRN antibody concentration with at least a 2-fold increase at one month post Year 10 booster vaccination.
A seronegative/seropositive subject was defined as a vaccinated subject with anti-PT/anti-PRN antibody concentration ≥/< 5 EL.U/mL."|At 1 month post Year 10 booster vaccination|Analysis was done on the According-to-Protocol for immunogenicity at Year 10, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine, any formulation (at least 9.5 years after the dose administered in GSK263855/029 study) and for whom data concerning immunogenicity outcome measures were available.||subjects|||Number
820867|NCT01147900|Primary|Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies.|Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 5 EL.U/mL.|At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST)|Analysis was done on the According-to-Protocol for immunogenicity at Year 10, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine, any formulation (at least 9.5 years after the dose administered in GSK263855/029 study) and for whom data concerning immunogenicity outcome measures were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
820868|NCT01147900|Primary|Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies.|A seropositive subject for anti-PT/anti-PRN/anti-FHA antibodies was defined as a vaccinated subject who had anti-PT/anti-PRN/anti-FHA antibody concentrations greater than or equal to (≥) 5 ELISA units per milliliter (EL.U/mL).|At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST)|Analysis was done on the According-to-Protocol for immunogenicity at Year 10, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine, any formulation (at least 9.5 years after the dose administered in GSK263855/029 study) and for whom data concerning immunogenicity outcome measures were available.||subjects|||Number
820869|NCT01147900|Primary|Concentrations for Anti-D and Anti-T Antibodies.|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL for all antibodies assessed.|At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST)|Analysis was done on the According-to-Protocol for immunogenicity at Year 10, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine, any formulation (at least 9.5 years after the dose administered in GSK263855/029 study) and for whom data concerning immunogenicity outcome measures were available.||IU/mL||95% Confidence Interval|Geometric Mean
820870|NCT01147900|Primary|Number of Seroprotected Subjects Against Diphtheria and Tetanus|A subject seroprotected against diphtheria/tetanus was defined as a vaccinated subject who had an anti-D/anti-T antibody concentration greater than or above (≥) 0.1 international units per milliliter (IU/mL).|At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST)|Analysis was done on the According-to-Protocol for immunogenicity at Year 10, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine, any formulation (at least 9.5 years after the dose administered in GSK263855/029 study) and for whom data concerning immunogenicity outcome measures were available.||subjects|||Number
820871|NCT01147900|Primary|Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies.|Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 5 EL.U/mL.|At Year 10|The analysis was performed on the According To Protocol cohort for persistence at Year 10, which included all subjects who had received no additional dose of diphtheria, tetanus or pertussis vaccine other than the Boostrix™ booster dose received in the GSK263855/029 study, and for whom serological results were available at Year 10.||EL.U/mL||95% Confidence Interval|Geometric Mean
820872|NCT01147900|Primary|Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies.|A seropositive subject for anti-PT/anti-FHA/anti-PRN antibodies was defined as a vaccinated subject who had anti-PT/anti-FHA/anti-PRN antibody concentrations greater than or equal to (≥) 5 Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).|At Year 10|The analysis was performed on the According To Protocol cohort for persistence at Year 10, which included all subjects who had received no additional dose of diphtheria, tetanus or pertussis vaccine other than the Boostrix™ booster dose received in the GSK263855/029 study, and for whom serological results were available at Year 10.||subjects|||Number
821667|NCT01155063|Secondary|Number of Participants With Reasons for Discontinuation From Study Treatment||Month 0 up to Month 36 or early withdrawal|Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study.|||||
820873|NCT01147900|Primary|Concentrations for Anti-PT, Anti-PRN and Anti-FHA Antibodies.|Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 5 EL.U/mL for all antibodies assessed.|At Year 8.5|The analysis was performed on the According To Protocol cohort for persistence at Year 8.5 , which included all subjects who had received no additional dose of diphtheria, tetanus or pertussis vaccine other than the Boostrix™ booster dose received in the GSK263855/029 study, and for whom serological results were available at Year 8.5.||EL.U/mL||95% Confidence Interval|Geometric Mean
820874|NCT01147900|Primary|Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Haemagglutinin (Anti-FHA) Antibodies.|A seropositive subject for anti-PT/anti-PRN/anti-FHA antibodies was defined as a vaccinated subject who had anti-PT/anti-PRN/anti-FHA antibody concentrations greater than or equal to (≥) 5 Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).|At Year 8.5|The analysis was performed on the According To Protocol cohort for persistence at Year 8.5 , which included all subjects who had received no additional dose of diphtheria, tetanus or pertussis vaccine other than the Boostrix™ booster dose received in the GSK263855/029 study, and for whom serological results were available at Year 8.5.||subjects|||Number
820875|NCT01147900|Primary|Concentrations for Anti-D and Anti-T Antibodies.|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL.|At Year 10|The analysis was performed on the According To Protocol cohort for persistence at Year 10, which included all subjects who had received no additional dose of diphtheria, tetanus or pertussis vaccine other than the Boostrix™ booster dose received in the GSK263855/029 study, and for whom serological results were available at Year 10.||IU/mL||95% Confidence Interval|Geometric Mean
820876|NCT01147900|Primary|Number of Seroprotected Subjects Against Diphtheria and Tetanus.|A subject seroprotected against diphtheria/tetanus was defined as a vaccinated subject who had an anti-D/anti-T antibody concentration greater than or above (≥) 0.1 international units per milliliter (IU/mL).|At Year 10|The analysis was performed on the According To Protocol cohort for persistence at Year 10, which included all subjects who had received no additional dose of diphtheria, tetanus or pertussis vaccine other than the Boostrix™ booster dose received in the GSK263855/029 study, and for whom serological results were available at Year 10.||subjects|||Number
820877|NCT01147900|Primary|Concentrations for Anti-D and Anti-T Antibodies.|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL for all antibodies assessed.|At Year 8.5|The analysis was performed on the According To Protocol cohort for persistence at Year 8.5 , which included all subjects who had received no additional dose of diphtheria, tetanus or pertussis vaccine other than the Boostrix™ booster dose received in the GSK263855/029 study, and for whom serological results were available at Year 8.5.||IU/mL||95% Confidence Interval|Geometric Mean
820878|NCT01147900|Primary|Number of Seroprotected Subjects Against Diphtheria and Tetanus|A subject seroprotected against diphtheria/tetanus was defined as a vaccinated subject who had an anti-diphtheria (anti-D)/anti-tetanus (anti-T) antibody concentration greater than or above (≥) 0.1 international units per milliliter (IU/mL).|At Year 8.5|The analysis was performed on the According To Protocol cohort for persistence at Year 8.5, which included all subjects who had received no additional dose of diphtheria, tetanus or pertussis vaccine other than the Boostrix™ booster dose received in the GSK263855/029 study, and for whom serological results were available at Year 8.5.||subjects|||Number
820879|NCT01147926|Secondary|Percent of Subjects on the Subject Global Evaluation on Efficacy of Treatment Score Rating Treatment as Quite a Bit to Extremely Effective at Final On-Treatment Assessment|"The subject was asked to rate his global evaluation of the efficacy of treatment using the following 5-point scale:
0=not at all effective
a little bit effective
moderately effective
quite a bit effective
extremely effective."|Over 12 week treatment period|mITT. Not all subjects in the mITT population had data for this outcome.||percentage of subjects|||Number
820880|NCT01147926|Secondary|Percent of Subjects on the Subject Global Evaluation on Severity of Constipation Score Rating Constipation as Severe to Very Severe at Final On-Treatment Assessment|Subject was asked to rate the severity of his constipation using a 5-point Likert scale: 0=absent, 1=mild, 2=moderate, 3=severe, 4=very severe|Over 12 week treatment period|mITT. Not all subjects in the mITT population had data for this outcome.||percentage of subjects|||Number
820881|NCT01147926|Secondary|Percent of Subjects With an Improvement of ≥ 1 Point on the Patient Assessment of Constipation - Quality of Life (PAC-QOL) Total Score at Final On Treatment Assessment|The PAC-QOL is a validated 28-item questionnaire for the evaluation of quality of life in subjects with constipation. Items are rated on a 5-point Likert scale: 0=not at all/none of the time, 1=a little bit/a little bit of the time, 2=moderately/some of the time, 3=quite a bit/most of the time, 4=extremely/all of the time. Total score ranges from 0-112. Lower scores indicate improvement in symptoms. A 1-point improvement in PAC-QOL total score was considered clinically meaningful.|Over 12 week treatment period|mITT. Not all subjects in the mITT population had data for this outcome.||percentage of subjects|||Number
820882|NCT01147926|Secondary|Percent of Subjects With an Improvement of ≥ 1 Point on the Patient Assessment of Constipation – Symptom (PAC-SYM) Questionnaire Total Score at Final On Treatment Assessment|The PAC-SYM is a validated 12-item questionnaire for the evaluation of severity of symptoms of constipation in subjects with constipation. Items are rated on a 5-point Likert scale: 0=absent, 1=mild, 2=moderate, 3=severe, 4=very severe. Total score ranges from 0 to 48. Lower scores indicate improvement in symptoms. A 1-point improvement in PAC-SYM total score was considered clinically meaningful.|Over 12 week treatment period|mITT. Not all subjects in the mITT population had data for this outcome.||percentage of subjects|||Number
820883|NCT01147926|Secondary|Days With Rescue Medication Taken Per Week||Over 12 week treatment period|mITT. Not all subjects in the mITT population had data for this outcome.||Days/week||Standard Deviation|Mean
820884|NCT01147926|Secondary|Bisacodyl Tablets Taken Per Week||Over 12 week treatment period|mITT. Not all subjects in the mITT population had data for this outcome.||Tablets/week||Standard Deviation|Mean
820885|NCT01147926|Secondary|Time to First SCBM After Investigational Product Intake on Day 1||Day 1|mITT.||hours||95% Confidence Interval|Median
820886|NCT01147926|Secondary|Percent SBM With Sensation of Complete Evacuation||Over 12 week treatment period|mITT. Not all subjects in the mITT population had data for this outcome.||percentage of SBM||Standard Deviation|Mean
820892|NCT01147926|Primary|The Percentage of Subjects With an Average of ≥3 Spontaneous Complete Bowel Movements (SCBM) Per Week|Spontaneous Bowel Movements defined as a bowel movement that is not preceded within a period of 24 hours by the intake of a laxative agent or by the use of an enema.|Over 12 week treatment period|Modified Intent-to-treat Population (mITT) included all subjects randomized into the study except those excluded due to a major good clinical practice (GCP) breach at one site, who took at least 1 dose of the investigational product.||percentage of subjects|||Number
820893|NCT01149057|Secondary|Change From Baseline in Health Assessment Questionnaire (HAQ) at Weeks 24, 48, 72, and 96|HAQ: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline; Weeks 24, 48, 72 and 96|ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies the number participants with available data for specified category.||units on a scale||Standard Deviation|Mean
820894|NCT01149057|Secondary|Participant Assessment of Pain (VAS)|"The mean score of pain as assessed by participants using a 100-mm horizontal VAS, where the left endpoint (0) indicated No pain, and the right endpoint (100) indicated Unbearable pain. Higher score indicated higher pain."|Baseline; Weeks 8, 16, 24, 36 48, 72 and 96|ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies the number participants with available data for specified category.||mm||Standard Deviation|Mean
820895|NCT01149057|Secondary|Erythrocyte Sedimentation Rate||Baseline; Weeks 8, 16, 24, 36 48, 72 and 96|ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies the number participants with available data for specified category.||millimeter per hour||Standard Deviation|Mean
820896|NCT01149057|Secondary|C-reactive Protein Level||Baseline; Weeks 8, 16, 24, 36 48, 72 and 96|ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies the number participants with available data for specified category.||milligram per deciliter||Standard Deviation|Mean
820897|NCT01149057|Secondary|Change From Baseline in Hemoglobin at Weeks 20, 44, 72 and 96||Baseline; Weeks 20, 44, 72 and 96|ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies the number participants with available data for specified category.||gram per deciliter||Standard Deviation|Mean
820898|NCT01149057|Secondary|Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50 and ACR70 Response at Weeks 24, 48, 72, and 96|ACR20 response: ≥20% improvement in TJC; ≥20% improvement in SJC; and ≥20% improvement in at least 3 of 5 remaining ACR core measures: Patient Assessment of Pain; Patient Global Assessment of Disease Activity (PtGA); Physician Global Assessment of Disease Activity (PGA); self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ-DI]); and either CRP or ESR. ACR50 response required ≥50% improvement in the above criteria and ACR70 response required ≥70% improvement in the above criteria.|Weeks 24, 48, 72 and 96|ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies the number participants with available data for specified category.||percentage of partcipants|||Number
820899|NCT01149057|Secondary|Change From Baseline in SJC At Weeks 24, 48, 72, and 96|66 joints were assessed for swelling and joints are classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66. A negative change from baseline indicated improvement.|Baseline; Weeks 24, 48, 72 and 96|ITT population. Here, 'n' signifies the number of participants with available data at specified timepoints.||swollen joints||Standard Deviation|Mean
820900|NCT01149057|Primary|Change From Baseline in FACIT Fatigue Score at Week 96 in PP Population|The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score).|Baseline, Week 96|Per Protocol (PP) population. Number of participants analyzed=participants with available data for specified time point.||units on a scale||Standard Deviation|Mean
820901|NCT01149057|Primary|Change From Baseline in FACIT Fatigue Score at Week 72 in PP Population|The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score).|Baseline, Week 72|Per Protocol (PP) population. Number of participants analyzed=participants with available data for specified time point.||units on a scale||Standard Deviation|Mean
820902|NCT01149057|Primary|Change From Baseline in FACIT Fatigue Score at Week 48 in PP Population|The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score).|Baseline, Week 48|Per Protocol (PP) population. Number of participants analyzed=participants with available data for specified time point.||units on a scale||Standard Deviation|Mean
820955|NCT01149473|Primary|AUC0-inf of Hydrochlorothiazide(Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on Hydrochlorothiazide AUC0-inf.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
820903|NCT01149057|Primary|Change From Baseline in FACIT Fatigue Score at Week 24 in Per Protocol (PP) Population|The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score).|Baseline, Week 24|Per Protocol (PP) population: all participants who completed the study. Number of participants analyzed=participants with available data for this outcome. Here 'n' signifies the participants with available data for specified time point.||units on a scale||Standard Deviation|Mean
820904|NCT01149057|Primary|Change From Baseline in FACIT Fatigue Score at Week 96 in ITT Population|The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score).|Baseline, Week 96|ITT population. Number of participants analyzed=participants with available data at specified time point.||units on a scale||Standard Deviation|Mean
820905|NCT01149057|Primary|Change From Baseline in FACIT Fatigue Score at Week 72 in ITT Population|The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score).|Baseline, Week 72|ITT population. Number of participants analyzed=participants with available data at specified time point.||units on a scale||Standard Deviation|Mean
820906|NCT01149057|Primary|Change From Baseline in FACIT Fatigue Score at Week 48 in ITT Population|The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score).|Baseline, Week 48|ITT population. Number of participants analyzed=participants with available data at specified time point.||units on a scale||Standard Deviation|Mean
820907|NCT01149057|Secondary|Change From Baseline in TJC At Weeks 24, 48, 72, and 96|68 joints are assessed for tenderness and joints are classified as tender/not tender giving a total possible tender joint count score of 0 to 68. A negative change from baseline indicated improvement.|Baseline; Weeks 24, 48, 72 and 96|ITT population. Here, 'n' signifies the number of participants with available data at specified timepoints.||tender joints||Standard Deviation|Mean
820908|NCT01149057|Secondary|Percentage of Participants Achieving Remission and Low Disease Activity According to Clinical Disease Activity Index (CDAI) at Weeks 24, 48, 72, and 96|CDAI was calculated by a simple numerical sum of tender and swollen joint count (based on 28-joint assessment) and the patient and physician global disease assessment (VAS 0-10 cm). CDAI total score 0-76; higher scores = greater effect due to disease activity. Remission was defined as CDAI score ≤2.8. Low disease activity was defined as CDAI score ≤10.0.|Weeks 24, 48, 72 and 96|ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies number of participants with available data for specified category.||percentage of participants|||Number
820909|NCT01149057|Secondary|Percentage of Participants Achieving Remission and Low Disease Activity According to Simplified Disease Activity Index (SDAI) at Weeks 24, 48, 72, and 96|SDAI was calculated by a simple numerical sum of tender and swollen joint count (based on a 28-joint assessment), patient and physician global assessment of disease activity (VAS 0-10 centimeter [cm]), and level of CRP. SDAI total score 0-86; higher scores = greater effect due to disease activity. Remission was defined as SDAI score ≤3.3. Low disease activity was defined as SDAI score ≤11.0.|Weeks 24, 48, 72 and 96|ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies number of participants with available data for specified category.||percentage of participants|||Number
820910|NCT01149057|Secondary|Percentage of Participants With DAS28 Good or Moderate European League Against Rheumatism (EULAR) Response at Weeks 24, 48, 72 and 96|The DAS28 score was a measure of the participant's disease activity calculated using the TJC [28 joints], SJC [28 joints], patient's global assessment of disease activity (VAS: 0=no disease activity to 100=maximum disease activity) and the ESR for a total possible score of 0 to approximately 10. In case of missing ESR value, CRP was used to calculate DAS28. Higher scores represented higher disease activity. EULAR Good response: DAS28 ≤3.2 and a change from Baseline <-1.2. EULAR Moderate response: DAS28 greater than (>) 3.2 to less than or equal to (≤) 5.1 or a change from Baseline <-0.6 to greater than or equal to (≥) -1.2.|Weeks 24, 48, 72 and 96|ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies number of participants with available data for specified category.||percentage of participants|||Number
820911|NCT01149057|Secondary|Percentage of Participants Achieving Remission According to DAS28 at Weeks 24, 48, 72, and 96|Remission was defined as DAS28 score <2.6. The DAS28 score was a measure of the participant's disease activity calculated using the TJC [28 joints], SJC [28 joints], patient's global assessment of disease activity (VAS: 0=no disease activity to 100=maximum disease activity) and the ESR for a total possible score of 0 to approximately 10. In case of missing ESR value, CRP was used to calculate DAS28. Higher scores represented higher disease activity.|Weeks 24, 48, 72 and 96|ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies number of participants with available data for specified category.||percentage of participants|||Number
820912|NCT01149057|Secondary|Number of Participants Achieving Remission According to Disease Activity Score 28 (DAS28) at Weeks 24, 48, 72, and 96|Remission was defined as DAS28 score less than (<) 2.6. The DAS28 score was a measure of the participant's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity (visual analog scale [VAS]: 0=no disease activity to 100=maximum disease activity) and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. In case of missing ESR value, C-Reactive Protein (CRP) was used to calculate DAS28. Higher scores represented higher disease activity.|Weeks 24, 48, 72 and 96|ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies the number participants with available data for specified category.||participants|||Number
820913|NCT01149057|Secondary|Change From Baseline in Bone Mineral Density (BMD) in Lumbar Spine, Total Hip and Femoral Neck Regions at End of Study|BMD was measured by dual energy X-ray absorptiometry (DXA) and T-scores (a standard deviation [SD] compared with the peak BMD value of an adult aged from 20 to 30 years) were calculated. Osteopenia was defined by a T-score between -1 and -2.5 SD and osteoporosis as a T-score below -2.5 SD, according to the World Health Organization (WHO) guidelines. T-scores for L1-L4 lumbar spine, total spine, total hip (left), and femoral neck (left) were calculated.|Baseline, End of the study (up to Week 100)|ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies the number of participants with available data for specified category.||T-score||Standard Deviation|Mean
820914|NCT01149057|Primary|Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score at Week 24 in Intent-to-treat (ITT) Population|The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score).|Baseline, Week 24|ITT population. Number of participants analysed=participants with available data for this endpoint. Here, 'n' signifies participants with available data at specified time point.||units on a scale||Standard Deviation|Mean
820915|NCT01149148|Primary|Mini Mental State Examination (MMSE)|"The Mini–Mental State Examination (MMSE) or Folstein test is a brief 30-point questionnaire test that is used to screen for cognitive impairment. It is also used to estimate the severity of cognitive impairment at a specific time and to follow the course of cognitive changes in an individual over time, thus making it an effective way to document an individual's response to treatment. MMSE = Mini Mental State Exam - measures general orientation and mental status.
Scores on a scale range from 0 - 30. Scores 23 and below are indicative of problems."|3 Months|Not all participants completed 3 month follow up neurocognitive testing.||Scores on a scale||Standard Deviation|Mean
820916|NCT01149148|Primary|Mini Mental State Examination (MMSE)|"The Mini–Mental State Examination (MMSE) or Folstein test is a brief 30-point questionnaire test that is used to screen for cognitive impairment. It is also used to estimate the severity of cognitive impairment at a specific time and to follow the course of cognitive changes in an individual over time, thus making it an effective way to document an individual's response to treatment. MMSE = Mini Mental State Exam - measures general orientation and mental status.
Scores on a scale range from 0 - 30. Scores 23 and below are indicative of problems."|Baseline|||scores on a scale||Standard Deviation|Mean
820917|NCT01149421|Secondary|Measurement of LY2189265 Drug Concentration for Pharmacokinetics - Area Under the Concentration Time Curve (AUC)|The population mean estimates and standard deviations were calculated for pharmacokinetic parameters (area under the concentration time curve [AUC] at steady state from time zero to 168 hours after study drug administration). Evaluable pharmacokinetic concentrations from the 4, 8, 12, 16, and 26 weeks timepoints were combined and utilized in a population approach to determine the population mean estimate and standard deviation at steady-state.|4, 8, 12, 16, and 26 weeks|Participants who received at least one dose of LY2189265 with evaluable LY2189265 concentration data.||nanograms*hour per liter (ng*h/L)||Standard Deviation|Mean
820918|NCT01149421|Secondary|Change From Baseline to 16 and 26 Weeks in Body Weight|Least Squares (LS) means was calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.|Baseline, 16 and 26 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable body weight data.||kilogram (kg)||Standard Error|Least Squares Mean
820919|NCT01149421|Secondary|Rate of Hypoglycemic Episodes|Hypoglycemic events (HE) were classified as severe (defined as an HE requiring assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as an HE with typical symptoms of hypoglycemia and a blood glucose level of ≤3.9 millimoles per liter [mmol/L]), asymptomatic (defined as an HE without typical symptoms of hypoglycemia but with a measured blood glucose of ≤3.9 mmol/L), nocturnal (defined as any HE occurring between bedtime and waking with a measured blood glucose of ≤3.9 mmol/L), or non-nocturnal. Hypoglycemia rate per 30 days was summarized at each visit by treatment group. The rate of hypoglycemia was analyzed using a generalized estimation equations model with a negative binomial distribution and a Logit link. Negative binomial mean was adjusted by treatment, visit, and visit by treatment interaction. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline, 16 and 26 weeks|Participants who received at least one dose of LY2189265 or Placebo.||events per participant per 30 days||Standard Deviation|Mean
820920|NCT01149421|Secondary|Anti-LY2189265 Antibodies|LY2189265 anti-drug antibodies (ADA) were assessed at baseline, 16 and 26 weeks, and at the safety follow-up visit 4 weeks after study drug discontinuation (30 weeks). The number of participants with initial postbaseline detection of treatment-emergent (defined as a 4-fold increase in the ADA titer from baseline) anti-drug (LY2189265) ADA at each time point were summarized.|Baseline, 16, 26, and 30 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable anti-drug (LY2189265) antibodies (ADA) data.||participants|||Number
820956|NCT01149473|Primary|AUC0-t of Hydrochlorothiazide(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on Hydrochlorothiazide AUC0-t.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
820921|NCT01149421|Secondary|Number of Participants With Adjudicated Cardiovascular Events up to 26 Weeks|Deaths and nonfatal cardiovascular adverse events (AEs) were adjudicated by a committee of physicians with cardiology expertise external to the Sponsor. The nonfatal cardiovascular AEs to be adjudicated include myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions (such as coronary artery bypass graft or percutaneous coronary intervention), and cerebrovascular events including cerebrovascular accident (stroke) and transient ischemic attack. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 weeks|Participants who received at least one dose of LY2189265 or Placebo.||participants|||Number
820922|NCT01149421|Secondary|Number of Events of Adjudicated Pancreatitis up to 26 Weeks|The number of adjudicated (by an independent Clinical Endpoint Committee [CEC]) pancreatic events is summarized at 26 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 weeks|Participants who received at least one dose of LY2189265 or Placebo.||events|||Number
820923|NCT01149421|Secondary|Change From Baseline to 16 and 26 Weeks on Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. PR is the interval between the P wave and the QRS complex. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.|Baseline, 16 and 26 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable Fridericia-corrected QT (QTcF) or PR interval change from baseline data.||milliseconds (msec)||Standard Error|Least Squares Mean
820924|NCT01149421|Secondary|Change From Baseline to 16 Weeks in High-Sensitivity C-Reactive Protein (Hs-CRP)||Baseline, 16 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable High-Sensitivity C-Reactive Protein (hs-CRP) data.||milligram per liter (mg/L)||Standard Deviation|Mean
820925|NCT01149421|Secondary|Change From Baseline to 16 and 26 Weeks on Serum Calcitonin||Baseline, 16 and 26 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable serum calcitonin data.||picograms per milliliter (pg/mL)||Standard Deviation|Mean
820926|NCT01149421|Secondary|Change From Baseline to 16 and 26 Weeks on Pancreatic Enzymes|Amylase (total and pancreas-derived) and lipase concentrations were measured.|Baseline, 16 and 26 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable pancreatic enzyme data.||units per liter||Inter-Quartile Range|Median
820927|NCT01149421|Secondary|Number of Participants With Treatment Emergent Adverse Events at 26 Weeks|A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with one or more TEAE is summarized cumulatively at 26 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 weeks|Participants who received at least one dose of LY2189265 or Placebo.||participants|||Number
820928|NCT01149421|Secondary|Percentage of Participants Achieving an Glycosylated Hemoglobin (HbA1c) of <7% or ≤6.5%|Percentages of participants who achieved glycosylated hemoglobin (HbA1c) levels of <7% or ≤6.5% were analyzed with Chi-squared test/Fisher’s exact test.|Baseline and 16 and 26 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable glycosylated hemoglobin (HbA1c) data.||percentage of participants|||Number
820929|NCT01149421|Secondary|Change From Baseline to 16 and 26 Weeks in Fasting Blood Glucose (FBG)|Fasting blood glucose (FBG) is a test to determine how much glucose (sugar) is in a blood sample after an overnight fast. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.|Baseline, 16 and 26 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable fasting blood glucose data.||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
820930|NCT01149421|Secondary|Change From Baseline to 16 and 26 Weeks in Glycosylated Hemoglobin (HbA1c)|Glycosylated hemoglobin (HbA1c) is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.|Baseline, 16 and 26 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable glycosylated hemoglobin (HbA1c) data.||percentage of HbA1c||Standard Error|Least Squares Mean
820931|NCT01149421|Secondary|Change From Baseline to 16 and 26 Weeks in Mean Daytime and Nighttime Mean Arterial Pressure (MAP)|Mean daytime and nighttime mean arterial pressure (MAP) was measured by a using 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant’s nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.|Baseline, 16 and 26 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable mean arterial pressure data.||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
820957|NCT01149473|Primary|Cmax of Hydrochlorothiazide(Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Hydrochlorothiazide Cmax.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
820958|NCT01149473|Primary|AUC0-inf of Losartan(Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on Losartan AUC0-inf.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
821668|NCT01155063|Secondary|Percentage of Participants Who Discontinued the Study Medication||Month 0 up to Month 36 or early withdrawal|Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study.|||||
820932|NCT01149421|Secondary|Change From Baseline to 16 and 26 Weeks in Mean Daytime and Nighttime Pulse Pressure|Mean daytime and nighttime pulse pressure (PP) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant’s nondominant arm. Pulse pressure (PP) measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.|Baseline, 16 and 26 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable pulse pressure data.||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
820933|NCT01149421|Secondary|Change From Baseline to 16 and 26 Weeks in Mean Daytime, Nighttime, and Clinic Heart Rate (HR)|Daytime and nighttime heart rate (HR) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant’s nondominant arm. Heart rate measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension. Clinic HR was measured in the clinic using the Omron HEM 907XL Blood Pressure monitor.|Baseline, 16 and 26 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable heart rate data.||beats per minute (bpm)||Standard Error|Least Squares Mean
820934|NCT01149421|Secondary|Change From Baseline to 16 and 26 Weeks in Mean Daytime, Nighttime, and Clinic Diastolic Blood Pressure (DBP)|Mean daytime and nighttime diastolic blood pressure (DBP) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant’s nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means of change from baseline was analyzed using mixed model repeated measures (MMRM) adjusted by baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension. Clinic DBP was measured in the clinic using the Omron HEM 907XL Blood Pressure monitor.|Baseline, 16 and 26 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable diastolic blood pressure data.||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
820935|NCT01149421|Secondary|Change From Baseline to 16 and 26 Weeks in Mean Daytime, Nighttime, and Clinic Systolic Blood Pressure (SBP)|Mean daytime and nighttime systolic blood pressure (SBP) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant’s nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension. Clinic SBP was measured in the clinic using the Omron HEM 907XL Blood Pressure monitor.|Baseline, 16 and 26 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable systolic blood pressure data.||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
820936|NCT01149421|Secondary|Change From Baseline to 16 and 26 Weeks in Mean 24-hour Mean Arterial Pressure (MAP)|Mean 24-hour mean arterial pressure (MAP) was measured by a using 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.|Baseline, 16 and 26 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable mean arterial pressure data.||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
820937|NCT01149421|Secondary|Change From Baseline to 16 and 26 Weeks in Mean 24-hour Pulse Pressure|Mean 24-hour pulse pressure (PP) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Pulse pressure (PP) measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.|Baseline, 16 and 26 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable pulse pressure data.||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
820938|NCT01149421|Secondary|Change From Baseline to 16 and 26 Weeks in Mean 24-Hour Heart Rate (HR)|Mean 24-hour heart rate (HR) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Heart rate measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.|Baseline, 16 and 26 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable heart rate data.||beats per minute (bpm)||Standard Error|Least Squares Mean
821744|NCT01155180|Primary|Percent Change From Baseline in Body Weight at 6 Months|Body weight was recorded to the nearest 0.1 kg at baseline and at 6 months after randomization. Then the percentage change was calculated.|baseline and 6 months after randomization|||percentage change||Standard Error|Mean
820939|NCT01149421|Secondary|Change From Baseline to 16 and 26 Weeks in Mean 24-hour Diastolic Blood Pressure (DBP)|Mean 24-hour diastolic blood pressure (DBP) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means of change from baseline was analyzed using mixed model repeated measures (MMRM) adjusted by baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.|Baseline, 16 and 26 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable diastolic blood pressure data.||millimeters of mercury (mmHg)]||Standard Error|Least Squares Mean
820940|NCT01149421|Secondary|Change From Baseline to 26 Weeks in Mean 24-hour Systolic Blood Pressure (SBP)|Mean 24-hour systolic blood pressure (SBP) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant’s nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.|Baseline, 26 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable systolic blood pressure data.||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
820941|NCT01149421|Primary|Change From Baseline to 16 Weeks in Mean 24-hour Systolic Blood Pressure (SBP)|Mean 24-hour systolic blood pressure (SBP) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant’s nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.|Baseline, 16 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable blood pressure data.||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
820942|NCT01149434|Secondary|Safety and Tolerability of JI-101|Number of patients experiencing a grade 2 or higher Adverse Event related to JI101|2 years|||Participants|||Number
820943|NCT01149434|Primary|Tumor Response in the Ovarian Cancer Cohort|Response Rate determined by the sum of patients achieving complete or partial response to JI-101 as defined by Response Evaluation Criteria in Solid Tumors|2 years|The intent of this trial was to analyze three different cohorts of patients with different diagnosis. This analysis was conducted with 8 of the enrolled patients that had ovarian disease. The number of patients enrolled on the remaining cohorts were not included in this analysis.||Participants|||Number
820944|NCT01149434|Primary|Progression Free-Survival in the Ovarian Cancer Cohort|progression-free survival at 2 months. We define progression as using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), to detect a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|2 months|The intent of this trial was to analyze three different cohorts of patients with different diagnosis. This analysis was conducted with 8 of the enrolled patients that had ovarian disease. Patients enrolled on the remaining cohorts were excluded in this analysis. Results were calculated using Kaplan-Meier product limit methods.||percentage of participants||95% Confidence Interval|Number
820945|NCT01149434|Secondary|Tumor Response|Response Rate determined by the sum of patients achieving complete or partial response to JI-101 as defined by Response Evaluation Criteria in Solid Tumors. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|2 years|||participants|||Number
820946|NCT01149434|Secondary|Safety and Tolerability of JI-101|Number of patients experiencing a grade 2 or higher Adverse Event related to JI101|2 years|||participants|||Number
820947|NCT01149434|Primary|Effect of RAD001 on Pharmacokinetics AUC(0-inf) of JI-101|Determine the mean percent change that RAD001 has on the peak concentration as determined by calculating the AUC (0-inf) of JI101 in the presence and absence of RAD001|pre-dose and at 0.5, 1, 2, 4, 6, 8, 10, and 24 hours after dosing (Cycle 1 Day 8 for RAD001 + JI101 and Cycle 1 Day 15 for JI-101 alone|||percentage change||Full Range|Mean
820948|NCT01149434|Primary|Effect of JI 101 on Pharmacokinetics Area Under Curve (AUC) (0-inf) of RAD001|Determine the mean percent change that JI-101 has on the peak concentration as determined by calculating the AUC (0-inf) of RAD001 in the presence and absence of JI-101|pre-dose and at 0.5, 1, 2, 4, 6, 8, 10, and 24 hours after dosing (Cycle 1 Day 1 for RAD001 alone and Cycle 1 Day 8 for RAD001 + JI-101|||percentage change||Full Range|Mean
820949|NCT01149460|Secondary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) - Acyclovir||Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
820950|NCT01149460|Secondary|AUC0-t (Area Under Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) - Acyclovir||Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
820951|NCT01149460|Secondary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma) - Acyclovir||Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
820952|NCT01149460|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) - Valacyclovir|Bioequivalence based on AUC0-inf|Blood samples collected over 12 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
821745|NCT01155219|Primary|Ocular Tolerance|Response defined as a combination of satisfactory or acceptable effect on IOP and a reduction of at least 20% of the total tolerance score in the worse eye.|Day 84|Full Analysis Set||participants|||Number
820959|NCT01149473|Primary|AUC0-t of Losartan(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on Losartan AUC0-t.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
820960|NCT01149473|Primary|Cmax of Losartan(Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Losartan Cmax.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
820961|NCT01149486|Secondary|AUC0-inf of Losartan Carboxy Acid(Area Under the Concentration-time Curve From Time Zero to Infinity)|Informational comparison of AUC0-inf values for the metabolite Losartan Carboxy Acid.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
820962|NCT01149486|Secondary|AUC0-t of Losartan Carboxy Acid(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Informational comparison of AUC0-t values for the metabolite Losartan Carboxy Acid.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
820963|NCT01149486|Secondary|Cmax of Losartan Carboxy Acid(Maximum Observed Concentration of Drug Substance in Plasma)|Informational comparison of Cmax values for the metabolite Losartan Carboxy Acid.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
820964|NCT01149486|Primary|AUC0-inf of Hydrochlorothiazide(Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on Hydrochlorothiazide AUC0-inf.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
820965|NCT01149486|Primary|AUC0-t of Hydrochlorothiazide(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on Hydrochlorothiazide AUC0-t.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
820966|NCT01149486|Primary|Cmax of Hydroclorothiazide(Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Hydrochlorothiazide Cmax.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
820967|NCT01149486|Primary|AUC0-inf of Losartan(Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on Losartan AUC0-inf.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
820968|NCT01149486|Primary|AUC0-t of Losartan(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on Losartan AUC0-t.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
820969|NCT01149486|Primary|Cmax of Losartan(Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Losartan Cmax.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
820970|NCT01149512|Secondary|% of Excess Body Weight Loss|the percent of excess body weight loss between Baseline and 1 year the percent of excess body weight loss between Baseline and 2 years the percent of excess body weight loss between Baseline and 3 years|baseline to 1 year, baseline to 2 years, baseline to 3 years|3 not included the same reason as above.||% of excessive weight loss||Standard Deviation|Mean
820971|NCT01149512|Primary|Mean Percentage Total Body Weight Loss|the percent total body weight loss between Baseline and 1 year the percent total body weight loss between Baseline and 2 years the percent total body weight loss between Baseline and 3 years|baseline to 1 year, baseline to 2 years, baseline to 3 years|Three patients’ weight data were not included in the weight loss analysis owing to early removal of band (n = 1) and complication or pregnancy affecting weight (n = 2) before 1-year follow-up. 79 patients reached 2 year follow up time point and 38 patients reached 3 year follow up time point.||% of total body weight loss||Standard Deviation|Mean
820972|NCT01149538|Secondary|Evoked Response Potential - Negative Component Latency|Evoked Response Potential - negative component latency data are included.|Baseline, 6 months, and 9 months|Children with FASD who were administered Evoked Response Potential test and provided usable data (choline and placebo arms)||Milliseconds||Standard Deviation|Mean
820973|NCT01149538|Secondary|Evoked Response Potentials Microvolts|Evoked response potentials were measured for the memory task. Frontal positive slow-wave potential negative component amplitude data are included.|Baseline, 6 months, and 9 months|Children with FASD who were administered Evoked Response Potential test and provided usable date (choline and placebo arms)||Mircovolts||Standard Deviation|Mean
820974|NCT01149538|Secondary|Elicited Imitation Task Memory|The Elicited Imitation (EI) paradigm (P.J. Bauer, 1989, Dev. Psychology) was used to measure memory in the participants at baseline, 6 months, and 9 months. The measures were items recalled after a delay (delayed items) and pairs of items recalled after a delay (delayed pairs). The sample was split by age in the analysis (young vs. old) as reflected in the outcome data. Outcome data measures included here are the slopes of the regression lines reflecting change over the three timepoints, controlling for immediate memory performance on the EI task.The slopes are given, as opposed to the raw scores, because these were the values used in the growth curve analyses. Details of these analyses are included in Wozniak et al. (2015) AJCN, doi:10.3945/ajcn.114.099168. NOTE that the means presented below represent the simple slopes that estimate the change in task performance (% of items correct) per 6-month unit of time. To estimate change in task performance over 9 months, multiply by 1.5.|Baseline, 6 months, and 9 months|Young choline group (n=17); Young placebo group (n=13); Old choline group (n=14); Old placebo group (n=16).||Slope||Standard Error|Mean
820975|NCT01149538|Primary|Mullen Scales of Early Learning - Early Learning Composite|The Mullen Scales of Early Learning is a measure of global cognitive development and is a primary outcome measure. The Early Learning Composite is the total score for this measure. It is a scaled score with a mean of 100 and a standard deviation of 15 (higher scores indicate better global cognitive status; average range is 85-115; Impaired range is 70 or below; full range is typically 50 - 150, although minimum and maximum scores are dependent on age). See the Mullen Scales reference manual for more psychometric details.|Baseline and 9 months|Including those with partial completion (drop-outs and lost-to-followup).||units on a scale||Standard Deviation|Mean
820976|NCT01149538|Primary|Side Effects of Choline Bitartrate|Side effects of choline bitartrate will be monitored by the study physician and the P.I. with physical examinations and telephone contact.|Baseline, 6 months, & 9 months|Children with fetal alcohol spectrum disorders receiving either choline or placebo for 9 months||participants|||Number
820977|NCT01149616|Secondary|Postop Nausea|NRS scale 0-10 for nausea. Zero indicates no nausea, Ten indicates the worst nausea imagined.|24 hours|||units on a scale||Inter-Quartile Range|Mean
820978|NCT01149616|Secondary|Amount of Postop Narcotic Usage|Patients were requested to record the number of prescribed oral analgesic (oxycodone 5 mg/aceteminophen 325 mg) tablets taken for the first 24 hours following discharge|24 hours|||number of tablets||Inter-Quartile Range|Median
820979|NCT01149616|Primary|Post Operative VAS Pain Scale|Patients were instructed to select a number between zero and ten to indicate the degree of pain they experience (zero being no pain and ten being the worst pain they could imagine). Therefore, ten is worse than zero.|24 hours|||units on a scale||Standard Deviation|Mean
820980|NCT01149655|Other Pre-specified|Mean Change From Baseline to Endpoint in Children's Global Assessment Scale (CGAS).|The CGAS was developed by Schaffer and colleagues to provide a global measure of severity of disturbance in children and adolescents. The CGAS is a rating scale for evaluating the overall functioning of a participant during a specified time period on a continuum from psychological or psychiatric sickness to health. The CGAS is a valid and reliable tool for rating a child's general level of functioning on a health-illness continuum. CGAS score (range 1-100) was a single item score for rating a child's general level of functioning on a health-illness continuum, with higher scores represented better functioning.|Baseline to Week 52/End of Phase 3 visit.|The ITT data set comprised of participants randomized to period 3. LOCF method was used to impute missing data. Week 1 participants analyzed were 95 and 45.||Units on a scale||Standard Deviation|Mean
820981|NCT01149655|Other Pre-specified|Mean Change From Baseline to Endpoint in PANSS Negative Subscale.|The PANSS consisted of 3 subscales were a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicated (absence of symptoms) and a score of 7 indicated (extremely severe symptoms). The 7 negative symptom constructs were blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation and stereotyped thinking. The PANSS Total Score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline to Week 52/End of Phase 3 visit.|The ITT data set comprised of participants randomized to period 3. LOCF method was used to impute missing data. Week 1 participants analyzed were 94 and 45.||Units on a scale||Standard Deviation|Mean
820982|NCT01149655|Other Pre-specified|Mean Change From Baseline to Endpoint in PANSS Positive Subscale.|The PANSS consisted of 3 subscales were a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicated (absence of symptoms) and a score of 7 indicated (extremely severe symptoms). The 7 positive symptom constructs were delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS Total Score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline to Week 52/End of Phase 3 visit.|The ITT data set comprised of participants randomized to period 3. LOCF method was used to impute missing data. Week 1 participants analyzed were 94 and 45.||Units on a scale||Standard Deviation|Mean
820983|NCT01149655|Other Pre-specified|Mean CGI-I Score at Endpoint.|Baseline for the double-blind maintenance phase was defined as the last visit with available data in the stabilization phase, and the CGI-I scale was completed prior to or on the first dose date in the double-blind maintenance phase. Response choices included: 0 = not assessed; 1 = very much improved,;2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; and 7 = very much worse.|Baseline to Week 52/End of Phase 3 visit.|The ITT data set comprised of participants randomized to period 3. LOCF method was used to impute missing data. Week 1 participants analyzed were 94 and 45 and Week 2 to Week 52 participants analyzed were 97 and 48.||Units on a scale||Standard Deviation|Mean
820984|NCT01149655|Other Pre-specified|Mean Change From Baseline to Endpoint in CGI-S Score.|"The severity of illness for each participant was rated using the CGI-S scale. To assess CGI-s, the Investigator answered the following question: Considering your total clinical experience with this particular population, how mentally ill is the participant at this time? Response choices included: 0= not assessed; 1= normal, not at all ill; 2= borderline mentally ill; 3= mildly ill; 4= moderately ill; 5= markedly ill; 6= severely ill; and 7= among the most extremely ill participants."|Baseline to Week 52/End of Phase 3 visit.|The ITT data set comprised of participants randomized to period 3. LOCF method was used to impute missing data. Week 1 participants analyzed were 94 and 45 and Week 2 to Week 52 participants analyzed were 97 and 48.||Units on a scale||Standard Deviation|Mean
820985|NCT01149655|Other Pre-specified|Mean Change From Baseline to Endpoint in PANSS Total Score.|The PANSS consisted of 3 subscales with a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicates (absence of symptoms) and a score of 7 indicates (extremely severe symptoms). The symptom constructs for each subscale were positive subscale, negative subscale and general psychopathology subscale. The PANSS Total Score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline to Week 52/End of Phase 3 visit.|The ITT data set comprised of participants randomized to period 3. LOCF (last observation carried forward) method was used to impute missing data. Week 1 had only 95 and 45 participants analyzed.||Units on a scale||Standard Deviation|Mean
820986|NCT01149655|Secondary|Percentage of Participants Who Discontinued Due to All Reasons Other Than Sponsor Discontinued Study.|Percentage of participants discontinued due to all reasons other than sponsor discontinued study were noted.|Baseline to Week 52/End of Phase 3 visit|The ITT data set comprised of all participants who were randomized to period 3.||percentage of participants|||Number
820987|NCT01149655|Secondary|Percentage of Participants Who Had Achieved Remission.|Percentage of participants who had achieved remission, where remission was defined as a score of ≤ 3 on each of the following specific PANSS items, maintained for a period of 6 months: delusions, unusual thought content, hallucinatory behavior, conceptual disorganization, mannerisms/ posturing, blunted affect, social withdrawal, and lack of spontaneity.|Baseline to Week 52/End of Phase 3 visit.|The ITT data set comprised of participants who were randomized to the double-blind treatment. For evaluation of remission, 48 of 98 aripiprazole participants and 19 of 48 placebo participants met the 6 month threshold for remission analysis. Of those, 21 of 48 aripiprazole participants and 8 of 19 placebo participants met criteria for remission.||percentage of participants|||Number
820988|NCT01149655|Secondary|Percentage of Responders in Each Treatment Group.|Percentage of responders in each treatment group (i.e, response defined as meeting stability criteria). Participants stabilized on aripiprazole (trial drug) within the approved dose range of 10 to 30 mg/day and are tolerable based on clinical judgment.|Baseline to Week 52/End of Phase 3 visit|The ITT data set comprised of all participants were randomized to period 3.||percentage of participants|||Number
820989|NCT01149655|Secondary|Percentage of Participants Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria.|Impending relapse was defined as meeting any of the following 5 criteria: 1) CGI-I score of ≥ 5 (minimally worse) and increase in individual PANSS items to a score > 4 with an absolute increase of ≥ 2 on that specific item or absolute increase of ≥ 4 on the combined 4 PANSS items. OR 2) CGI-I score of 6 or 7 (much or very much worse) OR 3) Hospitalization due to worsening of illness OR 4) Any suicidal behavior or answers of “yes” to Questions 4 or 5 on the suicidal ideation section of the C-SSRS OR 5) Violent or aggressive behavior resulting in clinically significant injury.|Baseline to Week 52/End of Phase 3 visit.|The ITT data set comprised of all participants who were randomized to period 3.||percentage of participants|||Number
820990|NCT01149655|Primary|Overall Relapse Rate (in Percent) From Randomization to Exacerbation of Psychotic Symptoms/Impending Relapse.|The primary efficacy variable was overall relapse rate from randomization, as assessed by Clinical Global Impression of Improvement (CGI-I) score ≥5, Positive and Negative Syndrome Scale (PANSS) scores for hostility or uncooperativeness ≥5, or ≥20% increase in PANSS Total Score. Impending relapse was defined as meeting any of the following 5 criteria: 1) CGI-I score of ≥ 5 (minimally worse) and increase in individual PANSS items to a score > 4 with an absolute increase of ≥ 2 on that specific item or absolute increase of ≥ 4 on the combined 4 PANSS items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content). OR 2) CGI-I score of 6 or 7 (much or very much worse) OR 3) Hospitalization due to worsening of illness OR 4) Any suicidal behavior or answers of “yes” to Questions 4 or 5 on the suicidal ideation section of the C-SSRS OR 5) Violent or aggressive behavior resulting in clinically significant injury.|Baseline to Week 52/End of Phase 3 visit.|For the primary analysis, participants that belonged to the ITT (intent to treat) data set were included in the analysis. Participants who were lost to follow-up or who were still in the study at the end of Week 52 were considered as censored on their date of last efficacy evaluation. The ITT data set comprised participants randomized to period 3.||relapse rate(percentage of participants)|||Number
820991|NCT01149733|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf|Blood samples drawn over 60 hour period|||ng*h/mL||Standard Deviation|Mean
820992|NCT01149733|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t|Blood samples drawn over 60 hour period|||ng*h/mL||Standard Deviation|Mean
820993|NCT01149733|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Cmax|Blood samples drawn over 60 hour period|||ng/mL||Standard Deviation|Mean
820994|NCT01149759|Secondary|Change in Epidermal Thickness|Change in lesional skin epidermal thickness at week 12 compared to baseline|12 weeks|9 participants were included in this analysis from Rockefeller University, this is a change in the skin thickness at week 12 compared to baseline||micrometer||Standard Deviation|Mean
820995|NCT01149759|Primary|SCORAD Change Score|"SCORAD (SCORing Atopic Dermatitis) is a clinical tool for assessing the severity (i.e., extent, intensity) of atopic dermatitis (AD) as objectively as possible with scores ranging from 0-100. The higher the score indicates more severe AD. For this outcome the SCORAD change score is computed as an absolute number which is comparing improvement in the SCORAD score of participants at week 12 compared to their SCORAD score at baseline."|12 weeks|9 were included in this analysis from Rockefeller University||Change Score||Standard Deviation|Mean
820996|NCT01149772|Primary|Kansas City Cardiomyopathy Questionnaire (KCCQ)|The KCCQ measures the health status of patients with congestive heart failure. The overall score is a mean score scaled from 0 - 100; where 0 represents most severe/limited functioning.|4 month (post treatment), 8 month follow/up, and 12 month follow/up|Only patients randomized for heart failure was required to complete the assessment. There were fewer patients randomized for congestive heart failure (CHF) as compared to COPD.||units on a scale||Standard Deviation|Mean
820997|NCT01149772|Primary|Chronic Respiratory Questionnaire_Dyspnea|The Chronic Respiratory Questionnaire (CRQ) measures the quality of life of patients with a chronic respiratory disease. The subscale Dyspnea looks at how much shortness of breath a patient experiences. The CRQ is a mean score and ranges from 1 - 7, where a higher score = better health.|4 month (post treatment), 8 month follow/up, 12 month follow/up|Only patients experiencing chronic lung problems (Chronic Obstructive Pulmonary Disease, emphysema, bronchitis, asthma) completed this assessment.||units on a scale||Standard Deviation|Mean
820998|NCT01149772|Primary|Chronic Respiratory Questionnaire_Mastery|The Chronic Respiratory Questionnaire (CRQ) measures the quality of life of patients with a chronic respiratory disease. The subscale Mastery looks at the patient's perceived control over the condition. The CRQ is a mean score and ranges from 1 - 7, where a higher score = better health|4 month (post treatment), 8 month follow/up, 12 month follow/up|Only patients experiencing chronic lung problems (COPD, emphysema, bronchitis, asthma) completed this assessment.||units on a scale||Standard Deviation|Mean
820999|NCT01149772|Primary|Chronic Respiratory Questionnaire_Fatigue|The Chronic Respiratory Questionnaire (CRQ) measures the quality of life of patients with a chronic respiratory disease. This subscale measures the amount of fatigue patients experience with the condition. The CRQ is a mean score and ranges from 1 - 7, where a higher score = better health.|4 month (post treatment), 8 month follow/up, 12 month follow/up|Only patients experiencing chronic lung problems (COPD, emphysema, bronchitis, asthma) completed this assessment.||units on a scale||Standard Deviation|Mean
821000|NCT01149772|Primary|Beck Anxiety Inventory (BAI)|The BAI measures an individual's level of anxiety. The measure is summed and ranges from 0 - 63 (individual item score range 0 -3 per 21 items); were higher scores = worse symptoms.|4 month (post treatment), 8 month follow/up, and 12 month follow/up|||units on a scale||Standard Deviation|Mean
821001|NCT01149772|Primary|Patient Health Questionnaire -9 (PHQ-9)|The PHQ-9 measures an individual's level of depression. The measure is summed and ranges from 0 - 27 (individual item score range 0 - 3 per 9 items); where higher scores = worse symptoms.|4 month (post treatment), 8 month follow/up, and 12 month follow/up|||units on a scale||Standard Deviation|Mean
821002|NCT01149785|Secondary|Metabolite to Parent Ratio of Maximum Observed Plasma Concentration (MRCmax)|Metabolite to parent molar ratio of maximum observed plasma concentration (Cmax).|0 (Pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and day 0, 0 (pre-dose), 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, 192 and 312 hrs post crizotinib dose in period 2|The PK parameter analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||Ratio||Standard Deviation|Geometric Mean
821003|NCT01149785|Secondary|Metabolite to Parent Ratio of Area Under the Curve From Time Zero to Extrapolated Infinite Time [MRAUC(0-∞)]|Molar ratio of metabolite to parent area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞) [MRAUC(0-∞)].|0 (Pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and day 0, 0 (pre-dose), 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, 192 and 312 hrs post crizotinib dose in period 2|The PK parameter analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||Ratio||Standard Deviation|Geometric Mean
821004|NCT01149785|Secondary|Metabolite to Parent Ratio of Area Under the Curve From Time Zero to Last Quantifiable Concentration for Crizotinib Metabolite Ratio (MRAUClast)|Molar ratio of metabolite to parent area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (MRAUClast).|0 (Pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and day 0, 0 (pre-dose), 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, 192 and 312 hrs post crizotinib dose in period 2|The PK parameter analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||Ratio||Standard Deviation|Geometric Mean
821005|NCT01149785|Secondary|Maximum Observed Plasma Concentration (Cmax) for Crizotinib Metabolite (PF-06260182)||0 (Pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and day 0, 0 (pre-dose), 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, 192 and 312 hrs post crizotinib dose in period 2|The PK parameter analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng/mL||Standard Deviation|Geometric Mean
821006|NCT01149785|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) for Crizotinib Metabolite (PF-06260182)||0 (Pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and day 0, 0 (pre-dose), 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, 192 and 312 hrs post crizotinib dose in period 2|The PK parameter analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||hr||Full Range|Median
821007|NCT01149785|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] for Crizotinib Metabolite (PF-06260182)|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞) of crizotinib metabolite (PF-06260182).|0 (Pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and day 0, 0 (pre-dose), 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, 192 and 312 hrs post crizotinib dose in period 2|The PK parameter analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng*hr/mL||Standard Deviation|Geometric Mean
821008|NCT01149785|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Crizotinib Metabolite (PF-06260182)|Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast) of crizotinib metabolite (PF-06260182).|0 (Pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and day 0, 0 (pre-dose), 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, 192 and 312 hrs post crizotinib dose in period 2|The PK parameter analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng*hr/mL||Standard Deviation|Geometric Mean
821009|NCT01149785|Secondary|Apparent Volume of Distribution (Vz/F)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|0 (Pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and day 0, 0 (pre-dose), 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, 192 and 312 hrs post crizotinib dose in period 2|The PK parameter analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||L||Standard Deviation|Geometric Mean
821010|NCT01149785|Secondary|Apparent Oral Clearance (CL/F)|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.|0 (Pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and day 0, 0 (pre-dose), 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, 192 and 312 hrs post crizotinib dose in period 2|The PK parameter analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||L/hr||Standard Deviation|Geometric Mean
821011|NCT01149785|Primary|Maximum Observed Plasma Concentration (Cmax)||0 (Pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and day 0, 0 (pre-dose), 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, 192 and 312 hrs post crizotinib dose in period 2|The PK parameter analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng/mL||Standard Deviation|Geometric Mean
821012|NCT01149785|Secondary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (Pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and day 0, 0 (pre-dose), 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, 192 and 312 hrs post crizotinib dose in period 2|The PK parameter analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||hr||Standard Deviation|Mean
821013|NCT01149785|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 (Pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and day 0, 0 (pre-dose), 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, 192 and 312 hrs post crizotinib dose in period 2|The PK parameter analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||hr||Full Range|Median
821014|NCT01149785|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast).|0 (Pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and day 0, 0 (pre-dose), 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, 192 and 312 hrs post crizotinib dose in period 2|The PK parameter analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng*hr/mL||Standard Deviation|Geometric Mean
821015|NCT01149785|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|0 (Pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hours (hrs) post crizotinib dose in period 1 and day 0, 0 (pre-dose), 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, 192 and 312 hrs post crizotinib dose in period 2|The pharmacokinetic (PK) parameter analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng*hr/mL||Standard Deviation|Geometric Mean
821016|NCT01149863|Secondary|Number of Patients Who on Day 1 Collected > 10 x 10^6 CD34+ Cells/kg Following Plerixafor Dosing at 1500 Hrs||Within the first 5 days following plerixafor initiation|||Participants|||Number
821017|NCT01149863|Primary|Number of Patients Who Collected ≥ 6 x 10^6 CD34+ Cells by Day 5 (4 Apheresis Sessions) With Plerixafor Administration at 1500.||Within the first 5 days following plerixafor initiation|||Participants|||Number
821018|NCT01149876|Secondary|Change in Rhytides|"Secondary outcome measures will be change in rhytides of baseline compared to week 16.
Rhytides will be assessed clinically using a 0-6 scale where 0 is no lines and 6 is very deep lines."|baseline to week 16|||units on a scale||Standard Deviation|Mean
821019|NCT01149876|Primary|Change in Hyperpigmentation of the Face|"Primary outcome measure will be change in hyperpigmentation of baseline compared to week 16.
Hyperpigmentation will be measured clinically using a 0-6 scale where 0 is no hyperpigmentation and 6 is very severe hyperpigmentation."|baseline to 16 weeks|||units on a scale||Standard Deviation|Mean
821020|NCT01150097|Primary|Change in Renal Function|Change in renal function was assessed by the estimated Glomerular Filtration Rate (eGFR) using the abbreviated (4 variables) Modification of Diet in Renal Disease (MDRD-4) formula which was developed by the MDRD Study Group and has been validated in patients with chronic kidney disease. The MDRD-4 formula used for the eGFR calculation is: eGFR (mL/min/1.73m^2) = 186.3*(C^-1.154)*(A^-0.203)*G*R, where C is the serum concentration of creatinine (mg/dL), A is age (years), G=0.742 when gender is female, otherwise G=1, R=1.21 when race is black, otherwise R=1.|from months 24 to 36|The analysis population included extension participants who had both post-extension baseline and month 36 values only.||mL/min/1.73m^2||Standard Deviation|Mean
821021|NCT01150097|Secondary|Incidence Rate of tBPAR|The number of participants who had a tBPAR was analyzed. tBPAR was defined as a BPAR which was treated with anti-rejection therapy. The RAI is used to score liver biopsies with acute rejection and is composed of 3 categories (portal inflammation, bile duct inflammation damage, and venous endothelial inflammation) each scored on a scale of 0 (absent) to 3 (severe) by a trained pathologist. The total RAI score = the sum of the scores of the 3 categories and ranges from 0 to 9, with a higher score indicating greater rejection.|from months 24 - 36|All extension participants||Participants|||Number
821022|NCT01150097|Primary|Incidence Rate of Composite Efficacy Failure Defined as Graft Loss or Death|The number of participants who experienced graft loss or death was analyzed. The graft was presumed to be lost on the day the patient was newly listed for a liver graft, received a graft re-transplant, or died.|from months 36 - 48|Participants from the everolimus + reduced tacrolimus group and the tacrolimus elimination group||Participants|||Number
821023|NCT01150097|Primary|Incidence Rate of Composite Efficacy Failure Defined as Graft Loss or Death|The number of participants who experienced graft loss or death was analyzed. The graft was presumed to be lost on the day the patient was newly listed for a liver graft, received a graft re-transplant, or died.|from months 24 to 36|All extension participants||Participants|||Number
821024|NCT01150097|Primary|Incidence Rate of Composite Efficacy Failure Defined as Treated Biopsy Proven Acute Rejection (tBPAR ), Graft Loss or Death|The number of participants who experienced composite efficacy failure was analyzed. Composite efficacy failure was defined as treated biopsy proven acute rejection (tBPAR), graft loss, or death. A BPAR was defined as an acute rejection confirmed by biopsy with a Rejection Activity Index (RAI) score ≥ 3. tBPAR was defined as a BPAR which was treated with anti-rejection therapy. The RAI is used to score liver biopsies with acute rejection and is composed of 3 categories (portal inflammation, bile duct inflammation damage, and venous endothelial inflammation) each scored on a scale of 0 (absent) to 3 (severe) by a trained pathologist. The total RAI score = the sum of the scores of the 3 categories and ranges from 0 to 9, with a higher score indicating greater rejection. The graft was presumed to be lost on the day the patient was newly listed for a liver graft, received a graft re-transplant, or died.|from months 36 to 48|Participants from the everolimus + reduced tacrolimus group and the tacrolimus elimination group||Participants|||Number
821025|NCT01150097|Primary|Incidence Rate of Composite Efficacy Failure Defined as Treated Biopsy Proven Acute Rejection (tBPAR ), Graft Loss or Death|The number of participants who experienced composite efficacy failure was analyzed. Composite efficacy failure was defined as treated biopsy proven acute rejection (tBPAR), graft loss, or death. A BPAR was defined as an acute rejection confirmed by biopsy with a Rejection Activity Index (RAI) score ≥ 3. tBPAR was defined as a BPAR which was treated with anti-rejection therapy. The RAI is used to score liver biopsies with acute rejection and is composed of 3 categories (portal inflammation, bile duct inflammation damage, and venous endothelial inflammation) each scored on a scale of 0 (absent) to 3 (severe) by a trained pathologist. The total RAI score = the sum of the scores of the 3 categories and ranges from 0 to 9, with a higher score indicating greater rejection. The graft was presumed to be lost on the day the patient was newly listed for a liver graft, received a graft re-transplant, or died.|from months 24 to 36|All extension participants||Participants|||Number
821026|NCT01150123|Secondary|Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 2|GMR was calculated at Day 721 relative to baseline (Day 1) of serotype-specific (Ia, Ib, III) GBS IgG antibody levels across cohorts 3 and 4.|Day 1 and Day 721|Analysis was done on secondary persistence PPS.||Ratios||95% Confidence Interval|Geometric Mean
821027|NCT01150123|Secondary|Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 1|GMR was calculated at Day 721 relative to baseline (Day 1) of serotype-specific (Ia, Ib, III) GBS IgG antibody levels across all cohorts 1 and 2.|Day 1 and Day 721|Analysis was done on secondary persistence PPS||Ratios||95% Confidence Interval|Geometric Mean
821028|NCT01150123|Secondary|Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2|The persistence of Serotype-specific (Ia, Ib & III) GBS IgG antibody response assessed by comparing ELISA responses in terms of GMCs at day 721 after the first injection for subjects enrolled in cohort 3 and 4.|Day 1 and Day 721|Analysis was done on secondary persistence PPS.||µg/mL||95% Confidence Interval|Geometric Mean
821029|NCT01150123|Secondary|Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1|The persistence of Serotype–specific (Ia, Ib & III) GBS IgG antibody response was assessed by comparing ELISA responses in terms of GMCs at day 721 after the first injection for subjects enrolled in cohorts 1 and 2.|Day 1 and Day 721|Analysis was done on secondary persistence PPS - All the subjects who provided all serum sample results from Baseline (prior to vaccination) through Day 721 within protocol required windows.||µg/mL||95% Confidence Interval|Geometric Mean
821030|NCT01150123|Secondary|Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 2|Safety was assessed in terms of number of participants with unsolicited AEs after receiving GBS trivalent vaccine, reported from day 1 to day 721 across subjects in cohorts 3 and 4.|Day 1 through Day 721|Analysis was done on Unsolicited Safety Set.||participants|||Number
821031|NCT01150123|Secondary|Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 1|Safety was assessed in terms of number of participants with unsolicited AEs after receiving GBS trivalent vaccine, reported from day 1 to day 721 across subjects in cohorts 1 and 2.|Day 1 through Day 721|Analysis was done on unsolicited safety set - All subjects in the Exposed Set who provided information about postvaccination unsolicited AEs.||participants|||Number
821032|NCT01150123|Secondary|Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2|Safety was assessed in terms of number of participants reporting solicited local and systemic adverse events after receiving GBS vaccine from day 1 to day 7 for subjects in cohorts 3 and 4.|Day 1 to Day 7|Analysis was done on Solicited Safety Set||participants|||Number
821033|NCT01150123|Primary|Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361|GMRs relative to baseline (Day 1) of serotype-specific (Ia, Ib, III) GBS IgG antibody levels in healthy subjects for potential use in non-pregnant women, measured at Day 361 across all cohorts.|Day 1 and day 361|Analysis was done on Co-Primary PPS.||Ratios||95% Confidence Interval|Geometric Mean
821034|NCT01150123|Primary|Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361|Serotype-specific (Ia, Ib & III) GBS IgG antibody levels in healthy subjects for potential use in non-pregnant woman was assessed in terms of GMCs at Day 361 across all cohorts.|Day 1 and Day 361|Analysis was done on Co-Primary PPS||µg/mL||95% Confidence Interval|Geometric Mean
821035|NCT01150123|Primary|Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2|The percentage of subjects achieving a specific threshold of antibody concentrations of ≥ 0.5 µg/mL at day 361 across all the cohorts for potential use in non-pregnant women.|Day 1 and Day 361|Analysis was done on Co-primary PPS - The subjects who received the vaccine correctly; provided evaluable serum samples at baseline and Day 361; and had no major protocol violations as defined prior to analysis||percentage of subjects|||Number
821036|NCT01150123|Primary|Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype|Geometric mean ratios (GMRs) relative to baseline (Day 1) of serotype-specific (Ia, Ib, III) GBS IgG antibody levels measured at Day 61 for subjects across cohorts 1 and 2.|Day 61/Day 1|Analysis was done on Primary PPS.||Ratios||95% Confidence Interval|Geometric Mean
821037|NCT01150123|Secondary|Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1|Safety was assessed in terms of number of participants reporting solicited local and systemic adverse events after receiving trivalent GBS vaccine from day 1 to day 7 for subjects across cohorts 1 and 2.|Day 1 to Day 7|Analysis was done on Solicited Safety Set - All subjects in the Exposed Set who provided data on post vaccination local or systemic AEs or other signs of reactogenicity.||participants|||Number
821038|NCT01150123|Primary|Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61|Serotype–specific (Ia, Ib & III) group B streptococcus (GBS) IgG antibody levels in healthy subjects for potential use in pregnant woman was assessed in terms of Geometric Mean Concentrations (GMCs) at Day 61 in cohorts 1 and 2.|Day 1 and Day 61|Analysis was done on Primary PPS||µg/mL||95% Confidence Interval|Geometric Mean
821039|NCT01150123|Primary|Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1|The percentage of subjects achieving a specific threshold of antibody concentrations of ≥ 0.5 µg/mL as determined by ELISA at day 61 across cohorts 1 and 2 for potential use in pregnant women.|Day 1 and Day 61|Analysis was done on primary Per Protocol Set (PPS) - The subjects who received the vaccine correctly; provided evaluable serum samples at baseline and Day 61; and had no major protocol violations as defined prior to analysis.||percentage of subjects|||Number
821040|NCT01150357|Secondary|Change From Baseline in Mean Ambulatory Blood Pressure (MABP) in Non-­Dipper Participants at Endpoint (Phase 1)|ABPM was performed over a 24­hour period using an automatic ABPM device to record the blood pressure as per study defined criteria. Non­dippers were defined as those participants in whom there was a decrease in mean night time ABPM less than 10% as compared to average daytime ABPM.|Baseline to endpoint (Week 4 or LOCF)|"Analysis was performed in subset of FAS participants from selected centers who consented to undergo ABPM at baseline and at Week 4 or LOCF. Here, Number of participants analyzed signifies participants evaluable for this outcome measure at Week 4 or LOCF for each arm, respectively."||mmHg||Standard Deviation|Mean
821041|NCT01150357|Secondary|Change From Baseline in Mean Ambulatory Blood Pressure (MABP) in Dipper Participants at Endpoint (Phase 1)|ABPM was performed over a 24­hour period using an automatic ABPM device to record the blood pressure as per study defined criteria. Dippers were defined as those participants in whom there was a decrease in mean night time (6pm – 6am) ABPM more than or equal to (≥ ) 10% as compared to average daytime (6am –6pm) ABPM.|Baseline to endpoint (Week 4 or LOCF)|"Analysis was performed in subset of FAS participants from selected centers who consented to undergo ABPM at baseline and at Week 4 or LOCF. Here, Number of participants analyzed signifies participants evaluable for this outcome measure at Week 4 or LOCF for each arm, respectively."||mmHg||Standard Deviation|Mean
821042|NCT01150357|Secondary|Change From Baseline in Mean Ambulatory Systolic Blood Pressure (MASBP) During Day and Night at Week 4 (Phase 1)|ABPM was performed over a 24­hour period using an automatic ABPM device to record the blood pressure as per study defined criteria. Day time was defined as the average of the hourly means between 6 am and 10 pm while the night time mean was the average of the hourly means between 10 pm and 6 am.|Baseline to Week 4|Analysis was performed in subset of FAS participants from selected centers who consented to undergo ABPM at baseline and at Week 4. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||mmHg||Standard Error|Least Squares Mean
821043|NCT01150357|Secondary|Change From Baseline in Mean Ambulatory Systolic and Diastolic Blood Pressure (MASBP and MADBP) at Endpoint (Phase 1)|Ambulatory Blood Pressure Monitoring (ABPM) was performed over a 24­hour period using an automatic ABPM device to record the blood pressure as per study defined criteria. The participants who were selected for this evaluation wore the ABPM device for 24 hours, returned to the clinic upon completion of the 24­hour monitoring period for removal of device and BP assessments. The ABPM device was pre­set to collect readings every 20 minutes. Mean hourly systolic and diastolic blood pressure were calculated for each participant at post dosing 1 – 24 hours.|Baseline to endpoint (Week 4 or LOCF)|Analysis was performed in subset of FAS participants from selected centers who consented to undergo ABPM at baseline and at Week 4 or LOCF. Here 'Number of participants analyzed' signifies those participants evaluable for this measure at specified time points for each arm, respectively.||mmHg||Standard Deviation|Mean
821044|NCT01150357|Secondary|Percentage of Participants Achieving a Positive Treatment Response at Endpoint (Phase 1)|Treatment responders were defined as participants with msSBP less than 95th percentile (for age, gender and height) or a 7 mmHg decrease in msSBP from the baseline.|Baseline to endpoint (Week 4 or LOCF)|"The analysis was performed on the FAS population. Here, Number of participants analyzed signifies participants evaluable for this outcome measure at Week 4 or LOCF for each arm, respectively."||Percentage of participants|||Number
821045|NCT01150357|Secondary|Change in Mean Arterial Pressure (MAP) From Week 4 to Endpoint (Phase 2)|MAP was defined as the average arterial pressure during a single cardiac cycle. The MAP was measured as sum of DBP and one third of difference between SBP and DBP i.e. MAP = DBP+1/3*(SBP-DBP).|Week 4 to endpoint (Week 8 or LOCF)|The analysis was performed on the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||mmHg||Standard Error|Mean
821046|NCT01150357|Secondary|Change From Baseline in Mean Arterial Pressure (MAP) at Endpoint (Phase 1)|MAP was defined as the average arterial pressure during a single cardiac cycle. The MAP was measured as sum of diastolic blood pressure (DBP) and one third of difference between systolic blood pressure (SBP) and DBP i.e. MAP = DBP+1/3*(SBP­DBP).|Baseline to endpoint (Week 4 or LOCF)|"The analysis was performed on the FAS population. Here, Number of participants analyzed signifies participants evaluable for MAP at Week 4 (or LOCF) for each arm, respectively."||mmHg||Standard Error|Mean
821047|NCT01150357|Secondary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Week 4 to Endpoint (Phase 2)|Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 1­2 minute intervals and the mean of three sDBP measurements were used as the average sitting office blood pressure for that visit.|Week 4 to endpoint (Week 8 or LOCF)|"The analysis was performed on the FAS population. Here, Number of participants analyzed signifies participants evaluable for msDBP at Week 8 or LOCF for each arm, respectively."||mmHg||Standard Error|Mean
821048|NCT01150357|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Endpoint (Phase 1)|Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 1­2 minute intervals and the mean of three sDBP measurements were used as the average sitting office blood pressure for that visit.|Baseline to endpoint (Week 4 or LOCF)|"The analysis was performed on the FAS population. Here, Number of participants analyzed signifies participants evaluable for msDBP at Week 4 or LOCF for each arm, respectively."||mmHg||Standard Error|Mean
821049|NCT01150357|Secondary|Number of Participants With Adverse Events and Serious Adverse Events From Week 4 to Week 8 (Phase 2)|AEs were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. SAEs were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards.|From Week 4 to Week 8|The analysis was performed on the SAF which included all participants who received at least one dose of study treatment during phase 2 (week 4 to week 8).||participants|||Number
821050|NCT01150357|Secondary|Number of Participants With Adverse Events and Serious Adverse Events From Baseline to Week 4 (Phase 1)|Adverse events (AEs) were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events (SAEs) were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards.|Baseline up to Week 4|The analysis was performed on the Safety Sets (SAF), SAF is all participants who received at least one dose of study treatment during phase 1 (baseline to week 4)||participants|||Number
821051|NCT01150357|Primary|Change in Mean Sitting Systolic Blood Pressure (msSBP) From Week 4 to Endpoint (Phase 2)|Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 1­2 minute intervals and the mean of three sSBP measurements were used as the average sitting office blood pressure for that visit.|Week 4 to endpoint (Week 8 or LOCF)|The primary analysis was performed on the FAS population.||mmHg||Standard Error|Mean
821052|NCT01150357|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Endpoint (Phase 1)|Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 1­2 minute intervals and the mean of three sSBP measurements were used as the average sitting office blood pressure for that visit.|Baseline to endpoint (Week 4 or Last observation carried forward (LOCF))|"The primary analysis was performed on the Full Analysis Set (FAS), defined as all participants who received at least one dose of study treatment and had at least one post­baseline assessment for primary efficacy. Here, Number of participants analyzed signifies participants evaluable for msSBP at Week 4 or LOCF for each arm, respectively."||millimeter(s) of mercury (mmHg)||Standard Error|Mean
821053|NCT01150409|Primary|Incidence of Hypotension Between Study Days 8 and 14 (Within 7 Days of the Initiation of Study Drug).|Study screening/enrollment stopped due to lack of eligible subjects. No outcome measures were analyzed due to the low enrollment.|Day 14||||||
821054|NCT01150461|Secondary|Percentage Change From Baseline in Left Ventricular Mass at 1 Year as Assessed by Magnetic Resonance Imaging.||Baseline and 1 year|||Percentage change in LV mass||Inter-Quartile Range|Mean
821055|NCT01150461|Primary|Percentage Change From Baseline in Extent of Left Ventricular Fibrosis at 1 Year as Assessed by Magnetic Resonance Imaging.||Baseline and 1 year|||Percentage change in fibrotic myocardium||Standard Deviation|Mean
821056|NCT01150474|Secondary|Satisfaction With Pain Relief|"Patient satisfaction with pain relief was evaluated 24 hours after surgery using a linear analog satisfaction scale, with 0 being very dissatisfied, and 10 being very satisfied."|Approximately 24 hours following surgery|||units on a scale||Standard Deviation|Mean
821057|NCT01150474|Secondary|Number of Subjects Who Used Antiemetic Rescue Medications||First 24 hours after surgery|||participants|||Number
821058|NCT01150474|Secondary|Number of Times Antiemetic Rescue Medication Was Used||First 24 hours after surgery|||number of times antiemetics used||Standard Deviation|Mean
821059|NCT01150474|Secondary|Number of Subjects With Vomiting|This information was taken from the medical record.|Within 20 hours of surgery|||participants|||Number
821060|NCT01150474|Secondary|Number of Subjects With Nausea|This information was taken from the medical record.|Approximately 12 hours after surgery|||participants|||Number
821061|NCT01150474|Secondary|Narcotic Rescue Medication|Use of all ancillary narcotic medications was taken from the medical record.|For 24 hours following surgery|||mg IV morphine equivalents||Standard Deviation|Mean
821062|NCT01150474|Secondary|Pain at Hour 20|"Pain at 20 hours was recorded using a linear analog pain scale, with 0 being no pain, and 10 being worst pain imaginable."|20 hours after surgery.|||units on a scale||Standard Deviation|Mean
821063|NCT01150474|Secondary|Pain at Hour 12|"Pain at 12 hours was recorded using a linear analog pain scale, with 0 being no pain, and 10 being worst pain imaginable."|12 hours after surgery.|||units on a scale||Standard Deviation|Mean
821064|NCT01150474|Primary|Pain at Hour 4|"Pain at 4 hours was recorded using a linear analog pain scale, with 0 being no pain, and 10 being worst pain imaginable."|4 hours following surgery|||units on a scale||Standard Deviation|Mean
821065|NCT01150500|Secondary|Clinical Endpoints|Success (device, lesion, procedure), major adverse cardiac events (MACE), target vessel failure (TVF), and stent thrombosis|5 Years||||||
821066|NCT01150500|Secondary|Percent Diameter Stenosis|The value calculated as 100 x (Reference Vessel Diameter(RVD) - Minimum luminal diameter(MLD))/ RVD using the mean values from orthogonal views (when possible) by quantitative coronary angiography(QCA).|Baseline and 9 month|67 lesions in 65 patients were analyzed.||% DS (diameter stenosis)||Standard Deviation|Mean
821067|NCT01150500|Secondary|Minimum Luminal Diameter|The average of two orthogonal views(when possible) of narrowest point within the area of assessment-in lesion, in stent or in segment. minimal luminal diameter is visually estimated during angiography by the investigator; it is measured during quantitative coronary angiography by the Angiographic Core Laboratory.|9 month|67 lesions in 65 patient were analyzed.||mm||Standard Deviation|Mean
821068|NCT01150500|Secondary|Binary Angiographic Restenosis|Defined as => 50% in-stent diameter stenosis at the follow-up angiogram at 9 month. If an in-stent measurement is not available, the in-lesion diameter was used.|Baseline and 9 month|67 lesions in 65 patients were analysed.||percentage of patient|||Number
821069|NCT01150500|Secondary|Late Lumen Loss|Defined as the difference between the post-procedure immediate minimal lumen diameter (MLD) and the follow-up angiography MLD at 9 month.|Baseline and 9 months|67 Lesions in 65 patients are analysed.||mm||Standard Deviation|Mean
821070|NCT01150500|Secondary|MACE (Major Adverse Cardiac Event)|Death, myocardial infarction (Q-wave and non-Q-wave), emergent coronary bypass, or clinically-driven repeat target lesion revascularization by percutaneous surgical methods.|Baseline and 9 month|65 patients were analyzed as ITT population||percentage of patient|||Number
821071|NCT01150500|Primary|Target Lesion Failure(TLF)|Target Lesion Failure (TLF) at 9 months post-procedure defined as a composite measure of cardiac death, heart attack attributed to the target vessel (target vessel myocardial infarction), and ischemia-driven target lesion revascularization (TLR)|9 month|All 65 patients enrolled were analyzed as intent-to-treat (ITT) population and per protocol(PP) population.||percentage of TLF|||Number
821072|NCT01150760|Primary|Intensive Care Unit Length of Stay||Participants were followed up until their hospital discharge after bowel resection|Intent-to-treat population (included patients who met all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during the patient's hospitalization)||Days||Standard Deviation|Mean
821073|NCT01150760|Primary|Percentage of Patients Discharged to Various Locations|Location of discharge for patients who were admitted to the hospital for their bowel resection from home|Hospital discharge after bowel resection|Intent-to-treat population (included patients who met all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during the patient's hospitalization)||Percent of participants|||Number
821074|NCT01150760|Primary|Percentage of Patients Who Were Readmitted Within 30 Days of Discharge||Between 0-30 days after hospital discharge after bowel resection|Intent-to-treat population (included patients who met all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during the patient's hospitalization)||Percent of participants|||Number
821075|NCT01150760|Primary|Percentage of Patients Who Were Readmitted Between 16 and 30 Days After Discharge||Between 16-30 days after hospital discharge after bowel resection|Intent-to-treat population (included patients who met all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during the patient's hospitalization)||Percent of participants|||Number
821076|NCT01150760|Primary|Percentage of Patients Who Were Readmitted Within 15 Days of Discharge||Within 15 days of discharge from hospitalization for bowel resection|Intent-to-treat population (included patients who met all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during the patient's hospitalization)||Percent of partcipants|||Number
821077|NCT01150760|Primary|Percentage of Patients With In-hospital Other Morbidity|Other morbidity was identified using ICD-9-CM diagnosis and procedure codes for disruption of wound, decubitus ulcer, or postoperative complications not elsewhere classified.|Participants were followed up until their hospital discharge after bowel resection|Intent-to-treat population (Included patients who meet all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during their hospitalization)||Percent of participants|||Number
821078|NCT01150760|Primary|Percentage of Patients With In-hospital Thromboembolic Morbidity|Thromboembolic morbidity was identified using ICD-9-CM diagnosis and procedure codes for pulmonary embolism and infarction; arterial embolism and thrombosis or thrombosis of the lower extremities; vascular disorders of the kidney; acute vascular insufficiency of the intestine; or venous thromboembolism.|Participants were followed up until their hospital discharge after bowel resection|Intent-to-treat population (Included patients who meet all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during their hospitalization)||Percent of participants|||Number
821079|NCT01150760|Primary|Percentage of Patients With In-hospital Infection Morbidity|Infection morbidity was identified using ICD-9-CM diagnosis and procedure codes for infection due to central venous catheter; abscess of intestine; peritoneal abscess; sepsis or severe sepsis; infection due to vascular device, implant and graft; urinary tract infection; disruption of internal or external surgical wound; persistent postoperative fistula; or postoperative infection.|Participants were followed up until their hospital discharge after bowel resection|Intent-to-treat population (Included patients who meet all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during their hospitalization)||Percent of participants|||Number
821080|NCT01150760|Secondary|Postoperative Length of Hospital Stay|Calendar day of discharge - calendar day of surgery = postoperative length of stay|Measured from the day after bowel resection to the day of hospital discharge|Modified intent-to-treat (included patients who met all base population, inclusion and exclusion criteria, received ≥ 3 and ≤ 15 doses of alvimopan [for alvimopan cohort] during the patient's hospitalization, and received parenteral opioid on ≥ 1 postoperative day)||Days||Standard Deviation|Mean
821081|NCT01150760|Primary|Percentage of Patients With In-hospital Pulmonary Morbidity|Pulmonary morbidity was identified using ICD-9-CM diagnosis and procedure codes for pneumonia; infectious pneumonia; respiratory complications, pulmonary collapse; acute respiratory failure or edema; pulmonary congestion and hypostasis; pulmonary/respiratory insufficiency after trauma and/or surgery; dyspnea; or respiratory arrest; transfusion related acute lung injury.|Participants were followed up until their hospital discharge after bowel resection|Intent-to-treat population (Included patients who meet all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during their hospitalization)||Percent of participants|||Number
821082|NCT01150760|Primary|Percentage of Patients With In-hospital Cerebrovascular Morbidity|Cerebrovascular morbidity was identified using ICD-9-CM diagnosis and procedure codes for ischemic, thrombotic, embolic or hemorrhagic cerebrovascular accidents; acute but ill-defined cerebrovascular disease; transient cerebral ischemia; syncope; or postoperative cerebrovascular accident.|Participants were followed up until their hospital discharge after bowel resection|Intent-to-treat population (Included patients who meet all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during their hospitalization)||Percent of participants|||Number
821083|NCT01150760|Primary|Percentage of Patients With In-hospital Cardiovascular Morbidity|Cardiovascular morbidity was identified using ICD-9-CM diagnosis and procedure codes for myocardial infarction; other ischemic events; congestive heart failure and shock; arrhythmias; or other cardiovascular events (cardiac complications, peripheral vascular complications).|Participants were followed up until their hospital discharge after bowel resection|Intent-to-treat population (Included patients who meet all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during their hospitalization)||Percent of participants|||Number
821084|NCT01150760|Primary|Percentage of Patients With Reported In-hospital Postoperative Gastrointestinal (GI) Morbidity|GI morbidity will be identified using International Classification of Disease 9th Edition Clinical Modification (ICD-9-CM) diagnosis and procedure codes for paralytic ileus, flatulence, eructation, gas pain, insertion of a nasogastric tube, total parenteral nutrition, peripheral parenteral nutrition, digestive symptom complications, diarrhea following GI surgery, intestinal obstruction, abdominal pain, peritoneal adhesions, unspecified protein-calorie malnutrition, parenteral infusion of concentrated nutritional substances, or enteral infusion of concentrated nutritional substances.|Participants were followed up until their hospital discharge after bowel resection|Intent-to-treat population (Included patients who meet all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during their hospitalization)||Percent of participants|||Number
821085|NCT01150760|Primary|Percentage of Patients Who Died|All-cause|Participants were followed up until their hospital discharge after bowel resection|Intent-to-treat population (Included patients who meet all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during their hospitalization)||Percent of participants|||Number
821086|NCT01150903|Secondary|Percentage of Participants With New Diagnosis of Underlying Condition at PDE5i Establishment During the End of Study Period|New diagnosis of underlying condition at PDE5i establishment was defined as any new diagnosis of interest between day 0 (index prescription) and day 91 in participants who received the index prescription between July 1, 2006 and June 30, 2008 for the two-years period combined. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders.|Up to 2 years (End of study period - July 2006 to June 2008)|Evaluable analysis population included all participants who received an index PDE5i prescription (sildenafil, tadalafil or vardenafil) during the study period (target population). Last observation carried forward method was used. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.||Percentage of participants|||Number
821087|NCT01150903|Secondary|Percentage of Participants With Underlying Condition at PDE5i Establishment During the End of Study Period|Underlying condition at PDE5i market introduction was defined as any diagnosis of interest until day -1 in participants who received the index prescription between July 1, 2006 and June 30, 2008 for the two years period combined. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders.|Up to 2 years (End of study period - July 2006 to June 2008)|Evaluable analysis population included all participants who received an index PDE5i prescription (sildenafil, tadalafil or vardenafil) during the study period (target population). Last observation carried forward method was used. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.||Percentage of participants|||Number
821088|NCT01150903|Secondary|Percentage of Participants With New Diagnosis of Underlying Condition at PDE5i Market Introduction During the Early Study Period|New diagnosis of underlying condition at PDE5i market introduction was defined as any new diagnosis of interest until day -1 in participants who received the index prescription between January 1, 1999 and December 31, 2001 for the three years period combined. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders.|Up to 3 years (Early study period - January 1999 to December 2001)|Evaluable analysis population included all participants who received an index PDE5i prescription (sildenafil, tadalafil or vardenafil) during the study period (target population). Last observation carried forward method was used. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.||Percentage of participants|||Number
821089|NCT01150903|Primary|Percentage of Participants With Underlying Condition at PDE5i Market Introduction During the Early Study Period|Underlying condition at PDE5i market introduction was defined as any diagnosis of interest until day -1 in participants who received the index prescription between January 1, 1999 and December 31, 2001 for the three years period combined. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders.|Up to 3 years (Early study period - January 1999 to December 2001)|Evaluable analysis population included all participants who received an index PDE5i prescription (sildenafil, tadalafil or vardenafil) during the study period (target population). Last observation carried forward method was used. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.||Percentage of participants|||Number
821090|NCT01150903|Primary|Percentage of Participants With New Diagnosis of Underlying Condition Between Day 366 and Day 457 Post the Index PDE5i Prescription|New diagnosis of underlying condition was defined as any new diagnosis of interest recorded in the relevant time period. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders.|Day 366 up to Day 457 post index prescription|Evaluable analysis population included all participants who received an index PDE5i prescription (sildenafil, tadalafil or vardenafil) during the study period (target population). Last observation carried forward method was used.||Percentage of participants|||Number
821091|NCT01150903|Primary|Percentage of Participants With New Diagnosis of Underlying Condition Between Day -92 and Day -1 Prior to the Index PDE5i Prescription|New diagnosis of underlying condition was defined as any new diagnosis of interest recorded in the relevant time period. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders.|Day -92 up to Day -1 of index prescription|Evaluable analysis population included all participants who received an index PDE5i prescription (sildenafil, tadalafil or vardenafil) during the study period (target population). Last observation carried forward method was used.||Percentage of participants|||Number
821092|NCT01150903|Primary|Cumulative Percentage of Participants With New Diagnosis of Underlying Condition Between Index PDE5i Prescription (Day 0) and Day 91|New diagnosis of underlying condition at prescription was defined as any new diagnosis of interest recorded in the relevant time period. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders.|Day 0 to Day 91 post index prescription|Evaluable analysis population included all participants who received an index PDE5i prescription (sildenafil, tadalafil or vardenafil) during the study period (target population) and age-matched participants without any PDE5i prescription during the study period (control population). Last observation carried forward method was used.||Percentage of participants|||Number
821093|NCT01150903|Primary|Percentage of Participants With Underlying Condition Until Day -1 of the Index PDE5i Prescription|Underlying conditions were defined as any diagnosis of interest recorded in the relevant time period. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders.|Day -92 up to Day -1 of index prescription|Evaluable analysis population included all participants who received an index PDE5i prescription (sildenafil, tadalafil or vardenafil) during the study period (target population) and age-matched participants without any PDE5i prescription during the study period (control population). Last observation carried forward method was used.||Percentage of participants|||Number
821094|NCT01150981|Secondary|Serum Adiponectin|Adiponectin concentrations in serum were measured in ng/ml, in both arms at baseline and at 8 weeks, i.e. 2 weeks after stopping drug or placebo treatment|8 weeks|||ng/ml||Standard Error|Mean
821121|NCT01151189|Secondary|CD4+ Lymphocyte Counts Before and After Administration of MVA85A/AERAS-485 Compared to Placebo in ART+ Subjects||Up to 6 months post second vaccination.|"Safety:
All randomized ART positive subjects who received a dose of study vaccine, based on actual treatment received."||cells/mm^3||Standard Deviation|Geometric Mean
821095|NCT01150981|Primary|Adipose Tissue Capillary Sprout Formation|Adipose tissue collected at 8 weeks was cut into ~1mm pieces which were embedded in individual wells of a 96 well plate containing growth factor depleted Matrigel. Wells were filled with media supplemented with endothelial growth factors, replaced every second day. Values for each patient are expressed as the difference in the average number of capillary branches (sprouts) formed by each of approximately 50 explants between day 14 and day 7. The number of branches forming on the periphery (defined as at least three cells in a branch structure) was counted by two investigators at day 7 and 14.|8 weeks|The number of subjects was based on the power of calculations in being able to demonstrate a difference from baseline in fat tissue microvasculature, change in HOMA2 and serum adiponectin after 6 weeks of rosiglitazone intake in all groups.||number of capillary sprouts||Standard Deviation|Mean
821096|NCT01151020|Primary|Patients With Device Failures|Device failure is defined as: Technical failure (inability to access or deploy the Zenith® TX2® Low Profile TAA Endovascular Graft or loss of patency at the time of deployment completion), or any of the following: type I or type III endoleaks requiring re-intervention, aneurysm rupture or conversion to open surgical repair, aneurysm enlargement greater than 0.5 cm.|12 months|||participants|||Number
821097|NCT01151020|Primary|Patients With Major Adverse Events (MAE)|"Major adverse event is defined as:
All-cause death; Q-wave MI; cardiac event involving arrest, resuscitation, or balloon pump; ventilation > 72 hours or re-intubation; pulmonary event requiring tracheostomy or chest tube; renal failure requiring permanent dialysis, hemofiltration, or kidney transplant in a patient with a normal pre-procedure serum creatinine level; bowel resection; stroke; paralysis; amputation involving more than toes; aneurysm or vessel leak requiring re-operation; deep vein thrombosis requiring surgical or lytic therapy; pulmonary embolism involving hemodynamic instability or surgery; coagulopathy requiring surgery; or wound complication requiring return to the operating room."|30 days|1 patient had a stroke and required ventilation >72 hours/reintubation.||participants|||Number
821098|NCT01151046|Secondary|Overall Survival|To determine whether MM-121 + exemestane is more effective than placebo + exemestane in prolonging overall survival. This was a time-to-event analysis of time from first dose to date of death.|Time from first dose to date of death, over approximately 2 years|||weeks||95% Confidence Interval|Median
821099|NCT01151046|Post-Hoc|To Explore the Utility of an EGFR Family Receptor-ligand (Heregulin, HRG) as a Predictor of Response to MM-121 and /or Exemestane in Formalin Fixed (FFPE) Tumor Samples|Fresh tumor samples were obtained from patients prior to enrollment and formalin-fixed for analysis. Samples were analyzed using RT-PCR for the expression of the biomarker, heregulin. Progression-free survival was assessed using RECIST v 1.1 to determine whether patients whose tumors express HRG have a lower PFS than those whose tumors do not express HRG, and to assess whether the addition of MM-121 to exemestane can increase PFS in HRG-high patients.|Time from first dose to date of progression, the longest time frame of 79.1 weeks|Patients with available tissue for RT-PCR analysis||months PFS||95% Confidence Interval|Median
821100|NCT01151046|Primary|Progression Free Survival (PFS)|"To determine whether MM-121 + exemestane was more effective than placebo + exemestane in prolonging progression-free survival. PFS was a time to event measure, and progression of disease is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Progression free survival was defined as the number of months from the date of randomization to the date of death or progression. If neither death nor progression was observed during the study, PFS data was censored at the last non-progressive disease valid tumor assessment unless the patient was discontinued due to symptomatic deterioration. If this occurred, the patient was counted as having progressive disease (PD)."|Time from first dose to date of progression, the longest time frame of 79.1 weeks|||weeks||95% Confidence Interval|Median
821101|NCT01151085|Secondary|Number of Participants That Responded to Voriconazole Treatment -Severity of Infections.|Number of participants that responded to voriconazole to determine whether severity of infections(mild, moderate or severe) is significant risk factor.|16 weeks|The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
821102|NCT01151085|Secondary|Risk Factors for the Frequency of Treatment Related Adverse Events -Past History.|Number of participants with Treatment Related Adverse Events of Voriconazole to determine whether with or without Past History is significant risk factor.|16 weeks|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.||participants|||Number
821103|NCT01151085|Secondary|Risk Factors for the Frequency of Treatment Related Adverse Events -Severity of Infections.|Number of participants with Treatment Related Adverse Events of Voriconazole to determine whether severity of infections(mild, moderate or severe) is significant risk factor.|16 weeks|||participants|||Number
821104|NCT01151085|Secondary|Risk Factors for the Frequency of Treatment Related Adverse Events -Gender.|Number of participants with Treatment Related Adverse Events of Voriconazole to determine whether male or female is significant risk factor.|16 weeks|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.||participants|||Number
821105|NCT01151085|Secondary|Number of Unlisted Treatment Related Adverse Events in Japanese Package Insert.|Adverse events mean all unfavorable events that occur in participants after administration of Voriconazole, irrespective of causal relationship to Voriconazole (including clinically problematic abnormal changes in laboratory test values). Number of Treatment Related Adverse Events were evaluated in company with the causal relationship to Voriconazole. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert.|16 weeks|No statistical analysis provided for the number of the unlisted treatment related adverse events in Japanese Package Insert.||events|||Number
821106|NCT01151085|Primary|Number of Participants That Responded to Voriconazole Treatment.|The primary endpoint was the efficacy ratio (number of effective cases/number of evaluable cases for efficacy assessment) among the cohort comprising the subjects for efficacy analysis.|16 weeks|The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
829371|NCT01226706|Secondary|Frequency of Participants With Urinary Tract Infections From Baseline to 6 Months|Frequency of particiapnts with urinary tract infections from baseline to 6 month-follow-up|Baseline to 6 months|||Participants|||Count of Participants
821107|NCT01151085|Primary|Number of Participants With the Frequency of Treatment Related Adverse Events.|Adverse events mean all unfavorable events that occur in participants after administration of Voriconazole, irrespective of causal relationship to Voriconazole (including clinically problematic abnormal changes in laboratory test values). Treatment related Adverse Events were evaluated in company with the causal relationship to Voriconazole.|16 weeks|No statistical analysis provided for the frequency of treatment related adverse events.||participants|||Number
821108|NCT01151098|Primary|Number of Participants With Adverse Events (AEs) as a Measure of Safety.|Safety was assessed using reports of all new adverse events (AEs) that occurred after the first application of a patch during the extension phase were recorded.|28 weeks|The Extension Safety population (N = 189) includes all subjects who were exposed to BTDS during the Open-label Extension Phase and provided at least 1 valid safety assessment after exposure to BTDS during the Open-label Extension Phase.||participants|||Number
821109|NCT01151137|Other Pre-specified|Overview of Adverse Events [AE]|AE are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.|from first study drug intake up to 10 days after the last study drug intake|Safety population: all randomized and treated participants. Participants were considered according to the treatment actually received. Consequently the participant randomized to the placebo group who received Dronedarone was included in the Dronedarone group.||participants|||Number
821110|NCT01151137|Other Pre-specified|Overview of Cardiovascular Events||From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year)|Intent-to-treat population as previously defined||participants|||Number
821111|NCT01151137|Secondary|Time to Cardiovascular Death (Cumulative Incidence Function)|"Time to cardiovascular death was defined as the time from randomization to the death.
Cumulative incidence function in each treatment group was calculated using non-parametric Kaplan-Meier estimate.
95% confidence interval was computed at each time-point using Greenwood's variance estimation."|From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year)|Intent-to-treat population as previously defined||proportion of participants||95% Confidence Interval|Number
821112|NCT01151137|Secondary|Deaths|Deaths were classified according to the primary cause of death.|From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year)|Intent-to-treat population as previously defined||participants|||Number
821113|NCT01151137|Primary|Time to Second Co-primary Outcome (Cumulative Incidence Function)|"Time to second co-primary outcome was defined as the time from randomization to the first event among unscheduled cardiovascular hospitalization or death from any cause.
Cumulative incidence function in each treatment group was calculated using non-parametric Kaplan-Meier estimate.
95% confidence interval was computed at each time-point using Greenwood’s variance estimation."|From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year)|Intent-to-treat population as previously defined||proportion of participants||95% Confidence Interval|Number
821114|NCT01151137|Primary|Time to First Co-primary Outcome (Cumulative Incidence Function)|"Time to first co-primary outcome was defined as the time from randomization to the first event among stroke, systemic arterial embolism, MI or cardiovascular death.
Cumulative incidence function in each treatment group was calculated using non-parametric Kaplan-Meier estimate.
95% confidence interval was computed at each time-point using Greenwood’s variance estimation."|From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year)|Intent-to-treat population as previously defined||proportion of participants||95% Confidence Interval|Number
821115|NCT01151137|Primary|Overview of the Two Co-primary Outcomes|"First co-primary outcome was defined as the first event among stroke, systemic arterial embolism, Myocardial Infarctions [MI], or cardiovascular death.
Second co-primary outcome was defined as the first event among unscheduled cardiovascular hospitalization or death from any cause.
Both co-primary outcomes were determined based on the central review and adjudication by a blinded Adjudication Committee of all reported deaths (from any cause), MI, systemic arterial embolisms, strokes, Transient Ischemic Attacks [TIA], Heart Failure hospitalization and unplanned hospitalisations for cardiovascular cause."|From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year)|Intent-to-treat population: All randomized participants considered in the treatment group to which they were randomized regardless of the treatment they actually received||participants|||Number
821116|NCT01151189|Secondary|QuantiFERON (QFN) Conversion Rate in MVA85A/AERAS-485 Recipients Compared to Control Subjects Without a Diagnosis of Tuberculosis During the Trial.||For at least 6 months post second vaccination up to 33 months total follow-up.|"Per protocol:
All randomized subjects who received a dose of study vaccine and had no major protocol deviations, were still ongoing in the study 28 days after Study Day 0, and did not have TB diagnosed within 28 days after Study Day 0 (QFT negative at baseline subgroup)."||participants who converted|||Number
821117|NCT01151189|Secondary|Immunogenicity of MVA85A/AERAS-485 Compared to Placebo as Described by Flow Cytometric Intracellular Cytokine Staining (ICS) of CD4+ and CD8+ T Cells After Stimulation With a Peptide Pool of Mycobacterial Antigens.|The antigen-specific negative control-subtracted response for any cytokine (Interferon gamma [INFγ] , Interleukin 2 [IL2], Interleukin 17 [IL17] and tumor necrosis factor [TNF]).|7 days post second vaccination.|First 70 patients enrolled who also had pre-vaccination results available were analyzed.||Percent responding TCells||95% Confidence Interval|Median
821118|NCT01151189|Secondary|Counts of Spot-forming Units After Stimulation With AG85A Peptide Pool.|Immunogenicity of MVA85A/AERAS-485 compared to placebo as described by the ex vivo interferon (IFN)-γ enzyme linked immunospot (ELISpot).|28 days post second vaccination.|First 70 patients enrolled who also had pre-vaccination results available were analyzed.||SFU - background/10^6 PBMC||95% Confidence Interval|Median
821119|NCT01151189|Secondary|HIV-1 Viral Load Before and After Administration of MVA85A/AERAS-485 Compared to Placebo in ART+ Participants.||Up tp 6 months post second vaccination|"Safety:
All randomized ART + subjects who received a dose of study vaccine, based on actual treatment received."||copies/mL||Standard Deviation|Geometric Mean
821120|NCT01151189|Secondary|HIV-1 Viral Load Before and After Administration of MVA85A/AERAS-485 Compared to Placebo in ART - Participants||Up to 6 months post second vaccination.|"Safety:
All randomized ART - subjects who received a dose of study vaccine, based on actual treatment received."||copies/mL||Standard Deviation|Geometric Mean
829372|NCT01226706|Secondary|Frequency of Participants Needing Self-catheterization From Baseline to 6 Month Follow-up|Frequency of participants needing self-catheterization from baseline to 6 month follow-up.|Baseline to 6 months|||Participants|||Number
821122|NCT01151189|Secondary|CD4+ Lymphocyte Counts Before and After Administration of MVA85A/AERAS-485 Compared to Placebo in Anti-retroviral Therapy Negative (ART -)Subjects||Up to 6 months post second vaccination.|"Safety:
All randomized ART negative subjects who received a dose of study vaccine, based on actual treatment received."||cells/mm^3||Standard Deviation|Geometric Mean
821123|NCT01151189|Secondary|Number of TB Cases|Efficacy of MVA85A/AERAS-485 in the prevention of TB disease compared to control subjects who received placebo in HIV-infected, African adult subjects without active TB disease.|For at least 6 months post second vaccination up to 33 months total follow-up.|"Per protocol:
All randomized subjects who received a dose of study vaccine and had no major protocol deviations, were still ongoing in the study 28 days after Study Day 0, and did not have TB diagnosed within 28 days after Study Day 0."||participants with TB|||Number
821124|NCT01151189|Primary|Percentage of Participants With Adverse Events|The primary objective of this study is to evaluate the safety of MVA85A/AERAS-485 compared to placebo in HIV-infected, African adult subjects without active TB disease.|Adverse Events (AEs) are recorded for 28 days post vaccination, Serious Adverse Events (SAEs) for at least 6 months post second vaccination.|"Safety:
All randomized subjects who received a dose of study vaccine, based on actual treatment received."||percentage of participants with an AE|||Number
821125|NCT01151215|Secondary|Compare the Overall Survival in Patients Treated With AZD8931 in Combination With Anastrozole Versus Anastrozole Alone|Time from the date of randomization to the date of death (by any cause)|Following progression, patients were contacted at 12 weekly intervals until data cut-off at 31 August 2012 to determine survival status|Full Analysis Set (all participants randomized, irrespective of whether treatment was received). Participants are analysed according to the treatment group they were randomized to.||Months|Participants|Inter-Quartile Range|Median
821126|NCT01151215|Primary|Progression Free Survival as Evaluated by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1|Time from the date of randomization until the date of objective disease progression (as per RECIST 1.1) or the date of death (by any cause in the absence of progression). Disease progression is defined using RECIST 1.1 as >=20% increase in the sum of longest diameters of target lesions and an absolute increase of >=5mm, taking as reference the smallest sum of longest diameters of target lesions since study start, or unequivocal progression in non-target lesions, or appearance of any new lesions.|Tumour assessment by RECIST 1.1 every 12 weeks until data cut-off at 31 August 2012|Full Analysis Set (all participants randomized, irrespective of whether treatment was received). Participants are analysed according to the treatment group they were randomized to.||Months|Participants|Inter-Quartile Range|Median
821127|NCT01151280|Secondary|Time to Stent Occlusion|"Evidence of stent occlusion
stent occlusion was assessed during the stent indwell period (from stent placement procedure through the stent removal procedure. 3 months according to protocol). Subjects received liver function tests at the 48 hour, Week 1, Month 1, and Month 3 stent indwell follow-up visits and were also asked if they were experiencing biliary obstructive symptoms at each visit. If stent occlusion was suspected, imaging and/or endoscopic intervention was performed. One subject experienced stent occlusion at 68 days post stent placement. Time to event data was not generated as not enough events occurred to calculate medial time to event data."|mean time from stent placement to stent removal for all 10 patients was 91.3 days.|"All participants were included for analysis.
1/10 subjects experienced stent occlusion at 68 days post stent placement. Mean time to event data was not calculated as only 1 stent occlusion occurred in 10 subjects."||days|||Number
821128|NCT01151280|Secondary|Re-intervention Occurrence|Evaluation of the occurrence of re-intervention. Re-intervention is defined as any type of endoscopic, percutaneous, or surgical procedure to improve biliary drainage during stent indwell or through 6 months of follow-up after stent removal.|6 months post stent removal|All participants were included for analysis.||participants|||Number
821129|NCT01151280|Secondary|Effectiveness of Stent at 6 Months|"Evaluation of effectiveness of the stent by assessing for resolution of stricture at 6 months as determined by cholangiogram.
Effectiveness is defined as the absence of biliary obstructive symptoms after receiving a WallFlex stent.
Subjects received liver function tests at the 1 Month and 6 Month post stent removal follow-up visits and were also assessed for biliary obstructive symptoms."|From stent removal through 6 months post stent removal follow-up.|Effectiveness was assessed in 9 participants that had stricture resolution at the time of stent removal. 1 participant did not have resolution at removal and therefore could not be assessed in the post stent removal follow-up period.||participants|||Number
821130|NCT01151280|Secondary|Technical Success of Stent Placement|Evaluation of technical success of the stent placement defined as the ability to deploy the stent in satisfactory position across the stricture as determined by cholangiogram.|At stent placement (Day 1)|All participants were included for analysis.||participants|||Number
821131|NCT01151280|Secondary|Stent Removability|Stent removability is measured as the ability to successfully remove the stent at initial placement in case of inadequate stent placement, during the stent indwell period in case of stent failure, or at the end of indwell without any clinically significant complications or technical difficulties. A clinically significant complication is defined as a medical event that requires an intervention.|At 3 months (per protocol removal) or early removal|All participants were included for analysis.||participants|||Number
821132|NCT01151280|Secondary|Safety|"Safety is being measured by the occurrence, severity, device- and procedure-relatedness of adverse events during stent placement, during stent indwell, at the time of stent removal, and after stent removal.
Unit of measure will be the actual number of adverse events that occurred."|From enrollment through end of study.|All participants were included for analysis.||adverse events|||Number
821133|NCT01151280|Primary|Stricture Resolution at the Time of Stent Removal.|Stricture resolution is assessed at the time of stent removal. Stricture resolution is confirmed by cholangiogram and/or balloon sweep of the biliary duct. Stent removal can be per-protocol (3 months indwell) or early.|At 3 months (per protocol removal) or at early removal.|All participants were included for analysis.||participants|||Number
821134|NCT01151345|Primary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post dose|PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||hr||Standard Deviation|Mean
829373|NCT01226706|Secondary|Frequency of Urinary Tract Infections From Baseline to 6 Months|Frequency of urinary tract infections from baseline to 6 month-follow-up|Baseline to 6 months|||number of occurences|||Number
821135|NCT01151345|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post dose|PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||hr||Standard Deviation|Mean
821136|NCT01151345|Primary|Maximum Observed Plasma Concentration (Cmax)||0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post dose|PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng/mL||Standard Deviation|Mean
821137|NCT01151345|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post dose|Pharmacokinetic (PK) parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng*hr/mL||Standard Deviation|Mean
821138|NCT01151345|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]|AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)|0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post dose|Pharmacokinetic (PK) parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng*hr/mL||Standard Deviation|Mean
821139|NCT01151371|Primary|Signs of Limbal Hyperemia Narafilcon B v. Lotrafilcon B|Redness scale of 0 to 4, where 0=None, and 4=Severe.|After 4 Weeks|||units on a scale|eyes|Standard Deviation|Mean
821140|NCT01151371|Secondary|Subjective Rating of Initial Comfort Narafilcon B v. Lotrafilcon B|Comfort immediately after the lens is put on the eye. Scale of 1 to 5, where 1=poor comfort, 5=excellent comfort.|After 4 Weeks|||units on a scale||Standard Error|Mean
821141|NCT01151371|Secondary|Subjective Rating of End of Day Comfort Narafilcon B v. Lotrafilcon B|Scale of 1 to 5, where 1=poor comfort and 5=excellent comfort|After 4 Weeks|||units on a scale||Standard Error|Mean
821142|NCT01151371|Secondary|Subjective Rating of Overall Ease of Lens Handling Narafilcon B v. Lotrafilcon B|Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.|After 4 Weeks|||units on a scale||Standard Deviation|Mean
821143|NCT01151371|Secondary|Signs of Inferior Corneal Staining Narafilcon B v. Lotrafilcon B|Scale of 0 to 3, where 0=none and 3=severe staining.|After 4 Weeks|||units on a scale||Standard Deviation|Mean
821144|NCT01151371|Secondary|Subjective Rating of Initial Comfort Narafilcon B v. Nelfilcon A|Comfort immediately after the lens is put on the eye. Scale of 1 to 5, where 1=poor comfort and 5=excellent comfort.|After 1 Week|||units on a scale||Standard Error|Mean
821145|NCT01151371|Secondary|Subjective Rating of End of Day Comfort Narafilcon B v. Nelfilcon A|Scale of 1 to 5, where 1=Poor comfort and 5=Excellent comfort|After 1 Week|||units on a scale||Standard Error|Mean
821146|NCT01151371|Secondary|Subjective Rating of Overall Ease of Lens Handling Narafilcon B v Nelfilcon A|Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.|After 1 Week|||units on a scale||Standard Deviation|Mean
821147|NCT01151371|Secondary|Signs of Inferior Corneal Staining Narafilcon B v. Nelfilcon A|Standard scale of 0 to 3 where 0=None, 3=Severe staining|After 1 Week|||units on a scale|eyes|Standard Deviation|Mean
821148|NCT01151371|Primary|Subjective Rating of Overall Comfort Narafilcon B v. Lotrafilcon B|Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.|After 4 Weeks|||units on a scale||Standard Deviation|Mean
821149|NCT01151371|Primary|Signs of Limbal Hyperemia Narafilcon B v. Nelfilcon A|Redness scale of 0 to 4, where 0=None, 4=Severe redness|After 1 Week|||Units on a scale|eyes|Standard Deviation|Mean
821150|NCT01151371|Primary|Overall Comfort Narafilcon B v. Nelfilcon A|Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.|After 1 week|||units on a scale||Standard Deviation|Mean
821151|NCT01151410|Secondary|Change in Mean Arterial Pressure (MAP) (mmHg) From Baseline to End of Study|MAP was defined as the average arterial pressure during a single cardiac cycle. The MAP was measured as sum of diastolic blood pressure (DBP) and one third of difference between systolic blood pressure (SBP) and DBP i.e. MAP = DBP+1/3*(SBP-­DBP).|Baseline to end of study (Week 52 or LOCF)|Full analysis set (FAS) included all randomized patients for this trial||mmHg||Standard Error|Least Squares Mean
821152|NCT01151410|Secondary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study|Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 2 to 3 minute intervals and the mean of three sDBP measurements were used as the average sitting office blood pressure for that visit.|Baseline - end of study (Week 52 or Last observation carried forward (LOCF)|Full analysis set (FAS) included all randomized patients for this trial||mmHg||Standard Error|Least Squares Mean
821171|NCT01151436|Secondary|PERIORBITAL LINES SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:
0: no wrinkles
just perceptible wrinkle
shallow wrinkle
moderately deep wrinkle
deep wrinkle, well-defined edges
very deep wrinkle redundant fold"|3 MONTHS AFTER LAST INJECTION|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)||units on a scale|Participants|Standard Deviation|Mean
821153|NCT01151410|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at to End of Study|Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 2 to 3 minute intervals and the mean of three sSBP measurements were used as the average sitting office blood pressure for that visit.|Baseline - end of study (Week 52 or Last observation carried forward (LOCF)|Full analysis set (FAS) included all randomized patients for this trial||millimeter(s) of mercury (mmHg)||Standard Error|Least Squares Mean
821154|NCT01151436|Secondary|LIP ENHANCEMENT ASSESSMENT|"Lip fullness grading scale score:
0: very thin lip
thin lip
moderately thick lip
thick lip
full lip"|6 MONTHS AFTER LAST INJECTION|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)||units on a scale|Participants|Standard Deviation|Mean
821155|NCT01151436|Secondary|LIP ENHANCEMENT ASSESSMENT|"Lip fullness grading scale score:
0: very thin lip
thin lip
moderately thick lip
thick lip
full lip"|3 MONTHS AFTER LAST INJECTION|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)||units on a scale|Participants|Standard Deviation|Mean
821156|NCT01151436|Secondary|LIP ENHANCEMENT ASSESSMENT|"Lip fullness grading scale score:
0: very thin lip
thin lip
moderately thick lip
thick lip
full lip"|3 WEEKS AFTER LAST INJECTION|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)||units on a scale|Participants|Standard Deviation|Mean
821157|NCT01151436|Secondary|LIP ENHANCEMENT ASSESSMENT|"Lip fullness grading scale score:
0: very thin lip
thin lip
moderately thick lip
thick lip
full lip"|baseline|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)||units on a scale|Participants|Standard Deviation|Mean
821158|NCT01151436|Secondary|CHEEK FOLDS SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:
0: no wrinkles
just perceptible wrinkle
shallow wrinkle
moderately deep wrinkle
deep wrinkle, well-defined edges
very deep wrinkle redundant fold"|6 MONTHS AFTER LAST INJECTION|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)||units on a scale|Participants|Standard Deviation|Mean
821159|NCT01151436|Secondary|CHEEK FOLDS SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:
0: no wrinkles
just perceptible wrinkle
shallow wrinkle
moderately deep wrinkle
deep wrinkle, well-defined edges
very deep wrinkle redundant fold"|3 MONTHS AFTER LAST INJECTION|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)||units on a scale|Participants|Standard Deviation|Mean
821160|NCT01151436|Secondary|CHEEK FOLDS SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:
0: no wrinkles
just perceptible wrinkle
shallow wrinkle
moderately deep wrinkle
deep wrinkle, well-defined edges
very deep wrinkle redundant fold"|3 WEEKS AFTER LAST INJECTION|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)||units on a scale|Participants|Standard Deviation|Mean
821161|NCT01151436|Secondary|CHEEK FOLDS SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:
0: no wrinkles
just perceptible wrinkle
shallow wrinkle
moderately deep wrinkle
deep wrinkle, well-defined edges
very deep wrinkle redundant fold"|BASELINE|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)||units on a scale|Participants|Standard Deviation|Mean
821162|NCT01151436|Secondary|UPPER LIP LINES SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:
0: no wrinkles
just perceptible wrinkle
shallow wrinkle
moderately deep wrinkle
deep wrinkle, well-defined edges
very deep wrinkle redundant fold"|6 MONTHS AFTER LAST INJECTION|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)||units on a scale|Participants|Standard Deviation|Mean
821163|NCT01151436|Secondary|UPPER LIP LINES SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:
0: no wrinkles
just perceptible wrinkle
shallow wrinkle
moderately deep wrinkle
deep wrinkle, well-defined edges
very deep wrinkle redundant fold"|3 MONTHS AFTER LAST INJECTION|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)||units on a scale|Participants|Standard Deviation|Mean
821164|NCT01151436|Secondary|UPPER LIP LINES SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:
0: no wrinkles
just perceptible wrinkle
shallow wrinkle
moderately deep wrinkle
deep wrinkle, well-defined edges
very deep wrinkle redundant fold"|3 WEEKS AFTER LAST INJECTION|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)||units on a scale|Participants|Standard Deviation|Mean
821165|NCT01151436|Secondary|UPPER LIP LINES SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:
0: no wrinkles
just perceptible wrinkle
shallow wrinkle
moderately deep wrinkle
deep wrinkle, well-defined edges
very deep wrinkle redundant fold"|BASELINE|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)||units on a scale|Participants|Standard Deviation|Mean
821166|NCT01151436|Secondary|MARIONETTE LINES SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:
0: no wrinkles
just perceptible wrinkle
shallow wrinkle
moderately deep wrinkle
deep wrinkle, well-defined edges
very deep wrinkle redundant fold"|6 MONTHS AFTER LAST INJECTION|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)||units on a scale|Participants|Standard Deviation|Mean
821167|NCT01151436|Secondary|MARIONETTE LINES SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:
0: no wrinkles
just perceptible wrinkle
shallow wrinkle
moderately deep wrinkle
deep wrinkle, well-defined edges
very deep wrinkle redundant fold"|3 MONTHS AFTER LAST INJECTION|ININTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)||units on a scale|Participants|Standard Deviation|Mean
821168|NCT01151436|Secondary|MARIONETTE LINES SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:
0: no wrinkles
just perceptible wrinkle
shallow wrinkle
moderately deep wrinkle
deep wrinkle, well-defined edges
very deep wrinkle redundant fold"|3 WEEKS AFTER LAST INJECTION|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)||units on a scale|Participants|Standard Deviation|Mean
821169|NCT01151436|Secondary|MARIONETTE LINES SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:
0: no wrinkles
just perceptible wrinkle
shallow wrinkle
moderately deep wrinkle
deep wrinkle, well-defined edges
very deep wrinkle redundant fold"|BASELINE|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)||units on a scale|Participants|Standard Deviation|Mean
821170|NCT01151436|Secondary|PERIORBITAL LINES SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:
0: no wrinkles
just perceptible wrinkle
shallow wrinkle
moderately deep wrinkle
deep wrinkle, well-defined edges
very deep wrinkle redundant fold"|6 MONTHS AFTER LAST INJECTION|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)||units on a scale|Participants|Standard Deviation|Mean
821746|NCT01155284|Secondary|2 Hour C-peptide AUC in Response to MMTT|Blood samples for C-peptide were collected at baseline (pre-meal) and 15, 30, 60, 90, and 120 minutes post-meal.|Month 6|Of the 70 subjects randomized, 58 completed treatment and analysis.||pmol/L||95% Confidence Interval|Median
821172|NCT01151436|Secondary|PERIORBITAL LINES SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:
0: no wrinkles
just perceptible wrinkle
shallow wrinkle
moderately deep wrinkle
deep wrinkle, well-defined edges
very deep wrinkle redundant fold"|3 weeks after last injection|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)||units on a scale|Participants|Standard Deviation|Mean
821173|NCT01151436|Secondary|PERIORBITAL LINES SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:
0: no wrinkles
just perceptible wrinkle
shallow wrinkle
moderately deep wrinkle
deep wrinkle, well-defined edges
very deep wrinkle redundant fold"|baseline|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)||units on a scale|Participants|Standard Deviation|Mean
821174|NCT01151436|Secondary|NASOLABIAL FOLDS SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:
0: no wrinkles
just perceptible wrinkle
shallow wrinkle
moderately deep wrinkle
deep wrinkle, well-defined edges
very deep wrinkle redundant fold"|6 months after last injection|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)||units on a scale|Participants|Standard Error|Mean
821175|NCT01151436|Secondary|NASOLABIAL FOLDS SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:
0: no wrinkles
just perceptible wrinkle
shallow wrinkle
moderately deep wrinkle
deep wrinkle, well-defined edges
very deep wrinkle redundant fold"|3 months after last injection|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)||units on a scale|Participants|Standard Deviation|Mean
821176|NCT01151436|Secondary|NASOLABIAL FOLDS SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:
0: no wrinkles
just perceptible wrinkle
shallow wrinkle
moderately deep wrinkle
deep wrinkle, well-defined edges
very deep wrinkle redundant fold"|3 weeks after last injection|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)||units on a scale|Participants|Standard Deviation|Mean
821177|NCT01151436|Primary|Full Face Global Aesthetic Improvement|"Global aesthetic improvement scale score from baseline:
-1: worse 0: no change
improved
much improved
very much improved"|6 months after last injection|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)||units on a scale||Standard Deviation|Mean
821178|NCT01151436|Primary|Full Face Global Aesthetic Improvement|"Global aesthetic improvement scale score from baseline:
-1: worse 0: no change
improved
much improved
very much improved"|3 months after last injection|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)||units on a scale||Standard Error|Mean
821179|NCT01151436|Secondary|NASOLABIAL FOLDS SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:
0: no wrinkles
just perceptible wrinkle
shallow wrinkle
moderately deep wrinkle
deep wrinkle, well-defined edges
very deep wrinkle redundant fold"|baseline|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)||units on a scale|Participants|Standard Deviation|Mean
821180|NCT01151436|Primary|Full Face Global Aesthetic Improvement|"Global aesthetic improvement scale score from baseline:
-1: worse 0: no change
improved
much improved
very much improved"|3 weeks after last injection|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)||units on a scale||Standard Deviation|Mean
821181|NCT01151449|Secondary|Overall Survival|Computed using the Kaplan-Meier method.|Within the protocol defined follow-up period.|Inadequate data for OS estimates as only 6 patients were accrued in the study.|||||
821182|NCT01151449|Secondary|Duration of Radiologic Response|The duration of radiologic response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented.|From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented.|||months|||Number
821183|NCT01151449|Secondary|Progression-free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the diameters of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Computed using the Kaplan-Meier method.|Time from start of study treatment to the date of first progression or death from any cause, whichever occurs first, assessed at 3 months|Inadequate data for PFS estimates as only 6 patients were accrued in the study.|||||
821184|NCT01151449|Primary|Progression-free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the diameters of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Computed using the Kaplan-Meier method.|Time from start of study treatment to the date of first progression or death from any cause, whichever occurs first, assessed at 6 months|Inadequate data for PFS estimates as only 6 patients were accrued in the study.|||||
821185|NCT01151449|Primary|Overall Response Rate Using RECIST|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the diameters of target lesions; Overall Response (OR) = CR + PR.|From start of treatment until disease progression or removal from treatment.|||participants|||Number
821186|NCT01151553|Primary|Comparison of Markers of Oxidative Stress Pre and Post Cardiac Resynchronization Therapy as Outcome|Patient has a weak heart and scheduled to have CRT placed in the next month. The study is to evaluate blood markers which may predict which patients who receive CRT will improve|One year|Early termination leading to small numbers of subjects; lost funding and staff, no data collected/processed.|||||
821187|NCT01145001|Secondary|Continuous Abstinence During Treatment|We will also examine continuous abstinence during the six week treatment period by urine analysis each week.|6 weeks|this is the intent to treat group-all starters (not treatment completers)||consecutive days of abstinence||Standard Deviation|Mean
821188|NCT01145001|Primary|Abstinence Rates at the End of Treatment|Our primary outcome will be point prevalence abstinence at the end of the treatment period defined as any self-report of cigarette use during the seven days prior to the last appointment confirmed by urine analysis.|6 weeks|||percentage of participants not smoking|||Number
821189|NCT01145053|Secondary|Nocturnal Sleep|Nocturnal Sleep is rating 1 to 5 score based on patient’s diary: 1=Sputum and cough hardly made me awake; 2=Sputum and cough only one time made me awake; 3=Sputum and cough 2 or 3 times made me awake; 4=Sputum and cough 4 to 6 times made me awake; 5=Sputum and cough made me awake all night.|Week 0 and Week 52|The 25 patients which were non approved indication patients and no efficacy information, were excluding from safety set, 316 patients were included in efficacy set. In the efficacy set, 308 patients recorded the Nocturnal Sleep.||Units on a scale||Standard Deviation|Mean
821190|NCT01145053|Secondary|Shortness of Breath|Shortness of Breath is rating 1 to 6 score based on patient’s diary: 1=No shortness of breath and no problem in activity in daily life (ADL); 2=Despite shortness of breath, can move about like other people of the same age and no problem in ADL; 3=Can walk fast for a short time but activities like other people of the same age are not possible; 4=Can walk normally, go up the stairs slowly but quick motion is difficult; 5=Can walk slowly in the neighborhood but shortness of breath occurs; 6= Due to severe shortness of breath, rested at home all day.|Week 0 and Week 52|The 25 patients which were non approved indication patients and no efficacy information, were excluding from safety set, 316 patients were included in efficacy set. In the efficacy set, 309 patients recorded the Shortness of Breath.||Units on a scale||Standard Deviation|Mean
821191|NCT01145053|Secondary|Amount of Sputum|Amount of Sputum is rating 1 to 4 score based on patient’s diary: 1= None; 2= Slight; 3=Slightly more; 4= Very much.|Week 0 and Week 52|The 25 patients which were non approved indication patients and no efficacy information, were excluding from safety set, 316 patients were included in efficacy set. In the efficacy set, 309 patients recorded the Amount of Sputum.||Units on a scale||Standard Deviation|Mean
821192|NCT01145053|Secondary|Cough Frequency|Cough frequency is rating 1 to 4 score based on patient’s diary: 1=None; 2=A few times; 3=Frequently; 4=Very frequently.|Week 0 and Week 52|The 25 patients which were non approved indication patients and no efficacy information, were excluding from safety set, 316 patients were included in efficacy set. In the efficacy set, 309 patients recorded the Cough Frequency .||Units on a scale||Standard Deviation|Mean
821193|NCT01145053|Secondary|Forced Expiratory Volume in One Second (FEV1)|FEV1 is observed at Week 0 and Week 52. The change of FEV1 from Week 0 to Week 52 is calculated.|Week 0 and Week 52|The 25 patients which were non approved indication patients and no efficacy information, were excluding from safety set, 316 patients were included in efficacy set. In the efficacy set, 105 patients measured FEV1 .||L||Standard Deviation|Mean
821194|NCT01145053|Secondary|Effectiveness|Effectiveness should be comprehensively investigated based on the items of patients observation, test results of FEV1, clinical symptoms. The Effectiveness is classified into 3 category, 'Improved', 'No change' and 'Aggravated' by physician.|Week 52|The 25 patients which were non approved indication patients and no efficacy information, were excluding from safety set, 316 patients were included in efficacy set.||Patients|||Number
821195|NCT01145053|Primary|Incidence of Adverse Events (AEs)|The number of patient with any AEs, patients with drug-related AEs|Week 52|The all treated patients||Patients|||Number
821196|NCT01151579|Secondary|Total Number of Participants With Arrhythmias|Documented new arrhythmia occurring during study.|Five days|Number of patients for whom arrhythmias occurred within 5 days after treatment initiation.||participants|||Number
821197|NCT01151579|Secondary|Arrhythmias|Any new arrhythmia documented in the medical record that occurred between breathing treatments.|15 minutes after each treatment for average of 3 to 5 days|The percentage of arrhythmias among the number of breathing treatments.||percent|||Number
821198|NCT01151579|Primary|Heart Rate in Beats Per Minute|Average difference in Heart rate between pre and post breathing treatments|Five days|Average change in heart rate from baseline to final breathing treatment.||bpm|Participants|Standard Deviation|Mean
821199|NCT01151761|Secondary|Median Time to Overall Survival|The time to overall survival is defined as the time to death from any cause. The median was determined via Kaplan Meier methodology.|18 months|||months||95% Confidence Interval|Median
821200|NCT01151761|Secondary|Liver Transplant Conversion Rate|The ability to successfully perform liver transplant among patients who initially have tumor >3 cm|12 months|||participants|||Number
821201|NCT01151761|Secondary|Freedom From Local Progression at 12 Months|the proportion of patients who experienced a local recurrence at 12 months with death as a competing risk|12 months|Neither of the two patients that participated in the study had a local recurrence prior to dying.||percentage of patients|||Number
821202|NCT01151761|Secondary|Liver Transplant Rate|The number of patients receiving liver transplant among patients who initially have tumors ≤3 cm|12 months|||participants|||Number
821203|NCT01151761|Secondary|Overall Survival at 12 Months|the estimated probability for the percentage of participants with overall survival at 12 months.|12 months|There were only two patients analyzed. Please take that under advisement when looking at the results.||probability|||Number
821204|NCT01151761|Secondary|Serum CA 19-9 Levels|Initial level of Cancer antigen 19-9|12 months|||U/ml||Full Range|Mean
821205|NCT01151761|Secondary|Pathologic Complete Response Rate|Pathologic complete response will be defined as no residual tumor cells seen on the explanted liver specimen.|12 months|||participants|||Number
821206|NCT01151761|Primary|Progression-free Survival at 12 Months|Progression free survival is defined to be the time to progression of disease or death.|12 months|||participants|||Number
821207|NCT01151852|Secondary|Safety and Tolerability of Imatinib|percentage of patients who experienced toxicity from study treatment to evaluate the safety and tolerability of imatinib re-challenge in this patient population|Up to 3years|||percentage of participants|||Number
821208|NCT01151852|Secondary|Overall Survival(OS) and Time to Progression(TTP)|To compare the overall survival (OS) and time to progression (TTP) in both arms of the study|Up to 3years|||Months||95% Confidence Interval|Median
821209|NCT01151852|Secondary|Response Rate|"Tumour responses were initially determined by the local investigators in accordance with RECIST 1.0.Treatment decisions were based on local onsite radiological review. All imaging data were subsequently collected, anonymised, and reviewed centrally in a double-blind manner by two external academic radiology reviewers.
Response assessment was determined in a masked central review by use of RECIST1.1."|Up to 12weeks|||percentage of participants|||Number
821210|NCT01151852|Secondary|Progression Free Survival|To compare PFS assessed by investigators|up to 12 weeks|||Months||95% Confidence Interval|Median
821211|NCT01151852|Secondary|Disease Control Rate|"Inclusion of complete response, partial response or stable disease
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR; Progressive disease (PD), >20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD), Insufficient change to qualify for PR or PD."|up to 12 weeks|||percentage of participants|||Number
829374|NCT01226706|Secondary|24 Hour Pad Weight (gm) at 9 Months|weight of pad (in gm) worn for 24 hours to detect urine loss|9 months|||gm||Standard Deviation|Mean
821212|NCT01151852|Primary|Progression-free Survival|To compare the progression free survival (PFS) assessed by the blinded independent central review following resumption of dosing (re-challenge) with Imatinib plus best supportive care versus placebo plus best supportive care in patients with unresectable or metastatic GIST following failure of at least prior imatinib and sunitinib therapies|up tp12 weeks|||Months||95% Confidence Interval|Median
821213|NCT01152697|Secondary|Adherence Attitude Score as Measured by the Attitude Toward Medication Questionnaire (AMQ) at 12 Months|Nineteen item inventory taken by the participant with Scale Range:0-19. Lower scores indicate improved outcomes.|12 months|Seven participants were administered and completed this measure at 12 months.||units on a scale||Standard Deviation|Mean
821214|NCT01152697|Secondary|Treatment Adherence Behavior Score as Measured by the Morisky Medication Rating Scale at 12 Months|Four item inventory taken by participant with Scale Range: 0-4. Lower scores indicate better outcomes.|12 months|Six participants were administered and completed this measure at 12 months.||units on a scale||Standard Deviation|Mean
821215|NCT01152697|Secondary|Adherence Attitude Score as Measured by the Drug Attitude Inventory (DAI) at 12 Months|Ten item inventory taken by the participant with a Scale Range: 0-10. Higher scores indicate improved outcomes.|12 months|Six participants were administered and completed this measure at 12 months.||units on a scale||Standard Deviation|Mean
821216|NCT01152697|Secondary|Treatment Adherence Score as Measured at 12 Months|A total treatment adherence score will calculated as a proportion of medications taken as reported from the participant, and evidenced by pill counts and documented medication injections.|12 months|Seven participants were administered and completed this measure at 12 months.||Percentage of doses||Standard Deviation|Mean
821217|NCT01152697|Secondary|Days Homeless Out of the Previous 6 Months as Measured at 12 Months|Subjects will be asked how many days they have been homeless|12 months|Six participants were administered and completed this measure at 12 months.||days||Standard Deviation|Mean
821218|NCT01152697|Secondary|Treatment Satisfaction as Measured by the Participant Acceptability and Satisfaction Questionnaire at 12 Months|"Satisfaction will be measured by a seven item inventory taken by the participant.
Scale ranges from 1 (Strongly Agree) to 5 (Strongly Disagree). Lower scores indicate better outcomes, while higher scores indicate worse outcomes. The highest possible score is 35."|12 months|Six participants were administered and completed this measure at 12 months.||units on a scale||Standard Deviation|Mean
821219|NCT01152697|Secondary|Change in Social and Occupational Functioning Scale (SOFAS) as Measured at 12 Months|Life and Work Functional status will be evaluated using the Social and Occupational Functioning Scale (SOFAS), which is derived from the GAF. The GAF is a 100-point single-item scale which measures global functioning of psychiatric patients and is widely utilized in clinical studies involving Seriously Mentally Ill patients (Jones 1995). The reliability of the GAF ranges from 0.62-0.82. Higher scores indicate improved outcomes.|Baseline-12 months|Six participants were administered and completed measurement with the SOFAS at 12 months. Only data for these participants was analyzed for change from baseline to 12 months.||units on a scale||Standard Deviation|Mean
821220|NCT01152697|Secondary|Global Psychopathology as Measured by the Clinical Global Impressions (CGI) at 12 Months|"Global psychopathology will be measured with the Clinical Global Impressions (CGI) (Guy 1976) a widely used scale which evaluates illness severity on a 1 to 7 point continuum. Severity of illness ratings on the CGI have reported reliability scores ranging from 0.41-0.66 (Guy 1976) Lower scores indicate improved outcomes. Higher scores indicate worse outcomes.
Illness scale: 1 - 7 (1 = Normal/not at all ill ; 7 = Among the most extremely ill patients) Global improvement scale: 1 - 7 (1 = Very much improved ; 7 = Very much worse)"|12 months|12 participants were administered and completed measurement with the CGI at 12 months.||units on a scale||Standard Deviation|Mean
821221|NCT01152697|Secondary|Frequency of Health Resource Use in the Past 3 Months as Measured at 25 Weeks|The frequency of health resource use will be measured through interview of the participant.|25 weeks|17 participants were administered and completed this measure at week 25.||days||Standard Deviation|Mean
821222|NCT01152697|Secondary|Change in Schizophrenia and Schizoaffective Disorder Symptom Severity Scale as Measured by the Positive and Negative Syndrome Scale (PANSS) at 25 Weeks|"The PANSS (Kay, Fiszbein, & Opler 1987) was created to assess both the positive and negative symptoms of schizophrenia such as hallucinations and emotional withdrawal, respectively. The scale rates 30 symptoms on a scale from 1 (absent) to 7 (extreme) and has been shown to limit bias between the assessment of positive and negative symptoms, providing a broad but balanced spectrum of the illness.
There are three subscales: positive symptoms, negative symptoms, general psychopathology. Potential responses to Items on all subscales range from 1 (absent) to 7 (extreme). Lower scores indicate lower symptoms and, therefore, better outcomes. Higher scores indicate more presence of symptoms and, therefore, worse outcomes.
Subscales are combined to produce a total score, which is summed from all of the subscales. Lower total scores indicate lower symptoms and, therefore, better outcomes. Higher total scores indicate more presence of symptoms and, therefore, worse outcomes."|Baseline-25 weeks|19 participants were administered and completed measurement with the PANSS at week 25. Only data for these participants was analyzed for change from baseline to week 25.||units on a scale||Standard Deviation|Mean
821223|NCT01152697|Secondary|Treatment Satisfaction as Measured by the Participant Acceptability and Satisfaction Questionnaire at 25 Weeks|"Satisfaction will be measured by a seven item inventory taken by the participant.
Scale ranges from 1 (Strongly Agree) to 5 (Strongly Disagree). Lower scores indicate better outcomes, while higher scores indicate worse outcomes. The highest possible score is 35."|25 weeks|17 participants were administered and completed this measure at week 25.||units on a scale||Standard Deviation|Mean
821224|NCT01152697|Secondary|Change in Social and Occupational Functioning Scale (SOFAS) as Measured at 25 Weeks|Life and Work Functional status will be evaluated using the Social and Occupational Functioning Scale (SOFAS), which is derived from the GAF (Global Assessment of Functioning). The GAF is a 100-point single-item scale which measures global functioning of psychiatric patients and is widely utilized in clinical studies involving Seriously Mentally Ill patients (Jones 1995). The reliability of the GAF ranges from 0.62-0.82. Higher scores indicate improved outcomes.|Baseline-25 weeks|17 participants were administered and completed measurement with the SOFAS at week 25. Only data for these participants was analyzed for change from baseline to week 25.||units on a scale||Standard Deviation|Mean
821747|NCT01155284|Primary|2 Hour C-peptide AUC in Response to MMTT|Blood samples for C-peptide were collected at baseline (pre-meal) and 15, 30, 60, 90 and 120 minutes post-meal.|Month 12|Of the 70 subjects randomized, 58 completed treatment and analysis.||pmol/L||95% Confidence Interval|Median
821225|NCT01152697|Secondary|Change in Global Psychopathology as Measured by the Clinical Global Impressions (CGI) at 25 Weeks|"Global psychopathology will be measured with the Clinical Global Impressions (CGI) (Guy 1976) a widely used scale which evaluates illness severity on a 1 to 7 point continuum. Severity of illness ratings on the CGI have reported reliability scores ranging from 0.41-0.66 (Guy 1976) Lower scores indicate improved outcomes. Higher scores indicate worse outcomes.
Illness scale: 1 - 7 (1 = Normal/not at all ill ; 7 = Among the most extremely ill patients) Global improvement scale: 1 - 7 (1 = Very much improved ; 7 = Very much worse)"|Baseline-25 weeks|17 participants were administered and completed measurement with the DAI at week 25. Only data for these participants was analyzed for change at week 25.||units on a scale||Standard Deviation|Mean
821226|NCT01152697|Secondary|Change in Serious Mental Illness Severity Score as Measured by the Brief Psychiatric Rating Scale (BPRS) at 25 Weeks|"The BPRS, developed by Overall and Gorham (1962), is a widely used, relatively brief scale that measures major psychotic and non-psychotic symptoms in individuals with SMI. The 18-item BPRS is well-validated and is perhaps the most researched instrument in psychiatry. Reliability coefficients are reported to be in the range of 0.56-0.87.
Scale Range: 18-126 Lower scores represent improved outcomes."|Baseline-25 weeks|19 participants were administered and completed measurement with the BPRS at week 25. Only data for these participants was analyzed for change from baseline to week 25.||units on a scale||Standard Deviation|Mean
821227|NCT01152697|Secondary|Frequency of Health Resource Use Throughout Months 10, 11, and 12|The frequency of health resource use will be measured through interview of the participant.|Month 1-3, Month 10-12|Three participants were administered and completed this measurement at 12 months. Only data for these participants was analyzed for changes.||days||Standard Deviation|Mean
821228|NCT01152697|Primary|Change From Baseline in Adherence Attitude Score as Measured by the Attitude Toward Medication Questionnaire (AMQ) at 25 Weeks|Nineteen item inventory taken by the participant with Scale Range:0-19. Lower scores indicate improved outcomes.|Baseline-25 weeks|19 participants were administered and completed measurement with the AMQ at week 25. Only data for these participants was analyzed for change from baseline to week 25. Lower scores indicate improved outcomes.||units on a scale||Standard Deviation|Mean
821229|NCT01152697|Primary|Change From Baseline in Treatment Adherence Behavior Score as Measured by the Morisky Medication Rating Scale at 25 Weeks|Four item inventory taken by participant with Scale Range: 0-4. Lower scores indicate improved outcomes.|Baseline-25 weeks|16 participants were administered and completed measurement with the Morisky Medication Rating Scale at week 25. Only data for these participants was analyzed for change from baseline to week 25.||units on a scale||Standard Deviation|Mean
821230|NCT01152697|Primary|Change From Baseline in Adherence Attitude Score as Measured by the Drug Attitude Inventory (DAI) at 25 Weeks|Ten item inventory taken by the participant with a Scale Range: 0-10. Higher scores indicate improved outcomes.|Baseline-25 weeks|15 participants were administered and completed measurement with the DAI at week 25. Only data for these participants was analyzed for change from baseline to week 25.||units on a scale||Standard Deviation|Mean
821231|NCT01152697|Primary|Change From Baseline in Treatment Adherence Score as Measured at 25 Weeks|A total treatment adherence score will calculated as a proportion of medications taken as reported from the participant, and evidenced by pill counts and documented medication injections.|Baseline-25 weeks|17 participants were administered and completed measurement of their Treatment Adherence scores at week 25. Only data for these participants was analyzed for change from baseline to week 25.||Percentage of doses||Standard Deviation|Mean
821232|NCT01152697|Primary|Change From Baseline in Days Homeless Out of the Previous 6 Months as Measured at 25 Weeks|Subjects will be asked how many days they have been homeless|Baseline-25 weeks|26 participants were asked how many days they were homeless at week 25. Only data for these participants was analyzed for change from baseline to week 25.||days||Standard Deviation|Mean
821233|NCT01152788|Secondary|Safety and Toxicity Profile (Participants With Grade 3 4 5 Adverse Event)|To determine the safety and toxicity profile of rIL-21 and dacarbazine in patients with chemotherapy and immunotherapy-naive metastatic or recurrent malignant melanoma. Adverse events were measured according to the Common Terminology Criteria version 4.0 for Adverse Events. Number of patients with worst adverse event of grade 3 4 or 5 were counted for both rIL-21 and Dacarbazine arms.|Over study period, up to 22 months|||participants|||Number
821234|NCT01152788|Secondary|Overall Survival|For patients who have died, overall survival is calculated in months from the day of randomization to date of death. Otherwise, survival is censored at the last day the patient is known alive.|From randomization to death of any cause, up to 22 months|||months||95% Confidence Interval|Median
821235|NCT01152788|Secondary|Response Rate|Tumour response is defined per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Complete Response (CR): Disappearance of target and non-target lesions and normalization of tumour markers. Pathological lymph nodes must have short axis measures < 10 mm (Note: continue to record the measurement even if < 10 mm and considered CR). Residual lesions (other than nodes < 10 mm) thought to be non-malignant should be further investigated (by cytology or PET scans) before CR can be accepted. Confirmation of complete response is not required in this randomized study. Partial Response (PR): At least a 30% decrease in the sum of measures (longest diameter for tumour lesions and short axis measure for nodes) of target lesions, taking as reference the baseline sum of diameters. Confirmation of partial response is not required in this randomized study. Overall Response (OR) = CR + PR.|From the start of study treatment until the end of treatment (before disease progression)|||percentage of participants||95% Confidence Interval|Number
821236|NCT01152788|Primary|Progression Free Survival|Progression free survival is defined as the time from randomization to the time of the first documented progression event or death by any cause. A patient who stops treatment with study drug and goes on to receive alternative therapy prior to documentation of disease progression, will be censored at the date alternative therapy began. If a patient has not progressed or received alternative therapy, progression free survival (PFS) will be censored at the date of the last disease assessment.|From randomization to progression or death, up to 22 months|treated population||years||95% Confidence Interval|Median
821273|NCT01153269|Primary|Viral Load|The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 120 are presented.|Week 120|Participants with HIV-1 RNA results at Week 120.||log10 copies/mL||Standard Deviation|Mean
829375|NCT01226706|Secondary|24 Hour Pad Weight (gm) at 3 Months|weight of pad (in gm) worn for 24 hours to detect urine loss|3 months|||gm||Standard Deviation|Mean
821237|NCT01152814|Primary|Percentage of Participants Who Achieved SRH Area ≥25mm2 Against Each of the Three Vaccine Strains After One Vaccination of FLUAD|"Immunogenicity was measured as the percentage of participants achieving SRH area ≥25 mm2 against each of the three vaccine strains at baseline (day 1) and three weeks after FLUAD vaccination (day 22).
This criterion is met according to CHMP guideline if percentage of participants achieving SRH area ≥25 mm2 is 60% (≥65 years)."|day 22|Analysis was done using the PP dataset.||Percentage of participants||95% Confidence Interval|Number
821238|NCT01152814|Primary|Geometric Mean Ratio of Participants Against Each of the Three Vaccine Strains After One Vaccination of FLUAD|"Geometric mean ratio (GMR) of participants was calculated as the ratio of post-vaccination to pre-vaccination SRH geometric mean areas (GMAs), directed against each of the three vaccine strains, three weeks after FLUAD vaccination (day 22).
The CHMP criterion was met if the geometric mean increase (GMR, day 22/day 1) in SRH antibody area is >2.0 (≥65 years)."|day 22|Analysis was done using the PP dataset.||Ratio||95% Confidence Interval|Geometric Mean
821239|NCT01152814|Secondary|Number of Participants Who Reported Solicited Local and Systemic Reactions|Safety was assessed for all participants who reported solicited local and systemic reactions from Day 1 up to and including Day 4 after the FLUAD vaccination in accordance with available safety data on influenza vaccines.|1 to 4 days post-vaccination|Analysis was done using the safety dataset; all participants exposed and who had post-baseline safety data were included in the safety analysis.||Number of participants|||Number
821240|NCT01152814|Primary|Percentage of Participants Who Achieved Seroconversion or Significant Increase in Single Radial Hemolysis (SRH) Area Against Each of Three Vaccine Strains After One Vaccination of FLUAD|"Immunogenicity was measured as the percentage of participants who achieved seroconversion or significant increase in single radial hemolysis (SRH) area, against each of the three vaccine strains, three weeks after vaccination (day 22), evaluated using SRH assay. Seroconversion: proportion of participants with negative pre-vaccination serum and a post-vaccination serum area ≥ 25 mm2. Significant increase: proportion of participants with at least a 50% increase in area from positive pre-vaccination serum. Seroconversion or significant increase: proportion of participants with either seroconversion or significant increase.
The European (Committee for Medicinal Products for Human Use [CHMP]) criterion is met, if percentage of participants achieving seroconversion or significant increase in SRH area is 30% (≥65 years)."|day 22|Per protocol (PP) analysis set included all enrolled participants who had received the vaccine, provided evaluable serum samples before and after vaccination, and had no major protocol violation.||Percentage of participants||95% Confidence Interval|Number
821274|NCT01153269|Primary|Viral Load|The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 108 are presented.|Week 108|Participants with HIV-1 RNA results at Week 108.||log10 copies/mL||Standard Deviation|Mean
821251|NCT01153009|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from mixed model for repeated measurements (MMRM) ANCOVA with treatment, center, week, treatment-by-week interaction, Baseline SDS total score-by-week as fixed effects.|Baseline and Week 8|Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.||scores on a scale||Standard Error|Least Squares Mean
821252|NCT01153009|Secondary|Percentage of Participants in MADRS Remission at Week 8|Remission is defined as a participant with a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≤10. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.|Week 8|Full analysis set, last observation carried forward was used.||percentage of participants|||Number
821253|NCT01153009|Secondary|Change From Baseline in MADRS Total Score at Week 8 in Participants With Baseline Hamilton Anxiety Scale (HAM-A) Total Score ≥20|"The MADRS is a depression rating scale consisting of 10 items, each rated 0 (normal) to 6 (most abnormal). The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. LS means are from a mixed model for repeated measurements (MMRM) ANCOVA with treatment, center, week, treatment-by-week interaction, Baseline MADRS total score-by-week as fixed effects.
HAM-A is a 14 item rating scale to quantify anxiety severity rated on a 5-point scale from 0 (not present) to 4 (severe) with a total score range from 0 to 56, where lower scores indicate mild severity."|Baseline and Week 8|Full analysis set patients with a HAM-A Baseline score ≥20. A mixed model for repeated measurements (MMRM) based on observed cases was used.||scores on a scale||Standard Error|Least Squares Mean
821254|NCT01153009|Secondary|Mean Clinical Global Impression Scale - Improvement (CGI-I) Score at Week 8|The Clinical Global Impression-Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from a mixed model for repeated measurements (MMRM) ANCOVA with treatment, center, week, treatment-by-week interaction, Baseline Clinical Global Impression Scale-Severity of Illness (CGI-S) score-by-week as fixed effects.|Week 8|The Full Analysis Set. A mixed model for repeated measurements (MMRM) based on observed cases was used.||scores on a scale||Standard Error|Least Squares Mean
821255|NCT01153009|Secondary|Percentage of Participants With a MADRS Response at Week 8|Response is defined as a participant with a ≥50% decrease in Montgomery Åsberg Depression Rating Scale (MADRS) total score from Baseline. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.|Baseline and Week 8|Full analysis set, last observation carried forward was used.||percentage of participants|||Number
821275|NCT01153269|Primary|Viral Load|The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 96 are presented.|Week 96|Participants with HIV-1 RNA results at Week 96.||log10 copies/mL||Standard Deviation|Mean
821276|NCT01153269|Primary|Viral Load|The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 84 are presented.|Week 84|Participants with HIV-1 RNA results at Week 84.||log10 copies/mL||Standard Deviation|Mean
821256|NCT01153009|Primary|Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score|The MADRS is a depression rating scale consisting of 10 items, each rated 0 (normal) to 6 (most abnormal). The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. Least squares (LS) means are from a mixed model for repeated measurements (MMRM) analysis of covariance (ANCOVA) with treatment, center, week, treatment-by-week interaction, Baseline MADRS total score-by-week as fixed effects.|Baseline and Week 8|The full analysis set (FAS) included all randomized patients who received at least 1 dose of study drug, and had at least 1 valid post-baseline value for assessment of primary efficacy. A mixed model for repeated measurements (MMRM) based on observed cases was used.||scores on a scale||Standard Error|Least Squares Mean
821257|NCT01153269|Primary|CD4 Cell Count|The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 144 are presented.|Week 144|All participants with CD4+ cell count measurements at Week 144 are included.||CD4+ cells/μL||Standard Deviation|Mean
821258|NCT01153269|Primary|CD4 Cell Count|The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 132 are presented.|Week 132|All participants with CD4+ cell count measurements at Week 132 are included.||CD4+ cells/μL||Standard Deviation|Mean
821259|NCT01153269|Primary|CD4 Cell Count|The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 120 are presented.|Week 120|All participants with CD4+ cell count measurements at Week 120 are included.||CD4+ cells/μL||Standard Deviation|Mean
821260|NCT01153269|Primary|CD4 Cell Count|The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 108 are presented.|Week 108|All participants with CD4+ cell count measurements at Week 108 are included.||CD4+ cells/μL||Standard Deviation|Mean
821261|NCT01153269|Primary|CD4 Cell Count|The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 96 are presented.|Week 96|All participants with CD4+ cell count measurements at Week 96 are included.||CD4+ cells/μL||Standard Deviation|Mean
821262|NCT01153269|Primary|CD4 Cell Count|The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 84 are presented.|Week 84|All participants with CD4+ cell count measurements at Week 84 are included.||CD4+ cells/μL||Standard Deviation|Mean
821263|NCT01153269|Primary|CD4 Cell Count|The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 72 are presented.|Week 72|All participants with CD4+ cell count measurements at Week 72 are included.||CD4+ cells/μL||Standard Deviation|Mean
821264|NCT01153269|Primary|CD4 Cell Count|The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 60 are presented.|Week 60|All participants with CD4+ cell count measurements at Baseline are included.||CD4+ cells/μL||Standard Deviation|Mean
821265|NCT01153269|Primary|CD4 Cell Count|The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 48 are presented.|Week 48|All participants with CD4+ cell count measurements at Week 48 are included.||CD4+ cells/μL||Standard Deviation|Mean
821266|NCT01153269|Primary|CD4 Cell Count|The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 36 are presented.|Week 36|All participants with CD4+ cell count measurements at Week 36 are included.||CD4+ cells/μL||Standard Deviation|Mean
821267|NCT01153269|Primary|CD4 Cell Count|The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 24 are presented.|Week 24|All participants with CD4+ cell count measurements at Week 24 are included.||CD4+ cells/μL||Standard Deviation|Mean
821268|NCT01153269|Primary|CD4 Cell Count|The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 12 are presented.|Week 12|All participants with CD4+ cell count measurements at Week 12 are included.||CD4+ cells/μL||Standard Deviation|Mean
821269|NCT01153269|Primary|CD4 Cell Count|The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 4 are presented.|Week 4|All participants with CD4+ cell count measurements at Week 4 are included.||CD4+ cells/μL||Standard Deviation|Mean
821270|NCT01153269|Primary|CD4 Cell Count|The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Baseline are presented.|Baseline|All participants with CD4+ cell count measurements at Baseline are included.||CD4+ cells/μL||Standard Deviation|Mean
821271|NCT01153269|Primary|Viral Load|The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 144 are presented.|Week 144|Participants with HIV-1 RNA results at Week 144.||log10 copies/mL||Standard Deviation|Mean
821272|NCT01153269|Primary|Viral Load|The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 132 are presented.|Week 132|Participants with HIV-1 RNA results at Week 132.||log10 copies/mL||Standard Deviation|Mean
821277|NCT01153269|Primary|Viral Load|The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 72 are presented.|Week 72|Participants with HIV-1 RNA results at Week 72.||log10 copies/mL||Standard Deviation|Mean
821278|NCT01153269|Primary|Viral Load|The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 60 are presented.|Week 60|Participants with HIV-1 RNA results at Week 60.||log10 copies/mL||Standard Deviation|Mean
821279|NCT01153269|Primary|Viral Load|The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 48 are presented.|Week 48|Participants with HIV-1 RNA results at Week 48.||log10 copies/mL||Standard Deviation|Mean
821280|NCT01153269|Primary|Viral Load|The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 36 are presented.|Week 36|Participants with HIV-1 RNA results at Week 36.||log10 copies/mL||Standard Deviation|Mean
821281|NCT01153269|Primary|Viral Load|The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 24 are presented.|Week 24|Participants with HIV-1 RNA results at Week 24.||log10 copies/mL||Standard Deviation|Mean
821282|NCT01153269|Primary|Viral Load|The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 12 are presented.|Week 12|Participants with HIV-1 RNA results at Week 12.||log10 copies/mL||Standard Deviation|Mean
821283|NCT01153269|Primary|Viral Load|The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 4 are presented.|Week 4|Participants with HIV-1 RNA results at Week 4.||log10 copies/mL||Standard Deviation|Mean
821284|NCT01153269|Primary|Viral Load|The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Baseline are presented.|Baseline|Participants with HIV-1 RNA results at Baseline.||log10 copies/mL||Standard Deviation|Mean
821285|NCT01153269|Primary|Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters|The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 144 are presented.|Week 144|Participants with aspartate aminotransferase and alanine aminotransferase results at Week 144.||U/liter||Standard Deviation|Mean
821286|NCT01153269|Primary|Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters|The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 132 are presented.|Week 132|Participants with aspartate aminotransferase and alanine aminotransferase results at Week 132.||U/liter||Standard Deviation|Mean
821287|NCT01153269|Primary|Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters|The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 120 are presented.|Week 120|Participants with aspartate aminotransferase and alanine aminotransferase results at Week 120.||U/liter||Standard Deviation|Mean
821288|NCT01153269|Primary|Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters|The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 108 are presented.|Week 108|Participants with aspartate aminotransferase and alanine aminotransferase results at Week 108.||U/liter||Standard Deviation|Mean
821289|NCT01153269|Primary|Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters|The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 96 are presented.|Week 96|Participants with aspartate aminotransferase and alanine aminotransferase results at Week 96.||U/liter||Standard Deviation|Mean
821290|NCT01153269|Primary|Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters|The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 84 are presented.|Week 84|Participants with aspartate aminotransferase and alanine aminotransferase results at Week 84.||U/liter||Standard Deviation|Mean
821291|NCT01153269|Primary|Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters|The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 72 are presented.|Week 72|Participants with aspartate aminotransferase and alanine aminotransferase results at Week 72.||U/liter||Standard Deviation|Mean
821292|NCT01153269|Primary|Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters|The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 60 are presented.|Week 60|Participants with aspartate aminotransferase and alanine aminotransferase results at Week 60.||U/liter||Standard Deviation|Mean
821393|NCT01153672|Secondary|Overall Survival|Kaplan-Meier survival curves will be used to describe overall survival. Overall survival time will be censored on the last date the patient was known to be alive.|Time elapsed from the first day of study treatment until death, assessed up to approximately 5 years||||||
821293|NCT01153269|Primary|Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters|The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 48 are presented.|Week 48|Participants with aspartate aminotransferase and alanine aminotransferase results at Week 48.||U/liter||Standard Deviation|Mean
821294|NCT01153269|Primary|Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters|The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 36 are presented.|Week 36|Participants with aspartate aminotransferase and alanine aminotransferase results at Week 36.||U/liter||Standard Deviation|Mean
821295|NCT01153269|Primary|Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters|The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 24 are presented.|Week 24|Participants with aspartate aminotransferase and alanine aminotransferase results at Week 24.||U/liter||Standard Deviation|Mean
821296|NCT01153269|Primary|Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters|The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 12 are presented.|Week 12|Participants with aspartate aminotransferase and alanine aminotransferase results at Week 12.||U/liter||Standard Deviation|Mean
821297|NCT01153269|Primary|Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters|The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 4 are presented.|Week 4|Participants with aspartate aminotransferase and alanine aminotransferase results at Week 4.||U/liter||Standard Deviation|Mean
821298|NCT01153269|Primary|Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters|The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Baseline are presented.|Baseline|Participants with aspartate aminotransferase and alanine aminotransferase results at Baseline.||U/liter||Standard Deviation|Mean
821299|NCT01153321|Secondary|CC16 Concentration in BAL (Post-LPS Challenge)|Post-LPS challenge CC16 concentration in BAL (Day 11). LPS challenge and post-LPS challenge BAL conducted at right middle lobe.|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge||ng/mL||Standard Error|Least Squares Mean
821300|NCT01153321|Secondary|Number of Participants With Treatment-related or Clinically Relevant Changes in Spirometry (Forced Expiratory Volume in 1 Second [FEV1], Forced Vital Capacity [FVC] Pre-bronchodilator)||up to 47 days (visit 1 to visit 6)|||Participants|||Number
821301|NCT01153321|Secondary|Number of Participants With Clinically Relevant Changes in Physical Examination||up to 47 days (visit 1 to visit 6)|||Participants|||Number
821302|NCT01153321|Secondary|Number of Participants With Clinically Relevant Changes in Electrocardiogram (ECG) Variables||up to 47 days (visit 1 to visit 6)|||Participants|||Number
821303|NCT01153321|Secondary|Number of Participants With Clinically Relevant Changes in Vital Signs||up to 47 days (visit 1 to visit 6)|||Participants|||Number
821304|NCT01153321|Secondary|Number of Participants With Clinically Relevant Treatment-related Changes in Laboratory Variables Other Than Monocytes||up to 47 days (visit 1 to visit 6)|||Participants|||Number
821305|NCT01153321|Secondary|Area Under the Plasma Concentration-time Curve From Zero to 8 Hours (AUC(0-8)) of AZD2423 at Steady State|Steady state PK profile measured on Day 10|Day 10 pre-dose, 20 and 40 minutes post-dose, 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose|All 22 patients who received AZD2423 provided at least one plasma sample and were included in the PK analysis although only 21 patients were included in the evaluation of PK at day 10, one patient had been discontinued due to an AE.||nmol*h/L||Full Range|Geometric Mean
821306|NCT01153321|Secondary|Area Under the Plasma Concentration-time Curve From Zero to 24 Hours (AUC(0-24)) of AZD2423 at Steady State|Steady state PK profile measured on Day 10|Day 10 pre-dose, 20 and 40 minutes post-dose, 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose|All 22 patients who received AZD2423 provided at least one plasma sample and were included in the PK analysis although only 21 patients were included in the evaluation of PK at day 10, one patient had been discontinued due to an AE.||nmol*h/L||Full Range|Geometric Mean
821307|NCT01153321|Secondary|Time to Cmax (Tmax) of AZD2423 at Steady State|Steady state PK profile measured on Day 10|Day 10 pre-dose, 20 and 40 minutes post-dose, 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose|All 22 patients who received AZD2423 provided at least one plasma sample and were included in the PK analysis although only 21 patients were included in the evaluation of PK at day 10, one patient had been discontinued due to an AE.||hours||Full Range|Median
821308|NCT01153321|Secondary|Maximum Plasma Concentration (Cmax) of AZD2423 at Steady State|Steady state pharmacokinetic (PK) profile measured on Day 10|Day 10 pre-dose, 20 and 40 minutes post-dose, 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose|All 22 patients who received AZD2423 provided at least one plasma sample and were included in the PK analysis although only 21 patients were included in the evaluation of PK at day 10, one patient had been discontinued due to an AE.||nmol/L||Full Range|Geometric Mean
821309|NCT01153321|Secondary|Neutrophils in Blood (Post-LPS Challenge)|Neutrophils in blood post-LPS challenge (Day 11)|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge||x10^4 cells/mL||Standard Error|Least Squares Mean
821310|NCT01153321|Secondary|Neutrophils in Blood (Pre-LPS Challenge)|Neutrophils in blood pre-LPS challenge (Day 10)|Day 10|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge||x10^4 cells/mL||Standard Error|Least Squares Mean
821311|NCT01153321|Secondary|Monocytes in Blood (Post-LPS Challenge)|Monocytes in blood post-LPS challenge (Day 11)|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge||x10^4 cells/mL||Standard Error|Least Squares Mean
821312|NCT01153321|Secondary|Monocytes in Blood (Pre-LPS Challenge)|Monocytes in blood pre-LPS challenge (Day 10)|Day 10|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge||x10^4 cells/mL||Standard Error|Least Squares Mean
821313|NCT01153321|Secondary|Lymphocytes in Blood (Post-LPS Challenge)|Lymphocytes in blood post-LPS challenge (Day 11)|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge||x10^4 cells/mL||Standard Error|Least Squares Mean
821314|NCT01153321|Secondary|Lymphocytes in Blood (Pre-LPS Challenge)|Lymphocytes in blood pre-LPS challenge (Day 10)|Day 10|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge||x10^4 cells/mL||Standard Error|Least Squares Mean
821315|NCT01153321|Secondary|Eosinophils in Blood (Post-LPS Challenge)|Eosinophils in blood post-LPS challenge (Day 11)|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge||x10^4 cells/mL||Standard Error|Least Squares Mean
821316|NCT01153321|Secondary|Eosinophils in Blood (Pre-LPS Challenge)|Eosinophils in blood pre-LPS challenge (Day 10)|Day 10|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge||x10^4 cells/mL||Standard Error|Least Squares Mean
821317|NCT01153321|Secondary|Basophils in Blood (Post-LPS Challenge)|Basophils in blood post-LPS challenge (Day 11)|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge||x10^4 cells/mL||Standard Error|Least Squares Mean
821318|NCT01153321|Secondary|Basophils in Blood (Pre-LPS Challenge)|Basophils in blood pre-LPS challenge (Day 10)|day 10|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge||x10^4 cells/mL||Standard Error|Least Squares Mean
821319|NCT01153321|Secondary|CC16 Concentration in Blood (Post-LPS Challenge)|CC16 concentration in blood post-LPS challenge (Day 11)|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. Five patients had missing observations.||ng/mL||Standard Error|Least Squares Mean
821320|NCT01153321|Secondary|CC16 Concentration in Blood (Pre-LPS Challenge)|CC16 concentration in blood pre-LPS challenge (Day 10)|Day 10|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. Three patients had missing observations.||ng/mL||Standard Error|Least Squares Mean
821321|NCT01153321|Secondary|SP-D Concentration in Blood (Post-LPS Challenge)|SP-D concentration in blood post-LPS challenge (Day 11)|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge||ng/mL||Standard Error|Least Squares Mean
821322|NCT01153321|Secondary|SP-D Concentration in Blood (Pre-LPS Challenge)|SP-D concentration in blood pre-LPS challenge (Day 10)|Day 10|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge||ng/mL||Standard Error|Least Squares Mean
821323|NCT01153321|Secondary|TNF-α Concentration in Blood (Post-LPS Challenge)|TNF-α concentration in blood post-LPS challenge (Day 11)|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge||pg/mL||Standard Error|Least Squares Mean
821324|NCT01153321|Secondary|TNF-α Concentration in Blood (Pre-LPS Challenge)|TNF-α concentration in blood pre-LPS challenge (Day 10)|Day 10|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge||pg/mL||Standard Error|Least Squares Mean
821325|NCT01153321|Secondary|IL-8 Concentration in Blood (Post-LPS Challenge)|IL-8 concentration in blood post-LPS challenge (Day 11)|day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge||pg/mL||Standard Error|Least Squares Mean
821326|NCT01153321|Secondary|IL-8 Concentration in Blood (Pre-LPS Challenge)|IL-8 concentration in blood pre-LPS challenge (Day 10)|Day 10|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge||pg/mL||Standard Error|Least Squares Mean
821327|NCT01153321|Secondary|IL-6 Concentration in Blood (Post-LPS Challenge)|IL-6 concentration in blood post-LPS challenge (Day 11)|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge||pg/mL||Standard Error|Least Squares Mean
822025|NCT01152437|Secondary|Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 8 (Cpre,ss,8)|Cpre,ss,8 represents the pre-dose concentration of afatinib in plasma at steady state on day 8.|day 8|Randomised set for wild-type group and treated set for mutated group.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
821328|NCT01153321|Secondary|IL-6 Concentration in Blood (Pre-LPS Challenge)|IL-6 concentration in blood pre-LPS challenge (Day 10)|Day 10|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge||pg/mL||Standard Error|Least Squares Mean
821329|NCT01153321|Secondary|IL-1β Concentration in Blood (Post-LPS Challenge)|IL-1β concentration in blood post-LPS challenge (Day 11)|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge||pg/mL||Standard Error|Least Squares Mean
821330|NCT01153321|Secondary|IL-1β Concentration in Blood (Pre-LPS Challenge)|IL-1β concentration in blood pre-LPS challenge (Day 10)|Day 10|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge||pg/mL||Standard Error|Least Squares Mean
821331|NCT01153321|Secondary|CCL2 Concentration in Blood (Post-LPS Challenge)|CCL2 concentration in blood post-LPS challenge (Day 11).|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge||pg/mL||Standard Error|Least Squares Mean
821332|NCT01153321|Secondary|CCL2 Concentration in Blood (Pre-LPS Challenge)|CCL2 concentration in blood pre-LPS challenge (Day 10)|Day 10|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge||pg/mL||Standard Error|Least Squares Mean
821333|NCT01153321|Secondary|SAA Concentration in Blood (Post-LPS Challenge)|SAA concentration in blood post-LPS challenge (Day 11)|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge||ng/mL||Standard Error|Least Squares Mean
821334|NCT01153321|Secondary|SAA Concentration in Blood (Pre-LPS Challenge)|SAA concentration in blood pre-LPS challenge (Day 10).|Day 10|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge||ng/mL||Standard Error|Least Squares Mean
821335|NCT01153321|Secondary|SP-D Concentration in BAL (Post-LPS Challenge)|Post-LPS challenge SP-D concentration in BAL (Day 11). LPS challenge and post-LPS challenge BAL conducted at right middle lobe.|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. One patient had missing observations.||ng/mL||Standard Error|Least Squares Mean
821336|NCT01153321|Secondary|RANTES Concentration in BAL (Post-LPS Challenge)|Post-LPS challenge RANTES concentration in BAL (Day 11). LPS challenge and post-LPS challenge BAL conducted at right middle lobe.|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. One patient had missing observations.||pg/mL||Standard Error|Least Squares Mean
821337|NCT01153321|Secondary|IL-8 Concentration in BAL (Post-LPS Challenge)|Post-LPS challenge IL 8 concentration in BAL. LPS challenge and post-LPS challenge BAL conducted at right middle lobe.|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. One patient had missing observations.||pg/mL||Standard Error|Least Squares Mean
821338|NCT01153321|Secondary|IL-6 Concentration in BAL (Post-LPS Challenge)|Post-LPS challenge IL-6 concentration in BAL (Day 11). LPS challenge and post-LPS challenge BAL conducted at right middle lobe.|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. One patient had missing observations.||pg/mL||Standard Error|Least Squares Mean
821339|NCT01153321|Secondary|IL-1β Concentration in BAL (Post-LPS Challenge)|Post-LPS challenge IL-1β concentration in BAL (Day 11). LPS challenge and post-LPS challenge BAL conducted at right middle lobe.|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. One patient had missing observations.||pg/mL||Standard Error|Least Squares Mean
821340|NCT01153321|Secondary|CCL2 Concentration in BAL (Post-LPS Challenge)|Post-LPS challenge CCL2 concentration in BAL (Day 11). LPS challenge and post-LPS challenge BAL conducted at right middle lobe.|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. One patient had missing observations.||pg/mL||Standard Error|Least Squares Mean
821341|NCT01153321|Secondary|TNF α Concentration in BAL (Post-LPS Challenge)|Post-LPS challenge TNF α concentration in BAL (Day 11). LPS challenge and post-LPS challenge BAL conducted at right middle lobe.|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. One patient had missing observations.||pg/mL||Standard Error|Least Squares Mean
821342|NCT01153321|Secondary|Macrophages in BAL (Post-LPS Challenge)|Post-LPS challenge macrophage differential in BAL. LPS challenge and post-challenge BAL conducted at right middle lobe.|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge||x10^4 cells/mL||Standard Deviation|Least Squares Mean
821421|NCT01153711|Secondary|Fraction of Urine Excretion From 0 to 24 Hours at Steady State (fe0-24,ss)|fe0-24,ss represents the fraction of olodaterol eliminated in urine from time point 0 to 24 hours after administration at steady state.|Day 8 of period 1 and day 14 of period 2|PK analysis set with evaluable data for this endpoint.||Percentage||Geometric Coefficient of Variation|Geometric Mean
821343|NCT01153321|Secondary|Neutrophils in BAL (Post-LPS Challenge)|Post-LPS challenge neutrophil differential in BAL. LPS challenge and post-challenge BAL conducted at right middle lobe.|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge||x10^4 cells/mL||Standard Error|Least Squares Mean
821344|NCT01153321|Secondary|Lymphocytes in BAL (Post-LPS Challenge)|Post-LPS challenge lymphocyte differential in BAL. LPS challenge and post-challenge BAL conducted at right middle lobe.|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge||x10^4 cells/mL||Standard Error|Least Squares Mean
821345|NCT01153321|Secondary|Eosinophils in BAL (Post-LPS Challenge)|Post-LPS challenge eosinophil differential in BAL. LPS challenge and post-challenge BAL conducted at right middle lobe.|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. Five patients had missing observations.||x10^4 cells/mL||Standard Error|Least Squares Mean
821346|NCT01153321|Secondary|Biopsy Epithelium Grade (Post-LPS Challenge)|Biopsies (from right middle lobe) were assessed for routine histopathology. Epithelial morphology was graded on subjective scale from 1 to 5. 1=normal; 2=PAS positive cell hypertrophy; 3=PAS positive cell hyperplasia; 4=Metaplasia with PAS positive cells throughout mucosa; 5=Metaplasia and/or squamous plates with loss of PAS positive cells|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. Thirteen patients had missing observations.||Units on a scale||Standard Error|Least Squares Mean
821347|NCT01153321|Secondary|Biopsy PAS Reaction Grade (Post-LPS Challenge)|Biopsies stained using PAS method. Graded on subjective scale (1=normal; 2=PAS positive cell hypertrophy; 3=PAS positive cell hyperplasia; 4=Metaplasia with PAS positive cells throughout mucosa; 5=Metaplasia and/or squamous plates with loss of PAS positive cells).|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. Thirteen patients had missing observations.||Units on a scale||Standard Error|Least Squares Mean
821348|NCT01153321|Secondary|CD3+ in Biopsy Sample (Post-LPS Challenge)|Post-LPS challenge data (Day 11). Post-LPS challenge biopsies taken from right middle lobe. Cells counted in subepithelium.|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. Six patients had missing observations.||cells/mm^2||Standard Error|Least Squares Mean
821349|NCT01153321|Secondary|CD45+ in Biopsy Sample (Post-LPS Challenge)|Post-LPS challenge data (Day 11). Post-LPS challenge biopsies taken from right middle lobe. Cells counted in subepithelium.|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. Six patients had missing observations.||cells/mm^2||Standard Error|Least Squares Mean
821350|NCT01153321|Secondary|Total Macrophages in Biopsy Sample (Post-LPS Challenge)|Post-LPS challenge data (Day 11). Post-LPS challenge biopsies taken from right middle lobe. Cells counted in subepithelium.|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. Six patients had missing observations.||cells/mm^2||Standard Error|Least Squares Mean
821351|NCT01153321|Secondary|Total Neutrophils in Biopsy Sample (Post-LPS Challenge)|Pre-challenge = Day 11. Biopsies taken from left lingula. Cells counted in subepithelium.|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. Six patients had missing observations.||cells/mm^2||Standard Error|Least Squares Mean
821352|NCT01153321|Primary|Absolute Monocyte Count in BAL Post-LPS Challenge|Monocyte count in BAL post-LPS challenge (Day 11)|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge||x10^4 cells/mL||Standard Error|Least Squares Mean
821353|NCT01153347|Secondary|Change in Irritability Symptoms as Measured by the Sheehan Irritability Scale (SIS) Total Score From Randomization (Week 8) to End of Treatment (Week 16)|A self-administered scale to be used by clinical subjects to rate suffering over the past week with regard to irritability symptoms. The total SIS score is the sum of 7 items, and ranges from 0 to 70. Each item is assessed on an 11- point scale where 0=not at all, 1-3=mildly, 4-6=moderately, 7-9=markedly, and 10=extremely. The SIS also records the number of days impaired by irritability.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
821354|NCT01153347|Secondary|Change in EuroQol - 5 Dimensions (EQ-5D) From Randomization (Week 8) to End of Treatment (Week 16)|A self-assessment questionnaire that provides 2 measures of health status. The EQ-5D index score is a weighted linear combination over 5 dimensions of health status. The score for each of the 5 dimensions can range from 1 to 3, and an equation is used to calculate the EQ-5D index score. The EQ-5D index score can range from possible negative values (minimum -0.415) to a maximum of 1.0. The EQ-VAS is a visual analog scale with a range of 0 to 100. For both variables, a higher score indicates a better health state.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
822221|NCT01161446|Secondary|Bacterial Sexually Transmitted Infections|Includes syphilis, gonorrhea, and chlamydial infection|Assessed at 15 months|Includes only participants who received screening for sexually transmitted infections at the end-of-study visit.||Participants|||Count of Participants
821355|NCT01153347|Secondary|Change From Randomization (Week 8) to End of Treatment (Week 16) in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q LES-Q-SF) Item 16|The Q-LES-Q-SF (Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form) measures the patient’s satisfaction with medication and overall quality of life. The 16th item is a global rating of overall life satisfaction and contentment, rated on a 1 to 5 scale. Higher scores are indicative of greater satisfaction.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
821356|NCT01153347|Secondary|Change From Randomization (Week 8) to End of Treatment (Week 16) in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form(Q LES-Q-SF)Item 15|The Q-LES-Q-SF (Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form) measures the patient’s satisfaction with medication and overall quality of life. The 15th item queries respondents’ satisfaction with the medication they are taking, rated on a 1 to 4 scale, score 0 indicates that no medication was taken. Higher scores are indicative of greater satisfaction.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
821357|NCT01153347|Secondary|Change in Overall Quality of Life and Satisfaction From Randomization (Week 8) to End of Treatment (Week 16) by Assessing the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) % Maximum Total Score|The Q-LES-Q-SF total score is derived by summing item scores 1 to 14. Higher scores are indicative of greater enjoyment or satisfaction in each domain. The Q-LES-Q-SF % maximum total score is calculated as 100% × (Q-LES-Q-SF total score – 14) / 56, and can range from 0% to 100%.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
821358|NCT01153347|Secondary|Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Family Life/Home Responsibilities Domain Score|A 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The 3 inter-correlated domains are school/work, social life, and family life/home responsibilities. The numerical rating for the SDS family life/home responsibilities domain score is 0- 10, where 10 is considered to be 'highly impaired'.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
821359|NCT01153347|Secondary|Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Social Life Domain Score|A 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The 3 inter-correlated domains are school/work, social life, and family life/home responsibilities. The numerical rating for the SDS social life domain score is 0- 10, where 10 is considered to be 'highly impaired'.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
821360|NCT01153347|Secondary|Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Work/School Domain Score|A 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The 3 inter-correlated domains are school/work, social life, and family life/home responsibilities. The numerical rating for the work/school domain score is 0- 10, where 10 is considered to be 'highly impaired'.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
821361|NCT01153347|Secondary|Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by the Sheehan Disability Scale (SDS) Total Score|Sheehan Disability Scale (SDS) is 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The SDS total score is calculated as the sum of the score for the 3 inter-correlated domains (school/work, social life, and family life/home responsibilities) and ranges from 0 (unimpaired) to 30 (highly impaired).|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
821362|NCT01153347|Secondary|Change in MADRS Total Score From Randomization (Week 8) to Week 14|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to Week 14|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
821363|NCT01153347|Secondary|Change in MADRS Total Score From Randomization (Week 8) to Week 12|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to Week 12|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
821364|NCT01153347|Secondary|Change in MADRS Total Score From Randomization (Week 8) to Week 10|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to Week 10|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
821365|NCT01153347|Secondary|Change in MADRS Total Score From Randomization (Week 8) to Week 9|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to Week 9|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
821366|NCT01153347|Secondary|Change in Hamilton Anxiety Scale (HAM-A) Total Score From Randomization (Week 8) to End of Treatment (Week 16)|A 14-item clinician-administered scale for the evaluation of anxiety symptoms. Each HAM-A item is rated on a 0 to 4 scale, the total score can range from 0 to 56. Higher HAM-A scores indicate higher levels of anxiety.|Randomization (Week 8) to end of treatment (Week 16)|||units on a scale||Standard Error|Least Squares Mean
821367|NCT01153347|Secondary|Response in the Clinical Global Impression-Improvement (CGI-I) Defined as CGI-I Rating of “Very Much Improved” or “Much Improved” From Randomization (Week 8) to End of Treatment (Week 16)|A 3-part, clinician-administered scale that rates the improvement or worsening of the patient’s illness from randomization (baseline). Each item is scored on a 1 to 7 scale. CGI-I scores >4 indicate worsening, while scores <4 indicate improvement.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||percentage of participants analyzed|||Number
821368|NCT01153347|Secondary|Change in the Clinician-rated Global Outcome of Severity as Measured by the Clinical Global Impression-Severity (CGI-S) Score From Randomization (Week 8) to End of Treatment (Week 16)|A 3-part, clinician-administered scale that rates the improvement or worsening of the patient’s illness from randomization (baseline). Each item is scored on a 1 to 7 scale. Higher CGI-S scores indicate greater illness severity.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
821369|NCT01153347|Secondary|Change in Depressive Symptoms From Randomization (Week 8) to End of Treatment (Week 16) as Measured by Hamilton Rating Scale for Depression-17 Items (HAMD-17) Total Score|A 17-item, clinician-rated scale that assesses depressive symptoms. The HAMD-17 consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The HAMD-17 total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher HAMD-17 scores indicate more severe depression.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
821370|NCT01153347|Secondary|Sustained Remission, Defined as a MADRS Total Score of ≤8 at Week 12, Week 14, and End of Treatment (Week 16)|"The percentage of patients with a MADRS total score of ≤8 at Week 12, Week 14, and end of treatment (Week 16)was calculated.
A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Week 12, Week 14, Week 16|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||percentage of participants analyzed|||Number
821371|NCT01153347|Secondary|Sustained Response, Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score and a MADRS Total Score of ≤12 at Week 12, Week 14, and End of Treatment (Week 16)|"The percentage of patients with a ≥50% reduction from randomization (Week 8) in MADRS total score and a MADRS total score of ≤12 at Week 12, Week 14, and end of treatment (Week 16) was calculated.
A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Randomization (Week 8) to end of treatment (Week 16); Week 12, Week 14, and Week 16|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||percentage of patients analyzed|||Number
821372|NCT01153347|Secondary|Early and Sustained Response, Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score and a MADRS Total Score of ≤12 at Week 10, Week 12, Week 14, and End of Treatment (Week 16)|"The percentage of patients with a ≥50% reduction from randomization (Week 8) in MADRS total score and a MADRS total score of ≤12 at Week 10, Week 12, Week 14, and end of treatment (Week 16) was calculated.
A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Randomization (Week 8) to end of treatment (Week 16); Week 10, Week 12, Week 14, and Week 16|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||percentage of participants analyzed|||Number
821422|NCT01153711|Secondary|Time From Dosing to the Maximum Concentration at Steady State (Tmax,ss)|tmax,ss represents the time from dosing to maximum concentration of olodaterol and olodaterol glucuronide in plasma at steady state.|Day 8 of period 1 and day 14 of period 2|PK analysis set with evaluable data for this endpoint.||Hours||Full Range|Median
821373|NCT01153347|Secondary|Remission in Depressive Symptoms of MDD, Defined as MADRS Total Score of ≤8 at End of Treatment (Week 16)|"The percentage of patients with a MADRS total score of ≤8 at end of treatment (Week 16) was calculated.
A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Week 16|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||percentage of participants analyzed|||Number
821374|NCT01153347|Secondary|Response in Depressive Symptoms of Major Depressive Disorder (MDD), Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score at End of Treatment (Week 16)|"The percentage of patients with a ≥50% reduction from randomization (Week 8) in MADRS total score at end of treatment (Week 16) was calculated.
A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||percentage of participants analyzed|||Number
821375|NCT01153347|Primary|Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Randomization to End of Treatment.|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
821376|NCT01153425|Secondary|Percentage of Change in Bone Volume Fraction (BVF)|Average fractional content of bone expressed in percent|Change between baseline and 12 months|||Percentage of Change||Standard Deviation|Mean
821377|NCT01153425|Primary|Percentage of Change in Trabecular Surface-to-curve Ratio|Ratio of the volume densities of surface (S) and curve (C)-type voxels, S/C|Change between baseline and 12 months|Mean change in structural and mechanical markers of bone turnover between the two groups.||Percentage of Change||Standard Deviation|Mean
821378|NCT01153503|Primary|Morphine Consumption|Morphine consumption over the first 24 hours|24 hours post surgery|||mg||Standard Deviation|Mean
821379|NCT01153581|Primary|Skin Microvascular Responses|"Changes in blood flow in the small vessel in the skin are measured in response to sequential heat and drug stimulation. It is measured in volts, and then corrected for a maximum level and expressed as “% max. This is measured with a Laser Doppler probes, which measures volts."|2 months|Women with and without orthostatic intolerance||Percent of max volts||Standard Error|Mean
821380|NCT01153581|Primary|Baroreceptor Function|"This is a measure of how the body responds to changes in pressure induced by changes in position such as sitting, lying standing. The pressure changes are induced by gravity. The measurement described below to assess baroreceptor function is units of change in forearm vascular resistance for a given change in lower body negative pressure. This allows us to determine how good the body is at sending signals to the periphery to respond to postural changes.
Baroreflex sensitivity is defined as the change in interbeat interval (IBI) in milliseconds per unit change in BP. For example, when the BP rises by 10 mmHg and IBI increases by 100 ms, BRS would be 100/10 = 10 ms/mmHg."|2 months|Women with low and high orthostatic tolerance||ms/mm Hg||Standard Error|Mean
821381|NCT01153581|Primary|Orthostatic Tolerance|We used a measure called cumulative stress index to determine orthostatic tolerance, which is the amount of time at a level of negative pressure each subject can maintain before feeling as if she is going to pass out. This is calculated by multiplying the pressure in mm Hg by the time in min.|2 months|||mmHg*min||Standard Deviation|Mean
821382|NCT01153620|Secondary|Comparison of the Percentage of Patients With Target Wounds <50 CFU|Comparison of the percentage of patients with target wounds <50 CFU after 60 minutes of treatment application|60 minutes||||||
821383|NCT01153620|Secondary|Reduction in CFU|Comparison of the percentage reduction in CFU after 15, 30 and 60 minutes of treatment application|15 minutes, 30 minutes and 60 minutes||||||
821384|NCT01153620|Secondary|Local Tolerability: Pruritis Burning|Local tolerability after 60 minutes of treatment application.|60 minutes||||||
821385|NCT01153620|Primary|Reduction (log10) in Colony Forming Units|Comparison of the log10 reduction in CFU after 60 minutes of treatment application.|60 minutes|ITT population: comprising all wounds having received the study treatment for any duration (n=61).||log 10 Colony Forming Units|Participants|Standard Deviation|Mean
821386|NCT01153633|Primary|Absolute Change of Target Ulcer From Baseline to Last Visit||12 weeks|per protocol analysis||square centimeters||Standard Error|Least Squares Mean
821387|NCT01153633|Primary|Healing of Target Ulcer atV6/EOS|Number of ulcers healed at V6/EOS|12 weeks|per protocol analysis||ulcers|||Number
821388|NCT01153633|Secondary|Condition of Wound Bed|Sum of granulation and epithelium (% of wound bed), absolute change from baseline to V6/EoS|12 Weeks|per protocol analysis||percentage of of wound bed||Standard Deviation|Mean
821389|NCT01153633|Secondary|Pain|Absolute change (mm VAS) from baseline to V6/EoS. Pain intensity assessed by patient. At each study visit the patients assessed their pain intensity using a 100 mm Visual Analogue Scale (VAS). Thereby 0 mm represented ‘no pain’ and 100 mm ‘worst possible pain’.|12 Weeks|per protocol analysis||mm||Standard Deviation|Mean
821390|NCT01153633|Secondary|Number of Different Microganisms at V6/EoS||12 Weeks|per protocol analysis||Number of microgasism species||Standard Deviation|Mean
821391|NCT01153633|Primary|Percent Change of Wound Size From Baseline to Last Visit||12 Weeks|Per protocol set||percentage change in wound size (cm2)||Standard Error|Least Squares Mean
821392|NCT01153672|Secondary|Percentage of Patients That Experience Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0||Up to approximately 5 years|||percentage of participants|||Number
829410|NCT01226719|Secondary|Overall Survival (OS)|The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death|18 months|All patients on study||months||95% Confidence Interval|Median
821394|NCT01153672|Secondary|Progression-free Survival|Kaplan-Meier survival curves will be used to describe progression-free survival. For progression-free survival, patients without documented disease progression or death will be treated as censored observations on the date of the last tumor assessment.|Time elapsed from the first day of study treatment, until disease progression or death, assessed up to approximately 5 years||||||
821395|NCT01153672|Primary|Duration of Response|Duration of response will be summarized for responders.|Up to approximately 5 years|||weeks||Full Range|Median
821396|NCT01153672|Primary|Rate of Clinical Benefit According to RECIST|"A 90% score (Wilson) confidence interval will be computed for the response rate and the rate of clinical benefit. The radiological (by computed tomography [CT]) response rate of vorinostat will be determined by tumor measurements assessed by modified RECIST criteria.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) assessed by CT, Clinical Benefit was defined as an objective response (complete response [CR], partial response [PR]) or stable disease [SD]). CR=the disappearance of all target lesions; PR=at least a 30% decrease in the sum of the longest diameter (LD) of target lesions; SD=neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started; PD=at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum of the LD recorded since the treatment started or the appearance of 1 or more new lesions."|Up to approximately 5 years|||percentage of evaluable participants||90% Confidence Interval|Number
821397|NCT01153685|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the entire study period|The analysis was performed on the Total Vaccinated Cohort.||Subjects|||Number
821398|NCT01153685|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs).|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within the 21-day post-vaccination period|The analysis was performed on the Total Vaccinated cohort.||Subjects|||Number
821399|NCT01153685|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|"Unsolicited adverse events (AE) covers any AE reported in addition to those solicited during the clinical study and any solicited symptoms with onset outside the specified period of follow-up for solicited symptoms.
Any = occurrence of any adverse event regardless of intensity grade or relationship to vaccination.
Grade 3 = an unsolicited AE that prevented normal everyday activity. Related = event assessed by the investigator as causally related to the vaccination."|Within the 21-day post-vaccination period|The analysis was performed on the Tota Vaccinated Cohort.||Subjects|||Number
821400|NCT01153685|Secondary|Number of Subjects With Solicited Local and General Symptoms After Administration of Fluviral.|Solicited local symptoms assessed were pain, redness and swelling at the injection site. Solicited general symptoms assessed were bronchospasm, chills, cough, fatigue, headache, joint pain at other location, muscle aches, red eyes, sore throat, swelling of the face and temperature (defined as orally temperature equal or above 38.0 degrees Celcius)|During a 4-days (Day 0-3) follow-up period after vaccination.|The analysis was performed on the Total Vaccinated Cohort on subjects with available results.||Subjects|||Number
821401|NCT01153685|Primary|Seroconversion Factor for Antibodies Against Fluviral Vaccine Strains.|Seroconversion Factor (SCF) is defined as the fold increase in serum HI antibody GMTs post-vaccination (Day 21) compared to prevaccination (Day 0).|At Day 21 after vaccination|The analyses were based on the According-To-Protocol (ATP) cohort for immunogenicity.||Fold increase||95% Confidence Interval|Mean
821402|NCT01153685|Primary|Number of Seroconverted Subjects for Antibodies Against Fluviral Vaccine Strains.|A subject seroconverted for haemagglutination inhibition (HI) antibodies was defined as a subject with either a prevaccination (Day 0) HI antibody titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a prevaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer.|At Day 21 after vaccination|The analyses were based on the According-To-Protocol (ATP) cohort for immunogenicity.||Subjects|||Number
821403|NCT01153685|Primary|Number of Seroprotected Subjects for Antibodies Against Fluviral Vaccine Strains.|A Seroprotected subject was defined as a subject with a serum haemagglutination inhibition (HI) antibody titer greater than or equal to 1:40.|At Day 21 after vaccination|The analyses were based on the According-To-Protocol (ATP) cohort for immunogenicity.||Subjects|||Number
821404|NCT01153685|Primary|Number of Seroprotected Subjects for Antibodies Against Fluviral Vaccine Strains.|A Seroprotected subject was defined as a subject with a serum haemagglutination inhibition (HI) antibody titer greater than or equal to 1:40.|At Day 0 before vaccination|The analyses were based on the According-To-Protocol (ATP) cohort for immunogenicity.||Subjects|||Number
821405|NCT01153685|Primary|Geometric Mean Titers (GMTs) of Haemagglutination Inhibition (HI) Antibodies Against Fluviral Vaccine Strains.|The Fluviral vaccine strains were A/California (H1N1), A/Victoria (H3N2) and B/Brisbane|At Day 21 after vaccination|The analyses were based on the According-To-Protocol (ATP) cohort for immunogenicity.||Titer||95% Confidence Interval|Geometric Mean
821406|NCT01153685|Primary|Geometric Mean Titers (GMTs) of Haemagglutination Inhibition (HI) Antibodies Against Fluviral Vaccine Strains.|The Fluviral vaccine strains were A/California (H1N1), A/Victoria (H3N2) and B/Brisbane|At Day 0 before vaccination|The analyses were based on the According-To-Protocol (ATP) cohort for immunogenicity.||Titer||95% Confidence Interval|Geometric Mean
821407|NCT01153698|Secondary|Percentage of Patients With Single Components of Composite of sVTE and All-cause Mortality Events During Total Treatment Period|Total treatment period is defined from first enoxaparin administration to 24h after last Pradaxa intake or to 35h after last enoxaparin administration if no switch was performed.|From first enoxaparin administration until 24 hours after last Pradaxa intake ( planned: knee replacement: Day 10 after surgery, hip replacement:Day 28-35 after surgery)|Treated Set||Number of participants|||Number
821408|NCT01153698|Secondary|Volume of Wound Drainage (Post-operative)|Total volume of wound drainage is calculated as sum of volume drainage from end of surgery until first dose of Pradaxa plus volume drainage from first dose of Pradaxa and onwards.|From end of surgery (before first dosing) until 24 hours after last Pradaxa intake|Treated Set (All patients with non-missing information for both, the volume drainage until first dose of Pradaxa and the volume drainage from first dose of Pradaxa and onwards).||ml||Standard Deviation|Mean
821409|NCT01153698|Secondary|Percentage of Patients With Major Extra-surgical Site Bleedings During Total Treatment Period|Major extra-surgical site bleedings include all major bleedings not occurred at surgical site|From first enoxaparin administration until 24 hours after last Pradaxa intake if switch to Pradaxa was performed or to 35 hours after last enoxaparin administration if no switch was performed|TS||Percentage of participants||95% Confidence Interval|Number
821410|NCT01153698|Secondary|Percentage of Patients With sVTE and All-cause Mortality Events During Switch Treatment Period|"sVTE was defined as the composite of documented symptomatic proximal and distal DVT and documented symptomatic non-fatal PE.
Symptomatic DVT is defined as clinically symptomatic venous thromboembolic event and symptomatic non-fatal PE is defined as symptomatic pulmonary embolism"|From last enoxaparin administration until first Pradaxa intake|TS reduced to patients with switch period.||Percentage of participants||95% Confidence Interval|Number
821411|NCT01153698|Secondary|Percentage of Patients With sVTE and All-cause Mortality Events During Pre-switch Treatment Period|sVTE was defined as the composite of documented symptomatic proximal and distal DVT and documented symptomatic non-fatal PE.|From first enoxaparin administration until last enoxaparin administration|TS reduced to patients with pre-switch period.||Percentage of participants||95% Confidence Interval|Number
821412|NCT01153698|Secondary|Percentage of Patients With sVTE and All-cause Mortality Events During Total Treatment Period|sVTE was defined as the composite of documented symptomatic proximal and distal DVT and documented symptomatic non-fatal PE.|From first enoxaparin administration until 24 hours after last Pradaxa intake if switch to Pradaxa was performed or to 35 hours after last enoxaparin administration if no switch was performed|TS||Percentage of participants||95% Confidence Interval|Number
821413|NCT01153698|Secondary|Percentage of Patients With MBE During Pre-switch Treatment Period|MBEs were defined according to the modified McMaster criteria. The criteria for MBEs were: fatal; clinically overt associated with loss of haemoglobin >=20g/L in excess of what was expected; clinically overt leading to the transfusion of >=2 units packed cells or whole blood in excess of what was expected; symptomatic retroperitoneal, intracranial, intraocular or intraspinal; requiring treatment cessation; leading to re-operation.|From first enoxaparin administration until last enoxaparin administration|TS reduced to patients with pre-switch period.||Percentage of participants||95% Confidence Interval|Number
821414|NCT01153698|Secondary|Percentage of Patients With MBE During Total Treatment Period|MBEs were defined according to the modified McMaster criteria. The criteria for MBEs were: fatal; clinically overt associated with loss of haemoglobin >=20g/L in excess of what was expected; clinically overt leading to the transfusion of >=2 units packed cells or whole blood in excess of what was expected; symptomatic retroperitoneal, intracranial, intraocular or intraspinal; requiring treatment cessation; leading to re-operation.|From first enoxaparin administration until 24 hours after last Pradaxa intake if switch to Pradaxa was performed or to 35 hours after last enoxaparin administration if no switch was performed|TS||Percentage of participants||95% Confidence Interval|Number
821415|NCT01153698|Primary|Percentage of Patients With Symptomatic Venous Thromboembolic Events (sVTE) and All-cause Mortality Events During the Switch-/ Post-switch Treatment Period|sVTE was defined as the composite of documented symptomatic proximal and distal deep vein thrombosis (DVT) and documented symptomatic non-fatal pulmonary embolism (PE).|From last enoxaparin administration until 24 hours after last Pradaxa intake (planned: knee replacement: Day 10 after surgery, hip replacement:Day 28-35 after surgery)|TS reduced to patients with switch-/ post-switch period.||Percentage of participants||95% Confidence Interval|Number
821416|NCT01153698|Primary|Percentage of Patients With Major Bleeding Events (MBE) During the Switch-/ Post-switch Treatment Period|Major bleeding events were defined according to the modified McMaster criteria. The criteria for MBEs were: fatal; clinically overt associated with loss of haemoglobin >=20g/L in excess of what was expected; clinically overt leading to the transfusion of >=2 units packed cells or whole blood in excess of what was expected; symptomatic retroperitoneal, intracranial, intraocular or intraspinal; requiring treatment cessation; leading to re-operation.|From last enoxaparin administration until 24 hours after last Pradaxa intake( planned: knee replacement: Day 10 after surgery, hip replacement:Day 28-35 after surgery)|Treated set (TS) reduced to patients with switch-/ post-switch period. TS includes all patients who received at least one dose of enoxaparin or at least one dose of Pradaxa.||Percentage of participants||95% Confidence Interval|Number
821417|NCT01153711|Secondary|Assessment of Tolerability by the Investigator|The investigator assessed tolerability based on adverse events and the laboratory evaluation at the end-of-trial examination. The investigator classified the overall tolerability according to the categories 'good', 'satisfactory', 'not satisfactory', and 'bad'.|End of period 1 and end of period 2|TS||participants|||Number
821418|NCT01153711|Secondary|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG|Clinical relevant abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as treatment-induced Adverse Events.|First administration of trial medication until 6 days after last administration of trial medication|Treated set (TS) - Treated set includes all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.||participants|||Number
821419|NCT01153711|Secondary|Area Under Curve From 0 to 8 Hours at Steady State (AUC0-8,ss)|AUC0-8,ss represents the area under the concentration curve of olodaterol glucuronide in plasma from 0 to time t=8 at steady state, where t is defined as the latest time-point where at least 2/3 of the subjects in both treatment periods reveal quantifiable plasma concentrations of the analyte. The geometric mean is actually the adjusted geometric mean. The geometric coefficient of variation (gCV) is the intra-individual gCV.|Day 8 of period 1 and day 14 of period 2|PK analysis set with evaluable data for this endpoint.||Picogram*hours/milliliter||Geometric Coefficient of Variation|Geometric Mean
821420|NCT01153711|Secondary|Amount of the Analyte Excreted in Urine From 0 to 24 Hours at Steady State (Ae0-24,ss)|Ae0-24,ss represents the amount of olodaterol and olodaterol glucuronide that is eliminated in urine from the time 0 to 24h after administration at steady state. The geometric mean is actually the adjusted geometric mean. The geometric coefficient of variation (gCV) is the intra-individual gCV.|Day 8 of period 1 and day 14 of period 2|PK analysis set with evaluable data for this endpoint.||ng||Geometric Coefficient of Variation|Geometric Mean
822141|NCT01160822|Secondary|Area Under the Concentration Time Curve From Time Zero to Infinity AUC(0-inf)||Day 1, pre-dose and 1, 3, 6 and 8 hours post-dose (Part A only), Day 2, 4, 8, 15, 29, 57, 85 and 126.|Pharmacokinetic analysis set where data were available.||µg*day/mL||Standard Deviation|Mean
821423|NCT01153711|Primary|Maximum Concentration at Steady State (Cmax,ss)|Cmax,ss represents the maximum concentration of olodaterol and olodaterol glucuronide in plasma at steady state. The geometric mean is actually the adjusted geometric mean. The geometric coefficient of variation (gCV) is the intra-individual gCV.|Day 8 of period 1 and day 14 of period 2|PK analysis set with evaluable data for this endpoint.||Picogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
821424|NCT01153711|Primary|Area Under Curve From 0 to 1 Hour at Steady State (AUC0-1,ss)|AUC0-1,ss represents the area under the concentration curve of olodaterol in plasma from 0 to time t=1 hour at steady state, where t is defined as the latest time-point where at least 2/3 of the subjects in both treatment periods reveal quantifiable plasma concentrations of olodaterol. The geometric mean is actually the adjusted geometric mean. The geometric coefficient of variation (gCV) is the intra-individual gCV.|Day 8 of period 1 and day 14 of period 2|Pharmacokinetic (PK) analysis set includes all evaluable subjects in the treated set providing at least 1 observation for at least 1 PK endpoint without important protocol violations.||Picogram*hours/milliliter||Geometric Coefficient of Variation|Geometric Mean
821425|NCT01153724|Secondary|Assessment of Tolerability by the Investigator|The investigator assessed tolerability based on adverse events and the laboratory evaluation at the end-of-trial examination. The investigator classified the overall tolerability according to the categories 'good', 'satisfactory', 'not satisfactory', and 'bad'.|End of period 1 and end of period 2|TS||participants|||Number
821426|NCT01153724|Secondary|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG|Clinical relevant abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.|First administration of trial medication until 6 days after last administration of trial medication|Treated set (TS) - Treated set includes all patients who had taken at least 1 dose of trial medication.||participants|||Number
821427|NCT01153724|Secondary|Area Under Curve From 0 to 12 Hours at Steady State (AUC0-12,ss)|AUC0-12,ss represents the area under the concentration curve of olodaterol glucuronide in plasma from 0 to time t=12 at steady state, where t is defined as the latest timepoint where at least 2/3 of the subjects in both treatment periods reveal quantifiable plasma concentrations of the analyte. The geometric mean is actually the adjusted geometric mean. The geometric coefficient of variation (gCV) is the intra-individual gCV.|Day 8 of period 1 and day 14 of period 2|PK analysis set||Picogram*hours/milliliter||Geometric Coefficient of Variation|Geometric Mean
821428|NCT01153724|Secondary|Amount of the Analyte Excreted in Urine From 0 to 24 Hours at Steady State (Ae0-24,ss)|Ae0-24,ss represents the amount of olodaterol and olodaterol glucuronide excreted in urine from 0 to time t=24 at steady state. The geometric mean is actually the adjusted geometric mean. The geometric coefficient of variation (gCV) is the intra-individual gCV.|Day 8 of period 1 and day 14 of period 2|PK analysis set||ng||Geometric Coefficient of Variation|Geometric Mean
821429|NCT01153724|Secondary|Fraction of Urine Excretion From 0 to 24 Hours at Steady State (fe0-24,ss)|fe0-24,ss represents the fraction of olodaterol eliminated in urine from time point 0 to 24 hours after administration at steady state.|Day 8 of period 1 and day 14 of period 2|PK analysis set||percentage of olodaterol||Geometric Coefficient of Variation|Geometric Mean
821430|NCT01153724|Secondary|Time From Dosing to the Maximum Concentration at Steady State (Tmax,ss)|tmax,ss represents the time from dosing to maximum concentration of olodaterol and olodaterol glucuronide in plasma at steady state.|Day 8 of period 1 and day 14 of period 2|PK analysis set||Hours||Full Range|Median
821431|NCT01153724|Primary|Maximum Concentration at Steady State (Cmax,ss)|Cmax,ss represents the maximum concentration of olodaterol and olodaterol glucuronide (a metabolite of olodaterol) in plasma at steady state. The geometric mean is actually the adjusted geometric mean. The geometric coefficient of variation (gCV) is the intra-individual gCV.|Day 8 of period 1 and day 14 of period 2|PK analysis set||Picogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
821432|NCT01153724|Primary|Area Under Curve From 0 to 6 Hours at Steady State (AUC0-6,ss)|AUC0-6,ss represents the area under the concentration curve of olodaterol in plasma from 0 to time t=6 hours at steady state, where t is defined as the latest time-point where at least 2/3 of the subjects in both treatment periods reveal quantifiable plasma concentrations of olodaterol. The geometric mean is actually the adjusted geometric mean. The geometric coefficient of variation (gCV) is the intra-individual gCV.|Day 8 of period 1 and day 14 of period 2|Pharmacokinetic (PK) analysis set includes all evaluable subjects in the treated set providing at least 1 observation for at least 1 PK endpoint without important protocol violations.||Picogram*hours/milliliter||Geometric Coefficient of Variation|Geometric Mean
821433|NCT01153763|Secondary|Number of Participants With Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Levels|LVEF was defined as the percentage of blood pumped out of the left ventricle. Change from Baseline in worst-case post Baseline was presented as no change or any increase and any decrease values. Baseline was defined as the most recent non-missing value prior to the first dose of study treatment. The change from Baseline was calculated as visit value minus Baseline value and was presented in the form of worst-case post Baseline value which was the maximum toxicity grade for a participant after the first dose of study drug over the treatment period.|Up to 60 months|All treated Population||Participants|||Number
821434|NCT01153763|Secondary|Number of Participants With Increase From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Number of participants with increase from Baseline in SBP and DBP were evaluated from the first dose of study treatment till discontinuation due to any reason. Change from Baseline in worst-case post Baseline value was presented as any increase to >=80 and increase to >=100 for DBP and as any increase to >=120 and increase to >=160 for SBP. Baseline was defined as the most recent non-missing value prior to the first dose of study treatment. The change from Baseline was calculated as visit value minus Baseline value and was presented in the form of worst-case post Baseline value which was the maximum toxicity grade for a participant after the first dose of study drug over the treatment period. One participant out of the 92 participants (76 BRAF V600E patients + 16 BRAF V600K patients) did not have SBP and DBP collected after baseline.|Up to 60 months|All treated Population||Participants|||Number
821526|NCT01154036|Secondary|Percentage of Participants That Reach Target LDL-C Level of < 70 mg/dL (Phase I)||Week 6 (End of Phase I)|Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I and had at least 1 measurement after the start of study drug provided during Phase I.||Percentage of Participants|||Number
821435|NCT01153763|Secondary|Number of Participants With Change From Baseline in Temperature and Pulse Rate|Number of participants with change from Baseline in temperature and pulse rate were evaluated from the first dose of study treatment till discontinuation due to any reason. Change from Baseline in worst-case post Baseline value was presented as decrease to <=35, change to normal or no change and increase to >=38. Baseline was defined as the most recent non-missing value prior to the first dose of study treatment. The change from Baseline was calculated as visit value minus Baseline value and was presented in the form of worst case post-baseline value which was the maximum toxicity grade for a participant after the first dose of study drug over the treatment period.|Up to 60 months|All treated Population||Participants|||Number
821436|NCT01153763|Secondary|Number of Participants With Change From Baseline in Clinical Chemistry and Hematology Toxicity Grades|Blood samples were collected from participants for evaluation of change from Baseline in toxicity grades in clinical chemistry and hematology parameters. The clinical chemistry parameters included alkaline phosphatase, Alanine amino transferase (ALT), Aspartate amino transferase (AST), total bilirubin, creatinine, glucose, potassium, magnesium, sodium and phosphorus. The hematology parameters included hemoglobin, total neutrophils, platelets and white blood cells (WBC). Baseline was defined as the most recent non-missing value prior to the first dose of study treatment. The change from Baseline was calculated as visit value minus Baseline value and was presented in the form of worst case post-baseline value which was the maximum toxicity grade for a participant after the first dose of study drug over the treatment period. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|Up to 60 months|All treated Population||Participants|||Number
821437|NCT01153763|Secondary|Number of Participants With AEs and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs including systemic allergic and non-allergic reactions as well as local site injection-related reactions were counted throughout treatment phase and follow up phase. Systemic allergic reactions included facial paralysis, flushing, hypersensitivity and rash pruritic. Injection related reactions were considered as systemic non-allergic reactions. Local site reactions included injection site bruising, erythema, pain and reaction. The analysis was performed on All treated Population which comprised of all participants that receive at least one dose of dabrafenib.|Up to 60 months|All treated Population||Participants|||Number
821438|NCT01153763|Secondary|Overall Survival for Participants Who Had a BRAF V600K Mutation|Overall survival is defined as the time from the first dose of study medication until death due to any cause. For participants who did not die, overall survival was censored at the date of last contact. Overall survival was estimated using Kaplan-Meier model and median and 95 percent CI was presented.|From the first dose to death due to any cause (up to 60 months)|Secondary Efficacy Population||Weeks||95% Confidence Interval|Median
821439|NCT01153763|Secondary|Overall Survival for Participants Who Had a BRAF V600E Mutation|Overall survival is defined as the time from the first dose of study medication until death due to any cause. For participants who did not die, overall survival was censored at the date of last contact. Overall survival was estimated using kaplan-Meier model and median and 95 percent CI was presented.|Up to 60 months|Primary Efficacy Population||Weeks||95% Confidence Interval|Median
821440|NCT01153763|Secondary|Duration of Response as Assessed by the Investigator and an Independent Reviewer for Participants Who Had a BRAF V600K Mutation|Duration of response for participants with either a CR or PR is defined as the time from the first documented evidence of a PR or CR until the first documented sign of disease progression or death due to any cause. Duration of response was estimated using Kaplan-Meier model and the median and 95 percent CI was presented. The analysis was performed on Secondary efficacy Population and only those participants who had a CR or PR were analyzed.|Up to 60 months|Secondary Efficacy Population||Weeks||95% Confidence Interval|Median
821441|NCT01153763|Secondary|Duration of Response as Assessed by the Investigator and an Independent Reviewer for Participants Who Had a BRAF V600E Mutation|Duration of response for participants with either a CR or PR is defined as the time from the first documented evidence of a PR or CR until the first documented sign of disease progression or death due to any cause. Duration of response was estimated using Kaplan-Meier model and the median and 95 percent CI was presented. The analysis was performed on Primary efficacy Population and only those participants who had a CR or PR were analyzed.|Up to 60 months|Primary Efficacy Population||Weeks||95% Confidence Interval|Median
821442|NCT01153763|Secondary|Progression-free Survival (PFS) as Assessed by the Investigator and an Independent Reviewer for Participants Who Had a BRAF V600K Mutation|PFS is defined as the interval between the first dose of study medication and the earliest date of disease progression or death due to any cause. The length of this interval is estimated as the date of death or progression minus date of first dose plus 1 day. Kaplan-Meier model was used to estimate the median and 95 percent CI. For participants who received subsequent anti-cancer therapy prior to the date of documented progression or death, PFS was censored at the last adequate assessment. For participants who did not have a documented date of progression or death, PFS was censored at the date of last adequate assessment.|Up to 60 months|Secondary Efficacy Population||Weeks||95% Confidence Interval|Median
821443|NCT01153763|Secondary|Progression-free Survival (PFS) as Assessed by the Investigator and an Independent Reviewer for Participants Who Had a BRAF V600E Mutation|PFS is defined as the interval between the first dose of study medication and the earliest date of disease progression or death due to any cause. The length of this interval is estimated as the date of death or progression minus date of first dose plus 1 day. Kaplan-Meier model was used to estimate the median and 95 percent confidence interval (CI). For participants who received subsequent anti-cancer therapy prior to the date of documented progression or death, PFS was censored at the last adequate assessment. For participants who did not have a documented date of progression or death, PFS was censored at the date of last adequate assessment.|Up to 60 months|Primary Efficacy Population||Weeks||95% Confidence Interval|Median
821471|NCT01153958|Secondary|Number of Participants With Adverse Events (AEs)|An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.|Up to 2 months post-treatment|Safety population included all randomized participants who used the investigational product at least once.||participants|||Number
821444|NCT01153763|Secondary|Number of Participants With a Best Overall Response of CR or PR as Assessed by the Investigator and an Independent Reviewer for Participants Who Had a BRAF V600K Mutation|A participant was defined as a responder if he/she achieved either a CR (the disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis.) or PR (at least a 30 percent decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]). To be assigned a status of PR or CR, a confirmatory disease assessment had to have been performed at Week 12 if an initial response was seen at the Week 6 scan. Initial responses (CR/PR) that occured at Week 12 or later should have been confirmed not less than 4 weeks and not more than 6 weeks after the criteria for response were first met. The analysis was performed on Secondary efficacy analysis Population which comprised of all participants who received at least one dose of GSK2118436 (All Treated Participants Population) and had a BRAF V600K mutation.|Up to 60 months|Secondary Efficacy Population||Participants|||Number
821445|NCT01153763|Primary|Number of Participants With a Best Overall Response of Confirmed Complete Response (CR) or Partial Response (PR) as Assessed by the Investigator for Participants Who Had a BRAF V600E Mutation|A participant was defined as a responder if he/she achieved either a CR (the disappearance of all target lesions. Any pathological lymph nodes must be <10 millimeter (mm) in the short axis.) or PR (at least a 30 percent decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]). To be assigned a status of PR or CR, a confirmatory disease assessment was required at Week 12 if an initial response was seen at the Week 6 scan. Initial responses (CR/PR) that occured at Week 12 or later were required to be confirmed not less than 4 weeks and not more than 6 weeks after the criteria for response were first met. The analysis was performed on Primary efficacy Population which comprised of all participants who received at least one dose of GSK2118436 (All Treated Participants Population) and had a BRAF V600E mutation.|Up to 60 months|Primary efficacy Population||Participants|||Number
821446|NCT01153815|Secondary|GAS Score as Evaluated by the Care Giver or the Participants at the Indicated Time Points|The care giver or participants used the GAS to assess response to treatment at each visit after injection. The assessor was the same throughout the study period. GAS scores were assessed by using the 9-point GAS (-4, -3, -2, -1, -0, +1, +2, +3, +4; -4=very marked worsening, -0=unchanged, +4=very marked improvement) at the indicated time point.|Weeks 1, 4, 6, 8, and 12|FAS Population. The missing data imputation method was used for analysis.||scores on a scale||Standard Deviation|Mean
821447|NCT01153815|Secondary|Global Assessment Scale (GAS) Score as Evaluated by the Physician at the Indicated Time Points|The physician used the GAS to assess response to treatment at each visit after injection. The assessor was the same throughout the study period. GAS scores were assessed by using the 9-point GAS (-4, -3, -2, -1, -0, +1, +2, +3, +4; -4=very marked worsenig, -0=unchanged, +4=very marked improvement) at the indicated time points.|Weeks 1, 4, 6, 8, and 12|FAS Population. The missing data imputation method was used for analysis.||scores on a scale||Standard Deviation|Mean
821448|NCT01153815|Secondary|Change From Baseline at Weeks 1, 4, 6, 8, and 12 for Principal Measure as Assessed on the Disability Assessment Scale (DAS)|The investigator assessed 4 areas of disability, hygiene, pain, dressing, and limb posture, using the 4-point DAS (0=No functional disability to 3=Severe disability). Prior to the first dose, the investigator, in consultation with the participant, selected 1functional disability item (which had to have a score of 2 or greater as measured on the DAS, indicating moderate to severe disability) from the 4 areas of disability and assessed it as a principal measure. Change from Baseline at the indicated time points was calculated as the value at Weeks 1, 4, 6, 8, and 12 minus the value at Baseline.|Baseline (Day 0) and Weeks 1, 4, 6, 8, and 12|FAS Population. The missing data imputation method was used for analysis.||scores on a scale||Standard Deviation|Mean
821449|NCT01153815|Secondary|Change From Baseline at Weeks 1, 4, 6, 8 and 12 for Thumb Flexor Muscle Tone as Measured on the MAS|The investigator, physotherapist, or occupational therapist extended the participant's thumb as quickly as possible to grade the flexor muscle tone. The MAS thumb score was calculated by using the 6-point MAS (0, 1, 1+ [regarded as 1.5], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part[s] rigid in flexion/extension). Change from Baseline at the indicated time points was calculated as the value at Week 1, 4, 6, 8, and 12 minus the value at Baseline.|Baseline (Day 0) and Weeks 1, 4, 6, 8, and 12|FAS Population. Only participants with thumb spasticity who received injection in the thumb muscles were evaluated. The missing data imputation method was used for analysis.||scores on a scale||Standard Deviation|Mean
821450|NCT01153815|Secondary|Change From Baseline at Weeks 1, 4, 6, 8, and 12 for Finger Flexor Muscle Tone as Measured on the MAS|The investigator, physiotherapist, or occupational therapist extended the participant's finger as quickly as possible to grade the flexor muscle tone. The MAS finger score was calculated by using the 6-point MAS (0, 1, 1+ [regarded as 1.5], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part[s] rigid in flexion/extension). Change from Baseline at the indicated time points was calculated as the value at Week 1, 4, 6, 8, and 12 minus the value at Baseline.|Baseline (Day 0) and Weeks 1, 4, 6, 8, and 12|FAS Population. The missing data imputation method was used for analysis.||scores on a scale||Standard Deviation|Mean
821451|NCT01153815|Secondary|Number of Participants Classified as Wrist Treatment Responders at All Post-injection Visits|Wrist treatment responders were defined as participants with a decrease in wrist flexor muscle tone of at least one point on the MAS. The MAS wrist score was calculated by using the 6-point MAS (0, 1, 1+ [regarded as 1.5], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part[s] rigid in flexion/extension).|Weeks 1, 4, 6, 8, and 12|FAS Population. The missing data imputation method was used for analysis.||participants|||Number
821452|NCT01153815|Secondary|Change From Baseline at Weeks 1, 4, 8, and 12 for Wrist Flexor Muscle Tone as Measured on the MAS|The investigator, physiotherapist, or occupational therapist extended the participant's wrist as quickly as possible to grade flexor muscle tone. The MAS wrist score was calculated by using the 6-point MAS (0, 1, 1+ [regarded as 1.5], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part[s] rigid in flexion/extension). Change from Baseline at the indicated time points was calculated as the value at the indicated time points minus the value at Baseline.|Baseline (Day 0) and Weeks 1, 4, 8, and 12|FAS Population. The missing data imputation method was used for analysis.||scores on a scale||Standard Deviation|Mean
821748|NCT01155323|Primary|Limbal Hyperemia|This outcome is assessed by the investigator during biomicroscopy examination using the following 0-4 scale: 0 = none, 1 = trace, 2 = mild, 3= moderate, 4 = severe.|after 1 week of wear|The analysis population represents subjects that completed the study per protocol.||Units on a scale||Standard Error|Least Squares Mean
821453|NCT01153815|Secondary|Area Under the Curve (AUC) for the Change From Baseline at Weeks 6 and 12 for MAS Wrist Score|The MAS wrist score was assessed by using the 6-point MAS (0, 1, 1+ [regarded as 1.5], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part[s] rigid in flexion/extension). Mean change from Baseline for the MAS wrist score was calculated as the value at Week 6 and Week 12 minus the value at Baseline. In a graph plotting time points on the horizontal axis (HA) and changes from Baseline on the vertical axis, the area surrounded by the MAS wrist score change curve and the HA was calculated and used as a summary index (AUC) for assessment of the MAS wrist score.|Baseline (Day 0), Week 6, and Week 12|FAS Population. The missing data imputation method was used for analysis.||scores on a scale||Standard Deviation|Mean
821454|NCT01153815|Primary|Change From Baseline at Week 6 for Wrist Flexor Muscle Tone as Measured on the Modified Ashworth Scale (MAS)|The investigator, physiotherapist, or occupational therapist extended the participant's wrist as quickly as possible to grade flexor muscle tone. The MAS wrist score was calculated by using the 6-point MAS (0, 1, 1+ [regarded as 1.5], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part[s] rigid in flexion/extension). Change from Baseline at Week 6 was calculated as the value at Week 6 minus the value at Baseline.|Baseline (Day 0) and Week 6|Full Analysis Set (FAS) Population: all randomized and treated participants. The missing data imputation method was used for analysis. For each participant, missing data points were replaced by the mean of the non-missing scores from both treatment groups for that variable at the specific visit.||scores on a scale||Standard Deviation|Mean
821455|NCT01153841|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|After the first vaccination up to study end (From Month 0 to Month 3)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subjects|||Number
821456|NCT01153841|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. “Any” is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.|During the 31-day (Days 0-30) follow-up period after each dose|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subjects|||Number
821457|NCT01153841|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms assessed include drowsiness, fever (defined as axillary temperature ≥ 37.5°C), irritability, and loss of appetite. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (axillary temperature) above (>) 39.5 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all. “Any” is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination.|During the 4-day (Days 0-3) post-vaccination period following each dose|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented and with the symptom sheet filled in.||Subjects|||Number
821458|NCT01153841|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (>) 30 millimeters (mm). “Any” is defined as incidence of the specified symptom regardless of intensity.|During the 4-day (Days 0-3) post-vaccination period following each dose|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented and with the symptom sheet filled in.||Subjects|||Number
821459|NCT01153841|Primary|Number of Subjects With Grade 3 Symptoms (Solicited and Unsolicited)|The incidence and nature of Grade 3 symptoms (solicited and unsolicited) reported during the 31-day post-vaccination period following each dose and across doses are presented.|Within the 31-day (Days 0-30) after each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented and with the symptom sheet filled in.||Subjects|||Number
821460|NCT01153893|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|During the entire study period, from the vaccination visit at Day 0 up to the end of the follow-up visit at Month 1 for the Synflorix/Infanrix primed Group and up to Month 3 for the Synflorix/Infanrix unprimed Group.|The Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
821461|NCT01153893|Secondary|Number of Subjects Reporting Unsolicited AEs.|Unsolicited AEs = Any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study. Also any “solicited” symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.|Within 31 days (Days 0-30) after vaccination|The Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
821462|NCT01153893|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs.|"Solicited general symptoms assessed were drowsiness, irritability, loss of appetite and fever (= axillary temperature equal to or above 37.5 degrees Celsius (°C)).
Any= occurrence of any general symptom regardless of intensity grade or relationship to vaccination Grade 3 drowsiness = drowsiness which prevented normal activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = temperature >39.5°C.
Related = solicited symptom assessed by the investigator as causally related to study vaccination."|Within 4 days (Days 0-3) after vaccination.|The Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
821749|NCT01155323|Primary|Subjective Rating of Quality Perceptions|This outcome is a weighted combined score calculated from individual quality perception-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.|after 1 week of lens wear|The analysis population represents subjects that completed the study per protocol.||Units on a scale||Standard Error|Least Squares Mean
821463|NCT01153893|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local AEs.|"Solicited AEs = AEs to be recorded as endpoints in the clinical study. The presence/occurrence/intensity of these events was actively solicited from the subject or an observer during a specified post-vaccination follow-up period.
Solicited local symptoms assessed were pain, redness and swelling.
Any = occurrence of any local symptom regardless of intensity grade.
Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimetre (mm)"|Within 4 days (Days 0-3) after vaccination.|The Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
821464|NCT01153893|Secondary|Concentration of Antibodies Against Protein D (PD).|Anti-PD antibodies were determined using an ELISA assay. Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA units per millilitre (EL.U/mL). Concentration of specific PD antibodies was determined, using a standard reference serum. The cut-off of the assay is 100 ELISA units per millilitre (EL.U/mL).|Prior to and one month after the booster immunisation for the Synflorix/Infanrix primed Group and prior to the first dose and one month after Dose 2 in the Synflorix/Infanrix unprimed Group|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D for the blood sample taken one month after vaccination.||EL.U/mL||95% Confidence Interval|Geometric Mean
821465|NCT01153893|Secondary|Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes.|"Cross-reactive pneumococcal serotypes assessed were serotypes 6A and 19A.
Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results were presented as the dilution of serum (opsonic titre) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay is an opsonic titre of 8."|One month after the booster immunisation for the Synflorix/Infanrix primed Group and one month after Dose 2 in the Synflorix/Infanrix unprimed Group|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D for the blood sample taken one month after vaccination.||Titres||95% Confidence Interval|Geometric Mean
821466|NCT01153893|Secondary|Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes.|"Vaccine pneumococcal serotypes assessed were serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results were presented as the dilution of serum (opsonic titre) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay is an opsonic titre of 8."|One month after the booster immunisation for the Synflorix/Infanrix primed Group and one month after Dose 2 in the Synflorix/Infanrix unprimed Group|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D for the blood sample taken one month after vaccination.||Titres||95% Confidence Interval|Geometric Mean
821467|NCT01153893|Secondary|Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes.|"Cross-reactive pneumococcal serotypes assessed were serotypes 6A and 19A. Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL).
The antibody concentrations against the cross-reactive pneumococcal serotypes 6A and 19A were determined by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 0.05 µg/mL."|Prior to and one month after the booster immunisation for the Synflorix/Infanrix primed Group and prior to the first dose and one month after Dose 2 in the Synflorix/Infanrix unprimed Group|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D for the blood sample taken one month after vaccination.||µg/mL||95% Confidence Interval|Geometric Mean
821468|NCT01153893|Secondary|Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.|"Vaccine pneumococcal serotypes assessed were serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL).
Pneumococcal serotype specific total imunoglobuline G (IgG) antibodies were measured by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 0.05 µg/mL."|Prior to and one month after the booster immunisation for the Synflorix/Infanrix primed Group and prior to the first dose and one month after Dose 2 in the Synflorix/Infanrix unprimed Group|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D for the blood sample taken one month after vaccination.||µg/mL||95% Confidence Interval|Geometric Mean
821469|NCT01153893|Primary|Number of Subjects Reporting Grade 3 Symptoms (Solicited and Unsolicited).|"Grade 3 symptom = severe symptom that prevented normal activity.
Solicited local symptoms assessed were pain, redness and swelling.
Solicited general symptoms assessed were drowsiness, fever, irritability and loss of appetite.
Unsolicited AEs = Any AE reported in addition to those solicited during the clinical study. Also any “solicited” symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event."|Within 31 days (Day 0 to Day 30) after administration of a booster dose of Synflorix vaccine in the Synflorix/Infanrix primed Group.|The Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
821470|NCT01153958|Secondary|Percentage of Participants Cured|Cure was defined as Nugent score less than 7, no symptoms of vaginal irritation (for example, pain, burning, odour or abnormal vaginal discharge). Nugent score was calculated by assessing for presence of large Gram-positive rods (Lactobacillus morphotypes; decrease in Lactobacillus scored as 0-4), small Gram-variable rods (Gardnerella vaginalis morphotypes; scored as 0-4), and curved Gram-variable rods (Mobiluncus species morphotypes; scored as 0-2). Total score range: 0-10. Score of 7-10 indicated bacterial vaginosis.|1 week post-treatment|FAS population included all enrolled participants who used investigational product. 'N' (number of participants analyzed) signifies those participants who were evaluated for this measure.||percentage of participants|||Number
822142|NCT01160822|Secondary|Area Under the Concentration Time Curve up to the Last Measurable Concentration (AUClast)||Day 1, pre-dose and 1, 3, 6 and 8 hours post-dose (Part A only), Day 2, 4, 8, 15, 29, 57, 85 and 126.|Pharmacokinetic analysis set where data were available.||µg*day/mL||Standard Deviation|Mean
821472|NCT01153958|Secondary|Change From Baseline in Number of Participants With Each Grade of Lactobacilli at 2 Months Post-treatment|The grades of Lactobacilli in vaginal discharge were Grade 1 (Normal): Lactobacillus morphotypes predominate; Grade 2 (Intermediate): Mixed flora with some Lactobacilli present, but Gardnerella or Mobiluncus morphotypes also present; Grade 3 (Bacterial Vaginosis): Predominantly Gardnerella and/or Mobiluncus morphotypes, few or absent Lactobacilli.|Baseline and Month 2 post-treatment|FAS population included all enrolled participants who used investigational product. 'N' (number of participants analyzed) signifies those participants who were evaluated for this measure. 'n' signifies those participants who were evaluated for this measure at the time point.||participants|||Number
821473|NCT01153958|Secondary|Change From Baseline in Nugent Score at 2 Months Post-treatment|Nugent score was calculated by assessing for presence of large Gram-positive rods (Lactobacillus morphotypes; decrease in Lactobacillus scored as 0-4), small Gram-variable rods (Gardnerella vaginalis morphotypes; scored as 0-4), and curved Gram-variable rods (Mobiluncus species morphotypes; scored as 0-2). Total score range: 0-10. Score of 7-10 indicate bacterial vaginosis.|Baseline and Month 2 post-treatment|FAS population included all enrolled participants who used investigational product. 'n' signifies those participants who were evaluated for this measure at the time point.||units on a scale||Standard Deviation|Mean
821474|NCT01153958|Secondary|Percentage of Participants With Relapse 1 Month Post-treatment|Relapse: recurrence of the symptoms of bacterial vaginosis [BV] (Nugent score greater than or equal to 7, symptoms of vaginal irritation for example, pain, burning, odour or abnormal vaginal discharge) after a period of improvement. Nugent score was calculated by assessing for presence of large Gram-positive rods (Lactobacillus morphotypes; decrease in Lactobacillus scored as 0-4), small Gram-variable rods (Gardnerella vaginalis morphotypes; scored as 0-4), and curved Gram-variable rods (Mobiluncus species morphotypes; scored as 0-2). Total score range: 0-10. Score of 7-10 indicated BV.|1 month post-treatment|FAS population included all enrolled participants who used investigational product. 'N' (number of participants analyzed) signifies those participants who were evaluated for this measure.||percentage of participants|||Number
821475|NCT01153958|Primary|Percentage of Participants With Relapse 2 Months Post-treatment|Relapse: recurrence of the symptoms of bacterial vaginosis [BV] (Nugent score greater than or equal to 7, symptoms of vaginal irritation for example, pain, burning, odour or abnormal vaginal discharge) after a period of improvement. Nugent score was calculated by assessing for presence of large Gram-positive rods (Lactobacillus morphotypes; decrease in Lactobacillus scored as 0-4), small Gram-variable rods (Gardnerella vaginalis morphotypes; scored as 0-4), and curved Gram-variable rods (Mobiluncus species morphotypes; scored as 0-2). Total score range: 0-10. Score of 7-10 indicated BV.|2 months post-treatment|Full analysis set (FAS) population included all enrolled participants who used investigational product. 'N' (number of participants analyzed) signifies those participants who were evaluated for this measure.||percentage of participants|||Number
821476|NCT01153971|Secondary|DR - Time to Event|DR was defined for all participants who achieved a response (CR, CRu and PR) at month 1 after the completion of treatment of the induction phase (Month 7 of the study) and was measured from the time of response until the date of progression or relapse. Participants without relapse or progression were censored at their last assessment date. Participants who died due to tumour were considered in progression. Participants who died for any other cause were censored to the death date.|Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40|ITT population: only participants who achieved a response (CR, CRu and PR) at month 1 after the completion of treatment of the induction phase of the study were included in the analysis.||months||Standard Error|Mean
821477|NCT01153971|Secondary|DR - Percentage of Participants With an Event|DR was defined for all participants who achieved a response (CR, CRu and PR) at month 1 after the completion of treatment of the induction phase (Month 7 of the study) and was measured from the time of response until the date of progression or relapse. Participants without relapse or progression were censored at their last assessment date. Participants who died due to tumour were considered in progression. Participants who died for any other cause were censored to the death date.|Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40|ITT population; only participants who achieved a response (CR, CRu and PR) at month 1 after the completion of treatment of the induction phase of the study were included in the analysis.||percentage of participants|||Number
821478|NCT01153971|Secondary|Duration of Response (DR) - Percentage of Participants Expected to Maintain a Response|DR data were analyzed using Kaplan-Meier survival analysis. DR was defined for all participants who achieved a response (CR, CRu and PR) at month 1 after the completion of treatment of the induction phase (Month 7 of the study) and was measured from the time of response until the date of progression or relapse. Participants without relapse or progression were censored at their last assessment date. Participants who died due to tumour were considered in progression. Participants who died for any other cause were censored to the death date.|Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40|ITT population; only participants who achieved a response (CR, CRu and PR) at month 1 after the completion of treatment of the induction phase of the study were included in the analysis.||percentage of participants||95% Confidence Interval|Number
821479|NCT01153971|Secondary|PFS - Time to Event|Progression-free survival was defined as the time from treatment start to the date of documented disease progression. NOTE: The mean survival time and its standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time.|Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40|ITT population||months||Standard Error|Mean
821480|NCT01153971|Secondary|PFS - Percentage of Participants With an Event|Progression-free survival was defined as the time from the date of treatment start to the date of documented disease progression.|Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40|ITT population||percentage of participants|||Number
821481|NCT01153971|Secondary|Progression-free Survival (PFS) - Percentage of Participants Estimated to Be Progress Free|PFS data were analyzed using Kaplan-Meier survival analysis. PFS was defined as the time from treatment start to the date of documented disease progression. Reported data refer to values up to 40 months.|Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40|ITT population||percentage of participants||95% Confidence Interval|Number
821527|NCT01154036|Secondary|Percentage of Participants That Reach Target LDL-C Level of < 100 mg/dL (Phase II)||Week 12 (End of Phase II)|Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II and had at least 1 measurement after the start of Phase II||Percentage of Participants|||Number
821482|NCT01153971|Secondary|DFS - Time to Event|DFS was defined for all participants who achieved a complete response (CR/CRu) at month 1 after the completion of treatment of the induction phase (month 7 of the study) and was measured from the time of complete response to the date of relapse. Participants without relapse were censored at their last assessment date. Participants who died due to tumour burden were considered in relapse. Participants who died due to any other causes were censored on the death date. NOTE: The mean survival time and its standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time.|Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40.|ITT population; only participants who achieved a complete response (CR/CRu) at month 1 after the completion of treatment of the induction phase were included in the analysis.||months||Standard Error|Mean
821483|NCT01153971|Secondary|DFS - Percentage of Participants With an Event|DFS was defined for all patients who achieved a complete response (CR/CRu) at month 1 after the completion of treatment of the induction phase (month 7 of the study) and was measured from the time of complete response to the date of relapse. Participants without relapse were censored at their last assessment date. Participants who died due to tumour burden were considered in relapse. Participants who died due to any other causes were censored on the death date.|Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40.|ITT population; only participants who achieved a complete response (CR/CRu) at month 1 after the completion of treatment of the induction phase were included in the analysis.||percentage of participants|||Number
821484|NCT01153971|Secondary|Disease-Free Survival (DFS) - Percentage of Participants Estimated to be Disease-Free|DFS data were analyzed using Kaplan-Meier survival analysis. DFS was defined for all participants who achieved a complete response (CR/CRu) at month 1 after the completion of treatment of the induction phase (Month 7 of the study) and was measured from the time of CR to the date of relapse. Participants without relapse were censored at their last assessment date. Participants who died due to tumour burden were considered in relapse. Participants who died due to any other causes were censored as of the death date. The reported data refer to values up to 40 months.|Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40|ITT population; only participants who achieved a complete response (CR/CRu) at month 1 after the completion of treatment of the induction phase were included in the analysis.||percentage of participants||95% Confidence Interval|Number
821485|NCT01153971|Secondary|OS - Time to Event|Overall survival was defined as the time from first dosage of study drug to the date of death from any cause.|Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40.|ITT population||months||Standard Error|Mean
821486|NCT01153971|Secondary|OS - Percentage of Participants With an Event|OS was defined as the time from first dosage of study drug to the date of death from any cause.|Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40.|ITT population||percentage of participants|||Number
821487|NCT01153971|Secondary|Overall Survival (OS) - Percentage of Participants Estimated to be Alive|OS data were analyzed using Kaplan-Meier survival analysis. OS was defined as the time from first dosage of study drug to the date of death from any cause. Reported data refer to values up to 40 months.|Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40|ITT population||percentage of participants||95% Confidence Interval|Number
821488|NCT01153971|Secondary|FFS - Time to Event|FFS was measured from the date of treatment start to the date of documented disease progression, relapse or death from any cause. Responding participants, participants who were lost to follow up, who withdrew consent or dropped out due to AEs were censored at their last assessment date. NOTE: The mean survival time and its standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time.|Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40|ITT population||months||Standard Error|Mean
821489|NCT01153971|Secondary|FFS - Percentage of Participants With an Event|FFS was measured from the date of treatment start to the date of documented disease progression, relapse, or death from any cause. Responding participants, participants who were lost to follow up, who withdrew consent, or who dropped out due to AEs were censored at their last assessment date.|Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40|ITT population||percentage of participants|||Number
821490|NCT01153971|Secondary|Failure-Free Survival (FFS), Percentage of Participants Estimated to be Free of Documented Disease Progression, Relapse, or Death|FFS data were analyzed using Kaplan-Meier survival analysis. FFS was measured from the date of treatment start to the date of documented disease progression, relapse, or death from any cause. Responding participants, participants who were lost to follow up, who withdrew consent, or dropped out due to adverse events (AE) were censored at their last assessment date. The reported data refer to values up to 40 months.|Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40|ITT population||percentage of participants||95% Confidence Interval|Number
821491|NCT01153971|Secondary|Percentage of Participants Achieving a Response by Response Type and Study Phase|CR: complete disappearance of all symptoms/objective signs of disease (enlarged lymph nodes, hepatomegaly, splenomegaly) for at least 3 months following definitive re-evaluation at end of therapy. For initial bone marrow involvement, clearance of bone marrow documented by biopsy, normalization of blood counts with granulocytes greater than (>)1,500 per microliter (/µL), hemoglobin >12 grams per deciliter (g/dL), platelets >100,000/µL. CRu: disappearance of all symptoms and nearly all measurable lesions, but persistence of some radiologic abnormalities with normalization of all biologic abnormalities; normalization of the performance status for at least 3 months after the definite evaluation of therapy. PR: at least 50 percent (%) reduction of measurable and evaluable lymphoma involvement for at least 4 weeks without occurrence of new manifestations, normalization of blood counts. Participants without evaluation at end of induction/maintenance phase were considered nonresponders.|Baseline, Months 4, 7, 11, 16, 22, 28, 34, and 40|ITT population||percentage of participants|||Number
821504|NCT01154036|Secondary|Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) (Phase I)|hs-CRP measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4. Baseline and post-baseline measurements were log-transformed in the response vector, with fixed effects for treatment, time and the interaction of time by treatment.|Baseline and Week 6 (end of Phase I)|Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I and had at least 1 measurement after the start of study drug provided during Phase I.||Percentage Change||95% Confidence Interval|Least Squares Mean
821492|NCT01153971|Secondary|Percentage of Participants Achieving a Best Overall Response of CR, CRu, or PR by Study Phase|CR: complete disappearance of all symptoms/objective signs of disease (enlarged lymph nodes, hepatomegaly, splenomegaly) for at least 3 months following definitive re-evaluation at end of therapy. For initial bone marrow involvement, clearance of bone marrow documented by biopsy, normalization of blood counts with granulocytes greater than (>)1,500 per microliter (/µL), hemoglobin >12 grams per deciliter (g/dL), platelets >100,000/µL. CRu: disappearance of all symptoms and nearly all measurable lesions, but persistence of some radiologic abnormalities with normalization of all biologic abnormalities; normalization of the performance status for at least 3 months after the definite evaluation of therapy. PR: at least 50 percent (%) reduction of measurable and evaluable lymphoma involvement for at least 4 weeks without occurrence of new manifestations, normalization of blood counts. Participants without evaluation at end of induction/maintenance phase were considered nonresponders.|Baseline, Months 4, 7 (Induction Phase), 11, 16 (Maintenance Phase),22, 28, 34, and 40(Follow-Up Phase)|ITT population||percentage of participants||95% Confidence Interval|Number
821493|NCT01153971|Primary|Percentage of Participants Remaining Failure-Free After 2 Years From Treatment Start Date|Percentage of participants who at 2 years from the start of treatment remained free from documented disease progression, relapse, or death. Failure status was based on tumor evaluation performed on Month 28. Participants who did not have a tumor evaluation at Month 28 were counted as failures.|Month 28|ITT population||percentage of participants||95% Confidence Interval|Number
821494|NCT01153984|Secondary|Percentage of Similar EGFR Mutations Between Matched Plasma and Tumor Tissue Samples||Baseline up to approximately 4 years|No participants were analyzed for this outcome as no plasma samples were collected during the study.|||||
821495|NCT01153984|Secondary|Number of EGFR Positive Participants Classified Based on Type of EGFR Mutations|Participants with NSCLC have tumor associated with EGFR mutations. These mutations occur within EGFR Exons 18-21, which encodes a portion of the EGFR kinase domain.|Day 1|All enrolled participants.||participants|||Number
821496|NCT01153984|Secondary|Number of EGFR Positive Participants Classified Based on Smoking Status|Participants were asked: “Have you smoked at least 100 cigarettes in your entire life?” and “Do you now smoke cigarettes every day, some days, or not at all?” Responses were grouped into three categories: Current Smoker, Former Smoker, and Non-Smoker. Participants who reported smoking at least 100 cigarettes in their lifetime and who, at the time of survey, smoked either every day or some days were defined as 'Current smoker'. Participants who reported smoking at least 100 cigarettes in their lifetime and who, at the time of the survey, did not smoke at all were defined as 'Former smoker'. Participants who reported never having smoked 100 cigarettes were defined as 'Non-smoker'.|Day 1|All enrolled participants.||participants|||Number
821497|NCT01153984|Secondary|Percentage of Participants by Localization of PD, as Assessed by Investigator Using RECIST v1.1|PD was assessed using RECIST v1.1. PD was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions. Percentage of participants by localization of PD were reported. Localization included: Left lung inferior lobe; Para-aortic; Left lung upper lobe; Right lung inferior lobe; and Infracranial.|Baseline up to approximately 4 years|All enrolled participants with available data for this outcome.||percentage of participants|||Number
821498|NCT01153984|Secondary|Percentage of Participants Who Were Alive One Year After Study Treatment Initiation||Year 1|All enrolled participants with available data for this outcome.||percentage of participants|||Number
821499|NCT01153984|Secondary|Percentage of Participants With Complete Response (CR) And Partial Response (PR) as Assessed by the Investigator Using RECIST v1.1|CR was defined as the disappearance of all target lesions, and PR was defined as at least a 30% decrease in the sum of the longest diameter compared to baseline.|Baseline up to approximately 4 years|All enrolled participants.||percentage of participants|||Number
821500|NCT01153984|Secondary|Time to Disease Progression, as Assessed by Investigator Using RECIST v1.1|Time to disease progression was defined as the time from baseline evaluation to the first date PD was recorded. Participants without progression were censored at the date of last tumor assessment where non-progression was documented. PD was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.|Baseline up to approximately 4 years|All enrolled participants.||days||95% Confidence Interval|Median
821501|NCT01153984|Primary|Progression-Free Survival (PFS), as Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)|PFS was the time from inclusion in the study to the date of first documented PD or death from any cause, whichever occurred first. Participants without event were censored at the date of the last tumor assessment where non-progression was documented. If a participant received a second anti-cancer therapy without prior documentation of disease progression, the participant was censored at the date of last tumor assessment before starting new chemotherapy. Analysis was performed using Kaplan-Meier method. PD was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.|Baseline up to approximately 4 years|All enrolled participants.||days||95% Confidence Interval|Median
821502|NCT01154010|Primary|Inflammation Grade at Day 7|Degree and grade of ocular inflammation based on Standard Uveitis Nomenclature will be assessed at initial visit, Day 3, and Day 7 of use of the PEMF device to assess if the PEMF device decreases the duration and severity of ocular inflammation when used as an adjunctive therapy for anterior uveitis. The results posted here are from day 7. The Standard Uveitis Nomenclature scale ranges from 0 to 4, with 0 indicating a minimal level of ocular inflammation and 4 indicating the maximal level of corneal inflammation.|7 days|||units on a scale||Standard Deviation|Mean
821503|NCT01154036|Secondary|Percent Change From Baseline in Hs-CRP (Phase II)|hs-CRP measured at Baseline (Week 6; end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6. Baseline and post-baseline measurements were log-transformed in the response vector, with fixed effects for treatment, time and the interaction of time by treatment.|Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)|Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II and had at least 1 measurement after the start of Phase II||Percentage Change||95% Confidence Interval|Least Squares Mean
821505|NCT01154036|Secondary|Percent Change From Baseline in Non-HDL-C/HDL-C Ratio (Phase II)|Non HDL-C/HDL-C Ratio calculated at baseline (Week 6; end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.|Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)|Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II or had at least 1 measurement after the start of Phase II||Percentage Change||Standard Deviation|Median
821506|NCT01154036|Secondary|Percent Change From Baseline in Non-HDL-C/HDL-C Ratio (Phase I)|Non HDL-C/HDL-C ratio calculated at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4|Baseline and Week 6 (end of Phase I)|Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I or had at least 1 measurement after the start of study drug provided during Phase I.||Percentage Change||Standard Deviation|Median
821507|NCT01154036|Secondary|Percent Change From Baseline in Apo B/Apo A-I Ratio (Phase II)|Apo B/Apo A-I Ratio calculated at Baseline (Week 6; end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.|Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)|Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II or had at least 1 measurement after the start of Phase II||Percentage Change||Standard Deviation|Median
821508|NCT01154036|Secondary|Percent Change From Baseline in Apo B/Apo A-I Ratio (Phase I)|Apo B/Apo A-I ratio calculated at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4|Baseline and Week 6 (end of Phase I)|Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I or had at least 1 measurement after the start of study drug provided during Phase I.||Percentage Change||Standard Deviation|Median
821509|NCT01154036|Secondary|Percent Change From Baseline in LDL-C/HDL-C Ratio (Phase II)|LDL-C/HDL-C Ratio calculated at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.|Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)|Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II or had at least 1 measurement after the start of Phase II||Percentage Change||Standard Deviation|Median
821510|NCT01154036|Secondary|Percent Change From Baseline in LDL-C/HDL-C Ratio (Phase I)|LDL-C/HDL-C ratio calculated at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4|Baseline and Week 6 (end of Phase I)|Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I or had at least 1 measurement after the start of study drug provided during Phase I.||Percentage Change||Standard Deviation|Median
821511|NCT01154036|Secondary|Percent Change From Baseline in TC/HDL-C Ratio (Phase II)|TC/HDL-C Ratio calculated at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.|Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)|Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II or had at least 1 measurement after the start of Phase II||Percentage Change||Standard Deviation|Median
821512|NCT01154036|Secondary|Percent Change From Baseline in TC/HDL-C Ratio (Phase I)|TC/HDL-C ratio calculated at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4|Baseline and Week 6 (end of Phase I)|Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I or had at least 1 measurement after the start of study drug provided during Phase I.||Percentage Change||Standard Deviation|Median
821513|NCT01154036|Secondary|Percent Change From Baseline in Non-HDL-C (Phase II)|Non-HDL-C levels calculated at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.|Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II)|Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II or had at least 1 measurement after the start of Phase II||Percentage Change||Standard Deviation|Median
821514|NCT01154036|Secondary|Percent Change From Baseline in Non-HDL-C (Phase I)|Non-HDL-C measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4|Baseline and Week 6 (end of Phase I)|Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I or had at least 1 measurement after the start of study drug provided during Phase I.||Percentage Change||Standard Deviation|Median
821525|NCT01154036|Secondary|Percentage of Participants That Reach Target LDL-C Level of < 70 mg/dL (Phase II)||Week 12 (end of Phase II)|Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II and had at least 1 measurement after the start of Phase II||Percentage of Participants|||Number
821515|NCT01154036|Secondary|Percent Change From Baseline in Apo A-I (Phase II)|Apo-A-I levels measured at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.|Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II)|Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II or had at least 1 measurement after the start of Phase II||Percentage Change||Standard Deviation|Median
821516|NCT01154036|Secondary|Percent Change From Baseline in Apolipoprotein A-I (Apo A-I) (Phase I)|Apo-A-I measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4|Baseline and Week 6 (end of Phase I)|Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I or had at least 1 measurement after the start of study drug provided during Phase I.||Percentage Change||Standard Deviation|Median
821517|NCT01154036|Secondary|Percent Change From Baseline in Apo B (Phase II)|Apo-B levels measured at Baseline (Week 6; end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.|Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)|Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II or had at least 1 measurement after the start of Phase II||Percentage Change||Standard Deviation|Median
821518|NCT01154036|Secondary|Percent Change From Baseline in Apolipoprotein B (Apo B) (Phase I)|Apo-B measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4|Baseline and Week 6 (end of Phase I)|Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I or had at least 1 measurement after the start of study drug provided during Phase I.||Percentage Change||Standard Deviation|Median
821519|NCT01154036|Secondary|Percent Change From Baseline in HDL-C (Phase II)|HDL-C levels measured at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.|Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II)|Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II or had at least 1 measurement after the start of Phase II||Percentage Change||Standard Deviation|Median
821520|NCT01154036|Secondary|Percent Change From Baseline in High-density Lipoprotein-Cholesterol (HDL-C) (Phase I)|HDL-C measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4|Baseline and Week 6 (end of Phase I)|Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I or had at least 1 measurement after the start of study drug provided during Phase I.||Percentage Change||Standard Deviation|Median
821521|NCT01154036|Secondary|Percent Change From Baseline in Triglycerides (TG) (Phase II)|TG levels measured at Baseline (Week 6: end of Phase I) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6. Baseline and post-baseline measurements were log-transformed in the response vector, with fixed effects for treatment, time and the interaction of time by treatment.|Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II)|Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II and had at least 1 measurement after the start of Phase II||Percentage Change||95% Confidence Interval|Least Squares Mean
821522|NCT01154036|Secondary|Percent Change From Baseline in Triglycerides (TG) (Phase I)|TG measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4. Baseline and post-baseline measurements were log-transformed in the response vector, with fixed effects for treatment, time and the interaction of time by treatment.|Baseline and Week 6 (end of Phase I)|Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I and had at least 1 measurement after the start of study drug provided during Phase I.||Percentage Change||95% Confidence Interval|Least Squares Mean
821523|NCT01154036|Secondary|Percent Change From Baseline in Total Cholesterol (TC) (Phase II)|TC levels measured at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.|Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II)|Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II or had at least 1 measurement after the start of Phase II||Percentage Change||Standard Deviation|Median
821524|NCT01154036|Secondary|Percent Change From Baseline in Total Cholesterol (TC) (Phase I)|TC measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4|Baseline and Week 6 (end of Phase I)|Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I or had at least 1 measurement after the start of study drug provided during Phase I.||Percentage Change||Standard Deviation|Median
822108|NCT01160614|Primary|Single- and Multiple-dose PK Metric: Time to Maximum Plasma Concentration From Hour 0 to 12 Hours of the First Dose of ORF (Tmax 0-12)||Up to 12 hours|The full analysis population for PK (N = 30) was defined as patients who received at least 1 dose of oral study drug and had at least 1 valid quantifiable PK metric||h||Full Range|Median
821528|NCT01154036|Secondary|Percentage of Participants That Reach Target LDL-C Level of < 100 mg/dL (Phase I)||Week 6 (End of Phase I)|Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I and had at least 1 measurement after the start of study drug provided during Phase I.||Percentage of Participants|||Number
821529|NCT01154036|Secondary|Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) (Phase II).|LDL-C levels measured at Baseline (Week 6; end of Phase 1) and after 6 weeks of study drug administration (Week 12). Baseline was defined as the average of the values at Visits 5 and 6. LDL-C was calculated using the Friedewald method when triglyceride (TG)<350 mg/dL (3.95 mmol/L) and beta quantification ultracentrifugation when TG ≥350 mg/dL (3.95 mmol/L).|Baseline (Week 6) and Week 12|Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II or had at least 1 measurement after the start of Phase II||Percentage Change||Standard Deviation|Median
821530|NCT01154036|Primary|Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) (Phase I)|LDL-C levels measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4. LDL-C was calculated using the Friedewald method when triglyceride (TG)<350 mg/dL (3.95 mmol/L) and beta quantification ultracentrifugation when TG≥350 mg/dL (3.95 mmol/L).|Baseline and Week 6 (end of Phase I )|Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participant who received at least one dose of study drug during Phase I and had a baseline or at least one measurement available during Phase I||Percentage Change||Standard Deviation|Median
821531|NCT01154127|Secondary|Exercise Endurance Time During a Sub-maximal Constant-load Cycle Ergometry Test (SMETT) on Treatment Day 1|"SMETT is an exercise procedure where the patient cycles at 80% of the maximum workload (Wmax )value achieved at the Incremental exercise test. During this test, the patient will cycle at a constant load. Exercise endurance time was from commencement of loaded pedaling to stopping exercise.
The analysis-of covariance model included the sequence, period, and treatment as fixed factors, the baseline value as covariate and the patient as a random effect."|Day 1|Pharmacodynamics (PD) set consisted of participants who completed at least one treatment period, had an evaluable PD assessment on Day 21 of this period and had no major protocol deviation impacting the primary PD assessment.||Seconds||95% Confidence Interval|Least Squares Mean
821532|NCT01154127|Secondary|Leg Discomfort (Borg CR10 Scale) During Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks Treatment|"The modified Borg CR10 Scale consists of 12-point score that the patients pointed to so as to indicate their level of leg discomfort before and during exercise testing (where 0 indicates no breathlessness at all and 12 indicates maximum breathlessness).
A reduction in this score indicates an improvement. The analysis-of covariance model included the sequence, period, and treatment as fixed factors, the baseline value as covariate and the patient as a random effect."|Day 21|Pharmacodynamics (PD) set consisted of participants who completed at least one treatment period, had an evaluable PD assessment on Day 21 of this period and had no major protocol deviation impacting the primary PD assessment.||units on a scale||95% Confidence Interval|Least Squares Mean
821533|NCT01154127|Secondary|Exertional Dyspnea (Borg CR10 Scale) During Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks Treatment|"The Borg CR10 Scale consists of 12-point score that the patients pointed to so as to indicate their level of dyspnea before and during exercise testing (where 0 indicates no breathlessness at all and 12 indicates maximum breathlessness).
A reduction in this score indicates an improvement. The analysis-of covariance model included the sequence, period, and treatment as fixed factors, the baseline value as covariate and the patient as a random effect."|Day 21|Pharmacodynamics (PD) set consisted of participants who completed at least one treatment period, had an evaluable PD assessment on Day 21 of this period and had no major protocol deviation impacting the primary PD assessment.||units on a scale||95% Confidence Interval|Least Squares Mean
821534|NCT01154127|Secondary|Specific Airways Conductance (SGaw)|"SGaw is a measure of how hard it is to get air into the lungs, measured by (Sec(-1)*kP). Whole body plethysmography (Bodybox) was used to measure SGaw.
The analysis-of covariance model included the sequence, period, and treatment as fixed factors, the baseline value as covariate and the patient as a random effect."|Day 21|Pharmacodynamics (PD) set consisted of participants who completed at least one treatment period, had an evaluable PD assessment on Day 21 of this period and had no major protocol deviation impacting the primary PD assessment.||litres/(Second*kpa); kpa = kilopascal||95% Confidence Interval|Least Squares Mean
821535|NCT01154127|Secondary|Slow Vital Capacity (SVC) and Total Lung Capacity (TLC)|"Vital Capacity is the amount of air that can be forcibly exhaled from the lungs after a full inhalation. Slow Vital Capacity (SVC) test is performed by having the patient slowly and completely blow out all of the air from their lungs.
Total Lung Capacity (TLC) is the best vital capacity plus residual volume. Whole body plethysmography (Bodybox) was used to measure SVC and TLC. The trough effects of Day 1 treatment are derived from values prior to morning dosing on the next treatment day (Day 2 of the corresponding period)."|Day 21|Pharmacodynamics (PD) set consisted of participants who completed at least one treatment period, had an evaluable PD assessment on Day 21 of this period and had no major protocol deviation impacting the primary PD assessment. “n” indicates number of participants with observation at each time-point.||Litres||95% Confidence Interval|Least Squares Mean
821536|NCT01154127|Secondary|Peak and Trough (24 h Post Dose) Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC)|"FEV1 is the amount of air that can be exhaled in one second. FEV1 was measured with spirometry conducted according to internationally accepted standards.
FVC is the volume of air that can forcibly be blown out after full inspiration and is used in spirometry tests.
The trough effects of Day 1 treatment are derived from values prior to morning dosing on the next treatment day (Day 2 of the corresponding period).
The analysis-of covariance model included the sequence, period, and treatment as fixed factors, the baseline value as covariate and the patient as a random effect."|Day 21|Pharmacodynamics (PD) set consisted of participants who completed at least one treatment period, had an evaluable PD assessment on Day 21 of this period and had no major protocol deviation impacting the primary PD assessment.||Litres||95% Confidence Interval|Least Squares Mean
821537|NCT01154127|Secondary|Inspiratory Capacity (IC) at Rest (1 Hour Post Dose) and at Peak (End of Exercise) During Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks of Treatment|"IC at peak was observed using spirometry. However, two different methodologies (whole body plethysmography (Bodybox) and spirometry) were used to observe IC at rest.
The analysis of covariance model included the sequence, period, and treatment as fixed factors, the baseline value as covariate and the patient as a random effect."|Day 21|Pharmacodynamics (PD) set consisted of participants who completed at least one treatment period, had an evaluable PD assessment on Day 21 of this period and had no major protocol deviation impacting the primary PD assessment. “n” indicates number of participants with observation at each time-point.||Litres||95% Confidence Interval|Least Squares Mean
821538|NCT01154127|Secondary|Isotime Inspiratory Capacity (IC) During Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks of Treatment|Isotime is the last matching timepoint in the submaximal exercise tolerance test (SMETT) at which for both periods the patient has a test result. The analysis-of covariance model included the sequence, period, and treatment as fixed factors, the baseline value as covariate and the patient as a random effect.|Day 21|Pharmacodynamics (PD) set consisted of participants who completed at least one treatment period, had an evaluable PD assessment on Day 21 of this period and had no major protocol deviation impacting primary the PD assessment.||Liters||95% Confidence Interval|Least Squares Mean
821539|NCT01154127|Primary|Exercise Endurance Time During a Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks (Day 21) of Treatment|SMETT is an exercise procedure where the patient cycles at 80% of the maximum workload (Wmax )value achieved at the Incremental exercise test. During this test, the patient will cycle at a constant load. Exercise endurance time was from commencement of loaded pedaling to stopping exercise. The analysis-of covariance model included the sequence, period, and treatment as fixed factors, the baseline value as covariate and the patient as a random effect.|Day 21|Pharmacodynamics (PD) set consisted of participants who completed at least one treatment period, had an evaluable PD assessment on Day 21 of this period and had no major protocol deviation impacting the primary PD assessment.||seconds||95% Confidence Interval|Least Squares Mean
821540|NCT01154140|Secondary|Percentage of Participants With Hospital Admissions-Healthcare Resource Utilization (HCRU)|Hospitalization details were evaluated in this study. Data regard to hospitalizations were summarized from information in the case report forms.|From 28 days prior to the start of study treatment and up to 28 days post the last dose of study treatment|FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization.||Percentage of participants|||Number
821541|NCT01154140|Secondary|Change From Baseline in General Health Status as Assessed by EuroQol 5D (EQ-5D)- Visual Analog Scale (VAS)|The EQ-5D is a validated and reliable self-report preference-based measure developed by the EuroQoL Group to assess health-related quality of life. It consists of the EQ-5D descriptive system and a visual analogue scale-the EQ VAS. The EQ-5D descriptive system measures a participants' health state on 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels, reflecting “no health problems,” “moderate health problems,” and “extreme health problems.” The EQ VAS records the respondent’s self-rated health on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state).|From Baseline up to treatment withdrawal or crossover|PRO evaluable population included all participants from the FA population who completed a baseline (last PRO assessment prior to randomization day) and at least 1 postbaseline PRO assessment prior to crossover or end of randomized study treatment. N = Total participants in PRO evaluable population set for EQ-5D analysis||Units on a scale||95% Confidence Interval|Mean
821542|NCT01154140|Secondary|Change From Baseline in Lung Cancer Symptom Scores as Assessed by the EORTC Quality of Life Questionnaire-Lung Cancer 13 (QLQ- LC13)|The QLQ-LC13 consisted of 1 multi-item scale and 9 single items that assessed the specific symptoms (dyspnea, cough, hemoptysis, and site specific pain), side effects (sore mouth, dysphagia, neuropathy, and alopecia), and pain medication use of lung cancer patients receiving chemotherapy. Scale score range: 0 to 100. Higher symptom score = greater degree of symptom severity.|Cycle 1 day 1 to end of treatment or withdrawal or crossover|PRO evaluable population included all participants from the FA population who completed a baseline (last PRO assessment prior to randomization day) and at least 1 postbaseline PRO assessment prior to crossover or end of randomized study treatment. N = Total participants in PRO evaluable population set for EORTC QLQ-LC13 analysis.||Units on a scale||95% Confidence Interval|Mean
821543|NCT01154140|Secondary|Change From Baseline Scores in QLQ-C30 Symptoms as Assessed by the EORTC-QLQ-C30|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms.|Cycle 1 day 1 to end of treatment or withdrawal or crossover|PRO evaluable population included all participants from the FA population who completed a baseline (last PRO assessment prior to randomization day) and at least 1 postbaseline PRO assessment prior to crossover or end of randomized study treatment. N = Total participants in PRO evaluable population set for EORTC QLQ-C30 analysis.||Units on a scale||95% Confidence Interval|Mean
821544|NCT01154140|Secondary|Change From Baseline in Functioning and Global Quality of Life (QOL) as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms.|Cycle 1 day 1 to end of treatment or withdrawal or crossover|PRO evaluable population included all participants from the FA population who completed a baseline (last PRO assessment prior to randomization day) and at least 1 postbaseline PRO assessment prior to crossover or end of randomized study treatment. N = Total participants in PRO evaluable population set for EORTC QLQ-C30 analysis.||Units on a scale||95% Confidence Interval|Mean
821545|NCT01154140|Secondary|Time to Deterioration (TTD) in Pain in Chest, Dyspnea, or Cough|TTD in pain in chest, dyspnea, or cough from the Quality of Life Questionnaire Core 30 (QLQ-LC13) was a composite endpoint defined as the time from randomization to the earliest time the participant’s scale scores showed a 10 point or greater increase after baseline in any of the 3 symptoms. For those who had not shown deterioration, the data was censored at the last date when the participants completed an assessment (QLQ-LC13) for pain, dyspnea, or cough or at last visit date prior to crossover for participants randomized to chemotherapy who subsequently crossed over to crizotinib. A 10-point or higher change in the score was perceived by participants as clinically significant. The median TTD mentioned in below table was based on Brookmeyer and Crowley method.|From Baseline to deterioration while on study treatment|The Patient reported outcome (PRO) evaluable population included all participants from the FA population who completed a baseline (last PRO assessment prior to randomization day) and at least 1 postbaseline PRO assessment prior to crossover or end of randomized study treatment.||Months||95% Confidence Interval|Median
821546|NCT01154140|Secondary|ORR Between ALK Variant Groups Based on IRR|A mandatory tumor sample (archived or fresh) was required at screening for detecting ALK gene fusion events in order to determine the eligibility of participants to enter the study. The Vysis ALK Break Apart Fluorescence In Situ Hybridization (FISH) test was used as the primary assay. Only those participants whose tissue sample was positive for the ALK gene fusion by FISH testing by the central laboratory were allowed to enter the study. Testing for ALK gene fusion variants was performed using the Response Genetics, Inc. Echinoderm Microtubule Associated Protein Like 4 (EML4) ALK reverse transcriptase polymerase chain reaction (RT PCR) gene fusion test. Percentage of participant with complete or partial response was according to RECIST version 1.1 by type of ALK gene fusion variant.|Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)|The ALK gene fusion variant evaluable population was defined as participants from the FA population who had a result from ALK gene fusion variant testing of either no rearrangement, or 1 of 9 results reflecting 8 specific rearrangements (V1, V2, V3a, V3b, V3a/b, V4, V5a, V6, and V7).||Percentage of participants||95% Confidence Interval|Number
821547|NCT01154140|Secondary|Percentage of Participants for Each Anaplastic Lymphoma Kinase (ALK) Gene Fusion Variants|A mandatory tumor sample (archived or fresh) was required at screening for detecting ALK gene fusion events in order to determine the eligibility of participants to enter the study. The Vysis ALK Break Apart Fluorescence In Situ Hybridization (FISH) test was used as the primary assay. Only those participants whose tissue sample was positive for the ALK gene fusion by FISH testing by the central laboratory were allowed to enter the study. Testing for ALK gene fusion variants was performed using the Response Genetics, Inc. Echinoderm Microtubule Associated Protein Like 4 (EML4) ALK reverse transcriptase polymerase chain reaction (RT PCR) gene fusion test.|Screening|The ALK gene fusion variant evaluable population was defined as participants from the FA population who had a result from ALK gene fusion variant testing of either no rearrangement, or 1 of 9 results reflecting 8 specific rearrangements (V1, V2, V3a, V3b, V3a/b, V4, V5a, V6, and V7).||Percentage of participants with variant|||Number
821548|NCT01154140|Secondary|Plasma Predose Concentration (Trough Concentration [Ctrough]) of Crizotinib and Its Metabolite|This analysis was performed in crizotinib arm only. Plasma samples for pharmacokinetic (PK) assessment were to be obtained prior to (predose) and around the time to maximum plasma concentration (Tmax) following morning dosing (at 2 to 6 hours postdose until Protocol Amendment 6 which changed the timing of PK sampling to 3 and 5 hours postdose) on Day 1 of Cycles 2, 3, and 5.|Cycle 2 Day 1, Cycle 3 Day 1 and Cycle 5 Day 1|The PK concentration population (also referred to as the PK evaluable population) included any participant in the SA population who had at least 1 plasma concentration of crizotinib or its metabolite, PF 06260182, determined following crizotinib treatment as of the data cutoff date.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
821549|NCT01154140|Secondary|Percentage of Participants With Treatment-emergent AEs (Treatment Related)|An AE was any untoward medical occurrence attributed to study treatment in a participant who received study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs were to be collected from first dose until 28 days after the last dose of study medication. SAEs could be collected after this timeframe if considered to be treatment related. Grade 3 and 4 AEs in the below table indicated severe AE and life-threatening consequences respectively; Grade 5 indicated death related to AE. Chemotherapy group in the below table, only includes data before crossover to crizotinib for those participants who crossed over to receive crizotinib treatment.|From the first dose of study medication until 28 days after the last dose of study medication. However all AEs entered in the database from the treatment start were included in AE analyses.|SA population included all randomized subjects who received at least 1 dose of study treatment, with treatment assignments designated according to actual study treatment received during the first cycle.||Percentage of participants|||Number
821550|NCT01154140|Secondary|Percentage of Participants With Treatment-emergent Adverse Events (AEs; All Causalities)|An AE was an untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes: death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, congenital anomaly. Treatment-emergent AEs were those with initial onset or that worsen in severity after the first dose of study medication. AEs were to be collected from first dose until 28 days after the last dose of study medication. SAEs could be collected after this timeframe if considered to be treatment related. Grade 3 and 4 AEs in below table indicated severe AE and life-threatening consequences respectively; Grade 5 indicated death due to AE. Chemotherapy group in the below table includes data before crossover to crizotinib for participants who crossed over to receive crizotinib.|From the first dose of study medication until 28 days after the last dose of study medication. However all AEs entered in the database from the treatment start were included in AE analyses|The safety analysis (SA) population included all randomized participants who received at least 1 dose of study treatment, with treatment assignments designated according to actual study treatment received during the first cycle.||Percentage of participants|||Number
822143|NCT01160822|Secondary|Time to Reach the Maximum Observed Plasma Concentration of Canakinumab (Tmax)||Day 1, pre-dose and 1, 3, 6 and 8 hours post-dose (Part A only), Day 2, 4, 8, 15, 29, 57, 85 and 126.|Pharmacokinetic analysis set where data were available.||hours||Full Range|Median
821551|NCT01154140|Secondary|Time to Extracranial Progression (EC-TTP) Based on IRR|EC-TTP was defined similarly to TTP, but only considering extracranial disease (excluding intracranial disease) and the progression was determined based on either new extracranial lesions or progression of existing extracranial lesions. The median EC-TTP presented in below table was based on Brookmeyer and Crowley method.|Randomization to objective extracranial progression or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)|FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization.||Months||95% Confidence Interval|Median
821552|NCT01154140|Secondary|Time to Intracranial Progression (IC-TTP) Based on IRR|IC-TTP was defined similarly to TTP, but only considering intracranial disease (excluding extracranial disease) and the progression was determined based on either new brain metastases or progression of existing brain metastases. The median IC-TTP presented in below table was based on Brookmeyer and Crowley method.|Randomization to objective intracranial progression or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)|FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization.||Months||95% Confidence Interval|Median
821553|NCT01154140|Secondary|Time to Progression (TTP) Based on IRR|TTP was defined as the time from the date of randomization to the date of the first documentation of objective tumor progression, as determined by IRR. If tumor progression data included more than 1 date, the first date was used. TTP (in months) was calculated as (first event date − randomization date +1)/30.44. The median TTP presented in below table was based on Brookmeyer and Crowley method,|Randomization to objective progression or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)|FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization.||Months||95% Confidence Interval|Median
821554|NCT01154140|Secondary|Percentage of Participants With Disease Control at Week 12 Based on IRR|Disease Control Rate (DCR) at 12 weeks is defined as the percent of participants with CR, PR or stable disease (SD) at 12 weeks according to RECIST version 1.1 as determined by the IRR. The best response of SD can be assigned if SD criteria were met at least once after randomization at a minimum interval of 6 weeks. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions and disappearance of all non-target lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.|From randomization to Week 12|FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization.||Percentage of participants||95% Confidence Interval|Number
821555|NCT01154140|Secondary|Time to Tumor Response (TTR) Based on IRR|TTR was defined as the time from randomization to first documentation of objective tumor response (CR or PR) as determined by the IRR. For participants proceeding from PR to CR, the onset of PR was taken as the onset of response. TTR was calculated for the subgroup of participants with objective tumor response.|Randomization to first documentation of objective tumor response (up to 35 months)|FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization. N=Participants who had objective tumor response by IRR.||Weeks||Full Range|Median
821556|NCT01154140|Secondary|Duration of Response (DR) Based on IRR|DR was defined as the time from the first documentation of objective tumor response (CR or PR), as determined by the IRR, to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. DR (in weeks) was calculated as (first date of PD or death − first date of CR or PR +1)/7. DR was only calculated for the subgroup of participants with an objective tumor response. The median duration of response presented in below table was based on Brookmeyer and Crowley method.|From objective response to date of progression, death or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months).|FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization. N = Participants with objective tumor response by IRR.||Weeks||95% Confidence Interval|Median
821557|NCT01154140|Secondary|Objective Response Rate - Percentage of Participants With Objective Response as Assessed by IRR|Percentage of participants with objective response of complete response (CR) or partial response (PR) according to RECIST version 1.1. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions and disappearance of all non-target lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.|Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)|FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization.||Percentage of participants||95% Confidence Interval|Number
821558|NCT01154140|Secondary|OS Probability at Months 12 and 18|OS was defined as the time from randomization to the date of death due to any cause. OS (in months) was calculated as (date of death − date of randomization +1)/30.44.|Months 12 and 18|FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization.||Percent probability||95% Confidence Interval|Number
821559|NCT01154140|Secondary|Overall Survival (OS)|OS was defined as the time from randomization to the date of death due to any cause. OS (in months) was calculated as (date of death − date of randomization +1)/30.44.|From randomization to death or last date known alive for those not known to have died (up to 35 months)|FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization.||Months||95% Confidence Interval|Median
822109|NCT01160614|Primary|Single- and Multiple-dose PK Metric: Maximum Observed Plasma Concentration From Hour 0 to 12 Hours of the First Dose of ORF (Cmax 0-12)||Up to 12 hours|The full analysis population for PK (N = 30) was defined as patients who received at least 1 dose of oral study drug and had at least 1 valid quantifiable PK metric||ng/mL||Standard Deviation|Mean
821560|NCT01154140|Primary|Progression-Free Survival (PFS) Based on Independent Radiology Review (IRR) by Treatment Arm|PFS was defined as the time from the date of randomization to the date of the first documentation of objective tumor progression (by IRR) or death on study due to any cause, whichever occured first. If tumor progression data included more than 1 date, the first date was used. PFS (in months) was calculated as (first event date − randomization date +1)/30.44.|Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)|The Full Analysis (FA) population included all participants who were randomized with study treatment assignment designated according to the initial randomization.||Months||95% Confidence Interval|Median
821561|NCT01154153|Secondary|The Percent of Days of Rescue Medication Use During the Double-blind Treatment Phase|The percent of days of rescue medication used during the double-blind treatment phase was calculated. For participants who did not use any rescue medication, the percentage of days using rescue medication was set to be 0.|From randomization to 43-50 days postrandomization|The per protocol (PP) population included all randomized participants who took at least one dose of study medication and had no major protocol violations. Major protocol violations were those deemed most likely to affect the interpretation of the results and included poor compliance, use of prohibited medication, missing blood samples.||Percentage of days||Standard Deviation|Mean
821562|NCT01154153|Secondary|Number of Participants Using Rescue Medication|The number of participants using the rescue medication (Claritin®) during the single-blind screening phase (the time from 8-24 days before randomization up to the day before randomization) and during the double-blind treatment phase (the time from randomization to end of study).|From 8 to 24 days prerandomization and randomization to end of study (43-50 days postrandomization)|The per protocol (PP) population included all randomized participants who took at least one dose of study medication and had no major protocol violations. Major protocol violations were those deemed most likely to affect the interpretation of the results and included poor compliance, use of prohibited medication, missing blood samples.||Participants|||Number
821563|NCT01154153|Secondary|Number of Participants by Relief Level as Evaluated by the Participant|Efficacy of treatment was assessed by the participant using a scale from 0-4 for relief levels, where 0 = no relief (symptoms unchanged or worsened than before), 1 = slight relief (symptoms present and only minimally improved), 2 = moderate relief (symptoms are present and may be troublesome, but are noticeably improved), 3 = marked relief (symptoms are greatly improved and although present are scarcely troublesome) and 4 = complete relief (virtually no symptom present).|At end of study (43-50 days after randomization)|The per protocol (PP) population included all randomized participants who took at least one dose of study medication and had no major protocol violations. Major protocol violations were those deemed most likely to affect the interpretation of the results and included poor compliance, use of prohibited medication, missing blood samples.||Participants|||Number
821564|NCT01154153|Secondary|Number of Participants by Relief Level as Evaluated by the Physician|Efficacy of treatment was assessed by the physician using a scale from 0-4 for relief levels, where 0 = no relief (symptoms unchanged or worsened than before), 1 = slight relief (symptoms present and only minimally improved), 2 = moderate relief (symptoms are present and may be troublesome, but are noticeably improved), 3 = marked relief (symptoms are greatly improved and although present are scarcely troublesome) and 4 = complete relief (virtually no symptom present).|At end of study (43-50 days after randomization)|The per protocol (PP) population included all randomized participants who took at least one dose of study medication and had no major protocol violations. Major protocol violations were those deemed most likely to affect the interpretation of the results and included poor compliance, use of prohibited medication, missing blood samples.||Participants|||Number
821565|NCT01154153|Secondary|Change From Baseline in the Reflective Total Nasal Symptom Score (rTNSS)|"Every morning, participants rated the severity of symptoms experienced over the previous 24 hours using scale from 0-3, where 0=symptoms absent, 1=mild, 2=moderate, and 3=severe symptoms (interfere with daily living or sleep) for each symptom (nasal congestion, nasal itching, sneezing, and runny nose). The rTNSS was the sum of the individual symptom scores, ranged from 0-12 (where 12 reflected the worst symptoms).
Change from baseline in the rTNSS = mean rTNSS (double-blind treatment phase) - mean rTNSS (screening phase)."|From 8-24 days prerandomization up to 6 weeks postrandomization|The per protocol (PP) population included all randomized participants who took at least one dose of study medication and had no major protocol violations. Major protocol violations were those deemed most likely to affect the interpretation of the results and included poor compliance, use of prohibited medication, missing blood samples.||Score on a scale||Standard Deviation|Mean
821566|NCT01154153|Primary|Ratio of Serum Cortisol Area Under Curve [AUC(0-24 hr)] at the End of Treatment to Baseline|"Blood samples were collected over a 24-hour period (at 0, 2, 4, 8, 12, 20, and 24 hours), with 0 hour being between 8:00AM to 9:00AM, immediately prior to investigational product (IP) administration. AUC (0-24hr) was calculated using the trapezoid rule, and was normalized by dividing the AUC(0-24 hr) by the actual sample collection interval between 0-hour and 24-hour blood draw times.
Ratio in Serum Cortisol AUC(0-24 hr) = (Serum Cortisol AUC[0-24 hr] at 6 weeks postrandomization)/(Serum Cortisol AUC[0-24 hr] at 1-3 days prerandomization). Log transformation was used for the analysis."|1-3 days prerandomization and 6 weeks postrandomization|The per protocol (PP) population included all randomized participants who took at least one dose of study medication and had no major protocol violations. Major protocol violations were those deemed most likely to affect the interpretation of the results and included poor compliance, use of prohibited medication, missing blood samples.||Ratio||Full Range|Geometric Mean
821567|NCT01154166|Secondary|Time to Reinstatement of L-dopa Following a Reduction in Dose Using LOCF|The mean number of days after which the dose of L-dopa was readministered after the reduction in dose was recorded.|Baseline to Week 24|ITT Population. Only those participants who had their dose of L-dopa reduced were included in this analysis. Data were collected using the LOCF method.||days||Standard Deviation|Mean
821590|NCT01154218|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞])|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hours (hrs) post crizotinib dose|Pharmacokinetic (PK) parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng*hr/mL||Standard Deviation|Geometric Mean
821568|NCT01154166|Secondary|Mean Change From Baseline in the Parkinson's Disease Quality of Life Scores (PDQ39) Using LOCF|The PDQ39 is a 39 item self-administered questionnaire. The questionnaire covers eight domains of health that are reported as adversely affected by patients with PD. Participants were asked to rate responses on a scale from 0 to 4 (“never” to “always”). The overall index score is the mean of the eight individual domain scores measured on a continuous scale ranging from 0 (no problem at all) to 100 (maximum level of the problem). Change from Baseline is calculated as the value at Week 24 minus the Baseline value.|Baseline and Week 24|ITT Population. Only those participants contributing data at the indicated time points for the indicated domain were analyzed. Data were collected using the LOCF method.||scores on a scale||Standard Deviation|Mean
821569|NCT01154166|Secondary|Mean Change From Baseline (BL) in the Parkinson's Disease Sleep Scale (PDSS) Total Score Using LOCF|The PDSS uses a series of 15 questions to assess sleep disturbance associated with PD. Participants completed the assessments based on their experiences in the past week by marking a cross on each 10 centimeter (cm) scale (labelled from worst to best state). Responses were quantified by measuring the distance along each line where the cross was placed. The scores for each item ranged from 0 (symptom severe and always experienced) to 10 (symptom free). The maximum cumulative score for the PDSS was thus 150 (free of all symptoms). Change from BL=value at Week 24 minus the BL value.|Baseline and Week 24|ITT Population. Only those participants contributing data at the indicated time points were analyzed. Data were collected using the LOCF method.||scores on a scale||Standard Deviation|Mean
821570|NCT01154166|Secondary|Mean Change From Baseline in the Depression Scores on the Hamilton Depression Rating Scale (HAMD-17) Using LOCF|The HAMD-17 is a 17-item scale that is completed by the investigator. Each item was evaluated and scored using either a 5-point scale (e.g., absent, mild, moderate, severe, very severe) or a 3-point scale (e.g., absent, mild, marked). The total HAMD-17 score (sum of the scores of all 17 items) may range from 0 (least severe) to 52 (most severe). Change from Baseline is calculated as the value at Week 24 minus the Baseline value.|Baseline and Week 24|ITT Population. Only those participants contributing data at the indicated time points were analyzed. Data were collected using the LOCF method.||scores on a scale||Standard Deviation|Mean
821571|NCT01154166|Secondary|Number of Responders to Study Treatment Using LOCF|"The off state is defined as the state in which PD symptoms (lack of mobility, tremor, or rigidity) are not adequately controlled by the drug. Responders are defined as participants who had at least a 20% reduction from Baseline in awake time spent off and at least a 20% reduction from Baseline in the L-dopa dose."|Baseline to Week 24|ITT Population. Only those participants contributing data at the indicated time points were analyzed. Data were collected using the LOCF method.||participants|||Number
821572|NCT01154166|Secondary|Number of Participants Requiring Reinstatement of L-dopa Following a Dose Reduction Using LOCF|In the event of unacceptable side effects relative to Baseline (e.g., dyskinesias, dystonias [neurological movement disorder]) the dosage of L-dopa was reduced. If there was reduction in the side effects and there was loss of symptom control, the dose of study medication was again increased (reinstated) at subsequent visits. If symptoms could still not be controlled, then L-dopa was reinstated; however, the dose could not exceed the baseline dose.|Week 24|ITT Population. Only those participants who had their dose of L-dopa reduced were included in this analysis. Data were collected using the LOCF method.||participants|||Number
821573|NCT01154166|Secondary|Number of Responders Based on the Clinical Global Impression (CGI) Global Improvement Scale Using LOCF|The CGI global improvement scale allows the investigator to rate the participant’s total improvement since the beginning of treatment (Baseline). Scores on the scale range from 1 to 7 (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse). Participants with a CGI global improvement score of <=2 (representing much improved or very much improved) were considered to be responders.|Week 24|ITT Population. Only those participants contributing data at the indicated time points were analyzed. Data were collected using the LOCF method.||participants|||Number
821574|NCT01154166|Secondary|Mean Change From Baseline in the UPDRS Activities of Daily Living (ADL) Score at Week 24 Using LOCF|The UPDRS assesses six features of PD impairment, including Activities of Daily Living (ADL). The total ADL score ranges from 0 to 52, where 0= normal/no symptoms and 52= worst possible case. Change from Baseline is calculated as the value at Week 24 minus the Baseline value.|Baseline and Week 24|ITT Population. Only those participants contributing data at the indicated time points were analyzed. Data were collected using the LOCF method.||scores on a scale||Standard Deviation|Mean
821575|NCT01154166|Secondary|Mean Change From Baseline in Total Awake Time “on” Without Troublesome Dyskinesias (TD) at Week 24 Using LOCF|Dyskinesias are involuntary twisting, turning movements caused by medication during “on” time in PD. TD is defined as those movements that interfere with function and cause meaningful discomfort. Participants were asked to record the number of awake hours spent ”on” without TD in 24-hour diary cards prior to each visit on the same two days of each relevant week. The total number of awake hours spent“on”without TD per 24-hour period was the sum of the hours recorded on the two 24-hour diary cards. Change from Baseline is calculated as the value at Week 24 minus the Baseline value.|Baseline and Week 24|ITT Population. Data were collected using the LOCF method.||hours||Standard Deviation|Mean
821576|NCT01154166|Secondary|Mean Change From Baseline in Total Awake Time Spent “on” at Week 24 Using LOCF|"The on state is defined as the state in which the PD symptoms (lack of mobility, tremor, or rigidity) are adequately controlled by the drug. Participants were asked to record the duration of their “on” periods in 24-hour diary cards prior to each visit on the same two days of each relevant week. The total number of awake hours spent “on” per 24-hour period was the sum of the hours recorded on the two 24-hour diary cards. Change from Baseline is calculated as the value at Week 24 minus the Baseline value."|Baseline and Week 24|ITT Population. Data were collected using the LOCF method.||hours||Standard Deviation|Mean
821577|NCT01154166|Secondary|Mean Change From Baseline in the Percentage of Awake Time Spent “Off” (ATSO) at Week 24 Using LOCF|"The off state is defined as the state in which PD symptoms (lack of mobility, tremor, or rigidity) are not adequately controlled by the drug. Participants were asked to record the duration of their “off” periods in 24-hour diary cards prior to each visit on the same 2 days of each relevant week. The total number of awake hours spent “off” per 24-hour period was the sum of the hours recorded on the two 24-hour diary cards. The percentage of ATSO=ATSO divided by (ATSO + awake time spent on) * 100. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline."|Baseline and Week 24|ITT Population. Data were collected using the LOCF method.||Percentage of time||Standard Deviation|Mean
821578|NCT01154166|Secondary|Mean Change From Baseline (BL) in the Unified Parkinson Disease Rating Scale (UPDRS) Total Motor Score at Week 24 Using LOCF|The UPDRS, a clinician-based rating scale, assesses 6 features of PD impairment: (1) mentation, behavior, and mood; (2) activities of daily living; (3) motor examination; (4) complications of therapy; (5) modified Hoehn and Yahr stage; (6) Schwab and England activities of daily living scale. Assessments were conducted when participants had benefit in regard to mobility, tremor, and rigidity. The total motor score (sum of motor examination) ranges from 0 to 108: 0=normal/no symptoms; 108=worst possible case. Change from BL was calculated as the value at Week 24 minus the value at BL.|Baseline and Week 24 (Visit 13)|ITT Population. Only those participants contributing data at the indicated time points were analyzed. Data were collected using the LOCF method.||scores on a scale||Standard Deviation|Mean
821579|NCT01154166|Primary|"Mean Change From Baseline in Total Awake Time Spent Off at Week 24 Using Last Observation Carried Forward (LOCF)"|"The off state is defined as the state in which Parkinson’s Disease (PD) symptoms (lack of mobility, tremor, or rigidity) are not adequately controlled by the drug. Participants were asked to record the duration of their “off ” periods in 24-hour diary cards prior to each visit on two days of each relevant week. The total number of awake hours spent “off” per 24-hour period was the sum of the hours recorded on the two 24-hour diary cards. Change from Baseline is calculated as the value at Week 24 minus the Baseline value."|Baseline and Week 24 (Visit 13)|Intent-to-treat (ITT) Population: all randomized participants who received at least one dose of study medication and for whom at least one post-baseline efficacy assessment was available. In the LOCF dataset, the last available on-therapy observation for a participant is used to estimate missing data points.||hours||Standard Deviation|Mean
821580|NCT01154218|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) for Crizotinib Metabolite (PF-06260182)||0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||hr||Full Range|Median
821581|NCT01154218|Secondary|Maximum Observed Plasma Concentration (Cmax) for Crizotinib Metabolite (PF-06260182)||0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng/mL||Standard Deviation|Geometric Mean
821582|NCT01154218|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞]) for Crizotinib Metabolite (PF-06260182)|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Here, the 'N = 35' is signifying those participants who were evaluable for this measure at the specified time point for crizotinib CIC fed arm group.||ng*hr/mL||Standard Deviation|Geometric Mean
821583|NCT01154218|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Crizotinib Metabolite (PF-06260182)|Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast) of Crizotinib metabolite (PF-06260182).|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng*hr/mL||Standard Deviation|Geometric Mean
821584|NCT01154218|Secondary|Apparent Volume of Distribution (Vz/F)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||L||Standard Deviation|Geometric Mean
821585|NCT01154218|Secondary|Apparent Oral Clearance (CL/F)|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||L/hr||Standard Deviation|Geometric Mean
821586|NCT01154218|Primary|Maximum Observed Plasma Concentration (Cmax)||0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng/mL||Standard Deviation|Geometric Mean
821587|NCT01154218|Secondary|Plasma Decay Half Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||hr||Standard Deviation|Mean
821588|NCT01154218|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||hr||Full Range|Median
821589|NCT01154218|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast).|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng*hr/mL||Standard Deviation|Geometric Mean
821891|NCT01156701|Secondary|Number of Patients With Asthma|The frequency of asthma among the four cohorts was measured.|2006-2009|The study population consisted of individuals who were at least 5 years old and had been continuously enrolled for at least 6 months in the Normative Health Informatics (NHI) insurance claims database during the influenza seasons of 2006-2009 (October-April).||patients|||Number
821591|NCT01154231|Secondary|Subjective Evaluation of Each Therapeutic Administration for Bleeding Episodes|Propotion of subjects whose physicians evaluated the effect of BeneFIX for bleeding episodes as excellent or good was calculated.|2 years for PTPs, 1 year for PUPs|Efficacy analysis set who recieved at least one administration and had at least one efficacy evaluation was used for this analysis.||percentage|evaluations by physicians|95% Confidence Interval|Number
821592|NCT01154231|Primary|Number of Administrations Required for Hemostasis for Bleeding Events|Mean number of administrations for hemostasis in replacement therapy for bleeding events.|2 years for PTPs, 1 year for PUPs|Efficacy analysis set who recieved at least one administration and had at least one efficacy evaluation was used for this analysis.||administrations|dosing for hemostasis|Full Range|Mean
821593|NCT01154231|Primary|Number of Bleeding Episodes (Annual Bleeding Event Rate) During Periodic Replacement Therapy|Annual bleeding rate (ABR) was calculated as the number of total bleeding events occured during prophylaxis period devided by the period (events/year). ABR for other replacement treatment period was also calculated to evaluate the differences between types of treatment. If the period used for ABR calculation was less or equal than 7 days, the relevant data was regarded as missing.|2 years for PTPs, 1 year for PUPs|Efficacy analysis set who recieved at least one administration and had at least one efficacy evaluation was used for this analysis.||Bleeding events/year||Inter-Quartile Range|Median
821594|NCT01154283|Secondary|EuroQol Visual Analogue Scale(VAS)|Quality of life assessed with visual analogue scale. Where the patient is asked to place a mark on a piece of paper with a vertical, scale from 100 at the top to 0 at the bottom of the scale. Where the patient is informed that 100 represents his or her best imaginable health state and 0 is his or her worst imaginable health state.|Assessed at 6 weeks (first intervention) and 12 weeks (second intervention)|One patient died and unable to report quality of life at end of 12 weeks. Two additional patients completed 12 weeks study but did not complete quality of life assessments.||units on a scale||Standard Deviation|Mean
821595|NCT01154283|Secondary|Transitional Dyspnea Index|Transitional Dyspnea Index scores patient reported changes in difficulty breathing during each intervention period from -3 (major deterioration) to +3 (major improvement) in three categories: functional impairment, magnitude of task, and magnitude of effort. The total TDI score ranges from -9 to +9.|Assessed at 6 weeks (first intervention) and 12 weeks (second intervention)|One patient died and unable to report dyspnea at end of 12 weeks. Two additional patients completed 12 weeks study but did not complete dyspnea assessments.||units on a scale||Standard Deviation|Mean
821596|NCT01154283|Secondary|"Patient Preference (Likert Scale) Definitely IPAP-only Probably IPAP-only Uncertain Probably Bi-level Definitely Bi-level"|"Patient Preference of NIPPV mode:
definitely IPAP-only probably IPAP-only uncertain probably Bi-level definitely Bi-level Number of patients who chose definitely or probably are reported."|Assessed at 6 weeks (first intervention) and 12 weeks (second intervention)|One patient died before completion of 12 weeks (second intervention) and could not have patient preference assessed.||participants|||Number
821597|NCT01154283|Primary|Hours of NIPPV Usage|Patients experienced the first intervention period during weeks 1-6 and the second intervention period during weeks 7-12. Patients were given one week to learn how to use the NIPPV equipment at the beginning of each intervention period. Therefore, only the total NIPPV hours used during the last 5 weeks of each intervention period were collected and divided by the number of weeks to obtain the average, weekly hours of NIPPV usage assessed at 6 weeks (first intervention) and 12 weeks (second intervention) for each patient.|Assessed at 6 weeks (first intervention) and 12 weeks (second intervention)|||hours||Full Range|Mean
821598|NCT01154296|Secondary|Sexual Risk Behavior -- # of Sex Acts With Substance Use|Self-reported continuous variables to determine number of (vaginal and/or anal) sex acts in which the participant reported using substances before the sex act.|6 months post randomization|||sex acts with substance use|||Number
821599|NCT01154296|Secondary|Sexual Risk Behavior -- # of Unprotected Partners|Self-reported continuous variables to determine number of partners with whom the participant had unprotected (vaginal and/or anal) sex.|6 months post randomization|||unprotected partners||Standard Error|Least Squares Mean
821600|NCT01154296|Secondary|Sexual Risk Behavior -- # of Partners|Self-reported continuous variables to determine number of partners with whom the participant had (vaginal and/or anal) sex.|6 months post randomization|||partners||Standard Error|Least Squares Mean
821601|NCT01154296|Secondary|Sexual Risk Behavior -- # of Unprotected Sex Acts|Self-reported continuous variables to determine number of unprotected (vaginal and/or anal) sex acts|6 months post randomization|||unprotected sex acts||Standard Error|Least Squares Mean
821602|NCT01154296|Secondary|Sexual Risk Behavior -- # of Sex Acts|Self-reported continuous variables to determine number of (vaginal and/or anal) sex acts.|6 months post randomization|||sex acts||Standard Error|Least Squares Mean
821603|NCT01154296|Primary|STI Incidence|Composite STI incidence (Yes/No) at 6-month follow-up in which a person is considered positive for STIs if they are positive on any tested STI.|6 months post randomization|||participants|||Number
821604|NCT01154322|Primary|Apnea-Hypopnea Index (AHI) Using the New Pediatric Mask (Pixi) Compared to the Child's Currently-used Mask|Apnea-Hypopnea index (AHI) is an average of the number of apneas and hypopneas that occur over an hour of recorded sleep. AHI quantifies the severity of sleep disordered breathing (SDB). The higher the AHI, the more severe the SDB (mild 5-15, moderate 15-30, severe >30). In clinical practice an AHI <5 demonstrates efficacy of treatment. AHI was recorded during a monitored sleep study on the new Pixi mask and compared with the AHI from a monitored sleep study on the child's usual mask. The outcome hypothesis was that the Pixi mask AHI would be equivalent or reduced compared to the child's usual mask.|AHI after min 21 days use with Pixi mask|||AHI (events/hour)||Standard Deviation|Mean
821605|NCT01154322|Primary|Apnea-hypopnea Index (AHI) Using the New Pediatric Mask (Pixi) Compared to the Child's Currently-used Mask|Apnea-Hypopnea index (AHI) is an average of the number of apneas and hypopneas that occur over an hour of recorded sleep. AHI quantifies the severity of sleep disordered breathing (SDB). The higher the AHI, the more severe the SDB (mild 5-15, moderate 15-30, severe >30). In clinical practice an AHI <5 demonstrates efficacy of treatment. AHI was recorded during a monitored sleep study on the new Pixi mask, and compared with the AHI from a monitored sleep study on the child's usual mask. The outcome hypothesis was that the Pixi mask AHI would be equivalent or reduced compared to the child's usual mask.|Baseline AHI|Subjects who completed all visits and procedures||AHI (events/hour)||Standard Deviation|Mean
821606|NCT01154335|Secondary|Response Rate|Response rate (RR) will be estimated as the proportion of patients exhibiting complete response or partial response out of all evaluable cases. Complete Response is defined per RECIST as disappearance of all target/non-target lesions and normalization of tumor markers. Partial Response is defined per RECIST as At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|18 months|Only patients who received at least 8 weeks of treatment were considered evaluable for response and were included in the response rate analysis||participants|||Number
821607|NCT01154335|Secondary|Overall Survival (OS)|Overall survival (OS) is defined as the time between Day 1 Cycle 1 to the date of death from any cause. Those remaining alive will be censored at their last known assessment or follow-up.|18 months|||weeks||95% Confidence Interval|Median
821608|NCT01154335|Secondary|Progression-Free Survival (PFS)|Progression-free survival (PFS) is defined as the time between Day 1 Cycle 1 and date of first documented recurrence or death. Patients who do not exhibit progression while on trial will be censored at their last known assessment. Progression is defined per RECIST criteria as either 1) at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest (nadir) sum since the treatment started, or the appearance of one or more new lesions. Requires not only 20% increase, but absolute increase of a minimum of 5 mm over sum. OR 2) Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|18 Months|||weeks||95% Confidence Interval|Median
821609|NCT01154335|Primary|To Determine the Maximum Tolerated Dose (MTD) of the Combination of OSI-906 and Everolimus for the Treatment of Patients With Refractory Metastatic Colorectal Cancer.||18 Months|||milligrams|||Number
821610|NCT01154452|Secondary|Response Rate (CR + PR) as Assessed by RECIST 1.1 (Phase Ib and II)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions|Up to 4 months|||participants|||Number
821611|NCT01154452|Primary|Progression-free Survival (PFS) of the Combination of RO4929097 With and Without GDC-0449 in Patients With Advanced Sarcoma. (Phase II)|Progression-free survival (PFS) of the combination of RO4929097 with and without GDC-0449 in patients with advanced sarcoma. (Phase II)|1 year||||||
821612|NCT01154452|Primary|Maximum-tolerated Dose of Gamma-secretase Inhibitor RO4929097, Defined as the Dose Level Where no More Than 1 Out of 6 Patients Experience DLT at the Highest Dose Level Below the MAD, Graded According to NCI-CTCAE Version 4.0 (Phase Ib)||Up to 28 days|||mg|||Number
821613|NCT01154634|Secondary|Clinically Relevant Change of Laboratory Variables|Number of participants with clinically relevant change of laboratory variables as judged by the responsible medical officer.|Pre-entry to follow-up|||Participants|||Number
821614|NCT01154634|Secondary|Terminal Half-life (T Half)|Terminal half-life (T half)|0 to 12 hours post dose|"Data from one subject in arm AZD2516 5 mg were excluded from efficacy analysis due to incorrect medication received.
Two samples were not analyzed for T half due to technical reasons."||hours||95% Confidence Interval|Geometric Mean
821615|NCT01154634|Secondary|Time to Maximum Plasma Concentration (Tmax)|Time to maximum plasma concentration (Tmax)|0 to 12 hours post dose|Data from one subject in arm AZD2516 5 mg were excluded from efficacy analysis due to incorrect medication received.||hours||Full Range|Median
821616|NCT01154634|Secondary|Maximum Plasma Concentration (Cmax)|Maximum plasma concentration|0 to 12 hours post dose|Data from one subject in arm AZD2516 5 mg were excluded from efficacy analysis due to incorrect medication received.||nmol/L||95% Confidence Interval|Geometric Mean
821617|NCT01154634|Secondary|Average Plasma Concentration (C Average)|Average plasma concentration|1 to 4 hours post dose|Data from one subject in arm AZD2516 5 mg were excluded from efficacy analysis due to incorrect medication received.||nmol/L||95% Confidence Interval|Geometric Mean
821618|NCT01154634|Secondary|Area Under the Plasma Concentration Curve(AUC)|Area under the plasma concentration vs. time curve from time zero to 12-hours post dose calculated by loglinear trapezoidal method|0 to 12 hours post dose|Data from one subject in arm AZD2516 5 mg were excluded from efficacy analysis due to incorrect medication received.||nmol*h/L||95% Confidence Interval|Geometric Mean
821619|NCT01154634|Secondary|Transient Lower Esophagus Sphincter Relaxations (TLESRs) 0 to 3 Hours Post Meal|Number of TLESRs 0 to 3 hours post meal were calculated based upon the manometric analysis fpr the 3-hour post-meal period.|0 to 3 hours post meal|Data from two subjects were excluded from efficacy analysis due to incorrect medication received Data from five visits from two subject were excluded form analysis due to deviations caused by technical problems.||relaxations||Full Range|Geometric Mean
821620|NCT01154634|Primary|Reflux Episodes 0 to 3 Hours Post Meal|Total number of reflux episodes 0 to 3 hours post meal|0 to 3 hours post meal|Data from two subjects (one in arm AZD2516 5 mg, and one in arm Placebo) were excluded from efficacy analysis due to incorrect medication received.||Episodes||Full Range|Geometric Mean
821621|NCT01154673|Primary|Change in Proviral HIV-1 DNA in Total CD4+ T-cells From Baseline to Week 48 in Participants Randomized to the Intensified Arm Versus the Control Arm Who Received Placebo in Addition to Standard HAART.|The level of HIV Provirus in CD4 T cells obtained from peripheral blood at 48 weeks compared to baseline. A quantitative HIV PCR assay was done. The mean/median values from the standard HAART group is compared to the intensive HAART treatment regimen.|Baseline to Week 48|||HIV DNA copies/ million CD4 cells||Full Range|Median
821622|NCT01154699|Secondary|FEV1 %Predicted|Performed as part of spirometry|Every 4 weeks during the 12 week study (at the start and end of the usual care period, and at the start and end of the Bilevel PAP intervention period)|All subjects completed both arms of this crossover study.||percentage of predicted FEV1||Standard Deviation|Mean
821623|NCT01154699|Secondary|Short Form (SF-36) Health Survey|Well validated quality of life questionnaire that measures eight sub-sections, which are summed to yield a score from 0 (maximal disability) to 100 (no disability). The eight subsections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health.|Every 4 weeks during the 12 week study (at the start and end of the usual care period, and at the start and end of the Bilevel PAP intervention period)|All subjects completed both arms of the study||units on a scale||Standard Deviation|Mean
822144|NCT01160822|Secondary|Maximum Observed Plasma Concentration of Canakinumab (Cmax)||Day 1, pre-dose and 1, 3, 6 and 8 hours post-dose (Part A only), Day 2, 4, 8, 15, 29, 57, 85 and 126.|Pharmacokinetic analysis set where data were available.||µg/mL||Standard Deviation|Mean
821624|NCT01154699|Secondary|Pittsburgh Sleep Quality Index (PSQI)|Well validated questionnaire used frequently to measure sleep quality over the prior 1 month. It consists of 19 individual items that combine to form 7 components summed to create one global score. The overall score is between 0 (better sleep) and 21 (worse sleep).|Every 4 weeks during the 12 week study (at the start and end of the usual care period, and at the start and end of the Bilevel PAP intervention period)|All subjects completed both arms of this crossover study.||units on a scale||Standard Deviation|Mean
821625|NCT01154699|Secondary|Epworth Sleepiness Scale (ESS)|8 item questionnaire to measure daytime sleepiness, with total score reported 0 (less sleepy) to 24 (most sleepy). Scores greater than or equal to 10 are considered excessive daytime sleepiness.|Every 4 weeks during the 12 week study (at the start and end of the usual care period, and at the start and end of the Bilevel PAP intervention period)|All subjects completed both arms of this crossover study.||units on a scale||Standard Deviation|Mean
821626|NCT01154699|Primary|Airway Reactivity as Measured by Methacholine Challenge (PC20)|This is a physiological measurement derived from repeated breathing maneuvers which measures airway reactivity. Subjects are exposed to higher and higher concentrations of an airway irritant (in this case methacholine), and between each dose perform spirometry. The test is stopped after the forced expiratory volume in 1 second (FEV1) falls 20% below the baseline. The concentration of methacholine at which this occurs is called the PC20. Methacholine challenges are routinely used in the diagnosis of asthma, and in many asthma research studies to measure changes in airway reactivity.|Every 4 weeks during the 12 week study (at the start and end of the usual care period, and at the start and end of the Bilevel PAP intervention period)|All subjects completed the crossover study design||mg/mL||Standard Error|Geometric Mean
821627|NCT01154699|Primary|Asthma Control Test|Well validated questionnaire of asthma symptoms which includes 5 written questions. Each question is answered on a scale of 1-5, which are summed to report a range of asthma control from 5 to 25 (higher score indicates better asthma control).|Every 4 weeks during the 12 week study (at the start and end of the Usual Care period, and at the start and end of the Bilevel PAP intervention period)|All 21 patients went through usual care and bilevel PAP therapy||units on a scale||Standard Deviation|Mean
821628|NCT01154751|Secondary|Six-minute Walking Distance|The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication.|2 Years|The number of patients analyzed is based on the data available.||Meters||Standard Deviation|Mean
821629|NCT01154751|Secondary|Target Limb Ankle Brachial Index (at Rest)|"Ankle Brachial Index (ABI) is a measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms. A doppler probe is used to monitor the pulse while a sphygmomanometer is inflated above the artery. The cuff is deflated and the pressure at which the pulse returns is recorded.
ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure
The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease."|2 Years|The number of patients analyzed is based on the data available.||Ratio||Standard Deviation|Mean
821630|NCT01154751|Secondary|Target Limb Ankle Brachial Index (at Rest)|"Ankle Brachial Index (ABI) is a measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms. A doppler probe is used to monitor the pulse while a sphygmomanometer is inflated above the artery. The cuff is deflated and the pressure at which the pulse returns is recorded.
ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure
The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease."|1 Year|The number of patients analyzed is based on the data available.||Ratio||Standard Deviation|Mean
821631|NCT01154751|Secondary|Target Limb Ankle Brachial Index (at Rest)|"Ankle Brachial Index (ABI) is a measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms. A doppler probe is used to monitor the pulse while a sphygmomanometer is inflated above the artery. The cuff is deflated and the pressure at which the pulse returns is recorded.
ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure
The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease."|6 months|The number of patients analyzed is based on the data available.||Ratio||Standard Deviation|Mean
821632|NCT01154751|Secondary|Target Limb Ankle Brachial Index (at Rest)|"Ankle Brachial Index (ABI) is a measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms. A doppler probe is used to monitor the pulse while a sphygmomanometer is inflated above the artery. The cuff is deflated and the pressure at which the pulse returns is recorded.
ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure
The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease."|30 days|The number of patients analyzed is based on the data available.||Ratio||Standard Deviation|Mean
821633|NCT01154751|Secondary|Target Limb Ankle Brachial Index (at Rest)|"Ankle Brachial Index (ABI) is a measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms. A doppler probe is used to monitor the pulse while a sphygmomanometer is inflated above the artery. The cuff is deflated and the pressure at which the pulse returns is recorded.
ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure
The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease."|At baseline|The number of patients analyzed is based on the data available.||Ratio||Standard Deviation|Mean
821634|NCT01154751|Secondary|Stent Fracture|"Stent fracture and Involuntary stent migration are types of device System Failure.
Device System Failure is defined as the inability of the device to provide the intended clinical utility requiring surgical intervention to correct."|1 to 3 Years|The number of patients analyzed is based on the data available.||participants|||Number
821635|NCT01154751|Secondary|Stent Fracture|"Stent fracture and Involuntary stent migration are types of device System Failure.
Device System Failure is defined as the inability of the device to provide the intended clinical utility requiring surgical intervention to correct."|1 to 2 years|The number of patients analyzed is based on the data available.||participants|||Number
821636|NCT01154751|Secondary|Stent Fracture|Stent fractures determined by fluoroscopy .|1 Year|The number of patients analyzed is based on the data available.||participants|||Number
821637|NCT01154751|Secondary|Target Lesion Revascularization|"Target Vessel: The entire vessel in which the treated lesion is located. The boundaries for the iliac artery are the abdominal aortic bifurcation and the superior border of the inguinal ligament.
Target Lesion Revascularization (TLR): Any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion.)"|1 Year|The number of patients analyzed is based on the data available.||percentage of participants|||Number
821638|NCT01154751|Secondary|Target Lesion Revascularization|Target Lesion Revascularization (TLR): Any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).|6 months|The number of patients analyzed is based on the data available.||percentage of participants|||Number
821639|NCT01154751|Secondary|Restenosis by Duplex Ultrasound|In-Stent Restenosis is re-narrowing within the margins of the stent following the reduction of a previous narrowing. It is defined as the presence of a hemodynamically significant restenosis (≥ 50%), as determined by duplex ultrasonography (DUS) or arteriography. A peak systolic velocity ratio (PSVR) of 2.4 and 2.5 will be used to calculate duplex restenosis.|1 Year|"If no PSVR measurement was available, patient was excluded from restenosis analysis. If patient had TLR prior to duplex ultrasound, PSVR was excluded from restenosis analysis.
The number of patients analyzed is based on the data available."||percentage of participants|||Number
821640|NCT01154751|Secondary|Restenosis by Duplex Ultrasound|In-Stent Restenosis is re-narrowing within the margins of the stent following the reduction of a previous narrowing. It is defined as the presence of a hemodynamically significant restenosis (≥ 50%), as determined by duplex ultrasonography (DUS) or arteriography. A peak systolic velocity ratio (PSVR) of 2.4 and 2.5 will be used to calculate duplex restenosis.|6 months|"If no PSVR measurement was available, patient was excluded from restenosis analysis. If patient had TLR prior to duplex ultrasound, PSVR was excluded from restenosis analysis.
The number of patients analyzed is based on the data available."||percentage of participants|||Number
821641|NCT01154751|Secondary|Rutherford-Becker Clinical Category|"Rutherford/Becker Categories:
0 - Asymptomatic, no hemodynamically significant occlusive disease.
- Mild claudication.
- Moderate claudication.
- Severe claudication.
- Ischemic rest pain.
- Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia.
- Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable."|30 days|The number of patients analyzed is based on the data available.||percentage of participants|||Number
821642|NCT01154751|Secondary|Number of Peri-procedural and Post-procedural Complications|Periprocedural/Postprocedural Complications defined as complications during the procedure through 30 days post implant that include hematoma, arteriovenous (AV) fistula pseudoaneurysm, subacute occlusion, non-target lesion Percutaneous Transluminal Angioplasty (PTA) /stenting, distal embolization, and vessel perforation.|30 days|||Number of compilcations|||Number
821643|NCT01154751|Secondary|Number of Participants Experiencing Peri-procedural and Post-procedural Complications|Periprocedural/Postprocedural Complications defined as complications during the procedure through 30 days post implant that include hematoma, arteriovenous (AV) fistula pseudoaneurysm, subacute occlusion, non-target lesion Percutaneous Transluminal Angioplasty (PTA) /stenting, distal embolization, and vessel perforation.|30 days|||Participants|||Count of Participants
821644|NCT01154751|Primary|Six-minute Walking Distance|The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication.|1 Year|The number of patients analyzed is based on the data available.||Meters||Standard Deviation|Mean
821645|NCT01154751|Primary|Six-minute Walking Distance|The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication.|6 months|The number of patients analyzed is based on the data available.||Meters||Standard Deviation|Mean
821646|NCT01154751|Primary|Six-minute Walking Distance|The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication.|30 days|The number of patients analyzed is based on the data available.||Meters||Standard Deviation|Mean
821647|NCT01154751|Primary|Six-minute Walking Distance|The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication.|At baseline|The number of patients analyzed is based on the data available.||Meters||Standard Deviation|Mean
821656|NCT01154985|Primary|Alanine Transaminase (ALT) Levels|"Mean change from baseline at month 6 analyzed by Analysis of Covariance (ANCOVA) in the efficacy analysis set with treatment group as a factor and baseline ALT as a covariate. Principal comparisons were the response between;
EPA-E 2700 mg and Placebo groups
EPA-E 1800 mg and Placebo groups"|6 months|Efficacy Evaluable Analysis Set - All patients in Full Analysis Set who have valid 12-month histological data without major protocol violations, including withdrawn patients with valid 12.5 month histological data after more than 6 months treatment||U/L||Standard Deviation|Mean
821657|NCT01154985|Primary|Alanine Transaminase (ALT) Levels|"Mean change from baseline at month 3 analyzed by Analysis of Covariance (ANCOVA) in the efficacy evaluable analysis set with treatment group as a factor and baseline ALT as a covariate. Principal comparisons were the response between;
EPA-E 2700 mg and Placebo groups
EPA-E 1800 mg and Placebo groups"|3 month endpoint|Efficacy Evaluable Analysis Set - All patients in Full Analysis Set who have valid 12-month histological data without major protocol violations, including withdrawn patients with valid 12.5 month histological data after more than 6 months treatment||U/L||Standard Error|Least Squares Mean
821658|NCT01154985|Primary|Histological Response Defined by Change From Baseline in Standardized Scoring of Liver Biopsies|"Patient is considered a responder if histological examination shows:
Composite NAS of <=3 AND no worsening in Fibrosis OR Improvement in NAS by >=2 across at least 2 of the NAS components AND no worsening in fibrosis
A priori threshold for statistical significance is p<0.05, 1-sided"|12 months|Efficacy Evaluable Analysis Set - All patients in Full Analysis Set who have valid 12-month histological data without major protocol violations, including withdrawn patients with valid 12.5 month histological data after more than 6 months treatment||participants|||Number
821659|NCT01155011|Primary|Minutes of Light to Moderate Physical Activity|Measured by 7 day accelerometry in adults, ≥65, using a 760 CPM cutpoint.|12 months|||minutes||Standard Deviation|Mean
821660|NCT01155011|Primary|Daily Minutes of Physical Activity|Measured by 7 day accelerometry in adults, ≥65, with a 760 CPM cutpoint.|6 months|||minutes||Standard Deviation|Mean
821661|NCT01155011|Primary|Daily Minutes of Physical Activity|Measured by 7 day accelerometry with a 760 cpm cutpoint.|Baseline|||minutes||Standard Deviation|Mean
821662|NCT01155024|Secondary|Participant Socket Preference After 3 Months Usage of the Direct Manufactured Socket|Number of participants indicating socket preference after 3 months usage of the direct manufactured prosthetic socket. Comparisons made to their previous traditional definitive prosthetic socket|3 months|Total number of participants completing the period (3 months usage of direct manufactured socket) and participants classified as 'Withdrawal by participant'. Analysis does not include participants who prematurely withdrew for reasons unrelated to the direct manufactured socket intervention.||participants|||Number
821663|NCT01155024|Secondary|Participant Socket Preference After Initial Fitting|Number of participants indicating socket preference after initial fitting of both socket interventions|Within the first 4-6 hours|Total number of participants completing period for both study interventions.||participants|||Number
821664|NCT01155024|Primary|Hanspal Socket Comfort Score (SCS) After Initial Socket Fitting|The Hanspal SCS assesses participant socket comfort on a continuous scale from 0 (most uncomfortable) to 10 (most comfortable)|Within the first 4-6 hrs|Per protocol analysis including all consented participants||score on scale||Standard Deviation|Mean
821665|NCT01155063|Secondary|Percentage of Participants With Recurrent Disease|Percentage of participants with confirmed recurrent disease at the end of the study (recurrence was defined as loco-regional and/or contralateral and/or distance metastases).|Month 36 or early withdrawal|Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study.|||||
821669|NCT01155063|Secondary|Number of Participants With Concomitant Medications|Concomitant medication (any medication other than, and in addition to, the study medication) taken for any period of time during the study and was coded by World Health Organization (WHO) medical dictionary.|Month 0 up to Month 36 or early withdrawal|Safety analysis set included participants who received at least one dose of the study medication during the observation period.||Participants|||Number
821670|NCT01155063|Secondary|Number of Participants With Concomitant Morbidities|Participants who had a concomitant morbidity during the study for any period of time; participants with more than one concomitant morbidity were counted for each of the concomitant morbidity classes applicable.|Month 0 up to Month 36 or early withdrawal|Safety analysis set included participants who received at least one dose of the study medication during the observation period.||Participants|||Number
821671|NCT01155063|Primary|Number of Participants With Adverse Events (AEs)|An AE was any untoward medical occurrence attributed to study medication in a participant who received study medication.|Month 0 up to Month 36 or early withdrawal|Safety analysis set included participants who received at least one dose of the study medication during the observation period.||Participants|||Number
821672|NCT01148017|Secondary|Number of Subjects Reporting Unsolicited AEs and SAEs|Number of subjects reporting unsolicited AEs, serious adverse events (SAEs) and medically attended AEs after receiving study vaccination.|Day 1 to 7 after vaccination for any unsolicited AEs, day 1 to study termination for SAEs and medically attended AEs (for the naive-40 group), day 8 to study termination for SAEs and medically attended AEs (for the other groups).|Analysis was done on the Post MenACWY at 60 months safety set ie, all subjects who received a vaccination at 60 months and were assessed for postvaccination safety, and on the Post MenACWY at 40 Months Safety Set, ie, the Naive subjects enrolled at 40 months of age who received vaccination at 40 months and were assessed for post vaccination safety.||Number of subjects|||Number
821673|NCT01148017|Secondary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity|"Number of subjects reporting solicited local and systemic Adverse Events (AEs) and other indicators of reactogenicity after receiving study vaccination.
Note: solicited AEs were not recorded for naive subjects at 40 months of age, but only SAEs and medically attended AEs."|From day 1 to 7 after vaccination.|Analysis was done on the Solicited Safety Set (from 6 hours to day 7), ie, all subjects who received a vaccination at 60 months and provided postvaccination solicited safety data.||Subjects|||Number
821674|NCT01148017|Secondary|Percentage of Subjects With Seroresponse at 1 Month Post-vaccination|"The antibody response to one booster dose of MenACWY-CRM in children of 60 months of age who had previously received at least one dose of MenACWY-CRM in the parent study, compared to the antibody response to one dose of MenACWY-CRM in meningococcal vaccine-naïve subjects, is measured by the percentage of subjects with seroresponse at 1 month post-vaccination.
Seroresponse is defined as hSBA ≥ 1:8 for subjects with pre-vaccination hSBA titer ≤1:4, and as at least a four-fold rise in hSBA for subjects with pre-vaccination hSBA titer ≥ 1:4."|Visit 11, 1 month after vaccination.|Analysis was done on the PPS Post-MenACWY-CRM.||Percentage of subjects||95% Confidence Interval|Number
821675|NCT01148017|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:8, and ≥ 1:4 Directed Against N. Meningitidis Serogroups A, C, W-135, and Y, at 1 Month Post-vaccination|The antibody response to one booster dose of MenACWY-CRM in children of 60 months of age who had previously received at least one dose of MenACWY-CRM in the parent study compared to the antibody response to one dose of MenACWY-CRM in meningococcal vaccine-naïve subjects, is measured by the percentage of subjects with hSBA titers ≥ 1:8 and ≥1:4 directed against N. meningitidis serogroups A, C, W-135, and Y, at 1 month post-vaccination.|Visit 11, 1 month after vaccination.|Analysis was done on the PPS-Immunogenicity after one dose of MenACWY-CRM (PPS Post-MenACWY-CRM), ie, all subjects in the enrolled population who correctly received the vaccine, provided at least one evaluable serum sample at the relevant time points and whose assay result was available for at least one serogroup with no major protocol deviation.||Percentages of subjects||95% Confidence Interval|Number
821676|NCT01148017|Secondary|hSBA GMTs Directed Against N Meningitidis Serogroups A, C, W-135, and Y in Subjects of 60 Months of Age|The persistence of the antibody response in children of 60 months of age previously vaccinated with MenACWY-CRM in study V59P14 (NCT00474526), and baseline antibody levels in age-matched naive subjects is measured by the hSBA GMTs directed against N meningitidis serogroups A, C, W-135, and Y.|Visit 10, 60 months of age.|Analysis was done on the PPS 60-Month persistence.||Titers||95% Confidence Interval|Geometric Mean
821677|NCT01148017|Secondary|hSBA Geometric Mean Titers (GMTs) Directed Against N. Meningitidis Serogroups A, C, W-135, and Y in Subjects of 40 Months of Age|The persistence of the antibody response in children of 40 months of age previously vaccinated with MenACWY-CRM in study V59P14 (NCT00474526), and baseline antibody levels in age-matched naive subjects, is measured by the hSBA GMTs directed against N meningitidis serogroups A, C, W-135, and Y.|Visit 9 (continuation from the parent study), 40-months of age.|Analysis was done on the PPS 40-month persistence.||Titers||95% Confidence Interval|Geometric Mean
821678|NCT01148017|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:4 Against N Meningitidis Serogroups A, C, W-135, and Y Subjects of 60 Months of Age|The persistence of the antibody response in subjects of 60 months of age previously vaccinated with MenACWY-CRM in the parent study, and baseline antibody levels in age-matched naive subjects, is measured by the percentage of subjects with human Serum Bactericidal Assay (hSBA) titers ≥ 1:4 directed against N. meningitidis serogroups A, C, W-135, and Y.|Visit 10, 60 months of age.|Analysis was done on the PPS 60-Month persistence.||Percentages of subjects||95% Confidence Interval|Number
821679|NCT01148017|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:4 Against N Meningitidis Serogroups A, C, W-135, and Y in Subjects of 40 Months of Age|The persistence of the antibody response in subjects of 40 months of age previously vaccinated with MenACWY-CRM in the parent study, and baseline antibody levels in age-matched naive subjects, is measured by the percentage of subjects with human Serum Bactericidal Assay (hSBA) titers ≥ 1:4 directed against N. meningitidis serogroups A, C, W-135, and Y.|Visit 9, 40 months of age.|Analysis was done on the PPS 40-month persistence.||Percentages of subjects||95% Confidence Interval|Number
821892|NCT01156701|Primary|Number of Patients With Influenza|The frequency of influenza among the four cohorts was measured.|2006-2009|The study population consisted of individuals who were at least 5 years old and had been continuously enrolled for at least 6 months in the Normative Health Informatics (NHI) insurance claims database during the influenza seasons of 2006-2009 (October-April).||patients|||Number
821680|NCT01148017|Primary|Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titers ≥ 1:8 Directed Against N. Meningitidis Serogroups A, C, W-135, and Y|The persistence of the antibody response in subjects of 60 months of age previously vaccinated with MenACWY-CRM in the parent study, and baseline antibody levels in age-matched naive subjects, is measured by the percentages of subjects with human Serum Bactericidal Assay (hSBA) titers ≥ 1:8 directed against N. meningitidis serogroups A, C, W-135, and Y.|Visit 10, 60 months of age|Analysis was done on the Per Protocol Set 60-Month persistence (PPS 60-Month persistence), ie, all subjects in the enrolled population who provided an evaluable serum sample at the 60-month of age visit and had no major protocol deviation.||Percentages of subjects||95% Confidence Interval|Number
821681|NCT01148017|Primary|Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titers ≥ 1:8 Directed Against N. Meningitidis Serogroups A, C, W-135, and Y|The persistence of the antibody response in subjects of 40 months of age, previously vaccinated with MenACWY-CRM in the parent study, and baseline antibody levels in age-matched naive subjects, is measured by the percentage of subjects with human Serum Bactericidal Assay (hSBA) titers ≥ 1:8 directed against N. meningitidis serogroups A, C, W-135, and Y.|Visit 9 (continuation from the parent study), 40-month visit.|Analysis was done on the Per Protocol Set 40-month persistence (PPS 40-month persistence), ie, all subjects in the enrolled population who provided an evaluable serum sample at the 40-months of age visit and had no major protocol deviation.||Percentages of subjects||95% Confidence Interval|Number
821682|NCT01148056|Secondary|Accuracy|To determine the accuracy of advanced MRI imaging and PET (Positron Electron Tomography) /CT in predicting nodal stage.|2 years|Study was closed early due to poor accrual. Analyses not completed.|||||
821683|NCT01148056|Secondary|Quantity of Circulating Tumor Cells|To determine the impact of radiation and surgery on quantity of circulating tumor cells in both metastatic and non-metastatic patients.|2 years|Study was closed early due to poor accrual. Analyses not completed.|||||
821684|NCT01148056|Secondary|Tissue Microarray|To determine changes in the tumor induced by radiation as assessed by tissue microarray.|2 years|Study was closed early due to poor accrual. Analyses not completed.|||||
821685|NCT01148056|Secondary|Surgical Complication Rate|To determine the surgical complication rate in patients who received preoperative radiation therapy.|2 years|Study was closed early due to poor accrual. Analyses not completed.|||||
821686|NCT01148056|Secondary|Pelvic Control Rate|To determine the pelvic control rate of patients after short course radiation therapy and surgery.|2 years|Study was closed early due to poor accrual. Analyses not completed.|||||
821687|NCT01148056|Primary|Bowel Quality of Life|To determine the rate of fecal incontinence at 1 year in patients undergoing an low anterior resection (LAR), as measured by bowel quality of life measure after preoperative conformal radiation therapy delivered in one week for rectal cancer.|2 years|Study was terminated early due to slow accrual. Analysis was not performed.|||||
821688|NCT01148420|Primary|Cessation of Bleeding Within 5 Days|Patients were called within 24 hours and 48 hours following their first study visit to ascertain their bleeding status and their use of medication, as well as any significant side effects they msy have been experiencing. Patients were asked to return to the clinic on day 3 for a repeat hemoglobin and interval history. Those women who were still having any bleeding on day 3 were contacted on day 5|3-5 days|||participants|||Number
821689|NCT01148420|Secondary|Satisfaction and Willingness to Recommend Treatment|Participants were asked whether they would recommend this treatment to a friend|End of the trial; up to day 5|||participants|||Number
821690|NCT01148420|Secondary|Patient Perception of the Acceptability of the Treatment|Results from a survey question that assessed the subjects' satisfaction with the therapy on a scale of 1-3. 1 = poor; 2 = good; 3 = excellent.|End of the trial; up to day 5|||units on a scale||Full Range|Median
821691|NCT01148511|Secondary|Quality of Life|The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) was used to measure a patient’s subjective assessment of vision-related quality of life at Visits 2, 6, 9, 12, and 15. The 12 subscales in the VFQ-25 are general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. The scores on the subscales were added together for a total score, which ranged from 0 to 100. A higher score indicated poorer function.|Visits 2, 6, 9, 12, and 15 (up to 12 months)|Per protocol population: All patients who were evaluated at Baseline and at 12±2 months. Patients who discontinued from the study were not included in the per protocol population.||Units on a scale||Full Range|Median
821692|NCT01148511|Secondary|Change in Central Retinal Thickness From Baseline to Month 12|Retinal thickness was measured using Optical Coherence Tomography (OCT).|Baseline to Month 12|Per protocol population: All patients who were evaluated at Baseline and at 12±2 months. Patients who discontinued from the study were not included in the per protocol population.||µm||Full Range|Median
821693|NCT01148511|Secondary|Follow-up Duration|Follow-up duration was defined as the number of days from Baseline to study discontinuation.|Baseline to Month 12|Per protocol population: All patients who were evaluated at Baseline and at 12±2 months. Patients who discontinued from the study were not included in the per protocol population.||Days||Full Range|Mean
821694|NCT01148511|Secondary|Number of Visits||Baseline to Month 12|Per protocol population: All patients who were evaluated at Baseline and at 12±2 months. Patients who discontinued from the study were not included in the per protocol population.||Visits||Full Range|Median
821695|NCT01148511|Secondary|Letter Count From Baseline to Month 12|Letter count was assessed in the study eye. Measurements were made using the logarithm of the minimum angle of resolution (logMAR) visual acuity testing charts. Results are reported in various categories of change in letter count.|Baseline to Month 12|Per protocol population: All patients who were evaluated at Baseline and at 12±2 months. Patients who discontinued from the study were not included in the per protocol population.||Percentage of patients|||Number
821696|NCT01148511|Primary|Change in Letter Count From Baseline to Month 12|Letter count was assessed in the study eye. Measurements were made using the logarithm of the minimum angle of resolution (logMAR) visual acuity testing charts. A higher letter count score indicates better vision. A negative change score indicates improvement.|Baseline to Month 12|Per protocol population: All patients who were evaluated at Baseline and at 12±2 months. Patients who discontinued from the study were not included in the per protocol population.||Letters||Full Range|Median
821697|NCT01148511|Primary|Change in Best-Corrected Visual Acuity (logMAR) From Baseline to Month 12|Best corrected visual acuity (BCVA) was assessed in the study eye. BCVA measurements were made using the logarithm of the minimum angle of resolution (logMAR) visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there are 5 letters per line, the total score for a line on the logMAR chart represents a change of 0.1 log units. The formula for calculating the logMAR BCVA score is: 0.1 + logMAR value of the best line read - 0.02 x number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.|Baseline to Month 12|Per protocol population: All patients who were evaluated at Baseline and at 12±2 months. Patients who discontinued from the study were not included in the per protocol population.||logMAR||Full Range|Median
821698|NCT01148524|Primary|Geometric Mean Concentration Against Meningococcal 287-953 Antigen, At 18 Months After Month-6 Vaccination in V72P10 Study, and in Naive Subjects.|The immune response was measured as the geometric mean concentrations (GMCs) directed against meningococcal 287-953 antigen, evaluated using enzyme-linked immunosorbent assay (ELISA), at 18 months after month-6 vaccination of rMenB+OMV-NZ or placebo in V72P10 study, and in age-matched vaccine naive subjects enrolled in this study.|18 months after last vaccination V72P10 study.|Analysis was performed on the MITT dataset.||UI/mL||95% Confidence Interval|Geometric Mean
821699|NCT01148524|Primary|Geometric Mean Ratio at 18 Months After Month-6 Vaccination, Over Baselines at Month 0 and at One Month After the Last rMenB+OMV-NZ Vaccination in the V72P10 Study.|The immune response was measured as the geometric mean ratio (GMRs) of hSBA GMTs against meningococcal strains 44/76-SL, 5/99 and NZ98/254 as follow: GMTs at 1 month after last vaccination to baseline GMTs; GMTs at 18 months after last vaccination to baselines GMTs; and GMTs at 18 months after last vaccination to GMTs at 1 month after last vaccination.|month 0 (baseline), month 1 and 18 months after last vaccination in V72P10 study.|Analysis was performed on the MITT data set. Naive group was not reported for this endpoint since GMR data for this group were not collected (subjects were enrolled in this study and no GMT values at 1m and 18 m after last vaccination in V72P10 are available).||Geometric mean ratio||95% Confidence Interval|Number
821700|NCT01148524|Primary|Geometric Mean hSBA Titers Directed Against Meningococcal Strains, At 18 Months After Month-6 Vaccination in V72P10 Study, and in Naive Subjects.|The immune response was measured as the hSBA geometric mean titers (GMTs) directed against meningococcal strains 44/76-SL, 5/99 and NZ98/254, at 18 months after month-6 vaccination of rMenB+OMV-NZ or placebo in V72P10 study, and in age-matched vaccine naive subjects enrolled in this study.|month 0 (bl=baseline), month 1 and 18 months after last vaccination in V72P10 study.|Analysis was performed on the MITT data set.Samples were collected at 18 months post last vaccination in the parent study. For the Naive group, blood samples were obtained for meningococcal serology at day 1 and served as a comparator.||Geometric mean titers||95% Confidence Interval|Geometric Mean
821701|NCT01148524|Primary|Percentage of Subjects With hSBA Titers ≥1:4 Against Meningococcal Strains, At 18 Months After Month-6 Vaccination in V72P10 Study, and in Naive Subjects.|The immune response was measured as the percentage of subjects with hSBA titers ≥1:4 against meningococcal strains 44/76-SL, 5/99 and NZ98/254, at 18 months after month-6 vaccination of rMenB+OMV-NZ or placebo in V72P10 study, and in age-matched vaccine naive subjects enrolled in this study, evaluated by serum bactericidal assay using human complement (hSBA).|month 0 (bl=baseline), month 1 and 18 months after last vaccination in V72P10 study.|Analysis was performed on the modified intention-to-treat (MITT) data set, i.e. all subjects who provided evaluable serum samples. Samples were collected at 18 months post last vaccination in the parent study. For the Naive group, blood samples were obtained for meningococcal serology at day 1 and served as a comparator.||Percentage of subjects||95% Confidence Interval|Number
821702|NCT01148537|Secondary|The Average Differences From Baseline Between Moxifloxacin and Placebo by Fridericia’s Corrected Interval (QTcF) on Day 6 and Day 13|"QT and RR data were determined for each of 4 ECGs over an approximate 10-minute interval at each nominal time point. The average QT and QTc (interval corrected for heart rate) data from the replicate ECGs at each nominal time point were calculated. The average QT and QTc data over the 2 pretreatment days were used as the baseline QT and QTc values.
Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected by Fridericia’s method (QTcF) msec."|Baseline to Day 6 and Day 13|"The full analysis population for ECGs (N = 131) was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose digital QT/QTc evaluation.
For the comparison of moxifloxacin to placebo (N = 88), the subjects randomized to BTDS were excluded."||QTcF (msec)||Standard Deviation|Least Squares Mean
821703|NCT01148537|Secondary|The Average Differences From Baseline Between BTDS and Placebo by Fridericia’s Corrected Interval (QTcF) on Day 6 and Day 13|"QT and RR data were determined for each of 4 ECGs over an approximate 10-minute interval at each nominal time point. The average QT and QTc (interval corrected for heart rate) data from the replicate ECGs at each nominal time point were calculated. The average QT and QTc data over the 2 pretreatment days were used as the baseline QT and QTc values.
Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected by Fridericia’s method (QTcF) msec."|Baseline to Day 6 and Day 13|"The full analysis population for ECGs (N = 131) was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose digital QT/QTc evaluation.
For the comparison of BTDS to placebo (N = 88), the subjects randomized to moxifloxacin were excluded."||QTcF (msec)||Standard Deviation|Least Squares Mean
821704|NCT01148537|Secondary|The Average Differences From Baseline Between Moxifloxacin and Placebo of Bazett Corrected QT Interval (QTcB) on Day 6 and Day 13|"QT and RR data were determined for each of 4 ECGs over an approximate 10-minute interval at each nominal time point. The average QT and QTc data from the replicate ECGs at each nominal time point were calculated. The average QT and QTc data over the 2 pretreatment days were used as the baseline QT and QTc values.
Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected by Bazett’s method (QTcB) msec."|Baseline to Day 6 and Day 13|"The full analysis population for ECGs (N = 131) was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose digital QT/QTc evaluation.
For the comparison of moxifloxacin to placebo (N=88), the subjects randomized to BTDS were excluded."||QTcB (msec)||Standard Deviation|Least Squares Mean
822145|NCT01160822|Secondary|Part B: Physician's Global Assessment of Response to Treatment at Week 12|The study physician made a global assessment of response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor.|Week 12|Pharmacodynamic analysis set, where data were available.||participants|||Number
821705|NCT01148537|Secondary|The Average Differences From Baseline Between BTDS and Placebo by Bazett Corrected QT Interval (QTcB) on Day 6 and Day 13|"QT and RR data were determined for each of 4 ECGs over an approximate 10-minute interval at each nominal time point. The average QT and QTc (QT interval corrected for heart rate) data from the replicate ECGs at each nominal time point were calculated. The average QT and QTc data over the 2 pretreatment days were used as the baseline QT and QTc values.
Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected by Bazett’s method (QTcB) msec."|Baseline to Day 6 and Day 13|"The full analysis population for ECGs (N = 131) was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose digital QT/QTc evaluation.
For the comparison of BTDS to placebo (N = 88), the subjects randomized to moxifloxacin were excluded."||QTcB (msec)||Standard Deviation|Least Squares Mean
821706|NCT01148537|Secondary|The Average Differences Between Moxifloxacin vs Placebo From Baseline by Interval Corrected From Within-subject Data (QTci) on Day 6|"QT and RR data were determined for each of 4 ECGs over an approximate 10-minute interval at each nominal time point. The average QT and QTc data from the replicate ECGs at each nominal time point were calculated. The average QT and QTc data over the 2 pretreatment days were used as the baseline QT and QTc values.
Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected from within-subject data (QTci) msec."|Baseline to Day 6|"The full analysis population for ECGs (N = 131) was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose digital QT/QTc evaluation
For the comparison of moxifloxacin to placebo (N = 88), the subjects randomized to BTDS were excluded."||QTci (msec)||Standard Deviation|Least Squares Mean
821707|NCT01148537|Primary|The Comparison of Moxifloxacin to Placebo Transdermal System (TDS): the Average Difference From Baseline Using QT Interval Corrected From Within-subject Data (QTci) on Day 13|"Observed time from start of the QRS complex to end of the T wave (QT), and the time between the 2 R waves (RR) data for each of 4 electrocardiographs (ECGs) over an approximate 10-minute interval at each nominal time point. The average QT and QTc data over the 2 pretreatment days were used as the baseline QT and QTc values.
Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected from within-subject data (QTci) msec."|Baseline to Day 13|"The full analysis population for ECGs (N = 131) was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose digital QT/QTc evaluation.
For the comparison of moxifloxacin to placebo (N=88), the subjects randomized to BTDS were excluded."||QTci (msec)||Standard Deviation|Least Squares Mean
821708|NCT01148537|Secondary|The Average Differences Between BTDS vs Placebo From Baseline by Interval Corrected From Within-subject Data (QTci) on Day 6|"QT and RR data were determined for each of 4 ECGs over an approximate 10-minute interval at each nominal time point. The average QT and QTc data from the replicate ECGs at each nominal time point were calculated. The average QT and QTc data over the 2 pretreatment days were used as the baseline QT and QTc values.
Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected from within-subject data (QTci) msec."|Baseline to Day 6|"The full analysis population for ECGs (N = 131) was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose digital QT/QTc evaluation.
For the comparison of BTDS to placebo (N = 88), the subjects randomized to moxifloxacin were excluded."||QTci (msec)||Standard Deviation|Least Squares Mean
821709|NCT01148537|Primary|The Comparison of BTDS to Placebo Transdermal System (TDS): the Average Difference From Baseline Using QT Corrected From Within-subject Data (QTci) on Day 13|"Observed time from start of the QRS complex to end of the T wave (QT), and the time between the 2 R waves (RR) data for each of 4 electrocardiographs (ECGs) over an approximate 10-minute interval at each nominal time point. The average QT and QTc data over the 2 pretreatment days were used as the baseline.
Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected from within-subject data (QTci) msec."|Baseline to Day 13|"The full analysis population for ECGs (N = 131) was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose digital QT/QTc evaluation.
For the comparison of BTDS to placebo (N = 88), the subjects randomized to moxifloxacin were excluded."||QTci (msec)||Standard Deviation|Least Squares Mean
821710|NCT01148693|Primary|Number of Participants With Cholangitis|After Endoscopic Retrograde CholangioPancreatography (ERCP) in 3 following days we check all participants for syptoms of cholangitis (fever, chills, right upper qudrant (RUQ) pain, leukocytosis) and ruling out other diagnoses than cholangitis|72 hours|||participants|||Number
821711|NCT01148745|Secondary|Serum Ferritin|Serum ferritin values were measured at all visits|7 (visit 5), 14 (visit 8), 21 (visit 11) and 28 days (visit 14)|||g/mL||Full Range|Median
821712|NCT01148745|Secondary|Transferrin Saturation (TSAT)|Transferrin saturation (TSAT) measured as a percentage, is a medical laborastory test. It is the ratio of serum iron and total iron-binding capacity, multiplied by 100|7 (visit 5), 14 (visit 8), 21 (visit 11), and 28 (visit14) days.|||percent||Full Range|Median
821713|NCT01148745|Primary|Number of Weeks Until Transferrin Saturation (TSAT) and Ferritin Stabilize|TSAT,ferritin,and TIBC measured before start of dialysis on dosing days, and on next 13 HD treatments. Continuous variables were summarized using median. Paired continuous data (e.g., TSAT, serum ferritin) were compared using the Wilcoxon signed rank test. Analyses evaluating stabilization of post drug iron indices was determined by comparing consecutive values at consecutive dialysis sessions and when there was no longer a difference between 2 consecutive time points, levels were considered stabilized. P-values <0.05 were considered statistically significant.|pre-dosing/baseline, and 7 (visit 5), 14 (visit 8), 21 (visit 11) and 28 (visit 14) days after drug administration|||weeks|||Number
821714|NCT01148771|Primary|Area Under the Curve From 48 to 72 Hours [AUC(48-72)]|AUC(48-72) is the 24 hour area under the concentration versus time curve after the 3rd dose of ertapenem, which is selected to measure approximate AUC at steady-state.|0-24 hours after 3rd ertapenem dose|||mcg*hr/mL||Standard Deviation|Mean
821715|NCT01148771|Secondary|Probability of Target Attainment (PTA)|After simulating 5000 patients receiving each dosing regimen, the probability of achieving free drug concentrations above an MIC of 0.25 mcg/mL and 0.5mcg/mL for at least 40% of the dosing interval (40% fT>MIC) is calculated at each MIC dilution.|Simulated Steady-State Exposure|The probability of achieving 40% T>MIC is reported at a MIC of 0.25mcg/mL and 0.5mcg/mL respectively.||% of 5000 simulated patients|Participants||Number
821716|NCT01148771|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|The following laboratory assessments will be make before and after participation in the study to determine if objective changes occurred: blood pressure, pulse rate, temperature, complete blood count with differential, platelet count, blood urea nitrogen, serum creatinine, liver function panel [aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase], total bilirubin, and urinalysis with microscopy. Monitoring of other pathologic or unintended changes in structure (signs),or function (symptoms) of the body associated with participation in the study will occur.|3 days|||participants|||Number
821717|NCT01148771|Primary|Maximum Observed Plasma Concentration (Cmax) at Steady-State (After 3rd Dose)|Cmax is measured at 5 minutes after the beginning of the infusion for the 5 minute IV bolus dosage regimen and at 30 minutes after the beginning of the infusion for the 30 minute infusion dosage regimen.|5 or 30 minutes post start of infusion on Day 3|Each participant received ertapenem as a 5 minute infusion and as a 30 minute infusion, only in different order due to cross-over design. Data for all participants receiving each dosage regimen are included in each arm for results.||mcg/mL||Standard Deviation|Mean
821718|NCT01148836|Secondary|Red Blood Cell Distribution Width||before and after three months of CoQ|||percentage of sizes of red blood cells||Standard Deviation|Mean
821719|NCT01148836|Secondary|Mean Corpuscular Hemoglobin||before and after three months of CoQ|||pg||Standard Deviation|Mean
821720|NCT01148836|Secondary|Hematocrit||before and after three months of CoQ|||% of red blood cell||Standard Deviation|Mean
821721|NCT01148836|Secondary|Hemoglobin||before and after three months of CoQ|||g/dl||Standard Deviation|Mean
821722|NCT01148836|Secondary|Red Blood Cells||before and after three months of CoQ|||10^6 cells/µl||Standard Deviation|Mean
821723|NCT01148836|Primary|Right Atrial Pressure||before and after three months of CoQ|Due to financial constraints only PAH subjects had echocardiograms performed before and after Co-Q||mmHg||Standard Deviation|Mean
821724|NCT01148836|Primary|Tricuspid Regurgitation Grade|Tricuspid Regurgitation Grade ranges from 1 (normal) to 4 (severe regurgitation)|before and after three months of CoQ|Due to financial constraints only PAH subjects had echocardiograms performed before and after Co-Q||units on a scale||Standard Deviation|Mean
821725|NCT01148836|Primary|Right Ventricle Myocardial Performance|Tei Index=(IRT+ICT)/ET, where IRT is isovolumic|before and after three months of CoQ|Due to financial constraints only PAH subjects had echocardiograms performed before and after Co-Q||ratio||Standard Deviation|Mean
821726|NCT01148836|Primary|Right Ventricular Outflow|Velocity time interval|before and after three months of CoQ|Due to financial constraints only PAH subjects had echocardiograms performed before and after Co-Q||cm||Standard Deviation|Mean
821727|NCT01148836|Primary|Left Ventricular End Diastolic Volume|Amount of blood in ventricle at end of diastole|before and after three months of CoQ|Due to financial constraints only PAH subjects had echocardiograms performed before and after Co-Q||ml||Standard Deviation|Mean
821728|NCT01148862|Primary|The Primary Treatment Comparison is the Evaluation of the Severity (Milligrams Per Deciliter) of Induced Hypoglycemia.|Severity (Milligrams per Deciliter) of induced hypoglycemia (YSI < 70 Milligrams per Deciliter) is defined as 70 Milligrams per Deciliter minus absolute lowest blood sugar level|approximately 8 hours per induction experiment|||Milligrams per Deciliter||Standard Deviation|Mean
821729|NCT01148862|Primary|The Primary Treatment Comparison is the Evaluation of the Duration (Minutes) of Induced Hypoglycemia.|Duration (minutes) of induced hypoglycemia (YSI < 70 mg/dL)|approximately 8 hours per induction experiment|||minutes||Standard Deviation|Mean
821730|NCT01148979|Primary|Change From Baseline in the Dysphoric Apathy/Retardation Sub-factor (MDAR) of Montgomery-Asberg Depression Rating Scale (MADRS) at 4 Weeks.|The Montgomery-Asberg Depression Rating Scale Dysphoric Apathy Retardation subfactor (MDAR) is a 5-item subscale of the clinician-administered 10-item Montgomery-Asberg Depression Rating Scale (MADRS). MDAR score can range from 0-30 with a higher score representing a greater severity of depressive symptoms.|Baseline to 4 weeks of treatment|All participants who completed all 4 weeks on both treatments (i.e., Placebo and Vyvanse) were included in the analysis.||scores on a scale||Standard Deviation|Mean
821731|NCT01155141|Secondary|Total Cholesterol||Baseline - Month 6|||mg/dL||Standard Deviation|Median
821732|NCT01155141|Secondary|Glucose||Baseline - Month 6|||mg/dL||Standard Deviation|Median
821733|NCT01155141|Secondary|Diastolic Blood Pressure||Baseline - Month 6|||mm Hg||Standard Deviation|Median
821734|NCT01155141|Secondary|Systolic Blood Pressure||Baseline - Month 6|||mm Hg||Standard Deviation|Median
821735|NCT01155141|Secondary|Weight||Baseline - Month 6|||kg||Standard Deviation|Median
821736|NCT01155141|Primary|Protein/Creatinine Ratio||Baseline - Month 6|||unitless||Standard Deviation|Median
821737|NCT01155141|Secondary|eGFR||Baseline - Month 6|||mL/min/1.73m^2||Standard Deviation|Median
821738|NCT01155141|Primary|Serum Creatinine||Baseline - Month 6|||mg/dL||Standard Deviation|Median
821739|NCT01155141|Primary|24 Hour Proteinuria||Baseline - Month 6|||g/day||Standard Deviation|Median
821740|NCT01155154|Primary|Number of Participants With Presence of Wound Infection|Hand lacerations will be examined 10-14 days after initial wound closure and will be assessed for presence of infection.|2 weeks|||participants|||Number
821741|NCT01155167|Secondary|Radial Artery Patency|Prior to discharge, color doppler ultrasound was used at the site where the sheath had been inserted to determine whether the radial artery was patent (open, unobstructed).|24 hours|per protocol||participants|||Number
821742|NCT01155167|Secondary|Radial Artery Spasm During Catheterization|The blinded clinical operator recorded whether radial artery spasm occurred, as detected by resistance to advancing the catheter through the radial artery, by difficulty in torquing the catheter, or by difficulty in removing the catheter.|2 hours|All participants except 3 participants in the Topical Dilator arm for whom RAS data were not recorded||participants|||Number
821743|NCT01155167|Primary|Change in Radial Artery Diameter|The cross-sectional radial artery area was measured using a high frequency linear array transducer. All ultrasound measurements were made 2 cm proximal to the radial styloid process. Each measurement was performed 3 times and averaged. At least 30 minutes after the application of topical creams, the radial artery diameter was again measured in the same fashion.|Baseline and after 30 minutes of drug application|||Percent change||Standard Deviation|Mean
821750|NCT01155323|Primary|Corneal Staining|Investigator assessment of the corneal staining. Staining is an indication of dryness on areas on the cornea. Here it is measured over 5 regions of the cornea: central, temporal, nasal, inferior, and superior. The staining is graded using the National Eye Institute (NEI)0-3 scale: grade 0 = normal, grade 1 = mild, grade 2 = moderate, grade 3 = severe.|after 1 week of lens wear|The analysis population represents subjects that completed the study per protocol.||Units on a scale||Standard Error|Least Squares Mean
821751|NCT01155323|Primary|Subjective Rating of Handling|This outcome is a weighted combined score calculated from individual lens handling-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.|after 1 week of lens wear|The analysis population represents subjects that completed the study per protocol.||Units on a scale||Standard Error|Least Squares Mean
821752|NCT01155323|Primary|Vision Quality|This outcome is a weighted combined score calculated from individual vision-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.|after 1 week of lens wear|The analysis population represents subjects that completed the study per protocol.||Units on a scale||Standard Error|Least Squares Mean
821753|NCT01155323|Primary|Subjective Rating of Comfort|This outcome is a weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.|after 1 week of lens wear|The analysis population represents subjects that completed the study per protocol.||Units on a scale||Standard Error|Least Squares Mean
821754|NCT01155336|Secondary|Cardiac Electrophysiology|A 20-minute supine 12-lead Holter ECG will allow the quantification of a series of standard ECG parameters as well as provide insight into frequency-domain HRV parameters, QRS duration and morphology, using signal-averaged ECG (SAECG), repolarization morphology, and variability utilizing specialized programs.|1 week||||||
821755|NCT01155336|Primary|Platelet Function|Platelet function will be measured with PFA-100 test which has been shown to correlate with an increased risk for cardiovascular events in several well conducted studies and in a meta-analysis. The PFA-100 measures the number of seconds required for a clot to form in whole blood which is passed through an aperture in a cartridge coated with epinephrine. It is meant to imitate clotting in human arteries.|12 hours|We did not complete the study and no subjects were randomized to corn oil||seconds||Full Range|Mean
821756|NCT01155726|Primary|Average Subjective Comfort|"Participants were asked, How would you rate your comfort with your study lenses? and indicated their response by marking a continuum line ranging from 0=very poor comfort to 100=excellent comfort. Subjective comfort was collected at three time points (insertion, 4 hours, 8 hours) for 3 days, and the comfort ratings were averaged together."|Insertion, 4 hours, 8 hours each: Day 1, Day 2, and Day 3|Per protocol||Units on a scale||Standard Deviation|Mean
821757|NCT01155830|Secondary|TNF-alpha, Maximum|This study will quantify inflammatory cytokine profiles in three neonatal disease states, namely, neonatal sepsis with cardiovascular instability, infants with a congenital diaphragmatic hernia defect, and infants suffering cardiopulmonary failure significant enough to require heart/lung bypass treatment with extracorporeal membrane oxygenation (ECMO).|up to 2 weeks|||pg/mL||Standard Error|Mean
821758|NCT01155830|Primary|TNF-alpha, Baseline|This study will quantify inflammatory cytokine profiles in three neonatal disease states, namely, neonatal sepsis with cardiovascular instability, infants with a congenital diaphragmatic hernia defect, and infants suffering cardiopulmonary failure significant enough to require heart/lung bypass treatment with extracorporeal membrane oxygenation (ECMO).|Baseline|||pg/mL||Standard Error|Mean
821759|NCT01155869|Secondary|Treatment Participation|Percentage of total during-treatment study visits attended. This serves as a proxy for the number of months of treatment participation|16 weeks|||percentage of visits|Participants||Number
821760|NCT01155869|Primary|Mean Weekly Self-reported Alcohol Consumption|Mean number of standard drinks per week during the 24 week study. A standard drink is any drink that contains about 14 grams of pure alcohol, e.g. 12 ounces of beer, 5 ounces of wine or 1.5 ounces of spirits.|24 weeks|||standard drink||Standard Deviation|Mean
821761|NCT01155999|Primary|The Primary Efficacy Variable Was Clinical Cure in the Worse Eye on Day 3|Clinical cure was defined as a score 0 for bulbar conjunctival injection (evaluated using a 4 point ordinal scale) and a score 0 for conjunctival purulent discharge (evaluated using a 4 point ordinal scale).|Day 3|The analysis of the primary clinical efficacy variable was primarily performed on the basis of the MFAS. The MFAS consisted of all patients of the FAS with positive Day 0 culture results in an eligible eye.||participants|||Number
821762|NCT01156012|Primary|Change From Baseline in Intraocular Pressure (IOP)|"The worse eye is defined as:
If both eyes are eligible the eye with highest Intraocular pressure (IOP) at Day 0 (D0). If both eyes have the same IOP at D0 the worse eye is the right eye.
If only one eye is eligible this eye is the worse eye.
If neither eye is eligible the worse eye is defined as the eye with the highest IOP at D0.
If both eyes have the same IOP at D0 the worse eye is the right eye."|Day 0 and Day 84|mITT set : All randomised patients, with at least one eligible eye, having received at least one dose of the Investigational Medicinal Product, and for whom any follow-up IOP recording was available for the worse eye.||mmHg||Standard Deviation|Mean
821763|NCT01156051|Secondary|Change in Baseline to Treatment Minutes of Wake Time After Sleep Onset (WASO)|Polysomnographic parameter of sleep assessing how many minutes of wakefulness occurred after sleep onset and before full morning awakening.|Baseline to last observation carried forward (after at least one week of dose stability)|29 children were enrolled; two were disqualified: one (treatment) was lost to follow-up,and one (placebo) was noncompliant with the protocol.||minutes||Standard Deviation|Mean
821764|NCT01156051|Secondary|Change in Baseline to Treatment Latency to Persistent Sleep (LPS)|Change in an objective measure of sleep onset, using polysomnography.|Baseline to last observation carried forward (after at least one week of dose stability)|29 children were enrolled; two were disqualified: one (treatment) was lost to follow-up,and one (placebo) was noncompliant with the protocol.||minutes||Standard Deviation|Mean
821796|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 25|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 25|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
821765|NCT01156051|Secondary|Change in Baseline to Treatment ADHD-Rating Scale IV Total Score|Change in baseline to treatment ADHD-Rating Scale IV (Investigator-interview ) total. This scale quantitates ADHD symptoms based on DSM-IV criteria with a minimum score of 0 and a maximum score of 54 (higher scores suggesting more ADHD symptoms). The total score is a sum of the 9 items on the ADHD Rating Scale IV inattention score and the 9 items on the ADHD Rating Scale IV hyperactivity-impulsivity score (scores for each 0-27).|Baseline to last observation carried forward (after at least one week of dose stability)|29 children enrolled, but two were discontinued before termination data was available: one (treatment) was lost to follow up and one (placebo) was noncompliant with the protocol.||units on a scale||Standard Deviation|Mean
821766|NCT01156051|Primary|Change in Polysomnographic Total Sleep Time (TST)|Change in objective measures of sleep, using polysomnography|Baseline to last observation carried forward (after at least one week of dose stability)|29 children were enrolled, one (treatment) was lost to follow up an one (placebo) was discontinued due to noncompliance with protocol.||minutes||Standard Deviation|Mean
821767|NCT01156116|Secondary|Change From Baseline in 24-hr Diastolic Blood Pressure (mmHg) at Week 2|"The average diastolic blood pressure over a 24-hr period was calculated for each patient.
Change = Week 2 - Baseline"|Baseline and Week 2|Patients were excluded from the analysis if they were missing blood pressure data at both Baseline and Week 2.||mmHg||95% Confidence Interval|Mean
821768|NCT01156116|Secondary|Change From Baseline in 24-hr Systolic Blood Pressure (mmHg) at Week 2|"The average systolic blood pressure measured over a 24-hr period was calculated for each patient.
Change = Week 2 - Baseline."|Baseline and Week 2|Patients were excluded from the analysis if they were missing blood pressure data at both Baseline and Week 2.||mmHg||95% Confidence Interval|Mean
821769|NCT01156116|Secondary|Change From Baseline in Insulin Sensitivity (SI) at Week 2|"SI is estimated from modeling of the insulin and glucose values during the intravenous glucose tolerance test (ivGTT).
Change = Week 2 - Baseline."|Baseline and Week 2|One patient from each group was excluded from the analysis since they were missing SI data at both Baseline and Week 2.||[mU/L]^-1·[min]^-1||95% Confidence Interval|Mean
821770|NCT01156116|Primary|Change From Baseline in Area Under the Curve (AUC) Glucose at Week 2|"The area under the glucose time curve, between 0 and 120 minutes of the OGTT, was calculated for each patient using the trapezoidal rule .
Change = Week 2 - Baseline."|Baseline and Week 2|One patient in the Placebo group who withdrew prior to any testing was excluded from the analysis.||(mg/dL)*min||95% Confidence Interval|Mean
821771|NCT01156142|Secondary|Patient Preference for Continuing Therapy With Oral Doxepin Hydrochloride|After each dose was administered, patients were asked if they would like to continue rinses with that particular agent. The percentage of patients who expressed an interest in continuing therapy are reported below.|Up to 9 days|||percentage of patients|||Number
821772|NCT01156142|Secondary|Incidence of Using Alternative Analgesics Between 2 and 4 Hours After the Initial Mouthwash|The incidence of utilizing additional analgesics between 2 and 4 hours after the initial mouthwash will be compared between the arms by the Chi-square test .|Up to 9 days|||percentage of patients|||Number
821773|NCT01156142|Secondary|Total Drowsiness Increase|The total drowsiness increase will be calculated by the area under the curve (AUC) adjusting for baseline, with time scale replaced by a numerical scale of 1,2,3,4,5,6. The numerical scale will be used rather than the raw time scale in order to give proper weights to more immediate patient-reported mouth pain outcomes after treatment. The AUC will be calculated by proration when there are terminal missing data. If the missing data are intermittent, simple imputation will be applied to calculate the AUC. The question ('On a scale from 0 to 10, what number best describes your DROWSINESS now?') used 11-point numerical analog scales (0 (no drowsiness) to 10 (extreme drowsiness, leading to sleep) scores) to measure total drowsiness increase. The AUCs for the two treatment arms were compared by using the Wilcoxon rank sum test with 95% CIs. The statistical analysis will be the same as the primary analysis.|Up to 9 days|If a patient cancels, is missing baseline data, or only provides baseline data, he/she will be excluded from the statistical analysis.||units on a scale||Standard Deviation|Mean
821774|NCT01156142|Secondary|Total Stinging or Burning From the Oral Rinse|The total stinging or burning from the oral rinse will be calculated by the area under the curve (AUC) adjusting for baseline, with time scale replaced by a numerical scale of 1,2,3,4,5,6. The numerical scale will be used rather than the raw time scale in order to give proper weights to more immediate patient-reported mouth pain outcomes after treatment. The AUC will be calculated by proration when there are terminal missing data. If the missing data are intermittent, simple imputation will be applied to calculate the AUC. The question ('On a scale from 0 to 10, what number best describes any STINGING OR BURNING FROM THE ORAL RINSE now?') used 11-point numerical analog scales (0 (no stinging or burning) to 10 (worst stinging or burning possible) scores) to total stinging or burning from the oral rinse. The AUCs for the two treatment arms were compared by using the Wilcoxon rank sum test with 95% CIs.The statistical analysis will be the same as the primary analysis.|Up to 9 days|If a patient cancels, is missing baseline data, or only provides baseline data, he/she will be excluded from the statistical analysis.||units on a scale||Standard Deviation|Mean
821775|NCT01156142|Secondary|Total Taste of the Oral Rinse|The total taste of the oral rinse will be calculated by the area under the curve (AUC) adjusting for baseline, with time scale replaced by a numerical scale of 1,2,3,4,5,6 , and analyzed in the same way as the primary endpoint. The numerical scale will be used rather than the raw time scale in order to give proper weights to more immediate patient-reported mouth pain outcomes after treatment. The AUC will be calculated by proration when there are terminal missing data. If the missing data are intermittent, simple imputation will be applied to calculate the AUC. The question ('On a scale from 0 to 10, what number best describes the TASTE OF THE ORAL RINSE now?') used 11-point numerical analog scales (0 (acceptable taste) to 10(terrible taste), with higher values representing worse outcome) to evaluate the total taste of the oral rinse. The AUCs for the two treatment arms were compared by using the Wilcoxon rank sum test with 95% CIs.|Up to 9 days|If a patient cancels, is missing baseline data, or only provides baseline data, he/she will be excluded from the statistical analysis.||units on a scale||Standard Deviation|Mean
821874|NCT01156532|Secondary|Mean Psoriasis Area and Severity Index (PASI) Score Over Time|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). The mean PASI improvement was calculated using a linear regression model.|Baseline, Week 4, Week 8, Week 16|Participants with available data.||units on a scale||Standard Deviation|Mean
821776|NCT01156142|Primary|Total Pain Reduction (Mouth and Throat)|The total pain reduction will be calculated by the (average of mouth and throat) area under the curve (AUC) adjusting for baseline, with time scale replaced by a numerical scale of 1,2,3,4,5,6. The numerical scale will be used rather than the raw time scale in order to give proper weights to more immediate patient-reported mouth pain outcomes after treatment. The AUC will be calculated by proration when there are terminal missing data. If the missing data are intermittent, simple imputation will be applied to calculate the AUC. The question ('On a scale from 0 to 10, what number best describes your MOUTH PAIN due to your radiation treatment now?') used 11-point numerical analog scales (0 (no pain) to 10 (worst pain imaginable or possible) scores) to measure pain. The AUCs for the two treatment arms were compared by using the Wilcoxon rank sum test with 95% CIs.|Baseline and Day 1|If a patient cancels, is missing baseline data, or only provides baseline data, he/she will be excluded from the statistical analysis. The primary analysis of the total pain reduction will only use primary data from the first phase.||units on a scale||Standard Deviation|Mean
821777|NCT01156311|Other Pre-specified|Number of New or Newly Enlarging T2 Lesions|The number of new T2 lesions divided by the number of months since the reference visit during the Monotherapy Period and the Add-On Therapy Period.|Week -8 to Week 24|Number of participants in the Gd cohort with analyzable data in both Monotherapy and Add-on Therapy Periods. Gd cohort: BG00012-dosed participants with at least 1 Gd-enhancing lesion in any 1 of the 3 scans (Weeks -8, -4, or 0) during the Monotherapy Period.||lesions per month||Standard Deviation|Mean
821778|NCT01156311|Other Pre-specified|Average Number of New Gd-Enhancing Lesions: Weeks -4, 0 Average Versus Weeks 20, 24 Average|The average is calculated as (total number of lesions in non-missing scans / number of non-missing MRI scans).|Week -4 through Week 24|Gd cohort: BG00012-dosed participants with at least 1 Gd-enhancing lesion in any 1 of the 3 scans (Weeks -8, -4, or 0) during the Monotherapy Period.||lesions||Standard Deviation|Mean
821779|NCT01156311|Other Pre-specified|Average Number of Gadolinium (Gd)-Enhancing Lesions: Week -8, -4, 0 Average Versus Week 16, 20, 24 Average|The average is calculated as (total number of lesions in non-missing scans / number of non-missing magnetic resonance imaging [MRI] scans).|Week -8 through Week 24|Gd cohort: BG00012-dosed participants with at least 1 Gd-enhancing lesion in any 1 of the 3 scans (Weeks -8, -4, or 0) during the Monotherapy Period.||lesions||Standard Deviation|Mean
821780|NCT01156311|Primary|Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy|Percentage of participants with post-baseline values for selected urinalysis parameters requiring further evaluation. For urine microscopy, results were categorized for male and female participants. For males, normal/negative was considered 0 to 3 red blood cells/high-power field (rbc/hpf), and positive was categorized in the following stages: 4 to 10, 11 to 20, 21 to 149, and ≥ 150 rbc/hpf. For females, normal/negative was considered 0 to 8 rbc/hpf, and positive was categorized in the following stages: 9 to 20, 21 to 30, 31 to 149, and ≥ 150 rbc/hpf.|collected from the start of BG00012 administration through to Week 26 +/- 5 days|The Safety Population for the Combination Therapy Period was defined as any participant who took at least 1 capsule of BG00012 concurrently with the background therapy; n=participants in the safety population with at least 1 post-baseline value.||percentage of participants|||Number
821781|NCT01156311|Primary|Maximum Post-Baseline Values: Liver Enzymes for Combination Therapy|Percentage of participants with post-baseline liver enzyme values above the upper limit of normal (ULN). Liver enzymes included alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transpeptidase (GGT), and bilirubin. Elevated ALT/AST (ALT/AST ≥ 3*ULN) concurrent with elevated total bilirubin was also evaluated.|collected from the start of BG00012 administration through to Week 26 +/- 5 days|Participants in the safety population with at least one post-baseline value. Safety Population for the Combination Therapy Period was defined as any participant who took at least 1 capsule of BG00012 concurrently with the background therapy.||percentage of participants|||Number
821782|NCT01156311|Primary|Potentially Clinically Significant Hematology Laboratory Abnormalities for Combination Therapy|Percentage of participants with potentially clinically significant hematology laboratory abnormalities.|collected from the start of BG00012 administration through to Week 26 +/- 5 days|Participants in the safety population with at least one post-baseline value. Safety Population for the Combination Therapy Period was defined as any participant who took at least 1 capsule of BG00012 concurrently with the background therapy.||percentage of participants|||Number
821783|NCT01156311|Primary|Summary of Treatment-emergent Adverse Events (TEAEs) Occurring Post-BG00012 Dosing (Add-on Therapy Period)|An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not related to the study drug. A serious adverse event (SAE) was any untoward medical occurrence that, at any dose: resulted in death; in the view of the Investigator, placed the participant at immediate risk of death (a life-threatening event); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; was any other medically important event that, in the opinion of the Investigator, jeopardized the participant or required intervention to prevent one of the other outcomes above. TEAE was defined as having an onset date that was on or after the start of study treatment (BG00012), or that worsened after the start of study treatment.|AEs were collected from enrollment until the final study visit (Week 26 +/-5 days).|The Safety Population for the Combination Therapy Period was defined as any participant who took at least 1 capsule of BG00012 concurrently with the background therapy.||percentage of participants|||Number
821797|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 25|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 25|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
821875|NCT01156532|Secondary|Adherence to Adalimumab Treatment|Adherence was measured by how many times a participant had a discontinuation (i.e., missed a study dose) during the 16 weeks of treatment.|up to 16 weeks|Participants who received at least one dose of study treatment.||participants|||Number
829555|NCT01220557|Secondary|CES-D Score|Depressive symptoms were assessed using the German version of the Centre for Epidemiologic Studies Depression Scale (CES-D), an instrument for measuring number and severity of depressive symptoms.|6 month follow up||||||
821784|NCT01156311|Other Pre-specified|Summary of Adverse Events (AEs) Occurring Before BG00012 Dosing (Monotherapy Period)|Percentage of participants with AEs, serious AEs (SAEs), and discontinuations due to AEs. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not related to the study drug. An SAE was any untoward medical occurrence that, at any dose: resulted in death; in the view of the Investigator, placed the participant at immediate risk of death (a life-threatening event); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; was any other medically important event that, in the opinion of the Investigator, jeopardized the participant or required intervention to prevent one of the other outcomes above. AEs were categorized as mild, moderate, or severe. All AEs occurring from enrollment to the day before BG00012 dosing are included.|from time of enrollment until day before first administration of BG00012 (Week -8 to Week 0)|The Safety Population for the Monotherapy Period was defined as any participant who took at least 1 dose of background therapy.||percentage of participants|||Number
821785|NCT01156363|Secondary|Percentage of Participants Requiring Dose Adjustments|Dose adjustment included: Dose Increase; No Change; and Dose Decreased. Participants who did not have this data available are reported as Not Done. Results are reported for overall treatment arm.|Baseline to Month 1; Month 1 to 2; Month 2 to 3; Month 3 to 4; Month 4 to 5; Month 5 to 6; Month 6 to 7; Month 7 to 8|ITT population. Here, number of participants analyzed signifies participants who were evaluable for this outcome and n signifies participants who were evaluable for specified time-point.||percentage of participants|||Number
821786|NCT01156363|Secondary|Mean Time Participants Spent Having Hb Concentration Within Target Range|Target Hb concentration was between 10.0 and 12.0 g/dL.|Weeks 1 to 32|ITT Population.||days||Standard Deviation|Mean
821787|NCT01156363|Secondary|Change in Hb Concentration Between Reference and Treatment Period|The baseline (reference) hemoglobin was defined as the average of the three assessments recorded during the screening and baseline visits (Week -2, -1, and 0).|Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8|ITT Population. Here, n signifies participants evaluable at specified time-point for each arm, respectively.||g/dL||Standard Deviation|Mean
821788|NCT01156363|Secondary|Mean Monthly Hb Values|The baseline (reference) hemoglobin was defined as the average of the three assessments recorded during the screening and baseline visits (Week -2, -1, and 0).|Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8|ITT Population. Here, n signifies participants evaluable at specified time-point for each arm, respectively.||g/dL||Standard Deviation|Mean
821789|NCT01156363|Primary|Percentage of Participants Maintaining Average Hemoglobin (Hb) Concentration Within the Target Range|Percentage of participants who maintained the Hb concentration within target range (between 10.0 and 12.0 grams per deciliter [g/dL]) throughout the treatment period were reported.|Weeks 1 to 32|ITT Population.||percentage of participants|||Number
821790|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 25|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 25|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
821791|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 25|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 25|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
821792|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Tongue at Day 25|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 25|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
821793|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Gingiva at Day 25|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 25|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
821794|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 25|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 25|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
821795|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 25|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 25|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
823171|NCT01163162|Secondary|Creatinine Clearance|The primary outcome variable will be creatinine clearance. Subject will be used as random variable and maximal likelihood estimation methods will be used. We expect no differences between periods.|1 Week|||ml/min||95% Confidence Interval|Mean
821798|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 24 - Post-treatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 24 - Post-treatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
821799|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 24 - Post-treatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 24 - Post-treatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
821800|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Tongue at Day 24 - Post-treatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 24 - Post-treatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
821801|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Gingiva at Day 24 - Post-treatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 24 - Post-treatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
821802|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 24 - Post-treatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 24 - Post-treatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
821803|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 24 - Post-treatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 24 - Post-treatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
821804|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 24 - Post-treatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 24 - Post-treatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
821805|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 24 - Post-treatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 24 - Post-treatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
821806|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 24 - Pretreatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 24 - Pretreatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
821807|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 24 - Pretreatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 24 - Pretreatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
821808|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Tongue at Day 24 - Pretreatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 24 - Pretreatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
821809|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Gingiva at Day 24 - Pretreatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 24 - Pretreatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
821810|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 24 - Pretreatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 24 - Pretreatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
821811|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 24 - Pretreatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 24 - Pretreatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
821812|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 24 - Pretreatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 24 - Pretreatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
821813|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 24 - Pretreatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 24 - Pretreatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
821814|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 5|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 5|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
821815|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 5|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 5|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
821816|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Tongue at Day 5|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 5|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
821817|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Gingiva at Day 5|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 5|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
821818|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 5|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 5|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
821819|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 5|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 5|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
823285|NCT01170663|Secondary|Cmax After 7th Ramucirumab (IMC-1211B) Infusion||Cycle 4, Day 1, 1 hour post end of infusion (28-day cycles)|All participants who received Ramucirumab (IMC-1121B) plus Paclitaxel and had Cmax observations at specific timepoint.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
821820|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 5|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 5|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
821821|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 5|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 5|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
821822|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 3|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 3|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
821823|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 3|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 3|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
821824|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Tongue at Day 3|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 3|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
821825|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Gingiva at Day 3|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 3|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
821826|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 3|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 3|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
821827|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 3|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 3|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
821828|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 3|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 3|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
821829|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 3|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 3|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
821830|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 1 – Post-treatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 1 – Post-treatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
821889|NCT01156701|Secondary|Number of Patients With Bronchitis|The frequency of bronchitis among the four cohorts was measured.|2006-2009|The study population consisted of individuals who were at least 5 years old and had been continuously enrolled for at least 6 months in the Normative Health Informatics (NHI) insurance claims database during the influenza seasons of 2006-2009 (October-April).||patients|||Number
821831|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 1 – Post-treatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 1 – Post-treatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
821832|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Tongue at Day 1 – Post-treatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 1 – Post-treatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
821833|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Gingiva at Day 1 – Post-treatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 1 – Post-treatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
821834|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 1 – Post-treatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 1 – Post-treatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
821835|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 1 – Post-treatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 1 – Post-treatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
821836|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 1 – Post-treatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 1 – Post-treatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
821837|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 1 – Post-treatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 1 – Post-treatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
821838|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 1 – Baseline/Pretreatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 1 – Baseline/Pretreatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
821839|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 1 – Baseline/Pretreatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 1 – Baseline/Pretreatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
821840|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Tongue at Day 1 – Baseline/Pretreatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 1 – Baseline/Pretreatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
821841|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Gingiva at Day 1 – Baseline/Pretreatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 1 – Baseline/Pretreatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
821842|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 1 – Baseline/Pretreatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 1 – Baseline/Pretreatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
821843|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 1 – Baseline/Pretreatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 1 – Baseline/Pretreatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
821844|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 1 – Baseline/Pretreatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 1 – Baseline/Pretreatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
821845|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 1 – Baseline/Pretreatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 1 – Baseline/Pretreatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
821846|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Screening|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Screening|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
821847|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Screening|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Screening|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
821848|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Tongue at Screening|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Screening|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
821849|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Gingiva at Screening|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Screening|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
821850|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Screening|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Screening|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
821851|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Screening|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Screening|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
821852|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Labial Mucosa at Screening|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Screening|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
821853|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Screening|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Screening|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
821854|NCT01156376|Primary|Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 25|Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.|Day 25|Analysis was based on subjects with measurements for this variable.||Percentage of Participants|||Number
821855|NCT01156376|Primary|Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 24 – Post-treatment|Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.|Day 24 – Post-treatment|Analysis was based on subjects with measurements for this variable.||Percentage of Participants|||Number
821856|NCT01156376|Primary|Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 24 – Pretreatment|Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.|Day 24 – Pretreatment|Analysis was based on subjects with measurements for this variable.||Percentage of Participants|||Number
821857|NCT01156376|Primary|Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 5|Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.|Day 5|Analysis was based on subjects with measurements for this variable.||Percentage of Participants|||Number
821858|NCT01156376|Primary|Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 3|Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.|Day 3|Analysis was based on subjects with measurements for this variable.||Percentage of Participants|||Number
821859|NCT01156376|Primary|Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 1 – Post-treatment|Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.|Day 1 – Post-treatment|Analysis was based on subjects with measurements for this variable.||Percentage of Participants|||Number
821860|NCT01156376|Primary|Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 1 – Baseline/Pretreatment|Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.|Day 1 – Baseline/Pretreatment|Analysis was based on subjects with measurements for this variable.||Percentage of Participants|||Number
821861|NCT01156376|Primary|Percentage of Participants With an Abnormal Condition by Anatomical Site at Screening|Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.|Screening|Analysis was based on subjects with measurements for this variable.||Percentage of Participants|||Number
821862|NCT01156480|Secondary|Mortality||at 40 weeks corrected gestational age||||||
821863|NCT01156480|Secondary|Growth Velocity||at 40 weeks CGA||||||
821864|NCT01156480|Secondary|Length of Stay|this will be assessed at the time of discharge, around 40 weeks CGA on average. A subset of infants may be discharged later than 40 weeks corrected gestational age (CGA), however, so these infants will need to have length of stay assessed later than 40 weeks CGA.|at 40 weeks corrected gestational age||||||
821865|NCT01156480|Secondary|Time to Full Enteral Feeds|this will be assessed as the time needed to achieve full enteral feeds following the diagnosis of NEC. On average, it will be assessed at 40 weeks CGA, near the time of discharge, but there is a subset of infants who will not yet have achieved full enteral feeds at that time, so it may need to be assessed later than 40 weeks CGA|at 40 weeks corrected gestational age||||||
821866|NCT01156480|Secondary|Time on Parenteral Nutrition||at 40 weeks corrected gestational age||||||
821867|NCT01156480|Secondary|Incidence of Sepsis||at 40 weeks corrected gestational age||||||
821868|NCT01156480|Secondary|Need for Gastrointestinal Surgery||at 36 weeks corrected gestational age||||||
821869|NCT01156480|Secondary|Spontaneous Intestinal Perforation||at 36 weeks corrected gestational age||||||
821870|NCT01156480|Secondary|Gastrointestinal (GI) Failure (Defined as Not Being on Full Enteral Feeds of 120kcal/kg/Day at 36 Weeks Corrected Age)||36 weeks corrected gestational age||||||
821871|NCT01156480|Primary|CRP Level|C-reactive protein (CRP) is a non-specific measure of inflammation, usually elevated in infants diagnosed with NEC|7 days|||mg/L|||Number
821872|NCT01156480|Primary|CRP Level|C-reactive protein is a non-specific marker of inflammation, noted to be elevated in infants diagnosed with NEC.|3 days|||mg/L|||Number
821873|NCT01156532|Secondary|Mean Dermatology Life Quality Index (DLQI) Score Over Time|DLQI score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. The mean DLQI improvement was calculated using a linear regression model.|Baseline, Week 4, Week 8, Week 16|Participants with available data.||units on a scale||Standard Deviation|Mean
821890|NCT01156701|Secondary|Number of Patients With Pneumonia|The frequency of pneumonia among the four cohorts was measured..|2006-2009|The study population consisted of individuals who were at least 5 years old and had been continuously enrolled for at least 6 months in the Normative Health Informatics (NHI) insurance claims database during the influenza seasons of 2006-2009 (October-April).||patients|||Number
821876|NCT01156532|Secondary|Number of Participants With Serious Adverse Events (SAEs)|An adverse event was considered an SAE if it met any of the following criteria: death of the participant; life-threatening event; hospitalization; prolongation of hospitalization; congenital anomaly; persistent or significant disability/incapacity; an important medical event requiring medical or surgical intervention to prevent serious outcome; spontaneous or elective abortion. SAEs included the occurrence of tuberculosis, opportunistic infection, and malignancy.|From the time of informed consent until 70 days (5 half-lives) after the last dose of study drug (treatment was 16 weeks).|Participants who received at least one dose of study treatment.||participants|||Number
821877|NCT01156532|Secondary|European Quality of Life 5 Dimensions (EQ-5D) Index Score at Baseline and Week 16|EQ-5D is a self-reported health outcome which measures mobility, self-care, usual activities, pain discomfort, anxiety, and depression. An overall score is derived that measures from -0.59 (worst) to +1 (best). Improvement was defined as a mean score increase of at least 0.2.|Baseline, Week 16|Participants with available data.||units on a scale||Standard Deviation|Mean
821878|NCT01156532|Primary|Percentage of Participants Reaching a Minimal Important Difference (MID) in the Dermatology Life Quality Index (DLQI) Score|Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. MID for the DLQI was defined as a score decrease from baseline of 2.3 to 5. The mean DLQI improvement was calculated using a linear regression model.|Baseline to Week 16|Participants with available data.||percentage of participants||95% Confidence Interval|Number
821879|NCT01156532|Primary|Percentage of Participants Reaching a Psoriasis Area and Severity Index 75 (PASI-75) Response|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI-75 responders are the participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The mean PASI improvement was calculated using a linear regression model.|Baseline to Week 16|Participants with available data. One participant was excluded from the analysis because only baseline and not follow-up information was available. Furthermore, 3 participants did not have their PASI measurement available either at baseline or at their last follow-up visit.||percentage of participants||95% Confidence Interval|Number
821880|NCT01156571|Secondary|Incidence of Major/Minor Non-coronary Artery Bypass Graft (CABG)-Related Hemorrhage by Clinical Relevant Criteria - GUSTO Severe/Life-threatening, Moderate and Mild|GUSTO = Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries trial|48 hours after randomization|||participants|||Number
821881|NCT01156571|Secondary|Individual Incidence of Stent Thrombosis (ST), Death, Myocardial Infarction (MI) and Ischemia-driven Revascularization (IDR)|CEC-adjudicated results (mITT population)|48 hours after randomization|||participants|||Number
821882|NCT01156571|Primary|The Composite Incidence of All-cause Mortality, Myocardial Infarction (MI), Ischemia-driven Revascularization (IDR) and Stent Thrombosis (ST)|Clinical Events Committee (CEC)-adjudicated results (modified intent-to-treat [mITT] population)|48 hours after randomization|||participants|||Number
821883|NCT01156597|Secondary|Cholesterol Efflux Capacity of HDL|The ability of serum HDL to remove cholesterol from cultured cells will be assessed as an in vitro method to evaluate a functional changes in HDL mediated by changes due to pioglitazone treatment. Cells were incubated with 2% serum from each study subject diluted in culture medium and incubations were performed for a total of 4 hours. Cholesterol efflux was calculated as the percent of cholesterol removed from the cells and appearing in the culture medium normalized to a reference serum pool as described in detail by de la Llera-Moya et al (de la Llera-Moya M, Drazul-Schrader D, Asztalos BF, Cuchel M, Rader DJ, Rothblat GH. The ability to promote efflux via ABCA1 determines the capacity of serum specimens with similar high-density lipoprotein cholesterol to remove cholesterol from macrophages. Arterioscler Thromb Vasc Biol. 2010 Apr;30(4):796-801. doi: 10.1161/ATVBAHA.109.199158. PMID: 20075420).|24 weeks|||Ratio||Standard Deviation|Mean
821884|NCT01156597|Secondary|HDL Apolipoprotein Levels at Study End-point|Lipoproteins will be isolated and analyzed using the gradient ultracentrifugation-high pressure liquid chromatography technique to isolate very low-density lipoprotein (VLDL), intermediate density lipoprotein (IDL), LDL, and high density lipoprotein (HDL) subfractions. Protein and lipid compositions of HDL is determined|24 weeks|||mg/dL||Standard Deviation|Mean
821885|NCT01156597|Primary|Increased HDL-Cholesterol and Decreased Triglycerides|"The primary endpoint will be increased high density lipoprotein cholesterol and decreased triglycerides measured as the difference after 12 or 24 weeks of treatment from baseline levels. The data are expressed as the percent change from the baseline value and calculated using he equation:
Change=[100%*(Endpoint value – Baseline Value)/Baseline Value]"|24 weeks|All subjects that completed the study were used for the final analysis||% Change||Standard Deviation|Mean
821886|NCT01156701|Other Pre-specified|Number of Participants Experiencing Hospitalization or Death Due to Influenza|The frequency of hospitalization and death in the study population was analyzed.|Baseline|The study population consisted of individuals who were at least 5 years old and had been continuously enrolled for at least 6 months in the Normative Health Informatics (NHI) insurance claims database during the influenza seasons of 2006-2009 (October-April).||patients|||Number
821887|NCT01156701|Other Pre-specified|Number of Patients With Respiratory Outcomes||Baseline|The study population consisted of individuals who were at least 5 years old and had been continuously enrolled for at least 6 months in the Normative Health Informatics (NHI) insurance claims database during the influenza seasons of 2006-2009 (October-April).||patients|||Number
821888|NCT01156701|Secondary|Number of Patients With Any Respiratory Diagnosis|The frequency of any respiratory diagnosis among the four cohorts was measured.|2006-2009|The study population consisted of individuals who were at least 5 years old and had been continuously enrolled for at least 6 months in the Normative Health Informatics (NHI) insurance claims database during the influenza seasons of 2006-2009 (October-April).||patients|||Number
822146|NCT01160822|Secondary|Part B: Physician's Global Assessment of Response to Treatment at Week 8|The study physician made a global assessment of response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor.|Week 8|Pharmacodynamic analysis set, where data were available.||participants|||Number
821893|NCT01156792|Secondary|Number of Participants Withdrawn Due to Lack of Efficacy During the Last 3 Weeks of the 6-week Treatment Period|Participants were withdrawn if they met any of the following three criteria for ‘lack of efficacy’: 1) Clinic FEV1 below the FEV1 ‘Stability Limit’ value, 2) During any consecutive 7-day period, the participant experienced PEF fallen below the PEF ‘Stability Limit’ for more than 3 days, or if >= 12 inhalations per day of albuterol were used for more than 2 days, and 3) Ashtma exacerbation. The number of withdrawals due to lack of efficacy were summarized for each treatment and Fisher’s Exact test was used for comparison with placebo add-on. Withdrawals occurring during active washout periods are not included.|Week 4 to Week 6|ITT Population.||Number of participants|||Number
821894|NCT01156792|Secondary|Percentage of Nights Without Awakenings Due to Asthma During the Last 3 Weeks of the 6-week Treatment Period|Night time asthma symptoms were recorded every morning upon rising, before taking any rescue or study medication and before assessing the PEF. Symptoms were recorded on a 5-point scale: 0 = no symptoms during the night, 1 = symptoms causing to wake once, 2 = symptoms causing to wake twice or more, 3 = symptoms causing to be awake most of the night, 4 = could not sleep due to severe symptoms. Participants recorded the symptoms in a daily eDiary. The number of nights with no awakenings due to asthma during the last 3 weeks of the 6-week treatment period were counted, and percentage calculated by dividing by 21 and multiplying by 100. Analysis was done using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant.|Week 4 to Week 6|ITT Population. Only those participants available at the specified time point were analyzed.||Percentage of nights||Standard Error|Least Squares Mean
821895|NCT01156792|Secondary|Percentage of Rescue-free Nights During the Last 3 Weeks of the 6-week Treatment Period|Albuterol was provided as a rescue medication, and participants were required to record rescue medication use in the morning and in the evening. Participants recorded the number of inhalations of rescue medication in a daily eDiary. The number of nights when rescue medication was not used (“rescue-free nights”) during the last 3 weeks of the 6-week treatment period were counted, and percentage calculated by dividing by 21 and multiplying by 100. Analysis was done using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant.|Week 4 to Week 6|ITT Population. Only those participants available at the specified time point were analyzed.||Percentage of nights||Standard Error|Least Squares Mean
821896|NCT01156792|Secondary|Percentage of Rescue-free Days During the Last 3 Weeks of the 6-week Treatment Period|Albuterol was provided as a rescue medication, and participants were required to record rescue medication use in the morning and in the evening. Participants recorded the number of inhalations of rescue medication in a daily eDiary. The number of days when rescue medication was not used (“rescue-free days”) during the last 3 weeks of the 6-week treatment period were counted, and percentage calculated by dividing by 21 and multiplying by 100. Analysis was done using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant.|Week 4 to Week 6|ITT Population. Only those participants available at the specified time point were analyzed.||Percentage of days||Standard Error|Least Squares Mean
821897|NCT01156792|Secondary|Percentage of Symptom-free Nights During the Last 3 Weeks of the 6 Week Treatment Period|Night time asthma symptoms were recorded every morning upon rising, before taking any rescue or study medication and before assessing the PEF. Symptoms were recorded on a 5-point scale ranging from ‘0’ (implying no symptoms) to 4 (implying severe symptoms). Participants recorded the symptoms in a daily eDiary. The number of nights when symptoms were not experienced (“symptom-free nights”) during the last 3 weeks of the 6-week treatment period were counted, and percentage calculated by dividing by 21 and multiplying by 100. Analysis was done using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant.|Week 4 to Week 6|ITT Population. Only those participants available at the specified time point were analyzed.||Percentage of nights||Standard Error|Least Squares Mean
821898|NCT01156792|Secondary|Percentage of Symptom-free Days During the Last 3 Weeks of the 6-week Treatment Period|Daytime asthma symptoms were recorded every evening at bedtime, before taking any rescue or study medication and before assessing the PEF. Symptoms were recorded on a 6-point scale ranging from ‘0’ (implying no symptoms) to 5 (implying severe symptoms). Participants recorded the symptoms in a daily eDiary. The number of days when symptoms were not experienced (“symptom-free days”) during the last 3 weeks of the 6-week treatment period were counted, and percentage calculated by dividing by 21 and multiplying by 100. Analysis was done using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant.|Week 4 to Week 6|ITT Population. Only those participants available at the specified time point were analyzed.||Percentage of days||Standard Error|Least Squares Mean
821899|NCT01156792|Secondary|Daily Rescue Short-acting beta2-agonist (SABA) Use Averaged Over the Last 3 Weeks of the 6-week Treatment Period|A SABA (albuterol) was provided to participants as a rescue medication, to use as needed for symptomatic relief of asthma symptoms. Participants were required to record their albuterol use in the morning and in the evening. Participants recorded the number of inhalations of rescue medication in a daily eDiary. The daily rescue SABA use was averaged over the last 3 weeks of the 6-week treatment period, and analyzed using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant.|Week 4 to Week 6|ITT Population. Only those participants available at the specified time point were analyzed.||Number of inhalations||Standard Error|Least Squares Mean
821900|NCT01156792|Secondary|Daily Asthma Symptom Score Averaged Over the Last 3 Weeks of the 6-week Treatment Period|Daytime and night time asthma symptoms were recorded every evening at bedtime and every morning upon rising, respectively, before taking any rescue or study medication and before assessing the PEF. Symptoms were recorded on scales ranging from ‘0’ (implying no symptoms) to either 5 (for daytime symptoms) or 4 (for night time symptoms) (implying severe symptoms). Participants recorded the symptoms in a daily eDiary. 24-hour period asthma symptom scores were averaged over the last 3 weeks of the 6-week treatment period, and analyzed using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant.|Week 4 to Week 6|ITT Population. Only those participants available at the specified time point were analyzed.||Score on a scale||Standard Error|Least Squares Mean
821901|NCT01156792|Secondary|Daily (Average of Morning and Evening) PEF Averaged Over the Last 3 Weeks of the 6 -Week Treatment Period Between GSK2190915 and Montelukast Groups|The PEF is a measure of lung function and measures how fast a person can breathe out. PEF was measured every morning and evening prior to study medication dose and any rescue albuterol (bronchodilator) use. Participants recorded PEF in a daily eDiary. Daily average of morning and evening PEF was averaged over the last 3 weeks of the 6-week treatment period, and analyzed using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant. This outcome measure explored the efficacy between GSK2190915 and montelukast due to the dosing time difference.|Week 4 to Week 6|ITT Population. Only those participants available at the specified time point were analyzed.||L/min||Standard Error|Least Squares Mean
821902|NCT01156792|Secondary|Daily Evening PEF Averaged Over the Last 3 Weeks of the 6-week Treatment Period|The PEF is a measure of lung function and measures how fast a person can breathe out. PEF was measured every evening prior to study medication dose and any rescue albuterol (bronchodilator) use. Participants recorded PEF in a daily eDiary. Daily evening PEF was averaged over the last 3 weeks of the 6-week treatment period, and analyzed using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant.|Week 4 to Week 6|ITT Population. Only those participants available at the specified time point were analyzed.||L/min||Standard Error|Least Squares Mean
821903|NCT01156792|Secondary|Daily Trough (Morning Pre-dose and Pre-rescue Bronchodilator) Morning Peak Expiratory Flow (PEF) Averaged Over the Last 3 Weeks of the 6-week Treatment Period|The PEF is a measure of lung function and measures how fast a person can breathe out. Trough PEF was measured every morning prior to study medication dose and any rescue albuterol (bronchodilator) use. Participants recorded PEF in a daily electronic diary (eDiary). Daily trough morning PEF was averaged over the last 3 weeks of the 6-week treatment period, and analyzed using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant.|Week 4 to Week 6|ITT Population. Only those participants available at the specified time point were analyzed.||Liters/minute (L/min)||Standard Error|Least Squares Mean
821904|NCT01156792|Primary|Trough (AM Pre-dose and Pre-rescue Bronchodilator) Forced Expiratory Volume in 1 Second (FEV1) at the End of the 6-week Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured electronically using spirometry, prior to study medication and any rescue albuterol (bronchodilator) use. At the end of the 6-week treatment period, FEV1 was measured approximately 24 hours after the participant’s last morning dose of study medication and approximately 12 hours after the evening dose of study medication. Trough FEV1 was analyzed using mixed effect analysis of covariance (ANCOVA) model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effect of participant. Intent-to-Treat Population is defined as all participants who were randomized and received at least one dose of study drug.|End of Week 6|ITT Population. Only those participants available at the specified time point were analyzed.||Liters (L)||Standard Error|Least Squares Mean
821905|NCT01156844|Secondary|Change From Baseline in the Forced Expiratory Volume in 1 Second Standardized (With Respect to Time) Area Under the Curve (AUC) From 0 to 12 Hours (FEV1 AUC 0-12h) After Two Weeks of Treatment|Spirometry was conducted according to internationally accepted standards. Standardized area under the curve (AUC 0-12 hours) of FEV1 measurements taken at pre-dose to 12 hours post-dose was calculated based on the trapezoidal rule and was adjusted for the area per time unit by using the scheduled time of measurements for FEV1. Analysis of covariance model was used with baseline FEV1 as a continuous covariate.|Baseline, 0 to 12 hours post dose week 2|Pharmacodynamic (PD) Analysis Set included all randomized participants who received at least one dose of study drug and who had evaluable PD data.||Liters||90% Confidence Interval|Least Squares Mean
821906|NCT01156844|Primary|Change From Baseline in the Forced Expiratory Volume in 1 Second Standardized (With Respect to Time) Area Under the Curve (AUC) From 0 to 48 Hours (FEV1 AUC 0-48h) After Two Weeks of Treatment|Spirometry was conducted according to internationally accepted standards. Standardized area under the curve (AUC 0-48 hours) of FEV1 measurements taken at pre-dose to 48 hours post-dose was calculated based on the trapezoidal rule and was adjusted for the area per time unit by using the scheduled time of measurements for FEV1. Analysis of covariance model was used with baseline FEV1 as a continuous covariate.|Baseline, 0 to 48 hours post dose week 2|Pharmacodynamic (PD) Analysis Set included all randomized participants who received at least one dose of study drug and who had evaluable PD data.||Liters||90% Confidence Interval|Least Squares Mean
821907|NCT01156844|Primary|Change From Baseline in the Forced Expiratory Volume in 1 Second Standardized (With Respect to Time) Area Under the Curve (AUC) From 0 to 24 Hours Post Dose (FEV1 AUC 0-24h) After Two Weeks of Treatment|Spirometry was conducted according to internationally accepted standards. Standardized area under the curve (AUC 0-24 hours) of FEV1 measurements taken at pre-dose to 24 hours post-dose was calculated based on the trapezoidal rule and was adjusted for the area per time unit using the scheduled time of measurements for FEV1. Analysis of covariance model was used with baseline FEV1 as a continuous covariate.|Baseline, 0-24 hours post dose week 2|Pharmacodynamic (PD) Analysis Set included all randomized participants who received at least one dose of study drug and who had evaluable PD data.||Liters||90% Confidence Interval|Least Squares Mean
821908|NCT01156844|Primary|Change From Baseline in the Trough Forced Expiratory Volume in One Second (FEV1) After Two Weeks of Treatment|Spirometry was conducted according to internationally accepted standards. Trough FEV1 values were calculated as the mean of the 23.17 hours and 23.75 hours post morning dose FEV1 measurements. Analysis of covariance model was used with baseline FEV1 as a continuous covariate.|Baseline to week 2|Pharmacodynamic (PD) Analysis Set included all randomized participants who received at least one dose of study drug and who had evaluable PD data.||Liters||90% Confidence Interval|Least Squares Mean
821909|NCT01156987|Primary|Lesions|Number of lesions detected|at time of read by two radiologiests, compared to biopsy within 7 days.|||lesions|||Number
821910|NCT01157065|Primary|Incidence of Events of Special Interest (ESI)|An ESI was a protocol-specified event of scientific and medical concern specific to the Sponsor's product or program where ongoing monitoring and rapid communication by the Investigator to the Sponsor was appropriate. These adverse events could have been serious or nonserious and may have required further investigation in order to characterize and understand.|Up to Day 30|Intent-to-treat (ITT): All patients who received study medication and completed at least one scheduled post-injection study visit||events|||Number
821911|NCT01157065|Primary|Mean Reduction From Baseline in Central Subfield (CSF) Retinal Thickness at Week 4|The thickness of the retina was measured using a non-invasive device that produces cross-sectional and 3D images of the eye. The reduction was calculated by subtracting Week 4 visit value from the Baseline value. A positive number indicates a reduction in thickness compared to baseline, whereas a negative number indicates an increase in thickness. An increase in thickness as compared to baseline may indicate a progression of the underlying disease.|Week 4|All patients who received study medication, completed at least one scheduled post-injection study visit, and did not receive standard therapy prior to Week 4 assessment||microns||Standard Deviation|Mean
821912|NCT01157078|Secondary|Change in EuroQol - 5 Dimensions (EQ-5D) From Randomization (Week 8) to End of Treatment (Week 16)|A self-assessment questionnaire that provides 2 measures of health status. The EQ-5D index score is a weighted linear combination over 5 dimensions of health status. The score for each of the 5 dimensions can range from 1 to 3, and an equation is used to calculate the EQ-5D index score. The EQ-5D index score can range from possible negative values (minimum -0.415) to a maximum of 1.0. The EQ-VAS is a visual analog scale with a range of 0 to 100. For both variables, a higher score indicates a better health state.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
821913|NCT01157078|Secondary|Change in Irritability Symptoms as Measured by the Sheehan Irritability Scale (SIS) Total Score From Randomization (Week 8) to End of Treatment (Week 16)|A self-administered scale to be used by clinical subjects to rate suffering over the past week with regard to irritability symptoms. The total SIS score is the sum of 7 items, and ranges from 0 to 70. Each item is assessed on an 11-point scale where 0=not at all, 1-3=mildly, 4-6=moderately, 7-9=markedly, and 10=extremely. The SIS also records the number of days impaired by irritability.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
821914|NCT01157078|Secondary|Change From Randomization (Week 8) to End of Treatment (Week 16) in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q LES-Q-SF) Item 16|"The Q-LES-Q-SF (Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form) measures the patient’s satisfaction with medication and overall quality of life.
The 16th item is a global rating of overall life satisfaction and contentment, rated on a 1 to 5 scale. Higher scores are indicative of greater satisfaction."|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
821915|NCT01157078|Secondary|Change From Randomization (Week 8) to End of Treatment (Week 16) in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q LES-Q-SF) Item 15|"The Q-LES-Q-SF (Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form) measures the patient’s satisfaction with medication and overall quality of life.
The 15th item queries respondents’ satisfaction with the medication they are taking, rated on a 1 to 4 scale, score 0 indicates that no medication was taken. Higher scores are indicative of greater satisfaction."|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
821916|NCT01157078|Secondary|Change in Overall Quality of Life and Satisfaction From Randomization (Week 8) to End of Treatment (Week 16) by Assessing the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) % Maximum Total Score|The Q-LES-Q-SF (Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form)total score is derived by summing item scores 1 to 14. Higher scores are indicative of greater enjoyment or satisfaction in each domain. The Q-LES-Q-SF % maximum total score is calculated as 100% × (Q-LES-Q-SF total score – 14) / 56, and can range from 0% to 100%.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
821917|NCT01157078|Secondary|Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Family Life/Home Responsibilities Domain Score|A 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The 3 inter-correlated domains are school/work, social life, and family life/home responsibilities. The numerical rating for the SDS family life/home responsibilities domain score is 0- 10, where 10 is considered to be 'highly impaired'.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
821918|NCT01157078|Secondary|Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Social Life Domain Score|A 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The 3 inter-correlated domains are school/work, social life, and family life/home responsibilities. The numerical rating for the SDS social life domain score is 0- 10, where 10 is considered to be 'highly impaired'.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
821936|NCT01157117|Secondary|Change From Baseline to Month 38 in Antigen-specific Immunoglobulin G4 (IgG4)|Casein and beta-lactoglobulin milk proteins IgG4 levels were measured in plasma. The value for each participant was subtracted from the value for that participant at baseline. Month 38 was 6 months after treatment ended at Month 32.|Month 38|All randomized participants and untreated controls who had not withdrawn from the study, came to the clinic for their Month 38 visit, and for whom valid results were reported.||mgA/L||Full Range|Median
821919|NCT01157078|Secondary|Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Work/School Domain Score|A 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The 3 inter-correlated domains are school/work, social life, and family life/home responsibilities. The numerical rating for the work/school domain score is 0- 10, where 10 is considered to be 'highly impaired'.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
821920|NCT01157078|Secondary|Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by the Sheehan Disability Scale (SDS) Total Score|Sheehan Disability Scale (SDS) is 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The SDS total score is calculated as the sum of the score for the 3 inter-correlated domains (school/work, social life, and family life/home responsibilities) and ranges from 0 (unimpaired) to 30 (highly impaired).|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
821921|NCT01157078|Secondary|Change in MADRS Total Score From Randomization (Week 8) to Week 14|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to Week 14|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
821922|NCT01157078|Secondary|Change in MADRS Total Score From Randomization (Week 8) to Week 12|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to Week 12|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
821923|NCT01157078|Secondary|Change in MADRS Total Score From Randomization (Week 8) to Week 10|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to Week 10|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
821924|NCT01157078|Secondary|Change in MADRS Total Score From Randomization (Week 8) to Week 9|"A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.
MADRS is 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Randomization (Week 8) to Week 9|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
821925|NCT01157078|Secondary|Response in the Clinical Global Impression-Improvement (CGI-I) Defined as CGI-I Rating of “Very Much Improved” or “Much Improved” From Randomization (Week 8) to End of Treatment (Week 16)|A 3-part, clinician-administered scale that rates the improvement or worsening of the patient’s illness from randomization (baseline). Each item is scored on a 1 to 7 scale. CGI-I scores >4 indicate worsening, while scores <4 indicate improvement.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||percentage of participants analyzed|||Number
821926|NCT01157078|Secondary|Change in the Clinician-rated Global Outcome of Severity as Measured by the Clinical Global Impression-Severity (CGI-S) Score From Randomization (Week 8) to End of Treatment (Week 16)|A 3-part, clinician-administered scale that rates the improvement or worsening of the patient’s illness from randomization (baseline). Each item is scored on a 1 to 7 scale. Higher CGI-S scores indicate greater illness severity.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
821927|NCT01157078|Secondary|Change in Depressive Symptoms From Randomization (Week 8) to End of Treatment (Week 16) as Measured by Hamilton Rating Scale for Depression-17 Items (HAMD-17) Total Score|A 17-item, clinician-rated scale that assesses depressive symptoms. The HAMD-17 consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The HAMD-17 total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher HAMD-17 scores indicate more severe depression.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
821953|NCT01157169|Primary|Cmax of Buprenorphine.|Bioequivalence based on Buprenorphine Cmax (maximum observed concentration of drug substance in plasma).|Blood samples collected over a 144 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
821928|NCT01157078|Secondary|Sustained Remission, Defined as a MADRS Total Score of ≤8 at Week 12, Week 14, and End of Treatment (Week 16)|"The percentage of patients with a MADRS total score of ≤8 at Week 12, Week 14, and end of treatment (Week 16)was calculated.
MADRS is 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Week 12, Week 14, Week 16|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||percentage of participants analyzed|||Number
821929|NCT01157078|Secondary|Sustained Response, Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score and a MADRS Total Score of ≤12 at Week 12, Week 14, and End of Treatment (Week 16)|"The percentage of patients with a ≥50% reduction from randomization (Week 8) in MADRS total score and a MADRS total score of ≤12 at Week 12, Week 14, and end of treatment (Week 16) was calculated.
MADRS is 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Randomization (Week 8) to end of treatment (Week 16); Week 12, Week 14, and Week 16|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||percentage of patients analyzed|||Number
821930|NCT01157078|Secondary|Early and Sustained Response, Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score and a MADRS Total Score of ≤12 at Week 10, Week 12, Week 14, and End of Treatment (Week 16)|"The percentage of patients with a ≥50% reduction from randomization (Week 8) in MADRS total score and a MADRS total score of ≤12 at Week 10, Week 12, Week 14, and end of treatment (Week 16) was calculated.
MADRS is 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Randomization (Week 8) to end of treatment (Week 16); Week 10, Week 12, Week 14, and Week 16|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||percentage of participants analyzed|||Number
821931|NCT01157078|Secondary|Remission in Depressive Symptoms of MDD, Defined as MADRS Total Score of ≤8 at End of Treatment (Week 16)|"The percentage of patients with a MADRS total score of ≤8 at end of treatment (Week 16) was calculated.
MADRS is 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Week 16|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||percentage of participants analyzed|||Number
821932|NCT01157078|Secondary|Response in Depressive Symptoms of Major Depressive Disorder (MDD), Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score at End of Treatment (Week 16)|"The percentage of patients with a ≥50% reduction from randomization (Week 8) in MADRS total score at end of treatment (Week 16) was calculated.
MADRS is 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||percentage of participants analyzed|||Number
821933|NCT01157078|Primary|Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Randomization to End of Treatment.|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
821934|NCT01157117|Secondary|Change in Percent of Cells Positive for Cluster of Differentiation 63 (CD63) at Month 38 in Basophils Stimulated by Milk|Basophil cells isolated from blood using flow cytometry were stimulated with 5 different levels of milk and the percent of basophil cells that were CD63 positive was measured. The value for each participant obtained at Month 38 was subtracted from the value for that participant at baseline. The 5 different levels of milk stimulant were: 10 µg/mL, 1 µg/mL , 0.1 µg/mL , 0.01 µg/mL , and 0.001 µg/mL. Month 38 was 6 months after treatment ended at Month 32.|Month 38|All randomized participants and untreated controls who had not withdrawn from the study, came to the clinic for their Month 38 visit, and for whom valid results were reported.||percentage of CD63+ basophils||Full Range|Median
821935|NCT01157117|Secondary|Change in Percent of Cells Positive for Cluster of Differentiation 63 (CD63) at Month 32 in Basophils Stimulated by Milk|Basophil cells isolated from blood using flow cytometry were stimulated with 5 different levels of milk and the percent of basophil cells that were CD63 positive was measured. The value for each participant obtained at Month 32 was subtracted from the value for that participant at baseline. The 5 different levels of milk stimulant were: 10 µg/mL, 1 µg/mL , 0.1 µg/mL , 0.01 µg/mL , and 0.001 µg/mL. Month 32 was the last visit on treatment.|Month 32|All randomized participants and untreated controls who had not withdrawn from the study, came to the clinic for their Month 32 visit, and for whom valid results were reported.||percentage of CD63+ basophils||Full Range|Median
821954|NCT01157182|Secondary|AUC0-inf for Corrected Unconjugated Estrone(Area Under the Concentration-time Curve From Time Zero to Infinity)|Informational comparison of AUC0-inf values for Corrected Unconjugated Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
821937|NCT01157117|Secondary|Change From Baseline to Month 38 in Antigen-specific Immunoglobulin E (IgE)|The level of milk IgE in plasma as well as the IgE levels of 2 milk proteins, casein and beta-lactoglobulin, were measured. The value for each participant was subtracted from the value for that participant at baseline. Month 38 was 6 months after treatment ended at Month 32.|Month 38|All randomized participants and untreated controls who had not withdrawn from the study, came to the clinic for their Month 38 visit, and for whom valid results were reported.||kUA/L||Full Range|Median
821938|NCT01157117|Secondary|Change From Baseline to Month 32 in Antigen-specific Immunoglobulin G4 (IgG4)|Casein and beta-lactoglobulin milk proteins IgG4 levels were measured in plasma. The value for each participant was subtracted from the value for that participant at baseline. Month 32 was the last visit on treatment.|Month 32|All randomized participants and untreated controls who had not withdrawn from the study, came to the clinic for their Month 32 visit, and for whom valid results were reported.||mgA/L||Full Range|Median
821939|NCT01157117|Secondary|Change From Baseline to Month 32 in Antigen-specific Immunoglobulin E (IgE)|The level of milk IgE in plasma as well as the IgE levels of 2 milk proteins, casein and beta-lactoglobulin, were measured. The value for each participant was subtracted from the value for that participant at baseline. Month 32 was the last visit on treatment.|Month 32|All randomized participants and untreated controls who had not withdrawn from the study, came to the clinic for their Month 32 visit, and for whom valid results were reported.||kUA/L||Full Range|Median
821940|NCT01157117|Secondary|Change From Baseline to Month 32 in Area Under the Curve for Milk Endpoint Titration Prick Skin Test|A milk endpoint titration is a prick skin test using 5 serial 10-fold dilutions of milk which include 1:20 wt/vol, 1:200 wt/vol, 1:2,000 wt/vol, 1:20,000 wt/vol and 1:200,000 wt/vol. The score for each of these dilutions is calculated by subtracting the diameter of the saline control wheal from the diameter of the milk wheal (in millimeters). The area under the curve is calculated by adding together the scores from all 5 milk dilutions creating a composite score.|Month 32|All randomized participants who had not withdrawn from the study and came to the clinic for their Month 32 visit were assessed.||units on a scale||Full Range|Median
821941|NCT01157117|Secondary|Time to Maximum Tolerated Dose|Time to reach the maximum tolerated dose (MTD) of milk oral immunotherapy (OIT); MTD is the highest dose of milk powder the participant was able to consume for at least 14 consecutive days.|Baseline to completion of Escalation Phase at 22 to 40 weeks|Time to maximum tolerated dose could not be calculated because the maximum dose for the protocol was changed part way through the study after some subjects had already reached the maximum dose.|||||
821942|NCT01157117|Secondary|Percentage of Participants in the Xolair® (Omalizumab) Group vs. Placebo Group Developing Desensitization to Milk|Desensitization Assessment: Participants who successfully consumed without dose-limiting symptoms 10,000 mg of milk protein during a double-blind placebo-controlled oral food challenge were counted as successes.|Month 28|Participants who received any study treatment||percentage of participants|||Number
821943|NCT01157117|Secondary|Maximum Tolerated Dose of Milk Oral Immunotherapy (OIT)|Maximum tolerated dose of milk OIT is the highest dose of milk powder the participant was able to consume for at least 14 consecutive days.|Baseline to completion of Escalation Phase at 22 to 40 weeks|Participants who received any milk OIT dosing||mg milk powder||Standard Deviation|Mean
821944|NCT01157117|Secondary|Incidence of Severe Hypersensitivity Reactions to Milk OIT|Participants who had a change in mental status or hypotension as a milk OIT dosing symptom were counted as having a severe hypersensitivity reaction.|Through completion of milk OIT dosing (at Month 28 if failed desensitization OFC, at Month 30 if passed desensitization OFC)|Participants who received milk OIT dosing.||percentage of participants|||Number
821945|NCT01157117|Secondary|Incidence of Dosing Reactions to Milk OIT During the Maintenance Phase|Any reaction to daily milk OIT dosing recorded by the participant during the Maintenance Phase.|After completion of Escalation Phase at 22 to 40 weeks, the Maintenance Phase lasted up to Month 30|Participants who received milk OIT dosing during the Maintenance Phase.||percentage of participants|||Number
821946|NCT01157117|Secondary|Incidence of Dosing Reactions to Milk OIT During the Escalation Phase|Any reaction to daily milk OIT dosing recorded by the participant during the Escalation Phase.|Baseline to completion of Escalation Phase at 22 to 40 weeks|Participants who received any milk OIT dosing during the Escalation Phase.||percentage of participants|||Number
821947|NCT01157117|Primary|Percentage of Subjects in the Xolair® (Omalizumab) Group vs. Placebo Group Developing Clinical Tolerance to Milk|Tolerance Assessment: Participants who successfully consumed without dose-limiting symptoms 10,000 mg of milk protein during a double-blind placebo-controlled oral food challenge were then given an open feeding of milk and those who successfully consumed the open feeding were counted as successes.|Month 32 which is 8 weeks following the discontinuation of milk OIT for both groups and 4 months after discontinuation of omalizumab for the omalizumab group|The intention to treat (ITT) population was used which included all subjects randomized to double-blind treatment.||Percent of participants|||Number
821948|NCT01157169|Secondary|AUC0-inf for Norbuprenorphine.|Informational comparison of AUC0-inf (area under the concentration-time curve from time zero to infinity) values for the metabolite Norbuprenorphine.|Blood samples collected over a 144 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
821949|NCT01157169|Secondary|AUC0-t for Norbuprenorphine.|Informational comparison of AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration) values for the metabolite Norbuprenorphine.|Blood samples collected over a 144 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
821950|NCT01157169|Secondary|Cmax for Norbuprenorphine.|Informational comparison of Cmax (maximum observed concentration of drug substance in plasma) values for the metabolite Norbuprenorphine.|Blood samples collected over a 144 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
821951|NCT01157169|Primary|AUC0-inf for Buprenorphine.|Bioequivalence based on Buprenorphine AUC0-inf (area under the concentration-time curve from time zero to infinity).|Blood samples collected over a 144 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
821952|NCT01157169|Primary|AUC0-t for Buprenorphine.|Bioequivalence based on Buprenorphine AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).|Blood samples collected over a 144 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
821955|NCT01157182|Secondary|AUC0-t for Corrected Unconjugated Estrone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Informational comparison of AUC0-t values for Corrected Unconjugated Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
821956|NCT01157182|Secondary|Cmax for Corrected Unconjugated Estrone(Maximum Observed Concentration of Drug Substance in Plasma)|Informational comparison of Cmax values for Corrected Unconjugated Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg/mL||Standard Deviation|Mean
821957|NCT01157182|Secondary|AUC0-inf for Corrected Unconjugated Estradiol(Area Under the Concentration-time Curve From Time Zero to Infinity)|Informational comparison of AUC0-inf values for Corrected Unconjugated Estradiol.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
821958|NCT01157182|Secondary|AUC0-t for Corrected Unconjugated Estradiol.(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Informational comparison of AUC0-t values for Corrected Unconjugated Estradiol.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
821959|NCT01157182|Secondary|Cmax for Corrected Unconjugated Estradiol(Maximum Observed Concentration of Drug Substance in Plasma)|Informational comparison of Cmax values for Corrected Unconjugated Estradiol.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg/mL||Standard Deviation|Mean
821960|NCT01157182|Secondary|AUC0-inf for Uncorrected Unconjugated Estrone(Area Under the Concentration-time Curve From Time Zero to Infinity)|Informational comparison of AUC0-inf values for Uncorrected Unconjugated Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
821961|NCT01157182|Secondary|AUC0-t for Uncorrected Unconjugated Estrone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Informational comparison of AUC0-t values for Uncorrected Unconjugated Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
821962|NCT01157182|Secondary|Cmax for Uncorrected Unconjugated Estrone(Maximum Observed Concentration of Drug Substance in Plasma)|Informational comparison of Cmax values for Uncorrected Unconjugated Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg/mL||Standard Deviation|Mean
821963|NCT01157182|Secondary|AUC0-inf for Uncorrected Unconjugated Estradiol(Area Under the Concentration-time Curve From Time Zero to Infinity)|Informational comparison of AUC0-inf values for Uncorrected Unconjugated Estradiol.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
821964|NCT01157182|Secondary|AUC0-t for Uncorrected Unconjugated Estradiol(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Informational comparison of AUC0-t values for Uncorrected Unconjugated Estradiol.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
821965|NCT01157182|Secondary|Cmax for Uncorrected Unconjugated Estradiol(Maximum Observed Concentration of Drug Substance in Plasma)|Informational comparison of Cmax values for Uncorrected Unconjugated Estradiol.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg/mL||Standard Deviation|Mean
821966|NCT01157182|Secondary|AUC0-inf for Uncorrected Total Estrone(Area Under the Concentration-time Curve From Time Zero to Infinity)|Informational comparison of AUC0-inf values for Uncorrected Total Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
821967|NCT01157182|Secondary|AUC0-t for Uncorrected Total Estrone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Informational comparison of AUC0-t values for Uncorrected Total Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
821968|NCT01157182|Secondary|Cmax for Uncorrected Total Estrone(Maximum Observed Concentration of Drug Substance in Plasma)|Informational comparison of Cmax values for Uncorrected Total Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg/mL||Standard Deviation|Mean
821969|NCT01157182|Primary|AUC0-inf for Corrected Total Estrone(Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on Corrected Total Estrone AUC0-inf.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
821970|NCT01157182|Primary|AUC0-t for Corrected Total Estrone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on Corrected Total Estrone AUC0-t.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
821971|NCT01157182|Primary|Cmax for Corrected Total Estrone(Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Corrected Total Estrone Cmax.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg/mL||Standard Deviation|Mean
821972|NCT01157182|Primary|AUC0-inf for Norethindrone(Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on Norethindrone AUC0-inf.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
821973|NCT01157182|Primary|AUC0-t for Norethindrone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on Norethindrone AUC0-t.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
821974|NCT01157182|Primary|Cmax for Norethindrone(Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Norethindrone Cmax.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
822017|NCT01152385|Secondary|Change in High-sensitivity C-reactive Protein (Hs-CRP)||from baseline to 4 months|The analysis population was prior to rescue treatment (FAS)||mg/dL||Standard Deviation|Mean
821975|NCT01157234|Secondary|Plasma Arginine (ARG) Level Change From Baseline to Month-12 Between Groups|Percent change in plasma Arginine (umol/L)=[month-12 plasma Arginine level minus baseline plasma Arginine level] divided by [baseline plasma Arginine level] multiplied by 100, where all levels are in umol/L|Baseline, Month-12|Technical limitations constrained measurements of plasma Arginine, resulting in no analysis for this outcome.|||||
821976|NCT01157234|Secondary|Plasma Asymmetric Dimethylarginine (ADMA) Change From Baseline to Month 12 Between the Groups|Percent change in plasma ADMA (umol/L)=[month-12 plasma ADMA level minus baseline plasma ADMA level] divided by [baseline plasma ADMA level] multiplied by 100, where all levels are in umol/L.|Baseline, Month-12|Technical limitations constrained measurements of Asymmetric Dimethylarginine (ADMA), resulting in no analysis for this outcome.|||||
821977|NCT01157234|Post-Hoc|Percent Change in Plasma Nitric Oxide Level From Baseline to Month-12 of Treatment With Nebivolol in Transplant Recipients >/= 50 Years Old Compared With Metoprolol in Transplant Recipients Age >/= 50 Years Old.||Change in Baseline, Month-12|||percent change||Standard Error|Least Squares Mean
821978|NCT01157234|Post-Hoc|Percent Change in Plasma Nitric Oxide Level From Baseline to Month-twelve of Treatment With Nebivolol in Transplant Recipients >/= 50 Years Old Compared With Nebivolol in Transplant Recipients < 50 Years Old.||Change in Baseline, Month-12|Nebivolol and metoprolol groups were subdivided into <50 years old and >50 years old subgroups and differences between subgroups were analyzed.||percent change||Standard Error|Least Squares Mean
821979|NCT01157234|Post-Hoc|Percent Change in Plasma Nitric Oxide Level From Baseline to Month-12 of Treatment With Nebivolol in Transplant Recipients < 50 Years Old Compared With Metoprolol in Transplant Recipients < 50 Years Old||Change in Baseline, Month-12|Nebivolol and metoprolol groups were subdivided into <50 years old and >50 years old subgroups and differences between subgroups were analyzed.||percent change||Standard Error|Least Squares Mean
821980|NCT01157234|Post-Hoc|Percent Change in Plasma Nitric Oxide Level From Baseline to Month-12 of Treatment With Nebivolol in Transplant Recipients <50 Years Old Compared With Metoprolol in Transplant Recipients >/= 50 Years Old.||Baseline and Month-12|Nebivolol and metoprolol groups were subdivided into <50 years old and >50 years old subgroups and differences between subgroups were analyzed.||percent change||Standard Error|Least Squares Mean
821981|NCT01157234|Other Pre-specified|Plasma Nitric Oxide Level (Nmol/L) at Month-12 Between the Groups.||12 Months|Full analysis set included all participants who signed inform consent and received at least one dose of study drug||nmol/L||Standard Error|Least Squares Mean
821982|NCT01157234|Secondary|Number of Antihypertensive Drug Classes Change From Baseline to Month-12 Between the Groups.|Percent change in quantity of Anti-Hypertensive Drug Classes (AHDC)=[Month-12 absolute number of AHDC minus baseline absolute number of AHDC] divided by [baseline absolute number of AHDC] multiplied by 100.|Change in Baseline, Month-12|Percent change||percent change||Standard Error|Least Squares Mean
821983|NCT01157234|Secondary|Mean Arterial Blood Pressure (Millimeter, Mercury) Change From Baseline to Month-12 Between the Groups|"Absolute change in Mean Arterial Blood Pressure, (MAP), (millimeter, Mercury= Month-12 sitting trough MAP minus baseline sitting trough MAP.
Mean Arterial Pressure= 2/3 trough diastolic blood pressure + 1/3 trough systolic blood pressure"|Change in Baseline, Month-12|Full analysis set included all participants who signed inform consent and received at least one dose of study drug.||millimeter, Mercury||Standard Error|Least Squares Mean
821984|NCT01157234|Secondary|Diastolic Blood Pressure (Millimeter, Mercury) Change From Baseline to Month-12 Between the Groups|Absolute Change in Diastolic Blood Pressure (DBP), (millimeter, Mercury)= Month-12 sitting trough Diastolic Blood Pressure (millimeter, Mercury) level minus baseline sitting trough Diastolic Blood Pressure (millimeter, Mercury).|Change in Baseline, Month-12|Full analysis set included all participants who signed inform consent and received at least one dose of study drug.||millimeter, mercury||Standard Error|Least Squares Mean
821985|NCT01157234|Secondary|Systolic Blood Pressure (Millimeter, Mercury) Change From Baseline to Month-12 of Treatment Between the Groups|Absolute change in Systolic Blood Pressure (SBP), (millimeter, Mercury)=Month-12 sitting trough SBP level minus baseline sitting trough SBP level|Change in Baseline, Month-12|Full analysis set included all participants who signed inform consent and received at least one dose of study drug.||millimeter, Mercury||Standard Error|Least Squares Mean
821986|NCT01157234|Secondary|Estimated Glomerular Filtration Rate (ml/Minute) Change From Baseline to Month-12 Between the Groups|The changed percentage in Estimated Glomerular Filtration Rate (eGFR), (based on the Modification of Diet in Renal Disease Equation)=[Month-12 GFR level minus baseline eGFR level] divided by [baseline eGFR level] multiplied by 100, where all levels are in ml/min.|Change in Baseline, Month-12|Full analysis set included all participants who signed inform consent and received at least one dose of study drug.||percent change||Standard Error|Least Squares Mean
821987|NCT01157234|Primary|Plasma Nitric Oxide Level Change From Baseline to Month 12 Between the Groups.|Percent change in Nitric Oxide (NO) blood level (nmol/L)=[Month-12 NO blood level minus baseline NO blood level] divided by [baseline NO blood level] multiplied by 100, where all levels are in nmol/L.|Change in Baseline, Month-12|Full analysis set included all participants who signed informed consent and received at least one dose of study drug.||percent change||Standard Error|Least Squares Mean
821988|NCT01157351|Primary|Percentage of Participants in Each Event Category of First Treatment Failure|First treatment failure was a composite endpoint consisting of any of the following events: arrest/incarceration, psychiatric hospitalization, discontinuation (D/C) of antipsychotic treatment due to safety or tolerability, treatment supplementation with another antipsychotic due to inadequate efficacy, discontinuation of antipsychotic treatment due to inadequate efficacy, increase in level of psychiatric services to prevent imminent psychiatric hospitalization, suicide. A Treatment Failure Event Monitoring Board (EMB), blinded to individual participant treatment assignment, determined the occurrence and date of the first treatment failure event. Percentage of participants who experienced treatment failure due to any event and for each specific category of event were assessed.|From date of randomization up to Month 15|eITT population included all ITT participants who had their study assessments for time period between randomization date and eITT end point. The eITT end point for paliperidone palmitate was the last injection date+28 days and for oral antipsychotics was the last prescription date + the number of days’ supply + 1 day.||percentage of participants|||Number
822018|NCT01152385|Secondary|Percentage Change in Triglycerides||from baseline to 4 months|The analysis population was prior to rescue treatment (FAS)||Percentage||Standard Deviation|Mean
821989|NCT01157351|Secondary|Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score During Overall Treatment Duration|The CGI-S rating scale was a 7-point global assessment of symptom severity with scores determined by clinician as follows: 1=Not ill, 2=Very Mild, 3= Mild, 4= Moderate, 5= Marked, 6= Severe, and 7= Extremely Severe. The higher the score the worse the illness.|Baseline up to Month 15|eITT population. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.||Units on a scale||Standard Error|Least Squares Mean
821990|NCT01157351|Secondary|Time to First Psychiatric Hospitalization|A time-to parameter looking only at 1 component event of treatment failure: psychiatric hospitalization. Time to first psychiatric hospitalization was admission date of the psychiatric hospitalization recorded in the “Assessment of Treatment Failure – Psychiatric Hospitalization.”|From date of randomization up to Month 15|eITT population included all ITT participants who had their study assessments for time period between randomization date and eITT end point. The eITT end point for paliperidone palmitate was the last injection date+28 days and for oral antipsychotics was the last prescription date + the number of days’ supply + 1 day.||Days||95% Confidence Interval|Median
821991|NCT01157351|Secondary|Change From Baseline in Personal and Social Performance (PSP) Total Score During Overall Treatment Duration|The PSP score assesses the degree of difficulty a participant exhibit over a 1 month period within 4 domains of behavior: a) socially useful activities, b) personal and social relationships, c) self-care, and d) disturbing and aggressive behavior. The investigators rate participants’ degree of difficulty in each of the 4 domains using a 6-point Likert scale (from 0=absent to 5=very severe). The domain ratings were then transformed to PSP total score ranging from 1 to 100. Higher PSP total scores denote better functioning. A score between 71 and 100 represents normal to mild degree of dysfunction; a score between 31 and 70 represents varying degree of difficulty; and a score <=30 represents poor function that requires intensive supervision.|Baseline up to Month 15|eITT population. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.||Units on a scale||Standard Error|Least Squares Mean
821992|NCT01157351|Secondary|Time to First Psychiatric Hospitalization or Arrest/Incarceration|A time to parameter looking only at 2 component events of treatment failure: arrest or incarceration, and psychiatric hospitalization. An arrest was defined as the taking of a participant into custody by legal authority, for any reason. Incarceration was defined as involuntary confinement by an officer of the law. Psychiatric hospitalization was an inpatient psychiatric hospitalization that occurred due to the participant’s clinically significant worsening of symptoms of schizophrenia.|From date of randomization up to Month 15|eITT population included all ITT participants who had their study assessments for time period between randomization date and eITT end point. The eITT end point for paliperidone palmitate was the last injection date+28 days and for oral antipsychotics was the last prescription date + the number of days’ supply + 1 day.||Days||95% Confidence Interval|Median
821993|NCT01157351|Primary|Time to First Treatment Failure|Time to first treatment failure was the time from participant randomization to the first treatment failure, which was a composite endpoint consisting of any of the following events: arrest/incarceration, psychiatric hospitalization, discontinuation of antipsychotic treatment due to safety or tolerability, treatment supplementation with another antipsychotic due to inadequate efficacy, discontinuation of antipsychotic treatment due to inadequate efficacy, increase in level of psychiatric services to prevent imminent psychiatric hospitalization, suicide. A Treatment Failure Event Monitoring Board (EMB), blinded to individual participant treatment assignment, determined the occurrence and date of the first treatment failure event.|From date of randomization up to Month 15|Explanatory Intent-to-Treat (eITT) population included all ITT participants who had their study assessments for time period between randomization date and eITT end point. The eITT end point for paliperidone palmitate was the last injection date+28 days and for oral antipsychotics was the last prescription date + the number of days’ supply + 1 day.||Days||95% Confidence Interval|Median
821994|NCT01157377|Primary|Change From Baseline in the Daily Average Number of Micturition (Urination) Episodes|The average number of urinary episodes (urination into the toilet) was recorded by a patient bladder diary during 3 consecutive days in the week prior to Baseline and Week 12. A negative change from Baseline indicated improvement (fewer urinary episodes).|Baseline, Week 12|Modified Intent-to-treat population included all randomized participants who received study medication and had post-baseline data available for micturition episodes.||Episodes||Standard Deviation|Mean
821995|NCT01157416|Primary|Child PTSD Symptom Scale (CPSS)|The CPSS is a 17-item standardized, self-administered questionnaires with versions for both youths and caregivers. Items are scored on 0-3 scale. Minimum possible score is 0 and maximum is 51. Only the total score is used; there are no subscales. A higher score indicates greater symptom severity (worse).|After 12 therapy sessions, up to 28 weeks.|||units on a scale||Standard Deviation|Mean
821996|NCT01157429|Primary|Child PTSD Symptom Scale (CPSS)|The CPSS is a 17-item standardized, self-administered questionnaires with versions for both youths and caregivers. Items are scored on 0-3 scale. Minimum possible score is 0 and maximum is 51. Only the total score is used; there are no subscales. A higher score indicates greater symptom severity (worse).|After 12 therapy sessions, up to 28 weeks.|||units on a scale||Standard Deviation|Mean
821997|NCT01157533|Primary|Percent of Participants Attaining Target Trough of 15-20 mg/L Following 30 mg/kg Loading Dose|Peak level (PK blood samples) drawn 4 hours after the completion of loading dose. Sequential trough levels drawn 30 minutes before each standard vancomycin dose for the next 4 doses. PK testing measures the amount of study drug in the body at different time points, with trough testing following 5 doses (1 dose every 8 to 12 hours).|Up to 5 days|Unable to complete analysis planned due to low enrollment.|||||
821998|NCT01157845|Secondary|Liver Transplantation|Patient experiences complications of liver failure within 1 year of study entry and undergoes liver transplantation|1 year|||participants|||Number
821999|NCT01157845|Primary|Mortality From Liver Failure|Patient dies of liver-related causes within 1 year of study entry|1 year|||participants|||Number
822000|NCT01151904|Secondary|Percentage of Responders With an IOP Reduction ≥20% From Baseline|IOP is a measure of the fluid pressure inside the eye. A responder is defined as a patient with a mean IOP reduction of at least 20% in the affected eye(s) from baseline. Due to lack of enrollment, analysis was not performed for this outcome measure.|Baseline, Week 12|Planned analysis population: Intent to Treat: All enrolled patients who received at least 1 dose of study medication, had a valid baseline measurement, and at least one valid post-Day 0 IOP measure. Due to lack of enrollment, analysis was not performed for this outcome measure.|||||
822001|NCT01151904|Secondary|Change From Baseline in IOP|IOP is a measure of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement). Due to lack of enrollment, analysis was not performed for this outcome measure.|Baseline, Week 2, Week 6|Planned analysis population: Intent to Treat: All enrolled patients who received at least 1 dose of study medication, had a valid baseline measurement, and at least one valid post-Day 0 IOP measure. Due to lack of enrollment, analysis was not performed for this outcome measure.|||||
822002|NCT01151904|Primary|Change From Baseline in Intraocular Pressure (IOP)|IOP is a measure of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement). Due to lack of enrollment, analysis was not performed for this outcome measure.|Baseline, Week 12|Planned analysis population: Intent to Treat: All enrolled patients who received at least 1 dose of study medication, had a valid baseline measurement, and at least one valid post-Day 0 IOP measure. Due to lack of enrollment, analysis was not performed for this outcome measure.|||||
822003|NCT01152112|Secondary|Subject Self-reported Pain Score Occurring During the Treatment Procedure|Mean difference in pain score compared between subject-rated assessment of pain occurring during a pap smear and pain occurring during the MyoSure treatment procedure, based on the Wong-Baker Faces Rating Scale (FRS)|1 hour post treatment||||||
822004|NCT01152112|Secondary|Percent of Subjects That Achieve 100% Removal of Target Pathology|Percent volume reduction of target pathology between baseline and month three post treatment assessments, as measured by saline infused sonohysterogram.|Three months post treatment||||||
822005|NCT01152112|Primary|Percent Reduction in Target Pathology Volume|Percent reduction in target pathology volume, compared between pre-treatment baseline and 3 months post MyoSure treatment|Three months post treatment|A total of 108 pathologies were removed in 74 patients. Among the 108 pathologies removed, 53 were removed in the office setting (28 myomas, 25 polyps) and 55 were removed in the ASC setting (14 myomas, 41 polyps).||percentage of fibriods/polyps|Fibroids and Polyps|95% Confidence Interval|Mean
822006|NCT01152190|Secondary|Change From Baseline to 4 and 8 Weeks in Color Pixel Intensity (CPI) in the Prostate Transition Zone, Peripheral Zone, and Bladder Neck|CPI quantified blood flow in a pre-specified region of interest by using color Doppler imaging. CPI was the mean color pixel intensity in the region of interest and scores could range from 0 to 160. An increase in CPI reflected an increase in blood flow. The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included fixed effects for treatment, region, visit, and treatment-by-visit interaction, baseline as a covariate, a random effect of participant within treatment, and an unstructured covariance matrix.|Baseline, Week 4 and Week 8|Randomized participants who received at least 1 dose of study medication.||units on a scale||Standard Error|Least Squares Mean
822007|NCT01152190|Secondary|Change From Baseline to 4 and 8 Weeks in Arterial Resistive Index (RI) in the Prostate Peripheral Zone and Bladder Neck|Arterial RI was a measure of vascular resistance using Doppler ultrasound. RI was the ratio of (peak systolic velocity – end diastolic velocity)/peak systolic velocity, and increased as resistance to flow increased. The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included fixed effects for treatment, region, visit, and treatment-by-visit interaction, baseline as a covariate, a random effect of participant within treatment, and an unstructured covariance matrix.|Baseline, Week 4 and Week 8|Randomized participants who received at least 1 dose of study medication.||ratio||Standard Error|Least Squares Mean
822008|NCT01152190|Secondary|Change From Baseline to 4-Week Endpoint in Arterial Resistive Index (RI) in the Prostate Transition Zone|Arterial RI was a measure of vascular resistance using Doppler ultrasound. RI was the ratio of (peak systolic velocity – end diastolic velocity)/peak systolic velocity, and increased as resistance to flow increased. The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included fixed effects for treatment, region, visit, and treatment-by-visit interaction, baseline as a covariate, a random effect of participant within treatment, and an unstructured covariance matrix.|Baseline, Week 4|Randomized participants who received at least 1 dose of study medication, had non-missing data (arterial RI in the prostate transition zone) at baseline, and a post-baseline visit.||ratio||Standard Error|Least Squares Mean
822009|NCT01152190|Primary|Change From Baseline to 8-Week Endpoint in Arterial Resistive Index (RI) in the Prostate Transition Zone|Arterial RI was a measure of vascular resistance using Doppler ultrasound. RI was the ratio of (peak systolic velocity – end diastolic velocity)/peak systolic velocity, and increased as resistance to blood flow increased. The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included fixed effects for treatment, region, visit, and treatment-by-visit interaction, baseline as a covariate, a random effect of participant within treatment, and an unstructured covariance matrix.|Baseline, Week 8|Randomized participants who received at least 1 dose of study medication, had non-missing data (arterial RI in the prostate transition zone) at baseline, and a post-baseline visit.||ratio||Standard Error|Least Squares Mean
822010|NCT01152294|Secondary|Value Concordance|Measure of how concordant respondents' actual decisions about treatment for their menopause symptoms are with their stated beliefs|2 weeks, on average||||||
822011|NCT01152294|Primary|Menopause Knowledge|Total knowledge score from factual questions about menopause and methods for managing menopause symptoms. Score is the percent of knowledge questions answered correctly (0 - 100%)|2 weeks, on average|Participants were randomized to not receive the decision aid (DVD and booklet)or to receive the decision aid and booklet.||Percentage (0-100%)||Standard Deviation|Mean
822012|NCT01152307|Secondary|Value Concordance|Measure of how concordant respondents' actual decisions about treatment for their depression are with their stated beliefs|2 weeks, on average||||||
822013|NCT01152307|Primary|Depression Knowledge|Total knowledge score from factual questions about depression and methods for managing depression symptoms. Score is the percent of knowledge items answered correctly (0 - 100%).|2 weeks, on average|Participants were randomized to receive the DVD and booklet.||percent of correct responses||Standard Deviation|Mean
822014|NCT01152359|Secondary|Obesity-specific Health-related Quality of Life as Measured by Impact Of Weight On Quality Of Life-Lite (IWQOL-Lite) Questionnaire||48 weeks||||||
822015|NCT01152359|Secondary|Diet Adherence as Measured by Block Food-frequency Questionnaire (Absolute Percentage Deviation From the Goal Macronutrient Intake--<30% Fat for Low-fat Diet or <10% Carbohydrate for Low-carbohydrate Diet)||48 weeks||||||
822016|NCT01152359|Primary|Body Weight||48 weeks|||percentage of weight change||95% Confidence Interval|Mean
822026|NCT01152437|Secondary|Overall Survival (OS) Time|OS time is defined as time from the date of randomisation (wild-type group) or date of start of treatment (mutated group) to the date of death. Median and confidence interval estimated using product-limit Kaplan-Meier method.|Baseline till death, assessed up to 23 months|Randomised set for wild-type group and treated set for mutated group.||Days||95% Confidence Interval|Median
822027|NCT01152437|Secondary|Progression Free Survival (PFS)|PFS time is defined as time from randomisation (wild-type group) or start of treatment (mutated group) to tumor progression evaluated according to RECIST (version 1.1) or death whichever occurs earlier. Median and confidence interval estimated using product-limit Kaplan-Meier method.|Baseline till progression or death, whichever came first, assessed up to 23 months|Randomised set for wild-type group and treated set for mutated group.||Days||95% Confidence Interval|Median
822028|NCT01152437|Primary|Percentage of Participants With Disease Control (DC)|Percentage of participants with objective response or stable disease (SD) as determined by RECIST (version 1.1) with confirmation criteria applied.|Baseline till progression or death, whichever came first, assessed up to 23 months|Treated Set. Primary endpoint for the population of patients with KRAS mutated tumours.||Percentage of Participants||90% Confidence Interval|Number
822029|NCT01152437|Primary|Percentage of Participants With Objective Response|Percentage of participants with objective response: complete response (CR) or partial response (PR) according to RECIST (version 1.1) without confirmation criteria applied.|Baseline till progression or death, whichever came first, assessed up to 23 months|Randomised set. Primary endpoint for the population of patients with KRAS wildtype tumours.||Percentage of Participants|||Number
822030|NCT01152450|Secondary|Mean Number of Night Awakenings During the Last Week on Treatment (Score, Response Values)|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Assessed by the patient's electronic diary (eDiary incorporated in the AM2+ device), obtained during the last week of each period of randomised treatment.|Baseline and during week 4|FAS||Night awakenings||Standard Error|Mean
822031|NCT01152450|Secondary|Mean Number of Puffs of Rescue Medication During Nighttime (Last Week on Treatment, Response Values)|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Weekly means obtained during the last week of each period of randomised treatment will be compared.|Baseline and during week 4|FAS||Puffs||Standard Error|Mean
822032|NCT01152450|Secondary|Mean Number of Puffs of Rescue Medication During Daytime (Last Week on Treatment, Response Values)|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Weekly means obtained during the last week of each period of randomised treatment will be compared.|Baseline and during week 4|FAS||Puffs||Standard Error|Mean
822033|NCT01152450|Secondary|Mean Number of Puffs of Rescue Medication During the Whole Day (Last Week on Treatment, Response Values)|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Weekly means obtained during the last week of each period of randomised treatment will be compared.|Baseline and during week 4|FAS||Puffs||Standard Error|Mean
822034|NCT01152450|Secondary|PEF Variability Response (Last Week on Treatment)|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. PEF variability is the absolute difference between morning and evening PEF value divided by the mean of these two values, expressed as a percent (weekly means obtained during the last week of each period of randomised treatment will be compared).|Baseline and during week 4|FAS||Percent||Standard Error|Mean
822035|NCT01152450|Secondary|PEF Area Under the Curve 0-24 Hours (AUC0-24h) Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. AUC0-24h calculated using the trapezoidal rule divided by the observation time (24 hours) to report in litres/min.|10 min prior to first dose (baseline) and -10 min, 30 min, 60 min, 2 h, 3 h, 4 h , 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose at week 4|FAS||L/min||Standard Error|Mean
822036|NCT01152450|Secondary|FVC Area Under the Curve 0-24 Hours (AUC0-24h) Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. AUC0-24h calculated using the trapezoidal rule divided by the observation time (24 hours) to report in litres.|10 min prior to first dose (baseline) and -10 min, 30 min, 60 min, 2 h, 3 h, 4 h , 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose at week 4|FAS||L||Standard Error|Mean
822037|NCT01152450|Secondary|Individual Peak Expiratory Flow (PEF) Over Time (at Each Timepoint at Visits) Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline.|Baseline and 4 weeks|FAS||L/min||Standard Error|Mean
822038|NCT01152450|Secondary|Individual FVC Over Time (at Each Timepoint at Visits) Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline.|Baseline and 4 weeks|FAS||L||Standard Error|Mean
822039|NCT01152450|Secondary|Individual FEV1 Over Time (at Each Timepoint at Visits) Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline.|Baseline and 4 weeks|FAS||L||Standard Error|Mean
822040|NCT01152450|Secondary|Peak FVC Within 24 Hours Post-dose Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Measured following each dosing determined at the end of each 4 week treatment period.|Baseline and 4 weeks|FAS||L||Standard Error|Mean
822041|NCT01152450|Secondary|FVC Area Under the Curve 12-24 Hours (AUC12-24h) Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Measured following each dosing determined at the end of each 4 week treatment period. AUC12-24h calculated using the trapezoidal rule divided by the observation time (12 hours) to report in litres.|10 min prior to first dose (baseline) and 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose at week 4|FAS||L||Standard Error|Mean
822077|NCT01158118|Secondary|Number of Donors Who Mobilize ≥ 2x10^6 CD34+ Cells/Kg Recipient Weight Safely Following One or Two Aphereses|-The donor will undergo a leukapheresis procedure to process 20L of blood volume. After the procedure, the collection will be analyzed to look at CD34+ cell content. If it contains at least 2x10^6 CD34+ cells/kg, then the procedure will be considered successful.|Up to 6 days|||Participants|||Count of Participants
822042|NCT01152450|Secondary|FVC Area Under the Curve 0-12 Hours (AUC0-12h) Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Measured following each dosing determined at the end of each 4 week treatment period. AUC0-12h calculated using the trapezoidal rule divided by the observation time (12 hours) to report in litres.|10 min prior to first dose (baseline) and -10 min, 30 min, 60 min, 2 h, 3 h, 4 h and 11 h 50 min related to evening dose at week 4|FAS||L||Standard Error|Mean
822043|NCT01152450|Secondary|Trough Forced Vital Capacity (FVC) Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Trough FVC is defined as FVC value (performed at 10 minutes prior to the evening trial-drug inhalation) at the end of each 4 week period of randomised treatment.|Baseline and 4 weeks|FAS||L||Standard Error|Mean
822044|NCT01152450|Secondary|Trough FEV1 Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Trough FEV1 is defined as FEV1 value (performed at 10 minutes prior to the evening trial-drug inhalation) at the end of each 4 week period of randomised treatment.|Baseline and 4 weeks|FAS||L||Standard Error|Mean
822045|NCT01152450|Secondary|Peak FEV1 Within 24 Hours Post-dose Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Measured following the evening trial-drug inhalation at the end of each 4 week period of randomised treatment.|Baseline and 4 weeks|FAS||L||Standard Error|Mean
822046|NCT01152450|Secondary|FEV1 Area Under the Curve 12-24 Hours (AUC12-24h) Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Measured following the respective dosing determined at the end of each 4 week period of randomised treatment. AUC12-24h calculated using the trapezoidal rule divided by the observation time (12 hours) to report in litres.|10 min prior to first dose (baseline) and 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose at week 4|FAS||L||Standard Error|Mean
822047|NCT01152450|Secondary|FEV1 Area Under the Curve 0-12 Hours (AUC0-12h) Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Measured following the respective dosing determined at the end of each 4 week period of randomised treatment. AUC0-12h calculated using the trapezoidal rule divided by the observation time (12 hours) to report in litres.|10 min prior to first dose (baseline) and -10 min, 30 min, 60 min, 2 h, 3 h, 4 h and 11 h 50 min related to evening dose at week 4|FAS||L||Standard Error|Mean
822048|NCT01152450|Secondary|Mean Pre-dose Evening Peak Expiratory Flow (PEF p.m.) Response During the Last Week on Treatment|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Measured by patients at home using the AM2+ device.|Baseline and during week 4 of each treatment period|FAS||L/min||Standard Error|Mean
822049|NCT01152450|Secondary|Mean Pre-dose Morning Peak Expiratory Flow (PEF a.m.) Response During the Last Week on Treatment|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Measured by patients at home using the AM2+ device.|Baseline and during week 4 of each treatment period|FAS||L/min||Standard Error|Mean
822050|NCT01152450|Primary|Forced Expiratory Volume in One Second (FEV1) Area Under the Curve 0-24 Hours (AUC0-24h) Response|Mixed Model Repeated Measure (MMRM) results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Measurements performed in relation to evening dosing. AUC0-24h calculated using the trapezoidal rule divided by the observation time (24 hours) to report in litres.|10 minutes (min) prior to first dose (baseline) and -10 min, 30 min, 60 min, 2 hours (h) , 3 h, 4 h , 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose at week 4|Full Analysis Set (FAS) defined as all treated patients who had baseline data and at least 1 on-treatment efficacy measurement after 4 weeks on treatment within a period.||L||Standard Error|Mean
822051|NCT01152554|Secondary|Change in EuroQol - 5 Dimensions (EQ-5D) From Randomization (Week 0) to End of Treatment (Week 52)|A self-assessment questionnaire that provides 2 measures of health status. The EQ-5D index score is a weighted linear combination over 5 dimensions of health status. The score for each of the 5 dimensions can range from 1 to 3, and an equation is used to calculate the EQ-5D index score. The EQ-5D index score can range from possible negative values to a maximum of 1.0. The EQ-VAS is a visual analog scale with a range of 0 to 100. For both variables, a higher score indicates a better health state.|Randomization (Week 0) to end of treatment (Week 52)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a total MADRS score at randomization and a total HAMD-17 score ≥16 and a CGI-S score ≥4 at randomization.||units on a scale||Standard Deviation|Mean
822052|NCT01152554|Secondary|Change in Overall Quality of Life and Satisfaction From Randomization (Week 0) to End of Treatment (Week 52) by Assessing the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) % Maximum Total Score|The Q-LES-Q-SF total score is derived by summing item scores 1 to 14. Higher scores are indicative of greater enjoyment or satisfaction in each domain. The Q-LES-Q-SF % maximum total score is calculated as 100% × (Q-LES-Q-SF total score – 14) / 56, and can range from 0% to 100%.|Randomization (Week 0) to end of treatment (Week 52)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a total MADRS score at randomization and a total HAMD-17 score ≥16 and a CGI-S score ≥4 at randomization.||units on a scale||Standard Deviation|Mean
822053|NCT01152554|Secondary|Change in Functional Impairment From Randomization (Week 0) to End of Treatment (Week 52) as Measured by the Sheehan Disability Scale (SDS) Total Score|Sheehan Disability Scale (SDS) is 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The SDS total score is calculated as the sum of the score for the 3 inter-correlated domains (school/work, social life, and family life/home responsibilities) and ranges from 0 (unimpaired) to 30 (highly impaired).|Randomization (Week 0) to end of treatment (Week 52)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a total MADRS score at randomization and a total HAMD-17 score ≥16 and a CGI-S score ≥4 at randomization.||units on a scale||Standard Deviation|Mean
822054|NCT01152554|Secondary|Change in the Clinician-rated Global Outcome of Severity as Measured by the Clinical Global Impression-Severity (CGI-S) Score From Randomization (Week 0) to End of Treatment (Week 52)|A 3-part, clinician-administered scale that rates the improvement or worsening of the patient’s illness from randomization (baseline). Each item is scored on a 1 to 7 scale. Higher CGI-S scores indicate greater illness severity.|Randomization (Week 0) to end of treatment (Week 52)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a total MADRS score at randomization and a total HAMD-17 score ≥16 and a CGI-S score ≥4 at randomization.||units on a scale||Standard Deviation|Mean
822055|NCT01152554|Secondary|Sustained Efficacy at 9 Months, Defined as a MADRS Total Score of ≤12 at Week 12 and at All Visits up to and Including Week 52|"The percentage of patients with a MADRS total score of ≤12 at Week 12 and at all visits up to and including Week 52 was calculated. Two intermediate occurrences (not consecutive) of a MADRS >12 but ≤16 or missing were allowed from Week 16 to Week 48.
A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Week 12 to Week 52|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a total MADRS score at randomization and a total HAMD-17 score ≥16 and a CGI-S score ≥4 at randomization.||percentage of patients analyzed|||Number
822056|NCT01152554|Secondary|Sustained Efficacy at 3 Months, Defined as a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of ≤12 at Week 12 and All Visits up to and Including Week 24|"The percentage of patients with a a MADRS total score of ≤12 at Week 12 and all visits up to and including Week 24 was calculated. One intermediate occurrence of a MADRS total score >12 but ≤16 or missing was allowed from Week 16 to Week 20.
A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Week 12 to Week 24|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a total MADRS score at randomization and a total HAMD-17 score ≥16 and a CGI-S score ≥4 at randomization.||percentage of participants analyzed|||Number
822057|NCT01152554|Primary|Frequency of Patients Experiencing Serious Adverse Events (SAEs)|The frequency of patients experiencing serious adverse events (SAEs) during the randomized treatment or follow-up periods was calculated.|Randomization (Week 0) to end of the follow-up period (Week 54)|Safety analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and for whom any postdose data were available.||percentage of participants analyzed|||Number
822058|NCT01152554|Primary|Frequency of Patients Experiencing AEs That Resulted in Discontinuation of Investigational Product (IP)|The frequency of patients experiencing AEs that resulted in discontinuation of IP during the randomized treatment or follow-up periods was calculated.|Randomization (Week 0) to end of the follow-up period (Week 54)|Safety analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and for whom any postdose data were available.||percentage of participants analyzed|||Number
822059|NCT01152554|Primary|Frequency of Patients Experiencing at Least One Adverse Event (AE)|The frequency of patients experiencing at least one AE during the randomized treatment or follow-up periods was calculated.|Randomization (Week 0) to end of the follow-up period (Week 54)|Safety analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and for whom any postdose data were available.||percentage of participants analyzed|||Number
822060|NCT01152580|Secondary|The Effect of Melatonin (3 mg) or Placebo on the Mean Change in the Pittsburgh Sleep Quality Index (PSQI) in Women After 6 Months, as Compared to Baseline.|"Pittsburgh Sleep Quality Index (PSQI) Questionnaire is a validated questionnaire that assesses the quality and quantity of sleep and sleep disorders.This survey is designed to identify “good” and “poor” sleepers and has a score scale that ranges from 0-21 with 0 being good quality of sleep and 21 being poor quality of sleep and/or indicating as having a sleep disorder. A more positive mean change in the PSQI over time indicates a worsening of sleep. A more negative mean change in the PSQI over time indicates an improvement in sleep."|Baseline and 6 months|intention to treat||units on a scale||Standard Deviation|Mean
822061|NCT01152580|Secondary|The Effect of Melatonin (3 mg) or Placebo on the Mean Change in Menopause-Specific Quality of Life (MENQOL) Sexual Domain Scores in Women After 6 Months, as Compared to Baseline.|"Menopause-Specific Quality of Life (MENQOL) questionnaires were administered to women at baseline and after 6 months of taking placebo or melatonin nightly. The MENQOL is a validated questionnaire that measures 4 domains of menopause quality of life in women: physical, vasomotor, psychosocial and sexual with each domain having a scale of not bothered (score 0) or bothered ranging from 1(not too bothered) to 6 (really bothered). A more negative mean change for each of the MENQOL domain scores indicates an improvement of these symptoms and a more positive value a worsening of symptoms."|Baseline and 6 mos|intention to treat||units on a scale||Standard Deviation|Mean
822062|NCT01152580|Primary|The Effect of Melatonin (3 mg) or Placebo on the Mean Change in Bone Density in Women After 6 Months, as Compared to Baseline.|The mean change in bone mineral density (BMD), represented by T-scores, was assessed by calcaneal ultrasound in women taking melatonin (3 mg) or placebo nightly at baseline and after 6 months. A T-score is a comparison of a subject's BMD to that of a healthy 30 year old female of the same ethnicity. The more negative the T-score, the worse the BMD. Osteoporosis or brittle bone disease is defined as a T-score -2.5 or less. A more negative mean change in a T-score would indicate a worsening of BMD. A more positive mean change in a T-score would indicate an improvement of BMD.|Baseline and 6 months|intention to treat||T-score||Standard Deviation|Mean
822076|NCT01158118|Secondary|Percentage of Donors Who Reach 5x10^6 CD34+ Cells/Kg Recipient Weight in 1 or 2 Aphereses|-The donor will undergo a leukapheresis procedure to process 20L of blood volume. After the procedure, the collection will be analyzed to look at CD34+ cell content. The percentage of donors who reach at least 5x10^6 CD34+ cells/Kg recipient weight will be analyzed for this outcome measure.|6 days|-If patients achieved ≥ 2x10^6 CD34+ cells/Kg, they were not required to go on to a second day of collection||Participants|||Count of Participants
822063|NCT01152580|Secondary|The Effect of Melatonin (3 mg) or Placebo on the Mean Change in Menopause-Specific Quality of Life (MENQOL) Psychosocial Domain Scores in Women After 6 Months, as Compared to Baseline.|"Menopause-Specific Quality of Life (MENQOL) questionnaires were administered to women at baseline and after 6 months of taking placebo or melatonin nightly. The MENQOL is a validated questionnaire that measures 4 domains of menopause quality of life in women: physical, vasomotor, psychosocial and sexual with each domain having a scale of not bothered (score 0) or bothered ranging from 1(not too bothered) to 6 (really bothered). A more negative mean change for each of the MENQOL domain scores indicates an improvement of these symptoms and a more positive value a worsening of symptoms."|Baseline and 6 mos|intention to treat||units on a scale||Standard Deviation|Mean
822064|NCT01152580|Primary|The Effect of Melatonin (3 mg) or Placebo on the Mean Change in Serum Type-1 Collagen Cross-linked N-telopeptide (NTX) Levels in Women After 6 Months, as Compared to Baseline.|Type-1 collagen cross-linked N-telopeptide (NTX) levels were measured in the serum of women at baseline and after taking placebo or melatonin (3 mg) nightly for 6 months. NTX, reported as bone collagen equivalents (BCE), is released from bone due to the actions of osteoclasts or bone breakdown cells. A more positive mean change in NTX levels (6 months - baseline) could result in a worsening of bone mineral density due to an increase in bone breakdown whereas a more negative mean change in NTX levels could result in an improvement in bone mineral density due to a decrease in bone breakdown.|Baseline and 6 months|intention to treat||nM BCE||Standard Deviation|Mean
822065|NCT01152580|Secondary|The Effect of Melatonin (3 mg) or Placebo on the Mean Change in Menopause-Specific Quality of Life (MENQOL) Vasomotor Domain Scores in Women After 6 Months, as Compared to Baseline.|"Menopause-Specific Quality of Life (MENQOL) questionnaires were administered to women at baseline and after 6 months of taking placebo or melatonin nightly. The MENQOL is a validated questionnaire that measures 4 domains of menopause quality of life in women: physical, vasomotor, psychosocial and sexual with each domain having a scale of not bothered (score 0) or bothered ranging from 1(not too bothered) to 6 (really bothered). A more negative mean change for each of the MENQOL domain scores indicates an improvement of these symptoms and a more positive value a worsening of symptoms."|Baseline and 6 mos|intention to treat||units on a scale||Standard Deviation|Mean
822066|NCT01152580|Secondary|The Effect of Melatonin (3 mg) or Placebo on the Mean Change in Menopause-Specific Quality of Life (MENQOL) Physical Domain Scores in Women After 6 Months, as Compared to Baseline.|"Menopause-Specific Quality of Life (MENQOL) questionnaires were administered to women at baseline and after 6 months of taking placebo or melatonin nightly. The MENQOL is a validated questionnaire that measures 4 domains of menopause quality of life in women: physical, vasomotor, psychosocial and sexual with each domain having a scale of not bothered (score 0) or bothered ranging from 1(not too bothered) to 6 (really bothered). A more negative mean change for each of the MENQOL domain scores indicates an improvement of these symptoms and a more positive value a worsening of symptoms."|Baseline and 6 mos|intention to treat||units on a scale||Standard Deviation|Mean
822067|NCT01152580|Primary|The Effect of Melatonin (3 mg) or Placebo on the Mean Change in Serum Osteocalcin (OC) Levels in Women After 6 Months, as Compared to Baseline|Osteocalcin is a measure of osteoblast activity because it is secreted from osteoblasts. Osteocalcin levels were measured in the serum of women at baseline and after 6 months of taking placebo or melatonin (3 mg) and the data are reported as ng/mL. Osteoblasts are bone-forming cells so a more positive mean change in osteoblast activity over time (6 months - baseline) could indicate an improvement in bone mineral density. A more negative mean change in osteocalcin levels over time (6 months - baseline) could indicate a worsening of bone mineral density.|Baseline and 6 months|intention to treat||ng/mL||Standard Deviation|Mean
822068|NCT01158118|Secondary|Death of Any Cause (Recipients Only)||Up to 1 year|||Participants|||Count of Participants
822069|NCT01158118|Secondary|Relapse and Disease Progression Rate|-A patient will be considered relapsed (disease progressed) when there is a recurrence of the original malignant disease after transplantation.|Up to 1 year|||Participants|||Count of Participants
822070|NCT01158118|Secondary|Transplant Related Mortality (Recipient Only)|Death that results from a transplant procedure related complication (e.g. infection, organ failure, hemorrhage, GVHD) rather than from relapse of the underlying disease or an unrelated cause.|100 days|||Participants|||Count of Participants
822071|NCT01158118|Secondary|Rate of Chronic Graft vs. Host Disease (GvHD) (Recipient Only)|Incidence and severity of chronic GVHD will be assessed based on the NIH consensus criteria and global severity scoring system. Attempts should be made to confirm the diagnosis pathologically by biopsy of target organ(s).|Day 100-1 year|6 participants are not evaluable for this outcome measure as they came off study prior to the start of chronic GvHD assessments.||Participants|||Count of Participants
822072|NCT01158118|Secondary|Rate of Acute Graft vs. Host Disease (GvHD) (Recipient Only)|-Incidence and severity of acute GVHD will be assessed based on the Seattle criteria. Attempts should be made to confirm the diagnosis pathologically by biopsy of target organ(s).|Up through Day 100|3 of the recipients received cells mobilized by 10 mcg/kg of GM-CSF and the 11 recipients received stem cells from donors mobilized with the decreased dose of 5 mcg/kg of GM-CSF.||Participants|||Count of Participants
822073|NCT01158118|Secondary|Kinetics of Immune Reconstitution as Measured by Time to Platelet Engraftment (Recipient Only)|-Time to platelet engraftment is measured by determining the first of 3 consecutive measurements of platelet count ≥ 20,000/ul without platelet transfusion support for 7 days.|Up to Day 180|1 recipient did not have platelet engraftment by Day 180 and is not evaluable for this outcome measure.||days||Full Range|Median
822074|NCT01158118|Secondary|Kinetics of Immune Reconstitution as Measured by Time to Neutrophil Engraftment (Recipient Only)|-Time to neutrophil engraftment is measured by determining the first of 3 consecutive measurements of neutrophil count ≥ 500/ul following conditioning regimen induced nadir.|Up to Day 100|||days||Full Range|Median
822075|NCT01158118|Secondary|Determine if Peripheral Blood Stem Cell Products Collected After Mobilization With IV Plerixafor Can be Used Safely for Hematopoietic Cell Transplantation in HLA-matched Recipients as Measured by Time to Neutrophil Engraftment (Recipient Only)|-Time to neutrophil engraftment is measured by determining the first of 3 consecutive measurements of neutrophil count ≥ 500/ul following conditioning regimen induced nadir.|Up to Day 21|||Participants|||Count of Participants
822107|NCT01160614|Primary|Single- and Multiple-dose PK Metric: Lag Time Estimated as the Time Point Immediately Prior to the First Measurable Plasma Concentration Value From Hour 0 to 12 Hours of the First Dose of ORF (Tlag 0-12)|Due to insufficient sampling, tlag 0-12 was not estimated.|Up to 12 hours||||||
822078|NCT01158118|Secondary|Proportion of Donors Who Experience Grade 3-4 Infusion Toxicity|Infusional toxicity will be evaluated by measuring the patient’s blood pressure, heart rate, respirations and temperature one hour prior to the allograft infusion and then 15 minutes, 30 minutes, one hour, 2 hours, and 4 hours, and 6 hours post infusion. Donors will have vital signs collected at each time point. EKGs will be performed immediately prior to IV AMD3100 and one hour after infusion.|30 days after completion of therapy (estimated to be 36 days)|||Participants|||Count of Participants
822079|NCT01158118|Primary|Number of Donors Requiring a Second Collection to Obtain a Minimum CD34/Kg (2 x 10^6) Necessary for Allogeneic Stem Cell Transplantation|The primary endpoint is to reduce the number of donors treated with GM-CSF who require a second collection to obtain a minimum CD34/Kg (2 x 106) necessary for allogeneic stem cell transplantation when compared to historic controls mobilized with GM-CSF or plerixafor alone. A reduction in failed first leukapheresis from 40% to less than 10% as seen with G-CSF alone would be considered clinically meaningful.|Up to 6 days|||Participants|||Count of Participants
822080|NCT01158261|Primary|Specific Safety Parameters|"Incidence of graft occlusion
Incidence of adverse events potentially related to non-graft thrombotic events
Incidence of bleeding events"|Up to 4-weeks post-operatively|From participant flow, 283 subjects completed the study; One subject lost to follow-up had 4-week information in hospital records.||participants|||Number
822081|NCT01158378|Secondary|Proportion of Subjects Free of Device-related Surgical Wound Infections or Meningitis During 120-day Follow-up.|Device-related surgical wound infections included all infections classified by the CEC as definitely, probably, possibly or undetermined in relation to the device.|120 days|Includes all subjects with available data that through 120 days follow-up.||percentage of subjects|||Number
822082|NCT01158378|Post-Hoc|Proportion of Treated Subjects Who Were Free of Intra-operative Cerebrospinal Fluid (CSF) Leakage From Dural Repair During Valsalva Maneuver, CSF Leak / Pseudomeningocele, and Unplanned Retreatment of the Original Surgical Site|"Post-Hoc analysis of primary composite endpoint of the safety and effectiveness of Adherus for a cranial application at 45 days. The endpoint was measured by the proportion of treated subjects who were free of all of the following incidences:
Intra-operative CSF leakage from dural repair after up to two Adherus / control applications during Valsalva maneuver up to 20cm H2O for up to 5 seconds.
CSF leak or pseudomeningocele diagnosed by physical examination, biochemical assay or imaging study during the 120-day follow-up period of the index procedure
Unplanned retreatment of the original surgical site adjudicated by the CEC to be device-related, including meningitis or the management of deep infection, minimally invasive procedures or return to the operating room for neurosurgical complications other than CSF leak or pseudomeningocele formation or those related to the subject’s pre-existing condition, during the 120-day follow-up period."|45 days|All subjects who received treatment with evaluable 45-day follow-up data.||percentage of subjects||95% Confidence Interval|Number
822083|NCT01158378|Post-Hoc|Proportion of Treated Subjects Who Were Free of Intra-operative Cerebrospinal Fluid (CSF) Leakage From Dural Repair During Valsalva Maneuver, CSF Leak / Pseudomeningocele, and Unplanned Retreatment of the Original Surgical Site|"Post-Hoc analysis of primary composite endpoint of the safety and effectiveness of Adherus for a cranial application at 14 days. The endpoint was measured by the proportion of treated subjects who were free of all of the following incidences:
Intra-operative CSF leakage from dural repair after up to two Adherus / control applications during Valsalva maneuver up to 20cm H2O for up to 5 seconds.
CSF leak or pseudomeningocele diagnosed by physical examination, biochemical assay or imaging study during the 120-day follow-up period of the index procedure
Unplanned retreatment of the original surgical site adjudicated by the CEC to be device-related, including meningitis or the management of deep infection, minimally invasive procedures or return to the operating room for neurosurgical complications other than CSF leak or pseudomeningocele formation or those related to the subject’s pre-existing condition, during the 120-day follow-up period."|14 days|All subjects who received treatment with evaluable 14-day follow-up data.||percentage of subjects||95% Confidence Interval|Number
822084|NCT01158378|Primary|Proportion of Treated Subjects Who Were Free of Intra-operative Cerebrospinal Fluid (CSF) Leakage From Dural Repair During Valsalva Maneuver, CSF Leak / Pseudomeningocele, and Unplanned Retreatment of the Original Surgical Site|"The primary endpoint was a composite evaluation of the safety and effectiveness of Adherus for a cranial application. The endpoint was measured by the proportion of treated subjects who were free of all of the following incidences:
Intra-operative CSF leakage from dural repair after up to two Adherus / control applications during Valsalva maneuver up to 20cm H2O for up to 5 seconds.
CSF leak or pseudomeningocele diagnosed by physical examination, biochemical assay or imaging study during the 120-day follow-up period of the index procedure
Unplanned retreatment of the original surgical site adjudicated by the CEC to be device-related, including meningitis or the management of deep infection, minimally invasive procedures or return to the operating room for neurosurgical complications other than CSF leak or pseudomeningocele formation or those related to the subject’s pre-existing condition, during the 120-day follow-up period."|120 days|All subjects who received treatment with evaluable 120-day follow-up data.||percentage of subjects||95% Confidence Interval|Number
822085|NCT01160380|Secondary|Epworth Sleepiness Scale (ESS) Score|Survey assessing sleep patterns. The test consists of 8 items. The response scale range is 0-24 (range 0-3 per item: 0-No chance to falling asleep; 3-high chance of falling asleep). Interpretation: 0-No chance to falling asleep; 10+ above average chance daytime sleepiness|Day 1, Day 28 and Day 56|||units on a scale||Standard Deviation|Mean
822086|NCT01160380|Secondary|Hospital Anxiety and Depression Scale (HADS) Score|Survey used to assess depression and anxiety. The test consists of 14 items (7 for anxiety and 7 for depression); there are 4 possible answers for each statement. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. Higher scores= more anxiety or depression.|Day 1, Day 28 and Day 56|||units on a scale||Standard Error|Mean
822087|NCT01160380|Secondary|Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score|Survey addressing fatigue and patient happiness, coping, etc. Used to assess quality of life. The test consists of 40 items, each item with a response scale of 0-4. Higher scores denote better status Items are added to provide the total score (range 0-160).|Day 1, Day 28 and Day 56|||units on a scale||Standard Deviation|Mean
822088|NCT01160380|Primary|Digit Span Test Score|Test evaluates working memory and attention. The test consists of repeat numeric sequences of 2 to 9 numbers forward or backwards and evaluates the number of items from a sequence correctly named. Higher scores = better performance.|Day 1, Day 28 and Day 56|||Number of correct items||Standard Deviation|Mean
822089|NCT01160380|Primary|Symbol Digit Modalities Test Score (SDMT)|Test to evaluate neurocognitive functions (attention, visual scanning and motor speed). The test consists of a key =9 graphic symbols numbered 1 to 9 and the test =120 graphic symbols to be matched with its number. The test evaluates the number of correct matches within 90 seconds. Higher scores= better performance|Day 1, Day 28 and Day 56|||Number of correct matches||Standard Deviation|Mean
822090|NCT01160380|Primary|Trail Making Test B Score (TMT-B)|"Cognitive test that gives a measure of various aspects of cognitive performance. Used to measure cognitive fatigue. The test consists of 25 circles containing 13 sequential numbers (1-13) and 12 sequential letters (A-L) positioned.
The test evaluates the time to correctly order letters and numbers; low times = better performance."|Day 1, Day 28 and Day 56|||seconds||Standard Deviation|Mean
822091|NCT01160380|Primary|BFI Score|Survey measuring fatigue. The scale contains 9 items; range=0-90 (0-10 per item). Mild = 1-3 Moderate = 4-7 Severe = 8-10|Day 1, Day 28 and Day 56|||units on a scale||Standard Deviation|Mean
822092|NCT01160445|Secondary|Toxicity of Zanolimumab and IL-2 Treatment Regimen|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|10 months|||Participants|||Number
822093|NCT01160445|Primary|The Ability of a Combination of Aldesleukin (IL-2) and Zanolimumab (Anti-CD4 mAb) Administration to Mediate Tumor Regression in Patients With Metastatic Melanoma and Metastatic Kidney Cancer.|Tumor regression was assessed by the Response Criteria in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% in the sum of the longest diameter (LD) recorded since the treatment started. Stable disease (SD) is neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for PD taking as reference the smallest sum LD.|2 years|||Participants|||Number
822094|NCT01160458|Secondary|Overall Survival (OS)|Overall survival is the time interval from the start of treatment to the date of death.|To study completion, an average of 3 years|One participant withdrew from the study and was excluded from the analysis.||Months||95% Confidence Interval|Median
822095|NCT01160458|Secondary|Progression Free Survival (PFS)|Progression Free Survival is defined as the time interval from the start of treatment to documented evidence of disease progression. Progressive disease is at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum on study longest diameter (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. (Note: the appearance of one or more new lesions is also considered progression).|To study completion, an average of 3 years|One participant withdrew from the study and was excluded from the analysis.||months||95% Confidence Interval|Median
822096|NCT01160458|Secondary|Duration of Overall Response|Duration of Overall Response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) and is measured from the time measurement criteria are met for complete response (CR) or partial response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Complete response is complete disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease is at least a 20% increase in the sum of the longest diameter of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. (Note: the appearance of one or more new lesions is also considered progression).|36 months|No participants had a complete response or partial response.|||||
822097|NCT01160458|Secondary|Safety of IMC-A12 in Patients With Mesothelioma|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|36 months|||Participants|||Number
822098|NCT01160458|Primary|Clinical Response Rate (PR+CR)|Clinical response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is complete disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|36 months|||Participants|||Number
822099|NCT01160484|Secondary|Follow-up Time|time that patients were monitored for disease progression and overall survival|Follow-up visits for disease progression and overall survival every 3 months after study discontinuation. After progression, follow-up visits for survival status every 6 months or until alternate therapy needs to be started or death intervenes|||months||Full Range|Median
822100|NCT01160484|Secondary|Progression-free Survival||Time from the start of treatment to progressive disease or until death|||months||Full Range|Median
822101|NCT01160484|Secondary|Time to Progression||Time from the start of treatment to progressive disease|||months||Full Range|Median
822102|NCT01160484|Secondary|Duration of Response||First evidence of PR or better (for overall response) and MR or better (for clinical benefit response) to start of disease progression or death.|||months||Full Range|Median
822103|NCT01160484|Secondary|Time to Best Response||Up to 7.5 months (eight 28-day cycles)|||months||Full Range|Median
822104|NCT01160484|Secondary|Time to First Response||Up to 7.5 months (eight 28-day cycles)|||months||Full Range|Median
822105|NCT01160484|Primary|International Myeloma Working Group (IMWG) Response Criteria|The investigator will evaluate each patient for response to therapy according to criteria augmented from those developed by Bladé et al., 1998 presented below (Table 7-1). Assessment of disease response will be performed prior to drug administration on Day 1 of Cycles 2 8 and at the End of Study Treatment visit. If a patient is determined to have complete response (CR), very good partial response (VGPR), partial response (PR), or minor response (MR), then assessment of disease response is to be performed 4 weeks later to confirm the response.|Up to 7.5 months (eight 28-day cycles)|Population analysis was carried out as per protocol. Efficacy was evaluated via a modified version of the Bladé response criteria [complete response (CR), very good partial response (VGPR), partial response (PR), and those achieving minimal response (MR)]||participants|||Number
822106|NCT01160614|Primary|The Number of Patients With Adverse Events as a Measure of Safety||Adverse events (AEs) & serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion (AEs) & through 30 days following last study drug dose, or until last study visit, whichever was later (SAEs).|The safety population (N = 30) was defined as the group of patients who received study drug||participants|||Number
822110|NCT01160614|Primary|Single- and Multiple-dose PK Metric: Mean Area Under the Plasma Concentration During Each Dosing Interval-time Curve From Hour 0 to 12 Hours of the First Dose of ORF (AUC 0-12)||Up to 12 hours|The full analysis population for PK (N = 30) was defined as patients who received at least 1 dose of oral study drug and had at least 1 valid quantifiable PK metric||ng*h/mL||Standard Deviation|Mean
822111|NCT01160614|Primary|Single-dose PK Metric: Lag Time Was Estimated as the Time Point Immediately Prior to the First Measurable Plasma Concentration Value (Tlag)|Due to insufficient sampling, tlag was not estimated.|Up to 24 hours||||||
822112|NCT01160614|Primary|Single-dose PK Metric: Apparent Plasma Terminal Phase Half/Life (t1/2z)|Due to insufficient sampling, t1/2z was not estimated.|Up to 24 hours||||||
822113|NCT01160614|Primary|Single-dose PK Metric: Apparent Terminal Phase Rate Constant (Lamda z)|Due to insufficient sampling, Lamda z was not estimated.|Up to 24 hours||||||
822114|NCT01160614|Primary|Single-dose PK Metric: Time to Maximum Plasma Concentration (Tmax)||Up to 24 hours|The full analysis population for PK (N = 30) was defined as patients who received at least 1 dose of oral study drug and had at least 1 valid quantifiable PK metric||hour (h)||Full Range|Median
822115|NCT01160614|Primary|Single-dose PK Metric: Maximum Observed Plasma Concentration (Cmax)||Up to 24 hours|The full analysis population for PK (N = 30) was defined as patients who received at least 1 dose of oral study drug and had at least 1 valid quantifiable PK metric||ng/mL||Standard Deviation|Mean
822116|NCT01160614|Secondary|Multiple-dose PK Metric: Minimum Observed Plasma Concentration Just Prior to the Next Dose (Cmin)||Up to 72 hours if all 5 doses were administered|The full analysis population for PK (N = 30) was defined as patients who received at least 1 dose of oral study drug and had at least 1 valid quantifiable PK metric||ng/mL||Standard Deviation|Mean
822117|NCT01160614|Primary|Single-dose PK Metric: Area Under the Plasma Concentration-time Curve Extrapolated to Infinity (AUCinf)|Due to insufficient sampling, AUCinf was not estimated.|Up to 24 hours||||||
822118|NCT01160614|Primary|Single-dose PK Metric: Area Under the Plasma Concentration-time Curve From Hour 0 to the Last Measurable Plasma Concentration [AUCt]||Up to 24 hours|The full analysis population for PK (N = 30) was defined as patients who received at least 1 dose of oral study drug and had at least 1 valid quantifiable PK metric||ng*h/mL||Standard Deviation|Mean
822119|NCT01160640|Secondary|Identification of Endometrial Microorganisms Present Obtained From Women With or Without Evidence of Endometritis.|Identification of endometrial microorganisms present obtained from women with or without evidence of endometritis using a combination of culture methods, rRna sequencing and whole genomic sequencing. The aim is to identify the etiology of endometritis.|enrollment|Women who had an endometrial sample that was sufficient for histologic assessment for endometritis.||participants|||Number
822120|NCT01160640|Secondary|Resolution of Clinical Signs and Symptoms of Acute PID - Intention to Treat Analysis|Clinical response to treatment is improvement (reduction) of the McCormack Scale total score from baseline to day 3 follow-up visit. Participants without a 3-day measure were considered treatment failures.|Enrollment to 3 day follow up visit|||participants|||Number
822121|NCT01160640|Secondary|The Eradication of M. Genitalium From the Lower and Upper Genital Tract Following Antibiotic Therapy for Acute PID.|M. genitalium not detected in the cervical and endometrial cultures by nucleic acid amplification testing at the 30 day visit among women who had M. genitalium detected at either anatomical site at the enrollment visit.|Enrollment to 30 days|There were 34 women who had M. genitalium detected in the cervix or endometrium at enrollment who had test results from the 30-day visit.||participants|||Number
822122|NCT01160640|Secondary|The Prevalence of M. Genitalium in the Cervix and Endometrium From Women With Acute PID.|The number of women who had M. genitalium detected in cervical and endometrial biopsy cultures by nucleic acid amplification tests at enrollment.|enrollment|||participants|||Number
822123|NCT01160640|Primary|Clearance of Anaerobic Organisms From the Endometrium|Clearance of anaerobic microorganisms from the endometrium at the 30 day follow-up visit among women who had anaerobic microorganisms detected in their endometrial tissue sample at enrollment. Clearance is defined as no anaerobic microorganisms detected in the endometrial tissue biopsy sample collected at the 30-day visit.|Enrollment to 30 days|Women who had anaerobic microorganisms detected in their endometrial biopsy sample at enrollment based on standard bacterial culture techniques.||participants|||Number
822124|NCT01160744|Other Pre-specified|Change in Tumor Size (CTS)|CTS was defined as the log ratio of tumor size at 6 weeks to tumor size at baseline. CTS at 6 weeks=Log (Sum of Target Lesion Measurements at 6 Weeks)-Log (Sum of Target Lesion Measurements at Baseline).|Baseline, 6 weeks|All randomized participants with results at baseline and 6 weeks.||log ratio||Standard Deviation|Mean
822125|NCT01160744|Other Pre-specified|Percentage of Participants With CR, PR, or Stable Disease (SD) [Disease Control Rate (DCR)]|DCR: percentage of participants with CR, PR, or SD using RECIST v 1.1 criteria. CR: disappearance of all lesions, pathological lymph node reduction in short axis to <10 mm, and normalization of tumor marker levels of non-target lesions. PR: ≥30% decrease in SOD of target lesions taking as reference baseline sum diameter. PD: ≥20% increase in SOD of target lesions and short axes of target lymph nodes, taking as reference smallest sum of longest diameters recorded since treatment started and an absolute increase in sum diameter ≥5 mm; appearance of ≥1 new lesions and/or unequivocal progression of existing non-target lesions. SD: neither sufficient shrinkage to qualify for PR nor increase to qualify for PD. Participants who had no post baseline tumor assessments were considered non-responders and included in the denominator when calculating response rate. Percentage of participants=(number of participants with CR+PR+SD/total number of participants)*100.|Day 1, Cycle 1 (3-week cycles) and every 6 weeks thereafter to PD (up to 24 months)|ITT Population: All randomized participants.||percentage of participants||90% Confidence Interval|Number
822126|NCT01160744|Secondary|Squamous Population OS|OS was defined as the time from the date of randomization to the date of death from any cause. If the participant was alive at the end of the follow-up period or was lost to follow-up, OS was censored on the last date the participant was known to be alive.|Randomization to the date of death from any cause [up to end of study]||06/2018||||
822140|NCT01160822|Secondary|Terminal Phase Half-life (t1/2) of Canakinumab|The time it takes for the concentration level of canakinumab to fall to 50% of the original value.|Day 1, pre-dose and 1, 3, 6 and 8 hours post-dose (Part A only), Day 2, 4, 8, 15, 29, 57, 85 and 126.|Pharmacokinetic analysis set where data were available.||hours||Standard Deviation|Mean
822127|NCT01160744|Secondary|Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Who Died|Data presented are the number of participants with at least 1 treatment-emergent adverse event (TEAE) and treatment-emergent serious adverse event (SAE), as well as, the number of participants who died during the study. TEAEs were defined as serious and other non-serious AEs that occurred or worsened after study treatment (regardless of causality). A summary of SAEs and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.|Day 1, Cycle 1 (3-week cycles) up to 89 weeks of treatment and 1 month post-treatment follow-up|All randomized participants who received at least 1 dose of study drug.||participants|||Number
822128|NCT01160744|Secondary|Duration of Response (DOR)|DOR was measured from the time criteria were met for the first objectively recorded CR or PR until the first date criteria for PD were met or death. Response was defined using RECIST v 1.1 criteria. CR was defined as the disappearance of all lesions, pathological lymph node reduction in short axis to <10 mm, and normalization of tumor marker level of non-target lesions. PR was defined as ≥30% decrease SOD of target lesions taking as reference the baseline sum diameter. PD was defined as ≥20% increase in SOD of target lesions and short axes of target lymph nodes, taking as reference the smallest sum of the longest diameters recorded since treatment started and an absolute increase in sum diameter of ≥5 mm; appearance of ≥1 new lesions and/or unequivocal progression of existing non-target lesions. Participants who did not relapse were censored at the day of their last objective tumor assessment.|Time of first response (CR or PR) until PD or death (up to 24 months)|All randomized participants with a best overall response of CR or PR. Participants censored: Pem+Carb/Cis=44, Ram+Pem+Carb/Cis=35, Gem+Carb/Cis=50, Ram+Gem+Carb/Cis=37.||months||90% Confidence Interval|Median
822129|NCT01160744|Secondary|Overall Survival (OS)|OS was defined as the time from the date of randomization to the date of death from any cause. If the participant was alive at the end of the follow-up period or was lost to follow-up, OS was censored on the last date the participant was known to be alive.|Randomization to the date of death from any cause (up to 31.3 months)|ITT Population: All randomized participants. Participants censored: Pem+Carb/Cis=22, Ram+Pem+Carb/Cis=16, Gem+Carb/Cis=32, Ram+Gem+Carb/Cis=32.||months||90% Confidence Interval|Median
822130|NCT01160744|Secondary|Percentage of Participants With Best Overall Response of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]|Best overall response of CR or PR was defined using RECIST v 1.1 criteria. CR was defined as the disappearance of all lesions, pathological lymph node reduction in short axis to <10 mm, and normalization of tumor marker levels of non-target lesions. PR was defined as ≥30% decrease in SOD of target lesions taking as reference the baseline sum diameter. PD was defined as ≥20% increase in SOD of target lesions and short axes of target lymph nodes, taking as reference the smallest sum of the longest diameters recorded since treatment started and an absolute increase in sum diameter of ≥5 mm; appearance of ≥1 new lesions and/or unequivocal progression of existing non-target lesions. Participants who had no post baseline tumor assessments were considered non-responders and included in the denominator when calculating response rate. Percentage of participants=(number of participants with CR+PR/total number of participants)*100.|Day 1, Cycle 1 (3-week cycles) and every 6 weeks thereafter to PD (up to 24 months)|ITT Population: All randomized participants.||percentage of participants|||Number
822131|NCT01160744|Primary|Progression-Free Survival (PFS)|PFS was the time from randomization to the first objective progression as defined by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v 1.1) or death from any cause, whichever occurred first. Progressive disease (PD) was defined as ≥20% increase in sum of diameter (SOD) of target lesions and short axes of target lymph nodes, taking as reference the smallest sum of the longest diameters recorded since treatment started and an absolute increase in sum diameter of ≥5 millimeters (mm); appearance of ≥1 new lesions and/or unequivocal progression of existing non-target lesions. Participants alive and without disease progression were censored at the time of the last objective tumor assessment. Participants who did not progress and were lost to follow-up were censored at their last radiographic assessment. If no baseline or post baseline radiologic assessments were available, participants were censored at date of randomization.|Randomization to PD or death (up to 24 months)|Intent-to-Treat (ITT) Population: All randomized participants. Participants censored: Pem+Carb/Cis=14, Ram+Pem+Carb/Cis=13, Gem+Carb/Cis=14, Ram+Gem+Carb/Cis=18.||months||90% Confidence Interval|Median
822132|NCT01160770|Secondary|Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms|"The parent/caregiver was asked to rate the patient's overall change in symptoms since the beginning of clobazam treatment by checking very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse."|Baseline to month 36|||percentage of participants|||Number
822133|NCT01160770|Secondary|Investigator Global Evaluations of the Patient's Overall Change in Symptoms|"The physician was asked to rate the patient's overall change in symptoms since the beginning of clobazam treatment by checking very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse."|Baseline to month 36|||percentage of participants|||Number
822134|NCT01160770|Secondary|Percent of Patients Considered Treatment Responders Defined as Those With a ≥25%, ≥50%, ≥75%, 100% Reduction in Drop Seizures Based on the Last 30-day Assessment|Number of drop seizures obtained from seizure diaries|Baseline to month 36|||percentage of participants|||Number
822135|NCT01160770|Secondary|Percent of Patients Considered Treatment Responders Defined as Those With a ≥25%, ≥50%, ≥75%, 100% Reduction in Drop Seizures Based on the 7-day Assessment|Number of drop seizures obtained from seizure diaries|Baseline to month 36|||percentage of participants|||Number
822136|NCT01160770|Primary|Median Percent Reduction in Average Weekly Rate of Drop Seizures Based on the Last 30-day Assessment|Number of drop seizures was obtained from seizure diaries|Baseline to month 36|||percentage of drop seizures||Full Range|Median
822137|NCT01160770|Primary|Median Percent Reduction in Average Weekly Rate of Drop Seizures Based on the 7-day Assessment|Number of drop seizures was obtained from seizure diaries|Baseline to month 36|||percentage of drop seizures||Full Range|Median
822138|NCT01160822|Secondary|Apparent Volume of Distribution During Terminal Phase (Vz/F)||Day 1, pre-dose and 1, 3, 6 and 8 hours post-dose (Part A only), Day 2, 4, 8, 15, 29, 57, 85 and 126.|Pharmacokinetic analysis set, where data were available.||mL||Standard Deviation|Mean
822139|NCT01160822|Secondary|Apparent Clearance of Canakinumab From Plasma (CL/F)||Day 1, pre-dose and 1, 3, 6 and 8 hours post-dose (Part A only), Day 2, 4, 8, 15, 29, 57, 85 and 126.|Pharmacokinetic analysis set, where data were available.||mL/hr||Standard Deviation|Mean
822147|NCT01160822|Secondary|Part B: Physician's Global Assessment of Response to Treatment at Week 4|The study physician made a global assessment of response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor.|Week 4|Pharmacodynamic analysis set, where data were available.||participants|||Number
822148|NCT01160822|Secondary|Part B: Physician's Global Assessment of Response to Treatment at Week 2|The study physician made a global assessment of response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor.|Week 2|Pharmacodynamic analysis set, where data were available.||participants|||Number
822149|NCT01160822|Secondary|Part B: Physician's Global Assessment of Response to Treatment at Day 4|The study physician made a global assessment of response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor.|Day 4|Pharmacodynamic analysis set, where data were available.||participants|||Number
822150|NCT01160822|Secondary|Patient's Global Assessment of Response to Treatment at Week 12|Participants made a global assessment of their response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor.|Week 12|Pharmacodynamic analysis set, where data were available.||participants|||Number
822151|NCT01160822|Secondary|Patient's Global Assessment of Response to Treatment at Week 8|Participants made a global assessment of their response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor.|Week 8|Pharmacodynamic analysis set, where data were available.||participants|||Number
822152|NCT01160822|Secondary|Patient's Global Assessment of Response to Treatment at Week 4|Participants made a global assessment of their response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor.|Week 4|Pharmacodynamic analysis set, where data were available.||participants|||Number
822153|NCT01160822|Secondary|Patient's Global Assessment of Response to Treatment at Week 2|Participants made a global assessment of their response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor.|Week 2|Pharmacodynamic analysis set, where data were available.||participants|||Number
822154|NCT01160822|Secondary|Patient’s Global Assessment of Response to Treatment on Day 4|Participants made a global assessment of their response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor.|Day 4|Pharmacodynamic analysis set, where data were available.||participants|||Number
822155|NCT01160822|Secondary|Part B: Proportion of Participants Who Used Rescue Analgesic During Study|Participants were permitted to take oral rescue medication (Acetaminophen ≤ 4 gram/day) up until 24 hours of a scheduled assessment visit during the 12-week treatment period. The estimates shown are the Kaplan-Meier estimates of the proportion of participants that took rescue medication.|Day 4, Weeks 1, 2, 4, 8 and 12|Safety analysis set (all participants as assigned that received at least one dose of study drug).||proportion of participants|||Number
822156|NCT01160822|Secondary|Part B: Change From Baseline in WOMAC Pain, Stiffness and Physical Function Subscales|"The WOMAC consists of 3 subscales:
The Pain subscale asks patients to rate pain in the index knee joint in the last 48 hours during walking, using stairs, in bed, sitting or lying, and standing on a scale from none (0) to extreme pain (4). The answers are summed and the total pain subscale score ranges from 0-20.
The Stiffness subscale assesses stiffness in the index knee joint during the last 48 hours doing different activities on a scale from none (0) to extreme stiffness (4). The total stiffness subscale score ranges from 0-8.
The Physical Function subscale assesses difficulty performing daily physical activities during the last 48 hours on a scale from none (0) to extreme difficulty (4). The total physical function subscale score ranges from 0-68.
Higher scores indicate more pain/stiffness/difficulty. Results are from a Bayesian ANCOVA model, with baseline WOMAC score as a covariate, time by treatment as fixed effects, region and patient as random effects."|Baseline and Weeks 4, 8 and 12|Pharmacodynamic (PD) analysis set - Patients with any available PD data and no major protocol deviations with impact on PD data.||units on a scale||Standard Deviation|Mean
822157|NCT01160822|Secondary|Part B: Percentage of Responders in the Pain 100 mm Visual Analog Scale (VAS)|A responder is defined as a participant with a 50% or greater reduction from baseline on the VAS scale for pain assessment. After walking for 20 meters, participants were asked to assess the pain in their affected knee on a 100 mm linear visual analog scale ranging from no pain (0 mm) to unbearable pain (100 mm).|Baseline, Day 4, Weeks 1, 2, 4, 8 and 12|Pharmacodynamic (PD) analysis set - Patients with any available PD data and no major protocol deviations with impact on PD data. N is the number of participants with available data at each time point.||percentage of participants|||Number
822158|NCT01160822|Secondary|Part B: Change From Baseline in Pain Using 100 mm Visual Analog Scale (VAS)|"After walking for 20 meters, participants were asked to assess the pain in their affected knee on a 100 mm linear visual analog scale ranging from no pain (0 mm) to unbearable pain (100 mm).
Results are from a Bayesian ANCOVA model, fitting baseline pain VAS score as a covariate, time by treatment as fixed effects, region and patient as random effects."|Baseline and Weeks 4, 8 and 12|Pharmacodynamic (PD) analysis set - Patients with any available PD data and no major protocol deviations with impact on PD data.||units on a scale||Standard Deviation|Mean
822159|NCT01160822|Primary|Part B: Change From Baseline to Week 4 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale|"The Western Ontario and McMaster osteoarthritis Index (WOMAC) pain subscale asks patients to rate pain in the index knee joint in the last 48 hours doing different activities on a scale from none (0) to extreme pain (4). The answers are summed and the total pain subscale score ranges from 0 to 20, where higher scores indicate more pain. A negative change from Baseline score indicates improvement.
Results are from a Bayesian ANCOVA model, fitting baseline WOMAC pain score as a covariate, time by treatment as fixed effects, region and patient as random effects."|Baseline and Week 4|Pharmacodynamic (PD) analysis set - Patients with any available PD data and no major protocol deviations with impact on PD data, and where data were available.||units on a scale||Standard Deviation|Mean
822160|NCT01160822|Primary|Part B: Change From Baseline to Day 4 in Pain Using 100 mm Visual Analog Scale (VAS)|"After walking for 20 meters, participants were asked to assess the pain in their affected knee on a 100 mm linear visual analog scale ranging from no pain (0 mm) to unbearable pain (100 mm). A negative change from Baseline score indicates improvement.
Results are from a Bayesian analysis of covariance (ANCOVA) model, fitting baseline pain VAS score as a covariate, time by treatment as fixed effects, region and subject as random effects."|Baseline and Day 4|Pharmacodynamic (PD) analysis set - Patients with any available PD data and no major protocol deviations with impact on PD data, and where data were available.||units on a scale||Standard Deviation|Mean
822161|NCT01160822|Primary|Part A: Number of Participants With Intolerance Events|An intolerance event is defined as an acute inflammatory reaction, characterized by a 30 mm increase in pain (on a 100 mm visual analog scale (VAS) and associated with a new or worsened synovial fluid effusion within 3 days following the intra-articular (i.a.) injection. If baseline VAS pain score is ≥ 70 mm, an intolerance event is defined as an increase in pain by 20 mm on a 100 mm VAS associated with new or worsened synovial fluid effusion within 3 days following the i.a. injection. If baseline VAS pain score is ≥ 80 mm, an intolerance event is defined as an increase in pain by 10 mm on a 100 mm VAS associated with new or worsened synovial fluid effusion within 3 days following the i.a. injection. If baseline pain score is ≥ 90 mm, an intolerance event is defined as the patients experiencing an unspecified increase in pain on a 100 mm VAS associated with new or worsened synovial fluid effusion within 3 days following the i.a. injection.|Baseline to Day 3|Safety analysis set.||participants|||Number
822162|NCT01160848|Primary|Photoactive Porphyrins Level|Photoactive porphyrins levels on the skin surface of acne patients, part 2, measured by in vivo fluorescence spectroscopy|24 hours after cream application|||Fluorescence intensity unit||95% Confidence Interval|Mean
822163|NCT01160848|Primary|Photoactive Porphyrins Level|Photoactive porphyrins levels on the skin surface of acne patients, part 2, measured by in vivo fluorescence spectroscopy|12 hours after cream application|||Fluorescence intensity unit||95% Confidence Interval|Mean
822164|NCT01160848|Primary|Photoactive Porphyrins Level|Photoactive porphyrins levels on the skin surface of acne patients, part 2, measured by in vivo fluorescence spectroscopy|8 hours after cream application|||Fluorescence intensity unit||95% Confidence Interval|Mean
822165|NCT01160848|Primary|Photoactive Porphyrins Level|Photoactive porphyrins levels on the skin surface of acne patients, part 2, measured by in vivo fluorescence spectroscopy|3 hours after cream application|||Fluorescence intensity unit||95% Confidence Interval|Mean
822166|NCT01160848|Primary|Photoactive Porphyrins Level|Photoactive porphyrins levels on the skin surface of acne patients, part 1, measured by in vivo fluorescence spectroscopy|3 hours after cream application|||Fluorescence intensity unit||95% Confidence Interval|Mean
822167|NCT01160848|Primary|Photoactive Porphyrins Level|Photoactive porphyrins levels on the skin surface of acne patients, part 1, measured by in vivo fluorescence spectroscopy|1.5 hours after cream application|||Fluorescence intensity unit||95% Confidence Interval|Mean
822168|NCT01161121|Secondary|Side Effects of Medication Administration|Chest pain, chest discomfort, burning, flushing, headache, nausea, or shortness of breath|During drug infusion and until restoration of baseline hemodynamics|||participants|||Number
822169|NCT01161121|Secondary|Heart Rate Changes With Drug|Maximal heart rate documented following the administration of each agent|During drug infusion and until restoration of baseline hemodynamics|||beats per minute||Standard Deviation|Mean
822170|NCT01161121|Primary|Difference in FFR Between IV Adenosine and IV Regadenoson|FFR (as calculated by the ratio of lowest Pd/Pa at maximal hyperemia) was compared between hyperemia achieved with adenosine and with regadenoson|At maximal, steady-state hyperemia|Per protocol||ratio (Pd/Pa)||Standard Deviation|Mean
822171|NCT01161160|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the entire study period (Day 0 to Day 182)|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received the study vaccine.||Participants|||Count of Participants
822172|NCT01161160|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Up to 21 days after vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received the study vaccine.||Participants|||Count of Participants
822173|NCT01161160|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within the 42-day (Days 0-41) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received the study vaccine.||Participants|||Count of Participants
822174|NCT01161160|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within the 21-day (Days 0-20) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received the study vaccine.||Participants|||Count of Participants
822175|NCT01161160|Secondary|Number of Subjects With pIMDs|Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|During the entire study period (Day 0 to Day 182)|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received the study vaccine.||Participants|||Count of Participants
822176|NCT01161160|Secondary|Number of Subjects With Potential Immune-mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|Up to Day 21|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received the study vaccine.||Participants|||Count of Participants
830144|NCT01227629|Secondary|Thromboembolic Events: Number of Participants Who Died|Occurence of death by all causes|12 weeks|All randomized patients. No statistical comparisons were performed, due to the extremely small number of events.||Participants|||Number
822177|NCT01161160|Secondary|Number of Subjects With MAEs|MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. Analysis of intensity and relationship to vaccination of MAEs was not performed.|During the entire study period (Day 0 to Day 182)|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received the study vaccine.||Participants|||Count of Participants
822178|NCT01161160|Secondary|Number of Subjects With Medically-attended Adverse Events (MAEs)|MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. Analysis of intensity and relationship to vaccination of MAEs was not performed.|Up to day 21|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received the study vaccine.||Participants|||Count of Participants
822179|NCT01161160|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches, shivering, sweating and fever [defined as axillary temperature equal to or above 38.0 degrees Celsius (°C)]. Any = occurrence of any general symptom regardless of intensity grade or relation to vaccination. Grade 3 symptom= symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C, but ≤ 40.0 °C. Related= general symptom assessed by the investigator as causally related to the vaccination. This outcome measure refers to subjects aged 6 to 10 years.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all subjects aged 6 to 10 years who received the study vaccine.||Participants|||Count of Participants
822180|NCT01161160|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above 38.0 degrees Celsius (°C)]. Any = occurrence of any general symptom regardless of intensity grade or relation to vaccination. Grade 3 drowsiness= drowsiness that prevented normal activity. Grade 3 irritability= crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite= not eating at all. Grade 3 fever = fever > 39.0 °C or > 40.0 °C. Related= general symptom assessed by the investigator as causally related to the vaccination. This outcome measure refers to subjects aged 3 to 5 years.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all subjects aged 3 to 5 years who received the study vaccine.||Participants|||Count of Participants
822181|NCT01161160|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain for children less than 6 years= cried when limb was moved/spontaneously painful. Grade 3 pain for children aged 6 to < 10 years= pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received the study vaccine.||Participants|||Count of Participants
822182|NCT01161160|Secondary|HI Antibody Titers Against Flu A/CAL/7/09 H1N1 Strain|Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value of ≥ 1:10. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance.|At Day 182|The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 182 days after vaccination were available.||Titers||95% Confidence Interval|Geometric Mean
822183|NCT01161160|Secondary|Number of Subjects With HI Antibody Titers Against Flu A/CAL/7/09 H1N1 Above the Cut-off Value|The cut-off value for the humoral immune response in terms of vaccine H1N1 HI antibodies were equal to or above (≥) 1:10. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance.|At Day 182|The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 182 days after vaccination were available.||Participants|||Count of Participants
822184|NCT01161160|Secondary|HI Antibody Titers Against Flu A/CAL/7/09 H1N1 Strain|Titers are presented as geometric mean titers (GMTs), for the seropositivity cut-off value of ≥ 1:10. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance.|At Day 21|The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after vaccination were available.||Titers||95% Confidence Interval|Geometric Mean
822185|NCT01161160|Secondary|Number of Subjects With HI Antibody Titers Against Flu A/CAL/7/09 H1N1 Above the Cut-off Value|The cut-off value for the humoral immune response in terms of vaccine H1N1 HI antibodies were egual to or above (≥) 1:10. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance.|At Day 21|The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after vaccination were available.||Participants|||Count of Participants
822186|NCT01161160|Secondary|Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain|GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance. The CHMP criterion was fulfilled if the post-vaccination point estimate for SCF was > 2.5.|At Day 182|The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 182 days after vaccination were available.||Fold increase||95% Confidence Interval|Geometric Mean
822195|NCT01161173|Secondary|Overall Survival|Overall survival was defined as the time from Baseline until or death from any cause|Baseline to the end of the study (up to 4 years, 4 months)|Per-protocol population: All enrolled participants who started erlotinib therapy and did not violate the study protocol.||Months||95% Confidence Interval|Median
822187|NCT01161160|Secondary|Number of Seroprotected Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance. The CBER criterion was fulfilled if the lower limit of the 95% CI for seroprotection (SPR) was > 70%. The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was > 70%.|At Day 0 and Day 182|The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 182 days after vaccination were available.||Participants|||Count of Participants
822188|NCT01161160|Secondary|Number of Seroconverted Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain|Seroconversion rate (SCR) was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer ≥ 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance. The CBER criterion was fulfilled if the lower limit of the 95% CI for SCR was > 40%. The CHMP criterion was fulfilled if the post-vaccination point estimate for SCR was > 40%.|At Day 182|The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 182 days after vaccination were available.||Participants|||Count of Participants
822189|NCT01161160|Primary|Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain|GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance. The CHMP criterion was fulfilled if the point estimate for GMFR was > 2.5.|At Day 21|The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after vaccination were available.||Fold increase||95% Confidence Interval|Geometric Mean
822190|NCT01161160|Primary|Number of Seroprotected Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance. The CBER criterion was fulfilled if the lower limit of the 95% CI for seroprotection (SPR) was > 70%. The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was > 70%.|At Day 21|The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjeects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after vaccination were available.||Participants|||Count of Participants
822191|NCT01161160|Primary|Number of Seroprotected Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance. The CBER criterion was fulfilled if the lower limit of the 95% CI for seroprotection (SPR) was > 70%. The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was > 70%.|At Day 0|The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after vaccination were available.||Participants|||Count of Participants
822192|NCT01161160|Primary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 H1N1 Strain|Seroconversion rate (SCR) was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titer below (<) 10 and a post-vaccination reciprocal titre greater than or equal to (≥) 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus. The Flu strain assessed was A/California/7/2009 (H1N1)v-like virus (Flu A/CAL/7/09), following the Committee for Medicinal Products for Human Use (CHMP) and the Center for Biologics Evaluation and Research (CBER) guidance. The CBER criterion was fulfilled if the lower 95% confidence interval (CI) for SCR was (>) 40%. The CHMP criterion was fulfilled if the point estimate for SCR was > 40%.|At Day 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after vaccination were available.||Participants|||Count of Participants
822193|NCT01161173|Secondary|Percentage of Participants Who Developed Rash|At each study visit, the presence of skin rash was graded using the Common Toxicity Criteria (CTC), with grade 0 = no rash, grade 1 = mild, grade 2 = moderate, grade 3 = severe, and grade 4 = life threatening or disabling rash. Reported is the percentage of participants who developed a grade ≥ 1 rash.|Baseline to the end of the study (up to 4 years, 4 months)|Per-protocol population: All enrolled participants who started erlotinib therapy and did not violate the study protocol.||Percentage of participants||95% Confidence Interval|Number
822194|NCT01161173|Secondary|Change From Baseline in the Lung Cancer Symptom Scale (LCSS) Scores|Study participants and treating physicians completed the LCSS, a measure of Quality of Life (QoL), at Baseline and throughout the study. The patient LCSS measures 6 major symptoms, the Symptom Burden Index (SBI), associated with lung malignancies (3 thoracic [cough, dyspnea, haemoptysis] and 3 general symptoms [loss of appetite, fatigue, pain]) and 3 additional scores (overall symptomatic distress, interference with daily activities, global QoL), each on a 100 mm visual analogue scale (0=no impairment, 100=maximum impairment). The physician LCSS evaluates the 6 lung malignancy associated symptoms, the SBI, on an ordinal scale (100=none, 75=mild, 50=moderate, 25=marked, 0=severe). The average of the patient and physician SBI scores (6 symptoms) and the average of the patient total score (9 symptoms) ranged from 0 to 100, with a higher patient and a lower physician score indicating more impairment. A negative patient and a positive physician change score indicates improvement.|Baseline to the end of the study (up to 4 years, 4 months)|Per-protocol population: All enrolled participants who started erlotinib therapy and did not violate the study protocol. Only participants with LCSS scores were included in the analysis.||Units on a scale||95% Confidence Interval|Mean
822196|NCT01161173|Secondary|Progression-free Survival|Progression-free survival was defined as the time from Baseline until disease progression or death from any cause. Progressive disease was determined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.|Baseline to the end of the study (up to 4 years, 4 months)|Per-protocol population: All enrolled participants who started erlotinib therapy and did not violate the study protocol. Only participants with an evaluable response were included in the analysis.||Months||95% Confidence Interval|Median
822197|NCT01161173|Secondary|Time to Disease Progression|The time to disease progression was defined as the time from Baseline until disease progression as determined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.|Baseline to the end of the study (up to 4 years, 4 months)|Per-protocol population: All enrolled participants who started erlotinib therapy and did not violate the study protocol. Only participants with an evaluable response were included in the analysis.||Months||95% Confidence Interval|Median
822198|NCT01161173|Primary|Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)|The best overall response to treatment was determined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. A CR was defined as the disappearance of all target lesions (TL) or the disappearance of all non-TLs. A PR was defined as at least a 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD. SD was defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since treatment started for TLs and the persistence of 1 or more non-TL(s). PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. For the best overall responses of CR and PR, a response was “confirmed” if a subsequent RECIST evaluation also showed a CR or PR.|Baseline to the end of the study (up to 4 years, 4 months)|Per-protocol population: All enrolled participants who started erlotinib therapy and did not violate the study protocol. Only participants with an evaluable response were included in the analysis.||Percentage of participants||95% Confidence Interval|Number
822199|NCT01161225|Secondary|Health Care Utilization Events|Participants report the following information for the prior 3-month period; their emergency department visits for asthma; hospitalization for asthma; urgent office visit for worsening asthma; routine office visit; specialist visit. A cumulative number of events were computed by adding # of visits and # of days (for hospitalization) occurred in the past 3 months .|9-months postcamp|the number of participants analyzed includes only those who stayed in the study and completed the 9-months assessment.||average number of events||Standard Deviation|Mean
822200|NCT01161225|Secondary|Forced Expiratory Volume in 1 Second (FEV1) % Predicted|Maximal amount of air one can forcefully exhale in one second. It is then converted to a percentage of normal. Range: 55-124 for the current sample.|9 months post camp|the number of participants analyzed includes only those who stayed in the study and completed spirometry at 9-months assessment.||percentage of predicted FEV1||Standard Deviation|Mean
822201|NCT01161225|Secondary|Asthma Knowledge Questionnaire|This 30-item instrument was developed to measure children’s knowledge on triggers and symptom identifications, and asthma management procedures (i.e., what to do and how to do it) in a true/false format. Total scores (range: 14-30) were computed by summing the number of items correctly answered. The higher scores indicate greater knowledge levels.|9 months post camp|the number of participants analyzed includes only those who stayed in the study and completed the 9-months assessment.||units on a scale||Standard Deviation|Mean
822202|NCT01161225|Secondary|Attitude Toward Illness Scale|This 13-item scale was designed to assess children’s attitude toward their health condition. The scale includes questions such as “how good or bad do you feel it is that you have ___?” and, “how often do you feel that your ___ is your fault?” Respondents answer each question on a 5-point Likert-type scale (1-5). Total summed scores (range: 25-65) was constructed to reflect respondents’ overall attitudes. Higher scores indicated positive attitudes.|9 months post camp|the number of participants analyzed includes only those who stayed in the study and completed the 9-months assessment.||units on a scale||Standard Deviation|Mean
822203|NCT01161225|Secondary|Illness Management Survey|This 29-item scale was developed to assess perception of barriers and to predict risk for poor self-management in adolescents with chronic illness. This scale categorizes barriers based on internal processes (e.g., cognitive skills, denial, pessimistic thinking) and contextual forces (e.g., illness-related factors, peer/family influences). Total summed scores were computed (range: 28-91). Higher scores indicate the high levels of perceived barriers to self-management.|9 months post camp|the number of participants analyzed includes only those who stayed in the study and completed the 9-months assessment.||units on a scale||Standard Deviation|Mean
822204|NCT01161225|Secondary|Asthma Self-Efficacy|This 14-item scale was developed to measure the child’s confidence in attack prevention (e.g., learn asthma self-management skills, correct use of medication) and attack management (e.g., control symptoms, decide which medication to use). Total summed scores were computed (range: 21-70). Higher total scores indicate greater degree of self-efficacy.|9 months post camp|the number of participants analyzed includes only those who stayed in the study and completed the 9-months assessment.||units on a scale||Standard Deviation|Mean
822205|NCT01161225|Primary|Asthma Control Questions|This measure assesses the frequencies of the limitation of daily activity, asthma symptoms (daytime and nighttime) and use of rescue medication in the past 4 weeks on a 5-point scale (0-4). Total summed scores were computed (range: 4-16). Higher total scores indicate better controlled asthma.|9 months post camp|the number of participants analyzed includes only those who stayed in the study and completed the 9-months assessment.||units on a scale||Standard Deviation|Mean
822220|NCT01161446|Secondary|Number of Male Condomless Anal Intercourse Partners in Last 3 Months||From 6 to 9 and 12 to 15 months|"Included Overall Number of Participants Analyzed as number who completed follow-up. However, only participants who responded to the question regarding condomless anal intercourse partners in the last 3 months were included in this analysis for each time point."||number of partners||Standard Error|Mean
822206|NCT01161225|Primary|Pediatric Asthma Quality of Life Questionnaire (PAQLQ)|Twenty-three items cover problems identified as being most important and troublesome in children’s everyday lives due to asthma. This scale is effective in evaluating and discriminating because of its high sensitivity to changes in asthma status within and between individuals with varying severity of asthma. Respondents are asked to recall impairments experienced during the previous week. The scale consists of three subdomains including symptoms (10 items), emotional function (8 items) and activity limitation (5 items). Each item was measured on a 7-point scale; 1 indicates maximum impairment, and 7 indicates no impairment. Higher total scores indicate better levels of functioning. Total scores were computed by summing responses from all items (range:24-161)|9 months post camp|The number of participants analyzed includes only those who stayed in the study and completed the 9-months assessment.||units on a scale||Standard Deviation|Mean
822207|NCT01161329|Primary|Short Physical Performance Battery (SPPB)|Total score on the scale: 0-12 Points. Higher scores indicates better functioning. SPPB evaluates balance, gait, strength and endurance by examining an individual's ability to stand with feet together in side-by-side, semi-tandem and tandem positions, time to walk 8 ft and time to rise from a chair and return to the seated position five times.|Baseline, after 3, 6 months and after 1 year|||units on a scale||Standard Deviation|Mean
822208|NCT01161329|Primary|The Berg Balance Scale (BBS)|Total score on the scale: 0-56 Points. Higher scores indicates better balance.|baseline, after 3, 6 months and after 1 year|||units on a scale||Standard Deviation|Mean
822209|NCT01161407|Secondary|"Bone Balance From Calcium Kinetics"|Calcium kinetics was determined by a calcium radiotracer. Bone balance is the difference between bone formation and bone resorption estimated by calcium kinetic modeling.|2 weeks|||mg/d calcium||Standard Error|Least Squares Mean
822210|NCT01161407|Secondary|Phosphorus Balance|Phosphorus balance is measured by dietary phosphorus intake (mg/d) minus phosphorus excretion (mg/d) from both urine and feces.|2 weeks|||mg/d phosphorus||Standard Error|Least Squares Mean
822211|NCT01161407|Primary|Calcium Balance|Calcium balance is measured by dietary calcium intake (mg/d) minus calcium excretion (mg/d) (from both urine and feces).|2 weeks|||mg/d calcium||Standard Error|Least Squares Mean
822212|NCT01161420|Secondary|Percentage Sleep Time at SaO2 < 90%|"The percentage of time spent with oxygen saturation below 90% has been an increasingly utilized surrogate for morbidity risk in sleep apnea populations.
The SaO2 secondary endpoint in this study was determined by the time below an SaO2 level of 90% during the 12-month PSG study compared to that at baseline (average of screening and 1-month PSG studies). The objective was to demonstrate a decrease in the percentage of sleep time with an SaO2 level below 90% at 12 months."|12 months|||Percentage of Sleep Time SaO2 <90%||95% Confidence Interval|Mean
822213|NCT01161420|Secondary|Change Epworth Sleepiness Scale (ESS) From Baseline to 12 Months|The Epworth Sleepiness Scale (ESS) is a validated instrument that rates a subject’s daytime sleepiness. Like the FOSQ, it is a quality of life measure that is commonly used in clinical evaluation and management of OSA. Scores range from 0 to 24, with lower scores indicating greater functioning. An ESS score of less than 10 is considered to be the cutpoint for normal subjective sleepiness.|Baseline and 12 months|||units on a scale||95% Confidence Interval|Mean
822214|NCT01161420|Secondary|Change in FOSQ From Baseline to 12 Months|The Functional Outcomes Sleep Questionnaire (FOSQ) is a validated instrument that assesses the effect of a subject’s daytime sleepiness on activities of ordinary living. It is a quality of life measure that is commonly used in the clinical evaluation and management of OSA. This self-administered instrument consists of 30 questions divided into 5 domains: activity level, vigilance, intimacy, general productivity and social outcome. Scores range from 5 to 20, with higher scores indicating greater functioning. Change in FOSQ was calculated by subtracting the baseline score from the 12-month score.|Baseline and 12 months|||units on a scale||95% Confidence Interval|Mean
822215|NCT01161420|Secondary|Modified Intent to Treat - AHI Responder Rate for All Implanted Subjects|"The intent-to-treat (ITT) analysis for the primary endpoint included all patients who underwent an implant. A modified ITT analysis was conducted to include the subjects who did not completed the 12-month follow-up sleep study also. The ITT analysis was to calculate the AHI responder rate based on the subjects included in the analysis as described below. An Inspire therapy AHI responder was defined as a subject who experienced at least a 50% reduction in AHI from baseline and had an AHI of less than 20 at their last visit.
The following subjects were included:
All implanted subjects who had AHI data collected at both baseline and 12-months follow-up.
All implanted subjects who had baseline data but no 12-month data, and had their last data values carried forward, provide they had a least 6-month AHI data.
Any implanted subject who did not have 12-month data available due to therapy failure (e.g., study withdrawal will be included in the analsys as a treatment failure."|12 months|Implanted subjects||Number of subjects responding to therapy|||Number
822216|NCT01161420|Secondary|AHI for the Randomized Controlled Therapy (RCT) Withdrawal Study|The AHI difference between the 12-month PSG study and the 13-Month PSG study in the therapy maintenance group will be compared to the AHI difference in the therapy withdrawal group. The objective was to demonstrate that AHI increase in the therapy withdrawal group (therapy=OFF) is greater than any AHI change in the active therapy group (therapy=ON). AHI is the number of apneas or hypopneas recorded during a sleep study per hour of sleep; this is calculated by dividing the number of AHI events by the number of hours of sleep.|12 Months|The first 46 responders to the Inspire therapy at 12 months were randomized 1:1 to either the Therapy Maintenance Group (ON) or the Therapy Withdrawal Group (OFF). A subsequent sleep study of the two randomized groups was conducted and results were compared between the two groups.||events per hour||95% Confidence Interval|Mean
822217|NCT01161420|Primary|Safety|The primary safety objective of this pivotal trial was to evaluate safety via a description of all reported adverse events. Per the IDE-approved protocol, no formal statistical hypothesis was tested as part of the safety assessment.|12 months|||Events Reported|||Number
822218|NCT01161420|Primary|Oxygen Desaturation Index|Demonstrate at least a 50% responder rate at the 12-month follow-up visit. An Inspire therapy ODI responder was defines as a subject who experienced at least a 25% reduction in ODI from baseline.|12 months|||percentage of subjects responding|||Number
822219|NCT01161420|Primary|Apnea Hypopnea Index|Demonstrate at least a 50% responder rate at the 12-month follow-up visit. An Inspire therapy AHI responder was defined as a subject who experienced at least a 50% reduction in AHI from baseline and had an AHI of less than 20 at the 12-month follow-up.|12 months|||percentage of subjects responding|||Number
822222|NCT01161446|Secondary|Condomless Anal Intercourse With HIV-positive or Unknown Status Partner in Last 3 Months||From 6 to 9 months and 12 to 15 months of follow-up|"Included Overall Number of Participants Analyzed as number who completed follow-up. However, only participants who responded to the question regarding non-concordant condomless anal intercourse in the last 3 months were included in this analysis for each time point."||Participants|||Count of Participants
822223|NCT01161446|Primary|HIV Testing Frequency|Number of HIV tests during follow-up reported by participants at end-of-study visit|15 months|||HIV tests||95% Confidence Interval|Mean
822224|NCT01161472|Secondary|Rey Auditory Verbal Learning Test (RAVLT) on Day 6|RAVLT evaluates a wide diversity of functions: short-term auditory-verbal memory, rate of learning, learning strategies, retroactive, and proactive interference, presence of confabulation of confusion in memory processes, retention of information, and differences between learning and retrieval. Assessment of RAVLT is between 10 to 15 minutes; Performance variable: the sum of the number of words recalled successfully on the delayed recall trial. Higher score meant a better performance.|Baseline and Day 6|The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.||Words Recalled||Standard Error|Least Squares Mean
822225|NCT01161472|Secondary|Rey Auditory Verbal Learning Test (RAVLT)|RAVLT evaluates a wide diversity of functions: short-term auditory-verbal memory, rate of learning, learning strategies, retroactive, and proactive interference, presence of confabulation of confusion in memory processes, retention of information, and differences between learning and retrieval. Assessment of RAVLT is between 10 to 15 minutes; Performance variable: the sum of the number of words recalled successfully on the delayed recall trial. Higher score meant a better performance.|Baseline|The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.||Words Recalled||Standard Deviation|Mean
822226|NCT01161472|Secondary|Change From Baseline in CogState Groton Maze Learning Task on Day 6|GMLT: a cognitive test which assessed executive function. Participant was shown a 10 x 10 grid of tiles on a computer touch screen. A 28-step pathway was hidden among 100 possible locations. The participant was instructed to move 1 step from the start location and then continue 1 tile at a time, toward the end to find the pathway. The outcome measure was total number of errors made in attempting to learn the same hidden pathway on 5 consecutive trials at a single session. Lower scores meant a better performance.|Baseline and Day 6|The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.||Errors||Standard Error|Least Squares Mean
822227|NCT01161472|Secondary|CogState Groton Maze Learning Task (GMLT)|GMLT: a cognitive test which assessed executive function. Participant was shown a 10 x 10 grid of tiles on a computer touch screen. A 28-step pathway was hidden among 100 possible locations. The participant was instructed to move 1 step from the start location and then continue 1 tile at a time, toward the end to find the pathway. The outcome measure was total number of errors made in attempting to learn the same hidden pathway on 5 consecutive trials at a single session. Lower scores meant a better performance.|Baseline|The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.||Errors||Standard Deviation|Mean
822228|NCT01161472|Secondary|Change From Baseline in CogState CPAL on Day 6|CPAL: a cognitive test which assessed visual episodic learning. Participant was to learn and remember picture locations on the screen and was to tap the target on the central location to begin. As each picture was revealed, the participant was to remember where the picture was located and tap that location. The outcome measure was the number of errors made in correctly placing each of the 4 patterns in their location 4 times. Lower scores meant a better performance.|Baseline and Day 6|The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.||Errors||Standard Error|Least Squares Mean
822229|NCT01161472|Secondary|CogState Continuous Paired Associate Learning (CPAL)|CPAL: a cognitive test which assessed visual episodic learning. Participant was to learn and remember picture locations on the screen and was to tap the target on the central location to begin. As each picture was revealed, the participant was to remember where the picture was located and tap that location. The outcome measure was the number of errors made in correctly placing each of the 4 patterns in their location 4 times. Lower scores meant a better performance.|Baseline|The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.||Errors||Standard Deviation|Mean
822230|NCT01161472|Secondary|Change From Baseline in CogState One Card Learning on Day 6|One card learning: a cognitive test which assessed visual learning. Participants were to remember which cards were previously shown in a task. The outcome measure was accuracy of performance; arcsine transformation of the square root (sqrt) of the proportion of correct responses. Higher scores meant a better performance.|Baseline and Day 6|The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.||Arcsine [(sqrt) proportion correct]||Standard Error|Least Squares Mean
822281|NCT01162122|Secondary|Persistence of GMTs Against Homologous and Heterologous Strains|The GMTs against homologous and heterologous strains, persisting in subjects at six months (day 181) and one year (day 366) after vaccination with either aTIV or TIV.|Day 181, Day 366 post vaccination|The analysis was done on the FAS (persistence) subset population i.e all randomized population only from US sites who received a study vaccination, provided evaluable blood samples at day 1, day 22, day 181, and day 366.||Titers||95% Confidence Interval|Geometric Mean
822231|NCT01161472|Secondary|CogState One Card Learning|One card learning: a cognitive test which assessed visual learning. Participants were to remember which cards were previously shown in a task. The outcome measure was accuracy of performance; arcsine transformation of the square root (sqrt) of the proportion of correct responses. Higher scores meant a better performance.|Baseline|The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.||Arcsine [(sqrt) proportion correct]||Standard Deviation|Mean
822232|NCT01161472|Secondary|Change From Baseline in CogState Identification Speed on Day 6|Identification speed: a cognitive test which assessed visual attention. A playing card was presented face up in the center of the screen. As soon as this happened, the participant had to decide whether the card was red or not. The outcome measure was speed of performance; mean of the log10 transformed reaction time for correct responses (measured in log10 MS). Lower scores meant a better performance.|Baseline and Day 6|The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.||Log10 MS||Standard Error|Least Squares Mean
822233|NCT01161472|Secondary|CogState Identification Speed|Identification speed: a cognitive test which assessed visual attention. A playing card was presented face up in the center of the screen. As soon as this happened, the participant had to decide whether the card was red or not. The outcome measure was speed of performance; mean of the log10 transformed reaction time for correct responses (measured in log10 MS). Lower scores meant a better performance.|Baseline|The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.||Log10 MS||Standard Deviation|Mean
822234|NCT01161472|Primary|Change From Baseline in Computer Based Objective Cognition Testing (CogState) Detection Speed on Day 6|Detection speed: a cognitive test which assessed psychomotor function. A playing card was presented face up in the center of the screen. As soon as this happened, the participant was to press the 'Yes' key. The outcome measure was speed of performance; mean of the log10 transformed reaction time for correct responses [measured in log10 milliseconds (MS)]. Lower scores meant a better performance.|Baseline and Day 6|The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.||Log10 MS||Standard Error|Least Squares Mean
822235|NCT01161472|Primary|Computer Based Objective Cognition Testing (CogState) Detection Speed|Detection speed: a cognitive test which assessed psychomotor function. A playing card was presented face up in the center of the screen. As soon as this happened, the participant was to press the 'Yes' key. The outcome measure was speed of performance; mean of the log10 transformed reaction time for correct responses [measured in log10 milliseconds (MS)]. Lower scores meant a better performance.|Baseline|The Per Protocol (PP) Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.||Log10 MS||Standard Deviation|Mean
822236|NCT01161498|Secondary|Participants With N1-2 Disease at Baseline Requiring Neck Dissection|Participants with Baseline Nl or N2 disease (lymph node metastasis not more than 6 cm in greatest dimension) with persistent disease as determined at the post chemoradiotherapy assessment of response were to proceed to neck dissection as permitted by the institution no later than Week 22. Since this study terminated prematurely neck dissection data were not collected or analyzed.|Weeks 19 - 21||||||
822237|NCT01161498|Secondary|Disease-specific Survival|"Disease-specific survival is defined as the time from randomization to death of the patient due to the cancer under study.
Because this study was terminated with 5 participants enrolled, disease-specific survival was not analyzed."|Up to 5 years after chemoradiotherapy||||||
822238|NCT01161498|Secondary|Overall Survival|"Overall survival is defined as the time from randomization to death from any cause.
Because this study was terminated with 5 participants enrolled, overall survival was not analyzed."|Up to 5 years after chemoradiotherapy||||||
822239|NCT01161498|Secondary|Time to Any Failure|"Any failure is defined as disease progression at any site at any time following completion of chemoradiotherapy.
Because this study was terminated with 5 participants enrolled, time to any failure was not analyzed."|Up to 27 months||||||
822240|NCT01161498|Secondary|Time to Distant Failure|"Distant failure is defined as disease progression at any site other than the head and neck area at any time following completion of chemoradiotherapy.
Because this study was terminated with 5 participants enrolled, time to distant failure was not analyzed."|Up to 27 months||||||
822241|NCT01161498|Secondary|Time to Locoregional Failure|"Locoregional failure is defined as disease progression in the head and neck area at any time following completion of chemoradiotherapy.
Because this study was terminated with 5 subjects enrolled, time to locoregional failure was not analyzed."|Up to 27 months||||||
822242|NCT01161498|Secondary|Pathologic Complete Response (mCR)|"Response to therapy was assessed histopathologically from biopsies taken at surgery for those participants who had surgery prior to Week 22.
If no viable tumor cells were identified in surgical specimens (where the patient had surgery) the patient was classified as having a pathological complete response (pCR), and if viable tumor cells were identified, the patient was classified as having an incomplete pathologic response.
Because this study was terminated with 5 patients enrolled, data for this endpoint were summarized in by-patient listings only and the pathologic complete response rate was not calculated. Therefore a summary of participants with a pathologic complete response before the end of study is reported."|Up to Week 20|Randomized participants who had protocol-specified surgery||participants|||Number
822295|NCT01162122|Primary|Percentage of Subjects With HI Titers ≥40 Against Homologous Strains|The percentage of subjects demonstrating HI titers ≥40, in overall group and in subjects with pre-defined co-morbidities (high risk group), against homologous strains, three weeks after vaccination with aTIV or TIV.|Day 22 post vaccination|Analysis was done on the FAS.||Percentage of subjects||95% Confidence Interval|Number
822243|NCT01161498|Secondary|Metabolic Complete Response (mCR)|"Response to therapy was assessed using [(18)F] fluorodeoxyglucose positron emission tomography (FDG PET) imaging to detect metabolically active tumors.
Metabolic complete response (mCR) is defined as complete disappearance of FDG uptake attributable to tumor compared to baseline scan.
Partial metabolic response (mPR) is defined as a > 40% decrease in specific uptake compared to the initial value in over half of the lesions.
Disease progression (mPD) is defined as a specific uptake increase in any lesion, appearance of new lesions, or presence of extended areas of disease activity.
Stable metabolic response (mSD) is defined as a decrease in uptake < 40% of the initial value of over half the lesions.
Because this study was terminated with 5 patients enrolled, data for this endpoint were summarized in by-patient listings only and the metabolic complete response rate was not calculated. Therefore a summary of metabolic response at end of study is reported."|End of study; the maximum time on study was 20 weeks.|All randomized participants||participants|||Number
822244|NCT01161498|Secondary|Clinical Objective Response (cOR)|"Tumor response was assessed by computed tomography (CT) scan according to a modified version of the revised Response Evaluation Criteria In Solid Tumors (RECIST) criteria (version 1.1). Objective response is defined as achieving a clinical partial response (cPR) or complete response (cCR). cCR is defined as disappearance of all baseline lesions. Any pathological lymph nodes must have a reduction in short axis to < 10 mm. cPR is defined as at least a 30% decrease in the sum of diameters of baseline lesions. Progressive disease (PD) is defined as at least a 20% increase in the sum of diameters of baseline lesions, taking as reference the smallest sum on study, and an absolute increase of at least 5 mm, or the appearance of any new lesions.
Because this study was terminated with 5 patients enrolled, data for this endpoint were summarized in by-patient listings only and the cOR rate was not calculated. Therefore a summary of response at the end of study is reported."|End of trial; the maximum time on study was 20 weeks.|All randomized participants||participants|||Number
822245|NCT01161498|Primary|2-year Event-free Survival|Event-free survival is defined as the time from randomization until the first evidence of relapse, disease progression (local, regional, metastatic, or second primary), or death from any cause. Because this study was terminated with only 5 participants enrolled, and the study was terminated in the first year, this endpoint was not analyzed.|2 years||||||
822246|NCT01161537|Secondary|Part B: Absolute Change From Baseline in in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score At Week 48|The CFQ-R is a validated patient-reported outcome measuring health-related quality of life for subjects with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug in Part B (48 weeks).|Part B: Baseline (Day -1), Week 48|"FAS for Part B = all enrolled subjects who received at least 1 dose of study drug (VX-770) in Part B. Here, Number of participants analyzed signifies those subjects who were evaluable for this outcome measure."||units on a scale||Standard Deviation|Mean
822247|NCT01161537|Secondary|Part B: Absolute Change From Baseline in Sweat Chloride at Week 48|Sweat samples were collected using an approved Macroduct (Wescor, Logan, Utah) collection device. A volume of greater than or equal to (>=) 15 microliter was required for determination of sweat chloride. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug in Part B (48 weeks).|Part B: Baseline (Day -1), Week 48|"FAS for Part B = all enrolled subjects who received at least 1 dose of study drug (VX-770) in Part B. Here, Number of participants analyzed signifies those subjects who were evaluable for this outcome measure."||mmol/L||Standard Deviation|Mean
822248|NCT01161537|Secondary|Part B: Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Week 48|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Predicted FEV1 (for age, gender, and height) was calculated using the Knudson method. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug in Part B (48 weeks).|Part B: Baseline (Day -1), Week 48|"FAS for Part B = all enrolled subjects who received at least 1 dose of study drug (VX-770) in Part B. Here, Number of participants analyzed signifies those subjects who were evaluable for this outcome measure."||percent predicted of FEV1||Standard Deviation|Mean
822249|NCT01161537|Secondary|Part B: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Related AEs|"AE: any adverse change from subject’s baseline (pre-treatment) condition, including any adverse experience, abnormal recording/clinical laboratory assessment which occurs during course of study, whether it is considered related to study drug or not. SAE: medical event or condition, which falls into any of following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolonged hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect, important medical event.
Related AEs includes all AEs for which the causality was either related to study drug or possibly related to study drug."|Part B: Day 1 up to Week 48|Safety Set for Part B = all enrolled subjects who received at least 1 dose of study drug (VX-770 or placebo) in Part B.||participants|||Number
822250|NCT01161537|Secondary|Part A: Absolute Change From Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score At Day 43|The CFQ-R is a validated patient-reported outcome measuring health-related quality of life for subjects with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug in VX-770 treatment phase (Day 15 to 42).|Baseline (pre-dose Day 15), Day 43|FAS for Part A = all enrolled subjects who received at least 1 dose of study drug (VX-770 or placebo) in Part A.||units on a scale||Standard Deviation|Mean
822251|NCT01161537|Secondary|Part A: Absolute Change From Baseline in Sweat Chloride at Day 43|Sweat samples were collected using an approved Macroduct (Wescor, Logan, Utah) collection device. A volume of greater than or equal to (>=) 15 microliter was required for determination of sweat chloride. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug in VX-770 treatment phase (Day 15 to 42).|Part A: Baseline (pre-dose Day 15), Day 43|FAS for Part A = all enrolled subjects who received at least 1 dose of study drug (VX-770 or placebo) in Part A.||millimole per liter (mmol/L)||Standard Deviation|Mean
822252|NCT01161537|Secondary|Part A: Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Day 43|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Predicted FEV1 (for age, gender, and height) was calculated using the Knudson method. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug in VX-770 treatment phase (Day 15 to 42).|Part A: Baseline (pre-dose Day 15), Day 43|FAS for Part A = all enrolled subjects who received at least 1 dose of study drug (VX-770 or placebo) in Part A.||percent predicted of FEV1||Standard Deviation|Mean
822253|NCT01161537|Secondary|Part A: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Related AEs|"AE: any adverse change from subject’s baseline (pre-treatment) condition, including any adverse experience, abnormal recording/clinical laboratory assessment which occurs during course of study, whether it is considered related to study drug or not. SAE: medical event or condition, which falls into any of following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolonged hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect, important medical event.
Related AEs includes all AEs for which the causality was either related to study drug or possibly related to study drug."|Part A: Day 1 up to Day 57|Safety Set for Part A = all enrolled subjects who received at least 1 dose of study drug (VX-770 or placebo) in Part A. Data was reported as per the intervention received (Placebo [Placebo Run in/Washout] or VX-770 [VX-770 Treatment]).||participants|||Number
822254|NCT01161537|Primary|Part B: Change From Baseline in Total Ventilation Defect Defined by Hyperpolarized Helium 3 Magnetic Resonance Imaging (3He-MRI) at Week 48|Subjects were asked to inhale hyperpolarized 3 He gas mixed with nitrogen to make a total volume of approximately one-third forced vital capacity (FVC) to a maximum of 1 liter and hold their breath for 20 seconds or less. Rapid MRI was performed during inhalation/exhalation and/or breath-hold. Areas of decreased ventilation were observed as ventilation defects that are visualized as decreased (and/or absent) 3He intensity in 3He MRI. The total ventilation defect was defined as the ratio of total ventilation defect volume (L) to total lung volume (L), expressed as a percentage. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug in Part B (48 weeks).|Part B: Baseline (Day -1), Week 48|FAS for Part B = all enrolled subjects who received at least 1 dose of study drug (VX-770) in Part B.||percentage of total lung volume||Standard Deviation|Mean
822255|NCT01161537|Primary|Part A: Change From Baseline in Total Ventilation Defect Defined by Hyperpolarized Helium 3 Magnetic Resonance Imaging (3He-MRI) at Day 43|Subjects inhaled hyperpolarized helium-3 (3He) gas mixed with nitrogen to make a total volume of approximately one-third forced vital capacity (FVC) to a maximum of 1 liter and hold their breath for 20 seconds or less. Rapid magnetic resonance imaging (MRI) was performed during inhalation/exhalation and/or breath-hold. Areas of decreased ventilation were observed as ventilation defects that are visualized as decreased (and/or absent) 3He intensity in 3He-MRI. The total ventilation defect was defined as the ratio of total ventilation defect volume (L) to total lung volume (L), expressed as a percentage. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug in VX-770 treatment phase (Day 15 to 42).|Part A: Baseline (pre-dose Day 15), Day 43|FAS for Part A = all enrolled subjects who received at least 1 dose of study drug (VX-770 or placebo) in Part A.||percentage of total lung volume||Standard Deviation|Mean
822256|NCT01161563|Secondary|Discomfort From Injection|Questionnaire responses recorded on a Visual Analog Scale (VAS), which has a range of 0-100 mm, assessed approximately 15 minutes post-injection|15 minutes|Per-protocol population, defined as all subjects who receive both study drugs and complete both post-injection questionnaires.||units on a scale||95% Confidence Interval|Mean
822257|NCT01161563|Primary|Patient Bother From Injection Site Burning and/or Stinging|Questionnaire responses recorded on a Visual Analog Scale (VAS), which has a range of 0-100 mm, assessed approximately 15 minutes post-injection|15 minutes|Per-protocol population, defined as all patients who receive both study drugs and complete both post-injection questionnaires.||units on a scale||95% Confidence Interval|Mean
822258|NCT01161628|Secondary|Incidence of Non-relapse Mortality||2 years|||percentage of patients|||Number
822259|NCT01161628|Secondary|Incidence of Disease-free Survival||2 years|Of the surviving patients at 2 years (82% of initial enrolled population)||percentage of patients|||Number
822260|NCT01161628|Secondary|Duration of Systemic Corticosteroid Use||2 years|Only 2 patients out of the 22 evaluable patients enrolled received steroids during the course of treatment for cGVHD. A total of 25 patients were enrolled; 3 patients were excluded from this analysis due to treatment failure.||days||Full Range|Median
822261|NCT01161628|Primary|Rate of Partial Response of cGVHD to Treatment||2 years|||percentage of patients|||Number
822262|NCT01161628|Primary|Rate of Overall Response of cGVHD to Treatment||2 years|||percentage of patients|||Number
822263|NCT01161628|Secondary|Incidence of Overall Survival||2 years|||percentage of patients|||Number
822264|NCT01161628|Secondary|Time to Immunosuppression Withdrawal||2 years|||days||Full Range|Median
822265|NCT01161628|Secondary|Requirement for Systemic Corticosteroid Use||2 years|20 out of the 25 patients enrolled received no corticosteroids at all during the course of treatment for cGVHD||participants|||Number
822266|NCT01161628|Primary|Rate of Complete Response of cGVHD to Treatment.||2 years|||percentage of patients|||Number
822267|NCT01161771|Secondary|Change From Baseline in Schirmer's Test at Month 3|Change from baseline in Schirmer’s Test result at month 3. The Schirmer’s Test measures the rate of the secretion of tears produced by the eye over 5 minutes. The results indicate the presence of dry eye (Normal = greater than or equal to 10 millimeters (mm) of tears, Dry Eye = less than 10 mm of tears). The smaller the number, the more severe the dry eye. A positive number change from baseline indicates an increase in tears (improvement).|Baseline, Month 3|Subjects enrolled who met the inclusion criteria of having 2 limbal relaxing incisions (LRIs) during cataract extraction. Nine (9) subjects only had 1 LRI.||Millimeters of Tears||Standard Deviation|Mean
822389|NCT01155570|Primary|Psoriasis Area and Severity Index (PASI) at Week 24|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis).|Week 24|Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.||units on a scale||Standard Deviation|Mean
822268|NCT01161771|Secondary|Change From Baseline in Tear Break-Up Time at Month 3|Change from baseline in tear break-up time (TBUT) at month 3. TBUT is the time required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A short TBUT is a sign of poor tear film. A negative number change from baseline indicates a decrease in TBUT (worsening).|Baseline, Month 3|Subjects enrolled who met the inclusion criteria of having 2 limbal relaxing incisions (LRIs) during cataract extraction. Nine (9) subjects only had 1 LRI.||Seconds||Standard Deviation|Mean
822269|NCT01161771|Secondary|Change From Baseline in Conjunctival Staining at Month 3|Change from baseline in conjunctival staining severity score at month 3. The conjunctiva is the clear membrane covering the white surface of the eye. Conjunctival staining following ocular administration of lissamine green dye was graded using a 6-point scale (0= no staining, 5= severe staining) over 6 areas of the white part of the eye for a minimum score of 0 and a maximum score of 30. The higher the score, the worse the dry eye condition. A negative number change from baseline represents a decrease in the severity of conjunctival staining (improvement)|Baseline, Month 3|Subjects enrolled who met the inclusion criteria of having 2 limbal incisions (LRIs) during cataract extraction. Nine (9) subjects only had 1 LRI.||Scores on a Scale||Standard Deviation|Mean
822270|NCT01161771|Secondary|Change From Baseline in Corneal Staining at Month 3|Change from baseline in corneal staining at month 3. The cornea is the transparent front part of the eye which covers the iris and pupil. Corneal staining following administration of fluorescein dye in the eye is graded using a 6-point scale (0= no staining, 5 = severe staining) over 5 areas of the clear central part of the eye for a minimum score of 0 and a maximum score of 25. The higher the grade score, the worse the dry eye condition. A positive number change from baseline represents an increase in corneal staining (worsening of dry eye).|Baseline, Month 3|Subjects enrolled who met the inclusion criteria of having 2 limbal relaxing incisions (LRIs) during cataract extraction. Nine (9) subjects only had 1 LRI.||Scores on a Scale||Standard Deviation|Mean
822271|NCT01161771|Secondary|Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score at Month 3|Change from baseline in OSDI total score at month 3. The OSDI is a 12-question survey for subjects to document their dry eye disease symptoms. The OSDI consists of a 5-point scale (0=none of the time and 4 = all of the time), with higher scores representing greater disability. The scores are totaled over the 12 questions and converted to a score of 0-100 (0=no disability and 100=complete disability). A negative number change from baseline represents an improvement.|Baseline, Month 3|Subjects enrolled who met the inclusion criteria of having 2 limbal relaxing incisions (LRIs) during cataract extraction. Nine (9) subjects only had 1 LRI.||Scores on a Scale||Standard Deviation|Mean
822272|NCT01161771|Primary|The Percentage of Subjects at Month 3 With Corneal Sensitivity < 50 Millimeters (mm) at Any of the Locations Measured|The percentage of subjects at month 3 with corneal sensitivity < 50 mm at any of the locations measured. Corneal sensitivity is evaluated by using a nylon filament to measure the capability of the cornea (clear front portion of the eye) to respond to touch. The longest filament length at which a minimum of the 3 out of 5 stimulus applications produce a positive response from the subject was the corneal touch threshold (sensitivity). Measurements were taken at 5 different locations in each cornea.|Month 3|Subjects enrolled who met the inclusion criteria of having 2 limbal relaxing incisions (LRIs) during cataract extraction. Nine (9) subjects only had 1 LRI.||Percentage of Subjects|||Number
822273|NCT01162096|Secondary|Engraftment, Immune Reconstitution, GVHD||6 months||||||
822274|NCT01162096|Primary|Overall Survival|Number of patients alive at 6 months post-transplant|6 months|||participants|||Number
822275|NCT01162122|Secondary|Number of Subjects Reporting Solicited Adverse Events Following Vaccination|The number of subjects reporting solicited local and systemic adverse events and other adverse events in aTIV group compared to TIV group.|Day 1 through Day 7 post vaccination|Analysis was done on the safety set i.e all randomized subjects who received a study vaccination and provided postvaccination safety data.||participants|||Number
822276|NCT01162122|Secondary|All Cause Mortality Rate, Across Vaccine Groups|The all-cause mortality rate (excluding injury)reported in aTIV group compared to TIV group, by country.|Day 1 through Day 366 post vaccination|Analysis was done on the mFAS (effectiveness).||participants|||Number
822277|NCT01162122|Secondary|Number of Subjects Reporting Healthcare Utilization Across Vaccine Groups|The number of subjects with emergency room visits, unscheduled physician visits, and hospitalizations due to community acquired influenza or pneumonia, cardiopulmonary disease, cardiac disease, respiratory or pulmonary disease,in aTIV group compared to TIV group.|Day 1 through Day 366 post vaccination|Analysis was done on the mFAS (effectiveness).||participants|||Number
822278|NCT01162122|Secondary|Number of High Risk Subjects With Exacerbation of Preexisting Chronic Disease, Across Vaccine Groups|The number of high risk subjects reporting exacerbation of preexisting chronic conditions (i.e.congestive heart failure, Chronic Obstructive Pulmonary disease (COPD), asthma, hepatic disease, renal insufficiency, and neurological/neuromuscular or metabolic disorders including diabetes mellitus) in aTIV group compared to TIV group.|Day 1 through Day 366 post vaccination|Analysis was done on the mFAS (effectiveness) population.||participants|||Number
822279|NCT01162122|Secondary|Number of Subjects Reporting Influenza Like Illness (ILI) Across Vaccine Groups|The number of subjects reporting ILI from three weeks after vaccination to up to one year in aTIV group compared to TIV group, by country.|Day 22 through Day 366 post vaccination|Analysis was done on the modified full analysis set (mFAS; effectiveness) population i.e all subjects in the randomized population who received a study vaccination but excluding those who received a non-study vaccine during the follow-up phase.||participants|||Number
822280|NCT01162122|Secondary|Percentage of Subjects With Seroconversion Upto One Year After Vaccination, Against Homologous and Heterologous Strains|"The percentage of subjects demonstrating seroconversion in HI titers against homologous and heterologous strains, at six months (day 181) and one year (day 366) after vaccination with either aTIV or TIV.
Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10."|Day 181, Day 366 post vaccination|The analysis was done on the FAS (persistence) subset.||Percentage of subjects||95% Confidence Interval|Number
822460|NCT01163253|Primary|Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 36||Baseline, Month 36|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||msec||Standard Deviation|Mean
822282|NCT01162122|Secondary|Comparison of aTIV Versus TIV in Terms of Percentage of Subjects Achieving Seroconversion Against Heterologous Strains-FAS|"The superiority of HI antibody responses of aTIV compared to TIV against the heterologous vaccine strains, in overall group and in subjects with pre-defined co-morbidities (high risk subjects), was assessed in terms of percentage of subjects achieving seroconversion, at three weeks after vaccination.
Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10."|Day 22 post vaccination|Analysis was done on FAS||Percentage of subjects||95% Confidence Interval|Number
822283|NCT01162122|Secondary|Comparison of HI Antibody Responses of aTIV Versus TIV, in Terms of Percentage of Subjects Achieving Seroconversion Against Heterologous Strains-PPS|"The non-inferiority of HI antibody responses of aTIV compared to TIV against the heterologous strains, in overall group and in subjects with pre-defined co-morbidities (high risk group), assessed in terms of percentage of subjects achieving seroconversion at three weeks after vaccination.
Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10."|Day 22 postvaccination|Analysis was done on PPS.||Percentage of subjects||95% Confidence Interval|Number
822284|NCT01162122|Secondary|Comparison of aTIV Versus TIV in Terms of GMTs Against Heterologous Strains-FAS|The superiority of HI antibody responses of aTIV compared to TIV against the heterologous vaccine strains, in overall group and in subjects with pre-defined co-morbidities (high risk subjects), was assessed in terms of post vaccination GMTs at three weeks after vaccination.|Day 22 post vaccination|Analysis was done on FAS.||Titers||95% Confidence Interval|Geometric Mean
822285|NCT01162122|Secondary|Comparison of aTIV Versus TIV in Terms of GMTs Against Heterologous Strains-PPS|The non-inferiority of HI antibody responses of aTIV compared to TIV against the heterologous vaccine strains, in overall group and in subjects with pre-defined co-morbidities (high risk subjects), was assessed in terms of post vaccination GMTs at three weeks after vaccination .|Day 22 post vaccination|Analysis was done on PPS.||Titers||95% Confidence Interval|Geometric Mean
822286|NCT01162122|Secondary|Comparison of HI Antibody Responses of aTIV Versus TIV, in High Risk Group in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-FAS|"The superiority of HI antibody responses of aTIV compared to TIV, in subjects with pre-defined co-morbidities (high risk group), assessed in terms of percentage of subjects achieving seroconversion at three weeks after vaccination against the homologous vaccine strains.
Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10."|Day 22 postvaccination|Analysis was done on FAS.||Percentage of subjects||95% Confidence Interval|Number
822287|NCT01162122|Primary|Percentage of Subjects Achieving Seroconversion in HI Titers, Against Heterologous Strains|"The percentage of subjects achieving seroconversion in HI titers from baseline, in overall group and in subjects with pre-defined co-morbidities (high risk group), against heterologous strains, three weeks after vaccination with aTIV or TIV.
Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10."|Day 22 post vaccination|Analysis was done on the FAS.||Percentage of subjects||95% Confidence Interval|Number
822288|NCT01162122|Primary|Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers, Against Heterologous Strains|The GMR of post-vaccination versus pre-vaccination HI titers (day 22/day 1) in overall group and in subjects with pre-defined co-morbidities (high risk group), against heterologous strains, three weeks after vaccination with aTIV or TIV.|Day 22 post vaccination|Analysis was done on the FAS.||Ratio||95% Confidence Interval|Geometric Mean
822289|NCT01162122|Primary|Percentage of Subjects With HI Titers ≥40 Against Heterologous Strains|The percentage of subjects demonstrating HI titers ≥40, in overall group and in subjects with pre-defined co-morbidities (high risk group), against heterologous strains, three weeks after vaccination with aTIV or TIV.|Day 22 post vaccination|Analysis was done on the FAS.||Percentage of subjects||95% Confidence Interval|Number
822290|NCT01162122|Secondary|Comparison of aTIV Versus TIV in High Risk Group in Terms of GMTs Against Homologous Strains-FAS|The superiority of HI antibody responses of aTIV compared to TIV, in subjects with predefined co-morbidities (high risk group) assessed in terms of post vaccination GMTs at three weeks after vaccination against the three homologous vaccine strains.|Day 22 post vaccination|Analysis was done on FAS population.||Titers||95% Confidence Interval|Geometric Mean
822291|NCT01162122|Secondary|Comparison of HI Antibody Responses of aTIV Versus TIV, in High Risk Group in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-PPS|"The non-inferiority of HI antibody responses of ATIV compared to TIV, in subjects with pre-defined co-morbidities (high risk group), assessed in terms of percentage of subjects achieving seroconversion at three weeks after vaccination against the homologous vaccine strains.
Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10."|Day 22 post vaccination|Analysis was done on PPS.||Percentage of subjects||95% Confidence Interval|Number
822292|NCT01162122|Secondary|Comparison of aTIV Versus TIV in High Risk Group in Terms of GMTs Against Homologous Strains-PPS|The non-inferiority of HI antibody responses of ATIV compared to TIV, in subjects with pre-defined co-morbidities (high risk subjects), was assessed in terms of post vaccination GMTs at three weeks after vaccination against the three homologous vaccine strains.|Day 22 post vaccination|Analysis was done on PPS.||Titers||95% Confidence Interval|Geometric Mean
822293|NCT01162122|Primary|Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains|The GMR of post-vaccination versus pre-vaccination HI titers (day 22/day 1) in overall group and in subjects with pre-defined co-morbidities (high risk group), against homologous strains, three weeks after vaccination with aTIV or TIV.|Day 22 post vaccination|Analysis was done on the FAS||Ratio||95% Confidence Interval|Geometric Mean
822294|NCT01162122|Primary|Percentage of Subjects Achieving Seroconversion in HI Titers, Against Homologous Strains|"The percentage of subjects achieving seroconversion in HI titers from baseline, in overall group and in subjects with pre-defined co-morbidities (high risk group), against homologous strains, three weeks after vaccination with aTIV or TIV.
Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10."|Day 22 post vaccination|Analysis was done on the FAS.||Percentage of subjects||95% Confidence Interval|Number
822296|NCT01162122|Primary|Comparison of aTIV Versus TIV in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-FAS|"The superiority of HI antibody responses of aTIV compared to TIV assessed in terms of percentage of subjects achieving seroconversion at three weeks after vaccination against the three homologous vaccine strains.
Seroconversion defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10."|Day 22 post vaccination|Analysis was done on FAS.||Percentage of subjects||95% Confidence Interval|Number
822297|NCT01162122|Primary|Comparison of aTIV Versus TIV in Terms of GMTs Against Homologous Strains-Full Analysis Set (FAS)|The superiority of HI antibody responses of aTIV compared to TIV assessed in terms of post vaccination GMTs at three weeks after vaccination against the three homologous vaccine strains.|Day 22 post vaccination|Analysis was done on FAS i.e all randomized subjects who received a study vaccination and provided evaluable serum samples both at day 1 and at day 22||Titers||95% Confidence Interval|Geometric Mean
822298|NCT01162122|Primary|Comparison of aTIV Versus TIV in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-PPS|"The non-inferiority of HI antibody responses of aTIV compared to TIV assessed in terms of percentage of subjects achieving seroconversion at three weeks after vaccination against the three homologous vaccine strains.
Seroconversion defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10."|Day 22 post vaccination|Analysis was done on PPS.||Percentage of subjects||95% Confidence Interval|Number
822299|NCT01162122|Primary|Comparison of aTIV Versus TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains - PPS|The non-inferiority of HI antibody responses of aTIV compared to TIV assessed in terms of post vaccination GMTs at three weeks after vaccination against the three homologous vaccine strains.|Day 22 post vaccination|Analysis was done on PPS.||Titers||95% Confidence Interval|Geometric Mean
822300|NCT01162122|Primary|Geometric Mean Titers in Subjects After Receiving One Dose of Lot 1 or Lot 2 or Lot 3 of aTIV|Immunologic equivalence of 3 consecutive production lots of aTIV (Lot 1, Lot 2 and Lot 3), was assessed in terms of Hemagglutination Inhibition (HI) Geometric Mean Titers (GMTs) in subjects, at three weeks after vaccination, against each vaccine strain.|Day 22 post vaccination|Analysis was done on the per protocol set population (PPS) i.e all randomised subjects who received the correct vaccine, provided evaluable serum samples, and had no major protocol deviation prior to unblinding.||Titers||95% Confidence Interval|Geometric Mean
822301|NCT01162135|Primary|Rate of Positive PSADT Outcome|Proportion of patients at 6 months post-treatment with a PSADT >= 200% from baseline|6 months after treatment with digoxin|||participants|||Number
822302|NCT01162304|Secondary|Patient Global Impression of Change|This rating on a 7-point scale measures a patients overall assessment of change since starting a given treatment. This measure provides a subjects global assessment of change, presumably including change in pain, side effects, change in functional status, convenience of therapy, subject preference and values and overall satisfaction with the intervention.|Visits 4 and 6 the end of each of the two treatment periods|Due to not reaching enrollment goal of 40 subjects, data collected on the 7 participants enrolled was not analyized because the data is not available the data are locked not able to obtain.|||||
822303|NCT01162304|Secondary|Short Form Health Survey (SF-36)|It is a 36-item questionnaire designed to measure general health related quality of life.|Visits 2, 4 and 6|Due to not reaching enrollment goal of 40 subjects, data collected on the 7 participants enrolled was not analyized because the data is not available the data are locked not able to obtain.|||||
822304|NCT01162304|Secondary|Hospital Anxiety and Depression Scale|The HADS will be administered to assess anxiety and depression.|Visits 2-6|Due to not reaching enrollment goal of 40 subjects, data collected on the 7 participants enrolled was not analyized because the data is not available the data are locked not able to obtain.|||||
822305|NCT01162304|Secondary|Brief Pain Inventory|Will be administered to assess the extent to which chronic pain interferes with sleep and physical and emotional functioning.|Visits 2-6|Due to not reaching enrollment goal of 40 subjects, data collected on the 7 participants enrolled was not analyized because the data is not available the data are locked not able to obtain.|||||
822306|NCT01162304|Primary|Numerical Pain Rating Scale (NRS)|The primary outcome measure for this clinical trial will be pain relief documented in the subjects' daily pain diaries. Specifically, the average of the daily pain ratings recorded by subjects during the final weeks of the two treatment periods will be compared. The treatment comparison of interest is IR-oxycodone vs. ER-oxycodone, which will be tested at the p < 0.05 level using a two-tailed test.|Daily|Due to not reaching enrollment goal of 40 subjects, data collected on the 7 participants enrolled was not analyized because the data is not available the data are locked not able to obtain.|||||
822307|NCT01162317|Secondary|Wrist Actigraphy (an Objective Sleep Measure) Sleep Efficiency|Wrist actigraphy is a non-invasive method of continuously monitoring gross body activities when a watch-like actimetry sensor is worn at the non-dominant wrist. An algorithm has been developed to assess sleep/wake behavior. Specifically in this study, we used Respironics® actiwatches for data collection. Subjects were asked to wear the actiwatches for a consecutive week at baseline and then at post-intervention, and the actiwatches were taken off only during showers. Wrist actigraphy was examined in association with sleep diary the subjects were to keep for the weeks of monitoring. Threshold-based method algorithm for data interpretation was provided by Respironics® Actiware Software. Medium level threshold was set to detect Wake and Sleep; sleep interval detection algorithm was set for 3 minutes of immobile minutes for Sleep Onset and 5 minutes of immobile minutes for Sleep End. Sleep efficiency is sleep duration divided by total bed time (both in minutes), times 100%.|pre-intervention, post-intervention (1wk of recording each)|All obtained actigraphy data were analyzed. This form doesn't allow specific indication of sample sizes. Therefore, here overall numbers of participants analyzed were the same as the maximal potential.||percentage||Standard Deviation|Mean
822308|NCT01162317|Primary|PSQI Change|"change of global PSQI score as compared to baseline The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval.
The PSQI global score has a possible range of 0–21 points. Any score above 5 is considered insomnia. The higher the score the worse the condition."|Baseline and post-intervention|||change of points from baseline||Standard Deviation|Mean
823286|NCT01170663|Secondary|Cmax After 4th Ramucirumab (IMC-1211B) Infusion||Cycle 2, Day 15 1 hour post end of infusion (28-day cycles)|All participants who received Ramucirumab (IMC-1121B) plus Paclitaxel and had Cmax observations at specific timepoint.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
822309|NCT01162421|Secondary|HCR: Out of Pocket Expenses Incurred for the Current Study Condition in the Past 4 Weeks at Final Visit|The HCR consists of four aspects: medical insurance, health care for RA in the past 4 weeks, hospitalization in the past 4 weeks, and out of pocket expenses incurred for the current study condition. Participants were asked what type of out-of-pocket expenses they had incurred for their RA in the past 4 weeks. Based on Canadian dollars.|Final Visit (up to Month 24)|Intent-to-treat population: all participants who were randomized, received at least one dose of study drug, and had an assessment. n=participants with non-zero expenses for given category, and included in the mean (SD) calculation.||Canadian dollars||Standard Deviation|Mean
822310|NCT01162421|Secondary|HCR: Out of Pocket Expenses Incurred for the Current Study Condition in the Past 4 Weeks at Baseline|The HCR consists of four aspects: medical insurance, health care for RA in the past 4 weeks, hospitalization in the past 4 weeks, and out of pocket expenses incurred for the current study condition. Participants were asked what type of out-of-pocket expenses they had incurred for their RA in the past 4 weeks. Based on Canadian dollars.|Baseline|Intent-to-treat population: all participants who were randomized, received at least one dose of study drug, and had an assessment. n=participants with non-zero expenses for given category, and included in the mean (SD) calculation.||Canadian dollars||Standard Deviation|Mean
822311|NCT01162421|Secondary|HCR: Health Care for RA in the Past 4 Weeks at Final Visit|The HCR consists of four aspects: medical insurance, health care for RA in the past 4 weeks, hospitalization in the past 4 weeks, and out of pocket expenses incurred for the current study condition. Participants were asked about their use of health care for RA in the past 4 weeks.|Final Visit (up to Month 24)|Intent-to-treat population: all participants who were randomized, received at least one dose of study drug, and had an assessment. n=the number of participants included in the percentage calculation (n=2, 3 is the number of participants who stated that they had used healthcare for RA in the past 4 weeks).||percentage of participants|||Number
822312|NCT01162421|Secondary|HCR: Health Care for RA in the Past 4 Weeks at Baseline|The HCR consists of four aspects: medical insurance, health care for RA in the past 4 weeks, hospitalization in the past 4 weeks, and out of pocket expenses incurred for the current study condition. Participants were asked about their use of health care for RA in the past 4 weeks.|Baseline|Intent-to-treat population: all participants who were randomized, received at least one dose of study drug, and had an assessment. n=the number of participants included in the percentage calculation (n=11, 10 is the number of participants who stated that they had used healthcare for RA in the past 4 weeks).||percentage of participants|||Number
822313|NCT01162421|Secondary|HCR: Medical Insurance at Final Visit|The HCR consists of four aspects: medical insurance, health care for RA in the past 4 weeks, hospitalization in the past 4 weeks, and out of pocket expenses incurred for the current study condition. Participants were asked whether and what type of health insurance they had. Types of Canadian insurance included: Régie de l’assurance maladie du Québec (RAMQ); Société de l'assurance automobile du Québec (SAAQ); Commission de la santé et de la sécurité du travail (CSST); Canadian Health Insurance Program (CHIP); and L’indemnisation des victimes d’actes criminals (IVAC).|Final Visit (up to Month 24)|Intent-to-treat population: all participants who were randomized, received at least one dose of study drug, and had an assessment. n=the number of participants included in the percentage calculation (n=26, 26 is the number of participants who answered that they did have health insurance).||percentage of participants|||Number
822314|NCT01162421|Secondary|Health Care Resources Questionnaire (HCR): Medical Insurance at Baseline|The HCR consists of four aspects: medical insurance, health care for RA in the past 4 weeks, hospitalization in the past 4 weeks, and out of pocket expenses incurred for the current study condition. Participants were asked whether and what type of health insurance they had. Types of Canadian insurance included: Régie de l’assurance maladie du Québec (RAMQ); Société de l'assurance automobile du Québec (SAAQ); Commission de la santé et de la sécurité du travail (CSST); Canadian Health Insurance Program (CHIP); and L’indemnisation des victimes d’actes criminals (IVAC).|Baseline|Intent-to-treat population: all participants who were randomized, received at least one dose of study drug, and had an assessment. n=the number of participants included in the percentage calculation (n=25, 28 is the number of participants who answered that they did have health insurance).||percentage of participants|||Number
822315|NCT01162421|Secondary|Likert Scale for Participant's Satisfaction With Care at Months 3, 6, 9, 12, 18 and 24|"Participants measured their satisfaction with care by specifying their in response to the question How satisfied are you with the results of your RA treatment? on a 5-point Likert scale, from the following 5 answers: not satisfied, a little satisfied, moderately satisfied, well satisfied, very well satisfied. Scores range from 1 to 5, with higher scores indicating more satisfaction with their care."|Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug and had an assessment. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation.||units on a scale||Standard Error|Least Squares Mean
822316|NCT01162421|Secondary|Change From Baseline in Beck Depression Inventory (BDI-II) Scores at Months 3, 6, 9, 12, 18 and 24|BDI is a 21-item questionnaire, participant self-report rating inventory that measures characteristic attitudes and symptoms of depression. The range of scores is 0 to 63, with a higher value representing a worse outcome.|Baseline, Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug and had an assessment. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation.||units on a scale||Standard Error|Least Squares Mean
822317|NCT01162421|Secondary|Change From Baseline in EQ-5D VAS at Months 3, 6, 9, 12, 18 and 24|The EQ-5D VAS records the participant's self-rated health on a scale from 0-100 where 100 is the 'best imaginable health state' and 0 is the 'worst imaginable health state.'|Baseline, Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug and had an assessment. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation.||units on a scale||Standard Error|Least Squares Mean
822390|NCT01155570|Primary|Psoriasis Area and Severity Index (PASI) at Week 16|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis).|Week 16|Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.||units on a scale||Standard Deviation|Mean
822318|NCT01162421|Secondary|Change From Baseline in EuroQOL Questionnaire (EQ-5D) Index Score at Months 3, 6, 9, 12, 18 and 24|The EQ-5D is a participant answered questionnaire scoring 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that essentially attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.594 to 1 (with higher scores indicating better health state).|Baseline, Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation; n=number of participants with an assessment at given time point.||units on a scale||Standard Error|Least Squares Mean
822319|NCT01162421|Secondary|Change From Baseline in Work Limitations Questionnaire (WLQ) at Months 3, 6, 9, 12, 18 and 24|The WLQ was used to measure the impairment in work-related productivity, with reference to the previous two weeks. Each work-related question is scored from 0 to 4 and the total score ranges from 0-100, with lower scores signifying fewer limitations at work.|Baseline, Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation; n=number of participants with an assessment at given time point.||units on a scale||Standard Error|Least Squares Mean
822320|NCT01162421|Secondary|Percentage of Participants Achieving MCID in FACIT-Fatigue Scale at Months 3, 6, 9, 12, 18 and 24|The FACIT-Fatigue questionnaire is a self-administered patient questionnaire that consists of 13 questions designed to measure the degree of fatigue experienced by participants in the previous 7 days. Participants respond to the questions on a scale from 'not at all' (0) to 'very much' (4). The scale score is computed by summing the item scores, after reversing those items that are worded in the negative direction. The FACIT-Fatigue subscale score ranges from 0 to 52, where higher scores represent less fatigue. The MCID was defined as a 3.56-unit decrease in FACIT-Fatigue Scale.|Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment (non-responder imputation).||percentage of participants|||Number
822321|NCT01162421|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale at Months 3, 6, 9, 12, 18 and 24|The FACIT-Fatigue questionnaire is a self-administered patient questionnaire that consists of 13 questions designed to measure the degree of fatigue experienced by participants in the previous 7 days. Participants respond to the questions on a scale from 'not at all' (0) to 'very much' (4). The scale score is computed by summing the item scores, after reversing those items that are worded in the negative direction. The FACIT-Fatigue subscale score ranges from 0 to 52, where higher scores represent less fatigue.|Baseline, Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation.||units on a scale||Standard Error|Least Squares Mean
822322|NCT01162421|Secondary|Percentage of Participants Achieving HAQ < 0.5 at Months 3, 6, 9, 12, 18 and 24|The percentage of participants achieving HAQ < 0.5. HAQ is a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. HAQ remission indicating normal physical function is defined by HAQ-DI < 0.5. A lower HAQ-DI score is better.|Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment (non-responder imputation).||percentage of participants|||Number
822323|NCT01162421|Secondary|Percentage of Participants Achieving Minimal Clinical Important Difference (MCID) in HAQ at Months 3, 6, 9, 12, 18 and 24|The percentage of participants achieving MCID in HAQ, defined as a 0.22 unit decrease in HAQ. HAQ is a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A lower HAQ-DI score is better.|Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment (non-responder imputation).||percentage of participants|||Number
822324|NCT01162421|Secondary|Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ-DI) at Months 3, 6, 9, 12, 18 and 24|HAQ is a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A lower HAQ-DI score is better.|Baseline, Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation.||units on a scale||Standard Error|Least Squares Mean
822325|NCT01162421|Secondary|Percentage of Participants With Flare-Up After Remission by Month 24|Percentage of participants with a flare-up after remission by Month 24, defined as participants who reached remission (DAS28 < 2.6) but later had two consecutive visits with DAS28 ≥ 2.6 (based on observed cases only). The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.|Month 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug and had an assessment.||percentage of participants|||Number
822326|NCT01162421|Secondary|Percentage of Participants With EULAR Moderate Response at Months 3, 6, 9, 12, 18 and 24|A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS28 score. The DAS28 score ranges from 0-10, with higher scores indicating more disease activity. A Moderate EULAR Response is defined as either: an improvement (decrease) in the DAS28 of > 0.6 and < 1.2 from Baseline and attainment of a DAS28 score of ≤ 5.1; or an improvement (decrease) in the DAS28 of ≥ 1.2 from Baseline and attainment of a DAS28 score of > 3.2.|Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment (non-responder imputation).||percentage of participants|||Number
822327|NCT01162421|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Good Response at Months 3, 6, 9, 12, 18 and 24|A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS28 score. The DAS28 score ranges from 0-10, with higher scores indicating more disease activity. A Good EULAR Response is defined as an improvement (decrease) in the DAS28 of ≥ 1.2 compared with Baseline and attainment of a DAS28 score of ≤ 3.2.|Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment (non-responder imputation).||percentage of participants|||Number
822328|NCT01162421|Secondary|Percentage of Participants With DAS28(CRP) Low Disease Activity at Months 3, 6, 9, 12, 18 and 24|DAS28(CRP) low disease activity was defined as DAS28(CRP) < 3.2. The DAS28(CRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.|Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment (non-responder imputation).||percentage of participants|||Number
822329|NCT01162421|Secondary|Percentage of Participants With DAS28(CRP) Remission at Months 3, 6, 9, 12, 18 and 24|DAS28(CRP) remission was defined as DAS28(CRP) < 2.6. The DAS28(CRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.|Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment (non-responder imputation).||percentage of participants|||Number
822330|NCT01162421|Secondary|Change From Baseline in Disease Activity Score DAS28(CRP) at Months 3, 6, 9, 12, 18 and 24|The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.|Baseline, Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation; n=number of participants with an assessment at given time point.||units on a scale||Standard Error|Least Squares Mean
822331|NCT01162421|Secondary|Change From Baseline in CRP at Months 3, 6, 9, 12, 18 and 24||Baseline, Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation; n=number of participants with an assessment at given time point.||mg/L||Standard Error|Least Squares Mean
822332|NCT01162421|Secondary|Change From Baseline in Patient's Global Assessment of Pain at Months 3, 6, 9, 12, 18 and 24|Participants were asked to indicate how severe their pain had been in the previous week on a VAS from 0 (no pain) to 100 (pain as bad as it could be). A negative change from Baseline indicates improvement.|Baseline, Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation.||units on a scale||Standard Error|Least Squares Mean
822333|NCT01162421|Secondary|Change From Baseline in Patient's Global Assessment of Disease Activity at Months 3, 6, 9, 12, 18 and 24|Participants were asked to indicate how they were doing with their RA on a VAS from 0 (very well) to 100 (very poorly). A negative change from Baseline indicates improvement.|Baseline, Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation.||units on a scale||Standard Error|Least Squares Mean
822334|NCT01162421|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity at Months 3, 6, 9, 12, 18 and 24|Physicians were asked to indicate the participant’s disease activity (independent of the participant's self assessment) on a visual analogue scale (VAS) from 0 (very good) to 100 (very bad). A negative change from Baseline indicates improvement.|Baseline, Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation.||units on a scale||Standard Error|Least Squares Mean
822335|NCT01162421|Secondary|Change From Baseline in Tender Joint Count 28 at Months 3, 6, 9, 12, 18 and 24|Twenty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination. The presence of tenderness is scored 1 and no tenderness is 0; range of score is 0-28, with higher scores indicating more tender joints.|Baseline, Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation.||tender joints||Standard Error|Least Squares Mean
822336|NCT01162421|Secondary|Change From Baseline in Tender Joint Count 68 at Months 3, 6, 9, 12, 18 and 24|Sixty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination. The presence of tenderness is scored 1 and no tenderness is 0; range of score is 0-68, with higher scores indicating more tender joints.|Baseline, Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation.||tender joints||Standard Error|Least Squares Mean
822337|NCT01162421|Secondary|Change From Baseline in Swollen Joint Count 28 at Months 3, 6, 9, 12, 18 and 24|Twenty-eight joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination. The presence of swelling is scored 1 and no swelling is 0; range of score is 0-28, with higher scores indicating more swollen joints.|Baseline, Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation.||swollen joints||Standard Error|Least Squares Mean
822338|NCT01162421|Secondary|Change From Baseline in Swollen Joint Count 66 at Months 3, 6, 9, 12, 18 and 24|Sixty-six joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination. The presence of swelling is scored 1 and no swelling is 0; range of score is 0-66, with higher scores indicating more swollen joints.|Baseline, Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation.||swollen joints||Standard Error|Least Squares Mean
822339|NCT01162421|Secondary|Percentage of Participants With American College of Rheumatology 70% (ACR70) Response at Months 3, 6, 9, 12, 18 and 24|"A participant is an ACR70 responder if the following 3 criteria for improvement from Baseline are met:
≥ 70% improvement in tender joint count;
≥ 70% improvement in swollen joint count; and
≥ 70% improvement in at least 3 of the 5 following parameters: -
Physician global assessment of disease activity
Patient global assessment of disease activity
Patient assessment of pain
Disability Index of the Health Assessment Questionnaire
Acute phase reactant (erythrocyte sedimentation rate/CRP)."|Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug (nonresponder imputation).||percentage of participants|||Number
822340|NCT01162421|Secondary|Percentage of Participants With American College of Rheumatology 50% (ACR50) Response at Months 3, 6, 9, 12, 18 and 24|"A participant is an ACR50 responder if the following 3 criteria for improvement from Baseline are met:
≥ 50% improvement in tender joint count;
≥ 50% improvement in swollen joint count; and
≥ 50% improvement in at least 3 of the 5 following parameters:
Physician global assessment of disease activity
Patient global assessment of disease activity
Patient assessment of pain
Disability Index of the Health Assessment Questionnaire
Acute phase reactant (erythrocyte sedimentation rate/CRP)."|Baseline, Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug (nonresponder imputation).||percentage of participants|||Number
822341|NCT01162421|Secondary|Percentage of Participants With American College of Rheumatology 20% (ACR20) Response at Months 3, 6, 9, 12, 18 and 24|"A participant is an ACR20 responder if the following 3 criteria for improvement from Baseline are met:
≥ 20% improvement in tender joint count;
≥ 20% improvement in swollen joint count; and
≥ 20% improvement in at least 3 of the 5 following parameters: -
Physician global assessment of disease activity
Patient global assessment of disease activity
Patient assessment of pain
Disability Index of the Health Assessment Questionnaire
Acute phase reactant (erythrocyte sedimentation rate/C-reactive protein [CRP])."|Baseline, Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug (nonresponder imputation).||percentage of participants|||Number
822342|NCT01162421|Secondary|Percentage of Participants With Rapid Radiographic Progression at Month 12|Radiographic progression was defined as a change from Baseline in mTSS that is ≥ 5 units. The mTSS is a measure of change in joint health: digitized images of radiographs of hands and feet obtained at Screening and Month 12 were scored in a blinded manner. Joints were scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.|Month 12|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug ith an assessment (nonresponder imputation).||percentage of participants|||Number
822343|NCT01162421|Secondary|Change From Baseline in mTSS at Months 6, 12 and 24|The mTSS is a measure of change in joint health: digitized images of radiographs of hands and feet obtained at Screening and Month 12 were scored in a blinded manner. Joints were scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.|Baseline, Month 6, Month 12, Month 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug; n=number of participants with an assessment at Baseline and given timepoint (observed cases).||units on a scale||Standard Error|Least Squares Mean
822344|NCT01162421|Secondary|Percentage of Participants With No Radiographic Progression at Month 6 and Month 24|Radiographic progression was defined as change from Baseline in the modified Total Sharp Score (mTSS) of ≤ 0.5 units). The mTSS is a measure of change in joint health: digitized images of radiographs of hands and feet obtained at Screening and Month 12 were scored in a blinded manner. Joints were scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.|Baseline, Month 6, Month 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug (nonresponder imputation).||percentage of participants|||Number
822388|NCT01155570|Primary|Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Week 16|PASI75 is defined as at least a 75% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0 (best) to 72 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 16 PASI score) divided by Week 0 PASI score.|Baseline and Week 16|Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.||percentage of participants|||Number
822345|NCT01162421|Primary|Percentage of Participants With No Radiographic Progression at Month 12|Radiographic progression was defined as change from Baseline in the modified Total Sharp Score (mTSS) of ≤ 0.5 units). The mTSS is a measure of change in joint health: digitized images of radiographs of hands and feet obtained at Screening and Month 12 were scored in a blinded manner. Joints were scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.|Baseline, Month 12|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug. Last observation carried forward (LOCF): missing responses were imputed by carrying forward the last non-missing post-baseline observation.||percentage of participants|||Number
822346|NCT01162473|Primary|Number of Subjects Who Completed Desensitization Protocol|"Subjects who withdrew prior to completing the desensitization protocol and those who experienced anaphylaxis during the desensitization protocol (i.e., were unable to complete the protocol) were considered to be treatment failures. Subjects who completed the desensitization protocol were considered to be treatment successes."|1 year|The analysis population included all subjects who began desensitization per protocol.||participants|||Number
822352|NCT01162733|Primary|Percentage of Participants First Achieving Therapeutic Levels at 12 Hours|Percentage of patients reaching a therapeutic level defined as greater than 15 mcg/mL|12 hours|||percentage of participants|||Number
822353|NCT01162733|Primary|Percentage of Participants First Achieving Therapeutic Levels at 36 Hours|The objective is to determine if therapeutic levels were reached more rapidly with the implementation of an initial vancomycin loading dose of 30 mg/kg as compared to 15mg/kg.|36 hours|||percentage of participants|||Number
822354|NCT01155466|Secondary|"Change From Baseline at Week 12 in Mean On Time Without Troublesome Dyskinesia"|"When a participant is on without dyskinesias, parkinsonian symptoms have dissipated and the participant is experiencing no uncontrollable extraneous movements. Study participants reported their parkinsonian symptoms at half-hour intervals as off, on without dyskinesia, on with non-troublesome dyskinesia, on with troublesome dyskinesia, or asleep on their daily diary for 3 days before randomization and for the 3 days immediately before their Week-12 visit. The mean change from baseline in on without troublesome dyskinesia time was based on a constrained longitudinal data analysis with treatment, time, and treatment-by-time interaction as fixed effects and subject as random effect."|Baseline and Week 12|The number of randomized and treated participants with at least one post baseline value.||Hours/day||Standard Error|Mean
822355|NCT01155466|Secondary|"Percentage of Participants With >30% Change (Reduction) From Baseline at Week 12 in Mean Off Time"|"The on state is defined as the period of time during which a patient's symptoms of PD improve or disappear following treatment with L-dopa or dopamine agonists. The off state is defined as the period of time characterized by the return of symptoms (i..e. tremor, slowness, and rigidity) following treatment with L-dopa or dopamine agonists. Study participants reported their symptoms at half-hour intervals as off, on, or asleep on their daily diary for 3 days before randomization and for the 3 days immediately before their Week-12 visit."|Baseline and Week 12|The number of randomized and treated participants with a Week 12 value.||Percentage of participants|||Number
822356|NCT01155466|Primary|Change From Baseline at Week 12 in Epworth Sleepiness Scale (ESS)|The ESS is a self-administered questionnaire providing a measure of a person’s general level of daytime sleepiness, or their average sleep propensity in daily life. The scale consists of 8 situations in which the participant rates their tendency to become sleepy on a scale of 0=no chance of dozing to 3=high chance of dozing. The overall score is the sum of the scores for the 8 situations for a minimum of 0 and a maximum of 24.|Baseline and Week 12|The number of participants who received at least one dose of study drug and had baseline and Week 12 data||Scores on a scale||Standard Deviation|Mean
822357|NCT01155466|Primary|Percentage of Participants With Suicidality|The percentage of participants with suicidality using the Columbia - Suicide Severity Rating Scale (C-SSRS) was reported. The C-SSR was used in this study only for the purpose of safety monitoring by measuring the incidence of different types of suicidality categories during treatment. The assessment was done by the nature of the responses, not by a numbered scale. Participants who reported at least one occurrence of suicidal behavior or suicidal ideation were counted as having experienced suicidality. Suicidal behavior included suicide attempt, aborted attempt, interrupted attempt, or preparatory behavior. Suicidal ideation included a wish to die or active suicidal thought with or without method, intent or plan.|Up to Week 12|The number of participants who received at least one dose of study drug||Percentage of participants|||Number
822358|NCT01155466|Primary|Number of Participants With Aspartate Aminotransferase >=3 Times the Upper Limit of Normal|The number of participants with aspartate aminotransferase >=3 times the upper limit of normal and a >=10% increase was reported.|Up to Week 14|The number of participants who received at least one dose of study drug||Participants|||Number
822359|NCT01155466|Primary|Number of Participants With Alanine Aminotransferase >=3 Times the Upper Limit of Normal|The number of participants with alanine aminotransferase >=3 times the upper limit of normal and a >=10% increase was reported.|Up to Week 14|The number of participants who received at least one dose of study drug||Participants|||Number
822360|NCT01155466|Primary|Number of Participants With Diastolic Blood Pressure >=105 mm Hg|The number of participants with Diastolic Blood Pressure >=105 mm Hg was reported.|Up to Week 14|The number of participants who received at least one dose of study drug||Participants|||Number
822361|NCT01155466|Primary|Numberof Participants With Systolic Blood Pressure >=180 mm Hg|The number of participants with Systolic Blood Pressure >=180 mm Hg was reported.|Up to Week 14|The number of participants who received at least one dose of study drug||Participants|||Number
822362|NCT01155466|Primary|"Change From Baseline in Mean Off Time"|"The on state is defined as the period of time during which a patient's symptoms of PD improve or disappear following treatment with L-dopa or dopamine agonists. The off state is defined as the period of time characterized by the return of symptoms (i..e. tremor, slowness, and rigidity) following treatment with L-dopa or dopamine agonists. Study participants reported their symptoms at half-hour intervals as off, on, or asleep on their daily diary for 3 days before randomization (baseline) and for the 3 days immediately before their Week-12 visit. The mean change from baseline in off time was based on a constrained longitudinal data analysis with treatment, time, and treatment-by-time interaction as fixed effects and subject as random effect."|Baseline and Week 12|The number of randomized and treated participants with at least one post baseline value.||Hours/day||Standard Error|Mean
822363|NCT01155479|Primary|Number of Participants Who Discontinued Study Due to an AE in Part 2|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.|Week 27 to Week 52|All Participants as Treated (APaT): All participants who received at least one dose of study treatment.||Participants|||Number
822364|NCT01155479|Primary|Number of Participants With Adverse Events (AEs) in Part 2|An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.|Week 27 to Week 52|All Participants as Treated: All participants who received at least one dose of study treatment.||Participants|||Number
822365|NCT01155479|Primary|Number of Participants Who Discontinued Study Due to an AE in Part 1|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.|Day 1 to Week 26|All Participants as Treated: All participants who received at least one dose of study treatment.||Participants|||Number
822366|NCT01155479|Primary|Number of Participants With Adverse Events (AEs) in Part 1|An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.|Day 1 to Week 26|All Participants as Treated: All participants who received at least one dose of study treatment.||Participants|||Number
824510|NCT01175018|Secondary|Difference Between the Anakinra Arm and the Placebo Arm in Change in Left Ventricular Ejection Fraction Values From Baseline to Follow up Exam at Cardiac Magnetic Resonance Imaging||10-14 weeks|||% (absolute change)||Inter-Quartile Range|Median
822367|NCT01155479|Secondary|Change From Baseline in the UPDRS Part 2 Score (Activities of Daily Living [ADL])|The UPDRS is a clinician based rating scale used to measure motor impairments and disability. The UPDRS assesses six features of PD impairment. These are evaluated using a combination of data collected by interview and examination of the participant. The UPDRS Part 2 is the Activities of Daily Living (ADL) score and can range from 0-52 as determined by the physician with the higher score indicating the worse condition. Change from baseline was analyzed using a cLDA model with treatment, time, strata and treatment-by-time interaction as fixed effects and participant as a random effect.|Baseline and Week 26|Full Analysis Set (FAS): All randomized and treated participants with at least one post-baseline value.||Score on a Scale||Standard Error|Mean
822368|NCT01155479|Secondary|Percentage of Responders (Participants With a ≥20% Improvement in UPDRS2+3)|UPDRS is a clinician based rating scale used to measure motor impairments and disability; it assesses 6 features of PD impairment. These are evaluated using a combination of data collected by interview and examination of the participant. UPDRS Part 2 is Activities of Daily Living score and ranges from 0-52. UPDRS Part 3 is Motor Examination and ranges from 0-108. The combined scores of Parts 2 and 3 can range from 0-160 with the higher score indicating the worse condition. A Responder is defined as a participant with at least 20% improvement in UPDRS2+3 from Baseline to Week 26 (End of Part 1 Treatment); a participant with at least a 20% decrease from Baseline score in UPDRS2+3 is defined as a responder. The proportion of Responders was analyzed using a generalized linear mixed model with treatment effect, strata and Baseline UPDRS2+3 as a covariate, and treatment-by-time interaction as fixed effects and subject as random effect.|Baseline and Week 26|Full Analysis Set (FAS): All randomized and treated participants with at least one post-baseline value.||Percentage of Responders||95% Confidence Interval|Number
822369|NCT01155479|Primary|Change From Baseline in the Sum of Unified Parkinson’s Disease Rating Scale Parts 2 and 3 Scores (UPDRS2+3)|The UPDRS is a clinician based rating scale used to measure motor impairments and disability. The UPDRS assesses six features of PD impairment. These are evaluated using a combination of data collected by interview and examination of the participant. The UPDRS Part 2 is the Activities of Daily Living (ADL) score and can range from 0-52 as determined by the physician. The UPDRS Part 3 is the Motor Examination (Total Motor Score [TMS]) and is defined as the total score, ranging from 0-108 as determined by the physician, of the tests given in the motor examination section. The combined scores of Parts 2 and 3 can range from 0-160 with the higher score indicating the worse condition. Change from baseline was analyzed using a constrained longitudinal analysis (cLDA) model with treatment, time, strata and treatment-by-time interaction as fixed effects and participant as a random effect.|Baseline and Week 26|Full Analysis Set (FAS): All randomized and treated participants with at least one post-baseline value.||Score on a Scale||Standard Error|Mean
822370|NCT01155531|Primary|Safety of Sertraline and Telenzepine Combination|safety of the drug combination was measured in terms of number of adverse events during the study period.|7 days|||number of adverse events|||Number
822371|NCT01155531|Primary|Changes in the Meal Calories Consumed|The changes in the meal calories consumed was measured upon telenzepine treatment at the dose of 1 mg, 2 mg and 3 mg (i.e. end of every 7 days). The baseline was defined as on day 7 of sertraline treatment with no telenzepine for the specified meal. Food consumption was measured as calories consumed for breakfast, lunch, and dinner for all treatment groups on day 7 of each dose combination.|The baseline was defined as on day 7 of sertraline treatment with no telenzepine. Food consumption was measured as calories consumed for breakfast, lunch, and dinner for all treatment groups on day 7 of each dose combination.|||calorie||Standard Deviation|Mean
822372|NCT01155531|Primary|Changes in the VAS Score From Baseline.|The baseline VAS self-assessment was completed for each subject on day 7 of each dose combination. Appetite VAS was completed in the subject’s room approximately 30 min before and 1 h after each meal serving. Appetite was not assessed prior to snacks. VAS assessment was based on response to the question: “How hungry are you now?” The anchor points of the 100mm scale were “I am not hungry at all” and “Never more hungry” corresponding to 0 mm and 100 mm respectively. The subjects’ VAS scores were measured by the clinic staff and entered into the CRF. The description listed below (VAS after meal minus and VAS before meal) refers only to the mean VAS score of each group.|The baseline was defined on day 7 of sertraline treatment with no telenzepine before and meal. Appetite VAS was measured 30 min before and 1hour after to meal|||mm||Standard Deviation|Mean
822373|NCT01155570|Primary|Disease Activity Score 28-4, C-reactive Protein (DAS28-4 [CRP]) at Week 24|DAS28-4 (CRP) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein (CRP) level, and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity.|Week 24|Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point.||units on a scale||Standard Deviation|Mean
822374|NCT01155570|Primary|Disease Activity Score 28-4, C-reactive Protein (DAS28-4 [CRP]) at Week 16|DAS28-4 (CRP) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein (CRP) level, and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity.|Week 16|Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point.||units on a scale||Standard Deviation|Mean
822375|NCT01155570|Primary|Disease Activity Score 28-4, C-reactive Protein (DAS28-4 [CRP]) at Week 4|DAS28-4 (CRP) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein (CRP) level, and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity.|Week 4|Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point.||units on a scale||Standard Deviation|Mean
824511|NCT01175018|Secondary|Difference Between the 2 Arm in the Interval Change in Right Ventricular Ejection Fraction (RVEF)||10-14 weeks|||% (absolute change)||Inter-Quartile Range|Median
822376|NCT01155570|Primary|Disease Activity Score 28-4, Erythrocyte Sedimentation Rate (DAS28-4 [ESR]) at Week 24|DAS28-4 (ESR) is calculated using the number of tender and swollen joints (out of 28 counted), erythrocyte sedimentation rate (ESR), and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity.|Week 24|Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point.||units on a scale||Standard Deviation|Mean
822377|NCT01155570|Primary|Disease Activity Score 28-4, Erythrocyte Sedimentation Rate (DAS28-4 [ESR]) at Week 16|DAS28-4 (ESR) is calculated using the number of tender and swollen joints (out of 28 counted), erythrocyte sedimentation rate (ESR), and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity.|Week 16|Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point.||units on a scale||Standard Deviation|Mean
822378|NCT01155570|Primary|Disease Activity Score 28-4, Erythrocyte Sedimentation Rate (DAS28-4 [ESR]) at Week 4|DAS28-4 (ESR) is calculated using the number of tender and swollen joints (out of 28 counted), erythrocyte sedimentation rate (ESR), and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity.|Week 4|Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point.||units on a scale||Standard Deviation|Mean
822379|NCT01155570|Primary|Pain Visual Analog Scale (VAS) at Week 24|Participants assessed their pain due to psoriatic arthritis in the past week, on a single-line Visual Analog Scale (VAS) from 0 (no pain) to 100 (pain as bad as it could be).|Week 24|Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point.||units on a scale||Standard Deviation|Mean
822380|NCT01155570|Secondary|Physician’s Overall Response Rating At Week 24|"Overall response rating, according to investigator’s subjective clinical opinion. The level of overall improvement rating was categorized as “markedly improved,” “improved,” “not changed,” or not assessable, comparing clinical conditions at Week 24 or at discontinuation with Baseline conditions."|Baseline and Week 24|Participants in the Efficacy Analysis Population with assessment at Week 24.||participants|||Number
822381|NCT01155570|Primary|Pain Visual Analog Scale (VAS) at Week 16|Participants assessed their pain due to psoriatic arthritis in the past week, on a single-line Visual Analog Scale (VAS) from 0 (no pain) to 100 (pain as bad as it could be).|Week 16|Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point.||units on a scale||Standard Deviation|Mean
822382|NCT01155570|Primary|Pain Visual Analog Scale (VAS) at Week 4|Participants assessed their pain due to psoriatic arthritis in the past week, on a single-line Visual Analog Scale (VAS) from 0 (no pain) to 100 (pain as bad as it could be).|Week 4|Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point.||units on a scale||Standard Deviation|Mean
822383|NCT01155570|Primary|Dermatology Life Quality Index at Week 24|Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot (score of 2), a little (score of 1), or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired.|Week 24|Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.||units on a scale||Standard Deviation|Mean
822384|NCT01155570|Primary|Dermatology Life Quality Index at Week 16|Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot (score of 2), a little (score of 1), or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired.|Week 16|Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.||units on a scale||Standard Deviation|Mean
822385|NCT01155570|Primary|Percentage of Participants With Psoriasis Area and Severity Index 90 (PASI90) Response at Week 24|PASI90 is defined as at least a 90% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0 (best) to 72 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 24 PASI score) divided by Week 0 PASI score.|Baseline and Week 24|Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.||percentage of participants|||Number
822386|NCT01155570|Primary|Percentage of Participants With Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16|PASI90 is defined as at least a 90% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0 (best) to 72 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 16 PASI score) divided by Week 0 PASI score.|Baseline and Week 16|Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.||percentage of participants|||Number
822387|NCT01155570|Primary|Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Week 24|PASI75 is defined as at least a 75% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0 (best) to 72 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 24 PASI score) divided by Week 0 PASI score.|Baseline and Week 24|Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.||percentage of participants|||Number
824512|NCT01175018|Secondary|Number of Adverse Events in Each Group||10-14 weeks|||adverse events|||Number
822391|NCT01155570|Primary|Physician's Global Assessment at Week 24|"The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories:
0 / Clear (plaque elevation=none, scaling=none, erythema=hyperpigmentation, pigmented macules, diffuse faint pink or red coloration);
1 / Minimal (plaque elevation=possible but difficult to ascertain whether there is a slight elevation above normal skin, scaling=surface dryness with some white coloration, erythema=up to moderate);
2 / Mild (plaque elevation=slight, scaling=fine, erythema=up to moderate);
3 / Moderate (plaque elevation=moderate, scaling=coarser, erythema=moderate);
4 / Severe (plaque elevation=marked, scaling=coarse, erythema=severe);
5 / Very Severe (plaque elevation=very marked, scaling=very coarse, erythema=very severe)."|Week 24|Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.||units on a scale||Standard Deviation|Mean
822392|NCT01155570|Primary|Physician's Global Assessment at Week 16|"The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories:
0 / Clear (plaque elevation=none, scaling=none, erythema=hyperpigmentation, pigmented macules, diffuse faint pink or red coloration);
1 / Minimal (plaque elevation=possible but difficult to ascertain whether there is a slight elevation above normal skin, scaling=surface dryness with some white coloration, erythema=up to moderate);
2 / Mild (plaque elevation=slight, scaling=fine, erythema=up to moderate);
3 / Moderate (plaque elevation=moderate, scaling=coarser, erythema=moderate);
4 / Severe (plaque elevation=marked, scaling=coarse, erythema=severe);
5 / Very Severe (plaque elevation=very marked, scaling=very coarse, erythema=very severe)."|Week 16|Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.||units on a scale||Standard Deviation|Mean
822393|NCT01155570|Primary|Physician's Global Assessment At Week 8|"The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories:
0 / Clear (plaque elevation=none, scaling=none, erythema=hyperpigmentation, pigmented macules, diffuse faint pink or red coloration);
1 / Minimal (plaque elevation=possible but difficult to ascertain whether there is a slight elevation above normal skin, scaling=surface dryness with some white coloration, erythema=up to moderate);
2 / Mild (plaque elevation=slight, scaling=fine, erythema=up to moderate);
3 / Moderate (plaque elevation=moderate, scaling=coarser, erythema=moderate);
4 / Severe (plaque elevation=marked, scaling=coarse, erythema=severe);
5 / Very Severe (plaque elevation=very marked, scaling=very coarse, erythema=very severe)."|Week 8|Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.||units on a scale||Standard Deviation|Mean
822394|NCT01155570|Primary|Physician's Global Assessment at Week 4|"The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories:
0 / Clear (plaque elevation=none, scaling=none, erythema=hyperpigmentation, pigmented macules, diffuse faint pink or red coloration);
1 / Minimal (plaque elevation=possible but difficult to ascertain whether there is a slight elevation above normal skin, scaling=surface dryness with some white coloration, erythema=up to moderate);
2 / Mild (plaque elevation=slight, scaling=fine, erythema=up to moderate);
3 / Moderate (plaque elevation=moderate, scaling=coarser, erythema=moderate);
4 / Severe (plaque elevation=marked, scaling=coarse, erythema=severe);
5 / Very Severe (plaque elevation=very marked, scaling=very coarse, erythema=very severe)."|Week 4|Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.||units on a scale||Standard Deviation|Mean
822395|NCT01155570|Primary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs), Serious Adverse Drug Reactions (SADRs), Deaths, and Discontinuations Due to AEs|This study was mandated by the Japanese government as an approval condition for Humira in Japan; therefore, definitions of adverse events and seriousness criteria were applicable as specified in the Japanese local standard operating procedures, based on local Japanese regulations. ADRs were defined as adverse events for which the causal relationship with Humira was other than “not related” (ie, “probable,” “possible,” or “unclear”). The count of participants with AEs presented in this table includes serious and nonserious AEs. The count of participants with discontinuations due to AEs includes those who discontinued due to an AE plus other reasons. Please see Safety section for further details regarding adverse events.|From study registration through Week 24|Safety Analysis Population||participants|||Number
822396|NCT01162863|Secondary|Change in Motility Pattern of the Small Bowel and Colon From Baseline as Defined by the Motility Index|Change in the motility index defined as the natural log [(sum of pressure amplitudes times the number of contractions) + 1] for the small bowel and colon based on a measurement done at baseline and then again at 3 weeks into the intervention.|21-28 days|||units on a scale||Standard Deviation|Mean
822397|NCT01162863|Secondary|Change in Small Bowel pH and Colon pH From Baseline|Change in the mean pH of the small intestine and colon based on a measurement done at baseline and then again at 3 weeks into the intervention.|21-28 days|||pH||Standard Deviation|Mean
822398|NCT01162863|Primary|Change in Gastric Emptying Time, Small Bowel Transit Time, Colon Transit Time and Whole Gut Transit Time From Baseline|Change in gastric emptying time, small bowel transit time, colon transit time and whole gut transit time measured in hours based on a measurement done at baseline and then again at 3 weeks into the intervention within each treatment arm|21-28 days|||hours||Standard Deviation|Mean
822399|NCT01163032|Secondary|Number of Patients With a Treatment Emergent Adverse Event (Open Label Extension Phase Only)|Adverse events were recorded in the source documents from the time of the patient’s informed consent signature until the end of the patient’s study participation. An AE was defined as any untoward medical occurrence in a clinical investigation patient who does not necessarily have causal relationship with treatment.|6 months|One subject who rolled into the OLE from the randomized phase (tasimelteon) experienced an unrelated TEAE during the OLE phase.||participants|||Number
822430|NCT01163097|Primary|Ratio to Baseline of Lipase.|Ratio to baseline lipase at Day 5 was calculated as Day 5 lipase divided by baseline lipase.|Day 5|The safety population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) or who had a set zero point (Treatment C). This outcome was assessed for Treatment A and B only as per study plan.||ratio||95% Confidence Interval|Geometric Mean
822400|NCT01163032|Other Pre-specified|Proportion of Patients With a Clinical Response (Score of ≥ 2 on N24CRS)|"Non-24 Clinical Response Scale (N24CRS) was a 4-item scale which includes LQ-nTST, UQ-dTSD, MoST and CGI-C assessments. Each assessment is scored as a 1 or 0 depending on the pre-specified threshold (see below).
LQ-nTST: >45 minutes increase in average nighttime sleep duration; UQ-dTSD: >45 minutes decrease in average daytime sleep duration; MoST: >30 minutes increase and a standard deviation <2 hours during double-masked phase (6 months); CGI-C: <2.0 from the average of D112 and Day 183 compared to baseline"|6 months|Analysis Population: all patients in the ITT population that had at least 70% of 1 circadian cycle of nighttime total sleep data reported during each phase (screening and post-randomization)||percentage of patients|||Number
822401|NCT01163032|Post-Hoc|Proportion of Responders With a Combined Sleep/Wake Response for LQ-nTST (≥ 45 Minutes) and UQ-dTSD (≤ 45 Minutes)|Responder analysis with responder defined as an increase of 45 minutes or more in (LQ-nTST) and a decrease of 45 minutes or more in (UQ-dTSD).|6 months|Analysis Population: all patients in the ITT population that had at least 70% of 1 circadian cycle of nighttime total sleep data reported during each phase (screening and post-randomization)||percentage of patients|||Number
822402|NCT01163032|Secondary|Average Midpoint of Sleep (MoST)|Midpoint of Sleep Timing (MoST) is the measurement of the average midpoint of sleep time relative to bedtime. The average MoST value will trend to 0 as an individual's sleep becomes more fragmented. Improvement is defined as an increase in the average.|6 months|Analysis Population: all patients in the ITT population that had at least 70% of 1 circadian cycle of nighttime total sleep data reported during each phase (screening and post-randomization)||minutes||Standard Error|Mean
822403|NCT01163032|Secondary|Average Upper Quartile of Days of Subjective Daytime Sleep Duration (UQ-dTSD)|UQ-dTSD measures the difference in average daytime sleep during the patient's worst 25% of days (longest total daytime sleep) between the randomized phase (6 months) and the screening phase (~ 6 weeks). Lower number indicates improvement.|6 months|Analysis Population: all patients in the ITT population that had at least 70% of 1 circadian cycle of nighttime total sleep data reported during each phase (screening and post-randomization)||minutes||Standard Error|Mean
822404|NCT01163032|Secondary|Average Lower Quartile of Nights of Nighttime Total Sleep Time (LQ-nTST)|LQ-nTST measures the difference in average nighttime sleep during the patient's worst 25% of nights (shortest total nighttime sleep) between the randomized phase (6 months)and the screening phase (~ 6 weeks). The higher number indicates improvement.|6 months|Analysis Population: all patients in the ITT population that had at least 70% of 1 circadian cycle of nighttime total sleep data reported during each phase (screening and post-randomization)||minutes||Standard Error|Mean
822405|NCT01163032|Secondary|Proportion of Responders With a Combined Sleep/Wake Response for LQ-nTST (≥ 90 Minutes) and UQ-dTSD (≤ 90 Minutes)|The sleep/wake response represents measurement of the combined improvement in the nighttime sleep duration and daytime sleep duration. Individuals that have an improvement in nighttime sleep and daytime sleep, defined as an increase of 90 minutes or more in the lower quartile of subjective nighttime total sleep time (LQ-nTST) and a decrease of 90 minutes or more in the upper quartile of daytime total sleep duration (UQ-dTSD) are considered to be a responder.|6 months|Analysis Population: all patients in the ITT population that had at least 70% of 1 circadian cycle of nighttime total sleep data reported during each phase (screening and post-randomization)||percentage of patients|||Number
822406|NCT01163032|Secondary|Average Clinical Global Impression of Change (CGI-C)|CGI-C scores range from 1 (very much improved) to 7 (very much worse). The average post-randomization score was obtained for each patient by averaging the last 2 scheduled assessments (Day D112 and Day D183). Lower number indicates improvement.|Day 112 and 183|Analysis Population: all patients in the ITT population that had at least 70% of 1 circadian cycle of nighttime total sleep data reported during each phase (screening and post-randomization)||score||Standard Error|Mean
822407|NCT01163032|Secondary|Proportion of Patients Entrained as Assessed by Urinary Cortisol|Entrainment is a measure of synchronization of the master body clock to the 24-hour day. The circadian period (τ) was calculated using urinary cortisol collected over four 48 hour periods, approximately 1 week apart for 4 separate weeks, during the screening and month 1 of the randomization phase of the trial. Entrainment was defined as having a post-baseline τ value less than 24.1 and a 95% CI that included 24.0.|1 month|Intent-to-Treat (ITT) Population: all subjects randomized into the study that have τ calculated post-randomization.||percentage of patients|||Number
822408|NCT01163032|Other Pre-specified|Proportion of Patients With a Clinical Response (Score of ≥ 3 on N24CRS)|"Non-24 Clinical Response Scale (N24CRS) was a 4-item scale which includes LQ-nTST, UQ-dTSD, MoST and CGI-C assessments. Each assessment is scored as a 1 or 0 depending on the pre-specified threshold (see below).
LQ-nTST: >45 minutes increase in average nighttime sleep duration; UQ-dTSD: >45 minutes decrease in average daytime sleep duration; MoST: >30 minutes increase and a standard deviation <2 hours during double-masked phase (6 months); CGI-C: <2.0 from the average of D112 and Day 183 compared to baseline"|6 months|Analysis Population: all patients in the ITT population that had at least 70% of 1 circadian cycle of nighttime total sleep data reported during each phase (screening and post-randomization)||percentage of patients|||Number
822409|NCT01163032|Other Pre-specified|Proportion of Patients With a Clinical Response: Entrainment of aMT6 and Score of ≥ 2 on N24CRS|"Clinical response is defined as the coincident demonstration of entrainment (aMT6) and a score ≥ 2 on the Non-24 Clinical Response Scale (N24CRS) which includes LQ-nTST, UQ-dTSD, MoST and CGI-C assessments. Each assessment is scored as a 1 or 0 depending on the pre-specified threshold (see below).
LQ-nTST: >45 minutes increase in average nighttime sleep duration; UQ-dTSD: >45 minutes decrease in average daytime sleep duration; MoST: >30 minutes increase and a standard deviation <2 hours during double-masked phase (6 months); CGI-C: <2.0 from the average of D112 and Day 183 compared to baseline
For patients randomized to tasimelteon 20 mg and who also participated in the screening phase of Study 3203 (month 7 of treatment), the screening τ from Study 3203 was used if the patient did not become entrained in Study 3201 but did become entrained during the screening phase of Study 3203."|6 months|Analysis Population: all patients in the ITT population that had at least 70% of 1 circadian cycle of nighttime total sleep data reported during each phase (screening and post-randomization)||percentage of patients|||Number
822431|NCT01163097|Primary|Ratio to Baseline of Amylase|Ratio to baseline amylase at Day 5 was calculated as Day 5 amylase divided by baseline amylase.|Day 5|The safety population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) or who had a set zero point (Treatment C). This outcome was assessed for Treatment A and B only as per study plan.||ratio||95% Confidence Interval|Geometric Mean
822410|NCT01163032|Primary|Proportion of Patients With a Clinical Response: Entrainment of aMT6 and Score of ≥ 3 on N24CRS|"Clinical response is defined as the coincident demonstration of entrainment (aMT6) and a score ≥ 3 on the Non-24 Clinical Response Scale (N24CRS). N24CRS measures improvement in sleep-wake measures and overall functioning (LQ-nTST, UQ-dTSD, MoST and CGI-C). Each assessment is scored as a 1 or 0 depending on the pre-specified threshold (see below).
LQ-nTST: >45 minutes increase in average nighttime sleep duration; UQ-dTSD: >45 minutes decrease in average daytime sleep duration; MoST: >30 minutes increase and a standard deviation <2 hours during double-masked phase (6 months); CGI-C: <2.0 from the average of D112 and Day 183 compared to baseline
For patients randomized to tasimelteon 20 mg and who also participated in the screening phase of Study 3203 (month 7 of treatment), the screening τ from Study 3203 was used if the patient did not become entrained in Study 3201 but did become entrained during the screening phase of Study 3203."|6 months|Analysis Population: all patients in the ITT population that had at least 70% of 1 circadian cycle of nighttime total sleep data reported during each phase (screening and post-randomization)||percentage of patients|||Number
822411|NCT01163032|Primary|Proportion of Patients Entrained as Assessed by Urinary aMT6|Entrainment is a measure of synchronization of the master body clock to the 24-hour day. The circadian period (τ) was calculated using urinary aMT6s collected over four 48 hour periods , collected approximately 1 week apart for 4 separate weeks, during the screening and month 1 of the randomization phase of the trial. Entrainment was defined as having a post-baseline τ value less than 24.1 and a 95% CI that included 24.0.|1 month|Intent-to-Treat (ITT) Population: all subjects randomized into the study that have τ calculated post-randomization.||percentage of patients|||Number
822412|NCT01163097|Secondary|Ratio to Baseline of Albumin/Creatinine|"The albumin/creatinine ratio is the urinary albumin (mg) divided by the urinary creatinine (g) result at the specified time point.
Ratio to baseline was calculated as albumin/creatinine ratio at specified day divided by baseline albumin/creatinine ratio."|Day 4|The safety population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) or who had a set zero point (Treatment C). This outcome was assessed for Treatment B and C only as per study plan.||ratio||Standard Deviation|Mean
822413|NCT01163097|Secondary|Ratio to Baseline of Albumin/Creatinine|"The albumin/creatinine ratio is the urinary albumin (mg) divided by the urinary creatinine (g) result at the specified time point.
Ratio to baseline was calculated as albumin/creatinine ratio at specified day divided by baseline albumin/creatinine ratio."|Day 3|The safety population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) or who had a set zero point (Treatment C). This outcome was assessed for Treatment B and C only as per study plan.||ratio||Standard Deviation|Mean
822414|NCT01163097|Secondary|Ratio to Baseline of Albumin/Creatinine|"The albumin/creatinine ratio is the urinary albumin (mg) divided by the urinary creatinine (g) result at the specified time point.
Ratio to baseline was calculated as albumin/creatinine ratio at specified day divided by baseline albumin/creatinine ratio."|Day 2|The safety population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) or who had a set zero point (Treatment C). This outcome was assessed for Treatment B and C only as per study plan.||ratio||Standard Deviation|Mean
822415|NCT01163097|Secondary|Ratio to Baseline of Albumin/Creatinine|"The albumin/creatinine ratio is the urinary albumin (mg) divided by the urinary creatinine (g) result at the specified time point.
Ratio to baseline was calculated as albumin/creatinine ratio at specified day divided by baseline albumin/creatinine ratio."|Day 1|The safety population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) or who had a set zero point (Treatment C). This outcome was assessed for Treatment B and C only as per study plan.||ratio||Standard Deviation|Mean
822416|NCT01163097|Secondary|Ratio to Baseline of Protein/Creatinine|"Protein/creatinine ratio is the urinary protein (mg) divided by the urinary creatinine (g) result.
Ratio to baseline protein/creatinine ratio was calculated as protein/creatinine ratio at specified day divided by baseline protein/creatinine ratio."|Day 3|The safety population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) or who had a set zero point (Treatment C). This outcome was assessed for Treatment B and C only as per study plan.||ratio||Standard Deviation|Mean
822417|NCT01163097|Secondary|Ratio to Baseline of Protein/Creatinine|"Protein/creatinine ratio is the urinary protein (mg) divided by the urinary creatinine (g) result.
Ratio to baseline protein/creatinine ratio was calculated as protein/creatinine ratio at specified day divided by baseline protein/creatinine ratio."|Day 2|The safety population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) or who had a set zero point (Treatment C). This outcome was assessed for Treatment B and C only as per study plan.||ratio||Standard Deviation|Mean
822418|NCT01163097|Secondary|Ratio to Baseline of Protein/Creatinine|"Protein/creatinine ratio is the urinary protein (mg) divided by the urinary creatinine (g) result.
Ratio to baseline protein/creatinine ratio was calculated as protein/creatinine ratio at specified day divided by baseline protein/creatinine ratio."|Day 1|The safety population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) or who had a set zero point (Treatment C). This outcome was assessed for Treatment B and C only as per study plan.||ratio||Standard Deviation|Mean
822419|NCT01163097|Secondary|Subject Incidence of Proteinuria|"Protein/creatinine ratio is the urinary protein (mg) divided by the urinary creatinine (g) result at the specified time point.
Incidence of proteinuria defined as urinary protein/creatinine ratio exceeding 200 mg/g was calculated at Day 4 and overall at any time point. Incidence was calculated by treatment as number of subjects with proteinuria divided by the total number of subjects."|Day 4|The safety population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) or who had a set zero point (Treatment C). This outcome was assessed for Treatment B and C only as per study plan.||participants|||Number
822420|NCT01163097|Secondary|Subject Incidence of Treatment-emergent Adverse Event|Adverse events (AE) was considered treatment emergent if the AE started after the time of heparin titration (Treatment A), palifermin dosing on Day 1 (Treatment B), or set zero point (Treatment C).|Day 45|The safety population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) or who had a set zero point (Treatment C)||participants|||Number
822849|NCT01158924|Primary|Treatment Emergent Adverse Events- Relationship to Study Drug|Number of patients with Treatment Emergent Adverse Events that were designated as related or possibly related to Study Drug.|Through a 12 month period and annual telephone contact at 24 and 36 months for subject health status follow-up.|Safety Population||participants|||Number
822421|NCT01163097|Secondary|Palifermin PK Parameters: Vss|"Blood samples for palifermin PK was collected pre-dose on Days 1 and 3 of the treatment period; 2, 5, 15 and 30 minutes; and 1, 2, 4, 6, 12, 18 and 24 hours after the Day 1 and Day 3 dose of palifermin (Treatment A and Treatment B only).
Descriptive pharmacokinetic parameters for palifermin Vss was determined by linear/log trapezoidal method. Parameters was calculated from individual subject serum concentration-time data using actual subject blood collection times. Serum concentrations reported below the lower limit of quantification (LLOQ) was treated as zero."|Day 3|The pharmacokinetics population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) and at least one post dose PK serum sample||mL/Kg||Geometric Coefficient of Variation|Geometric Mean
822422|NCT01163097|Secondary|Palifermin PK Parameters: Apparent Volume of Distribution at Steady State (Vss)|"Blood samples for palifermin PK was collected pre-dose on Days 1 and 3 of the treatment period; 2, 5, 15 and 30 minutes; and 1, 2, 4, 6, 12, 18 and 24 hours after the Day 1 and Day 3 dose of palifermin (Treatment A and Treatment B only).
Descriptive pharmacokinetic parameters for palifermin Vss was determined by linear/log trapezoidal method. Parameters was calculated from individual subject serum concentration-time data using actual subject blood collection times. Serum concentrations reported below the lower limit of quantification (LLOQ) was treated as zero."|Day 1|The pharmacokinetics population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) and at least one post dose PK serum sample||mL/kg||Geometric Coefficient of Variation|Geometric Mean
822423|NCT01163097|Secondary|Palifermin PK Parameters: C0|"Blood samples for palifermin PK was collected pre-dose on Days 1 and 3 of the treatment period; 2, 5, 15 and 30 minutes; and 1, 2, 4, 6, 12, 18 and 24 hours after the Day 1 and Day 3 dose of palifermin.
Descriptive pharmacokinetic parameters for palifermin C0 was determined by linear/log trapezoidal method. Parameters was calculated from individual subject serum concentration-time data using actual subject blood collection times. Serum concentrations reported below the lower limit of quantification (LLOQ) was treated as zero."|Day 3|The pharmacokinetics population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) and at least one post dose PK serum sample||ng/mL||Geometric Coefficient of Variation|Geometric Mean
822424|NCT01163097|Secondary|Palifermin PK Parameters: Estimated Concentration at Time 0 (C0)|"Blood samples for palifermin PK was collected pre-dose on Days 1 and 3 of the treatment period; 2, 5, 15 and 30 minutes; and 1, 2, 4, 6, 12, 18 and 24 hours after the Day 1 and Day 3 dose of palifermin.
Descriptive pharmacokinetic parameters for palifermin C0 was determined by linear/log trapezoidal method. Parameters was calculated from individual subject serum concentration-time data using actual subject blood collection times. Serum concentrations reported below the lower limit of quantification (LLOQ) was treated as zero."|Day 1|The pharmacokinetics population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) and at least one post dose PK serum sample||ng/mL||Geometric Coefficient of Variation|Geometric Mean
822425|NCT01163097|Secondary|Palifermin PK Parameters: AUC (0-24)|"Blood samples for palifermin PK was collected pre-dose on Days 1 and 3 of the treatment period; 2, 5, 15 and 30 minutes; and 1, 2, 4, 6, 12, 18 and 24 hours after the Day 1 and Day 3 dose of palifermin.
Descriptive pharmacokinetic parameters for palifermin AUC(0-24) was determined by linear/log trapezoidal method. Parameters was calculated from individual subject serum concentration-time data using actual subject blood collection times. Serum concentrations reported below the lower limit of quantification (LLOQ) was deleted from calculation."|Day 3|The pharmacokinetics population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) and at least one post dose PK serum sample||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
822426|NCT01163097|Secondary|Palifermin PK Parameters: Area Under the Serum Curve (AUC) (0-24)|"Blood samples for palifermin PK was collected pre-dose on Days 1 and 3 of the treatment period; 2, 5, 15 and 30 minutes; and 1, 2, 4, 6, 12, 18 and 24 hours after the Day 1 and Day 3 dose of palifermin.
Descriptive pharmacokinetic parameters for palifermin AUC(0-24) was determined by linear/log trapezoidal method. Parameters was calculated from individual subject serum concentration-time data using actual subject blood collection times. Serum concentrations reported below the lower limit of quantification (LLOQ) was deleted from calculation."|Day 1|The pharmacokinetics population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) and at least one post dose PK serum sample||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
822427|NCT01163097|Secondary|Palifermin PK Parameters: CL|"Blood samples for palifermin PK was collected pre-dose on Days 1 and 3 of the treatment period; 2, 5, 15 and 30 minutes; and 1, 2, 4, 6, 12, 18 and 24 hours after the Day 1 and Day 3 dose of palifermin.
Descriptive PK parameters for palifermin CL for subjects assigned to Treatment A and Treatment B was determined by linear/log trapezoidal method. Parameters was calculated from individual subject serum concentration-time data using actual subject blood collection times. Serum concentrations reported below the lower limit of quantification (LLOQ) was treated as zero."|Day 3|The pharmacokinetics population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) and at least one post dose PK serum sample||(mL/hr/kg)||Geometric Coefficient of Variation|Geometric Mean
822428|NCT01163097|Secondary|Palifermin Pharmacokinetic (PK) Parameters: Clearance (CL)|"Blood samples for palifermin PK was collected pre-dose on Days 1 and 3 of the treatment period; 2, 5, 15 and 30 minutes; and 1, 2, 4, 6, 12, 18 and 24 hours after the Day 1 and Day 3 dose of palifermin.
Descriptive PK parameters for palifermin CL for subjects assigned to Treatment A and Treatment B was determined by linear/log trapezoidal method. Parameters was calculated from individual subject serum concentration-time data using actual subject blood collection times. Serum concentrations reported below the lower limit of quantification (LLOQ) was treated as zero."|Day 1|The pharmacokinetics (PK) population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) and at least one post dose PK serum sample||(mL/hr/kg)||Geometric Coefficient of Variation|Geometric Mean
822429|NCT01163097|Primary|Ratio to Baseline of Protein/Creatinine|"Protein/creatinine ratio is the urinary protein (mg) divided by the urinary creatinine (g) result.
Ratio to baseline protein/creatinine ratio was calculated as protein/creatinine ratio at specified day divided by baseline protein/creatinine ratio."|Day 4|The safety population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) or who had a set zero point (Treatment C). This outcome was assessed for Treatment B and C only as per study plan.||ratio||95% Confidence Interval|Geometric Mean
822432|NCT01163097|Primary|Incidence of Grade 2 or Higher Specific Skin-related Adverse Events.|"Incidence of grade 2 or higher specific skin-related treatment emergent adverse events following palifermin administration was calculated for subjects in treatment groups A and B. Incidence was calculated by treatment as number of subjects with grade 2 or higher specific skin-related AEs divided by the total number of subjects.
The Common Terminology Criteria for Adverse Events (CTCAE v3.0) for Dermatology/Skin was used to determine the toxicity grade for a skin-related adverse event. (http://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/ctcaev3.pdf)"|Day 45|The safety population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B), or who had a set zero point (Treatment C). This outcome was assessed for Treatment A and B only as per study plan.||proportion of participants|||Number
822433|NCT01163097|Primary|Ratio to Baseline of Epithelial Cell Proliferation as Assessed by Ki67 Staining of Buccal Mucosal Tissue.|This outcome is a measure of the palifermin effect on the buccal mucosal cells. Ki67 is a measure of proliferation of cells in the buccal mucosa. This measure assess the number of cells per millimeter (mm) before and after palifermin treatment.|Day 4|The pharmacodynamic population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B), or who had a set zero point (Treatment C) and had both baseline and Day 4 buccal biopsy samples collected. This analysis was only performed for Treatment A relative to Treatment B as per study plan.||ratio||90% Confidence Interval|Geometric Mean
822434|NCT01163253|Secondary|Number of Participants Who Answered Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU)|Ps-HCRU was a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. In the first section, it assessed direct costs associated with healthcare resource use which included participant’s interactions with healthcare providers such as general practitioners, dermatologists, cardiologists, gastroenterologists, psychiatrists, surgeons and nurses. When taking the evening dose of tofacitinib, participants were asked to answer the Ps-HCRU questionnaire only if they had an interaction with a healthcare provider or their work was impacted by psoriasis on that specified day. In this outcome measure, number of participants who answered Ps-HCRU at any specified visits were reported.|Baseline, Month 1, 3, 6, 12, 24, 36, 48|Safety analysis set included all participants who received at least 1 dose of study drug.||participants|||Number
822435|NCT01163253|Secondary|Euro Quality of Life-5-Dimensions (EQ-5D)-Visual Analogue Scale Scores (VAS)|EQ-5D VAS was a participant rated questionnaire to assess health-related quality of life in terms of a single index value. It was a visual analogue scale that ranged from 0 (minimum) to 100 (maximum), with higher scores indicating a better health condition.|Baseline, Month 6, 12, 24, 36, 48|FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||units on a scale||Standard Deviation|Mean
822436|NCT01163253|Secondary|Euro Quality of Life- 5-Dimensions (EQ-5D)-Utility Scores|EQ-5D: participant rated 5-dimension (mobility, self-care, usual activities, pain and discomfort, and anxiety and depression) questionnaire to assess health-related quality of life in terms of a single utility score. Each dimension was assessed on a 3-point scale (1=no problems, 2=some problems, 3=extreme problems, where higher scores=worse health condition). The responses from the 5 dimensions were used to calculate a single utility index value. Scoring formula developed by EuroQol Group assigned a utility value for each dimension in the profile. Score was transformed and results in a total score range -0.594 to 1.000; higher score indicated a better health state.|Baseline, Month 6, 12, 24, 36, 48|FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||units on a scale||Standard Deviation|Mean
822437|NCT01163253|Secondary|Number of Participants With Patient Global Assessment (PtGA) Response of “Clear” or “Almost Clear”|The PtGA evaluated the overall skin disease of participants at that point in time on a single-item. Participants provided their response on a 5-point scale ranges from: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe. Higher score indicated greater severity of disease. Participants who provided their response as “clear (score of 0)” or “almost clear (score of 1)” in PtGA at each specified visit were reported in this outcome measure.|Baseline, Month 1, 3, 6, 12, 24, 36, 48|FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||participants|||Number
822438|NCT01163253|Secondary|36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Mental Component Summary Scores|The SF-36 questionnaire, version 2 was a 36-item generic health status measure. SF-36 evaluated 8 health-related aspects of an individual: physical functioning, role-physical, bodily pain, social functioning, mental health, role emotional, vitality, and general health. The score range for each of the 8 health aspects ranged from 0 (worst) to 100 (best), with higher scores indicating good health condition. Two summary scale scores were computed from the 8 health aspect scores: the Physical Component Summary and the Mental Component Summary. Score range for both summary scale ranged from 0 (worst) to 100 (best), with higher scores indicating good health condition.|Baseline, Month 6, 12, 24, 36, 48|FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||units on a scale||Standard Deviation|Mean
822461|NCT01163253|Primary|Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 24||Baseline, Month 24|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||msec||Standard Deviation|Mean
822880|NCT01159262|Secondary|Percentage of Subjects Who Received Rescue Medication for Analgesia During Dexmedetomidine Infusion||During Study drug administration (6 to 24 hours)|Efficacy Evaluable Population: All subjects who received randomized Dexmedetomidine for at least 6 hours.||percentage of subjects|||Number
822439|NCT01163253|Secondary|36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Physical Component Summary Scores|The SF-36 questionnaire, version 2, acute was a 36-item generic health status measure. SF-36 evaluated 8 health-related aspects of an individual: physical functioning, role-physical, bodily pain, social functioning, mental health, role emotional, vitality, and general health. The score range for each of the 8 health aspects ranged from 0 (worst) to 100 (best), with higher scores indicating good health condition. Two summary scale scores were computed from the 8 health aspect scores: physical component summary score and mental component summary score. Score range for both summary scales ranged from 0 (worst) to 100 (best), with higher scores indicating good health condition.|Baseline, Month 6, 12, 24, 36, 48|FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||units on a scale||Standard Deviation|Mean
822440|NCT01163253|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Scores at Month 1, 6, 12, 24, 36 and 48|The DLQI was a validated, self-administered, 10-item quality-of-life questionnaire that consisted of 10 items that assessed the impact of skin disease on quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). Each question was scored on a scale of 0=not at all/not relevant to 3=very much. Response from all of the 10 questions were added to derive the DLQI total scores. Total DLQI scores ranges from 0=not at all to 30=very much, with higher scores indicating greater impairment in quality of life.|Baseline, Month 1, 6, 12, 24, 36, 48|FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||units on a scale||Standard Deviation|Mean
822441|NCT01163253|Secondary|Dermatology Life Quality Index (DLQI) Scores|The DLQI was a validated, self-administered, 10-item quality-of-life questionnaire that consisted of 10 items that assessed the impact of skin disease on quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). Each question was scored on a scale of 0=not at all/not relevant to 3=very much. Response from all of the 10 questions were added to derive the DLQI total scores. Total DLQI scores ranges from 0=not at all to 30=very much, with higher scores indicating greater impairment in quality of life.|Baseline, Month 1, 6, 12, 24, 36, 48|FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||units on a scale||Standard Deviation|Mean
822442|NCT01163253|Secondary|Change From Baseline in Itch Severity Item (ISI) Scores at Month 1, 3, 6, 12, 24, 36 and 48|ISI assessed severity of itching due to psoriasis. ISI was a single item, horizontal numeric rating scale. Participants were asked to rate their 'severity of itching' due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms '0=no itching' and '10=worst possible itching' at the ends. Higher scores indicated greater severity of itching.|Baseline, Month 1, 3, 6, 12, 24, 36, 48|FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||units on a scale||Standard Deviation|Mean
822443|NCT01163253|Secondary|Itch Severity Item (ISI) Scores|ISI assessed severity of itching due to psoriasis. ISI was a single item, horizontal numeric rating scale. Participants were asked to rate their 'severity of itching' due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms '0=no itching' and '10=worst possible itching' at the ends. Higher scores indicated greater severity of itching.|Baseline, Month 1, 3, 6, 12, 24, 36, 48|FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||units on a scale||Standard Deviation|Mean
822444|NCT01163253|Secondary|Percentage of Participants Achieving Greater Than or Equal to (>=) 125 Percent Increase From Baseline in Psoriasis Area and Severity Index (PASI) Scores|PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck [h], upper limbs [u], trunk [t] and lower limbs [l]) on a 5-point scale ranging from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. Percentage of participants with >=125% increase from baseline in PASI scores were reported.|Baseline, Month 1, 3, 6, 12, 24, 36, 48|FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||percentage of participants||95% Confidence Interval|Number
822451|NCT01163253|Secondary|Psoriasis Area and Severity Index (PASI) Component Scores: Induration|PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Induration was assessed separately for four body areas (head and neck, upper limbs, trunk and lower limbs) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity.|Baseline, Month 1, 3, 6, 12, 24, 36, 48|FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||units on a scale||Standard Deviation|Mean
822445|NCT01163253|Secondary|Percentage of Participants Achieving Greater Than or Equal to (>=) 90 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores|PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck [h], upper limbs [u], trunk [t] and lower limbs [l]) on a 5-point scale ranging from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. Percentage of participants with >=90% reduction from baseline in PASI scores were reported.|Baseline, Month 1, 3, 6, 12, 24, 36, 48|FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||percentage of participants||95% Confidence Interval|Number
822446|NCT01163253|Secondary|Percentage of Participants Achieving Greater Than or Equal to (>=) 50 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores|PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck [h], upper limbs [u], trunk [t] and lower limbs [l]) on a 5-point scale ranging from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. Percentage of participants with >=50% reduction from baseline in PASI scores were reported.|Baseline, Month 1, 3, 6, 12, 24, 36, 48|FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||percentage of participants||95% Confidence Interval|Number
822447|NCT01163253|Secondary|Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48|PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Scaling was assessed separately for four body areas (head and neck, upper limbs, trunk and lower limbs) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity.|Baseline, Month 1, 3, 6, 12, 24, 36, 48|FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||units on a scale||Standard Deviation|Mean
822448|NCT01163253|Secondary|Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48|PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Induration was assessed separately for four body areas (head and neck, upper limbs, trunk and lower limbs) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity.|Baseline, Month 1, 3, 6, 12, 24, 36, 48|FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||units on a scale||Standard Deviation|Mean
822449|NCT01163253|Secondary|Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48|PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Erythema was assessed separately for four body areas (head and neck, upper limbs, trunk and lower limbs) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity.|Baseline, Month 1, 3, 6, 12, 24, 36, 48|FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||units on a scale||Standard Deviation|Mean
822450|NCT01163253|Secondary|Psoriasis Area and Severity Index (PASI) Component Scores: Scaling|PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Scaling was assessed separately for four body areas (head and neck, upper limbs, trunk and lower limbs) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity.|Baseline, Month 1, 3, 6, 12, 24, 36, 48|FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||units on a scale||Standard Deviation|Mean
822459|NCT01163253|Primary|Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 48||Baseline, Month 48|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||msec||Standard Deviation|Mean
822452|NCT01163253|Secondary|Psoriasis Area and Severity Index (PASI) Component Scores: Erythema|PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Erythema was assessed separately for four body areas (head and neck, upper limbs, trunk and lower limbs) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity.|Baseline, Month 1, 3, 6, 12, 24, 36, 48|FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||units on a scale||Standard Deviation|Mean
822453|NCT01163253|Secondary|Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Month 1, 3, 6, 12, 24, 36 and 48|PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck [h], upper limbs [u], trunk [t] and lower limbs [l]) on a 5-point scale ranging from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4.|Baseline, Month 1, 3, 6, 12, 24, 36, 48|FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||units on a scale||Standard Deviation|Mean
822454|NCT01163253|Secondary|Psoriasis Area and Severity Index (PASI) Scores|PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck [h], upper limbs [u], trunk [t] and lower limbs [l]) on a 5-point scale ranging from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4.|Baseline, Month 1, 3, 6, 12, 24, 36, 48|FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||units on a scale||Standard Deviation|Mean
822455|NCT01163253|Secondary|Percentage of Participants Achieving Greater Than or Equal to (>=) 75 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores|PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck [h], upper limbs [u], trunk [t] and lower limbs [l]) on a 5-point scale ranging from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. Percentage of participants with >=75 percent (%) reduction from baseline in PASI scores were reported.|Baseline, Month 1, 3, 6, 12, 24, 36, 48|FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||percentage of participants||95% Confidence Interval|Number
822456|NCT01163253|Secondary|Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear'|The PGA of psoriasis was scored on a 5-point scale, reflecting a global consideration of the erythema (E), induration (I), and scaling (S) across all psoriatic lesions in participants. The severity rating scores (Erythema: 0= no evidence of erythema to 4= dark, deep red; Induration: 0= no evidence of plaque elevation to 4= marked plaque elevation, hard/sharp borders; Scaling: 0= no evidence of scaling to 4= thick, coarse scale predominates) were summed (E + I + S = total) and the average (total/3) was taken. The total average was rounded to the nearest whole number score to determine the PGA. The 5-point scale for PGA was: 0= clear; 1= almost clear; 2= mild; 3= moderate; 4= severe, where higher score indicated more severity of psoriasis. Percentage of participants with response of 'clear' (score of '0') and 'almost clear' (score of '1') were reported.|Month 1, 3, 6, 12, 24, 36, 48|Full analysis set (FAS) included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies participants evaluable for this outcome measure and ‘n’ signifies participants who were evaluable at specified time points for each arm, respectively.||percentage of participants||95% Confidence Interval|Number
822457|NCT01163253|Primary|Number of Participants With Malignancy Events|Malignancy events included lymphoma, and demyelinating neurologic events. Biopsies collected for malignancy events were submitted to the central laboratory for pathologist over-read.|Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)|Safety analysis set included all participants who received at least 1 dose of study drug.||participants|||Number
822458|NCT01163253|Primary|Number of Participants With Adjudicated Cardiovascular Events|Adjudicated cardiovascular events were assessed by adjudication committee as independent reviewers based on event documentation including: hospital discharge summaries, operative reports, clinic notes, ECGs, diagnostic enzymes, results of other diagnostic tests, autopsy reports and death certificate information; as applicable.|Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)|Safety analysis set included all participants who received at least 1 dose of study drug.||participants|||Number
822462|NCT01163253|Primary|Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 12||Baseline, Month 12|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||msec||Standard Deviation|Mean
822463|NCT01163253|Primary|Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 6||Baseline, Month 6|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||milliseconds (msec)||Standard Deviation|Mean
822464|NCT01163253|Primary|Number of Participants With Electrocardiogram (ECG) Abnormalities|Criteria for ECG abnormality: PR interval >=300 milliseconds (msec); QT interval >=500 msec; QTcB (Bazett’s Correction) and QTcF (Fridericia’s Correction) 450 to <480 msec, 480 to <500 msec and >=500 msec.|Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)|Safety analysis set included all participants who received at least 1 dose of study drug.||participants|||Number
822465|NCT01163253|Primary|Change From Baseline in Heart Rate at Month 48||Baseline, Month 48|Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.||beats per minute||Standard Deviation|Mean
822466|NCT01163253|Primary|Change From Baseline in Heart Rate at Month 36||Baseline, Month 36|Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.||beats per minute||Standard Deviation|Mean
822467|NCT01163253|Primary|Change From Baseline in Heart Rate at Month 24||Baseline, Month 24|Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.||beats per minute||Standard Deviation|Mean
822468|NCT01163253|Primary|Change From Baseline in Heart Rate at Month 12||Baseline, Month 12|Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.||beats per minute||Standard Deviation|Mean
822469|NCT01163253|Primary|Change From Baseline in Heart Rate at Month 6||Baseline, Month 6|Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.||beats per minute||Standard Deviation|Mean
822470|NCT01163253|Primary|Change From Baseline in Heart Rate at Month 3||Baseline, Month 3|Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.||beats per minute||Standard Deviation|Mean
822471|NCT01163253|Primary|Change From Baseline in Heart Rate at Month 1||Baseline, Month 1|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||beats per minute||Standard Deviation|Mean
822472|NCT01163253|Primary|Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 48||Baseline, Month 48|Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.||mmHg||Standard Deviation|Mean
822473|NCT01163253|Primary|Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 36||Baseline, Month 36|Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.||mmHg||Standard Deviation|Mean
822474|NCT01163253|Primary|Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 24||Baseline, Month 24|Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.||mmHg||Standard Deviation|Mean
822475|NCT01163253|Primary|Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 12||Baseline, Month 12|Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.||mmHg||Standard Deviation|Mean
822476|NCT01163253|Primary|Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 6||Baseline, Month 6|Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.||mmHg||Standard Deviation|Mean
822477|NCT01163253|Primary|Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 3||Baseline, Month 3|Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.||mmHg||Standard Deviation|Mean
822478|NCT01163253|Primary|Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 1||Baseline, Month 1|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||millimeter of mercury (mmHg)||Standard Deviation|Mean
822479|NCT01163253|Primary|Number of Participants With Vital Sign Abnormalities|Criteria for abnormalities in vital signs included: Systolic blood pressure (SBP): less than (<) 90 millimeter of mercury (mmHg) and maximum increase from baseline (IFB) of greater than or equal to (>=) 30 mmHg; diastolic blood pressure (DBP): <50 and greater than (>) 120 mmHg and maximum IFB of >=20 mmHg; heart rate: <40 and >120 beats per minute.|Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||participants|||Number
822480|NCT01163253|Primary|Number of Participants With Clinically Significant Change From Baseline in Physical Examination|Physical examinations included: general appearance; skin, head, eyes, ears, nose and throat; heart; lungs; abdomen; lower extremities (for the presence of peripheral edema) and lymph nodes. Clinical significance of change from baseline values in physical examination was based on investigator's discretion.|Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)|Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.||participants|||Number
822481|NCT01163253|Primary|Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 48||Baseline, Month 48|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||IU/L||Standard Deviation|Mean
822482|NCT01163253|Primary|Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 36||Baseline, Month 36|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure.||IU/L||Standard Deviation|Mean
822483|NCT01163253|Primary|Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 24||Baseline, Month 24|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||IU/L||Standard Deviation|Mean
822484|NCT01163253|Primary|Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 12||Baseline, Month 12|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||IU/L||Standard Deviation|Mean
822485|NCT01163253|Primary|Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 6||Baseline, Month 6|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||IU/L||Standard Deviation|Mean
822486|NCT01163253|Primary|Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 3||Baseline, Month 3|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||IU/L||Standard Deviation|Mean
822487|NCT01163253|Primary|Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 1||Baseline, Month 1|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||international unit per liter (IU/L)||Standard Deviation|Mean
822488|NCT01163253|Primary|Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 48||Baseline, Month 48|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||mg/dL||Standard Deviation|Mean
822489|NCT01163253|Primary|Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 36||Baseline, Month 36|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||mg/dL||Standard Deviation|Mean
822490|NCT01163253|Primary|Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 24||Baseline, Month 24|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||mg/dL||Standard Deviation|Mean
822491|NCT01163253|Primary|Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 12||Baseline, Month 12|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||mg/dL||Standard Deviation|Mean
822492|NCT01163253|Primary|Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 6||Baseline, Month 6|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||mg/dL||Standard Deviation|Mean
822493|NCT01163253|Primary|Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 3||Baseline, Month 3|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||mg/dL||Standard Deviation|Mean
822494|NCT01163253|Primary|Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 1||Baseline, Month 1|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||milligram per deciliter (mg/dL)||Standard Deviation|Mean
822495|NCT01163253|Primary|Change From Baseline in Lymphocyte and Neutrophil Count at Month 48||Baseline, Month 48|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure.||1000 cells/mm^3||Standard Deviation|Mean
822496|NCT01163253|Primary|Change From Baseline in Lymphocyte and Neutrophil Count at Month 36||Baseline, Month 36|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure.||1000 cells/mm^3||Standard Deviation|Mean
822497|NCT01163253|Primary|Change From Baseline in Lymphocyte and Neutrophil Count at Month 24||Baseline, Month 24|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure.||1000 cells/mm^3||Standard Deviation|Mean
822498|NCT01163253|Primary|Change From Baseline in Lymphocyte and Neutrophil Count at Month 12||Baseline, Month 12|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure.||1000 cells/mm^3||Standard Deviation|Mean
822499|NCT01163253|Primary|Change From Baseline in Lymphocyte and Neutrophil Count at Month 6||Baseline, Month 6|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure.||1000 cells/mm^3||Standard Deviation|Mean
822500|NCT01163253|Primary|Change From Baseline in Lymphocyte and Neutrophil Count at Month 3||Baseline, Month 3|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure.||1000 cells/mm^3||Standard Deviation|Mean
822501|NCT01163253|Primary|Change From Baseline in Lymphocyte and Neutrophil Count at Month 1||Baseline, Month 1|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||1000 cells/mm^3||Standard Deviation|Mean
822502|NCT01163253|Primary|Change From Baseline in Hemoglobin Level at Month 48||Baseline, Month 48|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure.||g/dL||Standard Deviation|Mean
822503|NCT01163253|Primary|Change From Baseline in Hemoglobin Level at Month 36||Baseline, Month 36|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure.||g/dL||Standard Deviation|Mean
822504|NCT01163253|Primary|Change From Baseline in Hemoglobin Level at Month 24||Baseline, Month 24|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure.||g/dL||Standard Deviation|Mean
822505|NCT01163253|Primary|Change From Baseline in Hemoglobin Level at Month 12||Baseline, Month 12|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure.||g/dL||Standard Deviation|Mean
822506|NCT01163253|Primary|Change From Baseline in Hemoglobin Level at Month 6||Baseline, Month 6|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure.||g/dL||Standard Deviation|Mean
822507|NCT01163253|Primary|Change From Baseline in Hemoglobin Level at Month 3||Baseline, Month 3|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure.||g/dL||Standard Deviation|Mean
822508|NCT01163253|Primary|Change From Baseline in Hemoglobin Level at Month 1||Baseline, Month 1|Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies participants evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.||gram per deciliter (g/dL)||Standard Deviation|Mean
822509|NCT01163253|Primary|Number of Participants With Laboratory Abnormalities|Abnormality criteria: hematology (hemoglobin, hematocrit, red blood cell <0.8*lower limit of normal [LLN]; reticulocyte<0.5*LLN,>1.5*ULN; platelets<0.5*LLN,>1.75* upper limit of normal [ULN]; WBC<0.6*LLN, >1.5*ULN; lymphocytes, neutrophils, basophils, eosinophils, monocytes<0.8*LLN; >1.2*ULN; coagulation (prothrombin [PT], PT ratio>1.1*ULN) liver function (bilirubin>1.5*ULN, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma GT>0.3*ULN, protein, albumin<0.8*LLN; >1.2*ULN, globulin<0.5*LLN; >1.5*ULN); renal function (blood urea nitrogen, creatinine>1.3*ULN); electrolytes(sodium<0.95* LLN; >1.05* ULN, potassium, chloride, calcium, bicarbonate<0.9*LLN; >1.1*ULN), chemistry (glucose<0.6*LLN; >1.5* ULN), urinalysis (pH <4.5;>8, glucose, ketones, protein, blood, urobilinogen, nitrite, bilirubin, leukocyte esterase>=1; RBC, WBC>=20); lipids (cholesterol [C], LDL-C >1.3*ULN, HDL-C<0.8*LLN, triglycerides>1.3* ULN), hormones(T4, T3, T4, TSH<0.8* LLN; >1.2* ULN).|Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure.||participants|||Number
822606|NCT01163916|Primary|Characteristics of Patients Prescribed Adalimumab: Residence Status|Participants were asked to indicate their residence status within the Russian Federation at the Baseline visit.|Baseline|||participants|||Number
822607|NCT01163916|Primary|Characteristics of Patients Prescribed Adalimumab: Occupation|Participants were asked to indicate their occupation at the Baseline visit.|Baseline|||participants|||Number
822510|NCT01163253|Primary|Number of Adverse Events (AEs) by Severity|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs were classified according to the severity in 3 categories: a) mild: AEs did not interfere with participant’s usual function; b) moderate: AEs interfered to some extent with participant’s usual function; c) severe: AEs interfered significantly with participant’s usual function.|Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)|Safety analysis set included all participants who received at least 1 dose of study drug.||adverse events|||Number
822511|NCT01163253|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 4 weeks after last dose (up to 67 months) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.|Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)|Safety analysis set included all participants who received at least 1 dose of study drug.||participants|||Number
822512|NCT01163266|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from mixed model for repeated measurements (MMRM) ANCOVA with treatment, center, week, treatment-by-week interaction, Baseline SDS total score-by-week as fixed effects.|Baseline and Week 8|Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.||scores on a scale||Standard Error|Least Squares Mean
822513|NCT01163266|Secondary|Percentage of Participants in MADRS Remission at Week 8|Remission is defined as a participant with a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≤10. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.|Week 8|Full analysis set, last observation carried forward was used.||percentage of participants|||Number
822514|NCT01163266|Secondary|Change From Baseline in MADRS Total Score at Week 8 in Participants With Baseline Hamilton Anxiety Scale (HAM-A) Total Score ≥20|"The MADRS is a depression rating scale consisting of 10 items, each rated 0 (normal) to 6 (most abnormal). The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. LS means are from a mixed model for repeated measurements (MMRM) ANCOVA with treatment, center, week, treatment-by-week interaction, Baseline MADRS total score-by-week as fixed effects.
The HAM-A is a 14 item rating scale to quantify anxiety severity rated on a 5-point scale from 0 (not present) to 4 (severe) with a total score range from 0 to 56, where lower scores indicate mild severity."|Baseline and Week 8|Full analysis set patients with a HAM-A Baseline score ≥20. A mixed model for repeated measurements (MMRM) based on observed cases was used.||scores on a scale||Standard Error|Least Squares Mean
822515|NCT01163266|Secondary|Mean Clinical Global Impression Scale-Improvement (CGI-I) Score at Week 8|The Clinical Global Impression-Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from a mixed model for repeated measurements (MMRM) ANCOVA with treatment, center, week, treatment-by-week interaction, Baseline Clinical Global Impression Scale-Severity of Illness Scale (CGI-S) score-by-week as fixed effects.|Week 8|Full Analysis Set. A mixed model for repeated measurements (MMRM) based on observed cases was used.||scores on a scale||Standard Error|Least Squares Mean
822516|NCT01163266|Secondary|Percentage of Participants With a MADRS Response at Week 8|Response is defined as a participant with a ≥50% decrease in Montgomery Åsberg Depression Rating Scale (MADRS) total score from Baseline. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.|Baseline and Week 8|Full analysis set, last observation carried forward was used.||percentage of participants|||Number
822517|NCT01163266|Primary|Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score|The MADRS is a depression rating scale consisting of 10 items, each rated 0 (normal) to 6 (most abnormal). The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. Least squares (LS) means are from a mixed model for repeated measurements (MMRM) analysis of covariance (ANCOVA) with treatment, center, week, treatment-by-week interaction, Baseline MADRS total score-by-week as fixed effects.|Baseline and Week 8|The full analysis set (FAS) included all randomized patients who received at least 1 dose of study drug, and had at least 1 valid postbaseline value for assessment of primary efficacy. A mixed model for repeated measurements (MMRM) based on observed cases was used.||scores on a scale||Standard Error|Least Squares Mean
822518|NCT01163279|Secondary|DKEFS Trail Making- Condition 4: Number-letter Switching|DKEFS trail making condition 4 is a measure of executive function that requires the participant to switch back and forth between connecting numbers and letters in a sequence|Baseline, Immediately post intervention (2 months) and 3 months later|Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19).||Time in seconds||Standard Deviation|Mean
822519|NCT01163279|Secondary|DKEFS Word Fluency|This is a measure of executive function where participants are given a letter and asked to generate as many words as they can think of within 60 seconds|Baseline, Immediately post intervention (2 months) and 3 months later|Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19).||Number of words generated||Standard Deviation|Mean
822520|NCT01163279|Secondary|DKEFS Tower Test- Achievement Score|This is a measure of executive function. Total achievement scores indicate the highest score participants scored on the test. The lowest score possible is 0 and the highest score possible is 30. Higher scores indicate better performance.|Baseline, Immediately post intervention (2 months) and 3 months later|Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19).||units on a scale||Standard Deviation|Mean
822521|NCT01163279|Secondary|Delis Kaplan Executive Function System (DKEFS) Tower Test- Mean First-Move Time|This is a measure of executive function. The score reflects the average of the participant's first-move times, i.e. the time a participant took to make the first move|Baseline, Immediately post intervention (2 months) and 3 months later|Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19).||Time in seconds||Standard Deviation|Mean
822522|NCT01163279|Secondary|Stanford Patient Education Research Center- Visits to Physician and Emergency Department in the Past Six Months Subscale|Stanford Patient Education Research Center has different measures of health related behaviors. Visits to physician and emergency department in the past six months subscale is one of the subscales.|Baseline, Immediately post intervention (2 months) and 3 months later|Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19).||number of visits||Standard Deviation|Mean
822523|NCT01163279|Secondary|Stanford Patient Education Research Center- Communication With Physicians Subscale|Stanford Patient Education Research Center has different measures of health related behaviors. communication with physicians is one of the subscales. Scores range 1-15 and higher score indicates more preparation for visits and greater ability to ask questions|Baseline, Immediately post intervention (2 months) and 3 months later|Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19).||units on a scale||Standard Deviation|Mean
822524|NCT01163279|Secondary|Stanford Patient Education Research Center- Physical Activity Subscale|Stanford Patient Education Research Center has different measures of health related behaviors. Physical activity is one of the subscales. Scores indicate number of hours of physical activity per week|Baseline, Immediately post intervention (2 months) and 3 months later|Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19).||hours of physical activity/week||Standard Deviation|Mean
822525|NCT01163279|Secondary|Stanford Patient Education Research Center- Health Distress Subscale|Stanford Patient Education Research Center has different measures of health related behaviors. Health distress is one of the subscales. Scores range 0-20 and higher score indicates more distress.|Baseline, Immediately post intervention (2 months) and 3 months later|Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19).||units on a scale||Standard Deviation|Mean
822526|NCT01163279|Secondary|Stanford Patient Education Research Center- General Health Subscale|Stanford Patient Education Research Center has different measures of health related behaviors. General Health is one of the subscales. scores range 1-5 and higher score indicate better general health|Baseline, Immediately post intervention (2 months) and 3 months later|Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19).||units on a scale||Standard Deviation|Mean
822527|NCT01163279|Secondary|General Self Efficacy Scale (GSE)|GSE is a self efficacy scale with a minimum score of 10 and a maximum score of 40. Higher scores indicate higher self efficacy|Baseline, Immediately post intervention (2 months) and 3 months later|Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19).||Scores on scale||Standard Deviation|Mean
822528|NCT01163279|Primary|Total Number of Goals Improved to Criterion on the Canadian Occupational Performance Measure (COPM)|COPM is a standardized semi-structure interview in which participants identify goals related to everyday life activities. Goals considered improved to criterion are those that had 2 or more points increase on COPM ratings.|Immediately post intervention (2 months) and 3 months later|Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19).||percentage of untrained goals improved|Total number of goals||Number
822529|NCT01163292|Secondary|Number of Participants With Adverse Events (AEs)|Adverse events (AEs) were collected from week 0 till the end of the study. Please see Adverse Event section below for more details.|Week 0 to Week 52|All participants registered||participants|||Number
822530|NCT01163292|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI)|Participants assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Participants assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores included the following: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Negative mean changes from baseline in the disability index of the HAQ-DI indicated improvement.|Weeks 0, 26, and 52|All participants with post-baseline HAQ-DI data, using LOCF imputation method||units on a scale||Standard Deviation|Mean
822531|NCT01163292|Secondary|Modified Total Sharp Score (mTSS) Change From Week 0 to Week 52|Modified Total Sharp Score (mTSS) is a method of assessing radiographs used in evaluation of inhibition of joint destruction of disease. Digitized X-rays of hands and feet were obtained, then scored in a blinded manner: for erosion (0 [no damage] to 5 [complete collapse or total destruction of joint]) and for joint space narrowing (0 [no damage] to 4 [complete luxation of joint]). Sum of scores was given as total mTSS (0 [normal] to 380 [maximal disease]). Large positive change in mTSS indicates disease progression; small positive/no change indicates slowing/halting of disease progression.|Week 0 to Week 52|All participants with post-baseline mTSS data, using LOCF imputation method||units on a scale||Standard Deviation|Mean
822532|NCT01163292|Secondary|Matrix Metalloprotease-3 (MMP-3)|MMP-3 level in serum. Positive = >/= 121.0 ng/mL (male) and 59.7 ng/mL (female)|Weeks 0, 26, and 52|All participants with post-baseline MMP-3 data, using LOCF imputation method||units on a scale|||Number
822608|NCT01163916|Primary|Characteristics of Patients Prescribed Adalimumab: Education Level|Participants were asked to indicate their highest education level at the Baseline visit: secondary school, vocational school or college, university graduate, current university student, or other.|Baseline|||participants|||Number
824513|NCT01175018|Secondary|Incidence of Heart Failure|Difference between the anakinra arm and the placebo arm in number of patients with a new diagnosis or admission to the hospital for heart failure|10-14 weeks|||participants|||Number
822533|NCT01163292|Primary|Disease Activity Score (DAS28)|The Disease Activity Score (DAS28) is a combined index used to measure disease activity in participants with rheumatoid arthritis. Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate (ESR). DAS 28 (ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity); decrease is indicative of improvement in disease activity.|Weeks 0, 26, and 52|All participants with post-baseline DAS28 data, using last-observation-carried forward (LOCF) imputation method.||units on a scale||Standard Deviation|Mean
822534|NCT01163318|Secondary|Percentage of Participants With Modified Health Assessment Questionnaire (MHAQ) Score ≤ 0.5 by Visit|MHAQ was a participant-reported questionnaire that measured quality of life in terms of physical function of participants with rheumatic diseases. Participants assessed their ability to do each task over the past 6 months using the following response categories (score): without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score from 0 to 3, where 0 represented no disability and 3 very severe, high-dependency disability. MHAQ score ≤ 0.5 was defined as clinical remission, signifying normal physical function. Data are presented as percentage of participants.|Baseline (Week 0), Week 24, Year 1, Year 1.5, Year 2, Year 2.5, and Year 3|Efficacy analysis set, defined as safety analysis set excluding participants without evaluable DAS28-4ESR score and lack of Modified Health Assessment Questionnaire (MHAQ) data prior to drug administration.||Percentage of participants|||Number
822535|NCT01163318|Secondary|Percentage of Participants With Disease Activity Score 28 - 4 Erythrocyte Sedimentation Rate (DAS28-4ESR) < 2.6 by Visit|DAS28-4ESR, a combined index that measured activity of rheumatoid arthritis, was calculated based on: (1) the number of tender joints among 28 joints evaluated; (2) the number of swollen joints among 28 joints evaluated; (3) general health evaluated by a visual analog scale (VAS); and (4) ESR. DAS28-4ESR scores ranged from 0 (no disease activity) to 10 (maximal disease activity); decrease in DAS28-4ESR scores indicate improvement of disease. DAS28-4ESR score < 2.6 was defined as clinical remission of rheumatoid arthritis. Data are presented as percentage of participants.|Baseline (Week 0), Week 4, Week 12, Week 24, Year 1, Year 1.5, Year 2, Year 2.5, and Year 3|Efficacy analysis set, defined as safety analysis set excluding participants without evaluable DAS28-4ESR score and lack of Modified Health Assessment Questionnaire (MHAQ) data prior to drug administration.||Percentage of participants|||Number
822536|NCT01163318|Secondary|Incidence of Infections and Malignant Tumors|Participants were evaluated for the presence/absence of malignant tumors and infections. Data are presented as percentage of participants.|From the initiation of adalimumab treatment, every 6 months up to 3 years.|Safety analysis set, defined as participants who did not violate protocol criteria.||Percentage of participants|||Number
822537|NCT01163318|Primary|Incidence of Adverse Drug Reactions (ADRs)|An ADR was any unfavourable or unintended response (adverse event) that could possibly be related to adalimumab treatment. ADRs were assessed and data are presented as percentage of participants.|From the initiation of adalimumab treatment, every 6 months up to 3 years.|Safety analysis set, defined as participants who did not violate protocol criteria.||Percentage of participants|||Number
822538|NCT01163461|Primary|Speech Production|percent change in the number of untrained words spoken correctly|Baseline to one week post treatment termination and three months post treatment termination|||% change score of untrained real words||Standard Deviation|Mean
822539|NCT01163474|Secondary|Feasibility||1 month||||||
822540|NCT01163474|Secondary|Acceptability|Acceptability was assessed using a the Demeris 17-item Likert-scale questionnaire. Scale from 1 to 5 (1 = strongly disagree; 5 = strongly agree).|1 month|||units on a scale||Standard Deviation|Mean
822541|NCT01163474|Primary|Accuracy (FTF Decision on Patient Disposition vs. V-visit Decision on Patient Disposition)|Using CVT software and desktop webcams on the VA private network, “Virtual” CVT visits were conducted immediately prior to usual care of Face-to-Face (FTF) postoperative visits. Two independent surgeons reviewed the CVT recordings and made recommendations on patient dispositions. Accuracy was assessed by comparing the 2 reviewers’ CVT decisions to the FTF decision.|1 month|||percentage of agreement|||Number
822542|NCT01163604|Secondary|Clinical Endpoints||at one year||||||
822543|NCT01163604|Secondary|Various Adverse Effects||at one year||||||
822544|NCT01163604|Secondary|NIHSS, mRS|NIHSS and mRS are widely used stroke deficit assessment tools. Most clinical stroke-related trials require a baseline and outcome severity assessment. The baseline of mRS is rank 0, NIHSS 0; the severity of mRS is 6, NIHSS 42. AS many patients have one or more strokes before they perform stenting, this study selected NIHSS and mRS as the supplementary materials to estimate the stroke deficit of patients and to reflect the therapeutic effect and safety of stenting and argatroban therapy. These two scales are performed according to the guidance before and after stenting and argatroban therapy.|at one year||||||
822545|NCT01163604|Primary|Number of Participants With Occlusion and Restenosis at One Year|Stenosis detected by DSA(digital subtraction angiography),CTA(CT angiography)or MRA(MR angiography)was measured according to NASCET(North American Symptomatic Carotid Endarterectomy Trial)method.Concretely, NASCET stenosis is calculated from the ratio of the linear luminal diameter of the narrowest segment of the diseased portion of the artery to the diameter of the artery beyond any poststenotic dilatation: NASCET=(1-md/C)×100%|at one year|||participants|||Number
822546|NCT01163617|Secondary|Injection Duration for the Current Autoinjector When Administered at Room Temperature (20° to 27°C) Versus the Storage Temperature (2° to 8°C)|"A health care provider administered the injection to the participant, while another recorded the time elapsed during the injection (from the time of autoinjector activation, signaled by the audible click, until the yellow indicator stopped moving in the autoinjector view window). Injections were administered immediately following removal from the refrigerator (2° to 8°C) or after at least 30 minutes, but no more than 45 minutes, following removal from the refrigerator for the product to reach room temperature (20° to 27°C)."|Phase B (Week 4)|||seconds||90% Confidence Interval|Mean
822634|NCT01164475|Primary|Area Under the Concentration-time Curve From Time 0 to 10 Hours (AUC [0-10])||0 (pre-plerixafor dose), 0.5, 1, 4 hours post-plerixafor dose on Day 4; 9-10 hours post-plerixafor dose (pre G-CSF dose) on Day 5, 10-11 hours post-plerixafor dose (prior to first apheresis) on Day 5|FAS included all randomized patients who signed informed consent form and received at least one dose of plerixafor.||nanogram*hour per milliliter (ng*hr/mL)||Standard Error|Geometric Mean
822547|NCT01163617|Secondary|Injection Duration for the Current Autoinjector Compared to the Physiolis Autoinjector|"A health care provider administered the injection to the participant, while another recorded the time elapsed during the injection (from the time of autoinjector activation, signaled by the audible click, until the yellow indicator stopped moving in the autoinjector view window). Injections were administered immediately following removal from the refrigerator (2° to 8°C) or after at least 30 minutes, but no more than 45 minutes, following removal from the refrigerator for the product to reach room temperature (20° to 27°C)."|Phase B (Week 4)|||seconds||90% Confidence Interval|Mean
822548|NCT01163617|Primary|Injection Duration for the Physiolis Autoinjector at Room Temperature (20° to 27°C) and at Storage Temperature (2° to 8°C) Compared to the Current Autoinjector Ejection Time Specification of Not More Than 10 Seconds|"A health care provider administered the injection to the participant, while another recorded the time elapsed during the injection (from the time of autoinjector activation, signaled by the audible click, until the yellow indicator stopped moving in the autoinjector view window). Injections were administered immediately following removal from the refrigerator (2° to 8°C) or after at least 30 minutes, but no more than 45 minutes, following removal from the refrigerator for the product to reach room temperature (20° to 27°C)."|Phase B (Week 4)|||seconds||90% Confidence Interval|Mean
822549|NCT01163617|Primary|Participants' Overall Satisfaction With the Drug Administration Experience Using the Physiolis Syringe/Autoinjector in Comparison to the Current Syringe/Autoinjector|Participant's overall satisfaction of the injection was collected on a 10-cm visual analog scale (VAS) completed by participants immediately after self-injection. 0 = extremely unsatisfied, 10 = extremely satisfied.|Phase A (Week 0 and Week 2)|||cm||Standard Deviation|Mean
822550|NCT01163656|Primary|Time to Tracheal Intubation|The amount of time it takes the anesthesiologist to insert a breathing tube using one of two methods, either by direct laryngoscopy or using the Glidescope Cobalt Video system.|Measured the time of the randomized device past the teeth/gums until its removal after intubation as the time to intubation.|||seconds||95% Confidence Interval|Median
822551|NCT01163721|Primary|Change From Baseline in Fasting Serum Glucose at Week 12|Serum glucose was measured following an overnight fast. The LOCF method was used. Participants were summarized according to the actual treatment received regardless of the allocated treatment.|Baseline to Week 12|Full Analysis Set||mg/dL||Standard Error|Least Squares Mean
822552|NCT01163721|Primary|Change From Baseline in 2-hour Postprandial Serum Glucose at Week 12 Following a Standardized Meal|2-hour postprandial serum glucose was defined as the average of serum glucose measurement at 120 minutes and 125 minutes following a standardized meal. The LOCF method was used. Participants were summarized according to the actual treatment received regardless of the allocated treatment.|Baseline to Week 12|Participants in the Full Analysis Set with available data were analyzed.||mg/dL||Standard Error|Least Squares Mean
822553|NCT01163721|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12|HbA1c is a blood test to measure blood sugar control over the prior 3-month period. The last observation carried forward (LOCF) method was used: the last observed post-baseline measurements prior to Week 12 carried forward for participants with no available Week 12 values. Participants were summarized according to the actual treatment received regardless of the allocated treatment.|Baseline to Week 12|Participants in the Full Analysis Set with available data were analyzed.||percent of HbA1c in blood||Standard Error|Least Squares Mean
822554|NCT01163747|Secondary|Number of Participants With Adverse Events Through Week 8|An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A Serious Adverse Event (SAE) is any AE that is fatal or is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is medically significant or requires intervention to prevent one or other of the outcomes listed above.|8 weeks|All participants who received at least one dose of study treatment were included in the safety evaluation.||participants|||Number
822555|NCT01163747|Secondary|Percentage of Participants Who Responded to Each of the 12 Anti-Pneumococcal Antibody Serotypes|"Serum levels of antibody to pneumococcal vaccine were drawn 5 weeks after vaccination with 23-valent pneumococcal polysaccharide vaccine to assess humoral immune response. A positive response to the pneumococcal vaccine was defined as a 2-fold increase in serum antibody titers from Baseline or an increase of > 1 mg/L from Baseline levels.
The 12 serotypes evaluated were pneumococcal serotypes 1, 3, 4, 6B, 7F, 8, 9N, 12F, 14, 18C, 19F and 23F."|Baseline (Week 3) and Week 8 (5 weeks post-vaccination)|Evaluable per protocol population for pneumococcal polysaccharide vaccine. N indicates the number of participants with available data for each serotype. No imputation was performed.||percentage of participants|||Number
822556|NCT01163747|Secondary|Change From Baseline in Levels of Anti-tetanus Antibody 5 Weeks After Vaccination|Levels of anti-tetanus antibodies were measured by a central laboratory from serum samples taken prior to vaccination (Week 3) and 5 weeks post vaccination (Week 8).|Baseline (Week 3) and Week 8 (5 weeks post-vaccination)|Evaluable per protocol population for tetanus toxoid vaccine: participants who received at least one dose of study medication, had no major protocol violations, had both baseline (Week 3) and Week 8 assessments of response with evaluable titers to the tetanus toxoid vaccine.||IU/mL||Standard Deviation|Mean
822557|NCT01163747|Secondary|Change From Baseline in Levels of Anti-pneumococcal Antibody 5 Weeks After Vaccination|Levels of anti-pneumococcal antibodies were measured by a central laboratory from serum samples taken prior to vaccination (Week 3) and 5 weeks post vaccination (Week 8).|Baseline (Week 3) and Week 8 (5 weeks post-vaccination)|Evaluable per protocol population for pneumococcal polysaccharide vaccine: participants who received at least one dose of study medication, had no major protocol violations, had both baseline (Week 3) and Week 8 assessments of response with evaluable titers to the pneumococcal vaccine.||mg/L||Standard Deviation|Mean
822558|NCT01163747|Secondary|Percentage of Participants With a Positive Response to Tetanus Toxoid Vaccination|A positive response to the tetanus toxoid vaccination was defined as antibody levels ≥ 0.2 IU/mL for participants with Baseline tetanus antibody levels < 0.1 IU/mL, or a 4-fold increase in antibody levels compared with Baseline for participants with Baseline tetanus antibody levels ≥ 0.1 IU/mL.|Baseline (Week 3) and Week 8 (5 weeks post-vaccination)|Evaluable per protocol population for tetanus toxoid vaccine: participants who received at least one dose of study medication, had no major protocol violations, had both baseline (Week 3) and Week 8 assessments of response with evaluable titers to the tetanus toxoid vaccine.||percentage of participants||95% Confidence Interval|Number
822559|NCT01163747|Secondary|Percentage of Participants Who Responded to Combinations of 12 Anti-Pneumococcal Antibody Serotypes|"Serum levels of antibody to pneumococcal vaccine were drawn 5 weeks after vaccination with 23-valent pneumococcal polysaccharide vaccine to assess humoral immune response. A positive response to the pneumococcal vaccine was defined as a 2-fold increase in serum antibody titers from Baseline or an increase of > 1 mg/L from Baseline levels.
The 12 serotypes evaluated were pneumococcal serotypes 1, 3, 4, 6B, 8, 9N, 12F, 14, 19F, 23F, 7F, and 18C."|Baseline (Week 3) and Week 8 (5 weeks post-vaccination)|Evaluable per protocol population for pneumococcal polysaccharide vaccine: participants who received at least one dose of study medication, had no major protocol violations, had both baseline (Week 3) and Week 8 assessments of response with evaluable titers to the pneumococcal vaccine.||percentage of participants||95% Confidence Interval|Number
822560|NCT01163747|Primary|Percentage of Participants Who Responded to ≥ 6 of 12 Anti-pneumococcal Antibody Serotypes|"Serum levels of antibody to pneumococcal vaccine were drawn 5 weeks after vaccination with 23-valent pneumococcal polysaccharide vaccine to assess humoral immune response. A positive response to the pneumococcal vaccine was defined as a 2-fold increase in serum antibody titers from Baseline or an increase of > 1 mg/L from Baseline levels.
The 12 serotypes evaluated were pneumococcal serotypes 1, 3, 4, 6B, 8, 9N, 12F, 14, 19F, 23F, 7F, and 18C."|Baseline (Week 3) and Week 8 (5 weeks post-vaccination)|Evaluable per protocol population for pneumococcal polysaccharide vaccine: participants who received at least one dose of study medication, had no major protocol violations, had both baseline (Week 3) and Week 8 assessments of response with evaluable titers to the pneumococcal vaccine.||percentage of participants||95% Confidence Interval|Number
822561|NCT01163760|Other Pre-specified|Comfort While Working on Computer|"Comfort throughout the day was evaluated via subjective question: Comfort while working on computer and is reported as an aggregate of Agree Strongly and Agree Somewhat."|1-week-follow-up|||percentage of participants|||Number
822562|NCT01163760|Secondary|Comfort Throughout the Whole Day|"Comfort throughout the day was evaluated via subjective question: Comfort throughout the whole day and is reported as an aggregate of Agree Strongly and Agree Somewhat."|1-week follow-up|Subjects analyzed were those enrolled, randomized, and completed the study.||percentage of participants|||Number
822563|NCT01163760|Primary|Lens Comfort|"Lens comfort was evaluated via the subjective question: How comfortable did your eyes feel at the end of the day when wearing the contact lenses you were provided? (excellent/very good=5...very good=3...Poor=0)"|1-week follow-up|Subjects analyzed were those who were enrolled, randomized, and completed the study.||units on a scale||Standard Deviation|Mean
822564|NCT01163851|Secondary|Number of Participants With Systemic Treatment Emergent Adverse Events (TEAEs) Identified by Laboratory Parameters|Laboratory parameters alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, gamma glutamyl transferase, lactate dehydrogenase, albumin, hemoglobin, protein, amylase, creatine kinase, lipase, basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets, white blood cells, bicarbonate, chloride, potassium, sodium, bilirubin, blood urea nitrogen, c-reactive protein , calcium, creatinine, direct bilirubin, glucose, magnesium, phosphate, uric acid, hematocrit, partial thromboplastin time , prothrombin time, red blood cells , urine pH, urine specific gravity were assessed to identify systemic TEAEs. TEAEs (all causalities), treatment related TEAEs and CTCAE severity grades for AEs were reported. Same participant may be reported in more than 1 CTCAE severity grade.|Baseline up to Day 64|SAS population included all participants who met the study enrollment criteria and had received any amount of study medication.||participants|||Number
822565|NCT01163851|Secondary|Number of Participants With Systemic Treatment Emergent Adverse Events (TEAEs) Identified by Electrocardiogram (ECG) Parameters|ECG is used to measure the rate and regularity of heartbeats, as well as the size and position of the chambers, the presence of any damage to the heart, and the effects of drugs or devices used to regulate the heart. ECG parameters RR interval, PR interval, QRS complex, QT interval, [Bazett's Correction], QTcF interval [Fridericia's Correction] were assessed to identify systemic TEAEs. TEAEs (all causalities), treatment related TEAEs and CTCAE severity grades for AEs were reported.|Baseline up to Day 64|SAS population included all participants who met the study enrollment criteria and had received any amount of study medication.||participants|||Number
822566|NCT01163851|Secondary|Number of Participants With Systemic Treatment Emergent Adverse Events (TEAEs) Identified by Vital Signs|Vital sign parameters body temperature, blood pressure and heart rate were assessed to identify systemic TEAEs. TEAEs (all causalities), treatment related TEAEs and CTCAE severity grades for AEs were reported. Same participant may be reported in more than 1 CTCAE severity grade.|Baseline up to Day 64|SAS population included all participants who met the study enrollment criteria and had received any amount of study medication.||participants|||Number
822567|NCT01163851|Secondary|Number of Participants With Anti-Drug-Antibodies (ADA)|Participants with positive antibody titer greater than 0 International Units/milliliter (IU/mL) was considered as antibody positive.|Baseline up to Day 64|SAS population included all participants who met the study enrollment criteria and had received any amount of study medication.||participants|||Number
822568|NCT01163851|Secondary|Number of Participants With Systemic Treatment Emergent Adverse Events (TEAEs) Identified by Physical Examination|Complete physical examination was conducted to assess skin, ears, throat, cardiac, respiratory, gastrointestinal, and musculoskeletal systems for systemic TEAEs.|Baseline up to Day 64|SAS population included all participants who met the study enrollment criteria and had received any amount of study medication.||participants|||Number
822569|NCT01163851|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 64 days after last dose that were absent before treatment or that worsened relative to pretreatment state. TEAEs (all causalities), treatment related TEAEs and common terminology criteria for adverse events (CTCAE) severity grades for AEs were reported. Same participant may be reported in more than 1 CTCAE severity grade.|Baseline up to Day 64|SAS population included all participants who met the study enrollment criteria and had received any amount of study medication.||participants|||Number
822570|NCT01163851|Secondary|Number of Participants With Toxicity or Intolerable Dose Criteria|Toxicity criteria included any of the following : serious adverse event (SAE), increased liver transaminases (alanine aminotransferase [ALT]/aspartate aminotransferase (AST) , increased bilirubin (in absence of ALT/AST elevations), pancreatitis, creatine kinase (CK) , hyper or hypoglycemia, decreased platelet count, increased serum creatinine, diarrhea, enteritis or nausea, prolongation of QTcF interval [Fridericia's Correction] and other considered appropriate by investigator.|Baseline, Days 1, 2, 3, 4, 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64|Safety Analysis Set (SAS) population included all participants who met the study enrollment criteria and had received any amount of study medication.||participants|||Number
822571|NCT01163851|Secondary|Durability of Additional Lipid Lowering Effects of PF-04950615 (RN316) in Combination With Atorvastatin on Days 4-64|The median duration of the lipid-lowering effects (decrease in LDL-C levels by greater than or equal to 15 percent [%] compared to baseline) of PF-04950615 in combination with atorvastatin from Days 4 to 64 was reported.|Day 4 to Day 64|Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest.||days||Full Range|Median
822572|NCT01163851|Secondary|Percent Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|ApoA1 is a major protein that is a component of HDL cholesterol and helps in clearing cholesterol from the blood by removing cholesterol from organs and tissues to be destroyed by the liver.. Fasting was required at least 10 hours before blood sample collection. Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 (RN316) administration.|Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64|Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest.||percent change||Standard Deviation|Mean
822573|NCT01163851|Secondary|Percent Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|HDL cholesterol is cholesterol in the bloodstream that is carried by high density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 (RN316) administration.|Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64|Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest.||percent change||Standard Deviation|Mean
822574|NCT01163851|Secondary|Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|ApoB is a major protein that makes up LDL cholesterol and is involved in transporting cholesterol and triglycerides to cells and tissues in the body. Fasting was required at least 10 hours before blood sample collection. Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 (RN316) administration.|Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64|Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest.||percent change||Standard Deviation|Mean
822575|NCT01163851|Secondary|Percent Change From Baseline in Fasting Triglycerides Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|Triglycerides are a type of fat circulating in the blood and account for the majority of the fats circulating in the blood. Fasting was required at least 10 hours before blood sample collection. Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 (RN316) administration.|Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64|Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest.||percent change||Standard Deviation|Mean
822576|NCT01163851|Secondary|Percent Change From Baseline in Fasting Non-High-density Lipoprotein-cholesterol (Non-HDL-C) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|Non-HDL-C calculated as total cholesterol minus HDL cholesterol. Fasting was required at least 10 hours before blood sample collection. Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 (RN316) administration.|Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64|Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest.||percent change||Standard Deviation|Mean
822577|NCT01163851|Secondary|Percent Change From Baseline in Total Cholesterol Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|Total cholesterol is the sum of all the cholesterol within the blood. Fasting was required at least 10 hours before blood sample collection. Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 (RN316) administration.|Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64|Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest.||percent change||Standard Deviation|Mean
822578|NCT01163851|Secondary|Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|LDL cholesterol is cholesterol in the bloodstream that is carried by low density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 (RN316) administration.|Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64|Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest. Here, 'n' is signifying those participants who were evaluable for particular category for each arm group respectively.||percent change||Standard Deviation|Mean
822579|NCT01163851|Secondary|Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|HDL cholesterol is cholesterol in the bloodstream that is carried by high density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 (RN316) administration.|Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64|Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest.||mg/dL||Standard Deviation|Mean
822670|NCT01164722|Secondary|Tolerability and Safety of Infrared Coagulator Ablation|Number of patients who experienced a serious adverse events|All study visits through year 2|||participants|||Number
824514|NCT01175018|Secondary|Median Difference Between the 2 Arms in the Peak Oxygen Consumption (VO2) at 10-14 Weeks||10-14 weeks|||ml*kg^-1*min^-1||Inter-Quartile Range|Median
822580|NCT01163851|Secondary|Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|ApoA1 is a major protein that is a component of HDL cholesterol and helps in clearing cholesterol from the blood by removing cholesterol from organs and tissues to be destroyed by the liver. Fasting was required at least 10 hours before blood sample collection. Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 (RN316) administration.|Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64|Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest.||mg/dL||Standard Deviation|Mean
822581|NCT01163851|Secondary|Change From Baseline in Fasting Apolipoprotein B (ApoB) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|ApoB is a major protein that makes up LDL cholesterol and is involved in transporting cholesterol and triglycerides to cells and tissues in the body. Fasting was required at least 10 hours before blood sample collection. Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 (RN316) administration.|Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64|Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest.||mg/dL||Standard Deviation|Mean
822582|NCT01163851|Secondary|Change From Baseline in Fasting Triglycerides Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|Triglycerides are a type of fat circulating in the blood and account for the majority of the fats circulating in the blood. Fasting was required at least 10 hours before blood sample collection. Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 (RN316) administration.|Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64|Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest.||mg/dL||Standard Deviation|Mean
822583|NCT01163851|Secondary|Change From Baseline in Fasting Non-High-density Lipoprotein-Cholesterol (Non-HDL-C) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|Non-HDL-C calculated as total cholesterol minus HDL cholesterol. Fasting was required at least 10 hours before blood sample collection. Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 (RN316) administration.|Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64|Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest.||mg/dL||Standard Deviation|Mean
822584|NCT01163851|Secondary|Change From Baseline in Fasting Total Cholesterol Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|Total cholesterol is the sum of all the cholesterol within the blood. Fasting was required at least 10 hours before blood sample collection. Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 (RN316) administration.|Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64|Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest.||mg/dL||Standard Deviation|Mean
822585|NCT01163851|Secondary|Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|LDL cholesterol is cholesterol in the bloodstream that is carried by low density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 (RN316) administration.|Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64|Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest. Here, 'n' is signifying those participants who were evaluable for particular category for each arm group respectively.||milligram/deciliter (mg/dL)||Standard Deviation|Mean
822586|NCT01163851|Primary|Apparent Volume of Distribution (Vz/F) of Atorvastatin|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose on Day 4, pre atorvastatin dose on Day 5, 6 and 7|PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.||liter||Standard Deviation|Geometric Mean
822587|NCT01163851|Primary|Apparent Oral Clearance (CL/F) of Atorvastatin|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose on Day 4, pre atorvastatin dose on Day 5, 6 and 7|PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest.||L/hr||Standard Deviation|Geometric Mean
822588|NCT01163851|Primary|Plasma Decay Half-Life (t1/2) of Atorvastatin|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose on Day 4, pre atorvastatin dose on Day 5, 6 and 7|PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure for each group respectively.||hrs||Standard Deviation|Mean
822589|NCT01163851|Primary|Maximum Observed Plasma Concentration (Cmax) of Atorvastatin||0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose on Day 4, pre atorvastatin dose on Day 5, 6 and 7|PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest.||ng/mL||Standard Deviation|Geometric Mean
822590|NCT01163851|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Atorvastatin||0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose on Day 4, pre atorvastatin dose on Day 5, 6 and 7|PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest.||hrs||Full Range|Median
822591|NCT01163851|Primary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Atorvastatin||0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose on Day 4, pre atorvastatin dose on Day 5, 6 and 7|PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest.||ng*hr/mL||Standard Deviation|Geometric Mean
822592|NCT01163851|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of PF-04950615 (RN316)|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|0 (pre-dose on Day 4), 1, 4, 8 and 12 hrs post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure for each group respectively.||ng*hr/mL||Standard Deviation|Geometric Mean
822593|NCT01163851|Primary|Volume of Distribution at Steady State (Vss) of PF-04950615 (RN316)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.|0 (pre-dose on Day 4), 1, 4, 8 and 12 hrs post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure for each group respectively.||liter||Standard Deviation|Geometric Mean
822594|NCT01163851|Primary|Systemic Clearance (CL) of PF-04950615 (RN316)|CL is a quantitative measure of the rate at which a drug substance is removed from the body.|0 (pre-dose on Day 4), 1, 4, 8 and 12 hrs post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure for each group respectively.||liter/hour (L/hr)||Standard Deviation|Geometric Mean
822595|NCT01163851|Primary|Plasma Decay Half-Life (t1/2) of PF-04950615 (RN316)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose on Day 4), 1, 4, 8 and 12 hrs post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure for each group respectively.||hrs||Standard Deviation|Mean
822596|NCT01163851|Primary|Maximum Observed Plasma Concentration (Cmax) of PF-04950615 (RN316)||0 (pre-dose on Day 4), 1, 4, 8 and 12 hrs post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest.||ng/mL||Standard Deviation|Geometric Mean
822597|NCT01163851|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04950615 (RN316)||0 (pre-dose on Day 4), 1, 4, 8 and 12 hrs post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest.||hrs||Full Range|Median
822598|NCT01163851|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-04950615 (RN316)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).|0 (pre-dose on Day 4), 1, 4, 8 and 12 hours (hrs) post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|Pharmacokinetic (PK) parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest.||nanogram*hour/milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
822599|NCT01163916|Secondary|Duration of Treatment With Adalimumab|Tolerability to adalimumab treatment was analyzed by the time on treatment until development of an adverse event leading to adalimumab discontinuation or until discontinuation from treatment for any other reason.|For the duration of the study (up to a maximum of 18.2 months).|Safety set.||weeks||Full Range|Median
822600|NCT01163916|Primary|Characteristics of Patients Prescribed Adalimumab: Other Disease Specific Treatment|Data on other medications (methotrexate, non-steroidal anti-inflammatory drugs [NSAIDs], corticosteroids and other medications) taken for the participant's condition (rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis) were collected at the Baseline visit and at each follow-up visit throughout the study. Overall data are presented.|Baseline and at each follow-up visit (up to a maximum of 18.2 months).|Safety set||participants|||Number
822601|NCT01163916|Primary|Characteristics of Patients Prescribed Adalimumab: Duration of Disease|Duration of disease was defined as the time from diagnosis until study entry.|Baseline|Safety set||months||Full Range|Median
822602|NCT01163916|Primary|Characteristics of Patients Prescribed Adalimumab: Disease Severity|Disease severity was assessed by the physician as mild, moderate or severe, based on routine clinical practice.|Baseline|Safety set.||participants|||Number
822603|NCT01163916|Primary|Characteristics of Patients Prescribed Adalimumab: Marital Status|Participants were asked to indicate their marital status at the Baseline visit.|Baseline|||participants|||Number
822604|NCT01163916|Secondary|Percentage of Participants With Missed or Delayed Injections|Compliance with prescribed adalimumab therapy was assessed by the percentage of participants with missed injections and/or injections delayed by more than 7 days.|For the duration of the study (up to a maximum of 18.2 months).|Safety set; the analysis only includes participants with non-missing data.||percentage of participants|||Number
822605|NCT01163916|Secondary|Patient's Acceptability of Self-injections|"At each clinic visit participants were asked to rate the convenience of adalimumab injections. Possible options were convenient, inconvenient and unable to self-inject.
The study follow-up period consisted of approximately 6 follow-up visits occurring at average intervals of 2-3 months, according to routine clinical practice.
Acceptability data are reported by follow-up visit and by treatment regimen: 40 mg every other week or 40 mg once a week, as prescribed in accordance with local marketing authorization."|Data were collected at study follow-up visits (Visits 1-6) which occurred on average at 2-3 month intervals, up to a maximum of 18.2 months.|The number of participants analyzed (251) represents the total number of participants in the safety set. The number of participants with available data at each follow-up visit were: Visit 1: 249; Visit 2: 246; Visit 3: 237; Visit 4: 205; Visit 5: 179; Visit 6: 135.||participants|||Number
822609|NCT01163955|Primary|Posture Control of Head Position, Shoulder Position and Back Position|Forward Head Position (FHP), Rounded Shoulder Position (RSP), and Thoracic spine (T/s)-Lumbar spine (L/s) positions were scored. Subscale scores of 0-3 for each FHP, RSP, and T/s L/s position were obtained. Score 0 was a perfect posture score, Score 1 was 0-1 inches out of alignment. Score 2 was 1-2 inches out of alignment. Score 3 was 2-3 inches out of alignment. Subscale scores were combined for a total score with a minimum value of 0 and a maximum value of 9. 0 being a perfect posture score, 9 being the worst postural score.|5 minute|||scores on a scale||95% Confidence Interval|Mean
822610|NCT01164007|Secondary|Overall Survival (OS)|OS was defined as the time from Baseline visit to the time of death from any cause. OS was estimated by Kaplan-Meier methodology and expressed in months.|Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)|ITT Population||months||95% Confidence Interval|Median
822611|NCT01164007|Secondary|Percentage of Participants Who Died|The percentage of participants who died from any cause was reported.|Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)|ITT Population||percentage of participants|||Number
822612|NCT01164007|Secondary|Time to Treatment Failure (TTF)|TTF was defined as the time from start of treatment to the time of treatment discontinuation as a result of death, adverse event, disease progression, loss to follow-up, non-compliance, or consent withdrawal was reported. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to smallest sum on study or the appearance of new lesion(s). TTF was estimated by Kaplan-Meier methodology and expressed in months.|Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)|ITT Population||months||95% Confidence Interval|Median
822613|NCT01164007|Secondary|Percentage of Participants Who Discontinued Treatment|The percentage of participants who discontinued treatment as a result of death, adverse event, disease progression, loss to follow-up, non-compliance, or consent withdrawal was reported. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to smallest sum on study or the appearance of new lesion(s).|Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)|ITT Population||percentage of participants|||Number
822614|NCT01164007|Secondary|Time to Progression (TTP) According to RECIST|Tumor assessments were performed using RECIST. TTP was defined as the time from Baseline visit to time of death or disease progression, whichever occurred first. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to smallest sum on study or the appearance of new lesion(s). TTP was estimated by Kaplan-Meier methodology and expressed in months.|Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)|ITT Population||months||95% Confidence Interval|Median
822615|NCT01164007|Secondary|Percentage of Participants With Death or Disease Progression According to RECIST|Tumor assessments were performed using RECIST. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to smallest sum on study or the appearance of new lesion(s). The percentage of participants who died or demonstrated disease progression was reported.|Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)|ITT Population||percentage of participants|||Number
822616|NCT01164007|Secondary|DOR With CR, PR, or SD According to RECIST|Tumor assessments were performed using RECIST. DOR was defined as the time from first assessment of CR, PR, or SD to the time of death or disease progression, whichever occurred first. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to smallest sum on study or the appearance of new lesion(s). CR was defined as disappearance of all target and non-target lesions with normalization of tumor markers. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. SD was defined as neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for disease progression, using smallest sum of LD on study as reference. DOR was estimated by Kaplan-Meier methodology and expressed in months.|Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)|"ITT Population. The Number of Participants Analyzed reflects the number of participants with a previous assessment of CR, PR, or SD."||months||95% Confidence Interval|Median
822617|NCT01164007|Secondary|Percentage of Participants With Death or Disease Progression Following a Previous Assessment of CR, PR, or Stable Disease (SD) According to RECIST|Tumor assessments were performed using RECIST. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to smallest sum on study or the appearance of new lesion(s). CR was defined as disappearance of all target and non-target lesions with normalization of tumor markers. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. SD was defined as neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for disease progression, using smallest sum of LD on study as reference. The percentage of participants who died or demonstrated disease progression among those with a previous assessment of CR, PR, or SD was reported.|Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)|"ITT Population. The Number of Participants Analyzed reflects the number of participants with a previous assessment of CR, PR, or SD."||percentage of participants|||Number
822618|NCT01164007|Secondary|Duration of Response (DOR) With CR or PR According to RECIST|Tumor assessments were performed using RECIST. DOR was defined as the time from first assessment of CR or PR to the time of death or disease progression, whichever occurred first. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to smallest sum on study or the appearance of new lesion(s). CR was defined as disappearance of all target and non-target lesions with normalization of tumor markers. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. DOR was estimated by Kaplan-Meier methodology and expressed in months.|Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)|"ITT Population. The Number of Participants Analyzed reflects the number of participants with a previous assessment of CR or PR."||months||95% Confidence Interval|Median
822671|NCT01164722|Primary|Complete Response Through 1 Year|No detection of high grade anal intraepithelial neoplasia (HGAIN) from treatment through one year. Detection of HGAIN was based on local pathology reports.|1 year post treatment|All study participants who were randomized and attended the baseline visit.||participants|||Number
824515|NCT01175018|Secondary|Percentage of Patients in Each Group With Reverse Remodeling (Reduction in LVESVi >5%)||10-14 weeks|||% of participants|||Number
822619|NCT01164007|Secondary|Percentage of Participants With Death or Disease Progression Following a Previous Assessment of CR or PR According to RECIST|Tumor assessments were performed using RECIST. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to smallest sum on study or the appearance of new lesion(s). CR was defined as disappearance of all target and non-target lesions with normalization of tumor markers. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. The percentage of participants who died or demonstrated disease progression among those with a previous assessment of CR or PR was reported.|Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)|"ITT Population. The Number of Participants Analyzed reflects the number of participants with a previous assessment of CR or PR."||percentage of participants|||Number
822620|NCT01164007|Primary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST)|Tumor assessments were performed using RECIST. CR was defined as disappearance of all target and non-target lesions with normalization of tumor markers. PR was defined as greater than or equal to (≥) 30 percent (%) decrease in sum of longest diameter (LD) of target lesions in reference to sum of LD at Baseline. Both were to be confirmed at a follow-up visit at least 4 weeks from the initial assessment of CR or PR. The percentage of participants with a best overall response of CR or PR during the study was reported.|Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)|Intent-to-Treat (ITT) Population: All participants who signed the ICF, were assigned a study identifier, and received at least one dose of study medications.||percentage of participants|||Number
822621|NCT01164137|Primary|Health Services Utilization 18 Months Following Hospital Discharge|Mean health services utilization 18 months following hospital discharge. The specific health services utilization was re-admission to hospital, admission to home care, admission to long-term care and visits to emergency departments.|18 months|||Health Services Utilizations||Standard Error|Mean
822622|NCT01164137|Primary|Health Services Utilization 12 Months Following Hospital Discharge|Mean health services utilization 12 months following hospital discharge. The specific health services utilization was re-admission to hospital, admission to home care, admission to long-term care and visits to emergency departments.|12 months|||Health Services Utilizations||Standard Error|Mean
822623|NCT01164137|Primary|Health Services Utilization 9 Months Following Hospital Discharge|Mean health services utilization 9 months following hospital discharge. The specific health services utilization was re-admission to hospital, admission to home care, admission to long-term care and visits to emergency departments.|9 Months|||Health Services Utilizations||Standard Error|Mean
822624|NCT01164137|Primary|Health Services Utilization 6 Months Following Hospital Discharge|Mean health services utilization 6 months following hospital discharge. The specific health services utilization was re-admission to hospital, admission to home care, admission to long-term care and visits to emergency departments.|6 Months|||Health Services Utilizations||Standard Error|Mean
822625|NCT01164137|Primary|Health Services Utilization 3 Months Following Hospital Discharge|Mean health services utilization 3 months following hospital discharge. The specific health services utilization was re-admission to hospital, admission to home care, admission to long-term care and visits to emergency departments.|3 Months|||Health Services Utilizations||Standard Error|Mean
822626|NCT01164475|Secondary|Terminal Elimination Half-life (T1/2)|T1/2 is the time required for the plasma concentration to decrease to one half.|0 (pre-plerixafor dose), 0.5, 1, 4 hours post-plerixafor dose on Day 4; 9-10 hours post-plerixafor dose (pre G-CSF dose) on Day 5, 10-11 hours post-plerixafor dose (prior to first apheresis) on Day 5|FAS included all randomized patients who signed informed consent form and received at least one dose of plerixafor.||hours||Standard Deviation|Mean
822627|NCT01164475|Secondary|Time to Reach Maximum Plasma Concentration (Tmax)||0 (pre-plerixafor dose), 0.5, 1, 4 hours post-plerixafor dose on Day 4; 9-10 hours post-plerixafor dose (pre G-CSF dose) on Day 5, 10-11 hours post-plerixafor dose (prior to first apheresis) on Day 5|FAS included all patients who have signed informed consent and received at least one dose of study drug.||hours||Full Range|Median
822628|NCT01164475|Secondary|Maximum Observed Plasma Concentration (Cmax)||0 (pre-plerixafor dose), 0.5, 1, 4 hours post-plerixafor dose on Day 4; 9-10 hours post-plerixafor dose (pre G-CSF dose) on Day 5, 10-11 hours post-plerixafor dose (prior to first apheresis) on Day 5|FAS included all randomized patients who signed informed consent form and received at least one dose of plerixafor.||ng/mL||Standard Deviation|Mean
822629|NCT01164475|Secondary|Mean Fold Increase in Peripheral Blood CD34+ Cell Count Following Plerixafor|Fold increase was calculated as CD34+ cell count on Day 5 divided by CD34+ cell count on Day 4.|Baseline (pre G-CSF dose on Day 4) to Day 5 (prior to first apheresis)|FAS included all randomized patients who signed informed consent form and received at least one dose of plerixafor.||fold increase||Standard Deviation|Mean
822630|NCT01164475|Secondary|Total Number of CD34+ Cells/kg Collected Over up to 4 Aphereses|The cumulative number of CD34+ cells/kg (body weight) collected over all apheresis sessions (up to a maximum of 4 sessions) was reported.|Day 5 up to Day 8|FAS included all randomized patients who signed informed consent form and received at least one dose of plerixafor.||10^6 cells/kg||Full Range|Median
822631|NCT01164475|Secondary|Median Number of Days of Apheresis to Collect at Least 5*10^6 CD34+ Cells/kg||Day 5 up to Day 8|FAS included all randomized patients who signed informed consent form and received at least one dose of plerixafor. Here, number of patients analyzed = the number of patients who were evaluable for this outcome measure.||days||Full Range|Median
822632|NCT01164475|Secondary|Median Number of Days of Apheresis to Collect at Least 2*10^6 CD34+ Cells/kg||Day 5 up to Day 8|FAS included all randomized patients who signed informed consent form and received at least one dose of plerixafor. Here, number of patients analyzed = the number of patients who were evaluable for this outcome measure.||days||Full Range|Median
822633|NCT01164475|Secondary|Proportion of Patients Who Achieved at Least 2*10^6 CD34+ Cells/kg in Less Than or Equal to 4 Days of Apheresis|The cumulative number of CD34+ cells/kg (body weight) collected over all apheresis sessions (up to a maximum of 4 sessions) was used to determine if a patient has achieved the target of >= 2*10^6 CD34+ cells/kg (minimum number of CD34+ cells required for transplantation) within 4 days of apheresis. The proportion of patients who achieved the target was reported as percentages for each treatment arm.|Day 5 up to Day 8|FAS included all randomized patients who signed informed consent form and received at least one dose of plerixafor.||percentage of participants|||Number
822635|NCT01164475|Primary|Proportion of Patients Who Achieved at Least 5*10^6 Cluster of Differentiation 34+ (CD34+) Cells Per Kilogram (Cells/kg)|The cumulative number of CD34+ cells/kg (body weight) collected over all apheresis sessions (up to a maximum of 4 sessions) was used to determine if a patient has achieved the target of >=5*10^6 CD34+ cells/kg (optimum number of CD34+ cells required for transplantation) within 4 days of apheresis. The proportion of patients who achieved the target was reported as percentages for each treatment arm.|Day 5 up to Day 8|FAS included all randomized patients who signed informed consent form and received at least one dose of plerixafor.||percentage of participants|||Number
822636|NCT01164501|Other Pre-specified|Hypoglycaemic Events|Percentage of patients who experienced a hypoglycaemic event. A hypoglycaemic event was regarded as confirmed if it was documented as an adverse event with plasma glucose values <= 70 mg/dL (<=3.9mmol/L) measured or with a documentation that the assistance of another person to actively administer carbohydrate, glucagon or other resuscitative action had been required.|From first drug administration until 7 days after last trial medication intake, up to 458 days|Treated set which included all patients treated with at least one dose of randomised trial medication.||percentage of participants|||Number
822637|NCT01164501|Primary|HbA1c Change From Baseline in Patients With Moderate Renal Impairment|"Change from baseline in HbA1c after 24 weeks, for patients with moderate renal impairment.
Note adjusted means are provided."|Baseline and 24 weeks|Full analysis set (FAS) which included all randomised patients, treated with at least one dose of trial medication, who had a baseline HbA1c value. Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.||percentage of HbA1c||Standard Error|Mean
822638|NCT01164501|Primary|HbA1c Change From Baseline in Patients With Mild Renal Impairment|"Change from baseline in HbA1c after 24 weeks, for patients with mild renal impairment.
Note adjusted means are provided."|Baseline and 24 weeks|Full analysis set (FAS) which included all randomised patients, treated with at least one dose of trial medication, who had a baseline HbA1c value. Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.||percentage of HbA1c||Standard Error|Mean
822639|NCT01164501|Primary|HbA1c Change From Baseline in Patients With Mild or Moderate Renal Impairment|"Change from baseline in HbA1c after 24 weeks, for patients with mild or moderate renal impairment.
Note adjusted means are provided."|Baseline and 24 weeks|Full analysis set (FAS) which included all randomised patients, treated with at least one dose of trial medication, who had a baseline HbA1c value. Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.||percentage of HbA1c||Standard Error|Mean
822640|NCT01164579|Secondary|Percentage of Participants With DAS28-4 (ESR) <2.6|DAS28-4(ESR) was calculated from swollen joint count and tender joint count using 28 joints count, ESR (mm/hour) and Participant's Global Assessment of Disease Activity (participant rated arthritis activity assessment). Total score range: 0 to 9.4, higher score=more disease activity. DAS28-4(ESR) <2.6 implied remission.|Months 1, 2, 3, 6, 9, and 12|FAS NRI; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
822641|NCT01164579|Secondary|Percentage of Participants With DAS28-4 (ESR) â‰¤3.2|DAS28-4(ESR) was calculated from swollen joint count and tender joint count using 28 joints count, ESR (mm/hour) and Participant's Global Assessment of Disease Activity (participant rated arthritis activity assessment). Total score range: 0 to 9.4, higher score=more disease activity. DAS28-4(ESR) â‰¤3.2 implied low disease activity.|Months 1, 2, 3, 6, 9, and 12|FAS NRI; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
822642|NCT01164579|Secondary|Percentage of Participants With DAS28-4 (ESR) Response (Good or Moderate Improvement)|DAS28-4(ESR) was calculated from swollen joint count and tender joint count using 28 joints count, ESR (mm/hour) and Participant's Global Assessment of Disease Activity (participant rated arthritis activity assessment). Total score range: 0 to 9.4, higher score=more disease activity. DAS28 categorical responses define a good (absolute: <3.2 or >1.2 improvement from BL), moderate (absolute: 3.2-5.1 or 0.6-1.2 change from BL), or no response (absolute: >5.1 or <0.6 change from BL).|Months 1, 2, 3, 6, 9, and 12|FAS NRI; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
822643|NCT01164579|Secondary|Percentage of Participants With DAS28-3 (CRP) Score <2.6|DAS28-3(CRP) was calculated from the swollen joint count and tender joint count using 28-joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3(CRP) <2.6 implied remission.|Months 1, 2, 3, 6, 9, and 12|FAS NRI; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
822644|NCT01164579|Secondary|Percentage of Participants With DAS28-3 (CRP) Score â‰¤3.2|DAS28-3(CRP) was calculated from the swollen joint count and tender joint count using 28-joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3(CRP) â‰¤3.2 implied low disease activity.|Months 1, 2, 3, 6, 9, and 12|FAS NRI; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
822645|NCT01164579|Secondary|Percentage of Participants With DAS28-3 (CRP) Response (Good or Moderate Improvement)|DAS28-3(CRP) was calculated from the swollen joint count and tender joint count using 28-joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28 categorical responses define a good (absolute: <3.2 or >1.2 improvement from baseline [BL]), moderate (absolute: 3.2-5.1 or 0.6-1.2 change from BL), or no response (absolute: >5.1 or <0.6 change from BL).|Months 1, 2, 3, 6, 9, and 12|FAS NRI; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
822646|NCT01164579|Secondary|Change From Baseline in DAS28-4 (ESR)|DAS28-4 (ESR) was calculated from swollen joint count and tender joint count using 28 joints count, ESR (millimeters per hour [mm/hour]) and Participant Global Assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to 9.4; higher score=more disease activity.|Months 1, 2, 3, 6, 9, and 12|FAS; n=number of participants assessed for the specified parameter at a given visit.||scores on a scale||Standard Error|Least Squares Mean
822827|NCT01165684|Secondary|Proportion of Subjects Reaching Glycosylated Haemoglobin (HbA1c) Below 7.0% at Week 32|Proportion of subjects reaching HbA1c below 7.0% at Week 32|Week 32|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 383 subjects contributed to the statistical analysis at Week 32.||percentage (%) of subjects|||Number
822647|NCT01164579|Secondary|Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (DAS28-4 [ESR])|DAS28-4 (ESR) was calculated from swollen joint count and tender joint count using 28 joints count, ESR (millimeters per hour [mm/hour]) and Participant Global Assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to 9.4; higher score=more disease activity. DAS28-4 (ESR) â‰¤3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = remission.|Baseline and Months 1, 2, 3, 6, 9, and 12|FAS; n=number of participants assessed for the specified parameter at a given visit.||scores on a scale||Standard Deviation|Mean
822648|NCT01164579|Secondary|Change From Baseline in DAS28-3 (CRP)|DAS28-3 (CRP) was calculated from the swollen joint count and tender joint count using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity.|Months 1, 2, 3, 6, 9, and 12|FAS; n=number of participants assessed for the specified parameter at a given visit.||scores on a scale||Standard Error|Least Squares Mean
822649|NCT01164579|Secondary|Disease Activity Score Based on 28-Joint Count and CRP (DAS28-3 [CRP])|DAS28-3 (CRP) was calculated from the swollen joint count and tender joint count using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) less than or equal to (â‰¤)3.2 implied low disease activity and greater than (>)3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) less than (<)2.6 = remission.|Baseline and Months 1, 2, 3, 6, 9, and 12|FAS; n=number of participants assess for the specified parameter at a given visit.||score on a scale||Standard Deviation|Mean
822650|NCT01164579|Secondary|Percentage of Participants With an ACR 70% Improvement (ACR70) Response|ACR70 response: â‰¥70% improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: 1) Physician's Global Assessment of Disease Activity, 2) Participant's Assessment of Disease Activity, 3) Participant's Assessment of Pain, 4) Participant's Assessment of Functional Disability via a HAQ, and 5) CRP at each visit.|Months 1, 2, 3, 6, 9, and 12|FAS NRI; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
822651|NCT01164579|Secondary|Percentage of Participants With an ACR 50% Improvement (ACR50) Response|ACR50 response: â‰¥ 50% improvement in tender or swollen joint counts and 50% improvement in 3 of the following 5 criteria: 1) Physician's Global Assessment of Disease Activity, 2) Participant's Assessment of disease activity, 3) Paricipant's Assessment of Pain, 4) Participant's assessment of functional disability via a HAQ, and 5) CRP at each visit.|Months 1, 2, 3, 6, 9, and 12|FAS NRI; n=number of participants assess for the specified parameter at a given visit.||percentage of participants|||Number
822652|NCT01164579|Secondary|Percentage of Participants With an American College of Rheumatology (ACR) 20 Percent (%) Improvement (ACR20) Response|ACR20 response: greater than or equal to (â‰¥)20% improvement in tender joint count; â‰¥20% improvement in swollen joint count; and â‰¥20% improvement in at least 3 of 5 remaining ACR core measures: Participant's Assessment of Pain; Participant's Global Assessment of Disease Activity; Physician Global Assessment of Disease Activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Months 1, 2, 3, 6, 9, and 12|FAS Non-Responder Imputation (NRI) method: participants with missing values were considered to be non-responders. n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
822653|NCT01164579|Secondary|Change From Baseline to Months 6 and 12 in Erosion Score|Erosion score (a component of the modified TSS) is a measure of change in joint health. Erosion score range is from 0 (no erosion) to 280 (high erosion). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.|Months 6 and 12|Evaluable Set; n=number of participants assessed for the specified parameter at a given visit.||scores on a scale||Standard Error|Least Squares Mean
822654|NCT01164579|Secondary|Erosion Scores at Months 6 and 12|Erosion score (a component of the modified TSS) is a measure of change in joint health. Erosion score range is from 0 (no erosion) to 280 (high erosion). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.|Months 6 and 12|Evaluable Set; n=number of participants assessed for the specified parameter at a given visit.||scores on a scale||Standard Error|Least Squares Mean
822655|NCT01164579|Secondary|Change From Baseline to Months 6 and 12 in JSN Scores|JSN score (a component of the modified TSS) is a measure of change in joint health. JSN score range is 0 (no narrowing) to 168 (high narrowing). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.|Months 6 and 12|Evaluable Set; n=number of participants assessed for the specified parameter at a given visit.||scores on a scale||Standard Error|Least Squares Mean
822656|NCT01164579|Secondary|Joint Space Narrowing (JSN) Scores at Months 6 and 12|JSN score (a component of the modified TSS) is a measure of change in joint health. JSN score range is 0 (no narrowing) to 168 (high narrowing). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.|Months 6 and 12|Evaluable Set; n=number of participants assessed for the specified parameter at a given visit.||score on a scale||Standard Error|Least Squares Mean
822657|NCT01164579|Secondary|Change From Baseline to Months 6 and 12 in mTSS|Modified TSS is a measure of change in joint health. TSS is defined as joint space narrowing score (range 0 [no narrowing] to 168 [high narrowing]) + erosion score (range is from 0 [no erosion] to 280 [high erosion]). The modified TSS range is from 0 (no damage) to 448 (bad joint status). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.|Months 6 and 12|Evaluable Set; n=number of participants assessed for the specified parameter at a given visit.||scores on a scale||Standard Error|Least Squares Mean
822658|NCT01164579|Secondary|Modified Total Sharp Score (mTSS) at Months 6 and 12|Modified TSS is a measure of change in joint health. TSS is defined as joint space narrowing score (range 0 [no narrowing] to 168 [high narrowing]) plus (+) erosion score (range is from 0 [no erosion] to 280 [high erosion]). The modified TSS range is from 0 (no damage) to 448 (bad joint status). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.|Months 6 and 12|Evaluable Set; n=number of participants assessed for the specified parameter at a given visit.||score on a scale||Standard Error|Least Squares Mean
822659|NCT01164579|Secondary|Change From Baseline to Months 1, 3, 6, and 12 in OMERACT RAMRIS Wrist and MCP Erosions|Bone erosion assessed at 25 anatomic locations: 15 in 1 wrist and 10 in attached hand. Each site was scored in 1.0 increments from 0 (no damage) to 10 (severe damage), indicating erosion (each unit=10% bone loss) of original articular bone. OMERACT RAMRIS total erosion score for hands/wrists was sum of the individual scores for each location. Thus the maximum score per hand/wrist is 250 (range 0-250). Increasing score=greater severity.|Months 1, 3, 6, and 12|Evaluable Set||score on a scale||Standard Error|Least Squares Mean
822660|NCT01164579|Secondary|Change From Baseline to Months 1, 3, and 12 in OMERACT RAMRIS Bone Marrow Edema in Wrist and MCP|Bone edema was assessed at 25 anatomic locations: 15 in 1 wrist and 10 in attached hand. Bone edema was defined as a lesion within the trabecular bone, with ill-defined margins and signal characteristics consistent with increased water content. Each bone was scored separately; the scale was 0â€“3 based on the proportion of bone with edema, as follows 0: no edema; 1: 1â€“33% of bone edematous; 2: 34â€“66% of bone edematous; 3: 67â€“100%. OMERACT RAMRIS total bone edema score for hands/wrists was sum of the individual scores for each location. Thus the maximum score per hand/wrist was 75 (range 0-75). Increasing score=greater severity.|Months 1, 3, and 12|Evaluable Set; n=number of participants assessed for the specified parameter at a given visit.||score on a scale||Standard Error|Least Squares Mean
822661|NCT01164579|Secondary|Change From Baseline to Months 1, 6, and 12 in OMERACT RAMRIS Wrist and MCP Synovitis|Synovitis is defined as an area in the synovial compartment that shows above normal postgadolinium enhancement of a thickness greater than the width of the normal synovium. T1-weighted images were acquired before and after the administration of intravenous contrast agent containing gadolinium. Intravenous contrast was required to demonstrate enhancing synovitis. Synovitis was scored 0 to 3 in 3 wrist regions and in each of the first through fifth MCP joints. A score of 0 is normal, with no enhancement or enhancement up to the thickness of normal synovium, while scores of 1 to 3 (mild, moderate, severe) refer to increments of one-third of the presumed maximum volume of enhancing tissue in the synovial compartment. Total synovitis score ranges from a minimum of 0 to a maximum of 24. A negative value in synovitis change from Baseline score indicates an improvement.|Months 1, 6, and 12|Evaluable Set||score on a scale||Standard Error|Least Squares Mean
822662|NCT01164579|Primary|Change From Baseline to Month 6 in OMERACT RAMRIS Wrist and MCP Bone Marrow Edema|Bone edema was assessed at 25 anatomic locations: 15 in 1 wrist and 10 in attached hand. Bone edema was defined as a lesion within the trabecular bone, with ill-defined margins and signal characteristics consistent with increased water content. Each bone was scored separately; the scale was 0-3 based on the proportion of bone with edema, as follows 0: no edema; 1: 1-33% of bone edematous; 2: 34-66% of bone edematous; 3: 67-100%. OMERACT RAMRIS total bone edema score for hands/wrists was sum of the individual scores for each location. Thus the maximum score per hand/wrist was 75 (range 0-75). Increasing score=greater severity.|Month 6|Evaluable Set||score on a scale||Standard Error|Least Squares Mean
822663|NCT01164579|Primary|Change From Baseline to Month 3 in Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Imaging Score (RAMRIS) Wrist and Metacarpophalangeal (MCP) Synovitis|Synovitis is defined as an area in the synovial compartment that shows above normal postgadolinium enhancement of a thickness greater than the width of the normal synovium. T1-weighted images were acquired before and after the administration of intravenous contrast agent containing gadolinium. Intravenous contrast was required to demonstrate enhancing synovitis. Synovitis was scored 0 to 3 in 3 wrist regions and in each of the first through fifth MCP joints. A score of 0 is normal, with no enhancement or enhancement up to the thickness of normal synovium, while scores of 1 to 3 (mild, moderate, severe) refer to increments of one-third of the presumed maximum volume of enhancing tissue in the synovial compartment. Total synovitis score ranges from a minimum of 0 to a maximum of 24. A negative value in synovitis change from Baseline score indicates an improvement.|Month 3|Evaluable Set: all randomized participants who received at least 1 dose of the randomized investigational drug and for whom a variable is nonmissing at both baseline and the specified timepoint.||score on a scale||Standard Error|Least Squares Mean
822664|NCT01164644|Primary|Assess Extent of Bruising|Primary outcome measure will be to measure the extent of bruising based on a ratio of pixels on post-operative day number ten. Every subject held a card in front of their face with a specific size marker. The square area of this marker was known and used to measure the number of pixels in this marker with Photoshop and compare it to the known area. Next the area of bruising was measured in number of pixels. Therefore for every photograph a standardized ratio of pixels was known because of the marker.|Post-operative day 10|||a ratio of pixels||Standard Error|Mean
822665|NCT01164644|Primary|Assess Extent of Bruising|Primary outcome measure will be to measure the extent of bruising based on a ratio of pixels on post-operative day number seven. Every subject held a card in front of their face with a specific size marker. The square area of this marker was known and used to measure the number of pixels in this marker with Photoshop and compare it to the known area. Next the area of bruising was measured in number of pixels. Therefore for every photograph a standardized ratio of pixels was known because of the marker.|Post-operative day 7|||a ratio of pixels||Standard Error|Mean
822666|NCT01164644|Primary|Assess Extent of Bruising|Primary outcome measure will be to measure the extent of bruising in based on a ratio of pixels on post-operative day number three. Every subject held a card in front of their face with a specific size marker. The square area of this marker was known and used to measure the number of pixels in this marker with Photoshop and compare it to the known area. Next the area of bruising was measured in number of pixels. Therefore for every photograph a standardized ratio of pixels was known because of the marker. The ratio was calculated by dividing the number of pixels of bruised area over number of pixels of standard area.|Post-operative day 3|||a ratio of pixels||Standard Error|Mean
822667|NCT01164722|Secondary|Incidence of Metachronous Lesions|Number of patients with one or more metachronous lesions|one year on study|Patents with any biopsy from randomization to one year||Participants|||Count of Participants
822668|NCT01164722|Secondary|Recurrence Rate at 1 Year||1 year on study|Patients who were treated with IRC, no data were collected on patients on the expectant management arm||Percentage of lesions that recurred|||Number
822669|NCT01164722|Secondary|Proportion of Patients With High-grade Anal Intraepithelial Neoplasia at 1 Year|Number of patients who had high grade anal intraepithelial neoplasia at one year.|1 year on study|Patients who had an evaluable biopsy within one year after randomization.||Participants|||Count of Participants
822672|NCT01164865|Primary|Likert Questionnaire Scores at 2 Weeks|The Likert Questionnaire included 8 questions on selected comfort measures. All responses were recorded on a 5-point scale, where 1=Strongly Disagree, 2=Disagree, 3=Undecided, 4=Agree, and 5=Strongly Agree.|2 weeks|All participants who received regimen, satisfied the inclusion/exclusion criteria, and completed the 14-day treatment period, including completion of the Visit 2 evaluations.||Units on a scale||95% Confidence Interval|Least Squares Mean
822673|NCT01164865|Primary|Change From Baseline in Ocular Comfort Rating at 2 Weeks|"Ocular comfort was rated by the participant on a continuous visual analog scale from 0-100, where 0=extremely uncomfortable, 50=neither comfortable nor uncomfortable, and 100=extremely comfortable. The participant marked a horizontal line across the scale at the point that best described how your eyes feel right now."|Baseline (Day 0), 2 weeks|All participants who received regimen, satisfied the inclusion/exclusion criteria, and completed the 14-day treatment period, including completion of the Visit 2 evaluations.||Units on a scale||95% Confidence Interval|Least Squares Mean
822674|NCT01164891|Primary|Percentage of Total Dose in 14C-labeled RO5185426 and 14C-labeled Metabolite in Pooled Urine Samples|Collection of samples continued until the recovery criterion was met (radioactivity recovered from urine and feces ≤ 1 % of the radioactivity in the administered dose between any two successive 48-hour interval assessments). Urine samples were pooled over period of 96 hours (pool of 0-6 + 6-12 + 12-24 + 24-48 + 48-72 + 72-96 hour samples). Data for parent drug (RO5185426) and metabolites (2 unknown metabolites, glucosylation, mono-hydroxy) are reported.|0 up to 96 hours post dose on Day 15|PK Analysis Population.||percentage of total dose administered||Standard Deviation|Mean
822675|NCT01164891|Primary|Percentage of Total Integrated Radioactivity in Urine of 14C-labeled RO5185426 and 14C-labeled Metabolite|Collection of samples continued until the recovery criterion was met (radioactivity recovered from urine and feces ≤ 1 % of the radioactivity in the administered dose between any two successive 48-hour interval assessments). Urine samples were pooled over period of 96 hours (pool of 0-6 + 6-12 + 12-24 + 24-48 + 48-72 + 72-96 hour samples), Radioactivity was measured in terms of region of interest by high performance liquid chromatography. The radiolabelled components in each chromatogram were evaluated to determine retention times and peak area values. Data for 14C-labeled RO5185426 and 14C-labeled metabolites (2 unknown metabolites, glucosylation, mono-hydroxy) are reported.|0 up to 96 hours post dose on Day 15|PK Analysis Population.||percentage of total radioactivity||Standard Deviation|Mean
822676|NCT01164891|Primary|Percentage of Total Dose in 14C-labeled RO5185426 and 14C-labeled Metabolite in Pooled Fecal Samples|Collection of samples continued until the recovery criterion was met (radioactivity recovered from urine and feces ≤ 1 % of the radioactivity in the administered dose between any two successive 48-hour interval assessments). Fecal samples were pooled over 2 time intervals (0-24 + 24-48 hours, 48-72 + 72-96 hours) for measurement of 14C-labeled RO5185426 and 14C-labeled metabolites (glucosylation, mono-hydroxy, glucuronide) levels.|0-24 + 24-48 hours, 48-72 + 72-96 hours post dose on Day 15|PK Analysis Population.||percentage of total dose administered||Standard Deviation|Mean
822677|NCT01164891|Primary|Percentage of Total Integrated Radioactivity in Feces of 14C-labeled RO5185426 and 14C-labeled Metabolite|Collection of samples continued until the recovery criterion was met (radioactivity recovered from urine and feces ≤ 1 % of the radioactivity in the administered dose between any two successive 48-hour interval assessments). Fecal samples were pooled over two time intervals for this analysis (0-24 + 24-48 hours, 48-72 + 72-96 hours). Radioactivity was measured in terms of region of interest by high performance liquid chromatography. The radiolabelled components in each chromatogram were evaluated to determine retention times and peak area values. Data for 14C-labeled RO5185426 and 14C-labeled metabolites (glucosylation, mono-hydroxy, and glucuronide) are reported.|0-24 + 24-48 hours, 48-72 + 72-96 hours post dose on Day 15|PK Analysis Population.||percentage of total radioactivity||Standard Deviation|Mean
822678|NCT01164891|Primary|Plasma 14C-labeled RO5185426 and 14C-labeled Metabolite Levels|Collection of samples for radioactivity continued until the recovery criterion was met (radioactivity recovered from urine and feces ≤ 1 % of the radioactivity in the administered dose between any two successive 48 hour interval assessments). Plasma samples were pooled over three time intervals for this analysis based on available radioactive counts (4 + 6 hours, 12 + 24 hours, and 36 + 48 hours). The concentrations were measured in nanogram equivalent per gram which was calculated based on ratio of dosed radioactivity and the last dose of RO5185426. The concentration values represented the drug portion of the last dose. Data for 14C-labeled RO5185426 and 14C-labeled metabolite (mono-hydroxy) are reported.|4+6 hours, 12 +24 hours, 36+48 hours post dose on Day 15|PK Analysis Population.||nanogram equivalent per gram||Standard Deviation|Mean
822679|NCT01164891|Primary|Percentage of Total Integrated Radioactivity in Plasma of 14C-labeled RO5185426 and 14C-labeled Metabolite|Collection of samples continued until the recovery criterion was met (radioactivity recovered from urine and feces ≤ 1 % of the radioactivity in the administered dose between any two successive 48-hour interval assessments). Plasma samples were pooled over three time intervals for this analysis based on available radioactive counts (4 + 6 hours, 12 + 24 hours, and 36 + 48 hours). Radioactivity was measured in terms of region of interest by high performance liquid chromatography. The radiolabelled components in each chromatogram were evaluated to determine retention times and peak area values. Data for 14C-labeled RO5185426 and 14C-labeled metabolite (mono-hydroxy) are reported.|4+6 hours, 12 +24 hours, 36+48 hours post dose on Day 15|PK Analysis Population.||percentage of total radioactivity||Standard Deviation|Mean
822680|NCT01164891|Primary|14C-labeled RO5185426 Recovery: Percentage of Dose Excreted in Feces and Urine|Urinary and fecal samples were analyze for the percentage dose recovered as total radioactivity. The radioactivity was determined on a Packard liquid scintillation counter. Collection of samples continued until the recovery criterion was met (radioactivity recovered from urine and feces ≤ 1 % of the radioactivity in the administered dose between any two successive 48-hour interval assessments).|Urine:0 hour (pre dose),in quantitative fraction(0-6,6-12,12-24 hours) post dose on Day 15,during 24 hour interval thereafter;Feces:From Day 14 upto pre dose on Day 15,during 24 hour interval post dose until recovery criterion;(maximum:432 hours for both)|PK Analysis Population. One participant was excluded in the analysis because of contamination of urine sample with feces.||percentage of dose recovered||Standard Deviation|Mean
822828|NCT01165684|Secondary|Proportion of Subjects Reaching Glycosylated Haemoglobin (HbA1c) Below 7.0% at Week 21|Proportion of subjects reaching HbA1c below 7.0% at Week 21|Week 21|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 383 subjects contributed to the statistical analysis at Week 21.||percentage (%) of subjects|||Number
822681|NCT01164891|Primary|AUC Ratio of Blood:Plasma 14C-labeled RO5185426|Collection of samples continued until the recovery criterion was met (radioactivity recovered from urine and feces ≤ 1 % of the radioactivity in the administered dose between any two successive 48-hour interval assessments).|0 hour (prior to evening dose) on Day 14; 0 hour (pre dose), 1, 2, 4, 6, 12, 24, 36, 48, 72, 96, 168, 216, 312 hours post dose on Day 15, and then every 96 hour until recovery criteria met (maximum: 432 hours)|PK Analysis Population. Number of participants analysed = participants with measurable data for this outcome.||ratio||Standard Deviation|Mean
822682|NCT01164891|Primary|Half-life of 14C-labeled RO5185426 in Both Blood and Plasma|Collection of samples continued until the recovery criterion was met (radioactivity recovered from urine and feces ≤ 1 % of the radioactivity in the administered dose between any two successive 48-hour interval assessments).|0 hour (prior to evening dose) on Day 14; 0 hour (pre dose), 1, 2, 4, 6, 12, 24, 36, 48, 72, 96, 168, 216, 312 hours post dose on Day 15, and then every 96 hour until recovery criteria met (maximum: 432 hours)|PK Analysis Population. Number of participants analyzed = participants with measurable data for this outcome.||hour||Standard Deviation|Mean
822683|NCT01164891|Primary|Area Under the Plasma Concentration Time Curve From Time Zero to the Last Quantifiable Sample (AUClast) of 14C-RO5185426 in Both Blood and Plasma|Collection of samples continued until the recovery criterion was met (radioactivity recovered from urine and feces ≤ 1 % of the radioactivity in the administered dose between any two successive 48-hour interval assessments). 14C-labeled RO5185426 given was equivalent to ≤1mSv.|0 hour (prior to evening dose) on Day 14; 0 hour (pre dose), 1, 2, 4, 6, 12, 24, 36, 48, 72, 96, 168, 216, 312 hours post dose on Day 15, and then every 96 hour until recovery criteria met (maximum: 432 hours)|PK Analysis Population. Number of participants analyzed = participants with measurable data for this outcome.||(micrograms equivalent/milliliter)*hour||Standard Deviation|Mean
822684|NCT01164891|Primary|Time to Reach Cmax in Both Blood and Plasma|Collection of samples continued until the recovery criterion was met (radioactivity recovered from urine and feces ≤ 1 % of the radioactivity in the administered dose between any two successive 48-hour interval assessments).|0 hour (prior to evening dose) on Day 14; 0 hour (pre dose), 1, 2, 4, 6, 12, 24, 36, 48, 72, 96, 168, 216, 312 hours post dose on Day 15, and then every 96 hour until recovery criteria met (maximum: 432 hours)|PK Analysis Population. Number of participants analyzed = participants with measurable data for this outcome.||hours||Full Range|Median
822685|NCT01164891|Primary|Maximum Plasma Concentration of 14C-labeled RO5185426 (Cmax) in Both Blood and Plasma|Collection of samples continued until the recovery criterion was met (radioactivity recovered from urine and feces ≤ 1 % of the radioactivity in the administered dose between any two successive 48-hour interval assessments). 14C-labeled RO5185426 given was equivalent to ≤1 millisieverts (mSv).|0 hour (prior to evening dose) on Day 14; 0 hour (pre dose), 1, 2, 4, 6, 12, 24, 36, 48, 72, 96, 168, 216, 312 hours post dose on Day 15, and then every 96 hour until recovery criteria met (maximum: 432 hours)|PK Analysis Population. Number of participants analyzed = participants with measurable data for this outcome.||micrograms equivalent per milliliter||Standard Deviation|Mean
822686|NCT01164891|Secondary|Overall Survival|Overall survival was defined as the time from the date of first treatment to the date of death, regardless of the cause of death.|From Baseline then Day 1 of Cycle 3 thereafter, Day 1 of every other cycle (every 2 months) until death (maximum 841 days)|The data was not collected, as planned, due to small number of participants enrolled in the study.|||||
822687|NCT01164891|Secondary|Number of Participants With a Response by Confirmed Best Overall Response|Best overall response (according to Response Evaluation Criteria In Solid Tumors 1.1 criteria) was defined as best response recorded from start of treatment until disease progression which included complete response (CR) or partial response (PR) that had been confirmed by second tumor assessment no less than (<) 4 weeks after criteria for response were first met. Confirmed CR: disappearance of all target and non-target lesions; no new lesions, and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 millimeters (mm). Confirmed PR: at least 30% decrease in sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Disease progression: at least 20% increase in sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.|From Baseline then Day 1 of Cycle 3 thereafter, Day 1 of every other cycle (every 2 months) until disease progression, withdrawal from study or death (maximum 841 days)|Safety population included all participants who received at least 1 dose of study drug.||participants|||Number
822688|NCT01164891|Primary|Plasma RO5185426 Trough Concentrations on Days 15,16, and 17||Pre-dose on Days 15, 16 and 17|Pharmacokinetic (PK) Analysis Population: participants from whom the level of radioactivity recovered from excreta (urine and feces) was ≤ 1% of the radioactivity in the administered dose between any two successive 48-hour interval assessments.||micrograms per milliliter||Standard Deviation|Mean
822689|NCT01165021|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time from date of first dose to the first observation of disease progression or death due to any cause. For participants not known to have died or did not have objective progressive disease (PD) as of the data inclusion cut-off date, PFS was censored at the date of the last objective progression-free disease assessment. PD was defined using RECIST v1.1 criteria as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (including the baseline sum if that is the smallest). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.|Enrollment until the first date of objectively determined PD or death up to 64 months|All participants who received 1 or more doses of preoperative chemotherapy. Participants censored=3.||months||95% Confidence Interval|Median
822690|NCT01165021|Secondary|Overall Survival (OS)|OS was defined as duration from the date of study enrollment to the date of death from any cause. Participants not known to have died as of the data inclusion cut-off date were censored at the date of last contact. The last contact for participants in post-discontinuation was the last date participant was known to be alive.|Enrollment until the date of death from any cause up to 64 months|All participants who received 1 or more doses of preoperative chemotherapy. Participants censored=8||months||95% Confidence Interval|Median
822881|NCT01159262|Primary|Percentage of Subjects Who Received Rescue Medication Midazolam for Sedation During Dexmedetomidine Infusion||During study drug administration (6 to 24 hours)|Efficacy Evaluable Population: All subjects who received randomized Dexmedetomidine for at least 6 hours.||percentage of subjects|||Number
822691|NCT01165021|Secondary|Percentage of Participants Who Exhibit a Downward Shift in Tumor Extent From Stage IIIAN2 to Stages IIIA, II, I, or Stage 0|Tumor downstaging compared to baseline (Stage IIIAN2) were those participants who exhibited a downward shift in tumor extent from Stage IIIAN2 to Stages IIIA, II, I, or 0 were reported. Downstaging was based on radiological examination. Stage IIIAN2 was locally advanced and/or involved lymph nodes, metastasis in ipsilateral mediastinal and or subcarinal lymph nodes, tumors were ≤2 centimeters (cm) up to 5 cm in greatest dimension; Stage IIIA was locally advanced and/or involved lymph nodes, tumor extension was restricted to the affected lung; Stage II was locally advanced and/or involved lymph nodes; Stage I was small localized cancers, usually curable; Stage 0 the cancer did not spread beyond the inner lining of the lung. Missing responses were also reported. Percentage of participants calculated as: (number of participants with a downward shift in extent of their tumor) divided by (total number of evaluable participants) multiplied by 100.|From study enrollment until disease progression or recurrence up to completion of 3 cycles (21-day cycles) of chemotherapy|Participants who received at least 1 dose of preoperative chemotherapy and had baseline and Cycle 3 scans for tumor assessment.||percentage of participants||95% Confidence Interval|Number
822692|NCT01165021|Secondary|Percentage of Participants With No Viable Tumor Cells in Resected Lung Tissue [Pathological Complete Remission (pCR)]|pCR after the participant has undergone surgery was calculated as: (total number of participants with pCR) divided by (the total number of participants in pathological response population) multiplied by 100.|At the time of surgery (within 3 to 6 weeks of Day 1 of Cycle 3 [21-day cycles] of chemotherapy)|Participants who received at least 1 dose of preoperative chemotherapy and had surgical tumor tissue samples available.||percentage of participants||95% Confidence Interval|Number
822693|NCT01165021|Primary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)]|Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST v1.1) criteria. CR was defined as the disappearance of all target and non-target lesions and all target and non-target lymph nodes were non-pathological or normal in size [<10 millimeter (mm) short axis]. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions taking as reference the baseline sum diameters. ORR calculated as: (sum of the number of participants with PRs and CRs) divided by (number of evaluable participants) multiplied by 100.|From study enrollment until disease progression or recurrence up to completion of 3 cycles (21-day cycles) of chemotherapy|Participants who received at least 1 dose of preoperative chemotherapy and had baseline and Cycle 3 scans for tumor assessment.||percentage of participants||95% Confidence Interval|Number
822694|NCT01165047|Primary|Number of Participants With Side Effects and/or Adverse Events|A phone contact will be made to the subject 5 days after the trial to assess general health status and collect information on any reported side effects or adverse events.|5 days|||participants|||Number
822695|NCT01165112|Secondary|Ability to Proceed to Peripheral Blood Stem Cell (PBSC) Collection Following Treatment (Impact of This Regimen on Stem Cell Reserve)||Up to 5 weeks after the last course|||Participants|||Count of Participants
822696|NCT01165112|Secondary|Preliminary Assessment of the Efficacy of This Regimen|Response will be defined by standard NCI criteria (Cheson et al) for lymphoid malignancies.|Up to 5 weeks after the last course|||Participants|||Count of Participants
822697|NCT01165112|Primary|Safety and Toxicity of This Regimen|Count of participants experiencing a dose limiting toxicity. The National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0 will be used to classify and grade toxicities.|Up to 5 weeks after the last course|||Participants|||Count of Participants
822698|NCT01165112|Primary|Maximally Tolerated Dose of Bendamustine Hydrochloride That Can be Combined With Rituximab, Carboplatin, and Etoposide Chemotherapy in Patients With Relapsed or Refractory Lymphoid Malignancies|Defined as dose at which approximately =< 25% of patients experience a DLT. Following completed observation of final patient, two-parameter logistic model fit to data, generating dose-response curve based on observed toxicity rate at dose levels visited. Based on this fitted model, MTD is estimated to be dose that is associated with toxicity rate of 25%. If estimate of slope parameter for fitted curve is not positive and finite, geometric mean of dose level used for last cohort and dose level that would have been assigned to next cohort is taken as MTD.|Up to 5 weeks after the last course|||mg/m2 x 2|||Number
822699|NCT01165138|Other Pre-specified|Number of Participants With the Indicated Reason for Incorrect Inhaler Use and Who Required Additional Instruction the Indicated Number of Times at Baseline, Week 2, and Week 4|Participants were given a demonstration of correct inhaler use (using placebo inhalers), and the participants' competence to correctly use the demonstration inhaler was then assessed based on 3 steps: open the device, inhale the dose, and close the device. If the participants did not perform the maneuvers correctly, the step of the inhaler use that was performed incorrectly by the participants was recorded. The entire procedure was demonstrated once again. and the number of times that the participants required additional instruction (RAI) was recorded.|Baseline, Week 2, and Week 4|ITT Population. Only those participants who used the inhaler incorrectly at the specified time points were analyzed.||participants|||Number
822700|NCT01165138|Other Pre-specified|Number of Participants Who Used the Inhaler Correctly or Incorrectly at Baseline, Week 2, and Week 4|Participants were given a demonstration of correct inhaler use (using placebo inhalers), and the participants' competence to correctly use the demonstration inhaler was then assessed.|Baseline (BL), Week 2 (W2), and Week 4 (W4)|ITT Population. Only those participants available at the specified time points were analyzed.||participants|||Number
822701|NCT01165138|Other Pre-specified|Number of the Indicated Unscheduled Asthma-related Healthcare Visits During the Treatment Period|All unscheduled asthma-related visits to a physician’s office, visits to urgent care, visits to the emergency department, and hospitalizations (ICU=intensive care unit; GW=general ward) associated with severe asthma exacerbations or other asthma-related healthcare were recorded.|From Baseline up to Week 12/Early Withdrawal|ITT Population||Number of visits||Standard Deviation|Mean
822717|NCT01165177|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Occurrence and relationship to vaccination of all SAEs in all subjects. Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Within the 30-day (Days 0-29) post-vaccination period, up to Month 14 and up to study end (3 to 5 year period following Day 0)|This analysis was based on the the total vaccinated cohort, which included all subjects with at least one dose of study vaccine or placebo administered.||Subjects|||Number
822702|NCT01165138|Other Pre-specified|Number of Participants With the Indicated Global Assessment of Change Responses at Week 4, Week 8, and Week 12/Early Withdrawal|At the end of Week 4, Week 8, and Week 12/Early Withdrawal, the Global Assessment of Change Questionnaire that assesses changes in asthma symptoms (AS) and rescue medication use (RMU) was completed by the participants. The number of participants who chose the following answers to the questionnaire were determined: much better, somewhat better, a little better, the same, a little worse, somewhat worse, much worse (to assess the changes in asthma symptom); much less often , somewhat less often , a little less often , the same , a little more often , somewhat more often , much more often (to assess the changes in the frequency of rescue medication use).|Week 4, Week 8, and Week 12/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed.||participants|||Number
822703|NCT01165138|Other Pre-specified|Change From Baseline in the Asthma Control Test (ACT) Score at Week 12|"The ACT is a 5-item questionnaire developed as a measure of the participant's asthma control. Questions are designed to be self-completed by the participant and include the following: In the past 4 weeks, How much of the time did your asthma keep you from getting as much done at work, school or at home?, How often have you had shortness of breath?, How often did your asthma symptoms wake you up at night or earlier than usual in the morning?, How often have you used your rescue inhaler or nebulizer medication (such as albuterol)? and How would you rate your asthma control? The ACT total score is defined as the sum of the scores from all 5 questions, provided all questions have been answered; thus, the total score ranges from 5 (poor control of asthma) to 25 (complete control of asthma). A score of 20 or higher indicates well-controlled asthma. Change from Baseline was calculated as the total score at Week 12/Early Withdrawal minus the total score at Baseline."|Baseline and Week 12/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed. The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment group.||Scores on a scale||Standard Error|Least Squares Mean
822704|NCT01165138|Other Pre-specified|Mean Change From Baseline in Daily Evening (PM) PEF Averaged Over the 12-week Treatment Period|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline (defined as the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily PM PEF over the 12-week treatment period (at Week 12) minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment group.|From Baseline up to Week 12|ITT Population. Only those participants available at the specified time points were analyzed.||Liters per minute||Standard Error|Least Squares Mean
822705|NCT01165138|Other Pre-specified|Mean Change From Baseline in Daily Morning (AM) Peak Expiratory Flow (PEF) Averaged Over the 12-week Treatment Period|Peak Expiratory Flow (PEF) is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline (defined as the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily AM PEF over the 12-week treatment period (at Week 12) minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment group.|From Baseline up to Week 12|ITT Population. Only those participants available at the specified time points were analyzed.||Liters per minute||Standard Error|Least Squares Mean
822706|NCT01165138|Other Pre-specified|Number of Participants With Bronchodilator Effect|Bronchodilator effect is defined as an increase of FEV1 (defined as the maximal amount of air that can be forcefully exhaled in one second) from Baseline of both 12% and 200 milliliters (mL) during 24 hours, which was evaluated using the serial FEV1 measurements at Baseline (Visit 3).|Baseline|ITT Population. Only the subset of participants performing serial measurements were analyzed.||participants|||Number
822707|NCT01165138|Other Pre-specified|Weighted Mean Serial FEV1 Over 0-4 Hours Post-dose at Baseline and Week 12|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Serial FEV1 measurements were taken electronically by spirometry at the Baseline and Week 12 clinic visits. Weighted mean serial FEV1 over 0-4 hours was calculated using the serial FEV1 measurements that included the pre-dose assessment (within 30 minutes prior to dosing at Baseline and within 5 minutes prior to dosing at Week 12) and post-dose assessments after 5, 15, and 30 minutes and 1, 2, 3, and 4 hours. At each time point, the highest of 3 technically acceptable measurements were recorded. Baseline was the value obtained at Visit 3.|Baseline and Week 12|ITT Population. Weighted mean serial FEV1 was calculated in the subset of participants for whom serial FEV1 at Week 12 was performed. Only those participants available at the specified time points were analyzed.||Liters||Standard Deviation|Mean
822708|NCT01165138|Other Pre-specified|Weighted Mean Serial FEV1 Over 0-24 Hours Post-dose at Baseline|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Serial FEV1 measurements were taken electronically by spirometry at Baseline. Weighted mean was calculated using the 24-hour serial FEV1 measurements that included the pre-dose assessment (within 30 minutes prior to dosing) and post-dose assessments after 5, 15, and 30 minutes and 1, 2, 3, 4, 5, 12, 16, 20, 23, and 24 hours. At each time point, the highest of 3 technically acceptable measurements were recorded. Baseline was the value obtained at Visit 3.|Baseline|ITT Population. Weighted mean serial FEV1 was calculated in the subset of participants for whom serial FEV1 was performed.||Liters||Standard Deviation|Mean
822709|NCT01165138|Other Pre-specified|Clinic Visit 12-hour Post-dose FEV1 at Week 12|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. 12-hour post-dose FEV1 measurements were taken electronically by spirometry at the Week 12 clinic visit. The highest of 3 technically acceptable measurements was recorded. The analysis was performed using an ANCOVA model with covariates of Baseline FEV1, region, sex, age, and treatment group.|Week 12|ITT Population. 12-hour post-dose FEV1 was analyzed in the subset of participants for whom serial FEV1 at Week 12 was performed.||Liters||Standard Error|Least Squares Mean
822773|NCT01165242|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Month 0 through Month 6|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Participants|||Count of Participants
822710|NCT01165138|Secondary|Serial FEV1 Over 0-1 Hour Post-dose at Randomization|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Serial FEV1 measurements were taken electronically by spirometry at Randomization. Serial FEV1 measurements after 5, 15, and 30 minutes and 1 hour post-dose were assessed. At each time point, the highest of 3 technically acceptable measurements was recorded. The analysis was performed using a repeated measures model adjusted for baseline, region, sex, age, treatment group, and planned time points.|Randomization|ITT Population. Serial FEV1 was calculated for the subset of participants for whom serial FEV1 was performed. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed||Liters||Standard Error|Least Squares Mean
822711|NCT01165138|Secondary|Number of Participants Who Withdrew Due to Lack of Efficacy During the 12-week Treatment Period|The number of participants whose primary reason for withdrawal was lack of efficacy was analyzed.|From the first dose of the study medication up to Week 12/Early Withdrawal|ITT Population||participants|||Number
822712|NCT01165138|Secondary|Change From Baseline in the Total Asthma Quality of Life Questionnaire (AQLQ) (+12) Score at Week 12/Early Withdrawal|"The AQLQ is a disease-specific, self-administered quality of life questionnaire used to evaluate the impact of asthma treatments on the quality of life of asthma sufferers. The AQLQ for 12 years and older (AQLQ [+12]) is a modified version of the AQLQ for use in asthma patients between the age of 12 and 70. The AQLQ contains 32 items in 4 domains: activity limitation (11 items), symptoms (12 items), emotional function (5 items), and environmental stimuli (4 items). For the 32 items on the questionnaire, the response format consists of a seven-point scale, where a value of 1 indicates “total impairment” and a value of 7 indicates “no impairment.” The AQLQ total score is defined as the average of the scores from all 32 questions; thus, the total score ranges from 1 (indicates total impairment) to 7 (indicates no impairment). Baseline was the total score obtained at Visit 3. Change from Baseline was calculated as the total score at Week 12 minus the total score at Baseline."|Baseline and Week 12/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed. The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment group.||Score on a scale||Standard Error|Least Squares Mean
822713|NCT01165138|Secondary|Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 12-week Treatment Period|Asthma symptoms were recorded in a daily eDairy by the participants every day in the morning and evening before taking any rescue or study medication and before the peak expiratory flow measurement. A 24-hour (hr) period in which a participant’s responses to both the morning and evening assessments indicated no symptoms was considered to be symptom free. The Baseline value was derived from the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 12-week Treatment Period minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment group.|Baseline and Week 12|ITT Population. Only those participants available at the specified time points were analyzed.||Percentage of symptom-free 24-hr periods||Standard Error|Least Squares Mean
822714|NCT01165138|Secondary|Mean Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods During the 12-week Treatment Period|The number of inhalations of rescue albuterol/salbutamol inhalation aerosol used during the day and night was recorded by the participants in a daily electronic diary (eDiary). A 24-hour (hr) period in which a participant’s responses to both the morning and evening assessments indicated no use of rescue medication was considered to be rescue free. The Baseline value was derived from the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 12-week Treatment Period minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment group.|Baseline and Week 12|ITT Population. Only those participants available at the specified time points were analyzed.||Percentage of rescue-free 24-hr periods||Standard Error|Least Squares Mean
822715|NCT01165138|Primary|Change From Baseline in Weighted Mean Serial FEV1 Over 0-24 Hours Post-dose at Week 12|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Serial FEV1 measurements were taken electronically by spirometry at the Baseline and Week 12 clinic visits. Weighted mean was calculated using the 24-hour serial FEV1 measurements that included the pre-dose assessment (within 30 minutes prior to dosing at Baseline and within 5 minutes prior to dosing at Week 12) and post-dose assessments after 5, 15, and 30 minutes and 1, 2, 3, 4, 5, 12, 16, 20, 23, and 24 hours. At each time point, the highest of 3 technically acceptable measurements was recorded. Baseline was the value obtained at Visit 3. Change from Baseline was calculated as the average Week 12 FEV1 value minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline FEV1, region, sex, age, and treatment group.|Baseline and Week 12|ITT Population. Weighted mean serial FEV1 was calculated for the subset of participants for whom serial FEV1 was performed at Week 12.||Liters||Standard Error|Least Squares Mean
822716|NCT01165138|Primary|Mean Change From Baseline in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at Week 12|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is defined as the clinic visit (pre-bronchodilator and pre-dose) FEV1measurement taken at the clinic visit while still on-treatment. Pre-dose and pre-rescue albuterol/salbutamol trough FEV1 was measured electronically by spirometry in the evening at the Baseline through Week 12 clinic visits. The highest of 3 technically acceptable measurements was recorded. Baseline was the pre-dose value obtained at Visit 3. Change from Baseline was calculated as the Week 12 value minus the Baseline value. The analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of Baseline trough FEV1, region, sex, age, and treatment group. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement at scheduled clinic visits was used to impute the missing m|Baseline and Week 12|Intent-to-Treat (ITT) Population: all participants randomized to treatment, who received at least one dose of the study medication. Only those participants with non-missing covariates and post-Baseline FEV1 data were analyzed.||Liters||Standard Error|Least Squares Mean
824621|NCT01183013|Secondary|Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 30 Weeks of Treatment)|Glycosylated hemoglobin is reported as a percentage of the total hemoglobin.|Baseline and 30 weeks|FAS with non-completers (without a value at Week 30) considered as failure||participants|||Number
822718|NCT01165177|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|Occurrence, intensity and relationship to vaccination of unsolicited AEs, according to the Medical Dictionary for Regulatory Activities (MedDRA) classification in all subjects An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|Within 30 days (Days 0 - 29) after each vaccination|This analysis was based on the the total vaccinated cohort, which included all subjects with at least one dose of study vaccine or placebo administered.||Subjects|||Number
822719|NCT01165177|Secondary|Number of Subjects With AEs With Any and Related Medically Attended Visit (MAEs)|Occurrence and relationship to vaccination of medically attended visits (defined as hospitalizations, emergency room visits or visits to or from medical personnel), other than routine health care visits in all subjects.|From Month 0 to Month 8 post-vaccination|This analysis was based on the the total vaccinated cohort, which included all subjects with at least one dose of study vaccine or placebo administered.||Subjects|||Number
822720|NCT01165177|Secondary|Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs)|Occurrence and relationship to vaccination of any potential immune-mediated diseases (pIMDs) in all subjects|During the entire study period (3 to 5 year period following Day 0)|This analysis was based on the the total vaccinated cohort, which included all subjects with at least one dose of study vaccine or placebo administered.||Subjects|||Number
822721|NCT01165177|Secondary|Number of Subjects With Any and Grade 3 Symptoms (Solicited and Unsolicited)||Within the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the total vaccinated cohort – Diary Card, which was a subset of subjects from the total vaccinated cohort, who completed diary cards with any solicited symptoms during the 7 days (Day 0 to Day 6) post vaccination period.||Subjects|||Number
822722|NCT01165177|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, fever [defined as oral, axillary, rectal or tympanic temperature equal to or above 37.5 degrees Celsius (°C)], headache, myalgia, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|Within the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the TVc – Diary Card, which was a subset of subjects from the TVc, who completed diary cards with any solicited symptoms during the 7 days (Day 0 to Day 6) post vaccination period.||Subjects|||Number
822723|NCT01165177|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Relationship analysis was not performed.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the total vaccinated cohort – Diary Card, which was a subset of subjects from the total vaccinated cohort, who completed diary cards with any solicited symptoms during the 7 days (Day 0 to Day 6) post vaccination period.||Subjects|||Number
822724|NCT01165177|Secondary|Number of Days of Pain Medication Associated With HZ|The analysis was performed in subjects with a confirmed HZ episode|During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.||Days||Standard Deviation|Mean
822725|NCT01165177|Secondary|Distribution of Pain Medication Associated With HZ|The distribution of pain medication included 1 to 3 or more separate medications. This Outcome Measure was only assessed participants with confirmed HZ.|During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.||Subjects|||Number
822726|NCT01165177|Secondary|Number of Subjects With HZ Related Complications, by Complication Type|Complication types included HZ vasculitis, Disseminated Disease, Ophtalmic Disease, Neurologic Disease, Visceral Disease and Stroke. This Outcome Measure was only assessed participants with confirmed HZ.|During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.||Subjects|||Number
822727|NCT01165177|Secondary|Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations|The analysis focused on confirmed HZ episode related hospitalizations and deaths.|During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.||Subjects|||Number
822728|NCT01165177|Secondary|Number of Days With Severe ‘Worst’ HZ-associated Pain.|Severe 'worst' pain was defined as HZ-associated pain rated as 3 or above on the 'worst pain' ZBPI questionnaire. This Outcome Measure was only assessed participants with confirmed HZ. This analysis involved any subject reporting ZBPI clinically significant pain (i.e. pain with a score of 3 or more on a 0-10 point scale) at any time during the study.|During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.||Days||Standard Deviation|Mean
822774|NCT01165242|Secondary|Number of Subjects With New Onset of Chronic Illness(es) (NOCI)|NOCI included hypersensitivity, insulin resistance, asthma and bronchial hyperreactivity.|From Month 0 through Month 6|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Participants|||Count of Participants
822729|NCT01165177|Secondary|Number of Subjects With a Confirmed HZ Episode Taking Pain Medication Associated With HZ|The analysis focused on subjects taking pain medication due to HZ|During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.||Subjects|||Number
822730|NCT01165177|Secondary|Number of Subjects With a Confirmed HZ Episode Having a Reduction of Duration of Pain Medication Associated With HZ|The analysis focused on patients who experienced a reduction in duration of pain medication administered for HZ in subjects with confirmed HZ.|During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.||Subjects|||Number
822731|NCT01165177|Secondary|Number of Subjects With Confirmed HZ Episode Related Hospitalizations|The analysis focused on confirmed HZ episode related hospitalizations.|During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.||Subjects|||Number
822732|NCT01165177|Secondary|Number of Subjects With HZ Related Complications|The analysis focused on the incidence of HZ complications in subjects with confirmed HZ|During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.||Subjects|||Number
822733|NCT01165177|Secondary|Number of Subjects With Confirmed HZ Episode Related Mortality|The analysis focused on the number of subjects who died due to HZ|During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.||Subjects|||Number
822734|NCT01165177|Secondary|Number of Subjects With a Reduction of Duration of Severe ‘Worst’ HZ-associated Pain|Severe 'worst' pain was defined as HZ-associated pain rated as 3 or above on the 'worst pain' Zoster Brief Pain Inventory (ZBPI) questionnaire. The outcome assessed the duration of severe ‘worst’ HZ-associated pain following the onset of a confirmed HZ rash over the entire pain reporting period as measured by the ZBPI in subjects with confirmed HZ. This analysis involved any subject reporting clinically significant pain (i.e. pain with a score of 3 or more on a 0-10 point scale) at any time during the study.|During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.||Subjects|||Number
822735|NCT01165177|Secondary|Number of Subjects With Any Episodes of Post-Herpetic Neuralgia (PHN)|The incidence of PHN was calculated using the modified total vaccinated chort.|During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.||Subjects|||Number
822736|NCT01165177|Primary|Number of Subjects With Confirmed Herpes Zoster (HZ) Cases|Confirmed HZ cases during the study were assessed in the Modified Total Vaccinated Cohort (mTVc)|During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.||Subjects|||Number
822737|NCT01165203|Secondary|HIV VL|HIV VL was tabulated by HIV status, for subjects with a number of available results greater than or equal to (≥) 40 copies/mL.|At Screening Visit (up to 21 days prior to Month 0), Months 1, 2, 3, 6, 7 and 18|The analysis was performed on the Total Vaccinated cohort, which included only vaccinated subjects with at least one vaccine administration documented, who had available results of ≥ 40 copies/mL.||HIV-RNA copies/mL||Standard Deviation|Mean
822738|NCT01165203|Secondary|CD4 Count|CD4 count was tabulated by HIV status.|At Screening Visit (up to 21 days prior to Month 0), Months 1, 2, 3, 6, 7 and 18|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||CD4 T-cells/million T-cells||Standard Deviation|Mean
822739|NCT01165203|Secondary|Number of Subjects With Any Herpes Zoster (HZ) Cases and Complications||From Month 0 until Month 18|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Participants|||Count of Participants
822740|NCT01165203|Secondary|­Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status|Antibody concentrations were as determined by ELISA and tabulated by HIV status. Anti-VZV and anti-gE antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in mIU/mL.|At Months 0, 1, 2, 3, 6, 7 and 18|The analysis was performed on the ATP cohorts for immunogenicity and for persistence, which included all evaluable subjects for whom data concerning immunogenicity measures were available at the considered time points (up to Month 7 for the ATP cohort for immunogenicity and at Month 18 for the ATP cohort for persistence).||mIU/mL||95% Confidence Interval|Geometric Mean
822741|NCT01165203|Secondary|­Anti-VZV and Anti-gE Antibody Concentrations|Antibody concentrations were as determined by ELISA and tabulated for the main study groups. Anti-VZV and anti-gE antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in mIU/mL.|At Months 0, 1, 2, 3, 6, 7 and 18|The analysis was performed on the ATP cohorts for immunogenicity and for persistence, which included all evaluable subjects for whom data concerning immunogenicity measures were available at the considered time points (up to Month 7 for the ATP cohort for immunogenicity and at Month 18 for the ATP cohort for persistence).||mIU/mL||95% Confidence Interval|Geometric Mean
822742|NCT01165203|Secondary|­Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status|The analysis focused on CD4 T-cells expressing at least 2 cytokines (among IFN-g, IL-2, TNF-a and/or CD40L as determined by ICS at Months 0, 1, 2, 3, 6, 7 and 18 and tabulated by HIV status.|At Months 0, 1, 2, 3, 6, 7 and 18|The analysis was performed on the ATP cohorts for immunogenicity and for persistence, which included all evaluable subjects for whom data concerning immunogenicity measures were available at the considered time points (up to Month 7 for the ATP cohort for immunogenicity and at Month 18 for the ATP cohort for persistence).||CD4 T-cells/million T-cells||Standard Deviation|Mean
822743|NCT01165203|Secondary|­Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells|The analysis focused on CD4 T cells expressing at least 2 cytokines (among IFN-g, IL-2, TNF-a and/or CD40L as determined by ICS at Months 0, 1, 2, 3, 6, 7 and 18 and tabulated for the main study groups.|At Month 0, 1, 2, 3, 6, 7 and 18|The analysis was performed on the ATP cohorts for immunogenicity and for persistence, which included all evaluable subjects for whom data concerning immunogenicity measures were available at the considered time points (up to Month 7 for the ATP cohort for immunogenicity and at Month 18 for the ATP cohort for persistence).||CD4 T-cells/million T-cells||Standard Deviation|Mean
822744|NCT01165203|Primary|­Anti-gE Antibody (Ab) Concentrations|­Anti-gE antibody (Ab) concentrations were determined by Enzyme-Linked Immunosorbent Assay (ELISA) at Month 7 in ART and non-ART cohorts presenting high CD4 counts at enrolment. Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL).|At Month 7|||mIU/mL||95% Confidence Interval|Geometric Mean
822745|NCT01165203|Primary|Frequency of gE-specific CD4 T-cells|The analysis focused on CD4 T-cells expressing at least 2 cytokines (among interferon-gamma (IFN-g) , interleukin-2 (IL-2), tumour necrosis factor-alpha (TNF-a) and/or CD40 ligand (CD40L)) as determined by in vitro intracellular cytokine staining (ICS) at Month 7 in ART and non-ART cohorts presenting high CD4 counts at enrollment.|At Month 7|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available at Month 7.||CD4 T-cells/million T-cells||Standard Deviation|Mean
822746|NCT01165203|Primary|Number of Subjects With Any Pre-defined Changes in HIV Viral Load (VL) and CD4 T-cell Count, by HIV Status|In this analysis, results were tabulated by HIV status.|From Month 1 to Month 7|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Participants|||Count of Participants
822747|NCT01165203|Primary|Number of Subjects With Any AIDS-defining Condition, by HIV Status|In this analysis, results were tabulated by HIV status|From Month 0 to Month 18|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Participants|||Count of Participants
822748|NCT01165203|Primary|Number of Subjects With Any Significant Change in Antiretroviral Therapy (ART), Including Initiation of ART in ART-naïve Subjects, by HIV Status|In this analysis, results were tabulated by HIV status|From Month 0 to Month 18|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Participants|||Count of Participants
822749|NCT01165203|Primary|Number of Subjects With Any Pre-defined Changes in HIV Viral Load (VL) and CD4 T-cell Count|In this analysis, results were tabulated for the main study groups.|From Month 1 to Month 7|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Participants|||Count of Participants
822750|NCT01165203|Primary|Number of Subjects With Any AIDS-defining Condition|In this analysis, results were tabulated for the main study groups.|From Month 0 until Month 18|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Participants|||Count of Participants
822751|NCT01165203|Primary|Number of Subjects With Any Significant Change in Antiretroviral Therapy (ART), Including Initiation of ART in ART-naïve Subjects|In this analysis, results were tabulated for the main study groups. Significant changes to ART appeared due to failure to control HIV viral load and due to failure to maintain high CD4 cells count.|From Month 0 until Month 18|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Participants|||Count of Participants
822752|NCT01165203|Primary|Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges|The assessed parameters were Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Basophils, Bilirubin Total, Bilirubin Conjugated / Direct, Creatinine, Eosinophils, Glucose, Bicarbonate, Haemoglobin, Potassium, Lymphocytes, Monocytes, Sodium, Neutrophils, Platelets and White Blood Cells. Tabulation was made by relation to the normal laboratory ranges: below, within or above, and also staus unknown.|At Month 7|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Participants|||Count of Participants
822753|NCT01165203|Primary|Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges|The assessed parameters were Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Basophils, Bilirubin Total, Bilirubin Conjugated / Direct, Creatinine, Eosinophils, Glucose, Bicarbonate, Haemoglobin, Potassium, Lymphocytes, Monocytes, Sodium, Neutrophils, Platelets and White Blood Cells. Tabulation was made by relation to the normal laboratory ranges: below, within or above, and also status unknown.|At Month 6|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Participants|||Count of Participants
822754|NCT01165203|Primary|Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges|The assessed parameters were Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Basophils, Bilirubin Total, Bilirubin Conjugated / Direct, Creatinine, Eosinophils, Glucose, Bicarbonate, Haemoglobin, Potassium, Lymphocytes, Monocytes, Sodium, Neutrophils, Platelets and White Blood Cells. Tabulation was made by relation to the normal laboratory ranges: below, within or above, and also staus unknown.|At Month 3|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Participants|||Count of Participants
822755|NCT01165203|Primary|Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges|The assessed parameters were Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Basophils, Bilirubin Total, Bilirubin Conjugated / Direct, Creatinine, Eosinophils, Glucose, Bicarbonate, Haemoglobin, Potassium, Lymphocytes, Monocytes, Sodium, Neutrophils, Platelets and White Blood Cells. Tabulation was made by relation to the normal laboratory ranges: below, within or above, and also status unknown.|At Month 2|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Participants|||Count of Participants
822756|NCT01165203|Primary|Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges|The assessed parameters were Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Basophils, Bilirubin Total, Bilirubin Conjugated / Direct, Creatinine, Eosinophils, Glucose, Bicarbonate, Haemoglobin, Potassium, Lymphocytes, Monocytes, Sodium, Neutrophils, Platelets and White Blood Cells. Tabulation was made by relation to the normal laboratory ranges: below, within or above, and also status unknown.|At Month 1|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Participants|||Count of Participants
822757|NCT01165203|Primary|Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges|The assessed parameters were Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Basophils, Bilirubin Total, Bilirubin Conjugated / Direct, Creatinine, Eosinophils, Glucose, Bicarbonate, Haemoglobin, Potassium, Lymphocytes, Monocytes, Sodium, Neutrophils, Platelets and White Blood Cells. Tabulation was made by relation to the normal laboratory ranges: below, within or above, and also status unknown.|At Screening Visit (up to 21 days prior to Month 0)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Participants|||Count of Participants
822758|NCT01165203|Primary|Number of Subjects With Unsolicited AEs|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|Within 30 days (Days 0-29) after each vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Participants|||Count of Participants
822759|NCT01165203|Primary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal (symptoms included nausea, vomiting, diarrhoea and/or abdominal pain), headache, myalgia, shivering and temperature [defined as oral/axillary temperature above (>) 37.5 degrees Celsius (°C)]. Any = incidence of a particular symptom regardless of their intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Participants|||Count of Participants
822760|NCT01165203|Primary|Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = incidence of a particular symptom regardless of their intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented, who had their symptom sheets filled in.||Participants|||Count of Participants
822761|NCT01165203|Primary|Number of Subjects With Any Adverse Events (AEs) of Specific Interest|AEs of specific interest include new onset of autoimmune diseases (NOADs) and other immune mediated inflammatory disorders from administration of the first dose of vaccine/placebo.|From Month 0 until Month 18|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Participants|||Count of Participants
822762|NCT01165203|Primary|Number of Subjects With Any Fatal SAEs|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From screening (up to 21 days prior to Month 0) until Month 18|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Participants|||Count of Participants
822763|NCT01165203|Primary|Number of Subjects With SAEs Related to Study Participation or to a Concurrent GSK Medication/Vaccine|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From screening (up to 21 days prior to Month 0) until Month 18|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Participants|||Count of Participants
822764|NCT01165203|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Month 0 to Month 18|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Participants|||Count of Participants
822810|NCT01165450|Secondary|Time to Complete Re-epithelialization of the Study Eye|Resolution of epithelial defect is defined as the largest diameter of the epithelial defect being less than 0.5 mm, as it is difficult to distinguish a smaller defect from the small amount of fluorescing staining seen in a healed defect. Time of complete re-epithelialization will be defined as the midpoint between the last observed date with an epithelial defect and the date of the first visit with no epithelial defect, up to Day 28 ± 2.|28 ± 2 days|The study was terminated prematurely, data were never analyzed; PI has left the institution and data are no longer available.|||||
822765|NCT01165216|Secondary|Serum Half-life (T-HALF) of Ipilimumab|T-HALF was calculated as the ratio of ln(2) to elimination rate constant (K), where K was estimated as negative slope obtained by regression of the terminal log-linear portion of the serum concentration vs time profile following the ipilimumab dose on Day 1 of Cycle 3. Individual patient pharmacokinetic (PK) parameter values were derived by noncompartmental methods, using a validated PK analysis program. Actual times were used for the analyses. T-HALF measurements were performed during the 3rd cycle; at predose and at 1.5, 4 , 24 (Day 2), 48 (Day 3), 168 hrs (Day 8),and 336 (Day 15) hours postdose; during the 4th and subsequent cycle, predose ipilimumab; and off-treatment until progression of disease, toxicities requiring discontinuation, withdrawal of consent, or study closure.|During Cycle 3: predose and 1.5, 4, 24, 48, 168, and 336 hours postdose ipilimumab|Participants who received at least 1 dose of ipilimumab||Days||Standard Deviation|Mean
822766|NCT01165216|Secondary|Time of Maximum Observed Serum Concentration (Tmax)|Tmax was recorded directly from experimental observations. Actual times were used for the analyses. Tmax measurements were performed during the 3rd cycle; at predose and at 1.5, 4 , 24 (Day 2), 48 (Day 3), 168 hrs (Day 8),and 336 (Day 15) hours postdose; during the 4th and subsequent cycle, predose ipilimumab; and off-treatment until progression of disease, toxicities requiring discontinuation, withdrawal of consent, or study closure.|During Cycle 3: predose and 1.5, 4, 24, 48, 168, and 336 hours postdose ipilimumab|Participants who received at least 1 dose of ipilimumab||Hours||Full Range|Median
822767|NCT01165216|Secondary|Area Under the Concentration Curve From Time 0 to Day 21 (in 1 Interval Dosing) (AUC[0-21d]) for Ipilimumab|The AUC(0-21d) was calculated using a mixture of log- and linear-trapezoidal summations. Using no weighting factor, the terminal log-liner phase of the concentration-time curve was determined by least-square linear regression of at least 3 data points. Individual patient pharmacokinetic (PK) parameter values were derived by noncompartmental methods using a validated PK analysis program. Actual times were used for the analyses. AUC(0-21d) measurements were performed during the 3rd cycle, at predose and at 1.5, 4 , 24 (Day 2), 48 (Day 3), 168 hrs (Day 8),and 336 (Day 15) hours postdose; during the 4th and subsequent cycle, predose ipilimumab; and off-treatment until progression of disease, toxicities requiring discontinuation, withdrawal of consent; or study closure.|During Cycle 3: predose and 1.5, 4, 24, 48, 168, and 336 hours postdose ipilimumab|Participants who received at least 1 dose of ipilimumab||ug*h/mL||Geometric Coefficient of Variation|Geometric Mean
822768|NCT01165216|Secondary|Trough Observed Serum Concentration (Cmin) of Ipilimumab|Cmin was recorded directly from experimental observations. Actual times were used for the analyses. Cmin measurements were performed during the 3rd cycle, at predose and at 1.5, 4 , 24 (Day 2), 48 (Day 3), 168 (Day 8), and 336 (Day 15) hours postdose; during the 4th and subsequent cycle, predose ipilimumab; and off-treatment until progression of disease, toxicities requiring discontinuation, withdrawal of consent; or study closure.|During Cycle 3: predose and 1.5, 4, 24, 48, 168, and 336 hours postdose ipilimumab|Participants who received at least 1 dose of ipilimumab||ug/mL||Standard Deviation|Mean
822769|NCT01165216|Secondary|Maximum Serum Concentration (Cmax) of Ipilimumab|Cmax was recorded directly from experimental observations. Actual times were used for the analyses. Cmax measurements were performed during the 3rd cycle; at predose and at 1.5, 4 , 24 (Day 2), 48 (Day 3), 168 hrs (Day 8),and 336 (Day 15) hours postdose; during the 4th and subsequent cycle, predose ipilimumab; and off-treatment until progression of disease, toxicities requiring discontinuation, withdrawal of consent, or study closure.|During Cycle 3: predose and 1.5, 4, 24, 48, 168, and 336 hours postdose ipilimumab|Participants who received at least 1 dose of ipilimumab||ug/mL||Geometric Coefficient of Variation|Geometric Mean
822770|NCT01165216|Secondary|Number of Participants With Best Overall Response (BOR) of Partial Response (PR) or Stable Disease|Tumor response was determined for all participants with measurable lesions by radiologic responses as defined by Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. The BOR was the best response recorded from start of treatment until disease progression/recurrence. RECIST for target lesions: PR=at least a 30% decrease in the sum of the longest dimension (LD) of target lesions, taking as reference the baseline sum LD; stable disease=neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD since the treatment started. At minimum, tumor measurements were to be obtained at screening, every 6 weeks (±1 week) during the induction phase and every 12 weeks (±1 week) during the maintenance phase.|Day 1 of Cycle 3, Day 1 of Cycle 5, and Day 22 of Cycle 6|Participants who received at least 1 dose of study drug||Participants|||Number
822771|NCT01165216|Secondary|Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Drug-related Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs Leading to Discontinuation|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or unknown relationship to study drug. AE incidence was assessed from Day 1 until Week 24 and every 12 weeks thereafter during the maintenance period, until discontinuation of study drug, due to progression of disease, toxicities requiring discontinuation, withdrawal of consent, or study closure, and at least every 4 weeks(±1 week) until all study drug-related toxicities had recovered to resolved, stabilized or returned to baseline or were deemed irreversible during the follow-up period).|Continuously from Day 1 to Week 24 and every12 weeks thereafter during maintenance until discontinuation of drug|Participants who received at least 1 dose of any study drug||Participants|||Number
822772|NCT01165216|Primary|Number of Participants Experiencing a Dose-limiting Toxicity (DLT)|A DLT was defined as study drug-related adverse event occurring during the first 2 cycles after ipilimumab administration in the induction phase and was any of the following: Grade 4 absolute neutrophil count (ANC) decreased (<500 cells/ mm^3) for 7 or more consecutive days; febrile Neutropenia (body temperature ≥38.5° C with ANC <1000 /mm^3) lasting >3 days; Grade 4 platelet count decreased (<25,000 cells/mm^3) or Grade 3 platelet count decreased requiring a platelet transfusion; Grade 3 or greater nausea, vomiting, diarrhea, despite the use of adequate/maximal medical intervention; Grade 3 or greater aspartate transaminase/alanine transaminase level and rash that has not resolved to Grade 2 or lower within 2 weeks after onset; or any Grade 3 or greater nonhematologic toxicity (except Grade 3 fatigue, Grade 3 asthenia, Grade 3 transient arthralgia/myalgia, or Grade 3 transient abnormal electrolyte levels).|Day 1 of Cycles 1 and 2 From Day 1 of Cycle 3 to Day 21 of Cycle 4|Participants who received at least 1 dose of ipilimumab||Participants|||Number
822775|NCT01165242|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within 31 days (Day 0-30) post-vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Participants|||Count of Participants
822776|NCT01165242|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal, headache and temperature [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, who had their symptom sheets filled in.||Participants|||Count of Participants
822777|NCT01165242|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, who had their symptom sheets filled in.||Participants|||Count of Participants
822778|NCT01165242|Secondary|Number of Subjects With Vaccine Response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies|Vaccine response was defined as: -for initially seronegative subjects [with hSBA titer below (<) 1:4]: post-vaccination antibody titer greater than or equal to (≥) 1:8 one month after vaccination; -for initially seropositive subjects (with hSBA titer ≥ 1:4): post-vaccination antibody titer ≥ 4-fold the pre-vaccination antibody titer one month after vaccination.|One month after vaccinattion (Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the study vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.||Participants|||Count of Participants
822779|NCT01165242|Secondary|hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers|Antibody titers are presented as geometric mean titers (GMTs).|Prior to (PRE) and one month after vaccination (Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the study vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component.||Titers||95% Confidence Interval|Geometric Mean
822780|NCT01165242|Secondary|Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value|The cut-off value for the hSBA-Men titers was greater than or equal to (≥) 1:8.|Prior to (PRE) and one month after vaccination (Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the study vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component.||Participants|||Count of Participants
822781|NCT01165242|Secondary|Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value|The cut-off value for the hSBA-Men titers was greater than or equal to (≥) 1:4.|Prior to (PRE) and one month after vaccination (Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the study vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component.||Participants|||Count of Participants
822782|NCT01165242|Primary|Number of Subjects With Vaccine Response to Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibodies|"Vaccine response was defined as:
for initially seronegative subjects [with hSBA titer below (<) 1:4]: post-vaccination antibody titer greater than or equal to (≥) 1:8 one month after vaccination;
for initially seropositive subjects (with hSBA titer ≥ 1:4): post-vaccination antibody titer ≥ 4-fold the pre-vaccination antibody titer one month after vaccination."|One month after vaccination (Month 1)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received the study vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.||Participants|||Count of Participants
822783|NCT01165281|Secondary|Number of Patients Who Discontinued Due to Lack of Efficacy|The duration from the date of first study drug intake to treatment discontinuation due to lack of efficacy.|4 weeks|Time to discontinuation due to lack of efficacy was not analyzed since there was only 1 patient in the per-protocol set (in the tapentadol group) who discontinued treatment due to lack of efficacy.||Number of participants|||Number
822784|NCT01165281|Secondary|Proportion of Patients Entering the Maintenance Period|Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period.|4 weeks|Per-protocol population included all patients who were randomized, received at least 1 dose of study drug, had post-baseline efficacy data and didn’t have major protocol deviations (including use of prohibited concomitant medications, non-compliance, failure to meet selection criteria, violation of regulatory requirements, or treatment deviation).||Percentage of Participants|||Number
822785|NCT01165281|Secondary|Proportion of Patients With Various Levels of Pain Improvement (Responders)|The proportion of patients with at least a 30 percentage improvement based on the percent change from baseline in Numerical Rating Scale score during the last 3 days of the double-blind treatment period.|Baseline, Last 3 Days of Study Drug Administration (4 weeks)|Per-protocol population included all patients who were randomized, received at least 1 dose of study drug, had post-baseline efficacy data and didn’t have major protocol deviations (including use of prohibited concomitant medications, non-compliance, failure to meet selection criteria, violation of regulatory requirements, or treatment deviation).||Percentage of Participants|||Number
822786|NCT01165281|Secondary|Total Daily Dose of Rescue Medication Use for the Double-blind Treatment Period|During the study, if a patient experienced breakthrough pain (pain that occurs for short periods of time between doses of study drug), treatment with rescue medication (morphine immediate release [IR] 5 mg) was to be given. The average total daily dose of Morphine IR taken (mg) was assessed.|4 weeks|This is a subset of the per-protocol population that included patients who received at least 1 dose of rescue medication. The per-protocol population included all patients who were randomized, received at least 1 dose of study drug, had post-baseline efficacy data and didn’t have major protocol deviations.||Milligrams||Standard Deviation|Mean
822787|NCT01165281|Secondary|Frequency of Rescue Medication Use for the Double-blind Treatment Period|During the study, if a patient experienced breakthrough pain (pain that occurs for short periods of time between doses of study drug), treatment with rescue medication (morphine immediate release [IR] 5 mg) was to be given. The average number of doses of Morphine IR taken per day was assessed.|4 weeks|This is a subset of the per-protocol population that included patients who received at least 1 dose of rescue medication. The per-protocol population included all patients who were randomized, received at least 1 dose of study drug, had post-baseline efficacy data and didn’t have major protocol deviations.||Number of doses per day||Standard Deviation|Mean
822788|NCT01165281|Secondary|Percentage of Patients in Patient Global Impression of Change (PGIC) Score Categories|The PGIC was rated by the patient and was based on the single question “Since the start of this treatment, my cancer-related pain overall is,” where 1=very much improved, 2=much improved, 3=minimally improved, 4=not changed, 5=minimally worse, 6=much worse, 7=very much worse.|Baseline, Endpoint of the 4-week Treatment Period|Per-protocol population included all patients who were randomized, received at least 1 dose of study drug, had post-baseline efficacy data and didn’t have major protocol deviations (including use of prohibited concomitant medications, non-compliance, failure to meet selection criteria, violation of regulatory requirements, or treatment deviation).||Percentage of Participants|||Number
822789|NCT01165281|Primary|Change From Baseline to the Last 3 Days of Study Drug Administration (Last Observation Carried Forward) in the Score for Average Pain Intensity on an 11-point Numerical Rating Scale|The patients recorded their average pain intensity over the past 24 hours once daily in the evening and at the same time as much as possible (eg, 10:00 PM) throughout the study in response to the following question: “What has your average pain level been for the past 24 hours, where 0=no pain and 10=pain as bad as you can imagine.” The score at 3 days before the completion of study drug administration was defined as the average pain intensity score averaged over the last 3 days before completion of study drug administration.|Baseline, Last 3 Days of Study Drug Administration (4 weeks)|Per-protocol population included all patients who were randomized, received at least 1 dose of study drug, had post-baseline efficacy data and didn’t have major protocol deviations (including use of prohibited concomitant medications, non-compliance, failure to meet selection criteria, violation of regulatory requirements, or treatment deviation).||Scores on scale||Standard Deviation|Mean
822790|NCT01165307|Secondary|Subject Satisfaction at 12 Months|Subject satisfaction was ascertained by asking study participants to choose from one of four categories relating to their general satisfaction with treatment: totally satisfied, generally satisfied, acceptable improvement in symptoms, or unacceptable treatment.|Measured at 12 months following initial treatment|Only subjects who completed the 12 month visit were included in the analysis.||participants|||Number
822791|NCT01165307|Secondary|Pain at 12 Months as Measured by the Pain Visual Analog Scale (VAS)|The pain VAS is a continuous scale comprised of a horizontal (HVAS) line, 100 mm in length. Possible scores range from 0 (no pain) to 100 (worst possible pain). The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks.|Measured at 12 months following initial treatment|Only subjects who completed the 12 month visit were included in the analysis.||mm||Inter-Quartile Range|Median
822792|NCT01165307|Secondary|Bleeding Pattern at 12 Months|"The menstruation pattern of the subjects was evaluated. A bleeding episode was defined as any set of one or more bleeding days bounded at each end by two or more bleeding-free days. The bleeding pattern was analyzed using a 90 day reference period and divided into groups, (based on World Health Organization (WHO) classification of clinically important bleeding patterns). The groups are Amenorrhea (no bleeding during the reference period); Infrequent bleeding (fewer than 3 bleeding episodes); Irregular bleeding (between 3 and 5 episodes with less than 3 bleeding-free intervals of length 14 days or more); Prolonged bleeding (1 or more bleeding episodes lasting 14 days or more); Eumenorrhea normal pattern (none of the above patterns)."|Measured at 12 months following initial treatment|Only subjects who completed the 12 month visit were included in the analysis.||participants|||Number
822793|NCT01165307|Secondary|Indirect Medical Costs|Indirect cost A refers to cost of sanitary products and lack of activity, indirect cost B refers to cost of sanitary products and reduced work days, and indirect cost C refers to cost of sanitary products, lack of activity, and reduced work days.|Measured at 12 months following initial treatment|Only subjects who completed the 12 month visit were included in the analysis.||dollars||Standard Deviation|Mean
822794|NCT01165307|Secondary|Direct Medical Costs|Direct Medical Costs consisted of two categories: primarily hospital billed services, and primarily physician billed services. Primary hospital billed services were as defined by Medicare billing practice.|Measured at 12 months following initial treatment|Only subjects who completed the 12 month visit were included in the analysis.||dollars||Standard Deviation|Mean
822795|NCT01165307|Secondary|Change in Ferritin From Baseline||Measured at 12 months following initial treatment|Only subjects who completed the 12 month visit were included in the analysis.||ug/L||Inter-Quartile Range|Median
822796|NCT01165307|Secondary|Ferritin at 12 Months||Measured at 12 months following initial treatment|Only subjects who completed the 12 month visit were included in the analysis.||ug/L||Inter-Quartile Range|Median
822797|NCT01165307|Secondary|Change in Hemoglobin||baseline, 12 months|Only subjects who completed the 12 month visit were included in the analysis.||g/dL||Inter-Quartile Range|Median
822798|NCT01165307|Secondary|Hemoglobin at 12 Months||Measured at 12 months following initial treatment|Only subjects who completed the 12 month visit were included in the analysis.||g/dL||Inter-Quartile Range|Median
824920|NCT01178671|Secondary|Response Status|Responders defined by Clinician Administered Posttraumatic Stress Disorder Scale total score decreased by at least 30% compared with baseline and Clinical Global Impression improvement score of =1 or 2 at endpoint|up to 24 weeks|intent to treat||percentage of subjects|||Number
822799|NCT01165307|Secondary|Quality of Life as Measured by the Menorrhagia Multi-Attribute Scale (MMAS )|The MMAS questionnaire captures the subjective consequences of menorrhagia on six domains: practical difficulties; social life; psychological wellbeing; physical health; work routine; and family life. Each of the six domains has four statements that represent four levels of response. Respondents indicate the statement that best matches their feelings for each domain. The statement scores derive from a weighting of the domains and a weighting of the statements in level of severity by women in the original study. Scores range from 0 (worst possible state in all domains) to 100 (best possible state in all domains).|Measured at 12 months following initial treatment|Only subjects who completed the 12 month visit were included in the analysis.||units on a scale||Inter-Quartile Range|Median
822800|NCT01165307|Secondary|Quality of Life Score Using the Short Form-12 (SF-12) Health Survey|Quality of life (QoL) was measured by the SF-12 questionnaire. The SF-12 is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey. Physical and Mental Health Composite Scores are computed (combined, scored, and weighted) using the scores of the 12 questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. Improvement was defined as a change of ≥ 6 points.|Measured at 12 months following initial treatment|Only subjects who completed the 12 month visit were included in the analysis.||units on a scale||Standard Deviation|Mean
822801|NCT01165307|Primary|Menstrual Blood Loss (MBL) as Measured by Pictorial Blood Loss Assessment Chart (PBLAC).|The PBLAC is a simple, pictorial tool used in women with menorrhagia to assess menstrual blood loss. The total score is calculated by adding up the sum of all scores for the tampons or sanitary napkin used in the menstrual cycle. For tampons: 1 for lightly stained, 5 for moderately soiled and 10 for completely saturated tampons. For sanitary napkins: 1 for lightly stained, 5 for moderately soiled, and 20 for completely saturated pads. Clots were given a score of 1 for small and 5 for large clots. Abnormal PBLAC bleeding score greater than or equal to 100, which correlates with menorrhagia, defined as greater than 80 mL of menstrual blood loss. Normal bleeding is defined as a score of 75 or less. A score of 0 indicates amenorrhea, or absence of menstruation.|Measured at 12 months following initial treatment|Only subjects who completed the 12 month visit were included in the analysis.||units on a scale||Inter-Quartile Range|Median
822802|NCT01165320|Primary|Percentage of Participants With One or More Drug-Related Adverse Experiences|An adverse experience (AE) is defined as any unfavorable or unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an AE. A drug-related AE is one judged to be definitely, probably, or possibly related to the study drug.|Invasive candidiasis: up to 70 days; aspergillosis: up to 98 days|The full analysis set included all enrolled participants who received >=1 dose of study drug. No participants with esophageal candidiasis were identified for inclusion in the study and assessment for safety outcomes.||Percentage of Participants|||Number
822803|NCT01165320|Primary|Percentage of Participants With an Overall Favorable Response to Therapy|Invasive candidiasis: favorable overall response required resolved clinical findings and negative culture test for Candida species on follow-up. If Candida species were not observed in the baseline blood culture, favorable overall response required resolved clinical findings and resolved or improved radiographic findings. Aspergillosis: favorable overall response required resolved, improved, or unchanged clinical findings and resolved or improved radiographic findings, or resolved or improved clinical findings and resolved, improved, or stable radiographic findings.|Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days|"The full analysis set included all enrolled participants who received >=1 dose of study drug. No participants with esophageal candidiasis were identified for inclusion in the study and assessment for response to therapy. Participants whose overall response assessment was unable to judge were counted as having an unfavorable response."||Percentage of Participants|||Number
822804|NCT01165424|Secondary|Change From Baseline in the Total Nasal Symptom Score|Total nasal symptom score was a composite of 4 symptoms (sneezing, rhinorrhea, nasal congestion, and nasal itching). Each symptom was scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe for a total score ranging from 0 to 12. A higher score indicates more severe symptoms.|Baseline and Weeks 2, 4, 8, 12, and 24 (or discontinuation)|All treated participants||units on a scale||Standard Error|Mean
822805|NCT01165424|Primary|Number of Participants With Adverse Events and Adverse Drug Reactions||Baseline to Week 24|All treated participants||participants|||Number
822806|NCT01165450|Secondary|Percent Reduction of Corneal Epithelial Defect at Day 28 ± 2 in the Study Eye|To compare, in each of the two patient populations, the percent reduction in epithelial defect size at Day 28 ± 2 compared to baseline, as measured by slit lamp examination with fluorescein staining. Epithelial defect size determined by pseudo-area, defined by the longest diameter of the lesion multiplied by the longest perpendicular to this longest diameter.|28 ± 2 days|The study was terminated prematurely, data were never analyzed; PI has left the institution and data are no longer available.|||||
822807|NCT01165450|Secondary|Persistence of Complete Corneal Re-epithelialization in the Study Eye|To determine whether or not complete corneal re-epithelialization was persistent, as determined by whether the healed epithelium remains intact after complete re-epithelialization is confirmed in the study eye. The measurement will be made at Day 28 ± 2.|28 ± 2 days|The study was terminated prematurely, data were never analyzed; PI has left the institution and data are no longer available.|||||
822808|NCT01165450|Secondary|Change in the Rate of Re-epithelialization of the Study Eye|"To determine the change in the rate of re-epithelialization of the study eye from the screening run-in period to the treatment period, if applicable.
Time Frame: Screening period is defined as Day -7 to Day 0 ± 1. Treatment period is defined as Day 0 ± 1 through time of complete re-epithelialization. Time of complete re-epithelialization is defined as the midpoint between the last observed date with an epithelial defect and the date of the first visit with no epithelial defect, up to Day 28 ± 2."|35 ± 2 days|The study was terminated prematurely, data were never analyzed; PI has left the institution and data are no longer available.|||||
822809|NCT01165450|Secondary|Complete Healing of the Corneal Epithelial Defect at Day 14 ± 1 in the Study Eye|To determine binary indicator of whether or not healing has occurred at 14 ± 1 days, defined as the largest diameter of the epithelial defect being smaller than 0.5 mm as determined by slit lamp examination with fluorescein staining.|14 ± 1 days|The study was terminated prematurely, data were never analyzed; PI has left the institution and data are no longer available.|||||
822811|NCT01165450|Primary|Incidence of Adverse Events Following Application of the Investigational Product in All Subjects|Primary safety measure: To determine incidence of adverse events by recording their occurrence at each study visit through Day 28 ± 2. Analysis of safety data will be performed prior to each dose-escalation. If greater than 2 serious adverse events are found that are causally related to the investigational product, the study will be halted.|28 ± 2 days|The study was terminated prematurely, data were never analyzed; PI has left the institution and data are no longer available.|||||
822812|NCT01165450|Primary|Percent Healing of the Corneal Epithelial Defect at Day 14 ± 1 in the Study Eye|Primary efficacy measure: To determine whether topical treatment of persistent epithelial defects with Nexagon preparations yields greater healing at Day 14 ± 1, compared to vehicle alone, in individuals having had diabetic vitrectomy. Healing will be determined by comparing pseudo-area (as measured by Investigator, or designated ophthalmologist) at baseline (taken just prior to the first treatment) and Day 14 ± 1. Pseudo-area is defined by the longest diameter of the lesion multiplied by the longest perpendicular to this longest diameter.|14 ± 1 days|The study was terminated prematurely, data were never analyzed; PI has left the institution and data are no longer available.|||||
822813|NCT01165541|Primary|Number of Very Heavy Drinking Days Per Week|The number of “very heavy” drinking days (8 or more drinks per drinking day for men or 6 or more drinks per drinking day for women) per week|14 Weeks|The Analysis Population only consists of participants that completed both phases of the study.||days||Standard Deviation|Mean
822814|NCT01165554|Secondary|Blinded Visual Interpretation of Each Subject’s Flutemetamol F 18 Injection Brain PET Images as Normal, With Anatomic CT Brain Images for Reference.|Blinded visual interpretation of each subject’s Flutemetamol F 18 Injection brain PET images as normal, with anatomic CT brain images for reference.|Post flutemetamol administration.|||Percent of Specificity-Normal Reads||95% Confidence Interval|Number
822815|NCT01165554|Secondary|Blinded Visual Interpretation of Each Subject’s Flutemetamol F 18 Injection Brain PET Images as Abnormal, With Anatomic CT Brain Images for Reference.|Blinded visual interpretation of each subject’s Flutemetamol F 18 Injection brain PET images as abnormal, with anatomic CT brain images for reference.|Post flutemetamol administration.|||Percent of Sensitivity-Abnormal Reads||95% Confidence Interval|Number
822816|NCT01165554|Secondary|Blinded Visual Interpretation of Each Subject’s Flutemetamol F 18 Injection Brain PET Images as Normal, Without Anatomic Brain Images.|"A calculation used to assess Specificity was (Number of Blinded Reads determined normal by Reader N) divided by the (Total number of normal participants).
Blinded visual interpretation of each subject’s Flutemetamol F 18 Injection brain PET images as normal, without anatomic brain images."|Post Flutemetamol administrations|The assessment was done post-mortum based on the estimates of the presence of amyloid plaque in the brain.||Percentage of Specificity by Reader|||Number
822817|NCT01165554|Primary|The Sensitivity of Blinded Visual Interpretations of [18F]Flutemetamol Positron Emission Tomography (PET) Images Without Anatomic Brain Images for Detecting Brain Fibrillar Amyloid β.|"A calculation used to assess Sensitivity was (Number of Blinded Reads determined abnormal by Reader N) divided by the (Total number of abnormal participants).
Blinded visual interpretations of [18F]flutemetamol Positron Emission Tomography (PET) images without anatomic brain images for detecting brain fibrillar amyloid β."|Post flutemetamol administration.|The assessments were post-mortum based on the estimates of the presence of amyloid plaque in the brain.||Percentage of Sensitivity by Reader|||Number
822818|NCT01165684|Secondary|Hypoglycaemic Episodes (Rate of All Treatment Emergent Hypoglycaemia Episodes)|A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and no later than 1 day after the last day of randomised treatment.|Week 0 to Week 32|Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator. 397 subjects contributed with data.||Episodes /year of patient exposure|||Number
822819|NCT01165684|Secondary|Body Mass Index (BMI) at Week 32|Estimated mean BMI after 32 Weeks of treatment|Week 32|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 378 subjects contributed to the statistical analysis at Week 32.||kg/m^2||Standard Error|Mean
822820|NCT01165684|Secondary|Body Weight at Week 32|Estimated mean body weight after 32 Weeks of treatment|Week 32|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 378 subjects contributed to the statistical analysis at Week 32.||kg||Standard Error|Mean
822821|NCT01165684|Secondary|Mean Plasma Glucose Increment Over 3 Meals (Breakfast, Lunch and Dinner) at Week 32|Estimated mean plasma glucose increment over 3 meals (breakfast, lunch and dinner) at Week 32|Week 32|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 352 subjects contributed to the statistical analysis at Week 32.||mmol/L||Standard Deviation|Mean
822822|NCT01165684|Secondary|Mean Plasma Glucose Increment Over 3 Meals (Breakfast, Lunch and Dinner) at Week 21|Mean plasma glucose increment over 3 meals (breakfast, lunch and dinner) at Week 21|Week 21|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 343 subjects contributed to the data at Week 21.||mmol/L||Standard Deviation|Mean
822823|NCT01165684|Secondary|Mean Plasma Glucose Increment Over 3 Meals (Breakfast, Lunch and Dinner) at Week 10|Mean plasma glucose increment over 3 meals (breakfast, lunch and dinner) at Week 10|Week 10|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 326 subjects contributed to the data at Week 10.||mmol/L||Standard Deviation|Mean
822824|NCT01165684|Secondary|Fasting Plasma Glucose (FPG) at Week 32|Estimated Mean FPG at Week 32|Week 32|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 383 subjects contributed to the statistical analysis at Week 32.||mmol/L||Standard Error|Mean
822825|NCT01165684|Secondary|Fasting Plasma Glucose (FPG) at Week 21|Mean FPG at Week 21|Week 21|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 383 subjects contributed to the data at Week 21.||mmol/L||Standard Deviation|Mean
822826|NCT01165684|Secondary|Fasting Plasma Glucose (FPG) at Week 10|Mean FPG at Week 10|Week 10|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 368 subjects contributed to data at Week 10.||mmol/L||Standard Deviation|Mean
822829|NCT01165684|Secondary|Proportion of Subjects Reaching Glycosylated Haemoglobin (HbA1c) Below 7.0% at Week 10|Proportion of subjects reaching HbA1c below 7.0% at Week 10|Week 10|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 376 subjects contributed to the statistical analysis at Week 10.||percentage (%) of subjects|||Number
822830|NCT01165684|Secondary|Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 21|Estimated mean change from baseline in HbA1c after 21 Weeks of treatment|Week 0, Week 21|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 383 subjects contributed to the statistical analysis at Week 21.||percentage of glycosylated haemoglobin||Standard Error|Mean
822831|NCT01165684|Secondary|Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 10|Estimated mean change from baseline in HbA1c after 10 Weeks of treatment|Week 0, Week 10|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 376 subjects contributed to the statistical analysis at Week 10.||percentage of glycosylated haemoglobin||Standard Error|Mean
822832|NCT01165684|Primary|Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 32|Estimated mean change from baseline in HbA1c after 32 Weeks of treatment|Week 0, Week 32|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 383 subjects contributed to the statistical analysis at Week 32.||percentage of glycosylated haemoglobin||Standard Error|Mean
822833|NCT01158534|Secondary|Number of Patients With Statistically Significant Change in Cellular Immune Parameters From Baseline to 2 Months|To evaluate the effect of celecoxib and interferon alpha therapy on cellular immune parameters. Absolute change following two cycles of therapy.|at two months from start of treatment|Patients that received treatment||participants|||Number
822834|NCT01158534|Secondary|Progression-free Survival|Progression-free survival measured in months and summarized using the Kaplan-Meier method. Time to objective progression will be measured from the start of treatment until the criteria for progression are met, taking as reference the smallest measurements recorded since the treatment started, including baseline.|to progression|||months||95% Confidence Interval|Median
822835|NCT01158534|Secondary|Duration of Response|The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started, including baseline). The duration of overall CR is measured from the time measurement criteria are first met for CR until the first date that recurrent disease is objectively documented.|end of study|Patients who achieved at least a partial response||months||Full Range|Median
822836|NCT01158534|Secondary|Overall Survival|Overall survival measured in months and summarized using the Kaplan-Meier method.|death|||months||95% Confidence Interval|Median
822837|NCT01158534|Primary|Objective Response Rate Assessed by RECIST Criteria.|The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started, including baseline). The patient's best response assignment will depend on the achievement of both measurement and confirmation criteria. Objective response will be assessed by RECIST criteria.|at week 4 of cycle 2 and every other cycle thereafter|||participants|||Number
822838|NCT01158703|Secondary|Number of Thrombotic Events|Number of thrombotic events with combination therapy with aspirin and clopidogrel vs. aspirin alone|52 weeks|above is the total number of participants||thrombotic Events over 52Wks|||Number
822839|NCT01158703|Secondary|Number of Myocardial Infarction Events|Number of myocardial infarction events with combination therapy with aspirin and clopidogrel vs. aspirin alone|52 weeks|above is the total number of participants||MI Events over 52Wks|||Number
822840|NCT01158703|Secondary|Number of Angina Events|Number of angina events with combination therapy with aspirin and clopidogrel vs. aspirin alone|52 weeks|above is the total number of participants||Angina Events over 52Wks|||Number
822841|NCT01158703|Secondary|Number of Major Adverse Cardiovascular Events With Combination Therapy|Number of major adverse cardiovascular events(angina, any thrombotic events, and myocardial infarction) with combination therapy with aspirin and clopidogrel vs. aspirin alone|52 weeks|above is the total number of all events reported||MACE Events over 52Wks|Participants||Number
822842|NCT01158703|Secondary|Incidence of Bleeding Between the Two Treatment Arms||52 weeks|||BLEEDING EVENTS|||Number
822843|NCT01158703|Primary|Incidence of More Than 50% Stenosis in Graft With Combination Therapy With Aspirin and Clopidogrel vs. Aspirin Alone|Incidence of more than 50% stenosis in graft with combination therapy with aspirin and clopidogrel vs. aspirin and placebo|52 weeks|Incidence of more than 50% stenosis in graft with combination therapy with aspirin and clopidogrel vs. aspirin and placebo||occluded grafts|Participants||Number
822844|NCT01158716|Secondary|ECG Evidence of Ischemia During Coronary Balloon Occlusion|ST-segment deviation as monitored during coronary balloon occlusion|During coronary balloon occlusion||||||
822845|NCT01158716|Secondary|Chest Pain During Coronary Balloon Occlusion|Chest pain severity was assessed with a 10 point scale (0: no pain, 10: most severe discomfort ever experienced)|During coronary balloon occlusion||||||
822846|NCT01158716|Primary|Delta Cardiac Troponin I (ΔcTnI)|ΔcTnI is defined as cardiac troponin I (cTnI) at 24 hours post-PCI minus cTnI before coronary angiography|24 hours post PCI|||ng/mL||Inter-Quartile Range|Median
822847|NCT01158924|Secondary|Change in Physical Component Summary of Quality of Life Measure Assessed by Short-Form 36 at 12 Months From Baseline.|The 36-item Short Form Health Survey (SF-36) is a patient reported outcome survey that evaluates functional health and well-being. The survey is converted into two summary measures (the Physical Component - PCS and Mental Component- MCS) that are scored from 0 to 100 (where 100 indicates the highest level of health).|12 Months|FAS Population||units on a scale||Standard Deviation|Mean
822848|NCT01158924|Secondary|Change in Pain Visual Analog Scale (VAS) at 12 Months From Baseline.|The Visual Analog Scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line (that is approximately 10 cm long) with 'No Pain' (score of 0 = 0 cm) listed on the left and 'Very severe pain' (score of 10=10cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their back.|12 months|FAS Population||units on a scale||Standard Deviation|Mean
822850|NCT01158924|Secondary|Change in Function Assessed by Oswestry Disability Index Change at 12 Months From Baseline|The Oswestry Disability Index (ODI) is a 10-category (Pain Intensity, Personal Care, Lifting, Walking, Sitting, Standing, Sleeping, Sex Life, Social Life, Traveling) disability measurement scale with a graded response from 0 to 5, with 0 being the best score (no impairment) to 5 being the worst score (significant impairment). ODI score for a subject is calculated by adding the scores and converting the score to a 100 point scale.|12 months|FAS Population||units on a scale||Standard Deviation|Mean
822851|NCT01158924|Primary|Neurological Assessment for Motor Function and Reflexes/Sensory|"Neurological Assessment for Motor Function and Reflexes/Sensory- Number of patients with Clinically Significant Abnormal results at 12 months.
For Motor Function, Clinically Significant Abnormal results are determined by the surgeon investigator and are further classified by grade: 0= No Movement, 1= Flicker/trace of contraction, 2=Active movement when gravity removed, 3= Active movement against gravity, 4= Active Movement against gravity and resistance.
For Reflexes/Sensory, Clinically Significant Abnormal results are determined by the surgeon investigator and are based on exams of the Knee, Ankle, L3-L5 Dermatone, and S1 Dermatome. Tension signs are evaluated with a straight leg raise to determine at which point, if any, sciatic pain occurs."|12 months|"Safety Population
The Neurological Assessment at 12 months was only conducted on 13 subjects from the 1.0mg group (out of 14 total subjects) and 25 subjects from the 2.0 mg group (out of 26 total)."||participants|||Number
822852|NCT01159054|Secondary|Number of Completed Subjects With Significant Increase in ALT (Alanine Aminotransferase).|The number of subjects with significant rise in ALT but not to the extent requiring removal from the study (rise to more than 3 times the upper limit of the normal range)|6 months (checked monthly)|||Participants|||Number
822853|NCT01159054|Secondary|Hemodialysis Access Stenosis/Thrombosis|Comparison of the average hemodialysis access stenosis/thrombosis requiring intervention in the 3 month before and the last 3 months of the study.|6 months|Data for this outcome measure was not collected from the medical record due to early termination of the study.|||||
822854|NCT01159054|Secondary|Rate of Cardiovascular Events|Comparison of the average major cardiovascular events (myocardial infarction and/or stroke) in the 3 month before and the last 3 months of the study.|6 months|Data for this outcome measure was not collected from the medical record due to early termination of the study.|||||
822855|NCT01159054|Secondary|Hemoglobin Level|Pre and Post Levels|6 months|Only 2 subjects completed the study. Further analysis was not done because power was not met.||g/dL||Full Range|Mean
822856|NCT01159054|Secondary|ESA (Erythorpoietic Stimulating Agent) Dose Requirement|Comparison of the average ESA dose used in the 3 month before and the last 3 months of the study.|6 months|Data for this outcome measure was not collected.|||||
822857|NCT01159054|Secondary|Albumin Level|Pre and Post levels.|6 months|Only 2 subjects completed the study. Further analysis was not done because power was not met.||g/dL||Full Range|Mean
822858|NCT01159054|Primary|Changes in IL-6 Level|Change in IL-6 level before and after treatment in each subject|6 months|Only 2 subjects completed the study. Further analysis not done because power was not met.||pg/mL||Full Range|Mean
822859|NCT01159054|Primary|Changes in Hs-CRP Level|Change in hs-CRP level before and after treatment in each subject|6 months|Only 2 subjects completed the study. Power for further analysis was not met.||mg/L||Full Range|Mean
822860|NCT01159054|Primary|Changes in FDG-PET/CT Dual Scan Score||6 months|Analysis of images for this outcome measure was not done given than only 2 subjects had completed the study at the time of the study early termination and closure (per funding source)|||||
822861|NCT01159171|Secondary|Overall Survival|OS was defined as the time in months from Day 1 until the date of death due to any cause. Data for participants who were alive at the end of the study were censored at the date of the last available follow-up visit. Mean OS was estimated using the Kaplan-Meier method.|Baseline, monthly to end of study (up to 24 months)|ITT Population||months||Standard Deviation|Mean
822862|NCT01159171|Secondary|Overall Survival (OS) - Percentage of Participants With an Event by 24 Months|OS was defined as the time in months from Day 1 until the date of death due to any cause. Data for participants who were alive at the end of the study were censored at the date of the last available follow-up visit.|Baseline, monthly to end of study (up to 24 months)|ITT Population||percentage of participants|||Number
822863|NCT01159171|Secondary|Time to Progression|TTP was defined as the time in months from Day 1 until the date of first documented progressive disease, or death due to any cause. Data for participants who were alive without disease progression at the end of study, or who were non-responder participants (without tumor assessment after baseline) were censored at Day 1. Mean TTP was estimated using the Kaplan-Meier method.|Baseline, monthly to end of study (up to 24 months)|ITT Population||months||Standard Deviation|Mean
822864|NCT01159171|Secondary|Time to Progression (TTP) - Percentage of Participants With an Event by 24 Months|TTP was defined as the time time in months from Day 1 until the date of first documented progressive disease, or death due to any cause. Data for participants who were alive without disease progression at the end of study, or who were non-responder participants (without tumor assessment after baseline) were censored at Day 1.|Baseline, monthly to end of study (up to 24 months)|ITT Population||percentage of participants|||Number
822865|NCT01159171|Secondary|Time to Treatment Failure|TTF was defined as the time in months from Day 1 until discontinuation of treatment for any reasons. These reasons included: death due to any cause, treatment toxicity (adverse event), insufficient therapeutic response (progression of disease), failure to return (lost to follow-up), refusing treatment (participant non-compliance), being unwilling to cooperate and withdrawing consent (participant withdrew consent). Mean TTF was estimated using the Kaplan-Meier method.|Baseline, monthly to end of study (up to 24 months)|ITT Population||months||Standard Deviation|Mean
822866|NCT01159171|Secondary|Time to Treatment Failure (TTF) - Percentage of Participants With an Event by 24 Months|TTF was defined as the time in months from Day 1 until discontinuation of treatment for any reasons. These reasons included: death due to any cause, treatment toxicity (adverse event), insufficient therapeutic response (progression of disease), failure to return (lost to follow-up), refusing treatment (participant non-compliance), being unwilling to cooperate and withdrawing consent (participant withdrew consent).|Baseline, every month to end of treatment (up to 24 months)|ITT Population||percentage of participants|||Number
822929|NCT01165775|Secondary|Neonatal Hypoglycemia||birth to discharge|Neonates from birth to discharge. The maternal patients received betamethasone to minimize the complications of prematurity. Maternal blood glucose levels were monitored using the Dexcom Seven Plus Continuous Glucose Monitoring System.||participants|||Number
822867|NCT01159171|Secondary|Duration of Stable Disease|Duration of stable response (CR, PR, or SD) was calculated only for participants of the ITT population whose best overall response was CR, PR, or SD based on RECIST criteria. Duration of overall response was defined as the time from the date of the first assessment of CR, PR, or SD status until the date of progression or death. Data for participants who were alive without any objectively documented disease progression at the end of the study were censored as of the date of last contact. Mean time to event was estimated using the Kaplan-Meier method.|Baseline, every 3 months to progression of disease or end of study (up to 24 months)|ITT Population: only participants with a best overall response of CR, PR, or SD were included in the analysis.||months||Standard Deviation|Mean
822868|NCT01159171|Primary|Percentage of Participants by Best Overall Response|Best response recorded from the start of treatment until disease progression. Based on assessment of CR, PR, stable disease (SD), or progressive disease (PD), according to RECIST. CR: disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR: ≥30% decrease under baseline of the sum of the LD diameters of all target lesions. CR and PR persist on repeat imaging study at least 4 weeks after initial documentation. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Reference is the smallest sum LD. PD: at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum longest diameter recorded or the appearance of one or more new lesions.|Baseline, every 3 months to progression of disease or end of study (up to 24 months)|ITT Population. 5 participants were not assessed as they did not reach the 3 month time-point.||percentage of participants|||Number
822869|NCT01159171|Secondary|Duration of Stable Disease - Percentage of Participants With an Event by 24 Months|Duration of stable response (CR, PR, or stable disease [SD]) was calculated only for participants of the ITT population whose best overall response was CR, PR, or SD based on RECIST criteria. Duration of overall response was defined as the time from the date of the first assessment of CR, PR, or SD status until the date of progression or death. Data for participants who were alive without any objectively documented disease progression at the end of the study were censored as of the date of last contact.|Baseline, every 3 months to progression of disease or end of study (up to 24 months)|ITT Population; only participants with a best overall response of CR, PR, or SD were included in the analysis.||percentage of participants|||Number
822870|NCT01159171|Secondary|Duration of Response|Duration of overall response (CR or PR) was calculated for participants of the ITT population whose best overall response was CR or PR based on RECIST criteria. Duration of overall response was defined as the time from the date of the first assessment of CR or PR status until the date of progression or death. Data for participants who were alive without any objectively documented disease progression at the end of the study were censored as of the date of last contact. Mean time to event was estimated using the Kaplan-Meier method.|Baseline, every 3 months to progression of disease or end of study (up to 24 months)|ITT Population; only participants with a best overall response of CR or PR were included in the analysis.||months||Standard Deviation|Mean
822871|NCT01159171|Secondary|Duration of Response - Percentage of Participants With an Event by 24 Months|Duration of overall response (CR or PR) was calculated only for participants of the ITT population whose best overall response was CR or PR based on RECIST criteria. Duration of overall response was defined as the time from the date of the first assessment of CR or PR status until the date of progression or death. Data for participants who were alive without any objectively documented disease progression at the end of the study were censored as of the date of last contact.|Baseline, every 3 months to progression of disease or end of study (up to 24 months)|ITT population; only participants with a best overall response of CR or PR were included in the analysis.||percentage of participants|||Number
822872|NCT01159171|Primary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR was defined as the percentage of participants who achieved complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR was defined as greater than or equal to (≥)30 percent (%) decrease under baseline of the sum of the longest diameter (LD) diameters of all target lesions. No unequivocal progression of non-target disease. No new lesions. Complete and partial responses must have been confirmed no less than 4 weeks after the criteria for response were first met.|Baseline, every 3 months to progression of disease or end of study (up to 24 months)|Intent to Treat (ITT) Population: all participants who signed the informed consent, were assigned a study patient number, and who were administered at least 1 dose of 1 study medication.||percentage of participants|||Number
822873|NCT01159262|Secondary|Time to Successful Extubation in DEX-exposed Subjects||From start of DEX administration to extubation of each subject up to 7 days post-infusion|Efficacy Evaluable Population: All subjects who received randomized Dexmedetomidine for at least 6 hours.||hour||95% Confidence Interval|Median
822874|NCT01159262|Secondary|Weight-adjusted Total Amount (Per kg) of Rescue Medication Morphine Given for Analgesia During Dexmedetomidine Infusion (Among Who Used)||During study drug administration (6 to 24 hours)|All subjects who received morphine during Dexmedetomidine infusion||milligram/Kg||Standard Deviation|Mean
822875|NCT01159262|Secondary|Weight-adjusted Total Amount (Per kg) of Rescue Medication Fentanyl Given for Analgesia During Dexmedetomidine Infusion (Among Who Used)||During study drug administration (6 to 24 hours)|All subjects who received fentanyl during Dexmedetomidine infusion||microgram/Kg||Standard Deviation|Mean
822876|NCT01159262|Secondary|Weight-adjusted Total Amount (Per kg) of Rescue Medication Midazolam Given for Sedation During Dexmedetomidine Infusion (Among Who Used)||During study drug administration (6 to 24 hours)|All subjects who received midazolam during Dexmedetomidine infusion||milligrams/Kg||Standard Deviation|Mean
822877|NCT01159262|Secondary|Total Amount of Rescue Medication Morphine Given for Sedation During Dexmedetomidine Infusion (Among Who Used)||During study drug administration (6 to 24 hours)|All subjects who received morphine during Dexmedetomidine infusion||milligram||Standard Deviation|Mean
822878|NCT01159262|Secondary|Total Amount of Rescue Medication Fentanyl Given for Sedation During Dexmedetomidine Infusion (Among Who Used)||During study drug administration (6 to 24 hours)|All subjects who received fentanyl during Dexmedetomidine infusion||Microgram||Standard Deviation|Mean
822879|NCT01159262|Secondary|Total Amount of Rescue Medication Midazolam Given for Sedation During Dexmedetomidine Infusion (Among Who Used)||During Study drug administration (6 to 24 hours)|All subjects who received midazolam during Dexmedetomidine infusion||Milligram||Standard Deviation|Mean
822882|NCT01159431|Secondary|Mood|Mean change in score on the Beck Depression Inventory. The Beck Inventory is a patient reported mood scale. The minimum score is 0, and the maximum score is 63. Scores of less than 10 are considered in the normal range. Scores above 10 are consistent with depression. Higher scores indicate higher degrees of depression, with scores of > 25 consistent with severe depression.|18-weeks|||units on a scale||Standard Deviation|Mean
822883|NCT01159431|Primary|Change in Seizure Frequency|Percent change in seizure frequency from baseline|18 weeks|||percentage change in seizures per month||Standard Deviation|Median
822884|NCT01159431|Secondary|Response Ratio: Mean Percent Change in Seizures|Response Ratio: Mean Percent Change in seizures over the treatment period, where [T-B] / [T+B] x 100%, where T = seizure frequency during the treatment period, and B = seizure frequency during the baseline period.|18 weeks|||percentage change of RRATIO||Standard Deviation|Mean
822885|NCT01159431|Primary|Time to the 4th Seizure|Number of Days to the 4th seizure|treatment period (18-weeks)|||days||Standard Deviation|Mean
822886|NCT01159431|Primary|50% Responder Rate|"Change in responder rate, at end of study (18 weeks)
Absolute percent of subjects with 50% reduction in seizures, 18 weeks compared with 6 weeks Note, the number is not a mean or median, but a fixed percentage."|Treatment period, 18 weeks (end of double blind period) compared with first 6 weeks|||percentage of participants|||Number
822887|NCT01159535|Primary|Mean Number of Alcohol and Drug Use Days Out of Past 30|Self reported use of alcohol and or illicit substances over the previous 30 days|30 days previous, assessed at 12-month follow-up|||number of days out of past 30||Standard Deviation|Mean
822888|NCT01159574|Secondary|Time to Disease Progression (Progression Free Survival)||From start of treatment, to date of disease progression|18 patients were removed from study for reasons other then disease progression; 2 patients are still receiving treatment.||days||Full Range|Mean
822889|NCT01159574|Secondary|Time to Maximum Response, Expressed as Number of Cycles of Treatment to Maximum Response||From baseline to cycle of maximum response, which occurred on average after 2 cycles; 1 cycle = 28 days|||cycles||Full Range|Mean
822890|NCT01159574|Primary|Overall Response Rate|Best response rate was recorded for all patients, using the IMWG criteria.|from baseline to cycle with maximum response, which was achieved on average after 2 cycles|||Participants|||Count of Participants
822891|NCT01159600|Other Pre-specified|Confirmed Hypoglycaemic Adverse Events|Number of patients with confirmed hypoglycaemic events, as reported as adverse events.|From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days|"Treated set, which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken.
Open label set which included all patients entered into the open-label arm."||percentage of participants|||Number
822892|NCT01159600|Primary|HbA1c Change From Baseline|"Change from baseline in HbA1c after 24 weeks.
For open-label groups the descriptive mean is provided, for randomised groups adjusted means are provided. The means are adjusted separately for metformin alone and metformin plus sulphonylurea background medication."|Baseline and 24 weeks|"Full analysis set. Treatment assignment as randomised.
Open-label analysis: Open-label set which included all patients entered in the empa 25mg open-label treatment arm.
Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values."||percentage of HbA1c||Standard Error|Mean
822893|NCT01159600|Secondary|Mean Daily Plasma Glucose (MDG) Change From Baseline|"Change from baseline in mean daily glucose (MDG) using the 8-point blood glucose profile, after 24 weeks of treatment.
For open-label groups the descriptive mean is provided, for randomised groups adjusted means are provided. The means are adjusted separately for metformin alone and metformin plus sulphonylurea background medication."|Baseline and 24 weeks|"Full analysis set. Treatment assignment as randomised.
Open-label analysis: Open-label set which included all patients entered in the empa 25mg open-label treatment arm.
Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values."||mg/dL||Standard Error|Mean
822894|NCT01159600|Secondary|Body Weight Change From Baseline|"Body weight change from baseline after 24 weeks.
For open-label groups the descriptive mean is provided, for randomised groups adjusted means are provided. The means are adjusted separately for metformin alone and metformin plus sulphonylurea background medication."|Baseline and 24 weeks|"Full analysis set. Treatment assignment as randomised.
Open-label analysis: Open-label set which included all patients entered in the empa 25mg open-label treatment arm.
Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values."||kg||Standard Error|Mean
822895|NCT01159665|Other Pre-specified|Time Necessary to Remove the Vitreous From the Eye|PPV was performed in all subjects. The time necessary to remove the vitreous from the eye, measured from first start of vitrectomy cutter till end of core vitrectomy phase, was calculated.|From first start of vitrectomy cutter till the end of core vitrectomy phase|Safety Set||Minutes||Standard Deviation|Mean
822896|NCT01159665|Primary|Ocriplasmin Activity Levels in Vitreous Samples Obtained at the Beginning of Vitrectomy.|Vitreous samples were obtained at the beginning of vitrectomy in subjects at various times relative to ocriplasmin injection (post-injection), for the determination of ocriplasmin activity (Group 1 [5-30 minutes]; Group 2 [31-60 minutes]; Group 3 [2-4 hours]; Group 4 [24 hours ±2 hours]; Group 5 [7 days ±1 day]. Subjects in Group 6 (control) did not receive the ocriplasmin injection.|5-30 minutes, 31-60 minutes, 2-4 hours, 1 day, or 7 days after ocriplasmin injection|Safety Set. Values for the PPV 7 days (+1 day) after injection and for PPV without injection treatment groups were all < Lower Limit of Quantification (LLOQ)||ng/mL||Standard Deviation|Mean
822897|NCT01159691|Primary|Assessment of Patient Satisfaction Referring to Gastrointestinal (GI) Complaints Following Treatment Switch to Neupro® at Visit 3|"Patient satisfaction referring to GI complaints is classified into 5 categories:
Missing
Very satisfied
Satisfied
Moderately satisfied
Not satisfied."|At Visit 3 (after approximately 6 weeks)|All of the 65 subjects in the Full Analysis Set are included in this analysis.||participants|||Number
822898|NCT01159691|Primary|Assessment of Patient Satisfaction Referring to Gastrointestinal (GI) Complaints Following Treatment Switch to Neupro® at Visit 2|"Patient satisfaction referring to GI complaints is classified into 5 categories:
Missing
Very satisfied
Satisfied
Moderately satisfied
Not satisfied."|At Visit 2 (after approximately 2-4 weeks)|All of the 65 subjects in the Full Analysis Set are included in this analysis.||participants|||Number
822899|NCT01159691|Primary|Change From Baseline to Visit 3 in the Sum Score of Gastrointestinal (GI) Complaints|"Sum score of GI complaints was calculated from frequency and intensity of the complaints. The intensity of GI complaints during the last week ranges from 0 (no complaints) to 3 (severe) and the frequency of these complaints during the last week ranges from 0 (never) to 4 (every day).
For each of the seven GI complaints assessed at a visit (swallowing disorders, heartburn, feeling of fullness, nausea, vomiting, abdominal pain, and diarrhea), intensity and frequency were multiplied to achieve individual item scores of GI complaints (range: 0 – 12).
Finally, the sum score of GI complaints per visit was calculated by accumulating 6 of the 7 item scores (excluding swallowing disorders, which was recorded at Baseline only) for patients with valid values in each score (range: 0 – 72). Negative values indicate an improvement from Baseline to Visit 3 with larger negative values showing a better improvement."|From Baseline to Visit 3 (approximately 6 weeks)|Of the 65 subjects in the Full Analysis Set, 58 are included in this analysis.||units on a scale||Standard Deviation|Mean
822900|NCT01159691|Primary|Change From Baseline to Visit 3 in the Assessment of Intensity of Gastrointestinal (GI) Complaints for Any Reason as Per Visual Analogue Scale (VAS)|Patients were asked to classify the intensity of their GI complaints on a scale ranging from 0 (no complaints) to 100 (extremely severe complaints). Negative values indicate an improvement from Baseline to Visit 3 with larger negative values showing a better improvement.|From Baseline to Visit 3 (approximately 6 weeks)|Of the 65 subjects in the Full Analysis Set, 58 are included in this analysis.||millimeter (mm)||Standard Deviation|Mean
822901|NCT01159743|Secondary|Change Over Time in Body Fat Distribution|"Change over time in total body fat and fat in the limbs and trunk was assessed by dual X-ray absorptiometry (DEXA) in participants for whom a DEXA measurement performed at least 6 months before participation in this study was available.
A negative change score indicates fat loss over time and a positive change score indicates fat gain over time."|DEXA performed at the study visit and more than 6 months prior to the study visit (the period of time between the DEXA recorded at the study visit and the previous DEXA ranged from 6 to 36 months).|Participants for whom a dual X-ray absorptiometry measurement performed at least 6 months before participation in this study was available.||kg||Standard Deviation|Mean
822902|NCT01159743|Secondary|Lipodystrophy Severity Grading Scale (LSGS) Scores|"Perception of body fat was assessed by the Lipodystrophy Severity Grading Scale (LSGS), a standardized measurement of subjective lipoatrophy (fat loss) and lipoaccumulation (fat gain) perceived by the participant and by the physician. The degree of lipoatrophy and diffuse fat accumulation at each region was rated by both the participant and the physician as: Score 0=absent; Score 1=mild or noticeable on close inspection; Score 2=moderate or readily noticeable by patient/physician; Score 3=severe or readily noticeable to a casual observer.
Score A reflects the lipoatrophy or fat loss perception at the face, arms, buttocks and legs and ranges from 0-12.
Score B reflects the perception of fat gain at the abdomen, neck, and breasts and ranges from 0-9.
The overall score is the sum of the scores A+B, and ranges from 0-21.
Higher numbers indicate more fat loss (Score A) or gain (Score B). An average overall patient/physician score >7 indicates a clinical diagnosis of lipodystrophy."|Study visit|"All participants for whom data were available. The number of participants included in the analysis of each score for each group of participants is shown as N (EFV and then LPV/r)."||units on a scale||Standard Deviation|Mean
822903|NCT01159743|Secondary|Distribution of Body Fat Mass|Body fat mass was assessed by dual energy X-ray absorptiometry (DEXA) scan.|Study visit|"All participants for whom data were available. The number of participants included in the analysis of each category for each group of participants is shown as N (EFV and then LPV/r)."||kg||Standard Deviation|Mean
822904|NCT01159743|Primary|Total Limb Fat Mass|Total limb fat mass was assessed by dual energy X-ray absorptiometry (DEXA) scan. DEXA uses a whole body scanner and two different low-dose x-rays to read bone mass and soft tissue mass.|Study visit|All participants for whom data were available.||kg||Standard Deviation|Mean
822905|NCT01159769|Primary|Overall Patient Satisfaction|"Overall satisfaction was assessed by the patient on a questionnaire. The patient was instructed to select a single response to the statement, Overall, how satisfied were you with olopatadine 0.2%? A 5-point scale was used: very satisfied, satisfied, undecided, dissatisfied, very dissatisfied. Results are reported as the percentage of patients who responded, very satisfied or satisfied."|Day 7|All subjects who used the study medication at least once (intent to treat).||Percentage of Participants|||Number
822906|NCT01159769|Primary|Overall Patient Satisfaction|"Overall satisfaction was assessed by the patient on a questionnaire. The patient was instructed to select a single response to the statement, Overall, how satisfied are you with your current eye allergy medication? A 5-point scale was used: very satisfied, satisfied, undecided, dissatisfied, very dissatisfied. Results are reported as the percentage of patients who responded, very satisfied or satisfied."|Day 0|All subjects who used the study medication at least once (intent to treat).||Percentage of Participants|||Number
822907|NCT01159912|Secondary|Change From Baseline in the Total Asthma Quality of Life Questionnaire (AQLQ) (+12) Score at Week 12 and Week 24|"The AQLQ is a disease-specific, self-administered quality of life questionnaire used to evaluate the impact of asthma treatments on the quality of life of asthma sufferers. The AQLQ for 12 years and older (AQLQ [+12]) is a modified version of the AQLQ for use in asthma patients between the ages of 12 and 70. The AQLQ contains 32 items in 4 domains: activity limitation (11 items), symptoms (12 items), emotional function (5 items), and environmental stimuli (4 items). For the 32 items on the questionnaire, the response format consists of a seven-point scale, where a value of 1 indicates “total impairment” and a value of 7 indicates “no impairment.” The AQLQ total score is defined as the average of the scores from all 32 questions; thus, the total score ranges from 1 (indicates total impairment) to 7 (indicates no impairment). Baseline was the total score obtained at Visit 3. Change from Baseline was calculated as the total score at Weeks 12 and 24 minus the total score at Baseline."|Baseline, Week 12, and Week 24|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Scores on a scale||Standard Error|Least Squares Mean
822930|NCT01165775|Primary|Percentage Time Spent Above Glucose Thresholds (>110;>144;>180) 24-48 Hours Post Betamethasone Treatment|During a 24 hour monitoring period (24-48 hours post betamethasone treatment), which percentage of the time was spent above glucose thresholds (>110;>144;>180)|24-48 hours post betamethasone treatment|Seventeen women were enrolled at the time of betamethasone administration and data were available for 15 patients.||percentage time||Standard Deviation|Mean
822908|NCT01159912|Secondary|Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods at the End of the 24-week Treatment Period|The number of inhalations of rescue bronchodilator, albuterol/salbutamol inhalation aerosol, used during the day and night was recorded by the participants in a daily electronic diary (eDiary). Similarly, asthma symptoms were recorded in a daily eDairy by the participants every day in the morning and evening before taking any rescue or study medication and before the peak expiratory flow measurement. A 24-hour period in which a participant’s responses to both the morning and evening assessments indicated no symptoms was considered to be symptom free. The Baseline value was derived from the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|Baseline and Week 24|ITT Population. Only those participants available at the specified time points were analyzed.||Percentage of symptom-free 24-hr periods||Standard Error|Least Squares Mean
822909|NCT01159912|Secondary|Mean Change From Baseline in Daily Morning (AM) PEF Averaged Over the First 12 Weeks and 24 Weeks of the 24-week Treatment Period|PEF is a measure of lung function and is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning and evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline (defined as the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily AM PEF over 12 weeks and 24 weeks of the 24-week Treatment Period (at Weeks 12 and 24) minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|From Baseline up to Week 12 and Week 24|ITT Population. Only those participants available at the specified time points were analyzed.||Liters/minute (L/min)||Standard Error|Least Squares Mean
822910|NCT01159912|Secondary|Mean Change From Baseline in Daily Trough Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the First 12 Weeks and 24 Weeks of the 24-week Treatment Period|PEF is a measure of lung function and is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning and evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Trough evening PEF is the PM PEF measured approximately 24 hours after the last evening administration of study drug. Change from Baseline (defined as the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily trough PM PEF over 12 weeks and 24 weeks of the 24-week Treatment Period (at Weeks 12 and 24) minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|From Baseline up to Week 12 and Week 24|ITT Population. Only those participants available at the specified time points were analyzed.||Liters/minute (L/min)||Standard Error|Least Squares Mean
822911|NCT01159912|Secondary|Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods at the End of the 24-week Treatment Period|The number of inhalations of rescue bronchodilator, albuterol/salbutamol inhalation aerosol, used during the day and night was recorded by the participants in a daily electronic diary (eDiary). Similarly, asthma symptoms were recorded in a daily eDairy by the participants every day in the morning and evening before taking any rescue or study medication and before the peak expiratory flow measurement. A 24-hour period in which a participant’s responses to both the morning and evening assessments indicated no use of rescue medication was considered to be rescue free. The Baseline value was derived from the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|Baseline and Week 24|ITT Population. Only those participants available at the specified time points were analyzed.||Percentage of rescue-free 24-hr periods||Standard Error|Least Squares Mean
822912|NCT01159912|Primary|Mean Change From Baseline in Clinic Visit Trough Evening (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 24 Week Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is defined as the clinic visit (pre-bronchodilator and pre-dose) FEV1 measurement taken at the clinic visit at the end of the dosing interval. Pre-dose and pre-rescue albuterol/salbutamol trough FEV1 was measured electronically by spirometry in the evening at the Baseline through Week 24 clinic visits. The highest of 3 technically acceptable measurements was recorded. Baseline was the pre-dose value obtained at Visit 2. Change from Baseline was calculated as the Week 24 value minus the Baseline value. Analysis was performed using analysis of covariance (ANCOVA) with covariates of Baseline, region, sex, age, and treatment. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement at scheduled clinic visits was used to impute the missing measurements.|Baseline and Week 24|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study medication. Only those participants with non-missing covariates and a post-Baseline FEV1 measurement were analyzed.||Liters||Standard Error|Least Squares Mean
822913|NCT01159938|Secondary|Change in Postprandial Pulse Wave Velocity (PWV)|The PWV measured arterial stiffness in the aortic and brachial arteries of healthy participants and T2DM participants. Changes in PWV from baseline [30-minute (min) pre-breakfast] are reported.|30 mins (pre-breakfast), 60, 120, 180 and 240 mins (post-breakfast)|Enrolled healthy and randomized type 2 diabetes mellitus (T2DM) participants who had a baseline and post-baseline PWV measurement at specified time point and no major protocol deviation.||meters per second (m/sec)||Standard Deviation|Mean
822914|NCT01159938|Secondary|Change in Blood Glucose (BG)|Changes in BG from the baseline [30-minute (min) pre-breakfast] are reported.|30 mins (pre-breakfast), 50, 110 ,170, and 230 mins (post-breakfast)|Enrolled healthy and randomized type 2 diabetes mellitus (T2DM) participants who had a baseline and a post-baseline blood glucose measurement at specified time point and no major protocol deviation.||millimoles per liter (mmol/L)||Standard Deviation|Mean
822932|NCT01165983|Secondary|Absolute Change in Inflammatory Cytokines and Growth Factors, TNFα, pg/mL||12 Weeks post-randomization|||pg/mL||Inter-Quartile Range|Median
822933|NCT01165983|Secondary|Absolute Change in Inflammatory Cytokines and Growth Factors, sCD-40L ng/mL||12 Weeks post-randomization|||ng/mL||Inter-Quartile Range|Median
822915|NCT01159938|Secondary|Change in QT Interval on Electrocardiogram (ECG)|QT interval is a measure of time from the beginning of the QRS complex to the end of the T wave on an ECG during which contraction of the ventricles occurs. Changes in QT interval from baseline [30-minute (min) pre-breakfast] are reported.|30 mins (pre-breakfast), 60, 120, 180 and 240 mins (post-breakfast)|Enrolled healthy and randomized type 2 diabetes mellitus (T2DM) participants who had a baseline and a post-baseline QT interval measurement at specified time point and no major protocol deviation.||milliseconds (msec)||Standard Deviation|Mean
822916|NCT01159938|Secondary|Change in Peripheral Artery Tonometry (PAT)|The PAT device is a pneumatic plethysmograph that applies uniform pressure to the surface of each finger tip and measures digital pulse amplitude. The PAT was reported as a percentage of pulse amplitude and expressed as the ratio of post deflation to baseline pulse amplitude in hyperemic finger divided by the same ratio in the contralateral finger that served as a control. The change in PAT from baseline [30-minute (min) pre-breakfast] is reported.|30 mins (pre-breakfast), 120 and 240 mins (post-breakfast)|Enrolled healthy and randomized T2DM participants who had a baseline and a post-baseline PAT measurement at specified time point and no major protocol deviation.||percentage of pulse amplitude||Standard Deviation|Mean
822917|NCT01159938|Secondary|Change in Pulse Wave Amplitude (PWA)|The PWA measured systemic arterial stiffness (augmentation index). PWA was reported as a percentage of systolic peak and calculated as the difference between second and first systolic peak in an ascending aortic pulse pressure waveform divided by the first systolic peak then multiplied by 100. The change in PWA from baseline [30-minute (min) pre-breakfast] is reported.|30 mins (pre-breakfast), 60, 120, 180 and 240 mins (post-breakfast)|Enrolled healthy and randomized type 2 diabetes mellitus (T2DM) participants with a baseline and a post-baseline PWA measurement at specified time point and no major protocol deviation.||percentage of systolic peak||Standard Deviation|Mean
822918|NCT01159938|Primary|Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 240 Minutes (Mins) Post-Breakfast|The PWV measured arterial stiffness in the aortic and brachial arteries of T2DM participants. The Least Square (LS) mean was estimated from a mixed-effect analysis of covariance (ANCOVA) model that was adjusted for age, body mass index (BMI), visit, group, condition, group by condition, and random participant.|240 mins (post-breakfast)|Randomized T2DM participants who received study drug and had a post-baseline PWV measurement at the specified time point and no major protocol deviation.||meters per second (m/sec)||95% Confidence Interval|Least Squares Mean
822919|NCT01159938|Primary|Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 180 Minutes (Mins) Post-Breakfast|The PWV measured arterial stiffness in the aortic and brachial arteries of T2DM participants. The Least Square (LS) mean was estimated from a mixed-effect analysis of covariance (ANCOVA) model that was adjusted for age, body mass index (BMI), visit, group, condition, group by condition, and random participant.|180 mins (post-breakfast)|Randomized T2DM participants who received study drug and had a post-baseline PWV measurement at the specified time point and no major protocol deviation.||meters per second (m/sec)||95% Confidence Interval|Least Squares Mean
822920|NCT01159938|Primary|Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 120 Minutes (Mins) Post-Breakfast|The PWV measured arterial stiffness in the aortic and brachial arteries of T2DM participants. The Least Square (LS) mean was estimated from a mixed-effect analysis of covariance (ANCOVA) model that was adjusted for age, body mass index (BMI), visit, group, condition, group by condition, and random participant.|120 mins (post-breakfast)|Randomized T2DM participants who received study drug and had a post-baseline PWV measurement at the specified time point and no major protocol deviation.||meters per second (m/sec)||95% Confidence Interval|Least Squares Mean
822921|NCT01159938|Primary|Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 60 Minutes (Mins) Post-Breakfast|The PWV measured arterial stiffness in the aortic and brachial arteries of T2DM participants. The Least Square (LS) mean was estimated from a mixed-effect analysis of covariance (ANCOVA) model that was adjusted for age, body mass index (BMI), visit, group, condition, group by condition, and random participant.|60 mins (post-breakfast)|Randomized T2DM participants who received study drug and had a post-baseline PWV measurement at the specified time point and no major protocol deviation.||meters per second (m/sec)||95% Confidence Interval|Least Squares Mean
822922|NCT01159938|Primary|Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 30 Minutes (Mins) Pre-Breakfast|The PWV measured arterial stiffness in the aortic and brachial arteries of T2DM participants. The Least Square (LS) mean was estimated from a mixed-effect analysis of covariance (ANCOVA) model that was adjusted for age, body mass index (BMI), visit, group, condition, group by condition, and random participant.|30 mins (pre-breakfast)|Randomized T2DM participants who were scheduled to receive study drug and had a baseline PWV measurement at the specified time point and no major protocol deviation.||meters per second (m/s)||95% Confidence Interval|Least Squares Mean
822923|NCT01160237|Secondary|Humoral Immune Response in Terms of HI Antibodies Against Each Vaccine Strain, at Different Timepoints in Subjects Aged 18-60 and Above 60 Years||At Days 0, 7 and 182|This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.|||||
822924|NCT01160237|Secondary|Potential Immune Mediated Diseases||During the whole study period (Day 0 - Day 182)|This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.|||||
822925|NCT01160237|Secondary|Number of Subjects Reporting Serious Adverse Events||During the whole study period (Day 0 - Day 182)|The analysis was performed on the total vaccinated cohort. No subjects were enrolled in the Control Group by the time the study was prematurely terminated.||subjects|||Number
822926|NCT01160237|Secondary|Number of Subjects Reporting Unsolicited Adverse Events||During 31 days (Day 0 - Day 30) after vaccination|The analysis was performed on the total vaccinated cohort. No subjects were enrolled in the Control Group by the time the study was prematurely terminated.||subjects|||Number
822927|NCT01160237|Secondary|Solicited Local and General Symptoms||During 7 days (Day 0 - Day 6) after vaccination|This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.|||||
822928|NCT01160237|Primary|Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies for Each Vaccine Strain, in Subjects Aged 18-60 and Above 60 Years||21 days after vaccination|This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.|||||
822934|NCT01165983|Secondary|Absolute Change in Inflammatory Cytokines and Growth Factors, MDC ng/mL||12 Weeks post-randomization|||ng/mL||Inter-Quartile Range|Median
822946|NCT01165983|Primary|Skin Blood Flow Before and After Iontophoresis With Acetylcholine and Sodium Nitroprusside|Laser doppler imaging is used to measure microcirculatory changes pre- and post-iontophoresis of acetylcholine (Ach) and sodium nitroprusside (NaNP).|12 Weeks post-randomization|||percent change over baseline||Inter-Quartile Range|Median
822947|NCT01165983|Primary|Skin Blood Flow Before and After Iontophoresis With Acetylcholine and Sodium Nitroprusside|Laser doppler imaging is used to measure microcirculatory changes pre- and post-iontophoresis of acetylcholine and sodium nitroprusside.|Baseline|||percentage change over baseline||Inter-Quartile Range|Median
822948|NCT01165983|Primary|Nitroglycerine Induced Vasodilation|Using ultrasound, images are taken pre- and post-vasodilation of the brachial artery induced with a 0.4mg tablet of NTG.|12 Weeks post-randomization|||percent change||Inter-Quartile Range|Median
822949|NCT01165983|Primary|Nitroglycerin Induced Dilation|Using ultrasound, images are taken pre- and post-vasodilation of the brachial artery induced with a 0.4mg tablet of NTG.|Baseline|||percent change||Standard Deviation|Mean
822950|NCT01165983|Primary|Flow Mediated Vasodilation|Using ultrasound, percent change in brachial artery diameter is measured in response to an increase in shear stress from a tightened blood pressure cuff, which causes endothelium-dependent dilatation.|12 Weeks post-randomization|Number of subjects that completed the study||percent change over baseline||Inter-Quartile Range|Median
822951|NCT01165983|Primary|Flow Mediated Vasodilation|Using ultrasound, percent change in brachial artery diameter is measured in response to an increase in shear stress from a tightened blood pressure cuff, which causes endothelium-dependent dilatation.|Baseline|||percentage change over baseline||Standard Deviation|Mean
822952|NCT01165996|Secondary|Proportion of Patients With Particular Genetic Abnormalities Detected by Whole Exome Sequencing Correlation With Clinical Response|Proportion of patients with particular genetic abnormalities detected by whole exome sequencing correlation with clinical response|Baseline||03/2013||||
822953|NCT01165996|Secondary|Proportion of Patients With Bone Marrow Evidence of Terminal Differentiation Response to Therapy.|Bone marrow evidence of terminal differentiation will be correlated with response criteria|Day 0,42,84||03/2013||||
822954|NCT01165996|Secondary|Proportion of Patients With Bone Marrow Evidence of Cytotoxicity.|Cytotoxicity will be correlated with clinical response criteria|Day 0, 42, 84||03/2013||||
822955|NCT01165996|Secondary|Proportion of Patients With Pharmacodynamic Evidence of Drug Effect.|Evidence of pharmacodynamic effect will be correlated with clinical response criteria.|Day 0, 42, 84||03/2013||||
822956|NCT01165996|Secondary|Cytogenetic Response as Per IWG Criteria|Described as the number of patients with a major cytogenetic response (refers to disappearance of a cytogenetic abnormality) or a minor cytogenetic response (50% or more reduction of abnormal metaphases).|at 12 months|Patients that had cytogenetic abnormalities at baseline.||participants|||Number
822957|NCT01165996|Secondary|Number of Patients That Experience > Grade 2 Non-hematologic Toxicity by National Cancer Institute (NCI)/Cancer Therapy Evaluation Program (CTEP) v4 Criteria|Incidence of treatment-emergent adverse events (AEs) will be presented in tables that include causality, seriousness, severity/grade, and whether the AE resulted in death or discontinuation of treatment, Laboratory data will be summarized in tables that show changes from pre-treatment values and frequencies of abnormal values. Descriptive statistics will also be provided.|up to 12 months of treatment|All patients that received treatment.||participants|||Number
822958|NCT01165996|Primary|Number of Patients With Response as Defined by IWG (International Working Group) Criteria for Myelodysplasia|The criteria for complete remission (CR) and partial remission (PR) involve specific improvements in marrow and peripheral blood measurements obtained on 2 or more successive assessments. The response parameters in peripheral blood must be maintained for at least 8 weeks. Responses designated as CR include less than 5% marrow blasts without evidence of dysplasia and normalization of peripheral blood counts, including a hemoglobin level of 110 g/L (11 g/dL) or more, a neutrophil count of 1.5 × 109/L or more, and a platelet count of 100 × 109/L or more. For PR, patients must demonstrate all CR criteria if abnormal before treatment except that marrow blasts should decrease by 50% or more compared with pretreatment levels, or patients may demonstrate a less-advanced MDS disease classification category than prior to treatment.|Formal assessment at week 12 for study primary end-point (hematologic improvement).|All patients enrolled and that received any treatment.||participants|||Number
822959|NCT01166139|Secondary|Efficacy of Nilotinib in Patients With Systemic Sclerosis, as Defined by an Improvement in the Modified Rodnan Skin Score|"Improvement in Modified Rodnan skin score reported as a mean (units equals number of points).
The Modified Rodnan Skin Score (MRSS) measures dermal skin thickness through the examination of 17 body areas: fingers, hands, forearms, arms, feet, legs, and thighs (in pairs), and face, chest, and abdomen. In each of these areas, the skin score is evaluated by manual palpation. The skin score is 0 for uninvolved skin, 1 for mild thickening, 2 for moderate thickening, and 3 for severe thickening (hidebound skin). The total skin score is the sum of the skin scores of the individual areas. The minimum score is 0 and the maximum score is 51. A higher score indicates greater severity of disease."|12 months treatment|||units on a scale|||Number
822960|NCT01166139|Secondary|Improvement of Modified Rodnan Skin Score Reported as a Mean (Units Equals Number of Points)|Efficacy of Nilotinib in patients with systemic sclerosis, as defined by an improvement in the Modified Rodnan Skin Score (MRSS) The Modified Rodnan Skin Score (MRSS) measures dermal skin thickness through the examination of 17 body areas: fingers, hands, forearms, arms, feet, legs, and thighs (in pairs), and face, chest, and abdomen. The skin score is evaluated by manual palpation in each of these areas. The skin score is 0 for uninvolved skin, 1 for mild thickening, 2 for moderate thickening, and 3 for severe thickening (hidebound skin). The total skin score is the sum of the skin scores of the individual areas where the minimum score is 0 and the maximum score is 51. A higher score indicates greater severity of disease.|6 Months of treatment|||units on a scale|||Number
822961|NCT01166139|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability||6 Months and 12 months treatment|||Adverse Events|||Number
822962|NCT01166178|Secondary|Adverse Events and Serious Adverse Events Comparison of Treatment Groups|Adverse Events and Serious Adverse events are reported in the safety section.|24 months|A total of 168 randomized participants were needed to have a power of 93% % to detect a significant difference in lumbar spine BMD. This study randomized 29 participants of the planned 168; hence, the planned analysis was not done. The sample size was not powered for comparison between groups; however, all AEs are reported in the safety section.|||||
822963|NCT01166178|Secondary|Course of Disease in Multiple Sclerosis Patients|The course of disease in Multiple Sclerosis (MS) patients was measured comparing results from the Expanded Disability Status Scale (EDSS) from screening and month 12. EDSS is a scale, ranging from 0 (normal) to 10 (death due to MS) for assessing neurologic impairment in MS. It is based on a weighting scheme of eight functional systems. The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel&Bladder, Cerebral and Other functions. EDSS was assessed by the treating neurologist.|Screening (day -21 to -1) and month 12|A total of 168 randomized participants were needed to have a power of 93% % to detect a significant difference in lumbar spine BMD. This study randomized 29 participants of the planned 168; hence, the planned analysis was not done.|||||
822964|NCT01166178|Secondary|Change in Bone Mineral Density of the Femoral Neck at 24 Months|"Change in bone mineral density (BMD) of the femoral neck was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 24.
A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone."|Screening (day -21 to -1) and month 24|A total of 168 randomized participants were needed to have a power of 93% % to detect a significant difference in lumbar spine BMD. This study randomized 29 participants of the planned 168; hence, the planned analysis was not done.|||||
822965|NCT01166178|Secondary|Change in Bone Mineral Density of the Total Hip Region at 24 Months|"Change in bone mineral density (BMD) of the total hip region was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 24.
A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone."|Screening (day -21 to -1) and month 24|A total of 168 randomized participants were needed to have a power of 93% % to detect a significant difference in lumbar spine BMD. This study randomized 29 participants of the planned 168; hence, the planned analysis was not done.|||||
822966|NCT01166178|Primary|Change in Bone Mineral Density of the Total Hip Region at 12 Months|"Change in bone mineral density (BMD) of the total hip region was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 12.
A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone."|Screening (day -21 to -1) and month 12|A total of 168 randomized participants were needed to have a power of 93% % to detect a significant difference in lumbar spine BMD. This study randomized 29 participants of the planned 168; hence, the planned analysis was not done.|||||
822967|NCT01166178|Secondary|Change in Bone Mineral Density of the Lumbar Spine at 24 Months|"Change in bone mineral density (BMD) of the lumbar spine was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 24.
A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone."|Screening (day -21 to -1) and month 24|A total of 168 randomized participants were needed to have a power of 93% % to detect a significant difference in lumbar spine BMD. This study randomized 29 participants of the planned 168; hence, the planned analysis was not done.|||||
822968|NCT01166178|Secondary|Change in Bone Mineral Density of the Femoral Neck at 12 Months|"Change in bone mineral density (BMD) of the femoral neck was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 12.
A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone."|Screening (day -21 to -1) and month 12|A total of 168 randomized participants were needed to have a power of 93% % to detect a significant difference in lumbar spine BMD. This study randomized 29 participants of the planned 168; hence, the planned analysis was not done.|||||
822969|NCT01166178|Secondary|Change in Bone Mineral Density of the Total Hip at 6 Months|Change in bone mineral density (BMD) of the total hip was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 6. A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone.|Screening (day -21 to -1) and month 6|A total of 168 randomized participants were needed to have a power of 93% % to detect a significant difference in lumbar spine BMD. This study randomized 29 participants of the planned 168; hence, the planned analysis was not done.|||||
822970|NCT01166178|Secondary|Change in Bone Mineral Density of the Femoral Neck at 6 Months|"Change in bone mineral density (BMD) of the femoral neck was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 6.
A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone."|Screening (day -21 to -1) and month 6|A total of 168 randomized participants were needed to have a power of 93% % to detect a significant difference in lumbar spine BMD. This study randomized 29 participants of the planned 168; hence, the planned analysis was not done.|||||
822971|NCT01166178|Secondary|Change in Bone Mineral Density of the Lumbar Spine at 6 Months|"Change in bone mineral density (BMD) of the lumbar spine was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 6.
A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone."|Screening (day -21 to -1) and month 6|A total of 168 randomized participants were needed to have a power of 93% % to detect a significant difference in lumbar spine BMD. This study randomized 29 participants of the planned 168; hence, the planned analysis was not done.|||||
822972|NCT01166178|Primary|Change in Bone Mineral Density of the Lumbar Spine at 12 Months|"Change in bone mineral density (BMD) of the lumbar spine was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 12.
A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone."|Screening (day -21 to -1) and month 12|A total of 168 randomized participants were needed to have a power of 93% % to detect a significant difference in lumbar spine BMD. This study randomized 29 participants of the planned 168; hence, the planned analysis was not done.|||||
822973|NCT01166230|Secondary|Rate of Progression|"Only patients with Ta/T1 were included in the follow-up study. Progression is defined as presence of T2-T4 tumors, with or without carcinoma in situ (CIS), at worst recurrence."|4.5 years|||percentage of patients|||Number
822974|NCT01166230|Primary|Recurrence Free Survival||up to 4.5 years|Intention-to-treat (ITT)||months||95% Confidence Interval|Median
822975|NCT01166230|Other Pre-specified|Median Time to Recurrence||up to 4.5 years|ITT||months||95% Confidence Interval|Median
822976|NCT01166230|Other Pre-specified|Longer-term Recurrence-free Rates After Hexvix (Cysview) and Non-Hexvix (Cysview) Cystoscopy/TURB|To extend the follow-up period of the pivotal trial (B305/04) to up in all available patients, to assess a longer-term estimate of recurrence-free rates after Hexvix and non-Hexvix cystoscopy/TURB, and to assess numbers and types of recurrences, amount and type of treatment given, and numbers of deaths.|up to 5.5 years retrospectively|ITT||percentage of paticipants|||Number
824921|NCT01178671|Secondary|Depression Severity|as measured by the 17-item Hamilton Rating Scale for Depression, which rates severity of depression on a scale from 0 (least depression) to 50 (greatest depression).|up to 24 weeks|intent to treat||units on a scale||Standard Deviation|Mean
822977|NCT01166282|Secondary|Number of Participants With Adverse Events (AEs)|"An AE is any untoward medical occurrence in a participant which does not necessarily have a causal relationship with this treatment. A serious AE (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs or TESAE) are defined as any event that began or worsened in severity after the first dose of study drug. The investigator assessed the relationship of each event to the use of study drug as either probably related to study drug, possibly related to study drug, probably not related, or not related to study drug.
For more details on adverse events please see the AE section below."|Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks)|Safety population: All randomized subjects who received at least 1 dose of study drug||participants|||Number
822978|NCT01166282|Secondary|Percentage of Participants Achieving Pediatric American College of Rheumatology Pediatric 70% Response (ACR Pedi70)|The ACR Pedi70 response is defined as ≥70% improvement in at least 3 of 6 JRA core set criteria with no more than 1 of the 6 criteria with >30% worsening. The 6 variables for the JRA core set criteria are Physician's Global Assessment (PGA) of participant's disease activity, Parent's Global Assessment of participant's overall well-being, number of active joints (joints with swelling not due to deformity or joints LOM plus pain and/or tenderness), number of joints with LOM, Childhood Health Assessment Questionnaire (CHAQ), and high sensitivity C-reactive protein (hs CRP). Baseline is the last value prior to the first dose of study drug. Non-responder imputation NRI was used.|Baseline and Week 12|ITT population||percentage of participants|||Number
822979|NCT01166282|Secondary|Percentage of Participants Achieving Pediatric American College of Rheumatology Pediatric 50% Response (ACR Pedi50)|The ACR Pedi50 response is defined as ≥50% improvement in at least 3 of 6 JRA core set criteria with no more than 1 of the 6 criteria with >30% worsening. The 6 variables for the JRA core set criteria are Physician's Global Assessment (PGA) of participant's disease activity, Parent's Global Assessment of participant's overall well-being, number of active joints (joints with swelling not due to deformity or joints LOM plus pain and/or tenderness), number of joints with LOM, Childhood Health Assessment Questionnaire (CHAQ), and high sensitivity C-reactive protein (hs CRP). Baseline is the last value prior to the first dose of study drug. NRI was used.|Baseline and Week 12|ITT population||percentage of participants|||Number
822980|NCT01166282|Secondary|Percentage of Participants Achieving Pediatric American College of Rheumatology Pediatric 30% Response (ACR Pedi30)|The ACR Pedi30 response is defined as ≥30% improvement in at least 3 of 6 juvenile rheumatoid arthritis (JRA) core set criteria with no more than 1 of the 6 criteria with >30% worsening. The 6 variables for the JRA core set criteria are Physician's Global Assessment (PGA) of participant's disease activity, Parent's Global Assessment of participant's overall well-being, number of active joints (joints with swelling not due to deformity or joints LOM plus pain and/or tenderness), number of joints with LOM, Childhood Health Assessment Questionnaire (CHAQ), and high sensitivity C-reactive protein (hs CRP). Baseline is the last value prior to the first dose of study drug. Non-responder imputation (NRI) was used for missing data.|Baseline and Week 12|ITT population||percentage of participants|||Number
822981|NCT01166282|Secondary|Swollen Joint Count (SJC68): Change From Baseline to Week 12|Sixty-eight joints were assessed by physical examination. Joint swelling was classified as present or absent. Scores range from 0 to 68, with higher scores representing higher disease activity. Baseline is defined as the last nonmissing value prior to the first dose of study drug. LOCF was used.|Baseline and Week 12|ITT population||units on a scale||Standard Deviation|Mean
822982|NCT01166282|Secondary|Tender Joint Count (TJC72): Change From Baseline to Week 12|Seventy-two joints were assessed by pressure on physical examination. Joint tenderness was classified as either present or absent. Scores range from 0 to 72, with higher scores representing higher disease activity. Baseline is defined as the last nonmissing value prior to the first dose of study drug. LOCF was used.|Baseline and Week 12|ITT population||units on a scale||Standard Deviation|Mean
822983|NCT01166282|Secondary|Number of Sites of Enthesitis: Change From Baseline to Week 12|The presence of enthesitis was assessed by pressure at 35 anatomical locations. Enthesitis was classifed as either present or absent. Scores range from 0 to 35, with higher scores representing higher disease activity. Baseline is defined as the last nonmissing value prior to the first dose of study drug. LOCF was used.|Baseline and Week 12|ITT population||sites of enthesitis||Standard Deviation|Mean
822984|NCT01166282|Primary|Percent Change in Number of Active Joints With Arthritis From Baseline to Week 12|A joint assessment was recorded at all study visits to assess the number of active joints. A total of 72 joints were assessed for swelling not due to deformity or joints with loss of motion (LOM) plus pain and/or tenderness. Total possible scores ranges from 0 (no active joints) to 72 (all active joints). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Last Observation Carried Forward (LOCF) was used for missing data.|Baseline and Week 12|ITT population||percent change||Standard Deviation|Mean
822985|NCT01166646|Secondary|"Number of Subjects Whose Signs of Psoriasis Was Designated Success"|Signs of psoriasis including scaling, erythema, and plaque elevation will be recorded at baseline, Day 8, and Day 15 on a 0 (clear) to 4 (severe/very severe) point scale. Each of the signs of psoriasis will be dichotomized to a) “success” and “failure” with success defined as a grade of 1 or 0 at the End of Treatment (EOT; i.e., the visit at which psoriasis has cleared [Day 8 or Day 15] or end of the assigned treatment period).|Day 15|"Analysis shown is based on the number of subjects whose Signs of Psoriasis was designated Success (ITT population) at Day 15."||participants|||Number
822986|NCT01166646|Secondary|Changes in Disease Severity (Success)|Overall disease severity (ODS) will be recorded at baseline, Day 8, and Day 15 on a 0 (clear) to 4 (severe/very severe) point scale. ODS evaluations will be dichotomized to “success” and “failure” with success defined as a grade of 1 or 0 at the end of treatment (EOT).|Day 15|Analysis shown is based on the ITT population at Day 15.||participants|||Number
822987|NCT01166646|Primary|Pharmacokinetic Properties (AUC)|Comparison of PK results (area under the curve [AUC] from time 0 to infinity) between the two Treatment Groups will be conducted following the last application of the medication on Day 8.|Day 8|Pharmacokinetics properties were evaluated in a subgroup of 12 adult subjects per arm.||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
822988|NCT01166646|Primary|Pharmacokinetic Properties (Tmax)|Comparison of PK results (time to peak concentration [Tmax]) between the two Treatment Groups will be conducted following the last application of the medication on Day 8.|Day 8|Pharmacokinetic properties were evaluated in a subgroup of 12 adult subjects per arm.||Hours||Full Range|Geometric Mean
822989|NCT01166646|Primary|Pharmacokinetic Properties (Cmax)|Comparison of PK results (peak concentration in plasma [Cmax]) between the two Treatment Groups will be conducted following the last application of the medication on Day 8.|Day 8|Pharmacokinetic properties were evaluated in a subgroup of 12 adult subjects per arm.||pg/mL||Geometric Coefficient of Variation|Geometric Mean
822990|NCT01166646|Primary|Adrenal Suppression Potential|Hypothalamic Pituitary-Adrenal (HPA)-Axis responses to Cosyntropin Stimulation Testing (CST) were dichotomized to normal and abnormal. An abnormal HPA Axis response (HPA Suppression) was defined as a 30-minute post-stimulation serum cortisol level of ≤18 μg/dL at the end of treatment.|After 1-2 weeks dose|Analysis shown is based on the ITT population, defined as all enrolled participants who were randomized and applied at least one dose of the test article.||participants|||Number
822991|NCT01166659|Secondary|Mean Number of Topical IOP-Lowering Medications Used in Comparison With Baseline|The number of unique glaucoma medications was recorded. The mean number of topical IOP-lowering medications was computed by dividing the total number of medications used (the numerator) by the total number of subjects who reported on medication use at the visit.|Baseline, Month 12 postoperative|Eyes implanted with the CyPass 2FX device with data available.||medications|eyes|Standard Deviation|Mean
822992|NCT01166659|Secondary|Proportion of Eyes With Achievement of Target IOP With and Without Use of Ocular Hypotensive Medication|Target IOP was defined as ≥ 6 mmHg and ≤ 21 mmHg. Proportion of eyes is reported as a percentage.|Month 12 postoperative|Eyes implanted with the CyPass 2FX device with data available.||percentage of eyes|eyes||Number
822993|NCT01166659|Primary|Proportion of Eyes With Intraocular Pressure (IOP) Reduction of ≥ 20% at 12 Months Postoperatively Who Were on Fewer or the Same Number of Ocular Hypotensive Medications as Compared With Baseline|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). A reduction in IOP from baseline indicates an improvement. Proportion of eyes is reported as a percentage.|Baseline; Month 12 postoperative|Eyes implanted with the CyPass 2FX device with data available.||percentage of eyes|eyes||Number
822994|NCT01166724|Secondary|Change in iGFR|We will also compare the change in iGFR (as well as estimated GFR) from time of conversion to 12 and 24 months of follow up by paired t-test between groups.|12 months|Early termination; Sponsor discontinued the study for corporate reasons. No data analyzed. Data were not collected and the outcome measure was not analyzed.|||||
822995|NCT01166724|Primary|Biopsy-derived Measures of Fibrosis|The primary analyses will compare biopsy-derived measures of fibrosis in the Tac-maintenance and SRL groups using the t-test.|12 months|Early termination; Sponsor discontinued the study for corporate reasons. No data analyzed. Data were not collected and the outcome measure was not analyzed.|||||
822996|NCT01166750|Secondary|Quality of Life||weekly for 12 weeks||||||
822997|NCT01166750|Secondary|Mood and Stress||weekly for 12 weeks||||||
822998|NCT01166750|Primary|Pain|Pain intensity on a 0 to 10 visual analog scale with 0 being no pain and 10 being worst possible pain.|weekly for 12 weeks|They were the ones still remaining at the end of the study.||units on a scale||Standard Deviation|Mean
822999|NCT01166763|Secondary|OH Vitamin D Levels in Serum|Assessment of 25(OH)D levels as a measure of circulating vitamin D.|baseline and 6 months|All subjects completing trial||ng/ml||Standard Deviation|Mean
823000|NCT01166763|Secondary|Change in Proliferation (as Assessed by Ki-67) Examined in Breast Epithelial Cells.|Change in percent of cells expressing staining for Ki-67 antibody in breast epithelial cell specimens acquird by Random Periareolar Fine Needle Aspiration.|baseline and 6 months|All subjects completing trial.||percentage of cells staining positive||Full Range|Median
823001|NCT01166763|Primary|Change in Mammographic Breast Density Over Course of Study|Change in the percent of the breast area that is considered to be at higher density on mammogram.|baseline and 6 months|All subjects completing trial||Change in percent dense breast area||Standard Deviation|Mean
823002|NCT01166958|Secondary|Average Bone Mineral Density of the One-third Radius at Baseline, 3 Months and 6 Months|One-third radius BMD was measured at the baseline, three month and six month visits. The outcome data is an overall average and range from all time points.|BMD measured at the baseline, 3 month, and 6 month visits.|||g/cm2||Full Range|Mean
823003|NCT01166958|Secondary|Average Bone Mineral Density of the Proximal Femur (Hip) at Baseline, 3 Months and 6 Months|Hip BMD was measured at the baseline, three month and six month visits. The outcome data is an overall average and range from all time points.|BMD measured at the baseline, 3 month, and 6 month visits.|||g/cm2||Full Range|Mean
823004|NCT01166958|Primary|Serum Markers of Skeletal Turnover (Serum P1NP)|Serum P1NP was measured at all study visits following the screening visit. The outcome data is an overall average and range from all time points.|These were measured at the baseline and 1, 1.5, 2, 2.5, 3, 4, 5 and 6 month visits.|||mcg/L||Full Range|Mean
823005|NCT01166958|Secondary|Average Bone Mineral Density of the Spine at Baseline, 3 Months and 6 Months|Spine BMD was measured at the baseline, three month and six month visits. The outcome data is an overall average and range from all time points.|BMD measured at the baseline, 3 month, and 6 month visits.|||g/cm2||Full Range|Mean
823006|NCT01166958|Primary|Serum Markers of Skeletal Turnover (Serum CTX)|Serum CTX was measured at all study visits following the screening visit. The outcome data is an overall average and range from all time points.|These were measured at the baseline and 1, 1.5, 2, 2.5, 3, 4, 5 and 6 month visits.|||ng/mL||Full Range|Mean
823007|NCT01166971|Primary|Defocus Curve|A defocus curve is created by multiple measurements of one's visual acuity at different spherical powers (recorded as Diopters (D)). Visual Acuity (VA) is measured in logMAR. LogMAR is the “logarithm of the minimum angle of resolution”.|3 months after surgery|In the ReSTOR +3 population, 1 subject did not complete the assessment at -5.00 D; therefore, only 32 subjects were used for this measure.||LogMAR||Standard Deviation|Mean
823008|NCT01166997|Primary|Major Bleeding and Intracranial Bleeding at 30 Days.|Bleeding will be classified as major if it is associated with a fall in the hemoglobin level of at least 2.0 g/dl, transfusion of ≥ 2 units of red blood cells, or involvement of a critical site (e.g., intracranial, intraspinal). To aid in evaluating the relationship of bleeding events to rt-PA administration, they will also be categorized by whether they occurred within 3 days after the initiation of thrombolytic therapy.|30 days|||participants|||Number
823010|NCT01167023|Secondary|P2Y12 Reaction Units (PRU) as Measured by Accumetrics VerifyNow® P2Y12 (VN P2Y12) at 30 Days|PRU represents the rate and extent of adenosine (ADP)-stimulated platelet aggregation. The VN P2Y12 assay is a point-of-care device that measures platelet aggregation with single-use, disposable cartridges. A low PRU reflects stronger inhibition of P2Y12, whereas a high PRU reflects weaker inhibition of P2Y12. The Least Squares Mean values were calculated from a mixed-effects model repeated measures analysis with baseline measurement, stratification variable sickle cell genotype, treatment, time, and time*treatment interaction as fixed effects, and participant as a random effect in the model.|30 days|Safety population: All randomized participants who took at least 1 dose of study medication. Participants were analyzed according to the treatment they actually received. The analysis was performed in the safety population who had both baseline and 30-day PRU measurements and a non-missing genotype.||P2Y12 Reaction Units (PRU)||Standard Error|Least Squares Mean
823011|NCT01167023|Secondary|Intensity of Pain Related to Sickle Cell Disease (SCD) During the Treatment Duration|Participants recorded intensity of pain due to SCD each day in daily pain diaries using a pain scale. A scale of 0 to 9 was used, with 0=no pain and 9=unbearable pain. A response range of 1 to 9 indicated participant experienced pain due to SCD, whereas a response of 0 indicated participant did not experience pain due to SCD. Pain intensity was the average of a participant's pain ratings. Average pain intensity=(Sum of all nonmissing pain intensity responses/number of daily pain diaries completed). Number of daily pain diaries completed is number of nonmissing pain intensity responses.|Baseline through 30 days|Intent to treat (ITT) population consisted of all randomized participants. Participants were analyzed according to the treatment they were randomized to. The analysis was performed in the ITT population who had recorded the pain intensity in at least 1 daily pain diary.||units on a scale||Standard Deviation|Mean
823012|NCT01167023|Secondary|Platelet Reactivity Index (PRI) Measured by Vasodilator-Associated Stimulated Phosphoprotein (VASP) at 30 Days|PRI was calculated by VASP phosphorylation assay using flow cytometry. The PRI indicates the level of P2Y12 inhibition. A low PRI reflects strong inhibition of P2Y12, whereas a high PRI reflects weak/absent inhibition of P2Y12. The Least Squares (LS) Mean values were calculated from a mixed-effects model repeated measures (MMRM) analysis with baseline measurement, stratification variable sickle cell genotype, treatment, time, and time*treatment interaction as fixed effects, and participant as a random effect in the model.|30 days|All randomized participants who took at least 1 dose of study medication. Participants were analyzed according to the treatment they actually received. The analysis was performed in the safety population who had both baseline and 30-day PRI measurements and a non-missing genotype.||percentage of PRI||Standard Error|Least Squares Mean
823013|NCT01167023|Secondary|Percentage of Participants With Pain Events Related to Sickle Cell Disease (SCD) Requiring Medical Attention During the Treatment Duration|Pain requiring medical attention was defined 2 ways: (1) if the participant attended an unplanned doctor’s appointment or clinic visit, visited the emergency room, or was admitted to hospital due to sickle cell pain, or (2) if the participant experienced a vaso-occlusive crisis (VOC), acute chest syndrome, or hepatic sequestration at least once during the treatment period.|Baseline through 30 days|Intent to treat (ITT) population consisted of all randomized participants. Participants were analyzed according to the treatment they were randomized to. The analysis was performed in the ITT population who completed at least 1 page of the daily pain diary or with pain endpoint case report form (CRF) data available.||percentage of participants|||Number
823014|NCT01167023|Secondary|Percentage of Days With Pain Related to Sickle Cell Disease (SCD) During the Treatment Duration|Participants recorded the intensity of pain due to SCD each day in the daily pain diaries. A scale of 0 to 9 was used, with 0 indicating no pain, and 9 indicating unbearable pain. A response range of 1 to 9 indicated the participant experienced pain due to SCD, whereas a response of 0 indicated participant did not experience pain due to SCD. The percentage of days with pain (pain rate) was calculated as follows: Pain rate = 100*(Total number of days with pain/number of daily pain diaries completed). Number of daily pain diaries completed was number of nonmissing pain intensity responses.|Baseline through 30 days|Intent to treat (ITT) population consisted of all randomized participants. Participants were analyzed according to the treatment they were randomized to. The analysis was performed in the ITT population who recorded pain intensity in at least 1 daily pain diary.||percentage of days||Standard Deviation|Mean
823015|NCT01167023|Secondary|Percentage of Participants With Hemorrhagic Treatment-Emergent Adverse Events (TEAEs) During the Treatment Duration|TEAEs were defined as AEs that occurred or worsened after receiving the study drug.|Baseline through 30 days|Safety population: All randomized participants who took at least 1 dose of study medication. Participants were analyzed according to the treatment they actually received.||percentage of participants|||Number
823016|NCT01167023|Primary|Percentage of Participants With Hemorrhagic Events Requiring Medical Intervention During the Treatment Duration|A hemorrhagic event requiring medical intervention. Medical intervention was defined as any medical attention resulting in therapy or further investigation during the 30-day treatment duration.|Baseline through 30 days|Safety population: All randomized participants who took at least 1 dose of study medication. Participants were analyzed according to the treatment they actually received.||percentage of participants|||Number
823017|NCT01167140|Secondary|Participants With an Improvement in Global Appearance|• Subjects’ global assessment of change in appearance of target area at 7 days post-treatment, and at 30-day intervals for 120 days after treatment to baseline|Up to 4 months|5 subjects were excluded from effectiveness analysis because they received a lower dose.||participants|||Number
823018|NCT01167140|Secondary|Participants With One Point Improvement in Line Severity|• Investigators’ rating of line severity improvement in the target area in animation at 7 days post-treatment, and at 30-day intervals for 120 days after treatment from baseline|Baseline and up to 4 months|Of the 41 subjects treated, 5 were treated at a lower dose and excluded from the effectiveness measure.||participants|||Number
823019|NCT01167140|Primary|Number of Participants With Effectiveness and Safety Success|"Effectiveness success: an improvement in line severity in the target area in animation at 30 days post-treatment as rated by the investigator using the 5-point wrinkle scale
Safety success: the absence of a device-related serious adverse event (DSAE)"|Up to 4 months|All subjects treated were analyzed to the safety endpoint.||participants|||Number
823266|NCT01170546|Primary|Static Knee Stability|The KT-2000 knee ligament arthrometer (MED Metric Co., San Diego, USA) is designed to assess the anterior drawer laxity of the knee joint. The discrepancy of anterior displacement between the sound side and the lesion side is applied in evaluating the static stability of the knee.|one year||12/2010||||
823020|NCT01167153|Secondary|Change From Baseline in Orthostatic Pulse at 12 Weeks|Orthostatic pulse was measured by sphygmomanometer when subject stood for 1 minute at clinic during each visit.|Baseline, 12 weeks|ITT (intention to treatment) population: all randomised subjects who had baseline assessment and at least one assessment record of orthostatic pulse rate after baseline.||beats/min||Standard Deviation|Mean
823021|NCT01167153|Secondary|Change From Baseline in Sitting Pulse at 12 Weeks|Sitting pulse was measured by sphygmomanometer after subject sat for 5 minutes at clinic during each visit.|Baseline, 12 weeks|ITT (intention to treatment) population: all randomised subjects who had baseline assessment and at least one assessment record of sitting pulse rate after baseline.||beats/min||Standard Deviation|Mean
823022|NCT01167153|Secondary|Change From Baseline in Orthostatic SBP and DBP at 12 Weeks|The arm with higher sitting blood pressure was selected for all examinations throughout the study. Orthostatic blood pressure was measured when subject stood for 1 minute. Orthostatic blood pressures were measured at screening and each visit.|Baseline, 12 weeks|ITT (intention to treatment) population: all randomised subjects who had baseline assessment and at least one assessment record of orthostatic SBP and DBP after baseline.||mm Hg||Standard Deviation|Mean
823023|NCT01167153|Secondary|Percentage of Patients in Whom Blood Pressure Target Was Achieved at the Study End Point at 12 Weeks|Blood Pressure (BP) target was defined as mean sitting BP<140/90 mm Hg in non-diabetic patients and<130/80 mm Hg in diabetic patients at 12 weeks.|12 weeks|ITT (intention to treatment) population: all randomised subjects who had baseline assessment and at least one assessment record of blood pressure control after baseline||Percentage of participants|||Number
823024|NCT01167153|Secondary|Percentage of Patients With Effective Systolic Blood Pressure (SBP) Control Rate and Effective Diastolic Blood Pressure (DBP) Control Rate at the Study End Point (12 Weeks)|"Effective SBP control rate was defined as proportion of subjects in whom MSSBP < 140 mmHg or MSSBP reduction ≥ 20 mmHg from baseline.
Effective DBP control rate was defined as proportion of subjects in whom MSDBP < 90 mmHg or MSDBP reduction ≥10 mmHg from baseline."|Baseline, 12 weeks|ITT (intention to treatment) population: all randomised subjects who had baseline assessment and at least one assessment record of effective BP control after baseline.||Percentage of participants|||Number
823025|NCT01167153|Primary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at the Study End Point (12 Weeks)|The sitting blood pressure was trough value (23-26 hours after drug administration) measured by sphygmomanometer. Blood pressure was measured on both arms and the arm with higher msDBP was used at visit 1 and following visits. Measurement of blood pressure was carried out 3 times at each visit on the selected arm. The results and mean value of three sitting blood pressures were recorded for analysis.|Baseline, 12 weeks|ITT (intention to treatment) population: all randomised subjects who had baseline assessment and at least one assessment record of MSDBP after baseline.||mm Hg||Standard Deviation|Mean
823026|NCT01167153|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at the Study End Point (12 Weeks)|The sitting blood pressure was trough value (23-26 hours after drug administration) measured by sphygmomanometer. Blood pressure was measured on both arms and the arm with higher mean sitting diastolic blood pressure (MSDBP) was used at visit 1 and following visits. Measurement of blood pressure was carried out 3 times at each visit on the selected arm. The results and mean value of three sitting blood pressures were recorded for analysis.|Baseline, 12 weeks|ITT (intention to treatment) population: all randomised subjects who had baseline assessment and at least one assessment record of MSSBP after baseline.||mm Hg||Standard Deviation|Mean
823027|NCT01167192|Secondary|Determine the Effect of Neoadjuvant Chemoradiation Therapy in Disseminated Cancer Cells in the Bone Marrow and the Correlation to Tumor Response||Up to 15 months from time of registration|The physician who was to perform the correlative laboratory work for the study left the university prior to performing the correlative work for this study.|||||
823028|NCT01167192|Secondary|Successful Development of Animal Models of Triple Negative Breast Cancer as Measured by the Genetic Similarity Between the Primary Tumor and the Tumor in Animals||At the time of IVAD placement and at the time of surgery|Participants did not have sufficient tissue for this outcome measure to be analyzed.|||||
823029|NCT01167192|Secondary|Successful Development of Animal Models in Triple Negative Breast Cancers as Measured by the Ability of the Tumors to Metastasize to Other Organs||At the time of IVAD placement and at the time of surgery|Participants did not have sufficient tissue for this outcome measure to be analyzed.|||||
823030|NCT01167192|Secondary|Successful Development of Animal Models for Triple Negative Breast Cancers as Measured by the Ability to Passage the Tumors in Mice||At the time of IVAD placement and at the time of surgery|Participants did not have sufficient tissue for this outcome measure to be analyzed.|||||
823031|NCT01167192|Secondary|Successful Development of Animal Models of Triple Negative Breast Cancers as Measured by the Ability to Grow the Tumors in Mice.||At the time of IVAD placement and at the time of surgery|Participants did not have sufficient tissue for this outcome measure to be analyzed.|||||
823032|NCT01167192|Secondary|Medical Toxicities as Measured by Number of Grade 3 or Higher Adverse Events||30 days post surgery (approximately 16-20 weeks after start of registration)|||adverse event|||Number
823033|NCT01167192|Secondary|Overall Survival Rate||Median follow-up was 59.9 months|1 patient was removed from study due to treatment related toxicity prior to surgery and 1 patient expired prior to surgery. These 2 patients are not included in this outcome measure.||percentage of participants|||Number
823034|NCT01167192|Secondary|Determine the Effect of Neoadjuvant Chemoradiation Therapy in Disseminated Cancer Cells in the Bone Marrow||Up to 15 months from registration|The physician who was to perform the correlative laboratory work for the study left the university prior to performing the correlative work for this study.|||||
823035|NCT01167192|Secondary|Number of Participants With Surgical Complications||30 days post surgery (approximately 16-20 weeks from registration)|1 patient was removed from study due to treatment related toxicity prior to surgery and 1 patient expired prior to surgery. These two patients are not included in this outcome measure.||participant|||Number
823092|NCT01167881|Primary|The Change From Baseline in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment.||Baseline and 104 weeks|FAS (LOCF) – Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF); Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.||percentage of HbA1c||Standard Error|Mean
823036|NCT01167192|Secondary|Time to Disease Progression|Progression = at least a 20% increase in the sum of the longest diameter of the target lesions taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions, appearance of one or more new lesions, unequivocal progression of existing non-target lesions.|Up to 5 years from registration|There are 8 participants not included in this outcome measure and the reasons are as follows: (1) removed from study due to treatment related toxicity prior to surgery, (1) expired prior to surgery, and (6) did not have progressive disease.||months||Full Range|Median
823037|NCT01167192|Primary|Relationship Between Tumor Response and Deficiencies in DNA Repair Mechanisms||Prior to surgery (approximately 12-16 weeks from registration)|The physician who was to perform the correlative laboratory work for the study left the university prior to performing the correlative work for this study.|||||
823038|NCT01167192|Primary|Response Rate as Measured by Number of Participants Who Achieved Complete Response (CR) or Partial Response (PR)|"Complete response (CR) = disappearance of all target lesions, disappearance of all non-target lesions and normalization of tumor marker level.
Partial response (PR) = at least a 30% decrease in the sum of the longest diameter (LD) of the target lesions taking as reference the baseline sum LD"|Prior to surgery (approximately 12-16 weeks from registration)|1 patient was removed from study due to treatment related toxicity prior to efficacy evaluation and 1 patient expired prior to efficacy evaluation. These two patients are not included in this outcome measure.||Participants|||Count of Participants
823039|NCT01167257|Secondary|Net Change of the Global Response Assessment (GRA)|Efficacy:(measured the net change of variables from baseline and 1 month) The Global response assessment (GRA) have seven point scale is centered at zero (no change): markedly worse; moderately worse; slightly worse; no change; slightly improved; moderately improved; and markedly improved.|Baseline to 4 weeks after initial treatment|||participants|||Number
823040|NCT01167257|Secondary|Net Change of the Urgency Severity Score (USS) Within 3 Days|Efficacy:(measured the net change of variables from baseline and 1 month) Urgency severity score (USS) within 3 days. The USS have 1-point scale ranging from 0 to 4. The USS grades urgency per toilet void as none, mild, moderate or severe.|Baseline to 4 weeks after initial treatment|||participants|||Number
823041|NCT01167257|Secondary|Net Change of the Postvoid Residual Volume (PVR)|Efficacy:(measured the net change of variables from baseline and 1 month) Postvoid residual volume (PVR) Change = Week 4 minus Baseline value|Baseline and 1 month after initial treatment|||mL||Inter-Quartile Range|Median
823042|NCT01167257|Secondary|Net Change of the Maximum Flow Rate (Qmax)|Efficacy:(measured the net change of variables from baseline and 1 month) Maximum flow rate (Qmax) Change = Week 4 minus Baseline value|Baseline to 4 weeks after initial treatment|Control arm: subject number S025 was removed from analysis for not meeting the requirement for analysis, thus control arm 27 subjects||mL/s||Inter-Quartile Range|Median
823043|NCT01167257|Secondary|Net Change of the Functional Bladder Capacity (FBC)|Efficacy:(measured the net change of variables from baseline and 1 month) Functional bladder capacity (FBC) Change = Week 4 minus Baseline value|Baseline to 4 weeks after initial treatment|Control arm: subject number S025 was removed from analysis for not meeting the requirement for analysis, thus control arm 27 subjects||mL||Inter-Quartile Range|Median
823044|NCT01167257|Secondary|Net Change of the Overactive Bladder Symptom Score (OABSS)|"Efficacy:(measured the net change of variables from baseline to 1 month) Overactive bladder symptom score (OABSS) The OABSS is a 4-item questionnaire developed to evaluate OAB symptoms. The maximal scores are 2, 3, 5 and 5 for daytime frequency, nighttime frequency, urgency and urgency in continence, respectively.
The OABSS range = 0 to 15 ((asymptomatic to very symptomatic). Change = Week 4 minus Baseline value"|Baseline to 4 weeks after initial treatment|||units on a scale||Inter-Quartile Range|Median
823045|NCT01167257|Secondary|Mean Change of the Urgency Urinary Incontinence (UUI) Per 3 Days|"Efficacy:
Mean change of the urgency urinary incontinence (UUI) per 3 days from baseline to 4 weeks after the treatment day based on the 3-day voiding diary.
Change = Week 4 minus Baseline value"|Baseline to 4 weeks after initial treatment|Control arm: subject number S025 was removed from analysis for not meeting the requirement for analysis, thus control arm 27 subjects||Frequency per 3 days||95% Confidence Interval|Median
823046|NCT01167257|Secondary|Mean Change of the Urgency Episodes Per 3 Days|"Efficacy:
Mean change of the Urgency episodes per 3 days from baseline to 4 weeks after the treatment day based on the 3-day voiding diary.
Change = Week 4 minus Baseline value"|Baseline to 4 weeks after initial treatment|Control arm: subject number S025 was removed from analysis for not meeting the requirement for analysis, thus control arm 27 subjects||Frequency per 3 days||95% Confidence Interval|Median
823047|NCT01167257|Primary|Mean Change of the Total Frequency Per 3 Days|"Efficacy:
Mean change of the total frequency per 3 days from baseline to 4 weeks after the treatment day based on the 3-day voiding diary.
Change = Week 4 minus Baseline value"|Baseline to 4 weeks after initial treatment|Control arm: subject number S025 was removed from analysis for not meeting the requirement for analysis, thus control arm 27 subjects||Frequency per 3 days||95% Confidence Interval|Mean
823048|NCT01167426|Secondary|Patient Injection Experience Preference|"The Injection Experience Preference Questionnaire utilizes a 5-level preference scale where participants were asked to compare their injection experience during the first 2 weeks (glatiramer acetate 20 mg/1 mL) with the past 2 weeks (glatiramer acetate 20 mg/0.5 mL). Response options were: 1. strongly prefer first experience (first 2 weeks); 2. somewhat prefer first experience (first 2 weeks); 3. no preference; 4. somewhat prefer second experience (past 2 weeks); 5. strongly prefer second experience (past 2 weeks). Responses 1 and 2 were combined into a single category (prefers first experience) and responses 4 and 5 were combined into a single category (prefers second experience)."|Week 4|Analysis Population with available data.||participants|||Number
823068|NCT01167608|Primary|"2nd Most Commonly Reported Future Barrier to Mental Health Services: Doctors Are Not Sensitive Enough to PD-related Issues"|"The purpose of this study was to assess the 3 most commonly reported past and future barriers to mental health services. This outcome represents the 2nd most commonly reported future barrier to mental health services reported by those who responded to the survey described in the Methods section. Outcome is reported as the percentage of all respondents surveyed who endorsed this particular future barrier. This barrier can best be described as limited knowledge of PD amongst treatment providers.
NOTE: This is an anonymous, cross-sectional survey study. Not all participants responded to every item, so sample size varies between outcome measures."|Lifetime|||percentage of total respondents|||Number
823049|NCT01167426|Primary|Change From Week 2 to Week 6 in Composite Score of Patient Satisfaction With Injection Experience|"The Satisfaction with Injection Experience questionnaire consists of 5 questions where participants are asked to rate their injection experience over the past 2 weeks on ease of use, bother, acceptability, confidence to inject and satisfaction. The response options range from strongly disagree (score = 1) to strongly agree (score = 5). The composite score of Satisfaction with Injection Experience is defined as the mean of the five Likert questions. The composite score ranges from 1.0 to 5.0, with a score of 5.0 representing the most satisfaction with injection experience and a score of 1.0 representing the least satisfaction with injection experience."|Week 2 (prior to first injection with 20 mg/0.5 mL formulation), Week 6 (after 4 weeks of treatment with 20 mg/0.5 mL formulation).|The Analysis Population consisted of of all patients who received at least one dose of study medication and had satisfaction data at time points 2 and 6 weeks, 2 and 4 weeks, or 2, 4 and 6 weeks.||units on a scale||Standard Deviation|Mean
823051|NCT01167504|Secondary|Defined Behaviour of Salivary Film Formation|"A secondary output is a well defined description of the film formation behaviour of normalsaliva in terms of thickness (nm), viscoelastic modulus (mN/m) and temporal behaviour. This will be used to develop model or artificial salivas saliva that forms films in the same way as real saliva ex vivo, that can be used to screen the effects of different compounds and ingredients, without having to collect fresh saliva from human volunteers. The measure is the rate of increase in film thickness (depth, nm) as a function of time, measured by adsorbing whole mouth saliva onto a solid silica surface and measuring the film thickness using Dual Polarisation Interferometry and Quartz Crystal Microbalance."|Within 4 hours of saliva collection.|Literature data and power calculations were used to calculate the number of individuals required to show a statistical significant effect of the presence of ingredients on the thickness of the salivary film.||nm/cm2/min||Standard Deviation|Mean
823052|NCT01167504|Primary|Impact of Ingredients on Thickness (Depth, nm) of Salivary Films Adsorbed Onto Solid Surfaces|The principal output is to determine how ingredients in food and oral hygiene products affect the way that saliva forms films on surfaces similar to those found inside the mouth. We will determine the main physical properties of the film such as thickness (nm), adsorbed mass (ng/cm^2), density (ng/cm^3) measured by adsorbing whole mouth saliva onto solid silica surfaces and measuring the above properties of the film using Dual Polarisation Interferometry and a Quartz Crystal Microbalance. The effect of ingredients from food and oral hygiene products on the above measured parameters will be determined.|Within 4 hours of saliva collection.|Based on published results of saliva pellicle thickness, power calculations showed that 12 individuals would provide sufficient statistical significance to determine the effect of added ingredients on salivary film thickness.||nm||Standard Deviation|Mean
823053|NCT01167582|Primary|Red Blood Cell Transfusion|Differences in mean number of units of red blood cell transfusions between the two study arms.|In-hospital up to 30 days post randomization|||blood units||Standard Deviation|Mean
823054|NCT01167582|Secondary|Composite Mortality and Morbidity|Composite rates of all cause mortality, or myocardial infarction (recurrent if had ST segment or Non ST segment MI or new myocardial infarction), or unscheduled coronary revascularization and pneumonia.|30 days and 6 months||||||
823055|NCT01167582|Secondary|Pneumonia or Blood Stream Infection and Each Separately||30 days and 6 months||||||
823056|NCT01167582|Secondary|Deep Vein Thrombosis and Pulmonary Embolism||30 days and 6 months||||||
823057|NCT01167582|Secondary|Stent Thrombosis||30 days and 6 months||||||
823058|NCT01167582|Secondary|Congestive Heart Failure||30 days and 6 months||||||
823059|NCT01167582|Secondary|Stroke||30 days and 6 months||||||
823060|NCT01167582|Secondary|Unscheduled Hospital Admission|Unscheduled hospital admission at 30 days and 6 months for any reason, for cardiac reason (e.g., acute coronary syndrome, MI, congestive heart failure, or arrhythmia), or infection.|30 days and 6 months||||||
823061|NCT01167582|Secondary|Mortality From Cardiac Causes||30 days and 6 months||||||
823062|NCT01167582|Secondary|Individual Components of Composite Outcome|All cause mortality Myocardial infarction (recurrent if had ST segment or Non ST segment MI or new myocardial infarction) Unscheduled coronary revascularization.|30 days and 6 months||||||
823063|NCT01167582|Secondary|Mortality or Myocardial Ischemia|Composite 6 month rates of all cause 6 month mortality, recurrent myocardial infarction up to 6 months after randomization, unscheduled coronary revascularization within 6 months.|6 months|||participants|||Number
823064|NCT01167582|Secondary|Mortality or Myocardial Ischemia|Composite 30 day rates of all cause 30 day mortality, or myocardial infarction (recurrent if had ST segment or Non ST segment MI or new myocardial infarction) up to 30 days after randomization, or unscheduled coronary revascularization within 30 days.|30 days|||participants|||Number
823065|NCT01167582|Primary|Hemoglobin Concentration|Differences in the mean hemoglobin concentrations between the two study arms.|In-hospital up to 30 days post randomization|||g/dL||Standard Deviation|Mean
823066|NCT01167582|Primary|Trial Feasibility|"the number of eligible study subjects and enrollment rates, overall and by center;
the adherence rates for the transfusion protocol, overall and by center;
the frequencies of proposed outcomes"|6 months||||||
823067|NCT01167608|Primary|"3rd Most Commonly Reported Future Barrier to Mental Health Services: Services Are Not Available in my Community"|"The purpose of this study was to assess the 3 most commonly reported past and future barriers to mental health services. This outcome represents the 3rd most common future barrier to mental health service reported by respondents to the survey described in the Methods section. Outcome is reported as the percentage of all respondents surveyed who endorsed this particular future barrier. This barrier can best be described as limited access.
NOTE: This is an anonymous, cross-sectional survey study. Not all participants responded to every item, so sample size varies between outcome measures."|Lifetime|||percentage of total respondents|||Number
823090|NCT01167881|Secondary|The Change in Systolic Blood Pressure (SBP) From Baseline After 104 Weeks of Treatment.||baseline and 104 weeks|FAS (LOCF-H) – Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF); Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.||mmHg||Standard Error|Mean
823091|NCT01167881|Secondary|The Occurrence of Confirmed Hypoglycaemic Events During 104 Weeks of Treatment.||baseline and 104 weeks|Treated set, all patients treated with at least one dose of randomised study drug.||participants|||Number
823069|NCT01167608|Primary|"Most Commonly Reported Future Barrier to Mental Health Services: Out of Pocket Cost Was Too High"|"The purpose of this study was to assess the 3 most commonly reported past and future barriers to mental health services. This outcome represents the most common future barrier to mental health service reported by respondents to the survey described in the Methods section. Outcome is reported as the percentage of all respondents surveyed who endorsed this particular future barrier. This barrier can best be described as limited access.
NOTE: This is an anonymous, cross-sectional survey study. Not all participants responded to every item, so sample size varies between outcome measures."|Lifetime|||percentage of total respondents|||Number
823070|NCT01167608|Primary|"3rd Most Commonly Reported Past Barrier to Mental Health Services: Out of Pocket Cost Was Too High"|"The purpose of this study was to assess the 3 most commonly reported past and future barriers to mental health services. This outcome represents the 3rd most common past barrier to mental health services reported by survey respondents. The outcome reported is the percentage of all respondents surveyed who endorsed this particular past barrier. This barrier can best be described as limited access.
NOTE: This is an anonymous, cross-sectional survey study. Not all participants responded to every item, so sample size varies between outcome measures."|Lifetime|||percentage of total respondents|||Number
823071|NCT01167608|Primary|"2nd Most Commonly Reported Past Barrier to Mental Health Services: Doctors Are Not Sensitive Enough to PD-related Issues"|"The purpose of this study was to assess the 3 most commonly reported past and future barriers to mental health services. This outcome represents the 2nd most common past barrier to mental health services reported by survey respondents. The outcome reported is the percentage of all respondents surveyed who endorsed this particular past barrier. This barrier can best be described as limited knowledge of PD amongst treatment providers.
NOTE: This is an anonymous, cross-sectional survey study. Not all participants responded to every item, so sample size varies between outcome measures."|Lifetime|||percentage of total respondents|||Number
823072|NCT01167608|Primary|"Most Commonly Reported Past Barrier to Mental Health Services: Anyone in my Situation Would be Struggling"|"The purpose of this study was to assess the 3 most commonly reported past and future barriers to mental health services. This outcome represents the most common past barrier to mental health services reported by survey respondents. The outcome reported is the percentage of all respondents surveyed who endorsed this particular past barrier. This barrier can best be described as low mental health literacy.
NOTE: This is an anonymous, cross-sectional survey study. Not all participants responded to every item, so sample size varies between outcome measures."|Lifetime|||percentage of total respondents|||Number
823073|NCT01167634|Primary|Change in Weight|Change in weight between baseline and 24 weeks|24 Weeks|||pounds||Standard Deviation|Mean
823074|NCT01167829|Secondary|Free Testosterone Mean Concentration|Free T normal range 4.7-18 ng/dL|baseline & day 9|per protocol||ng/dL||Geometric Coefficient of Variation|Geometric Mean
823075|NCT01167829|Secondary|Free T Maximum Concentration|Free T normal range 4.7-18 ng/dL|baseline & day 9|per protocol||ng/dL||Geometric Coefficient of Variation|Geometric Mean
823076|NCT01167829|Secondary|Mean Estradiol Concentration||baseline & day 9|per protocol||ng/dL||Geometric Coefficient of Variation|Geometric Mean
823077|NCT01167829|Secondary|Maximum Estradiol Concentration||baseline & day 9|per protocol||ng/dL||Geometric Coefficient of Variation|Geometric Mean
823078|NCT01167829|Secondary|Mean SHGB Concentration||baseline & day 9|per protocol||ng/dL||Geometric Coefficient of Variation|Geometric Mean
823079|NCT01167829|Secondary|Maximum Sex Hormone-Binding Globulin (SHGB)Concentration||baseline & day 9|||ng/dL||Geometric Coefficient of Variation|Geometric Mean
823080|NCT01167829|Secondary|Mean Dihydrotestosterone (DHT) Concentration||baseline & day 9|per protocol||ng/dL||Geometric Coefficient of Variation|Geometric Mean
823081|NCT01167829|Secondary|Maximum Dihydrotestosterone (DHT) Concentration||baseline & day 9|per protocol||ng/dL||Geometric Coefficient of Variation|Geometric Mean
823082|NCT01167829|Primary|Mean Testosterone Concentration|initial 24-hour pharmacokinetics (PK) of oral testosterone dosed 3 times daily and post 24-hour PK after 9 days of treatment|baseline & day 9|per protocol||ng/dL||Geometric Coefficient of Variation|Geometric Mean
823083|NCT01167829|Primary|Maximum Testosterone Concentration|initial pharmacokinetics [PK] (day 1) of oral testosterone dosed 3 times daily and the PK after 9 days of treatment|baseline & day 9|per protocol||ng/dL||Geometric Coefficient of Variation|Geometric Mean
823084|NCT01167881|Secondary|The Change in Diastolic Blood Pressure (DBP) From Baseline After 52 Weeks of Treatment.||baseline and 52 weeks|FAS (LOCF-H) – Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF); Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.||mmHg||Standard Error|Mean
823085|NCT01167881|Secondary|The Change in Systolic Blood Pressure (SBP) From Baseline After 52 Weeks of Treatment.||baseline and 52 weeks|FAS (LOCF-H) – Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF); Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.||mmHg||Standard Error|Mean
823086|NCT01167881|Secondary|The Occurrence of Confirmed Hypoglycaemic Events During 52 Weeks of Treatment.||baseline and 52 weeks|Treated set, all patients treated with at least one dose of randomised study drug.||participants|||Number
823087|NCT01167881|Secondary|The Change in Body Weight From Baseline After 52 Weeks of Treatment.||baseline and 52 weeks|FAS (LOCF) – Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF); Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.||kilograms||Standard Error|Mean
823088|NCT01167881|Secondary|The Change From Baseline in HbA1c After 52 Weeks of Treatment.||baseline and 52 weeks|FAS (LOCF) – Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF); Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.||percentage of HbA1c||Standard Error|Mean
823089|NCT01167881|Secondary|The Change in Diastolic Blood Pressure (DBP) From Baseline After 104 Weeks of Treatment.||baseline and 104 weeks|FAS (LOCF-H) – Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF); Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.||mmHg||Standard Error|Mean
823093|NCT01167881|Secondary|The Change in Body Weight From Baseline After 104 Weeks of Treatment.||baseline and 104 weeks|FAS (LOCF) – Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF); Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.||kilograms||Standard Error|Mean
823094|NCT01168024|Secondary|Change in Kidney Function Between the Randomized Groups.||Up to 96 hours post-procedure|Change in eGFR was available for 2 treatment and 1 control subject. 1 out of range eGFR value for a subject (0.1) was not used as this value is not clinically feasible.||mL/min/1.73m^2||Standard Deviation|Mean
823095|NCT01168024|Primary|Evaluating Local Events.|"Events evaluated include:
Coronary sinus perforation, dissection, or occlusion that requires treatment or results in MI or death
Pericardial effusions (including pericardial tamponade) requiring treatment"|Through 30 days post-procedure.|||events|||Number
823096|NCT01168024|Primary|Evaluating Bleeding/Transfusion Events.|"Bleeding/transfusion events evaluated:
Blood loss requiring transfusion of ≥ 2 units
Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding
TIMI Minor Bleeding"|Through 30 days post-procedure|||events|||Number
823097|NCT01168024|Primary|Incidence of Contrast Induced Nephropathy (CIN) in Subjects.|CIN is defined as a post-procedure relative serum creatinine increase ≥ 25% or an absolute serum creatinine increase of ≥ 0.5 mg/dL).|Through 72 hours post-procedure|||participants|||Number
823098|NCT01168232|Secondary|Overall Survival|Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.|From study entry to death or last contact, up to 5 years of follow-up.|Eligible and Treated Patients||months||95% Confidence Interval|Median
823099|NCT01168232|Secondary|Progression-free Survival|Progression-free survival is the period of time from study entry to time of disease progression, death or date of last contact, whichever occurs first. Progression is assessed by RECIST 1.1|From study entry to disease progression, death or date of last contact, whichever occurs first, up to 5 years of follow-up.|Eligible and Treated Patients||months||95% Confidence Interval|Median
823100|NCT01168232|Primary|Adverse Events (Grade 3 or Higher) During Treatment Period.|Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v4.0|During treatment and up to 30 days after stopping the study treatment|Eligible and Treated Participants||participants|||Number
823101|NCT01168232|Primary|Objective Tumor Response|Proportion of participants with objective tumor response. Objective tumor response is defined as complete or partial tumor response as assessed by RECIST 1.1.|Every other cycle for first 6 months; then every 3 months thereafter until completion of study treatment; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.1 cycle is 21 days|Eligible and Treated Patients. Measure of dispersion is 95% One-sided confidence Interval||percentage||95% Confidence Interval|Number
823102|NCT01168349|Secondary|Percentage of Participants With Vitamins Prescription||Week 4 to 6, Week 12 to 16, Week 24 to 48|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure and “n” included participants who were evaluable at specified time point for each arm, respectively.||percentage of participants|||Number
823103|NCT01168349|Secondary|Percentage of Participants With Adequate Iron Status|Criteria for adequate iron status included serum ferritin greater than (>) 100 micrograms/liter (µg/L) and transferrin saturation (TSAT)> 20%.|Baseline, Week 4 to 6, Week 12 to 16, Week 24 to 48|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure and “n” included participants who were evaluable at specified time point for each arm, respectively.||percentage of participants|||Number
823104|NCT01168349|Secondary|Percentage of Participants With Hb Concentration Within the Range of 10 to 12 g/dL||Baseline up to Week 28|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.||percentage of participants|||Number
823105|NCT01168349|Secondary|Relative Percent Change in Hb Concentration From Baseline Over the Study Period||Baseline, Week 4 to 6, Week 12 to 16, Week 24 to 28|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure and “n” included participants who were evaluable at specified time point for each arm, respectively.||percent change||Standard Deviation|Mean
823106|NCT01168349|Secondary|Percentage of Participants With Permanent Discontinuation From NeoRecormon® Treatment||Baseline up to Week 4 to 6, Week 12 to 16, Week 24 to 28|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure and “n” included participants who were evaluable at specified time point for each arm, respectively.||percentage of participants|||Number
823107|NCT01168349|Secondary|Percentage of Participants With Temporary Discontinuation From NeoRecormon® Treatment|Percentage of participants with at least 1 temporary discontinuation was reported.|Baseline up to Week 28|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.||percentage of participants|||Number
823108|NCT01168349|Secondary|Percentage of Participants With Modifications of NeoRecormon® Regimen|All modifications were based on the change in frequency, route of administration or dose depending on the need for treatment adjustments according to Hb concentration. Percentage of participants with at least 1 modification in NeoRecormon® regimen was reported.|Baseline up to Week 28|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.||percentage of participants|||Number
823109|NCT01168349|Secondary|Percentage of Participants With NeoRecormon® SC Injections at a Weekly Dose of 30000 IU||Baseline up to Week 28|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.||percentage of participants|||Number
823110|NCT01168349|Secondary|Percentage of Participants With Subcutaneous (SC) Route of Administration||Baseline, Week 4 to 6, Week 12 to 16, Week 24 to 48|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure and “n” included participants who were evaluable at specified time point for each arm, respectively.||percentage of participants|||Number
823167|NCT01163149|Primary|Change From Baseline to Week 24 for Plasma Inorganic Pyrophosphate (PPi)|Blood samples were collected to evaluate the effect of asfotase alfa on reduction in plasma inorganic pyrophosphate (PPi)|Baseline, Week 24|Full analysis set (intent-to-treat, all randomized patients)||uM||Standard Deviation|Mean
823111|NCT01168349|Secondary|Percentage of Participants With Pre-specified Dose and Frequency of Injections|Pre-specified doses and frequency included; 20000 IU/week - Once a week (qw), 30000 IU/week -qw, 30000 IU/week - Twice a week (tw), 30000 IU/week - Once every 2 weeks (q2w), 40000 IU/week - qw, 60000 IU/week - qw, and other. Missing data were not reported.|Baseline, Week 4 to 6, Week 12 to 16, Week 24 to 48|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure and “n” included participants who were evaluable at specified time point for each arm, respectively.||percentage of participants|||Number
823112|NCT01168349|Secondary|Percentage of Participants With Starting Dose Between 360 and 540 IU/kg/Weeks||Baseline|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.||percentage of participants|||Number
823113|NCT01168349|Secondary|Mean Starting Dose of NeoRecormon® Injection|Dose of NeoRecormon® injection was measured in international units/kilograms/weeks (IU/kg/weeks).|Baseline|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.||IU/kg/weeks||Standard Deviation|Mean
823114|NCT01168349|Primary|Self-Reported Questionnaire: Change From Baseline on the Impact of Health on Regular Activities at Week 24 to 28|Self-administered questionnaire, WPAI questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 6 asked participants to indicate how much their anemia affected their ability to do their regular daily activities such as housework, childcare, exercising, shopping, studying and so on, in the past 7 days on a scale from 0 (no effect) to 10 (completely prevented from doing daily activities).|Baseline, Week 24 to 28|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.||units on a scale||Standard Deviation|Mean
823115|NCT01168349|Primary|Self-Reported Questionnaire: Change From Baseline on the Impact of Health on Regular Activities at Week 12 to 16|Self-administered questionnaire, WPAI questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 6 asked participants to indicate how much their anemia affected their ability to do their regular daily activities such as housework, childcare, exercising, shopping, studying and so on, in the past 7 days on a scale from 0 (no effect) to 10 (completely prevented from doing daily activities).|Baseline, Week 12 to 16|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.||units on a scale||Standard Deviation|Mean
823116|NCT01168349|Primary|Self-Reported Questionnaire: Change From Baseline on the Impact of Health on Regular Activities at Week 4 to 6|Self-administered questionnaire, WPAI questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 6 asked participants to indicate how much their anemia affected their ability to do their regular daily activities such as housework, childcare, exercising, shopping, studying and so on, in the past 7 days on a scale from 0 (no effect) to 10 (completely prevented from doing daily activities).|Baseline, Week 4 to 6|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.||units on a scale||Standard Deviation|Mean
823117|NCT01168349|Primary|Self-Reported Questionnaire: Percentage of Participants With Current Employment at Week 24 to 28|Self-administered questionnaire, WPAI questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 1 asked participants to indicate if they were currently employed or working for pay (Yes or No). Data reported for the outcome included those who were employed.|Week 24 to 28|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.||percentage of participants|||Number
823118|NCT01168349|Primary|Self-Reported Questionnaire: Percentage of Participants With Current Employment at Week 12 to 16|Self-administered questionnaire, WPAI questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 1 asked participants to indicate if they were currently employed or working for pay (Yes or No). Data reported for the outcome included those who were employed.|Week 12 to 16|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.||percentage of participants|||Number
823119|NCT01168349|Primary|Self-Reported Questionnaire: Percentage of Participants With Current Employment at Week 4 to 6|Self-administered questionnaire, WPAI questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 1 asked participants to indicate if they were currently employed or working for pay (Yes or No). Data reported for the outcome included those who were employed.|Week 4 to 6|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.||percentage of participants|||Number
823120|NCT01168349|Primary|Self-Reported Questionnaire: Percentage of Participants With Current Employment at Baseline|Self-administered questionnaire, work productivity and activity impairment (WPAI) questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 1 asked participants to indicate if they were currently employed or working for pay (Yes or No). Data reported for the outcome included those who were employed.|Baseline|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.||percentage of participants|||Number
823121|NCT01168349|Primary|Mean Number of Days of Sick Leave|Sick leaves was described in active participants at inclusion (professional activity: active, in sick leave or unemployed participants).|Week 4 Up to Week 28|Efficacy population. Here “number of participants analyzed” included those participants who had at least 1 sick leave without any missing data.||days||Standard Deviation|Mean
823122|NCT01168349|Primary|Percentage of Participants With At Least 1 Sick Leave|Sick leaves was described in active participants at inclusion (professional activity: active, in sick leave or unemployed participants).|Week 4 Up to Week 28|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.||percentage of participants|||Number
823123|NCT01168349|Primary|Percentage of Participants With Professional Activity: Baseline|Percentage of participants with professional activity was assessed based on the number of participants with early response or not at Day 21 to 42. Professional activity was categorized as active; disability; no occupation; retired; sick leave; student, training; and unemployment.|Baseline|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.||percentage of participants|||Number
823124|NCT01168349|Primary|KPS: Week 24 to 28|KPS was used to quantify participant’s general well-being and activities of daily life and participants were classified based on their functional impairment. An 11-level score, KPS score ranged between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks. KPS was based on the number of participants with early response.|Week 24 to 28|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.||units on a scale||Standard Deviation|Mean
823125|NCT01168349|Primary|KPS: Week 12 to 16|KPS was used to quantify participant’s general well-being and activities of daily life and participants were classified based on their functional impairment. An 11-level score, KPS score ranged between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks. KPS was based on the number of participants with early response.|Week 12 to 16|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.||units on a scale||Standard Deviation|Mean
823126|NCT01168349|Primary|KPS: Week 4 to 6|KPS was used to quantify participant’s general well-being and activities of daily life and participants were classified based on their functional impairment. An 11-level score, KPS score ranged between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks. KPS was based on the number of participants with early response.|Week 4 to 6|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.||units on a scale||Standard Deviation|Mean
823127|NCT01168349|Primary|Karnofsky Performance Status (KPS): Baseline|KPS was used to quantify participant’s general well-being and activities of daily life and participants were classified based on their functional impairment. An 11-level score, KPS score ranged between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks. KPS was based on the number of participants with early response.|Baseline|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.||units on a scale||Standard Deviation|Mean
823128|NCT01168349|Primary|Time to First RBC Transfusions|Time to first RBC transfusion was assessed based on the number of participants with early response or not at Day 21 to 42. Early treatment response was defined as an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation. Kaplan-Meier estimate was used.|Baseline up to Week 28|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.||weeks||95% Confidence Interval|Median
823129|NCT01168349|Primary|Mean Number of RBC Units|Mean number of units was based on the number of participants with at least 1 RBC transfusion.|Baseline up to Week 28|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure without any missing data.||RBC units||Standard Deviation|Mean
823130|NCT01168349|Primary|Mean Number of RBC Transfusions|Mean number of transfusion was based on the number of participants with at least 1 RBC transfusion.|Baseline up to Week 28|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure without any missing data.||RBC transfusions||Standard Deviation|Mean
823131|NCT01168349|Primary|Percentage of Participants With At Least 1 Red Blood Cell (RBC) Transfusion|Participants with at least 1 RBC transfusion was assessed based on the number of participants with early response or not at Day 21 to 42. Early treatment response was defined as an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.|Baseline up to Week 28|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.||percentage of participants|||Number
823132|NCT01168349|Primary|Percentage of Participants With Early Treatment Response: Day 21 to 42|Early treatment response was defined as an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.|Day 21 to 42|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.||percentage of participants||95% Confidence Interval|Number
823133|NCT01168349|Primary|Percentage of Participants With Early Treatment Response: Day 28 to 42|Early treatment response was defined as an increase of Hemoglobin (Hb) concentration of at least 1 gram/deciliter (g/dL), 4 to 6 weeks after treatment initiation.|Day 28 to 42|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.||percentage of participants||95% Confidence Interval|Number
823134|NCT01168427|Secondary|R-wave Amplitude Measurement|Average R-wave amplitude at implant and 30-days post procedure|Implant procedure and 30 days post-implant procedure||09/2012||||
823135|NCT01168427|Secondary|Physician Satisfaction With Reveal In-office Implants|Observational survey of physicians satisfaction post implant At implant|At implant||09/2012||||
823136|NCT01168427|Secondary|Techniques and Procedures Utilized During Reveal In-office Implants|Observational data collection as to the technics and procedures utilized during all implants including (but not limited to): device orientation, suturing, wound closure, instrument and material use, and time.|At implant||09/2012||||
823137|NCT01168427|Secondary|Surgical Staff Utilized for Reveal In-office Implants|Observational analysis of surgical staff present at the Reveal Implants|At implant||09/2012||||
823138|NCT01168427|Secondary|Number of Participants Having Procedure-related Adverse Events|Report number of participants having procedure-related adverse events that meet the primary endpoint (requiring surgical intervention), and number of participants having other procedure-related adverse events (not requiring surgical intervention).|From Implant to 90 days post-implant procedure|||participants|||Number
823139|NCT01168427|Primary|Procedure-related Complications Rate Requiring Resolution by Surgical Intervention|This objective estimates the proportion of patients having procedure-related complication requiring resolution by surgical intervention at 90 days post-implant procedure using Kaplan-Meier method.|From Implant to 90 days post-implant procedure|Reveal device indicated patients, enrolled in the study and implanted per protocol||participants|||Number
823140|NCT01168596|Other Pre-specified|Visual Analog Scale - Subset: Tense|The Visual Analog Scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The severity of attitude at the time of testing is marked with a cross along a 10 cm line (labeled neutral to afraid, confused, sad, angry, energetic, tired, happy or tense). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptoms-free) to 10 (symptom severe).|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.||units on a scale||95% Confidence Interval|Mean
823141|NCT01168596|Other Pre-specified|Visual Analog Scale - Subset: Happy|The Visual Analog Scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The severity of attitude at the time of testing is marked with a cross along a 10 cm line (labeled neutral to afraid, confused, sad, angry, energetic, tired, happy or tense). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptoms-free) to 10 (symptom severe).|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.||units on a scale||95% Confidence Interval|Mean
823142|NCT01168596|Other Pre-specified|Visual Analog Scale - Subset: Tired|The Visual Analog Scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The severity of attitude at the time of testing is marked with a cross along a 10 cm line (labeled neutral to afraid, confused, sad, angry, energetic, tired, happy or tense). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptoms-free) to 10 (symptom severe).|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.||units on a scale||95% Confidence Interval|Mean
823143|NCT01168596|Other Pre-specified|Visual Analog Scale - Subset: Energetic|The Visual Analog Scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The severity of attitude at the time of testing is marked with a cross along a 10 cm line (labeled neutral to afraid, confused, sad, angry, energetic, tired, happy or tense). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptoms-free) to 10 (symptom severe).|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.||units on a scale||95% Confidence Interval|Mean
823144|NCT01168596|Other Pre-specified|Visual Analog Scale - Subset: Angry|The Visual Analog Scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The severity of attitude at the time of testing is marked with a cross along a 10 cm line (labeled neutral to afraid, confused, sad, angry, energetic, tired, happy or tense). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptoms-free) to 10 (symptom severe).|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.||units on a scale||95% Confidence Interval|Mean
823145|NCT01168596|Other Pre-specified|Visual Analog Scale - Subset: Sad|The Visual Analog Scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The severity of attitude at the time of testing is marked with a cross along a 10 cm line (labeled neutral to afraid, confused, sad, angry, energetic, tired, happy or tense). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptoms-free) to 10 (symptom severe).|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.||units on a scale||95% Confidence Interval|Mean
823146|NCT01168596|Other Pre-specified|Visual Analog Scale - Subset: Confused|The Visual Analog Scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The severity of attitude at the time of testing is marked with a cross along a 10 cm line (labeled neutral to afraid, confused, sad, angry, energetic, tired, happy or tense). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptoms-free) to 10 (symptom severe).|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.||units on a scale||95% Confidence Interval|Mean
824922|NCT01178671|Secondary|PTSD Self-rated Severity|as measured by the PTSD Checklist which rates severity of PTSD from 17 (least severe) to 85 (most severe).|up to 24 weeks|completers||units on a scale||Standard Deviation|Mean
823147|NCT01168596|Other Pre-specified|Unified Parkinson's Disease Rating Scale - Motor (UPDRS Part III)|Unified Parkinson's Disease Rating Scale - Motor (UPDRS Part III)is a 14-question inventory measuring the motor functions of patients with Parkinson's Disease. Each subject is rated on a scale of 0 to 4 with the total score from 0 to 56. Higher total scores indicate more impairment of motor function.|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.||units on a scale||95% Confidence Interval|Mean
823148|NCT01168596|Other Pre-specified|Becks Depression Inventory (BDI-II)|The Becks Depression Inventory (BDI-II) is a 21-question inventory measuring the severity of depression. Each subject is instructed to choose an answer on a scale value of 0 to 3 with the total score from 0 to 63. Higher total scores indicate more severe depressive symptoms.|Change from baseline to week 12|||units on a scale||95% Confidence Interval|Mean
823149|NCT01168596|Other Pre-specified|State-Trait Anxiety Inventory (STAI)|The State-Trait Anxiety Inventory (STAI) is 40-item psychological inventory based on a 4-point Likert scale. Higher scores are positively correlated with higher levels of anxiety. The range for this test is 0 to 160.|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.||units on a scale||95% Confidence Interval|Mean
823150|NCT01168596|Other Pre-specified|Visual Analog Scale - Subset: Afraid|The Visual Analog Scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The severity of attitude at the time of testing is marked with a cross along a 10 cm line (labeled neutral to afraid, confused, sad, angry, energetic, tired, happy or tense). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptoms-free) to 10 (symptom severe).|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.||units on a scale||95% Confidence Interval|Mean
823151|NCT01168596|Other Pre-specified|Marin Apathy Inventory (Apathy Evaluation Scale)|The Marin Apathy Inventory (Apathy Evaluation Scale) is a 14-item inventory measuring apathy of the subject over the past 2 to 4 weeks. Subjects are instructed to choose an answer from 0 to 3: 0=not at all, 1 = slightly, 2 = some, 3 = a lot, to questions related to apathy. The range would be 0 to 42, the higher the score the worse the apathy.|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.||units on a scale||95% Confidence Interval|Mean
823152|NCT01168596|Other Pre-specified|Parkinson's Disease Sleep Scale (PDSS)|The Parkinson's disease sleep scale (PDSS) is a 15-item visual analogue scale that assesses the profile of nocturnal disturbances in Parkinson's disease patients. The severity of symptoms of sleep over the past week is marked with a cross along a 10 cm line (labeled worst to best state). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptom severe and always experienced) to 10 (symptom-free). The maximum score for PDSS is 150.|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.||units on a scale||95% Confidence Interval|Mean
823153|NCT01168596|Secondary|Hand-grip Strength|The patients use the hand on the side most affected by Parkinson’s disease to grip the dynamometer with as much strength as they can for 3 consecutive tries. The highest score will be their maximal voluntary contraction (MVC). The subject then rests for 60 seconds. The subject is asked to try to maintain 70% of their MVC and the duration the subject is able to maintain above 50% of their MVC is recorded. Immediately after the maintenance test, the subject performs three more MVCs and each one is recorded. These results are the duration the subject is able to maintain above 50% of their MVC.|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.||seconds||95% Confidence Interval|Mean
823154|NCT01168596|Secondary|Finger Tapping|The patient is asked to use the index finger on the side most affected by Parkinson’s disease to tap for sixty seconds with the number of taps at 30 seconds and 60 seconds recorded.|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.||finger taps per sixty seconds||95% Confidence Interval|Mean
823155|NCT01168596|Secondary|Paced Auditory Serial Addition Test (PASAT)|The Paced Auditory Serial Addition Test (PASAT) is a neuropsychological test used to assess capacity and rate of information processing and sustained and divided attention. Where subjects are given a number (every 3 seconds for the first series and 2 seconds for the second series) and are asked to add the number they just heard with the number they heard before. This is a challenging task that involves working memory, attention, and arithmetic capabilities.|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.||units on a scale||95% Confidence Interval|Mean
823168|NCT01163149|Primary|Change From Baseline to Week 24 for Plasma Pyridoxal-5' Phosphate (PLP)|Blood samples were collected to evaluate the effect of asfotase alfa on reduction in plasma pyridoxal-5' phosphate (PLP)|Baseline, Week 24|Full analysis set (intent-to-treat, all randomized patients)||ng/mL||Standard Deviation|Mean
823169|NCT01163162|Primary|24-hour Urine Creatinine Excretion Rate|We expect the 24 hour urine creatinine excretion rate to show no differences between groups.|1 Week|||mg/24hour/day||95% Confidence Interval|Mean
823170|NCT01163162|Secondary|Serum Creatinine|We expect serum creatinine to confirm the results of creatinine clearance.|1 Week|||mg/dl/day||95% Confidence Interval|Mean
823156|NCT01168596|Secondary|PD Quality of Life Scale (PDQ39)|PD Quality of Life Scale (PDQ39) is a 39-item questionnaire, which measures eight dimensions of health (mobility, activities of daily living, emotional well-being, stigma, social support, cognitions, communication and bodily discomfort) over the past 30 days. Dimension scores are coded on a scale of 0 (never) to 5 (always). The higher the score, the worse the quality of life affected by PD. The range for this test is 0 to 195. All eight dimensions are added for a total score.|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.||units on a scale||95% Confidence Interval|Mean
823157|NCT01168596|Secondary|Multidimensional Fatigue Inventory (MFIS)|The Multidimensional Fatigue Inventory (MFIS) is a 20-item self-report instrument designed to measure fatigue. It covers the following dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation and reduced activity. Subjects are instructed to choose a number from 1 to 5 that indicates their degree of agreement with each statement where 1 indicates that it is true and 5 that it is not true. There are positive and negative statements in the questionnaire. The range is 1 to 100, the higher the number the higher the fatigue.|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.||units on a scale||95% Confidence Interval|Mean
823158|NCT01168596|Secondary|Fatigue Severity Scale (FSS)|The Fatigue Severity Score consists of a nine-item questionnaire to identify common features of fatigue. Patients are instructed to choose a number from 1 to 7 that indicates their degree of agreement with each statement, where 1 = strongly disagree and 7 = strongly agree. Scores can range from a minimum of 9 to a maximum of 63. The higher the score, the more fatigue the subject.|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.||units on a scale||95% Confidence Interval|Mean
823159|NCT01168596|Primary|Modified Fatigue Impact Scale (MFIS)|The MFIS rates how much of a problem fatigue has caused the subjects during the past month, including the day of testing. It consists of 21 questions of fatigue on quality of life. Each subject is asked to circle the appropriate response for each item: 0=never, 1=rarely, 2=sometimes, 3=often, 4=always, 5=almost always. The minimum score is 0 and the maximum is 105. The higher the score, the more fatigue the subject.|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.||units on a scale||95% Confidence Interval|Mean
823160|NCT01163149|Secondary|Change From Baseline in HPP-related Osteomalacia as Measured by Trans-iliac Crest Bone Biopsy: Mineralization Lag Time|A trans-iliac crest bone biopsy was performed to quantify changes from Baseline in histomorphometric parameters relevant for evaluation of osteomalacia severity, including Mineralization Lag Time (days). The difference in time under observation between asfotase alfa groups (Week 48) and control group (Week 24) resulted from study design, ie, control subjects transitioned to active treatment after the Week 24 visit.|Baseline, Week 24 (Control group), and Week 48 (Asfotase alfa groups).|Full analysis set (intent-to-treat, all randomized patients)||days||Standard Deviation|Mean
823161|NCT01163149|Secondary|Change From Baseline in HPP-related Osteomalacia as Measured by Trans-iliac Crest Bone Biopsy: Osteoid Thickness|A trans-iliac crest bone biopsy was performed to quantify changes from Baseline in histomorphometric parameters relevant for evaluation of osteomalacia severity, including Osteoid Thickness (um). The difference in time under observation between asfotase alfa groups (Week 48) and control group (Week 24) resulted from study design, ie, control subjects transitioned to active treatment after the Week 24 visit.|Baseline, Week 24 (Control group), and Week 48 (Asfotase alfa groups).|Full analysis set (intent-to-treat, all randomized patients)||um||Standard Deviation|Mean
823162|NCT01163149|Secondary|Change From Baseline in HPP-related Osteomalacia as Measured by Trans-iliac Crest Bone Biopsy: Osteoid Volume/Bone Volume|A trans-iliac crest bone biopsy was performed to quantify changes from Baseline in histomorphometric parameters relevant for evaluation of osteomalacia severity, including Osteoid Volume/Bone Volume (%). The difference in time under observation between asfotase alfa groups (Week 48) and control group (Week 24) resulted from study design, ie, control subjects transitioned to active treatment after the Week 24 visit.|Baseline, Week 24 (Control group), and Week 48 (Asfotase alfa groups).|Full analysis set (intent-to-treat, all randomized patients)||percentage of volume||Standard Deviation|Mean
823163|NCT01163149|Secondary|Change in Walking Ability as Measured by the Six-Minute Walk Test (6MWT)|The patient was instructed to walk the length of a pre-measured hallway for 6 minutes. The primary measurement was distance walked (in meters).|Baseline, Week 24 (primary treatment period) and up to 288 weeks of asfotase alfa exposure|Full analysis set (intent-to-treat, all randomized patients). Among the 6 control subjects, only 4 had both a Baseline and Week 24 value.||meters||Standard Deviation|Mean
823164|NCT01163149|Secondary|Change From Baseline in Bone Mineral Density (BMD) as Measured by Dual-energy X-ray Absorptiometry (DXA)|A DXA scan was performed to evaluate bone bone mineral density (BMD) of the spine, hip, and whole body during the primary (first 24 weeks) and extension treatment periods (up to 288 weeks).|Baseline, every 24 weeks through Week 96, then every 48 weeks until Week 288.|Full analysis set (intent-to-treat, all randomized patients)||g/cm2||Standard Deviation|Mean
823165|NCT01163149|Secondary|Change From Baseline in Bone Mineral Content (BMC) as Measured by Dual-energy X-ray Absorptiometry (DXA)|A DXA scan was performed to evaluate bone mineral content (BMC) of the spine, hip, and whole body during the primary (first 24 weeks) and extension treatment periods (up to 288 weeks).|Baseline, every 24 weeks through Week 96, then every 48 weeks until Week 288.|Full analysis set (intent-to-treat, all randomized patients)||g||Standard Deviation|Mean
823166|NCT01163149|Primary|Safety and Tolerability of Asfotase Alfa|The safety and tolerability of daily subcutaneous (SC) injections of asfotase alfa was assessed by routine monitoring of patients for treatment-emergent adverse events (TEAEs) and injection-associated reactions (IARs).|Up to 288 weeks exposure to asfotase alfa|Safety Set. Control group and asfotase alfa Cohorts during the primary treatment period (first 24 weeks of study); all patients with asfotase alfa exposure during open-label extension treatment period.||Number of Treatment-Emergent Events|||Number
823172|NCT01163214|Secondary|Number of Subjects Who Experienced Neurological Changes Postoperatively|Participants were questioned at the 6 weeks follow-up visit regarding any neurological changes that were not present preoperatively.|6 weeks postoperative|The number of participants analyzed in the nerve block arm varied because data were not available for all participants in all neurological categories. The sample size for the periarticular injection arm was 79 because neurological data were not collected on 2 participants.||participants|||Number
823173|NCT01163214|Secondary|Length of Stay in Hospital|Length of stay data were calculated from the medical record.|Approximately 2 days after surgery|The number of participants analyzed were different than the baseline values for the arms because data were not available for some participants.||days||Standard Deviation|Mean
823174|NCT01163214|Secondary|Straight-leg Raise|Post-operative quadriceps function was measured by the number of participants who could perform a straight-leg raise.|Day 1 morning (AM), Day 1 afternoon (PM), Day 2 morning, Day 2 afternoon|The number of participants analyzed varied at each category time point because either data points were missing for participants, or as the condition of the participants improved, they were discharged from the hospital. Number of participants per arm for each time point is shown in each category label.||participants|||Number
823175|NCT01163214|Secondary|Narcotic Use|Use of additional narcotic medications (as needed), measured in morphine equivalents.|Intraoperative, Day of surgery, Post-Operative Day 1, Post-Operative Day 2|Intention to treat analysis||mg||Standard Deviation|Mean
823176|NCT01163214|Primary|Post-Operative Pain|Pain was measured using a linear analog scale for pain, with a scale from 0 (no pain) to 10 points (worst possible pain).|Afternoon on post-operative Day 1, approximately 14:00|Intention to treat analysis||units on a scale||Standard Deviation|Mean
823177|NCT01163214|Secondary|Pain Scores in the Per-protocol Subset (Participants Who Received the Allocated Treatment)|Pain was measured using a linear analog scale for pain, with a scale from 0 (no pain) to 10 points (worst possible pain).|Afternoon on post-operative Day 1, approximately 14:00|In the nerve block arm 5 subjects were excluded (3 subjects were not treated as planned, and 1 subject received a sciatic catheter instead of a single injection, and 1 subject previously had a nerve block procedure.) In the periarticular injection arm 4 patients were excluded (3 subjects were not treated as planned, and 1 subject was too heavy.)||units on a scale||Standard Deviation|Mean
823178|NCT01168674|Secondary|Predictors of Bipolarity to Define the Study Population|The specific bipolarity predictors in patients with MDD were assessed.|13 weeks|The most common predictor was antidepressant tolerance, as reported below in 37 subjects.||percentage of subjects|||Number
823179|NCT01168674|Primary|MADRS Improvement Over 6 Weeks|"Montgomery Asberg Depression scale improvement was assessed in two 6 week crossover periods.
Minimum score on MADRS is 0, the maximum is 60. Higher scores represent a worse outcome, i.e., greater severity of depressive symptoms.
Scores of about 20 and above are generally seen as consistent with being in a full major depressive episode.
No subscales were used or combined."|13 weeks (Two 6 week periods plus a one week washout)|||units on a scale||Standard Deviation|Mean
823180|NCT01168687|Primary|Standard Alcoholic Drinks Per Treatment Period|The primary outcome of this study is to determine the effect of levetiracetam on alcohol consumption as measured by change in # of drinks during each treatment period.|This will be assessed during a 42-day period.|All study participants were used for data analysis. If there were no significant differences between the two doses of levetiracetam, data would be collapsed for analysis.||number of drinks per treatment period||Standard Error|Mean
823181|NCT01168726|Secondary|Protective Behavioral Strategies Scale.|Use of protective behavioral strategies related to alcohol use. Higher scores indicate more use of the strategies. A total score was calculated by summing the three subscale scores on the measure (range = 3-18).|6 months|||units on a scale||Standard Deviation|Mean
823182|NCT01168726|Secondary|Drinking Norms Rating Form|Perceived drinking among other students, represented by standardized scores on the Drinking Norms Rating Form. Higher values indicate that the individual perceives higher levels of drinking among other students. Because the scores are standardized their is no hypothetical minimum or maximum, and the scale is standardized with a mean of 0 and standard deviation of 1. So, a mean value of 1.52 means that participants in that condition had an average score that was 1.52 standard deviation above the overall mean of the sample.|6 months|||units on a scale (standardized)||Standard Deviation|Mean
823183|NCT01168726|Primary|Rutgers Alcohol Problems Index (RAPI)|Total scores on an alcohol problems scale. Possible score range = 0-92. Higher scores are indicative of more alcohol-related problems.|6 months|||units on a scale||Standard Deviation|Mean
823184|NCT01168726|Primary|Drinks Per Week||6 Months|||drinks per week||Standard Deviation|Mean
823185|NCT01168856|Primary|Number of Participants Who Had Received Mericitabine (MCB)-Based Regimen and Enrolled in NV22688|Population sequencing was used for determination of loss of resistance status. Results are reported as per donor protocol.|Month 18|Resistance monitoring population.||participants|||Number
823186|NCT01168856|Primary|Number of Participants With STV Resistance Status-Clonal Sequencing|"Clonal sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of STV resistance or without loss of STV resistance.
Category 1-Number of participants with loss of resistance in NV22688. One participant with loss of resistance in NV22688 was included in this analysis.
Category 2-Number of participants with no loss of resistance in NV22688. A total of 4 participants with no loss of resistance in NV22688 were included in this analysis.
Category 3-Number of participants with loss of resistance in donor study. One participant with loss of resistance, analyzed by clonal sequencing in NV22688.
Category 4-Number of participants with loss of resistance in donor study. Two participants with no loss of resistance, analyzed by clonal sequencing in NV22688."|Month 3-18|Resistance monitoring population. Here, n1=total number of participants with loss of STV resistance in NV22688 (by population sequencing). n2= total number of participants who had no STV resistance at the end of donor study they experienced a viral relapse in NV22688.||participants|||Number
823199|NCT01168856|Primary|Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 6|Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.|Month 6|SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 6.||mmHg||Standard Deviation|Mean
824923|NCT01178671|Secondary|Alternative Measure of PTSD Severity|as measured by the Short Posttraumatic Stress Disorder Rating Interview, which rates severity of PTSD from 0 (least severe) to 32 (most severe)|up to 24 weeks|completers||units on a scale||Standard Deviation|Mean
823187|NCT01168856|Primary|Number of Participants With Setrobuvir (STV) Resistance Status-Population Sequencing|"Population sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of STV resistance or without loss of STV resistance.
Category 1-Number of participants with loss of resistance in NV22688. A total of 5 participants with resistance at the end of donor study by population sequencing were included in this analysis.
Category 2-Number of participants with no loss resistance in NV22688. A total of 3 participants with resistance at the end of donor study by population sequencing were included in this analysis.
Category 3-Number of participants with loss of resistance in donor study. A total of 3 participants with no STV resistance at the end of donor study by population sequencing enrolled in NV22688 were included in this analysis."|Month 3-18|Resistance monitoring population.||participants|||Number
823188|NCT01168856|Primary|Number of Participants With BOC or TVR Resistance Status-Clonal Sequencing|"Clonal sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of BOC or TVR resistance or without loss of BOC or TVR resistance.
Category 1-Number of participants with loss of resistance in NV22688. A total of 3 participants with loss of resistance in NV22688 were included in this analysis.
Category 2-Number of participants with no loss of resistance in NV22688. A total of 3 participants with no loss of resistance in NV22688 were included in this analysis.
Category 3-Number of participants with loss of resistance in donor study. A total of 2 participants who had no resistance at the end of donor study were analyzed by clonal sequencing in NV22688."|Month 3-18|Resistance monitoring population.||participants|||Number
823189|NCT01168856|Primary|Number of Participants With Boceprevir (BOC) or Telaprevir (TVR) Resistance Status-Population Sequencing|"Population sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of BOC or TVR resistance or without loss of BOC or TVR resistance.
Category 1-Number of participants with loss of resistance in NV22688. A total of 6 participants with resistance at the end of donor study by population sequencing were included in this analysis.
Category 2-Number of participants with no loss resistance in NV22688. One participant with resistance at the end of donor study by population sequencing was included in this analysis.
Category 3-Number of participants with loss of resistance in donor study. A total of 2 participants with no BOC or TVR resistance at the end of donor study by population sequencing enrolled in NV22688 were included in this analysis."|Month 3-18|Resistance monitoring population.||participants|||Number
823190|NCT01168856|Primary|Number of Participants With DNV Resistance Status-Clonal Sequencing|"Clonal sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of DNV resistance or without loss of DNV resistance.
Category 1-Number of participants with loss of resistance in NV22688. A total of 64 participants with loss of resistance in NV22688 were included in this analysis.
Category 2-Number of participants with no loss of resistance in NV22688. A total of 35 participants with no loss of resistance in NV22688 were included in this analysis.
Category 3-Number of participants with loss of resistance in donor study. A total of 26 participants who had no DNV resistance at the end of donor study were analyzed by clonal sequencing in NV22688. Three participants from donor studies WV21913, NP28266 and NP27946, respectively were not analyzed by clonal sequencing in NV22688 as loss of resistance mutations was demonstrated by clonal sequencing in donor study."|Month 3-18|Resistance monitoring population.||participants|||Number
823191|NCT01168856|Primary|Number of Participants With Danoprevir (DNV) Resistance Status-Population Sequencing|"Population sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of DNV resistance or without loss of DNV resistance.
Results are reported as per donor protocol. Category 1: Number of participants with loss of resistance in NV22688. A total of 99 participants with resistance at the end of donor study by population sequencing were included in this analysis.
Category 2: Number of participants with no loss of resistance in NV22688. A total of 33 participants with resistance at the end of donor study by population sequencing were included in this analysis.
Category 3: Number of participants with loss of resistance in donor study. A total of 30 participants with no DNV resistance at the end of donor study by population sequencing enrolled in NV22688 were included in this analysis."|Month 3-18|Resistance monitoring population.||participants|||Number
823192|NCT01168856|Primary|Mean Pulse Rate in SVR Durability Monitoring Arm at Month 36|Any abnormalities in pulse rate were reported at the discretion of principal investigator.|Month 36|SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 36.||Beats per minute||Standard Deviation|Mean
823193|NCT01168856|Primary|Mean Pulse Rate in SVR Durability Monitoring Arm at Month 24|Any abnormalities in pulse rate were reported at the discretion of principal investigator.|Month 24|SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 24.||Beats per minute||Standard Deviation|Mean
823194|NCT01168856|Primary|Mean Pulse Rate in SVR Durability Monitoring Arm at Month 12|Any abnormalities in pulse rate were reported at the discretion of principal investigator.|Month 12|SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 12.||Beats per minute||Standard Deviation|Mean
823195|NCT01168856|Primary|Mean Pulse Rate in SVR Durability Monitoring Arm at Month 6|Any abnormalities in pulse rate were reported at the discretion of principal investigator.|Month 6|SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 6.||Beats per minute||Standard Deviation|Mean
823196|NCT01168856|Primary|Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 36|Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.|Month 36|SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 36.||mmHg||Standard Deviation|Mean
823197|NCT01168856|Primary|Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 24|Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.|Month 24|SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 24.||mmHg||Standard Deviation|Mean
823198|NCT01168856|Primary|Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 12|Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.|Month 12|SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 12.||mmHg||Standard Deviation|Mean
824924|NCT01178671|Primary|Time to Discontinuation of Study Treatment||up to 24 weeks|||days||Standard Deviation|Mean
823200|NCT01168856|Primary|Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 36|Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.|Month 36|SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 36.||mmHg||Standard Deviation|Mean
823201|NCT01168856|Primary|Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 24|Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.|Month 24|SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 24.||mmHg||Standard Deviation|Mean
823202|NCT01168856|Primary|Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 12|Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.|Month 12|SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 12.||mmHg||Standard Deviation|Mean
823203|NCT01168856|Primary|Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 6|Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.|Month 6|SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 6.||mmHg||Standard Deviation|Mean
823204|NCT01168856|Primary|Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 36|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).|Month 36|SVR durability monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 36.|||||
823205|NCT01168856|Primary|Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 24|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).|Month 24|SVR durability monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 24.|||||
823206|NCT01168856|Primary|Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 12|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).|Month 12|SVR durability monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 12.|||||
823207|NCT01168856|Primary|Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 6|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).|Month 6|SVR durability monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 6.||IU/mL||Standard Deviation|Mean
823208|NCT01168856|Primary|Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 36|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).|Month 36|SVR durability monitoring population included all participants who were enrolled in SVR durability arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 36.||Percentage of participants|||Number
823209|NCT01168856|Primary|Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 24|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).|Month 24|SVR durability monitoring population included all participants who were enrolled in SVR durability arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 24.||Percentage of participants|||Number
823210|NCT01168856|Primary|Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 12|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).|Month 12|SVR durability monitoring population included all participants who were enrolled in SVR durability arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 12.||Percentage of participants|||Number
823211|NCT01168856|Primary|Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 6|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).|Month 6|SVR durability monitoring population included all participants who were enrolled in SVR durability arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 6.||Percentage of participants|||Number
823212|NCT01168856|Primary|Percentage of Participants Who Received Anti-HCV Medications in Resistance Monitoring Arm|Percentage of participants who received any anti-HCV medication during the monitoring period was reported.|Up to 18 months|Resistance monitoring population.||Percentage of participants|||Number
823213|NCT01168856|Primary|Mean Pulse Rate in Resistance Monitoring Arm at Month 18|Any abnormalities in pulse rate were reported at the discretion of principal investigator.|Month 18|Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 18.||Beats per minute||Standard Deviation|Mean
823214|NCT01168856|Primary|Mean Pulse Rate in Resistance Monitoring Arm at Month 12|Any abnormalities in pulse rate were reported at the discretion of principal investigator.|Month 12|Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 12.||Beats per minute||Standard Deviation|Mean
823215|NCT01168856|Primary|Mean Pulse Rate in Resistance Monitoring Arm at Month 9|Any abnormalities in pulse rate were reported at the discretion of principal investigator.|Month 9|Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 9.||Beats per minute||Standard Deviation|Mean
823216|NCT01168856|Primary|Mean Pulse Rate in Resistance Monitoring Arm at Month 6|Any abnormalities in pulse rate were reported at the discretion of principal investigator.|Month 6|Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 6.||Beats per minute||Standard Deviation|Mean
823217|NCT01168856|Primary|Mean Pulse Rate in Resistance Monitoring Arm at Month 3|Any abnormalities in pulse rate were reported at the discretion of principal investigator.|Month 3|Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 3.||Beats per minute||Standard Deviation|Mean
823218|NCT01168856|Primary|Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 18|Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.|Month 18|Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 18.||mmHg||Standard Deviation|Mean
823219|NCT01168856|Primary|Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 12|Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.|Month 12|Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 12.||mmHg||Standard Deviation|Mean
823220|NCT01168856|Primary|Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 9|Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.|Month 9|Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 9.||mmHg||Standard Deviation|Mean
823221|NCT01168856|Primary|Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 6|Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.|Month 6|Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 6.||mmHg||Standard Deviation|Mean
823222|NCT01168856|Primary|Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 3|Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.|Month 3|Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 3.||mmHg||Standard Deviation|Mean
823223|NCT01168856|Primary|Mean Systolic Blood Pressure in Resistance Monitoring Arm at Month 18|Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.|Month 18|Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 18.||mmHg||Standard Deviation|Mean
823224|NCT01168856|Primary|Mean Systolic Blood Pressure in Resistance Monitoring Arm at Month 12|Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.|Month 12|Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 12.||mmHg||Standard Deviation|Mean
823225|NCT01168856|Primary|Systolic Blood Pressure in Resistance Monitoring Arm at Month 9|Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.|Month 9|Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 9.||mmHg||Standard Deviation|Mean
823226|NCT01168856|Primary|Systolic Blood Pressure in Resistance Monitoring Arm at Month 6|Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.|Month 6|Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 6.||mmHg||Standard Deviation|Mean
823227|NCT01168856|Primary|Mean Systolic Blood Pressure in Resistance Monitoring Arm at Month 3|Any abnormalities in systolic blood pressure (units: millimeters of Mercury [Hg] [mmHg]) were reported at the discretion of principal investigator.|Month 3|Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 3.||mmHg||Standard Deviation|Mean
823228|NCT01168856|Primary|HCV RNA Levels in Resistance Monitoring Arm at Month 18|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).|Month 18|Resistance monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 18.||IU/mL||Standard Deviation|Mean
823229|NCT01168856|Primary|HCV RNA Levels in Resistance Monitoring Arm at Month 12|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).|Month 12|Resistance monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 12.||IU/mL||Standard Deviation|Mean
823230|NCT01168856|Primary|HCV RNA Levels in Resistance Monitoring Arm at Month 9|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).|Month 9|Resistance monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 9.||IU/mL||Standard Deviation|Mean
823231|NCT01168856|Primary|HCV RNA Levels in Resistance Monitoring Arm at Month 6|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).|Month 6|Resistance monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 6.||IU/mL||Standard Deviation|Mean
823232|NCT01168856|Primary|HCV RNA Levels in Resistance Monitoring Arm at Month 3|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).|Month 3|Resistance monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 3.||IU/mL||Standard Deviation|Mean
823233|NCT01168856|Primary|Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 18|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).|Month 18|Resistance monitoring population included all participants who were enrolled in resistance monitoring arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 18.||Percentage of participants|||Number
823234|NCT01168856|Primary|Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 12|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).|Month 12|Resistance monitoring population included all participants who were enrolled in resistance monitoring arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 12.||Percentage of participants|||Number
823235|NCT01168856|Primary|Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 9|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).|Month 9|Resistance monitoring population included all participants who were enrolled in resistance monitoring arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 9.||Percentage of participants|||Number
823236|NCT01168856|Primary|Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 6|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).|Month 6|Resistance monitoring population included all participants who were enrolled in resistance monitoring arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 6.||Percentage of participants|||Number
823267|NCT01170598|Primary|Program Adherence.|Adherence to supervised exercise program assessed as a percentage of exercise sessions completed(number of days of supervised exercise performed/the number of days that patients were approached to participate).|Baseline, Post-induction (weeks 4-6)|||percentage of exercise days completed|||Number
823237|NCT01168856|Primary|Percentage of Participants With the Detectable HCV Ribonucleic Acid (RNA) Results in Resistance Monitoring Arm at Month 3|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 International Units per milliliter [IU/mL]).|Month 3|Resistance monitoring population included all participants who were enrolled in resistance monitoring arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 3.||Percentage of participants|||Number
823238|NCT01168934|Secondary|Metabolite to Parent Ratio Maximum Observed Plasma Concentration (MRCmax)|Metabolite to parent molar ratio of maximum observed plasma concentration (MRCmax).|0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A and 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||Ratio||Standard Deviation|Geometric Mean
823239|NCT01168934|Secondary|Metabolite to Parent Ratio Area Under the Curve From Time Zero to Extrapolated Infinite Time (MRAUC [0-∞])|Molar ratio of metabolite to parent area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞) (MRAUC [0-∞]).|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Here, the ‘N = 13’ is signifying those participants who were evaluable for this measure at the specified time point for this arm group.||Ratio||Standard Deviation|Geometric Mean
823240|NCT01168934|Secondary|Metabolite to Parent Ratio of Area Under the Curve From Time Zero to Last Quantifiable Concentration for Crizotinib Metabolite Ratio (MRAUClast)|Molar ratio of metabolite to parent area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (MRAUClast).|0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A and 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||Ratio||Standard Deviation|Geometric Mean
823241|NCT01168934|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) for Crizotinib Metabolite (PF-06260182)||0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||hr||Full Range|Median
823242|NCT01168934|Secondary|Maximum Observed Plasma Concentration (Cmax) for Crizotinib Metabolite (PF-06260182)||0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A and 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng/mL||Standard Deviation|Geometric Mean
823243|NCT01168934|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞]) for Crizotinib Metabolite (PF-06260182)|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞) of crizotinib metabolite (PF-06260182).|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Here, the ‘N = 13’ is signifying those participants who were evaluable for this measure at the specified time point for this arm group.||ng*hr/mL||Standard Deviation|Geometric Mean
823244|NCT01168934|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Crizotinib Metabolite (PF-06260182)|Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast) of crizotinib metabolite (PF-06260182).|0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A and 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng*hr/mL||Standard Deviation|Geometric Mean
823245|NCT01168934|Secondary|Volume of Distribution at Steady State (Vss)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.|0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||L||Standard Deviation|Geometric Mean
823246|NCT01168934|Secondary|Apparent Volume of Distribution (Vz/F)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||L||Standard Deviation|Geometric Mean
823247|NCT01168934|Secondary|Systemic Clearance (CL)|CL is a quantitative measure of the rate at which a drug substance is removed from the body.|0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||L/hr||Standard Deviation|Geometric Mean
823262|NCT01170533|Primary|Platelet Function as Assessed by the P2Y12 Reactivity Index|P2Y12 reactivity index which will be assessed by flow cytometry determination of vasodilator-stimulated phosphoprotein (VASP).|1 week|A sample size of 18 patients was required to be able to detect a 10% absolute difference in PRI between both regimens with 80% power and 2-sided significance level of 0.05, assuming a 15% standard deviation for the difference between regimens.||Percentage of platelet reactivity index||Standard Error|Least Squares Mean
823248|NCT01168934|Secondary|Apparent Oral Clearance (CL/F)|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||L/hr||Standard Deviation|Geometric Mean
823249|NCT01168934|Secondary|Plasma Decay Half Life (t1/2)|Plasma decay half life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A and 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||hr||Standard Deviation|Mean
823250|NCT01168934|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||hr||Full Range|Median
823251|NCT01168934|Secondary|Maximum Observed Plasma Concentration (Cmax)||0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A and 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng/mL||Standard Deviation|Geometric Mean
823252|NCT01168934|Secondary|Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast[dn])|AUClast[dn] = Dose normalized area under the plasma concentration time-curve (AUC[dn]) from zero to the last measured concentration.|0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A and 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B|PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng*hr/mL/mg||Standard Deviation|Geometric Mean
823253|NCT01168934|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast).|0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A and 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng*hr/mL||Standard Deviation|Geometric Mean
823254|NCT01168934|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞])|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A and 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng*hr/mL||Standard Deviation|Geometric Mean
823255|NCT01168934|Primary|Dose Normalized Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞][dn])|AUC [0 - ∞][dn] = Dose normalized area under the plasma concentration versus time curve (AUC[dn]) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - ∞) divided by dose.|0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hours (hrs) post IV crizotinib dose in Treatment A and 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B|Pharmacokinetic (PK) parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng*hr/mL/mg||Standard Deviation|Geometric Mean
823256|NCT01170364|Primary|24 Hour Measured Caloric Intake|The primary outcome measure is 24-hour food intake assessed by 24 hour weighed intake after one week of sibutramine administration compared to one week of placebo administration.|1 week|This is a cross over design study. All participants received sibutramine and placebo. The sibutramine arm listed here includes all participants who received sibutramine (regardless of whether they received it first or second). The placebo arm included all those who received placebo (regardless of whether they received it first or second).||kcal||Standard Deviation|Mean
823257|NCT01170390|Secondary|EE Steady State After Randomization|Steady state levels of ethinyl estradiol (EE) post- randomization|Post-randomiziation 4 months|||ng/mL||Standard Deviation|Mean
823258|NCT01170390|Secondary|EE Steady State Baseline|Steady state levels of ethinyl estradiol (EE) at baseline (2 months)|Baseline (2 months)|One subject discontinued prior to the completion of the baseline cycle in the Aviane/Aviane arm||ng/mL||Standard Deviation|Mean
823259|NCT01170390|Secondary|LNG AUC|Baseline measurements of levonorgestrel AUC (on Aviane). Area under the curve at baseline for levonorgestrel. AUC was calculated from time zero to 168 hours and extrapolated to infinity from serial repeat sampling (0,0.5,1.1.5,2,3,4,6,8,12 hours and then single samples daily for 4 days between Cycles 1 and 2.|baseline (2 months)|||hr*ng/mL||Standard Deviation|Mean
823260|NCT01170390|Secondary|LNG AUC|Area under the curve post-randomization for levonorgestrel. AUC was calculated and extrapolated using post randomization in single daily samples drawn during Cycle 4 days 20-26. Serial repeat sampling to obtain a detailed PK curve was not performed to obtain this AUC. Subjects could provide samples during these days at times convenient to them and PK software accounted for the time between when the drug was dosed versus when the sample was drawn.|post-randomization (4 months)|||hr*ng/mL||Standard Deviation|Mean
823261|NCT01170390|Primary|LNG Steady State at Baseline and Then Post-randomization|The main goal is to test whether key pharmacokinetic parameters of levonordestrel (LNG) differ between obese women taking traditionally dosed OCs versus the interventional arms (i.e. using each obese subject as their own control).|baseline (2 months) and post-randomization (4 months)|One subject discontinued prior to the completion of the baseline studies in the Aviane/Aviane arm||ng/mL||Standard Deviation|Mean
823269|NCT01170598|Primary|Recruitment Rate|Ratio of patients who consented to participate out of all eligible patients expressed as a percentage (eligible patients who consented to participation/eligible patients who declined participation).|Baseline|For this outcome measure we analyzed 52 participants (rather than 35). Fifty-two participants met the study eligibility criteria. Thirty-five out of 52 consented to participate which is how we derived our recruitment rate of 67% (35/52).||percentage of patients|||Number
823270|NCT01170598|Secondary|Development of Sepsis|Development of sepsis (percentage of participants who developed sepsis during induction chemotherapy course).|Post-induction (weeks 4-6)|||percentage of participants|||Number
823271|NCT01170598|Secondary|Intensive Care Unit (ICU) Admission|Intensive care unit (ICU) admission (percentage of participants admitted to ICU during induction chemotherapy course).|Post-induction (weeks 4-6)|||percentage of participants|||Number
823272|NCT01170598|Secondary|Length of Stay|Length of stay (date of admission to hospital to date of discharge).|Post-induction (weeks 4-6)|||days||Standard Deviation|Mean
823273|NCT01170598|Secondary|Fatigue|Fatigue will be assessed using the Functional Assessment of Cancer Therapy fatigue subscale (FACT-Fatigue). The FACT-Fatigue consists of 13 questions and has excellent psychometric characteristics. Fatigue scores derived from this questionnaire range from 0-52 with a higher score reflecting lower fatigue.|Baseline, Post-induction (weeks 4-6)|||units on a scale||Standard Deviation|Mean
823274|NCT01170598|Secondary|Global Quality of Life|Global quality of life (QOL) will be measured by the European Organization for the Research and Treatment of Cancer (EORTC) core 30-item questionnaire (QLQ-C30). The EORTC QLQ-C30 is a widely used, self-reported, psychometrically sound cancer QOL instrument. QOL scores derived from this questionnaire range from 0-100 with a higher score reflecting a higher QOL.|Baseline, Post-induction (weeks 4-6)|||units on a scale||Standard Deviation|Mean
823275|NCT01170598|Primary|Grip Strength|Measure of upper-body strength using a Jamar hand dynamometer. Participants were asked to hold and squeeze (the dynamometer) with maximal force. Three trials were completed with each hand, alternating between the right and left to minimize fatigue. The highest recorded value of the dominant hand was used in the analysis.|Baseline, Post-induction (weeks 4-6)|||kilograms||Standard Deviation|Mean
823276|NCT01170598|Primary|Timed 10-chair Stands|Measure of lower-body strength completed by standing from a seated position 10 times as quickly as possible.|Baseline, Post-induction (weeks 4-6)|||seconds||Standard Deviation|Mean
823277|NCT01170598|Primary|6-minute Walk Test|Measure of functional endurance assessed by the walking distance covered in a 6-minute period. Participants walk a pre-established course for a total of 6 minutes. The distance covered in that time is recorded as the 6-minute walk test score.|Baseline, Post-induction (4-6 weeks)|||feet||Standard Deviation|Mean
823278|NCT01170598|Primary|Peak Aerobic Capacity (VO2peak)|The modified Bruce protocol is a walking-based treadmill test used to assess peak aerobic capacity. As the test progresses the intensity of each 3-minute work load increases. The test concludes when the participant reaches his maximal heart rate or volitional fatigue. The value attained on this test is measured in metabolic equivalents (METS). METS are a measure of exercise intensity and reflect the physical demands of an activity. In this context, a higher value achieved on the treadmill test (in METS) indicates work at a higher intensity and therefore a higher aerobic capacity.|Baseline, Post-induction (weeks 4-6)|||metabolic equivalent (METS)||Standard Deviation|Mean
823279|NCT01170663|Other Pre-specified|Number of Participants With Serious and Other Non-serious Adverse Events (AE) and Who Died|Participants who died or who had clinically significant events defined as serious AEs (SAEs) and other non-serious AEs (regardless of causality). A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.|Baseline up to 103 weeks and within 30 days of last dose of study drug|All randomized participants who received at least 1 dose of study drug and based on the treatment each participant received.||participants|||Number
823280|NCT01170663|Secondary|Change From Baseline to End of Therapy in European Quality of Life Questionnaire-5 Dimension (EuroQol EQ-5D) Index Score|The EQ-5D is a generic, multidimensional, health status instrument. The profile allowed participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a 3-level scale [1 (no problem), 2 (some problems), and 3 (major problems)]. These combinations of responses were converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension). A negative change indicated a worsening of the participant's health status.|Baseline, end of therapy (up to 103 weeks)|All participants according to the treatment group to which they were randomized with baseline and end of treatment EQ-5D observations.||units on a scale||Standard Deviation|Mean
823281|NCT01170663|Secondary|Change From Baseline to End of Therapy in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life: Questionnaire (QLQ-C30) in Global Health Status|EORTC QLQ-C30 v3.0 is a 30-item, self-administered questionnaire with multidimensional scales assessing 15 domains (5 functional domains [physical, role, cognitive, emotional, and social], 9 symptom scales [fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties] and global health status scale). 28 questions assessed on a 1 (not at all) to 4 (very much) scale and the remaining 2 questions used a 1 (poor) to 7 (excellent) scale. A linear transformation was applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For the functional domains and global health status scale, higher scores represent a better level of functioning. For symptoms scales, higher scores represented a greater degree of symptoms.|Baseline, end of therapy (up to 103 weeks)|All participants according to the treatment group to which they were randomized with baseline and end of treatment Global Health Status observations.||units on a scale||Standard Deviation|Mean
823282|NCT01170663|Secondary|Cmin Prior to 7th Ramucirumab (IMC-1211B) Infusion||Cycle 4, Day 1 (28-day cycles)|All participants who received Ramucirumab (IMC-1121B) plus Paclitaxel and had Cmin observations at specific timepoint.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
823283|NCT01170663|Secondary|Cmin Prior to 4th Ramucirumab (IMC-1211B) Infusion||Cycle 2, Day 15 (28-day cycle)|All participants who received Ramucirumab (IMC-1121B) plus Paclitaxel and had Cmin observations at specific timepoint.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
823284|NCT01170663|Secondary|Minimum Concentration (Cmin) Prior to First Ramucirumab (IMC-1211B) Infusion|This outcome measure was included in error as the time point was before ramucirumab (IMC-1211B) was administered. Cmin was not analyzed.|Cycle 1, Day 1 predose (28-day cycles)|Zero participants were analyzed.|||||
823287|NCT01170663|Secondary|Maximum Concentration (Cmax) After First Ramucirumab (IMC-1211B) Infusion||Cycle 1, Day 1, 1 hour post end of infusion (28-day cycles)|All participants who received Ramucirumab (IMC-1121B) plus Paclitaxel and had Cmax observations at specific timepoint.||micrograms/milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
823288|NCT01170663|Secondary|Percentage of Participants With Anti-Ramucirumab Antibodies (Serum Anti-Ramucirumab Antibody Assessment )(Immunogenicity)|Participants who developed treatment-emergent antibody responses to Ramucirumab (IMC-1121B) after baseline.|Prior to and after ramucirumab (IMC-1121B) infusion: Day 1 Cycles 1, 2 and 3 (28-day cycles) Doses 1, 4, 7 and 30-37 days after last dose of study therapy up to 103 weeks|All participants according to the treatment group to which they were randomized and received at least 1 dose of study drug with anti-ramucirumab antibodies.||percentage of participants|||Number
823289|NCT01170663|Secondary|Percentage of Participants With CR or PR [Objective Response Rate (ORR)]|ORR was the percentage of participants who had CR or PR defined using RECIST v1.1 criteria. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm and normalization of tumor marker level of non-target lesions. PR was defined as having a ≥30% decrease in sum of LD of target lesions. Percentage of participants calculated as: (number of participants with CR + PR)/(total number of participants)*100.|Randomization up to 22.2 months|All participants according to the treatment group to which they were randomized.||percentage of participants||95% Confidence Interval|Number
823290|NCT01170663|Secondary|Best Overall Response (BOR) of Complete Response (CR), Partial Response (PR), Stable Disease (SD) or PD|BOR was defined as the best response across all time points from randomization until radiologically confirmed PD using RECIST, v1.1 criteria. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm and normalization of tumor marker level of non-target lesions. PR was defined as having a ≥30% decrease in sum of LD of target lesions. PD was defined as having a ≥20% increase in sum of LD of target lesions and ≥5 mm increase above nadir. SD was defined as small changes that did not meet above criteria.|Randomization up to 22.2 months|All participants according to the treatment group to which they were randomized.||percentage of participants|||Number
823291|NCT01170663|Secondary|Time to Progressive Disease (TTP)|TTP was defined as the time from randomization until date of radiographic progression using RECIST v1.1 criteria. PD was defined as having a ≥20% increase in sum of longest diameter (LD) of target lesions and at minimum 5 millimeters (mm) increase above nadir. Participants who did not progress or were lost to follow-up were censored at the date of last tumor assessment. Participants who had no baseline tumor assessment or no post baseline assessment and no death reported with 2 scan intervals post randomization were censored at date of randomization. Participants with no progression and not died within 2 scan intervals after last assessment were censored at date of last tumor assessment. Participants with no post baseline assessment or tumor progression but death reported within 2 scan intervals after randomization were censored at date of death.|Baseline up to 22.2 months|All participants according to the treatment group to which they were randomized. Participants censored: Ramucirumab (IMC-1211B) plus Paclitaxel =107, Placebo plus Paclitaxel =94.||months||95% Confidence Interval|Median
823292|NCT01170663|Secondary|Progression-Free Survival (PFS)|PFS was measured from date of randomization to first radiographically documented progressive disease (PD) or death due to any cause. PD defined using Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of at least 5 mm. Participants who had no baseline or post baseline radiological tumor assessment were censored at date of randomization. Participants who had no tumor progression or death within 2 scan intervals following the last assessment were censored at the date of last radiographic tumor assessment. Participants who began new anticancer treatment and had no tumor progression were censored at date of assessment prior to initiation of new therapy. Participants lost to follow-up or withdrew consent were censored at the date of their last assessment.|Randomization up to 22.2 months|All participants according to the treatment group to which they were randomized. Participants censored: Ramucirumab (IMC-1211B) plus Paclitaxel =51, Placebo plus Paclitaxel =39.||months||95% Confidence Interval|Median
823293|NCT01170663|Primary|Overall Survival Time (OS)|OS time was measured from date of randomization to date of death from any cause. Participants who were not known to have died on or before the date of data cut-off, OS data was censored on the last date (on or before the cut-off date) the participant was known to be alive.|Randomization up to 27.5 months|All participants according to the treatment group to which they were randomized. Participants censored: Ramucirumab (IMC-1211B) plus Paclitaxel =74, Placebo plus Paclitaxel =75.||months||95% Confidence Interval|Median
823294|NCT01170754|Other Pre-specified|Boston Prep Scale (Per Protocol Analysis)|"Analysis includes a sub-group of subjects who drank >75% of the preparation and adhered to a clear liquid diet (Per Protocol).
The BPS is scored 0-9 with 9 being an excellent preparation throughout the colon. From the right colon, transverse colon , and left colon a score of 0-3 is given as follows and the total BPS is the arithmetic sum from each colon segment:"|photographs were taken throughout colonoscopy and reviewed within 1 month after procedure|Includes subjects who followed instructions (Per Protocol analysis)||units on a scale||Standard Deviation|Mean
823295|NCT01170754|Secondary|Phosphorus Level in mg/dl|Phosphorus level: Risks from the preparation include failure to cleanse the colon adequately and the risk of electrolyte abnormalities, particularly hypokalemia. We will compare adverse events from the comparator preps by assessing electrolytes on the day of the procedure.|Day of procedure|||mg/dl||Standard Deviation|Mean
823296|NCT01170754|Secondary|Magnesium Level in mg/dl|Magnesium level: Risks from the preparation include failure to cleanse the colon adequately and the risk of electrolyte abnormalities, particularly hypokalemia. We will compare adverse events from the comparator preps by assessing electrolytes on the day of the procedure.|Day of procedure|||mg/dl||Standard Deviation|Mean
823297|NCT01170754|Secondary|Calcium Level in mg/dl|Calcium level: Risks from the preparation include failure to cleanse the colon adequately and the risk of electrolyte abnormalities, particularly hypokalemia. We will compare adverse events from the comparator preps by assessing electrolytes on the day of the procedure.|Day of procedure|||mg/dl||Standard Deviation|Mean
823298|NCT01170754|Secondary|Glucose Level in mg/dl|Glucose level: Risks from the preparation include failure to cleanse the colon adequately and the risk of electrolyte abnormalities, particularly hypokalemia. We will compare adverse events from the comparator preps by assessing electrolytes on the day of the procedure.|Day of procedure|||mg/dl||Standard Deviation|Mean
823299|NCT01170754|Secondary|Creatinine Level in mg/dl|Creatinine level: Risks from the preparation include failure to cleanse the colon adequately and the risk of electrolyte abnormalities, particularly hypokalemia. We will compare adverse events from the comparator preps by assessing electrolytes on the day of the procedure.|Day of procedure|||mg/dl||Standard Deviation|Mean
823300|NCT01170754|Secondary|BUN Level in mg/dl|BUN level: Risks from the preparation include failure to cleanse the colon adequately and the risk of electrolyte abnormalities, particularly hypokalemia. We will compare adverse events from the comparator preps by assessing electrolytes on the day of the procedure.|Day of procedure|||mg/dl||Standard Deviation|Mean
823301|NCT01170754|Secondary|Bicarbonate Level in mmol/L|Bicarbonate level: Risks from the preparation include failure to cleanse the colon adequately and the risk of electrolyte abnormalities, particularly hypokalemia. We will compare adverse events from the comparator preps by assessing electrolytes on the day of the procedure.|Day of procedure|||mmol/L||Standard Deviation|Mean
823302|NCT01170754|Secondary|Chloride Level in mmol/L|Chloride level: Risks from the preparation include failure to cleanse the colon adequately and the risk of electrolyte abnormalities, particularly hypokalemia. We will compare adverse events from the comparator preps by assessing electrolytes on the day of the procedure.|Day of procedure|||mmol/L||Standard Deviation|Mean
823303|NCT01170754|Secondary|Potassium Level in mmol/L|Potassium level: Risks from the preparation include failure to cleanse the colon adequately and the risk of electrolyte abnormalities, particularly hypokalemia. We will compare adverse events from the comparator preps by assessing electrolytes on the day of the procedure.|Day of procedure|||mmol/L||Standard Deviation|Mean
823304|NCT01170754|Secondary|Sodium Level in mmol/L|Sodium level: Risks from the preparation include failure to cleanse the colon adequately and the risk of electrolyte abnormalities, particularly hypokalemia. We will compare adverse events from the comparator preps by assessing electrolytes on the day of the procedure.|Day of procedure|||mmol/L||Standard Deviation|Mean
823305|NCT01170754|Primary|Boston Prep Scale|"The study is a non-inferiority study: The objective is to conclude that the prep quality scores of those receiving Miralax is at most 10% less than for Golytely. Thus the difference in prep scores between Miralax minus Golytely should be greater than - 10%. If this is the case, Miralax would be considered as non-inferior to Golytely.
The outcome measure will use the Boston Prep Scale. The BPS is scored 0-9 with 9 being an excellent preparation throughout the colon. From the right colon, transverse colon , and left colon a score of 0-3 is given as follows and the total BPS is the arithmetic sum from each colon segment:
0 = Unprepared colon segment with mucosa not seen due to solid stool.
= Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen.
= Minor amount of residual staining, small fragments of stool and/or opaque liquid
= clear colon without staining"|photographs were taken throughout the colonoscopy and reviewed within 1 month after procedure.|Includes all subjects who were enrolled and underwent procedure (Intention-to-treat analysis)||units on a scale||Standard Deviation|Mean
823306|NCT01170884|Primary|Mean Diurnal Intraocular Pressure (IOP) at Week 12|Mean Diurnal (average of 8 AM, 10 AM, and 4 PM time points) IOP at Week 12 in the study eye. IOP is a measurement of the fluid pressure inside the eye.|Week 12|Intent-to-Treat (ITT) included all subjects who were randomized to study medication.||Millimeters of mercury (mm Hg)||Standard Deviation|Mean
823307|NCT01170949|Primary|Urticaria Activity Score (% Change From Baseline)|The weekly UAS was calculated by adding the daily scores over one week. During the whole course of the study patients recorded the amount of wheals and the intensity of itching as well as the occurrence of swelling in ranges between 0 and 3. These daily scores were used to calculate urticaria activity scores (UAS) as follows: Daily UAS are calculated by adding the score points obtained for the symptom categories “number of wheals” and “intensity of pruritus”. “Number of wheals” is scored as 0 = no wheals, 1 = some wheals (<20), 2 = moderate number of wheals (20-50), 3 = more than 50 wheals. “Intensity of pruritus” is scored as 0 = no itching; 1 = mild itching, not irritating; 2 = moderate itching, normal daily activity and sleep is possible; and 3 = severe itching, normal daily activity and sleep is impaired. The maximum score is 42.|Day 28|ITT = 73||percentage of UAS baseline||Standard Deviation|Mean
823308|NCT01170962|Primary|Number of Participants With Serious Adverse Events (SAEs) and Who Died During Follow-up Period|AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.|From day 8 post last dose of treatment up-to Week 72|Safety population included all treated participants.||participants|||Number
823309|NCT01170962|Secondary|Number of Participants With Genotypic-1B Substitution at Baseline, On-treatment and During Follow-up Associated With Virologic Failures|Non-structural protein 5A of HCV resistance associated polymorphisms in GT-1b samples, included L28M/V, R30H/Q, L31M, Q54H/N/Y, P58A/Q/S, Q62E/K/N/R/S, A92T/V and Y93F/H.|Baseline to follow-up Week 48|All treated participants who received at least 1 dose of study therapy.||participants|||Number
823310|NCT01170962|Secondary|Number of Participants With Genotypic-1A Substitution at Baseline, On-treatment and During Follow-up Associated With Virologic Failures|Non-structural protein 5A of HCV resistance associated polymorphism in GT-1a samples included M28L/T/V, Q30H, L31M, H54Y, H58C/D/N/P/Q, E62D and Y93C.|Baseline to follow-up Week 48|All treated participants who received at least 1 dose of study therapy.||participants|||Number
823311|NCT01170962|Secondary|Percentage of Participants With Sustained Virologic Response at Week 12 (SVR12)|SVR12 was defined as undetectable RNA ie., Hepatitis C virus (HCV) RNA <lower limit of quantitation (LLOQ), target not detected (TND) at follow-up Week 12. TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Follow-up Week 12|All treated participants who received at least 1 dose of study therapy.||percentage of participants||80% Confidence Interval|Number
824925|NCT01178671|Primary|PTSD Severity|PTSD severity will be measured by the Clinician-Administered Posttraumatic Stress Disorder Scale, from 0 (least severe) to 136 (most severe).|up to 24 weeks|intention to treat sample||units on a scale||Standard Deviation|Mean
823312|NCT01170962|Secondary|Percentage of Participants With Complete Early Virologic Response (cEVR)|cEVR was defined as undetectable RNA ie., Hepatitis C virus (HCV) RNA <lower limit of quantitation [LLOQ], target not detected (TND) at Week 12. TND was 10 IU/mL. HCV RNA levels were measured by the Roche Cobas® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 12|All treated participants who received at least 1 dose of study therapy.||percentage of participants||80% Confidence Interval|Number
823313|NCT01170962|Secondary|Percentage of Participants With Rapid Virologic Response (RVR)|RVR was defined as undetectable RNA ie., Hepatitis C virus (HCV) RNA <lower limit of quantitation [LLOQ], target not detected (TND) at Week 4. TND was 10 IU/mL. HCV RNA levels were measured by the Roche Cobas® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 4|All treated participants who received at least 1 dose of study therapy.||percentage of participants||80% Confidence Interval|Number
823314|NCT01170962|Primary|Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs) and Who Died On-treatment|AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity; or was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.|From first dose to last dose plus 7 days, up to 49 weeks|Safety population included all treated participants.||participants|||Number
823315|NCT01170962|Primary|Percentage of Participants With 24-week Sustained Virologic Response (SVR24)|SVR24 was defined as undetectable RNA (Hepatitis C Virus [HCV] RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at follow-up Week 24. TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Follow-up Week 24|All treated participants who received at least 1 dose of study therapy.||percentage of participants||80% Confidence Interval|Number
823316|NCT01170962|Primary|Percentage of Participants With Extended Rapid Virologic Response (eRVR)|eRVR was defined as undetectable Hepatitis C virus RNA at both Weeks 4 and 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 4, Week 12|All treated participants who received at least 1 dose of study therapy.||percentage of participants||80% Confidence Interval|Number
823317|NCT01171118|Primary|AHI - Apnea Hypopnea Index|This is a standard metric used to describe severity of disordered breathing during sleep.Normal healthy subjects would have an AHI value of zero during sleep. Mild disordered breathing would correspond to a value of 5 to 10 events per hours; moderate 10-25; severe would be over 25|2- 2 1/2 hours during study visit|This is a standard size for this type of sleep study and was performed per protocol.||events per hour||Standard Deviation|Mean
823318|NCT01171183|Secondary|Retention|number of weeks each participant is on study protocol|12 weeks|Those eligible participants who entered the residential facility and received at least one dose of study medication. One person in the carvedilol group is excluded from all analyses due to not meeting inclusion criteria.||Weeks||Standard Deviation|Mean
823319|NCT01171183|Primary|Urine Toxicology Screens|Treatment Effectiveness Score, defined by the # of cocaine negative urines during the outpatient phase of the study divided by the total number of urine samples (30) and then multiplied by 100.|based on thrice weekly urine results during the 10-week outpatient phase|Those who completed the residential facility and attended at least one outpatient clinic visit to complete assessments.||percentage of cocaine negative urines||Standard Deviation|Mean
823320|NCT01171521|Secondary|Pain|Visual Analog Pain Scale (VAS) with DermaClose use, and on study wound at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months. The scale goes from 0 to 10 with 0 being no pain and 10 being the most severe pain imaginable. It is a visual analog scale so is continuous data.|6 months|||units on a scale||Standard Deviation|Mean
823321|NCT01171521|Primary|Quality of Life|"The SF-12 contains 12 items from the SF-36 Health Survey - . The SF-12 contains one or two items that measure each of the eight concepts included in the SF-36.
The Quality of Life SF-12 is a scale from 0 - 100, in which 0 = poor functioning and 100 = excellent functioning."|6 months|||units on a scale||Standard Deviation|Mean
823322|NCT01171534|Secondary|Cost-to-Benefit Ratio of DermaClose Versus Vessel Loop Fasciotomy Closure|Costs associated with both types of closure (DermaClose and Vessel Loop) including hospital days, number of procedures, procedural and hospital costs including device(s), negative pressure wound therapy costs, and operating room time and associated costs.|One year||||||
823323|NCT01171534|Secondary|Quality of Life|Quality of Life measured by the SF-12 version 1 at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months|One Year||||||
823324|NCT01171534|Secondary|Pain|Visual Analog Pain Scale (VAS) during initial hospitalization and at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months|One Year|too low of an enrollment volume to analyze|||||
823325|NCT01171534|Primary|Performance of DermaClose System in Treatment of Fasciotomy Wounds|Days to wound closure; number and types of procedures required for wound closure; infection requiring reoperation; wound dehiscence requiring reoperation|One year|Too low of an enrollment volume to analyze|||||
823326|NCT01171612|Secondary|Number of Patients With Adverse Events Related With Antiplatelet Therapy Management|"Perioperative withdrawal antiplatelet therapy is defined with > or = 5 days without therapy
We create 3 categories:
Not withdrawal
Complete withdrawal (5 or > days without antiplatelet drugs , mono or dual therapy)
Incomplete withdrawal: patients under dual antiplatelet therapy, who maintain aspirin and stopped clopidogrel =/ > 5 days"|90 days after surgery|MACCEs||participants|||Number
823327|NCT01171612|Secondary|Major Haemorrhagic Events|Transfusion > = 2 red blood cells Units, haemoglobin descent >= 20 gr/dL, intracerebral haemorrhage|up to 90 days after surgery|||participants|||Number
823328|NCT01171612|Primary|Major Adverse Cardiac and Cerebrovascular Events (MACCEs)|Cardiac Mortality, Myocardial Infarction, Angina Pectoris, new arrythmia, Congestive Heart Failure, Stroke, Cardiac Arrest|up to 90 days after surgery|||participants|||Number
823329|NCT01171677|Primary|Roesenberg Self Esteem|The Rosenberg Self-Esteem Scale is a 10-item, 4-point Likert scale used to assess global self-esteem. The scale ranges from 0-30 with higher scores indicating higher the self-esteem.|Baseline to end of intervention (week 14)|participants completing each arm||units on a scale||Standard Deviation|Mean
823466|NCT01172600|Secondary|Biomarkers|BIOMARKERS: IL-1β, IL-6, IL-10, 1L-17A, IFN-γ, and TNF-α|before 3rd block, typically at 2 months from baseline|21 Entonox patients and 26 Oxygen patients did come for the 3rd block. Among the patients who came for the 3rd block, blood sample was not collected in 5 Entonox patients and 1 Oxygen patient.||pg/ml||Inter-Quartile Range|Median
823330|NCT01171677|Primary|Quality of Life (QoL)|The Quality of Life (QoL) assessment is adapted from Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q). The 23-item QoL consists of five subscales: physical health/activities, feelings, leisure time activities, social relations, and general activities. The scale ranges from 23-115; the higher score indicates higher quality of life enjoyment and satisfaction.|Baseline to end of intervention (week 14)|participants completing intervention||units on a scale||Standard Deviation|Mean
823331|NCT01171677|Primary|Self-Efficacy for Abstinence|The Self-Efficacy for Abstinence assessment is adapted from DiClemente (1994)’s Alcohol Abstinence Self-Efficacy. The modified 10-item, 5-point Likert scale (Not at all to Extremely) assesses confidence in abstaining from alcohol. The scale is comprised of four subscales: negative affect, social/positive, physical and other concerns, and withdrawal and urges. Overall abstinence self-efficacy score is calculated by summing each item. The scale ranges from 10-50, the higher the score the higher the self-efficacy for abstinence.|Baseline to end of intervention (week 14)|participants completing each arm||units on a scale||Standard Deviation|Mean
823332|NCT01171677|Primary|Wechsler Test of Adult Reading (WTAR)|Wechsler Test of Adult Reading (WTAR) measures reading ability. The test involves 50 incorrectly spelled words. The score is computed based on the number of correctly pronounced words. The scale ranges from 0-50, the higher the score the higher the reading ability.|Baseline to end of intervention (week 14)|participants completing each arm||units on a scale||Standard Deviation|Mean
823333|NCT01171677|Primary|Controlled Oral Word Association Test (COWAT)|Controlled Oral Word Association Test (COWAT) measures verbal fluency. The assessment consists of three trials; the total score is a sum of all three trials. The scale ranges from 0-90, the higher the score the higher the verbal fluency.|Baseline to end of intervention (week 14)|participants completing each arm||units on a scale||Standard Deviation|Mean
823334|NCT01171677|Primary|Digit Span|Digit span measures attention efficiency. The Digit-span task is used to measure verbal working memory. Two subscales, Digits Forward and Digits Backward, were combined for a total scale range from 0-30, the higher the score the better the working memory.|Baseline to end of intervention (week 14)|participants completing each arm||units on a scale||Standard Deviation|Mean
823335|NCT01171677|Primary|Trailmaking Test B|Trailmaking Test A and B measures cognitive shifting, visual search speed, scanning, speed of processing, mental flexibility, as well as executive functioning. The test generally requires ability to sequence (Parts A and B), ability to shift cognitive set (Part B), and processing speed (Parts A and B). Part A and Part B are scored separately and expressed in terms of the number of seconds it takes the participant to complete each section, the higher the score the longer it took the subject to complete the test. Trailmaking Part B examines executive functioning and ability to shift cognitive set. The lower the score the faster the ability to shift cognitive set.|Baseline to end of intervention (week 14)|participants completing each arm||seconds||Standard Deviation|Mean
823336|NCT01171677|Primary|Trailmaking Test A|Trailmaking Test A and B measures cognitive shifting, visual search speed, scanning, speed of processing, mental flexibility, as well as executive functioning. The test generally requires ability to sequence (Parts A and B), ability to shift cognitive set (Part B), and processing speed (Parts A and B). Part A and Part B are scored separately and expressed in terms of the number of seconds it takes the participant to complete each section, the higher the score the longer it took the subject to complete the test. Trailmaking Part A assesses cognitive processing speed. The lower the score the faster the processing speed.|Baseline to end of intervention (week 14)|participants completing trial||seconds||Standard Deviation|Mean
823337|NCT01171677|Primary|Stroop Color/Word|Stroop Color Word Test assesses cognitive flexibility, resistance to interference from outside stimuli, creativity, psychopathology and cognitive complexity. The Stroop consists of three subscales: Word, Color, and Color-Word. The Stroop Color-Word test is the third subscale administered. The raw score is determined by the number of correct responses within a 90-second period. The scale ranges from 0-100, the higher score the greater the cognitive flexibility and resistance to interference.|Baseline to end of intervention (week 14)|participants completing each arm||units on a scale||Standard Deviation|Mean
823338|NCT01171677|Primary|Stroop Color|Stroop Color Word Test assesses cognitive flexibility, resistance to interference from outside stimuli, creativity, psychopathology and cognitive complexity. The Stroop consists of three subscales: Word, Color, and Color-Word. The Stroop Color test is the second subscale administered. The raw score is determined by the number of correct responses within a 90-second period. The scale ranges from 0-100, the higher score the greater the cognitive flexibility.|Baseline to end of intervention (week 14)|participants completing each arm||units on a scale||Standard Deviation|Mean
823339|NCT01171677|Primary|Stroop Word|Stroop Color Word Test assesses cognitive flexibility, resistance to interference from outside stimuli, creativity, psychopathology and cognitive complexity. The Stroop consists of three subscales: Word, Color, and Color-Word. The Stroop Word test is the first subscale administered. The raw score is determined by the number of correct responses within a 90-second period. The scale ranges from 0-100, the higher score the greater the cognitive flexibility.|Baseline to end of intervention (week 14)|participants completing each arm||units on a scale||Standard Deviation|Mean
823340|NCT01171677|Primary|Hopkins Verbal Learning Test (HVLT) Delayed Recognition|Hopkins Verbal Learning Test (HVLT) assesses Verbal learning and memory, immediate recall, delayed recall, and delayed recognition. The HVLT is comprised of three subscales: HVLT Total Recall, HVLT Delayed Recall, and HVLT Delayed Recognition. HVLT Delayed Recognition is administered immediately after the HVLT Delayed Recall subscale and involves 12 forced choice responses. The HVLT Delayed Recognition scale ranges from 0-24, the higher score associated with greater recognition ability.|Baseline to end of intervention (week 14)|participants completing each arm||units on a scale||Standard Deviation|Mean
823341|NCT01171677|Primary|Hopkins Verbal Learning Test (HVLT) Delayed Recall|Hopkins Verbal Learning Test (HVLT) assesses Verbal learning and memory, immediate recall, delayed recall, and delayed recognition. The HVLT is comprised of three subscales: HVLT Total Recall, HVLT Delayed Recall, and HVLT Delayed Recognition. HVLT Delayed Recall is administered 20-25 minutes after the HVLT Total Recall. The HVLT Delayed Recall scale ranges from 0-12, the higher score associated with greater retention.|Baseline to end of intervention (week 14)|participants completing each arm||units on a scale||Standard Deviation|Mean
823467|NCT01172600|Secondary|Biomarkers|BIOMARKERS: IL-1β, IL-6, IL-10, 1L-17A, IFN-γ, and TNF-α|before 2nd block, typically at 1 month from baseline|10 Entonox patients and 11 Oxygen patients did not come for 2nd block. Among patients came for the 2nd block, blood sample was not collected in 9 Entonox patients and 6 Oxygen patients.||pg/ml||Inter-Quartile Range|Median
823342|NCT01171677|Primary|Hopkins Verbal Learning Test (HVLT) Total Recall|The Hopkins Verbal Learning Test (HVLT) assesses Verbal learning and memory, immediate recall, delayed recall, and delayed recognition. The HVLT is comprised of three subscales: HVLT Total Recall, HVLT Delayed Recall, and HVLT Delayed Recognition. HVLT Total Recall is the sum of 3 trials in which twelve words are read to and repeated back by subject. The HVLT Total Recall scale ranges from 0-36, the higher score associated with greater verbal learning.|Baseline to end of intervention (week 14)|participants completing each arm||units on a scale||Standard Deviation|Mean
823343|NCT01171690|Secondary|Safety Analysis|Arms were compared for total number of adverse events, including severe and serious adverse events.|Approximately 90 days after surgery|||events|||Number
823344|NCT01171690|Primary|Hospital Length of Stay|"Hospital length of stay from initiation of therapy with calcium and calcitriol to ready to discharge from a calcium perspective (calcium level > 7.5 mg/dL and increasing x 2 over 12 hours in an asymptomatic patient with stable therapy and no need for intravenous (IV) calcium in last 24 hours)."|Approximately 7 days after surgery|||days||Standard Deviation|Mean
823345|NCT01171794|Primary|Acute Mountain Sickness Severity|Lake Louise Criteria scores range from 0-15 with higher scores representing more severe symptoms|2 days|Participants meeting all inclusion criteria were analyzed||units on a scale||Standard Deviation|Mean
823346|NCT01171794|Primary|Acute Mountain Sickness|Lake Louise Criteria scores range from 0-15 with higher scores representing more severe symptoms; scores of 3 or greater with presence of a headache considered a positive diagnosis of acute mountain sickness|2 days|Participants meeting all inclusion criteria were analyzed||Participants|||Count of Participants
823347|NCT01171820|Secondary|Adjudicated Composite Endpoint of All Death, Any Myocardial Infarction (MI) and Any Revascularization (TLR/TVR/Non TVR)|"Death defined by the Academic Research Consortium is as follows: All death is considered to be cardiac death unless an unequivocal noncardiac cause can be established.
MI- due to target vessel: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.
Any revascularization: TLR or TVR or non-TVR"|393 days|Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.||Percentage of participants||95% Confidence Interval|Number
823348|NCT01171820|Secondary|Adjudicated Composite Endpoint of All Death, Any Myocardial Infarction (MI) and Any Revascularization (TLR/TVR/Non TVR)|"Death defined by the Academic Research Consortium is as follows: All death is considered to be cardiac death unless an unequivocal noncardiac cause can be established.
MI- due to target vessel: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.
Any revascularization: TLR or TVR or non-TVR"|254 days|Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.||Percentage of participants||95% Confidence Interval|Number
823349|NCT01171820|Secondary|Adjudicated Composite Endpoint of All Death, Any Myocardial Infarction (MI) and Any Revascularization (TLR/TVR/Non-TVR)|"Death defined by the Academic Research Consortium is as follows: All death is considered to be cardiac death unless an unequivocal noncardiac cause can be established.
MI- due to target vessel: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.
Any revascularization: TLR or TVR or non-TVR"|37 days|Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.||Percentage of participants||95% Confidence Interval|Number
823350|NCT01171820|Secondary|Adjudicated Composite Endpoint of All Death, MI and Target Vessel Revascularization (TVR)|"Death defined by the Academic Research Consortium is as follows: All death is considered to be cardiac death unless an unequivocal noncardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal noncardiac disease (eg, cancer, infection) should be classified as cardiac.
Myocardial infarction: Myocardial Infarction Classification and Criteria for Diagnosis as defined by the Academic Research Consortium.
Target Vessel Revascularization (TVR): Target vessel revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion, which includes upstream and downstream branches and the target lesion itself."|393 days|Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.||Percentage of participants||95% Confidence Interval|Number
823351|NCT01171820|Secondary|Adjudicated Composite Endpoint of All Death, MI and Target Vessel Revascularization (TVR)|"Death defined by the Academic Research Consortium is as follows: All death is considered to be cardiac death unless an unequivocal noncardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal noncardiac disease (eg, cancer, infection) should be classified as cardiac.
Myocardial infarction: Myocardial Infarction Classification and Criteria for Diagnosis as defined by the Academic Research Consortium.
Target Vessel Revascularization (TVR): Target vessel revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion, which includes upstream and downstream branches and the target lesion itself."|254 days|Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.||Percentage of participants||95% Confidence Interval|Number
823352|NCT01171820|Secondary|Adjudicated Composite Endpoint of All Death, MI and Target Vessel Revascularization (TVR)|"Death defined by the Academic Research Consortium is as follows: All death is considered to be cardiac death unless an unequivocal noncardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal noncardiac disease (eg, cancer, infection) should be classified as cardiac.
Myocardial infarction: Myocardial Infarction Classification and Criteria for Diagnosis as defined by the Academic Research Consortium.
Target Vessel Revascularization (TVR): Target vessel revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion, which includes upstream and downstream branches and the target lesion itself."|37 days|Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.||Percentage of participants||95% Confidence Interval|Number
823468|NCT01172600|Secondary|Biomarkers|BIOMARKERS: IL-1β, IL-6, IL-10, 1L-17A, IFN-γ, and TNF-α|baseline - before 1st block|Blood sample was not collected for 5 Entonox patients and 1 Oxygen patients.||pg/ml||Inter-Quartile Range|Median
823353|NCT01171820|Secondary|Adjudicated Composite Endpoint of Cardiac Death, Myocardial Infarction (MI) Attributed to the Target Vessel and Clinical-indicated Target Lesion Revascularization (CI-TLR)|"Cardiac death: Any death due to proximate cardiac cause (eg, myocardial infarction, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, and all procedure related deaths, including those related to concomitant treatment, will be classified as cardiac death.
MI- due to target vessel: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.
Clinical-indicated Target Lesion Revascularization (CI-TLR): TLR with evidence of diameter stenosis ≥ 50% determined by QCA; or in the case of any one of the following: new recurrent history of angina pectoris, ischemic signs, abnormal results in diagnostic tests, or TLR >=70% in the absence of the above signs."|393 days|Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.||Percentage of participants||95% Confidence Interval|Number
823354|NCT01171820|Secondary|Adjudicated Composite Endpoint of Cardiac Death, Myocardial Infarction (MI) Attributed to the Target Vessel and Clinical-indicated Target Lesion Revascularization (CI-TLR)|"Cardiac death: Any death due to proximate cardiac cause (eg, myocardial infarction, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, and all procedure related deaths, including those related to concomitant treatment, will be classified as cardiac death.
MI- due to target vessel: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.
Clinical-indicated Target Lesion Revascularization (CI-TLR): TLR with evidence of diameter stenosis ≥ 50% determined by QCA; or in the case of any one of the following: new recurrent history of angina pectoris, ischemic signs, abnormal results in diagnostic tests, or TLR >=70% in the absence of the above signs."|254 days|Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.||Percentage of participants||95% Confidence Interval|Number
823355|NCT01171820|Secondary|Adjudicated Composite Endpoint of Cardiac Death, Myocardial Infarction (MI) Attributed to the Target Vessel and Clinical-indicated Target Lesion Revascularization (CI-TLR)|"Cardiac death: Any death due to proximate cardiac cause (eg, myocardial infarction, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, and all procedure related deaths, including those related to concomitant treatment, will be classified as cardiac death.
MI- due to target vessel: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.
Clinical-indicated Target Lesion Revascularization (CI-TLR): TLR with evidence of diameter stenosis ≥ 50% determined by QCA; or in the case of any one of the following: new recurrent history of angina pectoris, ischemic signs, abnormal results in diagnostic tests, or TLR >=70% in the absence of the above signs."|37 days|Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.||Percentage of participants||95% Confidence Interval|Number
823356|NCT01171820|Secondary|Adjudicated Revascularizations (Target Lesion Revascularization (TLR)/ Target Vessel Revascularization (TVR)/Any Revascularization) Both Clinically-indicated and Not Clinically-indicated.|"TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion was defined as the treated segment from 5 mm proximal and 5 mm distal to the stent.
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel was defined as the entire major coronary vessel proximal and distal to the target lesion, including upstream and downstream branches and the target lesion itself.
A revascularization is considered clinically indicated if angiography at follow-up shows a %DS ≥ 50% and if one of the following occurs: history of recurrent angina pectoris due to the target vessel; signs of ischemia at rest or during exercise test due to target vessel; abnormal results of any invasive diagnostic test; TLR or TVR with a % DS ≥ 70% even in the absence of the above mentioned ischemic signs."|393 days|Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.||Percentage of participants||95% Confidence Interval|Number
823357|NCT01171820|Secondary|Adjudicated Revascularizations (Target Lesion Revascularization (TLR)/ Target Vessel Revascularization (TVR)/Any Revascularization) Both Clinically-indicated and Not Clinically-indicated.|"TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion was defined as the treated segment from 5 mm proximal and 5 mm distal to the stent.
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel was defined as the entire major coronary vessel proximal and distal to the target lesion, including upstream and downstream branches and the target lesion itself.
A revascularization is considered clinically indicated if angiography at follow-up shows a %DS ≥ 50% and if one of the following occurs: history of recurrent angina pectoris due to the target vessel; signs of ischemia at rest or during exercise test due to target vessel; abnormal results of any invasive diagnostic test; TLR or TVR with a % DS ≥ 70% even in the absence of the above mentioned ischemic signs."|254 days|Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.||Percentage of participants||95% Confidence Interval|Number
823358|NCT01171820|Secondary|Adjudicated Revascularizations (Target Lesion Revascularization (TLR)/ Target Vessel Revascularization (TVR)/Any Revascularization) Both Clinically-indicated and Not Clinically-indicated.|"TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion was defined as the treated segment from 5 mm proximal and 5 mm distal to the stent.
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel was defined as the entire major coronary vessel proximal and distal to the target lesion, including upstream and downstream branches and the target lesion itself.
A revascularization is considered clinically indicated if angiography at follow-up shows a %DS ≥ 50% and if one of the following occurs: history of recurrent angina pectoris due to the target vessel; signs of ischemia at rest or during exercise test due to target vessel; abnormal results of any invasive diagnostic test; TLR or TVR with a % DS ≥ 70% even in the absence of the above mentioned ischemic signs."|37 days|Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.||Percentage of participants||95% Confidence Interval|Number
823359|NCT01171820|Secondary|Adjudicated Stent Thrombosis (Confirmed/Definite, Probable, Possible)|"The Clinical Event Committee will adjudicate the events according to the definitions developed by the Academic Research Consortium (ARC), as published in Circulation (Cutlip, D.E., et al., Clinical End Points in Coronary Stent Trials: A Case for Standardized Definitions. Circulation, 2007. 115: p. 2344-2351.)
Stent thrombosis was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of stent thrombosis; probable: unexplained death ≤30 days or any MI that is related to acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis; and possible: unexplained death >30 days after stent placement."|365 days|Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.||Percentage of participants||95% Confidence Interval|Number
823360|NCT01171820|Secondary|Adjudicated Stent Thrombosis (Confirmed/Definite, Probable, Possible)|"The Clinical Event Committee will adjudicate the events according to the definitions developed by the Academic Research Consortium (ARC), as published in Circulation (Cutlip, D.E., et al., Clinical End Points in Coronary Stent Trials: A Case for Standardized Definitions. Circulation, 2007. 115: p. 2344-2351.)
Stent thrombosis was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of stent thrombosis; probable: unexplained death ≤30 days or any MI that is related to acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis; and possible: unexplained death >30 days after stent placement."|254 days|Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.||Percentage of participants||95% Confidence Interval|Number
823361|NCT01171820|Secondary|Adjudicated Stent Thrombosis (Confirmed/Definite, Probable, Possible)|"The Clinical Event Committee will adjudicate the events according to the definitions developed by the Academic Research Consortium (ARC), as published in Circulation (Cutlip, D.E., et al., Clinical End Points in Coronary Stent Trials: A Case for Standardized Definitions. Circulation, 2007. 115: p. 2344-2351.)
Stent thrombosis was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of stent thrombosis; probable: unexplained death ≤30 days or any MI that is related to acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis; and possible: unexplained death >30 days after stent placement."|0 to 37 days|Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.||Percentage of participants||95% Confidence Interval|Number
823362|NCT01171820|Secondary|In-segment Percent Diameter Stenosis (% DS)|"This number represents the average of percent diameter stenosis found on examination of all the lesions analyzed.
This value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA."|270 days|Analysis based on intention to treat (ITT) population. Patients were required to have angiographic follow-up to provide this endpoint information. Some patients not completing the study, did not have this follow up. The number of analyzed represents number of patients randomized.||Percent diameter stenosis|Participants|Standard Deviation|Mean
823363|NCT01171820|Secondary|In-stent Percent Diameter Stenosis (% DS)|"This number represents the average of percent diameter stenosis found on examination of all the lesions analyzed.
This value calculated as 100 * (1 - minimum lumen diameter/reference vessel diameter) (MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA."|270 days|Analysis based on intention to treat (ITT) population. Patients were required to have angiographic follow-up to provide this endpoint information. Some patients not completing the study, did not have this follow up. The number of analyzed represents number of patients randomized.||Percent diameter stenosis|Participants|Standard Deviation|Mean
823364|NCT01171820|Secondary|In-segment Angiographic Binary Restenosis Rate|Percent of patients with a follow-up percent diameter stenosis of ≥ 50% per QCA.|270 days|Analysis based on intention to treat (ITT) population. Patients were required to have angiographic follow-up to provide this endpoint information. Some patients not completing the study, did not have this follow up. The number of analyzed represents number of patients randomized.||Percentage of participants|Participants|95% Confidence Interval|Number
823365|NCT01171820|Secondary|In-stent Angiographic Binary Restenosis Rate|Percent of patients with a follow-up percent diameter stenosis of ≥ 50% per QCA.|270 days|Analysis based on intention to treat (ITT) population. Patients were required to have angiographic follow-up to provide this endpoint information. Some patients not completing the study, did not have this follow up. The number of analyzed represents number of patients randomized.||Percentage of participants|Participants|95% Confidence Interval|Number
823366|NCT01171820|Secondary|Distal Late Loss|Distal Minimum Lumen Diameter (MLD) post-procedure minus distal MLD at follow-up|270 days|Analysis based on intention to treat (ITT) population. Patients were required to have angiographic follow-up to provide this endpoint information. Some patients not completing the study, did not have this follow up. The number of analyzed represents number of patients randomized.||millimeters|Participants|Standard Deviation|Mean
823367|NCT01171820|Secondary|Proximal Late Loss|Proximal Minimum Lumen Diameter (MLD) post-procedure minus proximal MLD at follow-up|270 day|Analysis based on intention to treat (ITT) population. Patients were required to have angiographic follow-up to provide this endpoint information. Some patients not completing the study, did not have this follow up. The number of analyzed represents number of patients randomized.||millimeters|Participants|Standard Deviation|Mean
823368|NCT01171820|Secondary|In-segment Late Loss|In-segment minimal lumen diameter (MLD) post-procedure minus (-) in segment MLD at follow-up|270 days|Analysis based on intention to treat (ITT) population. Patients were required to have angiographic follow-up to provide this endpoint information. Some patients not completing the study, did not have this follow up. The number of analyzed represents number of patients randomized.||millimeters|Participants|Standard Deviation|Mean
823388|NCT01171963|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, or result in disability/incapacity. Any = occurrence of an SAE regardless of the intensity grade or relationship to vaccination.|Throughout the entire study period (from Day 0 to Study End at Month 21)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the Rotarix™ vaccine or placebo administration documented.||Subjects|||Number
823469|NCT01172600|Secondary|Usage of Opioid||3 months follow-up after last block (maximum of 3 blocks with a typical 1 month interval between blocks)|5 patients in each group were lost follow up.||participants|||Number
823369|NCT01171820|Secondary|Clinical Procedure Success (Per-patient)|Successful delivery and deployment of the study stent or stents at the intended target lesion and successful withdrawal of the stent delivery system with attainment of final residual stenosis of less than 50% of the target lesion by quantitative coronary angiography (QCA) (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of cardiac death, MI attributed to the target vessel and/or CI-TLR during the hospital stay with a maximum of first seven days post index procedure. In multiple lesion setting each lesion must meet clinical procedure success.|immediately post-procedure|The sample size for clinical procedure success is based on the number of evaluable patients, for whom data is available to define clinical procedure success.||Percentage of participants||95% Confidence Interval|Number
823370|NCT01171820|Secondary|Clinical Device Success (Per-lesion)|Successful delivery and deployment of the study stent (in overlapping stent setting a successful delivery and deployment of the first and second study stent) at the intended target lesion and successful withdrawal of the stent delivery system with attainment of final residual stenosis of less than 50% of the target lesion by quantitative coronary angiography (QCA) (by visual estimation if QCA unavailable), without use of a device outside the assigned treatment strategy.|immediately post-procedure|Analysis based on intention to treat (ITT) population.||Percentage of lesions|Participants|95% Confidence Interval|Number
823371|NCT01171820|Primary|In-stent Late Loss (LL)|In-stent minimal lumen diameter (MLD) post-procedure minus (-) in-stent MLD at follow-up|270 days|Analysis based on intention to treat (ITT) population. Patients were required to have angiographic follow-up to provide this endpoint information. Some patients not completing the study, did not have this follow up.||millimeters|Participants|Standard Deviation|Mean
823372|NCT01171924|Primary|Number of Participants With Adverse Events|Safety and tolerability will be assessed in the two treatment arms and the incidence of adverse events will be compared.|12-15 months|||participants|||Number
823373|NCT01171963|Secondary|Concentrations of Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies|Antibody assessment was performed by enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA units per milliliter (EL.U/mL). The cut-off of the assay was the seropositivity cut-off (≥ 5 EL.U/mL) for all antibodies assessed (anti-PT, anti-FHA and anti-PRN). This outcome measure concerns solely subjects in Sub-cohort 2, who received the EPI vaccination concomitantly with study vaccination with the Rotarix™ vaccine/placebo.|At Day 0 and at Month 4|Analysis was performed on the ATP cohort for immunogenicity Sub-cohort 2, which included subjects with OPV and Infanrix™ vaccines co-administered with the study vaccine, complying with protocol, with EPI childhood vaccinations completed according to Chinese recommendations and available immunogenicity data at post sampling time-point.||EL.U/mL||95% Confidence Interval|Geometric Mean
823374|NCT01171963|Secondary|Number of Subjects Seropositive for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies.|Antibody assessment was performed by enzyme-linked immunosorbent assay (ELISA). A subject seropositive for anti-PT/anti-FHA/anti-PRN antibodies was defined as a subject with an anti-PT/anti-FHA/anti-PRN antibody concentrations greater than or equal to (≥) 5 ELISA units per milliliter (EL.U/mL). This outcome measure concerns solely subjects in Sub-cohort 2, who received the EPI vaccination concomitantly with study vaccination with the Rotarix™ vaccine/placebo.|At Day 0 and at Month 4|Analysis was performed on the ATP cohort for immunogenicity Sub-cohort 2, which included subjects with OPV and Infanrix™ vaccines co-administered with the study vaccine, complying with protocol, with EPI childhood vaccinations completed according to Chinese recommendations and available immunogenicity data at post sampling time-point.||Subjects|||Number
823375|NCT01171963|Secondary|Titers for Anti-poliovirus Type 1 (Anti-polio 1), Anti-polio 2 and Anti-polio 3 Antibodies|Titers were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seroprotection cut-off (≥ 8 estimated doses 50% [ED50] for anti-poliovirus type 1 [anti-polio 1]/anti-polio 2/anti-polio 3 antibodies. This outcome measure concerns solely subjects in Sub-cohort 2, who received the EPI vaccination concomitantly with study vaccination with the Rotarix™ vaccine/placebo.|At Day 0 and at Month 4|Analysis was performed on the ATP cohort for immunogenicity Sub-cohort 2, which included subjects with OPV and Infanrix™ vaccines co-administered with the study vaccine, complying with protocol, with EPI childhood vaccinations completed according to Chinese recommendations and available immunogenicity data at post sampling time-point.||titers||95% Confidence Interval|Geometric Mean
823376|NCT01171963|Secondary|Number of Subjects Seroprotected Against Poliovirus Types 1, 2 and 3.|A subject seroprotected against poliovirus types 1, 2 and 3 was defined as a subject with anti-poliovirus type 1 (anti-polio 1)/anti-polio 2/anti-polio 3 antibody titer greater than or equal to (≥) 8 estimated doses 50% (ED50). This outcome measure concerns solely subjects in Sub-cohort 2, who received the EPI vaccination concomitantly with study vaccination with the Rotarix™ vaccine/placebo (cf. population definition below).|At Day 0 and at Month 4|Analysis was performed on the ATP cohort for immunogenicity Sub-cohort 2, which included subjects with OPV and Infanrix™ vaccines co-administered with the study vaccine, complying with protocol, with EPI childhood vaccinations completed according to Chinese recommendations and available immunogenicity data at post sampling time-point.||Subjects|||Number
823377|NCT01171963|Secondary|Anti-Diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations|Concentrations were expressed as geometric mean concentrations (GMCs) in international unit per milliliter (IU/mL). The cut-off of the assay was the seroprotection cut-off assay (≥ 0.1 IU/mL). This outcome measure concerns solely subjects in Sub-cohort 2, who received the EPI vaccination concomitantly with study vaccination with the Rotarix™ vaccine/placebo.|At Day 0 and at Month 4|Analysis was performed on the ATP cohort for immunogenicity Sub-cohort 2, which included subjects with OPV and Infanrix™ vaccines co-administered with the study vaccine, complying with protocol, with EPI childhood vaccinations completed according to Chinese recommendations and available immunogenicity data at post sampling time-point.||IU/mL||95% Confidence Interval|Geometric Mean
823416|NCT01171989|Secondary|Number of Seropositive Subjects for Anti-poliovirus Types 1, 2 and 3|A seropositive subject was defined as a subject with anti-polio type 1, 2 or 3 ≥ 1:8.|At Month 0 and Month 1, before and one month after booster dose|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Participants|||Count of Participants
823378|NCT01171963|Secondary|Number of Subjects Seroprotected Against Diphtheria and Tetanus|A subject seroprotected against diphtheria/tetanus was defined as a subject with an anti-diphtheria (anti-D)/anti-tetanus (anti-T) antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL). This outcome measure concerns solely subjects in Sub-cohort 2, who received the EPI vaccination concomitantly with study vaccination with the Rotarix™ vaccine/placebo|At Day 0 and at Month 4|Analysis was performed on the ATP cohort for immunogenicity Sub-cohort 2, which included subjects with OPV and Infanrix™ vaccines co-administered with the study vaccine, complying with protocol, with EPI childhood vaccinations completed according to Chinese recommendations and available immunogenicity data at post sampling time-point.||Subjects|||Number
823379|NCT01171963|Secondary|Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibody Concentrations.|Concentrations were expressed as geometric mean concentrations (GMCs), in units per milliliter (U/mL). The cut-off of the assay was the seropositivity cut-off (≥ 20 U/mL).|At Day 0, Month 2 and at 12 months of age|Analysis was performed on the ATP cohort for immunogenicity, which included eligible subjects in the ATP cohorts for immunogenicity sub-cohorts 1 and 2 seronegative for serum anti-rotavirus immunoglobulin A (IgA) antibodies at Day 0 and with availability immunogenicity data at pre and post sampling time-points.||U/mL||95% Confidence Interval|Geometric Mean
823380|NCT01171963|Secondary|Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibody Concentrations.|Concentrations were expressed as geometric mean concentrations (GMCs), in units per milliliter (U/mL). The cut-off of the assay was the seropositivity cut-off (≥ 20 U/mL).|At Day 0, Month 2 and at 12 months of age.|Analysis was performed on the ATP cohort for immunogenicity Sub-cohort 2, which included subjects with OPV and Infanrix™ vaccines co-administered with the study vaccine, complying with protocol, with EPI childhood vaccinations completed according to Chinese recommendations and available immunogenicity data at post sampling time-point.||U/mL||95% Confidence Interval|Geometric Mean
823381|NCT01171963|Secondary|Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibody Concentrations|Concentrations were expressed as geometric mean concentrations (GMCs), in units per milliliter (U/mL). The cut-off of the assay was the seropositivity cut-off (≥ 20 U/mL).|At Day 0, Month 2 and at 12 months of age|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity Sub-cohort 1, which included subjects vaccinated with at least 1 dose of HRV vaccine/Placebo, complying with protocol, with EPI childhood vaccinations completed according to Chinese recommendations and available immunogenicity data at post sampling time-point.||U/mL||95% Confidence Interval|Geometric Mean
823382|NCT01171963|Secondary|Number of Subjects Seropositive for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibodies.|A subject seropositive for anti-rotavirus (anti-RV) immunoglobulin A (IgA) antibodies was defined as a subject anti-RV IgA antibody concentration greater than or equal to (≥) the seropositivity cut-off of 20 units per milliliter (U/mL).|At Day 0, Month 2 and at 12 months of age|Analysis was performed on the ATP cohort for immunogenicity, which included eligible subjects in the ATP cohorts for immunogenicity sub-cohorts 1 and 2 seronegative for serum anti-rotavirus immunoglobulin A (IgA) antibodies at Day 0 and with availability immunogenicity data at pre and post sampling time-points.||Subjects|||Number
823383|NCT01171963|Secondary|Number of Subjects Seropositive for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibodies.|A subject seropositive for anti-rotavirus (anti-RV) immunoglobulin A (IgA) antibodies was defined as a subject anti-RV IgA antibody concentration greater than or equal to (≥) the seropositivity cut-off of 20 units per milliliter (U/mL).|At Day 0, Month 2 and at 12 months of age|Analysis was performed on the ATP cohort for immunogenicity Sub-cohort 2, which included subjects with OPV and Infanrix™ vaccines co-administered with the study vaccine, complying with protocol, with EPI childhood vaccinations completed according to Chinese recommendations and available immunogenicity data at post sampling time-point.||Subjects|||Number
823384|NCT01171963|Secondary|Number of Subjects Seropositive for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibodies.|A subject seropositive for anti-rotavirus (anti-RV) immunoglobulin A (IgA) antibodies was defined as a subject anti-RV IgA antibody concentration greater than or equal to (≥) the seropositivity cut-off of 20 units per milliliter (U/mL).|At Day 0, Month 2 and at 12 months of age|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity Sub-cohort 1, which included subjects vaccinated with at least 1 dose of HRV vaccine/Placebo, complying with protocol, with EPI childhood vaccinations completed according to Chinese recommendations and available immunogenicity data at post sampling time-point.||Subjects|||Number
823385|NCT01171963|Secondary|Number of Seroconverted Subjects for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibodies.|A seroconverted subject was defined as a subject seronegative at baseline (Day 0) with the appearance of anti-RV IgA antibody concentration greater than or equal to (≥) 20 units per milliliter (U/mL) at the time point assessed. A seronegative subject was defined as a subject with anti-RV IgA antibody concentration lower than (<) 20 U/mL.|At Month 2 and at 12 months of age|Analysis was performed on the ATP cohort for immunogenicity, which included eligible subjects in the ATP cohorts for immunogenicity sub-cohorts 1 and 2 seronegative for serum anti-rotavirus immunoglobulin A (IgA) antibodies at Day 0 and with availability immunogenicity data at pre and post sampling time-points.||Subjects|||Number
823386|NCT01171963|Secondary|Number of Seroconverted Subjects for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibodies.|A seroconverted subject was defined as a subject seronegative at baseline (Day 0) with the appearance of anti-RV IgA antibody concentration greater than or equal to (≥) 20 units per milliliter (U/mL) at the time point assessed. A seronegative subject was defined as a subject with anti-RV IgA antibody concentration lower than (<) 20 U/mL.|At Month 2 and at 12 months of age|Analysis was performed on the ATP cohort for immunogenicity Sub-cohort 2, which included subjects with OPV and Infanrix™ vaccines co-administered with the study vaccine, complying with protocol, with EPI childhood vaccinations completed according to Chinese recommendations and available immunogenicity data at post sampling time-point.||Subjects|||Number
823387|NCT01171963|Secondary|Number of Seroconverted Subjects for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibodies|A seroconverted subject was defined as a subject seronegative at baseline (Day 0) with the appearance of anti-RV IgA antibody concentration greater than or equal to (≥) 20 units per milliliter (U/mL) at the time point assessed. A seronegative subject was defined as a subject with anti-RV IgA antibody concentration lower than (<) 20 U/mL.|At Month 2 and at 12 months of age|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity Sub-cohort 1, which included subjects vaccinated with at least 1 dose of HRV vaccine/Placebo, complying with protocol, with EPI childhood vaccinations completed according to Chinese recommendations and available immunogenicity data at post sampling time-point.||Subjects|||Number
823389|NCT01171963|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an unsolicited AE regardless of the intensity grade or relationship to vaccination.|Within the 31-day (Days 0–30) follow-up periods following any dose of the Rotarix™ vaccine or placebo|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the Rotarix™ vaccine or placebo administration documented.||Subjects|||Number
823390|NCT01171963|Secondary|Number of Subjects With Any Solicited Local Symptoms Following Dose 2 of the Rotarix™ Vaccine/Placebo|Solicited local symptoms assessed following administration of the co-administered EPI vaccines were pain, swelling, and redness. Any = any occurrence of the specified solicited local symptom regardless of the intensity grade. This outcome measure was only assessed in subjects from Sub-cohort 2, who received the EPI vaccination concomitantly with study vaccination with the Rotarix™ vaccine/placebo.|Within the 8-day (Days 0–7) follow-up periods following Dose 2 of the Rotarix™ vaccine/placebo|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the Rotarix™ vaccine or placebo administration documented only on subjects in sub-cohort 2, for whom results were available.||Subjects|||Number
823391|NCT01171963|Secondary|Number of Subjects With Any Solicited General Symptoms Following Administration of the Co-administered EPI Vaccines|Solicited general symptoms assessed following administration of the co-administered EPI vaccines were drowsiness, gastrointestinal symptoms, fussiness/irritability, loss of appetite, and fever, defined as axillary temperature (T) above or equal to [>=] 37.5 degrees Celsius [°C] (if GSK scale) or >= 37.1°C (if Chinese scale ). Any = any occurrence of the specified solicited general symptom regardless of the intensity grade or relationship to vaccination. This outcome measure was only assessed in subjects from Sub-cohort 2, who received the EPI vaccination concomitantly with study vaccination with the Rotarix™ vaccine/placebo.|Within the 8-day (Days 0–7) follow-up periods following Doses 1 and 2 of the OPV vaccine and Dose 1 of the Infanrix™ vaccine|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the Rotarix™ vaccine or placebo administration documented only on subjects in sub-cohort 2, for whom results were available.||Subjects|||Number
823392|NCT01171963|Secondary|Number of Subjects With Any Solicited General Symptoms Following Vaccination With the Rotarix™ Vaccine/Placebo|Assessed solicited general symptoms were fever,defined as axillary temperature (T) above or equal to [>=] 37.5 degrees Celsius [°C] (if GSK scale) or >= 37.1°C (if Chinese scale), fussiness/irritability, loss of appetite, cough/runny nose, diarrhea and vomiting. Any = any occurrence of the specified solicited general symptom regardless of the intensity grade or relationship to vaccination. This outcome measure was only assessed in subjects from Sub-cohort 1, who received the EPI vaccination independently of study vaccination with the Rotarix™ vaccine/placebo.|Within the 8-day (Days 0–7) follow-up periods after any dose of Rotarix™ vaccine/placebo|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the Rotarix™ vaccine or placebo administration documented, solely on subjects not part of Sub-cohort 2.||Subjects|||Number
823393|NCT01171963|Secondary|Number of Subjects With Any and Severe Gastroenteritis (GE) Due to Any Cause|Severe GE was defined as an episode of GE with score equal to or higher than (>=) 11 on a 20-point Vesikari scoring system. This outcome measure concerns results for GE episodes due to any cause.|From Month 1 ½ to Month 21|The analysis was performed on the According-to-Protocol cohort for efficacy, which included subjects vaccinated with Rotarix™ vaccine or placebo who had entered the efficacy surveillance period (Months 1 ½-21) with no rotavirus other than vaccine strain in the gastroenteritis stool samples collected between Day 0 and Month 1 ½.||Subjects|||Number
823394|NCT01171963|Secondary|Number of Subjects With Episodes of Rotavirus Gastroenteritis (RVGE) Caused by the Circulating Wild Type (WT) Strains Requiring Hospitalization|A gastroenteritis episode was classified positive for rotavirus (RV) and caused by the circulating WT RV strains if RV other than the vaccine strain was identified in a stool sample collected during the episode.|From Month 1 ½ to Month 21|The analysis was performed on the According-to-Protocol cohort for efficacy, which included subjects vaccinated with Rotarix™ vaccine or placebo who had entered the efficacy surveillance period (Months 1 ½-21) with no rotavirus other than vaccine strain in the gastroenteritis stool samples collected between Day 0 and Month 1 ½.||Subjects|||Number
823395|NCT01171963|Secondary|Number of Subjects With Severe Episode(s) of Rotavirus Gastroenteritis (RVGE) of Any Type.|A gastroenteritis episode was classified positive for rotavirus (RV) if RV was identified in a stool sample collected during the episode. Severe RVGE was defined as an episode of RVGE with score equal to or higher than (>=) 11 on a 20-point Vesikari scoring system. RV types assessed were G1 Wild Type (G1WT), G2, G3, G9, GX (G type unknown, but not vaccine strain), P4, P8 Wild Type (P8WT), P9, PX (P type unknown, but not vaccine strain) and Pooled Non-G1WT.|From Month 1 ½ to Month 21|The analysis was performed on the According-to-Protocol cohort for efficacy, which included subjects vaccinated with Rotarix™ vaccine or placebo who had entered the efficacy surveillance period (Months 1 ½-21) with no rotavirus other than vaccine strain in the gastroenteritis stool samples collected between Day 0 and Month 1 ½.||Subjects|||Number
823396|NCT01171963|Secondary|Number of Subjects With Any Episode(s) of Rotavirus Gastroenteritis (RVGE) of Any Type.|A gastroenteritis episode was classified positive for rotavirus (RV) if RV was identified in a stool sample collected during the episode. RV types assessed were G1 Wild Type (G1WT), G2, G3, G9, GX (G type unknown, but not vaccine strain), P4, P8 Wild Type (P8WT), P9, PX (P type unknown, but not vaccine strain) and Pooled Non-G1WT.|From Month 1 ½ to Month 21|The analysis was performed on the According-to-Protocol cohort for efficacy, which included subjects vaccinated with Rotarix™ vaccine or placebo who had entered the efficacy surveillance period (Months 1 ½-21) with no rotavirus other than vaccine strain in the gastroenteritis stool samples collected between Day 0 and Month 1 ½.||Subjects|||Number
823417|NCT01171989|Secondary|Anti-HBs Antibody Concentrations|Concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.|At Month 0 and Month 1, before and after booster dose|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||mIU/mL||95% Confidence Interval|Geometric Mean
823397|NCT01171963|Secondary|Number of Subjects With Any Episode(s) of Rotavirus Gastroenteritis (RVGE) Caused by the Circulating Wild-type Strains|A gastroenteritis episode was classified positive for rotavirus (RV) and caused by the circulating wild-type (WT) RV strains if RV other than the vaccine strain was identified in a stool sample collected during the episode.|From Month 1 ½ to Month 21|The analysis was performed on the According-to-Protocol cohort for efficacy, which included subjects vaccinated with Rotarix™ vaccine or placebo who had entered the efficacy surveillance period (Months 1 ½-21) with no rotavirus other than vaccine strain in the gastroenteritis stool samples collected between Day 0 and Month 1 ½.||Subjects|||Number
823398|NCT01171963|Primary|Number of Subjects With Severe Episode(s) of Rotavirus Gastroenteritis (RVGE) Caused by the Circulating Wild Type (WT) Strains|A gastroenteritis episode was classified positive for rotavirus (RV) and caused by the circulating wild-type (WT) RV strains if RV other than the vaccine strain was identified in a stool sample collected during the episode. Severe RVGE was defined as an episode of RV GE with score equal to or higher than (>=) 11 on a 20-point Vesikari scoring system.|From Month 1 ½ to Month 21|The analysis was performed on the According-to-Protocol cohort for efficacy, which included subjects vaccinated with Rotarix™ vaccine or placebo who had entered the efficacy surveillance period (Months 1 ½-21) with no rotavirus other than vaccine strain in the gastroenteritis stool samples collected between Day 0 and Month 1 ½.||Subjects|||Number
823399|NCT01171976|Secondary|EuroQoL (EQ-5D) Thermometer Score: Change From Baseline at Month 12 and Month 24|The Euro Quality of Life Questionnaire (EQ-5D) is an indirect utility questionnaire. It is a standardized instrument was utilized to measure health outcomes related to 5 dimensions, namely: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The possible range for each dimension was 1 to 3, where 1= “no problems”, 2=“some problems” and 3=“extreme problems” . A composite health index was then defined by combining the levels for each dimension. Overall, 243 health states are possible. For each health state, the EuroQol group has assigned a utility value typically between 0 and 1 with lower scores representing a higher level of dysfunction|Baseline, Month 12 and Month 24|Analyzed set included all randomized patients who received at least one application of study treatment and had at least one post baseline efficacy assessment. If missing values occurred without a subsequent observed value, the last observed value was carried forward to subsequent scheduled visits by means of a last observation carried forward.||Score on a scale||Standard Deviation|Mean
823400|NCT01171976|Secondary|Visual Functioning Questionnaire (VFQ-25) Change From Baseline in Total Score at Month 12 and Month 24|The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) was used to measure the influence of visual disability and symptoms on general health. The 12 subscales in the VFQ-25 are general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. For each, the patient was asked to rate their condition on a scale of 1-5 or 1-6, where a low number reflects a better outcome. Each response was recoded per the scoring rules outlined in the National Eye Institute (NEI) VFQ-25 Scoring Algorithm. Under this scoring algorithm , the recoded values range between 0 and 100 and a high score means a better functioning|Baseline, Month 12 and Month 24|Analyzed set included all randomized patients who received at least one application of study treatment and had at least one post baseline efficacy assessment. If missing values occurred without a subsequent observed value, the last observed value was carried forward to subsequent scheduled visits by means of a last observation carried forward.||Score on a scale||Standard Deviation|Mean
823401|NCT01171976|Secondary|Central Subfield Thickness of the Study Eye: Percent Change From Baseline at Month 24|High Resolution OCT was performed at every study visit by Spectral Domain OCT (if not available Time Domain OCT was acceptable) and the images were transferred to a digital video disc. These assessments were performed by trained and adequately qualified experts at the sites and prior to any study drug administration. CSFT is the average retinal thickness of the circular area with 1 mm diameter around the foveal center.|Baseline and 24 month|Analyzed set included all randomized patients who received at least one application of study treatment and had at least one post baseline efficacy assessment. If missing values occurred without a subsequent observed value, the last observed value was carried forward to subsequent scheduled visits by means of a last observation carried forward.||Percent Change||Standard Deviation|Mean
823402|NCT01171976|Secondary|Central Subfield Thickness of the Study Eye: Percent Change From Baseline at Month 12|High Resolution OCT was performed at every study visit by Spectral Domain OCT (if not available Time Domain OCT was acceptable) and the images were transferred to a digital video disc. These assessments were performed by trained and adequately qualified experts at the sites and prior to any study drug administration. CSFT is the average retinal thickness of the circular area with 1 mm diameter around the foveal center.|Baseline, Month 12|Analyzed set included all randomized patients who received at least one application of study treatment and had at least one post baseline efficacy assessment. If missing values occurred without a subsequent observed value, the last observed value was carried forward to subsequent scheduled visits by means of a last observation carried forward.||Percent Change||Standard Deviation|Mean
823403|NCT01171976|Secondary|Visual Acuity of the Study Eye: Categorized Change From Baseline at Month 24|Visual acuity was assessed at every study visit for the study eye using best correction determined from protocol refraction. The BCVA measurements were taken in a sitting position using ETDRS–like VA testing charts at a starting distance of 4 meters.|Baseline, 24 month|Analyzed set included all randomized patients who received at least one application of study treatment and had at least one post baseline efficacy assessment. If missing values occurred without a subsequent observed value, the last observed value was carried forward to subsequent scheduled visits by means of a last observation carried forward.||Percentage of pateints|||Number
823404|NCT01171976|Secondary|Visual Acuity of the Study Eye: Categorized Change From Baseline at Month 12|Visual acuity was assessed at every study visit for the study eye using best correction determined from protocol refraction. The BCVA measurements were taken in a sitting position using ETDRS–like VA testing charts at a starting distance of 4 meters.|Baseline, Month 12|Analyzed set included all randomized patients who received at least one application of study treatment and had at least one post baseline efficacy assessment. If missing values occurred without a subsequent observed value, the last observed value was carried forward to subsequent scheduled visits by means of a last observation carried forward.||Percentage of patients|||Number
823470|NCT01172600|Secondary|Usage of Opioid||3rd block, typically at 2 months from baseline|21 Entonox patients and 26 Oxygen patients did not receive 2nd block.||participants|||Number
823405|NCT01171976|Secondary|Visual Acuity of the Study Eye: Change From Baseline at Month 24|Visual acuity was assessed at every study visit for the study eye using best correction determined from protocol refraction. The BCVA measurements were taken in a sitting position using ETDRS–like VA testing charts at a starting distance of 4 meters.|Baseline and Month 24|Analyzed set included all randomized patients who received at least one application of study treatment and had at least one post baseline efficacy assessment. If missing values occurred without a subsequent observed value, the last observed value was carried forward to subsequent scheduled visits by means of a last observation carried forward.||Letters||Standard Deviation|Mean
823406|NCT01171976|Secondary|Visual Acuity of the Study Eye: Change From Baseline at Month 12|Visual acuity was assessed at every study visit for the study eye using best correction determined from protocol refraction. The BCVA measurements were taken in a sitting position using ETDRS–like VA testing charts at a starting distance of 4 meters.|Baseline and Month 12|Analyzed set included all randomized patients who received at least one application of study treatment and had at least one post baseline efficacy assessment. If missing values occurred without a subsequent observed value, the last observed value was carried forward to subsequent scheduled visits by means of a last observation carried forward.||Letters||Standard Deviation|Mean
823407|NCT01171976|Secondary|Visual Acuity of the Study Eye: Average Change From Baseline to Month 1 Through Month 24|Visual acuity was assessed at every study visit for the study eye using best correction determined from protocol refraction. The BCVA measurements were taken in a sitting position using ETDRS–like VA testing charts at a starting distance of 4 meters.|Baseline to Month 24|Analyzed set included all randomized patients who received at least one application of study treatment and had at least one post baseline efficacy assessment. If missing values occurred without a subsequent observed value, the last observed value was carried forward to subsequent scheduled visits by means of a last observation carried forward.||Letters||Standard Deviation|Mean
823408|NCT01171976|Primary|Visual Acuity of the Study Eye: Average Change From Baseline to Month 1 Through Month 12|Visual acuity was assessed at every study visit for the study eye using best correction determined from protocol refraction. The BCVA measurements were taken in a sitting position using ETDRS–like VA testing charts at a starting distance of 4 meters.|Baseline to Month 12|Analyzed set included all randomized patients who received at least one application of study treatment and had at least one post baseline efficacy assessment. If missing values occurred without a subsequent observed value, the last observed value was carried forward to subsequent scheduled visits by means of a last observation carried forward.||Letters||Standard Deviation|Mean
823409|NCT01171989|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs)|SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.|After the booster dose of the study vaccine up to the study end (from Month 0 to Month 1)|The analysis was performed on the Booster Total Vaccinated Cohort, which included all subjects with the booster vaccine administration documented.||Participants|||Count of Participants
823410|NCT01171989|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE was any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31-day (Days 0-30) post-booster period|The analysis was performed on the Booster Total Vaccinated Cohort, which included all subjects with the booster vaccine administration documented.||Participants|||Count of Participants
823411|NCT01171989|Secondary|Number of Subjects With Any Solicited General Symptoms|Solicited general symptoms assessed included drowsiness, irritability, loss of appetite and fever (defined as axillary temperature ≥ 37.5º C). Any= all reports of the specified symptom irrespective of intensity grade and relationship to vaccination.|During the 8-day (Days 0-7) post-booster period|The analysis was performed on the Booster Total Vaccinated Cohort, which included all subjects with the booster vaccine administration documented and who had the symptoms sheet filled in.||Participants|||Count of Participants
823412|NCT01171989|Secondary|Number of Subjects With Any Solicited Local Symptoms|Solicited local symptoms assessed included pain, redness and swelling. Any= all reports of the speecified symptom irrespective of intensity grade.|During the 8-day (Days 0-7) post-booster period|The analysis was performed on the Booster Total Vaccinated Cohort, which included all subjects with the booster vaccine administration documented and who had the symptoms sheet filled in.||Participants|||Count of Participants
823413|NCT01171989|Secondary|Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations|Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value ≥ 5 EL.U/mL.|At Month 0 and Month 1, before and one month after booster dose|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||EL.U/mL||95% Confidence Interval|Geometric Mean
823414|NCT01171989|Secondary|Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)|A seropositive subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).|At Month 0 and Month 1, before and one month after booster dose|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Participants|||Count of Participants
823415|NCT01171989|Secondary|Anti-poliovirus Types 1, 2 and 3 Antibody Titres|Titers were expressed as geometric mean titters (GMTs) for the seropositivity cut-off value of ≥ 1:8.|At Month 0 and Month 1, before and one month after booster dose|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Titers||95% Confidence Interval|Geometric Mean
823471|NCT01172600|Secondary|Usage of Opioids||2nd block, typically at 1 month from baseline|10 Entonox patients and 11 Oxygen patients did not receive 2nd block.||participants|||Number
823418|NCT01171989|Secondary|Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations ≥ Cut-off Values|The cut-off values assessed were 3.3 milli-international units per milliliter (mIU/mL), 10 mIU/mL and 100 mIU/mL.|At Month 0 and Month 1, before and one month after booster dose|The analysis was performed on the Booster According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Participants|||Count of Participants
823419|NCT01171989|Secondary|Anti-D and Anti-T Antibody Concentrations|Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 0.1 IU/mL.|At Month 0 and Month 1, before and one month after booster dose|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||IU/mL||95% Confidence Interval|Geometric Mean
823420|NCT01171989|Secondary|Number of Seropositive Subjects for Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T)|A seropositive subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).|At Month 0 and Month 1, before and one month after booster dose|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Participants|||Count of Participants
823421|NCT01171989|Secondary|Anti-PSC Antibody Concentrations|Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 0.3 μg/mL.|At Month 0 and Month 1, before and one month after booster dose|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||μg/mL||95% Confidence Interval|Geometric Mean
823422|NCT01171989|Secondary|Number of Subjects With Polysaccharide N. Meningitidis Serogroup C (PSC) Antibody Concentrations ≥ Cut-off Values|The cut-off values assessed were ≥ 0.3 μg/mL and ≥ 2 μg/mL.|At Month 0 and Month 1, before and one month after booster dose|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Participants|||Count of Participants
823423|NCT01171989|Secondary|Anti-rSBA-MenC Antibody Titres|Antibody titers were expressed as geometric mean titers (GMTs) for the seroprotection cut-off value of ≥ 1:8.|At Month 0 and Month 1, before and one month after booster dose|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Titers||95% Confidence Interval|Geometric Mean
823424|NCT01171989|Secondary|Number of Seropositive Subjects for Anti-rSBA-MenC|A seropositive subject for anti-rSBA-MenC was defined as a subject with antibody titers greater than or equal to (≥) 1:128.|At Month 0 and Month 1, before and one month after booster dose|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Participants|||Count of Participants
823425|NCT01171989|Secondary|Number of Seroprotected Subjects Against rSBA-MenC|A seroprotected subject was defined as a subject with anti-rSBA-MenC antibody titers ≥ 1:8.|At Month 0, before the booster dose|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Participants|||Count of Participants
823426|NCT01171989|Secondary|Anti-PRP Antibody Concentrations|Concentrations were expressed as geometric mean concentrations (GMCs) for the cut-off value of ≥ 0.15 μg/mL.|At Month 0 and Month 1, before and one month after booster dose|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||μg/mL||95% Confidence Interval|Geometric Mean
823427|NCT01171989|Secondary|Number of Subjects With Anti-PRP Antibody Concentrations ≥ the Cut-off|The cut-off value of the assay was an anti-PRP antibody concentration ≥ 1 μg/mL.|At Month 0 and Month 1, before and one month after booster dose|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Participants|||Count of Participants
823428|NCT01171989|Secondary|Number of Seropositive Subjects for Anti-PRP|A seropositive subject was defined as a subject with anti-PRP antibody concentrations ≥ 0.15 μg/mL.|At Month 0, before the booster dose|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Participants|||Count of Participants
823429|NCT01171989|Primary|Number of Seroprotected Subjects Against Neisseria Meningitidis Serogroup C Using Baby Rabbit Completent (rSBA-MenC)|A seroprotected subject was defined as a subject with anti-rSBA-MenC titers greater than or equal to (≥) 1:8.|At Month 1, post-booster dose|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Participants|||Count of Participants
823597|NCT01173055|Secondary|Change in fMRI Brain Activation Patterns During Pressure Stimulation From Baseline to Week 9 of Treatment||Week 9||||||
823598|NCT01173055|Secondary|Change in fMRI Brain Activation Patterns During Pressure Stimulation From Baseline to Week 6 of Treatment||Week 6||||||
823430|NCT01171989|Primary|Number of Seroprotected Subjects Against Polyribosyl-Ribitol-Phosphate (PRP)|A seroprotected subject was defined as a subject with anti-PRP antibody concentrations greater than or equal to (≥) 0.15 micrograms per milliliter (μg/mL).|At Month 1, post-booster dose|The analysis was performed on the Booster According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Participants|||Count of Participants
823431|NCT01172145|Secondary|Zarit Burden Inventory|Measure of Caregiver Burden. Caregiver rates each item assessing burden on a 0 to 4 point scale with higher numbers reflecting more frequent occurence of the behavior or feeling being assessed.|after 8 weeks of treatment|||raw score||Standard Deviation|Mean
823432|NCT01172145|Secondary|The Direct Assessment of Functional Status Scale|A direct, examiner observed assessment of basic and instrumental activities of daily living. Participants are awarded points for correct performance of activities. Raw score is used for statistical comparison.|after 8 weeks of treatment|||raw score||Standard Deviation|Mean
823433|NCT01172145|Secondary|Lawton Brody Activities of Daily Living Questionnaire|Caregiver reported performance of personal and instrumental activities of daily living (ADLs. There are 6 personal ADLs (i.e. dressing, grooming, eating, etc) and 8 instrumental ADLs (i.e. managing finances, transportation, food preparation) which are assessed. Each item is awarded 2 points for fully independent, 1 point for minimal or moderate support required, and 0 points for full support. Maximum score for independence with all personal and instrumental ADL's is 28.|after 8 weeks of treatment|||raw score||Standard Deviation|Mean
823434|NCT01172145|Secondary|Zarit Burden Inventory|Measure of Caregiver Burden. Caregiver rates each item assessing burden on a 0 to 4 point scale with higher numbers reflecting more frequent occurence of the behavior or feeling being assessed.|at baseline|||raw score||Standard Deviation|Mean
823435|NCT01172145|Secondary|The Direct Assessment of Functional Status Scale|A direct, examiner observed assessment of basic and instrumental activities of daily living. Participants are awarded points for correct performance of activities. Raw score is used for statistical comparison.|at baseline|||raw score||Standard Deviation|Mean
823436|NCT01172145|Secondary|Lawton Brody Activities of Daily Living Questionnaire|Caregiver reported performance of personal and instrumental activities of daily living (ADLs. There are 6 personal ADLs (i.e. dressing, grooming, eating, etc) and 8 instrumental ADLs (i.e. managing finances, transportation, food preparation) which are assessed. Each item is awarded 2 points for fully independent, 1 point for minimal or moderate support required, and 0 points for full support. Maximum score for independence with all personal and instrumental ADL's is 28.|at baseline|||raw score||Standard Deviation|Mean
823437|NCT01172145|Primary|Apathy|The Frontal Systems Behavior Scale.Raw scores are converted to T-Scores using published norms. T-Scores have a mean of 50 and a standard deviation of 10. T-scores less than or equal to 64 are within the average range. T-scores equal to or greater than 65 are indicative of a clinically significant problem. Higher scores indicate greater problem severity.|after 8 weeks of treatment|||T-score||Standard Deviation|Mean
823438|NCT01172145|Primary|Apathy|The Frontal Systems Behavior Scale. Raw scores are converted to T-Scores using published norms. T-Scores have a mean of 50 and a standard deviation of 10. T-scores less than or equal to 64 are within average range. T-scores equal to or greater than 65 are indicative of a clinically significant problem. Higher scores indicate greater problem severity.|at baseline|||T-score||Standard Deviation|Mean
823439|NCT01172184|Secondary|Number of Participants With Heart Failure Requiring Rehospitalization During Follow-up Period|After discharge from index hospitalization of surgical intervention, heart failure with rehospitalization will be assessed. Heart failure with re-hospitalization was documented by at least one of the following: worse exercise tolerance and respiratory distress with NYHA class III or IV symptoms, presence of pulmonary rales, or chest radiography showing pulmonary congestion, which needed an augmented decongestive regimen during an in-hospital stay. The correlation between left atrial distensibility and heart failure was analyzed. ROC curve was used to estimate the best cut-off point.|1-2 years|||participants|||Number
823440|NCT01172184|Secondary|Number of Participants With Post-operation Atrial Fibrillation|After operation, patients received continuous EKG monitor during the ICU stay. After transfer to ordinary ward, patients received 2 times of EKG record per day and another EKG would be done if patients felt palpitation and irregular heart beats were found by nursing staffs. The event of atrial fibrillation (Af) was defined as irregular irregular heart beats which was lack of p wave and last for more than 30 seconds. The relationship between left atrial distensibility and post-operative Af was analysed. ROC curve was used to assess the best cutoff value of left atrial distensibility.|baseline and 1 year|||participants|||Number
823441|NCT01172184|Primary|Left Ventricular Filling Pressure More Than 15 mmHg Measured by Left Ventricular Catheterization|Since left ventricular filling pressure more than 15 mmHg indicated poor ventricular compliance and more cardiovascular event in many prior reports, the current study used it as the threshold. Otherwise, the correlation between left ventricular filling pressure and left atrial distensibility was assessed. ROC curve was used to estimate the best cut-off point of left atrial distensibility for predicting left ventricular filling pressure more than 15 mmHg.|1 year|Severe mitral regurgitation affects the accuracy of left ventricular filling pressure estimated by tissue Doppler imaging. Therefore, we conducted this study using left atrial parameters to assess left ventricular filling pressure in patients with severe mitral regurgitation.||mmHg||Standard Deviation|Mean
823442|NCT01172288|Secondary|Number of Participants With Adverse Effects|Number of participants with adverse events according to the Pediatric Adverse Events Rating Scale|12 weeks|||participants|||Number
823443|NCT01172288|Secondary|Overall Improvement|Clinical Global Impression - Improvement Scale (CGI-I). The CGI is a 7-point scare that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. 1 = Very much improved; 2 = Much improved; 3 = Minimally improved; 4 = No change; 5 = Minimally worse; 6 = Much worse; 7 = Very much worse.|12 weeks|||units on a scale||Standard Deviation|Mean
823444|NCT01172288|Secondary|Improvement in OCD Severity|Childrens' Yale-Brown Obsessive-Compulsive Scale (CY-BOCS). 10-item scale. Each item is rated from 0-4. A sum total is calculated by adding items 1-10. 0-7: Subclinical. 8-15: Mild. 16-23: Moderate. 24-31: Severe. 32-40: Extreme.|12 weeks|||units on a scale||Standard Deviation|Mean
823445|NCT01172288|Secondary|Improvement of Premonitory Urges|"Premonitory Urge for Tics Scale (PUTS). Items are rated on a scale of 1-4 from least to most. A total score is calculated by summing the scores of all items. Nine is the minimum possible score. A score of 12.5-24.5 indicates medium intensity of premonitory urges for tics. A score of 25-30.5 indicates high intensity which may be associated with marked impairment. Scores 31 and above indicate extremely high intensity with probable severe impairment. A score of 36 is the maximum score possible."|12 weeks|||units on a scale||Standard Deviation|Mean
823446|NCT01172288|Primary|Improvement in Tic Severity|"Yale Global Tic Severity Scale is a standard psychiatric measure that rates tics from 0 (no tics) to 100 (most severe tics).
It separately rates motor tics and vocal tics in 5 subscales (number, frequency, intensity, complexity and interference) where the maximum severity score for motor tics is 25 and for vocal tics is 25. Giving us the Total Tic Severity Score maximum of 50.
The additional Impairment Scale rates the degree of disability caused by the tics ranging from 0 (none) to 50 (severe). When these two scores are added we get the Yale Global Tic Severity Scale Score."|12 weeks|||units on a scale||Standard Deviation|Mean
823447|NCT01172353|Secondary|Dialysis During Hospitalization||During hospitalization|||participants|||Number
823448|NCT01172353|Primary|Contrast-induced Nephropathy|rise in serum creatinine >0,5mg/dl|48 hours|||percentage of contrast nephropaty|||Number
823449|NCT01172418|Secondary|Patient Survival||at 3 years post-transplant||||||
823450|NCT01172418|Secondary|Patient Survival||at 1 year post-transplant||||||
823451|NCT01172418|Secondary|Graft Survival||at 3 years post-transplant||||||
823452|NCT01172418|Secondary|Graft Survival||at 1 year post-transplant||||||
823453|NCT01172418|Primary|Incidence of Acute Rejection at One Year Post-transplant||at one year post-transplant|||percentage of patients having BPAR|||Number
823454|NCT01172522|Primary|Number of Participants Who Showed Improvement in Under Eye Swelling and Dark Circles Relative to Baseline Per Intervention|Efficacy was measured per intervention by assessing number of participants with improvement in under eye dark circles and swelling. Criteria used to assess under eye improvement and swelling was by a 5 point scale comparing each week's photographic appearance to the appearance at baseline: 1) fexofenadine right and placebo left, and 2) fexofenadine left and placebo right. The split face comparison was noted in efficacy measured changes in under eye swelling and dark circles relative to baseline. Participants were graded by 2 blinded dermatologists who reviewed photographs of all participants at entry and weekly until end of study plus one week, day 37. Total number of participants: 30. Placebo right and fexofenadine left 15 participants. Placebo left and fexofenadine right 15 participants.|Baseline, weekly, and end of study +7 days|Thirty participants in total; 15 had fexofenadine left and placebo right; 15 had fexofenadine right and placebo left.||participants|||Number
823455|NCT01172535|Primary|Proportion of Participants Tolerating LPV/r|Participants were considered to have tolerated medication if they did not stop treatment before the 24 week PK visit for any reason other than completing treatment or death not related to treatment.|Measured at study completion (week 24)|All participants||proportion of participants||95% Confidence Interval|Number
823456|NCT01172535|Primary|Number of Participants Experiencing Adverse Events of Grade 3 or 4|Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009, which is available on the RSC web site (http://rsc.tech-res.com/safetyandpharmacovigilance/). Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening, Grade 5 = death|Measured at study visits through end of study (weeks 2, 4, 12, 24)|All participants||participants|||Number
823457|NCT01172535|Secondary|Treatment Efficacy (CD4%)|Having CD4%≥25 at the week 24 visit.|Measured at entry and study completion (week 24)|Participants with data from both study entry and the week 24 study visit||proportion of participants||95% Confidence Interval|Number
823458|NCT01172535|Secondary|Treatment Efficacy (HIV Viral Load)|Having HIV viral load <400 copies/mL at the week 24 visit|Measured at entry and study completion (week 24)|Participants with data from both study entry and the week 24 study visit||proportion of participants||95% Confidence Interval|Number
823459|NCT01172535|Secondary|Adherence|Adherence, defined as proportion of doses taken (note: proportion could be greater than 1.0 for reasons such as tablets having to be taken twice due to first one being spit out or imprecise measurement of liquid doses)|Measured at week 4, week 12, and study completion (week 24)|Participants bringing medication to be measured at the study visit||Proportion of expected doses taken||Inter-Quartile Range|Median
823460|NCT01172535|Primary|Proportion of Participants With an AUC of Less Than 10% of Adults|Proportion of participants with an AUC less that 10% of adults (AUC0-24 <104 mcg*hr/mL)|Measured at 4 weeks of treatment prior to the observed dose and at 2, 4, 6, 8, and 12 hours post-dose|Participants with complete pharmacokinetics data at week 4||proportion of participants||90% Confidence Interval|Number
823461|NCT01172535|Primary|Clearance of Lopinavir/Ritonavir (CL/F)|Clearance of lopinavir/ritonavir, as determined by analysis of 12-hour pharmacokinetic sampling|Measured at 4 weeks of treatment prior to the observed dose and at 2, 4, 6, 8, and 12 hours post-dose|Participants having complete pharmacokinetics data at week 4||L/h/kg||90% Confidence Interval|Geometric Mean
823462|NCT01172535|Primary|Minimum Concentration of Lopinavir/Ritonavir (Cmin)|Minimum concentration of lopinavir/ritonavir, as determined by analysis of 12-hour pharmacokinetic sampling|Measured at 4 weeks of treatment prior to the observed dose and at 2, 4, 6, 8, and 12 hours post-dose|Participants having complete pharmacokinetics data at week 4||mcg/mL||90% Confidence Interval|Geometric Mean
823463|NCT01172535|Primary|Maximum Concentration of Lopinavir/Ritonavir (Cmax)|Maximum concentration of lopinavir/ritonavir, as determined by analysis of 12-hour pharmacokinetic sampling|Measured at 4 weeks of treatment prior to the observed dose and at 2, 4, 6, 8, and 12 hours post-dose|Participants having complete pharmacokinetics data at week 4||mcg/mL||90% Confidence Interval|Geometric Mean
823464|NCT01172535|Primary|Lopinovir/Ritonavir Area Under the Concentration-time Curve (AUC0-24)|Area under the curve over 24 hours (AUC0-24), as determined by a non-compartmental analysis of 12-hour pharmacokinetic sampling for lopinavir/ritonavir|Measured at 4 weeks of treatment prior to the observed dose and at 2, 4, 6, 8, and 12 hours post-dose|Participants having complete pharmacokinetics data at week 4||mcg*hr/mL||90% Confidence Interval|Geometric Mean
823465|NCT01172600|Secondary|Biomarkers|BIOMARKERS: IL-1β, IL-6, IL-10, 1L-17A, IFN-γ, and TNF-α|3 months follow-up after last block (maximum of 3 blocks with a typical 1 month interval between blocks)|No blood sample was planned to be collected.|||||
823472|NCT01172600|Secondary|Change in Oswestry Score (% of Disability) From Baseline to 3 Months Follow-up|Oswestry score ranges from 0% to 100%, which measures % of disability. The outcome is change in the Oswestry score from baseline (before 1st block) to 3 months follow-up.|At baseline (before 1st block) and 3 months follow-up after last block (maximum of 3 blocks with a typical 1 month interval between blocks)|5 patients in each group were lost follow-up.||absolute percentage||Standard Deviation|Mean
823473|NCT01172600|Secondary|Change in Oswestry Score (% of Disability) From Baseline to 3rd Block|Oswestry score ranges from 0% to 100%, which measures % of disability. The outcome is change in the Oswestry score from baseline (before 1st block) to before 3rd block.|At baseline (before 1st block) and before the 3rd block, typically at 2 months from baseline|21 Entonox patients and 26 Oxygen patients did not receive 3rd block.||absolute percentage||Standard Deviation|Mean
823474|NCT01172600|Secondary|Change in Oswestry Score (% of Disability) From Baseline to 2nd Block|Oswestry score ranges from 0% to 100%, which measures % of disability. The outcome is change in the Oswestry score from baseline (before 1st block) to before 2nd block.|At baseline (before 1st block) and before the 2nd block, typically at 1 month from baseline|10 Entonox patients and 11 Oxygen patients did not receive 2nd block.||absolute percentage||Standard Deviation|Mean
823475|NCT01172600|Primary|Change in VAS Pain Score From Baseline to Before 3rd Block|"10-cm-long Visual Analog Scale (VAS) pain score, ranges from 0 (no pain) to 10 (worst pain imaginable). It was measured before 1st 2nd and 3rd block and at 3 month follow-up.
The primary outcome was the change in VAS pain score from baseline (before 1st block) to before the 3rd block"|At baseline (before 1st block) and before the 3rd block, typically at 2 months from baseline|21 patients in the Entonox group and 26 patients in the Oxygen group did not receive the 2nd block treatment||units on a scale||Standard Deviation|Mean
823476|NCT01172600|Primary|Change in VAS Pain Score From Baseline to Before 2nd Block|"10-cm-long Visual Analog Scale (VAS) pain score, ranges from 0 (no pain) to 10 (worst pain imaginable). It was measured before 1st 2nd and 3rd block and at 3 month follow-up.
The primary outcome was the change in VAS pain score from baseline (before 1st block) to before the 2nd block."|At baseline (before 1st block) and before the 2nd block, typically at 1 month from baseline|10 patients in the Entonox group and 11 patients in the Oxygen group did not receive the 2nd block treatment||units on a scale||Standard Deviation|Mean
823477|NCT01172600|Primary|Change in VAS Pain Score From Baseline to 3 Month Follow-up|"10-cm-long Visual Analog Scale (VAS) pain score, ranges from 0 (no pain) to 10 (worst pain imaginable). It was measured before 1st 2nd and 3rd block and at 3 month follow-up.
The primary outcome was the change in VAS pain score from baseline (before 1st block) to the 3 month follow-up."|At baseline (before 1st block) and 3 months follow-up after last block (maximum of 3 blocks with a typical 1 month interval between blocks)|For 10 patients with missing VAS at 3 month follow up: 5 patients who had 2nd or 3rd epidural block, we assigned the last VAS observation (i.e., from VAS before 2nd or 3rd block to 3 month follow-up); and for 5 patients who only had 1st epidural, we assigned the worst VAS (10) for Entonox patients and the best VAS (0) for Oxygen patients.||units on a scale||Standard Deviation|Mean
823478|NCT01172808|Secondary|Time to First Asthma Exacerbation From the Two Twin Trials 205.419 (NCT01172821) and the Present 205.418 (NCT01172808)|Time to first asthma exacerbation (including severe, non-severe; symptomatic, asymptomatic; i.e. any exacerbation) during the 24-week treatment period on combined data from the two twin trials 205.418 (NCT01172808) and 205.419 (NCT01172821)|24 weeks|FAS of combined data from the two twin trials 205.419 (NCT01172821) and 205.418 (NCT01172808)||weeks||95% Confidence Interval|Median
823479|NCT01172808|Secondary|Time to First Severe Asthma Exacerbation From the Two Twin Trials 205.419 (NCT01172821) and the Present 205.418 (NCT01172808)|Time to first severe asthma exacerbation during the 24-week treatment period on combined data from the two twin trials 205.418 (NCT01172808) and 205.419 (NCT01172821).|24 weeks|FAS of combined data from the two twin trials 205.419 (NCT01172821) and 205.418 (NCT01172808)||weeks||95% Confidence Interval|Median
823480|NCT01172808|Primary|The Responder Rate as Assessed by the ACQ From the Two Twin Trials 205.419 (NCT01172821) and the Present 205.418 (NCT01172808)|"The responder rate as assessed by the Asthma Control Questionnaire (ACQ) determined at the end of the 24-week treatment period (on combined data from the two twin trials 205.418 (NCT01172808) and 205.419 (NCT01172821)). A patient was considered to be a responder if he or she was reported with an improvement (decrease) in the ACQ total score of at least 0.5 points.
The ACQ total score was calculated as the mean of the responses to 7 questions and was analysed as an absolute value. The score ranges from 0 (no impairment) to 6 (maximum impairment)."|24 weeks|FAS of combined data from the two twin trials 205.419 (NCT01172821) and 205.418 (NCT01172808)||Percentage of participants|||Number
823481|NCT01172808|Secondary|Asthma Symptom-free Days Based on the Weekly Mean Response at Week 24|Weekly means obtained during the last 7 days before week 24 measured by patients at home using the AM3 device. Response was defined as change from baseline. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week. An asthma symptom-free day was defined as a day with no reported symptoms and no use of rescue medication.|Baseline and last 7 days before week 24 visit|FAS||Days||Standard Error|Mean
823482|NCT01172808|Secondary|Mean Number of Puffs of Rescue Medication During the Entire 24-h Day Based on the Weekly Mean Response at Week 24|Daily use of salbutamol (albuterol) rescue medication as needed during the entire study period. Weekly means obtained during the last 7 days before week 24 measured by patients at home using the AM3 device. Response was defined as change from baseline. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week.|Baseline and last 7 days before week 24 visit|FAS||Number of Puffs||Standard Error|Mean
823483|NCT01172808|Secondary|Mean Pre-dose Evening FEV1 (FEV1 p.m.) Based on the Weekly Mean Response at Week 24|Weekly means obtained during the last 7 days before week 24 measured by patients at home using the AM3 device. Response was defined as change from baseline. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week.|Baseline and last 7 days before week 24 visit|FAS||Litre||Standard Error|Mean
823484|NCT01172808|Secondary|Mean Pre-dose Morning FEV1 (FEV1 a.m.) Based on the Weekly Mean Response at Week 24|Weekly means obtained during the last 7 days before week 24 measured by patients at home using the AM3 device. Response was defined as change from baseline. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week.|Baseline and last 7 days before week 24 visit|FAS||Litre||Standard Error|Mean
823599|NCT01173055|Secondary|Change in fMRI Brain Activation Patterns During Pressure Stimulation From Baseline to End of Treatment||Week 0 to Week 15||||||
823485|NCT01172808|Secondary|PEF Variability|PEF daily variability was assesed by patients at home using the AM3 device. PEF variability is the absolute difference between morning and evening PEF value divided by their mean, based on the weekly mean response at week 24. Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.|Last 7 days before week 24 visit|FAS||Percentage of mean PEF||Standard Error|Mean
823486|NCT01172808|Secondary|Mean Pre-dose Evening PEF (PEF p.m.) Based on the Weekly Mean Response at Week 24|Weekly means obtained during the last 7 days before week 24 measured by patients at home using the AM3 device. Response was defined as change from baseline. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week.|Baseline and last 7 days before week 24 visit|FAS||Litre/min||Standard Error|Mean
823487|NCT01172808|Secondary|Mean Pre-dose Morning PEF (PEF a.m.) Based on the Weekly Mean Response at Week 24|Weekly means obtained during the last 7 days before week 24 measured by patients at home using the AM3 device. Response was defined as change from baseline. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week.|Baseline and last 7 days before week 24 visit|FAS||Litre/min||Standard Error|Mean
823488|NCT01172808|Secondary|The Responder Rate as Assessed by the ACQ|The responder rate as assessed by the Asthma Control Questionnaire (ACQ) determined at the end of the 24-week treatment period. A patient was considered to be a responder if he or she was reported with an improvement (decrease) in ACQ total score of at least 0.5 points. The ACQ total score was calculated as the mean of the responses to 7 questions and was analysed as an absolute value. The score ranges from 0 (no impairment) to 6 (maximum impairment).|24 weeks|FAS||Percentage of Participants|||Number
823489|NCT01172808|Secondary|Total Asthma Control Questionnaire (ACQ) Score at the End of the 24-week Treatment Period|Control of asthma as assessed by the ACQ determined at the end of 24-week treatment. The ACQ contains 7 questions, each question has a 7 point scale from 0 (no symptoms) till 6 (highest intensity). Total score was defined as the sum of all items divided by the number of items. Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.|24 weeks|FAS||units on a scale||Standard Error|Mean
823490|NCT01172808|Secondary|Total Asthma Quality of Life Questionnaire (AQLQs)) Score|Total score from the Standardised Asthma Quality of Life Questionnaire (AQLQ(s)) determined at the end of 24-week treatment. The AQLQ(s) contains 32 questions, each question has a 7 point scale from 1 (highest intensity) till 7 (no symptoms). Total score was defined as the sum of all items divided by the number of items. Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.|24 weeks|FAS||units on a scale||Standard Error|Mean
823491|NCT01172808|Secondary|Trough PEF Response|Trough peak expiratory flow (PEF) response determined at the end of the 24-week treatment. Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2). Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.|24 weeks|FAS||Litre/min||Standard Error|Mean
823492|NCT01172808|Secondary|FVC Area Under Curve 0-3 Hours (AUC0-3h) Response|Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2) determined at the end of the 24-week treatment. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|24 weeks|FAS||Litre||Standard Error|Mean
823493|NCT01172808|Secondary|FEV1 Area Under Curve 0-3 Hours (AUC0-3h) Response|Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2) determined at the end of the 24-week treatment. Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|24 weeks|FAS||Litre||Standard Error|Mean
823494|NCT01172808|Secondary|Trough FVC Response|Trough FVC response determined at the end of the 24-week treatment. Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2). Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week.|24 weeks|FAS||Litre||Standard Error|Mean
823495|NCT01172808|Secondary|Peak FVC Within 3 Hours Post-dose Response|Peak forced vital capacity (FVC) response within 3 hours post-dose determined at the end of the 24-week treatment. Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2). Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.|24 weeks|FAS||Litre||Standard Error|Mean
823496|NCT01172808|Primary|Trough FEV1 Response|Trough FEV1 response determined at the end of the 24-week treatment. Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2). Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.|24 weeks|FAS||Litre||Standard Error|Mean
823497|NCT01172808|Primary|Peak FEV1 Within 3 Hours Post-dose Response|Peak forced expiratory volume in one second (FEV1) response within 3 hours post-dose determined at the end of the 24-week treatment. Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2). Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.|24 weeks|Full Analysis Set (FAS) - all treated patients who had baseline data and at least 1 on-treatment efficacy measurement excluding patients from one centre due to non-compliance with good clinical practice.||Litre||Standard Error|Mean
823498|NCT01172821|Secondary|Time to First Asthma Exacerbation From the Two Twin Trials 205.418 (NCT01172808) and the Present 205.419 (NCT01172821)|Time to first asthma exacerbation (including severe, non-severe; symptomatic, asymptomatic; i.e. any exacerbation) during the 24-week treatment period on combined data from the two twin trials 205.418 (NCT01172808) and 205.419 (NCT01172821)|24 weeks|FAS of combined data from the two twin trials 205.418 (NCT01172808) and 205.419 (NCT01172821)||weeks||95% Confidence Interval|Median
823499|NCT01172821|Secondary|Time to First Severe Asthma Exacerbation From the Two Twin Trials 205.418 (NCT01172808) and the Present 205.419 (NCT01172821)|Time to first severe asthma exacerbation during the 24-week treatment period on combined data from the two twin trials 205.418 (NCT01172808) and 205.419 (NCT01172821)|24 weeks|FAS of combined data from the two twin trials 205.418 (NCT01172808) and 205.419 (NCT01172821)||weeks||95% Confidence Interval|Median
825989|NCT01195090|Secondary|Changes in Fasting Plasma Glucose|fasting serum sugar change from baseline to 24 weeks|24 weeks|An intent-to-treat (ITT) analysis with last observation carried forward was used to assess efficacy.||mg/dl||Standard Error|Least Squares Mean
823500|NCT01172821|Primary|The Responder Rate as Assessed by the ACQ From the Two Twin Trials 205.418 (NCT01172808) and the Present 205.419 (NCT01172821)|The responder rate as assessed by the Asthma Control Questionnaire (ACQ) determined at the end of the 24-week treatment period (on combined data from the two twin trials 205.418 (NCT01172808) and 205.419 (NCT01172821)). A patient was considered to be a responder if he or she was reported with an improvement (decrease) in the ACQ total score of at least 0.5 points.|24 weeks|FAS of combined data from the two twin trials 205.418 (NCT01172808) and 205.419 (NCT01172821).||Percentage of participants|||Number
823501|NCT01172821|Secondary|Asthma Symptom-free Days Based on the Weekly Mean Response at Week 24|Weekly means obtained during the last 7 days before week 24 measured by patients at home using the AM3 device. Response was defined as change from baseline. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week. An asthma symptom-free day was defined as a day with no reported symptoms and no use of rescue medication.|Baseline and last 7 days before week 24 visit|FAS||Days||Standard Error|Mean
823502|NCT01172821|Secondary|Mean Number of Puffs of Rescue Medication During the Entire 24-h Day Based on the Weekly Mean Response at Week 24|Daily use of salbutamol (albuterol) rescue medication as needed during the entire study period. Weekly means obtained during the last 7 days before week 24 measured by patients at home using the AM3 device. Response was defined as change from baseline. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week.|Baseline and last 7 days before week 24 visit|FAS||Number of Puffs||Standard Error|Mean
823503|NCT01172821|Secondary|Mean Pre-dose Evening FEV1 (FEV1 p.m.) Based on the Weekly Mean Response at Week 24|Weekly means obtained during the last 7 days before week 24 measured by patients at home using the AM3 device. Response was defined as change from baseline. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week.|Baseline and last 7 days before week 24 visit|FAS||Litre||Standard Error|Mean
823504|NCT01172821|Secondary|Mean Pre-dose Morning FEV1 (FEV1 a.m.) Based on the Weekly Mean Response at Week 24|Weekly means obtained during the last 7 days before week 24 measured by patients at home using the AM3 device. Response was defined as change from baseline. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week.|Baseline and last 7 days before week 24 visit|FAS||Litre||Standard Error|Mean
823505|NCT01172821|Secondary|PEF Variability|PEF daily variability was assesed by patients at home using the AM3 device. PEF variability is the absolute difference between morning and evening PEF value divided by their mean, based on the weekly mean response at week 24. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week.|Last 7 days before week 24 visit|FAS||Percentage of Mean PEF||Standard Error|Mean
823506|NCT01172821|Secondary|Mean Pre-dose Evening PEF (PEF p.m.) Based on the Weekly Mean Response at Week 24|Weekly means obtained during the last 7 days before week 24 measured by patients at home using the AM3 device. Response was defined as change from baseline. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week.|Baseline and last 7 days before week 24 visit|FAS||Litre/min||Standard Error|Mean
823507|NCT01172821|Secondary|Mean Pre-dose Morning PEF (PEF a.m.) Based on the Weekly Mean Response at Week 24|Weekly means obtained during the last 7 days before week 24 measured by patients at home using the AM3 device. Response was defined as change from baseline. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week|Baseline and last 7 days before week 24 visit|FAS||Litre/min||Standard Error|Mean
823508|NCT01172821|Secondary|The Responder Rate as Assessed by the ACQ|The responder rate as assessed by the Asthma Control Questionnaire (ACQ) determined at the end of the 24-week treatment period. A patient was considered to be a responder if he or she was reported with an improvement (decrease) in ACQ total score of at least 0.5 points.The score ranges from 0 (no impairment) to 6 (maximum impairment).|24 weeks|FAS||Percentage of participants|||Number
823509|NCT01172821|Secondary|Total Asthma Control Questionnaire (ACQ) Score|Control of asthma as assessed by the ACQ determined at the end of 24-week treatment. The ACQ contains 7 questions, each question has a 7 point scale from 0 (no symptoms) till 6 (highest intensity). Total score was defined as the sum of all items divided by the number of items and ranges from from 0 (no symptoms) till 6 (highest intensity). Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.|24 weeks|FAS||units on a scale||Standard Error|Mean
823510|NCT01172821|Secondary|Total Asthma Quality of Life Questionnaire (AQLQs)) Score|"Total score from the Standardised Asthma Quality of Life Questionnaire (AQLQ(s)) determined at the end of 24-week treatment.
The AQLQ(s) contains 32 questions, each question has a 7 point scale from 1 (highest intensity) till 7 (no symptoms). Total score was defined as the sum of all items divided by the number of items and ranges from from 1 (highest intensity) till 7 (no symptoms). Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week."|24 weeks|FAS||units on a scale||Standard Error|Mean
823511|NCT01172821|Secondary|Trough PEF Response|Trough peak expiratory flow (PEF) response determined at the end of the 24-week treatment. Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2). Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.|24 weeks|FAS||Litre/min||Standard Error|Mean
823512|NCT01172821|Secondary|FVC Area Under Curve 0-3 Hours (AUC0-3h) Response|Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2) determined at the end of the 24- week treatment. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|24 weeks|FAS||Litre||Standard Error|Mean
823513|NCT01172821|Secondary|FEV1 Area Under Curve 0-3 Hours (AUC0-3h) Response|Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2) determined at the end of the 24- week treatment. Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|24 weeks|FAS||Litre||Standard Error|Mean
823514|NCT01172821|Secondary|Trough FVC Response|Trough FVC response determined at the end of the 24-week treatment. Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2). Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week.|24 weeks|FAS||Litre||Standard Error|Mean
823515|NCT01172821|Secondary|Peak FVC Within 3 Hours Post-dose Response|Peak forced vital capacity (FVC) response within 3 hours post-dose determined at the end of the 24-week treatment. Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2). Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.|24 weeks|FAS||Litre||Standard Error|Mean
823516|NCT01172821|Primary|Trough FEV1 Response|Trough FEV1 response determined at the end of the 24-week treatment. Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2). Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.|24 weeks|FAS||Litre||Standard Error|Mean
823517|NCT01172821|Primary|Peak FEV1 Within 3 Hours Post-dose Response|Peak forced expiratory volume in one second (FEV1) response within 3 hours post-dose determined at the end of the 24-week treatment. Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2). Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.|24 weeks|Full Analysis Set (FAS) - all treated patients who had baseline data and at least 1 on-treatment efficacy measurement.||Litre||Standard Error|Mean
823518|NCT01172847|Secondary|Number of Participants With Clinically Significant or Treatment Related Changes in Electrocardiogram (ECG)|ECG was recorded when participants were rested in a supine position for at least 5 minutes.|Screening; pre-dose on Day 1 and Day 5 of each treatment period; Follow-up visit|Safety Population included all participants who received at least one dose of the study medication, whether prematurely withdrawn from the study or not.||participants|||Number
823519|NCT01172847|Secondary|Number of Participants With Marked Abnormality in Laboratory Parameters|"Laboratory analysis included hematology (hemoglobin, hematocrit, erythrocytes, platelets counts, leukocytes counts, neutrophils, eosinophils, lymphocytes, basophils, and monocytes);, biochemistry (aspartate aminotransferase , alanine aminotransferase, gamma glutamyl trans peptidase, total bilirubin, alkaline phosphatase, lactate dehydrogenase, albumin, creatinine, urea, creatine phosphokinase, total protein, sodium, chloride, calcium, phosphate, potassium, glucose (fasting), amylase, lipase, total cholesterol, and calculated creatinine clearance); and urinalysis.
Marked laboratory test values (high and low) falling outside the marked reference range and which also represents a clinically relevant change from baseline of at least a designated amount were recoded. In this study, marked abnormality ranges for phosphate as 0.75 – 1.60 millimole (mmol)/L and proteinuria (0 to 4+, and 1)."|Screening; Day -1 and Day 5 (pre-dose) of each treatment period; Follow-up visit|Safety Population included all participants who received at least one dose of the study medication, whether prematurely withdrawn from the study or not.||participants|||Number
823520|NCT01172847|Secondary|Number of Participants With Abnormal Vital Signs|Vital signs included heart rate (HR), blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]), and body temperature. Blood pressure and pulse rate were recorded when participants were rested in a supine position for at least 5 minutes and after standing for 2 minutes. Vital signs values that fall outside the investigator’s normal ranges were recorded.|Screening (Days -28 to -2); pre-dose and 2h post-dose on D1 and D5 of each treatment period; at Follow-up visit (10 -14 days after last dose) for blood pressure and HR; Screening; Day -1 of each treatment period; Follow-up visit for temperature|Safety Population included all participants who received at least one dose of the study medication, whether prematurely withdrawn from the study or not.||participants|||Number
823521|NCT01172847|Secondary|Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.|Up to 11 weeks|Safety Population included all participants who received at least one dose of the study medication, whether prematurely withdrawn from the study or not.||participants|||Number
823522|NCT01172847|Secondary|Maximum Plasma Concentration (Cmax) of Rimantadine|Cmax of rimantadine was calculated following the administration of rimantadine alone or in combination with oseltamivir and was directly observed from the data.|Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours post-dose on Day 5|PK analysis population included all participants who were adhered to the protocol.||ng/mL||90% Confidence Interval|Least Squares Mean
823523|NCT01172847|Secondary|Maximum Plasma Concentration (Cmax) of Oseltamivir and Oseltamivir Carboxylate|Oseltamivir carboxylate is active metabolite of oseltamivir. Cmax of oseltamivir and oseltamivir carboxylate were calculated following the administration of oseltamivir alone or in combination with rimantadine and was directly observed from the data.|Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours post-dose on Day 5|PK analysis population included all participants who were adhered to the protocol.||ng/mL||90% Confidence Interval|Least Squares Mean
823524|NCT01172847|Primary|Steady State Area Under the Plasma Concentration Versus Time Curve From 0 to 12 Hours After Dosing (AUC0-12) of Rimantadine|AUC0-12 of rimantadine was calculated following the administration of rimantadine alone or in combination with oseltamivir, using the linear trapezoidal rule.|Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours post-dose on Day 5|Pharmacokinetic analysis population included all participants who were adhered to the protocol.||h*ng/mL||90% Confidence Interval|Least Squares Mean
823525|NCT01172847|Primary|Steady State Area Under the Plasma Concentration Versus Time Curve From 0 to 12 Hours After Dosing (AUC0-12) of Oseltamivir and Oseltamivir Carboxylate|Oseltamivir carboxylate is active metabolite of oseltamivir. AUC0-12 of oseltamivir and oseltamivir carboxylate were calculated following the administration of oseltamivir alone or in combination with rimantadine, using the linear trapezoidal rule.|Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours post-dose on Day 5|Pharmacokinetics (PK) analysis population included all participants who were adhered to the protocol.||hours (h)*nanogram (ng)/milliliter (mL)||90% Confidence Interval|Least Squares Mean
823526|NCT01166126|Secondary|Number of Participants With Related Serious Adverse Events (SAEs)|Toxicities assessed using NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v4.0.|1 year|||participants|||Number
823600|NCT01173055|Secondary|Change in Pain Tolerance From Baseline to End of Treatment|The primary outcome parameter is the change in pressure pain tolerance (maximum tolerated pressure) from baseline to end of treatment. Measured in kg/cm^2. Lower values represent a worse outcome.|Week 0 -Week 15|||kg/cm^2||Standard Deviation|Mean
823527|NCT01166126|Secondary|Number of Participants With Progression Free Survival (PFS) at 6 Months.|"Patients will be evaluated by physical examination and imaging assessments (brain MRI and CT scans of the chest, abdomen and pelvis). Disease progression will be defined by RECIST criteria on physical exam or diagnostic imaging assessments that are attributed to metastatic melanoma.
Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression)."|6 months from day 1 of treatment|||participants|||Number
823528|NCT01166126|Primary|Number of Participants With Overall Survival (OS) at One Year|The one-year overall survival of the combination of temsirolimus and AZD6244 Hydrogen Sulfate.|1 year post last treatment|||participants|||Number
823529|NCT01166126|Primary|Number of Participants With Complete Response (CR) and Partial Response (PR)|"Anti-tumor response (CR+PR) was defined by Response Evaluation Criteria in Solid Tumors (RECIST).
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters."|1 year|All participants||participants|||Number
823530|NCT01172873|Secondary|Beck Depression Inventory (BDI)|Beck’s Depression Inventory (BDI): This is a 21-item self report that measures depression symptoms and will be used for both adults and adolescents at baseline, session 5, session 10 and the follow-up visit. BDI-II scores range from 0-63, with higher scores representing greater severity of depression symptoms.|baseline, visit 5, visit 10, follow-up visit|Data from 14 adolescents were analyzed. One participant was excluded from analyses because he did not receive DCS at every treatment visit. Another was excluded because she was unable to provide reliable data on outcome measures. Another was excluded because she was unable to provide reliable data on outcome measures.||units on a scale||Standard Deviation|Mean
823531|NCT01172873|Secondary|Multidimensional Anxiety Scale for Children (MASC)|Multidimensional Anxiety Scale for Children (MASC): This is a 39-item self-report that measures anxiety symptoms. It provides a total score, as well as 10 subscales, although only total scores will be analyzed. MASC scores range from 0-117, with higher scores representing greater severity of anxiety symptoms. The MASC and will be administered at baseline, session 5, session 10 and the follow-up visit for adolescents.|baseline, visit 5, visit 10, follow-up visit|Data from 14 adolescents were analyzed. One participant was excluded from analyses because he did not receive DCS at every treatment visit. Another was excluded because she was unable to provide reliable data on outcome measures.||units on a scale||Standard Deviation|Mean
823532|NCT01172873|Primary|Child Yale-Brown Obsessive Compulsive Scale (CY-BOCS) for Adolescents|The CYBOCS is a semi-structured measure of Obsessive Compulsive Disorder (OCD) severity with excellent inter-rater reliability, internal consistency, and test-retest reliability. It is validated in those starting at age 7 and used in studies up to age 20.The CYBOCS differs from the adult Yale-Brown Obsessive Compulsive Scale (YBOCS) only in its use of simpler language. CYBOCS scores range from 0-40, with higher scores representing greater severity of symptoms. The CYBOCS will be administered by independent evaluators (IEs) at baseline, session 5, session 10 and the follow-up visit. It will be the primary outcome measure. The CYBOCS checklist will be used to determine symptom dimensions.|baseline, visit 5, visit 10, follow-up visit|Data from 14 adolescents were analyzed. One participant was excluded from analyses because he did not receive DCS at every treatment visit. Another was excluded because she was unable to provide reliable data on outcome measures.||units on a scale||Standard Deviation|Mean
823533|NCT01172938|Secondary|Number of Participants With Adverse Events||Up to 5 years||10/2017||||
823534|NCT01172938|Secondary|Percentage of Participants Achieving a Dactylitis Score of Zero at Week 52|"Percentage of participants with pre-existing dactylitis whose dactylitis severity score improves to zero after 52 weeks.
Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.
Two-sided 95% confidence interval is based on the Clopper-Pearson method."|Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; Participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) and who had sufficient data for a definitive determination of response status at Week 52 are included.||percentage of participants||95% Confidence Interval|Number
823535|NCT01172938|Secondary|Percentage of Participants Achieving a MASES Score of Zero at Week 52|"Percentage of participants with pre-existing enthesopathy whose MASES improves to 0 after 24 weeks. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):
1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right.
The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.
Two-sided 95% confidence interval is based on the Clopper-Pearson method."|Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants with a baseline value > 0 (i.e., pre-existing enthesopathy) and who had sufficient data for a definitive determination of response status at Week 52 are included.||percentage of participants||95% Confidence Interval|Number
823536|NCT01172938|Secondary|Percentage of Participants With an ACR 70 Response at Week 52|"Percentage of participants with an American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:
≥ 70% improvement in 78 tender joint count;
≥ 70% improvement in 76 swollen joint count; and
≥ 70% improvement in at least 3 of the 5 following parameters:
Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
Patient's global assessment of disease activity (measured on a 100 mm VAS);
Physician's global assessment of disease activity (measured on a 100 mm VAS);
Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));
C-Reactive Protein.
Two-sided 95% confidence interval is based on the Clopper-Pearson method."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.||percentage of participants||95% Confidence Interval|Number
823537|NCT01172938|Secondary|Percentage of Participants With an ACR 50 Response at Week 52|"Percentage of participants with an American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:
≥ 50% improvement in 78 tender joint count;
≥ 50% improvement in 76 swollen joint count; and
≥ 50% improvement in at least 3 of the 5 following parameters:
Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
Patient's global assessment of disease activity (measured on a 100 mm VAS);
Physician's global assessment of disease activity (measured on a 100 mm VAS);
Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));
C-Reactive Protein.
Two-sided 95% confidence interval is based on the Clopper-Pearson method."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.||percentage of participants||95% Confidence Interval|Number
823538|NCT01172938|Secondary|Percentage of Participants Achieving Good or Moderate EULAR Response at Week 52|"A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score.
A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 3.2.
A Moderate Response is defined as either:
an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 score of less than or equal to 5.1 or,
an improvement (decrease) in the DAS28 of more than 1.2 and attainment of a DAS28 score of greater than 3.2."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.||percentage of participants|||Number
823539|NCT01172938|Secondary|Percentage of Participants With Dactylitis Improvement ≥ 1 Point at Week 52|"Percentage of participants with pre-existing dactylitis whose dactylitis severity score improved by ≥ 1 after 52 weeks.
Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.
Two-sided 95% confidence interval is based on the Clopper-Pearson method."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; Participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) and who had sufficient data for a definitive determination of response status at Week 52 are included.||percentage of participants||95% Confidence Interval|Number
823540|NCT01172938|Secondary|Percentage of Participants With MASES Improvement ≥ 20% at Week 52|"Percentage of participants with pre-existing enthesopathy whose MASES improved by ≥ 20% from Baseline after 52 weeks. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):
1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right.
The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.
Two-sided 95% confidence interval is based on the Clopper-Pearson method."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) and who had sufficient data for a definitive determination of response status at Week 52 are included.||percentage of participants||95% Confidence Interval|Number
823541|NCT01172938|Secondary|Change From Baseline in the FACIT-Fatigue Scale Score at Week 52|"The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue. A positive change from Baseline score indicates an improvement."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.||units on a scale||Standard Deviation|Mean
823542|NCT01172938|Secondary|Change From Baseline in the DAS28 at Week 52|"The DAS28 measures the severity of disease at a specific time and is derived from the following variables:
28 tender joint count
28 swollen joint count, which do not include the DIP joints, the hip joint, or the joints below the knee;
C-reactive protein (CRP)
Patient's global assessment of disease activity.
DAS28(CRP) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.||units on a scale||Standard Deviation|Mean
823543|NCT01172938|Secondary|Change From Baseline in the CDAI Score at Week 52|"The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:
28 tender joint count (TJC),
28 swollen joint count (SJC),
Patient's Global Assessment of Disease Activity measured on a 10 cm visual analog scale (VAS), where 0 cm = lowest disease activity and 10 cm = highest;
Physician's Global Assessment of Disease Activity -measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest.
The CDAI score ranges from 0-76 where lower scores indicate less disease activity.
The following thresholds of disease activity have been defined for the CDAI:
Remission: ≤ 2.8 Low Disease Activity: > 2.8 and ≤ 10 Moderate Disease Activity: > 10 and ≤ 22 High Disease Activity: > 22."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.||units on a scale||Standard Deviation|Mean
823544|NCT01172938|Secondary|Change From Baseline in the Dactylitis Severity Score at Week 52|Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet will be rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a baseline value > 0 (i.e., pre-existing dactylitis) and a Week 52 value are included.||units on a scale||Standard Deviation|Mean
823601|NCT01173055|Secondary|Change in Pain Tolerance From Baseline to Week 9 of Treatment||Week 9||||||
823545|NCT01172938|Secondary|Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 52|"The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):
1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right.
The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses."|Baseline and week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a baseline value > 0 (i.e., pre-existing enthesopathy) and a Week 52 value are included.||units on a scale||Standard Deviation|Mean
823546|NCT01172938|Secondary|Change From Baseline in the Patient Assessment of Pain at Week 52|"The participant was asked to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents no pain, and the right-hand boundary (score = 100 mm) represents pain as severe as can be imagined. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.||mm||Standard Deviation|Mean
823547|NCT01172938|Secondary|Percentage of Participants With a Modified PsARC Response at Week 52|"Modified PsARC response is defined as improvement in at least 2 of the 4 measures, at least one of which must be tender joint count or swollen joint count, and no worsening in any of the 4 measures:
78 tender joint count,
76 swollen joint count,
Patient global assessment of disease activity, measured on a 100 mm visual Analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest;
Physician global assessment of disease activity, measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest.
Improvement or worsening in joint counts is defined as decrease or increase, respectively, from Baseline by ≥ 30%, and improvement or worsening in global assessments is defined as decrease or increase, respectively, from Baseline by ≥ 20 mm VAS.
Two-sided 95% confidence interval is based on the Clopper-Pearson method."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.||percentage of participants||95% Confidence Interval|Number
823548|NCT01172938|Secondary|Change From Baseline in the SF-36 Physical Functioning Domain at Week 52|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.||units on a scale||Standard Deviation|Mean
823549|NCT01172938|Secondary|Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 52|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.||units on a scale||Standard Deviation|Mean
823550|NCT01172938|Secondary|Percentage of Participants With a ACR 20 Response at Week 52|"Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:
≥ 20% improvement in 78 tender joint count;
≥ 20% improvement in 76 swollen joint count; and
≥ 20% improvement in at least 3 of the 5 following parameters:
Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
Patient's global assessment of disease activity (measured on a 100 mm VAS);
Physician's global assessment of disease activity (measured on a 100 mm VAS);
Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));
C-Reactive Protein."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population consists of all participants who were randomized or re-randomized to apremilast at any time during the study. Only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.||percentage of participants||95% Confidence Interval|Number
823551|NCT01172938|Secondary|Percentage of Participants Achieving a Dactylitis Score of Zero at Week 24|"Percentage of participants with pre-existing dactylitis whose dactylitis severity score improves to zero after 24 weeks of treatment.
Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present."|Week 24|Full analysis set; participants with a baseline dactylitis severity score > 0 are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
823602|NCT01173055|Secondary|Change in Pain Tolerance From Baseline to Week 6 of Treatment||Week 6||||||
823603|NCT01173055|Secondary|Pain Tolerance at Baseline|The primary outcome parameter is the pressure pain tolerance (maximum tolerated pressure) at pre-treatment baseline.|Week 0|||kg/cm^2||Standard Deviation|Mean
823604|NCT01173055|Secondary|Change in Diffuse Noxious Inhibitory Control (DNIC) Effect From Baseline to End of Treatment.|0-100 numerical rating scale. 0 on the numerical scale represents a better outcome. 100 represents a worse outcome.|Week 0 - Week 15|On participant did not complete this outcome measure.||units on a scale||Standard Deviation|Mean
823552|NCT01172938|Secondary|Percentage of Participants Achieving a MASES Score of Zero at Week 24|"Percentage of participants with pre-existing enthesopathy whose MASES improves to 0 after 24 weeks of treatment. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):
1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right.
The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses."|Week 24|Full analysis set; participants with a baseline MASES > 0 are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
823553|NCT01172938|Secondary|Percentage of Participants Achieving a Dactylitis Score of Zero at Week 16|"Percentage of participants with pre-existing dactylitis whose dactylitis severity score improves to zero after 16 weeks of treatment.
Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present."|Week 16|Full analysis set; participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
823554|NCT01172938|Secondary|Percentage of Participants Achieving a MASES Score of Zero at Week 16|"Percentage of participants with pre-existing enthesopathy whose MASES improves to 0 after 16 weeks of treatment. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):
1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right.
The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses."|Week 16|Full analysis set; participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
823555|NCT01172938|Secondary|Percentage of Participants With a ACR 70 Response at Week 24|"Percentage of participants with an American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:
≥ 70% improvement in 78 tender joint count;
≥ 70% improvement in 76 swollen joint count; and
≥ 70% improvement in at least 3 of the 5 following parameters:
Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
Patient's global assessment of disease activity (measured on a 100 mm VAS);
Physician's global assessment of disease activity (measured on a 100 mm VAS);
Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));
C-Reactive Protein."|Baseline and week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
823556|NCT01172938|Secondary|Percentage of Participants With an ACR 50 Response at Week 24|"Percentage of participants with an American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:
≥ 50% improvement in 78 tender joint count;
≥ 50% improvement in 76 swollen joint count; and
≥ 50% improvement in at least 3 of the 5 following parameters:
Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
Patient's global assessment of disease activity (measured on a 100 mm VAS);
Physician's global assessment of disease activity (measured on a 100 mm VAS);
Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));
C-Reactive Protein."|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
823557|NCT01172938|Secondary|Percentage of Participants With an ACR 70 Response at Week 16|"Percentage of participants with an American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:
≥ 70% improvement in 78 tender joint count;
≥ 70% improvement in 76 swollen joint count; and
≥ 70% improvement in at least 3 of the 5 following parameters:
Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
Patient's global assessment of disease activity (measured on a 100 mm VAS);
Physician's global assessment of disease activity (measured on a 100 mm VAS);
Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));
C-Reactive Protein."|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
823558|NCT01172938|Secondary|Percentage of Participants With a ACR 50 Response at Week 16|"Percentage of participants with an American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:
≥ 50% improvement in 78 tender joint count;
≥ 50% improvement in 76 swollen joint count; and
≥ 50% improvement in at least 3 of the 5 following parameters:
Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
Patient's global assessment of disease activity (measured on a 100 mm VAS);
Physician's global assessment of disease activity (measured on a 100 mm VAS);
Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));
C-Reactive Protein."|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
823605|NCT01173055|Secondary|Change in Diffuse Noxious Inhibitory Control (DNIC) Effect From Baseline to Week 9 of Treatment.||Week 9||||||
823606|NCT01173055|Secondary|Change in Diffuse Noxious Inhibitory Control (DNIC) Effect From Baseline to Week 6 of Treatment.||Week 6||||||
823559|NCT01172938|Secondary|Percentage of Participants With Good or Moderate EULAR Response at Week 24|"EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score.
A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 3.2.
A Moderate Response is defined as either:
an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 score of less than or equal to 5.1 or,
an improvement (decrease) in the DAS28 of more than 1.2 and attainment of a DAS28 score of greater than 3.2."|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
823560|NCT01172938|Secondary|Percentage of Participants With Dactylitis Improvement ≥ 1 Point at Week 24|"Percentage of participants with pre-existing dactylitis whose dactylitis severity score improved by ≥ 1 after 24 weeks of treatment.
Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present."|Baseline and Week 24|Full analysis set; participants with a baseline dactylitis severity score > 0 are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
823561|NCT01172938|Secondary|Percentage of Participants With MASES Improvement ≥ 20% at Week 24|"Percentage of participants with pre-existing enthesopathy whose MASES improved by ≥ 20% from Baseline after 24 weeks of treatment. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):
1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right.
The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses."|Baseline and Week 24|Full analysis set; participants with a baseline MASES > 0 are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
823562|NCT01172938|Secondary|Percentage of Participants With Good or Moderate European League Against Rheumatism (EULAR) Response at Week 16|"A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score.
A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 3.2.
A Moderate Response is defined as either:
an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 score of less than or equal to 5.1 or,
an improvement (decrease) in the DAS28 of more than 1.2 and attainment of a DAS28 score of greater than 3.2."|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
823563|NCT01172938|Secondary|Percentage of Participants With Dactylitis Improvement ≥ 1 Point at Week 16|"Percentage of participants with pre-existing dactylitis whose dactylitis severity score improved by ≥ 1 after 16 weeks of treatment.
Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present."|Baseline and Week 16|Full analysis set; participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
823564|NCT01172938|Secondary|Percentage of Participants With MASES Improvement ≥ 20% at Week 16|"Percentage of participants with pre-existing enthesopathy whose MASES improved by ≥ 20% from Baseline after 16 weeks of treatment. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):
1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right.
The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses."|Baseline and Week 16|Full analysis set; participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
823565|NCT01172938|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 24|"The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue. A positive change from Baseline score indicates an improvement."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||units on a scale||Standard Error|Least Squares Mean
823607|NCT01173055|Secondary|Diffuse Noxious Inhibitory Control (DNIC) Effect at Baseline.|0-100 numerical rating scale. 0 on the numerical scale represents a better outcome. 100 represents a worse outcome.|Week 0|One participant did not complete this outcome measure.||units on a scale||Standard Deviation|Mean
823690|NCT01175382|Primary|Change in Frequency of Urination After 6-week Intervention (Last Observation Carried Forward)|Bladder diaries completed by subjects prior to randomization and following the first phase of treatment was used to calculate changes in frequency of urination.|From Baseline to 6 Weeks|||voids per day||Standard Deviation|Mean
823566|NCT01172938|Secondary|Change From Baseline in the Disease Activity Score (DAS28) at Week 24|"The DAS28 measures the severity of disease at a specific time and is derived from the following variables:
28 tender joint count
28 swollen joint count, which do not include the DIP joints, the hip joint, or the joints below the knee;
C-reactive protein (CRP)
Patient's global assessment of disease activity.
DAS28(CRP) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||units on a scale||Standard Error|Least Squares Mean
823567|NCT01172938|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 24|"The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:
28 tender joint count (TJC),
28 swollen joint count (SJC),
Patient's Global Assessment of Disease Activity measured on a 10 cm visual analog scale (VAS), where 0 cm = lowest disease activity and 10 cm = highest;
Physician's Global Assessment of Disease Activity -measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest.
The CDAI score ranges from 0-76 where lower scores indicate less disease activity.
The following thresholds of disease activity have been defined for the CDAI:
Remission: ≤ 2.8; Low Disease Activity: > 2.8 and ≤ 10; Moderate Disease Activity: > 10 and ≤ 22; High Disease Activity: > 22."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||units on a scale||Standard Error|Least Squares Mean
823568|NCT01172938|Secondary|Change From Baseline in Dactylitis Severity Score at Week 24|Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet will be rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Baseline and Week 24|Full analysis set. Participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) and at least 1 postbaseline value at or prior to Week 24 are included. LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||units on a scale||Standard Error|Least Squares Mean
823569|NCT01172938|Secondary|Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 24|"The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):
1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right.
The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses."|Baseline and Week 24|Full analysis set; participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||units on a scale||Standard Error|Least Squares Mean
823570|NCT01172938|Secondary|Change From Baseline in Patient’s Assessment of Pain at Week 24|"The participant was asked to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents no pain, and the right-hand boundary (score = 100 mm) represents pain as severe as can be imagined. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||mm||Standard Error|Least Squares Mean
823571|NCT01172938|Secondary|Percentage of Participants With a Modified Psoriatic Arthritis Response Criteria (PsARC) Response at Week 24|"Modified PsARC response is defined as improvement in at least 2 of the 4 measures, at least one of which must be tender joint count or swollen joint count, and no worsening in any of the 4 measures:
78 tender joint count,
76 swollen joint count,
Patient global assessment of disease activity, measured on a 100 mm visual Analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest;
Physician global assessment of disease activity, measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest.
Improvement or worsening in joint counts is defined as decrease or increase, respectively, from baseline by ≥ 30%, and improvement or worsening in global assessments is defined as decrease or increase, respectively, from baseline by ≥ 20 mm VAS."|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
823572|NCT01172938|Secondary|Change From Baseline in SF-36 Physical Function at Week 24|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||units on a scale||Standard Error|Least Squares Mean
823573|NCT01172938|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 16|"The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue. A positive change from Baseline score indicates an improvement."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included. LOCF was used.||units on a scale||Standard Error|Least Squares Mean
823574|NCT01172938|Secondary|Change From Baseline in the Disease Activity Score (DAS28) at Week 16|"The DAS28 measures the severity of disease at a specific time and is derived from the following variables:
28 tender joint count
28 swollen joint count, which do not include the distal interphalangeal (DIP) joints, the hip joint, or the joints below the knee;
C-reactive protein (CRP)
Patient's global assessment of disease activity.
DAS28(CRP) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included. LOCF was used.||units on a scale||Standard Error|Least Squares Mean
823575|NCT01172938|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 16|"The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:
28 tender joint count (TJC),
28 swollen joint count (SJC),
Patient's Global Assessment of Disease Activity measured on a 10 cm visual analog scale (VAS), where 0 cm = lowest disease activity and 10 cm = highest;
Physician's Global Assessment of Disease Activity -measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest.
The CDAI score ranges from 0 to 76 where lower scores indicate less disease activity.
The following thresholds of disease activity have been defined for the CDAI:
Remission: ≤ 2.8 Low Disease Activity: > 2.8 and ≤ 10 Moderate Disease Activity: > 10 and ≤ 22 High Disease Activity: > 22."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included. LOCF was used.||units on a scale||Standard Error|Least Squares Mean
823576|NCT01172938|Secondary|Change From Baseline in Dactylitis Severity Score at Week 16|Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet will be rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Baseline and Week 16|Full analysis set. Participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) and at least 1 postbaseline value at or prior to Week 16 are included. LOCF was used.||units on a scale||Standard Error|Least Squares Mean
823577|NCT01172938|Secondary|Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 16|"The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):
1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right.
The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses."|Baseline and Week 16|Full analysis set; participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) and at least 1 postbaseline value at or prior to Week 16 are included; LOCF was used.||units on a scale||Standard Error|Least Squares Mean
823578|NCT01172938|Secondary|Change From Baseline in Patient’s Assessment of Pain at Week 16|"The participant was asked to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents no pain, and the right-hand boundary (score = 100 mm) represents pain as severe as can be imagined. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included; LOCF was used.||mm||Standard Error|Least Squares Mean
823579|NCT01172938|Secondary|Percentage of Participants With a Modified Psoriatic Arthritis Response Criteria (PsARC) Response at Week 16|"Modified PsARC response is defined as improvement in at least 2 of the 4 measures, at least one of which must be tender joint count or swollen joint count, and no worsening in any of the 4 measures:
78 tender joint count,
76 swollen joint count,
Patient global assessment of disease activity, measured on a 100 mm visual Analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest;
Physician global assessment of disease activity, measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest.
Improvement or worsening in joint counts is defined as decrease or increase, respectively, from Baseline by ≥ 30%, and improvement or worsening in global assessments is defined as decrease or increase, respectively, from Baseline by ≥ 20 mm VAS."|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
823580|NCT01172938|Secondary|Change From Baseline in 36-item Short Form Health Survey (SF-36) Physical Functioning Domain at Week 16|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included; LOCF was used.||units on a scale||Standard Error|Least Squares Mean
823581|NCT01172938|Secondary|Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 24|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||units on a scale||Standard Error|Least Squares Mean
823582|NCT01172938|Secondary|Percentage of Participants With an ACR 20 Response at Week 24|"Percentage of participants with an American College of Rheumatology 20% (ACR20) response at Week 24. A participant was a responder if the following 3 criteria for improvement from Baseline were met:
≥ 20% improvement in 78 tender joint count;
≥ 20% improvement in 76 swollen joint count; and
≥ 20% improvement in at least 3 of the 5 following parameters:
Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
Patient's global assessment of disease activity (measured on a 100 mm VAS);
Physician's global assessment of disease activity (measured on a 100 mm VAS);
Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));
C-Reactive Protein."|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
823583|NCT01172938|Secondary|Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 16|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included; Last observation carried forward (LOCF) imputation was used.||units on a scale||Standard Error|Least Squares Mean
823584|NCT01172938|Primary|Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 16|"Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:
≥ 20% improvement in 78 tender joint count;
≥ 20% improvement in 76 swollen joint count; and
≥ 20% improvement in at least 3 of the 5 following parameters:
Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
Patient's global assessment of disease activity (measured on a 100 mm VAS);
Physician's global assessment of disease activity (measured on a 100 mm VAS);
Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));
C-Reactive Protein."|Baseline and Week 16|Full analysis set consisting of all participants randomized as specified in the protocol. Participants who withdrew early or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
823585|NCT01173029|Post-Hoc|Polygenic Risk Score|"Among all analyzed, four renin-angiotensin-aldosterone polymorphisms had statistical significance relating to composite endpoint.
They were: Angiotensinogen, renin, angiotensin II type 1 receptor and aldosterone synthase. Each polymorphism was arbitrarily weighted according to respective presentation in both alleles as follows: zero (low risk homozygosis), one (heterozygosis) and two (high risk homozygosis). In a following step, they were summed up for each subject, thus, creating a polygenic risk score.
The weights of the polymorphisms were, thus, defined:
Angiotensinogen: MM - zero, MT - one, TT - two
Renin: AA - zero, GA - one, GG - two
Angiotensin II type 1 receptor: CC - zero, AC - one, AA - two
Aldosterone synthase: CC - zero, TC - one, TT - two
The polygenic risk score value ranges from zero (all low risk polymorphisms in homozygosis) to eight (all high risk polymorphisms in homozygosis)."|up to 10 years|Subjects in both resistant systemic arterial hypertension and pseudo-resistant systemic arterial hypertension groups had their respective genetic background scored according to present rule.||composite enpoint events|||Number
823586|NCT01173029|Secondary|Composite of Acute Myocardial Infarctions and/or Strokes Either Fatal or Nonfatal|"Evidence of clinically definite stroke (focal neurological deficits persisting for more than 24 hours) confirmed or not by non-investigational computerized tomography.
Evidence of clinically definite acute myocardial infarction (prolonged > 20min chest pain, not relieved by sublingual nitrate, ST-T segment deviation on 12-lead surface ECG, elevation of plasma troponin >0.2 ng/dL 6h following chest pain episode).
Death was considered to be related to the event if occurring up to 30 days after the acute event.
Assessment twice an year by active and direct contact to patients or relatives and review of medical records."|up to 10 years|"Number of participants was based on input demand at outpatient clinics. Those who provided provided consent for genetic testing were included.
A post-hoc sampling procedure (power calculation) validated sample size."||participants|||Number
823587|NCT01173029|Primary|Strokes, Either Fatal or Nonfatal|"Evidence of clinically definite stroke (focal neurological deficits persisting for more than 24 hours) confirmed or not by non-investigational computerized tomography.
Death was considered to be related to the event if occurring up to 30 days after the acute event.
Assessment twice an year by active and direct contact to patients or relatives and review of medical records."|up to 10 years|"Number of participants was based on input demand at outpatient clinics. Those who provided provided consent for genetic testing were included.
A post-hoc sampling procedure (power calculation) validated sample size."||participants|||Number
823588|NCT01173055|Secondary|Change in fMRI Activation Patterns During N-back Procedure From Baseline to Week 15 of Treatment.||Week 15||||||
823589|NCT01173055|Secondary|Change in fMRI Activation Patterns During N-back Procedure From Baseline to Week 9 of Treatment.||Week 9||||||
823590|NCT01173055|Secondary|Change in fMRI Activation Patterns During N-back Procedure From Baseline to Week 6 of Treatment.||Week 6||||||
823591|NCT01173055|Secondary|Change in fMRI Activation Patterns During N-back Procedure From Baseline to End of Treatment.||Week 0||||||
823592|NCT01173055|Secondary|Change in Descending Pain Modulation From Baseline to Week 15 of Treatment (as Assessed by Changes in fMRI Brainstem Activation Patterns)||Week 15||||||
823593|NCT01173055|Secondary|Change in Descending Pain Modulation From Baseline to Week 9 of Treatment (as Assessed by Changes in fMRI Brainstem Activation Patterns)||Week 9||||||
823594|NCT01173055|Secondary|Change in Descending Pain Modulation From Baseline to Week 6 of Treatment (as Assessed by Changes in fMRI Brainstem Activation Patterns)||Week 6||||||
823595|NCT01173055|Secondary|Change in Descending Pain Modulation From Baseline to End of Treatment (as Assessed by Changes in fMRI Brainstem Activation Patterns)||Week 0 - Week 15||||||
823596|NCT01173055|Secondary|Change in fMRI Brain Activation Patterns During Pressure Stimulation From Baseline to Week 15 of Treatment||Week 15||||||
823608|NCT01173055|Primary|Change in Pain Threshold From Baseline to End of Treatment.|The primary outcome parameter is the change in medium pressure pain threshold (pressure that evokes a perceived pain intensity of 40-50 out of 100 on a numerical rating scale) from baseline to end of treatment. Measured in kg/cm^2. Lower values represent a worse outcome.|Week 0 - Week 15|||kg/cm^2||Standard Deviation|Mean
823609|NCT01173055|Primary|Change in Pain Threshold From Baseline to Week 9 of Treatment|The primary outcome parameter is the change in medium pressure pain threshold from baseline to end of treatment.|Week 9||||||
823610|NCT01173055|Primary|Change in Pain Threshold From Baseline to Week 6 of Treatment.|The primary outcome parameter is the change in medium pressure pain threshold from baseline to week 6 of treatment.|Week 6||||||
823611|NCT01173055|Primary|Pain Threshold at Baseline|The primary outcome parameter is the medium pressure pain threshold at pre-treatment baseline (pressure that evokes a perceived pain intensity of 40-50 out of 100 on a numerical rating scale). Measured in kg/cm^2.|Week 0|||kg/cm^2||Standard Deviation|Mean
823612|NCT01173120|Secondary|Number of Participants With Positive Anti-abatacept Responses Over Time by Electrochemiluminescence Immunoassay in the ACP Device Substudy|An electrochemiluminescence immunoassay screened sera for drug-specific antibodies; immunocompetition was used to identify specific anti-Abatacept reactivity. CTLA4 and Possibly immunoglobulin (Ig) category=reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction (JNCT)category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing. TRT=treatment|ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 85 days post last ACP dose|Immunogenicity Population, defined as all participants who received at least 1 dose of abatacept administered with the ACP who had at least one post Substudy Day 1 immunogenicity result available.||participants|||Number
823613|NCT01173120|Secondary|Number of Participants With Positive Anti-abatacept or Anti-Cytotoxic T Lymphocyte Antigen 4-T Cell (CTLA4-T) Responses Over Time by Enzyme Linked Immunosorbant Assay (ELISA) in the ACP Device Substudy|Serum samples from all treated adult participants with active rheumatoid arthritis were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.|ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 28 days post last ACP dose|Immunogenicity Population, defined as all participants who received at least 1 dose of abatacept administered with the ACP who had at least one post Substudy Day 1 immunogenicity result available.||participants|||Number
823614|NCT01173120|Primary|Mean Temperature Over Time in the ACP Device Substudy||ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 7 days post last ACP dose.|As-Treated Population, defined as all participants enrolled in ACP substudy who received at least 1 dose of SC abatacept administered via the ACP.||degrees Celsius||Standard Deviation|Mean
823615|NCT01173120|Primary|Mean Heart Rate Over Time in the ACP Device Substudy||ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 7 days post last ACP dose.|As-Treated Population, defined as all participants enrolled in ACP substudy who received at least 1 dose of SC abatacept administered via the ACP.||beats per minute||Standard Deviation|Mean
823616|NCT01173120|Primary|Mean Diastolic Blood Pressure (DBP) Over Time in the ACP Device Substudy||ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 7 days post last ACP dose.|As-Treated Population, defined as all participants enrolled in ACP substudy who received at least 1 dose of SC abatacept administered via the ACP.||mm Hg||Standard Deviation|Mean
823617|NCT01173120|Primary|Mean Systolic Blood Pressure (SBP) Over Time in the ACP Device Substudy||ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 7 days post last ACP dose.|As-Treated Population, defined as all participants enrolled in ACP substudy who received at least 1 dose of SC abatacept administered via the ACP.||mm Hg||Standard Deviation|Mean
823618|NCT01173120|Primary|Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria in the ACP Device Substudy|MA criteria: serum glucose (Glu): <65 mg/dL/>220 mg/dL;fasting serum Glu: <0.8* LLN/>1.5*ULN,or if BL<LLN then use 0.8*BL or >ULN,or if BL>ULN then use >2.0*BL or <LLN;total protein: <0.9*LLN/>1.1*ULN,or if BL<LLN then use <0.9*BL or >UNL,or if BL>UNL then use >1.1*BL or <LLN; albumin: <0.9*LLN,or if BL<LLN then use <0.75 BL;uric acid: >1.5*ULN,or if BL>ULN then use >2*BL. Urinalysis (Urine protein,urine Glu,urine blood,leukocyte esterase,Red Blood Cells [RBCs], White Blood Cells [WBCs]):Use ≥2 when BL value missing or when pre-dose=0 or 0.5; use ≥3 when pre-dose=1, use ≥4 when pre-dose=2 or 3|ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 7 days post last ACP dose.|As-Treated Population, defined as all participants enrolled in ACP substudy who received at least 1 dose of SC abatacept administered via the ACP.||participants|||Number
823691|NCT01175395|Secondary|To Determine the Number of Retreatments With Lucentis in Eyes Initially Treated With 20089 TA and Lucentis|Because of the combination - 20089/Lucentis - treatment, patients may not require monthly Lucentis injections as is the current standard of care practice for AMD.|30 to 360 days|||retreatments||Full Range|Median
823619|NCT01173120|Primary|Number of Participants With Electrolyte Laboratories Meeting MA Criteria in the ACP Device Substudy|Marked abnormality criteria: Sodium (Na): <0.95*LLN/ >1.05*ULN, or if BL<LLN then use <0.95* BL or >ULN, or if BL>ULN then use>1.05* BL or <LLN; potassium (K): <0.9* LLN/>1.1*ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; (Cl): <0.9* LLN/>1.1* ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; calcium (Ca): <0.8* LLN/>1.2* ULN, or if BL<LLN then use <0.75* BL or >ULN, or if BL>ULN then use>1.25* BL or <LLN; phosphorous (P): <0.75* LLN/ >1.25* ULN, or if BL<LLN then use 0.67* BL or >ULN, or if BL>ULN then use>1.33* BL or <LLN|ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 7 days post last ACP dose.|As-Treated Population, defined as all participants enrolled in ACP substudy who received at least 1 dose of SC abatacept administered via the ACP.||participants|||Number
823620|NCT01173120|Primary|Number of Participants With Liver Function Laboratories Meeting MA Criteria in the ACP Device Substudy|Marked abnormality criteria: Alkaline phosphatase (ALP): >2* ULN, or if BL>ULN then use >3* BL; aspartate aminotransferase (AST): >3* ULN, or if BL>ULN then use >4* BL; alanine aminotransferase (ALT): >3* ULN, or if BL>ULN then use >4* BL; G-Glutamyl transferase (GGT): >2* ULN, or if BL>ULN then use >3* BL; Bilirubin: >2* ULN, or if BL>ULN then use >4* BL; blood urea nitrogen (BUN): >2* BL; creatinine: >1.5* BL|ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 7 days post last ACP dose.|As-Treated Population, defined as all participants enrolled in ACP substudy who received at least 1 dose of SC abatacept administered via the ACP.||participants|||Number
823621|NCT01173120|Primary|Number of Participants With Laboratory Test Results in Hematology Meeting the Criteria for Marked Abnormality in the ACP Device Substudy|BL=baseline; LLN lower limit of normal; ULN=upper limit of normal. Marked abnormality criteria: Hemoglobin: >3 g/dL decrease from BL; Hematocrit: <0.75*BL; Erythrocytes: <0.75*BL; Platelets: <0.67*LLN/>1.5*ULN, or if BL <LLN, use 0.5*BL/<100,000 mm^3; Leukocytes: <0.75*LLN/ >1.25*ULN, or if BL<LLN, use <0.8*BL/>ULN, or if BL>ULN, use >1.2*BL/<LLN; neutrophils+bands: <1.0*10^3 c/uL; eosinophils: >0.750*10^3 c/uL; basophils: >400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750*10^3 c/uL/ >7.50*10^3 c/uL.|ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 7 days post last ACP dose.|As-Treated Population, defined as all participants enrolled in ACP substudy who received at least 1 dose of SC abatacept administered via the ACP.||participants|||Number
823622|NCT01173120|Primary|Number of Participants With AEs of Special Interest in the ACP Device Substudy|AE=any new untoward medical occurrence or worsening of a preexisting medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs including all infections, local injection reactions (prespecified), and systemic injection reactions (within 24 hours of dosing).|ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 56 days post last ACP dose|As-Treated Population, defined as all participants enrolled in ACP substudy who received at least 1 dose of subcutaneous abatacept administered via the ACP.||participants|||Number
823623|NCT01173120|Secondary|Minimum Observed Serum Concentration (Cmin) of Abatacept Over Time in the ACP Device Substudy|Trough levels of abatacept were evaluated based upon serum samples. Day 1 pharmacokinetics were based on exposure to the pre-filled syringes and did not reflect abatacept exposure via the ACP device.|Days 1, 29, 57, 85, 169, and 253 of ACP substudy|As-Treated Population, defined as all participants enrolled in ACP substudy who received at least 1 dose of SC abatacept administered via the ACP. Trough concentrations in participants who discontinued from the substudy were not summarized descriptively, but were included in the concentration listings.||ug/mL||Standard Deviation|Geometric Mean
823624|NCT01173120|Primary|Number of Participants With Death, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Treatment-related AEs, and AEs Leading to Discontinuation|An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=possibly, probably, or certainly related to and of unknown relationship to study treatment.|ACP substudy Day 1 to last substudy assessment occurring prior to the 1st dose of non-ACP subcutaneous (SC) abatacept, assessed up to 12 months|As-Treated Population, defined as all participants enrolled in ACP substudy who received at least 1 dose of SC abatacept administered via the ACP.||participants|||Number
823625|NCT01175148|Primary|Cummalative Incidence of Grade 2 to 4 Acute Graft vs Host Diesease (GVHD) at Day 100 Post Transplant in HSCT Recipients|Cummalative incidence of grade 2 to 4 acute Graft vs Host Diesease (GVHD) at day 100 post transplant will be will be histologically confirmed and graded in Hematopoietic Stem Cell Transplantation Recipients|100 days post transplant|Only the Recipients were analyzed for the outcome measurements.||percentage of participants||95% Confidence Interval|Number
823650|NCT01175226|Primary|Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Questionnaire|Daily Change in WURSS-21 Severity Score Averaged over Days 2 to 4. The Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Questionnaire is an evaluative illness-specific outcomes instrument designed to assess the severity of cold symptoms and the impact of the common cold (range 0-140), with higher scores indicating more symptoms and functional impairment.|Days 2-4|Intent-to-Treat Infected (ITT-I) Population - all randomized subjects who had a PCR positive result for rhinovirus from nasal swab on Days 1, 3, 5 and 7 with at least 1 post-baseline measurement of efficacy.||Scores on a scale||Standard Error|Least Squares Mean
823651|NCT01175317|Secondary|Average Intraoperative CO2 Gap|"The CO2 gap (difference arterial pCO2 and pCO2 of the stomach lumen) reflects global intestinal perfusion status and is measured every 15 minutes intraoperatively and every 60 minutes during the first 8 hours postoperatively.
Intraoperative measurements were averaged per individual patient, producing the average intraoperative CO2 gap."|Average intraoperative CO2 gap|||kPa||Standard Deviation|Mean
823652|NCT01175317|Primary|Peak Value of I-FABP|"Intestinal-Fatty Acid Binding Protein (a marker of intestinal damage) is measured in plasma.
The primary outcome measure is the difference in peak values of I-FABP between the control group and the intervention group."|1 hour postoperatively|||pg/mL||Standard Deviation|Mean
823653|NCT01175343|Secondary|Impact of RO49097 on Ascitic Fluid Circulating Tumor Cells|Impact of RO49097 on ascitic fluid circulating tumor cells.|Up to 2 years|Data were not collected.|||||
823654|NCT01175343|Secondary|Expression of Notch Biomarkers in Advanced Platinum Resistant Ovarian, Fallopian, and Primary Peritoneal Cancers.|An exploratory analysis for potential predictive biomarkers was performed on archival, paraffin-embedded tumor tissue for components of the Notch Pathway: Jagged-1 and NICD. The percentage of positive cells were scored into four categories: 0 (0%), 1 (1-33%), 2 (34-66%), and 3 (67-100%). The product of the intensity and percentage scores was used as the final score and classified as negative (0-4) or positive (5-9).|Up to 2 years|25 patients were assessed for Jagged-1 expression. 17 patients that were evaluable for response were assessed for NICD expression.||Participants|||Count of Participants
823655|NCT01175343|Secondary|Frequency and Severity of Adverse Events|Tabulated using counts and proportions detailing frequently occurring, serious and severe events of interest.|Up to 2 years|Adverse events analyzed include all serious adverse events (SAEs), and other (non-serious) treatment-related adverse events.There are 21 SAEs and 72 other (non-serious) adverse events.||Adverse Events|Adverse Events||Count of Units
823656|NCT01175343|Secondary|Overall Survival|Summary statistics, such as mean, median, counts and proportion, used to summarize the patients. Survival estimates computed using Kaplan-Meier method. Potential association between variables measured using Pearson correlation coefficients, chi-square tests, one- or two-sample t-tests or logistic regression analyses as appropriate. Non-parametric tests such as Spearman correlation coefficients, Fisher’s exact tests and Wilcoxon rank sum tests may be substituted if necessary. Ninety-five percent confidence intervals will be constructed and selected results illustrated using figures and plots.|Up to 2 years|40 patients are evaluable for response.||months||95% Confidence Interval|Median
823657|NCT01175343|Secondary|CA125 Response Rate (GCIG Criteria)|"The CA-125 response rate is defined as the proportion of patients with a Gynecological Cancer Intergroup (GCIG) CA-125 response.
CA-125 response is defined as the moment CA-125 is reduced by 50% from the last pre-treatment level prior to start of therapy. The response must be confirmed and maintained with a consecutive CA-125 for at least 28 days."|Time from start of treatment to time of disease progression or death from any cause, whichever came first, assessed up to 2 years|There are 40 patients evaluable for response.||Participants|||Count of Participants
823658|NCT01175343|Secondary|Overall Response Rate|"Response was assessed by Response Evaluation Criteria In Solid Tumors (RECIST 1.1).
Evaluation of Target Lesions:
Complete response (CR) - disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
Partial response (PR) - at least 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Evaluation of Non-Target Lesions:
Complete response (CR) - disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 mm short axis)."|Time from start of treatment to time of disease progression or death from any cause, whichever came first, assessed up to 2 years|||Participants|||Count of Participants
823659|NCT01175343|Primary|Four Cycle Progression-free Survival Rate|"Defined as the proportion of the study population that has not had tumor progression (symptomatic, RECIST progression, CA-125 progression) or died at the completion of the cycle four mark.
RECIST criteria for progressive disease (PD) in target lesions: >= 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. The appearance of one or more new lesions is also considered progression. In non-target lesions: Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
CA-125 PD is based on the progressive serial elevation of serum CA-125 according to:
A) elevated CA-125 pretreatment & normalization of CA-125 or C) CA-125 in normal range pretreatment: CA-125 >= 2x ULN on 2 occasions.
B) elevated CA-125 pretreatment that never normalizes: CA-125 >= 2x nadir value on 2 occasions"|84 days (4 courses)|||Participants|||Count of Participants
823660|NCT01175356|Secondary|Incidence of Unacceptable Toxicity and Sinusoidal Obstruction Syndrome (SOS), Assessed by Common Terminology Criteria (CTV)v.4.0 for Toxicity Assessment and Grading for I-MIBG|Number of patients who had an unacceptable toxicity or experienced SOS. Unacceptable toxicity was defined as CTC Grade 4-5 Pulmonary/Respiratory.|Up to 6 weeks after course 5 of induction|Includes patients who received 131I-MIBG therapy.||Participants|||Count of Participants
823661|NCT01175356|Primary|Percentage of MIBG Avid Patients Treated With MIBG Labeled With Iodine-131 and Bu/Mel Chemotherapy|Number of MIBG avid patients who receive 131I-MIBG and Bu/Mel divided by the number of patients evaluable for the feasibility of MIBG and Bu/Mel consolidation endpoint x 100%.|Up to day -6 of conditioning|Includes patients who met criteria to receive 131I-MIBG but went off protocol therapy before receiving a dose assignment, but excludes patients that could not receive 131I-MIBG therapy due to lack of an open treatment slot. The definition of receiving Bu/Mel conditioning is receiving the first dose of planned Busulfan on Day -6 of conditioning.||Percentage of participants||95% Confidence Interval|Number
825990|NCT01195090|Primary|Mean Change in Glycosylated Hemoglobin (A1C)|A1C change from baseline to 24 weeks|24 weeks|An intent-to-treat analysis with last observation carried forward was used to assess efficacy.||percentage of Hb||Standard Error|Least Squares Mean
823662|NCT01175356|Primary|Percentage of MIBG Avid Patients Treated With Meta-iodobenxylguanide (MIBG) Labeled With Iodine-131|Number of MIBG avid patients who receive 131I-MIBG divided by the number of patients evaluable for the feasibility of MIBG endpoint x 100%.|Up to 6 weeks after course 5 of induction|Includes patients who met criteria to receive 131I-MIBG but went off protocol therapy before receiving a dose assignment, but excludes patients that could not continue onto 131I-MIBG therapy due to lack of an open treatment slot. The definition of receiving MIBG labeled with iodine-131 is receiving 131I-MIBG.||Percentage of participants||95% Confidence Interval|Number
823663|NCT01175369|Secondary|Additional Asthma Morbidity Outcomes|We will look at additional asthma morbidity outcomes including symptom nights, days needing rescue medications, functional severity, days absent from school, and quality of life.|1-9 months (Monthly Follow-up assessments)||||||
823664|NCT01175369|Secondary|Cost Effectiveness of the Intervention|Cost-effectiveness will examine the net program costs to the number of symptom-free days gained. Benefits will be described as the net difference in medical and productivity costs between children in the treatment and control groups.|approximately 9 months (length of school year)||||||
823665|NCT01175369|Secondary|Cotinine Level|To test the effectiveness of the environmental tobacco smoke (ETS) reduction portion of the study, we will compare baseline cotinine values to 2 month (for smoke exposed participants) and final follow-up assessments (for all participants).|2 month and approximately 9 month (end of school year) follow-up assessments||||||
823666|NCT01175369|Primary|Number of Symptom Free Days|The primary outcome variable is the average number of symptom free days over 2 weeks assessed during peak asthma season (data collected during November, December, January and February during the school year).|Average Symptom Free Days, over 2 weeks, during peak asthma season (November-February)|||Days||Standard Deviation|Mean
823667|NCT01175382|Secondary|Change in International Prostate Symptom Score (I-PSS) From Baseline to 12 Weeks (Last Observation Carried Forward)|Change from Baseline to 12 weeks on the International Prostate Symptom Score (I-PSS) to measure urinary symptoms related to BPH. The I-PSS is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).|From Baseline to 12 weeks|||units on a scale||Standard Deviation|Mean
823668|NCT01175382|Secondary|Change in Overactive Bladder Questionnaire (OAB-q) From Baseline to 12 Weeks (Last Observation Carried Forward)|Change from baseline to 12 weeks on the OAB-q to measure symptom bother and condition-specific health-related quality of life. This questionnaire asks about how much you have been bothered by selected bladder symptoms during the past 4 weeks. Scale ranges from 8 to 48 with higher scores indicating a greater degree of bother.|From Baseline to 12 weeks|||units on a scale||Standard Deviation|Mean
823669|NCT01175382|Secondary|Change in Urinary Incontinence Episodes From Baseline to 12 Weeks (Last Observation Carried Forward)|Bladder diaries completed by subjects prior to randomization and following each phase of treatment will be used to calculate changes in frequency of urination|From Baseline to 12 weeks|||voids per day||Standard Deviation|Mean
823670|NCT01175382|Secondary|Change in Urgency Score From Baseline to 12 Weeks (Last Observation Carried Forward)|Bladder diaries completed by subjects prior to randomization and following each phase of treatment will be used to calculate changes in frequency of urgency associated with each void and incontinent episode using the Indevus Urgency Severity Scale (IUSS). IUSS asks patients about the degree of urgency, as meant to describe the urge to urinate. Patients are asked to rate the degree of urgency and its impact on the completion of activity or tasks during the time that the urgency sensation is present and before reaching the toilet for a toilet void. Four distinct, subjective degrees of urgency severity were identified, including 1) no sensation of urgency, 2) awareness of urgency but easily tolerated, 3) urgency that is somewhat uncomfortable and 4) extreme urgency discomfort.|From Baseline to 12 weeks|||units on a scale||Standard Deviation|Mean
823671|NCT01175382|Secondary|Change in Nocturia Measured From Baseline to 12 Weeks (Last Observation Carried Forward)|Bladder diaries completed by subjects prior to randomization and following each phase of treatment will be used to calculate changes in the frequency nocturia|From Baseline to 12 weeks|||voids per night||Standard Deviation|Mean
823672|NCT01175382|Secondary|How Bothersome Were Side Effects? 12 Week Report|Ordinal Rating regarding how bothersome side effects were|12 weeks post randomization|Sample sizes reported for analysis differs from the sample size in the Participant Flow Module for Outcomes in patient satisfaction, perception of improvement and bothersome side effects due to patients, either not completing the form or non-response to the questions, although they still enrolled in the study (applies for both 6 &12 week analysis).||Participants|||Count of Participants
823673|NCT01175382|Secondary|Satisfaction With Progress at 12 Weeks|Patient global ratings of satisfaction using the validated Patient Satisfaction Question.|12 weeks post randomization|Sample sizes reported for analysis differs from the sample size in the Participant Flow Module for Outcomes in patient satisfaction, perception of improvement and bothersome side effects due to patients, either not completing the form or non-response to the questions, although they still enrolled in the study (applies for both 6 &12 week analysis).||Participants|||Count of Participants
823674|NCT01175382|Secondary|Patient Perception of Improvement at 12 Weeks|Patient global ratings of improvement using the validated Estimated Percent Improvement and Global Perception of Improvement.|12 weeks post randomization|Sample sizes reported for analysis differs from the sample size in the Participant Flow Module for Outcomes in patient satisfaction, perception of improvement and bothersome side effects due to patients, either not completing the form or non-response to the questions, although they still enrolled in the study (applies for both 6 &12 week analysis).||Participants|||Count of Participants
823675|NCT01175382|Secondary|Change in International Prostate Symptom Score (IPSS) From 6 to 12 Weeks (Last Observation Carried Forward)|Change from 6 weeks to 12 weeks on the International Prostate Symptom Score (IPSS) to measure urinary symptoms related to BPH.The I-PSS is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).|Change from 6 weeks to 12 weeks|||units on a scale||Standard Deviation|Mean
823676|NCT01175382|Secondary|Change in Overactive Bladder Questionnaire (OAB-q) From 6 to 12 Weeks (Last Observation Carried Forward)|Change from 6 weeks to 12 weeks on the OAB-q to measure symptom bother and condition-specific health-related quality of life. This questionnaire asks about how much you have been bothered by selected bladder symptoms during the past 4 weeks. Scale ranges from 8 to 48 with higher scores indicating a greater degree of bother.|Change from 6 week to 12 weeks|||units on a scale||Standard Deviation|Mean
823677|NCT01175382|Secondary|Change in Nocturia From 6 Weeks to 12 Weeks (Last Observation Carried Forward)|Bladder diaries completed by subjects prior to randomization and following each phase of treatment will be used to calculate changes in frequency of nocturia|Change from 6 weeks to 12 weeks|||Voids per night||Standard Deviation|Mean
823678|NCT01175382|Secondary|Change in Urinary Incontinence From 6 Weeks to 12 Weeks (Last Observation Carried Forward)|Bladder diaries completed by subjects prior to randomization and following each phase of treatment will be used to calculate changes in frequency of incontinence episodes.|Change from 6 weeks to 12 weeks|||Episodes per week||Standard Deviation|Mean
823679|NCT01175382|Secondary|Change in Urgency Score From 6 Weeks to 12 Weeks (Last Observation Carried Forward)|Bladder diaries completed by subjects prior to randomization and following each phase of treatment will be used to calculate changes in urgency associated with each void and incontinent episode using the Indevus Urgency Severity Scale (IUSS). IUSS asks patients about the degree of urgency, as meant to describe the urge to urinate. Patients are asked to rate the degree of urgency and its impact on the completion of activity or tasks during the time that the urgency sensation is present and before reaching the toilet for a toilet void. Four distinct, subjective degrees of urgency severity were identified, including 1) no sensation of urgency, 2) awareness of urgency but easily tolerated, 3) urgency that is somewhat uncomfortable and 4) extreme urgency discomfort.|Change from 6 weeks to 12 weeks|||units on a scale||Standard Deviation|Mean
823680|NCT01175382|Secondary|How Bothersome Were Side Effects? 6 Week Report|Ordinal Rating regarding how bothersome side effects were|From Baseline to 6 weeks|Sample sizes reported for analysis differs from the sample size in the Participant Flow Module for Outcomes in patient satisfaction, perception of improvement and bothersome side effects due to patients, either not completing the form or non-response to the questions, although they still enrolled in the study (applies for both 6 &12 week analysis).||Participants|||Count of Participants
823681|NCT01175382|Secondary|Patient Perceptions of Improvement|Patient global ratings of improvement using the validated Estimated Percent Improvement and Global Perception of Improvement|From Baseline to 6 Weeks|Sample sizes reported for analysis differs from the sample size in the Participant Flow Module for Outcomes in patient satisfaction, perception of improvement and bothersome side effects due to patients, either not completing the form or non-response to the questions, although they still enrolled in the study (applies for both 6 &12 week analysis).||Participants|||Count of Participants
823682|NCT01175382|Secondary|Patient Satisfaction|Patient global ratings of satisfaction using the validated Patient Satisfaction Question|From Baseline to 6 Weeks|Sample sizes reported for analysis differs from the sample size in the Participant Flow Module for Outcomes in patient satisfaction, perception of improvement and bothersome side effects due to patients, either not completing the form or non-response to the questions, although they still enrolled in the study (applies for both 6 &12 week analysis).||Participants|||Count of Participants
823683|NCT01175382|Secondary|Change in International Prostate Symptom Score (I-PSS) From Baseline to 6 Weeks. (Last Observation Carried Forward)|Change from baseline to 6 weeks on the International Prostate Symptom Score (IPSS) to measure urinary symptoms related to benign prostatic hypertrophy (BPH). The I-PSS is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).|From Baseline to 6 Weeks|||units on a scale||Standard Deviation|Mean
823684|NCT01175382|Secondary|Change in Overactive Bladder Questionnaire (OAB-q) From Baseline to 6 Weeks (Last Observation Carried Forward)|Change from baseline on the OAB-q to measure symptom bother and condition-specific health-related quality of life. This questionnaire asks about how much you have been bothered by selected bladder symptoms during the past 4 weeks. Scale ranges from 8 to 48 with higher scores indicating a greater degree of bother.|From Baseline to 6 Weeks|||units on a scale||Standard Deviation|Mean
823685|NCT01175382|Secondary|Change in Nocturia From Baseline to 6 Weeks (Last Observation Carried Forward)|Bladder diaries completed prior to randomization and following each phase of treatment will be used to calculate changes in frequency of nocturia.|From Baseline to 6 Weeks|||voids per night||Standard Deviation|Mean
823686|NCT01175382|Secondary|Change in Urinary Incontinence From Baseline to 6 Weeks (Last Observation Carried Forward)|Bladder diaries completed prior to randomization and following each phase of treatment will be used to calculate changes in frequency of incontinence episodes.|From Baseline to 6 Weeks|||episodes per week||Standard Deviation|Mean
823687|NCT01175382|Secondary|Change in Urgency From Baseline to 6 Weeks (Last Observation Carried Forward)|Bladder diaries completed prior to randomization and following each phase of treatment will be used to calculate changes in urgency associated with each void and incontinent episode using the Indevus Urgency Severity Scale (IUSS). IUSS asks patients about the degree of urgency, as meant to describe the urge to urinate. Patients are asked to rate the degree of urgency and its impact on the completion of activity or tasks during the time that the urgency sensation is present and before reaching the toilet for a toilet void. Four distinct, subjective degrees of urgency severity were identified, including 1) no sensation of urgency, 2) awareness of urgency but easily tolerated, 3) urgency that is somewhat uncomfortable and 4) extreme urgency discomfort.|From Baseline to 6 Weeks|||units on a scale||Standard Deviation|Mean
823688|NCT01175382|Primary|Change in Frequency of Urination From Baseline to 12 Weeks (Last Observation Carried Forward)|Bladder diaries completed by subjects prior to randomization and following the second phase of treatment were used to calculate changes in frequency of urination|Baseline to 12 weeks|||Voids per day||Standard Deviation|Mean
823689|NCT01175382|Primary|Change in Frequency of Urination From 6 Weeks to 12 Weeks (Last Observation Carried Forward)|Bladder diaries completed by subjects prior to randomization and following each phase of treatment were used to calculate changes in frequency of urination.|Change from 6 weeks to 12 weeks|||Voids per day||Standard Deviation|Mean
823692|NCT01175395|Primary|To Assess the Safety & Tolerability of 20089 TA (6.9 mg or 13.8 mg) When Used Adjunctively With Lucentis 0.5 mg in Subjects With Sub-foveal Neovascular AMD|"The primary objective is to assess the ocular safety of 20089 TA (6.9 mg or 13.8 mg)treatment in combination with Lucentis.
The ocular safety endpoints to be assessed include the number of participants with ocular Adverse Events such as: evidence of endophthalmitis, uveitis, ocular hemorrhage, retinal tear or detachment to be assessed during ophthalmic examinations. Elevated IOP as measured by an applanation tonometer at every visit."|360 Days|||Number-participants with adverse events|||Number
823693|NCT01175434|Secondary|Feasibility and Acceptability|We will conduct interviews with parents and school nurses to evaluate whether this new program is feasible and acceptable among this population.|one year||||||
823694|NCT01175434|Secondary|Cost Effectiveness|We will evaluate the cost effectiveness to implement and sustain the web-based system in schools. We will review the cost of the intervention using three main categories of costs; programmatic costs (costs of initiating and running the program), productivity costs, and medical costs estimated at the individual child level.|one year||||||
823695|NCT01175434|Primary|Average Number of Symptom-free Days Over 14 Days; (Symptom-free Days Are Averaged Over 4 Bi-monthly Follow-ups)|The primary outcome is asthma morbidity between groups. We will measure asthma morbidity by looking at the average number of symptom-free days, over 2 weeks, at each bi-monthly follow-up time point over the school year. Number of days without asthma symptoms will be reported by the child's caregiver.|Average number of days, over 2 weeks, throughout the school year|||Days||Standard Deviation|Mean
823696|NCT01175473|Secondary|Percentages of Patients by Ranges of Oxyntomodulin Levels|Percentage of patients with oxyntomodulin level less than or equal to (<=) limit of detection (LOD), above limit of quantification (LOQ) and between LOD and LOQ were reported. The LOD and LOQ values for oxyntomodulin were 70 and 200 picogram per milliliter (pg/mL) respectively.|0.5 (8:00 clock time; prior to standardized breakfast), 2.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 2.5, 4.5 hours post study drug administration on Day 28|PD population. Here, 'n' signifies patients with oxyntomodulin assessment at the specified time point.||percentage of participants|||Number
823697|NCT01175473|Secondary|Change From Time-matched Baseline in Obestatin Concentration at Day 28|Change was calculated by subtracting time-matched baseline value from Day 28 value. Baseline value was the Day -1 time-matched obestatin assessment.|0.5 (8:00 clock time; prior to standardized breakfast), 2.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 2.5, 4.5 hours post study drug administration on Day 28|PD population.||nmol/L||Standard Deviation|Mean
823698|NCT01175473|Secondary|Change From Time-matched Baseline in Peptide YY3-36 (PYY3-36) Concentration at Day 28|Change was calculated by subtracting time-matched baseline value from Day 28 value. Baseline value was the Day -1 time-matched PYY-36 assessment.|0.5 (8:00 clock time; prior to standardized breakfast), 2.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 2.5, 4.5 hours post study drug administration on Day 28|PD population.||pmol/L||Standard Deviation|Mean
823699|NCT01175473|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 29|Change = HbA1c value at Day 29 (24 hours post-dose on Day 28) minus HbA1c value at baseline (pre-dose [Hour 0] on Day 1).|Pre-dose (Hour 0) on Day 1 and 29 (that is, 24 hours post-dose on Day 28)|PD population. Here, number of patients analyzed = patients with post-baseline HbA1c assessment.||percentage of hemoglobin||95% Confidence Interval|Least Squares Mean
823700|NCT01175473|Secondary|Change From Baseline in Glucagon AUC(0:30-4:30h) at Day 28|The area under the glucagon concentration time curve (AUC0:30-4:30h) was calculated using the linear trapezoidal rule from time of breakfast start (30 minutes after study drug administration [time: 0.5 hours] on Day 28) to 4 hours after breakfast start (time: 4.5 hours) and corrected by subtracting pre-breakfast glucagon concentration (time: 0.5 hours). Glucagon AUC0:30-4:30h on Day -1 was the baseline. Change in glucagon AUC0:30-4:30h = glucagon AUC0:30-4:30h on Day 28 minus glucagon AUC0:30-4:30h on Day -1.|0.5 (8:00 clock time; prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours post study drug administration on Day 28|PD population.||h*pg/mL||95% Confidence Interval|Least Squares Mean
823701|NCT01175473|Secondary|Change From Baseline in C-Peptide AUC(0:30-4:30h) at Day 28|The area under the C-peptide concentration time curve (AUC0:30-4:30h) was calculated using the linear trapezoidal rule from time of breakfast start (30 minutes after study drug administration [time: 0.5 hours] on Day 28) to 4 hours after breakfast start (time: 4.5 hours) and corrected by subtracting pre-breakfast C-peptide concentration (time: 0.5 hours). C-peptide AUC0:30-4:30h on Day -1 was the baseline. Change in C-peptide AUC0:30-4:30h = C-peptide AUC0:30-4:30h on Day 28 minus C-peptide AUC0:30-4:30h on Day -1.|0.5 (8:00 clock time; prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours post study drug administration on Day 28|PD population.||h*ng/mL||95% Confidence Interval|Least Squares Mean
823702|NCT01175473|Secondary|Change From Baseline in Insulin AUC(0:30-4:30h) at Day 28|The area under the insulin concentration time curve (AUC0:30-4:30h) was calculated using the linear trapezoidal rule from time of breakfast start (30 minutes after study drug administration [time: 0.5 hours] on Day 28) to 4 hours after breakfast start (time: 4.5 hours) and corrected by subtracting pre-breakfast insulin concentration (time: 0.5 hours). Insulin AUC0:30-4:30h on Day -1 was the baseline. Change in insulin AUC0:30-4:30h = insulin AUC0:30-4:30h on Day 28 minus insulin AUC0:30-4:30h on Day -1.|0.5 (8:00 clock time; prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours post study drug administration on Day 28|PD population.||hour*micro international unit/milliliter||95% Confidence Interval|Least Squares Mean
823703|NCT01175473|Secondary|Change From Baseline in Pro-insulin AUC(0:30-4:30h) at Day 28|The area under the pro-insulin concentration time curve (AUC0:30-4:30h) was calculated using the linear trapezoidal rule from time of breakfast start (30 minutes after study drug administration [time: 0.5 hours] on Day 28) to 4 hours after breakfast start (time: 4.5 hours) and corrected by subtracting pre-breakfast pro-insulin concentration (time: 0.5 hours). Pro-insulin AUC0:30-4:30h on Day -1 was the baseline. Change in pro-insulin AUC0:30-4:30h = pro-insulin AUC0:30-4:30h on Day 28 minus pro-insulin AUC0:30-4:30h on Day -1.|0.5 (8:00 clock time; prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours post study drug administration on Day 28|PD population.||hour*micro international unit/milliliter||95% Confidence Interval|Least Squares Mean
823704|NCT01175473|Secondary|Change From Baseline in Postprandial Plasma Glucose (PPG) Excursion at Day 28|PPG excursion was determined on Day -1 (Baseline) and 28 as the maximum change in PPG from time of breakfast start (time: 0.5 hours) until 4 hours later subtracted from pre-meal plasma concentration.|0.5 (8:00 clock time; prior to standardized breakfast), 0.75, 1, 1.5, 2, 2.5, 3.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 0.75, 1, 1.5, 2, 2.5, 3.5, 4.5 hours post study drug administration on Day 28|PD population.||mg/dL||95% Confidence Interval|Least Squares Mean
823705|NCT01175473|Primary|Change From Baseline in Area Under the Plasma Glucose Concentration Curve From Time 0.5 Hours to 4.5 Hours (GLU-AUC0:30-4:30h) at Day 28|The area under the plasma glucose concentration time curve (GLU-AUC0:30-4:30h) was calculated using the linear trapezoidal rule from time of breakfast start (30 minutes after study drug administration [time: 0.5 hours] on Day 28) to 4 hours after breakfast start (time: 4.5 hours) and corrected by subtracting pre-breakfast plasma glucose concentration (time: 0.5 hours). GLU-AUC0:30-4:30h on Day -1 was the baseline. Change in GLU-AUC0:30-4:30h = GLU-AUC0:30-4:30h on Day 28 minus GLU-AUC0:30-4:30h on Day -1.|0.5 (8:00 clock time; prior to standardized breakfast), 0.75, 1, 1.5, 2, 2.5, 3.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 0.75, 1, 1.5, 2, 2.5, 3.5, 4.5 hours post study drug administration on Day 28|Pharmacodynamic (PD) population (modified intent-to-treat [mITT] population) included all randomized patients, who received at least 1 dose of lixisenatide or liraglutide, and had both a baseline assessment and at least 1 post-baseline assessment of any pharmacodynamic variable, irrespective of compliance with the study protocol and procedures.||h*mg/dL||95% Confidence Interval|Least Squares Mean
823706|NCT01175590|Secondary|Individual Clinical Outcomes - Bulbar Injection|Bulbar conjunctival injection measured as normal, mild, moderate or severe|At day 11 (Vist 3)|Baseline-Designated Study Eye (Modified Intent-to- Treat Population)||eyes|Participants||Number
823707|NCT01175590|Secondary|Individual Clinical Outcomes - Bulbar Injection|Bulbar conjunctival injection measured as normal, mild, moderate or severe|At day 8 (Vist 2)|Baseline-Designated Study Eye (Modified Intent-to- Treat Population)||eyes|Participants||Number
823708|NCT01175590|Secondary|Individual Clinical Outcomes - Bulbar Injection|Bulbar conjunctival injection measured as normal, mild, moderate or severe|At day 1 (Vist 1)|Baseline-Designated Study Eye (Modified Intent-to- Treat Population)||eyes|Participants||Number
823709|NCT01175590|Secondary|Individual Clinical Outcomes - Ocular Discharge|ocular conjunctival discharge measured as absent, mild, moderate or severe|At day 11 (Vist 3)|Baseline-Designated Study Eye (Modified Intent-to- Treat Population)||eyes|Participants||Number
823710|NCT01175590|Secondary|Individual Clinical Outcomes - Ocular Discharge|ocular conjunctival discharge measured as absent, mild, moderate or severe|At day 8 (Vist 2)|Baseline-Designated Study Eye (Modified Intent-to- Treat Population)||eyes|Participants||Number
823711|NCT01175590|Secondary|Individual Clinical Outcomes - Ocular Discharge|ocular conjunctival discharge measured as absent, mild, moderate or severe|At day 1 (Vist 1)|Baseline-Designated Study Eye (Modified Intent-to- Treat Population)||eyes|Participants||Number
823712|NCT01175590|Secondary|Microbial Outcome With Clinical Resolution|At each follow-up visit for the accepted ocular bacterial species that were present at or above threshold at baseline|Day 11 (Visit 3)|Modified Intent-to-Treat Population||eyes|Participants||Number
823713|NCT01175590|Secondary|Microbial Outcome With Clinical Resolution|At each follow-up visit for the accepted ocular bacterial species that were present at or above threshold at baseline|Day 8 (Visit 2)|Modified Intent-to-Treat Population||eyes|||Number
823714|NCT01175590|Primary|Non-Ocular Treatment-Emergent Adverse Events|Non-Ocular Treatment-Emergent Adverse Events on the Study Eye|7 days|Safety Population||Events|||Number
823715|NCT01175590|Secondary|Microbial Eradication|The absence of all accepted ocular bacterial species that were present at or above threshold at baseline, after seven days of treatment.|Days 11 (Visit 3)|Study Eye, Modified Intent-to-Treat Population||eyes|Participants||Number
823716|NCT01175590|Secondary|Microbial Eradication|The absence of all accepted ocular bacterial species that were present at or above threshold at baseline, after seven days of treatment.|Days 8 (Visit 2)|Study Eye, Modified Intent-to-Treat Population||eyes|Participants||Number
823717|NCT01175590|Secondary|Clinical Resolution|The absence of both conjunctival discharge and bulbar conjunctival injection, after seven days of treatment.|Day 11 (Visit 3)|Study eye for the mITT population||eyes|||Number
823718|NCT01175590|Secondary|Clinical Resolution|The absence of both conjunctival discharge and bulbar conjunctival injection, after seven days of treatment. Participants with non-missing data|Day 8 (Visit 2)|Study eye for the mITT population||eyes|Participants||Number
823719|NCT01175590|Primary|Ocular Treatment Emergent Adverse Events|Ocular Treatment-Emergent Adverse Events on the Study Eye|At each visit - 7 days|Safety Population||Events|Participants||Number
823720|NCT01175668|Secondary|Total Dose of NMS Used||For the duration of treatment, upto 3 months|||mg/kg||95% Confidence Interval|Mean
823721|NCT01175668|Primary|Length of Treatment With Neonatal Morphine Sulfate||subjects were followed for the duration of treatment, up to 3 months|||days||95% Confidence Interval|Mean
823722|NCT01175707|Secondary|Health Economic Outcomes in United States (US) Dollars for Home Infusion Therapy Per Participant|Total Heartland costs per participant were derived by summing the costs of drug, pharmacy services/supplies and nursing.|Day 1 up to Day 14|All study participants.||US Dollars||Standard Deviation|Mean
823723|NCT01175707|Secondary|Number of Laboratory Assessment Types During Home Infusion Therapy|There may be more than one type of laboratory assessment per participant. A participant is counted only once for each category. Laboratory assessments include serum creatinine, creatine phosphokinase (CPK), and vancomycin trough|Day 1 up to Day 14|All study participants.||Assessments|||Number
823724|NCT01175707|Secondary|Mean Number of Laboratory Assessments Per Participant During Home Infusion Therapy|Laboratory assessments include serum creatinine, creatine phosphokinase (CPK), and vancomycin trough.|Day 1 up to Day 14|All study participants.||Assessments||Standard Deviation|Mean
823725|NCT01175707|Secondary|Participants Who Had More Than 1 Laboratory Assessment During Home Infusion Therapy|Laboratory assessments include serum creatinine, creatine phosphokinase (CPK), and Vancomycin trough.|Day 1 up to Day 14|All study participants.||Participants|||Number
823726|NCT01175707|Secondary|Number of Intervention Types During Home Infusion Therapy|There may be more than one type of intervention per participant. A participant is counted only once for each category even if they had several instances of a given intervention.|Day 1 up to Day 14|All study participants||participants|||Number
823727|NCT01175707|Secondary|Mean Number of Interventions Per Participant During Home Infusion Therapy|Type of interventions include IV line replacement, IV line removal, IV line placement (post study therapy), incision and drainage (wound), incision and drainage (line), debridement, declotting procedure, and blood draw.|Day 1 up to Day 14|All study participants.||Interventions||Standard Deviation|Mean
823728|NCT01175707|Secondary|Number of Participants With at Least 1 Intervention Related to Complicated Skin or Skin Structure Infection (cSSSI) During Home Infusion Therapy|Type of interventions include Intravenous (IV) line replacement, IV line removal, IV line placement (post study therapy), Incision and drainage (wound), Incision and drainage (line), Debridement, Declotting procedure, and Blood draw.|Day 1 up to Day 14|All study participants.||Participants|||Number
823729|NCT01175707|Primary|Percentage of Treatment Goals Met at End of Therapy|"Treatment goals included: 1. Elimination of infection/achieved desired response. 2. Laboratory values were within normal limits or improved indicating progress toward therapy goal. 3. Pain was controlled. 4. Participant did not have catheter site complications (eg,infection, loss of patency). 5. Participant had no knowledge deficits related to administration, equipment use, side effects and waste disposal. 6. Participant had no side effects, adverse drug reactions and/or drug or food interactions. 7. Signs and symptoms of infection did improve or resolve. 8. Participant was compliant with IV therapy 9. Successfully completed therapy without interruptions, unexpected hospitalizations. 10. Participant continued on an oral antibiotic. 11. Participant continued on an IV antibiotic.
Each participant’s percentage was derived from number of treatment goals achieved out of a maximum of 11 goals. Reported percentage below is the average of all participants’ percentage of goals met by arm."|Day 1 up to Day 14|All study participants.||Percentage of Goals Met||Standard Deviation|Mean
823730|NCT01175707|Primary|Reasons for Pharmacist Consultations During Home Infusion Therapy|The reason for a participant’s pharmacist consultation is presented. There may be more than one reason for pharmacist consultations per participant.|Day 1 up to Day 14|All study participants.||Reason Cited|||Number
823731|NCT01175707|Primary|Reasons for Nurse Visits During Home Infusion Therapy|The reason for a participant’s nurse visit is presented. There may be more than one reason for nurse visits per participant.|Day 1 up to Day 14|All study participants.||Reason Cited|||Number
823732|NCT01175707|Primary|Number of Participants With at Least One Pharmacist Consultation During Home Infusion Therapy||Day 1 up to Day 14|All study participants.||Participants|||Number
823733|NCT01175707|Primary|Number of Participants With at Least 1 Unscheduled Nursing Visit During Home Infusion Therapy||Day 1 up to Day 14|Number of Participants Analyzed based on number of participants with at least one nurse visit/pharmacist consultation within each treatment group results in 39 participants analyzed for the Daptomycin ARM group for this Outcome Measure.||Participants|||Number
823734|NCT01175707|Primary|Number of Nurse Visits or Consultations Per Participant for Home Infusion Therapy|Each participant is counted once per category.|Day 1 up to Day 14|All study participants.||Visits or Consultations per Participant||Standard Deviation|Mean
823735|NCT01175707|Primary|Total Antibiotic Therapy Duration (in Days) Per Participant for Home Infusion Therapy|The mean duration in home-infusion antibiotic therapy per participant is presented.|Day 1 up to Day 14|All study participants.||Days||Standard Deviation|Mean
823736|NCT01175707|Primary|Time Spent (Minutes) for Home Infusion Therapy|Each participant is counted once per category. Avg=average; Admin=administer.|Day 1 up to Day 14|All study participants.||Minutes||Standard Deviation|Mean
823737|NCT01175798|Secondary|Change in Immune Parameters|Secondary outcomes to be measured include change in peripheral blood mononuclear cell (PBMC) profile by flow cytometry at 6 and 12 months, change in ELISPOT-based panel of reactive T cell (PRT) readout at 6 and 12 months, change in PMBC cytokine production in response to toll-like-receptor stimulation at 6 and 12 months, and response to influenza vaccination.|1 year||||||
823738|NCT01175798|Primary|Change in 25OH-Vitamin D Level|Vitamin D deficient study subjects will be randomized to either treatment with 50,000 IU oral 25OH-Vit D weekly or no treatment (standard of care). The primary outcome of change in 25OH-Vit D level will be measured at 6 weeks, 3 months, 6 months, and 12 months.|1 year|||ng/dL||Inter-Quartile Range|Median
823739|NCT01175811|Secondary|Percentage of Participants Experiencing a Severe Hypoglycemic Episode|Severe hypoglycemic episode is defined as any event requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. The percentage of participants experiencing a severe hypoglycemic episode is defined as the 100 multiplied by the number of participants experiencing a severe hypoglycemic episode divided by the number of participants exposed to study drug.|baseline through 24 weeks|Participants in the safety analyses population: participants who had been randomized and received at least one dose of study drug.||Percentage of participants|||Number
823740|NCT01175811|Secondary|The Rate of Hypoglycemic Episodes|The rate of hypoglycemic episodes is defined as the mean number of hypoglycemic episodes per 30 days per participant. Hypoglycemic episodes are defined as an event which is associated with reported signs and symptoms of hypoglycemia, and/or a documented blood glucose (BG) concentration of <= 70 mg/dL (3.9 mmol/L).|baseline through 24 weeks|Participants in the safety analyses population: participants who had been randomized and received at least one dose of study drug.||hypoglycemic episode/30 days/participant||Standard Error|Mean
823741|NCT01175811|Secondary|Percentage of Participants With Hypoglycemic Episodes (Incidence)|Incidence of hypoglycemic episodes is defined as 100 multiplied by the number of participants experiencing a hypoglycemic episode divided by the number of participants exposed to study drug. Hypoglycemic episodes are defined as an event which is associated with reported signs and symptoms of hypoglycemia, and/or a documented blood glucose (BG) concentration of <= 70 mg/dL (3.9 mmol/L).|baseline through 24 weeks|Participants in the safety analyses population: participants who had been randomized and received at least one dose of study drug.||percentage of participants|||Number
823742|NCT01175811|Secondary|Daily Dose of Insulin Per Kilogram of Body Weight: Total, Basal and Prandial||24 weeks|Participants in the intent-to-treat population: participants who had been randomized and received at least one dose of study drug. Last observation carried forward (LOCF) principle was used.||International Units per kilogram (IU/kg)||Standard Deviation|Mean
823780|NCT01175850|Primary|Primary Safety Composite|Primary safety composite is defined as freedom from death through 30 days or target limb major amputation or clinically-driven target vessel revascularization (CD-TVR) within 12 months post index procedure.|12 month|Intention-to-Treat (ITT) (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.||Percentage of Participants|||Number
823743|NCT01175811|Secondary|Change in Body Mass Index (BMI) From Baseline to 12 and 24 Weeks|Body mass index is an estimate of body fat based on body weight divided by height squared. Least Squares (LS) means are calculated using mixed model repeating measures (MMRM) using change from baseline in BMI at all post baseline measurement as dependent variables, treatment, country, visit and treatment by visit interaction as fixed effects, baseline BMI value as a covariate and participants as a random effect.|Baseline, 12 weeks, and 24 weeks|Participants in the intent-to-treat population: participants who had been randomized and received at least one dose of study drug and had baseline and at least 1 post-baseline BMI data.||kilogram per square meter (kg/m^2)||95% Confidence Interval|Least Squares Mean
823744|NCT01175811|Secondary|Daily Dose of Insulin: Total, Basal, and Prandial||24 weeks|Participants in the intent-to-treat population: participants who had been randomized and received at least one dose of study drug. Last observation carried forward (LOCF) principle was used.||International Units (IU)||Standard Deviation|Mean
823745|NCT01175811|Secondary|The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks.|7-point Self-monitored Blood Glucose (SMBG) Profiles are measures of blood glucose taken 7 times a day at the morning pre-meal, morning 2-hours post-meal, midday pre-meal, midday 2-hours post-meal, evening pre-meal, evening 2-hours post-meal, and 0300 hour [3 am]. Each participant took measures on 3 non-consecutive days and the average was calculated for each of the 7 time points. The mean of the 7-point averages was calculated for all the participants at baseline, Weeks 12 and 24.|Baseline, 12 weeks, and 24 weeks|Participants in the intent-to-treat population: participants who had been randomized and received at least one dose of study drug||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
823746|NCT01175811|Secondary|The Percentage of Participants Who Achieved Haemoglobin A1c (HbA1c) Less Than or Equal to 6.5% and Less Than or Equal to 7% at 12 Weeks and 24 Weeks|The Percentage of participants achieving a haemoglobin A1c (HbA1c) less than or equal (<=) to 6.5% or 7% is defined as 100 multiplied by the number of participants with a HbA1c of the cut-off value (6% or 7%) divided by the number of participants exposed to study drug. Participants with missing HbA1c values at endpoint were treated as not achieving the HbA1c goal.|12 weeks, 24 weeks|Participants in the intent-to-treat population: participants who had been randomized and received at least one dose of study.||Percentage of participants|||Number
823747|NCT01175811|Secondary|Change in HbA1c From Baseline to 12 Week Endpoint|Least Squares (LS) means are calculated using mixed model repeating measures (MMRM) with the change from baseline in HbA1c at all post baseline measurement as dependent variables, treatment, country, visit and treatment by visit interaction as fixed effects, baseline HbA1c value as a covariate and participant as a random effect.|Baseline, 12 weeks|Participants in the intent-to-treat population: participants who had been randomized and received at least one dose of study drug and who had a baseline and at least 1 post-baseline evaluable HbA1c data.||percent HbA1c||95% Confidence Interval|Least Squares Mean
823748|NCT01175811|Primary|Change in Haemoglobin A1c (HbA1c) From Baseline to 24 Week Endpoint|Least Squares (LS) means are calculated using mixed model repeating measures (MMRM) with the change from baseline in HbA1c at all post baseline measurement as dependent variables, treatment, country, visit and treatment by visit interaction as fixed effects, baseline HbA1c value as a covariate and participant as a random effect.|Baseline, 24 weeks|Participants in the intent-to-treat population: participants who had been randomized and received at least one dose of study drug and had at least 1 post-baseline evaluable HbA1c data.||percent HbA1c||95% Confidence Interval|Least Squares Mean
823749|NCT01175824|Primary|Change in HbA1c From Baseline to 24 Weeks Endpoint (Intention-to-Treat Population)|The change from baseline to 24 weeks in the percentage of glycosylated hemoglobin A1c (HbA1c) in plasma. The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included baseline HbA1c concentration as a covariate, treatment, country, week of visit, and treatment-by-week interaction as fixed effects, and participant and error as random effects.|Baseline, 24 weeks|Intention-to-treat population (ITT): randomized participants who received at least 1 dose of study drug and had HbA1c data at 24 weeks. Participants were analyzed per their assigned treatment arm regardless of the treatment they actually received.||percentage of HbA1c||95% Confidence Interval|Least Squares Mean
823750|NCT01175824|Secondary|The Number of Participants With Severe Hypoglycemic Episodes|The number of participants who had a severe hypoglycemic episode anytime during the study. Severe hypoglycemia was defined as any event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.|Baseline through 24 weeks|Safety population: randomized participants who took at least 1 dose of study drug.||participants|||Number
823751|NCT01175824|Secondary|The Rate of Hypoglycemic Episodes|The hypoglycemia rate per 30 days was calculated as the number of episodes reported for the interval between visits and during the study divided by the number of days in the given interval and multiplied by 30.|Baseline through 24 weeks|Safety population: randomized participants who took at least 1 dose of study drug.||hypoglycemic episodes per 30 day period||Standard Deviation|Mean
823752|NCT01175824|Secondary|Perceptions About Medications-Diabetes 21 (PAM-D21) Questionnaire Score at 24 Weeks|PAM-D21 is a validated questionnaire consisting of 21 items to assess a participant's perceptions about their diabetes treatment regimens and perceived emotional and physical side-effects. The PAM-D21 consists of 4 subscales: Convenience/Flexibility (items 1 to 3); Perceived Effectiveness (items 4 to 6); Emotional Effects (items 7 to 11); and Physical Effects (items 12 to 21). Item scores range from 1 (none of the time) to 4 (all of the time). Subscale scores were linearly transformed to a 0-100, with higher score corresponds to better perceptions about diabetes medications. The least squares (LS) mean was estimated from an analysis of covariance (ANCOVA) model that included baseline score as a covariate and treatment, glycosylated hemoglobin A1c (HbA1c) stratum, and country as fixed effects.|24 weeks|Randomized participants who received at least 1 dose of study drug and had PAM-D21 scores at 24 weeks.||units on a scale||95% Confidence Interval|Least Squares Mean
823781|NCT01175850|Primary|Primary Patency|Primary patency is defined as freedom from clinically-driven target lesion revascularization (TLR) or restenosis as determined by duplex ultrasound (DUS) Peak Systolic Velocity Ratio (PSVR) ≤ 2.4.|12 Month|Intention-to-Treat (ITT) (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.||Percentage of participants|||Number
823782|NCT01175902|Secondary|OPP, Period 2|"OPP was calculated according to the following formula:
OPP=(1/3 systolic BP + 2/3 diastolic BP) x 2/3 -IOP, diastolic OPP (DOPP)=diastolic BP-IOP
OPP after treaemt from week 8 to week 12"|12 weeks|||mmHg||Standard Deviation|Mean
823753|NCT01175824|Secondary|Insulin Treatment Satisfaction Questionnaire (ITSQ) Score at 24 Weeks|ITSQ: validated instrument containing 22 items which are measured on a 7-point scale: 1 (no bother at all) to 7 (a tremendous bother) used to assess insulin treatment satisfaction. Items are divided into 5 domains: Inconvenience of Regimen (5 items: domain score range 5 to 35), Lifestyle Flexibility (3 items: domain score range 3 to 21), Glycemic Control (3 items: domain score range 3 to 21), Hypoglycemic Control (5 items: domain score range 5 to 35), Insulin Delivery Device (6 items: domain score range 6 to 42) lower scores reflect better outcome. ITSQ Total Overall Score ranged from 22 to 154. Raw domain scores transformed on 0-100 scale, where transformed domain score = 100×[(7-raw domain score)/6]. Higher scores indicate better treatment satisfaction. Least squares (LS) mean estimated from analysis of covariance (ANCOVA) model that included baseline score as covariate and treatment, glycosylated hemoglobin A1c (HbA1c) stratum, and country as fixed effects.|24 weeks|Randomized participants who received at least 1 dose of study drug and had ITSQ scores at 24 weeks. Last observation carried forward (LOCF).||units on a scale||95% Confidence Interval|Least Squares Mean
823754|NCT01175824|Secondary|The Number of Participants With a Hypoglycemic Episodes (Incidence)|A hypoglycemic episode was defined as an event associated with 1) reported signs and symptoms of hypoglycemia, and/or 2) a documented blood glucose (BG) concentration of <= 70 milligrams per deciliter [mg/dL, 3.9 millimoles per liter (mmol/L)].|Baseline through 24 weeks|Safety population: randomized participants who took at least 1 dose of study drug.||participants|||Number
823755|NCT01175824|Secondary|Change in Weight From Baseline to 12 Weeks and 24 Weeks|The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included baseline weight as a covariate, treatment, country, baseline glycosylated hemoglobin A1c (HbA1c) stratification level, week of visit, and the treatment-by-week interaction as fixed effects, and participant and error as random effects.|Baseline, 12 weeks, 24 weeks|Safety population: randomized participants who took at least 1 dose of study drug and had evaluable body weight data at the specified time points.||kilograms (kg)||95% Confidence Interval|Least Squares Mean
823756|NCT01175824|Secondary|Daily Insulin Dose: Total, Basal, and Prandial at 12 Weeks and 24 Weeks||12 weeks, 24 weeks|Intention-to-treat population (ITT): randomized participants who received at least 1 dose of study drug and had dosing data at the specified time points. Participants were analyzed per their assigned treatment arm regardless of the treatment they actually received.||international units (IU)||Standard Deviation|Mean
823757|NCT01175824|Secondary|Glycemic Variability From the 7-point Self-Monitored Blood Glucose (SMBG) Profiles at 12 Weeks and 24 Weeks|The 7-point SMBG profile was calculated as the average blood glucose concentration across the 7 pre-specified time points in a day that was then averaged over 3 non-consecutive days in the 2 weeks prior to the 12 week visit and 24 week visit. Glycemic variability was calculated as the standard deviation of the 7-point SMBG profiles. Standard deviation was first calculated for each day and then averaged over 3 non-consecutive days for each visit. The least squares (LS) mean was estimated from mixed-effects model with repeated measures that included the baseline value of the variable as a covariate, treatment, country, baseline glycosylated hemoglobin A1c (HbA1c)stratification level, week of visit, and treatment-by-week interaction as fixed effects, and participant and error as random effects.|12 weeks, 24 weeks|Intention-to-treat population (ITT): randomized participants who received at least 1 dose of study drug and had SMBG glycemic variability data at the specified time points. Participants were analyzed per their assigned treatment arm regardless of the treatment they actually received.||millimoles/liter (mmol/L)||95% Confidence Interval|Least Squares Mean
823758|NCT01175824|Secondary|7-point Self-Monitored Blood Glucose (SMBG) Profiles at 12 Weeks and 24 Weeks|7-point Self-monitored Blood Glucose (SMBG) Profiles are measures of blood glucose taken 7 times a day at the morning pre-meal, morning 2-hours post-meal, midday pre-meal, midday 2-hours post-meal, evening pre-meal, evening 2-hours post-meal, and 0300 hour [3 am]. Each participant took measures on 3 non-consecutive days and the average was calculated for each of the 7 time points. The mean of the 7-point averages was calculated for all the participants at baseline, Weeks 12 and 24. The least squares (LS) mean was estimated from mixed-effects model with repeated measures that included the baseline value of the variable as a covariate, treatment, country, baseline glycosylated hemoglobin A1c (HbA1c)stratification level, week of visit, and treatment-by-week interaction as fixed effects, and participant and error as random effects.|12 weeks, 24 weeks|Intention-to-treat population (ITT): randomized participants who received at least 1 dose of study drug and had SMBG data at the specified time points. Participants were analyzed per their assigned treatment arm regardless of the treatment they actually received.||millimoles per liter (mmol/L)||95% Confidence Interval|Least Squares Mean
823759|NCT01175824|Secondary|Change in the Fasting Plasma Glucose Concentration From Baseline to 12 Weeks and 24 Weeks|The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included baseline fasting plasma glucose value as a covariate, treatment, country, baseline HbA1c stratification level, week of visit, and treatment-by-week interaction as fixed effects, and participant and error as random effects.|Baseline, 12 weeks, and 24 weeks|Intention-to-treat population (ITT): randomized participants who received at least 1 dose of study drug and had fasting plasma glucose concentration data at the specified time points. Participants were analyzed per their assigned treatment arm regardless of the treatment they actually received.||millimoles per liter (mmol/L)||95% Confidence Interval|Least Squares Mean
823760|NCT01175824|Secondary|Number of Participants Who Achieve a Target HbA1c Concentration of Less Than 7% or Less Than or Equal to 6.5% at 24 Weeks||24 weeks|Intention-to-treat population (ITT): randomized participants who received at least 1 dose of study drug and had HbA1c data at 24 weeks. Participants were analyzed per their assigned treatment arm regardless of the treatment they actually received.||participants|||Number
823761|NCT01175824|Secondary|Change in the HbA1c Concentration From Baseline to 12 Weeks Endpoint|The change from baseline to 12 weeks in the percentage of glycosylated hemoglobin A1c (HbA1c) in plasma. The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included baseline HbA1c concentration as a covariate, treatment, country, week of visit, and treatment-by-week interaction as fixed effects, and participant and error as random effects.|Baseline, 12 weeks|Intention-to-treat population (ITT): randomized participants who received at least 1 dose of study drug and had HbA1c data at the 12 weeks. Participants were analyzed per their assigned treatment arm regardless of the treatment they actually received.||percentage of HbA1c||95% Confidence Interval|Least Squares Mean
823762|NCT01175824|Primary|Change in HbA1c From Baseline to 24 Weeks Endpoint (Per Protocol Population)|The change from baseline to 24 weeks in the percentage of glycosylated hemoglobin A1c (HbA1c) in plasma. The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included baseline HbA1c concentration as a covariate, treatment, country, week of visit, and treatment-by-week interaction as fixed effects, and participant and error as random effects.|Baseline, 24 weeks|Per protocol population: randomized participants with the exception of participants who did not complete Week 24 visit, received study drug different from their randomized study treatment, violated any of the inclusion, exclusion, or discontinuation criteria, or were significantly noncompliant.||percentage of HbA1c||95% Confidence Interval|Least Squares Mean
823763|NCT01175850|Secondary|Days of Hospitalization Due to the Index Lesion|Days of hospitalization from procedure through 12 month.|12 month|Intention-to-Treat (ITT) (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.||Days||Standard Deviation|Mean
823764|NCT01175850|Secondary|Clinical Success|Clinical success is defined as procedural success without procedural complications (death, stroke, major target limb amputation, thrombosis of the target lesion, or target vessel revascularization (TVR)) prior to discharge.|Day 1|Intention-to-Treat (ITT) (n=331)||Percentage of participants|||Number
823765|NCT01175850|Secondary|Procedural Success|Procedural success is defined as obtainment of ≤30% residual stenosis by visual estimate (with or without stenting)|Day 1|Intention-to-Treat (ITT) (n=331)||Percentage of participants|||Number
823766|NCT01175850|Secondary|Device Success|Device success is defined as successful delivery, balloon inflation and deflation and retrieval of the intact study device without burst below rated burst pressure (RBP).|Day 1|Total number of devices used in the ITT population (n=331).||Percentage of devices|Devices||Number
823767|NCT01175850|Secondary|Change From Baseline in Walking Capacity Assessment by Walking Impairment Questionnaire (WIQ) at 12 Months|"Walking capacity assessment by WIQ at 1 year compared to baseline. WIQ is a quality of life questionnaire that was specifically designed to assess the degree of impairment experienced by patients with claudication.
Clinical outcomes were assessed by patients responses to question 1A. Question 1A is specific for calf or buttocks claudication and is used to create a summary score for analysis. Question 1A is expressed on a scale of 0% (unable to perform because of severe claudication) to 100% (no impairment)."|12 month|Intention-to-Treat (ITT) (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.||Units on a scale||Standard Deviation|Mean
823768|NCT01175850|Secondary|Change From Baseline in Quality of Life Assessment by EuroQol Group 5-Dimension Self Report Questionnaire (EQ5D) at Month 12|"Quality of life assessment by EQ5D at 1 year compared to baseline. EQ5D is a standardised measure of health status and economic appraisal. The EQ5D consists of the EQ5D descriptive system which comprises the following variables for the 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: (1) no problems, (2) some problems, (3) extreme problems. A complex algorithm that took individual dimensions and generated an overall score was used.
EQ5D health state is used in the algorithm to calculate an overall score where - 0.109 = 'worst possible outcome' and 1.000 = 'best possible outcome'."|Baseline to 12 month|Intention-to-Treat (ITT) (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.||Units on a scale||Standard Deviation|Mean
823769|NCT01175850|Secondary|Duplex-defined Binary Restenosis (Peak Systolic Velocity Ratio >3.4).||12 month|Intention-to-Treat (ITT) (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.||Percentage of particpants|||Number
823770|NCT01175850|Secondary|Duplex-defined Binary Restenosis (Peak Systolic Velocity Ratio (PSVR) >2.4).|Duplex ultrasound measurement that measures the peak systolic velocity of blood (cm/sec) within a lesion divided by the peak velocity of blood (cm/sec) proximal to the lesion.|12 month|Intention-to-Treat (ITT) (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.||Percentage of participants|||Number
823771|NCT01175850|Secondary|Secondary Sustained Clinical Improvement|Freedom from target limb amputation and increase in Rutherford class.|12 month|Intention-to-Treat (ITT) (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.||percentage of participants|||Number
823772|NCT01175850|Secondary|Primary Sustained Clinical Improvement|Freedom from target limb amputation, target vessel revascularization (TVR), and increase in Rutherford class. Rutherford classification is a clinical staging system that is used to describe peripheral arterial disease.|12 month|Intention-to-Treat (ITT) (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.||percentage of particpants|||Number
823773|NCT01175850|Secondary|Thrombosis at the Target Lesion||12 month|Intention-to-Treat (ITT) (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.||Percentage of participants|||Number
823774|NCT01175850|Secondary|Major Target Limb Amputation||12 month|Intention-to-Treat (ITT) (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.||percentage of amputations|||Number
823775|NCT01175850|Secondary|Time to First Clinically Driven Target Lesion Revascularization (CD-TLR)|Clinically-driven target lesion revascularization (CD-TLR) is defined as any re-intervention within the target lesion due to symptoms or drop of ankle brachial index (ABI) of ≥20% or >0.15 when compared to post-procedure baseline.|12 month|Includes all subjects who experienced a CD-TLR.||Days||Standard Deviation|Mean
823776|NCT01175850|Secondary|Target Lesion Revascularization (TLR)||12 month|Intention-to-Treat (ITT) (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.||Percentage of participants|||Number
823777|NCT01175850|Secondary|Target Vessel Revascularization (TVR)||12 month|Intention-to-Treat (ITT) (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.||Percentage of participants|||Number
823778|NCT01175850|Secondary|All-cause Death||12 month|Intention-to-Treat (ITT) (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.||percentage of participants|||Number
823779|NCT01175850|Secondary|Major Adverse Events (MAE) Composite|Major Adverse Events (MAE) composite defined as all-cause death, clinically-driven target vessel revascularization (CD-TVR), major target limb amputation, thrombosis at the target lesion site|12 month|Intention-to-Treat (ITT) (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.||Percentage of participants|||Number
823783|NCT01175902|Secondary|Ocular Perfusion Pressure (OPP), Period 1|"OPP was calculated according to the following formula:
OPP=(1/3 systolic BP + 2/3 diastolic BP) x 2/3 -IOP, diastolic OPP (DOPP)=diastolic BP-IOP"|4 weeks|||mmHg||Standard Deviation|Mean
823788|NCT01176032|Secondary|Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Rate of Use of Added Antihypertensive Rescue Drugs|The rate of use of first and second antihypertensive rescue drugs added was also assessed at all visits after week 2. The rescue drug at week 10 and 18 for those patients not achieving the required BP was amlodipine, Patients who did not achieve the required BP at week 26 were treated with hydrochlorothiazide|Baseline, Week 10,18,26|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment||Patients|||Number
823789|NCT01176032|Secondary|Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Patients With SBP < 140 mmHg and DBP < 90 mmHg Compared to Baseline|The control rate was defined as the proportion of patients with SBP < 140 mmHg and DBP < 90 mmHg compared to baseline|Week10,18,26,36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment||Patients|||Number
823790|NCT01176032|Secondary|Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Patients With Satisfactory Response Rate|Response rate was defined as the proportion of patients with a satisfactory systolic BP response (SBP < 140 mmHg or reduction of ≥ 10 mmHg compared to baseline) and a satisfactory diastolic BP response (DBP < 90 mmHg or reduction of ≥ 5 mmHg compared to baseline)|Baseline, Week10,18,26,36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment||Patients|||Number
823791|NCT01176032|Secondary|Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Reduction in Diastolic Blood Pressure (DBP)|The mean systolic BP (SBP) and diastolic BP (DBP) readings for the aliskiren and losartan treatment groups, the difference in these values between the two groups and the comparison of post-baseline vs. baseline values|Baseline, Week 10,18,26,36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment||mmHg||Standard Deviation|Mean
823792|NCT01176032|Secondary|Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Reduction in Systolic Blood Pressure (SBP)|The mean systolic BP (SBP) and diastolic BP (DBP) readings for the aliskiren and losartan treatment groups, the difference in these values between the two groups and the comparison of post-baseline vs. baseline values|Baseline, Week 10,18,26,36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment||mmHg||Standard Deviation|Mean
823793|NCT01176032|Secondary|Change From Baseline of LVMI in Combination of Aliskiren With Amlodipine|Echocardiogram was performed at week 1 and at week 36. Reduction in LVMI is defined as the difference between the LVMI at the final visit and the baseline LVMI|Baseline, Week 36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment||g/m2||Standard Deviation|Mean
823794|NCT01176032|Secondary|Change From Baseline in Left Ventricular (LV) Function, Left Atrial Volume (Biplane Simpson's Method) in Combination of Aliskiren With Amlodipine|Reductions in the following measurements were analysed between the baseline visit and the final visit: left atrial volume (biplane Simpson's method)|Baseline, Week 36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.||cm3/m^2||Standard Deviation|Mean
823795|NCT01176032|Secondary|Change From Baseline in Left Ventricular (LV) Function, LA (Left Atrium) Diameter in Combination of Aliskiren With Amlodipine|Reductions in the following measurements were analysed between the baseline visit and the final visit: LA diameter|Baseline, Week 36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.||mm/m^2||Standard Deviation|Mean
823796|NCT01176032|Secondary|Change From Baseline in Left Ventricular (LV) Function, LV Ejection Fraction (Teicholz), and LV Ejection Fraction (Simpson) in Combination of Aliskiren With Amlodipine|Reductions in the following measurements were analysed between the baseline visit and the final visit: LV ejection fraction (Teicholz), and LV ejection fraction (Simpson)|Baseline, Week 36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.||Percent||Standard Deviation|Mean
823797|NCT01176032|Secondary|Change From Baseline in Left Ventricular (LV) Function, LV End-diastolic Volume by Simpson's Rule, and LV End-systolic Volume by Simpson's Rule in Combination of Aliskiren With Amlodipine|Reductions in the following measurements were analysed between the baseline visit and the final visit: LV end-diastolic volume by Simpson's rule, and LV end-systolic volume by Simpson's rule|Baseline, Week 36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.||ml||Standard Deviation|Mean
823798|NCT01176032|Secondary|Change From Baseline in Biomarker Such as Aldosterone (Aldo) in Heart Disease in Combination of Aliskiren With Amlodipine|The plasma level of biomarker parameter plasma aldosterone used to measure improvement in left ventricular (LV) function or reduction in left ventricular mass index (LVMI).|Baseline, Week 36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.||ng/dl||Standard Deviation|Mean
823820|NCT01176240|Secondary|306B Efficacy: Change in OHSA Item 1 From Baseline to Week 8 (Visit 7)|OHSA item 1 scale range: 0 (none) -10 (worst), likert scale. Change: score at Week 8 minus score at baseline. A negative score indicates an improvement in symptoms during the double-blind randomized phase relative to value at baseline.|Baseline, Week 8|The analysis was defined as those patients who completed 8 week of dosing and completed the visit 7 (8 week) efficacy evaluation. Patients who did not have week 8 efficacy data were excluded from the analysis. Of note, 2 patients completed the 8 week double blind study, but did not complete the efficacy evaluations at the final visit.||units on a scale||Standard Deviation|Mean
823799|NCT01176032|Secondary|Change From Baseline in Combination of Aliskiren With Amlodipine in Biomarkers of Heart Disease.|The plasma level of biomarkers parameters used to measure improvement in left ventricular (LV) function or reduction in left ventricular mass index (LVMI). The following biomarkers were analyzed: cardiotrophin-1 (CT-1), matrix metalloproteinase-1 (MMP-1); tissue inhibitor of MMPs (TIMP-1); annexin A5 (AnxA5); N-terminal prohormone of B-type natriuretic peptide (NT-proBNP)|Baseline, Week 36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.||ng/ml||Standard Deviation|Mean
823800|NCT01176032|Secondary|Change From Baseline in Reduction of Left Ventricular Mass Index (LVMI)|Echocardiogram was performed at week 1 and at week 36. Reduction in LVMI is defined as the difference between the LVMI at the final visit and the baseline LVMI|Baseline, Week 36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment||g/m^2||Standard Deviation|Mean
823801|NCT01176032|Secondary|Change From Baseline in Left Ventricular (LV) Function, Left Atrial Volume (Biplane Simpson's Method)|Reductions in the following measurements were analysed between the baseline visit and the final visit: left atrial volume (biplane Simpson's method)|Baseline, Week 36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.||cm3/m^2||Standard Deviation|Mean
823802|NCT01176032|Secondary|Change From Baseline in Left Ventricular (LV) Function, LA (Left Atrium) Diameter|Reductions in the following measurements were analysed between the baseline visit and the final visit: LA diameter|Baseline, Week 36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.||mm/m^2||Standard Deviation|Mean
823803|NCT01176032|Secondary|Change From Baseline in Left Ventricular (LV) Function, LV Ejection Fraction (Teicholz), and LV Ejection Fraction (Simpson)|Reductions in the following measurements were analysed between the baseline visit and the final visit: LV ejection fraction (Teicholz), and LV ejection fraction (Simpson)|Baseline, Week 36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.||Percent||Standard Deviation|Mean
823804|NCT01176032|Secondary|Change From Baseline in Left Ventricular (LV) Function, LV End-diastolic Volume by Simpson's Rule, and LV End-systolic Volume by Simpson's Rule|Reductions in the following measurements were analysed between the baseline visit and the final visit: LV end-diastolic volume by Simpson's rule, and LV end-systolic volume by Simpson's rule|Baseline, Week 36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.||ml||Standard Deviation|Mean
823805|NCT01176032|Secondary|Change From Baseline in Biomarker Such as Aldosterone (Aldo) in Heart Disease|The plasma level of biomarker parameter (aldosterone (Aldo)) used to measure improvement in left ventricular (LV) function or reduction in left ventricular mass index (LVMI)|Baseline, Week 36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.||ng/dl||Standard Deviation|Mean
823806|NCT01176032|Secondary|Change From Baseline in Biomarkers in Heart Disease|The plasma level of biomarkers parameters used to measure improvement in left ventricular (LV) function or reduction in left ventricular mass index (LVMI). The following biomarkers were analyzed: cardiotrophin-1 (CT-1), matrix metalloproteinase-1 (MMP-1); tissue inhibitor of MMPs (TIMP-1); annexin A5 (AnxA5); N-terminal prohormone of B-type natriuretic peptide (NT-proBNP)|Baseline, Week 36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.||ng/ml||Standard Deviation|Mean
823807|NCT01176032|Primary|Change From Baseline in C-terminal Propeptide of Procollagen Type I (PICP)|PICP is a measure of blood concentration of procollagen I carboxy-terminal propeptide (PICP), a peptide released from the myocardium when procollagen is converted to type I collagen. This biomarker exhibits good specificity and sensitivity for identifying myocardial fibrosis in hypertension.|Baseline, Week 36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment.||ug/l||Standard Deviation|Mean
823808|NCT01176058|Secondary|Number of Participants Who Died||Baseline to Day 52|Safety population: All participants who have received at least one dose of study medication.||participants|||Number
823809|NCT01176058|Secondary|Percentage of Participants With Microbiological Response at Follow-Up|Microbiological Success implies Eradication: culture negative for all Candida species present at baseline (documented), or culture data N/A (presumed). Microbiological Failure implies (1) Persistence: baseline Candida species present in repeat cultures (documented), or culture data N/A (presumed); (2) Recurrence: baseline Candida species isolated following eradication (documented), or culture data N/A (presumed); or (3) Indeterminate: culture data N/A (loss to follow-up or death that was not due to candidiasis or candidemia).|Post treatment follow-up visit (Up to Day 52)|MITT population. N=number of participants with evaluable data; participants with missing or indeterminate data are set to Failure.||percentage of participants||95% Confidence Interval|Number
823810|NCT01176058|Secondary|Percentage of Participants With Microbiological Response at EOT|Microbiological Success implies Eradication: culture negative for all Candida species present at baseline (documented), or culture data N/A (presumed). Microbiological Failure implies (1) Persistence: baseline Candida species present in repeat cultures (documented), or culture data N/A (presumed); (2) Recurrence: baseline Candida species isolated following eradication (documented), or culture data N/A (presumed); or (3) Indeterminate: culture data N/A (loss to follow-up or death that was not due to candidiasis or candidemia).|End of Treatment (Up to Day 42)|MITT population. N=number of participants with evaluable data; participants with missing or indeterminate data are set to Failure.||percentage of participants||95% Confidence Interval|Number
823811|NCT01176058|Secondary|Percentage of Participants With Microbiological Response at EOIT|Microbiological Success implies Eradication: culture negative for all Candida species present at baseline (documented), or culture data N/A (presumed). Microbiological Failure implies (1) Persistence: baseline Candida species present in repeat cultures (documented), or culture data N/A (presumed); (2) Recurrence: baseline Candida species isolated following eradication (documented), or culture data N/A (presumed); or (3) Indeterminate: culture data N/A (loss to follow-up or death that was not due to candidiasis or candidemia).|End of Intravenous Treatment (Up to Day 42)|MITT population. N=number of participants with evaluable data; participants with missing or indeterminate data are set Failure.||percentage of participants||95% Confidence Interval|Number
823812|NCT01176058|Secondary|Percentage of Participants With Clinical Response at Follow-Up|Clinical response included success and failure. Success included Cure (resolution of signs and symptoms of the Candida infection) and Improvement (significant, but incomplete resolution of signs and symptoms of Candida infection). Failure defined as No significant improvement in signs and symptoms or death due to Candida infection or circumstances prevented an evaluation from being made.|Post treatment follow-up visit (Up to Day 52)|MITT population. N=number of participants with evaluable data; participants with missing data set to Failure.||percentage of participants||95% Confidence Interval|Number
823813|NCT01176058|Secondary|Percentage of Participants With Clinical Response at EOT|Clinical response included success and failure. Success included Cure (resolution of signs and symptoms of the Candida infection) and Improvement (significant, but incomplete resolution of signs and symptoms of Candida infection). Failure defined as No significant improvement in signs and symptoms or death due to Candida infection or circumstances prevented an evaluation from being made.|End of Treatment (Up to Day 42)|MITT population. N=number of participants with evaluable data; participants with missing data set to Failure.||percentage of participants||95% Confidence Interval|Number
823814|NCT01176058|Secondary|Percentage of Participants With Clinical Response at EOIT|Clinical response included success and failure. Success included Cure (resolution of signs and symptoms of the Candida infection) and Improvement (significant, but incomplete resolution of signs and symptoms of Candida infection). Failure defined as No significant improvement in signs and symptoms or death due to Candida infection or circumstances prevented an evaluation from being made.|End of Intravenous Treatment (Up to Day 42)|MITT population. N=number of participants with evaluable data; participants with missing data set to Failure.||percentage of participants||95% Confidence Interval|Number
823815|NCT01176058|Secondary|Percentage of Participants With Global Response at End of Treatment (EOT)|"Global response included clinical and microbiological success or failure. Success - clinical success (defined as the resolution or significant improvement in signs and symptoms of invasive candidiasis) and microbiological success (defined as the eradication of Candida species present at baseline, as determined on follow-up culture, or the presumed eradication, if culture data were N/A for a participant with a successful clinical response).
Failure – Any case that did not meet the criteria for success."|End of Treatment (Up to Day 42)|MITT population. N=number of participants with evaluable data; participants with missing or indeterminate data set to Failure.||percentage of participants||95% Confidence Interval|Number
823816|NCT01176058|Primary|Percentage of Participants With Global Response at End of Intravenous Treatment (EOIT)|"Global response included clinical and microbiological success or failure. Success - clinical success (defined as the resolution or significant improvement in signs and symptoms of invasive candidiasis) and microbiological success (defined as the eradication of Candida species present at baseline, as determined on follow-up culture, or the presumed eradication, if culture data were not available [N/A] for a participant with a successful clinical response).
Failure – Any case that did not meet the criteria for success."|End of Intravenous Treatment (Up to Day 42)|Modified Intent-to-Treat (MITT) population: participants had confirmed diagnosis of candidemia or other forms of invasive candidiasis, received at least 1 dose of study medication treatment, had at least 1 post-baseline efficacy evaluation. N=number of participants with evaluable data; participants with missing or indeterminate data set to Failure.||percentage of participants||95% Confidence Interval|Number
823817|NCT01176240|Post-Hoc|Study 306A: Change in Dizziness/Lightheadedness/Feeling Faint/Feeling Like You Might Black Out (OHSA Item 1) From Baseline to Week 1|OHSA item 1 scale range: 0 (none) -10 (worst), likert scale. Change: score at Week 1 minus score at baseline. A negative score indicates improvement in symptoms during the double-blind randomized phase relative to value at baseline.|Baseline, Week 1|Last observation carried forward was used to impute missing values.||units on a scale||Standard Deviation|Mean
823818|NCT01176240|Secondary|306B Efficacy: Change in Orthostatic Hypotension Questionnaire Score (OHQ)|"The relative mean change in Orthostatic Hypotension Questionnaire (OHQ) composite score from baseline to end of study. The OHQ is the average of two sub-scales, the Orthostatic Hypotension Symptom Assessment Scale (OHSA) and the Orthostatic Hypotension Daily Activities Scale (OHDAS). Each asks the patient to rate their symptoms or disease impact over the past week. The OHSA sub-scale is the average of six items: 1) Dizziness, lightheadedness, feeling faint or feeling like you might black out; 2) Problems with vision; 3) Weakness; 4) Fatigue; 5) Trouble concentrating; and 6) Head/neck discomfort. The OHDAS sub-scale is the average of four items: 1) Standing for a short time; 2) Standing for a long time; 3) Walking for a short time; and 4) Walking for a long time. Each item is scored on a Likert scale from 0 to 10, with 10 being the most severe.
For the change from baseline, negative numbers represent improvement from baseline in OHQ score."|Baseline, Week 8|The primary analysis was defined as those patients who completed 8 week of dosing and completed the visit 7 (8 week) efficacy evaluation. Patients who did not have week 8 efficacy data were excluded from the analysis. Of note, 2 patients completed the 8 week double blind study, but did not complete the efficacy evaluations at the final visit.||units on a scale||Standard Deviation|Mean
823819|NCT01176240|Secondary|306B Efficacy: Rate of Patient Reported Falls|The average number of patient reported falls per week.|up to 10 weeks|The primary analysis was defined as those patients who completed 1 week of dosing at the identified optimal dose of study medication and completed the visit 4 (1 week) efficacy evaluation. Patients who did not have week 1 efficacy data were excluded from the analysis.||falls per week||Standard Deviation|Mean
823898|NCT01177293|Primary|Maximum Observed Plasma Concentration (Cmax)||0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 and 168 hours post dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng/mL||Full Range|Geometric Mean
823821|NCT01176240|Secondary|306B Efficacy: Change in Systolic Blood Pressure (SBP) Measurements Post Standing From Baseline to Week 1|Measure: Lowest standing systolic blood pressure reading of immediately post standing and 3 minutes post standing. Change: standing systolic blood pressure at Week 1 (Visit 4) minus standing systolic blood pressure at baseline. A positive score indicates an improvement in standing systolic blood pressure during the double-blind randomized phase relative to value at baseline.|Baseline, Week 1|One droxidopa patient did not complete the standing blood pressure measurements of the orthostatic standing test at visit 4 (one week of stable dosing)||mmHg||Standard Deviation|Mean
823822|NCT01176240|Secondary|306B Efficacy: Change in OHSA Item 1 From Baseline to Week 4 (Visit 6)|OHSA item 1 scale range: 0 (none) -10 (worst), likert scale. Change: score at Week 4 minus score at baseline. A negative score indicates an improvement in symptoms during the double-blind randomized phase relative to value at baseline.|Baseline, Week4|||units on a scale||Standard Deviation|Mean
823823|NCT01176240|Secondary|306B Efficacy: Change in OHSA Item 1 From Baseline to Week 2 (Visit 5)|OHSA item 1 scale range: 0 (none) -10 (worst), likert scale. Change: score at Week 2 minus score at baseline. A negative score indicates an improvement in symptoms during the double-blind randomized phase relative to value at baseline.|Baseline, Week2|||units on a scale||Standard Deviation|Mean
823824|NCT01176240|Post-Hoc|306A Efficacy: Patient Reported Falls|The total number of patient reported falls during the 8 week treatment period|Baseline, Week 8|||total falls per group|||Number
823825|NCT01176240|Primary|306B Efficacy: Change in Dizziness/Lightheadedness/Feeling Faint/Feeling Like You Might Black Out (OHSA Item 1)|OHSA item 1 scale range: 0 (none) -10 (worst), likert scale. Change: score at Week 1 minus score at baseline. A negative score indicates an improvement in symptoms during the double-blind randomized phase relative to value at baseline.|Baseline, Week1|The primary analysis was defined as those patients who completed 1 week of dosing at the identified optimal dose of study medication and completed the visit 4 (1 week) efficacy evaluation. Patients who did not have week 1 efficacy data were excluded from the analysis.||units on a scale||Standard Deviation|Mean
823826|NCT01176240|Primary|306A Efficacy: Change in Orthostatic Hypotension Questionnaire Score (OHQ)|"The primary efficacy endpoint for 306A is the relative mean change in Orthostatic Hypotension Questionnaire (OHQ) composite score from baseline to end of study. The OHQ is the average of two sub-scales, the Orthostatic Hypotension Symptom Assessment Scale (OHSA) and the Orthostatic Hypotension Daily Activities Scale (OHDAS). Each asks the patient to rate their symptoms or disease impact over the past week. The OHSA sub-scale is the average of six items: 1) Dizziness, lightheadedness, feeling faint or feeling like you might black out; 2) Problems with vision; 3) Weakness; 4) Fatigue; 5) Trouble concentrating; and 6) Head/neck discomfort. The OHDAS sub-scale is the average of four items: 1) Standing for a short time; 2) Standing for a long time; 3) Walking for a short time; and 4) Walking for a long time. Each item is scored on a Likert scale from 0 to 10, with 10 being the most severe.
For the change from baseline, negative numbers represent improvement from baseline in OHQ score."|Baseline, Week 8|LOCF was used to impute values for patients who did not have an end of study visit.||units on a scale||Standard Deviation|Mean
823827|NCT01176292|Primary|Clinical Flexion|Maximum, passive flexion and extension of the operated knee joint in the supine position will be measured and recorded using a long goniometer.|1 year|||degrees||Standard Deviation|Mean
823828|NCT01176292|Primary|Clinical Flexion|Maximum, passive flexion and extension of the operated knee joint in the supine position will be measured and recorded using a long goniometer.|4-6 months|||degrees||Standard Deviation|Mean
823829|NCT01176292|Secondary|Oxford Knee Score|A patient reported questionnaire for assessing the outcome of knee surgery. The minimum score is 0 and the maximum score is 48. A higher score represents a better outcome.|1 year|||score||Standard Deviation|Mean
823830|NCT01176292|Secondary|Knee Society Score|A standard clinical evaluation system for reporting results for patients undergoing total knee replacement. The minimum score is 0 and the highest score is 100. A higher score represents a better outcome.|1 year|||score||Standard Deviation|Mean
823831|NCT01176292|Secondary|Radiographic Flexion|Lateral radiographs of the knee will be taken with the patient supine with maximal passive knee flexion. Flexion will then be measured directly from these radiographs.|1 year|||degrees||Standard Deviation|Mean
823832|NCT01176292|Secondary|Radiographic Flexion|Lateral radiographs of the knee will be taken with the patient supine with maximal passive knee flexion. Flexion will then be measured directly from these radiographs.|preoperative, 4-6 weeks|||degrees||Standard Deviation|Mean
823833|NCT01176292|Primary|Clinical Flexion|Maximum, passive flexion and extension of the operated knee joint in the supine position will be measured and recorded using a long goniometer.|Preoperative, 4-6 weeks|||degrees||Standard Deviation|Mean
823834|NCT01176448|Secondary|Visual Analog Scale for Assessing Scar Improvement.|"Visual Analog Scale for assessing scar improvement. 0 : Worsening or no improvement
: 1-25% improvement
: 26-50% improvement
: 51-75% improvement
: 76-100% improvement"|3 months|"With 12 pairs of scars gave a 95% probability to detect a treatment difference at a two sided 0.05 significance level if a significant difference between treatments is 1.5 units (based on a 0
–4 scale as mentioned above). This is based on the assumption that the within-patient standard deviation of the response variable is 0.5 units."||units on a scale|Participants|Standard Deviation|Mean
823835|NCT01176448|Primary|Safey Data Score Based on Ordinal Ratings of Erythema, Edema, Bleeding, Eschar After Resurfacing|Erythema, edema, bleeding, and eschar after resurfacing were used as indicators of safety. Each was judged based on a 4 point ordinal scale 0=absent, 1=mild, 2=moderate, 3=severe.|Day 0, Week1, Month 1|Each scar was divided in half and the halves randomized to either Fractionated Laser treatment or Dermabrasion.||units on a scale|Participants|Standard Error|Mean
823836|NCT01176513|Secondary|To Compare the Ability of PET/CT Imaging With GE-148 (18F) Injection to Predict Prostate Malignancy and Distinguish it From Other Pathologies (Inflammation, Hyperplasia, Atrophy, Hemorrhage) With That of T2W MRI, DCE MRI, MR DWI, and MRSI Performed at 3T.|Use of descriptive statistics to compare the ability of the PET/CT imaging and MRI to predict malignancy, based on histopathology as the standard of truth, on a subject basis and per lesion basis.|After GE-148 (18F) Injection administration|Efficacy analyses were not performed because GE Healthcare terminated the study early for administrative reasons.|||||
824768|NCT01178268|Other Pre-specified|The Composite of ST, All Death, and All MI Rate in Single Lesion Treated Subgroup|The composite of ST, all death, and all MI rate in Patients with single lesion treated during the index procedure|24 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
823837|NCT01176513|Primary|To Assess the Magnitude of Uptake and Retention of GE-148 (18F) Injection in Malignant Prostate Tumors, Non-malignant Prostate Pathology, and Regions of Normal Prostate Tissue in Subjects With Prostate Cancer, Using PET/CT Imaging.|Quantitative measurements of the level of uptake of GE-148 (18F) Injection into each tissue type (malignant prostate tumors, non-malignant prostate pathology, and regions of normal prostate) calculated as Standardized Uptake Values (SUVs), using histopathology as the standard of truth.|After GE-148 (18F) Injection administration.|Efficacy analyses were not performed because GE Healthcare terminated the study early for administrative reasons.|||||
823838|NCT01176565|Other Pre-specified|Any Serious Adverse Event Within the 90-day Study Period|The complete count of all subjects who experienced any serious adverse events throughout their participation in the trial was included in this tabulation. Adverse events (AEs) and serious adverse events (SAEs) were assessed by the site investigators for all patients. Potential relatedness to the study treatment was a required reporting element for all adverse events but was not considered in this count. Terminology from the Medical Dictionary for Regulatory Activities (MedDRA) and severity criteria from the Common Terminology Criteria for Adverse Events (CTCAE v. 4.03) were used as a basis for reporting adverse events. Serious adverse events are defined as being fatal, life-threatening, resulting in hospitalization or prolonged hospitalization, resulting in disability or congenital anomaly, or requiring intervention to prevent permanent impairment or damage and were required to be reported promptly. An Independent Oversight Committee (IOC) reviewed and adjudicated adverse event data.|From randomization through the 90 day visit (90 ± 14 days per protocol window; up to ± 30 days data is used) or until known death, withdrawal, or loss to follow-up.|Patients may have experienced more than one adverse event. This measure is designed to show the total count of any patients who experienced any type of serious adverse event, whether it was felt to be related to the study treatment or not, throughout the duration of their participation in the study.||Participants|||Count of Participants
823839|NCT01176565|Other Pre-specified|Treatment-related Serious Adverse Event Within 72 Hours of Randomization|Adverse events (AEs) and serious adverse events (SAEs) were assessed by the site investigators for all patients, including for their potential relatedness to the study treatment. An Independent Oversight Committee (IOC) reviewed and adjudicated all adverse event data. The 72-hours-from-randomization time window was considered the most likely time frame during which treatment-related adverse events or serious adverse events would be observed. Terminology from the Medical Dictionary for Regulatory Activities (MedDRA) and severity criteria from the Common Terminology Criteria for Adverse Events (CTCAE v. 4.03) were used as a basis for reporting adverse events. Serious adverse events are defined as being fatal, life-threatening, resulting in hospitalization or prolonged hospitalization, resulting in disability or congenital anomaly, or requiring intervention to prevent permanent impairment or damage and were required to be reported promptly.|From randomization through 72 hours (3 days)|Relatedness is defined by the terms unrelated, unlikely, possibly, probably, or definitely related to the study treatment. Results are entered as the count of participants experiencing any serious adverse event within 72 hours of randomization that was determined by the site investigator to possibly or more have relationship to the study treatment.||Participants|||Count of Participants
823840|NCT01176565|Other Pre-specified|Hypotension Within 72 Hours|Hypotension (abnormally low blood pressure) was the most likely adverse event that could be associated with the study treatment, and is the primary basis (risk) on which neurological deterioration or other untoward effects of the study treatment could occur. It is therefore examined as a numerically-measured occurrence in addition to monitoring patients closely for neurological deterioration or other symptoms. Hypotension, when named as an adverse event, was defined as the syndrome of low blood pressure with SBP < 85 mmHg. Instances of hypotension were to be avoided through close monitoring, and administration of fluid bolus for SBP < 110 mmHg. If hypotension did occur, it was to be reversed as quickly as possible through discontinuation of intravenous nicardipine and intravenous fluid administration, which can be accomplished readily in a variety of settings where patients with intracerebral hemorrhage are routinely housed during early hospitalization.|From randomization through 72 hours from randomization|Blood pressure including the potential for hypotension was monitored according to intensive care unit standards for ICH patients during early hospitalization. Blood pressure was monitored more closely during the 24-hour study period and at times when nicardipine (or other/secondary IV antihypertensive medications) were being titrated.||Participants|||Count of Participants
823841|NCT01176565|Other Pre-specified|Neurological Deterioration Within 24 Hours, Defined by a Decrease of 2 or More Points on the GCS Score or an Increase of 4 or More Points on the NIHSS Score From Baseline, Not Related to Sedation or Hypnotic-agent Use and Sustained for at Least 8 Hours.|Neurologic deterioration was measured using two scales. The Glasgow Coma Scale (GCS) score measures of level of consciousness in eye, motor, and verbal components. At least one point is given in each category. The scale ranges from 3 to 15, with 3 indicating deep unconsciousness and 15 indicating consciousness is not impaired. The National Institutes of Health Stroke Scale (NIHSS) quantifies neurologic deficits in 11 categories. Level of consciousness, horizontal eye movement, visual fields, facial palsy, movement in each limb, sensation, language & speech, and extinction or inattention on one side of the body are tested. Scores range from 0 to 42, with 0 indicating normal function and higher scores indicating greater deficit severity. Neurological status was checked per ICU standards through 24 hours, recommended as hourly GCS and full assessment every 2 hours. NIHSS assessment at baseline and 24 +/- 3 hours was pre-specified. Assessments were added for suspected neurological change.|From randomization through the 24-hour treatment period|All subjects were assessed for neurological status regularly. Grid-estimated verbal scoring based on eye and motor scores was used for intubated patients so that GCS scores could be compared over time and was consistent across patients.||Participants|||Count of Participants
823863|NCT01176968|Secondary|Electrocardiogram Q Wave to the End of the S Wave Corresponding to Ventricle Depolarization (QRS) Duration at 6 Months Post-randomization.|Electrocardiogram Q wave to the end of the S wave corresponding to ventricle depolarization (QRS) duration at 6 months post-randomization. The continuous endpoints were assessed using analysis of covariance (ANCOVA) model, fitted with corresponding baseline and treatment. These were analyzed at 6 months based on last observation carried forward (LOCF) and also using all available data up to end of study.|6 months|The FAS using the ITT principle, regardless of compliance with the study drug and the protocol was used.||Milliseconds (msec)||Standard Deviation|Mean
830648|NCT01231841|Secondary|Reduction of VB Repertoire Associated With r-ATG/CsA Combination|We will perform molecular analysis of the TCR repertoire to identify “marker” immunodominant clone specimens using VB typing.|Every 4 weeks||||||
823842|NCT01176565|Secondary|Hematoma Expansion (Number of Patients With Hematoma Expansion of 33% or Greater Between the Baseline and 24 +/- 6 Hours Head CTs, as Measured by the Central Reader for Patients With Readable Scans for Both Time Points Submitted by Data Lock.)|Hematoma expansion as determined by serial CT scans: Hematoma expansion was defined as an increase in the volume of intraparenchymal hemorrhage of 33% or greater as measured by a central imaging analyst who was was unaware of the treatment assignments, clinical findings, and time points of image acquisition. The area of the hematoma was delineated by image analysis software with the use of density thresholds on each slice, followed by manual correction. To ensure accuracy and consistency of the readings, images were coded randomly and independently of subject numbers and manual correction was also done without awareness of treatment assignments, clinical findings, or time points of image acquisition. This data point is defined as being present (hematoma expansion of 33% or more was calculated between the baseline scan hematoma volume and the 24 +/- 6 hours hematoma volume measures at data analysis), meaning that hematoma expansion as defined must have occurred or it was not counted.|From the baseline head CT to the 24 +/- 6 hours from randomization head CT|Participants with readable head CTs at baseline and 24 +/- 6 hours from randomization (submitted before data lock) were analyzed. Hematoma expansion was only recorded as present if ≥ 33% volume increase was calculated. Scans done outside of time window + margin, submitted after data lock, or not readable in standard DICOM format could not be used.||Participants|||Count of Participants
823843|NCT01176565|Secondary|Quality of Life at 90 Days Using EuroQol (EQ) Measures: EQ-5D (EuroQol Five Dimension), Consisting of Standardized EQ-5D-3L (EuroQol Five Dimension, Three-Level) Questionnaire and EQ VAS (EuroQol Visual Analog Scale) Scores|Standardized scales developed by the EuroQol Research Foundation were used as a secondary outcome measure in addition to the mRS scale score. The EQ-5D is a simple, standardized non-disease-specific instrument for describing and valuating health-related quality of life. The EQ-5D-3L questionnaire consists of 5 questions in 5 different domains and allows for responses from 1 (the best outcome) to 3 (the worst outcome) in each of five categories (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Total scores range from 5 to 15, with lower scores indicating better quality of life and a higher score indicating a worse quality of life. A second component of EuroQol outcome measurements is a printed 20 cm visual analogue scale (EQ VAS) that appears somewhat like a thermometer, on which a score from 0 (worst imaginable health state or death) to 100 (best imaginable health state) is marked by the patient (or, when necessary, their proxy) with the scale in view.|90 days (± 14 days per protocol window; up to ± 30 days data is used) from randomization|All available valid data were analyzed. Outcomes collected outside of 90 ± 30 days weren't considered valid. EQ-5D data were missing for 28 patients in the intensive group & for 27 in the standard group. EQ VAS data were missing for 144 patients in the intensive group and for 146 in the standard group.||units on a scale||Full Range|Median
823844|NCT01176565|Primary|Death or Disability According to Modified Rankin Scale Score at 90 Days (3 Months) From Randomization|The primary outcome was death or disability, defined by modified Rankin scale (mRS) of 4-6 at 90 days following treatment. The modified Rankin Scale score ranges from 0, indicating no symptoms, to 6, indicating death. A score of 4 indicates moderately severe disability including the inability to walk or attend to one's own bodily needs. A score of 5 indicates severe disability; bedridden, incontinent, and requiring constant nursing care. To score a 3 or lower on the mRS, a person must at least be able to walk without the assistance of another person. We chose the mRS because of its high inter-observer reliability, superiority to other indices, and consistency with previous trials in patients with ICH. Reliability was further increased by use of a structured interview template and by requiring mRS assessors to pass a certification test. Persons conducting the 90-day mRS assessment were to be unaware of the treatment arm or clinical course of the patients they assessed.|90 days (± 14 days per protocol window; up to ± 30 days data is used) from randomization|All subjects were analyzed for known death at any time following randomization. Patients surviving through 90 days (± 14 days per protocol window; data used up to ± 30 days) were assessed for disability using the mRS. Patients not completing the 90-day visit within 30 days of due date aren't included in the death & disability participant counts.||Participants|||Count of Participants
823845|NCT01176773|Secondary|Adverse Events||12 months|Intent-to-treat||percentage of subjects|||Number
823846|NCT01176773|Secondary|Number of Subjects Who Attain Their Lip Treatment Goal|"Prior to treatment and in consultation with the Investigator, the subject establishes a realistic lip fullness treatment goal. At follow-up, attainment is assessed as yes or no. The outcome measure is the percentage of subjects responding yes as to whether their pre-established lip fullness treatment goal had been attained."|1-12 months|All subjects who provided a lip fullness goal achievement assessment||percentage of subjects|||Number
823847|NCT01176773|Secondary|Subject Assessment of Appearance and Feel of the Lips Using the Look and Feel Scale|The scale consists of subcategories pertaining to how the subjects perceived aspects of their lips (e.g., softness, smoothness, etc). The outcome measure is the percentage of subjects who scored 0-3 on an 11-point scale, where a lower score on the scale indicates a positive result.|3 months|All subjects with a Look and Feel assessment||percentage of subjects|||Number
823848|NCT01176773|Secondary|Investigator Assessment of Oral Commissures Using the Oral Commissures Severity Scale|Score on 4-point Oral Commissures Severity Scale, where 0 is none and 3 is severe. A decreased score indicates improvement.|12 months|All subjects who were treated in their oral commissures||units on a scale||Standard Deviation|Mean
823849|NCT01176773|Secondary|Investigator Assessment of Perioral Line Severity Using the Perioral Line Severity Scale|Score on 4-point Perioral Line Severity Scale, where 0 is none and 3 is severe. A decreased score indicates improvement.|12 months|All subjects who were treated for perioral lines||units on a scale||Standard Deviation|Mean
823850|NCT01176773|Primary|Investigator Assessment of the Subject's Overall Lip Fullness on the 4-point Lip Fullness Scale|The responder rate at 3 months, where a responder was defined as an improvement (increase) on the Lip Fullness Scale of ≥ 1 grade compared with the baseline assessment|3 months|Intent-to-treat||percentage of responders||95% Confidence Interval|Number
823899|NCT01177293|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration-time curve from time zero (pre-dose) to the time of the last measurable concentration (AUClast).|0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 and 168 hours post dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||hr*ng/mL||Full Range|Geometric Mean
823851|NCT01176877|Secondary|To Assess the Impact of an Educational Lecture on Long-term Knowledge Retention About Keloid Scars by Comparing Mean Scores Between Knowledge Assessment Questionnaires Administered Before an Educational Lecture and 3 Months After an Educational Lecture|All subjects completed a written questionnaire to assess knowledge about keloid scars before an educational lecture about keloids, immediately after the educational lecture about keloids, and 3 months after the educational lecture about keloids. This written questionnaire to assess knowledge about keloid scars contained 19 questions related to risk factors for developing keloid scars, keloid scar prevention, and keloid scar treatment. A correct response to a question was awarded 1 point and all correct responses were summed to achieve a total score. Possible total score ranged from 0 to 19. A score of 0 is associated with worse knowledge about keloid scars and a score of 19 is associated with better knowledge about keloid scars.|before and 3 months after a 5 minute educational lecture|Patients enrolled who were available for phone contact 3 months following intervention.||score on a scale||Full Range|Mean
823852|NCT01176877|Primary|To Assess the Impact of an Educational Lecture on Knowledge About Keloid Scars by Comparing Mean Scores Between Knowledge Assessment Questionnaires Administered Before an Educational Lecture and Immediately After an Educational Lecture|All subjects completed a written questionnaire to assess knowledge about keloid scars before an educational lecture about keloids, immediately after the educational lecture about keloids, and 3 months after the educational lecture about keloids. This written questionnaire to assess knowledge about keloid scars contained 19 questions related to risk factors for developing keloid scars, keloid scar prevention, and keloid scar treatment. A correct response to a question was awarded 1 point and all correct responses were summed to achieve a total score. Possible total score ranged from 0 to 19. A score of 0 is associated with worse knowledge about keloid scars and a score of 19 is associated with better knowledge about keloid scars.|immediately before and after a 5 minute educational lecture|||score on a scale||Full Range|Mean
823853|NCT01176955|Primary|Adherence to Study Medication|Adherence will be objectively measured with the Medication Event Monitoring System (MEMS) cap and the percentage of prescribed doses taken will be reported.|12 weeks|||Percent of prescribed doses taken||Full Range|Median
823854|NCT01176955|Secondary|The Measured Adherence by the MEMS Cap in Relation to the Change (Dynamic Assessment) in the Acne Global Assessment.|All study subjects' objective adherence will be compared to clinical improvement as measured by the Acne Global Assessment.|12 weeks||||||
823855|NCT01176955|Secondary|The Measured Adherence by the MEMS Cap in Relation to the Patient Reported Adherence Via the Internet Survey.|Study subjects' self-reported adherence (in the intervention group, via the weekly internet survey) will be compared to objectively measured adherence via MEMS caps.|12 weeks||||||
823856|NCT01176955|Secondary|The Change (Dynamic Assessment) From Baseline to End of Treatment in Lesion Counts.|Both inflammatory (papules, pustules and nodules) and non-inflammatory (open and closed comedones) acne lesions will be counted by a study investigator. Percentage change from baseline to the final study visit will be calculated.|Baseline to 12 weeks|||percent change in lesion count||Standard Deviation|Mean
823857|NCT01176955|Secondary|The Change (Dynamic Assessment) in the Acne Global Assessment From Baseline to End of Study.|Acne Global Assessment is measured by a study investigator and is an overall assessment of the subject's acne severity, on a 0 (clear) to 5 (very severe) scale.|Baseline to 12 weeks|||units on a scale||Standard Deviation|Mean
823858|NCT01176968|Secondary|Change in Serum Level of Biomarker (Interleukin-6) at 6 Months Post-randomization.|Change in serum level of Interleukin-6 at 6 months post-randomization. The continuous endpoint was assessed using ANCOVA model, fitted with corresponding baseline and treatment. It was analyzed at 6 months based on LOCF and also using all available data up to end of study.|6 months|The Biomarker Analysis Set is a subset of FAS subjects who have the biomarker data (ICTP, PINP, PIIINP, Interleukin-6, aldosterone, cortisol, and Galactin 3) available.||pg/mL||Inter-Quartile Range|Median
823859|NCT01176968|Secondary|Change in Serum Level of Biomarker (ICTP) at 6 Months Post-randomization.|Change in serum level of ICTP at 6 months post-randomization. The continuous endpoint was assessed using ANCOVA model, fitted with corresponding baseline and treatment. It was analyzed at 6 months based on LOCF and also using all available data up to end of study.|6 months|The Biomarker Analysis Set is a subset of FAS subjects who have the biomarker data (ICTP, PINP, PIIINP, Interleukin-6, aldosterone, cortisol, and Galactin 3) available.||μg/L||Inter-Quartile Range|Median
823860|NCT01176968|Secondary|Change in Serum Levels of Biomarkers (PIIINP, Galectin 3, and PINP) at 6 Months Post-randomization.|Change in serum levels of PIIINP, Galectin 3, and PINP at 6 months post-randomization. The continuous endpoints were assessed using ANCOVA model, fitted with corresponding baseline and treatment. These were analyzed at 6 months based on LOCF and also using all available data up to end of study.|6 months|The Biomarker Analysis Set is a subset of FAS subjects who have the biomarker data (ICTP, PINP, PIIINP, Interleukin-6, aldosterone, cortisol, and Galactin 3) available.||ng/mL||Inter-Quartile Range|Median
823861|NCT01176968|Secondary|Change in Serum Levels of Biomarkers (Aldosterone and Cortisol) at 6 Months Post-randomization.|Change in serum levels of aldosterone and cortisol at 6 months post-randomization. The continuous endpoints were assessed using ANCOVA model, fitted with corresponding baseline and treatment. These were analyzed at 6 months based on LOCF and also using all available data up to end of study.|6 months|The Biomarker Analysis Set is a subset of FAS subjects who have the biomarker data (carboxyterminal telopeptide of type I collagen [ICTP], procollagen type I N-terminal peptide [PINP], procollagen type III N-terminal peptide [PIIINP], Interleukin-6, aldosterone, cortisol, and Galactin 3) available.||nmol/L||Inter-Quartile Range|Median
823862|NCT01176968|Secondary|Left Atrial Diameter (LAD) (Recorded on Each Occasion an Echocardiogram is Conducted).|LAD recorded each time an echocardiogram is conducted. The continuous endpoints were assessed using ANCOVA model, fitted with corresponding baseline and treatment. These were analyzed at 6 months based on LOCF and also using all available data up to end of study.|0-24 months|The FAS using the ITT principle, regardless of compliance with the study drug and the protocol was used.||Centimeters (cm)||Standard Deviation|Mean
823873|NCT01177007|Secondary|Safety as Graded by CTCAE Version 3.0|Clinical and biochemical toxicity that were assessed as at least possibly related to treatment were recorded from the day of treatment until protocol exit or death. Toxicities were graded by the Common Terminology Criteria for Adverse Events (CTCAE) v3.0.|12 months|50 participants were assessed for adverse events, with a total of 207 adverse events reported. Two patients had grade 5 toxicities (grade 5 cholecystitis and death), which were attributed to disease progression and were not device-related.||adverse events|Adverse Events||Number
823864|NCT01176968|Secondary|Second or Subsequent Non-fatal Myocardial Infarction (MI).|The occurrence of second or subsequent nonfatal MI. Time-to-event analyses were measured from the date of randomization. A subject who did not experience the endpoint(s) of interest was censored on the last day the subject was confirmed by the investigator to be endpoint-free. The time-to-event distributions were summarized by treatment group using Kaplan-Meier estimates of cumulative incidence.|0-24 months|The FAS using the ITT principle, regardless of compliance with the study drug and the protocol was used. The efficacy analysis data sets for clinical events included all available study endpoints. Furthermore, only events confirmed by the EAC were used.||Events|||Number
823865|NCT01176968|Secondary|Decision to Provide an Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT).|The decision to provide an ICD or CRT. Time-to-event analyses were measured from the date of randomization. A subject who did not experience the endpoint(s) of interest was censored on the last day the subject was confirmed by the investigator to be endpoint-free. The time-to-event distributions were summarized by treatment group using Kaplan-Meier estimates of cumulative incidence.|0-24 months|The FAS using the ITT principle, regardless of compliance with the study drug and the protocol was used.||Events|||Number
823866|NCT01176968|Secondary|Brain (B-type) Natriuretic Peptide (BNP) >200 pg/mL or NT-proBNP >450, >900 or >1800 pg/mL for Ages <50 Years, 50-75 Years and >75 Years, Respectively (Recorded 1 Month or Later Post-randomization).|The occurrence of first occurrence of BNP >200 pg/mL or NT-proBNP >450, >900 or >1800 pg/mL for ages <50 years, 50 to 75 years and >75 years, respectively (recorded 28 days or later post-randomization). Time-to-event analyses were measured from the date of randomization. A subject who did not experience the endpoint(s) of interest was censored on the last day the subject was confirmed by the investigator to be endpoint-free. The time-to-event distributions were summarized by treatment group using Kaplan-Meier estimates of cumulative incidence.|0-24 months|The FAS using the ITT principle, regardless of compliance with the study drug and the protocol was used.||Events|||Number
823867|NCT01176968|Secondary|First Recorded Ejection Fraction (EF) of ≤40% (Recorded 1 Month or Later Post-randomization).|The occurrence of first recorded EF ≤40% (recorded 28 days or later post-randomization). Time-to-event analyses were measured from the date of randomization. A subject who did not experience the endpoint(s) of interest was censored on the last day the subject was confirmed by the investigator to be endpoint-free. The time-to-event distributions were summarized by treatment group using Kaplan-Meier estimates of cumulative incidence.|0-24 months|The FAS using the ITT principle, regardless of compliance with the study drug and the protocol was used. The efficacy analysis data sets for clinical events included all available study endpoints.||Events|||Number
823868|NCT01176968|Secondary|First and Each Subsequent Episode (After an Event Free Interval of ≥ 48 Hours) of Sustained Ventricular Tachycardia or Ventricular Fibrillation.|The occurrence of first and each subsequent episode (after an event-free interval of ≥ 48 hours) of sustained ventricular tachycardia or ventricular fibrillation. Time-to-event analyses were measured from the date of randomization. A subject who did not experience the endpoint(s) of interest was censored on the last day the subject was confirmed by the investigator to be endpoint-free. The time-to-event distributions were summarized by treatment group using Kaplan-Meier estimates of cumulative incidence.|0-24 months|The FAS using the ITT principle, regardless of compliance with the study drug and the protocol was used. The efficacy analysis data sets for clinical events included all available study endpoints. Furthermore, only events confirmed by the EAC were used.||Events|||Number
823869|NCT01176968|Secondary|Diagnosis of Heart Failure|The occurrence of first diagnosis of heart failure from the date of randomization. Time-to-event analyses were measured from the date of randomization, and a subject who did not experience the endpoint(s) of interest was censored on the last day the subject was confirmed by the investigator to be endpoint-free. The time-to-event distributions were summarized by treatment group using Kaplan-Meier estimates of cumulative incidence.|0-24 months|The FAS using the ITT principle, regardless of compliance with the study drug and the protocol was used. The efficacy analysis data sets for clinical events included all available study endpoints. Furthermore, only events confirmed by the EAC were used.||Events|||Number
823870|NCT01176968|Secondary|Cardiovascular Mortality|The occurrence of cardiovascular mortality from randomization. Time-to-event analyses were measured from the date of randomization. A subject who did not experience the endpoint(s) of interest was censored on the last day the subject was confirmed by the investigator to be endpoint-free. The time-to-event distributions were summarized by treatment group using Kaplan-Meier estimates of cumulative incidence.|0-24 months|The FAS using the ITT principle, regardless of compliance with the study drug and the protocol was used. The efficacy analysis data sets for clinical events included all available study endpoints. Furthermore, only events confirmed by the EAC were used.||Events|||Number
823871|NCT01176968|Primary|First Event of Cardiovascular Mortality, Re-hospitalization or Extended Initial Hospital Stay Due to Diagnosis of Heart Failure, Sustained Ventricular Tachycardia or Fibrillation, Ejection Fraction ≤40% or BNP Above Age Adjusted Cut Off|Cardiovascular mortality is defined as any mortality adjudicated as death due to sudden cardiac death, myocardial infarction (MI), worsening heart failure, cardiac arrhythmia, other cause (such as pulmonary embolism, peripheral arterial disease [PAD], etc.). Hospitalization due to congestive heart failure (CHF) and requires extended hospital stay or frequent visits to emergency room, observation unit or in-patient care, due to CHF as the primary or secondary diagnosis supported by a discharge report or clinical summary for hospitalization as determined by the endpoint adjudication committee (EAC). A composite of time to first event of cardiovascular mortality (CV), re-hospitalization or extended initial hospital stay due to diagnosis of heart failure, sustained ventricular tachycardia or fibrillation, ejection fraction ≤40% after 1 month or BNP >200 pg/mL or NT-proBNP >450 pg/mL (age <50 years); >900 pg/mL (age 50 to 75 years) or >1800 pg/mL (age >75 years) after 1 month.|0-24 months|The Full Analysis Set (FAS) using the intent-to-treat (ITT) principle, regardless of compliance with the study drug and the protocol was used. The efficacy analysis data sets for clinical events included all available study endpoints.||Events|||Number
823872|NCT01177007|Secondary|Mean Radiation Dose Delivered to Total Liver|Therasphere dose calculation was performed using positron emission tomography-computed tomography (PET/CT) and single-photon emission computed tomography (SPECT) imaging post-procedure to estimate the actual delivered dose of Theraspheres to the liver.|24 hours|Mean radiation doses were calculated for the total cohort of participants and also stratified according to disease type - colorectal cancer, neuroendocrine, and non-CRC/non-NE.||Gray||Standard Deviation|Mean
823874|NCT01177007|Secondary|Overall Survival (OS) Rate at 2 Years|"Measured from the date corresponding to initiation of therapy until the date of death due to any cause. At the time of registration, the outcome measure was entered in clinicaltrials.gov as open-ended. At the time of results reporting, this outcome was presented as Up to 2 years. Overall survival was analyzed via Kaplan-Meier methodology with log-rank test using all 50 patients on study and stratified based on disease type. 2-year OS rates were also stratified based on tumor burden."|Up to 2 years|2-year OS rate for all patients (n=50) were analyzed and also stratified based on tumor burden: Patients with tumor burden of 25% or less (n=34) and patients with tumor burden greater than 25% (n=16).||percentage of participants|||Number
823875|NCT01177007|Secondary|Overall Survival (OS)|"Measured from the date corresponding to initiation of therapy until the date of death due to any cause. At the time of registration, the outcome measure was entered in clinicaltrials.gov as open-ended. Overall survival was analyzed via Kaplan-Meier methodology with log-rank test using all 50 patients on study and stratified based on disease type."|Median follow-up time was 11.41 months (CI: 1.5-33.7)|Median OS for all patients (n=50) were analyzed and also stratified based on disease type: CRC (n=12); NE (n=26); and non-CRC/non-NE (n=12).||months||95% Confidence Interval|Median
823876|NCT01177007|Secondary|Tumor Response by the European Association for the Study of the Liver (EASL) Criteria|"Efficacy as assessed by radiographic tumor response using EASL criteria at baseline up to 12 months post treatment.
Complete Response (CR): Achieving 100% tumor necrosis of targeted lesions Partial Response (PR): Demonstrating greater than 50% tumor necrosis in targeted lesions Progressive Disease (PD): Reappearance of or increased tumor enhancement greater than 25% in targeted lesions Stable Disease (SD): Not meeting requirements for CR or PR and not demonstrating evidence of progression in targeted lesions."|12 months|RECIST for all applicable patients (n=43) were analyzed and also stratified based on disease type: CRC (n=9); NE (n=22); and non-CRC/non-NE (n=12). 7 out of the 50 patients were not analyzed due to lack of follow-up imaging.||Participants|||Count of Participants
823877|NCT01177007|Secondary|Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) v1.0|"Efficacy as assessed by radiographic tumor response using RECIST criteria at baseline, at 4 weeks post treatment, and subsequent 3 month intervals.
Complete Response (CR): Disappearance of all lesions targeted by Y90 Partial Response (PR): At least 30% decrease in the sum of longest diameter (LD) of lesions targeted by Y90 Progressive Disease (PD): At least 20% increase in sum of LD of lesions targeted by Y90 Stable Disease (SD): Neither sufficient shrinkage for PR nor sufficient increase for PD."|12 months|RECIST for all applicable patients (n=43) were analyzed and also stratified based on disease type: CRC (n=9); NE (n=22); and non-CRC/non-NE (n=12).||Participants|||Count of Participants
823878|NCT01177007|Secondary|Time to Progression (TTP) of the Treated Lesion(s) According to EASL Criteria|This outcome was not assessed. Instead, the primary outcome of progression-free survival based on RECIST and EASL criteria was assessed and reported.|Evaluated 4 weeks following each TheraSpheres procedure, and at 2-3 month intervals thereafter.|Analysis for TTP was not performed. In lieu of TTP, the PFS based on RECIST and EASL criteria was analyzed.|||||
823879|NCT01177007|Primary|Progression-free Survival (PFS) of the Treated Lesion(s) According to RECIST and EASL Criteria|Progression-free survival was defined as the time from the date of Y-90 radioembolization to date of disease progression or latest follow-up. PFS was analyzed via Kaplan-Meier methodology with log-rank test using all 50 patients on study and stratified based on disease type. RECIST and EASL criteria were used to assess progression with kappa value for intermethod agreement of treatment responses of 0.9.|2 years|Median PFS for all subjects and stratified based on disease type.||months||95% Confidence Interval|Median
823880|NCT01177007|Primary|Time to Progression (TTP) of the Treated Lesion(s) According to RECIST Criteria|This outcome was not assessed. Instead, the primary outcome of progression-free survival based on RECIST and EASL criteria was assessed and reported.|Evaluated 4 weeks following each TheraSpheres procedure, and at 2-3 month intervals thereafter.|These data were not collected. See outcome measure #2.|||||
823881|NCT01177098|Primary|Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12|Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP is the average IOP of both eyes and was evaluated at Week 12 at Hour 0, Hour 2 and Hour 8.|Week 12|Intent-to-treat population included all randomized participants.||mm Hg||Standard Deviation|Mean
823882|NCT01177098|Primary|Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 6|Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP is the average IOP of both eyes and was evaluated at Week 6 at Hour 0, Hour 2 and Hour 8.|Week 6|Intent-to-treat population included all randomized participants.||mm Hg||Standard Deviation|Mean
823883|NCT01177098|Secondary|Change From Baseline in Average Eye IOP at Each Hour Evaluated at Week 12|Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP was evaluated at Baseline and Week 12 at Hour 0, Hour 2 and Hour 8. Average eye IOP is defined as the average of the IOP in both eyes. A negative number change from baseline indicates a reduction in IOP (improvement).|Baseline, Week 12|Intent-to-treat population included all randomized participants.||mm Hg||Standard Deviation|Mean
823884|NCT01177098|Secondary|Change From Baseline in Worse Eye IOP at Each Hour Evaluated at Week 12|Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. IOP was evaluated at Baseline and Week 12 at Hour 0, Hour 2 and Hour 8 in the worse eye, defined as the eye with the worse (higher) IOP at baseline. A negative number change from baseline indicates a reduction in IOP (improvement).|Baseline, Week 12|Intent-to-treat population included all randomized participants.||mm Hg||Standard Deviation|Mean
823885|NCT01177098|Primary|Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 2|Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP is the average IOP of both eyes and was evaluated at Week 2 at Hour 0, Hour 2 and Hour 8.|Week 2|Intent-to-treat population included all randomized participants.||mm Hg||Standard Deviation|Mean
823886|NCT01177098|Primary|Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12|Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. IOP was evaluated at Baseline and Week 12 at Hour 0, Hour 2 and Hour 8 in the worse eye, defined as the eye with the worse (higher) IOP at baseline. A negative number change from baseline indicates a reduction in IOP (improvement).|Baseline, Week 12|Per-protocol population included randomized participants who did not have a protocol violation that significantly affected the conduct or the results of the trial.||mm Hg||Standard Deviation|Mean
823887|NCT01177228|Primary|Area Under the Drug Effect Time Curve [AUEC(0-last)] as Measured by Inhibition of the MAdCAM-1-Fc Marker|AUEC (0-last) is the area under the drug effect-time curve until the last available time point. Mean percent inhibition over time [AUEC(0-last)] was determined for the MAdCAM-1-Fc marker. MAdCAM-1-Fc is a fusion of human MAdCAM-1 with parts of a mouse monoclonal antibody.|Days 1, 2, 3, 4, 8, 15, 29, 43, 57, 71, 85, 86, 87, 89, 92, 99, 113, 127, 141, 155, 169, 183, 197, 211, 225, 239, and 253|"PD Analysis Set; participants with available data (indicated by n)"||percent inhibition*days||Standard Deviation|Mean
823888|NCT01177228|Primary|Area Under the Drug Effect Time Curve [AUEC(0-last)] as Measured by Inhibition of the ACT-1 Marker|AUEC (0-last) is the area under the drug effect-time curve until the last available time point. Mean percent inhibition over time [AUEC(0-last)] was determined for the Act-1 marker. Act-1 is a mouse antibody similar to vedolizumab that also binds α4β7 integrin.|Days 1, 2, 3, 4, 8, 15, 29, 43, 57, 71, 85, 86, 87, 89, 92, 99, 113, 127, 141, 155, 169, 183, 197, 211, 225, 239, and 253|"PD Analysis Set; participants with available data (indicated by n)"||percent inhibition*days||Standard Deviation|Mean
823889|NCT01177228|Primary|Maximum Drug Effect (Emax) as Measured by Inhibition of the MAdCAM-1-Fc Marker|"The target of vedolizumab is α4β7 integrin, a receptor found on inflammatory immune cells that guides these inflammatory cells to the gut and binds to the mucosal addressin cell adhesion molecule-1 (MAdCAM-1) on gut endothelial cells. The extent of the α4β7 receptor saturation by vedolizumab was assessed using the MAdCAM-1-Fc binding interference assay. MAdCAM-1-Fc is a fusion of human MAdCAM-1 with parts of a mouse monoclonal antibody. The assay measures the percent inhibition of the MAdCAM-1-Fc binding to α4β7 integrin due to the presence of vedolizumab binding.
Emax was calculated on Day 1, Day 85, and based on all available data."|Days 1, 2, 3, 4, 8, 15, 29, 43, 57, 71, 85, 86, 87, 89, 92, 99, 113, 127, 141, 155, 169, 183, 197, 211, 225, 239, and 253|"PD Analysis Set; participants with available data (indicated by n)"||percent inhibition||Standard Deviation|Mean
823890|NCT01177228|Primary|Maximum Drug Effect (Emax) of Vedolizumab as Measured by Percent Inhibition of the Act-1 Marker|"The target of vedolizumab is α4β7 integrin, a receptor found on inflammatory immune cells that guides these inflammatory cells to the gut and binds to the Mucosal Addressin Cell Adhesion Molecule-1 (MAdCAM-1) on gut endothelial cells. The extent of the α4β7 receptor saturation by vedolizumab was assessed using the Act-1 binding interference assay. Act-1 is a mouse antibody similar to vedolizumab that also binds α4β7 integrin. The assay measures the percent inhibition of the Act-1 due to the presence of vedolizumab binding.
Emax was calculated on Day 1, Day 85 and based on all available data."|Days 1, 2, 3, 4, 8, 15, 29, 43, 57, 71, 85, 86, 87, 89, 92, 99, 113, 127, 141, 155, 169, 183, 197, 211, 225, 239, and 253|"Pharmacodynamic (PD) Analysis Set, defined as all participants for whom there were sufficient data to estimate PD. Analyses only include participants with available data (indicated by n)."||percent inhibition||Standard Deviation|Mean
823891|NCT01177228|Primary|Terminal Phase Elimination Half-life (t½) of Vedolizumab|Terminal phase elimination half-life (t½) is the time required for half of the drug to be eliminated from the plasma.|Pre-dose through Day 253|PK Analysis Set; participants with available data||days||Standard Deviation|Mean
823892|NCT01177228|Primary|Area Under the Plasma Concentration-Time Curve (AUC) for Vedolizumab|"AUC was calculated for 3 time intervals during the study:
AUC (Day 0-14): from administration on Day 0 to last quantifiable concentration on Day 14, selected to capture the AUC following the first dose of vedolizumab until administration of the second dose
AUC(Day 85-99): from administration on Day 85 to last quantifiable concentration on Day 99, selected to assess the amount of drug accumulation with the planned loading regimen by comparing it to AUC(Day 0-14)
AUC(Day 85-141): from the first quantifiable concentration on Day 85 to the last quantifiable concentration on Day 141, selected to assess the drug exposure over an 8-week period"|Days 0-14, Days 85-99, Days 85-141|PK Analysis Set; participants with available data at each time point (indicated by “n”).||day*μg/mL||Standard Deviation|Mean
823893|NCT01177228|Primary|Cmin: Minimum Observed Plasma Concentration of Vedolizumab|Minimum observed plasma concentration (Cmin) is the lowest plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Day 85, prior to and 2, 12, 24, 48, and 72 hours after dosing.|PK Analysis Set; participants with available data.||μg/mL||Standard Deviation|Mean
823894|NCT01177228|Primary|Cmax: Maximum Observed Plasma Concentration of Vedolizumab on Days 1 and 85|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Days 1 and 85, prior to and 2, 12, 24, 48, and 72 hours after dosing.|"Pharmacokinetic (PK) Analysis Set, defined as all vedolizumab participants for whom there were sufficient data to estimate PK. Analyses only include participants with available data at each time point (indicated by n)."||µg/mL||Standard Deviation|Mean
823895|NCT01177228|Primary|Number of Participants With Adverse Events|"An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with the treatment. The investigator systematically collected information adequate to determine both the outcome and severity of the AE, and whether or not it was drug-related or met the criteria for classification as a serious adverse event (SAE). An SAE was defined as an AE that resulted in (or posed risk for) death, inpatient hospitalization (or prolonging hospitalization), or congenital, persistent or significant disability/incapacity.
The intensity for each AE was defined according to the following criteria:
Mild: Awareness of sign or symptom, but easily tolerated Moderate: Discomfort enough to cause interference with normal daily activities Severe: Inability to perform normal daily activities."|From the first date of study drug administration through Day 253|Safety Analysis Set, defined as all enrolled participants who received at least 1 dose of study treatment. One participant was randomized but not dosed and is not included in this population.||participants|||Number
823896|NCT01177293|Secondary|Plasma Decay Half-life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 and 168 hours post dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||hr||Standard Deviation|Mean
823897|NCT01177293|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 and 168 hours post dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||hr||Full Range|Median
823900|NCT01177293|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 and 168 hours post dose|Pharmacokinetic (PK) parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||hr*ng/mL||Full Range|Geometric Mean
823901|NCT01177384|Primary|Number of Participants Who Discontinued Study Drug Due to an Adverse Event||Up to 24 Weeks|All participants as treated population defined as all randomized participants who received at least one dose of study drug. Data were excluded after the initiation of rescue therapy.||Participants|||Number
823902|NCT01177384|Primary|Number of Participants Who Experienced at Least One Adverse Event||Up to Week 24 + 14 Day Post-Study Follow-up|All participants as treated population defined as all randomized participants who received at least one dose of study drug. Data were excluded after the initiation of rescue therapy.||Participants|||Number
823903|NCT01177384|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Change from baseline at Week 24 is defined as Week 24 FPG minus Week 0 FPG. Efficacy analyses treated data as missing after the initiation of rescue therapy.|Baseline and Week 24|Full Analysis Set, all randomized participants except those who: failed to take at least 1 dose of study treatment, lacked all post-randomization data for the FPG subsequent to at least 1 dose of study treatment, or lacked baseline data for the FPG. Last observation carried forward (missing data approach).||mg/dL||95% Confidence Interval|Least Squares Mean
823904|NCT01177384|Primary|Change From Baseline in Hemoglobin A1c (A1C) at Week 24|A1C is measured as a percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent. Efficacy analyses treated data as missing after the initiation of rescue therapy.|Baseline and Week 24|Full Analysis Set, all randomized participants except those who: failed to take at least 1 dose of study treatment, lacked all post-randomization data for the A1C subsequent to at least 1 dose of study treatment, or lacked baseline data for the A1C. Last observation carried forward (missing data approach).||Percent||95% Confidence Interval|Least Squares Mean
823905|NCT01177410|Primary|The Number of Months That Subjects Are Monthly Responders in Both IBS-related Abdominal Pain AND Stool Consistency During the Entire Three Months.|A weekly responder in abdominal pain is defined as a ≥30% improvement from baseline in the weekly average abdominal pain score on a 10-point scale (0=no pain - 10= worst possible pain). A weekly responder in stool consistency is defined as ≥50% reduction in the number of days in a week with stool consistency of Type 6 or 7 compared with baseline using the Bristol Stool Scale. Monthly responders are subjects who are weekly responders in both abdominal pain and stool consistency for at least two out of four weeks.|3 months|Intent to Treat Population included all randomized subjects who ingested at least one dose of study drug. Analysis of study data was based on observed cases, missing data remained missing.||participants|||Number
823906|NCT01177410|Secondary|Proportion of Subjects Who Are Monthly Responders in Both Abdominal Pain and Stool Consistency for at Least 2 Months During the 3-month Treatment Period|A weekly responder in abdominal pain is defined as a ≥30% improvement from baseline in the weekly average abdominal pain score on a 10-point scale (0=no pain - 10= worst possible pain). A weekly responder in stool consistency is defined as ≥50% reduction in the number of days in a week with stool consistency of Type 6 or 7 compared with baseline using the Bristol Stool Scale. Monthly responders are subjects who are weekly responders in both abdominal pain and stool consistency for at least two out of four weeks.|3 months|Intent to Treat Population included all randomized subjects who ingested at least one dose of study drug. Analysis of study data was based on observed cases, missing data remained missing.||participants|||Number
823907|NCT01168973|Other Pre-specified|Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs) or Died|Data presented are the number of participants who experienced at least 1 TEAE, Grade 3, 4, or 5 TEAE, treatment-emergent serious adverse event (SAE), TEAE leading to discontinuation of study treatment (ramucirumab/placebo or docetaxel), and TEAE leading to death. Clinically significant events were defined as treatment-emergent SAEs and other non-serious adverse events (AEs) regardless of causality. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.|First infusion up to 30 days following last infusion (up to Cycle 38, 21 days/cycle)|Safety population: Randomized participants who received any quantity of study drug, grouped by the treatment they actually received.||participants|||Number
823908|NCT01168973|Secondary|Number of Participants With Anti-Ramucirumab Antibodies|The number of participants who had treatment-emergent or follow-up emergent anti-drug antibodies (ADA) is reported. Participants with treatment-emergent ADA were defined as participants who had any sample from baseline through Cycle 5 pre-infusion that was a 4-fold increase (2 dilution increase) in immunogenicity titer over the baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20). Participants with follow-up emergent ADA were defined as participants who had any sample during 30 days post last infusion that was a 4-fold increase (2 dilution increase) in immunogenicity titer over the baseline titer.|Baseline, prior to infusion for week 4 and 8 (cycles 3 and 5), and 30 days following last infusion (up to Cycle 38, 21 days/cycle)|Randomized participants who received any quantity of study treatment, grouped by the treatment they actually received, who had a baseline and at least 1 post-baseline ADA assessment.||participants|||Number
823909|NCT01168973|Secondary|Maximum and Minimum Serum Concentrations (Cmax and Cmin) of Ramucirumab||Prior to infusion and 1 hour following infusion for 4 and 8 (cycles 3 and 5 at 21 days/cycle)|Participants assigned to the ramucirumab and docetaxel arm at randomization, who had evaluable ramucirumab pharmacokinetic (PK) data to calculate Cmax and Cmin.||micrograms per milliliter (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
823917|NCT01168986|Primary|Immediate Change in Pain Sensitivity Using a Numeric Pain Rating Scale|Participants rated the pain associated with a standardized (51 degrees Celsius) thermal stimulus applied to the plantar surface of their dominant foot using a 0 to 100 numeric pain rating scale with 0 indicating no pain at all and 100 indicating the most intense pain sensation imaginable.|Immediate within session change pre to post intervention|The numbers of participants analyzed is not consistent with number of participants enrolled in the study due to missing data||units on a scale||Standard Deviation|Mean
830649|NCT01231841|Secondary|Comparison of the Level of IS as Assessed by Immuknow Assay in Responders and Non-responders||Every 2 weeks for 3 months beginning on day 1 of therapy and then monthly (for a total of 6 months)||||||
823910|NCT01168973|Secondary|Change From Baseline to 30-Day Follow-Up Visit on European Quality of Life Questionnaire-5 Dimension (EQ-5D) Health State Scores|The EQ-5D is a quality-of-life instrument that consists of 2 parts. The first part (Health State Index score) allowed participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a scale from 1 to 3 (no problem, some problems, and extreme problems, respectively). These combinations of attributes were converted into a weighted Health State Index score according to a United Kingdom population-based algorithm; the possible values for the Health State Index score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension). The second part of the EQ-5D was a VAS that allowed participants to rate their present health condition. Possible EQ-5D VAS scores ranged from 0 (worst imaginable health state) to 100 (best imaginable health state).|Baseline, 30 days following last infusion (up to Cycle 38, 21 days/cycle)|Randomized participants grouped according to their assigned treatment at randomization, who had an EQ-5D assessment at a baseline and 30 days post treatment.||units on a scale||Standard Deviation|Mean
823911|NCT01168973|Secondary|Maximum Improvement on Lung Cancer Symptom Scale (LCSS)|The LCSS consisted of 9 items: 6 items focused on lung cancer symptoms [loss of appetite, fatigue, cough, dyspnea (shortness of breath), hemoptysis (blood in sputum), and pain] and 3 items were global items (symptom distress, interference with activity level, and global quality of life). Participant responses to each item were measured using visual analogue scales (VAS) with 100-mm lines. A higher score for any item represented a higher level of symptoms/problems. The Average Symptom Burden Index (ASBI) was the mean of the 6 symptom items of the LCSS, and the Total LCSS was the mean of all 9 LCSS items. ASBI and Total LCSS were not computed for a participant if he/she had 1 or more missing values for the 6 and 9 items, respectively. Maximum improvement in LCSS scores, ASBI, and Total LCSS score was the largest decrease from baseline for each variable, which was the smallest (most negative or smallest positive) non-missing value among all change from baseline values for each variable.|Baseline, Day 21 of each cycle, and 30 days following last infusion (up to Cycle 38, 21 days/cycle)|Randomized participants grouped according to their assigned treatment at randomization, who had a baseline and at least 1 post-baseline LCSS score.||mm||Standard Deviation|Mean
823912|NCT01168973|Secondary|Percentage of Participants Achieving Disease Control (Disease Control Rate)|Participants achieved disease control if they had a best overall response of PR, CR or stable disease (SD). According to RECIST v1.1, PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter; CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels (if tumor markers were initially above the ULN). SD was neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started. The percentage of participants who achieved disease control=(number of participants with CR, PR, or SD)/(number of participants assessed)*100.|Baseline to measured PD (up to 29 months)|ITT population: All randomized participants grouped according to their assigned treatment at randomization.||percentage of participants||95% Confidence Interval|Number
823913|NCT01168973|Secondary|Percentage of Participants Achieving an Objective Response (Objective Response Rate)|Participants achieved an objective response if they had a best overall response of partial response (PR) or complete response (CR). According to RECIST v1.1, PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter; CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels [if tumor markers were initially above the upper limit of normal (ULN)]. The percentage of participants who achieved an objective response=(number of participants with CR or PR)/(number of participants assessed)*100.|Baseline to measured PD (up to 29 months)|ITT population: All randomized participants grouped according to their assigned treatment at randomization.||percentage of participants||95% Confidence Interval|Number
823914|NCT01168973|Secondary|Progression-Free Survival (PFS) Time|PFS time was the time from randomization until the date of objectively determined progressive disease (PD) or death due to any cause, whichever occurred first. According to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), PD was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the 20% relative increase, the sum must have also demonstrated an absolute increase of at least 5 millimeters (mm). The appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions was also considered progression. Participants without objectively determined PD who were alive at the end of the follow-up period (or lost to follow‑up) were censored on the date of the participant's last complete radiographic tumor assessment; if no baseline or post-baseline radiologic assessment was available, the participant was censored at the date of randomization.|Randomization to measured PD or date of death from any cause (up to 29 months)|ITT population: All randomized participants grouped according to their assigned treatment at randomization. Participants censored: ramucirumab and docetaxel arm = 70 participants; placebo and docetaxel arm = 42 participants.||months||95% Confidence Interval|Median
823915|NCT01168973|Primary|Overall Survival|Overall survival was the time from randomization until the date of death from any cause. Participants who were alive at the end of the follow-up period (or lost to follow‑up) were censored on the last date the participant was known to be alive.|Randomization to date of death from any cause (up to 34 months)|Intent-to-Treat (ITT) population: All randomized participants grouped according to their assigned treatment at randomization. Participants censored: ramucirumab and docetaxel arm = 200 participants; placebo and docetaxel arm = 169 participants.||months||95% Confidence Interval|Median
823916|NCT01168986|Secondary|Change From Baseline in Neck Extension Range of Motion at 2 Weeks|change in neck extension range of motion over a 2 week period|2 weeks|The numbers of participants analyzed is not consistent with number of participants enrolled in the study due to missing data||degrees||Standard Deviation|Mean
823938|NCT01169311|Secondary|Quality of Life, Mental Component|quality of life, SF36 measure as change from baseline the scoring ranges from 0 to 100 with 0 = complete mental activity limitation; while 100 = capable of mental activity without limitation|Baseline, 30 days post op|Only subjects who completed the SF-36 questionnaire were included in the analysis. The number of participants reflects 24/27 subjects completed the questionnaire.||units on a scale||Standard Deviation|Mean
823918|NCT01168986|Primary|2 Week Change in Disability on the Neck Disability Index|A functional questionnaire (the neck disability index) to assess self report of disability related to neck pain. The neck disability index is a 10 item questionnaire assessing neck pain related disability. Items are scored from 0 to 5 with the total score doubled resulting in a final score from 0 to 100 with higher scores indicating higher levels of perceived disability.|2 weeks|The numbers of participants analyzed is not consistent with number of participants enrolled in the study due to missing data||2 week change in units a scale||Standard Deviation|Mean
823919|NCT01168986|Primary|2 Week Change in Pain Score on a Numeric Rating Scale|a 101 point numeric rating scale of neck pain with 0 indicating no pain at all and 100 indicating the worst pain imaginable|2 weeks|The numbers of participants analyzed is not consistent with number of participants enrolled in the study due to missing data||units on a scale||Standard Deviation|Mean
823920|NCT01168999|Secondary|Change From Baseline at 2 Weeks in Low Back Left Sidebending Range of Motion|Low back left sidebending range of motion was measured in degrees using a gravity inclinometer|Change from Baseline at 2 weeks|||degrees||Standard Deviation|Mean
823921|NCT01168999|Secondary|Change From Baseline at 2 Weeks in Low Back Right Sidebending Range of Motion|Low back right sidebending range of motion was measured in degrees using a gravity inclinometer|Change from Baseline at 2 weeks|||degrees||Standard Deviation|Mean
823922|NCT01168999|Secondary|Change From Baseline at 2 Weeks in Low Back Extension Range of Motion|Low back extension range of motion was measured in degrees using a gravity inclinometer|Change from Baseline at 2 weeks|||degrees||Standard Deviation|Mean
823923|NCT01168999|Secondary|Change From Baseline at 2 Weeks in Low Back Flexion Range of Motion|Low back flexion range of motion was measured in degrees using a gravity inclinometer|Change from Baseline at 2 weeks|||degrees||Standard Deviation|Mean
823924|NCT01168999|Primary|Change in Pain Sensitivity From Baseline to Immediately Following the Assigned Intervention as Measured by a Visual Analog Scale|"Participants received a standard thermal stimulus to the bottom of their foot prior to and immediately following their assigned intervention. Participants rated their pain in response to this thermal stimulus using a 101 mm visual analog scale with 0 mm indicating no pain at all and 100 mm indicating the worst pain imaginable."|baseline and immediately following their assigned intervention during the initial session|||units on a scale||Standard Deviation|Mean
823925|NCT01168999|Primary|Change From Baseline at 2 Weeks in Disability as Measured by the Oswestry Disability Index|The Oswestry Disability Index is a 10 item questionnaire measuring low back pain related disability. Individual item scores range from 0 to 5. Scores on all items are summed and multiplied by 2 to provide a percentage ranging between 0 to 100 with higher scores indicating greater low back pain related disability.|Change from Baseline at 2 weeks|||units on a scale||Standard Deviation|Mean
823926|NCT01168999|Primary|Change From Baseline at 2 Weeks in Clinical Pain as Measured by a Numeric Rating Scale|A 101 point numeric rating scale with 0= no pain at all to 100= worst pain imaginable of low back pain|Change from Baseline at 2 weeks|||units on a scale||Standard Deviation|Mean
823927|NCT01168999|Primary|Expectation for Treatment Effectiveness|how helpful participants expect the assigned intervention will be in decreasing their low back pain|baseline|||percent expecting less pain|||Number
823928|NCT01168999|Primary|Believability of Placebo|Assess whether or not participants receiving the placebo are blinded to the fact they are receiving the placebo as indicated by the percentage of participants in each arm of the study believing they received SMT|baseline|||percentage of participants|||Number
823929|NCT01169038|Primary|Change in Absolute FVC From Baseline to Post Completion of 8 Weeks of Antibiotic Therapy.|The primary endpoint was improvement in absolute FVC from baseline to completion of therapy. Spirometry testing was performed using a standardized calibrated laptop spirometer, Flowscreen II USA Spirometer (VIASYS Healthcare Inc., Yorba Linda, CA). The volume accuracy of the spirometer was checked daily using a three liter calibration syringe. Each subject was given at least three attempts and the greatest measurement for absolute FVC and Forced Expiratory Volume (FEV1) at baseline, four week, and eight week assessments was recorded.|8 weeks|In the ITT analysis, we included the values from the last measured value for those who did not complete the trial. We analyzed the measured value at 8 weeks among those subjects who completed 8 weeks of therapy in the per protocol analysis.||liters||Standard Deviation|Mean
823930|NCT01169064|Secondary|Patient Dressing Cost|Total cost of dressings per group based on 1 dressing per patient|Postoperative|||dollars|||Number
823931|NCT01169064|Secondary|Infection Rate Adjusted for Maternal BMI||6 weeks postpartum|||percentage of participants||95% Confidence Interval|Number
823932|NCT01169064|Primary|Silver Treatment Efficacy|As measured by number of patients with postop infections at 6 wks|6 weeks postpartum|||participants|||Number
823933|NCT01169103|Primary|Change in Soluble Intercellular Adhesion Molecule-1 (sICAM) Over 6 Months|Soluble intercellular adhesion molecule-1 (sICAM) was used as a surrogate marker of cardiovascular risk|Baseline and 6 months|||ng/mL||Standard Deviation|Mean
823934|NCT01169103|Primary|Change in High-sensitivity C-reactive Protein (Hs-CRP) Over 6 Months|As a marker of cardiovascular risk, hs-CRP will be assessed at baseline and 6 months to assess the rate at which hs-CRP levels change with rhGH therapy.|Baseline and 6 months|||mg/L||Standard Deviation|Mean
823935|NCT01169103|Primary|Changes in Lipid Panel|Lipid profile will be obtained using established methods. Total Cholesterol, Triglycerides, LDL and HDL measurements will be obtained at baseline, and then at the six-month visits to determine the rate at which lipid measures change with rhGH therapy|Baseline and 6 months|||mg/dL||Standard Deviation|Mean
823936|NCT01169103|Secondary|Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) Score|Homeostasis model assessment of insulin resistance (HOMA-IR) was used as a validated measure of insulin resistance. A 2-hour Oral Glucose Tolerance Test (OGTT) using 1.75 gram/kilogram of oral glucose (maximum 75 gram) will be performed at baseline and six months after administration of rhGH/placebo/ no therapy. Fasting insulin and glucose will be used to determine HOMA-IR: [fasting glucose (mmol/l) x fasting insulin (µU/ml)]/22.5]|Baseline and 6 months|||HOMA-IR score||Standard Deviation|Mean
823937|NCT01169103|Primary|Change in Visceral and Subcutaneous Abdominal Adipose Tissue Over 6 Months|Visceral adipose tissue (VAT) and subcutaneous abdominal adipose tissue (SAT) were assessed using single slice MR imaging (MRI)|Baseline and 6 months|Due to scheduling difficulties one no treatment subject did not perform the MRI portion of the study at either the baseline or the 6 month visit.||mm^2||Standard Deviation|Mean
823939|NCT01169311|Secondary|Quality of Life, Physical Component|Physical component score SF36 scale measured as change from baseline the scoring ranges from 0 to 100 with 0 = unable to do anything while 100 = capable of physical activity without limitation|baseline, 30 days post op|Only subjects who completed the SF-36 questionnaire were included in the analysis. The number of participants reflects 24/27 subjects completed the questionnaire.||units on a scale||Standard Deviation|Mean
823940|NCT01169311|Secondary|Post Operative Pain|Post operative pain measured by 11 point visual analog scale, measured as change from baseline The scale range is 0-10, where 0 = no pain and 10 = worst possible pain|baseline, 30 days post op|||units on a scale||Standard Deviation|Mean
823941|NCT01169311|Secondary|Incidence of Stapler Malfunction or Misfires||about 20 minutes for procedure|||participants|||Number
823942|NCT01169311|Secondary|Time to Return to Normal Activity||30 days post op|||Days||Standard Deviation|Mean
823943|NCT01169311|Secondary|Length of Stay|length of time between time of admission and time of discharge|Day 0, time of discharge minus time of admission|||Minutes||Standard Deviation|Mean
823944|NCT01169311|Secondary|Intra-Operative Bleeding Requiring Intervention|Incidence of intervention for intra-operative staple-line bleeding|Day 0 - time of surgery|||participants|||Number
823945|NCT01169311|Secondary|OR Time|Duration of procedure|Day 0 - Time of stop minus time of start|||minutes||Standard Deviation|Mean
823946|NCT01169311|Primary|Uneventful Creation of a Functional Staple Line at First Firing of Device|Successful creation of staple line at first firing of device during hemorrhoidopexy|about 20 minutes for procedure|||participants|||Number
823947|NCT01169467|Secondary|Mean Arterial Blood Pressure (MAP) Variability in Patients With Secondary Brain Injury|Improved physiologic Response. A lower variability of mean Arterial Blood pressure during treatment would be considered an improved physiologic response. A higher variability of mean Arterial Blood pressure during treatment would be considered a worse physiologic response. Variability was assessed and listed as the standard deviation of all measurements within 24 hours.|Baseline to 24 hours|Everyone who started the trial was included except for seventeen subjects had incomplete data and could not be included in this analysis.||mmHg||Standard Error|Mean
823948|NCT01169467|Secondary|Cerebral Perfusion Pressure Changes in Patients With Secondary Brain Injury|Improved physiologic Response. A higher cerebral perfusion pressure during treatment would be considered an improved physiologic response. A lower cerebral perfusion pressure during treatment would be considered a worse physiologic response.|Baseline to 24 hours|Everyone who completed the trial was included except for fourteen subjects had incomplete data and could not be included in this analysis.||mmHg||Standard Error|Mean
823949|NCT01169467|Secondary|Amount of Sedative/Analgesic Used During Treatment in Patients With Secondary Brain Injury|Improved physiologic Response. A lower use of sedatives or analgesic during treatment would be considered an improved physiologic response. An increase in the use of sedatives or analgesic during treatment would be considered a worse physiologic response.|24 hours|Everyone who started the trial was included except for one subject had incomplete data and could not be included in this analysis.||mg/ml||Standard Error|Mean
823950|NCT01169467|Primary|Change in Pressure Reactivity Index (PRx)|"Using computational methods, the PRx was determined by calculating the correlation coefficient between 20 consecutive, time-averaged data points (60-second periods) of ICP and Arterial Blood Pressure (ABP).
A positive PRx correlation suggests impaired cerebrovascular pressure reactivity, that is, passive transmission of changes in ABP to ICP. A negative PRx correlation indicates good pressure reactivity. Any change in ABP produces inverse changes in ICP."|Baseline to 24 hours|Everyone who completed the trial was included except for nineteen subjects had incomplete data and could not be included in this analysis.||Pressure Reactivity Index||Standard Error|Mean
823951|NCT01169467|Primary|Variability of Intracranial Pressure (ICP)|Variability of intracranial pressure was assessed and listed as the standard deviation of all measurements within 24 hours. Variability was assessed and listed as the standard deviation of all measurements within 24 hours|Baseline to 24 hours|Everyone who completed the trial was included except for fourteen subjects had incomplete data and could not be included in this analysis.||mmHg||Standard Error|Mean
823952|NCT01169493|Secondary|Left Ventricular End-diastolic Size||6 months|Data not collected.||cubic cm||Standard Error|Mean
823953|NCT01169493|Secondary|Left Ventricular Ejection Fraction (LVEF)||6 months|Data not collected.||percent||Standard Deviation|Mean
823954|NCT01169493|Secondary|NYHA Function Class|The New York Heart Association (NYHA) Functional Classification places patients in one of four categories based on how much they are limited during physical activity. Class I means there is no limitation of physical activity and Class IV means a person is unable to carry on any physical activity without discomfort/symptoms of heart failure at rest.|6 months|||units on a scale||Standard Deviation|Mean
823955|NCT01169493|Secondary|6-minute Walk Distance|6-minute walk distance was the distance that a participant could walk in 6 minutes.|6 months|All participants who completed the six month period for VVI-40, RV DDD-40, Bi-V DDD-40 regardless of which arm they are randomized to. Participants may be counted as completing more than one period.||meters||Standard Deviation|Mean
823956|NCT01169493|Secondary|Minnesota Quality of Life Questionnaire|This is a standardized method for assessing quality of life in patients with heart failure. It asks 21 questions and measures the impact HF has on a subject's life. Each question is rated 0-5. The total score for the 21 items can range from 0 to 105. Higher scores indicate more burden of disease on quality of life.|6 months|All participants who completed the six month period for VVI-40, RV DDD-40, Bi-V DDD-40 regardless of which arm they are randomized to. Participants may be counted as completing more than one period.||units on a scale||Standard Deviation|Mean
823957|NCT01169493|Secondary|Arrhythmic Events|To determine if pacing mode impacts the frequency of ventricular arrhythmias, the incidence of ventricular tachyarrhythmia episodes on device interrogation will be compared between treatment group assignments. An episode will be considered ventricular arrhythmia if it lasts longer than 30 seconds or requires anti-tachycardia pacing or high voltage device therapy for termination.|6 months|All participants who completed the six month period for VVI-40, RV DDD-40, Bi-V DDD-40 regardless of which arm they are randomized to. Participants may be counted as completing more than one period.||participants|||Number
823958|NCT01169493|Secondary|Secondary Echocardiographic Endpoints|Comparisons of the derived velocity-time integral calculated on the aortic continuous wave Doppler-spectrogram, RV end-diastolic size, RV EF, mitral and tricuspid regurgitation severity, and estimated RV systolic pressure.|6 months|Data not collected.|||||
823959|NCT01169493|Primary|The Primary Endpoint of the Trial Will be a Comparison of the Proportion of Patients in Each of the Three Treatment Groups Who Demonstrate Positive LV Remodeling, Defined as a Decrease in LV End Systolic Diameter of >5mm.||6 months|All participants who completed the six month period for VVI-40, RV DDD-40, Bi-V DDD-40 regardless of which arm they are randomized to. Participants may be counted as completing more than one period.||percentage of participants|||Number
823960|NCT01169519|Secondary|Hemodynamic Safety and Efficacy|Assessment of pulmonary vascular resistance|10 minutes after completion of sildenafil infusion|||Wood units * m^2||Inter-Quartile Range|Median
823961|NCT01169519|Primary|Maximum Sildenafil Plasma Concentration|Assessment of peak sildenafil plasma concentration.|5 minutes after completion of sildenafil infusion|3 patients were enrolled in this group but in 1 participant, an inadequate plasma sample volume prevented accurate determination of sildenafil concentration.||ng/mL||Standard Deviation|Mean
823962|NCT01169558|Secondary|Efficacy: Progression-free Survival|Progression-free survival (PFS) was measured as the time from start of first bevacizumab administration to investigator-assessed progression or death, whichever occurred first. Progression was defined using RECIST v1.0, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Reported is the median time of PFS.|Up to approximately 3 years|158 participants from the ITT population were included in the analysis. Four participants were excluded from the ITT population due to protocol deviation.||months||95% Confidence Interval|Median
823963|NCT01169558|Secondary|Efficacy: Time to Disease Progression|Time to disease progression was measured as the time from start of first bevacizumab administration to investigator-assessed progression. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. For participants without disease progression at the end of the study, date and time to progression were censored at the last investigator assessment. Reported is the median time to disease progression.|Up to approximately 3 years|158 participants from the ITT population were included in the analysis. Four participants were excluded from the ITT population due to protocol deviation.||months||95% Confidence Interval|Median
823964|NCT01169558|Secondary|Efficacy: Overall Survival|Overall survival was measured as the time from start of first bevacizumab administration to death. For participants who were alive at the end of the study, data on survival were censored at the time of the last contact. Reported is the median duration of overall survival.|Up to approximately 3 years|158 participants from the ITT population were included in the analysis. Four participants were excluded from the ITT population due to protocol deviation.||months||95% Confidence Interval|Median
823965|NCT01169558|Primary|Safety: Number of Participants With Serious and Specific Adverse Events|A serious adverse event was defined as any experience that suggested a significant hazard, contraindication, side effect, or precaution, and fulfilled any of the following criteria: fatal (resulted in death), life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was medically significant or required intervention to prevent any of the other outcomes listed here. Specific adverse events (Spec AEs) included the following: hypertension, bleeding/hemorrhage, proteinuria, wound healing complications, thrombosis/thrombus/embolism (t/t/e), thrombosis/thrombus/embolism - vascular access, gastrointestinal perforation, and infusion (injection) site reaction.|Up to approximately 3 years|The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was primarily used for the reporting of safety information.||participants|||Number
823966|NCT01169610|Secondary|Tolerability|Tolerability will be defined by the number of adverse events experienced by patients.|Two years||||||
823967|NCT01169610|Secondary|Prolonged Smoking Abstinence|"Self-reported all tobacco abstinence since two weeks after target quit date (TQD) which will be during their 28-day stay in the IAP on day 8 of varenicline therapy. Negative response to the question, “Have you used any type of tobacco, even a puff, for 7 consecutive days or at least once each week on two consecutive weeks since xx/xx/xxxx?” Note: xx/xx/xxxx corresponds to the date two weeks after the target quit date (TQD).
Biochemically-confirmed abstinence at the visit for which prolonged abstinence is being obtained."|Two years||||||
823968|NCT01169610|Secondary|7-day Point Prevalence Smoking Abstinence|Negative response to the question, “Have you used any type of tobacco, even a puff, in the past 7 days.” This will be a self-reported outcome biochemically-confirmed with exhaled-air carbon monoxide (CO) < 8 parts per million (ppm) during the medication phase.|Two years||||||
823969|NCT01169610|Primary|Heavy Drinking Days|Number of drinking days > 5 drinks/day for men and > 4 drink/day for women. This will be a self-reported outcome.|Two years||||||
823970|NCT01169610|Primary|Continuous Alcohol Abstinence|No consumption of alcohol (not even a single drink) during the specified interval of time. This will be a self-reported outcome.|Two years||||||
823971|NCT01169649|Primary|Overall Response.|Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|every 12 weeks|||participants|||Number
823972|NCT01169675|Secondary|Tumour Shrinkage|Tumour shrinkage is defined as the maximum percentage decrease from baseline in the sum of the longest diameters of target lesions.|Every 6 weeks before week 48 and every 12 weeks after week 48 until progression|Treated Set: all patients that received treatment of Afatinib or Pemetrexed and who were evaluated for the longest diameter of the target lesions.||participants|||Number
823973|NCT01169675|Secondary|Progression Free Survival (PFS)|PFS was defined as the time from the first treatment to the occurence of tumour progression or death, whichever came first. It was assessed according to RECIST version 1.1 criteria.|Every 6 weeks before week 48 and every 12 weeks after week 48 until progression|Treated Set includes all patients that received treatment of Afatinib or Pemetrexed||months||95% Confidence Interval|Median
823974|NCT01169675|Secondary|Disease Control|Disease Control is defined as complete response, partial response, or stable disease according to the response evaluation criteria in solid tumours (RECIST) version 1.1.|Every 6 weeks before week 48 and every 12 weeks after week 48 until progression|Treated Set includes all patients that received treatment of Afatinib or Pemetrexed||participants|||Number
823975|NCT01169675|Secondary|Objective Response (OR)|"Objective Response is defined as complete response or partial response according to the response evaluation criteria in solid tumours (RECIST) version 1.1.
Complete Response (CR): disappearance of all non-target lesions and normalization of tumor marker level; Partial Response (PR): at least 30% decrease of the sum of longest diameter (LD) of target lesions; Progressive Disease (PD): at least a 20% increase in the sum of LD of target lesions together with an absolute increase in the sum of LD of at least 5 millimeters; Stable Disease (SD): neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for PD."|Every 6 weeks before week 48 and every 12 weeks after week 48 until progression|Treated Set includes all patients that received treatment of Afatinib or Pemetrexed||participants|||Number
823976|NCT01169675|Secondary|Investigator Defined Dose Limiting Toxicity (DLT) During All Courses of Treatment, Treated Set|Occurence of DLT during all courses of treatment with Afatinib at two different dose schedules in combination with the standard established dose of pemetrexed (500 mg/m2).|DLT were assessed during all cycles of treatment|Treated Set includes all patients that received treatment of Afatinib or Pemetrexed||participants|||Number
823977|NCT01169675|Primary|Investigator Defined Dose Limiting Toxicity (DLT) During First Course of Treatment, Treated Set|Occurence of DLT during the first course of treatment to determine the maximum tolerated dose (MTD) of Afatinib at two different dose schedules in combination with the standard established dose of pemetrexed (500 mg/m2).|DLT were assessed during the first cycle (days 1-21)|Treated Set includes all patients that received treatment of Afatinib or Pemetrexed that who were evaluable for MTD determination||participants|||Number
823978|NCT01169701|Secondary|Percentage of Participants With Biopsy-proven Acute Rejection (BPAR), Graft Loss, Death and Lost to Follow up|The incidence of BPAR, graft loss, death and lost to follow-up events was calculated using relative frequency.|Month 24|Intent to Treat (ITT): The ITT included participants who received at least one dose of study medication and at least one post baseline LVMI value.||Percentage of participants|||Number
823979|NCT01169701|Secondary|Change From Baseline in Cardiovascular Biomarkers, C-reactive Protein (CRP)|Blood samples were collected to analyze CRP. A negative change from baseline indicates improvement.|Baseline, month 6, month 24|Participants from the safety analysis set were considered for this analysis. The safety analysis set included participants who received at least one dose of study medication. For each time point, only participants, who had values at both baseline and the given time point, were analyzed for that time point.||mg/dl||Standard Deviation|Mean
823980|NCT01169701|Secondary|Change From Baseline in the Cardiovascular Biomarker, Type 1 Procollagen Amino-terminal-propeptide (PINP)|Blood samples were collected to analyze PCR. A negative change from baseline indicates improvement.|Baseline, month 6, month 24|Participants from the safety analysis set were considered for this analysis. The safety analysis set included participants who received at least one dose of study medication. For each time point, only participants, who had values at both baseline and the given time point, were analyzed for that time point.||ug/l||Standard Deviation|Mean
823981|NCT01169701|Secondary|Change From Baseline in the Cardiovascular Biomarker, N-terminal Pro-brain Natriuretic Peptide Fraction (NT-proBNP)|Blood samples were collected to analyze NT-proBNP. A negative change from baseline indicates improvement.|Baseline, month 6, month 24|Participants from the safety analysis set were considered for this analysis. The safety analysis set included participants who received at least one dose of study medication. For each time point, only participants, who had values at both baseline and the given time point, were analyzed for that time point.||pg/mL||Standard Deviation|Mean
823982|NCT01169701|Secondary|Change From Baseline in the Cardiovascular Biomarker, Myeloperoxidase (MPO)|Blood samples were collected to analyze MPO. A negative change from baseline indicates improvement.|Baseline, month 6, month 24|Participants from the safety analysis set were considered for this analysis. The safety analysis set included participants who received at least one dose of study medication. For each time point, only participants, who had values at both baseline and the given time point, were analyzed for that time point.||U/mL||Standard Deviation|Mean
823983|NCT01169701|Secondary|Change From Baseline in the Cardiovascular Biomarker, Glycosylated Hemoglobin (HbA1c)|Blood samples were collected to analyze HbA1c. A negative change from baseline indicates improvement.|Baseline, month 6, month 24|Participants from the safety analysis set were considered for this analysis. The safety analysis set included participants who received at least one dose of study medication. For each time point, only participants, who had values at both baseline and the given time point, were analyzed for that time point.||Percentage of HbA1c||Standard Deviation|Mean
823984|NCT01169701|Secondary|Change From Baseline in Cardiovascular Biomarkers: Troponin I and Collagen Type 1 C-telopeptide (ICTP)|Blood samples were collected to analyze Troponin I and collagen type 1 C-telopeptide (ICTP). A negative change from baseline indicates improvement.|Baseline, month 6, month 24|Participants from the safety analysis set were considered for this analysis. The safety analysis set included participants who received at least one dose of study medication. For each time point, only participants, who had values at both baseline and the given time point, were analyzed for that time point.||ng/ml||Standard Deviation|Mean
823985|NCT01169701|Secondary|Renal Function as Measured by Estimated Glomerular Filtration Rate (eGFR)|Estimated GFR was caluclated using the modification of diet in renal disease (MDRD) formula.|Month 6, month 12, month 24|Participants from the safety analysis set were considered for this analysis. The safety analysis set included participants who received at least one dose of study medication. For each time point, only participants, who had values at the given time point, were analyzed for that time point.||mL/min/1.73m^2||Standard Deviation|Mean
823986|NCT01169701|Secondary|Renal Function as Measured by Creatinine Clearance|Creatinine clearance was calculated using the Cockroft-Gault formula.|Month 6, month 12, month 24|Participants from the safety analysis set were considered for this analysis. The safety analysis set included participants who received at least one dose of study medication. For each time point, only participants, who had values at the given time point, were analyzed for that time point.||mg/min||Standard Deviation|Mean
824036|NCT01170221|Primary|Early Clinical Response Rate|Responder: No increase in lesion surface area from baseline and oral temperature ≤37.6°C|48-72 hours|The ITT analysis set includes data from all randomized participants.||Responders|||Number
823987|NCT01169701|Secondary|Renal Function Measured by Serum Creatinine|Serum samples were collected to analyze serum creatinine.|Month 6, month 12, month 24|Participants from the safety analysis set were considered for this analysis. The safety analysis set included participants who received at least one dose of study medication. For each time point, only participants, who had values at the given time point, were analyzed for that time point.||mg/dl||Standard Deviation|Mean
823988|NCT01169701|Secondary|Percentage of Participants With Major Cardiovascular Events (MACE)|The percentage of participants who experienced MACE were reported. MACE included acute myocardial infarction, insertion or replacement of implantable defibrillator, peripheral vascular disorders, congestive heart failure, coronary artery bypass, other events, percutaneous coronary intervention and stroke.|Month 24|The Intent to Treat (ITT) analysis set: The ITT included participants who received at least one dose of study medication and had at least one post baseline LVMI value.||Percentage of participants|||Number
823989|NCT01169701|Secondary|Pulse Wave Velocity (PWV)|Utilizing the SphygmoCor Device, ECG leads placed at the carotid and femoral arteries provided the measure of the pulse wave at that particular arterial location. The distance between the two vascular beds divided by the pulse wave time shift provided a measure of the pulse wave velocity.|Month 6, month 24|Participants from the safety analysis set were considered for this analysis. The safety analysis set included participants who received at least one dose of study medication. For each time point, only participants, who had values at the given time point, were analyzed for that time point.||m/sec||Standard Deviation|Mean
823990|NCT01169701|Secondary|Change From Baseline in Mean 24 Hour Systolic and Diastolic Blood Pressure|Blood pressure was measured using ambulatory blood pressure monitoring (ABPM). A negative change from baseline indicates improvement.|Baseline, Month 6, month 12, month 24|Participants from the safety analysis set were considered for this analysis. The safety analysis set included participants who received at least one dose of study medication. For each time point, only participants, who had values at both baseline and the given time point, were analyzed for that time point.||mmHg||Standard Deviation|Mean
823991|NCT01169701|Primary|Change From Baseline in Left Ventricular Mass Index (LVMI)|Left ventricular hypertrophy grade was assessed by echocardiogram where the left ventricular mass index was calculated. The presence of LVM was defined as > 49.2 g/m^2.7 in men and >46.7 g/m^2.7 in women. A negative change from baseline indicates improvement.|Baseline, Month 24|Participants from the Intent to Treat (ITT) analysis set, who had both baseline and month 24 values, were analyzed. The ITT included participants who received at least one dose of study medication and at least one post baseline LVMI value.||g/m^2.7||Standard Deviation|Mean
823992|NCT01169753|Primary|"Number of Participants With Fatigue Worst BFI Score"|"Efficacy defined by fatigue worst score from the Brief Fatigue Inventory (BFI) after each 2-week treatment period, using a 0 - 10 scale with 10 being WORST level of fatigue."|After each 2 week treatment|No analysis completed, study stopped due to slow accrual with only one participant.|||||
823993|NCT01169779|Other Pre-specified|Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia|Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the patient required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.|First dose of study drug up to 3 days after the last dose administration|Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.||participants|||Number
823994|NCT01169779|Secondary|Percentage of Patients Requiring Rescue Therapy During Main 24-Week Period|Routine fasting self-monitored plasma glucose (SMPG) and central laboratory FPG (and HbA1c after week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after week 12) were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG >250 milligram/deciliter (mg/dL) (13.9 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG >220 mg/dL (12.2 mmol/L), and from Week 12 to Week 24: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >8.5%. For a patient to be included in mITT population, both baseline and at least 1 post baseline on-treatment assessment for at least 1 efficacy variable, were required.|Baseline up to Week 24|mITT population.||percentage of participants|||Number
823995|NCT01169779|Other Pre-specified|Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline on-treatment assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.||percentage of participants|||Number
823996|NCT01169779|Secondary|Change From Baseline in Glucose Excursion at Week 24|Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the standardized meal test, before study drug administration. Change was calculated by subtracting Baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest.|Baseline, Week 24|Subgroup for standardized meal test. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with Baseline and at least 1 post-baseline glucose excursion assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
823997|NCT01169779|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 24|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline on-treatment assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.||percentage of participants|||Number
823998|NCT01169779|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline on-treatment assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.||percentage of participants|||Number
823999|NCT01169779|Secondary|Change From Baseline in Body Weight at Week 24|Change was calculated by subtracting Baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline on-treatment assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.||kilogram||Standard Error|Least Squares Mean
824000|NCT01169779|Secondary|Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Week 24|The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. Change was calculated by subtracting Baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest.|Baseline, Week 24|Subgroup for standardized meal test. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline 2-hour PPG assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
824001|NCT01169779|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Change was calculated by subtracting Baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 1 day after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline on-treatment assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using last observation carried forward (LOCF). Here, number of patients analyzed = patients with baseline and at least 1 post-baseline FPG assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
824002|NCT01169779|Primary|Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|Absolute change = HbA1c value at Week 24 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline on-treatment assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population:all randomized patients who received at least 1 dose;had baseline,at least 1 post-baseline efficacy assessment, irrespective of compliance with study protocol/procedures. Last observation carried forward used. Number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.||percentage of hemoglobin||Standard Error|Least Squares Mean
824003|NCT01169987|Secondary|WPAI Questionnaire: Mean Percentage of Activity Impairment Due to Psoriasis for All Participants and Broken Down by Adalimumab Treatment Retention Status|Activity impairment due to psoriasis (the extent to which psoriasis affected the ability to perform usual daily activities) is presented as the mean percentage of activity impairment, calculated as 100*scale value of WPAI question 6 (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. For the purpose of the analysis of the evolution of parameters over time, follow-up visits were classified into time-windows (TWs), based upon the number of days between onset of adalimumab treatment and the date of each subsequent visit: TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730).|Baseline, TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730); last observation (up to 24 months)|ITT set: all participants enrolled in the study who received at least 1 dose of adalimumab, and for whom any follow-up data were available; n=number of participants with an assessment at given time point.||percentage of activity impairment||Standard Deviation|Mean
824004|NCT01169987|Secondary|WPAI Questionnaire: Mean Percentage of Total Work Productivity Impairment (TWPI) Due to Psoriasis for All Participants and Broken Down by Adalimumab Treatment Retention Status|The mean percentage of TWPI due to psoriasis (based on the WPAI questionnaire) is presented, calculated as: Absenteeism (%) + extent to which psoriasis decreased productivity (%)* [number of hours worked / (number of hours of work missed due to psoriasis + number of hours worked)]. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. For the purpose of the analysis of the evolution of parameters over time, follow-up visits were classified into time-windows (TWs), based upon the number of days between onset of adalimumab treatment and the date of each subsequent visit: TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730).|Baseline, TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730); last observation (up to 24 months)|ITT set: all participants enrolled in the study who received at least 1 dose of adalimumab, and for whom any data follow-up were available; n=number of participants with an assessment at given time point.||percentage of TWPI||Standard Deviation|Mean
824037|NCT01170247|Primary|Onset of Sedation|Minutes it takes until the patient is cooperative enough for the procedure|Every 60 seconds through study completion|||Participants|||Count of Participants
824516|NCT01175018|Secondary|Difference Between the Anakinra Arm and the Placebo Arm in Change in Left Ventricular End-diastolic Volume Indices From Baseline to Follow up Exam at Cardiac Magnetic Resonance Imaging||10-14 weeks|Applies only to subset of patients with magnetic resonance imaging (MRI) at baseline and 10-14 weeks.||mL/m2||Inter-Quartile Range|Median
824005|NCT01169987|Secondary|WPAI Questionnaire: Mean Percentage of Impairment While Working Due to Psoriasis (Presenteeism) for All Participants and Broken Down by Adalimumab Treatment Retention Status|Presenteeism (the extent to which psoriasis decreased productivity) is presented as the mean percentage of impairment while working due to psoriasis, and calculated as: 100*scale value of question 5 on the WPAI (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. For the purpose of the analysis of the evolution of parameters over time, follow-up visits were classified into time-windows (TWs), based upon the number of days between onset of adalimumab treatment and the date of each subsequent visit: TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730).|Baseline, TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730); last observation (up to 24 months)|ITT set: all participants enrolled in the study who received at least 1 dose of adalimumab, and for whom any follow-up data were available.||percentage of impairment while working||Standard Deviation|Mean
824006|NCT01169987|Secondary|Work Productivity and Activity Impairment (WPAI) Questionnaire: Mean Percentage of Work Time Missed (Absenteeism) for All Participants and Broken Down by Adalimumab Treatment Retention Status|Absenteeism, presented as the mean percentage of work time missed due to psoriasis (as reported on the WPAI), and calculated as: 100*number of hours of work missed due to psoriasis / (number of hours of work missed due to psoriasis + number of hours worked). WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. For the purpose of the analysis of the evolution of parameters over time, follow-up visits were classified into time-windows (TWs), based upon the number of days between onset of adalimumab treatment and the date of each subsequent visit: TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730).|Baseline, TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730); last observation (up to 24 months)|ITT set: all participants enrolled in the study who received at least 1 dose of adalimumab, and for whom any follow-up data were available; n=number of participants with assessment at given time point.||percentage of work time missed||Standard Deviation|Mean
824007|NCT01169987|Secondary|DLQI: Percentage of Participants in DLQI Categories for All Participants and Broken Down by Adalimumab Treatment Retention Status|DLQI is a participant-reported outcome consisting of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot (score of 2), a little (score of 1), or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. The following scoring categories present the effect on participant's life: 0-1 no effect at all; 2-5 small effect; 6-10 moderate effect; 11-20 very large effect; 21-30 extremely large effect. Follow-up visits were classified into time windows (TWs), based upon the number of days between onset of adalimumab treatment and the date of each subsequent visit: TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730).|Baseline, TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730); last observation (up to 24 months)|ITT set: all participants enrolled in the study who received at least 1 dose of adalimumab, and for whom any follow-up data were available; n=number of participants with an assessment at given time point.||percentage of participants|||Number
824008|NCT01169987|Secondary|Dermatology Life Quality Index (DLQI): Mean Score for All Participants and Broken Down by Adalimumab Treatment Retention Status|DLQI score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each question are: very much (3), a lot (2), a little (1), or not at all (0). The total DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. For the purpose of the analysis of the evolution of parameters over time, follow-up visits were classified into time-windows, based upon the number of days between onset of adalimumab treatment and the date of each subsequent visit: TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730).|Baseline, TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730); last observation (up to 24 months)|ITT set: all participants enrolled in the study who received at least 1 dose of adalimumab, and for whom any follow-up data were available; n=number of participants with an assessment at given time point.||units on a scale||Standard Deviation|Mean
824009|NCT01169987|Secondary|Physician's Global Assessment (PGA): Percentage of Participants in Regrouped PGA Categories for All Participants and Broken Down by Adalimumab Treatment Retention Status|"The PGA was an evaluation of a participant's psoriasis on a 6-point scale: clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5), which were then regrouped into the 2 categories Clear/Minimal or Mild/Moderate/Severe/Very Severe (M/Md/S/VS), and presented as the percentage of participants in each. For the purpose of the analysis of the evolution of parameters over time, follow-up visits were classified into time-windows (TWs), based upon the number of days between onset of adalimumab treatment and the date of each subsequent visit: TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730)."|Baseline, TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730); last observation (obs.; up to 24 months)|ITT set: all participants enrolled in the study who received at least 1 dose of adalimumab, and for whom any follow-up data were available; n=number of participants with an assessment at given time point.||percentage of participants|||Number
824117|NCT01179490|Secondary|Pharmacokinetic Parameters (t1/2)|Plasma pharmacokinetics (t1/2) of unchanged bendamustine|On Day 1 only|||h||Standard Deviation|Mean
824010|NCT01169987|Secondary|Mean Percent Affected Body Surface Area (BSA) For All Participants and Broken Down by Adalimumab Treatment Retention Status|Clinical psoriasis evaluations by the investigator of percentage of affected BSA. For the purpose of the analysis of the evolution of parameters over time, follow-up visits were classified into time-windows (TWs), based upon the number of days between onset of adalimumab treatment and the date of each subsequent visit: TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730).|Baseline, TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730); last observation (up to 24 months)|ITT set: all participants enrolled in the study who received at least 1 dose of adalimumab, and for whom any follow-up data were available; n=number of participants with an assessment at given time point.||percentage of affected BSA||Standard Deviation|Mean
824011|NCT01169987|Secondary|PASI: Percentage Improvement Change Categories From Baseline for All Participants and Broken Down by Adalimumab Treatment Retention Status|Percentage of participants who achieved ≥ 50%, 75%, 90% or 100% reduction (improvement) from Baseline in PASI score (PASI50, PASI75, PASI90, PASI100). Four anatomic sites (head, upper extremities, trunk, and lower extremities) were assessed for erythema, induration (plaque thickness), and desquamation (scaling) as seen on the day of the examination. The severity of each sign was assessed using a 5-point scale: 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. PASI percentage improvement=100*(PASI score at Baseline - score at follow-up visit) / PASI score at Baseline. For the purpose of analysis of the evolution of parameters over time, follow-up visits were classified into time-windows (TWs), based on the number of days between onset of adalimumab treatment and the date of each subsequent visit: TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730).|Baseline, TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730); last observation (up to 24 months)|ITT set: all participants enrolled in the study who received at least 1 dose of adalimumab, and for whom any follow-up data were available; n=number of participants with an assessment at given time point.||percentage of participants|||Number
824012|NCT01169987|Secondary|Psoriasis Area and Severity Index (PASI): Mean Percentage Improvement From Baseline for All Participants and Broken Down by Adalimumab Treatment Retention Status|Four anatomic sites (head, upper extremities, trunk, and lower extremities) were assessed with PASI for erythema, induration (plaque thickness), and desquamation (scaling) as seen on the day of the examination. The severity of each sign was assessed using a 5-point scale: 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. PASI percentage improvement=100*(PASI score at Baseline – score at follow-up visit) / PASI score at Baseline. For the purpose of the analysis of the evolution of parameters over time, follow-up visits were classified into time-windows (TWs), based upon the number of days between onset of adalimumab treatment and the date of each subsequent visit: TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730).|Baseline, TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730); last observation (up to 24 months)|ITT set: all participants enrolled in the study who received at least 1 dose of adalimumab, and for whom any follow-up data were available; n=number of participants with an assessment at Baseline and given time point.||percentage improvement||Standard Deviation|Mean
824013|NCT01169987|Primary|Adalimumab Treatment Retention Status|Percentage of participants with an adalimumab treatment status of continuous, early intermittent, late intermittent, permanently discontinued, or other. Continuous=initiated on adalimumab, had no treatment interruption period, still on treatment at study termination, and completed the study. Early intermittent=initiated on adalimumab 40 mg, treated every other week (EOW) for < 112 days (16 weeks) after initiation of treatment, with afterwards ≥ 1 treatment interruption period of ≥ 70 consecutive days, on treatment at study termination, and completed the study. Late intermittent=initiated on adalimumab 40 mg, treated EOW for ≥ 112 days (16 weeks) after initiation of treatment, with afterwards ≥ 1 treatment interruption period of at least 70 consecutive days, on treatment at study termination, and completed the study. Permanently discontinued=received ≥ 1 dose of adalimumab and stopped adalimumab treatment permanently. Other=participants not belonging to any of the previous groups.|Month 24/ Early Termination visit|Intention to Treat (ITT) set: all participants enrolled in the study who received at least 1 dose of adalimumab, and for whom any follow-up data were available.||percentage of participants|||Number
824014|NCT01170039|Secondary|Change in Scores on the Patient Assessment of Constipation Quality of Life (PAC-QOL) Questionnaire|The difference in the scores on the self-reported Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaire. The quality of life is measured by the by the overall scores on the Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaire, a validated 28-item questionnaire measuring quality of life as it pertains to constipation. The 28 items are grouped into four subscales, 1) worries and concerns, 2) physical discomfort, 3) psychosocial discomfort, and 4) satisfaction. A 5-point Likert response scale, ranging from 0 (Not at all/None of the time) to 4 (Extremely/ All of the time), is used. The subscale scores vary from 0 to 4 and the total (global) score ranges from 0 to 4. A lower score indicates better quality of life (QOL).|Screening, 8 weeks|7 subjects in the Lubiprostone arm and 7 subjects in the placebo arm did not complete the Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaire and therefore no data was analyzed for these subjects.||scores on a scale||Standard Deviation|Mean
824015|NCT01170039|Secondary|Number of Subjects With Daily Abdominal Discomfort|The number of subjects experiencing abdominal discomfort was recorded weekly.|1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks|The number of participants in both arms was analyzed by Intention-to-Treat (ITT).||participants|||Number
824016|NCT01170039|Secondary|Efficacy, Measured by the Duration of Colonic Transit Time as Measured by the SmartPill pH Capsule|The duration of colonic transit time in hours was measured by the SmartPill pH Capsule. Colonic transit time is the time interval from the cecal entry of the capsule to anal expulsion and was measured in hours.|Baseline, 4 weeks|Intention to treat population.||hours||Standard Deviation|Mean
824118|NCT01179490|Secondary|Pharmacokinetic Parameters (AUC)|Plasma pharmacokinetics (AUC) of unchanged bendamustine|On Day 1 only|||ng・h/mL||Standard Deviation|Mean
824017|NCT01170039|Primary|Efficacy, Measured by the Average Number of Spontaneous Bowel Movements (SBMs) Per Week|The average number of spontaneous bowel movements calculated per week from baseline to 8 weeks was recorded. The number of spontaneous bowel movements was recorded by the subjects in a daily stool diary and the weekly average was calculated. Spontaneous bowel movements are bowel movements within a 24 hour period independent of rescue medication use within the previous week.|1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks|Two subjects in the Lubiprostone arm did not complete the daily stool diary at baseline. No data was analyzed for these two subjects.||spontaneous bowel movements||Standard Deviation|Mean
824018|NCT01170091|Secondary|Clinical Global Impressions-Global Improvement (CGI-I)|"CGI-I comprises of 7 categories including very much improved, much improved, minimally improved, no change, minimally worse, much worse and very much worse."|before and after the treatment with Mirapex (at least 4 weeks after the end of titration)|Patients whose CGI-I were assessed at the baseline and at 4 weeks after the end of titration. Efficacy Data Set (Intent to Treat)||patients|||Number
824019|NCT01170091|Secondary|Patient-Global Impressions (PGI-I)|"PGI comprises of 7 categories including very much improved, much improved, minimally improved, no change, minimally worse, much worse and very much worse."|before and after the treatment with Mirapex (at least 4 weeks after the end of titration)|Patients whose PGI were assessed at the baseline and at 4 weeks after the end of titration. Efficacy Data Set (Intent to Treat)||patients|||Number
824020|NCT01170091|Secondary|International Restless Legs Syndrome Rating Scale (IRLS) Change After 4 Weeks of Mirapex Treatment|"a change in 10-item scale rated by the patient on 5 levels with a minimum (none) sum score of 0 to maximum (very severe) sum score of 40"|before and after the treatment with Mirapex (at least 4 weeks after the end of titration)|Patients whose IRLS scores were assessed at the baseline and at 4 weeks after the end of titration. Efficacy data set (Intent to Treat)||Units on a scale||Standard Deviation|Mean
824021|NCT01170091|Primary|Number of Reported Adverse Events|If there is a dose titration, another 4 weeks should be followed up|Up to 4 weeks|Patients with RLS who took at least one dose of Mirapex - Safety Analysis Set||cases|||Number
824022|NCT01170117|Primary|Psychological Change|Comparison of psychological change as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS), in patients receiving olanzapine compared with those receiving placebo. The Y-BOCS is divided into two sections: obsessive and compulsive. The scores for each section range from 1 to 20. The overall scores are obtained from adding scores for the two sections, to obtain a range between 2-40. A lower score reflects improvement/ fewer obsessive compulsive symptoms. A score of 25 or more is considered moderately severe, a score of 30 or more is considered severe, and a score of more than 35 is considered very severe.|Weekly during 16-week intervention and twice during 8-week follow-up|||YBOCs score units per month||Standard Deviation|Mean
824023|NCT01170117|Primary|Rate of Weight Change|Comparison of rate of weight change between patients receiving olanzapine and those receiving placebo|Weekly during 16-week trial and twice during 8 weeks follow-up|Patients assigned to receive placebo or olanzapine for 16 weeks.||Change in BMI (kg/m2) per month||Standard Error|Mean
824024|NCT01170208|Secondary|Incidence of Severe or Serious Hypoglycemia.||January 2011||||||
824025|NCT01170208|Secondary|Reduction in Fructosamine.||January 2011||||||
824026|NCT01170208|Secondary|Reduction in HbA1c.||January 2011||||||
824027|NCT01170208|Secondary|Clinical Evaluation of ―Over-ride‖ to Determine if the Reason for ―Over-ride‖ Will Affect a Change in the Algorithm.||January 2011||||||
824028|NCT01170208|Primary|Weekly Mean Blood Glucose||Twelve week period from week 4 to week 16|Per Protocol||mg/dL||Standard Deviation|Mean
824029|NCT01170221|Secondary|Change From Baseline in Patient-reported Pain, by Study Visit|0=no pain, 10=worst pain Only 1 visit per participant for Day 4-6, only 1 visit for Day 7-9, and only 1 visit for Day 10-13.|Multiple|The Intent to Treat analysis set includes data from all randomized participants.||units on a scale||Standard Deviation|Mean
824030|NCT01170221|Secondary|Investigator's Assessment of Clinical Response at the Day 7 Visit|Clinical improvement was defined as improvement in overall clinical status.|Day 7|The Intent to Treat analysis set includes data from all randomized participants.||participants|||Number
824031|NCT01170221|Secondary|Investigator's Assessment of Clinical Response at the 48-72 Hour Visit|Clinical improvement was defined as improvement in overall clinical status.|48-72 Hour Visit|The Intent to Treat analysis set includes data from all randomized participants.||participants|||Number
824032|NCT01170221|Secondary|To Compare the Investigator's Assessment of Clinical Success at the Post Treatment Evaluation Visit in the Clinically Evaluable-Post Treatment Evaluation Analysis Set|Clinical success defined as resolution/near resolution of most disease-specific signs and symptoms, absence/near resolution of systemic signs of infection, no new signs, symptoms, or complications attributable to the ABSSSIs so no further antibiotic therapy was required for the treatment of the primary lesion.|Post-Treatment Evaluation (7-14 days after the End of Therapy)|All randomized patients who received the minimal study therapy, completed EOT and PTE assessments, no concomitant systemic antibiotic therapy through PTE, and had no confounding events or factors.||participants|||Number
824033|NCT01170221|Secondary|Investigator’s Assessment of Clinical Success at the Post Treatment Evaluation Visit|Clinical success defined as resolution/near resolution of most disease-specific signs and symptoms, absence/near resolution of systemic signs of infection, if present at baseline, no new signs, symptoms, or complications attributable to the ABSSSIs so no further antibiotic therapy was required for the treatment of the primary lesion.|Post-Treatment Evaluation (7-14 days after the End of Therapy)|The Intent to Treat analysis set included data from all randomized participants.||participants|||Number
824034|NCT01170221|Secondary|Clinical Response at 48-72 Hours That is Sustained at the End of Therapy Visit in the Clinically Evaluable-End of Therapy Analysis Sets|Responder: No increase in lesion surface area from baseline and oral temperature ≤37.6°C|EOT Day 11|All randomized patients receiving minimal study therapy, completed 48-72 Hour and EOT assessments, no concomitant systemic antibiotic therapy through EOT, and had no confounding events or factors||participants|||Number
824035|NCT01170221|Secondary|Clinical Response at 48-72 Hours That is Sustained at the End of Therapy Visit.|Responder: No increase in lesion surface area from baseline and oral temperature ≤37.6°C.|Day 11|The ITT analysis set includes data from all randomized participants.||participants|||Number
824119|NCT01179490|Secondary|Pharmacokinetic Parameters (Tmax)|Plasma pharmacokinetics (tmax) of unchanged bendamustine|On Day 1 only|||h||Standard Deviation|Mean
824038|NCT01170273|Primary|Change in Short Physical Performance Battery Test Score|The short physical performance battery (SPPB) examines 3 areas of lower extremity function: static balance test, gait speed test and getting in and out of a chair test. The total SPPB score is the sum of the scores of the 3 components and can range from 0 to 12, with 0 reflecting severe limitations and 12 minimal or no limitations. The ranges for each subscale are: balance (0-4), gait speed (0-4), sit-to-stand (0-4). In all the subscales, 0 reflects worse outcome and 4 best outcome.|baseline and 9 months|||units on a scale||Standard Deviation|Mean
824039|NCT01177553|Secondary|Fetal/Neonatal/Infant Survival of the AGA Fetus 6 Months After Birth, Comparing the SLPCV (Selective Laser Photocoagulation of Communicating Vessels) and Expectant Management Groups.||6 months||||||
824040|NCT01177553|Primary|Survival|Effects of surgery or expectant management on postnatal neurological morbidity of the AGA baby. The primary comparison will be between SLPCV (selective laser photocoagulation of communicating vessels) and expectant management.|6 months|||percentage of AGA babies who survived|||Number
824041|NCT01177670|Secondary|Safety Endpoints|The Adiana System will be evaluated for safety on the basis of the occurrence of adverse events which are related to the study device, unanticipated or serious.|At one and two years|Intent to treat||participants|||Number
824042|NCT01177670|Primary|Pregnancy Rate - for Women Informed They May Rely on the Adiana System for Contraception.|The primary efficacy endpoints are the one and two year pregnancy rates among women who have hysterosalpingogram (HSG)-proven bilateral occlusion and are informed that they may rely on the Adiana System for contraception.|At one and two years|Efficacy results were not tabulated due to the early termination of the study. Only 169 of the planned 1,000 subjects (16.9%) were enrolled therefore the study is defined as incomplete, as fewer than one-third of the intended patients were enrolled.|||||
824043|NCT01177709|Secondary|Insulin Level|fasting serum insulin uIU/ml.|baseline, 4 weks, 8 weeks, 12 weeks|||uIU/ml||Standard Error|Mean
824044|NCT01177709|Secondary|Glucose Levels|Fasting glucose|baseline, 4 weeks, 8 weeks, 12 weeks|||mg/dL||Standard Error|Mean
824045|NCT01177709|Primary|Weight (wt) in Pounds (Lbs)..|Patients weight in pounds|baseline, 4 weeks, 8 weeks, 12 weeks|||weight(wt) in pounds(lbs)||Standard Error|Mean
824046|NCT01177722|Secondary|Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine|Solicited Injection Site Reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability. Grade 3 was defined as: Pain, cries when injected limb is moved or movement of the limb is reduced; Erythema and Swelling, ≥ 5 cm; Pyrexia (Temperature), ≥ 39.6ºC; Vomiting, ≥ 6 episodes/24 hours or requiring parenteral hydration; Crying, > 3 hours; Somnolence, sleeping most of time or difficult to wake up; Anorexia, refuses ≥ 3 feed/meals or refuses most feeds/meals; and Irritability, inconsolable.|Day 0 up to 7 post each vaccination|Solicited injection site and systemic reactions were assessed in all participants who received at least one dose of study vaccine (Safety Analysis Set).||Participants|||Number
824047|NCT01177722|Secondary|Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine|Solicited Injection Site Reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia,and Irritability. Grade 3 was defined as: Pain, cries when injected limb is moved or movement of the limb is reduced; Erythema and Swelling, ≥ 5 cm; Pyrexia, (Temperature) ≥ 39.6°C; Vomiting, ≥ 6 episodes/24 hours or requiring parenteral hydration; Crying, > 3 hours; Somnolence, sleeping most of time or difficult to wake up; Anorexia, refuses ≥ 3 feed/meals or refuses most feeds/meals; and Irritability, inconsolable.|Day 0 up to 7 after each dose|Solicited injection site and systemic reactions were assessed in all participants who received at least one dose of study vaccine (Safety Analysis Set).||Participants|||Number
824048|NCT01177722|Secondary|Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine|Antibodies were measured by toxin neutralization test for Diphtheria (D); enzyme-linked immunosorbent assay (ELISA) for Tetanus (T), Pertussis toxoid (PT), and Filamentous hemagglutinin (FHA); neutralization assay for Poliovirus types 1, 2, and 3; chemiluminescence detection for Hepatitis B (Hep B), and Farr type radioimmunoassay for Haemophilus influenza type b (PRP).|Day 0 (pre-vaccination) and 30 days post-dose 3|GMTs were assessed in all subjects who did not have any protocol violation that might interfere with primary criteria evaluation (Per Protocol Population).||Titers||95% Confidence Interval|Geometric Mean
824049|NCT01177722|Primary|Number of Participants With Seroprotection or Vaccine Response After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine|Seroprotection was defined as titers ≥ 0.01 IU/mL for Diphtheria (D) and Tetanus (T); ≥ 10 IU/mL for Hep B; ≥ 0.15 µg/mL for PRP, and ≥ 8 (1/dil) for Poliovirus. Vaccine response for PT and FHA were defined as a titer ≥ lower limit of quantitation (LLOQ) in initially seronegative participants, or at least persistence (post-vaccination titer ≥ pre-vaccination titer) in initially seropositive subjects (titer ≥ LLOQ).|30 Days post-dose 3|Seroprotection and vaccine response were assessed in all subjects who did not have any protocol violation that might interfere with primary criteria evaluation (Per Protocol Population).||Participants|||Number
824050|NCT01177722|Primary|Geometric Mean Titers (GMTs) of Anti-Hepatitis B Before and After 3 Dose Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T Batch A, B, or C, or Infanrix Hexa™|Antibodies against Hepatitis B (Hep B) were measured by chemiluminescence detection.|Day 0 (pre-vaccination) Dose 1 and 30 days post-vaccination|GMTs were assessed in all subjects who did not have any protocol violation that might interfere with primary criteria evaluation (Per-Protocol Population).||Titers||95% Confidence Interval|Geometric Mean
824120|NCT01179490|Secondary|Pharmacokinetic Parameters (Cmax)|Plasma pharmacokinetics (Cmax) of unchanged bendamustine|On Day 1 only|||ng/mL||Standard Deviation|Mean
824055|NCT01177800|Other Pre-specified|Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability|The AE is defined as any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. A serious adverse event (SAE) was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); significant disability; congenital (occurred before birth, due to parent’s genetic input) anomaly.|Baseline up to end of study (Week 26)|Safety Population included all participants randomly assigned to infliximab or placebo group.||participants|||Number
824056|NCT01177800|Other Pre-specified|Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 26|The DLQI is a dermatology-specific QOL instrument designed to assess impact of disease on a participants QOL. It is a 10-item questionnaire that, in addition to evaluating overall, QOL can be used to assess 6 different aspects: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships and treatment. Questions scored on a 4-point Likert scale: 0 (not relevant), 1 (a little), 2 (a lot), and 3 (very much). Scores of individual items (0-3) were added to yield a total score (0-30); higher score = greater impairment of participants QOL.|Baseline and Week 26|ITT population included all participants randomly assigned to Infliximab or placebo group. 'n' included those participants who were evaluable for this measure at specific time points.||units on a scale||Standard Deviation|Mean
824057|NCT01177800|Secondary|Percentage of Participants With Static Physician Global Assessment (PGA) Score Less Than Equal to 1 at Week 10|The Static physician global assessment (PGA) determines psoriasis lesions overall at given time point. Overall lesions graded for I (0= no evidence of plaque elevation to 5= severe plaque elevation), E (0 = no evidence of E, hyperpigmentation may be present to 5=dusky to deep red coloration), S (0 = no evidence of S to 5 = severe; very thick tenacious scale predominates). Sum of 3 scales divided by 3 gives final PGA score. Range for final score is 0 = cleared, except for residual discoloration, 1 = minimal, 2 = mild, 3=moderate, 4= marked and 5= severe; Scores should be rounded to the nearest whole number. If total ≤1.49, score = 1; if total≥ 1.50, score = 2. Percentage of participants with static PGA score <= 1 at week 10 were reported.|Week 10|ITT population included all participants randomly assigned to Infliximab or placebo group.||percentage of participants|||Number
824058|NCT01177800|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 10|The DLQI is a dermatology-specific quality of life (QOL) instrument designed to assess impact of disease on a participants QOL. It is a 10-item questionnaire that, in addition to evaluating overall, QOL can be used to assess 6 different aspects: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships and treatment. Questions scored on a 4-point Likert scale: 0 (not relevant), 1 (a little), 2 (a lot), and 3 (very much). Scores of individual items (0-3) were added to yield a total score (0-30); higher score = greater impairment of participants QOL.|Baseline and Week 10|ITT population included all participants randomly assigned to Infliximab or placebo group. Here 'n' included those participants who were evaluable for this measure at specific time points.||units on a scale||Standard Deviation|Mean
824059|NCT01177800|Primary|Percentage of Participants Who Achieved a Greater Than Equal to 75 Percent Response in Psoriasis Area and Severity Index (PASI)|The PASI score is based on the assessment of the erythema (e), induration (I), scaling (S), and the body is divided into 4 regions head, trunk, upper extremities, lower extremities. The assessment was done on 4-point scale (where, 0 = none, 1 = slight, 2 = moderate, 3 = severe, and 4 = very severe). The total possible score ranges from 0 (no disease) to 72 (maximal disease). Participants with no less than 75 percent relative Baseline improvement in the PASI scores are considered to be PASI 75 responders.|Week 10|Intent to treat (ITT) population included all participants randomly assigned to Infliximab or placebo group.||percentage of participants|||Number
824060|NCT01177813|Other Pre-specified|Confirmed Hypoglycaemic Adverse Events|"Confirmed hypoglycaemic events refer to all hypoglycaemic events, that had a glucose value <= 70 ml/dL or where assistance was required.
Symptomatic hypoglycaemic events were to be reported as adverse events. Patients can be counted in more than one category."|From first drug intake until 7 days after last medication intake, up to 219 days|Treated set (actual) including all patients treated with at least 1 dose of randomised trial medication with some treatment switchers (1 from Empa25 to placebo; 1 patient got Empa 10 at least with one mis-allocated kit) and open-label set||percentage of participants|||Number
824061|NCT01177813|Secondary|Change From Baseline to Week 24 in Systolic and Diastolic Blood Pressure (SBP and DBP)|"The term “baseline” refers to the last observation before the start of randomised trial treatment (or of open-label treatment for the open-label arm).
In this endpoint, the measured values show unadjusted values, whereas the statistical analyses show adjusted values. Statistics for open-label group are descriptive.
For blood pressure, data following changes in antihypertensive therapy is censored, in the same way that data following initiation of rescue medication is censored."|Baseline and week 24|FAS and open-label set, last observation carried forward without values following a change in antihypertensive therapy (LOCF- H) was used as the imputation rule||mmHg||Standard Error|Mean
824062|NCT01177813|Secondary|Change From Baseline to Week 24 in Body Weight|"The term “baseline” refers to the last observation before the start of randomised trial treatment (or of open-label treatment for the open-label arm).
In this endpoint, the measured values show unadjusted values, whereas the statistical analyses show adjusted values. Statistics for open-label group are descriptive."|Baseline and day 169|FAS (LOCF) and open-label set (LOCF)||kg||Standard Error|Mean
824063|NCT01177813|Primary|Change From Baseline in Glycosylated Haemoglobin (HbA1c) After 24 Weeks|"The term “baseline” refers to the last observation before the start of randomised trial treatment (or of open-label treatment for the open-label arm).
In this endpoint, the measured values show unadjusted values, whereas the statistical analyses show adjusted values. Statistics for open-label group are descriptive."|Baseline and day 169|FAS and open-label set, last observation carried forward (LOCF) was used as the imputation rule for both sets||percent of HbA1c||Standard Error|Mean
824064|NCT01179048|Secondary|Time From Randomisation to Each Individual Component of the Composite Microvascular Outcome and to the Retinopathy and Nephropathy Composite Outcomes Separately.|Time from randomisation to each individual component of the composite microvascular outcome and to the retinopathy and nephropathy composite outcomes separately. The percentage of subjects experiencing each individual component of the composite microvascular outcome are presented.|from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)|All randomised subjects||Percentage of subjects|||Number
824065|NCT01179048|Secondary|Time From Randomisation to First Occurrence of a Composite Microvascular Outcome|"Time from randomisation to first occurrence of a composite microvascular outcome, defined as any one of the following:
new onset of persistent macroalbuminuria
persistent doubling of serum creatinine
need for continuous renal replacement therapy
death due to renal disease
need for retinal photocoagulation or treatment with intravitreal agents
vitreous haemorrhage
diabetes-related blindness
The percentage of subjects experiencing a first occurrence of a composite microvascular outcome is presented."|from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)|All randomised subjects.||Percentage of subjects|||Number
824066|NCT01179048|Secondary|Time From Randomisation to Each Individual Component of the Expanded Composite Cardiovascular Outcome|Time from randomisation to each individual component of the expanded composite cardiovascular outcome. The percentage of subjects experiencing each of the individual component of the expanded composite cardiovascular outcome (defined as either cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularisation, hospitalisation for unstable angina or heart failure) is presented.|from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)|All the randomised subjects.||percentage of subjects|||Number
824067|NCT01179048|Secondary|Time From Randomisation to All Cause Death|Time from randomisation to all cause death. The percentage of subjects with a death by any cause (all-cause death) is presented.|from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)|All randomised subjects||percentage of subjects|||Number
824068|NCT01179048|Secondary|Time From Rand. to First Occurrence of an Expanded Composite Cardiovascular Outcome Defined as Either Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke, Revascularisation, Hospitalisation for Unstable Angina or for Heart Failure.|Time from randomisation to first occurrence of an expanded composite cardiovascular outcome defined as either cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularisation, hospitalisation for unstable angina or for heart failure. The percentage of subjects experiencing first occurrence of an expanded composite cardiovascular outcome defined as either cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularisation, hospitalisation for unstable angina or for heart failure is presented.|from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)|All randomised subjects.||percentage of subjects|||Number
824069|NCT01179048|Primary|Time From Randomisation to First Occurrence of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (a Composite Cardiovascular Outcome)|Time from randomisation to first occurrence of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (a composite cardiovascular outcome). The percentage of subjects experiencing a first event of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (a composite cardiovascular outcome) is presented.|from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)|All randomised subjects.||percentage of subjects|||Number
824070|NCT01179113|Secondary|Postoperative Nausea and Vomiting|Number of participants that experienced Postoperative nausea and vomiting using at PACU|1 day|||participants|||Number
824071|NCT01179113|Secondary|Opioid Consumption in PACU Obtained From the Recorded Data|Postoperative use of opioid (Hydromorphone) consumption inside hospital at PACU (recorded by study staff and data obtained from patient charts).|1 day|||mg||Standard Deviation|Mean
824072|NCT01179113|Primary|Post-operative Pain Using Verbal Rating Scale (VRS)|"Verbal Rating Scale goes from 0 to 10, where:
0 indicates= No pain and 10 indicates= The worst possible pain
The information was be recorded by study staff and data obtained from patient and patient charts from post-anesthesia care unit (PACU) stay"|1 day|||Scores on a scale||Standard Deviation|Mean
824121|NCT01179490|Secondary|Number of Abnormalities (Grade ≥3) in Laboratory Test Values|Abnormalities in laboratory test values in overall study period were analyzed. Severity of abnormalities were evaluated using CTCAE.|Up to 2 years|||Events|||Number
824087|NCT01179217|Secondary|The Effect of Oral L-glutamine on Vital Signs|To assess the effect of oral L-glutamine on Vital signs (respiration). Change from Baseline will be reported at Weeks 4, 24, and 48.|Baseline, Week 4, Week 24 and Week 48|Safety Population which includes all patients that took at least one dose of study medication.||breaths/min||Standard Deviation|Mean
824088|NCT01179217|Secondary|Effect of Oral L-glutamine on Vital Signs|To assess the effect of oral L-glutamine on Vital signs (temperature). Change from Baseline will be reported at Weeks 4, 24, and 48.|Baseline, Week 4, Week 24 and Week 48|Safety Population which includes all patients that took at least one dose of study medication.||degree C||Standard Deviation|Mean
824089|NCT01179217|Secondary|The Effect of Oral L-glutamine on Vital Signs|To assess the effect of oral L-glutamine on Vital signs (pulse rate). Change from Baseline will be reported at Weeks 4, 24, and 48.|Baseline, Week 4, Week 24 and Week 48|Safety Population which includes all patients that took at least one dose of study medication.||bpm||Standard Deviation|Mean
824090|NCT01179217|Secondary|The Effect of Oral L-glutamine on Hematological Parameters|To assess the effect of oral L-glutamine on hematological parameters (reticulocyte count), Change from Baseline will be reported at Weeks 4, 24 and 48.|Baseline, Week 4, 24 and 48|Safety population - The safety population included all patients who received at least 1 dose of study medication.||1000 cells/uL||Standard Deviation|Mean
824091|NCT01179217|Secondary|The Effect of Oral L-glutamine on Hematological Parameters|To assess the effect of oral L-glutamine on hematological parameters (hematocrit), Change from Baseline will be reported at Weeks 4, 24 and 48.|Baseline, Week 4, 24 and 48|Safety population - The safety population included all patients who received at least 1 dose of study medication.||% of red blood cells||Standard Deviation|Mean
824092|NCT01179217|Secondary|The Effect of Oral L-glutamine on Vital Signs|To assess the effect of oral L-glutamine on Vital signs (systolic and diastolic blood pressure). Change from Baseline will be reported at Weeks 4, 24, and 48.|Baseline, Week 4, 24, and 48|Safety Population which includes all patients that took at least one dose of study medication.||mm Hg||Standard Deviation|Mean
824093|NCT01179217|Secondary|The Effect of Oral -L-glutamine on Hematological Parameters|To assess the effect of oral L-glutamine on hematological parameters (hemoglobin), Change from Baseline will be reported at Weeks 4, 24 and 48.|Baseline, Week 4, 24 and 48|Safety population - The safety population included all patients who received at least 1 dose of study medication.||g/dL||Standard Deviation|Mean
824094|NCT01179217|Secondary|The Number of Emergency Room/Medical Facility Visits for Sickle Cell Pain|The number of emergency room visits or medical facility visits that occur from Week 0 to Week 48, will be used to evaluate the efficacy of oral L-glutamine as a treatment for sickle cell anemia and beta-0 thalassemia.|48 weeks|Intent-to-Treat Population - Included all patients who were randomized and dispensed study medication.||Number of ER visits||Full Range|Median
824095|NCT01179217|Secondary|The Number of Hospitalizations for Sickle Cell Pain|The number of hospitalizations that occur from Week 0 to Week 48, will be used to evaluate the efficacy of oral L-glutamine as a treatment for sickle cell anemia and beta-0 thalassemia.|48 weeks|Intent-to-Treat Population - Included all patients who were randomized and dispensed study medication.||Number of hospitalizations||Full Range|Median
824096|NCT01179217|Primary|The Number of Occurrences of Sickle Cell Crises|The number of occurrences of protocol-defined sickle cell crises that occur from Week 0 to Week 48 will be used to evaluate the efficacy of oral L-glutamine as a treatment for sickle cell anemia and beta-0 thalassemia.|48 weeks|Intent-to-Treat Population - Included all patients who were randomized and dispensed study medication.||Number of crises||Full Range|Median
824097|NCT01179334|Secondary|Area Under Effect Curve (AUEC) of Standing HR Within 4 Hours Post-dose at Visit 6 (Week 12)|The area under effect curve (AUEC) at each visit of standing HR describes an average within-subject increase in HR from baseline over a time-period of 4 hours post-dose (Note that the area only takes values above the individual baseline for the respective visit into account. The area that would result from a decrease from baseline is not taken into account for the calculation of the area). Baseline was the last HR recorded at and within 30 minutes before intake of study drug.|Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)|PD analysis set||Beats/min*h||Standard Deviation|Mean
824122|NCT01179490|Secondary|Number of Subjects With Abnormality (Grade ≥3) in Laboratory Test Values|"Abnormalities in laboratory test values in overall study period were analyzed. Severity of abnormalities were evaluated using CTCAE.
grade 1 : mild
grade 2 : moderate
grade 3 : severe or medically significant but not immediately life-threatening
grade 4 : life threatening or disabling
grade 5 : death related to AE"|Up to 2 years|||Participants|||Number
824098|NCT01179334|Secondary|Area Under Effect Curve (AUEC) of Supine HR Within 4 Hours Post-dose at Visit 6 (Week 12)|The area under effect curve (AUEC) at each visit of supine HR describes an average within-subject change in HR from baseline over a time-period of 4 hours post-dose (Note that the area only takes values above the individual baseline for the respective visit into account. The area that would result from a decrease from baseline is not taken into account for the calculation of the area). Baseline was the last HR recorded at and within 30 minutes before intake of study drug.|Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)|PD analysis set||Beats/min*h||Standard Deviation|Mean
824099|NCT01179334|Secondary|Area Under Effect Curve (AUEC) of Standing DBP Within 4 Hours Post-dose at Visit 6 (Week 12)|The area under effect curve (AUEC) at each visit of standing DBP describes an average within-subject change in DBP from baseline over a time-period of 4 hours post-dose (Note that the area only takes values below the individual baseline for the respective visit into account. The area that would result from an increase from baseline is not taken into account for the calculation of the area). Baseline was the last DBP recorded at and within 30 minutes before intake of study drug.|Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)|PD analysis set||mmHg*h||Standard Deviation|Mean
824100|NCT01179334|Secondary|Area Under Effect Curve (AUEC) of Supine DBP Within 4 Hours Post-dose at Visit 6 (Week 12)|The area under effect curve (AUEC) at each visit of supine DBP describes an average within-subject change in DBP from baseline over a time-period of 4 hours post-dose (Note that the area only takes values below the individual baseline for the respective visit into account. The area that would result from an increase from baseline is not taken into account for the calculation of the area). Baseline was the last DBP recorded at and within 30 minutes before intake of study drug.|Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)|PD analysis set||mmHg*h||Standard Deviation|Mean
824101|NCT01179334|Secondary|Area Under Effect Curve (AUEC) of Standing SBP Within 4 Hours Post-dose at Visit 6 (Week 12)|The area under effect curve (AUEC) at each visit of standing SBP describes an average within-subject change in SBP from baseline over a time-period of 4 hours post-dose (Note that the area only takes values below the individual baseline for the respective visit into account. The area that would result from an increase from baseline is not taken into account for the calculation of the area). Baseline was the last SBP recorded at and within 30 minutes before intake of study drug.|Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)|PD analysis set||mmHg*h||Standard Deviation|Mean
824102|NCT01179334|Secondary|Area Under Effect Curve (AUEC) of Supine SBP Within 4 Hours Post-dose at Visit 6 (Week 12)|The area under the effect curve (AUEC) at each visit of supine SBP describes an average within-subject change in SBP from baseline over a time-period of 4 hours post-dose (Note that the area only takes values below the individual baseline for the respective visit into account. The area that would result from an increase from baseline is not taken into account for the calculation of the area). Baseline was the last SBP recorded at and within 30 minutes before intake of study drug.|Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)|PD analysis set||mmHg*h||Standard Deviation|Mean
824103|NCT01179334|Secondary|Maximum Change From Baseline in Standing Heart Rate (HR) Within 4 Hours Post-dose at Visit 6 (Week 12)|Heart rate (HR) was measured as standard vital sign parameter. Range allowed in this study: <= 105 beats per minute (bpm) in the first 2 hours after intake of background treatment with sildenafil. The maximum change from baseline at each visit was defined as the within-subject maximum increase from baseline (or zero if baseline was higher than all subsequent HR measurements in that profile) within 4 hours post-dose. Baseline was the last HR recorded at and within 30 minutes before intake of study drug.|Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)|PD analysis set||Beats/min||Standard Deviation|Mean
824104|NCT01179334|Secondary|Maximum Change From Baseline in Supine Heart Rate (HR) Within 4 Hours Post-dose at Visit 6 (Week 12)|Heart rate (HR) was measured as standard vital sign parameter. Range allowed in this study: <= 105 beats per minute (bpm) in the first 2 hours after intake of background treatment with sildenafil. The maximum change from baseline at each visit was defined as the within-subject maximum increase from baseline (or zero if baseline was higher than all subsequent HR measurements in that profile) within 4 hours post-dose. Baseline was the last HR recorded at and within 30 minutes before intake of study drug.|Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)|PD analysis set||Beats/min||Standard Deviation|Mean
824105|NCT01179334|Secondary|Maximum Change From Baseline in Standing Diastolic Blood Pressure (DBP) Within 4 Hours Post-dose at Visit 6 (Week 12)|Diastolic blood pressure (DBP) was measured as standard vital sign parameter. Range allowed in this study: <= 110 mmHg. The maximum change from baseline at each visit was defined as the within-subject maximum decrease from baseline (or zero if baseline was lower than all subsequent DBP measurements in that profile) within 4 hours post-dose. Baseline was the last DBP recorded at and within 30 minutes before intake of study drug.|Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)|PD analysis set||mmHg||Standard Deviation|Mean
824106|NCT01179334|Secondary|Maximum Change From Baseline in Supine Diastolic Blood Pressure (DBP) Within 4 Hours Post-dose at Visit 6 (Week 12)|Diastolic blood pressure (DBP) was measured as standard vital sign parameter. Range allowed in this study: <= 110 mmHg. The maximum change from baseline at each visit was defined as the within-subject maximum decrease from baseline (or zero if baseline was lower than all subsequent DBP measurements in that profile) within 4 hours post-dose. Baseline was the last DBP recorded at and within 30 minutes before intake of study drug.|Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)|PD analysis set||mmHg||Standard Deviation|Mean
824107|NCT01179334|Secondary|Maximum Change From Baseline in Standing Systolic Blood Pressure (SBP) Within 4 Hours Post-dose at Visit 6 (Week 12)|Systolic blood pressure (SBP) was measured as standard vital sign parameter. Range allowed in this study: <= 180 mmHg. In addition, SBP must be >=95 mmHg in the first 2 hours after intake of background treatment with sildenafil. The maximum change from baseline at each visit was defined as the within-subject maximum decrease from baseline (or zero if baseline was lower than all subsequent SBP measurements in that profile) within 4 hours post-dose. Baseline was the last SBP recorded at and within 30 minutes before intake of study drug.|Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)|PD analysis set||mmHg||Standard Deviation|Mean
824123|NCT01179490|Secondary|Number of Adverse Events, Related Adverse Events, Serious Adverse Events, and Related Serious Adverse Events|Adverse events were evaluated using Common Terminology Criteria for Adverse Events (CTCAE) v4.02, Japan Clinical Oncology Group/Japan Society of Clinical Oncology (JCOG/JSCO) version, and were encoded using Medical Dictionary for Regulatory Activities (MedDRA).|Up to 2 years|||Events|||Number
824108|NCT01179334|Primary|Maximum Change From Baseline in Supine Systolic Blood Pressure (SBP) Within 4 Hours Post-dose at Visit 6 (Week 12)|Systolic blood pressure (SBP) was measured as standard vital sign parameter. Range allowed in this study: <= 180 mmHg. In addition, SBP must be >=95 mmHg in the first 2 hours after intake of background treatment with sildenafil. The maximum change from baseline at each visit was defined as the within-subject maximum decrease from baseline (or zero if baseline was lower than all subsequent SBP measurements in that profile) within 4 hours post-dose. Baseline was the last SBP recorded at and within 30 minutes before intake of study drug.|Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)|pharmacodynamic(s) (PD) analysis set||mmHg||Standard Deviation|Mean
824109|NCT01179347|Secondary|Change From Baseline in Revised Cystic Fibrosis Questionnaire (CFQ-R) Score|Different format of CFQ-R are used depending of the patients' age. Adolescent and adult format of CFQ-R is used for patients of 14 years and older, for younger children a parent version and a children format is used. In case parent and children questionnaires were filled out, the children questionnaire is taken into account. Scores were calculated for each domain of the CFQ-R which are presented separately. A score of 100 corresponds to the highest quality of life possible, whereas a score of 0 corresponds to the lowest quality of life possible. Increasing score indicates better health.|Baseline and 12 weeks|FAS reduced to patients having CFQ-R information at baseline and at week 12.||Units on a scale||Standard Deviation|Mean
824110|NCT01179347|Secondary|Percentage of Participants With at Least 1 Pulmonary Exacerbation During Double-blind Treatment|Selected questions from the Respiratory and Systemic Symptoms Questionnaire (RSSQ), the investigator assessment of physical findings and pulmonary function, and the use of intravenous antibiotics as a concomitant therapy were used to determine if a cystic fibrosis-related pulmonary exacerbation had occurred.|12 weeks|FAS reduced to patients having RSSQ information on day 29, 57 or 85.||Percentage of Participants|||Number
824111|NCT01179347|Secondary|Pre-bronchodilator Forced Expiratory Flow Between 25 Percent and 75 Percent of the FVC (FEF25−75) Response|MMRM results. Response was defined as change from baseline in percent of predicted at the end of 12-week double-blind treatment period and is therefore expressed in percent of predicted. FEF25−75 is also known as maximum mid-expiratory flow and was measured before bronchodilator (salbutamol) use. Means are adjusted for treatment, visit, treatment-by-visit interaction, age group (<= 11, >=12), baseline and baseline-by-visit interaction.|Baseline and 12 weeks|Full Analysis Set (FAS) with imputation reduced to patients with observed wash-out compliance. The FAS was defined as all patients in the treated set who had at least 1 baseline pulmonary function test (PFT) measurement and at least 1 post-baseline on-treatment PFT measurement. No patients <5 years of age were included in the FAS.||Percent of predicted||Standard Error|Mean
824112|NCT01179347|Secondary|Trough FVC Response|MMRM results. Response was defined as change from baseline in percent of predicted at the end of 12-week double-blind treatment period and is therefore expressed in percent of predicted. Trough FCV was defined as the pre-dose FVC measured just prior to the administration of randomised treatment. Means are adjusted for treatment, visit, treatment-by-visit interaction, age group (<= 11, >=12), baseline and baseline-by-visit interaction.|Baseline and 12 weeks|Full Analysis Set (FAS) with imputation reduced to patients with observed wash-out compliance. The FAS was defined as all patients in the treated set who had at least 1 baseline pulmonary function test (PFT) measurement and at least 1 post-baseline on-treatment PFT measurement. No patients <5 years of age were included in the FAS.||Percent of predicted||Standard Error|Mean
824113|NCT01179347|Secondary|Forced Vital Capacity (FVC) Area Under the Curve 0-4 Hours (AUC0-4h) Response|MMRM results. Response was defined as change from baseline in percent of predicted at the end of 12-week double-blind treatment period and is therefore expressed in percent of predicted. Means are adjusted for treatment, visit, treatment-by-visit interaction, age group (<= 11, >=12), baseline and baseline-by-visit interaction. FVC AUC0-4h was normalised for time and was calculated using the trapezoidal rule divided by the observation time (4 h).|30 minutes (min) before first dosing of study drug (defined as baseline), at 1 hour (h), 2 h , 3 h, and 4 h post dosing at day 1 and at 30 min before dosing, at 1 hour, 2 h , 3 h, and 4 h post dosing after 12 weeks.|Full Analysis Set (FAS) with imputation reduced to patients with observed wash-out compliance. The FAS was defined as all patients in the treated set who had at least 1 baseline pulmonary function test (PFT) measurement and at least 1 post-baseline on-treatment PFT measurement. No patients <5 years of age were included in the FAS.||Percent of predicted||Standard Error|Mean
824114|NCT01179347|Primary|Trough FEV1 Response|MMRM results. Response was defined as change from baseline in percent of predicted at the end of 12-week double-blind treatment period and is therefore expressed in percent of predicted. Trough FEV1 was defined as the pre-dose FEV1 measured just prior to the administration of randomised treatment. Means are adjusted for treatment, visit, treatment-by-visit interaction, age group (<= 11, >=12), baseline and baseline-by-visit interaction.|Baseline and 12 weeks|Full Analysis Set (FAS) with imputation reduced to patients with observed wash-out compliance. The FAS was defined as all patients in the treated set who had at least 1 baseline pulmonary function test (PFT) measurement and at least 1 post-baseline on-treatment PFT measurement. No patients <5 years of age were included in the FAS.||Percent of predicted||Standard Error|Mean
824115|NCT01179347|Primary|Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve 0-4 Hours (AUC0-4h) Response|Mixed Model Repeated Measurement (MMRM) results. Response was defined as change from baseline in percent of predicted at the end of 12-week double-blind treatment period and is therefore expressed in percent of predicted. Means are adjusted for treatment, visit, treatment-by-visit interaction, age group (<= 11, >=12), baseline and baseline-by-visit interaction. FEV1 AUC0-4h was normalised for time and was calculated using the trapezoidal rule divided by the observation time (4 h).|30 minutes (min) before first dosing of study drug (defined as baseline), at 1 hour (h), 2 h , 3 h, and 4 h post dosing at day 1 and at 30 min before dosing, at 1 hour, 2 h , 3 h, and 4 h post dosing after 12 weeks.|Full Analysis Set (FAS) with imputation reduced to patients with observed wash-out compliance. The FAS was defined as all patients in the treated set who had at least 1 baseline pulmonary function test (PFT) measurement and at least 1 post-baseline on-treatment PFT measurement. No patients <5 years of age were included in the FAS.||Percent of predicted||Standard Error|Mean
824116|NCT01179399|Primary|Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of TAK-960|Adverse events, serious adverse events, assessments of clinical laboratory values, vital sign measurements and electrocardiograms (ECGs)|up to 12 months|Maximum tolerable dose (MTD) and recommended phase 2 dose (RP2D) of TAK-960 were not determined due to sponsor decision to discontinue the study for business reasons.|||||
824124|NCT01179490|Secondary|Number of Subjects With Adverse Event, Related Adverse Event, Serious Adverse Event, and Related Serious Adverse Event|Adverse events were evaluated using Common Terminology Criteria for Adverse Events (CTCAE) v4.02, Japan Clinical Oncology Group/Japan Society of Clinical Oncology (JCOG/JSCO) version, and were encoded using Medical Dictionary for Regulatory Activities (MedDRA).|Up to 2 years|||Participants|||Number
824125|NCT01179490|Secondary|Overall Survival (OS)|OS is the period from the date of patient registration to the date of death.|Up to 2 years|||Days||Full Range|Median
824126|NCT01179490|Secondary|Duration of Response (DOR)|DOR is the period from the date of achieving CR or PR to either the date of recurrence, exacerbation, progression or death.|Up to 2 years|||Days||Full Range|Median
824127|NCT01179490|Secondary|Time to Treatment Failure (TTF)|TTF is the period from patient registration to either the date of recurrence, exacerbation, progression, death or discontinuation of treatment.|Up to 2 years|||Days||Full Range|Median
824128|NCT01179490|Secondary|Progression-Free Survival (PFS)|"PFS is the period from patient registration to either the date of recurrence, exacerbation, progression or death.
Recurrence, exacerbation, progression were assessed from serum M-protein, urine M-protein, serum free light chain (FLC), the percentage of marrow plasma cells, disappearance of clonal plasma cells, plasma cell tumor in soft tissue, and bone lesion."|Up to 2 years|||Days||Full Range|Median
824129|NCT01179490|Secondary|Response Rate (Based on the Modified SWOG Criteria)|"The proportion of subjects evaluated as response (CR + PR) was calculated.
PR (SWOG) requires the followings:
Decline in myeloma protein of ≥25%–<74% in serum myeloma protein
Reduction in 24h urinary myeloma protein of ≥25%–<89%
No increase in skeletal destruction
Serum calcium within normal range"|Up to 36 weeks|||Percentage of participants||95% Confidence Interval|Number
824130|NCT01179490|Secondary|Response Rate (Based on the Bladé Criteria)|"The proportion of subjects evaluated as response (CR + PR) was calculated.
PR (Bladé) requires 1. or all of the others:
Some, but not all, of the criteria for CR are fulfilled
≥50% reduction in the level of the serum monoclonal paraprotein, maintained for a minimum of 6 weeks.
Reduction in 24 h urinary light chain excretion either by ≥90% or to <200 mg, maintained for a minimum of 6 weeks.
For patients with non-secretory myeloma only, ≥50% reduction in plasma cells in a bone marrow aspirate and on trephine biopsy, if biopsy is performed, maintained for a minimum of 6 weeks.
≥50% reduction in the size of soft tissue plasmacytomas (by radiography or clinical examination).
No increase in size or number of lytic bone lesions (development of a compression fracture does not exclude response)."|Up to 36 weeks|||Percentage of participants||95% Confidence Interval|Number
824131|NCT01179490|Secondary|CR Rate Based on the (Bladé) Criteria|"The proportion of subjects evaluated as CR was calculated.
CR (Bladé) requires all of the followings:
Absence of the original monoclonal paraprotein in serum and urine by immunofixation, maintained for a minimum of 6 weeks. The presence of oligoclonal bands consistent with oligoclonal immune reconstitution does not exclude CR.
<5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy, if biopsy is performed. If absence of monoclonal protein is sustained for 6 weeks it is not necessary to repeat the bone marrow, except in patients with non-secretory myeloma where the marrow examination must be repeated after an interval of at least 6 weeks to confirm CR.
No increase in size or number of lytic bone lesions (development of a compression fracture does not exclude response)
Disappearance of soft tissue plasmacytomas"|Up to 36 weeks|||Percentage of participants||95% Confidence Interval|Number
824132|NCT01179490|Secondary|Response Rate (Based on the IMWG Criteria)|"The proportion of subjects evaluated as response [sCR + CR + very good partial response (VGPR) + Partial Response (PR)] was calculated.
VGPR (IMWG): Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100mg per 24 h
PR (IMWG): ≥50% reduction of serum M-protein and reduction in 24 h urinary M-protein by ≥90% or to <200mg per 24 h"|Up to 36 weeks|||Percentage of participants||95% Confidence Interval|Number
824133|NCT01179490|Secondary|CR Rate [Based on the International Myeloma Working Group (IMWG) Criteria]|"The proportion of subjects evaluated as CR [strict CR (sCR) + CR] was calculated.
sCR (IMWG): CR as defined below plus Normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence
CR (IMWG): Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow"|Up to 36 weeks|||Percentage of participants||95% Confidence Interval|Number
824134|NCT01179490|Primary|Complete Response (CR) Rate [Based on the Modified Southwest Oncology Group (SWOG) Criteria]|"The proportion of subjects evaluated as CR was calculated.
CR (modified SWOG) requires all of the followings:
Decline in serum myeloma protein by ≥75% to ≤25 g/L
Reduction in 24 h urinary protein by ≥90% to ≤200 mg/24 h
No increase in skeletal destruction
Serum calcium within normal range
No blood transfusion required in the previous 3 months"|Up to 36 weeks|||Percentage of Participants||95% Confidence Interval|Number
824135|NCT01179516|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from mixed model for repeated measurements (MMRM) ANCOVA with treatment, center, week, treatment-by-week interaction, Baseline SDS total score-by-week as fixed effects.|Baseline and Week 8|Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.||scores on a scale||Standard Error|Least Squares Mean
824136|NCT01179516|Secondary|Percentage of Participants in MADRS Remission at Week 8|Remission is defined as a participant with a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≤10. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.|Week 8|Full analysis set, last observation carried forward was used.||percentage of participants|||Number
824219|NCT01180790|Secondary|Segment 1 and Segment 2: End of Treatment Response|The percentage of the Virology Population subjects that were reported as undetectable HCV RNA at the completion of treatment.|Week 48 (Segment 1); Week 24 (Segment 2)|Segment 2 analyzed the Per Protocol Population, which includes all randomized subjects who completed 12 weeks of ACH-014625 dosing and an additional 12 weeks of Peg/Ribavirin dosing.||percentage of participants|||Number
824137|NCT01179516|Secondary|Change From Baseline in MADRS Total Score at Week 8 in Participants With Baseline Hamilton Anxiety Scale (HAM-A) Total Score ≥ 20|"The MADRS is a depression rating scale consisting of 10 items, each rated 0 (normal) to 6 (most abnormal). The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. LS means are from a mixed model for repeated measurements (MMRM) ANCOVA with treatment, center, week, treatment-by-week interaction, Baseline MADRS total score-by-week as fixed effects.
HAM-A is a 14 item rating scale to quantify anxiety severity rated on a 5-point scale from 0 (not present) to 4 (severe) with a total score range from 0 to 56, where lower scores indicate mild severity."|Baseline and Week 8|Full analysis set patients with a HAM-A Baseline score ≥ 20. A mixed model for repeated measurements (MMRM) based on observed cases was used.||scores on a scale||Standard Error|Least Squares Mean
824138|NCT01179516|Secondary|Mean Clinical Global Impression Scale - Improvement (CGI-I) Score at Week 8|The Clinical Global Impression - global improvement assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from a mixed model for repeated measurements (MMRM) ANCOVA with treatment, center, week, treatment-by-week interaction, Baseline Clinical Global Impression Scale-Severity of Illness (CGI-S) score-by-week as fixed effects.|Week 8|The Full Analysis Set. A mixed model for repeated measurements (MMRM) based on observed cases was used.||scores on a scale||Standard Error|Least Squares Mean
824139|NCT01179516|Secondary|Percentage of Participants With a MADRS Response at Week 8|Response is defined as a participant with a ≥50% decrease in Montgomery Åsberg Depression Rating Scale (MADRS) total score from Baseline. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.|Baseline and Week 8|Full analysis set, last observation carried forward was used.||percentage of participants|||Number
824140|NCT01179516|Primary|Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score|The MADRS is a depression rating scale consisting of 10 items, each rated 0 (normal) to 6 (most abnormal). The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. Least squares (LS) means are from a mixed model for repeated measurements (MMRM) analysis of covariance (ANCOVA) with treatment, center, week, treatment-by-week interaction, Baseline MADRS total score-by-week as fixed effects.|Baseline and Week 8|The full analysis set (FAS) included all randomized patients who received at least 1 dose of study drug, and had at least 1 valid post-baseline value for assessment of primary efficacy. A mixed model for repeated measurements (MMRM) based on observed cases was used.||scores on a scale||Standard Error|Least Squares Mean
824141|NCT01179568|Secondary|Change From Baseline in Work and Social Adjustment Scale (WSAS)|The WSAS is a modification of a scale introduced by Hafner and Marks (1976), consisting of 0-8 point ratings of the extent to which symptoms interfere with five areas of daily functioning: work, home management, private leisure, social leisure, and family relationships. It is a well-validated, widely used self-report measure. Additional time points include weeks 4, 8, 12, 16, and 40. A total score calculated as a sum of all items (possible range 0-40) was used in the analyses with higher scores indicating more impairment. For the pre-specified analyses we compared change in the WSAS total score from baseline (calculated as baseline score minus week 20 score) for CIT with CGT vs PLA with CGT (aim 2), and for CIT with CGT vs CIT (aim 3) based on the intention-to-treat principle including all randomized participants.|Baseline and week 20|Prespecified secondary analyses of self-report ratings of grief-related functional impairment (WSAS) compared changes in scores using a weighted linear regression with inverse probability weighting to adjust for missing assessments.||score change from baseline to wk20||Standard Deviation|Mean
824142|NCT01179568|Secondary|Change From Baseline in Work and Social Adjustment Scale (WSAS)|The WSAS is a modification of a scale introduced by Hafner and Marks (1976), consisting of 0-8 point ratings of the extent to which symptoms interfere with five areas of daily functioning: work, home management, private leisure, social leisure, and family relationships. It is a well-validated, widely used self-report measure. Additional time points include weeks 4, 8, 12, 16, and 40. A total score calculated as a sum of all items (possible range 0-40) was used in the analyses with higher scores indicating more impairment. For the pre-specified analyses we compared change in the WSAS total score from baseline (calculated as baseline score minus week 12 score) for CIT vs PLA at week 12 (aim 1), based on the intention-to-treat principle including all randomized participants.|Baseline and week 12|Prespecified secondary analyses of self-report ratings of grief-related functional impairment (WSAS) compared changes in scores using a weighted linear regression with inverse probability weighting to adjust for missing assessments.||score change from baseline to wk12||Standard Deviation|Mean
824143|NCT01179568|Secondary|Change From Baseline in Inventory of Complicated Grief (ICG)|The 19-item self-report instrument assesses symptoms of complicated grief. Responses on individual items are added up to a total score, which can range from 0 to 76 with higher scores indicating more intense symptoms. This scale has been utilized previously in treatment studies of CG. Additional times points include weeks 4, 8, 12, 16, 20 and 40. For the pre-specified analyses we compared change in the ICG total score from baseline (calculated as baseline score minus week 20 score) for CIT with CGT vs PLA with CGT (aim 2), and for CIT with CGT vs CIT (aim 3) based on the intention-to-treat principle including all randomized participants.|Baseline and week 20|Prespecified secondary analyses of self-report ratings of CG symptoms (ICG) compared changes in scores using a weighted linear regression with inverse probability weighting to adjust for missing assessments.||score change from baseline to wk20||Standard Deviation|Mean
824153|NCT01179672|Secondary|Mean Change From Baseline at 12-Week Endpoint in the BPI-Severity Scale|BPI-Severity Scale was a self-reported scale that measured the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). A negative change indicated an improvement in the participant's condition. LS mean was calculated using MMRM and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction.|Baseline, 12 weeks|ITT principle was applied: All participants with a baseline and 12-week, 24-hour BPI-Severity score based on the randomized group were analyzed.||units on a scale||Standard Error|Least Squares Mean
824144|NCT01179568|Secondary|Change From Baseline in Inventory of Complicated Grief (ICG)|The 19-item self-report instrument assesses symptoms of complicated grief. Responses on individual items are added up to a total score, which can range from 0 to 76 with higher scores indicating more intense symptoms. This scale has been utilized previously in treatment studies of CG. Additional times points include weeks 4, 8, 12, 16, 20 and 40. For the pre-specified analyses we compared change in the ICG total score from baseline (calculated as baseline score minus week 12 score) for CIT vs PLA at week 12 (aim 1), based on the intention-to-treat principle including all randomized participants.|Baseline and week 12|Prespecified secondary analyses of self-report ratings of CG symptoms (ICG) compared changes in scores using a weighted linear regression with inverse probability weighting to adjust for missing assessments.||score change from baseline to wk12||Standard Deviation|Mean
824145|NCT01179568|Primary|Responder Status Based on Complicated Grief Clinical Global Impression-Improvement (CGI-I) Scale|Brief rating scale frequently used in clinical trials. For this study, version modified for complicated grief was be used. Response is defined as a score of 1(very much improved) or 2 (much improved) on the scale. The rating was done by an Independent Evaluator.|Weeks 12 and 20|Response rates were compared under the intention-to-treat principle, including all randomized participants in a logistic regression with inverse probability weighting .||percentage of responders|||Number
824146|NCT01179672|Secondary|Mean Change From Baseline at 12 Week Endpoint in the SDS Total Score|SDS was self-reported and used to assess the effect of the participant's symptoms on their work (Item 1), social life (Item 2), and family life (Item 3). Each item was measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. SDS total score was the sum of the 3 items and ranged from 0 to 30, with higher values indicating greater disruption in the participant's work/social/family life. Scores ≥5 were associated with significant functional impairment. A negative change indicated an improvement in the participant's condition. LS mean was adjusted using MMRM and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, baseline score and baseline score-by-visit interaction.|Baseline, 12 weeks|All participants with non-missing SDS Total Score at baseline and 12 weeks.||units on a scale||Standard Error|Least Squares Mean
824147|NCT01179672|Secondary|Mean Change From Baseline at 12-week Endpoint in the BPI Interference Score|BPI-Interference Score was a self-reported scale that measured the interference of pain based on the average of the 7 questions assessing the interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The average interference scores ranged from 0 (does not interfere) to 10 (completely interferes). A negative change indicates an improvement in the participant's condition. LS means was calculated using MMRM and adjusted treatment, pooled investigator, visit, and treatment-by-visit interaction, baseline score and baseline score-by-visit interaction.|Baseline, 12 weeks|All participants with non-missing BPI-Interference score at baseline and 12 weeks.||units on a scale||Standard Error|Least Squares Mean
824148|NCT01179672|Secondary|Percentage of Participants Who Experienced Equal to or Greater Than 30%, 50% or 75% Reduction From Baseline at 12-week Endpoint in BPI-Severity Average Pain Score|BPI-Severity scale was a self-reported scale that measured the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). A negative change indicated an improvement in the participant's condition. Percentage of participants was calculated as: (number of participants with 30% [or 50% or 75%] reduction in BPI-Severity average pain) divided by (number of participants) multiplied by 100.|Baseline, 12 weeks|All participants with a baseline and postbaseline BPI-Severity average pain scores.||percentage of participants|||Number
824149|NCT01179672|Secondary|Percentage of Participants Who Experience Equal to or Greater Than 30%, 50% or 75% Reduction From Baseline at 12-Week Endpoint in Weekly Mean of Average Daily Pain|24-hour self-assessment of average daily pain was recorded in the participants diary based on an 11 point Likert scale with scores ranging from 0 (no pain) to 10 (worst possible pain). Percentage of participants was calculated as: (number of participants with 30% [or 50% or 75%] reduction in average daily pain) divided by (number of participants) multiplied by 100.|Baseline, 12 weeks|All participants with a baseline and postbaseline 24-hour average pain score.||percentage of participants|||Number
824150|NCT01179672|Secondary|Mean Change From Baseline at 12-Week Endpoint in the Sensory Subscale of the SF-MPQ|SF-MPQ was a self-reported instrument that consisted of 11 sensory descriptors describing pain. The descriptors were rated on an intensity scale from 0 (none), 1 (mild), 2 (moderate) or 3 (severe). Three (3) pain scores were derived from the sum of the intensity rank values of the words chosen for sensory descriptors. The SF-MPQ sensory subscale was the sum of the 11 scores (ranged from 0 to 33, with 33 being the worst pain). A negative change indicates an improvement. LS mean was calculated using analysis of covariance (ANCOVA) adjusted for treatment, pooled investigator and baseline.|Baseline, 12 weeks|ITT principle was applied: All participants with a baseline and 12 weeks SF-MPQ score based on the randomized group were analyzed; last observation carried forward (LOCF).||units on a scale||Standard Error|Least Squares Mean
824151|NCT01179672|Secondary|Patient Global Impression of Improvement (PGI-I) Scale at 12-Week Endpoint|PGI-I was self-reported and measured a participant's perception of improvement at the time of assessment compared with the start of treatment. Scores ranged from 1 (very much better) to 7 (very much worse). LS mean was calculated using MMRM and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction.|12 weeks|All participants with a baseline and 12-week PGI-I score.||units on a scale||Standard Error|Least Squares Mean
824152|NCT01179672|Secondary|Mean Change From Baseline at 12-Week Endpoint in the CGI-S Scale|CGI-S was administered by the investigator in the presence of the participant and measured the severity of illness at the time of assessment compared with start of treatment; CGI-S scores ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). A negative change indicated an improvement in the participant's condition. LS mean was calculated using MMRM and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction.|Baseline, 12 weeks|ITT principle was applied: All participants with a baseline and 12-week CGI-S score based on the randomized group were analyzed. Data from 9 sites was not included in analysis due to wrong questionnaire used.||units on a scale||Standard Error|Least Squares Mean
827181|NCT01202253|Secondary|Percentage of Participants With Prior Colonization With Candida by Colonization Index||Baseline|Data for prior colonization by colonization index was not analyzed as the study was retrospective and colonization index was not recorded for the participants.|||||
824154|NCT01179672|Secondary|Mean Change From Baseline at 12-Week Endpoint in Weekly Mean of Night Pain and Worst Pain|24-hour average night pain and worst pain severity scores were recorded daily on an 11-point Likert scale, an ordinal scale, with scores ranging from 0 (no pain) to 10 (worst possible pain). A negative change indicated an improvement in the participant's condition. LS mean was calculated using MMRM and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as the baseline score and baseline score-by-visit interaction.|Baseline, 12 weeks|ITT principle was applied: All participants with a baseline and 12-week 24-hour night pain score and worst pain score based on the randomized group were analyzed.||units on a scale||Standard Error|Least Squares Mean
824155|NCT01179672|Primary|Mean Change From Baseline at 12-Week Endpoint in the Weekly Mean of Pain Severity Score|24-hour average pain severity scores were recorded daily by the participant on an 11-point Likert scale, an ordinal scale, with scores ranging from 0 (no pain) to 10 (worst possible pain). The weekly mean was calculated. A negative change indicated an improvement in participant's condition. Least squares (LS) mean was calculated using mixed model repeating measures (MMRM) and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction.|Baseline, 12 weeks|Intent-to-treat (ITT) principle was applied: All participants with a baseline and 12-week 24-hour average pain score based on the randomized group were analyzed.||units on a scale||Standard Error|Least Squares Mean
824156|NCT01179737|Secondary|Total Number of Adverse Events and Serious Adverse Events|Adverse events were summarized by the number of patients having any adverse event overall and presented in the safety section. Study was prematurely terminated.|168 days||||||
824157|NCT01179737|Primary|Change in Pulmonary Vascular Resistance (PVR)|Change in pulmonary vascular resistance is measured via right heart catheter assessment according to local hospital procedures. It assesses several prognostic hemodynamic variables in pulmonary hypertension, including Pulmonary Vascular Resistance (PVR). Study was prematurely terminated and not powered for efficacy.|168 days||||||
824158|NCT01179737|Secondary|Change in Six-Minute Walk Distance (6MWD) From Baseline|During standardized walk course participants are connected to a portable pulse oximeter via a finger probe and instructed to walk at a comfortable speed for as far as they could manage in 6 minutes. Study was prematurely terminated and efficacy data were not analyzed or summarized|Baseline, 168 days||||||
824159|NCT01179919|Secondary|Steady-State Cmax and Cmin of Oseltamivir Carboxylate|Cmax is the maximum concentration and Cmin in the minimum concentration of oseltamivir carboxylate measured in nanogram of oseltamivir carboxylate per milliliter of plasma (ng/mL)|6 days|Subjects who received all 9 doses of oseltamivir||ng/mL||Standard Deviation|Mean
824160|NCT01179919|Primary|Steady-State AUC of Oseltamivir Carboxylate|AUC is the area under the concentration-time curve. This is measured as concentration in nanograms of oseltamivir carboxylate per milliliter of plasma multiplied by time in hours (hour*ng/mL)|6 days|Subjects who received all 9 doses of oseltamivir||hour*ng/mL||Standard Deviation|Mean
824161|NCT01179984|Secondary|Primary Target Lesion Patency|Percentage of participants with Primary Target Lesion Patency (TLP) at 12 months post-index procedure|12 months post-index procedure|Primary Target Lesion Patency (TLP) at 12 months post-index procedure.||percentage of participants|||Number
824162|NCT01179984|Primary|(Safety) Freedom From Occurrence of Death, Amputation and TVR/TLR at 30-days Post-index Procedure.|"Safety:
Freedom from occurrence of death, amputation and TVR/TLR at 30-days post-index procedure."|30 day follow-up|Freedom from occurrence of death, amputation and TVR/TLR at 30-days post-index procedure.||percentage of freedom from events|||Number
824163|NCT01179984|Primary|Acute Effectiveness: Percentage of Stents With Successful Delivery|"Effectiveness:
Acute effectiveness defined as the successful delivery of the stent with the post-deployment stent length being within 10% of the pre-deployment length."|At implantation (Day 0)|||percentage of stents|Stents|95% Confidence Interval|Mean
824193|NCT01180400|Secondary|Change in MADRS Total Score From Randomization (Week 8) to Week 10|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to Week 10|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
824172|NCT01180127|Secondary|VO2max|measured at randomization, i.e., before exposure to the intervention, and then again after completion of the 12-week intervention|Up to 12 weeks after exercise/dietary intervention exposure|One subject in the exercise, dietary intervention and one subject in the exercise, food additive lacking flavanol group had unusable data for this outcome and thus are not included in these analyses.||mL/(kg·min)||Standard Deviation|Mean
824173|NCT01180127|Secondary|Modified Rey Auditory Verbal Learning Test|Participants are read a list of words over three learning trials and the subject is asked to free recall as many words as possible after each trial. These 3 trials are followed by 1 learning trial of a distracter list and then a short delayed free recall trial of the initial list. After approximately 60-minutes, subjects are asked to freely recall words from the initial list, then to recall words form the distracter list, and then complete a forced-choice recognition trial. A source memory trial is administered in which subjects are read each presented word and then asked to identify whether they were initially presented during the 3 learning trials or during the distracter trial. Measured as a retention score (ratio) for which the number of words recalled after the short delay is divided by the number of words recalled on the third learning trial.|Up to 12 weeks after exercise/dietary intervention exposure|There were 4 subjects (1 in exercise, dietary intervention; 2 in no exercise, dietary intervention, and 1 in exercise, food additive lacking flavanol) who did not have useable data and are thus not included in analyses.||ratio||Standard Deviation|Mean
824174|NCT01180127|Primary|ModBent (Modified Benton Visual Retention Test)|This is an object recognition task. Participants view a complex stimulus, then are asked to select which one of two objects was identical to the studied stimulus. After a series of these matching trials, during the subsequent recognition trials participants are shown serially individual complex objects and asked to indicate whether the object was identical to any of the target stimuli viewed during the matching trials. Their reaction time for correct responses, measured in milliseconds, is the unit of measurement.|Up to 12 weeks after exercise/dietary intervention exposure|One subject in the exercise, dietary intervention and one subject in the no exercise, dietary intervention group had outlying (larger than 3 standard deviation from mean) ModBent values that were deleted and hence those groups have 7 and 10 subjects analyzed rather than 8 and 11 respectively.||milliseconds||Standard Deviation|Mean
824175|NCT01180127|Primary|CBV-fMRI (Cerebral Blood Volume-functional Magnetic Resonance Imaging)|In steady state conditions, CBV is an indirect measure of basal metabolism in the brain. CBV-fMRI is a technique that generates maps of basal metabolism across different brain regions|Up to 12 weeks after exercise/dietary intervention exposure|One subject in the exercise, food additive lacking flavanol arm, and one subject in the wait list control food additive without flavanol arm had non useable data for this outcome which is why there are only 8 subjects analyzed in those two arms rather than 9.||percent CBV in a brain region||Standard Deviation|Mean
824176|NCT01180244|Secondary|Change in Fibromyalgia Impact Questionnaire Sleep Satisfaction Visual Analog Scale|The Fibromyalgia Impact Questionnaire includes a sleep visual analog scale (VAS) with ranges of 0-10 centimeters. Higher values represent greater difficulty with sleep. The change in Fibromyalgia Impact Questionnaire sleep visual analog scale is determined by subtracting baseline VAS values from end of treatment VAS values. Thus, a negative value represents sleep improvement (i.e. a better outcome), while a positive value represents sleep worsening (i.e. a worse outcome).|Total timeframe 13 weeks: baseline followed by 11 weeks of treatment with outcome assessed within 14 days following end of treatment|Participants who correctly completed the outcome questionnaire||units on a scale||Standard Deviation|Mean
824177|NCT01180244|Secondary|Change in Fibromyalgia Impact Questionnaire Pain Visual Analog Scale|The Fibromyalgia Impact Questionnaire includes a pain visual analog scale (VAS) with ranges of 0-10 centimeters. Higher values represent greater pain. The change in Fibromyalgia Impact Questionnaire pain visual analog scale is determined by subtracting baseline VAS values from end of treatment VAS values. Thus, a negative value represents pain improvement (i.e. a better outcome), while a positive value represents pain worsening (i.e. a worse outcome).|Total timeframe 13 weeks: baseline followed by 11 weeks of treatment with outcome assessed within 14 days following end of treatment|Participants who correctly completed the outcome questionniare||units on a scale||Standard Deviation|Mean
824178|NCT01180244|Secondary|Change in Fibromyalgia Impact Questionnaire Overall Score|The Fibromyalgia Impact Questionnaire yields a score ranging from 0 to 100, with higher scores representing a greater impact or level of symptoms. The change in Fibromyalgia Impact Questionnaire is determined by subtracting scores at baseline from scores at end of treatment. Thus negative numbers represent symptom improvement (i.e. a better outcome) and positive numbers represent symptom worsening (i.e. a worse outcome).|Total timeframe 13 weeks: baseline followed by 11 weeks of treatment with outcome assessed within 14 days following end of treatment|Participants who correctly completed the outcome questionniare||units on a scale||Standard Deviation|Mean
824179|NCT01180244|Secondary|Change in Number of Positive Tender Points|"The number of positive tender points ranges from 0-18, and are defined per criteria set forth by the American College of Rheumatology and based on dolorimetry measurements made on 18 prescribed tender point locations. A tender point is considered positive if less than 4 kilograms per centimeter squared pressure is required to elicit a painful response. The change in number of positive tender points is determined by subtracting the number of positive tender points at baseline from the number of positive tender points at end of treatment. Thus, a negative number represents pain improvement (i.e. better outcome), whereas a positive number represents a worsening of pain (i.e. worse outcome)."|Total timeframe 13 weeks: baseline followed by 11 weeks of treatment with outcome assessed within 14 days following end of treatment|||Number of positive tender points||Standard Deviation|Mean
824180|NCT01180244|Primary|Change in Tender Point Pain Threshold|"Tender point pain threshold is derived by summing the dolorimetry-based pain pressure thresholds measured on a subject for each of the 18 tender points sites specified by the American College of Rheumatology for fibromyalgia classification. The range of dolorimeter values for each tender point site is 0-4 (units are kilograms per square centimeter, i.e. kg/cm^2). Higher numbers represent greater pressure required to elicit pain, and are thus indicators of less pain sensitivity at the tender point. Since 18 tender points are measured on a patient and their individual dolorimeter values summed, the range of tender point pain threshold values is 0-72. A higher score represents less overall pain sensitivity. The change in tender point pain threshold is determined by subtracting values at baseline from values at end of treatment. Thus a positive difference represents pain improvement (i.e.. a better outcome). A negative difference represents pain worsening (i.e. a worse outcome)."|Total timeframe 13 weeks: baseline followed by 11 weeks of treatment with outcome assessed within 14 days following end of treatment|||units on a scale||Standard Deviation|Mean
824181|NCT01180296|Secondary|Serum Progesterone Levels||At approximately 28 weeks' gestation||||||
824182|NCT01180296|Primary|Rate of Recurrent Preterm Birth|Spontaneous preterm birth prior to 37 weeks' gestation. Indicated preterm deliveries (for maternal or fetal reasons) were excluded.|Prior to 37 weeks' gestation|||participants|||Number
824183|NCT01180400|Secondary|Change in EuroQol - 5 Dimensions (EQ-5D) From Randomization (Week 8) to End of Treatment (Week 16)|A self-assessment questionnaire that provides 2 measures of health status. The EQ-5D index score is a weighted linear combination over 5 dimensions of health status. The score for each of the 5 dimensions can range from 1 to 3, and an equation is used to calculate the EQ-5D index score. The EQ-5D index score can range from possible negative values (minimum -0.415) to a maximum of 1.0. The EQ-VAS is a visual analog scale with a range of 0 to 100. For both variables, a higher score indicates a better health state.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
824184|NCT01180400|Secondary|Change From Randomization (Week 8) to End of Treatment (Week 16) in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q LES-Q-SF) Item 16|The Q-LES-Q-SF (Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form) measures the patient’s satisfaction with medication and overall quality of life. The 16th item is a global rating of overall life satisfaction and contentment, rated on a 1 to 5 scale. Higher scores are indicative of greater satisfaction.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
824185|NCT01180400|Secondary|Change From Randomization (Week 8) to End of Treatment (Week 16) in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q LES-Q-SF) Item 15|The Q-LES-Q-SF (Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form) measures the patient’s satisfaction with medication and overall quality of life. The 15th item queries respondents’ satisfaction with the medication they are taking, rated on a 1 to 4 scale, score 0 indicates that no medication was taken. Higher scores are indicative of greater satisfaction.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
824186|NCT01180400|Secondary|Change in Overall Quality of Life and Satisfaction From Randomization (Week 8) to End of Treatment (Week 16) by Assessing the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) % Maximum Total Score|The Q-LES-Q-SF (Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form)total score is derived by summing item scores 1 to 14. Higher scores are indicative of greater enjoyment or satisfaction in each domain. The Q-LES-Q-SF % maximum total score is calculated as 100% × (Q-LES-Q-SF total score – 14) / 56, and can range from 0% to 100%.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
824187|NCT01180400|Secondary|Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Family Life/Home Responsibilities Domain Score|A 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The 3 inter-correlated domains are school/work, social life, and family life/home responsibilities. The numerical rating for the SDS family life/home responsibilities domain score is 0- 10, where 10 is considered to be 'highly impaired'.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
824188|NCT01180400|Secondary|Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Social Life Domain Score|A 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The 3 inter-correlated domains are school/work, social life, and family life/home responsibilities. The numerical rating for the SDS social life domain score is 0- 10, where 10 is considered to be 'highly impaired'.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
824189|NCT01180400|Secondary|Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Work/School Domain Score|A 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The 3 inter-correlated domains are school/work, social life, and family life/home responsibilities. The numerical rating for the work/school domain score is 0- 10, where 10 is considered to be 'highly impaired'.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
824190|NCT01180400|Secondary|Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by the Sheehan Disability Scale (SDS) Total Score|Sheehan Disability Scale (SDS) is 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The SDS total score is calculated as the sum of the score for the 3 inter-correlated domains (school/work, social life, and family life/home responsibilities) and ranges from 0 (unimpaired) to 30 (highly impaired).|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
824191|NCT01180400|Secondary|Change in MADRS Total Score From Randomization (Week 8) to Week 14|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to Week 14|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
824192|NCT01180400|Secondary|Change in MADRS Total Score From Randomization (Week 8) to Week 12|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to Week 12|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
824194|NCT01180400|Secondary|Change in MADRS Total Score From Randomization (Week 8) to Week 9|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to Week 9|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
824195|NCT01180400|Secondary|Response in the Clinical Global Impression-Improvement (CGI-I) Defined as CGI-I Rating of “Very Much Improved” or “Much Improved” From Randomization (Week 8) to End of Treatment (Week 16)|A 3-part, clinician-administered scale that rates the improvement or worsening of the patient’s illness from randomization (baseline). Each item is scored on a 1 to 7 scale. CGI-I scores >4 indicate worsening, while scores <4 indicate improvement.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||percentage of participants analyzed|||Number
824196|NCT01180400|Secondary|Change in the Clinician-rated Global Outcome of Severity as Measured by the Clinical Global Impression-Severity (CGI-S) Score From Randomization (Week 8) to End of Treatment (Week 16)|A 3-part, clinician-administered scale that rates the improvement or worsening of the patient’s illness from randomization (baseline). Each item is scored on a 1 to 7 scale. Higher CGI-S scores indicate greater illness severity.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
824197|NCT01180400|Secondary|Change in Depressive Symptoms From Randomization (Week 8) to End of Treatment (Week 16) as Measured by Hamilton Rating Scale for Depression-17 Items (HAMD-17) Total Score|A 17-item, clinician-rated scale that assesses depressive symptoms. The HAMD-17 consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The HAMD-17 total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher HAMD-17 scores indicate more severe depression.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
824198|NCT01180400|Secondary|Sustained Remission, Defined as a MADRS Total Score of ≤8 at Week 12, Week 14, and End of Treatment (Week 16)|"The percentage of patients with a MADRS total score of ≤8 at Week 12, Week 14, and end of treatment (Week 16)was calculated.
A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Week 12, Week 14, Week 16|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||percentage of participants analyzed|||Number
824199|NCT01180400|Secondary|Sustained Response, Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score and a MADRS Total Score of ≤12 at Week 12, Week 14, and End of Treatment (Week 16)|"The percentage of patients with a ≥50% reduction from randomization (Week 8) in MADRS total score and a MADRS total score of ≤12 at Week 12, Week 14, and end of treatment (Week 16) was calculated.
A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Randomization (Week 8) to end of treatment (Week 16); Week 12, Week 14, and Week 16|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||percentage of patients analyzed|||Number
824200|NCT01180400|Secondary|Early and Sustained Response, Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score and a MADRS Total Score of ≤12 at Week 10, Week 12, Week 14, and End of Treatment (Week 16)|"The percentage of patients with a ≥50% reduction from randomization (Week 8) in MADRS total score and a MADRS total score of ≤12 at Week 10, Week 12, Week 14, and end of treatment (Week 16) was calculated.
A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Randomization (Week 8) to end of treatment (Week 16); Week 10, Week 12, Week 14, and Week 16|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||percentage of participants analyzed|||Number
824201|NCT01180400|Secondary|Remission in Depressive Symptoms of MDD, Defined as MADRS Total Score of ≤8 at End of Treatment (Week 16)|"The percentage of patients with a MADRS total score of ≤8 at end of treatment (Week 16) was calculated.
A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Week 16|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||percentage of participants analyzed|||Number
824218|NCT01180790|Secondary|Segment 1 and Segment 2: Sustained Virologic Response 12 Weeks ( Three Months Post Dosing) (SVR12)|The percentage of the Virology Population subjects that achieved sustained virologic response, defined as HCV RNA < LOQ, at 12 weeks (three months) post dosing.|3 months post dosing|Segment 2 analyzed the Per Protocol Population (PPP=all randomized subjects completing 12 wks of ACH-014625 + an extra 12 wks of Peg/RBV) who returned for SVR12.||percentage of participants|||Number
824202|NCT01180400|Secondary|Response in Depressive Symptoms of Major Depressive Disorder (MDD), Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score at End of Treatment (Week 16)|"The percentage of patients with a ≥50% reduction from randomization (Week 8) in MADRS total score at end of treatment (Week 16) was calculated.
A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||percentage of participants analyzed|||Number
824203|NCT01180400|Primary|Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Randomization to End of Treatment.|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
824204|NCT01180647|Secondary|Adverse Events and Serious Adverse Events|AEs and SAEs per standard definitions will be measured by self-report.|Eight weeks post-release|One XR-NTX participant who was randomized was excluded from final data analysis because he was never released from jail to community.||participants|||Number
824205|NCT01180647|Secondary|Accidental Drug Overdose|Accidental drug overdose is defined as patient self-report of any event consistent with over-sedation or respiratory suppression following ingestion of alcohol, prescription, or illicit drugs.|Four weeks post-release|One XR-NTX participant who was randomized was excluded from final data analysis because he was never released from jail to community.||participants|||Number
824206|NCT01180647|Secondary|Injection Drug Use Post-release|This secondary outcome tracks any injection drug use and frequency of injection drug use in the four weeks following release from jail.|Four weeks post-release|||percentage of participants by arm|||Number
824207|NCT01180647|Secondary|Any Opioid Use Post-release|Counts of any opioid use, defined as self-reported ≥ 1 day of heroin or other opioid use as measured by the Timeline Follow-Back assessment during the first 4 weeks post-release.|Four weeks post-release|One XR-NTX participant who was randomized was excluded from final data analysis because he was never released from jail to community.||percentage of participants|||Number
824208|NCT01180647|Secondary|Participation in Community Drug Treatment Post-release|This secondary outcome tracks community drug treatment initiation four weeks post-release from jail. Measured by self-report community drug treatment initiation at week 4 study visit.|Four weeks post-release|One XR-NTX participant who was randomized was excluded from final data analysis because he was never released from jail to community.||percentage of participants|||Number
824209|NCT01180647|Primary|Post-Release Opioid Relapse|Post-release opioid relapse at week 4, measured by self-report (Time Line Follow Back) and urine toxicologies, and defined as ≥10 of 28 days of self-reported opioid misuse following jail release or two or three positive of the three urine samples during weeks 2, 3 and 4. A single positive or missing urine result counted as 7 opioid misuse days.|Four weeks post-release|One XR-NTX participant randomized was excluded from final data analysis due to the fact he was never released from jail to community, so primary outcome (post-release opioid relapse) could not be measured.||participants||95% Confidence Interval|Number
824210|NCT01180660|Secondary|24 Hour Total Opioid Consumption|24 hour total opioid consumption using IV morphine equivalents|24 hours post surgery|||miligrams||Inter-Quartile Range|Median
824211|NCT01180660|Primary|Quality of Recovery 40 on the Day After Surgery|"Quality of Recovery 40 on the Day After Surgery. The survey is a quality of recovery tool and a score of 40 is low and 200 is high.
The minimum score is 40 which is minimum recovery score and them maximum score is 200 which is considered better recovery."|24 hours|||units on scale 40 (low) - 200 (high)||Inter-Quartile Range|Median
824212|NCT01180777|Secondary|Corneal Staining|Corneal staining type was graded in a 5-point scale over the 5 corneal regions by Investigator using a slit lamp; 0=none, 1=trace, 2=mild, 3=moderate, and 4=severe. Maximum grade of corneal staining type over the 5 corneal regions was categorized either absence or presence of corneal staining for the analysis.|After 6-9 days of lens wear|All subjects who successfully completed the study.||eyes|eye||Number
824213|NCT01180777|Secondary|Binocular Snellen Visual Acuity (VA)|Binocular Snellen VA was assessed at dispensing by Investigator using a Snellen vision chart. Subjects were analyzed based on their performance on a Snellen Vision chart exam in the study lenses in an effort to measure how well the lenses perform for vision correction.|10-15 minutes post lens fit|All subjects who successfully completed the study.||participants|||Number
824214|NCT01180777|Primary|Lens Fit Acceptance|Lens fit acceptance (whether acceptable or unacceptable) was assessed by the Investigator at dispensing.|10-15 minutes post lens fit|All subjects who successfully completed the study.||eyes|Eyes||Number
824215|NCT01180790|Secondary|Segment 1 and Segment 2: HCV RNA Change From Baseline|Change from baseline in log10 HCV RNA level by visit.|Week 12|Efficacy analysis was performed on the virology population , which was a subset of the ITT population and included all subjects who had a baseline HCV RNA result and at least 1 post baseline HCV RNA result||log10 HCV RNA level||Standard Deviation|Mean
824216|NCT01180790|Secondary|Segment 1 and Segment 2: HCV RNA Change From Baseline|The mean change from baseline in log10 HCV RNA level by visit for the virology population|Week 4|Efficacy analysis was performed on the virology population, which was a subset of the ITT population and included all subjects who had a baseline HCV RNA result and at least 1 post baseline HCV RNA result||log10 HCV RNA Level||Standard Deviation|Mean
824217|NCT01180790|Secondary|Segment 1 and Segment 2: Sustained Virologic Response ( Six Months Post Dosing) (SVR24)|The percentage of the Virology Population subjects that achieved sustained virologic response, defined as HCV RNA < LOQ, six months post dosing.|6 months post dosing|Segment 2 analyzed the Per Protocol Population (PPP=all randomized subjects completing 12 wks of ACH-014625 + an extra 12 wks of Peg/RBV) who returned for SVR24.||percentage of participants|||Number
824220|NCT01180790|Secondary|Segment 2: RVR4 (Rapid Viral Response at 4 Weeks)|For Segment 2, the percentage of subjects in the virology population that achieved RVR4, defined as HCV RNA< or equal to LOQ at the Week 4 visit.|4 weeks|Per protocol virology population (a subset of the virology population) and included all randomized subjects who completed 4 weeks of ACH-0141625 dosing.||percentage of participants|||Number
824221|NCT01180790|Secondary|Segment 1: Complete Early Virologic Response (cEVR)|For Segment 1, the percentage of subjects in the virology population that achieved cEVR (complete early virologic response), defined as undetectable HCV RNA at Week 12.|12 weeks|Analysis for Segment 1 was performed on the virology population (which is the same as the ITT population) and included all subjects who had a baseline HCV RNA result and at least 1 post baseline HCV RNA result.||percentage of participants|||Number
824222|NCT01180790|Primary|Segment 2: Complete Early Virologic Response (cEVR)|The primary efficacy endpoint for Segment 2 of the study was the percentage of subjects achieving cEVR (complete early virologic response), defined as undetectable HCV RNA at Week 12.|Week 12|Per protocol virology population (a subset of the virology population) and included all randomized subjects who completed 12 weeks of ACH-0141625 dosing.||percentage of participants|||Number
824223|NCT01180790|Primary|Segment 2: Safety|Segment 2: Percentage of Subjects with the following: adverse events, abnormal laboratory safety tests and dose reductions, interruptions and discontinuations. Criteria for abnormal laboratory safety tests: treatment-emergent worsening DAIDs graded laboratory tests.|12 weeks|The safety population, which was defined as all subjects randomized and treated with at least one dose of ACH-0141625. Subjects were analyzed according to the randomized treatment.||percentage of participants|||Number
824224|NCT01180790|Primary|Segment 1 : Rapid Viral Response at Week 4 (RVR4)|The primary efficacy endpoint for Segment 1 of the study was the percentage of subjects in each treatment group achieving RVR at Week 4 (HCV RNA< or equal to LOQ at the Week 4 visit).|4 weeks|Efficacy analysis was performed on the virology population (a subset of the ITT population) and included all subjects who had a baseline HCV RNA result and at least 1 post baseline HCV RNA result.||percentage of participants|||Number
824225|NCT01180790|Primary|Segment 1: Safety|Segment 1: Percentage of subjects with the following: adverse events, abnormal laboratory safety tests, dose reductions, interruptions, and discontinuations. Criteria for abnormal laboratory safety tests: treatment-emergent worsening DAIDs graded laboratory tests.|4 weeks|The safety population, which was defined as all subjects randomized and treated with at least one dose of ACH-0141625 or Placebo. Subjects were analyzed according to the randomized treatment.||percentage of participants|||Number
824226|NCT01180894|Secondary|The Number of Participants Who Died||28 Days|||participants|||Number
824227|NCT01180894|Secondary|Infection|"The number of participants with at least one infection.
Specific infections analyzed included VAP (Ventilator-Associated Pneumonia), bacteremia, and urinary tract infection (UTI)."|28 Days|||participants|||Number
824228|NCT01180894|Secondary|Iron-deficient Erythropoeisis (IDE)|An elevated eZPP is diagnostic of Iron-deficient erythropoiesis (IDE) and reflects the bone marrow iron supply regardless of total body iron.|14 Days|||micro mol: mol heme||Full Range|Mean
824229|NCT01180894|Primary|RBC Transfusion|The number of participants who underwent RBC transfusion.|42 Days|||participants|||Number
824230|NCT01180985|Secondary|Subjective Assessment of Lens Comfort Using the Contact Lens User Experience (CLUE)TM Questionnaire.|Contact Lens User Experience CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.|10 minutes after lens insertion at time of initial lens fitting|Analysis is on those subjects who were enrolled, randomized to a study arm, and completed the study.||CLUE score||Standard Deviation|Mean
824231|NCT01180985|Secondary|Bulbar Redness|Scale of 0 to 4, where 0=None, 2=Trace, 3=Mild, 4=Moderate, 5=Severe.|after 7 days of lens wear|Analysis is on those subjects who were enrolled, randomized to a study arm, and completed the study.||eyes|eyes||Number
824232|NCT01180985|Primary|Subjective Assessment of Quality of Vision Using the Contact Lens User Experience(CLUE)TM Questionnaire.|Contact Lens User Experience CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.|after 7 +/- 1 days of lens wear|Analysis is on those subjects who were enrolled, randomized to a study arm, and completed the study.||CLUE score||Standard Error|Least Squares Mean
824233|NCT01180985|Secondary|Limbal Redness|Scale of 0 to 4, where 0=None, 2=Trace, 3=Mild, 4=Moderate, 5=Severe.|after 7 days of lens wear|Analysis is on those subjects who were enrolled, randomized to a study arm, and completed the study.||eyes|eyes||Number
824234|NCT01180985|Primary|Subjective Assessment of Lens Comfort Using the Contact Lens User Experience (CLUE)TM Questionnaire.|The contract Lens Experience (CLUE)TM questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.|after 7 +/-1 days of lens wear|Analysis is on those subjects who were enrolled, randomized to a study arm, and completed the study.||CLUE score||Standard Error|Least Squares Mean
824235|NCT01180985|Primary|Visual Acuity Binocular|Snellen binocular visual acuity measurement|after 7 +/- 1 days of lens wear|Analysis is on those subjects who were enrolled, randomized to a study arm, and completed the study.||participants|||Number
824236|NCT01180985|Primary|Visual Acuity Monocular|Snellen monocular visual acuity measurement was measured in both eyes that wore lenses for one week and came in for the evaluation with an inserted lens.|after 7 +/- 1 days of lens wear|Analysis is on those subjects who were enrolled, randomized to a study arm, and completed the study.||eyes|eyes||Number
824320|NCT01181271|Secondary|Cumulative Incidence of Non-relapse Mortality|Non-relapse mortality is defined as participants who die from causes other than their underlying disease relapse, such as infection or graft versus host disease|2-years after allogeneic transplant|||percentage of participants||90% Confidence Interval|Number
824237|NCT01180998|Primary|Distance Visual Acuity (VA)|Visual Acuity is measured monocularly (each eye separately) in Snellen, the converted to logMAR units. The logMAR scale has a range of -0.30 to 1.00. A value of 0 or less would not require distance vision correction and a value of 0 or greater may require distance vision correction.|after 4 weeks of toric contact lens wear|All subjects that were dispensed a study lens except those that discontinued for non-clinical reasons.||logMAR|eyes|Standard Error|Least Squares Mean
824238|NCT01180998|Primary|Distance Visual Acuity|Measured monocularly (each eye separately) in Snellen converted to logMAR units. The logMAR scale has a range of -0.30 to 1.00. A value of 0 or less would not require distance vision correction and a value of 0 or greater may require distance vision correction.|after 1 week of toric contact lens wear|All subjects that were dispensed a study lens except those that discontinued for non-clinical reasons.||logMAR|eyes|Standard Error|Least Squares Mean
824239|NCT01180998|Primary|Overall Success in Fitting With a Toric Contact Lens|Percent of subjects with success with toric lens fitting defined as meeting all of the following pre-determined criteria: 1) acceptable fit, 2) orientation stability less than or equal to 20 degree rotation, 3) binocular visual acuity (VA) within one line of spectacle VA, 4) Good, very good, or excellent overall quality of Vision, and 5) good, very, good, or excellent overall lens comfort. There was not an inferential statistical analysis conducted on this outcome. Comparison was made through the use of 95% CI's for the proportions. Therefore no statistical analysis section is included for this primary outcome.|4 weeks|All subjects that were dispensed a study lens except those that discontinued for non-clinical reasons.||percentage of participants||95% Confidence Interval|Number
824240|NCT01181011|Secondary|Number of Participants With Clinically Relevant Findings in Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities||4 weeks|Treated set||Participants|||Number
824241|NCT01181011|Secondary|Number of Participants With at Least One Treatment Emergent Adverse Event||4 weeks|Treated set||Participants|||Number
824242|NCT01181011|Secondary|V_z/F of Amlodipine||3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs|All patients with values for V_z/F of Amlodipine||L||Standard Deviation|Mean
824243|NCT01181011|Secondary|CL/F of Amlodipine||3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs|All patients with values for CL/F of Amlodipine||L/h||Standard Deviation|Mean
824244|NCT01181011|Secondary|t_½ of Amlodipine||3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs|All patients with values for t_½ of Amlodipine||h||Standard Deviation|Mean
824245|NCT01181011|Secondary|MRT_po of Amlodipine||3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs|All patients with values for MRT_po of Amlodipine||h||Standard Deviation|Mean
824246|NCT01181011|Secondary|λz of Amlodipine||3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs|All patients with values for λz of Amlodipine||1/h||Standard Deviation|Mean
824247|NCT01181011|Secondary|Tmax of Amlodipine||3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs|All patients with values for tmax of Amlodipine||h||Standard Deviation|Mean
824248|NCT01181011|Secondary|Apparent Volume of Distribution During the Terminal Phase λz Following an Extravascular Administration (V_z/F) of Telmisartan||3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs|All patients with values for V_z/F of Telmisartan||L||Standard Deviation|Mean
824249|NCT01181011|Secondary|Apparent Clearance of Telmisartan in Plasma Following Extravascular Administration (CL/F)||3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs|All patients with values for CL/F of Telmisartan||L/h||Standard Deviation|Mean
824250|NCT01181011|Secondary|Elimination Half-life (t_½) of Telmisartan||3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs|All patients with values for t_½ of Telmisartan||h||Standard Deviation|Mean
824251|NCT01181011|Secondary|Mean Residence Time of Telmisartan in the Body After Oral Administration (MRT_po)||3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs|All patients with values for MRT_po of Telmisartan||h||Standard Deviation|Mean
824252|NCT01181011|Secondary|Terminal Rate Constant in Plasma (λz) of Telmisartan|reflect the speed of drug elimination in vivo|3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs|All patients with values for λz of Telmisartan||1/h||Standard Deviation|Mean
824253|NCT01181011|Secondary|Time to Attain Cmax (Tmax) of Telmisartan||3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs|All patients with values for tmax of Telmisartan||h||Standard Deviation|Mean
824254|NCT01181011|Primary|Cmax of Amlodipine||3 periods of single-dose treatment (8 days of sampling) separated by 21 days of wash-outs|All patients with values for Cmax of Amlodipine||ng/mL||Geometric Coefficient of Variation|Geometric Mean
824255|NCT01181011|Primary|AUC_0-∞ of Amlodipine||3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs|All patients with values for AUC_0-∞ of Amlodipine||ng·h/mL||Geometric Coefficient of Variation|Geometric Mean
824256|NCT01181011|Primary|AUC_0-tz of Amlodipine||3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs|All patients with values for AUC_0-tz of Amlodipine||ng·h/mL||Geometric Coefficient of Variation|Geometric Mean
824257|NCT01181011|Primary|The Maximum Observed Plasma Concentration (Cmax) of Telmisartan||3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs|All patients with values for Cmax of Telmisartan||ng/mL||Geometric Coefficient of Variation|Geometric Mean
824258|NCT01181011|Primary|Area Under the Plasma Concentration-time Curve From the Time of Dosing to Infinity (AUC_0-∞) of Telmisartan||3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs|All patients with values for AUC_0-∞ of Telmisartan||ng·h/mL||Geometric Coefficient of Variation|Geometric Mean
824259|NCT01181011|Primary|Area Under the Concentration-time Curve of Telmisartan in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point (AUC_0-tz)||3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs|All patients with values for AUC_0-tz of Telmisartan||ng·h/mL||Geometric Coefficient of Variation|Geometric Mean
824321|NCT01181271|Secondary|Cumulative Incidence of Extensive Chronic Graft-versus-host-disease|Extensive chronic graft versus-host-disease (GVHD) was defined as GVHD that required systemic immunosuppression.|1-year after allogeneic transplant|||percentage of participants||90% Confidence Interval|Number
824260|NCT01181050|Secondary|Change in DAS28-CRP After 24 Weeks of Treatment.|DAS28-CRP=0.56×sqrt(tender joints [count:1-28])+0.28×sqrt(swollen joints [count:1-28])+0.36×Ln(CRP level+1)+0.014×(patient’s disease assessment on 0-100 mm scale [100=most severe])+0.96. Range: 0.96 to no upper limit. Higher score=more severe disease. Mean change in DAS-CRP score after 24 Weeks of treatment.|Week 0, Week 24|Change in DAS28-CRP was calculated by using last observation carried forward method.||scores||Standard Deviation|Mean
824261|NCT01181050|Secondary|Change in DAS28-CRP After 6 Weeks of Treatment.|DAS28-CRP=0.56×sqrt(tender joints [count:1-28])+0.28×sqrt(swollen joints [count:1-28])+0.36×Ln(CRP level+1)+0.014×(patient’s disease assessment on 0-100 mm scale [100=most severe])+0.96. Range: 0.96 to no upper limit. Higher score=more severe disease. Mean change in DAS-CRP score after 6 Weeks of treatment.|Week 0, Week 6|Change in DAS28-CRP was calculated by using last observation carried forward method.||scores||Standard Deviation|Mean
824262|NCT01181050|Primary|Change in DAS28-CRP After 12 Weeks of Treatment|DAS28-CRP=0.56×sqrt(tender joints [count:1-28])+0.28×sqrt(swollen joints [count:1-28])+0.36×Ln(CRP level+1)+0.014×(patient’s disease assessment on 0-100 mm scale [100=most severe])+0.96. Range: 0.96 to no upper limit. Higher score=more severe disease. Mean change in DAS-CRP score after 12 Weeks of treatment.|Week 0, Week 12|Change in DAS28-CRP was calculated by using last observation carried forward method.||scores||Standard Deviation|Mean
824263|NCT01181102|Secondary|Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding.||2 weeks|The Safety Analysis Set was defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment||percentage of subjects with bleeds||95% Confidence Interval|Number
824264|NCT01181102|Primary|Incidence of Subjects With Venous Thromboembolism Events.|"The primary efficacy endpoint was the proportion of subjects who experienced at least one of the thromboembolic events listed below during the period from the start of study treatment to the venography at the end of study treatment.
Lower extremity Deep Vein Thrombosis (DVT) confirmed by unilateral venography at the end of study treatment
Definite diagnosis of symptomatic Pulmonary Embolism (PE)
Symptomatic DVT confirmed before the venography at the end of study treatment The objectives were to verify the non-inferiority of edoxaban to enoxaparin with regard to prevention of venous Thromboembolism (VTE)"|2 weeks|Efficacy Analysis population. 22 (7.4%) - DU-176b 41 (13.9%) - enoxaparin||percent of participants with VTE events||95% Confidence Interval|Number
824265|NCT01181128|Secondary|Number of Transfusions Required Per Surgery|Number of blood component transfusions during a single surgery.|up to 52 weeks ± 2 weeks|Participants in the Full Analysis Set (FAS) who received at least 1 dose of rFVIIIFc and underwent major surgery.||surgeries|Major Surgeries||Number
824266|NCT01181128|Secondary|Estimated Total Blood Loss During Major Surgery||up to 52 weeks ± 2 weeks|Participants in the Full Analysis Set (FAS) who received at least 1 dose of rFVIIIFc, underwent major surgery, and had blood loss during surgery information available.||mL|Major Surgeries|Full Range|Median
824267|NCT01181128|Secondary|Dose Per Injection and Total Dose Required to Maintain Hemostasis During Major Surgery|Mean dose per injection is the average dose for all injections (including loading dose) needed to maintain hemostasis during surgery. Total dose is the sum across all injections (including loading dose) needed to maintain hemostasis during surgery.|up to 52 weeks ± 2 weeks|Participants in the Full Analysis Set (FAS) who received at least 1 dose of rFVIIIFc and underwent major surgery.||IU/kg|Major Surgeries|Full Range|Median
824268|NCT01181128|Secondary|Number of Injections Required to Maintain Hemostasis During Major Surgery|The number of injections to maintain hemostasis during surgery includes all injections for surgery purposes, including from the loading dose to the end date/time of surgery.|up to 52 weeks|Participants in the Full Analysis Set (FAS) who received at least 1 dose of rFVIIIFc and underwent major surgery.||injections|Major Surgeries|Full Range|Median
824269|NCT01181128|Secondary|Investigators’/Surgeons’ Assessment of Participants’ Response to rFVIIIFc for Major Surgery|Based on the first assessment of hemostasis by the surgeon/investigator 24 hours or later post-surgery. Scaled responses: Excellent = 1, Good = 2, Fair = 3, Poor/none = 4.|up to 52 weeks|Participants in the Full Analysis Set (FAS) who received at least 1 dose of rFVIIIFc and underwent major surgery.||responses|Major Surgeries||Number
824270|NCT01181128|Secondary|Hemophilia-Specific Quality of Life Index for Children (Haemo-QoL) Questionnaire: Change From Baseline to Week 14 and Week 28 in Haemo-QoL III Total Score|The Haemo-QoL III, a quality of life assessment instrument for adolescents with hemophilia, was administered to participants from 13 to 16 years old. This instrument assesses domains specific to living with hemophilia and consists of 12 domains: physical health, feeling, view of yourself, family, friends, others, sports and school, treatment, perceived support, dealing with hemophilia, future, and relationships. Total HAEMO-QoL score is the sum of all raw scores for all subscales for participants for whom at least the minimum number of required questions have been answered. Total scores are presented as the Transformed Scale Score (TSS) from 0-100%, with lower scores indicating a better quality of life. A negative change indicates improvement.|Baseline, Week 14, Week 28|Full Analysis Set: participants 13 to 16 years of age who received at least 1 dose of rFVIIIFc and had an assessment. n=participants who had specified assessment at given timepoint.||units on a scale||Full Range|Median
824271|NCT01181128|Secondary|Hemophilia-Specific Quality of Life Index for Adults (Haem-A-QoL) Questionnaire: Change From Baseline to Week 28|The Haem-A-QoL consists of items pertaining to 10 domains specific to living with hemophilia and was administered to adult participants (17 years and older). The 10 domains are: physical health, feeling, view of yourself, sports/leisure, school/work, dealing with hemophilia, and treatment (time frame for all 7 domains, during the last month) and future, family planning, and outlook for the future (time frame for all 3 domains, recently). Lower scores represent better QoL; therefore, a negative change from baseline represents improvement during the course of the study. Scores on a scale range between 0 and 100. Participants in Arm 1 were stratified by their prestudy regimen (either prophylaxis or on-demand).|Baseline, Week 28|Full Analysis Set: participants over 17 years of age who received at least 1 dose of rFVIIIFc and had an assessment. n=participants who had specified assessment at given timepoint.||units on a scale||Full Range|Median
824322|NCT01181271|Secondary|Cumulative Incidence of Grades II to IV Acute Graft Versus Host Disease (GVHD)|Grade I GVHD is characterized as mild disease, grade II GVHD as moderate, grade III as severe, and grade IV life-threatening.|within 200 days after allogeneic transplant|||percentage of participants||90% Confidence Interval|Number
824272|NCT01181128|Secondary|Hemophilia-Specific Quality of Life Index for Adults (Haem-A-QoL) Questionnaire: Change From Baseline to Week 14|The Haem-A-QoL consists of items pertaining to 10 domains specific to living with hemophilia and was administered to adult participants (17 years and older). The 10 domains are: physical health, feeling, view of yourself, sports/leisure, school/work, dealing with hemophilia, and treatment (time frame for all 7 domains, during the last month) and future, family planning, and outlook for the future (time frame for all 3 domains, recently). Lower scores represent better QoL; therefore, a negative change from baseline represents improvement during the course of the study. Scores on a scale range between 0 and 100. Participants in Arm 1 were stratified by their prestudy regimen (either prophylaxis or on-demand).|Baseline, Week 14|Full Analysis Set: participants over 17 years of age who received at least 1 dose of rFVIIIFc and had an assessment. n=participants who had specified assessment at given timepoint.||units on a scale||Full Range|Median
824273|NCT01181128|Secondary|Incremental Recovery (Two-stage Chromogenic Assay)|The rise in FVIII activity in IU/dL per unit dose administered in IU/kg. Sampling for Advate PK profiling was conducted, following at least 96 hours of washout, at these timepoints: preinjection and at either 30 (±3) minutes or 10 (±3) minutes, 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 48 (±2) hours (Day 2), and 72 (±2) hours (Day 3) from the start of the injection. Sampling for rFVIIIFc PK profiling was conducted at Day 0 (directly following at least 96 hours washout from Advate PK profiling or within 4 weeks of the Advate dose or other rFVIII product) and repeated 12 to 24 weeks later at the following timepoints: preinjection and at 30 (±3) minutes (or 10 (±3) minutes), 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 72 (±2) hours (Day 3), 96 (±2) hours (Day 4), and 120 (±2) hours (Day 5) from the start of the injection.|See Measure Description for complete time frame.|Participants who had evaluable two-stage PK profiles for both Advate and baseline rFVIIIFc.||IU/dL per IU/kg||95% Confidence Interval|Geometric Mean
824274|NCT01181128|Secondary|Mean Residence Time (MRT; Two-stage Chromogenic Assay)|The average time that a drug molecule is present in the systemic circulation. Sampling for Advate PK profiling was conducted, following at least 96 hours of washout, at these timepoints: preinjection and at either 30 (±3) minutes or 10 (±3) minutes, 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 48 (±2) hours (Day 2), and 72 (±2) hours (Day 3) from the start of the injection. Sampling for rFVIIIFc PK profiling was conducted at Day 0 (directly following at least 96 hours washout from Advate PK profiling or within 4 weeks of the Advate dose or other rFVIII product) and repeated 12 to 24 weeks later at the following timepoints: preinjection and at 30 (±3) minutes (or 10 (±3) minutes), 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 72 (±2) hours (Day 3), 96 (±2) hours (Day 4), and 120 (±2) hours (Day 5) from the start of the injection.|See Measure Description for complete time frame.|Participants who had evaluable two-stage PK profiles for both Advate and baseline rFVIIIFc.||hours||95% Confidence Interval|Geometric Mean
824275|NCT01181128|Secondary|Clearance (CL; Two-stage Chromogenic Assay)|Rate at which the body removes the drug, measured as the volume of the plasma cleared of drug per unit time per unit weight. Sampling for Advate PK profiling was conducted, following at least 96 hours of washout, at these timepoints: preinjection and at either 30 (±3) minutes or 10 (±3) minutes, 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 48 (±2) hours (Day 2), and 72 (±2) hours (Day 3) from the start of the injection. Sampling for rFVIIIFc PK profiling was conducted at Day 0 (directly following at least 96 hours washout from Advate PK profiling or within 4 weeks of the Advate dose or other rFVIII product) and repeated 12 to 24 weeks later at the following timepoints: preinjection and at 30 (±3) minutes (or 10 (±3) minutes), 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 72 (±2) hours (Day 3), 96 (±2) hours (Day 4), and 120 (±2) hours (Day 5) from the start of the injection.|See Measure Description for complete time frame.|Participants who had evaluable two-stage PK profiles for both Advate and baseline rFVIIIFc.||mL/h/kg||95% Confidence Interval|Geometric Mean
824276|NCT01181128|Secondary|Elimination Half Life (t1/2; Two-stage Chromogenic Assay)|Time required for the activity of the drug to reach half of its original value. Sampling for Advate PK profiling was conducted, following at least 96 hours of washout, at these timepoints: preinjection and at either 30 (±3) minutes or 10 (±3) minutes, 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 48 (±2) hours (Day 2), and 72 (±2) hours (Day 3) from the start of the injection. Sampling for rFVIIIFc PK profiling was conducted at Day 0 (directly following at least 96 hours washout from Advate PK profiling or within 4 weeks of the Advate dose or other rFVIII product) and repeated 12 to 24 weeks later at the following timepoints: preinjection and at 30 (±3) minutes (or 10 (±3) minutes), 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 72 (±2) hours (Day 3), 96 (±2) hours (Day 4), and 120 (±2) hours (Day 5) from the start of the injection.|See Measure Description for complete time frame.|Participants who had evaluable two-stage PK profiles for both Advate and baseline rFVIIIFc.||hours||95% Confidence Interval|Geometric Mean
824277|NCT01181128|Secondary|Area Under the Curve (AUC) Per Dose (Two-stage Chromogenic Assay)|Dose normalized area under the drug concentration-time curve. Sampling for Advate PK profiling was conducted, following at least 96 hours of washout, at these timepoints: preinjection and at either 30 (±3) minutes or 10 (±3) minutes, 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 48 (±2) hours (Day 2), and 72 (±2) hours (Day 3) from the start of the injection. Sampling for rFVIIIFc PK profiling was conducted at Day 0 (directly following at least 96 hours washout from Advate PK profiling or within 4 weeks of the Advate dose or other rFVIII product) and repeated 12 to 24 weeks later at the following timepoints: preinjection and at 30 (±3) minutes (or 10 (±3) minutes), 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 72 (±2) hours (Day 3), 96 (±2) hours (Day 4), and 120 (±2) hours (Day 5) from the start of the injection.|See Measure Description for complete time frame.|Participants who had evaluable two-stage PK profiles for both Advate and baseline rFVIIIFc.||IU*h/dL per IU/kg||95% Confidence Interval|Geometric Mean
824323|NCT01181271|Secondary|Number of Days After Allogeneic Transplant Until Absolute Neutrophil Count Was Equal to or Greater Than 500/uL||within 28 days after allogeneic transplant|This was only measured in the 17 participants who experienced a hematological nadir after allo transplant.||days||Full Range|Median
824324|NCT01181271|Primary|Peripheral Blood All-cell Donor Chimerism|Successful donor stem cell engraftment is defined as when ≥ 80% of hematopoietic elements are donor-derived as determined by chimerism assays from peripheral blood at day 100 after non-myeloablative allogeneic stem cell transplantation.|100 days post allogeneic transplant|Participants who underwent the full tandem AUTO-ALLO stem cell transplant||percentage of donor-derived elements||Full Range|Median
824278|NCT01181128|Secondary|Time at Maximum Activity (Tmax; Two-stage Chromogenic Assay)|Time at which the maximum activity (Cmax) is observed. Sampling for Advate PK profiling was conducted, following at least 96 hours of washout, at these timepoints: preinjection and at either 30 (±3) minutes or 10 (±3) minutes, 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 48 (±2) hours (Day 2), and 72 (±2) hours (Day 3) from the start of the injection. Sampling for rFVIIIFc PK profiling was conducted at Day 0 (directly following at least 96 hours washout from Advate PK profiling or within 4 weeks of the Advate dose or other rFVIII product) and repeated 12 to 24 weeks later at the following timepoints: preinjection and at 30 (±3) minutes (or 10 (±3) minutes), 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 72 (±2) hours (Day 3), 96 (±2) hours (Day 4), and 120 (±2) hours (Day 5) from the start of the injection.|See Measure Description for complete time frame.|Participants who had evaluable two-stage PK profiles for both Advate and baseline rFVIIIFc.||hours||95% Confidence Interval|Geometric Mean
824279|NCT01181128|Secondary|Time at Maximum Activity (Tmax; One-stage Clotting Assay)|Time at which maximum activity (Cmax) is observed. Sampling for Advate PK profiling was conducted, following at least 96 hours of washout, at these timepoints: preinjection and at either 30 (±3) minutes or 10 (±3) minutes, 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 48 (±2) hours (Day 2), and 72 (±2) hours (Day 3) from the start of the injection. Sampling for rFVIIIFc PK profiling was conducted at Day 0 (directly following at least 96 hours washout from Advate PK profiling or within 4 weeks of the Advate dose or other rFVIII product) and repeated 12 to 24 weeks later at the following timepoints: preinjection and at 30 (±3) minutes (or 10 (±3) minutes), 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 72 (±2) hours (Day 3), 96 (±2) hours (Day 4), and 120 (±2) hours (Day 5) from the start of the injection.|See Measure Description for complete time frame.|Participants who had evaluable one-stage PK profiles for both Advate and baseline rFVIIIFc.||hours||95% Confidence Interval|Geometric Mean
824280|NCT01181128|Secondary|Time to 1% and 3% FVIII Activity (Two-stage Chromogenic Assay)|Estimated time after dose (in days) when FVIII activity has declined to approximately 1 or 3 IU/dL (1% or 3%) above baseline, respectively. Sampling for Advate PK profiling was conducted, following at least 96 hours of washout, at these timepoints: preinjection and at either 30 (±3) minutes or 10 (±3) minutes, 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 48 (±2) hours (Day 2), and 72 (±2) hours (Day 3) from the start of the injection. Sampling for rFVIIIFc PK profiling was conducted at Day 0 (directly following at least 96 hours washout from Advate PK profiling or within 4 weeks of the Advate dose or other rFVIII product) and repeated 12 to 24 weeks later at the following timepoints: preinjection and at 30 (±3) minutes (or 10 (±3) minutes), 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 72 (±2) hours (Day 3), 96 (±2) hours (Day 4), and 120 (±2) hours (Day 5) from the start of the injection.|See Measure Description for complete time frame.|Participants who had evaluable two-stage PK profiles for both Advate and baseline rFVIIIFc.||days||95% Confidence Interval|Geometric Mean
824281|NCT01181128|Secondary|Time to 1% and 3% FVIII Activity (One-stage Clotting Assay)|Estimated time after dose (in days) when FVIII activity has declined to approximately 1 or 3 IU/dL (1% or 3%) above baseline, respectively. Sampling for Advate PK profiling was conducted, following at least 96 hours of washout, at these timepoints: preinjection and at either 30 (±3) minutes or 10 (±3) minutes, 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 48 (±2) hours (Day 2), and 72 (±2) hours (Day 3) from the start of the injection. Sampling for rFVIIIFc PK profiling was conducted at Day 0 (directly following at least 96 hours washout from Advate PK profiling or within 4 weeks of the Advate dose or other rFVIII product) and repeated 12 to 24 weeks later at the following timepoints: preinjection and at 30 (±3) minutes (or 10 (±3) minutes), 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 72 (±2) hours (Day 3), 96 (±2) hours (Day 4), and 120 (±2) hours (Day 5) from the start of the injection.|See Measure Description for complete time frame.|Participants who had evaluable one-stage PK profiles for both Advate and baseline rFVIIIFc.||days||95% Confidence Interval|Geometric Mean
824282|NCT01181128|Secondary|Volume at Steady State (Vss; Two-stage Chromogenic Assay)|Volume of distribution at steady state. Sampling for Advate PK profiling was conducted, following at least 96 hours of washout, at these timepoints: preinjection and at either 30 (±3) minutes or 10 (±3) minutes, 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 48 (±2) hours (Day 2), and 72 (±2) hours (Day 3) from the start of the injection. Sampling for rFVIIIFc PK profiling was conducted at Day 0 (directly following at least 96 hours washout from Advate PK profiling or within 4 weeks of the Advate dose or other rFVIII product) and repeated 12 to 24 weeks later at the following timepoints: preinjection and at 30 (±3) minutes (or 10 (±3) minutes), 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 72 (±2) hours (Day 3), 96 (±2) hours (Day 4), and 120 (±2) hours (Day 5) from the start of the injection.|See Measure Description for complete time frame.|Participants who had evaluable two-stage PK profiles for both Advate and baseline rFVIIIFc.||mL/kg||95% Confidence Interval|Geometric Mean
824283|NCT01181128|Secondary|Volume at Steady State (Vss; One-stage Clotting Assay)|Volume of distribution at steady state. Sampling for Advate PK profiling was conducted, following at least 96 hours of washout, at these timepoints: preinjection and at either 30 (±3) minutes or 10 (±3) minutes, 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 48 (±2) hours (Day 2), and 72 (±2) hours (Day 3) from the start of the injection. Sampling for rFVIIIFc PK profiling was conducted at Day 0 (directly following at least 96 hours washout from Advate PK profiling or within 4 weeks of the Advate dose or other rFVIII product) and repeated 12 to 24 weeks later at the following timepoints: preinjection and at 30 (±3) minutes (or 10 (±3) minutes), 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 72 (±2) hours (Day 3), 96 (±2) hours (Day 4), and 120 (±2) hours (Day 5) from the start of the injection.|See Measure Description for complete time frame.|Participants who had evaluable one-stage PK profiles for both Advate and baseline rFVIIIFc.||mL/kg||95% Confidence Interval|Geometric Mean
824326|NCT01181323|Secondary|Number of Maternal Participants With Season-specific LAIV Influenza A and B Strains Detected in Breast Milk Following Vaccination.|Breast milk was collected from all maternal participants prior at Days 2 and 8 post vaccination for PCR and cell culture to assess for the presence of the viruses in the LAIV vaccine. The data coordinating center selected 25% of participants in the TIV group for testing to serve as an internal control for the assay.|Day 2 and 8 post vaccination|All participants with samples selected for testing by the data coordinating center, 100% of LAIV recipients and 25% of TIV recipients, are included in the analysis.||participants|||Number
824284|NCT01181128|Secondary|Total Dose Per Injection Required for Resolution of a Bleeding Episode by Location of Bleed|For each bleeding episode at one location, the total dose is the sum of the doses (IU/kg) administered across all injections given to treat that bleeding episode. Please see Outcome Measure 20 for a definition of the efficacy period. A bleeding episode started from the first sign of a bleed, and ended 72 hours after the last treatment for the bleeding, within which any symptoms of bleeding at the same location, or injections less than or equal to 72 hours apart, were considered part of the same bleeding episode. Bleeding episodes that presented in multiple locations are included as a single event in the overall summary for dose administered to resolve that bleeding episode but are included in the individual summaries for each location.|up to 52 weeks ± 2 weeks (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc and had complete information on the dose administered to treat a bleeding episode; n=total number of bleeding episodes at this location.||IU/kg||Inter-Quartile Range|Median
824285|NCT01181128|Secondary|Number of Injections Required for Resolution of a Bleeding Episode by Location of Bleed|Please see Outcome Measure 20 for a definition of the efficacy period. A bleeding episode started from the first sign of a bleed, and ended 72 hours after the last treatment for the bleeding, within which any symptoms of bleeding at the same location, or injections less than or equal to 72 hours apart, were considered the same bleeding episode. All injections given from the initial sign of a bleed until the last date/time within the bleed window were counted. The resolution of a bleed was defined as no sign of bleeding following injection for the bleed. Bleeding episodes that presented in multiple locations are included as a single event in the overall summary for the number of injections to resolve that bleeding episode but are included in summaries for each location.|up to 52 weeks ± 2 weeks (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc and had evaluable efficacy assessments; n=total number of bleeds at given location.||injections||Inter-Quartile Range|Median
824286|NCT01181128|Secondary|Number of Injections Required for Resolution of a Bleeding Episode|A bleeding episode started from the first sign of a bleed, and ended 72 hours after the last treatment for the bleeding, within which any symptoms of bleeding at the same location, or injections less than or equal to 72 hours apart, were considered the same bleeding episode. All injections given from the initial sign of a bleed until the last date/time within the bleed window are counted. The resolution of a bleed is defined as no sign of bleeding following injection for the bleed. The efficacy period in Arms 1 and 2 began with the first prophylactic dose of rFVIIIFc and ended with the last dose (regardless of reason for dosing). The efficacy period in Arm 3 began at the time of last PK rFVIIIFc sampling timepoint and ended at the date of the last study visit. Periods of PK evaluations and surgery/rehabilitation are not included in the efficacy period.|up to 52 weeks ± 2 weeks (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc and had at least 1 bleeding episode.||injections|Bleeding Episodes|Inter-Quartile Range|Median
824287|NCT01181128|Secondary|Number of Days From Last Treatment Injection to a New Bleeding Episode|Number of days from the last injection to treat a bleeding episode to a new bleeding episode, analyzed for per evaluable bleeding episode and per participant. For “per participant” values, number of days from last injection to treat a bleed to a new bleeding episode is averaged across all evaluable bleeding episodes for each participant first, and then descriptive statistics were calculated across participants. A follow-up injection administered >72 hours after the most recent injection given to treat a bleed was considered a new bleed at the same location and was classified as type=Unknown (not evaluable). The efficacy period in Arms 1 and 2 began with the first prophylactic dose of rFVIIIFc and ended with the last dose (regardless of reason for dosing). The efficacy period in Arm 3 began at the time of last PK rFVIIIFc sampling timepoint and ended at the date of the last study visit. Periods of PK evaluations and surgery/rehabilitation were not included in the efficacy period.|up to 52 weeks ± 2 weeks (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc and had at least 1 evaluable bleeding episode. The first bleed for each participant could not be included in this analysis since there was no previous bleed from which to measure time.||days|Evaluable Bleeding Episodes|Inter-Quartile Range|Median
824288|NCT01181128|Secondary|Annualized Joint Bleeding Rate (Spontaneous and Traumatic)|Annualized bleeding episodes = (Number of bleeding episodes of the specified type / number of days in efficacy period) x 365.25. The efficacy period in Arms 1 and 2 began with the first prophylactic dose of rFVIIIFc and ended with the last dose (regardless of reason for dosing). The efficacy period in Arm 3 began at the time of last PK rFVIIIFc sampling timepoint and ended at the date of the last study visit. Periods of PK evaluations and surgery/rehabilitation were not included in the efficacy period. A bleeding episode started from the first sign of a bleed, and ended 72 hours after the last treatment for the bleeding, within which any symptoms of bleeding at the same location, or injections less than or equal to 72 hours apart, were considered the same bleeding episode.|up to 52 weeks ± 2 weeks (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc with evaluable data.||bleeding episodes per participant per yr||Inter-Quartile Range|Median
824289|NCT01181128|Secondary|Annualized Bleeding Rate by Location of Bleed (Joint, Muscle, Internal, Skin/Mucosa)|Annualized bleeding episodes = (Number of bleeding episodes at the specified location / number of days in efficacy period) x 365.25. The efficacy period in Arms 1 and 2 began with the first prophylactic dose of rFVIIIFc and ended with the last dose (regardless of reason for dosing). The efficacy period in Arm 3 began at the time of last PK rFVIIIFc sampling timepoint and ended at the date of the last study visit. Periods of PK evaluations and surgery/rehabilitation were not included in the efficacy period. A bleeding episode started from the first sign of a bleed, and ended 72 hours after the last treatment for the bleeding, within which any symptoms of bleeding at the same location, or injections less than or equal to 72 hours apart, were considered the same bleeding episode. Any bleeding at a different location was a separate bleeding episode regardless of time from the last injection.|up to 52 weeks ± 2 weeks (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc with evaluable data.||episodes per participant per year||Inter-Quartile Range|Median
824374|NCT01173523|Secondary|Overall Survival|Overall survival estimated using Kaplan-Meier (KM) methods is defined as the time from study entry to death due to any cause or date last known alive.|Long-term follow-up for survival occurred every 4 weeks. As of this analysis, follow-up among survivors was a median (range) of 11.5 months (0.9-47.9).|The analysis dataset is comprised of treated patients.||months||95% Confidence Interval|Median
824290|NCT01181128|Secondary|Investigator’s Assessment of Participants’ Bleeding Response to rFVIIIFc Injection|The investigator was given the opportunity to record an assessment of a participant’s response to treatment, if the participant was treated in the hospital for a major bleed, using the following 4-point scale: excellent=abrupt pain relief and/or improvement in signs of bleeding within approximately 8 hours after the initial injection; good=definite pain relief and/or improvement in signs of bleeding within approximately 8 hours after an injection, but possibly requiring more than one injection after 24 to 48 hours for complete resolution; moderate=probable or slight beneficial effect within 8 hours after the initial injection and requiring more than one injection; no response=no improvement, or condition worsened, within approximately 8 hours after the initial injection.|up to 52 weeks ± 2 weeks|This supplemental assessment was not summarized because of insufficient data.|||||
824291|NCT01181128|Secondary|Participant Assessment of Response to Injections to Treat a Bleeding Episode|Participant's assessment of the response to the first rFVIIIFc injection for each bleeding episode. Percentages were based on the number of bleeding episodes for which a response was provided for the first injection, using the following 4-point scale: excellent=abrupt pain relief and/or improvement in signs of bleeding within approximately 8 hours after the initial injection; good=definite pain relief and/or improvement in signs of bleeding within approximately 8 hours after an injection, but possibly requiring more than one injection after 24 to 48 hours for complete resolution; moderate=probable or slight beneficial effect within 8 hours after the initial injection and requiring more than one injection; no response=no improvement, or condition worsened, within approximately 8 hours after the initial injection.|up to 52 weeks ± 2 weeks|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc and had at least 1 evaluable bleeding episode; based on the number of injections with an evaluation.||percentage of responses|Bleeding Episodes||Number
824292|NCT01181128|Secondary|Annualized rFVIIIFc Consumption Per Participant|Consumption is calculated for the efficacy period. The efficacy period in Arms 1 and 2 began with the first prophylactic dose of rFVIIIFc and ended with the last dose (regardless of reason for dosing). The efficacy period in Arm 3 began at the time of last PK rFVIIIFc sampling timepoint and ended at the date of the last study visit. Periods of PK evaluations and surgery/rehabilitation are not included in the efficacy period. Overall units (IU/kg) of annualized rFVIIIFc consumption = [Total rFVIIIFc IU/kg received during the efficacy period / number of days in efficacy period] x 365.25.|up to 52 weeks ± 2 weeks (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc. 'Overall' n=participants in the Full Analysis Set with evaluable data in the efficacy period; 'Last 3 Months on Study' n=participants in the Full Analysis Set with evaluable data and >=6 months on study.||IU/kg rFVIIIFc per participant per year||Standard Deviation|Mean
824293|NCT01181128|Secondary|Comparison of Annualized Bleeding Rates: Arm 2 Versus Arm 3|Estimated using the negative binomial model with treatment arm as covariate, based on whole study duration for all participants. Annualized bleeding episodes = (number of bleeding episodes / number of days in the respective period)*365.25.The efficacy period in Arm 2 began with the first prophylactic dose of rFVIIIFc and ended with the last dose (regardless of reason for dosing). The efficacy period in Arm 3 began at the time of last PK rFVIIIFc sampling timepoint and ended at the date of the last study visit. Periods of PK evaluations and surgery/rehabilitation are not included in the efficacy period. A bleeding episode started from the first sign of a bleed, and ended 72 hours after the last treatment for the bleeding, within which any symptoms of bleeding at the same location, or injections less than or equal to 72 hours apart, were considered the same bleeding episode.|up to 52 weeks ± 2 weeks (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc with an efficacy assessment.||episodes per participant per year||95% Confidence Interval|Number
824294|NCT01181128|Primary|Incremental Recovery (One-stage Clotting Assay)|The rise in FVIII activity in IU/dL per unit dose administered in IU/kg. Sampling for Advate PK profiling was conducted, following at least 96 hours of washout, at these timepoints: preinjection and at either 30 (±3) minutes or 10 (±3) minutes, 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 48 (±2) hours (Day 2), and 72 (±2) hours (Day 3) from the start of the injection. Sampling for rFVIIIFc PK profiling was conducted at Day 0 (directly following at least 96 hours washout from Advate PK profiling or within 4 weeks of the Advate dose or other rFVIII product) and repeated 12 to 24 weeks later at the following timepoints: preinjection and at 30 (±3) minutes (or 10 (±3) minutes), 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 72 (±2) hours (Day 3), 96 (±2) hours (Day 4), and 120 (±2) hours (Day 5) from the start of the injection.|See Measure Description for complete time frame.|Participants who had evaluable one-stage PK profiles for both Advate and baseline rFVIIIFc.||IU/dL per IU/kg||95% Confidence Interval|Geometric Mean
824295|NCT01181128|Primary|Mean Residence Time (MRT; One-stage Clotting Assay)|The average time that a drug molecule is present in the systemic circulation. Sampling for Advate PK profiling was conducted, following at least 96 hours of washout, at these timepoints: preinjection and at either 30 (±3) minutes or 10 (±3) minutes, 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 48 (±2) hours (Day 2), and 72 (±2) hours (Day 3) from the start of the injection. Sampling for rFVIIIFc PK profiling was conducted at Day 0 (directly following at least 96 hours washout from Advate PK profiling or within 4 weeks of the Advate dose or other rFVIII product) and repeated 12 to 24 weeks later at the following timepoints: preinjection and at 30 (±3) minutes (or 10 (±3) minutes), 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 72 (±2) hours (Day 3), 96 (±2) hours (Day 4), and 120 (±2) hours (Day 5) from the start of the injection.|See Measure Description for complete time frame.|Participants who had evaluable one-stage PK profiles for both Advate and baseline rFVIIIFc.||hours||95% Confidence Interval|Geometric Mean
824325|NCT01181323|Secondary|ELISA IgA and IgG GMT to Each of the Influenza Strains in the Vaccine Received in Sera of Maternal Subjects|Blood was collected from maternal subjects on Day 0 prior to vaccination, and at Day 28 post vaccination for assessment of IgA and IgG antibodies with a standard ELISA assay. The ELISA assay was conducted with the antigens in the 2011-2012 seasonal influenza vaccine, A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008, those in the 2012-2013 seasonal influenza vaccine, A/Victoria/361/2011 and B/Wisconsin/1/2010, and the antigen in both seasons' vaccines, A/California/7/2009 (H1N1). The lower limit of detection is 5.82 units/mL for IgA and 2.56 units/mL for IgG. Titers below the limit of detection were reported as one-half the limit of detection.|Day 0 and Day 28 post vaccination|All enrolled maternal participants with results reported are included in this analysis population.||units/mL||95% Confidence Interval|Geometric Mean
824388|NCT01173848|Primary|Subjects Achieving Normal Vitamin D Levels||within 24 weeks|||participants|||Number
824296|NCT01181128|Primary|Clearance (CL; One-stage Clotting Assay)|Rate at which the body removes the drug, measured as the volume of the plasma cleared of drug per unit time per unit weight. Sampling for Advate PK profiling was conducted, following at least 96 hours of washout, at these timepoints: preinjection and at either 30 (±3) minutes or 10 (±3) minutes, 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 48 (±2) hours (Day 2), and 72 (±2) hours (Day 3) from the start of the injection. Sampling for rFVIIIFc PK profiling was conducted at Day 0 (directly following at least 96 hours washout from Advate PK profiling or within 4 weeks of the Advate dose or other rFVIII product) and repeated 12 to 24 weeks later at the following timepoints: preinjection and at 30 (±3) minutes (or 10 (±3) minutes), 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 72 (±2) hours (Day 3), 96 (±2) hours (Day 4), and 120 (±2) hours (Day 5) from the start of the injection.|See Measure Description for complete time frame.|Participants who had evaluable one-stage PK profiles for both Advate and baseline rFVIIIFc.||mL/h/kg||95% Confidence Interval|Geometric Mean
824297|NCT01181128|Primary|Elimination Half Life (t1/2; One-stage Clotting Assay)|Time required for the activity of the drug to reach half of its original value. Sampling for Advate PK profiling was conducted, following at least 96 hours of washout, at these timepoints: preinjection and at either 30 (±3) minutes or 10 (±3) minutes, 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 48 (±2) hours (Day 2), and 72 (±2) hours (Day 3) from the start of the injection. Sampling for rFVIIIFc PK profiling was conducted at Day 0 (directly following at least 96 hours washout from Advate PK profiling or within 4 weeks of the Advate dose or other rFVIII product) and repeated 12 to 24 weeks later at the following timepoints: preinjection and at 30 (±3) minutes (or 10 (±3) minutes), 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 72 (±2) hours (Day 3), 96 (±2) hours (Day 4), and 120 (±2) hours (Day 5) from the start of the injection.|See Measure Description for complete time frame.|Participants who had evaluable one-stage PK profiles for both Advate and baseline rFVIIIFc.||hours||95% Confidence Interval|Geometric Mean
824298|NCT01181128|Primary|Area Under the Curve (AUC) Per Dose (One-stage Clotting Assay)|Dose normalized area under the drug concentration-time curve. Sampling for Advate PK profiling was conducted, following at least 96 hours of washout, at these timepoints: preinjection and at either 30 (±3) minutes or 10 (±3) minutes, 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 48 (±2) hours (Day 2), and 72 (±2) hours (Day 3) from the start of the injection. Sampling for rFVIIIFc PK profiling was conducted at Day 0 (directly following at least 96 hours washout from Advate PK profiling or within 4 weeks of the Advate dose or other rFVIII product) and repeated 12 to 24 weeks later at the following timepoints: preinjection and at 30 (±3) minutes (or 10 (±3) minutes), 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 72 (±2) hours (Day 3), 96 (±2) hours (Day 4), and 120 (±2) hours (Day 5) from the start of the injection.|See Measure Description for complete time frame.|Participants who had evaluable one-stage PK profiles for both Advate and baseline rFVIIIFc.||IU*h/dL per IU/kg||95% Confidence Interval|Geometric Mean
824299|NCT01181128|Primary|Comparison of Annualized Bleeding Rates: Arm 1 Versus Arm 3|Estimated using the negative binomial model with treatment arm as covariate, based on whole study duration for all participants. Annualized bleeding episodes = (number of bleeding episodes / number of days in the respective period)*365.25.The efficacy period in Arm 1 began with the first prophylactic dose of rFVIIIFc and ended with the last dose (regardless of reason for dosing). The efficacy period in Arm 3 began at the time of last PK rFVIIIFc sampling timepoint and ended at the date of the last study visit. Periods of PK evaluations and surgery/rehabilitation are not included in the efficacy period. A bleeding episode started from the first sign of a bleed, and ended 72 hours after the last treatment for the bleeding, within which any symptoms of bleeding at the same location, or injections less than or equal to 72 hours apart, were considered part of the same bleeding episode.|up to 52 weeks ± 2 weeks (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc with an efficacy assessment.||episodes per participant per year||95% Confidence Interval|Number
824300|NCT01181128|Primary|Annualized Bleeding Rate|Annualized bleeding episodes = (number of bleeding episodes during the efficacy period / number of days during the efficacy period)*365.25. The efficacy period in Arms 1 and 2 began with the first prophylactic dose of rFVIIIFc and ended with the last dose (regardless of reason for dosing). The efficacy period in Arm 3 began at the time of last PK rFVIIIFc sampling timepoint and ended at the date of the last study visit. Periods of PK evaluations and surgery/rehabilitation are not included in the efficacy period. A bleeding episode started from the first sign of a bleed, and ended 72 hours after the last treatment for the bleeding, within which any symptoms of bleeding at the same location, or injections less than or equal to 72 hours apart, were considered the same bleeding episode.|up to 52 weeks ± 2 weeks (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc with an efficacy assessment.||episodes per participant per year||Inter-Quartile Range|Median
824301|NCT01181128|Primary|Number of Participants With Clinically Relevant Abnormalities in Vital Signs or Relevant Changes From Baseline in Vital Signs|Number of participants with clinically relevant abnormalities or relevant changes from baseline in temperature, pulse (beats per minute [bpm]), systolic blood pressure (SBP), and diastolic blood pressure (DBP) are presented. Baseline (BL) is defined as the last non-missing evaluable assessment taken prior and closest to the first rFVIIIFc dose. ↑ signifies increase and ↓ signifies decrease.|up to 52 weeks ± 2 weeks|Safety Analysis Set: participants who received at least 1 dose of Advate or at least 1 dose of rFVIIIFc and had a baseline assessment and at least one post-baseline assessment for temperature or at least one post-baseline assessment for pulse, systolic blood pressure, and diastolic blood pressure.||participants|||Number
824302|NCT01181128|Primary|Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values From Baseline|Clinical laboratory evaluations included hematology and blood chemistry. Table does not include laboratory tests evaluated during the surgical/rehabilitation period. ULN=upper limit of normal.|up to 52 weeks ± 2 weeks|Safety Analysis Set: participants who received at least 1 dose of Advate or at least 1 dose of rFVIIIFc n=the number of participants with at least one post-baseline value.||participants|||Number
824348|NCT01181349|Secondary|Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Neuromuscular Blockade Reversal Agents|Neuromuscular blockade reversal agents administered to participants undergoing surgical procedures were recorded. The number of participants who received such an agent is presented, for participants with and without residual neuromuscular blockade.|From end of surgery through PACU arrival, an expected average of 10 minutes|FAS population includes all treated participants||participants|||Number
824303|NCT01181128|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)|AE=any untoward medical occurrence that did not necessarily have a causal relationship with treatment, and could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study product, whether related or not. TEAE=AE present prior to receiving the first injection of Advate or rFVIIIFc that subsequently worsened in severity or not present prior to receiving the first injection but subsequently appeared before the last visit on study. Serious AE (SAE)=AE resulting in death, immediate risk of death, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, or a congenital anomaly/birth defect, or any other medically important event. AEs emergent between the first Advate injection and first on-study rFVIIIFc injection (Sequential PK Subgroup) or during the surgical/rehabilitation period (Surgery Subgroup) are presented separately.|up to 52 weeks + 30 days ± 1 week|Safety Analysis Set: participants who received at least 1 dose of Advate or at least 1 dose of rFVIIIFc. For Arm 1, AEs emergent between 1st on-study Advate dose and 1st rFVIIIFc dose are reported as treatment-emergent to Advate (1st column); AEs emergent after 1st rFVIIIFc injection are reported as treatment-emergent to rFVIIIFc (2nd column).||participants|||Number
824304|NCT01181128|Primary|Incidence Rate of FVIII Inhibitor Development|An inhibitor test result ≥0.6 Bethesda units (BU)/mL, identified and confirmed by re-testing of a second sample obtained within 2 to 4 weeks, was considered positive. Both tests were to be performed using the Nijmegen-modified Bethesda Assay by the central laboratory. The incidence rates along with the 95% confidence interval (CI) were summarized for all titers for subjects with 50 or more exposure days (EDs) to rFVIIIFc and a valid inhibitor test after the 50th exposure. In addition, the incidence rates for all subjects regardless of their exposure days to rFVIIIFc were also summarized. The 95% CI was calculated using Clopper-Pearson exact method.|up to 52 weeks ± 2 weeks|Safety Analysis Set: participants who received at least 1 dose of Advate or at least 1 dose of rFVIIIFc; n=number of participants with given number of exposure days who had a valid inhibitor test.||percentage of participants||95% Confidence Interval|Number
824305|NCT01181141|Secondary|Proportion of Subjects With Venous Thromboembolism Events.||2 weeks||||||
824306|NCT01181141|Primary|The Incidence of Major or Clinically Relevant Non-major Bleeding|Bleeding events during the period from the start of treatment with the study drug (study treatment) to the day of the follow-up examination were assessed as the primary endpoints.|2 weeks|Safety Analysis Set defined as all subjects who were secondarily enrolled in study, but excluded those with significant GCP violations, did not receive any study drug, or had no safety data after start of study treatment. However, subjects who had significant GCP violations, but received at least one dose of study drug, safety data were assessed.||percentage of subjects with bleeds||95% Confidence Interval|Number
824307|NCT01181167|Secondary|Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding||2 weeks|Safety analyses were performed for the Safety Analysis Set, which was defined as all subjects who were secondarily enrolled in the study, but excluded those who had significant GCP violations, who had not received any doses of the study drug, or who had no safety data after the start of study treatment.||percentage of subjects with bleeds||95% Confidence Interval|Number
824308|NCT01181167|Primary|Incidence of Subjects With Venous Thromboembolism Events|"The primary efficacy endpoint was the proportion of subjects who experienced at least one of the thromboembolic events listed below during the period from the start of study treatment to the venography at the end of study treatment.
Lower extremity DVT confirmed by bilateral venography at the end of study treatment
Definite diagnosis of symptomatic PE
Symptomatic DVT confirmed before the venography at the end of study treatment The objectives were to verify the non-inferiority of edoxaban to enoxaparin with regard to prevention of VTE"|2 weeks|The FAS was defined as all subjects enrolled in the study, but excluded those who had significant GCP violations, who had not received any doses of the study drug, or those who did not develop symptomatic DVT or PE, but in whom venography was not appropriately performed.||percentage of subjects with vte events||95% Confidence Interval|Number
824309|NCT01181258|Secondary|Patients With Expansion of NK Cells|Number of patients who experience in vivo expansion of allogeneic donor natural killer (NK) cells.|Day 14|||Participants|||Count of Participants
824310|NCT01181258|Secondary|Time to Disease Progression|Cumulative incidence will be used to determine time to disease progression.|Day 1 through Month 12|10 participants had disease progression||days||Full Range|Median
824311|NCT01181258|Secondary|Serious Adverse Events|Number of participants experiencing serious adverse events that occur during study. Adverse event collection for the purposes of this study will focus on targeted adverse events and unexpected adverse events at specific time points in relation to the NK cell infusion and post infusion IL2 injections.|Day 1 through Month 12|||Participants|||Count of Participants
824312|NCT01181258|Primary|Objective Response Rate|The number of patients with an objective response rate (Partial Response +Complete Response) at 2 months post haploidentical NK cell infusion in patient with refractory/relapsed NHL or chronic lymphocytic leukemia (CLL).|Month 2 Post Infusion|One participant died of sepsis a week after therapy and was not evaluable.||Participants|||Count of Participants
824313|NCT01181271|Secondary|Estimated Two Year Overall Survival Rate for Participants Undergoing Only Autologous Transplant||two years|Participants who ONLY underwent Autologous transplant, did not proceed to Allogeneic transplant||percentage of participants||90% Confidence Interval|Number
824314|NCT01181271|Secondary|Estimated Two Year Progression Free Survival Rate for Participants Undergoing Only Autologous Transplant||Two Years|Participants who ONLY underwent Autologous transplant (did not proceed to Allogeneic)||percentage of participants||90% Confidence Interval|Number
824315|NCT01181271|Secondary|Estimated Two Year Overall Survival Rate for All Participants||2 years|||percentage of participants||90% Confidence Interval|Number
824316|NCT01181271|Secondary|Estimated Two Year Progression Free Survival Rate for All Participants||2 years|||percentage of participants||90% Confidence Interval|Number
824317|NCT01181271|Secondary|Estimated Two Year Overall Survival Rate for Participants Undergoing Both Autologous and Allogeneic Transplants||Two-years after Allogeneic Transplant|||percentage of participants||90% Confidence Interval|Number
824318|NCT01181271|Secondary|Estimated Two Year Progression Free Survival Rate for Participants Undergoing Both Autologous and Allogeneic Transplants||2 years after allogeneic transplant|||percentage of participants||90% Confidence Interval|Number
824319|NCT01181271|Secondary|Cumulative Incidence of Disease Relapse||2-years after allogeneic transplant|||percentage of participants||90% Confidence Interval|Number
824327|NCT01181323|Secondary|Number of Maternal Participants Positive for the Season-specific LAIV Influenza A Strain in Respiratory Secretions at Day 8 Who Were Positive for H1N1 and/or H3N2 Strains.|Nasal swab samples were collected from all maternal participants at Day 8 post vaccination for PCR and cell culture to assess for the presence of the viruses in the LAIV vaccine in respiratory secretions. Those who were positive for the Influenza A strain were further tested to identify the H1N1 and H3N2 strain.|Day 8 post vaccination|The analysis population is limited to participants who were positive by PCR and/or cell culture for the vaccine strain of Influenza A.||participants|||Number
824328|NCT01181323|Secondary|Number of Maternal and Infant Participants Positive for the Season-specific LAIV Influenza A Strain in Respiratory Secretions at Day 2 Who Were Positive for H1N1 and/or H3N2 Strains.|Nasal swab samples were collected from all maternal and infant participants at Day 2 post vaccination for PCR and cell culture to assess for the presence of the viruses in the LAIV vaccine in respiratory secretions. Those who were positive for the Influenza A strain were further tested to identify the H1N1 and H3N2 strain.|Day 2 post vaccination|The analysis population is limited to participants who were positive by PCR and/or cell culture for the vaccine strain of Influenza A.||participants|||Number
824329|NCT01181323|Secondary|Number of Maternal Participants Positive for the Season-specific LAIV Influenza A Strain in Respiratory Secretions at Day 0 Who Were Positive for H1N1 and/or H3N2 Strains.|Nasal swab samples were collected from all maternal participants prior to vaccination for PCR and cell culture to assess for the presence of the viruses in the LAIV vaccine in respiratory secretions. Those who were positive for the Influenza A strain were further tested to identify the H1N1 and H3N2 strain.|Day 0 prior to vaccination|The analysis population is limited to participants who were positive by PCR and/or cell culture for the vaccine strain of Influenza A.||participants|||Number
824330|NCT01181323|Secondary|Number of Infant Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions at Day 8 Post Vaccination.|Nasal swab samples were collected from all infant participants at Day 8 post vaccination for PCR and cell culture to assess for the presence of the viruses in the LAIV vaccine in respiratory secretions. The data coordinating center selected 25% of participants in the TIV group for testing to serve as an internal control for the assay.|Day 8 post vaccination|All participants with samples selected for testing by the data coordinating center, 100% of LAIV recipients and 25% of TIV recipients, are included in the analysis.||participants|||Number
824331|NCT01181323|Secondary|Number of Infant Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions at Day 2 Post Vaccination.|Nasal swab samples were collected from all infant participants at Day 2 post vaccination for PCR and cell culture to assess for the presence of the viruses in the LAIV vaccine in respiratory secretions. The data coordinating center selected 25% of participants in the TIV group for testing to serve as an internal control for the assay.|Day 2 post vaccination|All participants with samples selected for testing by the data coordinating center, 100% of LAIV recipients and 25% of TIV recipients, are included in the analysis.||participants|||Number
824332|NCT01181323|Secondary|Number of Infant Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions Prior to Vaccination.|Nasal swab samples were collected from all infant participants prior to vaccination for PCR and cell culture to assess for the presence of the viruses in the LAIV vaccine in respiratory secretions. The data coordinating center selected 25% of participants in the TIV group for testing to serve as an internal control for the assay.|Day 0 prior to vaccination|All participants with samples selected for testing by the data coordinating center, 100% of LAIV recipients and 25% of TIV recipients, are included in the analysis.||participants|||Number
824333|NCT01181323|Secondary|Number of Maternal Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions at Day 8 Post Vaccination.|Nasal swab samples were collected from all maternal participants at Day 8 post vaccination for PCR and cell culture to assess for the presence of the viruses in the LAIV vaccine in respiratory secretions. The data coordinating center selected 25% of participants in the TIV group for testing to serve as an internal control for the assay.|Day 8 post vaccination|All participants with samples selected for testing by the data coordinating center, 100% of LAIV recipients and 25% of TIV recipients, are included in the analysis.||participants|||Number
824334|NCT01181323|Primary|Number of Maternal Participants Reporting Solicited Quantitative Local Symptoms After Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of redness and swelling for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Day 0-7 post vaccination|All enrolled maternal participants are included in this analysis population.||participants|||Number
824335|NCT01181323|Primary|Number of Maternal Participants Reporting Solicited Subjective Local Symptoms After Vaccination|Participants maintained a memory aid to record daily the occurrence of local symptoms of nasal congestion, runny nose, cough, sore throat, nasal bleeding, pain at injection site, tenderness at injection site, and swelling at injection site for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Day 0-7 post vaccination|All enrolled maternal participants are included in this analysis population.||participants|||Number
824336|NCT01181323|Primary|Number of Maternal Participants Reporting Solicited Subjective Systemic Symptoms After Vaccination|Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, nausea, weakness, and chills for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Day 0-7 post vaccination|All enrolled maternal participants are included in this analysis population.||participants|||Number
824337|NCT01181323|Primary|Number of Maternal Participants Reporting Fever After Vaccination|Participants were provided with a thermometer and a memory aid on which to record daily oral temperatures for 8 days after vaccination (Day 0-7). The protocol defined fever as oral temperature of 37.8 degrees Celsius or higher. Participants are counted as experiencing fever if they reported oral temperatures of 37.8 degrees Celsius or higher on any of the 8 days.|Day 0-7 post vaccination|All enrolled maternal participants are included in this analysis population.||participants|||Number
824338|NCT01181323|Secondary|Number of Maternal Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions at Day 2 Post Vaccination.|Nasal swab samples were collected from all maternal participants at Day 2 post vaccination for PCR and cell culture to assess for the presence of the viruses in the LAIV vaccine in respiratory secretions. The data coordinating center selected 25% of participants in the TIV group for testing to serve as an internal control for the assay.|Day 2 post vaccination|All participants with samples selected for testing by the data coordinating center, 100% of LAIV recipients and 25% of TIV recipients, are included in the analysis.||participants|||Number
824339|NCT01181323|Secondary|Number of Maternal Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions Prior to Vaccination.|Nasal swab samples were collected from all maternal participants prior to vaccination for PCR and cell culture to assess for the presence of the viruses in the LAIV vaccine in respiratory secretions. The data coordinating center selected 25% of participants in the TIV group for testing to serve as an internal control for the assay.|Day 0 prior to vaccination|All participants with samples selected for testing by the data coordinating center, 100% of LAIV recipients and 25% of TIV recipients, are included in the analysis.||participants|||Number
824340|NCT01181323|Secondary|Geometric Mean Titers (GMT) in Maternal Sera of Hemagglutination Inhibition (HAI) Antibodies to Each of the Influenza Strains in the Vaccine Received|Blood was collected for HAI assay at Day 0 prior to vaccination and again at 28 days following vaccination. The HAI assay was conducted with the antigens in the 2011-2012 seasonal influenza vaccine, A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008, those in the 2012-2013 seasonal influenza vaccine, A/Victoria/361/2011 and B/Wisconsin/1/2010, and the antigen in both seasons's vaccine, A/California/7/2009 (H1N1). The lower limit of detection for the assay was a titer of 10, sera samples below detection were given a value of 5 for analysis.|Day 0 and 28 post vaccination|All enrolled maternal participants with results reported are included in this analysis population.||titer||95% Confidence Interval|Geometric Mean
824341|NCT01181323|Primary|Number of Infant Participants With Medically Attended Respiratory or Gastrointestinal AEs 28-42 Days After Maternal Vaccination|Maternal participants were contacted by telephone at Day 42 to report all medically attended respiratory or gastrointestinal adverse events occurring in the infant participants between 28 and 42 days after maternal vaccination.|Within 28-42 days after maternal vaccination|All infant participants for whom the maternal participants were contacted are included in the analysis population description. One maternal participant was not contacted.||participants|||Number
824342|NCT01181323|Primary|Breast Milk ELISA IgA and IgG Geometric Mean Titers (GMT) to Each of the Vaccine Influenza Strains|Breast milk was collected at Day 0 prior to vaccination and again at 28 days following vaccination for testing in IgA and IgG ELISA Assays. The ELISA assay was conducted with the antigens in the 2011-2012 seasonal influenza vaccine, A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008, those in the 2012-2013 seasonal influenza vaccine, A/Victoria/361/2011 and B/Wisconsin/1/2010, and the antigen in both seasons's vaccine, A/California/7/2009 (H1N1). The lower limit of detection is 5.82 units/mL for IgA and 2.56 units/mL for IgG. Titers below the limit of detection were reported as one-half the limit of detection.|Day 0 and 28 post vaccination|All enrolled maternal participants are included in this analysis population.||units/mL||95% Confidence Interval|Geometric Mean
824343|NCT01181323|Primary|Number of Participating Reporting Non-serious Unsolicited Adverse Events Related to Vaccination Within 28 Days of Maternal Vaccination|Adverse events (AE) for this protocol used the International Conference on Harmonization (ICH) guideline E6 definition of AE, any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product regardless of its causal relationship to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational product. Related was defined as a reasonable possibility that the study product caused the AE. Reasonable possibility means that there is evidence to suggest a causal relationship between the study product and the adverse event. Non-serious AEs were those that did not meet the definition of serious (see Outcome Measure 1). Maternal participants were queried at each visit through 28 days after vaccination for the occurrence of any AE for her or the infant separately from the pre-defined solicited symptoms.|Day 0 to Day 28 post vaccination|All enrolled participants are included in the analysis population for this outcome measure||participants|||Number
824344|NCT01181323|Primary|Number of Infant Participants Reporting Solicited Systemic Adverse Events Within 11 Days of Maternal Vaccination|Maternal participants maintained a memory aid to record daily the occurrence in their infants of systemic adverse events of fever (defined as rectal temperature 37.8 degrees Celsius or greater), drowsiness, irritability/fussiness, loss of appetite, nasal congestion, difficulty breathing, runny nose, and cough for 11 days (Day 0-10) after maternal vaccination based on protocol-defined grading (none, mild, moderate or severe) for each symptom. Rectal temperature was measured once daily. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 11 days.|Day 0 to Day 10 post vaccination|||participants|||Number
824345|NCT01181323|Primary|Number of Participants Reporting New Onset Chronic Medical Conditions|New onset chronic medical condition was defined as any new ICD-10 diagnosis for a participant that was expected to continue for at least 6 months and require continued health care intervention. ICD-10 = International Statistical Classification of Diseases and Related Health Problems, 10th revision. Maternal participants were asked at each visit through 180 days after enrollment if they or their infants had any new diagnosis.|Day 0 to Day 180 post vaccination|All enrolled participants are included in the analysis population for this outcome measure.||participants|||Number
824346|NCT01181323|Primary|Number of Participants Reporting Serious Adverse Events (SAEs)|Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation thereof; was a congenital anomaly/birth defect; or may have jeopardized the participant, or required intervention to prevent one of the outcomes, regardless of relationship to study product or study participation.|Day 0 to Day 180 post vaccination|All enrolled participants are included in the analysis population for this outcome measure.||participants|||Number
824347|NCT01181349|Secondary|Number of Participants With and Without Postoperative Residual Neuromuscular Blockade With Postoperative Events||From end of surgery through hospital discharge, an expected average of 6 days|FAS population includes all treated participants||participants|||Number
824349|NCT01181349|Secondary|Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Propofol or Sevoflurane|Anesthetic agents administered to participants undergoing surgical procedures were recorded. The number of participants who received propofol or sevoflurane is presented, for participants with and without residual neuromuscular blockade.|From start of surgery through PACU arrival|FAS population includes all treated participants; for this outcome measure only participants who received propofol or sevoflurane are included||participants|||Number
824350|NCT01181349|Secondary|Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Identified Neuromuscular Blocking Agents|Neuromuscular blocking agents administered to participants undergoing surgical procedures were recorded. The number of participants who received atracurium, cisatracurium, rocuronium or vecuronium is presented, for participants with and without residual neuromuscular blockade.|From start of surgery through PACU arrival|FAS population includes all treated participants; for this outcome measure only participants who received atracurium, cisatracurium, rocuronium or vecuronium are included||participants|||Number
824351|NCT01181349|Primary|Number of Participants With Train-of-four (TOF) Ratio <0.9 at PACU Arrival|The incidence of incomplete postoperative neuromuscular recovery from general anesthesia was assessed in study participants upon arrival in the PACU, after their respective surgical procedures were completed. Neuromuscular functioning was assessed by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. The TOF ratio is the ratio of the magnitude of the fourth twitch to that of the first twitch, and a ratio <0.9 indicates residual neuromuscular blockade (incomplete neuromuscular recovery).|Upon arrival in the PACU|Full analysis set (FAS) population includes all treated participants||participants|||Number
824352|NCT01173211|Secondary|Number of Participants With HAI Antibody Titer Greater Than or Equal to 40 Against Each Antigen Included in the 2010-2011 Inactivated TIV in Cord Blood Collected at Time of Delivery.|Cord blood was collected at delivery for HAI assay at time of delivery. The HAI assay was conducted with the three antigens in the 2010-2011 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen. Participants are counted if the titer at the timepoint is 40 or greater.|At time of delivery|Subjects from whom cord blood samples were collected at delivery from which valid results were reported are included.||participants|||Number
824353|NCT01173211|Secondary|HAI GMT Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine in Cord Blood Collected at Time of Delivery|Cord blood was collected at delivery for HAI assay at time of delivery. The HAI assay was conducted with the three antigens in the 2010-2011 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen.|At time of delivery|Subjects from whom cord blood samples were collected at delivery from which valid results were reported are included.||Titers||95% Confidence Interval|Mean
824354|NCT01173211|Secondary|Number of Participants With a Maternal Serum HAI Antibody Titer Greater Than or Equal to 40 Against Each Antigen Included in the 2010-2011 Inactivated TIV at Time of Delivery.|Maternal blood was collected for HAI assay at time of delivery. The HAI assay was conducted with the three antigens in the 2010-2011 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen. Participants are counted if the titer at the timepoint is 40 or greater.|At time of delivery|Subjects who contributed blood samples at delivery from which valid results were reported are included.||participants|||Number
824355|NCT01173211|Secondary|Number of Participants With 4-fold or Greater Maternal Serum HAI Antibody Titer Increases Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine at Time of Delivery|Blood was collected from all participants prior to vaccination as well as at time of delivery. The HAI assay was conducted with the three antigens in the 2010-2011 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 10 (the assay's lowest level of detection) and the titer was 40 or greater at delivery, or the Day 0 titer was greater than or equal to 10 and the titer was an increase by 4-fold or more at delivery.|Day 0 prior to vaccination and at time of delivery|Subjects who contributed blood samples at delivery from which valid results were reported are included.||participants|||Number
824356|NCT01173211|Primary|Number of Participants With HAI Antibody Titer of 40 or Greater Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine|Blood was collected from all participants prior to vaccination as well as 28 days after vaccination. The HAI assay was conducted with the three antigens in the 2010-2011 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen. Participants are counted if the titer at the timepoint is 40 or greater.|Day 0 prior to and Day 28 after vaccination|Subjects who received vaccination and contributed blood samples from which valid results were reported are included. One subject who did not meet eligibility criteria was not included.||participants|||Number
824357|NCT01173211|Primary|Number of Participants With 4-fold or Greater Serum HAI Antibody Titer Increases Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine|Blood was collected from all participants prior to vaccination as well as 28 days after vaccination. The HAI assay was conducted with the three antigens in the 2010-2011 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 10 (the assay's lowest level of detection) and the Day 28 post vaccination titer was 40 or greater, or the Day 0 titer was greater than or equal to 10 and the Day 28 post vaccination titer was an increase by 4-fold or more.|Day 0 prior to and Day 28 after vaccination|||participants|||Number
824358|NCT01173211|Primary|Hemagglutination Inhibition Assay (HAI) Geometric Mean Titer (GMT) Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine|Blood was collected for HAI assay at Day 0 prior to vaccination and again at 28 days following vaccination. The HAI assay was conducted with the three antigens in the 2010-2011 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen.|Day 0 prior to and Day 28 following vaccination|Subjects who received vaccination and contributed blood samples from which valid results were reported are included. One subject who did not meet eligibility criteria was not included.||Titers||95% Confidence Interval|Geometric Mean
824359|NCT01173211|Secondary|Maternal HAI GMT Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine at Time of Delivery|Maternal blood was collected for HAI assay at time of delivery. The HAI assay was conducted with the three antigens in the 2010-2011 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen.|At time of delivery|Subjects who contributed blood samples at delivery from which valid results were reported are included.||Titers||95% Confidence Interval|Geometric Mean
824360|NCT01173211|Secondary|Number of Participants With HAI Antibody Titer of 40 or Greater Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine at 6 Months After Vaccination|Blood was collected from all participants at 180 days after vaccination. The HAI assay was conducted with the three antigens in the 2010-2011 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen. Participants are counted if the titer at the timepoint is 40 or greater.|Day 180 (approximately 6 months after vaccination)|Subjects who received vaccination and contributed blood samples from which valid results were reported are included.||participants|||Number
824361|NCT01173211|Primary|Number of Participants Reporting Fever After Vaccination|Participants were provided with a thermometer and a memory aid on which to record daily oral temperatures for 8 days after vaccination (Day 0-7). The protocol defined fever as oral temperature of 37.8 degrees Celsius or higher. Participants are counted as experiencing fever if they reported oral temperatures of 37.8 degrees Celsius or higher on any of the 8 days.|8 days after vaccination (Days 0-7).|All participants receiving the vaccination are included in the safety cohort.||participants|||Number
824362|NCT01173211|Primary|Number of Participants Reporting Solicited Subjective Systemic Reactions After Vaccination|Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|8 days after vaccination (Days 0-7).|All participants receiving the vaccination are included in the safety cohort.||participants|||Number
824363|NCT01173211|Primary|Number of Participants Reporting Solicited Quantitative Local Reactions After Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of redness and swelling for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|8 days after vaccination (Days 0-7).|All participants receiving the vaccination are included in the safety cohort.||participants|||Number
824364|NCT01173211|Secondary|Number of Participants With 4-fold or Greater Serum HAI Antibody Titer Increases Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine at 6 Months After Vaccination|Blood was collected from all participants at 180 days after vaccination. The HAI assay was conducted with the three antigens in the 2010-2011 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 10 (the assay's lowest level of detection) and the Day 180 post vaccination titer was 40 or greater, or the Day 0 titer was greater than or equal to 10 and the Day 180 post vaccination titer was an increase by 4-fold or more.|Day 180 (approximately 6 months after vaccination)|Subjects who received vaccination and contributed blood samples from which valid results were reported are included.||participants|||Number
824365|NCT01173211|Secondary|Hemagglutination Inhibition Assay (HAI) Geometric Mean Titer (GMT) Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine at 6 Months After Vaccination|Blood was collected for HAI assay at approximately Day 180 following vaccination. The HAI assay was conducted with the three antigens in the 2010-2011 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen.|Day 180 (approximately 6 months after vaccination)|Subjects who received vaccination and contributed blood samples from which valid results were reported are included.||Titer||95% Confidence Interval|Geometric Mean
824366|NCT01173211|Primary|Number of Participants Reporting Solicited Subjective Local Reactions After Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|8 days after vaccination (Days 0-7).|All participants receiving the vaccination are included in the safety cohort.||participants|||Number
824367|NCT01173211|Primary|Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)|Serious adverse events included any untoward medical occurrence that resulted in death of the mother, fetus or infant; was life threatening to mother, fetus or infant; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof; was a congenital anomaly/birth defect in fetus or infant; or may have jeopardized the mother, fetus or infant, or required intervention to prevent one of the outcomes, or was described as Guillain-Barré Syndrome. Association was determined by a clinician licensed to diagnose and listed on the site's FDA Form 1572.|Day 0 through Day 180 after vaccination|All participants receiving vaccination are included in the safety cohort||participants|||Number
824368|NCT01173211|Primary|Number of Participants Reporting Neonatal Complications|Participants were contacted after delivery, and medical records reviewed, to collect neonatal complications. The data collection process followed a prospectively-defined list of complications reported for this outcome measure, some of which may have also been reported as serious adverse events if otherwise meeting those requirements.|At time of delivery|Pregnant participants receiving vaccination are included in this outcome measure.||participants|||Number
824369|NCT01173211|Primary|Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery|Participants were contacted after delivery, and medical records reviewed, to collect complications experienced during pregnancy, labor and delivery. The data collection process followed a prospectively-defined list of complications reported for this outcome measure, some of which may have also been reported as serious adverse events if otherwise meeting those requirements.|During the pregnancy and at the time of delivery|Pregnant participants receiving vaccination are included in this outcome measure.||participants|||Number
824370|NCT01173211|Primary|Number of Participants Reporting Vaccine-associated Unsolicited Non-serious Adverse Events|Unsolicited non-serious adverse events were collected from participants at follow up contacts, either by phone or in clinic, through 28 days after vaccination. Association to vaccination was determined by a clinician licensed to make a medical diagnosis and listed on the site's Federal Drug Administration's Form 1572.|Day 0 through Day 28 post vaccination|All participants receiving vaccination are included in the safety cohort||participants|||Number
824371|NCT01173471|Secondary|Change in Mean Intra-ocular Pressure Compared With Baseline After 4 Weeks Treatment||Baseline to 4 weeks|Efficacy analysis set||mmHg||95% Confidence Interval|Least Squares Mean
824372|NCT01173471|Secondary|Clinically Relevant Change in Intra-ocular Pressure After 4 Weeks of Treatment||Baseline to 4 weeks|Efficacy analysis set||Participants|||Number
824375|NCT01173523|Secondary|Progression-Free Survival|Progression-free survival (PFS) based on the Kaplan-Meier method is defined as the time from study entry to the earliest documentation of disease progression (PD) based on RECIST 1.1 criteria or death. Participants alive without evidence of PD were censored at the date of last adequate disease assessment. Per RECIST 1.1 for target lesions PD is at least a 20% increase in sum LD, taking as reference the smallest sum on study with at least 5 mm absolute increase. For non-target lesions, progression is appearance of one or more new lesions and/or unequivocal progression on existing non-target lesions.|Disease was evaluated radiographically at baseline and every 8 weeks on treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles in this study cohort.|The analysis dataset is comprised of all treated patients.||months||95% Confidence Interval|Median
824376|NCT01173523|Secondary|Overall Response Rate|The objective response rate (ORR) was defined as the percentage of participants achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.|Disease was evaluated radiographically at baseline and every 8 weeks on treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles in this study cohort.|The analysis dataset is comprised of all treated patients.||percentage of participants||95% Confidence Interval|Number
824377|NCT01173523|Primary|8-Week Progression-Free Rate|The 8-week progression free rate is defined as the percentage of participants achieving complete response (CR), partial response (PR) or stable disease (SD) based on RECIST 1.1 criteria by the time of the first disease assessment (8 weeks). Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions; PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD; and SD is neither sufficient decrease to qualify as PR nor sufficient increase to qualify as progressive disease (PD). PD is at least a 20% increase in sum LD, taking as reference the smallest sum on study with at least 5 mm absolute increase. Response needed confirmation within 4 weeks. For non-target lesions, progression-free means no new lesions or unequivocal progression on existing non-target lesions or not evaluated.|Disease was evaluated radiographically at baseline and every 8 weeks on treatment; Treatment continued until disease progression or unacceptable toxicity. Relevant for this endpoint was the first 8 week disease re-assessment.|The analysis dataset is comprised of all treated patients.||percentage of participants||95% Confidence Interval|Number
824378|NCT01173653|Primary|Smoking Status at Follow up|Patients enrolled in this study were contacted via phone to assess smoking status. Smoking status was a self-report from each subject. Primary outcome measure is the smoking status of the enrollee at the time of follow-up contact. We calculated the percentage of participants who had stopped smoking at the 6 week follow-up period in each arm|6 weeks|Of subjects enrolled, 56 of the 109 subjects in the control arm and 49 of 90 subjects in the intervention arm were able to be contacted via phone and were willing to provide follow-up data for analysis of smoking status at the 6 week follow-up.||percentage of participants|||Number
824379|NCT01173679|Secondary|Toxicities|Dasatinib may enhance the myelosuppression expected from fludarabine. This toxicity will be monitored with frequent CBC's. If after Day 21 of a cycle there is a grade 4 cytopenia, a dose reduction will occur in the next cycle of treatment, and that cycle cannot start until the ANC > 1,000 and the platelets > 25,000. There is also a risk for pleural effusions with dasatinib, but the risk will be low, since there is a break from dasatinib dosing on days 15-28 of each cycle. Nevertheless, if a grade 2 pleural effusion occurs, there will be a dose reduction in the next cycle of treatment.|2 years|||Participants|||Count of Participants
824380|NCT01173679|Secondary|Progression-Free and Overall Survival|To describe the progression-free and overall surivial|2 years|||months||Inter-Quartile Range|Median
824381|NCT01173679|Primary|Response Rate|To describe the response rate of complete response (CR) and partial response (PR) to treatment with this drug combination (SD=stable disease, PD=progressive disease)|2 years|||Participants|||Count of Participants
824382|NCT01173718|Secondary|Time to Potential Central Venous Catheter Removal|The time to potential central venous catheter removal is defined as the time from the initial study procedure to the third consecutive cannulation through the GORE® ACUSEAL Vascular Graft in which hemodialysis is carried out. The third consecutive cannulation is a surrogate endpoint for time to CVC removal. Typically, CVC removal is ordered after the third consecutive cannulation.|Initial study procedure to the third consecutive cannulation, assessed from day 3 thru day 123|All subjects with unknown time to potential central venous catheter removal at the 6 month window were omitted from calculations||days||Full Range|Median
824383|NCT01173718|Secondary|Time to First Cannulation|The time to first cannulation is defined as the time from access placement to the first cannulation of the GORE® ACUSEAL Vascular Graft.|Time of access placement to first cannulation, assessed up to one week|All subjects with unknown time to first cannulation at the 6 month window were omitted from calculations||percentage of grafts|||Number
824384|NCT01173718|Secondary|Time to Event Analysis (Cumulative Patency)|The cumulative patency at 6 months and time-to-loss of cumulative patency will be estimated using the Kaplan-Meier survival curve for time-to-event analysis to obtain estimates accounting for censoring.|6 Months|All subjects with unknown time to event analysis (cumulative patency) status at the 6 month window were omitted from calculations||percentage of participants||95% Confidence Interval|Number
824385|NCT01173718|Secondary|Primary Unassisted Patency at 6 Months|The primary unassisted patency is defined as the percentage of subjects free from the first occurence of either access thrombosis or an access procedure performed to maintain access patency.|6 Months|All subjects with unknown primary unassisted patency status at the 6 month window were omitted from calculations||percentage of participants|||Number
824386|NCT01173718|Primary|Freedom From Bleeding at 6 Months|Percentage of subjects free from both major and minor bleeding events, assessed at 6-months|6 Months|All subjects with unknown bleeding status at the 6 month window were omitted from calculations||percentage of participants||95% Confidence Interval|Number
824387|NCT01173718|Primary|Cumulative Patency at 6 Months|Percentage of subjects free from loss of access for hemodialysis at the study access site, assessed at 6 month.|6 Months|All subjects with unknown cumulative patency status at the 6 month window were omitted from calculations||percentage of participants||95% Confidence Interval|Number
824389|NCT01173874|Secondary|Efficacy as Measured by Positive and Negative Syndrome Scale (PANSS)|"Total PANSS score with 30 items. Each item is rated 1-7 so the minimum Total PANSS score =30 and the maximum is 210. Anchors for each item are as follows, the higher values represent an increase in severity of symptoms:
Absent
Minimal
Mild
Moderate
Moderately severe
Severe
Extremely severe"|4-6 month period|Completed subjects||units on a scale||Standard Deviation|Mean
824390|NCT01173874|Secondary|Cognition as Measured by Cognitive Assessment Interview (CAI)|"Cognitive Assessment Interview was used to obtain information about cognitive functioning from both subject and an informant. Composite CAI scores were reported. Scale ranges from 1-7 with the following anchors:
Normal, no cognitive impairment
Borderline impairment
Mildly impaired
Moderately impaired
Markedly impaired
Severely impaired
Among the most extremely impaired"|4-6 month period|completed subjects with available completed CAI data. Numbers above are correct as not all completed subjects (Analysis Population Description) had completed CAI assessment available for analysis.||units on a scale||Standard Deviation|Mean
824391|NCT01173874|Primary|Cognitive Function as Measured by the University of California, San Diego, Performance-Based Skills Assessment-Brief (UPSA-B) Scale|The UPSA-B assesses functional capacity to perform tasks similar to those in daily life. Raw scores are converted into scaled scores ranging from 0–100, with higher scores indicating better functional capacity.|4-6 month period|Completed subjects||units on a scale||Standard Deviation|Mean
824392|NCT01173874|Primary|Cognitive Function Measured by MCCB Composite Score|"The MATRICS Consensus Cognitive Battery (MCCB) will be used to assess cognitive function. The MCCB composite score is comprised of sub-scale measures of: a) working memory; b) attention and vigilance; c) verbal learning; d) visual learning; e) speed of processing; f) reason and problem solving; and g) social cognition. The MCCB takes 90 minutes or less to complete.
MCCB assessed 4 times: prestabilization (screening), randomization (after 6-8 weeks of lurasidone stabilization, prior to initial cognitive remediation), midpoint (after 20 cognitive remediation session), and study completion (final visit after 30 cognitive remediation sessions).
MCCB composite scores are reported as t-scores where a t-score = 50 is the population average. Every 10 points is one standard deviation. There is no range as scores are as far from population average."|4-6 month period|Completers||units on a scale||Standard Deviation|Mean
824393|NCT01174004|Secondary|Motor Symptoms Change From Baseline (Negative = Improvement)|"Motor symptoms were measured using the change from baseline to Day 43 in the combined score of the Unified Parkinson’s Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) and Part III (Motor Examination). The possible total score is 0 to 160 and a negative change in score indicates improvement.
Analysis Method: Analysis of Covariance (ANCOVA). The UPDRS Parts II+III score was analyzed by constructing 2-sided 95% confidence intervals (CIs) on the difference between the pimavanserin dose group and placebo mean change from baseline. Non-inferiority was concluded if the upper limit of the CI was less than or equal to 5."|Study Days 1 and 43|This is the “Intent to Treat” population, defined as patients who received at least one dose of study drug and had both the baseline SAPS assessment and at least one post-baseline SAPS assessment collected no later than 3 days after the last dose date.||Score on the UPDRS-II+III||95% Confidence Interval|Least Squares Mean
824394|NCT01174004|Primary|Antipsychotic Efficacy|"Antipsychotic Efficacy was defined as a decrease in the severity and/or frequency of hallucinations and/or delusions. This is measured as the change from baseline (Day 1) to Day 43 in the Scale for the Assessment of Positive Symptoms 9-item sum score for Parkinson’s Disease (SAPS-PD). The possible total score is 0 to 45 and a negative change in score indicates improvement.
Analysis Method: Mixed Model Repeated Measures (MMRM)"|Each study visit (i.e. Days 1, 15, 29 and 43)|"This is the Intent to Treat population, defined as patients who received at least one dose of study drug and had both the baseline SAPS assessment and at least one post-baseline SAPS assessment collected no later than 3 days after the last dose date."||Score on the SAPS-PD scale||95% Confidence Interval|Least Squares Mean
824395|NCT01174030|Secondary|PSA-5 Success|"Each concentration/regimen was compared to its respective placebo control as part of the primary analysis.
PSA-5 success defined as 2-grade improvement on PSA-5.
Patient Self Assessment - 5 (PSA-5) - Grade/description 0 / No redness
/ Very mild redness
/ Mild redness
/ Moderate redness
/ Severe redness"|day 29|ITT population, LOCF when the data are missing at all four timepoints (i.e. Hours 3,6,9,12) LOCF method will be applied from the previous visit.||participants|||Number
824396|NCT01174030|Secondary|CEA Success|"CEA success defined as 2-grade improvement on CEA.
Each concentration/regimen was compared to its respective placebo control as part of the primary analysis.
Clinician Erythema Assessment (CEA) - Grade/Description 0 / Clear Skin with no signs of erythema
/ Amost clear; slight redness
/ Mild erythema; definite redness
/ Moderate erythema; marked redness
/ Severe erythema; fiery redness"|Day 29|ITT population, LOCF when the data are missing at all four timepoints (i.e. Hours 3,6,9,12) LOCF method will be applied from the previous visit.||participants|||Number
824397|NCT01174030|Primary|Composite Success|"Composite success defined as 2-grade improvement on Clinician Erythema Assessment (CEA)and Patient Self Assessment-5 (PSA-5).
Each concentration/regimen was compared to its respective placebo control as part of the primary analysis."|Day 29|Intent-to Treat (ITT) population, LOCF when the data are missing at all four timepoints (i.e. Hours 3, 6, 9, 12) LOCF method will be applied from previous visit.||participants|||Number
824398|NCT01174043|Other Pre-specified|Mechanistic Attributes of Erlotinib Hydrochloride in AML, Including Intracellular Quantitative Protein and Gene Expression Modifications and the in Vivo Effect of This Agent on the Differentiation of AML Blasts||Baseline; days 3, 4, 8, and 29 of course 1; and day 29 of courses 3, 6, 9, and 12||||||
824399|NCT01174043|Secondary|Treatment Related Adverse Events Grade 3 or Higher|Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Grading scale will be from 1 (mild) to 5 (causing death). This will determine the number of unique patients who had a treatment related (possible, probable or definite) adverse event that was graded 3 or greater.|up to 15 months|||participants|||Number
824400|NCT01174043|Secondary|Duration of Response (up to One Year Follow up) in Patients Who Achieve a Complete Remission|The duration of response is from the time of response until failure or until the end of follow-up for the patients who received complete remission. Complete remission includes presence of less than 5% blasts in an aspirate sample with marrow spicules and with a count of at least 200 nucleated cells.|1 year after treatment discontinuation|All patients enrolled and received treatment||months||Standard Deviation|Mean
824401|NCT01174043|Primary|Overall Response Rate (Defined as Partial Remission or Better) to 3 Months of Treatment With Erlotinib|The percent of patients were shown as having a partial remission or better based on definitions of response in AML. Partial remission includes a decrease of at least 50% in the percentage of blasts to 5% to 25% in the bone marrow aspirate. Complete remission includes presence of less than 5% blasts in an aspirate sample with marrow spicules and with a count of at least 200 nucleated cells. The percent and 95% exact confidence intervals will be calculated.|3 months of treatment with erlotinib|All patients enrolled and received treatment||percentage of participants||95% Confidence Interval|Number
824402|NCT01174160|Primary|Proportion of Patients With Treatment-induced Conversion of Atrial Fibrillation to Sinus Rhythm|The proportion of patients with treatment-induced conversion of atrial fibrillation to sinus rhythm for a minimum duration of 1 minute|Within 90 minutes after first exposure|||participants|||Number
824403|NCT01174173|Secondary|Right Ventricular Hemodynamics|Mean pulmonary artery pressure was assessed invasively by right heart catheterization at the conclusion of the study to estimate right ventricular hemodynamics.|3 months|Analysis was performed on all participants who completed right heart catheterization at the conclusion of the study||mm Hg||Standard Deviation|Mean
824404|NCT01174173|Secondary|Absolute RV Longitudinal Strain|Change in absolute right ventricular (RV) longitudinal strain as assessed by exercise stress echocardiography with speckle-tracking echocardiography at baseline and conclusion of the study. An increase in exercise-induced change in RV longitudinal strain between baseline to conclusion of the study is indicative of improved RV function. If absolute RV longitudinal strain increases with exercise, that is a sign that the RV is working well. If absolute RV longitudinal strain decreases with exercise, that is a sign that the RV is not working well. Therefore, between baseline and conclusion of the study, if exercise-induced change in RV strain increases that means that the RV is working better at the conclusion of the study.|3 months|Analysis was performed on all participants who completed exercise stress echocardiography at baseline and conclusion of the study (month 3)||percentage||Standard Deviation|Mean
824405|NCT01174173|Secondary|RV Perfusion on Cardiac MRI|The majority of patients did not undergo cardiac MRI because it was difficult for the patients to tolerate the imaging study. Therefore, we were not able to assess change in RV perfusion.|3 months||||||
824406|NCT01174173|Primary|Improve Quality of Life|The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. The scores are averaged and transformed to a range of 0-100, in which higher scores reflect better health status and was performed at the conclusion of the study.|3 Months|Analysis was performed on the 8 participants who completed the KCCQ questionnaire at baseline and at the conclusion of the study (month 3)||KCCQ Summary Score||Standard Deviation|Mean
824407|NCT01174173|Primary|6-Minute Walk Test|Improve Exercise Capacity measured by 6-Minute Walk Test|3 Months|Analysis was performed in all participants who completed the study and had a 6-minute walk test at baseline and at the conclusion of the study.||meters||Standard Deviation|Mean
824408|NCT01174173|Primary|Improve Angina Symptoms|Assessed as average improvement in WHO Functional Class. The WHO Functional Class score ranges from 1 to 4, with higher scores indicating more impairment|3 months|Analysis was performed on all participants who completed as average change in WHO Functional class score from baseline to 3 months (Baseline, 3 months)||units on a scale||Standard Deviation|Mean
824409|NCT01174186|Secondary|Assessment Group in Ankylosing Spondylitis (ASAS) Core Set for Clinical Practice|clinical measurements of inflammation in spondyloarthritis patients as described by the Assessment Group in Ankylosing Spondylitis (ASAS)|one year||||||
824410|NCT01174186|Secondary|Spondyloarthritis Consortium of Canada Score|Inflammation on MRI assessed by the Spondyloarthritis Consortium of Canada score and a Danish scoring method|one year||||||
824411|NCT01174186|Primary|Change in Intestinal Inflammation Measured by Faecal Calprotectin|"Feacal calprotectin is a protein and a marker of the degree of inflammation in the intestine, but not the site of inflammation.
We measured the level calprotectin continuously in each of the patients. Difference was inferred by repeated measurement ANOVA"|Baseline to 52 weeks|"15 patients in each group was included. 3 in the calprotectin negative group patients did not fulfill the entire study period (1 lost to follow-up, 2 withdrew consent).
Data analysed as last observation carried forward."||mg/g||Inter-Quartile Range|Median
824412|NCT01174186|Primary|Change Lewis Score Index|"Lewis' score describes the amount of inflammation seen optically by capsular endoscopy.
Gralnek et al. devised and validated the Lewis score index, based on three endoscopic parameters: villous edema, ulcer and stenosis/stricture. Using these parameters, the authors established a score range of 8–4,800 points where: LS < 135 reflects normal mucosal appearances, LS 135–790 mild mucosal inflammatory change and an LS value ≥790 moderate to severe mucosal inflammatory changes.
The patients had endoscopy performed at baseline and again after 20 weeks. The number of patients improving was compared to number of patients deteriorating"|20 weeks|Because endoscopy has a small risk for perforation. The study was designed so only patients with active inflammation at baseline had follow-up endoscopy performed. Because all patients with normal calprotectin levels had normal endoscopy, follow-up was only performed on this group of patients.||units on a scale||Inter-Quartile Range|Median
824413|NCT01174264|Primary|Tmax Following Steady State Exposure for 14 Days|Time of maximum drug concentration.|24 hours|||hours||Standard Deviation|Mean
824414|NCT01174264|Primary|AUC Following Steady State Exposure for 14 Days|Area under the curve from 0 to 24 hours.|24 hours|3 and 2 patients with missing data, respectively||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
824415|NCT01174264|Primary|Cmax Following Steady State Exposure for 14 Days|Maximum drug concentration over 24 hours.|24 hours|||ng/ml||Geometric Coefficient of Variation|Geometric Mean
824416|NCT01174264|Primary|Ctrough Following Steady State Exposure for 14 Days|Minimum blood concentration over 24-hour observation period. Blood sample collected at 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 24 hours.|24 hours|||ng/ml||Geometric Coefficient of Variation|Geometric Mean
824417|NCT01174264|Primary|Tlag Following Single Dose of Drug|Time between drug administration and when it is first observed in the systemic circulation.|168 hours|||hours||Standard Deviation|Mean
824418|NCT01174264|Primary|Tmax`Following Single Dose of Drug|Time of maximum drug concentration|168 hours|||hours||Standard Deviation|Mean
824419|NCT01174264|Secondary|Objective Responses in Patients With Solid Tumors|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 30 days|2 patients in Arm I and 4 patients in Arm III were non-evaluable for response.||participants|||Number
824420|NCT01174264|Primary|AUC Following Single Dose of Drug|Area under the curve from 0-168 hours.|168 hours|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
824421|NCT01174264|Primary|Cmax Following Single Dose of Drug|Highest observed concentration over the 168 hour period. Blood samples were collected at j0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 24, 48, 120, and 168 hours.|168 hours|||ng/ml||Geometric Coefficient of Variation|Geometric Mean
824422|NCT01174342|Primary|Intraocular Pressure|Intraocular pressure during different stages of child delivery.|During child delivery|We included in the analysis all women completing vaginal delivery that had measurements of their intraocular pressure during most stages of labor.||mm Hg||Standard Deviation|Mean
824423|NCT01174446|Secondary|Health Resource Use - Days Lost From Work or School||Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week, Study Part 3 = 1 week (Total = 29-31 weeks)|Full Analysis Set||Days||Full Range|Median
824424|NCT01174446|Secondary|Health Resource Use - Unscheduled Doctor's Office Visits||Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week, Study Part 3 = 1 week (Total = 29-31 weeks)|Full Analysis Set||Visits||Full Range|Median
824425|NCT01174446|Secondary|Health Resource Use - Emergency Room Visits||Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week, Study Part 3 = 1 week (Total = 29-31 weeks)|Full Analysis Set||Visits||Full Range|Median
824426|NCT01174446|Secondary|Health Resource Use - Total Days of Hospital Stay||Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week, Study Part 3 = 1 week (Total = 29-31 weeks)|Full Analysis Set||Days||Full Range|Median
824427|NCT01174446|Secondary|Health Resource Use - Number of Hospitalizations||Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week, Study Part 3 = 1 week (Total = 29-31 weeks)|Full Analysis Set||Hospitalizations||Full Range|Median
824428|NCT01174446|Secondary|Health-Related Quality of Life (HRQoL) Disease-specific: Haemo-QoL - Participants On-Demand (Ages 12-16)|The Haemo-QoL is a quality of life (QoL) assessment instrument for children and adolescents with haemophilia. As a hemophilia-specific instrument, this measure assesses very specific aspects of dealing with hemophilia. For the Haemo-QoL, higher scores indicate a worse quality of life. Scores on a scale range between 0 and 100.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set||Score on a scale||Standard Deviation|Mean
824429|NCT01174446|Secondary|Health-Related Quality of Life (HRQoL) Disease-specific: Haem-A-QoL|The Haem-A-QOL instrument has been developed and used in hemophilia A patients. As a hemophilia-specific instrument, this measure assesses very specific aspects of dealing with hemophilia. The areas covered by this instrument are: physical health, sports/leisure, school/work, dealing with hemophilia, and outlook for the future. For the Haem-A-QOL, higher scores indicate a worse quality of life. Scores on a scale range between 0 and 100.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set||Score on a scale||Standard Deviation|Mean
824430|NCT01174446|Secondary|Pediatric Quality of Life Questionnaire (PedsQL) Total Score (Ages 12-16)|The Peds-QL is a generic Health-Related Quality of Life (HR QoL) instrument designed specifically for a pediatric population. It captures the following domains: general health/activities, feelings/emotional, social functioning, school functioning. For this study, the Peds-QL for 12 to 16-year-old subjects was used. Higher scores indicate better quality of life (QOL) for all domains of the Peds-QL. This modular instrument uses a 5-point scale: from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. 4 dimensions (physical, emotional, social, & school functioning) are scored.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set||Score on a scale||Standard Deviation|Mean
824431|NCT01174446|Secondary|Pediatric Quality of Life Questionnaire (PedsQL) Psychosocial Health Summary Score (Ages 12-16)|The Peds-QL is a generic Health-Related Quality of Life (HR QoL) instrument designed specifically for a pediatric population. It captures the following domains: general health/activities, feelings/emotional, social functioning, school functioning. For this study, the Peds-QL for 12 to 16-year-old subjects was used. Higher scores indicate better quality of life (QOL) for all domains of the Peds-QL. This modular instrument uses a 5-point scale: from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. 4 dimensions (physical, emotional, social, & school functioning) are scored.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set||Score on a scale||Standard Deviation|Mean
824432|NCT01174446|Secondary|Pediatric Quality of Life Questionnaire (PedsQL) Physical Health Summary Score (Ages 12-16)|The Peds-QL is a generic Health-Related Quality of Life (HR QoL) instrument designed specifically for a pediatric population. It captures the following domains: general health/activities, feelings/emotional, social functioning, school functioning. For this study, the Peds-QL for 12 to 16-year-old subjects was used. Higher scores indicate better quality of life (QOL) for all domains of the Peds-QL. This modular instrument uses a 5-point scale: from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. 4 dimensions (physical, emotional, social, & school functioning) are scored.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set||Score on a scale||Standard Deviation|Mean
824433|NCT01174446|Secondary|SF-36: HRQoL General Health|Quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set||Score on a scale||Standard Deviation|Mean
824449|NCT01174446|Secondary|Number of Participants With Clinically Significant Changes in Laboratory Parameters: Vital Signs|Clinically significant changes in vital signs assessments for pulse rate, systolic/diastolic blood pressure, respiratory rate, body temperature|Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week, Study Part 3 = 1 week (Total = 29-31 weeks)|Full Analysis Set||participants|||Number
824434|NCT01174446|Secondary|SF-36: HRQoL Social Functioning|Quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set||Score on a scale||Standard Deviation|Mean
824435|NCT01174446|Secondary|SF-36: HRQoL Vitality|Quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set||Score on a scale||Standard Deviation|Mean
824436|NCT01174446|Secondary|SF-36: HRQoL Mental Health|Quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set||Score on a scale||Standard Deviation|Mean
824437|NCT01174446|Secondary|SF-36: HRQoL Bodily Pain|Quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set||Score on a scale||Standard Deviation|Mean
824438|NCT01174446|Secondary|SF-36: HRQoL Role-Emotional|Quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set||Score on a scale||Standard Deviation|Mean
824439|NCT01174446|Secondary|SF-36: HRQoL Role-Physical (RP)|Quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set||Score on a scale||Standard Deviation|Mean
824440|NCT01174446|Secondary|SF-36: HRQoL Physical Functioning' (PF)|Quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set||Score on a scale||Standard Deviation|Mean
824441|NCT01174446|Secondary|SF-36: HRQoL 'Mental Health' (MH)|Quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set||Score on a scale||Standard Deviation|Mean
824442|NCT01174446|Secondary|Short Form (36) Health Survey (SF-36): HRQoL 'Physical Component Score' (PCS)|The PCS is a summary scale of the dimensions physical functioning, role physical, bodily pain, and general health. The component score is normalized to a standard population. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set||Score on a scale||Standard Deviation|Mean
824443|NCT01174446|Secondary|General Pain Assessment Through a Visual Analog Scale (VAS)|Participant rated assessment of health-related quality of life. The VAS Pain Scale rates current health state on a scale from 0 (no pain) to 100 (worst imaginable pain). For the pain scale, a higher score indicates worse pain.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set||Score on a scale||Standard Deviation|Mean
824444|NCT01174446|Secondary|EuroQoL (Quality of Life)-5 Dimensions Visual Analogue Scale (EQ-5D VAS) Scores|Participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better quality of life.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set||Score on a scale||Standard Deviation|Mean
824445|NCT01174446|Secondary|EuroQoL (Quality of Life)-5 Dimensions (EQ-5D) Total Index Scores|EQ-5D is a participant answered questionnaire scoring 5 dimensions - mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ-5D total score ranges from 0 (worst health state) to 1 (perfect health state) and 1 reflects the best outcome.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set||Score on a scale||Standard Deviation|Mean
824446|NCT01174446|Secondary|Number of Participants With Adverse Events (AEs) After BAX326 Treatment||Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week, and Study Part 3 = 1 week (Total = 29-31 weeks)|||participants|||Number
824447|NCT01174446|Secondary|Number of Adverse Events (AEs) After BAX326 Treatment||Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week, and Study Part 3 = 1 week (Total = 29-31 weeks)|Full Analysis Set||adverse events|||Number
824448|NCT01174446|Secondary|Number of Participants With Clinically Significant Changes in Laboratory Parameters: Thrombogenic Markers|Clinically significant changes in thrombogenic markers assessments for thrombin-antithrombin (TAT), prothrombin fragment 1.2, and D-dimer as evaluated by an independent Data Monitoring Committee (DMC)|Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week, Study Part 3 = 1 week (Total = 29-31 weeks)|Full Analysis Set||participants|||Number
824450|NCT01174446|Secondary|Number of Participants With Clinically Significant Changes in Laboratory Parameters: Hematology|Clinically significant changes in hematology assessments for Basophils, Basophils/Leukocytes, Eosinophils, Eosinophils/Leukocytes, Erythrocyte Mean Corpuscular Hemoglobin Concentration, Erythrocyte Mean Corpuscular Volume, Erythrocytes, Hematocrit, Hemoglobin, Leukocytes, Lymphocytes, Lymphocytes/Leukocytes, Monocytes, Monocytes/Leukocytes, Neutrophils, Neutrophils/Leukocytes, Platelets,|Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week, Study Part 3 = 1 week (Total = 29-31 weeks)|Full Analysis Set||participants|||Number
824451|NCT01174446|Secondary|Number of Participants With Clinically Significant Changes in Laboratory Parameters: Clinical Chemistry|"Clinically significant changes in chemistry assessments for Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Bicarbonate, Bilirubin, Blood Urea Nitrogen, Chloride, Glucose, Potassium, Protein (Serum), Sodium.
Clinically Significant (CS) defined as:
1. The abnormal value constitutes an adverse event (AE) and,
2. The abnormal value is a symptom of or related to a disease that is already recorded as an AE in Case Report Form (CRF)."|Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week, Study Part 3 = 1 week (Total = 29-31 weeks)|Full Analysis Set||participants|||Number
824452|NCT01174446|Secondary|Number of Participants Who Experienced Thrombotic Events||Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week, Study Part 3 = 1 week (Total = 29-31 weeks)|Full Analysis Set||participants|||Number
824453|NCT01174446|Secondary|Number of Participants Who Experienced Severe Allergic Reactions (e.g. Anaphylaxis)||Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week, Study Part 3 = 1 week (Total = 29-31 weeks)|Full Analysis Set||participants|||Number
824454|NCT01174446|Secondary|Occurrence of Treatment Related Total Binding Antibodies|Occurrence of treatment related total binding antibodies to Factor IX (FIX), antibodies to Chinese hamster ovary (CHO) proteins, and recombinant furin (rFurin) is defined by more than 2-dilution increase as compared to levels at screening visit and confirmed specificity (e.g. negative to 1:80)|Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week, Study Part 3 = 1 week (Total = 29-31 weeks)|Full Analysis Set||participants|||Number
824455|NCT01174446|Secondary|Occurrence of Total Binding Antibodies of Indeterminate Specificity (Within Assay Variability)|Occurrence of total binding antibodies of indeterminate specificity (within assay variability) to FIX, antibodies to CHO proteins and rFurin is defined by a dilution of 2 or less increase as compared to levels at screening visit (e.g. negative to 1:20 or 1:40).|Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week, Study Part 3 = 1 week (Total = 29-31 weeks)|Full Analysis Set||participants|||Number
824456|NCT01174446|Secondary|Number of Participants Who Developed Inhibitory Antibodies to Factor IX (FIX)||Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week, Study Part 3 = 1 week (Total = 29-31 weeks)|Full Analysis Set||participants|||Number
824457|NCT01174446|Secondary|Consumption of BAX326 Per Participant: Median Weight-adjusted Consumption Per Month||Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week (Prophylaxis and On-Demand period), Study Part 3 = 1 week (Total = 29-31 weeks)|Full Analysis Set||IU/kg||Inter-Quartile Range|Median
824458|NCT01174446|Secondary|Consumption of BAX326 Per Participant: Median Number of Infusions Per Month||Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week (Prophylaxis and On-Demand period), Study Part 3 = 1 week (Total = 29-31 weeks)|Full Analysis Set||Infusions||Inter-Quartile Range|Median
824459|NCT01174446|Secondary|Consumption of BAX326 Per Event Per Participant|Weight-adjusted consumption of BAX326 by event per participant, i.e., for prophylactic treatment and for treatment of bleeds until resolution of bleed.|Study Part 2 = 26 weeks ± 1 week (Note: Study Part 1 = 2-4 weeks)|Full Analysis Set||IU/kg||Inter-Quartile Range|Median
824460|NCT01174446|Secondary|Total Weight-adjusted Dose Per Bleeding Episode (BEs) of All BEs Treated With BAX326 by Bleeding Site and Cause||Study Part 2 = 26 weeks ± 1 week (Note: Study Part 1 = 2-4 weeks)|Full Analysis Set||IU/kg|Participants|Inter-Quartile Range|Median
824461|NCT01174446|Secondary|Hemostatic Efficacy at Resolution of All Bleeding Episodes (BEs) Treated With BAX326 by Bleeding Site and Cause|"Rating Scale for Treatment of BEs (4-point ordinal scale):
Excellent: Full relief of pain and cessation of objective signs of bleeding (eg, swelling, tenderness, and decreased range of motion in the case of musculoskeletal hemorrhage) after a single infusion. No additional infusion required for the control of bleeding. Administration of further infusions to maintain hemostasis did not affect this scoring.
Good: Definite pain relief and/or improvement in signs of bleeding after a single infusion. Possibly requires more than 1 infusion for complete resolution.
Fair: Probable and/or slight relief of pain and slight improvement in signs of bleeding after single infusion. Required more than 1 infusion for complete resolution.
None: No improvement or condition worsens."|At bleed resolution throughout the study period of 22 months (Study Parts 1, 2, and 3)|Full Analysis Set||Bleeding episodes|Participants||Number
824462|NCT01174446|Secondary|Bleeding Episodes Treated With 1, 2 or ≥3 Infusions of BAX326 by Bleeding Site and Cause|The number of bleeding episodes treated with 1, 2, or ≥3 infusions of BAX326 to achieve adequate hemostasis. Only infusions required until resolution of bleed were considered.|Study Part 2 = 26 weeks ± 1 week (Study Part 2 began at week 3-5)|Full Analysis Set||Bleeding episodes|Participants||Number
824463|NCT01174446|Secondary|Study Part 2: Annualized Bleed Rate (ABR) During Treatment With BAX326|ABR during prophylaxis (twice-weekly) in Part 2 was calculated as (Number of bleeding episodes/observed treatment period in days) * 365.25. The treatment period on prophylaxis was defined as time between the first and the last prophylactic infusions and ABR on prophylaxis was calculated for participants who received a minimum of 3 months of prophylactic treatment with BAX326.|Study Part 2 = 26 weeks ± 1 week (Note: Study Part 1 = 2-4 weeks)|Full Analysis Set - Prophylactic cohort||Bleeds per year||Inter-Quartile Range|Median
824464|NCT01174446|Secondary|Study Parts 1 and 3: Volume of Distribution at Steady State (Vss)|"Vss computed as CL·MRT.
The objective of Study Part 3 was to re-evaluate the Pharmacokinetic (PK) parameters for BAX 326 after a period of 6 months of treatment, in participants who accumulated at least 30 EDs to BAX 326, and to compare them with those determined in the same participants participating in Study Part 1."|0-30 minutes before infusion up to 72 hours post-infusion|"Pharmacokinetic Per Protocol Analysis Set (PKPPAS)
-Participants who participated in Study Parts 1-3 and completed Study Part 1 without any major protocol deviations"||dL/kg||Inter-Quartile Range|Median
824488|NCT01174576|Primary|Energy ad Libitum Meal|The energy of first meal 3 hr after ingestion|3 hr post ingestion|||kcal||Standard Deviation|Mean
824465|NCT01174446|Secondary|Study Parts 1 and 3: Half Life (T 1/2)|"Elimination phase half-life will be determined as ln2/ λz.
The objective of Study Part 3 was to re-evaluate the Pharmacokinetic (PK) parameters for BAX 326 after a period of 6 months of treatment, in participants who accumulated at least 30 EDs to BAX 326, and to compare them with those determined in the same participants participating in Study Part 1."|0-30 minutes before infusion up to 72 hours post-infusion|"Pharmacokinetic Per Protocol Analysis Set (PKPPAS)
-Participants who participated in Study Parts 1-3 and completed Study Part 1 without any major protocol deviations"||Hour||Inter-Quartile Range|Median
824466|NCT01174446|Secondary|Change in Incremental Recovery (IR) at 30 Minutes Over Time|The median changes in IR at 30 Minutes, calculated as the change in IR value from exposure day 1 (ED1).|0-30 minutes before infusion and 30 minutes post-infusion|"Pharmacokinetic Per Protocol Analysis Set (PKPPAS)
-Participants who participated in Study Parts 1-3 and completed Study Part 1 without any major protocol deviations"||(IU/dL) / (IU/kg)||Inter-Quartile Range|Median
824467|NCT01174446|Secondary|Incremental Recovery (IR) at 30 Minutes Over Time|"IR at 30 Minutes was measured at the following time points during the study:
Part 1 or Part 2, Exposure Day (ED) 1. (If participant was present for Study Part 1, then ED 1 from Part 1 was used. If Participant entered study in Study Part 2, then ED 1 from Part 2 was used.)
Part 2: Week 5
Part 2: Week 13
Part 2 or Part 3: Week 26 (Week 26 of study participation)
Study Completion or Termination Visit"|0-30 minutes before infusion and 30 minutes post-infusion|"Pharmacokinetic Per Protocol Analysis Set (PKPPAS)
-Participants who participated in Study Parts 1-3 and completed Study Part 1 without any major protocol deviations"||(IU/dL) / (IU/kg)||Inter-Quartile Range|Median
824468|NCT01174446|Secondary|Study Parts 1 and 3: Incremental Recovery at Cmax (IR at Cmax)|"Defined as (Cmax - Cpre-infusion)/Dose, where maximum concentration (Cmax) will be determined as the highest concentration achieved within one hour after infusion.
The objective of Study Part 3 was to re-evaluate the Pharmacokinetic (PK) parameters for BAX 326 after a period of 6 months of treatment, in participants who accumulated at least 30 EDs to BAX 326, and to compare them with those determined in the same participants participating in Study Part 1."|0-30 minutes before infusion up to 1 hour post-infusion|"Pharmacokinetic Per Protocol Analysis Set (PKPPAS)
-Participants who participated in Study Parts 1-3 and completed Study Part 1 without any major protocol deviations"||(IU/dL) / (IU/kg)||Inter-Quartile Range|Median
824469|NCT01174446|Secondary|Study Parts 1 and 3: Clearance (CL)|"Computed as Dose/ AUC0-∞.
The objective of Study Part 3 was to re-evaluate the Pharmacokinetic (PK) parameters for BAX 326 after a period of 6 months of treatment, in participants who accumulated at least 30 EDs to BAX 326, and to compare them with those determined in the same participants participating in Study Part 1."|0-30 minutes before infusion up to 72 hours post-infusion|"Pharmacokinetic Per Protocol Analysis Set (PKPPAS)
-Participants who participated in Study Parts 1-3 and completed Study Part 1 without any major protocol deviations"||dL/(kg·hr)||Inter-Quartile Range|Median
824470|NCT01174446|Secondary|Study Parts 1 and 3: Mean Residence Time (MRT)|"Computed as Area under the moment curve 0-∞ (AUMC0-∞) / AUC0-∞- TI/2, where AUMC0-∞ will be determined in a similar manner as AUC0-∞ and TI represents infusion duration [hr]
The objective of Study Part 3 was to re-evaluate the Pharmacokinetic (PK) parameters for BAX 326 after a period of 6 months of treatment, in participants who accumulated at least 30 EDs to BAX 326, and to compare them with those determined in the same participants participating in Study Part 1."|0-30 minutes before infusion up to 72 hours post-infusion|"Pharmacokinetic Per Protocol Analysis Set (PKPPAS)
-Participants who participated in Study Parts 1-3 and completed Study Part 1 without any major protocol deviations"||Hour||Inter-Quartile Range|Median
824471|NCT01174446|Secondary|Study Parts 1 and 3: Area Under the Plasma Concentration/Time Curve From Time 0 to Infinity Per Dose (AUC0-∞/ Dose)|"Defined as (AUC0-t + Ct)/ λz/ dose, where t is the time of last quantifiable concentration, Ct is the last quantifiable concentration. λz will be estimated from the slope of natural log-linear fitting to latter quantifiable concentrations, with largest adjusted R^2.
The objective of Study Part 3 was to re-evaluate the Pharmacokinetic (PK) parameters for BAX 326 after a period of 6 months of treatment, in participants who accumulated at least 30 EDs to BAX 326, and to compare them with those determined in the same participants participating in Study Part 1."|0-30 minutes before infusion up to 72 hours post-infusion|"Pharmacokinetic Per Protocol Analysis Set (PKPPAS)
-Participants who participated in Study Parts 1-3 and completed Study Part 1 without any major protocol deviations"||(IU·hr)/ dL/ (IU/kg)||Inter-Quartile Range|Median
824472|NCT01174446|Primary|Study Part 1- Area Under the Plasma Concentration Versus Time Curve From 0 to 72 Hours Per Dose|Computed using the linear trapezoidal method. The concentration at 72 hours was interpolated from the two nearest sampling time points or extrapolated using the last quantifiable concentration and the terminal rate constant λz. λz was estimated from the slope of natural log-linear fitting to latter quantifiable concentrations, with largest adjusted R^2.|72 hours|"Pharmacokinetic Per Protocol Analysis Set (PKPPAS)
-Participants who participated in Study Parts 1-3 and completed Study Part 1 without any major protocol deviations"||(IU·hr/dL) / (IU/kg)||Inter-Quartile Range|Median
824473|NCT01174459|Secondary|Change From Baseline in Total Score of the International Restless Legs Syndrome Rating Scale (IRLS)|International Restless Legs Syndrome rating scale (IRLS): The IRLS rating scale is a selfrating scale used to evaluate the severity of RLS and the patients are requested to answer 10 questions on a scale of 0 to 4. Respective scores (0-4 points) for the 10 questions were added up to calculate the total score on the IRLS. Therefore the total score is 0-40. The lower values represent a better outcome.|after 12 months or at the end of observation|Efficacy set: The patient set included all patients in the safety set with approved indication RLS and had IRLS total score measurement at baseline and at least one post-baseline time point.||Score on a scale||Standard Error|Mean
824474|NCT01174459|Primary|Incidence of Drug-related Adverse Events|Number of patients with drug-related adverse events|12 Months|Safety set: all patients who were documented to have taken at least one dose of pramipexole except for patients who had no observation documented after entry, made invalid registration or were not under the appropriate site contact.||participants|||Number
824475|NCT01174550|Secondary|Cumulative Radiation Exposure Within 90 Days|Cumulative radiation exposure from all cardiovascular diagnostic tests and procedures performed within 90 days after randomization.|90 days|||milliSievert (mSv)||Inter-Quartile Range|Median
824508|NCT01175018|Secondary|Percentage of Patients in Each Group With Reverse Remodeling (Reduction in LVESVi >10%)||10-14 weeks|||% of participants|||Number
824476|NCT01174550|Secondary|Quality of Life (QOL) as Measured by Complete Resolution of Symptoms That Led to the Initial Testing|Percentage of participants with improvement in Quality of Life as measured by complete resolution of the symptoms that led to initial testing|6 month, 12 month 24 month|The number of participants were limited due to budget constraints.||% of participants|||Number
824477|NCT01174550|Secondary|Quality of Life (QOL) as Measured by Seattle Anginal Quality of Life Subscale|Participant score Quality of Life measured by Seattle Angina Scale Anginal Frequency Subscale utilizing the Seattle Angina Questionnaire (SAQ). SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease: Anginal Stability: whether symptoms are changing. Anginal Frequency: how often patient having symptoms Physical Limitation: how much condition hampers ability to do what he wants.Treatment Satisfaction: how well patient understands care. Disease Perception: impact of condition on interpersonal relationships. Each dimension assigns response an value, beginning with 1 for response at the lowest level of functioning & summing across items within each of the 5 scales. Scale scores transformed to 0-100 range by subtracting the lowest scale. Higher score suggest symptoms more stable & less frequent, condition has less impact on activities, increased satisfaction with treatment, & perception of disease has less impact on interpersonal relationships.|Baseline, 6 months, 12 months, 24 months|The number of participants were limited due to budget constraints.||participant score||Inter-Quartile Range|Median
824478|NCT01174550|Secondary|Quality of Life (QOL) as Measured by Seattle Angina Scale Anginal Frequency Subscale|Participant score Quality of Life measured by Seattle Angina Scale Anginal Frequency Subscale utilizing the Seattle Angina Questionnaire (SAQ). SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease: Anginal Stability: whether symptoms are changing. Anginal Frequency: how often patient having symptoms Physical Limitation: how much condition hampers ability to do what he wants.Treatment Satisfaction: how well patient understands care. Disease Perception: impact of condition on interpersonal relationships. Each dimension assigns response an value, beginning with 1 for response at the lowest level of functioning & summing across items within each of the 5 scales. Scale scores transformed to 0-100 range by subtracting the lowest scale. Higher score suggest symptoms more stable & less frequent, condition has less impact on activities, increased satisfaction with treatment, & perception of disease has less impact on interpersonal relationships.|Baseline, 6 month, 12 month, 24 month|The number of participants were limited due to budget constraints.||participant score||Inter-Quartile Range|Median
824479|NCT01174550|Secondary|Quality of Life (QOL) as Measured by Duke Activity Status Index|Participant score in Quality of Life as measured by Duke Activity Status Index (DASI). DASI measures a person's functional capacity based on a 12-item questionnaire that correlates with peak O2 uptake during exercise testing. The DASI is a self-administered questionnaire that measures a patient's functional capacity. It can be used to get a rough estimate of a patient's peak oxygen uptake. The maximum score for the DASI is 58.2 (better functional ability/capacity) and the minimum score is 0 (worse functional ability/capacity).|Baseline, 6 months, 12 months 24 months|The number of participants were limited due to budget constraints.||participant score||Inter-Quartile Range|Median
824480|NCT01174550|Secondary|Medical Cost|Assess and compare total medical cost for the two diagnostic testing arms by intention to treat at both 90 days and 3 years cumulative.|90 days and 3 years cumulative|Patients enrolled in PROMISE and cared for in the fee-for-service sector of the US health care system were included in the economic study. Because the costing methods being used were not applicable to other health systems, patients enrolled in the Military/VA system , an Health maintenance Organization (HMO) , or in Canada were excluded.||Per participant cost in US dollars||95% Confidence Interval|Mean
824481|NCT01174550|Secondary|Percentage of Invasive Cardiac Catheterization Events Without Obstructive Coronary Artery Disease Within 90 Days Following Participant Randomization|Percentage of Invasive Cardiac Catheterization Events Without Obstructive Coronary Artery Disease (CAD)Within 90 Days Following Participant Randomization|Up to 90 days following participant randomization|||Percentage of events||Standard Error|Mean
824482|NCT01174550|Secondary|Time to Death, Myocardial Infarction (MI), Unstable Angina (UA), Complications, No Coronary Artery Disease (CAD)|Time to primary endpoint as defined as a composite of death, myocardial infarction (MI), major complications from cardiovascular (CV) procedures or testing, unstable angina hospitalization, and no coronary artery disease (CAD). The Kaplan-Meier events rates (cumulative percentage of participants with an event) were estimated for the anatomic and functional diagnostic test groups.|90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months|||Percentage of participants with an event|||Number
824483|NCT01174550|Secondary|Time to Major Complications From Cardiovascular (CV) Procedures|Time to this secondary endpoint as defined as a composite of major complications from cardiovascular procedures and testing (stroke, bleeding, anaphylaxis, renal failure). The Kaplan-Meier events rates (cumulative percentage of participants with an event) were estimated for the anatomic and functional diagnostic test groups.|90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months|||Percentage of participants with an event|||Number
824484|NCT01174550|Secondary|Time to Death or Myocardial Infarction (MI)|Time to this secondary endpoint as defined as a composite of death and myocardial infarction (MI). The Kaplan-Meier events rates (cumulative percentage of participants with an event) were estimated for the anatomic and functional diagnostic test groups.|90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months|||Percentage of participants with an event|||Number
824485|NCT01174550|Secondary|Time to Death, Myocardial Infarction (MI), Unstable Angina Hospitalization|Time to this secondary endpoint as defined as a composite of death, myocardial infarction (MI), and unstable angina hospitalization. The Kaplan-Meier events rates (cumulative percentage of participants with an event) were estimated for the anatomic and functional diagnostic test groups.|90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months|||Percentage of participants with an event|||Number
824486|NCT01174550|Primary|Time to Primary Endpoint|Time to primary endpoint as defined as a composite of death, myocardial infarction (MI), major complications from cardiovascular (CV) procedures or testing, and unstable angina hospitalization. The Kaplan-Meier events rates (cumulative percentage of participants with an event) were estimated for the anatomic and functional diagnostic test groups.|90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months|||Percentage of participants with an event|||Number
824487|NCT01174576|Primary|Total Energy Intake|the energy consumed at breakfast, ad libitum meal and rest of the experimental day|1 d|||kcal||Standard Deviation|Mean
824489|NCT01174576|Primary|Cortisol Total Area Under the Curve|Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.|15 min before ingestion to 3 hr post ingestion|||ug*h/dL||Standard Deviation|Mean
824490|NCT01174576|Primary|Insulin Total Area Under the Curve|Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.|15 min before ingestion to 3 hr post ingestion|||uU*h/ml||Standard Deviation|Mean
824491|NCT01174576|Secondary|Serum Antioxidant Capacity Total Area Under the Curve|"Serum samples, collected 15 min before ingestion, immediately after ingestion, 15 min, 30 min, 60 min, 90 min, 120 min and 150 min after ingestion were analyzed for the ex vivo serum resistance to oxidative stress, that was induced by copper sulfate (CuSO4). The analysis of all collected samples was performed by the measurement of conjugated diene formation, which was monitored for every sample of all time points every 2 min for a 3.5 h period at 234 nm in a microplate spectrophotometer.
Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150 min postconsumption."|15 min before ingestion to 21/2 hr post ingestion|||lag time (min) *h||Standard Deviation|Mean
824492|NCT01174576|Primary|Glucose Total Area Under the Curve|Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.|15 min before ingestion to 3 hr post ingestion|||mg*h/dl||Standard Deviation|Mean
824493|NCT01174576|Primary|Interleukin-18 Total Area Under the Curve|Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.|15 min before ingestion to 3 hr post ingestion|||pg*h/mL||Standard Deviation|Mean
824494|NCT01174576|Primary|Inteleukin-6 Total Area Under the Curve|Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.|15 min before ingestion to 3 hr post ingestion|||pg*h/mL||Standard Deviation|Mean
824495|NCT01174576|Primary|Adiponectin Total Area Under the Curve|Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.|15 min before ingestion to 3 h post ingestion|||ug*h/mL||Standard Deviation|Mean
824496|NCT01174576|Primary|Glucagon-like Peptide-1 (GLP-1) Total Area Under the Curve|Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.|15 min before ingestion to 3 hr post ingestion|||ug*h/mL||Standard Deviation|Mean
824497|NCT01174576|Primary|Peptide Tyrosine Tyrosine (PYY) Total Area Under the Curve|Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.|15 min before ingestion to 3 hr post ingestion|||pg*h/mL||Standard Deviation|Mean
824498|NCT01174576|Primary|Ghrelin Total Area Under the Curve|Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.|15 min before ingestion to 3 hr post ingestion|||ug*h/mL||Standard Deviation|Mean
824499|NCT01174784|Primary|CTO Crossing Success Using the Wildcat|Successful femoropopliteal CTO crossing using the Wildcat identified by confirmation of guidewire placement in the distal true lumen confirmed by angiography.|Index through 30-Day Follow-Up|Patients treated with Wildcat post guidewire failure.||participants|||Number
824500|NCT01174784|Primary|Major Adverse Events|The primary safety endpoint of the CONNECT Study was defined as absence of in-hospital or 30-days Major Adverse Events (MAEs), no evidence of clinically significant perforations, clinically significant embolizations or Grade C or greater dissections after Wildcat CTO crossing confirmed by angiography.|Index through 30-Day Follow-Up|Patients treated with Wildcat post guidewire failure.||participants|||Number
824501|NCT01175005|Primary|Procalcitonin Level at ED Presentation|Level of procalcitonin will be obtained. At the end of the study we will determine who was septic or bacteremic and compare the procalcitonin levels between those who were septic/bacteremic and those who were not.We will attempt to identify whether a level of procalcitonin exists above which rates of bacteremia or bacterial sepsis in patients with fever and a central line exist. Blood cultures will be followed for up to 5 days until reported as final.There are no further study interventions.|Initial blood draw in ED and if admitted a second level will be obtained at 24 hours.|||ng/dL||95% Confidence Interval|Mean
824502|NCT01175018|Secondary|Number of Adverse Events Requiring Withdrawal in Each Group||10-14 weeks|||adverse events|||Number
824503|NCT01175018|Secondary|Number of Deaths in Each Group||10-14 weeks|||deaths|||Number
824504|NCT01175018|Secondary|Percentage of Patients in Each Group With Left Ventricular Ejection Fraction Change >10%||10-14 weeks|||% of participants|||Number
824505|NCT01175018|Secondary|Percentage of Patients in Each Group With Left Ventricular Ejection Fraction Change >5%||10-14 weeks|||% of participants|||Number
824506|NCT01175018|Secondary|Percentage of Patients in Each Group With Adverse Remodeling (LVESVi Increase >10%)||10-14 weeks|||% of participants|||Number
824507|NCT01175018|Secondary|Percentage of Patients in Each Group With Adverse Remodeling (LVESVi Increase >5%) Based Upon Cardiac Magnetic Resonance Imaging||10-14 weeks|Applies only to subset of patients with magnetic resonance imaging (MRI) at baseline and 10-14 weeks.||% of participants|||Number
824517|NCT01175018|Primary|Difference Between the Anakinra Arm and the Placebo Arm in Change in Left Ventricular End-systolic Volume Indices|Change in n left ventricular end-systolic volume indices from baseline to follow up exam at cardiac magnetic resonance imaging comparing anakinra- and placebo-treated patients.|10-14 weeks minus baseline|Applies only to subset of patients with magnetic resonance imaging (MRI) at baseline and 10-14 weeks.||mL/m2||Inter-Quartile Range|Median
824518|NCT01175031|Secondary|Device-Detected Clear Airway Apnea Agreement|Device Detected Clear Airways were broken down and then reviewed with the manually scored apneas. Of the clear airway apneas they were broken down into a few different categories: Manually Scored Obstructive Apneas, Manually Scored Central Apneas, Manually scored, hypopneas and manually scored RERAs.|During a single night of polysomnography lasting an average of 8 hours|335 Device Detected Clear Airway Apneas were detected.||events|Participants||Number
824519|NCT01175031|Secondary|Device-Detected Obstructed Airway Apnea Agreement|Device-Detected Apneas were broken down and then reviewed with the manually scored apneas. Of the Obstructed Airway apneas they were broken down into a few different categories: Manually Scored Obstructive Apneas, Manually Scored Central Apneas, Manually Scored Hypopneas and Manually Scored RERAs.|During a single night of polysomnography lasting an average of 8 hours|762 Device Detected Apneas were detected.||events|Participants||Number
824520|NCT01175031|Secondary|Device Detected Apneas as Detected by Philips Respironics (PR) System One|All device-detected apneas were tabulated. Then they were broken down into obstructed airway apneas and clear airway apneas. The results are recorded below as apneas with obstructed airway and apneas with clear airway.|During a single night of polysomnography lasting an average of 8 hours|1097 Device Detected Apneas were detected.||events|Participants||Number
824521|NCT01175031|Primary|Number of Breathing Events Identified by the Continuous Positive Airway Pressure (CPAP) Device Compared to a Simultaneous Polysomnography|The following breathing events: RERAs, central apneas, periodic breathing, obstructive apneas, and hypopneas in patients previously diagnosed with CompSAS or OSA detected by simultaneous Polysomnography and REMstar Auto with A-Flex were compared.|During a single night of polysomnography lasting an average of 8 hours|||events/hour||Standard Deviation|Mean
824522|NCT01181492|Secondary|PCA Fentanyl Consumption|PCA fentanyl consumption and adverse effects are recorded during the first 24 h after surgery.|24 h after surgery|||μg||Standard Deviation|Mean
824523|NCT01181492|Secondary|The Visual Analog Scale 24 Hours Postoperative|The visual analog scale (VAS) is used for pain evaluation at rest which from 0 to 10 (higher values represent morepain) during patient-controlled analgesia (PCA) treatment 24 h after operation|24 hours after operation|||units on a scale||Standard Deviation|Mean
824524|NCT01181492|Primary|CYP3A4*1G Polymorphism|According to CYP3A4*1G polymorphism,patients are devided into three groups: *1/*1,*1/*1G,*1G/*1G|48 hours after operation|the number of participants for analysis was determined according to gene type of CYP3A4*1G polymorphism which was carried by participant.||participants|||Number
824525|NCT01181531|Secondary|Treatment Comparison of Plasma PTH < 300 pg/mL During Efficacy Assessment Phase (EAP)|Number of participants achieving Plasma PTH < 300 pg/mL During Efficacy Assessment Phase (EAP)|week 40-52|||Participants|||Number
824526|NCT01181531|Secondary|Treatment Comparison of >=30% Reduction From Baseline in Mean PTH During the Efficacy Assessment Phase (EAP)|Number of participants achieving a >=30% Reduction From Baseline in Mean PTH During Efficacy Assessment Phase (EAP)|Baseline to week 40-52|||Participants|||Number
824527|NCT01181531|Primary|Percent Change From Baseline in Mean PTH During Efficacy Assessment Phase (EAP)|Mean PTH during EAP is defined as the mean of values at study weeks 40, 44, 48 and 52|Baseline to week 40-52|All subjects randomized by treatment arm.||Percent change||Standard Error|Least Squares Mean
824528|NCT01181609|Secondary|OS - Time to Event|OS was defined as the time from start of study treatment to death from any cause. Median OS was estimated using the Kaplan-Meier method.|Baseline, every cycle to progression or death. (Maximum of 52.5 months follow-up)|ITT population||months||95% Confidence Interval|Median
824529|NCT01181609|Secondary|Overall Survival (OS) - Percentage of Participants With an Event|Overall survival was defined as the time from start of study treatment to death from any cause.|Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up)|ITT population||percentage of participants|||Number
824530|NCT01181609|Secondary|Duration of Overall Disease Control|ODC duration was defined as the time in months, from when measurement criteria were first met for CR, PR, or SD (whichever status was recorded first) until the first date when progressive disease or the death from any cause was documented. Data were censored for participants who were lost to follow-up, discontinued prematurely without progression/death, or who reached the end of study without progression. Median ODC was estimated using the Kaplan-Meier method.|Baseline, every cycle until progression or death. (Maximum of 52.5 months follow-up)|ITT population; only participants with an ODC response (CR, PR, or SD) were included in the analysis.||months||95% Confidence Interval|Median
824531|NCT01181609|Secondary|Duration of Response|Duration of response was defined as the time in months from the day of CR or PR was first noted to the day of progression of disease, death or last follow-up. Median duraiton of response is estimated sing the Kaplan-Meier method.|Baseline, every cycle until progression or death (Maximum of 52.5 months follow-up)|ITT population; only participants with a response (CR or PR) were included in the analysis.||months||95% Confidence Interval|Median
824532|NCT01181609|Secondary|PFS - Time to Event|PFS was defined as the time from start of study treatment to investigator assessed disease progression, or death due to any cause, whichever comes first. Progression was based on tumor assessments made by the investigators according to RECIST. Median PFS was estimed using the Kaplan-Meier method.|Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up)|ITT population||months||95% Confidence Interval|Median
824533|NCT01181609|Secondary|Progression-Free Survival (PFS) - Percentage of Participants With an Event|PFS was defined as the time from start of study treatment to investigator assessed disease progression, or death due to any cause, whichever comes first. Progression was based on tumor assessments made by the investigators according to RECIST.|Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up)|ITT||percentage of participants|||Number
824561|NCT01182428|Secondary|Persisting Dissection|All subjects with persisting dissection of the target lesion up to the 270 day follow-up visit|at 270 days|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.||Percentage of evaluated lesions|Participants|95% Confidence Interval|Number
824534|NCT01181609|Secondary|Percentage of Participants Achieving a Best Overall Response of CR or PR|Percentage of participants achieving CR or PR as defined by RECIST criteria. CR defined as disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR was defined as ≥30% decrease under baseline of the sum of the LD of all target lesions. CR and PR were confirmed no less than 4 weeks after the criteria for response were met.|Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up)|ITT population||percentage of participants||95% Confidence Interval|Number
824535|NCT01181609|Primary|Percentage of Participants Achieving Overall Disease Control (ODC)|ODC was defined as the percentage of participants with measurable disease at baseline who on assessment achieved complete response (CR), partial response (PR), or stable disease (SD) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR was defined as greater than or equal to (≥) 30 percent (%) decrease under baseline of the sum of the longest diameter (LD) of all target lesions. SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD since start of treatment. CR and PR were confirmed no less than 4 weeks after the criteria for response were met.|Baseline, after every other cycle to disease progression or death (Maximum of 52.5 months follow-up)|ITT population||percentage of participants||95% Confidence Interval|Number
824536|NCT01182194|Primary|AUC0-inf of Ethinyl Estradiol(Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on Ethinyl Estradiol AUC0-inf.|Blood samples collected over a 72 hour period.|Analysis included 29 of 31 finished subjects. Subject 13 was excluded from the analysis population due to pre-dose levels greater than 5% for Cmax in Period 1 and Period 2. Subject 31 was excluded from the analysis population due to pre-dose levels greater than 5% for Cmax in Period 1.||pg*h/mL||Standard Deviation|Mean
824537|NCT01182194|Primary|AUC0-t of Ethinyl Estradiol(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on Ethinyl Estradiol AUC0-t.|Blood samples collected over a 72 hour period.|Analysis included 29 of 31 finished subjects. Subject 13 was excluded from the analysis population due to pre-dose levels greater than 5% for Cmax in Period 1 and Period 2. Subject 31 was excluded from the analysis population due to pre-dose levels greater than 5% for Cmax in Period 1.||pg*h/mL||Standard Deviation|Mean
824538|NCT01182194|Primary|Cmax of Ethinyl Estradiol(Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Ethinyl Estradiol Cmax.|Blood samples collected over a 72 hour period.|Analysis included 29 of 31 finished subjects. Subject 13 was excluded from the analysis population due to pre-dose levels greater than 5% for Cmax in Period 1 and Period 2. Subject 31 was excluded from the analysis population due to pre-dose levels greater than 5% for Cmax in Period 1.||pg/mL||Standard Deviation|Mean
824539|NCT01182194|Primary|AUC0-inf of Drospirenone(Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on Drospirenone AUC0-inf.|Blood samples collected over a 120 hour period.|Analysis included 30 of 31 finished subjects. Subject 31 was excluded from the analysis population due to pre-dose levels greater than 5% for Cmax in Period 1.||ng*h/mL||Standard Deviation|Mean
824540|NCT01182194|Primary|AUC0-t of Drospirenone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on Drospirenone AUC0-t.|Blood samples collected over a 120 hour period.|Analysis included 30 of 31 finished subjects. Subject 31 was excluded from the analysis population due to pre-dose levels greater than 5% for Cmax in Period 1.||ng*h/mL||Standard Deviation|Mean
824541|NCT01182194|Primary|Cmax of Drospirenone(Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Drospirenone Cmax.|Blood samples collected over a 120 hour period.|Analysis included 30 of 31 finished subjects. Subject 31 was excluded from the analysis population due to pre-dose levels greater than 5% for Cmax in Period 1.||ng/mL||Standard Deviation|Mean
824542|NCT01182207|Primary|AUC0-inf of Ethinyl Estradiol(Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on Ethinyl Estradiol AUC0-inf.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
824543|NCT01182207|Primary|AUC0-t of Ethinyl Estradiol(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on Ethinyl Estradiol AUC0-t.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
824544|NCT01182207|Primary|Cmax of Ethinyl Estradiol(Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Ethinyl Estradiol Cmax.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg/mL||Standard Deviation|Mean
824545|NCT01182207|Primary|AUC0-inf of Drospirenone(Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on Drospirenone AUC0-inf.|Blood samples collected over a 120 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
824546|NCT01182207|Primary|AUC0-t of Drospirenone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on Drospirenone AUC0-t.|Blood samples collected over a 120 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
824547|NCT01182207|Primary|Cmax of Drospirenone(Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Drospirenone Cmax.|Blood samples collected over a 120 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
824548|NCT01182285|Secondary|NIS (Na/I-symporter) Expression|NIS (Na/I-symporter) Expression is assessed by quantitative reverse transcription (RT) polymerase chain reaction (PCR) and immunohistochemistry (IHC). NIS mRNA expression was measured by quantitative RT PCR from biopsy samples.|Entry to study and after 10 weeks of treatment|There is no standard of error to report. The acronym GAPDH expanded is glyceraldehyde 3-phosphate dehydrogenase. Only 1 participant was analyzed because biopsies were not performed in 12 subjects.||percent expression||Standard Error|Median
824562|NCT01182428|Secondary|Thrombus|All subjects with thrombus of the target lesion up to the 270 day follow-up visit|at 270 days|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.||Percentage of evaluated lesions|Participants|95% Confidence Interval|Number
824549|NCT01182285|Secondary|Best Overall Response|Best overall response was assessed by radioiodine uptake. Complete response (CR) is increased Rai (radioiodine) uptake on post- valproic acid therapy at week 10, AND a decrease in Tg (thyroglobulin ) level to less than 2 ng/ml (or a decrease in Tg-Ab (thyroglobulin antibodies) level to less than 2.0 IU/ml) at 10 weeks AND disappearance of all lesions at 16 weeks. Partial response (PR) is increased Rai uptake on post-valproic scan at week 10, OR a decreased Tg level (or a decrease in Tg Ab (Tg antibody) level by more than 20%) at 10 weeks AND 30% decrease in target lesion at 16 weeks. Stable disease (SD) is no change in RAI uptake AND Tg levels (or TG-Ab level) AND no significant change of lesions at 16 weeks. Progressive disease (PD) is tumor mass increases OR Tg levels (or Tg-Ab levels) increases over 10 weeks OR at least 20% increase in target lesion at 16 weeks.|Week 16|Best overall response was not assessed for the phase 1 portion.||participants|||Number
824550|NCT01182285|Primary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|41 months and 11 days|Adverse events are not reported per Arm. All adverse events were reported to include phases 1 and 2 since it is analyzed throughout the whole study.||participants|||Number
824551|NCT01182285|Primary|RAI (Radioactive Iodine) Uptake and Tg (Thyroglobulin) Level Compared Pre and Post- Valproic Treatment|Complete response (CR) is increased Rai uptake on post- valproic acid therapy at week 10, AND a decrease in Tg level to less than 2 ng/ml (or a decrease in Tg-Ab level to less than 2.0 IU/ml) at 10 weeks AND disappearance of all lesions at 16 weeks. Partial response (PR) is increased Rai uptake on post-valproic scan at week 10, OR a decreased Tg level (or a decrease in Tg Ab (Tg antibody) level by more than 20%) at 10 weeks AND 30% decrease in target lesion at 16 weeks. Stable disease (SD) is no change in RAI uptake AND Tg levels (or TG-Ab level) AND no significant change of lesions at 16 weeks. Progressive disease (PD) is tumor mass increases OR Tg levels (or Tg-Ab levels) increases over 10 weeks OR at least 20% increase in target lesion at 16 weeks.|Entry to study and after 10 weeks of treatment for Phase 1, and 10 weeks of treatment to 16 weeks of treatment for phase 2.|13 participants were enrolled in phase 1 and 8/13 (5 from University of California San Francisco (UCSF) moved on from phase 1 to the phase 2 schedule 2 portion. However, Tg data from UCSF is unavailable for 5 of the participant, thus only 3 were analyzed in the phase 2 portion.||participants|||Number
824552|NCT01182298|Primary|Median Log Change in HCV RNA Levels on Day 7|The primary end point of this study is the the log change in HCV RNA levels on Day 7|first 7 days|||log IU/mL||Inter-Quartile Range|Median
824553|NCT01182337|Secondary|Change in Mental Component Summary Quality of Life Measure Assessed by Short Form SF-36 at 12 Months From Baseline.|The 36-item Short Form Health Survey (SF-36) is a patient reported outcome survey that evaluates functional health and well-being. The survey is converted into two summary measures (the Physical Component - PCS and Mental Component- MCS) that are scored from 0 to 100 (where 100 indicates the highest level of health).|12 Months|"FAS Population
Only 21 subjects from the rhGDF-5 group (out of 22 subjects total) completed the MCS, SF-36."||units on a scale||Standard Deviation|Mean
824554|NCT01182337|Secondary|Change in Physical Component Summary of Quality of Life Measure Assessed by Short Form 36 at 12 Months From Baseline|The 36-item Short Form Health Survey (SF-36) is a patient reported outcome survey that evaluates functional health and well-being. The survey is converted into two summary measures (the Physical Component - PCS and Mental Component- MCS) that are scored from 0 to 100 (where 100 indicates the highest level of health).|12 months|"FAS Population
Only 21 subjects from the rhGDF-5 group (out of 22 total subjects) completed the baseline PCS, SF-36."||units on a scale||Standard Deviation|Mean
824555|NCT01182337|Secondary|Change in Pain Visual Analog Scale (VAS) at 12 Months From Baseline.|The Visual Analog Scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line (that is approximately 10 cm long) with 'No Pain' (score of 0 = 0 cm) listed on the left and 'Very severe pain' (score of 10=10cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their back.|12 months|FAS Population||units on a scale||Standard Deviation|Mean
824556|NCT01182337|Primary|Treatment Emergent Adverse Events- Relationship to Study Drug|Number of patients with Treatment Emergent Adverse Events that were designated as Possibly or Probably Related to Study Drug.|12 month period and annual telephone contact at 24 and 36 months for subject health status follow-up|Safety Population||participants|||Number
824557|NCT01182337|Primary|Treatment Emergent Adverse Events- Relationship to Study Drug|Number of patients with Treatment Emergent Adverse Events that were designated as Definitely Related to Study Drug.|Through a 12 month period and annual telephone contact at 24 and 36 months for subject health status follow-up|Safety Population||participants|||Number
824558|NCT01182337|Secondary|Change in Function Assessed by Oswestry Disability Index Change at 12 Months From Baseline.|The Oswestry Disability Index (ODI) is a 10-category (Pain Intensity, Personal Care, Lifting, Walking, Sitting, Standing, Sleeping, Sex Life, Social Life, Traveling) disability measurement scale with a graded response from 0 to 5, with 0 being the best score (no impairment) to 5 being the worst score (significant impairment). ODI score for a subject is calculated by adding the scores and converting the score to a 100 point scale.|12 month|FAS Population||units on a scale||Standard Deviation|Mean
824559|NCT01182337|Primary|Neurological Assessment for Motor Function and Reflexes/Sensory|"Neurological Assessment for Motor Function and Reflexes/Sensory- Number of patients with Clinically Significant Abnormal results at 12 months.
For Motor Function, Clinically Significant Abnormal results are determined by the surgeon investigator and are further classified by grade: 0= No Movement, 1= Flicker/trace of contraction, 2=Active movement when gravity removed, 3= Active movement against gravity, 4= Active Movement against gravity and resistance.
For Reflexes/Sensory, Clinically Significant Abnormal results are determined by the surgeon investigator and are based on exams of the Knee, Ankle, L3-L5 Dermatone, and S1 Dermatome. Tension signs are evaluated with a straight leg raise to determine at which point, if any, sciatic pain occurs."|12 months|"Safety Population
For the Neurological Assessment at 12 months, only 21 subjects from the rhGDF-5 group completed the assessment (out of 22 total subjects) and 5 subjects from the Control group completed the assessment (out of 9 subjects total)."||participants|||Number
824560|NCT01182376|Primary|LA Fibrosis|The change in left atrial fibrosis percentage, as measured on a scale, using MRI imaging, from baseline to the end of treatment.|baseline, 1 year|The number of participants analyzed for both groups is less than the number enrolled due to patient attrition or poor MRI scans.||percentage of fibrosis||Standard Deviation|Mean
824563|NCT01182428|Secondary|Aneurysm|All subjects with aneurysm of the target lesion up to the 270 day follow-up visit|at 270 days|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.||% of target lesions with aneurysm|Participants|95% Confidence Interval|Number
824564|NCT01182428|Secondary|Adjudicated Revascularization (TLR/TVR/All Revascularizations)|Composite of Target Lesion Revascularization (TLR), Target Vessel Revascularization (TVR), all revascularizations|at 1 year|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.||Percentage of Participants||95% Confidence Interval|Number
824565|NCT01182428|Secondary|Adjudicated Revascularization (TLR/TVR/All Revascularizations)|Composite of Target Lesion Revascularization (TLR), Target Vessel Revascularization (TVR), all revascularizations|at 240 days|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.||Percentage of Participants||95% Confidence Interval|Number
824566|NCT01182428|Secondary|Adjudicated Revascularization (TLR/TVR/All Revascularizations)|Composite of Target Lesion Revascularization (TLR), Target Vessel Revascularization (TVR), all revascularizations|at 30 days|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.||Percentage of Participants||95% Confidence Interval|Number
824567|NCT01182428|Secondary|In-segment Percent Diameter Stenosis||at 270 days|The angiographic analysis population is less than the total population for the following reasons: Refusals, Death, Test Not Analyzable, Scheduling Problems, Medical Decisions, No study stent implanted, Patient Misunderstandings, Patient withdrawn by physician, Consent Withdrawal.||% diameter stenosis|Participants|Standard Deviation|Mean
824568|NCT01182428|Secondary|In-stent Percent Diameter Stenosis||at 270 days|The angiographic analysis population is less than the total population for the following reasons: Refusals, Death, Test Not Analyzable, Scheduling Problems, Medical Decisions, No study stent implanted, Patient Misunderstandings, Patient withdrawn by physician, Consent Withdrawal.||% diameter stenosis|Participants|Standard Deviation|Mean
824569|NCT01182428|Secondary|In-segment Angiographic Binary Restenosis Rates|Only a certain number of patients were required to have angiographic follow-up. Percent of subjects with a follow-up in-stent percent diameter stenosis of ≥ 50% per quantitative coronary angiography (QCA).|at 270 days|The angiographic analysis population is less than the total population for the following reasons: Refusals, Death, Test Not Analyzable, Scheduling Problems, Medical Decisions, No study stent implanted, Patient Misunderstandings, Patient withdrawn by physician, Consent Withdrawal.||Percentage of target lesions|Participants|95% Confidence Interval|Number
824570|NCT01182428|Secondary|In-stent Angiographic Binary Restenosis Rates|Only a certain number of patients were required to have angiographic follow-up. Percent of subjects with a follow-up in-stent percent diameter stenosis of ≥ 50% per quantitative coronary angiography (QCA).|at 270 days|The angiographic analysis population is less than the total population for the following reasons: Refusals, Death, Test Not Analyzable, Scheduling Problems, Medical Decisions, No study stent implanted, Patient Misunderstandings, Patient withdrawn by physician, Consent Withdrawal.||Percentage of Target Lesions|Participants|95% Confidence Interval|Number
824571|NCT01182428|Secondary|In-segment Late Loss (LL)|LL = Minimal Lumen Diameter (MLD) post-procedure minus MLD at follow-up|at 270 days|The angiographic analysis population may be less than the total population for the following reasons: Refusals, Death, Test Not Analyzable, Scheduling Problems, Medical Decisions, No study stent implanted, Patient Misunderstandings, Patient withdrawn by physician, Consent Withdrawal.||millimeters|Participants|Standard Deviation|Mean
824572|NCT01182428|Secondary|Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).||at 1 year|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.||Percentage of Participants||95% Confidence Interval|Number
824573|NCT01182428|Secondary|Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).||at 240 days|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.||Percentage of Participants||95% Confidence Interval|Number
824574|NCT01182428|Secondary|Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).||at 30 days|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.||Percentage of Participants||95% Confidence Interval|Number
824575|NCT01182428|Secondary|Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR).||at 1 year|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.||Percentage of Participants||95% Confidence Interval|Number
824576|NCT01182428|Secondary|Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR).||at 240 days|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.||Percentage of Participants||95% Confidence Interval|Number
824577|NCT01182428|Secondary|Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR).||at 30 days|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.||Percentage of Participants||95% Confidence Interval|Number
824578|NCT01182428|Primary|In-stent Late Loss (LL) (Main Secondary Endpoint)|In-stent Minimal Lumen Diameter (MLD)post-procedure – in-stent MLD at follow-up.|at 270 days|The angiographic analysis population may be than the total population for the following reasons: Refusals, Death, Test Not Analyzable, Scheduling Problems, Medical Decisions, No study stent implanted, Patient Misunderstandings, Patient withdrawn by physician, Consent Withdrawal.||millimeters|Participants|Standard Deviation|Mean
824579|NCT01182428|Secondary|Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR).||at 240 days|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.||Percentage of Participants||95% Confidence Interval|Number
824580|NCT01182428|Secondary|Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR).||at 30 days|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.||Percentage of Participants||95% Confidence Interval|Number
824581|NCT01182428|Secondary|Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and CI-TLR.||at 1 year|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.||Percentage of Participants||95% Confidence Interval|Number
824582|NCT01182428|Secondary|Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and CI-TLR.||at 240 days|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.||Percentage of Participants||95% Confidence Interval|Number
824583|NCT01182428|Secondary|Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and Clinically Indicated Target Lesion Revascularization (CI-TLR).||at 30 days|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.||Percentage of Participants||95% Confidence Interval|Number
824584|NCT01182428|Secondary|Adjudicated Stent Thrombosis (Definite, Probable, Possible)||30 days to 1 year (Late)|Based on Intent to Treat (ITT) population.||Percentage of Participants||95% Confidence Interval|Number
824585|NCT01182428|Secondary|Adjudicated Stent Thrombosis (Definite, Probable)||30 days to 1 year (Late)|Based on Intent to Treat (ITT) population. Population change based on follow up timeframe.||Percentage of Participants||95% Confidence Interval|Number
824586|NCT01182428|Secondary|Adjudicated Stent Thrombosis (Definite, Probable)||1 to 30 days (Sub-Acute)|Based on Intent to Treat (ITT) population.||Percentage of Participants||95% Confidence Interval|Number
824587|NCT01182428|Secondary|Adjudicated Stent Thrombosis (Definite, Probable)||< 1 day (Acute)|Based on Intent to Treat (ITT) population.||Percentage of Participants||95% Confidence Interval|Number
824588|NCT01182428|Secondary|Clinical Procedure Success|Successful delivery and deployment of the study stent or stents at the intended target lesion and successful withdrawal of the stent delivery system without adverse cardiac events.|Intra-operative|Based on Intent to Treat (ITT) population.||Percentage of Participants||95% Confidence Interval|Number
824589|NCT01182428|Secondary|Clinical Device Success|Successful delivery and deployment of the study stent at the intended target lesion and successful withdrawal of the stent delivery system.|Intra-operative|Based on Intent to Treat (ITT) population.||Percentage of evaluated lesions|Participants|95% Confidence Interval|Number
824590|NCT01182428|Primary|Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR).|This measure adds together all subjects who were determined by an expert panel to have died, had MI or had TVR as a result of their procedure.|at 1 year|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.||Percentage of Participants||95% Confidence Interval|Number
824591|NCT01182480|Secondary|Glycemic Control|Measured by patients' self-reported fasting blood glucose levels during the intervention period and compared to previous laboratory data in the medical record.|3 months||||||
824592|NCT01182480|Secondary|Perceived Self-efficacy|As measured by comparison of patient responses to validated assessment instrument administered at baseline and post-intervention|3 months||||||
824593|NCT01182480|Secondary|Appointment Attendance|As measured by no-show rates for appointments at all clinics during the study period, compared between intervention and control groups|3 months||||||
824594|NCT01182480|Primary|Patient Engagement|Patient engagement was assessed by patient text message response rates and average response times. Response rates were calculated as a percentage from the number of patient-initiated text messages sent in response to a system-generated request for information (the numerator) divided by the total number of system-generated requests for information (the denominator). Average response times were calculated from system-recorded time stamps for outbound requests sent and inbound patient-initiated responses received.|3 months|Group of study participants who received the text message intervention over a 3-month period.||text message response rate (percent)|||Number
824595|NCT01182493|Secondary|Change in Body Weight or BMI, Lipids and Blood Pressure||6 months||||||
824596|NCT01182493|Secondary|Quality of Life and Treatment Satisfaction||6 months||||||
824597|NCT01182493|Secondary|Change in Postprandial Glycemia|Change in mean postprandial hyperglycemia 0 to 2 hours post meal, defined as ≥180 mg/dl and measured by SMBG|6 months||||||
824598|NCT01182493|Secondary|Safety|Severe hypoglycemia incidence; Diabetic Ketoacidosis incidence and Diabetes related hospitalizations|6 months treatment and 6 months follow-up||||||
824599|NCT01182493|Secondary|Change in Glycemic Variability|Glycemic parameters calculated from blinded CGM data: Measure of the Average glucose/day; AUC in hypo- (≤70mg/dL) and in hyperglycemia (≥180 mg/dL; Time spent in hypo- (≤70mg/dL) and hyperglycemia (≥180 mg/dL); Mean Amplitude of Glycemic Excursions (MAGE) is the most common measure of the volatility of blood glucose levels; Standard deviation|6 months||||||
824600|NCT01182493|Primary|Between Group Difference in HbA1c When Comparing CSII to MDI|To evaluate change in glycemic control (HbA1c) after 6 months of insulin pump therapy in patients with type 2 DM, as compared to patients on MDI therapy over the same time period|6 months|||% HbA1c||Standard Deviation|Mean
824601|NCT01182610|Secondary|Survival||2-year survival from first dose of panitumumab|This study was closed due to a notification letter (November 1, 2011) and preliminary results from another trial that included panitumumab as part of combination chemotherapy for gastroesophageal cancer. The study was closed by mutual consent from the Principal Investigator, Sponsor, and Funder.|||||
824602|NCT01182610|Secondary|Thirty-day Surgical Mortality|All subjects who have undergone surgical resection will be followed for a 30-day postoperative safety evaluation. Death from any cause within 30 days of the date of surgery will be considered a surgical mortality death.|From date of surgery to 30 days after date of surgery|This study was closed due to a notification letter (November 1, 2011) and preliminary results from another trial that included panitumumab as part of combination chemotherapy for gastroesophageal cancer. The study was closed by mutual consent from the Principal Investigator, Sponsor, and Funder.|||||
824603|NCT01182610|Secondary|Resection Rate of Surgery|"The patient will be scored as having an R0 resection, if no invasive cancer is detected involving the margins of the resection by routine microscopic hematoxylin and eosin (H&E)examination, and the operative report indicates complete resection with no residual disease.
The patient will be scored as having an R1 resection, if invasive cancer is detected involving the margins of resection by routine microscopic hematoxylin and eosin (H&E) examination, and the operative report indicates complete resection with no residual disease.
The patient will be scored as having an R2 resection, if the operative report indicates incomplete resection or gross residual disease."|At time of surgery (between days 50 to 64)|This study was closed due to a notification letter (November 1, 2011) and preliminary results from another trial that included panitumumab as part of combination chemotherapy for gastroesophageal cancer. The study was closed by mutual consent from the Principal Investigator, Sponsor, and Funder.|||||
824604|NCT01182610|Secondary|Pathologic Response Rate|The patient will be scored as having had a pathologic complete response (pCR) if the routine histologic examination of the resected specimen shows no residual invasive cancer by standard hematoxylin and eosin (H&E) examination.|At time of surgery (between days 50 to 64)|This study was closed due to a notification letter (November 1, 2011) and preliminary results from another trial that included panitumumab as part of combination chemotherapy for gastroesophageal cancer. The study was closed by mutual consent from the Principal Investigator, Sponsor, and Funder.|||||
824605|NCT01182610|Primary|Response Rate|The primary endpoint is overall response rate (ORR) as determined per RECIST guidelines version 1.1 from baseline and restaging scans conducted between Days 36 to 43. Response is defined as the occurrence of either Complete Response (CR) or Partial Response (PR) as best response. CR is defined as the disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. A PR is defined as at least a 30% decrease in the sum of diameters of the target lesions taking as reference the baseline sum diameters.|From the start of study treatment until restaging evaluation performed between days 36 to 43|This study was closed due to a notification letter (November 1, 2011) and preliminary results from another trial that included panitumumab as part of combination chemotherapy for gastroesophageal cancer. The study was closed by mutual consent from the Principal Investigator, Sponsor, and Funder.|||||
824606|NCT01182675|Secondary|Percent Engraftment of Donor T-cells in Blood by STR Testing|We will measure whether we are able to detect donor T-cells in the patient's blood after HSCT.|1 Year||||||
824607|NCT01182675|Secondary|Percent Engraftment of Donor Stem Cells in Bone Marrow by STR Testing|We will measure whether we are able to detect donor stem cells in the patient's bone marrow after HSCT.|1 Year||||||
824608|NCT01182675|Secondary|Percentage of Patients Who Become Independent From Regular IVIG Infusion|Based on B-cell function assays from the patient's blood, we will be able to determine if patients are able to successfully discontinue IVIG infusions.|2 Years||||||
824609|NCT01182675|Secondary|Incidence of Chronic GVHD||2 Years||||||
824610|NCT01182675|Secondary|Incidence of Acute GVHD||100 Days||||||
824611|NCT01182675|Primary|Engraftment of Donor B-cells in Blood by STR Testing|Number of participants in whom donor B cells were detected in the patient's blood after HSCT.|1 Year|||participants|||Number
824612|NCT01182727|Primary|Side Effects of Salsalate|This Measure is reporting the number of participants with side effects as reported on the Side Effect Checklist used to monitor common medication side effects.|6 weeks|All subjects who completed the study were analyzed.||participants|||Number
824613|NCT01182805|Primary|Early Diastolic Mitral Annular Velocity (E-prime) Using Tissue Doppler|E-prime is a conventional commonly-used parameter of diastolic function. Higher values of E-prime typically reflect better diastolic function.|Assessed from echo obtained at time of enrollment|Only 25 subjects had adequate images for assessment of DCSR-IVR and interpretable tissue Doppler and gold standard assessment of diastolic function, and the analysis was limited to these subjects.||cm/sec||Standard Deviation|Mean
824614|NCT01182805|Primary|Diastolic Circumferential Strain Rate During Isovolumic Relaxation|Diastolic circumferential strain rate during isovolumic relaxation is a novel measure of diastolic function that measures the rate of relaxation of the left ventricle during the interval of isovolumic relaxation (the period of active relaxation). We would expect that a higher value reflects better relaxation, and better diastolic function.|Assessed from echo obtained at time of enrollment|Only 26 subjects had adequate images for assessment of DCSR-IVR and had gold standard assessment of diastolic function, and the analysis was limited to these subjects.||1/sec||Standard Deviation|Mean
824615|NCT01183013|Secondary|Incidence of Rescue Therapy During the First 30 Weeks of Treatment|Rescue therapy was defined to include any new antidiabetic medication taken for hyperglycemia and introduced on or after the start date of study treatment and before the end date of study treatment.|30 weeks|FAS||participants|||Number
824616|NCT01183013|Secondary|Time to First Use of Rescue Therapy|Proportion of patients at 30 weeks with rescue therapy using Kaplan-Meier analysis.|30 weeks|FAS||Proportion of participants|||Number
824617|NCT01183013|Secondary|Two-hour Postprandial Glucose (2hPPG) Change From Baseline at Week 30 by Meal Tolerance Test (MTT)|The change from baseline is the 2hPPG after 30 weeks minus the baseline 2hPPG.|Baseline and 30 weeks|MTT set: This patient set includes those patients in the FAS who had a valid MTT at baseline and at least one valid on-treatment MTT. An MTT is considered valid if both an FPG and a 2-hour PPG value are available.||mg/dL||Standard Error|Least Squares Mean
824618|NCT01183013|Secondary|Fasting Plasma Glucose (FPG) Change From Baseline by Visit Over Time|The change from baseline is the FPG over time minus the baseline FPG. Model includes fixed effects for treatment, continuous baseline FPG, continuous baseline HbA1c, prior anti-diabetic medication, country, visit and treatment by visit interaction|Baseline, week 6, week 12, week 18, week 24, week 30|FAS (observed cases)||mg/dL||Standard Error|Mean
824619|NCT01183013|Secondary|Fasting Plasma Glucose (FPG) Change From Baseline After 30 Weeks of Treatment|The change from baseline is the FPG after 30 weeks minus the baseline FPG.|Baseline and 30 weeks|Patients from Full Analysis Set (FAS) with a value for FPG at baseline and on-treatment. Last observation carried forward (LOCF) used to handle missing values at Week 30.||mg/dL||Standard Error|Mean
824620|NCT01183013|Secondary|HbA1c Change From Baseline by Visit Over Time|"HbA1c is measured as a percentage. The change from baseline is the HbA1c over time minus the baseline HbA1c. The model includes fixed effects for treatment, continuous baseline HbA1c, prior andi-diabetic medication, country, visit and treatment.
by visit interaction."|Baseline, week 6, week 12, week 18, week 24, week 30|FAS (observed cases)||percent||Standard Error|Mean
824622|NCT01183013|Secondary|Occurrence of Cumulative Treat to Target Efficacy Response, of HbA1c Under Treatment of < 6.5% After 30 Weeks of Treatment|Glycosylated hemoglobin is reported as a percentage of the total hemoglobin.|Baseline and 30 weeks|FAS patients who also had baseline HbA1c >=6.5%. Non-completers (patients without a value at Week 30) were considered as failures (NCF)||participants|||Number
824623|NCT01183013|Secondary|Occurrence of Cumulative Treat to Target Efficacy Response, of HbA1c Under Treatment of < 7.0% After 30 Weeks of Treatment|Glycosylated hemoglobin is reported as a percentage of the total hemoglobin.|Baseline and 30 weeks|FAS patients who also had baseline HbA1c>=7%.Non-completers (patients without a value at Week 30) were considered as failures (NCF).||participants|||Number
824624|NCT01183013|Primary|Change From Baseline in HbA1c After 30 Weeks of Treatment.|HbA1c is measured as a percentage. The change from baseline is the Week 30 HbA1c minus the baseline HbA1c.|Baseline and 30 weeks|Patients from Full Analysis Set (FAS) with last observation carried forward (LOCF) used to handle missing values at Week 30. FAS is the patient set which includes all patients who were documented to have taken at least one dose of treatment and who had a baseline HbA1c value at at least one on-treatment HbA1c.||percent||Standard Error|Mean
824625|NCT01183065|Primary|To Determine the Overall Response Rate (CR+PR)|by RECIST version 1.1 criteria|2 years|||participants|||Number
824626|NCT01183104|Secondary|Change From Baseline in Body Weight at 52 W||Baseline and 52 W|Analysis set of evaluation for efficacy; Per Protocol Set. Some participants had loss of the measurement.||kg||Standard Deviation|Mean
824627|NCT01183104|Secondary|Change From Baseline in Insulin/Proinsulin Ratio at 52 W||Baseline and 52 W|Analysis set of evaluation for efficacy; Per Protocol Set. Some participants had loss of the measurement.||ratio||Standard Deviation|Mean
824628|NCT01183104|Secondary|Change From Baseline in HOMA-β at 52 W|β cell function is measured by the Homeostatic Model Assessment(HOMA-β). HOMA β = [20 x fasting insulin (μU/mL)] / [fasting plasma glucose (mmol/L) - 3.5]|Baseline and 52 W|Analysis set of evaluation for efficacy; Per Protocol Set. Some participants had loss of the measurement.||percent||Standard Deviation|Mean
824629|NCT01183104|Secondary|The Number of Participants Achieving HbA1c < 6.9 %||52 W|Analysis set of evaluation for efficacy; Per Protocol Set Some participants were not completed to 52 W.||Participants|||Count of Participants
824630|NCT01183104|Primary|Number of Participants With Hypoglycaemia||From baseline to 52 W|Analysis set of evaluation for safety.||Participants|||Count of Participants
824631|NCT01183104|Primary|Change From Baseline in HbA1c at 52 W||Baseline and 52 W|Analysis set of evaluation for efficacy; Per Protocol Set.||percent||95% Confidence Interval|Least Squares Mean
824632|NCT01183169|Secondary|Percentage of Participants With Viral Relapse|Viral relapse was defined as reappearance of detectable HCV RNA after previously being undetectable (< LOQ) during treatment.|within 24 weeks after treatment|FAS For Efficacy||percentage of participants|||Number
824633|NCT01183169|Secondary|Percentage of Participants With On-treatment Viral Breakthrough|"On-treatment viral breakthrough was defined as either:
Confirmed increase of HCV RNA ≥1 log10 above nadir (nadir = lowest HCV RNA value during treatment), or
HCV RNA becoming ≥ 100 IU/mL after previously being undetectable (< LOQ) during treatment"|within 48 weeks|FAS For Efficacy||percentage of participants|||Number
824634|NCT01183169|Secondary|Percentage of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Had Normalized ALT at Treatment End and Study End||Up to 48 weeks|Participants in the FAS For Efficacy with abnormal ALT at baseline and available data at the respective time point||percentage of participants|||Number
824635|NCT01183169|Secondary|Percentage of Participants With End of Treatment Response (ETR)-LOQ and ETR-LOD|ETR-LOQ and ETR-LOD were defined as serum HCV RNA < LOQ and serum HCV RNA < LOD at treatment end (completed or prematurely discontinued), respectively.|within 48 weeks|FAS For Efficacy||percentage of participants|||Number
824636|NCT01183169|Secondary|Percentage of Participants With Partial Early Virologic Response After 12 Weeks of Treatment (pEVR)-LOQ and pEVR-LOD|pEVR-LOQ and pEVR-LOD were defined as a ≥ 2 log10 decrease in HCV RNA and still detectable (≥ LOQ and ≥ LOD, respectively) after 12 weeks of treatment. Post-switch groups were assessed 12 weeks after the switch.|after 12 weeks of treatment|FAS For Efficacy||percentage of participants|||Number
824637|NCT01183169|Secondary|Percentage of Participants With Rapid Viral Response (RVR)-LOQ and RVR-LOD|RVR-LOQ and RVR-LOD were defined as serum HCV RNA < LOQ and serum HCV RNA < LOD after 4 weeks of treatment, respectively. Post-switch groups were assessed 4 weeks after the switch.|after 4 weeks of treatment|FAS For Efficacy||percentage of participants|||Number
824638|NCT01183169|Secondary|Percentage of Participants Who Achieved Sustained Viral Response 24 Weeks After Treatment (SVR24)-LOQ and SVR24-LOD|SVR24-LOQ and SVR24-LOD were defined as serum HCV RNA < LOQ and serum HCV RNA < LOD 24 weeks after treatment, respectively.|24 weeks after treatment|FAS For Efficacy||percentage of participants|||Number
824639|NCT01183169|Secondary|Percentage of Participants Who Achieved Sustained Viral Response 12 Weeks After Treatment (SVR12)-LOQ and SVR12-LOD|SVR12-LOQ and SVR12-LOD were defined as serum HCV RNA < LOQ and serum HCV RNA < LOD 12 weeks after treatment, respectively.|12 weeks after treatment|FAS For Efficacy||percentage of participants|||Number
824640|NCT01183169|Secondary|Percentage of Participants With Complete Early Viral Response Below the Limit of Detection (cEVR-LOD)|cEVR-LOD was defined as serum HCV RNA below the limit of detection (< LOD; i.e., 10 IU/mL) after 12 weeks of treatment. Post-switch groups were assessed 12 weeks after the switch.|after 12 weeks of treatment|FAS For Efficacy||percentage of participants|||Number
824641|NCT01183169|Primary|Percentage of Participants With Complete Early Viral Response Below the Limit of Quantification (cEVR-LOQ)|cEVR-LOQ was defined as serum HCV RNA below the limit of quantification (< LOQ; i.e., 25 IU/mL) after 12 weeks of treatment. Post-switch groups were assessed 12 weeks after the switch.|after 12 weeks of treatment|Full Analysis Set (FAS) For Efficacy, defined as all randomized participants who were randomized after the 2nd protocol amendment||percentage of participants|||Number
824642|NCT01183234|Primary|Time of Maximum Plasma Concentration (Tmax) for MPH Using Two Different Formulations (Equasym XL and Metadate CD)|Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached.|predose and 0.5, 1.0, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20 and 24 hours post-dose|PK set||hours||Full Range|Median
824769|NCT01178268|Other Pre-specified|The Composite of ST, All Death, and All MI Rate in Patients Without Diabetic Disease|The composite of ST, all death, and all MI rate in Non Diabetes|24 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824643|NCT01183234|Primary|Maximum Plasma Concentration (Cmax) for MPH Using Two Different Formulations (Equasym XL and Metadate CD)|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|predose and 0.5, 1.0, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20 and 24 hours post-dose|PK set||ng/ml||90% Confidence Interval|Least Squares Mean
824644|NCT01183234|Primary|Area Under the Steady-state Plasma Concentration-time Curve (AUC 0-t) for Methylphenidate Hydrochloride (MPH) Using Two Different Formulations (Equasym XL and Metadate CD)|AUC 0-t is the area under the plasma concentration versus time curve from time 0 to the time of last quantifiable concentration. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|predose and 0.5, 1.0, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20 and 24 hours post-dose|Pharmacokinetic analysis set (PK) defined as all subjects in the safety analysis set who had evaluable plasma concentration-time profiles for MPH through 24 hours post-dosing in both treatment periods. Subjects who vomited or experienced significant diarrhea between dosing and 10 hours post-dose were excluded.||ng*h/ml||90% Confidence Interval|Least Squares Mean
824645|NCT01183312|Secondary|EEG Power||following drug administration||||||
824646|NCT01183312|Secondary|Change in Stanford Sleepiness Scale|The Stanford Sleepiness Scale (SSS) is a subjective rating of sleepiness, with score ranging from 1 to 7, where higher values reflect more severe sleepiness. The measure used was change in SSS from baseline to drug administration (calculated as baseline value - average value with study drug, where higher numbers denote improvement from baseline).|10, 30, 60, 90, 120, and 150 minutes after drug administration (averaged for all time points for each subject)|Intention to treat (all randomized subjects were included)||units on a scale||Standard Deviation|Mean
824647|NCT01183312|Secondary|PVT Additional Measure #5, Change in Visual Analog Scale Rating of Sleepiness at the Completion of PVT|At the end of the 10 minute PVT testing period, subjects were asked to rate their current level of sleepiness along a line, which was transformed into a numeric value from 1-10, such that high levels indicated more severe subjective sleepiness. The measure used was the change in this rating from baseline to drug administration (calculated as baseline value - average value with study drug, where higher numbers denote improvement from baseline).|10, 30, 60, 90, 120, and 150 minutes after drug administration (averaged for all time points for each subject)|Intention to treat (all randomized subjects were included)||units on a scale||Standard Deviation|Mean
824648|NCT01183312|Secondary|PVT Additional Measure #4, Change in False Response Frequency|The false response frequency is defined as the number of button presses when no stimulus is presented. The measure used was the change in false response frequency from baseline to drug administration (calculated as baseline value - average value with study drug, where higher numbers denote improvement from baseline).|10, 30, 60, 90, 120, and 150 minutes after drug administration (averaged for all time points for each subject)|Intention to treat (all randomized subjects were included)||number of false starts||Standard Deviation|Mean
824649|NCT01183312|Secondary|PVT Additional Measure #3, Change in Optimum Response Times|The optimum response times is defined as the reciprocal of the reaction time averaged across the fastest 10% of responses. The measure used was the change in optimum response time from baseline to following drug administration (calculated as baseline value - average value with study drug, where lower numbers denote improvement from baseline).|10, 30, 60, 90, 120, and 150 minutes after drug administration (averaged for all time points for each subject)|Intention to treat (all randomized subjects were included)||1/msec||Standard Deviation|Mean
824650|NCT01183312|Secondary|PVT Additional Measure #2, Change in Duration of Lapse Domain|The PVT duration of lapse domain is defined as the reciprocal of the reaction time averaged across the slowest 10% of responses. The measure used was the change in duration of lapse domain from baseline to drug administration (calculated as baseline value - average value with study drug, where lower numbers denote improvement from baseline).|10, 30, 60, 90, 120, and 150 minutes after drug administration (averaged for all time points for each subject)|Intention to treat (all randomized subjects were included)||1/msec||Standard Deviation|Mean
824651|NCT01183312|Secondary|PVT Additional Measure #1, Change in Lapse Frequency|A PVT lapse is defined as a reaction time exceeding 500 msec following the presentation of a single stimulus, which are then summed for the entire 10 minute PVT testing period. The measure used was the change in the frequency of lapses from baseline to drug administration (calculated as baseline value - average value with study drug, where higher numbers denote improvement from baseline).|10, 30, 60, 90, 120, and 150 minutes after drug administration (averaged for all time points for each subject)|Intention to treat (all randomized subjects were included)||number of lapses during PVT testing||Standard Deviation|Mean
824652|NCT01183312|Primary|Change in Psychomotor Vigilance Task (PVT) Median Reaction Time|The PVT measures the reaction time to button press following the presentation of a visual stimulus, reported here as the median reaction time for multiple presentations during the 10 minute task. The measure used was the change in median reaction time from baseline to drug administration, where the median reaction time at each of the time points (below) was averaged to provide a single on-treatment value for median reaction time. The measure was then calculated as baseline value - treatment value, such that higher numbers denote improvement from baseline.|10, 30, 60, 90, 120, and 150 minutes after drug administration (averaged for all time points for each subject)|Intention to treat (all randomized subjects were included)||msec||Standard Deviation|Mean
824653|NCT01183390|Primary|AUC0-t of Anastrozole(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on Anastrozole AUC0-t.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
824654|NCT01183390|Primary|Cmax of Anastrozole(Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Anastrozole Cmax.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
824655|NCT01183468|Primary|C-peptide 2-hour AUC in Response to a Mixed-meal Tolerance Test at Week 52|No results for the primary outcome measure are available since the study was terminated prior to reaching the outcome measure time frame of 52 weeks.|Week 52|Enrolled Sample|||||
824694|NCT01184053|Primary|Objective Response (CR+PR) Rate of Subjects Given Trisenox|To estimate the objective response (CR+PR) rate (as defined by the Gynecologic Oncology Group [GOG] RECIST Criteria)of Trisenox® in women with recurrent or metastatic endometrial cancer when administered at 0.25 mg/kg/day for 5 consecutive days (D1-5) every 4 weeks.|28 days|||Participants|||Count of Participants
824656|NCT01183481|Secondary|Control Rate of Delayed Phase Nausea, Vomiting, and Retching in Patients Undergoing Multiple Fraction Radiotherapy|"Percentage of participants experiencing no nausea, vomiting, and retching was assessed.
Assessments of nausea, vomiting, and antiemetic use will be taken daily within 2-10 following the radiation therapy based on patient self-report nausea/vomiting diaries."|Days 2-10 following radiotherapy|Patients undergoing multiple fraction treatment||percentage of participants|||Number
824657|NCT01183481|Secondary|Control Rate of Acute Phase Nausea, Vomiting, and Retching in Patients Undergoing Multiple Fraction Radiotherapy|"Percentage of participants in the multiple fraction arm experiencing no nausea, vomiting, and retching was assessed.
Data will be measured by research staff at baseline and patient self-report nausea diaries will be taken on each day within this time frame."|During radiotherapy (5 days) and the 24 hours following radiotherapy|Patients undergoing multiple fraction treatment||percentage of participants|||Number
824658|NCT01183481|Secondary|Control Rate of Delayed Phase Nausea, Vomiting, and Retching in Patients Undergoing Single Fraction Radiotherapy|"Percentage of participants in the single fraction arm experiencing no nausea, vomiting, and retching was assessed.
Assessments of nausea, vomiting, and antiemetic use will be taken daily within 2-10 following the radiation therapy based on patient self-report nausea/vomiting diaries."|Days 2-10 following radiotherapy|Patients undergoing single fraction treatment||percentage of participants|||Number
824659|NCT01183481|Secondary|Control Rate of Acute Phase Nausea, Vomiting, and Retching in Patients Undergoing Single Fraction Radiotherapy|"Percentage of participants experiencing no nausea, vomiting, and retching during the acute phase was assessed.
Assessments of nausea, vomiting, and antiemetic use will be taken daily following the radiation therapy based on patient self-report nausea/vomiting diaries."|Day of radiotherapy and 24 hours following|Patients undergoing single fraction treatment||percentage of participants|||Number
824660|NCT01183481|Secondary|The Complete RINV Prophylaxis Rate (Acute and Delayed Phases), the Partial Emesis Control Rate, the Safety of the Combined Regime, QOL Issues, the Time to the First Emetic Event and Use of Rescue Medication .|Data will be measured by research staff at baseline and patient self-report nausea diaries will be taken on each day within this time frame.|From day of radiotherapy to 10 days following radiotherapy||||||
824661|NCT01183481|Primary|The Proportion of Patients Experiencing no Vomiting and no Nausea, Without Use of Any Rescue Antiemetic Medication(s), From Days 2-10 Following the Radiation Therapy (Delayed RINV).|Assessments of nausea, vomiting, and antiemetic use will be taken daily within 2-10 following the radiation therapy based on patient self-report nausea/vomiting diaries.|Days 2-10 following radiotherapy|||participants|||Number
824662|NCT01183533|Secondary|Mortality||90 days|Note: although 2 patients were not available for complete day 90 assessments, family/patient communication provided necessary mortality information.||participants|||Number
824663|NCT01183533|Secondary|90-day Modified Rankin Scale (mRS) Score 0 or 1|Number of patients with mRS of 0 or 1 at 90 days. The mRS is a clinician-reported measure of global disability that has been widely applied for evaluating recovery from stroke. It has a minimum of 0 and a maximum of 6. Zero represents a patient that has no disability or residual stroke symptoms. A score of 1 is defined as: no significant disability: despite symptoms, able to carry out all usual duties and activities. The maximum score, 6, indicates death. A score of 2 is defined as slight disability: unable to perform all previous activities but able to look after own affairs without assistance; a score of 3 is defined as moderate disability: requiring some help but able to walk without assistance; a score of 4 is moderately severe disability: unable to walk without assistance and unable to attend to own bodily needs without assistance; a score of 5 is severe disability: bedridden, incontinent and requiring constant nursing care and attention.|90 days|^ Note: 2 patients were not available for 90-day follow-up assessments.||participants|||Number
824664|NCT01183533|Primary|Frequency of Symptomatic Hemorrhagic Transformation Safety of iv Rt-PA in Wake up Stroke Patients|The primary outcome of this study is the frequency of symptomatic hemorrhagic transformation evident within 24 hours of treatment with IV t-PA. Symptomatic was defined as significant clinical deterioration with at least a 4 point or more increase in the NIH Stroke scale.|24 hours|||cases.|||Number
824665|NCT01183546|Secondary|Shoulder Peak Resultant Moment|Shoulder Peak Resultant Moment during wheelchair transfers was calculated using an inverse dynamics model approach. Inputs into the model included forces recorded at the hands during transfers, three-dimensional motion trajectories of markers placed on the upper limbs and trunk, and subject's anthropometric data.|Baseline Testing and at Followup Testing (4 weeks)|||Newton-meter/kilogram||Standard Deviation|Mean
824666|NCT01183546|Primary|Transfer Performance (TAI Scores Part 1)|"Part 1 of the TAI is comprised of 15 items which are scored yes (1 point) when the subject performs the specified skill correctly and no (0 points) when the subject performs the skill incorrectly or (N/A) which means the item does not apply. The part 1 summary score is the summation of each item's score multiplied by 10, and then divided by the number of applicable items, ranging from 0 to 10."|Baseline Testing and at Followup Testing (4 weeks)|||units on a scale||Standard Deviation|Mean
824667|NCT01183650|Primary|Pharmacokinetics: Time to Concentration Maximum (Tmax) of Tadalafil and Metabolite IC710||1 day and 10 days|All enrolled participants||hours||Full Range|Median
824668|NCT01183650|Primary|Pharmacokinetics: Concentration Maximum (Cmax) of Tadalafil and Metabolite IC710||1 day and 10 days|All enrolled participants||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
824669|NCT01183650|Primary|Pharmacokinetics: Area Under the Concentration Curve (AUC) for Tadalafil and Metabolite IC710|AUC for Day 1 is reported as AUC(tau [t], day 1), which is AUC from time zero to 24 hours (t) postdose on Day 1. AUC for Day 10 is reported as AUC(t,steady state [ss]), which is AUC during one 24-hour dosing interval at steady-state.|1 day and 10 days|All enrolled participants||nanograms*hour/milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
824679|NCT01183858|Secondary|Overall Survival (OS) at the End of Study|OS defined as the time from randomization to the date of death due to any cause.|Randomization to End of Study: 14 October 2010 – 7 February 2014 (Up to 39.8 months)|Intent-to-treat Population included all randomized participants. 2 participants were excluded from analysis: 1 participant randomized in error and 1 participant with missing source data.||months||95% Confidence Interval|Median
824695|NCT01184079|Secondary|Safety Profile|Total proportion of side effects reported after any dose, compared by arm.|1 week after vaccination|Intention-to-treat||percentage of doses with side effects|||Number
824670|NCT01183728|Secondary|Indication of Efficacy|"Clinical exploration, questionaires (VAS, WOMAC, Lequesne Index, SF-36 life quality) at all the periods. To evaluate effectiveness through development of criteria for quantitative MRI (Cartigram) denoting regeneration of articular cartilage at 6, 12 and 24 months after the implantation of MSV.
Magnetic Resonance imaging measurements of T2 relaxation (Cartigram) performed at 0, 6 and 12 months to quantify articular cartilage degeneration. The values (in milliseconds) are T1/2 for decay of the T2 MRI signals. Normal values are below 50 ms; values above 50 ms correspond to inflamed cartilage.
Mean (SD) are expressed as the percent of values (of a total of 88 measurements) that are between 50 and 90 ms. A value =5 is considered normal (can be attained by chance). Values above 5 are considered pathological. The worst possible is 100."|0, 6, 12, 24 months|||percentage of values||Standard Deviation|Mean
824671|NCT01183728|Primary|Feasibility and Safety of the Implementation of MSV in the Treatment of Osteoarthritis of the Knee.|"Clinical review, questionaires (VAS - Visual Analogue Scale (a psychometric response scale which can be used for subjective measurements of knee pain), WOMAC - Western Ontario and McMaster Universities Osteoarthritis Index (questionnaire to quantify the pain, stiffness and physical function in patients with osteoarthritis of the knee or hip), Lequesne Index (is a composite measure of pain and disability, with specific self-report questionnaires for knee (osteoarthritis)), SF36 life quality - Short Form 36 (is a questionnaire for the detection of changes in quality of life)).
In all cases, the scale was from 0 to 100%. Measurements were performed before cell transplantation (0) and 3, 6, 12 and 24 months afterwards depending on the questionnaire. For VAS, WOMAC and Lequesne, lower values represent a better outcome. For SF-36, higher values represent a better outcome.
VAS-DA, VAS for pain associated to daily activities. VAS-SP, VAS for pain associated to sports activities."|0, 3, 6, 12 and 24 months|||units on a scale||Standard Deviation|Mean
824672|NCT01183780|Secondary|Observed Maximum Concentration (Cmax) and Observed Minimum Concentration (Cmin) of Ramucirumab||Preinfusion and 1 hour postinfusion in Cycles 3, 5, 9, 13, and 17|All randomized participants who received at least one dose of study drug and had evaluable data for Cmin and Cmax.||micrograms/milliliter (ug/mL)||Geometric Coefficient of Variation|Geometric Mean
824673|NCT01183780|Secondary|Percentage of Participants With Treatment-Emergent Anti-Ramucirumab Antibodies|Blood samples were tested to determine if a participant reacted to ramucirumab by producing anti-ramucirumab antibodies. Samples were identified as treatment emergent anti-drug antibody (TE ADA) if the post-treatment sample had an increase of at least 4 fold in titer from pre-treatment values. If the pre-treatment value was not detected or was not present, a 1:20 post-treatment titer was required to indicate treatment emergence. The percentage of participants with TE ADA was calculated as: (the number of participants with TE ADA / total number of participants with at least 1 post-treatment immunogenicity sample analyzed)*100.|Cycles 1, 3, 5, and 30-Day FU|All participants who received study treatment and who had immunogenicity samples analyzed at the specified time points.||percentage of participants|||Number
824674|NCT01183780|Secondary|Change From Baseline in EuroQol- 5D (EQ-5D)|The EQ-5D is a generic, multidimensional, health status instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a 3-level scale (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension). A negative change indicated a worsening of the participant's health status.|Baseline and 30-Day Follow-Up (FU) up to 171 Weeks|All randomized participants who had EQ-5D assessed at baseline and 30-day FU.||units on a scale||Standard Deviation|Mean
824675|NCT01183780|Secondary|Change From Baseline in European Organisation for Research and Treatment of Cancer [EORTC] QLQ-C30 Global Health Status|The EORTC QLQ-C30 (v. 3.0) is a self-administered, cancer-specific questionnaire with multidimensional scales assessing 15 domains (5 functional domains, 9 symptoms, and global health status). A linear transformation was applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For the functional domains and global health status scale, higher scores represent a better level of functioning. For symptom scales, higher scores represent a greater degree of symptoms. Maximum improvement is the best post-baseline change.|Baseline Up to 171 Weeks|All randomized participants who had EORTC QLQ-C30 assessed at baseline and post-baseline .||units on a scale||Standard Deviation|Mean
824676|NCT01183780|Secondary|Percentage of Participants Achieving an Objective Response (Objective Response Rate)|The objective response rate is equal to the proportion of participants achieving a best overall response of partial response or complete response (PR + CR). Response was defined using RECIST, v. 1.1 criteria. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm and normalization of tumor marker level of non-target lesions; PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions taking as reference the baseline sum diameter.|Randomization until Disease Progression Up to 38.01 Months|All randomized participants.||percentage of participants||95% Confidence Interval|Number
824677|NCT01183780|Secondary|Progression-free Survival (PFS) Time|PFS was defined as the time from the date of randomization until the date of objectively determined progressive disease (PD) [according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v). 1.1] or death due to any cause, whichever was first. PD is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). Participants who died without a reported prior progression were considered to have progressed on the day of their death. Participants who did not progress or were lost to follow-up were censored at the day of their last radiographic tumor assessment.|Randomization to Measured PD or Date of Death from Any Cause Up to 38.01 Months|All randomized participants. Participants censored: Ramucirumab + FOLFIRI = 60; Placebo + FOLFIRI = 42.||months||95% Confidence Interval|Median
824678|NCT01183780|Primary|Overall Survival (OS)|OS was defined as the time in months from the date of randomization to the date of death from any cause. For participants not known to have died as of the cut-off date, OS was censored at the last known date alive.|Randomization to Date of Death from Any Cause Up to 39.36 Months|All randomized participants. Participants censored: Ramucirumab + FOLFIRI group = 164; Placebo + FOLFIRI= 139.||months||95% Confidence Interval|Median
824680|NCT01183858|Primary|Progression-Free Survival (PFS) at the End of Study|PFS is defined as the time from randomization to the date of first occurrence of disease progression or death. For target lesions, Progressive Disease (PD) was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.|Randomization to End of Study: 14 October 2010 – 7 February 2014 (Up to 39.8 months)|Intent-to-treat Population included all randomized participants. 2 participants were excluded from analysis: 1 participant randomized in error and 1 participant with missing source data.||weeks||95% Confidence Interval|Median
824681|NCT01183858|Secondary|Number of Participants With Adverse Events (AEs) at the End of the Study|"An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events.
A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
Adverse Events in the following categories are presented: Adverse Events, Serious Adverse Events, AEs leading to withdrawal from treatment and AEs leading to death."|Randomization to End of Study: 14 October 2010 – 7 February 2014 (Up to 39.8 months)|Safety population included all randomized participants who received at least one dose of study drug.||participants|||Number
824682|NCT01183858|Secondary|Time to Progression (TTP)|Tumor response was assessed by the investigator using computer tomography (CT) or magnetic resonance imaging (MRI) scans according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria. Time to progression (TTP) in weeks was defined as the time from randomization to the date of disease progression. Participants without event were censored at the date of the last tumor assessment when the patient was known to be progression free.|Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)|Intent-to-treat Population included all randomized participants. 2 participants were excluded from analysis: 1 participant randomized in error and 1 participant with missing source data.||weeks||95% Confidence Interval|Median
824683|NCT01183858|Secondary|Disease Control Rate (DCR)|Tumor response was assessed by the investigator using computer tomography (CT) or magnetic resonance imaging (MRI) scans. Disease control rates were measured according to RECIST version 1.1 criteria. A participant was defined as having controlled disease if they sustained a Complete Response (CR) or Partial Response (PR) for at least 4 weeks during randomized treatment (confirmed response), or Stable Disease (SD) for at least 6 weeks. Patients with no tumor assessment after the start of study treatment were considered as having uncontrolled disease. The percentage of participants with Disease Control is presented.|Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)|Intent-to-treat Population included all randomized participants. 2 participants were excluded from analysis: 1 participant randomized in error and 1 participant with missing source data.||percentage of participants||95% Confidence Interval|Number
824684|NCT01183858|Secondary|Overall Response Rate (ORR)|Tumor response was assessed by the investigator using computer tomography (CT) or magnetic resonance imaging (MRI) scans according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. A participant was defined as a responder if they sustained a complete response (CR) or partial response (PR) for at least 4 weeks during randomized treatment (confirmed response). Patients with no tumor assessment after the start of study treatment were to be considered as non-responders. The percentage of participants in each best response category is presented.|Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)|Intent-to-treat Population included all randomized participants. 2 participants were excluded from analysis: 1 participant randomized in error and 1 participant with missing source data.||percentage of participants||95% Confidence Interval|Number
824685|NCT01183858|Secondary|Overall Survival (OS)|OS defined as the time from randomization to the date of death due to any cause.|Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)|Intent-to-treat Population included all randomized participants. 2 participants were excluded from analysis: 1 participant randomized in error and 1 participant with missing source data.||months||95% Confidence Interval|Median
824686|NCT01183858|Primary|Progression-Free Survival (PFS)|PFS is defined as the time from randomization to the date of first occurrence of disease progression or death. For target lesions, Progressive Disease (PD) was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.|Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 Months)|Intent-to-treat Population included all randomized participants. 2 participants were excluded from analysis: 1 participant randomized in error and 1 participant with missing source data.||weeks||95% Confidence Interval|Median
824687|NCT01183975|Primary|Mean Excess Weight Change|Mean excess weight change in valid subjects. Excess weight is calculated as body weight minus ideal body weight, where ideal body weight is determined by the method of Lorentz (Ein neuer Konstitionsinde. Klin Wochenschr 1929; 8:348-51).|3 years follow up|||percent change in excess weight||Standard Deviation|Mean
824688|NCT01183975|Primary|Mean BMI Change|Mean change in BMI for valid subjects|3 years follow-up|517 valid patients analyzed||kg/m^2||Standard Deviation|Mean
824689|NCT01184014|Secondary|the Mean Blood Glucose of All Blood Glucose Readings|as stated above|starting 3 hours after the initial index BG>180 measure, across the entire hospital stay or up through 5 days if hospital LOS is > 5 days||||||
824690|NCT01184014|Primary|Mean Blood Glucose.|as stated above|discharge or until after their 5th day in the hospital|||mg/dL||Standard Deviation|Mean
824691|NCT01184053|Secondary|Associations Between Markers of Angiogenesis (e.g. VEGF) With Response|We will request a blood sample to measure vascular endothelial growth factor (VEGF) as well as other angiogenic factors and correlate levels to response to arsenic trioxide. Such effects have been observed in cultured cell lines and animal models, as well as clinical studies.|4 years|No patients achieved a CR or PR response, no angiogenesis was performed.|||||
824692|NCT01184053|Secondary|Overall Survival||5 years|All patients who received treatment||days||95% Confidence Interval|Median
824697|NCT01184079|Primary|Immunogenicity After Dose 3|Geometric mean titer (GMT) and 95% confidence intervals around titer 1 month after dose 3 in per protocol population, comparing the two groups.|1 month after dose 3 (e.g., month 7 if third dose at 6months or month 13 if third dose at 12 months)|Intention-to-treat||mM units/ml||95% Confidence Interval|Geometric Mean
824698|NCT01184118|Secondary|Number of Participants With Improved, Unchanged, and Worsened Anterior Tongue Strength (KPa) From Baseline With 16-week of High Dose Inhaled FP Treatment.|The Iowa Oral Performance Instrument (IOPI) will be used. This instrument has a standard-sized air-filled polymer balloon, called tongue sensor or bulb, which can be inserted between the tongue blade and the roof of the mouth. Anterior tongue strength (KPa) reported. Subjects were divided into 3 subgroups: improved (lower anterior tongue strength KPa), unchanged, or worsened (higher anterior tongue strength KPa).|16 weeks|||participants|||Number
824699|NCT01184118|Secondary|Number of Participants With Improved, Unchanged, and Worsened Sleep Disorders Questionnaire (SA-SDQ) From Baseline With 16-week of High Dose Inhaled FP Treatment.|Secondary goals include evaluating effects of this medication on severity of obstructive sleep disordered breathing (SDB) (validated by Sleep Disorders Questionnaire (SA-SDQ)). Subjects were divided into 3 subgroups: improved (less negative SA-SDQ score), unchanged, or worsened (more negative SA-SDQ score).|16 weeks|||participants|||Number
824700|NCT01184118|Primary|Number of Participants With Improved, Unchanged, and Worsened Critical Closing Pressure (Pcrit) From Baseline With 16-week of High Dose Inhaled FP Treatment.|Upper airway (UAW) collapsibility, as measured by critical closing pressure (Pcrit), defined as the maximum nasal pressure at which the UAW occludes. Subjects were divided into 3 subgroups: improved (more negative Pcrit), unchanged, or worsened (less negative Pcrit).|16 weeks|||participants|||Number
824701|NCT01184417|Secondary|Number of Study Patients With Mortality as a Measure of Safety and Tolerability|mortality in study patients|1 year|||participants|||Number
824702|NCT01184417|Secondary|Number of Study Patients With Seizure as a Measure of Safety and Tolerability|Did the study patient have a witnessed seizure during their hospitaliztion (yes/no).|1 year|||participants|||Number
824703|NCT01184417|Secondary|Percentage of Patients Requiring a Bedside Sitter as a Measure of Safety and Tolerability|"Did the study patient require a Licensed Vocational Nurse (LVN) or other hospital staff to serve as a bedside sitter to observe the patient and provide additional safety supervision during any portion of their hospitalization."|1 year|||percentage of participants|||Number
824704|NCT01184417|Secondary|Number of Patients Requiring Endotracheal Intubation as a Measure of Safety and Tolerability|"The outome answeres the question Did the study patient require endotracheal intubation, or not. This outcome investigates if the phenobarbital intervention is associted with increased incidence of respiratory depression and subsequent increased need for intubation."|1 year|||participants|||Number
824705|NCT01184417|Secondary|Length of Stay|hospital LOS, per patient, in hours from admission to discharge|1 year|||hours||Inter-Quartile Range|Median
824706|NCT01184417|Primary|Total Lorazepam Required Per Patient Per Admission|How much total lorazepam did each study patient receive from inital presentation in the Emergency Department through their discharge from the hospital, in milligrams.|1 year|||milligrams||Standard Deviation|Mean
824707|NCT01184417|Primary|Percentage of Patients Requiring ICU Admission|admission to intensive care unit|1 year|||percentage of participants|||Number
824708|NCT01184417|Primary|Number of Patients Requiring Continuous Lorazepam Infusion|"All study patients are placed on the standardized institutional alcohol withdrawal protocol and receive boluses of lorazepam (1, 2 or 4 mg IV) based on their acute alcohol withdrawal score (AAWS), adminstered serially up to every 15 minutes. Patients who are refractory to the maximum dose of lorazepam allowed by the protocol (up to 4mg lorazepam IV q 15 mins)are placed on a continuous IV lorazepam infusion (or lorazepam drip). Thus, continuous lorazepam infusion is a yes or no variable (i.e. continuous infusion, or not)."|1 year|||participants|||Number
824709|NCT01177943|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-tlast)]|The AUC (0-tlast) is the area under the plasma concentration versus time curve from time zero (predose) to time of last quantifiable concentration (tlast) and is based on the atomoxetine plasma concentration. The Least Squares (LS) Mean Value was based on treatment, period, group, and subject.|Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 4, 6, 8, 12, 18, and 24 hours post dose|All participants who had an AUC value were included in the AUC analysis.||nanogram hour per milliliter (ng*h/mL)||90% Confidence Interval|Least Squares Mean
824710|NCT01177943|Primary|Maximum Observed Plasma Concentration (Cmax)|The Cmax values are based on the atomoxetine plasma concentration. The Least Squares (LS) Mean Value was based on treatment, period, group, and subject.|Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 4, 6, 8, 12, 18, and 24 hours post dose|All participants who had a Cmax value were included in the Cmax analysis.||nanogram per millileter (ng/mL)||90% Confidence Interval|Least Squares Mean
824711|NCT01177956|Secondary|Duration of Response Until Cut-off Date 15 November 2012|Time from first assessment of CR or PR to disease progression or death (within 60 days of last tumor assessment). Participants without event are censored on the date of last tumor assessment. Tumor assessments based on modified WHO criteria.|Evaluations were performed every 6 weeks until progression, reported between day of first participant randomized, 25 December 2009, until cut-off date 15 November 2012|Subgroup of participants from the study population having best confirmed response (CR or PR).||months||95% Confidence Interval|Median
824712|NCT01177956|Secondary|Duration of Response Until Cut-off Date 25 January 2011|Time from first assessment of CR or PR to disease progression or death (within 60 days of last tumor assessment). Participants without event are censored on the date of last tumor assessment. Tumor assessments based on modified WHO criteria.|Evaluations were performed every 6 weeks until progression, reported between day of first participant randomized, 25 December 2009, until cut-off date 25 January 2011|Subgroup of participants from the study population having best confirmed response (CR or PR).||months||95% Confidence Interval|Median
824713|NCT01177956|Secondary|Time to Progression (TTP) Until Cut-off Date 15 November 2012|Time from first administration of trial treatment to disease progression (radiological or clinical, if radiological progression is not available). Participants without event are censored on the date of last tumor assessment.|Evaluations were performed every 6 weeks until progression, reported between day of first participant randomized, 25 December 2009, until cut-off date 15 November 2012|ITT population included all participants who received at least one dose of the IMP cetuximab or chemotherapy.||months||95% Confidence Interval|Median
824714|NCT01177956|Primary|Best Overall Response (BOR) Until Cut-off Date 15 November 2012|BOR: Percentage of participants experiencing a CR (complete disappearance of measurable and evaluable disease without new lesions) or PR (greater than or equal to 50 percent decrease of sum of product diameters of measurable disease, evaluable disease not worsening or progressing, no new lesions confirmed by a subsequent assessment no less than 28 days after criteria for response were first met) (based on modified WHO criteria), divided by the number of participants belonging to ITT or safety population.|Evaluations were performed every 6 weeks until progression, reported between day of first participant randomized, 25 December 2009, until cut-off date 15 November 2012|ITT population included all participants who received at least one dose of the investigational medicinal product (IMP) cetuximab or chemotherapy.||percentage of participants||95% Confidence Interval|Number
824715|NCT01177956|Secondary|Time to Progression (TTP) Until Cut-off Date 25 January 2011|Time from first administration of trial treatment to disease progression (radiological or clinical, if radiological progression is not available). Participants without event are censored on the date of last tumor assessment.|Evaluations were performed every 6 weeks until progression, reported between day of first participant randomized, 25 December 2009, until cut-off date 25 January 2011|ITT population included all participants who received at least one dose of the IMP cetuximab or chemotherapy.||months||95% Confidence Interval|Median
824716|NCT01177956|Secondary|Progression-free Survival (PFS) Time Until Cut-off Date 15 November 2012|Duration from first administration of trial treatment until progression (radiological or clinical, if radiological progression is not available) or death due to any cause. Only deaths within 60 days of last tumor assessment are considered. Participants without event are censored on the date of last tumor assessment.|Evaluations were performed every 6 weeks until progression, reported between day of first participant randomized, 25 December 2009, until cut-off date 15 November 2012|ITT population included all participants who received at least one dose of the IMP cetuximab or chemotherapy.||months||95% Confidence Interval|Median
824717|NCT01177956|Secondary|Progression-free Survival (PFS) Time Until Cut-off Date 25 January 2011|Duration from first administration of trial treatment until progression (radiological or clinical, if radiological progression is not available) or death due to any cause. Only deaths within 60 days of last tumor assessment are considered. Participants without event are censored on the date of last tumor assessment.|Evaluations were performed every 6 weeks until progression, reported between day of first participant randomized, 25 December 2009, until cut-off date 25 January 2011|ITT population included all participants who received at least one dose of the IMP cetuximab or chemotherapy.||months||95% Confidence Interval|Median
824718|NCT01177956|Secondary|Overall Survival (OS) Time Until Cut-off Date 15 November 2012|The OS time was defined as the time from first administration of trial treatment to death. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.|Time from randomization to death or last day known to be alive, reported between day of first participant randomized, 25 December 2009, until cut-off date 15 November 2012|ITT population included all participants who received at least one dose of the IMP cetuximab or chemotherapy.||months||95% Confidence Interval|Median
824719|NCT01177956|Primary|Best Overall Response (BOR) Until Cut-off Date 25 January 2011|BOR: Percentage of participants experiencing a Complete Response (CR) (complete disappearance of measurable and evaluable disease without new lesions) or Partial Response (PR) (greater than or equal to 50 percent decrease of sum of product diameters of measurable disease, evaluable disease not worsening or progressing, no new lesions confirmed by a subsequent assessment no less than 28 days after criteria for response were first met) (based on modified World Health Organization [WHO] criteria), divided by the number of participants belonging to intention to treat (ITT) or safety population.|Evaluations were performed every 6 weeks until progression, reported between day of first participant randomized, 25 December 2009, until cut-off date 25 January 2011|ITT population included all participants who received at least one dose of the IMP cetuximab or chemotherapy.||percentage of participants||95% Confidence Interval|Number
824720|NCT01177969|Secondary|Anxiety Disorders Interview Schedule: Child and Parent Versions|The Anxiety Disorders Interview Schedule: Child and Parent Versions are clinician-rated scales assessing anxiety symptoms and the associated severity and impairment in children over the past month. The clinician interviewer interviews the child and parent separately about the nature and severity of the child's anxiety. If a child meets criteria for an anxiety disorder, a single item is rated by the interviewer, which represents anxiety severity. The scale score for this single item ranges from 0 to 8 with higher scores indicating more severe anxiety symptoms.|Post-treatment, which was an average of 16 weeks after Baseline|||units on a scale||Standard Deviation|Mean
824721|NCT01177969|Primary|Pediatric Anxiety Rating Scale.|The Pediatric Anxiety Rating Scale is a clinician-rated scale assessing anxiety symptoms and the associated severity and impairment in children over the past week. The scale includes 5 items which are summed to form a total score, which represents anxiety severity. The scale score ranges from 0 to 25 with higher scores indicating more severe anxiety symptoms.|Post-treatment, which is an average of 16 weeks after Baseline|||units on a scale||Standard Deviation|Mean
824722|NCT01178073|Secondary|Change From Baseline in Borg Dyspnea Index at Week 24|Borg Dyspnea Index (BDI) indicates the degree of breathlessness after completion of the 6 minute walk test. The BDI was calculated by using the Borg category (C) ratio (R) CR10 scale which starts at 0 (nothing at all) and has no upper limit (extremely strong). Change from BL was calculated as the Week 24 values minus the BL value. The BDI scale was assessed by each participant. The BL BDI score is the average of the two BDI values obtained following the two 6MWD tests used in determining the BL 6MWD. A negative change from BL in the BDI score represented an improvement for the participant. The analysis was performed based on the last observation carried forward data, except in the case of an adjudicated clinical failure event of death or hospitalization preceding the missing data observation. In this case, the missing observation was assigned the worst-rank score relative to those actually observed and was assigned rank reflecting the relative order of the actual event times.|Baseline (BL) and Week 24|mITT Population. Only participants with Baseline data were analyzed.||Scores on a scale||Inter-Quartile Range|Median
824770|NCT01178268|Other Pre-specified|The Composite of ST, All Death, and All MI Rate in Patients With Diabetic Disease.|The composite of ST, all death, and all MI rate in All Diabetes patients.|24 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824723|NCT01178073|Secondary|Change From Baseline in the World Health Organization Functional Class at Week 24|The WHO Functional Class (FC) indicates the severity of PAH and is an adaptation of the New York Heart Association classification. It was assessed by the investigator. There are four grades for WHO FC based on severity of symptoms (Class I = none, Class IV = most severe). Baseline WHO FC is the latest assessment prior to dosing (i.e., at Randomization or Screening). Change from Baseline at Week 24 was calculated as the Week 24 value minus the Baseline value. The analysis was performed based on the last observation carried forward data, except in the case of an adjudicated clinical failure event of death or hospitalization preceding the missing data observation. In this case, the missing observations was assigned the worst-rank score relative to those actually observed and was assigned rank reflecting the relative order of the actual event times.|Baseline and Week 24|mITT Population. Only participants with Baseline data were analyzed.||Scores on a scale||Inter-Quartile Range|Median
824724|NCT01178073|Secondary|Change From Baseline in the 6 Minute Walk Distance Test at Week 24|The 6-minute walk distance (6MWD) test measures the distance that a participant can walk in a period of 6 minutes. Change from Baseline was calculated as the Week 24 value minus the Baseline value. The analysis was performed based on last observation carried forward data, except in the case of an adjudicated clinical failure event of death or hospitalization preceding the missing data observation. In this case, the missing observation was assigned the worst-rank score relative to those actually observed and was assigned a rank reflecting the relative order of the actual event times. Baseline 6MWD comprised of an average of the last two consecutive measurements prior to randomization that varied by no greater than 10%. If only one measurement was available, that measurement was used. If no two consecutive measures vary by no greater than 10% then Baseline was based on the last two consecutive measures for a participant.|Baseline and Week 24|mITT Population. Only participants with Baseline data were analyzed.||Meters||95% Confidence Interval|Median
824725|NCT01178073|Secondary|Percentage of Participants With a Satisfactory Clinical Response at Week 24|A satisfactory clinical response at Week 24 is defined as a participant who meets all of the following criteria: 10% improvement in 6MWD compared with Baseline; improvement to or maintenance of World Health Organization (WHO) class I or II symptoms; no events of clinical worsening prior to or at the Week 24 visit. Clinical worsening events included: death, hospitalization for pulmonary arterial hypertension (PAH), and disease progression. Participants without an event of clinical worsening prior to or at the Week 24 visit who did not have a 6MWD value or a WHO functional class value at Week 24 were excluded from the analysis.|Baseline and Week 24|"mITT Population. Only those participants who had a Yes/No response were analyzed."||Percentage of participants|||Number
824726|NCT01178073|Secondary|Percent Change From Baseline in the N-Terminal Pro-B-Type Natriuretic Peptide at Week 24|N-Terminal Pro-B-Type Natriuretic Peptide (NT-proBNP) is a surrogate marker of heart failure. The data were log-transformed. The geometric mean was calculated (based on the log-transformed data). The geometric mean ratio was calculated as the ratio between the Week 24 value and the Baseline value (based on the log-transformed data) and presented as percent change = 100 * (geometric mean ratio – 1). The Baseline value is the last value prior to administration of study drug; this may be prior to or on the day of study drug initiation. No imputation was performed for missing data. The secondary endpoints were analyzed according to a pre-specified hierarchical testing procedure.|Baseline and Week 24|mITT Population. Only participants with data available at the specified time points were analyzed.||Percent change||Standard Error|Mean
824727|NCT01178073|Primary|Number of Participants With First Adjudicated Clinical Failure (CF) Event, Death, Hospitalisation for Worsening PAH, Disease Progression, Unsatisfactory Long-term Clinical Response, All Through FAV|Time to the first adjudicated CF event (death, hospitalization for worsening pulmonary arterial hypertension [PAH], disease progression, or unsatisfactory long-term clinical response) after initiating either first-line combination therapy with AMB and TAD or first-line monotherapy with either drug (AMB or TAD) in par. with PAH was assessed. If data was not available for some par. following a loss to follow-up, their event times were treated as censored at their last assessment time for the statistical analyses. FAV occurred approximately 4 weeks after the predicted 105th adjudicated first CF event was reached. Par. who had an FAV, and who had no adjudicated events or whose first adjudicated event occurred after their FAV, were censored at their individual FAV. Modified Intent-to-Treat (mITT) Population: all randomized par. who met the PAH diagnosis and inclusion/exclusion criteria defined in protocol amendment 2 and who also received at least one dose of investigational product (IP).|From Baseline up to the Final Assessment Visit (FAV) (average of 609 days)|mITT Population||Participants|||Number
824728|NCT01178099|Secondary|P2Y12 Reaction Units (PRU)-Derived VerifyNow (VN) Percent Inhibition at Day 12|"PRU-derived VN percent inhibition is calculated as a percent decrease of PRU from baseline using the following formula:
([PRU at baseline – PRU at time of post baseline] / PRU at baseline) x 100%"|Day 12|All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose.||percent inhibition||Standard Deviation|Mean
824729|NCT01178099|Secondary|Change From Baseline in the Percent Aggregation to 20 µM Adenosine Diphosphate (ADP) at Day 12|Percent aggregation was assessed by Plateletworks® ADP assay, a whole blood-based test of platelet aggregation for the assessment of platelet inhibition. The assay determines the change in single platelet count due to activation and aggregation by ADP and inhibition thereof by antiplatelet agents.|Baseline, Day 12|All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose.||percent aggregation||Standard Deviation|Mean
824730|NCT01178099|Secondary|Change From Baseline in the Area Under the Aggregation Curve at Day 12|AUC to 20 micromolar (μM) adenosine diphosphate (ADP), 6.5μM ADP, Collagen, and thrombin receptor activator for peptide 6 (TRAP-6) were calculated by whole blood multi-electrode aggregometry (MEA) assay. Platelet aggregation was continuously recorded for 5 minutes and quantified as area under the aggregation curve, measured in aggregation units*minutes (AU*min).|Baseline, Day 12|All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose.||aggregation units*minutes (AU*min)||Standard Deviation|Mean
824771|NCT01178268|Other Pre-specified|ID-TVF Rate in Dual Vessel Treated Subgroup|ID-TVF rate in Patients with dual vessel treated during the index procedure.|24 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824731|NCT01178099|Secondary|Change From Baseline in the Platelet Reactivity Index (PRI) of Prasugrel at Day 12|PRI was calculated by vasodilator-associated phosphoprotein (VASP) phosphorylation assay using flow cytometry (FC) and a VASP assay using enzyme-linked immunosorbent assay (ELISA). The PRI indicates the level of P2Y12 inhibition. A low PRI reflects strong inhibition of P2Y12, whereas a high PRI reflects weak/absent inhibition of P2Y12.|Baseline, Day 12|All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose.||percentage PRI||Standard Deviation|Mean
824732|NCT01178099|Secondary|Change From Baseline in the P2Y12 Reaction Units (PRU) Device Reported P2Y12 Percent Inhibition at Day 12|PRU device reported VerifyNow percent inhibition is reported by Accumetrics VerifyNow™ P2Y12 (VN-P2Y12) assay, a point-of-care device that measures platelet aggregation with single-use, disposable cartridges.|Baseline, Day 12|All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose.||percent inhibition||Standard Deviation|Mean
824733|NCT01178099|Secondary|Maximum Concentration (Cmax) of Prasugrel's Inactive Metabolites, R-95913, R-106583, and R-119251|Cmax was observed from the data and used to calculate geometric Least Squares (LS) Means. The log-transformed Cmax was analyzed with a mixed effect model with dose, population, dose*population interaction as fixed effects, and participant as a random effect.|Day 1, Day 12|All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose.||nanogram per milliliter (ng/mL)||95% Confidence Interval|Least Squares Mean
824734|NCT01178099|Secondary|Inhibition of Platelet Aggregation (IPA) to 20 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12|"IPA is calculated as a percent decrease of maximum platelet aggregation (MPA) from baseline using the following formula:
([MPA at baseline – MPA postbaseline] / MPA at baseline) x 100%"|Day 12|All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose.||percent inhibition||Standard Deviation|Mean
824735|NCT01178099|Secondary|Change From Baseline in the Residual Platelet Aggregation (RPA) to 20 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12|RPA is the percentage aggregation as measured by light transmission aggregometry (LTA) at 6 minutes after the addition of 20 μM ADP. LTA is an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing the platelet-rich plasma stimulated with a platelet activator, such as ADP, relative to platelet-poor plasma (100% light transmittance).|Baseline, Day 12|All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose.||percent aggregation||Standard Deviation|Mean
824736|NCT01178099|Secondary|Change From Baseline in the Maximum Platelet Aggregation (MPA) to 20 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12|MPA to 20 μM ADP was assessed by light transmission aggregometry (LTA), an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing the platelet-rich plasma stimulated with a platelet activator, such as ADP, relative to platelet-poor plasma (100% light transmittance). The LTA results were collected as MPA, for which low values indicate strong platelet inhibition.|Baseline, Day 12|All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose.||percent aggregation||Standard Deviation|Mean
824737|NCT01178099|Secondary|Inhibition of Platelet Aggregation (IPA) to 5 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12|"IPA is calculated as a percent decrease of maximum platelet aggregation (MPA) from baseline using the following formula:
([MPA at baseline – MPA postbaseline] / MPA at baseline) x 100%"|Day 12|All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose.||percent inhibition||Standard Deviation|Mean
824738|NCT01178099|Secondary|Change From Baseline in the Residual Platelet Aggregation (RPA) to 5 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12|RPA is the percentage aggregation as measured by LTA at 6 minutes after the addition of 5 μM ADP. LTA is an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing the platelet-rich plasma stimulated with a platelet activator, such as ADP, relative to platelet-poor plasma (100% light transmittance).|Baseline, Day 12|All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose.||percent aggregation||Standard Deviation|Mean
824739|NCT01178099|Secondary|Area Under the Plasma Concentration-Time Curve (AUC) From Time of Dosing Through the Sampling Time of the Last Quantifiable Concentration [AUC(0-tlast)] of Prasugrel’s Inactive Metabolites, R-95913, R-106583, and R-119251|AUC was calculated through the sampling time of the last quantifiable plasma concentration [AUC(0-tlast)]. Geometric Least Squares (LS) Means were obtained. The log-transformed AUC was analyzed with a mixed effect model with dose, population, dose*population interaction as fixed effects, and participant as a random effect.|Day 1, Day 12|All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose.||nanogram*hour per milliliter (ng*h/mL)||95% Confidence Interval|Least Squares Mean
824740|NCT01178099|Secondary|Change From Baseline in the Maximum Platelet Aggregation (MPA) to 5 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12|MPA to 5 μM ADP was assessed by light transmission aggregometry (LTA), an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing the platelet-rich plasma stimulated with a platelet activator, such as ADP, relative to platelet-poor plasma (100% light transmittance). The LTA results were collected as MPA, for which low values indicate strong platelet inhibition.|Baseline, Day 12|All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose.||percent aggregation||Standard Deviation|Mean
824772|NCT01178268|Other Pre-specified|ID-TVF Rate in Single Vessel Treated Subgroup|ID-TVF rate in Patients with single vessels treated during the index procedure.|24 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824741|NCT01178099|Primary|Maximum Concentration (Cmax) of Prasugrel's Active Metabolite, R-138727|Cmax was observed from the data and used to calculate Geometric Least Squares (LS) Means. The log-transformed Cmax was analyzed with a mixed effect model with dose, population, dose*population interaction as fixed effects, and participant as a random effect.|Day 1, Day 12|All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose.||nanogram per milliliter (ng/mL)||95% Confidence Interval|Least Squares Mean
824742|NCT01178099|Primary|Area Under the Plasma Concentration-Time Curve (AUC) From Time of Dosing Through the Sampling Time of the Last Quantifiable Concentration [AUC(0-tlast)] for Prasugrel’s Active Metabolite, R-138727|The AUC of Prasugrel's active metabolite, R-138727, was calculated through the sampling time of the last quantifiable plasma concentration [AUC(0-tlast)]. Geometric Least Squares (LS) Means were obtained. The log-transformed AUC was analyzed with a mixed effect model with dose, population, dose*population interaction as fixed effects, and participant as a random effect.|Time of dosing up to 8 hours post-dose on Day 1 and Day 12|All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose.||nanogram*hour per milliliter (ng*h/mL)||95% Confidence Interval|Least Squares Mean
824743|NCT01178125|Secondary|Percentage of On-Drug Pregnancies in Compliant-Use, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule|Crude pregnancy rate is defined as the percentage of on-drug pregnancies per number of participants in each body mass index (BMI) decile (BMI range, in kg/m^2). The 7-day rule is a standardized process for calculating pregnancy rates. Seven-day rule: a pregnancy was considered “on drug” if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets. Compliant use: did not skip 2 or more consecutive pills, had an overall compliance with IP administration of at least 80%, and did not use a prohibited medication.|thirteen 28-day cycles|Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. 'Compliant-use' set included PITT participants who completed at least 1 28-day cycle and in which no other BCMs were used, and who were deemed to be compliant, per protocol. n=number of participants in BMI decile group.||percentage of pregnancies|||Number
824744|NCT01178125|Secondary|Percentage of On-Drug Pregnancies in Typical-Use, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule|Crude pregnancy rate is defined as the percentage of on-drug pregnancies per number of participants in each body mass index (BMI) decile (BMI range, in kg/m^2). The 7-day rule is a standardized process for calculating pregnancy rates. Seven-day rule: a pregnancy was considered “on drug” if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets.|thirteen 28-day cycles|Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. The 'Typical-use' set included PITT participants who completed at least one 28-day cycle and in which no other birth control method (BCM), including condoms, were used. n=number of participants in BMI decile group.||percentage of pregnancies|||Number
824745|NCT01178125|Secondary|Percentage of On-Drug Pregnancies in All Users, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule|Crude pregnancy rate is defined as the percentage of on-drug pregnancies per number of participants in each body mass index (BMI) decile (BMI range, in kg/m^2). The 7-day rule is a standardized process for calculating pregnancy rates. Seven-day rule: a pregnancy was considered “on drug” if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets.|thirteen 28-day cycles|Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. The 'All Users' set included PITT participants who completed at least one 28-day cycle. n=number of participants in BMI decile group.||percentage of pregnancies|||Number
824746|NCT01178125|Secondary|Percentage of On-Drug Pregnancies in Compliant-Use, by Body Weight Decile Groups Using the 7-Day Rule|Crude pregnancy rate is defined as the percentage of on-drug pregnancies per number of participants in each body weight decile (weight range, in kilograms). The 7-day rule is a standardized process for calculating pregnancy rates. Seven-day rule: a pregnancy was considered “on drug” if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets. Compliant use: did not skip 2 or more consecutive pills, had an overall compliance with IP administration of at least 80%, and did not use a prohibited medication.|thirteen 28-day cycles|Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. 'Compliant-use' set included PITT participants who completed at least 1 28-day cycle in which no other BCMs were used, and who were deemed to be compliant, per protocol. n=number of participants in body weight decile group.||percentage of pregnancies|||Number
824747|NCT01178125|Secondary|Percentage of On-Drug Pregnancies in Typical-Use, by Body Weight Decile Groups Using the 7-Day Rule|Crude pregnancy rate is defined as the percentage of on-drug pregnancies per number of participants in each body weight decile (weight range, in kilograms). The 7-day rule is a standardized process for calculating pregnancy rates. Seven-day rule: a pregnancy was considered “on drug” if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets.|thirteen 28-day cycles|Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. The 'Typical-use' set included PITT participants who completed at least one 28-day cycle and in which no other birth control method (BCM), including condoms, were used. n=number of participants in body weight decile group.||percentage of pregnancies|||Number
824773|NCT01178268|Other Pre-specified|ID-TVF Rate in Dual Lesion Treated Subgroup|ID-TVF rate in Patients with dual lesion treated during the index procedure|24 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824774|NCT01178268|Other Pre-specified|ID-TVF Rate in Single Lesion Treated Subgroup|ID-TVF rate in Patients with single lesion treated during the index procedure|24 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824748|NCT01178125|Secondary|Percentage of On-Drug Pregnancies in All Users, by Body Weight Decile Groups Using the 7-Day Rule|Crude pregnancy rate is defined as the percentage of on-drug pregnancies per number of participants in each body weight decile (weight range, in kilograms). The 7-day rule is a standardized process for calculating pregnancy rates. Seven-day rule: a pregnancy was considered “on drug” if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets.|thirteen 28-day cycles|Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. The 'All Users' set included PITT participants who completed at least one 28-day cycle. n=number of participants in the body weight decile group.||percentage of pregnancies|||Number
824749|NCT01178125|Secondary|Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight|A life table approach was used to estimate the cumulative pregnancy rate on a cycle-by-cycle basis for each of the thirteen 28-day treatment cycles. Compliant use: did not skip 2 or more consecutive pills, had an overall compliance with IP administration of at least 80%, and did not use a prohibited medication.|thirteen 28-day cycles|Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. The 'Compliant-use' set included PITT participants who completed at least one 28-day cycle and in which no other BCMs, including condoms, were used, and who were deemed to be compliant, per protocol.||pregnancies / cumulative exposure||95% Confidence Interval|Number
824750|NCT01178125|Primary|Compliant-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight, Using the 7-Day Rule|Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI) and the 7-day rule (a standardized process for calculating pregnancy rates). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-102 or > 7 days after stopping the combination DSG/EE or EE treatment of DR-102.The PI is defined as number of contraceptive failures per 100 women-years of exposure: (100)*(total number of pregnancies)*(13)/(total number of 28-day cycles). Seven-day rule: a pregnancy was considered “on drug” if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets. Compliant use: did not skip 2 or more consecutive pills, had an overall compliance with IP administration of at least 80%, and did not use a prohibited medication.|thirteen 28-day cycles|Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. 'Compliant-use' set included PITT participants who completed at least one 28-day cycle and in which no other birth control method (BCM), including condoms, were used, and who were deemed to be compliant, per protocol.||pregnancies / 100 woman years exposure|Participants|95% Confidence Interval|Number
824751|NCT01178125|Primary|Typical-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight, Using the 7-Day Rule|Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI) and the 7-day rule (a standardized process for calculating pregnancy rates). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-102 or > 7 days after stopping the combination DSG/EE or EE treatment of DR-102.The PI is defined as number of contraceptive failures per 100 women-years of exposure: (100)*(total number of pregnancies)*(13)/(total number of 28-day cycles). Seven-day rule: a pregnancy was considered “on drug” if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets.|thirteen 28-day cycles|Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. The 'Typical-use' set included PITT participants who completed at least one 28-day cycle and in which no other birth control method (BCM), including condoms, were used.||pregnancies / 100 woman years exposure|Participants|95% Confidence Interval|Number
824752|NCT01178125|Secondary|All Users Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight|A life table approach was used to estimate the cumulative pregnancy rate on a cycle-by-cycle basis for each of the thirteen 28-day treatment cycles.|thirteen 28-day cycles|Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. The 'All Users' set included PITT participants who completed at least one 28-day cycle.||pregnancies / cumulative exposure||95% Confidence Interval|Number
824753|NCT01178125|Other Pre-specified|Endometrial Biopsy Classification Results for Endometrial Tissue/Glands at Baseline and Endpoint|A subset of study participants agreed to have baseline and endpoint (Week 51/Early Withdrawal) endometrial biopsies. Results were provided for assessment of endometrial tissue/glands. Atrophic: scant or moderate amount of tissue, consists of tiny strips and wisps of surface endometrium or small tubular glands with scant or absent luminal secretions. Inactive: tubular glands lined by epithelial cells with mild pseudostratified and elongated nuclei. Proliferative: tubular or elongated glands lined by cells with elongated, dense, pseudostratified nuclei. Secretory: glands are tortuous or coiled with subnuclear vacuolation, secretion, and intraluminal tufts. Hyperplasia: proliferative type of glands showing glandular crowding with irregular shapes and sizes of enlargement, budding, and branching. Menstrual: glandular and stromal breakdown with fibrin thrombi in small vessels, condensed and collapsed stroma, and necrotic debris.|Baseline (at Enrollment), Endpoint (Week 51/Early Withdrawal)|Subset of participants with sufficient tissue at both Baseline and Endpoint biopsies.||participants|||Number
824775|NCT01178268|Other Pre-specified|ID-TVF Rate in Patients Without Diabetic Disease|ID-TVF rate in Non Diabetes|24 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824776|NCT01178268|Other Pre-specified|ID-TVF Rate in Patients With Diabetic Disease|ID-TVF rate in All Diabetes patients.|24 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824777|NCT01178268|Secondary|Acute Gain||post procedure on 0 day|The number of participants with angiographic follow up available was analysed.||Millimeter|Participants|Standard Deviation|Mean
824778|NCT01178268|Secondary|Percent Diameter Stenosis (%DS)||post procedure on 0 day|The number of participants with angiographic follow up available was analysed.||Percent Diameter stenosis|Participants|Standard Deviation|Mean
824754|NCT01178125|Other Pre-specified|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs|AEs summarized are those that began or worsened after treatment with investigational product (IP). An AE is any untoward medical occurrence in a subject or clinical investigation subject participating in a clinical study and which does not necessarily have to have a causal relationship with this treatment or clinical study. Severity of AEs was assessed as mild, moderate or severe. A severe AE was defined as incapacitating, with inability to perform usual activity. An AE was defined as treatment-related when there is reasonable possibility that the AE was caused by or attributed to the IP and/or a causal relationship cannot be ruled out. An SAE was defined as one that meets any one of the following criteria: fatal or life-threatening; requires or prolongs in-patient hospitalization; results in persistent or significant disability/incapacity; congenital anomaly/birth defect; important medical event.|Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.|Safety population (received at least 1 dose of DR-102)||participants|||Number
824755|NCT01178125|Primary|All Users Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight, Using the 7-Day Rule|Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI) and the 7-day rule (a standardized process for calculating pregnancy rates). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-102 or > 7 days after stopping the combination desogestrel/ethinyl estradiol (DSG/EE) or ethinyl estradiol (EE) treatment of DR-102.The PI is defined as number of contraceptive failures per 100 women-years of exposure: (100)*(total number of pregnancies)*(13)/(total number of 28-day cycles). Seven-day rule: a pregnancy was considered “on drug” if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets.|thirteen 28-day cycles|Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. The 'All Users' set included PITT participants who completed at least one 28-day cycle.||pregnancies / 100 woman years exposure|Participants|95% Confidence Interval|Number
824756|NCT01178138|Primary|Blood Pressure Effects of Prazosin on Methamphetamine|"Blood pressure effects of prazosin on methamphetamine;
In each session, each subject received prazosin (1 or 2 mg) or prazosin placebo. The blood pressure was measured. Then, one hour later, methamphetamine placebo or methamphetamine (20mg) was given and the blood pressure was measured again."|0 hr time point after prazosin and 1 hr time point after methamphetamine|||mmHg||Standard Deviation|Mean
824757|NCT01178138|Primary|Heart Effects of Prazosin on Methamphetamine|"Heart effects of prazosin on methamphetamine;
In each session, each subject received prazosin (1 or 2 mg) or prazosin placebo. The heart rate was measured. Then, one hour later, methamphetamine placebo or methamphetamine (20mg) was given and the heart rate was measured again."|0 hr time point after prazosin and 1 hr time point after methamphetamine|||beats per minute||Standard Deviation|Mean
824758|NCT01178138|Primary|Self-report Effects of High.|"Visual analog scales measuring effects prazosin on methamphetamine; change in methamphetamine high. Visual analog scales allow the subject to give a rating of methamphetamine effects. For instance, how high the dose makes you . The study tested how much prazosin changed the effects of methamphetamine as measured by these visual analog scales.
Visual analog scale is a 100 mm scale, ranging from 0 (no effect) to 100 (maximum effect).
In each session, each subject received prazosin (1 or 2 mg) or prazosin placebo. The visual analog scale was measured. Then, one hour later, methamphetamine placebo or methamphetamine (20mg) was given and the visual analog scale was measured again."|0 hr time point after prazosin and 1 hr time point after methamphetamine|||units on a scale||Standard Deviation|Mean
824759|NCT01178268|Other Pre-specified|ID-TLR Rate in Dual Vessel Treated Subgroup|Ischemia-driven target lesion revascularization rate in Patients with dual vessel treated during the index procedure.|24 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824760|NCT01178268|Other Pre-specified|ID-TLR Rate in Single Vessel Treated Subgroup|Ischemia-driven target lesion revascularization rate in Patients with single vessels treated during the index procedure.|24 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824761|NCT01178268|Other Pre-specified|ID-TLR Rate in Dual Lesion Treated Subgroup|Ischemia-driven target lesion revascularization rate in Patients with dual lesion treated during the index procedure|24 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824762|NCT01178268|Other Pre-specified|ID-TLR Rate in Single Lesion Treated Subgroup|Ischemia-driven target lesion revascularization rate in Patients with single lesion treated during the index procedure|24 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824763|NCT01178268|Other Pre-specified|ID-TLR Rate in Patients Without Diabetic Disease|Ischemia-driven target lesion revascularization rate in Non Diabetes|24 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824764|NCT01178268|Other Pre-specified|ID-TLR Rate in Patients With Diabetic Disease.|Ischemia-driven target lesion revascularization rate in All Diabetes patients.|24 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824765|NCT01178268|Other Pre-specified|The Composite of ST, All Death, and All MI Rate in Dual Vessel Treated Subgroup|The composite of ST, all death, and all MI rate in Patients with dual vessel treated during the index procedure.|24 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824766|NCT01178268|Other Pre-specified|The Composite of ST, All Death, and All MI Rate in Single Vessel Treated Subgroup|The composite of ST, all death, and all MI rate in Patients with single vessels treated during the index procedure.|24 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824767|NCT01178268|Other Pre-specified|The Composite of ST, All Death, and All MI Rate in Dual Lesion Treated Subgroup|The composite of ST, all death, and all MI rate in Patients with dual lesion treated during the index procedure|24 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824787|NCT01178268|Secondary|XIENCE V EECSS Excellent Overall Performance and Deliverability Using the XIENCE V EECSS Performance Evaluation Questionnaire|A related secondary performance goal for XIENCE V EECSS is the physician-determined evaluation of acute performance, deliverability, and resource utilization. XIENCE V EECSS acute performance and deliverability were determined using the XIENCE V EECSS Performance Evaluation Questionnaire. Possible responses included strongly agree,moderately agree, agree, moderately disagree, and strongly disagree. Study physicians who enrolled patients into the study were reported for this outcome measure.|During the procedure|||percentage of participants|||Number
824788|NCT01178268|Secondary|Fluoroscopy Time|This is the procedure related endpoint.|On day 0, during the procedure.|||Minutes||Standard Deviation|Median
824789|NCT01178268|Secondary|Amount of Contrast Used|Defined as total amount used from insertion of the first guiding catheter until removal of the last guiding catheter.|On day 0, during the procedure.|||Milliliter||Standard Deviation|Median
824790|NCT01178268|Secondary|Procedure Time|This is the procedure related endpoint. Procedure time is defined as time between insertion of the first guiding catheter until removal of the last guiding catheter.|On day 0, during the procedure.|||Minutes||Standard Deviation|Median
824791|NCT01178268|Secondary|Acute Procedure Success|Per-protocol procedure success is defined as the achievement of a final in-stent DS of < 50% (by online QCA or visual estimation), using the assigned device and with any adjunctive devices, and occurring without cardiac death, MI (including Q-wave or non–Q-wave), or repeat revascularization of the target lesion during the hospital stay.|< or = 1 day|||percentage of participants|||Number
824792|NCT01178268|Secondary|Acute Device Success|Per-protocol device success is defined as the achievement of a final in-stent residual diameter stenosis (DS) of < 50% by Quantitative Coronary Angiography (QCA), using only the assigned device, and occurring without a device malfunction.|< or = 1 day|||percentage of participants|Participants||Number
824793|NCT01178268|Secondary|Patient Compliance With Dual Antiplatelet Therapy (DAPT)||24 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824794|NCT01178268|Secondary|Patient Compliance With Dual Antiplatelet Therapy (DAPT)||12 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824795|NCT01178268|Secondary|Patient Compliance With Dual Antiplatelet Therapy (DAPT)||9 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824796|NCT01178268|Secondary|Patient Compliance With Dual Antiplatelet Therapy (DAPT)||6 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824797|NCT01178268|Secondary|Patient Compliance With Dual Antiplatelet Therapy (DAPT)||30 days|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824798|NCT01178268|Secondary|Definite / Probable Stent Thrombosis|Stent Thrombosis was adjudicated using Academic Research Consortium (ARC) criteria. Definite Stent Thrombosis defined as angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes suggestive of acute ischemia, typical rise and fall of cardiac biomarkers; pathological confirmation of ST through either autopsy or tissue examination following thrombectomy. Probable Stent Thrombosis defined as any unexplained death within the first 30 days or, irrespective of the time after the index procedure, any MI related to documented acute ischemia in the territory of the stent without angiographic confirmation.|Overall (0 - 772 days)|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824799|NCT01178268|Secondary|Definite / Probable Stent Thrombosis|Stent Thrombosis was adjudicated using Academic Research Consortium (ARC) criteria. Definite Stent Thrombosis defined as angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes suggestive of acute ischemia, typical rise and fall of cardiac biomarkers; pathological confirmation of ST through either autopsy or tissue examination following thrombectomy. Probable Stent Thrombosis defined as any unexplained death within the first 30 days or, irrespective of the time after the index procedure, any MI related to documented acute ischemia in the territory of the stent without angiographic confirmation.|Very late (366 – 772 days)|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824800|NCT01178268|Secondary|Definite / Probable Stent Thrombosis|Stent Thrombosis was adjudicated using Academic Research Consortium (ARC) criteria. Definite Stent Thrombosis defined as angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes suggestive of acute ischemia, typical rise and fall of cardiac biomarkers; pathological confirmation of ST through either autopsy or tissue examination following thrombectomy. Probable Stent Thrombosis defined as any unexplained death within the first 30 days or, irrespective of the time after the index procedure, any MI related to documented acute ischemia in the territory of the stent without angiographic confirmation.|Late (31 – 365 days)|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824801|NCT01178268|Secondary|Definite / Probable Stent Thrombosis|Stent Thrombosis was adjudicated using Academic Research Consortium (ARC) criteria. Definite Stent Thrombosis defined as angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes suggestive of acute ischemia, typical rise and fall of cardiac biomarkers; pathological confirmation of ST through either autopsy or tissue examination following thrombectomy. Probable Stent Thrombosis defined as any unexplained death within the first 30 days or, irrespective of the time after the index procedure, any MI related to documented acute ischemia in the territory of the stent without angiographic confirmation.|Early (0 – 30 days)|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824802|NCT01178268|Secondary|Definite / Probable Stent Thrombosis|Stent Thrombosis was adjudicated using Academic Research Consortium (ARC) criteria. Definite Stent Thrombosis defined as angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes suggestive of acute ischemia, typical rise and fall of cardiac biomarkers; pathological confirmation of ST through either autopsy or tissue examination following thrombectomy. Probable Stent Thrombosis defined as any unexplained death within the first 30 days or, irrespective of the time after the index procedure, any MI related to documented acute ischemia in the territory of the stent without angiographic confirmation.|Subacute (1 – 30 days)|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824803|NCT01178268|Secondary|Definite / Probable Stent Thrombosis|Stent Thrombosis was adjudicated using Academic Research Consortium (ARC) criteria. Definite Stent Thrombosis defined as angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes suggestive of acute ischemia, typical rise and fall of cardiac biomarkers; pathological confirmation of ST through either autopsy or tissue examination following thrombectomy. Probable Stent Thrombosis defined as any unexplained death within the first 30 days or, irrespective of the time after the index procedure, any MI related to documented acute ischemia in the territory of the stent without angiographic confirmation.|Acute (<1 day)|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824804|NCT01178268|Secondary|Major Bleeding Complications|Secondary safety endpoint.|24 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824805|NCT01178268|Secondary|Major Bleeding Complications|Secondary safety endpoint.|12 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824806|NCT01178268|Secondary|Major Bleeding Complications|Secondary safety endpoint.|9 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824807|NCT01178268|Secondary|Major Bleeding Complications|Secondary safety endpoint.|6 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824808|NCT01178268|Secondary|Major Bleeding Complications|Secondary safety endpoint.|30 days|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824809|NCT01178268|Secondary|Target Vessel Protocol MI (TV-MI)|This is one of the secondary safety endpoint.|24 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824810|NCT01178268|Secondary|Target Vessel Protocol MI (TV-MI)|This is one of the secondary safety endpoint.|12 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824811|NCT01178268|Secondary|Target Vessel Protocol MI (TV-MI)|This is one of the secondary safety endpoint.|9 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824812|NCT01178268|Secondary|Target Vessel Protocol MI (TV-MI)|This is one of the secondary safety endpoint.|6 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824813|NCT01178268|Secondary|Target Vessel Protocol MI (TV-MI)|This is one of the secondary safety endpoint.|30 days|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824814|NCT01178268|Secondary|All Protocol MI (Including Q-wave or Non–Q-wave)|This is one of the secondary safety endpoint.|24 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824815|NCT01178268|Secondary|All Protocol MI (Including Q-wave or Non–Q-wave)|This is one of the secondary safety endpoint.|12 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824816|NCT01178268|Secondary|All Protocol MI (Including Q-wave or Non–Q-wave)|This is one of the secondary safety endpoint.|9 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824817|NCT01178268|Secondary|All Protocol MI (Including Q-wave or Non–Q-wave)|This is one of the secondary safety endpoint.|6 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824818|NCT01178268|Secondary|All Protocol MI (Including Q-wave or Non–Q-wave)|This is one of the secondary safety endpoint.|30 days|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824819|NCT01178268|Secondary|All Death|This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular.|24 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824820|NCT01178268|Secondary|All Death|This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular.|12 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824821|NCT01178268|Secondary|All Death|This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular.|9 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824822|NCT01178268|Secondary|All Death|This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular.|6 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824823|NCT01178268|Secondary|All Death|This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular.|30 days|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824824|NCT01178268|Secondary|All Revascularization (TLR, TVR, and Non-TVR)|One of the Secondary Safety Endpoint was all revascularization rates (target lesion, target vessel, non-target lesion, and non-target vessel) (PCI and CABG).|24 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824825|NCT01178268|Secondary|All Revascularization (TLR, TVR, and Non-TVR)||12 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824826|NCT01178268|Secondary|All Revascularization (TLR, TVR, and Non-TVR)||9 Months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824827|NCT01178268|Secondary|All Revascularization (TLR, TVR, and Non-TVR)||6 Months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824828|NCT01178268|Secondary|All Revascularization (TLR, TVR, and Non-TVR)||30 Days|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824829|NCT01178268|Secondary|Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)||24 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824830|NCT01178268|Secondary|Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)||12 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824839|NCT01178268|Secondary|All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG)|This is one of the Secondary Composite Endpoint. All death(cardiac, vascular and non-cardiovascular), all MI, all revascularization [(target lesion revascularization (TLR), target vessel revascularization (TVR), and non-target lesion revascularization(TVR) [Percutaneous coronary intervention (PCI) and Coronary artery bypass graft(CABG)].|24 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824840|NCT01178268|Secondary|All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG)|This is one of the Secondary Composite Endpoint. All death(cardiac, vascular and non-cardiovascular), all MI, all revascularization [(target lesion revascularization (TLR), target vessel revascularization (TVR), and non-target lesion revascularization(TVR) [Percutaneous coronary intervention (PCI) and Coronary artery bypass graft(CABG)].|12 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824841|NCT01178268|Secondary|All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG)|This is one of the Secondary Composite Endpoint. All death(cardiac, vascular and non-cardiovascular), all MI, all revascularization [(target lesion revascularization (TLR), target vessel revascularization (TVR), and non-target lesion revascularization(TVR) [Percutaneous coronary intervention (PCI) and Coronary artery bypass graft(CABG)].|9 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824842|NCT01178268|Secondary|All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG)|This is one of the Secondary Composite Endpoint. All death(cardiac, vascular and non-cardiovascular), all MI, all revascularization [(target lesion revascularization (TLR), target vessel revascularization (TVR), and non-target lesion revascularization(TVR) [Percutaneous coronary intervention (PCI) and Coronary artery bypass graft(CABG)].|6 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824843|NCT01178268|Secondary|All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG)|This is one of the Secondary Composite Endpoint. All death(cardiac, vascular and non-cardiovascular), all MI, all revascularization [(target lesion revascularization (TLR), target vessel revascularization (TVR), and non-target lesion revascularization(TVR) [Percutaneous coronary intervention (PCI) and Coronary artery bypass graft(CABG)].|30 days|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824844|NCT01178268|Secondary|Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non–Q-wave) Attributed to the Target Vessel (TV)||24 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824845|NCT01178268|Secondary|Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non–Q-wave) Attributed to the Target Vessel (TV)||12 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824846|NCT01178268|Secondary|Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non–Q-wave) Attributed to the Target Vessel (TV)||9 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824847|NCT01178268|Secondary|Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non–Q-wave) Attributed to the Target Vessel (TV)||6 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824848|NCT01178268|Secondary|Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non–Q-wave) Attributed to the Target Vessel (TV)||30 days|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824849|NCT01178268|Secondary|Ischemia-driven Target Lesion Failure (ID-TLF)|This is one of the Secondary Composite Endpoints.|24 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824850|NCT01178268|Secondary|Ischemia-driven Target Lesion Failure (ID-TLF)|This is one of the Secondary Composite Endpoints.|12 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824851|NCT01178268|Secondary|Ischemia-driven Target Lesion Failure (ID-TLF)|This is one of the Secondary Composite Endpoints.|9 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824852|NCT01178268|Secondary|Ischemia-driven Target Lesion Failure (ID-TLF)|Incidence of composite of cardiac death, MI attributed to the TV and ID-TLR|6 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824853|NCT01178268|Secondary|Ischemia-driven Target Lesion Failure (ID-TLF)|Incidence of composite of cardiac death, MI attributed to the TV and ID-TLR|30 days|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824854|NCT01178268|Secondary|Ischemia-driven Target Lesion Revascularization (ID-TLR) (Percutaneous Coronary Intervention [PCI] and Coronary Artery Bypass Graft [CABG])|The is the major Secondary Efficacy Endpoint.|12 months|The number of participants with angiographic follow up available was analysed.||percentage of participants||95% Confidence Interval|Number
824855|NCT01178268|Secondary|Incidence of Composite of Stent Thrombosis (ST)(Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non–Q-wave)||24 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824856|NCT01178268|Secondary|Incidence of Composite of Stent Thrombosis (ST)(Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non–Q-wave)||9 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824857|NCT01178268|Secondary|Incidence of Composite of Stent Thrombosis (ST)(Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non–Q-wave).||6 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824858|NCT01178268|Secondary|Incidence of Composite of Stent Thrombosis (ST)(Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non–Q-wave).||30 days|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824859|NCT01178268|Secondary|Ischemia-driven Target Vessel Failure (ID-TVF)|Incidence of composite of cardiac death, all MI (including Q-wave and non– Q-wave), and ID target vessel revascularization (ID-TVR) (TLR and non-TLR in the TV [PCI and CABG])|24 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824860|NCT01178268|Secondary|Ischemia-driven Target Vessel Failure (ID-TVF)|Incidence of composite of cardiac death, all MI (including Q-wave and non– Q-wave), and ID target vessel revascularization (ID-TVR) (TLR and non-TLR in the TV [PCI and CABG])|9 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824861|NCT01178268|Secondary|Ischemia-driven Target Vessel Failure (ID-TVF)|Incidence of composite of cardiac death, all MI (including Q-wave and non– Q-wave), and ID target vessel revascularization (ID-TVR) (TLR and non-TLR in the TV [PCI and CABG]).|6 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824862|NCT01178268|Secondary|Ischemia-driven Target Vessel Failure (ID-TVF)|Incidence of composite of cardiac death, all MI (including Q-wave and non– Q-wave), and ID target vessel revascularization (ID-TVR) (TLR and non-TLR in the TV [PCI and CABG])|30 days|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
824863|NCT01178268|Primary|Incidence of Composite of ST (Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non–Q-wave)|The primary composite safety endpoint was the incidence of the composite of ST (definite and probable), all death (cardiac, vascular and non-cardiovascular), and all MI (including Q-wave and non–Q-wave).|12 months|The number of participants with angiographic follow up available was analysed.||percentage of participants||95% Confidence Interval|Number
824864|NCT01178268|Primary|Ischemia-driven Target Vessel Failure (ID-TVF)|This is the primary efficacy endpoint. Ischemia-driven target vessel failure is defined as the composite of cardiac death, all myocardial infarction (MI) and ischemia-driven target vessel revascularization (ID-TVR).|12 months|The number of participants with angiographic follow up available was analysed.||percentage of participants||95% Confidence Interval|Number
824865|NCT01178268|Primary|In-stent Late Loss (LL)|"This is the primary angiographic endpoint.
In-stent LL: The difference between the minimum lumen diameter (MLD) immediately after stent deployment and the MLD at follow-up (within stent)"|>=13 months|The number of participants with angiographic follow up available was analysed.||Millimeter|Participants|Standard Deviation|Mean
824866|NCT01178281|Secondary|Overall Survival|The time from randomization to the death or to the latest date when participants are known to be alive.|Up to 2.5 years||08/2018||||
824867|NCT01178281|Secondary|Frequency of Adverse Events|An Adverse Event (AE) is any noxious, unintended or untoward medical occurrence that may appear or worsen in a participant during the course of a study.|Up to 2.5 years||08/2018||||
824868|NCT01178281|Secondary|FACT-Anemia Quality of Life Questionaire|The FACT-An questionnaire is a cancer-specific questionnaire measuring the four general domains of quality-of-life and an additional anemia questionnaire.|Up to treatment discontinuation||08/2018||||
824869|NCT01178281|Secondary|Euro QOL 5 Dimension Questionaire|The EQ-5D is a standardized instrument that measures health outcomes for a wide range of health conditions.|Up to treatment discontinuation||08/2018||||
824870|NCT01178281|Secondary|Healthcare Resource Utilization|"Characterization of medical resource utilization among participants treated with pomalidomide as compared to subjects receiving placebo treatment.
Information on the length of each hospitalization and other major outpatient resource use will be collected at designated study visits, including major diagnostic procedures and other interventions such as those required for transfusions or for treatment-related adverse events. Additionally, information on major categories of concomitant medications (eg., use of G-CSF, intravenous antibiotics, anti-virals, iron chelation) will be obtained."|Every 28 days||08/2018||||
824871|NCT01178281|Secondary|Time to Becoming RBC-transfusion-independent|Number of days from randomization to achieving RBC transfusion independence as assessed every 28 days.|Up to 2.5 years||08/2018||||
824872|NCT01178281|Secondary|Duration of RBC-transfusion Independence|Number of days from randomization to achieving RBC transfusion independence as assessed every 28 days.|Up to 2.5 years||08/2018||||
824873|NCT01178281|Primary|Percentage of Participants Who Achieved Red Blood Cell (RBC) Transfusion Independence|"Defined as the absence of intravenous RBC transfusions for any consecutive rolling 84 day interval (i.e. days 1 to 84, days 2 to 85 etc) before Day 169 visit. A responder is: a. One who received at least two RBC transfusions on/after the first dose of study drug, and at least one ≥ 84 days between two consecutive RBC-transfusions; b. One who received at least one RBC transfusion after the first dose of study drug and no RBC transfusion at the first study drug day, and the time interval between the first dose of study drug and the RBC transfusion date is ≥ 84 days; c. One who received at least one RBC transfusion on/after the first dose of study drug and the time interval between the last RBC transfusion and the last transfusion assessment date is ≥ 84 days; d. One who did not receive any RBC transfusions on and after the first dose of study drug, and the time interval between the first dose of study drug and the date of the last transfusion assessment is ≥ 84 days"|168 days|Intent to Treat Population (ITT) includes all participants that were randomized to either of the two study drugs, regardless of whether or not any study drug was actually taken.||percentage of participants||95% Confidence Interval|Number
826070|NCT01195701|Secondary|Total Testosterone|Free & total testosterone, and the calculated free androgen index will be compared; additionally, these levels will be correlated with the questionnaire data and clitoral measurements|Between day 1-14 (follicular phase) of menstrual cycle|||ng/dL||Inter-Quartile Range|Median
824892|NCT01178333|Secondary|Time to Platelet Recovery, Among Subjects With a Low Platelet Count When the Positive PF4 Antibody Test Was Drawn||From the time that the nadir platelet count was drawn until hospital discharge, death, or day 45, whichever occurred first|||days||Standard Error|Mean
824893|NCT01178333|Secondary|Use of Treatment (Non-heparin Anticoagulant) Used at the Time of Discharge||From the time that the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first|||participants|||Number
824894|NCT01178333|Primary|Time to Occurrence of a Composite Triple Endpoint Consisting of Death, Limb Amputation/Gangrene, and New Thrombosis|The median survival time is reported by each group for the time to occurrence of a composite triple endpoint consisting of death, limb amputation/gangrene, and new thrombosis.|From the time that the positive heparin PF-4 antibody test was drawn until hospital discharge or day 45, whichever occurred first.|||days||95% Confidence Interval|Median
824895|NCT01178333|Primary|Time to Occurrence of a Composite Triple Endpoint Consisting of Death, Limb Amputation/Gangrene, and New Thrombosis|The mean time to an event is estimated by the area under the survival function. If the largest time is an event time, then the survival function goes to zero at that time, and the mean survival estimate is finite. Otherwise, the mean time cannot be estimated and may lead to a bias.|From the time that the positive heparin PF-4 antibody test was drawn until hospital discharge or day 45, whichever occurred first.|||days||Standard Error|Mean
824896|NCT01178333|Secondary|Use of Treatment (Non-heparin Anticoagulant) Used in Hospital|Types of treatment (direct thrombin inhibitor, fondaparinux, warfarin, no treatment) provided to subjects in hospital|From the time that the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first|||participants|||Number
824897|NCT01178333|Secondary|Relationship of the Heparin PF-4 Antibody Titer to the Primary Endpoint|Heparin PF-4 OD test results were the dichotomous outcome (<1.0 vs. >=1.0). Primary endpoint was the composite endpoint of death, limb amputation/gangrene, or new thrombosis.|From the time the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first|||participants|||Number
824898|NCT01178333|Secondary|Relationship of the Heparin PF-4 Antibody Titer to the Degree of Thrombocytopenia|Heparin PF-4 optical density (OD) test results were the dichotomous outcome (<1.0 vs. >=1.0). Nadir Platelet Count (x10^9 / L) was used for the degree of thrombocytopenia. The Heparin PF-4 optical density test looks for antibodies to complexes of heparin combined with platelet factor 4. Higher optical density indicates higher antibody concentration. We could say that generally OD values above 0.4 are considered a positive result, and that the higher the OD, the greater the concentration of antibodies in the patient's blood.|From the time the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first|||X10^9 / L||Standard Deviation|Mean
824899|NCT01178333|Secondary|Relationship of the Heparin PF-4 (Platelet Factor 4) Antibody Titer to the Clinical Diagnosis|Heparin PF-4 (platelet factor 4) optical density (OD) test results were the dichotomous outcome (<1.0 vs. >=1.0). Clinical diagnosis was three groups (HIT-T, Isolated HIT and No HIT). The Heparin PF-4 optical density test looks for antibodies to complexes of heparin combined with platelet factor 4. Higher optical density indicates higher antibody concentration. We could say that generally OD values above 0.4 are considered a positive result, and that the higher the OD, the greater the concentration of antibodies in the patient's blood.|From the time the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first|There was one missing data for optical density test results in Isolated HIT group. Therefore, 283 subjects were used for Isolated HIT group.||participants|||Number
824900|NCT01178333|Secondary|Type of Heparin Exposure - Low Molecular Weight Heparin (LMWH)|Two types of heparins are commonly used as anticoagulants - unfractionated heparin (UFH) and low-molecular-weight heparin (LMWH). LMWHs are derived from UFH by depolymerization. Each LMWH product has a specific molecular weight distribution that determines its anticoagulant activity and duration of action.|Hospital admission to date the positive heparin PF-4 antibody test was drawn, or 28 days prior to the date it was drawn, whichever is later, through the date it was drawn|||participants|||Number
824901|NCT01178333|Secondary|Type of Heparin Exposure - Unfractionated Heparin (UFH)|Two types of heparins are commonly used as anticoagulants - unfractionated heparin (UFH) and low-molecular-weight heparin (LMWH). UFH has been used for the prevention and treatment of thrombosis for several decades.|Hospital admission to date the positive heparin PF-4 antibody test was drawn, or 28 days prior to the date it was drawn, whichever is later, through the date it was drawn|||participants|||Number
824902|NCT01178333|Secondary|Proportion of Subjects With HIT With Thrombosis (HIT-T) and Isolated HIT|"Proportion of subjects who, at the time the positive heparin PF-4 antibody test was drawn, were in each of the following categories:
Group 1: Those with thrombosis and or without thrombocytopenia (HIT-T): 16% of 442 subjects.
Group 2: Those with thrombocytopenia but not thrombosis (Isolated HIT): 64% of 442 subjects.
Group 3: Those with neither thrombocytopenia nor thrombosis (Neither HIT-T nor Isolated HIT): 20% of 442 subjects."|From the date 5 days before the positive heparin PF-4 antibody test was drawn to the date it was drawn|||participants|||Number
824903|NCT01178333|Secondary|Time to Occurrence of Major Bleeding|The median survival time is reported by each group for the time to occurrence of major bleeding.|From the time that the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first|||days||95% Confidence Interval|Median
825294|NCT01181726|Primary|AUC0-inf of Corrected Total Estrone(Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on Corrected Total Estrone AUC0-inf.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
824904|NCT01178333|Secondary|Time to Occurrence of Major Bleeding|The mean time to an event is estimated by the area under the survival function. If the largest time is an event time, then the survival function goes to zero at that time, and the mean survival estimate is finite. Otherwise, the mean time cannot be estimated and may lead to a bias.|From the time that the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first|||days||Standard Error|Mean
824905|NCT01178333|Secondary|Time to Occurrence of Radiographically Confirmed Thromboembolism|"The mean time to an event is estimated by the area under the survival function. If the largest time is an event time, then the survival function goes to zero at that time, and the mean survival estimate is finite. Otherwise, the mean time cannot be estimated and may lead to a bias. However, the median survival times could not be defined for all three groups, so the mean time was reported in Outcome Measure Data Table."|From the time the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first|||days||Standard Error|Mean
824906|NCT01178333|Secondary|Time to Occurrence of Limb Amputation or Limb Gangrene|"Due to the small number of events, the median or mean survival time could not be defined. Therefore, the number of subjects with limb amputation or limb gangrene was reported in Outcome Measure Data Table."|From the time the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first|||participants|||Number
824907|NCT01178333|Secondary|Time to Death|The median survival time is reported by each group for the time to death.|From the time the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first|||days||95% Confidence Interval|Median
824908|NCT01178333|Secondary|Time to Death|The mean time to an event is estimated by the area under the survival function. If the largest time is an event time, then the survival function goes to zero at that time, and the mean survival estimate is finite. Otherwise, the mean time cannot be estimated and may lead to a bias.|From the time the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first|||days||Standard Error|Mean
824909|NCT01178385|Secondary|Clinical Global Impression - Severity Scale (This Scale Measures the Severity of the Child's Anxiety Symptoms).|This scale measures severity of the child's overall anxiety presentation. The minimum rating is 0, the maximum is 6. Higher scores correspond to greater anxiety; lower scores correspond to less severe anxiety. There are no subscales for this measure.|After an average of 16 weeks (Post-treatment)|||units on a scale||Standard Deviation|Mean
824910|NCT01178385|Secondary|Anxiety Disorders Interview Schedule Highest Anxiety Clincian Severity Rating (Measures the Severity of the Child's Anxiety Symptoms)|This is a measure of severity of the child's primary anxiety disorder. The maximum rating is 8, the minimum rating is 0. Higher scores correspond to more severe anxiety.|After an average of 16 weeks (Post-treatment)|||units on a scale||Standard Deviation|Mean
824911|NCT01178385|Primary|Pediatric Anxiety Rating Scale (Measures the Severity of Anxiety Symptoms)|This scale assesses the severity of anxiety symptoms. The scale ranges from 0 (minimum score) to 25 (maximum score). Higher scores reflect more severe anxiety symptoms; lower scores reflect lower anxiety severity. There are no subscales to this measure.|After an average of 16 weeks (Post-treatment)|||units on a scale||Standard Deviation|Mean
824912|NCT01178528|Secondary|New York Heart Association (NYHA) Class|"The 1994 NYHA Classification system is a measure of functional status. It was designed for clinical assessment of patients by physicians as NYHA class I, II, III, or IV, on the basis of patient’s limitations in physical activities caused by cardiac symptoms.
Class I describes patients with cardiovascular disease (CVD) but without resulting limitation of physical activity. There is no objective evidence of CVD.
Class II describes patients with CVD resulting in slight limitation of physical activity. There is objective evidence of minimal CVD.
Class III describes patients with CVD resulting in marked limitation of physical activity. There is objective evidence of moderately severe CVD.
Class IV describes patients with CVD resulting in inability to carry on any physical activity without discomfort. There is objective evidence of severe CVD.
Here we report data on number of patients showing an improvement by at least one NYHA class according to treatment allocation."|3 months|||participants|||Number
824913|NCT01178528|Primary|Maximal Oxygen Consumption|Functional capacity was assessed by means of a cardiopulmonary exercise test with a bicycle ergometer with gas exchange monitoring (Vmax 29 C, SensorMedics). Peak oxygen consumption was defined as the maximal oxygen consumption (MVO2) observed during exercise.|3 months|||mL/Kg/min||Standard Deviation|Mean
824914|NCT01178528|Secondary|Quality of Life|Quality of life (QoL) was evaluated using the Visual Analogue Scale (VAS) which is a global measurement of QoL, allowing a subjective assessment of the impact of the disease and treatment. Patients are asked to indicate their current state in a line from 0 (worst state) to 10 (best state), with higher values therefore representing a better outcome.|3 months|||units on a scale||Standard Deviation|Mean
824915|NCT01178528|Primary|Exercise Tolerance Assessed by 6 Minute Walking Test|"Distance measured at 6 minute walking test. The 6 minute walking test was performed according to standardised procedure at baseline, before inclusion (at least 1 week after baseline evaluation), and at the end of the study. Patients who had not done at least two tests in the past underwent two practice 6 minute walking tests at least 3 days apart. Results are expressed in terms of distance walked (metres). The test was supervised by a physical therapist.
Patients were asked to walk at their own maximal pace a 100 m long hospital corridor. At the beginning of the last (6th) minute of the test a standard phrase of encouragement was told. Patients were allowed to stop if signs or symptoms of significant distress occurred (dyspnea, angina), through they were instructed to resume walking as soon as possible."|3 months|||meters||Standard Deviation|Mean
824916|NCT01178671|Secondary|Sexual Functioning|as measured by Arizona Sexual Experiences Scale, which rates impairment in sexual functioning from 5 (least impaired) to 30 (most impaired).|up to 24 weeks|intent to treat||units on a scale||Standard Deviation|Mean
824917|NCT01178671|Secondary|Sleep Quality|as measured by Pittsburgh Sleep Quality Index, which rates severity of impairment in sleep quality from 0 (least impaired) to 21 (most impaired).|up to 24 weeks|intent to treat||units on a scale||Standard Deviation|Mean
824918|NCT01178671|Secondary|Adverse Effects|as assessed by Side Effect Checklist|up to 24 weeks|intent to treat||percentage of subject dropped due to AEs|||Number
824919|NCT01178671|Secondary|Remission Status|Remitter as defined by Clinician Administered Posttraumatic Stress Disorders Scale total score <20 at endpoint|up to 24 weeks|intent to treat||percentage of subjects|||Number
824926|NCT01178762|Primary|Total Number of Participants With Negative Chlamydia Direct Fluorescent Antibody (DFA) Test Results After Oral Azithromycin Treatments|We performed direct fluorescent antibody (DFA) tests for Chlamydia by swabbing across the lower and upper tarsal conjunctiva four times after topical application of 0.5% proparacaine. All of the DFA tests were examined by the same experienced microbiologist who was masked to the identities and clinical conditions of the patients. Each DFA slide was read under a fluorescent microscope and was observed for discrete fluorescent chlamydial elementary bodies (EBs).The DFA test was considered positive if above 10 EBs were counted per high-power field.|4 weeks, 8 weeks and 12 weeks after the first dose of the medication|Only participants with confirmed DFA tests are counted in the results below. Participants with confirmed negative DFA tests subsequently stopped treatment and were not retested. Participants lost to follow-up are counted as not having a confirmed DFA negative test||participants|||Number
824927|NCT01178827|Secondary|Change From Baseline in Delayed Recall Score as Measured by the BVMT-R up to Day 10|Change from Baseline in delayed recall score as measured by the BVMT-R up to Day 10. The BVMT-R is an instrument used to measure visual learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition trial. The total recall score is the sum of 3 free recall learning trials, and reflects the patient’s ability to learn. The total score ranges from 0 (no memory) to 12 (best memory). A positive change from baseline indicates improved memory.|Baseline, 10 Days|Per Protocol: All subjects who completed the study.||Scores on a Scale||Standard Deviation|Mean
824928|NCT01178827|Secondary|Change From Baseline in Total Recall Score as Measured by the Brief Visuospatial Memory Test-Revised (BVMT-R) up to Day 10|Change from Baseline in total recall score as measured by the BVMT-R up to Day 10. The BVMT-R is an instrument used to measure visual learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition trial. The total recall score is the sum of 3 free recall learning trials, and reflects the patient’s ability to learn. The total score ranges from 0 (no memory) to 36 (best memory). A positive change from baseline indicates improved memory.|Baseline, 10 Days|Per Protocol: All subjects who completed the study.||Scores on a Scale||Standard Deviation|Mean
824929|NCT01178827|Secondary|Change From Baseline in Delayed Recall Score as Measured by the HVLT-R up to Day 10|Change from Baseline in Delayed Recall Score as Measured by the HVLT-R up to Day 10. The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition. The total recall score was the sum of 3 ‘free recall’ learning trials, and reflects the patient’s ability to learn. The total score ranges from 0 (no memory) to 12 (best memory). A positive change from baseline indicates improved memory.|Baseline, 10 Days|Per Protocol: All subjects who completed the study.||Scores on a Scale||Standard Deviation|Mean
824930|NCT01178827|Secondary|Change From Baseline in Total Recall Score as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R) up to Day 10|Change from Baseline in Total Recall Score as Measured by the HVLT-R up to Day 10. The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition. The total recall score was the sum of 3 ‘free recall’ learning trials, and reflects the patient’s ability to learn. The total score ranges from 0 (no memory) to 36 (best memory). A positive change from baseline indicates improved memory and a negative change from baseline indicates worsened memory.|Baseline, 10 Days|Per Protocol: All subjects who completed the study.||Scores on a Scale||Standard Deviation|Mean
824931|NCT01178827|Secondary|Plasma Levels of Oxybutynin and N-Desethyl-Oxybutynin at Day 2 Post-dose|Plasma levels of Oxybutynin and N-Desethyl-Oxybutynin (metabolite of Oxybutynin) at Day 2 post-dose. Plasma is the liquid component of the blood in which the blood cells are suspended. Plasma samples were collected from each patient and analyzed for the drug the patient received.|Day 2 Post-Dose|All patients who received of Oxybutynin IR||Nanograms (ng) per milliliter (mL)||Standard Deviation|Mean
824932|NCT01178827|Secondary|Plasma Levels of Sanctura XR® at Day 10 Post-dose|Plasma levels of Sanctura XR® at Day 10 post-dose. Plasma is the liquid component of the blood in which the blood cells are suspended. Plasma samples were collected from each patient and analyzed for the drug the patient received.|Day 10 Post-Dose|All patients who received of Sanctura XR®||Nanograms (ng) per milliliter (mL)||Standard Deviation|Mean
824933|NCT01178827|Primary|Cerebral Spinal Fluid Levels of Oxybutynin and N-Desethyl-Oxybutynin at Day 2 Post-dose|Cerebral spinal fluid levels of Oxybutynin and N-Desethyl-Oxybutynin (metabolite of Oxybutynin) at Day 2 Post-dose. Cerebral spinal fluid is the fluid that surrounds the spinal cord and the inside of the brain. Samples were drawn from patients who received Oxybutynin IR.|Day 2 Post-Dose|All patients who received Oxybutynin IR||Nanograms (ng) per milliliter (mL)||Standard Deviation|Mean
824934|NCT01178827|Primary|Cerebral Spinal Fluid Levels of Sanctura XR® at Day 10 Post-dose|Cerebral spinal fluid levels of Sanctura XR® at Day 10 Post-dose. Cerebral spinal fluid is the fluid that surrounds the spinal cord and the inside of the brain. Samples were drawn from patients who received Sanctura XR®.|Day 10 Post-Dose|All patients who received Sanctura XR®||Nanograms (ng) per milliliter (mL)||Standard Deviation|Mean
824935|NCT01178853|Primary|Percent Mean Change From Baseline of International Normalized Ratio (INR)|INR is the ratio of a patient's prothrombin time to a standard, raised to the power of the ISI value for the tissue factor reagent used (INR = (PT-Test/PT-Normal)^ISI)|22 Days|||percent change||Standard Deviation|Mean
824936|NCT01184755|Primary|Change in Systolic and Diastolic BP Measured by Ambulatory BP Monitoring (Waking Averages)|The primary outcome for this study is the change in systolic and diastolic BP measured by Ambulatory BP monitoring at 8-weeks. The measure is the waking mean BP.|8 weeks|These were patients who completed both the baseline and 8-week Ambulatory BP measures.||mm Hg||Standard Deviation|Mean
824937|NCT01184846|Secondary|Number of Subjects With Normal/Abnormal Not Clinically Significant (ANCS) Value at Baseline Changing to Abnormal Clinically Significant (ACS) Value at Completion Visit in Routine Laboratory Parameters.|Number of subjects with changes from normal/ANCS values at baseline to ACS values at Completion Visit in routine laboratory parameters including hematology and serum chemistry analytes. Investigators flagged each laboratory value as normal, ANCS or ACS at each assessment timepoint.|At Day 1 (baseline) and at Completion Visit (Week 25 or early discontinuation)|The SDS comprised all subjects treated with the study drug.||participants|||Number
831482|NCT01246076|Secondary|Time to Discontinuation of Treatment||Up to 56 weeks (14 cycles)|16 out of 24 participants were evaluable for this outcome measure as these 16 participants completed at least the first cycle of treatment.||cycles||Full Range|Median
824938|NCT01184846|Secondary|Mean Change in Body Temperature During Infusion|Body temperature was measured before the start of IgPro10 infusion, at 30 minutes and 1 hour after the start of infusion, then every hour until the end of infusion and at 1 hour after the end of infusion. Mean changes from the pre-infusion value to each of the post-infusion values were calculated for each infusion, and the mean value and SD of these individual mean changes is reported.|At Days 1 to 5 and at Weeks 4, 7, 10, 13, 16, 19 and 22.|The SDS comprised all subjects treated with the study drug.||°C||Standard Deviation|Mean
824939|NCT01184846|Secondary|Mean Change in Pulse Rate During Infusion|Pulse rate was measured before the start of IgPro10 infusion, at 30 minutes and 1 hour after the start of infusion, then every hour until the end of infusion and at 1 hour after the end of infusion. Mean changes from the pre-infusion value to each of the post-infusion values were calculated for each infusion, and the mean value and SD of these individual mean changes is reported.|At Days 1 to 5 and at Weeks 4, 7, 10, 13, 16, 19 and 22.|The SDS comprised all subjects treated with the study drug||beats per minute||Standard Deviation|Mean
824940|NCT01184846|Secondary|Mean Change in Systolic and Diastolic Blood Pressure During Infusion|Systolic and diastolic blood pressure (BP) were measured before the start of IgPro10 infusion, at 30 minutes and 1 hour after the start of infusion, then every hour until the end of infusion and at 1 hour after the end of infusion. Mean changes from the pre-infusion value to each of the post-infusion values were calculated for each infusion, and the mean value and standard deviation (SD) of these individual mean changes is reported.|At Days 1 to 5 and at Weeks 4, 7, 10, 13, 16, 19 and 22.|The SDS comprised all subjects treated with the study drug.||mm Hg||Standard Deviation|Mean
824941|NCT01184846|Secondary|Relatedness of AEs Per Subject|The causal relationship of an AE to the study drug was to be assessed and assigned by the investigator.|For the duration of the study, up to 34 weeks|The SDS comprised all subjects treated with the study drug.||percentage of subjects|||Number
824942|NCT01184846|Secondary|Relatedness of AEs Per Infusion|The causal relationship of an AE to the study drug was to be assessed and assigned by the investigator.|For the duration of the study, up to 34 weeks|The SDS comprised all subjects treated with the study drug.||AE rate per infusion|Participants||Number
824943|NCT01184846|Secondary|Severity of AEs Per Subject|"The severity of each AE was to be graded by the investigator as follows:
Mild: Symptoms were easily tolerated and there was no interference with daily activities.
Moderate: Discomfort enough to cause some interference with daily activities.
Severe: Incapacitating with inability to work or do usual activity."|34 weeks|The SDS comprised all subjects treated with the study drug.||percentage of subjects|||Number
824944|NCT01184846|Secondary|Severity of AEs Per Infusion|"The severity of each AE was to be graded by the investigator as follows:
Mild: Symptoms were easily tolerated and there was no interference with daily activities.
Moderate: Discomfort enough to cause some interference with daily activities.
Severe: Incapacitating with inability to work or do usual activity."|For the duration of the study, up to 34 weeks|The SDS comprised all subjects treated with the study drug.||AE rate per infusion|Participants||Number
824945|NCT01184846|Secondary|Frequency of Adverse Events (AEs)|Overall rate of AEs per infusion.|For the duration of the study, up to 34 weeks|The safety data set (SDS) comprised all subjects treated with the study drug.||AE rate per infusion|Participants||Number
824946|NCT01184846|Secondary|Immunoglobulin G (IgG) Level||At baseline and at Weeks 7, 13 and 19 (levels determined immediately before and after IVIG infusion), and at completion visit (Week 25)|The FAS includes all subjects who received at least one dose of IgPro10, regardless of whether or not the subject recorded an efficacy variable measurement.||mg/dL||Standard Deviation|Mean
824947|NCT01184846|Secondary|Change in Medical Research Council Sum Scale (MRC)|"The change in MRC sum score was determined at the completion visit compared to baseline and to the last measurement under the previous IVIG treatment using a non-parametric analysis to calculate the Hodges-Lehmann point estimate and the corresponding Tukey confidence interval on an exploratory basis.
The 80-point MRC sum score is the sum of scores for eight bilateral (left and right side) muscle groups, each rated between 0 (no visible contraction) to 5 (normal movement). A higher MRC sum score indicates greater muscle contraction/limb movement. Positive values for change in MRC sum score indicate improvement, with a more positive value indicating greater muscle contraction/ limb movement compared with the value at baseline."|Up to 34 weeks|The FAS includes all subjects who received at least one dose of IgPro10, regardless of whether or not the subject recorded an efficacy variable measurement. Analysed subgroups include all subjects and IVIG-pretreated and IVIG-untreated subjects from baseline to completion, and IVIG-pretreated subjects from last IVIG treatment to completion.||score on a scale||95% Confidence Interval|Mean
824948|NCT01184846|Secondary|Change in Maximum Grip Strength|Change in maximum grip strength of the dominant hand. A non-parametric analysis was used to calculate the Hodges-Lehmann point estimate and the corresponding Tukey confidence interval on an exploratory basis. Positive values for change in maximum grip strength indicate improvement.|Up to 34 weeks|The FAS includes all subjects who received at least one dose of IgPro10, regardless of whether or not the subject recorded an efficacy variable measurement. Analysed subgroups include all subjects and IVIG-pretreated and IVIG-untreated subjects from baseline to completion, and IVIG-pretreated subjects from last IVIG treatment to completion.||kPa||95% Confidence Interval|Mean
824949|NCT01184846|Secondary|Change in Adjusted INCAT Score|"The change in INCAT score was determined at the completion visit compared to baseline and to the last measurement under the previous IVIG treatment using a non-parametric analysis to calculate the Hodges-Lehmann point estimate and the corresponding Tukey confidence interval on an exploratory basis.
The INCAT disability score ranges from 0 to 10 and is the sum of arm and leg disability each rated between 0 and 5 (where arm = 0 indicates ‘no upper limb problems’ and arm = 5 indicates ‘inability to use either arm for any purposeful movement’, and leg = 0 indicates ‘walking not affected’, and leg = 5 indicates ‘restricted to wheelchair, unable to stand and walk a few steps with help’). Thus, a higher INCAT disability score indicates greater disability. Negative values for change in INCAT score indicate improvement, with a more negative value indicating greater improvement compared with the value at baseline."|Up to 34 weeks|The FAS includes all subjects who received at least one dose of IgPro10, regardless of whether or not the subject recorded an efficacy variable measurement. Analysed subgroups include all subjects and IVIG-pretreated and IVIG-untreated subjects from baseline to completion, and IVIG-pretreated subjects from last IVIG treatment to completion.||score on a scale||95% Confidence Interval|Mean
831483|NCT01246076|Secondary|Duration of Response||Until 6 months after end of treatment|8 participants had a response -- all had MCR.||days||Full Range|Median
824950|NCT01184846|Primary|Responder Rate|"Percentage of responders based on the adjusted Inflammatory Neuropathy Cause and Treatment Scale (INCAT) score.
Responders were defined as those subjects who: 1) demonstrated a “clinically meaningful improvement” between baseline and Week 25, or 2) who were discontinued from the study for any reason after the start of IgPro10 treatment but with “clinically meaningful improvement” at the last study visit.
Clinically meaningful improvement” was a decrease of at least 1 adjusted INCAT score point excluding an improvement of one point in the total score if this improvement was only due to a decrease in the upper limb score of 1 to 0."|25 weeks|The full analysis set (FAS) includes all subjects who received at least one dose of IgPro10, regardless of whether or not the subject recorded an efficacy variable measurement. The valid cases set (VCS) consists of all FAS subjects without any major protocol deviation (ie, the subjects who participated in the study as intended).||percentage of responders||95% Confidence Interval|Number
824951|NCT01184859|Secondary|Participant Counts of Minimum Observed Serum Sodium Levels During the Second Treatment Period (Days 4-32)|Serum sodium levels were monitored throughout the trial as part of the clinical chemistry panel. If the value was ≤125 mEq/L, the participant was to be withdrawn from the trial and treatment stopped immediately. This outcome reports participants' lowest recorded serum sodium levels during the second treatment period.|Days 4- 32|Safety population which included all randomised and exposed participants. Participants were analysed according to the actual treatment received.||participants|||Number
824952|NCT01184859|Secondary|Change From Baseline in Sleep Related Quality of Life Based on the Global Score of the Pittsburgh Sleep Quality Index (PSQI) at Approximately Day 32|The Global Score of the Pittsburgh Sleep Quality Index (PSQI) is comprised of Questions 2-9 with a total scale of 0 (no difficulty sleeping) to 21 (severe difficulty). The change in Global Score is Global Score at the end of period 2 (day 32) - Global Score at the start of Period 2 (day 4). A negative change indicates an improvement in quality of life.|Approximately Day 4 (start of period 2) and Day 32|Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance. Missing values post baseline were imputed using last observation carried forward (LOCF) where at least one post baseline measurement was available at a visit before the missing observation.||units on a scale||Standard Deviation|Mean
824953|NCT01184859|Secondary|Change From Baseline in Nocturia-Related Quality of Life Based on Evaluation Provided by Nocturia Quality of Life Questionnaire (N-QoL) at Approximately Day 32|N-QoL assesses the impact of nocturia on quality of life (QoL) and treatment outcomes. N-QoL is a self-administered questionnaire with 13 items using scales of 0 = no negative impact to QoL to the upper number = signficant negative impact to QoL. The sleep/energy domain consists of 7 questions with a scale of 0 to 28. The bother/concern domain consists of 5 questions for a scale of 0 to 20. The 13th question is an overall assessment scored from 0 to 10. The Total Score includes all 13 questions with a scale of 0 (no negative impact to QoL) to 58 (significant negative impact to QoL).|Approximately Day 4 (start of period 2) and Day 32|Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance. Missing values post baseline were imputed using last observation carried forward (LOCF) where at least one post baseline measurement was available at a visit before the missing observation.||units on a scale||Standard Deviation|Mean
824954|NCT01184859|Secondary|Change From Baseline in Nocturnal Polyuria Index at Approximately Day 32|Nocturnal polyuria index is defined as a proportion of nocturnal urine volume to the 24-hour urine volume. Urine volume and time of day of those voids was recorded over three consecutive days per week in diaries kept by study participants. The average nocturnal polyuria index of the 3 days recorded in the last week of the study (between study days 25-32) was compared to the average baseline readings.|3 days between study days -6 to 0 (Baseline), and days 25 to 32|Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance. Missing values post baseline were imputed using last observation carried forward (LOCF) where at least one post baseline measurement was available at a visit before the missing observation.||nocturnal urine volume / 24-hour urine||Standard Deviation|Mean
824955|NCT01184859|Secondary|Change From Baseline in 24-Hour Urine Production Per Body Weight at Approximately Day 32|Twenty-four hour urine volume was recorded over three consecutive days per week in diaries kept by study participants. Urine volume per body weight was calculated. The average 24-hour urine volume per kg of body weight of the 3 days recorded in the last week of the study (between study days 25-32) was compared to the average baseline readings.|3 days between study days -6 to 0 (Baseline), and days 25 to 32|Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance. Missing values post baseline were imputed using last observation carried forward (LOCF) where at least one post baseline measurement was available at a visit before the missing observation.||ml/kg||Standard Deviation|Mean
824956|NCT01184859|Secondary|Change From Baseline in 24-Hour Urine Volume at Approximately Day 32|Twenty-four hour urine volume was recorded over three consecutive days per week in diaries kept by study participants. The average 24-hour urine volume of the 3 days recorded in the last week of the study (between study days 25-32) was compared to the average baseline readings.|3 days between study days -6 to 0 (Baseline), and days 25 to 32|Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance. Missing values post baseline were imputed using last observation carried forward (LOCF) where at least one post baseline measurement was available at a visit before the missing observation.||ml||Standard Deviation|Mean
824957|NCT01184859|Secondary|Change From Baseline in Nocturnal Urine Volume at Approximately Day 32|Nocturnal urine volume was recorded over three consecutive days per week in diaries kept by study participants. The average nocturnal urine volume of the 3 days recorded in the last week of the study (between study days 25-32) was compared to the average baseline readings.|3 days between study days -6 to 0 (Baseline), and days 25 to 32|Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance. Missing values post baseline were imputed using last observation carried forward (LOCF) where at least one post baseline measurement was available at a visit before the missing observation.||ml||Standard Deviation|Mean
824969|NCT01184872|Secondary|Duration of Treatment (Intravenous)|Duration of treatment is the interval from first to last intravenous (i.v.) administration. It was preferable that a patient complete the whole antibiotic treatment with the randomized i.v. study drug only. Duration of treatment in patients with bacteremia could be extended up to 28 days.|Up to 28 days|The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned at randomization.||Days||Standard Deviation|Mean
824958|NCT01184859|Secondary|Change From Baseline in Number of 24-hour Urine Voids at Approximately Day 32|Number of voids in 24 hours was recorded over three consecutive days per week in diaries kept by study participants. The average number of 24-hour voids of the 3 days recorded in the last week of the study (between study days 25-32) was compared to the average baseline readings.|3 days between study days -6 to 0 (Baseline), and days 25 to 32|Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance. Missing values post baseline were imputed using last observation carried forward (LOCF) where at least one post baseline measurement was available at a visit before the missing observation.||voids||Standard Deviation|Mean
824959|NCT01184859|Secondary|Change From Baseline in Number of Daytime Voids at Approximately Day 32|Number of daytime voids was recorded over three consecutive days per week in diaries kept by study participants. The average number of daytime voids of the 3 days recorded in the last week of the study (between study days 25-32) was compared to the average baseline readings.|3 days between study days -6 to 0 (Baseline), and days 25 to 32|Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance. Missing values post baseline were imputed using last observation carried forward (LOCF) where at least one post baseline measurement was available at a visit before the missing observation.||voids||Standard Deviation|Mean
824960|NCT01184859|Secondary|Change From Baseline in Total Sleep Time at Approximately Day 32|"Total sleep time is defined as the time spent asleep from initial sleep to final awakening.
Records of nocturia and sleep over three consecutive days per week were kept in voiding-sleep diaries by study participants. The average of the total time asleep of the 3 days recorded in the last week of the study (between study days 25-32) was compared to average baseline readings."|3 days between study days -6 to 0 (Baseline), and days 25 to 32|Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance. Missing values post baseline were imputed using last observation carried forward (LOCF) where at least one post baseline measurement was available at a visit before the missing observation.||minutes||Standard Deviation|Mean
824961|NCT01184859|Secondary|Change From Baseline in Duration of First Period of Undisturbed Sleep After 28 Days of Treatment - Period 2|"Duration of first period of undisturbed sleep is defined as the length of time from initial sleep to first awakening.
Records of nocturia and sleep over three consecutive days per week were kept in voiding-sleep diaries by study participants. The average length of first period of undisturbed sleep of the 3 days recorded in the last week of the study (between study days 25-32) was compared to average baseline readings."|3 days between study days -6 to 0 (Baseline), and days 25 to 32|Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance. Missing values post baseline were imputed using last observation carried forward (LOCF) where at least one post baseline measurement was available at a visit before the missing observation.||minutes||Standard Deviation|Mean
824962|NCT01184859|Secondary|Time When Urine Production <0.12 ml/kg/Min|Urine volume was registered and samples for osmolality check were collected every 30 minutes as long as there was an antidiuretic action defined as a urine production <0.12 mL/kg/min. The hydration due to water-loading should have lasted until end of action, defined as when the urine production returned to >0.12 mL/kg/min, but no longer than 12 hours.|Day 1|Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance.||hours||Standard Deviation|Mean
824963|NCT01184859|Secondary|Area Under the Urine Production Curve (AUCurine Prod)|Area under the urine production curve, from dose administration to end of action (AUCurine prod)|Day 1|Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance.||h*mL||Standard Deviation|Mean
824964|NCT01184859|Secondary|Area Under the Urine Osmolality Curve (AUCosm)|Area under the urine osmolality curve, from dose administration to end of action (AUCosm).|Day 1|Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance.||h*mOsm/kg||Standard Deviation|Mean
824965|NCT01184859|Primary|Change From Baseline in Number of Nocturnal Voids After 28 Days of Treatment - Period 2|Records of nocturia and sleep over three consecutive days per week were kept in voiding-sleep diaries by study participants. The average number of nocturnal voids of the 3 days recorded in the last week of the study (between study days 25-32) was compared to average baseline readings.|3 days between study days -6 to 0 (Baseline), and days 25 to 32|Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance. Missing values post baseline were imputed using last observation carried forward (LOCF) where at least one post baseline measurement was available at a visit before the missing observation.||nocturnal voids||95% Confidence Interval|Least Squares Mean
824966|NCT01184859|Primary|Duration of Action Defined as the Time With Urine Osmolality Above 200 mOsm/kg - Period 1|Participants were water-loaded to suppress the endogenous release of vasopressin, thus all antidiuretic activity was generated by desmopressin only. Water-loading was initiated 2 hours before dosing on Day 1. Urine volume was registered and samples for osmolality check were collected every 30 minutes as long as there was an antidiuretic action defined as a urine production <0.12 mL/kg/min. The hydration should have lasted until end of action, defined as when the urine production returned to >0.12 mL/kg/min, but no longer than 12 hours.|Day 1|Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance.||hours||Standard Deviation|Mean
824967|NCT01184872|Secondary|Number of Patients With Adverse Events, Serious Adverse Events and Death||Continuously from baseline up to 28 days after end of antibiotic treatment.|The safety set included all patients who received at least one dose of study medication and who had at least one post-baseline safety assessment.||participants|||Number
824968|NCT01184872|Secondary|Duration of Treatment (Intravenous and Oral)|Duration of treatment is the interval from first to last intravenous (i.v.) or to last oral administration if patients switched to an oral antibiotic therapy. It was preferable that a patient complete the whole antibiotic treatment with the randomized i.v. study drug only. Duration of treatment in patients with bacteremia could be extended up to 28 days.|Up to 28 days|The Full Analysis set (FAS) comprised all patients to whom study treatment had been assigned at randomization.||Days||Standard Deviation|Mean
825295|NCT01181726|Primary|AUC0-t of Corrected Total Estrone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on Corrected Total Estrone AUC0-t.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
824970|NCT01184872|Secondary|Number of Participants With Microbiological Response at Test-of-Cure (TOC) Visit|Microbiological Success: All infecting Gram-positive pathogens isolated at baseline were eradicated or presumed to be eradicated at the Test-of-Cure (TOC) evaluation and a super infecting pathogen was not isolated either prior to or at the TOC evaluation. Microbiological Failure: Persistence or relapse / re-infection of one or more infecting Gram-positive pathogens or isolation of a super infecting pathogen prior to or at the TOC evaluation.|Baseline and 7 to 14 days after end of therapy|Population analyzed consisted of patients from the clinically evaluable population who had independent microbiological assessments.||participants|||Number
824971|NCT01184872|Primary|Number of Patients With Clinical Success at the Test-Of-Cure (TOC) Visit|Success: Clinically significant signs and symptoms associated with the skin infection present at the pre-treatment infection site resolved (cure), or improved without need of further antibacterial therapy. Failure: Persistence or progression of signs and symptoms or development of new clinical signs and symptoms at the infection site, or concomitant antibacterial therapy with activity against isolated organisms, or treatment duration longer than pre-specified, or switch back to intravenous therapy due to relapse, or requirement of a major surgical procedure as adjunct or follow-up therapy.|Baseline and 7 to 14 days after end of therapy|The clinically evaluable population was used for the efficacy analysis. It included all patients who met the criteria for complicated skin and soft tissue, had no substantive protocol deviation, had a sponsor clinical response assessment of “success” or “failure” at the assessment visit, and had a specified baseline primary site of infection.||participants|||Number
824972|NCT01184885|Secondary|Complete Response|"To describe response rates to hyper-CVAD and sirolimus in adults with ALL and other aggressive lymphoid malignancies.
Bone marrow (<5% blasts) with adequate bone marrow cellularity, no evidence of circulating blasts or extramedullary disease and normalization of peripheral blood counts except for platelets (neutrophil count =1,000/µL)."|Every 21 days or as count recovery allows (at least 14 days apart) up to 24 weeks|||participants|||Number
824973|NCT01184885|Secondary|Induction Mortality|Induction mortality. Hyper-CVAD/ Rapamycin will be considered acceptable if induction mortality does not exceed 31% in patients older than 60, or 15% in those younger than 60|18 months||||||
824974|NCT01184885|Primary|Number of Participants With Count Recovery That Allows for Starting a Phase II Study to Evaluate Response Rates and Survival|"This will be assessed by evaluating the tolerability of this regimen compared to historical controls who received Hyper-CVAD or Hyper-CVAD/ Rituximab regimens. The treatment will be designated feasible for an individual subject if in 80% of chemotherapy cycles the subject has count recovery that allows for starting the subsequent cycle by Day 28. Count recovery is defined as ANC (absolute neutrophil count) of > 0.5 x 10^9/L and platelet count > 50 x 10^9/L.
Hyper-CVAD/Rapamycin will be deemed acceptable if it is feasible to administer in 80% or more of subjects."|18 months|||participants|||Number
824975|NCT01184898|Secondary|Partial Response|"Partial response is defined as:
Requires that all of the criteria for complete remission be satisfied except that the bone marrow may contain ≥ 5% blasts but < 25% blasts.
A marrow with <5% blasts that contain Auer rods will also be considered a PR"|Within one week of peripheral count recovery but no later than day 42|||participants|||Number
824976|NCT01184898|Secondary|Complete Response in the Absence of Platelet Recovery|"Complete response in the absence of platelet recovery is defined as:
- Bone marrow (<5% blasts) with adequate bone marrow cellularity, no evidence of circulating blasts or extramedullary disease and normalization of peripheral blood counts except for platelets (neutrophil count =1,000/µL)"|Within one week of peripheral count recovery but no later than day 42|||participants|||Number
824977|NCT01184898|Secondary|Complete Response|"Complete response is defined as:
Peripheral Blood Counts -Neutrophil count >1 x 109/L.
Platelet count ≥ 100 x 109/L.
Reduced hemoglobin concentration or hematocrit has no bearing on remission status.
Leukemic blasts must not be present in the peripheral blood.
Cellularity of bone marrow biopsy must be > 20% with maturation of all cell lines with < 5% blasts and no Auer rods.
Extramedullary leukemia, such as CNS or soft tissue involvement, must not be present"|Within one week of peripheral count recovery but no later than day 42|||participants|||Number
824978|NCT01184898|Primary|Association Between the Magnitude of mTOR Target Inhibition Post-treatment in Leukemic Blasts and Clinical Response in Patients With High Risk AML Treated With Sirolimus MEC|"Percent change compared between response groups (responder vs nonresponder).
This outcome measure only includes patients who survived to outcome assessment."|From pre- to post-treatment|||percentage change in leukemic blasts||Full Range|Mean
824979|NCT01184989|Primary|Dabigatran Concentration in Plasma, Measured With HPLC-MS/MS|Dabigatran Concentration in Plasma, measured with HPLC-MS/MS - Most relevant timepoints are reported here, ie timepoints of day 6|At day 6 before drug intake (di), at 1h, 2h, 4h, 8h and 24h after di|Correct calculation set: all patients of the Per Protocol set (PPS) (patients with at least one pair of observations for both PD and PK parameters without important protocol violations) and additionally all patients of the TS whom the only reason for not being in the PPS was the non-influential forbidden concomitant medication or vomiting||ng/mL||Geometric Coefficient of Variation|Geometric Mean
824980|NCT01184989|Primary|Dabigatran Concentration in Plasma, Estimated From Central Hemoclot®|"The Hemoclot® test kit measures the dTT (diluted Thrombin time). In the present trial, as a first step, the dTT in calibration samples that had known Dabigatran concentrations was measured centrally with the Hemoclot® test kit, and a linear calibration curve was fitted to the data from the calibration samples. Thereafter, for each patient at each time-point, the dTT was measured with the Hemoclot® kit and the Dabigatran concentration was read off from the calibration curve.
These estimated concentrations are compared with concentrations measured in parallel with HPLC-MS/MS.
As the trial objective is the method comparison and not the detection of the absolute concentrations of either of the methods, the result is reported as a relative bioavailability [%], see Statistical Analysis 1 below. Only concentrations >= LLOQ (Lower Limit of concentration) are included in the quantitative comparison."|Screening, day of surgery 1 hour (h) and 2h after drug intake (di) for late finalization of surgery, 4h and 8h after di for early finalization of surgery, 15 minutes (min) before di at days 2, 3, 4, 5 and 6, at day 6 also 1h, 2h, 4h, 8h and 24 after di|Correct calculation set: all patients of the Per Protocol set (PPS) (patients with at least one pair of observations for both PD and PK parameters without important protocol violations) and additionally all patients of the TS whom the only reason for not being in the PPS was the non-influential forbidden concomitant medication or vomiting||measurements estimated as above LLOQ|Participants||Number
824981|NCT01184989|Primary|Dabigatran Concentration in Plasma, Estimated From Local Hemoclot®|"The Hemoclot® test kit measures the dTT (diluted Thrombin time). In the present trial, as a first step, the dTT in calibration samples that had known Dabigatran concentrations was measured locally with the Hemoclot® test kit, and a linear calibration curve was fitted to the data from the calibration samples. Thereafter, for each patient at each time-point, the dTT was measured with the Hemoclot® kit and the Dabigatran concentration was read off from the calibration curve.
These estimated concentrations are compared with concentrations measured in parallel with HPLC-MS/MS.
As the trial objective is the method comparison and not the detection of the absolute concentrations of either of the methods, the result is reported as a relative bioavailability [%], see Statistical Analysis 1 below. Only concentrations >= LLOQ (Lower Limit of concentration) are included in the quantitative comparison."|Screening, day of surgery 1 hour (h) and 2h after drug intake (di) for late finalization of surgery, 4h and 8h after di for early finalization of surgery, 15 minutes (min) before di at days 2, 3, 4, 5 and 6, at day 6 also 1h, 2h, 4h, 8h and 24 after di|Correct calculation set: all patients of the Per Protocol set (PPS) (patients with at least one pair of observations for both PD and PK parameters without important protocol violations) and additionally all patients of the TS whom the only reason for not being in the PPS was the non-influential forbidden concomitant medication or vomiting||measurements estimated as above LLOQ|Participants||Number
824982|NCT01185834|Secondary|Overall Lens Fit|As assessed by the investigator at study visit using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit was graded by eye on a 5-point scale, with 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight|3 months of wear, replacing lenses monthly|Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses.||units on a scale|Participants|Standard Deviation|Mean
824983|NCT01185834|Primary|Overall Comfort|As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.|3 months of wear, replacing lenses monthly|Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses.||units on a scale||Standard Deviation|Mean
824984|NCT01185964|Secondary|Percentage of Participants With Anti-Olaratumab Antibody Assessment|Participants with Treatment Emergent (TE) anti-olaratumab antibodies were participants with a 4-fold increase (2 dilutions) increase over a positive baseline antibody titer or for a negative baseline titer, a participant with an increase from the baseline to a level of 1:20.|Baseline, Up to 30 Months|All participants who had baseline and post baseline anti-olaratumab antibodies.||percentage of participants|||Number
824985|NCT01185964|Secondary|PK: Half-Life (T1/2) Cycle 1 Day 8, Cycle 3 Day 8 of Olaratumab||Cycle 1 Day 8:Preinfusion,1hr,72hr,168hr Post Infusion; Cycle 3 Day 8: Preinfusion,1hr,24hr,72hr,168hr Post Infusion|All participants who had evaluable PK data in Phase 1b and Phase 2. Per protocol, optional Olaratumab monotherapy data was exploratory and not collected for this outcome measure.||Days||Full Range|Geometric Mean
824986|NCT01185964|Secondary|PK: Area Under Concentration Curve Versus Time (AUCτ) Cycle 1 Day 8, Cycle 3 Day 8 of Olaratumab|AUCτ = area under the concentration versus time curve during one dosing interval with a measurable concentration.|Cycle 1 Day 8:Preinfusion,1hr,72hr,168hr Post Infusion; Cycle 3 Day 8: Preinfusion,1hr,24hr,72hr,168hr Post Infusion|All participants who had evaluable PK data in Phase1b and Phase 2. Per protocol, optional Olaratumab monotherapy data was exploratory and not collected for this outcome measure.||microgram•hour/milliliter (μg•h/mL)||Geometric Coefficient of Variation|Geometric Mean
824987|NCT01185964|Secondary|PK: Minimum Concentration (Cmin) Cycle 1 Day 8, Cycle 3 Day 8 of Olaratumab||Cycle 1 Day 8: Preinfusion, 1hr,72hr,168hr Post Infusion; Cycle 3 Day 8: Preinfusion,1hr, 24hr,72hr,168hr Post Infusion|All participants who had evaluable PK data in Phase 1b and Phase 2. Per protocol, optional Olaratumab monotherapy data was exploratory and not collected for this outcome measure.||μg/mL||Geometric Coefficient of Variation|Geometric Mean
824988|NCT01185964|Secondary|Pharmacokinetic (PK) Maximum Concentration (Cmax) Cycle 1 Day 1, Cycle 3 Day 1 of Olaratumab||Cycle 1 Day 1: Preinfusion, End of Infusion,1hr,48hr,72hr,168 hr Post infusion; Cycle 3 Day 1:Preinfusion, End of Infusion,1hr,24hr,48hr,72hr,168hr Post Infusion|All participants who had evaluable PK data in Phase 1b and Phase 2. Per protocol, optional Olaratumab monotherapy data was exploratory and not collected for this outcome measure.||nanogram/milliliter (μg/mL )||Geometric Coefficient of Variation|Geometric Mean
824989|NCT01185964|Secondary|Percentage of Participants Who Are Progression-Free (PFS) at 3 Months|(PFS) rate is defined as the percentage of participants that are alive and progression-free 3 months after randomization. PFS is measured from randomization until the first radiographic progressive disease as defined by RECIST (version 1.1) or death from any cause. Participants who died without PD were considered to have progressed on the day of death. Censoring applied: If no radiologic assessment at baseline or post baseline, participant was censored at the date of randomization or the day of their last tumor assessment if no PD and were lost to follow up; If death or PD occurred after 2 or more consecutive missing radiographic visits, censoring occurred at the date of the last radiographic visit. If participant started new treatment before PD, participant was censored at the date of last tumor assessment prior to new therapy. If treatment was discontinued for reasons other than PD and no further assessment, censoring occurred at last tumor assessment.|Randomization Until First Radiographic PD or Death from Any Cause (Up to 3 Months)|All randomized participants in Phase 2. Per protocol, phase 1b and optional Olaratumab monotherapy data was exploratory and not collected for this outcome measure. Censored Participants = Phase 2 Olaratumab + Doxorubicin = 11 and Doxorubicin = 19.||percentage of participants||95% Confidence Interval|Number
825003|NCT01186406|Secondary|Median Progression-free Survival|Progression-free survival was defined as the time in months from the date study treatment started until the date of progression or the date of death if death occurred before progression, or until the date of last follow-up if alive without progression. Kaplan-Meier methods were used to estimate progression-free survival.|21 months|Intent-to-treat||months||95% Confidence Interval|Median
825004|NCT01186406|Secondary|Median Overall Survival|Overall survival was defined as the time in months from the start of SRS to the date of death or last contact if alive. Kaplan-Meier methods were used to estimate overall survival.|21 months|Intent-to-treat||months||95% Confidence Interval|Median
824990|NCT01185964|Secondary|Percentage of Participants With Objective Response (Objective Response Rate)|Objective Response Rate (ORR) is confirmed best overall tumor response of CR or PR. According to RECIST v1.1, PR defined as a >30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD; CR was defined as the disappearance of all target and non-target lesions. Percentage of participants was calculated as: total number of participants with a best tumor response of PR or CR among participants counted in the denominator/total number of participants treated with any amount of study drug, who has a complete radiographic assessment at baseline, and who has at least 1 complete radiographic assessment at postbaseline x 100%.|Randomization Until Progressive Disease (Up to 30 Months)|All randomized participants in Phase 2 and optional Olaratumab monotherapy.||percentage of participants||95% Confidence Interval|Number
824991|NCT01185964|Secondary|Overall Survival (OS)|OS was defined as the date of randomization to the date of death from any cause. Reasons for censoring OS were that participant was known to be alive, participant was lost to follow up during the study or participant withdrew consent to follow up.|Randomization to the Date of Death From Any Cause (Up To 47 Months)|All randomized participants in Phase 2. Per protocol, phase 1b and optional Olaratumab monotherapy data was exploratory and not collected for this outcome measure. Censored participants = Phase 2 Olaratumab + Doxorubicin = 27 and Doxorubicin = 15.||Months||95% Confidence Interval|Median
824992|NCT01185964|Secondary|Number of Participants With AEs and SAEs for Phase 2 Portion|A summary of SAEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.|Baseline, Up to 30 Months|All randomized participants who received at least 1 dose of study drug in Phase 2 and optional Olaratumab monotherapy.||participants|||Number
824993|NCT01185964|Primary|Number of Participants With Treatment Related Adverse Events (TEAE), Adverse Events (AE) or Serious Adverse Events (SAE) for Safety for the Phase 1b Portion of the Study|All Phase 1b participants who experienced at least 1 TEAE in the Phase 1b portion of the study. Adverse Event with missing relationship to study is counted as related. A summary of SAEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.|Baseline Up to 30 Months|All participants in Phase 1b.||participants|||Number
824994|NCT01185964|Primary|Progression-free Survival (PFS)|PFS is measured from randomization until the first radiographic documentation of progression of disease (PD) as defined by Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1) or death from any cause. Participants who died without PD was considered to have progressed on the day of death. The following censoring rules applied: If no radiologic assessment at baseline or post baseline, participant was censored at the date of randomization. Participants were censored at the day of their last tumor assessment if no PD and were lost to follow up; If death or PD occurred after 2 or more consecutive missing radiographic visits, censoring occurred at the date of the last adequate radiographic visit. If participant started new treatment before PD, the participant was censored at the date of last tumor assessment prior to new therapy. If treatment was discontinued for reasons other than PD and no further assessment, censoring occurred at last tumor assessment.|Randomization Until the First Radiographic Documentation of Objective Progression (Up to 29 Months)|All randomized participants in Phase 2. Per protocol, phase 1b and optional Olaratumab monotherapy data was exploratory and not collected for this outcome measure. Censored Participants = Phase 2 Olaratumab + Doxorubicin = 11 and Doxorubicin = 19.||Month||95% Confidence Interval|Median
824995|NCT01186250|Secondary|Change From Baseline in High-sensitivity C-reactive Protein (HsCRP) at One Year|measure of low levels of C-reactive protein to identify low but persistent levels of inflammation|Baseline and 1 year|participant drop put||mg/L||Standard Deviation|Mean
824996|NCT01186250|Secondary|Change From Baseline in ADMA (Asymmetric Dimethylarginine) at One Year.|Competitive ELISA assay in Stanford laboratory.|Baseline and 1 year|One participant in one arm did not have Baseline or one year data.||umol/L||Standard Deviation|Mean
824997|NCT01186250|Secondary|Change in Maximal Intimal Thickness(MIT) by Intravascular Unltrasound(IVUS)|The change in maximal intimal thickness (MIT) from baseline to one year was recorded for several matched sites in the same coronary artery, the cross sections, predominantly in the left anterior descending coronary artery, from baseline to one-year follow-up, were studied. The IVUS cross sections were matched by using identifiable landmarks in the images, such as bifurcations or arterial calcification, or external landmarks, such as coronary veins or pericardium. In addition, the one-year IVUS studies were obtained with an angiographic roadmap of where the initial IVUS study was performed along the length of the vessel. The IVUS system auto pullback was performed at .5 mm/s from the mid-distal portion of the study vessel, where an easily identifiable landmark was visible (i.e., branchpoint). The following items were measured for each patient: maximal intimal thickness (MIT), intimal area (IA), and vessel area.|Baseline and 1 year|number participants analyzed contained drops out due to clinical reasons||mm||Standard Deviation|Mean
824998|NCT01186250|Secondary|Change From Baseline in TG/HDL Ratio at One Year|Triglyceride ratio to High Density Lipoprotien|Baseline and 1 year|One drop out||ratio||Standard Deviation|Mean
824999|NCT01186250|Secondary|Change in Levels of Fasting Glucose at Baseline and 1 Year|Oral Glucose Tolerance Test : blood was drawn for fasting plasma glucose and insulin levels, followed by ingestion of a solution containing 75grams of glucose. Repeat blood samples were collected for glucose and insulin levels at 30, 90, and 120 minutes after glucose ingestion. All glucose measurements were performed by the Clinical Translational Research Unit (CTRU) Stanford University.|Baseline and 1 year|One participant in each group did not complete the OGTT.||mg/dL||Standard Deviation|Mean
825000|NCT01186250|Secondary|Change in Intimal Volume|Intimal volume is defined as external elastic membrane volume minus lumen (luminal) volume measured at the heart Catheterization and intravascular Ultrasound( IVUS)|baseline and 1 year|The number of participants enrolled were not all included in the intimal volume analysis because the Angiographic diagnostic evaluation needed for intimal volume measurement was clinically inappropriate for 3 in the pioglitazone arm and 5 in the Placebo arm at 12 months post transplant.||mm^3||Standard Deviation|Mean
825001|NCT01186250|Primary|Insulin Levels Area Under Curve(AUC)|Change from baseline in Insulin Levels During Oral Glucose Tolerance test at 1 year.|Baseline and 1 year|||h*pmol/L||95% Confidence Interval|Mean
825002|NCT01186406|Secondary|Unacceptable Toxicity Related to the Treatment Regimen|The number of patients experiencing unacceptable toxicity defined as the occurrence of ≥ grade 2 CNS hemorrhage or treatment-related grade 4 or 5 non-hematologic toxicity.|27 months|||participants|||Number
825005|NCT01186406|Primary|21-month Overall Survival|The percentage of participants alive at 21 months after the start of study treatment. Overall survival was calculated from the date study treatment started until the date of death or the date of last follow-up if alive. Kaplan-Meier methods were used to estimate overall survival.|21 months|Intent-to-treat||percentage of participants||95% Confidence Interval|Number
825006|NCT01186419|Secondary|Area Under The Steady-state Plasma Concentration-time Curve (AUC) of SPD602|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure of how much and how long a drug stays in a body.|92 weeks|PK Analysis Set, defined as all subjects in the Safety Set for whom the primary PK data were considered sufficient and interpretable. The Safety Set was defined as all subjects who received any amount of investigational product.||ng*hr/ml||Standard Deviation|Mean
825007|NCT01186419|Secondary|Maximum Plasma Concentration (Cmax) of SPD602|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administered.|92 weeks|Pharmacokinetic (PK) Analysis Set, defined as all subjects in the Safety Set for whom the primary PK data were considered sufficient and interpretable. The Safety Set was defined as all subjects who received any amount of investigational product.||ng/ml||Standard Deviation|Mean
825008|NCT01186419|Primary|Change From Baseline in Liver Iron Concentration (LIC) at 96 Weeks|LIC was determined by R2 Magnetic Resonance Imaging (MRI).|Baseline and 96 weeks|Full Analysis Set, defined as all subjects in the Safety Set who had at least 1 post-baseline primary efficacy assessment. The Safety Set was defined as all subjects who received any amount of investigational product.||mg/g||Standard Deviation|Mean
825009|NCT01186458|Secondary|Biologic Interaction|To explore the biologic interaction between fludarabine and Velcade and determine if Velcade can potentiate the DNA-damaging effect of fludarabine.|6 months|Data for this secondary objective was not collected or analyzed due to the termination of the study.|||||
825010|NCT01186458|Secondary|Toxicity|To evaluate the toxicity profile of this regimen. Adverse event counts by grade are presented.|6 months|||number of adverse events|||Number
825011|NCT01186458|Secondary|Survival|To evaluate the progression-free survival and event-free survival in patients who receive therapy with fludarabine, Velcade, and rituximab.|6 months|Data for this secondary objective was not collected or analyzed due to the termination of the study.|||||
825012|NCT01186458|Primary|Overall Response Rate|To determine the overall response rate and frequency of complete and partial responses in patients with relapsed or refractory follicular non-Hodgkin lymphoma (NHL) who receive therapy with fludarabine, Velcade, and rituximab administered every 28 days.|6 months|Data for this primary objective was not collected or analyzed due to the termination of the study.|||||
825013|NCT01186562|Secondary|Acute C-peptide Response (ACR) to Glucose|Derived from intravenous glucose tolerance test (0 to 10 minute measures after IV dextrose bolus)|18 months|This test required two IVs. In patients for whom 2 IVs could not be placed successfully, this test could not be performed. N's reflect number of patients completing this test.||min*ng/dL||Standard Error|Mean
825014|NCT01186562|Secondary|Acute C-peptide Response (ACR) to Glucose|Derived from intravenous gluocose tolerance testing (0 to 10 minute measures after dextrose bolus)|12 months|This test required two IVs. In patients for whom 2 IVs could not be placed successfully, this test could not be performed. N's reflect number of patients completing this test.||min*ng/dL||Standard Error|Mean
825015|NCT01186562|Secondary|AUC C-peptide|AUC C-peptide (ng/dL*min) from mixed meal tolerance test (measured times 0 to 2 hours after Boost HP)|18 months|Patients with vomiting, NPO (Nothing by Mouth) restrictions (due to chronic GI illness) were not able to complete MMTT. (Mixed meal Tolerance Test) The N for each group reflects the number of patients who successfully completed this assessment.||min*ng/dL||Standard Deviation|Mean
825016|NCT01186562|Secondary|Area Under the Curve (AUC) C-peptide (ng/dL*Min)|AUC C-peptide obtained from a mixed meal test (measured time 0 to 2 hours after Boost HP)|12 months|Patients with vomiting, NPO restrictions (due to chronic GI illness) were not able to complete MMTT. The N for each group reflects the number of patients who successfully completed this assessment.||ng*min/dL||Standard Error|Mean
825017|NCT01186562|Secondary|Insulin Independence|percentage of patients insulin independent|18 months|||percentage of participants|||Number
825018|NCT01186562|Primary|Insulin Independence|percentage of patients insulin independent|12 months|N's reflect patients that returned for study follow up.||percentage of participants|||Number
825296|NCT01181726|Primary|Cmax of Corrected Total Estrone(Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Corrected Total Estrone Cmax.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg/mL||Standard Deviation|Mean
825024|NCT01186705|Primary|Overall Objective Response Rate (ORR)|in patients with metastatic colorectal cancer with known PIK3CA mutations and wild type KRAS, to single agent MK-2206. Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1)|1 year|||participants|||Number
825025|NCT01186744|Secondary|Percentage of Participants With Pustular, Erythrodermic, or Guttate Psoriasis During CP-690,550 Re-Treatment (Period C)||Weeks 4, 8, and 16 (Period C)|Safety-C||percentage of participants|||Number
825026|NCT01186744|Secondary|Percentage of Participants With Pustular, Erythrodermic, or Guttate Psoriasis During Double-Blind Treatment Withdrawal (Period B)||Weeks 4, 8, 12, and 16 (Period B)|Safety-B||percentage of participants|||Number
825027|NCT01186744|Secondary|Percentage of Participants With Pustular, Erythrodermic, or Guttate Psoriasis During the Initial CP-690,550 Treatment (Period A)||Weeks 4, 8, 16, and 24 (Period A)|Safety-A||percentage of participants|||Number
825028|NCT01186744|Secondary|Mean Change From Baseline-C in EQ-5D Domain Scores During CP-690,550 Re-Treatment (Period C)|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. The score for each of the 5 dimensions can range from 1 to 3; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Baseline-C defined as the last observation up to first dosing date in Period C."|Week 56 (Period C)|FAS-C||scores on a scale||Standard Error|Mean
825029|NCT01186744|Secondary|Mean Change From Baseline-A in EQ-5D Domain Scores During the Initial CP-690,550 Treatment Period (Period A)|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. The score for each of the 5 dimensions can range from 1 to 3; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Baseline-A defined as the last observation up to first dosing date in Period A."|Week 24 (Period A)|FAS-A; n=number of participants with an observation||scores on a scale||Standard Error|Mean
825030|NCT01186744|Secondary|Mean EQ-5D Domain Scores During CP-690,550 Re-Treatment (Period C)|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. The score for each of the 5 dimensions can range from 1 to 3; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed)."|Baseline and Week 56 (Period C)|FAS-C; n equals the number of participants with an observation||score on a scale||Standard Error|Mean
825031|NCT01186744|Secondary|Mean EQ-5D Domain Scores During the Initial CP-690,550 Treatment Period (Period A)|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. The score for each of the 5 dimensions can range from 1 to 3; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed)."|Baseline and Week 24 (Period A)|FAS-A; n=number of participants with an observation.||score on a scale||Standard Error|Mean
825032|NCT01186744|Secondary|Mean Change From Baseline-C in EQ-5D Utility Score and VAS Scores During CP-690,550 Re-Treatment (Period C)|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. Baseline-C defined as the last observation up to first dosing date in Period C."|Week 56 (Period C)|FAS-C||scores on a scale||Standard Error|Mean
825033|NCT01186744|Secondary|Mean Change From Baseline-A in EQ-5D Utility Score and VAS Scores During the Initial CP-690,550 Treatment Period (Period A)|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. Baseline-A defined as the last observation up to first dosing date in Period A."|Week 24 (Period A)|FAS-A; n=number of participants with an observation||scores on a scale||Standard Error|Mean
825070|NCT01186744|Secondary|Mean DLQI Score During the Double-Blind Treatment Withdrawal (Period B)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.|Baseline and Weeks 4, 8, 12, and 16 (Period B)|FAS-B; n equals the number of participants with observations||score on a scale||Standard Error|Mean
825034|NCT01186744|Secondary|Mean EQ-5D Utility Score and VAS Scores During CP-690,550 Re-Treatment (Period C)|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state."|Baseline and Week 56 (Period C)|FAS-C; n equals the number of participants with an observation||score on a scale||Standard Error|Mean
825035|NCT01186744|Secondary|Mean EuroQol 5 Dimensions (EQ-5D) Health State Profile Utility Score and VAS Scores During the Initial CP-690,550 Treatment Period (Period A)|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state."|Weeks 4, 8, 16, and 24 (Period A)|FAS-A; n=number of participants with an observation.||score on a scale||Standard Error|Mean
825036|NCT01186744|Secondary|Percentage of Participants Maintaining PtGA Response of Clear or Almost Clear During the Double-Blind Treatment Withdrawal (Period B) Among Participants Who Had a Response of Clear or Almost Clear at Beginning of Period B|The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5 point scale. The scale is scored as follows: 0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe. Response defined as score of 0 or 1.|Weeks 4, 8, 12, and 16 (Period B)|FAS-B||percentage of participants||95% Confidence Interval|Number
825037|NCT01186744|Secondary|Percentage of Participants With PtGA Response of Clear or Almost Clear During CP-690,550 Re-Treatment (Period C) Among Participants Who Had a PtGA of Mild, Moderate or Severe During CP-690,550 Treatment Withdrawal (Period B)|The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5 point scale. The scale is scored as follows: 0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe. Response defined as score of 0 or 1.|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C||percentage of participants||95% Confidence Interval|Number
825038|NCT01186744|Secondary|Percentage of Participants With PtGA Response of Clear or Almost Clear During the Initial CP-690,550 Treatment (Period A)|The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5 point scale. The scale is scored as follows: 0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe. Response defined as score of 0 or 1.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A||percentage of participants||95% Confidence Interval|Number
825039|NCT01186744|Secondary|Percentage of Participants in Each PtGA of Psoriasis Category During CP-690,550 Re-Treatment (Period C)|The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5 point scale. The scale is scored as follows: 0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe.|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C||percentage of participants|||Number
825040|NCT01186744|Secondary|Percentage of Participants in Each PtGA of Psoriasis Category During Double-Blind Treatment Withdrawal (Period B)|The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5 point scale. The scale is scored as follows: 0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe.|Baseline and Weeks 4, 8, 12, and 16 (Period B)|FAS-B; n equals the number of participants with observations||percentage of participants|||Number
825041|NCT01186744|Secondary|Percentage of Participants in Each Patient Global Assessment (PtGA) of Psoriasis Category During the Initial CP-690,550 Treatment (Period A)|The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5 point scale. The scale is scored as follows: 0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe|Baseline and Weeks 4, 8, 16 and 24 (Period A)|FAS-A||percentage of participants|||Number
825042|NCT01186744|Secondary|Mean Change From Baseline-C in SF-36 Domain Scores During CP-690,550 Re-Treatment (Period C)|The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Higher scores indicate a better health related quality of life. Baseline-C defined as the last observation up to first dosing date in Period C.|Week 56 (Period C)|FAS-C||scores on a scale||Standard Error|Mean
825043|NCT01186744|Secondary|Mean Change From Baseline-A in SF-36 Domain Scores During the Initial CP-690,550 Treatment (Period A)|The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Higher scores indicate a better health related quality of life. Baseline-A defined as the last observation up to first dosing date in Period A.|Week 24 (Period A)|FAS-A; n=number of participants with an observation||scores on a scale||Standard Error|Mean
825044|NCT01186744|Secondary|Mean SF-36 Domain Scores During CP-690,550 Re-Treatment (Period C)|The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Higher scores indicate a better health related quality of life.|Baseline and Week 56 (Period C)|FAS-C; n equals the number of participants with an observation||score on a scale||Standard Error|Mean
825045|NCT01186744|Secondary|Mean SF-36 Domain Scores During the Initial CP-690,550 Treatment (Period A)|The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Higher scores indicate a better health related quality of life.|Baseline and Week 24 (Period A)|FAS-A; n=number of participants with an observation||score on a scale||Standard Error|Mean
825046|NCT01186744|Secondary|Mean Change From Baseline-C in SF-36 PCS and MCS Scores During CP-690,550 Re-Treatment (Period C)|The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). A PCS score and MCS score are based on a normalized sum of the 8 scale scores; PCS/MCS summary concept score = (raw score*10) plus 50. Linear transformations were performed to transform scores to a mean of 50 and SDs of 10, in the general population. In norm-based scoring, each scale is scored to have same average (50)/SD (10). With this method anytime a scale score is below 50, health status is below average, and each point is one-tenth of a SD. Higher scores indicate a better health related quality of life.|Week 56 (Period C)|FAS-C||scores on a scale||Standard Error|Mean
825047|NCT01186744|Secondary|Mean Change From Baseline-A in SF-36 PCS and MCS Scores During the Initial CP-690,550 Treatment (Period A)|The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). A PCS score and MCS score are based on a normalized sum of the 8 scale scores; PCS/MCS summary concept score = (raw score*10) plus 50. Linear transformations were performed to transform scores to a mean of 50 and SDs of 10, in the general population. In norm-based scoring, each scale is scored to have same average (50)/SD (10). With this method anytime a scale score is below 50, health status is below average, and each point is one-tenth of a SD. Higher scores indicate a better health related quality of life.|Week 24 (Period A)|FAS-A||scores on a scale||Standard Error|Mean
825048|NCT01186744|Secondary|Mean SF-36 PCS and MCS Scores During CP-690,550 Re-Treatment (Period C)|The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). A PCS score and MCS score are based on a normalized sum of the 8 scale scores; PCS/MCS summary concept score = (raw score*10) plus 50. Linear transformations were performed to transform scores to a mean of 50 and SDs of 10, in the general population. In norm-based scoring, each scale is scored to have same average (50)/SD (10). With this method anytime a scale score is below 50, health status is below average, and each point is one-tenth of a SD. Higher scores indicate a better health related quality of life.|Baseline and Week 56 (Period C)|FAS-C; n equals the number of participants with an observation||score on a scale||Standard Error|Mean
825049|NCT01186744|Secondary|Mean Short-Form 36 (SF-36) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores During the Initial CP-690,550 Treatment (Period A)|The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). A PCS score and MCS score are based on a normalized sum of the 8 scale scores; PCS/MCS summary concept score = (raw score*10) plus 50. Linear transformations were performed to transform scores to a mean of 50 and standard deviations (SDs) of 10, in the general population. In norm-based scoring, each scale is scored to have same average (50)/SD (10). With this method anytime a scale score is below 50, health status is below average, and each point is one-tenth of a SD. Higher scores indicate a better health related quality of life.|Baseline and Week 24 (Period A)|FAS-A; n=number of participants with an observation||score on a scale||Standard Error|Mean
825050|NCT01186744|Secondary|Median Time to DLQI ≥5-Point Reduction From Baseline-A Response During CP-690,550 Re-Treatment (Period C)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.|Weeks 4, 8, and 16 (Period C)|FAS-C participants with Baseline-C DLQI ≥5, where Baseline-C defined as the last observation up to first dosing date in Period C.||weeks||95% Confidence Interval|Median
825051|NCT01186744|Secondary|Percentage of Participants With DLQI ≥5-Point Reduction From Baseline-A Response During CP-690,550 Re-Treatment (Period C)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.|Weeks 4, 8, and 16 (Period C)|FAS-C participants with Baseline-C DLQI ≥5, where Baseline-C defined as the last observation up to first dosing date in Period C.||percentage of participants||95% Confidence Interval|Number
825052|NCT01186744|Secondary|Median Time to DLQI ≥5-Point Reduction From Baseline-A Response During Initial CP-690,550 Treatment (Period A)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A participants with Baseline-A DLQI ≥5, where Baseline-A was defined as the last observation before the first dosing date in Period A.||weeks||95% Confidence Interval|Median
825053|NCT01186744|Secondary|Percentage of Participants With DLQI ≥5-Point Reduction From Baseline-A Response During Initial CP-690,550 Treatment (Period A)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A participants with Baseline-A DLQI ≥5, where Baseline-A was defined as the last observation before the first dosing date in Period A.||percentage of participants||95% Confidence Interval|Number
825054|NCT01186744|Secondary|Percentage of Participants by DLQI Severity Category During the Initial CP-690,550 Treatment (Period A)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). Severity is measured using the following categories of scores: 0-1=no effect on patients' lives; 2-5=small effect; 6-10=moderate effect; 11-20=very large effect; 21-30=extremely large effect.|Baseline and Weeks 4, 8, 16, and 24 (Period A)|FAS-A||percentage of participants|||Number
825055|NCT01186744|Secondary|Percentage of Participants Achieving DLQI ≤1 Response During CP-690,550 Re-Treatment (Period C)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C participants with a Baseline-C DLQI >1, where Baseline-C is defined as the last observation up to first dosing date in Period C.||percentage of participants||95% Confidence Interval|Number
825056|NCT01186744|Secondary|Percentage of Participants Achieving DLQI ≤1 Response During Double-Blind Treatment Withdrawal (Period B)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.|Weeks 4, 8, 12, and 16 (Period B)|FAS-B participants with Baseline-B DLQI >1 where Baseline-B defined as last observation up to first dosing date in Period B.||percentage of participants|||Number
825057|NCT01186744|Secondary|Percentage of Participants Achieving DLQI ≤1 Response During the Initial CP-690,550 Treatment (Period A)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A participants with a Baseline-A DLQI ≤1, where Baseline-A is defined as the last observation up to first dosing date in Period A.||percentage of participants||95% Confidence Interval|Number
825058|NCT01186744|Secondary|Percentage of Participants Achieving DLQI ≥5 Point Reduction From Baseline-C Response During CP-690,550 Re-Treatment (Period C)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline. Baseline-C defined as the last observation up to first dosing date in Period C.|Weeks 4, 8, and 16 (Period C)|FAS-C participants with Baseline-C DLQI ≥5||percentage of participants||95% Confidence Interval|Number
825059|NCT01186744|Secondary|Percentage of Participants Achieving DLQI ≥5 Point Reduction From Baseline-B Response During Double-Blind Treatment Withdrawal (Period B)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.|Weeks 4, 8, 12, and 16 (Period B)|FAS-B participants with Baseline-B DLQI ≥5.||percentage of participants|||Number
825060|NCT01186744|Secondary|Percentage of Participants Achieving DLQI ≥5 Point Reduction From Baseline-A Response During Initial CP-690,550 Treatment (Period A)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A participants with a Baseline-A DLQI ≥5, where Baseline-A is defined as the last observation up to first dosing date in Period A. n=participants with an observation.||percentage of participants||95% Confidence Interval|Number
825069|NCT01186744|Secondary|Mean Change From Baseline-A in DLQI Score During the Initial CP-690,550 Treatment (Period A)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline. Baseline-A defined as the last observation up to first dosing date in Period A.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A||scores on a scale||Standard Error|Mean
825061|NCT01186744|Secondary|Mean Change From Baseline-C in DLQI Subscale Scores During the CP-690,550 Re-Treatment (Period C)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much); higher scores indicate poor quality of life. The DLQI can be analyzed under 6 subscales by combining questions and is categorized as follows: symptoms and feelings (maximum score=6); daily activities (maximum score=6); leisure (maximum score=6); work and school (maximum score=3); personal relationships (maximum score=6); and treatment (maximum score=3). The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline. Baseline-C defined as the last observation up to first dosing date in Period C.|Weeks 4, 8, and 16 (Period C)|FAS-C; n equals the number of participants with an observation||scores on a scale||Standard Error|Mean
825062|NCT01186744|Secondary|Mean Change From Baseline-B in DLQI Subscale Scores During the Double-Blind Treatment Withdrawal (Period B)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much); higher scores indicate poor quality of life. The DLQI can be analyzed under 6 subscales by combining questions and is categorized as follows: symptoms and feelings (maximum score=6); daily activities (maximum score=6); leisure (maximum score=6); work and school (maximum score=3); personal relationships (maximum score=6); and treatment (maximum score=3). The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline. Baseline-B defined as the last observation up to first dosing date in Period B.|Weeks 4, 8, 12, and 16 (Period B)|FAS-B; n equals the number of participants with observations||scores on a scale||Standard Error|Mean
825063|NCT01186744|Secondary|Mean Change From Baseline-A in DLQI Subscale Scores During the Initial CP-690,550 Treatment (Period A)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much); higher scores indicate poor quality of life. The DLQI can be analyzed under 6 subscales by combining questions and is categorized as follows: symptoms and feelings (maximum score=6); daily activities (maximum score=6); leisure (maximum score=6); work and school (maximum score=3); personal relationships (maximum score=6); and treatment (maximum score=3). The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline. Baseline-A defined as the last observation up to first dosing date in Period A.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A||scores on a scale||Standard Error|Mean
825064|NCT01186744|Secondary|Mean DLQI Subscale Scores During the CP-690,550 Re-Treatment (Period C)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much); higher scores indicate poor quality of life. The DLQI can be analyzed under 6 subscales by combining questions and is categorized as follows: symptoms and feelings (maximum score=6); daily activities (maximum score=6); leisure (maximum score=6); work and school (maximum score=3); personal relationships (maximum score=6); and treatment (maximum score=3).|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C; n equals the number of participants with an observation||score on a scale||Standard Error|Mean
825065|NCT01186744|Secondary|Mean DLQI Subscale Scores During the Double-Blind Treatment Withdrawal (Period B)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much); higher scores indicate poor quality of life. The DLQI can be analyzed under 6 subscales by combining questions and is categorized as follows: symptoms and feelings (maximum score=6); daily activities (maximum score=6); leisure (maximum score=6); work and school (maximum score=3); personal relationships (maximum score=6); and treatment (maximum score=3).|Baseline and Weeks 4, 8, 12, and 16 (Period B)|FAS-B; n equals the number of participants with observations||score on a scale||Standard Error|Mean
825066|NCT01186744|Secondary|Mean DLQI Subscale Scores During the Initial CP-690,550 Treatment (Period A)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much); higher scores indicate poor quality of life. The DLQI can be analyzed under 6 subscales by combining questions and is categorized as follows: symptoms and feelings (maximum score=6); daily activities (maximum score=6); leisure (maximum score=6); work and school (maximum score=3); personal relationships (maximum score=6); and treatment (maximum score=3).|Baseline and Weeks 4, 8, 16, and 24 (Period A)|FAS-A||score on a scale||Standard Error|Mean
825067|NCT01186744|Secondary|Mean Change From Baseline-C in DLQI Score During the CP-690,550 Re-Treatment (Period C)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline. Baseline-C defined as the last observation up to first dosing date in Period C.|Weeks 4, 8, and 16 (Period C)|FAS-C; n equals number of participants with an observation||scores on a scale||Standard Error|Mean
825068|NCT01186744|Secondary|Mean Change From Baseline-B in DLQI Score During the Double-Blind Treatment Withdrawal (Period B)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline. Baseline-B defined as the last observation up to first dosing date in Period B.|Weeks 4, 8, 12, and 16 (Period B)|FAS-B; n equals the number of participants with observations||scores on a scale||Standard Error|Mean
825071|NCT01186744|Secondary|Mean DLQI Score During the CP-690,550 Re-Treatment (Period C)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C; n equals the number of participants with an observation||score on a scale||Standard Error|Mean
825072|NCT01186744|Secondary|Mean Dermatology Life Quality Index (DLQI) Score During the Initial CP-690,550 Treatment (Period A)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.|Baseline and Weeks 4, 8, 16, and 24 (Period A)|FAS-A||score on a scale||Standard Error|Mean
825073|NCT01186744|Secondary|Median Time to ISI Reduction (2-point Decrease in ISI Score) During the CP-690,550 Re-Treatment (Period C)|The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate “your worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “No itching” (0) and “Worst possible itching” (10) at the ends.|Weeks 4, 8, and 16 (Period C)|FAS-C participants with Baseline-C ISI >1, where Baseline-C defined as the last observation up to first dosing date in Period C.||weeks||95% Confidence Interval|Median
825074|NCT01186744|Secondary|ISI Reduction (2-point Decrease in ISI Score) During the CP-690,550 Re-Treatment (Period C) - Percentage of Participant With a Response|The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate “your worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “No itching” (0) and “Worst possible itching” (10) at the ends.|Weeks 4, 8, and 16 (Period C)|FAS-C participants with Baseline-C ISI ≥2, where Baseline-C defined as the last observation up to first dosing date in Period C.||percentage of participants||95% Confidence Interval|Number
825075|NCT01186744|Secondary|Median Time to ISI Reduction (2-point Decrease in ISI Score) During the Initial CP-690,550 Treatment (Period A)|The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate “your worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “No itching” (0) and “Worst possible itching” (10) at the ends.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A participants with Baseline-A ISI ≥2, where Baseline-A was defined as the last observation before the first dosing date in Period A.||weeks||95% Confidence Interval|Median
825076|NCT01186744|Secondary|ISI Reduction (2-point Decrease in ISI Score) During the Initial CP-690,550 Treatment (Period A) - Percentage of Participants With a Response|The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate “your worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “No itching” (0) and “Worst possible itching” (10) at the ends.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A participants with Baseline-A ISI ≥2, where Baseline-A was defined as the last observation before the first dosing date in Period A.||percentage of participants||95% Confidence Interval|Number
825077|NCT01186744|Secondary|Median Time to ISI Score of ≤1 During the CP-690,550 Re-Treatment (Period C)|The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate “your worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “No itching” (0) and “Worst possible itching” (10) at the ends.|Weeks 4, 8, and 16 (Period C)|FAS-C participants with Baseline-C ISI >1, where Baseline-C defined as the last observation up to first dosing date in Period C.||weeks||95% Confidence Interval|Median
825078|NCT01186744|Secondary|ISI Score of ≤1 During CP-690,550 Re-Treatment (Period C) - Percentage of Participants With a Response|The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate “your worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “No itching” (0) and “Worst possible itching” (10) at the ends.|Weeks 4, 8, and 16 (Period C)|FAS-C participants with a Baseline-C ISI >1, where Baseline-C is defined as the last observation up to first dosing date in Period C.||percentage of participants||95% Confidence Interval|Number
825079|NCT01186744|Secondary|Median Time to ISI Score of ≤1 During the Initial CP-690,550 Treatment (Period A)|The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate “your worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “No itching” (0) and “Worst possible itching” (10) at the ends.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A participants with Baseline-A ISI >1, where Baseline-A was defined as the last observation before the first dosing date in Period A.||weeks||95% Confidence Interval|Median
825080|NCT01186744|Secondary|ISI Score of ≤1 During the Initial CP-690,550 Treatment (Period A) - Percentage of Participants With a Response|The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate “your worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “No itching” (0) and “Worst possible itching” (10) at the ends.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A participants with Baseline-A ISI >1, where Baseline-A was defined as the last observation before the first dosing date in Period A.||percentage of participants||95% Confidence Interval|Number
825081|NCT01186744|Secondary|Percentage of Participants Achieving ISI ≥2-Point Reduction During the CP-690,550 Re-Treatment (Period C)|The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate “your worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “No itching” (0) and “Worst possible itching” (10) at the ends.|Weeks 4, 8, and 16 (Period C)|FAS-C participants with a Baseline-C ISI ≥2, where Baseline-C is defined as the last observation up to first dosing date in Period C.||percentage of participants||95% Confidence Interval|Number
825082|NCT01186744|Secondary|Percentage of Participants Achieving ISI ≥2-Point Reduction During the Initial CP-690,550 Treatment (Period A)|The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate “your worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “No itching” (0) and “Worst possible itching” (10) at the ends.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A participants with a Baseline-A ISI ≥2, where Baseline-A is defined as the last observation up to first dosing date in Period A.||percentage of participants||95% Confidence Interval|Number
825083|NCT01186744|Secondary|Percentage of Participants Achieving an ISI Score of ≤1 During CP-690,550 Re-Treatment (Period C)|The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate “your worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “No itching” (0) and “Worst possible itching” (10) at the ends.|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C participants with a Baseline-C ISI >1, where Baseline-C is defined as the last observation up to first dosing date in Period C.||percentage of participants||95% Confidence Interval|Number
825084|NCT01186744|Secondary|Percentage of Participants Achieving ISI Score of ≤1 During the Initial CP-690,550 Treatment (Period A)|The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate “your worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “No itching” (0) and “Worst possible itching” (10) at the ends.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A participants with a Baseline-A ISI >1, where Baseline-A is defined as the last observation up to first dosing date in Period A.||percentage of participants||95% Confidence Interval|Number
825085|NCT01186744|Secondary|Percentage of Participants With ISI Score of 0 During CP-690,550 Re-Treatment (Period C)|The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate “your worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “No itching” (0) and “Worst possible itching” (10) at the ends.|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C participants with a Baseline-C ISI greater than (>) 0, where Baseline-C is defined as the last observation up to first dosing date in Period C.||percentage of participants||95% Confidence Interval|Number
825086|NCT01186744|Secondary|Percentage of Participants With ISI Score of 0 During the Initial CP-690,550 Treatment (Period A)|The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate “your worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “No itching” (0) and “Worst possible itching” (10) at the ends.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A participants with a Baseline-A ISI greater than (>) 0, where Baseline-A is defined as the last observation up to first dosing date in Period A.||percentage of participants||95% Confidence Interval|Number
825087|NCT01186744|Secondary|Mean Change From Baseline-C in ISI Score During the CP-690,550 Re-Treatment (Period C)|The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate “your worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “No itching” (0) and “Worst possible itching” (10) at the ends. Baseline-C defined as the last observation up to first dosing date in Period C.|Weeks 4, 8, and 16 (Period C)|FAS-C; n equals number of participants with an observation||score on a scale||Standard Error|Mean
825088|NCT01186744|Secondary|Mean Change From Baseline-B in ISI Score During the Double-Blind Treatment Withdrawal (Period B)|The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate “your worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “No itching” (0) and “Worst possible itching” (10) at the ends. Baseline-B defined as the last observation up to first dosing date in Period B.|Weeks 4, 8, 12, and 16 (Period B)|FAS-B; n equals the number of participants with observations||score on a scale||Standard Error|Mean
825089|NCT01186744|Secondary|Mean Change From Baseline-A in ISI Score During the Initial CP-690,550 Treatment (Period A)|The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate “your worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “No itching” (0) and “Worst possible itching” (10) at the ends. Baseline-A defined as the last observation up to first dosing date in Period A.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A||score on a scale||Standard Error|Mean
825090|NCT01186744|Secondary|Mean ISI Score During the CP-690,550 Re-Treatment (Period C)|The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate “your worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “No itching” (0) and “Worst possible itching” (10) at the ends.|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C; n equals the number of participants with an observation||score on a scale||Standard Error|Mean
825091|NCT01186744|Secondary|Mean ISI Score During the Double-Blind Treatment Withdrawal (Period B)|The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate “your worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “No itching” (0) and “Worst possible itching” (10) at the ends.|Baseline and Weeks 4, 8, 12, and 16 (Period B)|FAS-B; n equals the number of participants with observations||score on a scale||Standard Error|Mean
825092|NCT01186744|Secondary|Mean Itch Severity Item (ISI) Score During the Initial CP-690,550 Treatment (Period A)|The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate “your worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “No itching” (0) and “Worst possible itching” (10) at the ends.|Baseline and Weeks 4, 8, 16, and 24 (Period A)|FAS-A||score on a scale||Standard Error|Mean
825132|NCT01186744|Secondary|Median Time to PGA Response of Clear or Almost Clear During CP-690,550 Re-Treatment (Period C) Among Participants Who Had a PGA of Mild, Moderate, or Severe at the Beginning of Period C||Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C||weeks||95% Confidence Interval|Median
825093|NCT01186744|Secondary|Percentage of Participants With a PASI Score ≥125% of the Baseline-A PASI Score During the CP-690,550 Re-Treatment (Period C)|PASI quantifies severity of psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite score by investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head/neck, upper limbs, trunk, lower limbs), with adjustment for percent of BSA involved for each body region and for proportion of body region to the whole body. PASI score can vary in increments of 0.1 and range from 0.0-72.0; higher scores representing greater severity of psoriasis. Baseline-A defined as last observation up to first dosing date in Period A.|Weeks 4, 8, and 16 (Period C)|FAS-C; n equals the number of participants with an observation||percentage of participants||95% Confidence Interval|Number
825094|NCT01186744|Secondary|Percentage of Participants With a PASI Score ≥125% of the Baseline-A PASI Score During Double-Blind Treatment Withdrawal (Period B)|PASI quantifies severity of psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite score by investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head/neck, upper limbs, trunk, lower limbs), with adjustment for percent of BSA involved for each body region and for proportion of body region to the whole body. PASI score can vary in increments of 0.1 and range from 0.0-72.0; higher scores representing greater severity of psoriasis. Baseline-A defined as last observation up to first dosing date in Period A.|Weeks 4, 8, 12, and 16 (Period B)|FAS-B; n equals the number of participants with observations||percentage of participants|||Number
825095|NCT01186744|Secondary|Percentage of Participants With a PASI Score ≥125% of the Baseline-A PASI Score During Initial CP-690,550 Treatment (Period A)|PASI quantifies the severity of psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite score by the investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head and neck, upper limbs, trunk, and lower limbs), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0-72.0; higher scores representing greater severity of psoriasis.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A||percentage of participants||95% Confidence Interval|Number
825096|NCT01186744|Secondary|Percentage of Participants Achieving 100% Reduction in PASI Relative to Baseline-A (PASI100) During the CP-690,550 Re-Treatment (Period C)|PASI quantifies severity of psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite score by investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head/neck, upper limbs, trunk, lower limbs), with adjustment for percent of BSA involved for each body region and for proportion of body region to the whole body. PASI score can vary in increments of 0.1 and range from 0.0-72.0; higher scores representing greater severity of psoriasis. Baseline-A defined as last observation up to first dosing date in Period A.|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C; n equals the number of participants with an observation||percentage of participants||95% Confidence Interval|Number
825097|NCT01186744|Secondary|Percentage of Participants Achieving at Least a 90% Reduction in PASI Relative to Baseline-A (PASI90) During the CP-690,550 Re-Treatment (Period C)|PASI quantifies severity of psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite score by investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head/neck, upper limbs, trunk, lower limbs), with adjustment for percent of BSA involved for each body region and for proportion of body region to the whole body. PASI score can vary in increments of 0.1 and range from 0.0-72.0; higher scores representing greater severity of psoriasis. Baseline-A defined as last observation up to first dosing date in Period A.|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C; n equals the number of participants with an observation||percentage of participants||95% Confidence Interval|Number
825098|NCT01186744|Secondary|Percentage of Participants Achieving at Least a 50% Reduction in PASI Relative to Baseline-A (PASI50) During the CP-690,550 Re-Treatment (Period C)|PASI quantifies severity of psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite score by investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head/neck, upper limbs, trunk, lower limbs), with adjustment for percent of BSA involved for each body region and for proportion of body region to the whole body. PASI score can vary in increments of 0.1 and range from 0.0-72.0; higher scores representing greater severity of psoriasis. Baseline-A defined as last observation up to first dosing date in Period A.|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C; n equals the number of participants with an observation||percentage of participants||95% Confidence Interval|Number
825099|NCT01186744|Secondary|Percentage of Participants Achieving at Least a 100% Reduction in PASI Relative to Baseline-A (PASI100) During Period A|PASI quantifies the severity of psoriasis based on both lesion severity and the percent of BSA) affected. PASI is a composite score by the investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head and neck, upper limbs, trunk, and lower limbs), with adjustment for percent of BSA involved for each body region and for proportion of the body region to the whole body. PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A||percentage of participants||95% Confidence Interval|Number
825100|NCT01186744|Secondary|Percentage of Participants Achieving at Least a 90% Reduction in PASI Relative to Baseline-A (PASI90) During Period A|PASI quantifies the severity of psoriasis based on both lesion severity and the percent of BSA) affected. PASI is a composite score by the investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head and neck, upper limbs, trunk, and lower limbs), with adjustment for percent of BSA involved for each body region and for proportion of the body region to the whole body. PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A||percentage of participants||95% Confidence Interval|Number
825101|NCT01186744|Secondary|Percentage of Participants Achieving at Least a 50% Reduction in PASI Relative to Baseline-A (PASI50) During Period A|PASI quantifies the severity of psoriasis based on both lesion severity and the percent of BSA) affected. PASI is a composite score by the investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head and neck, upper limbs, trunk, and lower limbs), with adjustment for percent of BSA involved for each body region and for proportion of the body region to the whole body. PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A; NRI||percentage of participants||95% Confidence Interval|Number
825102|NCT01186744|Secondary|Mean Change From Baseline in PASI Component Scores During the CP-690,550 Re-Treatment (Period C)|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline defined as last observation up to first dosing date in Period C.|Weeks 4, 8, and 16 (Period C)|FAS-C; n equals number of participants with an observation||score on a scale||Standard Error|Mean
825103|NCT01186744|Secondary|Mean Change From Baseline in PASI Component Scores During Double-Blind Treatment Withdrawal (Period B)|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline defined as last observation up to first dosing date in Period B.|Weeks 4, 8, 12, and 16 (Period B)|FAS-B; n equals number of participants with an observation||score on a scale||Standard Error|Mean
825104|NCT01186744|Secondary|Mean Change From Baseline in PASI Component Scores During Initial CP-690,550 Treatment (Period A)|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline defined as last observation up to first dosing date in Period B.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A; n equals number of participants with an observation||score on a scale||Standard Error|Mean
825105|NCT01186744|Secondary|Mean PASI Component Scores During the CP-690,550 Re-Treatment (Period C)|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline defined as last observation up to first dosing date in Period C.|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C; n equals number of participants with an observation||score on a scale||Standard Error|Mean
825106|NCT01186744|Secondary|Mean PASI Component Scores During Double-Blind Treatment Withdrawal (Period B)|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline defined as last observation up to first dosing date in Period B.|Baseline and Weeks 4, 8, 12, and 16 (Period B)|FAS-B; n equals number of participants with an observation||score on a scale||Standard Error|Mean
825107|NCT01186744|Secondary|Mean PASI Component Scores During Initial CP-690,550 Treatment (Period A)|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline defined as last observation up to first dosing date in Period B.|Baseline and Weeks 4, 8, 16, and 24 (Period A)|FAS-A; n equals number of participants with an observation||score on a scale||Standard Error|Mean
825108|NCT01186744|Secondary|Mean Change From Baseline-C in PASI Score During the CP-690,550 Re-Treatment (Period C)|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline-C defined as last observation up to first dosing date in Period C.|Weeks 4, 8, and 16 (Period C)|FAS-C; n equals number of participants with an observation||scores on a scale||Standard Error|Mean
825133|NCT01186744|Secondary|Median Time to PASI75 Response During CP-690,550 Re-Treatment (Period C) For Those Who Had a >50% Reduction of Visit A4/Week 24 PASI Response During Double-Blind Treatment Withdrawal (Period B)|PASI75 response defined as at least a 75% reduction in PASI relative to baseline.|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C||weeks||95% Confidence Interval|Median
827202|NCT01202253|Secondary|Percentage of Participants With Oral Antifungal Started to Complete Therapy||Baseline up to Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria.||percentage of participants||95% Confidence Interval|Number
825109|NCT01186744|Secondary|Mean Change From Baseline-B in PASI Score During Double-Blind Treatment Withdrawal (Period B)|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline-B defined as last observation up to first dosing date in Period B.|Weeks 4, 8, 12, and 16 (Period B)|FAS-B; n equals the number of participants with observations||scores on a scale||Standard Error|Mean
825110|NCT01186744|Secondary|Mean Change From Baseline-A in PASI Score During Initial CP-690,550 Treatment (Period A)|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline-A defined as last observation up to first dosing date in Period A.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A||scores on a scale||Standard Error|Mean
825111|NCT01186744|Secondary|Mean PASI Score During the CP-690,550 Re-Treatment (Period C)|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline defined as last observation up to first dosing date in Period C.|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C; n equals the number of participants with an observation||score on a scale||Standard Error|Mean
825112|NCT01186744|Secondary|Mean PASI Score During Double-Blind Treatment Withdrawal (Period B)|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline defined as last observation up to first dosing date in Period B.|Baseline and Weeks 4, 8, 12, and 16 (Period B)|FAS-B; n equals the number of participants with observations||score on a scale||Standard Error|Mean
825113|NCT01186744|Secondary|Mean PASI Score During Initial CP-690,550 Treatment (Period A)|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis.|Baseline and Weeks 4, 8, 16, and 24 (Period A)|FAS-A||score on a scale||Standard Error|Mean
825114|NCT01186744|Secondary|Mean Change From Baseline in Percent of Psoriatic BSA by Body Region During CP-690,550 Re-Treatment (Period C)|Baseline defined as the last observation up to first dosing date in Period C.|Weeks 4, 8, and 16 (Period C)|FAS-C; n equals the number of participants with an observation||percent psoriatic BSA||Standard Error|Mean
825115|NCT01186744|Secondary|Mean Change From Baseline in Percent of Psoriatic BSA by Body Region During Double-Blind Treatment Withdrawal (Period B)|Baseline defined as the last observation up to first dosing date in Period B.|Weeks 4, 8, 12, and 16 (Period B)|FAS-B; n equals the number of participants with observations||percent psoriatic BSA||Standard Error|Mean
825116|NCT01186744|Secondary|Mean Change From Baseline in Percent of Psoriatic BSA by Body Region During Initial CP-690,550 Treatment (Period A)|Baseline defined as the last observation up to first dosing date in Period A.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A; n equals number of participants with an observation||percent change in psoriatic BSA||Standard Error|Mean
825117|NCT01186744|Secondary|Mean Percent of Psoriatic BSA by Body Region During CP-690,550 Re-Treatment (Period C)|Assessment of BSA with psoriasis performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The %surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis.|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C; n equals the number of participants with an observation||percent psoriatic BSA||Standard Error|Mean
825118|NCT01186744|Secondary|Mean Percent of Psoriatic BSA by Body Region During Double-Blind Treatment Withdrawal (Period B)|Assessment of BSA with psoriasis performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The %surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis.|Baseline and Weeks 4, 8, 12, and 16 (Period B)|FAS-B; n equals the number of participants with observations||percent psoriatic BSA||Standard Error|Mean
825119|NCT01186744|Secondary|Mean Percent of Psoriatic BSA by Body Region During Initial CP-690,550 Treatment (Period A)|Assessment of BSA with psoriasis performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The %surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis.|Baseline and Weeks 4, 8, 16, and 24 (Period A)|FAS-A; n equals number of participants with an observation||percent psoriatic BSA||Standard Error|Mean
825120|NCT01186744|Secondary|Mean Change From Baseline in Total Percent of Psoriatic BSA During CP-690,550 Re-Treatment (Period C)|Baseline was defined as the last observation until first dosing date in Period C.|Weeks 4, 8, and 16 (Period C)|FAS-C; n equals number of participants with an observation||percent change in psoriatic BSA||Standard Error|Mean
825121|NCT01186744|Secondary|Mean Change From Baseline in Total Percent of Psoriatic BSA During Double-Blind Treatment Withdrawal (Period B)|Baseline defined as the last observation up to first dosing date in Period B.|Weeks 4, 8, 12, and 16 (Period B)|FAS-B; n equals the number of participants with observations||percent change in psoriatic BSA||Standard Error|Mean
825122|NCT01186744|Secondary|Mean Change From Baseline in Total Percent of Psoriatic BSA During Initial CP-690,550 Treatment (Period A)|Baseline defined as the last observation up to first dosing date in Period A.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A; n equals number of participants with an observation||percent change in psoriatic BSA||Standard Error|Mean
825123|NCT01186744|Secondary|Mean Total Percent of Psoriatic BSA During CP-690,550 Re-Treatment (Period C)|Assessment of BSA with psoriasis performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The %surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis.|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C; n equals the number of participants with an observation||percent psoriatic BSA||Standard Error|Mean
825124|NCT01186744|Secondary|Mean Total Percent of Psoriatic BSA During Double-Blind Treatment Withdrawal (Period B)|Assessment of BSA with psoriasis performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The %surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis.|Baseline and Weeks 4, 8, 12, and 16 (Period B)|FAS-B; n equals the number of participants with observations||percent psoriatic BSA||Standard Error|Mean
825125|NCT01186744|Secondary|Mean Total Percent of Psoriatic Body Surface Area (BSA) During Initial CP-690,550 Treatment (Period A)|Assessment of BSA with psoriasis performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The %surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis.|Baseline and Weeks 4, 8, 16, and 24 (Period A)|FAS-A; n equals the number of participants with an observation.||percent psoriatic BSA||Standard Error|Mean
825126|NCT01186744|Secondary|Percentage of Participants With PGA Response of Clear or Almost Clear During the CP-690,550 Re-Treatment (Period C)|PGA response was defined as 0 (clear) or 1 (almost clear) on a 5-point scale where 0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe. 95% confidence interval is constructed using the normal approximation to the binomial distribution of one-sample proportion.|Weeks 4, 8, and 16 (Period C)|FAS-C||percentage of participants||95% Confidence Interval|Number
825127|NCT01186744|Secondary|Percentage of Participants With PGA Response of Clear or Almost Clear During Double-Blind Withdrawal Treatment (Period B)|PGA response was defined as 0 (clear) or 1 (almost clear) on a 5-point scale where 0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe. 95% confidence interval is constructed using the normal approximation to the binomial distribution of two-sample proportion.|Weeks 4, 8, 12, and 16 (Period B)|FAS-B||percentage of participants|||Number
825128|NCT01186744|Secondary|Percentage of Participants With PGA Response of Clear or Almost Clear During the Initial CP-690,550 Treatment (Period A)|PGA response was defined as 0 (clear) or 1 (almost clear) on a 5-point scale where 0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe. 95% confidence interval is constructed using the normal approximation to the binomial distribution of one-sample proportion.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A||percentage of participants||95% Confidence Interval|Number
825129|NCT01186744|Secondary|Percentage of Participants With a PASI75 Response During the CP-690,550 Re-Treatment (Period C)|PASI75 response defined as at least a 75% reduction in PASI relative to baseline. PASI responses in each period are relative to Baseline-A, where Baseline-A is defined as the last observation until first dosing date in Period A. 95% confidence interval is constructed using the normal approximation to the binomial distribution of one-sample proportion.|Weeks 4, 8, and 16 (Period C)|FAS-C||percentage of participants||95% Confidence Interval|Number
825130|NCT01186744|Secondary|Percentage of Participants With a PASI75 Response During Double-Blind Withdrawal Treatment (Period B)|PASI75 response defined as at least a 75% reduction in PASI relative to baseline. PASI responses in each period are relative to Baseline-A, where Baseline-A is defined as the last observation until first dosing date in Period A. 95% confidence interval is constructed using the normal approximation to the binomial distribution of one-sample proportion.|Weeks 4, 8, 12, and 16 (Period B)|FAS-B||percentage of participants|||Number
825131|NCT01186744|Secondary|Percentage of Participants With a PASI75 Response During the Initial CP-690,550 Treatment (Period A)|PASI75 response defined as at least a 75% reduction in PASI relative to baseline. Baseline defined as the last observation up to the first dosing date in Period A. 95% confidence interval is constructed using the normal approximation to the binomial distribution of one-sample proportion.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A||percentage of participants||95% Confidence Interval|Number
825134|NCT01186744|Secondary|Percentage of Participants Regaining PASI75 and PGA Response (PGA of Clear or Almost Clear) During CP-690,550 Re-Treatment (Period C) Who Had Lost Both PASI75 Response and PGA Response at the Beginning of Period C|PASI75 response defined as at least a 75% reduction in PASI relative to baseline. PASI responses at each period are relative to Baseline-A, where Baseline-A is defined as the last observation up to first dosing date in Period A. 95% confidence interval constructed using the normal approximation to the binomial distribution of one-sample proportion.|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C||percentage of participants||95% Confidence Interval|Number
825135|NCT01186744|Secondary|Median Time to Regain PASI75 and PGA Response (Clear or Almost Clear) During CP-690,550 Re-Treatment (Period C) Among Participants Who Lost Both PASI75 Response and PGA Response (Clear or Almost Clear) at the Beginning of Period C|PASI75 response defined as at least a 75% reduction in PASI relative to baseline.|Weeks 4, 8, and 16 (Period C)|FAS-C||weeks||95% Confidence Interval|Median
825136|NCT01186744|Secondary|Percentage of Participants Regaining PASI75 and PGA Response (Clear or Almost Clear) During CP-690,550 Re-Treatment (Period C) Among Participants Who Lost Both PASI75 Response and PGA Response (Clear or Almost Clear) at the Beginning of Period C|PASI75 response defined as at least a 75% reduction in PASI relative to baseline.|Weeks 4, 8, and 16 (Period C)|FAS-C||percentage of participants||95% Confidence Interval|Number
825137|NCT01186744|Secondary|Median Time to Loss of >50% of the Visit A4/Week 24 PASI Response and Loss of PGA Response (Clear or Almost Clear) During the Double-Blind Treatment Withdrawal (Period B)||Week 24 (Period A) and Weeks 4, 8, 12, and 16 (Period B)|FAS-B||weeks||95% Confidence Interval|Median
825138|NCT01186744|Secondary|Percentage of Participants Maintaining Adequate PASI Response and Maintaining PGA Response (Clear or Almost Clear) During the Double-Blind Treatment Withdrawal (Period B)|Adequate PASI response defined as less than or equal to 50% reduction of the Visit A4/Week 24 PASI Response.|Week 24 (Period A) and Weeks 4, 8, 12, and 16 (Period B)|FAS-B||percentage of participants||95% Confidence Interval|Number
825139|NCT01186744|Secondary|Percentage of Participants With PASI Score ≥125% of Baseline-A or New Type of Psoriasis (Pustular, Erythrodermic) During the Double-Blind Treatment Withdrawal (Period B)|The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI responses at each period are relative to Baseline-A where Baseline-A was defined as the last observation up to first dosing date in Period A. 95% confidence interval is constructed using the normal approximation to the binomial distribution of two-sample proportion.|Weeks 4, 8, 12, and 16 (Period B)|FAS-B; Overall number (n) indicates the total number of participants with PASI Score ≥125% of baseline at least once during Weeks 4 to 16 of Period B.||percentage of participants|||Number
825140|NCT01186744|Secondary|Percentage of Participants With PASI Score ≥125% of Baseline-A or New Type of Psoriasis (Pustular, Erythrodermic) During the Period Between Week 24 and Week 32 (Period B)|The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI responses at each period are relative to Baseline-A where Baseline-A was defined as the last observation up to first dosing date in Period A. Weeks 4 and 8 are relative to the Period B baseline and are the same as Weeks 28 and 32, which are relative to Period A baseline. 95% confidence interval is constructed using the normal approximation to the binomial distribution of two-sample proportion.|Weeks 4 and 8 (Period B)|FAS-B; Overall number (n) indicates the total number of participants with PASI Score ≥125% of baseline at least once during Weeks 4 to 8 of Period B.||percentage of participants||95% Confidence Interval|Number
825141|NCT01186744|Secondary|Median Time to Loss of Adequate Response During the Double-Blind Treatment Withdrawal (Period B)|Adequate response defined as >50% reduction of the Visit A4/Week 24 (last visit in Period A) PASI response.|Weeks 4, 8, 12, and 16 (Period B)|FAS-B||weeks||95% Confidence Interval|Median
825142|NCT01186744|Secondary|Percentage of Participant Maintaining an Adequate Response During the Double-Blind Treatment Withdrawal (Period B)|Adequate response defined as >50% reduction of the Visit A4/Week 24 (last visit in Period A) PASI response.|Weeks 4, 8, 12, and 16 (Period B)|FAS-B||percentage of participants||95% Confidence Interval|Number
825143|NCT01186744|Secondary|Percentage of Participants Achieving Both a PASI50-75 Response and Dermatology Life Quality Index (DLQI) ≤5 Response During Initial CP-690,550 Treatment (Period A)|PASI50-75 response defined as a reduction of at least 50% but less than 75%. The DLQI is a general dermatology questionnaire that consists of 10 items that assess participant health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A||percentage of participants||95% Confidence Interval|Number
825144|NCT01186744|Secondary|Median Time to PGA Response of Clear or Almost Clear During Initial CP-690,550 Treatment (Period A)|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response defined as 0 (clear) or 1 (almost clear).|Weeks 4, 8, 16, and 24 (Period A)|FAS-A||weeks||95% Confidence Interval|Median
825145|NCT01186744|Secondary|Median Time to PASI75 Response During Initial CP-690,550 Treatment (Period A)|The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. PASI75 response defined as 75% reduction in PASI relative to baseline.|Weeks 4, 8, 16, and 24 (Period A)|The Period A-Full Analysis Set (FAS-A) included all participants who were randomized at baseline and received at least 1 dose of the randomized investigational drug (CP-690,550 5mg BID or 10 mg BID) during Period A.||weeks||95% Confidence Interval|Median
825157|NCT01187004|Secondary|Intensive Care Unit (ICU) Length of Stay|If extracardiac complications, especially acute lung injury, prolonged Intensive Care Unit (ICU) length of stay due to longer mechanical ventilation.|at 28 days|The analysis of the Intensive Care Unit (ICU) length of stay was done on all the patients included in the study. We want to evaluate if the development of acute lung injury prolongs the intensive care unit length of stay.ICU length of stay was calculated up to 28 days,and patients who died before were considered as having the maximum value||days||Inter-Quartile Range|Median
825146|NCT01186744|Primary|Percentage of Participants Achieving a PGA Response of Clear or Almost Clear During CP-690,550 Re-treatment (Period C) Among Participants Who Had a PGA of Mild, Moderate, or Severe During Double-Blind Treatment Withdrawal (Period B)|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe).|Baseline and Weeks 4, 8, and 16 (Period C)|The Period C-Full Analysis Set (FAS-C) included all FAS-B participants who were advanced to the re-treatment period (Period C) during the 16 weeks of Period B and had received at least one dose of investigational drug (CP-690,550 5 mg BID or 10 mg BID) during Period C.||percentage of participants||95% Confidence Interval|Number
825147|NCT01186744|Primary|Percentage of Participants Achieving a PASI75 Response During CP-690,550 Re-Treatment (Period C) Among Those Who Had a Greater Than (>)50% Reduction of Visit A4/Week 24 PASI Response During Double-Blind Treatment Withdrawal (Period B)|The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. PASI75 response is defined as at least 75% reduction in PASI relative to Baseline/Day 1. Baseline defined as the last observation up to first dosing date in Period C. PASI responses at each period were relative to Baseline-A, where Baseline-A was defined as the last observation up to first dosing date in Period A.|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C||percentage of participants||95% Confidence Interval|Number
825148|NCT01186744|Primary|Percentage of Participants Maintaining a Physician's Global Assessment (PGA) Response During the Double-Blind Treatment Withdrawal (Period B)|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response defined as 0 (clear) or 1 (almost clear).|Weeks 4, 8, 12, and 16 (Period B)|FAS-B||percentage of participants||95% Confidence Interval|Number
825149|NCT01186744|Primary|Percentage of Participants Maintaining a Psoriasis Area and Severity Index 75 (PASI75) Response During the Double-Blind Treatment Withdrawal Period (Period B)|The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and the percent of body surface area (BSA) affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response defined as at least a 75 percent (%) reduction in PASI relative to baseline.|Weeks 4, 8 12, and 16 (Period B)|The Period B-Full Analysis Set (FAS-B) included all participants who were re-randomized at the end of Period A and received at least 1dose of investigational drug (CP-690,550 5 mg BID or 10 mg BID) or placebo at the beginning of Period B.||percentage of participants||95% Confidence Interval|Number
825150|NCT01186796|Secondary|Mean GH Half-Life in Response to Secretagogue|Subjects were administered 4 different secretagogues: (i) L-arginine/Saline, (ii) L-arginine/Ghrelin, (iii) L-arginine/GHRH, and (iv) L-arginine / GHRH + Ghrelin. The result was calculated on each 6-hr pool of data by utilizing a previously published deconvolution method and analyzed via two-way ANOVA.|Withdrawal of blood samples (2.5 mL each) every 10 min for 6 hr. Sampling will begin at 0800 h and conclude at 1400 h.|||min||Standard Error|Mean
825151|NCT01186796|Secondary|Mean Duration of GH Bursts (Mode) in Response to Secretagogue|Subjects were administered 4 different secretagogues: (i) L-arginine/Saline, (ii) L-arginine/Ghrelin, (iii) L-arginine/GHRH, and (iv) L-arginine / GHRH + Ghrelin. The result was calculated on each 6-hr pool of data by utilizing a previously published deconvolution method and analyzed via two-way ANOVA.|Withdrawal of blood samples (2.5 mL each) every 10 min for 6 hr. Sampling will begin at 0800 h and conclude at 1400 h.|||min||Standard Error|Mean
825152|NCT01186796|Secondary|Mean Mass of GH Released Per Burst in Response to Secretagogue|Subjects were administered 4 different secretagogues: (i) L-arginine/Saline, (ii) L-arginine/Ghrelin, (iii) L-arginine/GHRH, and (iv) L-arginine / GHRH + Ghrelin. The result was calculated on each 6-hr pool of data by utilizing a previously published deconvolution method and analyzed via two-way ANOVA.|Withdrawal of blood samples (2.5 mL each) every 10 min for 6 hr. Sampling will begin at 0800 h and conclude at 1400 h.|||ug/L||Standard Error|Mean
825153|NCT01186796|Secondary|Mean GH Concentration (Pulsatile) in Response to Secretagogue|Subjects were administered 4 different secretagogues: (i) L-arginine/Saline, (ii) L-arginine/Ghrelin, (iii) L-arginine/GHRH, and (iv) L-arginine / GHRH + Ghrelin. The result was calculated by averaging values over the 6 hour collection timeframe.|Withdrawal of blood samples (2.5 mL each) every 10 min for 6 hr. Sampling will begin at 0800 h and conclude at 1400 h.|||ug/L/6h||Standard Error|Mean
825154|NCT01186796|Primary|Mean Baseline GH Concentration|Averaged over 90-min baseline on the saline day.|Withdrawal of blood samples (2.5 mL each) every 10 min for 6 hr. Sampling will begin at 0800 h and conclude at 1400 h.|||ug/L||Standard Error|Mean
825155|NCT01186848|Primary|Live-rater by Two Blinded Dermatologists|"The primary outcome was a blinded rating of the treatment area (Fractional Laser vs. Fractional Laser plus Intense Focused Ultrasound) with the best cosmetic appearance. Two dermatologists blindly evaluated the treated and control areas of each side from live subjects on the final follow up visit (week 10). This was reported as percentages of participants for whom 1550-nm Erbium-doped Fractionated Laser or Micro-focused Ultrasound and 1550nm-fractionated Laser resulted in the best cosmetic appearance."|week 10|||Percentage of participants||95% Confidence Interval|Number
825156|NCT01186939|Primary|Number of Participants in Different Categories of Treatment Emergent Adverse Events for the Extension Period|Participant counts for a variety of subsets of treatment emergent adverse events (TEAEs)during the extension study period (43-68 months). Subsets include participants counts for serious TEAEs, serious TEAEs that the investigator evaluated as releated to treatment, TEAEs leading to discontinuation of therapy, or a dose reduction, or a dose interruption.|43- 68 months|Safety population includes all 40 participants in the extension study.||participants|||Number
825158|NCT01187004|Primary|Acute Lung Injury After Cardiac Surgery|to evaluate the incidence of acute lung injury (ALI) in patients undergoing cardiac surgery with cardiopulmonary by pass and to identify the main predictors.Diagnosis of Acute Lung Injury (ALI) was made according to the American-European Consensus conference criteria, including acute onset, PaO2 /FiO2 <300 regardless of Positive End Expiratory Pressure (PEEP) level, bilateral and diffuse opacities on chest radiograph, absence of left ventricular failure, or history of lung disease.|at seven days after intervention|Patients consecutively admitted to the cardiac Intensive Care Unit (cICU) after cardiac surgery on cardiopulmonary by pass (CPB), during a time frame of two years.The analysis was per protocol, to identify the predictors of acute lung injury after cardiac surgery.||participants|||Number
825159|NCT01187017|Secondary|Secondary Endpoints Will Evaluated for the Study to Include: (a) Hematologic Response at 3 and 12 Months and Yearly Thereafter; (b) Relapse (c) Clonal Evolution to Paroxysmal Nocturnal Hemoglobinuria (PNH), Myelodysplasia or Acute Leukemia; (e) Survival.||12 months||||||
825160|NCT01187017|Primary|Response Rate at 6 Months|The primary objective is to assess the Flu/Cy hematological response in SAA.The primary endpoint will be response at six months.|6 months|||participants|||Number
825161|NCT01187043|Primary|Induction Amenorrhea|Induction of amenorrhea as determined by suppression of ovulation and/or menses, measured by using ovulation timing kits and daily diary for bleeding. Five doses will be compared in an escalating-dose, to independent groups, to a run-in placebo treatment period.|10 weeks|Per protocol: subjects who exhibited trough levels of proellex on at least 7 of the 10 weekly visits during the dosing period||participants|||Number
825162|NCT01187355|Secondary|Likert Statement: When I Use This Solution, I Forget I am Wearing my Lenses.|As interpreted and reported by the subject on a questionnaire as a single, retrospective evaluation of the last three days of wearing experience. A 5-point Likert scale was used, where 1=strongly disagree, 2=disagree; 3=neither disagree nor agree; 4=agree; 5=strongly agree.|Day 30|All enrolled and dispensed subjects with an on-regimen follow-up visit.||Units on a scale||Standard Deviation|Mean
825163|NCT01187355|Secondary|Likert Statement: When I Use This Solution, My Lenses Are Comfortable From Morning Until Evening.|As interpreted and reported by the subject on a questionnaire as a single, retrospective evaluation of the last three days of wearing experience. A 5-point Likert scale was used, where 1=strongly disagree, 2=disagree; 3=neither disagree nor agree; 4=agree; 5=strongly agree.|Day 30|All enrolled and dispensed subjects with an on-regimen follow-up visit.||Units on a scale||Standard Deviation|Mean
825164|NCT01187355|Primary|Likert Statement: When I Use This Solution, I Can Comfortably Wear my Lenses.|As interpreted and reported by the subject on a questionnaire as a single, retrospective evaluation of the last three days of wearing experience. A 5-point Likert scale was used, where 1=strongly disagree, 2=disagree; 3=neither disagree nor agree; 4=agree; 5=strongly agree.|Day 30|All enrolled and dispensed subjects with an on-regimen follow-up visit.||Units on a scale||Standard Deviation|Mean
825165|NCT01187433|Primary|Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo|Injection-site reactions: Pain, Erythema, and Swelling. Systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Grade 3 Injection-site reactions (9 to 11 years): Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥5 cm. Grade 3 Injection site reactions (≥12 years): Pain, Significant; prevents daily activity; Erythema and Swelling, >10 cm. Grade 3 Systemic reactions: Fever, ≥39˚C; Headache, Malaise, Myalgia, and Asthenia, Significant; prevents daily activity.|Day 0 up to Day 14 post each vaccination|Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set.||Percentage of participants|||Number
825166|NCT01187433|Primary|Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo|Geometric mean titers were assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus naïve subjects at baseline are defined as those subjects with <10 (1/dil) for all serotypes with parental dengue virus strains and for yellow fever titer.|Before and 28 days after each injection|Geometric mean titer ratios were assessed in the Full Analysis Set.||Titer ratio||95% Confidence Interval|Geometric Mean
825167|NCT01187433|Primary|Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo|Geometric mean titers were assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus immune subjects at baseline are defined as those subjects with ≥10 (1/dil) for at least 1 serotype with the parental dengue virus strain or for the yellow fever titer.|Before and 28 days after each injection|Geometric mean titers were assessed in the Full Analysis Set.||Titers (1/dilutions)||95% Confidence Interval|Geometric Mean
825168|NCT01187433|Primary|Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo|Geometric mean titers were assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).|Before and 28 days after each injection|Geometric mean titers were assessed in the Full Analysis Set.||Titers (1/dilutions)||95% Confidence Interval|Geometric Mean
825169|NCT01187433|Primary|Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo|Geometric mean titer ratios were assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).|Before and 28 days after each injection|Geometric mean titer ratios were assessed in the Full Analysis Set.||Titer ratio||95% Confidence Interval|Geometric Mean
825170|NCT01187433|Primary|Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo|Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus naïve subjects at baseline are defined as those subjects with <10 (1/dil) for all serotypes with parental dengue virus strains and for yellow fever titer.|Before and 28 days after each injection|Seropositivity was assessed in the Full Analysis Set.||Percentage of participants|||Number
825240|NCT01187550|Secondary|Change From Baseline in Fasting Insulin at Week 4||Baseline and Week 4|ITT population set included all the participants who received at least 1 dose of study medication. Here ‘N’ (Number of participants analyzed) signified those participants who were evaluable for this measure.||picomole/L (pmol/L)||Standard Deviation|Mean
825171|NCT01187433|Primary|Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo|Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus immune subjects at baseline are defined as those subjects with ≥10 (1/dil) for at least 1 serotype with the parental dengue virus strain or for the yellow fever titer.|Before and 28 days after each injection|Seropositivity was assessed in the Full Analysis Set.||Percentage of participants|||Number
825172|NCT01187433|Primary|Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo|Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).|Before and 28 days after each injection|Seropositivity was assessed in the Full Analysis Set.||Percentage of participants|||Number
825173|NCT01187433|Primary|Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo|Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus naïve subjects at baseline are defined as those subjects with <10 (1/dil) for all serotypes with parental dengue virus strains and for yellow fever titer.|Before and 28 Days after each injection|Seropositivity was assessed in the Full Analysis Set.||Percentage of participants|||Number
825174|NCT01187433|Primary|Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo|Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus immune subjects at baseline are defined as those subjects with ≥10 (1/dil) for at least 1 serotype with the parental dengue virus strain or for the yellow fever titer.|Before and 28 days after each injection|Seropositivity was assessed in the Full Analysis Set.||Percentage of participants|||Number
825175|NCT01187433|Primary|Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo|Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).|Before and 28 days after each injection|Seropositivity was assessed in the Full Analysis Set.||Percentage of participants|||Number
825176|NCT01187498|Secondary|Patient Desire for Alternate Treatment|"Patient response to Do you wish to receive another form of treatment? (yes)"|post-treatment (week 8)|Completers minus one missing value||participants|||Number
825177|NCT01187498|Secondary|Patient Global Rating of Bothersomeness of Side Effects|"Patient global rating of how bothersome their side effects were (no side effects to extremely bothersome)"|post-treatment (week 8)|Completers minus one missing value||participants|||Number
825178|NCT01187498|Secondary|Patient Report of Symptom Distress|"Patient report of how disturbed they were by symptoms (not at all to extremely)"|post-treatment (week 8)|Completers minos one missing value||participants|||Number
825179|NCT01187498|Secondary|Patient Global Rating of Activity Restriction|"Patient global rating of activity restriction (not at all to all the time)"|post-treatment (week 8)|Com0leters minus one missing value||participants|||Number
825180|NCT01187498|Secondary|Patient Satisfaction|"Patient global rating of satisfaction with progress in treatment (completely satisfied to very dissatisfied)"|post-treatment (week 8)|Completers minus one missing value||participants|||Number
825181|NCT01187498|Secondary|Patient Global Perception of Improvement (GPI)|"Patient global perception of improvement (much better to much worse)"|post-treatment (week 8)|Completers minus one missing value||participants|||Number
825182|NCT01187498|Secondary|Change on American Urological Association (AUA) Symptom Index|Change in score on American Urological Association (AUA) Symptom Index (baseline to week 8). The index measures lower urinary tract symptoms. Scores range from 0 to 35, with higher scores indicating worse symptoms.|baseline to post-treatment (week 8)|Completers||Scores on the scale||Standard Deviation|Mean
825183|NCT01187498|Secondary|Percent Change in Frequency of Urge Incontinence|Percent change in frequency of urge incontinence episodes based on 7-day bladder diary. Percent change was calculated as ([frequency at baseline] - [frequency at 8 weeks]) / (frequency at baseline).|baseline to post-treatment (week 8)|Included participants who experienced incontinence at baseline only||Percent change in episodes per week||Standard Deviation|Mean
825184|NCT01187498|Secondary|Change in Urgency Severity|"Indevus Urgency Severity Scale incorporated into the 7-day bladder diary. Scores for urgency severity ranged from 0 to 3:
0: None—no urgency
Mild—awareness of urgency, but is easily tolerated.
Moderate—enough urgency discomfort that it interferes with or shortens usual activity
Severe—extreme urgency discomfort that abruptly stops all activities or tasks."|baseline to post-treatment (week 8)|Participants who completed treatment and returned bladder diary with useable urgency scores||Score on scale||Standard Deviation|Mean
825185|NCT01187498|Secondary|Change in Nocturia Frequency|Change in frequency of nocturia episodes based on 7-day bladder diary|baseline to post-treatment (week 8)|||nocturia episodes per night||Standard Deviation|Mean
825186|NCT01187498|Primary|24-hour Voiding Frequency|Mean voiding frequency per 24 hours derived from 7-day bladder dairy|post-treatment (week 8)|Treatment completers||voids per 24-hour day||Standard Deviation|Mean
825187|NCT01187511|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 7 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
825297|NCT01181726|Primary|AUC0-inf of Norethindrone(Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on Norethindrone AUC0-inf.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
825188|NCT01187511|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 4 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
825189|NCT01187511|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 32 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
825190|NCT01187511|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 28 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
825191|NCT01187511|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 25 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
825192|NCT01187511|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 21 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
825193|NCT01187511|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 18 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
825194|NCT01187511|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 14 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
825195|NCT01187511|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 11 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
825196|NCT01187511|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 1 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
825197|NCT01187511|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 7 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
825198|NCT01187511|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 4 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
825199|NCT01187511|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 32 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
825200|NCT01187511|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 28 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
825201|NCT01187511|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 25 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
825202|NCT01187511|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 21 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
825203|NCT01187511|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 18 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
825204|NCT01187511|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 14 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
825205|NCT01187511|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 11 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
825206|NCT01187511|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 1 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
825207|NCT01187511|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 7 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
825241|NCT01187550|Secondary|Change From Baseline in Fasting Glucose at Week 4||Baseline and Week 4|ITT population set included all the participants who received at least 1 dose of study medication. Here ‘N’ (Number of participants analyzed) signified those participants who were evaluable for this measure.||millimole/liter (mmol/L)||Standard Deviation|Mean
825208|NCT01187511|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 4 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
825209|NCT01187511|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 32 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
825210|NCT01187511|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 28 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
825211|NCT01187511|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 25 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
825212|NCT01187511|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 21 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
825213|NCT01187511|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 18 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
825214|NCT01187511|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 14 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
825215|NCT01187511|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 11 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
825216|NCT01187511|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 1 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
825242|NCT01187550|Secondary|Change From Baseline in Insulin Like Growth Factor Binding Protein-3 (IGFBP-3) Levels at Week 4||Baseline and Week 4|ITT population set included all the participants who received at least 1 dose of study medication.||microgram/mL (mcg/mL)||Standard Deviation|Mean
827280|NCT01203852|Secondary|Adverse Metabolic Effects|Change in glucose after treatment with study medication|after 6-8 weeks treatment|All patients with change in glucose data||mg/dL||Standard Deviation|Mean
825217|NCT01187511|Secondary|Alcohol Craving in Response to the Trier/Cue-reactivity Procedure|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|70 minutes after the beginning of the Trier/cue-reactivity procedure, which occurred on Day 21 of the treatment period|The analyses included only those subjects who completed the full Trier/cue-reactivity procedure||Units on a scale||Standard Error|Least Squares Mean
825218|NCT01187511|Secondary|Alcohol Craving in Response to the Trier/Cue-reactivity Procedure|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|40 minutes after the beginning of the Trier/cue-reactivity procedure, which occurred on Day 21 of the treatment period|The analyses included only those subjects who completed the full Trier/cue-reactivity procedure||Units on a scale||Standard Error|Least Squares Mean
825219|NCT01187511|Secondary|Alcohol Craving in Response to the Trier/Cue-reactivity Procedure|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|20 minutes after the beginning of the Trier/cue-reactivity procedure, which occurred on Day 21 of the treatment period|The analyses included only those subjects who completed the full Trier/cue-reactivity procedure||Units on a scale||Standard Error|Least Squares Mean
825220|NCT01187511|Secondary|Alcohol Craving in Response to the Trier/Cue-reactivity Procedure|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes prior to the beginning of the Trier/cue-reactivity procedure, which occurred on Day 21 of the treatment period|The analyses included only those subjects who completed the full Trier/cue-reactivity procedure||Units on a scale||Standard Error|Least Squares Mean
825221|NCT01187511|Secondary|Alcohol Craving in Response to the Trier/Cue-reactivity Procedure|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|100 minutes after the beginning of the Trier/cue-reactivity procedure, which occurred on Day 21 of the treatment period|The analyses included only those subjects who completed the full Trier/cue-reactivity procedure||Units on a scale||Standard Error|Least Squares Mean
825222|NCT01187511|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|90 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||Units on a scale||Standard Error|Least Squares Mean
825223|NCT01187511|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|75 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||Units on a scale||Standard Error|Least Squares Mean
825224|NCT01187511|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|60 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||Units on a scale||Standard Error|Least Squares Mean
825225|NCT01187511|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|5 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||Units on a scale||Standard Error|Least Squares Mean
825226|NCT01187511|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|45 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||Units on a scale||Standard Error|Least Squares Mean
825227|NCT01187511|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|30 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||Units on a scale||Standard Error|Least Squares Mean
825292|NCT01181726|Secondary|AUC0-t of Uncorrected Total Estrone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Informational comparison of AUC0-t values for Uncorrected Total Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
825228|NCT01187511|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes prior to the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||Units on a scale||Standard Error|Least Squares Mean
825229|NCT01187511|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||Units on a scale||Standard Error|Least Squares Mean
825230|NCT01187511|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|90 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||Units on a scale||Standard Error|Least Squares Mean
825231|NCT01187511|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|75 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||Units on a scale||Standard Error|Least Squares Mean
825232|NCT01187511|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|60 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||Units on a scale||Standard Error|Least Squares Mean
825233|NCT01187511|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|5 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||Units on a scale||Standard Error|Least Squares Mean
825234|NCT01187511|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|45 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||Units on a scale||Standard Error|Least Squares Mean
825235|NCT01187511|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|30 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||Units on a scale||Standard Error|Least Squares Mean
825236|NCT01187511|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes prior to the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||Units on a scale||Standard Error|Least Squares Mean
825237|NCT01187511|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||Units on a scale||Standard Error|Least Squares Mean
825238|NCT01187550|Secondary|Change From Baseline in Lipid Profile at Week 4|Total cholesterol, high-density lipoprotein (HDL)-cholesterol, low-density lipoprotein (LDL)-cholesterol and triglycerides levels were evaluated.|Baseline and Week 4|ITT population set included all the participants who received at least 1 dose of study medication. Here ‘N’ (Number of participants analyzed) signified those participants who were evaluable for this measure.||mmol/L||Standard Deviation|Mean
825239|NCT01187550|Secondary|Change From Baseline in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) Test at Week 4|HOMA-IR is used to assess insulin resistance and calculated by an empirical mathematical formula based on fasting plasma glucose and fasting plasma insulin levels. HOMA-IR = fasting plasma insulin (picomole/liter [pmol/L]) * fasting plasma glucose (millimole/liter [mmol/L]) divided by 22.5.|Baseline and Week 4|ITT population set included all the participants who received at least 1 dose of study medication. Here ‘N’ (Number of participants analyzed) signified those participants who were evaluable for this measure.||pmol/L*mmol/L||Standard Deviation|Mean
825243|NCT01187550|Primary|Change From Baseline in Serum Insulin Like Growth Factor-1 Standard Deviation Score (IGF-1 SDS) Levels at Week 4|Insulin Like Growth Factor-1 Standard Deviation Score (IGF-1 SDS) was calculated as logarithm (log) 10 actual value of IGF-1 - log 10 (mean reference value of IGF-1) divided by log10 reference standard deviation of IGF-1.|Baseline and Week 4|The intent-to-treat (ITT) population set included all the participants who received at least 1 dose of study medication.||nanogram/millilter (ng/mL)||Standard Deviation|Mean
825244|NCT01187771|Secondary|Mean 24-hour Diastolic Blood Pressure||9 months|||mmHg||Standard Deviation|Mean
825245|NCT01187771|Secondary|Direct Health Care Costs||9 months|Data not collected.|||||
825246|NCT01187771|Secondary|Depression (Patient Health Questionnaire-9)|The PHQ-9 is scored from 0-27 with higher scores indicating more severe depression.|9 months|||PHQ-9 scale||Standard Deviation|Mean
825247|NCT01187771|Secondary|Calgary Sleep Apnea Quality of Life Index|The Calgary Sleep Apnea Quality of Life Index results in scores ranging from 1-7, with higher scores indicating a higher quality of life.|9 months|||Units on Quality of Life Index||Standard Deviation|Mean
825248|NCT01187771|Secondary|Insulin Resistance (HOMA Index)||9 months|Data were not collected.|||||
825249|NCT01187771|Secondary|Mean 24-hour Systolic Blood Pressure||9 months|||mmHg||Standard Deviation|Mean
825250|NCT01187771|Primary|Epworth Sleepiness Score|The Epworth Sleepiness Scale results in scores ranging from 0-24, where scores of 0-10 indicate normal levels of sleepiness while 11-24 indicate excessive daytime sleepiness.|9 months|||Units on Epworth Sleepiness scale||Standard Deviation|Mean
825251|NCT01187771|Primary|Effective Apnea Hypopnea Index|The Effective Apnea Hypopnea Index (AHI) is the actual frequency of apneas and hypopneas per hour that the patient is exposed to. It is calculated as the AHI while on CPAP times the proportion of sleep time that CPAP was used plus the AHI off CPAP times the proportion of sleep time that CPAP is not used.|9 months|||Events per hour||Standard Deviation|Mean
825252|NCT01187901|Secondary|Change in Number of Duodenal Polyps From Baseline to 6 Months in Attenuated FAP Participants|A comparison between the Sulindac-erlotinib and Placebo arm Attenuated FAP subgroups of the change in number of polyps in a 10-centimeter segment of the duodenum (6-month polyp count minus baseline polyp count)|Baseline and 6 months|Attenuated FAP participants are defined with the presence of a mutation in a portion of the adenomatous polyposis coli (APC) gene known to correlate with attenuated FAP and presentation of a milder phenotype in terms of polyp density in the participant and the family. All participants with attenuated FAP had a confirmed mutation in the APC gene.||polyps||Inter-Quartile Range|Median
825253|NCT01187901|Secondary|Change in Number of Duodenal Polyps From Baseline to 6 Months in Classic FAP Participants|A comparison between the Sulindac-erlotinib and Placebo arm Classic FAP subgroups of the change in number of polyps in a 10-centimeter segment of the duodenum (6-month polyp count minus baseline polyp count)|Baseline and 6 months|Classic FAP participants are defined as those presenting with more than 100 colonic adenomas and either (1) multiple family members with a classic FAP phenotype or (2) an adenomatous polyposis coli (APC) mutation in a region of the gene known to correlate with Classic FAP, or (3) both||polyps||Inter-Quartile Range|Median
825254|NCT01187901|Secondary|Change in Number of Duodenal Polyps From Baseline to 6 Months|A comparison between the Sulindac-erlotinib and Placebo arms of the change in number of polyps in a 10-centimeter segment of the duodenum (6-month polyp count minus baseline polyp count).|Baseline and 6 months|||polyps||Inter-Quartile Range|Median
825255|NCT01187901|Secondary|Change in Duodenal Polyp Burden From Baseline to 6 Months in Attenuated FAP Participants|A comparison between the Sulindac-erlotinib and Placebo arm Attenuated FAP subgroups of the change in polyp burden from a 10-centimeter segment of the duodenum, measured as the sum of the diameters of the polyps, in millimeters (mm), from the duodenal segment (6-month polyp burden minus baseline polyp burden).|Baseline and 6 months|Attenuated FAP participants are defined with the presence of a mutation in a portion of the adenomatous polyposis coli (APC) gene known to correlate with attenuated FAP and presentation of a milder phenotype in terms of polyp density in the participant and the family. All participants with attenuated FAP had a confirmed mutation in the APC gene.||mm||Inter-Quartile Range|Median
825256|NCT01187901|Secondary|Change in Duodenal Polyp Burden From Baseline to 6 Months in Classic Familial Adenomatous Polyposis (FAP) Participants|A comparison between the Sulindac-erlotinib and Placebo arm Classic FAP subgroups of the change in polyp burden from a 10-centimeter segment of the duodenum, measured as the sum of the diameters of the polyps, in millimeters (mm), from the duodenal segment (6-month polyp burden minus baseline polyp burden).|Baseline and 6 months|Classic FAP participants are defined as those presenting with more than 100 colonic adenomas and either (1) multiple family members with a classic FAP phenotype or (2) an adenomatous polyposis coli (APC) mutation in a region of the gene known to correlate with Classic FAP, or (3) both.||mm||Inter-Quartile Range|Median
825257|NCT01187901|Primary|Change in Duodenal Polyp Burden From Baseline to 6 Months|A comparison between the Sulindac-erlotinib and Placebo arms of the change in polyp burden from a 10-centimeter segment of the duodenum, measured as the sum of the diameters of the polyps, in millimeters (mm), from the duodenal segment (6-month polyp burden minus baseline polyp burden).|Baseline and 6 months|||mm||Inter-Quartile Range|Median
825258|NCT01187914|Primary|Left Atrial (LA) Remodeling Pre-ablation|Utah staging for fibrosis (I - <=5%, II - 5.01%-20.0%, III - 20.01%-35% and IV - >=35.01%)|Once pre-ablation|||participants|||Number
825259|NCT01187953|Secondary|For the 24-month Analysis, the Endpoint Includes Additional Treatment Failures That Occurred During the 12-month Treatment Extension Period, up to Day 734 After the Randomization Date.|Treatment failure is a composite endpoint; a patient is considered a treatment failure if the patient experienced any of the following events during this period (day 1 to day 734): death, graft failure, BPAR (Banff grade ≥1A) or lost to follow-up.|734 days|All 543 randomized patients were included in the analysis population.||participants|||Number
825260|NCT01187953|Primary|The Primary Efficacy Endpoint for the Study is the Proportion of Treatment Failures Within 12 Months After Randomization to Study Drug.|Treatment failure is a composite endpoint; a patient is considered a treatment failure if the patient experienced any of the following events during this period: death, graft failure, BPAR (Banff grade ≥1A) or lost to follow-up.|360 days|All 543 randomized patients were included in the analysis population.||participants|||Number
828856|NCT01221441|Secondary|The Incidence and Severity of Adverse Events in Treated Patients|The incidence and severity of adverse events assessed through 104 weeks (2 years) after dose administration|2 Years|All patients receiving treatment with either active or placebo||participants|||Number
825261|NCT01188109|Secondary|Immunohistochemistry to Determine Status of Excision Repair Cross Complementation Gene-1 (ERCC1) Expression|To determine the level of ERCC1 expression, formalin-fixed, resected tumors were stained with anti-ERCC1 monoclonal antibody (clone 8F1; Neomarkers, Fremont, CA, USA) using the Dako Autostainer (Ft. Collins, CO). The percentage and intensity of fine granular nuclear staining were graded by a single pathologist. Percentage of staining was categorized into the following groups: 0 ≤ 1%; 1 = 1–10%; 2 = 11–50%; 3 = 51–100%. Staining intensity was scored as follows: 0 = none; 1 = weak; 2 = moderate; 3 = strong. Subsequently, an overall score to dichotomize the expression level to low or high was calculated: [(1+intensity score)/3]*percentage score. An overall score ≤ 2 was considered low ERCC1 expression, and > 2 was high ERCC1 expression.|At the time of resection|Twenty patients had tissue available for ERCC1 analysis.||patients|||Number
825262|NCT01188109|Primary|Recurrence-free Survival as Measured by CT Scan|Clinical data were prospectively collected. Staging was performed using 7th American Committee on Cancer criteria. Patients were followed by radiologic evaluation (CT or MRI) and carbohydrate antigen 19-9 (CA19-9) every 3 months for the first 3 years after resection to assess for recurrence. Subsequently, patients underwent imaging every 6 months.|Every 3 months and then every 6 months for 2 more years after resection|||months||95% Confidence Interval|Median
825263|NCT01188226|Secondary|Denture Teeth Calculus|Clinical evaluation of calculus for anterior teeth and posterior teeth on left and right sides on four-point scale (0= none; 1 = present on ≤ 1/3 of gingival margins; 2 = present on > 1/3 of gingival margins and parts of fissures and/or individual spots around cervical portion of tooth; 3 = covering more than ½ of gingival margins and the complete fissures and/or continuous heavy band of calculus around cervical portion of the tooth)|24 months after denture completion|For study participants who completed the 24-month follow-up. Anterior, right-posterior, and left-posterior denture teeth areas of each participant assessed and reported separately as Arms for this outcome.||participants|||Number
825264|NCT01188226|Secondary|Denture Teeth Calculus|Clinical evaluation of calculus for anterior teeth and posterior teeth on left and right sides on four-point scale (0= none; 1 = present on ≤ 1/3 of gingival margins; 2 = present on > 1/3 of gingival margins and parts of fissures and/or individual spots around cervical portion of tooth; 3 = covering more than ½ of gingival margins and the complete fissures and/or continuous heavy band of calculus around cervical portion of the tooth)|18 months after denture completion|For study participants who completed the 18-month follow-up. Anterior, right-posterior, and left-posterior denture teeth areas of each participant assessed and reported separately as Arms for this outcome.||participants|||Number
825265|NCT01188226|Secondary|Denture Teeth Calculus|Clinical evaluation of calculus for anterior teeth and posterior teeth on left and right sides on four-point scale (0= none; 1 = present on ≤ 1/3 of gingival margins; 2 = present on > 1/3 of gingival margins and parts of fissures and/or individual spots around cervical portion of tooth; 3 = covering more than ½ of gingival margins and the complete fissures and/or continuous heavy band of calculus around cervical portion of the tooth)|12 months after denture completion|For study participants who completed the 12-month follow-up. Anterior, right-posterior, and left-posterior denture teeth areas of each participant assessed and reported separately as Arms for this outcome.||participants|||Number
825266|NCT01188226|Secondary|Amount of Denture Teeth Plaque|Clinical evaluation of plaque for anterior teeth and left posterior teeth and right posterior teeth on four-point scale (0= none; 1 = soft debris covering ≤1/3 of tooth surface; 2 = soft debris covering > 1/3 and ≤ ½ of tooth surface; 3 = soft debris covering more than ½ of tooth surface)|24 months after denture completion|For study participants who completed the 24-month follow-up. Anterior, right-posterior, and left-posterior denture teeth areas of each participant assessed and reported separately as Arms for this outcome.||participants|||Number
825267|NCT01188226|Secondary|Amount of Denture Teeth Plaque|Clinical evaluation of plaque for anterior teeth and left posterior teeth and right posterior teeth on four-point scale (0= none; 1 = soft debris covering ≤1/3 of tooth surface; 2 = soft debris covering > 1/3 and ≤ ½ of tooth surface; 3 = soft debris covering more than ½ of tooth surface)|18 months after denture completion|For study participants who completed the 18-month follow-up. Anterior, right-posterior, and left-posterior denture teeth areas of each participant assessed and reported separately as Arms for this outcome.||participants|||Number
825268|NCT01188226|Secondary|Amount of Denture Teeth Plaque|Clinical evaluation of plaque for anterior teeth and left posterior teeth and right posterior teeth on four-point scale (0= none; 1 = soft debris covering ≤1/3 of tooth surface; 2 = soft debris covering > 1/3 and ≤ ½ of tooth surface; 3 = soft debris covering more than ½ of tooth surface)|12 months after denture completion|For study participants who completed the 12-month follow-up. Anterior, right-posterior, and left-posterior denture teeth areas of each participant assessed and reported separately as Arms for this outcome.||participants|||Number
825269|NCT01188226|Secondary|Denture Teeth Esthetics|Clinical evaluation of color deviation of anterior teeth to shade guide (3 levels: high, little, none)|24 months after denture completion|For study participants who completed the 24-month follow-up.||participants|||Number
825270|NCT01188226|Secondary|Denture Teeth Esthetics|Clinical evaluation of color deviation of anterior teeth to shade guide (3 levels: high, little, none)|18 months after denture completion|For study participants who completed the 18-month follow-up.||participants|||Number
825271|NCT01188226|Secondary|Denture Teeth Esthetics|Clinical evaluation of color deviation of anterior teeth to shade guide (3 levels, high, little none)|12 months after denture completion|For study participants who completed the 12-month follow-up.||participants|||Number
825272|NCT01188226|Secondary|Denture Teeth Calculus|Clinical evaluation of calculus for anterior teeth and posterior teeth on left and right sides on four-point scale (0= none; 1 = present on ≤ 1/3 of gingival margins; 2 = present on > 1/3 of gingival margins and parts of fissures and/or individual spots around cervical portion of tooth; 3 = covering more than ½ of gingival margins and the complete fissures and/or continuous heavy band of calculus around cervical portion of the tooth)|6 months after denture completion|For study participants who completed the 6-month follow-up. Anterior, right-posterior, and left-posterior denture teeth areas of each participant assessed and reported separately as Arms for this outcome.||participants|||Number
825293|NCT01181726|Secondary|Cmax of Uncorrected Total Estrone(Maximum Observed Concentration of Drug Substance in Plasma)|Informational comparison of Cmax values for Uncorrected Total Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg/mL||Standard Deviation|Mean
825273|NCT01188226|Secondary|Amount of Denture Teeth Plaque|Clinical evaluation of plaque for anterior teeth and left posterior teeth and right posterior teeth on four-point scale (0= none; 1 = soft debris covering ≤1/3 of tooth surface; 2 = soft debris covering > 1/3 and ≤ ½ of tooth surface; 3 = soft debris covering more than ½ of tooth surface)|6 months after denture completion|For study participants who completed the 6-month follow-up. Anterior, right-posterior, and left-posterior denture teeth areas of each participant assessed and reported separately as Arms for this outcome.||participants|||Number
825274|NCT01188226|Secondary|Denture Teeth Esthetics|Clinical evaluation of color deviation of anterior teeth to shade guide (3 levels: high, little, none)|6 months after denture completion|||participants|||Number
825275|NCT01188226|Primary|Location of Posterior Denture Tooth Wear|Clinical evaluation of posterior wear location (right, left, equal)|24 months after denture completion|For study participants who completed the 24-month follow-up. Upper and lower dentures of each participant assessed and reported separately as Arms for this outcome.One participant had the lower denture refabricated after 12 months and was not included in 24-month lower-denture assessment||participants|||Number
825276|NCT01188226|Primary|Location of Posterior Denture Tooth Wear|Clinical evaluation of posterior wear location (right, left, equal)|18 months after denture completion|For study participants who completed the 18-month follow-up. Upper and lower dentures of each participant assessed and reported separately as Arms for this outcome.One participant had the lower denture refabricated after 12 months and was not included in 18-month lower-denture assessment||participants|||Number
825277|NCT01188226|Primary|Location of Posterior Denture Tooth Wear|Clinical evaluation of posterior wear location (right, left, equal)|12 months after denture completion|For study participants who completed the 12-month follow-up. Upper and lower dentures assessed and reported separately as Arms for this outcome.||participants|||Number
825278|NCT01188226|Primary|Location of Posterior Denture Tooth Wear|Clinical evaluation of posterior wear location (right, left, equal).|6 months after denture completion|For study participants who completed the 6-month follow-up. Upper and lower dentures of each participant assessed and reported separately as Arms for this outcome.||participants|||Number
825279|NCT01181726|Secondary|AUC0-inf of Corrected Unconjugated Estrone(Area Under the Concentration-time Curve From Time Zero to Infinity)|Informational comparison of AUC0-inf values for Corrected Unconjugated Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
825280|NCT01181726|Secondary|AUC0-t of Corrected Unconjugated Estrone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Informational comparison of AUC0-t values for Corrected Unconjugated Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
825281|NCT01181726|Secondary|Cmax of Corrected Unconjugated Estrone(Maximum Observed Concentration of Drug Substance in Plasma)|Informational comparison of Cmax values for Corrected Unconjugated Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg/mL||Standard Deviation|Mean
825282|NCT01181726|Secondary|AUC0-inf of Corrected Unconjugated Estradiol(Area Under the Concentration-time Curve From Time Zero to Infinity)|Informational comparison of AUC0-inf values for Corrected Unconjugated Estradiol.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
825283|NCT01181726|Secondary|AUC0-t of Corrected Unconjugated Estradiol(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Informational comparison of AUC0-t values for Corrected Unconjugated Estradiol.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
825284|NCT01181726|Secondary|Cmax of Corrected Unconjugated Estradiol(Maximum Observed Concentration of Drug Substance in Plasma)|Informational comparison of Cmax values for Corrected Unconjugated Estradiol.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg/mL||Standard Deviation|Mean
825285|NCT01181726|Secondary|AUC0-inf of Uncorrected Unconjugated Estrone(Area Under the Concentration-time Curve From Time Zero to Infinity)|Informational comparison of AUC0-inf values for Uncorrected Unconjugated Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
825286|NCT01181726|Secondary|AUC0-t of Uncorrected Unconjugated Estrone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Informational comparison of AUC0-t values for Uncorrected Unconjugated Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
825287|NCT01181726|Secondary|Cmax of Uncorrected Unconjugated Estrone(Maximum Observed Concentration of Drug Substance in Plasma)|Informational comparison of Cmax values for Uncorrected Unconjugated Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg/mL||Standard Deviation|Mean
825288|NCT01181726|Secondary|AUC0-inf of Uncorrected Unconjugated Estradiol(Area Under the Concentration-time Curve From Time Zero to Infinity)|Informational comparison of AUC0-inf values for Uncorrected Unconjugated Estradiol.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
825289|NCT01181726|Secondary|AUC0-t of Uncorrected Unconjugated Estradiol(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Informational comparison of AUC0-t values for Uncorrected Unconjugated Estradiol.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
825290|NCT01181726|Secondary|Cmax of Uncorrected Unconjugated Estradiol(Maximum Observed Concentration of Drug Substance in Plasma)|Informational comparison of Cmax values for Uncorrected Unconjugated Estradiol.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg/mL||Standard Deviation|Mean
825291|NCT01181726|Secondary|AUC0-inf of Uncorrected Total Estrone(Area Under the Concentration-time Curve From Time Zero to Infinity)|Informational comparison of AUC0-inf values for Uncorrected Total Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
825298|NCT01181726|Primary|AUC0-t of Norethindrone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on Norethindrone AUC0-t.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
825299|NCT01181726|Primary|Cmax of Norethindrone (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Norethindrone Cmax.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
825300|NCT01181778|Secondary|Percentage of Participants With Post-counseling Contacts With Physician Offices, by Hormonal Contraceptive Method|Participant contacts with physician offices were collected, and the number of callbacks by method of contraception recorded. Participants who called back more than once were counted overall and for each method of contraception.|Up to four months after the counseling visit|The analysis population consisted of all participants who completed questionnaires before and after physician counseling and had no medical reason to prevent them from using a combined hormonal contraception method.||percentage of participants|||Number
825301|NCT01181778|Primary|Number of Participants Choosing Each Hormonal Contraceptive Method Before and After Counseling|Before receiving counseling, participants recorded on a questionnaire the method of contraception they thought they would choose. This was to be compared with the method of contraception the same participants thought they would choose after they received physician counseling, which was also recorded on their questionnaire.|Day of inclusion (Day 0) prior to physician counseling and after physician counseling|The analysis population consisted of all participants who completed questionnaires before and after physician counseling and had no medical reason to prevent them from using a combined hormonal contraception method.||Participants|||Number
825302|NCT01181804|Primary|t1/2 Boceprevir in Fasted State|T1/2 is the time required for a given drug concentration to decrease by 50%.|Predose through 72 hours post-dose|Analysis is per protocol; all available data are included in the model. No imputation is used for missing data.||hours||Standard Deviation|Mean
825303|NCT01181804|Primary|Half Life (t1/2) of Boceprevir in Fed State|T1/2 is the time required for a given drug concentration to decrease by 50%.|Predose through 72 hours post-dose|Analysis is per protocol; all available data are included in the model. No imputation is used for missing data.||hours||Standard Deviation|Mean
825304|NCT01181804|Primary|AUCinf in Fasted State|AUC is the measure of total plasma exposure of a drug over a given time period. AUC is derived from the area under the plasma drug concentration-time curve.|Predose through 72 hours post-dose|Analysis is per protocol; all available data are included in the model. No imputation is used for missing data.||ng*hr/mL||90% Confidence Interval|Geometric Mean
825305|NCT01181804|Primary|AUC From Hour 0 to Infinity (AUCinf) in Fed State|AUC is the measure of total plasma exposure of a drug over a given time period. AUC is derived from the area under the plasma drug concentration-time curve.|Predose through 72 hours post-dose|Analysis is per protocol; all available data are included in the model. No imputation is used for missing data.||ng*hr/mL||90% Confidence Interval|Geometric Mean
825306|NCT01181804|Primary|Cmax of Boceprevir Tablets Versus Capsules in Fasted State|Cmax is the highest plasma drug concentration observed on the plasma concentration-time curve.|Predose through 72 hours post-dose|Analysis is per protocol; all available data are included in the model. No imputation is used for missing data.||ng/mL||90% Confidence Interval|Geometric Mean
825307|NCT01181804|Primary|AUCtf for Boceprevir Tablets Versus Capsules in Fasted State|AUC is the measure of total plasma exposure of a drug over a given time period. AUC is derived from the area under the plasma drug concentration-time curve.|Predose through 72 hours post-dose|Analysis is per protocol; all available data are included in the model. No imputation is used for missing data.||ng*hr/mL||90% Confidence Interval|Geometric Mean
825308|NCT01181804|Primary|Maximum Plasma Concentration (Cmax) of Boceprevir Tablets Versus Capsules in Fed State|Cmax is the highest plasma drug concentration observed on the plasma concentration-time curve.|Predose through 72 hours post-dose|Analysis is per protocol; all available data are included in the model. No imputation is used for missing data.||ng*hr/mL||90% Confidence Interval|Geometric Mean
825309|NCT01181804|Primary|Area Under the Concentration Curve (AUC) From Hour 0 to the Final Quantifiable Sample (AUCtf) for Boceprevir Tablets Versus Capsules in Fed State|AUC is the measure of total plasma exposure of a drug over a given time period. AUC is derived from the area under the plasma drug concentration-time curve.|Predose through 72 hours post-dose|Analysis is per protocol; all available data are included in the model. No imputation is used for missing data.||ng*hr/mL||90% Confidence Interval|Geometric Mean
825310|NCT01181895|Secondary|Number of Participants With the Indicated Global Assessment of Change Questionnaire Responses at the End of Week 4 and Week 12|At the end of Week 4 and Week 12, the Global Assessment of Change Questionnaire, which assesses changes in asthma symptoms and rescue medication use, was completed by participants using the following scale: asthma symptom (AS) change: much better, somewhat better, a little better, the same, a little worse, somewhat worse, much worse; rescue medication use (RMU): much less often , somewhat less often , a little less often , the same , a little more often , somewhat more often , much more often.|Week 4 and Week 12|ITT Population. Only those participants available at the indicated time points were assessed.||Participants|||Number
825311|NCT01181895|Secondary|Number of Participants With the Indicated Time to an Increase of >=12% and >=200 Milliliters (mL) Above Baseline in FEV1 on Day 1 and Day 84 (0-2 Hours)|The number of participants with a >=12% and >=200 mL increase from Baseline in FEV1 (the maximal amount of air that can be forcefully exhaled in one second) was evaluated on Day 1 and Week 12 for the time to a >=12% increase from Baseline (at the 5 minutes (min), 15 min, 30 min, 1hour (hr), and 2 hr nominal time points. Participants who did not achieve a >=12% and >=200 mL increase from Baseline in FEV1 over this time period were considered censored.|Day 1 and Week 12|ITT Population. Only those participants available at the indicated time points were assessed.||Participants|||Number
825323|NCT01181986|Secondary|Plasma Glucose|Plasma glucose was measured before and 2, 4, 6 and 8 hours following study drug administration. Results are expressed as least-square means of ANCOVA models adjusted for sampling time and intervention sequence.|0, 2, 4, 6, and 8 hours post-study drug on day 11|||mg/dl||Standard Error|Least Squares Mean
825324|NCT01181986|Secondary|Plasma Triglycerides|Triglycerides concentrations were measured before and 2, 4, 6 and 8 hours following study drug. Results are expressed as least-square means of ANCOVA models adjusted for sampling time and intervention sequence.|0, 2, 4, 6 and 8 hours post-study drug on day 11|||mg/dl||Standard Error|Least Squares Mean
825312|NCT01181895|Secondary|Change From Baseline in Daily AM (Morning) PEF Averaged Over the 12-week Treatment Period|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Trough PEF is the PEF measured approximately 24 hours after the last administration of study drug. The Baseline value is the average value of the last 7 days of daily AM PEF prior to randomization. Change from Baseline in trough AM PEF was calculated as the averaged value of all daily AM PEF for Weeks 1 to Week 12 minus the value at Baseline. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|Baseline and Weeks 1-12|ITT Population. Only those participants available at the indicated time points were assessed.||Liters per minute (L/min)||Standard Error|Least Squares Mean
825313|NCT01181895|Secondary|Change From Baseline in Daily Trough (Pre-dose and Pre-rescue Bronchodilator) PM (Evening) Peak Expiratory Flow (PEF) Averaged Over the 12-week Treatment Period|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Trough PEF is the PEF measured approximately 24 hours after the last administration of study drug. The Baseline value is the average value of the last 7 days of daily PM PEF prior to randomization. Change from Baseline in trough PM PEF was calculated as the averaged value of all daily PM PEF for Week 1 to Week 12 minus the value at Baseline. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|Baseline and Weeks 1-12|ITT Population. Only those participants available at the indicated time points were assessed.||Liters per minute (L/min)||Standard Error|Least Squares Mean
825314|NCT01181895|Secondary|Change From Baseline in Individual Serial FEV1 Assessments at the End of the 12-week Treatment Period, Including the 12-hour and 24-hour Time Points|FEV1 is a measure of lung function and is defined as the volume of air that can be forcefully exhaled in one second. The individual serial FEV1 is calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5, 15, 30, and 60 minutes (min) and 2, 3, 5, 11, 12, 12.5, 13, 14, 16, 20, 23, and 24 hours, relatively, on Treatment Day 84 (Week 12). The Baseline value was the Day 1 pre-dose FEV1 measurement. Change from Baseline was calculated as the value of the individual serial FEV1 taken at Week 12 minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline FEV1, region, sex, age, and treatment. Analysis was performed separately for each planned time point.|Baseline and Week 12|ITT Population. Only those participants available at the indicated time points were assessed.||Liters||Standard Error|Least Squares Mean
825315|NCT01181895|Secondary|Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 12-week Treatment Period|Participants who were symptom free for 24-hour periods during the12-week treatment period were assessed. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant (including the day of randomization). Change from Baseline is calculated as the value at Weeks 1-12 minus the value at Baseline. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|Baseline and Weeks 1-12|ITT Population. Only those participants available at the indicated time points were assessed.||Percentage of symptom-free 24-hr periods||Standard Error|Least Squares Mean
825316|NCT01181895|Secondary|Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods During the 12-week Treatment Period|The time span during which the participants did not have to take any rescue bronchodilator (medication intended to relieve symptoms immediately) was considered to be a rescue-free period. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant (including the day of randomization). Change from Baseline is calculated as the value at Weeks 1-12 minus the value at Baseline. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|Baseline and Weeks 1-12|ITT Population. Only those participants available at the indicated time points were assessed.||Percentage of rescue-free 24-hr periods||Standard Error|Least Squares Mean
825317|NCT01181895|Primary|Change From Baseline in Weighted-mean 24-hour Serial Forced Expiratory Volume in One Second (FEV1) at Week 12|FEV1 is a measure of lung function and is defined as the volume of air that can be forcefully exhaled in one second. The weighted mean is calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5, 15, and 30 minutes (min) and at 1, 2, 3, 4, 11, 12, 12.5, 13, 14, 16, 20, 23, and 24 hours, respectively, at Week 12. The Baseline value was the Day 1 pre-dose FEV1 measurement. Change from Baseline is calculated as the weighted mean 0-24 hour FEV1 (Liters) at Week 12 minus the Baseline value. Analysis was performed using analysis of covariance (ANCOVA) with covariates of Baseline FEV1, region, sex, age, and treatment.|Baseline and Week 12|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study medication. Only those participants available at the indicated time point were assessed.||Liters||Standard Error|Least Squares Mean
825318|NCT01181921|Primary|Change From Baseline in Sleep/Wake Patterns as Measured by Actigraph at 12 Weeks|Actigraph is a small portable device that is worn on the wrist of the non-dominant arm to measure body movement during long time periods. It creates a pattern based on activity that is useful in assessing sleep-wake cycles across many consecutive days and nights. It is useful for assessing sleep phase disorders.|Baseline and 12 weeks|Only one participant was recruited and did not complete the study; therefore no assessments have been conducted throughout the study.|||||
825319|NCT01181947|Primary|Technical Success at Time of Initial Implant|Technical success is defined as successful delivery and deployment of the stent graft (assessed intraoperatively). This is achieved by deployment of the Valiant Thoracic Stent Graft in the planned location with no unintentional coverage of the left subclavian artery, left common carotid artery and/or brachiocephalic artery and with the removal of the delivery system|intraoperatively|"The primary and secondary endpoints will be reported descriptively.
By-gender and by-race data summaries for the primary endpoints, if appropriate, will be generated. Data from all study sites will be grouped together for analyses."||participants||95% Confidence Interval|Number
825320|NCT01181947|Secondary|ACM and ARM|All-cause (ACM), Aneurysm related (ARM) and dissection related mortality|at 30 days, 12 months, 24 months and 36 months||||||
825321|NCT01181947|Secondary|SAE|Serious Adverse Events (SAE)|through 12 months|"The primary and secondary endpoints will be reported descriptively.
By-gender and by-race data summaries for the primary endpoints, if appropriate, will be generated. Data from all study sites will be grouped together for analyses."||participants||95% Confidence Interval|Number
825322|NCT01181947|Primary|Treatment Success|"technical success and freedom from
TAA diameter increase of stented segment (>5mm compared to 1 mo),
Types I/III endoleak,
Aneurysm rupture,
Conversion to open surgery,
Stent graft occlusion,
Stent graft migration resulting in SAE or secondary intervention."|at 30 days, 12 months, 24 months and 36 months||||||
825325|NCT01181986|Primary|Reactive Hyperemia Index (RHI)|Greater RHI reflects greater endothelial function. It is calculated as average post-ischemia pulse magnitude divided by average pre-ischemia pulse magnitude. Results are expressed as least-square means of ANCOVA models.|0, 2, 4, 6 and 8 hours on Day 11 (Sub-study 1); 0 and 120 minutes on test Days 1, 2 & 3 (Sub-study 2)|||ratio||Standard Error|Least Squares Mean
825326|NCT01182103|Secondary|BDNF Levels of MDD Patients Before and After Treatment and Healthy Controls|"Serum BDNF levels were measured. MDD patients received antidepressant treatment, a standard biological management. Nothing novel (such as experimental drugs or management) is introduced in the treatment, so the research design is observational (of standard treatment).
The choice of antidepressant drugs depended on the need of patients in natural treatment procedure. They included selective serotonin reuptake inhibitors (SSRI), eg. fluoxetine or paroxetine."|2 years|||ng/ml||Standard Deviation|Mean
825327|NCT01182103|Primary|Histone Modification of MDD Patients Before and After Treatment and With Healthy Controls|"Chromatin immunoprecipitation (ChIP) was used to measure histone modification. The unit of our given machine is relative quantification, and a higher value indicated increased histone modification. The detailed method could be found in:
Huebert DJ, Kamal M, O’Donovan A, Bernstein BE: Genome-wide analysis of histone modifications by ChIP-on-chip. Methods 2006; 40: 365–369."|2 years|||relative quantification||Standard Deviation|Mean
825328|NCT01182103|Primary|Brain-derived Neurotrophic Factor (BDNF) DNA Methylation of Major Depressive Disorder (MDD) Patients and Healthy Controls|averaged percentage of methylation at each CpG site listed|2 years|Only 39 out of the 48 MDD patients provided enough blood sample for this analysis.||percent||Standard Deviation|Mean
825329|NCT01182181|Primary|AUC0-t of Anastrozole(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on Anastrozole AUC0-t.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
825330|NCT01182181|Primary|Cmax of Anastrozole(Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Anastrozole Cmax.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
825331|NCT01188343|Secondary|Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine|Solicited injection site: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, and Irritability. Grade 3 injection site: Pain - Cries when injected limb is moved or movement of limb is reduced; Erythema and Swelling - ≥5 cm. Grade 3 systemic reactions: Fever - >39.5°C; Vomiting - ≥6 episodes per 24 hours or requiring parenteral hydration; Crying Abnormal - >3 hours; Drowsiness - Sleeping most of the time or difficult to wake; Appetite Lost - Refused ≥3 feeds/meals or refused most feeds/meals; Irritability - Inconsolable.|Day 0 up to Day 14 post-vaccination|Solicited injection site and systemic events were assessed in all randomized and vaccinated participants, the Safety Analysis Set.||Participants|||Number
825332|NCT01188343|Other Pre-specified|Serological Status of Flavivirus at Before (Baseline) Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine|Neutralizing antibodies levels against dengue were only evaluated on subjects ELISA positive for Immunoglobulin G (IgG) or Immunoglobulin M (IgM). Flavivirus positive was defined as antibodies against JE-CV virus ≥10 (l/dil) or antibodies against at least one dengue virus serotype ≥10 (l/dil); Flavivirus negative was defined as antibodies against JE CV virus < 10 (l/dil) and antibodies against the 4 dengue virus serotypes < 10 (l/dil).|Day 0 (pre-vaccination)|Serological status of Flavivirus infection was assessed in the Full Analysis Set.||Participants|||Number
825333|NCT01188343|Secondary|Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine|Solicited injection site: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, and Irritability. Grade 3 injection site: Pain - Cries when injected limb is moved or movement of limb is reduced; Erythema and Swelling - ≥5 cm. Grade 3 systemic reactions: Fever - >39.5°C; Vomiting - ≥6 episodes per 24 hours or requiring parenteral hydration; Crying Abnormal - >3 hours; Drowsiness - Sleeping most of the time or difficult to wake; Appetite Lost - Refused ≥3 feeds/meals or refused most feeds/meals; Irritability - Inconsolable.|Day 0 up to Day14 post-vaccination|Solicited injection site and systemic events were assessed in all randomized and vaccinated participants, the Safety Analysis Set.||Participants|||Number
825334|NCT01188343|Secondary|Geometric Mean Titers of Antibodies to Vaccine Antigens Before and After Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine|JE-CV antigens were measured using a 50% plaque reduction neutralization test (PRNT50); MMR antigens were measured using enzyme linked immunosorbent assay (ELISA).|Pre-vaccination and Day 42 post-vaccination|Geometric mean titers were assessed in the Per Protocol Analysis Set population with evaluable data.||Titers||95% Confidence Interval|Geometric Mean
825335|NCT01188343|Secondary|Number of Participants With Seroprotection to JE-CV and MMR Antigens Before, at Month 6 After Last Vaccination and Month 12 After First Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine|JE-CV antigens were measured using a 50% plaque reduction neutralization test (PRNT50); MMR antigens were measured using enzyme linked immunosorbent assay (ELISA). Seroprotection was defined as: for JE-CV - participants with a pre-vaccination titer <1/10 (1/dil) and post-vaccination titer ≥1/10, (1/dil) or a pre-vaccination titer ≥1/10 and 4-fold increase from pre- to post; for Measles - post-vaccination titer ≥120 mIU/ml, when pre-vaccination titer is <120 mIU/ml; for Mumps - post-vaccination titer ≥1/10 units/ml when pre-vaccination titer is <10 units/ml; and for Rubella, post-vaccination titer ≥1/10 IU/ml when pre-vaccination titer is <10 IU/m|Pre-vaccination and up to Month 12 post-vaccination|Seroprotection to JE-CV and to MMR vaccine antigen was assessed in all participants who were randomized, vaccinated and who performed all protocol defined activities the Full Analysis Set.||Participants|||Number
825350|NCT01188551|Primary|FLACC Behavioral Pain Assessment Scale Scores|"FLACC Behavioral Pain Assessment Scale: each of the five categories (F) Face, (L) Legs, (A) Activity, (C) Cry, (C) Consolability is scored from 0-2, which results in a total score between 0 and 10.
0 = Relaxed and comfortable 1–3 = Mild discomfort 4–6 = Moderate pain 7–10 = Severe discomfort or pain or both"|30 mins. post-op|||units on a scale||Standard Deviation|Mean
825351|NCT01188564|Secondary|Time to Minimal Symptoms|"The key secondary efficacy endpoint was the time to minimal symptoms at all locations. The time to achieving minimal symptoms was defined as an answer of Yes to TEQ question 3."|24 hours|||minutes||Full Range|Median
825336|NCT01188343|Secondary|Percentage of Participants With Seroconversion to JE-CV and MMR Antigens Before and 42 Days Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine|JE-CV antigens were measured using a 50% plaque reduction neutralization test (PRNT50); MMR antigens were measured using enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as: for JE-CV - participants with a pre-vaccination titer <1/10 and post-vaccination titer ≥1/10, or a pre-vaccination titer ≥1/10 and 4-fold increase from pre- to post; for Measles - post-vaccination titer ≥120 mIU/ml, when pre-vaccination titer is <120 mIU/ml; for Mumps - post-vaccination titer ≥1/10 U/ml when pre-vaccination titer is <10 U/ml; and for Rubella, post-vaccination titer ≥1/10 U/ml when pre-vaccination titer is <10 U/m|Pre-vaccination and Day 42 post-vaccination|Seroconversion to JE-CV and to MMR vaccine antigen was assessed in all participants who were randomized, vaccinated, who performed all protocol defined activities and has evaluable data (Per-protocol Analysis Set).||Percentage of Participants|||Number
825337|NCT01188343|Primary|Percentage of Participants With Seroconversion to Vaccine Antigens Following Concomitant Administration of Japanese Encephalitis Chimeric Virus Vaccine (JECV) and MMR or Single Administration of JE-CV and MMR Vaccine at 42 Days Following First Vaccination|JE-CV antigens were measured using a 50% plaque reduction neutralization test (PRNT50); MMR antigens were measured using enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as: for JE-CV - participants with a pre-vaccination titer <1/10 and post-vaccination titer ≥1/10, or a pre-vaccination titer ≥1/10 and 4-fold increase from pre- to post; for Measles - post-vaccination titer ≥120 mIU/ml, when pre-vaccination titer is <120 mIU/ml; for Mumps - post-vaccination titer ≥1/10 U/ml when pre-vaccination titer is <10 U/ml; and for Rubella, post-vaccination titer ≥1/10 U/ml when pre-vaccination titer is <10 U/ml.|Day 0 (pre-vaccination) and Day 42 post-vaccination|Seroconversion was assessed in the Per Protocol Analysis Set with evaluable data.||Percentage of Participants|||Number
825338|NCT01188421|Primary|Mean Ratings on Clinical Opiate Withdrawal Scale (COWS) Measure of Withdrawal During Double-blind Taper (7-days) and Post-taper (7-days) Period.|Outcomes represent mean peak withdrawal as rated on the Clinical Opiate Withdrawal Scale (COWS) total score. Withdrawal was collected 7 times daily and daily peak values were identified for each participant and averaged together as a function of group. Primary outcomes were mean peak results from the 7-day taper period and first 7 days post-taper. The COWS is an 11-item observer-rated measure of opioid withdrawal severity. Items are rated on individual Likert scales and the total score range is 0-47. Higher values indicate more severe withdrawal.|14 days total|Repeated measures ANOVA||units on a scale||Standard Error|Mean
825339|NCT01188447|Secondary|Average Contact Time|Total time spent with patient (Defined as difference between Transfer of Care and Arrival at Patient Side)|immediately following evaluation|In order to be included in this analysis, and to have Contact Time calculated, both the paramedic arrival time and transfer of care time were required. Any case missing this information could not be included in the calculation.||minutes||Full Range|Mean
825340|NCT01188447|Secondary|Scene Time|Time spent at scene (difference between Paramedic scene departure and arrival at patient side)|immediately following evaluation|In order to be included in this analysis, a valid time for paramedic arrival and paramedic scene departure were required. Any patient refusing transport or missing time information was not included in the analysis.||Minutes||Full Range|Mean
825341|NCT01188447|Secondary|Performance of the Canadian C-Spine Rule|"Measurements of the performance of the rule will include:
rule accuracy
paramedic accuracy of interpretation
paramedic agreement and level of comfort with the decision suggested by the Canadian C-Spine Rule"|Rule accuracy will be within 30 days of enrollment. Paramedic accuracy of interpretation and agreement will be assessed immediately following enrollment.|||percentage of injuries identified||95% Confidence Interval|Number
825342|NCT01188447|Secondary|Clearance Rate|Proportion of eligible low-risk patients transported without immobilization|Measures of clinical impact will be assessed immediately following the patient's Emergency Department visit|||Participants|||Count of Participants
825343|NCT01188447|Primary|Adverse Events|"Measures of safety will include:
number of missed cervical spine injuries
number of serious adverse outcomes"|within 30 days of enrollment|||Adverse event|||Number
825344|NCT01188499|Secondary|Evaluation of Pharmacokinetics and Translational Biomarkers|Measurement of TL32711 pharmacokinetics: Maximum plasma concentration (Cmax), area under the curve (AUC), half-life (t1/2) and assessment of translational biomarkers in plasma, PBMC's and tumor biopsies. Gene expression profiling of tumor tissue.|Cycle 1 and Cycle 2||||||
825345|NCT01188499|Secondary|Evaluation of Anti-tumor Efficacy|Tumor burden according to Response Evaluation Criteria in Solid Tumors (RECIST) and time to progression|Every 2 cycles|Intent-to-treat (ITT)||participants|||Number
825346|NCT01188499|Primary|Number of Subjects With Adverse Events as a Measure of Safety and Tolerability|Number of subjects with adverse events as a measure of safety and tolerability including changes in vital signs, electrocardiograms (ECGs), safety and laboratory parameters|1 Cycle (3-4 weeks)|||participants|||Number
825347|NCT01188538|Secondary|Percent Change (%) in Inflammatory Lesion Counts|Inflammatory lesions were counted and recorded by the Evaluator (Investigator or designee) at Baseline and at Week 12. Based on these counts at Baseline and Week 12, Percent change (%) from Baseline in inflammatory lesion counts at Week 12 was calculated.|Week 12|ITT (LOCF)||Percent change (%)||Full Range|Median
825348|NCT01188538|Primary|Change From Baseline (Log10 Cfu/cm²) in Count of Follicular P. Acnes|"Quantitative bacterial examinations were performed on the subjects’ face during the study. These samplings were performed using a method to quantify the follicular microbiological flora of the skin (at Baseline and Week 12 visits).This method consists of a technique allowing the extraction of the outermost layer of epidermis from hair follicle on the cheek and to culture the samplings in order to have the number of P. acnes.
Outcome measure = Change from baseline (Log10 cfu/cm²) in count of Follicular P. acnes at end of the study."|Week 12|Intent To Treat (ITT)/Last Observation Carried Forward (LOCF)||Log10 cfu/cm²||Standard Deviation|Mean
825349|NCT01188551|Secondary|Recovery From General Anesthesia|Post-anesthesia recovery score: Aldrete The Aldrete scoring system takes into account the patient's ability to move, respiration, circulation, consciousness, and oxygen saturation. A maximum of two points are awarded in each category and a score of 9 or 10 is required for discharge.|30 mins. post-op|||units on a scale||Standard Deviation|Mean
825384|NCT01190436|Primary|Percentage of Participants With Decrease in Heart Rate by at Least 10 Bpm at Week 12||Week 12|ITT population included all participants who received at least 1 dose of study drug.||percentage of participants|||Number
825352|NCT01188564|Primary|Time to Beginning of Relief of Symptoms|"Time to beginning of relief is the time lapsed from the beginning of the infusion of study medication to the beginning of a beneficial effect based on patient's responses to the Treatmetn Effect Questionnaire (TEQ) for the primary attack location. The beginning of relief is defined as the first timepoint at which
The patient reports any of the following answers for TEQ question 1: A little better, Better or Much better; and;
The patient reports the following answer for TEQ question 2: Yes; and,
There is persistence in improvement at the next assessment time, i.e.either the same or a better response to Question 1 and Yes to Question 2."|Patients observed for 24 hours|||minutes||95% Confidence Interval|Median
825353|NCT01188577|Primary|Concentration vs. Time for Total Epinephrine From Time Zero to 6 Hours Post-dose|Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 2, 5, 7.5, 10, 12.5, 15, 20, 25, 30, 45, 60, 90, 120, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method.|Pre-dose to 6 hours post-dose|Patients who: 1) have taken the valid pre-dose baseline PK sample 2) have correctly taken the randomized study drug treatment 3) have at least three of the four post-dose PK measurements btw 2 and 10 min post-dose available and 4) have a minimum of twelve of the fifteen post-dose PK measurements for the entire 6 hour post-dose PK sampling period.||pg/mL||Standard Deviation|Mean
825354|NCT01188577|Primary|Half-life (t1/2) of Total Epinephrine|Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 2, 5, 7.5, 10, 12.5, 15, 20, 25, 30, 45, 60, 90, 120, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Half-life (t1/2) is the amount of time it takes for epinephrine to decrease to half the peak concentration in plasma during the treatment period.|Pre-dose to 6 hours post-dose|Patients who: 1) have taken the valid pre-dose baseline PK sample 2) have correctly taken the randomized study drug treatment 3) have at least three of the four post-dose PK measurements btw 2 and 10 min post-dose available and 4) have a minimum of twelve of the fifteen post-dose PK measurements for the entire 6 hour post-dose PK sampling period.||min||Full Range|Mean
825355|NCT01188577|Primary|Time to Reach Peak Concentration (Tmax) for Total Epinephrine|Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 2, 5, 7.5, 10, 12.5, 15, 20, 25, 30, 45, 60, 90, 120, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Tmax is the amount of time it takes for epinephrine to reach peak concentration in plasma during the treatment period.|Pre-dose to 6 hours post-dose|Patients who: 1) have taken the valid pre-dose baseline PK sample 2) have correctly taken the randomized study drug treatment 3) have at least three of the four post-dose PK measurements btw 2 and 10 min post-dose available and 4) have a minimum of twelve of the fifteen post-dose PK measurements for the entire 6 hour post-dose PK sampling period.||min||Standard Deviation|Mean
825356|NCT01188577|Primary|Area Under the Curve From Time Zero to 6 Hours Post-dose (AUC[0-6]) for Total Epinephrine|Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 2, 5, 7.5, 10, 12.5, 15, 20, 25, 30, 45, 60, 90, 120, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Area under the curve from time zero to 6 hours post-dose (AUC[0-6]) was calculated using the trapezoidal rule.|Pre-dose to 6 hours post-dose|Patients who: 1) have taken the valid pre-dose baseline PK sample 2) have correctly taken the randomized study drug treatment 3) have at least three of the four post-dose PK measurements btw 2 and 10 min post-dose available and 4) have a minimum of twelve of the fifteen post-dose PK measurements for the entire 6 hour post-dose PK sampling period.||pg*min/mL||Standard Deviation|Mean
825357|NCT01188577|Primary|Peak Concentration (Cmax) of Total Epinephrine From Time Zero to 6 Hours Post-dose|Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 2, 5, 7.5, 10, 12.5, 15, 20, 25, 30, 45, 60, 90, 120, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Peak (maximum) concentration (Cmax) is the highest concentration of epinephrine measured in plasma during the treatment period.|Pre-dose to 6 hours post-dose|Patients who: 1) have taken the valid pre-dose baseline PK sample 2) have correctly taken the randomized study drug treatment 3) have at least three of the four post-dose PK measurements btw 2 and 10 min post-dose available and 4) have a minimum of twelve of the fifteen post-dose PK measurements for the entire 6 hour post-dose PK sampling period.||pg/mL||Standard Deviation|Mean
825358|NCT01188577|Primary|Baseline Concentration (C0) of Total Epinephrine|Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at Baseline (prior to dosing) in each treatment period following a specified washout period (3-14 days), and were analyzed using an established analysis method. Baseline concentration (C0) is the concentration of epinephrine measured in the plasma at this time point.|0 to 30 minutes prior to dosing|Patients who: 1) have taken the valid pre-dose baseline PK sample 2) have correctly taken the randomized study drug treatment 3) have at least three of the four post-dose PK measurement btwn 2 and 10 min post-dose available and 4) have a minimum of twelve of the fifteen post-dose PK measurements for the entire 6 hour post-dose PK sampling period.||pg/mL||Standard Deviation|Mean
825359|NCT01190254|Secondary|Change From Baseline in PQ-LES-Q Overall Score (i.e., Item 15) at Day 56|PQ-LES-Q is a questionnaire to assess quality of life enjoyment and satisfaction in children and adolescents. The participant is asked to rate 15 items reflecting quality of life with respect to the previous week on a scale of 1=very poor to 5=very good. Items 1-14 assess specific areas (e.g., your health, your mood or feelings); Item 15 is a global assessment of overall quality of life. The Item 15 result is defined to be the PQ-LES-Q overall score, and ranged from 1 to 5 with a higher score indicating better quality of life. The reported measure is the change from baseline at Day 56; improvement in quality of life is represented by positive values. This analysis used an LOCF approach; if no Day 56 value was available for a participant, the last available assessment prior to the Day 56 assessment was used.|Baseline and Day 56|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS); also, to be included a baseline and at least 1 post-baseline on-treatment value of the PQ-LES-Q overall score score must be available for a participant.||score on a scale||Standard Deviation|Mean
825360|NCT01190254|Secondary|Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Total Score at Day 56|PQ-LES-Q is a questionnaire to assess quality of life enjoyment and satisfaction in children and adolescents. The participant is asked to rate 15 items reflecting quality of life with respect to the previous week on a scale of 1=very poor to 5=very good. Items 1-14 assess specific areas (e.g., your health, your mood or feelings); Item 15 is a global assessment of overall quality of life. The PQ-LES-Q total score for each participant was calculated as the sum of the rating assigned to each of the first 14 items, and ranged from 14 to 70 with a higher score indicating better quality of life. The reported measure is the change from baseline at Day 56; improvement in quality of life is represented by positive values. This analysis used a last-observation-carried-forward (LOCF) approach; if no Day 56 value was available for a participant, the last available assessment prior to the Day 56 assessment was used.|Baseline and Day 56|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS); also, to be included a baseline and at least 1 post-baseline on-treatment value of the PQ-LES-Q total score must be available for a participant.||score on a scale||Standard Deviation|Mean
825361|NCT01190254|Secondary|Change From Baseline in Children’s Global Assessment Scale (CGAS) Score at Day 56|CGAS is a 100-point scale measuring psychological, social, and school functioning in children aged 6-17. Minimum scores ranged from 1-10, representing the need for constant supervision (worse result) to maximum scores of 91-100, representing superior functioning (better result). The reported measure is the change from baseline at Day 56; improvement in functioning is represented by positive values.|Baseline and Day 56|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 56 value of the CGAS score must be available for a participant.||score on a scale||Standard Deviation|Mean
825362|NCT01190254|Secondary|Kaplan-Meier Estimate of Cumulative Percentage of Participants With CGI-I Response at End of Study|CGI-I response was defined as the occurrence of a CGI-I score of 1 (very much improved) or 2 (much improved). CGI-I is a 7-point scale for assessing the global improvement of the participant’s illness relative to baseline, with ratings from 1=very much improved to 7=very much worse. The Kaplan-Meier estimate reports the cumulative percentage of participants with CGI-I response from first drug intake up to approximately Day 58.|Baseline up to approximately Day 58|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS).||cumulative % of participants w/ Response|||Number
825363|NCT01190254|Secondary|CGI-I Responders|A CGI-I responder was defined as a participant who had a CGI-I score of 1 (very much improved) or 2 (much improved) at the last available assessment of the study for that participant (i.e., endpoint). CGI-I is a 7-point scale for assessing the global improvement of the participant’s illness relative to baseline, with ratings from 1=very much improved to 7=very much worse.|Baseline up to Day 56|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS).||participants|||Number
825364|NCT01190254|Secondary|Clinical Global Impression of Improvement (CGI-I) Score at Day 56|CGI-I is a 7-point scale for assessing the global improvement of the participant’s illness relative to baseline, with ratings from 1=very much improved to 7=very much worse.|Baseline and Day 56|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS); also, to be included an on-treatment Day 56 value of the CGI-I score must be available for a participant.||score on a scale||Standard Deviation|Mean
825365|NCT01190254|Secondary|Kaplan-Meier Estimate of Cumulative Percentage of Participants With Total PANSS 30% Response at End of Study|A total PANSS 30% response was defined as a reduction from baseline of at least 30% in the PANSS Total score. The PANSS is a 30-item clinician-rated instrument for assessing the symptoms of schizophrenia. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The Total score is the sum of the ratings for the individual items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. The Kaplan-Meier estimate reports the cumulative percentage of participants with total PANSS 30% response from first drug intake up to approximately Day 59.|Baseline up to approximately Day 59|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS).||cumulative % of participants w/ Response|||Number
825366|NCT01190254|Secondary|Total PANSS 30% Responders|A Total PANSS 30% responder was defined as a participant who had a reduction from baseline of at least 30% in the PANSS Total score at the last available assessment of the study for that participant (i.e., endpoint). The PANSS is a 30-item clinician-rated instrument for assessing the symptoms of schizophrenia. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The Total score is the sum of the ratings for the individual items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms.|Baseline up to Day 56|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS).||participants|||Number
825367|NCT01190254|Secondary|Change From Baseline in PANSS Marder Anxiety/Depression Factor Score at Day 56|This measure reports results for the 4 items of the Marder anxiety/depression factor of the PANSS, which is a 30-item clinician-rated instrument used to assess the symptoms of schizophrenia. Marder factors are a modified grouping of the 30 PANSS items. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS Marder anxiety/depression factor score for each participant was calculated as the sum of the rating assigned to each of the 4 applicable Marder factor items, and ranged from 4 to 28 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values.|Baseline and Day 56|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 56 value of the PANSS Marder anxiety/depression factor score must be available for a participant.||score on a scale||Standard Deviation|Mean
825406|NCT01190566|Secondary|Rate Constant of the Escape of the Contrast Agent From the Extracellular Extravascular Space Into the Plasma Compartment (Kep)||Baseline, post-1st chemotherapy|||min-1||Standard Deviation|Mean
825368|NCT01190254|Secondary|Change From Baseline in PANSS Marder Hostility/Excitement Factor Score at Day 56|This measure reports results for the 4 items of the Marder hostility/excitement factor of the PANSS, which is a 30-item clinician-rated instrument used to assess the symptoms of schizophrenia. Marder factors are a modified grouping of the 30 PANSS items. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS Marder hostility/excitement factor score for each participant was calculated as the sum of the rating assigned to each of the 4 applicable Marder factor items, and ranged from 4 to 28 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values.|Baseline and Day 56|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 56 value of the PANSS Marder hostility/excitement factor score must be available for a participant.||score on a scale||Standard Deviation|Mean
825369|NCT01190254|Secondary|Change From Baseline in PANSS Marder Disorganized Thoughts Factor Score at Day 56|This measure reports results for the 7 items of the Marder disorganized thoughts factor of the PANSS, which is a 30-item clinician-rated instrument used to assess the symptoms of schizophrenia. Marder factors are a modified grouping of the 30 PANSS items. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS Marder disorganized thoughts factor score for each participant was calculated as the sum of the rating assigned to each of the 7 applicable Marder factor items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values.|Baseline and Day 56|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 56 value of the PANSS Marder disorganized thoughts factor score must be available for a participant.||score on a scale||Standard Deviation|Mean
825370|NCT01190254|Secondary|Change From Baseline in PANSS Marder Negative Symptoms Factor Score at Day 56|This measure reports results for the 7 items of the Marder negative symptoms factor of the PANSS, which is a 30-item clinician-rated instrument used to assess the symptoms of schizophrenia. Marder factors are a modified grouping of the 30 PANSS items. Negative symptoms represent a diminution or loss of normal functions (e.g., emotional withdrawal). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS Marder negative symptoms factor score for each participant was calculated as the sum of the rating assigned to each of the 7 applicable Marder factor items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values.|Baseline and Day 56|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 56 value of the PANSS Marder negative symptoms factor score must be available for a participant.||score on a scale||Standard Deviation|Mean
825371|NCT01190254|Secondary|Change From Baseline in PANSS Marder Positive Symptoms Factor Score at Day 56|This measure reports results for the 8 items of the Marder positive symptoms factor of the PANSS, which is a 30-item clinician-rated instrument used to assess the symptoms of schizophrenia. Marder factors are a modified grouping of the 30 PANSS items (Marder et al. J Clin Psychiatry 1997;58(12):538-46). Positive symptoms refer to an excess or distortion of normal mental status (e.g., delusions). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS Marder positive symptoms factor score for each participant was calculated as the sum of the rating assigned to each of the 8 applicable Marder factor items, and ranged from 8 to 56 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values.|Baseline and Day 56|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 56 value of the PANSS Marder positive symptoms factor score must be available for a participant.||score on a scale||Standard Deviation|Mean
825372|NCT01190254|Secondary|Change From Baseline in PANSS General Psychopathology Subscale Score at Day 56|This measure reports results for the 16 items of the general psychopathology subscale of the PANSS, which is a 30-item clinician-rated instrument used to assess the symptoms of schizophrenia. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS general psychopathology subscale score for each participant was calculated as the sum of the rating assigned to each of the 16 subscale items, and ranged from 16 to 112 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values.|Baseline and Day 56|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 56 value of the PANSS general psychopathology subscale score must be available for a participant.||score on a scale||Standard Deviation|Mean
825373|NCT01190254|Secondary|Change From Baseline in PANSS Positive and Negative Subscale Scores Combined at Day 56|This measure reports results for the combined positive subscale (7 items) and negative subscale (7 items) of the PANSS, which is a 30-item clinician-rated instrument used to assess the symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal mental status (e.g., delusions). Negative symptoms represent a diminution or loss of normal functions (e.g., emotional withdrawal). For each of the total 14 items in the combined positive and negative subscales, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS positive and negative subscale scores combined for each participant was calculated as the sum of the rating assigned to each of the 14 combined subscale items, and ranged from 14 to 98 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values.|Baseline and Day 56|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 56 value of the PANSS positive/negative subscale scores combined must be available for a participant.||score on a scale||Standard Deviation|Mean
825374|NCT01190254|Secondary|Change From Baseline in PANSS Negative Subscale Score at Day 56|This measure reports results for the 7 items of the negative subscale of the PANSS, which is a 30-item clinician-rated instrument used to assess the symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions (e.g., emotional withdrawal). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS negative subscale score for each participant was calculated as the sum of the rating assigned to each of the 7 subscale items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values.|Baseline and Day 56|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 56 value of the PANSS negative subscale score must be available for a participant.||score on a scale||Standard Deviation|Mean
825375|NCT01190254|Secondary|Change From Baseline in PANSS Positive Subscale Score at Day 56|This measure reports results for the 7 items of the positive subscale of the PANSS, which is a 30-item clinician-rated instrument used to assess the symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal mental status (e.g., delusions). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS positive subscale score for each participant was calculated as the sum of the rating assigned to each of the 7 subscale items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values.|Baseline and Day 56|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 56 value of the PANSS positive subscale score must be available for a participant.||score on a scale||Standard Deviation|Mean
825376|NCT01190254|Secondary|Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Day 56|Change from baseline in CGI-S score at Day 56 is the Key Secondary Outcome Measure. CGI-S is a 7-point scale for assessing the global severity of the participant’s illness, with ratings from 1=normal, not ill to 7=very severely ill. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values.|Baseline and Day 56|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 56 value of the CGI-S score must be available for a participant.||score on a scale||Standard Deviation|Mean
825377|NCT01190254|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 56|The PANSS is a 30-item clinician-rated instrument for assessing the symptoms of schizophrenia. It consists of 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items). Positive symptoms refer to an excess or distortion of normal mental status (e.g., delusions). Negative symptoms represent a diminution or loss of normal functions (e.g., emotional withdrawal). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score for each participant was calculated as the sum of the rating assigned to each of the 30 PANSS items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values.|Baseline and Day 56|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy Full Analysis Set [FAS]); also, to be included an on-treatment Day 56 value of PANSS Total Score must be available for a participant.||score on a scale||Standard Deviation|Mean
825378|NCT01190267|Primary|Number of Participants Who Discontinued Study Drug During Extension Study Due to an AE|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|Up to 26 weeks|All participants who received at least one dose of extension study medication||participants|||Number
825379|NCT01190267|Primary|Number of Participants With a Treatment-Emergent Adverse Event (AE) During Extension Study|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An AE was defined as a “treatment-emergent” AE if it was not present at the extension study baseline, or if it was present at the extension study baseline but worsened in severity compared to baseline during the extension study treatment period.|Up to 30 weeks|All participants who received at least one dose of extension study medication||participants|||Number
825380|NCT01190306|Primary|Change in Corneal Curvature.||6 Months|The CXL-001 study was completed but data analysis was not done. Prior to data analysis, the sponsor, Topcon, decided to terminate the study for administrative reasons only, and not as a result of any safety issues or concerns relating to the study.|||||
825381|NCT01190306|Primary|Changes in Corneal Curvature||6MO||||||
825382|NCT01190436|Secondary|Number of Participants With Adverse Events (AEs)|An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship.|Baseline up to Week 12|ITT population included all participants who received at least 1 dose of study drug.||participants|||Number
825383|NCT01190436|Secondary|Mean Change From Baseline in Total Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL) Cholesterol and Triglyceride Level at Week 12|The change in total cholesterol, LDL cholesterol, HDL cholesterol and triglyceride level at Week 12 was calculated as total cholesterol, LDL cholesterol, HDL cholesterol and triglyceride level at Week 12 minus total cholesterol, LDL cholesterol, HDL cholesterol and triglyceride level at baseline, respectively.|Baseline, Week 12|ITT population included all participants who received at least 1 dose of study drug.||mg/dL||Standard Deviation|Mean
825385|NCT01190436|Secondary|Mean Change From Baseline in Fasting Blood Sugar (FBS) Level at Week 12|The change in FBS level at Week 12 was calculated as FBS level at Week 12 minus FBS level at baseline.|Baseline, Week 12|ITT population included all participants who received at least 1 dose of study drug.||mg/dL||Standard Deviation|Mean
825386|NCT01190436|Secondary|Percentage of Participants With Increased Fasting Blood Sugar (FBS) at Week 12|Percentage of participants with increased FBS (greater than 16 milligram per deciliter [mg/dL] from baseline) at Week 12 was reported.|Week 12|ITT population included all participants who received at least 1 dose of study drug.||percentage of participants|||Number
825387|NCT01190436|Primary|Mean Change From Baseline in Heart Rate at Week 12|The change in heart rate at Week 12 was calculated as the heart rate at Week 12 minus heart rate at baseline.|Baseline, Week 12|ITT population included all participants who received at least 1 dose of study drug.||beats per minute (bpm)||Standard Deviation|Mean
825388|NCT01190436|Primary|Percentage of Participants With Response to Study Drug|Response to study drug was defined as lowering of systolic BP by at least 10 mmHg from baseline.|Week 12|ITT population included all participants who received at least 1 dose of study drug.||percentage of participants|||Number
825389|NCT01190436|Primary|Percentage of Participants With Controlled BP|Controlled BP was defined as BP less than 130/80 mmHg.|Week 12|ITT population included all participants who received at least 1 dose of study drug.||percentage of participants|||Number
825390|NCT01190436|Primary|Mean Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Week 12|The change in diastolic and systolic BP at Week 12 was calculated as diastolic and systolic BP at Week 12 minus diastolic and systolic BP at baseline, respectively.|Baseline, Week 12|Intent-to-treat (ITT) population included all participants who received at least 1 dose of study drug.||mmHg||Standard Deviation|Mean
825391|NCT01190436|Secondary|Mean Change From Baseline in HbA1c at Week 12|HbA1c represents the percentage of glycosylated hemoglobin. The change in HbA1c at Week 12 was calculated as HbA1c at Week 12 minus HbA1c at baseline.|Baseline, Week 12|ITT population included all participants who received at least 1 dose of study drug.||Percent HbA1c||Standard Deviation|Mean
825392|NCT01190436|Secondary|Percentage of Participants With Increased Glycosylated Hemoglobin (HbA1c) at Week 12|HbA1c represents the percentage of glycosylated hemoglobin. Percentage of participants with increased HbA1c (greater than 0.5% from baseline) at Week 12 was reported.|Week 12|ITT population included all participants who received at least 1 dose of study drug.||percentage of participants|||Number
825393|NCT01190514|Secondary|Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Time of the Last Quantifiable Concentration (AUClast)||Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose|PK population; N=number of participants contributing to the mean.||ng*hr/mL||Standard Deviation|Mean
825394|NCT01190514|Secondary|Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf)|Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose|PK population; N=number of participants contributing to the mean.||ng*hr/mL||Standard Deviation|Mean
825395|NCT01190514|Secondary|Terminal Elimination Half-life (t 1/2)|Terminal elimination (plasma decay) half-life is the time measured for the plasma concentration to decrease by one half.|Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose|PK population; N=number of participants contributing to the median.||hours||Standard Deviation|Mean
825396|NCT01190514|Primary|Maximum Plasma Concentration (Cmax)|Cmax measured as nanograms divided by milliliters (ng/mL).|Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose|PK population; N=number of participants contributing to the mean.||ng/mL||Standard Deviation|Mean
825397|NCT01190514|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose|PK population; N=number of participants contributing to the median.||hours||Full Range|Median
825398|NCT01190514|Primary|Area Under the Plasma Concentration-time Profile From Time 0 to 48 Hours (AUC48)|Area under the plasma concentration versus time curve from time zero (pre-dose) to 48 hours post dose; measured as nanograms multiplied by hours divided by milliliters (ng*hr/mL).|Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose|Pharmacokinetic parameter analysis (PK) population: all participants randomized and treated and had at least 1 of the PK parameters of primary interest in at least 1 treatment period. N=number of participants contributing to the mean.||ng*hr/mL||Standard Deviation|Mean
825399|NCT01190527|Secondary|The Number of Participants That Experience Lung Toxicity and Esophagitis|The number of participants that experience RT (radiation therapy) induced lung toxicity, and grade 2 or greater (symptomatic) esophagitis, will be recorded.|2 years|||participants|||Number
825400|NCT01190527|Secondary|Percentage of Patients Alive at 2 Years|Overall survival of all patients will be estimated|2 years|||percentage of patients||95% Confidence Interval|Number
825401|NCT01190527|Secondary|Number of Patients That Were Able to Receive Dose Escalation|The number of patients for which dose escalation was possible will be reported.|2 Years|||participants|||Number
825402|NCT01190527|Primary|2 Year Rate of Overall Local-Regional Tumor Control Using FGD-PET-CT During Radiation Therapy(RT)|Use FGD-PET-CT based adaptive radiation to deliver a higher total dose to the active tumor to determine if it will improve the local-regional tumor control and progression-free survival in patients, without increasing the normal tissue complication probability (NTCP) of the lung.|2 years|||percentage of patients||95% Confidence Interval|Number
825403|NCT01190566|Secondary|Standardized Uptake Value on 18F-fluoro-deoxy-glucose Positron Emission Tomography||Baseline, post-1st chemotherapy|||unitless||Standard Deviation|Mean
825404|NCT01190566|Secondary|Total Choline Amount of the Tumor Measured on Single Voxel 1H-magnetic Resonance Spectroscopy|Single voxel 1H-magnetic resonance spectroscopy quantifies the amount of total choline-containing compounds of a tumor, which indicates cellular proliferation and malignant transformation.|Baseline, post-1st chemotherapy|Of the 48 participants, 13 participants did not undergo magnetic resonance spectroscopy examinations due to workflow problem. We included the available data from 35 participants.||unitless||Standard Deviation|Mean
825405|NCT01190566|Secondary|Extracellular Extravascular Space Per Unit Volume of Tissue (Ve)||Baseline, post-1st chemotherapy|||unitless||Standard Deviation|Mean
825408|NCT01190566|Secondary|Proportions of Voxels Within a Tumor With Increased or Decreased Signal Intensity (Parametric Response Map Signal Intensity; PRMSI)|Parametric response map analysis using a software calculates the interval change of signal intensity based on a voxel-to-voxel comparison between measurements at baseline and after the first cycle of chemotherapy. PRMSI+ indicates proportions of voxels within a tumor with increased signal intensity. PRMSI- indicates proportions of voxels within a tumor with decreased signal intensity. PRMSI0 indicates proportions of voxels within a tumor with unchanged signal intensity.|Baseline, post-1st chemotherapy|||% of voxels||Standard Deviation|Mean
825409|NCT01190566|Secondary|Tumor Volume|Tumor volume measured on 3-dimensional magnetic resonance imaging|Baseline, post-1st chemotherapy|||cm3||Standard Deviation|Mean
825410|NCT01190566|Secondary|Tumor Size|Maximal tumor diameter measured on magnetic resonance imaging|baseline, completion of 1st cycle of chemotherapy|||cm||Standard Deviation|Mean
825411|NCT01190566|Primary|Patholocial Response to Chemotherapy|Pathological complete response (pCR) or non-pCR|Post-operation|||participants|||Number
825412|NCT01190813|Secondary|Mean Fellow Eye Visual Acuity Change From Baseline at 26 Weeks|Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.|26 weeks after enrollment|||letters||Standard Deviation|Mean
825413|NCT01190813|Secondary|Distribution of Fellow Eye Visual Acuity Change From Baseline at 26 Weeks|Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.|26 weeks after enrollment|All participants continued in the study regardless of whether they continued with study medication after the 18-week visit; 49 participants in the levodopa group and 24 participants in the placebo group continued study medication at the 18-week visit.||participants|||Number
825414|NCT01190813|Secondary|Mean Fellow Eye Visual Acuity at 26 Weeks|Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.|26 weeks after enrollment|All participants continued in the study regardless of whether they continued with study medication after the 18-week visit; 49 participants in the levodopa group and 24 participants in the placebo group continued study medication at the 18-week visit.||letters||Standard Deviation|Mean
825415|NCT01190813|Secondary|Distribution of Fellow Eye Visual Acuity at 26 Weeks|Similar to the analysis for the amblyopic eye, the fellow eye visual acuity will be evaluated to determine if study treatment had an adverse effect on the occluded eye. The analysis will be a treatment group comparison of the mean fellow eye visual acuity at 26 weeks after enrollment, adjusted for baseline acuity.|26 weeks after enrollment|All participants continued in the study regardless of whether they continued with study medication after the 18-week visit; 49 participants in the levodopa group and 24 participants in the placebo group continued study medication at the 18-week visit.||participants|||Number
825416|NCT01190813|Secondary|Mean Systemic Adverse Events||Enrollment through 26 weeks|||events||Standard Deviation|Mean
825417|NCT01190813|Secondary|Mean Parent Symptom Survey Score at 26 Weeks|A treatment group comparison of symptom survey scores at the 26 week visit. The average of the overall item responses will be calculated and compared by treatment group with a t-test for difference in means. A higher number reflects a more negative response (5=always, 4=often, 3=sometimes, 2=rarely, 1=never).|26 weeks after enrollment|||units on a scale||Standard Deviation|Mean
825418|NCT01190813|Secondary|Mean Parent Symptom Survey Score at 18 Weeks|A treatment group comparison of symptom survey scores at the primary outcome (18 week) visit. The average of the overall item responses will be calculated and compared by treatment group with a t-test for difference in means. A higher number reflects a more negative response (5=always, 4=often, 3=sometimes, 2=rarely, 1=never).|18 weeks after enrollment|||units on a scale||Standard Deviation|Mean
825419|NCT01190813|Secondary|Mean Parent Symptom Survey Score at 16 Weeks|A treatment group comparison of symptom survey scores at the 16 week visit. The average of the overall item responses will be calculated and compared by treatment group with a t-test for difference in means. A higher number reflects a more negative response (5=always, 4=often, 3=sometimes, 2=rarely, 1=never).|16 weeks after enrollment|||units on a scale||Standard Deviation|Mean
825420|NCT01190813|Secondary|Mean Parent Symptom Survey Score at 10 Weeks|A treatment group comparison of symptom survey scores at the 10 week visit. The average of the overall item responses will be calculated and compared by treatment group with a t-test for difference in means. A higher number reflects a more negative response (5=always, 4=often, 3=sometimes, 2=rarely, 1=never).|10 weeks after enrollment|||units on a scale||Standard Deviation|Mean
825421|NCT01190813|Secondary|Mean Parent Symptom Survey Score at 4 Weeks|A treatment group comparison of symptom survey scores at the 4 week visit. The average of the overall item responses will be calculated and compared by treatment group with a t-test for difference in means. A higher number reflects a more negative response (5=always, 4=often, 3=sometimes, 2=rarely, 1=never).|4 weeks after enrollment|||units on a scale||Standard Deviation|Mean
825422|NCT01190813|Secondary|Mean Parent Symptom Survey Score at Enrollment|A treatment group comparison of symptom survey scores at enrollment. The average of the overall item responses will be calculated and compared by treatment group with a t-test for difference in means. A higher number reflects a more negative response (5=always, 4=often, 3=sometimes, 2=rarely, 1=never).|At enrollment|||units on a scale||Standard Deviation|Mean
825423|NCT01190813|Secondary|Mean Child Symptom Survey Score at 26 Weeks|A treatment group comparison of symptom survey scores at the 26 week visit. The average of the overall item responses will be calculated and compared by treatment group with a t-test for difference in means. A higher number reflects a more negative response (5=always, 4=often, 3=sometimes, 2=rarely, 1=never).|26 weeks after enrollment|||units on a scale||Standard Deviation|Mean
825424|NCT01190813|Secondary|Mean Child Symptom Survey Score at 18 Weeks|A treatment group comparison of symptom survey scores at the primary outcome (18 week) visit. The average of the overall item responses will be calculated and compared by treatment group with a t-test for difference in means. A higher number reflects a more negative response (5=always, 4=often, 3=sometimes, 2=rarely, 1=never).|18 weeks after enrollment|||units on a scale||Standard Deviation|Mean
825425|NCT01190813|Secondary|Mean Child Symptom Survey Score at 16 Weeks|A treatment group comparison of symptom survey scores at the 16 week visit. The average of the overall item responses will be calculated and compared by treatment group with a t-test for difference in means. A higher number reflects a more negative response (5=always, 4=often, 3=sometimes, 2=rarely, 1=never).|16 weeks after enrollment|||units on a scale||Standard Deviation|Mean
825426|NCT01190813|Secondary|Mean Child Symptom Survey Score at 10 Weeks|A treatment group comparison of symptom survey scores at the 10 week visit. The average of the overall item responses will be calculated and compared by treatment group with a t-test for difference in means. A higher number reflects a more negative response (5=always, 4=often, 3=sometimes, 2=rarely, 1=never).|10 weeks after enrollment|||units on a scale||Standard Deviation|Mean
825427|NCT01190813|Secondary|Mean Child Symptom Survey Score at 4 Weeks|A treatment group comparison of symptom survey scores at the 4 week visit. The average of the overall item responses will be calculated and compared by treatment group with a t-test for difference in means. A higher number reflects a more negative response (5=always, 4=often, 3=sometimes, 2=rarely, 1=never).|4 weeks after enrollment|||units on a scale||Standard Deviation|Mean
825428|NCT01190813|Secondary|Mean Child Symptom Survey Score at Enrollment|A treatment group comparison of symptom survey scores at enrollment. The average of the overall item responses will be calculated and compared by treatment group with a t-test for difference in means. A higher number reflects a more negative response (5=always, 4=often, 3=sometimes, 2=rarely, 1=never).|At enrollment|||units on a scale||Standard Deviation|Mean
825429|NCT01190813|Secondary|Mean Fellow Eye Visual Acuity Change From Baseline at 18 Weeks|Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.|18 weeks after enrollment|||letters||Standard Deviation|Mean
825430|NCT01190813|Primary|Mean Amblyopic Eye Visual Acuity Change From Baseline|"The primary outcome is the amblyopic eye visual acuity letter score measured at the 18-week primary outcome visit following a rapid taper of study medicine beginning at week 16. The primary analytic approach will be a treatment group comparison of the mean amblyopic eye visual acuity adjusted for baseline acuity.
Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line."|18 weeks after enrollment|The ITT principle was followed. For subjects with no visit in the +/- 1 wk window for the 18-wk visit, data from a visit 14-27 wks after randomization were used, if available. Multiple imputation by the Monte Carlo Markov Chain method was used for missing 18-wk VA outcomes based on tx group, baseline VA, & VA scores from completed follow-up visits.||letters||Standard Deviation|Mean
825431|NCT01190813|Secondary|Distribution of Fellow Eye Visual Acuity Change From Baseline at 18 Weeks|Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.|18 weeks after enrollment|||participants|||Number
825432|NCT01190813|Secondary|Mean Fellow Eye Visual Acuity at 18 Weeks|Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.|18 weeks after enrollment|||letters||Standard Deviation|Mean
825433|NCT01190813|Secondary|Distribution of Fellow Eye Visual Acuity at 18 Weeks|Similar to the analysis for the amblyopic eye, the fellow eye visual acuity will be evaluated to determine if study treatment had an adverse effect on the occluded eye. The analysis will be a treatment group comparison of the mean fellow eye visual acuity at 18 weeks after enrollment, adjusted for baseline acuity.|18 weeks after enrollment|||participants|||Number
825434|NCT01190813|Secondary|Mean Change in Amblyopic Eye Visual Acuity From Baseline at 26 Weeks|A treatment group comparison of the mean amblyopic eye visual acuity at 26 weeks after enrollment, adjusted for baseline acuity. Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.|26 weeks after enrollment|||letters||Standard Deviation|Mean
825435|NCT01190813|Secondary|Distribution of Amblyopic Eye Visual Acuity Change From Baseline at 26 Weeks|Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.|26 weeks after enrollment|||participants|||Number
825436|NCT01190813|Secondary|Mean Change in Amblyopic Eye Visual Acuity From Baseline at 16 Weeks|A treatment group comparison of the mean amblyopic eye visual acuity at 16 weeks after enrollment, adjusted for baseline acuity. Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.|16 weeks after enrollment|||letters||Standard Deviation|Mean
825437|NCT01190813|Secondary|Distribution of Amblyopic Eye Visual Acuity Change From Baseline at 16 Weeks|Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.|16 weeks after enrollment|||participants|||Number
825438|NCT01190813|Secondary|Mean Change in Amblyopic Eye Visual Acuity From Baseline at 10 Weeks|A treatment group comparison of the mean amblyopic eye visual acuity at 10 weeks after enrollment, adjusted for baseline acuity. Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.|10 weeks after enrollment|||letters||Standard Deviation|Mean
825439|NCT01190813|Secondary|Distribution of Amblyopic Eye Visual Acuity Change From Baseline at 10 Weeks|Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.|10 weeks after enrollment|||participants|||Number
825440|NCT01190813|Secondary|Mean Change in Amblyopic Eye Visual Acuity From Baseline at 4 Weeks|A treatment group comparison of the mean amblyopic eye visual acuity at 4 weeks after enrollment, adjusted for baseline acuity.|4 weeks after enrollment|||letters||Standard Deviation|Mean
825441|NCT01190813|Secondary|Distribution of Amblyopic Eye Visual Acuity Change From Baseline at 4 Weeks|Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.|4 weeks after enrollment|||participants|||Number
825442|NCT01190813|Secondary|Amblyopia Resolution at 26 Weeks|Treatment group comparisons adjusted for baseline acuity scores using logistic regression of the proportion of subjects with 20/25 or better visual acuity.|26 weeks after enrollment|||participants|||Number
825443|NCT01190813|Secondary|Amblyopia Resolution at 18 Weeks|Treatment group comparisons adjusted for baseline acuity scores using logistic regression of the proportion of subjects with 20/25 or better visual acuity.|18 weeks after enrollment|||participants|||Number
825444|NCT01190813|Secondary|Amblyopia Resolution at 16 Weeks|Treatment group comparisons adjusted for baseline acuity scores using logistic regression of the proportion of subjects with 20/25 or better visual acuity.|16 weeks after enrollment|||participants|||Number
825445|NCT01190813|Secondary|Amblyopia Resolution at 10 Weeks|Treatment group comparisons adjusted for baseline acuity scores using logistic regression of the proportion of subjects with 20/25 or better visual acuity.|10 weeks after enrollment|||participants|||Number
825446|NCT01190813|Secondary|Amblyopia Resolutionat 4 Weeks|Treatment group comparisons adjusted for baseline acuity scores using logistic regression of the proportion of subjects with 20/25 or better visual acuity.|4 weeks after enrollment|||participants|||Number
825447|NCT01190813|Secondary|Amblyopic Eye Visual Acuity Improvement Treatment Group Comparison at 26 Weeks|Treatment group comparisons adjusted for baseline acuity scores using logistic regression of the proportion of subjects who have improved from baseline by 10 or more letters.|26 weeks after enrollment|||participants|||Number
825448|NCT01190813|Secondary|Amblyopic Eye Visual Acuity Improvement Treatment Group Comparison at 16 Weeks|Treatment group comparisons of the proportion of subjects who have improved from baseline by 10 or more letters.|16 weeks after enrollment|||participants|||Number
825449|NCT01190813|Secondary|Amblyopic Eye Visual Acuity Improvement Treatment Group Comparison at 10 Weeks|Treatment group comparisons of the proportion of subjects who have improved from baseline by 10 or more letters.|10 weeks after enrollment|||participants|||Number
825450|NCT01190813|Secondary|Amblyopic Eye Visual Acuity Improvement Treatment Group Comparison at 4 Weeks|Treatment group comparisons adjusted for baseline acuity scores using logistic regression of the proportion of subjects who have improved from baseline by 10 or more letters.|4 weeks after enrollment|||participants|||Number
825451|NCT01190813|Secondary|Mean Amblyopic Eye Visual Acuity at 18 Weeks|Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.|18 weeks after enrollment|||letters||Standard Deviation|Mean
825452|NCT01190813|Secondary|Distribution of Amblyopic Eye Visual Acuity at 18 Weeks||18 weeks after enrollment|||participants|||Number
825453|NCT01190813|Secondary|Amblyopic Eye Visual Acuity Improvement Treatment Group Comparison at 18 Weeks|Treatment group comparisons of the proportion of subjects who have improved from baseline by 10 or more letters.|18 weeks after enrollment|The analysis followed the intent-to-treat principle. For missing primary outcome visits (±1 wk), data from a visit 14-27 wks after randomization were used, if available.Multiple imputation(Monte Carlo Markov Chain method) was used for missing 18-wk VA outcomes based on treatment group, baseline VA, and VA scores from completed follow-up visits||participants|||Number
825454|NCT01190813|Primary|Distribution of Amblyopic Eye Visual Acuity Change From Baseline|"The primary outcome is the amblyopic eye visual acuity letter score measured at the 18-week primary outcome visit following a rapid taper of study medicine beginning at week 16. The primary analytic approach will be a treatment group comparison of the mean amblyopic eye visual acuity adjusted for baseline acuity.
Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line."|18 weeks after enrollment|The ITT principle was followed. For subjects with no visit in the +/- 1 wk window for the 18-wk visit, data from a visit 14-27 wks after randomization were used, if available. Multiple imputation by the Monte Carlo Markov Chain method was used for missing 18-wk VA outcomes based on tx group, baseline VA, & VA scores from completed follow-up visits.||participants|||Number
825455|NCT01190839|Secondary|Percentage of Participants With Clinical Recurrence (CR) of Crohn's Disease (CD) Prior to or at Week 104|CR criteria:1) A >=70-point increase from baseline in CDAI score [in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities];2)A CDAI score >=200;3)Evidence of endoscopic recurrence [ileal Rutgeerts score of >=i2 at anastomotic site or its equivalent elsewhere in GI tract] and 4)A negative stool test for C. difficile toxin (if, in the opinion of the investigator, the participant's symptoms are predominantly diarrheal); or at least 1 of followings:1) developing a new draining external fistula;2)re-opening and draining of a previously existing external fistula;3)developing a new internal fistula;4)developing a new perianal abscess or 5)developing a new intra-abdominal abscess more than 3 months after date of index surgery. In addition, participants who had a treatment failure [initiated a prohibited CD medication, had prohibited use of CD medication, or had surgery for CD]before or at Week 104 were considered to have clinical recurrence.|Baseline up to Week 104|Analysis population included all the participants who were randomly assigned to receive 1 of the study treatments.||percentage of participants|||Number
825456|NCT01190839|Secondary|Percentage of Participants With Endoscopic Recurrence of CD Prior to or at Week 76|Endoscopic recurrence is defined as an ileal Rutgeert's score of >= i2 either at the anastomotic site or elsewhere in the gastrointestinal tract. In addition, participants who had a treatment failure (initiated a prohibited CD medication, had a prohibited use of a CD medication, or had a surgery for CD) prior to Week 76, and who developed a new draining external fistula or re-opening and draining of a previously existing external fistula or developed a new internal fistula, new perianal abscess or new intra-abdominal abscess more than 3 months after the date of the index surgery were considered to have had endoscopic recurrence prior to or at Week 76.|Baseline up to Week 76|Analysis population included all the participants who were randomly assigned one of the treatment.||percentage of participants|||Number
831484|NCT01246076|Secondary|Overall Survival Rate|-Overall survival rate is the percentage of participants who were alive 6 months after end of treatment.|6 months after end of treatment (up to 82 weeks from start of treatment)|||percentage of participants|||Number
825457|NCT01190839|Primary|Percentage of Participants With Clinical Recurrence (CR) of Crohn's Disease (CD) Prior to or at Week 76|CR criteria:1) A >=70-point increase from baseline in CDAI score [in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities];2)A CDAI score >=200;3)Evidence of endoscopic recurrence [ileal Rutgeerts score of >=i2 at anastomotic site or its equivalent elsewhere in GI tract] and 4)A negative stool test for C. difficile toxin (if, in the opinion of the investigator, the participant's symptoms are predominantly diarrheal); or at least 1 of followings:1) developing a new draining external fistula;2)re-opening and draining of a previously existing external fistula;3)developing a new internal fistula;4)developing a new perianal abscess or 5)developing a new intra-abdominal abscess more than 3 months after date of index surgery. In addition, participants who had a treatment failure [initiated a prohibited CD medication, had prohibited use of CD medication, or had surgery for CD] before or at Week 76 were considered to have clinical recurrence.|Baseline up to Week 76|Analysis population included all the participants who were randomly assigned to receive 1 of the study treatments.||percentage of participants|||Number
825458|NCT01190865|Secondary|Time in Days to 50% Correct Identification (ID50) of the Implanted Male DNA 17 Loci in Female Volunteers, With Regard to Three DNA Profile Types, Including Partial DNA Profile, > 50% DNA Profile, and Full (or Complete) DNA Profile.|"The biopsy area was examined for the presence of the Y chromosome, based on the presence of a full set of Y-STR loci as well as partial sets, assayed by a commercial kit (AmpFISTRTM).
Probit analysis was utilized to determine the time in days to 50% correct identification (ID50) of the implanted male DNA 17 loci in female volunteers, with regard to three DNA profile types, including partial DNA profile, > 50% DNA profile, and full (or complete) DNA profile. The analysis was performed using SAS® PROC PROBIT"|Cohorts of 3 subjects were biopsied at weekly intervals for 8 weeks|The analysis population consisted of the 8 cohorts of 3 subjects biopsied at weekly intervals over the 8-week duration of the study. It should be note that the cohort for Week 8 (Day 57) was composed of 4 subjects||Days||95% Confidence Interval|Number
825459|NCT01190865|Primary|Identification of the Full Set of Y-chromosome Short Tandem Repeats in Each Bioopsy.|The primary efficacy variable was detection of the full set of 17 Y STR loci. If all loci amplified such that a clear identification of a donor was possible, the test result was categorized as positive. If fewer loci amplified such that identification of the donor was not possible in a forensic setting, the result was categorized as negative. Descriptive statistics are presented for this variable.|Cohorts of 3 subjects were biopsied at weekly intervals for 8 weeks|3 subjects were withdrawn; 2 for non-compliance and one at the subject's request. One subject, who was available to replace a subject assigned to a weekly cohort if the subject was unavailable, was assayed on Day 57 with the subjects assigned to the Week 8 cohort.||Participants|||Count of Participants
825460|NCT01190878|Primary|Ocular Inflammation|"Anterior Chamber Cell Grade 0 at Day 15 measured on a 0 to 4 scale: 0 is 0 cells; 1 is 1-10 cells; 2 is 11-20 cells; 3 is 21-50 cells; 4 is > 50 cells."|15 days|Intent-to-Treat (ITT) Population using Last Observation Carried Forward (LOCF) method.||participants|||Number
825461|NCT01190891|Secondary|Global Rating of Change|The GROC questionnaire is an instrument that measures overall changes in the quality of life of the subject. The use of a GROC is a common, feasible, and useful method for assessing outcome, and has been shown to be a valid measurement of change in patient status in other pain populations. A change in score of three rating points has been established as a clinically significant in the patients perception of quality of life. The GROC has 15 possible choices, with 0 being equal to no change and -1 to -7 indicating a negative change and +1 to +7 indicating a positive change.|1 year|||units on a scale||95% Confidence Interval|Mean
825462|NCT01190891|Primary|Shoulder Pain and Disability Index|The SPADI is a 100-point, 13 item self-administered questionnaire divided into two subscales (pain and disability), with higher scores indicating greater pain and disability. It is responsive to change and accurately discriminates between patients who are improving or worsening. It has high test-retest reliability and internal consistency. The minimal detectable change (MDC) is 18 and the minimally clinically important difference (MCID) is between 8-13 points. The validity and responsiveness to change of SPADI have been described in physical therapy, as well as primary and secondary care settings.|1 year|||units on a scale||95% Confidence Interval|Mean
825463|NCT01191008|Other Pre-specified|Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert|A treatment-related adverse event was any untoward medical occurrence attributed to latanoprost/timolol maleate in a participant who received latanoprost/timolol maleate. Expectedness of the adverse event was determined according to Japanese package insert. Relatedness to latanoprost/timolol maleate was assessed by the investigator.|Max 104 weeks|The safety analysis set comprised of participants who had met the inclusion criteria and had received latanoprost/timolol maleate at least once.||Participants|||Number
825464|NCT01191008|Primary|Clinical Effectiveness Rate|Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of effectiveness analysis population, was presented along with the corresponding exact 2sided 95% confidence interval. Overall effectiveness of latanoprost/timolol was determined by the investigator based on clinical symptoms and examinations. Clinical effectiveness was assessed according to the following categories: (1) effective, (2) not effective, or (3) not assessable at the end of observation period (Max 104 weeks).|Max 104 weeks|The effectiveness analysis set comprised of participants that were excluded off-label uses or blank evaluation from safety analysis set.||Percentage of participants||95% Confidence Interval|Number
825465|NCT01191008|Primary|Number of Participants WithTreatment-Related Adverse Events|A treatment-related adverse event was any untoward medical occurrence attributed to latanoprost/timolol maleate in a participant who received latanoprost/timolol maleate. Relatedness to latanoprost/timolol maleate was assessed by the investigator.|Max 104 weeks|The safety analysis set comprised of participants who had met the inclusion criteria and had received latanoprost/timolol maleate at least once.||Participants|||Number
825466|NCT01191086|Primary|Evaluate the Safety of USL255 Through the Collection of Adverse Events and Clinical Laboratory Evaluations||Open label treatment of up to 62 weeks|The intent-to-treat (ITT) population was used for all analyses. The ITT population included all subjects who received at least 1 dose of study drug in this extension study.||participants|||Number
825467|NCT01191190|Secondary|Detectable Minimal Residual Disease (MRD)|The patient who achieved a CR did not have detectable MRD in the bone marrow by four-color flow cytometry (<0.1% of cells).|2 years|||participants|||Number
825471|NCT01191190|Secondary|IwCLL-WG Defined Progressive Disease (PD)|"Responses were assessed two months after completion of therapy
Progressive Disease is defined as:
Greater than or equal to 50% increase in the products of at least two lymph nodes on two consecutive determinations two weeks apart (at least one lymph node must be ≥ 2 cm; or the appearance of a new palpable lymph node; OR
Greater than or equal to 50% increase in the size of the liver and/or spleen as determined by measurement below the respective costal margins; or appearance of palpable hepatomegaly or splenomegaly, which was not previously present; OR
Greater than or equal to 50% increase in the absolute number of circulating lymphocytes to at least 5,000μl; OR
Transformation to a more aggressive histology (i.e., Richter’s syndrome or prolymphocytic leukemia with ≥ 56% prolymphocytes);"|2 months|||participants|||Number
825472|NCT01191190|Secondary|IwCLL-WG Defined Stable Disease (SD)|"Responses were assessed two months after completion of therapy.
Subjects who do not fulfill the criteria for complete or partial response as defined above but do not exhibit progressive disease will be considered as having stable disease."|2 months|||participants|||Number
825473|NCT01191190|Secondary|IwCLL-WG Defined Partial Response (PR)|Responses were assessed two months after completion of therapy|2 months|||participants|||Number
825474|NCT01191190|Secondary|IwCLL-WG Defined Nodular Partial Response (PR)|"Responses were assessed two months after completion of therapy.
Partial Response is defined as:
Greater than or equal to 50% decrease in blood absolute lymphocyte count from pre-treatment value; AND
Greater than or equal to 50% reduction in lymphadenopathy from pre-treatment value; AND
Greater than or equal to 50% reduction in splenomegaly/hepatomegaly from pre-treatment value.
In addition, patients need to have at least ONE of the following:
Neutrophils ≥ 1,500/μl or ≥ 50% improvement from pre-treatment value; AND / OR
Platelets > 100,000/μl or 50% improvement from pre-treatment value; AND / OR
Hemoglobin > 11.0 gm/dl (non-transfused) or 50% improvement from pre-treatment value."|2 months|||participants|||Number
825475|NCT01191190|Secondary|IwCLL-WG Defined Overall Response Rate (ORR)|Responses were assessed two months after completion of therapy. Overall Response Rate (ORR) = CR + PR|2 months|||participants|||Number
825476|NCT01191190|Primary|IwCLL-WG Defined Complete Response (CR)|"Responses were assessed two months after completion of therapy.
Criteria for complete remission is assessed with: a bone marrow biopsy and repeat CT scan (abdominal, chest and pelvis if initial was abnormal) to confirm iwCLL-WG defined CR.
iwCLL-WG Complete Response is defined as:
Peripheral blood lymphocytes (evaluated by blood and differential count) below 4 x 109/L (4000/L).
Absence of lymphadenopathy (>1.5 cm)of physical exam; AND
No hepatomegaly and splenomegaly on physical exam; AND
Absence of constitutional symptoms; AND
Normal complete blood count as exhibited by neutrophils ≥ 1,500/μl, platelets > 100,000/μl, hemoglobin > 11.0g/dL (non-transfused), and lymphocyte count < 5,000/μl; AND
Bone marrow aspirate and biopsy must be normocellular for age with <30% of nucleated cells being lymphocytes. Lymphoid nodules must be absent"|2 months|||participants|||Number
825477|NCT01191242|Primary|(R)-EDDP Trough Plasma Concentration||Day 1, Day 7, Day 21|||ng/mL||Standard Deviation|Mean
825478|NCT01191242|Primary|(R)-EDDP Peak Plasma Concentration||Day 1, Day 7, Day 21|||ng/mL||Standard Deviation|Mean
825479|NCT01191242|Primary|(S)-EDDP Trough Plasma Concentration||Day 1, Day 7, Day 21|||ng/mL||Standard Deviation|Mean
825480|NCT01191242|Primary|(S)-EDDP Peak Plasma Concentration||Day 1, Day 7, Day 21|||ng/mL||Standard Deviation|Mean
825481|NCT01191242|Primary|Total EDDP Trough Plasma Concentration||Day 1, Day 7, Day 21|||ng/mL||Standard Deviation|Mean
825482|NCT01191242|Primary|Total 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidene (EDDP) Peak Plasma Concentration||Day 1, Day 7, Day 21|||ng/mL||Standard Deviation|Mean
825483|NCT01191242|Primary|(R)-Methadone Trough Plasma Concentration||Day 1, Day 7, Day 21|||ng/mL||Standard Deviation|Mean
825484|NCT01191242|Primary|(R)-Methadone Peak Plasma Concentration||Day 1, Day 7, Day 21|||ng/mL||Standard Deviation|Mean
825485|NCT01191242|Primary|(S)- Methadone Trough Plasma Concentration||Day 1, Day 7, Day 21|||ng/mL||Standard Deviation|Mean
825486|NCT01191242|Primary|(S)- Methadone Peak Plasma Concentration||Day 1, Day 7, Day 21|||ng/mL||Standard Deviation|Mean
825487|NCT01191242|Primary|Total Methadone Trough Plasma Concentration||Day 1, Day 7, Day 21|||ng/mL||Standard Deviation|Mean
825488|NCT01191242|Primary|Total Methadone Peak Plasma Concentration||Day 1, Day 7, Day 21|||ng/mL||Standard Deviation|Mean
825489|NCT01191255|Secondary|ESA Analysis|Full analysis population, cumulative Erythropoiesis-stimulating agent (ESA) administration from baseline to the end of the Safety Assessment Period (Week 52)|52 weeks|||Units/Day||Full Range|Median
825490|NCT01191255|Secondary|IV Iron Analysis|Full Analysis Population, cumulative IV Iron administration from Baseline to the end of the Safety Assessment Period (Week 52)|52 weeks|||mg/day||Full Range|Median
825491|NCT01191255|Secondary|Change in Mean Serum Transferrin Saturation (TSAT) From Baseline to the End of the Safety Assessment Period (Week 52)||52 weeks|Full Analysis Population (LOCF)||% Saturation||Standard Deviation|Mean
825492|NCT01191255|Secondary|Change in Mean Serum Ferritin From Baseline to Week 52||52 weeks|Full Analysis Population (LOCF)||ng/mL||Standard Deviation|Mean
825493|NCT01191255|Primary|Change in Mean Serum Phosphorus From Baseline (Week 52) to the End of the Efficacy Assessment Period (EAP; Week 56)|Patients who completed the 52-week Safety Assessment Period (SAP) on KRX-0502 (ferric citrate) were randomized in a 1:1 ratio to receive either KRX-0502 (ferric citrate) or Placebo for 4 weeks.|4 weeks|Full Analysis Population (LOCF)||mg/dL||Standard Deviation|Mean
825494|NCT01191268|Secondary|Number of Participants With Treatment Emergent Adverse Events up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose|A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with one or more TEAE is summarized cumulatively at 26 weeks, 52 weeks, and 4 weeks after last dose. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 weeks, 52 weeks, and 4 weeks after last dose|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine.||participants|||Number
825538|NCT01191736|Secondary|The Proportion of Subjects Who Assessed the Responsiveness of the Victim (Manikin) as Judged by Expert Raters|The proportion of the subjects who assessed the responsiveness of the victim (manikin) as judged by expert raters|60 minutes after intervention and two months after intervention|||Proportion of Participants||95% Confidence Interval|Mean
825495|NCT01191268|Secondary|Number of Participants With Treatment Emergent LY2189265 Antibodies up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose|A participant was considered to have treatment emergent LY2189265 anti-drug antibodies (ADA) if the participant had at least one titer that was treatment-emergent relative to baseline, defined as a 4-fold or greater increase in titer from baseline measurement.|Baseline through 4 weeks after last dose|Participants who received at least one dose of LY2189265 with evaluable LY2189265 ADA data.||participants|||Number
825496|NCT01191268|Secondary|Number of Participants With Adjudicated Cardiovascular Events up to 52 Weeks|Deaths and nonfatal cardiovascular adverse events (AEs) were adjudicated by a committee of physicians with cardiology expertise external to the Sponsor. The nonfatal cardiovascular AEs to be adjudicated include myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions (such as coronary artery bypass graft or percutaneous coronary intervention), and cerebrovascular events including cerebrovascular accident (stroke) and transient ischemic attack. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine.||participants|||Number
825497|NCT01191268|Secondary|Rate of Self-reported Hypoglycemic Events up to 52 Weeks|Hypoglycemic events (HE) were classified as severe (episodes requiring the assistance of another person to actively administer resuscitative actions and had a plasma glucose [PG] of ≤ 70 milligrams per deciliter [mg/dL]), documented symptomatic (any time a participant felt that he/she was experiencing symptoms and/or signs associated with hypoglycemia and had a PG of ≤ 70 mg/dL), or asymptomatic (events not accompanied by typical symptoms of hypoglycemia but with a measured PG of ≤ 70 mg/dL). The 1-year adjusted rate of hypoglycemic events is summarized cumulatively at 52 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine. Only pre-rescue measurements were used.||events per participant per year||Standard Deviation|Mean
825498|NCT01191268|Secondary|Number of Participants With Self-reported Hypoglycemic Events up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose|Hypoglycemic events (HE) were classified as severe (episodes requiring the assistance of another person to actively administer resuscitative actions and had a plasma glucose [PG] of ≤ 70 milligrams per deciliter [mg/dL]), documented symptomatic (any time a participant felt that he/she was experiencing symptoms and/or signs associated with hypoglycemia and had a PG of ≤ 70 mg/dL), or asymptomatic (events not accompanied by typical symptoms of hypoglycemia but with a measured PG of ≤ 70 mg/dL). The number of participants with self-reported hypoglycemic events is summarized cumulatively. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 weeks and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine. Only pre-rescue measurements were used.||participants|||Number
825499|NCT01191268|Secondary|Number of Events of Adjudicated Pancreatitis up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose|The number of adjudicated (by an independent Clinical Endpoint Committee [CEC]) pancreatic events is summarized at 52 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine.||events|||Number
825500|NCT01191268|Secondary|Change From Baseline to 26 and 52 Weeks in Electrocardiogram Parameters, Heart Rate|Electrocardiogram (ECG) heart rate was measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, metformin use, and treatment-by-visit interaction as fixed effects and baseline value as a covariate.|Baseline, 26 weeks, and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable ECG heart rate data.||beats per minute (bpm)||Standard Error|Least Squares Mean
825501|NCT01191268|Secondary|Change From Baseline to 26 and 52 Weeks in Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. PR is the interval between the P wave and the QRS complex. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, metformin use, and treatment-by-visit interaction as fixed effects and baseline value as a covariate.|Baseline, 26 weeks, and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable ECG QTcF or PR Interval data.||milliseconds (msec)||Standard Error|Least Squares Mean
825502|NCT01191268|Secondary|Pulse Rate at Baseline, 52 Weeks, and 4 Weeks After Last Dose|Seated pulse rate was measured.|Baseline and 52 weeks and 4 weeks after last dose|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable seated pulse rate data.||beats per minute (bpm)||Standard Deviation|Mean
825503|NCT01191268|Secondary|Change From Baseline to 26 and 52 Weeks in Pulse Rate|Seated pulse rate was measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, metformin use, and treatment-by-visit interaction as fixed effects and baseline as a covariate|Baseline, 26 weeks, and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable seated pulse rate data.||beats per minute (bpm)||Standard Error|Least Squares Mean
825504|NCT01191268|Secondary|Blood Pressure at Baseline, 52 Weeks, and 4 Weeks After Last Dose|Seated systolic blood pressure (SBP) and seated diastolic blood pressure (DBP) were measured.|Baseline and 52 weeks and 4 weeks after last dose|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable blood pressure data.||milliliters of mercury (mmHg)||Standard Deviation|Mean
825539|NCT01191736|Primary|Median Compression Depth (mm)|Assessment of resuscitation skills using a Laerdal Resusci Annie recording manikin and Laerdal PC Skill Reporting software|60 minutes after intervention or two months after intervention|Per protocol||millimeters||Inter-Quartile Range|Median
826071|NCT01195701|Secondary|Free Testosterone|Free testosterone and the calculated free androgen index will be compared; additionally, these levels will be correlated with the questionnaire data and clitoral measurements|Between day 1-14 (follicular phase) of menstrual cycle|||pg/mL||Inter-Quartile Range|Median
825505|NCT01191268|Secondary|Change From Baseline to 26 and 52 Weeks in Blood Pressure|Seated systolic blood pressure (SBP) and seated diastolic blood pressure (DBP) were measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, metformin use, and treatment-by-visit interaction as fixed effects and baseline blood pressure as a covariate.|Baseline, 26 weeks, and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable blood pressure data.||milliliters of mercury (mmHg)||Standard Error|Least Squares Mean
825506|NCT01191268|Secondary|Serum Calcitonin at Baseline, 52 Weeks, and 4 Weeks After Last Dose||Baseline and 52 weeks and 4 weeks after last dose|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable serum calcitonin data.||picomole per liter||Standard Deviation|Mean
825507|NCT01191268|Secondary|Change From Baseline to 26 and 52 Weeks in Serum Calcitonin||Baseline, 26 weeks, and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable serum calcitonin data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing||picogram per milliliter (pcg/mL)||Inter-Quartile Range|Median
825508|NCT01191268|Secondary|Pancreatic Enzymes at Baseline, 52 Weeks, and 4 Weeks After Last Dose|Amylase (total and pancreas-derived [PD]) and lipase concentrations were measured at baseline and at 4 weeks after last dose (ALD).|Baseline and 52 weeks and 4 weeks after last dose|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable pancreatic enzyme data.||units per liter (U/L)||Standard Deviation|Mean
825509|NCT01191268|Secondary|Change From Baseline to 26 and 52 Weeks in Pancreatic Enzymes|Amylase (total and pancreas-derived [PD]) and lipase concentrations were measured.|Baseline, 26 weeks, and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable pancreatic enzyme data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||units per liter (U/L)||Inter-Quartile Range|Median
825510|NCT01191268|Secondary|Change From Baseline to 26 and 52 Weeks in the Low Blood Sugar Survey (LBSS)|The Low Blood Sugar Survey (LBSS) contains 33 items comprised of 2 subscales (behavior and worry), each of which is rated on a 5-point numeric rating scale from 0 (never) to 4 (almost always). It captures behavioral changes associated with the concerns and experiences of hypoglycemia and the degree to which participants are worried about certain aspects associated with hypoglycemia during the previous 4 weeks. The behavior (or avoidance) subscale has 15 items, and the worry (or affect) subscale has 18 items. Subscale scores are calculated by summing participant responses to items (behavior range 0-60; worry range 0-72). A total score is calculated as the sum of both subscales (range 0-132). Higher scores indicate greater negative impact on subscales and total score. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country, treatment and metformin use as fixed effects and baseline score as a covariate.|Baseline, 26 weeks, and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable LBSS data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||units on a scale||Standard Error|Least Squares Mean
825511|NCT01191268|Secondary|Change From Baseline to 26 and 52 Weeks in the Impact of Weight on Self-Perception (IW-SP)|The Impact of Weight on Self-Perception (IW-SP) questionnaire contains 3 items that assess how often the participants' body weight affects how happy they are with their appearance and how often they feel self-conscious when out in public. Items are scored on a 5-point numeric rating scale where 5 = never and 1 = always. A single total score is calculated by summing the scores for all 3 items. Total score ranges between 3 and 15, where a higher score is indicative of better self-perception. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country, treatment, and metformin use as fixed effects and baseline score as a covariate.|Baseline, 26 weeks, and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable IW-SP data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||units on a scale||Standard Error|Least Squares Mean
825512|NCT01191268|Secondary|Change From Baseline to 26 and 52 Weeks in the Impact of Weight on Activities of Daily Living (IW-ADL)|"The Impact of Weight on Activities of Daily Living questionnaire (renamed the Ability to Perform Physical Activities of Daily Living Questionnaire [APPADL]) contains 7 items that assess how difficult it is for participants to engage in certain activities considered to be integral to normal daily life, such as walking, standing and climbing stairs. Items are scored on a 5-point numeric rating scale where 5 = not at all difficult and 1 = unable to do. The individual scores from all 7 items are summed and a single total score is calculated and may range between 7 and 35. A higher score indicates better ability to perform activities of daily living. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country, treatment, and metformin use as fixed effects and baseline score as a covariate."|Baseline, 26 weeks, and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable APPADL data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||units on a scale||Standard Error|Least Squares Mean
825522|NCT01191268|Secondary|Change From Baseline to 52-week Endpoint in Glycosylated Hemoglobin (HbA1c)|Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, baseline metformin, and baseline HbA1c.|Baseline, 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable HbA1c data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
825556|NCT01191944|Secondary|Change From Baseline in UPDRS II Score Separately at Week 18|UPDRS Part II (activities of daily living) ranges from 0 to 52. Reduction over time represents an improvement. Means are adjusted for treatment, centre and baseline.|Baseline and week 18|FAS (LOCF)||Units on a scale||Standard Error|Least Squares Mean
825513|NCT01191268|Secondary|Change From Baseline to 26 and 52 Weeks in the EQ-5D|The EQ-5D questionnaire is a generic, multidimensional, health-related, quality-of-life instrument. It consists of 2 parts: the first part assesses 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that have 3 possible levels of response (no problem, some problem, or extreme problem). These dimensions are converted into a weighted health-state Index Score. The EQ-5D United Kingdom (UK) score ranges from -0.59 to 1.0, where a score of 1.0 indicates perfect health and negative values are valued as worse than dead. The second part consists of a visual analog scale (VAS) on which the participants rated their perceived health state on that day from 0 (worst imaginable health state) to 100 (best imaginable health). Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, metformin use, and baseline.|Baseline, 26 weeks, and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable EQ-5D data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||units on a scale||Standard Error|Least Squares Mean
825514|NCT01191268|Secondary|Change From Baseline to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose in Body Mass Index (BMI)|Body mass index is an estimate of body fat based on body weight divided by height squared. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, metformin use, and treatment-by-visit interaction as fixed effects and baseline BMI as a covariate.|Baseline, 26 weeks, and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable BMI data.||kilograms per meter squared (kg/m^2)||Standard Error|Least Squares Mean
825515|NCT01191268|Secondary|Body Weight at Baseline, 52 Weeks, and 4 Weeks After Last Dose||Baseline and 52 weeks and 4 weeks after last dose|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable body weight data.||kilograms (kg)||Standard Deviation|Mean
825516|NCT01191268|Secondary|Change From Baseline to 26 and 52 Weeks in Body Weight|Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country, treatment, and metformin use as fixed effects and baseline body weight as a covariate.|Baseline, 26 weeks, and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable body weight data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||kilograms (kg)||Standard Error|Least Squares Mean
825517|NCT01191268|Secondary|Total Daily Insulin Dose Overall and by Components (Insulin Lispro and Insulin Glargine)|Total daily insulin (TDI) dose was reported at baseline, 26 weeks, and 52 weeks. Daily Insulin Lispro and Insulin Glargine doses were reported at 26 and 52 weeks.|Baseline and 26 weeks and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine.||units||Standard Deviation|Mean
825518|NCT01191268|Secondary|Change From Baseline to 26 and 52 Weeks in Fasting Serum Glucose|Fasting serum glucose was measured by the central laboratory. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, metformin use, and treatment-by-visit interaction as fixed effects and baseline fasting blood glucose as a covariate.|Baseline, 26 weeks, and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable fasting blood glucose data. Only pre-rescue measurements were used.||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
825519|NCT01191268|Secondary|Change From Baseline to 26 and 52 Weeks in Blood Glucose Values From the 8-point Self-monitored Plasma Glucose (SMPG) Profiles|The self-monitored plasma glucose (SMPG) data were collected at the following 8 time points: pre-morning meal; 2 hours post-morning meal; pre-midday meal; 2 hours post-midday meal; pre-evening meal; 2 hours post-evening meal; bedtime; and 3AM or 5 hours after bedtime. The mean of the 8 time points (Daily Mean) was also calculated. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, metformin, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26 weeks, and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable SMPG data. Only pre-rescue measurements were used.||millimoles per liter (mmol/L)]||Standard Error|Least Squares Mean
825520|NCT01191268|Secondary|Change From Baseline to 26 and 52 Weeks in the Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c) Less Than 7% Without Nocturnal or Severe Hypoglycemia|The percentage of participants achieving HbA1c less than 7.0% without nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking) or severe (episodes requiring the assistance of another person to actively administer resuscitative actions) hypoglycemia was analyzed with a repeated logistic regression model (generalized estimating equation model) with baseline HbA1c, baseline metformin, country, and treatment as factors included in the model.|Baseline, 26 weeks, and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||percentage of participants|||Number
825521|NCT01191268|Secondary|Percentage of Participants Attaining Glycosylated Hemoglobin (HbA1c) Less Than 7% and Less Than or Equal to 6.5% at Weeks 26 and 52|The percentage of participants achieving HbA1c level less than 7.0% and less than or equal to 6.5% was analyzed with a repeated logistic regression model (generalized estimating equation model) with baseline HbA1c, baseline metformin, country, and treatment as factors included in the model.|26 weeks and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable HbA1c data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||percentage of participants|||Number
825537|NCT01191723|Primary|Change From Baseline in QTcI for MAP0004 3.0mg and Placebo at 30 Minutes|The corrected QT interval, individualized (QTcI) is a measurement of the electrical impulses through the largest part of the heart muscle individualized for subject pre-dose values. A negative change is a shortening of the QTc interval, a positive change is a lengthening of the QTc interval.|baseline and 30 minutes|Patients with data available at required time point were included in the analysis population.||milliseconds||Standard Deviation|Mean
825523|NCT01191268|Primary|Change From Baseline to 26-week Endpoint in Glycosylated Hemoglobin (HbA1c)|Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, baseline metformin, and baseline HbA1c.|Baseline, 26 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable HbA1c data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
825524|NCT01191320|Primary|Change in HbA1C|The change in HbA1c from Baseline to 3 Months for each treatment arm|3 months|ITT population||Ratio||Standard Deviation|Mean
825525|NCT01191398|Secondary|Monitoring of Adverse Events During Study Administration|Subjects will be monitored for episodes of apnea, laryngospasm, vomiting, oxygen desaturation(<92%), and changes in heart rate and blood pressure. The time frame will include the time the study medication is administered until at least 30 minutes post Ketamine administration.|1 hour|||adverse events|||Number
825526|NCT01191398|Primary|Difference in Salivary Flow Rate (ml/Min) Between Study Groups|Oral Secretions will be collected by oral suctioning starting at the time Ketamine is administed until 30 minutes post Ketamine administration. Suctionings will be done by trained personnel every 5 minutes starting with the Ketamine administration. Flow rate will be calculated by dividing the total volume of saliva suctioned by the total time suctioned (30 minutes)|30 minutes|||ml/min||Standard Deviation|Mean
825527|NCT01191411|Primary|Colorectal Cancer Screening Participation, Defined as Completion of a Guaiac or Immunochemical Stool Occult Blood Test, Colonoscopy, Sigmoidoscopy, or Barium Enem.|To compare participation rates for screening between those receiving (a) mailed invitation to screening (immunochemical stool blood test (MailFIT) or colonoscopy(MailColo)) and (b) traditional visit-based screening (VisitBased), rates for these groups will be contrasted via a Chi-squared test. A p value<0.025 will be considered statistically significant.|1 year|Overall, out of 1593 patients assigned to FIT outreach, 648 were screened; out of 479 assigned to colonoscopy outreach, 118 were screened; and out of 3898 assigned to usual care, 471 were screened.||percentage of participants|||Number
825528|NCT01191476|Secondary|Time to Orientation|Time to orientation was measured from the time sevoflurane or propofol administration was stopped until orientation (able to state their name and date of birth).|Every minute after anesthesia was stopped until orientation occurred|||Minutes||Standard Deviation|Mean
825529|NCT01191476|Secondary|Time to Extubation|Time to extubation was measured from the time sevoflurane or propofol administration was stopped until tracheal extubation occurred. Criteria to determine extubation included a train of four stimulus > 0.9 (a method to measure the magnitude and type of neuromuscular block, a ratio of the fourth response to the first one), a tidal volume > 5 mL/kg, minute ventilation > 3 L, a respiratory rate of > 10 breaths/minute, an end tidal carbon dioxide < 45 mmHg, and eye opening has occurred.|Every minute after anesthesia was stopped until extubation occurred|Measurement||Minutes||Standard Deviation|Mean
825530|NCT01191476|Secondary|Time to Eye Opening|Measured from the time sevoflurane or propofol administration was stopped until the subject's eyes were opened. The investigator tapped the subject on the forehead or shoulder after anesthesia was stopped and asked them to open their eyes. This process was repeated approximately every minute until eye opening occurred.|Every minute after anesthesia was stopped until the subjects' eyes opened|||Minutes||Standard Deviation|Mean
825531|NCT01191476|Secondary|Time to Loss of Consciousness|Loss of consciousness was measured from the time the anesthetic was administered until loss of consciousness (no response to command) occurred. Inhalational induction was induced with sevoflurane via vital capacity induction at 8%. Intravenous induction was induced with propofol at 4 µg/mL via target controlled infusion (TCI). In subjects who received both anesthetic agents, a bolus dose of propofol 1.5 mg/kg was used for induction.|Up to 10 minutes|||seconds||Standard Deviation|Mean
825532|NCT01191476|Primary|Cost of Volatile Induction and Maintenance Anesthesia (VIMA) With Sevoflurane, Total Intravenous Anesthesia (TIVA) With Propofol, or Intravenous Induction With Propofol and Inhalational Maintenance With Sevoflurane|"[Cost of VIMA = unit price of sevoflurane X used volume of sevoflurane];
[Cost of TIVA = unit price of propofol X total volume of propofol in the syringe];
[Cost of Propofol Induction and Sevoflurane Maintenance = unit price of propofol X total volume of propofol in the syringe + unit price of sevoflurane X volume of sevoflurane in the syringe].
The total volume of propofol in the syringe was calculated, even if all the anesthetic was not used, because it could not be reused."|Anesthetic Duration between 1 to 3 Hours|The full analysis set was used for the determination of cost of anesthesia.||Yuan||Standard Deviation|Mean
825533|NCT01191723|Secondary|Change From Baseline in Heart Rate for MAP0004 3.0mg, Placebo, and Moxifloxacin at 30 Minutes and 2 Hours|The heart rate is a measure of how fast or slow the heart beats (measured in beats per minute). A negative change indicates a decrease in heart rate and a positive change indicates an increase in heart rate.|baseline, 30 minutes, and 2 hours|Patients with data available at required time point were included in the analysis population.||beats per minute (bpm)||Standard Deviation|Mean
825534|NCT01191723|Secondary|Change From Baseline in QTcF for MAP0004 3.0mg, Placebo, and Moxifloxacin at 2 Hours|The Fridericia corrected QT interval(QTcF) is a measurement of the electrical impulses through the largest part of the heart muscle. A negative change is a shortening of the QTc interval, a positive change is a lengthening of the QTc interval.|baseline and 2 hours|Patients with data available at required time point were included in the analysis population.||milliseconds||Standard Deviation|Mean
825535|NCT01191723|Secondary|Change From Baseline in QTcF for MAP0004 3.0mg and Placebo at 30 Minutes|The Fridericia corrected QT interval(QTcF) is a measurement of the electrical impulses through the largest part of the heart muscle. A negative change is a shortening of the QTc interval, a positive change is a lengthening of the QTc interval.|baseline and 30 minutes|Patients with data available at required time point were included in the analysis population.||milliseconds||Standard Deviation|Mean
825536|NCT01191723|Primary|Change From Baseline in QTcI for MAP0004 3.0mg, Placebo, and Moxifloxacin at 2 Hours|The corrected QT interval, individualized (QTcI) is a measurement of the electrical impulses through the largest part of the heart muscle individualized for subject pre-dose values. A negative change is a shortening of the QTc interval, a positive change is a lengthening of the QTc interval.|baseline and 2 hours|Patients with data available at required time point were included in the analysis population.||milliseconds||Standard Deviation|Mean
825540|NCT01191749|Primary|Overall Response - Number of Participants Who Achieved Complete Remission (CR)+Partial Remission (PR) - as Per International Working Group (IWG) Response Criteria|Overall response (OR) defined as complete/partial remission for at least 4 weeks or hematologic improvement for at least 8 weeks. Response Criteria are according to the Modified IWG Response Criteria in Myelodysplasia. IWG 2006 response criteria - CR: bone marrow evaluation shows less than or equal to (<=) 5% blasts; normal maturation of all cells lines (mCR), peripheral blood evaluation shows hemoglobin >= 11 gram per deciliter (g/dL), neutrophils >= 1000/mL, platelets >= 100,000/mL, 0% blasts; PR: Same as CR, except blasts decrease by >=50%, still greater than 5% in bone marrow. Hematologic improvement are measured in participants with pretreatment abnormal values: hemoglobin level less than 110 g/L (11 g/dL) or red blood count (RBC)-transfusion dependence, platelet count <100 x 10^9/L or platelet-transfusion dependence, absolute neutrophil count (ANC) less than 1.0 x 10^9/L.|Up to 6 months following treatment; response assessed every 2 months|One subject’s response was indeterminate due to the absence of end of therapy assessments.||participants|||Number
825541|NCT01191762|Primary|Fractional Change in [PTH] in CKD After a 4-week Course of Sevelamer Carbonate|This outcome measure documented the effect of intestinal phosphate-binding on [PTH]. Fractional change was calculated as ([PTH]post - [PTH]pre)/[PTH]pre, where 'pre' and 'post' referred respectively to baseline [PTH] (before treatment) and [PTH] after four weeks of treatment. Reductions were cited as negative numbers, and increments were cited as positive numbers.|4 weeks|||percentage of baseline [PTH]||Standard Error|Mean
825542|NCT01191788|Secondary|Mental Health Functioning as Measured by SF-12 MCS.|The SF-12 is a 12 question, self-administered measure of general health functioning. The SF-12 outputs a mental health summary score (MCS), which ranges from 0 to 100, with higher scores indicating better mental health functioning. MCS scores are standardized such that mean = 50 and SD = 10 in the general U.S. population.|3 Months Post Treatment|||SF-12 score||Standard Deviation|Mean
825543|NCT01191788|Primary|Depressive Symptoms as Measured by the Beck Depression Inventory II|The Beck Depression Inventory II (BDI-II) is a 21 question, self-administered measure of depressive symptoms. Scores range from 0 - 63, with higher scores indicating more severe depressive symptoms.|3 Months Post Treatment|||BDI-II score||Standard Deviation|Mean
825544|NCT01191801|Other Pre-specified|Leukemia-Free Survival (LFS)|Durability of remission (CR) assessed by LFS|Up to 5 years or the duration of the study|Subset of Intent to Treat patients that have a Measured CR||Months||95% Confidence Interval|Median
825545|NCT01191801|Other Pre-specified|Event Free Survival (EFS)||Up to 5 years or duration of study|Intent to Treat Population||months||95% Confidence Interval|Median
825546|NCT01191801|Other Pre-specified|Overall Remission (OR) Rate Based on the IWG Response Criteria|"Group A patient OR compared to Group B patient OR
Overall Remission includes Complete Remission (CR), Complete Remission with incomplete platelet recovery (CRp), Complete Remission with incomplete blood count recovery (CRi), and Partial Remission (PR). Complete remission means bone marrow blast count of less than 5% with adequate recovery of peripheral blood counts as typically defined by the IWG. Both CRi and CRp refer complete remission but with incomplete blood count and platelet recovery, respectively. PR, or partial remission, refers to remission in which bone marrow contains blast counts between 5 and 25 percent."|Up to 5 years or the duration of the study|Intent to Treat Population||percentage of participants||95% Confidence Interval|Number
825547|NCT01191801|Secondary|All Cause Mortality|Vosaroxin + cytarabine mortality versus placebo + cytarabine mortality|60 Days|Safety Population (705)||percentage of Participants||95% Confidence Interval|Number
825548|NCT01191801|Secondary|All Cause Mortality|Vosaroxin + cytarabine mortality versus placebo + cytarabine mortality|30 Days|Safety Population (705)||percentage of Participants in the Group||95% Confidence Interval|Number
825549|NCT01191801|Secondary|Complete Remission (CR) Rate Based on Modified International Working Group (IWG) Criteria.|Group A (Vosaroxin + cytarabine) patient CR as compared to Group B (placebo + cytarabine) patient CR. Complete remission (CR) is typically defined using IWG criteria as bone marrow blast count of less than 5% with adequate recovery of peripheral blood counts.|Up to 5 years or duration of study|The percentage of patients who achieved CR was adjudicated by the CPARR (Central Pathology and Response Review) panel using modified IWG response criteria. The outcome measure reflects the Intent to Treat Population.||percentage of particpants||95% Confidence Interval|Number
825550|NCT01191801|Primary|Overall Survival|Vosaroxin + cytarabine patient survival versus placebo + cytarabine patient survival|Up to 5 years or duration of study|The intent-to-treat (ITT) population which consists of all patients enrolled (randomly assigned to treatment group).||Months||95% Confidence Interval|Median
825551|NCT01191827|Primary|Neuronal Response During Sensory Gating|Neuronal response (blood oxygenation level dependent functional magnetic resonance imaging signal, relative to the global mean) during sensory gating. Sensory gating is defined as the process of filtering out unnecessary environmental stimuli.|Immediate|||% BOLD signal||Standard Deviation|Mean
825552|NCT01191944|Secondary|Levodopa (L-Dopa) Dose Change During the Study|Although the number of patients who began the study with concomitant L-dopa supplementation and required a change in dosage was not analysed for this study, the change from baseline in L-dopa dose is presented.|18 weeks|FAS. Only patients with concomitant L-Dopa treatment at baseline.||mg||Standard Deviation|Mean
825553|NCT01191944|Secondary|Levodopa (L-Dopa) Introduction During the Study|Number of patients without concomitant L-Dopa treatment at baseline which required L-Dopa supplementation during the study.|18 weeks|FAS. Only patients without concomitant L-Dopa treatment at baseline.||Participants|||Number
825554|NCT01191944|Secondary|Change From Baseline in UPDRS III Score Separately at Week 18|UPDRS Part III (motor examination) ranges from 0 to 108. Reduction over time represents an improvement. Means are adjusted for treatment, centre and baseline.|Baseline and week 18|FAS (LOCF)||Units on a scale||Standard Error|Least Squares Mean
825555|NCT01191944|Other Pre-specified|Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score at 18 Weeks|ESS is a patient-report scale with 8 items rating how likely one is to fall asleep during passive and inconsequential situations such as watching television, more active situations such as sitting and talking to someone, or consequential situations such as sitting in a car, while stopped for a few minutes in traffic. The likelihood of dozing off is rated from 0 points (no chance) to 3 points (high chance). The overall rating scale is scored from 0 (no daytime sleep) to 24 (worst daytime sleep).|Baseline and week 18|Observed cases (OC). Only patients with ESS assessment at baseline and at 18 weeks were analyzed.||Units on a scale||Standard Deviation|Mean
825557|NCT01191944|Secondary|Responder in UPDRS Parts II+III Score at Week 18|Responders were defined as patients with at least a 20 percent improvement of UPDRS II+III score relative to baseline. UPDRS II+III ranges 0-160 scores from best to worst and was calculated as the sum of Part II (activities of daily living, ranges from 0 to 52) and Part III (motor examination, ranges from 0 to 108).|Baseline and week 18|FAS (LOCF)||Participants|||Number
825558|NCT01191944|Secondary|Patient Global Impressions of Improvement (PGI-I) Responder at Week 18|The PGI-I scale is a patient-rated instrument which was used to measure the improvement of a patients PD symptoms throughout the study. Ranging from 1 point=very much better to 7 points=very much worse. Responders were defined as patients having score 1 or 2 (at least much better) when comparing the past week to the assessment at baseline.|18 weeks|FAS (LOCF)||Participants|||Number
825559|NCT01191944|Secondary|Clinical Global Impression of Improvement (CGI-I) Responder at Week 18|CGI-I was used to assess the overall status of Parkinsons disease (PD) after interviewing the patient about the various aspects of the PD and after evaluating adverse events and concomitant treatments. Ranging from 1 point=very much improved to 7 points=very much worse. Responders were defined as patients having score 1 or 2 (at least much improved) when comparing the past week to the assessment at baseline.|18 weeks|FAS (LOCF). Only patients with on-treatment CGI-I evaluation were analyzed.||Participants|||Number
825560|NCT01191944|Secondary|Change From Baseline in Duration of On-time With Troublesome Dyskinesia at Week 18|Duration of on-time with troublesome Dyskinesia based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). On-time describes a period during which a patient was relatively free of Parkinsons symptoms (e.g. mobile or capable of moving with relative ease and independence). Dyskinesia qualified as troublesome if it interfered with function or caused meaningful discomfort. Decrease in the duration represents an improvement. Means are adjusted for treatment, centre and baseline.|Baseline and week 18|FAS (LOCF) reduced to patients with advanced PD. Advanced PD patients were those reporting at least 2 hours of off-time daily during each of the two days before baseline, as recorded in the patient diary.||hours||Standard Error|Least Squares Mean
825561|NCT01191944|Secondary|Change From Baseline in Duration of On-time Without or With Non-troublesome Dyskinesia at Week 18|Duration of on-time without Dyskinesia or with non-troublesome Dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period during which a patient was relatively free of Parkinsons symptoms (e.g. mobile or capable of moving with relative ease and independence). Dyskinesia qualified as non-troublesome if it did not interfere with function or did not cause meaningful discomfort. Increase in the duration represents an improvement. Means are adjusted for treatment, centre and baseline.|Baseline and week 18|FAS (LOCF) reduced to patients with advanced PD. Advanced PD patients were those reporting at least 2 hours of off-time daily during each of the two days before baseline, as recorded in the patient diary.||hours||Standard Error|Least Squares Mean
825562|NCT01191944|Secondary|Change From Baseline in Duration of On-time With Non-troublesome Dyskinesia at Week 18|Duration on-time with non-troublesome Dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period during which a patient was relatively free of Parkinsons symptoms (e.g. mobile or capable of moving with relative ease and independence). Dyskinesia qualified as non-troublesome if it did not interfere with function or did not cause meaningful discomfort. Increase in the duration represents an improvement. Means are adjusted for treatment, centre and baseline.|Baseline and week 18|FAS (LOCF) reduced to patients with advanced PD. Advanced PD patients were those reporting at least 2 hours of off-time daily during each of the two days before baseline, as recorded in the patient diary.||hours||Standard Error|Least Squares Mean
825563|NCT01191944|Secondary|Change From Baseline in Duration of On-time Without Dyskinesia at Week 18|Duration of on-time without Dyskinesia based on patient diary data. On-time describes a period during which a patient was relatively free of Parkinsons symptoms (e.g. mobile or capable of moving with relative ease and independence). Increase in the duration represents an improvement. Means are adjusted for treatment, centre and baseline.|Baseline and week 18|FAS (LOCF) reduced to patients with advanced PD. Advanced PD patients were those reporting at least 2 hours of off-time daily during each of the two days before baseline, as recorded in the patient diary.||hours||Standard Error|Least Squares Mean
825564|NCT01191944|Secondary|Change From Baseline in Percentage On-time With Troublesome Dyskinesia at Week 18|Percentage on-time with troublesome Dyskinesia based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). On-time describes a period during which a patient was relatively free of Parkinsons symptoms (e.g. mobile or capable of moving with relative ease and independence). Dyskinesia qualified as troublesome if it interfered with function or caused meaningful discomfort. Decrease in the percentage represents an improvement. Means are adjusted for treatment, centre and baseline.|Baseline and week 18|FAS (LOCF) reduced to patients with advanced PD. Advanced PD patients were those reporting at least 2 hours of off-time daily during each of the two days before baseline, as recorded in the patient diary.||Percentage of on-time||Standard Error|Least Squares Mean
825565|NCT01191944|Secondary|Change From Baseline in Percentage On-time Without or With Non-troublesome Dyskinesia at Week 18|Percentage on-time without or with non-troublesome Dyskinesia based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). On-time describes a period during which a patient was relatively free of Parkinsons symptoms (e.g. mobile or capable of moving with relative ease and independence). Dyskinesia qualified as non-troublesome if it did not interfere with function or did not cause meaningful discomfort. Increase in the percentage represents an improvement. Means are adjusted for treatment, centre and baseline.|Baseline and week 18|FAS (LOCF) reduced to patients with advanced PD. Advanced PD patients were those reporting at least 2 hours of off-time daily during each of the two days before baseline, as recorded in the patient diary.||Percentage of on-time||Standard Error|Least Squares Mean
825566|NCT01191944|Secondary|Change From Baseline in Percentage On-time With Non-troublesome Dyskinesia at Week 18|Percentage on-time with non-troublesome Dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period during which a patient was relatively free of Parkinsons symptoms (e.g. mobile or capable of moving with relative ease and independence). Dyskinesia qualified as non-troublesome if it did not interfere with function or did not cause meaningful discomfort. Increase in the percentage represents an improvement. Means are adjusted for treatment, centre and baseline.|Baseline and week 18|FAS (LOCF) reduced to patients with advanced PD. Advanced PD patients were those reporting at least 2 hours of off-time daily during each of the two days before baseline, as recorded in the patient diary.||Percentage of on-time||Standard Error|Least Squares Mean
825567|NCT01191944|Secondary|Change From Baseline in Percentage On-time Without Dyskinesia at Week 18|Percentage on-time without Dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period during which a patient was relatively free of Parkinsons symptoms (e.g. mobile or capable of moving with relative ease and independence). Increase in the percentage represents an improvement. Means are adjusted for treatment, centre and baseline.|Baseline and week 18|FAS (LOCF) reduced to patients with advanced PD. Advanced PD patients were those reporting at least 2 hours of off-time daily during each of the two days before baseline, as recorded in the patient diary.||Percentage of on-time||Standard Error|Least Squares Mean
825568|NCT01191944|Secondary|Responder in Percentage Off-time During Waking Hours at Week 18|Percentage off-time based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). Off-time describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease). Reduction over time represents an improvement. Responders were defined as patients with at least a 20 percent improvement relative to baseline.|Baseline and week 18|FAS (LOCF) reduced to patients with advanced PD. Advanced PD patients were those reporting at least 2 hours of off-time daily during each of the two days before baseline, as recorded in the patient diary.||Participants|||Number
825569|NCT01191944|Secondary|Change From Baseline in Duration of Off-time During Waking Hours at Week 18|Duration of off-time during waking hours based on patient diary data. Off-time describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease). Reduction over time represents an improvement. Means are adjusted for treatment, centre and baseline.|Baseline and week 18|FAS (LOCF) reduced to patients with advanced PD. Advanced PD patients were those reporting at least 2 hours of off-time daily during each of the two days before baseline, as recorded in the patient diary.||hours||Standard Error|Least Squares Mean
825570|NCT01191944|Secondary|Change From Baseline in Percentage Off-time During Waking Hours at Week 18|Percentage off-time during waking hours based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). Off-time describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease). Reduction over time represents an improvement. Means are adjusted for treatment, centre and baseline.|Baseline and week 18|FAS (LOCF) reduced to patients with advanced Parkinsons Disease (PD). Advanced PD patients were those reporting at least 2 hours of off-time daily during each of the two days before baseline, as recorded in the patient diary.||Percentage off-time||Standard Error|Least Squares Mean
825571|NCT01191944|Primary|Change From Baseline in Unified Parkinsons Disease Rating Scale (UPDRS) Parts II+III Score at Week 18|UPDRS total score ranges from 0 (best) to 160 (worst) and was calculated as the sum of Part II (activities of daily living, ranges from 0 to 52) and Part III (motor examination, ranges from 0 to 108). Reduction over time represents an improvement. Means are adjusted for treatment, centre and baseline.|Baseline and week 18|Full analysis set (FAS) with last observation carried forward (LOCF). FAS is defined as all randomised patients which received at least one dose of study drug and provided any post baseline efficacy assessment.||Units on a scale||Standard Error|Least Squares Mean
825572|NCT01192022|Secondary|Time to Intraoperative Hemostasis at Target Bleeding Site|The target bleeding area was observed at 3, 4, 5, 8, 9, and 10 minutes after the patch was applied to see if the bleeding stopped, and time in minutes until bleeding stopped was recorded.|10 minutes|Full Analysis set included all randomized participants analyzed according to the treatment assigned.||minutes||Full Range|Median
825573|NCT01192022|Secondary|Percentage of Participants With Intraoperative Hemostasis at Target Bleeding Site Within 5 Minutes|3, 4 and 5 minutes after the patch was applied to the target bleeding area, the area was observed to see if the bleeding stopped.|within 5 minutes|Full Analysis set included all randomized participants analyzed according to the treatment assigned.||percentage of participants||95% Confidence Interval|Number
825574|NCT01192022|Primary|Percentage of Participants With Intraoperative Hemostasis at Target Bleeding Site Within 3 Minutes|3 Minutes after the patch was applied to the target bleeding area, the area was observed to see if the bleeding stopped.|within 3 minutes|Full Analysis set included all randomized participants analyzed according to the treatment assigned.||percentage of participants||95% Confidence Interval|Number
825575|NCT01192126|Primary|Slit Lamp Examination > Grade 2|Slit lamp findings for each eye will be assessed at each study visit, including epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates, will be graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). Slit lamp > 2.|All study visits from screening through 2 week follow-up|All Dispensed Eyes||Eyes|Participants||Number
825576|NCT01192126|Primary|Visual Acuity|Distance High contrast logMAR visual acuity (VA), difference between the test and control lens at dispensing visit and 1 week follow-up, crossover visit and 1 week follow-up.|Dispensing Visit and 1 week follow-up|All Eligible Dispensed Eyes||LogMAR|Participants|Standard Deviation|Mean
825577|NCT01192139|Secondary|Safety: Clinically Significant Laboratory, Vital Sign, Physical Examination, and Electrocardiogram (ECG) Abnormalities|Abnormalities considered by the investigator to be clinically significant and/or reported as an AE.|From Day 1 of Period 1 through Day 3 of Period 3 (study discharge)|Safety Population||Participants|||Number
825578|NCT01192139|Secondary|Safety: Adverse Events (AEs), Discontinuations Due to AEs, Deaths, and Serious AEs (SAEs)|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.|AEs: from initiation of study drug administration on Day 1/Period 1 through study discharge Day 3/Period 3. SAEs: from date of written consent until 30 days after discontinuation of dosing or participation in study if last scheduled visit occurred later.|Safety Population = all participants who received any study drug.||Participants|||Number
825579|NCT01192139|Secondary|Metformin Fraction of AUC(0-inf) Contributed by AUC(0-t)(AUC[0-t]/AUC[0-inf])||Period 1 (before dosing, 0.167,0.25,0.5,0.75,1,1.5,2,3,4,5,6,7,8,10,12,18,24,36 and 48 hours after dosing)|Treated participants (the smaller sample size for AUC(0-inf) was due to the inability to estimate Kel for some of the subjects).||ratio||Standard Deviation|Mean
825581|NCT01192139|Secondary|Metformin T1/2|terminal half life; calculated as ln(2)/Kel|Period 1 (before dosing, 0.167,0.25,0.5,0.75,1,1.5,2,3,4,5,6,7,8,10,12,18,24,36 and 48 hours after dosing)|Treated participants (the smaller sample size for T1/2 was due to the inability to estimate Kel for some of the subjects).||hours||Standard Deviation|Mean
825582|NCT01192139|Primary|Metformin Cmax||Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)|All treated participants||ng/mL||Standard Deviation|Mean
825583|NCT01192139|Secondary|Metformin AUC(0-t)|Area under the plasma concentration versus time curve from time 0 to the time of the last quantifiable concentration (Ct), calculated using the linear trapezoidal rule.|Period 1 (samples taken before dosing, and at 0.167,0.25,0.5,0.75,1,1.5,2,3,4,5,6,7,8,10,12,18,24,36 and 48 hours after dosing)|All treated participants||ng*hr/mL||Standard Deviation|Mean
825584|NCT01192139|Primary|Metformin AUC(0-inf)|Area under the plasma concentration versus time curve from time 0 extrapolated to infinity; calculated as AUC0-t [calculated using the linear trapezoidal rule] + Ct/Kel, where Ct was the last measurable concentration and Kel was the terminal rate constant|Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)|Treated participants (the smaller sample size for AUC[0-inf] was due to the inability to estimate potassium chloride for some participants)||ng*hr/mL||Standard Deviation|Mean
825585|NCT01192139|Secondary|Active Metabolite BMS-510849 AUC(0-t)/AUC(0-inf)||Period 1 (samples taken before dosing, and at 0.167,0.25,0.5,0.75,1,1.5,2,3,4,5,6,7,8,10,12,18,24,36 and 48 hours after dosing)|All treated participants||ratio||Standard Deviation|Mean
825586|NCT01192139|Secondary|Active Metabolite BMS-510849 Tmax||Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)|All treated participants||hours||Standard Deviation|Mean
825587|NCT01192139|Secondary|Active Metabolite BMS-510849 T1/2|terminal half life; calculated as ln(2)/Kel|Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)|All treated participants||hours||Standard Deviation|Mean
825588|NCT01192139|Secondary|Active Metabolite BMS-510849 Cmax||Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)|All treated participants||ng/mL||Standard Deviation|Mean
825589|NCT01192139|Secondary|Active Metabolite BMS-510849 AUC(0-t)|Area under the plasma concentration versus time curve from time 0 to the time of the last quantifiable concentration (Ct), calculated using the linear trapezoidal rule.|Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)|All treated participants||ng*hr/mL||Standard Deviation|Mean
825590|NCT01192139|Secondary|Active Metabolite BMS-510849 AUC(0-inf)|Area under the plasma concentration versus time curve from time 0 extrapolated to infinity; calculated as AUC0-t [calculated using the linear trapezoidal rule] + Ct/Kel, where Ct was the last measurable concentration and Kel was the terminal rate constant|Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)|All treated participants||ng*hr/mL||Standard Deviation|Mean
825591|NCT01192139|Secondary|Saxagliptin Fraction of AUC(0-inf) Contributed by AUC(0-t) (AUC[0-t]/AUC[0-inf])||Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)|All treated participants||ratio||Standard Deviation|Mean
825592|NCT01192139|Secondary|Time to Achieve the Observed Maximum Saxagliptin Plasma Concentration (Tmax)||Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)|All treated participants||hours||Standard Deviation|Mean
825593|NCT01192139|Primary|Saxagliptin Observed Maximum Plasma Concentration (Cmax)||Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)|All treated participants||ng/mL||Standard Deviation|Mean
825594|NCT01192139|Secondary|Saxagliptin Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-t])|Area under the plasma concentration versus time curve from time 0 to the time of the last quantifiable concentration (Ct), calculated using the linear trapezoidal rule.|Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)|All treated participants||ng*hr/mL||Standard Deviation|Mean
825595|NCT01192139|Secondary|Saxagliptin Terminal Half-life (T1/2)|terminal half life; calculated as ln(2)/Kel|Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)|All treated participants||hours||Standard Deviation|Mean
825596|NCT01192139|Primary|Saxagliptin Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity (AUC[0-inf])|Area under the plasma concentration versus time curve from time 0 extrapolated to infinity; calculated as AUC0-t [calculated using the linear trapezoidal rule] + Ct/Kel, where Ct was the last measurable concentration and Kel was the terminal rate constant|Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)|All treated participants||ng*hr/mL||Standard Deviation|Mean
825597|NCT01192152|Secondary|Safety: Clinically Significant Laboratory, Vital Sign, Physical Examination, and/or 12-Lead Electrocardiogram (ECG) Abnormalities|Abnormalities considered clinically significant and/or reported as an AE by the investigator.|From Day 1 of Period 1 to Day 3 of Period 2 for participants in Treatment Sequence BA and Day 5 of Period 3 for participants in Treatment Sequence ABC|All subjects who received at least one dose of study medication.||participants|||Number
825615|NCT01192152|Secondary|5-hydroxy Saxagliptin Cmax||Periods 1 & 2:predose, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36, 48 hours postdose. Period 3: predose on Days 2 & 3; predose, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24 hours postdose on Day 4.|All treated participants not discontinuing prior to end of study.||ng/mL||Standard Deviation|Mean
825616|NCT01192152|Secondary|5-hydroxy Saxagliptin AUC(0-tau)||Period 3: predosing on Days 2 and 3; predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, and 24 hours postdosing on Day 4.|All treated participants not discontinuing prior to end of study.||ng*hr/mL||Standard Deviation|Mean
825598|NCT01192152|Secondary|Safety: Adverse Events (AEs), Discontinuations Due to AEs, Deaths, and Serious AEs (SAEs)|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.|AEs: from initiation of study drug administration on morning of Day 1/Period 1 through study discharge. SAEs: from date of written consent until 30 days after discontinuation of dosing or participation in study if last scheduled visit occurred later.|All subjects who received at least one dose of study medication.||participants|||Number
825599|NCT01192152|Secondary|Metformin Tmax||Periods 1 & 2:predose, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36, 48 hours postdose. Period 3: predose on Days 2 & 3; predose, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24 hours postdose on Day 4.|All treated participants not discontinuing prior to end of study.||hour||Standard Deviation|Mean
825600|NCT01192152|Secondary|Metformin AUC(0-inf) Contributed by AUC(0-t)(AUC[0-t]/AUC[0-inf])||Periods 1 and 2: predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36 and 48 hours postdosing.|All treated participants not discontinuing prior to end of study. 2 participants in Treatment A & 1 in Treatment B were excluded as a result of the inability to estimate with acceptable accuracy a terminal slope for terminal phase concentration data. Treatment C was administered only during Period 3, & this measure was analyzed for Periods 1 and 2.||ratio||Standard Deviation|Mean
825601|NCT01192152|Secondary|Metformin T1/2||Periods 1 and 2: predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36 and 48 hours postdosing.|All treated participants not discontinuing prior to the end of study. One participant in Treatment A was excluded as a result of the inability to estimate with acceptable accuracy a terminal slope for the terminal phase concentration data. Treatment C was administered only during Period 3, and this outcome measure was analyzed for Periods 1 and 2.||ng*hr/mL||Standard Deviation|Mean
825602|NCT01192152|Secondary|Metformin Fluctuation %||Period 3: predosing on Days 2 and 3; predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, and 24 hours postdosing on Day 4.|All treated participants not discontinuing prior to end of study.||percentage of fluctuation||Standard Deviation|Mean
825603|NCT01192152|Secondary|Metformin Cavg||Period 3: predosing on Days 2 and 3; predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, and 24 hours postdosing on Day 4.|All treated participants not discontinuing prior to end of study.||ng/mL||Standard Deviation|Mean
825604|NCT01192152|Secondary|Metformin Cmin||Period 3: predosing on Days 2 and 3; predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, and 24 hours postdosing on Day 4.|All treated participants not discontinuing prior to end of study.||ng/mL||Standard Deviation|Mean
825605|NCT01192152|Primary|Metformin Cmax||Periods 1 & 2:predose, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36, 48 hours postdose. Period 3: predose on Days 2 & 3; predose, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24 hours postdose on Day 4.|All treated participants not discontinuing prior to end of study.||ng/mL||Standard Deviation|Mean
825606|NCT01192152|Secondary|Metformin AUC(0-tau)||Period 3: predosing on Days 2 and 3; predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, and 24 hours postdosing on Day 4.|All treated participants not discontinuing prior to end of study.||ng*hr/mL||Standard Deviation|Mean
825607|NCT01192152|Secondary|Metformin AUC(0-t)||Periods 1 and 2: predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36 and 48 hours postdosing.|All treated participants not discontinuing prior to end of study. Treatment C was administered only during Period 3, and this outcome measure was analyzed for Periods 1 and 2.||ng*hr/mL||Standard Deviation|Mean
825608|NCT01192152|Primary|Metformin AUC(0-inf)||Periods 1 and 2: predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36 and 48 hours postdosing.|All treated participants not discontinuing prior to end of study. 2 participants in Treatment A & 1 in Treatment B were excluded due to the inability to estimate with acceptable accuracy a terminal slope for terminal phase concentration data. Treatment C administered only during Period 3, and this outcome measure was analyzed for Periods 1 and 2.||ng*hr/mL||Standard Deviation|Mean
825609|NCT01192152|Secondary|5-hydroxy Saxagliptin Tmax||Periods 1 & 2:predose, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36, 48 hours postdose. Period 3: predose on Days 2 & 3; predose, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24 hours postdose on Day 4.|All treated participants not discontinuing prior to end of study.||hour||Standard Deviation|Mean
825610|NCT01192152|Secondary|5-hydroxy Saxagliptin AUC(0-t)/AUC(0-inf)||Periods 1 and 2: predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36 and 48 hours postdosing.|All treated participants not discontinuing prior to the end of study. One participant in Treatment A was excluded as a result of the inability to estimate with acceptable accuracy a terminal slope for the terminal phase concentration data. Treatment C was administered only during Period 3, and this outcome measure was analyzed for Periods 1 and 2.||ratio||Standard Deviation|Mean
825611|NCT01192152|Secondary|5-hydroxy Saxagliptin T1/2||Periods 1 and 2: predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36 and 48 hours post-dosing.|All treated participants not discontinuing prior to the end of study. One participant in Treatment A was excluded as a result of the inability to estimate with acceptable accuracy a terminal slope for the terminal phase concentration data. Treatment C was administered only during Period 3, and this outcome measure was analyzed for Periods 1 and 2.||ng*hr/mL||Standard Deviation|Mean
825612|NCT01192152|Secondary|5-hydroxy Saxagliptin Fluctuation %||Period 3: predosing on Days 2 and 3; predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, and 24 hours postdosing on Day 4.|All treated participants not discontinuing prior to end of study.||percentage of fluctuation||Standard Deviation|Mean
825613|NCT01192152|Secondary|5-hydroxy Saxagliptin Cavg||Period 3: predosing on Days 2 and 3; predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, and 24 hours postdosing on Day 4.|All treated participants not discontinuing prior to end of study.||ng/mL||Standard Deviation|Mean
825614|NCT01192152|Secondary|5-hydroxy Saxagliptin Cmin||Period 3: predosing on Days 2 and 3; predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, and 24 hours postdosing on Day 4.|All treated participants not discontinuing prior to end of study.||ng/mL||Standard Deviation|Mean
825617|NCT01192152|Secondary|5-hydroxy Saxagliptin AUC(0-t)||Periods 1 and 2: predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36 and 48 hours postdosing.|All treated participants not discontinuing prior to end of study. Treatment C was administered only during Period 3, and this outcome measure was analyzed for Periods 1 and 2.||ng*hr/mL||Standard Deviation|Mean
825618|NCT01192152|Secondary|5-hydroxy Saxagliptin AUC(0-inf)||Periods 1 and 2: predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36 and 48 hours postdosing.|All treated participants not discontinuing prior to the end of study. One participant in Treatment A was excluded as a result of the inability to estimate with acceptable accuracy a terminal slope for the terminal phase concentration data. Treatment C was administered only during Period 3, and this outcome measure was analyzed for Periods 1 and 2.||ng*hr/mL||Standard Deviation|Mean
825619|NCT01192152|Secondary|Saxagliptin Time to Achieve the Observed Maximum Plasma Concentration (Tmax)||Periods 1 & 2:predose, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36, 48 hours postdose. Period 3: predose on Days 2 & 3; predose, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24 hours postdose on Day 4.|All treated participants not discontinuing prior to end of study.||hour||Standard Deviation|Mean
825620|NCT01192152|Secondary|Saxagliptin Fraction of AUC(0-inf) Contributed by AUC(0-t) (AUC[0-t]/AUC[0-inf])||Periods 1 and 2: predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36 and 48 hours postdosing.|All treated participants not discontinuing prior to the end of study. One participant in Treatment A was excluded as a result of the inability to estimate with acceptable accuracy a terminal slope for the terminal phase concentration data. Treatment C was administered only during Period 3, and this outcome measure was analyzed for Periods 1 and 2.||ratio||Standard Deviation|Mean
825621|NCT01192152|Secondary|Saxagliptin Terminal Half-life (T1/2)||Periods 1 and 2: predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36 and 48 hours postdosing.|All treated participants not discontinuing prior to the end of study. One participant in Treatment A was excluded as a result of the inability to estimate with acceptable accuracy a terminal slope for the terminal phase concentration data. Treatment C was administered only during Period 3, and this outcome measure was analyzed for Periods 1 and 2.||ng*hr/mL||Standard Deviation|Mean
825622|NCT01192152|Secondary|Saxagliptin Degree of Fluctuation Over the Dosing Interval (Fluctuation %)||Period 3: predosing on Days 2 and 3; predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, and 24 hours postdosing on Day 4.|All treated participants not discontinuing prior to end of study.||percentage of fluctuation||Standard Deviation|Mean
825623|NCT01192152|Secondary|Saxagliptin Average Plasma Concentration Over the Dosing Period (Cavg)||Period 3: predosing on Days 2 and 3; predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, and 24 hours postdosing on Day 4.|All treated participants not discontinuing prior to end of study.||ng/mL||Standard Deviation|Mean
825624|NCT01192152|Secondary|Saxagliptin Trough (Predose) Plasma Concentration (Cmin)||Period 3: predosing on Days 2 and 3; predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, and 24 hours postdosing on Day 4.|All treated participants not discontinuing prior to end of study.||ng/mL||Standard Deviation|Mean
825625|NCT01192152|Primary|Saxagliptin Observed Maximum Plasma Concentration (Cmax)||Periods 1 & 2: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36 & 48 hrs post-dosing. Period 3: predosing on Days 2 & 3; predosing, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24 hrs postdosing on Day 4|All treated participants not discontinuing prior to end of study.||ng/mL||Standard Deviation|Mean
825626|NCT01192152|Secondary|Saxagliptin Area Under the Plasma Concentration Versus Time Curve From Time 0 to the End of the Dosing Interval (AUC[0-tau])|Dosing interval = 24 hours.|Period 3: pre-dosing on Days 2 and 3; pre-dosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, and 24 hours post-dosing on Day 4.|All treated participants not discontinuing prior to end of study.||ng*hr/mL||Standard Deviation|Mean
825627|NCT01192152|Secondary|Saxagliptin Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-t])||Periods 1 and 2: pre-dosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36 and 48 hours post-dosing.|All treated participants not discontinuing prior to end of study. Treatment C was administered only during Period 3, and this outcome measure was analyzed for Periods 1 and 2.||ng*hr/mL||Standard Deviation|Mean
825628|NCT01192152|Primary|Saxagliptin Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity (AUC[0-inf])||Periods 1 and 2: pre-dosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36 and 48 hours post-dosing.|All treated participants not discontinuing prior to the end of study. One participant in Treatment A was excluded as a result of the inability to estimate with acceptable accuracy a terminal slope for the terminal phase concentration data. Treatment C was administered only during Period 3, and this outcome measure was analyzed for Periods 1 and 2.||ng*hr/mL||Standard Deviation|Mean
825629|NCT01192178|Secondary|Mean Percentage of Rescue-free Days|A rescue-free day was defined as a day during the Peak Viral Period on which no puffs of rescue medication were recorded. Percentage of rescue-free days was defined as the number of days during the Peak Viral Period on which no puffs of rescue medication were recorded, divided by the number of days in that same period on which non-missing values were recorded, multiplied by 100.|Peak Viral Period (from 30 August 2010 through the end of treatment [up to Week 16])|ITT Population. Only those participants who recorded data during the Peak Viral Period and had a treatment stop date with a defined Peak Viral Period were analyzed.||Percentage of days||Standard Deviation|Mean
825630|NCT01192178|Secondary|Mean Percentage of Symptom-free Days|A symptom-free day was defined as a day during the Peak Viral Period on which the asthma symptom score was zero. The daily asthma symptom score (measured during the day and the previous night) was reported on a 6-point scale (ranging from 0=no symptoms to 5=severe symptoms). Percentage of symptom-free days was defined as the number of days during the Peak Viral Period on which the asthma symptom score=0, divided by the number of days in that same period on which non-missing values were recorded, multiplied by 100.|Peak Viral Period (from 30 August 2010 through the end of treatment [up to Week 16])|ITT Population. Only those participants who recorded data during the Peak Viral Period and had a treatment stop date with a defined Peak Viral Period were analyzed.||Percentage of days||Standard Deviation|Mean
826072|NCT01195701|Primary|Clitoral Measurements Using Pelvic MRI|All cases and controls will undergo a pelvic MRI without contrast to assess the clitoral complex.|Between day 1-14 (follicular phase) of menstrual cycle|||millimeters (mm)||Standard Deviation|Mean
825631|NCT01192178|Secondary|Mean Percentage of Episode-free (EF) Days|An EF day was defined as a day without any of the following: rescue albuterol use, use of oral/parenteral corticosteroids for asthma, use of asthma medication other than study treatment, asthma symptom score >0, nighttime awakenings due to asthma, unscheduled health care visits (defined as home visits, office visits, or urgent care visits), ER visits, hospitalizations for asthma, school absenteeism due to asthma, or morning peak expiratory flow (measure of maximum airflow) <80% of baseline. Percentage of EF days=No. of EF days divided by No. of days of treatment exposure, multiplied by 100.|Peak Viral Period (from 30 August 2010 through the end of treatment [up to Week 16])|ITT Population. Only those participants who recorded data during the Peak Viral Period, had a treatment stop date with a defined Peak Viral Period, and had available data on all days on which data were recorded were analyzed.||Percentage of days||Standard Error|Mean
825632|NCT01192178|Secondary|Mean Percentage of Asthma-control Days|An asthma-control day was defined as a day without any of the following: rescue albuterol use, use of oral/parenteral corticosteroids for asthma, use of asthma medication other than double-blind study treatment, asthma symptom score >0, nighttime awakenings due to asthma, unscheduled health care visits (defined as home visits, office visits, or urgent care visits), ER visits, hospitalizations for asthma, or school absenteeism due to asthma. The percentage of asthma-control days = the number (No.) of asthma-control days divided by the No. of days of treatment exposure, multiplied by 100.|Peak Viral Period (from 30 August 2010 through the end of treatment [up to Week 16])|ITT Population. Only those participants who recorded data during the Peak Viral Period, had a treatment stop date with a defined Peak Viral Period, and had available data on all days on which data were recorded were analyzed.||Percentage of days||Standard Error|Mean
825633|NCT01192178|Secondary|Number of Asthma Exacerbations Associated With the Presence of Moderate or Severe URTS or a Confirmed RV Infection During the Peak Viral Period|Each participant (with assistance from the parent/legal guardian as needed) was instructed to keep an electronic diary (eDiary) with record of daily URTS symptoms that included: runny nose, sneezing, nasal congestion, and sore throat. Based on the best-described aggregate URTS during the previous 24 hours, participants rated symptoms as: 0 = Not present; 1 = Mild, clearly present; 2 = Moderately severe, uncomfortable; and 3 = Severe, interfering with sleep or activity. Mucus samples were collected and analyzed for RVwhen the eDiary alerted for moderate/severe URTS.|Peak Viral Period (from 30 August 2010 through the end of treatment [up to Week 16])|ITT Population. Only those participants who reported >=1 exacerbation were analyzed. Only those participants with moderate or severe URTS or a confirmed RV infection were analyzed.||Number of asthma exacerbations|||Number
825634|NCT01192178|Secondary|Mean Duration of Worsening Asthma Symptoms Associated With the Presence of Moderate or Severe URTS or a Confirmed RV Infection|A worsening asthma day is one on which any of the following occurred: rescue albuterol use above baseline, use of oral/parenteral corticosteroids for asthma, use of asthma medication other than study medication, asthma symptom scores >=3, nighttime awakenings, unscheduled health care visits, or missed school due to asthma. The duration of worsening asthma is the number of consecutive worsening asthma days after the date of a URTS score of 2 (moderate) or 3 (severe) or collection of a mucus sample containing RV (whichever occurred first). Each span of consecutive days is a participant interval.|Peak Viral Period (from 30 August 2010 through the end of treatment [up to Week 16])|ITT Population. Only those participants with relevant data defining a worsening asthma day during the peak viral period and with moderate or severe URTS or a confirmed RV infection were analyzed.||Days per participant interval||Standard Error|Mean
825635|NCT01192178|Secondary|Mean Asthma Symptom Scores, as an Indicator of Severity, Associated With the Presence of Moderate or Severe Upper Respiratory Tract Symptoms (URTS) or a Confirmed Rhinovirus (RV) Infection at Baseline and During the Peak Viral Period|Participants recorded their asthma symptom score over the previous 24 hours (during the day and the previous night) using the following 6-point scale: 0=No symptoms; 1=Symptoms for 1 short period; 2=Symptoms for >=2 short periods; 3=Symptoms for most of the day/previous night that did not affect normal daily activities; 4=Symptoms for most of the day/previous night that affected normal daily activities; 5=Symptoms so severe that participant could not perform normal daily activities. The Baseline mean asthma symptom score was calculated as the average score over 7 days prior to Week 1, Visit 2.|Baseline (Week 1) and Peak Viral Period ([period during which the greatest number of viral infections is expected] from 30 August 2010 through the end of the treatment period [up to Week 16])|ITT Population. Only those participants with moderate or severe URTS or a confirmed RV infection were analyzed.||Scores on a scale||Standard Deviation|Mean
825636|NCT01192178|Primary|Total Number of Asthma Exacerbations Reported During the Treatment Period|An asthma exacerbation was defined as deterioration of asthma that required the use of outpatient oral/parenteral corticosteroids (tablets, suspensions, or injection) or an urgent care, hospitalization, or emergency room (ER) visit due to asthma that required oral/parenteral corticosteroids. Two exacerbations (out of a total of 51) were excluded: (1) one exacerbation occurred within 7 days of the resolution of an earlier one, and, per protocol, was combined with the previous exacerbation; and (2) one exacerbation occurred post treatment.|From Baseline (Week 1) until the end of treatment (up to Week 16)|Intent-to-Treat (ITT) Population: all participants randomized to treatment. Only those participants who reported >=1 exacerbation were analyzed.||Number of asthma exacerbations|||Number
825637|NCT01192191|Secondary|Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings|A 12-lead ECG was recorded in a supine position after the participant was kept at rest in this position for at least 5 minutes at assessment time points (Week 12, Week 24, and Week52). Data are presented for clinically significant (CS) as well as not clinically significant (NCS) abnormal findings. Any abnormal ECG, including those that worsen from baseline, and clinically significant as assessed by the investigator were recorded as CS.|Baseline (Week -2), Week 12, Week 24, and Week 52|"ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X."||Participants|||Number
825638|NCT01192191|Secondary|Change From Baseline in Heart Rate (HR) at Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD|Heart rate was measured in a sitting position after a participant was kept at rest for at least 5 minutes at assessment time points (Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD). Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Week 0), Week 4, Week 8, Week 12, Week 16, Week 24, Week 32, Week 40, Week 52, Week 24/WD, Week 52/WD|ITT Population. Only those participants with post-Baseline data available at the indicated time points were analyzed.||Beats/Minute||Standard Deviation|Mean
825639|NCT01192191|Secondary|Change From Baseline in Blood Pressure at Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD|Blood pressure measurement included systolic blood pressure (SBP) and diastolic blood pressure (DBP) at Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD. Blood pressure was measured in a sitting position after a participant was kept at rest for at least 5 minutes. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Week 0), Week 4, Week 8, Week 12, Week 16, Week 24, Week 32, Week 40, Week 52, Week 24/WD, and Week 52/WD|ITT Population. Only those participants with post-Baseline data available at the indicated time points were analyzed.||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
825640|NCT01192191|Secondary|Change From Baseline in 24-hour Urinary Cortisol Excretion at Weeks 24 and 52/Withdrawal (WD)|24-hour urinary cortisol excretion was calculated by multiplying the total volume of urine by the concentration of urinary cortisol. Cortisol is a hormone released from the adrenal gland that helps in fat, protein, and carbohydrate metabolism. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Week 0), Week 24, and Week 52/Withdrawal (WD)|The Urine Cortisol Population: all participants in the ITT Population for whom a urine sample was obtained and whose urine sample was not considered to have confounding factors that could affect the interpretation of the results. Only those participants with post-Baseline data available at the indicated time points were analyzed.||Nanomoles (nmol)/24 hours||Geometric Coefficient of Variation|Geometric Mean
825641|NCT01192191|Secondary|Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline (BL) and Week 52/Withdrawal (WD)|Urinalysis parameters included: Urine Occult Blood (UOB), Urine Glucose (UG), Urine Ketones (UK), Urine Protein (UP), and Urine Leukocyte Esterase test for detecting White Blood Cell (UWBC). The dipstick was a strip used to detect the presence or absence of these parameters in the urine sample. The dipstick test gives results in a semi-quantitative manner, and results can be read as negative (Neg), Trace, 1+, 2+, and 3+, indicating proportional concentrations in the urine sample. Data are reported as the number of participants who had neg, trace, 1+, 2+, and 3+ levels at Baseline (Week -2) and Week 52/WD.|Baseline (Week -2), Week 52/Withdrawal (WD)|"ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X."||Participants|||Number
825642|NCT01192191|Secondary|Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD)|Clinical chemistry and urinalysis parameters included: Albumin, Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Bilirubin (Direct [BD], Indirect [BI], and Total [BT]), Creatine Kinase (CK), Chloride, Carbon Dioxide content/Bicarbonate (CO2/BC), Creatinine, Gamma Glutamyl Transferase (GGT), Glucose, Potassium, Lactate Dehydrogenase (LDH), Sodium, Urine pH, Urine Specific Gravity (USG),Total Protein (TP), Urea/Blood urea nitrogen (BUN), and Uric Acid (UA). Data are reported as the number of participants who had low, normal, and high levels at BL (Week-2) and Week 52/WD.|Baseline (Week -2), and Week 52/Withdrawal (WD|"ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X."||Participants|||Number
825643|NCT01192191|Secondary|Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD)|Hematological parameters included: Basophils (Baso), Eosinophils (Eosin), Lymphocytes (Lymph), Monocytes (Mono), Total Neutrophils (TN), Hemoglobin (Hemo), Hematocrit (Hmcrt), Platelet Count (PT), Red Blood Cell Count (RBC Count), White Blood Cell Count (WBC Count). Data are reported as the number of participants who had low, normal, and high levels at BL (Week-2) and Week 52/WD.|Baseline (Week -2), and Week 52/Withdrawal (WD)|"ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X."||Participants|||Number
825644|NCT01192191|Secondary|Number of Participants With Pneumonia During the Treatment Period|Pneumonia is an inflammatory condition of the lung, affecting primarily the microscopic air sacs known as alveoli. All diagnoses of pneumonia (radiographically confirmed or unconfirmed) were reported as an AE or SAE. An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the ot|From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD])|ITT Population||Participants|||Number
825645|NCT01192191|Primary|Number of Participants With Any Drug-related AE and Any Drug-related SAE Throughout the Treatment Period|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury. Relatedness was assessed by the investigator.|From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD])|ITT Population||Participants|||Number
825646|NCT01192191|Primary|Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Treatment Period|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs (occurring at a frequency threshold >=5%) and SAEs.|From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD])|Intent-to-Treat (ITT) Population: all participants who had been randomized to and received at least one dose of randomized medication in the treatment period||Participants|||Number
825647|NCT01192204|Secondary|Treatment Changes in Loss of Heterozygosity Events|Laboratory experiments will be conducted to assess the effects of gel treatment on pre and post loss of heterozygosity (LOH) events at loci associated with tumor suppressor genes.|Before and after the 3 month treatment duration|||LOH events||Standard Error|Mean
825648|NCT01192204|Secondary|Changes in Lesional Sizes|The remaining oral dysplasia lesion will be inspected at each follow up appointment (every 10-14 days). Biopsies will be immediately conducted on patients with any indication of malignant transformation including indurated, rolled borders, nonhealing ulcers, etc. Accordingly, these patients will withdraw from the trial. Participants will also be monitored for any changes consistent with contact mucositis e.g. soreness and erythema at application site. Clinical photographs were taken for the patients records. Pre treatment and post treatment photographs, with a ruler in place, were used for accurate pre and post treatment size measurement. NOTE: if treatment is beneficial, lesional size will decrease which will be reflected as a negative number.|pretreatment and posttreatment (3 months treatment duration)|||mm^2||Standard Deviation|Mean
825649|NCT01192204|Primary|Light Microscopic Histologically Scored Diagnoses Pretreatment to Post Treatment|A hemisection of lesional tissue will be conducted before the 3 month treatment to establish a diagnosis and provide a pretreatment baseline for the experimental parameters. Anl excisional biopsy of the treatment site including any remaining residual lesional tissue (excision of oral dysplastic lesions is consistent with current standards of care) will be obtained after 3 months of treatment to provide a posttreatment diagnosis. The 0 to 8 histologic scale was:0=normal with or without hyperkeratosis BEST OUTCOME, 1=atypia, 2=mild dysplasia, 3=mild-moderate dysplasia, 4=moderate dysplasia,5=moderate-severe dysplasia,6=severe dysplasia, 7=carcinoma in situ, 8=invasive oral squamous cell carcinoma (WORST OUTCOME).|Before and after the 3 month treatment.|The population evaluated were as previously described i.e. 22 participants in the BRB gel cohort and 18 participants in the placebo gel cohort.||unit on histologic grade scale||Standard Error|Mean
825650|NCT01192282|Primary|Commonest HPV Genotypes Isolated by HIV Status|10 commonest types of HPV isolated according to HIV status|18 months|||Participants|||Number
825651|NCT01192282|Primary|Number of HPV Genotypes Isolated by HIV Status|Number of HPV Genotypes isolated according to HIV Status|Up to 18 months|119 out of 126 uncontaminated samples were HPV DNA Positive. Out of these 119 HPV DNA Positive Samples, 12 were B-Globin Positive but no specific HPV Genotype could be identifiable.||participants|||Number
825652|NCT01192282|Primary|HPV DNA and Pap Smear Results|Relationship between HPV DNA Positivity and Pap Smear Results|18 Months|Only 118 out of 119 patients with HPV DNA Positive had a Pap Smear done. One patient was a Virgin and hence no Pap Smear was done.||Participants|||Number
825653|NCT01192282|Primary|HPV DNA and HIV Status|HPV DNA Positivity and HIV Status|18 Months|Only 126 out of 156 samples collected from each patients were analysed as 30 of the samples were contaminated, of which 22 were from HIV Positive patients and 8 were from HIV Negative patients.||participants|||Number
825662|NCT01192347|Secondary|Maximum Daily Dose of Anagrelide Hydrochloride||6 months|Safety Set comprised all subjects who had taken at least 1 dose of Anagrelide Hydrochloride and had at least 1 post-baseline safety assessment documented.||mg/day||Standard Deviation|Mean
825663|NCT01192347|Secondary|Summary of Adverse Drug Reactions: When the Dosing Was Inconsistent With the Summary of Product Characteristics (SmPC)|"Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when XAGRID treatment was initiated, using the following variables:
Initiation of XAGRID dosing consistent with the Summary of Product Characteristics (SmPC):
Consistent if:
The starting dose was <=1 mg/day, AND
Any increase in dose was no more than 0.5mg/day, AND
Any increase in dose was made at least 7 days after first initiation or at least 7 days after any previous modification (up or down), AND
The maximum dose did not exceed 10 mg/day at any stage.
Inconsistent: in all other cases"|6 months|Safety Set comprised all subjects who had taken at least 1 dose of Anagrelide Hydrochloride and had at least 1 post-baseline safety assessment documented.||percentage of subjects|||Number
825664|NCT01192347|Secondary|Summary of Adverse Drug Reactions: When the Dosing Was Consistent With the Summary of Product Characteristics (SmPC)|"Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when XAGRID treatment was initiated, using the following variables:
Initiation of XAGRID dosing consistent with the Summary of Product Characteristics (SmPC):
Consistent if:
The starting dose was <=1 mg/day, AND
Any increase in dose was no more than 0.5mg/day, AND
Any increase in dose was made at least 7 days after first initiation or at least 7 days after any previous modification (up or down), AND
The maximum dose did not exceed 10 mg/day at any stage.
Inconsistent: in all other cases"|6 months|Safety Set comprised all subjects who had taken at least 1 dose of Anagrelide Hydrochloride and had at least 1 post-baseline safety assessment documented.||percentage of subjects|||Number
825665|NCT01192347|Secondary|Summary of Adverse Drug Reactions: No Withdrawal of Previous Cytoreductive Therapy|"Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables:
•Withdrawal of previous cytoreductive therapy:
Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation
After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up
Not Withdrawn: in all other cases"|6 months|Safety Set comprised all subjects who had taken at least 1 dose of Anagrelide Hydrochloride and had at least 1 post-baseline safety assessment documented.||percentage of subjects|||Number
825666|NCT01192347|Secondary|Summary of Adverse Drug Reactions: Withdrawal of Previous Cytoreductive Therapy After Anagrelide Hydrochloride Initiation|"Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables:
•Withdrawal of previous cytoreductive therapy:
Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation
After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up
Not Withdrawn: in all other cases"|6 months|Safety Set comprised all subjects who had taken at least 1 dose of Anagrelide Hydrochloride and had at least 1 post-baseline safety assessment documented.||percentage of subjects|||Number
825684|NCT01192516|Secondary|Physical Function- Six Minute Walk|Six minute walk is the distance (in feet) that people walk at a usual pace over 6 minutes|Baseline|Numbers may vary due to missing data||feet||Standard Deviation|Mean
825685|NCT01192516|Primary|Pain- WOMAC|This is a 5 item pain scale in which items on a scale of 0 - 4 are summed. A higher score means more pain.|6 months post baseline|Numbers may vary due to missing data||units on a scale||Standard Deviation|Mean
825667|NCT01192347|Secondary|Summary of Adverse Drug Reactions (ADR): Withdrawal of Previous Cytoreductive Therapy Before Anagrelide Hydrochloride Initiation|"Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables:
•Withdrawal of previous cytoreductive therapy:
Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation
After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up
Not Withdrawn: in all other cases"|6 months|Safety Set comprised all subjects who had taken at least 1 dose of Anagrelide Hydrochloride and had at least 1 post-baseline safety assessment documented.||percentage of subjects|||Number
825668|NCT01192347|Primary|Percentage of Subjects Achieving Platelet Target Response: When the Dosing Was Inconsistent With the Summary of Product Characteristics (SmPC)|"Full response is a platelet count of <400x10^9/L. Partial response is a platelet count between 400-600x10^9/L or a platelet count reduction of 200x10^9.
Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when XAGRID treatment was initiated, using the following variables:
Initiation of XAGRID dosing consistent with the Summary of Product Characteristics (SmPC):
Consistent if:
The starting dose was <=1 mg/day, AND
Any increase in dose was no more than 0.5mg/day, AND
Any increase in dose was made at least 7 days after first initiation or at least 7 days after any previous modification (up or down), AND
The maximum dose did not exceed 10 mg/day at any stage.
Inconsistent: in all other cases"|6 months|Full Analysis Set (FAS) comprised all enrolled patients for whom Anagrelide Hydrochloride therapy was initiated. Subjects who had not taken any previous cytoreductive therapy other than Anagrelide Hydrochloride were excluded from the FAS.||percentage of subjects||95% Confidence Interval|Number
825669|NCT01192347|Primary|Percentage of Subjects Achieving Platelet Target Response: When the Dosing Was Consistent With the Summary of Product Characteristics (SmPC)|"Full response is a platelet count of <400x10^9/L. Partial response is a platelet count between 400-600x10^9/L or a platelet count reduction of 200x10^9.
Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when XAGRID treatment was initiated, using the following variables:
Initiation of XAGRID dosing consistent with the Summary of Product Characteristics (SmPC):
Consistent if:
The starting dose was <=1 mg/day, AND
Any increase in dose was no more than 0.5mg/day, AND
Any increase in dose was made at least 7 days after first initiation or at least 7 days after any previous modification (up or down), AND
The maximum dose did not exceed 10 mg/day at any stage.
Inconsistent: in all other cases"|6 months|Full Analysis Set (FAS) comprised all enrolled patients for whom Anagrelide Hydrochloride therapy was initiated. Subjects who had not taken any previous cytoreductive therapy other than Anagrelide Hydrochloride were excluded from the FAS.||percentage of subjects||95% Confidence Interval|Number
825670|NCT01192347|Primary|Percentage of Subjects Achieving Platelet Target Response: No Withdrawal of Previous Cytoreductive Therapy|"Full response is a platelet count of <400x10^9/L. Partial response is a platelet count between 400-600x10^9/L or a platelet count reduction of 200x10^9.
Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables:
•Withdrawal of previous cytoreductive therapy:
Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation
After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up
Not Withdrawn: in all other cases"|6 months|Full Analysis Set (FAS) comprised all enrolled patients for whom Anagrelide Hydrochloride therapy was initiated. Subjects who had not taken any previous cytoreductive therapy other than Anagrelide Hydrochloride were excluded from the FAS.||percentage of subjects||95% Confidence Interval|Number
825671|NCT01192347|Primary|Percentage of Subjects Achieving Platelet Target Response: Withdrawal of Previous Cytoreductive Therapy After Anagrelide Hydrochloride Initiation|"Full response is a platelet count of <400x10^9/L. Partial response is a platelet count between 400-600x10^9/L or a platelet count reduction of 200x10^9.
Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables:
•Withdrawal of previous cytoreductive therapy:
Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation
After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up
Not Withdrawn: in all other cases"|6 months|Full Analysis Set (FAS) comprised all enrolled patients for whom Anagrelide Hydrochloride therapy was initiated. Subjects who had not taken any previous cytoreductive therapy other than Anagrelide Hydrochloride were excluded from the FAS.||percentage of subjects||95% Confidence Interval|Number
825672|NCT01192347|Primary|Percentage of Subjects Achieving Platelet Target Response: Withdrawal of Previous Cytoreductive Therapy Before Anagrelide Hydrochloride Initiation|"Full response is a platelet count of <400x10^9/L. Partial response is a platelet count between 400-600x10^9/L or a platelet count reduction of 200x10^9.
Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables:
•Withdrawal of previous cytoreductive therapy:
Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation
After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up
Not Withdrawn: in all other cases"|6 months|Full Analysis Set (FAS) comprised all enrolled patients for whom Anagrelide Hydrochloride therapy was initiated. Subjects who had not taken any previous cytoreductive therapy other than Anagrelide Hydrochloride were excluded from the FAS.||percentage of subjects||95% Confidence Interval|Number
825686|NCT01192516|Primary|Pain- WOMAC|This is a 5-item pain scale in which scores from 0 - 4 are summed. A higher score indicates more pain.|10 weeks post-baseline|Sample numbers may differ due to missing data||units on a scale||Standard Deviation|Mean
825687|NCT01192516|Primary|Pain- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)|This is a summary of reported pain in specific activities. It is 5 questions with answers ranging from 0 - 4. Total possible score is 20 in which a higher score is worse pain.|Baseline|||units on a scale||Standard Deviation|Mean
825673|NCT01192347|Primary|Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: When the Dosing Was Inconsistent With the Summary of Product Characteristics (SmPC)|"Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when XAGRID treatment was initiated, using the following variables:
Initiation of XAGRID dosing consistent with the Summary of Product Characteristics (SmPC):
Consistent if:
The starting dose was <=1 mg/day, AND
Any increase in dose was no more than 0.5mg/day, AND
Any increase in dose was made at least 7 days after first initiation or at least 7 days after any previous modification (up or down), AND
The maximum dose did not exceed 10 mg/day at any stage.
Inconsistent: in all other cases"|6 months|Full Analysis Set (FAS) comprised all enrolled patients for whom Anagrelide Hydrochloride therapy was initiated. Subjects who had not taken any previous cytoreductive therapy other than Anagrelide Hydrochloride were excluded from the FAS.||percentage of subjects||95% Confidence Interval|Number
825674|NCT01192347|Primary|Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: When the Dosing Was Consistent With the Summary of Product Characteristics (SmPC)|"Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when XAGRID treatment was initiated, using the following variables:
Initiation of XAGRID dosing consistent with the Summary of Product Characteristics (SmPC):
Consistent if:
The starting dose was <=1 mg/day, AND
Any increase in dose was no more than 0.5mg/day, AND
Any increase in dose was made at least 7 days after first initiation or at least 7 days after any previous modification (up or down), AND
The maximum dose did not exceed 10 mg/day at any stage.
Inconsistent: in all other cases"|6 months|Full Analysis Set (FAS) comprised all enrolled patients for whom Anagrelide Hydrochloride therapy was initiated. Subjects who had not taken any previous cytoreductive therapy other than Anagrelide Hydrochloride were excluded from the FAS.||percentage of subjects||95% Confidence Interval|Number
825675|NCT01192347|Primary|Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: No Withdrawal of Previous Cytoreductive Therapy|"Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables:
•Withdrawal of previous cytoreductive therapy:
Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation
After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up
Not Withdrawn: in all other cases"|6 months|Full Analysis Set (FAS) comprised all enrolled patients for whom Anagrelide Hydrochloride therapy was initiated. Subjects who had not taken any previous cytoreductive therapy other than Anagrelide Hydrochloride were excluded from the FAS.||percentage of subjects||95% Confidence Interval|Number
825676|NCT01192347|Secondary|Number of Subjects With Anagrelide Hydrochloride Titration Modifcations- First Modification Only||6 months|Safety Set comprised all subjects who had taken at least 1 dose of Anagrelide Hydrochloride and had at least 1 post-baseline safety assessment documented.||participants|||Number
825677|NCT01192347|Secondary|Percentage of Subjects With Anagrelide Hydrochloride Starting Doses||6 months|Safety Set comprised all subjects who had taken at least 1 dose of Anagrelide Hydrochloride and had at least 1 post-baseline safety assessment documented.||percentage of subjects|||Number
825678|NCT01192347|Primary|Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: Withdrawal of Previous Cytoreductive Therapy After Anagrelide Hydrochloride Initiation|"Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables:
•Withdrawal of previous cytoreductive therapy:
Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation
After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up
Not Withdrawn: in all other cases"|6 months|Full Analysis Set (FAS) comprised all enrolled patients for whom Anagrelide Hydrochloride therapy was initiated. Subjects who had not taken any previous cytoreductive therapy other than Anagrelide Hydrochloride were excluded from the FAS.||percentage of subjects||95% Confidence Interval|Number
825679|NCT01192347|Primary|Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: Withdrawal of Previous Cytoreductive Therapy Before Anagrelide Hydrochloride Initiation|"Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables:
•Withdrawal of previous cytoreductive therapy:
Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation
After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up
Not Withdrawn: in all other cases"|6 months|Full Analysis Set (FAS) comprised all enrolled patients for whom Anagrelide Hydrochloride therapy was initiated. Subjects who had not taken any previous cytoreductive therapy other than Anagrelide Hydrochloride were excluded from the FAS.||percentage of subjects||95% Confidence Interval|Number
825680|NCT01192412|Secondary|Serious Maternal Complications Measured up to 6 Weeks Postpartum|"Serious maternal complications measured up to 6 weeks postpartum. Death or one or more life-threatening maternal complications:
Adverse neurological complications (stroke, eclampsia, and/or blindness), and/or
End-organ failure (uncontrolled hypertension, inotropic support, pulmonary oedema, respiratory failure, myocardial ischaemia/infarction, renal failure, coagulopathy, and/or transfusion)"|6 weeks|||participants|||Number
825681|NCT01192412|Primary|Pregnancy Loss or NICU Admission for Greater Than 48 Hours|Pregnancy loss or NICU admission for greater than 48 hours, as recorded in the maternal and infant medical records immediately following the birth (or pregnancy loss), and then again after the mothers' and infants' discharge home. Supplemental information, about potential post-discharge maternal or neonatal morbidities in the 6 weeks following birth for the mother, or 28 days of life for the baby, will be obtained by contacting women at 6 weeks postpartum and/or from medical records.|6 weeks|||participants|||Number
825682|NCT01192516|Secondary|Physical Function- Six Minute Walk|This is the distance people walk in feet over 6 minutes|6 months post baseline|Numbers may differ due to missing data||feet||Standard Deviation|Mean
825683|NCT01192516|Secondary|Physical Function- Six Minute Walk|This is the distance in feet that people walk over 6 minutes.|10 weeks post-baseline|Numbers may differ due to missing data||feet||Standard Deviation|Mean
825688|NCT01192516|Primary|Fatigue-BFI|This is a summary measure of fatigue severity and interference items in which the average of 9 items is taken. Each item is rated on a scale of 0 - 10. A higher score indicates worse fatigue.|6 months post-baseline|Sample numbers may vary due to missing data||units on a scale||Standard Deviation|Mean
825689|NCT01192516|Primary|Fatigue-BFI|This is a summary measure of fatigue severity and interference items in which the average of 9 items is taken. Each item is rated on a scale of 0 - 10. A higher score is worse fatigue.|10 weeks post-baseline|Sample numbers may differ due to missing data||units on a scale||Standard Deviation|Mean
825690|NCT01192516|Primary|Fatigue- Brief Fatigue Inventory (BFI)|This is a summary measure of fatigue severity and fatigue interference items in which the average of 9 items is taken. Each item is rated on a scale of 0 - 10. A higher score is worse fatigue.|Baseline|||units on a scale||Standard Deviation|Mean
825691|NCT01192542|Primary|Binocular Visual Acuity|Snellen binocular visual acuity assessed by the Investigator and was converted to the LogMAR scale. A value <0 implies clinically positive results, a value >0 implies clinically negative results|Post lens insertion (baseline)|Analysis was conducted on subjects who enrolled, were randomized, and successfully complete the study per protocol.||LogMAR||Standard Error|Least Squares Mean
825692|NCT01192542|Secondary|Bulbar Redness of Grade 3 or Above|Bulbar redness was assessed using a 5-point slit lamp classification scale (5-Worst, 0-None). Only those eyes with bulbar redness grade >= 3 were reported for purposes of this analysis. Grades 3 -5 are considered to be part of the adverse events reporting.|After 6-8 days of lens wear|Analysis was conducted on subjects who successfully completed the study.||Subject Eyes|Participants||Number
825693|NCT01192542|Secondary|Limbal Redness of Grade 3 or Above|Limbal redness was assessed using a 5-point slit lamp classification scale (5-Worst, 0-None). Only those eyes with limbal redness grade >= 3 were reported for purposes of this analysis. Grades 3 -5 are considered to be part of the adverse events reporting.|After 6-8 days of lens wear|Analysis was conducted on subjects who successfully completed the study.||Subject Eyes|Participants||Number
825694|NCT01192542|Primary|Monocular Visual Acuity Assessment|Snellen monocular visual acutity (VA) assessed by the Investigator and was converted to the LogMAR scale.|Post lens insertion (baseline)|Analysis was conducted on subjects who were enrolled, randomized, and successfully completed the study.||logMAR|Participants|Standard Error|Least Squares Mean
825695|NCT01192698|Primary|HCV RNA Result|Will measure mean HCV RNA levels 4 weeks after liver transplant|4 weeks after liver transplant|||IU/ml||Standard Deviation|Mean
825696|NCT01185028|Primary|Number of Participants With Adverse Events|Adverse events determined and evaluated by patient reporting and the DAIDS toxicity table.|2 years|||adverse events|||Number
825697|NCT01185028|Secondary|Tolerability|Proportion of individuals that discontinued study drug|2 years||||||
825698|NCT01185028|Secondary|Sustained Viral Response Rate|Proportion of participants that are HCV negative 6 months after treatment completion|72 weeks|||participants|||Number
825699|NCT01185080|Secondary|Change From Baseline of C-X-C Motif Chemokine 10 (CXCL10) in Nasal Lavage|"Change from baseline to 24 hours after last dose (day1 visit 15) of C-X-C motif chemokine 10 (CXCL10) in nasal lavage, expressed as a ratio. The ratio is calculated as day1 of visit 15 / baseline.
Number of Participants Analyzed is based on all patients with evaluable biomarker data at visit 2 and visit 15."|Baseline to 1st day of visit 15|||ratio||95% Confidence Interval|Least Squares Mean
825700|NCT01185080|Secondary|Change From Baseline of C-X-C Motif Chemokine 10 (CXCL10) in Plasma|"Change from baseline to 24 hours after last dose (day1 visit 15) of C-X-C motif chemokine 10 (CXCL10) in plasma, expressed as a ratio. The ratio is calculated as day1 of visit 15 / baseline.
Number of Participants Analyzed is based on all patients with evaluable biomarker data at visit 2 and visit15."|Baseline to 1st day of visit 15|||ratio||95% Confidence Interval|Geometric Mean
825701|NCT01185080|Secondary|Absolute Mean Value of Peak Nasal Inspiratory Flow (PNIF)|"Absolute mean value of Peak Nasal Inspiratory Flow (PNIF) for pre-dose symptoms on visit 11, during treatment period. Treatment period is one month, which starts at visit 2 and ends at visit 14. The patient will breathe out as much as he can. Then a mask (Portable Inspiratory Flow Meter) will be placed over the nose and mouth and the patient will inspire forcefully through the nose while the lips remain tightly closed. The highest PNIF (L/minute) out of 3 measurements will be recorded.
Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data at visit 11."|Pre-dose on visit 11 (end of 3rd week of treatment)|||L/min||Standard Deviation|Mean
825702|NCT01185080|Secondary|Absolute Mean Value of Peak Nasal Inspiratory Flow (PNIF)|"Absolute mean value of Peak Nasal Inspiratory Flow (PNIF) for pre-dose symptoms on visit 2, during treatment period. Treatment period is one month, which starts at visit 2 and ends at visit 14. The patient will breathe out as much as he can. Then a mask (Portable Inspiratory Flow Meter) will be placed over the nose and mouth and the patient will inspire forcefully through the nose while the lips remain tightly closed. The highest PNIF (L/minute) out of 3 measurements will be recorded.
Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data at visit 2."|Pre-dose on visit 2 (baseline)|||L/min||Standard Deviation|Mean
825703|NCT01185080|Secondary|Absolute Mean Value of Instantaneous Total Nasal Symptom Score (TNSS)|"Absolute mean value of Instantaneous Total Nasal Symptom Score (TNSS) for pre-dose symptoms on visit11, during treatment period. Treatment period is one month, which starts at visit 2 and ends at visit 14. Each individual symptom is scored 0 to 3, which 0 = Absence of symptoms, 1 = Mild symptoms, 2 = Moderate symptoms and 3 = Severe symptoms. The scores of each individual symptom (runny nose, blocked nose and the maximum score of nasal itching or sneezing) will be added together to give a TNSS of 0 to 9. TNSS Score 0 indicates better outcome and TNSS score 9 indicates worse outcome.
Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data at visit 11."|Pre-dose on visit 11 (end of 3rd week of treatment)|||Scores on a scale||Standard Deviation|Mean
825704|NCT01185080|Secondary|Absolute Mean Value of Instantaneous Total Nasal Symptom Score (TNSS)|"Absolute mean value of Instantaneous Total Nasal Symptom Score (TNSS) for pre-dose symptoms on visit 2, during treatment period. Treatment period is one month, which starts at visit 2 and ends at visit 14. Each individual symptom is scored 0 to 3, which 0 = Absence of symptoms, 1 = Mild symptoms, 2 = Moderate symptoms and 3 = Severe symptoms. The scores of each individual symptom (runny nose, blocked nose and the maximum score of nasal itching or sneezing) will be added together to give a TNSS of 0 to 9. TNSS Score 0 indicates better outcome and TNSS score 9 indicate worse outcome.
Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data at visit 2."|Pre-dose on visit 2 (baseline)|||Scores on a scale||Standard Deviation|Mean
825705|NCT01185080|Primary|of Evening Measurements of Peak Nasal Inspiratory Flow (PNIF) (12 Hrs)|"Mean of evening measurements of Peak Nasal Inspiratory Flow (absolute values) of symptoms over the last 12 hours during allergen challenge, collected in patient diary. The Mean is calculated over the evening of the 1st day to the morning of 8th day of the Allergen challenge period. The patient will breathe out as much as he can. Then a mask (Portable Inspiratory Flow Meter) will be placed over the nose and mouth and the patient will inspire forcefully through the nose while the lips remain tightly closed. The highest PNIF (L/minute) out of 3 measurements will be recorded.
Allergen challenge period starts 24 hrs post last dose. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15)."|During evening of the 1st day to the morning of the 8th day of Allergen challenge period.|||L/min||Full Range|Least Squares Mean
825706|NCT01185080|Primary|Mean of Morning Measurements of Peak Nasal Inspiratory Flow (PNIF) (12 Hrs)|"Mean of morning measurements of Peak Nasal Inspiratory Flow (absolute values) of symptoms over the last 12 hours during allergen challenge, collected in patient diary. The Mean is calculated over the evening of the 1st day to the morning of 8th day of the Allergen challenge period. The patient will breathe out as much as he can. Then a mask (Portable Inspiratory Flow Meter) will be placed over the nose and mouth and the patient will inspire forcefully through the nose while the lips remain tightly closed. The highest PNIF (L/minute) out of 3 measurements will be recorded.
Allergen challenge period starts 24 hrs post last dose. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15)."|During evening of the 1st day to the morning of the 8th day of Allergen challenge period.|||L/min||Full Range|Least Squares Mean
825707|NCT01185080|Primary|Mean of Peak Nasal Inspiratory Flow (PNIF) (10 Min)|"Mean of Peak Nasal Inspiratory Flow (absolute values) recorded immediately after TNSS scoring (recall period 10 min), during Allergen challenge period. The Mean is calculated over 4th day to 7th day of the Allergen challenge period. The patient will breathe out as much as he can. Then a mask (Portable Inspiratory Flow Meter) will be placed over the nose and mouth and the patient will inspire forcefully through the nose while the lips remain tightly closed. The highest PNIF (L/minute) out of 3 measurements will be recorded.
Allergen challenge period starts 24 hrs post last dose. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15)."|During 4th day to 7th day of Allergen challenge period.|||L/min||Full Range|Least Squares Mean
825708|NCT01185080|Primary|Mean of Peak Nasal Inspiratory Flow (PNIF) (10 Min)|"Mean of Peak Nasal Inspiratory Flow (absolute values) recorded immediately after TNSS scoring (recall period 10 min), during Allergen challenge period. The Mean is calculated over the Allergen challenge period, which is a seven day period. The patient will breathe out as much as he can. Then a mask (Portable Inspiratory Flow Meter) will be placed over the nose and mouth and the patient will inspire forcefully through the nose while the lips remain tightly closed. The highest PNIF (L/minute) out of 3 measurements will be recorded.
Allergen challenge period starts 24 hrs post last dose. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15)."|During 1st day to 7th day of Allergen challenge period.|||L/min||Full Range|Least Squares Mean
825709|NCT01185080|Primary|Mean of Evening Measurements of Reflective (12 Hrs) Total Nasal Symptom Score (TNSS)|"Mean of evening measurements of Reflective Total Nasal Symptom Score (absolute values) of symptoms over the last 12 hours during allergen challenge, collected in patient diary. The Mean is calculated over the evening of the 1st day to the morning of 8th day of the Allergen challenge period. Each individual symptom is scored 0 to 3, which 0 = Absence of symptoms, 1 = Mild symptoms, 2 = Moderate symptoms and 3 = Severe symptoms. The scores of each individual symptom (runny nose, blocked nose and the maximum score of nasal itching or sneezing) will be added together to give a TNSS of 0 to 9. TNSS Score 0 indicates better outcome and TNSS score 9 indicates worse outcome.
Allergen challenge period starts 24 hrs post last dose. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15)."|During the evening of the 1st day to the morning of the 8th day of Allergen challenge period.|||Scores on a scale||Full Range|Least Squares Mean
825710|NCT01185080|Primary|Mean of Morning Measurements of Reflective (12 Hrs) Total Nasal Symptom Score (TNSS)|"Mean of morning measurements of Reflective Total Nasal Symptom Score (absolute values) of symptoms over the last 12 hours during allergen challenge, collected in patient diary. The Mean is calculated over the evening of the 1st day to the morning of 8th day of the Allergen challenge period. Each individual symptom is scored 0 to 3, which 0 = Absence of symptoms, 1 = Mild symptoms, 2 = Moderate symptoms and 3 = Severe symptoms. The scores of each individual symptom (runny nose, blocked nose and the maximum score of nasal itching or sneezing) will be added together to give a TNSS of 0 to 9. TNSS Score 0 indicates better outcome and TNSS score 9 indicates worse outcome.
Allergen challenge period starts 24 hrs post last dose. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15)."|During evening of the 1st day to the morning of the 8th day of Allergen challenge period.|||Scores on a scale||Full Range|Least Squares Mean
825711|NCT01185080|Primary|Mean of Reflective (10 Min) Total Nasal Symptom Score (TNSS)|"Mean of Reflective Total Nasal Symptom Score (absolute values) for symptoms over the last 10 minutes after allergen challenge, collected during clinic visits. The Mean is calculated over 4th day to 7th day of the Allergen challenge period. Each individual symptom is scored 0 to 3, which 0 = Absence of symptoms, 1 = Mild symptoms, 2 = Moderate symptoms and 3 = Severe symptoms. The scores of each individual symptom (runny nose, blocked nose and the maximum score of nasal itching or sneezing) will be added together to give a TNSS of 0 to 9. TNSS Score 0 indicates better outcome and TNSS score 9 indicates worse outcome. Allergen challenge period starts 24 hrs post last dose.
Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15)."|During 4th day to 7th day of Allergen challenge period.|||Scores on a scale||Full Range|Least Squares Mean
825795|NCT01185561|Secondary|State–Trait Anxiety Inventory (STAI Form Y-1) Trait Anxiety Sub-test Score|Scores on the The State–Trait Anxiety Inventory (STAI Form Y-1) Trait Anxiety Sub-test are compared between those assigned to intervention versus those assigned to usual medical care six months after randomization. The STAI trait anxiety subtest is a 20-item scale measuring state anxiety. Scores may range from 20 to 80 with higher scores indicating greater state anxiety.|6 Months|This analysis is restricted to participants who completed the final study visit six months after randomization.||units on a scale||Standard Deviation|Mean
825712|NCT01185080|Primary|Mean of Reflective (10 Min) Total Nasal Symptom Score (TNSS)|"Mean of Reflective Total Nasal Symptom Score (absolute values) for symptoms over the last 10 minutes after allergen challenge, collected during clinic visits. The Mean is calculated over the Allergen challenge period, which is a seven day period. Each individual symptom is scored 0 to 3, which 0 = Absence of symptoms, 1 = Mild symptoms, 2 = Moderate symptoms and 3 = Severe symptoms. The scores of each individual symptom (runny nose, blocked nose and the maximum score of nasal itching or sneezing) will be added together to give a TNSS of 0 to 9. TNSS Score 0 indicates better outcome and TNSS score 9 indicates worse outcome.
Allergen challenge period starts 24 hrs post last dose (visit 15). Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15)."|During 1st day to 7th day of Allergen challenge period.|||Scores on a scale||Full Range|Least Squares Mean
825713|NCT01185249|Primary|The Measurement of the Difference Between Early Morning and Evening Weights for CHF Patients||Mean differences in the morning (5am) weights compared for three consecutive days. Day 1, Day 2, Day 3. Mean difference in the morning (5am) and evening (8pm) weights for three consecutive days. Day 1, Day 2, Day 3.|Patients with three consecutive days of morning and evening weights.||kilograms||Standard Deviation|Mean
825714|NCT01185288|Other Pre-specified|Serum Adalimumab Trough Concentrations at Week 24|Serum trough concentrations of adalimumab assessed at week 24 (24 weeks after the 1st dose).|Week 24|All participants with available pharmacokinetics at week 24: For Adalimumab + Low Dose Methotrexate, n = 134; for Adalimumab + High Dose Methotrexate, n = 140.||µg/mL||Standard Deviation|Mean
825715|NCT01185288|Secondary|Percent Change From Baseline in Medical Outcomes Study Version II (MOS) Sleep Problem Index 9 at Week 24|The least squares mean percentage change in MOS Sleep Problem Index 9 from baseline to week 24. The MOS Sleep Problem Index 9 consists of 9 questions to assess sleep, including how long it takes the participant to fall asleep (1=0 to 15 minutes, to 5=more than 60 minutes); and aspects of related to quality of sleep, including how often the participant felt that the sleep was not quiet, felt rested upon waking, awakened short of breath or with a headache, felt drowsy during the day, had trouble falling sleep, how often were awaken, had trouble staying awake during the day, and got needed amount of sleep (1=all the time; 5=none of the time). Least squares means and 95% CI were from 2-way ANCOVA model with effects for baseline MOS Sleep Problem Index value, treatment group, and prior methotrexate dose group.|Baseline, 24 weeks|All participants who were randomized and received at least one dose of study medication (intent to treat). Missing responses were imputed by carrying forward the value at early termination visit (LOCF).||percent change||95% Confidence Interval|Least Squares Mean
825716|NCT01185288|Secondary|Percentage of Participants With a Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) ≤ -0.22 at Week 24|The HAQ-DI is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0), with some difficulty (1), with much difficulty (2), and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 (no disability) to 3 (very severe, high dependency disability). The minimal clinically important difference (MCID) defined for the HAQ-DI is a change from baseline of ≤ -0.22. Normal physical function is defined by HAQ-DI score of < 0.5. Negative change from baseline in the overall score indicates improvement.|Baseline, 24 weeks|All participants who were randomized and received at least one dose of study medication (intent to treat). Missing responses were imputed by carrying forward the value at early termination visit (LOCF).||percentage of participants|||Number
825717|NCT01185288|Secondary|Percentage of Participants With American College of Rheumatology 70% (ACR70) Criteria Response at Week 24|Response, as defined by ACR70 criteria at week 24. A participant is a responder if the following 3 criteria for improvement from baseline are met: ≥ 70% improvement in tender joint count; ≥ 70% improvement in swollen joint count; and ≥ 70% improvement in at least 3 of the 5 following parameters: physician global assessment of disease activity, participant global assessment of disease activity, participant assessment of pain, disability index of the health assessment questionnaire, and acute phase reactant value (C-reactive protein).|Baseline, 24 weeks|All participants who were randomized and received at least one dose of study medication (intent to treat). Missing responses were imputed by carrying forward the value at early termination visit (LOCF).||percentage of participants|||Number
825718|NCT01185288|Secondary|Percentage of Participants With American College of Rheumatology 50% (ACR50) Criteria Response at Week 24|Response, as defined by ACR50 criteria at week 24. A participant is a responder if the following 3 criteria for improvement from baseline are met: ≥ 50% improvement in tender joint count; ≥ 50% improvement in swollen joint count; and ≥ 50% improvement in at least 3 of the 5 following parameters: physician global assessment of disease activity, participant global assessment of disease activity, participant assessment of pain, disability index of the health assessment questionnaire, and acute phase reactant value (C-reactive protein).|Baseline, 24 weeks|All participants who were randomized and received at least one dose of study medication (intent to treat). Missing responses were imputed by carrying forward the value at early termination visit (LOCF).||percentage of participants|||Number
825719|NCT01185288|Secondary|Percentage of Participants With Power Doppler Ultrasound (PD U/S) Score for Synovial Vascularity Improvement by 30% at Week 24|PD U/S assessed the severity of synovial inflammation in both hands (bilateral wrists, metacarpophalangeal joints 2, 3, 5, and metatarsophalangeal joint 5). Bilateral images based on dorsal midline imaging of the wrist, dorsal and volar imaging of metacarpophalangeal joints, and dorsal imaging alone of metatarsophalangeal joints are scored using a 4-grade scale: grade 0 or normal = normal joint (no Doppler signal); grade 1 or mild = mild synovitis (≤ 3 isolated signals); grade 2 or moderate = moderate synovitis (> 3 isolated signals or a confluent signal in < 50% of synovial area); grade 3 or marked = marked synovitis (signals in ≥ 50% of the synovial area). Each image is rated 0 to 3, for a total possible score ranging from 0 to 48 (16*0, 16*3) for 2 hands. Higher grade/score=more severe disease. Change = week 24 score - baseline score.|Baseline, 24 weeks|All participants who were randomized and received at least one dose of study medication (intent to treat). Missing responses were imputed by carrying forward the value at early termination visit (LOCF).||percentage of participants|||Number
826212|NCT01188655|Secondary|Percentage of Participants Without Enthesitis||Week 12 and Week 24|Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point.||Percentage of Participants|||Number
825720|NCT01185288|Primary|Disease Activity Score for 28 Joints Based on C-reactive Protein (DAS28[CRP]) at Week 24|The DAS28(CRP) score includes 28 tender joint counts, 28 swollen joint counts, C-reactive protein, and participant's global assessment of disease activity. Scores on the DAS28(CRP) range from 0 to 10. A DAS28(CRP) score ≥ 5.1 indicates high disease activity, and a DAS28(CRP) score < 2.6 indicates clinical remission. Least squares means and 95% CI were from 2-way ANCOVA model with effects for baseline DAS28(CRP) value, treatment group, and prior methotrexate dose group.|Week 24|All participants who were randomized and received at least one dose of study medication (intent to treat). Missing responses were imputed using last observation carried forward (LOCF).||scores on a scale||95% Confidence Interval|Least Squares Mean
825721|NCT01185301|Secondary|Percentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Week 26|CDAI is a measure of disease activity derived as follows: CDAI = SJC28 + TJC28 + GH (cm) + PhGA (cm) where TJC28 and SJC28 represent total tender joint count and total swollen joint count, respectively, based on 28 joints (including the left and right side of the body), GH = Patient's Global Assessment of Disease Activity, and PhGA = Physician's Global Assessment of Disease Activity (both measured on a visual analogue scale with a range of 0 [none] to 10 [severe]). CDAI total score = 0 to 76. CDAI ≤ 2.8 indicates disease remission, > 2.8 to 10 = low disease activity, > 10 to 22 = moderate disease activity, and > 22 = high disease activity.|Week 26|Intent-to-Treat population; participants with a missing response were imputed as non-responders.||percentage of participants|||Number
825722|NCT01185301|Secondary|Percentage of Participants With Simplified Disease Activity Index (SDAI) Remission at Week 26|SDAI is a measure of disease activity derived as follows: SDAI = SJC28 + TJC28 + GH (cm) + PhGA (cm) + CRP (mg/dL), where TJC28 and SJC28 represent total tender joint count and total swollen joint count, respectively, based on 28 joints (including the left and right side of the body), GH = Patient's Global Assessment of Disease Activity, and PhGA = Physician's Global Assessment of Disease Activity (both measured on a visual analogue scale with a range of 0 [none] to 10 [severe]), and CRP is C-reactive protein measured in mg/dL. SDAI total score = 0 to 86. SDAI ≤ 3.3 indicates disease remission, > 3.4 to 11 = low disease activity, > 11 to 26 = moderate disease activity, and > 26 = high disease activity.|Week 26|Intent-to-Treat population; participants with a missing response were imputed as non-responders.||percentage of participants|||Number
825723|NCT01185301|Secondary|Percentage of Participants With No Radiographic Progression at Week 26|“No radiographic progression” was defined as a change from Baseline in modified Total Sharp Score (mTSS) at Week 26 of ≤ 0.5. mTSS is a measure of change in joint health from digitized images of radiographs of hands and feet. Joints were scored for erosions on a scale of 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale of 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.|Baseline, Week 26|Intent-to-Treat population; participants with a missing response were imputed as non-responders.||percentage of participants|||Number
825724|NCT01185301|Secondary|Change From Baseline in Modified Total Sharp Score (mTSS) at Week 26|The modified Total Sharp Score (mTSS) is a measure of change in joint health from digitized images of radiographs of hands and feet. Joints were scored for erosions on a scale of 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale of 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.|Baseline, Week 26|Intent-to-Treat population with available data at time point (observed cases).||score on a scale||Standard Deviation|Mean
825725|NCT01185301|Secondary|Percentage of Participants With a Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) ≤ –0.22 at Week 26|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. The minimal clinically important difference (MCID) defined for the HAQ-DI is a change from Baseline of ≥ 0.22. HAQ remission indicating normal physical function is defined by HAQ-DI score of < 0.5. Negative change from Baseline in the overall score indicates improvement.|Baseline, Week 26|Intent-to-Treat population; participants with a missing response were imputed as non-responders.||percentage of participants|||Number
825726|NCT01185301|Secondary|Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 26|The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability. HAQ remission indicating normal physical function is defined by HAQ-DI score of < 0.5. Negative change from Baseline in the overall score indicates improvement.|Baseline, Week 26|Intent-to-Treat population with non-missing baseline and at least 1 non-missing post-baseline value (baseline is defined as the last non-missing value prior to the first dose of study drug); last observation carried forward.||units on a scale||Standard Deviation|Mean
825727|NCT01185301|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 100 Criteria Response at Week 26|"Response, as defined by ACR 100 criteria at Week 26. A participant is a responder if the following 3 criteria for improvement from Baseline are met: ≥ 100% improvement in tender joint count; ≥ 100% improvement in swollen joint count; and ≥ 100% improvement in at least 3 of the 5 following parameters:
Physician global assessment of disease activity
Patient global assessment of disease activity
Patient assessment of pain
Disability Index of the Health Assessment Questionnaire
Acute phase reactant value (C-reactive protein)."|Baseline, Week 26|Intent-to-Treat population; participants with a missing response were imputed as non-responders.||percentage of participants|||Number
825728|NCT01185301|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 90 Criteria Response at Week 26|"Response, as defined by ACR 90 criteria at Week 26. A participant is a responder if the following 3 criteria for improvement from Baseline are met: ≥ 90% improvement in tender joint count; ≥ 90% improvement in swollen joint count; and ≥ 90% improvement in at least 3 of the 5 following parameters:
Physician global assessment of disease activity
Patient global assessment of disease activity
Patient assessment of pain
Disability Index of the Health Assessment Questionnaire
Acute phase reactant value (C-reactive protein)."|Baseline, Week 26|Intent-to-Treat population; participants with a missing response were imputed as non-responders.||percentage of participants|||Number
825729|NCT01185301|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 70 Criteria Response at Week 26|"Response, as defined by ACR 70 criteria at Week 26. A participant is a responder if the following 3 criteria for improvement from Baseline are met: ≥ 70% improvement in tender joint count; ≥ 70% improvement in swollen joint count; and ≥ 70% improvement in at least 3 of the 5 following parameters:
Physician global assessment of disease activity
Patient global assessment of disease activity
Patient assessment of pain
Disability Index of the Health Assessment Questionnaire
Acute phase reactant value (C-reactive protein)."|Baseline, Week 26|Intent-to-Treat population; participants with a missing response were imputed as non-responders.||percentage of participants|||Number
825730|NCT01185301|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 50 Criteria Response at Week 26|"Response, as defined by ACR 50 criteria at Week 26. A participant is a responder if the following 3 criteria for improvement from Baseline are met: ≥ 50% improvement in tender joint count; ≥ 50% improvement in swollen joint count; and ≥ 50% improvement in at least 3 of the 5 following parameters:
Physician global assessment of disease activity
Patient global assessment of disease activity
Patient assessment of pain
Disability Index of the Health Assessment Questionnaire
Acute phase reactant value (C-reactive protein)."|Baseline, Week 26|Intent-to-Treat population; participants with a missing response were imputed as non-responders.||percentage of participants|||Number
825731|NCT01185301|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 20 Criteria Response at Week 26|"Response, as defined by ACR 20 criteria at Week 26. A participant is a responder if the following 3 criteria for improvement from Baseline are met: ≥ 20% improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of the 5 following parameters:
Physician global assessment of disease activity
Patient global assessment of disease activity
Patient assessment of pain
Disability Index of the Health Assessment Questionnaire
Acute phase reactant value (C-reactive protein)."|Baseline, Week 26|Intent-to-Treat population; participants with a missing response were imputed as non-responders.||percentage of participants|||Number
825732|NCT01185301|Secondary|Percentage of Participants With DAS28(CRP) Remission at Week 26|Disease remission was defined as a disease activity score, based on CRP, for 28 joints that was < 2.6 (DAS28[CRP] < 2.6). The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10.|Week 26|Intent-to-Treat population; participants with a missing response were imputed as non-responders.||percentage of participants|||Number
825733|NCT01185301|Primary|Percentage of Participants With 28-Joint Disease Activity Score of C-reactive Protein (DAS28[CRP]) Low Disease Activity at Week 26|Percentage of participants achieving low disease activity as defined by a clinical response (DAS28[CRP] < 3.2). The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.|Week 26|Intent-to-Treat population; participants with a missing response were imputed as non-responders.||percentage of participants|||Number
825734|NCT01185353|Secondary|Mean Change From Baseline Through Week 12 in the ENSEMBLE Minimum Data Set 1.0||Baseline, 12 weeks|Zero participants were analyzed. Assessment of ENSEMBLE Minimum Data Set 1.0 was not collected at Week 12 and therefore results are not reported for outcome measure.|||||
825735|NCT01185353|Secondary|Population PK: Area Under the Concentration Curve Versus Time at a Dosing Interval at Steady State (AUCtau,ss) of LY3009104||Baseline through 24 weeks|All randomized participants who received at least 1 dose of LY3009104 with evaluable LY3009104 PK data.||nanomoles*hour/Liter (nmol*h/L)||Geometric Coefficient of Variation|Geometric Mean
825736|NCT01185353|Secondary|Population Pharmacokinetics (PK): Maximum Concentration at Steady State of Dosing (Cmax,ss) of LY3009104||Baseline through 24 weeks|All randomized participants who received at least 1 dose of LY3009104 with evaluable LY3009104 PK data.||nanomoles/Liter (nmol/L)||Geometric Coefficient of Variation|Geometric Mean
825737|NCT01185353|Secondary|Mean Change From Baseline to Week 12 in Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F) Score|The FACIT-F Scale is a brief 13-item, symptom-specific questionnaire that specifically assesses the participant self-reported severity of fatigue and its impact upon daily activities and functioning. The FACIT-F uses a numeric rating scale of 0 (“Not at all”) to 4 (“Very much”) for each item to assess fatigue and its impact in the past 7 days. Total scores range from 0 to 52, with higher scores indicating less fatigue.|Baseline, Week 12|All randomized participants who received study drug in Part A and had FACIT-F evaluated at Week 12. LOCF was used to impute missing post-baseline values.||units on a scale||Standard Deviation|Mean
825738|NCT01185353|Secondary|Mean Change From Baseline to Week 12 in Brief Pain Inventory Modified Short Form (BPI-sf Modified) Worst-Pain-in-the Past-24-hours Item Score|The BPI-sf modified is a self-administered questionnaire developed for the rapid assessment of pain. The BPI-sf modified provides information on the intensity of pain (the sensory dimension) as well as the degree to which pain interferes with function (the reactive dimension). The questionnaire asks questions about pain relief, pain quality, and the participant's perception of the cause of pain. The BPI-sf modified uses a numeric rating scale from 0 (“No pain”) to 10 (“Pain as bad as you can imagine”). Since pain can be quite variable over a day, the BPI-sf modified asked participants to rate their pain at the time of responding to the questionnaire (right now), and also at its worst, least and average over the last 24 hours.|Baseline, Week 12|All randomized participants who received study drug and had BPI-sf worst-pain-in-the past-24-hours item evaluated at Week 12. LOCF was used to impute missing post-baseline values.||units on a scale||Standard Deviation|Mean
825739|NCT01185353|Secondary|Mean Change From Baseline to Week 12 in Medical Outcomes Study 36-Item Short Form (SF-36) Health Survey Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores|The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains (physical functioning, bodily pain, role limitations due to physical problems and also emotional problems, general health, mental health, social functioning and vitality) and 2 component scores (PCS and MCS). The PCS score consisted of physical functioning, bodily pain, role-physical, and general health scales. The MCS score consisted of social functioning, vitality, mental health, and role-emotional scales. Both PCS and MCS range from 0-100 with higher scores indicating better health or functioning.|Baseline, Week 12|All randomized participants who received study drug in Part A and had SF-36 evaluated at analysis time point. LOCF was used to impute missing post-baseline values.||units on a scale||Standard Deviation|Mean
825740|NCT01185353|Secondary|Mean Change From Baseline Through Week 12 in Duration (Minutes) of Morning Stiffness|The Investigator asked participants about the duration of their morning stiffness (in minutes) in and around the joints and recorded the duration. The Investigator asked the participants about duration of morning stiffness on the day prior to the study visit to capture actual symptoms. If morning stiffness duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses.|Baseline, Weeks 4, 8, 12|All randomized participants who received study drug in Part A and had morning stiffness evaluated at analysis time points. LOCF was used to impute missing post-baseline values for Week 12 analysis.||minutes||Standard Deviation|Mean
825741|NCT01185353|Secondary|Percentage of Participants Meeting Low Disease Activity and Remission Based on the 28 Diarthrodial Joint Count (DAS28) Baseline Through Weeks 76 and 128|Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), CRP (mg/L), and Patient's Global Assessment of Disease Activity using VAS (patient's global VAS). Scores ranged from 1.0-9.4, where lower scores indicated less disease activity. DAS28 scores ≤3.2 are considered as low disease activity, and scores <2.6 are considered as remission. Participants who discontinue before analysis time points are treated as non-responders.|Baseline through Weeks 76 and 128|All participants who received study drug in Parts C and D and had DAS28-CRP evaluated at analysis time points.||percentage of participants|||Number
825742|NCT01185353|Secondary|Percentage of Participants Meeting Low Disease Activity and Remission Based on the 28 Diarthrodial Joint Count (DAS28) Baseline Through Weeks 12 and 24|Disease Activity Score (DAS) modified to include 28-joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), CRP [milligrams per liter (mg/L)], and Patient's Global Assessment of Disease Activity using VAS (patient's global VAS). Scores ranged from 1.0-9.4, where lower scores indicated less disease activity. DAS28 scores ≤3.2 are considered as low disease activity, and scores <2.6 are considered as remission. Participants who discontinue before analysis time points are treated as non-responders.|Baseline through Weeks 12 and 24|All randomized participants who received study drug in Parts A and B and had DAS28-CRP evaluated at analysis time points.||percentage of participants|||Number
825743|NCT01185353|Secondary|Percentage of Responders According to EULAR28 Baseline Through Weeks 76 and 128|EULAR28 categorizes clinical response based upon improvement since baseline in Disease Activity Score modified to include the 28-joint count (DAS28) and post-baseline DAS28. DAS28 consists of a composite score of the following variables: tender joint count (TJC28), swollen joint count (SJC28), CRP, and Patient's Global Assessment of their Disease Activity (patient's global VAS). DAS28 scores range from 1.0-9.4. EULAR28 categories include: No Response (improvement in DAS28 of ≤0.6 units or post-baseline DAS28 score >5.1 with improvement by ≤1.2 units), Moderate Response (post-baseline DAS28 ≤5.1 with improvement by >0.6 units but ≤1.2 units or post-baseline DAS28 score >3.2 with improvement by >1.2 units), and Good Response (post-baseline DAS28 score ≤3.2 with improvement by >1.2 units).|Baseline, Weeks 76 and 128|All participants who received study drug in Parts C and D and had EULAR28 evaluated at analysis time points. LOCF was used to impute missing post-baseline values.||percentage of participants|||Number
825744|NCT01185353|Secondary|Percentage of Responders According to European League Against Rheumatism Responder Index Based on 28-joint Count (EULAR28) Baseline Through Weeks 12 and 24|EULAR28 categorizes clinical response based upon improvement since baseline in DAS modified to include the 28-joint count (DAS28) and post-baseline DAS28. DAS28 consists of a composite score of the following variables: TJC28, SJC28, CRP, and Patient's Global Assessment of their Disease Activity (patient's global VAS). DAS28 scores range from 1.0-9.4. EULAR28 categories include: No Response (improvement in DAS28 of ≤0.6 units or post-baseline DAS28 score >5.1 with improvement by ≤1.2 units), Moderate Response (post-baseline DAS28 ≤5.1 with improvement by >0.6 units but ≤1.2 units or post-baseline DAS28 score >3.2 with improvement by >1.2 units), and Good Response (post-baseline DAS28 score ≤3.2 with improvement by >1.2 units).|Baseline through Weeks 12 and 24|All randomized participants who received study drug in Parts A and B and had EULAR28 evaluated at analysis time points.||percentage of participants|||Number
825745|NCT01185353|Secondary|Mean Change From Baseline to Weeks 76 and 128 in DAS28-CRP|Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), CRP (mg/L), and Patient's Global Assessment of Disease Activity using visual analog scale (VAS) (patient's global VAS). DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*patient's global VAS+0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity and remission is DAS28-CRP <2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition.|Baseline, Weeks 76 and 128|All participants who received study drug in Parts C and D and had DAS28-CRP evaluated at analysis time points. LOCF was used to impute missing post-baseline values.||units on a scale||Standard Deviation|Mean
825773|NCT01185522|Secondary|Number of Participants With Any Adverse Events and Serious Adverse Events|An Any Adverse Events (AEs) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An Serious Adverse Events (SAEs) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.|Up to 4 months|Safety population consisted of all participants included in the study, who respected the inclusion and non-inclusion criteria and who at least one tocilizumab infusion.||Number of Participants|||Number
825746|NCT01185353|Secondary|Mean Change From Baseline to Weeks 12 and 24 in Disease Activity Score (DAS) Based on the 28 Diarthrodial Joint Count and CRP Level (DAS28-CRP)|Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count-28 (TJC28), swollen joint count-28 (SJC28), CRP (mg/L), and Patient's Global Assessment of Disease Activity using VAS (patient's global VAS). DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*patient's global VAS+0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity, and remission was DAS28-CRP <2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition.|Baseline, Weeks 12 and 24|All randomized participants who received study drug in Parts A and B and had DAS28-CRP evaluated at analysis time points. LOCF was used to impute missing post-baseline values.||units on a scale||Standard Deviation|Mean
825747|NCT01185353|Secondary|Mean Change From Baseline to Weeks 76 and 128 in Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity and Patient's Assessment of Pain|Physician's and Patient's assessments of DA assessed using a VAS that ranged from 0 to 100 mm, where 0 indicated no arthritis activity and 100 indicated extremely active arthritis. Patient's assessment of pain due to arthritis assessed using a VAS that ranged from 0 (no pain) to 100 mm (worst possible pain).|Baseline, Weeks 76 and 128|All participants who received study drug in Parts C and D and had physician's and participant’s assessments of disease activity and pain evaluated at analysis time points. LOCF was used to impute missing post-baseline values.||units on a scale||Standard Deviation|Mean
825748|NCT01185353|Secondary|Mean Change From Baseline to Weeks 12 and 24 in Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity and Patient's Assessment of Pain|Physician's and Patient's Assessments of Disease Activity (DA) assessed using a visual analog scale (VAS) that ranged from 0 to 100 millimeters (mm), where 0 indicated no arthritis activity and 100 indicated extremely active arthritis. Patient's assessment of pain due to arthritis was also assessed using a VAS that ranged from 0 (no pain) to 100 mm (worst possible pain).|Baseline, Weeks 12 and 24|All randomized participants who received study drug in Parts A and B and had physician's and participant’s assessments of disease activity and participant’s pain evaluated at analysis time points. LOCF was used to impute missing post-baseline values.||units on a scale||Standard Deviation|Mean
825749|NCT01185353|Secondary|Mean Change From Baseline to Weeks 76 and 128 in ESR|ESR is a laboratory analyte that is an indicator of inflammation. Decreases represent reductions in inflammation.|Baseline, Weeks 76 and 128|All participants who received study drug in Parts C and D and had ESR evaluated at analysis time points. LOCF was used to impute missing post-baseline values.||mm/hr||Standard Deviation|Mean
825750|NCT01185353|Secondary|Mean Change From Baseline to Weeks 12 and 24 in Erythrocyte Sedimentation Rate (ESR)|ESR is a laboratory analyte that is an indicator of inflammation. Decreases represent reductions in inflammation.|Baseline, Weeks 12 and 24|All randomized participants who received study drug in Parts A and B and had ESR evaluated at analysis time points.||mm/hr||Standard Deviation|Mean
825751|NCT01185353|Secondary|Mean Change From Baseline to Weeks 76 and 128 in hsCRP|hsCRP is a laboratory analyte that is an indicator of inflammation. Decreases in hsCRP represent reductions in inflammation.|Baseline, Weeks 76 and 128|All participants who received study drug in Parts C and D and had hsCRP evaluated at analysis time points. LOCF was used to impute missing post-baseline values.||mg/L||Standard Deviation|Mean
825752|NCT01185353|Secondary|Mean Change From Baseline to Weeks 12 and 24 in High-Sensitivity C-Reactive Protein (hsCRP)|hsCRP is a laboratory analyte that is an indicator of inflammation. Decreases in hsCRP represent reductions in inflammation.|Baseline, Weeks 12 and 24|All randomized participants who received study drug in Parts A and B and had hsCRP evaluated at analysis time points. LOCF was used to impute missing post-baseline values.||mg/L||Standard Deviation|Mean
825753|NCT01185353|Secondary|Mean Change From Baseline to Weeks 76 and 128 in HAQ-DI Score|The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.|Baseline, Weeks 76 and 128|All participants who received study drug in Parts C and D and had HAQ-DI evaluated at analysis time points. LOCF was used to impute missing post-baseline values.||units on a scale||Standard Deviation|Mean
825754|NCT01185353|Secondary|Mean Change From Baseline to Weeks 12 and 24 in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score|The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.|Baseline, Weeks 12 and 24|All randomized participants who received study drug in Parts A and B and had HAQ-DI evaluated at analysis time points. LOCF was used to impute missing post-baseline values.||units on a scale||Standard Deviation|Mean
825755|NCT01185353|Secondary|Mean Change From Baseline to Weeks 76 and 128 in TJC and SJC|TJC is the number of tender and painful joints determined for each participant by examination of 68 joints. Joints were assessed by pressure and joint manipulation on physical examination. Participants were asked for pain sensations on these manipulations and watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-nontender dichotomy. SJC is the number of swollen joints determined for each participant by examination of 66 joints. Joints were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint.|Baseline, Weeks 76 and 128|All participants who received study drug in Parts C and D and had TJC and SJC evaluated at analysis time points. LOCF was used to impute missing post-baseline values.||units on a scale||Standard Deviation|Mean
825810|NCT01185704|Secondary|Number of Blastocysts|Blastocyst is an embryo, five or six days after fertilization, with an inner cell mass, outer layer of trophectoderm and a fluid-filled blastocoele cavity.|Day 5-6 post oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])|ITT population included all randomized participants who had received at least 1 dose of the study medication.||blastocysts||Standard Deviation|Mean
825756|NCT01185353|Secondary|Mean Change From Baseline to Weeks 12 and 24 in Tender and Swollen Joint Counts (TJC and SJC)|TJC is the number of tender and painful joints determined for each participant by examination of 68 joints. Joints were assessed by pressure and joint manipulation on physical examination. Participants were asked for pain sensations on these manipulations and watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-nontender dichotomy. SJC is the number of swollen joints determined for each participant by examination of 66 joints. Joints were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint.|Baseline, Weeks 12 and 24|All randomized participants who received study drug in Parts A and B and had TJC and SJC evaluated at analysis time points. LOCF was used to impute missing post-baseline values||number of joints||Standard Deviation|Mean
825757|NCT01185353|Secondary|ACR Percent Improvement (ACR-N)|ACR-N is a continuous measure of clinical, laboratory, and functional outcomes in RA that characterizes percentage (%) of improvement in disease activity from baseline based on ACR core set. This index was calculated as minimum of a) % of improvement in TJC, b) % of improvement in SJC, and c) third highest percentage of improvement of remaining 5 ACR core criteria: If ≥3 components of the 5 ACR core criteria were missing, then c) was set to missing; if any of 3 components a), b), or c) were missing, then ACR-N was set to missing. Percentage of improvement was truncated to a range of -100 to 100 to minimize impact of outliers (greater scores indicate greater % improvement) and negative scores indicate a decline. Data presented are model-based Bayesian posterior mean response rates with 95% credible interval.|Baseline through Week 12|All randomized participants who received study drug in Part A. Participants who had missing components of the ACR-N at Week 12 had these components imputed by LOCF.||percentage of improvement||95% Confidence Interval|Number
825758|NCT01185353|Secondary|Percentage of Participants Who Achieved an ACR50 Response Baseline Through Week 12 - Model Based Dose Response|ACR50 Responder Index is a composite of clinical, laboratory, and functional measures in RA. An ACR50 Responder is a participant who had ≥50% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥50% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, HAQ-DI (assessment of participant’s physical function), pain due to RA, and hsCRP. Participants who discontinue before analysis time point are treated as non-responders. Percentage of participants achieving ACR50 response = (number of ACR50 responders) / (number of participants analyzed) * 100. Data presented are model-based Bayesian posterior mean response rates with 95% credible interval.|Baseline through Week 12|All randomized participants who received study drug in Part A. Participants who had missing components of the ACR50 index at analysis time point had these components imputed by LOCF.||percentage of participants||95% Confidence Interval|Number
825759|NCT01185353|Secondary|Percentage of Participants Who Achieved an ACR70 Response Baseline Through Weeks 76 and 128|ACR70 Responder Index is a composite of clinical, laboratory, and functional measures in RA. An ACR70 Responder is a participant who had ≥70% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥70% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, HAQ-DI (assessment of participant’s physical function), pain due to RA, and hsCRP. Participants who discontinue before analysis time points are treated as non-responders. Percentage of participants achieving ACR70 response = (number of ACR70 responders) / (number of participants analyzed) * 100.|Baseline through Weeks 76 and 128|All participants who received study drug in Parts C and D. Participants who had missing components of the ACR70 index at analysis time points had these components imputed by LOCF.||percentage of participants|||Number
825760|NCT01185353|Secondary|Percentage of Participants Who Achieved an ACR70 Responder Index Response Baseline Through Week 24|ACR70 Responder Index is a composite of clinical, laboratory, and functional measures in RA. An ACR70 Responder is a participant who had ≥70% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥70% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, HAQ-DI (assessment of participant’s physical function), pain due to RA, and hsCRP. Participants who discontinue before analysis time points are treated as non-responders. Percentage of participants achieving ACR70 response = (number of ACR70 responders) / (number of participants analyzed) * 100.|Baseline through Weeks 2, 4, 8, 12, 16, 20, 24|All randomized participants who received study drug in Parts A and B. Participants who had missing components of the ACR70 index at analysis time points had these components imputed by LOCF.||percentage of participants|||Number
825761|NCT01185353|Secondary|Percentage of Participants Who Achieved an ACR50 Response Baseline Through Weeks 76 and 128|ACR50 Responder Index is a composite of clinical, laboratory, and functional measures in RA. An ACR50 Responder is a participant who had ≥50% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥50% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, HAQ-DI (assessment of participant’s physical function), pain due to RA, and hsCRP. Participants who discontinue before analysis time points are treated as non-responders. Percentage of participants achieving ACR50 response = (number of ACR50 responders) / (number of participants analyzed) * 100.|Baseline through Weeks 76 and 128|All participants who received study drug in Parts C and D. Participants who had missing components of the ACR50 index at analysis time points had these components imputed by LOCF.||percentage of participants|||Number
825762|NCT01185353|Secondary|Percentage of Participants Who Achieved an ACR 50 Responder Index Response Baseline Through Week 24|ACR50 Responder Index is a composite of clinical, laboratory, and functional measures in RA. An ACR50 Responder is a participant who had ≥50% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥50% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, HAQ-DI (assessment of participant’s physical function), pain due to RA, and hsCRP. Participants who discontinue before analysis time points are treated as non-responders. Percentage of participants achieving ACR50 response = (number of ACR50 responders) / (number of participants analyzed) * 100.|Baseline through Weeks 2, 4, 8, 12, 16, 20, 24|All randomized participants who received study drug in Parts A and B. Participants who had missing components of the ACR50 index at analysis time points had these components imputed by LOCF.||percentage of participants|||Number
825811|NCT01185704|Secondary|Number of Embryos|Embryo is defined as the product of the zygote, two or three days after fertilization of the oocytes.|Day 2-3 post oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])|ITT population included all randomized participants who had received at least 1 dose of the study medication.||embryos||Standard Deviation|Mean
825763|NCT01185353|Secondary|Percentage of Participants Who Achieved an ACR20 Response Baseline Through Weeks 76 and 128|ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in RA. An ACR20 Responder is a participant who had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, HAQ-DI (assessment of participant’s physical function), pain due to RA, and hsCRP. Participants who discontinue before analysis time points are treated as non-responders. Percentage of participants achieving ACR20 response = (number of ACR20 responders) / (number of participants analyzed) * 100.|Baseline through Weeks 76 and 128|All participants who received study drug in Parts C and D. Participants who had missing components of the ACR20 index at analysis time points had these components imputed by LOCF.||percentage of participants|||Number
825764|NCT01185353|Secondary|Percentage of Participants Who Achieved an ACR20 Responder Index Response Baseline Through Week 24|ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in RA. An ACR20 Responder is a participant who had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, HAQ-DI (assessment of participant’s physical function), pain due to RA, and hsCRP. Participants who discontinue before analysis time points are treated as non-responders. Percentage of participants achieving ACR20 response = (number of ACR20 responders) / (number of participants treated) * 100.|Baseline through Weeks 2, 4, 8, 12, 16, 20, 24|All randomized participants who received study drug in Parts A and B. Participants who had missing components of the ACR20 index at analysis time points had these components imputed by LOCF.||percentage of participants|||Number
825765|NCT01185353|Secondary|Percentage of Participants Who Achieved an ACR20 Responder Index Response Baseline Through Week 12 - Model Based Dose Response|ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in RA. An ACR20 Responder is a participant who had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, HAQ-DI (assessment of participant’s physical function), pain due to RA, and hsCRP. Participants who discontinue before analysis time point are treated as non-responders. Percentage of participants achieving ACR20 response = (number of ACR20 responders) / (number of participants analyzed) * 100. Data presented are model-based Bayesian posterior mean response rates with 95% credible interval.|Baseline through Week 12|All randomized participants who received study drug in Part A. Participants who had missing components of the ACR20 index at Week 12 had these components imputed by LOCF.||percentage of participants||95% Confidence Interval|Number
825766|NCT01185353|Primary|Percentage of Participants in the 4 mg and 8 mg Dose Groups Who Achieved an American College of Rheumatology 20 (ACR20) Responder Index Response Baseline Through Week 12|ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR20 Responder is a participant who had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant’s physical function), pain due to RA, and hsCRP. Participants who discontinue before analysis time point are treated as non-responders. Percentage of participants achieving ACR20 response = (number of ACR20 responders) / (number of participants analyzed) * 100.|Baseline through Week 12|All randomized participants who received placebo, 4 mg or 8 mg LY3009104 in Part A. Participants who had missing components of the ACR20 index at Week 12 had these components imputed by last observation carried forward (LOCF).||percentage of participants|||Number
825767|NCT01185509|Secondary|Circulating Tumor Cells (CTCs)|CTCs levels were determined based on established methods.|Assessed when patient comes off-study||09/2017||||
825768|NCT01185509|Secondary|Circulating Tumor Cells (CTCs)|CTCs levels were determined based on established methods.|Assessed at 6 weeks||09/2017||||
825769|NCT01185509|Secondary|Circulating Tumor Cells (CTCs)|CTCs levels were determined based on established methods.|Assessed at baseline||09/2017||||
825770|NCT01185509|Secondary|Progression-Free Survival (PFS)|PFS based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study or death. Per RECIST 1.1 for target lesions: PD is at least a 20% increase in sum LD, taking as reference the smallest sum on study with at least 5 mm absolute increase. For non-target lesions, progression-free means no new lesions or unequivocal progression on existing non-target lesions or not evaluated.|Disease was evaluated radiologically at baseline, on trt every 6 weeks (wks) for the first 18 wks and then every 12 wks and within 2 wks off-study; Median follow-up was 2.7 months.|The analysis dataset is comprised of all treated patients.||months||95% Confidence Interval|Median
825771|NCT01185509|Secondary|Clinical Benefit Rate (CBR)|CBR was defined as achieving complete response (CR), partial response (PR), or stable disease (SD) for 24 weeks or longer based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PD is at least a 20% increase in sum LD of target lesions (smallest sum LD reference), new lesions, and/or unequivocal progression of existing non-target lesions. Stable disease (SD) is defined as any condition not meeting the above criteria. SD needed to be a minimum 24 weeks in duration|Disease was evaluated radiologically at baseline, on trt every 6 weeks (wks) for the first 18 wks and then every 12 wks; Median (range) trt duration was 12 weeks (3-67).|The analysis dataset is comprised of all treated patients.||percentage of patients||95% Confidence Interval|Number
825772|NCT01185509|Primary|Objective Response Rate (ORR)|ORR was defined as the percentage of patients achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.|Disease was evaluated radiologically at baseline, on trt every 6 weeks (wks) for the first 18 wks and then every 12 wks; Median (range) trt duration was 12 weeks (3-67).|The analysis dataset is comprised of all treated patients.||percentage of patients||95% Confidence Interval|Number
825774|NCT01185522|Secondary|Number of Participants for Rheumatoid Arthritis Management With Tocilizumab Treatment up to Month 4|Participants with tocilizumab treatment were managed according to number of tocilizumab treatment received according to Summary of Product Characteristics recommendations, as 8 mg/kg, dose duration of 1-hour, correct infusion progress; and received DMARD, methotrexate, and corticosteroids concomitantly with tocilizumab during Months 1 to 4.|From Baseline (D0) to M 1, M 2, M 3, and M 4|Patient analysis population consisted of all participants included in the study, who respected inclusion criteria, received at least one tocilizumab infusion, had an evaluable FACIT-Fatigue score at inclusion, and at least one evaluable FACIT fatigue score during treatment. n = number of participants available at the particular time point.||Number of Participants|||Number
825775|NCT01185522|Secondary|Correlations Between Fatigue and Other Participant Reported Outcomes at Day 0 and Month 4|Fatigue was assessed by FACIT-Fatigue scale (ranging from 0 [worse score] to 52 [better score]) and VAS fatigue (ranging from 0 [symptom-free and no arthritis symptoms] to 100 [worsening of symptoms and arthritis disease activity]). Other participant reported outcomes (PROs) were VAS for pain and quality of sleep (ranging from 0 [symptom-free and no arthritis symptoms] to 100 [worsening in arthritis disease activity]), SF36 vitality score (ranging from 0 [worst] to 100 [best]) and HAD score (calculated using the 14 items and each item was scored 0, 1, 2 or 3 where a score of 3 corresponds to the most anxious/depressed. 7-item depression and 7-item anxiety subscales were summed; each resulting in a total score of 0-21). Correlation between fatigue as assessed by FACIT-Fatigue score or VAS fatigue was evaluated for all participants using a linear regression and were reported for D0 and M4.|Day 0 and Month 4|Patient analysis population consisted of all participants included in the study, who respected inclusion criteria, received at least one tocilizumab infusion, had an evaluable FACIT-Fatigue score at inclusion, and at least one evaluable FACIT fatigue score during treatment. n = number of participants available at the particular time point.||Coefficient of correlation|||Number
825776|NCT01185522|Secondary|Percentage of Participants With FACIT-Fatigue Score, SF36 Vitality Score, and VAS Fatigue at Day 0 and Month 4|FACIT-Fatigue score (ranging from 0 [worse score] to 52 [better score]), VAS (ranging from 0 [symptom-free and no arthritis symptoms] to 100 [worsening in arthritis disease activity]) and SF36 vitality score (ranging from 0 [worst] to 100 [best]) were calculated at Baseline and Month 4.|Baseline (D0) and Month 4|Patient analysis population consisted of all participants included in the study, who respected inclusion criteria, received at least one tocilizumab infusion, had an evaluable FACIT-Fatigue score at inclusion, and at least one evaluable FACIT fatigue score during treatment. n = number of participants available at the particular time point.||Percentage of participants|||Number
825777|NCT01185522|Secondary|Number of Participants Achieving PASS Score at Baseline (Day 0) and Month 4|A PASS score at Day 0 and Month 4 calculated on participants with acceptable symptom state. PASS is defined as the highest level of symptom beyond which participants consider themselves well. PASS is a 1-question assessment of how rheumatoid arthritis has affected participant in last 48 hours.|Baseline (D0) and Month 4|Patient analysis population consisted of all participants included in the study, who respected inclusion criteria, received at least one tocilizumab infusion, had an evaluable FACIT-Fatigue score at inclusion, and at least one evaluable FACIT fatigue score during treatment. n = number of participants available at the particular time point.||Number of participants|||Number
825778|NCT01185522|Secondary|Relative Median Change From Baseline in C - Reacting Protein at Month 1, Month 2, Month 3, and Month 4|The correlation between fatigue and CRP value was evaluated for all participants at each evaluation time (on raw data at inclusion; on relative changes at M1 to M4) using a linear regression. CRP values were described as continuous variables for all participants at each evaluation time (Baseline to M4).|From Baseline (D0) to M 1, M 2, M 3, and M 4|Patient analysis population was considered. Participants with Changes in CRP level up to Month 4 were analyzed for this outcome measure. n = number of participants available at specified time points.||Percent change||Full Range|Median
825779|NCT01185522|Secondary|Relative Median Change From Baseline in ESR to Month 1, Month 2, Month 3, and Month 4|The correlation between fatigue and ESR value was evaluated for all participants at each evaluation time (on raw data at inclusion; on relative changes at M1 to M4) using a linear regression. ESR values were described as continuous variables for all participants at each evaluation time (Baseline to M4).|From Baseline (D0) to M 1, M 2, M 3, and M 4|Patient analysis population was considered. Participants with Changes in ESR values up to Month 4 were analyzed for this outcome measure. n = number of participants available at specified time points.||Percent change||Full Range|Median
825780|NCT01185522|Secondary|Relative Median Change From Baseline in Disease Activity (Tender Joint Count and Swollen Joint Count) to Month 1, Month 2, Month 3, and Month 4|"Relative change (RC) from Baseline (BL) in disease activity included TJC and SJC was evaluated as continuous variables for all participants at each evaluation time points.
For tender joint count, a total of 68 joints were assessed. The presence of a tender joint was scored as 1 and absence as 0. Total score is calculated by adding the scores, which is ranging from 0 (best possible score or no tender joint) to 68 (worse possible score or all tender joints). Lower scores indicate no tender joint and higher scores indicate worsening tender joints. For swollen joint count, a total of 66 joints were assessed. The presence of a tender joint was scored as 1 and absence as 0. Total score is calculated by adding the scores, which is ranging from 0 (best possible score or no swollen joint) to 66 (worse possible score or all swollen joints). Lower scores indicate no swollen joint and higher scores indicate worsening swollen joints."|From Baseline (D0) to M 1, M 2, M 3, and M 4|Patient analysis population was considered. Participants with changes in TJC and SJC up to Month 4 were analyzed for this outcome measure. n = number of participants available for particular parameters at specified time points.||Percent change||Full Range|Median
825781|NCT01185522|Secondary|Relative Median Change From Baseline in DAS 28 and VAS Patient’s Global Assessment to Month 1, Month 2, Month 3, and Month 4|Relative change from Baseline (BL) in DAS 28 was evaluated for all participants at each evaluation time (on raw data at inclusion; at Month 1, Month 2, Month 3, and Month 4 using a linear regression. DAS-28 and VAS patient’s global assessment (PGA) were described as continuous variables for all participants at each evaluation time points (Baseline to M4). DAS 28 ranging from 0 (no disease activity) to 10 (worsening in disease activity) and VAS PGA ranging from 0 (symptom-free and no arthritis symptoms) to 100 (worsening of symptoms and arthritis disease activity),|From Baseline (D0) to M 1, M 2, M 3, and M 4|Patient analysis population was considered. Participants with changes in DAS 28 up to Month 4 were analyzed for this outcome measure. n = number of participants available for particular parameters at specified time points.||Percent change||Full Range|Median
825782|NCT01185522|Secondary|Median Time to Onset of an Improvement of the FACIT-Fatigue Score|The time of onset of a clinically significant improvement of fatigue was defined as the time between the date of the first tocilizumab infusion and the date of the first increase of at least 4 points of the FACIT-Fatigue score (date of questionnaire completion) during 4 months of tocilizumab treatment. FACIT-Fatigue score assesses self-reported fatigue and its impact upon daily activities and function. It is calculated with 13-item questionnaire on 5-point scale, 0 (not at all) to 4 (very much). The larger the participant’s response to the questions (exception of 2 negatively stated), the greater the participants fatigue. For all questions (except for 2 negatively stated), the code is reversed and a new score is calculated as 4 minus the participant’s response. The sum of all responses results a total possible score of 0 (worse score) to 52 (better score).|Up to Month 4|Patient analysis population was considered. Participants with increase of at least 4 points of the FACIT-Fatigue score were analyzed for this outcome measure.||Months||95% Confidence Interval|Median
825783|NCT01185522|Secondary|Correlation Between Relative Changes From Baseline of FACIT-Fatigue Score and VAS Fatigue to 4 Months of Tocilizumab Treatment|Correlation between FACIT-Fatigue score and VAS fatigue was evaluated for all participants at inclusion and after 4 months of tocilizumab treatment (relative change from baseline) using a linear regression. FACIT-Fatigue score assesses self-reported fatigue and its impact upon daily activities and function. It is calculated with 13-item questionnaire on 5-point scale, 0 (not at all) to 4 (very much). The larger the participant’s response to the questions (exception of 2 negatively stated), the greater the participants fatigue. For all questions (except for 2 negatively stated), the code is reversed and a new score is calculated as 4 minus the participant’s response. The sum of all responses results a total possible score of 0 (worse score) to 52 (better score). VAS fatigue score ranging from 0 (symptom-free and no arthritis symptoms) to 100 (worsening in symptoms and arthritis disease activity)|From Baseline (D0) to Month (M) 4|Patient analysis population was considered. Participants with Changes in FACIT-Fatigue Score and VAS Fatigue at Month 4 were analyzed for this outcome measure.||Correlation Coefficient|||Number
825784|NCT01185522|Primary|Mean Clinically Significant Improvement in Tender Joints and Swollen Joints as Predictive Factors After 4 Months of Tocilizumab Treatment|"Predictive factors were characteristics of participants that indicated greater or lesser likelihood of responding to a specific treatment regimen.
For tender joint count (TJC), a total of 68 joints were assessed. The presence of a tender joint was scored as 1 and absence as 0. Total score is calculated by adding the scores, which is ranging from 0 (best possible score or no tender joint) to 68 (worse possible score or all tender joints). Lower scores indicate no tender joint and higher scores indicate worsening tender joints.
For swollen joint count (SJC), a total of 66 joints were assessed. The presence of a tender joint was scored as 1 and absence as 0. Total score is calculated by adding the scores, which is ranging from 0 (best possible score or no swollen joint) to 66 (worse possible score or all swollen joints). Lower scores indicate no swollen joint and higher scores indicate worsening swollen joints."|At Month 4|Patient analysis population was considered. Participants who completed a FACIT-Fatigue score at Month 4 and had clinically significant improvement in fatigue with respect to predictive factors were analyzed for this outcome measure.||Number of joints||Standard Deviation|Mean
825785|NCT01185522|Primary|Median Clinically Significant Improvement in C-Reactive Protein as a Predictive Factors After 4 Months of Tocilizumab Treatment|Predictive factors were characteristics of participants that indicated greater or lesser likelihood of responding to a specific treatment regimen. C-reactive protein (CRP) is one of the biomarkers for the diagnosis and assessment of disease activity in RA.|At Month 4|Patient analysis population was considered. Participants who completed a FACIT-Fatigue score at Month 4 and had clinically significant improvement in fatigue with respect to predictive factors were analyzed for this outcome measure.||milligram per liter||Inter-Quartile Range|Median
825786|NCT01185522|Primary|Number of Participants With Clinically Significant Improvement in Fatigue at Month 4 With Respect to Predictive Factors|Predictive factors of fatigue were taken into account included gender, age, time since initial diagnosis, Erosive RA, disease activity score (DAS, ranging from 0 [no disease activity] to 10 [worsening in disease activity]), erythrocyte sedimentation rate (ESR), anemia, treatment with corticosteroids, doses of corticosteroids, health assessment questionnaire (HAQ, ranging from 0 [without any difficulty] to 60 [worsening or unable to do physical activities]), FACIT-Fatigue score (ranging from 0 [worse score] to 52 [better score]), visual analogue score (VAS) for fatigue, pain, quality of sleep, and global assessment (ranging from 0 [symptom-free and no arthritis symptoms] to 100 [worsening of symptoms and arthritis disease activity]), Short Form 36 (SF36) vitality score (ranging from 0 [worst] to 100 [best]), Hospital Anxiety and Depression Scale (HADS; represented as score </= 7 [no case], 7 to 10 [doubtful case], and > 10 [certain case of HAD]).|At Month 4|Patient analysis population was considered. Participants whom baseline characteristics were available at inclusion and who completed a FACIT-Fatigue score at Month 4 and had clinically significant improvement in fatigue with respect to predictive factors were analyzed for this outcome measure.||Number of participants|||Number
825787|NCT01185522|Secondary|Baseline Disease Characteristic: Mean FACIT-Fatigue Score and VAS Fatigue Score|FACIT-fatigue score and VAS fatigue score were fatigue assessment parameters. FACIT-Fatigue score assesses self-reported fatigue and its impact upon daily activities and function. It is calculated with 13-item questionnaire on 5-point scale, 0 (not at all) to 4 (very much). The larger the participant’s response to the questions (exception of 2 negatively stated), the greater the participants fatigue. For all questions (except for 2 negatively stated), the code is reversed and a new score is calculated as 4 minus the participant’s response. The sum of all responses results a total possible score of 0 (worse score) to 52 (better score). VAS fatigue score ranges from 0 (symptom-free and no arthritis symptoms) to 100 (worsening in symptoms and arthritis disease activity). Clinically relevant improvement is defined as >/= 4-point change from Baseline.|Baseline (D0)|Patient analysis population consisted of all participants included in the study, who respected inclusion criteria, received at least one tocilizumab infusion, had an evaluable FACIT-Fatigue score at inclusion, and at least one evaluable FACIT fatigue score during treatment. n = number of participants available for particular time fatigue scores.||Scores on a scale||Standard Deviation|Mean
825911|NCT01194479|Primary|Epinephrine (pg/mL)|Epinephrine levels will be measured throughout the study to assess whether there are changes during hypoglycemia with inhaled formoterol. These levels will be checked every 20 minutes during the 120 minute study session. Results are presented at the Basal, Euglycemia (30 minutes) and Hypoglycemia (105-120 minutes) stages|up to 120 minutes|Results are pooled at the arm level and split by placebo and control regardless of randomization order.||pg/mL||Standard Error|Mean
825788|NCT01185522|Secondary|Baseline Disease Characteristic: Number of Participants With High Erythrocyte Sedimentation Rate, CRP Level, Anemia, and Unacceptable Patient Acceptable Symptom State Fatigue|High Erythrocyte Sedimentation Rate (ESR) was defined as (1) for participants aged up to 50 years: > 15 mm/h for men and > 20 mm/h for women, and (2) for participants aged over 50 years: > 20 mm/h for men and > 25 mm/h for women. Anemia was defined as plasma hemoglobin level <12 gram per deciliter (g/dL) for women and <13 g/dL for men. The CRP test is evaluated for an acute phase reactant of inflammation. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Patient-Acceptable Symptom State (PASS) that is defined as the highest level of symptom beyond which participants consider themselves well. PASS is a 1-question assessment of how rheumatoid arthritis has affected participant in last 48 hours.|Baseline (D0)|Patient analysis population consisted of all participants included in the study, who respected inclusion criteria, received at least one tocilizumab infusion, had an evaluable FACIT-Fatigue score at inclusion, and at least one evaluable FACIT fatigue score during treatment. n = number of participants available for particular parameters.||Number of participants|||Number
825789|NCT01185522|Secondary|Baseline Disease Characteristic: DAS28, Patient’s Global Assessment, VAS Pain and HAQ Score as Rheumatoid Arthritis Assessment Parameters|DAS28 is a combined index for measuring disease activity in RA. The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/h), and patient's global assessment of disease activity (measured on a 100-mm visual analog scale, where 0 is no disease activity and 100 is maximum disease activity). The DAS28 scale ranges from 0 to 10, where higher scores indicate worsening disease activity. VAS pain score calculated as 0 to 10 cm; where 0 = no pain, and 10 = worst possible pain. HAQ indicates how the disease affected participant’s activities of daily life. It consisted of 20 questions in 8 domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities) rated on a 4-point scale, 0=without any difficulty to 3=unable to do. Sum of scores was divided by number of domains with a score for a total possible score of 0 (best/no difficulties to perform activities) to 3 (worst/ unable to perform activities at all).|Baseline (D0)|Patient analysis population consisted of all participants included in the study, who respected inclusion criteria, received at least one tocilizumab infusion, had an evaluable FACIT-Fatigue score at inclusion, and at least one evaluable FACIT fatigue score during treatment. n = number of participants available for particular parameters.||Scores on a scale||Standard Deviation|Mean
825790|NCT01185522|Secondary|Baseline Disease Characteristics: Tender Joint Count and Swollen Joint Count|"For tender joint count, a total of 68 joints were assessed. The presence of a tender joint was scored as 1 and absence as 0. Total score is calculated by adding the scores, which is ranging from 0 (best possible score or no tender joint) to 68 (worse possible score or all tender joints). Lower scores indicate no tender joint and higher scores indicate worsening tender joints.
For swollen joint count, a total of 66 joints were assessed. The presence of a tender joint was scored as 1 and absence as 0. Total score is calculated by adding the scores, which is ranging from 0 (best possible score or no swollen joint) to 66 (worse possible score or all swollen joints). Lower scores indicate no swollen joint and higher scores indicate worsening swollen joints. Tender joint count and swollen joint count were assessed at baseline and were used as baseline disease characteristics for assessment of rheumatoid arthritis."|Baseline (D0)|Patient analysis population was considered. n = number of participants available for particular parameters.||Number of joints||Standard Deviation|Mean
825791|NCT01185522|Secondary|Baseline Disease Characteristics: Number of Participants With Positive Rheumatoid Factor and/or Anti-cyclic Citrullinated Protein Antibodies|Blood was collected for Rheumatoid Factor (RF) at Baseline and was analyzed. RF level was reported in international units/milliliter (IU/mL). All participants were assessed for anti-cyclic citrullinated protein (anti-CCP) antibodies at baseline. Number of participants with a positive RF and/or anti-CCP antibodies were reported as baseline disease characteristics.|Baseline (D0)|Patient analysis population was considered. Participants with positive RF and/or anti-CCP antibodies at baseline were analyzed for this outcome measure.||Number of Participants|||Number
825792|NCT01185522|Secondary|Baseline Disease Characteristics: Mean Disease Duration|Mean disease (rheumatoid arthritis) duration at inclusion was recorded for all participants as baseline disease characteristics.|Baseline (Day [D] 0)|Patient analysis population was considered. Participants for whom data of disease duration was available at baseline were analyzed for this outcome measure.||years||Standard Deviation|Mean
825793|NCT01185522|Primary|Percentage of Participants With a Clinically Significant Improvement in Fatigue After 4 Months of Tocilizumab Treatment|"Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score assesses self-reported fatigue and its impact upon daily activities and function. It is calculated with 13-item questionnaire on 5-point scale: 0 (not at all) to 4 (very much). The larger the participant’s response to the questions (exception of 2 negatively stated), the greater the participants fatigue. For all questions (except for 2 negatively stated), the code is reversed and a new score is calculated as 4 minus the participant’s response. The sum of all responses resulted a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the participant’s health status. Clinically relevant improvement is defined as a >= 4-point change from Baseline.
This was performed using the last observation carried forward (LOCF) method and for participants who completed a FACIT-Fatigue score at Month 4 (completers)."|At Month 4|Patient analysis population consisted of all participants included in the study, who respected inclusion criteria, received at least one tocilizumab infusion, had an evaluable FACIT-Fatigue score at inclusion, and at least one evaluable FACIT fatigue score during treatment.||Percentage of participants||95% Confidence Interval|Number
825794|NCT01185561|Secondary|State–Trait Anger Expression Inventory (STAXI) Anger Expression Sub-test Score|Scores on the The State–Trait Anger Expression Inventory (STAXI) Anger Expression Sub-test will be compared between those assigned to intervention versus those assigned to usual medical care six months after randomization. The STAXI anger expression subtest is a 24-item scale measuring how anger is generally being experienced and expressed. Scores may range from 0 to 72 with higher scores indicating greater anger.|6 Months|This analysis is restricted to participants who completed the final study visit six months after randomization.||units on a scale||Standard Deviation|Mean
825912|NCT01194479|Secondary|Blood Glucose Levels (Average)|Blood glucose levels will be checked every 5 minutes during the 120 minute study session in order to maintain blood glucose levels in the normal and hypoglycemic range. Presented is the average of the collected values.|Up to 120 minutes|Subjects are pooled across randomized conditions in their respective study arms and reported overall.||mg/dL||Standard Deviation|Mean
825796|NCT01185561|Secondary|State–Trait Anxiety Inventory (STAI Form Y-1) State Anxiety Sub-test Score|Scores on the The State–Trait Anxiety Inventory (STAI Form Y-1) State Anxiety Sub-test are compared between those assigned to intervention versus those assigned to usual medical care six months after randomization. The STAI state anxiety subtest is a 20-item scale measuring state anxiety. Scores may range from 20 to 80 with higher scores indicating greater state anxiety.|6 Months|This analysis is restricted to participants who completed the final study visit six months after randomization.||units on a scale||Standard Deviation|Mean
825797|NCT01185561|Primary|Center for Epidemiologic Studies Depression (CES-D) Score|The CES-D score was compared between those assigned to intervention versus those assigned to usual medical care six months after randomization. The CES-D is a self-report questionnaire assessing frequency and severity of depression symptoms. Scores may range from 0 to 60, where higher scores indicate worse mood.|6 Months|This analysis is restricted to participants who completed the final study visit six months after randomization.||units on a scale||Standard Deviation|Mean
825798|NCT01185600|Secondary|Each Participant's Number of Non-serious Adverse Events|All clinical non-serious adverse events reported in the clinical chart were recorded in the study's data files. This type of events, defined as Non-Serious Adverse Events or just Adverse Events (AEs) were categorized into 5 groups: (1) Cardiovascular / respiratory; (2) renal; (3) neurologic (CNS); (4) infections; and (5) other. For each participant, the outcome measure was defined as the number of AE's he or she experienced during his/her hospital stay.|Within 30 days after CABG surgery|||Adverse events||Standard Deviation|Mean
825799|NCT01185600|Primary|Difference in Levels of Circulating CD235a+ Red Cell Microparticles 1 Hour Post-surgery|Difference in levels of circulating CD235a+ red cell microparticles between at 1 hour post-surgery and at pre-surgery, i.e. levels at 1 hour post-surgery - level at pre-surgery|Interval between pre-surgery and 1 hour post-surgery|||counts / uL||Standard Deviation|Mean
825800|NCT01185600|Primary|Difference in Levels of Circulating CD62E+ Endothelial Microparticles 1 Hour Post-surgery|Difference in levels of circulating CD62E+ endothelial microparticles between 1 hour post-surgery and at pre-surgery, i.e. level at 1 hour post-surgery - level at pre-surgery|Interval between pre-surgery and 1 hour post-surgery|"There were 2 participants' blood samples were not performed due to clotting or missing samples in the Group of Transfusion with unwashed RBC. Therefore, the total number is 57 instead of 59 in that group."||counts / uL||Standard Deviation|Mean
825801|NCT01185600|Primary|Difference in Levels of Circulating Annexin V+ Microparticles 1 Hour Post- Surgery|Difference in levels of circulating Annexin V+ microparticles between at pre-surgery and 1 hour post-surgery, i.e. level of Annexin V+ microparticles at 1 hour post-surgery - level of Annexin V+ microparticles at pre-surgery|Interval between pre-surgery and 1 hour post-surgery|"There were 2 participants' blood samples were not performed due to clotting or missing samples in the Group of Transfusion with unwashed RBC. Therefore, the total number is 57 instead of 59 in that group."||counts / uL||Standard Deviation|Mean
825802|NCT01185600|Primary|Difference in Levels of Circulating CD41+ Platelet-derived Microparticles 1 Hour Post-surgery|Difference in levels of circulating CD41+ platelet microparticles between at pre-surgery and at 1hour post-surgery, i.e. level at 1hour post-surgery - level at pre-surgery|interval between presurgery and 1 hour post-surgery|"There were 2 participants' blood samples were not performed due to clotting or missing samples in the Group of Transfusion with unwashed RBC. Therefore, the total number is 57 instead of 59 in that group."||counts / uL||Standard Deviation|Mean
825803|NCT01185600|Primary|Occurrence of at Least One Serious Adverse Event (SAE)|Comparison of the two groups with respect to occurrence or not of at least one SAE including sepsis, respiratory failure, multi-organ failure, anaphylactic shock, transfusion-related acute lung injury, MI, stroke, cardiac arrest.|within 30 days after CABG surgery|||participants|||Number
825804|NCT01185600|Primary|One-year Mortality|Number participants who expired within one year after CABG surgery|Within one year after CABG surgery|During the 12 months after hospital discharge, one participant in the group of transfusion with washed RBC and 3 participants in the group of transfusion with unwashed RBC were lost to follow up.||participants|||Number
825805|NCT01185600|Primary|In Hospital Mortality|The number of participants who expired during hospital stay after CABG surgery|Within 30 days after CABG surgery|||participants|||Number
825806|NCT01185704|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered. A Serious Adverse Event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. To avoid the participant/event combination double-count AEs and SAEs are reported separately.|Day 1 up to end of study (15 days post last administration of study drug)|||participants|||Number
825807|NCT01185704|Secondary|Percentage of Participants With Clinical Pregnancy|Clinical pregnancy was defined as pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It excludes ectopic pregnancy.|10 weeks post r-hCG day (end of stimulation cycle [approximately 15 days])|ITT population included all randomized participants who had received at least 1 dose of the study medication.||percentage of participants|||Number
825808|NCT01185704|Secondary|Implantation Rate|Implantation rate per reporting group was measured as the number of gestational sacs observed, divided by the number of embryos transferred multiplied by 100.|5 weeks post oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])|ITT population included all randomized participants who had received at least 1 dose of the study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||percent sacs per embryo|||Number
825809|NCT01185704|Secondary|Number of Transferred Embryos|Embryo transfer is the procedure in which one or more embryos are placed in the uterus.|Day 2-3 post Oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])|ITT population included all randomized participants who had received at least 1 dose of the study medication.||transferred embryos||Standard Deviation|Mean
826255|NCT01188811|Primary|Brain Atrophy by MRI||% change brain volume from baseline to year 2|22 subjects in the lipoic acid group and 24 in the placebo group completed the MRI outcome. Two outliers in the lipoic acid group were not included in analysis.||whole brain percent volume change||Standard Deviation|Mean
825812|NCT01185704|Secondary|Percentage of Fertilized Oocytes Retrieved|Oocytes were fertilized using Intra-cytoplasmic Sperm Injection (ICSI) technique which is an IVF procedure in which a single sperm is injected directly into an egg under a microscope.|Oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])|ITT population included all randomized participants who had received at least 1 dose of the study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||percent fertilized oocytes||Standard Deviation|Mean
825813|NCT01185704|Secondary|Total Dose of Recombinant Human Follicle Stimulating Hormone (r-hFSH)||Day 1 up to r-hCG day (end of stimulation cycle [approximately 15 days])|ITT population included all randomized participants who had received at least 1 dose of the study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||international unit (IU)||Standard Deviation|Mean
825814|NCT01185704|Secondary|Number and Quality of Oocytes Retrieved|Oocyte retrieval is a technique used in in-vitro fertilization (IVF) in order to remove oocytes from the ovary of the female participant, enabling fertilization outside the body. Oocytes were classified into 4 different categories based on their quality: mature, fractured, immature and inseminated oocytes.|Oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])|ITT population included all randomized participants who had received at least 1 dose of the study medication.||oocytes||Standard Deviation|Mean
825815|NCT01185704|Secondary|Number of Follicles Greater Than or Equal (>=) to 17 mm (For Day 1 Protocol) or 19 mm (For Day 7 Protocol) on r-hCG Day||r-hCG day (end of stimulation cycle [approximately 15 days])|ITT population included all randomized participants who had received at least 1 dose of the study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||follicles||Standard Deviation|Mean
825816|NCT01185704|Secondary|Anti Mullerian Hormone (AMH) Levels||Day 0|ITT population included all randomized participants who had received at least 1 dose of the study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
825817|NCT01185704|Secondary|Serum Progesterone (P4) Levels||Day 1|ITT population included all randomized participants who had received at least 1 dose of the study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||nanomolar/liter (nmol/L)||Standard Deviation|Mean
825818|NCT01185704|Secondary|Serum Estradiol (E2) Levels||Day 1|ITT population included all randomized participants who had received at least 1 dose of the study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||pg/mL||Standard Deviation|Mean
825819|NCT01185704|Secondary|Serum Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Levels||Day 1|"ITT population included all randomized participants who had received at least 1 dose of the study medication. N (number of participants analyzed) signifies those participants who were evaluable for this measure. Here n signifies those participants who were evaluated for specified category."||International unit/liter (IU/L)||Standard Deviation|Mean
825820|NCT01185704|Primary|Estradiol (E2) Levels on r-hCG Day||r-hCG day (end of stimulation cycle [approximately 15 days])|"Intent to treat (ITT) population included all randomized participants who had received at least 1 dose of the study medication. N (number of participants analyzed) signifies those participants who were evaluable for this measure."||picogram/milliliter (pg/mL)||Standard Deviation|Mean
825821|NCT01185782|Secondary|Number of Participants With OHSS|OHSS is a syndrome which can manifest with enlarged ovaries, advanced ascites with increased vascular permeability, pleural fluid accumulation, hemoconcentration, and increased blood clotting.|Start of treatment period to post-treatment assessment period (Day 35-42)|Safety population included all participants who received at least 1 dose of IMP. This was actually identical to the FAS population.||participants|||Number
825822|NCT01185782|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and AEs Leading to Study Drug Discontinuation|AEs: Any untoward medical occurrence in the form of signs, clinically significant abnormalities in laboratory findings, diseases, symptoms, or worsening of complications. TEAEs: AEs that occur during treatment with the IMP. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition. Participants who discontinued from the study due to AE were also recorded.|Pretrial observation period to post-treatment assessment period (Days 35-42)|Safety population included all participants who received at least 1 dose of IMP. This was actually identical to the FAS population.||participants|||Number
825823|NCT01185782|Secondary|Ovulation Rate, Where Ovulation is Defined as a Serum P4 Level Greater Than or Equal to 10 ng/mL or Clinical Pregnancy|For this secondary endpoint, participants were considered to have ovulated if serum P4 level was more than or equal to 10 ng/mL on Day 6±1 or 9±1 during the post-treatment assessment period, or if the participant became clinically pregnant.|On Day 6±1 or 9±1 during post-treatment assessment period|FAS included all participants who received at least 1 dose of IMP and had no major violation of GCP such as non-compliance with the agreement, serious protocol violations, etc.||percent ovulation|||Number
825824|NCT01185782|Secondary|Clinical Pregnancy Rate|Clinical pregnancy was defined as existence of at least one ultrasonography confirmed gestational sac in the uterus, with or without heartbeat.|Day 35-42 of post-treatment assessment period|FAS included all participants who received at least 1 dose of IMP and had no major violation of GCP such as non-compliance with the agreement, serious protocol violations, etc.||percent clinical pregnancy|||Number
825825|NCT01185782|Secondary|Biochemical Pregnancy Rate|Biochemical pregnancy was defined as a positive pregnancy test (urinary beta-hCG test) on Day 28-31 of the post-treatment assessment period|Day 28-31 of post-treatment assessment period|FAS included all participants who received at least 1 dose of IMP and had no major violation of GCP such as non-compliance with the agreement, serious protocol violations, etc.||percent biochemical pregnancy|||Number
825826|NCT01185782|Secondary|Single Follicle Maturation Rate|Single follicle maturation was defined as the presence of the dominant follicle with a mean diameter of 18 mm or greater without concurrent presence of other follicles of 14 mm or larger in diameter.|Start of treatment period until Day 1 of post-treatment assessment period|FAS included all participants who received at least 1 dose of IMP and had no major violation of GCP such as non-compliance with the agreement, serious protocol violations, etc.||percent single follicle maturation|||Number
825827|NCT01185782|Secondary|Human Chorionic Gonadotropin (hCG) Cancellation Rate|hCG cancellation criterion was defined as the presence of 4 or more ovarian follicles with a mean diameter greater than or equal to 16 mm. If the hCG cancellation criterion was met, the administration of hCG was withheld. Otherwise, a single intramuscular dose of hCG 5000 IU (Japanese Pharmacopoeia- JP) was administered within 24 hours of the last ultrasound examination.|Day 1 of post-treatment assessment period|FAS included all participants who received at least 1 dose of IMP and had no major violation of GCP such as non-compliance with the agreement, serious protocol violations, etc.||percent hCG cancellation|||Number
825828|NCT01185782|Secondary|Total Dose of the Investigational Medicinal Product (IMP) Administered to Participants With Dominant Follicle Achieving 18 mm in Mean Diameter|Total dose of IMP administered was defined as the cumulative dose administered from the start of treatment with IMP until the mean diameter of the dominant follicle reached 18 mm.|Start of treatment period until Day 1 of post-treatment assessment period|FAS included all participants who received at least 1 dose of IMP and had no major violation of GCP such as non-compliance with the agreement, serious protocol violations, etc. Only participants in whom the dominant follicle reached 18 mm in mean diameter were considered for the analysis of this parameter.||IU||Standard Deviation|Mean
825829|NCT01185782|Secondary|Time for Dominant Follicle to Achieve 18 mm in Mean Diameter|Dosing time length was calculated as number of days from the first administration of the IMP until the mean diameter of the dominant follicle was confirmed to have reached 18 mm.|Start of treatment period until Day 1 of post-treatment assessment period|FAS included all participants who received at least 1 dose of IMP and had no major violation of GCP such as non-compliance with the agreement, serious protocol violations, etc. Only participants in whom the dominant follicle reached 18 mm in mean diameter were considered for the analysis.||days||Standard Deviation|Mean
825830|NCT01185782|Secondary|Number of Participants With the Dominant Follicle Achieving 18 mm in Mean Diameter||Start of treatment period until Day 1 of post-treatment assessment period|FAS included all participants who received at least 1 dose of IMP and had no major violation of GCP such as non-compliance with the agreement, serious protocol violations, etc.||participants|||Number
825831|NCT01185782|Primary|Percentage of Participants With Ovulation|Participants were considered to have ovulated if serum progesterone (P4) level was greater than or equal to 5 nanogram (ng)/mL on Day 6±1 or 9±1 during the post-treatment assessment period, or if the participant became clinically pregnant.|On Day 6±1 or 9±1 days during post-treatment assessment period (Day 35-42 of post-treatment period for clinical pregnancy)]|Full analysis set (FAS) included all participants who received at least 1 dose of IMP and had no major violation of Good Clinical Practice (GCP) such as non-compliance with the agreement, serious protocol violations, etc.||percentage of participants|||Number
825832|NCT01192776|Other Pre-specified|Severe Neonatal Brain Abnormalities|"The data for this analysis have not yet been collected.
MRIs taken between 7-14 days will be examined."|7-14 days of life||07/2020||||
825833|NCT01192776|Secondary|Multiorgan Dysfunction|The data needed for this analysis are not collected directly, and needs to be coded based on the available information. This is a complex undertaking and will take additional time to create. Once created, we will promptly report the results and anticipate reporting by March 2018.|Until death, discharge, or transfer||03/2018||||
825834|NCT01192776|Secondary|Multiple Disabilities|Multiple disabilities is defined as two or more of the following 5 components: disabling CP, GMFCS level 3-5, Bayley cognitive score < 70, blindness, or deafness.|Follow up at 18-22 months corrected age|Infants who survived and were followed at 18-22 months||Participants|||Count of Participants
825835|NCT01192776|Secondary|Hearing Impairment|Hearing impairment is defined as hearing impairment despite amplification|Follow up at 18-22 months corrected age|Infants who survived and were followed at 18-22 months||Participants|||Count of Participants
825836|NCT01192776|Secondary|Visual Impairment|Visual impairment is defined as bilateral blindness with some/no useful vision|Follow up at 18-22 months corrected age|Infants who survived and were followed at 18-22 months||Participants|||Count of Participants
825837|NCT01192776|Secondary|Level of Disability Among Survivors, by Level of HIE|Among survivors, number of normal infants and infants with mild, moderate and severe disability Severe disability was defined by any of the following: a Bayley III cognitive score <70, a GMFCS level of 3-5, blindness or profound hearing loss (inability to understand commands despite amplification). Moderate disability was defined as a Bayley cognitive score of 70-84 and either a GMFCS level of 2, seizure disorder, or a hearing deficit requiring amplification to understand commands. Mild impairment was defined by a cognitive score 70-84, or a cognitive score ≥ 85 and any of the following: presence of a GMFCS level 1 or 2, seizure disorder or hearing loss not requiring amplification. Normal was defined by a cognitive score ≥ 85 in the absence of any neurosensory deficits or seizures after NICU discharge.|Follow up at 18-22 months corrected age|Includes all infants followed at 18-22 months, except for 6 infants who could not be distinguished between normal and mild. Does not include 17 infants lost to follow up or 56 deaths.||Participants|||Count of Participants
825838|NCT01192776|Secondary|Cerebral Palsy||Follow up at 18-22 months corrected age|Infants who survived and were followed at 18-22 months||Participants|||Count of Participants
825839|NCT01192776|Secondary|Bayley Cognitive Score|Bayley Scale of Infant Development Composite Cognitive Score. The total composite score is reported, ranging from the lowest score of 55 to the highest score of 145. Lower values specify worse outcome.|Follow up at 18-22 months corrected age|Infants who survived and were followed at 18-22 months||scores on a scale||Inter-Quartile Range|Median
825840|NCT01192776|Secondary|Clinical Neonatal Seizures|Documented seizures during hospital course|Through death, discharge, or transfer|||Participants|||Count of Participants
825841|NCT01192776|Secondary|Withdrawal of Care|Number of infants for whom aggressive care is withdrawn|Birth through hospital discharge, average 22 days.|||Participants|||Count of Participants
825852|NCT01193049|Secondary|Geometric Mean Fold Change From Baseline in RNA Expression for Genes Encoding IL-5 and IL-13 From Sputum at 7 Hours Post-allergen Challenge|Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, SP were collected, then the RNA expression profiles of IL-5 and IL-13 genes were determined from SP collected after 7 hours and previously at baseline, to derive the FC from BL for each participant. The GM was determined by averaging FC from BL for all analyzed participants.|Baseline and 7 hours post-allergen challenge|All randomized participants||Fold Change||90% Confidence Interval|Geometric Mean
825842|NCT01192776|Secondary|Level of Disability Among Survivors|"Among survivors number of normal infants and infants with mild, moderate, and severe disability
Severe disability was defined by any of the following: a Bayley III cognitive score <70, a GMFCS level of 3-5, blindness or profound hearing loss (inability to understand commands despite amplification). Moderate disability was defined as a Bayley cognitive score of 70-84 and either a GMFCS level of 2, seizure disorder, or a hearing deficit requiring amplification to understand commands. Mild impairment was defined by a cognitive score 70-84, or a cognitive score ≥ 85 and any of the following: presence of a GMFCS level 1 or 2, seizure disorder or hearing loss not requiring amplification. Normal was defined by a cognitive score ≥ 85 in the absence of any neurosensory deficits or seizures after NICU discharge."|Follow up at 18-22 months corrected age|Includes all infants followed at 18-22 months except for 6 infants who could not be distinguished between normal and mild. Does not include 17 infants lost to follow up or 56 deaths||Participants|||Count of Participants
825843|NCT01192776|Secondary|Death|Death includes any mortality prior to follow up at 18-22 months.|Birth to 22 months corrected age|Includes all deaths and all infants followed at 18-22 months. Does not include 17 infants lost to follow up.||Participants|||Count of Participants
825844|NCT01192776|Primary|Death or Moderate to Severe Disability|Death includes any mortality prior to follow up at 18-22 months. Severe disability was defined by any of the following: a Bayley III cognitive score <70, a GMFCS level of 3-5, blindness or profound hearing loss (inability to understand commands despite amplification). Moderate disability was defined as a Bayley cognitive score of 70-84 and either a GMFCS level of 2, seizure disorder, or a hearing deficit requiring amplification to understand commands.|Birth to 22 months corrected age|Includes all deaths and all infants followed at 18-22 months. Does not include 17 infants lost to follow up.||Participants|||Count of Participants
825845|NCT01193049|Secondary|Geometric Mean Fold Change From Baseline in Nasal and Bronchial Eicosanoids and Leukotrienes at 7 Hours Post-allergen Challenge.|Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, NE and SP were collected, then prostaglandin and leukotriene concentrations were determined from NE and SP collected after 7 hours and previously at BL, to derive the FC from BL for each participant. The GM was planned to be determined by averaging FC from BL for all analyzed participants.|Baseline and 7 hours post-allergen challenge|As this same approach in a parallel study was unfruitful, these data were not pursued, and results are not presented.|||||
825846|NCT01193049|Secondary|Geometric Mean Fold Change From Baseline in Cytokines From Bronchoalveolar Lavage Fluid (BALf)|Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 23 hours had elapsed, BALf were collected, then the concentrations of IL-5, IL-13, and TARC were determined from BALf collected after 23 hours and previously at BL, to derive the FC from BL for each participant. The GM was planned to be determined by averaging FC from BL for all analyzed participants.|Baseline and 23 hours post-allergen challenge|As concentrations of cytokines were below the lower limit of quantitation this analysis was not performed, and results are not presented.|||||
825847|NCT01193049|Secondary|Geometric Mean Fold Change From Baseline in Interleukin-23 (IL-23) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge|Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, NE and SP were collected, then the concentrations of IL-23 were determined from NE and SP collected after 7 hours and previously at BL, to derive the FC from BL for each participant. The GM was plan to be determined by averaging FC from BL for all analyzed participants.|Baseline and 7 hours post-allergen challenge|As IL-23 levels were too low to detect, this analysis was not performed and results are not presented.|||||
825848|NCT01193049|Secondary|Geometric Mean Fold Change From Baseline in Thymic Stromal Lymphopoietin (TSLP) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge|Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, NE and SP were collected, then the concentrations of TSLP were determined from NE and SP collected after 7 hours and previously at BL, to derive the FC from BL for each participant. The GM was planned to be determined by averaging FC from BL for all analyzed participants.|Baseline and 7 hours post-allergen challenge|As TSLP levels were too low to detect, this analysis was not performed and results are not presented.|||||
825849|NCT01193049|Secondary|Geometric Mean Fold Change From Baseline in Macrophage Inflammatory Protein-1β (MIP-1β) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge|Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, NE and SP were collected, then the concentrations of MIP-1β were determined from NE and SP collected after 7 hours and previously at BL, to derive the FC from BL for each participant. The GM was determined by averaging FC from BL for all analyzed participants.|Baseline and 7 hours post-allergen challenge|All randomized participants||Fold Change||90% Confidence Interval|Geometric Mean
825850|NCT01193049|Secondary|Geometric Mean Fold Change From Baseline in Interleukin-1β (IL-1β) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge|Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, NE and SP were collected, then the concentrations of IL-1β were determined from NE and SP collected after 7 hours and previously at BL, to derive the FC from BL for each participant. The GM was determined by averaging FC from BL for all analyzed participants.|Baseline and 7 hours post-allergen challenge|All randomized participants||Fold Change||90% Confidence Interval|Geometric Mean
825851|NCT01193049|Secondary|Geometric Mean Fold Change From Baseline in Interleukin-17 (IL-17) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge|Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, NE and SP were collected, then the concentrations of IL-17 were determined from NE and SP collected after 7 hours and previously at BL, to derive the FC from BL for each participant. The GM was determined by averaging FC from BL for all analyzed participants.|Baseline and 7 hours post-allergen challenge|All randomized participants||Fold Change||90% Confidence Interval|Geometric Mean
826270|NCT01189136|Other Pre-specified|Pain From Treatment|Patient-reported discomfort attributable to the study intervention (0-10 Likert scale, with higher numbers representing greater pain)|30 minutes|||units on a scale||Standard Deviation|Mean
825853|NCT01193049|Secondary|Change in Vibration Response Imaging (VRI) After Metacholine Exposure|One hour before treatment with prednisone/placebo, participants inhaled for 2 minutes a nebulised solution of metacholine (0.13 ml/min); then one hour after prednisone/placebo treatment were challenged with allergens. From 1 to 7 hours after allergen challenge, ventilatory heterogeneity was assessed by Vibration Response Imaging (VRI) by monitoring the following: inspiration/expiration (I/E) amplitude ratio, I/E duration ratio, synchrony duration, and quantitative lung data.|From 1 to 7 hours post-allergen challenge|As all VRI results showed no allergen or treatment-related signals these results are not presented.|||||
825854|NCT01193049|Secondary|Geometric Mean Fold Change From Baseline in Eotaxin-3 From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge|Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, NE and SP were collected, then the concentrations of Eotaxin-3 were determined from NE and SP collected after 7 hours and previously at BL, to derive the FC from BL for each participant. The GM was determined by averaging FC from BL for all analyzed participants.|Baseline and 7 hours post-allergen challenge|All randomized participants||Fold Change||90% Confidence Interval|Geometric Mean
825855|NCT01193049|Secondary|Geometric Mean Fold Change From Baseline in Thymus and Activation Regulated Chemokine (TARC) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge|Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, NE and SP were collected, then the concentrations of TARC were determined from NE and SP collected after 7 hours and previously at BL, to derive the FC from BL for each participant. The GM was determined by averaging FC from BL for all analyzed participants.|Baseline and 7 hours post-allergen challenge|All randomized participants||Fold Change||90% Confidence Interval|Geometric Mean
825856|NCT01193049|Primary|Geometric Mean Fold Change From Baseline in Interleukin-13 (IL-13) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge|Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, NE and SP were collected, then the concentrations of IL-13 were determined from NE and SP collected after 7 hours and previously at BL, to derive the FC from BL for each participant. The GM was determined by averaging FC from BL for all analyzed participants.|Baseline and 7 hours post-allergen challenge|All randomized participants||Fold Change||90% Confidence Interval|Geometric Mean
825857|NCT01193049|Primary|Geometric Mean Fold Change From Baseline in Interleukin-5 (IL-5) Concentration From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge|Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, nasal exudates (NE) and sputum (SP) were collected, then the concentrations of IL-5 were determined from NE and SP collected after 7 hours and previously at baseline (BL), to derive the fold change (FC) from BL for each participant. The geometric mean (GM) was determined by averaging FC from BL for all analyzed participants.|Baseline and 7 hours post-allergen challenge|All randomized participants||Fold Change||90% Confidence Interval|Geometric Mean
825858|NCT01194219|Secondary|Number of Participants With a Psoriasis Flare or Rebound During the Placebo Controlled Phase|Psoriasis flare was defined as a sudden intensification of psoriasis requiring medical intervention, or a diagnosis of new generalized erythrodermic, inflammatory, or pustular psoriasis. Rebound is defined as a severe and sudden worsening of disease that occurs after treatment has been discontinued. Note categories below. [1] Psoriasis adverse events (ie, preferred term as Guttate psoriasis, Psoriasis, Pustular psoriasis) started on or after the first dose date and on or before the last dose date within the phase. [2] Psoriasis adverse events (ie, preferred term as Guttate psoriasis, Psoriasis, Pustular psoriasis, Rebound psoriasis) started after the last dose date for participants who discontinued within the phase. [3] PASI >= 125% of baseline score at any visit after the last dose date for participants who discontinued within the phase and were not included in [1] and/or [2].|Weeks 0 to Week 16|Included all participants who were randomized and received at least one dose of Investigational Product.||participants|||Number
825859|NCT01194219|Secondary|Number of Participants With Adverse Events (AE) in the Placebo Controlled Phase|An AE was any noxious, unintended, or untoward medical occurrence, that may appear or worsen in a participant during the course of study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) was considered an AE. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly or birth defect, or a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above. An AE is a treatment emergent AE if the AE start date is on or after the date of the first dose of study drug and no later than 28 days after the last dose.|Week 0 to Week 16|Safety population consisted of all participants who were randomized and received at least one dose of Investigational Product (IP)||participants|||Number
825860|NCT01194219|Secondary|Time to Loss of PASI-75 Response (Loss of Effect) at Week 32 During the Re-Randomized Treatment Withdrawal Phase|Time to loss was the time between the re-randomization date and the date of the first assessment where loss of PASI-75 was observed (event); or the time between the re-randomization date and the date of the last PASI assessment in the Weeks 32-52 interval prior to addition of protocol-prohibited medication/therapy, or resumption of APR 30 BID, or discontinuation, or Week 52 if no loss (censored).|Week 32 to Week 52|Analysis population consisted of participants who were re-randomized to placebo or apremilast 30mg BID at Week 32.||Weeks||95% Confidence Interval|Median
825875|NCT01194245|Secondary|Mean Daily Insulin Dose|Prandial insulin doses were recorded during 10-point glucose monitoring for a total of 3 days during each treatment period (3 days during Week 10 of Treatment Period 1 and 3 days during Week 22 of Treatment Period 2). The mean daily insulin dose over the 3 days during each treatment period is presented. Data is presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin Lispro from both cohorts).|Week 10 and Week 22|Participants who completed both Treatment Period 1 and Treatment Period 2 and had evaluable insulin dose data.||units (U)||Standard Deviation|Mean
831864|NCT01243411|Secondary|Change From Baseline in Penile Length|A negative value represents a reduction in measurement from baseline.|Baseline and Week 36|Efficacy is based on the mITT population.||centimeters||Standard Deviation|Mean
825861|NCT01194219|Secondary|Percentage of Participants Who Achieved Both a 75% Improvement (Response) in the PASI and sPGA Score of Clear (0) or Almost Clear (1) With at Least 2 Points Reduction From Baseline at Week 16 From Baseline|"PASI-75 response was the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. See Outcome Measure #1 for further description.
sPGA is a 5-point scale ranging from 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), to 4 (severe), incorporating an assessment of the severity of the three primary signs of the disease: erythema, scaling and plaque elevation. See OCM #2 for further description."|Baseline to Week 16|The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward imputation was used.||percentage of participants|||Number
825862|NCT01194219|Secondary|Change From Baseline in the Mental Component Summary (MSC) Score of the Medical Outcome Study Short Form 36-item (SF-36) Health Survey Version 2.0 at Week 16|"The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS).
Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value."|Baseline to Week 16|The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward imputation was used. Participants with a baseline value and at least 1 postbaseline value are included.||units on a scale||Standard Error|Least Squares Mean
825863|NCT01194219|Secondary|Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 16|DLQI is a simple, compact, and practical questionnaire for use in a dermatology clinical setting to assess limitations related to the impact of skin disease. The instrument contains ten items dealing with the participant’s skin. With the exception of Item Number 7, the participant responds on a four-point scale, ranging from “Very Much” (score 3) to “Not at All” or “Not relevant” (score 0). Item Number 7 is a multi-part item, the first part of which ascertains whether the participant’s skin prevented them from working or studying (Yes or No, scores 3 or 0 respectively), and if “No,” then the participant is asked how much of a problem the skin has been at work or study over the past week, with response alternatives being “A lot,” “A little,” or “Not at all” (scores 2, 1, or 0 respectively). The DLQI total score is derived by summing all item scores, which has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best.|Baseline to Week 16|The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward imputation was used. Participants with a baseline value and at least 1 postbaseline value are included||units on a scale||Standard Error|Least Squares Mean
825864|NCT01194219|Secondary|Change From Baseline in Pruritus Visual Analog Scale (VAS) Score at Week 16|The Pruritus Visual Analog Scores (VAS) were used to measure the amount of itching and discomfort a participant experiences. Participant's Assessment of Pruritus (Itch) asked: On average, how much itch have you had because of your condition in the past week? All VAS values range from 0 to 100. Higher scores correspond to more severe symptom or disease. Change from baseline was calculated for the VAS scale, where change = visit value − baseline value.|Baseline and Week 16|The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward imputation was used. Participants with a baseline value and at least 1 postbaseline value are included.||units on a scale||Standard Error|Least Squares Mean
825865|NCT01194219|Secondary|Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score (PASI-50) at Week 16 From Baseline|A participant was classified as having at least a 50% improvement in PASI score from baseline, which was equivalent to a percent change from baseline ranging from −100% to −50%. PASI score is based on an assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and the percent area affected as observed on the day of examination.|Baseline to Week 16|The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward imputation was used.||Percentage of Participants|||Number
825866|NCT01194219|Secondary|Percent Change From Baseline in the Psoriasis Area Severity Index (PASI) Score at Week 16|"Psoriasis Area Severity Index (PASI) scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. These values for each anatomic region are summed to yield the PASI score. The PASI score was set to missing if any severity score or degree of involvement is missing.
PASI score percent change from baseline was calculated as 100* (visit score – baseline score)/baseline score (%)."|Baseline to Week 16|The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward imputation was used. Participants with a baseline value and at least 1 postbaseline value are included .||percent change||Standard Error|Least Squares Mean
825888|NCT01194414|Secondary|Maximum Serum Concentration (Cmax) of Tocilizumab||Week 0, Week 20: at 6 hours (hr), 24 hr, 48 hr, 96 hr, 120 hr and 168 hr after dose|Pharmacokinetic-Evaluable Population included all participants who provided at least one evaluable PK sample were included in the PK analysis. Here, number of participants analyzed who were evaluable for this outcome measure and ‘n’ indicates number of participants who were evaluated at specified time point.||mcg/mL||Standard Deviation|Mean
825867|NCT01194219|Secondary|Percent Change From Baseline in Percent of Affected Body Surface Area (BSA) at Week 16|"BSA was a measurement of involved skin. The overall BSA affected by psoriasis was estimated based on the palm area of the participant’s hand (entire palmar surface or “handprint” including the fingers), which equates to approximately 1% of total body surface area.
BSA percent change from baseline (Visit 2 Week 0) was determined at each visit of the study, which is calculated as 100*(visit BSA – baseline BSA) / baseline BSA (%)."|Baseline and Week 16|The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Participants with a baseline value and at least 1 postbaseline value were included. Last observation carried forward imputation was used.||percent change||Standard Error|Least Squares Mean
825868|NCT01194219|Secondary|Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of Clear (0) or Almost Clear (1) With at Least 2 Points Reduction From Baseline|The sPGA was a 5-point scale ranging from 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), to 4 (severe), incorporating an assessment of the severity of the three primary signs of the disease: erythema, scaling and plaque elevation. When making the assessment of overall severity, the Investigator factored in areas that have already been cleared (ie, have scores of 0) and did not just evaluate remaining lesions for severity, ie, the severity of each sign was averaged across all areas of involvement, including cleared lesions. In the event of different severities across disease signs, the sign that is the predominant feature of the disease should be used to help determine the sPGA score.|Baseline to Week 16|The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward imputation was used.||percentage of participants|||Number
825869|NCT01194219|Primary|Percentage of Participants Who Achieved a 75% Improvement (Response) in the Psoriasis Area Severity Index (PASI-75) at Week 16 From Baseline|PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The PASI score was set to missing if any severity score or degree of involvement is missing.|Baseline to Week 16|The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward (LOCF) imputation was used.||percentage of participants|||Number
825870|NCT01194245|Secondary|Mean Daily Postprandial Glucose (PPG) Excursions|Participants performed 10-point glucose monitoring for a total of 3 days during each treatment period (3 days during Week 10 of Treatment Period 1 and 3 days during Week 22 of Treatment Period 2). Mean daily postprandial plasma glucose (PPG) excursions (referring to the change in blood glucose levels from before to after a meal) during 10-point glucose monitoring for breakfast, lunch, and dinner are presented. Data were collected 1 and 2 hours (hr) after each meal for 3 days and the means of each excursion are presented.|Week 10 and Week 22|Participants who completed both Treatment Period 1 and Treatment Period 2 and had evaluable postprandial glucose (PPG) excursion data.||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
825871|NCT01194245|Secondary|Change From Baseline in Body Weight at the End of Each Treatment Period|Body weight was measured at baseline (Week 0) and at the end of each treatment period (Week 12 and Week 24). Data is presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin Lispro from both cohorts).|Baseline, Week 12 and Week 24|Participants who completed both Treatment Period 1 and Treatment Period 2 and had evaluable body weight data.||pounds (lbs)||Standard Deviation|Mean
825872|NCT01194245|Primary|Change From Baseline in Glycosylated Hemoglobin A1C (HbA1c) at the End of Each Treatment Period|Glycosylated hemoglobin A1C (HBA1c) levels were measured at baseline (Week 0) and at the end of each treatment period (Week 12 and Week 24). Data are presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin Lispro from both cohorts). Least Squares (LS) means were calculated from mixed effects linear models with treatment (Lispro, Aspart), recombinant human hyaluronidase PH20 (rHuPH20; yes, no), and treatment sequence as fixed effects and participant within treatment sequence as a random effect.|Baseline, Week 12 and Week 24|Participants who completed both Treatment Period 1 and Treatment Period 2 and had evaluable hemoglobin A1C data.||percentage of hemoglobin A1C||Standard Deviation|Mean
825873|NCT01194245|Secondary|Rates of Hypoglycemia at the End of Each Treatment Period|Overall rates of hypoglycemia (blood glucose ≤70 milligrams per deciliter [mg/dL] and <56 mg/dL) were calculated based on 4 weeks of observation for each treatment period. Data is presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin Lispro from both cohorts). A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Week 12 and Week 24|Participants who completed both Treatment Period 1 and Treatment Period 2.||events per participant per month|||Number
825874|NCT01194245|Secondary|Percentage of Participants Meeting Glucose Targets|Participants were instructed to monitor their blood glucose levels a minimum of 4 times per day on all non-10-point glucose monitoring days. The number of participants meeting 90-minute postprandial plasma glucose (PPG) targets of <140 and <180 milligrams per deciliter (mg/dL) for at least 2/3 of values during non-10-point glucose monitoring days was recorded. The percentage was calculated by dividing the number of participants with values meeting the specified target at least 2/3 of the time by the total number of participants analyzed, multiplied by 100. Data is presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin Lispro from both cohorts).|Baseline through Week 24, excluding 10-point glucose monitoring days|Participants who completed both Treatment Period 1 and Treatment Period 2 and had evaluable postprandial glucose data.||percentage of participants|||Number
829233|NCT01225354|Secondary|Subject First Impression|Each subject will complete the 10-point (1-Not at all to 10-Very Much) evaluating their own first impression at Baseline, Visit 2 (if applicable), Visit 3, and Visit 4.|baseline, Visit 2, Visit3, and Visit 4||12/2013||||
825876|NCT01194258|Secondary|Mean Daily PPG Excursions|Participants performed 10-point glucose monitoring for a total of 3 days during each treatment period (3 days during Week 10 of Treatment Period 1 and 3 days during Week 22 of Treatment Period 2). Mean daily PPG excursions during 10-point glucose monitoring for breakfast, lunch, and dinner from Treatment Period 1 or Treatment Period 2 are presented. PPG refers to the change in glucose concentration before to after a meal. Data were collected 1 and 2 hours (hr) after each meal. Data are presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (insulin lispro from both cohorts).|Week 10 and Week 22|All participants who completed both Period 1 and Period 2 with evaluable PPG excursion data.||mg/dL||Standard Deviation|Mean
825877|NCT01194258|Secondary|Change From Baseline in Body Weight at the End of Each Treatment Period|Change from baseline in body weight at the end of each treatment period (Week 12 and Week 24) is presented. Data are presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin lispro from both cohorts).|Baseline, Week 12 and Week 24|All participants who completed both Period 1 and Period 2 with evaluable body weight data.||pounds||Standard Deviation|Mean
825878|NCT01194258|Secondary|Rates of Hypoglycemia at the End of Each Treatment Period|The rate of hypoglycemia, defined as blood glucose levels ≤70 mg/dL and <56 mg/dL, was calculated based on 4 weeks of observation prior to the end of treatment period (that is, Week 12 and Week 24). Data are presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin lispro from both groups). A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.|Week 12 and Week 24|All participants who completed both Treatment Period 1 and Treatment Period 2.||Events per participant per month|||Number
825879|NCT01194258|Secondary|Percentage of Participants Meeting Glucose Targets at Least 2/3 of the Time|Participants were instructed to monitor their blood glucose levels a minimum of 4 times per day on all non-10-point glucose monitoring days. The number of participants meeting 90-minute postprandial plasma glucose (PPG) targets of <140 and <180 milligrams per deciliter (mg/dL) for at least 2/3 of values was recorded during non-10-point glucose monitoring was recorded. The number of participants was recorded, and the percentage of participants meeting glucose targets was calculated by the number of participants with values meeting the specified target at least 2/3 of the time by the total number of participants analyzed, multiplied by 100. Data is presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin Lispro from both cohorts).|Baseline through Week 24, excluding 10-point glucose monitoring days|Participants in Treatment Period 1 or Treatment Period 2 who received at least 1 dose of study drug and had evaluable postprandial blood glucose data.||Percentage of participants|||Number
825880|NCT01194258|Secondary|Mean Daily Insulin Dose as Recorded During 10-Point Glucose Monitoring|Mean daily insulin dose as recorded during 10-point glucose monitoring is reported. Blood glucose values were obtained during a total of 3 days during each treatment period (3 days during Week 10 of Treatment Period 1 and 3 days during Week 22 of Treatment Period 2) at the following timepoints: immediately prior to breakfast (fasting), 1 hour (hr) after breakfast, 2 hr after breakfast, immediately prior to lunch, 1 hr after lunch, 2 hr after lunch, immediately prior to dinner, 1 hr after dinner, 2 hr after dinner, and at 03:00. A minimum of 7 determinations were required for each day during the 3 days of 10-point glucose profiles. Prandial insulin doses were also recorded during the 10-point glucose monitoring and the mean daily insulin dose over the 3 days was calculated. Data are presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin Lispro from both cohorts).|Week 10 and Week 22|All participants who completed both Treatment Period 1 and Treatment Period 2 with evaluable insulin dosing data.||units of Insulin||Standard Deviation|Mean
825881|NCT01194258|Primary|Change From Baseline in Glycosylated Hemoglobin A1C (HbA1C) at the End of Each Treatment Period|Change in glycosylated hemoglobin A1C (HbA1C) from baseline (Week 0) to end of treatment period (Week 12 and Week 24) is presented. Data are presented by combined treatment group (Lispro-recombinant human hyaluronidase PH20 (PH20) + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin lispro from both groups). Least squares (LS) means were calculated from linear contrasts of mixed effects linear models with treatment (Lispro, Aspart), PH20 (yes, no), and treatment sequence as fixed effects and participant within treatment sequence as a random effect.|Baseline, Week 12 and Week 24|All participants who completed both Treatment Period 1 and Treatment Period 2 with evaluable HbA1C data.||percentage of HbA1C||Standard Deviation|Mean
825882|NCT01194297|Secondary|Medically-attended Wheezing|Wheezing that triggers a visit for medical care|42 days|Total N||participants|||Number
825883|NCT01194297|Primary|Humoral Immunogenicity|Hemagglutinin specific antibody, as measured by hemagglutination inhibition|28-42 days||||||
825884|NCT01194414|Secondary|Percentage of Participants Who Developed Antibodies To Tocilizumab at Week 97||Week 97|The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Here, 'n' indicates number of subjects in the safety population tested by screening assay at any time point.||percentage of participants|||Number
825885|NCT01194414|Secondary|Change From Baseline in Serum Soluble Interleukin-6 Receptor (sIL-6R) Concentration at Week 97||Baseline, Week 97|The ITT-PK population includes all participants who were eligible for the ITT population and provided at least 1 evaluable PK sample in the double blind or open label periods. Here, number of participants analyzed who were evaluable for this outcome measure and ‘n’ indicates number of participants who were evaluated at specified time point.||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
825886|NCT01194414|Secondary|Change From Baseline in Serum Interleukin-6 (IL-6) Concentration at Week 25||Baseline, Week 25|The ITT-PK population includes all participants who were eligible for the ITT population and provided at least 1 evaluable PK sample in the double blind or open label periods. Here, number of participants analyzed who were evaluable for this outcome measure and ‘n’ indicates number of participants who were evaluated at specified time point.||picogram/milliliter (pg/mL)||Standard Deviation|Mean
825887|NCT01194414|Secondary|Time to Maximum Serum Concentration (Tmax) of Tocilizumab||Week 0, Week 20: at 6 hours (hr), 24 hr, 48 hr, 96 hr, 120 hr and 168 hr after dose|Pharmacokinetic-Evaluable Population included all participants who provided at least one evaluable PK sample were included in the PK analysis. Here, number of participants analyzed who were evaluable for this outcome measure and ‘n’ indicates number of participants who were evaluated at specified time point.||hour (hr)||Full Range|Median
825889|NCT01194414|Secondary|Minimum Serum Concentration (Cmin) of Tocilizumab||Week 0, Week 20: at 6 hours (hr), 24 hr, 48 hr, 96 hr, 120 hr and 168 hr after dose|Pharmacokinetic-Evaluable Population included all participants who provided at least one evaluable PK sample were included in the PK analysis. Here, number of participants analyzed who were evaluable for this outcome measure and ‘n’ indicates number of participants who were evaluated at specified time point.||micrgram/milliliter (mcg/mL)||Standard Deviation|Mean
825890|NCT01194414|Secondary|Area Under the Serum Concentration Curve of Tocilizumab at Steady State for SC and IV Treatment||Week 20: at 6 hours (hr), 24 hr, 48 hr, 96 hr, 120 hr and 168 hr after dose.|Pharmacokinetic-Evaluable Population included all participants who provided at least one evaluable PK sample were included in the pharmacokinetic analysis (PK) analysis. Here, number of participants analyzed who were evaluable for this outcome measure.||μg*hr/mL||Standard Deviation|Mean
825891|NCT01194414|Secondary|Area Under the Serum Concentration Curve of Tocilizumab After First SC Injection or IV Infusion||Week 0: at 6 hours (hr), 24 hr, 48 hr, 96 hr, 120 hr and 168 hr after first dose|Pharmacokinetic-Evaluable Population included all participants who provided at least one evaluable PK sample were included in the pharmacokinetic analysis (PK) analysis. Here, number of participants analyzed who were evaluable for this outcome measure.||microgram*hour/milliliter (mcg*hr/mL)||Standard Deviation|Mean
825892|NCT01194414|Secondary|Percentage of Participants Who Withdrew Because of Lack of Therapeutic Response at Week 97|The percentage of participants who withdrew from the study because they were not responding to treatment with the study drug.|Week 97|ITT Population included all participants who completed double blind period and were re-randomized at Week 24 and received at least one dose of study drug.||percentage of participants|||Number
825893|NCT01194414|Secondary|Percentage of Participants Achieving a Decrease of ≥0.3 in the Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline to Week 97|The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0(without any difficulty) to 4 (unable to do).HAQ-DI=sum of worst scores in each domain divided by the number of domains answered. A decrease indicates improvement. No imputation of missing scores was made other than for missing baseline scores, for which last score prior to baseline will be carried forward. For participants who prematurely withdrew, data collected at withdrawal visit was used and data thereafter is missing.|Baseline, Week 97|ITT Population included all participants who completed double blind period and were re-randomized at Week 24 and received at least one dose of study drug. Here, number of participants analyzed is the participants for whom parameter was collected.||percentage of participants|||Number
825894|NCT01194414|Secondary|Percentage of Participants With Disease Activity Score 28 (DAS28) Remission at Week 97|The DAS28 (ESR) score is a measure of the subject's disease activity. It is calculated using the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity VAS where left side of the line 0=no disease activity to right side of the line 100=extreme disease activity and ESR. DAS28-(ESR) total scores range from 0 - 10. Remission is defined as achieving a DAS28-ESR score of less than 2.6. LOCF used for tender and swollen joint counts, no imputation used for ESR and Patient's Global Assessment of Disease Activity VAS.|Week 97|ITT Population included all participants who completed double blind period and were re-randomized at Week 24 and received at least one dose of study drug. If ESR=0 then ESR=1 is substituted into the DAS28 calculation to enable a non-missing DAS28 score. Here, number of participants analyzed is the participants for whom parameter was collected.||percentage of participants|||Number
825895|NCT01194414|Secondary|Percentage of Participants With American College of Rheumatology Criteria (ACR20, ACR50, ACR70) at Week 97|ACR20, ACR50 and ACR70: ≥20%, ≥50% and ≥70% reduction from baseline for both TJC68 and SJC66, as well as for 3 of 5 additional ACR variables: Patient's Assessment of Pain in last 24 hours using a Visual Analog Scale (VAS) (0=no pain and 100=unbearable pain); Patient's and Physician's Global Assessment of Disease Activity in last 24 hours using a VAS (0=no disease activity and100=maximum disease activity); Health Assessment Questionnaire: 20 questions in 8 areas (dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities) answered on a scale of 0=without difficulty to 3=unable to do; and acute-phase reactant (either CRP or ESR). CRP was used for calculation of ACR. If missing, ESR was used. LOCF was used for missing joint counts, no imputation for other ACR components.|Week 97|Re-Randomized Intent-to-Treat Population (ITT Population) included all participants who completed double blind period and were re-randomized at Week 24, received at least 1 dose of study drug. Here, number of participants analyzed is the participants for whom parameter was collected.||percentage of participants|||Number
825896|NCT01194414|Secondary|Percentage of Participants Who Withdrew Because of Lack of Therapeutic Response at Week 24|The percentage of participants who withdrew from the study because they were not responding to treatment with the study drug.|24 Weeks|Per Protocol Population included all randomized participants who received study drug and had no major protocol violations.||Percentage of participants|||Number
825897|NCT01194414|Secondary|Percentage of Participants Achieving a Decrease of ≥ 0.3 in the Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline to Week 24|The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a participant completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0(without any difficulty) to 4 (unable to do).HAQ-DI=sum of worst scores in each domain divided by the number of domains answered. A decrease indicates improvement.|Baseline, 24 Weeks|Participants from the Per Protocol Population (all randomized participants who received study drug and had no major protocol violations) with data available for analysis. No imputation of missing scores will be made other than for missing baseline scores, for which last score prior to defined protocol baseline time window will be carried forward.||Percentage of participants|||Number
825910|NCT01194479|Primary|Norepinephrine (pg/mL)|Norepinephrine levels will be measured throughout the study to assess whether there are changes during hypoglycemia with inhaled formoterol. These levels will be checked every 20 minutes during the 120 minute study session. Results are presented at the Basal, Euglycemia (30 minutes) and Hypoglycemia (105-120 minutes) stages|up to 120 minutes|Results are pooled at the arm level and split by placebo and control regardless of randomization order.||pg/mL||Standard Error|Mean
825898|NCT01194414|Secondary|Percentage of Participants With Disease Activity Score 28 (DAS28) Remission at Week 24|The DAS28 (ESR) score is a measure of the subject's disease activity. It is calculated using the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity VAS where left side of the line 0=no disease activity to right side of the line 100=extreme disease activity and ESR. DAS28-(ESR) total scores range from 0 - 10. Remission is defined as achieving a DAS28-ESR score of less than 2.6.|Week 24|Participants from the Per Protocol Population (randomized participants who received study drug and had no major protocol violations) with data available for analysis. Missing SJC and TJC will be imputed using the last post-baseline value for the patient (LOCF). No imputation for missing ESR or patient’s global assessment of disease activity.||Percentage of participants|||Number
825899|NCT01194414|Secondary|Percentage of Participants Achieving an American College of Rheumatology Criteria (ACR70) Response at Week 24|ACR70 response is defined as a ≥ 70% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the five additional ACR core set variables: Patient's Assessment of Pain over the previous 24 hours using a Visual Analog Scale (VAS) where left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions in 8 areas (dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities) answered on a scale of 0=without difficulty to 3=unable to do; and acute-phase reactant (either C-reactive protein or Erythrocyte Sedimentation Rate).|Baseline, 24 weeks|Per Protocol Population included all randomized participants who received study drug and had no major protocol violations. Last Observation Carried Forward was used for missing joint counts, no imputation for other ACR components. CRP will be used primarily for calculation of the ACR response. If missing, the ESR will be used for that participant.||Percentage of participants|||Number
825900|NCT01194414|Secondary|Percentage of Participants Achieving an American College of Rheumatology Criteria (ACR50) Response at Week 24|ACR50 response is defined as a ≥ 50% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the five additional ACR core set variables: Patient's Assessment of Pain over the previous 24 hours using a Visual Analog Scale (VAS) where left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions in 8 areas (dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities) answered on a scale of 0=without difficulty to 3=unable to do; and acute-phase reactant (either C-reactive protein or Erythrocyte Sedimentation Rate).|Baseline, 24 weeks|Per Protocol Population included all randomized participants who received study drug and had no major protocol violations. Last Observation Carried Forward was used for missing joint counts, no imputation for other ACR components. CRP will be used primarily for calculation of the ACR response. If missing, the ESR will be used for that participant.||Percentage of participants|||Number
825901|NCT01194414|Primary|Percentage of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Assessments||Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)|The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.||percentage of participants|||Number
825902|NCT01194414|Primary|Percentage of Participants Achieving an American College of Rheumatology Criteria (ACR20) Response at Week 24|ACR20 response is defined as a ≥ 20% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the five additional ACR core set variables: Patient's Assessment of Pain over the previous 24 hours using a Visual Analog Scale (VAS) where left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions in 8 areas (dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities) answered on a scale of 0=without difficulty to 3=unable to do; and acute-phase reactant (either C-reactive protein [CRP] or Erythrocyte Sedimentation Rate [ESR]).|Baseline, 24 weeks|Per Protocol Population included all randomized participants who received study drug and had no major protocol violations. Last Observation Carried Forward was used for missing joint counts, no imputation for other ACR components. CRP will be used primarily for calculation of the ACR response. If missing, the ESR will be used for that participant.||Percentage of participants||95% Confidence Interval|Number
825903|NCT01194427|Primary|Changes in Markers of Proliferation Prior to and After Study Drug Administration|To determine the percentage change in proliferation index Ki-67 in both ER-positive and ER-negative tumors between baseline and post-treatment biopsy following 14 days of vorinostat 400 mg PO once daily and tamoxifen 20mg PO once daily in women with primary breast cancer awaiting definitive surgery.|Baseline and 14 days|Two (2) participants were enrolled; however, due to difficulty in recruitment, we were not able to complete the study. There were not study-specific analyses completed or results to report.|||||
825904|NCT01194440|Secondary|Number of Patients Who Discontinue or Change Aromatase Inhibitory (AI) Therapy||12 months||||||
825905|NCT01194440|Secondary|Visual Analog Scale||12 months||||||
825906|NCT01194440|Secondary|Health Assessment Questionnaire Disability Index||12 months||||||
825907|NCT01194440|Primary|Frequency of Women With Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS)|The primary hypothesis of the study is that given zoledronic acid with letrozole would result in a significant decline in the percentage of women experiencing AIMSS as compared to patients receiving letrozole alone. The number of women experiencing AIMSS in this study is compared to the results from a prior published study of women receiving letrozole alone.|12 months|||Participants|||Count of Participants
825908|NCT01194453|Secondary|Response Rate||6 weeks|||percentage|||Number
825909|NCT01194453|Primary|Progression Free Survival (PFS)||36months|||day||95% Confidence Interval|Median
825913|NCT01194479|Primary|Glucagon (pg/mL)|Glucagon levels will be measured throughout the study to assess whether there are changes during hypoglycemia with inhaled formoterol. These levels will be checked every 20 minutes during the 120 minute study session. Results are presented at the Basal, Euglycemia (30 minutes) and Hypoglycemia (105-120 minutes) stages.|up to 120 minutes|Results are pooled at the arm level and split by placebo and control regardless of randomization order.||pg/mL||Standard Error|Mean
825914|NCT01194531|Primary|Implantation Rate|Implantation rate is defined as the ratio between the number of gestational sacs with a fetal heartbeat and the total number of embryos transferred.|Data is collected at approximately 4-6 weeks gestation, 20 weeks gestation and 40 weeks gestation.|Patients who reached embryo transfer were included in this analysis.||percentage of implantation per group|||Number
825915|NCT01194674|Secondary|Change in Retino-vascular Leakage, as Seen on Fluorescein Angiography (FA), at 4 Weeks vs. Baseline|"Retino-vascular leakage was calculated after manually outlining the inner and outer borders of the subretinal fluid packet in the optical coherence tomography (OCT) images using the Edit Segmentation function of the Cirrus HD-OCT software. For cases in which a pigment epithelial detachment was present, the volume of the pigment epithelial detachment was included in the calculation of leakage volume."|Baseline and 4 weeks||||||
825916|NCT01194674|Primary|Number of Non-ocular Adverse Events|The number of adverse events that were not eye-related was calculated.|24 weeks|||Adverse Events|||Number
825917|NCT01194674|Primary|Number of Ocular Adverse Events|The number of eye-related adverse events was calculated.|24 weeks|||Adverse Events|||Number
825918|NCT01194674|Primary|Number of Severe Adverse Events||24 weeks|||Adverse Events|||Number
825919|NCT01194674|Secondary|Change in ETDRS Best-corrected Visual Acuity (BCVA) at 12 Weeks vs. Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 12 Weeks||||||
825920|NCT01194674|Secondary|Change in ETDRS Best-corrected Visual Acuity (BCVA) at 4 Weeks vs. Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 4 weeks||||||
825921|NCT01194674|Secondary|Number of Participants Achieving Macular or Complete Posterior Vitreous Detachment (PVT) at 4 Weeks||Baseline and 4 weeks||||||
825922|NCT01194674|Secondary|Change in Central Macular Thickness, as Measured by Optical Coherence Tomography (OCT), at 4 Weeks vs. Baseline|Retinal thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|Baseline and 4 weeks||||||
825923|NCT01194674|Primary|Number of Adverse Events||24 weeks|||Adverse Events|||Number
825924|NCT01194830|Secondary|Change From Baseline in 2-hour Post-prandial Glucose (PPG) After 24 Weeks||baseline, 24 weeks|Meal Tolerance Test, observed cases data set (MTT-OC) includes all randomized patients who participated in the MTT sub-study. Patients required to have both baseline and on-treatment results.||mg/dL (milligrams per deciliter)||Standard Error|Least Squares Mean
825925|NCT01194830|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks||baseline, 24 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline FPG value and an on-treatment FPG value.||mg/dL (milligrams per deciliter)||Standard Error|Least Squares Mean
825926|NCT01194830|Secondary|Occurrence of Relative Efficacy Response (Reduction in HbA1c >= 0.5%) After 24 Weeks|Glycosylated hemoglobin is reported as a percentage of the total hemoglobin|24 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication.||Participants|||Number
825927|NCT01194830|Secondary|Occurrence of Absolute Efficacy Response (HbA1c < 6.5%) After 24 Weeks|Glycosylated hemoglobin is reported as a percentage of the total hemoglobin|24 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication.||Participants|||Number
825928|NCT01194830|Secondary|Occurrence of Absolute Efficacy Response (HbA1c < 7%) After 24 Weeks|Glycosylated hemoglobin is reported as a percentage of the total hemoglobin|24 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication.||Participants|||Number
825929|NCT01194830|Secondary|Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 18 Weeks|Glycosylated hemoglobin is reported as a percentage of the total hemoglobin|baseline, 18 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline HbA1c value and an on-treatment HbA1c value. Four subjects in each arm excluded for site non-compliance.||Percentage||Standard Error|Least Squares Mean
825930|NCT01194830|Secondary|Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 12 Weeks|Glycosylated hemoglobin is reported as a percentage of the total hemoglobin|baseline, 12 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline HbA1c value and an on-treatment HbA1c value. Four subjects in each arm excluded for site non-compliance.||Percentage||Standard Error|Least Squares Mean
825931|NCT01194830|Secondary|Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 6 Weeks|Glycosylated hemoglobin is reported as a percentage of the total hemoglobin|baseline, 6 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline HbA1c value and an on-treatment HbA1c value. Four subjects in each arm excluded for site non-compliance.||Percentage||Standard Error|Least Squares Mean
825932|NCT01194830|Primary|Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 24 Weeks|Glycosylated hemoglobin is reported as a percentage of the total hemoglobin|baseline, 24 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline HbA1c value and an on-treatment HbA1c value. Four subjects in each arm excluded for site non-compliance.||Percentage||Standard Error|Least Squares Mean
825933|NCT01194856|Secondary|Correlate the Changes in DEXA-measured Fat Limb With Fat mtDNA, mtRNA and Fat Apoptosis|A secondary objective of this trial will be to correlate the changes in DEXA-measured limb fat with those of fat mtDNA, mtRNA levels and fat apoptosis|96 weeks|Data not collected for analysis due to low enrollment and participant discontinuation.|||||
825934|NCT01194856|Secondary|Compare Changes in Levels of Hs-CRP Between the Two Arms|To examine the effect of switching from EFV to ATV/r on highly sensitive C-reactive protein (hs-CRP) in HIV-1 infected patients, a secondary objective of this trial will be to compare changes over 96 weeks in hs (highly sensitive) - CRP levels between the EFV arm and the ATV/r arm.|96 weeks|Data not collected for analysis due to low enrollment and participant discontinuation.|||||
825935|NCT01194856|Secondary|Comparing Glucose Metabolism (Fasting Insulin, QUIKI and HOMA-IR) Between the Two Arms|To examine the effect of switching from EFV to ATV/r on glucose metabolism in HIV-1 infected patients, a secondary objective of this trial will be to compare changes over 96 weeks in fasting insulin, QUIKI and HOMA-IR between the EFV arm and the ATV/r arm|96 weeks|Data not collected for analysis due to low enrollment and participant discontinuation.|||||
825936|NCT01194856|Secondary|Comparing Fasting Lipid Levels Between the Two Arms|To examine the effect of switching from EFV to ATV/r on lipids in HIV-1 infected patients, a secondary objective of this trial will be to compare changes over 96 weeks in fasting lipid levels between the EFV arm and ATV/r arm.|96 weeks|Data not collected for analysis due to low enrollment and participant discontinuation.|||||
825937|NCT01194856|Secondary|Compare Changes in Fat mtDNA, mtRNA and Fat Apoptosis Between the Two Arms|To examine the effect of switching from EFV to ATV/r on fat mtDNA, mtRNA, and fat apoptosis in HIV-1 infected patients, a secondary objective of this trial will be to compare changes over 96 weeks in fat mtDNA, mt RNA levels and fat apoptosis between the EFV arm and ARV/r arm.|96 weeks|Data not collected for analysis due to low enrollment and participant discontinuation.|||||
825938|NCT01194856|Secondary|Compare Changes in CD4, HIV-1 RNA Levels and Adverse Events in Two Arms|To examine the effect of switching from EFV to ATV/r on safety in HIV-1 infected patients, a secondary objective of this trial will be to compare changes over 96 weeks in CD4 cell count, HIV-1 RNA levels, and adverse events between the EFV arm and the ATV/r arm|96 weeks|Data not collected for analysis due to low enrollment and participant discontinuation.|||||
825939|NCT01194856|Secondary|Compare Changes for DEXA-measured Limb Fat Between EFV and ATV/r Arms|To examine the effect of switching from EFV- to ATV/r on limb fat in HIV-1 infected patients with established lipoatrophy, a secondary objective of this trial will be to compare changes over 96 weeks in DEXA-measured limb fat between the EFV arm and ARV/r.|96 weeks|Data not collected for analysis due to low enrollment and participant discontinuation.|||||
825940|NCT01194856|Primary|Change in DEXA-measured Limb Fat Between the EFV and ATV/r Arms|To examine the effect of switching from EFV- to ATV/r on limb fat in HIV-1 infected patients with established lipoatrophy, the primary objective of this trial will be to compare changes over 48 weeks in DEXA-measured limb fat between the EFV arm and ATV/r.|48 weeks|Data not collected for analysis due to low enrollment and participant discontinuation.|||||
825941|NCT01194869|Secondary|Clinical Response Rate (Complete Pathologic Response Rate After Surgery)|Pathologic complete response (pCR): Absence of invasive breast cancer in the breast (mastectomy or lumpectomy) specimen during follow-up. Presence of in situ cancer alone will be considered a pCR but may be recorded separately.|Up to 2 years after definitive surgery|||participants|||Number
825942|NCT01194869|Secondary|Clinical Response Rate During Follow-up (Disease Recurrence)|Response will be assessed according to World Health Organization criteria with progressive disease (PD) defined as a 25% or greater increase in a single lesion, OR reappearance of any lesion which has disappeared, OR clear worsening of any evaluable disease OR appearance of any new lesion/site.|Up to 2 years after definitive surgery|||participants|||Number
825943|NCT01194869|Primary|Pathologic Complete Response (pCR) at the Time of Surgery After Preoperative Treatment|Pathologic complete response (pCR): Absence of invasive breast cancer in the breast (mastectomy or lumpectomy) specimen at the time of definitive surgery. Presence of in situ cancer alone will be considered a pCR but may be recorded separately.|At the time of surgery, after 24 weeks of preoperative treatment|||participants|||Number
825944|NCT01194908|Secondary|To Determine the Safety of Tamoxifen in Combination With Decitabine and LBH589||Patients will undergo an evaluation for extent of disease 8 weeks from starting study drugs and every 8 weeks (2 cycles) while on study.|No data were analyzed due to trial termination.|||||
825945|NCT01194908|Primary|To Determine the Maximum Tolerated Dose of Decitabine and LBH589 Given in Combination in Patients With Metastatic or Locally Advanced Metastatic Breast Cancers||Estrogen receptor status checked 5 days after treatment. Staging is done every 8 weeks.|No data were analyzed due to trial termination.|||||
825946|NCT01194973|Secondary|Platelet Count Change From Baseline to 52 Weeks||Through 52 Weeks|Change from baseline platelet counts were analyzed for the ITT population using a repeated measures ANOVA model. The estimated LS means of change from baseline at each post-baseline visit alongside with 95% CIs and P-values were calculated, as were the parameter estimates for the covariates and their associated P-values.||10^9 cells/L||95% Confidence Interval|Least Squares Mean
825947|NCT01194973|Secondary|Percentage of Patients With Estimated Glomerular Filtration Rate (eGFR) Improvement|Proportion of Patients with Estimated Glomerular Filtration Rate (eGFR) Improvement was determined and defined as an increase in eGFR by ≥ 15 mL/min/1.73m^2 from baseline sustained for at least two consecutive measurements obtained at least four weeks apart|Through End of Study, Median Exposure 52 Weeks|The tabulations of the proportions of patients with Estimated Glomerular Filtration Rate (eGFR) Improvement through end of study were performed for the ITT population. The number of patients with response and responder rate, along with an exact two-sided 95% CI were summarized for each parameter.||Percentage of Participants||95% Confidence Interval|Number
825948|NCT01194973|Secondary|Percentage of Patients With Platelet Count Normalization|Proportion of Patients with Platelet Count Normalization through end of study of treatment was determined and defined as the platelet count observed to be ≥ 150 x 109/L on at least two consecutive measurements which span a period of at least four weeks|Through End of Study, Median Exposure 52 Weeks|The tabulations of the proportions of patients with Platelet Count Normalization through end of study were performed for the ITT population. The number of patients with response and responder rate, along with an exact two-sided 95% CI were summarized.||Percentage of Participants||95% Confidence Interval|Number
825960|NCT01195025|Secondary|Variation of Coagulation Factors and Plasma Proteins During and After Infusion of Crystalloid and Colloid Solutions.|The investigators will measure a few markers of coagulation (fibrinogen, thrombocytes, D-Dimer, PK-INR, aPTT, and coagulation factor VII) as well as Cystatin C, serum albumine and hemoglobin and how the concentration of these vary with the different dilutions of blood during and after infusion of a colloid and/or a crystalloid solution.|420 minutes||05/2015||||
825949|NCT01194973|Secondary|Percentage of Patients With Complete Hematologic Response|Proportion of Patients with Complete Hematologic response through end of study of treatment was determined and defined by normalization of platelet count and LDH sustained for at least two consecutive measurements obtained at least four weeks apart.|Through End of Study, Median Exposure 52 Weeks|The tabulations of the proportions of patients with Complete Hematologic Response through end of study were performed for the ITT population. The number of patients with response and responder rate, along with an exact two-sided 95% CI were summarized.||Percentage of Participants||95% Confidence Interval|Number
825950|NCT01194973|Secondary|Percentage of Patients With Modified Complete TMA Response|Proportion of Patients with Modified Complete TMA response through end of study was determined and defined by normalization of hematological parameters (platelet count and LDH) and improvement in renal function (defined as ≥ 25% reduction from the baseline value in serum creatinine, which were sustained for at least two consecutive measurements obtained at least four weeks apart.|Through End of Study, Median Exposure 52 Weeks|The tabulations of the proportions of patients with Modified Complete TMA Response through end of study were performed for the ITT population. Exact binomial two-sided 95% CI using the Clopper-Pearson method for the responder rate was presented.||Percentage of Participants||95% Confidence Interval|Number
825951|NCT01194973|Secondary|Percentage of Patients With Complete TMA Response|Proportion of Patients with Complete TMA response through end of study was determined and defined by normalization of hematological parameters (platelet count and LDH) and preservation of renal function (defined as < 25% increase in serum creatinine from baseline) which were sustained for at least two consecutive measurements obtained at least four weeks apart.|Through End of Study, Median Exposure 52 Weeks|The tabulations of the proportions of patients with Complete TMA Response through end of study were performed for the ITT population. Exact binomial two-sided 95% CI using the Clopper-Pearson method for the responder rate was presented.||Percentage of Participants||95% Confidence Interval|Number
825952|NCT01194973|Secondary|Platelet Count Change From Baseline to 26 Weeks||Through 26 weeks|Change from baseline platelet counts were analyzed for the ITT population using a repeated measures Analysis of variance (ANOVA) model. The estimated LS means of change from baseline at each post-baseline visit alongside with 95% CIs and P-values were calculated, as were the parameter estimates for the covariates and their associated P-values.||10^9 cells/L||95% Confidence Interval|Least Squares Mean
825953|NCT01194973|Secondary|Percentage of Patients With Estimated Glomerular Filtration Rate (eGFR) Improvement|Proportion of Patients with Estimated Glomerular Filtration Rate (eGFR) Improvement was determined and defined as an increase in eGFR by ≥ 15 mL/min/1.73m^2 from baseline, sustained for at least two consecutive measurements obtained at least four weeks apart.|Through 26 weeks|The tabulations of the proportions of patients with Estimated Glomerular Filtration Rate (eGFR) Improvement through 26 weeks were performed for the ITT population. The number of patients with response and responder rate, along with an exact two-sided 95% CI were summarized.||Percentage of Participants||95% Confidence Interval|Number
825954|NCT01194973|Secondary|Percentage of Patients With Platelet Count Normalization|Proportion of Patients with Platelet Count Normalization through 26 weeks of treatment was determined and defined as the platelet count observed to be ≥ 150 x 109/L on at least two consecutive measurements which span a period of at least four weeks|Through 26 weeks|The tabulations of the proportions of patients with Platelet Count Normalization through 26 weeks were performed for the ITT population. The number of patients with response and responder rate, along with an exact two-sided 95% CI were summarized.||Percentage of Participants||95% Confidence Interval|Number
825955|NCT01194973|Secondary|Percentage of Patients With Complete Hematologic Response|Proportion of Patients with Complete Hematologic response through end of study was determined and defined by normalization of platelet count and LDH sustained for at least two consecutive measurements obtained at least four weeks apart.|Through 26 weeks|The tabulations of the proportions of patients with Complete Hematologic Response through 26 weeks were performed for the ITT population. The number of patients with response and responder rate, along with an exact two-sided 95% CI were summarized.||Percentage of Participants||95% Confidence Interval|Number
825956|NCT01194973|Primary|Percentage of Patients With Modified Complete TMA Response|Proportion of Patients with Modified Complete TMA response through 26 weeks of treatment was determined and defined by normalization of hematological parameters (platelet count and LDH) and improvement in renal function (defined as ≥ 25% reduction from the baseline value in serum creatinine, which were sustained for at least two consecutive measurements obtained at least four weeks apart.|Through 26 weeks|The tabulations of the proportions of patients with Modified Complete TMA Response through 26 weeks were performed for the ITT population. Exact binomial two-sided 95% CI using the Clopper-Pearson method for the responder rate was presented.||Percentage of Participants||95% Confidence Interval|Number
825957|NCT01194973|Primary|Percentage of Patients With Complete TMA Response|Proportion of Patients with Complete TMA response was determined and defined by normalization of hematological parameters (platelet count and LDH) and preservation of renal function (defined as < 25% increase in serum creatinine from baseline) which were sustained for at least two consecutive measurements obtained at least four weeks apart.|Through 26 weeks|The tabulations of the proportions of patients with Complete TMA Response through 26 weeks were performed for the ITT population. Exact binomial two-sided 95% CI using the Clopper-Pearson method for the responder rate was presented.||Percentage of Participants||95% Confidence Interval|Number
825958|NCT01194999|Primary|Change in OAB Symptoms Post Pubovaginal Sling Operation|Measured through the administration of five overactive bladder questionnaires. Difference from baseline to follow-up evaluated using the Wilcoxon Signed Rank Test.|Baseline to final follow-up.|All patients enrolled in the study were analyzed, except for those currently being treated with antimuscarinic therapy.||participants|||Number
825959|NCT01195025|Primary|Elimination Half Life for Different Fluids Alone or When Combined|Volume kinetic analyses of the dilution of hemoglobin for different infusion fluids alone or in combination.|420 minutes|All the 10 participating subjects. Analysis studying the summary of each of the included infusion occasions. Only acetated Ringers, only colloid and finally a combination of colloid and acetated Ringers. Each experiment generated one elimination half-life (In experiment C one for acetated Ringer's and one for starch (HES 6%)).||Minutes|Participants|Inter-Quartile Range|Median
825988|NCT01195090|Secondary|Changes in High Sensitive C-reactive Protein|fasting high sensitive serum C-reactive protein change from baseline to 24 weeks|24 weeks|An intent-to-treat analysis with last observation carried forward was used to assess efficacy||mg/dl||Standard Error|Least Squares Mean
825961|NCT01195025|Secondary|Accuracy of Noninvasive Haemoglobin Measurement by Pulse Oximetry, for Different Fluids (Start to End of Infusion)|"Difference between true hemoglobin B-Hb and measured hemoglobin with pulseoximeter (SpHb)at the end of an infusion in relation to the initial measured values SpHb and B-Hb at the start of the infusion.
Relative difference (%) = (SpHb - Hb)/((Hb+SpHb)/2) x 100"|30 min|Only the pure experiments were included in this analysis. The combined experiment is not included since infusions were performed in sequence, which made the comparison of the bias for the two different fluids irrelevant.||percentage of relative difference|Participants|Inter-Quartile Range|Median
825962|NCT01195025|Secondary|Accuracy of Non-invasive Hemoglobin Monitoring for Different Fluids|"Pulse-oximeter based measurements compared with invasive hemoglobin measurements. All paired in the study.
Accuracy depending on which infusion is selected (Ringer's, Hydroxyethyl starch or a combination of both)."|420 min|The study was analysed per protocol and missing values were not replaced. All pairs of all collected data in one series of experiments. The number of analysed data points for each subject was in experiment A: 26, in experiment B: 32 and in experiment C: 42.||percentage of relative difference|Participants|Inter-Quartile Range|Median
825963|NCT01195025|Primary|Volume Effects for Hydroxyethyl Starch, Ringer's Solution or a Combination of Both.|"volume kinetics: mathematical calculation from hemoglobin variations during and after an infusion.
Degree of plasma dilution depending on which solution(s) and how much solution is/are given."|420 minutes|"All the 10 participating subjects. Analysis studying the summary of each of the included infusion occasions. Only acetated Ringers, only colloid and finally a combination of colloid and acetated Ringers.
Each experiment generated one distribution volume. (In experiment C one for acetated Ringer's and one for Starch (HES 6%))."||Litre||Inter-Quartile Range|Median
825964|NCT01195090|Secondary|Baseline High-density Lipoprotein Cholesterol (HDL-C)|Baseline HDL-C|Baseline|Baseline HDL-C||mg/dl||Standard Deviation|Mean
825965|NCT01195090|Secondary|Baseline Low-density Lipoprotein Cholesterol (LDL-C)|Baseline LDL-C|Baseline|Baseline LDL-C||mg/dl||Standard Deviation|Mean
825966|NCT01195090|Secondary|Baseline Triglyceride (TG)|Baseline TG|Baseline|Baseline TG||mg/dl||Standard Deviation|Mean
825967|NCT01195090|Secondary|Baseline Total Cholesterol|Baseline Total cholesterol|Baseline|Baseline Total cholesterol||mg/dl||Standard Deviation|Mean
825968|NCT01195090|Secondary|Baseline Body Weight|Baseline body weight|Baseline|Baseline body weight||kg||Standard Deviation|Mean
825969|NCT01195090|Secondary|Baseline Alanine-aminotransferase (ALT)|Baseline alanine-aminotransferase|Baseline|Baseline alanine-aminotransferase||IU/L||Standard Deviation|Mean
825970|NCT01195090|Secondary|Baseline Homoeostasis Model Assessment of Insulin Resistance (HOMA-IR)|Baseline HOMA-IR|Baseline HOMA-IR|Baseline HOMA-IR||HOMA-IR score||Standard Deviation|Mean
825971|NCT01195090|Secondary|Baseline High Sensitive C-reactive Protein|Baseline high sensitive C-reactive Protein|baseline|Baseline high sensitive C-reactive Protein||mg/dl||Standard Deviation|Mean
825972|NCT01195090|Secondary|Baseline Fasting Plasma Glucose|Baseline fasting plasma glucose|baseline|Baseline fasting plasma glucose||mg/dl||Standard Deviation|Mean
825973|NCT01195090|Secondary|Percentages of Patients With Severe Hypoglycemia|Proportion of severe hypoglycemia after treatment|24 weeks|Proportion of severe ypoglycemia after treatment||percentage|||Number
825974|NCT01195090|Primary|The Percentages of Patient Achieving an A1C <7%|The percentages of patient achieving an A1C <7% at endpoint|24 weeks|The percentages of patient achieving an A1C <7% at endpoint||percentage|||Number
825975|NCT01195090|Primary|Baseline A1C|baseline A1C|Baseline|baseline Laboratory measurements||percentage of Hb||Standard Deviation|Mean
825976|NCT01195090|Secondary|Percentages of Patients With Nasopharyngitis|Proportion of Nasopharyngitis after treatment|24 weeks|All patients who had taken at least one dose of study medication were included in the safety analysis||percentage|||Number
825977|NCT01195090|Secondary|Percentages of Patients With Gastrointestinal Adverse Events|Proportion of Gastrointestinal adverse events after treatment|24 weeks|All patients who had taken at least one dose of study medication were included in the safety analysis||percentge|||Number
825978|NCT01195090|Secondary|Percentages of Patients With Edema|proportion of edema after treatment|24 weeks|All patients who had taken at least one dose of study medication were included in the safety analysis||percentage|||Number
825979|NCT01195090|Secondary|Percentages of Patients With Mild to Moderate Hypoglycemia|Incidence of mild to moderate hypoglycemia after treatment|24 weeks|All patients who had taken at least one dose of study medication were included in the safety analysis||percentage|||Number
825980|NCT01195090|Secondary|Change in Fasting Plasma Alanine-aminotransferase (ALT)|ALT change from baseline to 24 weeks|24 weeks|An intent-to-treat analysis with last observation carried forward was used to assess efficacy||IU/L||Standard Error|Least Squares Mean
825981|NCT01195090|Secondary|Change in Fasting High-density Lipoprotein Cholesterol(HDL-C)|HDL-C change from baseline to 24 weeks|24 weeks|An intent-to-treat analysis with last observation carried forward was used to assess efficacy.||mg/dl||Standard Error|Least Squares Mean
825982|NCT01195090|Secondary|Change in Fasting Triglycerides(TG)|TG change from baseline to 24 weeks|24 weeks|An intent-to-treat analysis with last observation carried forward was used to assess efficacy.||mg/dl||Standard Error|Least Squares Mean
825983|NCT01195090|Secondary|Change in Fasting Low-density Lipoprotein Cholesterol (LDL-C)|LDL-C change from baseline to 24 weeks|24 weeks|An intent-to-treat analysis with last observation carried forward was used to assess efficacy||mg/dl||Standard Error|Least Squares Mean
825984|NCT01195090|Secondary|Change in Fasting Total-cholesterol|Total-cholesterol change from baseline to 24 weeks|24 weeks|An intent-to-treat analysis with last observation carried forward was used to assess efficacy.||mg/dl||Standard Error|Least Squares Mean
825985|NCT01195090|Secondary|Percentages of Patients With Total Adverse Events (AE)|percentages of total adverse events|24 weeks|All patients who had taken at least one dose of study medication were included in the safety analysis||percentage|||Number
825986|NCT01195090|Secondary|Body Weight Change|body weight change from baseline to 24 weeks|24 weeks|An intent-to-treat analysis with last observation carried forward was used to assess efficacy||kg||Standard Error|Least Squares Mean
825987|NCT01195090|Secondary|Changes in Homoeostasis Model Assessment of Insulin Resistance (HOMA-IR)|HOMA-IR change from baseline to 24 weeks|24 weeks|An intent-to-treat analysis with last observation carried forward was used to assess efficacy||HOMA-IR score||Standard Error|Least Squares Mean
825991|NCT01195103|Primary|Percentage of Participants Achieving Sedation Within 4 Minutes|"Percentage of patients achieving a Modified Observer's Assessment of Alertness/Sedation Scale score less than or equal to 4, and the block procedure initiated, within 4 minutes of the administration of the first bolus of study drug. The Modified Observer's Assessment of Alertness/Sedation Scale ranges from 0 (does not respond to deep stimulus) to 6 (agitated). The score of 4 equals lethargic response to name spoken in normal tone."|approximately 4 minutes after administration of first bolus of study drug|||percentage of participants|||Number
825992|NCT01195116|Primary|Change in Pain Score (1-10, 10 is Most Pain) From Baseline, to Average Post op Pain Score in PACU|It is a measurement instrument for subjective characteristics or attitudes towards pain that cannot be directly measured.|Assessed every 15 minutes while in Post Anesthesia Care Unit until discharged home, which was approximately 10 times on the average|||units on a scale||Standard Deviation|Mean
825993|NCT01195272|Secondary|Percentage of Participants With Acceptable and Not Acceptable Benefit-Risk Assessments|Benefit:Risk was defined at the participant level. It was considered acceptable if the DAS28 improvement represented at least a moderate European League Against Rheumatism (EULAR) response. The risks were based on the known adverse event (AE) profile of tocilizumab rather than on the actual AEs experienced by each participant|Weeks 12, 24, and 36|ITT Population; n=number of participants analyzed for the specified parameter at a given visit.||percentage of participants|||Number
825994|NCT01195272|Secondary|Disease Activity Score Based on 28-Joint Count (DAS28)|The DAS28 is a combined index for measuring disease activity in rheumatoid arthritis. The index includes swollen and tender joint counts, acute phase response (erythrocyte sedimentation rate [ESR] or C-reactive protein [CRP]), and general health status. The DAS28, which uses a 28 joint count, is derived from the original DAS, which includes a 44 swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.|Screening, Baseline, and Weeks 4, 8, 12, 16, 20, 24, 36, 48, and 52|ITT Population; n=number of participants analyzed for the specified parameter at a given visit.||score on a scale||Standard Deviation|Mean
825995|NCT01195272|Primary|Percentage of Neutrophils Positive for Dihydrorhodamine-123 (DHR) Oxidation|Phagocytosis can be measured by incubating neutrophils with PI-labeled heat killed S. aureus following incubation for 30 minutes. Neutrophils are co-incubated with DHR, which becomes oxidized by the products of the respiratory burst generated during phagocytosis. Fluorescence can then be measured by flow cytometry.|Visit 2, 3, 5, and 8 (Baseline and Weeks 4, 12 and 24)|ITT Population; n=number of participants analyzed for the specified parameter at a given visit.||percentage of positive neutrophils||Standard Deviation|Mean
825996|NCT01195272|Primary|Percentage of Neutrophils Positive for Propidium Iodide (PI)-Labeled Staphylococcus Aureus (S. Aureus) Uptake|S. aureus were heat killed then labeled with PI and opsonized with AB serum (SAPI). S. aureus was then incubated with the neutrophils for 30 minutes at 37 degrees Celsius. The neutrophils were washed, then the percentage of cells positive for the labeled S. aureus (that is, phagocytosed) was calculated via flow cytometry. A higher percentage represented more active phagocytosis.|Visit 2, 3, 5, and 8 (Baseline and Weeks 4, 12 and 24)|ITT Population; n=number of participants analyzed for the specified parameter at a given visit.||percentage of positive neutrophils||Standard Deviation|Mean
825997|NCT01195272|Primary|Mean Chemiluminescence (AUC) of Neutrophil Reactive Species Production Using Phorbol 12-Myristate 13-Acetate (PMA) Stimulation|Using luminol as a substrate for reactive oxidants, a chemical reaction is produced resulting in photon emission (chemiluminescence). PMA is a receptor-independent stimulator of the respiratory burst and the PMA response measures the total capacity of neutrophils to generate reactive oxidants. Measurements of reactive oxygen species are calculated as total chemiluminescence or the AUC.|Visit 2, 3, 5, and 8 (Baseline and predose at Weeks 4, 12 and 24)|ITT Population; n=number of participants analyzed for the specified parameter at a given visit.||chemiluminescence units * hours||Standard Deviation|Mean
825998|NCT01195272|Primary|Mean Chemiluminescence (Area Under the Concentration-time Curve [AUC]) of Neutrophil Reactive Species Production Using Formyl-Methionyl-Leucyl-Phenylalanine (fMLP) Stimulation|Using luminol as a substrate for reactive oxidants, a chemical reaction is produced resulting in photon emission (chemiluminescence). fMLP stimulation is mediated through the fMLP receptor on the cell surface. The fMLP response is only observed in primed neutrophils and response is a measure of in vivo priming. Measurements of reactive oxygen species are calculated as total chemiluminescence or the AUC.|Visit 2, 3, 5, and 8 (Baseline and predose at Weeks 4, 12 and 24)|ITT Population; n=number of participants analyzed for the specified parameter at a given visit.||chemiluminescence units*hours||Standard Deviation|Mean
825999|NCT01195272|Primary|Mean Fluorescence Intensity of Membrane Bound Tumor Necrosis Factor Alpha (mTNFα) on Neutrophil Surface|Neutrophils were incubated with labeled antibody against mTNF. Flow cytometry was used to determine the mean fluorescence intensity. Greater fluorescence correlates to a greater density of membrane bound TNF.|Visits 2, 3, and 5 (Baseline and Weeks 4 and 12)|ITT Population; n=number of participants analyzed for the specified parameter at a given visit.||fluorescence intensity unit||Standard Deviation|Mean
826000|NCT01195272|Primary|Mean Fluorescence Intensity of Interleukin-6 Receptor (Il-6R) on Neutrophil Surface|Neutrophils were incubated with labeled antibody against IL-6R. Flow cytometry was used to determine the mean fluorescence intensity. Greater fluorescence correlates with greater density of membrane bound IL-6 receptor.|Visits 2, 3, and 5 (Baseline and Weeks 4 and 12)|ITT Population; n=number of participants analyzed for the specified parameter at a given visit.||fluorescence intensity unit||Standard Deviation|Mean
826001|NCT01195272|Primary|Mean Fluorescence Intensity of CD63 on Neutrophil Surface|Neutrophils were incubated with labeled antibody against CD63b. Flow cytometry was used to determine the mean fluorescence intensity. Greater fluorescence correlates with greater azurophilic degranulation, an indicator of greater microbe killing.|Visits 2, 3, and 5 (Baseline and Weeks 4 and 12)|ITT Population; n=number of participants analyzed for the specified parameter at a given visit.||fluorescence intensity unit||Standard Deviation|Mean
826002|NCT01195272|Primary|Mean Fluorescence Intensity of CD62L (L Selectin) on Neutrophil Surface|Neutrophils were incubated with labeled antibody against CD62L (L selectin). Flow cytometry was used to determine the mean fluorescence intensity. Greater fluorescence correlates with greater adhesion of neutrophils to vessel walls.|Visits 2, 3 and 5 (Baseline and Weeks 4 and 12)|ITT Population; n=number of participants analyzed for the specified parameter at a given visit.||fluorescence intensity unit||Standard Deviation|Mean
826003|NCT01195272|Primary|Mean Fluorescence Intensity of CD18 on Neutrophil Surface|Neutrophils were incubated with labeled antibodies against CD18. Flow cytometry was used to determine the mean fluorescence intensity. Greater fluorescence correlates with greater adhesion, migration, and ingestion of complement-opsonized particles.|Visits 2, 3, and 5 (Baseline and Weeks 4 and 12)|ITT Population; n=number of participants analyzed at each visit||fluorescence intensity unit||Standard Deviation|Mean
826004|NCT01195272|Primary|Mean Fluorescence Intensity of CD11b on Neutrophil Surface|Neutrophils were incubated with labeled antibodies against CD11b. Flow cytometry was used to determine the mean fluorescence intensity. Greater fluorescence correlates with greater adhesion, migration, and ingestion of complement-opsonized particles.|Visits 2, 3, and 5 (Baseline and Weeks 4 and 12)|ITT Population; n=number of participants analyzed for the specified parameter at a given visit.||fluorescence intensity unit||Standard Deviation|Mean
826005|NCT01195272|Primary|Mean Percentage of Cells Staining Positive for Annexin V Binding With Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF)|Aging neutrophils translocate phosphatidylserine from the inner leaflet of the plasma membrane to the outer leaflet during the early stages of apoptosis. This translocation can be measured due to the affinity of FITC-labeled annexin V to bind exposed phosphatidylserine. Cells that stain positive to Annexin V binding are apoptotic. At 4 hrs and 20 hrs stimulated and control samples were analyzed for levels of apoptosis. GM-CSF is an agent that delays apoptosis. Percentage of cells that stained positive for Annexin V binding in the presence or absence of GM-CSF (GM-CSF delayed or constitutive) were determined by flow cytometry.|Visits 2, 3, 5, and 8 (Baseline and Weeks 4, 12 and 24)|ITT Population; n=number of participants analyzed for the specified parameter at a given visit.||percentage of cells staining positive||Standard Deviation|Mean
826006|NCT01195272|Primary|Mean Percentage of Cells Staining Positive for Annexin V Binding in Apoptosis|Aging neutrophils translocate phosphatidylserine from the inner leaflet of the plasma membrane to the outer leaflet during the early stages of apoptosis. This translocation can be measured due to the affinity of fluorescein isothiocyanate (FITC)-labeled annexin V to bind exposed phosphatidylserine. Cells that stain positive to Annexin V binding are apoptotic. At 4 hours (hrs) and 20 hrs stimulated and control samples were analyzed for levels of apoptosis.|Visits 2, 3, 5, and 8 (Baseline and Weeks 4, 12 and 24)|Intent-to-treat (ITT) Population: all participants in the Safety Population who provided follow-up data for neutrophils or at least 1 efficacy variable. n (number) equals (=) number of participants analyzed for the specified parameter at a given visit.||percentage of cells staining positive||Standard Deviation|Mean
826007|NCT01195363|Primary|Number of Patients Whose Mood Improved According to MADRS and YMRS Scale Scores.|The primary outcome measure was assessed by 50% reduction in: 1. depression scores on the Montgomery Asberg Depression Rating Scale (MADRS), which ranges from 0 indicating no symptoms to 60 indicating most symptoms 2. mania scores on the Young Mania Rating Scale (YMRS), which ranges from 0 indicating no symptoms to 60 indicating most symptoms.|Baseline visit to week 24|Per Protocol||participants|||Number
826008|NCT01195415|Secondary|Percentage of Treated Patients Experiencing Grade 3+ Toxicity Per National Cancer Institute Common Toxicity Criteria (CTC) Version 3.0||Up to 4 weeks|||percentage of patients|||Number
826009|NCT01195415|Secondary|Median Progression Free Survival|Median progression free survival was calculated for all treated patients. Assessed using the Kaplan-Meier method. The 95% confidence interval for this estimate will be computed using the Greenwood’s formula.|Up to 24 months|||months||95% Confidence Interval|Median
826010|NCT01195415|Secondary|The Number of Participants With an Objective Best Response (CR + PR)|The number of participants with either a complete response (CR) or a partial response (PR) will be calculated. A CR is defined as the disappearance of all target lesions. A PR is defined as at least a 30% decrease in the sum of the diameters of target lesions.|Up to 4 weeks|All treated patients were evaluable.||participants|||Number
826011|NCT01195415|Primary|Median Percent at Baseline and 3 Weeks in CD44+/ CD24+/ ESA+ Cells From Needle Biopsy Calculated Using FACS|The median percentage of CD44+CD24+ESA+ cells from needle biopsy were calculated at baseline and at 3 weeks using FACS. The difference between the two time points was calculated.|3 weeks|Of the 25 patients enrolled, only 22 were evaluable for the primary endpoint.||percentage of CD44+/ CD24+/ ESA+ cells||Full Range|Median
826012|NCT01195467|Secondary|Change From Baseline of CNS Toxicity as Measured by Hospital Anxiety and Depression (HADS) Score (Baseline vs Week 12)|To assess the change from baseline of CNS toxicity as measured by Hospital Anxiety and Depression (HADS) score (baseline vs week 12)|baseline to week 12||||||
826013|NCT01195467|Secondary|Change From Baseline in Adherence From Baseline After 12 Weeks of Raltegravir as Measured by the Adherence Questionnaire: Medication Adherence Self-Report Inventory (M-MASRI)|To assess the change from baseline in adherence from baseline after 12 weeks of raltegravir as measured by the adherence questionnaire: Medication Adherence Self-Report Inventory (M-MASRI)|baseline to week 12||||||
826014|NCT01195467|Secondary|Proportion of Patients With Grade 2-4 Non-CNS Adverse Events After 12 Weeks of Raltegravir Compared With Baseline|To assess the proportion of patients with grade 2-4 non-CNS adverse events after 12 weeks of raltegravir compared with baseline|baseline to week 12||||||
826015|NCT01195467|Secondary|Proportion of Patients With Grade 2-4 Laboratory Parameters (Excluding Lipids) After 12 Weeks of Raltegravir Compared With Baseline|To assess the proportion of patients with grade 2-4 laboratory parameters (excluding lipids) after 12 weeks of raltegravir compared with baseline|baseline to week 12||||||
826016|NCT01195467|Secondary|Change in Fasting Lipids (Total Cholesterol and Subfractions and Triglycerides) After 4 and 12 Weeks of Raltegravir|To assess the change in fasting lipids (total cholesterol and subfractions and triglycerides) after 4 and 12 weeks of raltegravir|week 4 to week 12||||||
826017|NCT01195467|Secondary|Proportion of Patients With Viral Load < 50 Copies/mL and <400 Copies/ml at Weeks 4 and 12 After Switching to Raltegravir|To assess the proportion of patients with viral load < 50 copies/mL and <400 copies/ml at weeks 4 and 12 after switching to raltegravir|week 4 to week 12||||||
826018|NCT01195467|Secondary|Change From Baseline to Week 12 in CD4+ Count After 12 Weeks of Raltegravir|Change from baseline to week 12 in CD4+ count after 12 weeks of raltegravir having switched from efavirenz-containing therapy|baseline to week 12||||||
826073|NCT01195779|Secondary|Number of Subjects Reporting Serious Adverse Events|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Day 0 to 179|||Subjects|||Number
826019|NCT01195467|Secondary|The Rate of Neuropsychiatric and Central Nervous System (CNS) Toxicity of Raltegravir Therapy After 12 Weeks on Treatment|"The rate of neuropsychiatric and central nervous system (CNS) toxicity as measured after 12 weeks of raltegravir therapy as measured by :
Sleep questionnaire
CNS toxicity (as determined by questionnaire based on efavirenz SPC and graded based on the ACTG adverse event scale)"|baseline to week 12|||percentage of improvement in sleep score|||Number
826020|NCT01195467|Primary|The Rate of Neuropsychiatric and Central Nervous System (CNS) Toxicity of Raltegravir Therapy After 4 Weeks on Treatment|To assess the rate of neuropsychiatric and central nervous system (CNS) toxicity as measured from baseline to 4 weeks of raltegravir therapy as measured by sleep questionnaire & CNS toxicity (as determined by questionnaire based on efavirenz SPC and graded based on the ACTG adverse event scale)|4 weeks|||percentage improvement in CNS score|||Number
826021|NCT01195584|Secondary|Days of Hospitalization|Total time of hospitalization.|at hospital discharge|analysis per protocol||Days||Standard Deviation|Mean
826022|NCT01195584|Secondary|Drainage|Drainage during hospitalization. The drainage was placed during the surgery and has been removed prior to hospital discharge. The amount of drainage in milliliters has been measured.|at hospital discharge|analysis per protocol||ml||Standard Deviation|Mean
826023|NCT01195584|Secondary|Number of Spine Segments|Number of affected spine segments. One spine segment is defined as 2 vertebral bodies and the intervertebral disc (between the 2 vertebral bodies). For this study the number fo affected spine segments is identical to the number of operated intervertebral discs.|peri operative|analysis per protocol||spine segments||Standard Deviation|Mean
826024|NCT01195584|Secondary|Blood Loss|Loss of blood during surgical procedure in milliliters.|after surgery|analysis per protocol||ml||Standard Deviation|Mean
826025|NCT01195584|Secondary|Operation Duration|Duration of the operation in minutes.|after surgery|analysis per protocol||Minutes||Standard Deviation|Mean
826026|NCT01195584|Primary|Postoperative Complications in the BMI Groups During Post Operative Hospitalization.|Postoperative complications related to the operation within the body mass index groups. A complication is any harmful event occuring during the surgery until hospital discharge.|at hospital discharge|Analysis per protocol||Events during hospitalization|||Number
826027|NCT01195597|Secondary|Sustained 80% Reduction in the Number of Cig/Day at Week- 24 From Baseline (Heavy Reducers)|Participants were monitored for up to 24 weeks. This is the number of partecipants who sustained 80% reduction at week 24|number of cigarettes/day as assessed at week 24|Intention to treat (ITT)||number of participants|||Number
826028|NCT01195597|Primary|Sustained 50% Reduction in the Number of Cig/Day at Week-24 From Baseline (Reducers)|Participants were monitored for up to 24 weeks. This is the number of smokers who sustained 50% reduction in the number of cig/day at week-24 from baseline (reducers).|number of cigarettes/day as assessed at week 24|Intention to treat (ITT)||number of participants|||Number
826029|NCT01195623|Secondary|Recurrence Rate|number of recurrences in treatment arms but also nature of recurrences|7 years|The number of legs with recurrence of varicose veins in the saphenofemoral junction (SFJ)or saphenopopliteal junction (SPJ)||legs|Participants||Number
826030|NCT01195623|Primary|Rate of Re-do Surgery|number of reoperations (legs) in the two treatment arms|7 years mean|The number of legs has been analyzed, randomized 166 legs in the duplex group and 177 in the no-duplex group||legs|||Number
826031|NCT01195636|Secondary|Change in Daily Sleep Interference Scale (DSIS) From Baseline to Week 3 of XPF-002 Treatment Compared to Week 3 of Placebo Treatment (With LOCF)|"Subjects recorded their sleep interference scores each morning for the previous night's sleep (using an 11-point Likert numerical rating scale (NRS); 0-10, where 0 = no interference with sleep and 10 = pain completely interfered with sleep). A daily sleep interference score was calculated.
This measurement is the 'Change in DSIS score from baseline between the 3rd week of XPF-002 treatment and the 3rd week of placebo treatment for each subject'. Any missing scores were imputed using last observation carried forward (LOCF).
The reduction in DSIS on each treatment compared to baseline is reported as a negative number. A larger negative number, indicates a greater reduction in sleep interference due to pain. (A positive number would indicate sleep interference due to pain was increased compared to baseline.)"|3 Weeks|"The Efficacy Evaluable Population was used for this analysis. This population includes randomised subjects who recorded both baseline and post-baseline data in both treatment periods. The maximum number of subjects who could contribute to this population is 57.
Last Observation Carried Forward (LOCF) was used to impute any missing data."||units on a scale||95% Confidence Interval|Least Squares Mean
826032|NCT01195636|Secondary|Change in Overall Neuropathic Pain Symptom Inventory (NPSI) From Baseline to Week 3 (With LOCF)|"Subjects completed the NPSI questionaire at various timepoints during the study. An overall NPSI score (the sum of 10 quantitative responses, each scored 0-10, max score = 100) was calculated each time the NPSI questionaire was completed.
This measurement is the 'Change in Neuropathic Pain Symptom Inventory (NPSI) score from baseline between the 3rd week of XPF-002 treatment and the 3rd week of placebo treatment for each subject. If the NPSI score for Week 3 was missing, the last value from within the same treatment period was used (ie last observation carried forward (LOCF)).
The reduction in NPSI on each treatment compared to baseline is reported as a negative number. A larger negative number, indicates a greater reduction in neuropathic pain symptoms. (A positive number would indicate neuropathic pain symptoms were increased compared to baseline.)"|3 Weeks|"The Efficacy Evaluable Population was used for this analysis. This population includes randomised subjects who recorded both baseline and post-baseline data in both treatment periods. The maximum number of subjects who could contribute to this population is 57.
Last Observation Carried Forward (LOCF) was used to impute any missing data."||units on a scale||Standard Deviation|Mean
826033|NCT01195636|Secondary|Proportion of Subjects Using Rescue Analgesic Medications During XPF-002 Treatment Compared to Placebo Treatment||3 Weeks|||participants|||Number
826034|NCT01195636|Secondary|Proportion of Subjects Achieving 30% Improvement in Mean Daily Pain Score From Baseline to Week 3 on XPF-002 Treatment Compared to Placebo Treatment||3 Weeks|"The Efficacy Evaluable Population was used for this analysis. This population includes randomised subjects who recorded both baseline and post-baseline data in both treatment periods.
Missing data were not imputed. Only subjects who recorded sufficient pain scores in each treatment period were included in this analysis."||participants|||Number
826168|NCT01196104|Secondary|Week 20 (Follow-up) Change From Baseline in Forced Expiratory Volume in 1 Second|Week 20 (Follow-up, 4 weeks after discontinuation of study treatment) Change from Baseline in FEV1|Baseline to Week 20|Safety Population, with data available at Week 20||L||Standard Deviation|Mean
826035|NCT01195636|Secondary|Proportion of Subjects Achieving 50% Improvement in Mean Daily Pain Score From Baseline to Week 3 on XPF-002 Treatment Compared to Placebo Treatment||3 weeks|"The Efficacy Evaluable Population was used for this analysis. This population includes randomised subjects who recorded both baseline and post-baseline data in both treatment periods.
Missing data were not imputed. Only subjects who recorded sufficient pain scores in each treatment period were included in this analysis."||participants|||Number
826036|NCT01195636|Secondary|Proportion of Subjects Achieving at Least a 1 Point Improvement in Mean Daily Pain Score (Measured Using the 11-point Likert NRS) From Baseline to Week 3 on XPF-002 Compared to Placebo|Subjects recorded their pain scores 4 times each day (using an 11-point Likert numerical rating scale (NRS); 0-10, where 0 = no pain and 10 = worst pain imaginable). An average (mean) daily pain score was calculated.|3 Weeks|"The Efficacy Evaluable Population was used for this analysis. This population includes randomised subjects who recorded both baseline and post-baseline data in both treatment periods.
Missing data were not imputed. Only subjects who recorded sufficient pain scores in each treatment period were included in this analysis."||participants|||Number
826037|NCT01195636|Secondary|Change in Mean Daily Pain Score From Baseline to Week 3|"Subjects recorded their pain scores 4 times each day (using an 11-point Likert numerical rating scale (NRS); 0-10, where 0 = no pain and 10 = worst pain imaginable). An average (mean) daily pain score was calculated.
This measurement is the 'Change in mean daily pain score from baseline between the 3rd week of XPF-002 treatment and the 3rd week of placebo treatment for each subject'. Missing data were not imputed.
The reduction in pain on each treatment compared to baseline is reported as a negative number. A larger negative number, indicates a greater reduction in pain. (A positive number would indicate pain was increased compared to baseline.)"|3 Weeks|"The Efficacy Evaluable Population was used for this analysis. This population includes randomised subjects who recorded both baseline and post-baseline data in both treatment periods.
Missing data were not imputed. Only subjects who recorded sufficient pain scores in each treatment period were included in this analysis."||units on a scale||95% Confidence Interval|Least Squares Mean
826038|NCT01195636|Secondary|Change in Mean Daily Pain Score From Baseline to Week 2|"Subjects recorded their pain scores 4 times each day (using an 11-point Likert numerical rating scale (NRS); 0-10, where 0 = no pain and 10 = worst pain imaginable). An average (mean) daily pain score was calculated.
This measurement is the 'Change in mean daily pain score from baseline between the 2nd week of XPF-002 treatment and the 2nd week of placebo treatment for each subject'. Missing data were not imputed.
The reduction in pain on each treatment compared to baseline is reported as a negative number. A larger negative number, indicates a greater reduction in pain. (A positive number would indicate pain was increased compared to baseline.)"|2 week|"The Efficacy Evaluable Population was used for this analysis. This population includes randomised subjects who recorded both baseline and post-baseline data in both treatment periods.
Missing data were not imputed. Only subjects who recorded sufficient pain scores in each treatment period were included in this analysis."||units on a scale||95% Confidence Interval|Least Squares Mean
826039|NCT01195636|Secondary|Change in Mean Daily Pain Score From Baseline to Week 1|"Subjects recorded their pain scores 4 times each day (using an 11-point Likert numerical rating scale (NRS); 0-10, where 0 = no pain and 10 = worst pain imaginable). An average (mean) daily pain score was calculated.
This measurement is the 'Change in mean daily pain score from baseline between the 1st week of XPF-002 treatment and the 1st week of placebo treatment for each subject'. Missing data were not imputed.
The reduction in pain on each treatment compared to baseline is reported as a negative number. A larger negative number, indicates a greater reduction in pain. (A positive number would indicate pain was increased compared to baseline.)"|1 week|"The Efficacy Evaluable Population was used for this analysis. This population includes randomised subjects who recorded both baseline and post-baseline data in both treatment periods.
Missing data were not imputed. Only subjects who recorded sufficient pain scores in each treatment period were included in this analysis."||units on a scale||95% Confidence Interval|Least Squares Mean
826040|NCT01195636|Primary|Change in Mean Daily Pain Score From Baseline to Week 3 (With LOCF)|"Subjects recorded their pain scores 4 times each day (using an 11-point Likert numerical rating scale (NRS); 0-10, where 0 = no pain and 10 = worst pain imaginable). An average (mean) daily pain score was calculated.
This measurement is the 'Change in mean daily pain score from baseline between the 3rd week of XPF-002 treatment and the 3rd week of placebo treatment for each subject'. Any missing mean daily pain scores were imputed using last observation carried forward (LOCF).
The reduction in pain on each treatment compared to baseline is reported as a negative number. A larger negative number, indicates a greater reduction in pain. (A positive number would indicate pain was increased compared to baseline.)"|3 weeks|"The Efficacy Evaluable Population was used for this analysis. This population includes randomised subjects who recorded both baseline and post-baseline data in both treatment periods. The maximum number of subjects who could contribute to this population is 57.
Last Observation Carried Forward (LOCF) was used to impute any missing data."||units on a scale||95% Confidence Interval|Least Squares Mean
826041|NCT01195662|Secondary|Proportion of Participants With Orthostatic Hypotension at Baseline and Week 12, Including Data After Rescue|Orthostatic hypotension was defined as a decrease from supine to standing of > 20 mmHg in systolic BP or >10 mmHg in diastolic BP. Proportion was calculated from number of participants with orthostatic hypotension (n) divided by the number of treated participants (N). n/N presented as a percent (%). Baseline was Day 1 of the double blind Period. Measurements for orthostatic hypotension were taken on Day 1 and at Week 12 visit and does not reflect AEs reported by the investigator.|Baseline (Day 1), Week 12|N= All randomized participants who received double-blind medication and had non-missing Week (t) values. Week 12 includes participants with orthostatic hypotension during Week 12 visit window. Data after rescue included.||Percent of Participants|||Number
826042|NCT01195662|Secondary|Number of Participants With Normal or Abnormal Electrocardiogram Summary Tracing at Week 12 (LOCF), Including Data After Rescue|12-Lead electrocardiograms (ECGs) were performed at Enrollment, Day 1 of Double Blind Period and Week 12/End of treatment visit (last observation carried forward) on participants who were supine. ECGs were assessed by the investigator as normal or abnormal. Baseline (BL) was Day 1 prior to dosing or last observation prior to dosing.|Baseline, Week 12|N= All randomized participants who received double-blind medication. Data after rescue included.||participants|||Number
826169|NCT01196104|Secondary|Week 20 (Follow-up) Forced Expiratory Volume in 1 Second|Week 20 (Follow-up) FEV1, 4 weeks after discontinuation of study treatment|Week 20 (Follow-up)|Safety Population, with data available at Week 20||L||Standard Deviation|Mean
826043|NCT01195662|Secondary|Number of Participants With Elevated Liver Laboratory Tests in Participants Treated With Double Blind 10 mg Dapagliflozin or Placebo , Including Data After Rescue|Laboratories were obtained at Day 1, Weeks 4, 8 and 12 in the Double Blind Period. Baseline: last assessment prior to start of first dose of double-blind treatment. Includes laboratory values measured after the first date of double-blind treatment and up to and including the last day of double blind treatment plus 30 days. Upper limit of normal (ULN);, alanine aminotransferase (ALT); aspartate aminotransferase (AST); alkaline phosphatase (ALP). Marked abnormality (High): AST and ALT (>3*ULN); ALP (>1.5*ULN); bilirubin (>1.5*ULN). Participants with abnormally elevated liver laboratory tests were followed 30 days after the last dose of study drug.|Baseline (Day 1) to last dose double blind medication (Week 12) Plus 30 days|N=All randomized participants who received at least 1 dose of study medication. n=number of participants treated with double blind study medication with at least one non-missing post-baseline value. Data after rescue included.||participants|||Number
826044|NCT01195662|Secondary|Number of Participants With Marked Chemistry Laboratory Abnormalities in 12 Week Double Blind Treatment Period, Including Data After Rescue|Samples obtained: Day 1, Weeks 4, 8,12 in Double Blind Period. Baseline: last assessment prior to start of first dose of double-blind treatment. Pretreatment (PreRX); grams per deciliter (g/dL); upper limit of normal (ULN); milliequivalent per liter (mEq/L); greater than (>) less than (<); Units per liter (U/L), Marked abnormality Low (High): hemoglobin <6 (>18 females or >20 males) g/dL; creatinine (>=1.5*preRX, >=2.5 mg/dL); glucose < 54 or (> 350) mg/dL; albumin <= 2 or (> 6) g/dL; creatine kinase >5*ULN; albumin/creatinine ratio (>1800 mg/G); calcium <7.5 (>1 and >0.5 from PreRX) mg/dL; bicarbonate <=13 meq/dL; potassium <=2.5 (>6) meq/L; magnesium <1 (>4) mEq/L; sodium < 130 mEq/L (>150 mEq/L; phosphorus (>=5.6 mg/dL age 17-65, >=5.1 is >=66 years); Albumin/creatinine ratio (>1800 mg/g). Note: Hepatic tests are presented separately in next outcome measure.|Baseline (Day 1) to last dose double blind medication (Week 12) plus 4 days|N=All randomized participants who received at least one dose of double-blind medication. n=all treated participants who had non-missing Baseline and on-study measurement. Data after rescue included.||participants|||Number
826045|NCT01195662|Secondary|Number of Participants With Deaths,Serious Adverse Events (SAEs), Adverse Events (AEs), Hypoglycemia Events, Discontinuation Due to AEs, SAEs and Hypoglycemia, During the 12 Week Double Blind Period, Including Data After Rescue|Medical Dictionary for Regulatory Activities (MedDRA), version 15.1 AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or missing relationship to study drug as per the investigator. Events captured from baseline to last double blind dose plus 4 days for AEs, plus 30 days for SAEs during the Double Blind 12 Week Period. Only hypoglycemia reported as an SAE is included in AE/SAE categories . All reported hypoglycemia events within 4 days of last day of treatment are included as hypoglycemic events.|Baseline to last dose of 12 weeks of double blind medication plus 30 days if SAE or plus 4 days if AE/hypoglycemic event|Randomized participants who received double-blind study medication in the double-blind period.||participants|||Number
826046|NCT01195662|Secondary|Adjusted Mean Change From Baseline in Serum Uric Acid at Week 12 in Double-Blind Treatment Period - Randomized Participants|Adjusted mean change in serum uric acid from baseline at Week 12 was calculated. Serum uric acid was measured in milligrams per deciliter (mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. Serum uric acid measurements were obtained at qualification and lead-in (Day -28) periods, and at Day 1, Weeks 4, 8, and 12, in the double-blind period but only the change from baseline at Week 12 was considered a secondary endpoint and is presented.|Baseline, Week 12|All randomized participants who received double-blind medication and had non-missing Baseline and on-study measurement. Data after rescue was included.||mg/dL||Standard Error|Mean
826047|NCT01195662|Secondary|Adjusted Mean Change From Baseline in 24-hr Ambulatory Diastolic Blood Pressure at Week 12 (LOCF)|Ambulatory 24 hour (hr) BP monitoring (ABPM) was performed at baseline, which was during the lead-in period (between Day -7 and Day -1 prior to randomization) and 1 week prior to the Week 12 visit/end of treatment visit. If no Week 12 measurement was available, the last available earlier post-baseline measurement was used (LOCF). Initiation of the 24-hr ABPM began between 6am and 11am to ensure trough BP measurements were obtained. The ABPM units were calibrated, and used per the manufacturer’s and central ABPM vendor instructions. BP was measured in mmHg. Participants had to have a mean 24-hour ABPM ≥ 130/80 mmHg prior to randomization. All medication was withheld on the morning of the study visit and brought to the visit site by the participant. Once the ABPM cuff was in place, all morning medication was taken while at the site.|Baseline, Week 12|All randomized participants who received double-blind medication and had non-missing Baseline and on-study measurement (Week 12 LOCF). Data after rescue excluded from analyses.||mmHg||Standard Error|Mean
826048|NCT01195662|Secondary|Adjusted Mean Change From Baseline in Seated Diastolic Blood Pressure (DBP) for 12 Week Double-Blind Treatment Period - Randomized Participants|Diastolic BP was measured in millimeters of mercury (mmHg) on Day -1, Day 1, Weeks 2, 4, 8, and 12 of the Double Blind Period. Diastolic BP values were obtained after the participant was seated for quietly for 10 minutes; a mean of 3 replicate measurements was taken at least 1 minute apart. However, if the 3 consecutive seated BP readings were not within 8 mm Hg of each other, an additional 2 BP readings were obtained (total = 5) and incorporated into the calculated mean. BP was measured in both arms. If the pressure was higher in one arm than the other, then this arm was used; if no difference, the participant’s dominant arm was used for all future BP measurements. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. Participants refrained from ingestion of caffeine, alcohol, or nicotine at least 10 hours prior to their visit and having their BP measured.|Baseline to Week 12|All randomized participants who received double-blind medication and had non-missing Baseline and on-study measurement. Data after rescue excluded from analyses||mmHg||Standard Error|Mean
826067|NCT01195701|Secondary|FSFI Desire|The desire domain of the Female Sexual Function Index (FSFI) consists of two questions and measures the frequency (almost never to almost always) and level (very low to very high) of sexual desire. Item scores range from 1 to 5, with higher scores indicating better sexual function, and the domain score is weighted by a factor of 0.6, such that the domain score can range from 1.2 to 6.0.|baseline visit|||units on a scale||Standard Deviation|Mean
826049|NCT01195662|Secondary|Adjusted Mean Change From Baseline in 24-hour Ambulatory Systolic Blood Pressure at Week 12 Last Observation Carried Forward (LOCF)|Ambulatory 24 hour (hr) blood pressure monitoring (ABPM) was performed at baseline, which was during the lead-in period (between Day -7 and Day -1 prior to randomization) and 1 week prior to the Week 12 visit/end of treatment visit. If no Week 12 measurement was available, the last available earlier post-baseline measurement was used (LOCF) for analysis. Initiation of the 24-hr ABPM began between 6am and 11am to ensure trough BP measurements were obtained.The ABPM units were calibrated, and used per the manufacturer’s and central ABPM vendor instructions. BP was measured in mmHg. Participants had to have a mean 24-hour ABPM ≥ 130/80 mmHg prior to randomization. All medication was withheld on the morning of the study visit and brought to the visit site by the participant. Once the ABPM cuff was in place, all morning medication was taken while at the site.|Baseline, Week 12|All randomized participants who received double-blind medication and had non-missing Baseline and Week 12 (LOCF) values. Data after rescue excluded from analyses.||mmHg||Standard Error|Mean
826050|NCT01195662|Primary|Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) for 12 Week Double-Blind Treatment Period - Randomized Participants|Adjusted mean change in glycosylated hemoglobin ( HbA1c) from baseline at Week 12 was calculated. HbA1c was measured as percent of hemoglobin by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. HbA1c values were obtained at enrollment and lead-in (Day -28) periods, and at Day 1, Weeks 4, 8, and 12, in the double-blind period.|Baseline to Week 12|All randomized participants who received double-blind medication and had non-missing Baseline and on-study measurement. Data after rescue included.||Percent of Hemoglobin||Standard Error|Mean
826051|NCT01195662|Primary|Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure for 12 Week Double-Blind Treatment Period - Randomized Participants|Systolic blood pressure (SBP) was measured in millimeters of mercury (mmHg) on Day -1, Day 1, Weeks 2, 4, 8, and 12 of the Double Blind Period. Blood pressure (BP) values were obtained after the participant was seated for quietly for 10 minutes; a mean of 3 replicate measurements was taken at least 1 minute apart. However, if the 3 consecutive seated BP readings were not within 8 mm Hg of each other, an additional 2 BP readings were obtained (total = 5) and incorporated into the calculated mean. BP was measured in both arms. If the BP was higher in one arm than the other, then this arm was used; if no difference, the participant’s dominant arm was used for all future BP measurements. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. Participants refrained from ingestion of caffeine, alcohol, or nicotine at least 10 hours prior to their visit and having their BP measured.|Baseline to Week 12|All randomized participants who received double-blind medication and had non-missing Baseline and on-study measurement. Data after rescue excluded from analyses||mmHg||Standard Error|Mean
826052|NCT01195675|Other Pre-specified|Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Blood Chemistry and Assessment of Tolerability by the Investigator|Clinically relevant abnormalities for physical examination, vital signs, ECG, blood chemistry, haematology, urinanalysis and assessment of tolerability by the investigator. New abnormal findings or worsening of baseline conditions were reported as adverse events (AEs). Time frame for AE reporting includes the period of first drug administration until end of study. A more detailed definition of the used time frame and MedDRA Version can be found in the AE section.|Drug administration until beginning of next sequence/end of trial, up to 48 days|Treated set (TS): All subjects who were dispensed trial medication and were documented to have taken at least one dose of investigational treatment.||participants|||Number
826053|NCT01195675|Other Pre-specified|Placebo Corrected Change From Mean Baseline at Any Time Point Between 30 Minutes and 24 Hours After Dosings.|"The placebo corrected change from mean baseline is defined per time point as the difference of the change from baseline for empa or moxifloxacin minus the average change from baseline obtained for the two administrations of placebo. The clinically relevant information (and endpoint resulting from ICH E14) is shown by the maximum mean value of all measurements.
Results are presented for the greatest change, for empa 25mg the greatest change was seen at the 24 hour time point, for empa 200 mg and moxifloxacin the greatest change was seen at the 2.5 hour time point."|60 minutes (min), 50min and 40 min before the first dose and 30min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h and 24h after the first dose|Full analysis set (FAS): all treated subjects who had at least one baseline assessment and at least one post-baseline assessment for at least one ECG endpoint.||ms||Standard Deviation|Mean
826054|NCT01195675|Other Pre-specified|Time-matched Change From Placebo in QTcN Between 30 Minutes and 24 Hours After Dosing.|"The time-matched change from placebo is defined per time point as the difference of the ECG measurement following administration of empa or moxifloxacin minus the average of the measurements obtained following the two administrations of placebo. The clinically relevant information (and endpoint resulting from ICH E14) is shown by the maximum mean value of all measurements.
Results are presented for the greatest change, for empa 25mg the greatest change was seen at the 24 hour time point, for empa 200 mg and moxifloxacin the greatest change was seen at the 2.5 hour time point."|60 minutes (min), 50min and 40 min before the first dose and 30min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h and 24h after the first dose|Full analysis set (FAS): all treated subjects who had at least one baseline assessment and at least one post-baseline assessment for at least one ECG endpoint.||ms||Standard Deviation|Mean
826055|NCT01195675|Primary|Empa 200mg: Mean QTcN Change From Baseline Between 1 and 4 Hours After Dosing|"Mean QTcN (heart rate-corrected QT interval, using a study population-based approach) from the ECGs obtained between 1h to 4h following drug administration minus the mean QTcN from the baseline ECGs obtained pre-dose at each visit, for empa 200mg.
Note, the treatment means presented are actually adjusted means."|60 minutes (min), 50min and 40 min before the first dose and 1 hour (h), 1.5h, 2h, 2.5h, 3h and 4h after the first dose|Full analysis set (FAS): all treated subjects who had at least one baseline assessment and at least one post-baseline assessment for at least one ECG endpoint.||ms|Participants|Standard Deviation|Mean
826068|NCT01195701|Secondary|Female Sexual Function Index (FSFI) Total Score|The FSFI is a validated index of sexual function, consisting of a total score and six subscales or domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. The FSFI total is the sum of the six domain scores, each of which is weighted as noted. The FSFI total score can range from 2 to 36, with higher scores indicating better sexual function. A total score of 26.55 has been identified as the ideal cut point for differentiating between normal sexual function and sexual dysfunction.|baseline visit|||units on a scale||Standard Deviation|Mean
826056|NCT01195675|Secondary|Empa 200mg: Change From Mean Baseline in QTcN at Each Time Point Between 30 Minutes and 24 Hours After Dosings|"Change from mean baseline in QTcN at each time point between 30 minutes and 24 hours after dosings for empa 200mg. The clinically relevant information (and endpoint resulting from ICH E14) is shown by the maximum upper confidence limit value over time.
For this outcome results are presented for the 2.5 hour timepoint as this was when the maximum value was seen.
Note, the presented means are actually adjusted means."|60 minutes (min), 50min and 40 min before the first dose and 0.5 hour (h), 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h and 24h after the first dose|Full analysis set (FAS): all treated subjects who had at least one baseline assessment and at least one post-baseline assessment for at least one ECG endpoint.||ms|Participants|Standard Error|Mean
826057|NCT01195675|Secondary|Empa 25mg: Change From Mean Baseline in QTcN at Each Time Point Between 30 Minutes and 24 Hours After Dosings|"Change from mean baseline in QTcN at each time point between 30 minutes and 24 hours after dosings for empa 25mg. The clinically relevant information (and endpoint resulting from ICH E14) is shown by the maximum upper confidence limit value over time.
For this outcome results are presented for the 24 hour timepoint as this was when the maximum value was seen.
Note, the presented means are actually adjusted means."|60 minutes (min), 50min and 40 min before the first dose and 0.5 hour (h), 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h and 24h after the first dose|Full analysis set (FAS): all treated subjects who had at least one baseline assessment and at least one post-baseline assessment for at least one ECG endpoint.||ms|Participants|Standard Error|Mean
826058|NCT01195675|Secondary|Mean QTcN Change From Baseline Between 2 and 4 Hours After Dosing|"Mean changes from baseline in QTcN from all ECGs taken between 2 hours and 4 hours after dosings
Note, the means presented are actually adjusted means."|60 minutes (min), 50min and 40 min before the first dose and 2 hour (h), 2.5h, 3h and 4h after the first dose|Full analysis set (FAS): all treated subjects who had at least one baseline assessment and at least one post-baseline assessment for at least one ECG endpoint.||ms|Participants|Standard Error|Mean
826059|NCT01195675|Secondary|Empa 200 mg: Mean QTcN Change From Baseline Between 30 Minutes and 24 Hours After Dosing|"Mean changes from baseline in QTcN from all ECGs taken between 30 minutes and 24 hours after dosings, for empa 200 mg.
Note, presented means are actually adjusted means."|60 minutes (min), 50min and 40 min before the first dose and 30min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h and 24h after the first dose|Full analysis set (FAS): all treated subjects who had at least one baseline assessment and at least one post-baseline assessment for at least one ECG endpoint.||ms|Participants|Standard Deviation|Mean
826060|NCT01195675|Secondary|Empa 25 mg: Mean QTcN Change From Baseline Between 30 Minutes and 24 Hours After Dosing|"Mean changes from baseline in QTcN from all ECGs taken between 30 minutes and 24 hours after dosings, for empa 25 mg.
Note, presented means are actually adjusted means."|60 minutes (min), 50min and 40 min before the first dose and 30min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h and 24h after the first dose|Full analysis set (FAS): all treated subjects who had at least one baseline assessment and at least one post-baseline assessment for at least one ECG endpoint.||ms|Participants|Standard Error|Mean
826061|NCT01195675|Primary|Empa 25mg: Mean QTcN Change From Baseline Between 1 and 4 Hours After Dosing|"Mean QTcN (heart rate-corrected QT interval, using a study population-based approach) from the ECGs obtained between 1h to 4h following drug administration minus the mean QTcN from the baseline electrocardiogram (ECGs) obtained pre-dose at each visit, for empa 25mg.
Note, the treatment means presented are actually adjusted means."|60 minutes (min), 50min and 40 min before the first dose and 1 hour (h), 1.5h, 2h, 2.5h, 3h and 4h after the first dose|Full analysis set (FAS): all treated subjects who had at least one baseline assessment and at least one post-baseline assessment for at least one ECG endpoint.||ms|Participants|Standard Error|Mean
826062|NCT01195701|Secondary|FSFI Pain|The pain domain of the Female Sexual Function Index (FSFI) consists of three questions and measures the frequency of discomfort or pain during and following vaginal penetration (almost never to almost always), and the level of discomfort or pain (very low to very high). Item scores range from 0 to 5, with higher scores indicating better sexual function, and the pain score is weighted by a factor of 0.4, such that the domain score can range from 0 to 6.0.|baseline visit|||units on a scale||Standard Deviation|Mean
826063|NCT01195701|Secondary|FSFI Satisfaction|The satisfaction domain of the Female Sexual Function Index (FSFI) consists of three questions and measures satisfaction (very dissatisfied to very satisfied) with emotional closeness with partner, sexual relationship with partner, and overall sexual relationship with partner. Item scores range from 0 (or 1) to 5, with higher scores indicating better sexual function, and the satisfaction score is weighted by a factor of 0.4, such that the domain score can range from 0.8 to 6.0.|baseline visit|||units on a scale||Standard Deviation|Mean
826064|NCT01195701|Secondary|FSFI Orgasm|The orgasm domain of the Female Sexual Function Index (FSFI) consists of three questions and measures the frequency of orgasm (almost never to almost always), difficulty in achieving orgasm (extremely difficult to not difficult), and satisfaction with the ability to reach orgasm (very dissatisfied to very satisfied). Item scores range from 0 to 5, with higher scores indicating better sexual function, and the orgasm score is weighted by a factor of 0.4, such that the domain score can range from 0 to 6.0.|baseline visit|||units on a scale||Standard Deviation|Mean
826065|NCT01195701|Secondary|FSFI Lubrication|The lubrication domain of the Female Sexual Function Index (FSFI) consists of four questions and measures the frequency of lubrication (almost never to almost always), the difficulty in becoming lubricated (extremely difficult to not difficult), frequency of maintaining lubrication (almost never to almost always), and difficulty in maintaining lubrication (extremely difficult to not difficult). Item scores range from 0 to 5, with higher scores indicating better sexual function, and the lubrication score is weighted by a factor of 0.3, such that the domain score can range from 0 to 6.0.|baseline visit|||units on a scale||Standard Deviation|Mean
826066|NCT01195701|Secondary|FSFI Arousal|The arousal domain of the Female Sexual Function Index (FSFI) consists of four questions and measures the frequency (almost never to almost always) and level (very low to very high) of sexual arousal; and confidence in becoming aroused (very low to very high confidence) and frequency of satisfaction with arousal (almost never to almost always). Item scores range from 0 to 5, with higher scores indicating better sexual function, and the arousal score is weighted by a factor of 0.3, such that the domain score can range from 0 to 6.0.|baseline visit|||units on a scale||Standard Deviation|Mean
826069|NCT01195701|Secondary|Free Androgen Index|Free androgen index is calculated as the ratio of total testosterone to sex hormone binding globulin (SHBG)|Between day 1-14 (follicular phase) of menstrual cycle|||ratio||95% Confidence Interval|Number
826074|NCT01195779|Secondary|Number of Subjects Reporting Potential Immune-mediated Diseases|Potential Immune-Mediated Diseases (pIMDs) are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.|From Day 0 to 179|This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.|||||
826075|NCT01195779|Secondary|Number of Subjects Reporting Adverse Events With Medically Attended Visits|A mediaclly attended visit is defined as hospitalisation, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason.|From Day 0 to 179|This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.|||||
826076|NCT01195779|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|within 28 days (Day 0 to Day 27) after any vaccination|||Subjects|||Number
826077|NCT01195779|Secondary|Number of Subjects Reporting Solicited Local and General Symptoms|Solicited local symptoms included pain, redness and swelling at the injection site. Solicited general symptoms included drowsiness, fever, irritability and loss of appetite.|during a 7 day follow-up period (Day 0 to 6) after any vaccination|This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.|||||
826078|NCT01195779|Secondary|Serum Neutralising Antibody Titers|Titers were planned to be expressed as Geometric Mean Titers (GMTs). Analysis was planned to be done for antibodies against all 4 vaccine strains.|on Days 0, 28/56 and 180|This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.|||||
826079|NCT01195779|Secondary|Serum HI Antibody Titers|Titers were planned to be expressed as Geometric Mean Titers (GMTs). Analysis was planned to be done for antibodies against all 4 vaccine strains.|on Days 0, 28/56 and 180|This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.|||||
826080|NCT01195779|Primary|Number of Subjects Reporting Fever of at Least Grade 2 or Higher|Grade 2 fever was defined as axillary temperature above 38 degrees Celcius.|Within 7 days (Day 0 to 6) follow-up period after any dose of study vaccine|This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.|||||
826081|NCT01195779|Primary|Geometric Mean Number of All-CD4 Cytokine Positive Cells|Geometric mean of the number of CD4 cytokine positive T cells per million T cells.|at Day 28/ Day 56|This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.|||||
826082|NCT01195779|Primary|Serum Neutralizing Antibody Titers||at Day 28/ Day 56|This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.|||||
826083|NCT01195779|Primary|Serum Haemagglutination-inhibition (HI) Antibody Titers|Titers were planned to be expressed as Geometric Mean Titers (GMTs). Analysis was planned to be done for antibodies against all 4 vaccine strains.|at Day 28/ Day 56|This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.|||||
826084|NCT01195831|Secondary|Evaluation of the Quality of Life||Baseline to weeks 2 and 4||||||
826085|NCT01195831|Secondary|Patients With Success (Patient's Itching Score=None) at Week 4||4 weeks||||||
826086|NCT01195831|Secondary|For Each Clinical Sign (Redness, Thickness, Scaliness), the Percentage of Patients With Success (Clinical Score=0) at Week 4||4 weeks||||||
826087|NCT01195831|Secondary|Patients With Success (Total Sign Score ≤1) at Week 4|"Investigators assessed scalp psoriasis lesions in terms of three clinical signs: redness, thickness and scaliness. For each clinical sign a single score, reflecting the average severity of all lesions on the scalp, was derived according to a 5-point scale ranging from 0 to 4 (0= best;4= worst). The sum of the three individual scores (redness, thickness and scaliness) constituted a Total Sign Score of the scalp ranging from 0 to 12 (0= best;12= worst). Patients with a Total sign score of 0 or 1 at week 4 achieved Success."|4 weeks|||percentage of participants|||Number
826088|NCT01195831|Secondary|"Patients With Controlled Disease in Term of Clear or Very Mild According to Patient's Global Assessment of Disease Severity at Week 4."|Patients made a global assessment of the disease severity by use of a 5-point scale (Clear, Very Mild, Mild, Moderate, Severe). Patients classifying their disease as Clear or Very Mild at week 4 were rated as having Controlled disease. This assessment was made prior to the investigator's assessments.|4 weeks|||percentage of participants|||Number
826089|NCT01195831|Secondary|Patients With “Controlled Disease” in Terms of “Clear” or “Very Mild” According to Patient’s Global Assessment of Disease Severity at Week 2.|Patients made a global assessment of the disease severity by use of a 5-point scale (Clear, Very Mild, Mild, Moderate, Severe). Patients classifying their disease as Clear or Very Mild at week 2 were rated as having Controlled disease. This assessment was made prior to the investigator's assessments.|2 weeks|||percentage of participants|||Number
826090|NCT01195831|Secondary|Patients With “Controlled Disease” in Terms of “Clear” or “Minimal” According to Investigator’s Global Assessment of Disease Severity at Week 2|Investigators made a global assessment of the disease severity by use of a 6-point scale (Clear, Minimal, Mild, Moderate, Severe and Very Severe). Patients with disease severity classified as Clear or Minimal disease at week 2 were rated as having Controlled disease.|2 weeks|||percentage of participants|||Number
826091|NCT01195831|Primary|Patients With ”Controlled Disease” in Terms of “Clear” or “Minimal” According to Investigator’s Global Assessment of Disease Severity at Week 4.|Investigators made a global assessment of the disease severity by use of a 6-point scale (Clear, Minimal, Mild, Moderate, Severe and Very Severe). Patients with disease severity classified as Clear or Minimal disease after the treatment period (week 4) were rated as having Controlled disease.|4 weeks|||percentage of parcipitants|||Number
826092|NCT01195844|Primary|The Number of Deaths in Hospitalized Participants Enrolled in the Study|The number of deaths among children up to 5 years of age hospitalized for diarrhea in the 4 Brazilian hospital research centers. Diarrhea was defined as the passage of 3 or more soft/liquid feces in a 24-hour period.|1 year|Participants were not followed-up in the study; thus the number of deaths was not known.|||||
826170|NCT01196104|Secondary|Week 16 Change From Baseline in Forced Expiratory Volume in 1 Second|Week 16 Change from Baseline in FEV1|Baseline to Week 16|Safety Population, with data available at Week 16||L||Standard Deviation|Mean
826093|NCT01195844|Primary|The Duration of Hospitalization for Participants Enrolled in the Study|The mean duration (days) of hospital stay for children up to 5 years of age hospitalized for diarrhea in the 4 Brazilian hospital research centers. Diarrhea was defined as the passage of 3 or more soft/liquid feces in a 24-hour period.|From hospital admission to discharge|The population analyzed was all enrolled participants whether or not a fecal sample was obtained.||days||Standard Deviation|Mean
826094|NCT01195844|Primary|The Numbers of Participants Hospitalized for Diarrhea and Rotavirus-caused Diarrhea Per Month|Children up to 5 years of age hospitalized for diarrhea were tested for fecal rotavirus as determined by enzyme immunoassay. Diarrhea was defined as the passage of 3 or more soft/liquid feces in a 24-hour period.|1 year|The population analyzed was all enrolled participants whether or not a fecal sample was obtained||Participants|||Number
826095|NCT01195844|Primary|The Number of Hospitalizations for Diarrhea That Are Caused by Rotavirus by Age Group|Children up to 5 years of age hospitalized for diarrhea were tested for fecal rotavirus as determined by enzyme immunoassay. Diarrhea was defined as the passage of 3 or more soft/liquid feces in a 24-hour period. The number of hospitalizations for diarrhea from rotavirus infection was reported for each age group.|1 year|The population analyzed was the 27 of 190 participants who had a fecal sample positive for rotavirus.||participants|||Number
826096|NCT01195844|Primary|The Percentage of Hospitalizations for Diarrhea That Are Caused by Rotavirus|Children up to 5 years of age hospitalized for diarrhea were tested for fecal rotavirus as determined by enzyme immunoassay. Diarrhea was defined as the passage of 3 or more soft/liquid feces in a 24-hour period. The number of hospitalizations for diarrhea from rotavirus infection was divided by the total number of hospitalizations for diarrhea in the 4 hospital research centers.|1 year|Children hospitalized for diarrhea and providing a fecal sample in the 4 Brazilian hospital research centers||percentage of participants||95% Confidence Interval|Number
826097|NCT01195844|Primary|The Geographic Distribution of Hospitalizations for Diarrhea That Are Caused by Rotavirus|Children up to 5 years of age hospitalized for diarrhea were tested for fecal rotavirus as determined by enzyme immunoassay. Diarrhea was defined as the passage of 3 or more soft/liquid feces in a 24-hour period. For each geographic location, the number of hospitalizations for diarrhea that was caused by rotavirus was reported.|1 year|The population analyzed was children up to 5 years of age hospitalized for diarrhea. A total of 190 of the 230 participants had fecal samples analyzed; 27 of these had stool samples positive for rotavirus.||Participants|||Number
826098|NCT01195844|Primary|The Percentage of Hospitalizations for Diarrhea in Children up to 5 Years of Age|The percentage of total hospitalizations for children up to 5 years of age in the 4 Brazilian hospital research centers that were for diarrhea. Diarrhea was defined as the passage of 3 or more soft/liquid feces in a 24-hour period.|1 year|"The population to be analyzed was all hospitalizations for any reason for children up to 5 years of age in the 4 hospital research centers
The number of total hospitalizations for children up to 5 years of age was not known; thus this outcome measure was not evaluated"|||||
826099|NCT01195844|Primary|The Number of Hospitalizations for Diarrhea in Children up to 5 Years of Age|The total number of hospitalizations for diarrhea in children up to 5 years of age in the 4 Brazilian hospital research centers was reported. Diarrhea was defined as the passage of 3 or more soft/liquid feces in a 24-hour period.|1 year|The population analyzed was all enrolled participants whether or not a fecal sample was obtained||participants|||Number
826100|NCT01195922|Primary|Percent (%) Change in Clinical and Laboratory Evaluations for Safety||Percent (%) change from Pre to Post treatement (~21 days)|Same sample loss during processing for phosphor and magnesium||percentage change from baseline||Standard Deviation|Mean
826101|NCT01195922|Primary|Percent (%) Changes in Tumor Size, Blood Flow, and Standardized Uptake Value||21 days post treatment with rapamycin|It was not possible to obtain appropriate CT scans or SUV measurement from all participants||percentage change from baseline||Standard Deviation|Mean
826102|NCT01195922|Primary|Percent (%) Change in Levels of pS6, pAKt473, and Ki-67||21 days post treatment with rapamycin|paraffin embedded formalin fixed tissues including head and neck cancer lesion were not available for 2 participants||percentage of change from baseline||Standard Deviation|Mean
826103|NCT01195948|Secondary|Changes in High-speed Indocyanine Green Angiography (HS-ICG)||Week 24||||||
826104|NCT01195948|Secondary|Reduction in Exposure to Corticosteroid as Measured by the Area Under the Dose-time Curve.||Week 24||||||
826105|NCT01195948|Secondary|Number of Participants Presenting No Change in Autofluorescence Patterns as Observed on Fundus Autofluorescence (FAF) at Week 24 Compared to Baseline||Week 24|Thirty (30) participants completed Week 24. One placebo participant was lost to follow-up at Week 10.||participants|||Number
826106|NCT01195948|Secondary|Number of Participants Presenting No Change in Retinal Vessel Leakage Observed by Fluorescein Angiography (FA) at Week 24 Compared to Baseline||Week 24|Thirty (30) participants completed Week 24. One placebo participant was lost to follow-up at Week 10.||participants|||Number
826107|NCT01195948|Secondary|Mean Change in Best-Corrected Visual Acuity (BCVA) in Left Eye (OS) at Week 24 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 24|Thirty (30) participants completed Week 24. One placebo participant was lost to follow-up at Week 10.||ETDRS letters||Full Range|Mean
826108|NCT01195948|Secondary|Mean Change in Best-Corrected Visual Acuity (BCVA) in Right Eye (OD) at Week 24 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 24|Thirty (30) participants completed Week 24. One placebo participant was lost to follow-up at Week 10.||ETDRS letters||Full Range|Mean
826109|NCT01195948|Secondary|Proportion of Participants Determined to be a Treatment Failure, Defined as Recurrent (or Flare) of Uveitis or a Drop in Visual Acuity of ≥ 15 Early Treatment Diabetic Retinopathy Study (ETDRS) Letters|Recurrent (or flare) of uveitis is defined as at least a 2-step increase in anterior chamber cells and/or vitreous haze using the Standardization of Uveitis Nomenclature (SUN) grading system|Week 52|Twenty-five (25) participants completed Week 52. Three completed prior to Week 52 as a result of early study closure (1/group), two placebo participants and one 4 mg participant were lost to follow-up at Weeks 10, 44 and 28, respectively.||participants|||Number
826110|NCT01195948|Secondary|Proportion of Participants Determined to be a Treatment Failure, Defined as Recurrent (or Flare) of Uveitis or a Drop in Visual Acuity of ≥ 15 Early Treatment Diabetic Retinopathy Study (ETDRS) Letters|Recurrent (or flare) of uveitis is defined as at least a 2-step increase in anterior chamber cells and/or vitreous haze using the Standardization of Uveitis Nomenclature (SUN) grading system|Week 24|Thirty (30) participants completed Week 24. One placebo participant was lost to follow-up at Week 10.||participants|||Number
826111|NCT01195948|Primary|The Primary Outcome is the Time to Recurrence of Uveitis in Participants of Each Treatment Group, During or After Tapering of Oral Prednisone to a Dose of 7.5 mg/Day, or Equipotent Dose of Alternative Corticosteroid Medication.|"Recurrence (or flare) is defined as an anterior chamber cells and/or vitreous haze grading of ≥ 2+ using the Standardization of Uveitis Nomenclature (SUN) grading system.
The time to this event is defined as the time from randomization to recurrence, loss to follow-up or end of study, whichever comes first. Participants that do not present with disease recurrence will be censored at the time of the last disease evaluation."|Time from randomization to recurrence, loss to follow-up, or end of study, up to 52 weeks|||weeks||Inter-Quartile Range|Median
826112|NCT01196026|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs: medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Up to Month 6|The analysis was performed on the Total Vaccinated Cohort which included all subjects with study vaccine administered.||subjects|||Number
826113|NCT01196026|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs: medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Up to Day 28|The analysis was performed on the Total Vaccinated Cohort which included all subjects with study vaccine administered.||subjects|||Number
826114|NCT01196026|Secondary|Number of Subjects Reporting Medically-Attended Events (MAEs), Adverse Events of Specific Interest (AESIs)/ Potential Immune Mediated Diseases (pIMDs) and Adverse Events (AEs) of Special Interest|"MAEs: subject received medical attention defined as hospitalisation, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason.
AESIs/pIMD: includes both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Adverse events of special interest include both convulsion and anaphylaxis."|During the entire study period (up to Month 6)|The analysis was performed on the Total Vaccinated Cohort which included all subjects with study vaccine administered.||subjects|||Number
826115|NCT01196026|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|"Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Any was defined as any symptom regardless of intensity or relationship to vaccination. Grade 3 was a symptom preventing normal everyday activity. Related was any symptom assessed by the investigator as causally related to the study vaccination."|During a 28 day follow-up period (Day 0-27) after vaccination|The analysis was performed on the Total Vaccinated Cohort which included all subjects with study vaccine administered.||subjects|||Number
826116|NCT01196026|Secondary|Duration of Any Solicited General Symptom Experienced by Subjects Above 6 Years Old|Duration was expressed as median number of days the symptom persisted. Solicited general symptoms assessed include fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever.|During a 7-day follow-up period (Day 0-6) after vaccination|The analysis was performed on the Total Vaccinated Cohort, on subjects aged above 6 years that had completed their symptom sheet for the respective vaccine dose only.||days||Inter-Quartile Range|Median
826117|NCT01196026|Secondary|Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, sweating and fever. Any was defined as any symptom regardless of intensity; any fever was axillary temperature greater than or equal to 37.5 degrees celsius. Grade 3 was a symptom preventing normal everyday activity; grade 3 fever was axillary temperature above 39 degrees celsius. Related was any symptom assessed by the investigator as causally related to the study vaccination.|During a 7-day follow-up period (Day 0-6) after vaccination|The analysis was performed on the Total Vaccinated Cohort, on subjects aged above 6 years that had completed their symptom sheet for the respective vaccine dose only.||subjects|||Number
826118|NCT01196026|Secondary|Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old|Duration was expressed as median number of days the symptom persisted. Solicited general symptoms assessed include diarrhoea, drowsiness, irritability, loss of appetite and fever.|During a 7-day follow-up period (Day 0-6) after vaccination|The analysis was performed on the Total Vaccinated Cohort, on subjects aged less than 6 years that had completed their symptom sheet for the respective vaccine dose only.||days||Inter-Quartile Range|Median
826119|NCT01196026|Secondary|Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms assessed include diarrhoea, drowsiness, irritability, loss of appetite and fever. Any was defined as any symptom regardless of intensity; any fever was axillary temperature greater than or equal to 37.5 degrees celsius. Grade 3 was a symptom preventing normal everyday activity; grade 3 loss of appetite was not eating at all; grade 3 fever was axillary temperature above 39 degrees celsius. Related was any symptom assessed by the investigator as causally related to the study vaccination.|During the 7 days (Days 0–6) after vaccination|The analysis was performed on the Total Vaccinated Cohort, on subjects aged less than 6 years that had completed their symptom sheet for the respective vaccine dose only.||subjects|||Number
826120|NCT01196026|Secondary|Duration of Any Solicited Local Symptom|Duration was expressed as median number of days the symptom persisted. Solicited local symptoms assessed include: pain, redness and swelling.|During the 7 days (Days 0 – 6) after vaccination|The analysis was performed on the Total Vaccinated Cohort, on subjects that had completed their symptom sheet and reported the respective symptom only.||days||Inter-Quartile Range|Median
826171|NCT01196104|Secondary|Week 16 Forced Expiratory Volume in 1 Second|Week 16 FEV1|Week 16|Safety Population, with data available at Week 16||L||Standard Deviation|Mean
826172|NCT01196104|Secondary|Baseline Forced Expiratory Volume in 1 Second (FEV1)|Baseline FEV1|Baseline|Safety Population||L||Standard Deviation|Mean
826121|NCT01196026|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed include: pain, redness and swelling. Any is any symptom regardless of intensity. Grade 3 was defined as a symptom that prevented normal activity.above 50 millimeter.|During the 7 days (Day 0 – 6) after vaccination|The analysis was performed on the Total Vaccinated Cohort, on subjects that had completed their symptom sheet for the respective vaccine dose only.||subjects|||Number
826122|NCT01196026|Secondary|Number of Subjects Seroconverted for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine|"Seroconverted subject was a subject with a minimum 4-fold increase in titer at post-vaccination for neutralizing antibody response.
Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine."|Month 6|Analysis was performed on According-to-Protocol (ATP) cohort for persistence at Month 6 which included all evaluable subjects for whom immunogenicity data at Month 6 were available.||subjects|||Number
826123|NCT01196026|Secondary|Number of Subjects Seroconverted for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains in Subjects Receiving Fluarix|Seroconverted subject was a subject with a minimum 4-fold increase in titer at post-vaccination for neutralizing antibody response.|Day 28|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available. Analysis was done only on those groups receiving the Fluarix vaccine.||subjects|||Number
826124|NCT01196026|Secondary|Number of Subjects Seropositive for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine|Seropositivity was defined as antibody titers greater than or equal to 1:28. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine.|Day 0 and Month 6|Analysis was performed on According-to-Protocol (ATP) cohort for persistence at Month 6 which included all evaluable subjects for whom immunogenicity data at Month 6 were available.||subjects|||Number
826125|NCT01196026|Secondary|Number of Subjects Seropositive for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains|Seropositivity was defined as antibody titers greater than or equal to 1:28.|Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only)|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available. Analysis was done only on those groups receiving the Fluarix vaccine.||subjects|||Number
826126|NCT01196026|Secondary|Serum Neutralising Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine|Antibody titers were expressed as GMTs.] Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine.|Day 0 and Month 6|Analysis was performed on According-to-Protocol (ATP) cohort for persistence at Month 6 which included all evaluable subjects for whom immunogenicity data at Month 6 were available.||titer||95% Confidence Interval|Geometric Mean
826127|NCT01196026|Secondary|Serum Neutralising Antibody Titers Against All Fluarix Vaccine Strains|Antibody titers were expressed as Geometric Mean Titers (GMTs).|Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only)|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available. Analysis was done only on those groups receiving the Fluarix vaccine.||titer||90% Confidence Interval|Geometric Mean
826128|NCT01196026|Secondary|Mean Geometric Increase (MGI) in HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine|"MGI is defined as the geometric mean of the within-subject ratios of the post-vaccination (Month 6) reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer.
Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine."|Month 6|Analysis was performed on According-to-Protocol (ATP) cohort for persistence at Month 6 which included all evaluable subjects for whom immunogenicity data at Month 6 were available.||ratio||95% Confidence Interval|Geometric Mean
826129|NCT01196026|Secondary|Mean Geometric Increase (MGI) in HI Antibody Titers Against All Fluarix Vaccine Strains in All Subjects Receiving Fluarix Vaccine|MGI is defined as the geometric mean of the within-subject ratios of the post-vaccination (Day 28) reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains.|Day 28|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available. Analysis was done only on those groups receiving the Fluarix vaccine.||ratio||95% Confidence Interval|Geometric Mean
826130|NCT01196026|Secondary|Number of Subjects Seroprotected for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine|A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine.|Day 0 and Month 6|Analysis was performed on According-to-Protocol (ATP) cohort for persistence at Month 6 which included all evaluable subjects for whom immunogenicity data at Month 6 were available.||subjects|||Number
826131|NCT01196026|Secondary|Number of Subjects Seroprotected for HI Antibodies Against All Fluarix Vaccine Strains|A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains.|Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only)|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available.||subjects|||Number
826132|NCT01196026|Secondary|Number of Subjects Seroconverted for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine|"A seroconverted subject was defined as a subject that had either a pre-vaccination (Day 0) titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer.
Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine."|Month 6|Analysis was performed on According-to-Protocol (ATP) cohort for persistence at Month 6 which included all evaluable subjects for whom immunogenicity data at Month 6 were available.||subjects|||Number
826133|NCT01196026|Secondary|Number of Subjects Seroconverted for HI Antibodies Against All Fluarix Vaccine Strains in All Subjects Receiving Fluarix Vaccine|"A seroconverted subject was defined as a subject that had either a pre-vaccination (Day 0) titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer.
Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains."|Day 28|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available. Analysis was done only on those groups receiving the Fluarix vaccine.||subjects|||Number
826134|NCT01196026|Secondary|Number of Subjects Seropositive for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine|Seropositivity was defined as antibody titers greater than or equal to 1:10. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine.|Day 0 and Month 6|Analysis was performed on According-to-Protocol (ATP) cohort for persistence at Month 6 which included all evaluable subjects for whom immunogenicity data at Month 6 were available.||subjects|||Number
826135|NCT01196026|Secondary|Number of Subjects Seropositive for HI Antibodies Against All Fluarix Vaccine Strains|Seropositivity was defined as antibody titers greater than or equal to 1:10. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains.|Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only)|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available.||subjects|||Number
826136|NCT01196026|Secondary|HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine|Antibody titers were expressed as GMTs. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine.|Day 0 and Month 6|Analysis was performed on According-to-Protocol (ATP) cohort for persistence at Month 6 which included all evaluable subjects for whom immunogenicity data at Month 6 were available.||titer||95% Confidence Interval|Geometric Mean
826137|NCT01196026|Secondary|HI Antibody Titers Against All Fluarix Vaccine Strains|Antibody titers were expressed as GMTs. Vaccine strains included in the analysis were Flu A/CAL/7/09 H1N1 , FluB/Bri/60/08 Victoria, and Flu A/Vic/210/09 H3N2, further in this summary denoted as H1N1, Victoria and H3N2 strains, respectively.|Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only)|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available.||titer||95% Confidence Interval|Mean
826138|NCT01196026|Primary|Mean Geometric Increase (MGI) in HI Antibody Titers Against H1N1 in All Subjects Receiving Fluarix Vaccine|MGI is defined as the geometric mean of the within-subject ratios of the post-vaccination (Day 28) reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer.|Day 28|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available. The data presented here are only for the Fluarix All Ages Group. Similar data for other groups will be presented as Secondary Outcome Measure.||ratio||95% Confidence Interval|Geometric Mean
826139|NCT01196026|Primary|Number of Subjects Seroconverted for HI Antibodies Against H1N1 in All Subjects Receiving Fluarix Vaccine|A seroconverted subject was defined as a subject that had either a prevaccination (Day 0) titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer.|Day 28|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available. The data presented here are only for the Fluarix All Ages Group. Similar data for other groups will be presented as Secondary Outcome Measure.||subjects|||Number
826140|NCT01196026|Primary|Number of Subjects Seroprotected for HI Antibodies Against H1N1 in All Subjects Receiving Fluarix Vaccine|A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.|Day 0-28|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available. The data presented here are only for the Fluarix All Ages Group. Similar data for other groups will be presented as Secondary Outcome Measure.||subjects|||Number
826141|NCT01196026|Primary|Number of Subjects Seropositive for HI Antibodies Against H1N1 in All Subjects Receiving Fluarix Vaccine|Seropositivity was defined as antibody titers greater than or equal to 1:10.|Day 0-28|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available. The data presented here are only for the Fluarix All Ages Group. Similar data for other groups will be presented as Secondary Outcome Measure.||subjects|||Number
826142|NCT01196026|Primary|Haemagglutination Inhibition (HI) Antibody Titers Against H1N1 in All Subjects Receiving Fluarix Vaccine|Antibody titers were expressed as Geometric mean titers (GMTs).|Day 0 and 28|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available. The data presented here are only for the Fluarix All Ages Group. Similar data for other groups will be presented as Secondary Outcome Measure.||titer||95% Confidence Interval|Geometric Mean
826143|NCT01196052|Secondary|Disease-free Survival at Month 12|Disease-free survival was defined as the time from date of first protocol treatment for adjuvant patients or date of surgery for neoadjuvant patients to disease recurrence, occurrence of invasive contralateral breast cancer, other second primary cancer (excluding non-breast second primary), or death, whichever occurred first.|From the start of trastuzumab emtansine for adjuvant patients and from the date of surgery for neoadjuvant patients to 12 months later|"Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine.
Due to too few events, the analysis of disease-free survival was not performed."|||||
826173|NCT01196104|Secondary|Number of Cough Episodes Occuring Within 10 Minutes of Drug Inhalation||Baseline to Week 16|Safety Population||Cough episodes|||Number
826174|NCT01196104|Secondary|Number of Single Coughing Episodes|Total number of times patients coughed only once|Baseline to Week 16|Safety Population||Cough episodes|||Number
826144|NCT01196052|Secondary|Percentage of Participants With a Pathological Complete Response|Pathological complete response was defined as the absence of invasive neoplastic cells at microscopic examination of the primary tumor and lymph nodes after surgery following primary systemic therapy. Pathological complete response was evaluated in participants treated with neoadjuvant therapy doxorubicin/cyclophosphamide-5-fluorouracil/epirubicin/cyclophosphamide followed by 1 or more doses of trastuzumab emtansine and who underwent surgery.|Day of surgery|Efficacy analysis population: All participants who enrolled in the neoadjuvant setting and received surgery, after completing 4 cycles of trastuzumab emtansine treatment.||Percentage of participants||95% Confidence Interval|Number
826145|NCT01196052|Secondary|Percentage of Participants Who Completed ≥ 95% of the Planned Radiotherapy Treatment With Concurrent Trastuzumab Emtansine Administration Without Significant (> 5 Days) Delay||From the start to the end of radiotherapy treatment (up to 51 weeks)|Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. Only participants who received concurrent radiotherapy and who had radiotherapy dose information reported were included in the analysis.||Percentage of participants|||Number
826146|NCT01196052|Secondary|Percentage of Participants Who Completed the Planned Duration of Trastuzumab Emtansine Treatment|Participants were to receive up to a total of 17 cycles of trastuzumab emtansine. If trastuzumab was given concurrently with either the optional docetaxel or optional radiation, then the number of 3-week cycles of trastuzumab therapy was subtracted from the planned 17 cycles of trastuzumab emtansine therapy.|From the start to the end of trastuzumab emtansine treatment (up to 51 weeks)|Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine.||Percentage of participants|||Number
826147|NCT01196052|Secondary|Percentage of Participants Who Experienced at Least 1 Adverse Event During Concurrent Hormonal Therapy With Trastuzumab Emtansine Treatment||From the start to the end of concurrent hormonal therapy (up to 51 weeks)|Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. Only participants who received concurrent hormonal therapy were included in the analysis.||Percentage of participants|||Number
826148|NCT01196052|Secondary|Percentage of Participants Who Experienced at Least 1 Adverse Event During Concurrent Radiotherapy With Trastuzumab Emtansine Treatment||From the start to the end of concurrent radiotherapy (up to 51 weeks)|Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. Only participants who received concurrent radiotherapy were included in the analysis.||Percentage of participants|||Number
826149|NCT01196052|Primary|Adverse Events, LVEF Function, and Deaths|The following percentages of participants are reported: At least 1 adverse event while receiving T-DM1; at least 1 serious adverse event while receiving T-DM1; an adverse event leading to discontinuation, dose delay, or dose reduction of trastuzumab emtansine treatment; symptomatic cardiac dysfunction; and asymptomatic decline in left ventricular ejection fraction (LVEF). An asymptomatic LVEF decline was defined as a LVEF < 50% and a maximum decrease ≥ 10% from Baseline. The percentage of participants who died is reported.|From the start to the end of trastuzumab emtansine treatment (up to 51 weeks)|Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine.||Percentage of participants|||Number
826150|NCT01196052|Primary|Percentage of Participants With a Cardiac Event Within 12 Weeks After the Start of Trastuzumab Emtansine Treatment|A cardiac event was defined as death from a cardiac cause or severe congestive failure (New York Heart Association [NYHA] Class III or IV) with a decrease in left ventricular ejection fraction (LVEF) of ≥ 10% from Baseline to an LVEF of < 50%.|Baseline to 12 weeks after the start of trastuzumab emtansine treatment|Cardiac-safety evaluable population: All participants who received at least 1 dose of T-DM1 and met either of the following 2 criteria: (1) Had an echocardiogram/multiple-gated acquisition assessment by 12 weeks after the first dose of T-DM1 or (2) discontinued study treatment because of cardiac toxicity prior to completion of 4 cycles of T-DM1.||Percentage of participants||95% Confidence Interval|Number
826151|NCT01196078|Secondary|Percentage of Participants With Changes in FACT-L (Lung Symptoms) by Category of Change|The LCS consists of 7 items of the FACT-L (3 items relating to breathing/dyspnea, and 1 item each relating to cough, weight loss, appetite, and cognition). The LCS total score is the sum of the scores from the 7 items, each rated on a five-point scale from 0 (not at all) to 4 (very much). For clear thinking and good appetite, the higher score represented 'Improved'; for other subscales and questionnaires, the higher score represented 'Worsened'. For each FACT-L question, the response status was defined as down, up, or no change if the score at endpoint was smaller (score down), larger than (score up), or the same as (no change) that at baseline.|Baseline and End of study|Safety Population; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
826152|NCT01196078|Secondary|Changes in Quality of Life as Assessed by FACT-L (Lung Symptoms) Questionnaire|The LCS consists of 7 items of the FACT-L (3 items relating to breathing/dyspnea, and 1 item each relating to cough, weight loss, appetite, and cognition) rated on a five-point scale from 0 (not at all) to 4 (very much). The LCS total score is the sum of the scores from the 7 items. For clear thinking and good appetite, the higher score represented 'Improved'; for other subscales and questionnaires, the higher score represented 'Worsened'. Missing data were replaced by the valid post-baseline assessment before. The change of FACT-L subscore was the change from baseline to endpoint. The LCS of FACT-L is an independently validated tool that measures the disease-related symptoms of lung cancer on an overall scale of 0 (most symptomatic) to 28 (asymptomatic).|Baseline and Day 1 of Cycles 2, 3, 4, 5, 6 and End of study|Safety Population; n=number of participants assessed for the specified parameter at a given visit.||units on a scale||Standard Deviation|Mean
826153|NCT01196078|Secondary|Percentage of Participants With Changes in Quality of Life as Measured by FACT Questionnaire Scores by Category of Change|The FACT and the FACT-L contain 4 general and 1 lung cancer symptom-specific subscale, including PWB, SWB, EWB, FWB, and the 8-item LCS that assess symptoms commonly reported by participants with lung cancer. For subscales of FWB and SWB, questionnaires of EWB, and additional concerns questions, the higher score represented 'Improved'. For other subscales and questionnaires, the higher score represented Worsened'. For PWB, FWB, SWB, and EWB scores and disease-specific subscale score, higher scores indicated a better outcome; a response of down, up, or no change was defined as a score change of ≤ -2 (score down), ≥ +2 (score up), or between these values.|Baseline and End of study|Safety Population; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
826154|NCT01196078|Secondary|Changes in Quality of Life as Measured by the FACT Questionnaire|The FACT Questionnaire contains 4 general and 1 lung cancer symptom-specific subscale, including PWB, SWB, EWB, FWB, and the 8-item LCS that assess symptoms commonly reported by participants with lung cancer. Each subscale was assessed by a five-point scale from 0 (not at all) to 4 (very much) to determine the quality of life. PWB, SWB and FWB scores ranged from 0-28 and EWB scores ranged from 0-24. LCS scores ranged from 0-36. For subscales of FWB and SWB, questionnaires of EWB, and additional concerns questions, the higher score represented 'Improved'. For other subscales and questionnaires, the higher score represented 'Worsened'. Missing data were replaced by the valid post-baseline assessment before. For PWB, FWB, SWB, and EWB scores and disease-specific subscale score, response of down, up or no change were defined as score changes of less than or equal to (≤)2, greater than or equal to (≥)+2, or between these values.|Baseline and Day 1 of Cycles 2, 3, 4, 5, 6 and End of study|Safety Population; n=number of participants assessed for the specified parameter at a given visit.||units on a scale||Standard Deviation|Mean
826155|NCT01196078|Secondary|Quality of Life as Measured by the Functional Assessment of Cancer Therapy (FACT) Questionnaire|The FACT Questionnaire contains 4 general and 1 lung cancer symptom-specific subscale, including Physical Well-Being (PWB), Social/family Well-Being (SWB), Emotional Well-Being (EWB), Functional Well-Being (FWB), and the 8-item Lung Cancer Subscale (LCS) that assess symptoms commonly reported by participants with lung cancer. Each subscale was assessed by a five-point scale from 0 (not at all) to 4 (very much) to determine the quality of life. PWB, SWB and FWB scores ranged from 0-28 and EWB scores ranged from 0-24. LCS scores ranged from 0-36. For subscales of FWB and SWB, questionnaires of EWB, and additional concerns questions, the higher score represented 'Improved'. For other subscales and questionnaires, the higher score represented 'Worsened'. Missing data were replaced by the valid post-baseline assessment before. The FACT-L score ranges from 0 to 136, with higher scores indicating better quality of life.|Baseline and Day 1 of Cycles 2, 3, 4, 5, 6 and End of study|Safety Population; n=number of participants assessed for the specified parameter at a given visit.||units on a scale||Standard Deviation|Mean
826156|NCT01196078|Secondary|Overall Survival: Time to Event|Overall survival was defined as the time from the date of randomization to the date of death. Participants who were alive at the time of the analysis were censored at the date of the last follow-up assessment. Participants without follow-up assessment were censored at the day of last dose and participants with no post baseline information were censored at the time of randomization. Overall median time to event was assessed for the population that experienced an event.|Day 1 of Cycles 1 through 6 to date of death or date of last follow-up assessment|ITT population||months||95% Confidence Interval|Median
826157|NCT01196078|Secondary|Overall Survival: Percentage of Participants With an Progressive Disease or Death|Overall survival was defined as the time from the date of randomization to the date of death. Participants who were alive at the time of the analysis were censored at the date of the last follow-up assessment. Participants without follow-up assessment were censored at the day of last dose and participants with no postbaseline information were censored at the time of randomization. Progressive disease was defined per RECIST as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Day 1 of Cycles 1 through 6 to date of death or date of last follow-up assessment|ITT population||percentage of participants|||Number
826158|NCT01196078|Secondary|Time to Disease Progression|Time to disease progression was defined as the interval between the day of randomization and the first documentation of progressive disease or death.|Day 1 of Cycles 1, 3, and 5 or first documentation of progressive disease or death|ITT population||months||95% Confidence Interval|Median
826159|NCT01196078|Secondary|Percentage of Participants With Disease Progression|Progressive disease was defined using RECIST as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Day 1 of Cycles 1, 3, and 5 or first documentation of progressive disease or death|ITT population||percentage of participants|||Number
826160|NCT01196078|Secondary|Duration of Response Among Participants Who Achieved Either a CR or PR|Duration of response was defined similarly for complete and partial responders. Complete response lasted from the date the complete response was first recorded to the date on which progressive disease was first noted or date of death. Partial response lasted from the date of partial response to the date of the first observation of progressive disease or date of death.|Screening, Day 1 of Cycles 3 and 5, every 4th cycle during post-study treatment, and every 3 cycles during follow-up|ITT population; only participants with a response (CR or PR) were included in the analysis.||months||95% Confidence Interval|Median
826161|NCT01196078|Secondary|Percentage of Participants Achieving Disease Control|Disease control was defined as achieving a best overall response of CR, PR, or stable disease (SD) according to RECIST criteria. Participants with tumor assessment unevaluable were viewed as uncontrolled.|Screening, Day 1 of Cycles 3 and 5 and at End of treatment up to 1 year|ITT Population||percentage of participants|||Number
826162|NCT01196078|Primary|Percentage of Participants Achieving a Best Overall Response of Complete Response (CR) or Partial Response (PR)|CR was defined as disappearance of all target lesions. PR was defined as at least a 30 percent (%) decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Participants experiencing either a CR or PR according to Response Evaluation Criteria in Solid Tumors (RECIST) were classified as responders. Participants with tumour assessment unevaluable were viewed as non-responders.|Screening, Day 1 of Cycles 3 and 5 and at End of treatment up to 1 year|ITT population||percentage of participants|||Number
826163|NCT01196104|Secondary|Week 20 (Follow-up) Change From Baseline in Forced Vital Capacity|Week 20 (Follow-up, 4 weeks after discontinuation of study treatment) Change from Baseline in FVC|Baseline to Week 20|Safety Population, with data available at Week 20||L||Standard Deviation|Mean
826164|NCT01196104|Secondary|Week 20 (Follow-up) Forced Vital Capacity|Week 20 (Follow-up, 4 weeks after discontinuation of study treatment) FVC|Week 20|Safety Population, with data available at Week 20||L||Standard Deviation|Mean
826165|NCT01196104|Secondary|Week 16 Change From Baseline Forced Vital Capacity|Week 16 Change from Baseline FVC|Baseline to Week 16|Safety Population, with data available at Week 16||L||Standard Deviation|Mean
826166|NCT01196104|Secondary|Week 16 Forced Vital Capacity|Week 16 FVC|Week 16|Safety Population, with data available at Week 16||L||Standard Deviation|Mean
826167|NCT01196104|Secondary|Baseline Forced Vital Capacity (FVC)|Baseline FVC|Baseline|Safety Population||L||Standard Deviation|Mean
826177|NCT01196104|Secondary|Mild or Moderate Hypoglycemic Event Rate|"Mild or moderate hypoglycemic event rate, ie, total number of events divided by subject-months of observation
Nonsevere hypoglycemia is defined as a subject:
SMBG levels < 70 mg/dL AND/OR
Symptoms that are relieved by the self-administration of carbohydrates"|Baseline to Week 16|Safety Population||Events / subject-month|||Number
826178|NCT01196104|Secondary|Severe Hypoglycemic Event Rate|"Severe hypoglycemic event rate, ie, total number of events divided by subject-months of observation
Severe hypoglycemia is defined as a subject who requires the assistance of another individual (not merely requested) and either:
SMBG levels ≤ 36 mg/dL OR
There is a prompt response to the administration of carbohydrate, glucagon, or other resuscitative measures"|Baseline to Week 16|Safety Population||Events / subject-month|||Number
826179|NCT01196104|Secondary|Total Number of Cough Episodes|Total number of times patients coughed once, intermittently or continuously (inclusive)|Baseline to Week 16|Safety Population||Cough episodes|||Number
826180|NCT01196104|Secondary|Treatment Satisfaction as Assessed by Subject Treatment and Health Outcomes Questionnaires|Not analyzed due to early termination of the trial.|Change from baseline to 16 weeks||||||
826181|NCT01196104|Secondary|Changes in Body Weight at 16 Weeks|Not analyzed due to early termination of the trial.|Change from baseline to 16 weeks||||||
826182|NCT01196104|Secondary|Glycemic Excursions and Variability as Assessed Through Continuous Glucose Monitoring (CGM)|Not analyzed due to early termination of the trial.|Change from baseline to 16 weeks||||||
826183|NCT01196104|Secondary|Seven-point Glucose at Randomization and Throughout the Study|Not analyzed due to early termination of the trial.|Change from baseline to 16 weeks||||||
826184|NCT01196104|Secondary|Glycomark and Fructosamine Levels Measured Throughout the Study|Not analyzed due to early termination of the trial.|Change from baseline to 16 weeks||||||
826185|NCT01196104|Secondary|Comparison of Post-prandial Glucose (PPG) Levels at Randomization and Throughout the Study|Not analyzed due to early termination of the trial.|Change from baseline to 16 weeks||||||
826186|NCT01196104|Secondary|Comparison of Fasting Plasma Glucose (FPG) Levels at Randomization and Throughout the Study|Not analyzed due to early termination of the trial.|Change from baseline to 16 weeks||||||
826187|NCT01196104|Secondary|To Evaluate the Effect of Each Treatment on HbA1c|Not analyzed due to early termination of the trial.|Change from baseline to 16 weeks||||||
826188|NCT01196104|Primary|Change in HbA1c (%) From Baseline to Week 16|Change from Baseline in glycated hemoglobin at Week 16|Baseline to Week 16|Safety Population, participants with data available at Baseline and Week 16||Percentage of total hemoglobin||Standard Deviation|Least Squares Mean
826189|NCT01196377|Primary|%FEV1|% predicted forced expiratory volume in 1-second as a measure of airway obstruction|2 hours|||%-predicted||Full Range|Mean
826190|NCT01196429|Secondary|Objective Tumor Response|Complete and Partial Tumor Response by RECIST 1.1. RECIST1.1 is a multi-page paper, and response is defined in the protocol across multiple pages, so it is not practical to define response here.|Every other cycle for first 6 months; then every 3 months for two years; then every six months for the next three years; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tu|Eligible and Treated Patients||percentage of participants||90% Confidence Interval|Number
826191|NCT01196429|Secondary|Overall Survival|Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.|Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years.|Eligible and Treated Patients||months||90% Confidence Interval|Median
826192|NCT01196429|Secondary|Progression-free Survival|Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression was based on RECIST 1.1|Tumor scans were done every other cycle for the first 6 months; then every 3 months x 2; then every 6 mths thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising tumor mark|Eligible and Treated Patients||months||90% Confidence Interval|Median
826193|NCT01196429|Primary|Frequency and Severity of Toxicity|Grade 3 or higher adverse events were graded by CTC AE v4|Each cycle while on treatment|Eligible and Treated Patients||participants|||Number
826194|NCT01196429|Primary|Compare Progression-free Survival in Newly Diagnosed Stage III or IV Clear Cell Ovarian Cancer Patients in Patients in the U.S. and Worldwide (Outside of Japan) Versus Patients in Japan.|"Progression-free survival (PFS) was defined s the period from study entry until disease progression, death, or the last date of contact. Progression was based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. Outcome measure data not reported because protocol stated If the combination is declared active (i.e. HO is rejected) in one or both of the populations, the two populations will be compared with respect to PFS using a logrank test stratified by optimal/suboptimal disease status. The combination was not declared active in either population."|Tumor scans were done every other cycle for the first 6 months;then every 3 mnths x2;then every 6 mnths thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggesting progressive dx or rising serum tumor marker le|"The protocol stated if the combination is declared active (i.e., HO is rejected) in one or both of the populations, the two populations will be compared with respect to PFS using a logrank test stratified by optimal/suboptimal disease status. The combination was not declared active in either population."|||||
826213|NCT01188655|Secondary|Change From Baseline in ASQoL at Week 12 and Week 24|ASQoL is a questionnaire that assesses disease-specific quality of life (QoL). It consists of 18 statements that are relevant to the physical and mental conditions for a participant with AS: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each statement is answered by the participant as a 'Yes' (scored as 1) or 'No' (scored as 0). All item scores are summed to give a total score. Total score can range from 0 (good QoL) to 18 (poor QoL).|Baseline, Week 12 and Week 24|Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point.||Units on a scale||Standard Deviation|Mean
826271|NCT01189136|Other Pre-specified|Questionnaire Data - Impression of Allocation|"Participants were asked to guess to which treatment arm they had been allocated (PTNS Sham or I Don't Know). Outcome was measured as the number of patients in each arm accurately determining their allocation."|30 minutes|Number||number of participants|||Number
826195|NCT01196429|Primary|Proportion of Patients Who Are Alive and Progression-free for at Least 12 Months After Study Entry in Patients With Newly Diagnosed Stage III or IV Clear Cell Ovarian Cancer in the Following Populations: Patients in the U.S./Worldwide and Japan|Progression of target lesions (TL) was a >=20% increase in the sum of the diameters of TL, taking as reference the smallest sum on study (including the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must demonstrate an absolute increase >=5 mm. Progression of non-target lesions (NTL) as defined as appearance of >=1 new lesions or unequivocal progression of existing NTL. Unequivocal progression should not normally trump target lesion status; it must be representative of overall disease status change, not a single lesion increase. Clear progression of only NTL is exceptional, but the opinion of the treating physician should prevail in such circumstances, and the progression status should be later confirmed by a review panel (or Principal Investigator). Progression of TL, unequivocal progression of NTL, or new lesions constitutes progression. This description is abbreviated; see the RECIST 1.1 manuscript for further details.|Tumor scans were done every other cycle for the first 6 months; then every 3 months x2; then every 6 months thereafter; and at any other time if clinically indicated or signs suggestive of progressive disease or rising levels; for up to 5 years.|Eligible and Treated Patients||percentage of participants||90% Confidence Interval|Number
826196|NCT01196442|Secondary|Effect of Electric Stimulation Pain Therapy on Other Non-pain Symptoms at Month 3|Chemotherapy-induced peripheral neuropathy (CIPN)-20. The CIPN-20 has 3 subscales: a sensory, motor, and autonomic subscale. There are 17 questions that are rated 0-not at all to 3-very much. Scales are summed. Final score ranges from 0-51, 0 as the best possible outcome and 51 as the worst.|Month 3|||units on a scale||Standard Error|Least Squares Mean
826197|NCT01196442|Secondary|Effect of Electric Stimulation Pain Therapy n Other Non-pain Symptoms at Month 2|Chemotherapy-induced peripheral neuropathy (CIPN)-20. The CIPN-20 has 3 subscales: a sensory, motor, and autonomic subscale. There are 17 questions that are rated 0-not at all to 3-very much. Scales are summed. Final score ranges from 0-51, 0 as the best possible outcome and 51 as the worst.|month 2|||units on a scale||Standard Error|Least Squares Mean
826198|NCT01196442|Secondary|Effect of Electric Stimulation Pain Therapy on Other Non-pain Symptoms at Month 1|Chemotherapy-induced peripheral neuropathy (CIPN)-20. The CIPN-20 has 3 subscales: a sensory, motor, and autonomic subscale. There are 17 questions that are rated 0-not at all to 3-very much. Scales are summed. Final score ranges from 0-51, 0 as the best possible outcome and 51 as the worst.|month 1|||units on a scale||Standard Error|Least Squares Mean
826199|NCT01196442|Secondary|Effect of Electric Stimulation Pain Therapy on Other Non-pain Symptoms at Day 10|Chemotherapy-induced peripheral neuropathy (CIPN)-20. The CIPN-20 has 3 subscales: a sensory, motor, and autonomic subscale. There are 17 questions that are rated 0-not at all to 3-very much. Scales are summed. Final score ranges from 0-51, 0 as the best possible outcome and 51 as the worst.|Day 10|||units on a scale||Standard Error|Least Squares Mean
826200|NCT01196442|Secondary|Use of Medications Including Morphine Oral Dose Equivalents, Anti-depressants, and Neuroleptics|Record daily pain medication usage and convert all opioids to MOEDs (American Pain Society 2003). Compare the average daily use prior to day 1 to the average daily use day 30. Range is 0-none to 240-most|From day 1 to day 30|||doses||Standard Deviation|Mean
826201|NCT01196442|Secondary|Effect of Electrical Stimulation Pain Therapy on Other Non-pain Symptoms at Day 1|Chemotherapy-induced peripheral neuropathy (CIPN)-20. The CIPN-20 has 3 subscales: a sensory, motor, and autonomic subscale. There are 17 questions that are rated 0-not at all to 3-very much. Scales are summed. Final score ranges from 0-51, 0 as the best possible outcome and 51 as the worst.|Day 1|Participants at Day 1||units on a scale||Standard Error|Least Squares Mean
826202|NCT01196442|Primary|Change in Pain Score From Day 1 to Day 10|"Change in Brief Pain Inventory (Now)Scale
1 (none) to 5 (complete interference)"|From day 1 to day 10|||units on a scale||Standard Deviation|Mean
826203|NCT01188603|Primary|Flibanserin: Tmax,ss|Median of the tmax,ss of Flibanserin|8 days|All patients with values for the time from dosing to the maximum measured concentration of flibanserin in plasma after single dose at steady state (tmax,ss)||h||Full Range|Median
826204|NCT01188603|Primary|Flibanserin: Cmax,ss|Geometric mean of the Cmax,ss of Flibanserin|8 days|All patients with values for the maximum concentration of Flibanserin in plasma after single dose at steady state (Cmax,ss)||ng/mL||Geometric Coefficient of Variation|Geometric Mean
826205|NCT01188603|Primary|Flibanserin: Cmax (Peak Concentration)|Geometric mean of the Cmax of Flibanserin|8 days|All patients with values for the maximum concentration of Flibanserin in plasma after single dose (Cmax)||ng/mL||Geometric Coefficient of Variation|Geometric Mean
826206|NCT01188603|Primary|Flibanserin: AUC τ,ss|Geometric mean of the AUC τ,ss of Flibanserin|8 days|All patients with values for the area under the concentration-time curve of the analyte in plasma over a dosing interval τ at steady state (AUC τ,ss)||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
826207|NCT01188603|Primary|Flibanserin: Area Under the Curve; AUC_0-∞|Geometric mean of the AUC_0-∞ of Flibanserin|8 days|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
826208|NCT01188655|Secondary|Spine Agility Function by Ott Test|The Ott index determines the agility of the thoracic spine.|Week 12 and Week 24|Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point||cm||Standard Deviation|Mean
826209|NCT01188655|Secondary|Spine Agility Function by Schober Test|Schober test determines agility of lumbar spine. It measures participant’s ability to flex the lower back. Examiner makes a mark at fifth lumbar vertebra (L5); places 1 finger 5 cm below and another 10 cm above the mark. Participant is asked to touch the toes. Examiner measures the increase in distance between 2 fingers.|Week 12 and Week 24|Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point||cm||Standard Deviation|Mean
826210|NCT01188655|Secondary|Mean Occiput-to-wall Distance at Week 12 and Week 24||Week 12 and Week 24|Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point||cm||Standard Deviation|Mean
826211|NCT01188655|Secondary|Percentage of Participants Without Peripheral Arthritis||Week 12 and Week 24|Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point.||Percentage of Participants|||Number
826214|NCT01188655|Secondary|Mean Duration of Morning Stiffness|Duration of morning stiffness is defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes (24h x 60 minutes) was recorded).|Week 12 and Week 24|Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point.||minutes||Standard Deviation|Mean
826215|NCT01188655|Secondary|Physician's Global Assessment Visual Analog Scale at Weeks 12 and 24|Physician Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm= no disease activity.|Week 12 and Week 24|Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point.||mm||Standard Deviation|Mean
826216|NCT01188655|Secondary|Participant's Global Assessment Visual Analog Scale at Weeks 12 and 24|Measured using a 100mm VAS ranging from 0=very good to 100=very bad.|Week 12 and Week 24|Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point.||Units on a scale||Standard Deviation|Mean
826217|NCT01188655|Secondary|Change From Baseline in the BASFI at Weeks 12 and 24|BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.|Baseline, Week 12 and Week 24|Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point.||Units on a scale||Standard Deviation|Mean
826218|NCT01188655|Secondary|Change From Baseline in BASDAI at Week 12 and 24|BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The final BASDAI score averages the individual assessments for a final score range of 0-10.|Baseline, Week 12 and Week 24|Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point.||units on a scale||Standard Deviation|Mean
826219|NCT01188655|Primary|Percentage of Participants Achieving BASDAI 40 Response at Week 24|BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The final BASDAI score averages the individual assessments for a final score range of 0-10. Participants who achieved a decrease of 40 percent or more from baseline to the following visits are called as responders.|Week 24|Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point||Percentage of participants|||Number
826220|NCT01188668|Secondary|Plasma Dehydro-aripiprazole (Metabolite) Concentration Versus Time Summary: Aripiprazole 5mg, DVS SR 100 mg, Aripiprazole 5 mg|Summary statistics were to be calculated by setting concentration values below the lower limit of quantification (LLQ = 0.100 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) = 0.|Period 1 / Day 1 and Period 2 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing|PK concentration analysis population: all randomized and treated participants who had at least 1 concentration in at least 1 treatment period. Period 2 / Day 1 = Day 1 of Aripiprazole dosing (Period 2 / Day 7) within the DVS SR, Aripiprazole coadministration dosing period.||ng/mL||Full Range|Median
826221|NCT01188668|Secondary|Plasma Aripiprazole Concentration Versus Time Summary: Aripiprazole 5mg, DVS SR 100 mg + Aripiprazole 5 mg|Summary statistics were to be calculated by setting concentration values below the lower limit of quantification (LLQ = 0.100 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) = 0.|Period 1 / Day 1 and Period 2 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing|PK concentration analysis population: all randomized and treated participants who had at least 1 concentration in at least 1 treatment period. Period 2 / Day 1 = Day 1 of Aripiprazole dosing (Period 2 / Day 7) within the DVS SR, Aripiprazole coadministration dosing period.||ng/mL||Full Range|Median
826222|NCT01188668|Secondary|Dehydro-aripiprazole (Metabolite) Apparent Volume of Distribution (Vz/F) Following Aripiprazole Alone and When Coadministered With DVS SR||Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20|PK parameter analysis population. Data was insufficient for analysis; not analyzable.||liters||Standard Deviation|Geometric Mean
826223|NCT01188668|Secondary|Dehydro-aripiprazole (Metabolite) Apparent Clearance (CL/F) Following Aripiprazole Alone and When Coadministered With DVS SR|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood calculated as (Dose/AUCinf).|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20|PK parameter analysis population. Data was insufficient for analysis; not analyzable.||mL/min||Standard Deviation|Geometric Mean
826224|NCT01188668|Secondary|Dehydro-aripiprazole (Metabolite) Terminal Half-life (t 1/2) Following Aripiprazole Alone and When Coadministered With DVS SR|Terminal half-life is the time measured for the plasma concentration to decrease by one half.|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20|PK parameter analysis population. N=Number of participants contributing to the mean.||hours||Standard Deviation|Mean
826237|NCT01188772|Secondary|Percentage of Participants Who Developed Resistance to Sofosbuvir|Resistance monitoring was completed in all subjects who received sofosbuvir and who had non-response, viral rebound, virologic breakthrough, or HCV RNA plateaus between Day 0 and Week 24.|Baseline to Week 12|Participants in the Safety Analysis Set who received a regimen containing sofosbuvir were analyzed.||percentage of participants|||Number
826225|NCT01188668|Secondary|Dehydro-aripiprazole (Metabolite) Time for Cmax (Tmax) Following Aripiprazole Alone and When Coadministered With DVS SR|Time for maximum observed plasma concentration.|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20|PK parameter analysis population. N=number of participants contributing to the mean.||hours||Full Range|Median
826226|NCT01188668|Secondary|Dehydro-aripiprazole (Metabolite) Maximum Observed Plasma Concentration (Cmax) Following Aripiprazole Alone and When Coadministered With DVS SR||Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing|PK parameter analysis population. N=number of participants contributing to the mean.||ng/mL||Standard Deviation|Geometric Mean
826227|NCT01188668|Secondary|Dehydro-aripiprazole (Metabolite) Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Aripiprazole Alone and When Coadministered With DVS SR|Dehydro-aripiprazole is a metabolite of Aripiprazole. Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20|PK parameter analysis population. N=Number of participants contributing to the mean.||ng*hr/mL||Standard Deviation|Geometric Mean
826228|NCT01188668|Secondary|Aripiprazole Apparent Volume of Distribution (Vz/F) Following Aripiprazole Alone and When Coadministered With DVS SR|Calculated as Dose / (AUCinf * kel); where kel=terminal phase rate constant.|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20|PK parameter analysis population. N=Number of participants contributing to the mean.||liters||Standard Deviation|Geometric Mean
826229|NCT01188668|Secondary|Aripiprazole Apparent Clearance (CL/F) Following Aripiprazole Alone and When Coadministered With DVS SR|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood calculated as (Dose/AUCinf); measured as milliliters per minute (mL/min).|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20|PK parameter analysis population. N=Number of participants contributing to the mean.||mL/min||Standard Deviation|Geometric Mean
826230|NCT01188668|Secondary|Aripiprazole Terminal Half-life (t 1/2) Following Aripiprazole Alone and When Coadministered With DVS SR|Terminal half-life is the time measured for the plasma concentration to decrease by one half.|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20|PK parameter analysis population. N=Number of participants contributing to the mean.||hours||Standard Deviation|Mean
826231|NCT01188668|Secondary|Aripiprazole Time for Cmax (Tmax) Following Aripiprazole Alone and When Coadministered With DVS SR|Time for maximum observed plasma concentration.|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20|PK parameter analysis population. N=Number of participants contributing to the median.||hours||Full Range|Median
826232|NCT01188668|Secondary|Aripiprazole Maximum Observed Plasma Concentration (Cmax) Following Aripiprazole Alone and When Coadministered With DVS SR|Cmax measured as nanograms per milliliters (ng/mL).|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20|PK parameter analysis population. N=Number of participants contributing to the mean.||ng/mL||Standard Deviation|Geometric Mean
826233|NCT01188668|Primary|Aripiprazole Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Aripiprazole Alone and When Coadministered With DVS SR|Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞); measured as nanograms multiplied by hours divided by milliliters (ng*hr/mL).|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20|Pharmacokinetic (PK) parameter analysis population: all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. N=Number of participants contributing to the mean.||ng*hr/mL||Standard Deviation|Geometric Mean
826234|NCT01188681|Secondary|Response Per NCI Criteria|Overall response rate per National Cancer Institute (NCI) Working group criteria.|1 and 2 months after end of treatment, then every 3 months until disease progression, death, initiation of new therapy, study withdrawal, or 2 years|Safety data for all patients who received any study drug and efficacy data for randomized patients who received some study treatment and have some post baseline data are presented here.||percentage of patients|||Number
826235|NCT01188681|Primary|Response Per International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Criteria|Patients had full clinical response assessment monthly during treatment, at the end of treatment (EOT) visit, 30 and 60 days after the EOT visit, and subsequently every 3 months until the earliest of progression of CLL, death, initiation of new therapy, withdrawal from the study, or completion of 18 months of follow-up evaluations. Clinical response assessment included physical examination with measurement of spleen, liver, and lymph nodes, disease-related symptoms, and laboratory measurements, specifically complete blood count (CBC) with differential.|1 and 2 months after end of treatment, then every 3 months until disease progression, death, initiation of new therapy, study withdrawal, or 2 years|Treated patients||percentage of patients|||Number
826236|NCT01188694|Primary|PTSD Symptom Severity-Interview (PSS-I)|PTSD Symptom Scale - Interview Version, higher scores represent higher PTSD severity (range 0 - 51)|Pre-treatment, post-treatment (4 weeks from pre-), 1-month follow-up (from post-), and 3-month follow-ups (from post-)|Intent to Treat||units on a scale||Standard Deviation|Mean
826238|NCT01188772|Secondary|Plasma Pharmacokinetics of GS-331007 (AUCtau at Day 29)|The pharmacokinetics of sofosbuvir metabolite GS-331007 were analyzed as the the area under the plasma concentration versus time curve over the dosing interval (AUCtau) at Day 29. Blood samples were collected at 1, 2, and 4 hours postdose for all participants, and at 8 and 12 hours postdose for participants enrolled at selected sites.|1, 2, 4, 8, and 12 hours postdose|Participants who had measurements of pharmacokinetic parameters at Day 29 were analyzed.||ng•h/mL||Standard Deviation|Mean
826239|NCT01188772|Secondary|Plasma Pharmacokinetics of GS-331007 (AUCtau at Day 15)|The pharmacokinetics of sofosbuvir metabolite GS-331007 were analyzed as the the area under the plasma concentration versus time curve over the dosing interval (AUCtau) at Day 15. Blood samples were collected at 1, 2, and 4 hours postdose for all participants, and at 8 and 12 hours postdose for participants enrolled at selected sites.|1, 2, 4, 8, and 12 hours postdose|Participants who had measurements of pharmacokinetic parameters at Day 15 were analyzed.||ng•h/mL||Standard Deviation|Mean
826240|NCT01188772|Secondary|Plasma Pharmacokinetics of GS-331007 (AUCtau at Day 8)|The pharmacokinetics of sofosbuvir metabolite GS-331007 were analyzed as the the area under the plasma concentration versus time curve over the dosing interval (AUCtau) at Day 8. Blood samples were collected at 1, 2, and 4 hours postdose for all participants, and at 8 and 12 hours postdose for participants enrolled at selected sites.|1, 2, 4, 8, and 12 hours postdose|Participants who had measurements of pharmacokinetic parameters at Day 8 were analyzed.||ng•h/mL||Standard Deviation|Mean
826241|NCT01188772|Secondary|Plasma Pharmacokinetics of GS-331007 (Cmax at Day 29)|The pharmacokinetics of sofosbuvir metabolite GS-331007 were analyzed as the Cmax at Day 29. Blood samples were collected at 1, 2, and 4 hours postdose for all participants, and at 8 and 12 hours postdose for participants enrolled at selected sites.|1, 2, 4, 8, and 12 hours postdose|Participants who had measurements of pharmacokinetic parameters at Day 29 were analyzed.||ng/mL||Standard Deviation|Mean
826242|NCT01188772|Secondary|Plasma Pharmacokinetics of GS-331007 (Cmax at Day 15)|The pharmacokinetics of sofosbuvir metabolite GS-331007 were analyzed as the Cmax at Day 15. Blood samples were collected at 1, 2, and 4 hours postdose for all participants, and at 8 and 12 hours postdose for participants enrolled at selected sites.|1, 2, 4, 8, and 12 hours postdose|Participants who had measurements of pharmacokinetic parameters at Day 15 were analyzed.||ng/mL||Standard Deviation|Mean
826243|NCT01188772|Secondary|Plasma Pharmacokinetics of GS-331007 (Cmax at Day 8)|The pharmacokinetics of sofosbuvir metabolite GS-331007 were analyzed as the maximum observed concentration of drug in plasma (Cmax) at Day 8. Blood samples were collected at 1, 2, and 4 hours postdose for all participants, and at 8 and 12 hours postdose for participants enrolled at selected sites.|1, 2, 4, 8, and 12 hours postdose|Participants who had measurements of pharmacokinetic parameters at Day 8 were analyzed.||ng/mL||Standard Deviation|Mean
826244|NCT01188772|Secondary|Percentage of Participants With Sustained Virologic Response at Post-treatment Week 12 (SVR12) and 24 (SVR24)|SVR12 and SVR24 were defined as HCV RNA below the limit of detection (< 15 IU/mL) at post-treatment Weeks 12 and 24, respectively.|Post-treatment Weeks 12 and 24|Safety Analysis Set||percentage of participants|||Number
826245|NCT01188772|Secondary|Percentage of Participants With Virologic Response at the End of Treatment|End-of-treatment virologic response was defined as HCV RNA below the limit of detection (< 15 IU/mL) at the last on-treatment visit.|Week 48 (genotype 1) or Week 12 (genotype 2/3)|Participants in the Safety Analysis Set with available data were analyzed. One participant in the Sofosbuvir 400 mg (Genotype 2/3) Group was lost to follow up before the end of treatment and is not included in this analysis.||percentage of participants|||Number
826246|NCT01188772|Secondary|Percentage of Participants With Extended Rapid Virologic Response|Extended rapid virologic response was defined as HCV RNA below the limit of detection (< 15 IU/mL) at Week 4 (Day 29) which was maintained through Week 12.|Week 4 to Week 12|Safety Analysis Set||percentage of participants|||Number
826247|NCT01188772|Secondary|Percentage of Participants With Complete Early Virologic Response at Week 12|Complete early virologic response was defined as HCV RNA below the limit of detection (< 15 IU/mL) at Week 12|Week 12|Safety Analysis Set||percentage of participants|||Number
826248|NCT01188772|Secondary|Percentage of Participants With Rapid Virologic Response at Week 4|Rapid virologic response was defined as HCV RNA below the limit of detection (< 15 IU/mL) at Week 4 (Day 29)|Week 4|Safety Analysis Set||percentage of participants|||Number
826249|NCT01188772|Secondary|Change in HCV RNA From Baseline to Week 12||Baseline to Week 12|Participants in the Safety Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
826250|NCT01188772|Primary|Percentage of Participants Who Experienced Adverse Events During the Sofosbuvir Treatment Period|Adverse events (AEs) occurring during the sofosbuvir treatment period and for 30 days following the last dose of sofosbuvir were summarized across the participant population. A participant was counted once if they had a qualifying event.|Baseline to Week 12 plus 30 days|Safety Analysis Set: participants were randomized and received at least one dose of study drug||percentage of participants|||Number
826251|NCT01188798|Secondary|Assess Overall Survival, Relapse, Engraftment, and Regimen-related Morbidity and Estimating Cumulative Incidence of Pulmonary Adverse Events and Mucositis.|To characterize the pharmacokinetic-pharmacodynamic relationships of pentostatin in this patient population and to assess the relationship between pre-transplant minimal residual disease (MRD) and transplant outcomes.|42 days post- transplant|Insufficient data was available to answer objectives.|||||
826252|NCT01188798|Primary|Determining Whether the Hepatic Adverse Event-free (NCI Grades II-IV) Survival at Day 42 After an HLA-matched Transplant for Hematologic Malignancy Can be Improved by Using a GVHD Prophylaxis Regimen That Includes Pentostatin Rather Than MTX.|The hypothesis was that individuals receiving the drug pentostatin as GVHD prophylaxis would experience less severe hepatic toxicity than those receiving methotrexate as GVHD prophylaxis. The study is estimated to have sufficient statistical power to ascertain at least a 20% improvement in day 42 grade 2 or above hepatic toxicity-free survival in pentostatin recipients|42 days post-transplant|Insufficient data was available to answer objectives|||||
826253|NCT01188811|Secondary|Safety Measure: Adverse Events||adverse events recorded from baseline to year 2|Intention-to-treat analysis was performed on 27 participants in the lipoic acid group and 24 in the placebo group.||occurences|||Number
826254|NCT01188811|Secondary|Disability Measures: Mobility||Change in Timed 25 Foot Walk from baseline to year 2|Outliers were removed and intention-to-treat analysis was performed on data from 21 participants in the lipoic acid group and 17 in the placebo group.||seconds||Standard Deviation|Mean
826256|NCT01188928|Secondary|Mean Percentage Change in PASI From Baseline to Week 8|At all treatment phase visits the (sub)investigator made an assessment of the extent and severity of clinical signs of the subject’s psoriasis using a modified PASI score (Psoriasis Area and Severity Index) To make up the score, the three features of a psoriatic plaque redness, scaling and thickness are each assigned a number from 0 to 4 with 4 being worst. The extent of involvement of each region of the body is scored from 0 to 6. Adding up the scores give a range of 0 to 72.|Baseline and 8 weeks|||percentage of change in PASI||Standard Deviation|Mean
826257|NCT01188928|Secondary|Mean Percentage Change in PASI From Baseline to Week 4|At all treatment phase visits the (sub)investigator made an assessment of the extent and severity of clinical signs of the subject’s psoriasis using a modified PASI score (Psoriasis Area and Severity Index) To make up the score, the three features of a psoriatic plaque redness, scaling and thickness are each assigned a number from 0 to 4 with 4 being worst. The extent of involvement of each region of the body is scored from 0 to 6. Adding up the scores give a range of 0 to 72.|Baseline and 4 weeks|||percentage of change in PASI||Standard Deviation|Mean
826258|NCT01188928|Primary|Controlled Disease According to the Investigator’s Global Assessment of Disease Severity (IGA) at Weeks 8|The IGA was chosen as the primary efficacy assessment. The primary endpoint is subjects with ‘Controlled disease’ according to the IGA. ‘Controlled disease’ is defined as clear or almost clear for subjects with moderate disease at baseline and clear for subjects with mild disease at baseline.|week 8|||participants|||Number
826259|NCT01188928|Primary|Controlled Disease According to the Investigator’s Global Assessment of Disease Severity (IGA) at Weeks 4|The IGA was chosen as the primary efficacy assessment. The primary endpoint is subjects with ‘Controlled disease’ according to the IGA. ‘Controlled disease’ is defined as clear or almost clear for subjects with moderate disease at baseline and clear for subjects with mild disease at baseline.|4 weeks|||participants|||Number
826260|NCT01188967|Secondary|Number of Participants With 7-day, Point-prevalence Tobacco Abstinence 2-weeks After Discontinuation of Double Blind Study Medications|"The hypothesis is that those assigned to GSK598809 will demonstrate a higher rate of biochemically-verified, 7-day, point-prevalence tobacco abstinence than those assigned to identical placebo two weeks after discontinuation of double blind study medications.
7-day, Point-prevalence tobacco abstinence was defined as not smoking for the 7 consecutive days before this visit after discontinuation of double blind study medications"|Week 10 of the study|7 participants completed this visit.||Participants|||Count of Participants
826261|NCT01188967|Secondary|7-day, Point-prevalence Tobacco Abstinence at the End of 6 Weeks Exposure to GSK598809/Placebo|The hypothesis is that those assigned to GSK598809 will demonstrate a higher rate of biochemically-verified, 7-day, point-prevalence tobacco abstinence than those assigned to identical placebo at the end of 6 weeks exposure to GSK598809/placebo.|Week 8 of the study|7 participants completed week 6 weeks exposure to GSK598809/placebo.||Participants|||Count of Participants
826262|NCT01188967|Secondary|7-day, Point-prevalence Tobacco Abstinence at the End of the First Week of Exposure to GSK598809/Placebo|The hypothesis is that those assigned to GSK598809 will demonstrate a higher rate of biochemically-verified, 7-day, point-prevalence tobacco abstinence than those assigned to identical placebo at the end of the first week of exposure to GSK598809/placebo.|Week 3 of the study|13 participants completed week 1 visit||Participants|||Count of Participants
826263|NCT01188967|Primary|4-week, Continuous Tobacco Abstinence at the End of the 6-week, Double Blind, Treatment Phase|The hypothesis is that those assigned to GSK598809 will demonstrate a higher rate of biochemically-verified, 4-week, continuous tobacco abstinence than those assigned to identical placebo at the end of the 6-week, double blind, treatment phase. Four-week continuous abstinence will be defined as Timeline Followback Calendar confirmation at study visit of smoking no cigarettes in the past 7 days, and expired air CO<10ppm for 4 consecutive weeks (the last 4 weeks of the randomized phase)|Week 8 of the study|9 participants completed this visit||Participants|||Count of Participants
826264|NCT01189032|Primary|Mean Change in Fluorescein Staining Score From Baseline|"Fluorescein staining was scored according to the protocol by Shimmura et al. The cornea was divided into 3 equal zones: upper, middle, and lower. Each zone had a staining score ranging between 0 and 3 points, with minimum and maximum total staining scores ranging between 0 and 9 points. 0 is better.
The degree of staining with Fluorescein dyes was scored as follows: 0 = no staining, 1= staining of less than half of the area, 2= staining of more than half of the area, 3= staining in the whole area."|Baseline and 4-week (discontinued(LOCF))|"Efficacy analysis was performed per protocol set (PPS). Excluded cases were 7 subjects (3 subjects in 3% group, 3 subjects in 1% group, and 1 subject in Placebo group).
The reason of exclusion: used the prohibited concomitant drug, dosing period shortage, number of doses non-compliance, or had no available efficacy data."||points||Standard Deviation|Mean
826265|NCT01189071|Secondary|Decreased Use of Narcotic and Anticholinergic Medication Use Postoperatively.|"Decreased use of narcotic and anticholinergic medication use postoperatively, compared to the standard of care patient"|end of study with 30 patients recruited|Three participants were recruited to the study, but no data were collected or analyzed as the author of the study left the institution and the study was terminated.|||||
826266|NCT01189071|Primary|Decreased Post Operative Ureteral Stent Pain, Evidenced by Decreased Pain Scores, Less ER Visits/Hospital Admits, or Patient Phone Calls for Stent Pain/Difficulty|"Decreased post operative ureteral stent pain, evidenced by decreased pain scores, less ER visits/hospital admits, or patient phone calls for stent pain/difficulty, as compared to the standard of care patient with no preop Darifenacin"|24 months|Three participants were recruited to the study, but no data were collected or analyzed as the author of the study left the institution and the study was terminated.|||||
826267|NCT01189110|Primary|Percentage of Self-reported Abstinence at 6 Weeks.|Percentage of study participants free from smoking at 6 weeks based on self-report (yes/no).|6 weeks|A middle-aged, US military veteran population not free of smoking (at least 10 cigarettes per day) and not currently in reciept of any other form of smoking cessation intervention.||percentage of participants||95% Confidence Interval|Number
826268|NCT01189123|Secondary|Antibody Responses|Hemagglutination inhibition antibody titers measured for standard vs high dose|2 years|||GMT||95% Confidence Interval|Geometric Mean
826269|NCT01189123|Primary|Cellular Immune Response|comparison of CMI in high vs standard dose|3 years|A subset of samples were chosen for testing since not enough money was available to test samples from all subjects. The samples were divided by randomization group (blinded to study staff -- they were called group A or group B). From each group, samples were randomly pulled.||percentage of Stimulated cells||Inter-Quartile Range|Median
826272|NCT01189136|Secondary|Amount of Improvement in Voiding Efficiency|Improvement of voiding efficiency, as measured by dividing the volume voided by the total volume (voided volume + retained volume) per participant. Each participant is evaluated separately, and the mean percentage of improvement was calculated for each arm.|30 minutes|||percentage of voided vol/total volume||Standard Deviation|Mean
826273|NCT01189136|Primary|Persistent Retention|Number of participants with persistent unsuccessful trial of void after the intervention|30 minutes|||participants|||Number
826274|NCT01189201|Secondary|Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Blood Chemistry and Assessment of Tolerability by the Investigator|Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Blood Chemistry and Assessment of Tolerability by the Investigator. New abnormal findings or worsening of baseline conditions were reported as Adverse Events. Time frame for adverse event was until the end-of-study examination.|Drug administration until next treatment period/end-of-study examination, up to 36 days|Treated set (TS) included all subjects who were documented to have taken at least one dose of investigational treatment.||participants|||Number
826275|NCT01189201|Primary|Linagliptin Formulation Comparison: Area Under the Curve 0 to 72 Hours (AUC0-72)|"Area under the concentration-time curve of linagliptin in plasma over the time interval from 0 to 72 hours.
In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
826276|NCT01189201|Primary|Linagliptin Formulation Comparison: Maximum Measured Concentration (Cmax)|"Maximum measured concentration of linagliptin in plasma.
In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
826277|NCT01189201|Secondary|Linagliptin Formulation Comparison: Area Under the Curve 0 to Infinity (AUC0-∞)|"Area under the concentration-time curve of linagliptin in plasma over the time interval from 0 extrapolated to infinity.
In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
826278|NCT01189201|Primary|Empagliflozin Formulation Comparison: Area Under the Curve 0 to the Last Quantifiable Drug Plasma Concentration (AUC0-tz)|"Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 to the last quantifiable drug plasma concentration.
In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
826279|NCT01189201|Primary|Empagliflozin Formulation Comparison: Maximum Measured Concentration (Cmax)|"Maximum measured concentration of empagliflozin (empa) in plasma.
In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
826280|NCT01189201|Secondary|Empagliflozin Formulation Comparison: Area Under the Curve 0 to Infinity (AUC0-∞)|"Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity.
In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
826281|NCT01189201|Primary|Linagliptin Fed vs Fasted: Area Under the Curve 0 to 72 Hours (AUC0-72)|"Area under the concentration-time curve of linagliptin in plasma over the time interval from 0 to 72 hours.
In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
826721|NCT01200069|Secondary|Incidence of Headache & Severity Headache After ECT Treatment #3|Subject self reported numerical rating of incidence and severity of post ECT headache after treatment #3, 0=no pain, 2-4=moderate pain, 5-7=distressing severe pain, 8-9 very serious pain, 10=unbearable pain.|1 hour after treatment, 6 hours, 24 hours and 48 hours|||units on a scale||Full Range|Mean
826282|NCT01189201|Primary|Linagliptin Fed vs Fasted: Maximum Measured Concentration (Cmax)|"Maximum measured concentration of linagliptin in plasma.
In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
826283|NCT01189201|Secondary|Linagliptin Fed vs Fasted: Area Under the Curve 0 to Infinity (AUC0-∞)|"Area under the concentration-time curve of linagliptin in plasma over the time interval from 0 extrapolated to infinity.
In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
826284|NCT01189201|Primary|Empagliflozin Fed vs Fasted: Area Under the Curve 0 to the Last Quantifiable Drug Plasma Concentration (AUC0-tz)|"Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 to the last quantifiable drug plasma concentration.
In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
826285|NCT01189201|Primary|Empagliflozin Fed vs Fasted: Maximum Measured Concentration (Cmax)|"Maximum measured concentration of empagliflozin (empa) in plasma, comparing fed with fasted.
In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
826286|NCT01189201|Secondary|Empagliflozin Fed vs Fasted: Area Under the Curve 0 to Infinity (AUC0-∞)|"Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity.
In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
826287|NCT01189201|Secondary|Linagliptin: Area Under the Curve 0 to Infinity (AUC0-∞)|"Area under the concentration-time curve of linagliptin in plasma over the time interval from 0 extrapolated to infinity.
In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
826288|NCT01189201|Secondary|Empagliflozin: Area Under the Curve 0 to Infinity (AUC0-∞)|"Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity.
In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
826289|NCT01189201|Secondary|Linagliptin: Time From Last Dosing to Maximum Measured Concentration (Tmax)|Time from last dosing to the maximum measured concentration of linagliptin in plasma|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.||hours||Full Range|Median
826290|NCT01189201|Secondary|Empagliflozin: Time From Last Dosing to Maximum Measured Concentration (Tmax)|Time from last dosing to the maximum measured concentration of empagliflozin (empa) in plasma.|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.||hours||Full Range|Median
826722|NCT01200069|Secondary|Incidence and Severity of Headache After ECT Treatment 2|Subject self reported numerical rating of incidence and severity of post ECT headache 0=no pain, 2-4=moderate pain, 5-7= distressing severe pain, 8-9= very severe pain, 10=unbearable pain.|1 hour, 6 hour, 24 hour and 48 hours|||units on a scale||Full Range|Mean
826291|NCT01189201|Primary|Linagliptin: Maximum Measured Concentration (Cmax)|"Maximum measured concentration of linagliptin in plasma.
In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
826292|NCT01189201|Primary|Empagliflozin: Maximum Measured Concentration (Cmax)|"Maximum measured concentration of empagliflozin (empa) in plasma.
In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
826293|NCT01189201|Primary|Linagliptin: Area Under the Curve 0 to 72 Hours (AUC0-72)|"Area under the concentration-time curve of linagliptin in plasma over the time interval from 0 to 72 hours.
In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
826294|NCT01189201|Primary|Empagliflozin: Area Under the Curve 0 to the Last Quantifiable Drug Plasma Concentration (AUC0-tz)|"Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 to the last quantifiable drug plasma concentration.
In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
826295|NCT01189227|Secondary|Frequencies of Adverse Events as Assessed by the NCI CTCAE v4.0||From study entry through 3 months after the last treatment dose.||||||
826296|NCT01189227|Secondary|Frequencies of Selected Postoperative Surgical Complications and Other Adverse Events Within 30 Days of Surgery||Assessed within 30 days from the time of surgery||||||
826297|NCT01189227|Secondary|The Difference in R0 and Combined R0 + R1 Resection Rates Between the Two Arms.||Assessed at the time of surgery||||||
826298|NCT01189227|Secondary|Overall Survival||From study entry until the time of death or for a maximum of 5 years.||||||
826299|NCT01189227|Secondary|RFS of Patients Event-free||From study entry until the date of recurrence or for a maximum of 6 months.||||||
826300|NCT01189227|Primary|Recurrence-free Survival (RFS)|Time to recurrence or death|From study entry until the date of recurrence or death or for a maximum of 5 years.||||||
826301|NCT01189240|Secondary|Measurement of AUC24 to Determine the Effect of Bevacizumab on the Plasma Pharmacokinetics of RO4929097 Day 15|all pts at all dose levels (5,10 and 20mg) will have pks collected. 10 samples will be collected at various time points over a 24 hour time point. Samples will be collected on the 15th day of treatment during cycle 1.|24hr|Day 15. Only 4 pts samples were evaluable for AUC 24 at the10mg dose.||ng*h/mL||Standard Deviation|Mean
826302|NCT01189240|Secondary|Measurement of AUC24 to Determine the Effect of Bevacizumab on the Plasma Pharmacokinetics of RO4929097 Day 1|all pts at all dose levels (5,10 and 20mg) will have pks collected. 10 samples will be collected at various time points over a 24 hour time point. Samples will be collected on the first day of treatment during cycle 1.|24hrs|Day 1||ng*h/mL||Standard Deviation|Mean
826303|NCT01189240|Secondary|Measurement of Cmax to Determine the Effect of Bevacizumab on the Plasma Pharmacokinetics of RO4929097 Day 15|all pts at all dose levels (5,10 and 20mg) will have pks collected. 10 samples will be collected at various time points over a 24 hour time point. Samples will be collected on the 15th day of treatment during cycle 1.|24hr|Day 15 only. Level 2 10mg only had 5pts with evaluable PKs at day 15||ng/mL||Standard Deviation|Geometric Mean
826304|NCT01189240|Secondary|Measurement of Cmax to Determine the Effect of Bevacizumab on the Plasma Pharmacokinetics of RO4929097 Day 1|"all pts at all dose levels (5,10 and 20mg) will have pks collected. 10 samples will be collected at various time points over a 24 hour time point. Samples will be collected on the first day of treatment during cycle 1.
For initial cycle (Cycle 1) bevacizumab was not given until 2 or 3 days after all PKs samples of initial dose of RO49290977 was collected"|24 hrs|Day One only||ng/mL||Standard Deviation|Geometric Mean
826305|NCT01189240|Secondary|Toxicity Description (Dose Limiting Toxicity-DLT) of Gamma-secretase Inhibitor RO4929097 in Combination With Bevacizumab|Pts were treated at escalating dose levels of RO4929097 (Dose levels: 5, 10 or 20 mg) for an observed evaluation at the end of a 4week period. 3 pts treated at each cohort. Pts must receive one dose of treatment to be evaluated for toxicity. Toxcity description associated with combination of RO4929097 and Bevacizumab|28 days - 1 cycle|DLT Defintion, must be related to RO and/or Bev: ANC </= 500/μL or second time ANC <1,000/μL; PLTs </= 25,000/μL or second time platelets <50,000/μL; Febrile neutropenia;Thrombocytopenic bleeding (platelets <50,000/μL and with clinically significant bleeding); Delay of treatment > 14 days ;grade 3 or 4 non-hematological toxicity (some exceptions)||participants|||Number
826344|NCT01189500|Secondary|N-desmethyl-tamoxifen (Metabolite) Time for Cmax (Tmax) Following Tamoxifen Alone and When Coadministered With DVS SR|Time for maximum observed plasma concentration.|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. N=number of participants contributing to the median.||hours||Full Range|Median
826306|NCT01189240|Primary|Maximum-tolerated Dose and the Recommended Phase II Dose of Gamma-secretase Inhibitor RO4929097 in Combination With Bevacizumab Determined by Dose-limiting Toxicity Rate (Phase I)|Pts were treated at escalating dose levels of RO4929097 (Dose levels: 5, 10 or 20 mg) for an observed evaluation at the end of a 4week period. 3 pts treated at each cohort if less than or equal to 33% dose will be escalated. Pts must receive one dose of treatment to be evaluated for toxicity. A standard 3+3 dose escalation method will be used|28 days|RO4929097 Days 1-3 weekly (doses 5,10, 20 mg) + Bev 10mg/kg IV q2 wks - cycle 28 days. 3+3 dose escalation method will be used. Target DLT is > or equal to 33%||mg|||Number
826307|NCT01189279|Secondary|Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Dermatologist Assessment|Local scalp tolerability by dermatologist assessment is based on a 4-point scale (0=None, 1=Mild, 2=Moderate, and 3=Severe) for 5 symptoms (dryness/scaling, edema, erythema, folliculitis, and pigmentation). An at least 1-grade increase at any timepoint from baseline indicates a worsening of symptoms.|Baseline, 20 Days|Safety Population: all subjects who received at least 1 dose of study medication||Patients|||Number
826308|NCT01189279|Secondary|Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Patient Assessment|Local scalp tolerability by patient assessment is based on a 4-point scale (0=None, 1=Mild, 2=Moderate, and 3=Severe) for 3 symptoms (burning, itching, and stinging). An at least 1-grade increase from baseline at any timepoint indicates a worsening of symptoms.|Baseline, 20 Days|Safety Population: all subjects who received at least 1 dose of study medication||Patients|||Number
826309|NCT01189279|Secondary|Percentage of Patients With Clinically Significant Electrocardiogram (ECG) Findings|An ECG is a tracing of the heart's electrical activity over time in waves with points identified at P, Q, R, S, and T [measured in milliseconds (ms)], as well as the heart rate [measured in beats per minute (bpm)]. Clinically significant abnormal results include maximum post-treatment QTcB>500 ms, maximum post-treatment QTcF>500 ms, maximum post-treatment QT interval >500 ms, PR interval 25% increase from baseline and >200 ms, QRS interval 25% increase from baseline and >100 ms, heart rate 25% increase from baseline and >100 bpm, and heart rate 25% decrease from baseline and <50 bpm.|17 Days|Safety Population: all subjects who received at least 1 dose of study medication||Percentage of Patients|||Number
826310|NCT01189279|Primary|Maximum Plasma Level (Cmax) Following Multiple Doses of Bimatoprost|Cmax is the maximum plasma level following multiple doses of bimatoprost. Plasma is the fluid portion of the blood in which the cells are suspended.|17 Days|Per Protocol: all subjects with no major protocol deviations||Picograms/Milliliter (pg/mL)||Standard Deviation|Mean
826311|NCT01189279|Primary|Maximum Plasma Level (Cmax) Following a Single Dose of Bimatoprost|Cmax is the maximum plasma level following a single dose of bimatoprost. Plasma is the fluid portion of the blood in which the cells are suspended.|Day 1|Per Protocol: all subjects with no major protocol deviations||Picograms/Milliliter (pg/mL)||Standard Deviation|Mean
826312|NCT01189292|Secondary|Necessary Anesthesiological Medication|Compare the amount of necessary anesthesiologic medication during the operation between the treatment (dexamethasone) and the control (saline) group|measured from beginning of anaesthesia to end of anaesthesia|||milligram||Standard Deviation|Mean
826313|NCT01189292|Secondary|Length of Hospital Stay|Compare the lengths of hospital stay between the treatment (dexamethasone) and the control (saline) group|Difference between day of admission and day of discharge|intention to treat||hour||Standard Deviation|Mean
826314|NCT01189292|Secondary|Postoperative Pain After Physical Stress|"Compare grade of pain between the treatment (dexamethasone) and the control (saline) group
Pain was measured using a verbal rating scale ranging from 0 (no pain) to 10 in steps of 1
before obtaining the pain rating, patients were asked to turn their heads (physical stress)"|4 and 8 hours after surgery|intention to treat analysis||units on a scale||Standard Deviation|Mean
826315|NCT01189292|Secondary|Degree of Post Operative Nausea and Vomiting|"mild nausea:......single administration of an antiemetic drug
severe nausea: repeated administration of antiemetic drugs
vomiting:...........at least one vomiting event"|8 hours after surgery|intention to treat||participants|||Number
826316|NCT01189292|Secondary|Degree of Post Operative Nausea and Vomiting|"mild nausea:......single administration of an antiemetic drug
severe nausea: repeated administration of antiemetic drugs
vomiting:...........at least one vomiting event"|4 hours after surgery|intention to treat||participants|||Number
826317|NCT01189292|Secondary|Incidence of Postoperative Nausea and Vomiting|"Compare the postoperative recovery, as determined by postoperative nausea and vomiting (PONV) after preoperative application of single-dose dexamethasone versus saline in patients undergoing partial or total thyroidectomy (primary end-point)
any PONV event within 48 hours after surgery
PONV was measured at 4, 8, 16, 24, 32 and 48 hours after surgery"|within 48 hours after surgery (PP)|per protocol analysis||percentage of participants||95% Confidence Interval|Number
826318|NCT01189292|Primary|Incidence of Postoperative Nausea and Vomiting|"Compare the postoperative recovery, as determined by postoperative nausea and vomiting (PONV) after preoperative application of single-dose dexamethasone versus saline in patients undergoing partial or total thyroidectomy (primary end-point)
any PONV event within 48 hours after surgery
PONV was measured at 4, 8, 16, 24, 32 and 48 hours after surgery"|within 48 hours after surgery|intention to treat analysis||percentage of participants||95% Confidence Interval|Number
826319|NCT01189370|Secondary|Overall Number of Participants That Had Disease Progression on Study|Disease Progression as defined by the Response Evaluation Criteria In Solid Tumors (RECIST) criteria.|26 months|||Participants|||Count of Participants
826320|NCT01189370|Primary|Number of Participants Who Could Tolerate Each Dose Level|Tolerability will be defined as successful completion of the dose level without experiencing Grade 3 or 4 toxicity.|12 weeks|||Participants|||Count of Participants
826321|NCT01189435|Primary|To Examine the Objective Response Rate (ORR) of Single-agent Erlotinib|in recurrent EGFR-mutant lung cancer, given to patients who previously received adjuvant erlotinib or gefitinib|2 years||||||
826342|NCT01189500|Secondary|N-desmethyl-tamoxifen (Metabolite) Apparent Clearance (CL/F) Following Tamoxifen Alone and When Coadministered With DVS SR|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood calculated as (Dose/AUCinf); measured as milliliters per minute (mL/min).|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. Data was insufficient for analysis; not analyzable.||mL/min||Standard Deviation|Geometric Mean
826322|NCT01189461|Secondary|Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at Week 48 (End of Treatment)|VA indicated sharpness or clarity of vision. BCVA assessed by early treatment diabetic retinopathy study chart using 4 meter (m), 1m distance, or if participant was able to count fingers, perceive hand motion or light. At 4m (>= 20 letters), VA score=number of letters correct plus 30 (credited for 30 letters at 1m); otherwise , VA score=number of letters read correctly at 1m plus number read at 4m (if any). If no letters were read correctly at 4m or 1m, VA score= 0, which were excluded from summary statistics calculation. BVCA score ranged: 0 (poor eyesight) to 78 (best eyesight).|Baseline, Week 48 (End of treatment)|Full analysis set included all enrolled participants who received at least 1 dose of study medication. Here 'N' (number of participants analyzed) signifies participants who had BVCA score greater than 0 at baseline and 'n' signifies those who were evaluable at each specified time point.||units on a scale||Standard Deviation|Mean
826323|NCT01189461|Primary|Mean Total Number of Injections|Mean number of injections per participant was calculated as (number of injection administered per participant – 1)/duration of treatment. Mean number of injections administered for total participants was summarized.|Baseline up to Week 48 (End of treatment)|Safety analysis set included all enrolled participants who received at least 1 dose of study medication.||injections||Standard Deviation|Mean
826324|NCT01189461|Secondary|Incidence of Ocular and Non-Ocular Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Total number of participants who had ocular and non-ocular SAEs was reported.|Baseline up to 30 days after last dose|Safety analysis set included all enrolled participants who received at least 1 dose of study medication.||participants|||Number
826325|NCT01189461|Primary|Incidence of Ocular and Non-Ocular Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Total number of participants who had ocular and non-ocular AEs was reported.|Baseline up to 30 days after last dose|Safety analysis set included all enrolled participants who received at least 1 dose of study medication. Same participant may be represented in more than 1 category.||participants|||Number
826326|NCT01189487|Secondary|Eradication Rate (Bacteriological Response, Investigator Assessment)|"Eradication Rate was calculated from the following formula, the number of participants assessed as eradication , presumed eradication or microbial substitution over total participants excluding ones assessed as indeterminate multiplied by 100. Microbial substitution means the appearance of new pathogens other than the original pathogens in a specimen from the same location with signs and symptoms of infection after the original pathogens were eradicated by treatment."|Day 4, End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure)|"Bacteriologic per protocol set consisted of all participants in the clinical per protocol set in whom bacterial pathogens were identified at baseline. No imputation was used for missing data. n in the Measure Values was the total participants EXCLUDING ones assessed as indeterminate."||percentageof participants||95% Confidence Interval|Number
826327|NCT01189487|Secondary|Eradication Rate (Bacteriological Response, Data Review Committee Assessment)|"Eradication Rate was calculated from the following formula, the number of participants assessed as eradication, presumed eradication or microbial substitution over total participants excluding ones assessed as indeterminate multiplied by 100. Microbial substitution means the appearance of new pathogens other than the original pathogens in a specimen from the same location with signs and symptoms of infection after the original pathogens were eradicated by treatment."|Day 4, End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure)|"Bacteriologic per protocol set consisted of all participants in the clinical per protocol set in whom bacterial pathogens were identified at baseline. No imputation was used for missing data. n in the Measure Values was the total participants EXCLUDING ones assessed as indeterminate."||percentage of participants||95% Confidence Interval|Number
826328|NCT01189487|Secondary|The Tendency Toward Clinical Improvement (Investigator Assessment)|The number of participants who showed tendency toward clinical improvement based on the assessment of temperature, white blood cell count, C-reactive protein, clinical symptoms on Day 4 and was determined to continue the treatment.|Day 4|Clinical per protocol set consisted of all participants who received at least one dose, have no significant violation of protocol, and underwent prescribed evaluations during the observation period. No imputation was used for missing data.||percentage of participants|||Number
826329|NCT01189487|Secondary|Response Rate (Clinical Response, Investigator Assessment)|"Response rate was calculated from the following formula, the number of participants assessed as effective over total participants EXCLUDING ones assessed as indeterminate multiplied by 100."|End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure)|"Clinical per protocol set consisted of all participants who received at least one dose, have no significant violation of protocol, and underwent prescribed evaluations during the observation period. No imputation was used for missing data. n in the Measure Values means total participants excluding ones assessed as indeterminate."||percentage of participants||95% Confidence Interval|Number
826330|NCT01189487|Primary|Response Rate (Clinical Response, Data Review Committee Assessment)|"Response rate was calculated from the following formula, the number of participants assessed as effective over total participants excluding ones assessed as indeterminate multiplied by 100."|End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure)|"Clinical per protocol set consisted of all participants who received at least one dose, have no significant violation of protocol, and underwent prescribed evaluations during the observation period. No imputation was used for missing data. n in the Measure Values means total participants EXCLUDING ones assessed as indeterminate."||percentage of participants||95% Confidence Interval|Number
826343|NCT01189500|Secondary|N-desmethyl-tamoxifen (Metabolite) Terminal Half-life (t 1/2) Following Tamoxifen Alone and When Coadministered With DVS SR|Terminal half-life is the time measured for the plasma concentration to decrease by one half.|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. N=number of participants contributing to the mean.||hours||Standard Error|Mean
826331|NCT01189500|Secondary|Plasma 4-hydroxy-tamoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR|Summary statistics were to be calculated by setting concentration values below the lower limit of quantification (LLQ = 0.100 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) = 0.|Period 1 / Day 1 and Period 2 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing|PK concentration analysis population. N=number of participants contributing to the median. Period 2 / Day 1 = Day 1 of Tamoxifen dosing (Period 2 / Day 7) within the DVS SR, Tamoxifen coadministration dosing period.||ng/mL||Full Range|Median
826332|NCT01189500|Secondary|Plasma N-desmethyl-tamoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR|Summary statistics were to be calculated by setting concentration values below the lower limit of quantification (LLQ = 0.250 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) = 0.|Period 1 / Day 1 and Period 2 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing|PK concentration analysis population. N=number of participants contributing to the median. Period 2 / Day 1 = Day 1 of Tamoxifen dosing (Period 2 / Day 7) within the DVS SR, Tamoxifen coadministration dosing period.||ng/mL||Full Range|Median
826333|NCT01189500|Secondary|Plasma Endoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR|Summary statistics were to be calculated by setting concentration values below the lower limit of quantification (LLQ = 0.100 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) = 0.|Period 1 / Day 1 and Period 2 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing|PK concentration analysis population. N=number of participants contributing to the median. Period 2 / Day 1 = Day 1 of Tamoxifen dosing (Period 2 / Day 7) within the DVS SR, Tamoxifen coadministration dosing period.||ng/mL||Full Range|Median
826334|NCT01189500|Secondary|Plasma Tamoxifen Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR|Summary statistics were to be calculated by setting concentration values below the lower limit of quantification (LLQ = 0.250 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) = 0.|Period 1 / Day 1 and Period 2 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing|PK concentration analysis population: all participants randomized and treated who had at least 1 concentration in at least 1 treatment period. N=number of participants contributing to the median. Period 2 / Day 1 = Day 1 of Tamoxifen dosing (Period 2 / Day 7) within the DVS SR, Tamoxifen coadministration dosing period.||ng/mL||Full Range|Median
826335|NCT01189500|Secondary|4-hydroxy-tamoxifen (Metabolite) Apparent Volume of Distribution (Vz/F) Following Tamoxifen Alone and When Coadministered With DVS SR||Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. Data was insufficient for analysis; not analyzable.||liters||Standard Deviation|Geometric Mean
826336|NCT01189500|Secondary|4-hydroxy-tamoxifen (Metabolite) Apparent Clearance (CL/F) Following Tamoxifen Alone and When Coadministered With DVS SR|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood calculated as (Dose/AUCinf); measured as milliliters per minute (mL/min).|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. Data was insufficient for analysis; not analyzable.||mL/min||Standard Deviation|Geometric Mean
826337|NCT01189500|Secondary|4-hydroxy-tamoxifen (Metabolite) Terminal Half-life (t 1/2) Following Tamoxifen Alone and When Coadministered With DVS SR|Terminal half-life is the time measured for the plasma concentration to decrease by one half.|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. N=number of participants contributing to the mean.||hours||Standard Error|Mean
826338|NCT01189500|Secondary|4-hydroxy-tamoxifen (Metabolite) Time for Cmax (Tmax) Following Tamoxifen Alone and When Coadministered With DVS SR|Time for maximum observed plasma concentration.|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. N=number of participants contributing to the median.||hours||Full Range|Median
826339|NCT01189500|Secondary|4-hydroxy-tamoxifen (Metabolite) Maximum Observed Concentration (Cmax) Following Tamoxifen Alone and When Coadministered With DVS SR||Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. N=number of participants contributing to the mean.||ng/mL||Standard Deviation|Geometric Mean
826340|NCT01189500|Secondary|4-hydroxy-tamoxifen (Metabolite) Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Tamoxifen Alone and When Coadministered With DVS SR|4-hydroxy-tamoxifen is a metabolite of Tamoxifen. Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. N=number of participants contributing to the mean.||ng*hr/mL||Standard Deviation|Geometric Mean
826341|NCT01189500|Secondary|N-desmethyl-tamoxifen (Metabolite) Apparent Volume of Distribution (Vz/F) Following Tamoxifen Alone and When Coadministered With DVS SR||Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. Data was insufficient for analysis; not analyzable.||liters||Standard Deviation|Geometric Mean
826345|NCT01189500|Secondary|N-desmethyl-tamoxifen (Metabolite) Maximum Observed Concentration (Cmax) Following Tamoxifen Alone and When Coadministered With DVS SR||Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. N=number of participants contributing to the mean.||ng/mL||Standard Deviation|Geometric Mean
826346|NCT01189500|Secondary|N-desmethyl-tamoxifen (Metabolite) Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Tamoxifen Alone and When Coadministered With DVS SR|N-desmethyl-tamoxifen is a metabolite of Tamoxifen. Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. N=number of participants contributing to the mean.||ng*hr/mL||Standard Deviation|Geometric Mean
826347|NCT01189500|Secondary|Endoxifen (Metabolite) Apparent Volume of Distribution (Vz/F) Following Tamoxifen Alone and When Coadministered With DVS SR||Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. Data was insufficient for analysis; not analyzable.||liters||Standard Deviation|Geometric Mean
826348|NCT01189500|Secondary|Endoxifen (Metabolite) Apparent Clearance (CL/F) Following Tamoxifen Alone and When Coadministered With DVS SR|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood calculated as (Dose/AUCinf); measured as milliliters per minute (mL/min).|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. Data was insufficient for analysis; not analyzable.||mL/min||Standard Deviation|Geometric Mean
826349|NCT01189500|Secondary|Endoxifen (Metabolite) Terminal Half-life (t 1/2) Following Tamoxifen Alone and When Coadministered With DVS SR|Terminal half-life is the time measured for the plasma concentration to decrease by one half.|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. N=number of participants contributing to the mean.||hours||Standard Deviation|Mean
826350|NCT01189500|Secondary|Endoxifen (Metabolite) Time for Cmax (Tmax) Following Tamoxifen Alone and When Coadministered With DVS SR|Time for maximum observed plasma concentration.|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. N=number of participants contributing to the median.||hours||Full Range|Median
826351|NCT01189500|Secondary|Endoxifen (Metabolite) Maximum Observed Concentration (Cmax) Following Tamoxifen Alone and When Coadministered With DVS SR||Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. N=number of participants contributing to the mean.||ng/mL||Standard Deviation|Geometric Mean
826352|NCT01189500|Secondary|Tamoxifen Apparent Volume of Distribution (Vz/F) Following Tamoxifen Alone and When Coadministered With DVS SR|Calculated as Dose / (AUCinf * kel); where kel=terminal phase rate constant.|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. N=number of participants contributing to the mean.||liters||Standard Deviation|Geometric Mean
826353|NCT01189500|Secondary|Tamoxifen Apparent Clearance (CL/F) Following Tamoxifen Alone and When Coadministered With DVS SR|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood calculated as (Dose/AUCinf); measured as milliliters per minute (mL/min).|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. N=number of participants contributing to the mean.||mL/min||Standard Deviation|Geometric Mean
826354|NCT01189500|Secondary|Tamoxifen Terminal Half-life (t 1/2) Following Tamoxifen Alone and When Coadministered With DVS SR|Terminal half-life is the time measured for the plasma concentration to decrease by one half.|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. N=number of participants contributing to the mean.||hours||Standard Deviation|Mean
826355|NCT01189500|Secondary|Tamoxifen Time for Cmax (Tmax) Following Tamoxifen Alone and When Coadministered With DVS SR|Time for maximum observed plasma concentration.|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. N=number of participants contributing to the median.||hours||Full Range|Median
826356|NCT01189500|Secondary|Tamoxifen Maximum Observed Concentration (Cmax) Following Tamoxifen Alone and When Coadministered With DVS SR|Cmax measured as nanograms per milliliters (ng/mL).|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. N=number of participants contributing to the mean.||ng/mL||Standard Deviation|Geometric Mean
826429|NCT01190124|Secondary|HIV-RNA Levels|For patients in whom T20 was replaced by raltegravir it will be determined the number of patients that maintain undetectable viral load (confirmed HIV RNA < 50 copies/mL) at week 48.|Week 48|||participants|||Number
826357|NCT01189500|Primary|Endoxifen (Metabolite) Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Endoxifen Alone and When Coadministered With DVS SR|Endoxifen is a metabolite of Tamoxifen. Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. N=number of participants contributing to the mean.||ng*hr/mL||Standard Deviation|Geometric Mean
826358|NCT01189500|Primary|Tamoxifen Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Tamoxifen Alone and When Coadministered With DVS SR|Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞); measured as nanograms multiplied by hours divided by milliliters (ng*hr/mL).|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|Pharmacokinetic (PK) parameter analysis population: all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. N=number of participants contributing to the mean.||ng*hr/mL||Standard Deviation|Geometric Mean
826359|NCT01189604|Secondary|Modified Observers Assessment of Alertness/Sedation (MOAA/S) at End of Initiation Period|The MOAA/S is a 6-point ordinal scale measuring a patient's level of sedation. Scores range from 0 (No response to painful stimulus [trapezius squeeze]) to 5 (Responds readily to name spoken in normal tone [awake]). MOAA/S scores were classified as 0-1, 2-4 and 5.|Last measurement in maintenance period (3 minutes for arms 1-5; 1 minute for arm 6, 5 minute for arm 7)|||Participants|||Number
826360|NCT01189604|Secondary|Blood Concentrations of Propofol|Blood concentration of ICI35,868 (propofol)|At the end of the initiation period and every 2 minutes during the maintenance period|||µg/mL||Standard Deviation|Mean
826361|NCT01189604|Secondary|Patient Satisfaction With Sedation Instrument (PSSI) Questionnaire|The PSSI is a 100-point visual analog scale measuring a patient's satisfaction with sedation. Scores range from 0 (Very dissatisfied) to 100 (Very satisfied).|24 - 48 hours after completion of the procedure|||Units on a scale||Standard Deviation|Mean
826362|NCT01189604|Primary|Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 4 Minutes From Beginning of Maintenance Period|The MOAA/S is a 6-point ordinal scale measuring a patient's level of sedation. Scores range from 0 (No response to painful stimulus [trapezius squeeze]) to 5 (Responds readily to name spoken in normal tone [awake]). MOAA/S scores were classified as 0-1, 2-4 and 5.|4 minutes from the beginning of the maintenance period|||Participants|||Number
826363|NCT01189604|Primary|Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 2 Minutes From Beginning of Maintenance Period|The MOAA/S is a 6-point ordinal scale measuring a patient's level of sedation. Scores range from 0 (No response to painful stimulus [trapezius squeeze]) to 5 (Responds readily to name spoken in normal tone [awake]). MOAA/S scores were classified as 0-1, 2-4 and 5.|2 minutes from the beginning of the maintenance period|||Participants|||Number
826364|NCT01189617|Primary|"Number of Subjects With Irritation Score of 0 at Baseline and One Week"|Severity of irritation on a scale from 0 (No Irritation) to 6 (Presence of Lesions). Since a score of 0 is required at baseline for inclusion in the trial, this score represents a change from baseline and the trial is considered baseline-controlled.|Baseline and One Week|Full Analysis Set||Participants|||Number
826365|NCT01189747|Secondary|Percentage of Participants With a ≥ 3-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 8 at Day 30|The percentage of FLO-11 Item #8 responders, defined as participants with a ≥ 3-point improvement in FLO-11 score from baseline for FLO-11 Question #8: “My facial lines make me look tired” The FLO-11 questionnaire is comprised of 11 items that assess the subject's perceptions about specific aspects of their facial lines for the previous 7 days. Each question is scored on an 11-point scale (0=not at all, 5=somewhat, 10=very much).|Baseline, Day 30|Intent-to-treat population consisted of all randomized participants. Only subjects with Baseline scores ≥ 3 were included.||Percentage of participants|||Number
826366|NCT01189747|Secondary|Percentage of Participants With a ≥ 2-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 5 at Day 30|The percentage of FLO-11 Item #5 responders, defined as participants with a ≥ 2-point improvement in FLO-11 score from Baseline for FLO-11 Question #5: “My facial lines make me look less attractive than I want to look.” The FLO-11 questionnaire is comprised of 11 items that assess the subject's perceptions about specific aspects of their facial lines for the previous 7 days. Each question is scored on an 11-point scale (0=not at all, 5=somewhat, 10=very much).|Baseline, Day 30|Intent-to-treat population consisted of all randomized participants. Only subjects with Baseline scores ≥ 2 were included.||Percentage of participants|||Number
826367|NCT01189747|Secondary|Percentage of Participants With a ≥ 2-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 2 at Day 30|The percentage of FLO-11 Item #2 responders, defined as participants with a ≥ 2-point improvement in FLO-11 score from Baseline for FLO-11 Question #2: “When I look in the mirror, my facial lines make me look older than I want to look.” The FLO-11 questionnaire is comprised of 11 items that assess the subject's perceptions about specific aspects of their facial lines for the previous 7 days. Each question is scored on an 11-point scale (0=not at all, 5=somewhat, 10=very much).|Baseline, Day 30|Intent-to-treat population consisted of all randomized participants. Only subjects with Baseline scores ≥ 2 were included.||Percentage of participants|||Number
826368|NCT01189747|Secondary|Percentage of Participants Who Judged Themselves in a Younger Self-Perception of Age Category Than at Baseline|Participants were considered to judge themselves younger if the category change was from “look my current age” at Baseline to “look younger” at Day 30 or from “look older” at Baseline to “look my current age/younger” at Day 30.|Baseline, Day 30|"Intent-to-treat population included all randomized participants. Only those participants who rated themselves as look my current age or look older at Baseline are included in the analyses."||Percentage of participants|||Number
826430|NCT01190124|Secondary|HIV-RNA Levels|For patients in whom T20 was replaced by raltegravir it will be determined the number of patients that maintain undetectable viral load (confirmed HIV RNA < 50 copies/mL) at week 24.|Week 24|||participants|||Number
826369|NCT01189747|Secondary|Subject Global Assessment of Change in Crow’s Feet Lines (SGA-CFL) Score|Patients rated the change in their Crow’s Feet Lines using the SGA-CFL 7-point scale: 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse or 7=very much worse at Day 30. Lower scores indicate improvement.|Day 30|Intent-to-treat population included all randomized participants.||Score on a scale||Standard Deviation|Mean
826370|NCT01189747|Secondary|Percentage of Participants With a ≥ 1-Grade Improvement From Baseline by Investigator Facial Wrinkle Scale Assessment of the Severity of Crow’s Feet Lines at Rest|The Investigator assessed the severity of the patient's Crow's Feet Lines at rest using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a ≥ 1-grade improvement from Baseline at Day 30 is reported.|Baseline, Day 30|Intent-to-treat participants included all randomized participants. Only participants who were rated at least mild at Baseline are included in the analyses.||Percentage of participants|||Number
826371|NCT01189747|Secondary|Percentage of Participants With a ≥ 1-Grade Improvement From Baseline by Investigator Facial Wrinkle Scale Assessment of the Severity of Crow’s Feet Lines at Maximum Smile|The Investigator assessed the severity of the patient's Crow's Feet Lines at maximum smile using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a ≥ 1-grade improvement from Baseline at Day 30 is reported.|Baseline, Day 30|Intent-to-treat population included all randomized participants.||Percentage of participants|||Number
826372|NCT01189747|Secondary|Percentage of Participants Achieving a Grade of None or Mild at Maximum Smile Based on the Investigator’s Facial Wrinkle Scale Assessment of the Severity of Crow’s Feet Lines|The Investigator assessed the severity of the patient's Crow's Feet lines at maximum smile using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30 is reported.|Day 30|Intent-to-treat population included all randomized participants.||Percentage of participants|||Number
826373|NCT01189747|Primary|Percentage of Responders Based on Composite Facial Wrinkle Scale Assessment of Crow's Feet Line Severity at Maximum Smile|The composite facial wrinkle scale assessment is based on both the Investigator and Subject Facial Wrinkle scales at Day 30. The Investigator assessed the severity of the patient's Crow's Feet Lines at maximum smile using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe and the patient assessed the severity of their Crow's Feet Lines at maximum smile using the same 4-point Facial Wrinkle Scale. A responder is defined as a participant with a ≥ 2-grade improvement from Baseline.|Baseline, Day 30|Intent-to-treat population included all randomized participants. Participants with missing values are considered non-responders.||Percentage of participants|||Number
826374|NCT01189760|Secondary|Percentage of Participants With a ≥ 3-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 8 at Day 30|The percentage of FLO-11 Item #8 responders, defined as participants with a ≥ 3-point improvement in FLO-11 score from Baseline for FLO-11 Question #8: “My facial lines make me look tired.” The FLO-11 questionnaire is comprised of 11 items that assess the subject's perceptions about specific aspects of their facial lines for the previous 7 days. Each question is scored on an 11-point scale (0=not at all, 5=somewhat, 10=very much).|Baseline, Day 30|Intent-to-treat population included all randomized participants. Only participants with a Baseline score ≥ 3 are included.||Percentage of participants|||Number
826375|NCT01189760|Secondary|Percentage of Participants With a ≥ 2-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 5 at Day 30|The percentage of FLO-11 Item #5 responders, defined as participants with a ≥ 2-point improvement in FLO-11 score from Baseline for FLO-11 Question #5: “My facial lines make me look less attractive than I want to look.” The FLO-11 questionnaire is comprised of 11 items that assess the subject's perceptions about specific aspects of their facial lines for the previous 7 days. Each question is scored on an 11-point scale (0=not at all, 5=somewhat, 10=very much).|Baseline, Day 30|Intent-to-treat population included all randomized participants. Only participants with a Baseline score ≥ 2 are included.||Percentage of participants|||Number
826376|NCT01189760|Secondary|Percentage of Participants With a ≥ 2-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 2 at Day 30|The percentage of FLO-11 Item #2 responders, defined as participants with a ≥ 2-point improvement in FLO-11 score from Baseline for FLO-11 Question #2: “When I look in the mirror, my facial lines make me look older than I want to look.” The FLO-11 questionnaire is comprised of 11 items that assess the subject's perceptions about specific aspects of their facial lines for the previous 7 days. Each question is scored on an 11-point scale (0=not at all, 5=somewhat, 10=very much).|Baseline, Day 30|Intent-to-treat population included all randomized participants. Only participants with a Baseline score ≥ 2 are included.||Percentage of participants|||Number
826377|NCT01189760|Secondary|Percentage of Participants Who Judged Themselves in a Younger Self-Perception of Age Category Than at Baseline|Participants were considered to judge themselves as looking younger if the category change was from “look my current age” at Baseline to “look younger” at Day 30 or from “look older” at Baseline to “look my current age/younger” at Day 30.|Baseline, Day 30|"Intent-to-treat population included all randomized participants. Only those participants who rated themselves as look my current age or look older at Baseline are included in the analyses."||Percentage of participants|||Number
826378|NCT01189760|Secondary|Subject Global Assessment of Change in Crow’s Feet Lines (SGA-CFL) Score|Patients rated the change in their Crow’s Feet Lines using the SGA-CFL 7-point scale: 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse or 7=very much worse at Day 30. Lower scores indicate improvement.|Day 30|Intent-to-treat population included all randomized participants.||Score on a scale||Standard Deviation|Mean
826379|NCT01189760|Secondary|Percentage of Participants With a ≥ 1-Grade Improvement From Baseline by Investigator Facial Wrinkle Scale Assessment of the Severity of Crow’s Feet Lines at Rest|The Investigator assessed the severity of the patient's Crow's Feet Lines at rest using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a ≥ 1-grade improvement from Baseline at Day 30 is reported.|Baseline, Day 30|Intent-to-treat population included all randomized participants. Only those participants who were rated at least mild at Baseline are included in the analyses.||Percentage of participants|||Number
826431|NCT01190124|Secondary|HIV-RNA Levels|For patients in whom T20 was replaced by raltegravir it will be determined the number of patients that presented undetectable viral load (confirmed HIV RNA < 50 copies/mL) at baseline.|Baseline|||participants|||Number
826380|NCT01189760|Secondary|Percentage of Participants With a ≥ 1-Grade Improvement From Baseline by Investigator Facial Wrinkle Scale Assessment of the Severity of Crow’s Feet Lines at Maximum Smile|The Investigator assessed the severity of the patient's Crow's Feet Lines at maximum smile using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a ≥ 1-grade improvement from Baseline at Day 30 is reported.|Baseline, Day 30|Intent-to-treat population included all randomized participants.||Percentage of participants|||Number
826381|NCT01189760|Secondary|Percentage of Participants Achieving a Grade of None or Mild at Maximum Smile Based on the Investigator Facial Wrinkle Scale Assessment of the Severity of Crow’s Feet Lines|The Investigator assessed the severity of the patient's Crow's Feet lines at maximum smile using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30 is reported.|Day 30|Intent-to-treat population included all randomized participants.||Percentage of participants|||Number
826382|NCT01189760|Primary|Percentage of Responders Based on Composite Facial Wrinkle Scale Assessment of Crow's Feet Line Severity at Maximum Smile|The composite facial wrinkle scale assessment is based on both the Investigator and Subject Facial Wrinkle scales at Day 30. The Investigator assessed the severity of the patient's Crow's Feet Lines at maximum smile using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe and the patient assessed the severity of their Crow's Feet Lines at maximum smile using the same 4-point Facial Wrinkle Scale. A responder is defined as a participant with a ≥ 2-grade improvement from Baseline.|Baseline, Day 30|Intent-to-treat population included all randomized participants. Participants with missing values are considered non-responders.||Percentage of participants|||Number
826383|NCT01189812|Secondary|Beck Scale for Suicide Ideation (BSS)|"The BSS is a 21-item slef-report instrument used to detect ans measure the severity of suicidal ideation in adults. It measures a broad spectrum of attitudes and behaviors for assessing patient suicide risk, as well as reveals specific suicidal characteristics which require greater scrutiny.
Comparison between citalopram and lithium and citalopram and placebo groups in the BSS will be made from baseline to week 4"|4 weeks||||||
826384|NCT01189812|Secondary|Beck Hopelessness Scale (BHS)|"The BHS measures the extent of negative attitudes about the future. It has particular utility as an indirect indicator of suicidal risk in depressed examinees or individuals who have made suicide attempts.
Comparison between citalopram and lithium and citalopram and placebo groups in the BHS will be made from baseline to week 4"|4 weeks||||||
826385|NCT01189812|Primary|Sheehan-Suicidality Tracking Scale (S-STS)|"The S-STS is an 14 item clinician administered prospective rating scale that scores both treatment-emergent suicidal ideations and suicidal behaviors with scores ranging from 0-40 points. Patients scoring a 0 are experiencing no suicidal thoughts, ideations, or attempts, while a score of 40 indicates a fatal, completed suicide.
Comparison was made between the citalopram with lithium and the citalopram with placebo treatment groups. Outcome measures are expressed as change scores from the baseline visit to week 4."|4 weeks; from Baseline to Week 4|The ITT population consisted of 80 patients randomized to lithium (n=40)or placebo (n=40).||Scores on a Scale (S-STSS)|Participants|Standard Deviation|Mean
826386|NCT01189890|Secondary|LS Mean Change From Baseline in Participant Body Weight at Week 30|Participants were only permitted to wear a drape gown and undergarments (no street clothes, no shoes or socks) for this evaluation. Body weight was measured after voiding (to the nearest 0.1 kg) and measurements were collected until 2 consecutive measurements did not differ by more than 0.2 kg from each other. Body weight measurements were evaluated using a standardized, calibrated digital scale and was reported in kilograms (kg) at baseline and Week 30.|Baseline and Week 30|All randomized participants who received at least one dose of study treatment and had body weight measurements at baseline and at Week 30.||kg||95% Confidence Interval|Least Squares Mean
826387|NCT01189890|Secondary|Percentage of Participants With HbA1c <6.5% at Week 30|Participant whole blood samples were collected at Week 30 to determine the number of participants achieving HbA1c <6.5% at Week 30. Hemoglobin A1c is a measure of the percentage of glycated hemoglobin in the blood and provides an indication of participant blood glucose control in the 2 to 3 months prior to the evaluation.|Week 30|The population included all randomized participants who had HbA1c at baseline and Week 30, did not take prohibited concomitant medications, had compliance >85%, and did not receive any incorrect study medication.||Percentage of Participants|||Number
826388|NCT01189890|Secondary|Percentage of Participants With HbA1c <7.0% at Week 30|Participant whole blood samples were collected at Week 30 to determine the number of participants achieving HbA1c <7.0% at Week 30. HbA1c is a measure of the percentage of glycated hemoglobin in the blood and provides an indication of participant blood glucose control in the 2 to 3 months prior to the evaluation.|Week 30|The population included all randomized participants who had HbA1c at baseline and Week 30, did not take prohibited concomitant medications, had compliance >85%, and did not receive any incorrect study medication.||Percentage of Participants|||Number
826389|NCT01189890|Secondary|LS Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 30|Plasma samples were collected from participants after an overnight fast at baseline and Week 30 to determine the mean change from baseline in participant FPG.|Baseline and Week 30|The population included all randomized participants who had a FPG value at baseline and Week 30, did not take prohibited concomitant medications, had compliance >85%, and did not receive any incorrect study medication.||mg/dL||95% Confidence Interval|Least Squares Mean
826390|NCT01189890|Primary|Number of Participants Discontinuing Study Treatment Due to An AE|"An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the
study treatment, whether or not considered related to the use of the treatment administered."|Up to Week 30|All randomized participants who received at least one dose of study treatment.||Participants|||Number
826391|NCT01189890|Primary|Number of Participants Experiencing An Adverse Event (AE)|"An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the
study treatment, whether or not considered related to the use of the treatment administered."|Up to Week 30|All randomized participants who received at least one dose of study treatment.||Participants|||Number
826432|NCT01190124|Primary|CD4 Cells Count|CD4 cells count at baseline.|Baseline|||cells/mm^3||Full Range|Median
826433|NCT01190124|Primary|HIV-RNA Levels|Patients achieving undetectable viral load (confirmed HIV RNA < 50 copies/mL) at week 48.|week 48|||participants|||Number
826392|NCT01189890|Primary|Number of Participants With an Adverse Event of Symptomatic Hypoglycemia Up to Week 30|Symptomatic hypoglycemia was defined as an episode with clinical symptoms attributed to hypoglycemia, without regard to glucose level. Participants were instructed to complete the Hypoglycemia Assessment Log (HAL) for any symptomatic episodes he or she believed represent hypoglycemia. If a fingerstick glucose was obtained before or shortly (i.e., within a few minutes) after treating, the value was recorded in the HAL. In addition, participants were instructed to record in the HAL any fingerstick glucose values ≤70 mg/dL (≤3.9 mmol/L) regardless of the presence of clinical symptoms.|Up to Week 30|All randomized participants who received at least one dose of study treatment.||Participants|||Number
826393|NCT01189890|Primary|Least Squares (LS) Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 30|Participant whole blood samples were collected at baseline and Week 30 to determine the LS mean HbA1c change from baseline. HbA1c is a measure of the percentage of glycated hemoglobin in the blood and provides an indication of participant blood glucose control in the 2 to 3 months prior to the evaluation.|Baseline and Week 30|The population included all randomized participants who had a baseline HbA1c, had a HbA1c at Week 30, did not take prohibited concomitant medications, had compliance >85%, and did not receive any incorrect study medication.||Percentage of HbA1c||95% Confidence Interval|Least Squares Mean
826394|NCT01190007|Secondary|Percent Change From Baseline in Apolipoprotein B at Each Visit|"Value at each visits minus value at baseline divided by value at baseline multiplied by 100"|Week 4, 12, 24, and 52|The efficacy analysis set included all participants who took at least one dose of study drug and contributed data to baseline and at least one post-baseline efficacy assessment. LOCF means Last Observation Carried Forward.||Percentage of Apolipoprotein B||Standard Deviation|Mean
826395|NCT01190007|Secondary|Change From Baseline in Ratio of Total Cholesterol (TC) to High Density Lipoprotein Cholesterol (HDL-C) at Each Visit|Value at each visits minus value at baseline|Weeks 4, 12, 24, and 52|The efficacy analysis set included all participants who took at least one dose of study drug and contributed data to baseline and at least one post-baseline efficacy assessment. LOCF means Last Observation Carried Forward.||Ratio||Standard Deviation|Mean
826396|NCT01190007|Secondary|Change From Baseline in Ratio of Low Density Lipoprotein Cholesterol (LDL-C) to High Density Lipoprotein Cholesterol (HDL-C) at Each Visit|Value at each visits minus value at baseline|Weeks 4, 12, 24, and 52|The efficacy analysis set included all participants who took at least one dose of study drug and contributed data to baseline and at least one post-baseline efficacy assessment. LOCF means Last Observation Carried Forward.||Ratio||Standard Deviation|Mean
826397|NCT01190007|Secondary|Percent Change From Baseline in Triglyceride (TG) at Each Visit|"Value at each visits minus value at baseline divided by value at baseline multiplied by 100"|Week 4, 12, 24, and 52|The efficacy analysis set included all participants who took at least one dose of study drug and contributed data to baseline and at least one post-baseline efficacy assessment. LOCF means Last Observation Carried Forward.||Percentage of TG||Standard Deviation|Mean
826398|NCT01190007|Secondary|Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Each Visit|"Value at each visits minus value at baseline divided by value at baseline multiplied by 100"|Weeks 4, 12, 24, and 52|The efficacy analysis set included all participants who took at least one dose of study drug and contributed data to baseline and at least one post-baseline efficacy assessment. LOCF means Last Observation Carried Forward.||Percentage of HDL-C||Standard Deviation|Mean
826399|NCT01190007|Secondary|Percent Change From Baseline in Total Cholesterol (TC) at Each Visit|"Value at each visits minus value at baseline divided by value at baseline multiplied by 100"|Weeks 4, 12, 24, and 52|The efficacy analysis set included all participants who took at least one dose of study drug and contributed data to baseline and at least one post-baseline efficacy assessment. LOCF means Last Observation Carried Forward.||Percentage of TC||Standard Deviation|Mean
826400|NCT01190007|Secondary|Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Each Visit|"Value at each visits minus value at baseline divided by value at baseline multiplied by 100"|Weeks 4, 12, 24, and 52|The efficacy analysis set included all participants who took at least one dose of study drug and contributed data to baseline and at least one post-baseline efficacy assessment. LOCF means Last Observation Carried Forward.||Percentage of LDL-C||Standard Deviation|Mean
826401|NCT01190007|Secondary|Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Angina Pectoris and Hypercholesterolemia|Value at each visits minus value at baseline|Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|"The efficacy analysis set included all participants who took at least one dose of study drug and contributed data to baseline and at least one post-baseline efficacy assessment.
Participants with both angina pectoris and hypercholesterolemia were included the participants with all of angina pectoris, hypertension and hypercholesterolemia."||mmHg||Standard Deviation|Mean
826402|NCT01190007|Secondary|Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia|Value at each visits minus value at baseline|Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|The efficacy analysis set included all participants who took at least one dose of study drug and contributed data to baseline and at least one post-baseline efficacy assessment. LOCF means Last Observation Carried Forward.||mmHg||Standard Deviation|Mean
826403|NCT01190007|Secondary|Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Population With Both Angina Pectoris and Hypercholesterolemia|Value at each visits minus value at baseline|Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|The efficacy analysis set included all participants who took at least one dose of study drug and contributed data to baseline and at least one post-baseline efficacy assessment. Participants both angina pectoris and hypercholesterolemia were included the participants with all of angina pectoris, hypertension and hypercholesterolemia.||mmHg||Standard Deviation|Mean
826404|NCT01190007|Secondary|Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia|Value at each visits minus value at baseline|Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|The efficacy analysis set included all participants who took at least one dose of study drug and contributed data to baseline and at least one post-baseline efficacy assessment. LOCF means Last Observation Carried Forward.||mmHg||Standard Deviation|Mean
826434|NCT01190124|Primary|HIV-RNA Levels|Patients achieving undetectable viral load (confirmed HIV RNA < 50 copies/mL) at week 24.|week 24|||participants|||Number
826405|NCT01190007|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to [study drug] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.|52 weeks|The safety analysis set included all participants who took at least one dose of study drug.||Participants|||Number
826406|NCT01190085|Primary|Salivation|Whether ghrelin intravenous (i.v.), as compared to saline i.v., dose-dependently results in increased cue-reactivity (CR) responses to alcohol cues in terms of psychophysiological responses, namely salivation changes.|approximately 30 minutes after drug administration|||gram||Standard Deviation|Mean
826407|NCT01190085|Primary|Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability.|Whether ghrelin intravenous (i.v.), as compared to saline i.v., does not significantly increase Adverse Events (AEs).|participants will be followed after the cue-reactivity experiment, an expected average of 7 days|||participants|||Number
826408|NCT01190085|Primary|Alcohol Visual Analogue Scale (A-VAS)|"Whether ghrelin intravenous (i.v.), as compared to saline i.v., dose-dependently results in increased cue-reactivity (CR) responses to alcohol cues in terms of urge to drink [as measured by the Alcohol Visual Analogue Scale (A-VAS)].
The A-VAS was rated on 11-point anchored Likert-type scales, where 0 is the minimum score (no craving) and 11 is the maximum score (highest craving intensity). The change in the A-VAS score (deltaA-VAS) was used to indicate decrease (-d) or increase (+d) in craving intensity."|approximately 30 minutes after drug administration|||units on a scale||Standard Deviation|Mean
826409|NCT01190098|Secondary|Change in Quality of Life in Epilepsy (QOLIE-31) From Baseline to Visit 4|Range 0 -10 where higher scores reflect better quality of life.|Baseline to visit 4 (approximately 1 - 2 months)|5 subjects did not complete enough questions on the tool for the total score to be calculated at both time points.||units on a scale||95% Confidence Interval|Mean
826410|NCT01190098|Secondary|Change in Daily Seizure Frequency From Baseline to Visit 4|Number of seizures per day.|Baseline to visit 4 (approximately 1 - 2 months)|2 subjects did not complete seizure diary at both time points.||number of seizures per day||Inter-Quartile Range|Median
826411|NCT01190098|Secondary|Change in Patient Health Questionnaire-9 (PHQ-9) From Baseline to Visit 4.|Range 0-27, where higher scores indicate more impairment (depressive symptoms)|Baseline to visit 4 (approximately 1 - 2 months)|5 subjects did not complete enough questions on the tool for the total score to be calculated at both time points.||units on a scale||95% Confidence Interval|Mean
826412|NCT01190098|Secondary|Change in Adverse Event Profile (AEP) From Baseline to Visit 4.|Range 19-76, where higher scores indicate more severe impairment (in terms of 19 common antiepileptic drug side effects.|Baseline to visit 4 (approximately 1 - 2 months)|3 subjects did not complete enough questions on the tool for the total score to be calculated at both time points.||units on a scale||95% Confidence Interval|Mean
826413|NCT01190098|Secondary|Change in Functional Outcomes of Sleep Questionnaire (FOSQ) From Baseline to Visit 4.|Range 0-20 where lower scores indicate more impairment (sleep related QOL).|Baseline to visit 4 (approximately 1 - 2 months)|5 subjects did not complete enough questions on the tool for the total score to be calculated at both time points.||units on a scale||95% Confidence Interval|Mean
826414|NCT01190098|Secondary|Change in Pittsburgh Sleep Quality Inventory (PSQI) From Baseline to Visit 4|Range 0-21, where higher scores more impairment (in terms of sleep quality).|Baseline to Visit 4 (approximately 1 - 2 months)|7 subjects did not complete enough questions on the tool for the total score to be calculated at both time points.||units on a scale||95% Confidence Interval|Mean
826415|NCT01190098|Secondary|Change in the Fatigue Severity Scale From Baseline to Visit 4.|Fatigue Severity Scale (FSS): Range 7- 63 where higher scores indicate more severe fatigue.|Baseline to Visit 4 (approximately 1 - 2 months)|6 subjects did not complete enough questions on the tool for the total score to be calculated at both time points.||units on a scale||95% Confidence Interval|Mean
826416|NCT01190098|Primary|Change in Epworth Sleepiness Scale Score From Baseline to Visit 4|Scale 0 - 24 Higher scores indicate more severe symptoms|Baseline and Visit 4 (approximately 1 - 2 months)|||Units on a scale||95% Confidence Interval|Mean
826417|NCT01190124|Secondary|Adverse Drug Reactions|Number of participants that suffered clinical and laboratory-associated adverse events, including events that lead to discontinuations or death. Investigator will collect all drug-related adverse events, i.e. judged by the investigator to be definitely, probably, or possibly related to the study drug.|Week 48|||participants|||Number
826418|NCT01190124|Primary|CD4 Cells Count|CD4 cells count at week 48.|week 48|||cells/mm^3||Full Range|Median
826419|NCT01190124|Primary|CD4 Cells Count|CD4 cells count at week 24.|week 24|||cells/mm^3||Full Range|Median
826420|NCT01190124|Secondary|HIV-RNA Levels|For the HIV-2 infected patients it will be determined the number of patients that achieve or maintain undetectable viral load (confirmed HIV RNA < 50 copies/mL) at week 48.|Week 48|||participants|||Number
826421|NCT01190124|Secondary|HIV-RNA Levels|For the HIV-2 infected patients it will be determined the number of patients that achieve or maintain undetectable viral load (confirmed HIV RNA < 50 copies/mL) at week 24.|Week 24|||participants|||Number
826422|NCT01190124|Secondary|HIV-RNA Levels|For the HIV-2 infected patients it will be determined the number of patients with undetectable viral load (confirmed HIV RNA < 50 copies/mL) at baseline.|Baseline|||participants|||Number
826423|NCT01190124|Secondary|CD4 Cells Count|For the HIV-2 infected patients CD4 cells count will be assessed at week 48.|Week 48|||cells/mm^3||Full Range|Median
826424|NCT01190124|Secondary|CD4 Cells Count|For the HIV-2 infected patients CD4 cells count will be assessed at week 24.|Week 24|||cells/mm^3||Full Range|Median
826425|NCT01190124|Secondary|CD4 Cells Count|For the HIV-2 infected patients CD4 cells count will be assessed at baseline.|Baseline|||cells/mm^3||Full Range|Median
826426|NCT01190124|Secondary|CD4 Cells Count|For patients in whom T20 was replaced by raltegravir it will be assessed the median changes of CD4 cells count at week 48.|Week 48|||cells/mm^3||Full Range|Median
826427|NCT01190124|Secondary|CD4 Cells Count|For patients in whom T20 was replaced by raltegravir it will be assessed the median changes of CD4 cells count at week 24.|Week 24|||cells/mm^3||Full Range|Median
826428|NCT01190124|Secondary|CD4 Cells Count|For patients in whom T20 was replaced by raltegravir CD4 cells count will be assessed.|Baseline|||cells/mm^3||Full Range|Median
826435|NCT01190124|Primary|HIV-RNA Levels|Patients with undetectable viral load (confirmed HIV RNA < 50 copies/mL) at baseline.|Baseline|||participants|||Number
826436|NCT01190150|Secondary|Participants With Treatment-emergent Adverse Events (TEAEs)|Treatment-emergent AEs are summarized by total participants with TEAEs, participants with serious TEAEs, participants with TEAEs deemed by the investigator to be related to treatment, and participants who experienced TEAEs that caused permanent discontinuation from the study.|Day 1 up to week 4|The Safety Population consisted of all randomized participants who received at least one dose of tranexamic acid.||participants|||Number
826437|NCT01190150|Primary|Elimination Half-life (t ½)|Apparent first-order terminal elimination half life|Day 1 or Day 8 (before dosing and at the following times thereafter: 0.5, 0.75, 1, 2, 2.5, 3.0, 3.5, 4, 5, 6, 10, 14, and 24 hours post-dose)|Plasma PK population includes all participants with at least one quantifiable PK concentration.||hours||Standard Deviation|Mean
826438|NCT01190150|Primary|The Ratio of AUC0-t to AUCinf|Comparison of AUC0-t to AUCinf by creating a ratio.|Day 1 or Day 8 (before dosing and at the following times thereafter: 0.5, 0.75, 1, 2, 2.5, 3.0, 3.5, 4, 5, 6, 10, 14, and 24 hours post-dose)|Plasma PK population including all participants with three or more non-zero plasma concentrations. One participant withdrew on Day 7 and did not meet the requisite samples required for this PK parameter.||ratio of AUC0-t / AUCinf||Standard Deviation|Mean
826439|NCT01190150|Primary|Dose Normalized Area Under the Concentration Versus Time Curve From 0 to Infinity (AUCinf)|Dose-normalized AUCinf is calculated as the sum of AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant, normalized to the 1.3 g dose.|Day 1 or Day 8 (before dosing and at the following times thereafter: 0.5, 0.75, 1, 2, 2.5, 3.0, 3.5, 4, 5, 6, 10, 14, and 24 hours post-dose)|Plasma PK population including all participants with three or more non-zero plasma concentrations. One participant withdrew on Day 7 and did not meet the requisite samples required for this PK parameter.||μg*h/mL||Standard Deviation|Mean
826440|NCT01190150|Primary|Area Under the Concentration Versus Time Curve From 0 to Infinity (AUCinf)|The area under the plasma concentration versus time curve from time 0 to infinity. AUCinf is calculated as the sum of AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant.|Day 1 or Day 8 (before dosing and at the following times thereafter: 0.5, 0.75, 1, 2, 2.5, 3.0, 3.5, 4, 5, 6, 10, 14, and 24 hours post-dose)|Plasma PK population including all participants with three or more non-zero plasma concentrations. One participant withdrew on Day 7 and did not meet the requisite samples required for this PK parameter.||μg*h/mL||Standard Deviation|Mean
826441|NCT01190150|Primary|Dose Normalized Area Under the Concentration Versus Time Curve From 0 to the Last Time Point (AUC0-t)|The area under the plasma concentration versus time curve, from time 0 to the last measurable concentration normalized to the 1.3 g dose.|Day 1 or Day 8 (before dosing and at the following times thereafter: 0.5, 0.75, 1, 2, 2.5, 3.0, 3.5, 4, 5, 6, 10, 14, and 24 hours post-dose)|Plasma PK population includes all participants with at least one quantifiable PK concentration.||μg*h/mL||Standard Deviation|Mean
826442|NCT01190150|Primary|Area Under the Concentration Versus Time Curve From 0 to the Last Time Point (AUC0-t)|The area under the plasma concentration versus time curve, from time 0 to the last measurable concentration, as calculated by the linear trapezoidal method.|Day 1 or Day 8 (before dosing and at the following times thereafter: 0.5, 0.75, 1, 2, 2.5, 3.0, 3.5, 4, 5, 6, 10, 14, and 24 hours post-dose)|Plasma PK population includes all participants with at least one quantifiable PK concentration.||μg*h/mL||Standard Deviation|Mean
826443|NCT01190150|Primary|Time to Maximum Concentration Level (Tmax)|Time of the maximum measured plasma concentration. If the maximum value occurs at more than one time point, Tmax is defined as the first time point with this value.|Day 1 or Day 8 (before dosing and at the following times thereafter: 0.5, 0.75, 1, 2, 2.5, 3.0, 3.5, 4, 5, 6, 10, 14, and 24 hours post-dose)|Plasma PK population includes all participants with at least one quantifiable PK concentration.||hours||Standard Deviation|Mean
826444|NCT01190150|Primary|Dose-normalized Maximum Concentrations Level (Cmax)|Cmax is the maximum measured plasma concentration over the time-span specified and normalized to the 1.3 g dose.|Day 1 or Day 8 (before dosing and at the following times thereafter: 0.5, 0.75, 1, 2, 2.5, 3.0, 3.5, 4, 5, 6, 10, 14, and 24 hours post-dose)|Plasma PK population includes all participants with at least one quantifiable PK concentration.||μg/mL||Standard Deviation|Mean
826445|NCT01190150|Primary|Maximum Concentrations Level (Cmax)|Cmax is the maximum measured plasma concentration over the time-span specified.|Day 1 or Day 8 (before dosing and at the following times thereafter: 0.5, 0.75, 1, 2, 2.5, 3.0, 3.5, 4, 5, 6, 10, 14, and 24 hours post-dose)|Plasma PK population includes all participants with at least one quantifiable PK concentration.||μg/mL||Standard Deviation|Mean
826446|NCT01190215|Primary|Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.|"Fluarix vaccine strain was Flu A/California/7/2009 (H1N1).
MGI is defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titre to the pre-vaccination (Day 0) reciprocal HI titre.
Day 28 data were presented for the Fluarix Group only."|At Day 28|The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose.||Ratio||95% Confidence Interval|Geometric Mean
826447|NCT01190215|Primary|Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.|"Fluarix vaccine strain was Flu A/California/7/2009 (H1N1).
A seroprotected subject was a subject with a serum HI titre ≥ 1:40 that usually is accepted as indicating protection.
Day 28 data were presented for the Fluarix Group only."|At Day 0 and Day 28|The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose.||Subjects|||Number
826462|NCT01190215|Secondary|Number of Seroconverted Subjects for Neutralising Antibodies Against All Fluarix Vaccine Strains.|"A seroconverted subject for neutralising antibodies was a subject with a minimum 4-fold increase in titre at post-vaccination.
Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Perth/16/09 (H3N2) and B/Brisbane/60/2008.
At Month 6, only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group."|At Month 6|Analysis was performed on According-to-Protocol (ATP) cohort for antibody persistence at Month 6 which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at Month 6.||Subjects|||Number
826448|NCT01190215|Primary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.|"Fluarix vaccine strain was Flu A/California/7/2009 (H1N1).
A seroconverted subject was a subject who had either a pre-vaccination (Day 0) titre less than (< ) 1:10 and a post-vaccination titre greater than or equal to ( ≥) 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre.
Day 28 data were presented for the Fluarix Group only."|At Day 28|The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose.||Subjects|||Number
826449|NCT01190215|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|During the entire study period (Up to Month 6)|The Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
826450|NCT01190215|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|Within the 28-day (Days 0-27) post-vaccination period|The Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
826451|NCT01190215|Secondary|Number of Subjects Reporting Adverse Events of Special Interest.|Adverse events of special interest for safety monitoring includes both convulsion and anaphylaxis.|During the entire study period (Up to Month 6)|The Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
826452|NCT01190215|Secondary|Number of Subjects Reporting Adverse Events of Specific Interest (AESIs)/Potential Immune Mediated Diseases (pIMDs).|Potential Immune-Mediated Diseases (pIMDs) or Adverse events of specific interest (AESI), are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.|During the entire study period (Up to Month 6)|The Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
826453|NCT01190215|Secondary|Number of Subjects Reporting Medically-attended Events (MAEs).|For each solicited and unsolicited symptom the subject experienced, the subject was asked if they received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel for any reason.|During the entire study period (Up to Month 6)|The Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
826454|NCT01190215|Secondary|Number of Subjects Reporting Medically-attended Events (MAEs).|For each solicited and unsolicited symptom the subject experienced, the subject was asked if they received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel for any reason.|Within the 28-day (Days 0-27) post-vaccination period|The Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
826455|NCT01190215|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|"An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Grade 3 = event that prevented normal, everyday activities. Related = event assessed by the investigator as causally related to the study vaccination."|Within 28 days (Day 0 – Day 27) after vaccination|The Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
826456|NCT01190215|Secondary|Number of Days With Grade 3 Solicited General Symptoms.|"Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache and myalgia.
Grade 3 symptom = general symptom that prevented normal activity.
Inter-quartile range assessed was the 25th percentile and the 75th percentile."|Within 7 days (Day 0 – Day 6) after vaccination|The Total Vaccinated cohort included all vaccinated subjects.||Days||Inter-Quartile Range|Median
826457|NCT01190215|Secondary|Number of Days With Any Solicited General Symptoms.|"Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, sweating, temperature (temperature = axillary temperature equal to or above 37.5 degrees Celsius).
Inter-quartile range assessed was the 25th percentile and the 75th percentile."|Within 7 days (Day 0 – Day 6) after vaccination|The Total Vaccinated cohort included all vaccinated subjects.||Days||Inter-Quartile Range|Median
826458|NCT01190215|Secondary|Number of Days With Grade 3 Solicited Local Symptoms.|"Solicited local symptoms assessed were pain and swelling.
Grade 3 redness/swelling = redness/swelling above 50 millimetres.
Inter-quartile range assessed was the 25th percentile and the 75th percentile."|Within 7 days (Day 0 – Day 6) after vaccination|The Total Vaccinated cohort included all vaccinated subjects.||Days||Inter-Quartile Range|Median
826459|NCT01190215|Secondary|Number of Days With Any Solicited Local Symptoms.|"Solicited local symptoms assessed were pain, redness and swelling.
Inter-quartile range assessed was the 25th percentile and the 75th percentile."|Within 7 days (Day 0 – Day 6) after vaccination|The Total Vaccinated cohort included all vaccinated subjects.||Days||Inter-Quartile Range|Median
826460|NCT01190215|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms.|"Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, sweating, temperature (temperature = axillary temperature equal to or above 37.5 degrees Celsius).
Any = occurrence of any solicited general symptom regardless of intensity grade or relation to vaccination. Grade 3 symptom = general symptom that prevented normal activity. Grade 3 temperature = axillary temperature above 39.0 degrees Celsius."|Within 7 days (Day 0 – Day 6) after vaccination|The Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
826461|NCT01190215|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any solicited local symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling above 50 millimetres.|Within 7 days (Day 0 – Day 6) after vaccination|The Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
826463|NCT01190215|Secondary|Number of Seroconverted Subjects for Neutralising Antibodies Against All Fluarix Vaccine Strains.|"A seroconverted subject for neutralising antibodies was a subject with a minimum 4-fold increase in titre at post-vaccination.
Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Perth/16/09 (H3N2) and B/Brisbane/60/2008.
Day 28 data were presented for the Fluarix Group only."|At Day 28|The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose.||Subjects|||Number
826464|NCT01190215|Secondary|Geometric Mean Antibody Titres for Neutralising Antibodies Against All Fluarix Vaccine Strains.|"Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Perth/16/09 (H3N2) and B/Brisbane/60/2008.
Titres were expressed as geometric mean antibody titres (GMTs)."|At Day 0 and at Month 6|Analysis was performed on According-to-Protocol (ATP) cohort for antibody persistence at Month 6 which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at Month 6.||titre||95% Confidence Interval|Geometric Mean
826465|NCT01190215|Secondary|Geometric Mean Antibody Titres for Neutralising Antibodies Against All Fluarix Vaccine Strains.|"Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Perth/16/09(H3N2) and B/Brisbane/60/2008.
Day 28 data were presented for the Fluarix Group only.
Titres were expressed as geometric mean antibody titres (GMTs)."|At Day 0 and at Day 28|The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose.||titre||95% Confidence Interval|Geometric Mean
826466|NCT01190215|Secondary|Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.|"Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.
MGI is defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titre to the pre-vaccination (Day 0) reciprocal HI titre.
Only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group."|At Month 6|Analysis was performed on According-to-Protocol (ATP) cohort for antibody persistence at Month 6 which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at Month 6.||Ratio||95% Confidence Interval|Geometric Mean
826467|NCT01190215|Secondary|Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.|"Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.
MGI is defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titre to the pre-vaccination (Day 0) reciprocal HI titre.
Day 28 data were presented for the Fluarix Group only."|At Day 28|The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose.||Ratio||95% Confidence Interval|Geometric Mean
826468|NCT01190215|Secondary|Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.|"Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.
A seroprotected subject was a subject with a serum HI titre ≥ 1:40 that usually is accepted as indicating protection.
Only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group."|At Day 0 and Month 6|Analysis was performed on According-to-Protocol (ATP) cohort for antibody persistence at Month 6 which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at Month 6.||Subjects|||Number
826469|NCT01190215|Secondary|Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.|"Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.
A seroprotected subject was a subject with a serum HI titre ≥ 1:40 that usually is accepted as indicating protection.
Day 28 data were presented for the Fluarix Group only."|At Day 0 and Day 28|The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose.||Subjects|||Number
826470|NCT01190215|Secondary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.|"Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.
A seroconverted subject was a subject who had either a pre-vaccination (Day 0) titre < 1:10 and a post-vaccination titre ≥ 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre.
Only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group."|At Month 6|Analysis was performed on According-to-Protocol (ATP) cohort for antibody persistence at Month 6 which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at Month 6.||Subjects|||Number
826471|NCT01190215|Secondary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.|"Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.
A seroconverted subject was a subject who had either a pre-vaccination (Day 0) titre less than (< ) 1:10 and a post-vaccination titre greater than or equal to ( ≥) 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre.
Day 28 data were presented for the Fluarix Group only."|At Day 28|The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose.||Subjects|||Number
826512|NCT01196988|Secondary|Number of Days With Solicited Local Symptoms.|The number of days with any grade of local symptoms after Dose 1 and Dose 2 vaccination respectively was tabulated. Assessed solicited local symptoms for duration were pain, redness and swelling at the injection site.|During the 7-day (Days 0-6) follow-up period after vaccination.|The analysis was performed on the Total Vaccinated cohort, on vaccinated subjects with available results and with the symptom sheet completed.||days||Inter-Quartile Range|Median
826472|NCT01190215|Secondary|Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.|"Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.
Seropositivity was assessed for subjects with an antibody titre assay cut-off equal to or above 1:10.
Only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group."|At Day 0 and at Month 6|Analysis was performed on According-to-Protocol (ATP) cohort for antibody persistence at Month 6 which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at Month 6.||Subjects|||Number
826473|NCT01190215|Secondary|Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.|"Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.
Seropositivity was assessed for subjects with an antibody titre assay cut-off value equal to or above 1:10.
Day 28 data were presented for the Fluarix Group only."|At Day 0 and Day 28|The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose.||Subjects|||Number
826474|NCT01190215|Primary|Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.|"Fluarix vaccine strain was Flu A/California/7/2009 (H1N1).
Seropositivity was assessed for subjects with an antibody titre assay cut-off value equal to or above 1:10.
Day 28 data was presented only for the Fluarix Group."|At Day 0 and Day 28|The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose.||Subjects|||Number
826475|NCT01190215|Secondary|Geometric Mean Antibody Titres for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.|"Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.
Only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group.
Titres were expressed as geometric mean antibody titres (GMTs)."|At Day 0 and at Month 6|Analysis was performed on According-to-Protocol (ATP) cohort for antibody persistence at Month 6 which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at Month 6.||Titres||95% Confidence Interval|Geometric Mean
826476|NCT01190215|Primary|Geometric Mean Antibody Titres for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.|"Fluarix vaccine strain was Flu A/California/7/2009 (H1N1).
Day 28 data were presented only for the Fluarix Group.
Titres were expressed as geometric mean antibody titre."|At Day 0 and Day 28|The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose.||Titres||95% Confidence Interval|Geometric Mean
826477|NCT01190215|Secondary|Geometric Mean Antibody Titres for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.|"Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.
Day 28 data were presented for the Fluarix Group only.
Titres were expressed as geometric mean antibody titres (GMTs)."|At Day 0 and Day 28|The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose.||Titres||95% Confidence Interval|Geometric Mean
826478|NCT01196741|Secondary|Median PFS||From first saracatinib/placebo dose to first documented progression and/or death, assessed up to 36 months|||months||95% Confidence Interval|Median
826479|NCT01196741|Secondary|Median Time To Progression Based on RECIST v1.1 and GCIG CA125 Criteria|"Where a patient's disease is not measurable by RECIST v1.1, response may be based on GCIG CA125 criteria plus symptoms.
Time To Progression will be calculated by the trial statistician during the final analysis."|Using RECIST v1.1 at baseline; at Week 7 or 8 of each chemotherapy cycle; and 3 monthly during follow up. CA125 response will be assessed at baseline, weeks 1, 3 and 6 of each chemotherapy cycle, and at every follow up visit.||||||
826480|NCT01196741|Secondary|Quality of Life: Trial Outcome Index (TOI) Based on FACT-O|"The TOI value for each patient is derived at each timepoint by calculating the sum of 3 subscales: Physical Well-Being (PWB), Functional Well-Being (FWB), Additional Concerns. Each subscale score is derived from questions with 4 answers (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). In each subscale reversals are performed and the individual question scores added together. This value is then multiplied by the number of questions within the subscale, and divided by the number of questions answered to derive a subscale score. The higher each subscale score, the better the QoL.
PWB 7 questions, lower values=better QoL.
FWB 7 questions, higher values=better QoL.
Additional concerns 11 questions (higher values in 6 questions=better QoL; higher values in 5 questions=worse QoL)
The TOI is reported for each arm based on the average TOI score of each patient calculated across the outcome measure time frame. The higher the TOI, the better the QoL."|Patients will fill in FACT-O questionnaires at the following timepoints: baseline; Weeks 1, 3 and 6 of every chemotherapy cycle; at every follow up visit|||units on a scale||Standard Error|Mean
826481|NCT01196741|Secondary|Median Duration of Response|"Where a patient's disease is not measurable by RECIST v1.1, response may be based on GCIG CA125 criteria plus symptoms.
Duration of Response will be calculated by the trial statistician during the final analysis."|Using RECIST v1.1 at baseline; at Week 7 or 8 of each chemotherapy cycle; and 3 monthly during follow up. CA125 response will be assessed at baseline, weeks 1, 3 and 6 of each chemotherapy cycle, and at every follow up visit.||||||
826482|NCT01196741|Secondary|Objective Response Rate Based on Investigator Assessment Based on RECIST v1.1 +/- GCIG CA125 Criteria|Where a patient's disease is not measurable by RECIST v1.1, response may be based on GCIG CA125 criteria plus symptoms.|Using RECIST v1.1 at baseline; at Week 7 or 8 of each chemotherapy cycle; and 3 monthly during follow up. CA125 response will be assessed at baseline, weeks 1, 3 and 6 of each chemotherapy cycle, and at every follow up visit.|||percentage of participants|||Number
826483|NCT01196741|Secondary|Overall Survival||First saracatinib/placebo dose until death, assessed up to 36 months|||months||Full Range|Median
826484|NCT01196741|Primary|6 Month Progression-free Survival Rate (PFS) (Based on Combined Response Evaluation Criteria In Solid Tumours (RECIST) v1.1 +/- Gynecologic Cancer Intergroup (GCIG) CA125 Criteria)|"Where a patient's disease is not measurable by RECIST v1.1, response may be based on GCIG CA125 criteria plus symptoms.
The 6 month progression-free survival rate will be calculated by the trial statistician during the final analysis."|Using RECIST v1.1 at baseline; at Week 7 or 8 of each chemotherapy cycle; and 3 monthly during follow up. CA125 response will be assessed at baseline, weeks 1, 3 and 6 of each chemotherapy cycle, and at every follow up visit.|||percentage of participants||90% Confidence Interval|Number
826485|NCT01196923|Primary|Acute Isolation of Pulmonary Veins.|99% of pulmonary veins were isolated (72/73)|Acute PVI measured on the day of treatment|All treated participants with reported data.||percent isolated pulmonary veins|||Number
826486|NCT01196975|Secondary|Number of Days With Unsolicited Adverse Events (AEs) After Vaccination|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any: any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented normal everyday activity. Analyses of duration for unsolicited AEs were not performed.|Within the 21-day (Days 0-20) follow-up period post vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||||
826487|NCT01196975|Secondary|Number of Days With Solicited General Symptoms After Vaccination|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (Gastr.), headache, muscle ache, shivering, temperature (defined as oral temperature equal to or above 38.0 degrees Celsius) and joint pain at location other than the injection site (Joint Pain). Joint pain data were collected for subjects in Canada and Mexico only. Analyses of duration for solicited general symptoms were not performed.|Within the 7-day follow-up period after vaccination (Days 0-6)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, on subjects for whom results were available.|||||
826488|NCT01196975|Secondary|Number of Days With Solicited Local Symptoms After Vaccination.|Solicited local symptoms were pain, redness and swelling at the injection site. Analyses of duration for solicited local symptoms were not performed.|Within the 7-day follow-up period after vaccination (Days 0-6)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, on subjects for whom results were available.|||||
826489|NCT01196975|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented normal everyday activity Related: unsolicited AE assessed by the investigator as related to the vaccination.|Within the 21-day (Days 0-20) follow-up period after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subject|||Number
826490|NCT01196975|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (Gastr. Symptoms), headache, muscle ache, shivering, temperature – oral temperature equal to or above (≥) 38.0 degrees Celsius (°C) - and joint pain at location other than the injection site (Joint Pain). Grade 3 temperature = temperature ≥ 39.0 °C. Grade 3 symptom = symptom that prevented normal everyday activity. Related symptom = symptom assessed by the investigator as causally related to study vaccination. Joint pain data were collected for subjects in Canada and Mexico only.|Within the 7-day (Days 0-6) follow-up period after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, on subjects for whom results were available.||Subject|||Number
826491|NCT01196975|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling at the injection site. Grade 3 pain = significant pain at rest/pain that prevented normal everyday activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|Within the 7-day (Days 0-6) follow-up period after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, on subjects for whom results were available.||Subject|||Number
826492|NCT01196975|Secondary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0 (i.e. the geometric mean of the within-subject ratios of the Day 21 reciprocal HI titer to the Day 0 reciprocal HI titer). The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains.|At Day 21 (D21) post vaccination.|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||Titer||95% Confidence Interval|Geometric Mean
826493|NCT01196975|Secondary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0 (i.e. the geometric mean of the within-subject ratios of the Day 21 reciprocal HI titer to the Day 0 reciprocal HI titer). The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains. Subjects were assessed according to 2 age categories, 18-60Y and ≥ 61Y.|At Day 21 (D21) post vaccination.|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||Titer||95% Confidence Interval|Geometric Mean
826513|NCT01196988|Secondary|Number of Subjects With Any and Related Serious Adverse Events (SAEs).|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the entire study period (Day 0 - Day 180)|The analysis was performed on the Total Vaccinated cohort, on vaccinated subjects with available results.||subjects|||Number
826494|NCT01196975|Secondary|Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains. Subjects were assessed according to 2 age categories, 18-60Y and ≥ 61Y.|At Day 21 (D21) after vaccination.|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||Subject|||Number
826495|NCT01196975|Secondary|Number of Seroconverted Subjects Against 4 Strains of Influenza|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains.|At Day 21 (D21) after vaccination.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||Subject|||Number
826496|NCT01196975|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. Antibodies assessed were antibodies against the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 flu strains.|At Day 0 (D0), and at Day 21 (D21) and Day 180 (D180) post vaccination.|The analysis was performed on the According-To-Protocol cohort for persistence, which included all vaccinated subjects who had not received a vaccine forbidden in the protocol, and with available assay results at Day 180 for assessed antibodies.||Titer||95% Confidence Interval|Geometric Mean
826497|NCT01196975|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata|Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. Antibodies assessed were antibodies against the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 flu strains. Subjects were assessed according to 2 age categories, 18-60Y and ≥ 61Y.|At Day 0 (D0) and at Day 21 (D21) post vaccination.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||titer||95% Confidence Interval|Geometric Mean
826498|NCT01196975|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. Antibodies assessed were antibodies against the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains. Results for Day 21 for the subjects in the GSK2282512A Group are the results specific to this primary outcome measure.|At Day 0 (D0) and at Day 21 (D21) post vaccination.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||Titer||95% Confidence Interval|Geometric Mean
826499|NCT01196975|Secondary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0 (i.e. the geometric mean of the within-subject ratios of the Day 21 reciprocal HI titer to the Day 0 reciprocal HI titer). The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains. Subjects were assessed according to 2 age categories, 18-64Y and ≥ 65Y.|At Day 21 (D21) after vaccination|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||Titer||95% Confidence Interval|Geometric Mean
826500|NCT01196975|Secondary|Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains. Subjects were assessed according to 2 age categories, 18-64Y and ≥ 65Y.|At Day 21 (D21) after vaccination.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||Subject|||Number
826501|NCT01196975|Secondary|Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition titer ≥ 1:40. The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains. Subjects were assessed according to 2 age categories, 18-64Y and ≥ 65Y.|At Day 0 (D0) and at Day 21 (D21) after vaccination|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||Subject|||Number
827502|NCT01207570|Primary|Ankle Passive Range of Motion|Ankle passive range of motion at day 4 before the crossover treatment|day 4 before treatment|All subjects received the intended treatment protocol and were included in the analysis. ITT was used to analyze the data.||degree||Standard Deviation|Mean
826502|NCT01196975|Secondary|Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition titer ≥ 1:40. The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains. Subjects were assessed according to 2 age categories, 18-60Y and ≥ 61Y.|At Day 0 (D0) and at Day 21 (D21) after vaccination.|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||subject|||Number
826503|NCT01196975|Secondary|Number of Seroprotected Subjects Against 4 Strains of Influenza Disease|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition titer ≥ 1:40. The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains|At Day 0 (D0) and at Day 21 (D21) after vaccination.|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||Subject|||Number
826504|NCT01196975|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata|Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. Antibodies assessed were antibodies against the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 flu strains. Subjects were assessed according to 2 age categories, 18-64Y and ≥ 65Y.|At Day 0 (D0), and at Day 21 (D21) and Day 180 (D180) post vaccination.|The analysis was performed on the According-To-Protocol cohort for persistence, which included all vaccinated subjects who had not received a vaccine forbidden in the protocol, and with available assay results at Day 180 for assessed antibodies.||Titer||95% Confidence Interval|Geometric Mean
826505|NCT01196975|Secondary|Number of Subjects With Any and Related Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From the beginning of the study until study end (from Day 0 to Day 180)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subject|||Number
826506|NCT01196975|Secondary|Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) are a subset of adverse events that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Related pIMD = pIMD assessed by the investigator to be causally related to vaccination.|From the beginning of the study until study end (from Day 0 to Day 180) .|The analysis was performed on the Total Vaccinated cohort, on subjects with available results.||Subject|||Number
826507|NCT01196975|Secondary|Number of Subjects With Related Medically-attended Adverse Events (MAEs)|Medically-attended adverse events (MAEs) were non-serious and serious events leading to an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits. If a medically-attended adverse event was leading to hospitalization (or met any other serious adverse event [SAE] criterion), it was reported as SAE. Related MAE = MAE assessed by the investigator to be causally related to vaccination. Relationship to vaccination was not computed for MAEs.|From the beginning of the study until study end (from Day 0 to Day 180) .|The analysis was performed on the Total Vaccinated cohort, on subjects with available results.|||||
826508|NCT01196975|Secondary|Number of Subjects With Medically-attended Adverse Events (MAEs)|Medically-attended adverse events (MAEs) were non-serious and serious events leading to an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits. If a medically-attended adverse event was leading to hospitalization (or met any other serious adverse event [SAE] criterion), it was reported as SAE.|From the beginning of the study until study end (from Day 0 to Day 180)|The analysis was performed on the Total Vaccinated cohort, on subjects with available results.||Subject|||Number
826509|NCT01196975|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata|Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. Antibodies assessed were antibodies against the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 flu strains. Subjects were assessed according to 2 age categories, 18-60Y and ≥ 61Y.|At Day 0 (D0), and at Day 21 (D21) and Day 180 (D180) post vaccination.|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all vaccinated subjects who had not received a vaccine forbidden in the protocol with available assay results for assessed antibodies in Day 180 blood samples.||titer||95% Confidence Interval|Geometric Mean
826510|NCT01196975|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata|Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. Antibodies assessed were antibodies against the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 flu strains. Subjects were assessed according to 2 age categories, 18-64Y and ≥ 65Y.|At Day 0 (D0) and at Day 21 (D21) post vaccination.|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||titer||95% Confidence Interval|Geometric Mean
826511|NCT01196988|Secondary|Number of Days With Solicited General Symptoms|The number of days with any grade of local symptoms after Dose 1 and Dose 2 vaccination respectively was tabulated. Assessed solicited general symptoms for duration were drowsiness, fatigue, gastrointestinal symptoms (Gastro.), headache, irritability, loss of appetite, muscle aches, shivering and temperature [axillary temperature equal to or above 37.5 degrees Celsius (°C)].|During the 7-day (Days 0-6) follow-up period after vaccination.|The analysis was performed on the Total Vaccinated cohort, on vaccinated subjects with available results and with the symptom sheet completed.||days||Inter-Quartile Range|Median
826514|NCT01196988|Secondary|Number of Subjects With Any and Related Potential Immune-Mediated Diseases (pIMDs).|pIMDs were defined as a subset of AEs that included both clearly autoimmune diseases (AID) and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.|During the entire study period (Day 0 - Day 180)|The analysis was performed on the Total Vaccinated cohort, on vaccinated subjects with available results||subjects|||Number
826515|NCT01196988|Secondary|Number of Subjects With Any, Grade 3 and Related Medically Attended Adverse Events (MAEs).|MAEs were defined as AEs that resulted in medical attention (defined as hospitalization, an emergency room visit or a visit to or from medical personnel for any reason). Any = any MAE regardless of intensity or relationship to vaccination. Grade 3 MAE = MAE which prevented normal, everyday activities. Related = MAE assessed by the investigator as related to the vaccination. Assessment of intensity for MAEs was not performed.|During the entire study period (Day 0 - Day 180)|The analysis was performed on the Total Vaccinated cohort, on vaccinated subjects with available results.||subjects|||Number
826516|NCT01196988|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented normal activity Related = unsolicited AE assessed by the investigator as related to the vaccination.|During the 28-day (Days 0-27) follow-up period after any vaccination.|The analysis was performed on the Total Vaccinated cohort, on vaccinated subjects with available results.||subjects|||Number
826517|NCT01196988|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older.|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature [axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of any solicited general symptom regardless of intensity grade or relation to vaccination. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 irritability = crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = not eating at all. Related = general symptom assessed by the investigator as causally related to the study vaccination. Grade 3 temperature = temperature >39.0°C.|During the 7-day (Days 0-6) follow-up period after any vaccination.|The analysis was performed on the Total Vaccinated cohort, on vaccinated subjects with available results and with the symptom sheet completed.||subjects|||Number
826518|NCT01196988|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old.|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature [axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of any solicited general symptom regardless of intensity grade or relation to vaccination. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 irritability = crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = not eating at all. Related = general symptom assessed by the investigator as causally related to the study vaccination. Grade 3 temperature = temperature >39.0°C.|During the 7-day (Days 0-6) follow-up period after any vaccination.|The analysis was performed on the Total Vaccinated cohort, on vaccinated subjects with available results and with the symptom sheet completed.||subjects|||Number
826519|NCT01196988|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms.|Assessed solicited local symptoms were pain, redness and swelling at the injection site. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = Cried when limb was moved/spontaneously painful (Child <6 years) or pain that prevented normal activity (Child >6 years). Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of the injection site.|During the 7-day (Days 0-6) follow-up period after any vaccination.|The analysis was performed on the Total Vaccinated cohort, on vaccinated subjects with available results and with the symptom completed.||subjects|||Number
826520|NCT01196988|Secondary|Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.|MGI is defined as the geometric mean of the within subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 6 -17 months and 18-35 months.|At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||fold increase||95% Confidence Interval|Geometric Mean
826521|NCT01196988|Secondary|Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.|MGI is defined as the geometric mean of the within subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 3-8 years and 9-17 years.|At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||fold increase||95% Confidence Interval|Geometric Mean
826522|NCT01196988|Secondary|Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.|MGI is defined as the geometric mean of the within subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).|At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||fold increase||95% Confidence Interval|Geometric Mean
826523|NCT01196988|Secondary|Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.|A seroprotected subject was defined as as a vaccinated subject who had a serum HI titer ≥ 1:120. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 6 -17 months and 18-35 months.|At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||subjects|||Number
826524|NCT01196988|Secondary|Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.|A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:120. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 3-8 years and 9-17 years.|At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||subjects|||Number
826525|NCT01196988|Secondary|Number of Seroprotected Subjects Against 4 Strains of Influenza Disease.|A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:120. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).|At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||subjects|||Number
826526|NCT01196988|Secondary|Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.|A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:80. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 6-17 months and 18-35 months.|At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||subjects|||Number
826527|NCT01196988|Secondary|Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.|A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:80. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 3-8 years and 9-17 years.|At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||subjects|||Number
826528|NCT01196988|Secondary|Number of Seroprotected Subjects Against 4 Strains of Influenza.|A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:80. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).|At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||subjects|||Number
826529|NCT01196988|Secondary|Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.|A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 6-17 months and 18-35 months.|At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||subjects|||Number
826530|NCT01196988|Secondary|Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.|A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 3-8 years and 9-17 years.|At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||subjects|||Number
826558|NCT01197911|Secondary|Apparent Total Body Clearance (CL/F) of Aleglitazar|CL/F was calculated as dose/AUCinf, where AUCinf represents the area under the concentration-time curve of the analyte in plasma over the time interval from zero extrapolated to infinity.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol.||L/h||Geometric Coefficient of Variation|Geometric Mean
826531|NCT01196988|Secondary|Number of Seroprotected Subjects Against 4 Strains of Influenza Disease|A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).|At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||subjects|||Number
826532|NCT01196988|Secondary|Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 6-17 months and 18-35 months.|At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||subjects|||Number
826533|NCT01196988|Secondary|Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 3-8 years and 9-17 years.|At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||subjects|||Number
826534|NCT01196988|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.|"Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).
Subjects were assessed according to 2 age strata: 6-17 months and 18-35 months."|At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||titers||95% Confidence Interval|Geometric Mean
826535|NCT01196988|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.|"Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).
Subjects were assessed according to 2 age strata: 3-8 years and 9-17 years."|At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||titers||95% Confidence Interval|Geometric Mean
826536|NCT01196988|Primary|Number of Seroconverted Subjects Against 4 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).|At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||subjects|||Number
826537|NCT01196988|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).|At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||titers||95% Confidence Interval|Geometric Mean
826538|NCT01197898|Primary|Change From Baseline in Extent of Presence/Absence of Epithelial Tongue.|The results were found to be inconclusive due to the small number of biopsy specimens of sufficient quality for analysis. Four of the 10 subjects enrolled were not evaluable due to poor biopsy quality.|28 Days|Goal was to complete 10 subjects in an allocation ratio of 1:1 for Santyl vs. placebo. Since this was an exploratory study, the sample size was arbitrary.||participants|||Number
826539|NCT01197911|Secondary|Number of Participants With Marked Abnormalities in Clinical Laboratory Parameters|Laboratory parameters included hematology, coagulation, biochemistry, and urinalysis. A marked abnormality was defined as a test result which was outside of the marked abnormality range. Data was reported as the number of participants who had low level values (values less than the normal range) and high level values (values more than the normal range).|Up to 6 weeks|The safety analysis consisted of all participants who had received the single dose of the study drug (aleglitazar), whether prematurely withdrawn from the study or not.||participants|||Number
826540|NCT01197911|Secondary|Number of Participants With Low and High Vital Signs Values|Vital signs were assessed after participants had rested in a supine position for no less than 5 minutes. Vital signs included systolic blood pressure, diastolic blood pressure, pulse rate, and oral body temperature. The normal ranges of vital signs were: systolic blood pressure as 90-140 millimeter of Hg (mm Hg), diastolic blood pressure as 50-90 mm Hg, pulse rate as 45-100 beats per minute, and oral body temperature as 36.3-37.5 degree Celsius. Data was reported as the number of participants who had low level values (values less than the normal range) and high level values (values more than the normal range).|Days -28 to -2, Day -1, Days 1 to 5, and Day 10 for blood pressure and pulse rate; and Days -28 to -2, Day -1, and Day 10 for oral body temperature|The safety analysis consisted of all participants who had received the single dose of the study drug (aleglitazar), whether prematurely withdrawn from the study or not.||participants|||Number
826541|NCT01197911|Secondary|Number of Participants With Low and High Electrocardiograms (ECGs) Parameter Values|The ECG evaluations were performed after participants were at rest and in supine position for at least 5 minutes before recording and remain resting and supine during the recordings. ECGs parameters included heart rate (HR), RR interval, PR interval, QRS duration, QT interval, QTcB, and QTcF intervals. The normal ranges of ECG parameter values were: HR as 40-100 beats per minute, RR as 600-1500 milliseconds (msec), PR as 120-200 msec, QRS as 80-120 msec, QT as 200-500 msec, QTcB as 350-450 msec, and QTcF as 350-450 msec. Data was reported as the number of participants who had low level values (values less than the normal range) and high level values (values more than the normal range).|Screening (Days -28 to -2), baseline (Day -1), Days 1 to 5, and follow-up visit (Day 10)|The safety analysis consisted of all participants who had received the single dose of the study drug (aleglitazar), whether prematurely withdrawn from the study or not.||participants|||Number
826542|NCT01197911|Secondary|Number of Participants With Any Adverse Events (AEs), Serious Adverse Events (SAEs), Death, and Study Discontinuation|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.|Up to 6 weeks|The safety analysis consisted of all participants who had received the single dose of the study drug (aleglitazar), whether prematurely withdrawn from the study or not.||participants|||Number
826543|NCT01197911|Secondary|Apparent Unbound Total Body Clearance (CL/Fu) of Aleglitazar|CL/F is an apparent total clearance of the drug from plasma after oral administration. It was calculated as dose/AUCinf. AUCinf represents the area under the concentration-time curve of the analyte in plasma over the time interval from zero extrapolated to infinity.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose for plasma; 0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose for urine|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific study drug/metabolite were analyzed.||L/h||Geometric Coefficient of Variation|Geometric Mean
826544|NCT01197911|Secondary|Apparent Unbound Volume of Distribution (Vz/Fu) of Aleglitazar|VzF/u is an apparent volume of Unbound distribution during terminal phase after non-intravenous administration. It was calculated as CL/F/kel, where CL/F was calculated as dose/AUCinf, where AUCinf represents the area under the concentration-time curve of the analyte in plasma over the time interval from zero extrapolated to infinity and kel as constant elimination rate of aleglitazar.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose for plasma; 0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose for urine|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed. Only participants with data available for specific study drug/metabolite were analyzed.||L||Geometric Coefficient of Variation|Geometric Mean
826545|NCT01197911|Secondary|Area Under the Unbound Plasma Concentration-time Curve of Aleglitazar From Time 0 to 48 Hours Post-dose (AUCu,0-48)|AUClast represents the area under the concentration-time curve of the analyte in plasma over the time interval from zero to the 48 hours post-dose. It was calculated by non-compartmental analysis using the linear trapezoidal rule, using relative actual time values.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed. Only participants with data available for specific study drug/metabolite were analyzed.||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
826546|NCT01197911|Secondary|Area Under the Unbound Plasma Concentration-time Curve of Aleglitazar From 0 to the Last Quantifiable Time-point Post-dose (AUCu,Last)|Plasma samples were collected for this PK parameter. AUClast represents the area under the concentration-time curve of the analyte in plasma over the time interval from zero 0 to the last quantifiable time-point post-dose. It was calculated by non-compartmental analysis using the linear trapezoidal rule, using relative actual time values. AUClast was extrapolated to AUCinf by adding the ratio of Clast/kel to the AUClast, where Clast was the last observed concentration and kel was elimination rate constant.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed. Only participants with data available for specific study drug/metabolite were analyzed.||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
826547|NCT01197911|Secondary|Maximum Unbound Plasma Concentration (Cmax,u) of Aleglitazar|Cmax was obtained directly from the concentration-time data.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed. Only participants with data available for specific study drug/metabolite were analyzed.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
826597|NCT01198600|Primary|Phase 3: Ocular Comfort, Lens Age 14 Days, End of Day|Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 14 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE (“I CANNOT tolerate the comfort of my eyes! I am in pain!”)and 100=VERY COMFORTABLE & FRESH (“Wow! My eyes feel incredible! I love this feeling.”)|Day 15|All enrolled and dispensed participants, Phase 3.||Units on a scale||Standard Deviation|Mean
826548|NCT01197911|Secondary|Area Under the Unbound Plasma Concentration-time Curve of Aleglitazar From Time 0 to Infinity (AUCu,Inf)|AUCinf represents the area under the concentration-time curve of the analyte in plasma over the time interval from zero extrapolated to infinity. It was calculated by non-compartmental analysis using the linear trapezoidal rule, using relative actual time values. It was assessed using an analysis of variance model on the log-transformed values of AUCinf of aleglitazar with hepatic impairment group as factor.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed. Only participants with data available for specific study drug/metabolite were analyzed.||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
826549|NCT01197911|Secondary|Mean of Fraction of Unbound Aleglitazar (fu)|fu was calculated using the mean of the 2-hour (reflecting Cmax) and 24-hour (reflecting Ctrough) values for each participant or, if the result of only one time-point was available, fu was the result of the available time-point. Ctrough) is a measured concentration at the end of a dosing interval at steady state.|2 and 24 hours post-dose|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed. Only participants with data available for specific study drug/metabolite were analyzed.||Percentage||Geometric Coefficient of Variation|Geometric Mean
826550|NCT01197911|Secondary|Fraction of Drug Excreted in Urine From Time 0 to 48 Hours Post-dose (fe0-48) of Aleglitazar|fe0-48 was calculated as Ae0-48/dose. The cumulative amount excreted in urine Ae0-48 over the entire collection interval of 48 hours was calculated by adding the Ae of the intervals 0-4, 4-8, 8-12, 12-24, and 24-48 hours. Ae was calculated by multiplying the urine volume within the collection interval by the associated drug concentration.|0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed. Only participants with data available for specific study drug/metabolite were analyzed.||mcg||Geometric Coefficient of Variation|Geometric Mean
826551|NCT01197911|Secondary|Amount Excreted in Urine From Time 0 to 48 Hours Post-dose (Ae0-48) of Aleglitazar, M1, and M6|The cumulative amount excreted in urine Ae0-48 over the entire collection interval of 48 hours was calculated by adding the Ae of the intervals 0-4, 4-8, 8-12, 12-24, and 24-48 hours, where Ae was calculated by multiplying the urine volume within the collection interval by the associated drug concentration.|0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed.||mcg||Geometric Coefficient of Variation|Geometric Mean
826552|NCT01197911|Secondary|Apparent Volume of Distribution (Vz/F) of Aleglitazar|Vz/F is the apparent volume of distribution during terminal phase after non-intravenous administration. It was calculated as CL/F/kel, where CL/F was calculated as dose/AUCinf, where AUCinf represents the area under the concentration-time curve of the analyte in plasma over the time interval from zero extrapolated to infinity and kel as constant elimination rate of aleglitazar.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose for plasma; 0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose for urine|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol.||L||Geometric Coefficient of Variation|Geometric Mean
826553|NCT01197911|Secondary|Elimination Rate Constant (Kel) of Aleglitazar|The kel is fraction of a substance that is removed per unit time measured at any particular instant. It was calculated using at least 3 concentration-time points and ideally covered more than 2 half-lives.|0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol.||1/h||Geometric Coefficient of Variation|Geometric Mean
826554|NCT01197911|Secondary|Apparent Terminal Half-life (t½) of Aleglitazar, M1, and M6|M1 and M6 are pharmacologically inactive metabolites of aleglitazar. T1/2 is the time required for a given drug concentration in the plasma to decrease by 50%.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed.||h||Geometric Coefficient of Variation|Geometric Mean
826555|NCT01197911|Secondary|Time of Maximum Plasma Concentration (Tmax) of Aleglitazar, M1, and M6|M1 and M6 are pharmacologically inactive metabolites of aleglitazar. Tmax was measured as time to reach the maximum concentration in the plasma after post-dose.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol.||h||Full Range|Mean
826556|NCT01197911|Secondary|Apparent Non-renal Clearance (CLNR/F) of Aleglitazar|Plasma and urine samples were collected for this PK parameter. CLNR/F was estimated as CL/F, based on the approximated formula of CLNR/F = (CL-CLR)/F with CLR of aleglitazar being equal to zero. CL/F was calculated as dose/AUCinf, where AUCinf represents the area under the concentration-time curve of the analyte in plasma over the time interval from zero extrapolated to infinity. CLR was calculated as Ae0-48/AUC0-48, where Ae0-48 as amount excreted in urine from time zero to 48 hours post-dose and AUC0-48 represents area under the concentration-time curve of the analyte in plasma over the time interval from zero to the 48 hours post-dose.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose for plasma; 0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose for urine|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed.||L/h||Geometric Coefficient of Variation|Geometric Mean
826557|NCT01197911|Secondary|Renal Clearance (CLR) of Aleglitazar, M1, and M6|CLR was calculated as Ae0-48/AUC0-48, where Ae0-48 as amount excreted in urine from time 0 to 48 hours post-dose and AUC0-48 represents area under the concentration-time curve of the analyte in plasma over the time interval from zero to the 48 hours post-dose.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72, and 96 hours post-dose for plasma; 0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose for urine|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed.||L/h||Geometric Coefficient of Variation|Geometric Mean
826559|NCT01197911|Secondary|Area Under the Plasma Concentration-time Curve From 0 to the Last Quantifiable Time-point Post-dose (AUClast) of Aleglitazar, M1, and M6|AUClast was calculated by non-compartmental analysis using the linear trapezoidal rule, using relative actual time values.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed.||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
826560|NCT01197911|Secondary|Area Under the Plasma Concentration-time Curve From Time 0 to 48 Hours Post-dose (AUC0-48) of Aleglitazar, M1, and M6|M1 and M6 are pharmacologically inactive metabolites of aleglitazar. AUC0-48 was calculated by non-compartmental analysis using the linear trapezoidal rule, using relative actual time values.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed.||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
826561|NCT01197911|Secondary|Cmax of M1 and M6|M1 and M6 are pharmacologically inactive metabolites of aleglitazar. Cmax was obtained directly from the concentration-time data.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
826562|NCT01197911|Primary|Maximum Plasma Concentration (Cmax) of Aleglitazar|Cmax was obtained directly from the concentration-time data.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose|The pharmacokinetics (PK) analysis population consisted of all participants who received the study drug and adhered to the protocol.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
826563|NCT01197911|Secondary|AUCinf of M1 (RO4408754) and M6 (RO4583746)|M1 and M6 are pharmacologically inactive metabolites of aleglitazar. AUCinf represents the area under the concentration-time curve of the analyte in plasma over the time interval from zero extrapolated to infinity. AUCinf was calculated by non-compartmental analysis using the linear trapezoidal rule, using relative actual time values.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed.||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
826564|NCT01197911|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf) of Aleglitazar|AUCinf was calculated by non-compartmental analysis using the linear trapezoidal rule, using relative actual time values.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose|The pharmacokinetics (PK) analysis population consisted of all participants who received the study drug and adhered to the protocol.||hours (h)*nanogram (ng)/milliliter (mL)||Geometric Coefficient of Variation|Geometric Mean
826565|NCT01198145|Secondary|Percentage of Patients in Each Arm That Experience Clinically Significant Deficits in Overall Quality of Life and Fatigue|For each arm, the percentage of patients experience clinically significant deficits in overall QOL and fatigue as indicated by a score of 5 or lower on the 0-10 scale. The analysis was done using the questionnaire that was completed during the first week of radiotherapy (RT) and 6 weeks after RT.|Up to 6 weeks post radiotherapy|All completed QOL questionnaires were included in the analysis. Questionnaires used were completed during the first week during RT and 6 weeks after RT. From Arm I, 41 patients completed questionnaires, 39 during and 26 after RT. For Arm II, 42 patients completed the questions, 40 during and 29 after RT.||percentage of participants|||Number
826566|NCT01198145|Secondary|Percentage of Patients in Each Arm That Require Any Type of Antidiarrheal Medications.|The number of patients reporting the use of anti-diarrheal medications divided by the number of patients evaluated for this endpoint.|Up to 24 months post radiotherapy|Two patients in Arm I and one patient from Arm II were not included in the endpoint analyses due to cancellations and protocol violations.||percentage of participants|||Number
826567|NCT01198145|Secondary|"Percent of Patients in Each Arm That Recorded Yes to Each of Questions 2-10 on the Bowel Function Questionnaire"|"Questions that were used in this analysis:
2. Have you had a problem causing you to get up at night to have a bowel movement? 3. Have you had a problem causing you to lose control of your bowel movements? 4. Have you had a problem causing you to have a bowel movement within 30 minutes of a prior bowel movement? 5. Have you had to wear protective clothing or a pad in case you lost control of a bowel movement? 6. Have you had a problem causing you to be unable to tell the difference between stool and gas? 7. Have you had a problem causing you to have stools that are liquid? 1=yes 2=no q08 8. Have you found that once you feel the urge to have a bowel movement, you must do so within 15 minutes to avoid an accident? 9. Have you had cramping with a bowel movement? 10. Have you had blood in your bowel movement?"|Up to 6 weeks post radiation therapy|All patients that completed the questionnaire were included in the analysis. Questionnaires used were completed during the last week during RT and 6 weeks after RT.||percentage of participants|||Number
826568|NCT01198145|Secondary|Percentage of Patients in Each Arm That Experience Tenesmus, Abdominal Pain, Constipation, Diarrhea and Rectal Bleeding During and After RT|The number of patients that reported any grade 1 or higher adverse event was divided by the total number of patients evaluated. The analysis was done separately for each of the 5 outcomes and separately during RT and after RT.|During radiation therapy and up to 6 weeks post radiation therapy|Two patients in Arm I and one patient from Arm II were not included in the endpoint analyses due to cancellations and protocol violations. 42 patients from each arm started RT and were used in that portion of the analysis. 25 patients from Arm I and 29 patients from Arm II were evaluated after RT. Two patients from Arm 1 provided incomplete data.||percentage of participants|||Number
826580|NCT01198366|Secondary|Interferon-gamma (IFN-gamma) Enzyme-linked Immunospot (ELISpot) Response: Spot Forming Units/10^6 PBMC According to ELISpot Assay|To evaluate the immunogenicity of AERAS-402 compared to controls. ELISpot assay of specific T cell responses after stimulation with a peptide pool of mycobacterial peptides. Values presented have been corrected for background readings.|28 days post last vaccination|"Groups 1 and 4: Subjects who received both vaccinations as randomized (assays were not done for Groups 2 and 3).
Group 5: Subjects who received all three study vaccinations as randomized."||SFU/10^6 PBMC||95% Confidence Interval|Median
826569|NCT01198145|Secondary|Average Graded Severity for Tenesmus, Abdominal Pain, Constipation, Diarrhea and Hemorrhage During and After RT as Graded by CTCAE v4.0|Tenesmus, Abdominal pain, constipation, diarrhea and hemorrhaging were assessed during RT and up to 6 weeks after RT. Severity of these events were graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 4.0. Grade 0 = None; 1=Mild; Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening. For each patient, an average score for each outcome variable during and after RT calculated as follows: The sum of all severity scores for that variable divided by the number of severity scores for that variable recorded for the patient during the course of RT and for 6 weeks following RT.|During radiation therapy and up to 6 weeks post radiation therapy|Two patients in Arm I and one patient from Arm II were not included in the endpoint analyses due to cancellations and protocol violations. 42 patients from each arm started RT and were used in that portion of the analysis. 25 patients from Arm I and 29 patients from Arm II were evaluated after RT. Two patients from Arm 1 provided incomplete data.||Average Grade of Event||Standard Deviation|Mean
826570|NCT01198145|Secondary|Area Under the Curve That Combines the Individual Severity of Diarrhea Toxicity as Measured by the CTCAE v4.0 During and After RT|For each patient, an Area Under the Curve (AUC) summary statistic will be calculated taking into account the individual severity of diarrhea toxicity over time. Severity of diarrhea was graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 4.0. Grade 0 = None; 1=Mild; Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening. The curve was constructed using weekly assessments during and after RT. A separate analysis was done during the course of RT and every week for 6 weeks following RT.|During radiation therapy and up to 6 weeks post radiation therapy|Two patients in Arm I and one patient from Arm II were not included in the endpoint analyses due to cancellations and protocol violations. 42 patients from each arm started RT and were used in that portion of the analysis. 25 patients from Arm I and 29 patients from Arm II were evaluated after RT. Two patients from Arm 1 provided incomplete data.||grade*week||Standard Deviation|Mean
826571|NCT01198145|Secondary|Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT|"The maximal severity of each of 5 different adverse even types (Tenesmus, Abdominal Pain, Constipation, Diarrhea, and Rectal Bleeding) were collected as a secondary endpoint. Severity of the events was graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 4.0. Grade 0 = None; 1=Mild; Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening. Adverse events were assessed during the course of RT and for 6 weeks following RT. The table below represents the worst grade for each patient for each type.
Two-sided chi-square tests will be used to compare each percentage variable between treatment arms for each event type."|During radiation therapy and up to 6 weeks post radiation therapy|Two patients in Arm I and one patient from Arm II were not included in the endpoint analyses due to cancellations and protocol violations. 42 patients from each arm started RT and were used for the analysis. 25 patients from Arm I and 29 patients from Arm II were evaluated after RT. Two patients from Arm 1 provided incomplete data.||Participants|||Count of Participants
826572|NCT01198145|Primary|Maximum Severity of Diarrhea Toxicity as Measured by the CTCAE v4.0 During and After Radiotherapy (RT)|"The primary endpoint for this study is the maximal severity of diarrhea toxicity. Severity of diarrhea was graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 4.0. Grade 0 = None; 1=Mild; Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening as measured by the CTCAE version 4.0. Assessments were recorded during the course of RT and for 6 weeks following RT. The table below represents the worst graded diarrhea for each patient.
A two-sided Wilcoxon rank-sum test will be used to test the equality of the distributions of maximum diarrhea severity grades between the two treatment arms."|During radiation therapy and up to 6 weeks post radiation therapy|Two patients in Arm I and one patient from Arm II were not included in the baseline analysis nor the endpoint analyses due to cancellations and protocol violations.||Participants|||Count of Participants
826573|NCT01198275|Primary|Probability of Maintenance of Sinus Rhythm at One-year Follow up.(Number of Patients Who Maintained Sinus Rhythm)|Sinus Rhythm maintenance means no Atrial Fibrillation recurrence at one-year follow up. Patients with successful electrical cardioversion (DCCV)underwent weekly clinical and electrocardiographic controls for the first three weeks following cardioversion. Subsequently, follow up visits with performance of clinical evaluation, ECG, and a 24-hour Holter monitoring were performed at 1, 3, 6 and 12 months after DCCV.|one year|||partecipants|||Number
826574|NCT01198275|Secondary|The Mean Time to a First Recurrence of AF and the Rate of AF Recurrence|The mean time to a first recurrence of AF; and the rate of AF recurrence at 1, 3 and 6 months.|1, 3 and 6 months||07/2011||||
826575|NCT01198327|Secondary|Mean Change in Retinal Thickness|Mean change in retinal thickness as measured by OCT (Optical Coherence Tomography).|24 mos from study baseline|||microns||Standard Deviation|Mean
826576|NCT01198327|Secondary|Mean Changes in Visual Acuity|Mean changes in visual acuity. Visual acuity is measured using standard ETDRS (Early Treatment Diabetic Retinopathy Study) charts which measure visual acuity in terms of letters( ETDRS Letters) read at a distance of 4 meters away from the chart. The ETDRS letters Score can be from 0 to 100, with 0 representing poor vision and 100 representing best vision.|24 mos from study baseline|||ETDRS letters||Standard Deviation|Mean
826577|NCT01198327|Primary|Incidence of Serious Adverse Events.|Record the serious adverse events, both ocular and non-ocular to gather long-term safety data.|24 mos|||number of serious adverse events|||Number
826578|NCT01198366|Secondary|Percentage of Subjects Converting From a Negative QuantiFERON Test (QFT) to Positive QFT After Vaccination|To evaluate the proportion of on-study QuantiFERON conversions from negative to positive in infants that received AERAS-402 compared to controls. A QFT value of on >= 0.35IU/mL was considered positive for this study.|up to 24 months post vaccination|Subjects who received at least one vaccination and had results at baseline and end of study.||% converting from QFT neg to pos|||Number
826579|NCT01198366|Secondary|Antigen-specific Antibody Response - Mean Optical Density (Mean OD)|To evaluate the immunogenicity of AERAS-402 compared to controls by ELISA Assay for Antigen-specific Antibody Response. Median responses of individual Mean OD (absorbance at 450nm) by study group is presented. Higher OD values suggests the presence of antibody to each of the Mtb antigens (Ag85A, Ag85B and TB10.4).|28 day post last vaccination|"Groups 1 and 4: Subjects who received both vaccinations as randomized (assays were not done for Ag85A and TB10.4).
Assays were not done for groups 2 and 3 for any antigen. Group 5: Subjects who received all three study vaccinations as randomized."||Optical Density||95% Confidence Interval|Median
826581|NCT01198366|Secondary|Percentage of Cells Expressing Various Cytokines Will be Measured by Intracellular Cytokine Staining (ICS) in All Subjects|To evaluate the immunogenicity of AERAS-402 compared to controls, flow cytometric ICS of CD4 and CD8 T cells producing any of three cytokines (IFN-γ, TNF-α, and/or IL-2) alone or in combination after stimulation with a peptide pool of mycobacterial peptides. Dimethylsulfoxide (DMSO) subtracted responses are presented.|28 days post last vaccination|Groups 1–4: Subjects who received both vaccinations as randomized. Group 5: Subjects who received all three study vaccinations as randomized.||percentage of Tcell response||95% Confidence Interval|Median
826582|NCT01198366|Primary|Adverse Events Collected Per Subject|Adverse Events (AEs) are recorded for 28 days post vaccination Serious Adverse Events (SAEs) are recorded for the entire study period to assess the safety profile|Up to 24 months post vaccination|Subjects who received at least one vaccination.||percentage of subjects with an AE|||Number
826583|NCT01198509|Secondary|Mean Units Change in DAS28 From Baseline to 6 Months|"DAS28 (disease activity score with 28 joint count). Possible score range: 0 to 10. This is a composite index calculated from 4 measures: two from a physician (28 tender joint count, 28 swollen joint count), one from the patient (patient global estimate of disease activity), and one laboratory biomarker (erythrocyte sedimentation rate or ESR). A score of 0 represents best possible health status (no apparent disease activity) and 10 represents worst possible.
The outcome is reported as mean change in DAS28 score from baseline to 6 months. The mean changes reported are negative values for downward change in score (i.e., improvement in health status)."|6 months|Please note that only the first 3 groups (RA doxycycline, RA vancomycin, and RA randomized to no treatment) were analyzed for change from baseline to six months (outcomes). Groups 4, 5 and 6 (RA cross-sectional, Psoriatic Arthritis, and Healthy Volunteers) were analyzed for baseline measures only in a cross-sectional comparison.||units on a scale||Full Range|Mean
826584|NCT01198509|Primary|Alteration of Microbiota, Alteration of T Cell Function/Activation|"Oral and intestinal microbiota, and T cell function and activation, will be assessed at baseline, and at 1, 2, 3, 4 and 5 months after baseline, to determine whether changes are associated with vancomycin treatment versus doxycycline treatment versus no treatment.
Results are reported as number of participants who experienced changes in oral/intestinal microbiota, T cell function/activation.
Methods/criteria to assess change in microbiota: change in relative abundance of microorganisms at genus and species level (as assessed high-throughput 16S rDNA sequencing).
Methods/criteria to assess change in T cell function/activation: change in percentage of inhibition of regulatory T cells as measured by interferon gamma levels in in-vitro assays."|6 months|Primary outcome only evaluated in first three groups of RA patients: 4 randomized to treatment with doxycycline; 10 randomized to treatment with vancomycin; 19 randomized to no treatment.||participants|||Number
826585|NCT01198548|Secondary|PFS of Patients Receiving Study Treatment|"The estimated distributions of PFS will be obtained using the product-limit based Kaplan-Meier method.
3 Year Survival Rate"|Defined as the time from the start of the study treatment until the date of progression or death from any cause, whichever comes first, assessed up to 3 years|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.|||||
826586|NCT01198548|Secondary|OS of Patients Receiving Study Treatment|The estimated distribution of OS will be obtained using the product-limit based Kaplan-Meier method.|Up to 3 years|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.|||||
826587|NCT01198548|Secondary|Toxicity Rates as Assessed by NCI CTCAE Version 4||Up to 30 days post-treatment|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.|||||
826588|NCT01198548|Secondary|RR of Patients Receiving Study Treatment||Up to 3 years|Trial terminated early. Too few patients to analyze.|||||
826589|NCT01198548|Primary|Rate of Sufficient Cholecalciferol||By week 16|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.|||||
826590|NCT01198548|Primary|Median PFS|The estimated distributions of PFS will be obtained using the product-limit based Kaplan-Meier method. The corresponding 95% confidence intervals for the estimated probability will be computed using the method proposed in Clopper and Pearson.|Up to 12 months|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.|||||
826591|NCT01198574|Primary|Status of Cellular Iron Deficiency|Cellular Iron deficiency status is also measured by serum transferrin receptor|at week 0, week 6 and week12|Per Protocol analysis||mg/L||Standard Deviation|Geometric Mean
826592|NCT01198574|Primary|Status of Tissue Iron Store|Tissue iron store was measured by serum ferritin|at week 0, week 6 and week12|Per Protocol analysis||µg/L||Standard Deviation|Geometric Mean
826593|NCT01198574|Primary|Haemoglobin Level|Haemoglobin level (g/L) measured by cyanmethaemoglobin method|at week 0, week 6 and week12|Per Protocol||g/L||Standard Deviation|Mean
826594|NCT01198600|Primary|Phase 3: Ocular Comfort, Lens Age 27 Days, End of Day|Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 27 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE (“I CANNOT tolerate the comfort of my eyes! I am in pain!”)and 100=VERY COMFORTABLE & FRESH (“Wow! My eyes feel incredible! I love this feeling.”)|Day 43|All enrolled and dispensed participants, Phase 3.||Units on a scale||Standard Deviation|Mean
826595|NCT01198600|Primary|Phase 3: Ocular Comfort, Lens Age 27 Days, Hour 10|Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 27 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE (“I CANNOT tolerate the comfort of my eyes! I am in pain!”)and 100=VERY COMFORTABLE & FRESH (“Wow! My eyes feel incredible! I love this feeling.”)|Day 43|All enrolled and dispensed participants, Phase 3.||Units on a scale||Standard Deviation|Mean
826596|NCT01198600|Primary|Phase 3: Ocular Comfort, Lens Age 27 Days, Hour 1|Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 27 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE (“I CANNOT tolerate the comfort of my eyes! I am in pain!”)and 100=VERY COMFORTABLE & FRESH (“Wow! My eyes feel incredible! I love this feeling.”)|Day 43|All enrolled and dispensed participants, Phase 3.||Units on a scale||Standard Deviation|Mean
826770|NCT01193114|Secondary|BDI Depression Score|Beck Depression Inventory - II (BDI - II) Range from 0 (no depression) to 63 (severe depression)|9 months post-baseline measure|The analysis was conducted with all of the collected data. Discrepancies in number of participants between the Participant Flow Module and the analysis are due to missing data.||units on a scale||Standard Deviation|Mean
826598|NCT01198600|Primary|Phase 3: Ocular Comfort, Lens Age 14 Days, Hour 10|Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 14 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE (“I CANNOT tolerate the comfort of my eyes! I am in pain!”)and 100=VERY COMFORTABLE & FRESH (“Wow! My eyes feel incredible! I love this feeling.”)|Day 15|All enrolled and dispensed participants, Phase 3.||Units on a scale||Standard Deviation|Mean
826599|NCT01198600|Primary|Phase 3: Ocular Comfort, Lens Age 14 Days, Hour 1|Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 14 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE (“I CANNOT tolerate the comfort of my eyes! I am in pain!”)and 100=VERY COMFORTABLE & FRESH (“Wow! My eyes feel incredible! I love this feeling.”)|Day 15|All enrolled and dispensed participants, Phase 3.||Units on a scale||Standard Deviation|Mean
826600|NCT01198600|Primary|Phase 3: Ocular Comfort, Lens Age 1 Day, End of Day|Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 1 day. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE (“I CANNOT tolerate the comfort of my eyes! I am in pain!”)and 100=VERY COMFORTABLE & FRESH (“Wow! My eyes feel incredible! I love this feeling.”)|Day 1|All enrolled and dispensed participants, Phase 3.||Units on a scale||Standard Deviation|Mean
826601|NCT01198600|Primary|Phase 3: Ocular Comfort, Lens Age 1 Day, Hour 10|Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 1 day. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE (“I CANNOT tolerate the comfort of my eyes! I am in pain!”)and 100=VERY COMFORTABLE & FRESH (“Wow! My eyes feel incredible! I love this feeling.”)|Day 1|All enrolled and dispensed participants, Phase 3.||Units on a scale||Standard Deviation|Mean
826602|NCT01198600|Primary|Phase 3: Ocular Comfort, Lens Age 1 Day, Hour 1|Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 1 day. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE (“I CANNOT tolerate the comfort of my eyes! I am in pain!”)and 100=VERY COMFORTABLE & FRESH (“Wow! My eyes feel incredible! I love this feeling.”)|Day 1|All enrolled and dispensed participants, Phase 3.||Units on a scale||Standard Deviation|Mean
826603|NCT01198691|Secondary|Patient Satisfaction|"Patients will be given a survey at their 6 week post-op visit to assess their satisfaction with the appearance of their scar. The survey asked whether patients strongly agree, agree, disagree, or strongly disagree with the statement, I am satisfied with the overall appearance of my incision. Those who responsed agree or strongly agree were said to be satisfied with the appearance and the outcome is reported as number of participants who were satisfied."|Patient satisfaction will be assessed 6 weeks later at their post-op visit|||participants|||Number
826604|NCT01198691|Secondary|Patient Satisfaction|"Patients will be given a survey prior to being discharged to assess their satisfaction with the appearance of their scar. The survey asked whether patients strongly agree, agree, disagree, or strongly disagree with the statement, I am satisfied with the overall appearance of my incision. Those who responsed agree or strongly agree were said to be satisfied with the appearance and the outcome is reported as number of participants who were satisfied."|This will be assessed 3 day after the patient's C-section before they are discharged from the hospital|||participants|||Number
826605|NCT01198691|Primary|Post Operative Pain (3 Days Post-op)|Post operative pain at the time of discharge will be measured using the Visual Analogue Scale (VAS). The scale has a minimum score of 0 representing no pain and a maximum score of 10 representing the worst possible pain.|1 Year|||units on a scale||Standard Deviation|Mean
826606|NCT01198691|Primary|Post Operative Pain|Post operative pain at post operative day #1 will be measured using the Visual Analogue Scale (VAS). The scale has a minimum score of 0 representing no pain and a maximum score of 10 representing the worst possible pain.|1 Year|||units on a scale||Standard Error|Mean
826607|NCT01198756|Secondary|Number of Subjects With Any and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s)= Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination.|During the entire study period (from Day 0 to Day 180)|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
826608|NCT01198756|Secondary|Number of Subjects With Any and Related Medically-attended Adverse Events (MAEs) After Vaccination|Medically-attended adverse events (MAEs) were non-serious and serious events leading to an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits. If a medically-attended adverse event was leading to hospitalization (or met any other criterion for serious adverse event (SAE)), it was reported as SAE. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.Relationship to vaccination was not assessed for MAEs.|During the entire study period (from Day 0 to Day 180)|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
826609|NCT01198756|Secondary|Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) After Vaccination|"Potential immune-mediated diseases (pIMDs) are a subset of adverse events that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.
Any pIMD(s) = Occurrence of any pIMD(s) regardless of intensity grade or relation to vaccination. Related pIMD(s) = pIMD assessed by the investigator as causally related to the study vaccination."|During the entire study period (from Day 0 to Day 180)|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
826675|NCT01199744|Secondary|Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Who Were Also Taking Concomitant Medications|Concomitant medications are defined as drugs used during the administration of Relenza.|5 months (November 2009 to March 2010)|All participants who visited the sentinel 26 centers from the date of the contract to 31st March 2010 and were prescribed Relenza for the purpose of either treatment or prophylaxis of influenza||participants|||Number
826610|NCT01198756|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any unsolicited AE(s) = Occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 unsolicited AE = Occurrence of any unsolicited AE that prevented normal activities. Related unsolicited AE(s) = Occurrence of an unsolicited AE assessed by the investigator to be causally related to vaccination.|During the 28-day follow-up period (Day 0-27) after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
826611|NCT01198756|Secondary|Number of Days With Fever in All Subjects Regardless of Their Age After Vaccination|Duration for fever was assessed via tabulation of the number of days with local symptoms of fever (axillary temperature ≥ 38°C) after vaccination with Dose 1 and Dose 2, respectively.|During the 7-day follow-up period (Days 0-6) after vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with vaccine administration documented, solely on subjects with symptom sheet completed for the reported specific symptom.||Days||Inter-Quartile Range|Median
826612|NCT01198756|Secondary|Number of Days With Solicited General Symptoms After Vaccination in Subjects 5 Years of Age and Above|Duration was assessed via tabulation of the number of days with local symptoms of any grade after vaccination with Dose 1 and Dose 2, respectively. Solicited general symptoms assessed for duration in subjects 5 years of age and above were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches and shivering.|During the 7-day follow-up period (Days 0-6) after vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with vaccine administration documented, solely on subjects with symptom sheet completed for the reported specific symptom.||Days||Inter-Quartile Range|Median
826613|NCT01198756|Secondary|Number of Days With Solicited General Symptoms After Vaccination in Subjects Below 5 Years of Age|Duration was assessed via tabulation of the number of days with local symptoms of any grade after vaccination with Dose 1 and Dose 2, respectively. Solicited general symptoms assessed for duration in subjects below 5 years of age were drowsiness, irritability and loss of appetite.|During the 7-day follow-up period (Days 0-6) after vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with vaccine administration documented, solely on subjects with symptom sheet completed for the reported specific symptom.||Days||Inter-Quartile Range|Median
826614|NCT01198756|Secondary|Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches, shivering and temperature. Any = Incidence of a particular symptom regardless of intensity grade or relationship to vaccination. Any temperature = axillary temperature ≥ 38.0 °C. Grade 3 temperature = axillary temperature ≥ 39.0°C. Grade 3 symptom = Symptom that prevented normal activity. Related = A general symptom assessed by the investigator as causally related to vaccination.|During the 7-day follow-up period (Days 0-6) after vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with vaccine administration documented, solely on subjects with symptom sheet completed for the reported specific symptom.||subjects|||Number
826615|NCT01198756|Secondary|Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms|Symptoms assessed were drowsiness, irritability, loss of appetite and temperature. Any = Incidence of a particular symptom regardless of intensity grade or relationship to vaccination. Any temperature = Axillary temperature ≥ 38.0 degrees Celsius (°C). Grade 3 temperature = Axillary temperature ≥ 39.0°C. Grade 3 irritability = Crying that could not be comforted/ preventing normal activity. Grade 3 drowsiness = Drowsiness preventing normal activity. Grade 3 loss of appetite = Not eating at all. Related = A general symptom assessed by the investigator as causally related to vaccination.|During the 7-day follow-up period (Days 0-6) after vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with vaccine administration documented, solely on subjects with symptom sheet completed for the reported specific symptom.||subjects|||Number
826616|NCT01198756|Secondary|Number of Days With Solicited Local Symptoms After Vaccination|Duration was assessed via tabulation of the number of days with local symptoms of any grade after vaccination with Dose 1 and Dose 2 respectively. Solicited local symptoms assessed for duration were pain, redness and swelling.|During the 7-day follow-up period (Days 0-6) after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.||Days||Inter-Quartile Range|Median
826617|NCT01198756|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity grade. Grade 3 pain for subjects < 5 years of age = Cried when limb was moved/spontaneously painful; Grade 3 pain for subjects ≥ 5 years of age = Significant pain at rest, pain that preventeded normal everyday activities. Grade 3 redness and swelling were defined as redness/swelling above 100 millimeters (mm).|During the 7-day follow-up period (Days 0-6) after vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with vaccine administration documented, solely on subjects with symptom sheet completed for the reported specific symptom.||subjects|||Number
826618|NCT01198756|Secondary|Seroconversion Factor for Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease - By Age Strata|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0 (i.e. the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer). The 4 assessed influenza strains were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains. Subjects were assessed according to 3 age categories, 3-8 years, 9-17 years and 6-35 months.|At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, inclusive of all evaluable and eligible subjects with immunogenicity results available for antibodies against at least one study vaccine component after vaccination, solely on subjects with both pre- and post-vaccination immunogenicity results available.||fold increase||95% Confidence Interval|Geometric Mean
826619|NCT01198756|Secondary|Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition titer ≥ 1:40. The 4 assessed influenza strains were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 flu strains. Subjects were assessed according to 3 age categories, 3-8 years, 9-17 years and 6-35 months.|At Day 0 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable and eligible subjects for whom data concerning immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||subjects|||Number
826620|NCT01198756|Secondary|Number of Subjects Seroconverted Against 4 Strains of Influenza Disease - By Age Strata|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The vaccine strains assessed were A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains. Subjects were assessed according to 3 age categories, 3-8 years, 9-17 years and 6-35 months.|At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, inclusive of all evaluable and eligible subjects with immunogenicity results available for antibodies against at least one study vaccine component after vaccination, solely on subjects with both pre- and post-vaccination immunogenicity results available.||subjects|||Number
826621|NCT01198756|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata|Titers are presented as geometric mean titers (GMTs). The reference cut-off value was the seropositivity cut-off of 1:10. Antibodies assessed were antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains. Subjects were assessed according to 3 age categories, 3-8 years, 9-17 years and 6-35 months.|At Day 0 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable and eligible subjects for whom data concerning immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||titer||95% Confidence Interval|Geometric Mean
826622|NCT01198756|Secondary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination (at Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects (POST)) compared to Day 0 (i.e. the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer). The 4 assessed influenza strains were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains|At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, inclusive of all evaluable and eligible subjects with immunogenicity results available for antibodies against at least one study vaccine component after vaccination, solely on subjects with both pre- and post-vaccination immunogenicity results available.||fold increase||95% Confidence Interval|Geometric Mean
826623|NCT01198756|Secondary|Number of Subjects Seroprotected Against 4 Strains of Influenza Disease|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition titer ≥ 1:40. The 4 assessed influenza strains were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 flu strains.|At Day 0 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable and eligible subjects for whom data concerning immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||subjects|||Number
826624|NCT01198756|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The reference cut-off value was the seropositivity cut-off of 1:10. Antibodies assessed were antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains.|At Day 0 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable and eligible subjects for whom data concerning immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||titer||95% Confidence Interval|Geometric Mean
826625|NCT01198756|Primary|Number of Subjects Seroconverted Against 4 Strains of Influenza Disease|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The vaccine strains assessed were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains.|At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, inclusive of all evaluable and eligible subjects with immunogenicity results available for antibodies against at least one study vaccine component after vaccination, solely on subjects with both pre- and post-vaccination immunogenicity results available.||subjects|||Number
826676|NCT01199744|Secondary|Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Who Were Vaccinated for Influenza||5 months (November 2009 to March 2010)|All participants who visited the sentinel 26 centers from the date of the contract to 31st March 2010 and were prescribed Relenza for the purpose of either treatment or prophylaxis of influenza||participants|||Number
826626|NCT01198756|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The reference cut-off value was the seropositivity cut-off of 1:10. Antibodies assessed were antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains.|At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable and eligible subjects for whom data concerning immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||titer||95% Confidence Interval|Geometric Mean
826627|NCT01198769|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|During the entire study period (from Dose 1 at Day 0 up to Month 4)|The Total vaccinated cohort included all subjects with at least one vaccine administration documented.||Subjects|||Number
826628|NCT01198769|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs).|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within the 31-day (Days 0-30) follow-up period after vaccination|The Total vaccinated cohort included all subjects with at least one vaccine administration documented.||Subjects|||Number
826629|NCT01198769|Secondary|Number of Subjects With Rotavirus (RV) Present in the Gastroenteritis (GE) Stool Sample.|"RV was not identified in the one GE stool sample collected in the study. Two subjects reported GE episode between vaccination Dose 1 and before vaccination Dose 2. For one of them, GE stool sample was not collected and for the other subject no RV was identified in the GE stool sample.
GE symptoms were defined as diarrhoea with or without vomiting. A GE stool sample was collected as soon as possible after the illness began by the parent/guardian of the subject. Presence of RV antigen was detected by Enzyme-linked immunosorbent assay (ELISA)."|From Day 0 (first vaccine dose) to study Month 4 (2 months post-Dose 2)|The Total vaccinated cohort included all subjects with at least one vaccine administration documented.||Subjects|||Number
826630|NCT01198769|Secondary|Number of Subjects Reporting Solicited General Symptoms.|Solicited general symptoms assessed were cough, diarrhoea, irritability, loss of appetite, temperature (any temperature was defined as a tympanic on rectal setting temperature ≥ 38.0 degrees Celsius) and vomiting.|During the 8-day (Days 0-7) post-vaccination period|The Total vaccinated cohort included all subjects with at least one vaccine administration documented.||Subjects|||Number
826631|NCT01198769|Secondary|Serum Anti-rotavirus IgA Antibody Concentrations.|Concentrations were expressed as geometric mean antibody concentration in units per millilitre (U/mL), calculated on all subjects.|2 months post-Dose 2 (at study Month 4)|The According-To-Protocol cohort for immunogenicity included subjects who received Hepatitis B immunoglobulin after birth, who were seronegative for serum anti-RV IgA antibody at Day 0, who complied with vaccination schedule for the Rotarix vaccine, who had no RV other than the vaccine strain in gastroenteritis stool sample up to Month 4.||U/mL||95% Confidence Interval|Geometric Mean
826632|NCT01198769|Primary|Number of Seroconverted Subjects for Serum Anti-rotavirus Immunoglobulin A (IgA) Antibody.|Seroconversion is defined as the appearance of IgA antibody concentration equal to or above (≥) 20 Units per millilitre (U/mL) in the serum of subjects who were seronegative before vaccination. A seronegative subject is a subject with anti-rotavirus IgA antibody concentration below (<) 20 U/mL.|2 months post-Dose 2 (at study Month 4)|The According-To-Protocol cohort for immunogenicity included subjects who received Hepatitis B immunoglobulin after birth, who were seronegative for serum anti-RV IgA antibody at Day 0, who complied with vaccination schedule for the Rotarix vaccine, who had no RV other than the vaccine strain in gastroenteritis stool sample up to Month 4.||Subjects|||Number
826633|NCT01198795|Primary|Patients With Any Treatment Emergent Adverse Events (TEAEs)|The number of patients who experienced one or more TEAE during the 24-week open-label treatment period or the 2-week down-taper period,|From Baseline (Week 0) to Week 26|||participants|||Number
826634|NCT01198873|Secondary|Changes From Baseline in Left Ventricular Function|"left ventricular (LV) function was assessed at baseline and after 12 months treatment using 2-D echocardiography and interpreted blindly via a central Echocardiography Core Lab.
Participants who discontinued after completing at least 3 months of treatment were assessed after last study drug intake and data were included in the analysis."|baseline (before randomization) and post-baseline (after 3-12 months of treatment)|||centimeters/second||Standard Deviation|Mean
826635|NCT01198873|Secondary|Changes From Baseline in Left Ventricular Ejection Fraction (LVEF)|"Left Ventricular Ejection Fraction (LVEF) was assessed at baseline and after 12 months treatment using 2-D echocardiography and interpreted blindly via a central Echocardiography Core Lab.
Participants who discontinued after completing at least 3 months of treatment were assessed after last drug intake and data were included in the analysis."|baseline (before randomization) and post-baseline (after 3-12 months of treatment)|Modified intent-to-treat population as previously defined||percentage of blood pumped out||Standard Deviation|Mean
826636|NCT01198873|Secondary|Changes From Baseline in Left Atrial Dimension|"Maximal left atrial diameter in the anteroposterior dimension was assessed at baseline and after 12 months treatment using 2-D echocardiography and interpreted blindly via a central Echocardiography Core Lab.
Participants who discontinued after completing at least 3 months of treatment were assessed after last drug intake and data were included in the analysis."|baseline (before randomization) and post-baseline (after 3-12 months of treatment)|Modified intent-to-treat population as previously defined||centimeters||Standard Deviation|Mean
826637|NCT01198873|Secondary|Changes From Baseline in Left Atrial Function|"left atrial (LA) function was assessed at baseline and after 12 months treatment using 2-D echocardiography and interpreted blindly via a central Echocardiography Core Lab.
Participants who discontinued after completing at least 3 months of treatment were assessed after last study drug intake and data were included in the analysis."|baseline (before randomization) and post-baseline (after 3-12 months of treatment)|Modified intent-to-treat population as previously defined||mililiters||Standard Deviation|Mean
826638|NCT01198873|Primary|Change From Baseline in Left Atrial Volume Index (LAVi)|"Left Atrial Volume index (LAVi) was assessed at baseline and after 12 months treatment using 2-D echocardiography and interpreted blindly via a central Echocardiography Core Lab.
Participants who discontinued after completing at least 3 months of treatment were assessed after last study drug intake and data were included in the analysis."|baseline (before randomization) and post-baseline (after 3-12 months of treatment)|"The analysis included all randomized and treated participants with at least one post-baseline echocardiographic assessment. Participants were included in the treatment group to which they were randomized (Modified Intent-to-treat analysis).
The quality of the post-baseline echocardiography was inadequate for determining LAVi in one participant."||mililiters/m2||Standard Deviation|Mean
826639|NCT01198977|Other Pre-specified|Physical Activity (Behavioral Target)|First item of the Godin Leisure-Time Exercise Questionnaire (GLTEQ). GLTEQ asks participants to indicated the number of days per week they engaged in strenuous (e.g., running), moderate (e.g., easy bicycling), and mild (e.g., easy walking) exercise activities for periods of 15 min or more. Total weekly frequency is then calculated using an algorithm that multiplies the frequency of activities by 9 (strenuous), 5 (moderate), or 3 (mild) metabolic equivalents and sums each to produce a total level of physical activity in MET/min per week.|baseline, 3 months, 6 months|Veterans with MS from Veterans Affairs (VA) Puget Sound Health Care System and civilians with MS from the greater Puget Sound area. Note: Telephone Counseling Group: 1=lost to follow-up, so analyzed 30 participants instead of 31.||units on a scale||Standard Error|Mean
826640|NCT01198977|Secondary|Depression|"Depression Module of the Patient Health Questionnaire (PHQ-9). 9-item self-report instrument designed to identify depressive symptoms consistent with criteria for major depressive episode in the Diagnostic and Statistical Manual for Mental Disorders, 4th Edition. Each item is rated over the last 2 weeks: 0 (not at all), 1 (several days), 2 (more than half the days), or 3 (nearly every day).
Total Score for 9 items = 27."|baseline, 3 months, 6 months|Veterans with MS from Veterans Affairs (VA) Puget Sound Health Care System and civilians with MS from the greater Puget Sound area. Note: Telephone Counseling Group: 1=lost to follow-up, so analyzed 30 participants instead of 31.||units on a scale||Standard Error|Mean
826641|NCT01198977|Primary|Fatigue|Modified Fatigue Inventory Scale (MFIS) at baseline, 3-month, 6-month MFIS consisted of 21 items, ranging from 0 (never) to 4 (almost always). The total score was 0 to 84.|baseline, 3 months, 6 months|Veterans with MS from Veterans Affairs (VA) Puget Sound Health Care System and civilians with MS from the greater Puget Sound area. Note: Telephone Counseling Group: 1=lost to follow-up, so analyzed 30 participants instead of 31.||units on a scale||Standard Error|Mean
826642|NCT01199016|Other Pre-specified|Percentage of Nasopharyngeal/Oropharyngeal (NP/OP) Samples With Positive Results for Streptococcus Pneumoniae Serotypes Other Than 1, 3, 5, 6A, 7F, or 19A in Healthy Participants|Total percentage of MEF samples that were tested positive for Streptococcus pneumoniae serotypes other than those included in Prevnar 13 (1, 3, 5, 6A, 7F, or 19A) have been reported. NP/OP samples were collected from participants at all healthy visits as well as AOM visits.|Baseline up to Month 36|NP/OP healthy population included all participants with an NP/OP swab collection at a healthy visit. In this analysis, 'Number of NP/OP samples analyzed' indicates those samples that tested positive for Streptococcus pneumoniae.||percentage of NP/OP samples|NP/OP Samples||Number
826643|NCT01199016|Other Pre-specified|Percentage of Middle Ear Fluid (MEF) Samples With Positive Results for Streptococcus Pneumoniae Serotypes Other Than 1, 3, 5, 6A, 7F, or 19A in Participants With Acute Otitis Media (AOM)|MEF samples were obtained from participants who presented with an episode of AOM as defined by clinical criteria. Total percentage of MEF samples that were tested positive for Streptococcus pneumoniae serotypes other than those included in Prevnar 13 (1, 3, 5, 6A, 7F, or 19A) have been reported.|Baseline up to Month 36|MEF AOM population included all participants with at least 1 MEF sample from an episode of AOM. In this analysis, 'Number of MEF samples analyzed' indicates those samples that tested positive for Streptococcus pneumoniae.||percentage of MEF samples|MEF Samples||Number
826644|NCT01199016|Other Pre-specified|Percentage of Nasopharyngeal/Oropharyngeal (NP/OP) Samples With Positive Results for Streptococcus Pneumoniae Serotypes 1, 3, 5, 6A, 7F, or 19A in Healthy Participants|Total percentage of NP/OP samples that were tested positive for any of the 6 additional serotypes included in Prevnar 13 (1, 3, 5, 6A, 7F, or 19A) have been reported. NP/OP samples were collected from participants at all healthy visits as well as AOM visits.|Baseline up to Month 36|NP/OP healthy population included all participants with an NP/OP swab collection at a healthy visit. In this analysis, 'Number of NP/OP samples analyzed' indicates those samples that tested positive for Streptococcus pneumoniae serotypes 1, 3, 5, 6A, 7F, or 19A.||percentage of NP/OP samples|NP/OP Samples||Number
826645|NCT01199016|Primary|Percentage of Middle Ear Fluid (MEF) Samples With Positive Results for Streptococcus Pneumoniae Serotypes 1, 3, 5, 6A, 7F, or 19A in Participants With Acute Otitis Media (AOM)|MEF samples were obtained from participants who presented with an episode of AOM as defined by clinical criteria. Total percentage of MEF samples that were tested positive for any of the 6 additional serotypes included in Prevnar 13 (1, 3, 5, 6A, 7F, or 19A) have been reported.|Baseline up to Month 36|MEF AOM population included all participants with at least 1 MEF sample from an episode of AOM. In this analysis, 'Number of MEF samples analyzed' indicates those samples that tested positive for Streptococcus pneumoniae serotypes 1, 3, 5, 6A, 7F, or 19A.||percentage of MEF samples|MEF Samples||Number
826646|NCT01199042|Secondary|Average Therapy Pressure Values|"To compare BiPAP autoSV Advanced therapy pressure values (Encore Pro Software) from the first 7 days of BiPAP autoSV Advanced at home treatment to the last 7 days of at home treatment to determine if pressure requirements change over time.
This analysis compares the average pressure support of the first week compared to the average pressure support to the final week."|3 months|26 participants completed the 3-month home follow-up.||cm/H2O||Standard Deviation|Mean
826647|NCT01199042|Secondary|Breathing Event Indexes|"To determine if there are changes in breathing event indexes (Encore Pro Software) from the first 7 days of BiPAP autoSV Advanced at home treatment to the last 7 days of at home treatment to assess therapy efficacy.
Values were determined by taking the average of the first 7 days of treatment and comparing them to the average of the last 7 days of treatment."|from the first 7 days of BiPAP autoSV Advanced at home treatment to the last 7 days of at home treatment|26 participants completed the 3-month home follow-up.||Apnea-Hypopnea events per hour||Standard Deviation|Mean
829786|NCT01230307|Secondary|Exercise Capacity Measured by 6 Minute Walk Test||6 months|Because enrollment was less than 30% of original goal (6 vs 4 patients) and therefore would not have scientific validity and no conclusions could be determined, this outcome was not analyzed.|||||
826648|NCT01199042|Secondary|Epworth Sleepiness Scale|"To determine if there are changes in subjective sleepiness on the Epworth Sleepiness Scale (ESS) between Baseline (Visit 1) and 3 months (Visit 6). The ESS is an 8 question survey that determines sleepiness, each question is rated as a 0-3 will the total score ranging from 0-24.
Interpretation:
Score 0-7: Unlikely that there is abnormal sleep Score 8-9: Average amount of daytime sleepiness Score 10-15: Possible excessive sleepiness depending on the situation. Patient may want to consider seeking medical attention.
Score 16-24: Excessive sleepiness and patient should consider seeking medical attention
A decrease in the score indicates improvements in a patients overall sleepiness. An increase in the score indicates increased sleepiness."|3 months|26 participants completed the 3-month home follow-up.||units on a scale||Standard Deviation|Mean
826649|NCT01199042|Primary|Apnea/Hypopnea Index (AHI)|To compare the AHI between the diagnostic CPAP titration and BiPAP autoSV Advanced PSG nights.|During a single night of polysomnography lasting up to 8 hours.|||Apnea-Hypopnea events per hour||Standard Deviation|Mean
826650|NCT01199237|Secondary|Time From Anesthetic Discontinuation to First Ability to Swallow|At 2 minutes after first response to command (T1), the patient was asked to swallow 20 mL of water from a paper cup, and an observer blinded to anesthetic assignment assessed the ability to swallow based on transit of water to the posterior pharynx (absence of pooling or drooling) and absence of cough or gag (indicating misdirection of the water bolus into the laryngeal inlet). This test was repeated at 6, 14, 22, 30 and 60 minutes after the time of first response to command.|up to 60 minutes after T1|||Seconds||Full Range|Mean
826651|NCT01199237|Secondary|Nausea and Vomiting|Patients were asked to rate their experience of nausea and vomiting on a 0-10 verbal analog scale, with 0 being absence and 10 being the worst imaginable|60 minutes after T1|Only patients able to respond at time of assessment||units on a scale||Full Range|Mean
826652|NCT01199237|Secondary|Nausea and Vomiting|Patients were asked to rate their experience of nausea and vomiting on a 0-10 verbal analog scale, with 0 being absence and 10 being the worst imaginable|30 minutes after T1|Only participants able to respond at time of assessment||units on a scale||Full Range|Mean
826653|NCT01199237|Secondary|Time From Potent Inhaled Anesthetic Discontinuation to First Response to Command (T1)|"At the conclusion of surgery, after the patient's potent inhaled anesthetic was discontinued, the commands open your eyes and squeeze my hand were given at 30-second intervals. The time at which patient first appropriately response to both commands was noted as T1."|Up to 1 hour post-operative|||seconds||Full Range|Mean
826654|NCT01199237|Primary|Recovery of Ability to Swallow After Neostigmine/Glycopyrrolate Antagonism of Rocuronium Paralysis.|The patient is judged by the primary anesthetist to be awake at time T1. At 2 minutes after T1, the patient was asked to swallow 20mL of water from a paper cup, and a blinded observer judged the ability to swallow based on transit of water to the posterior pharynx (absence of pooling or drooling) and absence of cough or gag.|At 2 minutes after response to command (T1).|Only participants judged by the clinician as able to take the test (n=57)||participants|||Number
826655|NCT01199471|Secondary|Time to Extubation of Patients|The time to extubation of patients was measured from cessation of anesthesia administration to tracheal extubation of the patient.|Every minute after cessation of anesthesia until the patient was extubated|All available data were included in the analysis.||minutes||Standard Deviation|Mean
826656|NCT01199471|Secondary|Time to Eye Opening of Patients|Time to eye opening of patients was measured by the time from cessation of anesthesia administration to opening of the patients' eyes. After cessation of anesthesia, the investigators lightly tapped on the patients forehead or shoulder and asked the patients to open their eyes. This process was repeated about every minute until the patients opened their eyes.|Every minute after cessation of anesthesia until the patient opened his/her eyes|All available data were included in the analysis.||minutes||Standard Deviation|Mean
826657|NCT01199471|Secondary|Time to Intubation of Patients|The time to intubation of the patients was measured from the commencement of administration of anesthesia to intubation of each patient.|Up to 10 minutes|All available data were included in the analysis.||minutes||Standard Deviation|Mean
826658|NCT01199471|Secondary|Time to Loss of Consciousness of Patients Administered Anesthesia|The time to loss of consciousness was measured from commencement of administration of anesthesia to the patient's loss of consciousness (no response to command).|Up to 10 minutes|All available data were included in the analysis.||minutes||Standard Deviation|Mean
826659|NCT01199471|Primary|Patient Satisfaction With the Anesthesia Recorded at the End of the Operation Using a Numeric Analog Scale (NAS)|Patient satisfaction with the anesthesia recorded at the end of the operation within 24 hours using a numeric analog scale (NAS) from 0 (not satisfied at all) to 10 (completely satisfied) are summarized.|Within 24 hours|All available data were included in the analysis.||units on a scale||Standard Deviation|Mean
826660|NCT01199471|Primary|Anesthesiologist Satisfaction With the Anesthesia Recorded at the End of the Operation Using a Numeric Analog Scale (NAS)|Anesthesiologist satisfaction with the anesthesia administered to each patient during surgery was recorded at the end of the operation using a Numeric Analog Scale (NAS) from 0 (not satisfied at all) to 10 (completely satisfied) are summarized.|Within 24 hours|400 participating anesthesiologists evaluated their satisfaction with anesthesia (sevoflurane) administered to patients during surgery. All available data for 3,993 patients are included and summarized.||units on a scale||Standard Deviation|Mean
826661|NCT01199601|Secondary|Completion of 9 Month Measles-mumps-rubella Vaccination on Time.|Assess whether patients randomized to the intervention were more likely to have children receiving the measles-mumps-rubella vaccination at 9 months of age after receiving concentrated postpartum counseling compared to women receiving standard of care.|12 months|||participants|||Number
826662|NCT01199601|Secondary|Correct Breastfeeding Practices to 1 Year|Assess whether patients randomized to the intervention exhibit correct breastfeeding practices (a composite variable in which exclusive breastfeeding occurs to 6 months and continued complementary breastfeeding continues to 12 months) after receiving concentrated postpartum counseling compared to women receiving standard of care.|12 months|||participants|||Number
826663|NCT01199601|Primary|Utilization of Postpartum Contraception|Determine whether the re-training and assignment of healthcare providers dedicated to intrapartum rapid testing and intensive post-partum counseling will positively impact postpartum contraceptive use as compared to any counseling provided by existing health providers for these services among women delivering in public health maternity hospitals in Kabul, Afghanistan.|12 months|Participants included in analysis were those completing the 6 and 12 month follow-up visits.||participants|||Number
826664|NCT01199705|Secondary|Rate of Mild, Moderate, or Severe Local Reactions|"In addition to the standard MedDRA System Organ Class (SOC) AE assignments, the category of 'local reactions' was defined to provide the possibility for a combined analysis of local reactions and included AEs of: infusion site discomfort, infusion site erythema, infusion site haemorrhage, infusion site induration, infusion site inflammation, infusion site pain, infusion site pruritus, infusion site swelling, injection site erythema, injection site extravasation, injection site induration, injection site irritation, injection site pain, injection site pruritus, injection site swelling, and puncture site reaction.
Mild AE: Symptoms are easily tolerated and there is no interference with daily activities; Moderate AE: Discomfort enough to cause some interference with daily activities; Severe AE: Incapacitating with inability to work or do usual activity."|For the duration of the study, up to 36 weeks|The SDS comprised all subjects treated with the study drug.||AEs per infusion|Participants||Number
826665|NCT01199705|Secondary|Rate of All Adverse Events by Relatedness and Seriousness|The rate of adverse events (AEs) was the number of treatment-emergent AEs over the number of infusions administered. At least possibly related AEs included possibly related AEs, probably related AEs, and related AEs.|For the duration of the study, up to 36 weeks|The safety data set (SDS) comprised all subjects treated with the study drug.||AEs per infusion|Participants||Number
826666|NCT01199705|Secondary|Duration of Use of Antibiotics for Infection Prophylaxis and Treatment|Median number of days of use of antibiotics for infection prophylaxis and/or treatment, presented by study period: IVIG treatment (up to 12 weeks), SCIG IgPro20 treatment (wash-in/wash-out; 12 weeks), and SCIG IgPro20 treatment (efficacy; 12 weeks).|Up to 36 weeks|||Days||Full Range|Median
826667|NCT01199705|Secondary|Number of Days of Hospitalization Due to Infections by Study Period|Median number of days of hospitalization due to infections, presented by study period: IVIG treatment (up to 12 weeks), SCIG IgPro20 treatment (wash-in/wash-out; 12 weeks), and SCIG IgPro20 treatment (efficacy; 12 weeks).|Up to 36 weeks|||Days||Full Range|Median
826668|NCT01199705|Other Pre-specified|Annualized Rate of Serious Bacterial Infections (SBIs), FAS Population|"The annualized rate was based on the total number of SBIs and the total number of subject study days for all subjects in the specified study periods (listed below) and analysis population and adjusted to 365 days.
Study periods:
IVIG treatment (up to 12 weeks)
SCIG IgPro20 treatment (wash-in/wash-out; 12 weeks)
SCIG IgPro20 treatment (efficacy; 12 weeks)"|Up to 36 weeks|The FAS comprised all subjects treated with IgPro20 during the efficacy period who had the disease under study.||SBIs per subject year|Participants||Number
826669|NCT01199705|Secondary|Number of Days Out of Work/School/Kindergarten/Day Care or Unable to Perform Normal Daily Activities Due to Infections by Study Period|Median number of days out of work/school/kindergarten/day care or unable to perform normal daily activities due to infections, presented by study period: IVIG treatment (up to 12 weeks), SCIG IgPro20 treatment (wash-in/wash-out; 12 weeks), and SCIG IgPro20 treatment (efficacy; 12 weeks).|Up to 36 weeks|||Days||Full Range|Median
826670|NCT01199705|Other Pre-specified|Annualized Rate of Serious Bacterial Infections (SBIs), PPS Population|"The annualized rate was based on the total number of SBIs and the total number of subject study days for all subjects in the specified study periods (listed below) and analysis population and adjusted to 365 days.
Study periods:
IVIG treatment (up to 12 weeks)
SCIG IgPro20 treatment (wash-in/wash-out; 12 weeks)
SCIG IgPro20 treatment (efficacy; 12 weeks)"|Up to 36 weeks|The PPS comprised all subjects with the disease under study who fulfilled the protocol-specified criteria for a) immunoglobulin treatment prior to and during the study, b) availability of evaluable serum IgG levels, and c) dose stability.||SBIs per subject year|Participants||Number
826671|NCT01199705|Secondary|Rate of Infection Episodes (Serious and Non-serious) by Study Period, FAS Population|"The annualized rate of infection episodes (serious and non-serious) was based on the total number of infection episodes and the total number of subject study days for all subjects in the specified study periods (listed below) and analysis population and adjusted to 365 days.
Study periods:
IVIG treatment (up to 12 weeks)
SCIG IgPro20 treatment (wash-in/wash-out period) (12 weeks)
SCIG IgPro20 treatment (efficacy) (12 weeks)"|Up to 36 weeks|The FAS comprised all subjects treated with IgPro20 during the efficacy period who had the disease under study.||Infections per subject year|Participants||Number
826672|NCT01199705|Secondary|Rate of Infection Episodes (Serious and Non-serious) by Study Period, PPS Population|"The annualized rate of infection episodes (serious and non-serious) was based on the total number of infection episodes and the total number of subject study days for all subjects in the specified study periods (listed below) and analysis population and adjusted to 365 days.
Study periods:
IVIG treatment (up to 12 weeks)
SCIG IgPro20 treatment (wash-in/wash-out period) (12 weeks)
SCIG IgPro20 treatment (efficacy) (12 weeks)"|Up to 36 weeks|The PPS comprised all subjects with the disease under study who fulfilled the protocol-specified criteria for a) immunoglobulin treatment prior to and during the study, b) availability of evaluable serum IgG levels, and c) dose stability.||Infections per subject year|Participants||Number
826673|NCT01199705|Secondary|Number of Infection Episodes (Serious and Non-serious) by Study Period|"Number of infection episodes (serious and non-serious) presented by study period:
IVIG treatment: Study subjects were treated with their IVIG therapy with 3- or 4-weekly schedules for 3 dosing cycles (9 to 12 weeks; before being switched to SCIG treatment with IgPro20).
SCIG treatment (wash-in/wash-out; weeks 1 to 12): IgPro20 was administered subcutaneously with the first subcutaneous (SC) IgPro20 infusion starting 1 week after the last IVIG dose. Subjects were treated with weekly SC IgPro20 infusions for a 12-week wash-in/wash-out period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG therapy.
SCIG treatment (efficacy; weeks 13 to 24): After the SCIG wash-in/wash-out treatment, subjects were treated with weekly SC IgPro20 infusions for a 12-week efficacy period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG therapy."|Up to 36 weeks|||Number of infection episodes|||Number
826674|NCT01199705|Primary|IgG Trough Level|Geometric means of trough levels measured before 3 intravenous immunoglobulin (IVIG) infusions was compared with those of trough levels measured at steady-state for 3 subcutaneous immunoglobulin (SCIG) infusions (weeks 16, 20 and 24). The ratio of these geometric means was the primary outcome measure.|During IVIG period (IV 1, IV 2, IV 3) and during SCIG period at weeks 16, 20, and 24|The PPS comprised all subjects with the disease under study who fulfilled the protocol-specified criteria for a) immunoglobulin treatment prior to and during the study, b) availability of evaluable serum IgG levels, and c) dose stability. The FAS comprised all subjects treated with IgPro20 during the efficacy period who had the disease under study.||Ratio of Geometric Means||90% Confidence Interval|Number
826677|NCT01199744|Secondary|Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Who Were Also in the Indicated High-risk Categories|Participants with only hypertension were excluded from the cardiocirculatory disease category. Participants in high-risk categories are at risk for the aggravation of both infection and symptoms.|5 months (November 2009 to March 2010)|All participants who visited the sentinel 26 centers from the date of the contract to 31st March 2010 and were prescribed Relenza for the purpose of either treatment or prophylaxis of influenza||participants|||Number
826678|NCT01199744|Secondary|Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Categorized by Either Having Risk Factors for Influenza or Having no Risk Factors|Risk factors are defined as pregnancy; infancy; being elderly; and having chronic respiratory disease, cardiocirculatory disease, and/or diabetes.|5 months (November 2009 to March 2010)|All participants who visited the sentinel 26 centers from the date of the contract to 31st March 2010 and were prescribed Relenza for the purpose of either treatment or prophylaxis of influenza||participants|||Number
826679|NCT01199744|Secondary|Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Categorized by Either Having Complications or Having no Complications|A complication is defined as asthma.|5 months (November 2009 to March 2010)|All participants who visited the sentinel 26 centers from the date of the contract to 31st March 2010 and were prescribed Relenza for the purpose of either treatment or prophylaxis of influenza||participants|||Number
826680|NCT01199744|Secondary|Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Categorized by Reason for the Use of Relenza|The dose given for treatment of influenza is 10 mg twice daily for 5days. Prophylaxis is defined as a measure taken for the prevention of a disease or condition. The prophylactic dose of Relenza is 10 mg once daily for 10 days.|5 months (November 2009 to March 2010)|All participants who visited the sentinel 26 centers from the date of the contract to 31st March 2010 and were prescribed Relenza for the purpose of either treatment or prophylaxis of influenza||participants|||Number
826681|NCT01199744|Secondary|Number of Participants in the Indicated Age Categories With Either a Serious or Non-serious Adverse Drug Reaction||5 months (November 2009 to March 2010)|All participants who visited the sentinel 26 centers from the date of the contract to 31st March 2010 and were prescribed Relenza for the purpose of either treatment or prophylaxis of influenza||participants|||Number
826682|NCT01199744|Secondary|Number of Male and Female Participants With Either a Serious or Non-serious Adverse Drug Reaction||5 months (November 2009 to March 2010)|All participants who visited the sentinel 26 centers from the date of the contract to 31st March 2010 and were prescribed Relenza for the purpose of either treatment or prophylaxis of influenza||participants|||Number
826683|NCT01199744|Secondary|Number of Participants With Any Serious Adverse Drug Reaction (ADR)|"A serious ADR is defined as a serious adverse drug event (ADE) that a physician has determined to be related to the use of Relenza. Serious ADE: death caused by an ADR; an event that is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in severe symptoms requiring treatment so that symptoms do not lead to previously mentioned outcomes, and a congenital anomaly/birth defect. For a complete list of all serious ADRs recorded during the study, see Serious Adverse Events section."|5 months (November 2009 to March 2010)|All participants who visited the sentinel 26 centers from the date of the contract to 31st March 2010 and were prescribed Relenza for the purpose of either treatment or prophylaxis of influenza||participants|||Number
826684|NCT01199744|Primary|Number of Participants With Any Adverse Drug Reaction|"An adverse drug reaction is defined as a drug adverse event that a physician has determined to be related to the use of Relenza. A drug adverse event is defined as any unfavorable or unintended sign (including laboratory test abnormalities), symptom, or disease that occurs when a drug is administered, regardless of the relationship to the drug. For a complete list of all adverse drug reactions recorded during the study, see the section entitled Other (Non-serious) Adverse Events."|5 months (November 2009 to March 2010)|All participants who visited the sentinel 26 centers from the date of the contract to 31st March 2010 and were prescribed Relenza for the purpose of either treatment or prophylaxis of influenza||participants|||Number
826685|NCT01199822|Secondary|Number of Participants With Treatment Related AEs|Data presented are the number of participants who experienced a treatment related AE of any grade.|First dose to study completion up to 5.6 months|All enrolled participants who received at least 1 dose of study drug.||participants|||Number
826686|NCT01199822|Secondary|Number of Participants With Serum Anti-Olaratumab Antibody Assessment (Immunogenicity)|Participants with Treatment Emergent (TE) anti-olaratumab antibodies were participants with a 4-fold increase (2 dilutions) increase over a positive baseline antibody titer or for a negative baseline titer, a participant with an increase from the baseline to a level of 1:20.|First dose to study completion up to 5.6 months|All participants who received at least one dose of study drug and had evaluable baseline and evaluable post-baseline antibody data.||participants|||Number
826687|NCT01199822|Secondary|Volume of Distribution at Steady State (Vss)||Cycle 2: Pre-dose and up to 336 hours post-dose|Zero participants were analyzed because of insufficient amount of samples collected.|||||
826688|NCT01199822|Secondary|Clearance of Olaratumab at Steady State (CLss)|CLss is the volume of plasma (or blood) from which the drug is completely removed, or cleared, in a given time at steady-state.|Cycle 2: Pre-dose and up to 336 hours post-dose|All participants who received study drug and had PK data available to calculate CLss. Zero participants were analyzed for groups of 10 mg/kg IMC-3G3 and 15 mg/kg IMC-3G3 because of insufficient amount of samples collected. Due to limited data, CLss is not representative of the study population.||milliliters/hour/kilogram (mL/h/kg)||Geometric Coefficient of Variation|Geometric Mean
826689|NCT01199822|Secondary|Terminal Elimination Half-Life (t1/2) of Olaratumab|t1/2 is the time it takes for the drug concentration in serum to decrease to half the value observed at the beginning of the time period.|Cycle 2: Pre-dose and up to 336 hours post-dose|All participants who received study drug and had PK data available to calculate t1/2. Due to limited data and the relatively short duration of sample collection, t1/2 is not representative of the study population.||days||Full Range|Geometric Mean
826720|NCT01199965|Primary|Cmax of Dihydroergotamine After MAP0004 and IV DHE Administration in Smokers Versus Non-smokers|The maximum concentration (Cmax) is the highest concentration of a drug measured in the plasma. Plasma is the clear portion of the blood. The Cmax of Dihydroergotamine is reported in picograms per milliliter (pg/ml).|48 hours|Patients with available data at specified time points are included in the analysis population.||pg/ml||Standard Deviation|Geometric Mean
826690|NCT01199822|Secondary|Area Under the Concentration of Olaratumab Versus Time Curve During One Dosing Interval (AUCτ) Following Multiple Doses||Cycle 2: Pre-dose and up to 336 hours post-dose|All participants who received study drug and had PK data available to calculate AUCτ. Zero participants were analyzed for groups of 10 mg/kg IMC-3G3 and 15 mg/kg IMC-3G3 because of insufficient amount of samples collected. Due to the limited data, AUCτ is not representative of the study population.||micrograms*hours/milliliter (µg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
826691|NCT01199822|Primary|Maximum Concentration (Cmax) of Olaratumab Following Multiple Doses||Cycle 2: Pre-dose and up to 336 hours post-dose|All participants who received study drug and had pharmacokinetic (PK) data available to calculate Cmax. Due to the limited data, Cmax is not representative of the study population.||micrograms/milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
826692|NCT01199822|Primary|Number of Participants With a Dose- Limiting Toxicity (DLT) in Cycle 1|A DLT is defined as 1 of the following events, if considered by the investigator to be definitely, probably, or possibly related to olaratumab: NCI-CTCAE v4.02 Grade 4 neutropenia lasting >7 days; NCI-CTCAE v4.02 Grade ≥3 thrombocytopenia with signs of bleeding or requiring platelet transfusions; NCI-CTCAE v4.02 Grade ≥3 neutropenia associated with fever; NCI-CTCAE v4.02 Grade 3 or 4 nonhematologic toxicity, excluding electrolyte abnormality; NCI-CTCAE v4.02 Grade ≥3 skin toxicity despite best preemptive and supportive care; and/or NCI-CTCAE v4.02 Grade ≥3 diarrhea, nausea, or vomiting despite best preemptive and supportive care.|First dose through Cycle 1 (6 weeks/cycle)|All enrolled participants who received at least 1 dose of study drug.||participants|||Number
826693|NCT01199822|Primary|Number of Participants With SAEs|A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.|First dose to study completion up to 5.6 months|All enrolled participants who received at least 1 dose of study drug.||participants|||Number
826694|NCT01199822|Primary|Number of Participants With Adverse Events (AEs)|Data presented are the number of participants who experienced AEs of any grade and AEs of Grade ≥3 as determined by National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version (v) 4.02. A summary of serious adverse events (SAEs) and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.|First dose to study completion up to 5.6 months|All enrolled participants who received at least 1 dose of study drug.||participants|||Number
826695|NCT01199861|Secondary|Number of Participants With Adverse Events (AEs)|"Relationship to study drug was determined by the investigator (suspected/not suspected).
A serious AE is defined as an event which fulfills one of the following criteria:
is fatal or life-threatening;
results in persistent or significant disability/incapacity;
constitutes a congenital anomaly/birth defect;
requires inpatient hospitalization or prolongation of existing hospitalization;
is medically significant, i.e., jeopardizes the patient or may require intervention to prevent one of the outcomes listed above."|From first dose of study drug until 45 days after the last dose of study drug (130 days).|Safety set - all patients who received at least 1 dose of study drug.||participants|||Number
826696|NCT01199861|Secondary|Change From Baseline in Seasonal Influenza Vaccine Antibody-titer 6 Weeks After Vaccination|Change from Baseline was expressed by the ratio of post-vaccination to pre-vaccination antibody titer for each of the three strains included in the seasonal influenza vaccine. Inhibition of an immune response to each strain included in the seasonal influenza vaccine was assessed by the relative difference of the geometric mean antibody titer ratio on fingolimod as compared to placebo six weeks after a single dose of seasonal influenza vaccine.|Pre-vaccination (Week 6) and 6 weeks after vaccination (Study Week 12).|Full analysis set for whom data were available.||ratio|||Number
826697|NCT01199861|Secondary|Change From Baseline in Seasonal Influenza Vaccine Antibody-titer 3 Weeks After Vaccination|Change from Baseline was expressed by the ratio of post-vaccination to pre-vaccination antibody titer for each of the three strains included in the seasonal influenza vaccine. Inhibition of an immune response to each strain included in the seasonal influenza vaccine was assessed by the relative difference of the geometric mean antibody titer ratio on fingolimod as compared to placebo three weeks after a single dose of seasonal influenza vaccine.|Pre-vaccination (Week 6) and 3 weeks after vaccination (Study Week 9).|Full analysis set for whom data were available.||ratio|||Number
826698|NCT01199861|Secondary|Immune Response 6 Weeks After Tetanus Toxoid Booster|"Percentage of participants with an immune response to a single dose of tetanus toxoid six weeks after vaccination. A patient was considered a responder to tetanus toxoid booster vaccination if one of the following criteria was met:
Seroconversion: The pre-vaccination antibody titer measurement was <0.1 IU/ml and the post-vaccination measurement was ≥0.4 IU/ml.
Significant increase: The pre-vaccination antibody titer measurement was ≥0.1 IU/ml and the increase in antibody titer from this to the post-vaccination measurement was ≥4- fold."|Week 6 (pre-vaccination) and 6 weeks after vaccination (Study Week 12)|Full analysis set for whom data were available.||percentage of participants|||Number
826699|NCT01199861|Secondary|Immune Response 3 Weeks After Tetanus Toxoid Booster|"Percentage of participants with an immune response to a single dose of tetanus toxoid three weeks after vaccination. A patient was considered a responder to tetanus toxoid booster vaccination if one of the following criteria was met:
Seroconversion: The pre-vaccination antibody titer measurement was <0.1 IU/ml and the post-vaccination measurement was ≥0.4 IU/ml.
Significant increase: The pre-vaccination antibody titer measurement was ≥0.1 IU/ml and the increase in antibody titer from this to the post-vaccination measurement was ≥4- fold."|Week 6 (pre-vaccination) and 3 weeks after vaccination (Study Week 9)|Full analysis set for whom data were available.||percentage of participants|||Number
826700|NCT01199861|Secondary|Immune Response 6 Weeks After Seasonal Influenza Vaccination|"Percentage of participants who responded to treatment with the seasonal influenza vaccine 6 weeks after vaccination. Response was defined as patients fulfilling one of the following criteria for at least one of the three strains contained in the seasonal influenza vaccine:
Seroconversion: The pre-vaccination antibody titer measurement was <1:10 and the post-vaccination measurement is ≥1:40.
Significant increase in antibody titer: The pre-vaccination antibody titer measurement was ≥1:10 and the increase in antibody titer from this to the post-vaccination measurement is ≥ 4-fold."|Week 6 (pre-vaccination) and 6 weeks after vaccination (Study week 12).|Full analysis set for whom data were available.||percentage of participants|||Number
827503|NCT01207570|Primary|Ankle Passive Range of Motion|The ankle passive range of motion will be measured by a Myrin goniometer.|day 1 before treatment|All subjects received the intended treatment protocol and were included in the analysis. ITT was used to analyze the data.||degree||Standard Deviation|Mean
826701|NCT01199861|Primary|Immune Response 3 Weeks After Seasonal Influenza Vaccination|"Percentage of participants who responded to treatment with the seasonal influenza vaccine 3 weeks after vaccination. Response was defined as patients fulfilling one of the following criteria for at least one of the three strains contained in the seasonal influenza vaccine:
Seroconversion: The pre-vaccination antibody titer measurement was <1:10 and the post-vaccination measurement is ≥1:40.
Significant increase in antibody titer: The pre-vaccination antibody titer measurement was ≥1:10 and the increase in antibody titer from this to the post-vaccination measurement is ≥ 4-fold."|Week 6 (pre-vaccination) and 3 weeks after vaccination (Study week 9)|The full analysis set which includes all patients who were randomized and received at least 1 dose of study drug, and for whom data were available.||percentage of participants|||Number
826702|NCT01199926|Primary|Inflammation|The primary endpoint is the change in C reactive protein after the three month intervention|three months|||mg/L||Standard Deviation|Mean
826703|NCT01199926|Primary|Glucose Tolerance|The primary endpoint is the change in the area under the glucose curve following an oral glucose tolerance test prior to and after the three month intervention.|three months|Power statistical calculation was completed based on 80% power and error on lean mass measurement.||mmol/L/120 min||Standard Deviation|Mean
826704|NCT01199926|Primary|Muscle Function|The primary endpoint is the change in lean mass (kilograms) after the three month resistance exercise intervention.|three months|Power statistical calculation was completed based on 80% power and error on lean mass measurement.||kilograms||Standard Deviation|Mean
826705|NCT01199939|Secondary|Change From Baseline in Cluster of Differentiation 4 (CD4+) and Cluster of Differentiation 8 (CD8+) Cell Counts at Week 48||Baseline (Day 1) and Week 48|Intent-To-Treat participants enrolled in the study who took at least one dose of any of the study medications||cells/uL||Standard Deviation|Mean
826706|NCT01199939|Secondary|Number of Participants With Virologic Failure|Virologic Failure is defined as participant who is a rebounder or a non-responder. Rebounder participant is defined as a participant who is still in the study at Week 12 and first achieves 2 consecutive virologic responses (<50 copies/mL) followed by 2 consecutive non-responses or a discontinued participant (any reason) for which the last observed time point shows a non-response. Non responder participant is defined as a participant who is still in the study at Week 12 and never achieves 2 consecutive responses.|Baseline (Day 1) to Week 48|Intent-To-Treat participants enrolled in the study who took at least one dose of any of the study medications||Participants|||Number
826707|NCT01199939|Secondary|Time to Reach First Confirmed Virologic Response|CVR is defined as confirmed plasma Viral Load of less than 50 human immunodeficiency virus – type 1 (HIV-1) ribonucleic acid (RNA) copies/mL.|Baseline (Day 1) to Week 48|Intent-To-Treat participants enrolled in the study who took at least one dose of any of the study medications||Days||Standard Error|Mean
826708|NCT01199939|Secondary|Change From Baseline in Log10 Plasma Human Immunodeficiency Virus – Type 1 (HIV-1) Viral Load at Week 48||Baseline (Day 1) and Week 48|Intent-to-treat participants who received at least one dose of any of the study medication with evaluable data at Week 48||log10 Copies/mL||Full Range|Median
826709|NCT01199939|Secondary|Change From Baseline in Log10 Plasma Human Immunodeficiency Virus – Type 1 (HIV-1) Viral Load at Week 42||Baseline (Day 1) and Week 42|Intent-to-treat participants who received at least one dose of any of the study medication with evaluable data at Week 42||log10 Copies/mL||Full Range|Median
826710|NCT01199939|Secondary|Change From Baseline in Log10 Plasma Human Immunodeficiency Virus – Type 1 (HIV-1) Viral Load at Week 36||Baseline (Day 1) and Week 36|Intent-to-treat participants who received at least one dose of any of the study medication with evaluable data at Week 36||log10 Copies/mL||Full Range|Median
826711|NCT01199939|Secondary|Change From Baseline in Log10 Plasma Human Immunodeficiency Virus – Type 1 (HIV-1) Viral Load at Week 30||Baseline (Day 1) and Week 30|Intent-to-treat participants who received at least one dose of any of the study medication with evaluable data at Week 30||log10 Copies/mL||Full Range|Median
826712|NCT01199939|Secondary|Change From Baseline in Log10 Plasma Human Immunodeficiency Virus – Type 1 (HIV-1) Viral Load at Week 24||Baseline (Day 1) and Week 24|Intent-to-treat participants who received at least one dose of any of the study medication with evaluable data at Week 24||log10 Copies/mL||Full Range|Median
826713|NCT01199939|Secondary|Change From Baseline in Log10 Plasma Human Immunodeficiency Virus – Type 1 (HIV-1) Viral Load at Week 20||Baseline (Day 1) and Week 20|Intent-to-treat participants who received at least one dose of any of the study medication with evaluable data at Week 20||log10 Copies/mL||Full Range|Median
826714|NCT01199939|Secondary|Change From Baseline in Log10 Plasma Human Immunodeficiency Virus – Type 1 (HIV-1) Viral Load at Week 16||Baseline (Day 1) and Week 16|Intent-to-treat participants who received at least one dose of any of the study medication with evaluable data at Week 16||log10 Copies/mL||Full Range|Median
826715|NCT01199939|Secondary|Change From Baseline in Log10 Plasma Human Immunodeficiency Virus – Type 1 (HIV-1) Viral Load at Week 12||Baseline (Day 1) and Week 12|Intent-to-treat participants who received at least one dose of any of the study medication with evaluable data at Week 12||log10 Copies/mL||Full Range|Median
826716|NCT01199939|Secondary|Change From Baseline in Log10 Plasma Human Immunodeficiency Virus – Type 1 (HIV-1) Viral Load at Week 8||Baseline (Day 1) and Week 8|Intent-to-treat participants who received at least one dose of any of the study medication with evaluable data at Week 8||log10 Copies/mL||Full Range|Median
826717|NCT01199939|Secondary|Change From Baseline in Log10 Plasma Human Immunodeficiency Virus – Type 1 (HIV-1) Viral Load at Week 4||Baseline (Day 1) and Week 4|Intent-to-treat participants who received at least one dose of any of the study medication with evaluable data at Week 4||log10 Copies/mL||Full Range|Median
826718|NCT01199939|Primary|Number of Participants With Confirmed Virologic Response (CVR) at Week 48|CVR is defined as confirmed plasma Viral Load of less than 50 human immunodeficiency virus – type 1 (HIV-1) ribonucleic acid (RNA) copies/mL.|Week 48|Intent-To-Treat Non-Virologic failure (VF) censored: Participants who took at least one dose of any of the study medications and did not withdraw for reasons other than VF or experienced VF prior to discontinuation. Participants with evaluable data at Week 48||Participants|||Number
826719|NCT01199965|Primary|AUC(0-48) of Dihydroergotamine After MAP0004 and IV DHE Administration in Smokers and Non-smokers|The AUC(0-48) is the area under the plot of plasma concentration of drug against time after drug administration. Dihydroergotamine AUC(0-48) is reported in picograms times hour per milliliter (pg*h/ml).|48 hours|Patients with available data at specified time points are included in the analysis population.||pg*h/ml||Standard Deviation|Geometric Mean
826723|NCT01200069|Secondary|Subject Self Reported Numerical Rating of Incidence and Severity of Post Electroconvulsive Therapy Headache After Treatment Day 1|Subject self reported numerical rating of incidence and severity of Post ECT pain score for headache at 1, 6, 24 and 48 hours post procedure. Pain Rating 0= no pain, 2-4=moderate pain, 5-7=distressing severe pain, 8-9=intense very severe pain, 10=unbearable pain|1 hour, 6 hours, 24 hours & 48 hours following procedure|||units on a scale||Full Range|Mean
826724|NCT01200069|Primary|Myalgia Reported After Treatment #3|Subject self reported severity of myalgia based on a self reported assessment utilizing numeric rating scale 0=no myalgia, 1-3=mild myalgia (annoying, little interference with ADL);4-6=moderate (interferes significantly with ADL); 7-10 severe myalgia(unable to perform every day activities)|1 hour, 6 hour, 24 hour, 48 hour after 3rd ECT treatment|||units on a scale||Full Range|Median
826725|NCT01200069|Primary|Myalgia Reported on Treatment Day 2|Subject self reported numerical rating of incidence and severity of post ECT Myalgia after treatment day 2 0=no pain, 1-3=mild pain (annoying, little interference with ADL), 4-6= moderate,( interferes significantly with ADL) 7-10 severe pain (unable to perform everyday activities)|1 hour, 6 hours, 24 hours & 48 hours following procedure|||units on a scale||Full Range|Median
826726|NCT01200069|Primary|Subject Self Reported Numerical Rating of Incidence and Severity of Post-Electroconvulsive Therapy Myalgias After Treatment 1|subject self reporting rating scale for severity of myalgias utilizing numeric rating scale 0= no pain, 1-3= mild pain, annoyance with little interference with Activities of Daily Living (ADL), 4-6= moderate (interferes significantly with ADL, 7-10 = severe pain unable to perform ADL|Treatment day 1 at 1hour, 6 hour, 24 hours, 48 hours|subjects report at one hour following treatment||units on a scale||Full Range|Median
826727|NCT01200160|Secondary|Overall Safety and Tolerability of Niaspan|Evaluate overall safety of Niaspan through evaluation of adverse events|every 4 weeks for 24 weeks||||||
826728|NCT01200160|Secondary|Frequency of Flushing Events|evaluate occurrence of such events over time|every 4 weeks for 24 weeks||||||
826729|NCT01200160|Secondary|Evaluate Changes Induced by Niaspan at the Completion of the Study Against Base Line Values|Evaluation of changes in non-HDL-C (non-high-density lipoproteins-cholesterol) lipids, LDL- C (low-density lipoproteins-cholesterol), total cholesterol and triglycerides (including in subjects with high triglycerides ≥ 200 mg/dL), and the impact on the Framingham score|every 4 to 8 weeks for 24 weeks||||||
826730|NCT01200160|Primary|Effectiveness of Niaspan|"Increasing serum HDL-C (high-density lipoprotein - cholesterol) levels.
Calculated change in different variables (Difference percent for HDL, LDL, Non-HDL and Triglycerides) was obtained using the expression:
percent.change=((final.visit.variable-baseline.variable.))/(baseline.variable))*100 Then percent change is calculated at 24 weeks regarding baseline for different variables."|24 weeks regarding baseline visit (visit1)|||mg/dL||Standard Deviation|Mean
826731|NCT01200342|Primary|Number of Participants With Response|Tumor response by Response Evaluation Criteria in Solid Tumors for participants with measurable disease defined by presence of at least 1 measurable lesion at baseline: Complete Response (CR): disappearance all target lesions determined by 2 consecutive observations not less than 4 weeks apart. Partial Response (PR): >30% decrease in sum of LD of target lesions (LD) of target lesions taking as reference baseline sum LD determined by two consecutive observations not less than four weeks apart. Progression (PD): >20% increase in sum of LD of target lesions references smallest sum LD recorded since treatment started or appearance of one or more new lesions. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking references smallest sum LD since treatment started. Measurable: lesions accurately measured in at least 1 dimension (longest diameter to be recorded) as 20 mm with conventional techniques or as 10 mm with spiral CT s|Following two 3-week cycles|The efficacy-evaluable population defined as all subjects who completed at least two cycles of therapy and had at least one post-screening assessment of target and non-target lesions.||Participants|||Number
826732|NCT01200342|Primary|Overall Response Rate (Percentage Subjects With Confirmed Complete or Partial Response)|Tumor response by Response Evaluation Criteria in Solid Tumors for participants with measurable disease defined by presence of at least 1 measurable lesion at baseline: Complete Response (CR): disappearance all target lesions determined by 2 consecutive observations not less than 4 weeks apart. Partial Response (PR): >30% decrease in sum of LD of target lesions (LD) of target lesions taking as reference baseline sum LD determined by two consecutive observations not less than four weeks apart. Progression (PD): >20% increase in sum of LD of target lesions references smallest sum LD recorded since treatment started or appearance of one or more new lesions. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking references smallest sum LD since treatment started. Measurable: lesions accurately measured in at least 1 dimension (longest diameter to be recorded) as 20 mm with conventional techniques or as 10 mm with spiral CT s|Following two 3-week cycles|The efficacy-evaluable population defined as all subjects who completed at least two cycles of therapy and had at least one post-screening assessment of target and non-target lesions. Due to inadequate enrollment of study participants, no statistical analyses were able to be performed.||Percentage of Participants|||Number
826738|NCT01200368|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age)|Systemic events (any fever >= 37.5 degrees C, decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 7 days after the toddler dose|Safety population included all participants who received at least 1 dose of study vaccine. 'N'(number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic reaction. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction for each group, respectively.||percentage of participants|||Number
826739|NCT01200368|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age)|Systemic events (any fever >= 37.5 degrees C, decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 7 days after Dose 3 of infant series|Safety population included all participants who received at least 1 dose of study vaccine. 'N'(number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic reaction. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction for each group, respectively.||percentage of participants|||Number
826740|NCT01200368|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age)|Systemic events (any fever >= 37.5 degrees C, decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 7 days after Dose 2 of infant series|Safety population included all participants who received at least 1 dose of study vaccine. 'N'(number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic reaction. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction for each group, respectively.||percentage of participants|||Number
826741|NCT01200368|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age)|Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 7 days after Dose 1 of infant series|Safety population included all participants who received at least 1 dose of study vaccine. 'N'(number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic reaction. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction for each group, respectively.||percentage of participants|||Number
826742|NCT01200368|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 7 days after the toddler dose|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.||percentage of participants|||Number
826743|NCT01200368|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 7 days after Dose 3 of the infant series|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.||percentage of participants|||Number
826744|NCT01200368|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 7 days after Dose 2 of the infant series|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.||percentage of participants|||Number
826745|NCT01200368|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 7 days after Dose 1 of the infant series|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.||percentage of participants|||Number
826746|NCT01200368|Secondary|Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Toddler Dose|GMC was measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies.|1 month after the toddler dose|Evaluable toddler immunogenicity population. N (number of participants analyzed) = number of participants with determinate DTaP antibody level to serotype.||EU/mL||95% Confidence Interval|Geometric Mean
826747|NCT01200368|Secondary|Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Toddler Dose|GMC was measured in IU/mL and corresponding 2-sided 95% CI were evaluated for diphtheria and tetanus antibodies.|1 month after the toddler dose|Evaluable toddler immunogenicity population. N (number of participants analyzed) = number of participants with determinate DTaP antibody level to serotype.||IU/mL||95% Confidence Interval|Geometric Mean
826748|NCT01200368|Secondary|Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibodies 1 Month After the Infant Series|GMC was measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies.|1 month after the infant series|Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all expected doses, had blood drawn within the protocol-specified time frames, had at least 1 valid and determinate assay result for the proposed analysis, and had no major protocol violations.||EU/mL||95% Confidence Interval|Geometric Mean
826749|NCT01200368|Secondary|Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibodies 1 Month After the Infant Series|GMC was measured in IU/mL and corresponding 2-sided 95% CI were evaluated for diphtheria and tetanus antibodies.|1 month after the infant series|Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid and determinate assay result for the proposed analysis, and had no major protocol violations.||IU/mL||95% Confidence Interval|Geometric Mean
826750|NCT01200368|Secondary|Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Toddler Dose|Predefined antibody level was 0.1 IU/mL for diphtheria, 0.01 IU/mL for tetanus, 5 EU/mL for PT, and 5 EU/mL for FHA.|1 month after the toddler dose|Evaluable toddler immunogenicity population. N (number of participants analyzed) = number of participants with determinate DTaP antibody level to serotype.||percentage of participants||95% Confidence Interval|Number
826751|NCT01200368|Secondary|Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose|Antibody GMC as measured by mcg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw. To demonstrate non-inferiority, for 6 additional serotypes in 7vPnC + DTaP group, the lowest GMC observed among the 7 common serotypes in the group was taken as reference.|1 month after the toddler dose|Evaluable toddler immunogenicity set:eligible participants who received vaccine to which they were randomized at all 4 doses,had blood drawn within specified time,had >=1 valid assay result after toddler dose for analysis,had no major protocol violation.N(number of participants analyzed)=participants with determinate IgG antibody level to serotype.||mcg/mL||95% Confidence Interval|Geometric Mean
826752|NCT01200368|Secondary|Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After the Toddler Dose|Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants. To demonstrate non-inferiority, for 6 additional serotypes in 7vPnC + DTaP group, the lowest response observed among the 7 common serotypes in the group was taken as reference.|1 month after the toddler dose|Evaluable toddler immunogenicity set:eligible participants who received vaccine to which they were randomized at all 4 doses,had blood drawn within specified time,had >=1 valid assay result after toddler dose for analysis,had no major protocol violation.N(number of participants analyzed)=participants with determinate IgG antibody level to serotype.||percentage of participants||95% Confidence Interval|Number
826753|NCT01200368|Secondary|Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody for 6 Additional Serotypes 1 Month After the Infant Series|Antibody GMC for 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMs were calculated using all participants with available data for the specified blood draw. To demonstrate non-inferiority, for 6 additional serotypes in 7vPnC + DTaP group, the lowest GMC observed among the 7 common serotypes in the group was taken as reference.|1 month after the infant series|Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid and determinate assay result after Dose 3 for the proposed analysis, and had no major protocol violations.||mcg/mL||95% Confidence Interval|Geometric Mean
826754|NCT01200368|Primary|Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Infant Series|Predefined antibody levels were 0.1 International Units/mL (IU/mL) for diphtheria, 0.01 IU/mL for tetanus, 5 Enzyme-linked Immunosorbent Assay (ELISA) units/mL (EU/mL) for pertussis toxoid (PT), and 5 EU/mL for filamentous hemagglutinin (FHA).|1 month after the infant series|Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid and determinate assay result after Dose 3 for the proposed analysis, and had no major protocol violations.||percentage of participants||95% Confidence Interval|Number
826755|NCT01200368|Primary|Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody for 7 Common Serotypes 1 Month After the Infant Series|Antibody geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.|1 month after the infant series|Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid and determinate assay result after Dose 3 for the proposed analysis, and had no major protocol violations.||mcg/mL||95% Confidence Interval|Geometric Mean
835003|NCT01282203|Secondary|Cardiac Troponin (if Available)|Troponin T values measured within 24 hours of anesthesia were to be collected when available.|Within 24 hours after anesthesia|No data were available for the cardiac troponin outcome measure.|||||
826756|NCT01200368|Primary|Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series|Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants. To demonstrate non-inferiority, for 6 additional serotypes in 7vPnC + DTaP group, the lowest response observed among the 7 common serotypes in the group was taken as reference.|1 month after the infant series|Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid and determinate assay result after Dose 3 for the proposed analysis, and had no major protocol violations.||percentage of participants||95% Confidence Interval|Number
826757|NCT01193101|Secondary|Change From Week 8 to Week 9 in msDBP and msSBP After Single-blind Placebo Withdrawal at Week 8|From week 8 to week 9, participants entered a single-blind placebo withdrawal period to assess the effect of LCZ696 on blood pressure following its discontinuation. Participants, who were randomized to the LCZ696 treatment groups, were discontinued from CLCZ696 at the end of week 8 and all 4 treatment groups received single-blind placebo for 1 week post week 8. A positive change from week 8 to week 9 indicates worsening.|8 weeks, 9 weeks|Only participants from the full analysis, who had values at both week 8 and week 9, were included in the analysis. The FAS included all randomized participants.||mmHg||Standard Deviation|Mean
826758|NCT01193101|Secondary|Trough to Post-dosing Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP|Trough to post-dosing hour ratio at each post-dosing hour = [trough LSM of LCZ696 - trough LSM of placebo]/[post-dosing hour LSM of LCZ696 - post-dosing hour LSM of placebo]|baseline, 8 weeks|Full Analysis Set (FAS) The FAS included all randomized participants.||ratio|||Number
826759|NCT01193101|Secondary|Trough to Post-dosing Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP|Trough to post-dosing hour ratio at each post-dosing hour = [trough LSM of LCZ696 - trough LSM of placebo]/[post-dosing hour LSM of LCZ696 - post-dosing hour LSM of placebo]|baseline, 8 weeks|Full Analysis Set (FAS): The FAS included all randomized participants.||ratio|||Number
826760|NCT01193101|Secondary|Number of Participants Who Achieved Successful BP Control|BP control is defined as BP < 140/90 mmHg.|8 weeks|Participants from the full analysis set (FAS), who had week 8 values, were analyzed. The FAS included all randomized participants.||Participants|||Number
826761|NCT01193101|Secondary|Number of Participants Who Achieved a Successful Response in msSBP|Successful response in msSBP is defined as msSBP <140 mmHg or a reduction ≥ 20 mmHg from baseline.|8 weeks|Participants from the full analysis set (FAS), who had week 8 values, were analyzed. The FAS included all randomized participants.||Participants|||Number
826762|NCT01193101|Secondary|Number of Participants Who Achieved a Successful Response in msDBP|Successful response in msDBP is defined as msDBP <90 mmHg or a reduction ≥ 10 mmHg from baseline.|8 weeks|Participants from the full analysis set (FAS), who had week 8 values, were analyzed. The FAS included all randomized participants.||Participants|||Number
826763|NCT01193101|Secondary|Change From Baseline in Mean Ambulatory Pulse Pressure|Mean ambulatory pulse pressure is the difference in maSBP and maDBP (maSBP - maDBP). A negative change from baseline indicates improvement.|Baseline, 8 weeks|Participants from the full analysis set (FAS), who had both baseline and week 8 values, were analyzed. The FAS included all randomized participants.||mmHg||Standard Error|Least Squares Mean
826764|NCT01193101|Secondary|Change From Baseline in Mean Sitting Pulse Pressure|Mean sitting pulse pressure is the difference in msSBP and msDBP (msSBP - msDBP). A negative change from baseline indicates improvement.|Baseline, 8 weeks|Participants from the full analysis set (FAS), who had both baseline and week 8 values, were analyzed. The FAS included all randomized participants.||mmHg||Standard Error|Least Squares Mean
826765|NCT01193101|Secondary|Change From Baseline in Nighttime Mean Ambulatory DBP and SBP|Hourly mean ambulatory DBP and SBP post-dosing was calculated for each post-dosing hour over 24 hours by taking the average of the readings taken in the corresponding post-dosing hour at randomization and at week 8. Nighttime mean SBP and DBP were the averages of the hourly means between 10 pm and 6 am. A negative change from baseline indicates improvement.|Baseline, 8 weeks|Participants from the full analysis set (FAS), who had both baseline and week 8 values, were analyzed. The FAS included all randomized participants.||mmHg||Standard Error|Least Squares Mean
826766|NCT01193101|Secondary|Change From Baseline in Daytime Mean Ambulatory DBP and SBP|Hourly mean ambulatory DBP and SBP post-dosing was calculated for each post-dosing hour over 24 hours by taking the average of the readings taken in the corresponding post-dosing hour at randomization and at week 8. Daytime mean SBP and DBP were the averages of the hourly means between 6 am and 10 pm. A negative change from baseline indicates improvement.|Baseline, 8 weeks|Participants from the full analysis set (FAS), who had both baseline and week 8 values, were analyzed. The FAS included all randomized participants.||mmHg||Standard Error|Least Squares Mean
826767|NCT01193101|Secondary|Change From Baseline in 24 Hour Mean Ambulatory DBP and SBP|Hourly mean ambulatory DBP and SBP post-dosing was calculated for each post-dosing hour over 24 hours by taking the average of the readings taken in the corresponding post-dosing hour at randomization and at week 8. A negative change from baseline indicates improvement.|Baseline, 8 weeks|Participants from the full analysis set (FAS), who had both baseline and week 8 values, were analyzed. The FAS included all randomized participants.||mmHg||Standard Error|Least Squares Mean
826768|NCT01193101|Secondary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)|Sitting BP measurements were performed at screening through the end of the study at every study visit. A negative change from baseline indicates improvement.|Baseline, 8 weeks|Participants from the full analysis set (FAS), who had both baseline and week 8 values, were analyzed. The FAS included all randomized participants.||mmHg||Standard Error|Least Squares Mean
826769|NCT01193101|Primary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)|Sitting BP measurements were performed at screening through the end of the study at every study visit. A negative change from baseline indicates improvement.|Baseline, 8 weeks|Participants from the full analysis set (FAS), who had both baseline and week 8 values, were analyzed. The FAS included all randomized participants.||mmHg||Standard Error|Least Squares Mean
826771|NCT01193114|Secondary|BDI Depression Score|Beck Depression Inventory - II (BDI - II) Range from 0 (no depression) to 63 (severe depression)|6 months post-baseline measure|The analysis was conducted with all of the collected data. Discrepancies in number of participants between the Participant Flow Module and the analysis are due to missing data.||units on a scale||Standard Deviation|Mean
826772|NCT01193114|Secondary|BDI Depression Score|Beck Depression Inventory - II (BDI - II) Range from 0 (no depression) to 63 (severe depression)|3 months post-baseline measure|The analysis was conducted with all of the collected data. Discrepancies in number of participants between the Participant Flow Module and the analysis are due to missing data.||units on a scale||Standard Deviation|Mean
826773|NCT01193114|Primary|Percent Days of Substance Use in the Prior 3 Months.||9 months post-baseline measure|The analysis was conducted with all of the collected data. Discrepancies in number of participants between the Participant Flow Module and the analysis are due to missing data.||percent days of substance use||Standard Deviation|Mean
826774|NCT01193114|Primary|Percent Days of Substance Use in the Prior 3 Months.||6 months post-baseline measure|The analysis was conducted with all of the collected data. Discrepancies in number of participants between the Participant Flow Module and the analysis are due to missing data.||percent days of substance use||Standard Deviation|Mean
826775|NCT01193114|Primary|Percent Days of Substance Use in the Prior 3 Months.||3 months post-baseline measure|The analysis was conducted with all of the collected data. Discrepancies in number of participants between the Participant Flow Module and the analysis are due to missing data.||percent days of substance use||Standard Deviation|Mean
826776|NCT01193127|Secondary|Use of Pain Medications After Day 1|Ocular pain medications were identified by reviewing concomitant medications. Subject incidence of ocular pain medication use at day 1 and post day 1 were presented. Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|up to 30 days|All randomized subjects||participants|||Number
826777|NCT01193127|Secondary|Use of Pain Medications at Day 1|Ocular pain medications were identified by reviewing concomitant medications. Subject incidence of ocular pain medication use at day 1 and post day 1 were presented. Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|One day|All randomized subjects||participants|||Number
826778|NCT01193127|Secondary|Postoperative Use of Ophthalmic Anti-inflammatory Medications|Ophthalmic anti-inflammatory medications were identified by reviewing concomitant medications. Subject incidence of ophthalmic anti-inflammatory medication use by post-surgery day was presented. Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|up to 30 days|All randomized subjects||participants|||Number
826779|NCT01193127|Secondary|Ocular Pain VAS Score After Day 0|VAS pain scores (where 0 = no pain and 100 = worst possible pain) after the day of surgery were summarized.|43 days|Subjects with data at time point.||mm||Standard Deviation|Mean
826780|NCT01193127|Secondary|Postoperative Mean Anterior Chamber Cell Count, Day 30|The mean anterior chamber cell count was calculated as the average of the two anterior chamber cell counts. If a cell count was indicated as > 30, it was imputed as 45 for the purpose of treatment comparisons which was performed using pairwise Wilcoxon tests.|30 days|Subjects with data at time point.||cells||Standard Deviation|Mean
826781|NCT01193127|Secondary|Postoperative Mean Anterior Chamber Cell Count, Day 14|The mean anterior chamber cell count was calculated as the average of the two anterior chamber cell counts. If a cell count was indicated as > 30, it was imputed as 45 for the purpose of treatment comparisons which was performed using pairwise Wilcoxon tests.|14 days|Subjects with data at time point.||cells||Standard Deviation|Mean
826782|NCT01193127|Secondary|Postoperative Mean Anterior Chamber Cell Count, Day 7|The mean anterior chamber cell count was calculated as the average of the two anterior chamber cell counts. If a cell count was indicated as > 30, it was imputed as 45 for the purpose of treatment comparisons which was performed using pairwise Wilcoxon tests.|Seven days|Subjects with data at time point.||cells||Standard Deviation|Mean
826783|NCT01193127|Secondary|Postoperative Mean Anterior Chamber Cell Count, Day 2|The mean anterior chamber cell count was calculated as the average of the two anterior chamber cell counts. If a cell count was indicated as > 30, it was imputed as 45 for the purpose of treatment comparisons which was performed using pairwise Wilcoxon tests.|Two days|Subjects with data at time point.||cells||Standard Deviation|Mean
826784|NCT01193127|Secondary|Postoperative Mean Anterior Chamber Cell Count, Day 1|The mean anterior chamber cell count was calculated as the average of the two anterior chamber cell counts. If a cell count was indicated as > 30, it was imputed as 45 for the purpose of treatment comparisons which was performed using pairwise Wilcoxon tests.|One day|Subjects with data at time point.||cells||Standard Deviation|Mean
826785|NCT01193127|Secondary|Postoperative Mean Anterior Chamber Cell Count, Two Hours Post-Surgery|The mean anterior chamber cell count was calculated as the average of the two anterior chamber cell counts. If a cell count was indicated as > 30, it was imputed as 45 for the purpose of treatment comparisons which was performed using pairwise Wilcoxon tests.|Two hours|Subjects with data at time point.||cells||Standard Deviation|Mean
826786|NCT01193127|Secondary|Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 30|"Number of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject’s anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.
Grading was as follows:
Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.
Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous"|30 days|Subjects with scores at time point.||participants|||Number
826929|NCT01193348|Secondary|Pharmacokinetics (PK) and Pharmacodynamics (PD); Minimum and Maximum Blood Concentration (Body Weight Cohort ≥40kg) N=5||Induction Phase was between 1 and 4 weeks in length depending on patient weight cohort. Maintenance Phase was started either 2 weeks or 3 weeks after induction phase depending on patient weight cohort|PK parameters Cmin and Cmax were estimated using a population PK model developed from the observed PK concentration data.||micrograms/mL||Standard Deviation|Mean
826787|NCT01193127|Secondary|Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 14|"Number of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject’s anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.
Grading was as follows:
Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.
Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous"|14 days|Subjects with scores at time point.||participants|||Number
826788|NCT01193127|Secondary|Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 7|"Number of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject’s anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.
Grading was as follows:
Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.
Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous"|Seven days|Subjects with scores at time point.||participants|||Number
826789|NCT01193127|Secondary|Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 2|"Number of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject’s anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.
Grading was as follows:
Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.
Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous"|Two days|Subjects with scores at time point.||participants|||Number
826790|NCT01193127|Secondary|Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 1|"Number of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject’s anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.
Grading was as follows:
Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.
Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous"|One day|Subjects with scores at time point.||participants|||Number
826791|NCT01193127|Secondary|Subjects With Postoperative Ocular Inflammation SOIS = 0, Two Hours Post-surgery|"Number of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject’s anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.
Grading was as follows:
Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.
Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous"|Two hours|Subjects with scores at time point.||participants|||Number
826792|NCT01193127|Secondary|Subjects With Postoperative Ocular Inflammation SOIS = 0, Baseline|"Number of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject’s anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.
Grading was as follows:
Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.
Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous"|Baseline|Subjects with scores at time point.||participants|||Number
826811|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Haziness Six Hours Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Six hours|Subjects with scores at time point.||participants|||Number
826812|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Haziness Two Hours Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Two hours|Subjects with scores at time point.||participants|||Number
826793|NCT01193127|Secondary|Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 30|"Postoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject’s anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.
Grading was as follows:
Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.
Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous"|30 days|Subjects with scores at time point.||units on a scale||Standard Deviation|Mean
826794|NCT01193127|Secondary|Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 14|"Postoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject’s anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.
Grading was as follows:
Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.
Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous"|14 days|Subjects with scores at time point.||units on a scale||Standard Deviation|Mean
826795|NCT01193127|Secondary|Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 7|"Postoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject’s anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.
Grading was as follows:
Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.
Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous"|Seven days|Subjects with scores at time point.||units on a scale||Standard Deviation|Mean
826796|NCT01193127|Secondary|Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 2|"Postoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject’s anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.
Grading was as follows:
Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.
Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous"|Two days|Subjects with scores at time point.||units on a scale||Standard Deviation|Mean
826797|NCT01193127|Secondary|Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 1|"Postoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject’s anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.
Grading was as follows:
Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.
Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous"|One day|Subjects with scores at time point.||units on a scale||Standard Deviation|Mean
826798|NCT01193127|Secondary|Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, 2 Hours Post Surgery|"TPostoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject’s anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.
Grading was as follows:
Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.
Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous"|Two hours|Subjects with scores at time point.||units on a scale||Standard Deviation|Mean
826813|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Foreign Body Sensation 30 Days Post-Surgery/Early Termination|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Up to 30 days|Subjects with scores at time point.||participants|||Number
826799|NCT01193127|Secondary|Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Baseline|"Postoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject’s anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.
Grading was as follows:
Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.
Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous"|Baseline|Subjects with scores at time point.||units on a scale||Standard Deviation|Mean
826800|NCT01193127|Secondary|Best Corrected Visual Acuity (BVCA) - Log Score, Day 30|Best-Corrected Visual Acuity (BCVA) was summarized by the ETDRS visual acuity log score. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis. Treatment comparisons for BCVA were performed by pairwise Wilcoxon tests.|30 days|Subjects with scores at time point.||Log score||Standard Deviation|Mean
826801|NCT01193127|Secondary|Best Corrected Visual Acuity (BVCA) - Log Score, Day 14|Best-Corrected Visual Acuity (BCVA) was summarized by the ETDRS visual acuity log score. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis. Treatment comparisons for BCVA were performed by pairwise Wilcoxon tests.|14 days|Subjects with scores at time point.||Log score||Standard Deviation|Mean
826802|NCT01193127|Secondary|Best Corrected Visual Acuity (BVCA) - Log Score, Day 7|Best-Corrected Visual Acuity (BCVA) was summarized by the ETDRS visual acuity log score. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis. Treatment comparisons for BCVA were performed by pairwise Wilcoxon tests.|Seven days|Subjects with scores at time point.||Log score||Standard Deviation|Mean
826803|NCT01193127|Secondary|Best Corrected Visual Acuity (BVCA) - Log Score, Day 2|Best-Corrected Visual Acuity (BCVA) was summarized by the ETDRS visual acuity log score. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis. Treatment comparisons for BCVA were performed by pairwise Wilcoxon tests.|Two days|Subjects with scores at time point.||Log score||Standard Deviation|Mean
826804|NCT01193127|Secondary|Best Corrected Visual Acuity (BVCA) - Log Score, Day 1|Best-Corrected Visual Acuity (BCVA) was summarized by the ETDRS visual acuity log score. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis. Treatment comparisons for BCVA were performed by pairwise Wilcoxon tests.|One day|Subjects with scores at time point.||Log score||Standard Deviation|Mean
826805|NCT01193127|Secondary|Best Corrected Visual Acuity (BVCA) - Log Score, Baseline|Best-Corrected Visual Acuity (BCVA) was summarized by the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity log score. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis. Treatment comparisons for BCVA were performed by pairwise Wilcoxon tests.|Baseline|Subjects with scores at time point.||Log score||Standard Deviation|Mean
826806|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Haziness 30 Days Post-Surgery/Early Termination|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Up to 30 days|Subjects with scores at time point.||participants|||Number
826807|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Haziness 14 Days Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|14 days|Subjects with scores at time point.||participants|||Number
826808|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Haziness Seven Days Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Seven days|Subjects with scores at time point.||participants|||Number
826809|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Haziness Two Days Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Two days|Subjects with scores at time point.||participants|||Number
826810|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Haziness One Day Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|One day|Subjects with scores at time point.||participants|||Number
826814|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Foreign Body Sensation 14 Days Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|14 days|Subjects with scores at time point.||participants|||Number
826815|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Foreign Body Sensation Seven Days Post-Surgery 7 Days|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Seven days|Subjects with scores at time point.||participants|||Number
826816|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Foreign Body Sensation Two Days Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Two days|Subjects with scores at time point.||participants|||Number
826817|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Foreign Body Sensation One Day Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|One day|Subjects with scores at time point.||participants|||Number
826818|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Foreign Body Sensation Six Hours Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Six hours|Subjects with scores at time point.||participants|||Number
826819|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Foreign Body Sensation Two Hours Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Two hours|Subjects with scores at time point.||participants|||Number
826820|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Itching 30 Days Post-Surgery/Early Termination|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Up to 30 days|Subjects with scores at time point.||participants|||Number
826821|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Itching 14 Days Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|14 days|Subjects with scores at time point.||participants|||Number
826822|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Itching Seven Days Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Seven days|Subjects with scores at time point.||participants|||Number
826823|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Itching Two Days Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Two days|Subjects with scores at time point.||participants|||Number
826824|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Itching One Day Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|One day|Subjects with scores at time point.||participants|||Number
826825|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Itching 6 Hours Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Six hours|Subjects with scores at time point.||participants|||Number
826826|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Itching Two Hours Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Two hours|Subjects with scores at time point.||participants|||Number
826864|NCT01193218|Secondary|Change From Baseline in FPG|Change from baseline in FPG after 12 weeks of treatment|baseline and 12 weeks|Full analysis set (FAS)||mg/dL||Standard Error|Least Squares Mean
826827|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Eye Discharge 30 Days Post-Surgery/Early Termination|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Up to 30 days|Subjects with scores at time point.||participants|||Number
826828|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Eye Discharge 14 Days Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|14 days|Subjects with scores at time point.||participants|||Number
826829|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Eye Discharge Seven Days Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Seven days|Subjects with scores at time point.||participants|||Number
826830|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Eye Discharge Two Days Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Two days|Subjects with scores at time point.||participants|||Number
826831|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Eye Discharge One Day Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|One day|Subjects with scores at time point.||participants|||Number
826832|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Eye Discharge Six Hours Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Six hours|Subjects with scores at time point.||participants|||Number
826833|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Eye Discharge 2 Hours Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Two hours|Subjects with scores at time point.||participants|||Number
826834|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Photophobia 30 Days Post-Surgery /Early Termination|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Up to 30 days|Subjects with scores at time point.||participants|||Number
826835|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Photophobia 14 Days Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|14 days|Subjects with scores at time point.||participants|||Number
826836|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Photophobia Seven Days Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Seven days|Subjects with scores at time point.||participants|||Number
826837|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Photophobia Two Days Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Two days|Subjects with scores at time point.||participants|||Number
826838|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Photophobia One Day Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|One day|Subjects with scores at time point.||participants|||Number
826839|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Photophobia Six Hours Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Six hours|Subjects with scores at time point.||participants|||Number
835431|NCT01287416|Secondary|Suicidal Ideation in Past 2 Days at Baseline|Number of people who endorsed having thought about suicide in the past 2 days as measured at baseline (not at all vs a little to a lot)|July 19-20, 2010|||participants|||Number
826840|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Photophobia Two Hours Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Two hours|Subjects with scores at time point.||participants|||Number
826841|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Tearing, 30 Days Post-Surgery/ Early Termination|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|up to 30 days|Subjects with scores at time point.||participants|||Number
826842|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Tearing, 14 Days Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|14 days|Subjects with scores at time point.||participants|||Number
826843|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Tearing, Seven Days Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Seven days|Subjects with scores at time point.||participants|||Number
826844|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Tearing, Two Days Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Two days|Subjects with scores at time point.||participants|||Number
826845|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Tearing, One Day Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel-Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|One day|Subjects with scores at time point.||participants|||Number
826846|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Tearing, Six Hours Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel-Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Six hours|Subjects with scores at time point.||participants|||Number
826847|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Tearing, Two Hours Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Two hours|Subjects with scores at time point.||participants|||Number
826848|NCT01193127|Primary|Ocular Pain Visual Analog Scale (VAS) Score (mm) Within 12 Hours Postoperatively|For the primary analysis of this endpoint, only the results on the day of operation at 2, 4, 6, 8 and 10-12 hours were utilized. The VAS scores (where 0 = no pain and 100 = worst possible pain) were summarized by treatment group and time point. Repeated measures analyses of variance were used to test for differences in postoperative ocular pain. The repeated measures model included VAS pain score as the response variable and treatment (OMS302, phenylephrine hydrochloride (PE), and vehicle), time point (as a categorical variable) and the stratification factor LOCS II grade as predictor variables. A generalized estimating equation (GEE) approach with an AR(1) working correlation structure was used.|through 12 hours post-surgery|Subjects with postoperative VAS scores.||units on a scale||Standard Deviation|Mean
826849|NCT01193127|Primary|Pupil Diameter (mm) During Surgery|Pupil diameter from surgical baseline (immediately prior to surgical incision) to the end of the surgical procedure (wound closure) was summarized using descriptive statistics by treatment group and time point. Repeated measures analyses of variance were used to test for differences in the maintenance of mydriasis. The repeated measures model included change from baseline pupil diameter as the response variable and treatment (OMS302, ketorolac tromethamine, and vehicle), time point (as a categorical variable) and the stratification factor lens opacities classification system II (LOCS II) grade as predictor variables. A generalized estimating equation (GEE) approach with an AR(1) working-correlation structure was used.|During surgery (immediately prior to surgical incision to wound closure)|Subjects with interpretable video recordings obtained during surgery.||mm||Standard Deviation|Mean
826850|NCT01193153|Secondary|Double-blind: Change From Baseline in Clinical Global Impression - Severity Schizoaffective Scale (CGI-S-SCA) Overall Score at Endpoint|"The CGI-S-SCA is a syndrome-specific 7-point scale (from 1 indicating not ill to 7 indicating very severely ill) that includes an overall severity score as well as scores for the positive, negative, manic, and depressive domains of the illness. The CGI-S-SCA was used to assess the level of overall impairment, as well as that related to each domain, at the time of the visit and for the week prior to the visit."|Baseline and Endpoint (Week 64/LOCF) in double-blind period|DB ITT analysis set which included all randomly assigned participants who received at least one injection of double-blind study medication. LOCF method was used to impute missing values. 'n' signifies participants who were evaluable at each specified time point for each arm, respectively.||Units on a scale||Standard Deviation|Mean
826865|NCT01193218|Secondary|Occurrence of Treat to Target Efficacy Response|Occurrence of treat to target efficacy response, that is an HbA1c of <7.0% after 12 weeks of treatment|baseline and 12 weeks|Full analysis set (FAS)||percentage of participants||95% Confidence Interval|Number
826851|NCT01193153|Secondary|Open-label: Change From Baseline in Clinical Global Impression - Severity Schizoaffective Scale (CGI-S-SCA) Overall Score at Endpoint|"The CGI-S-SCA is a syndrome-specific 7-point scale (from 1 indicating not ill to 7 indicating very severely ill) that includes an overall severity score as well as scores for the positive, negative, manic, and depressive domains of the illness. The CGI-S-SCA was used to assess the level of overall impairment, as well as that related to each domain, at the time of the visit and for the week prior to the visit."|Baseline and Endpoint (Week 13/LOCF) in OL Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period|OL ITT analysis set which included all randomly assigned participants who received at least one injection of open-label study medication. LOCF method was used to impute missing values. 'n' signifies participants who were evaluable at each specified time point.||Units on a scale||Standard Deviation|Mean
826852|NCT01193153|Secondary|Double-blind: Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Endpoint|The YMRS was designed to measure the severity of manic symptoms, to gauge the effect of treatment on mania severity, and to detect a return of manic symptoms (for example relapse or recurrence). YMRS is a checklist of 11 items that are ranked on a scale of 0 to 4 or 0 to 8. Seven of the items (elevated mood, increased motor activity, sexual interest, sleep, language-thought disorder, appearance, and insight) are ranked 0 to 4 and have descriptors associated with each severity level (that is, 0, 1, 2, 3, 4). Four of the items (irritability, speech, content, and disruptive-aggressive behavior) are scored 0 to 8 and have descriptors for every other increment (that is, 0, 2, 4, 6, 8). The item score is based on participant's report of his or her condition and clinician's behavioral observations during the interview, with emphasis on the latter. Higher scores indicate worsening. Responses are summed to yield YMRS total score ranging from 0 to 60.|Baseline and Endpoint (Week 64/LOCF) in double-blind period|DB ITT analysis set which included all randomly assigned participants who received at least one injection of double-blind study medication. LOCF method was used to impute missing values. 'n' signifies participants who were evaluable at each specified time point for each arm, respectively.||Units on a scale||Standard Deviation|Mean
826853|NCT01193153|Secondary|Open-label: Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Endpoint|The YMRS was designed to measure the severity of manic symptoms, to gauge the effect of treatment on mania severity, and to detect a return of manic symptoms (for example relapse or recurrence). YMRS is a checklist of 11 items that are ranked on a scale of 0 to 4 or 0 to 8. Seven of the items (elevated mood, increased motor activity, sexual interest, sleep, language-thought disorder, appearance, and insight) are ranked 0 to 4 and have descriptors associated with each severity level (that is, 0, 1, 2, 3, 4). Four of the items (irritability, speech, content, and disruptive-aggressive behavior) are scored 0 to 8 and have descriptors for every other increment (that is, 0, 2, 4, 6, 8). The item score is based on participant's report of his or her condition and clinician's behavioral observations during the interview, with emphasis on the latter. Higher scores indicate worsening. Responses are summed to yield YMRS total score ranging from 0 to 60.|Baseline and Endpoint (Week 13/LOCF) in OL Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period|OL ITT analysis set which included all randomly assigned participants who received at least one injection of open-label study medication. LOCF method was used to impute missing values. 'n' signifies participants who were evaluable at each specified time point.||Units on a scale||Standard Deviation|Mean
826854|NCT01193153|Secondary|Double-blind: Change From Baseline in Hamilton Rating Scale for Depression (HAM-D-21) Total Score at Endpoint|The HAM-D-21 is a 21-item, clinician-rated scale to evaluate depressed mood as well as the vegetative and cognitive symptoms of depression. The items are rated on a 5-point (0 to 4) scale. The 5-point scale items use a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). A rating of 4 is usually reserved for extreme symptoms. The responses for all 21 items are summed to yield the HAM-D-21 total score that ranges from 0-63.|Baseline and Endpoint (Week 64/LOCF) in double-blind period|DB ITT analysis set which included all randomly assigned participants who received at least one injection of double-blind study medication. LOCF method was used to impute missing values. 'n' signifies participants who were evaluable at each specified time point for each arm, respectively.||Units on a scale||Standard Deviation|Mean
826855|NCT01193153|Secondary|Open-label: Change From Baseline in Hamilton Rating Scale for Depression (HAM-D-21) Total Score at Endpoint|The HAM-D-21 is a 21-item, clinician-rated scale to evaluate depressed mood as well as the vegetative and cognitive symptoms of depression. The items are rated on a 5-point (0 to 4) scale. The 5-point scale items use a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). A rating of 4 is usually reserved for extreme symptoms. The responses for all 21 items are summed to yield the HAM-D-21 total score that ranges from 0-63.|Baseline and Endpoint (Week 13/LOCF) in OL Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period|OL ITT analysis set which included all randomly assigned participants who received at least one injection of open-label study medication. LOCF method was used to impute missing values. n' signifies participants who were evaluable at each specified time point.||Units on a scale||Standard Deviation|Mean
826856|NCT01193153|Secondary|Double-blind: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Endpoint|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Baseline and Endpoint (Week 64/LOCF) in double-blind period|DB ITT analysis set which included all randomly assigned participants who received at least one injection of double-blind study medication. LOCF method was used to impute missing values. 'n' signifies participants who were evaluable at each specified time point for each arm, respectively.||Units on a scale||Standard Deviation|Mean
826866|NCT01193218|Primary|Change From Baseline in HbA1c After 12 Weeks of Treatment.|The primary endpoint in this study is the change from baseline in HbA1c after 12 weeks of treatment.|baseline and 12 weeks|Full analysis set (FAS)||percentage of HbA1c||Standard Error|Least Squares Mean
826930|NCT01193348|Secondary|Pharmacokinetics (PK) and Pharmacodynamics (PD); Minimum and Maximum Blood Concentration (Body Weight Cohort 30 - <40kg) N=1||Induction Phase was between 1 and 4 weeks in length depending on patient weight cohort. Maintenance Phase was started either 2 weeks or 3 weeks after induction phase depending on patient weight cohort|PK parameters Cmin and Cmax were estimated using a population PK model developed from the observed PK concentration data. N=0 in the maintenance phase because the patient changed to ≥40kg body weight category||micrograms/mL||Standard Deviation|Mean
826857|NCT01193153|Secondary|Open-label: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Endpoint|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Baseline and Endpoint (Week 13/LOCF) in OL Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period|OL ITT analysis set which included all randomly assigned participants who received at least one injection of open-label study medication. LOCF method was used to impute missing values. 'n' signifies participants who were evaluable at each specified time point.||Units on a scale||Standard Deviation|Mean
826858|NCT01193153|Secondary|Double-blind: Number of Participants With Personal and Social Performance (PSP) Categorical Scores|The PSP scale was designed to assess the degree of dysfunction a participant exhibits during a month prior to any visit within 4 domains of behavior: a) socially useful activities, b) personal and social relationships, c) self-care, and d) disturbing and aggressive behavior, each rated on 6-point scale (1=absent to 6=very severe). Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning. Number of participants in each specific category; good functioning (PSP total score >70), variable functioning (PSP total score between 31 and 70), and poor functioning (PSP total score <=30) were assessed.|Baseline and Endpoint (Week 64/LOCF) in DB period|DB ITT analysis set which included all randomly assigned participants who received at least one injection of double-blind study medication. LOCF method was used to impute missing values.'n' signifies participants who were evaluable at each specified time point for each arm, respectively.||participants|||Number
826859|NCT01193153|Secondary|Double-blind: Change From Baseline in Personal and Social Performance (PSP) Total Score at Endpoint|The PSP scale was designed to assess the degree of dysfunction a participant exhibits during a month prior to any visit within 4 domains of behavior: a) socially useful activities, b) personal and social relationships, c) self-care, and d) disturbing and aggressive behavior, each rated on 6-point scale (1=absent to 6=very severe). Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning. A score lying between 71 and 100 indicated a good functioning; one between 31 and 70 indicated varying degrees of difficulty, and a score of <=30 indicated functioning so poor that participant required intensive supervision.|Baseline and Endpoint (Week 64/LOCF) in double-blind period|DB ITT analysis set which included all randomly assigned participants who received at least one injection of double-blind study medication. LOCF method was used to impute missing values. 'n' signifies participants who were evaluable at each specified time point for each arm, respectively.||Units on a Scale||Standard Error|Least Squares Mean
826860|NCT01193153|Secondary|Open-label: Change From Baseline in Personal and Social Performance (PSP) Total Score at Endpoint|The PSP scale was designed to assess the degree of dysfunction a participant exhibits during a month prior to any visit within 4 domains of behavior: a) socially useful activities, b) personal and social relationships, c) self-care, and d) disturbing and aggressive behavior, each rated on 6-point scale (1=absent to 6=very severe). Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning. A score lying between 71 and 100 indicated a good functioning; one between 31 and 70 indicated varying degrees of difficulty, and a score of <=30 indicated functioning so poor that participant required intensive supervision.|Baseline and Endpoint (Week 13/LOCF) in Open-label (OL) Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period|OL ITT analysis set which included all randomly assigned participants who received at least one injection of open-label study medication. Last Observation Carried Forward (LOCF) method was used to impute missing values. 'n' signifies participants who were evaluable at each specified time point.||Units on a Scale||Standard Deviation|Mean
826861|NCT01193153|Secondary|Double-blind: Change From Baseline in Personal and Social Performance (PSP) Total Score at Week 64 (Total Mixed Model Repeated Measures [MMRM] Analysis of Covariance [ANCOVA])|The PSP scale was designed to assess the degree of dysfunction a participant exhibits during a month prior to any visit within 4 domains of behavior: a) socially useful activities, b) personal and social relationships, c) self-care, and d) disturbing and aggressive behavior, each rated on 6-point scale (1=absent to 6=very severe). Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning. A score lying between 71 and 100 indicated a good functioning; one between 31 and 70 indicated varying degrees of difficulty, and a score of <=30 indicated functioning so poor that participant required intensive supervision.|Baseline and Week 64 of double blind relapse prevention period|DB ITT analysis set which included all randomly assigned participants who received at least one injection of double-blind study medication. 'n' signifies participants who were evaluable at each specified time point for each arm, respectively.||Units on a scale||Standard Error|Least Squares Mean
826862|NCT01193153|Primary|Double-blind: Percentage of Participants Who Experienced Relapse|Relapse was defined as first occurrence of any 1 of following:psychiatric hospitalization due to worsening symptoms; any intervention employed to avert imminent hospitalization due to worsening symptoms or need for additional antipsychotic,antidepressants/mood stabilizing medication; deliberate self-injury,suicidal/homicidal ideation that is clinically significant as determined by investigator,or violent behavior resulting in clinically significant injury to another person or property damage; worsening of any 1 or more of 8 selected positive and negative syndrome scale(PANSS) items to a score of greater than or equal to (>= 6) after randomization(if the score for the corresponding item was less than or equal to [<=] 4 at randomization); worsening of certain other measures in specific ways at 2 consecutive visits. Relapse by subgroup of participants on monotherapy,adjunctive therapy to antidepressants/mood stabilizers,participants with psychotic symptoms/mood symptoms was examined.|Day 1 up to Month 15 of double blind relapse prevention period|Double-blind(DB) Intent-to-Treat(ITT) analysis set included all randomly assigned participants who received at least 1 injection of DB study medication.‘n’ signifies participants who were evaluable for each specified category,for each arm.||percentage of participants|||Number
826863|NCT01193218|Other Pre-specified|Confirmed Hypoglycaemic Adverse Events|Number of patients with confirmed hypoglycaemic adverse events|between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days|Treated patients||participants|||Number
826867|NCT01193244|Secondary|Time to Deterioration in Global Health Status|Global health status deterioration is defined as a drop greater than 16 points from the baseline assessment, confirmed at least 3 weeks later, on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core Module 30 (EORTC QLQ-C30) index after the score has been linearly transformed to a 0 to 100 scale. EORTC QLQ-C30 consists of 30 questions, where question 1 to 28 can be answered with 1: Not at all, 2: A little, 3: Quite a bit, 4: Very much and question 29 to 30 with 1: Very poor to 7: Excellent. For subscales a high score from 0-100 indicates: high global quality of life, high level of functioning (physical, role, emotional, cognitive, social) or a high level of symptoms (fatigue, nausea, pain, dyspnea, insomnia, appetite loss, constipation, diarrhoea, financial difficulties).|Baseline until EOT (approximately up to 4.7 years)|The ITT population included all participants who were randomized.||months||95% Confidence Interval|Median
826868|NCT01193244|Secondary|Percentage of Participants With Objective Response|Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1. A CR was defined as the disappearance of all target lesions determined by computerized tomography (CT) or MRI. Any pathological lymph nodes (whether target or non-target) must have had reduction in short axis to <10 millimetre (mm). A PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of longest diameters of non-lymph node lesions and of the short diameter or short axis of lymph nodes.|Baseline until disease progression or death, whichever occurred first (approximately up to 4.7 years)|The Response Evaluation Criteria in Solid Tumors (RECIST) evaluable population included all participants who had measurable disease by RECIST 1.1 at the baseline assessment.||percentage of participants||95% Confidence Interval|Number
826869|NCT01193244|Secondary|Time to Subsequent Antineoplastic Therapy|Time to subsequent antineoplastic therapy is defined as the time from randomization to the start of any alternate antineoplastic therapy for prostate cancer. Deaths due to disease progression prior to antineoplastic therapy for prostate cancer are considered as events. Otherwise, time to next therapy is censored at the date of death or the last date the participant was known to be alive or the data cutoff date, whichever is earlier.|Baseline until start of subsequent antineoplastic therapy (up to 4.7 years)|The ITT population included all participants who were randomized.||months||95% Confidence Interval|Median
826870|NCT01193244|Secondary|Time to Docetaxel Chemotherapy|Time to docetaxel based chemotherapy is defined as the time from randomization to the start of docetaxel based chemotherapy for prostate cancer, regardless of whether the participant received concurrent orteronel or not. Deaths due to disease progression prior to Docetaxel based chemotherapy were considered as events.|Baseline until start of docetaxel chemotherapy (up to 4.7 years)|ITT population included all participants who were randomized.||months||95% Confidence Interval|Median
826871|NCT01193244|Secondary|Time to PSA Progression|Time to PSA progression was defined as time from randomization to a PSA increase of 25 percent and PSA rise of at least 2 nanogram per milliliter (ng/mL) above the lowest value observed post baseline or, if no PSA decline occurred post baseline, compared to baseline PSA.|Baseline until the final on treatment assessment or until end of short term follow-up following discontinuation of treatment, whichever occurred later (approximately up to 4.7 years)|ITT population included all participants who were randomized.||months||95% Confidence Interval|Median
826872|NCT01193244|Secondary|Percentage of Participants Achieving PSA90 Response at Any Time During the Study|The PSA90 is defined as a decline of PSA by 90 percent from baseline.|Cycle: 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34 and 37|ITT population where baseline and post-baseline assessments were available. The ITT population included all participants who were randomized.||percentage of participants||95% Confidence Interval|Number
826873|NCT01193244|Secondary|Percentage of Participants Achieving 90 Percent Reduction From Baseline in Prostate Specific Antigen (PSA90 Response) at Week 12|The PSA90 is defined as a decline of PSA by 90 percent from baseline.|Week 12|ITT population included all participants who were randomized.||percentage of participants|||Number
826874|NCT01193244|Secondary|Percentage of Participants Achieving PSA50 Response at Any Time During the Study|The PSA50 is defined as a decline of PSA by 50 percent from baseline.|Cycle: 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34 and 37|ITT population where baseline and post-baseline assessments were available. The ITT population included all participants who were randomized.||percentage of participants||95% Confidence Interval|Number
826875|NCT01193244|Secondary|Time to SRE|Time to SRE is defined as the time from randomization to SRE, or death due to any cause, whichever comes first. SRE is defined as a fracture or spinal cord compression or the need for radiation or surgery at the site of a prostate cancer metastatic lesion that is substantiated by radiographic or pathologic evidence.|Baseline up to EOT (Cycle 61 Day 58)|The ITT population included all participants who were randomized.||months||95% Confidence Interval|Median
826876|NCT01193244|Secondary|Percentage of Participants With Skeletal Related Events (SRE)|Skeletal related (SRE) event is defined as a fracture or spinal cord compression or the need for radiation or surgery at the site of a prostate cancer metastatic lesion that is substantiated by radiographic or pathologic evidence.|Baseline up to EOT (approximately up to 4.7 years)|The ITT population included all participants who were randomized.||percentage of participants||95% Confidence Interval|Number
826877|NCT01193244|Secondary|Number of Participants With TEAEs Categorized Into Investigations Related to Chemistry, Hematology or Coagulation||Baseline up to 30 days or EOT whichever is later (approximately up to Cycle 61 Day 58)|Safety population included all participants who received at least 1 dose of any study drug.||participants|||Number
826878|NCT01193244|Secondary|Worst Change From Baseline Over Time in Cardiac Ejection Fraction|Worst change was defined as the worst overall change that occurred in cardiac ejection fraction at any measured time point.|Baseline up to 30 days or EOT whichever is later (approximately up to Cycle 61 Day 58)|Safety population where baseline and post-baseline assessments were available. Safety population included all participants who received at least 1 dose of any study drug.||percent ejection fraction||Standard Deviation|Mean
826879|NCT01193244|Secondary|Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings||Baseline up to EOT (Cycle 61 Day 58)|Safety population included all participants who received at least 1 dose of any study drug.||participants|||Number
827536|NCT01207687|Secondary|Incidence of Serious or Life Threatening Toxicities|The number of patients with serious or life threatening toxicities (CTCAE grade 3 or above)|Up to 6 months post-treatment|Participants evaluated for serious or life threatening toxicities||Participants|||Count of Participants
826880|NCT01193244|Secondary|Number of Participants With Worst Change From Baseline in Eastern Co-operative Oncology Group (ECOG) Performance Status|ECOG assessed participant's performance status on 5 point scale: 0=Fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (>50 percent of waking hours [hrs]), capable of all self care, unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair >50 percent of waking hrs; 4=completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=dead. Worst change was defined as the worst overall change that occurred in ECOG status at any measured time point during the treatment period.|Baseline until EOT (approximately up to 4.7 years)|Safety population where baseline and post-baseline assessments were available. Safety population included all participants who received at least 1 dose of any study drug.||participants|||Number
826881|NCT01193244|Secondary|Number of Participants With TEAEs Related to Weight||Baseline up to 30 days after last dose of study drug (Cycle 61 Day 58)|Safety population included all participants who received at least 1 dose of any study drug.||participants|||Number
826882|NCT01193244|Secondary|Number of Participants With TEAEs Related to Vital Signs||Baseline up to 30 days after last dose of study drug (Cycle 61 Day 58)|Safety population included all participants who received at least 1 dose of any study drug.||participants|||Number
826883|NCT01193244|Secondary|Number of Participants With Treatment-emergent Adverse Events Greater Than or Equal to (>=) Grade 3|Grade 3 (Severe) events=unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4 (Life-threatening) events caused participant to be in imminent danger of death. Grade 5 (Death) events=death related to an AE.|Baseline up to 30 days after last dose of study drug (Cycle 61 Day 58)|Safety population included all participants who received at least 1 dose of any study drug.||participants|||Number
826884|NCT01193244|Secondary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)||Baseline up to 30 days after last dose of study drug (Cycle 61 Day 58)|Safety population included all participants who received at least 1 dose of any study drug.||participants|||Number
826885|NCT01193244|Secondary|Time to Pain Progression|Time to pain progression was defined as the time from participant randomization to the first assessment date of pain progression. Pain progression was defined as the occurrence of 1 of the following and confirmed by an additional assessment, at least 3 weeks but not more than 5 weeks later: The brief pain inventory-short form (BPI-SF) worst pain score was >=4 with a >=2 point increase over baseline in BPI-SF worst pain score with stable or increased analgesic use; The BPI-SF worst pain score was >=4 but not less than baseline with new or increased (relative to baseline) Step II or Step III analgesic use; The BPI-SF worst pain score was <=3 but not less than baseline with new or increased (relative to baseline) Step III analgesic use. BPI-SF was an 11-item questionnaire, designed to assess severity and impact of pain on daily functions. Total score ranged from 0 to 100 with lower scores being indicative of less pain or pain interference.|Baseline until End of treatment (EOT) (approximately up to 4.7 years)|ITT population included all participants who were randomized.||months||95% Confidence Interval|Median
826886|NCT01193244|Secondary|Percentage of Participants With Favorable Circulating Tumor Cell Count (CTC) Levels at Week 12|A favorable CTC count was defined as less than <5 counts per 7.5 milliliter (mL) in whole blood. An unfavorable CTC count was defined as greater than or equal to (>=) 5 counts/7.5 mL in whole blood.|Week 12|ITT population included all participants who were randomized.||percentage of participants||95% Confidence Interval|Number
826887|NCT01193244|Secondary|Percentage of Participants Achieving 50 Percent Reduction From Baseline in Prostate Specific Antigen (PSA50) Response at Week 12|The PSA50 is defined as a decline of at least 50 percent (%) from baseline.|Week 12|ITT population included all participants who were randomized.||percentage of participants||95% Confidence Interval|Number
826888|NCT01193244|Primary|Overall Survival|Overall survival was calculated from the date of participant randomization to the date of participant death due to any cause. Participants without documentation of death at time of the analysis were censored as of the date the participant was last known to be alive, or the data cutoff date, whichever was earlier.|Baseline until death (up to 4.7 years)|ITT population included all participants who were randomized.||months||95% Confidence Interval|Median
826889|NCT01193244|Primary|Radiographic Progression-free Survival (rPFS)|rPFS was defined as the time from randomization to the first objective evidence of radiographic disease progression assessed by independent central radiology review or death due to any cause, whichever occurred first. Radiographic disease progression was evaluated by computerized tomography (CT) scan or magnetic resonance imaging (MRI) and radionuclide bone scans at regularly scheduled visits. Radiographic disease progression in bone required a confirmatory scan. Radiographic disease progression in soft tissue did not require a confirmatory scan for purposes of analysis. Radiographic disease progression was evaluated by independent central radiology review using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 for soft tissue disease and Prostate Cancer Working Group (PCWG2) guidelines for bone disease. Participants who did not reach the endpoint were censored at their last assessment.|Baseline until radiographic disease progression or death, whichever occurred first (approximately up to 4.7 years)|ITT population included all participants who were randomized.||months||95% Confidence Interval|Median
826890|NCT01193283|Primary|Blood Counts and Adverse Event Profile After 6 Months of Treatment.|The safety endpoint will be toxicity profile after 6 months of treatment. The efficacy endpoint is complete response rate at 6 months, with complete response defined as blood counts no longer meeting the standard criteria for severe pancytopenia in severe aplastic anemia.|6 months|||participants|||Number
826891|NCT01193335|Secondary|Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 2 Years After Toddler Dose|Percentage of participants achieving OPA titer >=LLOQ for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) determined in blood samples of all participants was presented. Exact 2-sided CI based on observed proportion of participants. LLOQ for each serotype: 1=18; 3=12; 4=21; 5=29; 6A=37; 6B=43; 7F=210; 9V=345; 14=35; 18C=31; 19A=18; 19F=48; 23F=13.|2 Years After Toddler Dose|Evaluable Toddler Immunogenicity Population. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure during specified follow-up period and 'n' signifies participants with a determinate OPA titer to the given serotype during specified follow-up period for each arm, respectively.||percentage of participants||95% Confidence Interval|Number
826892|NCT01193335|Secondary|Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Year After Toddler Dose|Percentage of participants achieving OPA titer >=LLOQ for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) determined in blood samples of all participants was presented. Exact 2-sided CI based on observed proportion of participants. LLOQ for each serotype: 1=18; 3=12; 4=21; 5=29; 6A=37; 6B=43; 7F=210; 9V=345; 14=35; 18C=31; 19A=18; 19F=48; 23F=13.|1 Year After Toddler Dose|Evaluable Toddler Immunogenicity Population. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure during specified follow-up period and 'n' signifies participants with a determinate OPA titer to the given serotype during specified follow-up period for each arm, respectively.||percentage of participants||95% Confidence Interval|Number
826893|NCT01193335|Secondary|Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Toddler Dose|Percentage of participants achieving OPA titer >=LLOQ for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) determined in blood samples of all participants was presented. Exact 2-sided CI based on observed proportion of participants. LLOQ for each serotype: 1=18; 3=12; 4=21; 5=29; 6A=37; 6B=43; 7F=210; 9V=345; 14=35; 18C=31; 19A=18; 19F=48; 23F=13.|1 Month After Toddler Dose|Evaluable Toddler Immunogenicity Population. Here 'n' signifies participants with a determinate OPA titer to the given serotype during specified follow-up period for each arm, respectively.||percentage of participants||95% Confidence Interval|Number
826894|NCT01193335|Secondary|Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) Before Toddler Dose|Percentage of participants achieving OPA titer >=LLOQ for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) determined in blood samples of all participants was presented. Exact 2-sided CI based on observed proportion of participants. LLOQ for each serotype: 1=18; 3=12; 4=21; 5=29; 6A=37; 6B=43; 7F=210; 9V=345; 14=35; 18C=31; 19A=18; 19F=48; 23F=13.|Before Toddler Dose (pre-vaccination)|Evaluable Toddler Immunogenicity Population. Here ‘n’ signifies participants with a determinate OPA antibody titer to the given serotype for each arm respectively.||percentage of participants||95% Confidence Interval|Number
826895|NCT01193335|Secondary|Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series|Percentage of participants achieving OPA titer >=LLOQ for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) determined in blood samples of all participants was presented. Exact 2-sided CI based on observed proportion of participants. LLOQ for each serotype: 1=18; 3=12; 4=21; 5=29; 6A=37; 6B=43; 7F=210; 9V=345; 14=35; 18C=31; 19A=18; 19F=48; 23F=13.|1 Month After Infant Series|Evaluable Infant Immunogenicity Population. Here ‘n’ signifies participants with a determinate OPA antibody titer to the given serotype for each arm respectively.||percentage of participants||95% Confidence Interval|Number
826896|NCT01193335|Secondary|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 2 Years After Toddler Dose|Antibody-mediated serum OPA against the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) was measured using a pneumococcal OPA assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs).|2 Years After Toddler Dose|Evaluable Toddler Immunogenicity Population. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure during specified follow-up period and 'n' signifies participants with a determinate OPA titer to the given serotype during specified follow-up period for each arm, respectively.||titer||95% Confidence Interval|Geometric Mean
826897|NCT01193335|Secondary|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Year After Toddler Dose|Antibody-mediated serum OPA against the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) was measured centrally using a pneumococcal OPA assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs).|1 Year After Toddler Dose|Evaluable Toddler Immunogenicity Population. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure during specified follow-up period and 'n' signifies participants with a determinate OPA titer to the given serotype during specified follow-up period for each arm, respectively.||titer||95% Confidence Interval|Geometric Mean
826898|NCT01193335|Secondary|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Toddler Dose|Antibody-mediated serum OPA against the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) was measured centrally using a pneumococcal OPA assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs).|1 Month After Toddler Dose|Evaluable Toddler Immunogenicity Population. Here ‘n’ signifies participants with a determinate OPA titer to the given serotype for each arm respectively.||titer||95% Confidence Interval|Geometric Mean
826899|NCT01193335|Secondary|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before Toddler Dose|Antibody-mediated serum OPA against the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) was measured centrally using a pneumococcal OPA assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs).|Before the toddler dose (pre-vaccination)|Evaluable Toddler Immunogenicity Population. Here 'n’ signifies participants with a determinate OPA titer to the given serotype for each arm respectively.||titer||95% Confidence Interval|Geometric Mean
826931|NCT01193348|Secondary|Pharmacokinetics (PK) and Pharmacodynamics (PD); Minimum and Maximum Blood Concentration (Body Weight Cohort 20 - <30kg)||Induction Phase was between 1 and 4 weeks in length depending on patient weight cohort. Maintenance Phase was started either 2 weeks or 3 weeks after induction phase depending on patient weight cohort|PK parameters Cmin and Cmax were estimated using a population PK model developed from the observed PK concentration data||micrograms/mL||Standard Deviation|Mean
826900|NCT01193335|Secondary|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Infant Series|Antibody-mediated serum OPA against the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) was measured centrally using a pneumococcal OPA assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs).|1 Month After Infant Series|Evaluable Infant Immunogenicity Population. Here n’ signifies participants with a determinate OPA titer to the given serotype for each arm respectively.||titer||95% Confidence Interval|Geometric Mean
826901|NCT01193335|Secondary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose: Group 1A, 1B, 1C|The persistence of the antibody response induced by 13vPnC was described by geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A). GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|2 Years After Toddler Dose|Evaluable Toddler Immunogenicity Population. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure during specified follow-up period and 'n' signifies participants with a determinate IgG concentration to the given serotype during specified follow-up period for each arm, respectively.||mcg/mL||95% Confidence Interval|Geometric Mean
826902|NCT01193335|Secondary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose: Group 1A, 1B, 1C|The persistence of the antibody response induced by 13vPnC was described by geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A). GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|1 Year After Toddler Dose|Evaluable Toddler Immunogenicity Population. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure during specified follow-up period and 'n' signifies participants with a determinate IgG concentration to the given serotype during specified follow-up period for each arm, respectively.||mcg/mL||95% Confidence Interval|Geometric Mean
826903|NCT01193335|Secondary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose: Group 1A, 1B, 1C|Geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Here 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.|1 Month After Toddler Dose|Evaluable Toddler Immunogenicity Population.||mcg/mL||95% Confidence Interval|Geometric Mean
826904|NCT01193335|Secondary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose: Group 1A, 1B, 1C|Geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Here 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.|Before Toddler Dose (pre-vaccination)|Evaluable Toddler Immunogenicity Population.||mcg/mL||95% Confidence Interval|Geometric Mean
826905|NCT01193335|Secondary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Infant Series: Group 1A, 1B, 1C|Geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Here 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.|1 Month After Infant Series|Evaluable Infant Immunogenicity Population.||mcg/mL||95% Confidence Interval|Geometric Mean
826906|NCT01193335|Secondary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose|The persistence of the antibody response induced by 13vPnC was described by geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A). GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|2 Years After Toddler Dose|Evaluable Toddler Immunogenicity Population. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure during specified follow-up period and 'n' signifies participants with a determinate IgG concentration to the given serotype during specified follow-up period for each arm, respectively.||mcg/mL||95% Confidence Interval|Geometric Mean
826932|NCT01193348|Secondary|Pharmacokinetics (PK) and Pharmacodynamics (PD); Minimum and Maximum Blood Concentration (Body Weight Cohort 10 - <20kg) N=7||Induction Phase was between 1 and 4 weeks in length depending on patient weight cohort.Maintenance Phase was started 1 week after induction phase and dosing of eculizumab administration was every 2 weeks or every 3 weeks depending on patient weight cohort|PK parameters Cmin and Cmax were estimated using a population PK model developed from the observed PK concentration data||micrograms/mL||Standard Deviation|Mean
826907|NCT01193335|Secondary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose|The persistence of the antibody response induced by 13vPnC was described by geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A). GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|1 Year After Toddler Dose|Evaluable Toddler Immunogenicity Population. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure during specified follow-up period and 'n' signifies participants with a determinate IgG concentration to the given serotype during specified follow-up period for each arm, respectively.||mcg/mL||95% Confidence Interval|Geometric Mean
826908|NCT01193335|Secondary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose|Geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Here 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.|1 Month After Toddler Dose|Evaluable Toddler Immunogenicity Population.||mcg/mL||95% Confidence Interval|Geometric Mean
826909|NCT01193335|Secondary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose|Geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Before Toddler Dose (pre-vaccination)|Evaluable Toddler Immunogenicity Population. Here 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.||mcg/mL||95% Confidence Interval|Geometric Mean
826910|NCT01193335|Secondary|Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level >=0.35 mcg/mL 1 Month After Toddler Dose: Group 1A, 1B, 1C|Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. Exact 2-sided CI based on the observed proportion of participants.|1 month after the toddler dose|Evaluable Toddler Immunogenicity Population. Here ‘n’ signifies participants with a determinate IgG antibody concentration to the given serotype for each arm, respectively.||percentage of participants||95% Confidence Interval|Number
826911|NCT01193335|Secondary|Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Toddler Dose|Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. Exact 2-sided CI based on the observed proportion of participants. Here ‘n’ signifies participants with a determinate IgG antibody concentration to the given serotype for each arm, respectively.|1 month after the toddler dose|Evaluable Toddler Immunogenicity Population included eligible participants who received all the assigned vaccinations (Infant Dose 1, 2, 3 and toddler dose), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, received no prohibited vaccines, and had no major protocol violations.||percentage of participants||95% Confidence Interval|Number
826912|NCT01193335|Secondary|Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After Infant Series: Group 1A, 1B, 1C|Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95 % CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. Exact 2-sided CI based on the observed proportion of participants. Here 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.|1 Month After Infant Series|Evaluable infant immunogenicity population included eligible participants who received all the assigned vaccinations (Infant Dose 1, 2 and 3), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, received no prohibited vaccines, and had no major protocol violations.||percentage of participants||95% Confidence Interval|Number
826913|NCT01193335|Secondary|Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Toddler Pre-Dose to 1 Month After Toddler Dose|GMFR for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) from before 13vPnC toddler dose to 1 month after 13vPnC toddler dose were computed using the logarithmically transformed assay results. CIs for GMFR were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the fold rises. GMFRs were calculated using all participants with available data from both before 13vPnC toddler dose and after 13vPnC toddler dose blood draws.|Before 13vPnC Toddler Dose (pre-vaccination), 1 month after 13vPnC Toddler Dose|Evaluable Toddler Immunogenicity Population. Here ‘n’ signifies participants with a determinate IgG antibody concentration to the given serotype for each arm, respectively.||fold rise||95% Confidence Interval|Geometric Mean
826933|NCT01193348|Secondary|Pharmacokinetics (PK) and Pharmacodynamics (PD); Minimum and Maximum Blood Concentration (Body Weight Cohort 5 - <10kg) N=3||Induction Phase was between 1 and 4 weeks in length depending on patient weight cohort.Maintenance Phase was started 1 week after induction phase and dosing of eculizumab administration was every 2 weeks or every 3 weeks depending on patient weight cohort|PK parameters Cmin and Cmax were estimated using a population PK model developed from the observed PK concentration data||micrograms/mL||Standard Deviation|Mean
826914|NCT01193335|Primary|Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): 2-Year Follow-up After Toddler Dose|An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|1-year follow-up after toddler dose to 2-year follow-up after toddler dose|Safety population for 2-year follow-up after toddler dose included all participants who received 13vPnC toddler dose and had safety data available during specified follow-up period.||percentage of participants|||Number
826915|NCT01193335|Primary|Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): 1-Year Follow-up After Toddler Dose|An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|1 month after toddler dose up to 1-year follow-up|Safety population for 1-year follow-up after toddler dose included all participants who received 13vPnC toddler dose and had safety data available during specified follow-up period.||percentage of participants|||Number
826916|NCT01193335|Primary|Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): Toddler Dose|An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Toddler dose up to 1 Month after toddler dose|Safety population for toddler dose included all participants who received 13vPnC toddler dose.||percentage of participants|||Number
826917|NCT01193335|Primary|Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): After Infant Series|An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|1 Month after Dose 3 of the infant series up to toddler dose|Safety population for infant series included all participants who received at least 1 dose of 13vPnC during infant series.||percentage of participants|||Number
826918|NCT01193335|Primary|Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): Infant Series|An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Dose 1 up to 1 month after Dose 3 (infant series)|Safety population for infant series included all participants who received at least 1 dose of 13vPnC during infant series.||percentage of participants|||Number
826919|NCT01193335|Primary|Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Toddler Dose|Systemic events (fever >=38 degrees Celsius [C], decreased appetite, increased sleep, and irritability or decreased sleep) and use of antipyretic medication were reported using an electronic diary. Decreased appetite was scaled as Any; Mild (loss of appetite but no decreased oral intake); Moderate (decreased oral intake); Severe (refusal to feed). Increased sleep was scaled as Any; Mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (disabling not interested in usual daily activity). Irritability or decreased sleep was scaled as Any; Mild (easily consolable); Moderate (requiring increased attention); Severe (inconsolable; crying that cannot be comforted). Participants may be represented in more than 1 category.|Within 7 days after the toddler dose|Safety population for Toddler Dose: all participants who received 13vPnC Toddler Dose. Here 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any event and 'n'=participants reporting yes for at least 1 day or no for all days for specified event for each group, respectively.||percentage of participants|||Number
826920|NCT01193335|Primary|Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 3 Infant Series|Systemic events (fever >=38 degrees Celsius [C], decreased appetite, increased sleep, and irritability or decreased sleep) and use of antipyretic medication were reported using an electronic diary. Decreased appetite was scaled as Any; Mild (loss of appetite but no decreased oral intake); Moderate (decreased oral intake); Severe (refusal to feed). Increased sleep was scaled as Any; Mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (disabling not interested in usual daily activity). Irritability or decreased sleep was scaled as Any; Mild (easily consolable); Moderate (requiring increased attention); Severe (inconsolable; crying that cannot be comforted). Participants may be represented in more than 1 category.|Within 7 days after Dose 3 of the infant series|Safety population for Dose 3 infant series: all participants who received 13vPnC Dose 3. Here 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any event and 'n'=participants reporting yes for at least 1 day or no for all days for specified event for each group, respectively.||percentage of participants|||Number
826928|NCT01193335|Primary|Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After Infant Series|Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95 percent (%) confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. Exact 2-sided CI based on the observed proportion of participants. Here 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.|1 month after the infant series|Evaluable infant immunogenicity population included eligible participants who received all the assigned vaccinations (Infant Dose 1, 2 and 3), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, received no prohibited vaccines, and had no major protocol violations.||percentage of participants||95% Confidence Interval|Number
826921|NCT01193335|Primary|Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 2 Infant Series|Systemic events (fever >=38 degrees Celsius [C], decreased appetite, increased sleep, and irritability or decreased sleep) and use of antipyretic medication were reported using an electronic diary. Decreased appetite was scaled as Any; Mild (loss of appetite but no decreased oral intake); Moderate (decreased oral intake); Severe (refusal to feed). Increased sleep was scaled as Any; Mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (disabling not interested in usual daily activity). Irritability or decreased sleep was scaled as Any; Mild (easily consolable); Moderate (requiring increased attention); Severe (inconsolable; crying that cannot be comforted). Participants may be represented in more than 1 category.|Within 7 days after Dose 2 of the infant series|Safety population for Dose 2 infant series: all participants who received 13vPnC Dose 2. Here 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any event and 'n'=participants reporting yes for at least 1 day or no for all days for specified event for each group, respectively.||percentage of participants|||Number
826922|NCT01193335|Primary|Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 1 Infant Series|Systemic events (fever >=38 degrees Celsius [C], decreased appetite, increased sleep, and irritability or decreased sleep) and use of antipyretic medication were reported using an electronic diary. Decreased appetite was scaled as Any; Mild (loss of appetite but no decreased oral intake); Moderate (decreased oral intake); Severe (refusal to feed). Increased sleep was scaled as Any; Mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (disabling not interested in usual daily activity). Irritability or decreased sleep was scaled as Any; Mild (easily consolable); Moderate (requiring increased attention); Severe (inconsolable; crying that cannot be comforted). Participants may be represented in more than 1 category.|Within 7 days after Dose 1 of the infant series|Safety population for Dose 1 infant series: all participants who received 13vPnC Dose 1. Here 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any event and 'n'=participants reporting yes for at least 1 day or no for all days for specified event for each group, respectively.||percentage of participants|||Number
826923|NCT01193335|Primary|Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Toddler Dose|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurts if gently touched with no crying); Moderate (hurts if gently touched with crying); Severe (causes limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.|Within 7 days after the toddler dose|Safety population for Toddler Dose: all participants who received 13vPnC Toddler Dose. Here 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction.'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.||percentage of participants|||Number
826924|NCT01193335|Primary|Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 3 Infant Series|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurts if gently touched with no crying); Moderate (hurts if gently touched with crying); Severe (causes limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.|Within 7 days after Dose 3 of the infant series|Safety population for Dose 3 infant series: all participants who received 13vPnC Dose 3.Here 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction.'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.||percentage of participants|||Number
826925|NCT01193335|Primary|Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 2 Infant Series|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurts if gently touched with no crying); Moderate (hurts if gently touched with crying); Severe (causes limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.|Within 7 days after Dose 2 of the infant series|Safety population for Dose 2 infant series: all participants who received 13vPnC Dose 2.Here 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction.'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.||percentage of participants|||Number
826926|NCT01193335|Primary|Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 1 Infant Series|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurts if gently touched with no crying); Moderate (hurts if gently touched with crying); Severe (causes limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.|Within 7 days after Dose 1 of the infant series|Safety population for Dose 1 infant series: all participants who received13vPnC Dose 1. Here 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction.'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.||percentage of participants|||Number
826927|NCT01193335|Primary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series|Antibody geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|1 month after the infant series|Evaluable infant immunogenicity population. Here ‘n’ signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.||mcg/mL||95% Confidence Interval|Geometric Mean
826934|NCT01193348|Secondary|Platelet Count Change From Baseline to 52 Weeks||Through 52 Weeks|Change from baseline platelet counts were analyzed for the ITT population using a repeated measures ANOVA model. The estimated LS means of change from baseline at each post-baseline visit alongside with 95% CIs and P-values were calculated, as were the parameter estimates for the covariates and their associated P-values.||10^9 cells/L||95% Confidence Interval|Least Squares Mean
826935|NCT01193348|Secondary|Proportion of Patients With Estimated Glomerular Filtration Rate (eGFR) Improvement|Proportion of Patients with Estimated Glomerular Filtration Rate (eGFR) Improvement was determined and defined as an increase in eGFR by ≥ 15 mL/min/1.73m2 from baseline, sustained for at least two consecutive measurements obtained at least four weeks apart.|Through End of Study, Median Exposure 55 Weeks|The tabulations of the proportions of patients with eGFR Improvement through end of study were performed for the ITT population. The number of patients with response and responder rate, along with an exact two-sided 95% CI were summarized.||Percentage of Participants||95% Confidence Interval|Number
826936|NCT01193348|Secondary|Proportion of Patients With Platelet Count Normalization|Proportion of Patients with Platelet Count Normalization through end of study was determined and defined as the platelet count observed to be ≥ 150 x 109/L on at least two consecutive measurements which span a period of at least four weeks|Through End of Study, Median Exposure 55 Weeks|The tabulations of the proportions of patients with Platelet Count Normalization through end of study were performed for the ITT population. The number of patients with response and responder rate, along with an exact two-sided 95% CI were summarized.||Percentage of Participants||95% Confidence Interval|Number
826937|NCT01193348|Secondary|Proportion of Patients With Complete Hematologic Response|Proportion of Patients with Complete Hematologic response through end of study was determined and defined by normalization of platelet count and LDH sustained for at least two consecutive measurements obtained at least four weeks apart.|Through End of Study, Median Exposure 55 Weeks|The tabulations of the proportions of patients with Complete Hematologic Response through end of study were performed for the ITT population. The number of patients with response and responder rate, along with an exact two-sided 95% CI were summarized.||Percentage of Participants||95% Confidence Interval|Number
826938|NCT01193348|Secondary|Proportion of Patients With Complete TMA Response|Proportion of Patients with Complete TMA response was determined and defined by normalization of hematological parameters (platelet count and LDH) and ≥ 25% improvement in serum creatinine from baseline which was sustained for at least two consecutive measurements obtained at least four weeks apart).|Through End of Study, Median Exposure 55 Weeks|The tabulations of the proportions of patients with Complete TMA Response through end of study were performed for the ITT population. Exact binomial two-sided 95% CI using the Clopper-Pearson method for the responder rate was presented.||Percentage of Participants||95% Confidence Interval|Number
826939|NCT01193348|Secondary|Platelet Count Change From Baseline to 26 Weeks||Through 26 weeks|Change from baseline platelet counts were analyzed for the ITT population using a repeated measures ANOVA model. The estimated LS means of change from baseline at each post-baseline visit alongside with 95% CIs and P-values were calculated, as were the parameter estimates for the covariates and their associated P-values.||10^9 cells/L||95% Confidence Interval|Least Squares Mean
826940|NCT01193348|Secondary|Proportion of Patients With Estimated Glomerular Filtration Rate (eGFR) Improvement|Proportion of Patients with Estimated Glomerular Filtration Rate (eGFR) Improvement was determined and defined as an increase in eGFR by ≥ 15 mL/min/1.73m2 from baseline, sustained for at least two consecutive measurements obtained at least four weeks apart.|Through 26 weeks|The tabulations of the proportions of patients with Estimated Glomerular Filtration Rate (eGFR) Improvement through 26 weeks were performed for the ITT population. The number of patients with response and responder rate, along with an exact two-sided 95% CI were summarized.||Percentage of Participants||95% Confidence Interval|Number
826941|NCT01193348|Secondary|Proportion of Patients With Platelet Count Normalization|Proportion of Patients with Platelet Count Normalization through 26 weeks of treatment was determined and defined as the platelet count observed to be ≥ 150 x 109/L on at least two consecutive measurements which span a period of at least four weeks.|Through 26 weeks|The tabulations of the proportions of patients with Platelet Count Normalization through 26 weeks were performed for the ITT population. The number of patients with response and responder rate, along with an exact two-sided 95% CI were summarized.||Percentage of Participants||95% Confidence Interval|Number
826942|NCT01193348|Secondary|Proportion of Patients With Complete Hematologic Response|Proportion of Patients with Complete Hematologic response through 26 weeks of treatment was determined and defined by normalization of platelet count and LDH sustained for at least two consecutive measurements obtained at least four weeks apart.|Through 26 weeks|The tabulations of the proportions of patients with Complete Hematologic Response through 26 weeks were performed for the ITT population. The number of patients with response and responder rate, along with an exact two-sided 95% CI were summarized.||Percentage of Participants||95% Confidence Interval|Number
826943|NCT01193348|Primary|Proportion of Patients With Complete TMA Response|Proportion of Patients with Complete TMA response was determined and defined by normalization of hematological parameters (platelet count and LDH) and ≥ 25% improvement in serum creatinine from baseline which was sustained for at least two consecutive measurements obtained at least four weeks apart).|Through 26 weeks|The tabulations of the proportions of patients with Complete TMA Response through 26 weeks were performed for the ITT population. Exact binomial two-sided 95% CI using the Clopper-Pearson method for the responder rate was presented.||Percentage of Participants||95% Confidence Interval|Number
826944|NCT01193556|Secondary|Operative Time, Estimated Blood Loss (EBL), Diet Volume and Activity Level||1-2 weeks post-operatively|An integrity audit found that the data for this study could not be analyzed owing to unverifiable source documentation.|||||
826945|NCT01193556|Primary|Post-operative Pain|The primary outcome measure will be pain in each treatment group, as measured by visual analog scale twice daily in the 10 day period directly following surgery.|10 days immediately following surgery|An integrity audit found that the data for this study could not be analyzed owing to unverifiable source documentation.|||||
826967|NCT01193608|Other Pre-specified|Change From Baseline in CSF Amyloid-beta x-42 Concentration at Week 32 for AAB-003 8 mg/kg and Placebo Groups||Baseline and Week 32|The CSF analysis set consisted of participants in the AAB-003 8 mg/kg cohort who had provided sufficient CSF samples at Baseline and Week 32 to allow for assaying of both samples, and who had no occurrence of VE.||pg/mL||Standard Deviation|Mean
826946|NCT01193582|Secondary|GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values at 12 Months After the Last Dose.|GMFRs for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from pre-vaccination to 12- month follow-up were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers.|Pre-vaccination to 12 months after the last dose|Evaluable immunogenicity population consisted subjects who had received all , assigned vaccination(s), had blood drawn within required time frame for 12 month follow-up blood draw visit, had at least 1 valid and determinate assay result, had received no prohibited vaccines, and had no major protocol violations.||Fold rise||95% Confidence Interval|Geometric Mean
826947|NCT01193582|Secondary|Antibody Concentrations Against the 7 Pneumococcal Serotypes Contained in Prevenar at 12 Months After the Last Dose.|Serotype-specific Pneumococcal IgG antibody GMC 12 months after the last dose for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.|12 months after the last dose|Evaluable immunogenicity population consisted subjects who had received all , assigned vaccination(s), had blood drawn within required time frame for 12 month follow-up blood draw visit, had at least 1 valid and determinate assay result, had received no prohibited vaccines, and had no major protocol violations.||μg/mL||95% Confidence Interval|Geometric Mean
826948|NCT01193582|Secondary|GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 3.|GMFRs for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from pre-vaccination to post-vaccination were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers.|Pre-vaccination to 1 month after first dose of Prevenar in Group 3|Evaluable immunogenicity population consisted of eligible participants in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations.||Fold rise||95% Confidence Interval|Geometric Mean
826949|NCT01193582|Secondary|Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the First Dose in Group 3|Serotype-specific Pneumococcal IgG antibody GMC one month after the first dose in Group 3 for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.|1 month after first dose of Prevenar in Group 3|Evaluable immunogenicity population consisted of eligible participants in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations.||μg/mL||95% Confidence Interval|Geometric Mean
826950|NCT01193582|Secondary|GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 2.|GMFRs for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from pre-vaccination to post-vaccination were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers.|Pre-vaccination to 1 month after second dose of Prevenar in Group 2|Evaluable immunogenicity population consisted of eligible participants in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations.||Fold rise||95% Confidence Interval|Geometric Mean
826951|NCT01193582|Secondary|Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the Second Dose in Group 2|Serotype-specific Pneumococcal IgG antibody GMC 1 month after the second dose in Group 2 for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.|1 month after second dose of Prevenar in Group 2|Evaluable immunogenicity population consisted of eligible participants in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations.||μg/mL||95% Confidence Interval|Geometric Mean
826952|NCT01193582|Secondary|Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 1.|GMFRs for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from pre-vaccination to post-vaccination were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers.|Pre-vaccination to 1 month after third dose of Prevenar in Group 1|Evaluable immunogenicity population consisted of eligible participants in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations.||Fold rise||95% Confidence Interval|Geometric Mean
826953|NCT01193582|Secondary|Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the Third Dose in Group 1|Serotype-specific Pneumococcal IgG antibody GMC one month after the third dose in Group 1 for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.|1 month after third dose of Prevenar in Group 1|Evaluable immunogenicity population consisted of eligible participants in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations.||μg/mL||95% Confidence Interval|Geometric Mean
827182|NCT01202253|Secondary|Percentage of Participants With Prior Colonization With Candida by Species|Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 by standard calculations (outside the valid range of 0 to 100).|Baseline|Full analysis set included all participants who met the defined eligibility criteria.||percentage of participants||95% Confidence Interval|Number
826954|NCT01193582|Primary|Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at Baseline in Each Group|Serotype-specific Pneumococcal IgG antibody GMC at baseline for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.|Baseline|Evaluable immunogenicity population consisted of eligible participants in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations.||μg/mL||95% Confidence Interval|Geometric Mean
826955|NCT01193582|Primary|Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar|Serotype-specific Pneumococcal Immunoglobulin G (IgG) antibody geometric mean concentration (GMC) after 1 month of last dose for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.|1 month after last dose in each group|Evaluable immunogenicity population consisted of eligible participants in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations.||μg/mL||95% Confidence Interval|Geometric Mean
826956|NCT01193608|Other Pre-specified|Plasma Decay Half-Life (t1/2) for Amyloid-Beta x-40||Baseline; Day 2 (24 hours post start of infusion); Weeks 1, 6, and 13 (pre-dose, 1 hour [end of infusion]), Week 26 (pre-dose, 1 hour [end of infusion], 1.5, 2, 4, 6, and 24 hours post start of infusion), and Weeks 32 and 39.|All randomized participants who received at least one infusion of study medication, had a Baseline PD parameter assessment, at least one post-dose PD parameter assessment, and who had available data for t1/2. No participants had available data for t1/2 in AAB-003 8 mg/kg and Placebo Groups.||Day||Standard Deviation|Mean
826957|NCT01193608|Other Pre-specified|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Amyloid-Beta x-40||Weeks 1, 3, 6, 10, 13 (pre-dose, 1 hour [end of infusion]), Week 26 (pre-dose, 1 hour [end of infusion], 1.5, 2, 4, 6, and 24 hours post start of infusion), and Weeks 32 and 39.|All randomized participants who received at least one infusion of study medication, had a Baseline PD parameter assessment, and at least one post-dose PD parameter assessment. n = number of evaluable participants at the corresponding timeframe.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
826958|NCT01193608|Other Pre-specified|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for Amyloid-Beta x-40||Baseline; Day 2 (24 hours post start of infusion); Weeks 1, 6, and 13 (pre-dose, 1 hour [end of infusion]), Week 26 (pre-dose, 1 hour [end of infusion], 1.5, 2, 4, 6, and 24 hours post start of infusion), and Weeks 32 and 39.|All randomized participants who received at least one infusion of study medication, had a Baseline PD parameter assessment, at least one post-dose PD parameter assessment, and who had available data for AUCinf. No participants had available data for AUCinf in AAB-003 8 mg/kg and Placebo Groups.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
826959|NCT01193608|Other Pre-specified|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Amyloid-Beta x-40||Baseline; Day 2 (24 hours post start of infusion); Weeks 1, 6, and 13 (pre-dose, 1 hour [end of infusion]), Week 26 (pre-dose, 1 hour [end of infusion], 1.5, 2, 4, 6, and 24 hours post start of infusion), and Weeks 32 and 39.|All randomized participants who received at least one infusion of study medication, had a Baseline PD parameter assessment, at least one post-dose PD parameter assessment, and who had available data for AUClast.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
826960|NCT01193608|Other Pre-specified|Time to Reach Maximum Observed Plasma Concentration (Tmax) for Amyloid-Beta x-40||Weeks 1, 3, 6, 10, 13 (pre-dose, 1 hour [end of infusion]), Week 26 (pre-dose, 1 hour [end of infusion], 1.5, 2, 4, 6, and 24 hours post start of infusion), and Weeks 32 and 39.|All randomized participants who received at least one infusion of study medication, had a Baseline PD parameter assessment and at least one post-dose PD parameter assessment. n = number of evaluable participants at the corresponding timeframe.||Hours||Full Range|Median
826961|NCT01193608|Other Pre-specified|Maximum Observed Plasma Concentration (Cmax) for Amyloid-Beta x-40||Weeks 1, 3, 6, 10, 13 (pre-dose, 1 hour [end of infusion]), Week 26 (pre-dose, 1 hour [end of infusion], 1.5, 2, 4, 6, and 24 hours post start of infusion), and Weeks 32 and 39.|All randomized participants who received at least one infusion of study medication and have at least one postdose pharmacodynamic (PD) parameter assessment. n = number of evaluable participants at the corresponding timeframe.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
826962|NCT01193608|Other Pre-specified|CSF P-tau Concentration at Baseline and Week 32 for AAB-003 2 mg/kg and 4 mg/kg Groups||Baseline and Week 32|The CSF analysis set consisted of participants in the AAB-003 8 mg/kg cohort who had provided sufficient CSF samples at Baseline and Week 32 to allow for assaying of both samples, and who had no occurrence of VE.||pg/mL||Standard Deviation|Mean
826963|NCT01193608|Other Pre-specified|Change From Baseline in CSF P-tau Concentration at Week 32 for AAB-003 8 mg/kg and Placebo Groups||Baseline and Week 32|The CSF analysis set consisted of participants in the AAB-003 8 mg/kg cohort who had provided sufficient CSF samples at Baseline and Week 32 to allow for assaying of both samples, and who had no occurrence of VE.||pg/mL||Standard Deviation|Mean
826964|NCT01193608|Other Pre-specified|CSF Tau Concentration at Baseline and Week 32 for AAB-003 2 mg/kg and 4 mg/kg Groups||Baseline and Week 32|The CSF analysis set consisted of participants in the AAB-003 8 mg/kg cohort who had provided sufficient CSF samples at Baseline and Week 32 to allow for assaying of both samples, and who had no occurrence of VE.||pg/mL||Standard Deviation|Mean
826965|NCT01193608|Other Pre-specified|Change From Baseline in CSF Tau Concentration at Week 32 for AAB-003 8 mg/kg and Placebo Groups||Baseline and Week 32|The CSF analysis set consisted of participants in the AAB-003 8 mg/kg cohort who had provided sufficient CSF samples at Baseline and Week 32 to allow for assaying of both samples, and who had no occurrence of VE.||pg/mL||Standard Deviation|Mean
826966|NCT01193608|Other Pre-specified|CSF Amyloid-beta x-42 Concentration at Baseline and Week 32 for AAB-003 2 mg/kg and 4 mg/kg Groups||Baseline and Week 32|The CSF analysis set consisted of participants in the AAB-003 8 mg/kg cohort who had provided sufficient CSF samples at Baseline and Week 32 to allow for assaying of both samples, and who had no occurrence of VE.||pg/mL||Standard Deviation|Mean
826968|NCT01193608|Other Pre-specified|CSF Amyloid-beta x-40 Concentration at Baseline and Week 32 for AAB-003 2 mg/kg and 4 mg/kg Groups||Baseline and Week 32|The CSF analysis set consisted of participants in the AAB-003 8 mg/kg cohort who had provided sufficient CSF samples at Baseline and Week 32 to allow for assaying of both samples, and who had no occurrence of VE.||picogram/milliliter (pg/mL)||Standard Deviation|Mean
826969|NCT01193608|Other Pre-specified|Change From Baseline in CSF Amyloid-beta x-40 Concentration at Week 32 for AAB-003 8 mg/kg and Placebo Groups||Baseline and Week 32|The CSF analysis set consisted of participants in the AAB-003 8 mg/kg cohort who had provided sufficient CSF samples at Baseline and Week 32 to allow for assaying of both samples, and who had no occurrence of VE.||picogram/milliliter (pg/mL)||Standard Deviation|Mean
826970|NCT01193608|Other Pre-specified|Cerebrospinal Fluid (CSF) Concentration of AAB-003 at Week 32|Participants enrolled in the 2, 4 and 8 mg/kg cohorts participated in an optional CSF collection. Participants enrolled in the maximum tolerated dose (MTD) cohort were mandatorily collected for CSF.|Week 32 or Early Withdrawal|All randomized and treated participants in the 2, 4 and 8 mg/kg cohorts who consented to the collection of CSF samples.||nanogram/millliter (ng/mL)||Standard Deviation|Mean
826971|NCT01193608|Other Pre-specified|Change From Baseline on the Mini Mental State Exam (MMSE) Score at Weeks 13, 26, and 39|The MMSE is a brief 30-point questionnaire test that is used to assess cognition. It is commonly used to screen for dementia. In the time span of about 10 min, it samples various functions, including arithmetic, memory and orientation. Scores range from 0 to 30 (higher scores indicate less impairment) and participants with scores of 16 to 26 were eligible.|Baseline, Weeks 13, 26 and 39|All participants who were randomized to a treatment and received at least one infusion of study medication. n = number of evaluable participants at the corresponding timeframe.||Units on a scale||Standard Deviation|Mean
826972|NCT01193608|Other Pre-specified|Change From Baseline on the Clinical Dementia Rating (CDR) Sum of Boxes (CDR-SB) and Global CDR Rating at Weeks 26 and 39|The CDR scale is a clinician-rated dementia staging instrument that tracks the progression of cognitive impairment in the following 6 categories – memory, orientation, judgment and problem solving, involvement in community affairs, home and hobbies, and personal care based on the CDR interview. The CDR is based on discussions between the clinician with the participant and caregiver using a structured format. A global CDR score is established by clinical scoring rules with values of 0 (no dementia), 0.5 (questionable dementia), 1 (mild dementia), 2 (moderate dementia), and 3 (severe dementia). A more quantitative version of the CDR scale is obtained by summing up the ratings in each of the 6 categories to provide the (CDR-SB). The CDR-SB scale ranges from 0 to 18 where higher score indicates severe dementia.|Baseline, Weeks 26 and 39|All participants who were randomized to a treatment and received at least one infusion of study medication. n = number of evaluable participants at the corresponding timeframe.||Units on a scale||Standard Deviation|Mean
826973|NCT01193608|Other Pre-specified|Change From Baseline in Behavioral Symtoms as Measured by the Neuropsychiatric Inventory (NPI) at Weeks 13, 26 and 39|The NPI is an instrument used to assess changes of behavior that have appeared in a defined period of time in participants with Alzheimer's disease (AD) and other dementias. Twelve (12) behavioral areas are assessed in the NPI – delusions, apathy, hallucinations, disinhibition, agitation, irritability, depression, aberrant motor behavior, anxiety, nighttime behaviors, euphoria, appetite, and eating changes. The NPI score is based on frequency and severity of specific behaviors within these categories as reported by the caregiver. A separate caregiver distress score may also be included. The NPI ranges from 0 to 144 (higher scores indicate greater psychopathology).|Baseline, Weeks 13, 26 and 39|All participants who were randomized to a treatment and received at least one infusion of study medication. n = number of evaluable participants at the corresponding timeframe.||Units on a scale||Standard Deviation|Mean
826974|NCT01193608|Other Pre-specified|Change From Baseline in Disability Assessment in Dementia (DAD) Score at Weeks 13, 26 and 39|The DAD is a functional assessment based on an interview with the caregiver that takes approximately 20 min to administer and it is comprised of 40 items, 17 related to self-care and 23 items involving instrumental activities of daily living. The DAD is scored from 0 to 100 (higher scores indicate better functioning).|Baseline, Weeks 13, 26 and 39|All participants who were randomized to a treatment and received at least one infusion of study medication. n = number of evaluable participants at the corresponding timeframe.||Units on a scale||Standard Deviation|Mean
826975|NCT01193608|Other Pre-specified|Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog) Score at Weeks 13, 26 and 39|The ADAS-cog 70 Point is a structured scale (approximately 40 min to complete) that evaluates memory, orientation, attention, reasoning, language and constructional praxis. This study used the 11-item cognitive subscale of the ADAS-Cog with scores ranging from 0 to 70 points; higher scores indicated greater cognitive impairment.|Baseline, Weeks 13, 26 and 39|All participants who were randomized to a treatment and received at least one infusion of study medication. n = number of evaluable participants at the corresponding timeframe.||Units on a scale||Standard Deviation|Mean
826976|NCT01193608|Other Pre-specified|Number of Participants With Positive Anti-product Antibody Response to AAB-003 in Serum|Human serum anti-drug antibodies (ADA) samples were analyzed for the presence or absence of anti-AAB-003 antibodies by enzyme-linked immunosorbent assay (ELISA) method|Day 1 (predose), Week 13 (predose), Week 26 (predose) and Week 39 or Early Withdrawal|All participants who received an infusion of study medication. n = number of evaluable participants at the corresponding timeframe.||Participants|||Number
826977|NCT01193608|Primary|Number of Participants With Change From Baseline and Absolute Values in Electrocardiogram (ECG) Meeting Categorical Summarization Criteria|Criteria for ECG values of potential clinical concern are: interval between the start of the ECG P wave and the start of the QRS complex corresponding to the time between onset of atrial depolarization and onset of ventricular depolarization (PR): >= 300 milliseconds (msec), and >=25% increase when baseline >=200 msec/ >=50% increase when baseline less than or equal to (<=) 200 msec; time from ECG Q wave to the end of S wave corresponding to ventricular depolarization (QRS): >=200 msec, and >=25% increase when baseline >100 msec/ >=50% increase when baseline <=100 msec; QTc using Fridericia's formula (QTcF) interval: 450 to <480 msec, >=480 msec; QTcF change from baseline: 30 to <60 msec, and >=60 msec.|Baseline, Weeks 1,13,16,26,39 or Early Withdrawal|Safety Analysis Set included all participants who received an infusion of study medication (including partial infusions).||Participants|||Number
827183|NCT01202253|Secondary|Infecting Organisms by Species||Baseline up to Day 14 post-treatment|Full analysis set included all participants who met the defined eligibility criteria.||participants|||Number
826978|NCT01193608|Primary|Number of Participants With Vasogenic Edema of All Severity After Each Infusion Visit|VE of the brain, identified via MRI, was identified as an adverse event of special circumstance.|Day 1, Week 13, and Week 26|Safety Analysis Set included all participants who received an infusion of study medication, including partial infusions. n = number of evaluable participants at the corresponding timeframe.||Participants|||Number
826979|NCT01193608|Primary|Number of Participants With New Occurrence of Brain Magnetic Resonance Imaging (MRI) Finding|Brain MRIs were collected during the course of study to assess for any potential drug-related changes that might have constituted a safety concern for study participants. Findings suggestive of either vasogenic edema (VE) or intracranial hemorrhage represented adverse events of special circumstance and were to be reported immediately.|Baseline up to Week 32.|Safety Analysis Set included all participants who received an infusion of study medication (including partial infusions).||Participants|||Number
826980|NCT01193608|Primary|Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)|The C-SSRS assessed whether the participant experienced the following: completed suicide (1), suicide attempt (2) (response of “Yes” on “actual attempt”), preparatory acts toward imminent suicidal behavior (3)(“Yes” on “preparatory acts or behavior”), suicidal ideation (4) (“Yes” on “wish to be dead”, “non-specific active suicidal thoughts”, “active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7)(“Yes” on “Has participant engaged in non-suicidal self-injurious behavior”).|Baseline up to Week 39 or Early Withdrawal|Safety Analysis Set included all participants who received at least one infusion of study medication (including partial infusions).||Participants|||Number
826981|NCT01193608|Primary|Serum Decay Half-Life (t1/2) for AAB-003 at Week 26||Pre-dose, 1 hour (end of infusion), 1.5, 2, 4, 6, and 24 hours post start of infusion.|Evaluable participants in the PK analysis set (all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment).||Days||Standard Deviation|Mean
826982|NCT01193608|Primary|Serum Decay Half-Life (t1/2) for AAB-003 at Day 1||Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.|Evaluable participants in the PK analysis set (all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment).||Days||Standard Deviation|Mean
826983|NCT01193608|Primary|Volume of Distribution at Steady State (Vss) for AAB-003 in Serum at Week 26||Pre-dose, 1 hour (end of infusion), 1.5, 2, 4, 6, and 24 hours post start of infusion.|Evaluable participants in the PK analysis set (all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment).||mL/kg||Geometric Coefficient of Variation|Geometric Mean
826984|NCT01193608|Primary|Volume of Distribution at Steady State (Vss) for AAB-003 in Serum at Day 1||Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.|Evaluable participants in the PK analysis set (all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment).||mL/kg||Geometric Coefficient of Variation|Geometric Mean
826985|NCT01193608|Primary|Systemic Clearance (CL) for AAB-003 in Serum at Week 26||Pre-dose, 1 hour (end of infusion), 1.5, 2, 4, 6, and 24 hours post start of infusion.|Evaluable participants in the PK analysis set (all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment).||mL/hr/kg||Geometric Coefficient of Variation|Geometric Mean
826986|NCT01193608|Primary|Systemic Clearance (CL) for AAB-003 in Serum at Day 1||Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.|Evaluable participants in the PK analysis set (all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment).||milliliter/hour/kilogram (mL/hr/kg)||Geometric Coefficient of Variation|Geometric Mean
826987|NCT01193608|Primary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for AAB-003 in Serum at Week 26||Pre-dose, 1 hour (end of infusion), 1.5, 2, 4, 6, and 24 hours post start of infusion.|Evaluable participants in the PK analysis set (all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment).||mcg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
826988|NCT01193608|Primary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for AAB-003 in Serum at Day 1||Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.|Evaluable participants in the PK analysis set (all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment).||mcg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
826989|NCT01193608|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for AAB-003 in Serum at Day 1||Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.|Evaluable participants in the PK analysis set (all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment).||mcg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
826990|NCT01193608|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for AAB-003 in Serum at Day 1||Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.|PK Analysis Set consisted of all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment||mcg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
826991|NCT01193608|Primary|Time to Reach Maximum Observed Serum Concentration (Tmax) for AAB-003 at Week 26||Pre-dose, 1 hour (end of infusion), 1.5, 2, 4, 6, and 24 hours post start of infusion.|Evaluable participants in the PK analysis set (all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment).||Hours (hr)||Full Range|Median
826992|NCT01193608|Primary|Time to Reach Maximum Observed Serum Concentration (Tmax) for AAB-003 at Day 1||Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.|PK Analysis Set consisted of all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment.||Hours (hr)||Full Range|Median
827184|NCT01202253|Secondary|Number of Participants With Infection Sites as Per Ultrasound Scan and Computerized Tomography (CT) Scan||Baseline|Data was not analyzed as the study was retrospective and data for infection site as per ultrasound and CT scan was not available.|||||
826993|NCT01193608|Primary|Average Concentration (Cavg) for AAB-003 in Serum at Week 26||Pre-dose, 1 hour (end of infusion), 1.5, 2, 4, 6, and 24 hours post start of infusion.|Evaluable participants in the PK analysis set (all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment).||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
826994|NCT01193608|Primary|Average Concentration (Cavg) for AAB-003 in Serum at Day 1||Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.|Evaluable participants in the PK analysis set (all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment).||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
826995|NCT01193608|Primary|Maximum Observed Serum Concentration (Cmax) for AAB-003 at at Week 26||Pre-dose, 1 hour (end of infusion), 1.5, 2, 4, 6, and 24 hours post start of infusion.|Evaluable participants in the PK analysis set (all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment).||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
826996|NCT01193608|Primary|Maximum Observed Serum Concentration (Cmax) for AAB-003 at Day 1||Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.|Pharmacokinetic (PK) Analysis Set consisted of all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment.||microgram per milliliter (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
826997|NCT01193608|Primary|Number of Participants With Abnormal Neurological Examination Findings|The neurological examination was done to the extent needed to assess the participant for any potential changes in neurological status, as determined by the investigator. The minimum items assessed were level of consciousness, speech, cranial nerves, motor, sensory, coordination, gait, and tendon reflexes.|Screening, Day 1 (Baseline) and Weeks 1,6,13,19,26,32, and 39, and at Early Withdrawal|Safety analysis set consisted of all participants who received at least one infusion of study medication (including partial infusions). n = number of evaluable participants at the corresponding time point.||Participants|||Number
826998|NCT01193608|Primary|Number of Participants With Abnormal Physical Examination Findings||Baseline up to 39 Weeks and at Early Withdrawal|Safety analysis set consisted of all participants who received at least one infusion of study medication (including partial infusions). A full physical examination consisted of abdomen, genitourinary, cardiovascular systems, lungs, lymph nodes, mouth, musculoskeletal, general, skin, extremities, head, ears, eyes, nose, throat and thyroid.||Participants|||Number
826999|NCT01193608|Primary|Number of Participants With Vital Signs of Potential Clinical Concern|Criteria for potential clinical concern in vital signs included: supine/sitting pulse rate of less than (<) 40 or more than (>) 120 beats per minute (bpm), and standing pulse rate of <40 or >140 bpm; systolic blood pressure (SBP) of more than or equal to (>=)30 millimeters of mercury (mm Hg) change from baseline in same posture and <90 mm Hg; diastolic blood pressure (DBP) >=20 mm Hg change from baseline in same posture and <50 mm Hg. Only supine vital signs were planned for this study. Unplanned sitting vital signs were collected only in the 8/mg and placebo groups and also reported.|Baseline up to 39 Weeks and at Early Withdrawal|Safety analysis set consisted of all participants who received at least one infusion of study medication (including partial infusions).||Participants|||Number
827000|NCT01193608|Primary|Number of Participants With Laboratory Abnormalities||Baseline up to 39 Weeks and at Early Withdrawal|Safety analysis set consisted of all participants who received at least one infusion of study medication (including partial infusions). Laboratory test parameters included hematology, coagulation, liver function, renal function, electrolytes, clinical chemistry, and urinalysis (dipstick and microscopy).||Participants|||Number
827001|NCT01193608|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)||Baseline up to 39 Weeks and at Early Withdrawal|Safety analysis set consisted of all participants who received at least one infusion of study medication (including partial infusions). A TEAE was defined as an untoward medical occurrence reported by the participant or investigator following administration of at least one dose of AAB-003.||Participants|||Number
827002|NCT01193660|Secondary|Number of Participants With Serious Adverse Events as a Measure of Safety,Which Are Related to Umbilical Cord Blood, Erythropoietin, or Immunosuppressant|The number of patients with serious adverse events within each group; Serious adverse events were defined as any event that resulted in death, was life-threatening, required hospitalization or prolonged the hospital stay, or was otherwise serious in the judgment of the investigator.|6 months|||participants|||Number
827003|NCT01193660|Secondary|Changes in Hand Function|QUEST (Quality of Upper Extremity Skills Test) as a standardized measurement tool for assessing hand function consisting of sub-scales; dissociated movement, grasps, weight bearing, and protective extension. These are standardized to range from zero (or below zero in grasp section) to 100 and higher values mean better hand function. We reported QUEST differences between each assessment times.|Baseline - 1 month - 3 months - 6 months|Intention to treat||units on a scale||Standard Error|Mean
827004|NCT01193660|Secondary|Changes in Muscle Strength|Summation of MMT (manual muscle strength test score): summated scores of the manual muscle strength test (zero=0, trace=1, poor=2, fair=3, good=4, normal=5) for flexors, extensors, abductors, and adductors of bilateral shoulder and hip joints; flexors and extensors of bilateral elbow, wrist, and knee; dorsiflexors and plantar flexors of the ankles (range: 0 ~ 160) Higher score means better muscle strength. Categories of outcome table are summation of MMT scores measured at each assessment time point.|Baseline - 1 month - 3 months - 6 months|Intention to treat||units on a scale||Standard Error|Mean
827005|NCT01193660|Secondary|Changes in Functional Independence in Daily Activities|WeeFIM (Functional Independence Measure for Children) measures functional independence in daily activities. WeeFIM contains 18 items and each item is ranked from complete dependence (scored as 1) to complete independence (scored as 7). The range is from 18 to 126 and higher scores mean more independent performance in daily activities. Categories of outcome table are total WeeFIM scores measured at each assessment time point.|Baseline - 1 month - 3 months - 6 months|Intention to treat||units on a scale||Standard Error|Mean
827034|NCT01193920|Secondary|Number of Non-pregnant Subjects Reporting Solicited and Unsolicited Adverse Events|Number of non-pregnant subjects reporting solicited and unsolicited adverse events following 2 injections (1 month apart) of the trivalent GBS vaccine at a dose of 20/20/20 μg with aluminum at one month after second vaccination are reported.|Day 61|Safety set, solicited and unsolicited reactogenicity, non-pregnant subjects||participants|||Number
827006|NCT01193660|Primary|Changes in Standardized Gross Motor Function|GMFM (Gross Motor Function Measure) as a standardized measurement tool for assessing Gross Motor Function consisting of sub-scales; lying & rolling, sitting, crawling & kneeling, standing, walking, running & jumping (range: 0~100 , Higher value means better gross motor function). We reported changes of GMFM between each assessment time points. Categories of outcome table are baseline and values of just subtracting the latter raw scores from the former ones.|Baseline - 1 month - 3 months - 6 months|Intention to treat||units on a scale||Standard Error|Mean
827007|NCT01193660|Secondary|Changes in Functional Performance in Daily Activities|Pediatric Evaluation of Disability Inventory (PEDI) for assessing functional performance in daily activities in children (All values are adjusted and higher value means better functional performance, 0 - worst, 100 - best). We reported here 2 scales and 3 domains of each scale: a Functional Skill Scale (FSS) and a Caregiver Assistance Scale (CAS) which are divided respectively into 3 domains: self care, mobility, and social function. Categories of outcome table are each domain scores measured at each assessment time point.|Baseline -1 month - 3 months - 6 months|Intention to treat||units on a scale||Standard Error|Mean
827008|NCT01193660|Secondary|Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism|"18F-FDG PET imaging was performed twice prior to and then 2 weeks post-treatment. Ninety slices of each emission image were obtained, and all scans were reviewed by a nuclear physician. Spatial pre-processing and statistical analyses were performed using SPM8 implanted in Matlab to compare differences in regional brain glucose metabolism between groups and differences between pre- and post-therapy imaging data. We reported increased areas and decreased areas of glucose metabolism in three groups. We defined that 1 refers to INCREASED areas, -1, DECREASED areas and 0, just NO CHANGE."|Baseline - 2 weeks|Intention to treat||units on a scale|||Number
827009|NCT01193660|Secondary|Changes in Brain MRI|Changes on brain Diffusion Tensor Image (DTI); DTI provides quantitative information about the microscopic integrity of white matter. White matter normally possesses a high degree of diffusion anisotropy than gray matter. We can measure fractional anisotropy (FA) value in DTI imaging and it ranges from 0 to 1. Higher FA value of a certain region of interest means the area has more integrity of white matter.|Baseline - 6 months|||units on a scale||Standard Error|Mean
827010|NCT01193660|Secondary|Changes in Motor Neurodevelopmental Outcome|Korean version of Bayley Scale of Infant Development-II (K-BSID-II) Motor Scales (higher value means better motor function: 0 - worst, 111 - best). We reported changes of BSID-II Motor Scale raw score between each assessment time points. Categories of outcome data are values of subtracting the latter scores from the former ones.|Baseline - 1 month - 3 months - 6 months|Intention to treat||units on a scale||Standard Error|Mean
827011|NCT01193660|Secondary|Changes in Cognitive Neurodevelopmental Outcome|Korean version of Bayley Scale of Infant Development-II (K-BSID-II) Mental Scales (higher value means better mental function: 0 - worst, 178 - best). We reported changes of BSID-II Mental Scale raw score between each assessment time points. Categories of outcome data are values of subtracting the latter scores from the former ones.|Baseline -1 month - 3 months - 6 months|Intention to treat||units on a scale||Standard Error|Mean
827012|NCT01193660|Primary|Changes in Motor Performance|GMPM (Gross Motor Performance Measure) as a standardized measurement tool for assessing quality of movement regarding 3 properties of 5 ones; alignment, coordination, dissociated movement, stability, and weight shift (range: 0~100, Higher value means better motor quality). We reported changes of GMPM score between each assessment time points. Categories of outcome table are baseline and values of just subtracting the latter raw scores from the former ones.|Baseline -1 month - 3 months - 6 months|Intention to treat||units on a scale||Standard Error|Mean
827013|NCT01193686|Secondary|General Anger Level|5-item scale developed for this study. Assesses level of perceived experienced anger in the past month. Possible scores range from 5-35 with higher scores indicating greater levels of anger.|Post- Participation|This measure was only administered to Recipients of Peer Visits.||units on a scale||Full Range|Mean
827014|NCT01193686|Secondary|Patient Activation Measure|Measures participante self-efficacy, knowledge of and engagement in health care. Possible scores range from 13-52 with higher scores indicating greater efficacy/knowledge/engagement.|Post- Participation|This measure was only administered to Recipients of Peer Visitation.||units on a scale||Full Range|Mean
827015|NCT01193686|Secondary|Post-Traumatic Stress Disorder Checklist- Military Version (PCL-M)|Measures PTSD symptoms. Possible scores range from 19-95, with higher scores indicating greater symptom severity.|Upon study completion.|||units on a scale||Full Range|Mean
827016|NCT01193686|Secondary|Patient Health Questionnaire-9 (Depression Screen)|9-item depression screen with possible response options ranging from 9-36, with higher numbers indicating greater depression symptom severity.|Upon completion of visits.|||units on a scale||Full Range|Mean
827017|NCT01193686|Primary|Post Traumatic Growth Inventory|Administered only to Peer Visitors, possible range 0-105, with higher scores indicating greater post-traumatic growth. Post-traumatic growth includes emotional changes such as noticing a stronger sense of self, deepened relationships, increased sense of gratitude or appreciation for life, increased spirituality.|Upon completion of study requirements (i.e., visits)|This measure was only administered to Veteran Peer Visitors.||units on a scale||Full Range|Mean
827018|NCT01193868|Secondary|Progression-free Survival|Time from initiation of study drug until death, progression of tumor, or for worsening of tumor that did not meet RECIST 1.1 criteria but that did require discontinuation of therapy, assessed up to 5 years|Baseline up to 5 years|Study terminated early. Analysis not performed due to small numbers.|||||
827019|NCT01193868|Secondary|Correlation of Tumor Shrinkage/Response With Biomarker Expression|Correlate percent change in tumor size at 6 weeks (or at time off study, if therapy is stopped earlier due to tumor progression) with tumor Immunohistochemistry (IHC) scores for Notch pathway and stem cell markers; Tumor % shrinkage with RO4929097 will correlate with pre-therapy tumor expression of Notch pathway members, with expression of stem cell markers, and with changes in these over the first cycle of therapy.|6 weeks|Study terminated early. Analysis not performed due to small numbers.|||||
827035|NCT01193920|Secondary|Antibody GMC in Non-pregnant Subjects at One Year After the First Vaccination|Antibody GMC per serotype in non-pregnant subjects after receiving two doses of the study vaccine administered one month apart, at one year after first vaccination.|Day 361, one year after the first vaccination|FAS persistence, non-pregnant subjects||concentration (μg/mL)||95% Confidence Interval|Geometric Mean
827020|NCT01193868|Secondary|Proportion of Tumors Expressing the Expression of Tumor Notch Markers and Stem Cell Markers of Interest in Participants With vs Without Tumor Progression|Tumor Immunohistochemistry (IHC) scores for Notch pathway and stem cell markers used in comparison to tumor progression; and progression evaluated in using international criteria proposed by revised RECIST guideline (version 1.1). Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the RECIST criteria. Wilcoxon rank sum tests will be used. Compared using Fisher Exact Tests.|Up to 3 months|Study terminated early with low accrual leading to insufficient data for analysis.|||||
827021|NCT01193868|Secondary|Proportion of Tumors Expressing the Expression of Tumor Notch Markers and Stem Cell Markers of Interest in Participants With vs Without Response by RECIST Criteria|Wilcoxon rank sum tests will be used.|Up to day 3|Study terminated early. Analysis not performed due to small numbers.|||||
827022|NCT01193868|Secondary|Proportion of Tumors Expressing the Expression of Tumor Notch Markers and Stem Cell Markers of Interest in Participants With vs Without Epidermal Growth Factor Receptor (EGFR) Activating Mutations|Wilcoxon rank sum tests will be used. Compared using Fisher Exact Tests. For participants having biopsies both before and after the agent, paired comparisons of post-therapy to pre-therapy results for the Notch IHC scores will be used. Researchers will assess changes from pre-therapy to post-therapy using a Wilcoxon Signed Rank Test (Sum Test). Spearman coefficients will be used to correlate tumor expression of Notch pathway markers with expression of stem cell markers.|Up to day 3|Study terminated early with low accrual leading to insufficient data for analysis.|||||
827023|NCT01193868|Secondary|Proportion of Tumors Expressing the Expression of Tumor Notch Markers and Stem Cell Markers of Interest in Participants With Versus Without a Particular Host Genotype Polymorphism|Wilcoxon rank sum tests will be used. For participants having biopsies both before and after the agent, paired comparisons of post-therapy to pre-therapy results for the Notch IHC scores will be used. Researchers will assess changes from pre-therapy to post-therapy using a Wilcoxon Signed Rank Test (Wilcoxon rank sum tests).|Up to day 3|Study terminated early with low accrual leading to insufficient data for analysis.|||||
827024|NCT01193868|Secondary|Proportion of Tumors Expressing the Expression of Tumor Notch Markers and Stem Cell Markers of Interest in This Population vs Tumor Bank Population|For participants having biopsies both before and after the agent, paired comparisons of post-therapy to pre-therapy results for the Notch IHC scores will be used. Researchers will assess changes from pre-therapy to post-therapy using a Wilcoxon Signed Rank Test (Wilcoxon rank sum tests). Spearman coefficients will be used to correlate tumor expression of Notch pathway markers with expression of stem cell markers.|Up to day 3|Study terminated early with low accrual leading to insufficient data for analysis.|||||
827025|NCT01193868|Primary|Percentage of Tumor Shrinkage as a Continuous Variable|Response is reported as a continuous variable, as % change in tumor size from baseline. Pearson and Spearman correlation coefficients will be used. Reported with 95% two-sided confidence intervals.|6 weeks|Study terminated early with low accrual leading to insufficient data for analysis.|||||
827026|NCT01193868|Primary|Response Rate by Response Evaluation Criteria in Solid Tumors (RECIST)|Percentage of participants with response per RECIST version 1.1: Complete Response (CR):Disappearance all target lesions. Any pathological lymph nodes with reduction in short axis to <10 mm. Partial Response (PR): At least 30% decrease in sum of diameters of target lesions, reference baseline sum diameters. Progressive Disease (PD): At least 20% increase in sum of diameters of target lesions, reference smallest sum on study (includes baseline sum if that is smallest on study). In addition to relative increase of 20%, sum must demonstrate an absolute increase of at least 5 mm. (Note: appearance of 1 or more new lesions also considered progressions). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum diameters while on study. Best response recorded from treatment start until disease progression/recurrence (reference for progressive disease the smallest measurements recorded since treatment started).|Response evaluation every 6 weeks (in addition to baseline scan, confirmatory scans approximately 6-7 (not less than 4) weeks following initial documentation of objective response). Expected follow up to 5 years, actual study period 9/2010 to 4/2014.|Only those participants who have measurable disease present at baseline and received at least one dose of study medication considered evaluable for response with their response classified according to the RECIST definitions stated. Participants who exhibit objective disease progression prior to the end of cycle 1 also considered evaluable.||percentage of participants|||Number
827027|NCT01193907|Primary|Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titer||At 28 days after vaccination|||percentage of subjects||95% Confidence Interval|Number
827028|NCT01193907|Primary|Anti-Vi ELISA (Enzyme Linked Immunosorbent Assay) Geometric Mean Concentration (GMC)||At 28 days after vaccination|||GMC||95% Confidence Interval|Mean
827029|NCT01193907|Primary|Number of Subjects Reporting Adverse Events||During the 28-day period after vaccination|||participants|||Number
827030|NCT01193907|Primary|Number of Subjects Reporting Any Post Immunization Reactions|Solicited reactions collected during the 7-day period after vaccination are pain, erythema, induration, chills, malaise, myalgia, headache, arthralgia and fatigue|During the 7-day period after vaccination|||participants|||Number
827031|NCT01193920|Secondary|Number of Infants Reporting Serious Adverse Events|Number of infants born from women who received either one of three different doses of the study vaccine or placebo who reported serious adverse events|one year after birth|||Number of subjects|||Number
827032|NCT01193920|Secondary|Antibody GMC Per Serotype at Different Time Points in Infants|Antibody GMC per serotype on the day of birth, at 6 weeks and 3 months of age in infants born from women who received either one of three different doses of the study vaccine or placebo.|Day 4, day 43 and day 91 after birth|Per Protocol Set, infants, i.e. all subjects who provided evaluable serum samples at birth, study day 43, study day 91 and within the required time frames||concentration (μg/mL)||95% Confidence Interval|Geometric Mean
827033|NCT01193920|Secondary|Number of Maternal Subjects Reporting Solicited and Unsolicited Adverse Events|Number of maternal subjects reporting solicited and unsolicited adverse events following the administration of either one of three different doses of the study vaccine or placebo.|From day 1 to one year after delivery|Safety set, solicited and unsolicited reactogenicity, maternal subjects||participants|||Number
835432|NCT01287416|Secondary|Lifetime Suicide Attempt at Baseline|Number of people who endorsed having made a suicide attempt in their lifetime as measured at baseline|July 19-20, 2010|||participants|||Number
827036|NCT01193920|Secondary|The Percentage of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Year After the First Vaccination.|The percentage of non-pregnant subjects with antibody concentrations above a defined threshold per serotype after the administration of two vaccine doses one month apart. Antibody concentrations which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 mcg/mL.|Day 361, one year after the first vaccination|FAS persistence, non-pregnant subjects, i.e. all enrolled subjects who provided at least one evaluable serum sample result at day 1 (prior to vaccination) and day 361.||percentage of subjects||95% Confidence Interval|Number
827037|NCT01193920|Secondary|Antibody GMC Per Serotype in Maternal Subjects at One Month After Vaccination|Antibody GMC per serotype in maternal subjects at one month after the administration of one of three different doses of the study vaccine or placebo.|day 31|FAS, secondary, maternal subjects, day 31||concentration (μg/mL)||95% Confidence Interval|Geometric Mean
827038|NCT01193920|Primary|Antibody GMC in Maternal Subjects at Day of Delivery|Antibody GMC per serotype in maternal subjects at day of delivery following one administration of one of three different doses of the study vaccine or placebo are reported.|Day of delivery|FAS primary, maternal subjects||Concentration (μg/mL)||95% Confidence Interval|Geometric Mean
827039|NCT01193920|Primary|The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery.|The percentages of maternal subjects with antibody concentrations above a defined threshold per serotype following the administration of one of three different doses of the study vaccine or placebo.Antibody concentrations which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 μg/mL.|Day of delivery|FAS primary, maternal subjects, i.e. all enrolled subjects who provided at least one evaluable serum sample result at day 1 (prior to vaccination) and at delivery||percentage of subjects||95% Confidence Interval|Number
827040|NCT01193920|Secondary|The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination.|The percentages of maternal subjects with antibody concentrations above a defined threshold per serotype at one month after the administration of one of three different doses of the study vaccine or placebo. Antibody concentrations which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 μg/mL.|Day 31, one month after vaccination|FAS, secondary, maternal subjects, day 31, i.e. all enrolled subjects who provided at least one evaluable serum sample result at day 1 (prior to vaccination) and at day 31||percentage of subjects||95% Confidence Interval|Number
827041|NCT01193920|Primary|Antibody Geometric Mean Concentrations (GMC) in Non-pregnant Women at One Month After the Second Vaccination.|Antibody GMC per serotype in non-pregnant women after receiving two doses of the study vaccine administered one month apart .|Day 61, one month after the second vaccination|FAS - primary, non-pregnant subjects||concentrations (μg/mL)||95% Confidence Interval|Geometric Mean
827042|NCT01193920|Primary|The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination.|The percentages of non-pregnant subjects with antibody concentrations above a defined threshold per serotype after the administration of two vaccine doses administered one month apart. Defined thresholds for antibody concentrations, which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 μg/mL.|Day 61, one month after the second vaccination|Full Analysis Set (FAS) – primary, non-pregnant subjects, i.e. all enrolled subjects who provided at least one evaluable serum sample result at Day 1 (prior to vaccination) and Day 61||percentage of subjects||95% Confidence Interval|Number
827043|NCT01194089|Secondary|Numeric Pain Score|Upon arrival in the PACU and at least every 30 minutes thereafter while in the PACU, the subject was asked to report pain using a numerical pain score for current pain at rest from 0 (representing no pain) to 10 (representing the worst imaginable pain).|on admission, 30 minutes, 60 minutes, at discharge|Not all participants completed the pain scale at every time point. The participants analyzed per arm (nicotine, normal) at each time point were: on admission (40, 45); 30 minutes (40, 47); 60 minutes (34, 40); at discharge (39, 44),||units on a scale||Inter-Quartile Range|Median
827044|NCT01194089|Secondary|Number of Participants Who Needed to Use Antiemetic Medication in the PACU|Rescue antiemetic therapy was 0.625 mg droperidol. Recalcitrant postoperative pain, nausea and vomiting (PONV) was treated per discretion of the supervising anesthesiologist.|24 hours postoperatively.|||participants|||Number
827045|NCT01194089|Primary|Postoperative Opioid Use During the Postanesthesia Care Unit (PACU) Stay, and the First 24 Hours Postoperatively|Opioid use was calculated in intravenous morphine equivalents (iv MEQ) according to the Mayo Clinic Pharmacy opioid conversion calculator based on the recommendations from the American Pain Society. Specifically, the following conversion was used: 10 mg in MEQ=100mcg iv fentanyl=1.5 mg iv hydromorphone=20mg oral oxycodone=30mg oral hydrocodone.|During PACU stay (approximately 94 minutes after operation), 24 hours after operation|||mg||Inter-Quartile Range|Median
827046|NCT01194154|Secondary|Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability or incapacity; and congenital anomaly. Percentage of participants with AEs included participants affected with both SAEs and non-SAEs.|24 months|The Safety Analysis Set (SAF) included all participants who received at least one dose of study medication. Analysis for SAF was performed according to the study medication actually received (as treated population). Number of participants analyzed=participants evaluable for this measure.||percentage of participants|||Number
827047|NCT01194154|Secondary|Change From Baseline in Serum Cystatin C Concentration at Month 24|Cystatin C is a protein which is mainly used as a biomarker of kidney function. If kidney function and GFR decline, the blood levels of cystatin C rise.|Baseline, Month 24|FAS included all randomized participants who received at least one dose of the study medication and provided any successive eGFR measurement. Here, n=number of participants evaluable for each category.||mg/L||Standard Deviation|Mean
827075|NCT01200602|Primary|Proportion of Patients Who Maintain Weight or Experience Weight Gain|A patient will be defined as “success” if he/she maintains or gains weight at the end if Initial Treatment compared with baseline of study entry.|4 weeks|Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.|||||
827048|NCT01194154|Secondary|Change From Baseline in Urinary Albumin Creatinine Ratio (UACR) at Month 24|UACR is defined as the ratio: milligram of albumin per gram of creatinine. The presence of albumin in the urine (macroalbuminuria) is a marker of kidney disease. Albumin and creatinine concentrations were obtained from spot urine samples.|Baseline, Month 24|FAS included all randomized participants who received at least one dose of the study medication and provided any successive eGFR measurement. Number of Participants Analyzed (N) = number of participants evaluable and available with valid data for this outcome measure. Here, n=number of participants evaluable for each category.||mg/g||Standard Deviation|Mean
827049|NCT01194154|Secondary|Change From Baseline in Serum Creatinine Concentration at Month 24|Serum creatinine is an indicator of kidney function. Creatinine is a substance formed from the metabolism of creatine, commonly found in blood, urine, and muscle tissue. It is removed from the blood by the kidneys and excreted in urine. Normal adult blood levels of creatinine=45 to 90 micromoles per liter (mcmol/L) for females, 60 to 110 mcmol/L for males, however normal values are age-dependent.|Baseline, Month 24|FAS included all randomized participants who received at least one dose of the study medication and provided any successive eGFR measurement. Here, n=number of participants evaluable for each category.||mcmol/L||Standard Deviation|Mean
827050|NCT01194154|Secondary|Change From Baseline in Calculated Creatinine Clearance (Cockcroft-Gault Equation) at Month 24|Creatinine clearance was calculated according to the Cockcroft and Gault Formula. It measures rate creatinine (substance formed from metabolism of creatine) is cleared from blood by kidneys. Normal adult creatinine clearance is greater than or equal to (>=) 90 mL/min. Change from baseline=CC at Week X minus CC at baseline where higher scores represented improved renal function.|Baseline, Month 24|FAS included all randomized participants who received at least one dose of the study medication and provided any successive eGFR measurement. Here, n=number of participants evaluable for each category.||mL/min||Standard Deviation|Mean
827051|NCT01194154|Secondary|Yearly Reduction Rate of Estimated Glomerular Filtration Rate (eGFR) Calculated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)|The eGFR value calculated using the CKD-EPI equation. The formula used is based on age, sex, ethnicity, and serum creatinine and eGFR values are calculated as follows: GFR in mL/min per 1.73 m^2 = 141 x min (SerumCr/k; 1)^a x max(SerumCr/k; 1)^(-1.209) x 0.993^age x F x B, where k=0.7 for female (else=0.9); a=-0.329 for female (else=-0.411), F=1.018 for female (else=1), B=1.159 for black (else=1), min/max=minimum/maximum of listed values. The Yearly Reduction Rate (mL/min/1.73m^2 / Year) is defined as –365.25 x Beta, where Beta is the slope parameter derived for each participant separately by simple linear regression of the change from baseline in participant's eGFR measurements (from Baseline to Visit 24) on the actual day of measurement.|24 months|FAS included all randomized participants who received at least one dose of the study medication and provided any successive eGFR measurement.||mL/min/1.73m^2/year||95% Confidence Interval|Least Squares Mean
827052|NCT01194154|Primary|Yearly Reduction Rate of Estimated Glomerular Filtration Rate (eGFR) Calculated by Modification of Diet in Renal Disease With 4 Variables (MDRD-4)|The yearly reduction in eGFR was calculated using the MDRD-4 formula. This formula is based on age, sex, and serum creatinine and eGFR values are calculated as follows: GFR in milliliter per minute (mL/min) per 1.73 meter square (m^2) = 175 x Serum Cr^-1.154 x age^-0.203 x 0.742 (if female). The yearly reduction rate (mL/min/1.73m^2 / Year) is defined as –365.25 multiplied by Beta, where Beta is the slope parameter derived for each participants separately by simple linear regression of the change from baseline in participant's eGFR measurements (from Baseline to Visit 24) on the actual day of measurement.|24 months|FAS included all randomized participants who received at least one dose of the study medication and provided any successive eGFR measurement.||mL/min/1.73m^2/year||95% Confidence Interval|Least Squares Mean
827053|NCT01200433|Secondary|Number of Apneic Episodes.|The number of antihypertensive interventions during Deep Brain Stimulation (DBS) surgery.|during DBS surgery|||number of episodes||Inter-Quartile Range|Median
827054|NCT01200433|Secondary|Number of Hypertensive Episodes|The number of hypertensive episodes during Deep Brain Stimulation (DBS) surgery.|During DBS surgery|||number of episodes||Standard Deviation|Mean
827055|NCT01200433|Secondary|Cerebral Perfusion Pressure||at the first peak during DBS surgery|||mmHg||Inter-Quartile Range|Median
827056|NCT01200433|Secondary|Pulsatility Index|Pulsatility index is a measure of the variability of blood velocity in a vessel, and was calculated as the difference between the peak systolic and minimum diastolic velocities divided by the mean velocity during the cardiac cycle.|at the first peak during DBS surgery|||units on a scale||Inter-Quartile Range|Median
827057|NCT01200433|Secondary|Alertness/Sedation|Modified observer's assessment of alertness /sedation (OAA/S) scale which ranges from 0 to 5 (0 = does not respond to noxious stimuli and 5 = responds to name spoken in normal tone)|at the first peak during DBS surgery|||units on a scale||Inter-Quartile Range|Median
827058|NCT01200433|Secondary|Cerebral Blood Flow|The investigator will test the hypothesis that dexmedetomidine is non-inferior to propofol for cerebral blood flow as measured by transcranial Doppler and brain oxygenation as measured by near-infrared spectroscopy.|after procedure, in post anesthesia care unit (PACU)|The cerebral flow at PACU was not planned as a primary outcome. The primary outcome was cerebral flow at the first peak of study drug. The data was collect for information purpose only. No test was done for cerebral blood flow at PACU.||cm/sec||Standard Deviation|Mean
827059|NCT01200433|Primary|Brain Oxygen|Brain oxygenation values were estimated by near-infrared spectroscopy and brain oxygenation was averaged across the first and second study drug infusion periods.|during first (10-20 minutes) and second (throughout the procedure) study drug infusion periods|||% oxygenation||Inter-Quartile Range|Median
827060|NCT01200433|Primary|Cerebral Blood Flow|Cerebral blood flow was the average of right and left carotid velocities recorded by transcranial Doppler.|For patients randomized to dexmedetomidine: at the first peak of study drug (i.e., at peak dose of study drug during first infusion period); for patients randomized to propofol: when infusion of propofol stopped.|||cm/sec||Inter-Quartile Range|Median
827076|NCT01201486|Primary|Sensitivity of Color Doppler Examination to Detect Major Heart Defects During the Second Trimester of Pregnancy|The number of *fetuses with* heart defects detected by color Doppler in the second trimester was compared to the number of *fetuses with* major heart defects detected at birth.|2nd trimester|||fetuses|||Number
827077|NCT01201629|Secondary|Discharge Disposition|Patient discharged home or to sub-acute facility|after 4 weeks of intervention|||Participants|||Count of Participants
827061|NCT01200498|Primary|Participants With an Objective Response|Objective response defined as Complete, Partial response, and Clinical Improvement based on International Working Group (IWG) Criteria: Complete remission (CR): Absence transfusion & growth factor support AND Complete resolution disease-related symptoms/signs; Peripheral blood count remission; Normal leukocyte differential; Bone marrow histological remission. Partial remission (PR): All CR except bone marrow histological remission. Clinical improvement (CI): No CR/PR, disease progression with one: ≥2 g/dL increase hemoglobin level or transfusion independent; Either ≥50% reduction in palpable splenomegaly of spleen ≥10 cm baseline or spleen palpable at >5 cm baseline becomes not palpable; ≥100% increase in platelet count & absolute platelet count ≥50,000 x 10^9/L; or ≥100% increase in absolute neutrophil count (ANC) & ANC ≥0.5 x 10^9/L. Progressive disease: Progressive splenomegaly or Leukemic transformation confirmed by bone marrow blast of ≥20%; or Increase peripheral blood blast|Baseline to 3 Cycles (84 days)|||Participants|||Number
827062|NCT01200511|Secondary|Patient Reported Outcomes at Month 6|The Visual Task Difficulty Assessment (VISTAS) questionnaire was completed by the subject to assess difficulty in completing everyday tasks that depend on good vision. Distance specific tasks were rated (without / with corrective aids) using a 1 to 5 point scale, where 1 = no difficulty; 2 = minor difficulty; 3 = moderate difficulty; 4 = major difficulty; 5 = cannot accomplish. Individual scores for each task were averaged to obtain the overall score for each vision type/function. Near vision was defined as less than 50 cm; intermediate vision as 50 cm to 1 m; extended intermediate vision as 90 cm to 4 m; and distant vision as more than 4 m.|Month 6 from second eye implantation|This analysis population includes all subjects receiving IOL implantation in both eyes with data at visit. A subject may have responded with and without.||units on a scale||Standard Deviation|Mean
827063|NCT01200511|Primary|Proportion of Subjects That Achieved Spherical Equivalent Within ± 0.5D, ± 0.75D, and ± 1.0D at Month 6|Manifest refraction was performed under well-lit conditions using an ETDRS chart. The subject was manually refracted to his/her best correction by an outcomes assessor using a phoropter or trial lenses. Manifest refraction was performed for each eye. Proportion of subjects that achieved spherical equivalent within ± 0.5D/ ± 0.75D/ ± 1.0D at Month 6 is reported as percentage of subjects.|Month 6 from second eye implantation|This analysis population includes all subjects receiving IOL implantation in both eyes with data at visit.||percentage of participants|||Number
827064|NCT01200511|Primary|Best Corrected Visual Acuity (BCVA) Across a Range of Distances at Month 6|VA was tested binocularly with correction in place if needed across a range of distances under well-lit conditions using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.|Month 6 from second eye implantation|This analysis population includes all subjects receiving IOL implantation in both eyes with data at visit.||logMAR||Standard Deviation|Mean
827065|NCT01200511|Primary|Uncorrected Visual Acuity Across a Range of Distances at Month 6|Visual acuity (VA) was tested binocularly (both eyes together) unaided across a range of distances under well-lit conditions using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.|Month 6 from second eye implantation|This analysis population includes all subjects receiving IOL implantation in both eyes with data at visit.||logMAR||Standard Deviation|Mean
827066|NCT01200524|Secondary|Change From Baseline to Day 29 in Neuropathic Pain Symptom Inventory Scal (NPSI) Total Score.|LOCF- Last Observation Carried Forward. At baseline and at end of treatment the participants filled in their Neuropathic Pain Symptom Inventory Scal (NPSI) pain symptom descriptors, recall period 24 hours. Each descriptor was rated on a NUmerical Rating Scale 0-10; 0=No (symptom), 10=Worst (symptom) imaginable. The NPSI Total Score was calculated as the sum of 10 of the NPSI descriptors. Higher total score is considered worse outcome.|Baseline (Day 1) to Day 29 (Visit 7)|mITT analysis set including only those that had adequate NPSI data at baseline and Day 29||Scores on a scale||Standard Deviation|Mean
827067|NCT01200524|Secondary|Number of Participants With at Least 50% Decrease From Baseline in Numerical RatingScale (NRS) Average Pain Score at Day 28.|"Last Observation Carried Forward (LOCF). Numerical Rating Scale (NRS) Average Pain score reduction=(change from baseline at Day 28/baseline)*100.
Responder= NRS Average Pain score reduction ≥50% (yes/no)"|Baseline (mean of Day -5 to Day -1) to Day 28|mITT analysis set||Participants|||Number
827068|NCT01200524|Secondary|Number of Participants With at Least 30% Decrease From Baseline in Numerical Rating Scale (NRS) Average Pain Score at Day 28.|LOCF- Last Observation Carried Forward. Numerical Rating Scale (NRS) Average Pain score reduction= (change from baseline at Day 28/baseline)*100. Responder=NRS Average Pain score reduction ≥30% (yes/no)|Baseline (mean of Day -5 to Day -1) to Day 28|mITT analysis set||Participants|||Number
827069|NCT01200524|Secondary|Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Worst Pain Score|Last Observation Carried Forward (LOCF). Twice daily, the participants rated their Worst Pain intensity during the past 12 hours on an Numerical Rating Scale (NRS) 0-10; 0=No pain, 10=Worst pain imaginable.|Baseline (mean of Day -5 to Day -1) to the mean of Day 24 to Day 28|mITT analysis set including only those that had adequate NRS data at baseline and Days 24-28||Scores on a scale||Standard Deviation|Mean
827070|NCT01200524|Primary|Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Average Pain Score.|Last Observation Carried Forward (LOCF). Twice daily, the participants rated their Average Pain intensity during the past 12 hours on an Numerical Rating Scale (NRS) scale 0-10. 0= No pain, 10= Worst pain imaginable.|Baseline (mean of Day -5 to Day -1) to the mean of Day 24 to Day 28|mITT analysis set including only those that had adequate NRS data at baseline and Days 24-28||Scores on a scale||Standard Deviation|Mean
827071|NCT01200602|Secondary|Toxicity Profile|Number of patients with grade 3+ non-hematologic adverse events using Common Toxicity Criteria for Adverse Effects (CTCAE) v.4.0|4 weeks|Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.|||||
827072|NCT01200602|Secondary|Weight Maintenance Over Time||4 weeks|Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.|||||
827073|NCT01200602|Secondary|Caloric Intake||4 weeks|Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.|||||
827074|NCT01200602|Secondary|BMI Trends||4 weeks|Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.|||||
827078|NCT01201629|Secondary|Action Research Arm Test (ARAT) Change Scores|The Action Research Arm Test (ARAT) is a standardized ordinal scale that measures upper extremity (arm and hand) function. This test assesses the ability to lift various sized objects to a height of 14.75 inches, move cylindrical shaped objects a distance of 14.75 inches, use pinch grasp to lift varying sized objects (such as a ball bearing, and a marble) between the thumb and the 3rd finger, and perform 3 gross upper extremity movements. Each upper extremity is evaluated individually. Score 0=no arm-hand movement and 57=normal|baseline to after 4-weeks of therapy|||units on a scale||Standard Deviation|Mean
827079|NCT01201629|Primary|Total Functional Independence Measure (TFIM) Change Scores|"The Functional Independence Measure (FIM™) will measure the degree of disability. The FIM scale is a reliable and valid functional assessment measure widely used in rehabilitation settings. The FIM has 18 items and each item is scored on an ordinal scale ranging from 1 to 7. A FIM™ item score of seven is categorized as complete independence, while a score of one is total assist (patient performs less than 25% of task). The total FIM score (TFIM) quantifies level of independence and ranges from 18 (lowest) to 126 (highest) level of independence."|from baseline to 4-weeks of therapy|||units on a scale||Standard Deviation|Mean
827080|NCT01201759|Secondary|Change in Fasting Values for Vascular Inflammation IL-6 at Visits 2-3 or 4-5|"The pro-atherogenic inflammatory mediators are assessed by the change in fasting values of Interleukin-6 in plasma concentration Pre and Post intervention at -30 min ( fasting).
For fasting values treatments (placebo and salsalate) and visits (pre and post) were defined as within subject’s factors."|Study visit at min -30 (fasting)|All enrolled participants who completed the study.||mg/dL||Standard Deviation|Mean
827081|NCT01201759|Secondary|Change in Area Under the Curve (AUC) for Lipemia (Free Fatty Acids ) at Visits 2-3 or 4-5 Depending on Order of Treatment Assignment.|"The postprandial lipemia is assessed by the change in the AUC for plasma Free fatty acids (FFA)sampled before and after intervention at time points of 0min immediately post feeding to 480 min.
For peak FFA area under the curve (AUC), treatments (placebo and salsalate) and visits (pre and post treatment) were defined as within-subject’s factors."|Each visit sampled at 0 (immediately post-feeding), and 30,60,90,120,240,360,480 min post-feeding..|All enrolled participants who completed the study.||mg*min/dL||Standard Deviation|Mean
827082|NCT01201759|Secondary|Change in Area Under the Curve (AUC) for Glycemia (Glucose) at Visits 2-3 or 4-5 Depending on Order of Treatment Assignment.|"The postprandial glycemia is assessed by the change in the AUC for plasma glucose sampled before and after intervention at time points of 0 (immediately post-feeding) to 480 min.
For peak Glucose, and Glucose area under the curve (AUC), treatments (placebo and salsalate) and visits (pre and post treatment) were defined as within-subject’s factors."|Blood samples for each visit were sampled at 0 (immediately post-feeding), and 30,60,90,120,240,360,480 min post-feeding..|All participants who completed treatment.||mg*min/dL||Standard Deviation|Mean
827083|NCT01201759|Primary|Change in Area Under the Curve (AUC) for Lipemia (Triglycerides) at Visits 2-3 or 4-5 Depending on Order of Treatment Assignment.|"The postprandial lipemia is assessed by the change in the AUC for plasma triglycerides sampled before and after intervention at time points 0 (immediately post-feeding)to 480 min.
For peak TG, and TG area under the curve (AUC), treatments (placebo and salsalate) and visits (pre and post treatment) were defined as within-subject’s factors."|Each visit samples at 0 (immediately post-feeding), and 30,60,90,120,240,360,480 min post-feeding..|All enrolled participants who completed the study.||mg*min/dL||Standard Deviation|Mean
827084|NCT01201772|Primary|PRI Levels at 4 Hours||4 hours after treatment|A total of 65 patients were randomized. One patient assigned to the 10mg prasugrel group was withdrawn after randomization due to anemia identified after baseline blood sampling. Finally, 64 patients [10 mg (n=22), 30 mg (n=21) and 60 mg (n=21)] completed all time periods of the study.||percentage of platelet reactivity||Standard Error|Mean
827085|NCT01201785|Primary|Collagen Induced Aggregation|Collagen induced aggregation using light transmittance aggregometry|after 1 -week of treatment|A 20% SD for the difference between collagen-induced platelet aggregation in patients on aspirin 81 mg od versus 81 mg bid was assumed, and based on a power of 80% and a significance level of 0.05. Based on these values, we determined that a sample population of 20 patients would be needed.||percentage of platelet aggregation||Standard Deviation|Mean
827086|NCT01201798|Secondary|Change From Baseline (Day 0) in Slit-Lamp Total Sign Score at All Visits|The following signs were each graded on a 0 – 3 scale (0 = absent; 1 = mild; 2 = moderate; 3 = severe): posterior synechia, hypopyon, limbal injection, and keratic precipitates. Peripheral synechia was graded by the combined number of clock hours affected (0 = absent; 1 = < 3 hrs; 2 = 3-6 hours; 3 = > 6 hours). The total sign score was calculated as the sum of the 5 individual sign scores, the anterior chamber cell grade and the anterior chamber flare grade. The minimum/best total sign score was 0, and the maximum/worst total sign score was 23.|Baseline (Day 0), Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42|Per Protocol: All randomized patients who received at least one dose of the allocated study medication and had no major protocol deviations, including violation of entry criteria, poor compliance, and use of prohibited medications. Last observation carried forward (LOCF) was performed for missing data.||Units on a scale||Standard Deviation|Mean
827087|NCT01201798|Secondary|Change From Baseline (Day 0) in Visual Analog Scale (VAS) Total Symptom Score at All Time Points|The following symptoms were each graded by the subject according to a 0-100 visual analog scale (VAS) using a mark on a 100 mm line (0 = absent, 100 = maximal): eye pain, photophobia, blurred vision, and lacrimation. The total symptom score was calculated as the sum of the 4 individual symptom scores.|Baseline (Day 0), Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42|Per Protocol: All randomized patients who received at least one dose of the allocated study medication and had no major protocol deviations, including violation of entry criteria, poor compliance, and use of prohibited medications. Last observation carried forward (LOCF) was performed for missing data.||Units on a scale||Standard Deviation|Mean
827088|NCT01201798|Secondary|Proportion of Subjects Who Discontinued Due to Lack of Efficacy|Lack of efficacy was defined as those subjects who discontinued study participation either due to treatment failure or an adverse event with a preferred term of iridocyclitis, iritis, uveitis, or vitritis. Proportion is reported as percentage of subjects.|Time to Event|Per Protocol: All randomized patients who received at least one dose of the allocated study medication and had no major protocol deviations, including violation of entry criteria, poor compliance, and use of prohibited medications.||Percentage of subjects|||Number
835433|NCT01287416|Secondary|Lifetime Suicidal Ideation at Baseline|Number of people who endorsed having thought about suicide in their lifetime as measured at baseline|July 19-20, 2010|||participants|||Number
827089|NCT01201798|Secondary|Proportion of Subjects With Anterior Chamber Cell Grade ≤1|As assessed by the investigator during slit lamp examination. Anterior chamber cell grade was graded on a 5-point scale, with 0 = no cells; 1 = 1 to 10 cells; 2 = 11 to 20 cells; 3 = 21 to 50 cells; and 4 = more than 50 cells. Proportion is reported as percentage of subjects.|Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42|Per Protocol: All randomized patients who received at least one dose of the allocated study medication and had no major protocol deviations, including violation of entry criteria, poor compliance, and use of prohibited medications. Last observation carried forward (LOCF) was performed for missing data.||Percentage of subjects|||Number
827090|NCT01201798|Secondary|Proportion of Subjects With Anterior Chamber Cell Count ≤5 and Flare Grade of 0|Inflammatory cells in the anterior chamber were assessed by the investigator during slit lamp examination and recorded based on actual cell count. Anterior chamber flare (protein escaping from dialated vessels) was assessed by the investigator during slit lamp examination and graded on a 5-point scale, with 0 = none; 1 = mild (trace to clearly noticeable, visible); 2 = moderate; 3 = marked; and 4 = severe. Proportion is reported as percentage of subjects.|Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42|Per Protocol: All randomized patients who received at least one dose of the allocated study medication and had no major protocol deviations, including violation of entry criteria, poor compliance, and use of prohibited medications. Last observation carried forward (LOCF) was performed for missing data.||Percentage of subjects|||Number
827091|NCT01201798|Secondary|Proportion of Subjects With Anterior Chamber Cell Count of 0|Inflammatory cells in the anterior chamber were assessed by the investigator during slit lamp examination and recorded based on actual cell count. Proportion is reported as a percentage of subjects.|Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42|Per Protocol: All randomized patients who received at least one dose of the allocated study medication and had no major protocol deviations, including violation of entry criteria, poor compliance, and use of prohibited medications. Last observation carried forward (LOCF) was performed for missing data.||Percentage of subjects|||Number
827092|NCT01201798|Secondary|Proportion of Subjects With Anterior Chamber Cell Grade of 0|Inflammatory cells in the anterior chamber were assessed by the investigator during slit lamp examination and graded on a 5-point scale, with 0 = ≤ 1 cell count; 1 = 2 to 10 cell count; 2 = 11 to 20 cell count; 3 = 21 to 50 cell count; and 4 = > 50 cell count. Proportion is reported as percentage of subjects.|Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42|Per Protocol: All randomized patients who received at least one dose of the allocated study medication and had no major protocol deviations, including violation of entry criteria, poor compliance, and use of prohibited medications. Last observation carried forward (LOCF) was performed for missing data.||Percentage of subjects|||Number
827093|NCT01201798|Secondary|Change From Baseline (Day 0) in Anterior Chamber Flare Grade at All Time Points|Anterior chamber flare (protein escaping from dialated vessels) was assessed by the investigator during slit lamp examination and graded on a 5-point scale, with 0 = none; 1 = mild (trace to clearly noticeable, visible); 2 = moderate; 3 = marked; and 4 = severe.|Baseline (Day 0), Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42|Per Protocol: All randomized patients who received at least one dose of the allocated study medication and had no major protocol deviations, including violation of entry criteria, poor compliance, and use of prohibited medications. Last observation carried forward (LOCF) was performed for missing data.||Units on a scale||Standard Deviation|Mean
827094|NCT01201798|Secondary|Change From Baseline (Day 0) in Anterior Chamber Cell Grade at All Time Points Other Than Day 14|Inflammatory cells in the anterior chamber were assessed by the investigator during slit lamp examination and graded on a 5-point scale, with 0 = ≤ 1 cell count; 1 = 2 to 10 cell count; 2 = 11 to 20 cell count; 3 = 21 to 50 cell count; and 4 = > 50 cell count.|Baseline (Day 0), Day 3, Day 7, Day 21, Day 28, Day 35, Day 42|Per Protocol: All randomized patients who received at least one dose of the allocated study medication and had no major protocol deviations, including violation of entry criteria, poor compliance, and use of prohibited medications. Last observation carried forward (LOCF) was performed for missing data.||Units on a scale||Standard Deviation|Mean
827095|NCT01201798|Primary|Change From Baseline (Day 0) in Anterior Chamber Cell Grade at Day 14|Inflammatory cells in the anterior chamber were assessed by the investigator during slit lamp examination and graded on a 5-point scale, with 0 = ≤ 1 cell count; 1 = 2 to 10 cell count; 2 = 11 to 20 cell count; 3 = 21 to 50 cell count; and 4 = > 50 cell count.|Baseline (Day 0), Day 14|Per Protocol: All randomized patients who received at least one dose of the allocated study medication and had no major protocol deviations, including violation of entry criteria, poor compliance, and use of prohibited medications. Last observation carried forward (LOCF) was performed for missing data.||Units on a scale||Standard Deviation|Mean
827096|NCT01201811|Secondary|Apparent Volume of Distribution (Vd/F) of Azacitidine|Apparent volume of distribution, was calculated according to the equation: Vd/F = (CL/F)/λz|Timeframe: Day 7 pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 8 hours post-dose|The PK population includes all participants with evaluable azacitidine plasma PK profile.||Liters||Geometric Coefficient of Variation|Geometric Mean
827097|NCT01201811|Secondary|Apparent Total Plasma Clearance (CL/F) of Azacitidine|Apparent total plasma clearance (CL/F) of Azacitidine was calculated as Dose/AUC∞|Timeframe: Days 5 and 6 at predose and Day 7 (pre-dose) at 0.25, 0.5, 1, 2, 3, 4, 6, 8 hours post-dose|The PK population includes all participants with evaluable azacitidine plasma PK profile.||L/hr||Geometric Coefficient of Variation|Geometric Mean
827098|NCT01201811|Secondary|Terminal Phase of Half-life (T1/2) of Azacitidine|The apparent terminal half-life was calculated according to the following equation t½ = 0.693/λz.|Timeframe: Day 7 pre-dose at 0.25, 0.5, 1, 2, 3, 4, 6, 8 hours post-dose|The PK population includes all participants with evaluable azacitidine plasma PK profile.||hours||Geometric Coefficient of Variation|Geometric Mean
827099|NCT01201811|Secondary|Time to Maximum Plasma Concentration (Tmax) of Azacitidine|Time to maximum observed plasma concentration obtained directly from the observed concentration versus time data.|Timeframe: Day 7 pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 8 hours post-dose|The PK population includes all participants with evaluable azacitidine plasma PK profile.||hours||Geometric Coefficient of Variation|Geometric Mean
827100|NCT01201811|Secondary|Maximum Observed Plasma Concentration (Cmax) of Azacitidine|The observed maximum plasma concentration obtained directly from the observed concentration versus time data.|Timeframe: Day 7 pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 8 hours post-dose|The PK population includes all participants with evaluable azacitidine plasma PK profile.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
827101|NCT01201811|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUCt) of Azacitidine|Area under the plasma concentration-time curve from time zero to the last quantifiable time point, calculated by the linear trapezoidal rule when concentrations are increasing and the logarithmic trapezoidal method when concentrations are decreasing.|Timeframe: Day 7 pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 8 hours post-dose|The PK population includes all participants with evaluable azacitidine plasma PK profile.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
827102|NCT01201811|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC∞) of Azacitidine|Area under the plasma concentration-time curve from time zero to infinity (AUC∞) following multiple doses of Azacitidine on Day 7; if possible, the area under the concentration-time curve from time zero to infinity, calculated by the linear trapezoidal rule and extrapolated to infinity was calculated according to the following equation: AUC∞ = AUCt + (Ct/ λz ), where Ct is the last quantifiable concentration. No AUC extrapolation was performed with unreliable λz. If % AUC extrapolated is ≥ 25%, AUC∞ was not reported.|Timeframe: Day 7 pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 8 hours post-dose|The PK population includes all participants with evaluable azacitidine plasma PK profile.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
827103|NCT01201811|Secondary|Number of Participants With Adverse Events (AE)|"An AE that resulted in any of the following outcomes was defined as a serious adverse event (SAE):
Death;
Life-threatening event;
Any inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability or incapacity;
Congenital anomaly or birth defect;
Any other important medical event.
The severity of an AE was evaluated by the investigator according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (Version 4.0) where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death. Treatment Emergent AEs (TEAE) were defined as AEs with an onset date on or after the first dose of study drug and within 28 days after the date of the last dose. In addition, any AE that occurred beyond this timeframe and that was assessed by the investigator as possibly related to study drug was considered a TEAE."|From the first dose of study drug through 28 days after completion of/discontinuation from the study (maximum time on study drug 244 days)|Safety Population included enrolled participants who received at least one dose of investigational product and had at least one postdose assessment||participants|||Number
827104|NCT01201811|Secondary|Number of Infections (Post-baseline Average) Requiring Intravenous Antibiotics, Anti-fungals, or Antivirals Per 28 Days|The on-treatment adverse event of infection requiring IV antibiotics, antifungals, or antivirals per 28 days/cycle. The overall post-baseline average is the average of number of infections requiring IV antibiotics or IV antiviral per 28 days/cycle. For each participant the overall post-baseline average was calculated as the average of # of infections requiring IV antibiotics or IV antiviral per 28 days per cycle.|Up to week 24; The on-treatment period was considered the period from the date of the first dose to the last treatment study visit.|The intent-to-treat (ITT) population was defined as all enrolled participants.||Infections per cycle||Standard Deviation|Mean
827105|NCT01201811|Secondary|Number of Platelet Transfusions by Cycle|The number of transfusions received 56 days prior to treatment and during study was standardized per 28 days and summarized by cycle for platelets. The formula for standardizing per 28 days was: [(# of transfusions in the measurement period / length of the measurement period (days)) x 28], where the measurement period was either baseline or the relevant cycle length. For each participant the overall post-baseline average was calculated as the average of # of platelet transfusions per cycle.|Up to week 24; The on-treatment period was considered the period from the date of the first dose to the last treatment study visit.|The intent-to-treat (ITT) population was defined as all enrolled participants.||Transfusions||Standard Deviation|Mean
827106|NCT01201811|Other Pre-specified|Participants' Platelet Transfusion Status for Participants Who Were Transfusion Independent at Baseline|"A participant was considered platelet transfusion independent at baseline if the participant had no platelet transfusions during the 56 days prior to first dose. During the study, a participant was considered platelet transfusion independent during the on-treatment period if the participant had no platelet transfusions during any 56 consecutive days or more (eg, Days 1 through 56, Days 2 through 57, etc.). Otherwise, they were considered platelet transfusion dependent.
The total N=44, but 1 participant can only be dependent or independent at baseline for each type of transfusion (ie, total = 44: platelet dependent at BL=18, platelet independent at BL=26)"|Baseline to Cycle 6; The on-treatment period was considered the period from the date of the first dose to the last treatment study visit.|The intent-to-treat (ITT) participants who were transfusion independent||percentage of particpants||95% Confidence Interval|Number
827107|NCT01201811|Other Pre-specified|Participants' Platelet Transfusion Status for Participants Who Were Transfusion Dependent at Baseline|"A participant was considered platelet transfusion dependent at baseline if the participant had one or more platelet transfusions during the 56 days prior to first dose. During the study, a participant was considered platelet transfusion independent during the on-treatment period if the participant had no platelet transfusions during any 56 consecutive days or more (eg, Days 1 through 56, Days 2 through 57, etc.). Otherwise, they were considered platelet transfusion dependent.
The total N=44, but 1 participant can only be dependent or independent at baseline for each type of transfusion (ie, total = 44: platelet dependent at BL=18, platelet independent at BL=26)"|Baseline to Cycle 6; The on-treatment period was considered the period from the date of the first dose to the last treatment study visit.|The intent-to-treat (ITT) population who were transfusion dependent||percentage of participants||95% Confidence Interval|Number
827108|NCT01201811|Secondary|Number of Red Blood Cell (RBC) Transfusions by Cycle|The number of transfusions received 56 days prior to treatment and during study were standardized per 28 days and summarized by cycle for RBCs. The formula for standardizing per 28 days was: [(# of transfusions in the measurement period / length of the measurement period (days)) x 28], where the measurement period was either baseline or the relevant cycle length. For each participant the overall post-baseline average was calculated as the average of # of RBC transfusions per cycle.|Up to week 24;The on-treatment period was considered the period from the date of the first dose to the last treatment study visit.|ITT Population- The intent-to-treat (ITT) population was defined as all enrolled participants.||Transfusions||Standard Deviation|Mean
827185|NCT01202253|Secondary|Number of Participants With Infection Sites as Per Microbiological Analysis|Infection sites included blood, chest, urinary tract, intra-abdominal, bile duct, liver, kidney, mouth and esophagus.|Baseline|Full analysis set included all participants who met the defined eligibility criteria.||participants|||Number
827109|NCT01201811|Other Pre-specified|Participants' Red Blood Cell (RBC) Transfusion Status for Participants Who Were Transfusion Independent at Baseline|"A participant was considered RBC transfusion-independent at baseline if the participant had no RBC transfusions during the 56 days prior to first dose. During the study, a participant was considered transfusion independent during the on-treatment period if the participant had no RBC transfusions during any 56 consecutive days or more (eg, Days 1 through 56, Days 2 through 57, etc.). Otherwise, they were considered transfusion dependent.
The total N=44, but 1 participant can only be dependent or independent at baseline for each type of transfusion (ie, total = 44: RBC dependent at BL=32, RBC independent at BL=12)"|Baseline to Cycle 6; The on-treatment period was considered the period from the date of the first dose to the last treatment study visit.|The Intent to Treat (ITT) participants who were transfusion independent||percentage of participants||95% Confidence Interval|Number
827110|NCT01201811|Other Pre-specified|Participants' Red Blood Cell (RBC) Transfusion Status for Participants Who Were Transfusion Dependent at Baseline|"A participant was considered transfusion dependent at baseline if the participant had one or more Red Blood Cell transfusions during the 56 days prior to first dose. During the study, a participant was considered transfusion independent during the on-treatment period if the participant had no transfusions during any 56 consecutive days or more (e.g., Day 1 through 56, Day 2 through 57, etc). Otherwise, they were considered transfusion dependent.
The total N=44, but 1 participant can only be dependent or independent at baseline for each type of transfusion (ie, total = 44: RBC dependent at BL=32, RBC independent at BL=12)"|Baseline to Cycle 6; The on-treatment period was considered the period from the date of the first dose to the last treatment study visit|The intent-to-treat (ITT) participants who were transfusion dependent||percentage of participants||95% Confidence Interval|Number
827111|NCT01201811|Primary|Percentage of Participants Showing Hematologic Improvement Using International Working Group (IWG Criteria for Hematologic Improvement Cheson 2000) Criteria for Myelodysplastic Syndrome (MDS) and Assessed by Sponsor|"Hematologic improvements (HI) have 4 categories:
Erythroid response (HI-E): Major >20g/L increase or transfusion independent. Minor- 10-20g/L increase or ≥50% decrease in transfusion requirements.
Platelet response (HI-P): Major absolute increase of ≥30x10^9/L or platelet transfusion independence. Minor-≥50% increase.
Neutrophil response (HI-N): Major 100% increase or an absolute increase of >0.5x10^9/L. Minor-≥100% increase and absolute increase of <0.5x10^9/L
Progression or relapse after HI
Overall hematological improvement (HI) was defined as any type (major or minor) of improvement of HI-E, HI-P, or HI-N. Criteria: Pretreatment=hemoglobin <100g/L or RBC transfusion-dependent, platelet count <100x10^9/L or platelet transfusion dependent, absolute neutrophil count <1.5x10^9/L. Sponsor’s determination was derived using clinically relevant data.
Denominator for progression/relapse after HI included participants who had achieved HI."|Response assessed at end of cycle 6; through week 24; End of study|The intention-to-treat (ITT) population was defined as all enrolled participants||percentage of participants||95% Confidence Interval|Number
827112|NCT01201811|Primary|Percentage of Participants With a Hematologic Response Using International Working Group (IWG) Criteria for Myelodysplastic Syndrome (MDS) and Assessed by Investigator|"Hematologic Response according to the 2000 International Working Group (IWG) response criteria for MDS was based on the Investigators determination and defined as:
Complete Response (CR): repeat bone marrow (BM) shows <5% myeloblasts, and peripheral blood values lasting ≥ 2 months of hemoglobin (hgb) (>110 g/L), neutrophils (≥1.5x10^9/L), platelets (≥100x10^9/L), blasts (0%) and no dysplasia
Partial Response (PR): same as CR for peripheral blood: BM shows blasts decrease by ≥ 50% or a less advanced FAB classification from pretreatment
Stable disease (SD): failure to achieve a PR, no evidence of progression for at least 2 months.
Failure: death during treatment or disease progression
Relapse After CR or PR: return to pretreatment BM blast percent or decrement of ≥ 50% from remission/response levels in granulocytes or platelets; or reduction in hgb by ≥20 g/L or transfusion dependence
Disease Progression: change in blast levels
Disease Transformation to AML"|Response assessed at end of cycle 6; through week 24; End of study|The intention-to-treat (ITT) population was defined as all enrolled participants||percentage of participants||95% Confidence Interval|Number
827113|NCT01201915|Secondary|Time to Complete Clinical Clearance|Time to complete clinical clearance was defined as the time from the first treatment with vismodegib until complete clinical clearance as determined by the investigator.|Baseline to the end of the study (up to 12 weeks for Cohort 1; up to 36 weeks for Cohort 2, up to 20 weeks for Cohort 3)|Efficacy evaluable population: All participants who were treated with at least 1 dose of study drug. Only participants who achieved complete clinical clearance were included in the analysis.||Days||95% Confidence Interval|Median
827114|NCT01201915|Primary|Percentage of Participants With Complete Histologic Clearance|Complete histologic clearance was defined as the absence of histological evidence of basal cell carcinoma at the target tumor site. Histological examination was performed by an independent pathologist on specimens collected within 2 weeks of the end of treatment period, ie, at 12 weeks after Baseline in Cohort 1, at 36 weeks after Baseline in Cohort 2, and at 20 weeks after Baseline in Cohort 3.|Baseline to Week 12 (Cohort 1), Baseline to Week 36 (Cohort 2), Baseline to Week 20 (Cohort 3)|Efficacy evaluable population: All participants who were treated with at least 1 dose of study drug.||Percentage of participants||95% Confidence Interval|Number
827115|NCT01201967|Secondary|Change in Physical Health-related Quality of Life From Baseline to 24 Weeks|Physical health-related quality of life is measured with the Short Form-12 Physical Component Score (SF-12 PCS). The SF-12 PCS a 6-item scale that assesses physical health-related quality of life. Each question provides the option of 2-6 answers. Some questions are Yes/No (2 options), while others ask how often something occurs (6 options, etc.). Scores are calculated using a formula and can range from 0 to 100. A score of 50 indicates average physical health-related quality of life. Higher scores represent higher than average physical health-related quality of life, and lower scores represent lower physical health-related quality of life.|Baseline, 24 weeks|||units on a scale||95% Confidence Interval|Mean
827116|NCT01201967|Secondary|Change in Physical Function From Baseline to 24 Weeks|Physical function is measured with the Duke Activity Status Index (DASI). The DASI is a 12-item scale that measures physical function. Each question asks about whether the subject can complete a physical activity and are given the following options: Scores range from 0 to 58.2. Lower scores indicate lower levels of physical function.|Baseline, 24 weeks|92 participants in the Collaborative Care group were compared to 91 participants in the Usual Care group.||units on a scale||95% Confidence Interval|Mean
827117|NCT01201967|Secondary|Change in Health Status From Baseline to 24 Weeks|Health status measured by the Euro Quality of Life-5 Domain (EQ5D). The EQ5D is a 5-item scale that assesses quality of life. Each question asks about difficulties with certain areas of health (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and offer three possible answers: No problems, Moderate problems, Extreme problems. Scores can range from 0.000-1.000, with lower scores indicating less quality of life, and higher scores indicating higher quality of life.|Baseline, 24 weeks|92 participants in the Collaborative Care group were compared to 91 participants in the Usual Care group.||units on a scale||95% Confidence Interval|Mean
827118|NCT01201967|Secondary|Number of Rehospitalizations From Baseline to 24 Weeks|The number of rehospitalizations from baseline to 24 weeks was measured by contacting subjects' medical providers at 24 weeks and by asking subjects about rehospitalizations during each follow-up phone call.|24 weeks|||readmissions|||Number
827119|NCT01201967|Secondary|Change in Adherence to Health Behaviors From Baseline to 24 Weeks|Adherence to health behaviors is measured with the Medical Outcome Study Specific Adherence Scale (MOS-SAS). The MOS-SAS is a 3-item scale used to assess medication adherence, physical activity adherence, and diet adherence. Each question asks how often the subject adheres to the behavior, providing the following options: 1 = None of the time, 2 = A little of the time, 3 = Some of the time, 4 = A good bit of the time, 5 = Most of the time, 6 = All of the time. Scores are totaled and range from (3 to 18). A low score indicates poorer adherence to healthy behaviors.|Baseline, 24 weeks|92 participants in the Collaborative Care group were compared to 91 participants in the Usual Care group.||units on a scale||95% Confidence Interval|Mean
827120|NCT01201967|Secondary|Rate of Adequate Treatment of Depression and/or Anxiety Symptoms 5 Days After Enrollment|"Adequate treatment was defined as:
(1) Prescription of a standard dose of an established first-line treatment for depression, generalized anxiety disorder, or panic disorder, and/or (2) referral to evidence-based psychotherapy (either to an outside mental health provider or a Cognitive Behavioral Therapy workbook in the Collaborative Care arm of the study).
Patients already engaged in #1 and/or #2 at the time of enrollment had a different process. Subjects must have been engaged in at least 4 weeks of treatment prior to enrollment while still meeting criteria for the disorder. For this population, adequate treatment was defined as:
(1) Prescription dose increase/augmentation/switch, and/or (2) referral to psychotherapy (either to an outside mental health provider or a Cognitive Behavioral Therapy workbook in the Collaborate Care arm).
Timeframe of 5 days after enrollment was determined by calculating the median length of hospitalization for all subjects."|5 days after enrollment|92 participants in the Collaborative Care group were compared to 91 participants in the Usual Care group.||participants|||Number
827121|NCT01201967|Secondary|Change in Anxiety Symptoms From Baseline to 24 Weeks|Anxiety symptoms measured with the Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A). The HADS-A is a 7-item scale used to measure anxiety severity. Each question asks about a specific symptom of anxiety and offers four answers: 0 = Never / Not at all, 1 = A little / Time to time, 2 = Quite often / Usually, 3 = Most of the time / Very often. Scores are totaled and range from 0-21. A higher score means more anxiety.|Baseline, 24 weeks|92 participants in the Collaborative Care group were compared to 91 participants in the Usual Care group.||units on a scale||95% Confidence Interval|Mean
827122|NCT01201967|Secondary|Change in Depression Symptoms From Baseline to 24 Weeks|Depression symptoms measured by the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a 9-item scale that measures depression severity. Each question asks how often the subject experiences symptoms of depression and offers four answers: 0 = Not at all, 1 = Several days, 2 = More than half the days, 3 = Nearly every day. Scores are totaled and range from 0-27. To be considered depressed, subjects had to (a) have a total score of 10 or more, (b) answer five questions with a score of 2 or 3, and (c) one of the five questions had to be question 1 or question 2 (or both). Anyone who did not meet these criteria were not considered depressed.|Baseline, 24 weeks|92 participants in the Collaborative Care group were compared to 91 participants in the Usual Care group.||units on a scale||95% Confidence Interval|Mean
827123|NCT01201967|Primary|Change in Mental Health-related Quality of Life From Baseline to 24 Weeks|Mental health-related quality of life is measured by the Short Form-12 Mental Component Score (SF-12 MCS). The SF-12 MCS is a 6-item scale that assesses mental health-related quality of life. Each question provides the option of 2-6 answers. Some questions are Yes/No (2 options), while others ask how often something occurs (6 options, etc.). Scores are calculated using a formula and can range from 0 to 100. A score of 50 indicates average mental health-related quality of life. Higher scores represent higher than average mental health-related quality of life, and lower scores represent lower mental health-related quality of life.|Baseline, 24 weeks|92 participants in the Collaborative Care group were compared to 91 participants in the Usual Care group.||units on a scale||95% Confidence Interval|Mean
827124|NCT01202071|Secondary|Pharmacokinetic Parameter: Area Under the Plasma Concentration-Time Curve From Time 0 to Time t (AUC[0-t])|"Pharmacokinetic parameter: Area under the plasma concentration-time curve from time 0 (administration of the drug) to time t (the last quantifiable concentration time point). AUC measured in nanogram hours per milliliter (ng*h/mL) was calculated on Day 1 and Day 5 of administration during each Period (I-IV).
Data was displayed based on the participant's CYP2C19 genotype: CYP2C19-EM are extensive metabolizers who have normal metabolizing capacity. CYP2C19-PM are poor metabolizers with a metabolizing capacity deficiency or remarkably decreased metabolizing capacity."|Day 1 and Day 5 of administration during Period I-IV (0, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 24 hours post-dose)|||ng*h/mL||Standard Deviation|Mean
827125|NCT01202071|Secondary|Pharmacokinetic Parameter: Maximal Drug Concentration (Cmax)|"Pharmacokinetic parameter: maximal drug concentration (Cmax) measured in nanograms per milliliter (ng/mL) was calculated on Day 1 and Day 5 of administration during each Period (I-IV).
Data was displayed based on the participant's CYP2C19 genotype: CYP2C19-EM are extensive metabolizers who have normal metabolizing capacity. CYP2C19-PM are poor metabolizers with a metabolizing capacity deficiency or remarkably decreased metabolizing capacity."|Day 1 and Day 5 of administration during Period I-IV|||ng/mL||Standard Deviation|Mean
827126|NCT01202071|Primary|Percentage Duration With An Intragastric pH >= 4 During The Entire 24 Hours Of Day 5 Administration|The 24-hour intragastric pH monitoring was performed on Day 5 of administration in each study period (Period I-IV). Data was displayed based on the participant's CYP2C19 genotype: CYP2C19-EM are extensive metabolizers who have normal metabolizing capacity. CYP2C19-PM are poor metabolizers with a metabolizing capacity deficiency or remarkably decreased metabolizing capacity.|Day 5 of administration during Period I-IV|||Percentage of Time in a 24 Hour Period||Standard Deviation|Mean
827127|NCT01202110|Primary|Determine in Patients With Traumatic Brain Injury (TBI) the Safe Dosing of Early Propranolol.|The primary outcome is to determine the safety of early propranolol treatment after TBI by recording the number of episodes of bradycardia (heart rate < 60 beats per minute), hypotension (defined as systolic blood pressure < 90) or decreased cerebral perfusion pressure (defined as CPP less than 60mmHg) refractive to treatment.|24 months|Terminated prior to enrolling|||||
827128|NCT01202162|Secondary|Quality of Recovery 40|Survey completion at 24 hours post surgery of the Quality of Recovery 40 questionnaire.This questionnaire asks 40 questions in 5 categories of recovery. The scores are combined from each group and are used as a composite score. The scores range from a low of 40 to a high of 200. A score of 40 would indicate a poor quality of recovery where as a score of 200 would be a good quality of recovery at 24 hours postoperative.|1 day|In the Desflurane group 35 completed the survey 24 hours postoperative where as 33 in the Sevoflurane completed the survey during the postoperative period.||score (between 40 low-200 high)||Inter-Quartile Range|Median
827129|NCT01202162|Secondary|Number of Participants Who Coughed||Perioperative|||participants|||Number
827130|NCT01202162|Primary|Time to Awakening||Time inhalational agent is turned off to time of patient awakening|||Elapsed time in minutes||Inter-Quartile Range|Median
827131|NCT01202188|Secondary|Percentage of Participants With COPD Exacerbations Requiring Hospitalization or Treatment With Systemic Corticosteroids and/or Antibiotics But no Hospitalization||26 Weeks|Full Analysis Set included all randomized participants who received at least one dose of study drug.||Percentage of participants|||Number
827132|NCT01202188|Secondary|Percentage of Patients With at Least One Moderate or Severe COPD Exacerbation Over the 26 Week Treatment Period||26 Weeks|Full Analysis Set includes all randomized participants who received at least one dose of study drug.||Percentage of participants|||Number
827133|NCT01202188|Secondary|Rate of Moderate or Severe COPD Exacerbation|Rate of moderate or severe exacerbations per year = total number of moderate or severe exacerbations / total number of treatment years|26 Weeks|||Exacerbations per year|||Number
827134|NCT01202188|Secondary|24 Hour Holter Monitoring in a Subset of Patients|"24-hourly mean heart rate was performed using a Holter Monitor at Weeks 12 and 26 in a subgroup of patients. Mixed model: heart rate = treatment + baseline heart rate + baseline smoking status + baseline ICS use + region + center (region) + error. Center was included as a random effect nested within region.
The 24-hourly mean heart rate is the mean heart rate over the 24 hour period, derived using hourly mean heart rate beats per minute."|Week 12, Week 26|Safety Set Holter Group-a subset of the Safety participants that included all randomized participants who received at least one dose of study drug and participated in the 24 hour Holter monitoring with evaluable data available for analysis. No participants in the Titotropium arm participated in the Holter Monitoring.||beats per minute||Standard Error|Least Squares Mean
827135|NCT01202188|Secondary|Standardized FEV1 (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 23 Hours 45 Minutes at Week 26|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5, 15, and 30 minutes; and 1, 2, 4, 8, 12, 23 hours 15 minutes and 23 hours 45 minutes post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time. A mixed model was used with treatment as a fixed effect with baseline FEV1 and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.|From 5 minutes to 23 hours 45 minutes post-dose Week 26|Participants from the 24 hour serial spirometry subset of the full analysis set (all randomized participants who received study drug) with data available for analysis. Data within 6 hours of rescue medication use or 7 days of systemic corticosteroid use is excluded from the analysis.||Liters||Standard Error|Least Squares Mean
827136|NCT01202188|Secondary|Standardized FEV1 (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 12 Hours at Day 1 and Week 26|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5, 15, and 30 minutes; and 1, 2, 4, 8, 12 hours post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time. A mixed model was used with treatment as a fixed effect with baseline FEV1 and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.|From 5 minutes to 12 hours post-dose Day 1 and Week 26|Participants from the 24 hour serial spirometry subset of the full analysis set (all randomized participants who received study drug) with data available for analysis. Data within 6 hours of rescue medication use or 7 days of systemic corticosteroid use is excluded from the analysis.||Liters||Standard Error|Least Squares Mean
827137|NCT01202188|Secondary|Standardized FEV1 (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours at Day 1 and Week 26|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5, 15, and 30 minutes; and 1, 2, and 4 hours post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time. A mixed model was used with treatment as a fixed effect with baseline FEV1 and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.|From 5 minutes to 4 hours post-dose Day 1 and Week 26|Participants from full analysis set, all randomized participants who received study drug, with data available for analysis. Data within 6 hours of rescue medication use or 7 days of systemic corticosteroid use is excluded from analysis.||Liters||Standard Error|Least Squares Mean
827159|NCT01202227|Primary|Number of Participants With Deterioration in Neurological Examination Findings|Worsening of the condition relative to baseline was reported as deteriorated. Assessment categories are as follows: normal or abnormal for Cranial Nerve Function, Mental State, and Coordination; normal, mild, moderate, or severe ataxia for Gait; none/absent, normal, or hyper-reflexic for Deep Tendon Reflexes; absent or present for Abnormal Reflexes; normal, mild, moderate, or severe weakness for Muscle Strength; slight, more marked, or considerable increase, or affected parts rigid in flexion or extension for Muscle Tone; absent or present for Sensory Function.|53 weeks|The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.||Participants|||Number
827138|NCT01202188|Secondary|"Percentage of Days With no Rescue Medication Use Over 26 Weeks"|A day with no rescue medication use is defined from the diary data as any day where the patient recorded no rescue medicine use during the previous 12 hours. The percentage of days is calculated by the number of days with no rescue medicine use/total number of days with evaluable data X 100. A mixed model was used with treatment as a fixed effect with baseline number of puffs and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.|26 Weeks|Participants from the full analysis set (all randomized participants who received at least one dose of study drug) with evaluable data (at least 40 days of diary data) available for analysis.||Percentage of days||Standard Error|Least Squares Mean
827139|NCT01202188|Secondary|Change From Baseline (BL) in the Daytime and Night Time Rescue Medication Use (Number of Puffs) Over 26 Weeks|The number of puffs of rescue medication taken in the previous 12 hours was record in patient diary in the morning and in the evening for 26 weeks. The total number of puffs in the morning and evening were calculated and divided by the number of days with data to determine the mean daily number of daytime and nighttime puffs. A mixed model was used with treatment as a fixed effect with baseline number of puffs and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline (BL) ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.|Baseline, Week 26|Participants from the full analysis, consisting of all randomized participant who received study drug, with data available for analysis.||Puffs||Standard Error|Least Squares Mean
827140|NCT01202188|Secondary|Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication at Week 12 and Week 26|The number of puffs of rescue medication taken in the previous 12 hours was record in patient diary in the morning and in the evening for 26 weeks. The total number of puffs per day was calculated and divided by the number of days with data to determine the mean daily number of puffs of rescue medication for each patient. Rescue medication data recorded during the 14 day run-in was used to calculate the baseline. A negative change from baseline indicates improvement. A mixed model was used with treatment as a fixed effect with baseline number of puffs and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.|Baseline, Week 12, Week 26|Participants from the full analysis, consisting of all randomized participant who received study drug, with data available for analysis at Week 12 and Week 26.||Puffs per day||Standard Error|Least Squares Mean
827141|NCT01202188|Secondary|"Percentage of Days Able to Perform Usual Daily Activities Over 26 Weeks"|"Patients answered the question Did your respiratory symptoms stop you performing your usual activities today?-Not at all in their daily diary. The percentage of days is calculated by the number of days patient is able to perform daily activities/total number of days with evaluable data X 100. A mixed model was used with treatment as a fixed effect with baseline Percent of Days and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect."|26 Weeks|Participants from the Full Analysis Set, all randomized participants who received study drug, with evaluable diary data (at least 40 days) for analysis.||Percentage of days||Standard Error|Least Squares Mean
827142|NCT01202188|Secondary|"Percentage of Days With No Daytime Symptoms Over 26 Weeks"|A day with no day time symptoms is defined from the diary data as any day where the patient recorded no coughing, no wheezing, no sputum production and no breathlessness during the previous 12 hours (approximately 8AM to 8PM). The percentage of days is calculated by the number of days with no daytime symptoms/total number of days with evaluable data X 100. A mixed model was used with treatment as a fixed effect with baseline Percent of days and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.|26 Weeks|Participants from the Full Analysis Set, all randomized participants who received study drug, with evaluable diary data (at least 40 days) for analysis.||Percentage of days||Standard Error|Least Squares Mean
827143|NCT01202188|Secondary|"Percentage of Nights With No Night Time Awakenings Over 26 Weeks"|A day with no night time awakenings is defined from the diary data as any day where the patient did not wake up due to COPD symptoms. The percentage of nights is calculated by the number of days with no nighttime awakenings/total number of days with evaluable data X 100. A mixed model was used with treatment as a fixed effect with baseline Percent days and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.|26 Weeks|Participants from the Full Analysis Set, all randomized participants who received study drug, with evaluable diary data (at least 40 days) for analysis.||Percentage of nights||Standard Error|Least Squares Mean
827144|NCT01202188|Secondary|Percentage of Patients With a Clinically Important Improvement From Baseline of at Least 4 Units in the SGRQ Total Score After 26 Weeks of Treatment|SGRQ is a health related quality of life questionnaire consisting of 51 items in three areas: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). The total score is 0 to 100 with a higher score indicating poorer health status.|Baseline, Week 26|Participants from the Full Analysis Set, that included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward but not more than 14 weeks and data within 4 weeks of day 1 were not carried forward.||Percentage of participants|||Number
827201|NCT01202253|Secondary|Percentage of Participants With Documented Eradication of Infecting Species|Documented microbial eradication was defined as 2 negative follow-up blood cultures for bloodstream infections.|Baseline|Data was not analyzed as the study was retrospective and data for eradication of candida infection was not documented in the participants’ medical notes.|||||
827145|NCT01202188|Secondary|St. George's Respiratory Questionnaire (SGRQ) Total Score After 12 and 26 Weeks of Treatment|SGRQ is a health related quality of life questionnaire consisting of 51 items in three areas: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). The total score is 0 to 100 with a higher score indicating poorer health status. A mixed model was used with treatment as a fixed effect with Baseline SGRQ and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.|Week 12, Week 26|Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward but not more than 14 weeks and data within 4 weeks of day 1 were not carried forward.||Score on a scale||Standard Error|Least Squares Mean
827146|NCT01202188|Secondary|Percentage of Patients With a Clinically Important Improvement of at Least 1 Point in TDI Focal Score After 26 Weeks of Treatment|A trained assessor interviewed the patient and graded the degree of impairment due to dyspnea (difficulty breathing) at Week 12 and Week 26. TDI focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort. The BDI (baseline) was measured at Day 1. The TDI captures changes from baseline. Each domain is scored from -3 (major deterioration) to 3 (major improvement) to give an overall TDI focal score of -9 to 9.|Baseline, Week 26|Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward.||Percentage of participants|||Number
827147|NCT01202188|Secondary|Baseline Transitional Dyspnea Index (BDI/TDI) Focal Score at Week 12 and Week 26|"A trained assessor interviewed the patient and graded the degree of impairment due to dyspnea (difficulty breathing). BDI/TDI focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort and captures changes from baseline. BDI was measured at day 1 prior to the first dose with domain scores ranging from 0=very severe to 4=no impairment and a total score ranging from 0 to 12(best). TDI captures changes from baseline. Each domain is scored from -3=major deterioration to 3=major improvement to give an overall TDI focal score of -9 to 9. Higher numbers indicate a better score.
A mixed model was used with treatment as a fixed effect with Baseline Dyspnea Index Score and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators as covariates and included baseline smoking status, baseline inhaled corticosteroids and region as fixed effects with center nested within region as a random effect."|Baseline, Week 12, Week 26|Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward but not more than 14 weeks and data within 4 weeks of day 1 were not carried forward.||Score on a scale||Standard Error|Least Squares Mean
827148|NCT01202188|Secondary|Trough Forced Expiratory Volume In One Second (FEV1) After 26 Weeks of Treatment With QVA149 Compared to Tiotropium|Spirometry was performed according to internationally accepted standards. Trough FEV1 was defined as the mean of the 23 hour 15 minute and 23 hour 45 minute post-dose values. A mixed model was used with treatment as a fixed effect with baseline FEV1 and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.|23 hours 15 minutes and 23 hour 45 minute post-dose Week 26|Participants from the Per-protocol Set, randomized participants who received at least one dose of study drug without major protocol deviations. Data was imputed with last observation carried forward. Data within 6 hours of rescue medication use or 7 days of systemic corticosteroid use is excluded from the analysis.||Liters||Standard Error|Least Squares Mean
827149|NCT01202188|Secondary|Trough Forced Expiratory Volume In One Second (FEV1) After 26 Weeks of Treatment With QVA149, QAB149 and NVA237 Compared to Placebo|Spirometry was performed according to internationally accepted standards. Trough FEV1 was defined as the mean of the 23 hour 15 minute and 23 hour 45 minute post-dose values. A mixed model was used with treatment as a fixed effect with baseline FEV1 and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.|23 hours 15 minutes and 23 hour 45 minute post-dose Week 26|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis. Data was imputed with last observation carried forward. Data within 6 hours of rescue medication use or 7 days of systemic corticosteroid use is excluded from the analysis.||Liters||Standard Error|Least Squares Mean
827150|NCT01202188|Secondary|Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication Over 26 Weeks|The number of puffs of rescue medication taken in the previous 12 hours was record in patient diary in the morning and in the evening for 26 weeks. The total number of puffs per day was calculated and divided by the number of days with data to determine the mean daily number of puffs of rescue medication for each patient. Rescue medication data recorded during the 14 day run-in was used to calculate the baseline. A negative change from baseline indicates improvement. A mixed model was used with treatment as a fixed effect with baseline number of puffs and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.|Baseline, Week 26|Participants from the full analysis, consisting of all randomized participant who received study drug, with data available for analysis.||Puffs per day||Standard Error|Least Squares Mean
827160|NCT01202227|Primary|Number of Participants With Visual Field Deteriorated|Number of participants who had normal visual field at baseline and showed abnormal result after the study treatment, assessed by confrontational visual field test (neurological examination).|53 weeks|The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.||Participants|||Number
836709|NCT01299961|Secondary|12 Month Change in Power Doppler Ultrasound (PDUS) Scores|There were seven different joints in the hands and wrists evaluated to score the PDUS.|baseline, 12 months|As stated previously||units on a scale||Standard Deviation|Mean
827151|NCT01202188|Secondary|St. George’s Respiratory Questionnaire (SGRQ) Total Score at Week 26|SGRQ is a health related quality of life questionnaire consisting of 51 items in three areas: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). The total score is 0 to 100 with a higher score indicating poorer health status. A mixed model was used with treatment as a fixed effect with Baseline SGRQ and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.|26 weeks|Participants from the Full Analysis Set,included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward but not more than 14 weeks and data within 4 weeks of day 1 were not carried forward.||Score on a scale||Standard Error|Least Squares Mean
827152|NCT01202188|Secondary|Transitional Dyspnea Index (TDI) Focal Score at Week 26|A trained assessor interviewed the patient and graded the degree of impairment due to dyspnea (difficulty breathing). TDI focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort. Each domain is scored from -3 (major deterioration) to 3 (major improvement) to give an overall TDI focal score of -9 to 9. Higher numbers indicate a better score. A mixed model was used with treatment as a fixed effect with Baseline Dyspnea Index Score and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.|Week 26|Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward.||Score on a scale||Standard Error|Least Squares Mean
827153|NCT01202188|Primary|Trough Forced Expiratory Volume In One Second (FEV1) After 26 Weeks of Treatment|Spirometry was performed according to internationally accepted standards. Trough FEV1 was defined as the mean of the 23 hour 15 minute and 23 hour 45 minute post-dose values. A mixed model was used with treatment as a fixed effect with baseline FEV1 and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.|23 hours 15 minutes and 23 hour 45 minute post-dose Week 26|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis. Data was imputed with last observation carried forward. Data within 6 hours of rescue medication use or 7 days of systemic corticosteroid use is excluded from the analysis.||Liters||Standard Error|Least Squares Mean
827154|NCT01202227|Secondary|Change From Baseline in the Modified Brief Pain Inventory (10 Item) (mBPI-10)Total Scores at Last Evaluation Score|"The mBPI-10 is a self administered questionnaire that assesses pain interference with functional activities over the past week. These items are measured on an 11 point scale, ranging from “does not interfere” (0) to “completely interferes” (10). A composite score, the Pain Interference Index, will be calculated by averaging the 10 items that comprise the scale.
Change = observation mean at Week 52 minus baseline mean."|Baseline, Week 52|"The full analysis set consists of all participants who received at least one dose of study medication in this long-term study and for whom post-treatment data were available.
The number of participants who had mBPI at Week 52/ Early Termination was 101 participants (n=101)."||Score on a scale||95% Confidence Interval|Mean
827155|NCT01202227|Secondary|Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Affective Scores|"The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe.
Range: 0 to 12 for affective score. Change = observation mean minus baseline mean. Negative change indicated improvement."|Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52|The full analysis set consists of all participants who received at least one dose of study medication in this long-term study and for whom post-treatment data were available. For study endpoint of efficacy (Week 52), missing values was imputed with the last observation carried forward (LOCF).||Score on a scale||95% Confidence Interval|Mean
827156|NCT01202227|Secondary|Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Sensory Scores|"The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe.
Range: 0 to 33 for sensory score. Change = observation mean minus baseline mean. Negative change indicated improvement."|Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52|The full analysis set consists of all participants who received at least one dose of study medication in this long-term study and for whom post-treatment data were available. For study endpoint of efficacy (Week 52), missing values was imputed with the last observation carried forward (LOCF).||Score on a scale||95% Confidence Interval|Mean
827157|NCT01202227|Secondary|Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Total Scores|"The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe.
Range: 0 to 45 for total score. Change = observation mean minus baseline mean. Negative change indicated improvement."|Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52|The full analysis set consists of all participants who received at least one dose of study medication in this long-term study and for whom post-treatment data were available. For study endpoint of efficacy (Week 52), missing values was imputed with the last observation carried forward (LOCF).||Score on a scale||95% Confidence Interval|Mean
827158|NCT01202227|Primary|Number of Participants With Suicidal Ideation According to Sheehan Suicidality Tracking Scale (Sheehan-STS)|The Sheehan-STS is an 8-item prospective rating scale that tracks treatment-emergent suicidal ideation and behaviors. Participants who reported a score of ≥1 (5-point scale ranging from 0: not at all to 4: extremely) for Item 2, 3, 4 or 5 of the Sheehan-STS prognostic scale is considered to have suicidal ideation as the scores are mapped to Category 4 (suicide ideation) of the Columbia Classification Algorithm of Suicide Assessment.|Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52|The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.||Participants|||Number
827161|NCT01202227|Primary|Number of Participants With Skin Redness Related to Deep Vein Thrombosis (DVT)|DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe.|Baseline, Weeks 4, 20, 36, 52, and 53|The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.||Participants|||Number
827162|NCT01202227|Primary|Number of Participants With Collateral Superficial Veins (Non-varicose) Related to Deep Vein Thrombosis (DVT)|DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe.|Baseline, Weeks 4, 20, 36, 52, and 53|The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.||Participants|||Number
827163|NCT01202227|Primary|Number of Participants With Pitting Edema Related to Deep Vein Thrombosis (DVT)|DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe.|Baseline, Weeks 4, 20, 36, 52, and 53|The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.||Participants|||Number
827164|NCT01202227|Primary|Number of Participants With Swelling Related to Deep Vein Thrombosis (DVT)|DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe.|Baseline, Weeks 4, 20, 36, 52, and 53|The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.||Participants|||Number
827165|NCT01202227|Primary|Number of Participants With Localized Tenderness Related to Deep Vein Thrombosis (DVT)|DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe.|Baseline, Weeks 4, 20, 36, 52, and 53|The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.||Participants|||Number
827166|NCT01202227|Primary|Number of Participants With Localized Pain Related to Deep Vein Thrombosis (DVT)|DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe.|Baseline, Weeks 4, 20, 36, 52, and 53|The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.||Participants|||Number
827167|NCT01202227|Primary|Number of Participants With Generalized or Abdominal Edema|Number of participants who had generalized or abdominal edema.|Baseline, Weeks 4, 20, 36, 52, and 53|The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.||Participants|||Number
827168|NCT01202227|Primary|Number of Participants With Facial/Periorbital Edema|Number of participants who had facial or periorbital edema.|Baseline, Weeks 4, 20, 36, 52, and 53|The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.||Participants|||Number
827169|NCT01202227|Primary|Number of Participants With Peripheral Edema|Number of participants who had peripheral edema in lower extremities. Edema was categorized as follows: trace, pitting 1 (lower leg), 2 (lower leg to knee), and 3 (above knee and /or presacral edema).|Baseline, Weeks 4, 20, 36, 52, and 53|The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.||Participants|||Number
827170|NCT01202253|Secondary|Number of Participants With Different Types of Drug-related Serious Adverse Events||Baseline up to Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria.||participants|||Number
827171|NCT01202253|Secondary|Percentage of Participants With One or More Drug-related Serious Adverse Events (SAEs)||Baseline up to Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria.||percentage of participants|||Number
827172|NCT01202253|Secondary|Number of Serious Adverse Events (SAEs)|Any untoward medical occurrence in a participant who received study treatment was considered an adverse event (AE) without regard to possibility of causal relationship. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a SAE: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria.||events|||Number
827173|NCT01202253|Secondary|Duration of Anidulafungin Therapy||Baseline|Full analysis set included all participants who met the defined eligibility criteria.||days||Standard Deviation|Mean
827174|NCT01202253|Secondary|Number of Participants With Other Dosing Patterns|The other dosing patterns for anidulafungin included any dosing pattern different from 200 mg loading dose on Day 1 followed by 100 mg doses subsequently starting from Day 2.|Baseline up to Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria.||participants|||Number
827175|NCT01202253|Secondary|Percentage of Participants Who Received 200 mg Dose on Day 1 and 100 mg for All Subsequent Doses||Baseline up to Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria.||percentage of participants||95% Confidence Interval|Number
827186|NCT01202253|Secondary|Percentage of Participants With Systolic Blood Pressure More Than 2 Standard Deviations Below the Mean for Age Recorded Within 24 Hour Period Prior to Initiation of Drug Therapy|Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 by standard calculations (outside the valid range of 0 to 100).|Baseline|Full analysis set included all participants who met the defined eligibility criteria.||percentage of participants||95% Confidence Interval|Number
827187|NCT01202253|Secondary|Percentage of Participants With Documented Body Temperature Above 38.0 Degree Celsius or Below 36.0 Degree Celsius Within 24 Hour Period Prior to Initiation of Drug Therapy|Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 and upper limit of confidence interval was reported as 100 if the same was calculated as greater than 100, by standard calculations (outside the valid range of 0 to 100).|Baseline|Full analysis set included all participants who met the defined eligibility criteria.||percentage of participants||95% Confidence Interval|Number
827188|NCT01202253|Secondary|Percentage of Participants With Probable or Proven Fungal Infection at the Initiation of Drug Therapy||Baseline|Full analysis set included all participants who met the defined eligibility criteria.||percentage of participants||95% Confidence Interval|Number
827189|NCT01202253|Secondary|Dose Changes for Immunosuppressant Drugs||Baseline up to Day 28 post-treatment|Data was not analyzed as the study was retrospective and data for dose change for immunosuppressant drugs was not available.|||||
827190|NCT01202253|Secondary|Percentage of Participants Prescribed With Systemic Antifungal Within 30 Days Before Study Start|Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 by standard calculations (outside the valid range of 0 to 100).|Baseline|Full analysis set included all participants who met the defined eligibility criteria.||percentage of participants||95% Confidence Interval|Number
827191|NCT01202253|Secondary|Percentage of Participants With Concomitant Bacterial or Viral Infection|Upper limit of confidence interval was reported as 100 if the same was calculated as greater than 100 by standard calculations (outside the valid range of 0 to 100).|Baseline|Full analysis set included all participants who met the defined eligibility criteria.||percentage of participants||95% Confidence Interval|Number
827192|NCT01202253|Secondary|Percentage of Participants With Absolute Neutrophil Count Less Than 500 Per Cubic Millimeter (/mm^3) and Greater Than or Equal to 500 /mm^3|Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 and upper limit of confidence interval was reported as 100 if the same was calculated as greater than 100, by standard calculations (outside the valid range of 0 to 100).|Baseline|Full analysis set included all participants who met the defined eligibility criteria.||percentage of participants||95% Confidence Interval|Number
827193|NCT01202253|Secondary|Duration of Stay at Liver Intensive Therapy Unit (LITU)||Baseline up to Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||days||Inter-Quartile Range|Mean
827194|NCT01202253|Secondary|Percentage of Participants Admitted to Liver Intensive Therapy Unit (LITU)||Baseline|Full analysis set included all participants who met the defined eligibility criteria.||percentage of participants||95% Confidence Interval|Number
827195|NCT01202253|Secondary|Percentage of Participants With Creatinine Clearance at Least Twice the Baseline Value During Period of Drug Therapy||Baseline up to Day 28 post-treatment|Data was not analyzed as the study was retrospective and data for creatinine clearance was not available for the participants.|||||
827196|NCT01202253|Secondary|Percentage of Participants With Liver Function Test Results at Least Twice the Baseline Value During Period of Drug Therapy|Percentage of participants with liver function test results at least twice the baseline value during period of drug therapy was calculated for the liver function variables, bilirubin, aspartate transaminase, alkaline phosphatase and gamma glutamyl transferase.|Baseline up to Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria.||percentage of participants||95% Confidence Interval|Number
827197|NCT01202253|Secondary|Percentage of Participants With Abnormal Results for Liver Function at End of Drug Therapy|Percentage of participants with abnormal liver function results were based on 4 liver function variables- bilirubin, aspartate transaminase, alkaline phosphatase and gamma glutamyl transferase. Normal reference ranges of these variables are: plasma bilirubin: 3-17 micromoles/L or 2.5-10 mg/L for adults; aspartate transaminase: 6-34 IU/L for females and 8-40 IU/L for males; alkaline phosphatase: 5-38 IU/L for females and 10-50 IU/L for males; gamma glutamyl transferase: 7-32 IU/L for females and 11-50 IU/L for males.|Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria.||percentage of participants||95% Confidence Interval|Number
827198|NCT01202253|Secondary|Percentage of Participants With Abnormal Results for Liver Function at Initiation of Drug Therapy|Percentage of participants with abnormal liver function results were based on 4 liver function variables- bilirubin, aspartate transaminase, alkaline phosphatase and gamma glutamyl transferase. Normal reference ranges of these variables are: plasma bilirubin: 3-17 micromoles/L or 2.5-10 mg/L for adults; aspartate transaminase: 6-34 International Units/Liter (IU/L) for females and 8-40 IU/L for males; alkaline phosphatase: 5-38 IU/L for females and 10-50 IU/L for males; gamma glutamyl transferase: 7-32 IU/L for females and 11-50 IU/L for males. Upper limit of confidence interval was reported as 100 if the same was calculated as greater than 100 by standard calculations (outside the valid range of 0 to 100).|Baseline|Full analysis set included all participants who met the defined eligibility criteria.||percentage of participants||95% Confidence Interval|Number
827199|NCT01202253|Secondary|Percentage of Participants With Resolution of Signs of Infection According to Computerized Tomography (CT) Scan Results|A CT scan was performed and the resultant scan was reviewed for the presence of the infection as per investigator’s discretion.|Baseline up to Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria.||percentage of participants||95% Confidence Interval|Number
827200|NCT01202253|Secondary|Percentage of Participants With Resolution of Signs of Infection According to Ultrasound Scan Results|An ultrasound scan was performed and the resultant scan was reviewed for the presence of the infection as per investigator’s discretion.|Baseline up to Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria.||percentage of participants||95% Confidence Interval|Number
836868|NCT01301079|Primary|Pain 18 Hours|The scale measure pain after 18 hours (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10.|18 hours|||units on a scale||Standard Deviation|Mean
827203|NCT01202253|Secondary|Percentage of Participants Requiring Change or Additional Antifungal Therapy|Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 by standard calculations (outside the valid range of 0 to 100).|Baseline up to Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria.||percentage of participants||95% Confidence Interval|Number
827204|NCT01202253|Secondary|Percentage of Participants With Lack of Clinical Response|Favorable clinical response was defined as clinical resolution of signs and symptoms of infection and no need to change or add to antifungal therapy, or transition to oral antifungal to complete therapy.|Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.||percentage of participants||95% Confidence Interval|Number
827205|NCT01202253|Secondary|Percentage of Participants With Favorable Clinical Response|Favorable clinical response was defined as clinical resolution of signs and symptoms of infection and no need to change or add to antifungal therapy, or transition to oral antifungal to complete therapy.|Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.||percentage of participants||95% Confidence Interval|Number
827206|NCT01202253|Secondary|Percentage of Participants With Death Unrelated to Fungal Infection||Baseline up to Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria.||percentage of participants||95% Confidence Interval|Number
827207|NCT01202253|Secondary|Percentage of Participants With Death Attributable to Fungal Infection||Baseline up to Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria.||percentage of participants|||Number
827208|NCT01202253|Secondary|Percentage of Participants Who Died Due to All Causes|Death due to all causes included death attributable to fungal infection, death unrelated to fungal infection and death due to multiple causes.|Baseline up to Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria.||percentage of participants||95% Confidence Interval|Number
827209|NCT01202253|Secondary|Percentage of Participants With Unfavorable Outcome|Unfavorable outcome was defined as the need to change to another antifungal agent because of lack of clinical response or death due to the antifungal infection or microbiologic persistence of the fungus or superinfection with a new Candida, Aspergillus or other fungal strain occurring at least 3 days and up to 14 days of anidulafungin therapy, or a lack of follow up data about clinical and microbiologic responses at the end of anidulafungin therapy.|Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.||percentage of participants||95% Confidence Interval|Number
827210|NCT01202253|Primary|Percentage of Participants With Favorable Outcome|Favorable outcome was defined as favorable clinical response and documented or presumed microbial eradication (two negative follow-up blood cultures for bloodstream infections or a successful clinical response without follow-up cultures for other infections). Favorable clinical response was defined as clinical resolution of signs and symptoms of infection and no need to change or add to antifungal therapy, or transition to oral antifungal to complete therapy.|Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.||percentage of participants||95% Confidence Interval|Number
827211|NCT01202279|Primary|Change From Baseline in Total Symptom Score of the Wisconsin Upper Respiratory Symptom Survey - 21 (WURSS-21).|WURSS-21 is made up of 21 questions with a scoring from 0 = no symptom to 7 = severe symptom. With a minimum score of 0 to a maximum score of 147.|Baseline and 7 Days|||units on a scale||Standard Deviation|Mean
827212|NCT01202279|Primary|Antibiotic Sparing|Number of patients who received an antibiotic|Day 7|Per Protocol Population using Fishers Exact Test.||Participants|||Number
827213|NCT01202565|Secondary|Associations Between General Improvement in Psoriasis With Improvement in Quality of Life|Associations between general improvement in quality of life, measured by percentage change of DLQI, and general improvement in psoriasis at the same time, measured by percentage improvement of the PASI, were evaluated by means of Spearman’s rank correlation coefficient. Generally, correlation coefficients below 0.2 are considered as no or only weak association, between 0.2 and 0.5 as moderate association, between 0.5 and 0.8 as strong association and above 0.8 as very strong associations.|Baseline and Month 12|Full Analysis Set; participants with both PASI and DLQI data available. LOCF was used.||correlation coefficient|||Number
827214|NCT01202565|Secondary|Associations Between Improvement in Quality of Life With Improvement in Scalp Psoriasis|Associations between general improvement in quality of life, measured by percentage change of DLQI, and the improvement of scalp psoriasis at the same time, measured by percentage improvement of the PSSI, were evaluated by means of Spearman’s rank correlation coefficient. Generally, correlation coefficients below 0.2 are considered as no or only weak association, between 0.2 and 0.5 as moderate association, between 0.5 and 0.8 as strong association and above 0.8 as very strong associations.|Baseline and Month 12|Scalp Psoriasis Set; participants with both PSSI and DLQI data available. LOCF was used.||correlation coefficient|||Number
827215|NCT01202565|Secondary|Associations Between Improvement in Quality of Life With Improvement in Nail Psoriasis|Associations between general improvement in quality of life, measured by percentage change of DLQI, and the improvement of nail psoriasis at the same time, measured by percentage improvement of the NAPSI, were evaluated by means of Spearman’s rank correlation coefficient. Generally, correlation coefficients below 0.2 are considered as no or only weak association, between 0.2 and 0.5 as moderate association, between 0.5 and 0.8 as strong association and above 0.8 as very strong associations.|Baseline and Month 12|Nail Psoriasis Set; participants with both NAPSI and DLQI data available. LOCF was used.||correlation coefficient|||Number
827281|NCT01203852|Primary|Change in Blood Pressure From Baseline to Treatment|Response to blood pressure medication will be assessed by measuring blood pressure before and after treatment|after 6-8 weeks of treatment|All patients with antihypertensive response data. 282 patients completed all 3 study periods. 369 patients completed only period 1. 328 patients completed only period 3.||mmHg||Standard Deviation|Mean
836869|NCT01301079|Primary|Pain 12 Hours|The scale measure pain after 12 hours (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10.|12 hours|||units on a scale||Standard Deviation|Mean
827216|NCT01202565|Secondary|Associations Between General Improvement in Psoriasis With Improvement in Scalp Psoriasis|Associations between general improvement in psoriasis, measured by percentage change of PASI, and the improvement of scalp psoriasis at the same time, measured by percentage improvement of the PSSI, were evaluated by means of Spearman’s rank correlation coefficient. Generally, correlation coefficients below 0.2 are considered as no or only weak association, between 0.2 and 0.5 as moderate association, between 0.5 and 0.8 as strong association and above 0.8 as very strong associations.|Baseline and Month 12|Scalp Psoriasis Set; participants with both PSSI and PASI data available. LOCF was used.||correlation coefficient|||Number
827217|NCT01202565|Secondary|Associations Between General Improvement in Psoriasis With Improvement in Nail Psoriasis|Associations between general improvement in psoriasis, measured by percentage change of PASI, and the improvement of nail psoriasis at the same time, measured by percentage improvement of the NAPSI, were evaluated by means of Spearman’s rank correlation coefficient. Generally, correlation coefficients below 0.2 are considered as no or only weak association, between 0.2 and 0.5 as moderate association, between 0.5 and 0.8 as strong association and above 0.8 as very strong associations.|Baseline and Month 12|Nail Psoriasis Set; participants with both NAPSI and PASI data available. LOCF was used.||correlation coefficient|||Number
827218|NCT01202565|Secondary|Change From Baseline in DLQI Score|The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. A negative change from Baseline indicates improvement.|Baseline and Months 3, 6, 9, and 12|"Full Analysis Set with Baseline DLQI score; the analysis was based on all available data. Last observation carried forward (LOCF) was also used for the Month 12 time point. The number of participants included in the analysis at each time point is indicated by N."||units on a scale||Standard Deviation|Mean
827219|NCT01202565|Secondary|Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score|The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. Change from Baseline is presented as a percentage of the Baseline value: Month 12 value - Baseline value / Baseline value * 100. A negative change from Baseline indicates improvement.|Baseline and Month 12|Full analysis Set. Only participants with a Baseline and at least one post-baseline value are included. Last observation carried forward (LOCF) was used.||percent change||Standard Deviation|Mean
827220|NCT01202565|Secondary|Percentage of Participants Achieving a PASI 50 Response|"The percentage of participants with a ≥ 50% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline.
PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease."|Baseline and Months 3, 6, 9, and 12|"Full Analysis Set with Baseline PASI score; the analysis was based on all available data. Last observation carried forward (LOCF) was also used for the Month 12 time point. The number of participants included in the analysis at each time point is indicated by N."||percentage of participants|||Number
827221|NCT01202565|Secondary|Percentage of Participants Achieving a PASI 75 Response|"The percentage of participants with a ≥ 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline.
PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease."|Baseline and Months 3, 6, 9, and 12|"Full Analysis Set with Baseline PASI score; the analysis was based on all available data. Last observation carried forward (LOCF) was also used for the Month 12 time point. The number of participants included in the analysis at each time point is indicated by N."||percentage of participants|||Number
827222|NCT01202565|Secondary|Percentage of Participants Achieving a PASI 90 Response|"The percentage of participants with a ≥ 90% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline.
PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease."|Baseline and Months 3, 6, 9, and 12|"Full Analysis Set with Baseline PASI score; the analysis was based on all available data. Last observation carried forward (LOCF) was also used for the Month 12 time point. The number of participants included in the analysis at each time point is indicated by N."||percentage of participants|||Number
827223|NCT01202565|Secondary|Change From Baseline in PASI Score|The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. A negative change from Baseline indicates improvement.|Baseline and Months 3, 6, 9, and 12|"Full Analysis Set with Baseline PASI score; the analysis was based on all available data. Last observation carried forward (LOCF) was also used for the Month 12 time point. The number of participants included in the analysis at each time point is indicated by N."||units on a scale||Standard Deviation|Mean
827224|NCT01202565|Secondary|Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score|The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Change from Baseline is presented as a percentage of the Baseline value: Month 12 value - Baseline value / Baseline value * 100. A negative change from Baseline indicates improvement.|Baseline and Month 12|Full analysis Set. Only participants with a Baseline and at least one post-baseline value are included. Last observation carried forward (LOCF) was used.||percent change||Standard Deviation|Mean
827225|NCT01202565|Secondary|Percentage of Participants Achieving Complete Clearing of Scalp|Complete clearing on scalp is defined as a PSSI score of zero. The PSSI consists of two parts: an assessment of scalp area involved and an assessment of the 3 clinical symptoms erythema, induration and desquamation. Involved scalp area is measured on a scale from 0 (0% of scalp involved) to 6 (90-100% of scalp involved), clinical symptoms are each rated from 0 (absent) to 4 (severest possible). The composite score ranges from 0 (best) to 72 (worst) and is derived from the sum of symptom scores multiplied by the score of involved scalp area.|Months 3, 6, 9, and 12|"Scalp Psoriasis Set; the analysis was based on all available data. Last observation carried forward (LOCF) was also used for the Month 12 time point. The number of participants included in the analysis at each time point is indicated by N."||percentage of participants|||Number
827226|NCT01202565|Secondary|Percentage of Participants Achieving Good Clinical Response on Scalp|"Good clinical response on scalp is defined as a ≥ 50% improvement from Baseline in PSSI score.
The PSSI consists of two parts: an assessment of scalp area involved and an assessment of the 3 clinical symptoms erythema, induration and desquamation. Involved scalp area is measured on a scale from 0 (0% of scalp involved) to 6 (90-100% of scalp involved), clinical symptoms are each rated from 0 (absent) to 4 (severest possible). The composite score ranges from 0 (best) to 72 (worst) and is derived from the sum of symptom scores multiplied by the score of involved scalp area."|Baseline and Months 3, 6, 9, and 12|"Scalp Psoriasis Set; the analysis was based on all available data. Last observation carried forward (LOCF) was also used for the Month 12 time point. The number of participants included in the analysis at each time point is indicated by N."||percentage of participants|||Number
827227|NCT01202565|Secondary|Change From Baseline in Psoriasis Scalp Severity Index (PSSI)|The PSSI consists of two parts: an assessment of scalp area involved and an assessment of the 3 clinical symptoms erythema, induration and desquamation. Involved scalp area is measured on a scale from 0 (0% of scalp involved) to 6 (90-100% of scalp involved), clinical symptoms are each rated from 0 (absent) to 4 (severest possible). The composite score ranges from 0 (best) to 72 (worst) and is derived from the sum of symptom scores multiplied by the score of involved scalp area. A negative change from Baseline indicates improvement.|Baseline and Months 3, 6, 9, and 12|"Scalp Psoriasis Set; the analysis was based on all available data. Last observation carried forward (LOCF) was also used for the Month 12 time point. The number of participants included in the analysis at each time point is indicated by N."||units on a scale||Standard Deviation|Mean
827228|NCT01202565|Secondary|Percentage of Participants Achieving Complete Clearing of Nails|"Complete clearing of nails is defined as a total NAPSI score of zero.
The NAPSI grades nails for both nail matrix psoriasis and nail bed psoriasis. The sum of these two scores is the total score for that nail. Nail matrix psoriasis consists of any of the following: pitting, leukonychia, red spots in the lunula, or nail plate crumbling. Nail bed psoriasis is the presence or absence of onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration or nail bed hyperkeratosis. Scoring for each is based on the following scale:
0 = none;
1 = present in 1/4 nail quadrants;
2 = present in 2/4 nail quadrants;
3 = present in 3/4 nail quadrants;
4 = present in 4/4 nail quadrants.
The 2 most affected nails on either hands or feet were evaluated and summed for a score ranging from 0 (no nail psoriasis) to 16 (psoriasis in 4/4 nail quadrants)."|Months 3, 6, 9, and 12|"Nail Psoriasis Set; the analysis was based on all available data. Last observation carried forward (LOCF) was also used for the Month 12 time point. The number of participants included in the analysis at each time point is indicated by N."||percentage of participants|||Number
827229|NCT01202565|Secondary|Percentage of Participants Achieving a Good Clinical Response on Nail Psoriasis|"Good clinical response on nails is defined as ≥ 50% improvement from Baseline in total NAPSI score.
The NAPSI grades nails for both nail matrix psoriasis and nail bed psoriasis. The sum of these two scores is the total score for that nail. Nail matrix psoriasis consists of any of the following: pitting, leukonychia, red spots in the lunula, or nail plate crumbling. Nail bed psoriasis is the presence or absence of onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration or nail bed hyperkeratosis. Scoring for each is based on the following scale:
0 = none;
1 = present in 1/4 nail quadrants;
2 = present in 2/4 nail quadrants;
3 = present in 3/4 nail quadrants;
4 = present in 4/4 nail quadrants.
The 2 most affected nails on either hands or feet were evaluated and summed for a score ranging from 0 (no nail psoriasis) to 16 (psoriasis in 4/4 nail quadrants)."|Baseline and Months 3, 6, 9, and 12|"Nail Psoriasis Set; the analysis was based on all available data. Last observation carried forward (LOCF) was also used for the Month 12 time point. The number of participants included in the analysis at each time point is indicated by N."||percentage of participants|||Number
827230|NCT01202565|Secondary|Change From Baseline in Nail Psoriasis Severity Index (NAPSI)|"NAPSI grades nails for both nail matrix psoriasis and nail bed psoriasis. The sum of these two scores is the total score for that nail. Nail matrix psoriasis consists of any of the following: pitting, leukonychia, red spots in the lunula, or nail plate crumbling. Nail bed psoriasis is the presence or absence of onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration or nail bed hyperkeratosis. Scoring for each is based on the following scale:
0 = none;
1 = present in 1/4 nail quadrants;
2 = present in 2/4 nail quadrants;
3 = present in 3/4 nail quadrants;
4 = present in 4/4 nail quadrants.
The 2 most affected nails on either hands or feet were evaluated and summed for a score ranging from 0 (no nail psoriasis) to 16 (psoriasis in 4/4 nail quadrants).
A negative change from Baseline indicates improvement."|Baseline and Months 3, 6, 9, and 12|"Nail Psoriasis Set; the analysis was based on all available data. Last observation carried forward (LOCF) was also used for the Month 12 time point. The number of participants included in the analysis at each time point is indicated by N."||units on a scale||Standard Deviation|Mean
827231|NCT01202565|Primary|Percent Change From Baseline in Psoriasis Scalp Severity Index (PSSI) to Month 12|"The PSSI consists of two parts: an assessment of scalp area involved and an assessment of the 3 clinical symptoms erythema, induration and desquamation. Involved scalp area is measured on a scale from 0 (0% of scalp involved) to 6 (90-100% of scalp involved), clinical symptoms are each rated from 0 (absent) to 4 (severest possible). The composite score ranges from 0 (best) to 72 (worst) and is derived from the sum of symptom scores multiplied by the score of involved scalp area.
Change from Baseline is presented as a percentage of the Baseline value: Month 12 value - Baseline value / Baseline value * 100. A negative change from Baseline indicates improvement."|Baseline and Month 12|Scalp Psoriasis Set (SPS), which includes participants with a Baseline PSSI ≥ 10. Only participants with a Baseline and at least one post-baseline value are included. Last observation carried forward (LOCF) imputation was used.||percent change||Standard Deviation|Mean
827232|NCT01202565|Primary|Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) to Month 12|"NAPSI grades nails for both nail matrix psoriasis and nail bed psoriasis. The sum of these two scores is the total score for that nail. Nail matrix psoriasis consists of any of the following: pitting, leukonychia, red spots in the lunula, or nail plate crumbling. Nail bed psoriasis is the presence or absence of onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration or nail bed hyperkeratosis. Scoring for each is based on the following scale:
0 = none;
1 = present in 1/4 nail quadrants;
2 = present in 2/4 nail quadrants;
3 = present in 3/4 nail quadrants;
4 = present in 4/4 nail quadrants.
The 2 most affected nails on either hands or feet were evaluated and summed for a score ranging from 0 (no nail psoriasis) to 16 (psoriasis in 4/4 nail quadrants).
Change from Baseline is presented as a percentage of the Baseline value, calculated as: Month 12 value - Baseline value / Baseline value * 100. A negative change from Baseline indicates improvement."|Baseline and Month 12|Nail Psoriasis set, which includes participants with a Baseline NAPSI score ≥ 10. Only participants with a Baseline and at least one post-baseline value are included. Last observation carried forward (LOCF) imputation was used.||percent change||Standard Deviation|Mean
827233|NCT01202578|Secondary|Tube Retention|Presence of the tympanostomy tube across the tympanic membrane at the follow-up visit.|7 days|Tube retention was assessed for all TT successfully placed by the TTDS||percentage of tubes retained|Participants|95% Confidence Interval|Number
827234|NCT01202578|Secondary|Proportion of Subjects With Procedure Success|Procedure Success was defined as the successful placement of any tympanostomy tube in all enrolled ears in a given subject. Non-Acclarent tubes successfully placed manually following non-success of the TTDS were counted toward Procedure Success. Procedure Success was determined on a per subject basis: the rate was calculated by the number of subjects achieving Procedure Success out of the total number of enrolled subjects.|0 days|||percentage of participants||95% Confidence Interval|Number
827235|NCT01202578|Primary|Device Success|Device Success is defined as the successful delivery of the tympanostomy tube across the tympanic membrane using the tympanostomy tube delivery system (TTDS).Device Success is evaluated on a per device basis.|0 days|Device Success is evaluated on a per device basis.||percentage of devices|Participants|95% Confidence Interval|Number
827236|NCT01202578|Primary|Safety of Tympanostomy Tube (TT) Delivery System|Occurrence of pre-defined Safety Events of acoustic trauma, deployment of the TT into the middle ear, damage to middle ear structures, unintended tympanic membrane perforation requiring treatment, abrasion to the external acoustic meatus requiring significant treatment, and major bleeding requiring significant treatment.|7 days|Subjects in whom TTDS was attempted.||percentage of ears|Participants|95% Confidence Interval|Number
827237|NCT01202591|Primary|Safety and Tolerability in Terms of Number of Patients With Adverse Events (Serious and Non-serious)||3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).|All patients who receive at least one dose of study treatment (AZD4547 or exemestane)||Participants|||Number
827238|NCT01202643|Secondary|Implantation Rate|Number of gestational sacs per number of embryos transferred in each treatment group|28 days after embryo transfer|Presuming an implantation rate of 10% and anticipating a 10% increase to 20% with treatment, about 200 embryos transferred in each study arm would be needed for 80% power and alpha of 0.05.||Gestational sacs|Participants||Number
827239|NCT01202643|Primary|Endometrial Thickness|Thickness of the endometrium on the day of embryo transfer|Day of embryo transfer|||mm||Standard Deviation|Mean
827240|NCT01202656|Secondary|Live Birth Rates|Live birth rates among normal infertile couples undergoing IVF|Within nine months of embryo transfer|||Live Birth|||Number
827241|NCT01202656|Primary|Embryo Implantation and Clinical Pregnancy Rates|"Implantation rate: The number of gestational sacs noted in the endometrial cavity 26 to 30 days after embryo transfer divided by the number of embryos transferred
Clinical pregnancy:
Gestational sac with evidence of a viable pregnancy at least 28 days after embryo transfer"|26 to 30 days after embryo transfer|Presuming an implantation rate of 10% and anticipating a 10% increase to 20% with treatment, about 200 embryos transferred in each study arm would be needed for 80% power and alpha of 0.05.||Gestational sacs|Participants||Number
827242|NCT01202747|Primary|Association Between Screening Methods (Meibomian Gland Expression) and Treatment Effectiveness Outcomes (Total Meibomian Gland Score)|"Analysis of association between Baseline Meibomian Gland Expression Score and Total Meibomian Gland Score at 4 Weeks. Success was defined by demonstration of a statistically significant (p<0.05) association between the screening method and outcome.
Meibomian gland expression sum scores range from 0 to 60 with a higher score reflecting less meibomian gland dysfunction. Total meibomian gland scores range from 0 to 45 with a higher score reflecting less meibomian gland dysfunction."|Baseline and 4 Weeks|Results presented are for the Intent to Treat population.||Correlation coefficient|||Number
827243|NCT01202877|Primary|Overall Response (OR) Within 6 Months|Overall response defined as percentage of participants with response as follows: (OR = CR [complete response (CR) rate] + CRi [complete remission with incomplete count recovery] + PR [partial remission] + HI [hematologic improvement]) within 6 months of treatment initiation|6 Months|||percentage of participants|||Number
827292|NCT01203930|Secondary|Overall Survival|Overall survival (OS) is defined as the interval from the start of study treatment to death from any cause.|Up to 28 Months|Overall survival analysis was not performed because the follow-up period was insufficient to capture enough events.|||||
827966|NCT01205503|Secondary|Troponin Levels in Patients Receiving Doxorubicin Containing Chemotherapy|Continuous Measure of troponin at the 4 time points outlined in the protocol for each group.|prior to and 3 hours post doxorubicin and between cycles 1 and 2|||ng/ml||95% Confidence Interval|Geometric Mean
827244|NCT01202877|Primary|Participant Best Response Assessed Using Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1|Criteria for response per international working group for Myelodysplastic Syndrome (MDS) & acute myeloid leukemia (AML) where responders obtained a complete remission (CR), a CR with incomplete bone marrow recovery (CRi), a morphologic leukemia-free status (MLFS), or a partial remission (PR). CR: <5% bone marrow blasts, neutrophil count>1.0 X10⁹/L, & platelet count>100 X10⁹/L. CRi: all CR criteria except residual neutropenia (<1.0 X10⁹/L) or thrombocytopenia (<100 X10⁹/L). MLFS: <5% blasts in bone marrow regardless of neutrophil & platelet count in peripheral blood. PR: all CR criteria, except reduction> 50% in bone marrow blasts, but still >5%. Clinical responses evaluated using RECIST version 1.1 criteria after every two cycles, with confirmation of clinical response at 4 weeks after achieving response.|6 months|||participants|||Number
827245|NCT01202903|Secondary|Change From Baseline in Number of Puffs of Asthma Rescue Medication Following 24-week Treatment|Analysis of rescue medication use followed a similar method to that employed for total asthma symptom score. The mean number of puffs across the 28 days prior to the Week 24 assessment visit was used to calculate a change from baseline. LS Mean of change from baseline in mean number of puffs of asthma rescue medication is calculated with the ANCOVA model using treatment, stratification group, dosing schedule, gender, smoking status, center grouping, and baseline mean number of puffs of asthma rescue medication as covariates.|24 weeks|The FAS consisted of all randomized patients who received at least one dose of study drug. 7 randomized patients did not receive study drug and were excluded along with 1 other patient who did not receive study drug for more than 60 days||Number of puffs||Standard Error|Least Squares Mean
827246|NCT01202903|Secondary|Percentage of Participants With Investigator and Patient Global Evaluation of Treatment Effectiveness (GETE) at Weeks 16 and 24|The global evaluation of treatment effectiveness (GETE) is an assessment of asthma symptom control and overall response to asthma treatment. The evaluation was performed by both investigator and patient, each using the same 5 point scale. The GETE scale ranges were as follows: excellent, good, moderate, poor and worsening. A good or excellent response on the 5 point scale indicated that a patient had responded to treatment. 1=excellent 2=good 3=moderate 4=poor 5= worsening. Responder is defined as the patient who achieved an excellent or good response. Non-responder isdefined as the patient who achieved a moderate or poor or worsening response.|16 and 24 weeks|The FAS consisted of all randomized patients who received at least one dose of study drug. 7 randomized patients did not receive study drug and were excluded along with 1 other patient who did not receive study drug for more than 60 days||Percent|||Number
827247|NCT01202903|Secondary|Change From Baseline in Asthma Symptom Scores Following 24-week Treatment|Total asthma symptom score was derived for each day as the total of the morning (scale 0-1), daytime (scale 0-4) and nocturnal (scale 0-4) scores with a max score of 9. The mean score across the 28 days prior to the week 24 assessment visit was used to calculate a change from baseline. Analysis of total asthma symptom score was performed using ANCOVA model and Van-Elteren test. LS Mean of change from baseline in mean asthma symptom score is calculated with the ANCOVA model using treatment, stratification group, dosing schedule, gender, smoking status, center grouping, and baseline mean asthma symptom scores as covariates. Decrease of score on change from baseline means improvement of asthma symptom control.|24 weeks|The FAS consisted of all randomized patients who received at least one dose of study drug. 7 randomized patients did not receive study drug and were excluded along with 1 other patient who did not receive study drug for more than 60 days||Units on a scale||Standard Error|Least Squares Mean
827248|NCT01202903|Secondary|Percentage of Patients With at Least a 0.5 or 0.75 Point Improvement in the ACQ Score at Week 24|The Asthma Control Questionnaire (ACQ) is a questionnaire consisting of 7 questions assessing symptoms, airway caliber and rescue β2-agonist use. One value representing overall asthma control on that occasion was calculated. Decrease in scores of 0.5 or higher between ACQ assessments are considered clinically meaningful. The ACQ was completed by the patient at the Investigator’s site at Visit 2 (Week 1, pre-dose), Visit 6 (after completion of 16 weeks of treatment) and at the End of Study/Early Termination visit. Only patients with no more than 1 item missing are included, and the missing item was imputed by interpolation|24 weeks|The FAS consisted of all randomized patients who received at least one dose of study drug. 7 randomized patients did not receive study drug and were excluded along with 1 other patient who did not receive study drug for more than 60 days||Percent|||Number
827249|NCT01202903|Secondary|Change From Baseline in ACQ Score Following 24-week Treatment|The Asthma Control Questionnaire (ACQ) is a questionnaire consisting of 7 questions assessing symptoms, airway caliber and rescue β2-agonist use. One value representing overall asthma control on that occasion was calculated. Decrease in scores of 0.5 or higher between ACQ assessments are considered clinically meaningful. The ACQ was completed by the patient at the Investigator’s site at Visit 2 (Week 1, pre-dose), Visit 6 (after completion of 16 weeks of treatment) and at the End of Study/Early Termination visit. LS Mean of change from baseline in ACQ score is calculated with the ANCOVA model using treatment, stratification group, dosing schedule, center grouping, smoking status, and baseline ACQ score as covariates. Score 0= totally controlled, 6= extremely poorly controlled|24 weeks|The FAS consisted of all randomized patients who received at least one dose of study drug. 7 randomized patients did not receive study drug and were excluded along with 1 other patient who did not receive study drug for more than 60 days||Units on a scale||Standard Error|Least Squares Mean
827250|NCT01202903|Secondary|Percentage of Patients Achieving at Least a 0.5, 1.0 or 1.5 Point Improvement From Baseline in AQLQ Overall Score Following 24-week Treatment|The standardized version of the Asthma Quality of Life Questionnaire (AQLQs)), was used to assess the patients’ asthma-related quality of life. There are 32 questions in the AQLQ and they are in 4 domains (symptoms, activity limitation, emotional function and environmental exposure). Each question was answered on a 7 point scale (1-totally limited/problems all the time, 7-not at all limited/no problems). The overall AQLQ score is the mean of all 32 responses, and the individual domain scores are the means of the items in those domains (a minimum domain / overall score of 1 = Severely impaired whereas a maximum domain / overall score of 7 = not impaired at all). A positive change from baseline score indicates improvement.|24 weeks|The FAS consisted of all randomized patients who received at least one dose of study drug. 7 randomized patients did not receive study drug and were excluded along with 1 other patient who did not receive study drug for more than 60 days||Percent|||Number
828025|NCT01213706|Primary|Airway Blood Flow Response to Albuterol|Airway Blood Flow will be measured before and 15 minutes after the 180 mcg of albuterol inhalation.|Qaw post minus Qaw pre albuterol after WBPA or Sham WBPA|controls n =15, smokers N=15 , asthma N=15||μl/min/ml||Standard Error|Mean
827251|NCT01202903|Secondary|Change From Baseline in AQLQ Score Following 24-week Treatment|The standardized version of the Asthma Quality of Life Questionnaire (AQLQs)), was used to assess the patients’ asthma-related quality of life. There are 32 questions in the AQLQ and they are in 4 domains (symptoms, activity limitation, emotional function and environmental exposure). Each question was answered on a 7 point scale (1-totally limited/problems all the time, 7-not at all limited/no problems). The overall AQLQ score is the mean of all 32 responses, and the individual domain scores are the means of the items in those domains (a minimum domain / overall score of 1 = Severely impaired whereas a maximum domain / overall score of 7 = not impaired at all). A positive change from baseline score indicates improvement.|24 weeks|The FAS consisted of all randomized patients who received at least one dose of study drug. 7 randomized patients did not receive study drug and were excluded along with 1 other patient who did not receive study drug for more than 60 days||Units on a scale||Standard Error|Least Squares Mean
827252|NCT01202903|Secondary|Change From Baseline in % Predicted FEV1 Following 24-week Treatment|Spirometry was used at defined time points throughout the study to assess the clinical status of patients and to capture the following variables: forced expiratory volume in one second (FEV1), FEV1 percent predicted, forced vital capacity (FVC) and the FEV1/FVC ratio. During the Screening assessment, spirometry was performed pre- and post-bronchodilator administration to assess reversibility. During the treatment period (including prerandomization assessments on Day 1), spirometry was performed after withholding bronchodilators. The results of spirometry were required to meet the ATS/ERS criteria for acceptability and repeatability. Acceptability criteria were applied before repeatability was determined. LS Mean of change from baseline in % predicted FEV1 is calculated with the ANCOVA model using treatment, stratification group, dosing schedule, gender, center grouping, smoking status, and baseline % predicted FEV1 as covariates.|Baseline, 24 weeks|The FAS consisted of all randomized patients who received at least one dose of study drug. 7 randomized patients did not receive study drug and were excluded along with 1 other patient who did not receive study drug for more than 60 days||L/min||Standard Error|Least Squares Mean
827253|NCT01202903|Secondary|Change From Baseline in Mean Evening PEF (L/Min) Following 24-week Treatment|A Peak Expiratory Flow (PEF) meter was distributed to patients at Visit 1, to be used to measure PEF twice-daily as directed. During the Screening and Treatment Periods, PEF was measured in the morning and evening every day. the morning PEF was performed within 15 minutes after waking, and the evening PEF approximately 12 hours later. Patients were encouraged to perform morning and evening PEF measurements before the use of any LABA or rescue medication. The highest of 3 values was recorded as the daily personal best. The personal best was used to calculate the mean morning PEF and mean evening PEF value collected between assessment Visits. LS Mean of change from baseline in mean morning PEF is calculated with the ANCOVA model using treatment, stratification group, dosing schedule, gender, center grouping, smoking status, and baseline mean morning PEF as covariates.|Baseline, 24 weeks|The FAS consisted of all randomized patients who received at least one dose of study drug. 7 randomized patients did not receive study drug and were excluded along with 1 other patient who did not receive study drug for more than 60 days||L/min||Standard Error|Least Squares Mean
827254|NCT01202903|Primary|Change From Baseline in Mean Morning Peak Expiratory Flow (PEF) Following the 24-week Treatment Period|A Peak Expiratory Flow (PEF) meter was distributed to patients at Visit 1, to be used to measure PEF twice-daily as directed. During the Screening and Treatment Periods, PEF was measured in the morning and evening every day. the morning PEF was performed within 15 minutes after waking, and the evening PEF approximately 12 hours later. Patients were encouraged to perform morning and evening PEF measurements before the use of any LABA or rescue medication. The highest of 3 values was recorded as the daily personal best. The personal best was used to calculate the mean morning PEF and mean evening PEF value collected between assessment Visits LS Mean of change from baseline in mean morning PEF is calculated with the ANCOVA model using treatment, stratification group, dosing schedule, gender, center grouping, smoking status, and baseline mean morning PEF as covariates.|Baseline, 24 weeks|The FAS consisted of all randomized patients who received at least one dose of study drug. 7 randomized patients did not receive study drug and were excluded along with 1 other patient who did not receive study drug for more than 60 days||L/min||Standard Error|Least Squares Mean
827255|NCT01202955|Secondary|Correct Reaction Time During Attention Task Performance After Overnight Abstinence.|We wanted to examine the effects of Tolcapone on the Continuous Performance Task (attention task) after overnight abstinence as compared to placebo.|30 days|Only participants who completed both study phases were analyzed.||Milliseconds||Standard Deviation|Mean
827256|NCT01202955|Secondary|N-back (Working Memory) Correct Reaction Time After Overnight Abstinence.|To obtain preliminary data on the effects of Tolcapone on abstinence-induced neurocognitive deficits in abstinent smokers with differing COMT genotypes. We examined reaction time differences on the n-back task between tolcapone and placebo treatment.|30 days|Only participants who completed both sessions were analysed||Milliseconds||Standard Deviation|Mean
827257|NCT01202955|Primary|Number of Eligible Participants Enrolled Who Completed the Study.|Number of enrolled participants who complete the final study visit|30 days|Number of Participants who completed the study.||Participants|||Number
827258|NCT01203046|Primary|Other Complications|Patients with complications different to surgical site infection.|10 days|Patients who presented any complication different of surgical site infection after surgery||participants|||Number
827259|NCT01203046|Primary|Surgical Site Infection|The patients were evaluated up to 10 days with close observation of surgical site. We concluded as surgical site infection when inflammatory signs, purulent discharge, intestinal liquid and aponeurosis disruption was observed.|10 days|All patients with inflammatory signs, purulent discharge, intestinal liquid and aponeurosis disruption observed at surgical site were included.||participants|||Number
827260|NCT01203072|Secondary|Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding|Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding. Related to the study drug|2 weeks|Safety Analysis Set is defined as subjects secondarily enrolled in study, but excluded those with significant GCP violations, did not receive any doses of study drug, or had no safety data after start of study treatment. Subjects with significant GCP violations, but received at least one dose of study drug, safety data were assessed individually||percentage of subjects with bleeds||95% Confidence Interval|Number
828177|NCT01214980|Secondary|Numeric Itching Score|Average donor site itching score for treatment group, numeric scale 0 (no itch) to 10 (worst possible itch), at 5 weeks post skin graft procedure|5 weeks|Randomized subjects with a minimum of 4 out of 5 study treatments and itching score reported||units on a scale||Standard Error|Mean
827261|NCT01203072|Primary|Proportion of Subjects With Venous Thromboembolism Events.|"The primary efficacy endpoint was the proportion of subjects who experienced at least one of the thromboembolic events listed below during the period from the start of study treatment to the venography at the end of study treatment.
Lower extremity DVT confirmed by bilateral venography at the end of study treatment
Definite diagnosis of symptomatic PE
Symptomatic DVT confirmed before the venography at the end of study treatment The objectives were to verify the non-inferiority of edoxaban to enoxaparin with regard to prevention of VTE"|2 weeks|The FAS was defined as all subjects enrolled in the study, but excluded those who had significant GCP violations, who had not received any doses of the study drug, or those who did not develop symptomatic DVT or PE, but in whom venography was not appropriately performed.||percentage of participants||95% Confidence Interval|Number
827262|NCT01203098|Secondary|Incidence of Major Bleeding or Clinically Relevant Non-major Bleedings.||2 weeks|The Safety Analysis Set was defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment||percentage of subjects with bleeds||95% Confidence Interval|Number
827263|NCT01203098|Primary|Percentage of Subjects With Venous Thromboembolism Events|"The primary efficacy endpoint was the proportion of subjects who experienced at least one of the thromboembolic events listed below during the period from the start of study treatment to the venography at the end of study treatment.
Lower extremity DVT confirmed by bilateral venography at the end of study treatment
Definite diagnosis of symptomatic PE
Symptomatic DVT confirmed before the venography at the end of study treatment The objectives were to verify the non-inferiority of edoxaban to enoxaparin with regard to prevention of VTE"|2 weeks|The FAS was defined as all subjects enrolled in the study, but excluded those who had significant GCP violations, who had not received any doses of the study drug, or those who did not develop symptomatic DVT or PE, but in whom venography was not appropriately performed.||percent of participants with VTE event||95% Confidence Interval|Number
827264|NCT01203319|Secondary|the Safety of Recombinant Hepatitis B Vaccines in Nonresponders|assessment of the local and systemic adverse reaction within the first 30 days after third vaccination|within the first 30 days after third vaccination||||||
827265|NCT01203319|Secondary|the Safety of Recombinant Hepatitis B Vaccines in Nonresponders|assessment of the local and systemic adverse reaction within the first 30 days after second vaccination|within the first 30 days after second vaccination||||||
827266|NCT01203319|Secondary|the Safety of Recombinant Hepatitis B Vaccines in Nonresponders|assessment of the local and systemic adverse reaction within the first 30 days after first vaccination|within the first 30 days after first vaccination||||||
827267|NCT01203319|Secondary|Immunogenicity of Recombinant Hepatitis B Vaccines in Nonresponders|Quantitative detection of anti-HBs using ratio-immunity method on serum obtained one month after first vaccination|one month after the first vaccination|||participants|||Number
827268|NCT01203319|Primary|Immunogenicity of Recombinant Hepatitis B Vaccines in Nonresponders|Quantitative detection of anti-HBs using ratio-immunity method on serum obtained one month after third vaccination|one month after the third vaccination|||participants|||Number
827269|NCT01203319|Primary|Immunogenicity of Recombinant Hepatitis B Vaccines in Nonresponders|Quantitative detection of anti-HBs using ratio-immunity method on serum obtained one month after second vaccination|one month after the second vaccination|Accroding to Protocol set||participants|||Number
827270|NCT01203644|Secondary|Adverse Events|Safety assessments included monitoring of treatment-emergent adverse events|Through 30 days postdose||||||
827271|NCT01203644|Primary|Time to First Use of Supplemental Pain Medication|The primary efficacy endpoint was the time to first use of supplemental pain medication (opioid or non-opioid) postoperatively for surgical wound pain|Through 96 hours postdose|||hours||Inter-Quartile Range|Median
827272|NCT01203787|Secondary|Number of Subjects With Dose Reductions||11/22/2010-3/10/2014|||participants|||Number
827273|NCT01203787|Secondary|Number of Subjects With Dose Interruptions||Baseline-End of Treatment (11/22/2010-3/10/2014)|||participants|||Number
827274|NCT01203787|Primary|Cumulative Dose of Sorafenib|Table below shows mean cumulative dose of sorafenib for each of the dosing regimens.|11/22/2010-1/27/14|||mg||Standard Deviation|Mean
827275|NCT01203787|Secondary|Frequency and Severity of Adverse Events According to National Cancer Institute- CTCAE|The total number of CTCAE (Common Terminology Criteria) grade 5 adverse events was collected for each dosing regimen beginning at baseline through 6 months of treatment.|11/22/2010-3/10/2014|||Grade 5 Adverse Events|||Number
827276|NCT01203787|Secondary|Safety of Dosing Regimens as Assessed by the Frequency and Severity of Adverse Events According to National Cancer Institute- CTCAE|The total number of CTCAE (Common Terminology Criteria) grade 4 adverse events was collected for each dosing regimen beginning at baseline until Week 24/Early Termination Visit.|11/22/2010-3/10/2014|||Grade 4 adverse events|||Number
827277|NCT01203787|Secondary|Safety and Efficacy of Sorafenib Dosing Regimens|Safety of Sorafenib was assessed by the frequency and severity of adverse events according to NCI-CTCAE grading|Baseline-End of Treatment (11/22/2010-3/10/2014)|The total number of CTCAE (Common Terminology Criteria) grade 3 adverse events was collected for each dosing regimen||Grade 3 adverse events|||Number
827278|NCT01203787|Primary|Total (Cumulative) Dose Delivery of Sorafenib|This outcome measure table shows the median cumulative dose delivered to the subjects randomized to the standard dosing regimen (N=63) and ramp-up regimen (N=57) at 4 months of treatment.|4 months-1/12/2010-1/27/14|||mg||Full Range|Median
827279|NCT01203826|Primary|Skeletal Radiograph Evaluation Using a Qualitative Radiographic Global Impression of Change (RGI-C) Scale Compared to Baseline (Pre-treatment) in Study ENB-006-09.|"Evaluation of radiographic change in rickets severity (as assessed by skeletal radiographs of the hands/wrists and knees) from the Baseline of Study ENB-006-09 relative to the End of Study (EOS) visit in Study ENB-008-10 using an ordinal RGI-C scale score. The RGI-C is a 7-point rating scale that ranges from -3 (indicative of severe worsening of HPP associated rickets) to +3 (indicative of complete or near complete healing of HPP associated rickets).
The time points will be pre-treatment (Baseline from Study ENB-006-09) to the last radiographic assessment in Study ENB-008-10, which represents at least 72 months of treatment."|At least 72 months of treatment with asfotase alfa|Each visit in Study ENB-008-10 was calculated relative to the start of exposure to asfotase alfa in Study ENB-006-09 (24 weeks are added to each visit in Study ENB-008-10). Results shown are for the last assessment in Study ENB-008-10 and represent at least 72 months of treatment with asfotase alfa.||units on a scale||Full Range|Median
827282|NCT01203878|Secondary|Cosmetic Appearance|"Change (improvement) in investigator scores of cosmetic appearance of the treatment area (entire face) by objective and subjective assessments:
INVESTIGATOR COSMETIC ASSESSMENT 0 - Facial skin is smooth to the touch, without significant lines or unevenness in pigmentation
1 - Facial skin shows 1 area (cheeks, forehead, or the perioral area) of significant 3 - Facial skin shows 3 areas with significant roughness, dyspigmentation, or fine lines 2 - Facial skin shows 2 areas of significant roughness, dyspigmentation, or fine lines 4 - All are severe in severity"|Week 18 (4 weeks after randomization visit)|Randomized patients with both a baseline and a week 18 investigator cosmetic appearance score. One imiquimod/observation patient did not have an end of study investigator cosmetic appearance score.||units on a scale||Standard Deviation|Mean
827283|NCT01203878|Secondary|Complete Clearance|The proportion of randomized patients with complete clearance of actinic keratoses in the treatment area (entire face).|Week 18 (4 weeks after randomization visit)|Randomized patients with a week 18 actinic keratosis count.||participants|||Number
827284|NCT01203878|Primary|Actinic Keratosis Count|The percent change in actinic keratosis count as compared to the baseline lesion count|Week 18 (4 weeks after randomization visit)|Randomized patients with both a baseline and a week 18 actinic keratosis count. One patient in imiquimod/observation group did not have a baseline count and therefore was not included in the analysis.||percent reduction in baseline count||Standard Deviation|Mean
827285|NCT01203917|Secondary|Overall Survival (OS)|OS was defined as the time from first dose of gefitinib study treatment until death by any cause. Patients who had not died at the time of analysis were censored at the last date the patient was known to be alive.|Survival follow up from first dose of gefitinib till death of the patient or till end of study in absence of death.|Full analysis set, EGFR M+ patients who had taken at least 1 dose of gefitinib||Months||95% Confidence Interval|Median
827286|NCT01203917|Other Pre-specified|Progression - Free Survival (PFS) (Independent Central Review)|PFS was defined as the time from the first dose of gefitinib study treatment until objective disease progression as defined by RECIST 1.1 (≥20% increase in the sum of the diameters of target lesions from minimum, clinically significant progression in non-target lesions or the presence of a new lesion) or death (by any cause in the absence of progression). Progression is based on measurements of scans by central review.|Scans taken at baseline and then follow up assessments taken every 6 weeks until progression, or last evaluable assessment in the absence of progression, assessed up to 23 months|Full analysis set, EGFR M+ patients who had taken at least 1 dose of gefitinib||Months||95% Confidence Interval|Median
827287|NCT01203917|Secondary|Progression - Free Survival (PFS) (Investigator)|PFS was defined as the time from the first dose of gefitinib study treatment until objective disease progression as defined by RECIST 1.1 (≥20% increase in the sum of the diameters of target lesions from minimum, clinically significant progression in non-target lesions or the presence of a new lesion) or death (by any cause in the absence of progression). Progression is based on measurements made at site by investigator.|Scans taken at baseline and then follow up assessments taken every 6 weeks until progression, or last evaluable assessment in the absence of progression, assessed up to 23 months|Full analysis set, EGFR M+ patients who had taken at least 1 dose of gefitinib||Months||95% Confidence Interval|Median
827288|NCT01203917|Other Pre-specified|Objective Response Rate (ORR) (Independent Central Review))|% of patients in the Full analysis set who have a complete response [CR] or partial response [PR] confirmed by repeat imaging at least 4 weeks later with no evidence of progression between confirmation visits (as defined by Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1)). CR: disappearance of all target lesions (TLs) & non-target lesions (NTLs). PR: >= 30% decrease in the sum of diameters compared to baseline (with no evidence of progression) and the NTLs are at least stable with no evidence of new lesions. Outcome is based on measurements of scans by central review.|Scans taken at baseline and then follow up assessments taken every 6 weeks until progression, or last evaluable assessment in the absence of progression, assessed up to 23 months|Full analysis set, EGFR M+ patients who had taken at least 1 dose of gefitinib||Percentage of Participants|||Number
827289|NCT01203917|Other Pre-specified|Disease Control Rate (DCR) (Independent Central Review)|DCR is calculated as the % of the FAS patient population with a best visit response of CR, PR (a visit response of CR or PR which is confirmed at least 4 weeks later) or stable disease (SD). SD is defined as no evidence of CR, PR or progression and must have occurred at a minimum of 6 weeks after first dose of study treatment. (progression is defined as ≥20% increase in the sum of the diameters of target lesions from minimum; clinically significant progression in non-target lesions; the presence of a new lesion or death). Outcome is based on measurements of scans by central review.|Scans taken at baseline and then follow up assessments taken every 6 weeks until progression, or last evaluable assessment in the absence of progression, assessed up to 23 months|Full analysis set, EGFR M+ patients who had taken at least 1 dose of gefitinib||Percentage of Participants|||Number
827290|NCT01203917|Secondary|Disease Control Rate (DCR) (Investigator)|DCR is calculated as the % of the FAS patient population with a best visit response of CR, PR (a visit response of CR or PR which is confirmed at least 4 weeks later) or stable disease (SD). SD is defined as no evidence of CR, PR or progression and must have occurred at a minimum of 6 weeks after first dose of study treatment. (progression is defined as ≥20% increase in the sum of the diameters of target lesions from minimum; clinically significant progression in non-target lesions; the presence of a new lesion or death). Outcome is based on measurements made at site by investigator.|Scans taken at baseline and then follow up assessments taken every 6 weeks until progression, or last evaluable assessment in the absence of progression, assessed up to 23 months|Full analysis set, EGFR M+ patients who had taken at least 1 dose of gefitinib||Percentage of Participants|||Number
827291|NCT01203917|Primary|Objective Response Rate (ORR) (Investigator)|% of patients in the Full analysis set who have a complete response [CR] or partial response [PR] confirmed by repeat imaging at least 4 weeks later with no evidence of progression between confirmation visits (as defined by Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1)). CR: disappearance of all target lesions (TLs) & non-target lesions (NTLs). PR: >= 30% decrease in the sum of diameters compared to baseline (with no evidence of progression) and the NTLs are at least stable with no evidence of new lesions. Outcome is based on measurements made at site by investigator.|Scans taken at baseline and then follow up assessments taken every 6 weeks until progression, or last evaluable assessment in the absence of progression, assessed up to 23 months|Full analysis set, EGFR M+ patients who had taken at least 1 dose of gefitinib||Percentage of Participants|||Number
827293|NCT01203930|Secondary|Changes in Potential Pharmacodynamic Markers of Drug Activity in Plasma and Whole Blood|"Changes in potential pharmacodynamic markers of drug activity will include assessments of chemokine and cytokine concentrations, effects on the activity of PI3K and related pathways, and effect on cell migration and other functional outcomes. This endpoint will be assessed at the following time points:
Idelalisib+Rituximab (Cohort 1): Predose and 1.5 hour postdose on Day 1 and predose on Days 15, 29, 57, 113, and 169
Idelalisib (Cohort 2): Predose on Days 1, 29, 57, 141"|Up to 169 days|The collection of plasma samples for pharmacodynamic (PD) analysis in this study was planned prior to the availability of results from an identical PD analysis in another idelalisib study with a larger sample size (n = 176 unique subjects with 2085 longitudinal plasma samples). Therefore, PD analysis was not performed in this study (n = 41).|||||
827294|NCT01203930|Secondary|Idelalisib Plasma Concentrations (Cohort 2)||Predose and 1.5 hours postdose at Weeks 0 and 4 and predose at Weeks 8 and 20|PK Analysis Set: participants in the ITT Analysis Set from Cohort 2 who had the necessary baseline and on-study measurements to provide interpretable results for the specific parameters of interest.||ng/mL||Inter-Quartile Range|Median
827295|NCT01203930|Secondary|Idelalisib Plasma Concentrations (Cohort 1)||Predose and 1.5 hours postdose at Weeks 0, 4, and 24|Pharmacokinetic (PK) Analysis Set: participants in the ITT Analysis Set from Cohort 1 who had the necessary baseline and on-study measurements to provide interpretable results for the specific parameters of interest.||ng/mL||Inter-Quartile Range|Median
827296|NCT01203930|Secondary|Progression-Free Survival|"Progression-free survival (PFS) was defined as the interval from the first dose date of drug to the earlier of the first documentation of definitive disease progression or death from any cause.
Progression was defined using the Standardized IWCLL criteria as specifically modified for this study to consider the mechanism of action of idelalisib and similar drugs. The occurrence of any of the following events indicated progression:
Evidence of any new disease
Evidence of worsening of index lesions, spleen or liver, or non-index disease
Decrease in platelet count or hemoglobin that is attributable to CLL and is confirmed by bone marrow biopsy"|Up to 28 Months|ITT Analysis Set||months||95% Confidence Interval|Median
827297|NCT01203930|Secondary|Duration of Response|Duration of response (DOR) was defined as the interval from the first documentation of CR or PR to the earlier of the first documentation of disease progression or death from any cause.|Up to 28 Months|Participants in the ITT Analysis Set who achieved complete or partial response.||months||95% Confidence Interval|Median
827298|NCT01203930|Secondary|Percent Change From Baseline in the Sum of the Product of the Greatest Perpendicular Diameters (SPD) of All Measurable Lesions||Baseline; Weeks 8, 16, 24, 36, 48, 60, 72, 84, 96, 108, and 120|Participants in the ITT Analysis Set with available data were analyzed.||percent change||Full Range|Median
827299|NCT01203930|Secondary|Lymphadenopathy Response Rate|Lymphadenopathy response rate was defined as the percentage of participants with a ≥ 50% reduction from baseline in the sum of the perpendicular diameters of all measurable lesions while receiving study therapy.|Baseline and up to 28 Months|Participants in the ITT Analysis Set with baseline measurable lymph nodes were analyzed.||percentage of participants||95% Confidence Interval|Number
827300|NCT01203930|Secondary|Overall Safety of Idelalisib|The overall safety of idelalisib was assessed as the percentage of participants experiencing treatment-emergent adverse events (AEs; Serious AEs, Grade ≥ 3 AEs, AEs related to idelalisib, and AEs leading to discontinuation of idelalisib).|Up to 28 Months|ITT Analysis Set||percentage of participants|||Number
827301|NCT01203930|Primary|Overall Response Rate (ORR)|"ORR was assessed based on standardized International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria as specifically modified for this study to reflect current recommendations which consider the mechanism of action of idelalisib and similar drugs, and was defined as the proportion of participants achieving a complete response (CR) or partial response (PR) as assessed by the investigator. Based on the CLL response definition in the protocol (modified Hallek 2008), the parameters of lymphadenopathy, liver and/or spleen size, constitutional symptoms, polymorphonuclear leukocytes, circulating clonal B-lymphocytes, platelet count, hemoglobin, and marrow were assessed.
CR: meeting all defined criteria
PR: meeting at least 2 of the criteria of circulating lymphocytes, lymphadenopathy, liver, spleen, or bone marrow (or only lymphadenopathy if liver and spleen normal at baseline) and at least 1 of the criteria for polymorphonuclear leukocytes, platelet count, or hemoglobin."|Up to 28 Months|Intent-to-treat (ITT) Analysis Set: participants who received at least 1 dose of idelalisib.||percentage of participants||95% Confidence Interval|Number
827302|NCT01197326|Secondary|Respiration Rate Impact on RRT Calls|Proportion of calls secondary to abnormal respiratory vital signs. Respiration Rate is considered to be one of the main early indicators of deterioration.|6 months|||percentage of calls|||Number
827303|NCT01197326|Primary|Survival|Survival at the end of the RRT call (time when the RRT team left the patient, average duration of calls around 25 min)|6 months|||percentage of participants|||Number
827304|NCT01197417|Secondary|Hospital Length of Stay||Start of first study drug infusion to actual hospital discharge|||Hours||Inter-Quartile Range|Median
827305|NCT01197417|Secondary|Development of Acute Chest Syndrome (ACS)||Patients will be monitored daily, on average, during their length of stay until discharge, up to 10 days post enrollment|||Paricipants|||Number
827306|NCT01197417|Secondary|Rehospitalization||Rehospitalization will be measured at 7 days post discharge and at the follow-up visit (on average, 30 days post discharge)|All participants who received at least one dose of study drug who had known rehospitalization status within 7 days||Participant|||Number
827307|NCT01197417|Secondary|Warm Sensation Associated With Study Drug Infusion|Patient spontaneously reported feelings of warmth during any study drug infusion.|Patient-reported warm sensation upon infusion will be monitored every 8 hours, concurrent with each infusion, and for 20-30 minutes after infusion completion, until discharge, up to 2 days post enrollment|All participants who received at least one dose of study drug.||Participant|||Number
827308|NCT01197417|Secondary|Hypotension Associated With Infusion|For each study drug infusion, systolic blood pressure (SBP) was measured just prior to the start of the infusion and again every 10 minutes until 30 minutes until the end of the infusion. Hypotension was defined as a greater than 20% reduction in SBP relative to corresponding baseline measurement for any study drug infusion.|Blood pressure will be monitored every 8 hours, concurrent with each infusion, and for 20-30 minutes after infusion completion, until discharge, up to 2 days post enrollment|All participants who received at least one dose of study drug||Participant|||Number
827309|NCT01197417|Secondary|Number of Morphine Equivalents Per Kilogram of Body Weight Used During Hospitalization||Total morphine equivalents used during the hospitalization will be recorded on the day of discharge, up to 10 days post enrollment|All participants who received at least one dose of study drug and who did not withdraw from data collection prior to either hospital discharge or 12 hours after last intravenous opioid.||mg Morphine/kg||Inter-Quartile Range|Median
827310|NCT01197417|Primary|Hospital Length of Stay (Hours)||From the time of the start of first study med infusion until hospital discharge or 12 hours after the last IV opioid, whichever occurs first, up to 10 days post enrollment|All participants who received at least one dose of study drug and who did not withdraw from data collection prior to outcome||hours||Inter-Quartile Range|Median
827311|NCT01197495|Secondary|Duration Effect of Treatment on Lip Fullness|Duration of treatment effect on lip fullness is assessed by the blinded Evaluating Investigator as ≥1-point Improvement from baseline in overall lip fullness of the eligible lip at each visit.|Month 1, Month 3, Month 6, Month 7.5, Month 9, Month 10.5, Month 12|Modified Intent-to-Treat: all treated subjects with data at the designated time point||% of Pts Retaining ≥1-point Improvement||95% Confidence Interval|Number
827312|NCT01197495|Secondary|Percentage of Subjects Achieving Their Personal Treatment Goal of Overall Lip Fullness|Subjects assessed their personal treatment goal of overall lip fullness as 'achieved' or 'not achieved.'|Baseline, Month 3|Treated subjects in the Treatment group||Percentage of Subjects|||Number
827313|NCT01197495|Secondary|Percentage of Oral Commissures With ≥1-Point Improvement on the Oral Commissures Severity (OCS) Scale|Subject's right and left oral commissures are assessed compared to baseline using the validated OCS Scale. Scores range from 0=none (best) to 3=severe (worst).|Baseline, Month 3|Subjects treated for OCS at the designated time points||Percentage of Oral Commissures|Participants||Number
827314|NCT01197495|Secondary|Percentage of Subjects With ≥1-Point Improvement on the Perioral Line (POL) Severity Scale|Subject's upper lip perioral lines are assessed compared to baseline using the 4-point validated POL Severity Scale. Scores range from 0=None (best) to 3=Severe (worst).|Baseline, Month 3|Subjects treated for POL at the designated time points||Percentage of Subjects|||Number
827315|NCT01197495|Primary|Percentage of Subjects With ≥1-Point Improvement on the Investigator Assessed 5-point Lip Fullness Scale 2 (LFS2)|Overall lip fullness is assessed by the blinded Evaluating Investigator compared to baseline using the 5-point LFS2. Scores range from 1=minimal improvement to 5=very marked improvement.|Baseline, Month 3|Modified Intent-to-Treat: all treated subjects with data at the designated time point||Percentage of Subjects||95% Confidence Interval|Number
827316|NCT01197508|Secondary|Change in EuroQol - 5 Dimensions (EQ-5D) From Randomization (Week 8) to End of Treatment (Week 16)|A self-assessment questionnaire that provides 2 measures of health status. The EQ-5D index score is a weighted linear combination over 5 dimensions of health status. The score for each of the 5 dimensions can range from 1 to 3, and an equation is used to calculate the EQ-5D index score. The EQ-5D index score can range from possible negative values to a maximum of 1.0. The EQ-VAS is a visual analog scale with a range of 0 to 100. For both variables, a higher score indicates a better health state.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
827317|NCT01197508|Secondary|Change From Randomization (Week 8) to End of Treatment (Week 16) in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q LES-Q-SF) Item 16|The Q-LES-Q-SF (Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form) measures the patient’s satisfaction with medication and overall quality of life. The 16th item is a global rating of overall life satisfaction and contentment. Higher scores are indicative of greater enjoyment or satisfaction in each domain.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
827318|NCT01197508|Secondary|Change From Randomization (Week 8) to End of Treatment (Week 16) in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q LES-Q-SF) Item 15|The Q-LES-Q-SF (Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form) measures the patient’s satisfaction with medication and overall quality of life. The 15th item queries respondents’ satisfaction with the medication they are taking. Higher scores are indicative of greater enjoyment or satisfaction in each domain.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
827319|NCT01197508|Secondary|Change in Overall Quality of Life and Satisfaction From Randomization (Week 8) to End of Treatment (Week 16) by Assessing the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) % Maximum Total Score|The Q-LES-Q-SF (Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form) total score is derived by summing item scores 1 to 14. Higher scores are indicative of greater enjoyment or satisfaction in each domain. The Q-LES-Q-SF % maximum total score is calculated as 100% × (Q-LES-Q-SF total score – 14) / 56, and can range from 0% to 100%.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
827320|NCT01197508|Secondary|Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Family Life/Home Responsibilities Domain Score|A 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The 3 inter-correlated domains are school/work, social life, and family life/home responsibilities. The numerical rating for the SDS family life/home responsibilities domain score is 0- 10, where 10 is considered to be 'highly impaired'.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
828223|NCT01215279|Secondary|Serum Amyloid-A (SAA) Concentration in Plasma at Baseline|Baseline = Day 1 = Visit 2|Day 1|||ng/mL||Full Range|Geometric Mean
827321|NCT01197508|Secondary|Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Social Life Domain Score|A 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The 3 inter-correlated domains are school/work, social life, and family life/home responsibilities. The numerical rating for the SDS social life domain score is 0- 10, where 10 is considered to be 'highly impaired'.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
827322|NCT01197508|Secondary|Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Work/School Domain Score|A 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The 3 inter-correlated domains are school/work, social life, and family life/home responsibilities. The numerical rating for the work/school domain score is 0- 10, where 10 is considered to be 'highly impaired'.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
827323|NCT01197508|Secondary|Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by the Sheehan Disability Scale (SDS) Total Score|Sheehan Disability Scale (SDS) is 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The SDS total score is calculated as the sum of the score for the 3 inter-correlated domains (school/work, social life, and family life/home responsibilities) and ranges from 0 (unimpaired) to 30 (highly impaired).|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
827324|NCT01197508|Secondary|Change in MADRS Total Score From Randomization (Week 8) to Week 14|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to Week 14|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
827325|NCT01197508|Secondary|Change in MADRS Total Score From Randomization (Week 8) to Week 12|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to Week 12|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
827326|NCT01197508|Secondary|Change in MADRS Total Score From Randomization (Week 8) to Week 10|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to Week 10|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
827327|NCT01197508|Secondary|Change in MADRS Total Score From Randomization (Week 8) to Week 9|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to Week 9|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
827328|NCT01197508|Secondary|Change in Hamilton Anxiety Scale (HAM-A) Total Score From Randomization (Week 8) to End of Treatment (Week 16)|A 14-item clinician-administered scale for the evaluation of anxiety symptoms. Each HAM-A item is rated on a 0 to 4 scale. Higher HAM-A scores indicate higher levels of anxiety.|Randomization (Week 8) to end of treatment (Week 16)|||units on a scale||Standard Error|Least Squares Mean
827329|NCT01197508|Secondary|Response in the Clinical Global Impression-Improvement (CGI-I) Defined as CGI-I Rating of “Very Much Improved” or “Much Improved” From Randomization (Week 8) to End of Treatment (Week 16)|A 3-part, clinician-administered scale that rates the improvement or worsening of the patient’s illness from randomization (baseline). Each item is scored on a 1 to 7 scale. CGI-I scores >4 indicate worsening, while scores <4 indicate improvement.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||percentage of participants analyzed|||Number
827330|NCT01197508|Secondary|Change in the Clinician-rated Global Outcome of Severity as Measured by the Clinical Global Impression-Severity (CGI-S) Score From Randomization (Week 8) to End of Treatment (Week 16)|A 3-part, clinician-administered scale that rates the improvement or worsening of the patient’s illness from randomization (baseline). Each item is scored on a 1 to 7 scale. Higher CGI-S scores indicate greater illness severity.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
828224|NCT01215279|Secondary|CCL2 Concentration in Plasma at End of Treatment|End of treatment = 4 weeks = Visit 6|week 4|||pg/mL||Full Range|Geometric Mean
827331|NCT01197508|Secondary|Change in Depressive Symptoms From Randomization (Week 8) to End of Treatment (Week 16) as Measured by Hamilton Rating Scale for Depression-17 Items (HAMD-17) Total Score|A 17-item, clinician-rated scale that assesses depressive symptoms. The HAMD-17 consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The HAMD-17 total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher HAMD-17 scores indicate more severe depression.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
827332|NCT01197508|Secondary|Sustained Remission, Defined as a MADRS Total Score of ≤8 at Week 12, Week 14, and End of Treatment (Week 16)|"The percentage of patients with a MADRS total score of ≤8 at Week 12, Week 14, and end of treatment (Week 16)was calculated.
MADRS is 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Week 12, Week 14, Week 16|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||percentage of participants analyzed|||Number
827333|NCT01197508|Secondary|Sustained Response, Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score and a MADRS Total Score of ≤12 at Week 12, Week 14, and End of Treatment (Week 16)|"The percentage of patients with a ≥50% reduction from randomization (Week 8) in MADRS total score and a MADRS total score of ≤12 at Week 12, Week 14, and end of treatment (Week 16) was calculated.
MADRS is 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Randomization (Week 8) to end of treatment (Week 16); Week 12, Week 14, and Week 16|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||percentage of patients analyzed|||Number
827334|NCT01197508|Secondary|Early and Sustained Response, Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score and a MADRS Total Score of ≤12 at Week 10, Week 12, Week 14, and End of Treatment (Week 16)|"The percentage of patients with a ≥50% reduction from randomization (Week 8) in MADRS total score and a MADRS total score of ≤12 at Week 10, Week 12, Week 14, and end of treatment (Week 16) was calculated.
MADRS is 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Randomization (Week 8) to end of treatment (Week 16); Week 10, Week 12, Week 14, and Week 16|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||percentage of participants analyzed|||Number
827335|NCT01197508|Secondary|Remission in Depressive Symptoms of MDD, Defined as MADRS Total Score of ≤8 at End of Treatment (Week 16)|"The percentage of patients with a MADRS total score of ≤8 at end of treatment (Week 16) was calculated.
MADRS is 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Week 16|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||percentage of participants analyzed|||Number
827336|NCT01197508|Secondary|Response in Depressive Symptoms of Major Depressive Disorder (MDD), Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score at End of Treatment (Week 16)|"The percentage of patients with a ≥50% reduction from randomization (Week 8) in MADRS total score at end of treatment (Week 16) was calculated.
MADRS is 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||percentage of participants analyzed|||Number
827337|NCT01197508|Primary|Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Randomization to End of Treatment.|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
827338|NCT01197521|Secondary|SF-36 - Comparison of the Change in MCS From Baseline Between Fostamatinib and Placebo at Week 24|SF-36: 36 item Short Form Health Survey, a measure of health-related QoL. Scores for 8 sub-domains (Physical Functioning, Role-physical, Bodily Pain, General Health, Vitality, Social Function, Role-emotional & Mental Health) are derived & normalised to a scale of 0-100. Mental Component Scores (MCS) are derived by multiplying each of these 8 scores by a constant, summing them & standardising against a population with mean of 50, standard deviation of 10. Higher scores represent a better QoL. Mean changes from baseline score are presented at each visit as increases from baseline (defined as post-baseline minus baseline); larger changes indicate a better clinical condition. ANCOVA=analysis of covariance, BID=twice daily, DMARD=disease modifying antirheumatic drug, PO=orally, QD=once daily, QoL=quality of life.|Baseline and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle||Units on a scale||Standard Deviation|Mean
827339|NCT01197521|Secondary|SF-36 - Comparison of the Change in PCS From Baseline Between Fostamatinib and Placebo at Week 24|SF-36: 36 item Short Form Health Survey, a measure of health-related QoL. Scores for 8 sub-domains (Physical Functioning, Role-physical, Bodily Pain, General Health, Vitality, Social Function, Role-emotional & Mental Health) are derived & normalised to a scale of 0-100. Physical Component Scores (PCS) are derived by multiplying each of these 8 scores by a constant, summing them & standardising against a population with mean of 50, standard deviation of 10. Higher scores represent a better QoL. Mean changes from baseline score are presented at each visit as increases from baseline (defined as post-baseline minus baseline); larger changes indicate a better clinical condition. ANCOVA=analysis of covariance, BID=twice daily, DMARD=disease modifying antirheumatic drug, PO=orally, QD=once daily, QoL=quality of life.|Baseline and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle||Units on a scale||Standard Deviation|Mean
827340|NCT01197521|Secondary|HAQ-DI Response - Comparison of the Change (>=0.22) From Baseline Between Fostamatinib and Placebo at Week 24|HAQ-DI: Health Assessment Questionnaire – Disability Index, a measure of physical function. The HAQ-DI score is calculated by summing scores from 8 sub-categories (ie, scores for patient ability in dressing and grooming, rising, eating, walking, hygiene, reach, grip and common daily activities) and dividing by the number of categories completed. The HAQ-DI score takes values between 0 and 3, with higher score indicating greater disability. HAQ-DI response: a reduction from baseline in HAQ-DI greater than or equal to the minimally important difference (0.22). BID=twice daily, DMARD=disease-modifying anti-rheumatic drug, OR=odds ratio, PO=orally, QD=once a day.|Baseline and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Percentage of responders|||Number
827341|NCT01197521|Secondary|Proportion of Patients Achieving DAS28-CRP EULAR Response at Week 24|Change in DAS28 was derived for each post baseline scheduled assessment and categorised using the European League Against Rheumatism (EULAR) response criteria. Non-responder imputation has been applied by carrying the baseline observation forward. BID=twice daily, CRP=C-reactive protein, DAS28=Disease Activity Score based on a 28-joint count, DMARD=disease-modifying anti-rheumatic drug, OR=odds ratio, PO=orally, QD=once a day.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Percentage of responders|||Number
827342|NCT01197521|Secondary|Proportion of Patients Achieving DAS28-CRP <2.6 at Week 24|DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patient's own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. A DAS28-CRP score of <2.6 is indicative of remission of RA symptoms. BID=twice daily, CRP=C-reactive protein, DMARD=Disease-modifying anti-rheumatic drug, OR=odds ratio, PO=orally, QD=once a day.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Percentage of responders|||Number
827343|NCT01197521|Secondary|Proportion of Patients Achieving DAS28-CRP <2.6 at Week 12|DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patient's own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. A DAS28-CRP score of <2.6 is indicative of remission of RA symptoms. BID=twice daily, CRP=C-reactive protein, DMARD=Disease-modifying anti-rheumatic drug, OR=odds ratio, PO=orally, QD=once a day.|12 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Percentage of responders|||Number
827344|NCT01197521|Secondary|ACRn - Comparison Between Fostamatinib and Placebo at Week 24|ACRn: American College of Rheumatology index of RA improvement, based on smallest percentage improvement in the count of swollen joints (out of 28 joints), count of tender joints (out of 28 joints), or in blood test measures of inflammation (such as CRP) or the physician or patient's own assessments of disease activity, pain and physical function. Scores are reported as a percentage improvement on a scale of -100 to +100, with larger values representing a better clinical outcome. BID=twice daily, CI=confidence interval, CRP=C-reactive protein, DMARD=Disease-modifying anti-rheumatic drug, PO=orally, QD=once a day, RA=rheumatoid arthritis. Mean refers to change at Week 24.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Percentage improvement from baseline||Standard Deviation|Mean
827345|NCT01197521|Secondary|Proportion of Patients Achieving ACR70 up to Week 24|ACR70: American College of Rheumatology 70% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function. Non-responder imputation has been applied by carrying the baseline observation forward. BID=twice daily, CRP=C-reactive protein, DMARD=Disease-modifying anti-rheumatic drug, PO=orally, QD=once a day.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Percentage of responders|||Number
827346|NCT01197521|Secondary|Proportion of Patients Achieving ACR50 up to Week 24|ACR50: American College of Rheumatology 50% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function. Non-responder imputation has been applied by carrying the baseline observation forward. BID=twice daily, CRP=C-reactive protein, DMARD=Disease-modifying anti-rheumatic drug, PO=orally, QD=once a day.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Percentage of responders|||Number
827450|NCT01206582|Primary|Venous Plasma Heme-oxygenase 1 (HO1) Protein Concentration|HO1 protein concentration levels in plasma were assessed with a HO1 (human) enzyme-linked immunosorbent assay (ELISA) kit.|baseline, day 3, day 7, day 56|Total number of subjects analyzed varied per time period due to discontinuations, subject and data availability. Subjects analyzed are presented per category as (n=hemin, albumin arms).||ng/mL||Standard Error|Mean
827347|NCT01197521|Secondary|ACR20 - Proportion of Patients Achieving ACR20, Comparison Between Fostamatinib and Placebo at Week 1|ACR20: American College of Rheumatology 20% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function. Non-responder imputation has been applied by carrying the baseline observation forward. BID=twice daily, CRP=C-reactive protein, DMARD=Disease-modifying anti-rheumatic drug, PO=orally.|1 week|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Percentage of responders|||Number
827348|NCT01197521|Primary|Change From Baseline to Week 24 in mTSS, Comparison Between Fostamatinib and Placebo.|mTSS: modified total Sharp score, a measure of structural progression based upon X-rays. Hand and foot joints are scored for erosions and joint space narrowing and the results summed to give a value between 0 and 448. A higher value represents more serious progression of the disease. After disregarding ineligible records, patients with 2 or more non-missing values have had missing data imputed via linear extrapolation/interpolation methods. Patients with only 1 result have been excluded from the analysis. ANCOVA=analysis of covariance, BID=twice daily, DMARD=disease-modifying anti-rheumatic drug, IP=investigational product, PO=orally, QD=once a day.|Baseline and 24 weeks|The full analysis set includes those patients who received at least 1 dose of IP. Patients were analysed by randomised treatment. Measurements at 2 timepoints are required in order for a patient to be included in the analysis; therefore patients with only 1 result have been excluded from the analysis population.||Units on a scale||Standard Deviation|Mean
827349|NCT01197521|Primary|Proportion of Patients With ACR20 at Week 24, Comparison Between Fostamatinib and Placebo.|ACR20: American College of Rheumatology 20% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function. Non-responder imputation has been applied by carrying the baseline observation forward. BID=twice daily, CRP=C-reactive protein, DMARD=disease-modifying anti-rheumatic drug, PO=orally, QD=once a day.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Percentage of responders|||Number
827350|NCT01197534|Secondary|SF-36 - Comparison of the Change in MCS From Baseline Between Fostamatinib and Placebo at Week 24|SF-36: 36-item Short Form Health Survey, a measure of health related quality of life. Scores for 8 sub-domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Function, Role-Emotional and Mental Health) are derived and normalised to a scale of 0-100. Physical and mental component scores (PCS and MCS) are derived by multiplying each of these 8 scores by a constant, summing them and standardising against a population with mean of 50+/- 10. Higher scores represent a better quality of life. Mean changes from baseline score are presented as increases from baseline (defined as post-baseline minus baseline); larger changes indicate a better clinical condition. ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease modifying antirheumatic drugs, PO = orally, QD = once a day.|Baseline and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Units on a scale||Standard Deviation|Mean
827351|NCT01197534|Secondary|SF-36 - Comparison of the Change in PCS From Baseline Between Fostamatinib and Placebo at Week 24|SF-36: 36-item Short Form Health Survey, a measure of health related quality of life. Scores for 8 sub-domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Function, Role-Emotional and Mental Health) are derived and normalised to a scale of 0-100. Physical and mental component scores (PCS and MCS) are derived by multiplying each of these 8 scores by a constant, summing them and standardising against a population with mean of 50+/- 10. Higher scores represent a better quality of life. Mean changes from baseline score are presented as increases from baseline (defined as post-baseline minus baseline); larger changes indicate a better clinical condition. ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease modifying antirheumatic drugs, PO = orally, QD = once a day.|Baseline and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Units on a scale||Standard Deviation|Mean
827352|NCT01197534|Secondary|Change From Baseline to Week 24 in mTSS, Comparison Between Fostamatinib and Placebo|mTSS: modified total sharp score, a measure of structural progression based upon X-rays. Hand and foot joints are scored for erosions and joint space narrowing and the results summed to give a value between 0 and 448. A higher value represents more serious progression of the disease. After disregarding ineligible records, patients with 2 or more non-missing values have had missing data imputed via linear extrapolation/interpolation methods. Patients with only 1 result were excluded from the analysis. ANCOVA = analysis of covariance, BID = twice daily, IP = investigational product, QD = once a day.|Baseline and 24 weeks|The full analysis set includes patients who received at least 1 dose of IP. Patients were analysed by randomised treatment in accordance with the intention to treat principle. Measurements at 2 timepoints are required for a patient to be included in the analysis; therefore patients with only 1 result have been excluded from the analysis population.||Units on a scale||Standard Deviation|Mean
827353|NCT01197534|Secondary|HAQ-DI Response - Comparison of the Change(>=0.22) From Baseline Between Fostamatinib and Placebo at Week 24|HAQ-DI: Health Assessment Questionnaire – Disability Index, a measure of physical function. The HAQ-DI score is then calculated by summing the category scores from 8 sub-categories (ie, scores for patient ability in dressing and grooming, rising, eating, walking, hygiene, reach, grip and common daily activities) and dividing by the number of categories completed. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability. The HAQ-DI response is a reduction from baseline in HAQ-DI score greater than or equal to the minimally important difference (0.22). BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, OR = odds ratio, PO = orally, QD = once a day.|Baseline and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Percentage of responders|||Number
827451|NCT01206595|Secondary|Number of Patients With Adverse Events|All adverse events were to be recorded from the time of dosing through Day 8. Serious adverse events (SAEs) were to be recorded through Day 30.|Through 30 days postdose||||||
827354|NCT01197534|Secondary|Proportion of Patients Achieving DAS28 EULAR Response at Week 24|Change in DAS28 was derived for each post baseline scheduled assessment and categorised using the European League Against Rheumatism (EULAR) response criteria. BID = twice daily, DAS28 = Disease Activity Score based on a 28-joint count, DMARD = disease-modifying anti-rheumatic drug, OR=odds ratio, PO = orally, QD = once a day.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Percentage of responders|||Number
827355|NCT01197534|Secondary|Proportion of Patients Achieving DAS28-CRP <2.6 at Week 24, Comparison Between Fostamatinib and Placebo|DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patient's own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. A DAS28-CRP score of <2.6 is indicative of remission of RA symptoms. BID = twice daily, CRP = C-reactive protein, DMARD = Disease-modifying anti-rheumatic drug, OR=odds ratio, PO = orally, QD=once a day.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Percentage of responders|||Number
827356|NCT01197534|Secondary|Proportion of Patients Achieving DAS28-CRP <2.6 at Week 12, Comparison Between Fostamatinib and Placebo|DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patient's own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. A DAS28-CRP score of <2.6 is indicative of remission of RA symptoms. BID = twice daily, CRP = C-reactive protein, DMARD = Disease-modifying anti-rheumatic drug, OR = odds ratio, PO = orally, QD = once a day.|12 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Percentage of responders|||Number
827357|NCT01197534|Secondary|ACRn - Comparison Between Fostamatinib and Placebo at Week 24|ACRn: American College of Rheumatology index of RA improvement, based on smallest percentage improvement in the count of swollen joints (out of 28 joints), count of tender joints (out of 28 joints), or in blood test measures of inflammation (such as CRP) or the physician or patient’s own assessments of disease activity, pain and physical function. Scores are reported as a percentage improvement on a scale of -100 to +100, with larger values representing a better clinical outcome. BID = twice daily, CI = confidence interval, CRP = C-reactive protein, DMARD = Disease-modifying anti-rheumatic drug, PO = orally, QD = once a day. Mean refers to change at Week 24.|Baseline and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Percentage improvement from baseline||Standard Deviation|Mean
827358|NCT01197534|Secondary|Proportion of Patients Achieving ACR70, Comparison Between Fostamatinib and Placebo at Week 24|ACR70: American College of Rheumatology 70% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient’s own assessments of disease activity, pain and physical function. BID = twice daily, CRP = C-reactive protein, DMARD = Disease-modifying anti-rheumatic drug, PO = orally, QD = once a day.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Percentage of responders|||Number
827359|NCT01197534|Secondary|Proportion of Patients Achieving ACR50, Comparison Between Fostamatinib and Placebo at Week 24|ACR50: American College of Rheumatology 50% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient’s own assessments of disease activity, pain and physical function. BID = twice daily, CRP = C-reactive protein, DMARD = Disease-modifying anti-rheumatic drug, PO = orally, QD = once a day.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Percentage of responders|||Number
827360|NCT01197534|Secondary|Proportion of Patients Achieving ACR20, Comparison Between Fostamatinib and Placebo at Week 1|ACR20: American College of Rheumatology 20% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient’s own assessments of disease activity, pain and physical function. BID = twice daily, CRP = C-reactive protein, DMARD = Disease-modifying anti-rheumatic drug, PO = orally, QD = once a day.|1 week|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Percentage of responders|||Number
827361|NCT01197534|Primary|Proportion of Patients With ACR20 at Week 24, Comparison Between Fostamatinib and Placebo|ACR20: American College of Rheumatology 20% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient’s own assessments of disease activity, pain and physical function. BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once a day.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Percentage of responders|||Number
827362|NCT01197547|Secondary|Serious Adverse Device Effect (SADE)|A secondary endpoint of the Genesys HTA Post Approval Study is to assess Serious Adverse Device Effects. Per the approved protocol, an SADE is an adverse device effect resulting in any of the consequences characteristic of a serious adverse event, or that might have led to any of these consequences if suitable action had not been taken or intervention had not been made, or if circumstances had been less opportune.|Day 1|992 - Intent-To-Treat (ITT) population||number of participants|participants||Number
827363|NCT01197547|Secondary|Technical Malfunctions|A secondary endpoint of the Genesys HTA Post Approval Study is to assess technical complaints (i.e. disposable and hardware issues). Technical complaints are issues related to system components encountered during the procedure such as error messages, problems with the connection, power, early incomplete procedure terminations, or display/user interface, or damage to the unit.|Day 1|992 patients = ITT population||percent of participants||95% Confidence Interval|Number
827364|NCT01197547|Primary|Burn Rate||Day 1|||participants|||Number
827365|NCT01197560|Secondary|Stage 2: Health Related Quality of Life for Diffuse Large B-Cell Lymphoma (DLBCL) Patients|The European Organization for Research and Treatment of Cancer QOL Questionnaire for Patients with Cancer (EORTC QLQ-C30) is a 30-item oncology-specific questionnaire developed to assess the quality of life of cancer patients. The descriptive system EQ-5D is a generic questionnaire consisting of 3 levels within each of the 5 domains. It’s is a standardized instrument for use as a measure of health outcome and provides a simple descriptive profile and a single index value for health status||According to the Stage 1 results as assessed by the independent response adjudication committee (IRAC), neither subtype met the pre specified requirement to be further studied in Stage 2. Study terminated after Stage 1 completed and before Stage 2 started.|||||
827366|NCT01197560|Secondary|Stage 2: Time to Progression for Diffuse Large B-Cell Lymphoma (DLBCL) Participants|Time to progression is defined as the time from the start of study drug therapy to the first documentation of disease progression||According to the Stage 1 results as assessed by the independent response adjudication committee (IRAC), neither subtype met the pre specified requirement to be further studied in Stage 2. Study terminated after Stage 1 completed and before Stage 2 started.|||||
827367|NCT01197560|Secondary|Stage 2: Overall Response Rate for Diffuse Large B-Cell Lymphoma (DLBCL) Patients With a Duration of Response Lasting ≥ 16 Weeks|"Response was defined as participants with a complete response (CR), unconfirmed complete response (CRu) or partial response (PR), based on IWG Response Criteria for NHL (Cheson1999) as evaluated by the Independent Response Assessment Committee (IRAC).
Complete Response (CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers.
CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM.
Partial Response (PR) is a 50% decrease in the sum of the products of diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes"||According to the Stage 1 results as assessed by the independent response adjudication committee (IRAC), neither subtype met the pre specified requirement to be further studied in Stage 2. Study terminated after Stage 1 completed and before Stage 2 started.|||||
827368|NCT01197560|Secondary|Stage 2: Duration of Complete Response for Diffuse Large B-Cell Lymphoma (DLBCL) Participants|Duration of Complete Response was to be calculated for complete responders as the time of from documented initial complete response (either CR or CRu) until documented disease progression determined by CT or MRI scan, or death, whichever occurs earlier.||According to the Stage 1 results as assessed by the independent response adjudication committee (IRAC), neither subtype met the pre specified requirement to be further studied in Stage 2. Study terminated after Stage 1 completed and before Stage 2 started.|||||
827369|NCT01197560|Secondary|Stage 2: Overall Survival (OS) for Diffuse Large B-Cell Lymphoma (DLBCL) Participants|Overall Survival (OS) is defined as the time from randomization until death due to any cause.||According to the Stage 1 results as assessed by the independent response adjudication committee (IRAC), neither subtype met the pre specified requirement to be further studied in Stage 2. Study terminated after Stage 1 completed and before Stage 2 started.|||||
827370|NCT01197560|Secondary|Stage 2: Duration of Overall Response for Diffuse Large B-Cell Lymphoma (DLBCL) Participants|Length of time of overall response (Complete Response + Complete Response unconfirmed + Partial Response) was to be calculated for responders as the time from documented initial response (either CR, CRu, or PR) until documented disease progression determined by CT or MRI scan, or death, whichever occurs earlier.|Approximately 3.5 years|According to the Stage 1 results as assessed by the independent response adjudication committee (IRAC), neither subtype met the pre specified requirement to be further studied in Stage 2. Study terminated after Stage 1 completed and before Stage 2 started.|||||
827371|NCT01197560|Secondary|Stage 2: Overall Response Rate for Diffuse Large B-Cell Lymphoma (DLBCL) Participants|"Response was defined as participants with a complete response (CR), unconfirmed complete response (CRu) or partial response (PR), based on IWG 1999 Response Criteria for NHL (Cheson1999) as evaluated by the Independent Response Assessment Committee (IRAC).
Complete Response (CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers.
CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM.
Partial Response (PR) is a 50% decrease in the sum of the products of diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes"||According to the Stage 1 results as assessed by the independent response adjudication committee (IRAC), neither subtype met the pre specified requirement to be further studied in Stage 2. Study terminated after Stage 1 completed and before Stage 2 started.|||||
827372|NCT01197560|Secondary|Stage 2: Complete Response Rate for Diffuse Large B-Cell Lymphoma (DLBCL) Participants|"Complete Response Rate (CR + CRu rate) was to be calculated as the proportion of participants achieving a CR or CRu using 1999 IWG Response Criteria, (Cheson, 1999).
CR: Complete disappearance of all detectable clinical and radiographic evidence of disease, disappearance of any disease-related symptoms, and normalization of biochemical abnormalities.
Cru: Criteria for CR above but with 1 or more of the following:
A residual lymph node mass > 1.5 cm in greatest transverse diameter that has regressed by more than 75% in the sum of the products of diameters (SPD) Indeterminate bone marrow (increased number or size of aggregates without cytologic or architectural atypia)."||According to the Stage 1 results as assessed by the independent response adjudication committee (IRAC), neither subtype met the pre specified requirement to be further studied in Stage 2. Study terminated after Stage 1 completed and before Stage 2 started.|||||
827373|NCT01197560|Primary|Stage 2: Progression-free Survival for Diffuse Large B-Cell Lymphoma (DLBCL) Participants|Number of participants who survive without progressing based on the International Working Group Response Criteria [IWG].||According to the Stage 1 results as assessed by the independent response adjudication committee (IRAC), neither subtype met the pre-specified requirement to be further studied in Stage 2. Study terminated after Stage 1 completed and before Stage 2 started.|||||
827452|NCT01206595|Primary|Time to First Use of Supplemental Pain Medication Postoperatively for Surgical Pain|The primary efficacy endpoint was the time to first use of supplemental pain medication (opioid or non-opioid) postoperatively for surgical pain.|Through 96 hours postdose|||hours||Inter-Quartile Range|Median
827374|NCT01197560|Primary|Stage 1: Percentage of Participants With an Overall Response Rate (ORR) According to the International Working Group (IWG) Response Criteria for Non Hodgkin's Lymphoma (NHL), Cheson 1999.|"Response was defined as participants with a complete response (CR), unconfirmed complete response (CRu) or partial response (PR), based on IWG 1999 Response Criteria for NHL as evaluated by the Independent Response Adjudication Committee (IRAC).
Complete Response (CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers.
CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM.
Partial Response (PR) is a 50% decrease in the sum of the products of diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes"|From Sept 2010 to the data cut-off of 4 July 2013; when all participants had reached the scheduled 16-week assessment or had progressed/died before the scheduled 16-week assessment). Median follow-up time was 6.7 and 4.7 months in each arm respectively|The Modified Intent to Treat (mITT ) population was defined as all participants randomized who had a DLBCL diagnosis and either Germinal Center B-cell subtype (GCB) or non-GCB subtype confirmed by Central Pathology, and who received at least one dose of study drug (lenalidomide or Investigator’s choice).||percentage of participants||95% Confidence Interval|Number
827375|NCT01197755|Secondary|SF-36 - Comparison of the Change in MCS From Baseline Between Fostamatinib and Placebo at Week 24|SF-36: 36 item short form health survey, as a measure of health-related quality of life. The SF-36 scores for 8 sub-domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Function, Role-Emotional and Mental Health) are derived and normalised to a scale of 0 to 100. The physical and mental component scores (PCS and MCS) are derived by multiplying each of these 8 scores by a constant, summing them and standardising against a population with a mean of 50, standard deviation of 10. A higher score represents a better quality of life. Mean changes from baseline score are presented as increases from baseline (defined as post-baseline minus baseline); larger changes indicate a better clinical condition. Mean refers to change in score at Week 24. ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease modifying antirheumatic drugs, PO = orally, QD = once daily.|Baseline and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Units on a scale||Standard Deviation|Mean
827376|NCT01197755|Secondary|SF-36 - Comparison of the Change in PCS From Baseline Between Fostamatinib and Placebo at Week 24|SF-36: 36 item short form health survey, as a measure of health-related quality of life. Scores for 8 sub-domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Function, Role-Emotional and Mental Health) are derived and normalised to a scale of 0 to 100. The physical and mental component scores (PCS and MCS) are derived by multiplying each of these 8 scores by a constant, summing them and standardising against a population with a mean of 50, standard deviation of 10. A higher score represents a better quality of life. Mean changes from baseline score are presented as increases from baseline (defined as post-baseline minus baseline); larger changes indicate a better clinical condition. Mean refers to change in scores at Week 24. ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease modifying antirheumatic drugs, PO = orally, QD = once daily|Baseline and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Units on a scale||Standard Deviation|Mean
827377|NCT01197755|Secondary|Change From Baseline to Week 24 in mTSS Score, Comparison Between Fostamatinib and Placebo|mTSS: modified total sharp score, a measure of structural progression based upon X-rays. Hand and foot joints are scored for eroisions and joint space narrowing and the results summed to give a value between 0 and 488. A higher value represents more serious progression of the disease. After disregarding ineligible records, patients with 2 or more non-missing values had missing data imputed via linear extrapolation/interpolation methods. Patients with only 1 result were excluded from the analysis. ANCOVA = Analysis of covariance, BID = twice daily, IP = investigational product, PO = orally, QD = once a day.|Baseline and 24 weeks|The full analysis set includes patients who received at least 1 dose of IP. Patients were analysed by randomised treatment in accordance with the intention to treat principle. Measurements at 2 timepoints are required for a patient to be included in the analysis; therefore patients with only 1 result have been excluded from the analysis population.||Units on a scale||Standard Deviation|Mean
827378|NCT01197755|Secondary|Proportion of Patients With a HAQ-DI Response at Week 24 - Comparison Between Fostamatinib and Placebo|HAQ-DI: Health Assessment Questionnaire - Disability Index, a measure of physical function. The HAQ-DI score is calculated by summing the category scores from 8 sub-categories (ie, scores for patient ability in dressing and grooming, rising, eating, walking, hygeine, reach, grip and common daily activities) and dividing by the number of categories completed. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability. A HAQ-DI response is a reduction from baseline in HAQ-DI greater than or equal to the minimally important difference (0.22). BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, OR = odds ratio, PO = orally, QD = once a day.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Percentage of responders|||Number
827379|NCT01197755|Secondary|Proportion of Patients Achieving DAS28-CRP EULAR Response at Week 24, Comparison Between Fostamatinib and Placebo|Change from baseline in DAS28-CRP at Week 24 was categorised using the European League Against Rheumatism (EULAR) response criteria. BID = twice daily, CRP = C-reactive protein, DAS28 = Disease Activity Score based on a 28-joint count, DMARD = disease-modifying anti-rheumatic drug, OR = odds ratio, PO = orally, QD = once a day.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Percentage of responders|||Number
827419|NCT01206140|Primary|Progression-free Survival|Progression-free survival was estimated using the product-limit method of Kaplan and Meier. Progression wasl evaluated in this study using the Response Evaluation Criteria in Solid Tumors (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions, or death.|Until disease progression or death, up to 4.5 years|||months||95% Confidence Interval|Median
827380|NCT01197755|Secondary|Proportion of Patients Achieving DAS28-CRP <=3.2 at Week 12, Comparison Between Fostamatinib and Placebo|DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patients' own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. A DAS28-CRP score of <=3.2 indicates low disease activity. BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, OR = odds ratio, PO = orally, QD = once daily.|12 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Percentage of responders|||Number
827381|NCT01197755|Secondary|Proportion of Patients Achieving DAS28-CRP <2.6 at Week 24, Comparison Between Fostamatinib and Placebo|DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patients' own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. A DAS28-CRP score of <2.6 is indicative of remission of RA symptoms. BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, OR = odds ratio, PO = orally, QD = once daily.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Percentage of responders|||Number
827382|NCT01197755|Secondary|ACRn - Comparison Between Fostamatinib and Placebo at Week 24|ACRn: American College of Rheumatology index of RA improvement, based on smallest percentage improvement in the count of swollen joints (out of 28 joints), count of tender joints (out of 28 joints), or in blood test measures of inflammation (such as C-Reactive Protein) or the physician or patient's own assessments of disease activity, pain and physical function. Scores are reported as a percentage improvement on a scale of -100 to +100, with larger values representing a better clinical outcome. Mean refers to change at Week 24. BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once a day.|Baseline and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Percentage improvement from baseline||Standard Deviation|Mean
827383|NCT01197755|Secondary|Proportion of Patients Achieving ACR70 at Week 24, Comparison Between Fostamatinib and Placebo|ACR70: American College of Rheumatology 70% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as C-Reactive Protein) and the physician and patient's own assessments of disease activity, pain and physical function. BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once daily.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Percentage of responders|||Number
827384|NCT01197755|Secondary|Proportion of Patients Achieving ACR50 at Week 24, Comparison Between Fostamatinib and Placebo|ACR50: American College of Rheumatology 50% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as C-Reactive Protein) and the physician and patient's own assessments of disease activity, pain and physical function. BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once daily.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Percentage of responders|||Number
827385|NCT01197755|Secondary|Proportion of Patients Achieving ACR20 at Week 1, Comparison Between Fostamatinib and Placebo|ACR20: American College of Rheumatology 20% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as C-Reactive Protein) and the physician and patient's own assessments of disease activity, pain and physical function. BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once daily.|1 week|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Percentage of responders|||Number
827386|NCT01197755|Primary|Proportion of Patients Achieving ACR20 at Week 24, Comparison Between Fostamatinib and Placebo|ACR20: American College of Rheumatology 20% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as C-Reactive Protein) and the physician and patient's own assessments of disease activity, pain and physical function. BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once daily.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Percentage of responders|||Number
827387|NCT01197794|Secondary|Total Reliever Medication Use|Reliever medication use (number of inhalations), measured in the morning and evening. Total reliever medication use is calculated by taking the sum of the number of daytime and evening inhalations of reliever medication. Change from baseline: treatment period average minus baseline.|Twelve week treatment period|The full analysis set consist of all randomized participants who received at least one dose of study medication and contributed sufficient data for at least the primary or secondary efficacy endpoint||Number of inhalations||95% Confidence Interval|Least Squares Mean
827388|NCT01197794|Secondary|Asthma Symptom Score|Asthma symptoms, measured in the morning and evening, based on a scale from 0-3 with higher scores indicating more severe asthma symptoms. Total asthma symptom score (0-6) is calculated by taking the sum of the morning and evening scores. Change from baseline: treatment period average minus baseline.|Twelve week treatment period|The full analysis set consist of all randomized participants who received at least one dose of study medication and contributed sufficient data for at least the primary or secondary efficacy endpoint||Score on scale||95% Confidence Interval|Least Squares Mean
827389|NCT01197794|Secondary|Asthma Quality of Life Questionnaire (AQLQ(S))|The AQLQ(S) consists of 32 questions, each assessed on a scale from 1-7, with higher values indicating better health-related quality of life. Overall scores are calculated from the means of the individual scores. The minimal important difference is a change in score of 0.5. Change from baseline: treatment period average minus baseline.|Twelve week treatment period|The full analysis set consist of all randomized participants who received at least one dose of study medication and contributed sufficient data for at least the primary or secondary efficacy endpoint||Score on scale||95% Confidence Interval|Least Squares Mean
827390|NCT01197794|Secondary|Number of Participants With Well-controlled Asthma (ACQ5<=0.75)|The ACQ5 consists of 5 questions, each assessed on a scale from 0-6, where 0 represents good asthma control and 6 represents poor asthma control. The overall score is the mean of the responses. Well-controlled asthma is defined as ACQ5<=0.75 at the end of the 12-week treatment period.|Twelve week treatment period|The full analysis set consist of all randomized participants who received at least one dose of study medication and contributed sufficient data for at least the primary or secondary efficacy endpoint||Participants|||Number
827391|NCT01197794|Secondary|Number of Participants With at Least One Treatment Failure|Treatment failure is defined as a clinical need for additional inhaled corticosteroid use as judged by the investigator based on evaluations at the clinic.|Twelve week treatment period|The full analysis set consist of all randomized participants who received at least one dose of study medication and contributed sufficient data for at least the primary or secondary efficacy endpoint||Participants|||Number
827392|NCT01197794|Secondary|Number of Participants With at Least One Severe Asthma Exacerbation|Severe asthma exacerbation defined as deterioration in asthma leading to either hospitalization/emergency room treatment or oral glucocorticosteroid treatment for at least 3 days|Twelve week treatment period|The full analysis set consist of all randomized participants who received at least one dose of study medication and contributed sufficient data for at least the primary or secondary efficacy endpoint||Participants|||Number
827393|NCT01197794|Secondary|Adverse Events|Number of participants who had at least one adverse event during the randomized treatment period|Twelve week treatment period|All randomized participants who received at least one dose of study medication and from whom any data after randomization was available||Participants|||Number
827394|NCT01197794|Secondary|Asthma Control Questionnaire 5-item (ACQ5)|The ACQ5 consists of 5 questions, each assessed on a scale from 0-6, where 0 represents good asthma control and 6 represents poor asthma control. The overall score is the mean of the responses. The minimal important difference is defined as a change in score of 0.5. Change from baseline: treatment period average minus baseline.|Twelve week treatment period|The full analysis set consist of all randomized participants who received at least one dose of study medication and contributed sufficient data for at least the primary or secondary efficacy endpoint||Scores on scale||95% Confidence Interval|Least Squares Mean
827395|NCT01197794|Secondary|Morning and Evening PEF|Change from baseline: treatment period average minus baseline. Treatment period average defined as the mean of all available morning (evening) PEF during randomized treatment that occurred on or prior to treatment failure. Treatment failure defined as worsening asthma symptoms resulting in increased dose of inhaled corticosteroid.|Twelve week treatment period|The full analysis set consist of all randomized participants who received at least one dose of study medication and contributed sufficient data for at least the primary or secondary efficacy endpoint||Liters/minute||95% Confidence Interval|Least Squares Mean
827396|NCT01197794|Primary|Pre-bronchodilator FEV1 at the Clinic|Change from baseline: treatment period average minus baseline. Treatment period average defined as the mean of all available data during randomized treatment that occurred on or prior to treatment failure. Treatment failure defined as worsening asthma symptoms resulting in increased dose of inhaled corticosteroid.|Twelve week treatment period|The full analysis set consist of all randomized participants who received at least one dose of study medication and contributed sufficient data for at least the primary or secondary efficacy endpoint||Liters||95% Confidence Interval|Least Squares Mean
827397|NCT01197833|Primary|Absolute Change From Baseline in PA-V3 Score|The Patient Self-assessment of Visible Varicose Veins (PA-V3) instrument is a 5-point scale used by patients to evaluate the appearance of their visible varicose veins. On this paper questionnaire, the instructions included a diagram of the medial view of a leg with the area between the ankle and the groin circled. The patient was instructed to choose 1 of 5 response options that best described the appearance of the visible varicose veins of the leg that was treated in the study. The patient was instructed not to consider the appearance of the leg outside the circled area or of any spider veins. Possible responses ranged from “Not at all noticeable” (a score of 0) to “Extremely noticeable” (a score of 4)|PA-V3 measured at baseline and then at 8 weeks|||score||Standard Error|Least Squares Mean
827398|NCT01197833|Primary|Absolute Change From Baseline in Independent Photography Review (IPR-V3 Score)|The Independent Photography Review – Visible Varicose Veins (IPR-V3) instrument is a 5-point scale used to assess the appearance of a patient’s visible varicose veins. At screening, the site clinician was instructed to review the appearance of the patient’s varicose veins in the medial section of each leg (a ‘live’ assessment), then select an IPR-V3 score (i.e., none=0, mild, moderate, severe or very severe=4) that best represented the appearance of the patient’s varicose veins. This assessment took into account the attributes caliber, dilatation, tortuosity, and extent and number of varicosities, and was used to determine patient eligibility. The site clinician used a set of reference photographs (2 example photographs for each score on the scale) to assist with assigning a score to the appearance of the patient’s visible varicose veins.|IPR-V3 measured at baseline and then at 8 weeks|||score||Standard Error|Least Squares Mean
827399|NCT01203956|Secondary|Key Measures That Will be Used to Evaluate the Intervention(s)|The Epworth Sleepiness Scale will be used to evaluate sleepiness The Sleep Wake Activity Inventory will be used to evaluate sleepiness Daily diaries will be used to evaluate daily use of the device|2 weeks||||||
827400|NCT01203956|Primary|Apnea-hypopnea Index (AHI)|Number of apnea/hypopnea events per hour, measured by SmartLink component of device.|4 weeks|||events / hour||Standard Deviation|Mean
827401|NCT01204203|Secondary|Overall Survival (OS)|Overall Survival is defined as the number of days from the day the subject started treatment to the day the subject experienced death or lost to follow-up.|Baseline up to 28 months|Participants with advanced malignant pleural mesothelioma.||months||Full Range|Median
827402|NCT01204203|Secondary|Progression Free Survival (PFS)|Progression Free Survival is defined as the number of days from the day the subject started treatment to the day the subject experienced evidence of disease progression, as determined by radiological or clinical progression.|Baseline up to 28 months|Participants with advanced malignant pleural mesothelioma.||Months||Full Range|Median
827449|NCT01206582|Primary|Venous Monocyte HO1 Activity|HO1 activity in white blood cells was measured by an assay that measures bilirubin production as a marker of HO1 activity.|baseline, Day 3, Day 7, Day 56|Total number of subjects analyzed varied per time period due to discontinuations, subject and data availability. Subjects analyzed are presented per category as (n=hemin, albumin arms).||pmol bilirubin/mg/h||Standard Error|Mean
827403|NCT01204203|Primary|Tumor Response Rate Following Zoledronic Acid (Zometa)|The modified Response Evaluation Criteria in Solid Tumors Criteria (RECIST 2004) will be used for target lesions and assessed by CT scans. Complete Response (CR) is the disappearance of target lesions; Partial Response (PR) is greater than or equal to 30% reduction in the total tumor measurement; Stable Disease (SD) is the absence of response or progression; and Progressive Disease (PD) is a 20% increase in the total tumor measurement over nadir value or the appearance of new lesions.|Baseline up to 28 months or until progressive disease or death|Participants with advanced malignant pleural mesothelioma.||percentage of responders|||Number
827406|NCT01205828|Secondary|Biomarker Analysis|To evaluate biological correlation with response to ABT-888 and temozolomide, including evaluation of loss of heterozygosity (LOH) of 13q, decreased expression of or mutations in BRCA-1 or -2, and a select assortment of DNA repair genes.|6 months|Since the treatment showed no significant efficacy against HCC, therefore study of biomarker that predict responsiveness of the treatment was not carried out.|||||
827407|NCT01205828|Secondary|Number of Participants Who Had Grade 3 or 4 Adverse Events|Record of all toxicities graded according to the NCI CTCAE version 3.0|6 months|grade 3 or 4 adverse events||participants|||Number
827408|NCT01205828|Secondary|Progression Free Survival|The number of months between a patient's enrollment and his/her disease progression|2 years|||months||95% Confidence Interval|Median
827409|NCT01205828|Secondary|Overall Survival|the number of months between a patient's enrollment and his/her date of death|2 years|||months||95% Confidence Interval|Median
827410|NCT01205828|Primary|Clinical Benefit Rate|complete response at any time + partial response at any time + stable disease after 8 weeks of treatment based on RECIST Criteria|8 weeks|||participants|||Number
827411|NCT01206101|Secondary|Glucose Level Variability And Hypoglycaemia Duration Derived From The Continuous Glucose Monitoring System (CGMS)|Change from baseline in glucose level variability and hypoglycaemia at baseline, weekly during liraglutide dose escalation, at 12 weeks pre-transplant, at 24 weeks post-transplant, 52 weeks post-transplant and 56 weeks (4 weeks after withdrawal of liraglutide or liraglutide placebo)|At 12 weeks pre-transplant, at 24 weeks post-transplant, 52 weeks post-transplant and 56 weeks (4 weeks after withdrawal of liraglutide or liraglutide placebo)|Full analysis set (FAS) – all randomised subjects who underwent one or more transplantations after randomisation. Due to the premature termination of the trial prior to islet cell transplantation in any randomised subject, no formal statistical analyses were performed.|||||
827412|NCT01206101|Secondary|Change in Islet Cell Yield During Culture|Change in islet cell yield from pre-culture to post-culture|From 0 hours pre-culture to 24 hours to 72 hours|Full analysis set (FAS) – all randomised subjects who underwent one or more transplantations after randomisation. Due to the premature termination of the trial prior to islet cell transplantation in any randomised subject, no formal statistical analyses were performed.|||||
827413|NCT01206101|Secondary|Proportion of Insulin-Independent Subjects|Proportion of insulin-independent subjects among all randomised subjects who had one or more transplantations after randomisation|At 52 weeks after initial transplantation|Full analysis set (FAS) – all randomised subjects who underwent one or more transplantations after randomisation. Due to the premature termination of the trial prior to islet cell transplantation in any randomised subject, no formal statistical analyses were performed.|||||
827414|NCT01206101|Secondary|Proportion of Subjects With HbA1c Below Or Equal to 6.5% At Week 52 That Are Free From Severe Hypoglycaemic Events|Proportion of subjects with HbA1c below or equal to 6.5% at week 52 that were free from severe hypoglycaemic events|From week 0 to week 52 after initial transplantation|Full analysis set (FAS) – all randomised subjects who underwent one or more transplantations after randomisation. Due to the premature termination of the trial prior to islet cell transplantation in any randomised subject, no formal statistical analyses were performed.|||||
827415|NCT01206101|Secondary|Number of Hypoglycaemic Episodes|A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and until the last day on randomised treatment. Confirmed hypoglycaemic episodes were categorised either as minor (PG<3.1 mmol/L [56 mg/dL]) or severe (subject unable to treat himself/herself).|During week 0 to week 52|Full analysis set (FAS) – all randomised subjects who underwent one or more transplantations after randomisation. Due to the premature termination of the trial prior to islet cell transplantation in any randomised subject, no formal statistical analyses were performed.|||||
827416|NCT01206101|Primary|Proportion Of Insulin-independent Subjects After Receiving Only One (Single-Donor) Islet Cell Transplant|Proportion Of Insulin-independent Subjects After Receiving Only One (Single-Donor) Islet Cell Transplant.|At week 52 after initial transplantation|Full analysis set (FAS) – all randomised subjects who underwent one or more transplantations after randomisation. Due to the premature termination of the trial prior to islet cell transplantation in any randomised subject, no formal statistical analyses were performed.|||||
827417|NCT01206140|Secondary|4 -Month Progression-free Survival Rate.|Progression-free survival rate was calculated using the survival distribution function, and 95% confidence limits were calculated using the log-log transformation. Progression was defined using the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions, or death.|Four months|||percent of participants||95% Confidence Interval|Number
827418|NCT01206140|Secondary|Number of Participants With Objective Response|Response evaluated using the Choi criteria. CR - disappearance of all lesions and no new lesions; PR - a decrease in size (the sum of longest diameters of target lesions as defined in RECIST) of 10% or more or a decrease in tumor density (HU) of 15% or more on CT and no new lesions and no obvious progression of nonmeasurable disease; SD - does not meet the criteria for CR, PR, or PD and no symptomatic deterioration attributed to tumor progression; PD - an increase in tumor size of 10% or more and does not meet criteria of PR by tumor density (HU) on CT or new lesions or new intratumoral nodules or increase in the size of the existing intratumoral nodules. Objective response = CR+PR.|Evaluated for response after every two cycles, up to 4.5 years.|||participants|||Number
827453|NCT01206608|Secondary|Number of Participants With Adverse Events|Adverse events were monitored through Day 8 and serious adverse events through Day 30.|Through 30 days postdose||||||
827420|NCT01206322|Primary|Perfusion Outcome: Right Insular Cortex Perfusion (ml/100g/Min/mmHg)|"To determine the acute effects of a single 40-IU dose of intranasal insulin vs. placebo on cognition and regional perfusion and vasoreactivity to CO2 challenge measured by 3-D continuous arterial spin labeling (CASL) MRI at 3 Tesla in the control and diabetic groups.
Cognitive outcome: Brief Visuospatial Spatial Memory test -Total Recall (unit T Score).
Perfusion outcome: Regional vasoreactivity (ml/100g/min/mmHg)."|Acute changes within 2 hours|||ml/100g/min/mmHg||Standard Deviation|Mean
827421|NCT01206322|Primary|Cognitive Outcome: Brief Visuospatial Spatial Memory Test -Total Recall (Unit T Score)|"To determine the acute effects of a single 40-IU dose of intranasal insulin vs. placebo on cognition and regional perfusion and vasoreactivity to CO2 challenge measured by 3-D continuous arterial spin labeling (CASL) MRI at 3 Tesla in the control and diabetic groups.
Cognitive outcome: Brief Visuospatial Spatial Memory test -Total Recall (unit T Score).
Perfusion outcome: Regional vasoreactivity (ml/100g/min/mmHg).
Each participant received a single dose of intranasal insulin (INI) or placebo on day 2 and a single dose dose of insulin or placebo on day 3 in a random order.
Acute effects on baseline perfusion, regional vasoreactivity and cognition were determined within 2 hours after administration of insulin or placebo."|Acute changes within 2 hours|||T-score||Standard Deviation|Mean
827422|NCT01206387|Secondary|Mean Change From Baseline in Percent Body Surface Area (%BSA) Affected at Day 28|"Mean Change from Baseline in percent body surface area (%BSA) affected by Psoriasis
The Body Surface Area (BSA) is a numerical score used to measure the physician’s assessment of the percentage of the participant’s total BSA involved with psoriasis.
BSA = SQRT ((height (cm) X weight (kg))/3600) BSA is in m2, W is weight in kg, and H is height in cm. Total body Surface Area (BSA) in meters squared
For the %Body Surface Area Affected the Rule of Nine was be used.
Change From Baseline in Percent Body Surface Area i.e., difference of base percent values [Percent Body Surface Area at 28 days - Percent Body Surface Area at Baseline]."|Baseline and day 28|Base on intention to treat. All participant with Mean Change from Baseline in %BSA affected at Day 28||percentage of body surface area affected||Standard Deviation|Mean
827423|NCT01206387|Secondary|Mean Change From Baseline in Total Lesion Severity Scale (TLSS) (ITT)|"Mean Change from Baseline in Lesion Severity Scale-TLSS (ITT)
TLSS of psoriasis is a combined score based on physician assessment of disease severity for the Target Lesion assessed at baseline and at Day 28. The TLSS combined score included summary of individually scored induration (as 0=Clear or 1=Almost Clear, or 2=Mild, or 3=Moderate, or 4=Severe, or 5=Very Severe), erythema (as 0=Clear or 1=Almost Clear, or 2=Mild, or 3=Moderate, or 4=Severe, or 5=Very Severe), and scaling (as 0=Clear or 1=Almost Clear, or 2=Mild, or 3=Moderate, or 4=Severe, or 5=Very Severe). To be eligible for inclusion in the study, the combined score of all three signs for the Target Lesion must total at least 7 and the patient must have at least a score of 3=Moderate for plaque elevation
The first evaluation was for the change from baseline in TLSS, using a two-sided, α = 0.05 level of significance."|Baseline and day 28|Base on intention to treat. All participant with mean change from baseline in TLSS at Day 28||units on a scale||Standard Deviation|Mean
827424|NCT01206387|Secondary|Mean Change From Baseline in Physician Global Assessment (PGA) Score at Day 28 Using ITT.|"In the Physician Global Assessment of psoriasis is a score based on physician assessment of overall disease severity for all lesions assessed at baseline and at Day 28. The PGA score range: from 0 (Clear=No Psoriatic lesions, i.e. no plaque formation; no erythema, no induration, no scaling) to 5 (Very Severe=Coarse scaling with pronounced cracking and fissures. Erythema is dark red with induration. Plaques are markedly elevated with sharp and hard edges).
The first evaluation was for the change from baseline in PGA, using a two-sided, α = 0.05 level of significance. If superiority of the test product over its vehicle was demonstrated (p<0.05), then PGA change from baseline values was examined."|Baseline and day 28|All participants enrolled in this study were included in this intent-to-treat (ITT) analysis. Results are presented as observed||units on a scale||Standard Deviation|Mean
827425|NCT01206387|Primary|Treatment Success|A patient is considered a Treatment Success for the Target Lesions if the target lesion has a score of 0 or 1 on the Target Lesion Severity Score (TLSS)for each of each of the three signs and symptoms (erythema, scaling and plaque elevation).|28 days|||participants|||Number
827426|NCT01206387|Primary|Clinical Success|A patient is considered a Clinical Success if the Physician's Global Assessment (PGA) is 0 (clear) or 1 (almost clear).|28 days|Primary Efficacy Analysis at Day 28 Clinical Success (ITT)||participants|||Number
827427|NCT01206439|Secondary|Exercise Tolerance|Changes in exercise tolerance and time from baseline to 180 days.|Baseline to day 180.||||||
827428|NCT01206439|Primary|Change in Systolic and Diastolic Myocardial Function|Cannot report as only 1 patient was evaluated and data will not be able to remain anonymous.|Baseline to day 180|Insufficient data to analyze.|||||
827429|NCT01206452|Secondary|Inflammatory Cytokine Response to Ablation Procedure|Measure inflammatory marker levels, including IL-1, IL-6, IL-8, and TNF-α, 24 hours post-ablation to assess interval response to steroid administration.|24 Hours after Ablation Procedure|||pg/ml||Standard Deviation|Mean
827430|NCT01206452|Secondary|Inflammatory Cytokine Response to Ablation Procedure|Measure inflammatory marker levels, including IL-1, IL-6, IL-8, and TNF-α, immediately post-ablation in keeping with prior studies on the anti-inflammatory effects of steroids following cardiac surgery.|Immediately Post-Ablation Procedure|||pg/ml||Standard Deviation|Mean
827431|NCT01206452|Secondary|Number of Participants With Atrial Fibrillation Recurrence From 3 Months up to 6 Months|Number of AF recurrences between the two study groups as assessed by 1-month event monitor placed at 3 and 6 months post-ablation. Any episode of AF lasting greater than 30 seconds was counted as a recurrence.|From 3 months up to 6 months post-procedure|||Participants with AF recurrence|||Number
827432|NCT01206452|Secondary|Number of Participants With Atrial Fibrillation Recurrence From 0 Months up to 3 Months|Number of AF recurrences between the two study groups as assessed by inpatient telemetry in the immediate post-procedure period until discharge and 1-month event monitor placed at 3 months post-ablation. Any episode of AF lasting greater than 30 seconds was counted as a recurrence.|From 0 months up to 3 months post procedure|||Participants with AF recurrence|||Number
827433|NCT01206452|Primary|Number of Participants With Atrial Fibrillation Recurrence From 6 Months up to 12 Months|Number of AF recurrences between the two study groups as assessed by 1-month event monitor placed at 6 and 12 months post-ablation. Any episode of AF lasting greater than 30 seconds was counted as a recurrence.|From 6 months up to 12 months post-procedure|||Participants with AF recurrence|||Number
827434|NCT01206478|Secondary|Change in Non-communicating Children's Pain Checklist - Revised (NCCPC-R) Scores|Non-communicating Children’s Pain Checklist - Revised (NCCPC-R) used to measure outcome. The NCCPC-R is a 30 item measure intended to assess pain in children who are unable to speak because of cognitive or physical impairments. There are 7 sub-scales including vocal, social, facial, activity, body/limbs, physiological, and eating/sleeping. Each question has a potential score of 0 to 3. Scores are totaled for each sub-scale. Sub-scale scores are then added together for the Total Score. Total Scores can range from 0 to 90. The higher the score, the higher level of pain indicated by the child. This measure was completed by parents at week 0, week 10, and week 24.|baseline, 24 weeks|||units on a scale||Standard Deviation|Mean
827435|NCT01206478|Primary|% Calories Taken Orally|Percent Kilocalories (kcal) Obtained Orally. This measure was obtained using the 24 hour food recall, a standardized five-pass method developed by the US Department of Agriculture for use in national dietary surveillance. This measure has been widely used in several large trials and data suggest it is the most valid and reliable method of dietary assessment for children (20). The data were collected at week 0, week 10, and week 24 using standardized probes by highly trained research staff, and parents were presented with paper food models and measuring devices prior to interviews to reference during the recall. Recalls were analyzed with the Nutritional Data System for Research, version 2005; University of Minnesota, Minneapolis, MN.|baseline, 24 weeks|||change in percent kcal obtained orally||Standard Deviation|Mean
827436|NCT01206517|Primary|Terminal Phase (Elimination) Half-life (t1/2) of Asenapine|Elimination t1/2 is the time it takes for the concentration of the drug in the body to decrease by half during the elimination phase.|Predose (0 hours) and 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 36 and 48 hours after the final asenapine dose (administered on Day 7 for Cohorts 1 and 2; on Day 8 for Cohorts 3b, 3c and 3d; and on Day 12 for Cohort 3a)|All participants administered asenapine with evaluable pharmacokinetic data. Two participants in Cohort 3a and one participant in Cohort 3c did not complete the study and are excluded from pharmacokinetic analysis.||hr||Standard Deviation|Mean
827437|NCT01206517|Primary|Area Under the Plasma Concentration-time Curve From 0 to 12 Hours Post Dose (AUC0-12) of Asenapine|AUC0-12 is the area under the plasma drug-concentration time curve calculated for the 12 hour interval after dosing.|Predose (0 hours) and 0.5, 1, 1.5, 2, 3, 4, 6 and 12 hours after the final asenapine dose (administered on Day 7 for Cohorts 1 and 2; on Day 8 for Cohorts 3b, 3c and 3d; and on Day 12 for Cohort 3a)|All participants administered asenapine with evaluable pharmacokinetic data. Two participants in Cohort 3a and one participant in Cohort 3c did not complete the study and are excluded from pharmacokinetic analysis.||hr*ng/mL||Standard Deviation|Mean
827438|NCT01206517|Primary|Time to Maximum Plasma Concentration (Tmax) of Asenapine|tmax is the time from dosing to maximum plasma drug concentration levels.|Predose (0 hours) and 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 36 and 48 hours after the final asenapine dose (administered on Day 7 for Cohorts 1 and 2; on Day 8 for Cohorts 3b, 3c and 3d; and on Day 12 for Cohort 3a)|All participants administered asenapine with evaluable pharmacokinetic data. Two participants in Cohort 3a and one participant in Cohort 3c did not complete the study and are excluded from pharmacokinetic analysis.||hr||Full Range|Median
827439|NCT01206517|Primary|Maximum Plasma Concentration (Cmax) of Asenapine|Cmax is the peak plasma concentration following a dose of the study drug.|Predose (0 hours) and 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 36 and 48 hours after the final asenapine dose (administered on Day 7 for Cohorts 1 and 2; on Day 8 for Cohorts 3b, 3c and 3d; and on Day 12 for Cohort 3a)|All participants administered asenapine with evaluable pharmacokinetic data. Two participants in Cohort 3a and one participant in Cohort 3c did not complete the study and are excluded from pharmacokinetic analysis.||ng/mL||Standard Deviation|Mean
827440|NCT01206582|Secondary|Leukocyte and Platelet Counts|Measured by complete blood count|baseline, Day 4, Day 7, Day 56|||number x 10^9 cells/L||Standard Error|Mean
827441|NCT01206582|Secondary|Erythrocyte Count|Measured by complete blood count|baseline, Day 4, Day 7, Day 56|||number x 10^12 erythrocytes/L||Standard Error|Mean
827442|NCT01206582|Secondary|Hemoglobin|Measured by complete blood count|baseline, Day 4, Day 7, Day 56|||g/dL||Standard Error|Mean
827443|NCT01206582|Secondary|Activated Partial Thromboplastin Time (APTT)||baseline, Day 4, Day 7, Day 56|||Seconds||Standard Error|Mean
827444|NCT01206582|Secondary|Prothrombin Time||baseline, Day 4, Day 7, Day 56|||International Normalized Ratio (INR)||Standard Error|Mean
827445|NCT01206582|Secondary|Serum Creatinine||baseline, Day 4, Day 7, Day 56|||mg/dL||Standard Error|Mean
827446|NCT01206582|Secondary|Autonomic Functions|Subjects completed a standardized autonomic symptom questionnaire, the Composite Autonomic Severity Score (CASS) which consists of 2 subscores: cardiovagal (CASS-vag; 0-3) and adrenergic (CASS-adr;0-3), where 0, 1, 2, 3 represent non, mild, moderate, and severe dysfunction, respectively.|baseline, Day 56|Total number of subjects analyzed varied per time period due to discontinuations, subject and data availability. Subjects analyzed are presented per category as (n=hemin, albumin arms).||units on a scale||Standard Error|Mean
827447|NCT01206582|Secondary|Gastrointestinal Symptoms|Subjects recorded their GI symptoms every day in the validated Gastroparesis Cardinal Symptom Index (GCSI) - Daily Diary. For each subject, the daily GCSI data were averaged per week. Components coded 0 (no symptoms) to 5 (very severe). GCSI total score is the average of 9 components from the nausea/vomiting, fullness/early satiety, and bloating subscores. These individual subscores are averages of 3,4, and 2 components, respectively. Subscores for upper and lower abdominal pain, heartburn/regurgitation and FDA nausea, vomiting, fullness, and pain (NVFP) composite are averages of 2, 2, 7, and 4 components, respectively.|baseline, 8 weeks|Total number of subjects analyzed varied per time period due to discontinuations, subject and data availability. Subjects analyzed are presented per category as (n=hemin, albumin arms).||units on a scale||Standard Error|Mean
827448|NCT01206582|Primary|Gastric Emptying Half-time|The time for half of the ingested solids or liquids to leave the stomach. Gastric emptying was assessed with ^13C Spirulina Breath Test. After an overnight fast, subjects consumed the test meal containing ^13C Spirulina. Breath samples were collected in duplicate glass tube using a straw to blow into the bottom of the tube to displace contained air. The ^13CO_2 content of the breath was determined by AB Diagnostics. The provide of ^13CO_2 excretion is used to estimate the half-time of gastric emptying.|baseline, day 3, day 7, day 56|Total number of subjects analyzed varied per time period due to discontinuations, subject and data availability. Subjects analyzed are presented per category as (n=hemin, albumin arms).||minutes||Standard Error|Mean
827454|NCT01206608|Primary|Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) at Rest (NRS-R) and With Activity (NRS-A) Pain Intensity Scores|Assessments of postoperative pain were conducted through 96 hours and included pain intensity at rest (NRS-R) and with activity (NRS-A). The prescribed activity was to consist of raising the arm, in full extension at the elbow and wrist, to a position parallel with the axis of the torso. Pain intensity was scored on an 11-point scale, where 0 = no pain and 10 = worst possible pain.|Through 96 hours postdose|||Units on a scale*hours||Standard Deviation|Mean
827455|NCT01206660|Secondary|Physician’s Global Assessment (PGA) of Psoriasis Score at Day 28.|Physician Global Assessment (PGA) of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of face, genitals, or intertriginous area (i.e., breast fold, gluteal crease, axilla). Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease.|Day 28|ITT Population. Participants who returned for at least one post baseline visit and/or provided an assessment for pruritus were evaluated; not all participants returned for every study visit.||units on a scale||Standard Deviation|Mean
827456|NCT01206660|Primary|Treatment Success|A patient is considered a Treatment Success for the Target Lesions if the target lesion has a score of 0 or 1 on the Target Lesion Severity Score (TLSS) for each the three signs and symptoms (erythema, scaling and plaque elevation).|Day 28|||participants|||Number
827457|NCT01206660|Primary|Clinical Success ITT|A patient is considered a Clinical Success if the Physician's Global Assessment (PGA) is 0 (clear) or 1 (almost clear).|28 days|Analysis was conducted using Intent-to-Treat (ITT)||participants|||Number
827458|NCT01206738|Primary|Email vs Postal Recruitment: Number of GPs Completing the First Questionnaire|GPs were randomly allocated to receive their invitation to take part by email or by post. Outcome measure was proportion of GPs responding by completing the first questionnaire|27/1/20111 - 15/5/2011|880 physicians received email and 880 received postal invitations. 138 and 132 responded respectively.||participants|||Number
827459|NCT01206738|Primary|Number of Simulated Scenarios Where an Antibiotic Was Not Prescribed|Eight simulated clinical scenarios where presented to the GP and he/she was asked whether an antibiotic should be prescribed. The outcome measures was the number of scenarios where an antibiotic was not prescribed.|Immediately after completion of questionnaire|||scenarios||Standard Deviation|Mean
827460|NCT01206777|Secondary|Demonstrate Nursing Satisfaction for Administration of Rapid Infusion Over Standard Titration Practice|Surveys were given to nurses in the outpatient infusion center to measure their satisfaction with the administration of the rapid infusion rate compared to standard titration practice.|6 months, as a before and after infusion survey|Post infusion surveys were collected and de-identified by assignment of an individual nurse identification number||percentage of nurses satisfied|||Number
827461|NCT01206777|Secondary|Time Savings of a 60 Minute Infusion Versus Predicted Infusion Time Using Standard Second Dose Titration Schedule||Determined from difference in expected time by package insert administration and actual time on day of treatment|||minutes for rapid R infusion||95% Confidence Interval|Mean
827462|NCT01206777|Primary|Incidence of Grade III and IV Hypersensitivity Reactions||Every 15 minutes from start of infusion until completion, for up to 1 hour|||percentage of patients|||Number
827463|NCT01207102|Secondary|"To Assess the Safety and Tolerability of a Combination Regimen of Weekly Abraxane® and Carboplatin to Treat Women With Triple Negative Stage IV Metastatic Breast Cancer"|The proportion of patients experiencing any neurotoxicity will be tabulated by grade. The proportion of patients experiencing ≥ grade 3 non-hematologic toxicities (excluding neurotoxicity) and the proportion of patients experiencing ≥ grade 3 hematologic toxicities will be calculated with their exact 80% confidence intervals.|2 years|Due to insufficient accrual, data analysis was not performed.|||||
827464|NCT01207102|Primary|PFS|The primary objective of the trial is to statistically test whether Abraxane® and carboplatin can improve progression-free survival (PFS) as compared to historical controls.|PFS is defined as the interval from study registration to disease progression or death due to any cause, whichever comes first|Due to insufficient accrual, data analysis was not performed.|||||
827465|NCT01207219|Secondary|Severity of Symptoms|PANSS total score is computed by summing the scores of positive, negative and general symptom subscores. The range of PANSS total score is from 30 to 210, range of PANSS positive and negative subscores is from 7 to 49, range of PANSS general symptoms subscore is from 16 to 112, with higher values representing worse outcome. CDS total score is computed by summing the scores of nine items of the scale. The range of CDS total score is from 0 to 27, with higher values representing worse outcome.|Baseline and 12 weeks|One subject in the waitlist control group has not completed all measures both at the baseline and 12 weeks. Measure of clinical severity has been missing in the data set. So that there are 37 subjects' data of clinical severity has been included for analysis.||units on a scale||Standard Deviation|Mean
827466|NCT01207219|Primary|Attention and Concentration|measured by Letter Cancellation test Q score. The basic version of the task consists of six 52-character rows in which the target character is randomly interspersed approximately 18 times in each row. Subjects were asked to cancel the letter “C” and “E” as quickly as possible. The time to completion, number of error and omission items were recorded. A “quality of search” index (Q), developed by Geldmacher et al., was applied for the analysis. Q is the ratio of correct number to total number of targets multiplied by the ratio of correct number per second. Higher Q scores represent more efficient performance and better attention and concentration. Q scores could range from 0 (worst possible outcome) to 1 (best possible outcome).|baseline and 12 weeks|||Correct number per second||Standard Deviation|Mean
827467|NCT01207219|Primary|Working Memory|measured by Digit Span backwards test. In this test, the subject was asked to recall a series of numbers in reverse order. The correctly recalled series were scored as 1, and the test contains 14 sequences of numbers. The range of working memory score is from 0 to 14, with higher values representing better outcome.|baseline and 12 weeks|||Scores on a scale||Standard Deviation|Mean
827468|NCT01207219|Primary|Verbal Retention|The total number of correctly recalled words after short-term (10 minutes) and long-term (30 minutes) delay in the random condition of Hong Kong List Learning test.|baseline and 12 weeks|||correctly recorded words||Standard Deviation|Mean
827469|NCT01207219|Primary|Verbal Acquisition|Total number of corrected encoded words in the first three trials in the random condition of Hong Kong List Learning test.|baseline and 12 weeks|||correctly encoded words||Standard Deviation|Mean
827470|NCT01207388|Secondary|Resource Utilization||5 years||01/2020||||
827471|NCT01207388|Secondary|Change From Baseline in EuroQoL 5-Dimension (EQ-5D) Scales|The EQ-5D is a self-administered questionnaire which captures 3 basic types of information: a descriptive profile (health state index) and the overall health rating using a visual analog scale. The health state index measures mobility, self-care, usual activities, pain/discomfort and anxiety/depression on scales from no problems (score = 1), some problems (score = 2), to extreme problems (score = 3). For each dimension the mean change from baseline was calculated at the end of each treatment cycle and at the end of study. The maximum observed change from baseline during cycles 1 to 4 and the change from baseline at the end of study are reported for each dimension.|Subjects are assessed at Screening Visit (Baseline), at day 29 of each treatment cycle, at Day 30 Safety Follow-Up Visit and during mandated Efficacy Follow-Up Visits occurring at month 3, 6, 9, 12, 18 and 24 after treatment start.|Full analysis set||units on a scale||Standard Error|Mean
827472|NCT01207388|Secondary|Change From Baseline in EORTC-QLQ-C30 Scales|"The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Insomnia, Appetite Loss, Constipation, Diarrhea, Financial Impact).
For each of these scales, scores range from 0 to 100. For the GHS and 5 functional scales a high score indicates better global health status/functioning and a positive change from baseline indicates improvement. For the 9 symptom scales, a high score indicates a higher level of symptoms, and a negative change from Baseline indicates an improvement in symptoms.
The maximum changes from baseline to cycles 1 through 4 and to the end of the core study are reported."|Subjects are assessed at Screening Visit (Baseline), at day 29 of each treatment cycle, at Day 30 Safety Follow-Up Visit and during mandated Efficacy Follow-Up Visits occurring at month 3, 6, 9, 12, 18 and 24 after treatment start.|Full analysis set||units on a scale||Standard Error|Mean
827473|NCT01207388|Secondary|Number of Participants With Adverse Events|"Adverse events (AEs) were evaluated for severity according to the the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4, as follows:
Grade 1 – Mild AE; Grade 2 – Moderate AE; Grade 3 - Severe AE; Grade 4 - Life-threatening or disabling AE; Grade 5 - Death.
The investigator used medical judgment to determine if there was a causal relationship (ie, related, unrelated) between an adverse event and blinatumomab.
An AE was considered “serious” if it resulted in death, was life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant incapacity or substantial disruption to conduct normal life functions, was a congenital anomaly or birth defect or was a medically important condition."|From the first dose of blinatumomab until 30 days after last dose. Adverse events are reported up to the data cut-off date of 05 August 2015; the median treatment duration was 55 days.|All participants who received any infusion of blinatumomab.||participants|||Number
827474|NCT01207388|Secondary|Change in MRD Level From Baseline to End of Cycle 1 in Non-MRD Responders|MRD level was measured by polymerase chain reaction (PCR) performed on bone marrow and assessed by the central laboratory. An MRD level of 10^-n corresponds to residual leukemia cells at a frequency of 1 per 10ⁿ bone marrow cells.|Baseline and end of cycle 1 (6 weeks)|Full analysis set participants who were in hematological complete remission at treatment start, with no MRD Response in the first treatment cycle, excluding Philadelphia-positive participants.||participants|||Number
827475|NCT01207388|Secondary|Duration of Complete MRD Response|"The duration of MRD response was analyzed as the time from onset of MRD negativity until MRD or hematological relapse or date of last confirmation of negative MRD status. Participants who received chemotherapy or HSCT after treatment with blinatumomab, before hematological or extramedullary relapse were censored at the start of chemotherapy or HSCT, respectively.
MRD relapse is defined as the reappearance of individual rearrangements of Ig- or TCR-genes ≥ lower limit of quantification (LLOQ) for at least 1 individual marker measured by an assay with a sensitivity of minimum 10^-4. Hematological relapse is defined as the unequivocal detection of > 5% leukemia cells in bone marrow as measured by cytological or microscopic assessment, presence of circulating leukemia blasts, or extramedullary leukemia."|Until the data cut-off date of 05 August 2015; median time on study was 18.3 months.|Full analysis set participants who were in hematological complete remission at treatment start, excluding Philadelphia-positive participants, who had an MRD complete response at cycle 1||months||95% Confidence Interval|Median
827476|NCT01207388|Secondary|Time to Hematological Relapse|Time to hematological relapse was measured from the start of treatment with blinatumomab until hematological or extramedullary relapse. Participants who died or received HSCT or post-blinatumomab chemotherapy after treatment with blinatumomab were censored at their last hematological assessment prior to death or HSCT or post-blinatumomab chemotherapy (whichever occurred first).|Until the data cut-off date of 05 August 2015; median time on study was 18.3 months.|Full analysis set participants who were in hematological complete remission at treatment start, excluding Philadelphia-positive participants.||months||95% Confidence Interval|Median
827477|NCT01207388|Secondary|100-Day Mortality After Allogeneic Hematopoietic Stem Cell Transplant|The mortality rate within 100 days after allogeneic HSCT was defined as the Kaplan-Meier estimate of the percentage of participants dying within 100 days after the day of the first allogeneic HSCT.|100 days after HSCT, as of the data cut-off date of 05 August 2015|Full analysis set participants who underwent HSCT prior to relapse (hematological or extramedullary) excluding Philadelphia-positive participants||percentage of participants||95% Confidence Interval|Number
827478|NCT01207388|Secondary|Overall Survival|Overall survival was measured from the first treatment with blinatumomab until death due to any cause. Participants who did not die were censored at their last contact date.|Until the data cut-off date of 05 August 2015; median time on study was 18.3 months.|Full analysis set||months||95% Confidence Interval|Median
827487|NCT01207414|Primary|Integrated Clinical Global Impression of Change (I-CGI-C) at Week 12|The I-CGI-C at Week 12 was the overall impression of medically qualified raters using three separate Clinical Global Impression of Change scales: efficacy (E-CGI-C); safety and tolerability (ST-CGI-S); and overall severity (I-CGI-S) combined for a total score. The I-CGI-C scale ranged from 1 to 7 with lower scores indicating improvement (1=very much improved, 2=much improved, 3=minimally improved), higher scores indicating worsening (5=minimally worse, 6= much worse, 7=very much worse), and a score of 4 indicating no change.|Week 12|Participants from the Full Analysis Set (three cohorts combined: risperidone, olanzapine or aripiprazole) with data available for analyses.||Score on a scale||Standard Deviation|Mean
827479|NCT01207388|Secondary|Hematological Relapse-free Survival (RFS)|"Hematological RFS was measured from first dose of blinatumomab until the first assessment of documented relapse (either hematological or extramedullary), secondary leukemia, or death due to any cause. Participants without a documented relapse, or death due to any cause were censored at the time of their last hematological assessment. Participants who received chemotherapy for relapsed or persistent MRD or for any other reason after treatment with blinatumomab, or HSCT after treatment with blinatumomab, before hematological or extramedullary relapse, or death occurred were censored at the start of chemotherapy or HSCT, respectively.
Hematological relapse was defined as unequivocal detection of > 5% leukemia cells in bone marrow as measured by cytological, microscopic assessment, presence of circulating leukemia blasts, or extramedullary leukemia (whichever occurred first).
The 18-month Kaplan-Meier estimate of hematological RFS is reported."|18 months|Full analysis set participants who were in hematological complete remission at treatment start, excluding Philadelphia-positive participants.||percentage of participants||95% Confidence Interval|Number
827480|NCT01207388|Primary|Percentage of Participants With a Minimal Residual Disease (MRD) Response Within the First Treatment Cycle|"At the end of the first treatment cycle (Day 29) a bone marrow aspiration/biopsy was performed and evaluated by the central MRD laboratory.
Complete MRD response is defined as no polymerase chain reaction (PCR) amplification of individual rearrangements of immunoglobulin (Ig)- or T-cell receptor (TCR)-genes detected after completion of the first cycle."|During the first cycle (6 weeks)|Primary endpoint full analysis set (Prim EP FAS) included all participants with an Ig TCR PCR MRD assay with the minimum required sensitivity of 1 x 10^-4 at central lab established at Baseline.||percentage of participants||95% Confidence Interval|Number
827481|NCT01207401|Primary|Median Visual Analogue Score Measuring Pain|"We asked participants to report their pain score on visual analogue scale (0mm=no pain and 100mm=worse pain possible) at the following time points:
Speculum placement
Tenaculum placement
Paracervical block administration(if subject is in this arm)
IUD insertion
Five minutes post procedure"|1) Speculum placement 2) Tenaculum placement 3) Paracervical block administration(if subject is in this arm) 4) IUD insertion 5) Five minutes post procedure|||units on a scale||Full Range|Median
827482|NCT01207414|Secondary|Change From Baseline in Integrated Clinical Global Impression of Severity (I-CGI-S) at Week 12|I-CGI-S incorporated the overall, combined impression of illness severity based upon the E-CGI-S and ST-CGI-S. Medically qualified raters evaluated the patient's illness in the previous 7 days at Baseline and Week 12 on a scale of 1 to 7 (1=normal not at all ill, 2=borderline mental illness or impairment, 3=mildly ill or impaired, 4=moderately ill or impaired, 5=marked ill or impaired, 6= severely ill or impaired or 7=among the most extremely ill patients. A negative change from baseline indicates improvement.|Baseline, Week 12|||Score on a scale||Standard Deviation|Mean
827483|NCT01207414|Secondary|Change From Baseline in the Safety and Tolerability Clinical Global Impression of Severity (ST-CGI-S) at Week 12|Medically qualified raters used the ST-CGI-S at Baseline and Week 12 to evaluate safety and tolerability in the previous 7 days on a scale of 1 to 7 (1=Normal-no symptoms, 2=borderline severity, 3=mild impairment, 4=moderate, 5=marked, 6=severe, 7=among the most severe.) A negative change from baseline indicates improvement.|Baseline, Week 12|Participants from the Full Analysis Set with data available for analyses.||Score on a scale||Standard Deviation|Mean
827484|NCT01207414|Secondary|Change From Baseline in the Efficacy Clinical Global Impression of Severity (E-CGI-S) at Week 12|Medically qualified raters use the E-CGI-S scale at Baseline and Week 12 to assess the effectiveness of treatment by examining changes in positive symptoms [hallucinations (false perceptions), delusions (false beliefs), paranoia (unfounded distrust), conceptual disorganization (loosening of associations), or hostility], negative symptoms [apathy (lack of interest), avolition (lack of motivation), alogia (poverty of speech), and anhedonia (absence of pleasure)] and cognitive symptoms [concentration difficulties, difficulties with executive function (integrative reasoning), and illogical thinking] in the previous 7 days on a scale of 1 to 7 (1=normal, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill or 7=among the most extremely ill). A negative change from baseline indicates improvement.|Baseline, Week 12|Participants from the Full Analysis Set with data available for analyses.||Score on a scale||Standard Deviation|Mean
827485|NCT01207414|Secondary|Number of Participants With Adverse Events, Serious Adverse Events or Death|"Adverse event are defined as any unfavorable and unintended diagnosis, symptoms, sign (including an abnormal lab finding), syndrome or disease which either occurs during the study, having been absent at baseline, or if present at baseline appear to worsen.
Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization , cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgments of the investigators represent significant hazards.
Additional information about adverse events can be found in the Adverse Event section."|12 Weeks|Participants from the Safety Analysis Set- all randomized participants who received study drug (three cohorts combined: risperidone, olanzapine or aripiprazole) with data available for analyses.||Participants|||Number
827486|NCT01207414|Secondary|Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) at Week 12|The TSQM consisted of 14 questions about the patient's satisfaction with the drug in 4 domains: Effectiveness [3 questions scored as 1(extremely dissatisfied) to 7(extremely satisfied)], Side Effects [question 4 scored as 0(no) or 1(yes);question 5 scored as 1(extremely bothersome) to 5(not at all bothersome);questions 6 - 8 scored as 1(a great deal) to 5(not at all)], Convenience [questions 9 and 10 scored as 1(extremely difficult) to 7 (extremely easy);question 11 scored as 1(extremely inconvenient) to 5 (extremely convenient)] and Global Satisfaction [question 12 scored as 1(not at all confident) to 7(extremely confident);question 13 scored as 1(not at all certain) to 5(extremely certain);question 14 scored as 1(extremely dissatisfied) to 5(extremely satisfied)]. The scores of each of the domains were added together and an algorithm used to create a score of 0 to 100. Higher scores for each domain indicate a better outcome. A positive change from baseline indicates improvement.|Baseline, Week 12|Participants from the Full Analysis Set with data available for analyses.||Score on a scale||Standard Deviation|Mean
827501|NCT01207570|Primary|Ankle Passive Range of Motion|Ankle dorsiflexion passive range of motion|Day 1 after treatment|All subjects received the intended treatment protocol and were included in the analysis. ITT was used to analyze the data.||degree||Standard Deviation|Mean
828225|NCT01215279|Secondary|CCL2 (Chemokine Ligand for CCR2b Receptor) Concentration in Plasma at Baseline|Baseline = Day 1 = Visit 2|Day 1|||pg/mL||Full Range|Geometric Mean
827488|NCT01207427|Primary|Change From Baseline in the Weekly Average of Spontaneous Bowel Movements (SBMs) During Treatment|An SBM was defined as a bowel movement (BM) with no laxative use in the previous 24 hours. Each weekly SBM average was calculated as follows: (7 × number of SBMs) / (number of days with nonmissing data). The overall SBM rate for the 4-week double-blind treatment period was calculated as follows: (the average of the first week + the average of the second week + the average of the third week + the average of the fourth week) / 4.|Baseline, Weeks 1 through 4 of treatment|All participants who were randomized to study treatment and had at least 1 evaluable SBM post-dose measurement during the Double-blind Period. Last-observation-carried-forward (LOCF) was used to impute missing postbaseline values.||Number of SBMs/week||Standard Error|Mean
827489|NCT01207453|Secondary|Knee Pain Threshold|A measure of the change in knee pain threshold from baseline to 6 weeks. Knee pain threshold was determined by applying pressure to a subject's knee until the subject felt pain. The difference between the average knee pain threshold (an average for the right and left knees) at baseline was compared to that at 6 months. Pain threshold was measured in kg/cm^2. The difference in threshold could range from 0-11 kg/cm^2. A higher difference between thresholds indicates improved pain sensitivity.|Baseline to 6 weeks|||kg/cm^2||Standard Deviation|Mean
827490|NCT01207453|Secondary|Wrist Pain Threshold|A measure of the change in wrist pain threshold from baseline to 6 weeks. Wrist pain threshold was determined by applying pressure to a subject's wrist until the subject felt pain. The difference between the average wrist pain threshold (an average for the right and left wrists) at baseline was compared to that at 6 months. Pain threshold was measured in kg/cm^2. The difference in threshold could range from 0-11 kg/cm^2. A higher difference between thresholds indicates improved pain sensitivity.|Baseline to 6 weeks|||kg/cm^2||Standard Deviation|Mean
827491|NCT01207453|Secondary|Trapezius Pain Threshold|A measure of the change in trapezius pain threshold from baseline to 6 weeks. Trapezius pain threshold was determined by applying pressure to a subject's trapezius muscle until the subject felt pain. The difference between the average trapezius pain threshold (an average for the right and left trapezii) at baseline was compared to that at 6 months. Pain threshold was measured in kg/cm^2. The difference in threshold could range from 0-11 kg/cm^2. A higher difference between thresholds indicates improved pain sensitivity.|Baseline to 6 weeks|||kg/cm^2||Standard Deviation|Mean
827492|NCT01207453|Secondary|Thumbnail Pain Threshold|A measure of the change in thumbnail pain threshold from baseline to 6 weeks. Thumbnail pain threshold was determined by applying pressure to a subjectt's thumbnail until the subject felt pain. The difference between the average thumbnail pain threshold (an average for the right and left thumbs) at baseline was compared to that at 6 months. Pain threshold was measured in kg/cm^2. The difference in threshold could range from 0-11 kg/cm^2. A higher difference between thresholds indicates improved pain sensitivity.|Baseline to 6 weeks|||kg/cm^2||Standard Deviation|Mean
827493|NCT01207453|Secondary|Symptom Intensity Scale (SIS)|A measure of the change in SIS score from baseline to 6 weeks. The SIS score ranges from 0-9.75, with high scores being worse indicating more widespread pain and fatigue.|Baseline to 6 weeks|||units on a scale||Standard Deviation|Mean
827494|NCT01207453|Secondary|Change in Conditioned Pain Modulation (CPM)|CPM is defined as the difference between pain threshold A (measured after a conditioning stimulus activates pathways that inhibit pain) and pain threshold B (measured before the conditioning stimulus is applied). The conditioning stimulus was immersion of the hand in a cold water bath. Pressure pain threshold was assessed at the trapezius muscle initially. Subjects were then instructed to immerse their hand in a water bath for 30 seconds. At 20 seconds, pressure pain threshold at the trapezius was assessed again. We defined the magnitude of subjects’ CPM as the difference in pressure pain threshold between baseline and 20 seconds after cold water immersion. This difference was compared to that measured at 6 weeks. The scale for the difference in CPM ranged from 0-11 kg/cm^2, with 0 indicating no change in CPM between 6 weeks and baseline and 11 indicating the maximum possible change. A greater change in CPM between baseline and 6 weeks is indicative of improvements in CPM.|Baseline to 6 weeks|||kg/cm^2||Standard Deviation|Mean
827495|NCT01207453|Primary|Brief Pain Inventory (BPI) Change|"A measure of change in scores on the BPI short form, a 24-hr average pain item, from baseline to 6 weeks, The BPI short form scores ranges from 0-10, with 10 being the worst pain."|Baseline to 6 weeks|||units on a scale||Standard Deviation|Mean
827496|NCT01207466|Primary|Quality of Vision (Crisp and Clear)|Quality of vision (crisp and clear), as interpreted and reported by the participant by eye on a questionnaire as a single, retrospective evaluation of one week’s wear time. Quality of vision was assessed on a 10-point scale, with 1 being poor and 10 being excellent.|1 week of wear|Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses.||units on a scale|Participants|Standard Deviation|Mean
827497|NCT01207492|Secondary|Clinical Benefit Rate|To determine the clinical benefit rate [% CR + % PR + % stable disease by RECIST 1.1] at 6 months. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR) is a disappearance of all target lesions. Partial Response (PR) is a >=30% decrease in the sum of the longest diameter of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|6 months|||percentage of participants||95% Confidence Interval|Number
827498|NCT01207492|Secondary|Overall Tumor Response Rate (OR)|To determine overall tumor response rate [% complete response (CR) + % partial response (PR) by RECIST 1.1]. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR) is a disappearance of all target lesions. Partial Response (PR) is a >=30% decrease in the sum of the longest diameter of target lesions. Overall Response (OR) = CR + PR.|2 years|||percentage of participants||95% Confidence Interval|Number
827499|NCT01207492|Primary|Percentage of Participants With Progression Free Survival|To estimate progression free survival at 6 months in participants with recurrent PVNS treated with nilotinib. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|6 months|||percentage of participants with PFS||95% Confidence Interval|Number
827500|NCT01207570|Primary|Ankle Passive Range of Motion|Ankle passive range of motion on day 4 after the crossover treatment|Day 4 after treatment|||degree||Standard Deviation|Mean
827504|NCT01207583|Secondary|Percentage of Participants With Pre-Specified Systemic Events Post-dose 4|Systemic events (any fever >=38 degrees C, decreased appetite, diarrhea, restless sleep, unusual crying, unusual fussiness, unusual irritability, and vomiting) were reported using an electronic diary. Participants may be represented in more than 1 category.|Day 1 to Day 3 post-dose 4|Safety set (post-dose 4) population included all participants who received Dose 4 and who had safety follow-up data following Dose 4.||Percentage of participants|||Number
827505|NCT01207583|Secondary|Percentage of Participants With Pre-Specified Systemic Events Post-dose 3|Systemic events (any fever >=38 degrees C, decreased appetite, diarrhea, restless sleep, unusual crying, unusual fussiness, unusual irritability, and vomiting) were reported using an electronic diary. Participants may be represented in more than 1 category.|Day 1 to Day 3 post-dose 3|Safety set (post-dose 3) population included all participants who received Dose 3 and who had safety follow-up data following Dose 3.||Percentage of participants|||Number
827506|NCT01207583|Secondary|Percentage of Participants With Pre-Specified Systemic Events Post-dose 2|Systemic events (any fever >=38 degrees C, decreased appetite, diarrhea, restless sleep, unusual crying, unusual fussiness, unusual irritability, and vomiting) were reported using an electronic diary. Participants may be represented in more than 1 category.|Day 1 to Day 3 post-dose 2|Safety set (post-dose 2) population included all participants who received Dose 2 and who had safety follow-up data following Dose 2.||Percentage of participants|||Number
827507|NCT01207583|Secondary|Percentage of Participants With Pre-Specified Systemic Events Post-dose 1|Systemic events (any fever >=38 degrees C, decreased appetite, diarrhea, restless sleep, unusual crying, unusual fussiness, unusual irritability, and vomiting) were reported using an electronic diary. Participants may be represented in more than 1 category.|Day 1 to Day 3 post-dose 1|Safety set (post-dose 1) population included all participants who received Dose 1 and who had safety follow-up data following Dose 1.||Percentage of participants|||Number
827508|NCT01207583|Secondary|Percentage of Participants With Pre-Specified Local Reactions Post-dose 4|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and redness were scaled as Any (induration or redness present); Mild (<2.5 cm); Moderate (>=2.5 cm to <5.0 cm); Severe (>=5.0 cm). Participants may be represented in more than 1 category. Solicited local reactions included redness, swelling and tenderness while unsolicited local reactions included injection site hematoma, injection site hemorrhage, injection site induration and injection site warmth.|Day 1 to Day 3 post-dose 4|Safety set (post-dose 4) population included all participants who received Dose 4 and who had safety follow-up data following Dose 4.||Percentage of participants|||Number
827509|NCT01207583|Secondary|Percentage of Participants With Pre-Specified Local Reactions Post-dose 3|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and redness were scaled as Any (induration or redness present); Mild (<2.5 cm); Moderate (>=2.5 cm to <5.0 cm); Severe (>=5.0 cm). Participants may be represented in more than 1 category. Solicited local reactions included redness, swelling and tenderness while unsolicited local reactions included injection site hematoma, injection site hemorrhage, injection site induration and injection site warmth.|Day 1 to Day 3 post-dose 3|Safety set (post-dose 3) population included all participants who received Dose 3 and who had safety follow-up data following Dose 3.||Percentage of participants|||Number
827510|NCT01207583|Secondary|Percentage of Participants With Pre-Specified Local Reactions Post-dose 2|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and redness were scaled as Any (induration or redness present); Mild (<2.5 cm); Moderate (>=2.5 cm to <5.0 cm); Severe (>=5.0 cm). Participants may be represented in more than 1 category. Solicited local reactions included redness, swelling and tenderness while unsolicited local reactions included injection site hematoma, injection site hemorrhage, injection site induration and injection site warmth.|Day 1 to Day 3 post-dose 2|Safety set (post-dose 2) population included all participants who received Dose 2 and who had safety follow-up data following Dose 2.||Percentage of participants|||Number
827511|NCT01207583|Secondary|Percentage of Participants With Pre-Specified Local Reactions Post-dose 1|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and redness were scaled as Any (induration or redness present); Mild (<2.5 centimeters [cm]); Moderate (>=2.5 cm to <5.0 cm); Severe (>=5.0 cm). Participants may be represented in more than 1 category. Solicited local reactions included redness, swelling and tenderness while unsolicited local reactions included injection site hematoma, injection site hemorrhage, injection site induration and injection site warmth.|Day 1 to Day 3 post-dose 1|Safety set (post-dose 1) population included all participants who received Dose 1 and who had safety follow-up data following Dose 1.||Percentage of participants|||Number
827512|NCT01207583|Primary|Percentage of Participants With Febrile Reactions Post-dose 4|Febrile reactions were defined as reactions which causes a rise in body temperature following vaccination in children. Fever was defined as a temperature of >=38 degrees C. Percentage of participants with febrile reaction of >=38 degrees C was observed.|Day 1 to Day 3 post-dose 4|Safety set (post-dose 4) population included all participants who received Dose 4 and who had safety follow-up data following Dose 4.||Percentage of participants||95% Confidence Interval|Number
827513|NCT01207583|Primary|Percentage of Participants With Febrile Reactions Post-dose 3|Febrile reactions were defined as reactions which causes a rise in body temperature following vaccination in children. Fever was defined as a temperature of >=38 degrees C. Percentage of participants with febrile reaction of >=38 degrees C to <=39 degrees C was observed.|Day 1 to Day 3 post-dose 3|Safety set (post-dose 3) population included all participants who received Dose 3 and who had safety follow-up data following Dose 3.||Percentage of participants||95% Confidence Interval|Number
827514|NCT01207583|Primary|Percentage of Participants With Febrile Reactions Post-dose 2|Febrile reactions were defined as reactions which causes a rise in body temperature following vaccination in children. Fever was defined as a temperature of >=38 degrees C. Percentage of participants with febrile reaction of >=38 degrees C to <=39 degrees C was observed.|Day 1 to Day 3 post-dose 2|Safety set (post-dose 2) population included all participants who received Dose 2 and who had safety follow-up data following Dose 2.||Percentage of participants||95% Confidence Interval|Number
836870|NCT01301079|Primary|Pain 6 Hours|The scale measure pain after 6 hours (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10.|6 hours|||units on a scale||Standard Deviation|Mean
827515|NCT01207583|Primary|Percentage of Participants With Febrile Reactions Post-dose 1|Febrile reactions were defined as reactions which causes a rise in body temperature following vaccination in children. Fever was defined as a temperature of greater than or equal to (>=) 38 degrees Celsius (C). Percentage of participants with febrile reaction of >=38 degrees C to less than or equal to (<=) 39 degrees C, >39 degrees C to <=40 degrees C and >40 degrees C were observed.|Day 1 to Day 3 post-dose 1|Safety set (post-dose 1) population included all participants who received Dose 1 and who had safety follow-up data following Dose 1.||Percentage of participants||95% Confidence Interval|Number
827516|NCT01207596|Secondary|Global Assessment of Treatment Satisfaction|Patients were asked to rate their global assessment of treatment satisfaction, ranging from “very dissatisfied” to “very satisfied”. Adverse events were monitored throughout the study|Baseline visit to Week 12 or last visit|LOCF||percentage of patients|||Number
827517|NCT01207596|Secondary|Pain Quality Assessment Scale (PQAS)|The PQAS is a 20-item scale that quantifies the quality and intensity of neuropathic and non-neuropathic pain; scores range from 1 to 200, with higher scores indicating more severe pain|Baseline visit to 12 weeks visit|LOCF||units on a scale||Standard Error|Mean
827518|NCT01207596|Secondary|Sleep Quality Assessment (SQA)|Sleep Quality Assessment (SQA) scale, asking patients to assess the degree that pain has interfered with their sleep in the last 24 hours (where 0 = does not interfere and 10 = completely interferes)|Baseline visit to Week 12 or last visit|LOCF||units on a scale||Standard Deviation|Mean
827519|NCT01207596|Secondary|Change From Baseline in the Average Pain Over the Last 24 Hrs on the Brief Pain Inventory (BPI) Scale Question #6: the Number That Tells How Much Pain You Have Right Now|"Change from baseline to end of study on question #4 (current pain) of the Brief Pain Inventory (BPI): Please rate your pain by marking the box beside the number that tells how much pain you have right now, where 0 = no pain and 10 = pain as bad as you can imagine."|Baseline visit to Week 12 or last visit|LOCF||units on a scale||Standard Error|Mean
827520|NCT01207596|Secondary|Change From Baseline in the Average Pain Over the Last 24 Hrs on the Brief Pain Inventory (BPI) Scale Question #4: the Number That Best Describes Your Pain at Its Least in the Last 24 Hours|"Change from baseline to end of study on question #4 (least pain) of the Brief Pain Inventory (BPI): Please rate your pain by marking the box beside the number that best describes your pain at its least in the last 24 hours, where 0 = no pain and 10 = pain as bad as you can imagine."|Baseline visit to Week 12 or last visit|LOCF||units on a scale||Standard Deviation|Mean
827521|NCT01207596|Secondary|Change From Baseline in the Average Pain Over the Last 24 Hrs on the Brief Pain Inventory (BPI) Scale Question #3: the Number That Best Describes Your Pain at Its Worst in the Last 24 Hours|"Change from baseline to end of study on question #3 (worst pain) of the Brief Pain Inventory (BPI): Please rate your pain by marking the box beside the number that best describes your pain at its worst in the last 24 hours, where 0 = no pain and 10 = pain as bad as you can imagine."|Baseline visit to Week 12 or last visit|LOCF||units on a scale||Standard Deviation|Mean
827522|NCT01207596|Primary|Change From Baseline in the Average Pain Over the Last 24 Hrs on the Brief Pain Inventory (BPI) Scale|The primary efficacy measure was the change from baseline to end of study on question #5 (“average pain”) of the Brief Pain Inventory (BPI): “Please rate your pain by marking the box beside the number that best describes your pain on the average,” where 0 = no pain and 10 = pain as bad as you can imagine.|Baseline visit to Week 12 or last visit|LOCF||units on a scale||Standard Error|Mean
827523|NCT01207648|Secondary|Time to First Medically Confirmed Clinical Relapse Post-Rebif® Initiation|Medically confirmed clinical relapses were defined as the emergence of new neurological symptoms that occurred more than 30 days after a previous attack and persisted for more than or equal to 24 hours in the absence of known inter-current illness.|Start of observation period (first medical record available on site) up to last medical record available on site or the end of the observation period (31 December 2009), whichever occurred first.|Multiple sclerosis (MS) analysis set is a subset of the “Retrospective Cohort” set included all participants with a final diagnosis of MS. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.||Months||95% Confidence Interval|Median
827524|NCT01207648|Secondary|Annualized Medically Confirmed Clinical Relapses Rate Prior to Rebif® Initiation and During Rebif® Treatment|Medically confirmed clinical relapses were defined as the emergence of new neurological symptoms that occurred more than 30 days after a previous attack and persisted for more than or equal to 24 hours in the absence of known inter-current illness. Annualized relapse rate was defined as number of attacks per year.|Start of observation period (first medical record available on site) up to last medical record available on site or the end of the observation period (31 December 2009), whichever occurred first.|Multiple sclerosis (MS) analysis set is a subset of the “Retrospective Cohort” set included all participants with a final diagnosis of MS. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.||Attacks per year|||Number
827525|NCT01207648|Primary|Number of Participants With Abnormal Laboratory Parameters|Laboratory parameters assessed for abnormality were: total white blood cell count (Neutrophils, Lymphocytes, Leukocytes, Monocytes, Eosinophils and Basophils), differential hematogram (Hematocrit, Erythrocytes, Hemoglobin, and Platelet), aspartate aminotransferase (AST), alanine aminotransferase (ALT), and thyroid tests (including Triiodothyronine, Thyroxine, Thyroperoxidase Antibody and Thyroid-Stimulating Hormone). Due to the retrospective nature of the study, laboratory data should be interpreted with caution as data were not collected according to a specific time schedule and the time on study per participant was not standardized.|Start of observation period (first medical record available on site) up to last medical record available on site or the end of the observation period (31 December 2009), whichever occurred first.|Total analysis set included all the participants who were exposed to Rebif® for treatment of demyelinating event and were evaluated in this retrospective study. 'n' signifies number of participants who were evaluable for the specified categories.||Participants|||Number
827615|NCT01200797|Primary|Overall Survival (OS)|Estimated probable duration of life from on‐study date to date of death from any cause, using the Kaplan‐Meier method with censoring (see analysis population description for additional details).|On‐study date to date of death from any cause (assessed up to 12 months)|All patients are included in the analysis on intention‐to treat basis. Analysis is by Kaplan‐Meier method, where death is an event, with censoring for non‐expired patients at greater of off‐study date or last known alive date.||daya||95% Confidence Interval|Median
827526|NCT01207648|Primary|Number of Participants With Serious Medical Events, and Non-serious Medical Events (Reported by the Investigator as Related to Rebif®)|Medical events in the retrospective study are equivalent to adverse events in a prospective clinical study. A medical event was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered. Serious medical event: A medical event that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition. Participants may be represented in more than one category as participant who had experienced serious medical event may also had experienced non-serious medical event reported by the Investigator as related to Rebif®, so in that case it will be counted in both the categories.|Start of observation period (first medical record available on site) up to last medical record available on site or the end of the observation period (31 December 2009), whichever occurred first.|Total analysis set included all the participants who were exposed to Rebif® for treatment of demyelinating event and were evaluated in this retrospective study.||Participants|||Number
827527|NCT01207648|Primary|Number of Participants With Pre-specified Medical Events|These pre-specified medical events categories were evaluated: injections site reactions, flu-like symptoms, hepatic disorders, blood cell disorders, allergic reactions, epilepsy and convulsive disorders, thyroid dysfunction, autoimmune diseases, bone/epiphyseal and cartilage disorders, serious infections, malignancies. Each category defined by group of events which best fit the medical concept either using a standard medical dictionary for regulatory activities (MedDRA) Query (SMQ) e.g., Malignancies was defined by the SMQ Malignancies (narrow scope) containing more than 1800 different preferred terms (PTs) (including procedures and lab tests) or using a customized query, e.g., Serious infections was defined by all PTs assessed as serious in System Organ Class (SOC) Infections and Infestation. Participants may be represented in more than once in a category (Participants could have reported several medicals events pertaining to a specific category) as well as in more than one category.|Start of observation period (first medical record available on site) up to last medical record available on site or the end of the observation period (31 December 2009), whichever occurred first.|Total analysis set included all the participants who were exposed to Rebif® for treatment of demyelinating event and were evaluated in this retrospective study.||Participants|||Number
827528|NCT01207687|Secondary|Quality of the Life, Assessed Using SF-36, SSQ, andTRQ|Standard scoring manuals will be used to summarize the each item or domains. A overall score at each time point will be compared with the baseline score two-tailed pared t-test will be used to assess the change form the baseline and MANOVA could be used to assess the association between the quality of life and the change of the hearing score. Each item or domain will be summarized using descriptive statistics. Comparisons of on-treatment and post-treatment values with the pre-treatment baseline value will be performed using paired t-tests.|18 months||09/2018||||
827529|NCT01207687|Secondary|Quality of the Life, Assessed Using SF-36, SSQ, andTRQ|Standard scoring manuals will be used to summarize the each item or domains. A overall score at each time point will be compared with the baseline score two-tailed pared t-test will be used to assess the change form the baseline and MANOVA could be used to assess the association between the quality of life and the change of the hearing score. Each item or domain will be summarized using descriptive statistics. Comparisons of on-treatment and post-treatment values with the pre-treatment baseline value will be performed using paired t-tests.|12 months||01/2018||||
827530|NCT01207687|Secondary|Quality of the Life, Assessed Using SF-36, SSQ, andTRQ|Standard scoring manuals will be used to summarize the each item or domains. A overall score at each time point will be compared with the baseline score two-tailed pared t-test will be used to assess the change form the baseline and MANOVA could be used to assess the association between the quality of life and the change of the hearing score. Each item or domain will be summarized using descriptive statistics. Comparisons of on-treatment and post-treatment values with the pre-treatment baseline value will be performed using paired t-tests.|6 months||01/2018||||
827531|NCT01207687|Secondary|Quality of the Life, Assessed Using Health Survey Short Form-36 (SF-36), Speech and Spatial Qualities Questionnaire (SSQ), and Tinnitus Reaction Questionnaire (TRQ)|Standard scoring manuals will be used to summarize the each item or domains. A overall score at each time point will be compared with the baseline score two-tailed pared t-test will be used to assess the change form the baseline and MANOVA could be used to assess the association between the quality of life and the change of the hearing score. Each item or domain will be summarized using descriptive statistics. Comparisons of on-treatment and post-treatment values with the pre-treatment baseline value will be performed using paired t-tests.|Baseline||01/2018||||
827532|NCT01207687|Secondary|Change in Vascular Permeability (Ktrans), Relative Cerebral Blood Volume/Flow, Mean Transit Time, and Mean Vessel Diameter From Perfusion-weighted MRI|The correlations between imaging parameters and hearing response will then be estimated based on the estimated changes. Generalized Estimating Equations (GEE) will be used to estimate association of imaging parameters in hearing responses after treatment. The greatest on-treatment change from the pretreatment baseline value during the course of the study will be computed for each subject. Statistical comparisons between MRI parameters measured on different study time point will be performed with a two-tailed paired exact Wilcoxon test.|Baseline to week 72||01/2018||||
827533|NCT01207687|Secondary|Changes in Function of the Auditory System|The primary DPOAE measurement will be treated non-parametrically (present or absent across time) DPOAE’s will be considered present at the frequency of F2 when the distortion product is 6dB above the noise floor. Variables will be analyzed for differences using t-tests if the effects and sample sizes warrant, but this may not be advisable given the small numbers to be accrued.|Baseline to 6 months post-treatment||01/2018||||
827534|NCT01207687|Secondary|Median Percent Change in Target Vestibular Schwannoma Volume Using Volumetric MRI|The median percent change in the volume of the target vestibular schwannoma using volumetric MRI|Baseline to 12 months|||percentage of change in tumor volume||Full Range|Median
827535|NCT01207687|Secondary|Radiographic Response|The proportion of participants with radiographic response as measured by a >/= 20% reduction in tumor volume from baseline on MRI imaging will be estimated using a binomial distribution.|Baseline to 6 months post-treatment|||participants||95% Confidence Interval|Number
827537|NCT01207687|Primary|Proportion of Patients With Hearing Response|A hearing response was defined as increased word recognition score above the 95% critical threshold that is maintained across two sequential evaluation time points. The word recognition score (WRS) is the percentage of phonetically-balanced, monosyllabic words that a patient can accurately repeat presented at either most comfortable level or most intelligible level.The proportion of patients with hearing response in the target ear was estimated using a binomial distribution along with 95% confidence intervals.|Baseline to 12 months|All people who underwent treatment were analyzed. Two patients stopped treatment early. One due to toxicity at week 25 and one due to need for medical care not permitted while on treatment at week 49.||Proportion with hearing response||95% Confidence Interval|Number
827538|NCT01207765|Secondary|Degree of CD20 Expression on Plasma Cells and/or Targeting of Post-germinal Center B Cells Correlation With Toxicity, Response and Biodistribution|CD20 immunohistochemical staining of plasma cells on baseline bone marrow biopsy specimen, graded on qualitative scale (0 to +++)|2 weeks prior - 2 weeks post transplant|Immunohistochemical analysis showed inconsistent / insufficient CD20 staining on surface of plasma cells; comparisons could not be made|||||
827539|NCT01207765|Secondary|Time to Engraftment in Patients Who Proceed to Myeloablative Chemotherapy After Receiving 90Y Zevalin® (Ibritumomab Tiuxetan).|Number of days from stem cell infusion (day +0) to day of neutrophil engraftment (first of three consecutive days with absolute neutrophil count > 500)|Transplant through day 42|Analyzed on intent-to-treat basis||Days||Full Range|Median
827540|NCT01207765|Primary|Safety and Efficacy|Efficacy: objective response rate (CR + PR) at 12 and 104 days following radioimmunotherapy. Safety: the rate of occurrence of defined toxic events including non-engraftment and unacceptable biodistribution of 90Y Zevalin occurring by day +42 following transplant. Response determined according to Blade' Criteria (Bladé J, Br J Haematol.1998 Sep;102(5):1115-23) for multiple myeloma; Response based on reduction of monoclonal protein (M-protein) from initial presentation.|Through day +104 following immunotherapy|6 subjects had objectively measurable disease and were evaluable for response, 8 subjects received study intervention and are evaluable for safety||participants|||Number
827541|NCT01207934|Secondary|Post-treatment Plasma Leptin Levels|plasma leptin levels after fourteen days ingestion of either leptin or placebo.|fourteen days|||Micrograms/Liter||Standard Error|Mean
827542|NCT01207934|Primary|Post-treatment Glucose Disposal. I.e. Glucose Disposal After Treatment With Leptin or Placebo.|This is a measure of the body's ability to metabolize sugar after treatment with either leptin or a placebo. We compare the effect of leptin therapy on insulin-mediated stimulation of glucose disposal with that of placebo. In general, a high glucose disposal rate is a marker of healthy metabolic function. Glucose disposal is measured by tracking the amount of tagged glucose in the bloodstream over time. It is adjusted to subject body weight.|fourteen days|||mmol/kg body weight/minute||Standard Error|Mean
827543|NCT01207934|Secondary|Baseline Plasma Leptin Concentrations|Leptin is an endogenous hormone. Here we measure the pre-treatment concentration of naturally-occurring leptin in the blood.|baseline|||Micrograms/Liter||Standard Error|Mean
827544|NCT01207934|Primary|Baseline Glucose Disposal - a Measure of the Body's Ability to Process Sugars.|pre-treatment glucose disposal. In general, a high glucose disposal rate is a marker of healthy metabolic function. Glucose disposal is measured by tracking the amount of tagged glucose in the bloodstream over time. It is adjusted to subject body weight.|baseline|||mmol/kg body weight/minute||Standard Error|Mean
827545|NCT01208181|Primary|Percentage of Participants Who Discontinued Study Drug Due to an AE|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.|Up to Week 12|ASaT population defined as all randomized participants who received at least one study drug. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data using the ASaT population.||Percentage of participants|||Number
827546|NCT01208181|Primary|Percentage of Participants Who Experienced at Least One Adverse Event (AE)|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.|Up to 112 days|All Subjects as Treated (ASaT) population, defined as all randomized participants who received at least one study drug. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data using the ASaT population.||Percentage of participants|||Number
827547|NCT01208181|Secondary|Average Change From Week 6 in Patient Global Assessment of Pain Over Weeks 10 and 12 in Part 2 Among Pain Inadequate Responders From Part 1|"A participant overall assessment of pain on a visual analog scale (VAS) was assessed with a question concerning the amount of pain due to arthritis during the past 48 hours. Pain was assessed on an 100 mm VAS scale with a left-hand marker no pain (0 mm) or right-hand marker extreme pain (100 mm). In those participants who were considered inadequate responders to etoricoxib 60 mg in Part 1 (defined as a participant with <50% improvement from baseline in PGAP [VAS] at Week 6), the incremental benefit of increasing the etoricoxib dose from 60 mg (in Part 1) to 90 mg (in Part 2) compared to remaining on 60 mg in Part 2 was evaluated via average change from Week 6 over Weeks 10 and 12 in Patient Global Assessment of Pain score. Therefore, data for only these 2 arms are displayed."|Week 6 and Week 10 to Week 12|This population (a subpopulation of the mITT population) was composed of pain inadequate responder (PIRs) in Part 1. PIRs were defined as participants with <50% improvement from baseline in Patient Global Assessment of Pain (VAS) at Week 6 and received at least one dose of study medication in Part 2.||Scores on a scale||95% Confidence Interval|Least Squares Mean
827556|NCT01208207|Primary|Time-Weighted Average Change From Baseline in the Spinal Pain Intensity in Study Part 1: Etoricoxib 90 mg vs. Naproxen|Spinal Pain Intensity is measured using a visual analog scale (VAS) from 0-100 mm with a lower value representing a better response. The time-weighted average change is calculated by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.|Baseline and up to Week 6|Per-Protocol Population - excluded participants due to important protocol deviations that may have had a substantial effect on the result of the primary efficacy endpoint.||mm VAS||95% Confidence Interval|Least Squares Mean
827557|NCT01208220|Primary|Quicker Filling of the Wound With Good Tissue (vs. Treatment With NPWT Alone)||2 weeks into study|||Percentage of red granulation tissue|||Number
827548|NCT01208181|Secondary|Time-Weighted Average Change From Baseline in Patient Global Assessment of Pain in Part 1 (Etoricoxib 90 mg vs. Etoricoxib 60 mg)|"A participant overall assessment of pain on a visual analog scale (VAS) was assessed with a question concerning the amount of pain due to arthritis during the past 48 hours. Pain was assessed on an 100 mm VAS scale with a left-hand marker no pain (0 mm) or right-hand marker extreme pain (100 mm). The key secondary objectives compared the relative efficacy between etoricoxib 90 mg and 60 mg in Part 1 of this study so data for only these 2 arms are displayed."|Baseline and Week 6|The mITT population in Part 1 consisted of all randomized participants receiving at least 1 dose of study medication, had baseline data for the analysis endpoint, and least one post-randomization measurement for the analysis endpoint that was collected within 3 days after the last dose of study medication.||Scores on a scale||95% Confidence Interval|Least Squares Mean
827549|NCT01208181|Secondary|Time-Weighted Average Change From Baseline in DAS28-CRP in Part 1 (Etoricoxib 90 mg vs. Etoricoxib 60 mg)|Disease Activity Score Using C-Reactive Protein [DAS28-CRP] (0 - 10 Range). The DAS28-CRP index is a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, patient global assessment of disease activity, and C-reactive protein (CRP). For each observation (Baseline, Week 2, 4, 6, 10, 12), components were combined into a single DAS28-CRP score using the following algorithm: 0.56*square root (sqrt) (tender joint count [28])+0.28*sqrt(swollen joint count [28] )+0.36* ln(crp+1) + 0.014* Patient Global Assessment of Disease Activity + 0.96. The key secondary objectives compared the relative efficacy between etoricoxib 90 mg and 60 mg in Part 1 of this study so data for only these 2 arms are displayed.|Baseline and Week 6|The mITT population in Part 1 consisted of all randomized participants receiving at least 1 dose of study medication, had baseline data for the analysis endpoint, and least one post-randomization measurement for the analysis endpoint that was collected within 3 days after the last dose of study medication.||Scores on a scale||95% Confidence Interval|Least Squares Mean
827550|NCT01208181|Primary|Time-Weighted Average Change From Baseline in Patient Global Assessment of Pain in Part 1 (Etoricoxib vs. Placebo)|"A participant overall assessment of pain on a visual analog scale (VAS) was assessed with a question concerning the amount of pain due to arthritis during the past 48 hours. Pain was assessed on an 100 mm VAS scale with a left-hand marker no pain (0 mm) or right-hand marker extreme pain (100 mm). The primary objectives of the study compared the efficacy of etoricoxib (90 mg, 60 mg) to placebo in Part 1 of this study so data for only these 3 arms are displayed."|Baseline and Week 6|The mITT population in Part 1 consisted of all randomized participants receiving at least 1 dose of study medication, had baseline data for the analysis endpoint, and least one post-randomization measurement for the analysis endpoint that was collected within 3 days after the last dose of study medication.||Scores on a scale||95% Confidence Interval|Least Squares Mean
827551|NCT01208181|Primary|Time-Weighted Average Change From Baseline in DAS28-CRP in Part 1 (Etoricoxib vs. Placebo)|Disease Activity Score Using C-Reactive Protein [DAS28-CRP] (0 - 10 Range). The DAS28-CRP index is a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, patient global assessment of disease activity, and C-reactive protein (CRP). For each observation (Baseline, Week 2, 4, 6, 10, 12), components were combined into a single DAS28-CRP score using the following algorithm: 0.56*square root (sqrt) (tender joint count [28])+0.28*sqrt(swollen joint count [28] )+0.36* ln(crp+1) + 0.014* Patient Global Assessment of Disease Activity + 0.96. The primary objectives of the study compared the efficacy of etoricoxib (90 mg, 60 mg) to placebo in Part 1 of this study so data for only these 3 arms are displayed.|Baseline and Week 6|The modified intention-to-treat (mITT) population in Part 1 consisted of all randomized participants receiving at least 1 dose of study medication, had baseline data for the analysis endpoint, and least one post-randomization measurement for the analysis endpoint that was collected within 3 days after the last dose of study medication.||Scores on a scale||95% Confidence Interval|Least Squares Mean
827552|NCT01208207|Primary|Number of Participants Discontinuing Study Treatment Due to an Adverse Event||Up to 26 weeks|All Patients as Treated Population (APaT) - Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to 60 mg in Part II received 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.||Participants|||Number
827553|NCT01208207|Secondary|Average Change From Week 6 in the Spinal Pain Intensity Over Weeks 10 and 12 in Study Part 2: Etoricoxib 60/90 mg vs. Etoricoxib 60mg (Non-responders From Part I)|Spinal Pain Intensity is measured using a visual analog scale (VAS) from 0-100 mm with a lower value representing a better response. Average change from Week 6 in Spinal Pain Intensity (VAS) over Weeks 10 and 12 is calculated as the average Spinal pain Intensity (VAS) value over Weeks 10 and 12 minus the Spinal Pain Intensity (VAS) at Week 6.|Week 6 to Week 10 and Week 12|Modified Intent-to-Treat (mITT) Population - the mITT population in Part I consisted of all randomized participants who received at least 1 dose of study treatment, had at least 1 measurement of interest post-randomization that was collected within 3 days of the last dose of study medication taken in Part I, and had baseline data.||mm VAS||95% Confidence Interval|Least Squares Mean
827554|NCT01208207|Secondary|Time-Weighted Average Change From Baseline in the Spinal Pain Intensity in Study Part 1: Etoricoxib 90 mg vs. Etoricoxib 60 mg|Spinal Pain Intensity is measured using a visual analog scale (VAS) from 0-100 mm with a lower value representing a better response. The time-weighted average change is calculated by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.|Baseline and up to Week 6|Modified Intent-to-Treat (mITT) Population - the mITT population in Part I consisted of all randomized participants who received at least 1 dose of study treatment, had at least 1 measurement of interest post-randomization that was collected within 3 days of the last dose of study medication taken in Part I, and had baseline data.||mm VAS||95% Confidence Interval|Least Squares Mean
827555|NCT01208207|Primary|Time-Weighted Average Change From Baseline in the Spinal Pain Intensity in Study Part 1: Etoricoxib 60 mg vs. Naproxen|Spinal Pain Intensity is measured using a visual analog scale (VAS) from 0-100 mm with a lower value representing a better response. The time-weighted average change is calculated by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.|Baseline and up to Week 6|Per-Protocol Population - excluded participants due to important protocol deviations that may have had a substantial effect on the result of the primary efficacy endpoint.||mm VAS||95% Confidence Interval|Least Squares Mean
827559|NCT01208233|Secondary|Change From Baseline in Box and Blocks (B&B) Test at Day 90 for Non-paretic Hand (Part 2)|The B&B test is a measure of manual dexterity. The B&B apparatus consists of a box divided into 2 sections and 1-inch hardwood blocks. The blocks began in the compartment of the test box to the dominant side of the participant. The participant was required to transfer the blocks one at a time to the other side of the box as quickly as possible in 1 minute using the non-paretic hand. The box was then turned so all the blocks were in the same side as the paretic hand. The participant was then required to do the test with his/her paretic hand. The participant was told that if more than 1 block was picked up at a time it was to only count as 1 block. The participant was also told that their fingertips needed to cross the partition for the block to be counted. The performance measure for this task was the number of blocks moved within 1 minute.|Day 1 (Baseline), Day 90|The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg). Number of participants indicated those participants included for comparison between active drug and placebo.||blocks moved per minute||Standard Error|Least Squares Mean
827560|NCT01208233|Other Pre-specified|Treatment-emergent Adverse Events (AEs) Resulting in Discontinuation of Study Drug (Part 2)|An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.|Day 1 (Baseline) up to follow-up (28 days after Day 90)|The FAS consisted of all randomized participants who took any study medication (active or placebo).||Number of participants|||Number
827561|NCT01208233|Other Pre-specified|Number of Participants With SBP <100 mm Hg or SBP Decline >=30 mm Hg From Immediate Pre-dose Measurement, With or Without Neuro-worsening (Defined as an NIHSS Increase of 4 Points or Greater) Within 2 Hours Post-dose (Part 2)||Day 1 (Baseline) up to Day 14|The FAS consisted of all randomized participants who took any study medication (active or placebo).||Number of participants|||Number
827562|NCT01208233|Other Pre-specified|Number of Participants With Neuro-worsening (Part 2)|NIHSS change of 4 points or greater.|Day 1 (Baseline) up to Day 90|The FAS consisted of all randomized participants who took any study medication (active or placebo).||Number of participants|||Number
827563|NCT01208233|Other Pre-specified|Mortality Directly Related to Stroke (Part 2)|Deaths caused by stroke were reported.|The time began from the participant provided informed consent through 28 calendar days post last administration of investigational product.|The FAS consisted of all randomized participants who took any study medication (active or placebo).||Number of participants|||Number
827564|NCT01208233|Other Pre-specified|All-cause Mortality (Part 2)|Deaths regardless causality were reported.|The time began from the participant provided informed consent through 28 calendar days post last administration of investigational product.|The FAS consisted of all randomized participants who took any study medication (active or placebo).||Number of participants|||Number
827565|NCT01208233|Secondary|Plasma Concentrations of PF-03049423 (Part 1 and 2)||Days 1, 2, 7, 14, 30, 60 and 90|PK concentration population included all participants who were treated with PF-03049423 who had at least 1 measurable concentration. n=participants with concentration above lower limit of quantification at the corresponding sampling time.||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
827566|NCT01208233|Secondary|Gait Velocity Test at Day 90 (Part 2)|The 10-meter walk test requires a 20 meter straight path, with 5 meters for acceleration, 10 meters for steady state walking, and 5 meters for deceleration. Markers were placed at the 5 and 15 meter positions along the path. The participant began to walk “at a comfortable pace” at 1 end of the path, and continued walking until he/she reached the other end. The rater used a stopwatch to determine how much time it took for the participant to traverse the 10 meter center of the path, starting the stopwatch as soon as the participant’s limb crossed the first marker and stopping the stopwatch as soon as the participant’s limb crossed the second marker.|Day 90|The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg). Participants analyzed indicated number of participants included for comparison between active drug and placebo for this outcome measure.||meters/second (m/s)||Standard Error|Least Squares Mean
827567|NCT01208233|Secondary|Domains of Interest: Change From Baseline in Recognition Memory Test at Day 90 (Part 2)|This test assesses the ability to recognize pictures of objects. The participant was presented a series of pictures, a subset of which were the objects presented in the RBANS Naming Sub Test. After each picture was presented, the participant indicated either manually (ie, affirmative head nod) or verbally whether the picture was seen previously. The participant was given 5 seconds per picture to respond. The performance measure for this task was the total number of pictures correctly identified.|Day 1 (Baseline), Day 90|The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg). Participants analyzed indicated number of participants included for comparison between active drug and placebo for this outcome measure.||pictures correctly identified||Standard Error|Least Squares Mean
827568|NCT01208233|Secondary|Domains of Interest: Change From Baseline in Line Cancellation Test at Day 90 [(L-R)/(L+R)] (Part 2)|The participant was presented with a page that had lines placed across the page. The participant was required to cross out all the lines on the page using their non-paretic hand after the tester had demonstrated what was required by crossing out the center line. The performance measure for this task was the total number of omissions made expressed as a percentage of the total number of items in the test. The test contains 4 variables: (L+R)/28 × 100%, (L/14) × 100%, (R/14) × 100%, and (L-R)/(L+R), where L = number of lines crossed on the left side of the paper; R = number of lines crossed on the right side of the paper.|Day 1 (Baseline), Day 90|The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg). Number of participants analyzed indicated participants included for comparison between active drug and placebo for this outcome measure.||change in ratio||Standard Error|Least Squares Mean
827642|NCT01201317|Secondary|Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Worst Pain Score.|Last Observation Carried Forward (LOCF). Twice daily, the participants rated their Worst pain intensity during the past 12 hours on an Numerical Rating Scale (NRS) 0-10, 0=No pain, 10=Worst pain imaginable.|Baseline (mean of Day -5 to Day -1) to the mean of Day 24 to Day 28|Intention-to-treat set (ITT)||Scores on a scale||Standard Deviation|Mean
827569|NCT01208233|Secondary|Domains of Interest: Change From Baseline in Line Cancellation Test [(L+R)/28 × 100%, (L/14) × 100%, (R/14) × 100%)] at Day 90 (Part 2)|The participant was presented with a page that had lines placed across the page. The participant was required to cross out all the lines on the page using their non-paretic hand after the tester had demonstrated what was required by crossing out the center line. The performance measure for this task was the total number of omissions made expressed as a percentage of the total number of items in the test. The test contains 4 variables: (L+R)/28 × 100%, (L/14) × 100%, (R/14) × 100%, and (L-R)/(L+R), where L = number of lines crossed on the left side of the paper; R = number of lines crossed on the right side of the paper.|Day 1 (Baseline), Day 90|The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg). n=number of participants included for comparison between active drug and placebo for this outcome measure.||change in percentage of lines crossed||Standard Error|Least Squares Mean
827570|NCT01208233|Secondary|Domains of Interest: Change From Baseline in RBANS Naming Sub Test at Day 90 (Part 2)|This test requires the participant to name 10 objects drawn in ink. The tester asked the participant to identify the picture. The participant had 20 seconds to respond to each picture presented. The performance measure was the number of objects named correctly.|Day 1 (Baseline), Day 90|The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg). Participants analyzed indicated number of participants included for comparison between active drug and placebo for this outcome measure.||objects named correctly||Standard Error|Least Squares Mean
827571|NCT01208233|Secondary|Domains of Interest: Change From Baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Coding Sub Test at Day 90 (Part 2)|The test uses a reference key, the participant had 90 seconds to pair specific numbers with given geometric figures. Responses could be written or oral. The performance measure for this task was the total number of correct responses.|Day 1 (Baseline), Day 90|The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg). Participants analyzed indicated number of participants included for comparison between active drug and placebo for this outcome measure.||correct responses||Standard Error|Least Squares Mean
827572|NCT01208233|Secondary|BI at Day 90 (Part 2)|The BI is an index of independence to score the ability of a participant with a neuromuscular or musculoskeletal disorder to care for him or herself. The index rates a participant’s ability on the following 10 activities: feeding, moving from wheelchair to bed, personal toilet, getting on and off toilet, bathing self, walking on level surface, ascending and descending stairs, dressing, controlling bowels and controlling bladder. The maximum total score is 100 in a participant without functional impairment; the minimum score is 0 in a participant with major functional impairment.|Day 90|The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg). Participants analyzed indicated number of participants included for comparison between active drug and placebo for this outcome measure.||unit on a scale||Standard Error|Least Squares Mean
827573|NCT01208233|Secondary|Percentage of Participants With Barthel Index (BI) >= 95 and BI =100 at Day 90 (Part 2)|The BI is an index of independence to score the ability of a participant with a neuromuscular or musculoskeletal disorder to care for him or herself. The index rates a participant’s ability on the following 10 activities: feeding, moving from wheelchair to bed, personal toilet, getting on and off toilet, bathing self, walking on level surface, ascending and descending stairs, dressing, controlling bowels and controlling bladder. The maximum total score is 100 in a participant without functional impairment; the minimum score is 0 in a participant with major functional impairment.|Day 90|The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg).||percentage of participants|||Number
827574|NCT01208233|Secondary|Change From Baseline in NIHSS at Day 90 (Part 2)|The NIHSS is a graded 11-item neurological examination rating speech and language, cognition, visual field deficits, motor and sensory impairments and ataxia used for the clinical assessment of acute stroke therapy. The maximum total score is 42 in a participant with a severe neurological deficit; the minimum score is 0 in a participant without gross neurological deficits.|Day 1 (Baseline), Day 90|The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg). Participants analyzed indicated number of participants included for comparison between active drug and placebo for this outcome measure.||unit on a scale||Standard Error|Least Squares Mean
827575|NCT01208233|Secondary|Percentage of Participants With National Institutes of Health Stroke Scale (NIHSS) (0-1) at Day 90 (Part 2)|The NIHSS is a graded 11-item neurological examination rating speech and language, cognition, visual field deficits, motor and sensory impairments and ataxia used for the clinical assessment of acute stroke therapy. The maximum total score is 42 in a participant with a severe neurological deficit; the minimum score is 0 in a participant without gross neurological deficits.|Day 90|The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg).||percentage of participants|||Number
827576|NCT01208233|Secondary|Percentage of Participants With mRS (0-1) at Day 90 (Part 2)|The mRS is a 6-point scale of functional recovery. The scale grades participants as having no symptoms (0), minor symptoms (1), minor handicap (2), moderate handicap (3), moderately severe handicap (4), severe handicap (5), or death (6).|Day 90|The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg).||percentage of participants|||Number
827643|NCT01201317|Primary|Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Average Pain Score.|Last Observation Carried Forward (LOCF). Twice daily, the participants rated their Average Pain intensity during the past 12 hours on an Numerical Rating Scale (NRS) 0-10; 0=No pain, 10=Worst pain imaginable.|Baseline (mean of Day -5 to Day -1) to the mean of Day 24 to Day 28|Intention-to-treat set (ITT)||Scores on a scale||Standard Deviation|Mean
836871|NCT01301079|Primary|Pain 240 Minutes|The scale measure pain after 240 minutes (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10.|240 minutes|||units on a scale||Standard Deviation|Mean
827577|NCT01208233|Secondary|Change From Baseline in Hand Grip Strength Test at Day 90 for Paretic to Non-paretic Hand Ratio (Part 2)|The Hand Grip Strength Test measures the maximum isometric strength of the hand and forearm muscles. The participant was required to squeeze the dynamometer with maximum isometric effort while sitting with shoulder adducted and neutrally roated, elbow flexed at 90 degrees and the forearm in neutral position and wrist between 0 to 30 degrees dorsiflexion and a 0 to 15 degrees ulnar deviation. The participant performed this task 3 times with each hand, starting with the non-paretic hand. The performance measure for this task was the average score measured in pounds of pressure exerted.|Day 1 (Baseline), Day 90|The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg). Number of participants analyzed indicated those participants included for comparison between active drug and placebo.||percentage change||Standard Error|Least Squares Mean
827578|NCT01208233|Secondary|Change From Baseline in Hand Grip Strength Test at Day 90 for Paretic and Non-paretic Hands (Part 2)|The Hand Grip Strength Test measures the maximum isometric strength of the hand and forearm muscles. The participant was required to squeeze the dynamometer with maximum isometric effort while sitting with shoulder adducted and neutrally roated, elbow flexed at 90 degrees and the forearm in neutral position and wrist between 0 to 30 degrees dorsiflexion and a 0 to 15 degrees ulnar deviation. The participant performed this task 3 times with each hand, starting with the non-paretic hand. The performance measure for this task was the average score measured in pounds of pressure exerted.|Day 1 (Baseline), Day 90|The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg). n=number of participants included for comparison between active drug and placebo.||pounds||Standard Error|Least Squares Mean
827579|NCT01208233|Secondary|Change From Baseline in Box and Blocks (B&B) Test at Day 90 for Paretic to Non-paretic Hand Ratio (Part 2)|The B&B test is a measure of manual dexterity. The B&B apparatus consists of a box divided into 2 sections and 1-inch hardwood blocks. The blocks began in the compartment of the test box to the dominant side of the participant. The participant was required to transfer the blocks one at a time to the other side of the box as quickly as possible in 1 minute using the non-paretic hand. The box was then turned so all the blocks were in the same side as the paretic hand. The participant was then required to do the test with his/her paretic hand. The participant was told that if more than 1 block was picked up at a time it was to only count as 1 block. The participant was also told that their fingertips needed to cross the partition for the block to be counted. The performance measure for this task was the number of blocks moved within 1 minute.|Day 1 (Baseline), Day 90|The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg). Number of participants indicated those participants included for comparison between active drug and placebo.||percentage change||Standard Error|Least Squares Mean
827580|NCT01208233|Secondary|Change From Baseline in Box and Blocks (B&B) Test at Day 90 for Paretic Hand (Part 2)|The B&B test is a measure of manual dexterity. The B&B apparatus consists of a box divided into 2 sections and 1-inch hardwood blocks. The blocks began in the compartment of the test box to the dominant side of the participant. The participant was required to transfer the blocks one at a time to the other side of the box as quickly as possible in 1 minute using the non-paretic hand. The box was then turned so all the blocks were in the same side as the paretic hand. The participant was then required to do the test with his/her paretic hand. The participant was told that if more than 1 block was picked up at a time it was to only count as 1 block. The participant was also told that their fingertips needed to cross the partition for the block to be counted. The performance measure for this task was the number of blocks moved within 1 minute.|Day 1 (Baseline), Day 90|The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg). Number of participants indicated those participants included for comparison between active drug and placebo.||blocks moved per minute||Standard Error|Least Squares Mean
827581|NCT01208233|Primary|Percentage of Participants With Modified Rankin Scale (mRS) Less Than or Equal to (<=2) at Day 90 (Part 2)|The mRS is a 6-point scale of functional recovery. The scale grades participants as having no symptoms (0), minor symptoms (1), minor handicap (2), moderate handicap (3), moderately severe handicap (4), severe handicap (5), or death (6).|Day 90|The Inferential Full Analysis Set (I-FAS) consisted of participants within the FAS who were randomized to PF-03049423 maximum tolerated dose (MTD) or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg). n=number of participants included for comparison between active drug and placebo.||percentage of participants|||Number
827582|NCT01208233|Primary|Number of Participants With Suicidal Behavior and/or Ideation as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) (Part 1* and 2)|"Data were mapped to Columbia-Classification Algorithm of Suicide Assessment (C-CASA) event codes. C-SSRS assessed if participant experienced: completed suicide (Code 1), suicide attempt (Code 2) (Response of “Yes” on “actual attempt”), preparatory acts toward imminent suicidal behavior (Code 3) (“Yes” on “aborted attempt”, interrupted attempt”, preparatory acts or behavior”), suicidal ideation (Code 4) (“Yes” on “wish to be dead”, non-specific active suicidal thoughts”, active suicidal ideation with methods without intent to act/some intent to act without specific plan or with specific plan and intent), self-injurious behavior, no suicidal intent (Code 7) (“Yes” on “Has participant engaged in non-suicidal self-injurious behavior”). Number of participants with Yes response for any of above mentioned categories was assessed. *This was a primary endpoint for Part 1 (timeframe Days 1 to 14), as data for it were not reported separately, Part 1 and 2 data were reported together."|Day 7 (Baseline) up to follow up (28 days after Day 90)|The FAS consisted of all randomized participants who took any study medication (active or placebo). n=number of participants who had C-SSRS assessed at that visit.||participants|||Number
827644|NCT01201343|Secondary|Change From Baseline in Fatigue Score at Months 1, 2, 3, 6, 12 and 24|Fatigue scale was derived from the United Kingdom Neurological Disability Scale (UKNDS), and evaluates fatigue according to the participant's subjective impression and the functional disability that it causes. 'Yes' or 'No' answers result in a score that ranges from 0 to 5, where a score 5 shows worse state. (Sharrack B et al., 1999)|Baseline, Months 1, 2, 3, 6, 12, and 24|ITT population. 'N' (number of participants analyzed) signifies those participants who were evaluated for this measure. 'n' signifies those participants who were evaluated for this measure at that time point.||units on a scale||Standard Deviation|Mean
827583|NCT01208233|Primary|Number of Participants With Significant Change in Neurological Examination Findings (Part 1* and 2)|The complete neurological examination included an assessment of the motor, sensory, cranial nerves, reflexes, mental status and associated motor functions. The limited neurological exam could examine the same categories of neurologic assessments as the full examination, but would differ by the depth in the examination. The examination was required to be done to the extent needed to assess the participant for any potential changes in neurological status, as determined by the Investigator, but had to always include an assessment of motor, vision and hearing. *This endpoint was a primary endpoint for Part 1 (timeframe Days 1 to 14), as data for this timeframe were not reported separately, Part 1 and 2 data were reported together.|Day 1 (Baseline) up to Day 90|The FAS consisted of all randomized participants who took any study medication (active or placebo). Participants analyzed indicated those who had neurological examinations done at both baseline and last visit.||participants|||Number
827584|NCT01208233|Primary|Number of Participants With Significant Change in Physical Examination Findings (Part 1* and 2)|The complete physical examination included examination of the skin, eyes, ears, throat, neck, cardiac, respiratory, gastrointestinal, and musculoskeletal systems. The limited physical examination included examination of the cardiac, respiratory, gastrointestinal, and musculoskeletal systems. *This endpoint was a primary endpoint for Part 1 (timeframe Days 1 to 14), as data for this timeframe were not reported separately, Part 1 and 2 data were reported together.|Day 1 (Baseline) up to Day 90|The FAS consisted of all randomized participants who took any study medication (active or placebo). Participants analyzed indicated those who had physical examinations done at both baseline and last visit.||participants|||Number
827585|NCT01208233|Primary|Number of Participants With Electrocardiograms (ECGs) Data Met Criteria of Potential Clinical Concern (Part 1* and 2)|ECG criteria of potential clinical concern were 1), PR interval: >=300 milliseconds (msec); >=25% increase when baseline >200 msec; or increase >=50% when baseline <=200 msec; 2), QRS interval: >=140 msec; >=50% increase from baseline; 3), QT interval: >=500 msec, QTc interval using Fridericia’s formula (QTcF interval): absolute value >=450 - <480 msec, >=480-<500 msec, >=500 msec; absolute change 30 - <60, >=60 msec. *This endpoint was a primary endpoint for Part 1 (timeframe Days 1 to 14), as data for this timeframe were not reported separately, Part 1 and 2 data were reported together.|Day 1 (Baseline) to Day 90|The FAS consisted of all randomized participants who took any study medication (active or placebo). n=number of evaluable participants.||participants|||Number
827586|NCT01208233|Primary|Number of Participants With Vital Signs Data Met Criteria of Potential Clinical Concern (Part 1* and 2)|Vital signs included blood pressure (BP; supine, sitting and standing) and pulse rate. Vital signs criteria of potential clinical concern were 1), BP: systolic BP (SBP) greater than or equal to (>=) 30 or 50 millimeters of mercury (mm Hg) change from grand baseline in same posture, systolic less than (<) 90 mm Hg; diastolic BP (DBP) >=20 mm Hg change from grand baseline in same posture, diastolic <50 mm Hg; 2), pulse rate (supine, sitting and standing): <40 or greater than (>) 120 beats per minute (bpm); Standing: <40 or >140 bpm. *This endpoint was a primary endpoint for Part 1 (timeframe Days 1 to 14), as data for this timeframe were not reported separately, Part 1 and 2 data were reported together.|Day 1 (Baseline) up to follow-up (28 days after Day 90)|The FAS consisted of all randomized participants who took any study medication (active or placebo). n=number of evaluable participants.||participants|||Number
827587|NCT01208233|Primary|Number of Participants With Any Abnormal Laboratory Test Results (Part 1* and 2)|The total number of participants with laboratory test abnormalities (without regard to baseline abnormality) was assessed. *This endpoint was a primary endpoint for Part 1 (timeframe Days 1 to 14), as data for this timeframe were not reported separately, Part 1 and 2 data were reported together.|Day 1 (Baseline) up to Day 90|The FAS consisted of all randomized participants who took any study medication (active or placebo). Participants analyzed indicated number of participants evaluated.||participants|||Number
827588|NCT01200758|Secondary|Percentage of Responses Who Showed Rituximab SC Formulation Convenient as Compared to Rituximab IV Formulation as Assessed by Physician/Nurse Opinion|"All investigator physicians and nurses involved in this study were asked to complete question i.e. Which formulation of rituximab (SC or IV) do you think is more convenient? based on their experience with the rituximab SC and IV formulations across all participants and presented as rituximab SC is much more convenient; rituximab SC is a little more convenient; both formulations are equally convenient; rituximab IV is a little more convenient; and rituximab IV is much more convenient."|After Cycle 8 of induction treatment (24 weeks) and during the maintenance part of the study after 12 months (i.e., Cycle 15), and after the end of the maintenance treatment, (i.e., Cycle 20) (1 Cycle=4 weeks for Cycle 8 and 8 weeks for Cycles 15 and 20)|"ITT Population. Here, number of participants analyzed = participants evaluable for the outcome measure. Here n = number of participants evaluable for this outcome measure at specified timepoint."||percentage of responses|||Number
827589|NCT01200758|Secondary|Stage I and II (Pooled): Percentage of Responses Showing Time Saved of Staff as Per Physician/Nurse Opinions With Each Administration of Rituximab SC as Compared to Rituximab IV at the End of Cy 8, 15 and 20|All investigator physicians and nurses involved in this study were asked to provide the staff time that could be saved with each administration of rituximab SC as compared with rituximab IV to participants in routine practice afetr Cy 8, 15, 20 and categorized as less than (<) 1 hr, at least 1 hr but <2 hrs, at least 2 hrs but <3 hrs, at least 3 hrs but <4 hrs, >/=4 hrs. Staff were asked not to consider the time needed for the first IV administration. Analysis was done in all participants to show a comparison on the time saved by staffs when administered via SC and IV.|After Cycle 8 of induction treatment (24 weeks) and during the maintenance part of the study after 12 months (i.e., Cycle 15), and after the end of the maintenance treatment, (i.e., Cycle 20) (1 Cycle=4 weeks for Cycle 8 and 8 weeks for Cycles 15 and 20)|"ITT Population. Here, number of participants analyzed = participants evaluable for the outcome measure. Here n = number of participants evaluable for this outcome measure at specified timepoint."||percentage of responses|||Number
827652|NCT01208337|Secondary|Incidence of Patients in Whom Steroids Are Not Used|As part of analysis for assessing effectiveness and safety of Alemtuzumab Induction at the time of transplant, it is important to assess the incidence in which patients enrolled were able to wean off of steroids post-transplant compared to historical controls.|5 year|Induction of Alemtuzumab at time of transplant may increase the likelihood of weaning off steroids sooner after transplant than patients who did not receive Alemtuzumab as induction immunosuppression medication.||participants|||Number
827590|NCT01200758|Secondary|Stage I and II (Pooled): Percentage of Participants Positive for Human Anti-Human Antibodies (HAHAs) to Rituximab|Levels of HAHA in serum were detected at Day 1 of each cycle up to Cycle 8 and at follow-up visit. Stage I and II: Baseline: pre-dose (72 hours prior) D1 of Cy1, Cy 3-20, D0 of Cy2 (1 Cy=3 weeks for Cy1-8 & 8 weeks for Cy9-20), post-baseline: every 12 weeks after last rituximab administration until 96 weeks (a median of 27 months; up to data cutoff of 11 Jan 2016 [up to 6 years])|Stage I and II: Baseline, post-baseline (See detailed timeframe in Outcome Measure description)|"Safety Analysis Population. Here, number of participants analyzed = participants evaluable for the outcome measure. Here n = number of participants evaluable for this outcome measure at specified timepoint."||percentage of participants|||Number
827591|NCT01200758|Secondary|Stage I and II (Pooled): Percentage of Participants Positive for Human Anti-Chimeric Antibodies (HACAs) to Rituximab|Levels of HACA in serum were detected at Day 1 of each cycle up to Cycle 8 and at follow-up visit. Stage I and II: Baseline: pre-dose (72 hours prior) D1 of Cy1, Cy 3-20, D0 of Cy2 (1 Cy=3 weeks for Cy1-8 & 8 weeks for Cy9-20), post-baseline: every 12 weeks after last rituximab administration until 96 weeks (a median of 27 months; up to data cutoff of 11 Jan 2016 [up to 6 years])|Stage I and II: Baseline, post-baseline (See detailed timeframe in Outcome Measure description)|"Safety Analysis Population: included 6 participants who were randomized under Rituximab SC arm but withdrew after Cy1 and then analyzed under Rituximab IV arm. Here, number of participants analyzed = participants evaluable for the outcome measure. Here n = number of participants evaluable for this outcome measure at specified timepoint."||percentage of participants|||Number
827592|NCT01200758|Secondary|Percentage of Participants With B-Cell Depletion by Cycle for Maintenance Phase|Depletion is defined as a CD19 value <80 cells/mm^3.|Stage I and II (maintenance): D1 of Cy 9 to 20 (1 Cy=8 weeks) (up to data cutoff of 11 Jan 2016 [up to 6 years])|"ITT Population. Here, number of participants analyzed = participants evaluable for the outcome measure. Here n = number of participants evaluable for this outcome measure at specified timepoint."||percentage of participants|||Number
827593|NCT01200758|Secondary|Percentage of Participants With B-Cell Depletion by Cycle for Induction Phase|Depletion is defined as a cluster of differentiation (CD) 19 value <80 cells per cubic millimeter (cells/mm^3).|Stage I and II (induction): for rituximab IV - D1 of Cy 1 to 8 (1 Cy=3 weeks); for rituximab SC - D1 of Cy 1 and Cy 3 to 8, D0 of Cy 2|"ITT Population. Here, number of participants analyzed = participants evaluable for the outcome measure. Here n = number of participants evaluable for this outcome measure at specified timepoint."||percentage of participants|||Number
827594|NCT01200758|Secondary|Stage I and II (Pooled): Rituximab Levels 12 Weeks, 24 Weeks, and 36 Weeks After the Last Rituximab Administration||12 weeks, 24 weeks, and 36 weeks after the last rituximab administration (up to data cutoff of 11 Jan 2016 [up to 6 years])|"Safety Analysis Population included all participants who received at least one dose of rituximab, either IV or SC. Participants were analyzed as treated. Here, number of participants analyzed = participants evaluable for the outcome measure. Here n = number of participants evaluable for this outcome measure at specified timepoint."||mcg/mL||Full Range|Median
827595|NCT01200758|Secondary|Stage I and II (Pooled): Ctrough of Rituximab at Each Maintenance Treatment Cycle|Stage I and II (maintenance): D29 of Cy8 (induction; 1 Cy=4 weeks), predose (within 2 hr) on D1 of Cy9 to 19 (maintenance Cy1 to 12 [1 Cy=8 weeks]; up to data cutoff of 11 Jan 2016 [up to 6 years])|Stage I and II (maintenance): Predose (within 2hr) up to data cutoff of 11 Jan 2016 [up to 6 years]) (See detailed timeframe in Outcome Measure description)|"ITT Population. Here, number of participants analyzed = participants evaluable for the outcome measure. Here n = number of participants evaluable for this outcome measure at specified timepoint."||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
827596|NCT01200758|Secondary|Stage I and II (Pooled): Ctrough of Rituximab at Each Induction Treatment Cycle|Stage I and II (Induction): Rituximab IV: Predose (within 2 hr) on D1 of Cy1-8 (1 Cy=3 weeks & 4 weeks for Cy8); Rituximab SC: Predose (within 2 hr) on D1 of Cy1 & Cy3-8 (1 Cy=3 weeks and 4 weeks for Cy8), predose (within 2 hr) on D0 of Cy2 (up to data cutoff of 31 Oct 2013 [up to 32 months])|Stage I and II (Pooled): Predose (within 2hr) up to data cutoff of 31 Oct 2013 [up to 32 months]) (See detailed timeframe in Outcome Measure description)|"ITT Population. Here, number of participants analyzed = participants evaluable for the outcome measure. Here n = number of participants evaluable for this outcome measure at specified timepoint."||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
827597|NCT01200758|Secondary|Stage I: Maximum Serum Concentrations (Cmax) of IV and SC Rituximab|Predose (within 2 hr) and 24 hrs postdose on Cy7 (D1,3,7,15), predose (0 hr) on Cy8 D1 (1 Cy=3 weeks); additionally within 15 minutes after end of infusion (infusion duration=30 minutes) on Cy7 D1 for rituximab IV (up to data cutoff of 11 Apr 2012 [up to 26 months])|Stage I (Induction): Predose (within 2hr) up to data cutoff of 11 Apr 2012 [up to 26 months]) (See detailed timeframe in Outcome Measure description)|Stage 1 PK Evaluable Population. Here, number of participants analyzed = participants evaluable for this outcome measure.||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
827598|NCT01200758|Secondary|Stage 1: Observed Area Under the Serum Concentration-Time Curve (AUC) of Rituximab|AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. Predose (within 2 hr) and 24 hrs postdose on Cy 7 (D1,3,7,15), predose (0 hr) on Cy 8 D1 (1 Cy=3 weeks); additionally within 15 minutes after end of infusion (infusion duration=30 minutes) on Cy 7 D1 for rituximab IV (up to data cutoff of 11 Apr 2012 [up to 26 months])|Stage I (Induction): Predose (within 2 hour [hr]) up to data cutoff of 11 Apr 2012 [up to 26 months]) (See detailed timeframe in Outcome Measure description)|Stage I PK evaluable population. Here, number of participants analyzed = participants evaluable for this outcome measure.||mcg*day/mL||Geometric Coefficient of Variation|Geometric Mean
827599|NCT01200758|Secondary|Overall Survival (OS)|OS was defined as the time from randomization to death due to any cause. Participants without event were censored at the time of last follow-up information for survival, ie, at the last time known to be alive.|Baseline up to death (up to data cutoff of 11 Jan 2016 [up to 6 years])|ITT population.||days||95% Confidence Interval|Median
827600|NCT01200758|Secondary|Percentage of Participants Who Died||Baseline up to death (up to data cutoff of 11 Jan 2016 [up to 6 years])|ITT population.||percentage of participants|||Number
827653|NCT01208337|Secondary|Incidence of Patients in Whom Tacrolimus Whole Blood Concentration Less Than 10 ng/ml Are Being Used at 1-year Follow-up.|Tacrolimus whole blood concentrations less than 10 ng/ml|1 year|It is believed that patients whom received Alemtuzumab at the time of transplant and continue post-transplant with functioning grafts will have Tacrolimus whole blood concentrations less than 10ng/ml.||participants|||Number
827601|NCT01200758|Secondary|Stage I and II (Pooled): Event-Free Survival Assessed Using International Working Group Response Criteria for NHL|Event-free survival was defined as the time from randomization to disease progression/relapse, death or initiation of new NHL therapy. If the specified event (progression/relapse, death or new anti-lymphoma treatment) did not occur, event-free survival was censored at the last tumor assessment date either during treatment or follow up. Event-free survival analysis was performed using Kaplan-Meier curves. Baseline, D1 of all cycles (Cy 1-20) (1 Cy=3 weeks for Cy1-8 & 8 weeks for Cy9-20), at early withdrawal, at follow-up, every 12 weeks for 96 weeks or until documented disease progression/relapse or death (up to a median of 27 months; up to data cutoff of 11 Jan 2016 [up to 6 years])|Baseline up to disease progression or death up to data cutoff of 11 Jan 2016 (up to 6 years) (See detailed timeframe in Outcome Measure description)|ITT population.||days||95% Confidence Interval|Median
827602|NCT01200758|Secondary|Stage 1 and II (Pooled): Percentage of Participants With Disease Progression/Relapse, New Anti-Lymphoma Treatment or Death Assessed Using International Working Group Response Criteria for NHL|Disease progression: ≥50% increase from nadir in the SPD of any previously identified abnormal node or appearance of any new lesion during or at the end of therapy or ≥50% increase in the greatest diameter of any previously identified node >1 cm in its short axis or in the SPD of more than one node. Baseline, D1 of all cycles (Cy 1-20) (1 Cy=3 weeks for Cy1-8 & 8 weeks for Cy9-20), at early withdrawal, at follow-up, every 12 weeks for 96 weeks or until documented disease progression/relapse or death (up to a median of 27 months; up to data cutoff of 11 Jan 2016 [up to 6 years])|Baseline up to disease progression or death up to data cutoff of 11 Jan 2016 (up to 6 years) (See detailed timeframe in Outcome Measure description)|ITT population.||percentage of participants|||Number
827603|NCT01200758|Secondary|Stage 1 and II (Pooled): Progression-Free Survival (PFS) Assessed Using International Working Group Response Criteria for NHL|PFS was defined as the time from randomization to disease progression/relapse or death due to any cause. If the specified event (disease progression/relapse, death) did not occur, PFS was censored at the last tumor assessment date showing no disease progression, either during treatment or follow-up. Disease progression: ≥50% increase from nadir in the SPD of any previously identified abnormal node or appearance of any new lesion during or at the end of therapy or ≥50% increase in the greatest diameter of any previously identified node >1 cm in its short axis or in the SPD of more than one node. PFS analysis was performed using Kaplan – Meier curves. Baseline, D1 of all cycles (Cy 1-20) (1 Cy=3 weeks for Cy1-8 & 8 weeks for Cy9-20), at early withdrawal, at follow-up, every 12 weeks for 96 weeks or until documented disease progression/relapse or death (up to median of 27 months; up to data cutoff of 11 Jan 2016 [up to 6 years])|Baseline up to disease progression or death up to data cutoff of 11 Jan 2016 (up to 6 years) (See detailed timeframe in Outcome Measure description)|ITT Population.||days||95% Confidence Interval|Median
827604|NCT01200758|Secondary|Stage 1 and II (Pooled): Percentage of Participants With Disease Progression/Relapse or Death|Disease progression: ≥50% increase from nadir in the SPD of any previously identified abnormal node or appearance of any new lesion during or at the end of therapy or ≥50% increase in the greatest diameter of any previously identified node >1 cm in its short axis or in the SPD of more than one node. Baseline, D1 of all cycles (Cy 1-20) (1 Cy=3 weeks for Cy1-8 & 8 weeks for Cy9-20), at early withdrawal, at follow-up, every 12 weeks for 96 weeks or until documented disease progression/relapse or death (up to median of 27 months; up to data cutoff of 11 Jan 2016 [up to 6 years])|Baseline up to disease progression or death up to data cutoff of 11 Jan 2016 (up to 6 years) (See detailed timeframe in Outcome Measure description)|ITT Population.||percentage of participants|||Number
827605|NCT01200758|Secondary|Stage I and II (Pooled): Percentage of Participants With Overall Response at the End of Maintenance Treatment Assessed Using International Working Group Response Criteria for NHL|Overall Response comprised of CR, CRu, or PR . A participant was defined as a responder if they sustained a CR, CRu or PR at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by >75% in SPD. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper.|Stage I and II: Baseline up to 57 days after last maintenance dose (last maintenance dose: maintenance Cy12/Study Cy20 [30 months]) (up to data cutoff of 11 Jan 2016 [up to 6 years]) (1 Cy=8 weeks)|ITT population; only participants who entered the maintenance phase and received at least 1 cycle of rituximab maintenance treatment from Cycle 9 to Cycle 20 were included in the analysis.||percentage of participants||95% Confidence Interval|Number
827606|NCT01200758|Secondary|Stage I and II (Pooled): Percentage of Participants With Complete Response at the End of Maintenance Treatment Assessed Using International Working Group Response Criteria for NHL|Complete Response comprised of CR and CRu. A participant was defined as a responder if they sustained a CR or CRu at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by >75% in SPD. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper.|Stage I and II: Baseline up to 57 days after last maintenance dose (last maintenance dose: maintenance Cy12/Study Cy20 [30 months]) (up to data cutoff of 11 Jan 2016 [up to 6 years]) (1 Cy=8 weeks)|ITT population; only participants who entered the maintenance phase and received at least 1 cycle of rituximab maintenance treatment from Cycle 9 to Cycle 20 were included in the analysis.||percentage of participants||95% Confidence Interval|Number
827614|NCT01200797|Primary|Time to Progression (TTP)|Estimated probable duration from on‐study date to date of disease progression, using the Kaplan‐Meier method with censoring (see analysis population description for additional details). Disease progression is defined under RECIST v1.1 as >=20% increase in sum of longest diameters of target lesions, unequivocal progression of non‐target lesions, or appearance of new lesions.|On‐study date to date of progression (assessed up to 12 months)|All patients are included in the analysis on intention-to-treat basis. Analysis is by Kaplan‐Meier method, where progression is an event, with censoring for non-progressed patients at greater of off‐study date, last known alive date, or date of death not attributable to disease progression.||days||95% Confidence Interval|Median
827607|NCT01200758|Secondary|Stage I and II (Pooled): Percentage of Participants With Complete Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL|Complete Response comprised of CR and CRu. A participant was defined as a responder if they sustained a CR or CRu at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by >75% in SPD. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper.|Stage I and II: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks)|ITT Population.||percentage of participants||95% Confidence Interval|Number
827608|NCT01200758|Secondary|Stage II: Percentage of Participants With Complete Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL|Complete Response comprised of CR and CRu. A participant was defined as a responder if they sustained a CR or CRu at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by >75% in SPD. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper.|Stage II: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks)|Stage II ITT Population.||percentage of participants||95% Confidence Interval|Number
827609|NCT01200758|Secondary|Stage I: Percentage of Participants With Complete Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL|Complete Response was comprised CR and CRu. A participant was defined as a responder if they sustained a CR or CRu at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by >75% in SPD. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper.|Stage I: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks)|Stage I ITT Population.||percentage of participants||95% Confidence Interval|Number
827610|NCT01200758|Secondary|Stage I and II (Pooled): Percentage of Participants With Overall Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL|Overall Response comprised of CR, CRu, or PR. A participant was defined as a responder if they sustained a CR, CRu or PR at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumour response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by >75% in SPD; PR: ≥50% decrease in SPD of 6 largest dominant nodes or nodal masses. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper.|Stage I and II: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks)|ITT Population.||percentage of participants||95% Confidence Interval|Number
827611|NCT01200758|Secondary|Stage I: Percentage of Participants With Overall Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL|Overall Response comprised CR, CRu, or PR. A participant was defined as a responder if they sustained a CR, CRu or PR at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by >75% in the SPD; PR: ≥50% decrease in SPD of 6 largest dominant nodes or nodal masses. The 95% CI was estimated for one sample binomial using Pearson-Clopper.|Stage I: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks)|Stage I ITT Population included all participants who were randomized in Stage I irrespective whether they received study drug or not.||percentage of participants||95% Confidence Interval|Number
827612|NCT01200758|Primary|Stage II: Percentage of Participants With Overall Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for Non-Hodgkin Lymphoma (NHL)|Overall Response comprised complete response (CR), CR unconfirmed (CRu), or PR. A participant was defined as a responder if they sustained a CR, CRu or PR at the end of induction treatment. Response assessment was based on clinical examination and computed tomography (CT) scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by more than (>) 75% in the sum of the products of greatest diameters (SPD); PR: Greater than or equal to (≥) 50% decrease in SPD of 6 largest dominant nodes or nodal masses. The 95% CI was estimated for one sample binomial using Pearson-Clopper.|Stage II: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks)|Stage II ITT Population included all participants who were randomized in Stage II irrespective whether they received study drug or not.||percentage of participants||95% Confidence Interval|Number
827613|NCT01200758|Primary|Stage I: Trough Serum Concentrations (Ctrough) of IV and SC Rituximab||Stage I: Cycle (Cy) 7 Day (D) 21 (within 2 hours predose on Cy8) of induction treatment (1 Cy=3 weeks)|Stage I pharmacokinetic (PK) evaluable population comprised all participants with data for Ctrough available at Cycle 7 and/or observed area under the serum concentration-time curve (AUC) available at Cycle 7. Participants were analyzed as per treatment received. Number of participants analyzed = participants analyzed for this outcome measure.||micrograms per milliliter (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
827692|NCT01209286|Secondary|Overall Survival|Overall survival was measured for all participants from the date of first infusion of blinatumomab until the date of death due to any cause. Participants who did not die were censored on the last documented visit date. Overall survival was estimated using Kaplan-Meier methods.|Up to the data cut-off date of 15 October 2012; maximum follow up time was 667 days.|Full analysis set||days||95% Confidence Interval|Median
827616|NCT01200797|Primary|Progression-free Survival (PFS)|Estimated probable duration of life without disease progression, from on‐study date to earlier of progression date or date of death from any cause, using the Kaplan‐Meier method with censoring (see analysis population description for additional details). Disease progression is defined under RECIST v1.1 as >=20% increase in sum of longest diameters of target lesions, unequivocal progression of non‐target lesions, or appearance of new lesions.|On‐study date to lesser of date of progression or date of (assessed up to 12 months)|All patients are included in the analysis on intention‐to-treat basis. Analysis is by Kaplan‐Meier method, where either death or progression is an event, with censoring for non‐progressed, non‐expired patients at greater of off‐study date or last known alive date.||days||95% Confidence Interval|Median
827617|NCT01200797|Primary|Number of Patients With Each Worst-grade Toxicity|Count of patients according to the worst‐grade toxicity experienced by each, where worst‐grade toxicity is per NCI common toxicity criteria: grade 1, mild; grade 2, moderate; grade 3, severe; grade 4, life‐threatening; grade 5, death.|On‐study date to 30 days following final dose of study|Total number of patients reported with any toxicity. Not all participants may have an adverse event, thus not every patient on-treatment may be accounted for in worst-grade toxicities.||participants|||Number
827618|NCT01200797|Primary|Overall Response (OR)|Number of patients in each response category, per RECIST v1.1, summarized as follows for target lesion criteria (see RECIST v1.1 for additional details): complete response (CR),disappearance of target lesions; partial response (PR), >=30% decrease in sum of longest diameter (LD) of target lesions; progressive disease (PD), >=20% increase in sum of LD of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or PR. Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR>PR>SD>PD. Confirmation of CR or PR is required to deem either one the best overall response.|On‐treatment date to date of disease progression (assessed up to 12 months)|All patients with best overall response data; patients are excluded if best overall response data is missing or if the patient is nonevaluable for best overall response||participants|||Number
827619|NCT01200810|Secondary|Safety and Tolerability Assessed Using NCI CTCAE Version 4.0|Number of participants randomized to RO4929097 arm who experienced serious adverse events .|Up to 12 months|||participants|||Number
827620|NCT01200810|Secondary|Proportion of Patients With PSA Progression During the Observation Phase||Up to 12 months|Analysis could not be conducted as study was terminated early due to lack of study drug. No subjects entered the observation phase.|||||
827621|NCT01200810|Secondary|Time to PSA Progression During the Observation Phase||Up to 12 months|Analysis could not be conducted as study was terminated early due to lack of study drug. No subjects entered the observation phase.|||||
827622|NCT01200810|Secondary|Time to PSA Progression During the Combination Phase||Up to 12 months||||||
827623|NCT01200810|Secondary|Time to PSA Nadir During the Combination Phase||Up to 12 months|Analysis could not be conducted as study was terminated early due to lack of study drug.|||||
827624|NCT01200810|Secondary|Proportion of Patients With PSA Progression During the Combination Phase||Up to 12 months|Analysis could not be conducted as study was terminated early due to lack of study drug. Only three patients started combination phase and were then removed from study due to lack of study drug.|||||
827625|NCT01200810|Secondary|Proportion of Patients Who Achieve Complete Response (by PSA) During the Combination Phase||Up to 12 months|Analysis could not be conducted as study was terminated early due to lack of study drug. Only three patients started combination phase and were then removed from study due to lack of study drug.|||||
827626|NCT01200810|Primary|Time to PSA Progression|Time to PSA progression will be compared in the two groups using a log-rank test for a maximum of 54 weeks.|Up to 12 months|Analysis could not be conducted as the protocol was terminated early due to lack of study drug. Only three patients progressed during randomization phase.|||||
827627|NCT01200875|Primary|Blood Growth Factor Concentrations||5 days following PRP injection|||IGF-1 fold-change from baseline @ 24h||95% Confidence Interval|Mean
827628|NCT01200992|Secondary|Comparison of Safety of EN3348 With Mitomycin C [Adverse Events (Other Than Serious Adverse Events) With Frequency Threshold of 5% or Greater].|Safety endpoint displayed includes adverse events (other than serious adverse events) with a frequency threshold of 5% or greater, for each treatment arm. No statistical comparisons have been performed between the 2 treatment arms.|Through study early termination, approximately 23 months from first subject enrolled.|Relevant safety data are presented in the Adverse Events and Serious Adverse Events Modules. Any clinically significant findings pertaining to other secondary outcomes such as vital signs, physical exams and laboratory test results would appear in these Modules as well. No statistical comparisons have been performed between the 2 treatment arms.||participants|||Number
827629|NCT01200992|Primary|Comparison of Event-free Survival of Intravesical EN3348 With Mitomycin C.|Primary efficacy endpoint will be event-free survival - the interval from randomization to an event. An event is defined as tumor recurrence, tumor progression to muscle invasive bladder cancer or death, whichever occurs first. Tumor recurrence or progression must be documented by bladder biopsy.|1 year|The study was discontinued early. The number of subjects randomized at time of closure represented 18.7% of the planned enrollment of 450 subjects. Thus, the planned analysis as stated in the protocol was not performed. Only 2 subjects (5.1%) in the EN3348 arm and 4 subjects (8.9%) in the mitomycin C arm completed all planned doses.|||||
827630|NCT01201265|Secondary|Change From Baseline in Diastolic Blood Pressure (DBP)|Change from baseline in DBP was analyzed by overall response (CR+PR, SD+PD).|Baseline, Cycle 6, 12 of treatment|Safety population included all participants who received at least one dose of study treatment. Here, n signifies the number of participants evaluable at specified time points.||mmHg||Standard Deviation|Mean
827631|NCT01201265|Secondary|Change From Baseline in Systolic Blood Pressure (SBP)|Change from baseline in SBP was analyzed by overall response (CR+PR, SD+PD).|Baseline, Cycle 6, 12 of treatment|Safety population included all participants who received at least one dose of study treatment. Here, n signifies the number of participants evaluable at specified time points.||millimetre of mercury (mmHg)||Standard Deviation|Mean
827741|NCT01209702|Secondary|Part 2: Elimination Half-life of Tocilizumab|Elimination half-life of tocilizumab at steady state after 12 weeks of treatment.|Week 12, pre-dose and at the end of infusion, on the 2nd and 7th day of Week 12, 14 days post-dose (Week 14) and 28 days post-dose (pre-dose of Week 16 infusion).|Due to premature study termination pharmacokinetic parameters were not analyzed.|||||
827632|NCT01201265|Secondary|Change From Baseline to Cycle 6 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30)|The EORTC QLQ-C30 (version 3.0) questionnaire incorporates 9 multi scale items: 5 functional scales (physical, role, cognitive, emotional and social); 3 symptom scales (fatigue, pain and nausea & vomiting); and a global health and quality-of-life scale. It contains 30 questions. The score for each item and the overall score ranges from 0 to 100. A high overall scale and subscale scores represent improved health status. However, in case of symptoms, higher scores suggest increased perception of these symptoms.|Baseline, cycle 6|Efficacy analysis population included all participants who received at least one dose of study treatment and with at least one efficacy assessment. Here, n signifies the number of participants evaluable at specified time points.||units on a scale||Standard Deviation|Mean
827633|NCT01201265|Secondary|Number of Participants With an Adverse Event (AE)|An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Up to 28 days after termination of study treatment (approximately 1569 days)|Safety population included all participants who received at least one dose of study treatment.||participants|||Number
827634|NCT01201265|Secondary|Overall Survival (OS)|Overall survival was measured from the date of the first study drug dose to the date of death from any cause. The median overall survival time with 95%CI was estimated using Kaplan-Meier method.|From the date of registration until the disease progression or death (up to 1541 days)|Efficacy analysis population included all participants who received at least one dose of study treatment and with at least one efficacy assessment.||days||95% Confidence Interval|Median
827635|NCT01201265|Secondary|Time to Progression (TTP)|Duration of time to progression (TTP) was estimated using the Kaplan-Meier method. The time to progression was calculated in days from the date of registration until the earliest date of documented disease progression.|From the date of registration until the disease progression (up to 1541 days).|Efficacy analysis population included all participants who received at least one dose of study treatment and with at least one efficacy assessment.||days||95% Confidence Interval|Median
827636|NCT01201265|Secondary|Percentage of Participants Achieving a Clinical Benefit Response (CBR)|Clinical benefit response was defined as a complete response (CR), partial response (PR) or stable disease (SD). CBR was assessed using Recist v.1.1. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.|From the date of registration until the disease progression or death (up to 1541 days)|Efficacy analysis population included all participants who received at least one dose of study treatment and with at least one efficacy assessment.||percentage of participants||95% Confidence Interval|Number
827637|NCT01201265|Secondary|Percentage of Participants Achieving an Overall Response|The overall response rate (ORR) was defined as complete response (CR) + partial response (PR). ORR was summarized using number and percentage along with two-sided 95% Pearson-Clopper CI. The overall response rate was assessed utilizing the RECIST v. 1.1. CR: disappearance of all target and non-target lesions (TLs) and normalization of tumor markers. Pathological lymph nodes must have short axis measures less than (<) 10 millimeter (mm). PR: at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of TLs, taking as reference the baseline sum of diameters.|From the date of registration until the disease progression or death (up to 1541 days)|Efficacy analysis population included all participants who received at least one dose of study treatment and with at least one efficacy assessment.||percentage of participants||95% Confidence Interval|Number
827638|NCT01201265|Primary|Progression-free Survival (PFS)|Progression free survival (PFS) was calculated in days from the date of registration until the earliest date of documented disease progression or death. The median PFS time with 95% confidence interval (CI) was estimated using Kaplan Meier method. The progression-free survival was assessed utilizing computer tomography (CT)/ magnetic resonance imaging (MRI)/bone scans and X-ray and Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1. Progression of disease is defined as at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.|From the date of registration until the disease progression or death (up to 1541 days).|Efficacy analysis population included all participants who received at least one dose of study treatment and with at least one efficacy assessment||days||95% Confidence Interval|Median
827639|NCT01201317|Secondary|Change From Baseline to Day 29 in Neuropathic Pain Symptom Inventory Scale (NPSI) Total Score.|Last Observation carried Forward (LOCF). Scale consists of 10 Neuropathic Pain Symptom Inventory Scale (NPSI) pain symptom descriptors wiht a recall period of 24 hours. Each descriptor is rated on a Numerical Rating Scale (NRS) 0-10; 0=No (symptom), 10=Worst (symptom) imaginable. The NPSI Total Score was calculated as the sum of 10 of the NPSI descriptors. Range for total score 0 -100. Higher total score implicates worse symptoms.|Baseline (Day 1) to Day 29 (Visit 7)|Modified Intention- to- treat set (ITT) including only patients with adequate baseline and Day 29 data||Scores on a scale||Standard Deviation|Mean
827640|NCT01201317|Secondary|Number of Participants With at Least 50% Decrease From Baseline in Numerical Rating Scale (NRS) Average Pain Score at Day 28.|"Last Observation Carried Forward (LOCF). Numerical Rating Scale (NRS) Average Pain score reduction=(change from baseline at Day 28/baseline)*100.
Responder= NRS Average Pain score reduction ≥50% (yes/no)"|Baseline (mean of Day -5 to Day -1) to Day 28|Intention-to-treat set (ITT)||Participants|||Number
827641|NCT01201317|Secondary|Number of Participants With at Least 30% Decrease From Baseline in Numerical Rating Scale (NRS) Average Pain Score at Day 28.|"Last Observation Carried Forward (LOCF). Numerical Rating Scale(NRS) Average Pain score reduction=(change from baseline at Day 28/baseline)*100.
Responder= NRS Average Pain score reduction ≥30% (yes/no)"|Baseline (mean of Day -5 to Day -1) to Day 28|Intention-to-treat set (ITT)||Participants|||Number
836872|NCT01301079|Primary|Pain 210 Minutes|The scale measure pain after 210 minutes (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10.|210 minutes|||units on a scale||Standard Deviation|Mean
827645|NCT01201343|Secondary|Change From Baseline in Center for State-trait Anger Expression Inventory 2 (STAXI-state) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24|STAXI-state scale measures the intensity of anger as an emotional state (state anger) and the disposition to experience angry feelings as a personality trait (trait anger). In this study only 1 of the original 6 scales was used, the state anger scale, which measures the intensity of anger at a given moment as emotional state. This scale consists of 15 items graded in 4 degrees from 1 (not at all) to 4 (very much), where 4 corresponds to the worst state. The total score range from 1 (not at all) to 60 (very much), where 60 corresponds to the worst state. (Spielberger CD, 1996)|Baseline, Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24|ITT population: all participants with at least 1 interferon-beta intake and 1 evaluation of primary criterion, that is, at least 1 evaluation before treatment initiation and after Day 0 for emotional dyscontrol sub-score. 'n' signifies those participants who were evaluated for this measure at that time point.||units on a scale||Standard Deviation|Mean
827646|NCT01201343|Secondary|Change From Baseline in Center for Epidemiologic Studies Depression (CES-D) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24|CES-D is an auto-questionnaire including 20 items to screen for depressive feelings and behaviour. The 20 items of this scale are graded from 0 (never) to 3 (always), where 3 corresponds to the most severe state with the exception of items 4, 8, 12 and 16 (scoring was reversed before the calculation of the total score). Total score ranged from 0 (never) to 60 (always), where 60 corresponds to most severe state. (Radloff LS, 1977)|Baseline, Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24|ITT population: all participants with at least 1 interferon-beta intake and 1 evaluation of primary criterion, that is, at least 1 evaluation before treatment initiation and after Day 0 for emotional dyscontrol sub-score. 'n' signifies those participants who were evaluated for this measure at that time point.||units on a scale||Standard Deviation|Mean
827647|NCT01201343|Secondary|Change From Baseline in State-trait Anxiety Inventory (STAI State) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24|STAI state scale is an auto-evaluation scale for anxiety. This scale includes 20 items that allow quantifying feeling of apprehension, tension, nervousness and worry that the participant feels at the time of the completion of the questionnaire. The 20 items are graded from 1 (no) to 4 (yes), where 'yes' corresponds to the best state for items 1, 2, 5, 8, 10, 11, 15, 16, 19, 20 (scoring was reversed before calculation of total score); and to the worst state for items 3, 4, 6, 7, 9, 12, 13, 14, 17, 18. The total score ranged from 1 (best state) to 80 (worst state). (Spielberger CD et al., 1983)|Baseline, Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24|ITT population: all participants with at least 1 interferon-beta intake and 1 evaluation of primary criterion, that is, at least 1 evaluation before treatment initiation and after Day 0 for emotional dyscontrol sub-score. 'n' signifies those participants who were evaluated for this measure at that time point.||units on a scale||Standard Deviation|Mean
827648|NCT01201343|Secondary|Change From Baseline in Emotional Abrasion Sub-score of the EHD Scale at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24|EHD scale is a tool to assess the depressive mood dimensions 'lack of emotional control' (emotional dyscontrol) and 'blunted effect' which comprises of 11 items graded in 4 degrees from 1 (not at all) to 4 (very much), where 4 corresponds to the worst state. The emotional abrasion sub-score is the sum of items 3, 6, 7, and 8. The total possible score range from 1 (not at all) to 16 (very much), where 16 corresponds to worst state. (Radat F et al., 2007)|Baseline, Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24|ITT population: all participants with at least 1 interferon-beta intake and 1 evaluation of primary criterion, that is, at least 1 evaluation before treatment initiation and after Day 0 for emotional dyscontrol sub-score. 'n' signifies those participants who were evaluated for this measure at that time point.||units on a scale||Standard Deviation|Mean
827649|NCT01201343|Primary|Change From Baseline in Emotional Dyscontrol Sub-score of the EHD Scale at Month 24|EHD scale is a tool to assess the depressive mood dimensions 'lack of emotional control' (emotional dyscontrol) and 'blunted effect' which comprises of 11 items graded in 4 degrees from 1 (not at all) to 4 (very much), where 4 corresponds to the worst state. The emotional dyscontrol sub-score is the sum of items 1, 2, 4, 5, 9, 10, and 11. The total possible score range from 1 (not at all) to 28 (very much), where 28 corresponds to worst state. (Radat F et al., 2007)|Baseline and Month 24|ITT population: all participants with at least 1 interferon-beta intake and 1 evaluation of primary criterion, that is, at least 1 evaluation before treatment initiation and after Day 0 for emotional dyscontrol sub-score. 'N' (number of participants analyzed) signifies those participants who were evaluated for this measure at that time-point.||units on a scale||Standard Deviation|Mean
827650|NCT01201343|Primary|Change From Baseline in Emotional Dyscontrol Sub-score of the EHD Scale at Month 18|EHD scale is a tool to assess the depressive mood dimensions 'lack of emotional control' (emotional dyscontrol) and 'blunted effect' which comprises of 11 items graded in 4 degrees from 1 (not at all) to 4 (very much), where 4 corresponds to the worst state. The emotional dyscontrol sub-score is the sum of items 1, 2, 4, 5, 9, 10, and 11. The total possible score range from 1 (not at all) to 28 (very much), where 28 corresponds to worst state. (Radat F et al., 2007)|Baseline and Month 18|ITT population: all participants with at least 1 interferon-beta intake and 1 evaluation of primary criterion, that is, at least 1 evaluation before treatment initiation and after Day 0 for emotional dyscontrol sub-score. 'N' (number of participants analyzed) signifies those participants who were evaluated for this measure at that time-point.||units on a scale||Standard Deviation|Mean
827651|NCT01201343|Primary|Change From Baseline in Emotional Dyscontrol Sub-score of the Depressive Mood Scale (Echelle d'Humeur Depressive [EHD]) Scale at Month 12|EHD scale is a tool to assess the depressive mood dimensions 'lack of emotional control' (emotional dyscontrol) and 'blunted effect' which comprises of 11 items graded in 4 degrees from 1 (not at all) to 4 (very much), where 4 corresponds to the worst state. The emotional dyscontrol sub-score is the sum of items 1, 2, 4, 5, 9, 10, and 11. The total possible score range from 1 (not at all) to 28 (very much), where 28 corresponds to worst state. (Radat F et al., 2007)|Baseline and Month 12|Intent-to-treat (ITT) population: all participants with at least 1 interferon-beta intake and 1 evaluation of primary criterion, that is, at least 1 evaluation before treatment initiation and after Day 0 for emotional dyscontrol sub-score. 'n' signifies those participants who were evaluated for this measure at that time point.||units on a scale||Standard Deviation|Mean
827742|NCT01209702|Secondary|Part 2: Peak Plasma Concentration of Tocilizumab|The peak plasma concentration (Cmax) of tocilizumab at steady state after 12 weeks of treatment.|Week 12, pre-dose and at the end of infusion, on the 2nd and 7th day of Week 12, 14 days post-dose (Week 14) and 28 days post-dose (pre-dose of Week 16 infusion).|Due to premature study termination pharmacokinetic parameters were not analyzed.|||||
827654|NCT01208337|Secondary|Incidence of Patients in Whom Steroids Are Not Used|As part of analysis for assessing effectiveness and safety of Alemtuzumab Induction at the time of transplant, it is important to assess the incidence in which patients enrolled were able to wean off of steroids post-transplant compared to historical controls.|1 year|Induction of Alemtuzumab at time of transplant may increase the likelihood of weaning off steroids sooner after transplant than patients who did not receive Alemtuzumab as induction immunosuppression medication.||participants|||Number
827655|NCT01208337|Secondary|Incidence of Biopsy-proven Acute Cellular Rejection|Biopsy-proven incidence of acute cellular rejection|1 Year|Alemtuzumab induction at the time of transplant may reduce the rate of early acute cellular rejection compared with historical controls, but may increase rate of alternate post-transplant complications, such as Post Transplant Lymphoproliferative Disorder (PTLD).||participants|||Number
827656|NCT01208337|Primary|Incidence of Post Transplant Lymphoproliferative Disorder (PTLD)|Asses safety of Alemtuzumab in combination with Tacrolimus and steroids in twenty-three pediatric intestine allograft recipients by calculating the rate in which PTLD occurred amongst the study population.|5 Year|Alemtuzumab induction at the time of transplant may reduce the rate of early acute cellular rejection compared with historical controls, but may increase rate of alternate post-transplant complications, such as Post Transplant Lymphoproliferative Disorder (PTLD).||participants|||Number
827657|NCT01208402|Secondary|Percentage of Postoperative Hours 4 to 12 With Systolic Blood Pressure <95 mmHg|Duration of postoperative hours 4 to 12 patient was not in the target window of SBP > 95 mmHg, expressed as percent of the total 9 hours. SBP was measured during hours four and five at 30 minute intervals and once every hour for the next 7 hours, through 12 hours postoperatively.|Postoperative hours 4-12|Specific vital sign measurements were available for calculation of outcomes during the final 9 hours postoperatively in 18 cases in the Long-Acting BB group and in 16 cases in the Esmolol group.||percentage of 8 hour interval||Inter-Quartile Range|Median
827658|NCT01208402|Primary|Percentage of Postoperative Hours 4 to 12 With Heart Rate (HR) <60 or >80 Bpm.|Duration of postoperative hours 4 to 12 spent outside Target HR range defined as 60 to 80 bpm, expressed as percent of the total 9 hours. Vital signs are measured during hours four and five at 30 minute intervals and once every hour for the next 7 hours, through 12 hours postoperatively.|Postoperative hours 4-12|Specific vital sign measurements were available for calculation of outcomes during the final 9 hours postoperatively in 18 cases in the Long-Acting beta blocker group and in 16 cases in the Esmolol group.||percentage of 8 hour interval||Inter-Quartile Range|Median
827659|NCT01208402|Secondary|Percentage of Postoperative First Three Hours With Systolic Blood Pressure <95 mmHg|Duration of postoperative first three hours patient was not in the target window of SBP > 95 mmHg, expressed as percent of the total 3 hours. SBP is measured from end of surgery to 3 hours postoperatively at 5 minute intervals for first hour and every 15 minutes thereafter.|end of surgery to 3 hours|Ten cases (7 in the oral long acting beta blocker group and 3 in the Esmolol infusion group) were missing some of the postoperative vital sign measurements, resulting in gaps too long for valid calculation of the postoperative outcomes only.||percentage of 3 hour interval||Inter-Quartile Range|Median
827660|NCT01208402|Primary|Percentage of Postoperative First Three Hours With Heart Rate (HR) <60 or >80 Bpm|Duration of postoperative first three hours spent outside Target HR range defined as 60 to 80 bpm, expressed as percent of the total 3 hours. Vital signs are measured from end of surgery to 3 hours postoperatively at 5 minute intervals for the first hour and every 15 minutes thereafter.|End of surgery to 3 hours|Ten cases (7 in the oral long acting beta blocker group and 3 in the Esmolol infusion group) were missing some of the postoperative vital sign measurements, resulting in gaps too long for valid calculation of the postoperative outcomes only.||percentage of 3 hour interval||Inter-Quartile Range|Median
827661|NCT01208402|Secondary|Percentage of Intraoperative Case Time With Systolic Blood Pressure <95 mmHg|Duration of intraoperative case time patient was not in the target window of SBP > 95 mmHg, expressed as percent of total case minutes. SBP is measured from start of surgery to end of surgery at 5 minute intervals or less.|Start of surgery to end of surgery, an average duration of 245 minutes|Three enrolled cases (1 in the oral long acting beta blocker group and 2 in the Esmolol infusion group) were excluded from calculations a priori because they received diltiazem, a calcium channel blocker which lowers heart rate, before the operation.||percentage of surgery minutes||Inter-Quartile Range|Median
827662|NCT01208402|Primary|Percentage of Intraoperative Case Time With Heart Rate (HR) <60 or >80 Bpm|Duration of intraoperative excursion (ie, time spent) outside Target HR range defined as 60 to 80 bpm during surgery, expressed as percent of case minutes. Vital signs are measured from start of surgery to end of surgery at 5 minute intervals or less.|Start of surgery to end of surgery, an average duration of 245 minutes|Three enrolled cases (1 in the oral long acting beta blocker group and 2 in the Esmolol infusion group) were excluded from calculations a priori because they received diltiazem, a calcium channel blocker which lowers heart rate, before the operation.||percentage of case minutes||Inter-Quartile Range|Median
827663|NCT01208415|Primary|Patients That Are Free From Patency-related Intervention|Patency-related intervention is defined as: Secondary intervention to treat a > 60% stenosis of the internal iliac artery (as identified through CT, angiography, or duplex ultrasound and confirmed by core laboratory) associated with clinical symptoms. Of note, this not only includes patients with internal iliac artery stenosis following successful placement of the Zenith® Branch Endovascular Graft-Iliac Bifurcation and ConnectSX™, but also any cases of technical failure resulting in occlusion of the internal iliac artery during the initial implant procedure that require secondary intervention for associated clinical symptoms.|6 Months|Of the 37 patients available for analysis at 6 months, data was available for 34 patients.||participants|||Number
827693|NCT01209286|Secondary|Relapse-free Survival|Relapse-free survival was measured only for participants who achieved a CR or CRh* during the core study and was measured from the time the participant first achieved remission until first documented relapse or death due to any cause. Participants without a documented relapse (hematological or extramedullary) or who did not die were censored at the time of their last bone marrow assessment or their last survival follow-up visit confirming remission. Relapse-free survival was estimated using Kaplan-Meier methods.|Up to the data cut-off date of 15 October 2012; maximum follow up time was 459 days.|Participants who reached complete remission or complete remission with partial hematological recovery during the core study.||days||95% Confidence Interval|Median
827785|NCT01210170|Primary|Albuterol-induced Change in FEV1|FEV1 will be measured before and after inhalation of 180 mcg albuterol.|15 minutes after albuterol inhalation|||liters||Standard Error|Mean
827664|NCT01208870|Secondary|Changes in Variety Measures|Variety of high energy density foods (RED) and low energy density foods (GREEN) were calculated from the Food Frequency Questionnaire (FFQ) for pilot 1 and 24 hour recalls (24-HR) for pilot 2. High energy dense food or Red foods are low in nutrient density. Most Red foods come from the Fats, Oils and Sweets groups and are to be used sparingly. Modified foods from the Fats, Oils, and Sweets group are still considered to be Red foods, even if their energy level is low. These foods contribute little nutrients to the diet and compete for consumption of healthier foods. Green foods are high in nutrient density and low in energy density. Most Green foods come from the fruit and vegetable groups. Serving sizes were based off the serving sizes used in United States Department of Agriculture (USDA) common serving sizes. Coding was based on the serving sizes of the specified food items and used to calculate the changes from baseline to six months.|Baseline to 6 months|Parents and children were measured, three families did not complete the dietary measures.||food items||Standard Deviation|Mean
827665|NCT01208870|Secondary|Change in Child Delay Discounting|Kirby, small, medium and large reinforcers. The Kirby monetary choice questionnaire will be used to measure impulsivity in parents and children. Participants are presented with a set of 27 choices between smaller immediate rewards and larger delayed rewards. An estimate of the participant’s discounting rate parameter can be made from the pattern of choices and participants who discount the value of the delayed rewards more steeply are said to be more impulsive as measured in higher K-values (0.25 vs 0.00016).|Baseline to 6 months|Children that completed this measure at pre and post time points. Eleven children did not complete the post measure.||k value||Standard Deviation|Mean
827666|NCT01208870|Secondary|Change in Parent Delay Discounting|Kirby, small, medium and large reinforcers. The Kirby monetary choice questionnaire will be used to measure implusivity in parents and children. Participants are presented with a set of 27 choices between smaller immediate rewards and larger delayed rewards. An estimate of the participant’s discounting rate parameter can be made from the pattern of choices and participants who discount the value of the delayed rewards more steeply are said to be more impulsive as measured in K-values. (0.25 impulsive to 0.00016 not impulsive)|Baseline to 6 months|Parents that completed this measure pre and post. Ten parents did not complete this post measure.||k value||Standard Deviation|Mean
827667|NCT01208870|Primary|Change Parent Body Composition|Parent Body Mass Index (kg/m^2) difference from baseline to 6 months|Baseline to 6 months|Parents||kg/m^2||Standard Deviation|Mean
827668|NCT01208870|Secondary|Change in Dietary Intake of Calories|Energy intake was calculated for parents and children as the different from baseline to six months of calories consumed. The first pilot used the calories generated from the Food Frequency Questionnaire (FFQ) report however the second pilot used calories from 24 hour recalls based on the Center of Disease Control data base or food labels.|Baseline to 6 months|Parents and children, three families did not complete the dietary measures.||calories||Standard Deviation|Mean
827669|NCT01208870|Primary|Change of Child Body Composition|Child percent overweight difference from baseline to 6 month. The formula used to derive weight loss percentage was weight lost at 6 months divided by starting weight, multiplied by 100.|Baseline to 6 months|Children that completed the reported measures. Two children did not complete the body composition measures from the experimental groups and four children from the control group did not complete this measure.||percentage of weight||Standard Error|Mean
827670|NCT01208961|Primary|C(Max): Maximum Plasma Concentration|Analyses of the outcome measures presented are for baseline-adjusted data for total (esterified and unesterfied) EPA and DHA since the presence of endogenous levels of these fatty acids would likely contribute to intra-subject variability and affect the analyses and interpretation.|Blood samples were obtained pre-dose at -1.0, -0.5, and 0 hours and after dose administration at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 and 24 hours.|||nmol/mL||Full Range|Geometric Mean
827671|NCT01208961|Primary|AUC(Inf): Area Under the Plasma Concentration-time Curve From 0 to Infinity|Analyses of the outcome measures presented are for baseline-adjusted data for total (esterified and unesterfied) EPA and DHA since the presence of endogenous levels of these fatty acids would likely contribute to intra-subject variability and affect the analyses and interpretation.|Blood samples were obtained pre-dose at -1.0, -0.5, and 0 hours and after dose administration at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 and 24 hours.|||nmol.h/mL||Full Range|Geometric Mean
827672|NCT01208961|Primary|AUC(0-t): Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (the Final Time With a Concentration ≥ LOQ)|Analyses of the outcome measures presented are for baseline-adjusted data for total (esterified and unesterfied) EPA and DHA since the presence of endogenous levels of these fatty acids would likely contribute to intra-subject variability and affect the analyses and interpretation.|Blood samples were obtained pre-dose at -1.0, -0.5, and 0 hours and after dose administration at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 and 24 hours.|||nmol.h/mL||Full Range|Geometric Mean
827673|NCT01209143|Primary|Geometric Mean Ratio of the Maximum Plasma Concentration (Cmax) of Ethinyl Estradiol and Norethindrone|On Days 1 and 8, blood samples were taken prior to the administration of the contraceptive norethindrone 1 mg/ethinyl estradiol 35 µg (Ortho-Novum 1/35®) and 30 minutes, and 1, 2, 3, 4, and 6 hours, between 8 and 12 hours, and 24 hours post-dose. Plasma concentrations of ethinyl estradiol and norethindrone were determined using a validated liquid chromatography mass spectrometry/mass spectrometry (LC MS/MS) assay. Individual and mean plasma ethinyl estradiol and norethindrone concentration versus time data were tabulated and plotted by analyte. The pharmacokinetic parameters of each analyte were calculated using standard non-compartmental methods (WinNonlin version 5.2.1, Pharsight Corp., Mountain View, CA). The geometric mean ratios of Cmax of ethinyl estradiol and norethindrone were defined as the ratios of Cmax of ethinyl estradiol and norethindrone on Day 8 divided by Cmax of ethinyl estradiol and norethindrone on Day 1, respectively.|Pre-dose and 30 minutes, and 1, 2, 3, 4, and 6 hours, between 8 and 12 hours, and 24 hours post-dose|Pharmacokinetic population: All participants with pharmacokinetic data on Day 1 and Day 8.||ng/mL||90% Confidence Interval|Number
827715|NCT01209624|Primary|Change From Baseline in Heidelberg Retina Tomograph (HRT) Parameters: Mean RNFL Thickness|Mean retinal nerve fiber layer (RNFL) thickness in millimeters (mm) right and left eye assessed by HRT imaging. Valid range: 0.100 to 0.400 mm. Only the RNFL for the eye treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed.|Baseline, Month 6, Month 12, Month 18, Month 24, Last Visit|PP; n = number of participants with a non-missing response at both visits (baseline and observation). Last Visit = last post-baseline visit at which participant provides a value for RNFL thickness.||mm||Standard Deviation|Mean
827674|NCT01209143|Primary|Geometric Mean Ratio of the Area Under the Plasma Concentration-time Curve From 0 to Infinity (AUC[0-inf]) of Ethinyl Estradiol and Norethindrone|On Days 1 and 8, blood samples were taken prior to the administration of the contraceptive norethindrone 1 mg/ethinyl estradiol 35 µg (Ortho-Novum 1/35®) and 30 minutes, and 1, 2, 3, 4, and 6 hours, between 8 and 12 hours, and 24 hours post-dose. Plasma concentrations of ethinyl estradiol and norethindrone were determined using a validated liquid chromatography mass spectrometry/mass spectrometry (LC MS/MS) assay. Individual and mean plasma ethinyl estradiol and norethindrone concentration versus time data were tabulated and plotted by analyte. The pharmacokinetic parameters of each analyte were calculated using standard non-compartmental methods (WinNonlin version 5.2.1, Pharsight Corp., Mountain View, CA). The geometric mean ratios of AUC(0-inf) of ethinyl estradiol and norethindrone were defined as the ratios of AUC(0-inf) of ethinyl estradiol and norethindrone on Day 8 divided by AUC(0-inf) of ethinyl estradiol and norethindrone on Day 1, respectively.|Pre-dose and 30 minutes, and 1, 2, 3, 4, and 6 hours, between 8 and 12 hours, and 24 hours post-dose|Pharmacokinetic population: All participants with pharmacokinetic data on Day 1 and Day 8.||ng/mL*hr||90% Confidence Interval|Number
827675|NCT01209143|Primary|Geometric Mean Ratio of the Maximum Plasma Concentration (Cmax) of Rosiglitazone|On Days 1 and 8, blood samples were taken prior to the administration of rosiglitazone and 30 minutes, and 1, 2, 3, 4, and 6 hours, between 8 and 12 hours, and 24 hours post-dose. Plasma concentrations of rosiglitazone were determined using a validated liquid chromatography mass spectrometry/mass spectrometry (LC MS/MS) assay. Individual and mean plasma rosiglitazone concentration versus time data were tabulated and plotted by analyte. The pharmacokinetic parameters of each analyte were calculated using standard non-compartmental methods (WinNonlin version 5.2.1, Pharsight Corp., Mountain View, CA). The geometric mean ratio of Cmax of rosiglitazone was defined as the Cmax of rosiglitazone on Day 8/ Cmax of rosiglitazone on Day 1.|Pre-dose and 30 minutes, and 1, 2, 3, 4, and 6 hours, between 8 and 12 hours, and 24 hours post-dose|Pharmacokinetic population: All participants with pharmacokinetic data on Day 1 and Day 8.||ng/mL||90% Confidence Interval|Number
827676|NCT01209143|Primary|Geometric Mean Ratio of the Area Under the Plasma Concentration-time Curve From 0 to Infinity (AUC[0-inf]) of Rosiglitazone|On Days 1 and 8, blood samples were taken prior to the administration of rosiglitazone and 30 minutes, and 1, 2, 3, 4, and 6 hours, between 8 and 12 hours, and 24 hours post-dose. Plasma concentrations of rosiglitazone were determined using a validated liquid chromatography mass spectrometry/mass spectrometry (LC MS/MS) assay. Individual and mean plasma rosiglitazone concentration versus time data were tabulated and plotted by analyte. The pharmacokinetic parameters of each analyte were calculated using standard non-compartmental methods (WinNonlin version 5.2.1, Pharsight Corp., Mountain View, CA). The geometric mean ratio of AUC(0-inf) of rosiglitazone was defined as the AUC(0-inf) of rosiglitazone on Day 8/AUC(0-inf) of rosiglitazone on Day 1.|Pre-dose and 30 minutes, and 1, 2, 3, 4, and 6 hours, between 8 and 12 hours, and 24 hours post-dose|Pharmacokinetic population: All participants with pharmacokinetic data on Day 1 and Day 8.||ng/mL*hr||90% Confidence Interval|Number
827677|NCT01209195|Secondary|Immunogenicity|Samples were collected to determine the presence of an immunologic reaction to MM-121 (i.e. human anti-human antibodies).|Samples were collected for all patients pre-dose on all cycles for duration of treatment, the longest of which was 163 weeks, and a collection was made post-infusion in any case of infusion reaction||||||Number
827678|NCT01209195|Secondary|Pharmacokinetic Parameters (AUClast)|"Pharmacokinetic (PK) evaluation was performed on plasma samples obtained weekly for the first cycle of the study and then on day 1 of each additional cycle to assess pre-treatment trough concentrations of MM-121. Non-compartmental analysis (NCA) was performed to calculate standard PK parameters, including the maximum observed concentration (Cmax). Serum levels of MM-121 were measured at a central lab using an enzyme-linked immunosorbent assay (ELISA). Data is presented per dose level of MM-121 (20/12 mg/kg weekly, 40/20 mg/kg weekly, 40 mg/kg Q2W, or 40/20 mg/kg QW x 7 plus a rest week).
Immunogenicity data is not available."|Collections taken at for all patients at Cycle 1, Week 1 (pre-treatment/pre-infusion, at the end of the infusion, and 2.5, 4, 6 and 24 hours after starting the infusion of MM-121) and pre-treatment at Cycle 1, Week 3 and Cycle 2, Week 1|"All patients. Data presented per dose level of MM-121 and not per cohort. The same dose was used in multiple cohorts, and those data were combined.
NOTE: two patients are not included in the analysis due to incorrectly collected or processed samples."||hr* ug/mL||Geometric Coefficient of Variation|Geometric Mean
827679|NCT01209195|Secondary|To Determine the Pharmacokinetics (PK) of MM-121 When Administered in Combination With Paclitaxel|Pharmacokinetic (PK) evaluation was performed on plasma samples obtained weekly for the first cycle of the study and then on day 1 of each additional cycle to assess pre-treatment trough concentrations of MM-121. Non-compartmental analysis (NCA) was performed to calculate standard PK parameters, including the maximum observed concentration (Cmax). Serum levels of MM-121 were measured at a central lab using an enzyme-linked immunosorbent assay (ELISA). Data is presented per dose level of MM-121 (20/12 mg/kg weekly, 40/20 mg/kg weekly, 40 mg/kg Q2W, or 40/20 mg/kg QW x 7 plus a rest week).|Collections taken at for all patients at Cycle 1, Week 1 (pre-treatment/pre-infusion, at the end of the infusion, and 2.5, 4, 6 and 24 hours after starting the infusion of MM-121) and pre-treatment at Cycle 1, Week 3 and Cycle 2, Week 1|"All patients. Data presented per dose level of MM-121 and not per cohort. The same dose was used in multiple cohorts, and those data were combined.
NOTE: two patients are not included in the analysis due to incorrectly collected or processed samples."||ug/mL||Geometric Coefficient of Variation|Geometric Mean
827680|NCT01209195|Secondary|To Characterize the Efficacy of the Combination of MM-121 and Paclitaxel Using Objective Response Rate|To determine the number of patients reporting an objective response using RECIST v 1.1 where a Partial Response (PR) is defined as >20% decrease in tumor burden from baseline and a Complete Response (CR) is defined as complete disappearance from tumor burden from baseline. Objective Response is presented as the total # patients with PR or CR.|patients were assessed for response during their time on study, the longest of which was 163 weeks|||participants with objective response|||Number
827716|NCT01209624|Primary|Change From Baseline in Heidelberg Retina Tomograph Parameters: Cup Shape Measure|Cup shape measure right and left eye assessed by HRT imaging . Valid range: -0.400 to -0.010. Only the cup shape measure for the eye treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed.|Baseline, Month 6, Month 12, Month 18, Month 24, Last Visit|PP; n = number of participants with a non-missing response at both visits (baseline and observation). Last Visit = last post-baseline visit at which participant provides a value for cup shape measure.||Cup shape measure||Standard Deviation|Mean
827681|NCT01209195|Primary|To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Paclitaxel: Paclitaxel Dose Level|"Using a 3+3 dose escalation model, the maximum tolerated dose of each combination was determined by assessing dose-limiting toxicities in each cohort.
Part 1 Cohort 1: MM-121: 20 mg/kg loading dose followed by 12 mg/kg QW IV )20/12) + Paclitaxel: 80mg/m2 IV QW Part 1 Cohort 2: MM-121: 40 mg/kg loading dose followed by 20 mg/kg QW IV (40/20) + Paclitaxel: 80mg/m2 QW IV Part 2 Cohort 1: MM-121: 40/20 mg/kg IV + Paclitaxel: 80mg/m2 QW IV Part 2 Cohort 2: MM-121 20 /12 mg/kg IV QW + Paclitaxel: 80 mg/m2 QW IV Part 2 Cohort 3: MM-121 40mg/kg IV QOW + Paclitaxel: 80 mg/m2 QW IV Part 2 Cohort 4: MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV for 3 weeks, followed by one week of rest + Paclitaxel: 80mg/m2 weekly IV for 3 weeks, followed by one week of rest"|From date of first dose to 30 days after termination, the longest 163 weeks|note: MTD of MM-121 when administered in combination with paclitaxel provided in separate endpoint entry||mg/m2|||Number
827682|NCT01209195|Primary|To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Paclitaxel: MM-121 Dose Level|"Using a 3+3 dose escalation model, the maximum tolerated dose of each combination was determined by assessing dose-limiting toxicities in each cohort.
Part 1 Cohort 1: MM-121: 20 mg/kg loading dose followed by 12 mg/kg QW IV )20/12) + Paclitaxel: 80mg/m2 IV QW Part 1 Cohort 2: MM-121: 40 mg/kg loading dose followed by 20 mg/kg QW IV (40/20) + Paclitaxel: 80mg/m2 QW IV Part 2 Cohort 1: MM-121: 40/20 mg/kg IV + Paclitaxel: 80mg/m2 QW IV Part 2 Cohort 2: MM-121 20 /12 mg/kg IV QW + Paclitaxel: 80 mg/m2 QW IV Part 2 Cohort 3: MM-121 40mg/kg IV QOW + Paclitaxel: 80 mg/m2 QW IV Part 2 Cohort 4: MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV for 3 weeks, followed by one week of rest + Paclitaxel: 80mg/m2 weekly IV for 3 weeks, followed by one week of rest"|From date of first dose to 30 days after termination, the longest 163 weeks|NOTE: MTD of paclitaxel when administered with MM-121 provided in separate endpoint entry||mg/kg|||Number
827683|NCT01209195|Primary|Dose Escalation: To Evaluate the Safety and Tolerability of Escalating Doses of the MM-121 Plus Paclitaxel Combination Via Reporting of Dose-limiting Toxicity (DLT)|To establish the safety of escalating doses of MM-121 in combination with paclitaxel in order to determine the recommended phase 2 dose. Dose-escalation conducted using standard 3+3 model to determine maximum tolerated dose. Reports of Dose-Limiting Toxicities (DLTs) were assessed to determine the MTD.|From date of first dose to 30 days after termination, the longest 163 weeks|||participants reporting DLTs|||Number
827684|NCT01209260|Secondary|Plastic Dilator Shavings|In ex vivo pre-procedural testing, the assigned transseptal needle was advanced through the plastic dilator and sheath, and the presence of grossly visible plastic shavings after introduction of the needle through the dilator and long sheath was recorded.|immediately prior to procedure|The assigned needle for each participant was analyzed prior to the procedure||Needles|Participants||Number
827685|NCT01209260|Secondary|Performance of the Assigned Needle Type|Failure to achieve transseptal access with the assigned needle type resulted in crossover because of an inability to puncture the interatrial septem despite forward pressure and tenting, leading to concern that further effort might lead to perforation of the free (lateral) LA wall.|at time of procedure|||participants|||Number
827686|NCT01209260|Secondary|Number of Participants With Adverse Events as a Measure of Safety||During or immediately after procedure, up to 1 day after procedure. On average, up to 1 day after the procedure.|||participants|||Number
827687|NCT01209260|Primary|Transseptal Access Procedure Time|Total amount of procedure time, from the beginning of the transseptal procedure until left atrium (LA) access is obtained in each patient. Participants for whom puncture failed crossed over to the other Intervention. Analysis performed on an intention-to-treat basis.|Day of procedure|||minutes||Inter-Quartile Range|Median
827688|NCT01209286|Secondary|Serum Cytokine Peak Levels|The activation of immune effector cells was monitored by the measurement of peripheral blood cytokine levels including interleukin (IL)-2, IL-6, IL-10, tumor necrosis factor (TNF)-α and interferon gamma (IFN-γ) using multiplex cytometric bead assays. The lower limit of quantification (LLOQ) is 125 pg/mL and the limit of detection (LOD) is 20 pg/mL.|Samples were collected prior to treatment start (baseline), and at 2, 6, 24, and 48 hours after drug infusion start, and at these same time points when dose is escalated in each treatment cycle.|Participants who received blinatumomab and who had evaluable pharmacodynamic data.||pg/mL||Standard Deviation|Mean
827689|NCT01209286|Secondary|Clearance of Blinatumomab|Clearance was calculated as R0/Css; where R0 is the infusion rate (μg/m^2/hr) and Css is the steady state concentration.|Samples were collected at predose and at 48 hours following start of infusion, when dose is escalated and on Days 8, 15, 22, and 29 of the first 2 cycles.|Participants who received blinatumomab and who had available pharmacokinetic data.||L/m^2/hr||Standard Deviation|Mean
827690|NCT01209286|Secondary|Steady State Blinatumomab Concentration|"The steady state concentration of blinatumomab was summarized as the observed concentrations collected at least 10 hours after the intravenous infusion was started for cycle 1 and cycle 2, respectively. Actual doses administered were used in the analysis.
Concentrations below the limit of detection (3 pg/mL) were set to zero before data analysis and concentrations below the lower limit of quantitation (50 pg/mL) were excluded from analysis."|Samples were collected at predose and at 48 hours following start of infusion, when dose is escalated and on Days 8, 15, 22, and 29 of the first 2 cycles.|Participants who received blinatumomab and who had available pharmacokinetic data.||pg/mL||Standard Deviation|Mean
827691|NCT01209286|Secondary|Number of Participants With Treatment-emergent Adverse Events|"Adverse events were evaluated for severity according to the grading scale provided in the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 and according to the following:
Grade I (mild); Grade 2 (moderate); Grade 3 (severe - significantly limits the patient's ability to perform routine activities despite symptomatic therapy; Grade 4 (life-threatening); Grade 5 (death).
The investigator used medical judgment to determine if there was a causal relationship (ie, certain, probable, possible, unlikely, not related) between an adverse event and blinatumomab.
A serious adverse event is any untoward medical occurrence or effect, that at any dose:
resulted in death, was life-threatening, required or prolonged hospitalization, resulted in persistent or significant disability or incapacity, is a congenital anomaly or birth defect or is a medically important condition."|From the start of the first infusion to 30 days after the end of the last infusion in the core study or from the start of the first retreatment cycle infusion to 30 days after the end of the last retreatment cycle; median treatment duration was 55.7 days.|Safety analysis set, defined as all participants who received any infusion of blinatumomab.||participants|||Number
827694|NCT01209286|Secondary|Time to Hematological Relapse|"Time to hematological relapse was measured for participants who achieved a CR or CRh* during the core study and was measured from the time the participant first achieved remission until first documented relapse or death due to disease progression. Participants without a documented relapse (hematological or extramedullary) and who did not die were censored at the time of their last bone marrow assessment or their last survival follow-up visit confirming remission. Participants who died without having reported hematological relapse or without showing any clinical sign of disease progression were censored on their day of death.
Hematological Relapse was defined as:
Proportion of blasts in bone marrow > 5%
Extramedullary relapse.
Time to hematological relapse was analyzed by Kaplan-Meier methods."|Up to the data cut-off date of 15 October 2012; maximum follow up time was 459 days.|Participants who reached complete remission or complete remission with partial hematological recovery during the core study.||days||95% Confidence Interval|Median
827695|NCT01209286|Secondary|Percentage of Participants Who Received an Allogeneic Hematopoietic Stem Cell Transplant (HSCT) After Treatment With Blinatumomab|The percentage of participants who underwent immediate allogeneic HSCT (defined as those in remission who undergo HSCT without receiving any other treatments) after having discontinued or completed the core study.|Up to the data cut-off date of 15 October 2012; maximum follow up time was 459 days|Full analysis set||percentage of participants|||Number
827696|NCT01209286|Secondary|Percentage of Participants With a Minimal Residual Disease (MRD) Response During the Core Study|A minimal residual disease (MRD) response is defined as MRD < 10^-4 blasts/nucleated cells based on polymerase chain reaction (PCR) evaluation of individual rearrangements of immunoglobulin or T cell receptor genes.|During the core study treatment period (up to 30 weeks).|Full analysis set (FAS)||percentage of participants||95% Confidence Interval|Number
827697|NCT01209286|Secondary|Percentage of Participants With a Best Response of Partial Remission Within 2 Cycles of Treatment|"At the end of each infusion period, a bone marrow aspiration/biopsy was performed to evaluate the efficacy of blinatumomab. All hematological assessments of bone marrow were reviewed in a central reference laboratory. Partial remission was defined by the following criteria:
• Bone marrow blasts ≤ 25%"|Within the first 2 cycles of treatment, 12 weeks|Full analysis set||percentage of participants||95% Confidence Interval|Number
827698|NCT01209286|Secondary|Percentage of Participants With a Best Response of Complete Remission With Only Partial Hematological Recovery Within 2 Cycles of Treatment|"At the end of each infusion period, a bone marrow aspiration/biopsy was performed to evaluate the efficacy of blinatumomab. All hematological assessments of bone marrow were reviewed in a central reference laboratory. Complete remission with only partial hematological recovery (CRh*) was defined by the following criteria:
Less than or equal to 5% blasts in the bone marrow
No evidence of circulating blasts or extramedullar disease
Partial recovery of peripheral blood counts:
Platelets > 50,000/μL
Hemoglobin ≥ 7 g/dL
ANC > 500/μL."|Within the first 2 cycles of treatment, 12 weeks|Full analysis set||percentage of participants||95% Confidence Interval|Number
827699|NCT01209286|Secondary|Percentage of Participants With a Best Response of Complete Remission Within 2 Cycles of Treatment|"At the end of each infusion period, a bone marrow aspiration/biopsy was performed to evaluate the efficacy of blinatumomab. All hematological assessments of bone marrow were reviewed in a central reference laboratory. Complete Response/Remission (CR) was defined by the following criteria:
Less than or equal to 5% blasts in the bone marrow
No evidence of circulating blasts or extramedullar disease
Full recovery of peripheral blood counts:
Platelets > 100,000/μL
Hemoglobin ≥ 11 g/dL
Absolute neutrophil count (ANC) > 1,500/μL"|Within the first 2 cycles of treatment, 12 weeks|Full analysis set||percentage of participants||95% Confidence Interval|Number
827700|NCT01209286|Primary|Percentage of Participants With a Best Response of Complete Remission or Complete Remission With Only Partial Hematological Recovery Within 2 Cycles of Treatment|"At the end of each infusion period, a bone marrow aspiration/biopsy was performed to evaluate the efficacy of blinatumomab. All hematological assessments of bone marrow were reviewed in a central reference laboratory. Hematological remissions were defined by the following criteria:
Complete Response/Remission (CR):
Less than or equal to 5% blasts in the bone marrow
No evidence of circulating blasts or extramedullar disease
Full recovery of peripheral blood counts:
Platelets > 100,000/μL
Hemoglobin ≥ 11 g/dL
Absolute neutrophil count (ANC) > 1,500/μL
Complete Remission with only Partial Hematological Recovery (CRh*):
Less than or equal to 5% blasts in the bone marrow
No evidence of circulating blasts or extramedullar disease
Partial recovery of peripheral blood counts:
Platelets > 50,000/μL
Hemoglobin ≥ 7 g/dL
ANC > 500/μL."|Within the first 2 cycles of treatment, 12 weeks|Full analysis set (FAS), defined as participants who received any infusion of the assigned study medication, who completed at least the first treatment cycle and for whom at least one response assessment was available after the start of treatment.||percentage of participants||95% Confidence Interval|Number
827701|NCT01209520|Primary|Degree of Demethylation in Patient Tumor Tissue and/or Serum Induced by 5-azacitidine on Specific Tumor Specific Genes (TSGs)|To measure the grade of demethylation induced by 5-azaciditine on specific TSGs by analyzing plasma DNA, and global demethylation by analyzing WBC DNA, and determine the duration of this effect.|Up to 2 years|Study data were not analyzed due to insufficient number of evaluable patients.|||||
827702|NCT01209520|Primary|Percentage of Patients Showing a Presence of Methylated Tumor Suppressor Genes in Their Tumor Tissue and/or Serum Achieving Partial or Complete Response to Protocol Therapy.|To determine the feasibility and efficacy of incorporating a demethylating agent (5-azacitidine; Vidaza®, Celgene, Summit, NJ, USA) as part of adjuvant therapy in patients diagnosed with NSCLC who harbor methylated tumor supressor genes (TSGs) in their tumor tissue and/or serum. Response to be evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.0.|Up to 2 years|Study data were not analyzed due to insufficient number of evaluable patients.|||||
827703|NCT01209624|Primary|Percentage of Participants With Progression of Visual Field|Progression defined as visual field deterioration rated progressive by physician on at least 1 post-baseline visit, and increase in Aulhorn stage (by at least 1 stage) and/or decrease in mean defect by at least 2.5 dB (Last Visit minus Baseline).|Month 24 (or last visit)|PP; to be included in the percentage, participants must have had Visual Field Deterioration rated as progressive by the physician on at least 1 post-baseline visit, and at least one measure of increase in Aulhorn Stage by at least 1 stage, and decrease in Mean Defect by at least 2 dB (last visit minus baseline).||Percentage of Participants|||Number
836873|NCT01301079|Primary|Pain 180 Minutes|The scale measure pain after 180 minutes (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10.|180 minutes|||units on a scale||Standard Deviation|Mean
827704|NCT01209624|Primary|Percentage of Participants With Progression of Optic Disc Excavation|Progression (Last Visit minus Baseline) defined as increase in horizontal cup to disc ratio and/or vertical cup to disc ratio by at least 0.2, and/or decrease in at least 1 of Heidelberg Retina Tomograph (HRT) parameters (deterioration of rim area 0.2 mm2; deterioration of rim volume 0.1 mm3 deterioration or mean retinal nerve fiber layer (RNFL) thickness 0.1 mm).|Month 24 (or last visit)|PP; to be included in the percentage, participants must have provided a response for at least one of following events: increase in horizontal or vertical cup to disc ratio, or decrease in rim area, rim volume, or mean RNFL thickness. Last Visit = last post-baseline visit at which participant provides a value for the relevant outcome measure.||Percentage of Participants|||Number
827705|NCT01209624|Primary|Percentage of Participants With Overall Progression of Glaucoma Damage|Overall progression defined as at least 1 of the 6 individual progression of glaucoma damage measures met: increase in horizontal cup to disc ratio and/or vertical cup to disc ratio by at least 0.2; at least 1 post Baseline (BL) optic-disc hemorrhage; decreased rim area (0.2 mm2), rim volume (0.1 mm3), mean retinal nerve fiber layer (RNFL)(0.1 mm), progressive visual field deterioration, increase in Aulhorn stage (by at least 1 stage), and/or decrease in mean defect by at least 2.5 decibels [dB])|Month 24 (or last visit)|PP; to be included in the percentage, participants must have provided a response for at least one of the six individual progression of glaucoma damage measures. Last Visit = last post-baseline visit at which participant provides a value for the relevant outcome measure.||Percentage of Participants|||Number
827706|NCT01209624|Primary|Number of Participants With Individual Progression of Glaucoma Damage: Mean Defect|Decrease in mean defect by at least 2.5 decibels (dB) (Last Visit minus Baseline).|Month 24 (or last visit)|PP; results based on participants with a value for mean defect at both Baseline and at least one post-baseline visit. Last Visit = last post-baseline visit at which participant provides a value for the relevant outcome measure.||Participants|||Number
827707|NCT01209624|Primary|Number of Participants With Individual Progression of Glaucoma Damage: Aulhorn Stage|Increase in Aulhorn Stage by at least one stage (last visit minus baseline). Three different visual field defect categories defined using Aulhorn stage values 1-5: Aulhorn stage 1 = mild damage, Aulhorn stages 2, 3 = moderate damage, Aulhorn stages 4, 5 =severe damage.|Month 24 (or last visit)|PP; results based on participants with a value for Aulhorn Stage at both Baseline and at least one post-baseline visit. Last Visit = last post-baseline visit at which participant provides a value for the relevant outcome measure.||Participants|||Number
827708|NCT01209624|Primary|Number of Participants With Individual Progression of Glaucoma Damage: Visual Field Defect-Deterioration|Visual Field Deterioration rated as progressive by physician on at least one post-baseline visit; range: 1= improved 2= stable 3= progressive. If both eyes were treated with Xalatan® the value for the right eye was used; otherwise, only the assessment for the eye treated with study medication was used.|Month 24 (or last visit)|PP; results based on participants with at least one post-baseline assessment of change in visual field defect. Last Visit = last post-baseline visit at which participant provides a value for the relevant outcome measure.||Participants|||Number
827709|NCT01209624|Primary|Number of Participants With Individual Progression of Glaucoma Damage: Rim Area, Rim Volume, or Mean Retinal Nerve Fiber Layer (RNFL) Thickness|Decrease in at least one Heidelberg Retina Tomograph (HRT) parameter by: Rim Area 0.2 millimeter (mm)2, Rim Volume 0.1 mm3, or mean retinal nerve fiber layer (RNFL) Thickness 0.1 mm, (Last Visit minus Baseline).|Month 24 (or last visit)|PP; results based on participants with a value of the variable in question at both Baseline and at least one post-baseline visit. Last Visit = last post-baseline visit at which participant provides a value for the relevant outcome measure.||Participants|||Number
827710|NCT01209624|Primary|Number of Participants With Individual Progression of Glaucoma Damage: Optic Disc Hemorrhage|Participants with at least one post-baseline optic disc hemorrhage.|Month 24 (or last visit)|PP; results based on participants with at least one post-baseline assessment of optic disc hemorrhage. Last Visit = last post-baseline visit at which participant provides a value for the relevant outcome measure.||Particpants|||Number
827711|NCT01209624|Primary|Number of Participants With Individual Progression of Glaucoma Damage: Horizontal Cup to Disc Ratio and/or Vertical Cup to Disc Ratio|Increase in Horizontal Cup to Disc Ratio and/or Vertical Cup to Disc Ratio by at least 0.2 (Last Visit minus Baseline).|Month 24 (or last visit)|PP; results based on participants with both a Baseline and at least one post-baseline visit. Last Visit = last post-baseline visit at which participant provides a value for the relevant outcome measure.||Participants|||Number
827712|NCT01209624|Primary|Number of Participants With Investigator Assessments of Efficacy at Month 24|Number of participants with Investigator assessments of the efficacy of Xalatan® treatment rated as: 1=very good, 2=good, 3=moderate, 4=insufficient. If study medication was stopped before 24 months, assessment was performed at the time of early termination.|Month 24|PP; N = number of participants with a non-missing response at Month 24 visit.||Participants|||Number
827713|NCT01209624|Primary|Number of Participants With Change From Baseline to Month 24 in Visual Field Defect|Change in mean defect right and left eye; valid range: -30 - + 30 decibels (dB). Visual field defect categories: preperimetric glaucoma: ≥ -2 dB; mild damage: < -2 dB and ≥ -3.3 dB; moderate damage: < -3.3 dB and ≥ -4.6 dB; and severe damage: < -4.6 dB. If both eyes were treated with Xalatan® , the value for the right eye was used; otherwise, only the mean defect value for the eye treated with study medication was used.|Baseline, Month 24|PP; N = number of participants who provided a Mean Defect value at both Baseline and Month 24 visits.||Participants|||Number
827714|NCT01209624|Primary|Number of Participants With Change From Baseline to Month 24 in Aulhorn Stages|Values of change in Aulhorn Stage measured by Humphrey Visual Field Analyzer. Aulhorn stages: no scotoma, Stage I (relative scotomas only), Stage II (absolute scotomas without connection to blind spot), Stage III (absolute scotomas with connection to blind spot), Stage IV (absolute scotomas more than 1 quadrant affected), and Stage V (temporal residual visual field only). If both eyes were treated with Xalantan® the value of right eye was analyzed; otherwise, only the assessment for the eye treated with study medication was used.|Baseline, Month 24|PP; N = number of participants who provided Aulhorn stage values of 1 to 5 at both baseline and month 24 visits.||Participants|||Number
827739|NCT01209702|Secondary|Part 2: Volume of Distribution of Tocilizumab|Volume of distribution of tocilizumab at steady state after 12 weeks of treatment.|Week 12, pre-dose and at the end of infusion, on the 2nd and 7th day of Week 12, 14 days post-dose (Week 14) and 28 days post-dose (pre-dose of Week 16 infusion).|Due to premature study termination pharmacokinetic parameters were not analyzed.|||||
827717|NCT01209624|Primary|Change From Baseline in Heidelberg Retina Tomograph (HRT) Parameters: Rim Volume|Rim volume (mm3) right and left eye assessed by HRT imaging. Valid range: 0.080 to 0.700 mm3. Only the rim volume for the eye treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed.|Baseline, Month 6, Month 12, Month 18, Month 24, Last Visit|PP; n = number of participants with a non-missing response at both visits (baseline and observation). Last Visit = last post-baseline visit at which participant provides a value for rim volume.||mm3||Standard Deviation|Mean
827718|NCT01209624|Primary|Change From Baseline in Heidelberg Retina Tomograph (HRT) Parameters: Rim Area|Rim area (millimeter [mm]2) right and left eye assessed by HRT imaging. Valid range: 0.500 to 1.900 mm2. Only the rim area for the eye treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed.|Baseline, Month 6, Month 12, Month 18, Month 24, Last Visit|PP; n = number of participants with a non-missing response at both visits (baseline and observation). Last Visit = last post-baseline visit at which participant provides a value for rim area.||mm2||Standard Deviation|Mean
827719|NCT01209624|Primary|Number of Participants With Optic Disc Hemorrhage by Visit: Month 24|Presence of optic disc hemorrhages assessed by slip lamp examination. Only data for eye were treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed.|Month 24|PP; N = number of participants who indicated whether or not they had an optic disc hemorrhage at the given visit.||Participants|||Number
827720|NCT01209624|Primary|Number of Participants With Optic Disc Hemorrhage by Visit: Month 18|Presence of optic disc hemorrhages assessed by slip lamp examination. Only data for eye were treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed.|Month 18|PP; N = number of participants who indicated whether or not they had an optic disc hemorrhage at the given visit.||Participants|||Number
827721|NCT01209624|Primary|Number of Participants With Optic Disc Hemorrhage by Visit: Month 12|Presence of optic disc hemorrhages assessed by slip lamp examination. Only data for eye were treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed.|Month 12|PP; N = number of participants who indicated whether or not they had an optic disc hemorrhage at the given visit.||Participants|||Number
827722|NCT01209624|Primary|Number of Participants With Optic Disc Hemorrhage by Visit: Month 6|Presence of optic disc hemorrhages assessed by slip lamp examination. Only data for eye were treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed.|Month 6|PP; N = number of participants who indicated whether or not they had an optic disc hemorrhage at the given visit.||Participants|||Number
827723|NCT01209624|Primary|Change From Baseline by Visit in Optic Disc Excavation: Vertical Cup to Disc Ratio|Mean vertical cup to disc (cup/disc or C/D) ratio measured by slit lamp examination to assess progression of glaucoma; calculated as the ratio of the diameter of the depression (cup) to that of the optical nerve head (disc). Valid range: 0.1-1.0; a high cup/disc ratio may imply glaucoma. Only data for the eye treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed.|Baseline, Month 6, Month 12, Month 18, Month 24, Last Visit|PP. N = number of participants with vertical cup to disc ratio at baseline and at least 1 post-baseline visit; change analyzed for participants with a non-missing response at baseline and observation. Last Visit: change in vertical cup to disc ratio in participants with a non-missing response at both baseline and at least one post-baseline visit.||Ratio||Standard Deviation|Mean
827724|NCT01209624|Primary|Change From Baseline by Visit in Optic Disc Excavation: Horizontal Cup to Disc Ratio|Mean horizontal cup to disc (cup/disc or C/D) ratio measured by slit lamp examination to assess progression of glaucoma; calculated as the ratio of the diameter of the depression (cup) to that of the optical nerve head (disc). Valid range: 0.1-1.0. Only data for the eye treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed.|Baseline, Month 6, Month 12, Month 18, Month 24, Last Visit|PP; N = number of participants with horizontal cup to disc ratio data at baseline and at least 1 post-baseline visit; change analyzed for participants with a non-missing response at baseline and observation. Last Visit: change in participants with a non-missing response at both baseline and at least one post-baseline visit.||Ratio||Standard Deviation|Mean
827725|NCT01209624|Primary|Percentage of Participants Who Achieved Intraocular Pressure (IOP) Target at Last Visit|Percentage of participants who achieved their IOP target set at baseline. Response: Yes = achieved IOP target at last vist; No = did not achieve IOP target at last visit.|Month 24, (or last visit)|PP; n = number of subjects in the Per Protocol Analysis Set with a non-missing response at Last Visit. Last visit = last post-baseline visit at which participant provides a value of IOP.||Percentage of Participants|||Number
827726|NCT01209624|Primary|Number of Participants Per Visit With Intraocular Pressure (IOP) 24-Hour Pressure Peaks: Month 24|Response: Yes = had IOP 24-hour pressure peak; No = did not have IOP 24-hour pressure peak.|Month 24|PP; N = number of participants with analyzable data at observation. The total number of participants by visit with an IOP peak response of ‘Yes’ differs from those with numerical values of IOP peaks since 1 of the 2 fields was populated for certain participants.||Participants|||Number
827727|NCT01209624|Primary|Number of Participants Per Visit With Intraocular Pressure (IOP) 24-Hour Pressure Peaks: Month 12|Response: Yes = had IOP 24-hour pressure peak; No = did not have IOP 24-hour pressure peak.|Month 12|PP; N = number of participants with analyzable data at observation. The total number of participants by visit with an IOP peak response of ‘Yes’ differs from those with numerical values of IOP peaks since 1 of the 2 fields was populated for certain participants.||Participants|||Number
827728|NCT01209624|Primary|Number of Participants With a 24-Hour Intraocular Pressure (IOP) Profile: Month 24|Response: Yes = had an IOP 24-hour profile; No = did not have an IOP 24-hour profile.|Month 24|PP; N = number of participants with analyzable data at observation.||Participants|||Number
827729|NCT01209624|Primary|Number of Participants With a 24-Hour Intraocular Pressure (IOP) Profile: Month 12|Response: Yes = had an IOP 24-hour profile; No = did not have an IOP 24-hour profile.|Month 12|PP; N = number of participants with analyzable data at observation.||Participants|||Number
827740|NCT01209702|Secondary|Part 2: Clearance of Tocilizumab|Clearance of tocilizumab at steady state after 12 weeks of treatment.|Week 12, pre-dose and at the end of infusion, on the 2nd and 7th day of Week 12, 14 days post-dose (Week 14) and 28 days post-dose (pre-dose of Week 16 infusion).|Due to premature study termination pharmacokinetic parameters were not analyzed.|||||
836874|NCT01301079|Primary|Pain 150 Minutes|The scale measure pain after 150 minutes (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10.|150 minutes|||units on a scale||Standard Deviation|Mean
827730|NCT01209624|Primary|Change From Baseline in Raw Intraocular Pressure (IOP) by Visit|Mean IOP values measured by applanation tonometry or noncontact method; valid range: 8-40 millimeters of mercury (mmHg). Only the IOP reading for the eye treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed. Last visit = last post-baseline visit at which participant provides a value of IOP.|Baseline, Month 6, Month 12, Month 18, Month 24, Last Visit|Per protocol (PP) analysis set: all participants in the Full Analysis Set (at least 1 dose of Xalatan® and 1 post-baseline IOP measurement) who were treated for ≥18 months; had at least BL and 1 post-BL non-missing efficacy assessments for IOP at least 18 months apart; without ametropy at BL; and without additional glaucoma medication during study.||mmHg||Standard Deviation|Mean
827731|NCT01209689|Primary|Percentage of ASsessment in Ankylosing Spondylitis 20 (ASAS20) Responders at Week 12|ASAS20 was defined as an improvement of ≥ 20% and an absolute improvement of ≥ 10 units on a 0-100 visual analog scale (VAS) from Baseline to Week 12 in 3 of 4 domains: 1-Patient global assessment (with extremes labelled none and severe), 2-Pain assessment (average total and nocturnal pain scores with extremes labelled no pain and most severe pain), 3-Function (represented by the Bath Ankylosing Spondylitis (BAS) Functional Index [BASFI] average of 10 questions regarding ability to perform specific tasks with extremes labelled easy and impossible), and 4-Inflammation (average of the last 2 questions on the 6-question BAS Disease Activity Index [BASDAI] concerning morning stiffness intensity with extremes labelled none and very severe and duration between 0 and 2 or more hours); and the absence of deterioration (of at least 20% and absolute change of at least 10 units on a 0-100 mm scale) in the remaining domain.|Baseline to Week 12|Intent-to-treat population: All randomized patients who received at least 1 dose of treatment. The analysis only included assessments while patients were receiving double-blind treatment and that occurred prior to withdrawal or the date when all patients were unblinded (15 Jul 2011). Patients who withdrew or escaped were considered non-responders.||Percentage of patients|||Number
827732|NCT01209702|Secondary|Part 1: The Number of Participants With Adverse Events|A serious adverse event (AE) is any event that is fatal, life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant or requires intervention to prevent one or other of the outcomes listed above. The intensity of each AE was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.02. A severe AE was any event of Grade 4 (life-threatening consequences; urgent intervention indicated) or 5 (death related to AE).|Up to 40 weeks|The safety analysis population included all patients who received at least one tocilizumab/placebo infusion and had at least one postdose safety assessment. Patients were assigned to treatment groups as treated for analysis.||participants|||Number
827733|NCT01209702|Secondary|Part 2: Percentage of Participants With a Reduction of Magnetic Resonance Imaging (MRI) Proven Spinal Inflammation|Magentic resonance imaging of the axial skeleton was to be performed at Baseline and Week 24. MRI scans will be evaluated using the ankylosing spondylitis spinal MRI activity (ASspiMRI-a) score, grading activity (0-6) per vertebral unit in 23 units.|Baseline and Week 24|Due to premature study termination this outcome measure was not analyzed.|||||
827734|NCT01209702|Secondary|Part 2: Radiographic Change According to the Modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS)|"Radiographs were to be assessed using the modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS). The mSASSS is a four-point scoring system for lateral radiographs of the lumbar and cervical spine and has been shown to reliably track disease progression over time, where:
0 = No abnormality;
1 = Erosion, sclerosis, or squaring;
2 = Syndesmophyte;
3 = Total bony bridging at each site."|Baseline and Week 104|This outcome measure was not analyzed due to premature study termination.|||||
827735|NCT01209702|Primary|Part 2: Percentage of Participants Achieving a 20% Improvement in Assessment in Ankylosing Spondylitis (ASAS20) at Week 12|"ASAS is composed of four domains. To achieve an ASAS20 response required improvement of ≥20% and ≥ 1 unit (10 mm) in at least 3 domains and no worsening of ≥ 20 % and ≥ 1 unit (10 mm) in the remaining domain.
The patient's global assessment of current disease status, measured on a 100 mm visual analog scale (VAS), from symptom-free / no AS symptoms (0) to maximum AS disease severity (100).
The patient's overall assessment of the severity of spinal pain based on responses to 2 questions assessed on a 100 mm VAS, from no pain (0) to most severe pain (100). The spinal pain score is the mean of these 2 questions.
The function component was measured by the Bath Ankylosing Spondylitis Functional Index (BASFI). The patient provides self-assessment of 10 questions on a 100 mm VAS. The BASFI score is the mean of these values.
The inflammation component of the ASAS was determined by the mean of questions 5 and 6 of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)."|Baseline and Week 12|Intent-to-treat (ITT) population. The analysis only includes assessments while the patient was receiving double blind medication, and occurred prior to both withdrawal and the 15 July 2011 (date at which all patients were unblinded). Patients who withdrew or escaped are considered as non-responders until week 24.||percentage of participants|||Number
827736|NCT01209702|Secondary|Number of Participants With Anti-tocilizumab Antibodies|A positive anti-tocilizumab antibody result was defined as a negative assay result at Baseline and a positive post-baseline screening assay with positive confirmation or neutralizing assay at the same visit.|From Baseline until end of study (a maximum treatment duration of 40 weeks).|All patients treated with tocilizumab and screened for anti-tocilizumab antibodies at any timepoint.||participants|||Number
827737|NCT01209702|Secondary|Change From Baseline in Level of Soluble Interleukin-6 Receptor|"Soluble Interleukin-6 receptor levels were measured from blood samples taken pre-dose at Baseline and after 12 weeks of treatment.
The analysis was not performed for participants in Part 2 due to premature study termination."|Baseline and Week 12|Pharmacokinetic Population: All patients who received at least one tocilizumab infusion and had at least one pharmacokinetic and pharmacodynamic sample. Only those patients with available data at each time point are included in the analysis (indicated by N). Patients who did not receive their week 8 dose were excluded.||ng/mL||Standard Deviation|Mean
827738|NCT01209702|Secondary|Change From Baseline in the Level of Interleukin-6|"Interleukin-6 levels were measured from blood samples taken pre-dose at Baseline and after 12 weeks of treatment.
The analysis was not performed for participants in Part 2 due to premature study termination."|Baseline and Week 12|Pharmacokinetic (PK) Population: All patients who received at least one tocilizumab infusion and had at least one PK and pharmacodynamic sample. Only patients with available data at each time point are included (indicated by N). Patients who did not receive their Week 8 dose were excluded.||pg/mL||Standard Deviation|Mean
827743|NCT01209702|Secondary|Part 2: Area Under the Plasma Concentration Versus Time Curve of Tocilizumab|Area under the plasma concentration versus time curve (AUC) of tocilizumab at steady state after 12 weeks of treatment.|Week 12, pre-dose and at the end of infusion, on the 2nd and 7th day of Week 12, 14 days post-dose (Week 14) and 28 days post-dose (pre-dose of Week 16 infusion).|Due to premature study termination pharmacokinetic parameters were not analyzed.|||||
827744|NCT01209702|Secondary|Change From Baseline in C-Reactive Protein|Levels of C-reactive protein (CRP) were measured from blood samples taken at Baseline and at Week 12.|Baseline and Week 12|Intent-to-treat population where data were available. The analysis was not performed for participants in Part 2 due to premature study termination.||mg/dL||Standard Deviation|Mean
827745|NCT01209702|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI)|"The Bath Ankylosing Spondylitis Metrology Index linear function is a combined index of 5 clinical measurements (performed by the Joint Assessor) which reflect axial mobility in the AS patient. The measurements to assess mobility are:
Tragus-to-wall;
Modified Schober (lumbar flexion);
Cervical rotation;
Lateral spinal flexion;
Intermalleolar distance.
The BASMI linear result is the average of the 5 assessments and ranges from 0 to 10. The higher the BASMI score the more severe the patient’s limitation of movement due to their AS."|Baseline and Week 12|Intent-to-treat population where data were available. The analysis was not performed for participants in Part 2 due to premature study termination.||scores on a scale||Standard Deviation|Mean
827746|NCT01209702|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)|The Bath Ankylosing Spondylitis Functional Index (BASFI) is an assessment of function in AS patients. The participant provides their assessment of their ability to perform 10 activities on a 100 mm horizontal visual analog scale (VAS) ranging from 0 (easy) to 100 (impossible). The BASFI score is the mean of these values and is tabulated on a 0 (best) to 10 (worst) cm scale.|Baseline and Week 12|Intent-to-treat population for whom data were available. The analysis was not performed for participants in Part 2.||cm||Standard Deviation|Mean
827747|NCT01209702|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)|"The BASDAI is a patient-administered assessment of 6 parameters specific to AS. The following parameters were assessed on a 100-mm horizontal visual analogue: fatigue, spinal pain, peripheral arthritis, enthesitis, intensity of morning stiffness, and duration of morning stiffness. For questions 1 to 5, the left-hand extreme of the line (0) represents none (symptom-free) and the right-hand extreme (100) represents very severe (maximum severity). For question 6, a time axis was used, with the left-hand extreme of the line representing 0 hours and the right-hand extreme representing 2 or more hours. The BASDAI score was calculated as follows:
BASDAI = [Q1 + Q2 + Q3 + Q4 + (Q5 + Q6)/2]/5. The total score is tabulated on a scale from 0 (best) to 10 cm (worst)."|Baseline and Week 12|Intent-to-treat population where data were available.||cm||Standard Deviation|Mean
827748|NCT01209702|Secondary|Part 2: Percentage of Participants Achieving a 40% Improvement in Assessment in Ankylosing Spondylitis (ASAS40) at Week 24|"ASAS is composed of four domains. To achieve an ASAS40 response required improvement of ≥40% and ≥ 2 units (20 mm) in at least 3 domains and no worsening at all in the remaining domain.
The patient's global assessment of current disease status, measured on a 100 mm visual analog scale (VAS), from symptom-free / no AS symptoms (0) to maximum AS disease severity (100).
The patient's overall assessment of the severity of spinal pain based on responses to 2 questions assessed on a 100 mm VAS, from no pain (0) to most severe pain (100). The spinal pain score is the mean of these 2 questions.
The function component was measured by the Bath Ankylosing Spondylitis Functional Index (BASFI). The patient provides self-assessment of 10 questions on a 100 mm VAS. The BASFI score is the mean of these values.
The inflammation component of the ASAS was determined by the mean of questions 5 and 6 of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)."|Baseline and Week 24|Intent-to-treat (ITT), Part 2 study population. This analysis was not performed due to premature study termination.|||||
827749|NCT01209702|Secondary|Percentage of Participants Achieving a 40% Improvement in Assessment in Ankylosing Spondylitis (ASAS40) at Week 12|"ASAS is composed of four domains. To achieve an ASAS40 response required improvement of ≥40% and ≥ 2 units (20 mm) in at least 3 domains and no worsening at all in the remaining domain.
The patient's global assessment of current disease status, measured on a 100 mm visual analog scale (VAS), from symptom-free / no AS symptoms (0) to maximum AS disease severity (100).
The patient's overall assessment of the severity of spinal pain based on responses to 2 questions assessed on a 100 mm VAS, from no pain (0) to most severe pain (100). The spinal pain score is the mean of these 2 questions.
The function component was measured by the Bath Ankylosing Spondylitis Functional Index (BASFI). The patient provides self-assessment of 10 questions on a 100 mm VAS. The BASFI score is the mean of these values.
The inflammation component of the ASAS was determined by the mean of questions 5 and 6 of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)."|Baseline and Week 12|Intent-to-treat (ITT) population. If the response at the Week 12 visit could not be determined due to early withdrawal or missing data then the patient is considered a non-responder. The analysis was not performed for participants in Part 2 due to premature study termination.||percentage of participants|||Number
827750|NCT01209702|Secondary|Percentage of Participants Who Achieved a Value <2 in Each of the 4 ASAS Parameters at Week 12|"Assessment in Ankylosing Spondylitis (ASAS) is composed of four domains.
The patient's global assessment of current disease status, measured on a 100 mm visual analog scale (VAS), from symptom-free / no AS symptoms (0) to maximum AS disease severity (100).
The patient's overall assessment of the severity of spinal pain based on responses to 2 questions assessed on a 100 mm VAS, from no pain (0) to most severe pain (100). The spinal pain score is the mean of these 2 questions.
The function component was measured by the Bath Ankylosing Spondylitis Functional Index (BASFI), the mean of 10 self-assessment questions on a 100 mm VAS.
The inflammation component of the ASAS was determined by the mean of questions 5 and 6 of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI).
Each of the above 4 domains are measured on a scale from 0-100 mm, but reported on a 0-10 cm scale. A score of less than 2 units (20 mm) in each domain is defined as partial remission."|Week 12|Intent-to-treat. If the response at the Week 12 visit could not be determined due to early withdrawal or missing data then the patient is considered a non-responder. The analysis was not performed for participants in Part 2 due to premature study termination.||percentage of participants|||Number
827938|NCT01205269|Secondary|Systolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose|Average systolic blood pressure value|0, 30 min, 2 h, 4 h|Of the 28 randomised patients, 27 completed the study and one discontinued during the last washout period. All 28 randomised patients were included in the analyses of all variables||mmHg||Standard Deviation|Mean
827751|NCT01209702|Secondary|Part 2: Percentage of Participants Achieving a 20% Improvement in Assessment in Ankylosing Spondylitis (ASAS20) at Week 24|"ASAS is composed of four domains. To achieve an ASAS20 response required improvement of ≥20% and ≥ 1 unit (10 mm) in at least 3 domains and no worsening of ≥ 20 % and ≥ 1 unit (10 mm) in the remaining domain.
The patient's global assessment of current disease status, measured on a 100 mm visual analog scale (VAS), from symptom-free / no AS symptoms (0) to maximum AS disease severity (100).
The patient's overall assessment of the severity of spinal pain based on responses to 2 questions assessed on a 100 mm VAS, from no pain (0) to most severe pain (100). The spinal pain score is the mean of these 2 questions.
The function component was measured by the Bath Ankylosing Spondylitis Functional Index (BASFI). The patient provides self-assessment of 10 questions on a 100 mm VAS. The BASFI score is the mean of these values.
The inflammation component of the ASAS was determined by the mean of questions 5 and 6 of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)."|Baseline and Week 24|Intent-to-treat (ITT) population. The analysis only includes assessments while the patient was receiving double blind medication, and occurred prior to both withdrawal and the 15 July 2011 (date at which all patients were unblinded). Patients who withdrew or escaped are considered as non-responders until week 24.||percentage of participants|||Number
827752|NCT01209702|Primary|Part 1: Percentage of Participants Achieving a 20% Improvement in Assessment in Ankylosing Spondylitis (ASAS20) at Week 12|"ASAS is composed of four domains. To achieve an ASAS20 response required improvement of ≥20% and ≥ 1 unit (10 mm) in at least 3 domains and no worsening of ≥ 20 % and ≥ 1 unit (10 mm) in the remaining domain.
The patient's global assessment of current disease status, measured on a 100 mm visual analog scale (VAS), from symptom-free / no AS symptoms (0) to maximum AS disease severity (100).
The patient’s overall assessment of the severity of spinal pain based on responses to 2 questions assessed on a 100 mm VAS, from no pain (0) to most severe pain (100). The spinal pain score is the mean of these 2 questions.
The function component was measured by the Bath Ankylosing Spondylitis Functional Index (BASFI). The patient provides self-assessment of 10 questions on a 100 mm VAS. The BASFI score is the mean of these values.
The inflammation component of the ASAS was determined by the mean of questions 5 and 6 of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)."|Baseline and Week 12|"Intent-to-treat (ITT) population included all patients who were randomized into the study and received at least one tocilizumab/placebo infusion.
If the response at the 12-week visit could not be determined due to early withdrawal or missing data then the patient was considered a non-responder."||percentage of participants|||Number
827753|NCT01209767|Primary|Blinded Rating of the Treatment Area (Cryolipolysis vs. Subcision) With the Best Cosmetic Appearance.|"Two dermatologists blindly evaluated and compared the treated and control areas of each side at the final follow up visit (week 12). They rated the area with the best cosmetic appearance and reported the percentages of participants for whom Cryolipolysis or Subcision resulted in the best cosmetic appearance. It was possible for raters to determine that neither treatment outperformed the other, thereby rating the control arm better."|12 weeks|||Percentage of participants||90% Confidence Interval|Number
827754|NCT01209780|Secondary|Number of Subjects Reporting Unsolicited Adverse Events After Vaccination With Investigational TIV and Control Vaccine|The number of 3-17 year old children reporting any unsolicited adverse event and any serious adverse event (SAE) after receiving either one or two doses of investigational TIV and control vaccine are reported.|Day 1 to 180 (non-naive )/Day 1 to 209 (naive)|Analysis was done on the safety set population.||Subjects|||Number
827755|NCT01209780|Secondary|Number of Subjects Reporting Solicited Adverse Events After Vaccination With Investigational TIV and Control Vaccine|The number of 3-17 year old children with solicited local and systemic adverse events and other adverse events, after receiving either one or two doses of investigational TIV as compared to control vaccine are reported.|Day 1 to 7 after vaccination|Analysis was done on the safety set population i.e all subjects who received at least one study vaccine and provided post vaccination safety data.||Subjects|||Number
827756|NCT01209780|Secondary|Percentages of Vaccine-naive Children Achieving Seroconversion in Antibody Titers, After Receiving Two Doses of Investigational TIV or Control Vaccine|"The percentages of 3 to 8 years-old vaccine naive children achieving seroconversion or significant increase in HI antibody titers after receiving two doses of investigational TIV or control vaccine, are reported. The time frame of evaluation was 28 days after first (Day 29) and 21 days after the second dose (Day 50).
This criterion, according to the US (CBER) guideline, is met if the lower limit of 95% CI of percentage of subjects achieving seroconversion or significant increase at day 29 and day 50 is ≥40, for each vaccine strain."|Day 29 and Day 50|Analysis was done on the per protocol population.||Percentages of subjects||95% Confidence Interval|Number
827757|NCT01209780|Secondary|Percentages of Vaccine-naive Children Achieving HI Titers ≥40 After Receiving Two Doses of Investigational TIV or Control Vaccine.|"The percentage of 3 to 8 years-old vaccine-naive subjects achieving HI titers ≥40, after receiving two doses of investigational TIV or control vaccine. The time frame of evaluation was 28 days after first (Day 29) and 21 days after second vaccine dose (Day 50).
This criterion according to the US (CBER) guideline is met if the lower bound of the two sided 95%CI for percentage of subjects achieving HI titers ≥40 is ≥70%, for each vaccine strain."|Day 1, Day 29, and Day 50|Analysis was done on the per protocol population.||Percentages of subjects||95% Confidence Interval|Number
827758|NCT01209780|Secondary|Percentages of Subjects With Seroconversion in Antibody Titers Following Vaccination With Investigational TIV or Control Vaccine|"The percentages of 3 to 8 years-old subjects achieving seroconversion in HI antibody titers after receiving either one or two doses of investigational TIV or control vaccine, at 21 days after last vaccination, are reported.
This criterion, according to the US (CBER) guideline, is met if the lower limit of 95% CI of percentage of subjects achieving seroconversion or significant increase at day 22 and day 50 (21 days after last vaccination) is ≥40."|Day 22 for non-naive/Day 50 for naive|Analysis was performed on the per protocol population.||Percentages of subjects||95% Confidence Interval|Number
827759|NCT01209780|Primary|Comparison of Antibody Responses of Investigational TIV to Control Vaccine in Terms of Post Vaccination Geometric Mean Titers (GMTs)|The non-inferiority of the antibody responses of investigational TIV compared to control vaccine assessed in terms of post vaccination GMTs, at 21 days after last vaccination against the three homologous vaccine strains in 3 to 8 year old children.|Day 22 for non-naive/Day 50 for naive subjects|Analysis was performed on the per protocol population.||Titers||95% Confidence Interval|Geometric Mean
827760|NCT01209780|Secondary|Percentages of Subjects Achieving HI Titers ≥40 Following Vaccination With Investigational TIV or Control Vaccine.|"The percentages of 3 to 8 year old subjects achieving HI titers ≥40 after receiving either one or two doses of investigational TIV or control vaccine, 21 days after last vaccination, are reported.
This criterion according to the US (CBER)guideline is met if the lower bound of the two sided 95%CI for percentage of subjects achieving HI titers ≥40, is ≥70%."|Day 22 for non-naive/Day 50 for naive subjects|Analysis was performed on per protocol population.||Percentages of subjects||95% Confidence Interval|Number
827761|NCT01209780|Primary|Comparison of Antibody Responses of Investigational TIV to Control Vaccine in Terms of the Percentage of Subjects Achieving Seroconversion|"The non-inferiority of the antibody responses of investigational TIV compared to control TIV assessed in terms of the percentage of subjects achieving seroconversion, against the three homologous vaccine strains,in children 3 to 8 years of age, at 21 days after last vaccination.
Seroconversion was defined as a pre-vaccination haemagglutinin inhibition (HI) titer <1:10 and post-vaccination HI titer ≥1:40 or as a pre-vaccination HI titer ≥1:10 and at minimum four-fold rise in post-vaccination antibody titer"|Day 22 for non-naive/Day 50 for naive subjects|Analysis was done on per protocol population i.e-all subjects who correctly received study vaccinations,provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to unblinding.||Percentages||95% Confidence Interval|Number
827762|NCT01209949|Secondary|Number of Participants With Tolerability Assessments Resulting in an Adverse Event|Number of participants with tolerability assessments resulting in an adverse event. Tolerability assessments include erythema (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe); Scaling (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe); Dryness (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe); Stinging/Burning (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) with a score of None being best and a score of Severe being worst.|12 weeks|Safety||participants|||Number
827763|NCT01209949|Secondary|Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12.|Mean percent change from baseline in lesions counts (inflammatory, non-inflammatory, and total) at week 12.|Week 12|Modified ITT (subjects with a baseline and week 12 visit)||percent change from baseline||Standard Deviation|Mean
827764|NCT01209949|Primary|Number of Participants Who Were a Success (Subject's Global Assessment of 'Clear' or 'Almost Clear') at Week 12|Number of participants who were a Success (Subject's Global Assessment of 'Clear or 'Almost Clear') at week 12. Subject's Global Assessment is measured on a scale (Clear, Almost Clear, Mild, Moderate, Severe, Very Severe) with Clear being best and Very Severe being worst.|12 weeks|Modified ITT (subjects with a baseline and week 12 visit)||participants|||Number
827765|NCT01210001|Other Pre-specified|Hypoglycaemic Events|Number of patients with hypoglycaemic events, as reported as adverse events.|From first drug administration until 7 days after last intake of study drug, up to 256 days|Treated set which included all patients treated with at least one dose of randomised study medication||percentage of participants|||Number
827766|NCT01210001|Primary|HbA1c Change From Baseline for Pio and Met Background Medication Patients|"Change From Baseline in HbA1c after 24 weeks for patients with pioglitazone (pio) and metformin (met) background medication only.
Note that adjusted means are provided."|Baseline and 24 weeks|Full analysis set (FAS) which included all randomised and treated patients who had a baseline HbA1c value for patients on pioglitazone and metformin background medication. Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.||percentage of HbA1c||Standard Error|Mean
827767|NCT01210001|Secondary|Body Weight Change From Baseline|"Change from baseline in body weight after 24 weeks.
Note that adjusted means are provided."|Baseline and 24 weeks|Full analysis set (FAS) which included all randomised and treated patients who had a baseline HbA1c value. Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.||kg||Standard Error|Mean
827768|NCT01210001|Secondary|Fasting Plasma Glucose (FPG) Change From Baseline|"Change from baseline in fasting plasma glucose (FPG) after 24 weeks of treatment.
Note that adjusted means are provided."|Baseline and 24 weeks|Full analysis set (FAS) which included all randomised and treated patients who had a baseline HbA1c value. Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.||mg/dL||Standard Error|Mean
827769|NCT01210001|Primary|HbA1c Change From Baseline|"Change From Baseline in HbA1c after 24 weeks.
Note that adjusted means are provided."|Baseline and 24 weeks|Full analysis set (FAS) which included all randomised and treated patients who had a baseline HbA1c value. Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.||percentage of HbA1c||Standard Error|Mean
827770|NCT01210079|Primary|Change in Pain Threshold Time From Baseline to Week 5|Change in pain threshold time from baseline (pre-gabapentin) to week 5 (post gabapentin)measured during cold pressor task administered at peak methadone blood levels. Pain threshold time is the amount of time that passes before pain is detected after administration of the cold pressor.|baseline, 5 weeks|||seconds||Standard Error|Mean
827771|NCT01210118|Secondary|Days of Prematurity of Birth|Days of prematurity of birth were recorded|After child birth|Only the participants who met the inclusion criteria and completed the research protocol were included in the research analysis.||number of days||Standard Deviation|Mean
827772|NCT01210118|Primary|The Effectiveness of the Interventions According the Levels of Urine Cotinine Before and After Intervention.|The basic primary outcomes of the study present the levels of urine cotinine before and after intervention separately for each group according to the cut of point that is used for the separation of active from passive smoking ,when urine cotinine ≤80ng/ml: there is biochemically validated smoking cessation.|At the baseline and at the 32nd week of gestation|||percentage of participants who quit|||Number
827773|NCT01210118|Secondary|Birth Weight|Infants' birth weight was recorded.|After child birth|Only the participants who met the inclusion criteria and completed the research protocol were included in the research analysis.||birth weight in grams||Standard Deviation|Mean
827774|NCT01210118|Primary|Participants' Smoking Status|participants' smoking status was validated by urine cotinine and urine nicotine|around the 32nd week of gestation.|Only the participants who met the inclusion criteria and completed the research protocol were included in the research analysis||ng/ml||Standard Deviation|Mean
827775|NCT01210144|Secondary|Number of Participants With a Specific Histological Pattern of the Endometrium in Participants With Good or Poor Response to Gonal-f®|Participants with each histological pattern of endometrium were analyzed. Histological patterns included: Proliferative phase (described as the endometrial on the first two weeks after the menstruation [or before ovulation]), Early secretory phase (first step of the secretory phase, located at the Day 16-18 of the cycle), Intermediate secretory phase (secretory phase located at the Day 20-22 of the cycle and describes endometrial closer to the implantation phase). Participants with poor response: 5 mature oocytes or less; participants with good response: more than 8 mature oocytes.|Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f®|Data for histological pattern of the endometrium in participants with good or poor response to Gonal-f were not summarized because the number of participants in each group with respect to ovarian response were too low.|||||
827776|NCT01210144|Secondary|Gene Expression in Participants With Good or Poor Response to Gonal-f®|A list of genes based on gene expression profiling carried out on RNA extracted from endometrial tissue. The expression of mRNA in endometrial tissue was measured by using microarrays such as the Affymetrix® GeneChip HG-U133 plus 2.0 array or equivalent. Participants with poor response: 5 mature oocytes or less; participants with good response: more than 8 mature oocytes.|Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f®|Data were not analyzed because gene expression of the endometrium could not be performed due to poor quality of biopsy samples and poor recruitment in the study.|||||
827777|NCT01210144|Secondary|Number of Participants With a Specific Histological Pattern of the Endometrium in Participants Without Blastocyst Transfer|Participants with each histological pattern of endometrium were analyzed. Histological patterns included: Proliferative phase (described as the endometrial on the first two weeks after the menstruation [or before ovulation]), Early secretory phase (first step of the secretory phase, located at the Day 16-18 of the cycle), Intermediate secretory phase (secretory phase located at the Day 20-22 of the cycle and describes endometrial closer to the implantation phase).|Day 5 or 6 (window of implantation) after Oocyte Retrieval|"ITT population: participants who received at least one dose of study medication. N (number of participants analyzed) signifies participants who were evaluable for this measure. Data were not analyzed for Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol) group because there were no participants without blastocyst transfer in this group."||participants|||Number
827778|NCT01210144|Secondary|Gene Expression in Participants Without Blastocyst Transfer|A list of genes based on gene expression profiling carried out on RNA extracted from endometrial tissue. The expression of mRNA in endometrial tissue was measured by using microarrays such as the Affymetrix® GeneChip HG-U133 plus 2.0 array or equivalent.|Day 5 or 6 (window of implantation) after Oocyte Retrieval|Data were not analyzed because gene expression of the endometrium could not be performed due to poor quality of biopsy samples and poor recruitment in the study.|||||
827779|NCT01210144|Secondary|Number of Participants With a Specific Histological Pattern of the Endometrium Following 1 Cycle With Gonal-f® and Having Undergone Agonist or Antagonist Protocol|Participants with each histological pattern of endometrium were analyzed. Histological patterns included: Proliferative phase (described as the endometrial on the first two weeks after the menstruation [or before ovulation]), Early secretory phase (first step of the secretory phase, located at the Day 16-18 of the cycle), Intermediate secretory phase (secretory phase located at the Day 20-22 of the cycle and describes endometrial closer to the implantation phase).|Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f®|"ITT population included those participants who received at least one dose of study medication. Here N (number of participants analyzed) signifies those participants who were evaluable for this measure."||participants|||Number
827780|NCT01210144|Secondary|Gene Expression of the Endometrium Following 1 Cycle With Gonal-f® in Participants Having Undergone Agonist or Antagonist Protocol|A list of genes based on gene expression profiling carried out on RNA extracted from endometrial tissue. The expression of mRNA in endometrial tissue was measured by using microarrays such as the Affymetrix® GeneChip HG-U133 plus 2.0 array or equivalent.|Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f®|Data were not analyzed because gene expression of the endometrium could not be performed due to poor quality of biopsy samples and poor recruitment in the study.|||||
827781|NCT01210144|Secondary|Gene Expression of the Endometrium in Participants With or Without Blastocyst Transfer|A list of genes based on gene expression profiling carried out on RNA extracted from endometrial tissue. The expression of mRNA in endometrial tissue was measured by using microarrays such as the Affymetrix® GeneChip HG-U133 plus 2.0 array or equivalent.|Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f®|Data were not analyzed because gene expression of the endometrium could not be performed due to poor quality of biopsy samples and poor recruitment in the study.|||||
827782|NCT01210144|Primary|Number of Participants With a Specific Histological Pattern of the Endometrium Following 1 Cycle With Gonal-f®|Participants with each histological pattern of endometrium were analyzed. Histological patterns included: Proliferative phase (described as the endometrial on the first two weeks after the menstruation [or before ovulation]), Early secretory phase (first step of the secretory phase, located at the Day 16-18 of the cycle) and Intermediate secretory phase (secretory phase located at the Day 20-22 of the cycle and describes endometrial closer to the implantation phase).|Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f®|"Intention-to-Treat (ITT) population: participants who received at least 1 dose of study drug. N (number of participants analyzed) signifies participants evaluable for this measure. Results for both agonist and antagonist protocol are presented as total since assessment of histological pattern for whole study population was the primary objective."||participants|||Number
827783|NCT01210144|Primary|Gene Expression of the Endometrium Following 1 Cycle With Gonal-f®|A list of genes based on gene expression profiling carried out on ribonucleic acid (RNA) extracted from endometrial tissue. The expression of messenger ribonucleic acid (mRNA) in endometrial tissue was measured by using microarrays such as the Affymetrix® GeneChip HG-U133 plus 2.0 array or equivalent.|Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f®|Data were not analyzed for both agonist and antagonist protocol as total, which was the primary objective, since gene expression of the endometrium could not be performed due to poor quality of biopsy samples and poor recruitment in the study.|||||
827784|NCT01210170|Secondary|Albuterol Induced Percent Change in Qaw|Qaw will be measured before and 15 min after albuterol inhalation|change in Qaw 15 minutes after albuterol inhalation|||percent change in Qaw||Standard Error|Mean
827786|NCT01210443|Secondary|Change From Baseline in Blood Concentration of N-amino Terminal Fragment of the Prohormone Brain Natriuretic Peptide (NT-pro BNP)|Change from baseline in Blood Concentration of NT-pro BNP is calculated as the value at each time point (every 12 weeks until Week 48 and every 24 weeks after Week 48) minus value at baseline.|Up to 22 days (last participant discontinuation)|"The efficacy analysis set was defined as all subjects who receive at least one dose of study drug during this extension study and have efficacy observations at baseline of the preceding study (B1321052) in any efficacy assessments.
Descriptive statistics for any efficacy endpoints were not calculated due to a small number of participants."||pg/mL||Standard Deviation|Mean
827787|NCT01210443|Secondary|Percentage of Participants With Change From Baseline in WHO Functional Class|The change from baseline in WHO functional class was classified into “Improved”, “No change” and “Worsened”. The change from baseline in WHO functional class is summarised with percentage of participants at each time point (every 12 weeks until Week 48 and every 24 weeks after Week 48).|Up to 22 days (last participant discontinuation)|"The efficacy analysis set was defined as all subjects who receive at least one dose of study drug during this extension study and have efficacy observations at baseline of the preceding study (B1321052) in any efficacy assessments.
Descriptive statistics for any efficacy endpoints were not calculated due to a small number of participants."||Parcentage of participants|||Number
827788|NCT01210443|Secondary|Change From Baseline in 6-Minute Walk Distance|Change from baseline in 6-minute walk distance is calculated as the value at each time point (every 12 weeks until Week 48 and every 24 weeks after Week 48) minus value at baseline.|Up to 22 days (last participant discontinuation)|"The efficacy analysis set was defined as all subjects who receive at least one dose of study drug during this extension study and have efficacy observations at baseline of the preceding study (B1321052) in any efficacy assessments.
Descriptive statistics for any efficacy endpoints were not calculated due to a small number of participants."||Meters||Standard Deviation|Mean
827789|NCT01210443|Secondary|Percentage of Participants With Clinical Worsening|Clinical worsening is defined as 1) Hospitalization for worsening pulmonary arterial hypertension, 2) On-study death, 3) Heart-lung or lung transplantation, 4) Atrial septostomy, 5) Addition of the chronic medications for the treatment of worsening pulmonary arterial hypertension, and 6) Initiation of oxygen.|Up to 22 days (last participant discontinuation)|"The efficacy analysis set was defined as all subjects who receive at least one dose of study drug during this extension study and have efficacy observations at baseline of the preceding study (B1321052) in any efficacy assessments.
Descriptive statistics for any efficacy endpoints were not calculated due to a small number of participants."||Percentage of participants|||Number
827790|NCT01210443|Primary|Number of Participants With Adverse Events|Number of participants with any adverse events, severe adverse events, serious adverse events|Up to 22 days (last participant discontinuation)|The safety analysis set is defined as all subjects who receive at least one dose of study drug during this extension study.||Participants|||Number
827791|NCT01210495|Secondary|Number of Participants With Treatment-related AEs in Randomized Portion|Treatment-related AE was any untoward medical occurrence in a participant with causal relationship to the study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The grade of an AE was determined according to CTCAE Version 3.0.|Up to 28 days after last dose of study drug, for up to 3 years|The safety analysis population included all randomized participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.||Participants|||Number
827792|NCT01210495|Secondary|Number of Participants With Treatment-emergent Adverse Events (AEs) in Randomized Portion|An AE was an untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes: death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, congenital anomaly. Treatment-emergent AEs were those with initial onset or that worsen in severity after the first dose of study medication. The grade of an AE was determined according to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.|Up to 28 days after last dose of study drug, for up to 3 years|The safety analysis population included all randomized participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.||Participants|||Number
827793|NCT01210495|Secondary|Number of Participants With Treatment-related AEs in Non-randomized Portion|Treatment-related AE was any untoward medical occurrence in a participant with causal relationship to the study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The grade of an AE was determined according to CTCAE Version 3.0.|Up to 28 days after last dose of study drug, for up to 3 years|The safety analysis population included participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.||Participants|||Number
827794|NCT01210495|Secondary|Number of Participants With Treatment-emergent AEs in Non-randomized Portion|An AE was an untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes: death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, congenital anomaly. Treatment-emergent AEs were those with initial onset or that worsen in severity after the first dose of study medication. The grade of an AE was determined according to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.|Up to 28 days after last dose of study drug, for up to 3 years|The safety analysis population included participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.||Participants|||Number
827795|NCT01210495|Secondary|Number of Participants With Dose-limiting Toxicities (DLTs) in Non-randomized Portion|Number of Child-Pugh Class B (score 7) participants with DLT was evaluated during Cycle 1 of treatment in the non-randomized portion of the study.|Cycle 1 (4 weeks)|Participants with Child-Pugh Class B, score 7 are only included in this analysis.||Participants|||Number
827796|NCT01210495|Secondary|EQ-VAS in Randomized Portion: Overall Between-treatment Comparison Based on the Repeated Measures Mixed Effects Model|EQ-5D Visual Analogue Scale (VAS) in rates the participant's overall health status using values from 0 (worst imaginable) to 100 (best imaginable). The below table included the model estimated average based on all the observed values/time points. The mixed effect model was used.|Cycle 1 Day 1 pre-dose and before any other clinical assessments, every 4 weeks thereafter while on study, at end of study treatment/withdrawal, and follow-up and at Day 28 after last dose date|FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received.||Units on a scale||95% Confidence Interval|Least Squares Mean
827797|NCT01210495|Secondary|EuroQoL (EQ-5D)- Health State Profile Utility Score in Randomized Portion: Overall Between-treatment Comparison Based on the Repeated Measures Mixed Effects Model|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. The below table included the model estimated average based on all the observed values/time points. The mixed effect model was used.|Cycle 1 Day 1 pre-dose and before any other clinical assessments, every 4 weeks thereafter while on study, at end of study treatment/withdrawal, and follow-up and at Day 28 after last dose date|FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received.||Units on a scale||95% Confidence Interval|Least Squares Mean
827798|NCT01210495|Secondary|Time to Deterioration (TTD) Based on the Composite Endpoint in Randomized Portion: Overall Between-treatment Comparison Based on the Repeated Measures Mixed Effects Model|A time to deterioration (TTD) analysis was performed for FHSI-8. Time to deterioration was defined as the time between date of randomization and date of the event.|From randomization to death or tumor progression or FHSI-8 mean score decrease >=3 points, whichever comes first|FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received.||Months||95% Confidence Interval|Median
827799|NCT01210495|Secondary|Functional Assessment of Cancer Therapy - Hepatobiliary Cancer Trial Outcome Index (FACT Hep-TOI) Questionnaire in Randomized Portion: Overall Between-treatment Comparison Based on the Repeated Measures Mixed Effects Model|The trial outcome index is defined to be the sum (PWB+FWB+HepCS), making it 32 items altogether. Each ranges from '0' – not at all to '4' - very much regarding how much each item was present in the last 7 days. FACT Hep –TOI total score ranges from 0 to 128, where the highest score represents a maximum achievable quality of life. The below table included the model estimated average based on all the observed values/time points. The mixed effect model was used.|Cycle 1 Day 1 pre-dose and before any other clinical assessments, every 4 weeks thereafter while on study, at end of study treatment/withdrawal, and follow-up and at Day 28 after last dose date|FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received.||Units on a scale||95% Confidence Interval|Least Squares Mean
827800|NCT01210495|Secondary|Functional Assessment of Cancer Therapy - Hepatobiliary Cancer Subscale (FACT Hep-CS18) Questionnaire in Randomized Portion: Overall Between-treatment Comparison Based on the Repeated Measures Mixed Effects Model|This subscale consists of 18 items rated on a scale from ‘0’ - not at all to ‘4’ - very much regarding how much each item was present in the last 7 days. FACT-Hep-CS18 total score ranges from 0 to 72. The higher score reflects better quality of life or fewer symptoms. The 18 items of this scale are associated with hepatocellular carcinoma. The below table included the model estimated average based on all the observed values/time points. The mixed effect model was used.|Cycle 1 Day 1 pre-dose and before any other clinical assessments, every 4 weeks thereafter while on study, at end of study treatment/withdrawal, and follow-up and at Day 28 after last dose date|FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received.||Units on a scale||95% Confidence Interval|Least Squares Mean
827801|NCT01210495|Secondary|FACT-G Subscales in Randomized Portion: Overall Between-treatment Comparison Based on the Repeated Measures Mixed Effects Model|FACT-G is core questionnaire of Functional Assessment of Chronic Illness Therapy (FACIT) measurement system to evaluate quality of life (QoL) in cancer population. FACT-G consisted of 27 questions grouped in 4 domains of general Health-Related QoL (HRQoL): Physical Well-being (PWB), Social/Family Well-Being (SWB) , Emotional Well-Being (EWB) and Functional Well-Being (FWB). Each of the individual subscale, except EWB has 7 items and each integer scored 0 to 4 making a maximum possible score of 28 (range 0 to 28). EWB has 6 items and each integer scored 0 to 4 making a maximum possible score of 24 (range 0 to 24). For all the 4 scales, higher values correspond to better health. The below table included the model estimated average based on all the observed values/time points. The mixed effect model was used.|Cycle 1 Day 1 pre-dose and before any other clinical assessments, every 4 weeks thereafter while on study, at end of study treatment/withdrawal, and follow-up and at Day 28 after last dose date|FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received.||Units on a scale||95% Confidence Interval|Least Squares Mean
827810|NCT01210495|Secondary|Axitinib Steady-state Pharmacokinetic Parameter - Time to First Occurrence of Cmax (Tmax), Non-randomized Portion|Axitinib samples were to be collected from all participants on Cycle 1 Day 15 at the following time points: pre-dose, 1, 2, 3, 4, 6 and 8 hours after axitinib dosing.|Cycle 1 Day 15|The PK concentration set included all participants who were treated and had at least 1 measured concentration on at least 1 day of PK assessment. The PK parameter analysis set included all participants treated who had at least 1 estimated PK parameter of primary interest.||Hour||Full Range|Median
827870|NCT01204658|Secondary|Concentrations of Antibodies Inhibiting Pneumococcal Pneumolysin Toxoid Haemolysis Activity – Primary Phase of the Study|Analysis of the concentrations of antibodies inhibiting pneumococcal pneumolysin toxoid haemolysis activity (anti-Ply) was not performed as no assay was validated to perform this analysis. This outcome concerns results for the Primary Phase of the study.|At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)||12/2050||||
827802|NCT01210495|Secondary|FHSI-8 in Randomized Portion: Overall Between-treatment Comparison Based on the Repeated Measures Mixed Effects Model|The FACT-Hep includes the FACT-G and a hepatobiliary module. The Hepatobiliary disease specific items include: swelling or cramps, losing weight, GI related questions, lack of energy, side effects, pain, fatigue, usual activities, jaundice, fevers, itching, taste of food and chills. Eight of the items (pain, back pain, stomach pain/discomfort, lack of energy, fatigue, nausea, weight loss, and jaundice) make up the FHSI-8, and are considered to be symptoms specific to hepatobiliary cancer. FHSI-8 total score ranges from 0 to 32 where “0” is a severely symptomatic participant and the highest score indicates an asymptomatic participant. The below table included the model estimated average based on all the observed values/time points. The mixed effect model was used.|Cycle 1 Day 1 pre-dose and before any other clinical assessments, every 4 weeks thereafter while on study, at end of study treatment/withdrawal, and follow-up and at Day 28 after last dose date|FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received.||Units on a scale||95% Confidence Interval|Least Squares Mean
827803|NCT01210495|Secondary|Functional Assessment of Cancer Therapy - General (FACT-G) in Randomized Portion: Overall Between-treatment Comparison Based on the Repeated Measures Mixed Effects Model|FACT-G is core questionnaire of Functional Assessment of Chronic Illness Therapy (FACIT) measurement system to evaluate quality of life (QoL) in cancer population. FACT-G consisted of 27 questions grouped in 4 domains of general Health-Related QoL (HRQoL): Physical Well-being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB) and Functional Well-Being (FWB);each ranging from 0 (not at all) to 4 (very much). FACT-G ranged between 0 and 108. Since questions could be reversed coded, as appropriate, before calculating FACT-G, 0 and 108 could be considered worst and best health states. The below table included the model estimated average based on all the observed values/time points. The mixed effect model was used.|Cycle 1 Day 1 pre-dose and before any other clinical assessments, every 4 weeks thereafter while on study, at end of study treatment/withdrawal, and follow-up and at Day 28 after last dose date|FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received.||Units on a scale||95% Confidence Interval|Least Squares Mean
827804|NCT01210495|Secondary|Functional Assessment of Cancer Therapy – Hepatobiliary Questionnaire (FACT-Hep) in Randomized Portion: Overall Between-treatment Comparison Based on the Repeated Measures Mixed Effects Model|FACT-Hep consists of 27-item FACT-G, and 18-item Hepatobiliary Subscale. FACT-Hep questionnaire uses 5-point Likert rating scale, range '0'-not at all to '4'. FACT-Hep total score ranges from 0 to 180, where highest score represents maximum achievable quality of life. Domains of FACT-G include Physical Well-Being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB) and Functional Well-Being (FWB). Hepatobiliary disease specific items include: swelling or cramps, losing weight, gastrointestinal-related questions, lack of energy, side effects, pain, fatigue, usual activities, jaundice, fevers, itching, taste of food and chills. Eight of the items (pain, back pain, stomach pain/discomfort, lack of energy, fatigue, nausea, weight loss and jaundice) make up FACT-Hepatobiliary Symptom Index (FHSI-8), and are considered to be symptoms specific to hepatobiliary cancer. Table below included mixed effect model estimated average based on all observed values/time points.|Cycle 1 Day 1 pre-dose and before any other clinical assessments, every 4 weeks thereafter while on study, at end of study treatment/withdrawal, and follow-up and at Day 28 after last dose date|FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received.||Units on a scale||95% Confidence Interval|Least Squares Mean
827805|NCT01210495|Secondary|Percentage of Participants With Specific miRNA Transcript Present in Circulation in Randomized Portion|A 5 mL whole blood sample was collected from all randomized participants to evaluate the miRNA transcripts.|Baseline|The miRNA analysis set included all participants in the safety analysis set who had a baseline miRNA assessment.||Percentage of participants|||Number
827806|NCT01210495|Secondary|Concentration of Soluble Proteins at Baseline in Randomized Portion|Plasma soluble proteins IL-6, E-Selectin, IL-8, HGF, MMP-2, SCF, Ang-2, VEGF-A, VEGF-C, sVEGFR2, sVEGFR3, SDF1, NGAL, MIF, c-MET, RANTES, and MCP-3 were only measured in randomized participants.|Baseline|The soluble protein analysis set included all participants in the safety analysis set who had a Baseline soluble protein assessment.||pg/mL||Standard Deviation|Mean
827807|NCT01210495|Secondary|Axitinib Steady-state Pharmacokinetic Parameter - Apparent Oral Volume of Distribution of the Drug During the Elimination Phase (Vz/F), Non-randomized Portion|Axitinib samples were to be collected from all participants on Cycle 1 Day 15 at the following time points: pre-dose, 1, 2, 3, 4, 6 and 8 hours after axitinib dosing. The PK parameter, Vz/F has been presented in this outcome measure. In the below table, 4 participants in Child-Pugh A and 1 participant in Child-Pugh B were not reported due to nonestimable half-life.|Cycle 1 Day 15|The PK concentration set included all participants who were treated and had at least 1 measured concentration on at least 1 day of PK assessment. The PK parameter analysis set included all participants treated who had at least 1 estimated PK parameter of primary interest.||Liter||95% Confidence Interval|Geometric Mean
827808|NCT01210495|Secondary|Axitinib Steady-state Pharmacokinetic Parameter - Terminal Plasma Elimination Half-life (t1/2), Non-randomized Portion|Axitinib samples were to be collected from all participants on Cycle 1 Day 15 at the following time points: pre-dose, 1, 2, 3, 4, 6 and 8 hours after axitinib dosing. In the below table, 4 participants in Child-Pugh A and 1 participant in Child-Pugh B were not reported due to nonestimable half-life.|Cycle 1 Day 15|The PK concentration set included all participants who were treated and had at least 1 measured concentration on at least 1 day of PK assessment. The PK parameter analysis set included all participants treated who had at least 1 estimated PK parameter of primary interest.||Hour||Standard Deviation|Mean
827809|NCT01210495|Secondary|Axitinib Steady-state Pharmacokinetic Parameter - Apparent Oral Clearance (CL/F), Non-randomized Portion|Axitinib samples were to be collected from all participants on Cycle 1 Day 15 at the following time points: pre-dose, 1, 2, 3, 4, 6 and 8 hours after axitinib dosing. In the below table, 4 participants in Child-Pugh A and 1 participant in Child-Pugh B were not reported due to nonestimable half-life.|Cycle 1 Day 15|The PK concentration set included all participants who were treated and had at least 1 measured concentration on at least 1 day of PK assessment. The PK parameter analysis set included all participants treated who had at least 1 estimated PK parameter of primary interest.||L/hr||95% Confidence Interval|Geometric Mean
827811|NCT01210495|Secondary|Axitinib Steady-state PK Parameter - Area Under the Plasma Concentration Versus Time Curve From 0 to 24 hr (AUC0-24), Non-randomized Portion|Axitinib samples were to be collected from all participants on Cycle 1 Day 15 at the following time points: pre-dose, 1, 2, 3, 4, 6 and 8 hours after axitinib dosing. In the below table, 4 participants in Child-Pugh A and 1 participant in Child-Pugh B were not reported due to nonestimable half-life.|Cycle 1 Day 15|The PK concentration set included all participants who were treated and had at least 1 measured concentration on at least 1 day of PK assessment. The PK parameter analysis set included all participants treated who had at least 1 estimated PK parameter of primary interest.||ng*hr/mL||95% Confidence Interval|Geometric Mean
827812|NCT01210495|Secondary|Axitinib Steady-state Pharmacokinetic (PK) Parameter - Maximum Observed Plasma Concentration (Cmax), Non-randomized Portion|Axitinib samples were to be collected from all participants on Cycle 1 Day 15 at the following time points: pre-dose, 1, 2, 3, 4, 6 and 8 hours after axitinib dosing.|Cycle 1 Day 15|The PK concentration set included all participants who were treated and had at least 1 measured concentration on at least 1 day of PK assessment. The PK parameter analysis set included all participants treated who had at least 1 estimated PK parameter of primary interest.||ng/mL||95% Confidence Interval|Geometric Mean
827813|NCT01210495|Secondary|Percentage of Participants With Overall Clinical Benefit Response (CBR) - Stratified Analysis, Randomized Portion|CBR was defined as the proportion of participants with confirmed CR or confirmed PR or a best response of stable disease ≥8 weeks according to RECIST criteria, relative to all randomized participants who had baseline measurable disease. Confirmed responses were defined as those that persisted on repeat imaging study ≥4 weeks after the initial documentation of response. Participants who did not have on study radiographic tumor re evaluation or who died, progressed, or dropped out for any reason prior to reaching a CR, PR, or stable disease were counted as non-responders in the assessment of CBR. A participant who initially met the criteria for a PR and then subsequently became a confirmed CR was to be assigned a best response of CR.|From Baseline up to end of treatment|FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received.||Percentage of participants||95% Confidence Interval|Number
827814|NCT01210495|Secondary|Duration of Response (DR) by Unstratified Analysis, Randomized Portion|DR was defined as the time from the first documentation of objective tumor response (CR or PR) that was subsequently confirmed to the first documentation of PD or to death due to any cause, whichever occurs first. If tumor progression data included more than 1 date, the first date was to be used. DR (in months) was to be calculated as (the end date for DR − first CR or PR that was subsequently confirmed +1)/30.4.|From objective response to date of progression or death|FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received. DR was calculated for the subgroup of FAS participants with objective response.||Months||95% Confidence Interval|Median
827815|NCT01210495|Secondary|Time to Tumor Progression (TTP) - Stratified Analysis, Randomized Portion|TTP was defined as the time from randomization to first documentation of objective tumor progression. If tumor progression data included more than 1 date, the first date was used. TTP (in months) was calculated as (first event date − first randomization date +1)/30.4.|Every 8 weeks until disease progression/death or start of new treatment or until at least two years after the last participant has been randomized, whatever occurs first|FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received.||Months||95% Confidence Interval|Median
827816|NCT01210495|Secondary|Objective Response Rate (ORR) - Percentage of Participants With Objective Response by Stratified Analysis, Randomized Portion.|ORR was defined as the percent of participants with confirmed complete response (CR) or confirmed partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must decrease to normal (short axis <10 mm). PR was defined as a 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Every 8 weeks until at least two years after the last participant has been randomized|FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received.||Percentage of participants||95% Confidence Interval|Number
827817|NCT01210495|Secondary|Progression-Free Survival (PFS) - Stratified Analysis, Randomized Portion|"PFS was defined as the time from randomization to first documentation of objective tumor progression or to death due to any cause, whichever occurred first. PFS (in months) was calculated as (first event date − first randomization date +1)/30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from AE data (where the outcome was Death). As per RECIST 1.1, progression was defined as ≥20% increase in the sum of the longest dimensions of the target lesions or the appearance of one or more new target lesions and unequivocal progression of existing non-target lesions, or the appearance of 1 new non-target lesions. Participants discontinuing study treatment without documented evidence of disease progression were to be followed up at least every 8 weeks after discontinuing study treatment until disease progression, or initiation of another anticancer treatment, whichever was earlier."|Every 8 weeks until disease progression/death or start of new treatment or until at least two years after the last participant has been randomized, whatever occurs first|FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received.||Months||95% Confidence Interval|Median
827818|NCT01210495|Primary|Overall Survival (OS) - Stratified Analysis, Randomized Portion|OS was defined as the time from the date of randomization to the date of death due to any cause. OS (in months) was calculated as (date of death − first randomization date +1)/30.4. For participants still alive at the time of the analysis, the OS time was censored on the last date they were known to be alive. All participants were followed up for survival at least every 3 months after discontinuing study treatment until at least two years after randomization of the last participant.|From randomization until at least two years after the last participant has been randomized|The full analysis set (FAS) included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received.||Months||95% Confidence Interval|Median
827819|NCT01210651|Secondary|Total Change Scores on Rosenberg Self-Esteem Scale (RSES) Among Study Completers|The Rosenberg Self-Esteem Scale (RSES) is a 10-item, self-administered, validated psychometric instrument to measure self-esteem, defined as having an overall feeling of self-worth and self-acceptance. Each item is scored from 0 to 3, and individual item scores are summed to yield a total possible RSES ranging from 0-30. RSES scores from 0-14 suggest low self-esteem, from 15-25 normal self-esteem, and from 26-30 high self-esteem. RSES scores of study completers were examined, and the total change score on RSES was calculated for each intervention group as the mean RSES score at 0 wks subtracted from the mean RSES score at 8 wks.|0 wks, 8 wks|Population of study completers was comprised of participants in both intervention groups who provided study measures at intervention start at 0 wks and at intervention finish at 8 wks.||points on a scale||Standard Deviation|Mean
827820|NCT01210651|Secondary|Total Change Scores on General Self-Efficacy Scale (GSES) Among Study Completers|The General Self-Efficacy Scale (GSES) is a 10-item, self-administered, validated psychometric instrument to measure self-efficacy, defined as the belief that one’s actions are responsible for successful outcomes in coping with difficult life demands. Each item is scored from 1 to 4, with a total GSES score derived by summing the individual item scores. Possible GSES scores range from 10 (no belief in one's self-efficacy) to 40 (strongest belief in one’s self-efficacy). GSES scores of study completers were examined, and the total change score on GSES was calculated for each intervention group as the mean GSES score at 0 wks subtracted from the mean GSES score at 8 wks.|0 wks, 8 wks|Population of study completers was comprised of participants in both intervention groups who provided study measures at intervention start at 0 wks and at intervention finish at 8 wks.||points on a scale||Standard Deviation|Mean
827821|NCT01210651|Primary|Number of Study Completers With Remitted Depression, Per Completers Analysis of BDI Scores at 8 Weeks|The Beck Depression Inventory-II (BDI) is a 21-item validated instrument for the self-report of depressive symptoms, with individual item scores summed to yield a total possible BDI score that ranges from 0-63. BDI scores from 0-13 suggest absent to minimal depressive symptoms, from 14-19 mild symptoms, from 20-28 moderate symptoms, and from 29-63 severe symptoms. Analysis examined BDI scores of study completers and identified in each intervention group the number of participants with an 8-wk BDI score ≤ 9, defined as remitted depression.|8 Weeks|Population of study completers with remitted depression was comprised of participants in both intervention groups who provided study measures at 0 wks and 8 wks, and achieved an 8-wk BDI score ≤ 9.||participants|||Number
827822|NCT01210651|Primary|Total Change Scores on Beck Depression Inventory-II Among Study Completers|The Beck Depression Inventory-II (BDI) is a 21-item validated instrument for the self-report of depressive symptoms, with individual item scores summed to yield a total possible BDI score that ranges from 0-63. BDI scores from 0-13 suggest absent to minimal depressive symptoms, from 14-19 mild symptoms, from 20-28 moderate symptoms, and from 29-63 severe symptoms. BDI scores of study completers were examined, and the total change score on BDI was calculated for each intervention group as the mean BDI score at 0 wks subtracted from the mean BDI score at 8 wks.|0 wks and 8 wks|Population of study completers was comprised of participants in both intervention groups who provided study measures at intervention start at 0 wks and at intervention end at 8 wks.||points on a scale||Standard Deviation|Mean
827823|NCT01210651|Primary|Intent-to-Treat Analysis of Adjusted Mean Beck Depression Inventory-II Scores Over Intervention Period|The Beck Depression Inventory-II (BDI) is a 21-item validated instrument for the self-report of depressive symptoms, with individual item scores summed to yield a total possible BDI score that ranges from 0-63. BDI scores from 0-13 suggest absent to minimal depressive symptoms, from 14-19 mild symptoms, from 20-28 moderate symptoms, and from 29-63 severe symptoms. Regression analysis software examined the BDI scores measured in study participants every 2 wks from intervention start at 0 wks until intervention end at 8 wks, using maximum likelihood estimations to derive an adjusted mean BDI score for each intervention group at each measurement point.|0 wks, 2 wks, 4 wks, 6 wks, 8 wks|Intent-to-Treat population was comprised of all randomized participants in both intervention groups, regardless of adherence to protocol or premature dropout. BDI scores of any participants missing at 0 wks were imputed by carrying forward their BDI scores from screening.||points on a scale||95% Confidence Interval|Least Squares Mean
827824|NCT01210690|Secondary|Number of Patients Who Withdraw Due to Lack or Loss of Efficacy During the Treatment Period|Number of patients who withdraw due to lack or loss of efficacy during the Treatment Period (maximum 12 months).|From Baseline through the last Treatment Visit (maximum 12 months)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS consisted of all patients in the Enrolled Set who had at least 1 post-Baseline efficacy assessment.||participants|||Number
827825|NCT01210690|Secondary|Global Evaluation Scale of Epilepsy Severity (GES)|"Global evaluation scale of epilepsy severity (GES): physician's assessment of the change from Baseline of the epilepsy severity at the last Treatment Visit (maximum 12 months). The GES is a 7-point scale that assesses change in the severity of the patient's illness. The GES is a 7-point scale with the following options:
7=Marked improvement
6=Moderate improvement
5=Slight improvement
4=No Change
3=Slight worsening
2=Moderate worsening
1=Marked worsening
As a variant of this variable, a 3-class variable was derived as follows
“Marked improvement,” “Moderate improvement,” and “Slight improvement” were defined as “Improved.”
“No change” was defined as “Stable.”
“Slight worsening,” “Moderate worsening,” and “Marked worsening” were defined as “Worsened.”"|From Baseline to the last Treatment Visit (maximum time frame is 12 months)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS consisted of all patients in the Enrolled Set who had at least 1 post-Baseline efficacy assessment. Presented is the number of subjects with a non-missing measurement at Visit 7.||participants|||Number
827836|NCT01210716|Secondary|Safety Measured by Adverse Events During the TPE Procedure||Adverse events were collected during each TPE procedure.|Adverse events were summarized for enrolled subjects per protocol. 7 out of 37 enrolled subjects experienced adverse events during the study with a total of 12 adverse events reported.||participants|||Number
827837|NCT01210716|Primary|Percent Efficiency of Plasma Removal During the Therapeutic Plasma Exchange Procedure|"The calculation is based on the volume of plasma that was processed through the machine compared to the volume of patient plasma that was actually removed during the procedure.
Plasma Efficiency = (plasma removed/plasma processed)*100"|After completion of the TPE procedure.|A total of 37 patients who consented and enrolled started the 1st procedure. Of these 37 patients, 33 patients completed the 1st procedure and started a 2nd procedure. Three patients did not complete the second procedure resulting in 30 patients with completed paired Test and Control procedures.||percentage of plasma removal efficiency||Full Range|Mean
827826|NCT01210690|Secondary|Global Evaluation Scale of the Psychomotor Development (GES)|"Global evaluation scale of the psychomotor development (GES): physician's assessment of the change from Baseline in the psychomotor development at the last Treatment Visit (maximum timeframe is 12 months). The GES is a 7-point scale with the following options:
7=Marked improvement
6=Moderate improvement
5=Slight improvement
4=No Change
3=Slight worsening
2=Moderate worsening
1=Marked worsening
As a variant of this variable, a 3-class variable was derived as follows
“Marked improvement,” “Moderate improvement,” and “Slight improvement” were defined as “Improved.”
“No change” was defined as “Stable.”
“Slight worsening,” “Moderate worsening,” and “Marked worsening” were defined as “Worsened.”"|From Baseline to the last Treatment Visit (maximum 12 months)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS consisted of all patients in the Enrolled Set who had at least 1 post-Baseline efficacy assessment. Presented is the number of subjects with a non-missing measurement at Visit 7.||participants|||Number
827827|NCT01210690|Secondary|Number of Patients With Abnormalities Noted During Neurological Examination From Baseline to the Last Treatment Visit|The Number of Patients With Abnormalities Noted During Neurological Examination cannot be given because abnormality frequencies were only determined for single parameters of the neurological examination and therefore a subject might have been counted several times.|From Baseline to the last Treatment Visit (maximum 12 months)||||||
827828|NCT01210690|Secondary|Number of Patients With Abnormalities Noted During Physical Examination From Baseline to the Last Treatment Visit|"Number of patients with abnormalities noted during physical examination over the Treatment Period (maximum 12 months). Any abnormal findings during the physical examination during the study were reported as Adverse Events (AEs).
The Number of Patients With Abnormalities Noted During Physical Examination From Baseline to the Last Treatment Visit cannot be given because abnormalities at Screening are listed only and worsening after Screening were handled as AEs and tabulated along with the other AEs."|From Baseline to the last Treatment Visit (maximum 12 months)||||||
827829|NCT01210690|Secondary|Mean Change From Baseline in Standardized Head Circumference Scores at the Safety Follow-up Visit|For each visit, head circumference was measured and age standardization was performed based on WHO growth charts to obtain z-scores. For this outcome measure, the difference of head circumference z-scores from Safety Follow-up Visit to Baseline was determined and averaged across the study population.|From Baseline to the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-week safety follow-up)|The Analysis Population refers to the Safety Set (SS). The SS consisted of all patients in the Enrolled Set who received at least 1 (partial) dose of study medication.||z-scores||Standard Deviation|Mean
827830|NCT01210690|Secondary|Mean Change From Baseline in Standardized Body Length Scores at the Safety Follow-up Visit|For each visit, body length was measured and age standardization was performed based on WHO growth charts to obtain z-scores. For this outcome measure, the difference of body length z-scores from Safety Follow-up Visit to Baseline was determined and averaged across the study population.|From Baseline to the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-week safety follow-up)|The Analysis Population refers to the Safety Set (SS). The SS consisted of all patients in the Enrolled Set who received at least 1 (partial) dose of study medication.||z-scores||Standard Deviation|Mean
827831|NCT01210690|Secondary|Mean Change From Baseline in Standardized Body Weight Scores at the Safety Follow-up Visit|For each visit, body weight was measured and standardization for gender and age was performed based on WHO growth charts to obtain z-scores. For this outcome measure, the mean of the differences of individual body weight z-scores from Safety Follow-up Visit to Baseline was determined.|From Baseline to the safety follow-up visit (maximum treatment period is 12 months plus 2-week safety follow-up)|The Analysis Population refers to the Safety Set (SS). The SS consisted of all patients in the Enrolled Set who received at least 1 (partial) dose of study medication.||z-scores||Standard Deviation|Mean
827832|NCT01210690|Secondary|Presence of Deviation From the Normal Milestones of Psychomotor Development From Baseline to the Last Treatment Visit|Number of patients with presence of deviation from the normal milestones of psychomotor development during the Treatment Period (maximum 12 months). The treating physician evaluated at each visit, as part of standard clinical practice, the psychomotor development of the patient. The evaluation of the patient’s psychomotor development was categorized by the motor development, the social development and the language development.|From Baseline to the last Treatment Visit (maximum 12 months)|The Analysis Population refers to the Safety Set (SS). The SS consisted of all patients in the Enrolled Set who received at least 1 (partial) dose of study medication. Presented is the number of subjects with non-missing data on psychomotor development at the corresponding visit.||participants|||Number
827833|NCT01210690|Secondary|Incidence of Treatment-Emergent Adverse Events (TEAEs) Leading to Temporary or Permanent Discontinuation of Keppra® (Levetiracetam) From Baseline Through the Last Visit|Number of patients with any Treatment-Emergent Adverse Events (TEAEs) leading to temporary or permanent discontinuation of Keppra® (Levetiracetam) during the Treatment Period (maximum 12 months).|From Baseline through the last Treatment Visit (maximum 12 months)|The Analysis Population refers to the Safety Set (SS). The SS consisted of all patients in the Enrolled Set who received at least 1 (partial) dose of study medication.||participants|||Number
827834|NCT01210690|Secondary|Incidence of Overall Serious Treatment-Emergent Adverse Events (TEAEs) From Baseline Through the Safety Follow-up|Number of patients with any serious Treatment-Emergent Adverse Events (TEAEs) during the study (maximum Treatment Period is 12 months plus 2-week safety follow-up).|From Baseline through the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-weeks safety follow-up)|The Analysis Population refers to the Safety Set (SS). The SS consisted of all patients in the Enrolled Set who received at least 1 (partial) dose of study medication.||participants|||Number
827835|NCT01210690|Primary|Treatment-Emergent Adverse Events (TEAEs) From Baseline Through Safety Follow-up Visit|Number of patients with any Treatment-Emergent Adverse Events (TEAEs) as reported by the patient's parent and/or caregiver or observed by the treating physician during the study (maximum Treatment Period is 12 months plus 2-week safety follow-up).|From Baseline through the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-week safety follow-up)|The Analysis Population refers to the Safety Set (SS). The SS consisted of all patients in the Enrolled Set who received at least 1 (partial) dose of study medication.||participants|||Number
829105|NCT01216397|Secondary|Linagliptin: Percentage of AUCtz-∞ Obtained by Extrapolation|Geometric Mean of percentage of AUCtz-∞ of linagliptin, where percentage is the unit of measurement.|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set||percentage||Geometric Coefficient of Variation|Geometric Mean
827838|NCT01210807|Primary|Mean LogMAR Binocular Photopic Distance Corrected Near Visual Acuity at 33 cm|Snellen equivalent for the mean logMAR binocular photopic distance corrected near visual acuity at 33 cm is 20/24 for the Multifocal Group. Snellen equivalent for the mean logMAR binocular photopic distance corrected near visual acuity at 33 cm is 20/81 for the Monofocal Group.|4-6 Months|Within the 4-6 month time frame, one assessment was performed per participant. Though 70 subjects started the study (36 ZMB00; 34 ZCB00), data for logMAR binocular photopic distance corrected near visual acuity at 33 were available for only 33 ZMB00 and 31 ZCB00 subjects at the the 4-6 month visit.||logMAR visual acuity||Standard Deviation|Mean
827839|NCT01210807|Secondary|Number of Subjects With 20/40 or Better Best Corrected Binocular Distance Visual Acuity||4-6 months|Within the 4-6 month time frame, one assessment was performed per participant. Though 70 subjects started the study (36 ZMB00; 34 ZCB00), best corrected binocular diatance visual acuity data were available for only 32 ZMB00 and 31 ZCB00 subjects at the the 4-6 month visit.||participants|||Number
827840|NCT01210820|Primary|Change in Keratometric Cylinder|Change in mean keratometric cylinder (as measured by keratometry) compared to baseline.|6 Months|||Diopters of astigmatism change||Standard Deviation|Mean
827841|NCT01210820|Primary|Change in Refractive Astigmatism|Change in mean cylinder (assessed by manifest refraction) compared to baseline.|6 months|||Diopter of cylinder change||Standard Deviation|Mean
827842|NCT01211106|Primary|Drinking Outcome|Percent days of heavy drinking during the sixteen weeks. The percentage of days in which heavy drinking occurred ranges from 0 - 100% with lower days associated with better outcomes.|16 weeks|The number of subjects available for this measure are greater than the PTSD outcome as drinking outcomes can be obtained at anytime and thus some participants provided data at the post study evaluation.||percent days ofheavy drinking||Standard Deviation|Mean
827843|NCT01211106|Primary|PTSD Symptoms|PTSD checklist (PCL), the PCL version used with the civilian PCL. The PCL is a standardized self-report rating scale for PTSD comprising 17 items that correspond to the key symptoms of PTSD. Respondents indicate how much they have been bothered by a symptom over the past month using a 5-point (1–5) scale, circling their responses. Responses range from 1 Not at All – 5 Extremely thus the total score ranges from 17 - 85. Lower scores are associated with less severity/symptoms.|16 weeks|||units on a scale||Standard Deviation|Mean
827844|NCT01204294|Secondary|Glycosylated Haemoglobin A1c (HbA1c)|The change from baseline in HbA1c after 52 weeks of treatment. When the HbA1c after 52 weeks treatment was missing, the value from the measurements at the closest preceding visit replaced the missing value.|Baseline and 52 weeks|The full analysis set (FAS) comprised all treated patients who had baseline HbA1c measurement and at least one on-treatment HbA1c measurement available||Percentage||Standard Deviation|Mean
827845|NCT01204294|Primary|Incidence of Adverse Events (AEs)|The number of patient with any AEs, patients with severe AE, patients with AEs leading to discontinuation of trial drug, and patients with Hypoglycaemic events|The first drug administration through 7 days after the last drug administration, up to 382 days|The treated set (TS) comprised all patients who received at least one dose of randomised study medication in the 52-week treatment period||Patients|||Number
827846|NCT01204398|Secondary|Change From Baseline to End of Study in In-clinic Pulse Rate||8 weeks|TS with non-missing data||beats per minute (bpm)||Standard Deviation|Mean
827847|NCT01204398|Secondary|Treatment Emergent Adverse Events|Electrocardiogram, laboratory parameters and physical examinations were performed and any abnormal findings were recorded within the adverse events|8 weeks|Treated Set (TS) defined as all patients who entered the run-in phase and were treated with T80/A5.||Participants|||Number
827848|NCT01204398|Secondary|ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing|DBP and SBP hourly means over the 24-hour dosing interval as measured by ABPM at baseline and after 8 weeks of treatment|0 and 8 weeks|FAS||mmHg||Standard Deviation|Mean
827849|NCT01204398|Secondary|Change From Baseline to End of Study in DBP and SBP|Manually measured in-clinic DBP and SBP|8 weeks|FAS||mmHg||Standard Deviation|Mean
827850|NCT01204398|Secondary|Trough to Peak (T/P) Ratio for DBP and SBP After 8 Weeks of Treatment|Calculated on the basis of changes in hourly means from baseline. Trough is defined as the mean of the last three hours of the 24-hour dosing interval. Peak is the greatest reduction in hourly means in hours 2 to 8 after dosing. All measurements are using ABPM.|8 weeks|FAS||Ratio||Full Range|Median
827851|NCT01204398|Secondary|Change From Baseline in ABPM Hourly Mean DBP and SBP, Starting 1 Hour After Dosing|Changes from baseline in DBP and SBP hourly means over the 24-hour dosing interval as measured by ABPM after 8 weeks of treatment with T80/A5|8 weeks|FAS||mmHg||Standard Deviation|Mean
827852|NCT01204398|Primary|DBP and SBP Change From Baseline in Mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Mean|ABPM measurements were taken every 20 minutes throughout the day and night by the validated SpaceLabs Model 90217 monitor.|8 weeks|Full analysis set (FAS) defined as all patients with at least one dose of T80/A5, and for whom baseline and post-baseline ABPM are available.||mmHg||Standard Deviation|Mean
827853|NCT01204658|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|An SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization, as per the medical or scientific judgement of the physician. Any = Occurrence of an SAE, regardless of relationship to vaccination.|During the entire study period (Months 0-11)|The analysis was performed on the Total Vaccinated cohort for the Primary Phase, which included all vaccinated subjects with at least one of the 3 vaccine doses against pneumococcal diseases.||Subjects|||Number
827861|NCT01204658|Secondary|Concentrations of Antibodies Against Polyribosyl Ribitol Phosphate (Anti-PRP) – Booster Phase of the Study|Antibody concentrations will be expressed as geometric mean concentrations (GMCs) in microgram per milliliter (µg/mL). The seroprotection cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.15 µg/mL or 1 µg/mL. This outcome concerns results for the Booster Phase of the study.|At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).||µg/mL||95% Confidence Interval|Geometric Mean
827854|NCT01204658|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs) – Booster Phase of the Study|An unsolicited AE was defined as any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination.|Within the 31-day (Days 0-30) period post booster vaccination|The analysis was performed on the Total Vaccinated cohort of Booster Phase, which included all subjects who received the booster dose of vaccine against pneumococcal diseases.||Subjects|||Number
827855|NCT01204658|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs) – Primary Phase of the Study|An unsolicited AE was defined as any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination.|Within the 31-day (Days 0-30) period post primary vaccination, across doses|The analysis was performed on the Total Vaccinated cohort for the Primary Phase, which included all vaccinated subjects with at least one of the 3 vaccine doses against pneumococcal diseases.||Subjects|||Number
827856|NCT01204658|Secondary|Number of Subjects With Any, Grade 3 Solicited General Symptoms and Solicited General Symptoms With Relationship to Vaccination – Booster Phase of the Study|Assessed solicited general symptoms were Drowsiness, Irritability, Loss of appetite (Loss Appet.) and Fever (rectal temperature higher than [≥] 38 degrees Celsius [°C]). Any = Occurrence of the specified solicited general symptom, regardless of intensity and relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigator as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irritability = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = Axillary temperature higher than (>) 40.0°C.|Within the 7-day (Days 0-6) period post vaccination after booster vaccination|The analysis was performed on the Total Vaccinated cohort for the Booster Phase, which included all subjects who received the booster dose of vaccine against pneumococcal diseases, with analysis done solely on subjects with post-vaccination solicited symptoms results available.||Subjects|||Number
827857|NCT01204658|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms – Booster Phase of the Study|Assessed local symptoms were pain, redness and swelling at injection site. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm).|Within the 7-day (Days 0-6) period after booster vaccination|The analysis was performed on the Total Vaccinated cohort for the Booster Phase, which included all subjects who received the booster dose of vaccine against pneumococcal diseases, with analysis done solely on subjects with post-vaccination solicited symptoms results available.||Subjects|||Number
827858|NCT01204658|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms – Primary Phase of the Study|Assessed local symptoms were pain, redness and swelling at injection site. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm).|Within the 7-day (Days 0-6) periods post vaccination, after each dose (D) of the 3-dose primary vaccination course|The analysis was performed on the Total Vaccinated cohort for the Primary Phase, which included all subjects who received at least one of the 3 vaccine doses against pneumococcal diseases, with analysis done solely on subjects with post-vaccination solicited symptoms results available.||Subjects|||Number
827859|NCT01204658|Secondary|Titers of Antibodies Against Poliovirus Types 1, 2 and 3 (Anti-1, Anti-2 and Anti-3) – Booster Phase of the Study|Antibody titers will be measured by virus microneutralization test, expressed as geometric mean titers (GMTs). The cut-off of the assay for anti-1, anti-2 and anti-3 antibody was a titer higher than or equal to (≥) 8. This outcome concerns results for the Booster Phase of the study.|At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).||Titers||95% Confidence Interval|Geometric Mean
827860|NCT01204658|Secondary|Titers of Antibodies Against Poliovirus Types 1, 2 and 3 (Anti-1, Anti-2 and Anti-3) – Primary Phase of the Study|Antibody titers will be measured by virus microneutralization test, expressed as geometric mean titers (GMTs). The cut-off of the assay for anti-1, anti-2 and anti-3 antibody was a titer higher than or equal to (≥) 8. This outcome concerns results for the Primary Phase of the study.|At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).||Titers||95% Confidence Interval|Geometric Mean
827869|NCT01204658|Secondary|Concentrations of Antibodies Inhibiting Pneumococcal Pneumolysin Toxoid Haemolysis Activity – Booster Phase of the Study|Analysis of the concentrations of antibodies inhibiting pneumococcal pneumolysin toxoid haemolysis activity (anti-Ply) was not performed as no assay was validated to perform this analysis. This outcome concerns results for the Booster Phase of the study.|At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)||12/2050||||
829106|NCT01216397|Secondary|Linagliptin: AUC0-infinity|Geometric mean of AUC0-infinity of Linagliptin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set||nmol*hr/L||Geometric Coefficient of Variation|Geometric Mean
827862|NCT01204658|Secondary|Concentrations of Antibodies Against Polyribosyl Ribitol Phosphate (Anti-PRP) – Primary Phase of the Study|Antibody concentrations will be expressed as geometric mean concentrations (GMCs) in microgram per milliliter (µg/mL). The seroprotection cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.15 µg/mL or 1 µg/mL. This outcome concerns results for the Primary Phase of the study.|At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).||µg/mL||95% Confidence Interval|Geometric Mean
827863|NCT01204658|Secondary|Concentrations of Antibodies Against Hepatitis B (Anti-HBs) – Booster Phase of the Study|"Antibody concentrations will be expressed as geometric mean concentrations (GMCs) in milli-International Units per milliliter (mIU/mL). The seroprotection cut-off of the assay was an antibody concentration higher than or equal to (≥) 10 mIU/mL. This outcome concerns results for the Booster Phase of the study.
* A decrease in the specificity of the anti-HB Enzyme-Linked ImmunoSorbent Assay (ELISA) assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete reanalysis. The retest has been performed in using Food and Drug Administration (FDA)-approved ChemiLuminescence ImmunoAssay (CLIA) commercial assay Centaur™."|At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).||mIU/mL||95% Confidence Interval|Geometric Mean
827864|NCT01204658|Secondary|Concentrations of Antibodies Against Hepatitis B (Anti-HBs) – Primary Phase of the Study|Antibody concentrations will be expressed as geometric mean concentrations (GMCs) in milli-International Units per milliliter (mIU/mL). The seroprotection cut-off of the assay was an antibody concentration higher than or equal to (≥) 10 mIU/mL. This outcome concerns results for the Primary Phase of the study. Note that the percentage of subjects with concentration ≥10 mIU/mL was over-estimated due to the use of in-house assay overestimating concentrations between 10-100 mIU/mL. Accordingly GMCs were also overestimated.|At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).||mIU/mL||95% Confidence Interval|Geometric Mean
827865|NCT01204658|Secondary|Concentrations of Antibodies Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA), Pertactin (Anti-PRN) – Booster Phase of the Study|Antibody concentrations will be measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs) in Elisa Units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration higher than or equal to (≥) 5 EL.U/mL. This outcome concerns results for the Booster Phase of the study.|At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).||EL.U/mL||95% Confidence Interval|Geometric Mean
827866|NCT01204658|Secondary|Concentrations of Antibodies Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA), Pertactin (Anti-PRN) – Primary Phase of the Study|Antibody concentrations will be measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs) in Elisa Units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration higher than or equal to (≥) 5 EL.U/mL. This outcome concerns results for the primary Phase of the study.|At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).||EL.U/mL||95% Confidence Interval|Geometric Mean
827867|NCT01204658|Secondary|Concentrations of Antibodies Against Diphtheria (Anti-D) and Tetanus (Anti-T) – Booster Phase of the Study|Antibody concentrations will be expressed as geometric mean concentrations (GMCs) in International Units per milliliter (IU/mL). The seroprotection cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.1 IU/mL. This outcome concerns results for the Booster Phase of the study.|At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).||IU/mL||95% Confidence Interval|Geometric Mean
827868|NCT01204658|Secondary|Concentrations of Antibodies Against Diphtheria (Anti-D) and Tetanus (Anti-T) – Primary Phase of the Study|Antibody concentrations will be expressed as geometric mean concentrations (GMCs) in International Units per milliliter (IU/mL). The seroprotection cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.1 IU/mL. This outcome concerns results for the Primary Phase of the study.|At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).||IU/mL||95% Confidence Interval|Geometric Mean
828226|NCT01215279|Secondary|SGRQ Total Score at End of Treatment|Decrease in score represents improved Quality of Life; increase represents deteriorated Quality of Life. An increase or decrease of 4 or more percent units is judged as the Minimal Clinically Important Difference.|week 4|||Percent of maximum possible score||Standard Deviation|Mean
827871|NCT01204658|Secondary|Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes – Booster Phase of the Study|Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (OPA-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). The Seropositivity cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns results for the Booster Phase of the study. Results for humoral immune response to the opsonophagocytic activity testing for OPA-19A will be updated when validated results become available.|At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).||Titers||95% Confidence Interval|Geometric Mean
827872|NCT01204658|Secondary|Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes – Primary Phase of the Study|Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (OPA-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). The Seropositivity cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns results for the Primary Phase of the study. Results for humoral immune response to the opsonophagocytic activity testing for OPA-19A will be updated when validated results become available.|At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).||Titers||95% Confidence Interval|Geometric Mean
827873|NCT01204658|Secondary|Antibody Concentrations Against Pneumococcal Serotypes – Booster Phase of the Study|Antibodies assessed for this outcome measure were those against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns results for the Booster Phase of the study.|At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).||µg/mL||95% Confidence Interval|Geometric Mean
827874|NCT01204658|Secondary|Antibody Concentrations Against Pneumococcal Serotypes – Primary Phase of the Study|Antibodies assessed for this outcome measure were those against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 µg/mL. This outcome concerns results for the Primary Phase of the study.|At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).||µg/mL||95% Confidence Interval|Geometric Mean
827875|NCT01204658|Secondary|Antibody Concentrations Against Protein D (Anti-PD) – Booster Phase of the Study|Antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was a concentration of anti-PD antibodies ≥ 100 EL.U/mL. This outcome concerns results for the Booster Phase of the study.|At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).||EL.U/mL||95% Confidence Interval|Geometric Mean
827876|NCT01204658|Secondary|Antibody Concentrations Against Protein D (Anti-PD) – Primary Phase of the Study|Antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was a concentration of anti-PD antibodies ≥ 100 EL.U/mL. This outcome concerns results for the Primary Phase of the study.|At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).||EL.U/mL||95% Confidence Interval|Geometric Mean
827884|NCT01204671|Secondary|Number of Subjects With Any and Related Adverse Events With Medically-attended Events (MAEs)|Medically-attended events (MAEs) refer to non-serious and serious events leading to an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits. If a MAE was leading to hospitalisation (or met any other serious adverse event criterion), it was reported as serious adverse event. Related MAE = MAE assessed by the investigator as related to the vaccination. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.|From the beginning of the study (Day 0) to study end (Day 180)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subject|||Number
827877|NCT01204658|Secondary|Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (dPly) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins – Booster Phase of the Study|Antibody concentrations against dPly and PhtD (anti-dPly and anti-PhtD, respectively) were measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). Cut-offs for seropositivity were concentrations higher than or equal to (≥)12 EL.U/mL for anti-dPly antibodies and ≥ 17 EL.U/mL for anti-PhtD antibodies. This outcome concerns results for the Booster Phase of the study.|At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).||EL.U/mL||95% Confidence Interval|Geometric Mean
827878|NCT01204658|Secondary|Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (dPly) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins – Primary Phase of the Study|Antibody concentrations against dPly and PhtD (anti-dPly and anti-PhtD, respectively) were measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). Cut-offs for seropositivity were concentrations higher than or equal to (≥)12 EL.U/mL for anti-dPly antibodies and ≥ 17 EL.U/mL for anti-PhtD antibodies. This outcome concerns results for the Primary Phase of the study.|At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).||EL.U/mL||95% Confidence Interval|Geometric Mean
827879|NCT01204658|Primary|Percentage of Subjects Reporting Fever > 40° C With Causal Relationship to Vaccination After Each Primary Vaccination Dose and Across Doses in the 10PP-HD/Infanrix Hexa Group and in the Synflorix/Infanrix Hexa Group|Grade 3 fever was defined as fever by rectal measurement >40.0°C. Related was defined as causal relationship to vaccination. This endpoint was assessed after each primary vaccination dose and across doses and in subjects in the 10PP-HD/Infanrix hexa (or 10PP-HD) and Synflorix/Infanrix hexa (or 10PN) groups only.|During the 7-day (Days 0-6) post-vaccination period following each primary vaccination dose and across doses|The analysis was performed on the Total Vaccinated cohort for the Primary Phase, which included all subjects who received at least one of the 3 vaccine doses against pneumococcal diseases, with analysis done solely on subjects with post-vaccination solicited symptoms results available.||Percentage of participants|||Number
827880|NCT01204658|Primary|Percentage of Subjects Reporting Fever > 40.0°C With Causal Relationship to Vaccination After Each Primary Vaccination Dose and Across Doses in 10PP-LD/Infanrix Hexa Group and in Synflorix/Infanrix Hexa Group|Grade 3 fever was defined as fever by rectal measurement > 40.0°C. Related was defined as causal relationship to vaccination. This endpoint was assessed after each primary vaccination dose and across doses and in subjects in the 10PP-LD/Infanrix hexa (or 10PP-LD) and Synflorix/Infanrix hexa (or 10PN) groups only.|During the 7-day (Days 0-6) post-vaccination period following each primary vaccination dose and across doses|The analysis was performed on the Total Vaccinated cohort for the Primary Phase, which included all subjects who received at least one of the 3 vaccine doses against pneumococcal diseases, with analysis done solely on subjects with post-vaccination solicited symptoms results available.||Percentage of participants|||Number
827881|NCT01204658|Primary|Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms Related to Vaccination – Primary Phase of the Study|Assessed solicited general symptoms were Drowsiness, Irritability, Loss of appetite (Loss Appet.) and Fever (rectal temperature higher than or equal to [>=] 38 degrees Celsius [°C]). Any = Occurrence of the specified solicited general symptom, regardless of intensity and relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 (G3) Drowsiness = Drowsiness that prevented normal activity. G3 Irritability = Crying that could not be comforted/prevented normal activity. G3 Loss of appetite = Subject did not eat at all. G3 Fever = Rectal temperature higher than (>) 40.0°C. Primary results correspond to results for occurrences of G3 fever symptoms assessed by the investigators as related to vaccination (Related G3 fever).|Within the 7-day (Days 0-6) periods post vaccination, after each dose (D) of the 3-dose primary vaccination course|The analysis was performed on the Total Vaccinated cohort for the Primary Phase, which included all subjects who received at least one of the 3 vaccine doses against pneumococcal diseases, with analysis done solely on subjects with post-vaccination solicited symptoms results available.||Subjects|||Number
827882|NCT01204671|Secondary|Number of Subjects With Any and Related Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE = any SAE regardless of intensity or relationship to vaccination. Related SAE = SAE assessed by the investigator as related to the vaccination.|From the beginning of the study (Day 0) to study end (Day 180)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subject|||Number
827883|NCT01204671|Secondary|Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) are a subset of adverse events that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Related pIMD = pIMD assessed by the investigator as related to the vaccination. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.|From the beginning of the study (Day 0) to study end (Day 180)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subject|||Number
827939|NCT01205269|Secondary|Forced Vital Capacity (FVC), Peak Effect Over 0 - 24 Hours Post-dose|Maximum FVC value|0, 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h|Of the 28 randomised patients, 27 completed the study and one discontinued during the last washout period. All 28 randomised patients were included in the analyses of all variables||L||Standard Deviation|Mean
836875|NCT01301079|Primary|Pain 120 Minutes|The scale measure pain after 120 minutes (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10.|120 minutes|||units on a scale||Standard Deviation|Mean
827885|NCT01204671|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|Unsolicited AEs cover any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any unsolicited AE = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 unsolicited AE = unsolicited AE that prevented normal everyday activity Related unsolicited AE = unsolicited AE assessed by the investigator as related to the vaccination.|Within the 21-day (Days 0-20) follow-up period after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subject|||Number
827886|NCT01204671|Secondary|Number of Days With Solicited General Symptoms|Assessed solicited general symptoms post vaccination were fatigue, gastrointestinal symptoms (Gastr.), headache, joint pain at other location (Joint Pain), muscle aches, shivering, and temperature [defined as axillary temperature above or equal to (> =) 37.5 degrees Celsius (°C)].|Within the 7-day (Days 0-6) follow-up period after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, solely on subjects with available results.||Day||Inter-Quartile Range|Median
827887|NCT01204671|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms post vaccination were fatigue, gastrointestinal symptoms (Gastr.), headache, joint pain at other location (Joint Pain), muscle aches, shivering, and temperature [axillary temperature above or equal to (>=) 37.5 degrees Celsius (°C)]. Any = occurrence of a symptom regardless of intensity or relationship to vaccination. Grade 3 = symptom which prevented normal every day activities. Grade 3 temperature = axillary temperature > 39°C. Related = symptom assessed as causally related to study vaccination.|Within the 7-day (Days 0-6) follow-up period after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, solely on subjects with available results.||Subject|||Number
827888|NCT01204671|Secondary|Number of Days With Solicited Local Symptoms|Assessed solicited local symptoms post vaccination were pain, redness and swelling at the injection site.|Within the 7-day (Days 0-6) follow-up period after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, solely on subjects with available results.||Day||Inter-Quartile Range|Median
827889|NCT01204671|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms.|Assessed solicited local symptoms post vaccination were pain, redness and swelling at the injection site. Any = occurrence of a symptom regardless of intensity. Grade 3 pain = significant pain at rest/ that prevented normal every day activities. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|Within the 7-day (Days 0-6) follow-up period after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, solely on subjects with available results.||Subject|||Number
827890|NCT01204671|Secondary|Increase in Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease|Increase in hemagglutination inhibition (HI) antibodies is presented in terms of mean geometric increase (MGI), defined as the geometric mean of the within subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer , expressed using “fold increase” as unit . Antibodies assessed were HI antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.|At Day 21 (D21)|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available, and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.||fold increase||95% Confidence Interval|Geometric Mean
827891|NCT01204671|Secondary|Number of Seroprotected Subjects Against 4 Strains of Influenza Disease|A seroprotected subject was a vaccinated subject who had hemagglutination inhibition (HI) antibody titer above or equal (>=) 1:40. Antibodies assessed were HI antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.|At Day 0 (D0), and at Day 21 (D21)|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available, and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.||Subject|||Number
827892|NCT01204671|Secondary|Number of Seropositive Subjects Against 4 Strains of Influenza Disease|A seropositive subject was a vaccinated subject with hemagglutination inhibition (HI) antibody titer above or equal (>=) the reference cut-off value of 1:10. Antibodies assessed were HI antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.|At Day 0 (D0), and at Day 21 (D21)|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available, and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.||Subject|||Number
827893|NCT01204671|Primary|Number of Seroconverted Subjects Against 4 Strains of Influenza Disease|A seroconverted subject was a vaccinated subject who had either a pre-vaccination hemagglutination inhibition (HI) antibody titer < 1:10 and a post-vaccination titer above or equal (>=) 1:40, or a pre-vaccination HI antibody titer >= 1:10 and at least a 4-fold increase in post-vaccination HI antibody titer. Antibodies assessed were HI antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.|At Day 21 (D21)|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available, and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.||Subject|||Number
827940|NCT01205269|Secondary|Forced Expiratory Volume in One Second (FEV1), Average Effect Over 0 - 24 Hours Post-dose|Average FEV1 value|0, 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h|Of the 28 randomised patients, 27 completed the study and one discontinued during the last washout period. All 28 randomised patients were included in the analyses of all variables||L||Standard Deviation|Mean
827894|NCT01204671|Primary|Titers for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. HI antibodies assessed were antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.|At Day 0 (D0), and at Day 21 (D21)|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available, and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.||Titer||95% Confidence Interval|Geometric Mean
827895|NCT01204697|Secondary|Duration of Response (DoR)|Duration of response (DoR) was defined as the interval (in days) from first documentation of a response (CR/PR depending on which occurred first) to the date of the first documentation of disease progression or death from any cause. Participants presenting a response were considered as censored at the date of the last assessment with a documentation of non-progression. DoR (days) = (Date of PD/death ‐ Date of CR/PR) + 1. Assessments were performed according to RECIST Version 1.1. DoR was assessed using the Kaplan‐Meier method. Detailed definitions of CR and PR are provided in Outcome Measure 4.|From randomization until progressive disease or death, assessed up to 18 months|FAS population. Here, number of participants analyzed signifies those participants who had a best overall response of CR or PR.||months||95% Confidence Interval|Median
827896|NCT01204697|Secondary|Percentage of Participants With Disease Control|Disease control was defined as PR, CR, or SD. Participants who did not achieve a CR or PR or SD were counted as non‐responders in the analysis of disease control. According to RECIST Version 1.1, SD was defined as not qualifying for CR, PR, and PD. Detailed definitions of CR and PR are provided in Outcome Measure 4.|From randomization until progressive disease or death, assessed up to 18 months|FAS population||percentage of participants||95% Confidence Interval|Number
827897|NCT01204697|Secondary|Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR)|Best overall response (complete response [CR]/partial response [PR]) was defined as the best response recorded from the start of the treatment until disease progression (PD). Best response in this trial was defined as the best response observed at any post-treatment visits. According to RECIST Version 1.1, CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than [<] 10 mm). No new lesions. PR was defined as greater than or equal to [>=] 30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.|From randomization until progressive disease or death, assessed up to 18 months|FAS population||percentage of participants||95% Confidence Interval|Number
827898|NCT01204697|Secondary|Overall Survival (OS)|Overall survival (OS) was defined as the interval (in days) between the date of randomization and death from any cause. Participants alive at the time of the analysis were censored at the date they were last known to be alive. OS was assessed using the Kaplan‐Meier method.|From randomization until death, assessed up to 18 months|FAS population||months||95% Confidence Interval|Median
827899|NCT01204697|Secondary|Progression-free Survival (PFS)|Progression-free Survival (PFS) was defined as the interval (in days) between the date of randomization and the first documentation of progressive disease or death from any cause. Participants alive and progression-free were considered as censored at the date of the last tumor assessment when the participant was known to be progression‐free. Participants without post‐baseline tumor assessment, but known to be alive, were censored at the time of randomization. PFS (days) = (Date of Event ‐ Date of Randomization) + 1. PFS was assessed using the Kaplan‐Meier method. Detailed definition of PD is provided in Outcome Measure 1.|From randomization until progressive disease or death, assessed up to 18 months|FAS population||months||95% Confidence Interval|Median
827900|NCT01204697|Primary|Percentage of Participants Free From Disease Progression or Death at 6 Months|According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1, progressive Disease (PD) is defined as: for Target Lesions - At least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). (Note: the appearance of one or more new lesions is also considered progression). For Non-Target Lesions - Unequivocal progression of existing non-target lesions. (Note: the appearance of one or more new lesions is also considered progression).|Month 6|FAS population||percentage of participants||95% Confidence Interval|Number
827901|NCT01204736|Primary|Elbow Extension Strength|Elbow extension strength was measured as the maximum elbow extension moment that subject's could generate. We used an elbow moment transducer to measure elbow moments under isometric (no change in arm posture) conditions. Subjects performed three trials at maximum effort, holding maximum elbow extension for 5 to 7 seconds. The maximum moment was computed as the maximum average moment sustained over a 0.5 second window.|At least one year post surgery|||Newton-Meters|Participants|Standard Deviation|Mean
827902|NCT01204775|Primary|Mean Change in HbA1c From Baseline to Week 16||16 week short term treatment period|||percentage||Standard Deviation|Mean
827903|NCT01204788|Primary|Number of Participants With Infection|Primary outcome is infection (yes/no) where participant without infection found by day 42 patient are counted as 'No' to infection.|Blood draw 2-3 times a week while hospitalized, weekly thereafter. Participant to remain on study 42 days after transfusion.|Outcomes inevaluable due to low recruitment.|||||
827917|NCT01205126|Secondary|Change From Baseline in Pain Relief, in the Past 24 Hour Recorded Assessed by BPI Short Form Questionnaire at Day 29|The BPI is questionnaire for evaluating the degree of pain severity and the impact of pain in performing daily routines. BPI comprises of total 9 items in total, and the 8th item consisting of 7 sub-items is a question asking the degree of disturbance due to pain. The score ranges from 0% to 100%, wherein 0% indicates no relief and 100% indicates complete relief.|Baseline and Day 29|The PPS included all randomly assigned participants who had completed all efficacy evaluations, have good compliance to the protocol without major protocol violations specified and who prematurely discontinued the study due to lack of efficacy were also included. Redefined LOCF was applied.||Units on a scale||Standard Deviation|Mean
827904|NCT01204853|Secondary|Number of Participants With Pharmacokinetic (PK) Parameters at Steady State|The following PK parameters at the steady state were evaluated: maximum observed concentration during the dosing interval (Cmax), time for maximum observed concentration during the dosing interval (Tmax), area under the plasma concentration-time curve over dosing interval tau for multiple dose (AUCtau), terminal elimination half-life (t1/2), apparent clearance (CL/F) and apparent volume of distribution during the terminal elimination phase (Vz/F) at Week 12/Termination (as data permit), and concentration predose during multiple dosing (Ctrough) at Week 2, 4, 8 and 12/Termination.|pre-dose at Week 2, 4, 8, and pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24 hours post-dose at Week 12 or study termination|"The PK concentration set was defined as all participants who have at least 1 concentration.
The PK parameter analysis set was defined as all participants who have at least 1 of PK parameters of interest.
Descriptive statistics for PK parameters were not calculated due to a small number of participants."||Participants|||Number
827905|NCT01204853|Secondary|Clinical Worsening|Clinical worsening is defined as 1) Hospitalization for worsening pulmonary arterial hypertension, 2) On-study death, 3) Heart-lung or lung transplantation, 4) Atrial septostomy, 5) Addition of the chronic medications for the treatment of worsening pulmonary arterial hypertension, and 6) Initiation of oxygen.|12 weeks|"Efficacy analysis set is defined as all participants who receive at least one dose of the study drug and had efficacy observations at baseline in any efficacy assessments.
Descriptive statistics for clinical worsening were not calculated due to a small number of participants."||Participants|||Number
827906|NCT01204853|Secondary|Change From Baseline in N-amino Terminal Fragment of the Prohormone Brain Natriuretic Peptide (NT-pro BNP)|Change from baseline in NT-pro BNP is calculated as the value at Week 12 minus value at baseline.|12 weeks|"Efficacy analysis set is defined as all participants who receive at least one dose of the study drug and had efficacy observations at baseline in any efficacy assessments.
Descriptive statistics for change from baseline in NT-pro BNP were not calculated due to a small number of participants."||pg/mL||Standard Deviation|Mean
827907|NCT01204853|Secondary|Number of Participants With Haemodynamics Parameters|"The following haemodynamic measurements were assessed: right arterial pressure, pulmonary arterial systolic pressure, pulmonary arterial diastolic pressure, mean pulmonary arterial pressure, pulmonary capillary wedge pressure, left ventricular-end diastolic pressure, cardiac output, systemic arterial blood pressure (systolic, diastolic and mean), and heart rate.
Change from baseline in haemodynamics parameters is calculated as the value at Week 12 minus value at baseline."|12 weeks|"Efficacy analysis set is defined as all participants who receive at least one dose of the study drug and had efficacy observations at baseline in any efficacy assessments.
Descriptive statistics for change from baseline in haemodynamics parameters were not calculated due to a small number of participants."||Participants|||Number
827908|NCT01204853|Secondary|Change From Baseline in WHO Functional Class|The change from baseline in WHO functional class was classified into “Improved”, “No change” and “Worsened”. The change from baseline in WHO functional class at Week 12 was to be summarized with frequency count and percentage in each category based on imputed data for missing values at Week 12.|12 weeks|"Efficacy analysis set is defined as all participants who receive at least one dose of the study drug and had efficacy observations at baseline in any efficacy assessments.
Descriptive statistics for change from baseline in WHO functional class were not calculated due to a small number of participants."||Percentage of participants|||Number
827909|NCT01204853|Primary|Change From Baseline in 6-minute Walk Distance|Change from baseline in 6-minute walk distance is calculated as the value at Week 12 minus value at baseline.|12 weeks|"Efficacy analysis set is defined as all participants who receive at least one dose of the study drug and had efficacy observations at baseline in any efficacy assessments.
Descriptive statistics for change from baseline in 6-minute walk distance were not calculated due to a small number of participants."||Meters||Standard Deviation|Mean
827910|NCT01204853|Primary|Number of Participants With Adverse Events|Number of participants with any adverse events, severe adverse events, serious adverse events|12 weeks|"Safety analysis set is defined as all participants who receive at least one dose of the study drug.
Descriptive statistics for adverse events were not calculated due to a small number of subjects."||Participant|||Number
827911|NCT01205035|Secondary|Angiographic Leakage From Baseline to Month 6 and 12|"Angiography was taken via fluorescein angiography. Any increases of angiographic leakage was counted between baseline and month 6. Also any decreases of angiographic leakage was counted between baseline and 6 month. The same was done between baseline and 12 month.
Any increase of angiographic leakage was counted as a +1. Likewise, any decrease of angiographic leakage was counted as a -1. The sum was calculated based on the number of participants in each arm and the total shown in the outcome. For example: if across the three injected participants for their 6 month visit, two of them showed an increase of angiographic leakage and one showed a decrease, then the outcome would be, (+1) + (+1) + (-1)= +1. Likewise, if the same three participant's 12 month visit showed two with a decrease in leakage and one with no changes in leakage, the outcome would be, (-1) + (-1) + (0)= -2"|Baseline to 6 and baseline to 12 months|||Sum of increases (+1) and decreases (-1)|||Number
827912|NCT01205035|Secondary|Number of Adverse Events Associated to the Administration of Ranibizumab 2.0mg||Baseline to 6 month, baseline to 9 month and baseline to 12 months|||Number of Adverse Events|||Number
827913|NCT01205035|Secondary|Change in Standard Central Subfield Thickness (CST) as Measured by OCT From Baseline to 6, 9, and 12 Months|A large decrease in CST thickness may be indicative of a worse clinical outcome. These measurements are done to ensure safety of the participants.|Baseline to 6, 9, and 12 months|||Micrometer||Full Range|Mean
827914|NCT01205035|Secondary|Change in Visual Acuity From Baseline to Month 6 and From Baseline to 9 Months||Baseline to 6 months and baseline to 9 months|||LogMAR Unit||Full Range|Mean
827915|NCT01205035|Primary|Visual Acuity Change From Baseline to Month 12 of the Study||Baseline to 12 months|||LogMAR Unit||Full Range|Mean
827916|NCT01205126|Secondary|Breakthrough Pain Medication (Rescue Medication) Doses Taken|Any breakthrough pain medication taken during the overall study was reported. Morphine hydrochloride was used as a rescue medication in case of breakthrough pain.|Baseline up to Day 29|The PPS included all randomly assigned participants who had completed all efficacy evaluations, have good compliance to the protocol without major protocol violations specified and who prematurely discontinued the study due to lack of efficacy. Redefined LOCF was applied. Here 'N' =number of participants who were evaluated for this outcome measure.||Doses||Standard Deviation|Mean
827918|NCT01205126|Secondary|Change From Baseline in Pain Right Now Assessed by BPI Short Form Questionnaire Score at Day 29|The BPI is questionnaire for evaluating the degree of pain severity and the impact of pain in performing daily routines. Change in Pain Right now in BPI was reported. The score ranges from 0=no pain to 10=pain as bad as participants could imagine.|Baseline and Day 29|The PPS included all randomly assigned participants who had completed all efficacy evaluations, have good compliance to the protocol without major protocol violations specified and who prematurely discontinued the study due to lack of efficacy were also included. Redefined LOCF was applied.||Units on a scale||Standard Deviation|Mean
827919|NCT01205126|Secondary|Change From Baseline in Average Pain, in the Past 24 Hours Assessed by BPI Short Form Questionnaire Score at Day 29|The BPI is questionnaire for evaluating the degree of pain severity and the impact of pain in performing daily routines. Change in average pain in the past 24 hours, in BPI score was reported. The score ranges from 0 to 10 wherein, 0 indicates no pain and 10 indicates pain as bad as participants could imagine.|Baseline and Day 29|The PPS included all randomly assigned participants who had completed all efficacy evaluations, have good compliance to the protocol without major protocol violations specified and who prematurely discontinued the study due to lack of efficacy were also included. Redefined LOCF was applied.||Units on a scale||Standard Deviation|Mean
827920|NCT01205126|Secondary|Change From Baseline in Pain at Its Least, in the Past 24 Hours Assessed by BPI Short Form Questionnaire Score at Day 29|The BPI is questionnaire for evaluating the degree of pain severity and the impact of pain in performing daily routines. Change in pain at its least, in the past 24 hours in BPI score was reported. The total score ranges from 0 to 10, wherein 0 indicates no pain and 10 indicates pain as bad as participants could imagine.|Baseline and Day 29|The PPS included all randomly assigned participants who had completed all efficacy evaluations, have good compliance to the protocol without major protocol violations specified and who prematurely discontinued the study due to lack of efficacy were also included. Redefined LOCF was applied.||Units on a scale||Standard Deviation|Mean
827921|NCT01205126|Primary|Change From Baseline in Worst Pain in the Past 24 Hours Assessed by Brief Pain Inventory (BPI) Short Form Questionnaire Score at Day 29|The BPI is questionnaire for evaluating the degree of pain severity and the impact of pain in performing daily routines. Change in worst pain in the past 24 hours in BPI score was reported. The total score ranges from 0 to 10, wherein 0 indicates no pain and 10 indicates pain as bad as participants could imagine.|Baseline and Day 29|Per protocol set (PPS) included all randomly assigned participants who had completed all efficacy evaluations, and participants who prematurely discontinued the study due to lack of efficacy were also included. Redefined last observation carried forward (LOCF) was applied. Redefined LOCF is LOCF prior to over dose rescue medication.||Units on a scale||Standard Deviation|Mean
827922|NCT01205230|Secondary|Number of Participants With the Indicated Event of Dose Limiting Toxicity (DLT)|The following were considered DLTs only while participants were receiving pazopanib co-administered with either ketoconazole or esomeprazole: Grade 4 hematologic toxicities, excluding lymphopenia; and Grade 3/4 non-hematologic toxicities, excluding alopecia and nausea/vomiting/diarrhea for which adequate supportive therapy had not been instituted. Toxicities observed once co-administration of pazopanib with ketoconazole or esomeprazole was complete (after Day 5 of Period 2) could also be considered DLTs if judged to be relevant by the investigator and the GlaxoSmithKline Medical Monitor.|From Baseline (Day 1) to a maximum of 4 weeks after the last dose of study drug was administered (on Study Day 12)|All Treated Population. Per protocol, a DLT could not occur during single-agent pazopanib administration in Period 1; thus, data were only collected and analyzed for those participants receiving pazopanib co-administered with either ketoconazole or esomeprazole in Period 2.||participants|||Number
827923|NCT01205230|Secondary|Number of Participants With the Indicated Grade 3 or 4 Adverse Events (AEs)|AEs were graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.0. Grades range from 0 (no toxicity) to 4 (life-threatening or disabling). A Grade 3 AE is severe; defined as considerable interference with the participant’s daily activities, medical intervention/therapy required, and hospitalization possible. A Grade 4 AE is life-threatening; defined as extreme limitation in activity, significant medical intervention/therapy required, and hospitalization probable.|From Baseline (Day 1) to a maximum of 4 weeks after the last dose of study drug was administered (on Study Day 12)|All Treated Population: all participants who were enrolled into the study and received at least one dose of study drug||participants|||Number
827924|NCT01205230|Secondary|Plasma Ketoconazole Concentration at the Indicated Time Points|Blood samples for the determination of plasma ketoconazole concentrations were collected before (pre-dose [within 60 minutes prior to pazopanib administration]) and after the final pazopanib and ketoconazole dose (fifth dose) during Period 2 at the indicated time points, relative to pazopanib administration (at 1 and 2 hours after pazopanib administration). Blood samples were obtained via peripheral intravenous cannula or central line. Concentrations of ketoconazole were determined in plasma samples using the currently approved analytical methodology.|Day 5 of Period 2 (combination therapy). Blood samples were collected within 60 minutes prior to pazopanib administration and 1 and 2 hours after pazopanib administration.|PK Population||mcg/mL||Full Range|Mean
827925|NCT01205230|Secondary|Tmax for the Indicated Metabolites of Pazopanib When Administered Alone or in Combination With Ketoconazole and Ezomeprazole|Blood samples for PK analysis of pazopanib were obtained at pre-dose (within 60 minutes prior to pazopanib administration) and at 1, 2, 3, 4, 6, 8, and 24 hours after pazopanib administration. From the plasma concentration-time curve, the PK parameter tmax was determined by standard non-compartmental analysis using WinNonlin. Nominal data collection time points (TPs) were defined in the protocol; however, the actual data collection TP often differed slightly from the nominal TP for various reasons. This leads to medians and ranges that don't coincide with planned nominal data collection TPs.|Day 7 of Period 1 (monotherapy) and Day 5 (Study Day 12) of Period 2 (combination therapy). Blood samples were obtained within 60 minutes prior to pazopanib administration and at 1, 2, 3, 4, 6, 8, and 24 hours after pazopanib administration.|PK Population||hr||Full Range|Median
827937|NCT01205269|Secondary|Diastolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose|Average diastolic blood pressure value|0, 30 min, 2 h, 4 h|Of the 28 randomised patients, 27 completed the study and one discontinued during the last washout period. All 28 randomised patients were included in the analyses of all variables||mmHg||Standard Deviation|Mean
836876|NCT01301079|Primary|Pain 90 Minutes|The scale measure pain after 90 minutes (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10.|90 minutes|||units on a scale||Standard Deviation|Mean
827926|NCT01205230|Secondary|Plasma Cmax for the Indicated Metabolites of Pazopanib When Administered Alone or in Combination With Ketoconazole and Ezomeprazole|Blood samples for PK analysis of the metabolites of pazopanib were obtained at pre-dose (within 60 minutes prior to pazopanib administration) and at 1, 2, 3, 4, 6, 8, and 24 hours after pazopanib administration. From the plasma concentration-time curve, the PK parameter Cmax was determined by standard non-compartmental analysis using WinNonlin. The concentration-time curve is the result of time points of blood sampling and its measured concentration of pazopanib in the plasma.|Day 7 of Period 1 (monotherapy) and Day 5 (Study Day 12) of Period 2 (combination therapy). Blood samples were obtained within 60 minutes prior to pazopanib administration and at 1, 2, 3, 4, 6, 8, and 24 hours after pazopanib administration.|PK Population||mcg/mL||95% Confidence Interval|Geometric Mean
827927|NCT01205230|Secondary|Plasma AUC(0-24) for the Indicated Metabolites of Pazopanib When Administered Alone or in Combination With Ketoconazole and Ezomeprazole|Blood samples for PK analysis of the metabolites of pazopanib were obtained at pre-dose (within 60 minutes prior to pazopanib administration) and at 1, 2, 3, 4, 6, 8, and 24 hours after pazopanib administration. From the plasma concentration-time curve, the PK parameter AUC(0-24) was determined by standard non-compartmental analysis using WinNonlin. Plasma AUC(0-24) is a measure of the amount of drug a participant has been exposed to in 24 hours.|Day 7 of Period 1 (monotherapy) and Day 5 (Study Day 12) of Period 2 (combination therapy). Blood samples were obtained within 60 minutes prior to pazopanib administration and at 1, 2, 3, 4, 6, 8, and 24 hours after pazopanib administration.|PK Population. One participant from the Pazopanib + Ketoconazole treatment arm was not analyzed for GSK1071306 due to mishandling of PK samples during shipping. Only those participants providing samples were analyzed.||hr*mcg/mL||95% Confidence Interval|Geometric Mean
827928|NCT01205230|Secondary|Plasma Concentration at 24 Hours After Administration (C24) of Pazopanib Alone and of Pazopanib in Combination With Ketoconazole and Esomeprazole|Pazopanib plasma concentration-time data were analyzed by non-compartmental methods with WinNonlin. Calculations were based on the actual sampling times. From the plasma concentration-time data, the PK parameter C24 was determined.|Day 7 of Period 1 (monotherapy) and Day 5 (Study Day 12) of Period 2 (combination therapy). Blood samples were obtained 24 hours after administration of pazopanib.|PK Population||mcg/mL||95% Confidence Interval|Geometric Mean
827929|NCT01205230|Primary|Time of Occurrence of Cmax (Tmax) of Pazopanib Alone and of Pazopanib in Combination With Ketoconazole and Esomeprazole|Blood samples for PK analysis of pazopanib were obtained at pre-dose (within 60 minutes prior to pazopanib administration) and at 1, 2, 3, 4, 6, 8, and 24 hours after pazopanib administration. From the plasma concentration-time curve, the PK parameter tmax was determined by standard non-compartmental analysis using WinNonlin. Nominal data collection time points (TPs) were defined in the protocol; however, the actual data collection TP often differed slightly from the nominal TP for various reasons. This leads to medians and ranges that don't coincide with planned nominal data collection TPs.|Day 7 of Period 1 (monotherapy) and Day 5 (Study Day 12) of Period 2 (combination therapy). Blood samples were obtained within 60 minutes prior to pazopanib administration and at 1, 2, 3, 4, 6, 8, and 24 hours after pazopanib administration.|PK Population||hours (hr)||Full Range|Median
827930|NCT01205230|Primary|Plasma Maximum Observed Concentration (Cmax) of Pazopanib Alone and of Pazopanib in Combination With Ketoconazole and Esomeprazole|Blood samples for PK analysis of pazopanib were obtained at pre-dose (within 60 minutes prior to pazopanib administration) and at 1, 2, 3, 4, 6, 8, and 24 hours after pazopanib administration. From the plasma concentration-time curve, the PK parameter Cmax was determined by standard non-compartmental analysis using WinNonlin. The concentration-time curve is the result of time points of blood sampling and its measured concentration of pazopanib in the plasma.|Day 7 of Period 1 (monotherapy) and Day 5 (Study Day 12) of Period 2 (combination therapy). Blood samples were obtained within 60 minutes prior to pazopanib administration and at 1, 2, 3, 4, 6, 8, and 24 hours after pazopanib administration.|PK Population||mcg/mL||95% Confidence Interval|Geometric Mean
827931|NCT01205230|Primary|Plasma Pazopanib Area Under the Concentration-time Curve From Zero (Pre-dose) to 24 Hours (AUC[0-24]) of Pazopanib Alone and of Pazopanib in Combination With Ketoconazole and Esomeprazole|Blood samples for pharmacokinetic (PK) analysis of pazopanib were obtained at pre-dose (within 60 minutes prior to pazopanib administration) and at 1, 2, 3, 4, 6, 8, and 24 hours after pazopanib administration. From the plasma concentration-time curve, the PK parameter AUC(0-24) was determined by standard non-compartmental analysis using WinNonlin. Plasma AUC(0-24) is a measure of the amount of drug a participant has been exposed to in 24 hours.|Day 7 of Period 1 (monotherapy) and Day 5 (Study Day 12) of Period 2 (combination therapy). Blood samples were obtained within 60 minutes prior to pazopanib administration and at 1, 2, 3, 4, 6, 8, and 24 hours after pazopanib administration.|Pharmacokinetic (PK) Population: all participants who underwent plasma PK sampling and had evaluable PK assay results from at least one analyte||Hour*micrograms/milliliters (hr*mcg/mL)||95% Confidence Interval|Geometric Mean
827932|NCT01205269|Secondary|Plasma AZD8683 AUC0-24|Area under the AZD8683 plasma concentration curve from 0 to 24 hours|0, 5 min, 15 min, 30 min, 45 min, 1 h, 90 min, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h|Plasma concentrations were below the LLOQ for all post-dose samples for some patients and treatments. PK parameters for these 3 treatments have been set to missing and are not included in the descriptive statistics.||nmol*h/L||Full Range|Geometric Mean
827933|NCT01205269|Secondary|Plasma AZD8683 Cmax|Maximum plasma concentration of AZD8683|0, 5 min, 15 min, 30 min, 45 min, 1 h, 90 min, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h|Plasma concentrations were below the LLOQ for all post-dose samples for some patients and treatments. PK parameters for these 3 treatments have been set to missing and are not included in the descriptive statistics.||nmol/L||Full Range|Geometric Mean
827934|NCT01205269|Secondary|QTcF, Average Effect Over 0 - 4 Hours Post-dose|Average QTcF value. QTcF = QT interval corrected for heart rate using Fridericia's formula|0, 30 min, 2 h, 4 h|Of the 28 randomised patients, 27 completed the study and one discontinued during the last washout period. All 28 randomised patients were included in the analyses of all variables||ms||Standard Deviation|Mean
827935|NCT01205269|Secondary|Heart Rate, Average Effect Over 0 - 4 Hours Post-dose|Average heart rate value|0, 30 min, 2 h, 4 h|Of the 28 randomised patients, 27 completed the study and one discontinued during the last washout period. All 28 randomised patients were included in the analyses of all variables||bpm||Standard Deviation|Mean
827936|NCT01205269|Secondary|Pulse, Average Effect Over 0 - 4 Hours Post-dose|Average pulse value|0, 30 min, 2 h, 4 h|Of the 28 randomised patients, 27 completed the study and one discontinued during the last washout period. All 28 randomised patients were included in the analyses of all variables||bpm||Standard Deviation|Mean
827941|NCT01205269|Primary|Forced Expiratory Volume in One Second (FEV1), Average Effect Over 22 - 26 Hours Post-dose|Trough FEV1 value|22 h, 24 h, 26 h|Of the 28 randomised patients, 27 completed the study and one discontinued during the last washout period. All 28 randomised patients were included in the analyses of all variables||L||Standard Deviation|Mean
827942|NCT01205269|Primary|Forced Expiratory Volume in One Second (FEV1), Peak Effect Within 0 - 24 Hours Post-dose|Maximum FEV1 value|0, 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h|Of the 28 randomised patients, 27 completed the study and one discontinued during the last washout period. All 28 randomised patients were included in the analyses of all variables||L||Standard Deviation|Mean
827943|NCT01205399|Secondary|Procedural Time for AlloMax Surgical Graft Placement.|Procedure time will be defined as beginning when the Investigator made the initial incision and ending when the skin closure was completed (skin to skin).|0 Days|All enrolled subjects that could be verified through historical medical record review.||minutes||Standard Deviation|Mean
827944|NCT01205399|Secondary|Complications in Subjects With Hernias Repaired With an AlloMax Surgical Graft.|Complications will be assessed by evaluation of the procedural and device related adverse events (AEs) documented in the subject’s medical files from the time surgery was initiated until the day the subject had a postoperative visit.|9+ Months|All enrolled subjects that could be verified through historical medical record review.||complication events|||Number
827945|NCT01205399|Primary|Number of Subjects With Hernia Recurrence Post Repair With an AlloMax Surgical Graft|A recurrent hernia is a hernia, confirmed by the Investigator at any point after surgery, in the same location as the hernia repaired in the index procedure.|9 + Months|All enrolled subjects that could be verified through historical medical record review.||participants|||Number
827946|NCT01205451|Secondary|Mean Change From Baseline in Pulse Rate at the Exit Visit|The pulse rate of participants was recorded. Change from Baseline was calculated as the value at the exit visit (Week 12 or earlier) minus the value at Baseline.|Baseline (Screening) and the exit visit (Week 12 or earlier)|Safety Set Population. Only those participants for whom data were available for both the Baseline and exit visits were analyzed.||beats per minute||Standard Deviation|Mean
827947|NCT01205451|Secondary|Mean Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at the Exit Visit|Systolic blood pressure (SBP) and diastolic BP of participants were measured in the sitting position. Change from Baseline was calculated as the value at the exit visit (Week 12 or earlier) minus the value at Baseline.|Baseline (Day 0) and the exit visit (Week 12 or earlier)|Safety Set Population. Only those participants for whom data were available for both the Baseline and exit visits were analyzed.||Millimeters of mercury (mmHg)||Standard Deviation|Mean
827948|NCT01205451|Secondary|Number of Participants With Clinically Significant Abnormalities of Urinalysis at the Screening and Exit Visits|Urine samples of participants were collected for urinalysis, including measuring protein, blood, leukocyte, glucose, and urobilinogen. All values out of the normal range were evaluated by the investigator. Classification of clinically significant and not clinically significant was based on the investigator’s clinical judgment; no specific criteria were used.|Screening visit (-Week 1) and the exit visit (Week 12 or earlier)|Safety Set Population. Only those participants for whom data were available for both the Screening and exit visits were analyzed.||participants|||Number
827949|NCT01205451|Secondary|Mean Change From Baseline in Serum Blood Urea Nitrogen (BUN), Fasting Blood Glucose (FBG), Sodium, Potassium, Chloride, Total Cholesterol, and Triglyceride Values at the Exit Visit|Blood samples of participants were collected for biochemical tests of BUN, FBG, electrolytes, cholesterol, and triglycerides. The BUN test is primarily used to evaluate kidney function. Electrolytes include sodium, potassium, and chloride. Change from Baseline was calculated as the value at the exit visit minus the value at Baseline.|Baseline (Day 0) and the exit visit (Week 12 or earlier)|Safety Set Population. Only those participants for whom data were available for both the Baseline and exit visits were analyzed.||Millimoles per Liter (mmol/L)||Standard Deviation|Mean
827950|NCT01205451|Secondary|Mean Change From Baseline in Serum Creatinine, Uric Acid, and Total Bilirubin Values at the Exit Visit|Blood samples of participants were collected for a biochemical test of creatine, uric acid, and total bilirubin. Creatine and uric acid are evaluated for kidney function. The liver function test includes total bilirubin. Change from Baseline was calculated as the value at the exit visit (Week 12 or earlier) minus the value at Baseline.|Baseline (Day 0) and the exit visit (Week 12 or earlier)|Safety Set Population. Only those participants for whom data were available for both the Baseline and exit visits were analyzed.||Micromoles per Liter (μmol/L)||Standard Deviation|Mean
827951|NCT01205451|Secondary|Mean Change From Baseline in Serum Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (y-GT), and Alkaline Phosphatase (ALP) Values at the Exit Visit|Blood samples of participants were collected and evaluated for liver function, including measuring ALT, AST, y-GT, and ALP. Change from Baseline was calculated as the value at the exit visit (Week 12 or earlier) minus the value at Baseline.|Baseline (Day 0) and the exit visit (Week 12 or earlier)|Safety Set Population. Only those participants for whom data were available for both the Baseline and exit visits were analyzed.||International Units per Liter (IU/L)||Standard Deviation|Mean
827952|NCT01205451|Secondary|Mean Change From Baseline in Total Protein and Albumin Values at the Exit Visit|Blood samples of participants were collected for a biochemical test of total protein and albumin, at Baseline and at the exit visit. Change from Baseline was calculated as the value at the exit visit (Week 12 or earlier) minus the value at Baseline.|Baseline (Day 0) and the exit visit (Week 12 or earlier)|Safety Set Population. Only those participants for whom data were available for both the Baseline and exit visits were analyzed.||grams/L||Standard Deviation|Mean
827953|NCT01205451|Secondary|Mean Change From Baseline in Hematocrit Value at the Exit Visit|The hematocrit, also called packed cell volume or erythrocyte volume fraction, is the volume percentage of red blood cells in the blood. Change from Baseline was calculated as the value at the exit visit (Week 12 or earlier) minus the value at Baseline.|Baseline (Day 0) and the exit visit (Week 12 or earlier)|Safety Set Population. Only those participants for whom data were available for both the Baseline and exit visits were analyzed.||percentage||Standard Deviation|Mean
827965|NCT01205503|Secondary|B-type Natriuretic Peptide (BNP) Blood Levels in Patients Receiving Doxorubicin Containing Chemotherapy|Continuous Measure of BNP at the 4 time points outlined in protocol for each of the groups. This is a 32-amino acid polypeptide secreted by heart ventricles in response to excessive stretching of cardiomyocytes.|prior to and 3 hours post doxorubicin and between cycles 1 and 2|||pg/ml||95% Confidence Interval|Geometric Mean
827954|NCT01205451|Secondary|Mean Change From Baseline in Hemoglobin Content at the Exit Visit|Blood samples of participants were collected and evaluated for hemoglobin at Baseline and at the exit visit. Change from Baseline was calculated as the value at the exit visit (Week 12 or earlier) minus the value at Baseline.|Baseline (Day 0) and the exit visit (Week 12 or earlier)|Safety Set Population. Only those participants for whom data were available for both the Baseline and exit visits were analyzed.||Grams per Liter (grams/L)||Standard Deviation|Mean
827955|NCT01205451|Secondary|Mean Change From Baseline in the Percentage of Neutrophils, the Percentage of Lymphocytes, the Percentage of Monocytes, the Percentage of Eosinophils, and the Percentage of Basophils at the Exit Visit|Blood samples of participants were collected and evaluated for the percentage of neutrophils, lymphocytes, monocytes, eosinophils, and basophils comprising the total WBC count in the blood at Baseline and at the exit visit. Change from Baseline was calculated as the value at the exit visit (Week 12 or earlier) minus the value at Baseline.|Baseline (Day 0) and the exit visit (Week 12 or earlier)|Safety Set Population. Only those participants for whom data were available for both the Baseline and exit visits were analyzed.||Percentage of the total WBC||Standard Deviation|Mean
827956|NCT01205451|Secondary|Mean Change From Baseline in White Blood Cell (WBC) and Platelet Count at the Exit Visit|Blood samples of participants were collected and evaluated for WBC count and platelet count at Baseline and at the exit visit. Change from Baseline was calculated as the value at the exit visit (Week 12 or earlier) minus the value at Baseline.|Baseline (Day 0) and the exit visit (Week 12 or earlier)|Safety Set Population. Only those participants for whom data were available for both the Baseline and exit visits were analyzed.||10^9 cells per Liter||Standard Deviation|Mean
827957|NCT01205451|Secondary|Mean Change From Baseline in Red Blood Cell (RBC) Count at the Exit Visit|Blood samples of participants were collected and evaluated for RBC count at Baseline and at the exit visit. Change from Baseline was calculated as the value at the exit visit (Week 12 or earlier) minus the value at Baseline.|Baseline (Day 0) and exit visit (Week 12 or earlier)|Safety Set Population: all enrolled and treated participants. Only those participants for whom data were available for both the Baseline and exit visits were analyzed.||10^12 cells per Liter||Standard Deviation|Mean
827958|NCT01205451|Secondary|GAS Score as Evaluated by the Care Giver or the Participant at Week 6 and Week 12|The care giver or participant used the GAS to assess response to treatment at each visit after injection. The assessor was the same throughout the study period. GAS scores were assessed by using the 9-point GAS (-4, -3, -2, -1, -0, +1, +2, +3, +4; -4=very marked worsening, 0=unchanged, +4=very marked improvement) at Week 6 and Week 12.|Week 6 and Week 12|FAS Population. The missing data imputation method was used for analysis.||scores on a scale||Standard Deviation|Mean
827959|NCT01205451|Secondary|Global Assessment Scale (GAS) Score as Evaluated by the Physician at Week 6 and Week 12|The physician used the GAS to assess response to treatment at each visit after injection. The assessor was the same throughout the study period. GAS scores were assessed by using the 9-point GAS (-4, -3, -2, -1, -0, +1, +2, +3, +4; -4=very marked worsening, -0=unchanged, +4=very marked improvement) at Week 6 and Week 12.|Week 6 and Week 12|FAS Population. The missing data imputation method was used for analysis.||scores on a scale||Standard Deviation|Mean
827960|NCT01205451|Secondary|Change From Baseline at Week 6 and Week 12 for the Principal Measure as Assessed on the Disability Assessment Scale (DAS)|The investigator assessed 4 areas of disability, hygiene, pain, dressing, and limb posture, using the 4-point DAS (0=No functional disability to 3=Severe disability). Prior to the first dose, the investigator, in consultation with the participant, selected 1functional disability item (which had to have a score of 2 or greater as measured on the DAS, indicating moderate to severe disability) from the 4 areas of disability and assessed it as a principal measure. Change from Baseline at Week 6 or Week 12 was calculated as the value at Week 6 or Week 12 minus the value at Baseline.|Baseline (Day 0), Week 6, and Week 12|FAS Population. The missing data imputation method was used for analysis.||scores on a scale||Standard Deviation|Mean
827961|NCT01205451|Secondary|Change From Baseline at Week 6 and Week 12 for Thumb Flexor Muscle Tone as Measured on the MAS|The investigator or assessor extended the participant's thumb as quickly as possible to grade the flexor muscle tone. The MAS thumb score was calculated by using the 6-point MAS (0, 1, 1+ [regarded as 1.5], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part[s] rigid in flexion/extension). Change from Baseline at Week 6 or Week 12 was calculated as the value at Week 6 or Week 12 minus the value at Baseline.|Baseline (Day 0), Week 6, and Week 12|FAS Population. Only those participants who had thumb spasticity were analyzed. The missing data imputation method was used for analysis.||scores on a scale||Standard Deviation|Mean
827962|NCT01205451|Secondary|Change From Baseline at Week 6 and Week 12 for Finger Flexor Muscle Tone as Measured on the MAS|The investigator or assessor extended the participant's finger as quickly as possible to grade the flexor muscle tone. The MAS finger score was calculated by using the 6-point MAS (0, 1, 1+ [regarded as 1.5], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part[s] rigid in flexion/extension). Change from Baseline at Week 6 or Week 12 was calculated as the value at Week 6 or Week 12 minus the value at Baseline.|Baseline (Day 0), Week 6, and Week 12|FAS Population. The missing data imputation method was used for analysis.||scores on a scale||Standard Deviation|Mean
827963|NCT01205451|Secondary|Number of Participants Classified as Wrist Treatment Responders at Week 6 and Week 12|Wrist treatment responders are defined as participants with a decrease in wrist flexor muscle tone of at least one point on the MAS from Baseline. The MAS wrist score was calculated by using the 6-point MAS (0, 1, 1+ [regarded as 1.5], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part[s] rigid in flexion/extension).|Baseline (Day 0), Week 6, and Week 12|FAS Population. The missing data imputation method was used for analysis.||participants|||Number
827964|NCT01205451|Primary|Change From Baseline at Week 6 and Week 12 for Wrist Flexor Muscle Tone as Measured on the Modified Ashworth Scale (MAS)|The investigator or assessor extended the participant's wrist as quickly as possible to grade flexor muscle tone. The MAS wrist score was calculated by using the 6-point MAS (0, 1, 1+ [regarded as 1.5], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part[s] rigid in flexion/extension). Change from Baseline at Week 6 or Week 12 was calculated as the value at Week 6 or Week 12 minus the value at Baseline.|Baseline (Day 0), Week 6, and Week 12|Full Analysis Set (FAS) Population: all randomized and treated participants with at least one post-treatment MAS wrist score. The missing data imputation method was used for analysis. For each participant, missing data points were replaced by the mean of the non-missing scores from both treatment groups for that variable at the specific visit.||scores on a scale||Standard Deviation|Mean
827967|NCT01205503|Secondary|Plasma HNE Percent Changes From Baseline in Patients Receiving Doxorubicin Containing Chemotherapy|Continuous Measure of the percent change from baseline of Plasma HNE at the 4 time points outlined in the protocol for each group. All measurements after naive baseline were adjusted as percent change from each individual's baseline measure.|prior to and 3 hours post doxorubicin and between cycles 1 and 2|||Percent Change from Baseline||95% Confidence Interval|Geometric Mean
827968|NCT01205503|Secondary|Protein Carbonyl Percent Changes From Baseline in Patients Receiving Doxorubicin Containing Chemotherapy|Continuous Measure of percent changes from baseline of Protein Carbonyl at the 4 time points outlined in the protocol for each group. All measurements after naive baseline were adjusted as percent change from each individual's baseline measure.|prior to and 3 hours post doxorubicin and between cycles 1 and 2|||Percent Change from Baseline||95% Confidence Interval|Geometric Mean
827969|NCT01205503|Primary|TNF-alpha Levels in Patients Receiving Doxorubicin Containing Chemotherapy|Continuous Measure of TNF-alpha at the 4 time points outlined in the protocol for each group.|prior to and 3 hours post doxorubicin and between cycles 1 and 2|||log(pg/ml)||95% Confidence Interval|Geometric Mean
827970|NCT01205581|Secondary|Comparison of Geometric Mean Ratios (GMR) by HAI|"GMTs compared to each other as a ratio of the pre- and post-vaccine titers and as the ratio post-last dose to 9 months later.
GMRs were compared pre- to post-vaccination and post- vaccination to 9 months later."|Pre-vaccination, post-vaccination and 9 months after vaccination|Two patients in the HIV-HD group were excluded because data was only available at baseline. These 2 patients were lost for follow-up before evaluation for post-vaccine immune response.||Ratio|||Number
827971|NCT01205581|Secondary|Comparison of Geometric Mean Titer (GMT) by HAI|Serum antibody levels expressed as the reciprocal of the dilution needed to inhibit hemagglutination in vitro.|Pre-vaccination, post-vaccination and 9 months after vaccination|Two patients in the HIV-HD group were excluded because data was only available at baseline. These 2 patients were lost for follow-up before evaluation for post-vaccine immune response.||Titers||Full Range|Geometric Mean
827972|NCT01205581|Secondary|Number of Systemic Reactogenicity Events After Second Dose|Number of moderate or greater systemic reactogenicity event associated with the administration of Fluzone or FluzoneHD. Systemic reactions were defined as muscle ache, fatigue, or fever.|First 14 days after vaccination|||Events|||Number
827973|NCT01205581|Secondary|Number of Systemic Reactogenicity Events After First Dose|Number of moderate or greater systemic reactogenicity event associated with the administration of Fluzone or FluzoneHD. Systemic reactions were defined as muscle ache, fatigue, or fever.|First 14 days after vaccination|||Events|||Number
827974|NCT01205581|Secondary|Number of Local Reactogenicity Events After Second Dose|Number of moderate or greater local reactogenicity events associated with the administration of Fluzone or FluzoneHD. Local reactions were defined as pain, redness, or induration.|First 14 days after vaccination|||Events|||Number
827975|NCT01205581|Secondary|Number of Local Reactogenicity Events After First Dose|Number of moderate or greater local reactogenicity events associated with the administration of Fluzone or FluzoneHD. Local reactions were defined as pain, redness, or induration.|First 14 days after vaccination|||Events|||Number
827976|NCT01205581|Secondary|Rate of Vaccine Response by Seroprotection Compared by Absolute Lymphocyte Count (ALC)|The relationship between baseline lymphocyte numbers/function and robustness of the immune response will be described through descriptive analysis of relationships between pre-defined variables.|ALC at baseline and vaccine response at least 21 days after last dose of vaccine|30 participants did not have ALC data collected at baseline evaluation because they had complete blood count (CBC) ordered without differential count.||percentage of participants|||Number
827977|NCT01205581|Primary|Number of Participants Achieving Seroprotection After Second Dose of Vaccine|The immune response of Fluzone HD to Fluzone was determined using the hemagglutination-inhibition (HAI) assay to each of the 3 antigens contained in the vaccine: H1, H3 and B. Seroprotection was defined as a post-vaccine HAI titer ≥40.|21 to 42 days after second dose|Two patients in the HIV-HD group were excluded because data was only available at baseline. These 2 patients were lost for follow-up before evaluation for post-vaccine immune response.||number of participants|||Number
827978|NCT01205581|Primary|Rate of Seroprotection After 1 Dose of Vaccine|The immune response of Fluzone HD to Fluzone was determined using the hemagglutination-inhibition (HAI) assay to each of the 3 antigens contained in the vaccine: H1, H3 and B. Seroprotection was defined as a post-vaccine HAI titer ≥40.|at least 21 days after first dose, which is given at the time of baseline evaluation visit, and prior to second dose|Two patients in the HIV-HD group were excluded because data was only available at baseline. These 2 patients were lost for follow-up before evaluation for post-vaccine immune response.||Percentage of participants|||Number
827979|NCT01205581|Secondary|Rate of Vaccine Response by Seroconversion Compared by Absolute Lymphocyte Count (ALC)|The relationship between baseline lymphocyte numbers/function and robustness of the immune response will be described through descriptive analysis of relationships between pre-defined variables.|ALC at baseline and vaccine response at least 21 days after last dose of vaccine|30 participants did not have ALC data collected at baseline evaluation because they had complete blood count (CBC) ordered without differential count.||percentagae of participants|||Number
827980|NCT01205581|Secondary|Rate of Sero-conversion for 1 Dose vs. 2 Doses of Fluzone SD|"The rate of seroconversion to the 3 antigens contained in the vaccine was determined by hemagglutination-inhibition test and was compared by disease.
The immune response of 1 dose vs. 2 doses of Fluzone SD was determined using the hemagglutination-inhibition (HAI) assay to each of the 3 antigens contained in the vaccine: H1, H3 and B. Seroconversion was defined as a post-vaccine HAI titer ≥40 if baseline was <10, or a 4-fold rise in HAI titer if the baseline ≥10."|at least 21 days after each dose of vaccine|||percentrage of participants|||Number
827981|NCT01205581|Secondary|Rate of Sero-conversion for 1 Dose vs. 2 Doses of Fluzone HD|"The rate of seroconversion to the 3 antigens contained in the vaccine was determined by hemagglutination-inhibition test and was compared by disease.
The immune response of 1 dose vs. 2 doses of Fluzone HD was determined using the hemagglutination-inhibition (HAI) assay to each of the 3 antigens contained in the vaccine: H1, H3 and B. Seroconversion was defined as a post-vaccine HAI titer ≥40 if baseline was <10, or a 4-fold rise in HAI titer if the baseline ≥10."|at least 21 days after each dose of vaccine|Two patients in the HIV-HD group were excluded because data was only available at baseline. These 2 patients were lost for follow-up before evaluation for post-vaccine immune response.||percentage of participants|||Number
827982|NCT01205581|Secondary|Number of Participants Reporting Grade 3 and Grade 4 Adverse Events Possibly, Probably, or Definitely Attributable to Fluzone or Fluzone HD|Number of participants reporting grade 3 and grade 4 adverse events possibly, probably, or definitely attributable to Fluzone or Fluzone HD.|From initial vaccine administration through up to 8 months|Adverse events of Fluzone HD and Fluzone are provided as combined data from cancer and HIV patients, since there is no reason to believe one group is more susceptible to adverse events than the other.||participants|||Number
827983|NCT01205581|Primary|Rate of Seroconversion After 1 Dose of Vaccine|The immune response of Fluzone HD to Fluzone was determined using the hemagglutination-inhibition (HAI) assay to each of the 3 antigens contained in the vaccine: H1, H3 and B. Seroconversion was defined as a post-vaccine HAI titer ≥40 if baseline was <10, or a 4-fold rise in HAI titer if the baseline ≥10.|at least 21 days after first dose, which is given at the time of baseline evaluation visit, and prior to second dose|Two patients in the HIV-HD group were excluded because data was only available at baseline. These 2 patients were lost for follow-up before evaluation for post-vaccine immune response.||percentage of participants|||Number
827984|NCT01205646|Secondary|Changes in Bone Turnover Markers||Four weeks after initiating zoledronte therapy||||||
827985|NCT01205646|Secondary|Evaluate Changes in Bone Scans||Four weeks after initiating zoledronate therapy||||||
827986|NCT01205646|Secondary|Evaluate the Change in PSA After Zoledronate Therapy||Four weeks after initiating Zoledronate therapy||||||
827987|NCT01205646|Primary|PET Response Rate in Metastatic Prostate Cancer Patients Treated With Zoledronate Therapy.|PET response rate was pre-defined in Section 5.0 of the protocol based on the magnitude of change in the mean standardized uptake value (SUVmean), which is measured at each PET scan. Specifically, a decline in SUVmean of at least 15% pre/post Zometa was taken as evidence of a “PET response”. Per the protocol, Scan 2 was used as the pre-Zometa measure of SUVmean, and Scan 3 (1-2 weeks later) was used as the post-Zometa measure of SUVmean.|Within 3 weeks|||Proportion of participants with response||90% Confidence Interval|Number
827988|NCT01205685|Secondary|Correlative Studies|Biomarkers associated with response to OSI-906 + Erlotinib + Letrozole + Goserelin|< or = to 2 weeks before initiation of Phase II study treatment period|No correlative studies were performed because the study did not move to the Phase II portion|||||
827989|NCT01205685|Secondary|Number of Participants With Tumor Response Per RECIST|Per RECIST criteria v. 1.1: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) > 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions|Every 12 weeks to tumor progression|Patients who were available for measurement of tumor response.||participants|||Number
827990|NCT01205685|Secondary|Safety Profile Based on Number of Patients With Each Worst-grade Toxicity|According to National Cancer Institute Common Toxicity Criteria for Adverse Events with 1 = mild, 2 = moderate, 3 = severe, 4 = life threatening/disabling, and 5 = death.|Every 4 weeks up to 24 weeks|Patients who received treatment and experienced an adverse event.||participants|||Number
827991|NCT01205685|Primary|Anti-tumor Activity of OSI-906|Time to progression measured in months from study entry to date of disease progression|From study entry to 6 months|Patients who received treatment and who were available for determination of disease progression. One patient withdrew after beginning of treatment and was not available for determination of the duration of disease progression.||months||Full Range|Median
827992|NCT01211145|Secondary|Use of Rescue Medication During the First 24 Hours After Treatment||24 hours post-treatment.|Full analysis set (observed cases)||Participants|||Number
827993|NCT01211145|Secondary|Sustained Headache Response at 2 Hours|Sustained headache response at 2 hours is a binary response variable derived from the headache intensities recorded in the patient diary. Sustained headache response is defined as a reduction in migraine headache pain intensity from severe or moderate to mild or none a 1 hr. which is then maintained (without a return to moderate or severe pain) at 2 hrs. with no use of rescue medication prior to the 2 hr. assessment.|Up to 2 hours post-treatment|Full analysis set (observed case)||Participants|||Number
827994|NCT01211145|Secondary|Headache Response at 24 Hours Post-treatment|Headache response is a binary response variable derived from the headache intensities recorded in the patient diary. Headache response is defined as a reduction in headache pain intensity from severe or moderate to mild or none with no use of rescue medication prior to the assessment.|24 hours post-treatment|Full analysis set (observed case)||Participants|||Number
827995|NCT01211145|Secondary|Headache Response at 2 Hours Post-treatment|Headache response is a binary response variable derived from the headache intensities recorded in the patient diary. Headache response is defined as a reduction in headache pain intensity from severe or moderate to mild or none with no use of rescue medication prior to the assessment.|2 hours post-treatment|Full analysis set (last observation carried forward)||Participants|||Number
827996|NCT01211145|Secondary|Pain-free Status at 24 Hours Post-treatment||24 hours post-treatment|Full analysis set (observed case)||Participants|||Number
827997|NCT01211145|Primary|Pain-free Status at 2 Hours Post-treatment||2 hours post-treatment.|Full analysis set (last observation carried forward)||Participants|||Number
827998|NCT01211184|Secondary|Muscle Catabolism|Assessed by the ratio of 3-methylhistidine/creatinine in excreted urine (unit: mmol/mmol).This is an amino acid unique to muscle that does not undergo intermediary metabolism, meaning that its urinary excretion is an index of the degree of muscle catabolism.|From the morning after surgery (07.30) up to the morning two days after sthe surgery (07.30)|Per protocol||mmol/mmol||Standard Deviation|Mean
827999|NCT01211184|Primary|Change in Insulin Sensitivity (Percent)|Insulin sensitivity (micro-mol per kg per minute glucose uptake) was calculated based on an intravenous glucose tolerance test (Theor Biol Med Model 2011, 8: 12) on the day before surgery. The percent change was taken as (day after - day before) / day before|Day before surgery (approximately 3 PM) and in the morning after surgery (approx. 7.30 AM).|Per protocol analysis. The study was powered to detect a difference in glucose clearance.||percent change of insulin sensitivity||Inter-Quartile Range|Median
828089|NCT01214252|Primary|Confirmed Hernia Recurrence|Confirmed hernia or hernia recurrence: Proportion of patients treated with Permacol Surgical Implant who experienced hernia or hernia recurrence at the repair site. Hernia or recurrence is defined by hernia diagnosis during clinical assessment by surgeon or medical chart review|12 months|||participants|||Number
828000|NCT01211197|Secondary|Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Blood Chemistry and Assessment of Tolerability by the Investigator.|Clinically relevant abnormalities for physical examination, vital signs, ECG, blood chemistry and assessment of tolerability by the investigator. New abnormal findings or worsening of baseline conditions were reported as adverse events.|Drug administration up to 7 days after last drug administration, up to 8 days|Treated set (TS) includes all subjects who took at least 1 dose of investigational medication and was used for safety analysis.||participants|||Number
828001|NCT01211197|Secondary|Apparent Volume of Distribution During the Terminal Phase (Vz/F)|"Apparent volume of distribution during the terminal phase (λz).
Note the standard deviation is actually the CV."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set included all evaluable subjects who took at least 1 dose of investigational medication, provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of pharmacokinetics.||Litres||Standard Deviation|Mean
828002|NCT01211197|Secondary|Apparent Clearance After Extravascular Administration (CL/F)|"Apparent clearance of the analyte in the plasma after extravascular administration.
Note the standard deviation is actually the CV."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set included all evaluable subjects who took at least 1 dose of investigational medication, provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of pharmacokinetics.||mL/min||Standard Deviation|Mean
828003|NCT01211197|Secondary|Mean Residence Time in the Body After Oral Administration (MRTpo)|"Mean residence time of the analyte in the body after oral administration.
Note the standard deviation is actually the CV."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set included all evaluable subjects who took at least 1 dose of investigational medication, provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of pharmacokinetics.||hours||Standard Deviation|Mean
828004|NCT01211197|Secondary|Terminal Half-life in Plasma (T1/2)|"Terminal half-life of the analyte in plasma.
Note the standard deviation is actually the CV."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set included all evaluable subjects who took at least 1 dose of investigational medication, provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of pharmacokinetics.||hours||Standard Deviation|Mean
828005|NCT01211197|Secondary|Terminal Elimination Rate Constant in Plasma (λz)|"Terminal elimination rate constant in plasma.
Note the standard deviation is actually the CV."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set included all evaluable subjects who took at least 1 dose of investigational medication, provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of pharmacokinetics.||1/h||Standard Deviation|Mean
828006|NCT01211197|Secondary|Time to Maximum Measured Concentration (Tmax)|"Time from dosing to the maximum concentration of the analyte in plasma.
Note the standard deviation is actually the CV."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set included all evaluable subjects who took at least 1 dose of investigational medication, provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of pharmacokinetics.||hours||Full Range|Median
828007|NCT01211197|Primary|Metformin: Maximum Measured Concentration (Cmax)|"Maximum measured concentration of metformin in plasma.
Note the standard deviation is actually the CV."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set included all evaluable subjects who took at least 1 dose of investigational medication, provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of pharmacokinetics.||ng/mL||Standard Deviation|Mean
828008|NCT01211197|Primary|Metformin: Area Under the Curve 0 to Infinity (AUC0-∞)|"Area under the concentration-time curve of metformin in plasma over the time interval from 0 extrapolated to infinity.
Note the standard deviation is actually the CV."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set included all evaluable subjects who took at least 1 dose of investigational medication, provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of pharmacokinetics.||ng*h/mL||Standard Deviation|Mean
828009|NCT01211197|Secondary|Metformin: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)|"Area under the concentration-time curve of metformin in plasma over the time interval from 0 to the time of the last quantifiable data point.
Note the standard deviation is actually the CV."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set included all evaluable subjects who took at least 1 dose of investigational medication, provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of pharmacokinetics.||ng*h/mL||Standard Deviation|Mean
828010|NCT01211197|Secondary|Empa: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)|"Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 to the time of the last quantifiable data point.
Note the standard deviation is actually the CV."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set included all evaluable subjects who took at least 1 dose of investigational medication, provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of pharmacokinetics.||nmol*h/L||Standard Deviation|Mean
828090|NCT01214330|Secondary|Patient Attitudes|Results from SoloPap Patient Questionairre regarding patient attitudes.|6 months||||||
828011|NCT01211197|Primary|Empa: Maximum Measured Concentration (Cmax)|"Maximum measured concentration of empagliflozin (empa) in plasma.
Note the standard deviation is actually the CV."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set included all evaluable subjects who took at least 1 dose of investigational medication, provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of pharmacokinetics.||nmol/L||Standard Deviation|Mean
828012|NCT01211197|Primary|Empa: Area Under the Curve 0 to Infinity (AUC0-∞)|"Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity.
Note the standard deviation is actually the coefficient of variation (CV)."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set included all evaluable subjects who took at least 1 dose of investigational medication, provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of pharmacokinetics.||nmol*h/L||Standard Deviation|Mean
828013|NCT01211340|Secondary|Anxiety|This measure determines the level of anxiety experienced by a hospice caregiver. Total scores range from 0-21 with higher scores representing more anxiety. Only the last available measure will be used to reflect the measure closest to time of death.|Every 14 days until the death of the patient for an average of 45 days-Only measure used in analysis is the last completed measure|||units on a scale||Standard Deviation|Mean
828014|NCT01211340|Secondary|Caregiver Quality of Life-Revised Subscale Emotional|This is one domain of a four domain instrument. It involves one question with a range of 0-10.Only the last available measure will be used to reflect the measure closest to time of death.|Every 14 days until the death of the patient for an average of 45 days-Only measure used in analysis is the last completed measure|||units on a scale||Standard Deviation|Mean
828015|NCT01211340|Primary|Caregiver Perceptions of Pain Medicine Questionaire|This 16 question instrument measures the perceptions hospice caregivers have toward the administration of pain medications. Scores on items vary from 1-5 with the lower scores indicating more problematic perceptions of pain management. A Total score is computed between 16-80 Only the last available measure will be used to reflect the measure closest to time of death.|Every 14 days until the death of the patient for an average of 45 days-Only measure used in analysis is the last completed measure|||units on a scale||Standard Deviation|Mean
828016|NCT01213576|Secondary|Number of Participants With Microfilarial Clearance at 24 Months of Follow up|Microfilaria will be detected using the nucleopore filtration technique and analysed according to the respective treatment arms at the 24 month time point. Microfilarial clearance will be defined by non-detection of microfilaria in the night blood sample|24 months|Intention to treat, with last result carried forward in the case of missing visit||participants|||Number
828017|NCT01213576|Primary|Number of Participants Achieving Microfilarial Clearance|Microfilaria clearance will be assessed in regard to dosage as well as frequency of treatment. Microfilarial clearance is defined by non-detection of microfilaria in the night blood sample.|12 months|Number of participants with non detectable microfilaria at follow up||participants|||Number
828018|NCT01213589|Secondary|Clinical Success|"Clinical success was defined as: (i) successful introduction and deployment of the Valiant Thoracic Stent Graft at the intended location; (ii) successful coverage of the proximal entry tear; (iii) no immediate conversion to open surgery;(iv) absence of surgical open repair or endovascular re-intervention; (v) absence of death related to aortic disease or treatment; (vi) absence of graft thrombosis, obstructions, twists or kinks; (vii) absence of graft migration;(viii) absence of graft integrity failure; (ix) at the level of the ostium of the LSA, the more proximal entry tear of the dissection, the largest section of the thoracic aorta, and at the first image/slice available with upper part of the liver:
Absence of true lumen decrease in diameter (≥ 5 mm is significant) Absence of increase in total aortic diameter (≥ 5 mm is significant)"|through 36 months|||participants|||Number
828019|NCT01213589|Secondary|Freedom From Disease-, Procedure-, or Device-related Severe Complications|"Complications were assigned a severity score (according SVS scores) so that degrees of morbidity can be assessed and compared. A severe complication necessitates major surgical or medical intervention, may be associated with prolonged convalescence, is usually accompanied by prolonged or permanent disability, and may result in death.
Kaplan-Meier estimate of freedom from disease-, procedure-, or device-related severe complications"|through 36 months|||Percentage Event Free|||Number
828020|NCT01213589|Secondary|Freedom From Disease-, Procedure- or Device-related Major Complications|"Complications were assigned a severity score (according SVS scores) so that degrees of morbidity can be assessed and compared. A moderate complication indicates the need for significant intervention, prolongation of hospitalization more than 24 hours, and at most, minor permanent disability that does not preclude normal daily activity. A severe complication necessitates major surgical or medical intervention, may be associated with prolonged convalescence, is usually accompanied by prolonged or permanent disability, and may result in death. Both moderate and severe complications are considered as major complications.
Kaplan-Meier estimate of freedom from disease-, procedure-, or device-related major complications by clinical group."|through 36 months|||Percentage Event Free|||Number
828021|NCT01213589|Secondary|Freedom of Re-intervention|Kaplan-Meier estimate of freedom from secondary procedures by clinical group.|30 days or at discharge, 3/6/12/24/36 months|||Percentage Event Free|||Number
828022|NCT01213589|Secondary|Efficacy/Performance|- Technical Success Technical success, defined as a composite of (i) successful introduction and deployment of at least one Valiant Thoracic Stent Graft at the intended location, (ii) successful coverage of the proximal entry tear, (iii) no immediate conversion to open surgery during the same intervention, (iv) absence of death within 24 hours post-procedure, and (v) the absence of significant graft twist, kink or obstruction by intra-operative measurements|30 days or at discharge, 3/6/12/24/36 months|||participants|||Number
828023|NCT01213589|Secondary|Safety|"All causes mortality
Disease-, procedure- or device-related mortality"|30 days or at discharge, 3/6/12/24/36 months|||participants|||Number
828024|NCT01213589|Primary|Disease-, Procedure- or Device-related Mortality at 12 Months Post-procedure|Disease, device or procedure-related mortality at 12 months post-procedure, defined as any death related to the device, to the disease or to the surgical procedure occurring in the period of 365 days following the day of the implant procedure.|12 months post-procedure|||participants|||Number
828026|NCT01213823|Primary|Number of Any Severe Hepatic Injury Cases and Matched Controls|Severe hepatic injury (acute/subacute necrosis of liver, hepatic coma, hepatorenal syndrome, or hepatitis unspecified) classified as: 1) acute liver failure (associated with encephalopathy and/or coagulopathy in absence of underlying liver disease); 2) Hy's Law Criteria (serum alanine transaminase [ALT] levels greater than [>]3 times the upper limit of normal [ULN] and direct bilirubin >2 times ULN and absence of alkaline phosphatase elevation); 3) ALT levels greater than or equal to (≥) 10 times ULN; 4) ALT levels >3 times ULN and less than (<) 10 times ULN; or 5) classified by clinician. Disease Related Group (DRG) severity of illness coding was reported for severe hepatic injury cases and matched controls.|01 June 2006 to 30 June 2008 (up to 25 Months)|Acute-care participants, with at least 1 dose of echinocandin antifungal therapy and a primary or secondary International Classification of Diseases 9 (ICD-9).||Participants|||Number
828027|NCT01213836|Secondary|Mean Ratio of Morning Plasma Concentration of Quetiapine and Nor-quetiapine for Quetiapine IR and Quetiapine XR, at Steady-state Conditions in the End of Each Treatment Period 1 and 2.|The ratio was derived as individual plasma concentration of quetiapine divided by the plasma concentration of nor-quetiapine. The mean ratio was derived for each treatment, XR and IR, respectively.|End of Period 1, end of Period 2|21 patients for the FAS were analysed. This outcome measure was introduced as a protocol amendment after study start and plasma concentration was not measured in all patients. FAS is all patients who, in both study periods, received at least one dose of investigational product and for whom post-dose efficacy data are available in both periods.||Ratio||Standard Deviation|Mean
828028|NCT01213836|Secondary|Number of Dropouts.|The number of patients who dropped out was counted.|Period 1 and Period 2|The Safety analysis set was used, that is all patients who received at least one dose of study medication and for whom any post-dose safety data are available were included in the safety set.||participants|||Number
828029|NCT01213836|Secondary|Mean Overall Sedation as Measured by the Stanford Sleepiness Scale When Administered According to Label|"Stanford Sleepiness Scale: The sleepiness was assessed by the patient on a 7 item rating scale ranging from 1 (Feeling active and vital) to 7 (Almost in reverie).
There are 3 assessments made in each period (post 1, 2 and 3 for each period). That is three measurements per patient per treatment. The mean is an overall mean of all the recordings in all patients, one mean value per treatment group."|Period 1 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. Period 2 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period.|The full analysis set (FAS) used for analysis of efficacy included all patients who, in both study periods, received at least one dose of investigational product and for whom post-dose efficacy data are available in both periods.||units on a scale||Standard Deviation|Mean
828030|NCT01213836|Secondary|Mean Overall Sedation as Measured by the Modified Bond-Lader Visual Analogue Scale (VAS) When Administered According to Label|"The modified Bond-Lader VAS: The degree of sedation was marked by the patient on a 100 mm VAS ranging between Alert (=0 mm) and Drowsy (=100 mm). The marked length in millimetres.
There are 3 assessments made in each period (post 1, 2 and 3 for each period). That is three measurements per patient per treatment. The mean is an overall mean of all the recordings in all patients, one mean value per treatment group."|Period 1 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. Period 2 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period.|The full analysis set (FAS) used for analysis of efficacy included all patients who, in both study periods, received at least one dose of investigational product and for whom post-dose efficacy data are available in both periods.||units on a scale||Standard Deviation|Mean
828031|NCT01213836|Secondary|Mean Daytime Cognitive Performance Using CogState: - Working Memory - Verbal Learning) -Reasoning and Problem Solving|International Shopping List Task (ISLT): measures reasoning and problem solving. Min=minus infinity, max=plus infinity, higher score=better performance. Groton Maze Learning Test (GMLT): measures reasoning and problem solving. Min=minus infinity, max=plus infinity, lower score=better performance. Lower=better performance. One Back memory task (ONB: measures working memory, min=minus infinity, max=plus infinity, lower score=better performance.|Period 1 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. Period 2 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period.|Per Protocol (PPS), subset of the FAS consisting of patients who fulfilled all of inclusion but none of exclusion criteria, complied with study medication dosing, did not violate any of the restrictions and completed the study without protocol violation.||Units on a scale||Standard Deviation|Mean
828032|NCT01213836|Secondary|Mean Treatment Satisfaction for Treatment Satisfaction Questionnaire of Medication (TSQM)|"TSQM is a 14-item questionnaire with 4 sub-scales: effectiveness of the medication; treatment side effects; convenience of the medication; global satisfaction with the medication. Scale range 0-100 for each sub-scale, higher=greater satisfaction/milder side effects/greater convenience/greater overall satisfaction.
There are 2 measurement, (after the start of taking study drug) one at end of period 1 and one at end of period 2. That is one measurement per patient per treatment. The mean of all the patients is presented, one mean value per treatment group."|Before taking study drug, end of Period 1 and end of Period 2|Full Analysis Set (FAS)used for efficacy analysis included all patients who in both study periods, received at least 1 dose of investigational product and for whom post-dose efficacy data was available.||units on a scale||Standard Deviation|Mean
828033|NCT01213836|Primary|Mean for Attentional Standardised Composite Score Based on Performance Scores From the CogState Test Battery Domains Detection (Speed of Processing)and Identification (Attention/Vigilance)|Attentional standardised composite score: Standardised speed of performance score. Higher Score=better performance. Score range minus infinity to plus infinity. Measured at baseline (before study drug administration) and in Period 1 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. (Last test day not earlier than after 10 days of randomised)and in Period 2 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. Last test day not earlier than after 10 days of crossover treatment.|Period 1 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. Period 2 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period.|The per protocol set (PPS) is a subset of the FAS consisting of patients who fulfilled all inclusion criteria but none of the exclusion criteria, complied with study medication dosing scheme, did not violate any of the study restrictions and completed the study without protocol violation.||standardised units||Standard Deviation|Mean
828289|NCT01215695|Secondary|Laryngeal View Grade of 1 or 2|The laryngeal view as Grade 1 (full view of the glottis) or Grade 2 (glottis partly exposed, anterior commissure not seen) according to the method described by Cormack and Lehane (1984).|30 minutes|||Participants|||Count of Participants
828034|NCT01213966|Primary|Derived Parasite Reduction Rate at 24 Hours (PPR24)|"PRR24 is the log10 change in parasitemia over 24 hours estimated from a regression model fit separately for each patient. The relationship between parasite counts and time was analyzed by fitting a variable lag phase, then a linear decline to the natural log of parasite count versus time relationship. The slope of this log linear relationship is the primary end-point.
The time points chosen for the regression are those that yield the highest degree of significance when assessing the regression when the number of time points are greater than or equal to 3. No extrapolation was performed."|24 hours after study drug administration|||Log10 parasites/24h||Full Range|Median
828035|NCT01214083|Secondary|Liver Function Tests (ALT)||week 0 and week 13|||units/liter||Standard Error|Mean
828036|NCT01214083|Secondary|Drinks Per Drinking Days||week 1 and week 13|||drinks/drinking day||Standard Error|Mean
828037|NCT01214083|Secondary|Percentage of Drinking Days|"Percentage of drinking days was measured by the Time Line Follow Back (TLFB) Method. The percentage has a total range of 0%-100%. Higher percentages represent a worse outcome (i.e., more drinking days)."|week 1 and week 13|||percentage of drinking days||Standard Error|Mean
828038|NCT01214083|Secondary|Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)|The Quality of Life Enjoyment and Satisfaction Questionnaire is designed to assess a quality of life. The scale has a total score range of 16-80. Higher values represent a better outcome (i.e., better quality of life).|week 1 and week 13|||units on a scale||Standard Error|Mean
828039|NCT01214083|Secondary|Clinical Global Impression (CGI)|The Clinical Global Impression is designed to assess overall severity of illness. The scale has a total score range of 1-7. Higher values represent a worse outcome (i.e., severe illness).|week 1 and week 13|||units on a scale||Standard Error|Mean
828040|NCT01214083|Secondary|Obsessive Compulsive Drinking Scale (OCDS)|The Obsessive Compulsive Drinking Scale is designed to assess obsessive and compulsive aspects of alcoholism. The scale has a total score range of 0-56. Higher values represent a worse outcome (i.e., more alcohol problems).|week 1 and week 13|||units on a scale||Standard Error|Mean
828041|NCT01214083|Secondary|Penn Alcohol Craving Scale (PACS)|The Penn Alcohol Craving Scale is designed to assess alcohol craving severity. The scale has a total score range of 0-30. Higher values represent a worse outcome (i.e., higher craving).|week 1 and week 13|||units on a scale||Standard Error|Mean
828042|NCT01214083|Secondary|Liver Function Tests (AST)||week 0 and week 13|||units/liter||Standard Error|Mean
828043|NCT01214083|Primary|Percentage of Heavy Drinking Days|"Percentage of heavy drinking days was measured by the Time Line Follow Back (TLFB) Method. ('Heavy drinking' was defined as 5 or more standard drinks per day for men and 4 or more standard drinks for women.) The percentage has a total range of 0%-100%. Higher percentages represent a worse outcome (i.e., more heavy drinking)."|week 1 and week 13|||percentage of heavy drinking days||Standard Error|Mean
828044|NCT01214109|Secondary|Apparent Volume of Distribution During the Terminal Phase at Steady State Following Oral Administration (Vz/F,ss) for PK Population (Excluding Subjects Due to Emesis)|Vz/F,ss = Apparent volume of distribution during the terminal phase λz at steady state following oral administration|27 days|PK Population excluding subjects with reported emesis - Subjects with values for Vz/F,ss excluding subjects with reported emesis||L||Geometric Coefficient of Variation|Geometric Mean
828045|NCT01214109|Secondary|Apparent Volume of Distribution During the Terminal Phase at Steady State Following Oral Administration (Vz/F,ss) for PK Population (All Subjects)|Vz/F,ss = Apparent volume of distribution during the terminal phase λz at steady state following oral administration|27 days|PK Population - Subjects with values for Vz/F,ss||L||Geometric Coefficient of Variation|Geometric Mean
828046|NCT01214109|Secondary|The Apparent Clearance of the Analyte in Plasma at Steady State Following Oral Administration (CL/F,ss) for PK Population (Excluding Subjects Due to Emesis)|CL/F,ss = Apparent clearance of the analyte in the plasma at steady state following oral administration|27 days|PK Population excluding subjects with reported emesis - Subjects with values for CL/F,ss excluding subjects with reported emesis||mL/min||Geometric Coefficient of Variation|Geometric Mean
828047|NCT01214109|Secondary|The Apparent Clearance of the Analyte in Plasma at Steady State Following Oral Administration (CL/F,ss) for PK Population (All Subjects)|CL/F,ss = Apparent clearance of the analyte in the plasma at steady state following oral administration|27 days|PK Population - Subjects with values for CL/F,ss||mL/min||Geometric Coefficient of Variation|Geometric Mean
828048|NCT01214109|Secondary|Minimum Steady State Concentration (Cmin,ss) for PK Population (Excluding Subjects Due to Emesis)|Cmin,ss = Minimum observed concentration of the analyte in plasma at steady state|27 days|PK Population excluding subjects with reported emesis - Subjects with values for Cmin,ss excluding subjects with reported emesis||ng/mL||Geometric Coefficient of Variation|Geometric Mean
828049|NCT01214109|Secondary|Minimum Steady State Concentration (Cmin,ss) for PK Population (All Subjects)|Cmin,ss = Minimum observed concentration of the analyte in plasma at steady state|27 days|PK Population - Subjects with values for Cmin,ss||ng/mL||Geometric Coefficient of Variation|Geometric Mean
828050|NCT01214109|Secondary|Terminal Half-life of the Analyte in Plasma at Steady State (t1/2,ss) for PK Population (Excluding Subjects Due to Emesis)|t1/2,ss - Apparent plasma terminal elimination half-life at steady state|27 days|PK Population excluding subjects with reported emesis - Subjects with values for t1/2,ss excluding subjects with reported emesis||h||Geometric Coefficient of Variation|Geometric Mean
828051|NCT01214109|Secondary|Terminal Half-life of the Analyte in Plasma at Steady State (t1/2,ss) for PK Population (All Subjects)|t1/2,ss - Apparent plasma terminal elimination half-life at steady state|27 days|PK Population - Subjects with values for t1/2,ss||h||Geometric Coefficient of Variation|Geometric Mean
828052|NCT01214109|Secondary|Average Concentration in Plasma Under Steady-state Conditions (Cavg) for PK Population (Excluding Subjects Due to Emesis)|Cavg = Average concentration of the analyte in plasma at steady state|27 days|PK Population excluding subjects with reported emesis - Subjects with values for Cavg excluding subjects with reported emesis||ng/mL||Geometric Coefficient of Variation|Geometric Mean
828053|NCT01214109|Secondary|Average Concentration in Plasma Under Steady-state Conditions (Cavg) for PK Population (All Subjects)|Cavg = Average concentration of the analyte in plasma at steady state|27 days|PK Population - Subjects with values for Cavg||ng/mL||Geometric Coefficient of Variation|Geometric Mean
830148|NCT01227629|Secondary|Thromboembolic Events: Number of Participants With Transient Ischemic Attack|Occurence of a transient ischemic attack|12 weeks|All randomized patients. No statistical comparisons were performed, due to the extremely small number of events.||Participants|||Number
828054|NCT01214109|Secondary|Predose Steady State Concentration of the Analyte Immediately Before Administration of the Next Drug Administration (Cpre,ss) for PK Population (Excluding Subjects Due to Emesis)|Cpre,ss = pre-dose concentration of the analyte in plasma at steady state immediately before administration of the next dose|27 days|PK population excluding subjects with reported emesis - Subjects with values for Cpre,ss excluding subjects with reported emesis||ng/mL||Geometric Coefficient of Variation|Geometric Mean
828055|NCT01214109|Secondary|Predose Steady State Concentration of the Analyte Immediately Before Administration of the Next Drug Administration (Cpre,ss) for PK Population (All Subjects)|Cpre,ss = pre-dose concentration of the analyte in plasma at steady state immediately before administration of the next dose|27 days|PK population - Subjects with values for Cpre,ss||ng/mL||Geometric Coefficient of Variation|Geometric Mean
828056|NCT01214109|Secondary|Peak-to-trough Fluctuation (PTF) for PK Population (Excluding Subjects Due to Emesis)|PTF = Peak-to-trough fluctuation is measured as a percent|27 days|PK population excluding subjects with reported emesis - Subjects with values for PTF excluding subjects with reported emesis||percent||Geometric Coefficient of Variation|Geometric Mean
828057|NCT01214109|Secondary|Peak-to-trough Fluctuation (PTF) for PK Population (All Subjects)|PTF = Peak-to-trough fluctuation is measured as a percent|27 days|PK population - Subjects with values for PTF||percent||Geometric Coefficient of Variation|Geometric Mean
828058|NCT01214109|Secondary|Time From Dosing to the Maximum Measured Concentration of the Analyte in Plasma (Tmax) for PK Population (Excluding Subjects Due to Emesis)|tmax = time of maximum observed plasma concentration|27 days|PK population excluding subjects with reported emesis - Subjects with values for t_max excluding subjects with reported emesis||hours||Full Range|Median
828059|NCT01214109|Secondary|Time From Dosing to the Maximum Measured Concentration of the Analyte in Plasma (Tmax) for PK Population (All Subjects)|tmax = time of maximum observed plasma concentration|27 days|PK population - Subjects with values for tmax||hours||Full Range|Median
828060|NCT01214109|Primary|Maximum Steady State Concentration (Cmax,ss) for PK Population (Excluding Subjects Due to Emesis)|Cmax,ss = maximum observed concentration of the analyte in plasma at steady state|27 days|PK population excluding subjects with reported emesis - Subjects with values for Cmax,ss excluding subjects with reported emesis||ng/mL||Geometric Coefficient of Variation|Geometric Mean
828061|NCT01214109|Primary|Maximum Steady State Concentration (Cmax,ss) for PK Population (All Subjects)|Cmax = maximum observed concentration of the analyte in plasma at steady state|27 days|PK population - Subjects with values for Cmax,ss||ng/mL||Geometric Coefficient of Variation|Geometric Mean
828062|NCT01214109|Primary|Area Under the Concentration-time Curve of Pramipexole in Plasma at Steady State Over 24 Hours (AUC0-24,ss); in Case of ER up to the Time Point of Next Dosing (AUCtau,ss) for PK Population (Excluding Subjects Due to Emesis)|AUC0-24,ss = area under the plasma concentration-time curve between 0 and 24 hours at steady state. AUCtau,ss = area under the plasma concentration-time curve over a dosing interval at steady state|27 days|PK population excluding subjects with reported emesis - Subjects with values for AUC0-24,ss for IR and values for AUCtau,ss for ER, excluding subjects with reported emesis||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
828063|NCT01214109|Primary|Area Under the Concentration-time Curve of Pramipexole in Plasma at Steady State Over 24 Hours (AUC0-24,ss); in Case of ER up to the Time Point of Next Dosing (AUCtau,ss) for Pharmacokinetic (PK) Population (All Subjects)|AUC0-24,ss = area under the plasma concentration-time curve between 0 and 24 hours at steady state. AUCtau,ss = area under the plasma concentration-time curve over a dosing interval at steady state|27 days|PK population - Subjects with values for AUC0-24,ss for IR and values for AUCtau,ss for ER||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
828064|NCT01214161|Secondary|Provider's Assessment of Patient's Maximum Pain on a Visual Analogue Scale|This secondary analysis looked at provider perception of patient maximum pain during IUD insertion This was not done per intervention because we were looking at the accuracy of the provider's assesment of the patient's pain, which is not dependent on intervention. The provider was blinded to the intervention so that would not have influenced results.|during IUD insertion|||units on a 100 mm visual analogue scale||Standard Deviation|Mean
828065|NCT01214161|Secondary|Adverse Events||During IUD insertion|||participants|||Number
828066|NCT01214161|Primary|Pain During IUD Insertion at Various Time Points (See Description for Time Points)|Patient marked pain on a 100 mm visual analogue scale during the part of the IUD insertion procedure where the tenaculum was placed, the uterus was measured/sounded, the IUD was inserted into the uterus, and the speculum was removed.|During IUD insertion (see above description for which time points)|||units on a 100 mm visual analogue scale||Standard Deviation|Mean
828067|NCT01214174|Primary|Proportion of Patients With Anterior Chamber Cell Clearing at Day 8 Post-Treatment|This study will measure as its primary endpoint the anterior chamber cell count at Day 8 post-treatment in the study eye. The proportion of patients with anterior chamber cell count = 0 at Day 8 in the study eye for each dosage group will be compared. Only one eye was treated per participant.|8 days post-treatment|||percentage of patients with ACC clearing||95% Confidence Interval|Number
828068|NCT01214187|Secondary|St George's Respiratory Questionnaire|St. George's Respiratory Questionnaire (SGRQ) is a validated self-reported instrument. In this instrument, scores range from 0 to 100, with higher scores reflective of worse quality of life.|Baseline to Week 12|||Total Score||Standard Error|Least Squares Mean
828069|NCT01214187|Secondary|Six Minute Walk Distance|The six minute walk distance is commonly used both in research studies and in clinical practice as a measure of functional capabilities, and changes in six minute walk distance and oxygen use during testing over time often reflect clinically relevant disease progression. We will measure the distance travelled during six minutes (meters) in accordance with published guidelines|Baseline to Week 12|||meters||Standard Error|Least Squares Mean
828070|NCT01214187|Secondary|Diffusing Capacity for Carbon Monoxide (DLCO) % Predicted Values|Interstitial changes associated with IPF can worsen diffusing capabilities across the alveolar-capillary membrane. As a result, diffusing capacity of carbon monoxide is an important outcome to assess architectural distortion and resultant decrements in diffusing capabilities|Baseline to Week 12|||% predicted||Standard Error|Least Squares Mean
828071|NCT01214187|Secondary|Total Lung Capacity % Predicted Values (TLC)|Total lung capacity % predicted values (TLC) is a major clinical determinant of restrictive lung disease in practice, with TLC measurement below the 5th percentile of the predicted value indicative of a restrictive ventilatory defect|Baseline to Week 12|||% Predicted||Standard Error|Least Squares Mean
828072|NCT01214187|Primary|Serum MMP7 Level|The primary study endpoint was the change in MMP7 serum concentration (ng/ml) from baseline to 12 weeks. Serum MMP7 concentrations in peripheral blood are easily measureable and reflect changes in the alveolar microenvironment. Thus, we have chosen to study mean serum MMP7 concentrations after three months of CO treatment as a surrogate biomarker of the effect of inhaled CO administration on disease progression.|Baseline to Week 12|One subject randomized to placebo withdrew consent prior to the MMP7 blood draw at visit 2. This is missing data and the reason why we have n=28 for placebo group.||ng/ml||Standard Error|Least Squares Mean
828073|NCT01214239|Secondary|Number With HbA1c at Least Lowering 0.5%|Number with HbA1c at least 0.5% lowering from baseline at week 24|baseline and at week 24|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Non-completers were considered as failure imputation (NCF).||Patients|||Number
828074|NCT01214239|Secondary|Number of Patients With HbA1c < 6.5% at Week 24 With Baseline HbA1c >= 6.5%.|Number of patients with HbA1c < 6.5% at week 24 with baseline HbA1c >= 6.5%.|baseline and at week 24|This population includes the FAS with baseline HbA1c >= 6.5%. Non-completers were considered as failure imputation (NCF).||Patients|||Number
828075|NCT01214239|Secondary|Number of Patients With HbA1c < 6.5%|Number of patients with HbA1c < 6.5% at week 24|baseline and at week 24|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Non-completers were considered as failure imputation (NCF).||Patients|||Number
828076|NCT01214239|Secondary|Number of Patients With HbA1c < 7.0% at Week 24 With Baseline HbA1c >= 7.0%.|Number of patients with HbA1c < 7.0% at week 24 with baseline HbA1c >= 7.0%.|baseline and at week 24|This population includes the FAS with baseline HbA1c >= 7.0%. Non-completers were considered as failure imputation (NCF).||Patients|||Number
828077|NCT01214239|Secondary|Number of Patients With HbA1c < 7.0%|Number of patients with HbA1c < 7.0% at week 24|baseline and at week 24|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Non-completers were considered as failure imputation (NCF).||Patients|||Number
828078|NCT01214239|Secondary|FPG Change From Baseline at Week 24|Means are treatment adjusted for baseline FPG and previous anti-diabetic medication.|Baseline and at week 24|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||mg/dL||Standard Error|Least Squares Mean
828079|NCT01214239|Secondary|FPG Change From Baseline at Week 18|Means are treatment adjusted for baseline FPG and previous anti-diabetic medication.|Baseline and at week 18|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||mg/dL||Standard Error|Least Squares Mean
828080|NCT01214239|Secondary|FPG Change From Baseline at Week 12|Means are treatment adjusted for baseline FPG and previous anti-diabetic medication.|Baseline and at week 12|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||mg/dL||Standard Error|Least Squares Mean
828081|NCT01214239|Secondary|FPG Change From Baseline at Week 6|Means are treatment adjusted for baseline fasting plasma glucose (FPG) and previous anti-diabetic medication.|Baseline and at week 6|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||mg/dL||Standard Error|Least Squares Mean
828082|NCT01214239|Secondary|HbA1c Change From Baseline at Week 24 in the Subset of Chinese Patients|Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and at week 24|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available (in the subset of Chinese patients). Last observation carried forward (LOCF) was used as the imputation rule.||% of HbA1c||Standard Error|Least Squares Mean
828083|NCT01214239|Secondary|HbA1c Change From Baseline at Week 18|Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and at week 18|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||% of HbA1c||Standard Error|Least Squares Mean
828084|NCT01214239|Secondary|HbA1c Change From Baseline at Week 12|Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and at week 12|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||% of HbA1c||Standard Error|Least Squares Mean
828085|NCT01214239|Secondary|HbA1c Change From Baseline at Week 6|Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and at week 6|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||% of HbA1c||Standard Error|Least Squares Mean
828086|NCT01214239|Primary|HbA1c Change From Baseline at Week 24|Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and at week 24|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||% of HbA1c||Standard Error|Least Squares Mean
828087|NCT01214252|Secondary|Hernia or Hernia Recurrence by Year From Year 2 to Last Year Observed|Confirmed and Unconfirmed hernia or hernia recurrence by year from Year 2 to last year observed|Year 2 to Year 8|||participants|||Number
828088|NCT01214252|Secondary|Total Unconfirmed Hernia or Hernia Recurrence|"Total unconfirmed hernia or hernia recurrence at the repair site by year (Number and percentage)
Unconfirmed hernia or recurrence reported by the subject is defined by confirmation of hernia symptoms based on results of the Symptoms Questionniare but not confirmed by clinical assessment by a surgeon or medical chart review"|12 Months|||participants|||Number
828091|NCT01214330|Primary|Concordance (Similarity Between Samples) of Pap Smears|Is the SoloPap collection device as good at detecting cervical dysplasia as a clinician-collected Pap Smear?|1 year|102 females recruited from an outpatient clinic in a military treatment facility, age >18, without severe hand arthritis||percentage of participants|||Number
828093|NCT01214395|Primary|Primary Endpoint Will be the Number of Tea Tree Oil Patients That Did Not Have a Catheter-related Infection Within 6 Months After Entry Into the Trial.|"Catheter-related infections will be defined according to standard guidelines
Cases with definite and probable infections will be classified as infections."|6 months|||participants|||Number
828094|NCT01214434|Secondary|Percent Reduction From Baseline for Oiliness at End of Treatment.|Oiliness scored on a scale of 0 (none) to 4 (severe).|From Baseline to end of treatment (Day 7 or 14)|All subjects will data after baseline were included in the analysis. For the Bland emollient group, 2 subjects were excluded from the analysis. For the Promiseb group, 3 subjects were excluded and one of the subjects that did not complete the study was included with Day 7 data carried forward to impute missing Day 14 data.||percent reduction from baseline||Standard Deviation|Mean
828095|NCT01214434|Secondary|Percent Reduction From Baseline for Erythema at End of Treatment.|Erythema scored on scale of 0 (none) to 4 (severe).|From Baseline to end of treatment (Day 7 or 14)|All subjects will data after baseline were included in the analysis. For the Bland emollient group, 2 subjects were excluded from the analysis. For the Promiseb group, 3 subjects were excluded and one of the subjects that did not complete the study was included with Day 7 data carried forward to impute missing Day 14 data.||percent reduction from baseline||Standard Deviation|Mean
828096|NCT01214434|Secondary|Percent Reduction From Baseline for Crusting at End of Treatment.|Crusting scored on a scale of 0 (none) to 4 (severe).|From Baseline to end of treatment (Day 7 or 14)|All subjects will data after baseline were included in the analysis. For the Bland emollient group, 2 subjects were excluded from the analysis. For the Promiseb group, 3 subjects were excluded and one of the subjects that did not complete the study was included with Day 7 data carried forward to impute missing Day 14 data.||percent reduction from baseline||Standard Deviation|Mean
828097|NCT01214434|Secondary|Precent Reduction From Baseline for Scaling at End of Treatment.|Scaling score on a scale of 0 (none) to 4 (severe).|From Baseline to end of treatment (Day 7 or 14)|All subjects will data after baseline were included in the analysis. For the Bland emollient group, 2 subjects were excluded from the analysis. For the Promiseb group, 3 subjects were excluded and one of the subjects that did not complete the study was included with Day 7 data carried forward to impute missing Day 14 data.||percent reduction from baseline||Standard Deviation|Mean
828098|NCT01214434|Primary|Number of Participants With Excellent Overall Safety Score at End of Treatment.|The investigator will assess tolerance at Day 7 and Day 14 using an overall safety score of 0 to 3 defined as; Grade 0-No signs of irritation (excellent); Grade 1-Slight signs of irritation which resolved (Good); Grade 2-Clear signs of irritation (Fair); Grade 3-Patient discontinued due to irritation(Poor).|End of treatment|All subjects will data after baseline were included in the analysis. For the Bland emollient group, 2 subjects were excluded from the analysis. For the Promiseb group, 3 subjects were excluded and one of the subjects that did not complete the study was included with Day 7 data carried forward to impute missing Day 14 data.||participants|||Number
828099|NCT01214434|Primary|Subjects With Investigator Global Assessment (IGA) Success (IGA of 0 or 1) at End of Treatment (Day 7 or 14).|IGA scored on scale of 0 (clear) to 4 (severe).|end of treatment (Day 7 or 14)|All subjects will data after baseline were included in the analysis. For the Bland emollient group, 2 subjects were excluded from the analysis. For the Promiseb group, 3 subjects were excluded and one of the subjects that did not complete the study was included with Day 7 data carried forward to impute missing Day 14 data.||percentage of participants|||Number
828100|NCT01214616|Primary|Drug-related Adverse Events|Number of patients with drug-related adverse events|during the treatment period or up to 28 days after the completion of drug administration, up to 730 days|Treated set||participants|||Number
828101|NCT01214616|Secondary|Objective Tumour Response|"According to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria and assessed by CT or MRI: Complete Response (CR), disappearance of all target and non-target lesions; Partial Response (PR), at least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|Pre-treatment, every 8 weeks after start of study treatment, end of treatment|Treated set||participants|||Number
828102|NCT01214616|Secondary|Cmax for Vinorelbine|maximum measured blood concentration|predose, 10minutes, 0.5, 1, 4, 7 hours, 23hours55minutes after 2nd or 3rd or 4th dose (as “with afatinib”) and 1st dose (as “without afatinib”)|Treated set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
828103|NCT01214616|Secondary|AUC0-∞ for Vinorelbine|area under the blood concentration-time curve of the analyte over the time interval from 0 extrapolated to infinity|predose, 10minutes, 0.5, 1, 4, 7 hours, 23hours55minutes after 2nd or 3rd or 4th dose (as “with afatinib”) and 1st dose (as “without afatinib”)|Treated set||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
828104|NCT01214616|Secondary|Cmax,ss for Afatinib|maximum measured plasma concentration at steady state|pre-dose, 1, 2, 3, 4, 6, 7hours, and 23hours55minutes after 7th or 14th or 21th dose (as “with Vinorelbine”) and 20th dose (as “without Vinorelbine”)|Treated set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
828105|NCT01214616|Secondary|AUCτ,ss for Afatinib|area under the plasma concentration-time curve following dose at steady state over the dosing interval τ|pre-dose, 1, 2, 3, 4, 6, 7hours, and 23hours55minutes after 7th or 14th or 21th dose (as “with Vinorelbine”) and 20th dose (as “without Vinorelbine”)|Treated set||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
828106|NCT01214616|Primary|Number of Patients With Dose Limiting Toxicities (DLTs) During 1st Course|DLTs and Maximum Tolerated Dose (MTD) of afatinib in combination with vinorelbine iv. (MTD = not determined)|during 1st course|Treated set: all patients who received at least 1 dose of investigational medication (afatinib or vinorelbine)||participants|||Number
828107|NCT01214720|Secondary|Bevacizumab Concentration in the Presence of Gemcitabine and Erlotinib|Blood samples were collected from a subgroup of participants, in selected centers for the determination of bevacizumab serum concentration before the first bevacizumab/placebo exposure (Week 1) and at Weeks 3, 5, 7, and 9. Each time blood samples were collected just (preferably within 1 hour) before the start of the study treatment.|Weeks 1, 3, 5, 7, and 9|ITT Population. Number (n) = number of participants assessed at a specific visit.||micrograms/milliliter||Standard Deviation|Geometric Mean
828108|NCT01214720|Primary|Duration of Overall Survival - Time to Event|Duration of OS was defined as the time between date of randomization and date of death due to any cause. Participants without an event were censored at the date last known to be alive. Participants who were randomized but not exposed to study drug and had no further follow up were censored at the date of randomization. Median duration of survival was estimated using the Kaplan-Meier method.|Randomization, Weeks 1-8 of Cycle 1, Weeks 1-3 of consecutive cycles, 28 days and 3 months after lst treatment, and every 3 months for up to 18 months from last participant randomized|ITT Population.||months||95% Confidence Interval|Median
828109|NCT01214720|Secondary|Percentage of Participants With Complete Response (CR), Partial Response (PR), or Stable Disease (SD) at First Postbaseline Tumor Assessment|Percentage of participants with CR, PR, or SD according to modified RECIST evaluation at the first postbaseline tumor assessment. CR equaled (=) complete disappearance of all target lesions and non-target disease, with normalization of tumor marker level. PR is greater than or equal to (≥) a 30% decrease of the sum of the LD of all target lesions as referenced to the baseline sum LD of all target lesions. Persistence of one or more non-target lesions(s) and/or maintenance of tumor marker level above normal limits. SD=neither sufficient shrinkage of target lesions to qualify for PR nor sufficient increase to qualify for PD with persistence of one or more non-target lesions(s) and/or maintenance of tumor marker level above normal limits.|Baseline and Week 8|ITT Population.||percentage of participants||95% Confidence Interval|Number
828110|NCT01214720|Secondary|Progression-Free Survival (PFS) - Time to Event|PFS was defined as the time between the date of randomization and the date of documented PD (per RECIST), or date of death due to any cause. Data for participants without an event were censored at the date of last follow up for progression, or date of last available tumor assessment if no further follow up assessment for progression was performed. Participants who were randomized but not exposed to study drug and had no further follow up were censored at the date of randomization. Median PFS was estimated using the Kaplan-Meier method.|Screening, Weeks 8, 16, 24, 32, 40, and every 12 weeks thereafter or until confirmed evidence of disease progression|ITT Population||months||95% Confidence Interval|Median
828111|NCT01214720|Secondary|Progression-Free Survival (PFS) - Percentage of Participants With an Event|PFS was defined as the time between the date of randomization and the date of documented progressive disease (PD) defined according to modified Response Evaluation Criteria in Solid Tumors (RECIST) evaluation, or date of death due to any cause. PD was defined as at least a 20 percent (%) increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum (LD) recorded since the treatment started. Participants without an event were censored at the date of last follow up for progression, or date of last available tumor assessment if no further follow up assessment for progression was performed. Participants who were randomized but not exposed to study drug and had no further follow up were censored at the date of randomization.|Screening, Weeks 8, 16, 24, 32, 40, and every 12 weeks thereafter or until confirmed evidence of disease progression|ITT population.||percentage of participants|||Number
828112|NCT01214720|Secondary|Clinical Benefit Response (CBR)||Randomization, Weeks 1-8 of Cycle 1, Weeks 1-3 of consecutive cycles, 28 days and 3 months after lst treatment, and every 3 months for up to 18 months from last participant randomized|The analysis of the CBR was dependent on the calculation of analgesic therapy (AT); this calculation relies on established conversion factors for different morphine derivatives (MD). Many MD utilized by participants do not have well-established conversion factors, yielding uninterpretable results. Therefore, CBR was not analyzed in this study.|||||
828113|NCT01214720|Primary|Duration of Overall Survival - Percentage of Participants With an Event|Duration of overall survival (OS) was defined as the time between date of randomization and date of death due to any cause. Participants without an event were censored at the date last known to be alive. Participants who were randomized but not exposed to study drug and had no further follow up were censored at the date of randomization.|Randomization, Weeks 1-8 of Cycle 1, Weeks 1-3 of consecutive cycles, 28 days and 3 months after lst treatment, and every 3 months for up to 18 months from last participant randomized|ITT population.||percentage of participants|||Number
828114|NCT01214759|Secondary|Safety and Tolerability as Assessed by the Number of Participants Who Completed the 28-day Course of the Antiretroviral Drugs Being Explored in This Study||28 days|All who were enrolled||participants|||Number
828115|NCT01214759|Secondary|Number of Participants Exhibiting Clinical or Laboratory Abnormalities Resulting From the 28-day Exposure to the Antiretroviral Drugs Being Explored in This Study|Participants who experienced side effects categorized as grade 3 or higher by the Division of AIDS table for grading the severity of adult and pediatric adverse events were tested for clinical or laboratory abnormalities.|28 days|Only participants who experienced side effects categorized as grade 3 or higher by the Division of AIDS table were tested for clinical or laboratory abnormalities, and since no participants experienced side effects greater than grade 1, no participants were tested for clinical or laboratory abnormalities.|||||
828116|NCT01214759|Primary|Efficacy as Assessed by the Number of Participants Who Were HIV Positive at 6 Months|This measure assesses whether the combination of Truvada and Raltegravir prevents the acquisition of HIV at six months among HIV-negative people who have been exposed to HIV.|6 months|All who completed all study visits||participants|||Number
828117|NCT01214811|Primary|Wound Area at Visit 2|At each visit the wound length and width is measured and calculated in cm2.|After one week|||cm2||Standard Deviation|Mean
828118|NCT01214811|Primary|Wound Are at Baseline||Baseline||||||
828119|NCT01214824|Secondary|Proportion of Time in Hypoglycaemia (<3.9mmol/L)-Unmasked|Proportion of time (hours per day) in hypoglycaemia (<3.9mmol/L) for the unmasked phase|2 weeks following baseline & 3 months|Analysis per protocol 31 participants analysed in the unmasked phase 1 28 participants analysed in the unmasked phase 2||Hours per day||Standard Deviation|Mean
828120|NCT01214824|Secondary|Proportion of Time in Hypoglycaemia (<3.9 mmol/L)- Masked|Proportion of time (hours per day) in hypoglycaemia (<3.9 mmol/L) for the masked phase. There were two masked phases in the study, one 5 day wear at baseline and one 5 day wear at 6 months. During masked wear subject were not able to see continuous glucose data from the device.|Baseline & 6 months|Analysis per protocol||Hours per day||Standard Deviation|Mean
828121|NCT01214824|Secondary|Number of Subjects Who Had Reduction in HbA1c of > or = 0.5%|Number of subjects with a HbA1c reduction greater than or equal to 0.5% and 95% confidence interval from visit 1 (baseline) to visit 7 (6 months).|Baseline and 6 months|Intention to treat analysis||participants|||Number
828176|NCT01214980|Secondary|Donor Site Recidivism Rate|Number of donor sites that healed and then reopened during the study.|6 weeks|Randomized subjects that had a minimum of 4 out of 5 study treatments and fully epithelialized during the study.||participants that healed and reopened|||Number
830149|NCT01227629|Secondary|Number of Participants With Thromboembolic Events: Ischemic Stroke|Occurence of an ischemic stroke (fatal or non-fatal)|12 weeks|All randomized patients. No statistical comparisons were performed, due to the extremely small number of events.||Participants|||Number
828171|NCT01214915|Secondary|Percentage of Subjects Who Responded in Platelet Count Whose Baseline Platelet Count Was <600x10^9/L|A response was defined as platelet counts to <600x10^9/L across consecutive visits for at least 4 weeks following at least 3 months of treatment.|12 months|Full Analysis Set defined as subjects who had taken at least 1 dose of study medication and had at least 1 post-baseline platelet measurement assessment.||percentage of subjects||95% Confidence Interval|Number
828172|NCT01214915|Secondary|Percentage of Subjects Who Responded in Platelet Count Whose Baseline Platelet Count Was ≥600x10^9/L|A response was defined as platelet counts to <600x10^9/L across consecutive visits for at least 4 weeks following at least 3 months of treatment.|12 months|Full Analysis Set defined as subjects who had taken at least 1 dose of study medication and had at least 1 post-baseline platelet measurement assessment.||percentage of subjects||95% Confidence Interval|Number
828173|NCT01214915|Secondary|Percentage of Subjects With Normalization in Platelet Count|Normalization was defined as platelet counts ≤400x10^9/L across consecutive visits for at least 4 weeks following at least 3 months of treatment.|12 months|Full Analysis Set defined as subjects who had taken at least 1 dose of study medication and had at least 1 post-baseline platelet measurement assessment.||percentage of subjects||95% Confidence Interval|Number
828174|NCT01214915|Secondary|Percentage of Subjects With at Least 50% Reduction in Platelet Count|Subjects who achieved at least 50% reduction in platelet count from their baseline level across consecutive visits for at least 4 weeks and following 3 months of treatment.|12 months|Full Analysis Set defined as subjects who had taken at least 1 dose of study medication and had at least 1 post-baseline platelet measurement assessment.||percentage of subjects||95% Confidence Interval|Number
828175|NCT01214915|Primary|Percentage of Subjects Who Responded in Platelet Count|A response was defined as platelet counts to <600x10^9/L across consecutive visits for at least 4 weeks following at least 3 months of treatment.|12 months|Full Analysis Set defined as subjects who had taken at least 1 dose of study medication and had at least 1 post-baseline platelet measurement assessment.||percentage of subjects||95% Confidence Interval|Number
828178|NCT01214980|Secondary|Numeric Pain Score|Average donor site pain score for each treatment group, numeric scale of 0 (no pain) to 10 (worst possible pain), at five weeks post skin graft procedure|5 weeks|randomized subjects that had a minimum of 4 out of 5 study treatments and with a numeric pain score reported||units on a scale||Standard Error|Mean
828179|NCT01214980|Secondary|Time to Full Epithelialization|Time to full epithelialization in days from the date of initial donor site harvest procedure per the blinded adjudication of the donor site image.|Days to full epithelialization|randomized subjects that had a minimum of 4 out of 5 study treatments||days||Standard Deviation|Mean
828180|NCT01214980|Primary|Rate of Wound Healing|The primary endpoint is an average of the group for each participant's donor site wound closure time, defined as days to absence of drainage from the date of the initial donor site harvest procedure.|Days to absence of drainage from the initial donor site harvest procedure|randomized participants that had a minimum of 4 out of 5 treatments||Days||Standard Deviation|Mean
828181|NCT01215032|Secondary|Percent Maintaining Glycemic Control|To describe glycemic control as assessed by hemoglobin A1C. Glycemic control was defined as maintaining fasting plasma glucose levels less than or equal to 130 mg/dL. Plasma glucose levels were measured at baseline (prior to metformin dosing), pre-month 2, pre-month 4, pre-month 7, pre-month 10 and pre-month 13, and/or at off-study visit.|2 years|Participants were stratified based on baseline hemoglobin A1c. HbA1c < 6.0 is considered normal; HbA1c >/= 6.0 is considered abnormal.||Participants|||Count of Participants
828182|NCT01215032|Secondary|Relationship Between Baseline Metabolomic Profile and PSA Response|To determine the plasma metabolomic profiles associated with response to metformin using the Metabolon platform. The Metabolon platform is a proprietary technique of metabolic profiling using mass spectrometry coupled with liquid and/or gas chromatography and robust bioinformatics. The aim is to test the hypothesis that insulin level is a biomarker that predicts activity of metformin therapy for the treatment of castrate-resistant prostate cancer.|2 years|Data was not collected for this outcome measure because blood (plasma) samples were never run on the Metabolon platform, as the study was terminated early.|||||
828183|NCT01215032|Secondary|Number of Participants With PSA Response|PSA response is defined as a 50% decline from baseline confirmed by a second PSA value 4 weeks later.|12 weeks|||Participants|||Count of Participants
828184|NCT01215032|Primary|PSA (Prostate Specific Antigen) Response|Percent change in PSA from baseline to 12 weeks.|Approximately 12 weeks|||percentage of baseline PSA||Full Range|Median
828185|NCT01215097|Secondary|Number With HbA1c at Least Lowering 0.5%|Number with HbA1c at least 0.5% lowering from baseline at week 24|baseline and at week 24|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Non-completers were considered as failure imputation (NCF).||Participants|||Number
828186|NCT01215097|Secondary|Number of Patients With HbA1c < 6.5% at Week 24 With Baseline HbA1c >= 6.5%.|Number of patients with HbA1c < 6.5% at week 24 with baseline HbA1c >= 6.5%.|baseline and at week 24|This population includes the FAS with baseline HbA1c >= 6.5%. Non-completers were considered as failure imputation (NCF).||Participants|||Number
828187|NCT01215097|Secondary|Number of Patients With HbA1c < 6.5%|Number of patients with HbA1c < 6.5% at week 24|baseline and at week 24|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Non-completers were considered as failure imputation (NCF).||Participants|||Number
828188|NCT01215097|Secondary|Number of Patients With HbA1c < 7.0% at Week 24 With Baseline HbA1c >= 7.0%.|Number of patients with HbA1c < 7.0% at week 24 with baseline HbA1c >= 7.0%.|baseline and at week 24|This population includes the FAS with baseline HbA1c >= 7.0%. Non-completers were considered as failure imputation (NCF).||Participants|||Number
828189|NCT01215097|Secondary|Number of Patients With HbA1c < 7.0%|Number of patients with HbA1c < 7.0% at week 24|baseline and at week 24|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Non-completers were considered as failure imputation (NCF).||Participants|||Number
828190|NCT01215097|Secondary|FPG Change From Baseline at Week 18|Means are treatment adjusted for baseline FPG and previous anti-diabetic medication.|Baseline and at week 18|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||mg/dL||Standard Error|Least Squares Mean
828191|NCT01215097|Secondary|FPG Change From Baseline at Week 12|Means are treatment adjusted for baseline FPG and previous anti-diabetic medication.|Baseline and at week 12|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||mg/dL||Standard Error|Least Squares Mean
828192|NCT01215097|Secondary|FPG Change From Baseline at Week 6|Means are treatment adjusted for baseline FPG and previous anti-diabetic medication.|Baseline and at week 6|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||mg/dL||Standard Error|Least Squares Mean
828193|NCT01215097|Secondary|FPG Change From Baseline at Week 24|Means are treatment adjusted for baseline fasting plasma glucose (FPG) and previous anti-diabetic medication.|Baseline and at week 24|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||mg/dL||Standard Error|Least Squares Mean
828194|NCT01215097|Secondary|HbA1c Change From Baseline at Week 24(Chinese Only)|Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and at 24 weeks|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available (Chinese only). Last observation carried forward (LOCF) was used as the imputation rule.||Percent||Standard Error|Least Squares Mean
828195|NCT01215097|Secondary|HbA1c Change From Baseline at Week 18|Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and at week 18|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||Percent||Standard Error|Least Squares Mean
828196|NCT01215097|Secondary|HbA1c Change From Baseline at Week 12|Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and at week 12|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||Percent||Standard Error|Least Squares Mean
828197|NCT01215097|Secondary|HbA1c Change From Baseline at Week 6|Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and at week 6|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||Percent||Standard Error|Least Squares Mean
828198|NCT01215097|Primary|HbA1c Change From Baseline at Week 24|Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and at week 24|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||Percent||Standard Error|Least Squares Mean
828199|NCT01215110|Secondary|Summary of Statistical Analysis of TMC207 Area Under the Concentration-time Curve Over the Dose Interval of 0 to 24 h (AUC(0-24)) on Day 1 and Day 14||Day 1 (0, 1, 3, 5, 6, 8, 12, and 24 hour post-dose) or Day 14 (0, 1, 3, 5, 6, 8, 12, and 24 hour post-dose)|On Day 14, N=13 for TMC207 300 group and N=14 for TMC207 400 group due to early withdrawal of three participants||ng*h/mL||Standard Deviation|Mean
828200|NCT01215110|Secondary|Summary of Statistical Analysis of TMC207 Time of Maximum Plasma Concentration (T(Max)) on Days 1 and 14||Day 1 (0, 1, 3, 5, 6, 8, 12, and 24 hour post-dose) or Day 14 (0, 1, 3, 5, 6, 8, 12, 24, and 30 hour post-dose)|On Day 14, N=13 for TMC207 300 group and N=14 for TMC207 400 group due to early withdrawal of three participants||hour||Standard Deviation|Mean
828201|NCT01215110|Secondary|Summary of Statistical Analysis of TMC207 Maximum Plasma Concentration Following Dosing (C(Max)) on Days 1 and 14||Day 1 (0, 1, 3, 5, 6, 8, 12, and 24 hour post-dose) or Day 14 (0, 1, 3, 5, 6, 8, 12, 24, and 30 hour post-dose)|On Day 14, N=13 for TMC207 300 group and N=14 for TMC207 400 group due to early withdrawal of three participants||ng/mL||Standard Deviation|Mean
828202|NCT01215110|Secondary|Rate of Change in Time to Sputum Culture Positivity (TTP)(Hours) in Liquid Culture Media (Days 7-14)|The TTP was measured in the Mycobacterial Growth Indicator Tube (MGIT) (Bactec MGIT960) automated liquid culture system from overnight sputum. TTP rates of change were calculated from the two slopes of the bi-linear (piece-wise) regression, for each treatment group.|Days 7-14 of fourteen consecutive days of treatment|Because of insufficient data for bilinear regression, nine participants were omitted from TTP calculations.||hours/day||Standard Deviation|Mean
828203|NCT01215110|Secondary|Rate of Change in Time to Sputum Culture Positivity (TTP)(Hours) in Liquid Culture Media (Days 2-14)|The TTP was measured in the Mycobacterial Growth Indicator Tube (MGIT) (Bactec MGIT960) automated liquid culture system from overnight sputum. TTP rates of change were calculated from the two slopes of the bi-linear (piece-wise) regression, for each treatment group.|Days 2-14 of fourteen consecutive days of treatment|Because of insufficient data for bilinear regression, nine participants were omitted from TTP calculations.||hours/day||Standard Deviation|Mean
828204|NCT01215110|Secondary|Rate of Change in Time to Sputum Culture Positivity (TTP)(Hours) in Liquid Culture Media (Days 0-2)|The TTP was measured in the Mycobacterial Growth Indicator Tube (MGIT) (Bactec MGIT960) automated liquid culture system from overnight sputum. TTP rates of change were calculated from the two slopes of the bi-linear (piece-wise) regression, for each treatment group.|Two consecutive days of treatment|Because of insufficient data for bilinear regression, nine participants were omitted from TTP calculations.||hours/day||Standard Deviation|Mean
828205|NCT01215110|Secondary|Rate of Change in Time to Sputum Culture Positivity (TTP)(Hours) in Liquid Culture Media (Days 0-14)|The TTP was measured in the Mycobacterial Growth Indicator Tube (MGIT) (Bactec MGIT960) automated liquid culture system from overnight sputum. TTP rates of change were calculated from the two slopes of the bi-linear (piece-wise) regression, for each treatment group.|Fourteen consecutive days of treatment|Because of insufficient data for bilinear regression, nine participants were omitted from TTP calculations.||hours/day||Standard Deviation|Mean
828206|NCT01215110|Secondary|Early Bactericidal Activity (EBA) Measured as the Mean Rate of Change of log10 Colony Forming Units (CFU) of M. Tuberculosis Per ml Sputum on Solid Medium Over Time (Days 0-2).|The rates of change were calculated from the two slopes of the bi-linear (piece-wise) regression, for each treatment group. The nodes (point of inflection, i.e. where slope changes) used in these bi-linear regressions, as determined by visual inspection, were Day 3.5. node. Throughout the analyses, the established node at Day 2.5 was used in the Rifafour e-275 arm. Since this range (Days0-2) is before the node day, the rate of change for this outcome is equal to the slope at Day 0. Note that to facilitate interpretation the sign of these slopes were reversed for log10CFU/ml.|Two consecutive days of treatment|Because of insufficient data for bilinear regression, four patients were omitted from EBA(CFU) calculations.||log10CFU/ml/day||Standard Deviation|Mean
828207|NCT01215110|Secondary|Early Bactericidal Activity (EBA) Measured as the Mean Rate of Change of log10 Colony Forming Units (CFU) of M. Tuberculosis Per ml Sputum on Solid Medium Over Time (Days 2-14).|The rates of change were calculated from the two slopes of the bi-linear (piece-wise) regression, for each treatment group. The nodes (point of inflection, i.e. where slope changes) used in these bi-linear regressions, as determined by visual inspection, were Day 3.5. node. Throughout the analyses, the established node at Day 2.5 was used in the Rifafour e-275 arm. Note that to facilitate interpretation the sign of these slopes were reversed for log10CFU/ml.|Days 2-14 of fourteen consecutive days of treatment|Because of insufficient data for bilinear regression, four patients were omitted from EBA(CFU) calculations.||log10CFU/ml/day||Standard Deviation|Mean
828208|NCT01215110|Secondary|Early Bactericidal Activity (EBA) Measured as the Mean Rate of Change of log10 Colony Forming Units (CFU) of M. Tuberculosis Per ml Sputum on Solid Medium Over Time (Days 7-14).|The rates of change were calculated from the two slopes of the bi-linear (piece-wise) regression, for each treatment group. The nodes (point of inflection, i.e. where slope changes) used in these bi-linear regressions, as determined by visual inspection, were Day 3.5. node. Throughout the analyses, the established node at Day 2.5 was used in the Rifafour e-275 arm. Since Day 7 is later than the node day, the rate of change for this outcome is equal to the slope at Day 14. Note that to facilitate interpretation the sign of these slopes were reversed for log10CFU/ml.|Days 7-14 of fourteen consecutive days of treatment|Because of insufficient data for bilinear regression, four patients were omitted from EBA(CFU) calculations.||log10CFU/ml/day||Standard Deviation|Mean
828209|NCT01215110|Primary|Early Bactericidal Activity (EBA) Measured as the Mean Rate of Change of log10 Colony Forming Units (CFU) of M. Tuberculosis Per ml Sputum on Solid Medium Over Time (Days 0-14).|The rates of change were calculated from the two slopes of the bi-linear (piece-wise) regression, for each treatment group. The nodes (point of inflection, i.e. where slope changes) used in these bi-linear regressions, as determined by visual inspection, were Day 3.5. node. Throughout the analyses, the established node at Day 2.5 was used in the Rifafour e-275 arm. Note that to facilitate interpretation the sign of these slopes were reversed for log10CFU/ml.|Fourteen consecutive days of treatment|Because of insufficient data for bilinear regression, four patients were omitted from EBA(CFU) calculations.||log10CFU/ml/day||Standard Deviation|Mean
828210|NCT01215123|Secondary|Treatment Duration: Number of Bevacizumab Cycles|Bevacizumab treatment duration in routine clinical practice was measured by the number of bevacizumab treatment cycles.|Up to a maximum of 36.4 months|All enrolled participants||cycles||Full Range|Median
828211|NCT01215123|Primary|Time to Disease Progression (TDP)|Time to disease progression was defined as the time interval between first-line treatment onset and investigator-assessed disease progression. Disease progression was assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Up to a maximum of 36.4 months|All enrolled participants||months||Full Range|Median
828212|NCT01215227|Primary|Percentage Change From Baseline in Total Epworth Sleepiness Scale (ESS) Score at Week 40|The ESS is a self-administered questionnaire providing a measure of a person’s general level of daytime sleepiness, or their average sleep propensity in daily life. The scale consists of 8 situations in which the participant rates their tendency to become sleepy on a scale of 0=no chance of dozing to 3=high chance of dozing. The overall score is the sum of the scores for the 8 situations for a minimum of 0 and a maximum of 24 with a higher score indicating greater sleepiness.|Baseline and Week 40|Participants in the Full Analysis Set (FAS) population (all randomized participants who received at least one dose of study drug) that had a baseline value and data at Week 40 for Total ESS Score||Percentage change||95% Confidence Interval|Mean
828213|NCT01215227|Primary|Percentage of Participants With Suicidality|The number of participants with suicidality using the Columbia - Suicide Severity Rating Scale (C-SSRS) was reported. The C-SSR was used in this study only for the purpose of safety monitoring by measuring the incidence of different types of suicidality categories during treatment. The assessment was done by the nature of the responses, not by a numbered scale. Participants who reported at least one occurrence of suicidal behavior or suicidal ideation were counted as having experienced suicidality. Suicidal behavior included suicide attempt, aborted attempt, interrupted attempt, or preparatory behavior. Suicidal ideation included a wish to die or active suicidal thought with or without method, intent or plan.|Up to 42 weeks|APaT population, which consisted of all participants who received at least one dose of study drug.||Percentage of participants|||Number
828214|NCT01215227|Primary|Percentage of Participants With Aspartate Aminotransferase (AST) ≥3 Times Upper Limit of Normal and ≥10% Increase From Baseline|The number of participants with AST ≥3 times the upper limit of normal and a ≥10% increase was reported. Laboratory safety blood work was collected from participants at Week 4, Week 6, and Week 8 visits.|Up to 42 weeks|APaT population, which consisted of all participants who received at least one dose of study drug.||Percentage of participants|||Number
828215|NCT01215227|Primary|Percentage of Participants With Alanine Aminotransferase (ALT) ≥3 Times Upper Limit of Normal and ≥10% Increase From Baseline|The number of participants with ALT ≥3 times the upper limit of normal and a ≥10% increase was reported. Laboratory safety blood work was collected from participants at Week 4, Week 6, and Week 8 visits.|Up to 42 weeks|APaT population, which consisted of all participants who received at least one dose of study drug.||Percentage of participants|||Number
828216|NCT01215227|Primary|Percentage of Participants With Diastolic Blood Pressure ≥105 mmHg|The percentage of participants with Diastolic Blood Pressure ≥105 mmHg was reported. On Day 1 and Early Termination, blood pressure was measured as follows: Participant lay supine for 5 minutes, then had blood pressure taken; then stood for 3 minutes and had blood pressure taken; then rested for 10 minutes, at which time the process was repeated twice (ie, three rounds total). For all other blood pressure measurements, the procedure needed only to be done once (ie, one round).|Up to 42 weeks|APaT population, which consisted of all participants who received at least one dose of study drug.||Percentage of participants|||Number
828217|NCT01215227|Primary|Percentage of Participants With Systolic Blood Pressure ≥180 mmHg|The percentage of participants with Systolic Blood Pressure ≥180 mm Hg was reported. On Day 1 and Early Termination, blood pressure was measured as follows: Participant lay supine for 5 minutes, then had blood pressure taken; then stood for 3 minutes and had blood pressure taken; then rested for 10 minutes, at which time the process was repeated twice (ie, three rounds total). For all other blood pressure measurements, the procedure needed only to be done once (ie, one round).|Up to 42 weeks|All Participants as Treated (APaT) population, which consisted of all participants who received at least one dose of study drug.||Percentage of participants|||Number
828218|NCT01215279|Secondary|Apparent Volume of Distribution at Steady State (Vss/F) Population Pharmacokinetic Evaluation of AZD2423 at Steady State|PK-model: 1-compartment population model with first order absorption. (Vss/F) was estimated at steady state|2 blood samples (pre- and post dose) per visit collected at weeks 1, 2 and 4|||L||Full Range|Geometric Mean
828219|NCT01215279|Secondary|Time to Reach Maximum Concentration (Tmax) Population Pharmacokinetic Evaluation of AZD2423 at Steady State|PK-model: 1-compartment population model with first order absorption. tmax was estimated at steady state|2 blood samples (pre- and post dose) per visit collected at weeks 1, 2 and 4|||Hours||Full Range|Median
828220|NCT01215279|Secondary|Cmax, Population Pharmacokinetic Evaluation of AZD2423 at Steady State|PK-model: 1-compartment population model with first order absorption. Cmaxwas estimated at steady state|2 blood samples (pre- and post dose) per visit collected at weeks 1, 2 and 4|||nmol/L||Full Range|Geometric Mean
828221|NCT01215279|Secondary|Areaa Under the Curve From 0 to 24 Hours (AUC 0-24), Population Pharmacokinetic Evaluation of AZD2423 at Steady State|PK-model: 1-compartment population model with first order absorption. AUC was estimated at steady state|2 blood samples (pre- and post dose) per visit collected at weeks 1, 2 and 4|||nmol*h/L||Full Range|Geometric Mean
828222|NCT01215279|Secondary|SAA Concentration in Plasma at End of Treatment|End of treatment = 4 weeks = Visit 6|week 4|||ng/mL||Full Range|Geometric Mean
828227|NCT01215279|Secondary|St George’s Respiratory Questionnaire for COPD (SGRQ) Total Score at Baseline|The SGRQ-C includes 40 questions in 3 domains: Symptoms (distress due to respiratory symptoms, 7 questions), Activity (disturbance of physical activity, 13 questions), Impacts (overall impact on daily life and well-being, 20 questions). Scores are expressed as a percentage. Baseline is Day 1.|Day 1|||Percent of maximum possible score||Standard Deviation|Mean
828228|NCT01215279|Secondary|Rescue Medication Use During the Last 7 Days of Treatment|Number of inhalations of short acting β2 agonist (SABA) or short acting muscarinic antagonist (SAMA) per day.|Average of the last 7 days of treatment (week 4)|||Inhalations||Full Range|Mean
828229|NCT01215279|Secondary|BCSS (Evening) Total Score During Last 7 Days of Treatment|The BCSS scale includes one question for each of the symptoms of breathlessness, cough, and sputum. The total BCSS score ranges from 0 to 12; higher scores indicate greater symptom severity. The minimally important difference has been defined as a change in total score of greater than 0.3 units.|Average of the last 7 days of treatment (week 4)|||Units on scale, 0-12||Standard Deviation|Mean
828230|NCT01215279|Secondary|Breathlessness, Cough and Sputum Scale (BCSS) (Evening) Total Score at Baseline|The BCSS scale includes one question for each of the symptoms of breathlessness, cough, and sputum. The total BCSS score ranges from 0 to 12; higher scores indicate greater symptom severity. The minimally important difference has been defined as a change in total score of greater than 0.3 units. Baseline is mean of 10 days prior to treatment.|Average of 10 days of pre-treatment measurements (day -10 to -1)|||Units on scale, 0-12||Standard Deviation|Mean
828231|NCT01215279|Secondary|EXACT Total Score During Last 7 Days of Treatment|The EXACT Tool is a Patient Reported Outcome (PRO) measure; 14 items evaluated on 5- or 6-point scales; total score ranges from 0 to 100 (higher values indicate more severe exacerbation).|Average of the last 7 days of treatment (week 4)|||Units on scale, 0-100||Standard Deviation|Mean
828232|NCT01215279|Secondary|Exacerbations of Chronic Pulmonary Disease Tool (EXACT) Total Score at Baseline|The EXACT Tool is a Patient Reported Outcome (PRO) measure; 14 items evaluated on 5- or 6-point scales; total score ranges from 0 to 100 (higher values indicate more severe exacerbation). Baseline is the mean value over the 7 days prior to randomisation.|Average of 7 days of pre-treatment measurements (day -7 to -1)|||Units on scale, 0-100||Standard Deviation|Mean
828233|NCT01215279|Secondary|Evening PEF During Last 7 Days of Treatment|Measurement conducted by patient in evening.|Average of the last 7 days of treatment (week 4)|||L/minute||Standard Deviation|Mean
828234|NCT01215279|Secondary|Evening PEF at Baseline|Measurement conducted by patient in evening.|Average of 10 days of pre-treatment measurements (day -10 to -1)|||L/minute||Standard Deviation|Mean
828235|NCT01215279|Secondary|Morning PEF During Last 7 Days of Treatment|Measurements conducted by patient in morning upon rising, before intake of morning dose of investigational product but after clearing out mucus. Patients was to refrain from taking rescue medication prior to measurement if possible.|Average of the last 7 days of treatment (week 4)|||L/minute||Standard Deviation|Mean
828236|NCT01215279|Secondary|Morning Peak Expiratory Flow (PEF) at Baseline|Measurements conducted by patient in morning upon rising, before intake of morning dose of investigational product but after clearing out mucus. Patients was to refrain from taking rescue medication prior to measurement if possible.|Average of 10 days of pre-treatment measurements (day -10 to -1)|||L/minute||Standard Deviation|Mean
828237|NCT01215279|Secondary|Evening FEV1 During Last 7 Days of Treatment|Measurement conducted by patient in evening.|Average of the last 7 days of treatment (week 4)|||L||Standard Deviation|Mean
828238|NCT01215279|Secondary|Evening FEV1 at Baseline|Measurement conducted by patient in evening.|Average of 10 days of pre-treatment measurements (day -10 to -1)|||L||Standard Deviation|Mean
828239|NCT01215279|Secondary|Morning FEV1 During Last 7 Days of Treatment|Measurements conducted by patient in morning upon rising, before intake of morning dose of investigational product but after clearing out mucus. Patients was to refrain from taking rescue medication prior to measurement if possible.|Average of the last 7 days of treatment (week 4)|||L||Standard Deviation|Mean
828240|NCT01215279|Secondary|Morning FEV1 at Baseline|Measurements conducted by patient in morning upon rising, before intake of morning dose of investigational product but after clearing out mucus. Patients was to refrain from taking rescue medication prior to measurement if possible.|Average of 10 days of pre-treatment measurements (day -10 to -1)|||L||Standard Deviation|Mean
828241|NCT01215279|Primary|Monocytes at Follow-up|Monocyte count in peripheral blood at follow-up (Week 5; 1 week after end of treatment)|week 5 (follow-up)|||10^9/L||Standard Deviation|Mean
828242|NCT01215279|Primary|Monocytes at End of Treatment|Monocyte count in peripheral blood at end of treatment (4 weeks)|week 4|||10^9/L||Standard Deviation|Mean
828243|NCT01215279|Primary|Monocytes at Baseline|Monocyte count in peripheral blood at baseline (Pre-dose, Day 1)|Day 1|||10^9/L||Standard Deviation|Mean
828244|NCT01215279|Primary|Number of Participants With Clinically Significant Changes in Physical Examination|Number of participants with clinically significant changes in physical examination assessed at all the listed time points|Day 1, 1 week, 2 weeks, 3 weeks, 4 weeks and 5 weeks (follow-up)|||Participants|||Number
828245|NCT01215279|Primary|Number of Participants With Clinically Significant Changes in ECG Variables|Number of participants with clinically significant changes in ECG variables assessed at all the listed time points|Day 1, 1 week, 2 weeks, 3 weeks, 4 weeks and 5 weeks (follow-up)|||Participants|||Number
828246|NCT01215279|Primary|Number of Participants With Clinically Significant Changes in Vital Signs|Number of participants with clinically significant changes in vital signs assessed at all the listed time points|Day 1, 1 week, 2 weeks, 3 weeks, 4 weeks and 5 weeks (follow-up)|||Participants|||Number
828247|NCT01215279|Primary|Number of Participants With Clinically Significant Changes in Laboratory Variables Other Than Monocytes|Number of all participants with clinically significant changes in laboratory variables, except monocyte, assessed at all the listed time points|Day 1, 1 week, 2 weeks, 3 weeks, 4 weeks and 5 weeks (follow-up)|||Participants|||Number
828248|NCT01215292|Primary|Intratesticular Androstenedione (ADD) Level||10 days|||ng/mL||Inter-Quartile Range|Median
828249|NCT01215292|Primary|Intratesticular Dihydrotestosterone (DHT) Level||10 days|||ng/mL||Inter-Quartile Range|Median
828250|NCT01215292|Primary|Intratesticular Testosterone (IT-T) Level||10 days|||ng/mL||Inter-Quartile Range|Median
836877|NCT01301079|Primary|Pain 60 Minutes|The scale measure pain after 60 minutes (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10.|60 minutes|||units on a scale||Standard Deviation|Mean
828251|NCT01215344|Secondary|Progression Free Survival by MRD Status at Day 100.|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|up to 7 years|Patients with MRD status information at the EOI and day 100 (post-AHCT).||years||95% Confidence Interval|Median
828252|NCT01215344|Primary|The Percent of Patients With Minimal Residual Disease (MRD) Status Changing to Negative at Day 100 (Post-AHCT), Among Patients With MRD Positive at the End of Induction (EOI).|Patients were treated with induction therapy (VRD) followed by autologous hematopoietic cell transplant (AHCT). MRD status of a patient with at least partial response was evaluated at the end of induction (EOI) and day 100 (post-AHCT). MRD of a patient is measured by seven-color flow cytometry.|6-months post ASCT|Newly diagnosed, symptomatic multiple myeloma (MM) patients. Patients were treated with induction therapy VRD followed by AHCT. MRD staus was evaluated for patients with at least partial response at the end of induction (EOI) therapy. Ten of these patients had MRD negative at EOI.||percentage of participants||95% Confidence Interval|Number
828253|NCT01215357|Secondary|Effects on the Clinical Global Impression|Clinician's Global Impression is used assess severity and changes in clinical symptoms during and at the end of the study|6 weeks||||||
828254|NCT01215357|Secondary|Statistically Significant Changes in the Gambling Symptom Assessment Scale|It is expected that there will be decreases in this scale|6 weeks||||||
828255|NCT01215357|Secondary|Type, Frequency and Severity of Side Effects|All side effects of the drug will be monitored and recorded|6 weeks||||||
828256|NCT01215357|Primary|Statistically Significant (p<0.05) Decrease From Baseline in Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling|This scale assesses the severity of gambling urges and gambling behaviors. The study anticipates that there will be a reduction in either or both of these assessments. The range is from a minimum of 0 to a maximum of 40, where zero means no gambling urges occurred.|Baseline and 6 weeks|Patients completing all visits||YBOCS score||Standard Deviation|Mean
828257|NCT01215422|Secondary|"Number of Intubation Attempts to Reach Best Obtainable Time to Intubation"|"For each anesthesiologist, the median time-to-intubation for patients #1-5, #6-10, #11-15, and #16-20 was determined. The anesthesiologist was considered to have reached Best Obtainable Time (BOT) to Intubation once the median time on any group of 5 consecutive patients was less than 3 seconds faster than the median time in the previous group of 5 consecutive patients, provided that there were no failed intubations or subsequent failed intubations using the same device."|less than 5 minutes per intubation|||participants|||Number
828258|NCT01215422|Secondary|Mean Years Since Completion of Anesthesiology Residency|To investigate whether there was a correlation between the years since completion of anesthesiology residency to the mid-point of study (2008)and median time-to-intubation for all first attempt intubations for the study. Years since completion of anesthesiology residency reported in the data table, correlation reported in the statistical analysis below|Baseline (assessed as of 2008)|||years||Full Range|Mean
828259|NCT01215422|Secondary|Time to Intubation, Stratified by Weight of Patients|To compare the time-to-intubation for these laryngoscopes in children of different weights.|4 years|Time to Intubation, Stratified by Weight of Patients||seconds||Standard Deviation|Mean
828260|NCT01215422|Secondary|Time to Intubation, Analyzed by Order of Laryngoscopes Used|To determine if the learning curve was altered by the order in which the two new laryngoscopes were learned by the anesthesiologist,mean and median times on intubations #16-20 were compared for the two videolaryngoscopes.|4 years|Only anesthesiologists who completed minimum 18 intubations with each scope were included. We report the mean of their mean times and the mean of their median times on intubations #16-20 when they should have attained a reasonable skill level.||seconds|Participants|Standard Deviation|Mean
828261|NCT01215422|Secondary|Cormack & Lehane Score|This Outcome was designed to determine if the view of the airway as determined by the Cormack & Lehane grading system is improved by use of the GlideScope (GS) video laryngoscope and/or the Karl Storz Direct Coupled Interface (DCI) (KS) video laryngoscope as this would be a surrogate marker for utility in a difficult airway. Score is reported as a whole number from I to IV with I being an easy intubation and IV being one where the larynx cannot be visualized at all.|reported during intubation (up to 5 minutes)|Patients were excluded if the Cormack-Lehane score was not recorded.||Percentage of participants|||Number
828262|NCT01215422|Primary|Success in Learning to Use a Videolaryngoscope(VLS)|"Anesthesiologists were to perform 20 intubations with each videolaryngoscopes. #1-10 were for practice. Rapid Success was no failed intubation attempts on #11-20 and a median time-to-intubation no more than 50% longer than their baseline median time-to-intubation on #11-15 . Delayed Success was achieving these same parameters on #16-20 if they were not achieved on #11-15. Operators who did not achieve either goal were labeled as having No Success."|Up to 5 minutes per intubation|Only anesthesiologists who completed minimum 18 intubations with either laryngoscope were analyzed for the primary outcome.||percent of anesthesiologists|Participants||Number
828263|NCT01215435|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes|A hypoglycaemic episode will be defined as treatment emergent if the onset of the episode is on or after the first day of trial product, and no later than the last day on trial product.|Week 0 to Week 36|Safety analysis set includes all subjects who received at least one dose of the trial product.||episodes|||Number
828264|NCT01215435|Secondary|Change in FPG (Fasting Plasma Glucose) From Baseline to Week 36|Estimated mean change from baseline in FPG after 36 weeks of treatment|Week 0, Week 36|Full analysis set (FAS) includes all randomised subjects and missing data was imputed using last observation carried forward (LOCF).||mg/dL||Standard Deviation|Mean
828265|NCT01215435|Primary|Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 11|Estimated mean change from baseline in HbA1c after 11 weeks of treatment|Week 0, Week 11|Full analysis set (FAS) includes all randomised subjects and missing data was imputed using baseline observation carried forward (BOCF)||percentage of glycosylated haemoglobin||Standard Error|Mean
828266|NCT01215513|Primary|Number of Participants With Markedly Abnormal Values in ECG Variables|This outcome measure included incidence of markedly abnormal changes in ECG variables (PR, QRS, and QT interval, QTcF, and ventricular rate). The figures present the number of participants with normal baseline and at least one post-baseline markedly abnormal value.|From baseline (day 0) to end of treatment (up to day 364)|Descriptive statistics provided a view of the 1-year safety of degarelix (CS42 and CS42A safety analysis set).||Participants|||Number
828267|NCT01215513|Secondary|Serum Levels of Prostate Specific Antigen (PSA) Over Time|PSA levels were measured over time. The figures present the median level at day 0 (n=155 participants), day 196 (n=148), day 280 (n=115), and day 364 (n=109).|Day 0, day 196, day 280, and day 364|CS42 and CS42A full analysis set (data of all participants who received at least one dose of degarelix and had at least one efficacy assessment after dosing). The figures present the median of the absolute values at day 0 (n=155 participants), day 196 (n=148), day 280 (n=115), and day 364 (n=109).||ng/mL||Full Range|Median
828268|NCT01215513|Primary|Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight|This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The figures present the number of participants with normal baseline and at least one post-baseline markedly abnormal value.|From baseline (day 0) to end of treatment (up to day 364)|Descriptive statistics provided a view of the 1-year safety of degarelix (CS42 and CS42A safety analysis set).||Participants|||Number
828269|NCT01215513|Primary|Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables|"The figures present the number of participants who had markedly abnormal levels of safety laboratory variables. Only the laboratory variables that had at least one participant with abnormal value are presented, more variables were included in the study.
ULN=upper limit of normal"|From baseline (day 0) to end of treatment (up to day 364)|Descriptive statistics provided a view of the 1-year safety of degarelix (CS42 and CS42A safety analysis set).||Participants|||Number
828270|NCT01215643|Secondary|Percentage of Participants With Viral Relapse|Viral relapse was defined as having reappearance of detectable HCV RNA after previously being undetectable (< LOD) during treatment.|within 24 weeks after the end of treatment|Full Analysis Set||percentage of participants|||Number
828271|NCT01215643|Secondary|Percentage of Participants With On-treatment Viral Breakthrough|"Viral breakthrough was defined as either:
Confirmed increase of HCV RNA ≥1 log10 above nadir (nadir = lowest HCV RNA value during treatment), or
HCV RNA becoming ≥ 100 IU/mL after previously being undetectable (< LOD) during treatment"|within 24 weeks of treatment|Full Analysis Set||percentage of participants|||Number
828272|NCT01215643|Secondary|Percentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 3)||24 weeks after the end of treatment|Participants in the Full Analysis Set with genotype 3 HCV infection||percentage of participants|||Number
828273|NCT01215643|Secondary|Percentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 2)||24 weeks after the end of treatment|Participants in the Full Analysis Set with genotype 2 HCV infection||percentage of participants|||Number
828274|NCT01215643|Secondary|Percentage of Participants With RVR Who Achieved SVR at 24 Weeks After the End of Treatment (SVR24LOQ and SVR24LOD)||24 weeks after the end of treatment|Full Analysis Set||percentage of participants|||Number
828275|NCT01215643|Secondary|Percentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 3)||12 weeks after the end of treatment|Participants in the Full Analysis Set with genotype 3 HCV infection||percentage of participants|||Number
828276|NCT01215643|Secondary|Percentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 2)||12 weeks after the end of treatment|Participants in the Full Analysis Set with genotype 2 HCV infection||percentage of participants|||Number
828277|NCT01215643|Secondary|Percentage of Participants With RVR Who Achieved Sustained Viral Response (SVR) 12 Weeks After the End of Treatment (SVR12LOQ and SVR12LOD)|SVR12LOQ and SVR12LOD were defined as Sustained Viral Response (SVR) [serum HCV RNA < LOQ and < LOD] 12 weeks after treatment, respectively.|12 weeks after the end of treatment|Full Analysis Set||percentage of participants|||Number
828278|NCT01215643|Secondary|Percentage of Participants With ETR24LOQ and ETR24LOD (Genotype 3)||at end of treatment, within 24 weeks|Participants in the Full Analysis Set with genotype 3 HCV infection||percentage of participants|||Number
828279|NCT01215643|Secondary|Percentage of Participants With ETR24LOQ and ETR24LOD (Genotype 2)||at end of treatment, within 24 weeks|Participants in the Full Analysis Set with genotype 2 HCV infection||percentage of participants|||Number
828280|NCT01215643|Secondary|Percentage of Participants With End of Treatment Response (ETR) Within 24 Weeks (ETR24LOQ and ETR24LOD)|ETR24LOQ and ETR24LOD were defined as ETR [serum HCV RNA < LOQ and < LOD] after 24 weeks of treatment or when prematurely discontinued.|at end of treatment, within 24 weeks|Full Analysis Set||percentage of participants|||Number
828281|NCT01215643|Secondary|Percentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 3)||after 12 weeks of treatment|Participants in the Full Analysis Set with genotype 3 HCV infection||percentage of participants|||Number
828282|NCT01215643|Secondary|Percentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 2)||after 12 weeks of treatment|Participants in the Full Analysis Set with genotype 2 HCV infection||percentage of participants|||Number
828283|NCT01215643|Secondary|Percentage of Participants With Complete Early Viral Response (cEVR) After 12 Weeks of Treatment (cEVR12LOQ and cEVR12LOD)|cEVR12LOQ and cEVR12LOD were defined as cEVR [serum HCV RNA < LOQ and < LOD] after 12 weeks of treatment, respectively.|after 12 weeks of treatment|Full Analysis Set||percentage of participants|||Number
828284|NCT01215643|Secondary|Percentage of Participants With RVR4LOQ and RVR4LOD (Genotype 3)||after 4 weeks of treatment|Participants in the Full Analysis Set with genotype 3 HCV infection||percentage of participants|||Number
828285|NCT01215643|Secondary|Percentage of Participants With RVR4LOQ and RVR4LOD (Genotype 2)||after 4 weeks of treatment|Participants in the Full Analysis Set with genotype 2 HCV infection||percentage of participants|||Number
828286|NCT01215643|Secondary|Percentage of Participants With RVR After 4 Weeks of Treatment < the Limit of Detection (RVR4LOD)|RVR4LOD was defined as Rapid Viral Response (RVR) [serum HCV RNA < the limit of detection (LOD), i.e., < 10 IU/mL], after 4 weeks of treatment.|after 4 weeks of treatment|Full Analysis Set||percentage of participants|||Number
828287|NCT01215643|Primary|Percentage of Participants With Rapid Viral Response (RVR) After 4 Weeks of Treatment < the Limit of Quantification (RVR4LOQ)|RVR4LOQ was defined as RVR [serum hepatitis C virus (HCV) ribonucleic acid (RNA) < the limit of quantification (LOQ), i.e., < 25 IU/mL], after 4 weeks of treatment.|after 4 weeks of treatment|Full Analysis Set (FAS), defined as all participants to whom study treatment was correctly assigned.||percentage of participants|||Number
828288|NCT01215695|Secondary|Ease of Intubation|After completion of the procedure the intubator will be asked to score the ease of intubation. To do this, he/she will give a score from 0-100 with 0 being the easiest and 100 being the hardest.|2-4 hours after intubation|||units on a scale||Standard Deviation|Mean
828290|NCT01215695|Secondary|Neck Movement|One observer will video-record the entire intubation procedure. At a later time, an otherwise unrelated observer will watch the video-records and grade the neck movement during intubation. Neck movement will be classified as Grade 0: no neck movement, Grade 1: minimal neck movement, or Grade 2: moderate neck movement. Results are reported as total with mild, moderate, or severe neck movement.|30 minutes|Only those participants with available data were analyzed for the assessment. All subjects reported had mild, moderate or severe neck movement.||Participants|||Count of Participants
828291|NCT01215695|Secondary|The Number of Intubation Attempts|counted as each approach of the ETT to the glottic entrance.|30 minutes|||Number of intubation attempts||Standard Deviation|Mean
828292|NCT01215695|Primary|Intubation Time|divided into time to successfully place the glidescope (visualization of the epiglottis), time to successfully insert the videostylet (passing through the cords) and time to verified placement of the ETT (as outlined above). Interim bag and mask time, if needed, will not be included in the intubation time. More than 5 attempts or 120 s are regarded as failure of intubation. If failure to secure the airway occurs with the GVL and videostylet, then conventional difficult intubation protocols approved by the University of Louisville Hospital will be implemented.|120 seconds|||time in seconds||Inter-Quartile Range|Median
828293|NCT01215721|Primary|Time to Continence|Days to zero pad continence were assessed by patient self-reported Pad free continence declaration card.|12 months|||Days to Continence||Standard Deviation|Median
828294|NCT01215734|Secondary|Patients Receiving HD or SD TIV With a 4-fold Rise in Hemagglutination Inhibition (HAI) Titers Relative to Baseline for Each of 3 Influenza Viruses|Adult hematopoetic stem cell transplant recipients at least 6 months post-transplant receiving either HD or SD TIV who had blood drawn at pre-vaccination and at 28-42 days post-vaccination and who experienced a 4-fold rise in each of three post-vaccination influenza antibody titers, relative to their baseline titers. Trivalent vaccine is for the H1N1/H3N2/B influenzas. A 4-fold rise in type-specific antibody titer is considered adequate antibody response to the specific influenza virus|Before TIV and 28-42 days after TIV|Patients who received either the high-dose or the standard dose TIV and who had blood drawn for HAI titers before TIV and at 28-42 days after TIV. Data not available for 5 HD and 1 SD patients.||participants|||Number
828295|NCT01215734|Primary|Patients Experiencing at Least 1 Solicited Local and/or Systemic Adverse Event After High Dose (HD) Trivalent Influenza Vaccine (TIV) or Standard Dose (SD) Trivalent Influenza Vaccine in Adult Hematopoetic Stem Cell Transplant (SCT) Recipients|Patients were questioned about the following adverse events related to TIV: Local: pain, tenderness, swelling/induration, or erythema at injection site. Systemic: fatigue/malaise, headache, nausea, vomiting, body ache not at injection site, fever >= 100.4 degrees Fahrenheit, or change in activity level.|Day of TIV to 7 days after TIV|Patients who received either the high-dose TIV or the standard dose TIV||participants|||Number
828296|NCT01215786|Secondary|Mean Concentration of AGN-207281 in Plasma at Day 14|Mean concentration of AGN-207281 in plasma at day 14. Plasma is the liquid component of the blood in which the blood cells are suspended. On day 14, the plasma sample collected 15 minutes post-morning dose from each patient receiving AGN-207281 was analyzed to determine the average drug concentration levels of AGN-207281.|Day 14|The analysis population included all patients that started the study and were treated with AGN-207281.||Picograms per milliliter (pg/mL)||Standard Deviation|Mean
828297|NCT01215786|Secondary|Mean Concentration of AGN-207281 in Plasma at Day 7|Mean concentration of AGN-207281 in plasma at day 7. Plasma is the liquid component of the blood in which the blood cells are suspended. On day 7, the plasma sample collected 15 minutes post-morning dose from each patient receiving AGN-207281 was analyzed to determine the average drug concentration levels of AGN-207281.|Day 7|The analysis population included all patients that started the study and were treated with AGN-207281.||Picograms per milliliter (pg/mL)||Standard Deviation|Mean
828298|NCT01215786|Primary|Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Day 14|Change from baseline in worse eye IOP at day 14. Worse eye IOP refers to the eye with the worse (highest) baseline IOP (a measurement of the fluid pressure inside the eye). A negative number change from baseline indicates a reduction in IOP (improvement).|Baseline, Day 14|Safety population, which consisted of all patients who started the study and received treatment.||Millimeters of mercury (mm Hg)||Standard Deviation|Mean
828299|NCT01215851|Secondary|Rate of Change in Time to Sputum Culture Positivity (TTP)(Hours) in Liquid Culture Media (Days 0-14)|The TTP was measured in the Mycobacterial Growth Indicator Tube (MGIT) (Bactec MGIT960) automated liquid culture system from overnight sputum. TTP rates of change were calculated for each individual patient from the slopes β1 and β2 of the bi-linear regression fitted to the data for each individual patient (TTP versus Day).|14 Days|In the case of patient dropout, their patient data were included in the analyses as long as enough points were recorded to allow curve fitting. The number of patients analyzed for this measure was 81.||time (h) to positive per day||Standard Deviation|Mean
828300|NCT01215851|Secondary|Early Bactericidal Activity (EBA) Measured as the Mean Rate of Change of log10 Colony Forming Units (CFU) of M. Tuberculosis Per ml Sputum on Solid Medium Over Time (Days 7-14).|Log10 CFU rates of change were calculated for each individual patient from the slopes β1 and β2 of the bi-linear regression fitted to the data for each individual patient (log10CFU versus Day). Mean log10 CFU changes from baseline were compared. A higher slope value indicates a greater change in log10 CFU from baseline. Note that to facilitate interpretation the sign of these slopes are reversed for logCFU. A positive slope value therefore indicates a reduction in log10 CFU from baseline.|Day 7-14|In the case of patient dropout, their patient data were included in the analyses as long as enough points were recorded to allow curve fitting. The number of patients analyzed for this outcome was 80.||log10CFU/ml/day||Standard Deviation|Mean
828301|NCT01215851|Secondary|Early Bactericidal Activity (EBA) Measured as the Mean Rate of Change of log10 Colony Forming Units (CFU) of M. Tuberculosis Per ml Sputum on Solid Medium Over Time (Days 2-14).|Log10 CFU rates of change were calculated for each individual patient from the slopes β1 and β2 of the bi-linear regression fitted to the data for each individual patient (log10CFU versus Day). Mean log10 CFU changes from baseline were compared. A higher slope value indicates a greater change in log10 CFU from baseline. Note that to facilitate interpretation the sign of these slopes are reversed for logCFU. A positive slope value therefore indicates a reduction in log10 CFU from baseline.|Day 2-14|In the case of patient dropout, their patient data were included in the analyses as long as enough points were recorded to allow curve fitting. The number of patients analyzed for this measure was 80.||log10CFU/ml/day||Standard Deviation|Mean
828302|NCT01215851|Secondary|Early Bactericidal Activity (EBA) Measured as the Mean Rate of Change of log10 Colony Forming Units (CFU) of M. Tuberculosis Per ml Sputum on Solid Medium Over Time (Days 0-2).|Log10 CFU rates of change were calculated for each individual patient from the slopes β1 and β2 of the bi-linear regression fitted to the data for each individual patient (log10CFU versus Day). Mean log10 CFU changes from baseline were compared. A higher slope value indicates a greater change in log10 CFU from baseline. Note that to facilitate interpretation the sign of these slopes are reversed for logCFU. A positive slope value therefore indicates a reduction in log10 CFU from baseline.|Day 0-2|In the case of patient dropout, their patient data were included in the analyses as long as enough points were recorded to allow curve fitting. The number patients analyzed for this measure was 84.||log10CFU/ml/day||Standard Deviation|Mean
828303|NCT01215851|Primary|Early Bactericidal Activity (EBA) Measured as the Mean Rate of Change of log10 Colony Forming Units (CFU) of M. Tuberculosis Per ml Sputum on Solid Medium Over Time (Days 0-14).|Log10 CFU rates of change were calculated for each individual patient from the slopes β1 and β2 of the bi-linear regression fitted to the data for each individual patient (log10CFU versus Day). Mean log10 CFU changes from baseline were compared. A higher slope value indicates a greater change in log10 CFU from baseline. Note that to facilitate interpretation the sign of these slopes are reversed for logCFU. A positive slope value therefore indicates a reduction in log10 CFU from baseline.|14 consecutive days of treatment|In the case of patient dropout, their patient data were included in the analyses as long as enough points were recorded to allow curve fitting. The number of patients analyzed for this outcome was 80.||log10CFU/ml/day||Standard Deviation|Mean
828304|NCT01215929|Primary|Measure of Methamphetamine Withdrawal|Total score on the Methamphetamine Withdrawal Assessment scale (MAWA) based on DSMIV criteria for amphetamine withdrawal. This questionnaire is comprised of 13 items which describe symptoms associated with the cessation of chronic amphetamine use for which participants indicate severity on a 4-point scale. The minimum score indicating no methamphetamine withdrawal symptoms is 0 and the maximum score is 4 indicating that a patient has the most severe withdrawal symptom related to that question. The subscales are the 13 questions and the total score is the sum of all the scores for the 13 items on the scale. The range minium and better outcome is a lower score. The range is from 0-52. The worse outcome is reflected in a higher score.|at the end of week 4|||units on a scale||Standard Error|Least Squares Mean
828305|NCT01215955|Secondary|Percentage of Participants With Severe Hypoglycemic Episodes|Severe hypoglycemia is defined as an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. These episodes may be associated with sufficient neuroglycopenia to induce seizure or coma. Plasma glucose measurements may not be available during such an event, but neurological recovery attributable to the restoration of plasma glucose to normal is considered sufficient evidence that the event was induced by low plasma glucose.|Randomization up to 24 weeks|All randomized participants except those from the excluded site.||percentage of participants|||Number
828306|NCT01215955|Secondary|The Rate of Hypoglycemic Episodes|The hypoglycemia rate per 30 days was calculated as the number of hypoglycemic episodes reported divided by the number of days at risk times 30.|Randomization through 24 weeks overall|All randomized participants except those from the excluded site.||hypoglycemic episodes per 30 day period||Standard Deviation|Mean
828307|NCT01215955|Secondary|The Number of Participants ≥65 Years of Age With Hypoglycemic Episodes (Incidence)|A hypoglycemic episode in participants ≥ 65 years of age was defined as any time a participant felt they were experiencing a sign or symptom that was associated with hypoglycemia, or had a blood glucose level of ≤70 milligram per deciliter [mg/dL, ≤3.9 millimoles per liter (mmol/L)] even if it was not associated with signs, symptoms or treatment (consistent with current American Diabetes Association 2005 guidelines).|Randomization through 24 weeks overall|All randomized participants ≥65 years old except those from the excluded site.||participants|||Number
828308|NCT01215955|Secondary|The Number of Participants With a Hypoglycemic Episode (Incidence)|A hypoglycemic episode was defined as any time a participant felt they were experiencing a sign or symptom that was associated with hypoglycemia, or had a blood glucose level of ≤70 milligram per deciliter [mg/dL, ≤3.9 millimoles per liter (mmol/L)] even if it was not associated with signs, symptoms or treatment (consistent with current American Diabetes Association 2005 guidelines).|Randomization through 24 weeks overall|All randomized participants except from the excluded site.||participants|||Number
828309|NCT01215955|Secondary|Daily Dose of Insulin Per Kilogram of Body Weight: Total, Basal and Prandial (Bolus)|Total insulin was the sum of basal insulin (glargine) that was required to manage normal daily blood fluctuations and prandial insulin that was taken at meal time. Total, basal and prandial amounts were then divided by the participant's body weight in kilograms (kg). Least Squares (LS) mean calculated using mixed model repeating measure (MMRM) analysis that included baseline, treatment, country, sulfonylurea/meglitinide use, baseline glycated hemoglobin (HbA1c) strata (≤8% and >8%), visit and treatment-by-visit interaction.|24 weeks|Full Analysis Set: all participants who completed the lead-in period (if applicable), were randomized, received ≥1 dose of study insulin and with values in the specified category, except participants from the excluded site.||international units/kilogram (IU/kg)||Standard Error|Least Squares Mean
828310|NCT01215955|Secondary|Daily Dose of Insulin: Total, Basal and Prandial (Bolus)|Total insulin was the sum of basal insulin (glargine) that was required to manage normal daily blood fluctuations and prandial insulin that was taken at meal time. Least Squares (LS) mean calculated using mixed model repeating measure (MMRM) analysis that included baseline, treatment, country, sulfonylurea/meglitinide use, baseline glycated hemoglobin (HbA1c) strata (≤8% and >8%), visit and treatment-by-visit interaction.|24 weeks|Full Analysis Set: all participants who completed the lead-in period (if applicable), were randomized, received ≥1 dose of study insulin and with values in the specified category, except participants from the excluded site.||international units (IU)||Standard Error|Least Squares Mean
828321|NCT01215968|Secondary|Time to Maximum Concentration (Tmax) of Metformin|Metformin was used as a secondary marker in the study to correlate the effect of LY2189265 on gastric emptying to the pharmacokinetics (PK) (measured as Tmax) of concomitant medications. Participants taking metformin for treatment of Type 2 Diabetes Mellitus (T2DM) underwent PK assessments for metformin in parallel to their scintigraphy assessments for gastric emptying.|Days 3, 17 and 31|All randomized participants who received both study drug and immediate release metformin, and had pharmacokinetic (PK) data. Those who violated protocol were excluded.||hour||Full Range|Median
828311|NCT01215955|Secondary|Change From Baseline to 24 Weeks in 7-Point Self-Monitored Blood Glucose (SMBG) Profile|7-Point Self-Monitored Blood Glucose profiles are measures of blood glucose concentration taken 7 time a day at the morning pre-meal, morning 2-hours (HR) postprandial (PP), midday pre-meal, midday 2-hours post-meal, evening pre-meal, bedtime and 0300 hour (3 am). Each participant took measures over any 3 days and the average was calculated for each of the 7 time points. Least Squares (LS) mean calculated using mixed model repeating measure (MMRM) analysis that included baseline, treatment, country, sulfonylurea/meglitinide use, baseline glycated hemoglobin (HbA1c) strata (≤8% and >8%), visit and treatment-by-visit interaction.|Baseline, 24 weeks|Full Analysis Set: all participants who completed the lead-in period (if applicable), were randomized, received ≥1 dose of study insulin and had values at baseline and the specified timepoint, except participants from the excluded site.||milligrams/deciliter (mg/dL)||Standard Error|Least Squares Mean
828312|NCT01215955|Secondary|Change From Baseline to 24 Week Endpoint in 1,5-anhydroglucitol (1,5-AG)|Least Squares (LS) mean calculated using mixed model repeating measure (MMRM) analysis that included baseline treatment, country, sulfonylurea/meglitinide use, baseline glycated hemoglobin (HbA1c) strata (≤8% and >8%), visit and treatment-by-visit interaction.|Baseline, 24 weeks|Full Analysis Set: all participants who completed the lead-in period (if applicable), were randomized, received ≥1 dose of study insulin with baseline 1,5-AG value, except participants from the excluded site.||microgram/milliliter (mcg/mL)||Standard Error|Least Squares Mean
828313|NCT01215955|Secondary|Change From Baseline to 24 Week Endpoint in Fasting Glucose in Participants ≥65 Years of Age|Least Squares (LS) mean calculated using mixed model repeating measure (MMRM) analysis that included baseline, treatment, country, sulfonylurea/meglitinide use, baseline glycated hemoglobin (HbA1c) strata (≤8% and >8%), visit and treatment-by-visit interaction.|Baseline, 24 weeks|A subset of the Full Analysis Set: all participants who completed the lead-in period (if applicable), were randomized, received ≥1 dose of study insulin, who are ≥65 years of age with baseline fasting glucose values, except participants from the excluded site.||millimoles/liter (mmoles/L)||Standard Error|Least Squares Mean
828314|NCT01215955|Secondary|Change From Baseline to 24 Week Endpoint in Fasting Glucose|Least Squares (LS) mean calculated using mixed model repeating measure (MMRM) analysis that included baseline, treatment, country, sulfonylurea/meglitinide use, baseline glycated hemoglobin (HbA1c) strata (≤8% and >8%), visit and treatment-by-visit interaction.|Baseline, 24 weeks|Full Analysis Set: all participants who completed the lead-in period (if applicable), were randomized, received ≥1 dose of study insulin with baseline fasting glucose values, except participants from the excluded site.||millimoles/liter (mmoles/L)||Standard Error|Least Squares Mean
828315|NCT01215955|Secondary|Time to Reach Glycated Hemoglobin (HbA1c) Target Values|Percentage of participants is the number of participants who achieved HbA1c target values of ≤6.5% or ≤7.0% during the specified time period divided by the total number of participants who did not discontinue from the study but had not reached HbA1c target at the beginning of the specified post baseline time period (≤100 days and ≥101 days). Participants who did not experience an outcome before discontinuation or completion of the study were censored using the date of discontinuation. Participants who were lost to follow up the date of discontinuation were considered to be the date of last contact.|Baseline through 24 weeks|Full Analysis Set: all participants who completed the lead-in period (if applicable), were randomized, received ≥1 dose of study insulin, except participants from the excluded site. Censored participants: Study A: ≤6.5% Q1D=186 and Q3D=197; Study A ≤7.0% Q1D=120 and Q3D=134; Study B: ≤6.5% Q1D=206 and Q3D=212, Study B ≤7.0% Q1D=135 and Q3D=152.||percentage of participants|||Number
828316|NCT01215955|Secondary|Change From Baseline to 24 Week Endpoint in Body Weight|Body weight was measured twice at each indicated visit and the average of the 2 measurements was used for analyses. Least Squares (LS) mean calculated using mixed model repeating measure (MMRM) analysis that included baseline, treatment, country, sulfonylurea/meglitinide use, baseline glycated hemoglobin (HbA1c) strata (≤8% and >8%), visit and treatment-by-visit interaction .|Baseline, 24-weeks|Full Analysis Set: all participants who completed the lead-in period (if applicable), were randomized and received ≥1 dose of study insulin with a baseline body weight, except participants from the excluded site.||kilograms (kg)||Standard Error|Least Squares Mean
828317|NCT01215955|Secondary|Percentage of Participants ≥65 Years of Age Achieving Glycated Hemoglobin (HbA1c) Target Concentration|Percentage of participants ≥65 years of age achieving HbA1c target concentration of ≤7.0% or ≤6.5%.|24-week endpoint|A subset of the Full Analysis Set: all participants who completed the lead-in period (if applicable), were randomized, received ≥1 dose of study insulin and were ≥65 years of age, except participants from the excluded site. Last observation carried forward (LOCF) was used.||percentage of participants|||Number
828318|NCT01215955|Secondary|Percentage of Participants Achieving Glycated Hemoglobin (HbA1c) Target Values|Percentage of participants who achieved HbA1c levels of ≤7.0% or ≤6.5%.|24-week endpoint|Full Analysis Set: all participants who completed the lead-in period (if applicable), were randomized, received ≥1 dose of study insulin, except participants from the excluded site; last observation carried forward (LOCF) was used.||percentage of participants|||Number
828319|NCT01215955|Primary|Change From Baseline to 24 Week Endpoint in Glycated Hemoglobin (HbA1c)|The change from baseline to 24 weeks in the percentage of HbA1c in plasma. The Least Squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included the independent variables: fixed effects for treatment, country, sulfonylurea/meglitinide use, visit, treatment by visit interaction with baseline HbA1c as a covariate.|Baseline, 24 weeks|Full Analysis Set: All participants who completed the lead-in period (if applicable), were randomized, received ≥1 dose of study insulin with a baseline value for HbA1C, except participants from the excluded site.||percentage HbA1c||Standard Error|Least Squares Mean
828320|NCT01215968|Secondary|Number of Participants With Clinically Significant Effects|Adverse events (AEs) were considered clinically significant effects. A summary of serious adverse events (SAEs) and other nonserious AEs are located in the Reported Adverse Event section.|Baseline through 5 weeks|All enrolled participants who received at least one dose of study drug.||participants|||Number
828341|NCT01217073|Secondary|Mean 2h-PMG Level at Baseline of the Extension Period|Plasma 2h-PMG levels were measured at baseline (Week 0) for participants who entered the extension period.|Baseline (Week 0)|All participants who entered the extension period of the study with available 2h-PMG baseline data.||mg/dL||Standard Deviation|Mean
828322|NCT01215968|Secondary|Maximum Concentration (Cmax) of Metformin|Metformin was used as a secondary marker in the study to correlate the effect of LY2189265 on gastric emptying to the pharmacokinetics (PK) (measured as Cmax) of concomitant medications. Participants taking metformin for treatment of Type 2 Diabetes Mellitus (T2DM) underwent PK assessments for metformin in parallel to their scintigraphy assessments for gastric emptying.|Days 3, 17 and 31|All randomized participants who received both study drug and immediate release metformin, and had pharmacokinetic (PK) data. Those who violated protocol were excluded.||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
828323|NCT01215968|Secondary|Area Under the Curve (AUC) of Metformin|Metformin was used as a secondary marker in the study to correlate the effect of LY2189265 on gastric emptying to the pharmacokinetics (PK) (measured as AUC) of concomitant medications. Participants taking metformin for treatment of Type 2 Diabetes Mellitus (T2DM) underwent PK assessments for metformin in parallel to their scintigraphy assessments for gastric emptying. AUC of metformin was calculated during one dosing interval.|Days 3, 17 and 31|All randomized participants who received both study drug and immediate release metformin, and had PK data. Those who violated protocol were excluded.||nanograms*hour/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
828324|NCT01215968|Primary|Time Required for 50% of Radioactivity To Be Emptied From the Stomach by Scintigraphy|After at least 8 hours fasting, participants received a radiolabeled breakfast containing technetium-99m-tin colloid (99mTc-tin colloid). After which serial anterior and posterior scintigraphy images were taken. Data presented are the time required for 50% of radioactivity to be emptied from stomach. The results presented are Geometric Least Squares (LS) Mean. LS Mean values were controlled for weeks.|Days 3, 10,17, 24 and 31|All randomized participants who received study drug, a radiolabeled breakfast, and had scintigraphy images taken. Those who violated protocol were excluded.||hours||90% Confidence Interval|Geometric Mean
828325|NCT01215981|Secondary|Number of Subjects With H3 Based Immune Response to Vaccine|The secondary endpoint of this study is to measure the response to the vaccine with laboratory studies including viral specific H3 immune responses (IFN-y Elispot). Response is defined as 4 fold increase in H3N1. Response is listed as a number of subjects (evaluable) that successfully responded.|8 Weeks After Vaccination|One of the 33 participants randomized to receive 1 vaccine dose died prior to the 8 week evaluation.||Patients|||Number
828326|NCT01215981|Primary|Number of Subjects With T-Cell Based Immune Response to Vaccine|The primary endpoint of this study is to measure the response to the vaccine with laboratory studies including viral specific T cell immune responses. Response is defined as 4 times above the background after a filter plate was developed. Response is listed as a number of subjects (evaluable) that successfully responded.|8 Weeks After Vaccination|One of the 33 participants randomized to receive 1 vaccine dose died prior to the 8 week evaluation.||Patients|||Number
828327|NCT01216072|Secondary|Physician-reported Clinical Global Impression of Improvement (CGI-I)|The CGI-I is a rating scale allowing a physician-reported global evaluation of the subject's improvement over time. The Investigator assessed the subject's clinical change relative to the symptoms at baseline on the CGI-I, a seven-point scale, with rating as follows: 1=Very much improved, 2=Much improved, 3=Minimally improved, 4=No change, 5=Minimally worse, 6=Much worse, 7=Very much worse. The assessments were completed at Month 3 and Month 6. A lower score indicates improvement.|Month 3, Month 6|This analysis was conducted using the Full Analysis Set. The Full Analysis Set comprised all randomized patients to whom study medication was assigned. Patients with month 3 and month 6 assessments were included in this analysis. Missing values were imputed using the Last Observation Carried Forward (LOCF) method.||units on a scale||Standard Deviation|Mean
828328|NCT01216072|Secondary|Change From Baseline in Patient-reported Depression Using the Beck Depression Inventory (BDI-II)|The Beck Depression Inventory (BDI-II) is a 21-question multiple-choice self-report inventory. Each item is scored from 0 to 3. The questions in the BDI-II refer to how the patient has been feeling over the past two weeks specifically. The BDI-II total score was calculated by summing the 21 item scores. Final scores ranged from 0 to 63 where higher scores indicated more severe depression. If no more than 20% of the items were missing, the total score was the product of the mean response of the non-missing items and the total number of items. If more than 20% of all items were missing, the total score was set to missing. A negative change indicates improvement.|Baseline, Month 3, Month 6|This analysis was conducted using the Full Analysis Set. The Full Analysis Set comprised all randomized patients to whom study medication was assigned. Patients with baseline to 3 month assessments and/or baseline to 6 month assessments were included in this analysis.||units on a scale||Standard Deviation|Mean
828329|NCT01216072|Secondary|Change From Baseline in Patient-reported Health-related Quality-of-life Using the Short Form Health Survey v2 Standard (SF-36 v2)|The SF-36v2 is a validated health-related quality of life instrument used in numerous disease states, including MS. It is a self-administered survey that measures 8 domains of health including: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems and general mental health. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). If half or more questions within a domain were answered, then a score was calculated for that domain. Otherwise, the patient score for that domain was set to missing. If the patient was missing any 1 of the 8 scale scores, then the physical and mental component scores were set to missing. An algorithm was used to create a score from 0 to 100 for each domain score and component score. A positive change from baseline indicates improvement.|Baseline, Month 6|This analysis was conducted using the Full Analysis Set. The Full Analysis Set comprised all randomized patients to whom study medication was assigned. Patients with both baseline and 6 month assessments were included in this analysis. Missing values were imputed using the Last Observation Carried Forward (LOCF) method.||units on a scale||Standard Deviation|Mean
828330|NCT01216072|Secondary|Change From Baseline in the Patient-reported Convenience Subscale Using the TSQM v1.4|The convenience subscale was scored as follows: questions 9 and 10 scored as 1(extremely difficult) to 7 (extremely easy), and question 11 scored as 1(extremely inconvenient) to 7 (extremely convenient). The scores of the domain were added together and an algorithm was used to create a score of 0 to 100. Higher scores indicated greater satisfaction. A positive change from baseline indicates improvement.|Baseline, Month 6|This analysis was conducted using the Full Analysis Set. The Full Analysis Set comprised all randomized patients to whom study medication was assigned. Patients with both baseline and 6 month assessments were included in this analysis.||units on a scale||Standard Deviation|Mean
828331|NCT01216072|Secondary|Change From Baseline in the Patient-reported Side Effects Subscale Using the TSQM v1.4|The Side Effects subscale was scored as follows: question 4 scored as 0(no) or 1(yes); question 5 scored as 1(extremely bothersome) to 5(not at all bothersome); and questions 6 - 8 scored as 1(a great deal) to 5(not at all). The scores of the domain were added together and an algorithm was used to create a score of 0 to 100. Higher scores indicated greater satisfaction. A positive change from baseline indicates improvement.|Baseline, Month 6|This analysis was conducted using the Full Analysis Set. The Full Analysis Set comprised all randomized patients to whom study medication was assigned. Patients with both baseline and 6 month assessments were included in this analysis.||units on a scale||Standard Deviation|Mean
828332|NCT01216072|Secondary|Change From Baseline in the Patient-reported Effectiveness Subscale Using the TSQM v1.4|The effectiveness scale was scored as follows: 1(extremely dissatisfied) to 7(extremely satisfied). The scores of the domain were added together and an algorithm was used to create a score of 0 to 100. Higher scores indicated greater satisfaction. A positive change from baseline indicates improvement.|Baseline, Month 6|This analysis was conducted using the Full Analysis Set. The Full Analysis Set comprised all randomized patients to whom study medication was assigned. Patients with both baseline and 6 month assessments were included in this analysis.||units on a scale||Standard Deviation|Mean
828333|NCT01216072|Secondary|Change From Baseline in Patient-reported Fatigue Using the Fatigue Severity Scale (FSS)|The Fatigue Severity Scale (FSS) is a 9-item assessment scale measuring fatigue and its effects, using a scale from 1 to 7, with higher scores indicating greater fatigue, or greater negative effects of fatigue on daily living. The FSS 9 item total score was calculated by summing the first 9 item scores and dividing by the number of non-missing items. If no more than 20% of the items were missing, the total score was the product of the mean response of the non missing items and the total number of items. If more than 20% of all items were missing, the total score was set to missing. A negative change from baseline indicates improvement.|Baseline, Month 3, Month 6|This analysis was conducted using the Full Analysis Set. The Full Analysis Set comprised all randomized patients to whom study medication was assigned. Patients with baseline to 3 month assessments and/or baseline to 6 month assessments were included in this analysis.||units on a scale||Standard Deviation|Mean
828334|NCT01216072|Secondary|Change From Baseline in Patient-reported Activities of Daily Living (ADL) Using the Multiple Sclerosis Activities Scale (PRIMUS-Activities) at Month 6|The PRIMUS activity measure is a 15-item assessment of patient-reported ADL. The PRIMUS-Activities total score was calculated by summing the 15 item scores after recoding the responses from 1 - 3 to 0 - 2. Totals scores range from 0 to 30 with higher scores indicating greater activity limitation. If no more than 20% of the items were missing, the total score was the product of the mean response of the non-missing items and the total number of items. If more than 20% of all items were missing, the total score was set to missing. A negative change from baseline indicates improvement.|Baseline, Month 6|This analysis was conducted using the Full Analysis Set. The Full Analysis Set comprised all randomized patients to whom study medication was assigned. Patients with both baseline and 6 month assessments were included in this analysis. Missing values were imputed using the Last Observation Carried Forward (LOCF) method.||units on a scale||Standard Deviation|Mean
828335|NCT01216072|Secondary|Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Death|In this analysis, patients with all (serious and non-serious) adverse events, serious adverse events and death were reported.|9 months (6 month core + 3 month Extension)|Safety Set included all patients who received at least one dose of study drug.||Participants|||Number
828336|NCT01216072|Primary|Change From Baseline in the Global Satisfaction Subscale of the Treatment Satisfaction Questionnaire for Medication (TSQM) at Month 6|The TSQM was developed and validated as a general measure for treatment satisfaction. It contains 14 items assessing the following 4 domains: effectiveness (sum of scores for questions 1 - 3), side effects (sum of scores for questions 4 - 8), convenience (sum of scores for questions 9 - 11) and Global Satisfaction (sum of scores for questions 12 - 14). The primary analysis was on Global Satisfaction. Question 12 scored as 1(not at all confident) to 5 (extremely confident); question 13 scored as 1(not at all certain) to 5(extremely certain); and question 14 scored as 1(extremely dissatisfied) to 7(extremely satisfied). The scores of the domain were added together and an algorithm was used to create a score of 0 to 100. Higher scores indicated greater satisfaction. A positive change from baseline indicates improvement.|Baseline, Month 6|This analysis was conducted using the Full Analysis Set. The Full Analysis Set comprised all randomized patients to whom study medication was assigned. Patients with both baseline and 6 month assessments were included in this analysis.||units on a scale||Standard Deviation|Mean
828337|NCT01216943|Primary|Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye|IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the mean of the IOP values at hour 0, hour 2 and hour 8 at each visit in the study eye. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase in IOP (worsening).|Baseline, Week 12|Modified Intent to Treat: includes all qualified patients with a baseline and at least 1 postbaseline efficacy evaluation||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
828338|NCT01217073|Secondary|Change From Baseline in FPG Levels at Week 78|Change from baseline was calculated by subtracting the baseline level from the Week 78 level.|Baseline (Week 0) and Week 78|Extension full analysis set population defined as all randomized participants who received at least one dose of extension study treatment, have baseline and at least one post-randomization observation for the analysis endpoint subsequent to at least one dose of extension study treatment.||mg/dL||95% Confidence Interval|Least Squares Mean
828339|NCT01217073|Secondary|Mean FPG Level at Baseline of the Extension Period|Plasma FPG levels were measured at baseline (Week 0) for particiapnts who entered the extension period.|Baseline (Week 0)|All participants who entered the extension period of the study with available FPG baseline data.||mg/dL||Standard Deviation|Mean
828340|NCT01217073|Secondary|Change From Baseline in 2h-PMG at Week 78|Change from baseline was calculated by subtracting the baseline level from the Week 78 level.|Baseline (Week 0) and Week 78|Extension full analysis set population defined as all randomized participants who received at least one dose of extension study treatment, have baseline and at least one post-randomization observation for the analysis endpoint subsequent to at least one dose of extension study treatment.||mg/dL||95% Confidence Interval|Least Squares Mean
828342|NCT01217073|Secondary|Change From Baseline in Plasma A1C Levels at Week 78|A1C levels were measured as a percent. Change from baseline was calculated by subtracting the baseline level from the Week 78 level.|Baseline (Week 0) and Week 78|Extension full analysis set population defined as all randomized participants who received at least one dose of extension study treatment, have baseline and at least one post-randomization observation for the analysis endpoint subsequent to at least one dose of extension study treatment.||Percent||95% Confidence Interval|Least Squares Mean
828343|NCT01217073|Secondary|Mean Plasma A1C Level at Baseline of the Extension Period|A1C levels were measured as a percent at baseline (Week 0) for participants who entered the extension period.|Baseline (Week 0)|All participants who entered the extension period of the study with available A1C baseline data.||Percent||Standard Deviation|Mean
828344|NCT01217073|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) Levels at Week 12|Change from baseline was calculated by subtracting the baseline level from the Week 12 level.|Baseline (Week 0) and Week 12|Full analysis set defined as all randomized participants who received at least one dose of study treatment and had a baseline measurement or a post-randomization measurement for the analysis endpoint subsequent to at least one dose of study treatment.||mg/dL||95% Confidence Interval|Least Squares Mean
828345|NCT01217073|Secondary|Change From Baseline in 2 Hour-post-meal Glucose (2h-PMG) Levels at Week 12|Change from baseline was calculated by subtracting the baseline level from the Week 12 level.|Baseline (Week 0) and Week 12|Full analysis set defined as all randomized participants who received at least one dose of study treatment and had a baseline measurement or a post-randomization measurement for the analysis endpoint subsequent to at least one dose of study treatment.||mg/dL||95% Confidence Interval|Least Squares Mean
828346|NCT01217073|Primary|Percentage of Participants Who Discontinued From Study Drug Due to an Adverse Event During the 66-week Extension Period|An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor’s product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor’s product, is also an adverse event. Data presented below excludes data after the initiation of glycemic rescue.|Up to 66 weeks (Weeks 12 to 78)|Analysis population defined as all randomized participants who received at least one dose of extension study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Participants who received glycemic rescue during the base period were excluded from this analysis population.||Percentage of participants|||Number
828347|NCT01217073|Primary|Percentage of Participants Who Experienced at Least One Adverse Event During the 66-week Extension Period|An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor’s product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor’s product, is also an adverse event. Data presented below excludes data after the initiation of glycemic rescue.|Up to 70 Weeks (Weeks 12 to 78 plus 4-week follow-up period)|Analysis population defined as all randomized participamts who received at least one dose of extension study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Participants who received glycemic rescue during the base period were excluded from this analysis population.||Percentage of participants|||Number
828348|NCT01217073|Primary|Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event During the 12-week Base Period|An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor’s product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of the Sponsor’s product, is also an adverse event. Data presented below excludes data after the initiation of glycemic rescue.|Up to 12 weeks|The all participants as treated population defined as all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received during the study.||Percentage of participants|||Number
828349|NCT01217073|Primary|Percentage of Participants Who Experienced at Least One Adverse Event During the Base Period|An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor’s product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of the Sponsor’s product, is also an adverse event. Data presented below excludes data after the initiation of glycemic rescue.|Up to 16 weeks (including 28 days following the last dose of study drug)|The all participants as treated population defined as all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received during the study.||Percentage of participants|||Number
828350|NCT01217073|Primary|Change From Baseline in Plasma A1C Levels at Week 12|A1C levels were measured as a percent. Change from baseline was calculated by subtracting the baseline level from the Week 12 level.|Baseline (Week 0) and Week 12|Full analysis set defined as all randomized participants who received at least one dose of study treatment and had a baseline measurement or a post-randomization measurement for the analysis endpoint subsequent to at least one dose of study treatment.||Percent||95% Confidence Interval|Least Squares Mean
828362|NCT01217112|Secondary|The Change From Baseline in Mean Total Abdominal Fat After 91 Days (13 Weeks) of Treatment|Total Abdominal Fat was measured by magnetic resonance imaging, and the results of the scans were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||litres||Standard Deviation|Mean
829107|NCT01216397|Primary|Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval 0 to 72 Hours (AUC0-72)|Geometric mean of AUC0-72 of Linagliptin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set||nmol*hr/L||Geometric Coefficient of Variation|Geometric Mean
828351|NCT01217112|Secondary|The Change From Baseline in Mean Beck Depression Inventory-II (BDI-II) Score at the End of 91 Days (13 Weeks) of Treatment|The BDI-II is a 21 question, multiple choice, self-reported inventory, and is one of the most widely used instruments for measuring the severity of depression. The 21 questions or items each had four possible responses. Each response was assigned a score ranging from zero to three, indicating the severity of the symptom, with a total possible score ranging from zero to 63. A score between zero and 13 indicates ‘minimal depression’. A score between 14 and 19 indicates ‘mild depression’. A score between 20 and 28 indicates ‘moderate depression’, and a score between 29 and 63 indicates ‘severe depression’. As such, an increase from baseline to the end of treatment, a positive value, indicates a deterioration.|Baseline (Day 1) and the End of Treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||units on a scale||Standard Deviation|Mean
828352|NCT01217112|Secondary|Adverse Events as a Measure of Patient Safety|The incidence of treatment-emergent adverse events was recorded for the study duration, and the number of patients who experienced an adverse event is presented.|Day 1 - Day 92|All correctly randomised subjects who received at least one dose of study treatment were included and analysed according to the treatment received.||participants|||Number
828353|NCT01217112|Secondary|The Change From Baseline in Mean Appetite 0-10 Numerical Rating Scale Score After 91 Days (13 Weeks) of Treatment|Subjects scored their appetite daily using an appetite 0-10 numerical rating scale score where 0 = no appetite (don't feel hungry) and 10 = maximum appetite (completely hungry all the time). The mean change from baseline to the end of treatment in scores were calculated. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||units on a scale||Standard Deviation|Mean
828354|NCT01217112|Secondary|The Change From Baseline in Mean % Liver Fat After 91 Days (13 Weeks) of Treatment|Percentage liver fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment in base per cent values, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||percent liver fat||Standard Deviation|Mean
828355|NCT01217112|Secondary|The Change From Baseline in Mean Abdominal Adiposity After 91 Days (13 Weeks) of Treatment|Abdominal Adiposity was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||litres||Standard Deviation|Mean
828356|NCT01217112|Secondary|The Change From Baseline in Mean Total Fat After 91 Days (13 Weeks) of Treatment|Total Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||litres||Standard Deviation|Mean
828357|NCT01217112|Secondary|The Change From Baseline in Mean Total Subcutaneous Fat After 91 Days (13 Weeks) of Treatment|Total Subcutaneous Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||litres||Standard Deviation|Mean
828358|NCT01217112|Secondary|The Change From Baseline in Mean Total Internal Fat After 91 Days (13 Weeks) of Treatment|Total Internal Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||litres||Standard Deviation|Mean
828359|NCT01217112|Secondary|The Change From Baseline in Mean Total Non-Abdominal Fat After 91 Days (13 Weeks) of Treatment|Total Non-Abdominal Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||litres||Standard Deviation|Mean
828360|NCT01217112|Secondary|The Change From Baseline in Mean Subcutaneous Non-Abdominal Fat After 91 Days (13 Weeks) of Treatment|Subcutaneous Non-Abdominal Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||litres||Standard Deviation|Mean
828361|NCT01217112|Secondary|The Change From Baseline in Mean Internal Non-Abdominal Fat After 91 Days (13 Weeks) of Treatment|Internal Non-Abdominal Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||litres||Standard Deviation|Mean
829108|NCT01216397|Primary|Linagliptin: Maximum Measured Concentration (Cmax)|Geometric mean of Cmax of Linagliptin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set||nmol/L||Geometric Coefficient of Variation|Geometric Mean
828363|NCT01217112|Secondary|The Change From Baseline in Mean Subcutaneous Abdominal Fat After 91 Days (13 Weeks) of Treatment|Subcutaneous Abdominal Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scans were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||litres||Standard Deviation|Mean
828364|NCT01217112|Secondary|The Change From Baseline in Mean Visceral Abdominal Fat After 91 Days (13 Weeks) of Treatment|Visceral Abdominal Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scans were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||litres||Standard Deviation|Mean
828365|NCT01217112|Secondary|The Change From Baseline in Mean Hip Measurement After 91 Days (13 Weeks) of Treatment|Subjects' hip measurements were taken at baseline and the end of treatment. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||cm||Standard Deviation|Mean
828366|NCT01217112|Secondary|The Change From Baseline in Mean Waist Measurement After 91 Days (13 Weeks) of Treatment|Subjects' waist measurements were taken at baseline and the end of treatment. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||cm||Standard Deviation|Mean
828367|NCT01217112|Secondary|The Change From Baseline in Mean Body Weight After 91 Days (13 Weeks) of Treatment|Subject's body weights were measured at baseline and the end of treatment. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||kg||Standard Deviation|Mean
828368|NCT01217112|Secondary|The Change From Baseline in Mean Waist-to-hip Ratio After 91 Days (13 Weeks) of Treatment|Subject's waist-to-hip ratios were calculated at baseline and the end of treatment. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||ratio||Standard Deviation|Mean
828369|NCT01217112|Secondary|The Change From Baseline in Mean Body Mass Index After 91 Days (13 Weeks) of Treatment|Body Mass Index was calculated at baseline and the end of treatment. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||kg/m^2||Standard Deviation|Mean
828370|NCT01217112|Secondary|The Change From Baseline in Mean Insulin B Cell Function Measured by Homeostasis Model Assessment 2 (HOMA2) After 91 Days (13 Weeks) of Treatment|Changes from baseline to the end of treatment in mean insulin B Cell Function were calculated by HOMA2. HOMA2-IR is a computer model that uses fasting plasma insulin and glucose concentrations to estimate beta cell function (%B) as a percentage of a normal reference population (normal young adults). An increase from baseline to the end of treatment, a positive value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||percent beta function||Standard Deviation|Mean
828371|NCT01217112|Secondary|The Change From Baseline in Mean Insulin Sensitivity Measured by Homeostasis Model Assessment 2 (HOMA2) After 91 Days (13 Weeks) of Treatment|Changes from baseline to the end of treatment in mean insulin sensitivity were calculated by HOMA2. HOMA2-IR is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S) as a percentage of a normal reference population (normal young adults). An increase from baseline to the end of treatment, a positive value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||percent sensitivity||Standard Deviation|Mean
828372|NCT01217112|Secondary|The Change From Baseline in Mean Insulin Resistance Measured by Homeostasis Model Assessment 2 (HOMA2-IR) After 91 Days (13 Weeks) of Treatment|Changes from baseline to the end of treatment in mean insulin resistance were calculated by HOMA2-IR. HOMA2-IR is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin resistance, which is the reciprocal of insulin sensitivity (%S)(100/%S) as a percentage of a normal reference population (normal young adults). A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||IR score||Standard Deviation|Mean
828373|NCT01217112|Secondary|The Change From Baseline in Mean C-peptide Concentration After 91 Days (13 Weeks) of Treatment|At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of C-peptide concentrations. An increase from baseline to the end of treatment, a positive value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||nmol/l||Standard Deviation|Mean
828374|NCT01217112|Secondary|The Change From Baseline in Mean Fasting Insulin Concentration After 91 Days (13 Weeks) of Treatment|At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of fasting insulin concentrations. An increase from baseline to the end of treatment, a positive value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||pmol/l||Standard Deviation|Mean
828375|NCT01217112|Secondary|The Change From Baseline to the End of 91 Days (13 Weeks) of Treatment in the Mean Serum Insulin Concentration Two Hours Post Glucose Challenge (Oral Glucose Tolerance Test)|At baseline and the end of treatment, blood samples were taken at -15 and 0 minutes prior to a glucose drink and at 30, 60, 90, 120 and 180 minutes post drink. The OGTT measured the change from baseline in serum insulin levels at two hours (120 minutes) compared to 0 minutes. The extent of the elevation in blood glucose levels following a glucose drink were compared between baseline and the end of treatment. An increase in the elevation of serum insulin levels from baseline to the end of treatment (i.e. a positive value) indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||pmol/l||Standard Deviation|Mean
828376|NCT01217112|Secondary|The Change From Baseline to the End of 91 Days (13 Weeks) of Treatment in the Mean Serum Glucose Concentration Two Hours Post Glucose Challenge (Oral Glucose Tolerance Test [OGTT])|A two-hour OGTT was performed to investigate the rate of glucose metabolism or clearance from the blood with treatment. Blood samples were taken at -15 and 0 minutes prior to a glucose drink and at 30, 60, 90, 120 and 180 minutes post drink. The OGTT measured the change from baseline in serum glucose levels at two hours (120 minutes) compared to 0 minutes. The extent of the elevation in blood glucose levels following a glucose drink were compared between baseline and the end of treatment. A reduction in the elevation of serum glucose levels at the end of treatment (i.e. a negative value) indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||mmol/l||Standard Deviation|Mean
828377|NCT01217112|Secondary|The Change From Baseline in Mean Glycated Haemoglobin Concentration After 91 Days (13 Weeks) of Treatment|At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of glycated haemoglobin concentrations. At both time points, values were calculated as a percentage of total haemoglobin. A decrease from baseline to the end of treatment in base per cent values, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||percent||Standard Deviation|Mean
828378|NCT01217112|Secondary|The Change From Baseline in Mean Fructosamine Concentration After 91 Days (13 Weeks) of Treatment|At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of fructosamine concentrations. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||umol/l||Standard Deviation|Mean
828379|NCT01217112|Secondary|The Change From Baseline in Mean Fasting Glucose Concentration After 91 Days (13 Weeks) of Treatment|At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of fasting glucose concentrations. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||mmol/l||Standard Deviation|Mean
828380|NCT01217112|Secondary|The Change From Baseline in Mean Serum Non-Esterified Fatty Acid Concentration After 91 Days (13 Weeks) of Treatment|At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum Non-Esterified Fatty Acid concentrations. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||mmol/l||Standard Deviation|Mean
828381|NCT01217112|Secondary|The Change From Baseline in Mean Serum Apolipoprotein B : Apolipoprotein A Ratio After 91 Days (13 Weeks) of Treatment|A decrease from baseline to the end of treatment (i.e. a negative value) in the Apolipoprotein B : Apolipoprotein A ratio indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||ratio||Standard Deviation|Mean
828382|NCT01217112|Secondary|The Change From Baseline in Mean Serum Apolipoprotein B Concentration After 91 Days (13 Weeks) of Treatment|At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum Apolipoprotein B. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||umol/l||Standard Deviation|Mean
828383|NCT01217112|Secondary|The Change From Baseline in Mean Serum Apolipoprotein A Concentration After 91 Days (13 Weeks) of Treatment|At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum Apolipoprotein A. An increase from baseline to the end of treatment, a positive value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||umol/l||Standard Deviation|Mean
828384|NCT01217112|Secondary|The Change From Baseline in Mean Triglyceride Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment|At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of triglyceride concentrations by ultracentrifugation. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||mmol/l||Standard Deviation|Mean
828385|NCT01217112|Secondary|The Change From Baseline in Mean Serum Triglyceride Concentration After 91 Days (13 Weeks) of Treatment|At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum triglyceride concentrations. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||mmol/l||Standard Deviation|Mean
829109|NCT01216410|Secondary|Maternal Hemodynamics|The number of patients with systolic blood pressure decrease to less than 20 % of baseline intraoperatively|Intraoperatively|||participants with SBP< 20 % baseline|||Number
828386|NCT01217112|Secondary|The Change From Baseline in Mean Very Low Density Lipoprotein Cholesterol Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment|At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of Very Low Density Lipoprotein cholesterol by ultracentrifugation. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||mmol/l||Standard Deviation|Mean
828387|NCT01217112|Secondary|The Change From Baseline in Mean High Density Lipoprotein : Low Density Lipoprotein Cholesterol Ratio by Ultracentrifugation After 91 Days (13 Weeks) of Treatment|An increase from baseline (i.e. a positive value) to the end of treatment in the High Density Lipoprotein : Low Density Lipoprotein cholesterol ratio indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||ratio||Standard Deviation|Mean
828388|NCT01217112|Secondary|The Change From Baseline in Mean Serum High Density Lipoprotein : Low Density Lipoprotein Cholesterol Ratio After 91 Days (13 Weeks) of Treatment|An increase from baseline (i.e. a positive value) to the end of treatment in the High Density Lipoprotein : Low Density Lipoprotein cholesterol ratio indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||ratio||Standard Deviation|Mean
828389|NCT01217112|Secondary|The Change From Baseline in Mean Low Density Lipoprotein Cholesterol Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment|At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of Low Density Lipoprotein cholesterol by ultracentrifugation. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||mmol/l||Standard Deviation|Mean
828390|NCT01217112|Secondary|The Change From Baseline in Mean Serum Low Density Lipoprotein Cholesterol Concentration After 91 Days (13 Weeks) of Treatment|At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum Low Density Lipoprotein cholesterol. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||mmol/l||Standard Deviation|Mean
828391|NCT01217112|Secondary|The Change From Baseline in Mean Total Cholesterol Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment|At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum total cholesterol by ultracentrifugation. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||mmol/l||Standard Deviation|Mean
828392|NCT01217112|Secondary|The Change From Baseline in Mean Serum Total Cholesterol Concentration After 91 Days (13 Weeks) of Treatment|At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum total cholesterol. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||mmol/l||Standard Deviation|Mean
828393|NCT01217112|Secondary|The Change From Baseline in Mean High Density Lipoprotein Cholesterol Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment|At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of High Density Lipoprotein cholesterol by ultracentrifugation. An increase from baseline to the end of treatment, a positive value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||mmol/l||Standard Deviation|Mean
828394|NCT01217112|Primary|The Change From Baseline in Mean Serum High Density Lipoprotein Cholesterol Concentration After 91 Days (13 Weeks) of Treatment|At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum High Density Lipoprotein cholesterol. An increase from baseline to the end of treatment, a positive value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||mmol/l||Standard Deviation|Mean
828395|NCT01217229|Secondary|Pharmacodynamic Biomarkers|Blood samples for serum CSF-1, IL-34 and biomarkers of Fms inhibiton and Hodgkin Lymphoma activity will be obtained from subjects and analyzed for changes in activity.|1 year||||||
828396|NCT01217229|Secondary|Progression Free Survival|Subjects will be monitored for disease progression with contrast CT/18FDG-PET scans every two cycles. One cycle is 28 days.|1 Year||||||
828397|NCT01217229|Primary|Disease Response Using Cheson Criteria|Subjects will be monitored for response and disease progression with contrast CT/18FDG-PET scans every two cycles. Each cycle is 28 days. Response to treatment as defined by Cheson criteria will be reported via descriptive statistics. Per Cheson Criteria: Complete Response (CR) is disappearance of all evidence of disease; Partial Response (PR) is regression of measurable disease and no new sites (≥50% decrease in sum of product diameters of up to 6 largest dominant masses and splenic/liver nodules), and no increase in size of other nodes/liver/spleen; reduction in target lesions, no growth of non-target or new lesions; Progression is any new lesion or increase by ≥50% of previously involved sites from the nadir.|1 year|By protocol||Response|||Number
828432|NCT01217892|Secondary|Adjusted Percent Change in Body Weight|To compare the percent change from baseline in body weight achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID, and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 16 weeks of double-blind treatment.|Baseline to Week 16|Full Analysis Set, participants with non-missing baseline and Week 16 (LOCF) values||Percent||Standard Error|Least Squares Mean
829110|NCT01216410|Secondary|Satisfaction|1=very satisfied, 2=somewhat satisfied, 3= neither satisfied nor dissatisfied, 4=somewhat dissatisfied, 5= very dissatisfied. Number of very satisfied subjects posted.|24 h|||participants|||Number
828398|NCT01217411|Primary|Response Rate (Complete or Partial Response) (Phase II)|Only participants with measurable disease present at baseline, received at least 6 weeks of therapy, and had disease re-evaluated considered evaluable for response. Complete Response (CR): Disappearance all lesions; Partial Response (PR): =/>50% decrease in sum bidimensional products all lesions reference baseline sum of bidimensional products of all lesions; Progressive Disease (PD): >25% increase in sum bidimensional products of lesions, or progression of any treated lesion not target lesion, or appearance of 1 or > new lesions at least 6 mm in unidimensional size. Stable Disease (SD): Neither sufficient shrinkage for PR nor increase for PD, reference smallest sum of bidimensional products of all lesions.|12 weeks||||||
828399|NCT01217411|Primary|MTD of RO4929097 in Combination With Stereotactic Surgery (SRS)|MTD of RO4929097 in combination with SRS, determined according to incidence of DLT graded using the NCI CTCAE version 4.0 (phase I)|4 weeks|Analysis was not available due to small number of patients on the study.|||||
828400|NCT01217411|Primary|Maximum-tolerated Dose (MTD) of RO4929097 in Combination With Whole-brain Radiotherapy (WBRT)|Maximum-tolerated dose (MTD) of RO4929097 in combination with WBRT, determined according to incidence of dose limiting toxicity (DLT) graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase I)|4 weeks|Analysis was not available due to small number of patients on the study.|||||
828401|NCT01217463|Secondary|Relative Wound Area Regression of 40% or More at 6 Week|The incidence of wound area regression of at least 40% at week 6 was considered as an important exploratory secondary efficacy variable. The wound area regression was calculated as percentage change from inclusion at week 6 using centralized wound area data.|6 weeks|The analysis of the efficacy criteria was conducted on the ITT population.||percentage of participants|||Number
828402|NCT01217463|Primary|Wound Closure Rate of Diabetic Foot Ulcers (DFUs) of Neuropathic Topical Daily Application of Trafermin 0.01% Spray Compared With Placebo, in Addition|Wound closure is defined as 100% reepithelialization of the target DFU, without exudate.|12 weeks|The primary analysis of the efficacy criteria was conducted on the ITT population.||percentage of participants|||Number
828403|NCT01217476|Secondary|Relative Wound Area Regression of 40% or More at 6 Week|The incidence of wound area regression of at least 40% at week 6 was considered as an important exploratory secondary efficacy variable. The wound area regression was calculated as percentage change from inclusion at week 6 using centralized wound area data.|6 weeks|The analysis of the efficacy criteria was conducted on the ITT population.||percentage of participants|||Number
828404|NCT01217476|Primary|Wound Closure Rate of Diabetic Foot Ulcers (DFUs) of Neuropathic Origin After a Maximum of 12 Weeks Topical Daily Application of Trafermin 0.01% Spray Compared With Placebo, in Addition to Best Local Cares|wound closure is defined as 100% reepithelialization of the target DFU, without exudates.|12 weeks|The primary analysis of the efficacy criteria was conducted on the ITT population.||percentage of participants|||Number
828405|NCT01217515|Secondary|Assessment of Adverse Events, Clinical Laboratory Results, Vital Signs and Sensitivity Reactions|Number of subjects with adverse events, abnormal clinical laboratory results, vital signs and occurrence of any local sensitivity reactions. Data are presented where the incidence is greater than or equal to 5%.|8 weeks|||percentage of participants|||Number
828406|NCT01217515|Secondary|Patient's Global Impression of Improvement (PGI-I)|Compared to the way you felt prior to starting the study treatment, how would you now describe your problems related to the anal fissure?” Responses will be measured on a 7-point Likert scale where 1 = substantially worse, 2 = moderately worse, 3 = slightly worse, 4 = no change, 5 = slightly improved, 6 = moderately improved, and 7 = substantially improved. Percentage of subjects scoring 5,6 or 7 was assessed.|4 weeks|||percentage of participants|||Number
828407|NCT01217515|Primary|Change From Baseline in Average of Worst Anal Pain Associated With or Following Defaecation for Week 4 (for the 7 Treatment Days Immediately Preceding the Week 4 Visit).|Change from baseline in average of worst anal pain associated with or following defaecation for Week 4 (for the 7 treatment days immediately preceding the Week 4 visit). Numerical Rating Scale, range 0-10 where 0 = no pain and 10 = worst pain imaginable.|4 weeks|||units on a scale||Standard Error|Mean
828408|NCT01217606|Secondary|Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) Analyzed by Analysis of Covariance (ANCOVA)|Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. IOP is evaluated at Hour 0 and Hour 2 in the worse eye, defined as the eye with the worse (higher) IOP at baseline. The mean of Hours 0 and 2 is calculated at Baseline and Week 12 in the worse eye. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening). Data are analyzed by ANCOVA.|Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Month 6, Month 9, Month 12|Modified Intent to Treat: all randomized patients with at least one post-baseline efficacy evaluation||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
828409|NCT01217606|Secondary|Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) Analyzed by Mixed-Effect Model for Repeated Measure|Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. IOP is evaluated at Hour 0 and Hour 2 in the worse eye, defined as the eye with the worse (higher) Hour 0 IOP at baseline. The mean of Hours 0 and 2 is calculated at Baseline and Week 12 in the worse eye. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening). Data are analyzed by a mixed-effect model for repeated measure.|Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Month 6, Month 9, Month 12|Modified Intent to Treat: all randomized patients with at least one post-baseline efficacy evaluation and who have data at the noted time point (no missing imputation)||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
828410|NCT01217606|Primary|Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) Analyzed by Two-Sample T-Test|Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. IOP is evaluated at Hour 0 and Hour 2 in the worse eye, defined as the eye with the worse (higher) Hour 0 IOP at baseline. The mean of Hours 0 and 2 is calculated at Baseline and Week 12 in the worse eye. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening). Data are analyzed using a two-sample t-test.|Baseline, Week 12|Modified Intent to Treat: all randomized patients with at least one post-baseline efficacy evaluation||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
828411|NCT01217749|Primary|Safety During Dose-Limiting Toxicity (DLT) Observation Period|Number of dose-limiting toxicities observed in the first 6 participants enrolled in treatment Groups 1 and 2|56 days for Group 1 and 28 days for Group 2|||participants who experienced DLT|||Number
828412|NCT01217749|Secondary|Progression Free Survival (PFS) at 12 Months|"Progressive disease for CLL (Hallek) is characterized by ≥1 of the following:
Appearance of any new lesion, eg lymph nodes (> 1.5 cm), de novo hepatomegaly or splenomegaly, or other organ infiltrates
Increase of ≥50%
in longest diameter of any previous site
in hepatomegaly or splenomegaly
in blood lymphocytes with ≥5x109/L B cells with enlarging lymph node, liver, or spleen
Progressive disease for B cell lymphoma (Cheson) is characterized by any new lesion or increase by ≥ 50% of previously involved sites from nadir:
Appearance of a new lesion(s) >1.5 cm in any axis, ≥ 50% increase in the SPD of >1 node, or ≥50% increase in longest diameter of a previously identified node >1 cm in short axis
Lesions PET+ if FDG-avid lymphoma or PET+ before therapy
50% increase from nadir in the SPD of any liver or spleen lesions
New or recurrent BM involvement
Increase of ≥50% in blood lymphocytes with ≥5x109/L B cells within enlarging lymph node, liver, or spleen"|From first dose of study treatment until disease progression, death, or until 12 months|||percentage of event free participants||95% Confidence Interval|Mean
828413|NCT01217749|Secondary|Number of Participants With Treatment Emergent Adverse Events (AEs)|Number of participants who had experienced at least one treatment emergent AE|From first dose of study treatment to within 30 days of last dose or until study closure|||participants|||Number
828414|NCT01217749|Primary|Percentage of Participants Achieving Response|The primary endpoint for the study was overall response rate (ORR), defined as the proportion of participants who achieved a best overall response of complete response (CR), CR with incomplete blood count recovery (Cri), or partial response (PR), according to the guidelines from the International Workshop on Chronic Lymphocytic Leukemia (IWCLL1) published in 2008 for CLL participants and International Working Group for non-Hodgkin’s lymphoma (IWG NHL) 2007 criteria for SLL participants, with the modification that treatment-related lymphocytosis will not be considered progressive disease, as evaluated by the investigators. Assessment of disease is based on radiological exams, physical exam, hematological evaluations and, when appropriate, bone marrow results.|The median follow-up time on study for all treated participants is 12.5 (range 0.5-19.6) months|||percentage of participants||95% Confidence Interval|Number
828415|NCT01217801|Primary|Area Under Plasma Concentration|Calculation of the AUC-Time Curve will be conducted to determine bio-equivalence.|Day 1 and Day 7|All that completed a period||ng*hr/ml||Standard Deviation|Mean
828416|NCT01217814|Secondary|Pharmacokinetic (PK) Parameter: Serum Concentration of Functional and Bound Sarilumab||Week 12|Analysis was performed in PK population of all participants with at least one non-missing serum concentration data.||ng/mL||Standard Deviation|Mean
828417|NCT01217814|Secondary|Percentage of Participants Achieving DAS28 Remission Score < 2.6 at Week 12||Week 12|As the number of participants randomized fell well below target (16 vs. 250), the efficacy data were not systematically collected or cleaned and no datasets have been created to report.|||||
828418|NCT01217814|Secondary|European League Against Rheumatism (EULAR) Response at Week 12||Week 12|As the number of participants randomized fell well below target (16 vs. 250), the efficacy data were not systematically collected or cleaned and no datasets have been created to report.|||||
828419|NCT01217814|Secondary|Disease Activity Score for 28 Joints (DAS28) at Week 12||Week 12|As the number of participants randomized fell well below target (16 vs. 250), the efficacy data were not systematically collected or cleaned and no datasets have been created to report.|||||
828420|NCT01217814|Secondary|Percentage of Participants Who Achieved at Least 70% Improvement in American College of Rheumatology Core (ACR70) Set Disease Activity Index at Week 12||Week 12|As the number of participants randomized fell well below target (16 vs. 250), the efficacy data were not systematically collected or cleaned and no datasets have been created to report.|||||
828421|NCT01217814|Secondary|Percentage of Participants Who Achieved at Least 50% Improvement in American College of Rheumatology (ACR50) Core Set Disease Activity Index at Week 12||Week 12|As the number of participants randomized fell well below target (16 vs. 250), the efficacy data were not systematically collected or cleaned and no datasets have been created to report.|||||
828422|NCT01217814|Primary|Percentage of Participants Who Achieved at Least 20% Improvement in American College of Rheumatology (ACR20) Core Set Disease Activity Index at Week 12||Week 12|As the number of participants randomized fell well below target (16 vs. 250), the efficacy data were not systematically collected or cleaned and no datasets have been created to report.|||||
828423|NCT01217827|Primary|Referral for Implantable Cardioverter Defibrillator||6 months|||participants|||Number
828424|NCT01217840|Secondary|Inflammatory Cytokines||6 months||||||
828425|NCT01217840|Secondary|Blood Pressure||6 months||||||
828426|NCT01217840|Secondary|Glucose Metabolism||6 months||||||
828427|NCT01217840|Secondary|Lipid Profile||6 months||||||
828428|NCT01217840|Primary|25OH Vitamin D||6 months|||ng/mL||Standard Error|Mean
828429|NCT01217892|Secondary|Proportion of Participants With HbA1c<7.0% at Week 16, in Participants Who Had HbA1c ≥7.0% at Baseline.|To compare the adjusted proportions controlling for baseline HbA1c [acc. to Zhang, Tsiatis & Davidian and Davidian, Tsiatis, Zhang & Lu] of participants with HbA1c <7.0% achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 16 weeks of double-blind treatment, in patients who had HbA1c ≥7.0% at baseline.|Baseline to Week 16|Full Analysis Set, participants with non-missing baseline and Week 16 (LOCF) values||Percentage of participants||95% Confidence Interval|Least Squares Mean
828430|NCT01217892|Secondary|Adjusted Mean Change in Fasting Plasma Glucose (FPG) From Baseline to Week 16|To compare the change from baseline in fasting plasma glucose (FPG) achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 16 weeks of double-blind treatment.|Baseline to Week 16|Full Analysis Set, participants with non-missing baseline and Week 16 (LOCF) values||mg/dL||Standard Error|Least Squares Mean
828431|NCT01217892|Secondary|Adjusted Mean Change in Fasting Plasma Glucose (FPG) From Baseline to Week 1|To compare the change from baseline in fasting plasma glucose (FPG) achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 1 week of double-blind treatment.|Baseline to Week 1|Full Analysis Set, participants with non-missing baseline and Week 1 values||mg/dL||Standard Error|Least Squares Mean
829111|NCT01216410|Secondary|Pruritus||0-24 hrs|||participants|||Number
829112|NCT01216410|Secondary|Postoperative Nausea and Vomiting (PONV)||0-2h, 2-6h, 6-24h|||participants|||Number
828433|NCT01217892|Primary|Adjusted Mean Change in HbA1c Levels|To compare the change from baseline in HbA1c achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 16 weeks of double-blind treatment.|Baseline to Week 16|Full Analysis Set, participants with non-missing baseline and Week 16 (LOCF) values||Percent||Standard Error|Least Squares Mean
828434|NCT01217944|Secondary|Number of Ranibizumab Injections Received by Patients Randomized to vPDT With Ranibizumab From Month 3 by Period|Number of ranibizumab injections received by patients randomized to the vPDT with ranibizumab groups, by period.|Month 3 up to month 12|The Safety Set consisted of all patients who received at least one application of study treatment (ranibizumab [sham] and/or vPDT [sham]) and had at least one post-baseline safety assessment.||injections||Standard Deviation|Mean
828435|NCT01217944|Secondary|Number of Ranibizumab Injections Received by Patients Randomized to the Ranibizumab Groups, by Period|Number of ranibizumab injections received by patients randomized to the ranibizumab groups, by period|Day 1 prior to month 6 and prior to month 12|The Safety Set consisted of all patients who received at least one application of study treatment (ranibizumab [sham] and/or vPDT [sham]) and had at least one post-baseline safety assessment||injections||Standard Deviation|Mean
828436|NCT01217944|Secondary|Number of Ranibizumab Injections Received Prior to Month 3|In order to describe exposure to the study drug the number of ejections was evaluated|Day 1 and prior to month 3|The Safety Set consisted of all patients who received at least one application of study treatment (ranibizumab [sham] and/or vPDT [sham]) and had at least one post-baseline safety assessment||injections||Standard Deviation|Mean
828437|NCT01217944|Secondary|Percentage of Patients With Choroidal Neovascularization (CNV) Leakage in the Study Eye|CNV leakage assessment plus other choroid and retinal disorders were assessed by Central Reading Center using patient’s fluorescein angiography and color fundus photography images provided by investigators.|Baseline and Month 12|Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward||Percentage of Patients|||Number
828438|NCT01217944|Secondary|Change From Baseline in Central Retinal Thickness of the Study Eye Over Time|Retinal thickness was measured by Central Reading Center using patient’s Optical Coherence Tomography (OCT) images provided by investigators.|Baseline, Month 3, Month 6 and Month 12|Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward||Microns||Standard Deviation|Mean
828439|NCT01217944|Secondary|Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letter Loss at Month 6 and 12|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. A decreased score indicates worsening in acuity. This outcome assessed the percentage of participants who lost more than 10 or more than 15 of visual acuity at month 6 and 12.|Months 6 and 12|Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward||Percentage of Patients|||Number
828440|NCT01217944|Secondary|Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letter Loss at Month 3|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. A decreased score indicates worsening in acuity. This outcome assessed the percentage of participants who lost more than 10 or more than 15 of visual acuity at month 3.|Month 3|Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward||Percentage of Patients|||Number
828441|NCT01217944|Secondary|Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letters Gain or Reach 84 Letters at Month 6 and Month 12|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained more than 10 or more than 15 letters of visual acuity at month 6 and month 12.|Months 6 and 12|Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward||Percentage of Patients|||Number
828442|NCT01217944|Secondary|Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letters Gain or Reach 84 Letters at Month 3|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained more than 10 or more than 15 of visual acuity at month 3.|Month 3|Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward||Percentage of Patients|||Number
828443|NCT01217944|Secondary|Average Change From Baseline to Month 1 Through Month 12 in Visual Acuity of the Study Eye|The Best Corrected Visual Acuity (BCVA) was tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts at baseline and Month 1 through 12|Baseline and Month 1 through Month 12|Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward||Letters||Standard Deviation|Mean
828444|NCT01217944|Secondary|Average Change From Baseline to Month 6 in Visual Acuity of the Study Eye|The Best Corrected Visual Acuity (BCVA) was tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts at baseline and month 6. The overall BCVA score was calculated using the BCVA worksheet.|Baseline and Month 6|Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward||Letters||Standard Deviation|Mean
828445|NCT01217944|Primary|Average Change From Baseline to Month 1 Through Month 3 on Visual Acuity of the Study Eye|The Best Corrected Visual Acuity (BCVA) was tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts at baseline and compared to the average from month 1 to month 3.|Baseline, Month 1 through Month 3|Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward||Letters||Standard Deviation|Mean
828446|NCT01217957|Secondary|Phase 2: 1 Year Survival Rate|1-year survival rate is defined as the percentage of participants still alive at year after the first dose of stud drug.|1 year after first dose of study drug|||percentage of participants||95% Confidence Interval|Number
828447|NCT01217957|Secondary|Phase 2: Progression Free Survival (PFS)|PFS was measured as the time in months from the first dose of study treatment to the date of the first documented PD or death.|Up to 787 days|The mITT population was defined as all patients who received at least one dose of any study drug in phase 2 or who received at least one dose of any study drug and were treated at the phase 2 dose level during phase 1.||months||95% Confidence Interval|Median
828448|NCT01217957|Secondary|Phase 2: Duration of Response (DOR)|DOR was measured as the time in months from the date of first documentation of a confirmed response (CR + PR+ VGPR) to the date of the first documented disease progression (PD). Response was assessed by the investigator using International Myeloma Working Group (IMWG) Criteria. CR=negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow. VGPR=Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level < 100 mg per 24 hours.|Up to 787 days|Participants from the Response Evaluable Population, defined as all patients who received at least one dose of ixazomib, had measurable disease at baseline, and at least one post-baseline disease assessment, with data available for analysis. Patients who did not experience PD were censored at the last response assessment that was SD or better.||months||95% Confidence Interval|Median
828449|NCT01217957|Secondary|Phase 2: Time to Best Response|Time to Best Response was measured as the time in months from the first dose of study treatment to the date of first documented documentation of a confirmed response of partial response (PR) or better.|Up to 787 days|Participants form the response-evaluable population, defined as all patients who received at least one dose of ixazomib, had measurable disease at baseline, and at least one post-baseline disease assessment, with available data.||months||Full Range|Median
828450|NCT01217957|Secondary|Phase 2: Percentage of Participants With Complete Response (CR), Stringent Complete Response (sCR), Very Good Partial Response (VGPR), Near Complete Response (nCR), Partial Response (PR) and Minimal Response (MR)|Response was assessed by the investigator using International Myeloma Working Group (IMWG) Criteria. CR=Negative immunofixation on the serum and urine + Disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow. sCR= CR + Normal free light chain (FLC) ratio and Absence of clonal cells in bone marrow. PR=≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to < 200 mg per 24 hours. VGPR= Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level < 100 mg per 24 hours. nCR=Positive immunofixation analysis of serum or urine as the only evidence of disease. Disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow. MR=25% to 49% reduction in serum paraprotein and 50% to 89% reduction in urine light chain excretion for 6 weeks.|Cycles 3, 6, 9 and 12 (Up to 787 days)|The response-evaluable population was defined as all patients who received at least one dose of ixazomib, had measurable disease at baseline, and at least one post-baseline disease assessment.||percentage of participants||95% Confidence Interval|Number
828451|NCT01217957|Secondary|Phase 2: Percentage of Participants With Complete Response (CR) and Very Good Partial Response (VGPR)|Response was assessed by the investigator using International Myeloma Working Group (IMWG) Criteria. CR is defined as negative immunofixation on the serum and urine and; disappearance of any soft tissue plasmacytomas and; < 5% plasma cells in bone marrow. VGPR is defined as Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level < 100 mg per 24 hours.|After Cycles 3, 6 and 9 (Up to 787 days)|The response-evaluable population was defined as all patients who received at least one dose of ixazomib, had measurable disease at baseline, and at least one post-baseline disease assessment.||percentage of participants||95% Confidence Interval|Number
828452|NCT01217957|Secondary|Phase 2: Overall Response Rate (ORR)|ORR was defined as the percentage of participants with CR, VGPR and Partial Response (PR) assessed by the investigator using IMWG criteria. CR=Negative immunofixation on the serum and urine + Disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow. PR=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by 90% or to < 200 mg per 24 hours. VGPR= Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level < 100 mg per 24 hours.|Up to 787 days|The response-evaluable population was defined as all patients who received at least one dose of ixazomib, had measurable disease at baseline, and at least one post-baseline disease assessment.||percentage of participants||95% Confidence Interval|Number
828453|NCT01217957|Secondary|Phase 2: Overall Survival (OS)|OS was measured as the time in months from the first dose of study treatment to the date of death + 1 day.|From the first dose of study treatment to the date of death (up to 787 days)|Safety Population included al participants who received 1 of the 3 study drugs. Participants who did not die were censored at the last study visit.||participants||95% Confidence Interval|Median
828454|NCT01217957|Secondary|Phase 2: Time to Progression (TTP)|TTP was measured as the time in months from the first dose of study treatment to the date of the first documented progressive disease (PD).|From the first dose of study treatment to the date of first documented progressive disease (Up to 787 days)|The modified Intent-to-Treat (mITT) population was defined as all patients who received at least one dose of any study drug in phase 2 or who received at least one dose of any study drug and were treated at the phase 2 dose level during phase 1.||months||95% Confidence Interval|Median
828478|NCT01218243|Secondary|Change of International Prostate Symptom Score (IPSS) at the 18th Week|International Prostate Symptom Score (IPSS) Range:0-35(0 is best，35 is worst, ordinal),18 week mean minus baseline mean.|baseline and the 18th week|The data analysis of the secondary outcome was based on the ITT population.||units on a scale||Standard Deviation|Mean
828455|NCT01217957|Secondary|Phase 1: TEmax: Time to the Maximum Observed Inhibition of Whole Blood 20S Proteasome|TEmax is the time to the maximum observed inhibition of whole blood 20S proteasome. The pharmacodynamics 20S Proteasome samples were collected and the assays were performed; however, concerns about the third-party laboratory’s performance of the blood 20S proteasome activity assay were identified that precluded the ability to confirm the accuracy of the data so no data is reported.|Day 1 predose and at multiple time points (up to 168 hours) postdose and Day 15 predose and at multiple time points (up to 336 hours) postdose||||||
828456|NCT01217957|Secondary|Phase 1: Emax: Maximum Observed Inhibition of Whole Blood 20S Proteasome|Emax is the maximum observed inhibition of whole blood 20S proteasome. The pharmacodynamics 20S Proteasome samples were collected and the assays were performed; however, concerns about the third-party laboratory’s performance of the blood 20S proteasome activity assay were identified that precluded the ability to confirm the accuracy of the data so no data is reported.|Day 1 predose and at multiple time points (up to 168 hours) postdose and Day 15 predose and at multiple time points (up to 336 hours) postdose||||||
828457|NCT01217957|Secondary|Phase 1: Rac: Accumulation Ratio of Ixazomib|The accumulation ratio (Rac) was estimated as the ratio of AUC(0-168) on Day 15 to the AUC(0-168) on Day 1. AUC(0-168) is the area under the plasma concentration-time curve from time 0 to 168 hours postdose for ixazomib.|Cycle 1, Day 15|The Pharmacokinetic (PK) analysis population, defined as all patients enrolled in the phase 1 portion of the study who had sufficient dosing data and ixazomib concentration-time data to permit calculation of ixazomib pharmacokinetic parameters, with available data.||Ratio||Standard Deviation|Geometric Mean
828458|NCT01217957|Secondary|Phase 1: AUC(0-168): Area Under the Plasma Concentration-Time Curve From Time 0 to 168 Hours Postdose for Ixazomib|AUC(0-168) is a measure of the area under the plasma concentration-time curve from time 0 to 168 hours postdose for Ixazomib.|Cycle 1, Days 1 and 15|The Pharmacokinetic (PK) analysis population, defined as all patients enrolled in the phase 1 portion of the study who had sufficient dosing data and ixazomib concentration-time data to permit calculation of ixazomib pharmacokinetic parameters, with available data.||hr*ng/mL||Standard Deviation|Geometric Mean
828459|NCT01217957|Secondary|Phase 1: Tmax: Time to Reach the Maximum Observed Plasma Concentration (Cmax) for Ixazomib|Tmax: Time to reach the first maximum observed plasma concentration (Cmax), equal to time (hours) to Cmax, obtained directly from the plasma concentration-time curve.|Cycle 1, Days 1 and 15|The Pharmacokinetic (PK) analysis population, defined as all patients enrolled in the phase 1 portion of the study who had sufficient dosing data and ixazomib concentration-time data to permit calculation of ixazomib pharmacokinetic parameters, with data available.||hours||Full Range|Median
828460|NCT01217957|Secondary|Phase 1: Cmax: Maximum Observed Plasma Concentration for Ixazomib|Cmax: Maximum Observed Plasma Concentration (Cmax) is the peak plasma concentration of ixazomib obtained directly from the plasma concentration-time curve.|Cycle 1, Days 1 and 15|The Pharmacokinetic (PK) analysis population, defined as all patients enrolled in the phase 1 portion of the study who had sufficient dosing data and ixazomib concentration-time data to permit calculation of ixazomib pharmacokinetic parameters, with available data.||ng/mL||Standard Deviation|Geometric Mean
828461|NCT01217957|Primary|Phase 2: Percentage of Participants With Grade 3 or Higher AEs, SAEs and Treatment Discontinuation|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event.|Until occurrence of progressive disease or unacceptable toxicity (Up to 787 days)|The safety population was defined as all patients who received at least one dose of any of the 3 study drugs.||percentage of participants|||Number
828462|NCT01217957|Primary|Phase 1: Maximum Tolerated Dose (MTD) of Ixazomib Administered Weekly in Combination With Lenalidomide and Low-Dose Dexamethasone|MTD of ixazomib will be determined by assessing adverse events and serious adverse events, clinical laboratory values, neurotoxicity grading, and vital sign measurements.|Until occurrence of progressive disease or unacceptable toxicity (Up to 336 days)|All Phase 1 participants.||mg/m^2|||Number
828463|NCT01217957|Primary|Phase 1: Recommended Phase 2 Dose of Ixazomib Given in Combination With Lenalidomide and Low-Dose Dexamethasone|RP2D will be determined based on number and type of adverse event and serious adverse events, assessments of clinical laboratory values, neurotoxicity grading, and treatment discontinuation.|Until occurrence of progressive disease or unacceptable toxicity (Up to 336 days)|All Phase 1 participants.||mg/m^2|||Number
828464|NCT01217957|Primary|Phase 2: Objective Response Rate (ORR) Following Treatment With the Combination Of Oral Ixazomib, Lenalidomide And Low-Dose Dexamethasone|ORR was defined as the percentage of participants with Complete (CR) + Very Good Partial Response (VGPR) assessed by the investigatory using International Myeloma Working Group (IMWG) Criteria. CR=Negative immunofixation on the serum and urine and; disappearance of any soft tissue plasmacytomas and; < 5% plasma cells in bone marrow. VGPR=Serum and urine M-protein detectable by immunofixation but not on electrophoresis or; 90% or greater reduction in serum M-protein plus urine M-protein level < 100 mg per 24 hours.|Until occurrence of progressive disease or unacceptable toxicity (Up to 787 days)|Participants from the response-evaluable population, defined as all patients who received at least one dose of ixazomib, had measurable disease at baseline, and at least one post-baseline disease assessment, with available data.||percentage of participants||95% Confidence Interval|Number
828479|NCT01218243|Secondary|Change of Maximum Urinary Flow Rate(Qmax)at the 6th Week|Maximum urinary flow rate was used to assess the bladder function, 6 week mean minus baseline mean|baseline and the 6th week|The data analysis of the secondary outcome was based on the ITT population.||ml/second||Standard Deviation|Mean
828480|NCT01218243|Secondary|Change of Bladder Residual Urine at the 6th Week|Bladder residual urine was used to assess the bladder function, 6 week mean minus baseline mean|baseline and the 6th week|The data analysis of the secondary outcome was based on the ITT population.||ml||Full Range|Median
829113|NCT01216410|Primary|Intraoperative Nausea and Vomiting|Comparison of intraoperative nausea and vomiting between the 3 groups.|Intraoperatively|||participants|||Number
828465|NCT01217957|Primary|Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event.|Until occurrence of progressive disease or unacceptable toxicity (Up to 336 days)|The safety population was defined as all patients who received at least one dose of any of the 3 study drugs.||participants|||Number
828466|NCT01218009|Post-Hoc|Pulse at Screening and End of Study|Vital sign measurements (heart rate and blood pressure) were evaluated as part of the safety profile assessment. The participant was seated at least 2 minutes before vital signs were performed. Heart rate was measured by radial pulse.|Days -15 to -8 (Screening), up to Day 49 (End of study)|Safety population||beats/minute||Standard Deviation|Mean
828467|NCT01218009|Post-Hoc|Blood Pressure at Screening and End of Study|Vital sign measurements (heart rate and blood pressure) were evaluated as part of the safety profile assessment. The participant was seated at least 2 minutes before vital signs were performed. Either an electronic or manual sphygmomanometer was used.|Days -15 to -8 (Screening), up to Day 49 (End of study)|Safety population||mmHg||Standard Deviation|Mean
828468|NCT01218009|Primary|Changes From Screening in the Vital Signs That Are Clinically Significant in the Opinion of the Investigator|Vital sign measurements (heart rate and blood pressure) were to be evaluated as part of the safety profile assessment. The participant was to be seated at least 2 minutes before vital signs were performed. Either an electronic or manual sphygmomanometer could be used.|Days -15 to -8 (Screening), Week 12, Week 52|Safety population. The study was terminated prior to the during study evaluations.|||||
828469|NCT01218009|Primary|Changes From Screening in the Results of the Electrocardiograms (ECGs) That Are Clinically Significant in the Opinion of the Investigator|A standard 12-lead ECG was to be performed at screening and at week 12 and week 52 (TV15) or early termination/discontinuation of the participant. The ECG recording methods were to be centralized and standardized across all study subjects.|Days -15 to -8 (Screening), Week 12, Week 52|Safety population. The study was terminated prior to the during study evaluations.|||||
828470|NCT01218009|Primary|Changes From Screening in the Results of the Laboratory Evaluations That Are Clinically Significant in the Opinion of the Investigator|Blood samples were to collected for laboratory evaluations at the screening visit and at weeks 12 and 52 or early termination/discontinuation of the participant. The blood samples were to be drawn after an overnight fast of at least 6 hours and analyzed by a central laboratory.|Days -15 to -8 (Screening), Week 12, Week 52|Safety population. The study was terminated prior to the during study evaluations.|||||
828471|NCT01218009|Primary|Changes From Screening in the Results of the Physical Examination That Are Clinically Significant in the Opinion of the Investigator|A complete physical examination was planned at study screening, week 12 and week 52 or early termination/discontinuation of the participant. At weeks 12 and 52,the qualified healthcare professional was to evaluate whether each physical finding is a new finding, worsening, improvement or resolution of an existing condition compared with the baseline physical exam. Where possible, the same qualified healthcare professional that performed the physical examination at study screening should perform all the scheduled physical examinations.|Days -15 to -8 (Screening), Week 12, Week 52|Safety population. The study was terminated prior to the during study evaluations.|||||
828472|NCT01218009|Primary|Participants With Treatment-Emergent Adverse Events|Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 to Day 49 (study termination)|Safety population||participants|||Number
828473|NCT01218087|Secondary|Incidence of Cardiorespiratory|daily log of cardiorespiratory events (apnea, bradycardia, oxygen desaturation) collected on a daily positioning log at the infant's bedside|daily up to 120 days|||cardioresp. events/100hrs of device use|||Number
828474|NCT01218087|Primary|Cranial Abnormalities Were Measured at Hospital Discharge|Cranial abnormality measurements were obtained at hospital discharge by orthotists blinded to the study group assignment. Cranial abnormalities include both cranial index measures and cranial symmetry measures. Cranial index (normal measurement between 73%-85%) was obtained dividing the head width (M-L) by length (A-P) then multiplying it by 100%. Cranial symmetry (normal measurement of<8mm) was obtained by calculating the difference in the right and left anterior-posterior measures.|up to 120 days|||% participant cranial abnormalities|||Number
828475|NCT01218100|Secondary|The Change From Baseline in Trough Seated Systolic Blood Pressure at Week 6.||Visit 6/(Week 0) and Visit 9/(Week 6)|||mm HG||Standard Deviation|Mean
828476|NCT01218100|Primary|The Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 6.||Visit 6/(Week 0) and Visit 9/(Week 6)|||mm HG||Standard Deviation|Mean
828477|NCT01218243|Primary|Change of International Prostate Symptom Score(IPSS) at the 6th Week Compared With Baseline(Per-protocol).|International Prostate Symptom Score (IPSS) Range:0-35(0 is best，35 is worst, ordinal),6 week mean minus baseline mean. And analysis for this outcome measure is based on per-protocol population.|baseline and the 6th week|The data analysis of the primary outcome is also based on per-protocol (PP) population as a supportive analysis.||units on a scale||Standard Deviation|Mean
829114|NCT01216631|Secondary|Rheumatoid Arthritis Outcome Score (RAOS)|Change in RAOS questionnaire score|26 weeks||||||
829115|NCT01216631|Secondary|Rheumatoid Arthritis Outcome Score (RAOS)|Change in RAOS questionnaire score|16 weeks||||||
828481|NCT01218243|Primary|Change of IPSS at the 6th Week Compared With Baseline(Intention to Treat)|International Prostate Symptom Score (IPSS) Range:0-35(0 is best，35 is worst, ordinal),6 week mean minus baseline mean.And analysis for this outcome measure is based on ITT population.|baseline and the 6th week|The data analysis of the primary outcome was based on the ITT population(data of all participants who are randomized will be analyzed).||units on a scale||Standard Deviation|Mean
828482|NCT01218308|Secondary|Number of Subjects With Any and Related Serious Adverse Events (SAEs).|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Any = Any SAE(s) regardless of intensity or relationship to vaccination. Related = SAEs assessed by the investigator as causally related to the vaccination.|During the entire study period (Day 0 - Day 180)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.||subjects|||Number
828483|NCT01218308|Secondary|Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs).|pIMDs were defined as a subset of AEs that included both clearly autoimmune diseases (AID) and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Any = Any pIMD(s) regardless of intensity or relationship to vaccination. Related = pIMDs assessed by the investigator as causally related to the vaccination.|During the entire study period (Day 0 - Day 180)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.||subjects|||Number
828484|NCT01218308|Secondary|Number of Subjects With Any and Related Medically Attended Adverse Events (MAEs).|MAEs were defined as AEs that resulted in medical attention (defined as hospitalization, an emergency room visit or a visit to or from medical personnel for any reason). Any = Any MAE regardless of intensity or relationship to vaccination. Related = MAE assessed by the investigator as causally related to the vaccination.|During the entire study period (Day 0 - Day 180)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.||subjects|||Number
828485|NCT01218308|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = Any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = Unsolicited AE that prevented normal activity. Related = Unsolicited AE assessed by the investigator as causally related to the vaccination.|During the 28-day (Days 0-27) follow-up period after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.||subjects|||Number
828486|NCT01218308|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects of 5 Years of Age and Above.|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (Gastro.), headache, joint pain at other location (Joint pain), muscle aches, shivering and temperature. Any = Occurrence of any solicited general symptom regardless of intensity grade or relation to vaccination. Any temperature = Axillary temperature ≥ 38.0 °C. Grade 3 symptom = Symptom that prevented normal activity. Related = Symptom assessed by the investigator as causally related to the vaccination. Grade 3 temperature = Axillary temperature ≥ 39.0°C.|During the 7-day (Days 0-6) follow-up period after any vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet completed.||subjects|||Number
828487|NCT01218308|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Below 5 Years of Age.|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature. Any = Occurrence of any solicited general symptom regardless of intensity grade and relation to vaccination. Any temperature = Axillary temperature ≥ 38.0 °C. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irritability = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = not eating at all. Related = General symptom assessed by the investigator as causally related to the study vaccination. Grade 3 temperature = Axillary temperature ≥ 39.0°C.|During the 7-day (Days 0-6) follow-up period after any vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet completed.||subjects|||Number
828488|NCT01218308|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.|Assessed solicited local symptoms were pain, redness and swelling at the injection site. Any = Incidence of a particular symptom regardless of intensity grade. Grade 3 pain = Cried when limb was moved/spontaneously painful for subjects < 5 years of age or significant pain at rest that prevented normal, everyday activities for subjects ≥ 5 years of age. Grade 3 redness/swelling = Redness/swelling above 100 millimeters (mm) of the injection site. All solicited local symptoms were considered related to vaccination.|During the 7-day (Days 0-6) follow-up period after any vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet completed.||subjects|||Number
828489|NCT01218308|Secondary|Seroconversion Factors for HI Antibodies Against 4 Strains of Influenza Disease.|Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The 4 influenza strains assessed were the Flu A/California/7/09 (H1N1), Flu A/Victoria/210/09 (H3N2), FluB/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).|At least 6 months after first vaccination (Month 6)|The ATP Cohort for persistence included, in terms of antibody response measured by the HI assay, all evaluable subjects for whom data concerning immunogenicity outcome measure were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Fold increase||95% Confidence Interval|Geometric Mean
828490|NCT01218308|Secondary|Number of Seroprotected Subjects for HI Antibody Titers Against Each of the 4 Vaccine Influenza Strains.|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/California/7/09 (H1N1), Flu A/Victoria/210/09 (H3N2), FluB/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).|At Day 0 and at least 6 months after first vaccination (Month 6)|The ATP Cohort for persistence included, in terms of antibody response measured by the HI assay, all evaluable subjects for whom data concerning immunogenicity outcome measure were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
828491|NCT01218308|Secondary|Number of Seroconverted Subjects for HI Antibody Titers Against Each of the 4 Vaccine Influenza Strains.|A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/California/7/09 (H1N1), Flu A/Victoria/210/09 (H3N2), FluB/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).|At least 6 months after first vaccination (Month 6)|The ATP Cohort for persistence included, in terms of antibody response measured by the HI assay, all evaluable subjects for whom data concerning immunogenicity outcome measure were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
828492|NCT01218308|Secondary|Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Strains|HI antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Victoria/210/09 (H3N2), Flu B/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).|On Day 0 and at least 6 months after first vaccination (Month 6)|The ATP Cohort for persistence included, in terms of antibody response measured by the HI assay, all evaluable subjects for whom data concerning immunogenicity outcome measure were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Titer||95% Confidence Interval|Geometric Mean
828493|NCT01218308|Secondary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 4 influenza strains assessed were the Flu A/California/7/09 (H1N1), Flu A/Victoria/210/09 (H3N2), FluB/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).|At 28 days post vaccination (Day 28 for primed subjects and day 56 for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects (those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measure were available.||fold increase||95% Confidence Interval|Mean
828494|NCT01218308|Secondary|Number of Seroprotected Subjects Against 4 Strains of Influenza Disease.|A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 4 influenza strains assessed were the Flu A/California/7/09 (H1N1), Flu A/Victoria/210/09 (H3N2), FluB/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).|At Day 0 [PRE] and 28 days post vaccination (Day 28 for primed subjects and day 56 for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects (those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measure were available.||subjects|||Number
828495|NCT01218308|Secondary|Number of Seroconverted Subjects Against 4 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer. The 4 influenza strains assessed were the Flu A/California/7/09 (H1N1), Flu A/Victoria/210/09 (H3N2), FluB/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).|At 28 days post vaccination (Day 28 for primed subjects and day 56 for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects (those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measure were available.||subjects|||Number
828496|NCT01218308|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The reference cut-off value was the seropositivity cut-off of 1:10. The 4 influenza strains assessed were the Flu A/California/7/09 (H1N1), Flu A/Victoria/210/09 (H3N2), FluB/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).|At Day 0 [PRE] and 28 days post vaccination (Day 28 for primed subjects and day 56 for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects (those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measure were available.||titers||95% Confidence Interval|Geometric Mean
828497|NCT01218308|Secondary|Number of Subjects Reporting at Least One Culture Confirmed Occurrence of Influenza A or B Due to Any Strain.|To confirm influenza A and/or B disease due to any strain, a positive reverse transcriptase polymerase chain reaction (RT-PCR) result for influenza A or B virus from a nose and throat swab obtained concurrently with an influenza like illness (ILI) was required. ILI was defined as the presence of an oral or axillary temperature ≥ 37.8 degrees Celsius (°C) in the presence of at least one of the following symptoms on the same day: cough, sore throat, runny nose or nasal congestion.|From Day 14 to Day 180|The analysis was performed on the According-To-Protocol cohort for efficacy – Time to event, which included all eligible subjects who met all inclusion criteria and no exclusion criteria, followed their study treatment assignment and were successfully contacted at least once after the first vaccination.||subjects|||Number
828498|NCT01218308|Secondary|Number of Subjects Reporting at Least One Culture Confirmed Occurrence of Influenza A or B Due to Antigenically Matched Strain.|To confirm influenza A and/or B disease due to antigenically matched strain, a positive reverse transcriptase polymerase chain reaction (RT-PCR) result for influenza A or B virus from a nose and throat swab obtained concurrently with an influenza like illness (ILI) was required. ILI was defined as the presence of an oral or axillary temperature ≥ 37.8 degrees Celsius (°C) in the presence of at least one of the following symptoms on the same day: cough, sore throat, runny nose or nasal congestion.|From Day 14 to Day 180|The analysis was performed on the According-To-Protocol cohort for efficacy – Time to event, which included all eligible subjects who met all inclusion criteria and no exclusion criteria, followed their study treatment assignment and were successfully contacted at least once after the first vaccination.||subjects|||Number
829116|NCT01216631|Secondary|Rheumatoid Arthritis Outcome Score (RAOS)|Change in RAOS questionnaire score|14 weeks||||||
829117|NCT01216631|Secondary|Rheumatoid Arthritis Outcome Score (RAOS)|Change in RAOS questionnaire score|8 weeks||||||
828499|NCT01218308|Secondary|Number of Subjects Reporting at Least One Moderate to Severe Occurrence of Influenza A or B.|"To confirm influenza A and/or B disease moderate to severe cases, a positive RT-PCR result for influenza A or B virus from a nose and throat swab obtained concurrently with an ILI was required. Moderate to severe influenza was defined as RT-PCR-confirmed ILI with:
Fever >39°C, and/or at least one of the following manifestations,
Physician-verified shortness of breath, pulmonary congestion, pneumonia, bronchiolitis, bronchitis, wheezing, croup, or acute otitis media, and/or one of the following,
Physician-diagnosed serious extra-pulmonary complication of influenza, including myositis, encephalitis, seizure, or myocarditis"|From Day 14 to Day 180|The analysis was performed on the According-To-Protocol cohort for efficacy – Time to event, which included all eligible subjects who met all inclusion criteria and no exclusion criteria, followed their study treatment assignment and were successfully contacted at least once after the first vaccination.||subjects|||Number
828500|NCT01218308|Primary|Number of Subjects Reporting at Least One Confirmed Occurrence of Influenza A or B.|To confirm influenza A and/or B disease, a positive reverse transcriptase polymerase chain reaction (RT-PCR) result for influenza A or B virus from a nose and throat swab obtained concurrently with an influenza like illness (ILI) was required. ILI was defined as the presence of an oral or axillary temperature ≥ 37.8 degrees Celsius (°C) in the presence of at least one of the following symptoms on the same day: cough, sore throat, runny nose or nasal congestion.|From Day 14 to Day 180|The analysis was performed on the According-To-Protocol cohort for efficacy – Time to event, which included all eligible subjects who met all inclusion criteria and no exclusion criteria, followed their study treatment assignment and were successfully contacted at least once after the first vaccination.||subjects|||Number
828501|NCT01218399|Secondary|Adverse Events|Number of adverse events as per MEDRA terms|1 week|||Number adverse events|||Number
828502|NCT01218399|Primary|Percent Forced Expiratory Volume in One Second (FEV1)|"Asthma symptoms scores reported as measure of FEV1 - Forced Expiratory Volume in one second
FEV1 is given which is a standard outcome in asthma studies and is validated by the NIH (NHLBI)
FEV1 of less than 80 is indicative of severe asthma, 80-90 is moderate asthma, over 90 is mild asthma
http://www.med.umich.edu/1info/FHP/practiceguides/asthma/EPR-3_pocket_guide.pdf"|1 week|||% FEV1||Standard Deviation|Mean
829118|NCT01216631|Secondary|Rheumatoid Arthritis Outcome Score (RAOS)|Change in RAOS questionnaire score|6 weeks||||||
828604|NCT01211873|Secondary|Measure Blood Sample.||up to 24 hours||||||
828605|NCT01211873|Secondary|Injection-site Tolerance on the Visual Analog Scale From 0 (no Pain) to 10 (Maximal Pain).||up to 24 hours||||||
828606|NCT01211873|Secondary|Measure ECG||up to 24 hours||||||
828607|NCT01211873|Secondary|Measure Vital Signs (Supine Systolic and Diastolic Blood Pressures, Pulse).||up to 24 hours||||||
828608|NCT01211873|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability.||up to 29 days||||||
828609|NCT01211873|Secondary|Number of Lesions With MRI Signal Intensity Changes After Contrast Agent Injection.||up to 24 hours as the safety is assessed till 24 hours after injection||||||
828610|NCT01211873|Secondary|Level of Diagnostic Confidence on 5-point Scale Ranging From Nil to Excellent With Poor, Moderate and High as Intermediate Grades.||up to 24 hours as the safety is assessed till 24 hours after injection||||||
829119|NCT01216631|Secondary|Psoriatic Arthritis Quality of Life Scale (PsQOL)|Change in PsQOL score from baseline|26 weeks||||||
828558|NCT01218477|Secondary|Number of Participants With Grade 3-4 Abnormalities on Laboratory Test Results|ALP=alkaline phosphatase; ALT=alanine aminotransferase; AST=aspartate aminotransferase; ULN=upper limit of normal. Abnormalities were graded according to the Common Toxicity Criteria of the National Cancer Institute from 1 (least severe) to 4 (life threatening). ANC (*10^9): Grade 3, <1.0- 0.5; Grade 4, <0.5. Hemoglobin (mmol/L): Grade 3, <4.9-4.0; Grade 4, <4.0. Platelet count (*10^9/L): Grade 3, <50.0-25.0; Grade 4, <25. WBCs (*10^9): Grade 3, <2.0-1.0; Grade 4, <1.0. Hypocalcemia (mmol/L): Grade 3, <1.75-1.5; Grade 4, <1.5. Hyperkalemia (mmol/L): Grade 3, >6.0-7.0; Grade 4, >7.0. Hypokalemia (mmol/L): Grade 3, <3.0-2.5; Grade 4, <2.5. Hyponatremia (mmol/L), Grade 3, <130-120; Grade 4, <120. Hypermagnesemia (mg/dL): Grade 3, >1.23-3.30; Grade 4, >3.30. Phosphorus (mmol/L): Grade 3, <0.6-0.3; Grade 4, <0.3. Lipase (*ULN): Grade 3, >2.0-5.0; Grade 4, >5.0.|Day 1 to Week 80|All participants who received at least 1 dose of study drug.||Participants|||Number
828559|NCT01218477|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs) Leading to Discontinuation, Drug-related AEs Leading to Discontinuation, at Least 1 Drug-related AE, and Dose-limiting Toxicities|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment and may or may not be related to treatment. SAE=an untoward medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=having certain, probable, possible, or missing relationship to study drug. The following drug-related AEs occurring during the first 28 days of treatment with both agents were considered to be dose-limiting toxicities (DLTs): Grade 4 hematologic AE lasting >7 days; ≥Grade 3 nonhematologic AE, despite adequate medical intervention; ≥Grade 2 AE not controlled by medical intervention and requiring treatment interruption for >7 days.|Day 1 to Week 80, continuously, with observation for dose-limiting toxicities (DLTs) in Weeks 5-8|All participants who received at least 1 dose of study drug||Participants|||Number
828560|NCT01218477|Secondary|Percentage of Participants With a Major Hematologic Response (MHR) in Chronic Myeloid Leukemia-Advanced Phase (CML-Adv) and Chronic Myeloid Leukemia-Chronic Phase (CML-CP)|MHR was defined as complete hematologic response (CHR) or no evidence of leukemia (NEL). CHR for CML-Adv criteria: white blood cell count (WBC) ≤upper limit normal; absolute neutrophil count (ANC) ≥1,000/mm^3; platelets ≥100,000/mm^3; no blasts or promyelocytes in peripheral blood (PB); basophils <5% in PB; myelocytes + metamyelocytes < 5% in PB; no extramedullary involvement; blasts must be <5%, if bone marrow assessment (BMA) performed. NEL had same criteria, but with lower thresholds for reconstitution of PB counts, as follows: Platelets ≥ 20,000/mm^3 or ANC >500/mm^3. Confirmed MHR obtained if these criteria met and maintained for ≥28 days. CHR for CML-CP criteria WBC ≤10,000/mm^3; platelets <450,000/mm^3; basophils <5% in PB; no blasts or promyelocytes in PB; myelocytes + metamyelocytes <5% in PB; no extramedullary involvement; blasts must be <5% if BMA performed. Confirmed CHR obtained if these criteria met and maintained for ≥28 days. Nilo=nilotinib; SOR=suboptimal response.|Day 1 to Week 80|Patients without complete hematologic response at dosing start date who received at least 4 weeks of dasatinib and who had at least 1 on-treatment evaluation of both peripheral blood counts and bone marrow cytogenetic response after at least 4 weeks on treatment.||Percentage of participants||95% Confidence Interval|Number
828561|NCT01218477|Secondary|Percentage of Participants With a Major Cytogenetic Response (MCyR) in Chronic Myeloid Leukemia-Advanced Phase (CML-Adv) and Chronic Myeloid Leukemia-Chronic Phase (CML-CP)|Cytogenetic response (CyR) was based on the proportion of Philadelphia chromosome-positive (Ph+) cells in metaphase analysis of bone marrow. Complete cytogenetic response (CCyR)=0 Ph+ cells; Partial CyR (PCyR)=1 to 35 Ph+ cells; Minor CyCR= 36-65 Ph+ cells; Minimal CyCR= 66-95 Ph+ cells; No response= >96 Ph+ cells. MCyR=CCyR + PCyR. Nilo=nilotinib; SOR=suboptimal response.|Day 1 to Week 80|All patients without CCyR at dosing start date who received at least 4 weeks of dasatinib and had at least 1 on-treatment cytogenetic evaluation of the bone marrow data after at least 4 weeks on treatment||Percentage of participants||95% Confidence Interval|Number
828562|NCT01218477|Primary|Recommended Phase 2 Dose (RP2D) of BMS-833923 Plus Dasatinib in Chronic Myeloid Leukemia-Chronic Phase|The following drug-related adverse events (AEs) occurring in the first 28 days of treatment were considered dose-limiting toxicities (DLT): Grade 4 hematologic AE lasting >7 days; ≥Grade 3 nonhematologic AE, despite medical intervention; ≥Grade 2 AE uncontrolled by medical intervention and requiring treatment interruption for >7 days. RP2D was that dose at which ≤1 of 6 patients had a DLT in the first 4 weeks of treatment. If <3 patients were DLT-evaluable, up to 6 additional patients entered the same dose level. Accrual to a dose level closed if 6 patients were enrolled and <3 were DLT-evaluable. If ≥3 patients at a dose level had no DLTs when a new patient enrolled, the dose was escalated to next level. If 1 DLT was observed in <6 patients, ≥6 patients were required; if no additional DLT was observed, the dose was escalated to the next highest level. If ≥2 DLTs were observed in <6 patients, that level exceeded the RP2D, and the dose was deescalated to the next lowest level.|Day 1 to Week 80, with observation for DLT in Weeks 5-8|Participants who were dose-limiting toxicity (DLT)-evaluable (DLT-evaluable=received combination therapy on >21 of 28 days in Weeks 5 through 8 or interrupted treatment for drug-related AEs)||mg|||Number
828563|NCT01218594|Primary|Response Rate (RR)|Tumor response was evaluated with thoracic CT scans when CCRT was completed, in accordance with Response Evaluation Criteria in Solid Tumors Group (RECIST).|4 weeks after CCRT|Response rate (RR)include complete response and partial response.||percentage of participants|||Number
828564|NCT01218646|Other Pre-specified|Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines.|"Solicited injection site reactions: Pain, Erythema and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia.
Grade 3 Injection site reactions: Pain - Significant; prevents daily activity; Erythema and Swelling >100 mm.
Grade 3 solicited systemic reactions: Fever (Temperature) ≥102.1°F; Headache, Malaise, and Myalgia - Significant; prevents daily activity."|Day 0 up to day 21 post-vaccination|Solicited injection site and systemic reactions were assessed in all randomized and vaccinated participants, safety population.||Participants|||Number
828611|NCT01211873|Secondary|The Quality of Images on 3-point Scale: Poor, Fair or Good.||up to 24 hours as the safety is assessed till 24 hours after injection||||||
829120|NCT01216631|Secondary|Psoriatic Arthritis Quality of Life Scale (PsQOL)|Change in PsQOL score from baseline|16 weeks||||||
829121|NCT01216631|Secondary|Psoriatic Arthritis Quality of Life Scale (PsQOL)|Change in PsQOL score from baseline|14 weeks||||||
828565|NCT01218646|Other Pre-specified|Seroconversion Against Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years and Older|"Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.
Seroconversion was defined as either a pre-vaccination HAI titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and ≥ four-fold increase in post-vaccination titer."|Day 21 post-vaccination|Seroconversion to influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population.||Participants|||Number
828566|NCT01218646|Other Pre-specified|Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years or Older.|"Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.
Seroprotection was defined as a pre-vaccination and post-vaccination titer ≥ 1:40 (l/dil)"|Day 21 post-vaccination|Seroprotection to vaccine antigens were determined in randomized and vaccinated participants, per-protocol population||Participants|||Number
828567|NCT01218646|Primary|Geometric Mean Titers Against the Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines (TIV) in Participants Aged 18 Years or Older|Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.|Day 0 and Day 21 post-vaccination|Geometric Mean Titers to the influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population||Titers||95% Confidence Interval|Geometric Mean
828568|NCT01218646|Other Pre-specified|Seroconversion Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines Without Corresponding B Strain in Participants Aged 65 Years and Older.|"Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.
Seroconversion was defined as either a pre-vaccination HAI titer < 1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥ 1:10 and ≥ four-fold increase in post-vaccination titers."|Day 21 post-vaccination|Seroconversion to influenza vaccine B Strains (cross-reactive antibody) was determined in randomized and vaccinated participants, per-protocol population||Participants|||Number
828569|NCT01218646|Primary|Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or After Trivalent Influenza Vaccines Without Corresponding B Strain in Participants Aged 65 Years and Older.|Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.|Day 21 post-vaccination|Geometric Mean Titers to the influenza vaccine B strains (cross-reactive antibody) were determined in randomized and vaccinated participants, per-protocol population||Titers||95% Confidence Interval|Geometric Mean
828570|NCT01218646|Other Pre-specified|Seroconversion Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines (TIV) With Corresponding B Strains in Participants Aged 65 Years and Older.|"Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as < 10.
Seroconversion was defined as either a pre-vaccination HAI titer < 1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and ≥ four-fold increase in post-vaccination titer."|Day 21 post-vaccination|Seroconversion with respect to influenza vaccine B strains (corresponding B strains) was determined in randomized and vaccinated adult participants, per-protocol population||Participants|||Number
828571|NCT01218646|Primary|Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines With Corresponding B Strain in Participants Aged 65 Years and Older.|Immunogenicity outcomes were assessed in serum samples by hemagglutination inhibition (HAI) assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.|Day 21 post-vaccination|Geometric mean titers to the influenza vaccine B antigens were determined in randomized and vaccinated participants, per-protocol population. Data presented for participants with valid serology results for the B antigens, including results reported as less or greater than lower limit of quantitation (<LLOQ or >ULOQ).||Titers||95% Confidence Interval|Geometric Mean
828572|NCT01218802|Primary|Carotid IMT|changes in carotid IMT is a good measure for cardiovascular disease progression|96 weeks|The number of participants who received a final CIMT is less than the number of participants enrolled, due in part to study drop outs and/or invalid data measures.||percentage change||Standard Deviation|Mean
828573|NCT01218802|Primary|Bone Mineral Density (BMD)|Measured by change in bone DEXA from baseline to week 96|96 weeks|The total number of participants who received this outcome who had valid data is less than the total number of enrolled participants, due to drop outs before week 96 and/or invalid testing data from DEXA results.||percentage of change||Standard Deviation|Mean
828574|NCT01218867|Secondary|In Vivo Survival of Chimeric T Cell Receptor (CAR) Gene-engineered Cells|Immunological monitoring using both tetramer analysis and staining for the T cell receptor (TCR) will be used to augment polymerase chain reaction (PCR)-based analysis. This will provide data to estimate the in vivo survival of lymphocytes derived from the infused cells.|6 years|This outcome measure was not done due to the lack of a minimum number (e.g. 4) of required durable responses in the participants. A durable response is defined as a complete response, partial response, or stable disease in at least 4 participants.|||||
828575|NCT01218867|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|33 months and 25 days|||participants|||Number
828646|NCT01212627|Primary|Determine Maximum Tolerated Dose (MTD) of Ridaforolimus With Given With Cetuximab|"the first testing will occur once the first 3 patients are enrolled and have received 1 cycle DLT's will be evaluated- if everything is ok then the next level of medication will begin
Weekly Ridaforolimus Dose Level 1 20 mg/day Dose Level 2 30 mg/day Dose Level 3 40 mg/day"|1 year|||mg/day|||Number
828647|NCT01212757|Secondary|Number of Participants With Adverse Events||Up to 5 years||12/2017||||
828576|NCT01218867|Primary|Response to Therapy|Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment starts or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.|6 years|||participants|||Number
828577|NCT01218958|Secondary|Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE)|A TEAE is any adverse event, whether or not considered drug-related, that develops or worsens in severity after study drug administration begins (ie, from the first administration through the end of the follow-up period).|24 weeks (Baseline to Week 24)|||Participants|||Number
828578|NCT01218958|Primary|Percentage of Heavy Drinking Days Over the Treatment Period|Drinking rates were assessed from participants' self-reports using the validated Timeline Follow-Back (TLFB) method. Using a TLFB calendar, participants reported the number of days they had consumed alcohol along with the amount they consumed on each day. A heavy drinking day was defined as ≥5 drinks/day for men and ≥4 drinks/day for women.|Baseline through Week 24 (168 days)|The last post-baseline observation carried forward (LOCF) of each participant in the intent-to-treat population (all randomized participants who received at least 1 injection of study drug) were utilized for the primary efficacy analysis.||Percentage of days|Days|Inter-Quartile Range|Median
828579|NCT01218971|Primary|Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While in Study|A TEAE is any adverse event, whether or not considered drug-related, that develops or worsens in severity after study drug administration begins (ie, from the first administration through the end of the follow-up period).|Up to 48 weeks (13 injections), not including base study|All participants who received at least 1 dose of study drug are included in the safety population.||Participants|||Number
828580|NCT01218984|Primary|Slope Change From Baseline for Pupil Size|Photographs of subjects' pupils were measured horizontally and vertically, 15 minutes before the first hydromorphone dose and every 15 minutes after each hydromorphone/placebo for hydromorphone dose, for up to 1 hour. Size was the product of vertical and horizontal measures. The slope, determined by linear regression, was used as a summary measure of the dose-response relationship between the hydromorphone dose and pupil size. The steeper the slope, the greater the hydromorphone effect. A slope of zero indicated no evidence of a hydromorphone effect.|4 weeks (Baseline to Day 28)|Placebo hydromorphone challenge sessions were excluded from the analysis. Results for subjects who discontinued prior to Day 28 were not imputed.||cm(2)/hr||Standard Deviation|Mean
828581|NCT01218997|Primary|Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study|A TEAE was defined as any adverse event (AE) that started or worsened on or after the administration of the first dose of study medication through 30 days after the end of study treatment.|up to 1 year|All subjects who received at least 1 dose of study drug are included in the safety population.||Participants|||Number
828582|NCT01211535|Primary|Change From Baseline (Day 0) in Ocular Comfort Rating at Day 14|"Ocular comfort was rated by the participant on a continuous visual analog scale from 0-100, where 0=extremely uncomfortable, 50=neither comfortable nor uncomfortable, and 100=extremely comfortable. The participant marked a horizontal line across the scale at the point that best described, how your eyes feel right now. A positive number indicates increased ocular comfort; a negative number indicates decreased ocular comfort."|Baseline (Day 0), Day 14|All participants who received regimen, satisfied inclusion/exclusion criteria, and completed the 14-day treatment period (per protocol)||Units on a scale||95% Confidence Interval|Least Squares Mean
828583|NCT01211613|Secondary|Numeric Pain Rating Score.|Self-reported level of low back pain. We used the mean of 3 numeric pain rating scales: 1) current pain; 2) worst pain in the past 24 hours; and 3) average pain over the past week. Three individual 0 to 10 Likert scales were anchored by 0 indicating “no pain” and 10 indicating “unbearable pain”. Our primary statistical analysis looked at the change in pain scores from baseline to 4 weeks (post treatment).|4 weeks (post treatment)|||units on a scale||Standard Deviation|Mean
828584|NCT01211613|Primary|Oswestry Low Back Pain Disability Index|The Oswestry (OSW) Questionnaire provides the level of self-reported impairment of activity of daily living (ADLs) due to low back pain. There are 10 items in the OSW, each rated on a Likert scale from 0-5. The total range of possible scores is from 0 -50, which is converted to a percentage ranging from 0-100. The percentage of self-reported disability ranges from 0='no impairment' to 100='complete impairment'. Our statistical analysis looked at the change in OSW score (in percentage points) from baseline to 4 weeks (post treatment).|4 weeks (post treatment)|||units on a scale||Standard Deviation|Mean
828585|NCT01211665|Primary|Time Course Elimination of Serum Natalizumab Concentration Following Plasma Exchange (PLEX) or Equivalent||Baseline up to 6 months|This study was stopped prematurely due to lack of enrollment; this analysis was not performed.|||||
828586|NCT01211665|Primary|Time Course Change in Clinical Laboratory Values|Clinical laboratory values included chemokines, cytokines, C-reactive protein (CRP), John Cunningham (JC) virus load, and cell count in cerebrospinal fluid.|Screening to 6 months following completion of PLEX (participants began treatment with IVMP within 2 weeks after PLEX [or equivalent]).|This study was stopped prematurely due to lack of enrollment; this analysis was not performed.|||||
828587|NCT01211665|Primary|Time Course Change in Magnetoencephalography (MEG) Results|MEG was used to map brain activity.|Screening to 6 months following completion of PLEX (participants began treatment with IVMP within 2 weeks after PLEX [or equivalent]).|This study was stopped prematurely due to lack of enrollment; no data on this endpoint was collected.|||||
828588|NCT01211665|Primary|Time Course Changes in Brain Magnetic Resonance Imaging (MRI)|The brain MRI data collected included: progressive multifocal leukoencephalopathy (PML) lesion localization, T2 hyperintense lesion volume, and signs of cerebral edema.|Screening to 6 months following completion of PLEX (participants began treatment with IVMP within 2 weeks after PLEX [or equivalent]).|This study was stopped prematurely due to lack of enrollment; this analysis was not performed.|||||
828857|NCT01221441|Secondary|The Number of Patients Experiencing Injection Site Reactions Related to Treatment|The number of patients with observations of the administration site deemed related to treatment with either active or placebo, including arthralgia, swelling, irritation, pain, stiffness or abnormalities|2 Years|All participants receiving placebo or active treatment||participants|||Number
828589|NCT01211665|Primary|Time Course Change in Cerebral Dysfunction Using the Symbol Digit Modalities Test (SDMT)|The SDMT measures the time to pair abstract symbols with specific numbers. The test requires elements of attention, visuoperceptual processing, working memory, and psychomotor speed. The score is the number of correctly coded items from 0-110 in 90 seconds. The total score provides a measure of the speed and accuracy of symbol-digit substitution.|Screening to 6 months following completion of PLEX (participants began treatment with IVMP within 2 weeks after PLEX [or equivalent]).|This study was stopped prematurely due to lack of enrollment; this analysis was not performed.|||||
828590|NCT01211665|Primary|Time Course Change in the Global Clinical Impression of Improvement (GCI-I) Scale|The GCI-I scale is a 7-point scale that assesses how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention, and rates it as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.|Screening to 6 months following completion of PLEX (participants began treatment with intravenous methylprednisolone (IVMP) within 2 weeks after PLEX [or equivalent]).|This study was stopped prematurely due to lack of enrollment; this analysis was not performed.|||||
828591|NCT01211665|Primary|Severity of AEs and SAEs|AEs and SAEs were categorized as mild, moderate or severe according to the following criteria: Mild=barely noticeable to participant or does not make participant uncomfortable; does not influence performance or functioning; prescription drug not ordinarily needed for relief of symptom(s) but may be given because of personality of participant. Moderate=of a sufficient severity to make participant uncomfortable; performance of daily activity is influenced; participant is able to continue in study; treatment for symptom(s) may be needed. Severe=symptoms cause severe discomfort; symptoms cause incapacity or significant impact on participant’s daily life; severity may cause cessation of treatment with study treatment; treatment for symptom(s) may be given and/or participant hospitalized. Please see Outcome Measure 3 for AE and SAE definitions.|from the first dose of study treatment through the end of the treatment period (6 months) + a 4-week post-treatment period|||events|||Number
828592|NCT01211665|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE=any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); however, this does not include an event that, had it occurred in a more severe form, might have caused death; requires hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect. An SAE may also be any other medically important event that, in the opinion of the Investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above.|from the first dose of study treatment through the end of the treatment period (6 months) + a 4-week post-treatment period|||participants|||Number
828593|NCT01211665|Primary|Number of Participants Who Survived at 6 Months Following Completion of Plasma Exchange (PLEX)|Following the completion of rapid removal of natalizumab using PLEX or equivalent.|6 months|||participants|||Number
828594|NCT01211665|Primary|Time Course Change in Functional Status Based on Karnofsky Performance Status Index Through 6 Months Following Completion of Plasma Exchange (PLEX)|The Karnofsky Performance Status Index (KPSI) is an assessment tool intended to assist clinicians and caretakers in gauging a patient's functional status and ability to carry out activities of daily living. A KPSI of 100=normal, no complaints, no evidence of disease; 90=able to carry on normal activity, minor signs or symptoms of disease; 80=normal activity with effort, some signs or symptoms of disease; 70=cares for self, unable to carry on normal activity or do active work; 60=requires occasional assistance but is able to care for most personal needs; 50=requires considerable assistance and frequent medical care; 40=disabled, requires special care and assistance; 30=severely disabled, hospitalization is indicated, although death is not imminent; 20=very sick, hospitalization is necessary, active support treatment is necessary; 10=moribund, fatal processes progressing rapidly; 0=dead.|Baseline up to 6 months|This study was stopped prematurely due to lack of enrollment; this analysis was not performed.|||||
828595|NCT01211730|Secondary|Death Within 1 Year|Death following liver transplant between 1 day and 1 year|1 year|||participants|||Number
828596|NCT01211730|Secondary|Overall Graft Survival at 1 Year||1 year following transplantation|||participants|||Number
828597|NCT01211730|Secondary|Rehospitalization Rates||Within 1 year following transplantation|patients undergoing liver transplant||participants|||Number
828598|NCT01211730|Secondary|Infection Rates||Within 1 year following transplantation|patients having had liver transplants||participants|||Number
828599|NCT01211730|Secondary|Hypoglycemia|Participants experiencing hypoglycemia (glucose < 70 mg/dL) within the first 3- days following transplantation|Within first 3 days following transplantation|Patients having liver transplant||participants|||Number
828600|NCT01211730|Primary|Rejection of Liver Transplant|Liver transplant rejection determined by either biopsy or clinical criteria (>2x transaminases, clinical decision, treatment with high dose steroids and other anti-rejection medications|within 1 year of transplantation|Patients undergoing liver transplant||participants|||Number
828601|NCT01211769|Secondary|Obsessive Compulsive Drinking Scale (OCDS)|The Obsessive Compulsive Drinking Scale (OCDS) is consisted by 14 items rated 0 – 4. The minimum and maximum values possibly obtained in this scale are respectively 0 and 56, this last one, meaning the most craving possible experienced. It is a short and easy to administer scale (average of 5 minutes per self-rating), built to measure severity and improvement during alcoholism treatment trials.|3 months|||Units on a Scale||Standard Deviation|Mean
828602|NCT01211769|Secondary|Short Alcohol Dependence Data Questionnaire (SADD)|The Short Alcohol Dependence Data is a self-completion questionnaire designed to evaluate the presence and the degree of severity of alcohol dependence and consists of 15 questions. The minimum and maximum scores possible are 0 and 45 points respectively. The range of 1-9 is considered as low dependence, 10-19 medium dependence and 20 or more high dependence.|3 months|||Units on a Scale||Standard Deviation|Mean
828603|NCT01211769|Primary|"Drinking Days in the Previous Month"|The Alcohol Timeline Followback (TLFB) is a drinking assessment method that obtains estimates of daily drinking and has been evaluated with clinical and nonclinical populations. Using a calendar, people provide retrospective estimates of their daily drinking over a specified time period that can vary up to 12 months from the interview date.|3 months|||Days||Standard Deviation|Mean
828612|NCT01211873|Primary|"MRI Lesion Visualization (Border Delineation, Internal Morphology and Contrast Enhancement) at Patient Level for Both Pre and Paired Evaluation, Each Lesion is Scored With 3-point Scales."|"To demonstrate the superiority of combined unenhanced and Dotarem enhanced MRI (PAIRED) compared to unenhanced MRI (PRE) in terms of lesion visualization.
Unenhanced MRI refers to MRI before administration of contrast agent. Enhanced MRI refers to MRI after contrast agent injection. Pre refers to unenhanced MRI. PAIRED refer to combined unenhanced and enhanced MRI.
The measure used a specific scale with 3-point levels to assess lesion visualization. At lesion level, the scale range is from 0 through 1 to 2. Score 0 means a worse outcome and score 2 means a better outcome. Patient score is the sum of all lesion scores. Up to 5 of the largest representative lesions were assessed. At patient level, the maximum score is 10, minimum score is 0."|up to 24 hours as the safety is assessed till 24 hours after injection|The primary analysis was performed at the patient level using off-site readings by 3 readers. The number of participants for analysis depended on the number of evaluable cases (pre and paired)determinted by each reader. Only adult participants included in this data set.||units on a scale||Standard Deviation|Mean
828613|NCT01212094|Secondary|Multiple Sclerosis Functional Composite (MSFC)|The MSFC is a three-part standardized assessment tool that measures arm, leg, and cognitive function. The scoring is based on the average Z-score for all three parts of the the assessment.|0 Months|Only 5 patients per group finished Month 24 following 2 years in study drug phase of trial (2 IV doses and 3 IT doses) at the time the study was terminated for futility.||Z score||Inter-Quartile Range|Median
828614|NCT01212094|Secondary|9-Hole Peg Test|"Measure of upper extremity (arm and hand) function where patients are asked to pick up one peg at a time, using one hand only, and putting them into the holes as quickly as possible until all the holes are filled and then removing them one at a time as quickly as possible. The dominant and non-dominant hands are tested twice. The time limit per trial is 5 minutes.
Trial was closed prematurely and therefore formal statistical analysis of the acquired clinical outcomes makes no sense"|0 months|Only 5 patients per group finished Month 24 following 2 years in study drug phase of trial (2 IV doses and 3 IT doses) at the time the study was terminated for futility.||seconds||Inter-Quartile Range|Median
828615|NCT01212094|Secondary|Timed 25 Foot Walk|"Measure of mobility and leg function based on a timed 25 foot walk. Patient is directed to walk as quickly as possible, with or without an assitive device, to one end of a 25foot course and this is repeated for a total of 2 times. The score is the average of the two completed trials.
Trial was closed prematurely and therefore formal statistical analysis of the acquired clinical outcomes makes no sense"|0 months|Only 5 patients per group finished Month 24 following 2 years in study drug phase of trial (2 IV doses and 3 IT doses) at the time the study was terminated for futility.||seconds||Inter-Quartile Range|Median
828616|NCT01212094|Secondary|Scripps Neurological Rating Scale (NRS)|"NRS is a quantitative assessment based on 22 parameters of the neurological exam with scores ranging from maximum of 100 (normal neurological exam) to a minimum of -10 (death due to MS). The higher the score, the better the patient's level of function.
trial was closed prematurely and therefore formal statistical analysis of the acquired clinical outcomes makes no sense"|0 Months|Only 5 patients per group finished Month 24 following 2 years in study drug phase of trial (2 IV doses and 3 IT doses) at the time the study was terminated for futility.||units on a scale||Inter-Quartile Range|Median
828617|NCT01212094|Secondary|EDSS|Trial was closed prematurely and therefore formal statistical analysis of the acquired clinical outcomes was not performed. EDSS is a clinical rating scale for disability ranging from 0 (normal neurological exam) to 10 (death due to MS) in half point increments.|0 months|||units on a scale||Inter-Quartile Range|Mean
828618|NCT01212094|Secondary|Multiple Sclerosis Functional Composite (MSFC)|The MSFC is a three-part standardized assessment tool that measures arm, leg, and cognitive function. The scoring is based on the average Z-score for all three parts of the the assessment.|24 months|Only 5 patients per group finished Month 24 following 2 years in study drug phase of trial (2 IV doses and 3 IT doses) at the time the study was terminated for futility.||Z score||Inter-Quartile Range|Median
828619|NCT01212094|Secondary|9-Hole Peg Test|"Measure of upper extremity (arm and hand) function where patients are asked to pick up one peg at a time, using one hand only, and putting them into the holes as quickly as possible until all the holes are filled and then removing them one at a time as quickly as possible. The dominant and non-dominant hands are tested twice. The time limit per trial is 5 minutes.
Trial was closed prematurely and therefore formal statistical analysis of the acquired clinical outcomes makes no sense"|24 months|Only 5 patients per group finished Month 24 following 2 years in study drug phase of trial (2 IV doses and 3 IT doses) at the time the study was terminated for futility.||seconds||Inter-Quartile Range|Median
828620|NCT01212094|Secondary|Timed 25 Foot Walk|"Measure of mobility and leg function based on a timed 25 foot walk. Patient is directed to walk as quickly as possible, with or without an assitive device, to one end of a 25foot course and this is repeated for a total of 2 times. The score is the average of the two completed trials.
Trial was closed prematurely and therefore formal statistical analysis of the acquired clinical outcomes makes no sense"|24 months|Only 5 patients per group finished Month 24 following 2 years in study drug phase of trial (2 IV doses and 3 IT doses) at the time the study was terminated for futility.||seconds||Inter-Quartile Range|Median
828621|NCT01212094|Secondary|Scripps Neurological Rating Scale (NRS)|"NRS is a quantitative assessment based on 22 parameters of the neurological exam with scores ranging from maximum of 100 (normal neurological exam) to a minimum of -10 (death due to MS). The higher the score, the better the patient's level of function.
trial was closed prematurely and therefore formal statistical analysis of the acquired clinical outcomes makes no sense"|24 months|Only 5 patients per group finished Month 24 following 2 years in study drug phase of trial (2 IV doses and 3 IT doses) at the time the study was terminated for futility.||units on a scale||Inter-Quartile Range|Median
828622|NCT01212094|Secondary|Expanded Disability Status Scale (EDSS)|Trial was closed prematurely and therefore formal statistical analysis of the acquired clinical outcomes was not performed. EDSS is a clinical rating scale for disability ranging from 0 (normal neurological exam) to 10 (death due to MS) in half point increments.|24 months|Only 5 patients per group finished Month 24 following 2 years in study drug phase of trial (2 IV doses and 3 IT doses) at the time the study was terminated for futility||units on a scale||Inter-Quartile Range|Median
828858|NCT01221441|Secondary|The Incidence of Total Knee Arthroplasty|Quantification of the incidence of total knee arthroplasty of the treated knee subsequent to treatment with TissueGene-C|2 Years|All patients that participated in the study||participants|||Number
828623|NCT01212094|Primary|Analysis of Changes in CSF BAFF Induced by Active Treatment (Rituximab) Measured 3 Months After 1st Drug Administration|This outcome is for interim analysis of the efficacy of B cell depletion from the CSF 3 months after giving rituximab or placebo into the cerebrospinal fluid (CSF). It compares concentration of B-cell activating factor (BAFF) before and 3 months after administration of drug into the CSF. We averaged two time-points before treatment (CSF collected 1 year apart, at month -12 and month 0) and compared it to the single time-point (month 3), which was 3 months from the initiation of drug dosing. BAFF is consumed by B cells, therefore effective B cell depletion increases levels of BAFF. The protocol-stipulated threshold for trial continuation was at least 50% increase in CSF BAFF induced by active treatment with significance level p=0.025.|3 months|For the decision to continue trial, only change from baseline to 3 months post-treatment was analyzed in patients who received active drug.||percentage of BAFF change||Inter-Quartile Range|Median
828624|NCT01212094|Primary|Analysis of Changes in CSF CXCL13 Induced by Active Treatment (Rituximab) Measured 3 Months After 1st Drug Administration|This outcome is for interim analysis of the efficacy of B cell depletion from the CSF 3 months after giving rituximab or placebo into the cerebrospinal fluid (CSF). It compares concentration of chemokine CXCL13 before and 3 months after administration of drug into the CSF. We averaged two time-points before treatment (CSF collected 1 year apart, at month -12 and month 0) and compared it to the single time-point (month 3), which was 3 months from the initiation of drug dosing. CXCL13 is released by activated B cells, T cells and by follicular dendritic cells and has been linked previously with MS inflammation in the brain and spinal cord. The protocol-stipulated threshold for trial continuation was at least 25% decrease in CSF CXCL13 induced by active treatment with significance level p=0.025.|3 months|For the decision to continue trial, only change from baseline to 3 months post-treatment was analyzed in patients who received active drug||percentage of b cell depletion||Inter-Quartile Range|Median
828625|NCT01212094|Secondary|Analysis of Changes in CSF B Cell Numbers Between Rituximab and Placebo|This outcome is for interim analysis of the efficacy of B cell depletion from the CSF 3 months after giving rituximab or placebo into the cerebrospinal fluid (CSF). It compares absolute numbers of CSF B cells calculated as proportion of B cells (identified from flow cytometry data) in all immune cells measured in 50-fold concentrated CSF. We averaged two time-points before treatment (CSF collected 1 year apart, at month -12 and month 0) and compared it to the single time-point (month 3), which was 3 months from the initiation of drug dosing.|3 months|These patients were analyzed for the interim analysis for the efficacy of B cell depletion. Trial stipulated stopping criteria for futility.||percentage of b cell depletion||Inter-Quartile Range|Median
828626|NCT01212159|Secondary|LDL Values at Two Week Interval|Participant in the self monitored arm reported LDL every two weeks. LDL goal for treatment was 100 mg/dl and subjects were followed every two weeks to observe mean LDL values.|6 weeks|No self monitoring group had LDL levels only at baseline and 6 months.||mg/dl||Standard Deviation|Mean
828627|NCT01212159|Secondary|Medication Compliance|Self reported comparison of lipid medication compliance between control and intervention subjects, scale 0-4. Highest compliance value indicated by a score of 4.|6 months|||units on a scale||Standard Deviation|Mean
828628|NCT01212159|Primary|LDL Level Change From Baseline|Comparison of serum LDL level between control and intervention subjects|baseline to 6 months|||mg/dl||Standard Deviation|Mean
828629|NCT01212172|Secondary|Pain Rating Scale|Pain during each treatment was measured subjectively by patients on a 0–10 visual analogue scale (0=no pain, 10=unbearable pain).|12 months|||Units on a Scale||95% Confidence Interval|Median
828630|NCT01212172|Primary|Change in Hair Growth|% reduction from baseline hair count at time points 1 month, 6 months and 12 months [following last (5th laser) treatment]|1 month, 6 month, 12 month|||% hair reduction||Standard Deviation|Mean
828631|NCT01212185|Secondary|CIWA-Ar Scores|Clinical Institute Withdrawal Assessment for Alcohol (CIWA) scale modified to include vital sign measurements. The CIWA scale measures each of 10 alcohol withdrawal symptoms between 0 and 6 (least to worst). Also in the modified CIWA score are ratings of body temperature (0-3, normal range to increasingly elevated), pulse (0-6), respirations (0-2), and diastolic blood pressure (0-6). So the range of possible total scores on the modified CIWA is 0-77.|days 1|||units on a scale||Standard Deviation|Mean
828632|NCT01212185|Primary|Total Lorazepam Dosage (in Milligrams)|Total lorazepam (in milligrams) required per subject to complete detoxification|Days 1 to 5|||milligrams of lorazepam||Standard Deviation|Mean
828633|NCT01212302|Primary|Number of Participants Who Were Responders or Low-Responders of Antiplatelet Therapy as a Result of Whole Blood Aggregometry Testing (See Outcome Measure Description)|"In patients treated with aspirin and clopidogrel aggregometry was performed and depending on the results the patients were either responder or low-responder of antiplatelet therapy.
The following definitions were used for clopidogrel low response (CLR: >5 ohm when stimulated with adenosine diphosphate (ADP) 5 μM) and ASA low response (ALR: >0 ohm;stimulated with arachidonic acid 10 μM) with the ChronoLog 590 aggregometer. In the case of low-response alternative antiplatelet therapy was modified according to the study plan (see protocol section)."|2 years|Sample size calculation: With the assumption that the incidence of clopidogrel low response was at least 20% and ASA low response 10%. Choosing a power of 97.5% and a two-sided value of 0.05, an overall sample size was required of at least 400 patients. To compensate for a possible loss of follow-up, we aimed for inclusion of approx. 500 patients.||participants||95% Confidence Interval|Number
828634|NCT01212445|Secondary|Mean Participant Global Assessment of Treatment|At the End of Study Visit, the study staff asked the participant to rate their global assessment of the study treatment according to the following categories: 0 = not at all effective, 1 = a little bit effective, 2 = moderately effective, 3 = quite a bit effective, 4 = extremely effective.|From time of study drug administration up to 2 Days|Intent-to-Treat (ITT) Population: defined as all participants randomized regardless of whether they had taken study treatment.||units on a scale||Standard Deviation|Mean
828655|NCT01212757|Secondary|Change From Baseline in the FACIT-Fatigue Scale Score at Week 52|"The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue. A positive change from baseline score indicates an improvement."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.||units on a scale||Standard Deviation|Mean
828635|NCT01212445|Secondary|Mean VAS Rating for Abdominal Discomfort/Cramping|"The VAS is a psychometric response scale which measures responses along a continuum of values. The Abdominal Discomfort/Cramping VAS uses a 100 mm horizontal line with the two ends representing opposite, extreme limits of the participant's experience with BM-related abdominal discomfort/cramping. Participants marked where they felt they resided between the two ends with a vertical line. The distance from the left end of the VAS (0 mm) to the participant's mark was measured and recorded in mm. Abdominal discomfort/cramping ratings ranged on a continuous scale from 0 to 100 mm, where 0 mm=None and 100 mm= Painful.
Participants completed a VAS after every BM or attempted BM. The VAS ratings recorded in the diaries for each BM were averaged (with range) to yield a single score for each participant. Participant scores were then averaged by treatment group."|From time of study drug treatment up to 24 hours|Participants in the ITT Population (defined as all participants who were randomized regardless of whether they had taken study treatment) who had data available.||mm||Standard Deviation|Mean
828636|NCT01212445|Secondary|Mean VAS Rating for Bloating|"The VAS is a psychometric response scale which measures responses along a continuum of values. The Bloating VAS uses a 100 mm horizontal line with the two ends representing opposite, extreme limits of the participant's experience with BM-related bloating. Participants marked where they felt they resided between the two ends with a vertical line. The distance from the left end of the VAS (0 mm) to the participant's mark was measured and recorded in mm. Bloating ratings ranged on a continuous scale from 0 to 100 mm, where 0 mm=None and 100 mm= Severe.
Participants completed a VAS after every BM or attempted BM. The VAS ratings recorded in the diaries for each BM were averaged (with range) to yield a single score for each participant. Participant scores were then averaged by treatment group."|From time of study drug treatment up to 24 hours|Participants in the ITT Population (defined as all participants who were randomized regardless of whether they had taken study treatment) who had data available.||mm||Standard Deviation|Mean
828637|NCT01212445|Secondary|Mean VAS Rating for Gas|"The VAS is a psychometric response scale which measures responses along a continuum of values. The Gas VAS uses a 100 mm horizontal line with the two ends representing opposite, extreme limits of the participant's experience with BM-related gas. Participants marked where they felt they resided between the two ends with a vertical line. The distance from the left end of the VAS (0 mm) to the participant's mark was measured and recorded in mm. Gas ratings ranged on a continuous scale from 0 to 100 mm, where 0 mm=None and 100 mm= Severe.
Participants completed a VAS after every BM or attempted BM. The VAS ratings recorded in the diaries for each BM were averaged (with range) to yield a single score for each participant. Participant scores were then averaged by treatment group."|From time of study drug treatment up to 24 hours|Participants in the ITT Population (defined as all participants who were randomized regardless of whether they had taken study treatment) who had data available.||mm||Standard Deviation|Mean
828638|NCT01212445|Secondary|Mean Visual Analog Scale (VAS) Rating for BM Control|"The VAS is a psychometric response scale which measures responses along a continuum of values. The BM control VAS uses a 100 mm horizontal line with the two ends representing the opposite, extreme limits of the participant's experience of BM control. Participants marked where they felt they resided between the two ends with a vertical line. The distance from the left end of the VAS (0 mm) to the participant's mark was measured and recorded in mm. BM Control ratings ranged on a continuous scale from 0 to 100 mm, where 0 mm=Calm, not urgent and 100 mm= Not able to hold BM, very urgent.
Participants completed a VAS after every BM or attempted BM. The VAS ratings recorded in the diaries for each BM were averaged (with range) to yield a single score for each participant. Participant scores were then averaged by treatment group"|From time of study drug treatment up to 24 hours|Participants in the ITT Population (defined as all participants who were randomized regardless of whether they had taken study treatment) who had data available.||mm||Standard Deviation|Mean
828639|NCT01212445|Secondary|Percentage of Participants With Successful BM Within 12 Hours of PEG+E Administration|A successful BM was defined as a BM with no straining or hard/lumpy stools.|From time of study drug treatment up to 12 hours|Intent-to-Treat (ITT) Population: defined as all participants randomized regardless of whether they had taken study treatment.||percentage of participants|||Number
828640|NCT01212445|Secondary|Number of Participants With Time To First Successful BM In 0 Days Through 0.5 Days, >0.5 Days Through 1.0 Days, or >1.0 Days Through 1.5 Days After PEG+E Administration|Time to first successful bowel movement was defined as the duration (in days) from the time of first study dose of study treatment until first successful BM (defined as BM without straining and without hard and/or lumpy stool).|From time of study drug administration up to 3 Days|Participants in the ITT Population (defined as all participants who were randomized regardless of whether they had taken study treatment) who had a successful bowel movement (no straining or hard/lumpy stools). Participants who reported no successful BMs were censored.||participants|||Number
828641|NCT01212445|Primary|Percentage of Participants With Successful Bowel Movement (BM) Within 24 Hours of PEG + E Administration|A successful BM was defined as a BM with no straining or hard/lumpy stools.|From time of study drug treatment up to 24 hours|Intent-to-Treat (ITT) Population: defined as all participants randomized regardless of whether they had taken study treatment.||percentage of participants|||Number
828642|NCT01212484|Primary|24 Hour Dopamine Levels|Assay of 24 hour dopamine level excretion in urine|4 weeks|||ug/gCR||Standard Deviation|Mean
828643|NCT01212484|Secondary|Number of Episodes of Daily Nausea||4 weeks|||episodes of nausea||Standard Deviation|Mean
828644|NCT01212484|Primary|Composite Daily Score|Daily scores were reported on a modified version of the Rhodes Index of Nausea, Vomiting and Retching, which included all 5 items relating to nausea and retching. Items addressing vomiting/throwing up were omitted, as all participants had antireflux surgery that prevented vomiting (Nissen fundoplication). Retching distress, nausea distress, number of nausea episodes per day, number of retching episodes per day, and the amount of time spent feeling nauseous were graded on a 5-point scale. Scores range from 0 (no nausea/distress) to 20 (most nausea/distress).|4 weeks|||units on a scale||Standard Deviation|Mean
828645|NCT01212627|Secondary|Check the Tolerability, and Maximum Tolerated Dose (MTD) of Several Dosing Schedules of Oral Ridaforolimus.|the first testing will occur once the first 3 patients are enrolled and have received 1 cycle DLT's will be evaluated- if everything is ok then the next level of medication will begin|1 year||||||
828918|NCT01222078|Primary|Mean Change in Circulating Peripheral T Lymphocytes|Circulating peripheral T lymphocytes were planned to be measured before, during and after dose 1, 4 and 8 of first treatment course. Because of the early termination of the study the data was not analyzed.|Days 1, 4 and 8 of each treatment course|Safety Population||GI/L||Standard Deviation|Mean
828648|NCT01212757|Secondary|Percentage of Participants Achieving a Dactylitis Score of Zero at Week 52|"Percentage of participants with pre-existing dactylitis whose dactylitis severity score improves to zero after 52 weeks.
Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.
Two-sided 95% confidence interval is based on the Clopper-Pearson method."|Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; Participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) and who had sufficient data for a definitive determination of response status at Week 52 are included.||percentage of participants||95% Confidence Interval|Number
828649|NCT01212757|Secondary|Percentage of Participants Achieving a MASES Score of Zero at Week 52|"Percentage of participants with pre-existing enthesopathy whose MASES improves to 0 after 24 weeks. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):
1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right.
The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.
Two-sided 95% confidence interval is based on the Clopper-Pearson method."|Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants with a baseline value > 0 (i.e., pre-existing enthesopathy) and who had sufficient data for a definitive determination of response status at Week 52 are included.||percentage of participants||95% Confidence Interval|Number
828650|NCT01212757|Secondary|Percentage of Participants With an ACR 70 Response at Week 52|"Percentage of participants with an American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:
≥ 70% improvement in 78 tender joint count;
≥ 70% improvement in 76 swollen joint count; and
≥ 70% improvement in at least 3 of the 5 following parameters:
Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
Patient's global assessment of disease activity (measured on a 100 mm VAS);
Physician's global assessment of disease activity (measured on a 100 mm VAS);
Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));
C-Reactive Protein.
Two-sided 95% confidence interval is based on the Clopper-Pearson method."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.||percentage of participants||95% Confidence Interval|Number
828651|NCT01212757|Secondary|Percentage of Participants With an ACR 50 Response at Week 52|"Percentage of participants with an American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:
≥ 50% improvement in 78 tender joint count;
≥ 50% improvement in 76 swollen joint count; and
≥ 50% improvement in at least 3 of the 5 following parameters:
Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
Patient's global assessment of disease activity (measured on a 100 mm VAS);
Physician's global assessment of disease activity (measured on a 100 mm VAS);
Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));
C-Reactive Protein.
Two-sided 95% confidence interval is based on the Clopper-Pearson method."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.||percentage of participants||95% Confidence Interval|Number
828652|NCT01212757|Secondary|Percentage of Participants Achieving Good or Moderate EULAR Response at Week 52|"A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score.
A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 3.2.
A Moderate Response is defined as either:
an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 score of less than or equal to 5.1 or,
an improvement (decrease) in the DAS28 of more than 1.2 and attainment of a DAS28 score of greater than 3.2."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.||percentage of participants|||Number
828653|NCT01212757|Secondary|Percentage of Participants With Dactylitis Improvement ≥ 1 Point at Week 52|"Percentage of participants with pre-existing dactylitis whose dactylitis severity score improved by ≥ 1 after 52 weeks.
Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.
Two-sided 95% confidence interval is based on the Clopper-Pearson method."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; Participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) and who had sufficient data for a definitive determination of response status at Week 52 are included.||percentage of participants||95% Confidence Interval|Number
828654|NCT01212757|Secondary|Percentage of Participants With MASES Improvement ≥ 20% at Week 52|"Percentage of participants with pre-existing enthesopathy whose MASES improved by ≥ 20% from Baseline after 52 weeks. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):
1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right.
The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.
Two-sided 95% confidence interval is based on the Clopper-Pearson method."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) and who had sufficient data for a definitive determination of response status at Week 52 are included.||percentage of participants||95% Confidence Interval|Number
829122|NCT01216631|Secondary|Psoriatic Arthritis Quality of Life Scale (PsQOL)|Change in PsQOL score from baseline|8 weeks||||||
828656|NCT01212757|Secondary|Change From Baseline in the DAS28 at Week 52|"The DAS28 measures the severity of disease at a specific time and is derived from the following variables:
28 tender joint count
28 swollen joint count, which do not include the DIP joints, the hip joint, or the joints below the knee;
C-reactive protein (CRP)
Patient's global assessment of disease activity.
DAS28(CRP) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.||units on a scale||Standard Deviation|Mean
828657|NCT01212757|Secondary|Change From Baseline in the CDAI Score at Week 52|"The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:
28 tender joint count (TJC),
28 swollen joint count (SJC),
Patient's Global Assessment of Disease Activity measured on a 10 cm visual analog scale (VAS), where 0 cm = lowest disease activity and 10 cm = highest;
Physician's Global Assessment of Disease Activity -measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest.
The CDAI score ranges from 0-76 where lower scores indicate less disease activity.
The following thresholds of disease activity have been defined for the CDAI:
Remission: ≤ 2.8 Low Disease Activity: > 2.8 and ≤ 10 Moderate Disease Activity: > 10 and ≤ 22 High Disease Activity: > 22."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.||units on a scale||Standard Deviation|Mean
828658|NCT01212757|Secondary|Change From Baseline in the Dactylitis Severity Score at Week 52|Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet will be rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a baseline value > 0 (i.e., pre-existing dactylitis) and a Week 52 value are included.||units on a scale||Standard Deviation|Mean
828659|NCT01212757|Secondary|Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 52|"The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):
1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right.
The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a baseline value > 0 (i.e., pre-existing enthesopathy) and a Week 52 value are included.||units on a scale||Standard Deviation|Mean
828660|NCT01212757|Secondary|Change From Baseline in the Patient Assessment of Pain at Week 52|"The participant was asked to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents no pain, and the right-hand boundary (score = 100 mm) represents pain as severe as can be imagined. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.||mm||Standard Deviation|Mean
828661|NCT01212757|Secondary|Percentage of Participants With a Modified PsARC Response at Week 52|"Modified PsARC response is defined as improvement in at least 2 of the 4 measures, at least one of which must be tender joint count or swollen joint count, and no worsening in any of the 4 measures:
78 tender joint count,
76 swollen joint count,
Patient global assessment of disease activity, measured on a 100 mm visual Analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest;
Physician global assessment of disease activity, measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest.
Improvement or worsening in joint counts is defined as decrease or increase, respectively, from baseline by ≥ 30%, and improvement or worsening in global assessments is defined as decrease or increase, respectively, from baseline by ≥ 20 mm VAS.
Two-sided 95% confidence interval is based on the Clopper-Pearson method."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.||percentage of participants||95% Confidence Interval|Number
828662|NCT01212757|Secondary|Change From Baseline in the SF-36 Physical Functioning Scale Score at Week 52|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.||units on a scale||Standard Deviation|Mean
828663|NCT01212757|Secondary|Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 52|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.||units on a scale||Standard Deviation|Mean
828919|NCT01222078|Primary|Mean Change in CD4+ and CD8+ T-cell Counts|CD4+ and CD8+ T cells were planned to be measured before, during and after dose 1, 4 and 8 of first treatment course. Because of the early termination of the study the data was not analyzed.|Days 1, 4 and 8 of each treatment course|Safety Population||Percent total lymphocytes||Standard Deviation|Mean
828664|NCT01212757|Secondary|Percentage of Participants With a ACR 20 Response at Week 52|"Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:
≥ 20% improvement in 78 tender joint count;
≥ 20% improvement in 76 swollen joint count; and
≥ 20% improvement in at least 3 of the 5 following parameters:
Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
Patient's global assessment of disease activity (measured on a 100 mm VAS);
Physician's global assessment of disease activity (measured on a 100 mm VAS);
Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));
C-Reactive Protein.
Two-sided 95% confidence interval is based on the Clopper-Pearson method."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population consists of all participants who were randomized or re-randomized to apremilast at any time during the study. Only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.||percentage of participants||95% Confidence Interval|Number
828665|NCT01212757|Secondary|Percentage of Participants Achieving a Dactylitis Score of Zero at Week 24|"Percentage of participants with pre-existing dactylitis whose dactylitis severity score improves to zero after 24 weeks of treatment.
Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present."|Week 24|Full analysis set; participants with a baseline dactylitis severity score > 0 are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
828666|NCT01212757|Secondary|Percentage of Participants Achieving a MASES Score of Zero at Week 24|"Percentage of participants with pre-existing enthesopathy whose MASES improves to 0 after 24 weeks of treatment. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):
1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right.
The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses."|Week 24|Full analysis set; participants with a baseline MASES > 0 are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
828667|NCT01212757|Secondary|Percentage of Participants Achieving a Dactylitis Score of Zero at Week 16|"Percentage of participants with pre-existing dactylitis whose dactylitis severity score improves to zero after 16 weeks of treatment.
Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present."|Week 16|Full analysis set; participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
828668|NCT01212757|Secondary|Percentage of Participants Achieving a MASES Score of Zero at Week 16|"Percentage of participants with pre-existing enthesopathy whose MASES improves to 0 after 16 weeks of treatment. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):
1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right.
The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses."|Week 16|Full analysis set; participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
828669|NCT01212757|Secondary|Percentage of Participants With a ACR 70 Response at Week 24|"Percentage of participants with an American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:
≥ 70% improvement in 78 tender joint count;
≥ 70% improvement in 76 swollen joint count; and
≥ 70% improvement in at least 3 of the 5 following parameters:
Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
Patient's global assessment of disease activity (measured on a 100 mm VAS);
Physician's global assessment of disease activity (measured on a 100 mm VAS);
Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));
C-Reactive Protein."|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
828670|NCT01212757|Secondary|Percentage of Participants With an ACR 50 Response at Week 24|"Percentage of participants with an American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:
≥ 50% improvement in 78 tender joint count;
≥ 50% improvement in 76 swollen joint count; and
≥ 50% improvement in at least 3 of the 5 following parameters:
Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
Patient's global assessment of disease activity (measured on a 100 mm VAS);
Physician's global assessment of disease activity (measured on a 100 mm VAS);
Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));
C-Reactive Protein."|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
828920|NCT01222078|Primary|Mean Change in Total Lymphocyte Count|Total lymphocyte count was planned to be analyzed up to Month 24.|Baseline and up to Month 24|Safety Population. Because of the early termination of the study this endpoint was not collected.|||||
828671|NCT01212757|Secondary|Percentage of Participants With an ACR 70 Response at Week 16|"Percentage of participants with an American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:
≥ 70% improvement in 78 tender joint count;
≥ 70% improvement in 76 swollen joint count; and
≥ 70% improvement in at least 3 of the 5 following parameters:
Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
Patient's global assessment of disease activity (measured on a 100 mm VAS);
Physician's global assessment of disease activity (measured on a 100 mm VAS);
Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));
C-Reactive Protein."|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
828672|NCT01212757|Secondary|Percentage of Participants With a ACR 50 Response at Week 16|"Percentage of participants with an American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:
≥ 50% improvement in 78 tender joint count;
≥ 50% improvement in 76 swollen joint count; and
≥ 50% improvement in at least 3 of the 5 following parameters:
Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
Patient's global assessment of disease activity (measured on a 100 mm VAS);
Physician's global assessment of disease activity (measured on a 100 mm VAS);
Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));
C-Reactive Protein."|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
828673|NCT01212757|Secondary|Percentage of Participants With Good or Moderate EULAR Response at Week 24|"EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score.
A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 3.2.
A Moderate Response is defined as either:
an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 score of less than or equal to 5.1 or,
an improvement (decrease) in the DAS28 of more than 1.2 and attainment of a DAS28 score of greater than 3.2."|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
828674|NCT01212757|Secondary|Percentage of Participants With Dactylitis Improvement ≥ 1 Point at Week 24|"Percentage of participants with pre-existing dactylitis whose dactylitis severity score improved by ≥ 1 after 24 weeks of treatment.
Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present."|Baseline and Week 24|Full analysis set; participants with a baseline dactylitis severity score > 0 are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
828675|NCT01212757|Secondary|Percentage of Participants With MASES Improvement ≥ 20% at Week 24|"Percentage of participants with pre-existing enthesopathy whose MASES improved by ≥ 20% from Baseline after 24 weeks of treatment. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):
1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right.
The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses."|Baseline and Week 24|Full analysis set; participants with a baseline MASES > 0 are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
828676|NCT01212757|Secondary|Percentage of Participants With Good or Moderate European League Against Rheumatism (EULAR) Response at Week 16|"A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score.
A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 3.2.
A Moderate Response is defined as either:
an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 score of less than or equal to 5.1 or,
an improvement (decrease) in the DAS28 of more than 1.2 and attainment of a DAS28 score of greater than 3.2."|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
828677|NCT01212757|Secondary|Percentage of Participants With Dactylitis Improvement ≥ 1 Point at Week 16|"Percentage of participants with pre-existing dactylitis whose dactylitis severity score improved by ≥ 1 after 16 weeks of treatment.
Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present."|Baseline and Week 16|Full analysis set; participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
828812|NCT01213316|Primary|Percentage of Participants With an HIV-1 Viral Load <50 Copies/mL After 48 Weeks of Raltegravir Treatment|The percentage of participants with an HIV-1 viral load <50 copies/mL of HIV-1 RNA after 48 weeks of raltegravir treatment was determined.|Baseline and 48 weeks|The analysis set included all participants who received at least one dose of raltegravir during the observation period.||Percentage of participants||95% Confidence Interval|Number
828678|NCT01212757|Secondary|Percentage of Participants With MASES Improvement ≥ 20% at Week 16|"Percentage of participants with pre-existing enthesopathy whose MASES improved by ≥ 20% from Baseline after 16 weeks of treatment. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):
1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right.
The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses."|Baseline and Week 16|Full analysis set; participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
828679|NCT01212757|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 24|"The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue. A positive change from baseline score indicates an improvement."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||units on a scale||Standard Error|Least Squares Mean
828680|NCT01212757|Secondary|Change From Baseline in the Disease Activity Score (DAS28) at Week 24|"The DAS28 measures the severity of disease at a specific time and is derived from the following variables:
28 tender joint count
28 swollen joint count, which do not include the DIP joints, the hip joint, or the joints below the knee;
C-reactive protein (CRP)
Patient's global assessment of disease activity.
DAS28(CRP) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||units on a scale||Standard Error|Least Squares Mean
828681|NCT01212757|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 24|"The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:
28 tender joint count (TJC),
28 swollen joint count (SJC),
Patient's Global Assessment of Disease Activity measured on a 10 cm visual analog scale (VAS), where 0 cm = lowest disease activity and 10 cm = highest;
Physician's Global Assessment of Disease Activity -measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest.
The CDAI score ranges from 0-76 where lower scores indicate less disease activity.
The following thresholds of disease activity have been defined for the CDAI:
Remission: ≤ 2.8; Low Disease Activity: > 2.8 and ≤ 10; Moderate Disease Activity: > 10 and ≤ 22; High Disease Activity: > 22."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||units on a scale||Standard Error|Least Squares Mean
828682|NCT01212757|Secondary|Change From Baseline in Dactylitis Severity Score at Week 24|Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet will be rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Baseline and Week 24|Full analysis set. Participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) and at least 1 postbaseline value at or prior to Week 24 are included. LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||units on a scale||Standard Error|Least Squares Mean
828683|NCT01212757|Secondary|Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 24|"The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):
1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right.
The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses."|Baseline and Week 24|Full analysis set; participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||units on a scale||Standard Error|Least Squares Mean
828684|NCT01212757|Secondary|Change From Baseline in Patient’s Assessment of Pain at Week 24|"The participant was asked to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents no pain, and the right-hand boundary (score = 100 mm) represents pain as severe as can be imagined. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||mm||Standard Error|Least Squares Mean
828685|NCT01212757|Secondary|Percentage of Participants With a Modified Psoriatic Arthritis Response Criteria (PsARC) Response at Week 24|"Modified PsARC response is defined as improvement in at least 2 of the 4 measures, at least one of which must be tender joint count or swollen joint count, and no worsening in any of the 4 measures:
78 tender joint count,
76 swollen joint count,
Patient global assessment of disease activity, measured on a 100 mm visual Analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest;
Physician global assessment of disease activity, measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest.
Improvement or worsening in joint counts is defined as decrease or increase, respectively, from baseline by ≥ 30%, and improvement or worsening in global assessments is defined as decrease or increase, respectively, from baseline by ≥ 20 mm VAS."|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
828686|NCT01212757|Secondary|Change From Baseline in 36-item Short Form Health Survey (SF-36) Physical Functioning Domain at Week 24|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||units on a scale||Standard Error|Least Squares Mean
828687|NCT01212757|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 16|"The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means “not at all,” and 4 means “very much.” The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue.
A positive change from baseline score indicates an improvement."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included. LOCF was used.||units on a scale||Standard Error|Least Squares Mean
828688|NCT01212757|Secondary|Change From Baseline in the Disease Activity Score (DAS28) at Week 16|"The DAS28 measures the severity of disease at a specific time and is derived from the following variables:
28 tender joint count
28 swollen joint count, which do not include the distal interphalangeal (DIP) joints, the hip joint, or the joints below the knee;
C-reactive protein (CRP)
Patient's global assessment of disease activity.
DAS28(CRP) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included. LOCF was used.||units on a scale||Standard Error|Least Squares Mean
828689|NCT01212757|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 16|"The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:
28 tender joint count (TJC),
28 swollen joint count (SJC),
Patient's Global Assessment of Disease Activity measured on a 10 cm visual analog scale (VAS), where 0 cm = lowest disease activity and 10 cm = highest;
Physician's Global Assessment of Disease Activity -measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest.
The CDAI score ranges from 0-76 where lower scores indicate less disease activity.
The following thresholds of disease activity have been defined for the CDAI:
Remission: ≤ 2.8 Low Disease Activity: > 2.8 and ≤ 10 Moderate Disease Activity: > 10 and ≤ 22 High Disease Activity: > 22."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included. LOCF was used.||units on a scale||Standard Error|Least Squares Mean
828690|NCT01212757|Secondary|Change From Baseline in Dactylitis Severity Score at Week 16|Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet will be rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Baseline and Week 16|Full analysis set. Participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) and at least 1 postbaseline value at or prior to Week 16 are included. LOCF was used.||units on a scale||Standard Error|Least Squares Mean
828691|NCT01212757|Secondary|Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 16|"The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):
1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right.
The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses."|Baseline and Week 16|Full analysis set; participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) and at least 1 postbaseline value at or prior to Week 16 are included; LOCF was used.||units on a scale||Standard Error|Least Squares Mean
828692|NCT01212757|Secondary|Change From Baseline in Patient’s Assessment of Pain at Week 16|The participant was asked to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents “no pain,” and the right-hand boundary (score = 100 mm) represents “pain as severe as can be imagined.” The distance from the mark to the left-hand boundary was recorded in millimeters.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included; LOCF was used.||mm||Standard Error|Least Squares Mean
828693|NCT01212757|Secondary|Percentage of Participants With a Modified Psoriatic Arthritis Response Criteria (PsARC) Response at Week 16|"Modified PsARC response is defined as improvement in at least 2 of the 4 measures, at least one of which must be tender joint count or swollen joint count, and no worsening in any of the 4 measures:
78 tender joint count,
76 swollen joint count,
Patient global assessment of disease activity, measured on a 100 mm visual Analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest;
Physician global assessment of disease activity, measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest.
Improvement or worsening in joint counts is defined as decrease or increase, respectively, from baseline by ≥ 30%, and improvement or worsening in global assessments is defined as decrease or increase, respectively, from baseline by ≥ 20 mm VAS."|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
828694|NCT01212757|Secondary|Change From Baseline in 36-item Short Form Health Survey (SF-36) Physical Functioning Domain at Week 16|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included; LOCF was used.||units on a scale||Standard Error|Least Squares Mean
828695|NCT01212757|Secondary|Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 24|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||units on a scale||Standard Error|Least Squares Mean
828696|NCT01212757|Secondary|Percentage of Participants With an ACR 20 Response at Week 24|"Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:
≥ 20% improvement in 78 tender joint count;
≥ 20% improvement in 76 swollen joint count; and
≥ 20% improvement in at least 3 of the 5 following parameters:
Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
Patient's global assessment of disease activity (measured on a 100 mm VAS);
Physician's global assessment of disease activity (measured on a 100 mm VAS);
Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));
C-Reactive Protein."|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
828697|NCT01212757|Secondary|Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 16|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included; Last observation carried forward (LOCF) imputation was used.||units on a scale||Standard Error|Least Squares Mean
828698|NCT01212757|Primary|Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 16|"Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:
≥ 20% improvement in 78 tender joint count;
≥ 20% improvement in 76 swollen joint count; and
≥ 20% improvement in at least 3 of the 5 following parameters:
Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
Patient's global assessment of disease activity (measured on a 100 mm VAS);
Physician's global assessment of disease activity (measured on a 100 mm VAS);
Patient’s self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));
C-Reactive Protein."|Baseline and Week 16|Full analysis set consisting of all participants randomized as specified in the protocol; participants who were randomized in error and did not receive any dose of study drug were excluded. Participants who withdrew early or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
828850|NCT01221350|Secondary|Induced Sputum of Glutathione (GSH)/Glutathione Disulfide (GSSG) Ratio at Baseline|Induced sputum of GSH and GSSG levels at baseline. The ratio GSH/GSSG is considered an index of antioxidant status and reductive -SH groups. GSH and GSSG were measured by a microplate fluorescent assay.|Baseline|||ratio||95% Confidence Interval|Mean
829123|NCT01216631|Secondary|Psoriatic Arthritis Quality of Life Scale (PsQOL)|Change in PsQOL score from baseline|6 weeks||||||
828851|NCT01221350|Primary|Spirometric FVC Values at Baseline|Measurement of spirometric predicted parameters at baseline. Forced vital capacity (FVC) is the volume of air that can forcibly be blown out after full inspiration, measured in liters.|Baseline|||Liters||Standard Deviation|Mean
829124|NCT01216631|Secondary|Psoriatic Arthritis Quality of Life Scale (PsQOL)|Change in PsQOL score from baseline|26 weeks||||||
828777|NCT01213173|Secondary|The Difference of Change From Baseline in Angina Frequency Between Groups|Difference in change from baseline of angina pectoris frequency between two groups after 8 weeks treatment.|After 8 weeks treatment|ITT population was defined as all randomized subjects who had taken at least one dose of trial treatment, who had measurements at baseline for one or more efficacy variables and at least one post baseline measurement for the same variables in the treatment period.||Attacks per week||95% Confidence Interval|Least Squares Mean
828852|NCT01221363|Secondary|Change in High Density Lipoprotein (HDL) From Baseline to 6 Months Follow-up.|Blood samples are drawn at inclusion and at 6 months follow-up. Change in measured HDL (mmol/L) from baseline to 6 months follow-up|Change in measured HDL from baseline and 6 months follow-up|||mmol/Liter||Standard Deviation|Mean
828754|NCT01212874|Secondary|Title: Systolic Hypertension|Area under the curve (AUC) of Systolic Blood Pressure Excursions Beyond Predetermined Upper Limits, Normalized Per Hour from Anesthesia Induction to Initiation of Cardiopulmonary Bypass|Duration: during infusion of study drug|Data capture failure lost data from 2 treated patients in each group; these were thus excluded from analysis.||mmHg*min / prebypass hour||95% Confidence Interval|Median
828755|NCT01212874|Primary|Diastolic Blood Pressure Excursions Beyond Predetermined Lower Limits, Normalized Per Hour|Area under the curve (AUC) of Diastolic Blood Pressure Excursions Beyond Predetermined Lower Limits, Normalized Per Hour from Anesthesia Induction to Initiation of Cardiopulmonary Bypass|Participation could last up to 2 weeks, representing the day of surgery until discharge from the hospital.|Data capture failure lost data from 2 treated patients in each group; these were thus excluded from analysis.||mmHg*min/prebypass hour||95% Confidence Interval|Median
828756|NCT01212991|Secondary|Best Overall Soft Tissue Response|The best overall soft tissue objective response is defined as partial response [PR] or complete response [CR] while on study treatment based on investigator assessments of target, nontarget, and new lesions using RECIST 1.1. Soft tissue was assessed by CT or MRI at regularly scheduled visits. Only patients with measurable soft tissue disease (ie, at least 1 target lesion identified per RECIST 1.1) at screening are included in this analysis. All percentages are based on number of participants with measurable soft tissue disease at screening in each treatment group.|During study period (up to 3 years)|Intent to treat (ITT) population With Measurable Disease - All participants who were randomly assigned to treatment and had at least one target lesion at screening.||Percentage of participants|||Number
828757|NCT01212991|Secondary|Percentage of Patients With Prostate Specific Antigen (PSA) Response ≥ 50%|PSA response was defined as a ≥ 50% reduction in PSA from baseline to the lowest postbaseline PSA value and required confirmation by a consecutive assessment at least 3 weeks later. Patients were evaluable for PSA response rate if a patient had a PSA level measured at baseline and at least one postbaseline assessment.|During study period (up to 3 years)|Evaluable intent to treat (ITT) population - All patients randomly assigned to treatment with PSA values at baseline and at least one postbaseline assessment.||Percentage of Participants||95% Confidence Interval|Number
828758|NCT01212991|Secondary|Time to Prostate-specific Antigen (PSA) Progression|Time to PSA progression was defined as the time from randomization to date of first confirmed observation of PSA progression for each patient. For patients with PSA declines at week 13, the PSA progression date was defined as the date that a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the nadir was documented, and confirmed 3 or more weeks later. For patients with no PSA decline at week 13, the PSA progression date was defined as the date that a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above baseline was documented, and confirmed 3 or more weeks later. For patients who did not have confirmed PSA progression at the time of the analysis data cutoff, time to PSA progression was censored at the date of the last PSA assessment showing no evidence of confirmed PSA progression or the analysis data cutoff date, whichever was first. Time to PSA progression for patients with no postbaseline assessments was censored on the date of randomization.|During study period (up to 3 years)|Intent to Treat (ITT) - All patients randomized.||months||95% Confidence Interval|Median
828759|NCT01212991|Secondary|Time to Initiation of Cytotoxic Chemotherapy|The time to initiation of cytotoxic chemotherapy is defined as the time from randomization to the date of initiation of cytotoxic chemotherapy for the treatment of prostate cancer for each patient. For patients who did not start cytotoxic chemotherapy at the time of the analysis data cutoff, time to initiation of cytotoxic chemotherapy was censored at the date of last assessment where no cytotoxic chemotherapy was indicated or at the analysis data cutoff date, whichever was first. Time to initiation of cytotoxic chemotherapy for patients with no postbaseline assessments was censored on the date of randomization.|During study period (up to 3 years)|Intent to Treat (ITT) - All patients randomly assigned to treatment.||months||95% Confidence Interval|Median
828760|NCT01212991|Secondary|Time to First Skeletal-related Event|Time to first skeletal-related event was defined as the time from randomization to the date of the first occurrence of a skeletal-related event for each patient. A skeletal-related event was defined as radiation therapy or surgery to bone for prostate cancer, pathological bone fracture, spinal cord compression, or initiation/change in antineoplastic therapy to treat bone pain from prostate cancer. Skeletal-related events were recorded at each scheduled and unscheduled study visit and during long-term follow-up if a skeletal-related event was not documented previously. Patients who did not have a skeletal-related event at the time of the analysis data cutoff were censored at the date of last assessment indicating no evidence of skeletal-related event. Patients with no postbaseline assessments were censored on the date of randomization.|During study period (up to 3 years)|Intent to Treat (ITT) - All patients randomly assigned to treatment.||months||95% Confidence Interval|Median
828778|NCT01213173|Secondary|The Difference of Change From Baseline in Angina Frequency Between Groups|Difference in change from baseline of angina pectoris frequency between two groups after 2 weeks treatment.|After 2 weeks treatment|ITT population was defined as all randomized subjects who had taken at least one dose of trial treatment, who had measurements at baseline for one or more efficacy variables and at least one post baseline measurement for the same variables in the treatment period.||Attacks per week||95% Confidence Interval|Least Squares Mean
828996|NCT01222533|Secondary|FEV1 Area Under the Curve 0 to 3 Hours (AUC0-3h) at the End of Each Treatment Period|FEV1 AUC0-3h calculated from zero time to 3 hours using the trapezoidal rule divided by 3 hours. Trough FEV1 will be assigned to zero time. Means are adjusted for sequence, patients within sequences, period and treatment.|4 weeks|FAS with imputed data.||Liter||Standard Error|Mean
828761|NCT01212991|Primary|Radiographic Progression-free Survival|Radiographic progression-free survival was defined as the time from randomization to the first objective evidence of radiographic disease progression assessed by independent central radiology review or death due to any cause within 168 days after treatment discontinuation, whichever was first. Radiographic disease progression was evaluated by CT scan or MRI and radionuclide bone scans at regularly scheduled visits. Radiographic disease progression in bone required a confirmatory scan. Radiographic disease progression in soft tissue did not require a confirmatory scan for purposes of analysis. Radiographic disease progression was evaluated by independent central radiology review using RECIST 1.1 for soft tissue disease and PCWG2 guidelines for bone disease. Patients who did not reach the endpoint were censored at their last assessment.|During study period (up to 20 months)|Intent to Treat (ITT) - All patients randomly assigned to treatment excluding 84 patients who were not randomized before the radiographic Progression-free Survival data cutoff date of 06 May 2012.||months||95% Confidence Interval|Median
828762|NCT01212991|Primary|Overall Survival|Overall survival was defined as the time from randomization to death due to any cause. For patients who were alive at the time of the analysis data cutoff, overall survival was censored at the last date the patient was known to be alive or analysis data cutoff date, whichever was first. This included patients who were known to have died after the data analysis cutoff date. Patients with no post-baseline survival information were censored on the date of randomization.|During study period (up to 3 years)|Intent to Treat (ITT) - All patients randomly assigned to treatment.||months||95% Confidence Interval|Median
828763|NCT01213043|Primary|Number of Treatment-Emergent Pulmonary Exacerbations|Total number of treatment-emergent pulmonary exacerbations.|22 Weeks|All safety analyses were performed on the safety population, which comprised of all subjects who were randomized and received at least one dose of investigational product (Prolastin-C).||Events|||Number
828764|NCT01213043|Primary|Number of Drug-related TEAEs|Total number of drug-related TEAEs reported|22 Weeks|All safety analyses were performed on the safety population, which comprised of all subjects who were randomized and received at least one dose of investigational product (Prolastin-C).||Events|||Number
828765|NCT01213043|Primary|Number of TEAEs|Total number of TEAEs reported.|22 Weeks|All safety analyses were performed on the safety population, which comprised of all subjects who were randomized and received at least one dose of investigational product (Prolastin-C).||Events|||Number
828766|NCT01213043|Secondary|Mean Trough|The average trough concentration at steady-state, calculated as the mean value using the four Trough measurements obtained at Weeks 6, 7, 8 and at 7 days (168 hours) post infusion at Week 8 for the first treatment period or prior to the start of the infusions at Weeks 16, 17, 18, and at 7 days (168 hours) post infusion at Week 18 for the second treatment period.|Single measurment immediately prior to infusion at Weeks 6, 7, 8, 9 and Weeks 16, 17, 18, 19|PK Population, which consisted of all subjects who received investigational product (Prolastin-C) and had sufficient and valid serum concentration data to facilitate calculation of PK parameters.||μM||Standard Deviation|Mean
828767|NCT01213043|Primary|Subjects With Severe TEAE(s) or Pulmonary Exacerbation(s)|Number of subjects who experienced at least one severe TEAE or pulmonary exacerbation.|22 weeks|All safety analyses were performed on the safety population, which comprised of all subjects who were randomized and received at least one dose of investigational product (Prolastin-C).||participants|||Number
828768|NCT01213043|Primary|Subjects With Treatment-Emergent Pulmonary Exacerbation(s)|Number of subjects with at least one treatment-emergent pulmonary exacerbation|22 weeks|All safety analyses were performed on the safety population, which comprised of all subjects who were randomized and received at least one dose of investigational product (Prolastin-C).||participants|||Number
828769|NCT01213043|Primary|Subjects Withdrawn Due to an AE(s)|Number of subjects who were withdrawn from the study due to at least one AE.|22 weeks|All safety analyses were performed on the safety population, which comprised of all subjects who were randomized and received at least one dose of investigational product (Prolastin-C).||participants|||Number
828770|NCT01213043|Primary|Subjects With Treatment-Emergent Serious Adverse Events (SAEs)|Number of subjects who experienced at least one treatment-emergent SAE.|22 weeks|All safety analyses were performed on the safety population, which comprised of all subjects who were randomized and received at least one dose of investigational product (Prolastin-C).||participants|||Number
828771|NCT01213043|Primary|Subjects With Drug-Related TEAE(s)|Number of subjects with at least one TEAE that was determined by the Investigator to be either “possibly related” or “related” to the investigational product (i.e., Prolastin-C).|22 weeks|All safety analyses were performed on the safety population, which comprised of all subjects who were randomized and received at least one dose of investigational product (Prolastin-C).||participants|||Number
828772|NCT01213043|Secondary|AUC0-7days|Area Under the Alpha-1 PI Concentration-Time Curve from Day 0 to Day 7|Week 8 and Week 18 at the following timepoints: 0 (pre-infusion), completion of first infusion bag, completion of 2nd infusion bag, and 15 min, 30 min, and 1, 2, 4, 8, 24, 48, 120, and 168 hours post-dose|Pharmacokinetic (PK) Population, which consisted of all subjects who received investigational product (Prolastin-C) and had sufficient and valid serum concentration data to facilitate calculation of PK parameters.||h*mg/mL||Standard Deviation|Mean
828773|NCT01213043|Primary|Subjects With Treatment-Emergent Adverse Events (TEAEs)|Number of subjects experiencing at least one TEAE. TEAEs were defined as any adverse event (AE) during the study that began on or after the date of first dose of investigational product (i.e., Prolastin-C).|22 weeks|All safety analyses were performed on the safety population, which comprised of all subjects who were randomized and received at least one dose of investigational product (Prolastin-C).||participants|||Number
828774|NCT01213173|Secondary|The Change From Baseline in Triglycerides|Difference of change from baseline in TG after 8 weeks treatment between groups.|After 8 weeks treatment|All subjects who received at least one dose of randomized investigational product was included in the safety population.||mmol/L||95% Confidence Interval|Least Squares Mean
828775|NCT01213173|Secondary|The Change From Baseline in Fasting Plasma Glucose|Difference of change from baseline in FPG after 8 weeks treatment between groups.|After 8 weeks treatment|All subjects who received at least one dose of randomized investigational product was included in the safety population.||mmol/L||95% Confidence Interval|Least Squares Mean
828776|NCT01213173|Secondary|The Change From Baseline in Total Cholesterol|Difference of change from baseline in TC after 8 weeks treatment between groups.|After 8 weeks treatment|All subjects who received at least one dose of randomized investigational product was included in the safety population.||mmol/L||95% Confidence Interval|Least Squares Mean
828779|NCT01213173|Secondary|The Difference of Change From Baseline in Total Ischemic Burden Between Groups|"Difference in change from baseline in TIB between two groups after 8 weeks treatment.
Total Ischemic Burden (TIB) was defined as the sum of product of each ischemia episode lasting time and maximal ST elevation: TIB=Σ(STmax×Tisc)."|After 8 weeks treatment|ITT population was defined as all randomized subjects who had taken at least one dose of trial treatment, who had measurements at baseline for one or more efficacy variables and at least one post baseline measurement for the same variables in the treatment period.||mm*min||95% Confidence Interval|Least Squares Mean
828780|NCT01213173|Secondary|The Difference of Change From Baseline in Total Ischemic Burden Between Groups|"Difference in change from baseline in TIB between two groups after 2 weeks treatment.
Total Ischemic Burden (TIB) was defined as the sum of product of each ischemia episode lasting time and maximal ST elevation: TIB=Σ(STmax×Tisc)."|After 2 weeks treatment|ITT population was defined as all randomized subjects who had taken at least one dose of trial treatment, who had measurements at baseline for one or more efficacy variables and at least one post baseline measurement for the same variables in the treatment period.||mm*min||95% Confidence Interval|Least Squares Mean
828781|NCT01213173|Secondary|The Proportion of Patients With Resting Heart Rate Controlled to ≤60bpm Between Groups|Difference in proportions of patients who had resting heart rate controlled to ≤60 bpm after 8 weeks treatment between groups|After 8 weeks treatment|ITT population was defined as all randomized subjects who had taken at least one dose of trial treatment, who had measurements at baseline for one or more efficacy variables and at least one post baseline measurement for the same variables in the treatment period.||Participants|||Number
828782|NCT01213173|Secondary|The Proportion of Patients With Resting Heart Rate Controlled to ≤60bpm Between Groups|Difference in proportions of patients who had resting heart rate controlled to ≤60 bpm after 2 weeks treatment between groups|After 2 weeks treatment|ITT population was defined as all randomized subjects who had taken at least one dose of trial treatment, who had measurements at baseline for one or more efficacy variables and at least one post baseline measurement for the same variables in the treatment period.||Participants|||Number
828783|NCT01213173|Secondary|The Different Impact on 24-hr Average Heart Rate From Baseline Within Groups|Difference of the 24-hr average heart rate within groups from baseline after 2 weeks treatment.|After 2 weeks treatment in the study|ITT population was defined as all randomized subjects who had taken at least one dose of trial treatment, who had measurements at baseline for one or more efficacy variables and at least one post baseline measurement for the same variables in the treatment period.||Bpm||95% Confidence Interval|Least Squares Mean
828784|NCT01213173|Secondary|The Different Impact on 24-hr Average Heart Rate Between Two Groups|Difference of the 24-hr average heart rate between two groups after 2 weeks of treatment.|After 2 weeks treatment in the study|ITT population was defined as all randomized subjects who had taken at least one dose of trial treatment, who had measurements at baseline for one or more efficacy variables and at least one post baseline measurement for the same variables in the treatment period.||Bpm||Standard Deviation|Mean
828785|NCT01213173|Secondary|The Impact on 24-hr Average Heart Rate From Baseline Within Groups|Difference of the 24-hr average heart rate within groups from baseline after 8 weeks treatment.|After 8 weeks treatment in the study|ITT population was defined as all randomized subjects who had taken at least one dose of trial treatment, who had measurements at baseline for one or more efficacy variables and at least one post baseline measurement for the same variables in the treatment period.||Bpm||95% Confidence Interval|Least Squares Mean
828786|NCT01213173|Primary|The Impact on 24-hr Average Heart Rate Between Two Groups (Betaloc ZOK® 95mg vs. 190mg)|Difference of the 24-hr average heart rate between two groups after 8 weeks treatment.|After 8 weeks treatment in the study|ITT population was defined as all randomized subjects who had taken at least one dose of trial treatment, who had measurements at baseline for one or more efficacy variables and at least one post baseline measurement for the same variables in the treatment period.||Bpm||Standard Deviation|Mean
828787|NCT01213199|Primary|Global Scarring Severity|"Grade Level:
Macular disease
Mild disease
Moderate disease
Severe disease"|Week 24|The analysis population includes 18 subjects whose data were available at this time frame (week 24).||units on a scale||Standard Deviation|Mean
828788|NCT01213251|Secondary|Linear Association Between Change in LVEDV and Selected Clinical Characteristics; Including Peak Creatinine Phosphokinase (CPK), Peak Troponin, Lead Location, Time From MI Onset to Implant, and Change in LV Volumes.|"Linear association between change in LVEDV from baseline to 18-month visit (i.e. ΔLVEDV) and the following clinical characteristics were assessed: age, days from MI to implant, gender, hypertension, hyperlipidemia, diabetes, peak CPK, infarct location, LV electrode in acceptable place, and baseline LVEF. In order to assess these linear associations, linear regression models were fitted for each of these clinical characteristics (separately). In particular, each linear regression model had baseline LVEDV and the clinical characteristic as covariates, and ΔLVEDV was the response variable.
Variables resulting in statistical significant (p<0.05) are reported."|Baseline - 18 Month Follow Up Visit|All subjects randomized, and if randomized to Dual Site or Single Site, the subject must have had a successful implant. Moreover, only subjects with observed LVEDV at baseline and 18-month follow-up visit are included.||regression coefficient||Standard Error|Mean
828789|NCT01213251|Secondary|Incidence of Sudden Cardiac Death and Total Mortality|"Mortality rates (%) for the events (a) all-cause death and (b) sudden-cardiac death at 18 months post randomization. Calculated using Kaplan-Meier methods.
Per protocol the comparison of mortality rates is between Pooled Pacing (Dual Site + Single Site) and Control."|18 Months post-randomization|Randomized subjects, and if randomized to Dual Site or Single Site, the subject must have had a successful implant.||percentage of subjects at risk||95% Confidence Interval|Number
828790|NCT01213251|Secondary|Change in Quality of Life|"Change in the Minnesota Living with Heart Failure (MNLWHF) questionnaire from baseline to the 18-month follow-up visit.
Change is defined as month 18 minus baseline.
Per protocol change in MNLWHF is compared between Pooled Pacing (Dual Site + Single Site) and Control."|Baseline - 18 Month Follow Up Visit|Randomized subjects, and if randomized to Dual Site or Single Site, the subject must have had a successful implant. Moreover, only subjects with observed MNLWHF questionnaire score at baseline and 18-month follow-up visits are included.||units on a scale||95% Confidence Interval|Mean
829125|NCT01216631|Secondary|Pain Visual Analogue Scale|Change in patient's assessment of pain by a 100mm visual analogue score|16 weeks||||||
829126|NCT01216631|Secondary|Pain Visual Analogue Scale|Change in patient's assessment of pain by a 100mm visual analogue score|14 weeks||||||
828791|NCT01213251|Secondary|Change in 6-minute Walk Test Distance|"Change in 6-minute hallwalk distance from 1-month visit to the 18-month visit.
Change is defined as month 18 minus baseline.
Per protocol, change in 6-minute walk test distance is compared between Pooled Pacing (Single site + Dual Site) and Control."|1 Month - 18 Month Follow Up Visit|Randomized subjects, and if randomized to Dual Site or Single Site, the subject must have had a successful implant. Moreover, only subjects with observed 6-minute hallwalk distance at baseline and 18-month follow-up visits are included.||meters||95% Confidence Interval|Mean
828792|NCT01213251|Secondary|Change in New York Heart Association (NYHA) Functional Class|"The New York Heart Association (NYHA) score classifies patients' heart failure according to the severity of their symptoms. In particular, Class I: No limitation of physical activity. Class II: Slight limitation of physical activity. Class III: Marked limitation of physical activity. Class IV: Unable to carry on any physical activity without discomfort.
NYHA change from baseline to 18-month visit. If a subject improved by one NYHA class or more (e.g. NYHA IV to NYHA II, or NYHA III to NYHA I, etc) from the baseline visit, the subject was classified as “Improved”. Similarly for “Worsened” (e.g. subject does not have heart failure to NYHA I, NYHA I to NYHA II, etc.). If the subjects’ NYHA Class is not different than baseline, then the subject was classified as No Change.
Per protocol, change in NYHA is compared between Pooled Pacing (Single site + Dual Site) and Control."|Baseline - 18 Month Follow Up Visit|Subject was randomized, and if randomized to Dual Site or Single Site, the subject must have had a successful implant. Moreover, only subjects with observed NYHA at baseline and 18-month follow-up visit are included.||participants|||Number
828793|NCT01213251|Secondary|Frequency of Hospitalization for Cardiovascular Events|Number of hospitalizations related to cardiovascular events.|Baseline - 18 Month Follow Up Visit|Subject was randomized, and if randomized to Dual Site or Single Site, the subject must have had a successful implant.||participants|||Number
828794|NCT01213251|Secondary|Safety of Implanting a Cardiac Resynchronization Therapy With Defibrillator (CRT-D) Device Within 10 Days of Myocardial Infarction (MI), as Measured by the Rate of Reported Adverse Events|Survival estimates at 18 months post-implant for time to first following events: (a) System Related Adverse Event (b) System Related Complication (c) Procedure Related Adverse Event (d) Procedure Related Complication and (e) System Related or Procedure Related Complication.|18 months post-implant|Only subjects with attempt implant are included. Therefore, subjects from the Control Arm are not included.||survival probability||95% Confidence Interval|Number
828795|NCT01213251|Primary|Change in Left Ventricular End Diastolic Volume (LVEDV)|"Left ventricular end diastolic volume (LVEDV) was measured by echocardiogram. Change was measured as Month 18 LVEDV minus baseline LVEDV.
Per protocol, change in LVEDV is compared between Pooled Pacing (Single site + Dual Site) and Control."|Baseline - 18 Month Follow Up Visit|The primary analysis cohort for the main objective of this study (Change in Left Ventricular End Diastolic Volume) required a subject to be randomized, and if randomized to Dual Site or Single Site, the subject must have had a successful implant. Moreover, only subjects with observed LVEDV at baseline and 18-month follow-up visit are included.||mL||95% Confidence Interval|Mean
828796|NCT01213264|Primary|Type of NMB-reversal Agent Administered to Study Participants|For all participants who received an NMB-reversal agent, the specific agent administered was recorded.|At administration of NMB-reversal agent (up to approximately 395 minutes after start of surgery)|All study participants who received an NMBA or NMB-reversal agent||participants|||Number
828797|NCT01213264|Secondary|Time From NMB-reversal Agent Administration to Recovery Room Dismissal|This measure is the duration from NMB-reversal agent administration to dismissal of the participant from the Recovery Room. The time of dismissal from the Recovery Room was to be recorded for each participant, irrespective of the criteria used to make the decision to dismiss the participant.|Post-surgical and recovery period (up to approximately 170 hours post-surgery)|Evaluable participants who received an NMB-reversal agent and had available procedure duration data. Participants in the Spontaneous Reversal group did not receive any NMB-reversal agents and therefore were not included in this analysis.||minutes||Standard Deviation|Mean
828798|NCT01213264|Secondary|Time From NMB-reversal Agent Administration to Operating Room Dismissal|This measure is the duration from NMB-reversal agent administration to dismissal of the participant from the Operating Room. The time of dismissal from the Operating Room was to be recorded for each participant, irrespective of the criteria used to make the decision to dismiss the participant.|Post-surgical period (up to approximately 24 hours post-surgery)|Evaluable participants who received an NMB-reversal agent and had available procedure duration data. Participants in the Spontaneous Reversal group did not receive any NMB-reversal agents and therefore were not included in this analysis.||minutes||Standard Deviation|Mean
828799|NCT01213264|Primary|Type of Surgical Procedure Performed in Study Participants|The type of surgical procedure performed in each study participant was recorded.|Day of surgery (Day 1)|All study participants who received a neuromuscular blocking agent (NMBA) or NMB-reversal agent||participants|||Number
828800|NCT01213264|Primary|Time From End of Surgery (End of Last Stitch) to Extubation|"This measure is the duration from the last surgical wound stitch to the post-surgical extubation of the participant. The time of extubation was to be recorded for each participant, irrespective of the criteria used to make the decision to extubate the participant. Data are presented by TOF-ratio <0.9 and ≥0.9 at extubation. The TOF-ratio is a measure of neuromuscular function ranging from 0.0 to 1.0. The greater the T4/T1 ratio the greater
the recovery from neuromuscular blockade. TOF-ratio <0.9 at extubation is considered to indicate a high risk for development of postoperative residual curarization (i.e, residual neuromuscular blockade), which can result in respiratory complications."|From end of surgery (end of last stitch) to extubation (duration of approximately <1 to 62 minutes)|Evaluable participants with TOF-ratio measurement at time of extubation and available procedure duration data. Three sugammadex participants with duration from end of surgery to extubation >1 hour were excluded from analysis; delay of extubation was considered due to factors unrelated to administration of sugammadex.||minutes||Standard Deviation|Mean
828811|NCT01213316|Primary|Percentage of Aging Participants With an HIV-1 Viral Load <50 Copies/mL After 48 Weeks of Raltegravir Treatment|The percentage of aging participants (>=50 years old at initiation of raltegravir treatment) with an HIV-1 viral load <50 copies/mL of HIV-1 RNA after 48 weeks of raltegravir treatment was determined.|Baseline and 48 weeks|The analysis set included aging participants (Prolonged Participants and Newly Enrolled Participants) who received at least one dose of raltegravir during the observation period.||Percentage of participants||95% Confidence Interval|Number
828801|NCT01213264|Primary|Number of Participants With a Train-Of-Four (TOF)-Ratio <0.9 at Extubation|Neuromuscular function assessment was performed according to routine anesthesiology practice. This typically involves application of repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve and assessment of twitch response at the adductor pollicis muscle. The TOF-ratio, expressed as a decimal from 0.0 up to 1.0, is the ratio of the magnitude of the fourth twitch (T4) to that of the first twitch (T1). The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade. The TOF-ratio was measured at the time of post-surgical extubation. TOF-ratio at time of extubation was to be recorded for each participant, if available, irrespective of the criteria used to make the decision to extubate the participant. TOF-ratio <0.9 at extubation is considered to indicate a high risk for development of postoperative residual curarization (i.e, residual neuromuscular blockade), which can result in respiratory complications.|At extubation (approximately <1 to 125 minutes after end of surgery)|Evaluable participants with TOF-ratio measurement at time of extubation||participants|||Number
828802|NCT01213316|Secondary|Percentage of Aging Participants Taking Concomitant Medications at Baseline|The percentage of aging participants taking concomitant medication in addition to their other antiretroviral therapy was reported. This Outcome Measure was added with Amendment 1 and applies only to aging participants.|Baseline|The analysis set included aging participants (Prolonged Participants and Newly Enrolled Participants) who received at least one dose of raltegravir during the observation period.||Percentage of participants|||Number
828803|NCT01213316|Secondary|Percentage of Aging Participants With Concomitant Diseases at Baseline|The percentage of aging participants with Baseline comorbidities was reported. This Outcome Measure was added with Amendment 1 and applies only to aging participants.|Baseline|The analysis set included aging participants (Prolonged Participants and Newly Enrolled Participants) who received at least one dose of raltegravir during the observation period.||Percentage of participants|||Number
828804|NCT01213316|Secondary|Change From Baseline in Mean D:A:D Risk Score for the 5-Year Cardiovascular Risk in Aging Participants After 48 Weeks of Raltegravir Treatment|Mean Data Collection on Adverse Events of Anti-HIV Drugs (D:A:D) Risk Score for 5-year cardiovascular risk was determined in aging participants (>=50 years old at initiation of raltegravir treatment) at Baseline and after 48 weeks of raltegravir treatment. The score included the following 8 risk factors: sex, age, systolic blood pressure, family cardiovascular disease history, current smoking, previous cigarette smoker, diabetes, total cholesterol, high-density lipoprotein, currently on indinavir, currently on lopinavir, currently on abacavir, duration and current use of indinavir and duration and current use of lopinavir. The D:A:D Risk Score is interpreted as low: <1%; moderate: 1-5%; high: 5-10%; and very high: >10%. The change from baseline was calculated as Week 48 minus Baseline; a positive change indicates increased risk. This Outcome Measure was added with Amendment 1 and applies only to aging participants.|Baseline and 48 weeks|The analysis set included aging participants (Prolonged Participants and Newly Enrolled Participants) who received at least one dose of raltegravir during the observation period and had evaluable results.||Percentage risk||Standard Deviation|Mean
828805|NCT01213316|Secondary|Change From Baseline in Mean Framingham Risk Score for the 10-Year Cardiovascular Risk in Aging Participants After 48 Weeks of Raltegravir Treatment|Mean Framingham Risk for 10-year cardiovascular risk was determined in aging participants (>=50 years old at initiation of raltegravir treatment). Points were allotted for each of following 8 risk factors : sex, age, systolic blood pressure, treatment for hypertension, smoking, diabetes, total cholesterol, and high-density lipoprotein. The sum of the points for each participant was assigned a percent 10-year cardiovascular risk on a lookup table, and could range from 0% to 100%. The mean Framingham Risk for 10-year cardiovascular risk was then calculated for the analysis population. The change from baseline was calculated as Baseline minus Week 48; a positive change indicates reduced risk. This Outcome Measure was added with Amendment 1 and applies only to aging participants.|Baseline and 48 weeks|The analysis set included aging participants (Prolonged Participants and Newly Enrolled Participants) who received at least one dose of raltegravir during the observation period and had evaluable results.||Percentage risk||Standard Deviation|Mean
828806|NCT01213316|Secondary|Change From Baseline in CD4+ T-cell Counts in Aging Participants After 48 Weeks of Raltegravir Treatment|Mean CD4+ T-cell counts were determined in aging participants (>=50 years old at initiation of raltegravir treatment) at baseline and after 48 weeks of raltegravir treatment was determined. A positive change from baseline indicates an increase in CD4+ T-cell count.|Baseline and 48 weeks|The analysis set included aging participants (Prolonged Participants and Newly Enrolled Participants) who received at least one dose of raltegravir during the observation period.||CD4+ T-cells/µL||Standard Deviation|Mean
828807|NCT01213316|Secondary|HIV-1 Viral Load in Aging Participants After 48 Weeks of Raltegravir Treatment|The HIV-1 viral load (log10 copies/mL of HIV-1 RNA) was determined in aging participants (>=50 years old at initiation of raltegravir treatment) at Baseline and after 48 weeks of raltegravir treatment.|Baseline and 48 weeks|The analysis set included aging participants (Prolonged Participants and Newly Enrolled Participants) who received at least one dose of raltegravir during the observation period.||Log10 Copies/mL||Standard Deviation|Mean
828808|NCT01213316|Secondary|Change From Baseline in CD4+ T-cell Counts After 96 Weeks of Raltegravir Treatment|Mean CD4+ T-cell counts were determined at baseline and after 96 weeks of raltegravir treatment. A positive change from baseline indicates an increase in CD4+ T-cell count.|Baseline and 96 weeks|The analysis set included participants in the Initial Cohort who received at least one dose of raltegravir during the observation period.||CD4+ T-cells/µL||Standard Deviation|Mean
828809|NCT01213316|Secondary|HIV-1 Viral Load After 96 Weeks of Raltegravir Treatment|The HIV-1 viral load (log10 copies/mL of HIV-1 RNA) was determined at Baseline and after 96 weeks of raltegravir treatment.|Baseline and 96 weeks|The analysis set included participants in the Initial Cohort who received at least one dose of raltegravir during the observation period.||Log10 Copies/mL||Standard Deviation|Mean
828810|NCT01213316|Secondary|Percentage of Participants With an HIV-1 Viral Load <50 Copies/mL After 96 Weeks of Raltegravir Treatment|The percentage of participants with an HIV-1 viral load <50 copies/mL of HIV-1 RNA after 96 weeks of raltegravir treatment was determined.|Baseline and 96 weeks|The analysis set included participants in the Initial Cohort who received at least one dose of raltegravir during the observation period.||Percentage of participants||95% Confidence Interval|Number
829127|NCT01216631|Secondary|Pain Visual Analogue Scale|Change in patient's assessment of pain by a 100mm visual analogue score|8 weeks||||||
828815|NCT01221272|Secondary|Exercise-induced Reversible Total Perfusion Deficit (TPD) at Baseline, End of Period 1, and End of Period 2|Exercise-induced reversible TPD was derived as the exercise TPD at baseline and at the end of Periods 1 and 2 minus the resting TPD at baseline. TPD is measured on a scale of 0-100, with higher scores being worse and lower scores being better. Measurements were obtained by SPECT imaging at baseline both at rest and following exercise and following exercise at the end of Periods 1 and 2.|Up to 33 days|Efficacy Analysis Set||units on a scale||Standard Error|Mean
828816|NCT01221272|Secondary|Exercise-induced Reversible Perfusion Defect Size (PDS) at Baseline, End of Period 1, and End of Period 2|Exercise-induced reversible PDS was derived as the exercise PDS at baseline and at the end of Periods 1 and 2 minus the resting PDS at baseline. A lower percentage means more of the myocardium is receiving blood flow. Measurements were obtained by SPECT imaging at baseline both at rest and following exercise and following exercise at the end of Periods 1 and 2.|Up to 33 days|Efficacy Analysis Set||percentage of myocardium||Standard Error|Mean
828817|NCT01221272|Secondary|Perfusion Defect Severity at Baseline, End of Period 1, and End of Period 2|Perfusion defect severity was assessed for each participant as the percentage of the 17 myocardium segments with a relative perfusion defect score of 3 or 4 on a 0-4 scale. Segment scores are: 0 = normal perfusion; 1 = mild reduction in counts-not definitely abnormal; 2 = moderate reduction in counts-definitely abnormal; 3 = severe reduction in counts; 4 = absent uptake (lower scores correspond to less severity and higher scores correspond to increased severity). A lower percentage means fewer segments have severely reduced blood flow. Measurements were obtained by SPECT imaging following exercise at baseline and at the end of Periods 1 and 2.|Up to 33 days|Efficacy Analysis Set||percentage of segments||Standard Error|Mean
828818|NCT01221272|Primary|Exercise-induced Total Perfusion Deficit (TPD) Following Ranolazine and Placebo Treatment|TPD is a score that measures the overall impact of a region of decreased myocardial blood flow, incorporating both the amount and severity of the decreased flow. TPD is measured on a scale of 0-100, with higher scores being worse and lower scores being better. Measurements were obtained by SPECT imaging following exercise at the end of the ranolazine and placebo treatment periods.|Up to 33 days|Efficacy Analysis Set||units on a scale||Standard Error|Least Squares Mean
828819|NCT01221272|Primary|Exercise-induced Perfusion Defect Size (PDS) Following Ranolazine and Placebo Treatment|PDS is the amount (percent) of the myocardium with decreased blood flow. A lower percentage means more of the myocardium is receiving blood flow. Measurements were obtained by gated single photon emission computed tomography (SPECT) imaging following exercise at the end of the ranolazine and placebo treatment periods.|Up to 33 days|Efficacy Analysis Set: 61 randomized and treated participants with data for both end-of-period (EOP) scans, completed ≥ 7 consecutive days treatment in each period, took the morning dose before each EOP scan, and had baseline perfusion defect size ≥ 5% as measured by QPS imaging software||percentage of myocardium||Standard Error|Least Squares Mean
828820|NCT01221285|Secondary|Change in IgE Fragment Antibody Binding (FAB) Activity (10 Micrograms/mL Cockroach Allergen Extract)|Outcome is the change in mean IgE fragment antibody binding (FAB) activity, baseline to post-baseline. Serum from cockroach subcutaneous immunotherapy (SCIT)-treated participants were analyzed to determine if treatment inhibits the in-vitro cockroach antigen binding to B-cells after 6-months of treatment with cockroach SCIT, using the per protocol allergenic extract doses. This result is an indicator of immune modulation over time, however its clinical significance is unclear.|Baseline through 6-months of treatment|Intent-to-treat||Percent antibody binding||Standard Error|Mean
828821|NCT01221285|Secondary|Change in German Cockroach-Specific Serum IgG4 Over Time|Outcome is the ratio of geometric means for baseline German cockroach-specific serum Immunoglobulin subclass 4 (IgG4) vs. post-baseline German cockroach-specific serum IgG4. Numerator is geometric mean post-baseline IgG4; denominator is baseline IgG4. This result is an indicator of immune modulation over time, however its clinical significance is unclear.|Baseline through 6-months of treatment|Intent-to-treat||Ratio||95% Confidence Interval|Number
828822|NCT01221285|Secondary|Change in German Cockroach-Specific Serum IgG Over Time|Outcome is the ratio of geometric means for baseline German cockroach-specific serum Immunoglobulin G (IgG) vs. post-baseline German cockroach-specific serum IgG. Numerator is geometric mean post-baseline IgG; denominator is baseline IgG.This result is an indicator of immune modulation over time, however its clinical significance is unclear.|Baseline through 6-months of treatment|Intent-to-treat||Ratio||95% Confidence Interval|Number
828823|NCT01221285|Secondary|Change in German Cockroach-Specific Serum IgE Over Time|Outcome is the ratio of geometric means for baseline German cockroach-specific serum Immunoglobulin E (IgE) vs. post-baseline German cockroach-specific serum IgE. Numerator is geometric mean post-baseline IgE; denominator is baseline IgE. This result is an indicator of immune modulation over time, however its clinical significance is unclear.|Baseline through 6-months of treatment|Intent-to-treat||Ratio||95% Confidence Interval|Number
828824|NCT01221285|Primary|Number of Reported Treatment-related Serious Adverse Events (SAEs)|Number of SAEs reported as possibly related, probably related, or definitely related to study participation.|Baseline through 6-months of treatment|Intent-to-treat||Events|||Number
828825|NCT01221285|Primary|Number of Reported Treatment-related Adverse Events (AEs)|Number of non-serious adverse events reported as possibly related, probably related, or definitely related to study participation.|Baseline through 6-months of treatment|Intent-to-treat||Events|||Number
828853|NCT01221363|Primary|Change in Objectively Measured Sitting Time From Baseline to 6 Months Follow-up|"Participants wore an ActivePAL monitor for seven days at inclusion and seven days at follow-up. The ActivePAL measures sitting time.
Change in sitting time from baseline to 6 months follow up was evaluated."|7 days of measurement / change in sitting time from baseline and 6 months follow-up|Within group difference||Hours per day||Standard Deviation|Mean
828826|NCT01221298|Secondary|Time to Virologic Relapse Through 24 Weeks Post-treatment|Time to confirmed hepatitis C virus (HCV) ribonucleic acid (RNA) ≥ lower limit of quantitation (LLOQ) (2 consecutive measurements ≥ LLOQ) at any point in the post-treatment period among participants with HCV RNA < LLOQ at the end of treatment.|Post-treatment Day 1 to Post-treatment Week 24|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT) with hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantitation (LLOQ) at the final treatment visit who completed treatment.||Days||95% Confidence Interval|Mean
828827|NCT01221298|Secondary|Time to Failure to Suppress or Rebound During Treatment|The time to failure to suppress was defined as first day a participant met any virologic stopping criteria during treatment. The virologic stopping criteria also includes failure to achieve a 2 log10 IU/mL decrease in HCV RNA by Week 1, failure to achieve HCV RNA <LLOQ by Week 6, or rebound, defined as first day of 2 consecutive increases of at least 0.5 log10 IU/mL above nadir (local minimum value) or confirmed HCV RNA > lower limit of detection (LLOD) for participants who previously achieved HCV RNA < LLOD.|Day 1 through Week 12|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).||Days||Standard Error|Mean
828828|NCT01221298|Secondary|Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) Post-Treatment|Sustained Virologic Response 24 (SVR24) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ; < 25 IU/mL) 24 weeks after the last dose of study drug.|Post-treatment Day 1 to Post-treatment Week 24|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT). Participants with missing data were imputed as failures.||percentage of participants|||Number
828829|NCT01221298|Secondary|Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment|Sustained Virologic Response 12 (SVR12) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (< LLOQ; < 25 IU/mL) 12 weeks after the last dose of study drug.|Post-treatment Day 1 to Post-treatment Week 12|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT). Participants with missing data were imputed as failures.||percentage of participants|||Number
828830|NCT01221298|Secondary|Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Below the Lower Limit of Quantitation (LLOQ) at Week 4|Analysis of percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (< 25 IU/mL).|Week 4|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT). Participants with missing data were imputed as failures.||percentage of participants|||Number
828831|NCT01221298|Secondary|Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) < 1000 International Units Per Milliliter (IU/mL)|Analysis of participants with HCV RNA levels below 1000 IU/mL at Week 2.|Week 2|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT). Participants with missing data were imputed as failures.||percentage of participants|||Number
828832|NCT01221298|Primary|Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Suppressed Below the Lower Limit of Quantitation (LLOQ) From Week 4 Through Week 12|Analysis of the percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (< 25 IU/mL).|Week 4 through Week 12|For the percentage of subjects with HCV RNA suppressed below the LLOQ from Week 4 through Week 12 out of all subjects dosed, it was assumed that if 60% of subjects were successfully suppressed from Week 4 through Week 12 then 20 subjects would give a 95% two-sided confidence interval of (36.1%, 80.9%) using binomial exact methods.||percentage of participants|||Number
828833|NCT01221311|Primary|Early Clinical Success|Early clinical success will be defined as fluoroscopic resolution at the time all stent(s) are removed. If there is a persistent stricture after 12 months of stent therapy in either group, the patient will be classified as a clinical failure. We will compare early clinical success rates in each group.|Post-stent removal (up to one year after enrollment)|The number of participants analyzed is lower than the number of patients randomized, due to patients who dropped out of the study before all stents were removed.||Participants|||Count of Participants
828834|NCT01221350|Secondary|Measurement of Quality of Life With the AQLQ (Asthma Quality of Life Questionnaire) at Endpoint|"The Asthma Quality of Life Questionnaire (AQLQ) was developed to measure the functional problems (physical, emotional, social and occupational) that are most troublesome to adults (17-70 years) with asthma.
There are 32 questions in the AQLQ and they are in 4 domains (symptoms, activity limitation, emotional function and environmental stimuli). The activity domain contains 5 ‘patient-specific’ questions. This allows patients to select 5 activities in which they are most limited and these activities will be assessed at each follow-up. Patients are asked to think about how they have been during the previous two weeks and to respond to each of the 32 questions on a 7-point scale (7 = not impaired at all - 1 = severely impaired). The overall AQLQ score is the mean of all 32 responses and the individual domain scores are the means of the items in those domains (http://www.qoltech.co.uk/aqlq.html)."|60 days|||units on a scale||Standard Deviation|Mean
828835|NCT01221350|Secondary|Measurement of Quality of Life With the AQLQ (Asthma Quality of Life Questionnaire) at Baseline|"The Asthma Quality of Life Questionnaire (AQLQ) was developed to measure the functional problems (physical, emotional, social and occupational) that are most troublesome to adults (17-70 years) with asthma.
There are 32 questions in the AQLQ and they are in 4 domains (symptoms, activity limitation, emotional function and environmental stimuli). The activity domain contains 5 ‘patient-specific’ questions. This allows patients to select 5 activities in which they are most limited and these activities will be assessed at each follow-up. Patients are asked to think about how they have been during the previous two weeks and to respond to each of the 32 questions on a 7-point scale (7 = not impaired at all - 1 = severely impaired). The overall AQLQ score is the mean of all 32 responses and the individual domain scores are the means of the items in those domains (http://www.qoltech.co.uk/aqlq.html)."|Baseline|||units on a scale||Standard Deviation|Mean
828854|NCT01221441|Secondary|Change in SF-36 General Health Assessment Questionnaire (Overall Score) From Baseline to 2 Years|Overall assessment of general health as determined by scoring use an SF-36 Questionnaire (Range 0-100 with higher scores better - indicating less disability)|2 Years|Patients with completed SF-36 questionnaire at 104 weeks||scores on a scale||95% Confidence Interval|Least Squares Mean
828855|NCT01221441|Secondary|Number of Participants With Adverse Events Due to Clinically Significant Changes in Hematology and Urinalysis Tests|The number of participants with changes in clinical hematology, chemistry, and urinalysis test results through 2 years that were considered Adverse Events|2 Years|All patients||participants|||Number
828836|NCT01221350|Secondary|Measurement of Quality of Life With the ACT (Asthma Control Test) at Endpoint|Assessment of Quality of life scores with the ACT (Asthma Control Test). The ACT is a way to determine if the asthma symptoms are well controlled. The Asthma Control Test™ (ACT™) is a five question health survey used to measure asthma control in individuals 12 years of age and older. The survey measures the elements of asthma control as defined by the National Heart, Lung, and Blood Institute (NHLBI). ACT is an efficient, reliable, and valid method of measuring asthma control, with or without, lung functioning measures such as spirometry. Each item includes 5 response options corresponding to a 5-point Likert-type rating scale. In scoring the ACT survey, responses for each of the 5 items are summed to yield a score ranging from 5 (poor control of asthma) to 25 (complete control of asthma).|60 days|||units on a scale||Standard Deviation|Mean
828837|NCT01221350|Secondary|Measurement of Quality of Life With the ACT (Asthma Control Test) at Baseline|Assessment of Quality of life scores with the ACT (Asthma Control Test). The ACT is a way to determine if the asthma symptoms are well controlled. The Asthma Control Test™ (ACT™) is a five question health survey used to measure asthma control in individuals 12 years of age and older. The survey measures the elements of asthma control as defined by the National Heart, Lung, and Blood Institute (NHLBI). ACT is an efficient, reliable, and valid method of measuring asthma control, with or without, lung functioning measures such as spirometry. Each item includes 5 response options corresponding to a 5-point Likert-type rating scale. In scoring the ACT survey, responses for each of the 5 items are summed to yield a score ranging from 5 (poor control of asthma) to 25 (complete control of asthma).|Baseline|||units on a scale||Standard Deviation|Mean
828838|NCT01221350|Secondary|Inflammatory IL-4 Sputum Levels at Endpoint|Inflammatory IL-4 sputum levels after 60 days of treatment. Sputum induction is a semi-invasive technique used to detect and monitor airway inflammation. IL-4 is a Th2 cytokine that promote airway inflammation in asthma. IL-4 drives the production of IgE in B cells. IL-4 was measured by ELISA.|60 days|||pg/mL||Standard Deviation|Mean
828839|NCT01221350|Secondary|Inflammatory Interleukin-4 (IL-4) Sputum Levels at Baseline|Inflammatory IL-4 sputum levels after 60 days of treatment. Sputum induction is a semi-invasive technique used to detect and monitor airway inflammation. IL-4 is a Th2 cytokine that promote airway inflammation in asthma. IL-4 drives the production of immunoglobulin E (IgE) in B cells. IL-4 was measured by ELISA.|Baseline|||pg/mL||Standard Deviation|Mean
828840|NCT01221350|Secondary|Induced Sputum Eosinophils at Endpoint|Eosinophils, a prominent feature of asthma, are found in increased numbers in the circulation and sputum, usually in relation to the severity of asthma.|60 days|||Eosinophil percentage in sputum cells|Participants|95% Confidence Interval|Mean
828841|NCT01221350|Secondary|Induced Sputum Eosinophils at Baseline|Eosinophils, a prominent feature of asthma, are found in increased numbers in the circulation and sputum, usually in relation to the severity of asthma.|Baseline|||Eosinophil percentage in sputum cells|Participants|95% Confidence Interval|Mean
828842|NCT01221350|Primary|Spirometric FEF Values at Endpoint|Measurement of spirometric FEF after 60 days of treatment: Forced expiratory flow (FEF) is the flow (or speed) of air coming out of the lung during the middle portion of a forced expiration.|60 days|||Liters/sec||Standard Deviation|Mean
828843|NCT01221350|Primary|Spirometric FEF Values at Baseline|Measurement of spirometric parameters at baseline: Forced expiratory flow (FEF) is the flow (or speed) of air coming out of the lung during the middle portion of a forced expiration.|Baseline|||Liters/sec||Standard Deviation|Mean
828844|NCT01221350|Primary|Spirometric FEV1 Values at Endpoint|Measurement of spirometric predicted parameters after 60 days of treatment. Forced expiratory volume in 1 second (FEV1), volume that has been exhaled at the end of the first second of forced expiration.|60 days|||Liters||Standard Deviation|Mean
828845|NCT01221350|Primary|Spirometric FEV1 Values at Baseline|Measurement of spirometric predicted parameters at baseline: Forced expiratory volume in 1 second (FEV1), volume that has been exhaled at the end of the first second of forced expiration.|Baseline|||Liters||Standard Deviation|Mean
828846|NCT01221350|Secondary|Induced Sputum Carbonylated Proteins at Endpoint|Proteins can become modified by a large number of reactions involving reactive oxygen species. Among these, carbonylation is an irreversible and unrepairable oxidative reaction. The main protein modifications originated from oxidative stress comprise direct oxidation of aminoacids with a thiol group, such as cysteine, oxidative glycation, and carbonylation. Oxidative protein carbonylation induce protein degradation in a nonspecific manner. Chemically, oxidative carbonylation preferentially occurs at proline, threonine, lysine, and arginine, presumably through a metal-catalyzed activation of hydrogen peroxide to a reactive intermediate. Carbonylation usually refers to a process that forms reactive ketones or aldehydes that can be reacted by 2,4-dinitrophenylhydrazine (DNPH) to form hydrazones. Direct oxidation of side chains of lysine, arginine, proline, and threonine residues, among other aminoacids, produces DNPH detectable protein products.|60 days|||nmol/mg||Standard Deviation|Mean
828847|NCT01221350|Primary|Spirometric FVC Values at Endpoint|Measurement of spirometric predicted parameters at the baseline and after 60 days of treatment: Forced vital capacity (FVC) is the volume of air that can forcibly be blown out after full inspiration, measured in liters.|60 days|Per protocol||Liters||Standard Deviation|Mean
828848|NCT01221350|Secondary|Induced Sputum Carbonylated Proteins at Baseline|Proteins can become modified by a large number of reactions involving reactive oxygen species. Among these, carbonylation is an irreversible and unrepairable oxidative reaction. The main protein modifications originated from oxidative stress comprise direct oxidation of aminoacids with a thiol group, such as cysteine, oxidative glycation, and carbonylation. Oxidative protein carbonylation induce protein degradation in a nonspecific manner. Chemically, oxidative carbonylation preferentially occurs at proline, threonine, lysine, and arginine, presumably through a metal-catalyzed activation of hydrogen peroxide to a reactive intermediate. Carbonylation usually refers to a process that forms reactive ketones or aldehydes that can be reacted by 2,4-dinitrophenylhydrazine (DNPH) to form hydrazones. Direct oxidation of side chains of lysine, arginine, proline, and threonine residues, among other aminoacids, produces DNPH detectable protein products|Baseline|||nmol/mg||Standard Deviation|Mean
828849|NCT01221350|Secondary|Induced Sputum of Glutathione (GSH)/Glutathione Disulfide (GSSG) Ratio at Endpoint|Change in the induced sputum of antioxidant parameters GSH and GSSG levels after 60 days of treatment. The ratio GSH/GSSG is considered an index of antioxidant status and reductive -SH groups. GSH and GSSG were measured by a microplate fluorescent assay.|60 days|||ratio||95% Confidence Interval|Mean
829128|NCT01216631|Secondary|Pain Visual Analogue Scale|Change in patient's assessment of pain by a 100mm visual analogue score|6 weeks||||||
828859|NCT01221441|Secondary|Change From Baseline in Knee Function as Determined by the Lower Extremity Functional Scale at 2 Years|Assessment of knee function as determined by the Lower Extremity Functional Scale (LEFS); change from baseline to 2 years (Range 0-80 with higher scores signifying lower difficulty in performing knee functions)|2 Years|Patients that completed 2-year follow-up||scores on a scale||95% Confidence Interval|Least Squares Mean
828860|NCT01221441|Secondary|Number of Participants With Change in Pain Severity Measured by Incidence and Dose of Analgesia|The number of participants that had a change in pain severity as measured by the incidence and dose of analgesic medications|2 Years|Patients taking at least one analgesia medication||participants|||Number
828861|NCT01221441|Secondary|Change in Pain Severity From Baseline to 2 Years as Assessed by Questionnaire|Change in pain severity (on a scale from 1 to 4) from baseline to 2 years as measured by a questionnaire (lower scores better)|2 Years|Patients that completed 2 year follow-up||scores on a scale||Standard Deviation|Mean
828862|NCT01221441|Secondary|Comparative Evaluation of Knee Magnetic Resonance Images (MRIs) From Baseline to 1 Year|Comparison of pre-procedure 3T MRI scans to those obtained at months 12 following dose administration by an independent radiographic reviewer. Evaluations will be scored using Whole Organ Magnetic Resonance imaging Score (WORMS) Cartilage Morphology Subscore (Range 0-6, with higher scores being worse)|1 Year|Patients with available baseline and 1-year MRIs||scores on a scale||95% Confidence Interval|Least Squares Mean
828863|NCT01221441|Secondary|Change From Baseline in Articular Cartilage Damage in the Knee as Determined by the Lysholm Knee Score at 2 Years|Measurement to assess outcomes of various chondral disorders of the knee determined by the Lysholm Knee Scale (Range 0-100 with higher scores better). Linear mixed model used for analysis.|2 Years|||scores on a scale||95% Confidence Interval|Least Squares Mean
828864|NCT01221441|Secondary|Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 2 Years|Symptoms, pain and functionality of the knee joint as determined by Total Score of the Knee Injury and Osteoarthritis Outcome Score (KOOS) (Range 0-100 with higher scores indicating healthier outcomes). Linear mixed model used for analysis.|2 Years|||scores on a scale||95% Confidence Interval|Least Squares Mean
828865|NCT01221441|Primary|Change From Baseline in Visual Analog Scale (VAS) Score at 1 Year|Reduction in pain as measured by a 100 mm visual analog scale (0= no pain; 100 = extreme pain) from Baseline to 1 Year. Linear mixed model used for analysis.|1 Year|Patients with available baseline and 1 year VAS score||units on a scale||95% Confidence Interval|Least Squares Mean
828866|NCT01221441|Primary|Change From Baseline in the International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score at 1 Year|Symptoms, pain and function of the knee joint determined and scored using the International Knee Documentation Committee (IKDC) Subjective Knee Evaluation (Total Score, range 0-100 with higher scores better). Linear mixed model used for analysis.|1 Year|Patients with available baseline IKDC scores||scores on a scale||95% Confidence Interval|Least Squares Mean
828867|NCT01221597|Secondary|Composite Responder Based on Change in Curvature Deformity and Change in Peyronie's Disease Bother Score|A responder was defined as a subject who satisfied the following 2 criteria at that visit: a) percent reduction from baseline in curvature deformity was ≥20% and b) reduction from baseline in PDQ Peyronie’s disease bother score was ≥1, or had a change from reporting no sexual activity at screening to reporting sexual activity.|Week 52|Efficacy analysis is based on the mITT population.||Number of participants|||Number
828868|NCT01221597|Secondary|Change From Baseline in the Penile Pain Domain of the PDQ in Subjects With Baseline Penile Pain Score ≥4|Penile pain scale range 0 (no pain) to 10 (extreme pain) on 3 questions; total score range 0 to 30. A decrease in the change from baseline total score in the penile pain domain of the PDQ is indicated by a negative number. Subjects were required to have a penile pain score of 4 or greater at baseline.|Baseline and Week 52|Efficacy analysis is based on the mITT population. This population only includes those subjects in the mITT population with a baseline penile pain score of 4 or greater.||units on a scale||Standard Deviation|Mean
828869|NCT01221597|Secondary|Change From Baseline in Penile Length|A negative value represents a reduction in measurement from baseline.|Baseline and Week 52|Efficacy analysis is based on the mITT population.||centimeters||Standard Deviation|Mean
828870|NCT01221597|Secondary|Change From Baseline in Penile Plaque Consistency|Penile plaque consistency score range 1 (non-palpable) to 5 (hard). A decrease in the change from baseline score in penile plaque consistency is indicated by a negative number.|Baseline and Week 52|Efficacy analysis is based on the mITT population.||units on a scale||Standard Deviation|Mean
828871|NCT01221597|Secondary|Change in the Overall Satisfaction Domain of the International Index of Erectile Function (IIEF)|Overall satisfaction domain of the IIEF score range 0 to 5 on 2 questions where higher scores indicate improved function or satisfaction; total score range 0 to 10.|Baseline and Week 52|Efficacy analysis is based on the mITT population.||units on a scale||Standard Deviation|Mean
828872|NCT01221597|Secondary|Change From Baseline in the Severity of Peyronie's Disease Physical and Psychological Symptoms|Peyronie's disease symptoms (physical and psychological) severity score range 0 (none) to 4 (very severe) on 6 questions; total score range 0 to 24. A decrease in the change from baseline total score in the Peyronie's disease symptoms domain of the PDQ is indicated by a negative number.|Baseline and Week 52|Efficacy analysis is based on the mITT population.||units on a scale||Standard Deviation|Mean
828873|NCT01221597|Secondary|A Responder Analysis Based on Subject Overall Global Assessment of Peyronie's Disease|A responder was defined as a subject who recorded his Peyronie’s disease had either improved in a small but important way, moderately improved, or much improved in overall global assessment question.|Week 52|Efficacy analysis was based on the mITT population.||Number of particpants|||Number
828874|NCT01221597|Primary|Change From Baseline in the Peyronie's Disease Bother Domain of the Peyronie's Disease Questionnaire (PDQ)|Peyronie's disease bother score range 0 (no issue or not at all bothered) to 4 (extremely bothered) on 4 questions; total score range 0 to 16. A decrease in the change from baseline total score in the Peyronie's disease bother domain of the PDQ is indicated by a negative number.|Baseline and Week 52|Efficacy is based on the mITT population.||units on a scale||Standard Deviation|Mean
828875|NCT01221597|Primary|Percentage Change From Baseline in Penile Curvature|A negative value in the percentage change from baseline in penile curvature deformity (angle measured in degrees) indicates less curvature.|Baseline and Week 52|Efficacy is based on the modified intent-to-treat population (mITT).||percentage of curvature change||Standard Deviation|Mean
828876|NCT01221623|Secondary|A Composite Responder Analysis Based on Change From Baseline in Penile Curvature and in the Peyronie's Disease Bother Score|"A composite responder is indicated by
a percent reduction from baseline in penile curvature greater than or equal to the threshold, and
a reduction from baseline in Peyronie's disease bother score greater than or equal to the threshold, or change in the overall sexual activity within the last 3 months to having vaginal intercourse from no vaginal intercourse at screening."|Week 52|Composite responder analysis is based on the ITT population.||participants|||Number
828877|NCT01221623|Secondary|Change From Baseline in the Penile Pain Domain of the PDQ in Subjects With Baseline Penile Pain Score ≥4|Penile pain scale range 0 (no pain) to 10 (extreme pain) on 3 questions; total score range 0 to 30. A decrease in the change from baseline total score in the penile pain domain of the PDQ is indicated by a negative number. Subjects were required to have a penile pain score of 4 or greater at baseline.|Baseline and Week 52|Efficacy is based on the mITT population; this population only includes those subjects in the mITT population with a baseline penile pain score of 4 or greater.||units on a scale||Standard Deviation|Mean
828878|NCT01221623|Secondary|Change From Baseline in Penile Length|A negative value represents a reduction in measurement from baseline.|Baseline and Week 52|Efficacy is based on the mITT population.||centimeters||Standard Deviation|Mean
828879|NCT01221623|Secondary|Change From Baseline in Penile Plaque Consistency|Penile plaque consistency score range 1 (non-palpable) to 5 (hard). A decrease in the change from baseline score in penile plaque consistency is indicated by a negative number.|Baseline and Week 52|Efficacy is based on the mITT population.||units on a scale||Standard Deviation|Mean
828880|NCT01221623|Secondary|Change in the Overall Satisfaction Domain of the International Index of Erectile Function (IIEF)|Overall satisfaction domain of the IIEF score range 0 to 5 on 2 questions where higher scores indicate improved function or satisfaction; total score range 0 to 10.|Baseline and Week 52|Efficacy is based on the mITT population.||units on a scale||Standard Deviation|Mean
828881|NCT01221623|Secondary|Change From Baseline in the Severity of Peyronie's Disease Symptoms Domain of the PDQ|Peyronie's disease symptoms (physical and psychological) severity score range 0 (none) to 4 (very severe) on 6 questions; total score range 0 to 24. A decrease in the change from baseline total score in the Peyronie's disease symptoms domain of the PDQ is indicated by a negative number.|Baseline and Week 52|Efficacy is based on the mITT population.||units on a scale||Standard Deviation|Mean
828882|NCT01221623|Secondary|A Responder Analysis Based on Subject Overall Global Assessment|Subject overall global assessment of Peyronie's disease score range -3 (much worse) to 3 (much improved). A score of 1 (improved in a small but important way), 2 (moderately improved), or 3 indicated a responder.|Week 52|Efficacy is based on the mITT population.||participants|||Number
828883|NCT01221623|Primary|Change From Baseline in the Peyronie's Disease Bother Domain of the Peyronie's Disease Questionnaire (PDQ)|Peyronie's disease bother score range 0 (no issue or not at all bothered) to 4 (extremely bothered) on 4 questions; total score range 0 to 16. A decrease in the change from baseline total score in the Peyronie's disease bother domain of the PDQ is indicated by a negative number.|Baseline and Week 52|Efficacy is based on the mITT population.||units on a scale||Standard Deviation|Mean
828884|NCT01221623|Primary|Percentage Change From Baseline in Penile Curvature|A negative value in the percentage change from baseline in penile curvature deformity (angle measured in degrees) indicates less curvature.|Baseline and Week 52|Efficacy is based on the modified intent-to-treat (mITT) population.||percentage of curvature change||Standard Deviation|Mean
828885|NCT01221727|Secondary|Ratio of PK Cmax Parameter Estimates Between Day 16 (Midazolam Only) and Day 1(Midazolam Only)|The ratio and confidence interval are calculated based on natural log scale data and converted back to the original scale.|From day 1 pre-dose to 24 hours post-dose and from day 16 pre-dose to 24 hours post-dose|The analysis set will contain all subjects from Midazolam only group for whom the primary endpoint PK parameters (AUC(0-t), AUC(0-inf) and Cmax) can be estimated for both treatment periods.||unitless|Participants|90% Confidence Interval|Least Squares Mean
828886|NCT01221727|Secondary|Summary of Percent Change From Baseline to Day 16 for Serum C-Telopeptide Concentration|This table summarizes percent change from baseline to day 16 for serum C-Telopeptide (sCTX) concentration raw values for Midazolam with Denosumab group.|Baseline (day 2 pre-dose) to day 16|Serum CTX will be collected for Midazolam with Denosumab group only. The PD analysis set will contain subjects in Midazolam with Denosumab group who received denosumab administration and for whom serum CTX concentrations are determinable on when assessed.||percentage|Participants|Inter-Quartile Range|Median
828887|NCT01221727|Primary|Ratio of PK Cmax Parameter Estimates Between Day 16 (Midazolam With the Presence of Denosumab) and Day 1 (Midazolam Only)|The ratio and confidence interval are calculated based on natural log scale data and converted back to the original scale.|From day 1 pre-dose to 24 hours post-dose and from day 16 pre-dose to 24 hours post-dose|The analysis set will contain all subjects from Midazolam with Denosumab group for whom the primary endpoint PK parameters (AUC(0-t), AUC(0-inf) and Cmax) can be estimated for both treatment periods.||unitless|Participants|90% Confidence Interval|Least Squares Mean
828888|NCT01221727|Secondary|Summary of Serum C-Telopeptide Concentration|This table summarizes serum C-Telopeptide (sCTX) concentration raw values for Midazolam with Denosumab group.|Baseline (day 2 pre-dose) to day 16|Serum CTX will be collected for Midazolam with Denosumab group only. The PD analysis set will contain subjects in Midazolam with Denosumab group who received denosumab administration and for whom serum CTX concentrations are determinable on when assessed.||ng/mL|Participants|Inter-Quartile Range|Median
828889|NCT01221727|Secondary|Summary of Serum Denosumab Concentration|This table summarizes serum Denosumab for Midazolam with Denosumab group. The Lower Limit Of Quantification (LLOQ) is 20 ng/mL. On Day 2 (pre-dose), the true value is below LLOQ, and is treated as 0 in the analysis.|Baseline (day 2 pre-dose) to day 16|Serum Denosumab will be collected for subjects in Midazolam with Denosumab group only. The analysis set will contain subjects in Midazolam with Denosumab group who received denosumab administration and for whom serum Denosumab concentrations are determinable when assessed.||ng/mL|Participants|Standard Deviation|Median
828890|NCT01221727|Secondary|Estimates of Inter- and Intra-subject Variability for PK Cmax Parameter for Midazolam Only Group|Cmax Subject denotes the inter-subject variability, while Cmax Residual denotes the intra-subject variability.|From day 1 pre-dose to 24 hours post-dose and from day 16 pre-dose to 24 hours post-dose|The analysis set will contain all subjects from Midazolam only group for whom the primary endpoint PK parameters (AUC(0-t), AUC(0-inf) and Cmax) can be estimated for both treatment periods.||ng/mL|Participants|Standard Deviation|Mean
828891|NCT01221727|Secondary|Estimates of Inter- and Intra-subject Variability for the PK AUC Parameters for Midazolam Only Group|AUC Subject denotes the inter-subject variability, while AUC Residual denotes the intra-subject variability.|From day 1 pre-dose to 24 hours post-dose and from day 16 pre-dose to 24 hours post-dose|The analysis set will contain all subjects from Midazolam only group for whom the primary endpoint PK parameters (AUC(0-t), AUC(0-inf) and Cmax) can be estimated for both treatment periods.||ng*hr/mL|Participants|Standard Deviation|Mean
828892|NCT01221727|Primary|Estimates of Inter- and Intra-subject Variability for PK Maximum Observed Plasma Concentration (Cmax) Parameter for Midazolam With Denosumab Group|Cmax Subject denotes the inter-subject variability, while Cmax Residual denotes the intra-subject variability|From day 1 pre-dose to 24 hours post-dose and from day 16 pre-dose to 24 hours post-dose|The analysis set will contain all subjects from Midazolam with Denosumab group for whom the primary endpoint PK parameters (AUC(0-t), AUC(0-inf) and Cmax) can be estimated for both treatment periods.||ng/mL|Participants|Standard Deviation|Mean
828893|NCT01221727|Primary|Estimates of Inter- and Intra-subject Variability for the PK AUC Parameters for Midazolam With Denosumab Group|AUC Subject denotes the inter-subject variability, while AUC Residual denotes the intra-subject variability|From day 1 pre-dose to 24 hours post-dose and from day 16 pre-dose to 24 hours post-dose|The analysis set will contain all subjects from Midazolam with Denosumab group for whom the primary endpoint PK parameters (AUC(0-t), AUC(0-inf) and Cmax) can be estimated for both treatment periods.||ng*hr/mL|Participants|Standard Deviation|Mean
828894|NCT01221727|Secondary|Ratio of PK AUC Parameter Estimates Between Day 16 (Midazolam Only) and Day 1(Midazolam Only)|The ratio and confidence interval are calculated based on natural log scale data and converted back to the original scale.|From day 1 pre-dose to 24 hours post-dose and from day 16 pre-dose to 24 hours post-dose|The analysis set will contain all subjects from Midazolam only group for whom the primary endpoint PK parameters (AUC(0-t), AUC(0-inf) and Cmax) can be estimated for both treatment periods.||unitless|Participants|90% Confidence Interval|Least Squares Mean
828895|NCT01221727|Primary|Ratio of Pharmcokinetic (PK) Area Under the Concentration Time Curve (AUC) Parameter Estimates Between Day 16 (Midazolam With the Presence of Denosumab) and Day 1 (Midazolam Only)|The ratio and confidence interval are calculated based on natural log scale data and converted back to the original scale.|From day 1 pre-dose to 24 hours post-dose and from day 16 pre-dose to 24 hours post-dose|The analysis set will contain all subjects from Midazolam with Denosumab group for whom the primary endpoint PK parameters (AUC(0-t), AUC(0-inf) and Cmax) can be estimated for both treatment periods.||unitless|Participants|90% Confidence Interval|Least Squares Mean
828896|NCT01221753|Secondary|4-y Overall Survival Rate|4-year overall survival rate is the percentage of patients remaining alive 4-years from study entry.|Patients were followed for survival up to 5 years from study entry. Patients alive have been followed for a mean of 55 months (range 52-60 months).|The analysis dataset is comprised of all treated patients. Since all patients have not been followed for survival for 5 years the 4-year rate is provided. All data provided was based on chart review and not from case report forms.||percentage of participants|||Number
828897|NCT01221753|Primary|2-Year Local-Regional Control Rate|2-year local-regional control rate is defined as the proportion of participants who achieve confirmed stable disease (SD) or better by 2-years post study registration based on RECIST 1.0 criteria. Per RECIST 1.0 for target lesions, complete response (CR) is disappearance of all target lesions and partial response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. Progressive disease (PD) is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started. SD is neither PR nor PD. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|Follow-up for response continued until first progression. Disease assessments occurred at completion of induction cycle 3 along with months 12, 18 and 24 post study registration.|The study was terminated early due to weak accrual. Clinical outcome data were not accessible for results reporting due to the designation of study completed at the institution.|||||
828898|NCT01221948|Secondary|Percentage of Participants With Improved, No Change or Worsened Global Impression of Change (GIC) as Compared to Baseline, Evaluated by the Neurologist.|Global Impression of Change (GIC) is a comparison to baseline and will be evaluated by rating the global impression of change using a seven-point scale: (“very much improved” to “marked worsening”). This assessment was completed by the neurologist.|52 weeks post first lead implantation|||percentage of participants|||Number
828899|NCT01221948|Primary|Mean Change in UPDRS III Score From Baseline in the Meds Off Condition (no Medications) to 26 Weeks Post First Lead Implantation in the Stim on/Meds Off Condition (Stimulation on and no Medications).|"Unified Parkinson's Disease Rating Scale Part III (UPDRS III) is the motor sub-section of the Unified Parkinson's Disease Rating scale designed to evaluate overall motor disability, including the classic symptoms of Parkinson's Disease. This section has 14 items.
Each item is scored on a scale from 0 (normal) to 4 (severe, marked, or unable), with the total possible score for the 14 items, including separate questions regarding symptoms present axially and in appendages, ranging from 0 to 108 with lower scores representing better results."|26 weeks post first lead implantation|||units on a scale||Standard Deviation|Mean
828900|NCT01221948|Secondary|Mean Percent Change in Quality of Life Scale Scores: Modified Schwab and England (SE) Scores From Baseline Meds on to 12, 26 and 52 Weeks Post First Lead Implantation Stim on/Meds on|The purpose of the Schwab and England (SE) (13) single-item scale is to quantify a PD patients’ ability to perform activities of daily living. The single item is based on a percentage rating with scores in 10% increments. Scores range from 0% (completely bed-ridden) to 100% (completely independent).|12, 26 and 52 weeks post first lead implantation|||percentage change||Standard Deviation|Mean
828901|NCT01221948|Secondary|Mean Percent Change in Quality of Life Scale Scores: Parkinson’s Disease Questionnaire (PDQ-39) From Baseline Meds on to 12, 26 and 52 Weeks Post First Lead Implantation Stim on/Meds on.|"The Parkinson's Disease Questionnaire (PDQ-39) is a 39-item questionnaire designed to measure the specific impact of PD on quality of life. The questions measure the impact on health-related quality of life along 8 dimensions:
mobility
activities of daily living
emotional well-being
stigma
social support
cognitions
communication
bodily discomfort. Dimension scores range from 0 to 100, with 0 representing perfect health for the measure and 100 representing worst health for the measure."|12, 26 and 52 weeks post first lead implantation|||percentage change||Standard Deviation|Mean
829129|NCT01216631|Secondary|US Synovitis Score|Change in US synovitis score of the affected knee at 2 and 8 weeks after treatment initiation|16 weeks||||||
828902|NCT01221948|Secondary|Mean Change in the Number of Waking Hours Per Day With Good Symptom Control and no Troublesome Dyskinesia From Baseline to 12, 26 and 52 Weeks Post First Lead Implantation.|Subjects will complete a 3-day motor diary prior to study visits. At one-hour increments (during waking hours), patients will record “on”, “on with troublesome dyskinesia”, “off”, and “asleep” times for three consecutive days.|12, 26 and 52 weeks post first lead implantation|||hours/day||Standard Deviation|Mean
828903|NCT01221948|Secondary|Mean Change in Antiparkinsonian Medication Use in Mgs (Levodopa or Equivalents) From Baseline to 12, 26 and 52 Weeks Post First Lead Implantation|All parkinsonian medications will be converted to Levodopa dose equivalents (LED)|12, 26 and 52 weeks post first lead implantation|40 completed Baseline, 35 completed Week12, 39 completed Week 26 and 38 completed Week 52||mg||Standard Deviation|Mean
828904|NCT01221948|Secondary|Mean Change in UPDRS II Score From Baseline Meds Off to 12, 26 and 52 Weeks Post First Lead Implantation Stim on/Meds Off.|"Unified Parkinson's Disease Rating Scale Part II (UPDRS II) is a sub-section of the Unified Parkinson's Disease Rating scale designed to evaluate Activities of Daily Living. This section contains 13 items.
Each item is scored on a scale from 0 (normal) to 4 (disabled), with the total score for the 13 items ranging from 0 to 52."|12, 26 and 52 weeks post first lead implantation|||units on a scale||Standard Deviation|Mean
828905|NCT01221948|Secondary|Mean Change in UPDRS III Score From Baseline Meds Off to 12 and 52 Weeks Post First Lead Implantation Stim on/Meds Off.|"Unified Parkinson's Disease Rating Scale Part III (UPDRS III) is the motor sub-section of the Unified Parkinson's Disease Rating scale designed to evaluate overall motor disability, including the classic symptoms of Parkinson's Disease. This section has 14 items.
Each item is scored on a scale from 0 (normal) to 4 (severe, marked, or unable), with the total possible score for the 14 items, including separate questions regarding symptoms present axially and in appendages, ranging from 0 to 108 with lower scores representing better results."|12 and 52 weeks post first lead implantation|||units on a scale||Standard Deviation|Mean
828906|NCT01222078|Secondary|Terminal Phase Half-life (Thalf) of Otelixizumab|Because of the early termination of the study the data was not analyzed.|Pre-dose and EOI on Dosing Day 1, EOI on Dosing Days 2, 3, 5-7 and Pre-dose, EOI, 6 hours post SOI on Dosing days 4 and 8 of each treatment course|Safety Population||hours||Full Range|Median
828907|NCT01222078|Secondary|Time of Last Observed Quantifiable Concentration (Tlast) of Otelixizumab|Because of the early termination of the study the data was not analyzed.|Pre-dose and EOI on Dosing Day 1, EOI on Dosing Days 2, 3, 5-7 and Pre-dose, EOI, 6 hours post SOI on Dosing days 4 and 8 of each treatment course|Safety Population||hours||Full Range|Median
828908|NCT01222078|Secondary|Area Under the Serum Concentration-time Curve [AUC(0-tlast)] of Otelixizumab|Because of the early termination of the study the data was not analyzed.|Pre-dose and EOI on Dosing Day 1, EOI on Dosing Days 2, 3, 5-7 and Pre-dose, EOI, 6 hours post SOI on Dosing days 4 and 8 of each treatment course|Safety Population||Hours times nanograms per milliliter||Standard Deviation|Mean
828909|NCT01222078|Secondary|Time to Cmax (Tmax) of Otelixizumab|Because of the early termination of the study the data was not analyzed.|Pre-dose and EOI on Dosing Day 1, EOI on Dosing Days 2, 3, 5-7 and Pre-dose, EOI, 6 hours post SOI on Dosing days 4 and 8 of each treatment course|Safety Population||hours||Full Range|Median
828910|NCT01222078|Secondary|Maximum Observed Serum Concentration (Cmax) of Otelixizumab|Because of the early termination of the study the data was not analyzed.|Pre-dose and EOI on Dosing Day 1, EOI on Dosing Days 2, 3, 5-7 and Pre-dose, EOI, 6 hours post SOI on Dosing days 4 and 8 of each treatment course|Safety Population||ng/mL||Standard Deviation|Mean
828911|NCT01222078|Secondary|Mean Individual Serum Concentrations of Otelixizumab|Because of the early termination of the study the data was not analyzed.|Pre-dose and EOI on Dosing Day 1, EOI on Dosing Days 2, 3, 5-7 and Pre-dose, EOI, 6 hours post SOI on Dosing days 4 and 8 of each treatment course|Safety Population||Nanograms per milliliter (ng/mL)||Standard Deviation|Mean
828912|NCT01222078|Secondary|Mean Saturation of CD3 Antigen on Peripheral Blood T Cells|Assessment of CD3 antigen was planned to be done on Day 1, 4 and 8 of first treatment course. The data was planned to be presented with unit Molecules of Equivalent Soluble Fluorochrome (MESF). Because of the early termination of the study the data was not analyzed.|Days 1, 4 and 8 of each treatment course|Safety Population||MESF||Standard Deviation|Mean
828913|NCT01222078|Secondary|Mean Circulating CD4+ and CD8+ Subset Counts|Circulating peripheral CD4+ and CD8+ T cells were planned to be measured before, during and after dose 1, 4 and 8 of first treatment course. Because of the early termination of the study the data was not analyzed.|Days 1, 4 and 8 of each treatment course|Safety Population||Percent total lymphocytes||Standard Deviation|Mean
828914|NCT01222078|Secondary|Mean Circulating Peripheral T Lymphocytes Count|Circulating peripheral T lymphocytes were planned to be measured before, during and after dose 1, 4 and 8 of first treatment course. Because of the early termination of the study the data was not analyzed.|Day 1, 4 and 8 of each treatment course|Safety Population||GI/L||Standard Deviation|Mean
828915|NCT01222078|Primary|Proportion of Anti-otelixizumab Neutralizing Antibodies|Antibodies to otelixizumab were planned to be measured at Baseline and at specified post-Baseline visits using a validated immunoassay. If a positive result was detected, the samples were analyzed further in a neutralizing antibody assay to determine if the antibodies were neutralizing. The 12 and 24 month samples were only be taken if a participant had a positive result for antibodies at the last tested time point (Month 9) or if the Month 9 test results were not available.|Up to Month 24|Safety Population. Because of the early termination of the study the data was not collected.|||||
828916|NCT01222078|Primary|Mean Serum Levels of Anti-otelixizumab Binding Antibodies|Antibodies to otelixizumab were planned to be measured at Baseline and at specified post-Baseline visits using a validated immunoassay. If a positive result was detected, the samples were analyzed further in a neutralizing antibody assay to determine if the antibodies were neutralizing. The 12 and 24 month samples were only be taken if a participant had a positive result for antibodies at the last tested time point (Month 9) or if the Month 9 test results were not available.|Up to Month 24|Safety Population. Because of the early termination of the study the data was not collected.|||||
828917|NCT01222078|Primary|Mean Change in Circulating Peripheral CD4+ and CD8+ Subset Counts|Circulating peripheral CD4+ and CD8+ T cells were planned to be measured before, during and after dose 1, 4 and 8 of first treatment course. Because of the early termination of the study the data was not analyzed.|Days 1, 4 and 8 of each treatment course|Safety Population||Percent total lymphocytes||Standard Deviation|Mean
829130|NCT01216631|Secondary|Rheumatoid Arthritis Outcome Score (RAOS)|Change in RAOS questionnaire score|2 weeks||||||
828921|NCT01222078|Primary|Mean Epstein-Barr Virus (EBV) Viral Load|Levels of EBV were assessed periodically using Quantitative Polymerase Chain Reaction. If a participant had an EBV viral load of >=10,000 copies per 10^6 Peripheral Blood Mononuclear Cells (PBMCs) at any visit, the test was repeated as soon as possible to confirm this result. If the result was confirmed, the test was repeated weekly for 2 weeks or until the count decreases to < 10,000 copies per 10^6 PBMCs, whichever was longer. The EBV Load remained zero throughout the study. Participant did not received re-dose of second treatment period and withdrew on study Day 164 because of early study termination. The viral load was to measure using unit copies per 10^6 Peripheral Blood Mononuclear Cells (PBMCs)|Up to Month 24|Safety Population||Copies per 10^6 PBMCs||Standard Deviation|Mean
828922|NCT01222078|Primary|Mean Change From Baseline in Red Blood Cell Count|Hematology parameters were planned to be analyzed from Baseline to Month 24. Day 1 value was considered to be Baseline value. Change from Baseline was planned to be calculated as any post-Baseline value minus Baseline value.|Baseline and up to Month 24|Safety Population. Because of the early termination of the study the data was not collected.|||||
828923|NCT01222078|Primary|Mean Change From Baseline in Hemoglobin Value|Hematology parameters were planned to be analyzed from Baseline to Month 24. Day 1 value was considered to be Baseline value. Change from Baseline was planned to be calculated as any post-Baseline value minus Baseline value.|Baseline and up to Month 24|Safety Population. Because of the early termination of the study the data was not collected.|||||
828924|NCT01222078|Primary|Mean Change From Baseline in Glycosylated Hemoglobin Value|Hematology parameters were planned to be analyzed from Baseline to Month 24. Day 1 value was considered to be Baseline value. Change from Baseline was planned to be calculated as any post-Baseline value minus Baseline value.|Baseline and up to Month 24|Safety Population. Because of the early termination of the study the data was not collected.|||||
828925|NCT01222078|Primary|Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and White Blood Cell Count|Hematology parameters were planned to be analyzed from Baseline to Month 24. Day 1 value was considered to be Baseline value. Change from Baseline was planned to be calculated as any post-Baseline value minus Baseline value.|Baseline and up to Month 24|Safety Population. Because of the early termination of the study the data was not collected.|||||
828926|NCT01222078|Primary|Mean Change From Baseline in Value of Estradiol|Clinical chemistry parameters were planned to be analyzed from Baseline to Month 24. Day 1 value was considered to be Baseline value. Change from Baseline was planned to be calculated as any post-Baseline value minus Baseline value.|Baseline and up to Month 24|Safety Population. Because of the early termination of the study the data was not collected.|||||
828927|NCT01222078|Primary|Mean Change From Baseline in Value of Calcium, Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Magnesium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen|Clinical chemistry parameters were planned to be analyzed from Baseline to Month 24. Day 1 value was considered to be Baseline value. Change from Baseline was planned to be calculated as any post-Baseline value minus Baseline value.|Baseline and up to Month 24|Safety Population. Because of the early termination of the study the data was not collected.|||||
828928|NCT01222078|Primary|Mean Change From Baseline in Value of Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid|Clinical chemistry parameters were planned to be analyzed from Baseline to Month 24. Day 1 value was considered to be Baseline value. Change from Baseline was planned to be calculated as any post-Baseline value minus Baseline value.|Baseline and up to Month 24|Safety Population. Because of the early termination of the study the data was not collected.|||||
828929|NCT01222078|Primary|Mean Change From Baseline in Value of Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatinine Kinase, Follicle Stimulating Hormone, Gamma Glutamyl Tranferase and Lactate Dehydrogenase|Clinical chemistry parameters were planned to be analyzed from Baseline to Month 24. Day 1 value was considered to be Baseline value. Change from Baseline was planned to be calculated as any post-Baseline value minus Baseline value.|Baseline and up to Month 24|Safety Population. Because of the early termination of the study the data was not collected.|||||
828930|NCT01222078|Primary|Mean Change From Baseline in Value of Albumin and Total Protein|Clinical chemistry parameters were planned to be analyzed from Baseline to Month 24. Day 1 value was considered to be Baseline value. Change from Baseline was planned to be calculated as any post-Baseline value minus Baseline value.|Baseline and up to Month 24|Safety Population. Because of the early termination of the study the data was not collected.|||||
828931|NCT01222078|Primary|Number of Participants With Values Outside the Normal Range for Vitals|Vital included assessment of SBP, DBP, respiration rate, heart rate and temperature were assessed at sitting position. Participant did not received re-dose of second treatment period and withdrew on study Day 164 because of early study termination.|Up to Month 24|Safety Population||Participants|||Number
828932|NCT01222078|Primary|Mean Change From Baseline in Heart Rate|Heart rate was recorded at sitting position at Baseline and post-treatment period. Day 1 value was considered to be Baseline value. Change from Baseline was planned to be calculated as any post-Baseline value minus Baseline value.|Baseline and up to Month 24|Safety Population. Because of the early termination of the study the data was not collected.|||||
828933|NCT01222078|Primary|Mean Change From Baseline in Temperature|Temperature was recorded at sitting position at Baseline and post treatment. Day 1 value was considered to be Baseline value. Change from Baseline was planned to be calculated as any post-Baseline value minus Baseline value.|Baseline and up to Month 24|Safety Population. Because of the early termination of the study the data was not collected.|||||
828934|NCT01222078|Primary|Mean Change From Baseline in Respiration Rate|Respiration rate was assessed at sitting position at Baseline and post-treatment. Day 1 value was considered to be Baseline value. Change from Baseline was planned to be calculated as any post-Baseline value minus Baseline value.|Baseline and up to Month 24|Safety Population. Because of the early termination of the study the data was not collected.|||||
828935|NCT01222078|Primary|Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Blood pressure was assessed at sitting position at Baseline and 1 to 7 hours of post-infusion of first treatment period. Day 1 value was considered to be Baseline value. Change from Baseline was planned to be calculated as any post-Baseline value minus Baseline value.|Baseline and up to Month 24|Safety Population. Because of the early termination of the study the data was not collected.|||||
829131|NCT01216631|Secondary|Psoriatic Arthritis Quality of Life Scale (PsQOL)|Change in PsQOL score from baseline|2 weeks||||||
828936|NCT01222078|Primary|Number of Participants With Any Adverse Events (AEs) and Serious AEs (SAEs)|AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE include adverse events that result in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Study was early terminated and participant withdrew on study Day 164.|Up to Month 24|Safety Population consisted of participants who had received at least one dose of infusion.||Participants|||Number
828937|NCT01222104|Secondary|Rate of Minor Vascular Complications by Presence of Peripheral Vascular Disease (PVD)|Presence of peripheral vascular disease (PVD) and its effect on minor vascular complications.|30 days|||% of procedures with minor vasc comp.|Participants||Number
828938|NCT01222104|Secondary|Rate of Major Vascular Complications (MVC) by Presence of Peripheral Vascular Disease (PVD)|Presence of peripheral vascular disease (PVD) and its effect on Major Vascular Complications (MVC).|30 days|||% of procedures with MVCs|Participants||Number
828939|NCT01222104|Secondary|Impact of Peripheral Vascular Disease (PVD) on Achieving Hemostasis by Device|Presence of peripheral vascular disease (PVD) and its effect on hemostasis. Initial hemostasis by device achieved.|30 days|||% of procedures achieving hemostasis|Participants||Number
828940|NCT01222104|Secondary|Impact of Peripheral Vascular Disease (PVD) on Use of Closure Device|Presence of peripheral vascular disease (PVD) and its effect on the decision to use a closure device|30 days|||% of procedures using closure device|Participants||Number
828941|NCT01222104|Secondary|Rate of Minor Vascular Complications by Guided Access Mode.|The influence of fluoroscopy and/or ultrasound guided access on minor vascular complications.|30 days|||% of procedures with minor vasc comp.|Participants||Number
828942|NCT01222104|Secondary|Rate of Major Vascular Complications (MVCs) by Guided Access Mode.|The influence of fluoroscopy and/or ultrasound guided access on Major Vascular Complications (MVCs).|30 days|||% of procedures with MVCs|Participants||Number
828943|NCT01222104|Secondary|Impact of Guided Access on Achieving Target Puncture Location.|The influence of fluoroscopy and/or ultrasound guided access on puncture location.|30 days|Deployed subjects with readable angiograms||% within target zone|||Number
828944|NCT01222104|Secondary|Impact of Guided Access on Use of Closure Device.|The influence of fluoroscopy and/or ultrasound guided access on the decision to use a closure device.|30 days|Percentage of procedures with devices deployed||% of procedures using a closure device|Participants||Number
828945|NCT01222104|Secondary|Rate of Minor Vascular Complications|"The following are defined as a minor vascular complication:
Unanticipated access site bleeding requiring ≥ 30 minutes of manual compression to re-achieve hemostasis;
Ipsilateral hematoma >10 cm;
Ipsilateral pseudoaneurysm without intervention;
Ipsilateral arteriovenous fistula;
Ipsilateral deep vein thrombosis;
Local access site infection without prolonged hospitalization"|30 days|||% of procedures with minor vasc comp.|Participants||Number
828946|NCT01222104|Secondary|Time to Hemostasis|Time-to-hemostasis stratified into 3 categories: hemostasis in less than 1 minute alone or in combination with manual compression (standard of care), 1-5 minutes alone or in combination with manual compression (standard of care), and/or hemostasis achieved >5 minutes and/or with additional hemostasis methods required.|Procedure|||% of procedures|Participants||Number
828947|NCT01222104|Primary|Rate of Major Vascular Complications|"Collect data on patients who have undergone a diagnostic and/or interventional radiology procedure in which the St. Jude Medical (SJM) Angio-Seal Evolution or V-Twist Integrated Platform (VIP) Device was deployed, to evaluate the rate of major vascular complications out to 30 days post-procedure.
The following are defined as a major vascular complication:
Vascular injury requiring repair via surgery, angioplasty, ultrasound guided compression, thrombin injection, or other means;
Permanent (unresolved at 30-day post-procedure evaluation) access site-related nerve injury or access site-related nerve injury requiring intervention;
Access site related bleeding requiring transfusion;
New ipsilateral lower extremity ischemia requiring surgical intervention;
Retroperitoneal bleeding;
Generalized infection requiring prolonged hospitalization and/or treatment with IV antibiotics;
Access related complication that results in extended hospital stay;
Death"|30 days|5 subjects underwent vascular closure with Angio-Seal on right and left sides.||Percentage of Procedures|Participants||Number
828948|NCT01222117|Secondary|The Incidence of Major and Minor Bleeding Events, Deaths, Adverse Events, Serious Adverse Events, and Abnormal Laboratory Values as a Measure of Safety and Tolerability.|The incidence of major and minor bleeding events, deaths, adverse events, serious adverse events, and abnormal laboratory values as a measure of safety and tolerability.|30 days|Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)||percentage of participants|||Number
828949|NCT01222117|Primary|The Proportion of Subjects With >50% Thrombolysis|The proportion of subjects with >50% thrombolysis at the end of treatment compared to baseline by arteriography.|5 hours (Treatment Groups A, B, C, G, I, M) or 2 hours (Treatment Groups D, H, J)|In groups A-D, G and H, 8 subjects were excluded (EOT arteriogram missing or not read, did not receive >=90% of dose). In groups I and J, 11 subjects were excluded (BOC not inserted/appropriately inflated, missing an arteriogram). In group F, 1 subject was not dosed and 4 subjects were excluded (did not receive >=90% of dose).||percentage of participants|||Number
828950|NCT01222195|Primary|Number of Patients With a Transfusion Independence Response|Response defined as transfusion independence (no red blood cell transfusions) for at least 8 weeks, anytime during the six 28-day cycles of therapy.|Over six 28-day cycles (approximately 168 days)|Analysis was per protocol.||participants|||Number
828951|NCT01222234|Primary|Change in 24,25(OH)2D Levels in CKD vs. Non-CKD Subjects Receiving Cholecalciferol||8 weeks of therapy|The primary comparison for this outcome of interest was between subjects taking cholecalciferol, so the calcitriol group (group 2) was excluded from the analysis. Only 15 patients per group had data analyzed for this outcome of interest; thus, the number analyzed per group differs from the enrolled numbers.||ng/ml||Standard Deviation|Mean
829132|NCT01216631|Secondary|Pain Visual Analogue Scale|Change in patient's assessment of pain by a 100mm visual analogue score|2 weeks||||||
828952|NCT01222234|Primary|Monocyte Protein Expression|Flow cytometry analysis of monocyte CD14, ACE, VDR, and Mac-1 expression|8 weeks of therapy|The primary comparison for this outcome was between only CKD groups (groups 1 and 2); therefore data from the non-CKD group (group 3) was not analyzed for this outcome. Only 15 patients per group had data analyzed for this outcome of interest; thus, the number analyzed per group differs from the enrolled numbers.||relative fluorescence units||Standard Deviation|Mean
828953|NCT01222286|Secondary|Secondary Anti-tumor Activity|"any change of M-protein in serum occurring during the study (>25 percentage increase in level of serum M-protein)
progression to active Multiple Myeloma
Definition of active Multiple Myeloma: Evidence of progression based on the IMWG criteria for progressive disease in myeloma and any one or more of the following felt related to the underlying clonal plasma cell proliferative disorder :
Development of new soft tissue plasmacytomas or bone lesions
Hypercalcemia (> 11mg/100ml)
Decrease in hemoglobin of > 2g/100ml
Rise in serum creatinine by 2 mg/100ml or more"|from start to end of study (14 months)|||Participant|||Number
828954|NCT01222286|Secondary|Pharmacodynamics of IPH2101|biological activity of IPH2101 on KIR occupancy at End of Treatment|from start to end of study (14 months)|all subjects who received at least 1 dose of IPH2101||% of occupancy of killer like receptor||Full Range|Mean
828955|NCT01222286|Secondary|Safety Assessment|adverse events, physical examination and biological changes during the whole clinical trial.|Adverse events collected from screening visit (date of signature of Inform Consent Form) up to the End of Study, up to 14 months|The safety population included all subjects who received at least 1 dose of IPH2101||Patients with any AE|||Number
828956|NCT01222286|Primary|Rate of Patients Achieving an Objective Response|The primary end point is the rate of patients achieving an objective response (defined according to the International Myeloma Working Group uniform response criteria), including minimal response, (as derived from the European Society for Blood and Marrow Transplantation criteria), achieved at any time until end of study and confirmed on two consecutive assessments at 4 weeks interval.|from start to end of study (14 months)|The ITT population included all randomized subjects.||participants|||Number
828957|NCT01222390|Primary|Breast Projection|The primary outcome of interest for this study was the change in breast projection from the time of maximum tissue expander fill volume, to 3 months after the tissue expander/implant exchange surgery. Upon final fill of the tissue expander, the breast has a certain projection. Once the fully expanded tissue expander is exchanged for the permanent implant, the patients' breast projection changes gradually over time. The change in breast projection is measured in percent change of projection from baseline (the time of the final, maximum expander fill) to 3 months after the tissue expander/implant exchange surgery (at which time a change in projection has occurred).|1.5 years|||percentage loss of projection|Participants|Standard Deviation|Mean
828958|NCT01222390|Secondary|Location of Volume Change|3-D photos will be taken to assess the location of volume and contour changes in the breast.|1.5 years||||||
828959|NCT01222390|Secondary|Emotional Outcomes|Emotional outcomes will be compared between the two groups using respective questionnaires. Questionnaires will be filled out pre-operatively, prior to implant exchange and 3 months following tissue expander/implant exchange.|1.5 years||||||
828960|NCT01222390|Secondary|Complication Rate|Complications may include hematoma, seroma, infection, implant migration, inflammation or explantation.|1.5 years||||||
828961|NCT01222390|Secondary|Aesthetic Outcomes|Aesthetic outcomes will be compared between the two groups using respective questionnaires. Questionnaires will be filled out pre-operatively, prior to implant exchange and 3 months following tissue expander/implant exchange.|1.5 years||||||
828962|NCT01222403|Primary|Number of Subjects Reporting Unsolicited Serious Adverse Events (SAEs) After Vaccination.|The number of subjects reporting any unsolicited AEs, SAEs, AEs leading to withdrawal (WD), AEs of special interest (AESI) following vaccination with Fluad_aTIV and Vantaflu_aTIV.|Day 1 through Day 28 post vaccination|Analysis was done on safety population.||Number of Subjects|||Number
828963|NCT01222403|Primary|Number of Subjects Reporting Unsolicited AEs After Vaccination.|The number of subjects reporting any unsolicited AEs following vaccination with Fluad_aTIV and Vantaflu_aTIV.|Day 1 through Day 28 post vaccination|Analysis was done on safety population.||Number of Subjects|||Number
828964|NCT01222403|Primary|Number of Subjects Reporting Solicited Adverse Events (AEs) After Vaccination.|The number of subjects reporting any solicited local and systemic AEs, following vaccination with Fluad_aTIV and Vantaflu_aTIV.|Day 1 through Day 4 after vaccination|Analysis was done on safety population ie. all subjects in the exposed set who provided postvaccination safety data.||Number of Subjects|||Number
828965|NCT01222416|Secondary|Compare and Combine Magnetic Resonance Imaging (MRIs) (Obtained From Study BRE0588) and Positron Emission Tomography/ Computed Tomography (PET/CT) Methods to Develop a Robust Assessment of Tumor Status.||48 months|There were insufficient number of patients who had both MRI and PET performed to allow for meaningful statistical comparisons.|||||
828966|NCT01222416|Primary|The Difference in the Change (Pre and End-treatment) of Standard Uptake Value (SUV) Between Pathological Non-responders and Responders (pCR)|The quantitative measures of standard uptake value (SULpeak and SULmax, prone and supine position) from PET were obtained. SUV = (Tracer activity in tissue)/(Injected radiotracer dose/patient weight or lean body mass) with unit microcuries/g/(millicuries/kg) (no unit after simplification). The SUV was averaged over the tumor regions. These averages were computed for each patient at each time point. All patients were were planned to be scanned three times: prior to treatment, during treatment and at the end of treatment. The change of SUV was calculated as the end of treatment value minus the pre-treatment value. Then the difference in the change between the responders and non-responders were estimated using Wilcoxon rank sum test. The pseudomedians and nonparametric confidence intervals for the difference (change of non-responders minus the change of responders) were reported for parameters SULpeak and SULmax measured for different positions. Pathological response were measured at the|up to 6 months (1 scan prior to chemotherapy and 2 scans prior to surgery)|19 Patients had the scanned data at two time points: prior treatment and at the end of treatment.||microcuries/g/(millicuries/kg)||95% Confidence Interval|Median
828997|NCT01222533|Secondary|FEV1 Area Under the Curve 0 to 6 Hours (AUC0-6h) at the End of Each Treatment Period|FEV1 AUC0-6h calculated from zero time to 6 hours using the trapezoidal rule divided by 6 hours. Trough FEV1 will be assigned to zero time. Means are adjusted for sequence, patients within sequences, period and treatment.|4 weeks|FAS with imputed data.||Liter||Standard Error|Mean
829133|NCT01216631|Secondary|US Synovitis Score|Change in US synovitis score of the affected knee at 2 and 8 weeks after treatment initiation|2 weeks||||||
828967|NCT01222507|Primary|Brain Speed Test|This test involves the presentation of two consecutive high or low-frequency sound sweeps that requires the participant to correctly identify the order of presentation of the sound sweeps. Correct identification of the sound sweeps requires intact brain processing speed and attention. Scores are presented relative to age-matched controls used in validating the test. The normative data for the controls for this test will be provided by Posit Science® to the PI.|Initial study visit|The number of subjects who completed the study according to protocol.||units on a scale||95% Confidence Interval|Median
828968|NCT01222520|Secondary|Seated Blood Pressure (BP) Normalisation at Trough|Seated blood pressure (BP) normalisation: The numbers of patients whose blood pressure was within normalisation criterion in terms of seated blood pressure after the 8-week double-blind period At trough: 24-hour post-dosing|8 weeks|FAS||Participants|||Number
828969|NCT01222520|Secondary|Seated SBP Response Rate at Trough|SBP response rate: The rate of patients who achieved an adequate response in seated SBP at trough (<140 mmHg and/or reduction from reference baseline ≥20 mmHg) after the 8-week double-blind period At trough: 24-hour post-dosing|8 weeks|FAS||Percentage of participants|||Number
828970|NCT01222520|Secondary|Seated DBP Response Rate at Trough|DBP response rate: The rate of patients who achieved an adequate response in seated DBP at trough (<90 mmHg and/or reduction from reference baseline ≥10 mmHg) after the 8-week double-blind period At trough: 24-hour post-dosing|8 weeks|FAS||Percentage of participants|||Number
828971|NCT01222520|Secondary|Seated SBP Control Rate at Trough|SBP control rate: The rate of patients with controlled seated SBP at trough of less than 140 mmHg after the 8-week double-blind period At trough: 24-hour post-dosing|8 weeks|Patients included in FAS and with seated SBP ≥140 mmHg at reference baseline||Percentage of participants|||Number
828972|NCT01222520|Secondary|Seated DBP Control Rate at Trough|DBP control rate: The rate of patients with controlled seated DBP at trough of less than 90 mmHg after the 8-week double-blind period At trough: 24-hour post-dosing|8 weeks|FAS||Percentage of participants|||Number
828973|NCT01222520|Secondary|Reduction From the Reference Baseline in Mean Seated Systolic Blood Pressure (SBP) at Trough|Reference baseline: Status of patients after the 8-week open-label run-in period with telmisartan monotherapy, where patients' eligibility to enter the double-blind treatment period was examined At trough: 24-hour post-dosing|Baseline, 8 weeks|FAS||mmHg||Standard Error|Least Squares Mean
828974|NCT01222520|Primary|Reduction From the Reference Baseline in Mean Seated Diastolic Blood Pressure (DBP) at Trough|Reference baseline: Status of patients after the 8-week open-label run-in period with telmisartan monotherapy, where patients' eligibility to enter the double-blind treatment period was examined At trough: 24-hour post-dosing|Baseline, 8 weeks|Full analysis set (FAS)||mmHg||Standard Error|Least Squares Mean
828975|NCT01222533|Other Pre-specified|VPB Singles|"The outcome measure describes the number of patients with a Ventricular Premature Beat (VPB) single evaluated over the entire 6.5 h Holter monitoring period. The arrhythmia variables were pre-specified for day 29 and analysed post-hoc for day 26. The lines Day 29 1st h and Day 26 1st h are related to the interval 0 h to 1 h, i.e. the first hour after dosing."|6.5 hours (including pre dose)|ECGFAS - including all patients in the treated set for whom continuous 12 lead ECGs (Holter monitoring) were recorded on at least one occasion (pacemaker patients were excluded)||participants|||Number
828976|NCT01222533|Other Pre-specified|VPB Pairs|"The outcome measure describes the number of patients with a Ventricular Premature Beat (VPB) pair evaluated over the entire 6.5 h Holter monitoring period. Pairs were defined as 2 consecutive premature beats in a row. The arrhythmia variables were pre-specified for day 29 and analysed post-hoc for day 26. The lines Day 29 1st h and Day 26 1st h are related to the interval 0 h to 1 h, i.e. the first hour after dosing."|6.5 hours (including pre dose)|ECGFAS - including all patients in the treated set for whom continuous 12 lead ECGs (Holter monitoring) were recorded on at least one occasion (pacemaker patients were excluded)||participants|||Number
828977|NCT01222533|Other Pre-specified|VPB Runs|"The outcome measure describes the number of patients with a Ventricular Premature Beat (VPB) run evaluated over the entire 6.5 h Holter monitoring period. Runs were defined as at least 3 premature beats in a row. The arrhythmia variables were pre-specified for day 29 and analysed post-hoc for day 26. The lines Day 29 1st h and Day 26 1st h are related to the interval 0 h to 1 h, i.e. the first hour after dosing."|6.5 hours (including pre dose)|ECGFAS - including all patients in the treated set for whom continuous 12 lead ECGs (Holter monitoring) were recorded on at least one occasion (pacemaker patients were excluded)||participants|||Number
828978|NCT01222533|Other Pre-specified|VPB Total|"The outcome measure describes the number of patients with a Ventricular Premature Beat (VPB) event evaluated over the entire 6.5 h Holter monitoring period. The arrhythmia variables were pre-specified for day 29 and analysed post-hoc for day 26. The lines Day 29 1st h and Day 26 1st h are related to the interval 0 h to 1 h, i.e. the first hour after dosing."|6.5 hours (including pre dose)|ECGFAS - including all patients in the treated set for whom continuous 12 lead ECGs (Holter monitoring) were recorded on at least one occasion (pacemaker patients were excluded)||participants|||Number
828979|NCT01222533|Other Pre-specified|SVPB Singles|"The outcome measure describes the number of patients with a Supraventricular Premature Beat (SVPB) single evaluated over the entire 6.5 h Holter monitoring period. The arrhythmia variables were pre-specified for day 29 and analysed post-hoc for day 26. The lines Day 29 1st h and Day 26 1st h are related to the interval 0 h to 1 h, i.e. the first hour after dosing."|6.5 hours (including pre dose)|ECGFAS - including all patients in the treated set for whom continuous 12 lead ECGs (Holter monitoring) were recorded on at least one occasion (pacemaker patients were excluded)||participants|||Number
828980|NCT01222533|Other Pre-specified|SVPB Pairs|"The outcome measure describes the number of patients with a Supraventricular Premature Beat (SVPB) pair evaluated over the entire 6.5 h Holter monitoring period. Pairs were defined as 2 consecutive premature beats in a row. The arrhythmia variables were pre-specified for day 29 and analysed post-hoc for day 26. The lines Day 29 1st h and Day 26 1st h are related to the interval 0 h to 1 h, i.e. the first hour after dosing."|6.5 hours (including pre dose)|ECGFAS - including all patients in the treated set for whom continuous 12 lead ECGs (Holter monitoring) were recorded on at least one occasion (pacemaker patients were excluded)||participants|||Number
829096|NCT01216397|Secondary|Metformin: AUC0-infinity|Geometric Mean of AUC0-infinity of Metformin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
828981|NCT01222533|Other Pre-specified|SVPB Runs|"The outcome measure describes the number of patients with a Supraventricular Premature Beat (SVPB) run evaluated over the entire 6.5 h Holter monitoring period. Runs were defined as at least 3 premature beats in a row. The arrhythmia variables were pre-specified for day 29 and analysed post-hoc for day 26. The lines Day 29 1st h and Day 26 1st h are related to the interval 0 h to 1 h, i.e. the first hour after dosing."|6.5 hours (including pre dose)|ECGFAS - including all patients in the treated set for whom continuous 12 lead ECGs (Holter monitoring) were recorded on at least one occasion (pacemaker patients were excluded)||participants|||Number
828982|NCT01222533|Other Pre-specified|SVPB Total|"The outcome measure describes the number of patients with a Supraventricular Premature Beat (SVPB) event evaluated over the entire 6.5 h Holter monitoring period. The arrhythmia variables were pre-specified for day 29 and analysed post-hoc for day 26. The lines Day 29 1st h and Day 26 1st h are related to the interval 0 h to 1 h, i.e. the first hour after dosing."|6.5 hours (including pre dose)|ECGFAS - including all patients in the treated set for whom continuous 12 lead ECGs (Holter monitoring) were recorded on at least one occasion (pacemaker patients were excluded)||participants|||Number
828983|NCT01222533|Other Pre-specified|Mean Heart Rate (HR)|"Mean HR evaluated over the entire 6.5 h Holter monitoring period. The arrhythmia variables were pre-specified for day 29 and analysed post-hoc for day 26. The lines Day 29 1st h and Day 26 1st h are related to the interval 0 h to 1 h, i.e. the first hour after dosing."|6.5 hours (including pre dose)|ECGFAS - including all patients in the treated set for whom continuous 12 lead ECGs (Holter monitoring) were recorded on at least one occasion (pacemaker patients were excluded)||bpm||Standard Deviation|Mean
828984|NCT01222533|Other Pre-specified|Maximum Heart Rate (HR)|"Maximum HR evaluated over the entire 6.5 h Holter monitoring period. The arrhythmia variables were pre-specified for day 29 and analysed post-hoc for day 26. The lines Day 29 1st h and Day 26 1st h are related to the interval 0 h to 1 h, i.e. the first hour after dosing."|6.5 hours (including pre dose)|ECGFAS - including all patients in the treated set for whom continuous 12 lead ECGs (Holter monitoring) were recorded on at least one occasion (pacemaker patients were excluded).||bpm||Standard Deviation|Mean
828985|NCT01222533|Secondary|Minimum Plasma Concentration at Steady-state (Cmin,ss)|Cmin,ss is the minimum measured concentration of tiotropium in plasma at steady-state.|Based on blood sampling for PK assessments done at 4 weeks at the following time points: 5 min before first dosing of study drug (baseline) and at 2 min , 5 min, 7 min, 9 min, 12 min, 15 min, 20 min, 30 min, 40 min, 1 h, 2 h, 4 h and 6 h post dosing.|PK Set. All patients with analysable data.||pg/mL||Geometric Coefficient of Variation|Geometric Mean
828986|NCT01222533|Secondary|Renal Clearance at Steady-state (CL R,0-6h,ss)|Renal clearance of the drug over the time interval 0 to 6 hours at steady-state. CL R,0-6h,ss was calculated as the quotient of Ae0-6h,ss and AUC0-6h,ss.|Based on blood and urine sampling for PK assessments done at 4 weeks over 6 h post dosing.|PK Set. All patients with analysable data.||mL/min||Geometric Coefficient of Variation|Geometric Mean
828987|NCT01222533|Secondary|Pre-dose Plasma Concentration at Steady-state (Cpre,ss)|Cpre,ss is the measured concentration of tiotropium in plasma before dosing at steady-state.|Based on blood sampling for PK assessments done at 4 weeks at the following time point: 5 minutes (min) before first dosing of study drug (baseline)|PK Set. All patients with analysable data.||pg/mL||Geometric Coefficient of Variation|Geometric Mean
828988|NCT01222533|Secondary|Amount of Drug Eliminated in Urine at Steady-state (Ae0-6h,ss)|Total quantity of the analyte that is excreted in urine over the time interval 0 to 6 hours at steady state.|Based on urine sampling for PK assessments done at 4 weeks in the following intervals: -1 to 0 hour (h), 0 to 2 h and 2 to 6 h post-dosing.|PK Set. All patients with analysable data.||ng||Geometric Coefficient of Variation|Geometric Mean
828989|NCT01222533|Secondary|Time to Maximum Plasma Concentration at Steady-state (Tmax,ss)|Tmax,ss is the time from dosing to the maximum concentration of tiotropium in plasma-venous blood at steady-state.|Based on blood sampling for PK assessments done at 4 weeks at the following time points: 5 min before first dosing of study drug (baseline) and at 2 min , 5 min, 7 min, 9 min, 12 min, 15 min, 20 min, 30 min, 40 min, 1 h, 2 h, 4 h and 6 h post dosing.|PK Set. All patients with analysable data.||hours||Full Range|Median
828990|NCT01222533|Secondary|Area Under the Curve 0 to 1 Hour at Steady-state (AUC0-1h,ss)|AUC0-1h,ss is the area under the concentration time curve of tiotropium in plasma over the time interval 0 to 1 hour post-dose at steady-state. AUC0-1h,ss was calculated using the linear up/log down algorithm.|Based on blood sampling for PK assessments done at 4 weeks at the following time points: 5 minutes (min) before study drug (baseline) and at 2 min , 5 min, 7 min, 9 min, 12 min, 15 min, 20 min, 30 min, 40 min, 1 hour (h), 2 h, 4 h and 6 h post dosing.|PK Set. All patients with analysable data.||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
828991|NCT01222533|Secondary|FVC at Each Planned Time at the End of Each Treatment Period|Means are adjusted for period, planned time, period*planned time, patient*planned time and patient*treatment*planned time.|4 weeks|FAS with imputed data. One patient with missing FVC data in Placebo and Tio R2.5 period.||Liter||Standard Error|Mean
828992|NCT01222533|Secondary|FEV1 at Each Planned Time at the End of Each Treatment Period|Means are adjusted for period, planned time, period*planned time, patient*planned time and patient*treatment*planned time.|4 weeks|FAS with imputed data.||Liter||Standard Error|Mean
828993|NCT01222533|Secondary|FVC AUC0-3h at the End of Each Treatment Period|FVC AUC0-3h calculated from zero time to 3 hours using the trapezoidal rule divided by 3 hours. Trough FVC will be assigned to zero time. Means are adjusted for sequence, patients within sequences, period and treatment.|4 weeks|FAS with imputed data. One patient with missing FVC data in Placebo and Tio R2.5 period.||Liter||Standard Error|Mean
828994|NCT01222533|Secondary|FVC AUC0-6h at the End of Each Treatment Period|FVC AUC0-6h calculated from zero time to 6 hours using the trapezoidal rule divided by 6 hours. Trough FVC will be assigned to zero time. Means are adjusted for sequence, patients within sequences, period and treatment.|4 weeks|FAS with imputed data. One patient with missing FVC data in Placebo and Tio R2.5 period.||Liter||Standard Error|Mean
828995|NCT01222533|Secondary|Trough Forced Vital Capacity (FVC) at the End of Each Treatment Period|Defined as the pre-dose FVC measured just prior to the last administration of the morning dose of the randomised treatment. Means are adjusted for sequence, patients within sequences, period and treatment.|4 weeks|FAS with imputed data. One patient with missing FVC data in Placebo and Tio R2.5 period.||Liter||Standard Error|Mean
829097|NCT01216397|Primary|Metformin: AUC0-tz|Geometric Mean of AUC0-tz of Metformin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
828998|NCT01222533|Secondary|Trough Forced Expiratory Volume in One Second (FEV1) at the End of Each Treatment Period|Defined as FEV1 measured just prior to the last administration of the morning dose of the randomised treatment. Means are adjusted for sequence, patients within sequences, period and treatment.|4 weeks|Full analysis set (FAS) with imputed data. FAS includes all patients in the treated set who have analysable data for at least one efficacy endpoint during the relevant crossover period.||Liter||Standard Error|Mean
828999|NCT01222533|Primary|Area Under the Curve 0 to 6 Hours at Steady-state (AUC0-6h,ss)|AUC0-6h,ss is the area under the concentration time curve of tiotropium in plasma over the time interval 0 to 6 hours post-dose at steady-state. AUC0-6h,ss was calculated using the linear up/log down algorithm.|Based on blood sampling for PK assessments done at 4 weeks at the following time points: 5 minutes (min) before study drug (baseline) and at 2 min , 5 min, 7 min, 9 min, 12 min, 15 min, 20 min, 30 min, 40 min, 1 hour (h), 2 h, 4 h and 6 h post dosing.|PK Set. No PK data for Placebo. The low number of non-missing AUC0-6h,ss results for the Tio R 1.25 and Tio R 2.5 cohorts is due to the exclusion of results below the limit of quantification.||pg*h/ml||Geometric Coefficient of Variation|Geometric Mean
829000|NCT01222533|Primary|Maximum Plasma Concentration at Steady-state (Cmax,ss)|Cmax,ss is the maximum measured concentration of tiotropium in plasma at steady-state.|Based on blood sampling for PK assessments done at 4 weeks at the following time points: 5 minutes (min) before study drug (baseline) and at 2 min , 5 min, 7 min, 9 min, 12 min, 15 min, 20 min, 30 min, 40 min, 1 hour (h), 2 h, 4 h and 6 h post dosing.|Pharmacokinetic (PK) Set. This analysis set includes all patients in the treated set who had at least one blood sample drawn or one urine sample collected for PK analysis. Patients with an important protocol violation relevant to the PK population were excluded. No PK data for placebo. All patients with analysable data.||pg/ml||Geometric Coefficient of Variation|Geometric Mean
829001|NCT01222572|Primary|Maximum Tolerated Dose (MTD)|"The MTD is determined by the number of patients who experience a dose limiting toxicity (DLT). The MTD is defined as the highest dose at which fewer than one-third of patients experience a DLT. If no DLTs are observed, the MTD is not reached.
DLTs were defined as follows (CTCAE v4.0):
Grade 2 non-hematologic toxicities: Myelitis; Esophageal fistula, perforation, hemorrhage
Grade 3 non-hematologic toxicities considered to be a direct result of therapy:
Radiation pneumonitis; Pericarditis, pericardial effusion, pericardial tamponade; Esophageal necrosis, stenosis, ulcer; Dyspnea; Myelitis Grade 4 non-hematologic toxicities: Radiation pneumonitis; Pericarditis, pericardial effusion, pericardial tamponade; Esophagitis (not due to mediastinal irradiation unrelated to the stereotactic boost), esophageal necrosis, stenosis, ulcer; Dyspnea; Myelitis Grade 5 non-hematologic toxicity: Any"|7-week chemoradiotherapy period and the subsequent 8-week recovery period|All treated participants who received at least one dose of the study drug and were evaluable for DLT.||participants with DLT|||Number
829002|NCT01222585|Primary|Volume of Distribution|Volume of Distribution (L/kg)|2-5 days of study drug administration|The PK analysis was conducted using samples from 23 subjects. One subject died soon after the loading dose and was excluded from the analysis. Two subjects had no multiple dose samples. Thus data from 20 subjects were used to estimate the PK parameter.||L/kg||Full Range|Median
829003|NCT01222585|Primary|Clearance|Clearance (L/h/kg)|2-5 days of study drug administration|The PK analysis was conducted using samples from 23 subjects. One subject died soon after the loading dose and was excluded from the analysis. Two subjects had no multiple dose samples. Thus data from 20 subjects were used to estimate the PK parameter.||L/h/kg||Full Range|Median
829004|NCT01222585|Primary|Multiple Dose Minimum Concentration|Multiple Dose Minimum Concentration (mg/L)|2-5 days of study drug administration|The sample size contains the number of subjects that had the sample of interest collected.||mg/L||Full Range|Median
829005|NCT01222585|Primary|Multiple Dose Maximum Concentration|Multiple Dose Maximum Concentration (mg/L)|2-5 days of study drug administration|The PK analysis was conducted using samples from 23 subjects. One subject died soon after the loading dose and was excluded from the analysis. Two subjects had no multiple dose samples. Thus data from 20 subjects were used to estimate the multiple dose PK parameter.||mg/L||Full Range|Median
829006|NCT01222585|Primary|Loading Dose Minimum Concentration|Loading Dose Minimum Concentration (mg/L)|2-5 days of study drug administration|The sample size contains the number of subjects that had the sample of interest collected.||mg/L||Full Range|Median
829007|NCT01222585|Primary|Loading Dose Maximum Concentration|Loading Dose Maximum concentration (Cmax)|2-5 days of study drug administration|The sample size contains the number of subjects that had the sample of interest collected.||mg/L||Full Range|Median
829008|NCT01222585|Primary|Area Under the Curve at Steady State|Area under the curve at steady state (AUCss)|pre-dose: 30 min; post-dose:10 min, 3-4,6-8, 12-13, 24-25, 36-37, 48-49, 72-73 hours post dose|The PK analysis was conducted using samples from 23 subjects. One subject died soon after the loading dose and was excluded from the analysis. Two subjects had no multiple dose samples. Thus data from 20 subjects were used to estimate this PK parameter.||mg*hr/L||Full Range|Median
829009|NCT01222689|Secondary|Number of Patients With Dose Modifications and Reason for Dose Modification.|Tabulation of the reasons for dose modification with number of patients|Up to final day of study treatment|Numbers in tabulation total to more than 18 because patients often had 2 or more reasons that prompted dose reduction. For example: Nausea/Vomiting + diarrhea (3), fatigue + diarrhea (2), rash + hypertension (1), rash + diarrhea (1), fatigue + Nausea/Vomiting (1)||participants|||Number
829010|NCT01222689|Primary|Survival at 24 Weeks|Percent survival at 24 weeks (6 months)|24 weeks|||percentage of participants|||Number
829011|NCT01222689|Other Pre-specified|Plasma Biomarkers Potentially Predictive of Dual MEK/EGFR Inhibition|"The association between candidate plasma biomarkers of interest, their longitudinal changes, and patient outcomes as measured by OS, PFS, and radiographic and biomarker response.
Specifically, correlation of the relative change in allelic frequency of mutations present in both pre-treatment and on-treatment blood samples versus percent change in CA19-9."|Up to 2 years|Patients who had non-germline mutations (circulating cell-free DNA) represented in both their pre-treatment blood and on-treatment blood samples.||R^2|||Number
829098|NCT01216397|Primary|Metformin: Cmax|Geometric Mean of Cmax of Metformin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
829099|NCT01216397|Secondary|Linagliptin: Apparent Volume of Distribution During the Terminal Phase Following an Extravascular Dose (Vz/F)|Geometric mean of the Vz/F of linagliptin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set||Liter||Geometric Coefficient of Variation|Geometric Mean
829012|NCT01222689|Other Pre-specified|Circulating Tumor Cell (CTC) Analysis|The association between baseline CTC numbers, their longitudinal changes, and patient outcomes as measured by OS, PFS, and radiographic and biomarker response will be evaluated. The association between expression level of protein markers in CTC with biopsy samples using Pearson's correlation and by unsupervised hierarchical clustering of samples using Pearson correlation as the distance metric will be assessed. Association of longitudinal protein markers in CTC with patient OS will be evaluated using the joint models of longitudinal observations.|Up to 2 years|Data was not collected.|||||
829013|NCT01222689|Other Pre-specified|Protein Expression Levels in Pretherapeutic Core Biopsies|Logistic regression models will be used to associate baseline protein markers and best objective response. Cox models will be used to associate baseline protein markers with overall and progression-free survival. Each selected protein markers will be evaluated individually and ranked by the corresponding p-values. Combinations of markers will also be explored.|Up to 2 years|Data was not collected.|||||
829014|NCT01222689|Secondary|Incidence of Toxicities Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0|Tabulation of type of adverse events (AE) and the incidence of grade 3 and 4 for each AE|Up to 30 days after completion of study treatment|||events|||Number
829015|NCT01222689|Secondary|Objective Radiographic Response by RECIST Criteria|"Patient's best overall response will be tabulated by level; proportions of complete response (CR) and of CR+partial response will be calculated along with 95% confidence intervals.
Per Response Evaluation Criteria In Solid Tumors (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR, >= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR+PR."|Up to 2 years|There were no complete or patial responses by RECIST (stable disease, partial response, or complete response) amongst the 46 participants||participants|||Number
829016|NCT01222689|Secondary|CA19-9 Biomarker Response (Defined as a 50% Decline in Serum CA19-9 Level From Baseline in Patients With > 2 x ULN CA19-9 Measurement)|The proportion of patients with CA19-9 response.|Up to 2 years|Patients with baseline levels > 2 x ULN CA19-9 measurement||percentage of participants|||Number
829017|NCT01222689|Secondary|Progression-free Survival (PFS)|"Calculated according to the method of Kaplan and Meier. Actual and estimated probability of being alive and progression-free, along with a 95% confidence interval, will be calculated.
Response and progression are evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(Macdonald et al.):205-216, 2000]. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used. Progressive Disease is defined as a 20% or higher increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions)."|From first dose of study treatment to the date of objective progression, or death due to cancer or unknown cause, or to the date of withdrawal from the trial from unknown reasons, assessed up to 2 years|||months||95% Confidence Interval|Median
829018|NCT01222689|Primary|Overall Survival (OS)|Survival will be calculated according to the method of Kaplan and Meier. Both actual and estimated probability of being alive (along with a 95% confidence interval) at 24 weeks (6 months) and for any multiple of 6 months will be calculated for which the number of uncensored subjects is not smaller than 10.|Up to 2 years|||months||95% Confidence Interval|Median
829019|NCT01222715|Other Pre-specified|Progression-free Survival|Progression-free survival data will be explored using Kaplan Meier analysis. Associations between this outcome and each of the biomarkers will be investigated using univariate Cox proportional hazards regression analysis.|Up to 5 years||||||
829020|NCT01222715|Other Pre-specified|Levels of Biomarkers Related to the Effect of Temsirolimus on the Unfolded Protein Response||Up to 36 weeks||||||
829021|NCT01222715|Other Pre-specified|Clinical Response|The data reported in 2 groups will be summarized using numbers and percentages of patients in each stratum and at each time point (baseline, after course 2, at the time of best response and end of therapy or progressive disease, whichever comes first). A binomial generalized estimating equation (GEE) model will be fitted to the data. The variables in the model will be time, treatment group and a biomarker. The beta coefficient of the biomarker will quantify the strength of the association between clinical response and the biomarker, beyond the association of the outcome to the other variables.|Up to 5 years||||||
829022|NCT01222715|Other Pre-specified|Clinical Predictors, Including Histologic and Molecular Subtype, Age, Stage, and Site|These known risk factors will be compared to genomic features like gene and ribonucleic acid (RNA) expression values, as well as combinations of the two and splice variants of known genes, in order to identify those features most related to treatment resistance and poor outcome (overall survival and failure-free survival) using a Cox proportional hazards model of gene expression with cross validation.|Up to 5 years||||||
829023|NCT01222715|Other Pre-specified|Changes in Angiogenesis-associated Plasma Markers Between Patients by Treatment|First, the distributions of these markers will be compared at ‘end of 2 cycles’ between treatments using a 2-independent sample non-parametric test. The mean will also be modeled for each of these markers (or a transformation of the marker to near normality) as a function of time and treatment using GEEs which are designed to take into account the internal correlation of repeated measurements taken on the same subject. Associations between progression-free survival and changes in each of the biomarkers will be investigated using univariate Cox proportional hazards regression analysis.|Baseline up to day 42||||||
829024|NCT01222715|Other Pre-specified|Biomarker Levels|Biomarker data will be summarized for each response category, at each time point using either means and standard deviations or medians and ranges.|Up to 36 weeks||||||
829025|NCT01222715|Secondary|Response Rate (CR + PR)|Complete or partial anatomical response rate. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Overall Response (OR) = CR + PR.|From the date of randomization until a maximum of 2 cycles (21 days per cycle) of treatment in the absence of disease progression or unacceptable toxicities.|Only eligible participants with overall response evaluated were analyzed.||Proportion of participants||95% Confidence Interval|Number
829026|NCT01222715|Primary|Rate of Dose-Limiting Toxicities|The following events will be considered dose-limiting toxicities (DLTs): Toxicity causing delays > 14 days in delivery of a 21-day cycle of therapy; Grade ≥ 3 mucositis > 3 days duration; Grade ≥ 3 thromboembolic events; Grade ≥ 3 bleeding events; Grade ≥ 3 pulmonary events; Grade ≥ 3 hypertension; Grade 3 hyperglycemia (uncontrolled); Grade ≥ 4 hyperglycemia; Grade ≥ 4 hyperlipidemia (including cholesterol and triglycerides) that does not return to ≤ Grade 2 levels with appropriate medical management within 35 days; Grade ≥ 2 perforation including fistula or leak (gastrointestinal or any other organ); Grade ≥ 3 proteinuria; Grade ≥ 3 cardiac toxicity; Grade ≥ 3 intra-abdominal abscess/infection; Grade ≥ 3 wound complication (wound infection or dehiscence); Grade ≥ 1 Reversible Posterior Leukoencephalopathy Syndrome (RPLS); Grade ≥ 1 Microangiopathy, or Hemolytic-uremic syndrome (HUS) or Thrombotic thrombocytopenic Purpura (TTP).|From the date of randomization until a maximum of 12 cycles (21 days per cycle) of treatment in the absence of disease progression or unacceptable toxicities.|Only eligible participants were analyzed.||Percentage of participants||95% Confidence Interval|Number
829027|NCT01222715|Primary|Event Free Survival Probability|Probability of no relapse, secondary malignancy, or death after 1 year in the study.|1 year|Only eligible participants were analyzed.||Probability||95% Confidence Interval|Number
829028|NCT01222832|Primary|Rate of Infection|Number of participants without infections on post-op visits 90 days.|90 days|||Participants|||Count of Participants
829029|NCT01222884|Secondary|Change in Hemoglobin Concentration||6 weeks|The FAS population included all subjects who were randomised into the study, received at least one dose of the study drug, and had a Hb assessment. Subjects were included as randomised, regardless of which treatment they actually received.||g/dL||Full Range|Mean
829030|NCT01222884|Primary|Ability to Maintain Hemoglobin Level|The primary outcome measure was the proportion of subjects who were able to maintain haemoglobin between 9.5 and 12.5 g/dL (both values included) at week 6. Haemoglobin was measured by a blood sample at the different visits. All blood samples were taken before the dialysis from the dialysis catheter. Intravenous iron was administered during dialysis, at least 30 min after the start and at least 1 h before the end of dialysis.|Baseline to 6 weeks|The FAS population included all subjects who were randomised into the study, received at least one dose of the study drug, and had a Hb assessment. Subjects were included as randomised, regardless of which treatment they actually received.||percentage of participants|||Number
829031|NCT01223001|Secondary|Hopkins Verbal Learning Test|To compare the effect of duloxetine vs. placebo on the recovery of memory functions of patients with traumatic brain injury, utilizing the 20-minute delayed recall score of the Hopkins Verbal Learning Test (Brandt, 1991) as the secondary efficacy measure.|9 months||||||
829032|NCT01223001|Primary|Hamilton Rating Scale for Depression|To compare the efficacy of duloxetine 30 mg. PO daily to 120mg. PO daily with placebo in the prevention of depression associated with mild/moderate traumatic brain injury, utilizing the Hamilton Rating Scale for Depression (Hamilton, 1960; HAM-D) as the primary efficacy measure.|9 months|Analysis was not conducted. Study was terminated before interim analysis. Raw data is stored in a secure location, but not able to be accessed.|||||
829033|NCT01223027|Secondary|Pre-dose Concentration in Plasma in Dovitinib|Predose concentrations of dovitinib were summarized by visit using PAS. All concentration data was listed by patient and time point using FAS. Mean pre-dose concentrations along with standard deviation (SD) was plotted over time if appropriate.|Week 2 Day 5, Week 4 Day 5, Week 6 Day 5|Pharmacokinetic Analysis Set (PAS) consisted of all patients who received at least one dose of dovitinib and had at least one evaluable post-Baseline dovitinib concentration measurement.||ng/ml||Standard Deviation|Mean
829034|NCT01223027|Secondary|Patient-reported Outcomes (PROs): Time to Definitive Deterioration of the Quality of Life (QoL) Scale Scores of EORTC QLQ-C30 by at Least 10%|The EORTC QLQ-C30 contains 30 items and is composed of both multi-item scales and single-item measures. These include five functional scales (physical, role, emotional, social and cognitive functioning), three symptom scales (fatigue, pain, nausea, and vomiting), a global health status/QoL scale, and six single items (dyspnea, diarrhea, constipation, anorexia, insomnia and financial impact). Each of the multiitem scales includes a different set of items - no item occurs in more than one scale. Each item in the EORTC QLQ-C30 has 4 response categories (1=Not at all, 2= A little, 3= Quite a bit, 4= Very much) with the higher number representing a worse outcome.|from date of randomization|Full Analysis Set (FAS) consisted of all randomized patients.||Months||95% Confidence Interval|Median
829035|NCT01223027|Secondary|Patient-reported Outcomes (PROs): Time to Definitive Deterioration of the Physical Functioning (PF) Scale of EORTC QLQ-C30 by at Least 10%|The EORTC QLQ-C30 contains 30 items and is composed of both multi-item scales and single-item measures. These include five functional scales (physical, role, emotional, social and cognitive functioning), three symptom scales (fatigue, pain, nausea, and vomiting), a global health status/QoL scale, and six single items (dyspnea, diarrhea, constipation, anorexia, insomnia and financial impact). Each of the multiitem scales includes a different set of items - no item occurs in more than one scale. Each item in the EORTC QLQ-C30 has 4 response categories (1=Not at all, 2= A little, 3= Quite a bit, 4= Very much) with the higher number representing a worse outcome.|from date of randomization|Full Analysis Set (FAS) consisted of all randomized patients.||Months||95% Confidence Interval|Median
829036|NCT01223027|Secondary|Patient-reported Outcomes (PROs): Time to Deterioration of Functional Assessment of Cancer Therapy-Kidney Symptom Index, Disease Related Symptoms (FKSI-DRS) by at Least 2 Scores|The Kidney Cancer Symptom Index – Disease Related Symptoms (FKSI-DRS) is a validated symptom scale used in studies of patients with kidney cancer. It includes 9-items that assess pain, bone pain, fatigue, lack of energy, shortness of breath, fevers, weight loss, coughing, and blood in urine and responses to each question are answered on a 5-point Likert-type scale ranging from 0 to 4 (e.g., 0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; 4 = very much). FKSI-DRS scores range from 0 to 36, where higher scores correspond to better outcomes (eg, fewer symptoms).|from date of randomization, at least 2 score units|Full Analysis Set (FAS) consisted of all randomized patients.||Months||95% Confidence Interval|Median
829100|NCT01216397|Secondary|Linagliptin: Apparent Clearance of the Analyte in Plasma After Extravascular Administration (CL/F)|Geometric mean of the CL/F of linagliptin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set||mL/min||Geometric Coefficient of Variation|Geometric Mean
829101|NCT01216397|Secondary|Linagliptin: MRTpo (Mean Residence Time of the Analyte in the Body After Peroral Administration)|Geometric mean of the MRTpo of linagliptin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set||hr||Geometric Coefficient of Variation|Geometric Mean
829037|NCT01223027|Secondary|Time to Definitive Worsening of Karnofsky Performance Status (KPS)|Time to definitive worsening of Karnofsky performance status (KPS) was defined as the time from date of randomization to the date of definitive worsening of KPS or to the date of death whichever occurred earlier. Definitive worsening was defined as a definitive decrease in performance status by at least one Karnofsky category (i.e. at least 10 points less) compared to Baseline. Worsening was considered definitive if no later increase above the defined threshold was observed within the course of the study. A single measure reporting a decrease in Karnofsky performance status was sufficient to consider it as definitive only if it was the last one available for this patient. Time to definitive worsening of KPS was analyzed at the time of the final analysis for PFS.|from date of randomization to the date of definitive worsening of KPS or to the date of death whichever occurred earlier|Full Analysis Set (FAS) consited of all randomized patients.||Months||95% Confidence Interval|Median
829038|NCT01223027|Secondary|Percentage of Participants With Overall Response Rate (ORR) by Central Radiology Review|Overall response rate (ORR) was defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR). Best overall esponse (BOR) for each patient was determined from the sequence of overall (lesion) responses according to the following rules: CR = at least two determinations of CR at least 4 weeks apart before progression where confirmation required or one determination of CR prior to progression where confirmation not required. CR = at least two determinations of CR at least 4 weeks apart before progression where confirmation required or one determination of CR prior to progression where confirmation not required. SD = at least one SD assessment (or better) > 6 weeks after randomization (and not qualifying for CR or PR). PD = progression ≤ 17 weeks after randomization (and not qualifying for CR, PR or SD).|Until disease progression or discontinuation of treatment due to unacceptable toxicity|Full Analysis Set (FAS) consisted of all randomized patients.||Percentage of Participants|||Number
829039|NCT01223027|Secondary|Progression Free Survival (PFS) Per Investigator's Radiology Review|PFS was defined as the time from the date of randomization to the date of the first documented disease progression or death due to any cause. The primary analysis for PFS (based on central review) was also to be repeated on FAS considering the Investigator assessments and using the same analytical conventions as the primary analysis.|Until disease progression or discontinuation of treatment due to unacceptable toxicity|Full Analysis Set (FAS) consisted of all randomized patients.||Months||95% Confidence Interval|Median
829040|NCT01223027|Secondary|Overall Survival (OS)|Overall survival (OS) was the key secondary endpoint and was defined as the time from date of randomization to the date of death due to any cause. If a patient was not known to have died, survival was censored on the date of last contact.|until at least 386 deaths are documented in the clinical database.|Full Analysis Set (FAS) consisted of all randomized patients.||Months||95% Confidence Interval|Median
829041|NCT01223027|Primary|Progression Free Survival (PFS) Per Independent Central Radiology Review|Assessed according to RECIST 1.1. PFS was defined as the time from the date of randomization to the date of the first documented disease progression or death due to any cause. If a patient had not progressed or died, on the date of the analysis cut-off or when he/she received any further anti-neoplastic therapy, PFS was censored on the date of last tumor assessment before the cutoff date or the anti-neoplastic therapy date. The distribution of PFS was estimated using the Kaplan-Meier method. The median PFS along with 95% confidence intervals was presented by treatment group.|Until disease progression or discontinuation of treatment due to unacceptable toxicity up to 30-Jun-2014 (discontinuation)|Full Analysis Set (FAS) consisted of all randomized patients.||Months||95% Confidence Interval|Median
829042|NCT01223196|Other Pre-specified|Percentage (%) of Haemoglobin A1C|HbA1c (Haemoglobin A1c) is glycosylated haemoglobin, measured as a % of total Hb in red blood cells by a standard biochemical method (HPLC).|6 months|||Percentage (%) of HbA1c||Standard Error|Mean
829043|NCT01223196|Secondary|Effect of Pioglitazone on TNF (Tumor Necrosis Factor) Alpha Converting Enzyme (TACE) Activity in Skeletal Muscle.|The activity of TACE is measured by detecting the release of a fluorogenic synthetic substrate of TACE and measuring in a fluorometer. It is expressed in Fluorescence Units (F.U.)|6 months|These individuals completed both the baseline and all intermediate and the end of study visits.||Tace Activity in F.U./mg prot||Standard Error|Mean
829044|NCT01223196|Primary|Whole Body Insulin Sensitivity During the Euglycemic Insulin Clamp|"Insulin sensitivity was measured by the euglycemic clamp before and 6 months after PIO (PIOGLITAZONE) or PLAC (PLACEBO) treatment.
The outcome measure is Insulin sensitivity obtained from euglycemic insulin clamp and it is called M/I, where M = whole body glucose uptake during the euglycemic insulin clamp and I = circulating insulin levels during the euglycemic insulin clamp. It is expressed as Mg. of glucose/kg body weight/mU (milli Unit)x l (liter).of insulin (Ins)"|6 months|M/I||Mg. of glucose/kg body w./mUxl ins.||Standard Error|Mean
829102|NCT01216397|Secondary|t1/2 (Terminal Half-life of the Analyte in Plasma)|Geometric mean of the t1/2 of linagliptin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set||hr||Geometric Coefficient of Variation|Geometric Mean
829053|NCT01223365|Secondary|Current Opioid Misuse Measure (COMM) Scores During Both the Open-Label Titration and Open-Label Treatment Periods by Participant Status|The COMM was a clinician-rated scale developed as a brief self-report measure of current aberrant drug-related behavior for patients with chronic pain who were already on long-term opioid therapy. A total score was calculated as the sum of the 17 questions. The total score ranged from 0 to 68. A score of 0 indicates no aberrant drug-related behaviors were seen. Patients with a total score of 9 or greater were classified as exhibiting aberrant drug-related behavior.|Baseline for new participants was Day 1 of open-label titration; rollover participants baseline was in study 3079. End of Open-label Titration Period. Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 40, 44, 48, 52 and last visit up to week 52|Post titration Safety Analysis set||units on a scale||Standard Deviation|Mean
829054|NCT01223365|Secondary|Addiction Behavior Checklist (ABC) Total Scores During Both the Open-Label Titration and Open-Label Treatment Periods by Participant Status|The ABC was a clinician rated scale that consisted of a brief (21 item) questionnaire designed to track behaviors characteristic of addiction related to prescription opioid medications in chronic pain populations. Items were focused on observable behaviors noted both during and between clinic visits. Each affirmative response was counted as 1 point, and points were added to calculate the total score. All but 1 of the 21 items (the provider’s impression) was used in calculating the total score, consequently resulting in scores ranging from 0 to 20 (0=no addiction-related behaviors seen and higher scores indicating an increasing number of addition-related behaviors seen). Participants with a total score of 3 or greater were classified as exhibiting inappropriate opioid use during the study.|Baseline for new participants was Day 1 of open-label titration; rollover participants baseline was in study 3079. End of Open-label Titration: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 40, 44, 48, 52 and last visit up to week 52|Post-titration Safety Analysis set||units on a scale||Standard Deviation|Mean
829103|NCT01216397|Secondary|Linagliptin: λz (Terminal Elimination Rate Constant in Plasma)|Geometric mean of the λ_z of linagliptin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set||1/hr||Geometric Coefficient of Variation|Geometric Mean
829055|NCT01223365|Secondary|Participants by Risk Category for Aberrant Drug Misuse Based on the Total Score in the Screener and Opioid Assessment for Patients With Pain – Revised (SOAPP-R)|"SOAPP-R is a clinician-rated scale used to assess each patient’s risk of developing aberrant drug use behaviors while on long term opioid therapy. SOAPP-R consists of 24 questions that address 8 concepts: substance abuse history, medication related behaviors, antisocial behaviors/history, psychosocial problems, psychiatric history, physician patient relationship factors, emotional attachment to pain medications, and personal care and lifestyle issues (Butler et al 2008). Each question is answered using a 5 point Likert-like scale, with 0=never, 1=seldom, 2=sometimes, 3=often, and 4=very often for a total range of 0-96. The higher the overall score, the greater the probability the patient is at risk for displaying aberrant behaviors consistent with drug use.
An overall score of 18 or higher is considered positive for predicting aberrant drug related behavior, therefore the reported risk categories are
<18 and
<=18. Results indicate timeframe followed by risk cat"|End of Open-label Titration Period. Weeks 4 and 24 of the Open-label Treatment Period|Safety analysis set||Participants|||Count of Participants
829056|NCT01223365|Secondary|Participant Global Assessment (PGA) of the Method of Pain Control by Participant Status|The PGA of the method of pain control consisted of a asking patients a single question to assess their method of pain control during the previous 24 hours as either poor, fair, good, or excellent (Rothman et al 2009).|Baseline for new participants was Day 1, i.e. the first day of open-label titration. Baseline for rollover participants was the baseline in study 3079. Week 4 (end of titration, start of open-label treatment), Week 52, last visit up to Week 52|Full analysis set included all patients in the safety analysis set who had at least 1 postbaseline efficacy assessment. Participants contributing to each time point are listed in the time point label.||Participants|||Count of Participants
829057|NCT01223365|Primary|Participants With Clinically Significant (CS) Hearing Changes From Baseline in Pure Tone Audiometry Test Results by Patient Status|Pure tone audiometry was performed by trained personnel. During the test, the patient wore headphones and was seated in a quiet room; trained personnel manipulated the audiometry equipment to test the patient’s hearing. For serial audiograms, the criteria for a clinically significant (CS) hearing change were based on the guidance from the American Speech-Language Hearing Association (ASHA) 1994 (Konrad-Martin et al 2005). These criteria included the following: greater than 20 decibels (dB) pure tone threshold shift at 1 frequency; greater than 10 dB shift at 2 consecutive test frequencies; or threshold response shifting to “no response” at 3 consecutive test frequencies.|Baseline for new participants was between Day -7 and -14 (study 3080 screening visit); baseline for rollover participants was the baseline test in study 3079. During study covers both open-label titration and 52-week treatment periods|Safety analysis set. The endpoint value is from the post-titration safety set (n=42, 92, 157, 291)||Participants|||Count of Participants
829058|NCT01223365|Primary|Shifts in Electrocardiogram (ECG) Findings From Baseline to Overall Study by Participant Status|"A 12-lead ECG was conducted at screening, week 24, and week 52 or at the last postbaseline observation. For rollover participants, the ECG performed at the final visit of study 3079 served as the 1st ECG in study 3080. A qualified physician was responsible for interpreting the ECG. Any ECG finding that was judged by the investigator as a clinically meaningful change (worsening) compared with baseline was considered an adverse event.
For overall results, the worst postbaseline finding for the participant was summarized.
Results below are formatted as Baseline ECG result - Overall ECG result."|Baseline for new participants was between Day -7 and -14 (the study 3080 screening visit); baseline for rollover participants was the last ECG in study 3079. During study ECGs were performed on weeks 24 and 52 of the open-label treatment period|Post-titration Safety analysis set. Only those participants with both baseline and visit electrocardiogram findings were summarized.||Participants|||Count of Participants
829059|NCT01223365|Primary|Participants With Potentially Clinically Significant Abnormal Vital Signs Values by Participant Status|"Data represents participants with potentially clinically significant (PCS) vital sign values.
Significance criteria
Pulse - high: >=120 and increase of >= 15 beats/minute from baseline
Pulse - low: <=50 and decrease of >=15 beats/minute
Systolic blood pressure - high: >=180 and increase >=20 mmHg
Systolic blood pressure - low: <=90 and decrease >=20 mmHg
Diastolic blood pressure - high: >=105 and increase of >=15 mmHg
Diastolic blood pressure - low: <=50 and decrease of >=15 mmHg"|Day 1 of open-label titration period - Week 52 of the open-label treatment period|Safety analysis set. One rollover participant did not have vital signs values.||Participants|||Count of Participants
829060|NCT01223365|Primary|Participants With Potentially Clinically Significant (PCS) Abnormal Laboratory Values During the Open-Label Treatment Period by Participant Status|"Data represents participants with PCS abnormal serum chemistry, hematology and urinalysis values.
Significance criteria:
alanine aminotransferase (ALT): >=3 times the upper limit of normal (ULN). Normal range is 6-43 U/L
aspartate aminotransferase (AST): >=3 times ULN. Normal range is 9-36 U/L
blood urea nitrogen (BUN): >=10.71 mmol/L
creatinine: >=177 μmol/L
uric acid: M>=625, F>=506 μmol/L
white blood cell count: <=3.0*10^9/L
hemoglobin: M<=115, F<=95 g/dL
hematocrit: M<0.37, F<0.32 L/L
urine blood (hemoglobin): >=2 unit increase from baseline
urine glucose: >=2 unit increase from baseline"|Day 1 - Week 52 of the open-label treatment period|Posttitration Safety Analysis set. The posttitration safety analysis set included all patients who successfully completed the open label titration period and received 1 or more doses of study drug treatment in the open label treatment period.||Participants|||Count of Participants
829061|NCT01223365|Primary|Participants With Adverse Experiences|An adverse event (AE) was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 of open-label titration period - Week 52 of the open-label treatment period|Safety analysis set||Participants|||Count of Participants
829062|NCT01223469|Primary|Number of Subjects With Operative and Post-operative Serious Adverse Events|"For Right SVT patients 7 days (±1 day) following the index procedure or until hospital discharge whichever is longer.
For AF patients 3 months (±2 weeks)following the index procedure."|3 months for AF arm; 7 days for the right SVT arm|||participants|||Number
829063|NCT01223703|Secondary|Change in Mean New York Heart Association (NYHA) Functional Class Between Baseline and 12th Month Follow up.|"NYHA class I: No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs, etc...
NYHA class II: Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity.
NYHA class III: Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20–100 m). Comfortable only at rest NYHA class IV: Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients."|one year|||units on a scale||Standard Deviation|Mean
829064|NCT01223703|Secondary|Functional Capacity (Change in Peak Oxygen Uptake, VO2)|Change in functional capacity expressed as a peak oxygen uptake (VO2), that was acquired breath-by-breath by pneumotachograph (with bidirectional differential pressure) during cardiopulmonary exercize testing.|one year|||ml/kg/min||Standard Deviation|Mean
829065|NCT01223703|Secondary|LV Diastolic Function|Change in LV diastolic function assessed by echocardiography: mitral diastolic inflow velocities (peak velocity of early ventricular filling [E-wave], peak velocity of late ventricular filling [A-wave], E/A ratio, and E-wave deceleration time), diastolic function score (graded on a scale from 1 to 4) were used.|one year|||E/A ratio||Standard Deviation|Mean
829066|NCT01223703|Primary|Change in Left Ventricular (LV) Systolic Function Expressed as Left Ventricular Ejection Fraction (LVEF) Between Baseline and 12-month Follow-up|The primary end point of the study was the change in LV systolic function expressed as LVEF between baseline and 12-month follow-up. The following parameters were measured according to the professional standards defined by the American Society of Echocardiography and the European Association of Echocardiography|one year|A sample of 65 patients in each group was calculated to have 80% power to detect such 0.5 effect size with p<0.05 (2-tailed) at the Student t test for unpaired data.||ejection fraction (percentage)||Standard Deviation|Mean
829067|NCT01216163|Secondary|Participant Global Evaluation of Study Medication|Participant global evaluation of study medication was performed at the 6-hour time point or immediately before taking the rescue medication. It was scored on a 6-point categorical scale where 0 = Very poor, 1 = Poor, 2 = Fair, 3 = Good, 4 = Very Good, and 5 = Excellent.|6 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||units on a scale||Standard Deviation|Mean
829068|NCT01216163|Secondary|Cumulative Percentage of Participants With Complete Relief|Complete relief was defined as a PRR of 4. PRR was assessed on a 5-point categorical pain relief rating scale where 0=No relief to 4=Complete relief.|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||percentage of participants|||Number
829069|NCT01216163|Secondary|Cumulative Percentage of Participants With Treatment Failure|Percentage of participants who withdrew from the study due to lack of efficacy or received rescue medication.|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||percentage of participants|||Number
829070|NCT01216163|Secondary|Time to Treatment Failure|Median time of dropping out of the participants from the study due to lack of efficacy or use of rescue medication, whichever comes first.|0 to 6 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||hours||95% Confidence Interval|Median
829071|NCT01216163|Secondary|Cumulative Percentage of Participants With Confirmed First Perceptible Relief|Percentage of participants with first perceptible relief evaluated by stopping the stopwatch labeled 'first perceptible relief' at the moment participant first began to experience any relief. First perceptible relief was considered confirmed if the participant also stopped the second stopwatch indicating meaningful relief. Stopwatch was active up to 6 hours after dosing or until stopped by the participant, or rescue medication was administered.|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||percentage of participants|||Number
829072|NCT01216163|Secondary|Cumulative Percentage of Participants With Meaningful Relief|Percentage of participants with meaningful relief evaluated by stopping the stopwatch labeled ‘meaningful relief' at the moment participant first began to experience meaningful relief. Stopwatch was active up to 6 hours after dosing or until stopped by the participant, or rescue medication was administered.|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||percentage of participants|||Number
829073|NCT01216163|Secondary|Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID)|SPRID: time-weighted sum of PRID over 2 and 3 hours. Total score range: -2 (worst) to 14 (best) for SPRID 0-2, and -3 (worst) to 21 (best) for SPRID 0-3. PRID: sum of PID and PRR at each time point. Total score range for PRID: -1=worst to 7=best. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). Total score range for PID: -1 (worst) to 3 (best). PRR: assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief).|0 to 2, 0 to 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||units on a scale||Standard Deviation|Mean
829074|NCT01216163|Secondary|Time-weighted Sum of Pain Relief Rating (TOTPAR)|TOTPAR: time-weighted sum of PRR over 2, 3, and 6 hours. Total score range: 0 (worst) to 8 (best) for TOTPAR 0-2, 0 (worst) to 12 (best) for TOTPAR 0-3, and 0 (worst) to 24 (best) for TOTPAR 0-6. PRR was evaluated at different time points during the study up to 6 hours, and immediately after taking rescue medication (if necessary). PRR was assessed on a 5-point categorical pain relief rating scale where 0=No relief to 4=Complete relief.|0 to 2, 0 to 3, 0 to 6 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||units on a scale||Standard Deviation|Mean
829075|NCT01216163|Secondary|Time-weighted Sum of Pain Intensity Difference (SPID)|SPID: time-weighted sum of PID over 2, 3 and 6 hours. Total score range: -2 (worst) to 6 (best) for SPID 0-2, -3 (worst) to 9 (best) for SPID 0-3, and -6 (worst) to 18 (best) for SPID 0-6. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). Total score range for PID: -1 (worst) to 3 (best).|0 to 2, 0 to 3, 0 to 6 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||units on a scale||Standard Deviation|Mean
829076|NCT01216163|Secondary|Sum of Pain Relief Rating and Pain Intensity Difference (PRID)|PRID was sum of PID and PRR at each post-dosing time point. The overall possible score range, for PRID was -1 (worst) to 7 (best). PID was derived by subtracting the pain severity score at a given post-dosing time point (pain severity score range 0 [none] to 3 [severe]) from the baseline score (Baseline pain severity score range 2 [moderate] to 3 [severe]). Total possible score range for PID: -1 (worst) to 3 (best). PRR was assessed on 5-point categorical pain relief rating scale (0=No relief to 4=Complete relief).|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||units on a scale||Standard Deviation|Mean
829077|NCT01216163|Secondary|Pain Intensity Difference (PID)|PID was derived by subtracting the pain severity score at a given post-dosing time point (pain severity score range 0 [none] to 3 [severe]) from the baseline score (Baseline pain severity score range 2 [moderate] to 3 [severe]). Total possible score range for PID: -1 (worst) to 3 (best).|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||units on a scale||Standard Deviation|Mean
829078|NCT01216163|Secondary|Pain Relief Rating (PRR)|PRR was evaluated at different time points during the study up to 6 hours after taking the study medication, and immediately before rescue medication was taken (if necessary). PRR was assessed on a 5-point categorical pain relief rating scale where 0=No relief to 4=Complete relief.|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||units on a scale||Standard Deviation|Mean
829079|NCT01216163|Secondary|Time to Confirmed First Perceptible Relief|Participants evaluated the time to first perceptible relief by stopping a stopwatch labeled 'first perceptible relief' at the moment they first began to experience any relief. Stopwatch was active up to 6 hours after dosing or until stopped by the participant, or rescue medication was administered. The first perceptible relief was considered confirmed if the participant also stopped the second stopwatch indicating meaningful relief.|0 to 6 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||minutes||95% Confidence Interval|Median
829080|NCT01216163|Primary|Time to Onset of Meaningful Relief|Participants evaluated the time to meaningful relief by stopping a second stopwatch labeled ‘meaningful relief' at the moment they first began to experience meaningful relief. Stopwatch was active up to 6 hours after dosing or until stopped by the participant, or rescue medication was administered.|0 to 6 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||minutes||95% Confidence Interval|Median
829081|NCT01216163|Primary|Time-weighted Sum of Pain Relief Rating With Pain Intensity Difference From 0 to 6 Hours (SPRID 0-6)|SPRID: time-weighted sum of pain relief rating combined with pain intensity difference (PRID) over 6 hours. Score range: -6(worst) to 42(best) for SPRID 0-6. PRID: sum of pain intensity difference (PID) and pain relief rating (PRR) at each time point. Score range for PRID: -1(worst) to 7(best). PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). Total score range for PID: -1 (worst) to 3 (best). PRR: assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief).|0 to 6 hours|Intent-to-treat (ITT) population included all randomized participants who received study medication and provided a baseline assessment.||units on a scale||Standard Deviation|Mean
829082|NCT01216241|Primary|Percentage of Afebrile Neutropenic Subjects|To determine whether the percentage of neutropenic subjects that become afebrile by five days after fever first develops.|5 days|||participants|||Number
829083|NCT01216319|Secondary|Rate of Patient Satisfaction|Patient satisfaction is defined as patient would recommend the nipple reconstruction operation to others.|12 months|||percentage of patients|||Number
829084|NCT01216319|Primary|Percent Nipple Projection at 12 Months Compared to Baseline (1 Week Post-procedure)||12 months|There were two patients (three nipples) without plastic surgery matrix in place at 12MO.||percentage of projection vs baseline|Participants|Standard Deviation|Mean
829085|NCT01216397|Secondary|Assessment of Tolerability by the Investigator|Qualitative variable assessing the tolerability by the investigator|Day 1 to 4 for period 1, and day 36 to 39 for period 2|Treated Set||Participants|||Number
829086|NCT01216397|Secondary|Participants Who Discontinued the Trial Because of an Adverse Event|Number of participants who discontinued the trial because of an adverse event|Day 1 to 4 for period 1, and day 36 to 39 for period 2|Treated Set||Participants|||Number
829087|NCT01216397|Secondary|Participants With Treatment Emergent Adverse Events|Number of patients with treatment emergent AEs|Day 1 to 4 for period 1, and day 36 to 39 for period 2|Treated Set||Participants|||Number
829088|NCT01216397|Secondary|Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities|12-lead-Electrocardiogram (ECG), vital sign (blood pressure and pulse rate), physical finding and laboratory abnormalities|Day 1 to 4 for period 1, and day 36 to 39 for period 2|Treated Set||Participants|||Number
829089|NCT01216397|Secondary|Metformin: Vz/F|Geometric mean of Vz/F of metformin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set||Liter||Geometric Coefficient of Variation|Geometric Mean
829090|NCT01216397|Secondary|Metformin: CL/F|Geometric mean of CL/F of metformin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set||mL/min||Geometric Coefficient of Variation|Geometric Mean
829091|NCT01216397|Secondary|Metformin: MRTpo (Mean Residence Time of the Analyte in the Body After Peroral Administration)|Geometric mean of MRTpo of metformin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set||hr||Geometric Coefficient of Variation|Geometric Mean
829092|NCT01216397|Secondary|Metformin: t1/2 (Terminal Half-life of the Analyte in Plasma)|Geometric mean of t1/2 of metformin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set||hr||Geometric Coefficient of Variation|Geometric Mean
829093|NCT01216397|Secondary|Metformin: λz (Terminal Elimination Rate Constant in Plasma)|Geometric mean of λz of metformin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set||1/hr||Geometric Coefficient of Variation|Geometric Mean
829094|NCT01216397|Secondary|Metformin: Tmax|Median of tmax of metformin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set||hr||Full Range|Median
829095|NCT01216397|Secondary|Metformin: Percentage of AUCtz-∞ Obtained by Extrapolation|Geometric Mean of the percentage of AUCtz-infinity of Metformin, where percentage is the unit of measurement.|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set||percentage||Geometric Coefficient of Variation|Geometric Mean
829134|NCT01216631|Primary|Ultrasound Synovitis Score|reduction of ultrasound synovitis score of the affected knee at 8 weeks following intiation of treatment|8 weeks|Only one patient was recruited for this study due to problems with recruitment. Therefore outcome measure data is not analysed as only one patient was recruited.|||||
829135|NCT01216735|Secondary|Flow-mediated Brachial Vasodilation (FMD% Peak Delta)|Flow-mediated vasodilation response in the brachial artery will be measured before and 15 minutes.after albuterol inhalation|3 weeks of treatment|||% change||Standard Error|Mean
829136|NCT01216735|Primary|Albuterol Induced Change in Qaw Before and After Fluticasone or Placebo|Airway Blood flow (Qaw) will be measured before and 15 minutes after albuterol inhalation (delta Qaw).|3 weeks treatment period of ICS or placebo|||% change||Standard Error|Mean
829137|NCT01216748|Secondary|Exhaled Breath Condensate (EBC) pH Variation|"EBC samples were collected at each respiratory maneuver by directing the subject's exhaled breath into a pre-cooled (-10C) tube for 10 min.
pH was measured immediately after collection."|10 minutes after each respiratory manouver.|||pH||Standard Error|Mean
829138|NCT01216748|Primary|Changes in Airway Blood Flow After 180μg Albuterol by Inhalation (ΔQaw) vs Baseline|Effect of airway pH on albuterol responsiveness as reflected by the change in airway blood flow after 180μg albuterol by inhalation (ΔQaw) vs baseline.|15 minutes after albuterol inhalation|||changes from baseline in μl.min-1.ml-1||Standard Error|Mean
829139|NCT01216761|Primary|Blood Culture Contamination|A culture set was considered contaminated if it yielded growth of typical skin contaminants including aerobic gram positive rods, Lactobacillus sp, Propionibacterium acnes, Micrococcus sp, Bacillus sp (not B. anthracis or B. cereus), coag negative Staphylococcus, Neisseria sp (not N. meningitides or N. gonorrhoeae), or gamma-hemolytic streptococci (not Enterococcus sp) from only 1 of 2 or more blood culture sets obtained from different sites.|5 days|Intention to treat analyses. Please note: it is possible for a single patient to have multiple blood culture sets obtained throughout the study. Therefore, number of blood culture sets will differ from the number of unique patients.||blood culture sets|Blood culture sets||Number
829140|NCT01223937|Secondary|Minimum Post-Treatment Serum Sodium Levels|Serum sodium levels were monitored since hyponatremia is a potential serious adverse event associated with daily doses of desmopressin. The serum sodium level must have been within the normal reference range at the Screening Visit for the participant to be eligible for enrollment. A participant was to be withdrawn from the trial if the serum sodium level was <=125 mmol/L at any time.|Day 1 up to 3 months|Safety analysis set||participants|||Number
829141|NCT01223937|Secondary|Summary of Participants With Treatment-Emergent Adverse Events (TEAEs)|A TEAE was any adverse event occurring after start of treatment and within the time of residual drug effect, i.e., within 1 day of the last dose of desmopressin. An adverse drug reaction (ADR) was any AE assessed by the Investigator as possibly/probably related to study drug.|Day 1 up to 3 months|Safety analysis set||participants|||Number
829142|NCT01223937|Secondary|Change From Baseline in 24-Hour Urine Volume at Month 3|"Twenty-four hour urine volume was derived from the 3-day urine volume diary. Mean urine volumes were calculated as the average over 3 consecutive 24-hour periods prior to the Month 3 visit.
The secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed."|Day 1 (Baseline), Month 3|Full Analysis Set (FAS), including participants with complete data supporting this outcome in the participant diary.||mL||Standard Deviation|Mean
829143|NCT01223937|Secondary|Change From Baseline in Nocturnal Urine Volume at Month 3|"The nocturnal urine volume was derived from the 3-day urine volume diary. The nocturnal urine volume included the volume of the first morning void. Mean urine volumes were calculated as the average over 3 consecutive 24-hour periods prior to the Month 3 visit.
The secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed."|Day 1 (Baseline), Month 3|Full Analysis Set (FAS), including participants with complete data supporting this outcome in the participant diary.||mL||Standard Deviation|Mean
829144|NCT01223937|Secondary|Change From Baseline in Mean Time to First Nocturnal Void at Month 3|"The time to first void was defined as the time from going to bed with the intention of sleeping until first nocturnal void or until waking in the morning in cases where there was no nocturnal void. The time to first void was derived from the sleep and voiding diary. The mean time to first void was calculated as the average over 3 consecutive 24-hour periods prior to the Month 3 visit.
The secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed."|Day 1 (Baseline), Month 3|Full Analysis Set (FAS), including participants with complete data supporting this outcome in the participant diary.||minutes||Standard Deviation|Mean
829145|NCT01223937|Secondary|Adjusted Probability of Participants Achieving a >33% Reduction From Baseline in Number of Nocturnal Voids at Month 3|"Probability of participants achieving 33% responder status at Month 3 employed a longitudinal analysis assessing nocturnal void information captured in the 3-day diary. A 33% responder was defined as a participant with a decrease of at least 33% in the mean number of nocturnal voids relative to baseline. The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to Day 1 and prior to the Month 3 visit as recorded in participant diaries. The first morning void was not counted as a nocturnal void.
The secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed."|Day 1 (Baseline), Month 3|Full Analysis Set (FAS), including participants with complete data supporting this outcome in the participant diary.||probability|||Number
829146|NCT01223937|Secondary|Change From Baseline in Mean Number of Nocturnal Voids at Month 3|"The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to Day 1 and prior to the during-treatment visits (Month 3 for this outcome) as recorded in participant diaries. The first morning void was not counted as a nocturnal void.
Secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed."|Day 1 (Baseline), Month 3|Full Analysis Set (FAS), including participants with complete data supporting this outcome in the participant diary.||nocturnal voids||Standard Deviation|Mean
829166|NCT01224782|Secondary|Mean Weekly Dose of Zemplar (Paricalcitol)|Compliance was assessed using the mean weekly total dose of Zemplar (paricalcitol).|From Baseline up to 12 months|Secondary analyses were conducted in the intent-to-treat (ITT) population, which included all participants who received at least 1 dose of study drug and with available data.||micrograms||Standard Deviation|Mean
829234|NCT01225354|Primary|Self-esteem|Self-esteem change will be determined by patient self-evaluation using the Heatherton & Polivy State Self-Esteem (HPSS). The primary variable will be measured as improvement in self-esteem from baseline self-evaluations.|2 weeks post optimal cosmetic result|||Participants with improved self-esteem|||Number
829147|NCT01223937|Primary|Adjusted Probability of Participants Achieving a >33% Reduction From Baseline in Number of Nocturnal Voids for All During-Treatment Visits up to Month 3|"Probability of participants achieving 33% responder status during 3 months of treatment employed a longitudinal analysis assessing nocturnal void information captured in the 3-day diary. A 33% responder was defined as a participant with a decrease of at least 33% in the mean number of nocturnal voids relative to baseline. The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to Day 1 and prior to the during treatment visits (Week 1, Months 1, 2, 3) as recorded in participant diaries. The first morning void was not counted as a nocturnal void.
This was the second co-primary endpoint. The trial was to be declared positive only if the 25 μg desmopressin group had a statistically significant positive effect as compared to placebo on both co-primary endpoints."|Day 1 (Baseline); Week 1, Months 1, 2, 3 (3-month treatment period)|Full analysis set (FAS).||probability|||Number
829148|NCT01223937|Primary|Change From Baseline in Mean Number of Nocturnal Voids Averaged Over a 3-Month Period|"The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to Day 1 and prior to the during-treatment visits (Week 1, Months 1, 2, 3) as recorded in participant diaries. The first morning void was not counted as a nocturnal void. Change from baseline values for Week 1, and Months 1, 2 and 3 are reported below.
Comparison of the mean number of nocturnal voids at baseline and over a 3-month treatment period (obtained by longitudinal analysis of Week 1, and Months 1, 2 and 3) are reported in the statistical analysis. This was the first co-primary endpoint. The trial was to be declared positive only if the 25 μg desmopressin group had a statistically significant positive effect as compared to placebo on both co-primary endpoints."|Day 1 (Baseline); Week 1, Months 1, 2, 3 (3-month treatment period)|Full analysis set (FAS).||nocturnal voids||Standard Deviation|Mean
829149|NCT01224015|Primary|Percentage of Participants Achieving a Grade of None or Mild at Maximum Smile Based on the Investigator Facial Wrinkle Scale Assessment of the Severity of Crow's Feet Lines|The investigator assessed the severity of the patient's Crow’s Feet Lines at maximum smile using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30 is reported.|Day 30|Participants from the Intent-to-treat population, consisting of all randomized participants with data available for analysis.||Percentage of participants|||Number
829150|NCT01224626|Primary|Number of Participants Categorized as Responders (Cure and Improved) to Zyvox (Linezolid) Treatment.|Clinical overall effectiveness was evaluated by investigators based on clinical symptoms, laboratory test and investigator judgement, at the end of observation period. Clinical rating (cure/improved/not cured/unable to evaluate) was carried out. Definition of cured was disappearance of clinical symptom and/or Laboratory test abnormality. Definition of improved was improvement in clinical symptoms and/or laboratory test abnormality.|Baseline to 8 weeks|The efficacy analysis population included all subjects from the safety analysis population in whom the efficacy of this drug could be evaluated.||participants|||Number
829151|NCT01224626|Secondary|Adverse Drug Reactions Unlisted in Japanese Package Insert.|The adverse drug reactions that have not been included in Japanese package insert.|Baseline to 8 weeks|Safety analysis population consisted of the participants that satisfied the inclusion and exclusion conditions and in whom administration of this drug was confirmed.||participants|||Number
829152|NCT01224626|Primary|Number of Participants With Adverse Drug Reactions.|All observed or volunteered adverse events and the investigator’s opinion of the causal relationship to the study treatment were reported as adverse events. Definition of adverse drug reaction was treatment related adverse events which were evaluated in company with the causal relationship to the investigational product.|Baseline to 8 weeks|Safety analysis population consisted of the participants that satisfied the inclusion and exclusion conditions and in whom administration of this drug was confirmed.||participants|||Number
829153|NCT01224639|Secondary|Titers of Vaccine Viremia||14 Days after each vaccination|Due to the low prevalence of vaccine viremia, estimates of average titer levels of viral RNA within study groups would not be meaningful. Therefore as per change in planned analysis only number of participants with positive vaccine viremia of all four vaccine strain serotypes after first and second vaccination was reported.|||||
829154|NCT01224639|Secondary|Duration of Vaccine Viremia||14 Days after each vaccination|Due to the low prevalence of vaccine viremia, estimates of average titer duration of viral RNA within study groups would not be meaningful. Therefore as per change in planned analysis only number of participants with positive vaccine viremia of all four vaccine strain serotypes after first and second vaccination was reported.|||||
829155|NCT01224639|Secondary|Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination|Serotype-specific vaccine viremia was assessed for the four vaccine strain serotypes: TDV-1, TDV-2, TDV-3 and TDV-4. Only those serotypes and time-points where at least 1 participant had serotype-specific vaccine viremia detection were reported.|Baseline and at multiple time points up to Day 14 after each vaccination|The FAS included all randomized participants who received at least one dose of study vaccine and for whom valid pre- and post-dosing blood samples were received.||participants|||Number
829156|NCT01224639|Secondary|Percentage of Participants With Durability of Immune Response|Immune response was considered durable if the participant had detectable neutralizing antibodies (seroconversion) to all 4 dengue serotypes at 90 and 180 days after the second dose (i.e. Days 180 and 270, respectively). Seroconversion is defined as post-vaccination PRNT(50) titer >=10 where pre-vaccination PRNT 50 titer <10, or post-vaccination PRNT(50) Titer >=4-fold the pre-vaccination PRNT(50) titer value where pre-vaccination PRNT(50) titer >=10. Percentage of participants with seroconversion on Days 180 and 270 are based on the number of participants in the FAS with non-missing MN assay samples at each visit. The 95% CIs for percentages are the exact CIs (%) based upon the binomial distribution.|Days 180 and 270|The FAS included all randomized participants who received at least one dose of study vaccine and for whom valid pre- and post-dosing blood samples were received.||percentage of participants||95% Confidence Interval|Number
829167|NCT01224782|Secondary|Percentage of Participants With Hypercalcemia|The percentage of participants with hypercalcemia (Calcium > 2.6 mmol/L [10.5 mg/dL]) at any timepoint during followup, up to 12 months.|From Baseline up to 12 months|The safety population included all participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug.||percentage of participants|||Number
836878|NCT01301079|Primary|Pain 30 Minutes|The scale measure pain after 30 minutes (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10.|30 minutes|||units on a scale||Standard Deviation|Mean
829157|NCT01224639|Secondary|Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination|Seroconversion was defined as a PRNT titer resulting in 50% reduction in plaques (PRNT[50]) >=10 (if the pre-vaccination PRNT[50] value was <10, indicated as a value of 5 in the immunogenicity data collection sheet) OR a PRNT(50) value that was >=4-fold the pre-vaccination titer value (if the pre-vaccination PRNT[50] value was >=10). Seroconversion was assessed for the four dengue serotypes: TDV-1, TDV-2, TDV-3 and TDV-4. The 95% CIs for percentages are the exact CIs (%) based upon the binomial distribution. Percentages are based on the number of participants in the FAS with non-missing MN assay samples at each visit (n).|Days 14 and 30 after second vaccination (Days 104 and 120 respectively)|The FAS included all randomized participants who received at least one dose of study vaccine and for whom valid pre- and post-dosing blood samples were received.||percentage of participants||95% Confidence Interval|Number
829158|NCT01224639|Secondary|Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination|Seroconversion was defined as a Plaque Reduction Neutralization Test (PRNT) titer resulting in 50% reduction in plaques (PRNT[50]) >=10 (if the pre-vaccination PRNT[50] value was <10, indicated as a value of 5 in the immunogenicity data collection sheet) OR a PRNT(50) value that was >=4-fold the pre-vaccination titer value (if the pre-vaccination PRNT[50] value was >=10). Seroconversion was assessed for the four dengue serotypes: TDV-1, TDV-2, TDV-3 and TDV-4. The 95% CIs for percentages are the exact CIs (%) based upon the binomial distribution. Percentages are based on the number of participants in the FAS with non-missing MN assay samples at each visit.|Days 14, 30, 60 and 90 after first vaccination|The FAS included all randomized participants who received at least one dose of study vaccine and for whom valid pre- and post-dosing blood samples were received.||percentage of participants||95% Confidence Interval|Number
829159|NCT01224639|Secondary|GMTs of All Four Dengue Serotypes After Second Vaccination|GMT was assessed for the four dengue serotypes: TDV-1, TDV-2, TDV-3 and TDV-4. GMTs and 95% CIs were calculated by taking the anti-logs of the means and 95% CI of the log transformed titers.|Days 14 and 30 after second vaccination (Day 104 and 120 respectively)|The FAS included all randomized participants who received at least one dose of study vaccine and for whom valid pre- and post-dosing blood samples were received. Here 'n' is number of participants with non-missing MN Assay samples.||titer||95% Confidence Interval|Geometric Mean
829160|NCT01224639|Secondary|Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination|GMT was assessed for the four dengue serotypes: Dengue TDV-1, TDV-2, TDV-3 and TDV-4. GMTs and 95 percent (%) confidence interval (CIs) were calculated by taking the anti-logs of the means and 95% CI of the log transformed titers.|Days 14, 30, 60 and 90 after first vaccination|The full analysis set (FAS) included all randomized participants who received at least one dose of study vaccine and for whom valid pre- and post-dosing blood samples were received. Here 'n' is number of participants with non-missing microneutralization (MN) Assay samples.||titer||95% Confidence Interval|Geometric Mean
829161|NCT01224639|Primary|Number of Participants With Unsolicited Local and Systemic AEs||Baseline up to 30 days after second vaccination (Day 120)|The safety population included all randomized participants who received at least one dose of study vaccine and for whom post-dosing safety data was obtained.||participants|||Number
829162|NCT01224639|Primary|Number of Participants With Solicited Local and Systemic AEs||Within 14 days after either of the vaccination given on Day 1 or 90 (Day 14 for first vaccination, Day 104 for second vaccination)|The safety population included all randomized participants who received at least one dose of study vaccine and for whom post-dosing safety data was obtained.||participants|||Number
829163|NCT01224639|Primary|Number of Participants With Systemic Adverse Events (AEs) by Severity|Solicited systemic AEs were reported using a participant diary. Solicited systemic AEs included fever (>= 37.8°C), headache, muscle pain, joint pain, eye pain, photophobia, fatigue, body rash, nausea, vomiting and other (any other symptom not listed in the diary) and were categorized as Mild: transient symptoms, discomfort noticed but easily tolerated, no interference to normal daily activities; Moderate: marked symptoms, moderate interference with daily activities; Severe: considerable interference with daily activities.|Within 14 days after either of the vaccination given on Day 1 or 90 (Day 14 for first vaccination, Day 104 for second vaccination)|The safety population included all randomized participants who received at least one dose of study vaccine and for whom post-dosing safety data was obtained.||participants|||Number
829164|NCT01224639|Primary|Number of Participants With Local Injection Site Reaction by Severity|Solicited local reactions were reported using a participant diary. Pain was categorized as Mild (aware of pain but it does not interfere with daily activity and no pain medication is taken); Moderate (aware of pain; there is interference with daily activity or it requires use of pain medication); Severe (aware of pain and it prevents daily activity), redness was categorized as Mild (greater than [>] 15 millimeter [mm]); Moderate as (15-30 mm); Severe (>30 mm), swelling was categorized as Mild (<15 mm); Moderate (15-30 mm); Severe (>30 mm), and itching was categorized as Mild (slight itching at injection site); Moderate (moderate itching at injection extremity); Severe (itching over entire body).|Within 14 days after either of the vaccination given on Day 1 or 90 (Day 14 for first vaccination, Day 104 for second vaccination)|The safety population included all randomized participants who received at least one dose of study vaccine and for whom post-dosing safety data was obtained.||participants|||Number
829165|NCT01224782|Secondary|Number of Participants With Adverse Events (AEs)|An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. An Adverse Drug Reaction (ADR) is any noxious and undesired reaction related to an experimental drug or experiment. A serious adverse event (SAE) is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome. AEs were rated for severity as either Mild: transient and easily tolerated; Moderate: causes discomfort and interrupts usual activities; or Severe: causes considerable interference with usual activities, may be incapacitating or life-threatening. AEs related to Zemplar (paricalcitol) were assessed as being either probably or possibly related by the investigator.|Adverse events were collected from the screening visit to month 12 (total 13 months); Serious Adverse Events were collected from the time that informed consent was obtained to 30 days after last dose of study drug (up to 13 months)|The safety population included all participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug .||participants|||Number
829168|NCT01224782|Secondary|Percentage of Participants Who Achieved a > 30% Decrease From Baseline in Intact Parathyroid Hormone (iPTH)|The percentage of participants with a decrease in iPTH levels > 30% at any timepoint during followup, up to 12 months.|From Baseline up to 12 Months|Secondary analyses were conducted in the intent-to-treat (ITT) population, which included all participants who received at least 1 dose of study drug and with available data.||percentage of participants|||Number
829169|NCT01224782|Primary|Percentage of Participants With Calcium x Phosphorus Product (CxP) Values > 65 mg˄2/dL˄2 or 5.24 mmol˄2/L˄2|The percentage of participants with Calcium x Phosphorus Product (CxP) values > 65 mg˄2/dL˄2 or 5.24 mmol˄2/L˄2 at any timepoint during followup, up to 12 months.|From Baseline up to 12 Months|The primary analysis was conducted in the per-protocol (PP) population, which included all participants for whom all study criteria were fulfilled at the time of enrollment and who had no major protocol deviation occur in the course of the study.||percentage of participants|||Number
829170|NCT01224782|Primary|Time to Achieve a > 30% Decrease From Baseline in Intact Parathyroid Hormone (iPTH) Values|Mean time to achieve a > 30% decrease in intact parathyroid hormone (iPTH) compared with the initial values at baseline (screening visit).|From Baseline up to 12 Months|The primary analysis was conducted in the per-protocol (PP) population, which included all participants for whom all study criteria were fulfilled at the time of enrollment and who had no major protocol deviation occur in the course of the study, with a > 30% decrease in iPTH compared with the initial values at baseline.||months||Standard Deviation|Mean
829171|NCT01224821|Secondary|Time to Disease Progression or Death for All Participants, as Assessed by the Investigator|Progression-free survival or time to progression is defined as the time from the dosimetric dose to the first documented occurrence of disease progression or death.|Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months|ITT Exposed Population. Only participants with disease progression or those who died were analyzed.||months||95% Confidence Interval|Median
829172|NCT01224821|Secondary|Time to Disease Progression or Death for Responders, as Assessed by the Investigator|Progression-free survival or time to progression is defined as the time from the dosimetric dose to the first documented occurrence of disease progression or death.|Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months|ITT Exposed Population. Only participants classified as responders with disease progression or those who died were analyzed.||months||95% Confidence Interval|Median
829173|NCT01224821|Secondary|Overall Survival|Overall survival is defined as the time from the treatment start date to the date of death from any cause. Time to death is the time from the dosimetric dose to the date of death.|Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months|ITT Exposed Population. Only those participants who died during the study were analyzed.||months||95% Confidence Interval|Median
829174|NCT01224821|Secondary|Median Time to Treatment Failure for All Participants|Time to treatment failure is defined as the length of time from the date of enrollment to the first incidence of treatment withdrawal, study removal, progression, and/or alternative therapy for the participant's lymphoma, or death.|Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months|ITT Exposed Population||months||95% Confidence Interval|Median
829175|NCT01224821|Secondary|Duration of Response for All Unconfirmed Clinical Complete Responders, as Assessed by the Investigator|Duration of response is defined as the time from the first documented response until disease progression. Disease progression is defined as a >=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be >2 cm in diameter by radiographic evaluation or >1 cm in diameter by physical examination.|Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months|ITT Exposed Population. Only those participants with a confirmed CCR were analyzed.||months||95% Confidence Interval|Median
829176|NCT01224821|Secondary|Duration of Response for All Confirmed Clinical Complete Responders, as Assessed by the Investigator|Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Duration of response is defined as the time from the first documented response until disease progression. Disease progression is defined as a >=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be >2 cm in diameter by radiographic evaluation or >1 cm in diameter by physical examination.|Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months|ITT Exposed Population. Only those participants with a confirmed CCR were analyzed.||months||95% Confidence Interval|Median
829177|NCT01224821|Secondary|Duration of Response for All Unconfirmed Complete Responders, as Assessed by the Investigator|Duration of response is defined as the time from the first documented response until disease progression. Disease progression is defined as a >=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be >2 cm in diameter by radiographic evaluation or >1 cm in diameter by physical examination.|Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months|ITT Exposed Population. Only those participants with a confirmed CR were analyzed.||months||95% Confidence Interval|Median
829178|NCT01224821|Secondary|Duration of Response for All Confirmed Complete Responders, as Assessed by the Investigator|Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Duration of response is defined as the time from the first documented response until disease progression. Disease progression is defined as a >=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be >2 cm in diameter by radiographic evaluation or >1 cm in diameter by physical examination.|Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months|ITT Exposed Population. Only those participants with a confirmed CR were analyzed.||months||95% Confidence Interval|Median
829192|NCT01225055|Secondary|C-terminal Telopeptide|Change in C-terminal telopeptide from baseline after 12 month of treatment|12 months|||ng/ml||95% Confidence Interval|Mean
829179|NCT01224821|Secondary|Duration of Response for All Unconfirmed Responders (CR, CCR, or PR), as Assessed by the Investigator|Duration of response is defined as the time from the first documented response until disease progression. Disease progression is defined as a >=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be >2 cm in diameter by radiographic evaluation or >1 cm in diameter by physical examination.|Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months|ITT Exposed Population. Only those participants with a confirmed response were analyzed.||months||95% Confidence Interval|Median
829180|NCT01224821|Secondary|Duration of Response for All Confirmed Responders (CR, CCR, or PR), as Assessed by the Investigator|Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Duration of response is defined as the time from the first documented response until disease progression. Disease progression is defined as a >=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be >2 cm in diameter by radiographic evaluation or >1 cm in diameter by physical examination.|Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months|ITT Exposed Population. Only those participants with a confirmed response were analyzed.||months||95% Confidence Interval|Median
829181|NCT01224821|Secondary|Number of Participants With Confirmed CR and CCR, as Assessed by the Investigator|The total number of participants with CR and CCR was reported. Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. Clinical Complete Response: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present.|Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months|ITT Exposed Population. Only those participants evaluable for confirmed CR and CCR were analyzed.||participants|||Number
829182|NCT01224821|Secondary|Number of Participants With CR and CCR, as Assessed by the Investigator|The total number of participants with CR and CCR was reported. CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. Clinical Complete Response: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present.|Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months|ITT Exposed Population. Only those participants evaluable for response were analyzed.||participants|||Number
829183|NCT01224821|Secondary|Number of Participants With Confirmed Response (CR, CCR, or PR), as Assessed by the Investigator|Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Par. with confirmed response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).|Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months|ITT Exposed Population. Only those participants evaluable for confirmed response were analyzed.||participants|||Number
829184|NCT01224821|Secondary|Number of Participants (Par.) With Response (CR, CCR, or PR), as Assessed by the Investigator|Par. with response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).|Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months|ITT Exposed Population. Only those participants evaluable for response were analyzed.||participants|||Number
829185|NCT01224821|Secondary|Number of Participants With the Indicated Therapeutic Doses (TD) (Total Body Dose)|Based on their platelet count and body weight. Participants received different TDs of TST. For obese participants (weighing more than 137% of their calculated lean body weight), the calculation to determine the administered activity (mCi) was performed using the maximum effective mass (i.e., the minimum of the participant’s mass and 137% of their calculated lean body weight). The administered activity (mCi) for participants with a Baseline platelet count of 100001–149999 cells/millimeter cubed (mm^3) was reduced to a 65 cGy total body dose, after any adjustment for obesity.|Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months|ITT Exposed Population||participants|||Number
829186|NCT01224821|Primary|Number of Participants Who Received the Therapeutic Dose at the Seven Clinical Research Sites|The dosimetry methods were validated for seven different clinical research sites.|Day 1 within one hour of infusion (I) and prior to urination (U); Days 2, 3, and 4 after dosimetric dose (DD) I, following U; Days 6 and 7 after DD I, following U|Intent-to-Treat (ITT) Exposed Population: all participants who enrolled in the study and received at least one dose of study drug. One participant did not receive the therapeutic dose.||participants|||Number
829187|NCT01225029|Secondary|Time to First Enteral Feed||hour until first enteral feed achieved, an average of approximately 40 hours and a maximum of 100 hours|||hours||Inter-Quartile Range|Mean
829188|NCT01225029|Secondary|Duration of ICU Admission||every day until discharge, an average of approximately 8 days and a maximum of 12 days|||calendar days||Inter-Quartile Range|Mean
829189|NCT01225029|Primary|Duration of Respiratory Support||every hour until patient stable without respiratory support, an average of approximately 55 hours and a maximum of 205 hours|||hours||Inter-Quartile Range|Median
829190|NCT01225055|Secondary|Amino-terminal Propeptide of Type 1 Collagen|Change in Amino-terminal of type 1 collagen from baseline after 12 months of treatment|12 months|||ng/ml||95% Confidence Interval|Mean
829191|NCT01225055|Secondary|Bone-specific Alkaline Phosphatase|Change in Bone-specific alkaline phosphatase from baseline after 12 month of therapy|12 months|||ng/ml||95% Confidence Interval|Mean
829196|NCT01225068|Primary|Effect Size of VAS Pain|"Effect size (ES) calculation for VAS pain between milnacipran and placebo groups' ES is dimensionless; Visual analogue scale (VAS) measured pain in integral units from 0 (low end) to 100 (high end); ES (Cohen's d) is a well described statistical construct and is calculated from the difference between the means (determined at baseline and 6 weeks here) divided by the pooled standard deviation.
This is the primary outcome measure."|6 weeks from baseline|per protocol||units on a scale||Standard Deviation|Mean
829197|NCT01225146|Secondary|Goldman Visual Field Changes|Goldman Visual Field changes at 6 and 12 months from baseline|12 months|Data for this outcome measure were not collected. The study was terminated because the collaborator, Genentech, stopped production of the study drug (2.0 mg ranibizumab). Analysis of this outcome was therefore deferred and is being rolled over to the WAVE study program (NCT01710839, IND 12246)|||||
829198|NCT01225146|Secondary|Changes, by Disc Areas, of Capillary Non-perfusion in the Periphery|Changes, by disc areas, of capillary non-perfusion in the periphery (evaluated by wide-field fluorescein angiography) at 3, 6, 9 and 12 months from baseline.|12 months|Data for this outcome measure were not collected. The study was terminated because the collaborator, Genentech, stopped production of the study drug (2.0 mg ranibizumab). Analysis of this outcome was therefore deferred and is being rolled over to the WAVE study program (NCT01710839, IND 12246)|||||
829199|NCT01225146|Secondary|Mean Change in Central Foveal Volume|Mean change in Central Foveal Volume on High Resolution OCT|12 months|Patients in cohort 2 did not complete the study.||mm^3||Full Range|Mean
829200|NCT01225146|Secondary|Neovascularization Development|Percent of patients that develop neovascularization of the iris, optic nerve and/or elsewhere.|12 months|Patients in cohort 2 did not complete the study.||Percentage of patients|||Number
829201|NCT01225146|Secondary|Incidence and Severity of Adverse Events (Ocular and Non-ocular).|Incidence and severity of adverse events (ocular and non-ocular) from baseline through 12 months will be evaluated.|12 months|||incidents|||Number
829202|NCT01225146|Primary|Mean Change in logMAR|Mean change from baseline in ETDRS NCVA.|12 months.|Patients in cohort 2 did not complete the study.||logMAR||Full Range|Mean
829203|NCT01225159|Secondary|Morbidities and All Causes Mortality|morbidities defined as hypoglycaemia (blood sugar less than 60 mg/dL), Stroke (focal neurological deficit confirmed with CT or MRI), acute renal failure (rising of creatinine)|within the first 30 days after surgery|||participants|||Number
829204|NCT01225159|Primary|Nosocomial Infection|Infection rate referred to the rate of nosocomial infection, including pneumonia, central line infection, surgical wound infection, deep sternal wound infection, urinary tract infection, and sepsis. Infections were defined according to the Centers for Disease Control and Prevention (CDC) definitions, occurring within 30 days postoperative cardiac surgery.|within the first 30 day after surgery|||participants|||Number
829205|NCT01225211|Secondary|Cohort 4: Absolute Change From Baseline in Weight at Day 56||Cohort 4: Baseline, Day 56|Cohort 4 Full Analysis Set included all randomized participants who received any amount of study drug in Cohort 4. Number of participants analysed signifies participants evaluable for this outcome.||kg||Standard Error|Least Squares Mean
829206|NCT01225211|Secondary|Cohort 4: Absolute Change From Baseline in Body Mass Index (BMI) at Day 56|BMI was defined as weight in kilogram (kg) divided by height*height in square meter (m^2).|Cohort 4: Baseline, Day 56|Cohort 4 Full Analysis Set included all randomized participants who received any amount of study drug in Cohort 4. Number of participants analysed signifies participants evaluable for this outcome.||kg/m^2||Standard Error|Least Squares Mean
829207|NCT01225211|Secondary|Cohort 4: Absolute Change From Baseline in CFQ-R Respiratory Domain Score at Day 56|CFQ-R respiratory domain is defined in Outcome Measure 17.|Cohort 4: Baseline, Day 56|Cohort 4 Full Analysis Set included all randomized participants who received any amount of study drug in Cohort 4. Number of participants analysed signifies participants evaluable for this outcome.||units on a scale||Standard Error|Least Squares Mean
829208|NCT01225211|Secondary|Cohort 2 and 3: Absolute Change From Day 28 in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score at Day 56|The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for subjects with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.|Cohort 2 and 3: Day 28, Day 56|Cohort 2 and 3 Full Analysis Set included all randomized participants who received at least 1 dose of study drug in Cohort 2 or 3. Number of participants analysed signifies participants evaluable for this outcome.||units on a scale||95% Confidence Interval|Least Squares Mean
829209|NCT01225211|Secondary|Cohort 4: Relative Change From Baseline in Percent Predicted FEV1 at Day 56|FEV1 and ppFEV1 are defined in Outcome Measure 6.|Cohort 4: Baseline, Day 56|Cohort 4 Full Analysis Set included all randomized participants who received any amount of study drug in Cohort 4. Number of participants analysed signifies participants evaluable for this outcome.||percent change||Standard Error|Least Squares Mean
829210|NCT01225211|Secondary|Cohort 2 and 3: Relative Change From Baseline in FEV1 at Day 28 and 56|FEV1 and ppFEV1 are defined in Outcome Measure 6.|Cohort 2 and 3: Baseline, Day 28 and 56|Cohort 2 and 3 Full Analysis Set included all randomized participants who received at least 1 dose of study drug in Cohort 2 or 3. Here, n = participants evaluable for specified category for each arm, respectively. Number of participants analysed signifies participants evaluable for this outcome.||percent change||95% Confidence Interval|Least Squares Mean
829211|NCT01225211|Secondary|Cohort 2 and 3: Absolute Change From Baseline in ppFEV1 at Day 28 and 56|FEV1 and ppFEV1 are defined in Outcome Measure 6.|Cohort 2 and 3: Baseline, Day 28 and 56|Cohort 2 and 3 Full Analysis Set included all randomized participants who received at least 1 dose of study drug in Cohort 2 or 3. Here, n = participants evaluable for specified category for each arm, respectively. Number of participants analysed signifies participants evaluable for this outcome.||percent predicted of FEV1||95% Confidence Interval|Least Squares Mean
829212|NCT01225211|Secondary|Cohort 2 and 3: Relative Change From Day 28 in ppFEV1 at Day 56|FEV1 and ppFEV1 are defined in Outcome Measure 6.|Cohort 2 and 3: Day 28, Day 56|Cohort 2 and 3 Full Analysis Set included all randomized participants who received at least 1 dose of study drug in Cohort 2 or 3. Number of participants analysed signifies participants evaluable for this outcome.||percent change||95% Confidence Interval|Least Squares Mean
829411|NCT01226719|Secondary|To Determine the Acute Toxicity Produced by This Regimen.|The analyses of safety will be based on the frequency of adverse events and their severity for patients who received at least one dose of study treatment.|18 months|All patients on study||participants|||Number
829213|NCT01225211|Secondary|Cohort 2 and 3: Absolute Change From Day 28 in ppFEV1 at Day 56|FEV1 and ppFEV1 are defined in Outcome Measure 6.|Cohort 2 and 3: Day 28, Day 56|Cohort 2 and 3 Full Analysis Set included all randomized participants who received at least 1 dose of study drug in Cohort 2 or 3. Number of participants analysed signifies participants evaluable for this outcome.||percent predicted of FEV1||95% Confidence Interval|Least Squares Mean
829214|NCT01225211|Secondary|Cohort 1: Absolute Change From Day 14 in ppFEV1 at Day 21|FEV1 and ppFEV1 are defined in Outcome Measure 6.|Cohort 1: Day 14, Day 21|Cohort 1 Full Analysis Set included all randomized participants who received at least 1 dose of study drug in Cohort 1. Number of participants analysed signifies participants evaluable for this outcome.||percent predicted of FEV1||95% Confidence Interval|Least Squares Mean
829215|NCT01225211|Secondary|Cohort 1: Absolute Change From Day 14 in FEV1 at Day 21|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.|Cohort 1: Day 14, Day 21|Cohort 1 Full Analysis Set included all randomized participants who received at least 1 dose of study drug in Cohort 1. Number of participants analysed signifies participants evaluable for this outcome.||liters||95% Confidence Interval|Least Squares Mean
829216|NCT01225211|Secondary|Cohort 4: Absolute Change From Baseline in Sweat Chloride at Day 56||Cohort 4: Baseline, Day 56|Cohort 4 Full Analysis Set included all randomized participants who received any amount of study drug in Cohort 4. Number of participants analysed signifies participants evaluable for this outcome.||mmol/L||Standard Error|Least Squares Mean
829217|NCT01225211|Secondary|Cohort 2 And 3: Absolute Change From Baseline in Sweat Chloride at Day 14||Cohort 2: Baseline, Day 14|Cohort 2 and 3 Full Analysis Set included all randomized participants who received at least 1 dose of study drug in Cohort 2 or 3. Number of participants analysed signifies participants evaluable for this outcome.||mmol/L||95% Confidence Interval|Least Squares Mean
829218|NCT01225211|Secondary|Cohort 1: Absolute Change From Baseline in Sweat Chloride at Day 14||Cohort 1: Baseline, Day 14|Cohort 1 Full Analysis Set included all randomized participants who received at least 1 dose of study drug in Cohort 1. Number of participants analysed signifies participants evaluable for this outcome.||mmol/L||95% Confidence Interval|Least Squares Mean
829219|NCT01225211|Primary|Cohort 4: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) at Day 56|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. ppFEV1 (predicted for age, gender, and height) was calculated using the Hankinson method.|Cohort 4: Baseline, Day 56|Cohort 4 Full Analysis Set included all randomized participants who received any amount of study drug in Cohort 4. Number of participants analysed signifies participants evaluable for this outcome.||percent predicted of FEV1||Standard Error|Least Squares Mean
829220|NCT01225211|Primary|Cohort 2 And 3: Absolute Change From Day 28 in Sweat Chloride at Day 56||Cohort 2 and 3: Day 28, Day 56|Cohort 2 and 3 Full Analysis Set included all randomized participants who received at least 1 dose of study drug in Cohort 2 or 3. Number of participants analysed signifies participants evaluable for this outcome.||mmol/L||95% Confidence Interval|Least Squares Mean
829221|NCT01225211|Primary|Cohort 1: Absolute Change From Day 14 in Sweat Chloride at Day 21||Cohort 1: Day 14, Day 21|Cohort 1 Full Analysis Set included all randomized participants who received at least 1 dose of study drug in Cohort 1. Number of participants analysed signifies participants evaluable for this outcome.||millimole per liter (mmol/L)||95% Confidence Interval|Least Squares Mean
829222|NCT01225211|Primary|Cohort 4: Safety and Tolerability Assessed by Number of Participants With AEs and SAEs|AEs and SAEs are defined in Outcome Measure 1.|Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)|Cohort 4 Safety Set included all participants who received at least 1 dose of study drug in Cohort 4.||participants|||Number
829223|NCT01225211|Primary|Cohort 2 and 3: Safety and Tolerability Based on Adverse Events (AEs)|Detailed description is provided in Outcome Measure 1. Results are reported separately for monotherapy period (Period 1: Day 1 to Day 28) and combination therapy period (Period 2: Day 29 to Day 56).|Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56)|Cohort 2 and 3 Safety Set included all participants who received at least 1 dose of study drug in Cohort 2 or 3. Number of participants analysed signifies participants evaluable for this outcome.||participants|||Number
829224|NCT01225211|Primary|Cohort 1: Safety and Tolerability Based on Adverse Events (AEs)|AE: any untoward medical occurrence in a participant during study; irrespective of relationship with treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after informed consent. AE includes serious AEs (SAEs) as well as Non-SAEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Number of participants with AEs and SAEs are reported. AE that started at/after initial dosing of study drug, or increased in severity after initial dosing of study drug is considered treatment-emergent. Results are reported separately for monotherapy period (Period 1: Day 1 to Day 14) and combination therapy period (Period 2: Day 15 to Day 21).|Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21)|Cohort 1 Safety Set included all participants who received at least 1 dose of study drug in Cohort 1. Number of participants analysed signifies participants evaluable for this outcome.||participants|||Number
829225|NCT01225263|Primary|Migraine Frequency: Change From Baseline 12-week Period to Weeks 13 to 24||Weeks 13 to 24|||days||Inter-Quartile Range|Median
829226|NCT01225263|Primary|Migraine Frequency: Change From Baseline 12-week Period to Weeks 1 to 12||Weeks 1 to 12|||days||Inter-Quartile Range|Median
829227|NCT01225289|Secondary|Peripheral Blood Mononucleated Cells (PBMCs) Proliferation Assay (BrdU Colorimetric)|difference of PBMCs proliferation stimulated with myelin oligodendrocyte glycoprotein (MOG), before and after of supplementation|first day and after 6 month|||absorbance units||Standard Error|Mean
829228|NCT01225289|Secondary|Difference of Retinol Binding Protein (RBP) / Transthyretin (TTR) Ratio, (Difference of RBP/ TTR Ratio), Before and After of Supplementation||first day and after 6 month|||ratio||Standard Error|Mean
829229|NCT01225289|Secondary|Difference of IL-4 Levels in Supernatant of Peripheral Blood Mononucleated Cells (PBMCs) Stimulated With Phytohemagglutinin (PHA), Before and After of Supplementation||first day and after 6 month|||pg/ml||Standard Error|Mean
829230|NCT01225289|Primary|Difference Serum Levels of High-sensitive C-reactive Protein (Hs-CRP), Before and After of Supplementation||first day and after 6 month|||mg/L||Standard Error|Mean
829235|NCT01225354|Primary|Self-esteem|Self-esteem change will be determined by patient self-evaluation using the Heatherton & Polivy State Self-Esteem (HPSS). The primary variable will be measured as improvement in self-esteem from baseline self-evaluations.|1 month post-optimal cosmetic result|All subjects completing indicated visit||Participants with improved self-esteem|||Number
829236|NCT01225354|Primary|Blinded Evaluations of First Impression|Upon completion of the study, 300 blinded evaluators will evaluate one of three binders comprised of a random visit photographs from baseline, optimal cosmetic result, and 1 month post optimal cosmetic result of each of the 20 subjects. The 10-point (1=Not at all to 10=Extremely well) First Impression Scales consisting of 8 criteria.|After the 1-month post optimal correction visit for subject 20||||||
829237|NCT01225549|Secondary|Changes in Sputum Eosinophils Differentials (Percentage)|The change form baseline in percentage of sputum eosinophils was assessed on Day 5 (post dose) ,Day 6 ([post dose] 7 hours post allergen challenge) and Day 7 ([post dose] 24 hours post allergen challenge)|Day 7 ([post dose] 24 hours post allergen challenge)|||Percentage||Standard Deviation|Mean
829238|NCT01225549|Secondary|Changes in Sputum Eosinophils Differentials (Percentage)|The change form baseline in percentage of sputum eosinophils was assessed on Day 5 (post dose) ,Day 6 ([post dose] 7 hours post allergen challenge) and Day 7 ([post dose] 24 hours post allergen challenge)|Day 6 ([post dose] 7 hours post allergen challenge)|||Percentage||Standard Deviation|Mean
829239|NCT01225549|Secondary|Changes in Sputum Eosinophils Differentials (Percentage)|The change form baseline in percentage of sputum eosinophils was assessed on Day 5 (post dose) ,Day 6 ([post dose] 7 hours post allergen challenge) and Day 7 ([post dose] 24 hours post allergen challenge)|Day 5 (post dose)|PD Analysis set||Percentage||Standard Deviation|Mean
829240|NCT01225549|Secondary|Airway Hyperresponsiveness by Assessment of Methacholine PC20|The methacholine challenge was performed on Day 1 (pre dose), Day 5 ([post dose] pre AC), and Day 7 ([post dose] 24 hours post AC)|Day 7 ([post-dose] 24 hours post allergen challenge)|||mg/mL||Full Range|Geometric Mean
829241|NCT01225549|Secondary|Airway Hyperresponsiveness by Assessment of Methacholine PC20|The methacholine challenge was performed on Day 1 (pre dose), Day 5 ([post dose] pre AC), and Day 7 ([post dose] 24 hours post AC)|Day 5 ([post-dose] pre allergen challenge)|||mg/mL||Full Range|Geometric Mean
829242|NCT01225549|Secondary|Airway Hyperresponsiveness by Assessment of Methacholine PC20|The methacholine challenge was performed on Day 1 (pre dose), Day 5 ([post dose] pre AC), and Day 7 ([post dose] 24 hours post AC)|Day 1 (pre-dose)|PD Analysis set||mg/mL||Full Range|Geometric Mean
829243|NCT01225549|Secondary|Area Under the Curve (AUC) for FEV1 Over 0-3 and 3-7 h Post Allergen Challenge|AUC was assessed as average percentage of FEV1 remaining 0 to 3 hours and 3 to 7 hours post allergen challenge compared to pre allergen challenge FEV1|From Randomization to end of treatment|PD Analysis set||Percentage||Full Range|Geometric Mean
829244|NCT01225549|Secondary|Early Allergic Response (EAR) by Assessment of Minimum Percentage of FEV1 0-3 h Post Allergen Challenge|Minimum Percentage of FEV1 over 0 to 3 hours post allergen challenge compared to pre allergen challenge FEV1|From Randomization to end of treatment|PD Analysis set||Percentage||Full Range|Geometric Mean
829245|NCT01225549|Primary|Late Allergic Response (LAR) by Assessment of Minimum Percentage of FEV1 3-7 Hours Post Allergen Challenge Compared to Pre Allergen Challenge FEV1|LAR was assessed on Day 6 as minimum percentage of FEV1 over 3 to 7 hours based on the analysis of the minimum percentage of FEV1 remaining over 3 to 7 hours post allergen challenge (post AC) compared to pre allergen challenge (pre AC) FEV1|From Randomization to end of treatment|PD Analysis set||Percentage||Full Range|Geometric Mean
829246|NCT01225562|Primary|Kaplan-Meier Estimate of the Percentage of Patients Who Experienced a TIMI Major Bleeding Within 3 Years From First Dose of Study Drug Units: Percentage of Patients|A Thrombolysis in Myocardial Infarction (TIMI) study group major bleeding is defined as any fatal bleeding (leading directly to death within 7 days), any intrcranial bleeding or any clinically overt signs of haemorrhage associated with a drop in Haemoglobin of >= 5g/dL. Events were adjudicated by a clinical events committee. Censoring ocurrs at 7 days following last dose of study drug. The Kaplan-Meier estimate reports the percentage of patients who experienced a TIMI Major bleeding within 3 years from first dose of study drug|First dosing up to 48 months|The safety analysis set defined as all patients who took at least one dose of study drug||Percentage of Patients|||Number
829247|NCT01225562|Secondary|Kaplan-Meier Estimate of the Percentage of Patients Who Died From Any Cause Within 3 Years From Randomization|Participants with death from any cause. If no event, censoring occurs at the earliest of the efficacy cut-off date 14 Sep 2014, withdrawal of consent or the last time point the particapant was known to be alive. Events were adjudicated by a blinded endpoint committee. The Kaplan-Meier estimate reports the percentage of patients who died from any cause within 3 years from randomization|Randomization up to 47 months|Intention to treat (ITT) population defined as all participants who were randomized to study treatment||Percentage of Patients|||Number
829248|NCT01225562|Secondary|Kaplan-Meier Estimate of the Percentage of Patients Who Experienced Cardiovascular Death (CV Death) Within 3 Years From Randomization|Participants with CV death. If no event, censoring occurs at the earliest of the efficacy cut-off date 14 Sep 2014, withdrawal of consent, non-CV death or at the last time point of complete clinical event assessment. Events were adjudicated by a blinded endpoint committee. The Kaplan-Meier estimate reports the percentage of patients who experienced CV Death within 3 years from randomization|Randomization up to 47 months|Intention to treat (ITT) population defined as all participants who were randomized to study treatment||Percentage of Patients|||Number
829249|NCT01225562|Primary|Kaplan-Meier Estimate of the Percentage of Patients Who Experienced Cardiovascular Death (CV Death), Myocardial Infarction (MI) or Stroke Within 3 Years From Randomization|Participants with CV death, MI or Stroke. If no event, censoring occurs at the earliest of the efficacy cut-off date 14 Sep 2014, withdrawal of consent, non-CV death or at the last time point of complete clinical event assessment. Events were adjudicated by a blinded endpoint committee. The Kaplan-Meier estimate reports the percentage of patients who experienced CV Death, MI or stroke within 3 years from randomization|Randomization up to 47 months|Intention to treat (ITT) population defined as all participants who were randomized to study treatment||Percentage of Patients|||Number
829281|NCT01225835|Secondary|Number of Frozen Oocytes at Pronuclear Stage|No more than three normally developed embryos were transferred 2-3 days after oocyte retrieval. Other normally developed embryos were frozen.|approximately day 14|Per protocol set of participants who had embryos transferred||oocytes||Standard Deviation|Mean
829250|NCT01225731|Primary|Number of Particpants Discontinuing Study Treatment Due to Adverse Events|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment. Participants may be discontinued from study drug due to adverse events, but remain on the study.|Up to 52 weeks|All particpants receiving at least one dose of study drug during the treatment period.||Participants|||Number
829251|NCT01225731|Primary|Number of Participants Experiencing Adverse Events|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.|Up to 72 weeks|All participants receiving at least one dose of study drug.||Participants|||Number
829252|NCT01225731|Secondary|Percentage of Participants Achieving a >=5 Point Reduction in DLQI at Week 16|The DLQI is a 10-item questionnaire that measures how much participant skin problems have affected their life. Responses range from 0=Not at all to 3=Very much. The DLQI is broken down into 6 subscales: Symptoms and feelings (range 0-6), Daily activities (range 0-6), Leisure (range 0-6), Work and school (range 0-3), Personal relationships (range 0-6), and Treatment (range 0-3). DLQI subscales were summed to yield the DLQI total score, which could range from 0 to 30. For both DLQI subscales and DLQI total score, a higher score indicated a greater negative impact on life.|Week 16|The FAS, all randomized participants who received >=1 dose of study drug and had a baseline and >=1 post-treatment efficacy measurement, and had data for this endpoint.||Percentage of participants|||Number
829253|NCT01225731|Secondary|Percentage of Participants Achieving DLQI Score of 0 or 1 at Week 16|The DLQI is a 10-item questionnaire that measures how much participant skin problems have affected their life. Responses range from 0=Not at all to 3=Very much. The DLQI is broken down into 6 subscales: Symptoms and feelings (range 0-6), Daily activities (range 0-6), Leisure (range 0-6), Work and school (range 0-3), Personal relationships (range 0-6), and Treatment (range 0-3). DLQI subscales were summed to yield the DLQI total score, which could range from 0 to 30. For both DLQI subscales and DLQI total score, a higher score indicated a greater negative impact on life.|Week 16|The FAS, all randomized participants who received >=1 dose of study drug and had a baseline and >=1 post-treatment efficacy measurement, and data for this endpoint, excluding all participants on the placebo arm.||Percentage of participants|||Number
829254|NCT01225731|Secondary|Mean Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16|The DLQI is a 10-item questionnaire that measures how much participant skin problems have affected their life. Responses range from 0=Not at all to 3=Very much. The DLQI is broken down into 6 subscales: Symptoms and feelings (range 0-6), Daily activities (range 0-6), Leisure (range 0-6), Work and school (range 0-3), Personal relationships (range 0-6), and Treatment (range 0-3). DLQI subscales were summed to yield the DLQI total score, which could range from 0 to 30. For both DLQI subscales and DLQI total score, a higher score indicated a greater negative impact on life.|Week 16|The FAS, all randomized participants who received >=1 dose of study drug and had a baseline and >=1 post-treatment efficacy measurement, and had data for this endpoint.||Score on a scale||95% Confidence Interval|Mean
829255|NCT01225731|Secondary|Percentage of Participants With PASI 50 Response at Week 16|The PASI score measures the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness, and scaling of the largest psoriatic area in that region producing a Lesion Score. The percentage of the area affected by disease is then estimated, ranging from 0 = no lesions to 6 = 90-100% of the region is covered providing an Area Score. Then, the Lesion Score and Area Score for each region are multiplied, producing 4 subtotals. The 4 region subtotals are multiplied by a standardized percentage of body surface area for that region (head = 0.1, trunk = 0.3, arms=0.2, and legs = 0.4); these four region calculations are added to provide the final PASI score, ranging from 0 = no disease to 72 = maximal disease). PASI 50 response was defined as >=50 % improvement in PASI score when compared to the baseline score.|Week 16|The FAS, all randomized participants who received >=1 dose of study drug and had a baseline and >=1 post-treatment efficacy measurement. The last non-missing post-baseline PASI score was carried forward (LOCF) unless the participant discontinued drug due to lack of efficacy, loss of response, or use of prohibited medications.||Percentage of participants|||Number
829256|NCT01225731|Secondary|Mean Change From Baseline in PASI Score at Weeks 12 and 16|The PASI score measures the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness, and scaling of the largest psoriatic area in that region producing a Lesion Score. The percentage of the area affected by disease is then estimated, ranging from 0 = no lesions to 6 = 90-100% of the region is covered providing an Area Score. Then, the Lesion Score and Area Score for each region are multiplied, producing 4 subtotals. The 4 region subtotals are multiplied by a standardized percentage of body surface area for that region (head = 0.1, trunk = 0.3, arms=0.2, and legs = 0.4); these four region calculations are added to provide the final PASI score, ranging from 0 = no disease to 72 = maximal disease).|Baseline and Weeks 12 and 16|The FAS, all randomized participants who received >=1 dose of study drug and had a baseline and >=1 post-treatment efficacy measurement, and data for Week 12 and Week 16.||Score on a scale||95% Confidence Interval|Mean
829257|NCT01225731|Secondary|PASI 75 Response Rate by Time|The PASI score measures the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness, and scaling of the largest psoriatic area in that region producing a Lesion Score. The percentage of the area affected by disease is then estimated, ranging from 0 = no lesions to 6 = 90-100% of the region is covered providing an Area Score. Then, the Lesion Score and Area Score for each region are multiplied, producing 4 subtotals. The 4 region subtotals are multiplied by a standardized percentage of body surface area for that region (head = 0.1, trunk = 0.3, arms=0.2, and legs = 0.4); these four region calculations are added to provide the final PASI score, ranging from 0 = no disease to 72 = maximal disease).PASI 75 response was defined as >=75% improvement in PASI score when compared to the baseline score at Week 2, 4, 6, 8, 12, or 16.|Up to 16 Weeks|The FAS, all randomized participants who received >=1 dose of study drug and had a baseline and >=1 post-treatment efficacy measurement. and data for the specific Week.||Percentage of participants|||Number
829337|NCT01226043|Secondary|Change in Fasting Plasma Glucose (FPG)||From week 4 (baseline for re-randomization phase) to week 10 (end of re-randomization phase)|The mITT population for Re-randomization and Observational Phases consisted of all patients who were re-randomized, received at least one dose of Lantus after re-randomization, and had both a re-randomization baseline assessment and at least one post re-randomization assessment of FPG measured during the on-treatment period.||mg/dL||Standard Error|Least Squares Mean
829258|NCT01225731|Secondary|Percentage of Participants With PASI 100 Response at Week 16|The PASI score measures the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness, and scaling of the largest psoriatic area in that region producing a Lesion Score. The percentage of the area affected by disease is then estimated, ranging from 0 = no lesions to 6 = 90-100% of the region is covered providing an Area Score. Then, the Lesion Score and Area Score for each region are multiplied, producing 4 subtotals. The 4 region subtotals are multiplied by a standardized percentage of body surface area for that region (head = 0.1, trunk = 0.3, arms=0.2, and legs = 0.4); these four region calculations are added to provide the final PASI score, ranging from 0 = no disease to 72 = maximal disease). PASI 100 response was defined as 100 % improvement in PASI score when compared to the baseline score.|Week 16|The FAS, all randomized participants who received >=1 dose of study drug and had a baseline and >=1 post-treatment efficacy measurement, and data fior this endpoint||Percentage of participants|||Number
829259|NCT01225731|Secondary|Percentage of Participants With PASI 90 Response at Week 16|The PASI score measures the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness, and scaling of the largest psoriatic area in that region producing a Lesion Score. The percentage of the area affected by disease is then estimated, ranging from 0 = no lesions to 6 = 90-100% of the region is covered providing an Area Score. Then, the Lesion Score and Area Score for each region are multiplied, producing 4 subtotals. The 4 region subtotals are multiplied by a standardized percentage of body surface area for that region (head = 0.1, trunk = 0.3, arms=0.2, and legs = 0.4); these four region calculations are added to provide the final PASI score, ranging from 0 = no disease to 72 = maximal disease). PASI 90 response was defined as >=90 % improvement in PASI score when compared to the baseline score.|Week 16|The FAS, all randomized participants who received >=1 dose of study drug and had a baseline and >=1 post-treatment efficacy measurement, and data for this endpoint.||Percentage of participants|||Number
829260|NCT01225731|Secondary|Percentage of Participants With Physician’s Global Assessment (PGA) of “Cleared” or “Minimal” at Week 16|The PGA is used to determine the overall severity of a subject’s psoriasis lesions at a given time point. Overall lesions will be graded for induration, erythema, and scaling on a scale from 0 to 5. The sum of the 3 scales will be divided by 3 to obtain the PGA score. PGA is assessed as: 0= Cleared, except for residual discoloration. 1= Minimal, majority of lesions have individual scores that average . 2 =Mild, majority of lesions have individual scores that average 2. 3= Modreate, majority of lesions have individual scores that average 3. 4= Marked, majority of lesions have individual scores that average 4. 5= Severe, majority of lesions have individual scores that average 5.|Week 16|The Full Analysis Set (FAS), all randomized participants who received >=1 dose of study drug and had a baseline and >=1 post-treatment efficacy measurement. The last non-missing post-baseline PGA value was carried forward (LOCF) unless the participant discontinued drug due to lack of efficacy, loss of response, or use of prohibited medications.||Percentage of participants|||Number
829261|NCT01225731|Secondary|Percentage of Participants With a PASI 75 Response at Week 12|The PASI score measures the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness, and scaling of the largest psoriatic area in that region producing a Lesion Score. The percentage of the area affected by disease is then estimated, ranging from 0 = no lesions to 6 = 90-100% of the region is covered providing an Area Score. Then, the Lesion Score and Area Score for each region are multiplied, producing 4 subtotals. The 4 region subtotals are multiplied by a standardized percentage of body surface area for that region (head = 0.1, trunk = 0.3, arms=0.2, and legs = 0.4); these four region calculations are added to provide the final PASI score, ranging from 0 = no disease to 72 = maximal disease). PASI 75 response was defined as >=75% improvement in PASI score when compared to the baseline score.|Week 12|The FAS, all randomized participants who received >=1 dose of study drug and had a baseline and >=1 post-treatment efficacy measurement. The last non-missing post-baseline PASI score was carried forward (LOCF) unless the participant discontinued drug due to lack of efficacy, loss of response, or use of prohibited medications.||Percentage of participants|||Number
829262|NCT01225731|Primary|Percentage of Participants With a Psoriasis Area and Severity Index (PASI)75 Response at Week 16|The PASI score measures the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness, and scaling of the largest psoriatic area in that region producing a Lesion Score. The percentage of the area affected by disease is then estimated, ranging from 0 = no lesions to 6 = 90-100% of the region is covered providing an Area Score. Then, the Lesion Score and Area Score for each region are multiplied, producing 4 subtotals. The 4 region subtotals are multiplied by a standardized percentage of body surface area for that region (head = 0.1, trunk = 0.3, arms=0.2, and legs = 0.4); these four region calculations are added to provide the final PASI score, ranging from 0 = no disease to 72 = maximal disease). PASI 75 response was defined as >=75% improvement in PASI score when compared to the baseline score.|Week 16|The Full Analysis Set (FAS), all randomized participants who received >=1 dose of study drug and had a baseline and >=1 post-treatment efficacy measurement. The last non-missing post-baseline PASI score was carried forward (LOCF) unless the participant discontinued drug due to lack of efficacy, loss of response, or use of prohibited medications.||Percentage of participants|||Number
829263|NCT01225822|Secondary|Area Under the Plasma Concentration-time Curve During a Dosing Interval|Area under the plasma concentration-time curve during a dosing interval (at steady-state). The AUC0-12h (for b.i.d. treatment regimens) and AUC0-24h (300 mg q.d.) after the first dose on day of surgery calculated by extrapolation using the elimination rate constant, reported only if the extrapolated fraction of AUC was less than 30 % of the total AUC.|up to day 8+/-2 days visit|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
829264|NCT01225822|Secondary|Plasma Concentration (Cmax) of Dabigatran|"Maximum plasma concentration of Dabigatran (at steady-state) and Pre-dose plasma concentrations at steady state.
Cmax represents the maximum concentration of Dabigatran in plasma. Cmax,ss represents the maximum concentration of Dabigatran in plasma at steady state.
Cpre,ss represents pre-dose concentration of Dabigatran in plasma at steady state"|Day 1 to end of treatment|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
829350|NCT01226121|Secondary|Percentage of Patients Obtaining Clinical Success at 90 Days (<=5 Degree Residual Contracture)||90 days|||percentage of patients|||Number
829351|NCT01226121|Primary|Percentage of Patients With Clinical Improvement (> 50% Reduction in Contracture)||30 days after injection|||percentage of participants|||Number
829265|NCT01225822|Secondary|Laboratory Analyses|"Number of patients with possible clinically significant abnormalities, i.e. with values out of normal range.
Normal ranges are defined as:
Haematocrit [%]: (0.35-0.45) for women and (0.39−0.51) for men Haemoglobin [g/dL]: (11.6−15.4) for women and (13.2−17.3) for men White Blood Cell count [10^9/L]: (4-10.3) for women and (3.9−10.3) for men Platelets [10^9/L]: (145-420) for women and men Sodium [mmol/L]: (135-146) for women and men Potassium [mmol/L]: (3.5-5) for women and men Aspartate aminotransferase (AST) [U/L]: (11-37) for women and (11-39) for men Alanine aminotransferase (ALT) [U/L]: (8-43) for women and (8-45) for men Alkaline Phosphatase [U/L]: (36-118) for women and (35-123) for men Creatinine [mg/dL]: (0.57-1.06)for women and (0.72−1.3) for men Bilirubin, total [mg/dL]: (0.22-1.28) for women and men Uric acid [mg/dL]: (2.4-6.47) for women and men"|Screening to end of treatment|Safety Set (SAFE) population. This included all randomised patients who were treated and who had any available data||participants|||Number
829266|NCT01225822|Secondary|Number of Participants With Clinically Significant, Minor or Any Bleeding Events|"Number of participants with Clinically Significant, minor or any bleeding events. Clinically significant bleeding events are defined as
Spontaneous skin haematoma larger than >25 cm²
Wound haematoma >100 cm²
Spontaneous nose bleed >5 minutes
Macroscopic haematurea, either spontaneous or lasting more than 24 hours if associated with an intervention
Spontaneous rectal bleeding (more than spot on toilet paper)
Gingival bleeding >5 minutes
Any other bleeding event considered as clinically significant by the investigator All other bleeding events that did not fulfil the criteria of MBE or clinically significant bleeding event were classified as minor bleeding events."|Treatment period (up to day 8+/-2 days visit)|Safety Set (SAFE) population. This included all randomised patients who were treated and who had any available data||participants|||Number
829267|NCT01225822|Secondary|Rate of Transfusions Due to Bleedings|Percentage of patients requiring transfusions due to bleeding .Rate of need of transfusion were to be analysed using a logistic regression with treatment and centre.|Day 1 (Day of surgery)|Safety Set (SAFE) population. This included all randomised patients who were treated and who had any available data||Percentage of patients|||Number
829268|NCT01225822|Secondary|Volume of Blood Loss|Volume of blood loss was to be analysed using an analysis of variance (ANOVA), which included treatment and centre.|Day 1 (Day of surgery)|Safety Set (SAFE) population. This included all randomised patients who were treated and who had any available data||ml||Standard Deviation|Mean
829269|NCT01225822|Primary|Number of Participants With Major Bleeding Events (MBE)||From approximately 14 days prior to surgery to 4-6 weeks post surgery|Safety Set (SAFE) population. This included all randomised patients who were treated and who had any available data||participants|||Number
829270|NCT01225822|Secondary|Number of Participants With Proximal DVT|Deep venous thrombosis (DVT) (proximal) as detected by routine bilateral venography on day 8 +/- 2, plus symptomatic proximal DVT confirmed by venography during the treatment period|Treatment period (up to day 8+/-2 days visit)|Full Analysis Set (FAS) population. This included all randomised patients who had at least one subcutaneous injection and one oral dose of study medication and with confirmed VTE data post surgery||participants|||Number
829271|NCT01225822|Secondary|Number of Participants With Proximal DVT, PE (Pulmonary Embolism) and VTE Related Mortality|Deep venous thrombosis (DVT) (proximal) as detected by routine bilateral venography on day 8 +/- 2, plus symptomatic proximal DVT confirmed by venography during the treatment period or PE confirmed by objective testing plus VTE related mortality|Treatment period (up to day 10)|Full Analysis Set (FAS) population. This included all randomised patients who had at least one subcutaneous injection and one oral dose of study medication and with confirmed VTE data post surgery||participants|||Number
829272|NCT01225822|Secondary|Number of Participants With VTE Events and All Cause Mortality|Deep venous thrombosis (DVT) (proximal and distal) as detected by routine bilateral venography on day 8 +/- 2, plus symptomatic DVT confirmed by venography during the treatment period or Pulmonary Embolism (PE) confirmed by objective testing and all deaths.|Treatment period (up to day 8+/-2 days visit)|Full Analysis Set (FAS) population. This included all randomised patients who had at least one subcutaneous injection and one oral dose of study medication and with confirmed VTE data post surgery||participants|||Number
829273|NCT01225822|Primary|Number of Participants With Venous Thromboembolic (VTE) Events|Deep vein thrombosis (DVT) (proximal and distal) as detected by routine bilateral venography on day 8 +/- 2, plus symptomatic DVT confirmed by venography during the treatment period or PE confirmed by objective testing|Treatment period (up to day 8+/-2 days visit)|Full Analysis Set (FAS) population. This included all randomised patients who had at least one subcutaneous injection and one oral dose of study medication and with confirmed VTE data post surgery||participants|||Number
829274|NCT01225835|Secondary|Summary of Pregnancy Outcome|Pregnancy outcomes were reported at the optional long-term follow up visit.|up to 10 months|Per protocol set of participants who reported information during the optional long-term follow up visit.||participants|||Number
829275|NCT01225835|Secondary|Percentage of Participants With Clinical Pregnancy 6 Weeks After the First Positive Pregnancy Test|A pelvic ultrasound scan was performed approximately 6 weeks after the first positive pregnancy test and the presence of an active foetal heart action indicated a clinical pregnancy.|approximately 2.5 months from start of study, 6 weeks after first positive pregnancy test|Per protocol set||percentage of participants|||Number
829276|NCT01225835|Secondary|Number of Ampoules of Gonadotrophins Used|Number of ampoules of gonadotrophins used with the goal of reaching hCG criteria. Each ampoule contained 75 IU of either menotrophin or follitrophin alpha.|Day 1 up to Day 12|Per protocol set||ampoules||Standard Deviation|Mean
829277|NCT01225835|Secondary|Number of Days Stimulated With Gonadotrophins|Number of days in which gonadotrophins were administered until hCG criteria were met. If hCG criteria were not met by day 13, the participant was withdrawn from the study.|Day 1 up to Day 12|Per protocol set||days||Standard Deviation|Mean
829278|NCT01225835|Secondary|Percentage of Participants With Successful Embryo Transfer||approximately day 18|Per protocol set||percentage of participants|||Number
829279|NCT01225835|Secondary|Estradiol (E2) Levels on Day of hCG Administration||approximately day 10|Per protocol set. Five participants from each treatment arm were missing blood samples.||ng/ml||Standard Deviation|Mean
829280|NCT01225835|Secondary|Endometrial Thickness on Day of hCG Administration|Endometrial thickness was assessed by pelvic ultrasound on the day of hCG administration.|approximately day 10|Per protocol set of participants. One participant in the Follitrophin Alpha arm was missing a measurement.||mm||Standard Deviation|Mean
829282|NCT01225835|Secondary|Best Quality of an Embryo Transferred|"Embryo quality was measured by the following grades:
Grade 1: Evenly sized cells, regular cleavage, no fragmentation
Grade 2: Regular or slightly irregular cleavage, <=20% fragmentation
Grade 2.5: Regular or slightly irregular cleavage, >20%and <=50% fragmentation
Grade 3: Irregular cleavage, >50% fragmentation, >1 intact cell
Grade 4: Extensive fragmentation, only 1 cell intact
Grade 5: Totally fragmented, no viable cells.
Grade 1 represents the healthiest embryos and Grade 5 embryos are not viable."|approximately day 14|Per protocol set of participants who had embryos transferred||participants|||Number
829283|NCT01225835|Secondary|Number of Embryos Transferred|Mean number of embryos transferred 2-3 days following oocyte retrieval.|approximately day 14|The per-protocol (PP) set who had embryos transferred. PP set is defined as participants of the full analysis set without any major protocol violation (i.e., any deviation which was likely to bias the assessment of the primary endpoint).||embryos||Standard Deviation|Mean
829284|NCT01225835|Secondary|Number of Participants With Pronuclear Stage Oocytes at Each Quality Grade|"The count of participants with different quality grades of pronuclear stage oocytes is offered. Pronuclear stage oocytes are categorized into seven grades (0A, 0B, 1-5) representing different patterns of pronuclear morphology, according to the German Pronuclear Morphology Study Group. 0A is the highest quality oocyte and grade 5 is the lowest quality.
Participants can have pronuclear stage oocytes of different grades and therefore are counted more than once."|approximately day 13|The per-protocol (PP) set -- defined as participants of the full analysis set without any major protocol violation (i.e., any deviation which was likely to bias the assessment of the primary endpoint).||participants|||Number
829285|NCT01225835|Secondary|Number of Pronuclear Oocytes|Pronuclear oocytes are fertilized oocytes.|approximately day 13 after study start|The per-protocol (PP) set of participants with non-missing values.||oocytes||Standard Deviation|Mean
829286|NCT01225835|Secondary|Number of Cumulus-oocyte Complexes Retrieved|Cumulus-oocyte complexes are oocytes with surrounding cumulus cells.|approximately day 12 after study start|The per-protocol (PP) set of participants with non-missing values.||oocytes||Standard Deviation|Mean
829287|NCT01225835|Secondary|Average Follicle Diameter at hCG Administration||approximately day 10|The per-protocol (PP) set of participants with non-missing values.||mm||Standard Deviation|Mean
829288|NCT01225835|Secondary|Number of Follicles at hCG Administration|Number of follicles >=17 mm diameter detected by pelvic ultrasound examination at day of hCG administration.|approximately day 10|The per-protocol (PP) set of participants with non-missing values. PP set is defined as participants of the full analysis set without any major protocol violation (i.e., any deviation which was likely to bias the assessment of the primary endpoint).||follicles||Standard Deviation|Mean
829289|NCT01225835|Secondary|Percentage of Participants With Ongoing Pregnancy|Ongoing pregnancy is defined as having a positive foetal heart action nine or more weeks after the first positive pregnancy test.|approximately 3.5 months from study start (at least 9 weeks after first positive pregnancy test)|The per-protocol (PP) set -- defined as participants of the full analysis set without any major protocol violation (i.e., any deviation which was likely to bias the assessment of the primary endpoint).||percentage of participants|||Number
829290|NCT01225835|Secondary|Receiver Operating Characteristic (ROC) Analysis of Progesterone as Predictor for Ongoing Pregnancy Rate at Day 7 and Day of hCG Administration|The influence of the progesterone level on the ongoing pregnancy rate (in relation to all randomized patients) was determined by means of the receiver operating characteristic (ROC) curve. Youden's Index (sensitivity + specificity -1) has a range of 0-1, with 0.5 indicating a random effect.|Day 7, approximately Day 10 (hCG Administration)|Full analysis set||Youden's index|||Number
829291|NCT01225835|Primary|Serum Progesterone (P4) Level in the Morning of the Day of Human Chorionic Gonadotrophin (hCG) Administration|Ovulation induction was performed by administration of hCG once three follicles >=17 mm diameter as shown by pelvic ultrasound examination. This outcome compares the serum progesterone level the morning prior to hCG administration across treatment arm, and also by age stratum (<39 years and >=39 years).|approximately day 10|Full analysis set||ng/ml||Standard Deviation|Mean
829297|NCT01225926|Primary|Monocular Uncorrected Distance Visual Acuity (Monocular UCDVA) at Month 3|Uncorrected visual acuity (i.e., visual acuity measured without spectacles or other visual corrective devices) was assessed using Early Treatment Diabetic Retinopathy Study charts at 100% contrast and measured in logarithm of the minimum angle of resolution (logMAR). Each eye was assessed, and both eyes contributed to the mean. LogMAR 0.00 is equivalent of 20/20 and LogMAR 1.0 is equivalent of 20/200. A more negative logMAR value would indicate a greater improvement in visual acuity.|Month 3|Per protocol: All subjects who received IOLs in both eyes and followed the protocol with no major protocol deviations.||logMAR||Standard Deviation|Mean
829511|NCT01220128|Primary|Number of Subjects With Anemia, by CTCAE Maximum Grade||During the treatment period and up to 30 days post last vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.||Subjects|||Number
829298|NCT01225952|Secondary|Monocular Mesopic Contrast Sensitivity With Glare(18 Cycles/Degree)|In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 4 (day 120-180)|Full analysis set||log contrast sensitivity units|Participants|Standard Deviation|Mean
829299|NCT01225952|Secondary|Monocular Mesopic Contrast Sensitivity With Glare(12 Cycles/Degree)|In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 4 (day 120-180)|Full analysis set||log contrast sensitivity units|Participants|Standard Deviation|Mean
829300|NCT01225952|Secondary|Monocular Mesopic Contrast Sensitivity With Glare(6 Cycles/Degree)|In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 4 (day 120-180)|Full analysis set||log contrast sensitivity units|Participants|Standard Deviation|Mean
829301|NCT01225952|Secondary|Monocular Mesopic Contrast Sensitivity With Glare(3 Cycles/Degree)|In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 4 (day 120-180)|Full analysis set||log contrast sensitivity units|Participants|Standard Deviation|Mean
829302|NCT01225952|Secondary|Monocular Mesopic Contrast Sensitivity With Glare(1.5 Cycles/Degree)|In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 4 (day 120-180)|Full analysis set||log contrast sensitivity units|Participants|Standard Deviation|Mean
829303|NCT01225952|Secondary|Monocular Mesopic Contrast Sensitivity With Glare(18 Cycles/Degree)|In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 3 (day 30-60)|Full analysis set||log contrast sensitivity units|Participants|Standard Deviation|Mean
829304|NCT01225952|Secondary|Monocular Mesopic Contrast Sensitivity With Glare(12 Cycles/Degree)|In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 3 (day 30-60)|Full analysis set||log contrast sensitivity units|Participants|Standard Deviation|Mean
829305|NCT01225952|Secondary|Monocular Mesopic Contrast Sensitivity With Glare(6 Cycles/Degree)|In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 3 (day 30-60)|Full analysis set||log contrast sensitivity units|Participants|Standard Deviation|Mean
829306|NCT01225952|Secondary|Monocular Mesopic Contrast Sensitivity With Glare (3 Cycles/Degree)|In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 3 (day 30-60)|Full analysis set||log contrast sensitivity units|Participants|Standard Deviation|Mean
829307|NCT01225952|Secondary|Monocular Mesopic Contrast Sensitivity With Glare(1.5 Cycles/Degree)|In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 3 (day 30-60)|Full analysis set||log contrast sensitivity units|Participants|Standard Deviation|Mean
829308|NCT01225952|Secondary|Binocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree)|In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 4 (day 120-180)|Full Analysis Set||log contrast sensitivity units||Standard Deviation|Mean
829352|NCT01226420|Secondary|Safety of Alefacept Infusions in Patients With Chronic GVHD.|Assess the safety of alefacept in this patient population. The number of adverse events (including hematological and non-hematological safety events) will be used for safety assessment.|2 years|All enrolled subjects were included in the Analysis of Safety Events||Total adverse events|||Number
829309|NCT01225952|Secondary|Binocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree)|In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 4 (day 120-180)|Full Analysis Set||log contrast sensitivity units||Standard Deviation|Mean
829310|NCT01225952|Secondary|Binocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree)|In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 4 (day 120-180)|Full Analysis Set||log contrast sensitivity units||Standard Deviation|Mean
829311|NCT01225952|Secondary|Binocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree)|In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 4 (day 120-180)|Full Analysis Set||log contrast sensitivity units||Standard Deviation|Mean
829312|NCT01225952|Secondary|Binocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree)|In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 3 (day 30-60)|Full Analysis Set||log contrast sensitivity units||Standard Deviation|Mean
829313|NCT01225952|Secondary|Binocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree)|In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 3 (day 30-60)|Full Analysis Set||log contrast sensitivity units||Standard Deviation|Mean
829314|NCT01225952|Primary|Monocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree)|A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 4 (day 120-180)|||log contrast sensitivity units|Participants|Standard Deviation|Mean
829315|NCT01225952|Primary|Monocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree)|A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 4 (day 120-180)|||log contrast sensitivity units|Participants|Standard Deviation|Mean
829316|NCT01225952|Primary|Monocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree)|A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 4 (day 120-180)|||log contrast sensitivity units|Participants|Standard Deviation|Mean
829317|NCT01225952|Primary|Monocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree)|A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 4 (day 120-180)|||log contrast sensitivity units|Participants|Standard Deviation|Mean
829318|NCT01225952|Primary|Monocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree)|A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 3 (day 30-60)|Full Analysis Set, non-missing||log contrast sensitivity units|Participants|Standard Deviation|Mean
829319|NCT01225952|Primary|Monocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree)|A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 3 (day 30-60)|Full Analysis Set, non-missing||log contrast sensitivity units|Participants|Standard Deviation|Mean
829320|NCT01225952|Secondary|Binocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree)|In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 3 (day 30-60)|Full Analysis Set||log contrast sensitivity units||Standard Deviation|Mean
829321|NCT01225952|Secondary|Binocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree)|In two eye (Binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 3 (day 30-60)|Full Analysis Set||log contrast sensitivity units||Standard Deviation|Mean
829322|NCT01225952|Primary|Monocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree)|A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 3 (day 30-60)|Full Analysis Set, non-missing||log contrast sensitivity units|Participants|Standard Deviation|Mean
829323|NCT01225952|Primary|Monocular Mesopic Contrast Sensitivity Without Glare (1.5, 3 Cycles/Degree)|A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 3 (day 30-60)|Full Analysis Set||log contrast sensitivity units|Participants|Standard Deviation|Mean
829324|NCT01225991|Secondary|Connor-Davidson Resilience Scale (CD-RISC)|Resilience: the Connor-Davidson Resilience scale (CD-RISC) quantifies stress coping ability.|Week 1 and 12||||||
829325|NCT01225991|Secondary|Profile of Mood States (POMS)|Depressive symptoms: Repeated assessment of depressive symptoms severity will be made using the Profile of Mood States (POMS).|Week 1 and 12||||||
829326|NCT01225991|Secondary|(UKU) Side Effects Rating Scale Profile|Will rate the frequency and intensity of emerging adverse events.|12 weeks- each visit||||||
829327|NCT01225991|Secondary|Visual Analogue Scale to Evaluate Fatigue (VAS-F)|Fatigue: Repeated assessment of fatigue severity across the day will utilize the Visual Analogue Scale to Evaluate Fatigue (VAS-F).|Week 1 and 12||||||
829328|NCT01225991|Primary|Pain Rating Index|Pain & Stiffness: Repeated assessments of pain and stiffness across the day will utilize the Pain Rating Index (PRI), consisting of the sum of the ranked values associated with adjectives depicting the severity of pain from the McGill Pain Questionnaire (MPQ). Sixty joints will be evaluated on a scale from 0 (none) to 3 (severe), to indicate the extent of pain/tenderness and swelling. The final score was summed for this measure with a range from 0 (no pain) to 45 (worst possible pain).|Change score at baseline and 12 weeks|||units on a scale||Standard Deviation|Mean
829329|NCT01226043|Other Pre-specified|Number of Patients With Hypoglycemic Events|The hypoglycemic event was to be recorded on the electronic case report form hypoglycemia page and had to fit in one of the following categories: Mild-to-moderate hypoglycemia (36 mg/dL ≤ Self Monitored Blood Glucose (SMBG) <70mg/dL), Severe hypoglycemia (assistance of another person is required, and either a recorded SMBG <36 mg/dL, or treatment with oral carbohydrates, intravenous glucose or glucagon with prompt response) or Hypoglycemia symptoms with or without SMBG values with a documented SMBG >70 mg/dL, or no recorded SMBG value. Only hypoglycemia events associated with coma, loss of consciousness or seizure were considered serious adverse event (SAEs).|each study phase (crossover, re-randomization, observational) up to 40 weeks|The safety population for each phase (crossover, re-randomization, observational) was the total treated population defined as all the patients who were randomized and exposed to at least one dose of Lantus during that phase.||participants having reported the event|||Number
829330|NCT01226043|Secondary|Percentage of Patients Who Discontinued Investigational Product During the Observational Phase||From week 10 to week 40 (observational phase)|Re-randomized population at week 4 and included in the observational phase at week 10 and exposed to at least one dose of the IP||percentage of patients|||Number
829331|NCT01226043|Secondary|Percentage of Patients Who Discontinued Investigational Product During the Re-randomization Phase||From week 4 to week 10 (re-randomization phase)|Re-randomized population at week 4 exposed to at least one dose of the IP||percentage of patients|||Number
829332|NCT01226043|Secondary|Percentage of Patients Who Discontinued Investigational Product (IP) During the Crossover Phase||From baseline to week 4 (crossover phase)|Randomized population (crossover phase) exposed to at least one dose of the IP||percentage of patients|||Number
829333|NCT01226043|Secondary|Time to First Observation of HbA1c <7%||From week 10 to week 40 (observational phase)|The mITT population for Re-randomization and Observational Phases consisted of all patients who were re-randomized, received at least one dose of Lantus after re-randomization, and had both a re-randomization baseline assessment and at least one post re-randomization assessment of HbA1c.||Days since Re-randomization (week 4)||95% Confidence Interval|Median
829334|NCT01226043|Secondary|Percentage of Patients Achieving HbA1c Goal|Percentage of patients achieving HbA1c < 7% at Week 40 (end of the observational phase)|measured at week 40 or at study discontinuation|Patients from the mITT population for Re-randomization and Observational Phases who had at least one post re-randomization assessment of HbA1c.||percentage of patients|||Number
829335|NCT01226043|Secondary|Change in Lantus Dose Injected Per Day||From week 4 (baseline for re-randomization phase) to week 10 (end of re-randomization phase)|The mITT population for Re-randomization and Observational Phases consisted of all patients who were re-randomized, received at least one dose of Lantus after re-randomization, and had both a re-randomization baseline assessment and at least one post re-randomization assessment of FPG.||U (insulin unit)||Standard Error|Least Squares Mean
829336|NCT01226043|Secondary|Percentage of Patients Achieving Fasting Plasma Glucose (FPG) <110 mg/dL||At week 10 (end of re-randomization phase)|The mITT population for Re-randomization and Observational Phases consisted of all patients who were re-randomized, received at least one dose of Lantus after re-randomization, and had a re-randomization baseline assessment FPG > or = 110 (week 4) and at least one post re-randomization assessment of FPG.||percentage of patients|||Number
829353|NCT01226420|Primary|Efficacy|Proportion of patients with a favorable response, defined as a complete or partial remission at week 12 as compared to baseline in subjects with steroid refractory cGVHD.|2 years|All enrolled subjects||participants|||Number
829338|NCT01226043|Secondary|Healthcare Professional's (HCP) Recommendation|"The overall recommendation score was obtained from the question 20d of the Healthcare Professional Questionnaire: “Overall, how strongly would you recommend each of the insulin delivery systems for your patients?”
5 points scale: from 1= Not Recommended to 5= Recommended"|At week 4 (end of crossover phase)|"The HCP Questionnaire analysis population consisted of HCPs:
who treated at least 1 randomized patient during the crossover phase and this(these) patient(s) received at least one dose of Lantus via both insulin delivery systems during the crossover phase
who completed the HCP Questionnaire."||units on a scale||Full Range|Median
829339|NCT01226043|Secondary|Patient Preference Composite Score|"The patient preference composite score was the sum of the scores of the 3 following individual preference questions from the Patient preference Questionnaire:
Question 14a: How strongly do you prefer each of these insulin delivery systems to control blood sugar?
Question 14b: If using insulin for the first time, how strongly would you prefer using each of these delivery systems to overcome reluctance to use insulin?
Question 14c: How strongly would you prefer each insulin delivery system for long-term use?
Each individual question scored from 1 to 5. The lowest score 1 indicated 'Not Preferred' and the highest score 5 indicated 'Always Preferred'. Therefore the total range of the composite score was 3 to 15."|At week 4 (end of crossover phase)|The modified intent-to-treat (mITT) population for the Patient Preference Questionnaire analysis consisted of all randomized patients who received at least one dose of Lantus via both insulin delivery systems and completed the questionnaire at Week 4. This analysis included patients who answered to the 3 questions 14a, 14b and 14c.||units on a scale||95% Confidence Interval|Least Squares Mean
829340|NCT01226043|Primary|Patient Overall Preference|"The patient preference was assessed in terms of the difference in scores obtained from the overall preference question 14d “Overall, what is your level of preference for each of the insulin delivery systems?”
5 points scale: from 1=Not preferred to 5= Always preferred"|At week 4 (end of crossover phase)|The modified intent-to-treat (mITT) population for the Patient Preference Questionnaire analysis consisted of all randomized patients who received at least one dose of Lantus via both insulin delivery systems and completed the questionnaire at Week 4. This analysis included patients who answered question 14d.||units on a scale||95% Confidence Interval|Least Squares Mean
829341|NCT01226095|Secondary|Number of Participants Who Experienced Adverse Events and Serious Adverse Events|Tolerability was assessed by collecting adverse events during the course of the study up to 30 days following the last dose of Brufen Retard. The number of participants experiencing a serious or non-serious adverse event is summarized. See the Reported Adverse Event section for details.|Baseline to 4 weeks|The tolerability population included all enrolled participants.||participants|||Number
829342|NCT01226095|Secondary|Number of Participants With the Ability to Carry Out Normal Activities at Each Visit|The number of participants who were able or unable to carry out normal activities was assessed at each visit.|Baseline, 2 weeks, and 4 weeks|Effectiveness data were analyzed using the intent-to-treat (ITT) and per-protocol (PP) populations, each of which consisted of all 519 enrolled participants.||participants|||Number
829343|NCT01226095|Secondary|Number of Participants With 80% Reduction From Baseline in Duration of Morning Stiffness at Visit 2 (2 Weeks of Treatment) and Visit 3 (4 Weeks of Treatment)|The number of participants who achieved an 80% reduction from baseline in morning stiffness was calculated at each visit.|2 and 4 weeks|Data were analyzed for all participants for which data were available.||participants|||Number
829344|NCT01226095|Primary|Number of Participants Who Improved (Reduced Pain), Had no Change (Equal Scores at Baseline and Visit), and Worsened (Increased Pain) at Visit 3 (After 4 Weeks of Treatment).|Scoring of day and night pain for the previous 24 hours was performed on a 9-point scale (0 = no pain to 8 = very severe pain) at each visit. The number of participants at Visit 3 (after 4 weeks of treatment) who improved (had reduced pain; from higher baseline score to lower Visit 3 score), had no change (equal scores at baseline and Visit 3), and worsened (increased pain; from lower baseline score to higher Visit 3 score) was calculated.|4 weeks|Effectiveness data were analyzed using the intent-to-treat (ITT) and per-protocol (PP) populations, each of which consisted of all 519 enrolled participants.||Participants|||Number
829345|NCT01226095|Secondary|Duration of Morning Stiffness|The duration of morning stiffness in minutes was assessed at each visit.|Baseline, 2 weeks, and 4 weeks|Effectiveness data were analyzed using the intent-to-treat (ITT) and per-protocol (PP) populations, however, only participants with available morning stiffness data were included in the analysis for each visit.||minutes||Standard Deviation|Mean
829346|NCT01226095|Secondary|Number of Participants Who Improved (Reduced), Had no Change (Equal at Baseline and Visit), and Worsened (Increased) in Joint Tenderness/Stiffness at Visit 2 (After 2 Weeks of Treatment) and Visit 3 (After 4 Weeks of Treatment).|Duration of morning stiffness at each visit was assessed and the number of participants who improved, had no change, or worsened at each visit, following 2 and 4 weeks of treatment (Visit 2 and Visit 3, respectively) was calculated.|2 and 4 weeks|Effectiveness data were analyzed using the intent-to-treat (ITT) and per-protocol (PP) populations, each of which consisted of all 519 enrolled participants.||Participants|||Number
829347|NCT01226095|Secondary|Number of Participants With Joint Tenderness/Stiffness at Each Visit|Joint tenderness/stiffness was measured using a 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe) at each visit.|Baseline, 2 weeks, and 4 weeks|Effectiveness data were analyzed using the intent-to-treat (ITT) and per-protocol (PP) populations, each of which consisted of all 519 enrolled participants.||participants|||Number
829348|NCT01226095|Secondary|Percent of Participant Compliance|The frequency with which the participant forgot to take treatment or changed dose/administration was determined by comparing the actual number of tablets taken by the participant to the scheduled number of tablets since the last visit. Results are presented in percent (0 - 100% scale, with 100% being perfect compliance and 0% being no compliance at all).|2 and 4 weeks|Compliance was calculated for all participants using the dose actually taken and the dose that should have been taken.||percentage of participant compliance|||Number
829349|NCT01226095|Primary|Day and Night Mean Pain Score for the Previous 24 Hours on a Nine-point Scale (0 = no Pain to 8 = Very Severe Pain) at Visit 3 (4 Weeks Following Treatment) in Comparison to Baseline.|Scoring of day and night pain for the previous 24 hours was performed on a nine-point scale (0 = no pain to 8 = very severe pain) at each visit and compared to baseline. The overall mean pain score was calculated for participants who completed the study at each visit.|Baseline and 4 weeks|Effectiveness data were analyzed using the intent-to-treat (ITT) and per-protocol (PP) populations, each of which consisted of all 519 enrolled participants.||units on a scale||Standard Deviation|Mean
829354|NCT01226459|Primary|Subject Assessment of Scalp Coverage|Subject assessment of scalp coverage at Week 24 was measured as change from Baseline on a 7-point scale where 0 meant no perceived change in scalp coverage, +1 to +3 indicated progressively increased levels of scalp coverage, and -1 to -3 indicated progressively decreased levels.|Week 24|Intent to Treat (ITT) population defined as all participants randomly assigned to a treatment group who received dispensed investigational product. Eighteen participants in vehicle foam group and 23 participants in minoxidil foam group had no scalp coverage information.||scores on a scale||Standard Deviation|Mean
829355|NCT01226459|Secondary|Target Area Hair Count|Number of hairs in the area being examined as measured by macrophotography.|Baseline to Week 12|Intent to Treat (ITT) population defined as all participants randomly assigned to a treatment group who received dispensed investigational product. Four participants in the vehicle foam group and 3 participants in the minoxidil foam group had no hair count information at Baseline.||hairs per centimeter squared||Standard Error|Mean
829356|NCT01226459|Primary|Target Area Hair Count|Number of hairs in the area being examined as measured by macrophotography.|Baseline to Week 24|Intent to Treat (ITT) population defined as all participants randomly assigned to a treatment group who received dispensed investigational product. Four participants in vehicle group and 3 participants in minoxidil foam group had no hair information at Baseline.||hairs per centimeter squared||Standard Deviation|Mean
829357|NCT01226511|Secondary|Percentage of Participants During the 18-Week Extension Period With Treatment-Emergent (New or Worsening) Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)|"The C-SSRS captured occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior: a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Reported as percentage of participants with treatment-emergent (new or worsening) suicidal behavior from baseline=(number of participants with changes compared to baseline/total number of participants at risk)*100."|10 weeks up to 28 weeks|Randomized participants with a C-SSRS suicidal behavior score at the last 2 visits in the acute treatment period and at least 1 C-SSRS suicidal behavior score during the extension treatment period, excluding 9 participants from 1 site with major quality issues.||percentage of participants|||Number
829358|NCT01226511|Secondary|Percentage of Participants During the 18-Week Extension Period With Treatment-Emergent (New or Worsening) Suicidal Ideation as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)|"The C-SSRS captured occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal ideation: a yes answer to any 1 of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Results reported as percentage of participants with treatment-emergent (new or worsening) suicidal ideation from baseline=(number of participants with changes compared to baseline/total number of participants at risk)*100."|10 weeks up to 28 weeks|Randomized participants with a C-SSRS suicidal ideation score <5 at the last 2 visits in the acute treatment period and at least 1 C-SSRS suicidal ideation score during the extension treatment period. Nine (9) participants from 1 site with major quality issues were excluded.||percentage of participants|||Number
829359|NCT01226511|Secondary|Change From 10-Week to 28-Week Endpoint in the Children's Global Assessment Scale (CGAS)|The CGAS was a clinician-rated assessment of general functioning. CGAS raw scores ranged from 1 (greatest impairment) to 100 (superior functioning). Lower scores indicated a lower level of functioning and greater impairment. Least squares (LS) mean from an analysis of covariance (ANCOVA) was adjusted for pooled investigator, baseline, and age category within reporting groups.|10 weeks, 28 weeks|Randomized participants with a CGAS score during the acute treatment period and at least 1 CGAS score during the extension treatment period [last observation carried forward (LOCF)], excluding 9 participants from 1 site with major quality issues.||units on a scale||Standard Error|Least Squares Mean
829360|NCT01226511|Secondary|Change From 10-Week to 28-Week Endpoint on the Clinical Global Impression of Severity (CGI-S) Scale|The CGI-S scale evaluated the severity of mental illness at the time of assessment. Scores ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill). Higher scores indicated a greater severity of illness. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach adjusted for pooled investigator, visit, baseline, age category, baseline*visit, and age category*visit within reporting groups.|10 weeks, 28 weeks|Randomized participants with a CGI-S score during the acute treatment period and at least 1 CGI-S score during the extension treatment period, excluding 9 participants from 1 site with major quality issues.||units on a scale||Standard Error|Least Squares Mean
829361|NCT01226511|Secondary|Change From 10-Week to 28-Week Endpoint on the Pediatric Anxiety Rating Scale (PARS) Severity Total Score Evaluated for All Symptoms Identified on the PARS Symptom Checklist Symptoms|PARS severity total score was assessed for all symptoms identified on the PARS symptom checklist. PARS severity total score was derived by summing 5 of 7 severity/impairment/interference items (2, 3, 5, 6, 7); each item ranged from 0 (none) to 5 (extreme severity/impairment/interference). PARS severity total scores ranged from 0 (none) to 25 (extreme severity), with a score of 15 indicating moderate illness severity. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach adjusted for pooled investigator, visit, baseline, age category, baseline*visit, and age category*visit within reporting groups.|10 weeks, 28 weeks|Randomized participants with a PARS severity total score during the acute treatment period and at least 1 PARS severity total score during the extension treatment period, excluding 9 participants from 1 site with major quality issues.||units on a scale||Standard Error|Least Squares Mean
829362|NCT01226511|Secondary|Change From 10-Week to 28-Week Endpoint in the Pediatric Anxiety Rating Scale (PARS) Severity Score Evaluated for Symptoms Identified on the Generalized Anxiety Subsection of the PARS Symptom Checklist|PARS severity score for GAD was assessed for all symptoms identified in the generalized anxiety section of the PARS symptom checklist. PARS severity score for GAD was derived by summing 5 of 7 severity/impairment/interference items (2, 3, 5, 6, 7); each item ranged from 0 (none) to 5 (extreme severity/impairment/interference). PARS severity scores for GAD ranged from 0 (none) to 25 (extreme severity), with a score of 15 indicating moderate illness severity. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach adjusted for pooled investigator, visit, baseline, age category, baseline*visit, and age category*visit within reporting groups.|10 weeks, 28 weeks|Randomized participants with a PARS severity score for GAD during the acute treatment period and at least 1 PARS severity score for GAD during the extension treatment period, excluding 9 participants from 1 site with major quality issues.||units on a scale||Standard Error|Least Squares Mean
829363|NCT01226511|Secondary|Percentage of Participants During the 10-Week Period With Treatment-Emergent (New or Worsening) Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)|"The C-SSRS captured occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior: a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Reported as percentage of participants with treatment-emergent (new or worsening) suicidal behavior from baseline=(number of participants with changes compared to baseline/total number of participants at risk)*100."|Baseline up to 10 weeks|Randomized participants with a baseline and at least 1 post-baseline C-SSRS suicidal behavior score during the acute treatment period, excluding 9 participants from 1 site with major quality issues.||percentage of participants|||Number
829364|NCT01226511|Secondary|Percentage of Participants During the 10-Week Period With Treatment-Emergent (New or Worsening) Suicidal Ideation as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)|"The C-SSRS captured occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal ideation: a yes answer to any 1 of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Results reported as percentage of participants with treatment-emergent (new or worsening) suicidal ideation from baseline=(number of participants with changes compared to baseline/total number of participants at risk)*100."|Baseline up to 10 weeks|Randomized participants with a baseline and at least 1 post-baseline C-SSRS suicidal ideation score during the acute treatment period, whose baseline maximum C-SSRS suicidal ideation score was <5. Nine (9) participants from 1 site with major quality issues were excluded.||percentage of participants|||Number
829365|NCT01226511|Secondary|Change From Baseline to 10-Week Endpoint in the Children's Global Assessment Scale (CGAS)|The CGAS was a clinician-rated assessment of general functioning. CGAS raw scores ranged from 1 (greatest impairment) to 100 (superior functioning). Lower scores indicated a lower level of functioning and greater impairment. Least squares (LS) mean from an analysis of covariance (ANCOVA) was adjusted for treatment, pooled investigator, baseline, and age category.|Baseline, 10 weeks|Randomized participants with a baseline and at least 1 post-baseline [last observation carried forward (LOCF)] CGAS score during the acute treatment period, excluding 9 participants from 1 site with major quality issues.||units on a scale||Standard Error|Least Squares Mean
829366|NCT01226511|Secondary|Remission Rate at Endpoint for Generalized Anxiety Disorder (GAD) Using Clinical Global Impressions of Severity (CGI-S) Scale|Remission rate was defined as the percentage of participants having a CGI-S score ≤2 at endpoint. The CGI-S scale evaluated the severity of illness at the time of assessment. Scores ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill). Higher scores indicated a greater severity of illness.|10 weeks|Randomized participants with at least 1 post-baseline CGI-S score [last observation carried forward (LOCF)] during the acute treatment period, excluding 9 participants from 1 site with major quality issues.||percentage of participants|||Number
829367|NCT01226511|Secondary|Change From Baseline to 10-Week Endpoint on the Clinical Global Impression of Severity (CGI-S) Scale|The CGI-S scale evaluated the severity of illness at the time of assessment. Scores ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill). Higher scores indicated a greater severity of illness. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach adjusted for treatment, pooled investigator, visit, baseline, age category, treatment*visit, baseline*visit, and age category*visit.|Baseline, 10 weeks|Randomized participants with a baseline and at least 1 post-baseline CGI-S score during the acute treatment period, excluding 9 participants from 1 site with major quality issues.||units on a scale||Standard Error|Least Squares Mean
829368|NCT01226511|Secondary|Change From Baseline to 10-Week Endpoint on the Pediatric Anxiety Rating Scale (PARS) Severity Total Score Evaluated for All Symptoms Identified on the PARS Symptom Checklist Symptoms|PARS severity total score was assessed for all symptoms identified on the PARS symptom checklist. PARS severity total score was derived by summing 5 of 7 severity/impairment/interference items (2, 3, 5, 6, 7); each item ranged from 0 (none) to 5 (extreme severity/impairment/interference). PARS severity total scores ranged from 0 (none) to 25 (extreme severity), with a score of 15 indicating moderate illness severity. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach adjusted for treatment, pooled investigator, visit, baseline, age category, treatment*visit, baseline*visit, and age category*visit.|Baseline, 10 weeks|Randomized participants with a baseline and at least 1 post-baseline PARS severity total score during the acute treatment period, excluding 9 participants from 1 site with major quality issues.||units on a scale||Standard Error|Least Squares Mean
829369|NCT01226511|Secondary|Response Rate at Endpoint for Generalized Anxiety Disorder (GAD) Using Pediatric Anxiety Rating Scale (PARS) Severity Score for GAD|Response rate was defined as the percentage of participants having a 50% improvement from baseline to endpoint on the PARS severity score for GAD. PARS severity score for GAD was assessed for all symptoms identified in the generalized anxiety section of the PARS symptom checklist. PARS severity score for GAD was derived by summing 5 of 7 severity/impairment/interference items (2, 3, 5, 6, 7); each item ranged from 0 (none) to 5 (extreme severity/impairment/interference). PARS severity scores for GAD ranged from 0 (none) to 25 (extreme severity), with a score of 15 indicating moderate illness severity.|Baseline, 10 weeks|Randomized participants with a baseline and at least 1 post-baseline PARS severity score for GAD [last observation carried forward (LOCF)] during the acute treatment period, excluding 9 participants from 1 site with major quality issues.||percentage of participants|||Number
829370|NCT01226511|Primary|Change From Baseline to 10-Week Endpoint in the Pediatric Anxiety Rating Scale (PARS) Severity Score Evaluated for Symptoms Identified on the Generalized Anxiety Subsection of the PARS Symptom Checklist|PARS severity score for GAD was assessed for all symptoms identified in the generalized anxiety section of the PARS symptom checklist. PARS severity score for GAD was derived by summing 5 of 7 severity/impairment/interference items (2, 3, 5, 6, 7); each item ranged from 0 (none) to 5 (extreme severity/impairment/interference). PARS severity scores for GAD ranged from 0 (none) to 25 (extreme severity), with a score of 15 indicating moderate illness severity. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach adjusted for baseline, pooled investigator, age category, visit, treatment, treatment*visit, age category*visit, and baseline*visit.|Baseline, 10 weeks|Randomized participants with a baseline and at least 1 post-baseline PARS severity score for GAD during the acute treatment period, excluding 9 participants from 1 site with major quality issues.||units on a scale||Standard Error|Least Squares Mean
829376|NCT01226706|Secondary|Change in Indevus Urgency Severity Scale From Baseline to 6 Months|"A disease specific quality of life measure. A self reported measure that assesses urinary urgency severity associated with overactive bladder.
Indevus Urgency Severity Scale (IIUS) The IIUS is a single item scale designed to describe urinary urges. The scale is rated through the patient’s urge: none (0 points), mild (1), moderate (2) and severe (3). A higher score represents more urinary urges."|Baseline to 6 months|||summary score||Standard Deviation|Mean
829377|NCT01226706|Secondary|Change in Indevus Urgency Severity Scale From Baseline to 3 Months|"A disease specific quality of life measure. A self reported measure that assesses urinary urgency severity associated with overactive bladder.
Indevus Urgency Severity Scale (IIUS) The IIUS is a single item scale designed to describe urinary urges. The scale is rated through the patient’s urge: none (0 points), mild (1), moderate (2) and severe (3). A higher score represents more urinary urges."|Baseline to 3 months|||summary score||Standard Deviation|Mean
829378|NCT01226706|Secondary|Change in Indevus Urgency Severity Scale From Baseline to 6 Weeks|"A disease specific quality of life measure. A self reported measure that assesses urinary urgency severity associated with overactive bladder.
Indevus Urgency Severity Scale (IIUS) The IIUS is a single item scale designed to describe urinary urges. The scale is rated through the patient’s urge: none (0 points), mild (1), moderate (2) and severe (3). A higher score represents more urinary urges."|Baseline to 6 weeks|||summary score||Standard Deviation|Mean
829379|NCT01226706|Secondary|Change in Patient Perception of Bladder Condition From Baseline to 6 Months|"Disease specific validated quality of life measures. A single-item global measure for patients with overactive bladder.
Patient Perception of Bladder Condition (PPBC) The PPBC is a single-item, 6-point scale that asks patients to rate their subjective impression of their current bladder problems. It has been shown to have concurrent and discriminant validity as well as responsiveness to treatment. Patients are asked to rate their perceived bladder condition on a 6-point scale ranging from 1 “no problems at all”, 2 some very minor problems. 3 some minor problems, 4(some) moderate problems, 5 severe problems, and 6 “many severe problems”. A higher score indicates a more negative impression of current bladder problems."|Baseline to 6 months|||summary score||Standard Deviation|Mean
829380|NCT01226706|Secondary|Change in Patient Perception of Bladder Condition From Baseline to 3 Months|"Disease specific validated quality of life measures. A single-item global measure for patients with overactive bladder.
Patient Perception of Bladder Condition (PPBC) The PPBC is a single-item, 6-point scale that asks patients to rate their subjective impression of their current bladder problems. It has been shown to have concurrent and discriminant validity as well as responsiveness to treatment. Patients are asked to rate their perceived bladder condition on a 6-point scale ranging from 1 “no problems at all”, 2 some very minor problems. 3 some minor problems, 4(some) moderate problems, 5 severe problems, and 6 “many severe problems”. A higher score indicates a more negative impression of current bladder problems."|Baseline to 3 months|||summary score||Standard Deviation|Mean
829381|NCT01226706|Secondary|Change in Patient Perception of Bladder Condition From Baseline to 6 Weeks|"Disease specific validated quality of life measures. A single-item global measure for patients with overactive bladder.
Patient Perception of Bladder Condition (PPBC) The PPBC is a single-item, 6-point scale that asks patients to rate their subjective impression of their current bladder problems. It has been shown to have concurrent and discriminant validity as well as responsiveness to treatment. Patients are asked to rate their perceived bladder condition on a 6-point scale ranging from 1 “no problems at all”, 2 some very minor problems. 3 some minor problems, 4(some) moderate problems, 5 severe problems, and 6 “many severe problems”. A higher score indicates a more negative impression of current bladder problems."|Baseline to 6 weeks|||summary score||Standard Deviation|Mean
829382|NCT01226706|Secondary|Change in Urogenital Distress Inventory From Baseline to 6 Months Follow-up|"Disease specific quality of life measure. Health-related quality of life measures for women with urinary incontinence.
The UDI-6 is a 6-point scale that asks patients to respond to questions rating whether they experience and how much they are bothered by UUI. Item responses are assigned values of 0 for “not at all,” 1 for “slightly,” 2 for “moderately,” and 3 for “greatly.” The average score of items responded to is calculated. Higher scores reflect greater distress associated with symptoms. The average, which ranges from 0 to 3, is multiplied by 33 1/3 to put scores on a scale of 0 to 100."|Baseline to 6 months|||summary score||Standard Deviation|Mean
829383|NCT01226706|Secondary|Change in Urogenital Distress Inventory From Baseline to 3 Months Follow-up|"Disease specific quality of life measure. Health-related quality of life measures for women with urinary incontinence.
The UDI-6 is a 6-point scale that asks patients to respond to questions rating whether they experience and how much they are bothered by UUI. Item responses are assigned values of 0 for “not at all,” 1 for “slightly,” 2 for “moderately,” and 3 for “greatly.” The average score of items responded to is calculated. Higher scores reflect greater distress associated with symptoms. The average, which ranges from 0 to 3, is multiplied by 33 1/3 to put scores on a scale of 0 to 100."|Baseline to 3 months|||summary score||Standard Deviation|Mean
829384|NCT01226706|Secondary|Change in Urogenital Distress Inventory From Baseline to 6 Week Follow-up|"Disease specific quality of life measure. Health-related quality of life measures for women with urinary incontinence.
Urogenital Distress Inventory – 6 (UDI-6) The UDI-6 is a 6-point scale that asks patients to respond to questions rating whether they experience and how much they are bothered by UUI. Item responses are assigned values of 0 for “not at all,” 1 for “slightly,” 2 for “moderately,” and 3 for “greatly.” The average score of items responded to is calculated. Higher scores reflect greater distress associated with symptoms. The average, which ranges from 0 to 3, is multiplied by 33 1/3 to put scores on a scale of 0 to 100."|Baseline to 6 weeks|||summary score||Standard Deviation|Mean
829385|NCT01226706|Secondary|Change in Incontinence Impact Questionnaire From Baseline to 6 Months Follow-up|"Disease specific validated quality of life measure. Health-related quality of life measures for women with urinary incontinence.
Incontinences Impact Questionnaire – 7 (IIQ-7) The IIQ-7 is 7-point scale used to rate a patients’ life and the affect of accidental urine loss on activities, relationships, and feelings. Item responses are assigned values of 0 for “not at all,” 1 for “slightly,” 2 for “moderately,” and 3 for “greatly.” The average score of items responded to is calculated. The average, which ranges from 0 to 3, is multiplied by 33 1/3 to put scores on a scale of 0 to 100."|Baseline to 6 months|||summary score||Standard Deviation|Mean
829386|NCT01226706|Secondary|Change in Incontinence Impact Questionnaire From Baseline to 3 Months Follow-up|"Disease specific validated quality of life measure. Health-related quality of life measures for women with urinary incontinence.
Incontinences Impact Questionnaire – 7 (IIQ-7) The IIQ-7 is 7-point scale used to rate a patients’ life and the affect of accidental urine loss on activities, relationships, and feelings. Item responses are assigned values of 0 for “not at all,” 1 for “slightly,” 2 for “moderately,” and 3 for “greatly.” The average score of items responded to is calculated. The average, which ranges from 0 to 3, is multiplied by 33 1/3 to put scores on a scale of 0 to 100."|Baseline to 3 months|||summary score||Standard Deviation|Mean
829387|NCT01226706|Secondary|Change in Incontinence Impact Questionnaire From Baseline to 6 Weeks Follow-up|"Disease specific validated quality of life measure. Health-related quality of life measures for women with urinary incontinence.
Incontinences Impact Questionnaire – 7 (IIQ-7) The IIQ-7 is 7-point scale used to rate a patients’ life and the affect of accidental urine loss on activities, relationships, and feelings. Item responses are assigned values of 0 for “not at all,” 1 for “slightly,” 2 for “moderately,” and 3 for “greatly.” The average score of items responded to is calculated. The average, which ranges from 0 to 3, is multiplied by 33 1/3 to put scores on a scale of 0 to 100."|Baseline to 6 weeks|||scores on a scale||Standard Deviation|Mean
829388|NCT01226706|Secondary|Subjective Benefit Assessment at 6 Months|"Self assessed description of how well they believed the Botulinum Toxin type A was working.The patients’ subjective assessment of the treatment’s efficacy was obtained verbally using a four-point rating scale. Rating options were:
dry (complete response),
improvement (> 50% reduction in incontinence),
partial response (≤ 50% reduction in incontinence),
no response to treatment."|Baseline to 6 months|||score on a 4-point rating scale||Standard Deviation|Mean
829389|NCT01226706|Secondary|Subjective Benefit Assessment at 3 Months|"Self assessed description of how well they believed the Botulinum Toxin type A was working. The patients’ subjective assessment of the treatment’s efficacy was obtained verbally using a four-point rating scale. Rating options were:
dry (complete response),
improvement (> 50% reduction in incontinence),
partial response (≤ 50% reduction in incontinence),
no response to treatment."|Baseline to 3 months|||score on a 4-point rating scale||Standard Deviation|Mean
829390|NCT01226706|Secondary|Subjective Benefit Assessment at 6 Weeks|"Self assessed description of how well they believed the Botulinum Toxin type A was working. The patients’ subjective assessment of the treatment’s efficacy was obtained verbally using a four-point rating scale. Rating options were:
dry (complete response),
improvement (> 50% reduction in incontinence),
partial response (≤ 50% reduction in incontinence),
no response to treatment."|Baseline to 6 weeks|||score on a 4-point rating scale||Standard Deviation|Mean
829391|NCT01226706|Secondary|Change in Number of Night Voids Between Baseline and 24 Months Follow-up|Frequency of night voiding|Baseline and 24 months|||number of voids||Standard Deviation|Mean
829392|NCT01226706|Secondary|Change in Number of Night Voids Between Baseline and 12 Month Follow-up|Frequency of night voiding|Baseline to 12 months|||number of voids||Standard Deviation|Mean
829393|NCT01226706|Secondary|Change in Number of Night Voids Between Baseline and 9 Month Follow-up|Frequency of night voiding|Baseline and 9 months|||Number of voids||Standard Deviation|Mean
829394|NCT01226706|Secondary|Change in Number of Night Voids Between Baseline and 6 Month Follow-up|Frequency of night voiding|Baseline to 6 months|||number of voids||Standard Deviation|Mean
829395|NCT01226706|Secondary|Change in Number of Night Voids Between Baseline and 3 Month Follow-up|Frequency of night voiding|Baseline to 3 months|||Number of voids||Standard Deviation|Mean
829396|NCT01226706|Secondary|Change in Number of Night Voids Between Baseline and 6 Week Follow-up|Frequency of night voiding|Baseline to 6 weeks|||number of voids||Standard Deviation|Mean
829397|NCT01226706|Secondary|Change in Number of Daytime Voids Between Baseline and 24 Month Follow-up|Frequency of daily urination|Baseline to 24 months|||number of voids||Standard Deviation|Mean
829398|NCT01226706|Secondary|Change in Number of Daytime Voids Between Baseline and 12 Month Follow-up|Frequency of daily urination|Baseline to 12 months|||number of voids||Standard Deviation|Mean
829399|NCT01226706|Secondary|Change in Number of Daytime Voids Between Baseline and 9 Month Follow-up|Frequency of daily urination|Baseline to 9 months|||number of voids||Standard Deviation|Mean
829400|NCT01226706|Secondary|Change in Number of Daytime Voids Between Baseline and 6 Month Follow-up|Frequency of daily urination|Baseline to 6 months|||number of voids||Standard Deviation|Mean
829401|NCT01226706|Secondary|Change in Number of Daytime Voids Between Baseline and 3 Month Follow-up|Frequency of daily urination|Baseline to 3 month|||number of voids||Standard Deviation|Mean
829402|NCT01226706|Secondary|Change in Number of Daytime Voids Between Baseline and 6 Week Follow-up|Frequency of daily urination|Baseline to 6 weeks|||number of voids||Standard Deviation|Mean
829403|NCT01226706|Secondary|Change in Incontinence Episodes Between Baseline and 24 Months Follow-up|Incontinence- involuntary leakage of urine|Baseline and 24 months|||number of occurences||Standard Deviation|Mean
829404|NCT01226706|Secondary|Change in Incontinence Episodes Between Baseline and 12 Month Follow-up|Incontinence- involuntary leakage of urine|Baseline and 12 months|||number of occurences||Standard Deviation|Mean
829405|NCT01226706|Secondary|Change in Incontinence Episodes Between Baseline and 9 Month Follow-up|Incontinence- involuntary leakage of urine|Baseline to 9 months|||number of occurences||Standard Deviation|Mean
829406|NCT01226706|Secondary|Change in Incontinence Episodes Between Baseline and 6 Month Follow-up|Incontinence- involuntary leakage of urine|Baseline to 6 month|||number of episodes||Standard Deviation|Mean
829407|NCT01226706|Secondary|Change in Incontinence Episodes Between Baseline and 3 Month Follow-up|Incontinence- involuntary leakage of urine|Baseline to 3 month|||number of occurences||Standard Deviation|Mean
829408|NCT01226706|Secondary|Change in Incontinence Episodes Between Baseline and 6 Week Follow-up|Incontinence- involuntary leakage of urine|Baseline to 6 weeks|||number of episodes||Standard Deviation|Mean
829409|NCT01226706|Primary|Change in Maximum Capacity at Cystoscopy Between Baseline and 6 Month Follow-up|"Cystoscopy is a test performed with a cystoscope, a narrow tube with a tiny camera at its tip, inserted into the urethra and bladder to see the inside of the bladder and urethra.
Maximum bladder capacity--the amount of liquid or gas the bladder can hold under anesthesia. Without anesthesia, capacity is limited by either pain or a severe urge to urinate."|Baseline to 6 months|||mL||Standard Deviation|Mean
829412|NCT01226719|Secondary|Progression-free Survival (PFS)|The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|18 months|All patients on study||months||95% Confidence Interval|Median
829413|NCT01226719|Secondary|R0 Resection Rate|To determine the rate of complete (R0) resection for patients treated with this regimen.|18 months|Includes patients who were surgical candidates and underwent surgery on study||percentage of patients with surgery|||Number
829414|NCT01226719|Primary|Overall Response Rate (ORR)|The Percentage of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|18 months|Includes all patients deemed to be evaluable for response who were evaluated for response||percentage of evaluable participants|||Number
829415|NCT01226732|Secondary|Preliminary Efficacy Assessment: Response Rate (RR)|Response Rate (RR) is defined as the total number of patients with Complete Response (CR) or Partial Response (PR) as defined in RECIST v2. CR is defined as the dissappearance of all target lesions, disappearance of all non-target lesions and normalization of tumor markers. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|18 months|Includes all patients evaluable for response (4 patients were not evaluable)||participants|||Number
829416|NCT01226732|Secondary|Safety|To evaluate the drug related toxicities associated with different doses of the drugs used in this regimen.|18 months|||participants|||Number
829417|NCT01226732|Primary|Dose Determination|To determine the maximum tolerated dose (MTD) of AUY922 plus capecitabine in patients with advanced solid tumors.|18 months|||mg/m^2|||Number
829418|NCT01226745|Primary|Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death and TEAEs Leading to Discontinuation|An Adverse Event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A Serious Adverse Event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs were defined as the AEs that occur between first dose of study drug administration and 35 days after the last dose of study drug administration that were absent before treatment or that worsened relative to pretreatment state.|From the first dose of study drug administration up to 35 days after the last dose of study drug administration, assessed up to 5 years|Safety analysis set consisted of all the enrolled subjects.||Subjects|||Number
829419|NCT01226745|Primary|Number of Subjects With Clinically Significant Abnormalities in Dermatological Examination|A whole body examination, paying particular attention to identify precancerous or cancerous lesions was done by a dermatologist and based on the clinical judgment of the dermatologist the abnormalities were categorized as clinically significant or clinically not significant. Early termination visit was recorded when the subject was early terminated from the study during the first 2.5 year period, while early termination 2 visit was recorded when the subject early terminated from the study during the additional 2 year period with delay shall be defined.|Baseline up to end of the treatment, assessed up to Week 255|Safety analysis set consisted of all the enrolled subjects.||Subjects|||Number
829420|NCT01226745|Primary|Number of Subjects With Clinically Significant Abnormal Ophthalmologic Examination|Subjects underwent comprehensive ophthalmic examination (COE) including best corrected visual acuity (Snellen), manifest refractions, pupil examination, ocular motility, nystagmus, confrontation visual fields, Ishihara color plates, Amsler grid, and tonometry as well as a biomicroscopy slit lamp examination of the conjunctiva, cornea, anterior chamber, iris and lens; and a fundoscopic examination (with dilation) of the vitreous, optic nerve, retinal vessels, macula, and peripheral retina. Optical Coherence Tomography (OCT): Thicknesses of the macular retina and retinal nerve fiber layer at the optic nerve head in each eye was assessed by OCT using the fast macular thickness map scan and the fast retinal nerve fiber layer (RNFL) scan features, respectively. The abnormalities of the ophthalmologic examination was judged to be clinically significant or not as per the investigators discretion. The ophthalmologic examination was performed for both right eye (RE) and left eye (LE).|Baseline up to Week 255|Safety analysis set consisted of all the enrolled subjects. Here “n” signifies the number of subjects analyzed for the individual time point in the outcome measure.||Subjects|||Number
829421|NCT01226745|Primary|Number of Subjects With Clinically Significant Abnormal Electrocardiogram (ECG) Measures|The 12-lead ECG was recorded after the subject was in supine position for 5 minutes. ECGs were acquired on digital cardiographs. Abnormal findings were analyzed as clinically significant or not clinically significant as per the discretion of the study investigator.|Baseline up to Week 255|Safety analysis set consisted of all the enrolled subjects.||Subjects|||Number
829422|NCT01226745|Primary|Change From Baseline in Diffusing Capacity of Lung for Carbon Monoxide (DLCO)|DLCO was one of the most clinically valuable tests of lung function. The DLCO measure the ability of the lungs to transfer gas from inhaled air to the red blood cells in pulmonary capillaries. Early termination visit was recorded when the subject was early terminated from the study during the first 2.5 year period, while early termination 2 visit was recorded when the subject was early terminated from the study during the additional 2 year period with delay. The values for the DLCO “% of predicted” was defined as the mean value of 2 test results that were within a 10% variability of each other.|Baseline, Week 40, 52, early termination, Week 152, 200, 255|Safety analysis set consisted of all the enrolled subjects. Here “n” signifies the number of subjects analyzed for the individual time point in the outcome measure.||Percentage of predicted value||Standard Deviation|Mean
829449|NCT01219855|Primary|Mean Percent Change From Baseline in Plasma Intact Parathyroid Hormone (iPTH) to End of Treatment (Per Protocol Population)|Mean percent change from baseline in plasma intact parathyroid hormone (iPTH) from baseline to End of Treatment (EOT) in the Per Protocol population. Subjects in Cohorts 1 and 2 (dose regimens 60/90 and 30 mcg, respectively) were compared to their respective placebo groups.|6 weeks|Per protocol||percentage of change from baseline||Standard Deviation|Mean
829423|NCT01226745|Primary|Change From Baseline in Forced Vital Capacity (FVC)|FVC (% of predicted value) was the volume of air which was forcibly exhaled from the lungs after taking the deepest breath possible. Early termination visit was recorded when the subject was early terminated from the study during the first 2.5 year period, while early termination 2 visit was recorded when the subject early terminated from the study during the additional 2 year period with delay shall be defined.|Baseline, Week 40, 52, 76, 100, 124, 148, early termination, Week 152, 200, early termination 2, Week 255|Safety analysis set consisted of all the enrolled subjects. Here “n” signifies the number of subjects analyzed for the individual time point in the outcome measure||Percentage of predicted value||Standard Deviation|Mean
829424|NCT01226745|Primary|Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Percent (%) Predicted Value)|FEV1 was defined as the maximal volume of air exhaled in the 1st second of a forced expiration from a position of full inspiration. FEV1 was obtained from spirometry, performed before study treatment administration. Early termination visit was recorded when the subject was early terminated from the study during the first 2.5 year period, while early termination 2 visit was recorded when the subject early terminated from the study during the additional 2 year period with delay shall be defined.|Baseline, Week 40, 52, 76, 100, 124, 148, early termination, Week 152, 200, early termination 2, Week 255|Safety analysis set consisted of all the enrolled subjects. Here “n” signifies the number of subjects analyzed for the individual time point in the outcome measure.||Percentage of predicted value||Standard Deviation|Mean
829425|NCT01226745|Secondary|Percent Brain Volume Change (PBVC) From Baseline at the End of Treatment|Brain volume was obtained by magnetic resonance imaging (MRI). Extension study baseline is defined as the measurement most immediately prior to or on the day of the first dose day of extension study. Brain volume changes very little over time. Hence, the PBVC at the end of treatment was calculated by adding up all the PBVC values from the scans performed during the extension treatment period.|Baseline and at end of treatment (Week 255)|FAS included all subjects who provided any post baseline efficacy data. One randomized error subject was summarized in the sequence 0.15-0.15 as he received 0.15 in core study period and in the sequence Placebo-0.10 mg as he received 0.10 in the extension study period.||Percent brain volume||Standard Deviation|Mean
829426|NCT01226745|Secondary|Change From Baseline in Lesion Volume at the End of the Treatment (EoT)|Brain lesion volume was obtained by magnetic resonance imaging (MRI). Extension study baseline was defined as the measurement most immediately prior to or on the day of the first dose day of extension study. End of treatment (EOT) was defined as the last visit during the treatment period. Change from extension baseline to EOT = last treatment period value in extension study — extension baseline value.|Baseline, End of treatment (5 years)|FAS included all subjects who provided any post baseline efficacy data.One randomized error subject was summarized in the sequence 0.15-0.15 as he received 0.15 in core study period and in the sequence Placebo-0.10 mg as he received 0.10 in the extension study period.||Cubic centimeter (cc)||Standard Deviation|Mean
829427|NCT01226745|Secondary|Number of Gadolinium (Gd)-Enhanced Lesions|Gd-enhanced lesions were obtained by magnetic resonance imaging (MRI) at each scheduled assessment visit over the study period. Extension study baseline is defined as the measurement most immediately prior to or on the day of the first dose day of extension study. End of treatment (EoT) lesion count is the average number of lesion counts per scan, calculated by dividing the sum of all lesion counts by number of scans during the extension treatment period. Early termination visit was recorded when the subject was early terminated from the study during the first 2.5 year period, while early termination 2 visit was recorded when the subject early terminated from the study during the additional 2 year period with delay. Extension study baseline is defined as the measurement most immediately prior to or on the day of the first dose day of extension study.Full Analysis Set (FAS) included all subjects who provided any post baseline efficacy data.|Baseline, Week 40, 52, 100, 148, early termination, Week 152, 200, early termination 2, Week 255 and end of treatment (5 years)|"FAS. n” signifies the number of subjects analyzed for individual time point in the outcome measure.One randomized error subject was summarized in the sequence 0.15-0.15 as he received 0.15 in core study period and in the sequence Placebo-0.10 mg as he received 0.10 in the extension study period."||Lesions||Standard Deviation|Mean
829428|NCT01226745|Primary|Number of Subjects With Clinically Significant Abnormal Vital Signs|Vital signs included oral temperature, pulse, respiration rate and blood pressure (BP) (taken after 5 minutes in the sitting position). The abnormalities in vital signs were decided as clinically significant or not based on the clinical judgment of the investigator.|Baseline up to Week 255|Safety analysis set consisted of all the enrolled subjects.||Subjects|||Number
829429|NCT01227005|Secondary|30-day Mortality|Evaluate 30-day mortality among those receiving whole blood compared to those receiving component therapy|first 30 days after ED admission|||participants|||Number
829430|NCT01227005|Secondary|24-hour Mortality|Mortality rate at 24 hours after arrival|First 24 hours after ED admission|||participants|||Number
829431|NCT01227005|Primary|In a Prospective, Randomized Trial, Evaluate Transfusion of Stored Whole Blood and Pooled Platelets During Transfusion Therapy.|Compare the ability of whole blood to reduce initial 24-hour transfusion requirements as compared to component therapy (red blood cells, plasma, and platelet units)|first 24 hours after ED admission|||units of blood||Inter-Quartile Range|Median
829432|NCT01227018|Other Pre-specified|Biomarker Evaluation|Serum will be tested for biomarkers that may be predictive of response, optional per patient consent.|Pre-treatment and 1 week post-treatment|The study's interim analysis found the study drug to be ineffective. The study was terminated. No biomarkers were performed or analyzed.|||||
829433|NCT01227018|Secondary|Number of Patients With Each Worst Grade Toxicity|Count of patients according to the worst‐grade toxicity experienced by each, where worst‐grade toxicity is per NCI common toxicity criteria: grade 1, mild; grade 2, moderate; grade 3, severe; grade 4, life‐threatening; grade 5, death|On study date to 30 days following final dose of study drug|Total number of patients reported with any toxicity related to study treatment. One patient withdrew before treatment. One patient did not have a toxicity related to study drug or therapy.||participants|||Number
829434|NCT01227018|Secondary|Overall Survival|Estimated probable duration of life from on‐study date to date of death from any cause, using the Kaplan‐Meier method with censoring (see analysis population description for additional details)|study entry to date of death or last date known alive (assessed over 2.5 yrs)|All patients are included in the analysis on intention‐totreat basis. Analysis is by Kaplan‐Meier method, where death is an event, with censoring for non‐expired patients at greater of off‐study date or last known alive date.||days||95% Confidence Interval|Median
829435|NCT01227018|Secondary|Best Response|Number of patients in each response category, per RECIST v1.1, summarized as follows for target lesion criteria (see RECIST v1.1 for additional details): complete response (CR),disappearance of target lesions; partial response (PR), >=30% decrease in sum of longest diameter of target lesions; progressive disease (PD), >=20% increase in sum of LD of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or SD. Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR>PR>SD>PD.|On-treatment date, to date of disease progression (assessed up to 1 year)|All patients with best overall response data; patients are excluded if best overall response data is missing or if the patient is non‐evaluable for best overall response.||participants|||Number
829436|NCT01227018|Primary|Disease Control Rate|Per RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions, and progressive disease (PD) > 20% increase in the sum of the LD of target lesions or appearance of new lesions. Disease control is defined as CR + PR + SD after 8 weeks of therapy.|at 8 weeks from the start of therapy|Patients who received treatment and who were available for determination of response.||percentage of participants|||Number
829437|NCT01227057|Secondary|Executive Functioning as Measured by the Delis Kaplan Executive Functioning System (D-KEFS) at 6 Months|The D-KEFS Trail Making Test Condition 4: Number-Letter Switching Scaled Score was used to assess executive functioning. Scaled scores range from 1-19. Higher scores represent less impairment.|6 months|||units on a scale||Standard Deviation|Mean
829438|NCT01227057|Secondary|Change in Functional Impairment as Measured by the Activities of Daily Living, Functional Disability Index, Clutter Image Rating Scale||5 years||||||
829439|NCT01227057|Primary|Hoarding Symptom Severity as Measured by the Saving Inventory-Revised (SI-R) at 6 Months|Hoarding symptom severity (primary outcome) will be measured using the Savings Inventory-Revised (SI-R), a 23-item self-report measure used to assess common hoarding symptoms. Subtests include excessive clutter, compulsive acquisition, and difficulty discarding. The SI-R has demonstrated good internal consistency, divergent validity, concurrent validity, divergent validity, test-retest reliability in clinical samples with hoarding. The total score will be used for analyses. The range of the total score is 0-92, with higher scores indicating worse hoarding severity.|6 months|||units on a scale||Standard Deviation|Mean
829440|NCT01219673|Primary|Treatment Effects on 5 Selected Symptoms (Average MDASI-HNC Scores)|Treatments ability to reduce values of 5 symptoms comprised of MD Anderson Symptom Inventory (MDASI)-Head and Neck Cancer (HNC) scores for fatigue, difficulty swallowing, sleep disturbance, pain, and lack of appetite collected during the 10 weeks of chemoradiation treatment. symptoms that are caused by their disease or by their treatment. Symptom severity score is comprised of average of the five above MDASI core items (fatigue, difficulty swallowing, sleep disturbance, pain, and lack of appetite). Participants were asked to rate severity of each symptom at their worst in last 24 hours; each item rated from 0 to 10, with 0 = symptom not present and 10 = as bad as you can imagine. Total average score range: 0 to 10. Lower scores indicated better outcome.|10 weeks|No analysis was completed. Study terminated with low enrollment.|||||
829441|NCT01219738|Secondary|Forced Expiratory Volume in 1 Second (FEV1)|FEV1 will be measured before and up to 6 hours after a single inhaled dose of 360ug, 720ug, and 1440ug budesonide or placebo from a DPI, using a double-blinded randomized design on different days.|participant will be followed up to 6 hours after budesonide dose|||percentage of change from baseline||Standard Error|Mean
829442|NCT01219738|Primary|Airway Blood Flow (Qaw)|Qaw will be measured before and up to 6 hours after a single inhaled dose of 360ug, 720ug, and 1440ug budesonide or placebo from a DPI, using a double-blinded randomized design on different days.|participants will be followed for 6 hours after budesonide dose|||percentage of change from baseline||Standard Error|Mean
829443|NCT01219777|Secondary|Toxicity and Response Rates Based on Imaging and Surgical Outcomes|Determine the safety/toxicity of this regimen in this patient population. Estimate the percent of patients undergoing successful cytoreductive surgery to optimal disease (<1 cm greatest tumor diameter) following neoadjuvant chemotherapy with carboplatin, paclitaxel and bevacizumab in patients with epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer. Assess the 30 day morbidity and mortality following surgical intervention. To describe the response rate for patients treated with neoadjuvant carboplatin, weekly paclitaxel, and bevacizumab using RECIST and GCIG response criteria prior to surgical intervention. Response was determined per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 6 months|||patients|||Number
829444|NCT01219777|Primary|Tolerated Dose|To determine the maximum tolerated dose of carboplatin AUC5 administered Day 1 Cycles 1-4, weekly paclitaxel 60-80mg/m2 administered on Day 1, 8,and 15 for 3 weeks cycles 1-4, bevacizumab 15mg/kg administered Day 1 Cycles 1-3 prior to surgical intervention.|Up to 6 months|||mg/m^2|||Number
829445|NCT01219855|Secondary|Proportion of Subjects With Reduction of Intact Parathyroid Hormone (iPTH) of at Least 20% at Week 6|Proportion of subjects with at least 20% reduction in plasma intact parathyroid hormone (iPTH) and/or mean iPTH reduction to 70 pg/mL or less at End of Treatment (EOT)|Baseline to End of Treatment (6 weeks)|Per protocol population||participants|||Number
829446|NCT01219855|Secondary|Proportion of Subjects With Reduction of Intact Parathyroid Hormone (iPTH) of at Least 30% at Week 6|Proportion of subjects with at least 30% reduction in plasma intact parathyroid hormone (iPTH) and/or mean iPTH reduction to 70 pg/mL or less at End of Treatment (EOT)|Baseline to End of Treatment (6 weeks)|Per protocol||participants|||Number
829447|NCT01219855|Secondary|Percent Change From Baseline in Serum 25-hydroxyvitamin D at End of Treatment (EOT, Week 6) in the Per Protocol Population|Mean percent change from baseline in serum 25-hydroxyvitamin D at End of Treatment (EOT, week 6) in the per protocol population. Subjects in Cohorts 1 and 2 (dose regimens of 60/90 and 30 mcg, respectively) were compared versus their corresponding placebo groups.|Baseline to End of Treatment (6 weeks)|Per protocol population||percentage of change from baseline||Standard Deviation|Mean
829448|NCT01219855|Secondary|Change From Baseline in Serum 25-hydroxyvitamin D at Week 6|Mean absolute change from baseline in serum total 25-hydroxyvitamin D to end of treatment (EOT)|Baseline to End of Treatment (6 weeks)|Per protocol population||ng/mL||Standard Deviation|Mean
829450|NCT01219855|Primary|Proportion (%) of Subjects With Serum 25-hydroxyvitamin D ≥30 ng/mL (PP).|The proportion of subjects in the per protocol population with serum 25-hydroxyvitamin D ≥30 ng/mL at End-of-Treatment (EOT; Week 6) in Cohorts 1 and 2 (60/90 and 30 μg groups, respectively) were compared to their corresponding placebo groups.|6 weeks|Per protocol||percentage of participants|||Number
829451|NCT01219881|Secondary|Severity of Coughing|Effect of desflurane versus sevoflurane on the incidence and severity of coughing using a standardized coughing scale|14 days|Determined if patient passed eligibility and completed study.||Patients with a coughing episode|||Number
829452|NCT01219881|Secondary|Time to Extubation|Time from gas discontinuation to eye extubation after eye opening|14 days|Determined if patient passed eligibility and completed study.||Minutes||Standard Deviation|Mean
829453|NCT01219881|Secondary|Difference in Time to Orientation|Difference in time to orientation as measured by SOMCT between the desflurane group and the sevoflurane group|14 Days|Determined if patient passed eligibility and completed study.||Minutes||Inter-Quartile Range|Median
829454|NCT01219881|Primary|Recovery Time|Recovery Time after exposure to desflurane or sevoflurane using a standardized wake up|14 Days|Determined if patients passed all eligibility and completed study.||Minutes||Inter-Quartile Range|Median
829455|NCT01219933|Secondary|Percentage of Participants With LDA or Remission During the Interventional Phase Assessed Using DAS28-CRP|DAS28 calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joint count, the CRP and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28-CRP ≤3.2 and oral GC intake with MP equivalent dose of ≥1 mg and ≤20 mg/day=LDA; DAS28 <2.6 = remission.|Visits 3 (7 months), 4 (8 months), 5 (9 months), 6 (10 months), 7 (11 months), 8 (12 months), 9 (24 weeks after V3) or CV (4 weeks after GC-free status, maximum of 24 weeks after V3)|Safety Int run-in; n=number of participants analyzed for the given parameter at the specified timepoint.||percentage of participants|||Number
829456|NCT01219933|Secondary|Percentage of Participants With LDA or Remission During the Interventional Phase Assessed Using CDAI|The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-100 mm VAS; higher scores=greater affection due to disease activity. CDAI total score=0-76. CDAI ≤2.8=disease remission and >2.8 to 10=LDA.|Visits 3 (7 months), 4 (8 months), 5 (9 months), 6 (10 months), 7 (11 months), 8 (12 months), and 9 (24 weeks after V3) or CV (4 weeks after GC-free status, maximum of 24 weeks after V3)|Safety Int run-in; n=number of participants analyzed for the given parameter at the specified timepoint.||percentage of participants|||Number
829457|NCT01219933|Secondary|CDAI Score During the Interventional Phase|The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-100 mm VAS; higher scores=greater affection due to disease activity. CDAI total score=0-76. CDAI ≤2.8=disease remission, >2.8 to 10=LDA, >10 to 22=moderate disease activity, and >22=high disease activity. V3, CV, and the change from V3 to CV was determined.|V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)|Safety Int run-in; n=number of participants analyzed for the given parameter at the specified timepoint.||units on a scale||Standard Deviation|Mean
829458|NCT01219933|Secondary|SF-36 Subscale Scores During the Interventional Phase|SF-36 is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical and mental component scores (PCS and MCS). Total of 11 variables were analyzed (8 subscales, 2 composite subscales and Question 2 “how would you rate your health in general now?” (range 1= better, 5= worst). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Higher scores reflect higher quality of life. V3, CV, and the change from V3 to CV was determined.|V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)|ITT Population; n=number of participants analyzed for the given parameter at the specified time point.||units on a scale||Standard Deviation|Mean
829459|NCT01219933|Secondary|Short-Form 36 (SF-36) Mental Component Score (MCS) and Physical Component Score (PCS) During the Interventional Phase|36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical and mental component scores (PCS and MCS). Total of 11 variables were analyzed (8 subscales, 2 composite subscales and Question 2 “how would you rate your health in general now?” (range 1= better, 5= worst). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Higher scores reflect higher quality of life. V3, CV, and the change from V3 to CV was determined.|V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)|Safety Int run-in; n=number of participants analyzed for the given parameter at the specified timepoint.||units on a scale||Standard Deviation|Mean
829460|NCT01219933|Primary|Percentage of Participants in the Interventional Phase Who Achieved LDA and Discontinued Oral GC Within 20 Weeks|The percentage of participants with rheumatoid arthritis (RA) with LDA was defined as DAS28 ≤3.2, able to discontinue oral GC within 20 weeks and at the latest at V8, confirmed at the Consolidation Visit without loss of clinical response defined as DAS28 (CRP) >3.2.|Visits 3 (7 months), 4 (8 months), 5 (9 months), 6 (10 months), 7 (11 months), and 8 (12 months)|Intent-to-Treat (ITT) population: all participants included in the interventional GC reduction phase of the study.||percentage of participants||95% Confidence Interval|Number
829461|NCT01219933|Primary|Type of GC Taken at the End of the Noninterventional Phase|During the noninterventional phase of the study participants received GC as prescribed by the physician.|V1 and V2 (up to 6 months after V1)|Safety obs population; n=number of participants analyzed for a given parameter at a specified timepoint||percentage of participants|||Number
829476|NCT01219933|Secondary|Clinical Disease Activity Index (CDAI) During the Noninterventional Phase|The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and Physician Global Assessment (PGA) of disease assessed on 0-100 mm Visual analog scale (VAS); higher scores=greater affection due to disease activity. CDAI total score=0-76. CDAI ≤2.8=disease remission, >2.8 to 10=LDA, >10 to 22=moderate disease activity, and >22=high disease activity.|V1 and V2 (up to 6 months after V1)|Safety Obs Population; n=number of participants analyzed for the given parameter at the specified timepoint.||units on a scale||Standard Deviation|Mean
829462|NCT01219933|Secondary|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score During the Interventional Phase|FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). The larger the participant’s response to the questions (with the exception of 2 negatively stated), the greater the participant’s fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant’s response). The sum of all responses resulted in the FACIT-F score for a total possible score of 0 (worse score) to 52 (better score). V3, CV, and the change from V3 to CV was determined.|V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)|Safety Int run-in; n=number of participants analyzed for the given parameter at the specified timepoint.||units on a scale||Standard Deviation|Mean
829463|NCT01219933|Secondary|SJC and TJC During the Interventional Phase|TJC and SJC were assessed for 28 joints. An assessment of 28 joints for swelling and tenderness was made. Joints were assessed and classified as swollen (1)/not swollen (0) and tender (1)/not tender (0) by pressure and joint manipulation on physical examination for a total score range of 0-28. Higher scores indicated greater disease activity (tenderness/swelling). V3, CV, and the change from V3 to CV was determined.|V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)|Safety Int run-in; n=number of participants analyzed for the given parameter at the specified timepoint.||joints||Standard Deviation|Mean
829464|NCT01219933|Secondary|VAS for Pain (VAS-Pain) During the Interventional Phase|Participants were asked to mark the line corresponding to the intensity of their pain on a 100-mm VAS, where 0=no pain and 100=worst possible pain. The distance from the left edge was measured. Change = V3 mean minus CV mean.|V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)|Safety Int run-in; n=number of participants analyzed for the given parameter at the specified timepoint. Only participants with values at both visits were included in the analysis.||mm||Standard Deviation|Mean
829465|NCT01219933|Secondary|VAS-Physician's Global Assessment of Disease Activity (GDA) During the Interventional Phase|Physician's were asked to determine the overall GDA for each participant using a 100-mm VAS, where 0=no disease activity and 100=maximum disease activity. The physician marked the line corresponding to their assessment and the distance from the left edge was measured. V3, CV, and the change from V3 to CV was determined.|V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)|Safety Int run-in; n=number of participants analyzed for the given parameter at the specified timepoint. Only participants with values at both visits were included in the analysis.||mm||Standard Deviation|Mean
829466|NCT01219933|Secondary|HAQ-DI During the Interventional Phase|HAQ-DI is a self-reported, valid assessment of functional disability in RA. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ-DI score range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation. V3, CV, and the change from V3 to CV was determined.|Visit 3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)|Safety Obs Population; n=number of participants analyzed for the given parameter at the specified timepoint.||units on a scale||Standard Deviation|Mean
829467|NCT01219933|Secondary|DAS28-CRP During the Interventional Phase|DAS28-CRP was calculated from the SJC and TJC using the 28-joint count and CRP (mg/L). Total score range: 0 to 10, higher score indicated more disease activity. DAS28-CRP) ≤3.2=LDA and >3.2 to 5.1=moderate to high disease activity, and DAS28-CRP <2.6=remission. DAS28-CRP values indicated in the CRF were recalculated by the data manager. The cumulative DAS28 (CRP) value (AUC method) was performed using the calculated DAS28. The recalculated values were used in the statistical analyses.|V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)|Safety Obs Population; n=number of participants analyzed for the given parameter at the specified timepoint.||units on a scale||Standard Deviation|Mean
829468|NCT01219933|Secondary|Time-Averaged GC Dose Changes During the Interventional Phase|"Area Under the Curve (AUC) of GC dose during the interventional phase was determined using the trapezoidal method and was calculated as:
AUC = sigma(Ti+1 - Ti) x [(Di+1+Di)/2]
With Di=dosage at time Ti
It corresponds to the total GC dose received between Baseline (visit 3) and visit 9 and has been calculated only for the 30 patients achieving visit 9."|V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)|Safety Int run-in; only participants who completed the study were included in the analysis.||mg||Standard Deviation|Mean
829469|NCT01219933|Secondary|Percentage of Participants Able to Discontinue GCs During the Interventional Phase by V9||V9 (24 weeks after V3)|Safety Int run-in; pnly those participants who completed the study at V9 were included in analysis.||percentage of participants||95% Confidence Interval|Number
829470|NCT01219933|Secondary|Percentage of Participants Able to Reduce Oral GCs by ≥50 Percent (%) During the Interventional Phase by V9||V9 (24 weeks after V3)|Safety Int run-in; only those participants who completed the study at V9 were included in the analysis.||percentage of participants||95% Confidence Interval|Number
829471|NCT01219933|Secondary|Percentage of Participants Able to Start the GC Reduction Phase at V3|All participants who maintained LDA (defined as DAS28-CRP ≤3.2) from V2 to V3 were included in the interventional phase for reduction of GC.|V3 (7 months)|Safety Int (intervention) run-in: all participants eligible to enter the interventional phase at V2 and who had taken at least 1 dose of MP.||percentage of participants||95% Confidence Interval|Number
829472|NCT01219933|Secondary|Percentage of Participants With Changes in RA Treatment During the Noninterventional Phase||V1 and V2 (up to 6 months after V1)|Safety Obs Population||percentage of participants|||Number
829473|NCT01219933|Secondary|Number of Participants With Changes in Tocilizumab Dose During the Noninterventional Phase|The dose of tocilizumab could have been reduced from the recommended 8 mg/kg to 4 mg/kg in participants in the case of adverse events.|V1 and V2 (up to 6 months after V1)|Safety Obs Population||participants|||Number
829474|NCT01219933|Secondary|Median Dose of Tocilizumab During the Noninterventional Phase||V1 and V2 (up to 6 months after V1)|Safety Obs Population||mg/kg||Full Range|Median
829475|NCT01219933|Secondary|Median Time Interval Between V1 and V2|The noninterventional phase was planned to last for a maximum of 6 months per participant. The time between V1 and V2 was measured in months.|V1 and V2 (up to 6 months after V1)|Safety Obs Population||months||Full Range|Median
829477|NCT01219933|Secondary|DAS28-ESR During the Noninterventional Phase|DAS28-ESR was calculated from the SJC and TJC using the 28 joints count and ESR (millimeters per hour [mm/hr]). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-ESR ≤3.2=LDA and >3.2 to 5.1=moderate to high disease activity, and DAS28-ESR <2.6=remission. Timepoint was V2, or before V2 for participants withdrawn before V2; DAS28-ESR values indicated in the CRF were recalculated by the data manager. The recalculated values were used in the statistical analyses.|V1 and V2 (up to 6 months after V1)|Safety Obs Population; n=number of participants analyzed for the given parameter at the specified timepoint.||units on a scale||Standard Deviation|Mean
829478|NCT01219933|Secondary|DAS28-CRP During the Noninterventional Phase|DAS28-CRP was calculated from the swollen joint count (SJC) and tender joint count (TJC) using the 28-joint count and CRP (mg/L). Total score range: 0 to 10, higher score indicated more disease activity. DAS28-CRP ≤3.2=LDA and >3.2 to 5.1=moderate to high disease activity, and DAS28-CRP <2.6=remission. Timepoint was V2, or before V2 for participants withdrawn before V2; DAS28-CRP values indicated in the Case Report Form (CRF) were recalculated by the data manager. The recalculated values were used in the statistical analyses.|V1 and V2 (up to 6 months after V1)|Safety Obs Population; n=number of participants analyzed for the given parameter at the specified timepoint.||units on a scale||Standard Deviation|Mean
829479|NCT01219933|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI) During the Noninterventional Phase|HAQ-DI is a self-reported, valid assessment of functional disability in RA. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ-DI score range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation. Timepoint was V2, or before V2 for participants withdrawn before V2.|V1 and V2 (up to 6 months after V1)|Safety Obs Population; n=number of participants analyzed for the given parameter at the specified timepoint.||units on a scale||Standard Deviation|Mean
829480|NCT01219933|Secondary|Percentage of Participants Positive for Anti-cyclic Citrullinated Peptide (Anti-CCP) Antibody During the Noninterventional Phase|Anti-CCP antibodies are important markers of bone erosion in RA. Anti-CCP antibodies were classified as positive if >7 U/mL.|V1 and V2 (up to 6 months after V1)|Safety Obs Population; n=number of participants analyzed for the given parameter at the specified timepoint.||percentage of participants|||Number
829481|NCT01219933|Secondary|Percentage of Participants Positive for Rheumatoid Factor (RF) During the Noninterventional Phase|RF is the auto antibody directed against immunoglobulin G (IgG) and its concentration is observed in human serum or plasma. RF value higher than 20 units per milliliter (U/mL) is considered positive.|V1 and V2 (up to 6 months after V1)|Safety Obs Population; n=number of participants analyzed for the given parameter at the specified timepoint.||percentage of participants|||Number
829482|NCT01219933|Secondary|Number of Erosions During the NonInterventional Phase|In RA, the presence, number, and size of bone erosions and the number of joints with erosions on CRs are hallmarks for diagnosis, staging and prediction of damage progression and are used for treatment monitoring in randomized controlled studies.|V1 and V2 (up to 6 months after V1)|Safety Obs Population; n=number of participants analyzed for the given parameter at the specified timepoint.||erosions||Standard Deviation|Mean
829483|NCT01219933|Secondary|Percentage of Participants With Erosions During the NonInterventional Phase|In RA, the presence, number and size of bone erosions and the number of joints with erosions on conventional radiographs (CRs) are hallmarks for diagnosis, staging and prediction of damage progression and are used for treatment monitoring in randomized controlled studies.|V1 and V2 (up to 6 months after V1)|Safety Obs Population; n=number of participants analyzed for the given parameter at the specified timepoint.||percentage of participants|||Number
829484|NCT01219933|Secondary|Percentage of Participants Acheiving Remission Assessed Using DAS28 While Receiving Oral GC on Background TocilizumabTreatment During the Noninterventional Phase|DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the CRP and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <2.6 = remission.|V1 and V2 (up to 6 months after V1)|Safety Obs population||percentage of participants|||Number
829485|NCT01219933|Secondary|Percentage of Participants Able to Acheive LDA Assessed Using DAS28 While Receiving Oral GC on Background Tocilizumab Treatment During the Noninterventional Phase|DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the CRP and Patient's Global Assessment (PtGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2 and oral GC intake with MP equivalent dose of ≥1 mg and ≤20 mg/day= LDA.|V1 and V2 (up to 6 months after V1)|Safety Obs Population||percentage of participants|||Number
829486|NCT01219933|Primary|Number of Participants With GC Switches During the Noninterventional Phase|During the noninterventional phase of the study, once LDA was achieved, GC was switched to MP tablets.|V1 and V2 (up to 6 months after V1)|Safety obs population; n=number of participants analyzed for a given parameter at a specified timepoint||participants|||Number
829487|NCT01219933|Primary|Median GC Dose Taken During the Noninterventional Phase|During the noninterventional phase of the study participants received GC as prescribed by the physician. Doses of all GC administered are expressed as MP equivalents.|V1 and V2 (up to 6 months after V1)|Safety obs population; n (number) equals (=) number of participants analyzed for a given parameter at a specified timepoint||mg||Full Range|Median
829488|NCT01219985|Secondary|Lesions Uptake Measurement (SUVmax)|For each detected uptake (in Ungated or CT-based PET images), observers have to report the corresponding maximum standardized uptake value (SUVmax). The SUVmax was obtained automatically in a volume of interest encompassing the entire lesion.|Day 1|The number of participant has been determined on the basis of the annual possible recruitment in the institution to keep the study feasible.||g/L||Standard Deviation|Mean
829489|NCT01219985|Primary|Number of Detected Uptakes on PET Images|Observers have to analyse Ungated and/or CT-based PET images. They have to report, for each uptake they see, the corresponding liver segment (according to Couinaud segmental classification).|day 1|Patients who underwent liver resection||number of real metastatic lesions|||Number
829490|NCT01220128|Primary|Number of Subjects With Breast Cancer Pathological Response|The pathological response in lymph nodes was evaluated by presence or absence of tumor cells by histopathological examination. Partial responses mark the disappearance of tumor cells, with only small clusters or dispersed cells remaining (more than 90% loss) while complete response indicate no identifiable malignant cells. However, ductal carcinoma in situ may be present.|During Phase II of the study period, up to Year 3|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.||Subjects|||Number
829491|NCT01220128|Primary|Number of Subjects With Serious Adverse Events (SAEs), Assessed by the Investigators as Causally Related to GSK2302024A Treatment, by CTCAE Maximum Grade Reported||During the treatment period and up to 30 days post last vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.||Subjects|||Number
829492|NCT01220128|Primary|Number of Subjects With Adverse Events (AEs) Assessed by the Investigators as Causally Related to GSK2302024A Treatment, by CTCAE Maximum Grade Reported||During the treatment period and up to 30 days post last vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.||Subjects|||Number
829493|NCT01220128|Primary|Number of Subjects With Serious Adverse Events (SAEs), by CTCAE Maximum Grade Reported||During the treatment period and up to 30 days post last vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.||Subjects|||Number
829494|NCT01220128|Primary|Number of Subjects With Neutrophil Count Decreased Abnormality, by CTCAE Maximum Grade||During the treatment period and up to 30 days post last vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.||Subjects|||Number
829495|NCT01220128|Primary|Number of Subjects With White Blood Cell Decreased Abnormality, by CTCAE Maximum Grade||During the treatment period and up to 30 days post last vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.||Subjects|||Number
829496|NCT01220128|Primary|Number of Subjects With Platelet Count Decreased Abnormality, by CTCAE Maximum Grade||During the treatment period and up to 30 days post last vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.||Subjects|||Number
829497|NCT01220128|Primary|Number of Patients With Adverse Events (AEs), by CTCAE Maximum Grade Reported||During the treatment period and up to 30 days post last vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.||Subjects|||Number
829498|NCT01220128|Primary|Number of Subjects With Lymphocyte Count Increased Abnormality, by CTCAE Maximum Grade||During the treatment period and up to 30 days post last vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.||Subjects|||Number
829499|NCT01220128|Primary|Number of Subjects With Lymphocyte Count Decreased Abnormality, by CTCAE Maximum Grade||During the treatment period and up to 30 days post last vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.||Subjects|||Number
829500|NCT01220128|Primary|Number of Subjects With Hyponatremia Abnormality, by CTCAE Maximum Grade||During the treatment period and post 30 days post last vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.||Subjects|||Number
829501|NCT01220128|Primary|Number of Subjects With Hypokalemia Abnormality, by CTCAE Maximum Grade||During the treatment period and up to 30 days post last vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.||Subjects|||Number
829502|NCT01220128|Primary|Number of Subjects With Hypocalcemia Abnormality, by CTCAE Maximum Grade||During the treatment period and up to 30 days post last vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.||Subjects|||Number
829503|NCT01220128|Primary|Number of Subjects With Hypoalbuminemia Abnormality, by CTCAE Maximum Grade||During the treatment period and up to 30 days post last vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.||Subjects|||Number
829504|NCT01220128|Primary|Number of Subjects With Hypernatremia Abnormality, by CTCAE Maximum Grade||During the treatment period and up to 30 days post last vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.||Subjects|||Number
829505|NCT01220128|Primary|Number of Subjects With Hyperkalemia Abnormality, by CTCAE Maximum Grade||During the treatment period and up to 30 days post last vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.||Subjects|||Number
829506|NCT01220128|Primary|Number of Subjects With Hypercalcemia Abnormality, by CTCAE Maximum Grade||During the treatment period and up to 30 days post last vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.||Subjects|||Number
829507|NCT01220128|Primary|Number of Subjects With Hemoglobin Increased Abnormality, by CTCAE Maximum Grade||During the treatment period and up to 30 days post last vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.||Subjects|||Number
829508|NCT01220128|Primary|Number of Subjects With Creatine Increased Abnormality, by CTCAE Maximum Grade||During the treatment period and up to 30 days post last vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.||Subjects|||Number
829509|NCT01220128|Primary|Number of Subjects With Blood Bilirubin Increased Abnormality, by CTCAE Maximum Grade||During the treatment period and up to 30 days post last vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.||Subjects|||Number
829510|NCT01220128|Primary|Number of Subjects With Aspartate Aminotransferase Increased Abnormality, by CTCAE Maximum Grade||During the treatment period and up to 30 days post last vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.||Subjects|||Number
829512|NCT01220128|Primary|Number of Subjects With Alkaline Phosphatase Increased Abnormality, by CTCAE Maximum Grade||During the treatment period and up to 30 days post last vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.||Subjects|||Number
829513|NCT01220128|Primary|Number of Subjects With Alanine Aminotransferase Increased Abnormality, by Common Terminology Criteria for Adverse Events (CTCAE) Maximum Grade||During the treatment period and up to 30 days post last vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.||Subjects|||Number
829514|NCT01220128|Primary|Number of Subjects With Serious Adverse Events SAE(s)|A serious adverse event (SAE) is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of hospitalization, causes disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study patient. In this study, an event which was part of the natural course of the disease under study (i.e., disease progression/recurrence) was captured in the study/as an efficacy measure. Therefore it was not reported as an SAE. Progression/recurrence of the tumor was recorded in the clinical assessments in the electronic case report form (eCRF). Death due to progressive disease was recorded on a specific form in the eCRF but not as an SAE.|From Week 0 to Week 26/32|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.||Subjects|||Number
829515|NCT01220128|Primary|Number of Patients With Adverse Events (AEs)|An AE is any untoward medical occurrence in a clinical investigation patient, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse.|During the 31-day (Days 0-30) following vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.||Subjects|||Number
829516|NCT01220128|Primary|Number of Patients With an Anti-Wilm's Tumor Gene (Anti-WT1) Humoral Response|At post-GSK2302024A/placebo Dose 4 (Week 13)|For initially seronegative patients: post-administration antibody concentration ≥ 9 EU/mL For initially seropositive patients: post-administration antibody concentration ≥ 2 fold the pre-vaccination antibody concentration. The main analysis for the Phase|According-to-Protocol (ATP) Population for immunogenicity included all eligible patients who did not report major protocol deviation, who had at least received the first 4 doses of study product and provided a valid result for immunogenicity measurement within the 4 weeks following Dose 4.||Subjects|||Number
829517|NCT01220128|Primary|Number of Subjects With Severe Toxicities|"Severe toxicity was defined as follows:
A Grade 3 or higher toxicity that is related or possibly related to the combined administration of standard treatment and GSK2302024A/placebo
A decrease in Left Ventricular Ejection Fraction (LVEF) from baseline with ≥ 10 points and at < 50% that is related or possibly related to the combined administration of treatment and that is confirmed by a second LVEF assessment within approximately 3 weeks.
A Grade 2 or higher cardiac ischemia/infarction that is related or possibly related to the combined administration of standard treatment and GSK2302024A /placebo.
A Grade 2 or higher allergic reaction occurring within 24 hours following the administration.
A Grade 3 or higher blood/bone marrow toxicity that was considered as related or possibly related to the combined Administration.
A decrease in renal function at the time of administration that was considered as related or possibly related."|During the whole study period, up to Year 3|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.||Subjects|||Number
829518|NCT01220180|Secondary|Number of Participants With PGIC Scale for Fibromyalgia in PP Population|PGIC was defined as participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Change is defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse) , 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected.|Week 6|PP population included participants who received the study medication for at least 6 weeks and indication of use was fibromyalgia.||Participants|||Number
829519|NCT01220180|Secondary|Number of Participants With PGIC Scale for Fibromyalgia in ITT Population|PGIC was defined as participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Change is defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse) , 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected.|Week 6|ITT population included participants who received at least 1 dose of the study medication and indication of use was fibromyalgia.||Participants|||Number
829520|NCT01220180|Secondary|Number of Participants With CGIC Scale for Fibromyalgia in PP Population|CGIC: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Change was defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse), 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected.|Week 6|PP population included participants who received the study medication for at least 6 weeks and indication of use was fibromyalgia.||Participants|||Number
829521|NCT01220180|Secondary|Number of Participants With CGIC Scale for Fibromyalgia in ITT Population|CGIC: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Change was defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse), 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected.|Week 6|ITT population included participants who received at least 1 dose of the study medication and indication of use was fibromyalgia.||Participants|||Number
829522|NCT01220180|Secondary|Number of Participants With PGIC Scale for NeP in PP Population|PGIC was defined as participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Change was defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse) , 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected.|Week 6|PP population included participants who received the study medication for at least 6 weeks and indication of use was NeP.||Participants|||Number
829523|NCT01220180|Secondary|Number of Participants With Patient's Global Impression of Change (PGIC) Scale for NeP in ITT Population|PGIC was defined as participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Change was defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse) , 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected.|Week 6|ITT population included participants who received at least 1 dose of the study medication and indication of use was NeP.||Participants|||Number
829524|NCT01220180|Secondary|Number of Participants With CGIC Scale for NeP in PP Population|CGIC: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Change is defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse), 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected.|Week 6|PP population included participants who received the study medication for at least 6 weeks and indication of use was NeP.||Participants|||Number
829525|NCT01220180|Secondary|Number of Participants With Clinician's Global Impression of Change (CGIC) Scale for NeP in ITT Population|CGIC: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Change is defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse), 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected.|Week 6|ITT population included participants who received at least 1 dose of the study medication and indication of use was NeP.||Participants|||Number
829526|NCT01220180|Secondary|Change From Baseline in Sleep Interference Score for Fibromyalgia in PP Population at Week 6|DSIS: participant rated 11-point Likert scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication.|Baseline and Week 6|PP population included participants who received the study medication for at least 6 weeks and indication of use was fibromyalgia.||Units on a scale||Standard Deviation|Mean
829527|NCT01220180|Secondary|Change From Baseline in Sleep Interference Score for Fibromyalgia in ITT Population at Week 6|DSIS: participant rated 11-point Likert scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication.|Baseline and Week 6|ITT population included participants who received at least 1 dose of the study medication and indication of use was fibromyalgia.||Units on a scale||Standard Deviation|Mean
829528|NCT01220180|Secondary|Change From Baseline in Sleep Interference Score for NeP in PP Population at Week 6|DSIS: participant rated 11-point Likert scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication.|Baseline and Week 6|PP population included participants who received the study medication for at least 6 weeks and indication of use was NeP.||Units on a scale||Standard Deviation|Mean
829529|NCT01220180|Secondary|Change From Baseline in Sleep Interference Score for NeP in ITT Population at Week 6|Daily Sleep Interference Score (DSIS): participant rated 11-point Likert scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication.|Baseline and Week 6|ITT population included participants who received at least 1 dose of the study medication and indication of use was NeP.||Units on a scale||Standard Deviation|Mean
829530|NCT01220180|Primary|Change From Baseline in Daily Pain Score for Fibromyalgia in PP Population at Week 6|DPRS: participant rated 11-point Likert scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain.|Baseline and Week 6|PP population included participants who received the study medication for at least 6 weeks and indication of use was fibromyalgia.||Units on a scale||Standard Deviation|Mean
829531|NCT01220180|Primary|Change From Baseline in Daily Pain Score for Fibromyalgia in ITT Population at Week 6|DPRS: participant rated 11-point Likert scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain.|Baseline and Week 6|ITT population included participants who received at least 1 dose of the study medication and indication of use was fibromyalgia.||Units on a scale||Standard Deviation|Mean
829532|NCT01220180|Primary|Change From Baseline in Daily Pain Score for NeP in PP Population at Week 6|DPRS: participant rated 11-point Likert scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain.|Baseline and Week 6|PP population included participants who received the study medication for at least 6 weeks and indication of use was NeP.||Units on a scale||Standard Deviation|Mean
829533|NCT01220180|Primary|Change From Baseline in Daily Pain Score for NeP in ITT Population at Week 6|Daily Pain Rating Score (DPRS): participant rated 11-point Likert scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain.|Baseline and Week 6|ITT population included participants who received at least 1 dose of the study medication and indication of use was NeP.||Units on a scale||Standard Deviation|Mean
829534|NCT01220180|Primary|Percentage of Participants With Improvement in Seizure Frequency in PP Population|Percentage of participants with improvement in seizure frequency of greater than or equal to 75%; greater than or equal to 50% to 74%; 0% to 49% were considered.|Baseline through Week 12|PP population included participants who received the study medication for at least 12 weeks and indication of use was epilepsy.||Percentage of participants|||Number
829535|NCT01220180|Primary|Percentage of Participants With Improvement in Seizure Frequency in ITT Population|Percentage of participants with improvement in seizure frequency of greater than or equal to 75%; greater than or equal to 50% to 74%; 0% to 49% were considered.|Baseline through Week 12|ITT population included participants who received at least 1 dose of the study medication and indication of use was epilepsy.||Percentage of participants|||Number
829553|NCT01220557|Secondary|Treatment Satisfaction / Problem Areas in Dealing With Diabetes|Satisfaction with current diabetes treatment was assessed by a diabetes satisfaction questionnaire developed by Kulzer et al. This questionnaire uncovers problems in dealing with diabetes, also. A high score indicates dissatisfaction with insulin therapy.|6 Month Follow up||||||
829536|NCT01220180|Primary|Percentage of Participants Achieving 28 Days Seizure Free Period in Per Protocol (PP) Population|Participants were regarded as seizure-free if no seizures (partial or other) were reported for the participant during the period of 28 days in the study.|Baseline through Week 12|PP population included participants who received the study medication for at least 12 weeks and indication of use was epilepsy.||Percentage of participants||95% Confidence Interval|Number
829537|NCT01220180|Primary|Percentage of Participants Achieving 28 Days Seizure Free Period in Intent-to Treat (ITT) Population|Participants were regarded as seizure-free if no seizures (partial or other) were reported for the participant during the period of 28 days in the study.|Baseline through Week 12|ITT population included participants who received at least 1 dose of the study medication and indication of use was epilepsy.||Percentage of participants||95% Confidence Interval|Number
829538|NCT01220297|Secondary|Veno-occlusive Disease (VoD)|Assessed as the incidence of veno-occlusive disease (VoD) at 100 days post-transplant.|100 days post-transplant|||Participants|||Count of Participants
829539|NCT01220297|Secondary|Overall Survival|Overall survival is defined as time from enrollment to time of death or last follow-up, within 2 years.|2 years|||Days||Full Range|Median
829540|NCT01220297|Secondary|Disease-free Survival (DFS)|Assessed as survival without recurrence of disease|2 years|||Participants|||Count of Participants
829541|NCT01220297|Secondary|Acute GvHD (Grade 3 to 4)|"Assessed as the incidence of grade 3 to 4 acute GvHD at Day 100 post-transplant.
Stage of Acute GvHD was assessed as follows.
Stage 1: Skin: rash < 25% of skin. Liver: bilirubin 2 to 3 mg/dL. Gut: diarrhea > 500 mL/day or persistent nausea with positive biopsy for GvHD
Stage 2: Skin: rash 25 to 50% of skin. Liver: bilirubin 3 to 6 mg/dL. Gut: diarrhea >1000 mL/day.
Stage 3: Skin: rash > 50% of skin. Liver: bilirubin 6 to 15 mg/dL. Gut: diarrhea > 1500 mL/day.
Stage 4: Skin: generalized erythroderma with bulla formation. Liver: bilirubin > 15 mg/dL. Gut: severe abdominal pain with or without ileus
Grade of Acute GvHD was determined as follows.
Grade 1: Stage 1-2 Skin + No Liver stage + No Gut stage
Grade 2: Stage 3 Skin OR Stage 1 Liver or Stage 1 Gut
Grade 3: No Skin stage + Stage 2 to 3 Liver Stage 2 to 4 Gut
Grade 4: Stage 4 Skin + or Stage 2 to 3 Liver + No Gut stage"|100 days post-transplant|||Participants|||Count of Participants
829542|NCT01220297|Primary|Acute Graft-vs-Host Disease (GvHD) (Grade 2 to 4)|"Assessed as the incidence of grade 2 to 4 acute graft-vs-host disease (GvHD) at Day 100 post-transplant.
Stage of Acute GvHD was assessed as follows.
Stage 1: Skin: rash < 25% of skin. Liver: bilirubin 2 to 3 mg/dL. Gut: diarrhea > 500 mL/day or persistent nausea with positive biopsy for GvHD
Stage 2: Skin: rash 25 to 50% of skin. Liver: bilirubin 3 to 6 mg/dL. Gut: diarrhea >1000 mL/day.
Stage 3: Skin: rash > 50% of skin. Liver: bilirubin 6 to 15 mg/dL. Gut: diarrhea > 1500 mL/day.
Stage 4: Skin: generalized erythroderma with bulla formation. Liver: bilirubin > 15 mg/dL. Gut: severe abdominal pain with or without ileus
Grade of Acute GvHD was determined as follows.
Grade 1: Stage 1-2 Skin + No Liver stage + No Gut stage
Grade 2: Stage 3 Skin OR Stage 1 Liver or Stage 1 Gut
Grade 3: No Skin stage + Stage 2 to 3 Liver Stage 2 to 4 Gut
Grade 4: Stage 4 Skin + or Stage 2 to 3 Liver + No Gut stage"|100 days post-transplant|||Participants|||Count of Participants
829543|NCT01220401|Primary|Past Week Nightmare Frequency|This fill-in-the-blank variable assesses the number of nightmares experienced in the past week (range = 0 - X nightmares). Higher values indicate more nightmares (worse outcome).|pre, one week, two months|||nightmares/week||Standard Deviation|Mean
829544|NCT01220401|Secondary|Beck Depression Inventory|This 21-item, self-report measure was designed to assess the severity of depression among adults. Responses on a Likert-type scale range from 0 – 3, and scores may be summed to derive a total score (0-63), with higher scores indicating more depressive symptoms. Scores of 18 and above have been suggested to reliably identify depressed patients.|Baseline, 1 week, 2 months|||units on a scale||Standard Deviation|Mean
829545|NCT01220401|Primary|Clinician Administered PTSD Scale|"This semi-structured clinical interview assesses each of 17 DSM-IV-TR criteria for PTSD utilizing separate queries for frequency and severity on a 5-point scale (0 – 4). This study utilized the “FI/I2” rule, where frequency ratings of one or more and intensity ratings of two or more must be present in order for a symptom to count towards diagnosis.
Total scores are comprised of the three factors (reexperiencing, avoidance, and hyperarousal), with 136 being the maximum. 0-19 = asymptomatic or few symptoms. 20-39 = mild PTSD, subthreshold. 40-59 = moderate PTSD at threshold. 60-79 = severe PTSD. 80+ = extreme PTSD."|pre, one week, two months|||units on a scale||Standard Deviation|Mean
829546|NCT01220401|Primary|Number of Nights With Nightmares|This fill-in-the-blank variable assesses the number of nights the individual experienced nightmares in the past week (range = 0 - 7 nights). Higher values indicate more nights with nightmares (worse outcome).|pre, one week, two months|||nights/week||Standard Deviation|Mean
829547|NCT01220466|Other Pre-specified|Percentage of Eyes With Induced Manifest Refractive Astigmatism Greater Than 2.00 D of Absolute Cylinder as Compared to the Preoperative Refraction|Induced Manifest Refractive Astigmatism is an increase of astigmatism (cylinder) postoperatively that could be caused by the refractive treatment. An increase of greater than 2.0 D is considered a safety endpoint per ANSI Z80.11-2007.|6 Months|Percentage of eyes with induced manifest refractive astigmatism greater than 2.00 D of absolute cylinder power||percentage of eyes|Participants|95% Confidence Interval|Number
829548|NCT01220466|Other Pre-specified|Percentage of Eyes With Best Spectacle Corrected Visual Acuity (BSCVA) Worse Than 20/40||6 Months|Percentage of eyes with BSCVA worse than 20/40||percentage of eyes|Participants|95% Confidence Interval|Number
829549|NCT01220466|Other Pre-specified|Percentage of Eyes With Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA)||6 Months|Percent of eyes that lost more than 2 lines of BSCVA.||percentage of eyes|Participants|95% Confidence Interval|Number
829550|NCT01220466|Other Pre-specified|Percentage of Eyes With Manifest Refraction Spherical Equivalent Within 1.0 D||6 months|Percent of eyes that achieved manifest refraction spherical equivalent within 1.0 D||percentage of eyes|Participants|95% Confidence Interval|Number
829551|NCT01220466|Primary|Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better.||6 months|UCVA is reported as percentage of eyes not percentage of subjects achieving UCVA of 20/40 or better||percentage of eyes|Participants|95% Confidence Interval|Number
829552|NCT01220557|Secondary|Evaluation of the Diabetes Education Course|Patients satisfaction with the diabetes education programs was assessed using a self-constructed 12-item scale on specific questions regarding contents and performance of the training. Response mode was a scale ranging from 4 (apply very strong) to 0 (apply not at all). Additionally, patients were asked to give an overall grade for their course ranging from 1 (very good) to 6 (unsatisfactory).|6 month Follow up||||||
829556|NCT01220557|Secondary|Diabetes Distress Scale (DDS)|Diabetes related distress was assessed by a German version of the Diabetes Distress Scale (DDS). The DDS is a 17-item self-report scale for the assessment of emotional burdens in diabetes treatment in both type 1 and type 2 diabetes.|6 month follow up||||||
829557|NCT01220557|Secondary|Summary of Diabetes Self-Care Activities (SDSCA)|The Summary of Diabetes Self-Care Activities (SDSCA) measure is a self-report measure of diabetes self-management assessing several aspects of the diabetes regimen.|6 month||||||
829558|NCT01220557|Secondary|Diabetes Empowerment Score (DES)|Empowerment was measured by a German version of the Diabetes Empowerment Scale, a measure of diabetes-related psychosocial self-efficacy.|6 month follow up||||||
829559|NCT01220557|Secondary|Hypoglycaemia Awareness Score|The hypoglycemia awareness questionnaire provides a score indicating the severity of hypoglycaemia unawareness. This scale ranges from 0 (maximum hypoglycaemia awareness) to 7 (minimum hypoglycaemia awareness), where a score of 4 suggests reduced hypoglycaemia awareness.|6 month||||||
829560|NCT01220557|Secondary|Diabetes Knowledge|To assess knowledge among insulin-treated diabetes patients, participants completed a new developed 11-item diabetes knowledge score. Each item had to be answered by selecting the correct answer from multiple choices. The numbers of correct answers are summed up; thus, the range of the diabetes knowledge score is between 0 and 11.|6 month||||||
829561|NCT01220557|Primary|Changes in Glycemic Control Measured by A1c|Difference between baseline A1c and A1c at 6 month follow up. Equivalent effect on glycemic control measured by A1c (non-inferiority). In case of-non-inferiority test of superiority.|6 month|||Changes in A1c in percentage points||Standard Deviation|Mean
829562|NCT01220609|Secondary|Overall Survival|Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.|From study entry to death or last contact, up to 5 years of follow-up.|Eligible and treated patients.||months||95% Confidence Interval|Median
829563|NCT01220609|Secondary|Progression-free Survival|Progression-free survival is the period of time from study entry to time of disease progression, death or date of last contact, whichever occurs first.|From study entry to disease progression, death or date of last contact, whichever occurs first, up to 5 years of follow-up.|Eligible and treated patients||months||95% Confidence Interval|Median
829564|NCT01220609|Primary|Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0||Every cycle until completion of study treatment up to 30 days after stopping study treatment||||||
829565|NCT01220609|Primary|Tumor Response|Complete and Partial Tumor Response as assessed by RECIST 1.1|Every other cycle for the first 6 months; then every 3 months thereafter until completion of study treatment; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.|Eligible and treated patients||percentage of participants||90% Confidence Interval|Number
829566|NCT01220739|Primary|Percentage of Participants With Modified Rankin Scale (0 - 1)|Measures the degree of disability or dependence in the daily activities. Minimum score = 0 (best outcome - No symptoms); Maximum Score = 6 (worse outcome - dead)|90 Days from Stroke Onset|||percentage of participants|||Number
829567|NCT01220739|Primary|Symptomatic Intracranial Hemorrhages||36 hours from tPA initiation|||participants|||Number
829568|NCT01220869|Secondary|Cumulative Probability of no PSA Failure|The time to PSA failure was defined as the days from first dosing (scheduled trial days) where an increase in serum PSA of ≥50% from nadir and at least 5 ng/mL measured on two consecutive occasions at least two weeks apart was noted. The second occasion was the time point of meeting the criterion. The Kaplan-Meier estimate and associated 95% CI were provided.|Day 0, Day 7, Day 28, Day 112, Day 140, Daý 168|The data of all participants who received at least one dose of degarelix and had at least one efficacy assessment after dosing comprised the FAS dataset.||Percentage of participants||95% Confidence Interval|Mean
829569|NCT01220869|Other Pre-specified|Cumulative Probability of Participants With Testosterone at Castrate Level <= 0.5 ng/mL From Day 28 to Day 168 - Sensitivity Analysis|Kaplan-Meier estimates of the cumulative probability of testosterone levels below castrate level (<= 0.5 ng/mL) from Day 28 to Day 168 and the associated two-sided 95% CI was based on log-log transformation, Greenwood's formula, and asymptotic maximum likelihood theory. The primary objective was met if the lower limit of this two-sided 95% CI was ≥90%. The definition of the primary endpoint was the Day 28 to Day 168 cumulative probability of testosterone levels below castrate levels (≤0.5 ng/mL). Only patients with a testosterone value on Day 28 and after were included in this analysis. Patients who did not experience a testosterone suppression (≤0.5 ng/mL) were censored at the time of last available testosterone measurement. The FAS analysis results were considered primary, whereas the corresponding PP analysis served as the sensitivity analysis.|From Day 28 to Day 168|The PP analysis set included all participants from the FAS analysis set without major protocol violations.||Percentage of participants||95% Confidence Interval|Mean
829570|NCT01220869|Secondary|Percentage Change in Serum Prostate Specific Antigen (PSA) Levels From Baseline (Day 0) to Day 28|Percentage change in serum prostate specific antigen (PSA levels from Baseline (Day 0) to Day 28|From Day 0 to Day 28|The data of all participants who received at least one dose of degarelix and had at least one efficacy assessment after dosing comprised the FAS dataset||Percentage change of PSA||Inter-Quartile Range|Median
829571|NCT01220869|Secondary|Proportion of Participants With Testosterone at Castrate Level (<= 0.5 ng/mL) at Day 3|Proportion of participants with testosterone at castrate level (<= 0.5 ng/mL) at Day 3|Day 3|The data of all participants who received at least one dose of degarelix and had at least one efficacy assessment after dosing comprised the FAS dataset||Percentage of participants||95% Confidence Interval|Mean
829582|NCT01227265|Secondary|"Change From Baseline in Average On Time (Hours Per Day) Without Troublesome Dyskinesia at Week 12"|"On time is when a PD participant's symptoms are improved. Mean on time without troublesome dyskinesias is derived from the available diary data collected for 3 days immediately prior to a clinic visit. On time without troublesome dyskinesia is the sum of on time without dyskinesia plus on time with non-troublesome dyskinesia as recorded in the diary. The mean change from baseline in on time was based on a cLDA with treatment, time, and treatment-by-time interaction as fixed effects and subject as random effect."|Baseline and Week 12|Full Analysis Set (FAS): All randomized participants remaining after participants were excluded for failure to receive at least one dose of study treatment, lack of any post-randomization endpoint data subsequent to at least 1 dose of study treatment, or lack of Baseline data for those analyses requiring Baseline data.||hours per day||Standard Error|Mean
829572|NCT01220869|Primary|Cumulative Probability of Participants With Testosterone at Castrate Level <= 0.5 ng/mL From Day 28 to Day 168|Kaplan-Meier estimates of the cumulative probability of testosterone levels below castrate level (<= 0.5 ng/mL) from Day 28 to Day 168 and the associated two-sided 95% confidence interval (CI) was based on log-log transformation, Greenwood’s formula, and asymptotic maximum likelihood theory. The primary objective was met if the lower limit of this two-sided 95% CI was ≥90%. The definition of the primary endpoint was the Day 28 to Day 168 cumulative probability of testosterone levels below castrate levels (≤0.5 ng/mL). Only patients with a testosterone value on Day 28 and after were included in this analysis. Patients who did not experience a testosterone suppression (≤0.5 ng/mL) were censored at the time of last available testosterone measurement. The full analysis set (FAS) results were considered primary, whereas the corresponding per protocol (PP) analysis served as the sensitivity analysis.|From Day 28 to Day 168|The data of all participants who received at least one dose of degarelix and had at least one efficacy assessment after dosing comprised the FAS dataset.||Percentage of participants||95% Confidence Interval|Mean
829573|NCT01221090|Secondary|Quality of Life (QOL)|Participants where asked the number of days in the past 30 days in which their physical (phys) and/or mental was not good, and whether their usual activity was affected by their physical/mental health.|12 months|Participants were included if they completed the 12-mo follow-up questionnaire. They also had to have answered questions pertaining to quality of life. Missing responses were not included.||Number of days||Standard Deviation|Mean
829574|NCT01221090|Secondary|Diabetes-related Behaviors|Participants were asked the number of days in the past 7 which they participated in various diabetes self-care activities on diet, exercise, home blood glucose monitoring, and foot care.|12 months|Those who completed a questionnaire at baseline and at their 12-month visit were included. Also, they had to have answered questions regarding self-care activities on both surveys since the calculated mean was the average difference in days within the past 7 that individuals participated in self-care activities between 12-months and baseline.||Days (e.g., Avg diff 12mo vs baseline)||Standard Deviation|Mean
829575|NCT01221090|Secondary|Patient Self-reported Perceived Health Status||12 months|Perceived health status was collected using a questionnaire administered during the 12-month follow-up visit. Individuals who did not complete the questionnaire during the follow-up visit or who refused to answer the question were not included in the analysis.||participants|||Number
829576|NCT01221090|Secondary|BMI|Body mass index|12 months|BMI was computed from height & weight measurements from the 12-month follow-up (f/u) visit. Those unable to come in had height and weight abstracted from their EHRs. Measures recorded fell within the range of 10 days prior to and 45 days after participants’ f/u visit dates. Those missing this information was not included in the analysis.||kg/m^2||Standard Deviation|Mean
829577|NCT01221090|Primary|HbA1c|Measures of HbA1c were collected from electronic health records dating back six months prior to orientation to the last day of study participation (45 days after the 12-month follow-up period). If a participant did not have any HbA1c value within the electronic health record for any particular follow-up visit, a lab test was scheduled to obtain a measure. Of the HbA1c collected six months prior to orientation, the value measured closest to the orientation date was considered as the baseline HbA1c value. HbA1c values that were measured on dates preceding the baseline HbA1c were not included; i.e., HbA1c values included in the analysis were those collected since the baseline HbA1c and until the last day of study participation.|12 months|A participant was included in the analysis if he/she had a HbA1c value collected. A longitudinal analysis was performed, with participants contributing one or more HbA1c values to the model. As such, all participants had at least one HbA1c value and were therefore included in the model.||percentage of gycosylated HbA1c|Participants|Standard Deviation|Mean
829578|NCT01227265|Primary|Change From Baseline in Total Epworth Sleepiness Scale (ESS) at Week 12|The ESS is a self-administered questionnaire providing a measure of a person’s general level of daytime sleepiness, or their average sleep propensity in daily life. The scale consists of 8 situations in which the participant rates their tendency to become sleepy on a scale of 0=no chance of dozing to 3=high chance of dozing. The overall score is the sum of the scores for the 8 situations for a minimum of 0 and a maximum of 24 with a higher score indicating greater sleepiness. The mean change from baseline in total EES was based on a cLDA with treatment, time, and treatment-by-time interaction as fixed effects and subject as random effect.|Baseline and Week 12|All Participants as Treated (APaT): All participants who received at least one (1) dose of study drug.||Score on a Scale||Standard Error|Mean
829579|NCT01227265|Primary|Percentage of Participants With Suicidality|The percentage of participants with suicidality using the Columbia - Suicide Severity Rating Scale (C-SSRS) was reported. The C-SSR was used in this study only for the purpose of safety monitoring by measuring the incidence of different types of suicidality categories during treatment. The assessment was done by the nature of the responses, not by a numbered scale. Participants who reported at least one occurrence of suicidal behavior or suicidal ideation were counted as having experienced suicidality. Suicidal behavior included suicide attempt, aborted attempt, interrupted attempt, or preparatory behavior. Suicidal ideation included a wish to die or active suicidal thought with or without method, intent or plan.|Up to Week 12|All Participants as Treated (APaT): All participants who received at least one (1) dose of study drug.||Percentage of participants|||Number
829580|NCT01227265|Primary|Number of Participants With Diastolic Blood Pressure (DBP) ≥105 mmHg and 15 mmHg Increase|The number of participants with Diastolic Blood Pressure (DBP) ≥105 mmHg and 15 mmHg increase was reported. Participants lie supine at rest for 5 minutes, then have a single BP measurement taken (ie, 1 reading). Participants then stand for 3 minutes at rest, followed by a single BP measurement (1 reading) in the standing position.|Up to Week 14|All Participants as Treated (APaT): All participants who received at least one (1) dose of study drug.||Participants|||Number
829581|NCT01227265|Primary|Number of Participants With Systolic Blood Pressure (SBP) ≥180 mmHg and 20 mmHg Increase|The number of participants with Systolic Blood Pressure (SBP) ≥180 mmHg and 20 mmHg increase was reported. Participants lie supine at rest for 5 minutes, then have a single BP measurement taken (ie, 1 reading). Participants then stand for 3 minutes at rest, followed by a single BP measurement (1 reading) in the standing position.|Up to Week 14|All Participants as Treated (APaT): All participants who received at least one (1) dose of study drug.||Participants|||Number
829620|NCT01227421|Secondary|Influenza Antibody Response Titer Change: Influenza A 2009 H1N1|change in influenza antibody titer for Influenza A 2009 H1N1|28 days|Member of the intensive virologic follow up group with laboratory confirmed Influenza A 2009 H1N1||Fold change in antibody titer||Inter-Quartile Range|Median
829583|NCT01227265|Secondary|"Percentage of Participants With >30% Change (Reduction) From Baseline at Week 12 in Mean Off Time"|"A participant with at least a 30% reduction in mean off time from Baseline to End of Treatment (Week 12) is considered as responder. The on state is defined as the period of time during which a patient's symptoms of PD improve or disappear following treatment with L-dopa or dopamine agonists. The off state is defined as the period of time characterized by the return of symptoms (i..e. tremor, slowness, and rigidity) following treatment with L-dopa or dopamine agonists. Study participants reported their symptoms at half-hour intervals as off, on, or asleep on their daily diary for 3 days before randomization and for the 3 days immediately before their Week 12 visit."|Baseline and Week 12|Full Analysis Set (FAS): All randomized participants remaining after participants were excluded for failure to receive at least one dose of study treatment, lack of any post-randomization endpoint data subsequent to at least one dose of study treatment, or lack of Baseline data for those analyses requiring Baseline data.||Percentage of participants|||Number
829584|NCT01227265|Primary|"Change From Baseline in Average Off Time (Hours Per Day) at Week 12"|"The on state is defined as the period of time during which a patient's symptoms of PD improve or disappear following treatment with L-dopa or dopamine agonists. The off state is defined as the period of time characterized by the return of symptoms (i..e. tremor, slowness, and rigidity) following treatment with L-dopa or dopamine agonists. Study participants reported their symptoms at half-hour intervals as off, on, or asleep on their daily diary for 3 days before randomization (baseline) and for the 3 days immediately before their Week 12 visit. The mean change from baseline in off time was based on a constrained longitudinal data analysis (cLDA) with treatment, time, and treatment-by-time interaction as fixed effects and subject as random effect."|Baseline and Week 12|Full Analysis Set (FAS): All randomized participants remaining after participants were excluded for failure to receive at least one dose of study treatment, lack of any post-randomization endpoint data subsequent to at least 1 dose of study treatment, or lack of Baseline data for those analyses requiring Baseline data.||hours per day||Standard Error|Mean
829585|NCT01227278|Secondary|Change From Baseline in Body Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity (BODE) Scores at Day 393|The BODE index is a multi-dimension COPD grading system that incorporates body-mass index (B), degree of airflow obstruction (O), dyspnea (D), and exercise capacity (E) as measured by the modified medical research council (MMRC) dyspnea scale and the 6-minute walk test. The MMRC dyspnea scale is a 5-point scale that measures the level of dyspnea (trouble breathing) experienced by participants where score range is 0 (none) to 4 (very severe ). BODE score is derived into a score range of 0 (healthy) to 10 (severe COPD).|Baseline, Day 393|The PP population included all participants who had no major protocol violations, received at least 6 of the 8 total doses of investigational product, and completed the study through Day 393. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||units on scale||Standard Deviation|Mean
829586|NCT01227278|Secondary|Percentage of Participants With a 0.5-Point Improvement in Chronic Respiratory Questionnaire Self-administered Standardized Format (CRQ-SAS) Domain Scores at Day 393|The CRQ-SAS is a self-administered questionnaire which consist of 20 items across four domains: dyspnea (5 items), fatigue (4 items), emotional function (7 items), and mastery (4 items). Participants rated their experience on a 7-point scale in response to each item ranging from 1 (maximum impairment) to 7 (no impairment). Individual items were equally weighted, and domain scores were calculated as the mean of all items within each domain; domain score range: 1 (maximum impairment) to 7 (no impairment). Participants with 0.5 point improvement from baseline in the domain scores were observed.|Day 393|The PP population included all participants who had no major protocol violations, received at least 6 of the 8 total doses of investigational product, and completed the study through Day 393. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||percentage of participants|||Number
829587|NCT01227278|Secondary|Change From Baseline in Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS) Domain Scores at Day 393|The CRQ-SAS is a self-administered questionnaire which consist of 20 items across four domains: dyspnea (5 items), fatigue (4 items), emotional function (7 items), and mastery (4 items). Participants rated their experience on a 7-point scale in response to each item ranging from 1 (maximum impairment) to 7 (no impairment). Individual items were equally weighted, and domain scores were calculated as the mean of all items within each domain; domain score range: 1 (maximum impairment) to 7 (no impairment).|Baseline, Day 393|The PP population included all participants who had no major protocol violations, received at least 6 of the 8 total doses of investigational product, and completed the study through Day 393. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||units on scale||Standard Deviation|Mean
829588|NCT01227278|Secondary|Percentage of Participants With Improvement in COPD-Specific Saint George’s Respiratory Questionnaire (SGRQ-C) Total Score|SGRQ is a health related quality of life questionnaire consisting of 40 items in three domains: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). Each question’s response has a unique empirically derived weight where lowest possible weight is zero and the highest is 100. The total score and domain score were derived from the relevant items and converted to a score of 0 to 100 with a higher score indicating poorer health status. Percentage of participants with 4-point, 8-point and 12-point change from baseline in SGRQ-C total score were observed.|Day 393|The PP population included all participants who had no major protocol violations, received at least 6 of the 8 total doses of investigational product, and completed the study through Day 393. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||percentage of participants|||Number
829602|NCT01227395|Secondary|Number of Participants Prevented by Azithromycin Treatment.|The physician performed efficacy evaluations at the end of the observation period (or the time of discontinuing administration), compared with the data before the start of administration of this drug, and entered the results.|9 years(MAX)|The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
829621|NCT01227421|Secondary|Complications of Influenza|Proportion of patients with a complication of influenza during the course of the study|28 days|All patients who received at least one dose of study medication||Participants|||Number
829589|NCT01227278|Secondary|Change From Baseline in COPD-Specific Saint George’s Respiratory Questionnaire (SGRQ-C) Total and Domain Scores at Day 393|The SGRQ is a health related quality of life questionnaire consisting of 40 items in three domains: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). Each question’s response has a unique empirically derived weight where lowest possible weight is zero and the highest is 100. The total score and domain score are derived from the relevant items and converted to a score of 0 to 100 with a higher score indicating poorer health status.|Baseline, Day 393|The PP population included all participants who had no major protocol violations, received at least 6 of the 8 total doses of investigational product, and completed the study through Day 393. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||units on scale||Standard Deviation|Mean
829590|NCT01227278|Secondary|Annual Incidence Rate of Hospitalization Due to Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)|An AECOPD is defined as worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days. Annualized Incidence Rate of hospitalization due to AECOPD was calculated as Rate = total number of hospitalizations/ total person years.|Day 1 up to 393|The PP population included all participants who had no major protocol violations, received at least 6 of the 8 total doses of investigational product, and completed the study through Day 393.||hospitalizations/person-year||95% Confidence Interval|Number
829591|NCT01227278|Secondary|Percentage of Participants Hospitalized Due to Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)|An AECOPD is defined as worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days.|Day 1 up to 393|The PP population included all participants who had no major protocol violations, received at least 6 of the 8 total doses of investigational product, and completed the study through Day 393.||percentage of participants|||Number
829592|NCT01227278|Secondary|Number of Participants Hospitalized Due to Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)|An AECOPD is defined as worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days.|Day 1 up to 393|The PP population included all participants who had no major protocol violations, received at least 6 of the 8 total doses of investigational product, and completed the study through Day 393.||participants|||Number
829593|NCT01227278|Secondary|Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between administration of study drug and up to Day 561 that were absent before treatment or that worsened relative to pre-treatment state. TEAEs reported below included both SAEs and non-serious AEs.|Day 1 up to 561|The safety population included all participants who received at least one dose of investigational drug.||participants|||Number
829594|NCT01227278|Primary|Annualized Incidence Rate of Moderate or Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)|An AECOPD is defined as worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days. Annualized Incidence Rate of Moderate or Severe AECOPD was assessed based on AECOPD data up to Day 393 (Rate = total number of moderate or severe AECOPD in each group/total person-year follow-up in each group). The severity of an exacerbation of COPD is defined as: a) Mild exacerbations, which require treatment with an increase in usual therapy, example (eg), increase use of short acting bronchodilators, b) Moderate exacerbations which require treatment with systemic corticosteroids, and or antibiotics and c) Severe exacerbations which require hospitalization.|Day 1 up to 393|The per protocol (PP) population included all participants who had no major protocol violations, received at least 6 of the 8 total doses of investigational product, and completed the study through Day 393.||AECOPD events/person-year||95% Confidence Interval|Number
829595|NCT01227382|Secondary|Adverse Events|Adverse events were prospectively evaluated at the end of the procedure, at discharge from the endoscopy unit, and by telephone call 24 hours post procedure. Adverse events were defined and graded using the 2010 American Society for Gastrointestinal Endoscopy consensus criteria.|24 hours|Percentage of participants with accurate diagnoses of cancer||participants|||Number
829596|NCT01227382|Secondary|Sampling Times for Each Device|The sampling time of the Spybite Biopsy forceps was compared to both the cytology brush and the RJ3 biopsy forceps of any stricture or biliary lesions found on Endoscopic Retrograde Cholangiopancreatography (ERCP).|15 minutes|Percentage of participants with accurate diagnoses of cancer||minutes||Standard Deviation|Mean
829597|NCT01227382|Secondary|Cholangioscopy Visualization Time|The portion of the total ERCP time spent on Cholangioscopy visualization.|30 minutes|Percentage of participants with accurate diagnoses of cancer||minutes||Standard Deviation|Mean
829598|NCT01227382|Secondary|Total Cholangioscopy Time|This is the total time it takes for the dye to be performed during the ERCP.|60 minutes|Percentage of participants with accurate diagnoses of cancer||minutes||Standard Deviation|Mean
829599|NCT01227382|Secondary|Total Procedure Time|The total time to perform ERCP|120 minutes|Percentage of participants with accurate diagnoses of cancer||minutes||Standard Deviation|Mean
829600|NCT01227382|Secondary|Procedure Technical Success|The procedure technical success was defined when all of the following criteria were met: Successful advancement of the cholangioscope to the desired target, adequate cholangioscopic visualization of the area of interest, and successful applications of of all sampling maneuvers with visible tissue seen macroscopically when obtaining mini forceps and standard forceps biopsy samples.|day 1|Percentage of participants with accurate diagnoses of cancer||participants|||Number
829601|NCT01227382|Primary|Percentage of Participants With Accurate Diagnoses of Cancer|The diagnostic accuracy of the Spybite Biopsy forceps was compared to both the cytology brush and the RJ3 biopsy forceps sampling of any stricture or biliary lesions found on Endoscopic Retrograde Cholangiopancreatography (ERCP). All three methods were used at baseline to obtain a sample for the determination of cancer vs. no cancer.|up to 7 days after the procedure|Percentage of participants with accurate diagnoses of cancer||percentage of accurate diagnoses|||Number
829603|NCT01227395|Secondary|Number of Participants That Responded to Azithromycin Treatment.|The physician performed efficacy evaluations at the end of the observation period (or the time of discontinuing administration), compared with the data before the start of administration of this drug, and entered the results.|9 years(MAX)|The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
829604|NCT01227395|Primary|Risk Factors for the Frequency of Treatment Related Adverse Events -Allergies (Treatment).|Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether with or without allergies is significant risk factor.|9 years(MAX)|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.||participants|||Number
829605|NCT01227395|Primary|Risk Factors for the Frequency of Treatment Related Adverse Events -Renal Dysfunction (Treatment).|Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether with or without renal dysfunction is significant risk factor.|9 years(MAX)|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.||participants|||Number
829606|NCT01227395|Primary|Risk Factors for the Frequency of Treatment Related Adverse Events -Gender (Treatment).|Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin Tablets to determine whether male or female is significant risk factor.|9 years(MAX)|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.||participants|||Number
829607|NCT01227395|Primary|Risk Factors for the Frequency of Treatment Related Adverse Events -Age (Treatment).|Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether <65 years or >=65 years is significant risk factor.|9 years(MAX)|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.||participants|||Number
829608|NCT01227395|Primary|Risk Factors for the Frequency of Treatment Related Adverse Events -Allergies (Prophylaxis).|Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether with or without allergies is significant risk factor.|9 years(MAX)|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.||participants|||Number
829609|NCT01227395|Primary|Risk Factors for the Frequency of Treatment Related Adverse Events -Renal Dysfunction (Prophylaxis).|Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether with or without renal dysfunction is significant risk factor.|9 years(MAX)|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.||participants|||Number
829610|NCT01227395|Primary|Risk Factors for the Frequency of Treatment Related Adverse Events -Concomitant Drugs (Prophylaxis).|Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin Tablets to determine whether with or without concomitant drugs is significant risk factor.|9 years(MAX)|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drugs was confirmed.||participants|||Number
829611|NCT01227395|Primary|Risk Factors for the Frequency of Treatment Related Adverse Events -Gender (Prophylaxis).|Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin Tablets to determine whether male or female is significant risk factor.|9 years(MAX)|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.||participants|||Number
829612|NCT01227395|Primary|Risk Factors for the Frequency of Treatment Related Adverse Events -Age (Prophylaxis).|Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether <65 years or >=65 years is significant risk factor.|9 years(MAX)|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.||participants|||Number
829613|NCT01227395|Primary|Number of Unlisted Treatment Related Adverse Events in Japanese Package Insert.|Adverse events mean all unfavorable events that occur in participants after administration of Azithromycin, irrespective of causal relationship to Azithromycin (including clinically problematic abnormal changes in laboratory test values). Number of Treatment Related Adverse Events were evaluated in company with the causal relationship to Azithromycin. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert.|9 years(MAX)|No statistical analysis provided for the number of the unlisted treatment related adverse events in Japanese Package Insert.||Events|||Number
829614|NCT01227395|Primary|Number of Participants With the Frequency of Treatment Related Adverse Events.|Adverse events mean all unfavorable events that occur in participants after administration of Azithromycin, irrespective of causal relationship to Azithromycin (including clinically problematic abnormal changes in laboratory test values). Treatment related Adverse Events were evaluated in company with the causal relationship to Azithromycin.|9 years(MAX)|No statistical analysis provided for the frequency of treatment related adverse events.||participants|||Number
829615|NCT01227421|Secondary|Influenza Antibody Response: Seroprotection and Seroconversion for Influenza B|Proportion of patients seroprotected and seroconverted at day 28|28 days|Members of intensive virologic follow up group with laboratory confirmed Influenza B||Participants|||Number
829616|NCT01227421|Secondary|Influenza Antibody Response: Seroprotection and Seroconversion for Patients With Influenza A H3N2|Proportion of patients seroprotected and seroconverted at day 28|28 days|Members of intensive virologic follow up group with laboratory confirmed Influenza A H3N2||Participants|||Number
829617|NCT01227421|Secondary|Influenza Antibody Response: Seroprotection and Seroconversion for Patients With Influenza A 2009 H1N1|Proportion of patients seroprotected or seroconverted at day 28|28 days|Members of intensive virologic follow up group with laboratory confirmed Influenza A 2009 H1N1||Participants|||Number
829618|NCT01227421|Secondary|Influenza Antibody Response: Influenza B|Change in antibody titer for Influenza B|28 days|Members of intensive virologic follow up group with laboratory confirmed Influenza B||Fold change in antibody titer||Inter-Quartile Range|Median
829619|NCT01227421|Secondary|Influenza Antibody Response: Influenza A H3N2|Change in antibody titer for Influenza A H3N2|28 days|Members of the intensive virologic follow up group with laboratory confirmed influenza A H3N2||Fold change in antibody titer||Inter-Quartile Range|Median
829623|NCT01227421|Secondary|Symptom Severity Score Hours|Sum of the symptom severity score hours from first dose to resolution of symptoms. Patients rated each symptom's severity on a score from 0 to 3 (0=absent, 1=mild, 2=moderate, 3=severe). Total symptom severity score hours were calculated by multiplying the sum of the severity scores by duration of symptoms.|28 days|Analysis conducted for 257 patients with laboratory confirmed influenza||symptom score *hour||Standard Deviation|Mean
829624|NCT01227421|Secondary|Time to Return to Normal Daily Activities|Time in hours as reported by patient|28 days|Analysis conducted on 257 patients with laboratory confirmed influenza||Hours||Inter-Quartile Range|Median
829625|NCT01227421|Secondary|Time to Cessation of Viral Shedding Measure by 50% Tissue Culture Infective Dose (TCID50)|Median time in hours|28 days|Analysis performed on 107 patients from the intensive virologic follow up population with laboratory confirmed influenza||Hours||Inter-Quartile Range|Median
829626|NCT01227421|Secondary|Mean Change in RT-PCR (Reverse Transcription Polymerase Chain Reaction) Viral Titer From Baseline|Change in viral titer logarithm with base 10 (log10) Ribonucleic Acid (RNA)copies|7 days|Analysis conducted on 113 patients from the intensive virologic follow up group with laboratory confirmed influenza||LOG10 RNA copies||Standard Deviation|Mean
829627|NCT01227421|Secondary|Mean Change (Standard Deviation)in 50% Tissue Culture Infective Dose (TCID50) Viral Titer From Baseline|Change in viral titer presented as logarithm with base 10 (log10) 50% Tissue Culture Infective Dose (TCID50)|7 days|Analysis conducted on 113 patients from intensive virologic follow up group with laboratory confirmed influenza||LOG10 Titer||Standard Deviation|Mean
829628|NCT01227421|Secondary|Time to Resolution of Each Individual Symptom of Influenza as Reported by the Subjects|Time in hours (Median and Interquartile range)|at least 28 days|624 patients were enrolled based on inclusion/exclusion criteria. Secondary efficacy analyses were conducted on the 257 patients with laboratory confirmed influenza.||Hours||Inter-Quartile Range|Median
829629|NCT01227421|Primary|Time to Resolution of All Clinical Symptoms of Influenza as Reported by the Subjects|The primary efficacy analysis for this study was to demonstrate the efficacy of Nitazoxanide (NTZ) administered as 300 mg b.i.d. for 5 days or 600 mg b.i.d. for 5 days in reducing the time to resolution of all clinical symptoms of influenza in patients with laboratory confirmed influenza infection|Up to 28 days|624 patients were enrolled based on inclusion/exclusion criteria. The primary efficacy analysis was conducted on the 257 patients with laboratory confirmed influenza.||Hours||Inter-Quartile Range|Median
829630|NCT01227434|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|The number of participants with protocol related toxicity described by CTCAE version 4.0|1-2 years|||participants|||Number
829631|NCT01227434|Primary|Progression Free Survival|Efficacy of the small molecule CDK4/6 inhibitor PD 0332991 in patients with recurrent glioblastoma multiforme or gliosarcoma who are Rb positive was measured by progression free survival. A total of 30 patients was intended to be treated; up to 15 patients were to undergo a planned, intended surgical resection and receive drug for 7 days prior to surgery, followed by drug after recovery from surgery; and up to 15 patients were to receive drug without a planned surgical procedure.|up to 142 weeks|||weeks||Full Range|Mean
829632|NCT01228591|Secondary|Subject Reported Vision at Initial Fit Using Contact Lens User Experience (CLUE)|Vision at initial fit was assessed using a subjective vision questionnaire. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0 to 120.|Baseline|Subjects analyzed included only those who were enrolled and completed the study.||CLUE points||Standard Error|Least Squares Mean
829633|NCT01228591|Secondary|Contact Lens Comfort at Initial Fit Using Contact Lens User Experience (CLUE)|Comfort was assessed using a subjective comfort questionnaire. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. CLUE scores have a range of 0-120.|Baseline|Analysis was on those who were enrolled and completed the study.||CLUE points||Standard Error|Least Squares Mean
829634|NCT01228591|Secondary|Subject Reported Vision Using Contact Lens User Experience (CLUE).|Overall vision was assessed by a subjective vision questionnaire. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0 to 120.|1 week|Analysis was on those who were enrolled and completed the study.||CLUE points||Standard Error|Least Squares Mean
829635|NCT01228591|Secondary|Contact Lens Comfort Using Contact Lens User Experience (CLUE)|The subjective comfort questionnaire CLUE, assesses the overall lens comfort. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0 to 120.|1 week|Analysis was on those who were enrolled and completed the study.||CLUE points||Standard Error|Least Squares Mean
829636|NCT01228591|Primary|Visual Acuity at Time of Initial Fit|Visual acuity will be measured using ETDRS visual acuity test. ETDRS stands for Early Treatment Diabetic Retinopathy Study.|After 10-15 minutes of lens wear|Analysis is conducted on those were enrolled and completed the trial.||LogMAR|Participants|Standard Deviation|Mean
829637|NCT01228591|Primary|Visual Acuity One Week After Lens Wear|Visual acuity was measured using ETDRS visual acuity test. ETDRS stands for Early Treatment Diabetic Retinopathy Study. Binocular and monocular measurements were collected.|1 week|Subjects analyzed were those who were enrolled, randomized, and completed the study. Both monocular and binocular measurements were taken and included in analysis.||LogMAR|Participants|Standard Error|Least Squares Mean
829678|NCT01229150|Primary|Progression Free Survival|Time between the first day of treatment to the day of disease progression. Progressive disease is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that's the smallest on study). In addition to the relative increase of 20% of at least 5mm. (Note: the appearance of one or more lesions is also considered progression).|2.1 to 4 months|||Months||95% Confidence Interval|Median
829643|NCT01228747|Secondary|Generalized Tonic-clonic Seizure Freedom Over the Evaluation Period|A subject with a non-missing weekly generalized tonic-clonic (GTC) baseline seizure frequency and a weekly GTC seizure frequency of zero throughout the Evaluation Period, is considered as a GTC seizure-free subject on the Evaluation Period.|Evaluation Period (Week 12 to Week 28)|Of the 226 subjects in the Full Analysis Set (FAS), 205 are included in the analysis of this Outcome Measure.||participants|||Number
829644|NCT01228747|Secondary|Generalized Tonic-clonic Seizures 50 % Responder Rate (the Proportion of Subjects With 50 % or More Reduction From the Combined Baseline in the Frequency of Generalized Tonic-clonic Seizures) During the Evaluation Period|"A subject with an at least 50 % reduction in weekly generalized tonic-clonic (GTC) seizure frequency from Combined Baseline Period to the Evaluation Period is considered a GTC 50 % responder.
Combined Baseline means: a 4-week Retrospective Baseline + 4-week Prospective Baseline or 8-week Prospective Baseline"|From Baseline to Evaluation Period (Week 12 to Week 28)|Of the 226 subjects in the Full Analysis Set (FAS), 205 are included in the analysis of this Outcome Measure.||participants|||Number
829645|NCT01228747|Secondary|Generalized Tonic-clonic Seizures 50 % Responder Rate (the Proportion of Subjects With 50 % or More Reduction From the Combined Baseline in the Frequency of Generalized Tonic-clonic Seizures) During the Treatment Period|"A subject with an at least 50 % reduction in weekly generalized tonic-clonic (GTC) seizure frequency from Combined Baseline Period to the Treatment Period is considered a GTC 50 % responder.
Combined Baseline means: a 4-week Retrospective Baseline + 4-week Prospective Baseline or 8-week Prospective Baseline"|From Baseline to Week 28|Full Analysis Set consisted of all subjects in the SS who had an evaluable Baseline and at least 1 post-Baseline GTC seizure count data point for the primary efficacy analysis excluding those who had seriously violated GCP. Evaluable Baseline for the primary efficacy analysis: at least 1 GTC seizure was documented for the Combined Baseline.||participants|||Number
829646|NCT01228747|Secondary|The Percentage Change in Generalized Tonic-clonic Seizure Frequency Per Week From the Combined Baseline Over the Evaluation Period|"Percentage change in generalized tonic-clonic (GTC) seizure frequency per week from combined baseline B over the Evaluation Period A is calculated using the equation:
Percentage change from Baseline = ((A-B)/B)*100. Percentage change from baseline is not defined for subjects whose baseline Information is missing / unknown or equal to zero, or whose seizure frequency per week is missing / unknown. A negative value in change in generalized tonic-clonic (GTC) seizure frequency indicates a reduction of generalized tonic-clonic (GTC) seizure frequency.
Combined Baseline means: a 4-week Retrospective Baseline + 4-week Prospective Baseline or 8-week Prospective Baseline."|From Baseline to Evaluation Period (Week 12 to Week 28)|Of the 226 subjects in the Full Analysis Set (FAS), 205 are included in the analysis of this Outcome Measure in Evaluation Period.||Percentage Change||Standard Deviation|Mean
829693|NCT01229397|Secondary|Number of Participants With Local and Systemic Adverse Events as a Measure of Safety and Tolerability||Solicited local and systemic AEs were collected from Day 1 (day of vaccination) to Day 4 inclusive using a subject diary|Safety population, all vaccinated subjects||participants|||Number
829647|NCT01228747|Primary|Percentage Change From the Combined Baseline in the Generalized Tonic-clonic Seizure Frequency Per Week Over the 28-week Treatment Period (Dose Adjustment + Evaluation Periods)|"Percentage change in generalized tonic-clonic (GTC) seizure frequency per week from Combined Baseline B over the Treatment Period A is calculated using the equation:
Percentage change from Baseline = ((A-B)/B)*100. Percentage change from baseline is not defined for subjects whose baseline information is missing / unknown or equal to zero, or whose seizure frequency per week is missing / unknown. A negative value in change in generalized tonic-clonic (GTC) seizure frequency indicates a reduction of generalized tonic-clonic (GTC) seizure frequency over the 28-week treatment Period.
Combined Baseline means: a 4-week Retrospective Baseline + 4-week Prospective Baseline or 8-week Prospective Baseline"|From Baseline to Week 28|Full Analysis Set consisted of all subjects in the SS who had an evaluable Baseline and at least 1 post-Baseline GTC seizure count data point for the primary efficacy analysis excluding those who had seriously violated GCP. Evaluable Baseline for the primary efficacy analysis: at least 1 GTC seizure was documented for the Combined Baseline.||Percentage Change||Standard Deviation|Mean
829648|NCT01228903|Other Pre-specified|Change in Serum Uric Acid Levels From Baseline to Week 12|Serum uric acid levels were measured both at baseline and after 12 weeks|Baseline and 12 weeks|||mg/dL||Standard Deviation|Mean
829649|NCT01228903|Secondary|Change in Oxidized Low Density Lipoprotein From Baseline to Week 12||Baseline and 12 weeks|||u/L||Standard Deviation|Mean
829650|NCT01228903|Secondary|Change in Monocyte Chemotactic Protein-1 From Baseline to Week 12||Baseline and 12 weeks|-4.7||pg/mL||Standard Deviation|Mean
829651|NCT01228903|Secondary|Change in Serum Interleukin-6 From Baseline to Week 12||Baseline and 12 weeks|||pg/mL||Standard Deviation|Mean
829652|NCT01228903|Secondary|Change in C-reactive Protein From Baseline to Week 12||Baseline and 12 weeks|||mg/L||Standard Deviation|Mean
829653|NCT01228903|Primary|Change in Endothelial Dependent Dilation From Baseline to Week 12|Change in Endothelial Dependent Dilation measured by Flow Mediated Dilation at baseline and week 12|Baseline and 12 weeks|||% change||Standard Deviation|Mean
829654|NCT01228929|Primary|Change in Ocular Surface Temperature (OST)|Objectively evaluate the ocular surface temperature prior to and after 30 minutes of acclimation to three different environmental conditions in a controlled-environmental chamber using thermal imaging. 10 eyes were analyzed for each group.|baseline and 30 minutes|||degree celsius|Participants|Standard Deviation|Mean
829655|NCT01228968|Secondary|Subcutaneous Fat Volume With Manual Segmentation|This is the volume of Abdominal Subcutaneous Fat in cubic centimeters as determined with the older manual segmentation technique.|five minutes|||cubic centimeters||Standard Deviation|Mean
829656|NCT01228968|Primary|Visceral Fat Volume With Manual Segmentation|This is the measure of visceral fat found with our older manual segmentation method|five minutes|||cm3||Standard Deviation|Mean
829657|NCT01228968|Primary|Visceral Fat Volume With Automated Analysis|This is the measurement of Abdominal Visceral Fat in cubic centimeters as determined with a new automated segmentation program.|five minutes|||cubic centimeters||Standard Deviation|Mean
829658|NCT01228968|Secondary|Subcutaneous Fat Volume With Automated Analysis|This is the volume of Abdominal Subcutaneous Fat in cubic centimeters as determined with new automated anatomical segmentation software.|five minutes|||cubic centimeters||Standard Deviation|Mean
829659|NCT01229111|Secondary|Identification of Factors That Predict Survival|Factors that predict survival will be identified by Cox model or extended Cox model.|Up to three years|Statistically, due to the small sample size, analysis could not be done|||||
829660|NCT01229111|Secondary|Estimation of Overall Survival|Time of overall response|Up to 3 years|Patients that received treatment.||Months||95% Confidence Interval|Median
829661|NCT01229111|Secondary|Progression Free Survival|Time in months that evaluable subjects survived progression free|Up to 3 years|Patients that were evaluable for response||Months||95% Confidence Interval|Median
829662|NCT01229111|Secondary|Tabulation of the Toxicity Profile of the Combination Therapy|Number of patients that experienced >/= grade 3 treatment related toxicities (definite, probable, possible).|Up to 3 years|All patients that received treatment drug||participants|||Number
829663|NCT01229111|Primary|The Response Rate of Patients Evaluated Using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1|The number of patients with a Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters; Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions); Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|Up to 3 years|Patients that were evaluable||participants|||Number
829664|NCT01229150|Other Pre-specified|Number of Participants Who Underwent Mutational Analysis for Estimated Glomerular Filtration Rate (EGFR), Mitogen-activated Protein Kinase 1 (MEK 1), Proto-oncogene B-Raf (BRAF), and LKB1|Number of participants who underwent mutational analysis for EGFR, MEK 1, BRAF, and LKB1 was to be assessed by polymerase chain reaction (PCR).|At enrollment|Zero participants were analyzed because most of the immunohistochemistry (IHC) specialty assays (e.g. IHC, fluoresense in situ hybridization (FISH), polymerase chain reaction (PCR) were not available (still are not performed in path) and required funding for development that was not provided.|||||
829665|NCT01229150|Other Pre-specified|Number of Participants With Overexpression of Estimated Glomerular Filtration Rate (EGFR) and c-MET|Number of participants with over expression of EGFR and c-MET was to be assessed by fluoresense in situ hybridization (FISH).|At enrollment|Zero participants were analyzed because most of the immunohistochemistry (IHC) specialty assays (e.g. IHC, fluoresense in situ hybridization (FISH), polymerase chain reaction (PCR) were not available (still are not performed in path) and required funding for development that was not provided.|||||
829666|NCT01229150|Other Pre-specified|Phospho-ERK (p-ERK), Phospho Protein Kinase B (p-AKt) and Phosphatase and Tensin Homolog (PTEN) Expression Testing|p-ERK, p-AKt and PTEN protein expression testing was to be assessed by immunohistochemistry.|At enrollment|Zero participants were analyzed because most of the immunohistochemistry (IHC) specialty assays (e.g. IHC, fluoresense in situ hybridization (FISH), polymerase chain reaction (PCR) were not available (still are not performed in path) and required funding for development that was not provided.|||||
829667|NCT01229150|Other Pre-specified|Change in Programmed Cell Death-1 (PD-1) Expression on Cluster of Differentiation 8 (CD8)+T Cells|Fold change from cycle 1 day 1 was determined by programmed cell death-1 (PD-1) expression on CD8+ T cells measured by the median channel number of fluorescence intensity.|Cycle 1 Day 1 pre-treatment with Cycle 1 Day 2 (1 day after starting treatment), and Cycle 1 Day 14 (2 weeks after starting treatment)|These are exploratory results and a normal range has not been defined for fold change. No participants were analyzed in the WT KRAS 1 cohort because no samples were available for analysis. Missing numbers in the other cohorts were either not drawn, misplaced or the samples were not viable.||Fold change||Standard Deviation|Mean
829668|NCT01229150|Other Pre-specified|Change in Programmed Cell Death-1 (PD-1) Expression on Tregs|Fold change from cycle 1 day 1 was determined by the PD-1 expression level on Tregs measured by the median channel number of fluorescence intensity.|Cycle 1 Day 1 pre-treatment with Cycle 1 Day 2 (1 day after starting treatment), and Cycle 1 Day 14 (2 weeks after starting treatment)|These are exploratory results and a normal range has not been defined for fold change. No participants were analyzed in the WT KRAS 1 cohort because no samples were available for analysis. Missing numbers in the other cohorts were either not drawn, misplaced or the samples were not viable.||Fold change||Standard Deviation|Mean
829669|NCT01229150|Other Pre-specified|Change in Cytotoxic T-lymphocyte Associated Protein 4 (CTLA-4) Expression on Tregs|The fold change from cycle 1 day 1 was determined by the level of CTLA-4 expression on Tregs measured by the median channel number of fluorescence intensity.|Cycle 1 Day 1 pre-treatment with Cycle 1 Day 2 (1 day after starting treatment), and Cycle 1 Day 14 (2 weeks after starting treatment)|These are exploratory results and a normal range has not been defined for fold change. No participants were analyzed in the WT KRAS 1 cohort because no samples were available for analysis. Missing numbers in the other cohorts were either not drawn, misplaced or the samples were not viable.||Fold change||Standard Deviation|Mean
829670|NCT01229150|Other Pre-specified|Change in T Cell Immunoglobulin Mucin 3 (TIM-3) on Tregs|Fold change from cycle 1 day 1 was determined by TIM-3 expression level on Tregs measured by the median channel number of fluorescence intensity.|Cycle 1 Day 1 pre-treatment with Cycle 1 Day 2 (1 day after starting treatment), and Cycle 1 Day 14 (2 weeks after starting treatment)|These are exploratory results and a normal range has not been defined for fold change. No participants were analyzed in the WT KRAS 1 cohort because no samples were available for analysis. Missing numbers in the other cohorts were either not drawn, misplaced or the samples were not viable.||Fold change||Standard Deviation|Mean
829671|NCT01229150|Other Pre-specified|Number of Participants With Changes in a Tumor's MIB-1 (Ki-67) Rate|Changes in a tumor's MIB-1 (Ki-67) rate was to be assessed by immunohistochemistry.|At enrollment|Tumor MIB-1 (Ki-67) rate testing was not done because it was too costly.|||||
829672|NCT01229150|Secondary|Number of Participants With a Reduction in Phosphorylated Extracellular Signal-Regulated Kinases (p-ERK) in Lymphocytes|Level of p-ERK was measured by the median channel cumber of fluorescence intensity. Data are relative to the level before therapy begins(C1D1).Then we see what the level was after therapy & compare. Every value after therapy is compared to pre-therapy, & every patient is their own control. To do that, we make C1D1 equal to 1 for every patient & then compare the pERK level after therapy by looking at the fold change in pERK level.|Cycle 1 Day 1 pre-treatment with Cycle 1 Day 2 (1 day after starting treatment), and Cycle 1 Day 14 (2 weeks after starting treatment)|Re: number of participants analyzed: Samples were either not drawn or could not be located. WT KRAS 1/WT KRAS 2 are missing because the effect of treatment on the Ras-Raf-MEK-ERK pathway as measured by a reduction in phosphorylated extracellular signal-regulated kinases (p-ERK) in lymphocytes was evaluated in patients with KRAS-mutated tumors only.||participants|||Number
829673|NCT01229150|Secondary|Percentage of Th17 in Cluster of Differentiation 4 (CD4)+T Cells at Baseline in Relation to Response|First the number of T cells that are CD4+ is determined by staining with an antibody to CD4 and measured in a flow cytometer. Then the number of Th17+ cells is determined by staining with an antibody to IL-17 and measured in a flow cytometer. Then the percentage of CD4+ cells that are also Th17 cells is determined as a simple ratio, i.e. Th17cells/CD4 cells. This ratio is reported here for each category of KRAS mutation status for whom we had patients.|Pretreatment - Cycle 1 Day 1|No participants were analyzed in the WT KRAS 1 cohort because no samples were available for analysis. For all other cohorts, the numbers analyzed indicates some samples were either not drawn or could not be located.||Percentage of Th17 in CD4+T Cells||Standard Deviation|Mean
829674|NCT01229150|Secondary|Overall Survival|Time between the first day of treatment to the time of death.|Up to 26 months|||Months||95% Confidence Interval|Median
829675|NCT01229150|Secondary|Percentage of Participants With Disease Control/Stabilization|Disease control/stabilization is the percentage of participants with partial response (PR) + complete response (CR) + stable disease (SD). Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10mm. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. (Note: the appearance of one or more new lesions is also considered progressions.), taking as reference the smallest sum diameters.|3 cycles or up to 84 days|||percentage of participants||95% Confidence Interval|Number
829676|NCT01229150|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|42 months|The combination of toxicities allows for a more robust understanding of the combined therapy toxicities. The dosage of the combination of erlotinib plus AZD6244 was the same whether the pt has a KRAS mutation versus KRAS wild type. KRAS is a molecular mutation and does not change whether or not a pt has toxicities to the combination of therapies.||Participants|||Number
829677|NCT01229150|Primary|Objective Response|Objective response is complete response + partial response. Complete response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10mm. Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.|Up to 37 months|There were no partial or complete responses in the KRAS mut 1 arm.||participants|||Number
829679|NCT01229176|Secondary|Number of Participants With Any Solicited Local and Systemic Reaction, After Any Vaccination|"Solicited local reactions were: Adults, children, older infants, infants: erythema, induration and pain/tenderness at the injection site.
Solicited systemic reactions were: Adults: chills, malaise, myalgia, arthralgia, headache, fatigue, rash and fever.
Children, older infants and infants: lethargy, irritability, vomiting, diarrhoea, loss of appetite, rash and fever (and persistent crying in infants)."|During the 7-day follow-up period after vaccination|Analysis was done on as treated safety population.||participants|||Number
829680|NCT01229176|Primary|Anti-Vi ELISA GMC||At 6 months after last vaccination|Intention-to-treat analysis set||ELISA Units/mL||95% Confidence Interval|Geometric Mean
829681|NCT01229176|Primary|Anti-Vi ELISA Geometric Mean Concentration (GMC)||At 28 days after last vaccination|Intention-to-treat analysis set||ELISA Units/mL||95% Confidence Interval|Geometric Mean
829682|NCT01229176|Primary|Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titer||At 6 months after last vaccination as compared to baseline|Intention-to-treat analysis set||percentage of subjects||95% Confidence Interval|Number
829683|NCT01229176|Primary|Percentage of Subjects With at Least 4-fold Increase in Anti-Vi Enzyme-linked Immunosorbent Assay (ELISA) Titer||At 28 days after last vaccination as compared to baseline|Intention-to-treat analysis set, which included all participants who received the vaccination, those in whom at least one post-vaccination blood sample was collected, and those for whom at least one ELISA result was available.||percentage of subjects||95% Confidence Interval|Number
829684|NCT01229228|Primary|Analysis of Total Pain Relief (TOTPAR) Over 0 to 12 Hours (TOTPAR-12) After Time 0|"Total pain relief as computed as a time-weighted sum of individual patient pain relief scores at each timepoint from 0-12 hours.
Values for TOTPAR are measured from 0 to 4 on the Pain Relief Scale 0 None Min; 1 A little; 2 Some; 3 A lot; 4 Complete Max
The TOTPAR is a weighted measure of the observations; the minimum possible value is 0 and the maximum possible value is 60."|Over 0 to 12 Hours|||units on a scale||95% Confidence Interval|Least Squares Mean
829685|NCT01229254|Secondary|Steady-state C12 hr on Days 14, 18, and 21 After Weight and Amiodarone-based Dosing|Betrixaban PK concentration at 12 hr on Days 14, 18, and 21 in amiodarone, low and high weight groups|Days 14, 18, and 21 of the PK period|Full Analysis Set population, which includes all patients who received at least one dose of study treatment within 24 hours prior to steady-state (SS) blood sampling, were ≥ 90% compliant with treatment, and had at least one post SS sample. The endpoint was to summarize the SS C12 hr concentration across treatments and time points as a single arm.||ng/mL||90% Confidence Interval|Geometric Least Squares Mean
829686|NCT01229254|Primary|Steady-state C12 hr on Days 14, 18, and 21 After Weight-based Dosing|Betrixaban PK concentration at 12 hr on Days 14, 18, and 21 in low and high weight groups|Days 14, 18, and 21 of the PK period|Per protocol analysis set, which includes all allocated patients who received at least one dose of study treatment and who were ≥ 90% compliant with study treatment, took study treatment within 24 hours prior to steadystate blood sampling, had at least two post steady-state blood samples collected, and not on amiodarone.||ng/mL||90% Confidence Interval|Geometric Least Squares Mean
829687|NCT01229371|Primary|Immunogenicity - Seroconversion Rate|"The primary endpoints were the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA Note for guidance on harmonisation of requirements for influenza vaccines, 1997 and they were the following: 1. Seroprotection rate, defined as proportion of subjects with HI antibody titer ≥1:40, 2. Seroconversion rate, defined as proportion of subjects with ≥4-fold increase in HI antibody titer and with a titer of ≥1:40, 3. GMT of HI antibodies and fold-increase in GMT"|3 weeks after vaccination (Day 22 ± 2 days)|Intent-to-treat population, vaccinated subjects with available pre- and post-vaccination titers||percentage subjects||95% Confidence Interval|Number
829688|NCT01229371|Primary|Immunogenicity - Seroprotection Rate|"The primary endpoints were the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA Note for guidance on harmonisation of requirements for influenza vaccines, 1997 and they were the following: 1. Seroprotection rate, defined as proportion of subjects with HI antibody titer ≥1:40, 2. Seroconversion rate, defined as proportion of subjects with ≥4-fold increase in HI antibody titer and with a titer of ≥1:40, 3. GMT of HI antibodies and fold-increase in GMT"|3 weeks after vaccination (Day 22 ± 2 days)|Intent-to-treat population, vaccinated subjects with available pre- and post-vaccination titers||percentage subjects||95% Confidence Interval|Number
829689|NCT01229371|Secondary|Number of Participants With Local and Systemic Adverse Events|"Solicited local and systemic AEs, Unsolicited AEs, Tolerability and acceptability
Unsolicited AEs were collected from baseline (Day 1) to 3 weeks after vaccination (Day 22 ± 2 days).
Solicited local and systemic AEs were collected by subjects diary from Day 1 (day of vaccination) to Day 4"|Baseline (Day 1) and 3 weeks after vaccination (Day 22 ± 2 days)|Safety population, all vaccinated subjects||participants|||Number
829690|NCT01229371|Primary|Immunogenicity - Geometric Mean Titer Fold Increase From Baseline|"The primary endpoints were the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA Note for guidance on harmonisation of requirements for influenza vaccines, 1997 and they were the following: 1. Seroprotection rate, defined as proportion of subjects with HI antibody titer ≥1:40, 2. Seroconversion rate, defined as proportion of subjects with ≥4-fold increase in HI antibody titer and with a titer of ≥1:40, 3. GMT of HI antibodies and fold-increase in GMT"|3 weeks after vaccination (Day 22 ± 2 days)|Intent-to-treat population, vaccinated subjects with available pre- and post-vaccination titers||GMT fold increase||95% Confidence Interval|Number
829691|NCT01229397|Primary|Immunogenicity of a Single Full (0.5 mL) Dose and a 0.25 mL 2-dose Regimen of Inflexal V, Using the EMA Guideline for the Re-registration of the Seasonal Influenza Vaccine in Adults (Aged ≥18 to ≤60 Years) as Reference|GMT-fold increase - calculated as the GMT on Day 22 divided by the baseline GMT value|This assesment was done for immunogenicity data collected at Day 29 after completion of designated vaccination regimen|Intention to treat population, vaccinated subjects with available pre- and post-vaccination titers||Fold (ratio)||95% Confidence Interval|Number
829692|NCT01229397|Primary|Immunogenicity of a Single Full (0.5 mL) Dose and a 0.25 mL 2-dose Regimen of Inflexal V, Using the EMA Guideline for the Re-registration of the Seasonal Influenza Vaccine in Adults (Aged ≥18 to ≤60 Years) as Reference|Seroconversion rate|This assesment was done for immunogenicity data collected at Day 29 after completion of designated vaccination regimen|Intention to treat population, vaccinated subjects with available pre- and post-vaccination titers||percentage subjects||95% Confidence Interval|Number
829694|NCT01229397|Primary|Immunogenicity of a Single Full (0.5 mL) Dose and a 0.25 mL 2-dose Regimen of Inflexal V, Using the EMA Guideline for the Re-registration of the Seasonal Influenza Vaccine in Adults (Aged ≥18 to ≤60 Years) as Reference|Seroprotection rate|This assesment was done for immunogenicity data collected at Day 29 after completion of designated vaccination regimen|Intention to treat population, vaccinated subjects with available pre- and post-vaccination titers||percentage subjects||95% Confidence Interval|Number
829695|NCT01229410|Secondary|Percentage of Patient Samples With Plasma Levels of Brimonidine Below the Limit of Quantitation (BLQ)|Percentage of patient samples with plasma levels of brimonidine reported as BLQ (i.e., too low to be determined using standard methods). Plasma is the fluid portion of the blood.|60 Days|Per Protocol: all subjects with qualified pharmacokinetic samples||Percentage of Patient Samples|Participants||Number
829696|NCT01229410|Secondary|Highest Aqueous Humor Level of Brimonidine in the Study Eye|The highest level of brimonidine measured in the aqueous humor of the study eye in any patient is reported for each treatment arm. The aqueous humor is the clear fluid in the chamber of the eye between the cornea and the lens.|60 Days|Per Protocol: all subjects with pharmacokinetic data available||Nanogram/milliliter (ng/mL)|||Number
829697|NCT01229410|Primary|Highest Vitreous Humor Level of Brimonidine in the Study Eye|The highest level of brimonidine measured in the vitreous humor of the study eye in any patient is reported for each treatment arm. The vitreous humor is the clear gel that fills the space between the lens and the retina of the eye.|60 Days|Per Protocol: all subjects with pharmacokinetic data available||Nanogram/milliliter (ng/mL)|||Number
829698|NCT01229423|Secondary|Percentage of Subjects Satisfied With Treatment at Week 20|Percentage of subjects satisfied with treatment at week 20 was assessed using the Treatment Satisfaction Scale response to the question “Which best describes your satisfaction with LATISSE®?” Responses were “very satisfied”, “satisfied”, “neutral”, “unsatisfied”, and “very unsatisfied.” Satisfied is defined as responses of “very satisfied” and “satisfied.”|Week 20|Intent-to-Treat (ITT) included all patients enrolled in the trial who received at least one application of study drug.||Percentage of Subjects|||Number
829699|NCT01229423|Secondary|Percentage of Subjects With an Improvement in Satisfaction With Overall Eyelash Prominence at Week 20|Percentage of subjects with an improvement in satisfaction with overall eyelash prominence at Week 20. Subject satisfaction with overall eyelash prominence was assessed by response to the question “Overall how satisfied are you with your eyelashes?” Responses were based on a 5-point scale (“very unsatisfied”, “unsatisfied”, “neutral”, “satisfied”, “very satisfied”). Improvement in subject satisfaction is defined as a 1-point increase from baseline.|Week 20|Intent-to-Treat (ITT) included all patients enrolled in the trial who received at least one application of study drug.||Percentage of Subjects|||Number
829700|NCT01229423|Secondary|Change From Baseline in Eyelash Intensity (Darkness) at Week 20|Change from baseline in eyelash intensity (darkness) at Week 20. Assessments made were based on the mean eyelash intensity of the upper left and right eyelashes. Intensity was measured on a scale ranging from 0 (black) to 255 (white). A negative change from baseline indicates eyelash darkening in color, and a positive change from baseline indicates eyelash lightening in color.|Baseline, Week 20|Intent-to-Treat (ITT) included all patients enrolled in the trial who received at least one application of study drug.||Units on a Scale||Standard Deviation|Mean
829701|NCT01229423|Secondary|Change From Baseline in Eyelash Thickness at Week 20|Change from baseline in eyelash thickness at Week 20. Assessments made were based on the mean thickness of the upper left and right eyelashes. A positive change from baseline indicates an increase in eyelash thickness, and a negative change from baseline indicates a decrease in eyelash thickness.|Baseline, Week 20|Intent-to-Treat (ITT) included all patients enrolled in the trial who received at least one application of study drug.||Millimeters Squared (mm^2)||Standard Deviation|Mean
829702|NCT01229423|Secondary|Percentage of Subjects With an Improvement of at Least 1-Point in Global Eyelash Assessment (GEA) Score at Week 20|Percentage of subjects with an improvement of at least 1-point in GEA score at Week 20 from baseline. The GEA scale is an investigator-graded 4-point scale of overall eyelash prominence where 1=minimal, 2=moderate, 3=marked, and 4=very marked prominence.|Week 20|Intent-to-Treat (ITT) included all patients enrolled in the trial who received at least one application of study drug.||Percentage of Subjects|||Number
829703|NCT01229423|Primary|Change From Baseline in Eyelash Length at Week 20|Change from baseline in eyelash length at Week 20. Measurements made were based on the mean length of the upper left and right eyelashes. A positive change from baseline indicates an increase in eyelash length, and a negative change from baseline indicates a decrease in eyelash length.|Baseline, Week 20|Intent-to-Treat (ITT) included all patients enrolled in the trial who received at least one application of study drug.||Millimeter (mm)||Standard Deviation|Mean
829704|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Day 180 After Last Injection|TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 180 after the last injection, where last injection was a maximum up to fourth injection for a finger. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Day 180 after last injection|FAS: participants who received >= 1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.||degrees|Participants|Full Range|Median
829705|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Day 90 After Last Injection|TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 90 after the last injection, where last injection was a maximum up to fourth injection for a finger. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Day 90 after last injection|FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.||degrees|Participants|Full Range|Median
829706|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Day 30 After Fourth Injection|TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 30 after fourth injection for fingers that received 4 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Day 30 after fourth injection|FAS: participants who received >= 1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.||degrees|Participants|Full Range|Median
829707|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Day 7 After Fourth Injection|TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 7 after fourth injection for fingers that received 4 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Day 7 after fourth injection|FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.||degrees|Participants|Full Range|Median
829708|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Day 1 After Fourth Injection|TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 1 after fourth injection for fingers that received 4 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Day 1 after fourth injection|FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.||degrees|Participants|Full Range|Median
829709|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Day 30 After Third Injection|TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 30 after third injection for fingers that received 3 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Day 30 after third injection|FAS: participants who received >= 1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.||degrees|Participants|Full Range|Median
829710|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Day 7 After Third Injection|TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 7 after third injection for fingers that received 3 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Day 7 after third injection|FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.||degrees|Participants|Full Range|Median
829711|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Day 1 After Third Injection|TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 1 after third injection for fingers that received 3 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Day 1 after third injection|FAS: participants who received >= 1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.||degrees|Participants|Full Range|Median
829712|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Day 30 After Second Injection|TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 30 after second injection for fingers that received 2 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Day 30 after second injection|FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.||degrees|Participants|Full Range|Median
829728|NCT01229436|Other Pre-specified|Number of Participants With Anti-Drug Antibody (ADA)|Human serum ADA samples were analyzed for the presence or absence of anti-clostridial type I collagenase (AUX-I) and anti-clostridial type II collagenase (AUX-II) antibodies by using the semi-quantitative enzyme-linked immunosorbent assay (ELISA).|Screening, Follow-up Day 180 after last injection|Safety set included all participants who received at least 1 injection of Xiapex. 'Number of participants' analyzed signifies those participants who were evaluable for this outcome measure. 'n' signifies those participants who were evaluable for this measure at given time points.||participants|||Number
829713|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Day 7 After Second Injection|TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 7 after second injection for fingers that received 2 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Day 7 after second injection|FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.||degrees|Participants|Full Range|Median
829714|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Day 1 After Second Injection|TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 1 after second injection for fingers that received 2 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Day 1 after second injection|FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.||degrees|Participants|Full Range|Median
829715|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Day 30 After First Injection|TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 30 after first injection for fingers that received 1 injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Day 30 after first injection|FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.||degrees|Participants|Full Range|Median
829716|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Day 7 After First Injection|TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 7 after first injection for fingers that received 1 injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Day 7 after first injection|FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.||degrees|Participants|Full Range|Median
829717|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Day 1 After First Injection|TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 1 after first injection for fingers that received 1 injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Day 1 after first injection|FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.||degrees|Participants|Full Range|Median
829718|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Baseline for Fourth Injection|TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. Baseline value for fourth injection was the TPED value taken closest and prior to the administration of fourth injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Baseline for fourth injection|FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.||degrees|Participants|Full Range|Median
829719|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Baseline for Third Injection|TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. Baseline value for third injection was the TPED value taken closest and prior to the administration of third injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Baseline for third injection|FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N’ (number of participants analyzed) includes total number of participants in FAS, however actual ‘N’ for this outcome is unknown as these data were not calculated as per planned analysis.||degrees|Participants|Full Range|Median
829746|NCT01229735|Secondary|Median Percent Reduction in the Weekly Partial Onset Seizure (POS) Frequency From Baseline During the Total Treatment Period From Baseline to Week 52|Reduction from baseline was defined as baseline value minus post-baseline value and therefore is the negative of the change from baseline value.|From Baseline to Week 52|The Full Analysis Set (FAS) consists of all subjects in the Safety Set (SS) who returned at least 1 postbaseline seizure diary.||percent reduction||Inter-Quartile Range|Median
829720|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Baseline for Second Injection|TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. Baseline value for second injection was the TPED value taken closest and prior to the administration of second injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Baseline for second injection|FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. ‘N’ (number of participants analyzed) includes total number of participants in FAS, however actual ‘N’ for this outcome is unknown as these data were not calculated as per planned analysis.||degrees|Participants|Full Range|Median
829721|NCT01229436|Secondary|Number of Days as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire|Dupuytren's HCRU is a questionnaire used to assess healthcare usage in participants. Participants answered how many days since their last visit they 1) were hospitalized, 2) were in nursing home, 3) required aids/devices to assist in their daily functioning.|Baseline for cycle 1, 2, 3, 4, 5; C1D7, C1D30, C2D7, C2D30, C3D7, C3D30, C4D7, C4D30, C5D7, C5D30; Follow-up Day 90, 180 after last injection|FAS population. ‘Number of participants’ analyzed signifies those participants who were evaluable for this outcome measure. 'n' signifies those participants who were evaluable for this measure at given time points. Data for number of days was not analyzed for participants who responded that they did not perform the event.||days||Full Range|Median
829722|NCT01229436|Secondary|Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire|Dupuytren's HCRU is a questionnaire used to assess healthcare usage in participants. Participants answered how many times since their last visit they 1) had seen any doctor, 2) used any services (including physical or hand therapy, occupational therapy, home health care therapy), 3) were treated in emergency room, 4) had outpatient/day-case surgery, 5) were hospitalized, 6) had diagnostic/therapeutic procedures or tests performed.|Baseline for cycle 1, 2, 3, 4, 5; C1D7, C1D30, C2D7, C2D30, C3D7, C3D30, C4D7, C4D30, C5D7, C5D30; Follow-up Day 90, 180 after last injection|FAS population. 'Number of participants' analyzed signifies those participants who were evaluable for this outcome measure. 'n' signifies those participants who were evaluable for this measure at given time points. Data for number of events was not analyzed for participants who responded that they did not perform the event.||events||Full Range|Median
829723|NCT01229436|Secondary|Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire|Dupuytren's HCRU is a questionnaire used to assess healthcare usage in participants. Participants answered whether or not since their last visit they 1) had seen any doctor, 2) used any services (including physical or hand therapy, occupational therapy, home health care therapy), 3) were treated in emergency room, 4) had outpatient/day-case surgery, 5) were hospitalized, 6) had diagnostic/therapeutic procedures or tests performed, 7) were admitted in nursing home, 8) required aids/devices to assist in their daily functioning.|Baseline for cycle 1, 2, 3, 4, 5; C1D7, C1D30, C2D7, C2D30, C3D7, C3D30, C4D7, C4D30, C5D7, C5D30; Follow-up Day 90, 180 after last injection|FAS: participants who received >= 1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'n' signifies those participants who were evaluable for this measure at given time points.||participants|||Number
829724|NCT01229436|Secondary|Hand Functionality: Unite Rhumatologique Des Affections de la Main (URAM) Scale Total Score|URAM:9-item questionnaire used to assess daily hand functionality.Participants rated their ability to perform following hand functionalities on 0 to 5 scale(0=without difficulty,5=impossible):1)washing themselves with flannel, keeping hand flat,2)washing face,3)holding bottle in one hand,4)shaking someone's hand,5)stroking/caressing someone,6)clapping,7)spreading out fingers, 8)leaning on hand,9)picking up small objects with thumb and index finger.URAM total score=sum of 9 items.Total score range=0 to 45,where higher score= higher difficulty in daily hand functionality.For each cycle, baseline value=pre-injection value reported at that cycle. For follow-up on Day 90,180 after last injection, baseline value (follow-up baseline)=pre-injection value reported at cycle 1. If response was provided to less than or equal to 4 items,URAM total score was considered missing. If response was provided to >=5 items, then average score of answered questions was imputed response to missing questions.|Baseline for cycle 1, 2, 3, 4, 5; C1D30, C2D30, C3D30, C4D30, C5D30; Follow-up Day 90, 180 after last injection|FAS population. 'Number of participants' analyzed signifies those participants who were evaluable for this outcome measure. 'n' signifies those participants who were evaluable for this measure at given time points.||units on a scale||Full Range|Median
829725|NCT01229436|Secondary|Time to Recovery|Time to recovery of normal activities was defined as median number of days between the initial injection date and the date on which participant recovered to normal activities, assessed after first, second and third injection for joints that received 1 through 3 injections. If a participant did not achieve recovery to normal activities, the participant's time to recovery was defined as the median number of days between the initial injection date and the date of the participant's the last daily diary recording within the cycle.|Up to Day 30 after first, second and third injection|FAS population. 'Number of participants' analyzed signifies those participants who were evaluable for this outcome measure. 'n' signifies those participants who were evaluable for this measure at given time points.||days||95% Confidence Interval|Median
829726|NCT01229436|Secondary|Number of Days Assessed on Dupuytren’s Treatment Assessment Daily Diary Questionnaire|Dupuytren's daily diary questionnaire assessed number of days during a cycle when 1) participant was absent or sick due to treatment, 2) the work hours were reduced, 3) the job duties were modified, 4) participant was unable to participate in hobbies and 5) participant wore a splint (for participants who were fitted for a splint).|C1D1 to C1D30, C2D1 to C2D30, C3D1 to C3D30, C4D1 to C4D30, C5D1 to C5D30|FAS population. 'Number of participants' analyzed signifies those participants who were evaluable for this outcome measure. 'n' signifies those participants who were evaluable for this measure at given time points.||days||Full Range|Median
829727|NCT01229436|Secondary|Number of Days of Concomitant Pain Medication Usage|Amount of concomitant pain medication was assessed as the number of days participants used pain medication during the study.|Screening up to Day 180 after last injection|Safety set included all participants who received at least 1 injection of Xiapex. 'Number of participants' analyzed signifies those participants who were evaluable for this outcome measure.||days||Full Range|Median
829729|NCT01229436|Other Pre-specified|Number of Participants With Laboratory Abnormalities|Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen, creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid albumin, total protein); urinalysis (decimal logarithm of reciprocal of hydrogen ion activity [pH], glucose, protein, blood, ketones, microscopy[if urine tested positive for blood or protein]).|Screening up to Day 180 after last injection|Safety set included all participants who received at least 1 injection of Xiapex.||participants|||Number
829730|NCT01229436|Other Pre-specified|Number of Participants With Clinically Significant Change From Baseline in Vital Signs|Following parameters were analyzed for examination of vital signs: systolic and diastolic blood pressure, respiratory rate, radial pulse and body temperature.|Screening up to Day 180 after last injection|Safety set included all participants who received at least 1 injection of Xiapex.||participants|||Number
829731|NCT01229436|Secondary|Number of Participants With Type of Concomitant Pain Medication Used|Number of participants who took different types of analgesic medications, including acetylsalicylic acid, other analgesics (any other analgesic besides those mentioned, as approved by the investigator), aporex, codis, dihydrocodeine, fentanyl, galenic/paracetamol/codeine/, hot coldrex, metamizole, morphine, oxycodone, panadeine CO (combination of paracetamol and codeine phosphate), paracetamol, paramol-118, pregabalin, solpadeine, tramadol, ultracet, to manage pain symptoms were reported. A single participant may be represented in more than 1 category.|Screening up to Day 180 after last injection|Safety set included all participants who received at least 1 injection of Xiapex.||participants|||Number
829732|NCT01229436|Secondary|Physician Global Assessment of Treatment Satisfaction and Disease Severity|Physician global assessment questionnaire assessed severity of the contracture at baseline, post-injection and TS, improvement from baseline in the treated contracture at post-injection only. Physician’s rated disease severity as normal (no contracture), mild, moderate or severe. Overall satisfaction was rated as very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied or very dissatisfied. Physicians rated participant's improvement in disease severity relative to baseline as very much improved, much improved, minimally improved, no change, minimally worse, much worse or very much worse.|Baseline for cycle 1, 2, 3, 4, 5; cycle 1 Day 30 (C1D30), C2D30, C3D30, C4D30, C5D30; Follow-up (FU) Day 90, 180 after last injection|FAS: participants who received >= 1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'n' signifies those participants who were evaluable for this measure at given time points.||participants|||Number
829733|NCT01229436|Secondary|Participant Global Assessment of Treatment Satisfaction and Disease Severity|Participant global assessment questionnaire assessed severity of the contracture at baseline, post-injection and treatment satisfaction (TS), improvement from baseline in the treated contracture at post-injection only. Participants rated disease severity as normal (no contracture), mild, moderate or severe. Overall satisfaction was rated as very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied or very dissatisfied. Participants rated their improvement in disease severity relative to baseline on a 11-point scale ranging from 0 percent (%) = no improvement to 100% = total recovery, with 10 % increment between each point. Results are reported for number of participants in each category for disease severity, TS and improvement.|Baseline for cycle 1, 2, 3, 4, 5; Cycle 1 Day 30 (C1D30), C2D30, C3D30, C4D30, C5D30; Follow-up (FU) Day 90, 180 after last injection|FAS: participants who received >= 1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'n' signifies those participants who were evaluable for this measure at given time points.||participants|||Number
829734|NCT01229436|Secondary|Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints|Finger goniometry was used to measure the angles of extension and flexion of MP and PIP joints. ROM was measured as the difference between the angle of flexion and the angle of extension of the joint. For each injection, baseline value was the ROM value taken closest and prior to administration of that particular injection. For follow-up on Day 90 and 180 after last injection, baseline value (follow-up baseline) was the ROM value taken closest and prior to administration of first injection in that joint. ROM was reported at Day 1, 7 and 30 after each injection for joints that received 1 through 3 injections and at Day 90 and 180 after the last injection, where last injection was a maximum up to third injection for a joint. 'Number of joints analyzed' signifies total number of MP and PIP joints analyzed for this outcome measure and 'n' signifies number of joints evaluable for this measure at given time points for the mentioned joint.|Baseline for first, second, third injection; Day 1, 7, 30 after first, second, third injection; Follow-up Day 90, 180 after last injection|FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.||degrees|Participants|Full Range|Median
829735|NCT01229436|Secondary|Change From Baseline in Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints at Day 1, 7 and 30 After First, Second and Third Injection, Day 90 and 180 After Last Injection|PED was measured in MP and PIP joints using finger goniometry. Passive extension=angle of the joint (MP or PIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. For each injection, baseline value was the PED value taken closest and prior to administration of that particular injection. For follow-up on Day 90 and 180 after last injection, baseline value (follow-up baseline) was the PED value taken closest and prior to administration of first injection in that joint. Change in PED was reported at Day 1, 7 and 30 after each injection for joints that received 1 through 3 injections and at Day 90 and 180 after the last injection, where last injection was a maximum up to third injection for a joint. 'Number of joints analyzed' signifies total number of MP and PIP joints analyzed for this outcome measure and 'n' signifies number of joints evaluable for this measure at given time points for the mentioned joint.|Baseline for first, second, third injection; Day 1, 7, 30 after first, second, third injection; Follow-up Day 90, 180 after last injection|FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.||degrees|Participants|Full Range|Median
829736|NCT01229436|Secondary|Change From Baseline in Total Passive Extension Deficit (TPED) at Day 1, 7 and 30 After First, Second, Third and Fourth Injection, Day 90 and 180 After Last Injection|TPED was defined as sum of PED in MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. For each injection, baseline value was TPED value taken closest and prior to administration of that particular injection. Baseline value after first injection was also considered as baseline for follow-up on Day 90, 180 after last injection (follow-up baseline). Change in TPED was reported at Day 1, 7 and 30 after each injection for fingers that received 1 through 4 injections and at Day 90, 180 after last injection, where last injection was a maximum up to fourth injection for a finger. Results are not reported for fifth injection as no finger received 5 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Baseline for first, second, third, fourth injection; Day 1, 7, 30 after first, second, third, fourth injection; Follow-up Day 90, 180 after last injection|FAS population. 'N' (number of participants analyzed) includes total number of participants in FAS,however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis. Here, 'n' signifies number of fingers/joints evaluable for this outcome measure at given time points.||degrees|Participants|Full Range|Median
829737|NCT01229436|Secondary|Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints|PED was measured in MP and PIP joints using finger goniometry. Passive extension=angle of the joint (MP or PIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. For each injection, baseline value was the PED value taken closest and prior to administration of that particular injection. For follow-up on Day 90 and 180 after last injection, baseline value (follow-up baseline) was the PED value taken closest and prior to administration of first injection in that joint. PED was reported at Day 1, 7 and 30 after each injection for joints that received 1 through 3 injections and at Day 90 and 180 after the last injection, where last injection was a maximum up to third injection for a joint. 'Number of joints analyzed' signifies total number of MP and PIP joints analyzed for this outcome measure and 'n' signifies number of joints evaluable for this measure at given time points for the mentioned joint.|Baseline for first, second, third injection; Day 1, 7, 30 after first, second, third injection; Follow-up: Day 90, 180 after last injection|FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.||degrees|Participants|Full Range|Median
829738|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Baseline for First Injection|TPED was defined as the sum of passive extension deficits (PED) in the MP, PIP and distal interphalangeal (DIP) joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. Baseline value for first injection was the TPED value taken closest and prior to the administration of first injection. Baseline value after first injection was also considered as baseline for follow-up on Day 90, 180 after last injection (follow-up baseline). 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Baseline for first injection|Full analysis set(FAS):participants who received at least (>=)1 injection of Xiapex,had >=1 post-injection efficacy assessment(goniometric/participant-reported). 'N’(number of participants analyzed) includes total number of participants in FAS, however actual ‘N’ for this outcome is unknown as these data were not calculated as per planned analysis.||degrees|Participants|Full Range|Median
829739|NCT01229462|Primary|Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye at Week 4|Intraocular pressure (IOP) was measured in the study eye at baseline and Week 4. IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement).|Baseline, Week 4|Intent-to-treat population consisted of all randomized participants.||mm Hg||Standard Deviation|Mean
829740|NCT01229527|Secondary|Patient's Satisfaction|The degree of satisfaction about the quality of sedation was measured with VAS (Visual Analog Scale) where 0 means no satisfaction and 100 means maximum satisfaction.|After the end of colonoscopy (when patients were completely awake) and 24 h after the procedure via telephone|||units on a scale||Standard Deviation|Mean
829741|NCT01229527|Primary|Discharge Time, the Time to Reach a Modified Aldrete Score ≥18|Ten key parameters (Activity, Respiration, Circulation, Consciousness, O2 Saturation, Dressing, Pain, Ambulation, Fasting-feeding, Urine Output)are included in the Modified Aldrete Score. The maximum and minimum score for each parameter is respectively 2 and 0. The maximum total score is 20 and patient can be discharged when the total score is ≥18.|> 0 minutes|||minutes||Inter-Quartile Range|Median
829742|NCT01229722|Primary|Pill Count|During the clinic visits ever 3 weeks over the course of the study, participants will be asked to bring all their pill bottles and count the contents of each bottle with assistance from the study coordinator. This count will be compared with the refill history for that patient from the pharmacy in order to get a sense of how many pills they have taken.|every 3 weeks, for the 6 month duration of the third user study, from October 2011 through March 2012||||||
829743|NCT01229722|Primary|Self-Report|During the clinic visits ever 3 weeks over the course of the study, participants will be asked to recall what pills they took and what they missed.|every 3 weeks, for the 6 month duration of the third user study, from October 2011 through March 2012||||||
829744|NCT01229722|Primary|Adherence to Anti-retroviral Therapy|MEMS pill caps or boxes will be used to monitor adherence. Each participant will place the drug containing the protease inhibitor, or, if no such drug is being taken, the drug with the highest dosing frequency, inside of a MEMS device, which automatically records each time the pillbox was opened. Participants will bring this to the clinic during their regularly scheduled visits, and those daily measurements will be downloaded to a clinic machine.|daily, for the 6 month duration of the third user study, from October 2011 through March 2012|||percentage adherence||Standard Deviation|Mean
829745|NCT01229735|Secondary|Responders Defined as Number of Subjects With at Least 50 % Reduction in the Weekly POS Frequency From Baseline During the Total Treatment Period From Baseline to Week 52||From Baseline to Week 52|The Full Analysis Set (FAS) consists of all subjects in the SS who returned at least 1 postbaseline seizure diary.||responders|||Number
829747|NCT01229735|Secondary|Time From the First Study Treatment Intake to Drug Discontinuation Due to Adverse Event (AE)||From Baseline to Week 52|The Safety Set (SS) consists of all subjects who were randomized and received at least 1 (partial) dose of study medication.||month||Inter-Quartile Range|Median
829748|NCT01229735|Secondary|Number of Subjects With at Least One Adverse Event Reported During the Trial Period From Baseline to Week 52||From Baseline to Week 52|The Safety Set (SS) consists of all subjects who were randomized and received at least 1 (partial) dose of study medication.||Participants|||Number
829749|NCT01229735|Primary|Percentage of Subjects Continuing the Allocated Investigational Treatment From the First Study Treatment Intake to Week 52, After the Beginning of Investigational Treatment With Levetiracetam Compared to Topiramate||From Baseline to Week 52|The Full Analysis Set (FAS) consisted of all subjects in the Safety Set who returned at least 1 post-baseline seizure diary.||percentage of subjects|||Number
829750|NCT01229891|Secondary|Serum High Density Lipoprotein (HDL)||12-week|||mg/dL||Standard Deviation|Mean
829751|NCT01229891|Secondary|Serum Low Density Lipoprotein (LDL)||12-week|||mg/dL||Standard Deviation|Mean
829752|NCT01229891|Secondary|Serum Total Cholesterol (Tchol)||12-week|||mg/dL||Standard Deviation|Mean
829753|NCT01229891|Secondary|Serum Triglyceride (TG)||12-week|||mg/dL||Standard Deviation|Mean
829754|NCT01229891|Secondary|Hemoglobin A1c (HbA1c)||12-week|||percent||Standard Deviation|Mean
829755|NCT01229891|Secondary|Insulin|fasting serum insulin concentration|12-week|||mU/L||Standard Deviation|Mean
829756|NCT01229891|Secondary|Fasting Serum Glucose (FSG)||12-week|||mg/dL||Standard Deviation|Mean
829757|NCT01229891|Primary|Serum 25-hydroxyvitamin D||12-week|||nmol/L||Standard Deviation|Mean
829758|NCT01229943|Secondary|Overall Survival (OS)|Overall survival (OS) is defined as the time from study entry to death from any cause. The median OS was estimated using the Kaplan-Meier method.|From registration to time of death, assessed up to 3 years|||months||95% Confidence Interval|Median
829759|NCT01229943|Secondary|Overall Response Rate|The proportion of patients who respond (completely or partially) to each combination regimen will be estimated. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions.|Up to 3 years|||percentage of participants|||Number
829760|NCT01229943|Primary|Progression Free Survival|Progression Free Survival (PFS) was defined as the time from study entry until disease progression or death, whichever occurs first. The median PFS was estimated using the Kaplan-Meier method. Progression was assessed per RECIST criteria, and defined as at least a 20% increase in the sum of the longest diameters of target lesions (and an absolute increase of at least 0.5 cm) or the appearance of new lesions.|From study entry to the date of documented progression or death from any cause, up to 3 years|||months||95% Confidence Interval|Median
829761|NCT01230021|Secondary|Physical Examination (Evaluated as Normal/Abnormal)||From day 0 to day 30|Safety analysis population including all 6 children exposed to FXIII. All 6 children were exposed to one dose of trial product.||participants|||Number
829762|NCT01230021|Secondary|Vital Signs - Blood Pressure (Systolic and Diastolic)||Day 0 and day 30|Safety analysis population including all 6 children exposed to FXIII. All 6 children were exposed to one dose of trial product.||mmHg||Standard Deviation|Mean
829763|NCT01230021|Secondary|Vital Signs - Pulse||Day 0 and day 30|Safety analysis population including all 6 children exposed to FXIII. All 6 children were exposed to one dose of trial product.||beats/minute||Standard Deviation|Mean
829764|NCT01230021|Secondary|Clot Solubility Test (Evaluated as Normal/Abnormal)|Blood samples for clot solubility drawn at each visit (1 hour before and after dose administration). A clot solubility assay was used to screen for FXIII deficiency. The assay is based on the ability of urea to dissolve fibrin clots that have not undergone FXIII-induced stabilization. Normal blood clots generally remain stable for 24 hours or more, while clots in which fibrin molecules have not been cross-linked are soluble within minutes. The outcome of the test is normal (FXIII present; a clot is observed in the test tube) or abnormal (FXIII absent or very low level; no clot in test tube).|Day 0 and day 30|Safety analysis population including all 6 children exposed to FXIII. All 6 children were exposed to one dose of trial product.||participants|||Number
829765|NCT01230021|Secondary|Coagulation Related Parameters - Prothrombin Time (PT) (Seconds)||Day 0 and day 30|Safety analysis population including all 6 children exposed to FXIII. All 6 children were exposed to one dose of trial product.||Sec||Standard Deviation|Mean
829766|NCT01230021|Secondary|Coagulation Related Parameters - Activated Partial Thromboplastin Time (aPTT, Seconds)||Day 0 and day 30|Safety analysis population including all 6 children exposed to FXIII. All 6 children were exposed to one dose of trial product.||Sec||Standard Deviation|Mean
829767|NCT01230021|Secondary|Coagulation Related Parameters - Fibrinogen||Day 0 and at day 30|Safety analysis population including all 6 children exposed to FXIII. All 6 children were exposed to one dose of trial product.||g/L||Standard Deviation|Mean
829768|NCT01230021|Secondary|Percentage of Subjects With Development of Anti-rFXIII Antibodies, Including Inhibitors (Neutralising Antibodies Against Factor XIII)||At screening and day 30|Safety analysis population including all 6 children exposed to FXIII. All 6 children were exposed to one dose of trial product.||percentage of subjects|||Number
829769|NCT01230021|Secondary|Percentage of Subjects With One or More Serious Adverse Events (SAEs)||From day 0 to day 30|Safety analysis population including all 6 children exposed to FXIII. All 6 children were exposed to one dose of trial product.||percentage of subjects|||Number
829770|NCT01230021|Secondary|Percentage of Subjects With One or More Adverse Events (AEs) Recorded||From day 0 to day 30|Safety analysis population including all 6 children exposed to FXIII. All 6 children were exposed to one dose of trial product.||percentage (%) of subjects|||Number
829771|NCT01230021|Secondary|Volume of Distribution at Steady State (Vss)|Volume of distribution at steady state (Vss) is the theoretical volume that the total amount of administered drug would have to occupy (if it were uniformly distributed), to provide the same concentration as it is in blood plasma at steady state. Steady state is achieved when all variables are constant in spite of ongoing processes.|At steady state|The full analysis set including all 6 children exposed to FXIII. All 6 children were exposed to one dose of trial product.||mL/kg||Standard Deviation|Mean
829772|NCT01230021|Secondary|Total Plasma Clearance (CL)|The total plasma clearance is a measure of the elimination of a drug from the body. Drugs are excreted primarily by the kidneys into the urine. Clearance is calculated as ‘CL=Dose / AUC0-30 days’).|From day 0 to day 30|The full analysis set including all 6 children exposed to FXIII. All 6 children were exposed to one dose of trial product.||mL/h/kg||Standard Deviation|Mean
829773|NCT01230021|Secondary|Mean Residence Time (MRT)|The mean residence time (MRT) of a drug in the body and related functions are derived for drugs which are intravenously administered.|From day 0 to day 30|The full analysis set including all 6 children exposed to FXIII. All 6 children were exposed to one dose of trial product.||hours||Standard Deviation|Mean
829774|NCT01230021|Secondary|Terminal Half-life (t½)|Time point when half of the maximum plasma concentration is reached.|From day 0 to day 30|The full analysis set including all 6 children exposed to FXIII. All 6 children were exposed to one dose of trial product.||hours||Full Range|Mean
829775|NCT01230021|Secondary|Maximum Plasma Concentration (Cmax) for FXIII|Maximum plasma concentration of the drug reached.|At pre-dose, 30 minutes, 24 hours, 7, 14, 21 and 30 days after dosing|The full analysis set including all 6 children exposed to FXIII. All 6 children were exposed to one dose of trial product.||U/mL||Standard Deviation|Mean
829776|NCT01230021|Secondary|Area Under the Concentration vs. Time Curve (AUC0-∞)|A measure of exposure.|From day 0 to day 30|The full analysis set including all 6 children exposed to FXIII. All 6 children were exposed to one dose of trial product.||IU*h/mL||Standard Deviation|Mean
829777|NCT01230021|Primary|Area Under the Concentration vs. Time Curve (AUC)|A measure of the exposure. Blood samples for the PK assessment were drawn pre-dose and up to 30 days after dosing. The PK of FXIII in children was assessed after a single i.v. dose of rFXIII 35 IU/kg.|At pre-dose, 30 minutes, 24 hours, 7, 14, 21 and 30 days after dosing|The full analysis set including all 6 children exposed to FXIII. All 6 children were exposed to one dose of trial product.||IU*h/mL||Standard Deviation|Mean
829778|NCT01230060|Primary|Visual Acuity|Number of participants achieving best corrected visual acuity (BCVA) of 20/40 or better following cataract extraction and intraocular lens implantation.|120-180 days (visit 4)|All non missing implanted eyes, consistent set||Participants|||Number
829779|NCT01230177|Primary|Change in Disease Activity Score of 28 Joints (DAS28: 4/Erythrocyte Sedimentation Rate [ESR])|"DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = remission.
DAS28-3 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour). Total score range: 0-9.4, higher score=more disease activity. DAS28-3 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (ESR) <2.6 = remission."|12 weeks|||percent change||Standard Deviation|Mean
829780|NCT01230177|Secondary|Physician's Assessment of Clinical Effect of Etanercept on the Symptoms of Rheumatoid Arthritis and Change in Laboratory Values|"On the basis of how well the clinical symptoms of rheumatoid arthritis were controlled at baseline, the physician assessed the clinical effect of etanercept in two grades: effective or ineffective. To assess the clinical efficacy of etanercept, the degrees of the symptoms of rheumatoid arthritis and laboratory test values were compared between at baseline and at the 12th week of the investigation."|12 weeks|The efficacy analysis population consisted of the participants in whom the change in DAS28 (4/ESR and 3/ESR) was calculated. No descriptive statistic on the change in DAS28 (4/ESR and 3/ESR) was calculated due to a very small number of participants (n = 3).||participants|||Number
829781|NCT01230177|Secondary|Physician's Assessment of Clinical Effect of Etanercept on the Symptoms of Rheumatoid Arthritis and Change in Laboratory Values|"On the basis of how well the clinical symptoms of rheumatoid arthritis were controlled at baseline, the physician assessed the clinical effect of etanercept in two grades: effective or ineffective. To assess the clinical efficacy of etanercept, the degrees of the symptoms of rheumatoid arthritis and laboratory test values were compared between at baseline and at the 12th week of the investigation."|12 weeks|The efficacy analysis population consisted of the participants in whom the change in DAS28 (4/ESR and 3/ESR) was calculated. No descriptive statistic on the change in DAS28 (4/ESR and 3/ESR) was calculated due to a very small number of participants (n = 3).||participants|||Number
829782|NCT01230177|Primary|Disease Activity Score of 28 Joints (DAS28: 4/Erythrocyte Sedimentation Rate [ESR])|"DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = remission.
DAS28-3 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour). Total score range: 0-9.4, higher score=more disease activity. DAS28-3 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (ESR) <2.6 = remission."|12 weeks|||Score||Standard Deviation|Mean
829783|NCT01230177|Primary|Number of Participants With Treatment Related Adverse Events|Adverse events are defined as any unfavorable events, including clinically significant abnormal changes in laboratory test values, which develop in participants after the administration of etanercept regardless of the causal relationship to etanercept. The causal relationship between an adverse event and etanercept was evaluated by the sponsor.|12 weeks|The safety analysis population consisted of the participants in whom the regimen of etanercept was changed from 10 mg twice weekly to 25 mg once weekly for the treatment of rheumatoid arthritis.||participants|||Number
829784|NCT01230307|Secondary|Vitamin D Genomics|Genotyped for the restricted fragment length polymorphism at the BsmI site. In addition CYP2R1, CYP27B1, CYP24 will also be genotyped.|Baseline|Because enrollment was less than 30% of original goal (6 vs 4 patients) and therefore would not have scientific validity, in addition there is significant time and costs associated with this measurement which would result in data that would lead to no conclusions, this outcome was not analyzed.|||||
829785|NCT01230307|Secondary|Quality of Life Measured by Kansas City Cardiomyopathy Questionnaire|Kansas City Cardiomyopathy Questionnaire for quality of life is measured on a scale of 0 - 100, with 100 being best.|6 months|Because enrollment was less than 30% of original goal (6 vs 4 patients) and therefore would not have scientific validity and no conclusions could be determined, this outcome was not analyzed.|||||
829787|NCT01230307|Primary|Biomarkers|Biomarkers - C-reactive protein (CRP), interleukin-6 (IL-6), tumor necrosis factor-a (TNF-a), propeptide procollagen type I, plasma procollagen III, matrix metalloproteinase 2 (MMP-2), MMP-9 and tissue inhibitor of matrix metalloproteinases-1 (TIMP-1).|6 months|Because enrollment was less than 30% of original goal (6 vs 4 subjects) and therefore would not have scientific validity and would be a waste of financial resources, this outcome was not analyzed.|||||
829788|NCT01230424|Secondary|Change in Time to Complete 5 Chair Stands.|Change in time (seconds) to complete 5 chair stands. Missing data were imputed.|Baseline to 2 years|All individuals were included in analysis, which was performed on multiply imputed data.||seconds||95% Confidence Interval|Mean
829789|NCT01230424|Secondary|Change in Time to Complete a Twenty-meter Walk.|Change in time (seconds) to complete a twenty-meter walk. Missing data were imputed.|Baseline to 2 years|All individuals were included in analysis, which was performed on multiply imputed data.||seconds||95% Confidence Interval|Mean
829790|NCT01230424|Secondary|Change in Patient's Global Assessment (Visual Analogue Scale).|"The response to the question, Considering all the ways your knee affects you, how much pain are you having today?, was measured and the change in the scoring was evaluated. The Patient's Global Assessment (PGA) is measured on a scale of 0 to 100 millimeters. Higher scores represent a higher level of disease activity or a worse global health. Missing data were imputed."|Baseline to 2 years|All individuals were included in analysis, which was performed on multiply imputed data.||mm||95% Confidence Interval|Mean
829791|NCT01230424|Secondary|Change in Knee Stiffness During the Past 48 Hours From the WOMAC LK3.1 Stiffness Score Questionnaire.|"Stiffness subscale score was calculated from patient's responses on the Western Ontario and McMaster Universities Osteoarthritis Index Likert-type 3.1 Questionnaire. The questionnaire includes 24 items divided into 3 subscales, Pain, Stiffness, Physical Function. Only the Stiffness subscale score was used for this outcome measure. The Stiffness subscale consists of two items, each ranging from 0 to 4, making the total Stiffness subscore 0 to 8. Higher scores represent higher levels of stiffness, whereas lower scores represent lower levels of stiffness.
Missing data were imputed."|Baseline to 2 years|All individuals were included in analysis, which was performed on multiply imputed data.||units on a scale||95% Confidence Interval|Mean
829792|NCT01230424|Secondary|Change in Function Severity During the Past 48 Hours From the WOMAC LK3.1 Function Score Questionnaire.|"Physical Function subscale score was calculated from patient's responses on the Western Ontario and McMaster Universities Osteoarthritis Index Likert-type 3.1 Questionnaire. The questionnaire includes 24 items divided into 3 subscales, Pain, Stiffness, Physical Function. Only the Physical Function subscale score was used for this outcome measure. The Physical Function subscale consists of 17 items, each ranging from 0 to 4, making the total Function subscore 0 to 68. Higher scores represent higher levels of difficulty performing daily activities, whereas lower scores represent lower levels of difficulty performing daily activities.
Missing data were imputed."|Baseline to 2 years|All individuals were included in analysis, which was performed on multiply imputed data.||units on a scale||95% Confidence Interval|Mean
829793|NCT01230424|Secondary|Change in Volumetric Cartilage Damage Index (CDI) Measured on Knee MRI in the Index Compartment (Compartment With the Most Damage).|Change in volumetric cartilage damage index (CDI) measured on knee MRI in the index compartment (compartment with the most damage). Missing data were imputed.|Baseline to 2 years|All individuals were included in analysis, which was performed on multiply imputed data.||mm^3||95% Confidence Interval|Mean
829794|NCT01230424|Secondary|Change in Area of Denudation Measured on Knee MRI in the Index Compartment (Compartment With the Most Damage).|Change in area of denudation measured on knee MRI in the index compartment (compartment with the most damage). Missing data were imputed.|Baseline to 2 years|All individuals were included in analysis, which was performed on multiply imputed data.||mm^2||95% Confidence Interval|Mean
829795|NCT01230424|Secondary|Change in Effusion Volume Measured on Knee MRI.|Change in effusion volume measured on knee MRI on the log scale. Missing data were imputed.|Baseline to 2 years|All individuals were included in analysis, which was performed on multiply imputed data.||log mm^3||95% Confidence Interval|Mean
829796|NCT01230424|Secondary|Change in Volume of Peri-articular Bone Marrow Lesions Measured on Knee MRI.|Change in volume of peri-articular bone marrow lesions measured on knee MRI on the log scale. Missing data were imputed.|Baseline to 2 years.|All individuals were included in analysis, which was performed on multiply imputed data.||log mm^3||95% Confidence Interval|Mean
829797|NCT01230424|Primary|Change in Knee Pain Severity During the Past 48 Hours From the WOMAC LK3.1 Pain Score Questionnaire.|"Pain subscale score was calculated from patient's responses on the Western Ontario and McMaster Universities Osteoarthritis Index Likert-type 3.1 Questionnaire. The questionnaire includes 24 items divided into 3 subscales, Pain, Stiffness, Physical Function. Only the Pain subscale score was used for this outcome measure. The Pain subscale consists of five items, each ranging from 0 to 4, making the total Pain subscore 0 to 20. Higher scores represent higher levels of pain, whereas lower scores represent lower levels of pain.
Missing data were imputed."|Baseline to 2 years|All individuals were included in analysis, which was performed on multiply imputed data.||units on a scale||95% Confidence Interval|Mean
829798|NCT01230424|Primary|Change in Mean Cartilage Thickness in the Index Compartment (Compartment With the Most Damage)|Mean cartilage thickness was measured on knee MRI (Philips Achieva X-Series 3.0 Tesla scanner). Missing data were imputed.|Baseline to 2 years|All individuals were included in analysis, which was performed on multiply imputed data.||mm||95% Confidence Interval|Mean
829799|NCT01230502|Primary|Modification of Diet in Renal Disease (MDRD) Estimation of Glomerular Filtration Rate (GFR)|"This outcome measure is used to determine if the reduction of calcineurin inhibitor immunosuppression leads to improved native kidney function. Native kidney function is assessed using the Modification of Diet in Renal Disease (MDRD) estimation of glomerular filtration rate (GFR) from serum or plasma creatinine samples at the reported time points.
Reference intervals include:
Healthy 18 years and up: 60-120 mL/min/1.73 sqm Chronic kidney disease: GFR < 60 mL/min/1.73 sqm Kidney failure: GFR < 15 mL/min/1.73 sqm"|12 months post enrollment/randomization|||mL/min/1.73 sqm||Standard Deviation|Mean
829827|NCT01230892|Primary|Number of Participants With Reduction of Thin-cap Fibroatheromas (TCFA) as Defined by VH-IVUS|Presence of thin-cap fibroatheroma as defined by virtual histology-intravascular ultrasound (VH-IVUS)|1 year|4 subjects either withdrew or were lost to follow-up and not included in analysis population. Additionally, one subject in the Atenolol arm was removed from analysis population due to IVUS occurring in the incorrect artery and one subject in the Nebivolol arm was removed due to the IVUS catheter malfunctioning.||participants|||Number
829800|NCT01230502|Primary|Modification of Diet in Renal Disease (MDRD) Estimation of Glomerular Filtration Rate (GFR)|"This outcome measure is used to determine if the reduction of calcineurin inhibitor immunosuppression leads to improved native kidney function. Native kidney function is assessed using the Modification of Diet in Renal Disease (MDRD) estimation of glomerular filtration rate (GFR) from serum or plasma creatinine samples at the reported time points.
Reference intervals include:
Healthy 18 years and up: 60-120 mL/min/1.73 sqm Chronic kidney disease: GFR < 60 mL/min/1.73 sqm Kidney failure: GFR < 15 mL/min/1.73 sqm"|6 months post enrollment/randomization|||mL/min/1.73 sqm||Standard Deviation|Mean
829801|NCT01230710|Secondary|Percentage of Participants With Disease Control|A participant with disease control was defined as a participant with either a complete response (CR), a partial response (PR), or stable disease (SD), as determined using RECIST v1.1. A CR was defined as the disappearance of all target lesions (TL). A PR was defined as at least a 30% decrease in the sum of the longest diameter of TLs taking as reference the Baseline sum longest diameter (SLD). SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest SLD since treatment started. For non-TLs, SD was defined as the persistence of 1 or more lesions. PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since treatment started or the unequivocal progression of existing non-TLs. A SLD for all TLs will be calculated and reported as the Baseline SLD. Tumor assessments were done by magnetic resonance imaging according to RECIST v1.1.|From the date of enrolment until the end of the study (up to 2 years, 6 months).|Full analysis set: All enrolled participants. The analysis only included 47 participants as data for 4 participants was not available.||Percentage of participants|||Number
829802|NCT01230710|Secondary|Percentage of Participants With a Complete Response (CR) or a Partial Response (PR)|A CR was defined as the disappearance of all target lesions. A PR was defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the Baseline sum longest diameter. All measurable lesions up to a maximum of 2 lesions per organ and 5 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. All other lesions (or sites of disease) should be identified as non-target lesions. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter. Tumor assessments were done by magnetic resonance imaging according to RECIST v1.1.|From the date of enrolment until the end of the study (up to 2 years, 6 months).|Full analysis set: All enrolled participants. The analysis only included 47 participants as data for 4 participants was not available.||Percentage of participants|||Number
829803|NCT01230710|Secondary|Overall Survival|Overall survival was defined as the time from the date of enrolment to the date of death from any cause.|From the date of enrolment until the end of the study (up to 2 years, 6 months).|Full analysis set: All enrolled participants.||Days||Inter-Quartile Range|Median
829804|NCT01230710|Secondary|Progression-free Survival (PFS)|PFS was defined as the time from the date of enrolment to the date of disease progression (PD) or death, whichever occurred first. Tumor assessments were done by magnetic resonance imaging according to RECIST v1.1. PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions (TL), taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-TLs. All measurable lesions up to a maximum of 2 lesions per organ and 5 lesions in total, representative of all involved organs, should be identified as TLs at Baseline. TLs should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all TLs will be calculated and reported as the Baseline sum longest diameter.|From the date of enrolment until the end of the study (up to 2 years, 6 months).|Full analysis set: All enrolled participants.||Days||95% Confidence Interval|Median
829805|NCT01230710|Primary|Percentage of Participants With Progression-free Survival at Week 52|A participant had progression-free survival if they did not have disease progression and were alive. Tumor assessments were done by magnetic resonance imaging according to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. Disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions. All measurable lesions up to a maximum of 2 lesions per organ and 5 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.|From the date of enrolment in the study until the date of disease progression or death from any cause (up to 2 years, 6 months).|Full analysis set: All enrolled participants.||Percentage of participants|||Number
829806|NCT01230749|Secondary|Change From Baseline to Day 29 in Body Weight|Difference is calculated as the change in body weight in Least Square Mean (LSM) from baseline to Day 29 of each treatment group (pioglitazone, JNJ-41443532 250 mg, JNJ-41443532 1000 mg, and placebo). The statistical analyses shows the treatment differences (ie, each study medication group minus placebo) in the LSM change.|From baseline to Day 29|Analyses included all participants who received at least 1 dose of JNJ-41443532 or placebo and had at least 1 pharmacodynamic assessment posttreatment.||Kilograms||Standard Error|Least Squares Mean
829807|NCT01230749|Secondary|Change From Baseline to Day 28 in Systemic Levels of C-Reactive Protein (CRP)|Difference is calculated as the geometric mean change in CRP from baseline to Day 28 of each treatment group (JNJ-41443532 250 mg, JNJ-41443532 1000 mg, and placebo). The statistical analyses shows the treatment differences (ie, each study medication group minus placebo) in the geometric mean change. CRP was not measured for pioglitazone group.|From baseline to Day 28|Analyses included all participants who received at least 1 dose of JNJ-41443532 or placebo and had at least 1 pharmacodynamic assessment posttreatment.||mg/dL||Standard Deviation|Geometric Mean
829860|NCT01233232|Secondary|Plasma Concentration of AZD5069 After 1 Hour of Dosing|At this visit, approximately 1 hour after dosing (at the clinic), a blood sample was collected for determination of drug concentration in plasma.|End of Treatment (Day 28), 1 hour after dosing|||nmol/L||Standard Deviation|Mean
829808|NCT01230749|Secondary|Change From Baseline to Day 28 in Systemic Levels of Interleukin 18 (IL-18)|Difference is calculated as the geometric mean change in IL-18 from baseline to Day 28 of each treatment group (JNJ-41443532 250 mg, JNJ-41443532 1000 mg, and placebo). The statistical analyses shows the treatment differences (ie, each study medication group minus placebo) in the geometric mean change. IL-18 was not measured for pioglitazone group. The unit of IL-18 is picograms per milliliter (pg/mL)|From baseline to Day 28|Analyses included all participants who received at least 1 dose of JNJ-41443532 or placebo and had at least 1 pharmacodynamic assessment posttreatment.||pg/mL||Standard Deviation|Geometric Mean
829809|NCT01230749|Secondary|Change From Baseline to Day 28 in Systemic Levels of Interleukin 6 (IL-6)|Difference is calculated as the geometric mean change in IL-6 from baseline to Day 28 of each treatment group (JNJ-41443532 250 mg, JNJ-41443532 1000 mg, and placebo). The statistical analyses shows the treatment differences (ie, each study medication group minus placebo) in the geometric mean change. IL-6 is a systemic inflammatory markers and is an independent predictors of insulin resistance and progression to type 2 diabetes mellitus. IL-6 was not measured for pioglitazone guoup. The unit of IL-6 is picograms per milliliter (pg/mL).|From baseline to Day 28|Analyses included all participants who received at least 1 dose of JNJ-41443532 or placebo and had at least 1 pharmacodynamic assessment posttreatment.||pg/mL||Standard Deviation|Geometric Mean
829810|NCT01230749|Secondary|Change From Baseline to Day 28 in Insulin Resistance|Difference is calculated as the change in insulin resistance in Least Square Mean (LSM) from baseline to Day 28 of each treatment group (pioglitazone, JNJ-41443532 250 mg, JNJ-41443532 1000 mg, and placebo). The statistical analyses shows the treatment differences (ie, each study medication group minus placebo) in the LSM change. Insuline sensitivity is measured by absolute change in Homeostasis Model Assessment of insulin resistance (HOMA-IR). Insulin sensitivity is HOMA-%S and HOMA-IR is the reciprocal of HOMA-%S. HOMA-IR calculated as: (Glucose [mg/dL]) multiplied by Insulin [pmol/L]) divided by (405 multiplied by 6.945). Lower value is better (signifies improvement relative to baseline).|From baseline to Day 28|Analyses included all participants who received at least 1 dose of JNJ-41443532 or placebo and had at least 1 pharmacodynamic assessment posttreatment. Two participants (1 in JNJ-41443532 250-mg group and 1 in Pioglitazone group) were excluded from the analysis because a blood sample for HOMA-IR was not collected on Day 28.||HOMA-IR score||Standard Error|Least Squares Mean
829811|NCT01230749|Secondary|Change From Baseline to Day 28 in Insulin Secretion|Difference is calculated as the change in insulin secretion in Least Square Mean (LSM) from baseline to Day 28 of each treatment group (pioglitazone, JNJ-41443532 250 mg, JNJ-41443532 1000 mg, and placebo). The statistical analyses shows the treatment differences (ie, each study medication group minus placebo) in the LSM change. Insulin secretion is measured by the absolute change in Homeostasis Model Assessment of steady state islet beta cell (HOMA-%B). HOMA-%B calculated as: (360 multiplied by Insulin [pmol/L]) divided by ([Glucose {mg/dL} minus 63] multiplied by 6.945). Higher value is better (signifies improvement relative to baseline).|From baseline to Day 28|Analyses included all participants who received at least 1 dose of JNJ-41443532 or placebo and had at least 1 pharmacodynamic assessment posttreatment. Two participants (1 in JNJ-41443532 250-mg group and 1 in Pioglitazone group) were excluded from the analysis because a blood sample for HOMA-%B was not collected on Day 28.||HOMA-B score||Standard Error|Least Squares Mean
829812|NCT01230749|Secondary|Change From Baseline to Day 28 in Fasting Plasma Glucose (FPG)|Difference is calculated as the change in FPG in Least Square Mean (LSM) from baseline to Day 28 of each treatment group (pioglitazone, JNJ-41443532 250 mg, JNJ-41443532 1000 mg, and placebo). The statistical analyses shows the treatment differences (ie, each study medication group minus placebo) in the LSM change.|From baseline to Day 28|Analyses included all participants who received at least 1 dose of JNJ-41443532 or placebo and had at least 1 pharmacodynamic assessment posttreatment. Two participants (1 in JNJ-41443532 250-mg group and 1 in Pioglitazone group) were excluded from the analysis because a blood sample for FPG was not collected on Day 28.||mg/dL||Standard Error|Least Squares Mean
829813|NCT01230749|Primary|Change From Baseline (Day -1) to Day 28 in Twenty-Four-Hour Weighted Average Glucose (24-Hour WAG)|Difference is calculated as the change in 24-hour WAG in Least Square Mean (LSM) from baseline to Day 28 of each treatment group (pioglitazone, JNJ-41443532 250 mg, JNJ-41443532 1000 mg, and placebo). The statistical analyses shows the treatment differences (ie, each study medication group minus placebo) in the LSM change. 24-hour WAG is defined as the area under the plasma glucose concentration time curve over 0 to 24 hours, divided by 24.|From baseline (Day -1) to Day 28|Analyses included all participants who received at least 1 dose of JNJ-41443532 or placebo and had at least 1 pharmacodynamic assessment posttreatment.||mg/dL||Standard Error|Least Squares Mean
829814|NCT01230788|Secondary|Prednisone Effect|To correlate the effect of prednisone on CD20 expression using serial measurements of CD20 expression in leukemic blasts.|one month after treatment||||||
829815|NCT01230788|Secondary|Minimal Residual Disease|To perform serial minimal residual disease (MRD) measurements to provide an objective determination of the effectiveness of this therapy.|one month after treatment|The one subject was enrolled became a screen failure as she started a prohibited medication prior to going on study.|||||
829816|NCT01230788|Primary|Remission Induction Rate|To estimate the remission induction rate of the addition of rituximab to cytotoxic chemotherapy (prednisone/etoposide/ifosfamide) in patients with second relapse/refractory ALL.|one month|The one subject was enrolled became a screen failure as she started a prohibited medication prior to going on study.|||||
829817|NCT01230788|Primary|Toxicities of Rituximab|To describe the toxicities of rituximab in addition to prednisone, etoposide, and ifosfamide.|two months after treatment|The one subject was enrolled became a screen failure as she started a prohibited medication prior to going on study.|||||
829818|NCT01230788|Primary|4 Month Event Free Survival (EFS)|To estimate the 4 month EFS after therapy with rituximab and cytotoxic chemotherapy (prednisone/etoposide/ifosfamide) in patients with second relapse/refractory ALL.|one year after enrollment|The one subject was enrolled became a screen failure as she started a prohibited medication prior to going on study.|||||
829861|NCT01233232|Primary|Change From Baseline to End of Treatment for Total Protein (Urinalysis)|The change in total protein in urine is calculated as the End of Treatment value minus the Baseline value.|Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)|||g/L||Standard Deviation|Mean
830366|NCT01235715|Primary|Number of Autologous Transfusion Units Over the Course of the Hospital Stay|Units of autologous transfusion for each patient over the course of the hospital stay (an average of 3 days) were recorded.|perioperatively|||units||Standard Error|Mean
829819|NCT01230814|Secondary|Efficacy of Monthly Periodic Presumptive Treatment (PPT) Using Metronidazole With Miconazole Intravaginal Suppositories Versus Matching Placebo Nightly for Five Nights Each Month for Preventing BV by Clinical Criteria (Amsel’s Criteria).|Percentage of follow-up visits (Months 2, 4, 6, 8, 10, 12) positive for BV by clinical criteria (Amsel's criteria).|Months 2, 4, 6, 8, 10, and 12.|Intention to treat population which consisted of all women who were randomized and had at least one follow-up visit. Two women in the metronidazole with miconazole arm did not return after enrollment.||percentage of follow-up visits|Participants|95% Confidence Interval|Number
829820|NCT01230814|Secondary|Efficacy of Monthly Periodic Presumptive Treatment (PPT) Using Metronidazole With Miconazole Intravaginal Suppositories Versus Placebo for Preventing Any Vaginal Infection (a Combined Endpoint Including BV, VVC, and Trichomonas Vaginalis Infection).|Percentage of follow-up visits (Months 2, 4, 6, 8, 10, 12) positive for any of three vaginal infections (BV, VVC, Trichomonas vaginalis infection).|Months 2, 4, 6, 8, 10, and 12.|Intention to treat population which consisted of all women who were randomized and had at least one follow-up visit. Two women in the metronidazole with miconazole arm did not return after enrollment.||percentage of follow-up visits|Participants|95% Confidence Interval|Number
829821|NCT01230814|Primary|Efficacy of Monthly Periodic Presumptive Treatment (PPT) Using Metronidazole With Miconazole Intravaginal Suppositories Versus Matching Placebo Nightly for Five Nights Each Month for Preventing Bacterial Vaginosis (BV).|Percentage of follow-up visits (Months 2, 4, 6, 8, 10, 12) positive for BV as determined by applying standard microscopic scoring criteria (Nugent’s criteria) to vaginal Gram stained slides. BV is diagnosed when the score is greater than or equal to 7.|Months 2, 4, 6, 8, 10, and 12.|Intention to treat population which consisted of all women who were randomized and had at least one follow-up visit. Two women in the metronidazole with miconazole arm did not return after enrollment.||percentage of follow-up visits|Participants|95% Confidence Interval|Number
829822|NCT01230814|Primary|Efficacy of Monthly Periodic Presumptive Treatment (PPT) Using Metronidazole With Miconazole Intravaginal Suppositories Versus Matching Placebo Nightly for Five Nights Each Month for Preventing Vulvovaginal Candidiasis (VVC).|Percentage of follow-up visits (Months 2, 4, 6, 8, 10, 12) positive for VVC based on the presence of fungal elements (pseudohyphae, blastoconidia, or both) on vaginal saline wet mount plus a positive culture showing yeast on Sabouraud’s agar.|Months 2, 4, 6, 8, 10, and 12.|Intention to treat population which consisted of all women who were randomized and had at least one follow-up visit. Two women in the metronidazole with miconazole arm did not return after enrollment.||percentage of follow-up visits|Participants|95% Confidence Interval|Number
829823|NCT01230827|Secondary|Percentage of Participants Who Achieved Clinical Remission While on Medication for Juvenile Idiopathic Arthritis (JIA) at Week 48|Clinical remission while on medication for JIA is defined as inactive disease at each visit for a period of 6 months or more while on medication. Inactive disease is indicated by the presence of all of the following: no joints with active arthritis; no fever, rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to juvenile idiopathic arthritis; no active uveitis (eye disease), normal erythrocyte sedimentation rate or C-reactive protein; physician global assessment of disease activity indicating no active disease; and duration of morning stiffness less than 15 minutes.|Week 16 through Week 48|ITT population included all participants achieving ACR Ped 30 response who were randomized at Week 16.||Percentage of Participants|||Number
829824|NCT01230827|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 30 Response Who Had Inactive Disease at Week 48|Inactive disease is indicated by the presence of all of the following: no joints with active arthritis; no fever, rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to juvenile idiopathic arthritis; no active uveitis (eye disease), normal erythrocyte sedimentation rate or C-reactive protein; physician global assessment of disease activity indicating no active disease; and duration of morning stiffness less than 15 minutes.|Week 16 through Week 48|ITT population included all participants achieving ACR Ped 30 response who were randomized at Week 16.||Percentage of Participants|||Number
829825|NCT01230827|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 30 Response at Week 48|Percentage of participants with ACR 30 response at Week 48 was calculated as number of participants with ACR 30 response at Week 48 divided by number of participants randomized. ACR Ped 30 response was defined as the worsening from Week 16 by 30% or more in 3 of the 6 ACR Pediatric (Ped) Core Set Variables with no more than 1 of the 6 ACR Ped Core Set variables improving by more than 30% at the time of the flare. The 6 variables are: physicians global assessment of disease, participants/parent global assessment of overall well-being, number of active joints (defined as either swelling, or in absence of swelling, limited range of motion associated with pain on motion or tenderness), number of joints with limited range of motion, physical function by childhood health assessment questionnaire, and erythrocyte sedimentation rate.|Week 16 through Week 48|Intent-to-treat (ITT) population included all participants achieving American College of Rheumatology (ACR) Pediatric (Ped) 30 response who were randomized at Week 16.||Percentage of Participants|||Number
829826|NCT01230827|Primary|Percentage of Participants With American College of Rheumatology (ACR) 30 Response at Week 16 Who Did Not Experienced a Flare of Disease Through Week 48|Percentage of participants with American College of Rheumatology (ACR) Ped 30 responders at Week 16 who did not experience a flare of disease between Week 16 and Week 48 calculated as number of participants with response and who did not experience flare divided by number of participants randomized. Flare of disease was defined as the worsening from Week 16 by 30% or more in 3 of the 6 ACR Pediatric (Ped) Core Set Variables with no more than 1 of the 6 ACR Ped Core Set variables improving by more than 30% at the time of the flare. The 6 variables are: physicians global assessment of disease, participants/parent global assessment of overall well-being, number of active joints (defined as either swelling, or in absence of swelling, limited range of motion associated with pain on motion or tenderness), number of joints with limited range of motion, physical function by childhood health assessment questionnaire, and erythrocyte sedimentation rate.|Week 16 through Week 48|Intent-to-treat (ITT) population included all participants achieving American College of Rheumatology (ACR) Pediatric (Ped) 30 response who were randomized at Week 16.||Percentage of Participants|||Number
829862|NCT01233232|Primary|Number of Participants Who Developed High Transaminase Values (Clinical Chemistry)|High Transaminase Values are defined as a measurment of ALT (alanine aminotransferase) or AST (aspartate aminotransferase) greater than or equal to 3 times the upper limit of normal (ALT ULN = 36 IU/L, AST ULN = 33 IU/L).|Up to Follow-up Visit (3 to 18 days after End of Treatment [Day 28])|||Participants|||Number
829828|NCT01224171|Secondary|Number of Participants With Adverse Events (AEs)|"An AE was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, which did not necessarily have a causal relationship with the treatment. A serious adverse event (SAE) was any AE, occurring at any dose and regardless of causality that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was an important medical event based upon appropriate medical judgment that may have jeopardized the patient and may have required medical or surgical intervention to prevent 1 of the outcomes listed above, or any diagnosis of progressive multifocal leukoencephalopathy (PML).
Relationship to study drug administration was determined by the investigator responding yes or no to the question: Is there a reasonable possibility that the AE is associated with the study drug?"|From the date of first study drug administration to Week 22, through the 14 March 2012 database lock date. At the time of this database lock, 7 patients had completed Week 10 or early termination assessments but not Week 22 assessments.|Overall Safety Population||participants|||Number
829829|NCT01224171|Secondary|Percentage of Participants With Enhanced Clinical Response at Week 6 in the TNFα Antagonist Failure Subpopulation|"Enhanced clinical response is defined as a ≥ 100-point decrease in CDAI score from Baseline.
The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:
Number of liquid or soft stools each day for 7 days;
Abdominal pain (graded from 0-3 on severity) each day for 7 days;
General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;
Presence of complications;
Taking Lomotil or opiates for diarrhea;
Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);
Hematocrit of < 0.47 in men and < 0.42 in women;
Percent deviation from standard weight.
The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.
All participants who prematurely discontinued for any reason were considered as not achieving enhanced clinical response."|Baseline and Week 6|TNFα Antagonist Failure ITT Subpopulation||percentage of participants||95% Confidence Interval|Number
829830|NCT01224171|Secondary|Percentage of Participants With Sustained Clinical Remission in the Overall Population|"Sustained clinical remission is defined as a CDAI score ≤ 150 points at both Week 6 and Week 10. The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:
Number of liquid or soft stools each day for 7 days;
Abdominal pain (graded from 0-3 on severity) each day for 7 days;
General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;
Presence of complications;
Taking Lomotil or opiates for diarrhea;
Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);
Hematocrit of < 0.47 in men and < 0.42 in women;
Percentage deviation from standard weight.
The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.
All participants who prematurely discontinued for any reason were considered as not achieving sustained clinical remission."|Week 6 and Week 10|Overall ITT population||percentage of participants||95% Confidence Interval|Number
829831|NCT01224171|Secondary|Percentage of Participants With Sustained Clinical Remission in the TNFα Antagonist Failure Population|"Sustained clinical remission is defined as a CDAI score ≤ 150 points at both Week 6 and Week 10. The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:
Number of liquid or soft stools each day for 7 days;
Abdominal pain (graded from 0-3 on severity) each day for 7 days;
General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;
Presence of complications;
Taking Lomotil or opiates for diarrhea;
Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);
Hematocrit of < 0.47 in men and < 0.42 in women;
Percentage deviation from standard weight.
The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.
All participants who prematurely discontinued for any reason were considered as not achieving sustained clinical remission."|Week 6 and Week 10|TNFα Antagonist Failure ITT Subpopulation||percentage of participants||95% Confidence Interval|Number
829832|NCT01224171|Secondary|Percentage of Participants in Clinical Remission at Week 10 in the Overall Population|"Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤ 150 points.
The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:
Number of liquid or soft stools each day for 7 days;
Abdominal pain (graded from 0-3 on severity) each day for 7 days;
General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;
Presence of complications;
Taking Lomotil or opiates for diarrhea;
Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);
Hematocrit of < 0.47 in men and < 0.42 in women;
Percentage deviation from standard weight.
The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.
All participants who prematurely discontinued for any reason were considered as not achieving clinical remission."|Week 10|Overall ITT population||percentage of participants||95% Confidence Interval|Number
829833|NCT01224171|Secondary|Percentage of Participants in Clinical Remission at Week 10 in the TNFα Antagonist Failure Subpopulation|"Clinical remission is defined as a Crohn’s Disease Activity Index (CDAI) score ≤ 150 points.
The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:
Number of liquid or soft stools each day for 7 days;
Abdominal pain (graded from 0-3 on severity) each day for 7 days;
General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;
Presence of complications;
Taking Lomotil or opiates for diarrhea;
Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);
Hematocrit of < 0.47 in men and < 0.42 in women;
Percentage deviation from standard weight.
The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.
All participants who prematurely discontinued for any reason were considered as not achieving clinical remission."|Week 10|TNFα Antagonist Failure Intent-to-treat (ITT) Subpopulation||percentage of participants||95% Confidence Interval|Number
829863|NCT01233232|Primary|Change From Baseline to End of Treatment for FEV1 Post-bronchodilator (Lung Function Test)|The change in FEV1 Post-bronchodilator is calculated as the End of Treatment value minus the Baseline value.|Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)|||L||Standard Deviation|Mean
829834|NCT01224171|Secondary|Percentage of Participants in Clinical Remission at Week 6 in the Overall Population|"Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤ 150 points.
The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:
Number of liquid or soft stools each day for 7 days;
Abdominal pain (graded from 0-3 on severity) each day for 7 days;
General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;
Presence of complications;
Taking Lomotil or opiates for diarrhea;
Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);
Hematocrit of < 0.47 in men and < 0.42 in women;
Percentage deviation from standard weight.
The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.
All participants who prematurely discontinued for any reason were considered as not achieving clinical remission."|Week 6|Overall ITT population, consisting of all randomized participants who received any amount of blinded study drug.||percentage of participants||95% Confidence Interval|Number
829835|NCT01224171|Primary|Percentage of Participants in Clinical Remission in the Tumor Necrosis Factor Alpha (TNFα) Antagonist Failure Subpopulation|"Clinical remission is defined as a Crohn’s Disease Activity Index (CDAI) score ≤ 150 points.
The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:
Number of liquid or soft stools each day for 7 days;
Abdominal pain (graded from 0-3 on severity) each day for 7 days;
General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;
Presence of complications;
Taking Lomotil or opiates for diarrhea;
Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);
Hematocrit of < 0.47 in men and < 0.42 in women;
Percentage deviation from standard weight.
The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.
All participants who prematurely discontinued for any reason were considered as not achieving clinical remission."|Week 6|TNFα Antagonist Failure Intent-to-treat (ITT) subpopulation which consisted of all randomized participants who received any amount of blinded study drug who met the TNFα antagonist failure criterion.||percentage of participants||95% Confidence Interval|Number
829836|NCT01224236|Secondary|Transfusions|# of transfusions infants required after enrollment.|enrollment to 36 weeks postmenstrual age (PMA)|||transfusions||Inter-Quartile Range|Median
829837|NCT01224236|Primary|Hematocrit (Hct)|For infants discharged from the hospital before 36 weeks' postmenstrual age (PMA), the last Hct before discharge was used. For infants transferred before 36 weeks PMA, the Hct at 36 weeks was sought from the receiving hospital and used if available. For infants transferred before 36 weeks with no available Hct at 36 weeks, the last Hct before transfer was used. For those who died before 36 weeks PMA, the Hct at 36 weeks was considered to be missing.|36 weeks postmenstrual age (PMA)|||percentage of red blood cells in blood||Standard Deviation|Mean
829838|NCT01224431|Secondary|Heart Rate|patient on Cardiopulmonary monitoring|On average the first hour in the emergency department, at 4 time points during lumbar puncture procedure.||||||
829839|NCT01224431|Secondary|Length of Cry|cry video recorded and measured after needle stick until pt stopped crying|On average the first hour in the emergency department; from needle stick to end of lumbar puncture||||||
829840|NCT01224431|Primary|Pain, Measured as Units on a Scale|Pain scores at time of needle insertion using neonatal facial coding score. The scale has five components; cry, brow bulge, eye squeeze; nasolabial fold and open month. Each component is either present or absent, with a value of 0 or 1 given. Minimum score of 0 and a maximum score of 5 possible|on average the first hour in emergency department at 4 time points during entire lumbar puncture procedure.|||units on scale, 0-5||Standard Deviation|Mean
829841|NCT01224444|Secondary|Incomplete Adenoma Resection of Small and Large Adenomas|Comparison of the proportion of incompletely resected adenomatous polyps by size (5-9mm versus 10-20mm).|1 year||||||
829842|NCT01224444|Primary|Percent of Incompletely Resected Adenomatous Polyps|Proportion of incompletely resected adenomatous polyps (5 to 20mm), defined by remaining adenomatous tissue in marginal biopsies after snare resection.|1 year|||percentage of incomplete resection|Participants|95% Confidence Interval|Number
829843|NCT01231230|Primary|Maximum Change From Baseline in Airway Blood Flow (Qaw)||maximum change in Qaw within 240 minutes post drug inhalation|||change from baseline ( µl/min/ml)||Standard Error|Mean
829844|NCT01231321|Secondary|Change in Disease Activity Score (DAS28) Compared With Baseline|The DAS28 is validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health (patient's global assessment of disease activity) were included in the DAS28 score. Scores on the DAS28 range from 1 (inactive disease) to 10 (very active disease).|Baseline and 24 weeks|All subjects with data available from both Baseline and Week 24 were included in this intent-to-treat (ITT) analysis.||units on a scale||Standard Deviation|Mean
829845|NCT01231321|Primary|Vital Sign Values|"Vital signs values were assessed for values above and below the normal (reference) ranges used by the central laboratory.
Note, in table, BP = blood pressure."|24 weeks|All subjects with available data were included in this intent-to-treat (ITT) analysis.||participants|||Number
829846|NCT01231321|Primary|Deviation From Normal Laboratory Ranges|"Laboratory values were assessed for values above and below the normal (reference) ranges used by the central laboratory.
Note abbreviations used in table:
Alk. phosphatase = alkaline phosphatase, ALT = alanine aminotransferase, AST = aspartate aminotransferase, ESR = erythrocyte sedimentation rate"|24 weeks|All subjects with available data were included in this intent-to-treat (ITT) analysis. The number of subjects with available data is indicated for each laboratory assessment.||participants|||Number
829847|NCT01231321|Primary|Changes of Physical Examination|Physical examination findings were compared between Baseline and Week 24, and changes were recorded (Normal at Baseline to Abnormal at Week 24; or Abnormal at Baseline to Normal at Week 24). Physical examination criteria (normal vs. abnormal) were at the clinical judgement of the examining physician. Significant changes in physical examination from Baseline were considered to be adverse events.|Baseline and 24 weeks|All enrolled subjects with available data were included in this intent-to-treat (ITT) analysis.||participants|||Number
829864|NCT01233232|Primary|Change From Baseline to End of Treatment for FEV1 Pre-bronchodilator (Lung Function Test)|The change in FEV1 Pre-bronchodilator is calculated as the End of Treatment value minus the Baseline value.|Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)|||L||Standard Deviation|Mean
829848|NCT01231321|Primary|Frequency of Adverse Events|"Serious adverse events were collected from the time of informed consent, and nonserious adverse events were collected from the time of first dose of adalimumab, until 70 days after the last injection of adalimumab. Refer to the Reported Adverse Events section of this results disclosure for specific adverse events reported.
Note:
Severe events considerably interfered in patients' usual activities and may have been life-threatening.
Serious events were life-threatening; resulted in hospitalization, congenital anomalies, or disability; or required intervention to prevent seriousness."|Up to 34 weeks (24 week study treatment plus 70-day follow-up period)|All enrolled subjects were included in this intent-to-treat (ITT) analysis.||participants|||Number
829849|NCT01231334|Primary|Percentage of Participants With at Least a One Point Decrease in the Global Acne Assessment Score (GAAS) at Week 12|GAAS was conducted by the investigator at Baseline and Week 12. The patient's facial acne was evaluated on a 5 point scale 0=None (no evidence of acne), 1=Minimal (few lesions), 2=Mild (several to many non-inflammatory lesions; few inflammatory lesions), 3=Moderate (many lesions) to 4=Severe (Significant degree of inflammatory disease; papules/pustules present, few nodulo-cystic lesions; comedones may be present). Papules/nodules are round, solid elevations of the skin with no visible fluid. The percentage of participants with at least a one point decrease (improvement) in GAAS was calculated.|Baseline, Week 12|Per-Protocol Population consists of all randomized participants who completed the study to week 12 without any major protocol violation.||Percentage of participants|||Number
829850|NCT01231334|Secondary|Percentage of Participants Demonstrating a ≥ 1 Category Increase in Tolerability From Baseline at Week 12|The investigator rated the patient's current symptoms of erythema, dryness, peeling, and oiliness on a 5 point scale from 0 (Absent) to 4 (Severe). The investigator rated the symptoms of pruritus and burning since last visit on a 6 point scale of 0 (Absent) to 5 (Severe)-interfering with daily activities. Percentage of participants demonstrating a ≥1 category increase (improvement) in tolerability from baseline is calculated.|Baseline, Week 12|Per-Protocol Population consists of all randomized participants who completed the study to week 12 without any major protocol violation.||Percentage of participants|||Number
829851|NCT01231334|Secondary|Percent Change From Baseline in Total Lesion Count at Week 12|Percent change in total lesion counts: inflammatory (papules, pustules and nodules) and non-inflammatory (comedones) lesion counts from baseline. Papules and nodules are round, solid elevations of the skin with no visible fluid; papules are smaller (less than 5 or 10 millimeters ) and nodules are larger (greater than 5 or 10 millimeters). Pustules are small elevations of the skin containing cloudy material. Comedones are small bumps on the skin caused by acne and found at the opening of a skin pore. A negative change from baseline indicates a reduction in lesion counts (improvement).|Baseline, Week 12|Per-Protocol Population consists of all randomized participants who completed the study to week 12 without any major protocol violation.||Percent change||Full Range|Median
829852|NCT01231334|Secondary|Percent Change From Baseline in Non-inflammatory Lesion Counts at Week 12|"Percent Change from baseline in non-inflammatory lesion counts (open/closed comedones) at week 12. Comedones are small bumps on the skin (lesions) caused by acne and found at the opening of a skin pore. Open comedones (also known as a blackheads) have a microscopic opening to the skin surface, while closed comedones (also known as whiteheads or pimples) lack the opening to the skin. A negative number change from baseline indicates a reduction in lesion counts (improvement)."|Baseline, Week 12|Per-Protocol Population consists of all randomized participants who completed the study to week 12 without any major protocol violation.||Percent change||Full Range|Median
829853|NCT01231334|Secondary|Percent Change From Baseline in Inflammatory Lesion Counts at Week 12|Percent Change from baseline in inflammatory lesion counts (papules, pustules and nodules) at week 12. Papules and nodules are round, solid elevations of the skin with no visible fluid; papules are smaller (less than 5 or 10 millimeters in width and depth) and nodules are larger (greater than 5 or 10 millimeters in width and depth). Pustules are small elevations of the skin containing cloudy material. A negative number change from baseline indicates a reduction in lesion counts (improvement).|Baseline, Week 12|Per-Protocol Population consists of all randomized participants who completed the study to week 12 without any major protocol violation.||Percent change||Full Range|Median
829854|NCT01231334|Secondary|Percentage of Participants at Week 12 Having at Least a One Point Decrease in Overall Disease Severity|The overall disease severity was evaluated by the investigator at Baseline and Week 12 using a 7-point scale to rate the overall acne severity (lesions, inflammation, facial redness and skin condition), where 0=no acne lesions and 6=most severe acne. The percentage of participants with at least a one point decrease (improvement) from baseline is calculated.|Baseline, Week 12|Per-Protocol Population consists of all randomized participants who completed the study to week 12 without any major protocol violation.||Percentage of participants|||Number
829855|NCT01231334|Secondary|Change From Baseline in Global Acne Assessment Score (GAAS) at Week 12|GAAS was conducted by the investigator. The patient's facial acne was evaluated on a 5 point scale 0=None (no evidence of acne), 1=Minimal (few lesions), 2=Mild (several to many non-inflammatory lesions; few inflammatory lesions), 3=Moderate (many lesions) to 4=Severe (Significant degree of inflammatory disease; papules/pustules present, few nodulo-cystic lesions; comedones may be present). Papules and nodules are round, solid elevations of the skin with no visible fluid. A negative change from baseline indicates improvement.|Baseline, Week 12|Per-Protocol Population consists of all randomized participants who completed the study to week 12 without any major protocol violation.||Score on a scale||Standard Deviation|Mean
829856|NCT01233232|Secondary|Maximum Reduction of Circulating Neutrophils in Blood, From Baseline|The change in circulating neutrophils in blood is calculated as the visit value minus the Baseline value. Only participants with reduction are considered.|Baseline (last non-missing assessment prior to first dose of study medication), weeks 1, 2 and 3, and End of Treatment (Day 28)|||10^9/L cells/L||Standard Deviation|Mean
829857|NCT01233232|Secondary|Time to Maximum Plasma Concentration for AZD5069|Time (in relation to dosing) at which the maximum plasma concentration is observed.|End of Treatment (Day 28); pre-dose, 1, 2, 3, and 5 hours after dosing|||hours||Inter-Quartile Range|Median
829858|NCT01233232|Secondary|Maximum Plasma Concentration for AZD5069|The maximum plasma concentration (Cmax) is the highest level of drug in plasma.|End of Treatment (Day 28); pre-dose, 1, 2, 3, and 5 hours after dosing|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
829859|NCT01233232|Secondary|Area Under the Plasma Concentration Curve of AZD5069|The area under the plasma concentration curve is estimated from time 0 (dosing) to 24 hours after dosing.|End of Treatment (Day 28); pre-dose, 1, 2, 3, and 5 hours after dosing|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
829865|NCT01233232|Primary|Change From Baseline to End of Treatment for Pulse Rate (Vital Signs)|The change in pulse rate (Vital Sign) is calculated as the End of Treatment value minus the Baseline value.|Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)|||beats/minute||Standard Deviation|Mean
829866|NCT01233232|Primary|Change From Baseline to End of Treatment for Diastolic Blood Pressure (Vital Signs)|The change in diastolic blood pressure (Vital Sign) is calculated as the End of Treatment value minus the Baseline value.|Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)|||mmHg||Standard Deviation|Mean
829867|NCT01233232|Primary|Change From Baseline to End of Treatment for Systolic Blood Preassure (Vital Signs)|The change in systolic blood pressure (Vital Sign) is calculated as the End of Treatment value minus the Baseline value.|Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)|||mmHg||Standard Deviation|Mean
829868|NCT01233232|Primary|Change From Baseline to End of Treatment for Body Temperature|The change in body temperature (oral) is calculated as the End of Treatment value minus the Baseline value.|Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)|||degrees C||Standard Deviation|Mean
829869|NCT01233232|Primary|Change From Baseline to End of Treatment for Leucocytes Count in Blood (Safety Blood Sample)|The change in circulating leucocyte counts (including neutrophils) is calculated as the End of Treatment value minus the Baseline value.|Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)|||10^9/L cells/L||Standard Deviation|Mean
829870|NCT01233232|Primary|Number of Participants With Abnormal Electrocardiogram (ECG)|ECGs were recorded in the supine position after the patient has rested for 10 minutes. Heart rate, QRS duration, PR, RR and QT intervals were recorded. Overall evaluation of the ECG is classified as normal, abnormal or borderline. Only participants with ECG at baseline classified as normal are reported (ie, only changes from normal to abnormal).|Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)|||Participants|||Number
829871|NCT01233232|Primary|Number of Participants With Abnormal Physical Examination Findings|Physical examination includes assessment of general appearance, skin, head and neck (including ears, eyes, nose and throat), lymph nodes, musculo-skeletal (including spine and extremities), cardiovascular, lungs and abdomen. The findings were deemed to be normal/abnormal based on the clinical judgment of the investigator.|Last Observation on Treatment (up to Day 28)|||Participants|||Number
829872|NCT01233232|Primary|Patients Who Experienced at Least One Adverse Events(s)|Adverse event (AE) data, both serious and non-serious. An AE is the development of an undesirable medical condition (eg, nausea, chest pain, tachycardia, laboratory findings) or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.|From start of treatment (Day 0) up to 28 days (End of Treatment)|||Participants|||Number
829873|NCT01233258|Other Pre-specified|Number of Participants With Inhibitory Antibody Formation|A test to ensure that participants have not developed antibodies that will interfere with the action of rFVIII (BAY81-8973)|3, 6, 9 and 12 months after baseline|Safety population||Participants|||Number
829874|NCT01233258|Other Pre-specified|Number of Bleeds During Treatment|The number of bleeds experienced by each participant|12 months|ITT||Bleeds||Inter-Quartile Range|Median
829875|NCT01233258|Secondary|Percentage of Bleeds Per Participant Controlled With ≤ 2 Injections in Participants Treated on Demand With rFVIII (BAY81-8973)|The percentage of bleeds per participant on on-demand treatment that stopped after two or fewer injections|Up to 12 months (6 months per mode of potency assignment according to the randomized cross-over design)|ITT||Percentage of bleeds||Full Range|Median
829876|NCT01233258|Secondary|Annualized Number of All Bleeds During CS/ADJ Period|The annualized number of bleeds experienced by participants while they were taking rFVIII (BAY81-8973) assayed by CS/ADJ|Up to 6 months (6 months on CS/ADJ potency assignment)|ITT. Low and high dose prophylaxis arms combined as planned for the statistical analysis to achieve sufficient sample size.||Bleeds per year per participant||Standard Deviation|Mean
829877|NCT01233258|Secondary|Annualized Number of All Bleeds During CS/EP Period|The annualized number of bleeds experienced by participants while they were taking rFVIII (BAY81-8973) assayed by CS/EP|Up to 6 months (6 months on CS/EP potency assignment)|ITT. Low and high dose prophylaxis arms combined as planned for the statistical analysis to achieve sufficient sample size.||Bleeds per year per participant||Standard Deviation|Mean
829878|NCT01233258|Primary|Annualized Number of All Bleeds|The annualized number of bleeds experienced by participants|Up to 12 months (6 months per mode of potency assignment according to the randomized cross-over design)|ITT (Intent to Treat). Low and high dose prophylaxis arms and both potencies combined as planned for the statistical analysis to achieve intended sample size.||Bleeds per year per participant||Standard Deviation|Mean
829879|NCT01233284|Secondary|FVC Area Under the Curve Within 24 Hours (h) Response (FVC AUC0-12h, FVC AUC12-24h, FVC AUC0-24h)|MMRM results. Response was defined as change from baseline at the end of of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. FVC AUC0-12, FVC AUC12-24 and FVC AUC0-24 were calculated using the trapezoidal rule divided by the observation time (12h resp. 24h) to report in litres.|10 minutes (min) before drug administration and 30 min, 1h, 2h, 3h, 4h, 11h 50min, 12h 30min, 13h, 14h, 15h, 16h, 18h, 20h, 22h, 23h, 23h 50min after drug administration|FAS24 was defined as all patients in the FAS who gave informed consent for the 24-h PFT and who participated in this optional PFT.||Litres||Standard Error|Mean
829880|NCT01233284|Secondary|FEV1 Area Under the Curve Within 24 Hours (h) Response (FEV1 AUC0-12h, FEV1 AUC12-24h, FEV1 AUC0-24h)|MMRM results. Response was defined as change from baseline at the end of of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. FEV1 AUC0-12, FEV1 AUC12-24 and FEV1 AUC0-24 were calculated using the trapezoidal rule divided by the observation time (12h resp. 24h) to report in litres.|10 minutes (min) before drug administration and 30 min, 1h, 2h, 3h, 4h, 11h 50min, 12h 30min, 13h, 14h, 15h, 16h, 18h, 20h, 22h, 23h, 23h 50min after drug administration|FAS24 was defined as all patients in the FAS who gave informed consent for the 24-h PFT and who participated in this optional PFT.||Litres||Standard Error|Mean
829907|NCT01233726|Primary|Primary Outcome: Measure of Biochemical Parameters and Evaluation of Infectious Complications 6.1|This table shows the number of capillary glycemia measurements|28 days post-admission|||number of capillary glycemia measurement|||Number
829881|NCT01233284|Secondary|Mean Number of Night Awakenings During the Last Week on Treatment (Score, Response Values)|MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. Weekly means obtained during the last week of each period of randomised treatment will be compared (measured by patients at home using the AM2+ device).|Baseline and 4 weeks|FAS reduced to patients with non-missing data for nighttime awakenings||Night awakenings||Standard Error|Mean
829882|NCT01233284|Secondary|Mean Number of Puffs of Rescue Medication During Nighttime (Last Week on Treatment, Response Values)|MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. Weekly means obtained during the last week of each period of randomised treatment will be compared (measured by patients at home using the AM2+ device).|Baseline and 4 weeks|FAS reduced to patients with non-missing data for rescue medication.||Puffs||Standard Error|Mean
829883|NCT01233284|Secondary|Mean Number of Puffs of Rescue Medication During Daytime (Last Week on Treatment, Response Values)|MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. Weekly means obtained during the last week of each period of randomised treatment will be compared (measured by patients at home using the AM2+ device).|Baseline and 4 weeks|FAS reduced to patients with non-missing data for rescue medication.||Puffs||Standard Error|Mean
829884|NCT01233284|Secondary|Mean Number of Puffs of Rescue Medication During the Whole Day (Last Week on Treatment, Response Values)|MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. Weekly means obtained during the last week of each period of randomised treatment will be compared (measured by patients at home using the AM2+ device).|Baseline and 4 weeks|FAS reduced to patients with non-missing data for rescue medication.||Puffs||Standard Error|Mean
829885|NCT01233284|Secondary|PEF Variability Response (Last Week on Treatment)|MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. PEF variability is the absolute difference between morning and evening PEF value divided by the mean of these two values, expressed as a percent . Weekly means obtained during the last week of each period of randomised treatment will be compared.|Baseline and 4 weeks|FAS reduced to patients with non-missing morning and evening PEF data.||Percentage of the mean daily PEF||Standard Error|Mean
829886|NCT01233284|Secondary|Mean Pre-dose Evening PEF (PEF p.m.) Response During the Last Week on Treatment|MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. Weekly means obtained during the last week of each period of randomised treatment will be compared (measured by patients at home using the AM2+ device).|Baseline and 4 weeks|FAS reduced to patients with non-missing evening PEF data.||Litre/min||Standard Error|Mean
829887|NCT01233284|Secondary|Mean Pre-dose Morning PEF (PEF a.m.) Response During the Last Week on Treatment|MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. Weekly means obtained during the last week of each period of randomised treatment will be compared (measured by patients at home using the AM2+ device).|Baseline and 4 weeks|FAS reduced to patients with non-missing morning PEF data.||Litre/min||Standard Error|Mean
829888|NCT01233284|Secondary|Individual Peak Expiratory Flow (PEF) Over Time (at Each Timepoint at Visits) Response|MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline.|Baseline and 4 weeks|FAS reduced to patients with non-missing PEF data.||Litre/min||Standard Error|Mean
829889|NCT01233284|Secondary|Individual FVC Over Time (at Each Timepoint at Visits) Response|MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline.|Baseline and 4 weeks|FAS reduced to patients with non-missing FVC data.||Litre||Standard Error|Mean
829890|NCT01233284|Secondary|Individual FEV1 Over Time (at Each Timepoint at Visits) Response|MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline.|Baseline and 4 weeks|FAS reduced to patients with non-missing FEV1 data.||Litre||Standard Error|Mean
829891|NCT01233284|Secondary|FVC AUC0-3h Response|MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. FVC AUC0-3h was calculated using the trapezoidal rule divided by the observation time (3 hours) to report in litres.|10 minutes (min) before drug administration and 30 min, 1h, 2h, 3h after drug administration|FAS reduced to patients with non-missing FVC data.||Litre||Standard Error|Mean
829892|NCT01233284|Secondary|Trough FVC Response|MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. Trough FVC was measured just prior to the last administration of randomised treatment.|Baseline and 4 weeks|FAS reduced to patients with non-missing FVC data.||Litre||Standard Error|Mean
829893|NCT01233284|Secondary|Forced Vital Capacity (FVC) Peak Within 0-3 Hours Post-dose Response|MMRM results. Response was defined as change from baseline at the end of of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline.|10 minutes (min) before drug administration and 30 min, 1h, 2h, 3h after drug administration|FAS reduced to patients with non-missing FVC data.||Litre||Standard Error|Mean
829894|NCT01233284|Secondary|FEV1 Area Under the Curve 0-3 Hours (AUC0-3h) Response|MMRM results. Response was defined as change from baseline at the end of of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. FEV1 AUC0-3h was calculated using the trapezoidal rule divided by the observation time (3 hours) to report in litres.|10 minutes (min) before drug administration and 30 min, 1h, 2h, 3h after drug administration|FAS reduced to patients with non-missing FEV1 data.||Litre||Standard Error|Mean
829895|NCT01233284|Secondary|Trough FEV1 Response|MMRM results. Response was defined as change from baseline at the end of of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. Trough FEV1 was measured just prior to the last administration of randomised treatment.|Baseline and 4 weeks|FAS reduced to patients with non-missing FEV1 data.||Litre||Standard Error|Mean
829896|NCT01233284|Primary|Forced Expiratory Volume in One Second (FEV1) Peak Within 0-3 Hours Post-dose Response|Mixed model repeated measurement (MMRM) results. Response was defined as change from baseline at the end of of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline.|10 minutes (min) before drug administration and 30 min, 1h, 2h, 3h after drug administration|Full analysis set (FAS) reduced to patients with non-missing FEV1 data. The FAS is defined as patients randomised, treated, with baseline data and at least one on-treatment efficacy measurement after 4 weeks on treatment within a period.||Litre||Standard Error|Mean
829897|NCT01233687|Secondary|Overall Survival (OS)|Overall Survival was computed for all participants and is defined as the time between start of treatment and death. The (median) length of time in months that subjects with previously-treated advanced NSCLC, treated with the combination of AMG 102 and erlotinib, remain alive estimated by the Kaplan-Meier method.|Up to 24 months (after the first evaluable patient is accrued)|All patients who who received at least one dose of AMG 102 and had post-treatment imaging studies for response evaluation using Response Evaluation Criteria in Solid Tumors (RECIST) Criteria at six weeks (RESPONSE EVALUABLE)||months||90% Confidence Interval|Median
829898|NCT01233687|Secondary|Progression-free Survival (PFS)|Progression-free survival is defined as the time from the start of treatment until first evidence of disease progression, death, or date of last contact. The (median) length of time that subjects with previously-treated advanced NSCLC, who were treated with the combination of AMG 102 and erlotinib, are both alive and free of disease progression as estimated by the Kaplan-Meier method. For participants not known to have died as of the data cut-off date and who did not have PD, the PFS date was censored at the last contact date (contacts considered in the determination of last progression free disease assessment).|Up to 24 months (after the first patient is accrued)|All patients who who received at least one dose of AMG 102 and had post-treatment imaging studies for response evaluation using Response Evaluation Criteria in Solid Tumors (RECIST) Criteria at six weeks (RESPONSE EVALUABLE)||months||90% Confidence Interval|Median
829899|NCT01233687|Secondary|Objective Response Rate (ORR/Clinical Response)|Using RECIST v1.1 criteria, ORR was determined by following equation: the number of partial response (PR) participants / the number of partial response (PR) participants + the number of stable disease (SD) participants + the number of progressive disease (PD) participants.|Up to 6 months|All patients who who received at least one dose of AMG 102 and had post-treatment imaging studies for response evaluation using Response Evaluation Criteria in Solid Tumors (RECIST) Criteria at six weeks (RESPONSE EVALUABLE)||percentage of patients||90% Confidence Interval|Number
829900|NCT01233687|Primary|Disease Control Rate (DCR)|Using RECIST v1.1 criteria, DCR was determined by following equation: the number of complete response (CR) participants + the number of partial response (PR) participants + the number of stable disease (SD) participants / the number of complete response (CR) participants + the number of partial response (PR) participants + the number of stable disease (SD) participants + the number of progressive disease (PD) participants.|Six weeks from initiation of treatment with AMG 102 + Erlotinib|All patients who who received at least one dose of AMG 102 and had post-treatment imaging studies for response evaluation using Response Evaluation Criteria in Solid Tumors (RECIST) Criteria at six weeks (RESPONSE EVALUABLE)||percentage of patients||90% Confidence Interval|Number
829901|NCT01233687|Primary|Percentage of Participants That Experienced a Dose Limiting Toxicity|Determination of the safety and recommended phase II dose of AMG 102 when combined with erlotinib for the treatment of patients with advanced, previously-treated NSCLC.|During first cycle of treatment (3 weeks)|In the absence of DLTs among the first 7 pts treated, AMG 102 + Erlotinib (150 mg) daily (3 weeks) was declared the RP2D.||percentage of participants||90% Confidence Interval|Number
829902|NCT01233726|Secondary|Assessment of Critical Ill Patients Progress During Hospital Stay 4|Number of participants with infectious complications is provided in this table.|100 days of treatment|Age ≥18 years, ICU stay ≤48 hours upon randomization to EN formula, mechanical ventilation, EN indicated for an expected time ≥5 days. Patients were also required to meet American Diabetes Association criteria for diabetes/hyperglycemia (baseline blood glucose >126 mg/dL after fasting or>200 mg/dL otherwise) in the first 48 h of ICU admission.||participants|||Number
829903|NCT01233726|Secondary|Assessment of Critical Ill Patients Progress During Hospital Stay 3|The incidence of tracheobronchitis and ventilator-associated pneumonia per 1000 days of mechanical ventilation are provided in this table.|28 days post-admission|Age ≥18 years, ICU stay ≤48 hours upon randomization to EN formula, mechanical ventilation, EN indicated for an expected time ≥5 days. Patients were also required to meet American Diabetes Association criteria for diabetes/hyperglycemia (baseline blood glucose >126 mg/dL after fasting or>200 mg/dL otherwise) in the first 48 h of ICU admission.||number of new cases per 1000 days|||Number
829904|NCT01233726|Secondary|Assessment of Critical Ill Patients Progress During Hospital Stay 2|Number of participants with catheter-associated bloodstream infection, primary bloodstream infection or urinary tract infection are provided in this table|28 days post-admission|Age ≥18 years, ICU stay ≤48 hours upon randomization to EN formula, mechanical ventilation, EN indicated for an expected time ≥5 days. Patients were also required to meet American Diabetes Association criteria for diabetes/hyperglycemia (baseline blood glucose >126 mg/dL after fasting or>200 mg/dL otherwise) in the first 48 h of ICU admission.||participants|||Number
829905|NCT01233726|Secondary|Assessment of Critical Ill Patients Progress During Hospital Stay 1|Infectious complication incidence rate per 100 days of treatment are provided in this table.|100 days of treatment|Age ≥18 years, ICU stay ≤48 hours upon randomization to EN formula, mechanical ventilation, EN indicated for an expected time ≥5 days. Patients were also required to meet American Diabetes Association criteria for diabetes/hyperglycemia (baseline blood glucose >126 mg/dL after fasting or>200 mg/dL otherwise) in the first 48 h of ICU admission.||percentage of patients with infection|||Number
829906|NCT01233726|Primary|Measure of Biochemical Parameters and Evaluation of Infectious Complications 6.2|"This table shows the rates of:
Controls analysis on 80-150 mg/dL: optimal level of glycemia rate.
Hypoglycemia (50-80 mg/dL): moderate hypoglycemia rate.
Hypoglycemia (<50 mg/dL): severe hypoglycemia episodes rate."|28 days post-admission|Age ≥18 years, ICU stay ≤48 hours upon randomization to EN formula, mechanical ventilation, EN indicated for an expected time ≥5 days. Patients were also required to meet American Diabetes Association criteria for diabetes/hyperglycemia (baseline blood glucose >126 mg/dL after fasting or>200 mg/dL otherwise) in the first 48 h of ICU admission.||% of capillary glycemia measurements|||Number
829908|NCT01233726|Primary|Measure of Biochemical Parameters and Evaluation of Infectious Complications 5|"The variables recorded related to Glycemic CV (%) are provided in this table:
Glycemic Coeficient of variation (%) after 28 days in ICU
Glycemic Coeficient of variation (%) after 7 days in ICU."|28 days post-admission|Age ≥18 years, ICU stay ≤48 hours upon randomization to EN formula, mechanical ventilation, EN indicated for an expected time ≥5 days. Patients were also required to meet American Diabetes Association criteria for diabetes/hyperglycemia (baseline blood glucose >126 mg/dL after fasting or>200 mg/dL otherwise) in the first 48 h of ICU admission.||percentage of Glycemic CV||Standard Deviation|Mean
829909|NCT01233726|Primary|Measure of Biochemical Parameters and Evaluation of Infectious Complications 4|The variables recorded related to the number of measurements per patient per day are provided in this table|28 days post-admission|Age ≥18 years, ICU stay ≤48 hours upon randomization to EN formula, mechanical ventilation, EN indicated for an expected time ≥5 days. Patients were also required to meet American Diabetes Association criteria for diabetes/hyperglycemia (baseline blood glucose >126 mg/dL after fasting or>200 mg/dL otherwise) in the first 48 h of ICU admission.||Measurements per patient/day||Standard Deviation|Mean
829910|NCT01233726|Primary|Measure of Biochemical Parameters and Evaluation of Infectious Complications 3|The variables recorded related to number of capillary glycemia measurements are provided in this table|28 days post-admission|Age ≥18 years, ICU stay ≤48 hours upon randomization to EN formula, mechanical ventilation, EN indicated for an expected time ≥5 days. Patients were also required to meet American Diabetes Association criteria for diabetes/hyperglycemia (baseline blood glucose >126 mg/dL after fasting or>200 mg/dL otherwise) in the first 48 h of ICU admission.||Capillary glycemia measurements|||Number
829911|NCT01233726|Primary|Measure of Biochemical Parameters and Evaluation of Infectious Complications 2|The variables recorded related to administered insulin in IU/day are provided in this table|28 days post-admission|Age ≥18 years, ICU stay ≤48 hours upon randomization to EN formula, mechanical ventilation, EN indicated for an expected time ≥5 days. Patients were also required to meet American Diabetes Association criteria for diabetes/hyperglycemia (baseline blood glucose >126 mg/dL after fasting or>200 mg/dL otherwise) in the first 48 h of ICU admission.||IU/day||Standard Deviation|Mean
829912|NCT01233726|Primary|Measure of Biochemical Parameters and Evaluation of Infectious Complications 1|The variables recorded related to glycemic control in mg/dL are provided in this table.|28 days post-admission|Age ≥18 years, ICU stay ≤48 hours upon randomization to EN formula, mechanical ventilation, EN indicated for an expected time ≥5 days. Patients were also required to meet American Diabetes Association criteria for diabetes/hyperglycemia (baseline blood glucose >126 mg/dL after fasting or>200 mg/dL otherwise) in the first 48 h of ICU admission.||mg/dL||Standard Deviation|Mean
829913|NCT01233817|Primary|Strength|Primary Outcome Measure was muscle strength. Strength was measured using a fixed myometry evaluation, quantitative muscle analysis (QMA). QMA utilizes a relative fixed point for the participant to exert effort. Each muscle of interest was tested using QMA.|12 weeks|||kilograms||95% Confidence Interval|Median
829914|NCT01233869|Other Pre-specified|Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings|ECGs were centrally evaluated. ECG parameters included PR interval, QRS interval, and corrected QT interval using Fridericia's formula (QTcF). Criteria for ECG changes meeting potential clinical concern included: PR interval greater than or equal to (≥)300 milliseconds (msec) or ≥25% increase when baseline is greater than (>)200 msec and ≥50% increase when baseline is less than or equal to (≤)200 msec; QRS interval ≥200 msec or ≥25%/50% increase from baseline; and QTcF ≥450 msec or ≥30 msec increase.|Baseline up to 30 days after last study drug administration|The safety analysis population included all participants who received at least 1 dose of study drug; n=the number of participants analyzed in the respective arms.||participants|||Number
829915|NCT01233869|Other Pre-specified|Number of Participants With Potentially Clinically Significant Vital Signs Findings|Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: supine/sitting pulse rate <40 or >120 beats per minute (bpm), standing pulse rate <40 or >140 bpm; systolic blood pressure (SBP) of >=30 millimeters of mercury (mm Hg) change from baseline in same posture or SBP <90 mm Hg, diastolic blood pressure (DBP) >=20 mmHg change from baseline in same posture or DBP <50 mm Hg.|Baseline up to 30 days after last study drug administration|The safety analysis population included all participants who received at least 1 dose of study drug; n=the number of participants analyzed in the respective arms.||participants|||Number
829916|NCT01233869|Other Pre-specified|Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern|The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell [RBC] count, RBC morphology, platelet count, white blood cell [WBC] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen [BUN], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, alkaline phosphatase, uric acid, albumin, and total protein; urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, microscopy [if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase]); others (coagulation panel, circulating immune complex, and complement activation).|Baseline up to 30 days after last study drug administration|The safety analysis population included all participants who received at least 1 dose of study drug.||participants|||Number
829917|NCT01233869|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.|Baseline up to 30 days after last study drug administration|The safety analysis population included all participants who received at least 1 dose of study drug.||participants|||Number
829977|NCT01234714|Secondary|Operative Time|The operation duration was measured according to the total minutes from the beginning of the operation until the end.|December 2010|According to MRI||min||Inter-Quartile Range|Median
829918|NCT01233869|Secondary|Change From Baseline in Kidney Disease Quality of Life (KDQoL)-36 Scale Scores at Month 25|The KDQoL-36 is a 36-item questionnaire on kidney disease-specific measure of patient-reported quality of life with 5 subscales: physical and mental functioning (items 1-12); burden of kidney disease subscale (items 13-16); symptoms and problems (items 17-28); effects of kidney disease on daily life subscale (items 29-36). The raw scores are transformed linearly to a range of 0 to 100, with higher scores indicating better quality of life.|Baseline and end of ITPV (Month 25)|The mITT-2 population included all participants who were randomized and received at least 2 weeks' worth of treatment and have at least 1 post-randomization follow-up MRI assessment (elimination of 1-month washout); n=the number of participants analyzed in the respective arms.||units on a scale||Standard Deviation|Mean
829919|NCT01233869|Secondary|Observed Accumulation Ratio (Rac) of Bosutinib|Observed accumulation ratio (Rac) was calculated as AUC from time 0 to 24 hours (Day 15) divided by AUC from time 0 to 24 hours (Day 1).|Day 15 (pre-dose and 1, 2, 3, 4, 6, 8 and 24 hours post-dose)|The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest.||ratio||Geometric Coefficient of Variation|Geometric Mean
829920|NCT01233869|Secondary|Terminal Elimination Half-Life (t1/2) of Bosutinib|t1/2 is the time measured for the plasma concentration to decrease by one half.|Day 1 (pre-dose and 1, 3, 5 and 24 hours post-dose), Day 15 (pre-dose and 1, 2, 3, 4, 6, 8 and 24 hours post-dose)|The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. There was no sufficient data to well-characterize the terminal phase, therefore t1/2 was not reported.|||||
829921|NCT01233869|Secondary|Apparent Volume of Distribution (Vz/F) of Bosutinib|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|Day 1 (pre-dose and 1, 3, 5 and 24 hours post-dose), Day 15 (pre-dose and 1, 2, 3, 4, 6, 8 and 24 hours post-dose)|The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. There was no sufficient data to well-characterize the terminal phase, therefore Vz/F was not reported.|||||
829922|NCT01233869|Secondary|Apparent Oral Clearance (CL/F) of Bosutinib|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Day 15 (pre-dose and 1, 2, 3, 4, 6, 8 and 24 hours post-dose)|The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest.||L/hr||Geometric Coefficient of Variation|Geometric Mean
829923|NCT01233869|Secondary|Lowest Concentration Observed During the Dosing Interval (Cmin) of Bosutinib||Day 15 (pre-dose and 1, 2, 3, 4, 6, 8 and 24 hours post-dose)|The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
829924|NCT01233869|Secondary|Area Under the Concentration-Time Profile From Time 0 to the Dosing Interval (AUCtau) of Bosutinib|Area under the concentration-time profile from time 0 to time tau, the dosing interval, where tau=24 hours.|Day 1 (pre-dose and 1, 3, 5 and 24 hours post-dose), Day 15 (pre-dose and 1, 2, 3, 4, 6, 8 and 24 hours post-dose)|The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest; n=the number of participants analyzed at that time point in the respective arms.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
829925|NCT01233869|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Bosutinib||Day 1 (pre-dose and 1, 3, 5 and 24 hours post-dose), Day 15 (pre-dose and 1, 2, 3, 4, 6, 8 and 24 hours post-dose)|The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest; n=the number of participants analyzed at that time point in the respective arms.||hours||Full Range|Median
829926|NCT01233869|Secondary|Maximum Observed Plasma Concentration (Cmax) of Bosutinib||Day 1 (pre-dose and 1, 3, 5 and 24 hours post-dose), Day 15 (pre-dose and 1, 2, 3, 4, 6, 8 and 24 hours post-dose)|The pharmacokinetic (PK) parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest; n=the number of participants analyzed at that time point in the respective arms.||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
829927|NCT01233869|Secondary|Number of Participants With High Serum Creatinine (SCr) Levels|A SCr test can reveal how well the kidneys are working by measuring the amount of urea nitrogen in the blood. A high SCr level (>1.3 times the upper limit of normal) may suggest that the kidneys are not working properly. Month 25 is the end of the ITPV.|Day 15, Months 6, 12, 18, 24, and 25 (end of ITPV)|The safety analysis population included all participants who received at least 1 dose of study drug.||participants|||Number
829928|NCT01233869|Secondary|Number of Participants With High Blood Urea Nitrogen (BUN) Levels|A BUN test can reveal how well the kidneys are working by measuring the amount of urea nitrogen in the blood. A high BUN level (>1.3 times the upper limit of normal) may suggest that the kidneys are not working properly. Month 25 is the end of the ITPV.|Day 15, Months 6, 12, 18, 24, and 25 (end of ITPV)|The safety analysis population included all participants who received at least 1 dose of study drug.||participants|||Number
829929|NCT01233869|Secondary|Time to First Occurrence of End-Stage Renal Disease (ESRD) Requiring Dialysis >=56 Days|ESRD is when the kidneys permanently fail to work at a level needed for daily life. No participants developed ESRD during the treatment period, therefore the analysis of the onset of ESRD requiring ≥56 days of dialysis was not performed.|Baseline up to Month 25 (end of ITPV)|The mITT-2 population included all participants who were randomized and received at least 2 weeks' worth of treatment and have at least 1 post-randomization follow-up MRI assessment (elimination of 1-month washout requirement).||days|||Number
829930|NCT01233869|Secondary|Time to First Occurrence of Proteinuria|Proteinuria is the presence of an excess of serum proteins in the urine, which may be an early sign of kidney disease. The numbers presented correspond to the very first occurrence of proteinuria in that treatment group.|Baseline up to Month 25 (end of ITPV)|The mITT-2 population included all participants who were randomized and received at least 2 weeks' worth of treatment and have at least 1 post-randomization follow-up MRI assessment (elimination of 1-month washout requirement).||days|||Number
829931|NCT01233869|Secondary|Time to First Occurrence of Gross Hematuria|Gross hematuria is the presence of blood in the urine (defined as pink, red, or cola-colored urine due to the presence of red blood cells). The numbers presented correspond to the very first occurrence of gross hematuria in that treatment group.|Baseline up to Month 25 (end of ITPV)|The mITT-2 population included all participants who were randomized and received at least 2 weeks' worth of treatment and have at least 1 post-randomization follow-up MRI assessment (elimination of 1-month washout requirement).||days|||Number
829932|NCT01233869|Secondary|Time to First Occurrence or Worsening of Back and/or Flank Pain|The time to first occurrence or worsening of back and/or flank pain was observed (defined as initial onset of polycystic kidney disease [PKD]-related chronic back and/or flank pain; initiation of pain medication treatment for PKD-related chronic back and/or flank pain; addition of a pain medicine for treatment of PKD-related chronic back and/or flank pain; increase in dose of pain medication for treatment of PKD-related chronic back and/or flank pain). The numbers presented correspond to the very first occurrence or worsening of back and/or flank pain in that treatment group.|Baseline up to Month 25 (end of ITPV)|The mITT-2 population included all participants who were randomized and received at least 2 weeks' worth of treatment and have at least 1 post-randomization follow-up MRI assessment (elimination of 1-month washout requirement).||days|||Number
829933|NCT01233869|Secondary|Time to First Occurrence or Worsening of Hypertension|The time to first occurrence or worsening of hypertension was observed (defined as the need for increased dose of or need for additional anti-hypertensive medication). The numbers presented correspond to the very first occurrence or worsening of hypertension in that treatment group.|Baseline up to Month 25 (end of ITPV)|The mITT-2 population included all participants who were randomized and received at least 2 weeks' worth of treatment and have at least 1 post-randomization follow-up MRI assessment (elimination of 1-month washout requirement).||days|||Number
829934|NCT01233869|Secondary|Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Months 12, 24, 25 and Early Termination|eGFR was centrally evaluated. Glomerular filtration rate (GFR) is an index of kidney function that describes the flow of filtered fluid through the kidney. The Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation was used to calculate eGFR. Month 25 is the end of the ITPV.|Baseline, Month 12, Month 24, Month 25 (end of ITPV), and early termination|The mITT population included all participants who were randomized and received at least 2 weeks' worth of treatment and have at least 1 post-randomization follow-up MRI assessment; n=the number of participants analyzed at that time point in the respective arms.||mL/min/1.73m^2||Standard Deviation|Mean
829935|NCT01233869|Primary|Change From Baseline (CFB) in Total Kidney Volume (TKV) at Month 25|TKV was measured by centrally evaluated Magnetic Resonance Imaging (MRI).|Baseline and Month 25 (end of Initial Treatment Period Visit [ITPV])|The modified intent-to-treat (mITT) population included all participants who were randomized and received at least 2-weeks' worth of treatment and have at least 1 follow-up MRI assessment that was preceded by a 1-month washout of the study drug; n=the number of participants analyzed at that time point in the respective arms.||centimeter cube (cm^3)||Standard Deviation|Mean
829936|NCT01233921|Secondary|Changes in the Number of Naive CD4 T Cells in the Blood|Naive CD4 T cells will be defined according to co-expression of CD3, CD4, CD45RA, and CCR7. Positive results indicate an increase in the number of cells between baseline and 4 weeks. Negative results indicate a decrease in the number of cells between baseline and 4 weeks.|Baseline and 4 weeks after administration of palifermin|||cells per microliter of blood||Standard Deviation|Mean
829937|NCT01233921|Primary|Changes in the Number of Recent Thymic Emigrants (RTE) Cluster of Differentiation (CD)4 T Cells in the Blood|RTE CD4 T cells will be defined according to co-expression of CD3, CD4, CD31, CD45RA, and CCR7. Cells will be counted by flow cytometry at baseline and at 4 weeks and changes will be measured as cells per microliter of blood. Positive results indicate an increase in the number of cells between baseline and 4 weeks. Negative results indicate a decrease in the number of cells between baseline and 4 weeks.|Baseline and 4 weeks after administration of palifermin|||cells per microliter of blood||Standard Deviation|Mean
829938|NCT01233999|Primary|Mean Digital Temperature Difference From Baseline|Each digit temperature was measured and recorded at baseline, and then measured and re-recorded after 3 minute intervals following a 20 second 4 degree Celsius ice bath immersion.|6 weeks|||Celsius||95% Confidence Interval|Mean
829939|NCT01234103|Secondary|Self-reported Behavioral Measures Related to STI/HIV Prevention||6 to 9 months|No data were collected from participants. Participants only attended intervention sessions.|||||
829940|NCT01234103|Primary|Incidence of Sexually Transmitted Infections and the Self-reported Numbers of Unintended Pregnancies||6 to 9 months|No data were collected from participants. Participants only attended intervention sessions.|||||
829941|NCT01234207|Primary|Questionnaire Battery|Forced-choice Likert scale preference questionnaire|At study exit, after both Test and Control spectacles had been worn for 1 week each|95 presbyopic subjects wearing standard, non-free-form, non-customized PAL spectacles for 1 week, and individually customized, free-form surfaced PAL spectacles for 1 week, in randomized order, with a 1-week washout period||percentage of participants|||Number
829942|NCT01234207|Primary|Horizontal Extent of Undistorted Vision at Reading Distance|Novel apparatus designed to immobilize head and allow subject to indicate point of peripheral optical distortion on a modified Amsler-type grid|Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles|95 presbyopic subjects wearing standard, non-free-form, non-customized PAL spectacles for 1 week, and individually customized, free-form surfaced PAL spectacles for 1 week, in randomized order, with a 1-week washout period||cm||Standard Deviation|Mean
829943|NCT01234207|Primary|30-degree Off-axis Distance Visual Acuity, Low Contrast Chart|Measured with subject immobilized in specially designed apparatus, keeping head pointed straight forward and moving only the eyes to left or right to view the off-axis chart|Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles|95 presbyopic subjects wearing standard, non-free-form, non-customized PAL spectacles for 1 week, and individually customized, free-form surfaced PAL spectacles for 1 week, in randomized order, with a 1-week washout period||logMAR||Standard Deviation|Mean
829978|NCT01234714|Secondary|Intra-operative Blood Loss|Intra-operative blood loss was defined according to the total volume of blood loss from the beginning until the end of the operation.|December 2010|According to MRI||ml||Inter-Quartile Range|Median
839185|NCT01324622|Primary|Sagittal Angle Success|Success defined as ≤ +15º (kyphosis) as indicated by a neutral lateral radiograph|12 months|Number of subjects with radiographic data available at 12 month visit||participants|||Number
829944|NCT01234207|Primary|30-degree Off-axis Distance Visual Acuity, High Contrast Chart|Measured with subject immobilized in specially designed apparatus, keeping head pointed straight forward and moving only the eyes to left or right to view the off-axis chart|Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles|95 presbyopic subjects wearing standard, non-free-form, non-customized PAL spectacles for 1 week, and individually customized, free-form surfaced PAL spectacles for 1 week, in randomized order, with a 1-week washout period||logMAR||Standard Deviation|Mean
829945|NCT01234207|Primary|Visual Acuity, Low Contrast, Near Chart|Standard assessment of low contrast visual acuity at near, as in normal clinical practice, using Baily-Lovey charts and the M&S Technologies Smart System II visual acuity projection system.|Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles|95 presbyopic subjects wearing standard, non-free-form, non-customized PAL spectacles for 1 week, and individually customized, free-form surfaced PAL spectacles for 1 week, in randomized order, with a 1-week washout period||logMAR||Standard Deviation|Mean
829946|NCT01234207|Primary|Visual Acuity, High Contrast, Near Chart|Standard assessment of high contrast visual acuity at near, as in normal clinical practice, using Baily-Lovey charts and the M&S Technologies Smart System II visual acuity projection system.|Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles|95 presbyopic subjects wearing standard, non-free-form, non-customized PAL spectacles for 1 week, and individually customized, free-form surfaced PAL spectacles for 1 week, in randomized order, with a 1-week washout period||logMAR||Standard Deviation|Mean
829947|NCT01234207|Primary|Visual Acuity, Low Contrast, Distance Chart|Standard assessment of low contrast visual acuity at distance, as in normal clinical practice, using Baily-Lovey charts and the M&S Technologies Smart System II visual acuity projection system.|Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles|95 presbyopic subjects wearing standard, non-free-form, non-customized PAL spectacles for 1 week, and individually customized, free-form surfaced PAL spectacles for 1 week, in randomized order, with a 1-week washout period||logMAR||Standard Deviation|Mean
829948|NCT01234207|Primary|Visual Acuity, High Contrast, Distance Chart|Standard assessment of high contrast visual acuity at distance, as in normal clinical practice, using Baily-Lovey charts and the M&S Technologies Smart System II visual acuity projection system.|Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles|95 presbyopic subjects wearing standard, non-free-form, non-customized PAL spectacles for 1 week, and individually customized, free-form surfaced PAL spectacles for 1 week, in randomized order, with a 1-week washout period||logMAR||Standard Deviation|Mean
829949|NCT01234337|Other Pre-specified|Number of Participants With Treatment-emergent Grade 3 and 4 Laboratory Abnormalities|Hematological (anemia, hemoglobin, international normalized ratio [INR], lymphocyte, neutrophil, platelet, white blood cell [WBC]), biochemical (ALT [alanine aminotransferase], AST [aspartate aminotransferase], GGT [gamma-glutamyl-transferase], lipase, hypoalbuminemia, hypocalcemia, hyperglycemia, hyperuricemia) evaluations were done. Common terminology criteria for adverse events (CTCAE) version 4-Grade 3: Severe or medically significant; hospitalization or prolongation of hospitalization and CTCAE version 4-Grade 4: life-threatening consequences; urgent intervention were indicated.|From the start of study treatment up to 30 days after the last dose|Safety Analysis Set (SAF) was comprised of all randomized participants who received at least one dose of study medication (sorafenib, placebo or capecitabine). Participants were analyzed as treated.||Paricipants|||Number
829950|NCT01234337|Other Pre-specified|Area Under Curve From Time Zero to Last Quantifiable Concentration (AUC[0-tlast]) of Capecitabine and 5-fluorouracil|AUC(0-tlast) is defined as AUC from time 0 to the last data point, calculated up by linear trapezoidal rule, down by logarithmic trapezoidal rule. Geometric mean and percentage geometric coefficient of variation (%CV) were reported. In the listed categories below, 'N' signifies the number of evaluable participants for the drug administered.|Pre-dose and 0.5, 1, 2, and 4 hours after capecitabine dosing at Cycle 2, Day 14|PKS||milligram*hour per liter||Geometric Coefficient of Variation|Geometric Mean
829951|NCT01234337|Other Pre-specified|Maximum Observed Drug Concentration (Cmax) of Capecitabine and 5-fluorouracil|Maximum observed drug concentration, directly taken from analytical data. Geometric mean and percentage geometric coefficient of variation (%CV) were reported. In the listed categories below, 'N' signifies the number of evaluable participants for the drug administered.|Pre-dose and 0.5, 1, 2, and 4 hours after capecitabine dosing at Cycle 2, Day 14|Pharmacokinetic Analysis Set (PKS) included all participants with a valid pharmacokinetic profile of capecitabine.||milligram per liter||Geometric Coefficient of Variation|Geometric Mean
829952|NCT01234337|Other Pre-specified|Patient Reported Outcomes: Euroqol-5 Dimensions (EQ-5D) - Visual Analogue Scale (VAS) Score|The EQ-5D was a generic QoL preference based instrument and has been validated in the cancer populations. VAS was generated from 0 (worst imaginable health state) to 100 (best imaginable health state). This VAS score was referred to as the EQ-5D self-reported health status score. The results on ANCOVA of time-adjusted AUC were reported. The time-adjusted AUC was calculated by dividing the AUC by duration (in days) over the period of interest, and reported as 'scores on a scale'.|Day 1 of Cycles 1, 3, 5, 7, 9, 11, 13, 16, 19, 22, 25, 28, and EOT (21 days after last dose of study drug)|FAS participants with a baseline assessment and at least one post-baseline assessment during the study.||Scores on a scale||95% Confidence Interval|Least Squares Mean
829953|NCT01234337|Other Pre-specified|Patient Reported Outcomes: Euroqol-5 Dimensions (EQ-5D) - Index Score|The EQ-5D was a generic Quality of life (QoL) based instrument validated in cancer populations. EQ-5D questionnaire contained a 5-item descriptive system of health states (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and visual analogue scale (VAS). A single HRQoL score ranging from -0.59 to 1 was generated from standard scoring algorithm developed by the EuroQoL was the EQ-5D index score, higher scores represent better health status. A change of at least 0.10 to 0.12 points was considered clinically meaningful. The results on the ANCOVA of time-adjusted AUC for the EQ-5D - Index Score were reported. The time-adjusted AUC was calculated by dividing the AUC by duration (in days) over the period of interest, and reported as 'scores on a scale'.|Day 1 of Cycles 1, 3, 5, 7, 9, 11, 13, 16, 19, 22, 25, 28, and EOT (21 days after last dose of study drug)|FAS participants with a baseline assessment and at least one post-baseline assessment during the study.||Scores on a scale||95% Confidence Interval|Least Squares Mean
829979|NCT01234714|Secondary|Post-operative Alanine Transaminase (ALT) Levels|Alanine Transaminase is commonly measured clinically as a part of a diagnostic evaluation of hepatocellular injury, to determine liver health.|December 2010|According to the MRI liver fat content measurement.||Units/liter||Inter-Quartile Range|Median
829954|NCT01234337|Other Pre-specified|Patient Reported Outcomes: Functional Assessment of Cancer Therapy-Breast Symptom Index (8 Item) (FBSI-8)|The FBSI-8 was an 8-item questionnaire. Participants responded to each item using a 5-point Likert-type scale ranging from 0 (not at all) to 4 (very much). A total scale score was calculated (range from 0 to 32), with higher scores indicating low symptomatology and reflecting a better Health-Related Quality of Life (HRQoL). The results on the analysis of covariance (ANCOVA) of time-adjusted area under curve (AUC) for the FBSI-8 score were reported. The time-adjusted AUC was calculated by dividing the AUC by duration (in days) over the period of interest, and reported as 'scores on a scale'.|Day 1 of Cycles 1, 3, 5, 7, 9, 11, 13, 16, 19, 22, 25, 28, 31, 34, 37, and end of treatment (EOT, 21 days after last dose of study drug)|FAS participants with a baseline assessment and at least one post-baseline assessment during the study.||Scores on a scale||95% Confidence Interval|Least Squares Mean
829955|NCT01234337|Secondary|Duration of Response (DOR) by Central Reader|DOR was defined as the time from date of first response (CR or PR) to the date when PD is first documented, or to the date of death, whichever occurred first according to RECIST version 1.1. CR=all target lesions disappeared, and any pathological lymph node, whether target or non-target, had a reduction in short axis to <10 mm. If any residual lesion was present, cyto-histology was made available to unequivocally document benignity. PR=at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Participants still having CR or PR and have not died at the time of analysis were censored at their last date of tumor evaluation. DOR defined for confirmed responders only (that is, CR or PR). 'NA' indicates that value could not be estimated due to censored data. Median and 95% CIs were computed using Kaplan-Meier estimates.|From randomization of the first participant until approximately 3 years later or until disease radiological progression|Only responders in FAS were evaluated for this outcome measure.||days||95% Confidence Interval|Median
829956|NCT01234337|Secondary|Disease Control Rate (DCR) by Central Review|DCR was defined as the proportion of participants whose best response was CR, PR, stable disease (SD) or Non-CR/Non-PD. Per RECIST version 1.1, CR=all target lesions disappeared, any pathological lymph node, target/non-target, a reduction in short axis to <10 mm. PR=at least 30% decrease in the sum of diameters of target lesions taking as reference baseline sum diameters. PD=at least 20% increase in the sum of diameters of the target lesions, taking as a reference smallest sum on study. Appearance of new lesions and unequivocal progression of existing non-target lesions. SD=neither sufficient shrinkage qualified for PR nor sufficient increase qualified for PD, taking smallest sum of diameters as a reference. Non-CR/Non-PD=persistence of 1/more non-target lesion(s) and/or maintenance of tumor marker level above normal limits. DCR=CR+PR+SD or Non-CR/Non-PD. CR and PR confirmed by another scan at least 4 weeks later. SD and Non-CR/Non-PD documented at least 6 weeks after randomization.|From randomization of the first participant until approximately 3 years later or until disease radiological progression|FAS||percentage (%) of participants||95% Confidence Interval|Number
829957|NCT01234337|Secondary|Objective Response Rate (ORR) by Central Review|ORR was defined as the best tumor response (Complete Response [CR] or Partial Response [PR]) observed during treatment or within 30 days after termination of study treatment, assessed according to the RECIST version 1.1. CR=all target lesions disappeared, and any pathological lymph node, whether target or non-target, had a reduction in short axis to <10 mm. If any residual lesion was present, cyto-histology was made available to unequivocally document benignity. PR=at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR=CR+PR. CR and PR were confirmed by another scan at least 4 weeks later.|From randomization of the first participant until approximately 3 years later or until disease radiological progression|FAS||Percentage (%) of participants||95% Confidence Interval|Number
829958|NCT01234337|Secondary|Time to Progression (TTP) by Central Review|TTP was defined as the time from date of randomization to disease radiological progression by central review. Per RECIST version 1.1, progressive disease was determined when there was at least 20% increase in the sum of diameters of the target lesions, taking as a reference the smallest sum on study (this included the baseline sum if that was the smallest sum on trial). In addition to a relative increase of 20%, the sum had demonstrated an absolute increase of at least 5 mm. Appearance of new lesions and unequivocal progression of existing non-target lesions was also interpreted as progressive disease. Participants without progression or death at the time of analysis were censored at their last date of evaluable tumor evaluation. Median and other 95% confidence intervals (CIs) computed using Kaplan-Meier estimates.|From randomization of the first participant until approximately 3 years later or until disease radiological progression|FAS||days||95% Confidence Interval|Median
829959|NCT01234337|Secondary|Overall Survival (OS)|OS was defined as the time from date of randomization to death due to any cause. Participants still alive at the time of analysis were censored at their last known alive date. Median and other 95% CIs computed using Kaplan-Meier estimates.|From randomization of the first participant until approximately 3 years later|FAS||days||95% Confidence Interval|Median
829960|NCT01234337|Primary|Progression-free Survival (PFS) Assessed by the Independent Review Panel According to Response Evaluation Criteria for Solid Tumors (RECIST) 1.1|PFS was defined as the time from date of randomization to disease progression, radiological or death due to any cause, whichever occurs first. Per RECIST version 1.1, progressive disease was determined when there was at least 20% increase in the sum of diameters of the target lesions, taking as a reference the smallest sum on study (this included the baseline sum if that was the smallest sum on trial). In addition to a relative increase of 20%, the sum had demonstrated an absolute increase of at least 5 mm. Appearance of new lesions and unequivocal progression of existing non-target lesions was also interpreted as progressive disease. Participants without progression or death at the time of analysis were censored at their last date of evaluable tumor evaluation. Median and other 95% confidence intervals (CIs) computed using Kaplan-Meier estimates.|From randomization of the first participant until approximately 3 years or until disease radiological progression|Full Analysis Set (FAS), also considered as Intent-to-treat (ITT) set, was defined as all randomized participants even if randomized but received no drug or if randomized and initially received incorrect drug prior to switching to correct study drug, these were included in FAS.||days||95% Confidence Interval|Median
829995|NCT01235195|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose|All participants.||ng*h/mL||Standard Deviation|Mean
829961|NCT01234467|Secondary|Evaluate the Toxicity and Tolerability of Bendamustine in Combination With Rituximab|The major grade 3 or higher adverse events were haematological toxicities. The results below include common haematological and non-haematological toxicities of grade 3 or higher. A complete record of all adverse events are reported in the adverse events section. National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0 were used to assess toxicity.|Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.|This represents the data after inclusion of the first 23 patients at the planned interim analysis. The data analysis was performed prior to the previously determined 3-year follow-up period because the study did not reach the initially planned sample size to determine the survival rates in a statistically significant manner as secondary objectives.||percentage of patients|||Number
829962|NCT01234467|Secondary|Overall Survival|This represents the Kaplan-Meier estimates of median overall survival defined as the time from start of treatment until death as a result of any cause.|2 years with the median follow-up of 29 months|This represents the data after inclusion of the first 23 patients at the planned interim analysis. The data analysis was performed prior to the previously determined 3-year follow-up period because the study did not reach the initially planned sample size to determine the survival rates in a statistically significant manner as secondary objectives.||Months||95% Confidence Interval|Median
829963|NCT01234467|Secondary|Estimate of Progression-Free Survival|Progression-free survival (PFS) will be summarized using the Kaplan-Meier method. PFS was defined as the time from the start of treatment until lymphoma progression or death as a result of any cause. Progression was defined by The International Harmonization Project for Response Criteria as any new lesion or increase by ≥50% of previously involved sites from nadir.|2 years with the median follow-up of 29 months|This represents the data after inclusion of the first 23 patients at the planned interim analysis. The data analysis was performed prior to the previously determined 3-year follow-up period because the study did not reach the initially planned sample size to determine the survival rates in a statistically significant manner as secondary objectives.||Months||95% Confidence Interval|Median
829964|NCT01234467|Secondary|Partial Response Rate|The percentage of participants achieving a partial response (PR). PR is defined by The International Harmonization Project for Response Criteria as regression of measurable disease and no new sites.|2 years|This represents the data after inclusion of the first 23 patients at the planned interim analysis. The data analysis was performed prior to the previously determined 3-year follow-up period because the study did not reach the initially planned sample size to determine the survival rates in a statistically significant manner as secondary objectives.||percentage of participants||95% Confidence Interval|Number
829965|NCT01234467|Secondary|Overall Response Rate (ORR)|The ORR consists of the complete response rate + the partial response rate (percentage of participants achieving a complete or partial response). Complete response is defined by The International Harmonization Project for Response Criteria as the complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. Partial response is defined as regression of measurable disease and no new sites.|2 years|This represents the data after inclusion of the first 23 patients at the planned interim analysis. The data analysis was performed prior to the previously determined 3-year follow-up period because the study did not reach the initially planned sample size to determine the survival rates in a statistically significant manner as secondary objectives.||percentage of participants|||Number
829966|NCT01234467|Primary|Complete Response (CR) Rate as Defined by The International Harmonization Project for Response Criteria|Complete response (CR) is defined as the complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. The complete response rate is the percentage of participants achieving a CR.|2 years|This represents the data after inclusion of the first 23 patients at the planned interim analysis. The data analysis was performed prior to the previously determined 3-year follow-up period because the study did not reach the initially planned sample size to determine the survival rates in a statistically significant manner as secondary objectives.||percentage of participants||95% Confidence Interval|Number
829967|NCT01234675|Primary|Percentage of Total Sleep Time|Sleep measures at week 5 of the treatment period I; and upto week 12 for treatment period II Percentage of Total Sleep Time that was spent in various stages of sleep|Overnight PSG week 5/ up to week 12; milnacipran treatment|||Percent of total sleep time||Standard Error|Mean
829968|NCT01234675|Primary|Arousal Index|Number of arousal per hours|Overnight PSG week 5/ upto week 12; milnacipran treatment|||Number of Arousals per hour||Standard Error|Mean
829969|NCT01234675|Primary|Sleep Efficiency|Percentage of Total sleep time|Overnight PSG week 5/ upto week 12; milnacipran treatment|||Percentage of total sleep time||Standard Error|Mean
829970|NCT01234675|Primary|Number of Awakenings After Sleep Onset||Overnight PSG week 5/ upto week 12; milnacipran treatment|||Number of Awakenings||Standard Error|Mean
829971|NCT01234675|Secondary|Subjective Measures With Change in Sleep and Change in Pain Measures|"Subjective assessments will constitute secondary endpoints and will include:
• Clinical Global Impression Improvement of Illness Scale (CGI-I) Clinical Global Impression- Severity of Illness scale (CGI-S); Medical Outcomes study Sleep Scale (MOS-SS); Fibromyalgia impact questionnaire (FIQ); Brief Pain Inventory (BPI) score-short form; Patient Global Impression of change (PGI-C); Beck Depression Inventory (BDI; Fatigue Severity Scale (FSS; Numeric Rating Scale-Sleep (NRS-S), part of subjective sleep questionnaire"|assessments made at week 1, week 6, week 14||||||
829972|NCT01234675|Primary|Overnight Polysomnography to Measure Sleep Disturbance With Milnacipran Treatment|Sleep measures at week 5 of the treatment period I; and upto week 12 for treatment period II|Overnight PSG week 5/ up to week 12; milnacipran treatment|||minutes||Standard Error|Mean
829973|NCT01234714|Secondary|Type of Post-operative Complications|There are several different types of post-operative complications associated with liver surgery, such as liver failure, multi-organ failure, bleeding, bile leak, and sepsis.|December 2010||||||
829974|NCT01234714|Secondary|Cost|The total in-hospital costs were calculated for each patient in Euros.|December 2010|According to MRI||Euros||Standard Deviation|Mean
829975|NCT01234714|Secondary|Hospital Stay|The patient hospital stay was calculated according to the total number of days the patient was hospitalized.|December 2010|According to MRI||days||Inter-Quartile Range|Median
829976|NCT01234714|Secondary|Intensive Care Unit (ICU) Stay|The Intensive Care Unit (ICU) stay was calculated according to the total number of days the patients were managed in the ICU. This included also multiple ICU admissions.|December 2010|According to MRI||days||Inter-Quartile Range|Median
829980|NCT01234714|Primary|Percentage of Liver Fat Content on MRI in Patients With Serious Post-operative Complications (Clavien-Dindo Grade ≥IV)|"Liver fat content, measured by MRI, uses the in-phase/out-of-phase imaging calculated in terms of fat signal fraction (FSF).
The Clavien-Dindo Classification of Surgical Complications:
Grade I: Any deviation from the normal postoperative course without the need for treatment. Grade II: Requiring pharmacological treatment with drugs. Grade III: Requiring surgical, endoscopic or radiological intervention. Grade IV: Life-threatening complication requiring IC/ICU-management. Grade V: Death of a patient"|December 2010|According to the Clavien-Dindo Classification of surgical complications: (please see) http://www.surgicalcomplication.info/||Percentage of liver fat content||Inter-Quartile Range|Median
829988|NCT01234870|Secondary|Number of Participants With Adverse Events to Demonstrate Feasibility of a Comprehensive Cardiac Magnetic Resonance Imaging Protocol|Adverse events relating to administration of adenosine during a coronary heart disease comprehensive cardiac MRI study.|14 days|||occurances of adverse events|||Number
829989|NCT01234870|Primary|Magnetic Resonance Image Quality Rating|The purpose of the study is to assess the incremental value of diagnostic performance using a fully-automated, motion-corrected (MC) first pass myocardial perfusion image acquisition protocol compared to images obtained under a non-corrected, breath-hold, shallow-breathing first pass myocardial perfusion image acquisition protocol in patients with suspected ischemic heart disease. The MR images resulting from two different image acquisition techniques, including Non-Corrected Breath-Hold Shallow-Breathing and Motion-Corrected, were assessed independently by two radiologists (average of 7 years of experience in reading cardiac MRI) using the American Heart Association modified 16 segment model and were evaluated using a four point Likert scale (1 = poor, 2 = fair, 3 = good, and 4 = excellent) for image quality|Cross sectional study; magnetic resonance images were obtained on all patients using two different acquisition methods.|||units on a likert scale||Standard Deviation|Mean
829990|NCT01234883|Primary|Venous Serum Bicarbonate: Modified Intent to Treat Population (mITT); Obtained at Hour 4|The primary efficacy variable was venous serum bicarbonate (marker of metabolic acidosis) at Hour 4 (+/- 1 hour) from the start of the First IV Bolus at Hour 0.|4 hour|The mITT population is all subjects with Baseline bicarbonate value ≤ 22 mmol/L. The mITT population was used for efficacy evaluation. The AT analysis set was defined as all subjects who received at least 5 mL of study treatment and were classified according to actual treatment received. AT population was used for AE analysis.||mmol/L||Standard Deviation|Mean
829991|NCT01234922|Secondary|Change in Ang II, VEGF, PlGF, and ACE Levels||1 week||||||
829992|NCT01234922|Primary|Changes in Ang1-7 Levels Among Patients After ACE-I/ARB Treatment Measured in Picogram/Milliliter||7 days post-baseline|||Picogram/milliliter||Standard Deviation|Mean
829993|NCT01235195|Secondary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose|All participants.||hours||Standard Deviation|Mean
829994|NCT01235195|Secondary|Residual Area Under the Concentration Time Curve [AUC(Res%)]|AUC(res%) is the residual AUC defined as (AUCinf minus AUClast) divided by AUCinf. AUCinf is the area under the plasma concentration-time curve from time zero extrapolated to infinite time. AUClast is the area under the plasma concentration-time curve from zero to the last measured concentration.|Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose|This parameter was not analyzed. It is reported individually for each subject and not analyzed statistically.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
829996|NCT01235195|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose|All participants.||hours||Full Range|Median
829998|NCT01235195|Primary|Area Under the Curve From Time Zero to 72 Hours [AUC (0-72)]|AUC (0-72)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 72 hours (0-72).|Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose|All participants: all treated participants with at least one sertraline concentration were evaluated for pharmacokinetics.||nanogram hour per milliliter (ng*h/mL)||Standard Deviation|Mean
829999|NCT01235234|Secondary|Ocular Surface Disease Index|Change from Baseline in Ocular Surface Disease Indexat Week 24|24 weeks||||||
830000|NCT01235234|Secondary|Increase in Schirmer Test Tearing by >9mm Over Baseline|Proportion of subjects with ST wetting increase over Baseline of ≥10 mm with or without anesthesia in either eye at Week 24|24 weeks||||||
830001|NCT01235234|Primary|Nature and Frequency of Adverse Events|The primary efficacy comparison with respect to the rates of complete clearing of corneal staining at Week 24 was performed using a 2-sided test at level 0.025 to adjust for the comparison of 2 doses of CF101 to placebo. All between-treatment comparisons with respect to all secondary efficacy endpoints were performed using 2-sided tests at level 0.025. Between-treatment comparisons with respect to ancillary efficacy endpoints were performed using 2-sided tests at level 0.05. The primary comparison, as well as the comparisons with respect to the proportion of subjects with complete central corneal clearing (i.e., central corneal FS score=0) in the target eye and the proportion of subjects with ST ≥10 mm with or without anesthesia in either eye, was performed using the Cochran-Mantel-Haenszel test, stratified by duration of symptoms at Baseline (≤5 years or>5 years) and disease severity at Baseline (ST1-3or4-6 mm/5 minutes without anesthesia).|24 weeks||||||
830002|NCT01235234|Primary|Efficacy by Proportion of Subjects Who Achieved Complete Clearing of Corneal Staining (i.e., Total Corneal FS Score = 0) at Week 24|Complete clearing of corneal staining by fluorescein staining (FS). The primary efficacy analysis was performed for 1eye (target eye), defined as the eye with the larger corneal FS value at Baseline. If both eyes had the same corneal FS value at baseline, the target eye was considered the eye with the larger central corneal staining value at Baseline. Corneal FS defined as a corneal punctate fluorescein staining score of ≥4 in either eye by the National Eye Institute evaluation scale summed over 5 areas each with a 0-3 scoring scale|24 weeks|||participants|||Number
830003|NCT01235338|Secondary|Pulse Rate||Baseline and up to 39 days|SAS||bpm||Standard Deviation|Mean
830004|NCT01235338|Primary|Tmax of Composite (Venlafaxine + o-Desmethylvenlafaxine)||Day 15 and Day 30 (24 hour sampling)|PAS||hours||Standard Deviation|Mean
830005|NCT01235338|Primary|Tmax of o-Desmethylvenlafaxine||Day 15 and Day 30 (24 hour sampling)|PAS||hours||Standard Deviation|Mean
830006|NCT01235338|Primary|Tmax of Venlafaxine Hydrochloride||Day 15 and Day 30 (24 hour sampling)|PAS||hours||Standard Deviation|Mean
830007|NCT01235338|Primary|Tmax of d-Amphetamine||Day 15 and Day 30 (24 hour sampling)|PAS||hours||Standard Deviation|Mean
830008|NCT01235338|Primary|Time of Maximum Plasma Concentration (Tmax) of Lisdexamfetamine Dimesylate||Day 15 and Day 30 (24 hour sampling)|PAS||hours||Standard Deviation|Mean
830009|NCT01235338|Primary|AUC of Composite (Venlafaxine + o-Desmethylvenlafaxine)||Day 15 and Day 30 (24 hour sampling)|PAS||ng*hr/ml||Standard Deviation|Mean
830010|NCT01235338|Primary|AUC of o-Desmethylvenlafaxine||Day 15 and Day 30 (24 hour sampling)|PAS||ng*hr/ml||Standard Deviation|Mean
830011|NCT01235338|Primary|AUC of Venlafaxine Hydrochloride||Day 15 and Day 30 (24 hour sampling)|PAS||ng*hr/ml||Standard Deviation|Mean
830012|NCT01235338|Primary|AUC of d-Amphetamine||Day 15 and Day 30 (24 hour sampling)|PAS||ng*hr/ml||Standard Deviation|Mean
830013|NCT01235338|Primary|Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate||Day 15 and Day 30 (24 hour sampling)|PAS||ng*hr/ml||Standard Deviation|Mean
830014|NCT01235338|Primary|Cmax of Composite (Venlafaxine + o-Desmethylvenlafaxine)||Day 15 and Day 30 (24 hour sampling)|PAS||ng/ml||Standard Deviation|Mean
830015|NCT01235338|Primary|Cmax of o-Desmethylvenlafaxine|Venlafaxine, after oral administration, is metabolized in the liver to an active metabolite, o-Desmethylvenlafaxine.|Day 15 and Day 30 (24 hour sampling)|PAS||ng/ml||Standard Deviation|Mean
830016|NCT01235338|Secondary|Diastolic Blood Pressure||Baseline and up to 39 days|SAS||mmHg||Standard Deviation|Mean
830017|NCT01235338|Secondary|Systolic Blood Pressure||Baseline and up to 39 days|Safety Analysis Set (SAS) defined as all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||mmHg||Standard Deviation|Mean
830018|NCT01235338|Primary|Cmax of Venlafaxine Hydrochloride|Venlafaxine Hydrochloride is the active ingredient of Effexor XR|Day 15 and Day 30 (24 hour sampling)|PAS||ng/ml||Standard Deviation|Mean
830019|NCT01235338|Primary|Cmax of d-Amphetamine|d-Amphetamine is the active isomer of Lisdexamfetamine dimesylate (SPD489) and is responsible for the drug's therapeutic activity.|Day 15 and Day 30 (24 hour sampling)|PAS||ng/ml||Standard Deviation|Mean
830020|NCT01235338|Primary|Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (SPD489) itself is inactive, but following oral administration is converted to the active isomer, d-amphetamine, that is responsible for the drug's therapeutic activity.|Day 15 and Day 30 (24 hour sampling)|Pharmacokinetic Analysis Set (PAS) defined as all subjects who took a t least 1 dose of investigational product and had at least 1 post-dose safety assessment and who had no major deviations related to investigational product intake (e.g. vomiting) and for whom the primary pharmacokinetic data were considered sufficient and interpretable.||ng/ml||Standard Deviation|Mean
830021|NCT01235377|Secondary|Factors Associated With Prescribing Patterns|factors (barriers and facilitators) associated with prescribing according to the Cluster Designation|nine months||||||
830022|NCT01235377|Primary|Prescription Rates|rates of provider prescribing of the Cluster Designated drug|nine months|providers prescribing a thiazide at least once in the study period||% new thiazide prescriptions||Inter-Quartile Range|Median
830023|NCT01235403|Secondary|Percentage of Subjects Retained on Vimpat Through the End of the 24-week Treatment Period|"The number of subjects continuing on Vimpat up to and including Visit 4 (Week 24) divided by the number of patients who took at least 1 dose of Vimpat multiplied by 100.
The overall Treatment Period comprises of a 12-week Titration Phase and 12-week Maintenance Phase."|End of Treatment Period (24-week)|Safety Set||percentage of subjects|||Number
830835|NCT01240200|Primary|Treatment Satisfaction Based on Patient Survey|The primary outcome of the study is to determine differences in treatment satisfaction scores in elderly patients with diabetes treated with basal insulin delivered via a pen device versus a syringe.|at 0 weeks||||||
830024|NCT01235403|Primary|Number of Subjects Prematurely Discontinuing Due to a TEAE During the Study|Number of subjects prematurely discontinuing due to a TEAE during the study. The study is comprised of a 12-week Titration Phase, a 12 -week Maintenance Phase, and a 3 to 4 week Taper Phase if needed.|During the study (up to 24 - 28 weeks)|Safety Set||subjects|||Number
830025|NCT01235403|Primary|Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Study|Number of subjects reporting at least 1 Treatment-Emergent Adverse Event (TEAE) during the study. The study is comprised of a 12-week Titration Phase, a 12 -week Maintenance Phase, and a 3 to 4 week Taper Phase if needed.|During the study ( up to 24 - 28 weeks)|Safety Set||subjects|||Number
830026|NCT01235442|Secondary|sPGA (0,1) at Week 24|The percentage of participants achieving sPGA 0 or 1 at week 24. Static physician global assessment of psoriasis (sPGA) is a physician’s global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The sPGA of psoriasis comprises a 6-point scale ranging from 0 (clear) to 5 with increasing severity.|Week 24|Intention-to-Treat with last observation carried forward (LOCF) imputation||Percentage of participants|||Number
830027|NCT01235442|Secondary|PASI 75 at Week 24|The percentage of participants with the Psoriasis Area and Severity Indexs (PASI) 75 responses at week 24. PASI is an assessment of psoriasis based on severity of erythema, infiltration, and desquamation as well as area of involvement. The PASI score ranges from 0 to 72. The higher score represents the worse symptom severity. A response was considered a 75% reduction in the PASI score from Baseline.|Week 24|Intention-to-Treat with last observation carried forward (LOCF) imputation||Percentage of participants|||Number
830028|NCT01235442|Secondary|Percent PASI Improvement From Baseline at Week 12|The percentage of the improvement in PASI score at week 12 from baseline. PASI is an assessment of psoriasis based on severity of erythema, infiltration, and desquamation as well as area of involvement. The PASI score ranges from 0 to 72. The higher score represents the worse symptom severity.|Week 12|Intention-to-Treat with last observation carried forward (LOCF) imputation||Percentage of Improvement in PASI score||Standard Deviation|Mean
830029|NCT01235442|Secondary|Patient Satisfaction at Week 12|Patient assessment of treatment satisfaction status at week 12. It is a measure of a participant's level of satisfaction with the medication’s control of psoriasis, ranging from “very satisfied” to “very dissatisfied.”|Week 12|PRO analysis set, including all subjects randomized and also complete the baseline and at least 1 of the post-baseline PRO assessment with last observation carried forward (LOCF) imputation||Percentage of participants|||Number
830030|NCT01235442|Secondary|PASI 90 at Week 12|The percentage of participants with the Psoriasis Area and Severity Indexs (PASI) 90 responses at week 12. PASI is an assessment of psoriasis based on severity of erythema, infiltration, and desquamation as well as area of involvement. The PASI score ranges from 0 to 72. The higher score represents the worse symptom severity. A response was considered a 90% reduction in the PASI score from Baseline.|Week 12|Intention-to-Treat with last observation carried forward (LOCF) imputation||Percentage of participants|||Number
830031|NCT01235442|Secondary|sPGA (0,1) at Week 12|The percentage of participants achieving sPGA 0 or 1 at week 12. Static physician global assessment of psoriasis (sPGA) is a physician’s global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The sPGA of psoriasis comprises a 6-point scale ranging from 0 (clear) to 5 with increasing severity.|Week 12|Intention-to-Treat with last observation carried forward (LOCF) imputation||Percentage of participants|||Number
830032|NCT01235442|Primary|PASI 75 at Week 12|The percentage of participants with the Psoriasis Area and Severity Indexs (PASI) 75 responses at week 12. PASI is an assessment of psoriasis based on severity of erythema, infiltration, and desquamation as well as area of involvement. The PASI score ranges from 0 to 72. The higher score represents the worse symptom severity. A response was considered a 75% reduction in the PASI score from Baseline.|Week 12|Intention-to-Treat with last observation carried forward (LOCF) imputation||Percentage of participants|||Number
830033|NCT01235507|Primary|Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs)|AEs, SAEs and AESI were recorded from the Screening Visit until the final visit at Week 24.|Screening Visit, Baseline, Weeks 4, 8, 12, 16, 20 and 24|Safety Analysis Population: All participants enrolled in the study who received at least 1 dose of study medication and had at least 1 post-baseline assessment of safety (such as laboratory data, vital signs, or AEs) were included.||percentage of participants|||Number
830034|NCT01235507|Secondary|Erythrocyte Sedimentation Rate (ESR)|ESR is a marker of inflammation and is measured in millimeters per hour (mm/hour). A negative change from baseline represents an improvement.|Baseline, Weeks 8, 16 and 24|ITT Population; n=number of participants analyzed for the given parameter at the specified time point||mm/hour||Standard Deviation|Mean
830035|NCT01235507|Secondary|CRP Levels|CRP is a marker of acute phase inflammation and is measured in mg/L. A negative change from baseline represents an improvement.|Baseline, Weeks 8, 16 and 24|ITT Population; n=number of participants analyzed for the given parameter at the specified time point||mg/L||Standard Deviation|Mean
830036|NCT01235507|Secondary|Participant's Global Assessment of Pain|Participant's global assessment of pain was performed using a 100 mm VAS ranging from no pain (0) at the left edge to unbearable pain (100) at the right edge. The distance in mm from the left edge of the scale was measured. A negative change from baseline represents an improvement.|Baseline, Weeks 8, 16 and 24|ITT Population; n=number of participants analyzed for the given parameter at the specified time point||mm||Standard Deviation|Mean
830037|NCT01235507|Secondary|Participant's Global Assessment of Disease Activity|Participant's global assessment of disease activity was performed using a 100 mm VAS ranging from no arthritis activity (0) to maximal arthritis activity (100). The distance in mm from the left edge of the scale was measured. Higher scores indicated higher disease activity. A negative change from baseline represents an improvement.|Baseline, Weeks 8, 16 and 24|ITT Population; n=number of participants analyzed for the given parameter at the specified time point||mm||Standard Deviation|Mean
830038|NCT01235507|Secondary|Physician's Global Assessment of Disease Activity|Physician's global assessment of disease activity was performed using a 100 mm VAS ranging from no arthritis activity (0) to maximal arthritis activity (100). The distance in mm from the left edge of the scale was measured. Higher scores indicated higher disease activity. A negative change from baseline represents an improvement.|Baseline, Weeks 8, 16 and 24|ITT Population; n=number of participants analyzed for the given parameter at the specified time point||mm||Standard Deviation|Mean
830039|NCT01235507|Secondary|Swollen and Tender Joint Counts|66 and 68 joints were assessed by the physician for tenderness or swelling respectively. The joints were counted as tender/not tender (tender=1; not tender=0) and swollen/not swollen (swollen=1; not swollen=0) and scored. The scores ranged from 0 to 66 for TJC and 0 to 68 for SJC. A negative change from baseline represents an improvement.|Baseline, Weeks 8, 16 and 24|ITT Population; n= number of participants analyzed for the given parameter at the specified time point||Joints||Standard Deviation|Mean
830040|NCT01235507|Secondary|Percentage of Participants Achieving Low Disease Activity (LDA) and Clinical Remission (CR) as Assessed Using DAS28|"DAS28 was calculated using the 28 joints count, the CRP and PtGA of disease activity. The following formula was used to determine DAS28.
DAS28 = 0.56 × √(TJC28) + 0.28 × √(SJC28) + 0.36 × ln(CRP+1) + 0.014 × GH + 0.96 where, TJC28 = tender joint count on 28 joints, SJC28 = swollen joint count on 28 joints, ln = natural log, CRP = C-reactive protein (mg/L), and GH = general health, determined by participant's global assessment of disease activity (100-mm VAS).
The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. Participants were considered to have low disease activity when DAS28 was less than or equal to (≤) 3.2 and in clinical remission when DAS28 scores were less than (<) 2.6"|Weeks 8, 16 and 24|ITT Population; n= number of participants analyzed for the given parameter at the specified time point||percentage of participants|||Number
830041|NCT01235507|Secondary|Mean Disease Activity Score Based on 28 Joint Count (DAS28) by Visit|"DAS28 was calculated using the 28 joints count, the C-reactive protein levels (CRP) and participant's global assessment (PtGA) of disease activity. The following formula was used to determine DAS28.
DAS28 (equals) = 0.56 × (square root of) √(TJC28) + 0.28 × √(SJC28) + 0.36 × ln(CRP+1) + 0.014 × GH + 0.96 where, TJC28 = tender joint count on 28 joints, SJC28 = swollen joint count on 28 joints, ln = natural log, CRP = C-reactive protein (mg/L), and GH = general health, determined by participant's global assessment of disease activity (100- millimeter [mm] visual analog scale [ VAS]).
The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity."|Baseline, Weeks 8, 16 and 24|ITT Population; number (n) = number of participants analyzed for the given parameter at the specified time point||units on a scale||Standard Deviation|Mean
830042|NCT01235546|Other Pre-specified|Infant Pyloric Stenosis|Any diagnosis of pyloric stenosis based on clinical presentation and radiological and/or surgical confirmation|up to 3 months after birth|||Participants|||Count of Participants
830043|NCT01235546|Other Pre-specified|Neonatal Serious Adverse Events|Composite for all neonatal serious adverse events|Up to 3 months after birth|||Participants|||Count of Participants
830044|NCT01235546|Other Pre-specified|Maternal Serious Adverse Events|All maternal serious adverse events|Up to 6 weeks after delivery|||Participants|||Count of Participants
830045|NCT01235546|Other Pre-specified|Maternal Postpartum Antibiotic Use|Maternal postpartum use of antibiotics|Up to 6 weeks after delivery|||Participants|||Count of Participants
830046|NCT01235546|Other Pre-specified|Maternal Postpartum Readmission or Unscheduled Visit|Maternal postpartum unscheduled visit or readmission to the hospital|Up to 6 weeks after delivery|||Participants|||Count of Participants
830047|NCT01235546|Other Pre-specified|Maternal Fever||Up to 6 weeks after delivery|Postpartum Fever||Participants|||Count of Participants
830048|NCT01235546|Other Pre-specified|Neonatal Readmission||Up to 3 months after birth|Hospitalization after discharge||Participants|||Count of Participants
830049|NCT01235546|Other Pre-specified|Neonatal Intensive Care Unit (NICU) Admission|Neonates who are admitted to the NICU due to morbidities diagnosed from birth and up to three months of life. Morbidities as defined in the Neonatal morbidities outcome measure.|Up to 3 months after birth|||Participants|||Count of Participants
830050|NCT01235546|Other Pre-specified|Neonatal Morbidities (Listed Below)|morbidities include: death, Respiratory Distress Syndrome (RDS), Bronchopulmonary Dysplasia (BPD), Periventricular Leukomalacia (PVL) suspected or proven sepsis, Necrotizing Enterocolitis (NEC) Intraventricular Hemorrhage (IVH) and systemic inflammatory response syndrome|Up to 3 months after birth|||Participants|||Count of Participants
830051|NCT01235546|Primary|Participants With Endometritis and/or Wound Infection and/or Other Post-cesarean Infections (Occurring Within 6 Weeks of Delivery)|Endometritis was defined as the presence of at least two of the following signs with no other recognized cause: fever (temperature of at least 38°C [100.4°F]), abdominal pain, uterine tenderness, or purulent drainage from the uterus. Wound infection was defined as the presence of either superficial or deep incisional surgical-site infection characterized by cellulitis or erythema and induration around the incision or purulent discharge from the incision site with or without fever and included necrotizing fasciitis. Wound hematoma, seroma, or breakdown alone in the absence of the preceding signs did not constitute infection.|Up to 6 weeks after delivery|The specific characteristics related to the cesarean delivery, including indications for cesarean delivery, receipt of standard prophylaxis, timing of receipt of study medication, and type of surgical skin preparation, were similar in the two groups.||Participants|||Count of Participants
830052|NCT01235598|Secondary|Change From Baseline for the Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Synovitis Score at Week 2 Placebo (PBO) Versus Certolizumab Pegol (CZP)|"Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS):
Synovitis is defined as an area in the synovial compartment that shows above normal postgadolinium enhancement of a thickness greater than the width of the normal synovium. T1-weighted images were acquired before and after the administration of intravenous contrast agent containing gadolinium. Intravenous contrast was required to demonstrate enhancing synovitis. Synovitis was scored 0 to 3 in 3 wrist regions (the distal radioulnar; the radiocarpal joint; the intercarpal and carpometacarpal joints) and in each of the second through fifth metacarpophalangeal (MCP) joints. A score of 0 is normal, with no enhancement or enhancement up to the thickness of normal synovium, while scores of 1 to 3 (mild, moderate, severe) refer to increments of one-third of the presumed maximum volume of enhancing tissue in the synovial compartment.
A negative value in synovitis change from Baseline score indicates an improvement."|From Baseline to Week 2|The Analysis Population refers to the Full Analysis Set (FAS) (last observation carried forward) which consists of all randomized subjects that received at least one dose of study medication, and had a valid Baseline efficacy assessment and at least one valid post-Baseline efficacy assessment.||scores on a scale||Standard Deviation|Mean
830836|NCT01240330|Secondary|Subject Comfort|Subject comfort was measured on a scale 1 to 5 (1=negative response; 5=positive response) during the sleeve installation, during use, and completion.|10 min therapy|||Units on a Scale||Standard Deviation|Mean
830053|NCT01235598|Secondary|Change From Baseline for the Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Synovitis Score at Week 1 Placebo (PBO) Versus Certolizumab Pegol (CZP)|"Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS):
Synovitis is defined as an area in the synovial compartment that shows above normal postgadolinium enhancement of a thickness greater than the width of the normal synovium. T1-weighted images were acquired before and after the administration of intravenous contrast agent containing gadolinium. Intravenous contrast was required to demonstrate enhancing synovitis. Synovitis was scored 0 to 3 in 3 wrist regions (the distal radioulnar; the radiocarpal joint; the intercarpal and carpometacarpal joints) and in each of the second through fifth metacarpophalangeal (MCP) joints. A score of 0 is normal, with no enhancement or enhancement up to the thickness of normal synovium, while scores of 1 to 3 (mild, moderate, severe) refer to increments of one-third of the presumed maximum volume of enhancing tissue in the synovial compartment.
A negative value in synovitis change from Baseline score indicates an improvement."|From Baseline to Week 1|The Analysis Population refers to the Full Analysis Set (FAS) (last observation carried forward) which consists of all randomized subjects that received at least one dose of study medication, and had a valid Baseline efficacy assessment and at least one valid post-Baseline efficacy assessment.||scores on a scale||Standard Deviation|Mean
830054|NCT01235598|Secondary|Correlation of Change in Synovitis From Baseline as Measured by Magnetic Resonance Image (MRI) With Changes in Hand Bone Mineral Density as Measured by Digital XRay (DXR) at Week 16|"Radiographic assessment of bone mineral density in one hand and wrist were conducted by Digital X Ray (DXR) using a standardized imaging methodology. The hand and wrist to be assessed by DXR were the same as for the Magnetic Resonance Images (MRIs). The same hand and wrist were used for all x rays. The evaluation of all DXRs was performed centrally.
A negative correlation coefficient indicates that reductions in synovitis from Baseline to Week 16 are associated with increases in bone mineral density at Week 16."|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (observed case) which consists of all randomized subjects that received at least one dose of study medication. Correlations between the change from Baseline in total synovitis score at Week 16 and the clinical efficacy variables are restricted to the Certolizumab Pegol (CZP) arm only.||Spearman rank correlation coefficient|||Number
830055|NCT01235598|Secondary|Correlation of Change in Synovitis From Baseline as Measured by Magnetic Resonance Image (MRI) With Disease Activity Score-28 (DAS28 (CRP)) Response at Week 16|"The DAS28(CRP) was calculated using the tender joint count (TJC) and swollen joint count (SJC), C-Reactive Protein (CRP in mg/L) and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm).
A positive correlation coefficient indicates that reductions in synovitis from Baseline to Week 16 are associated with reductions in DAS28(CRP) at Week 16."|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (observed case) which consists of all randomized subjects that received at least one dose of study medication. Correlations between the change from Baseline in total synovitis score at Week 16 and the clinical efficacy variables are restricted to the Certolizumab Pegol (CZP) arm only.||Spearman rank correlation coefficient|||Number
830056|NCT01235598|Secondary|Correlation of Change in Synovitis From Baseline as Measured by Magnetic Resonance Image (MRI) With American College of Rheumatology 70 % Criteria (ACR70) at Week 16|"Subjects who meet the ACR70 criteria are those subjects with at least 70 % improvement from Baseline for Tender Joint Count (TJC), Swollen Joint Count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-Reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS).
A negative correlation coefficient indicates that reductions in synovitis from Baseline to Week 16 are associated with an ACR70 response at Week 16."|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (observed case) which consists of all randomized subjects that received at least one dose of study medication. Correlations between the change from Baseline in total synovitis score at Week 16 and the clinical efficacy variables are restricted to the Certolizumab Pegol (CZP) arm only.||Spearman rank correlation coefficient|||Number
830057|NCT01235598|Secondary|Correlation of Change in Synovitis From Baseline as Measured by Magnetic Resonance Image (MRI) With American College of Rheumatology 50 % Criteria (ACR50) at Week 16|"Subjects who meet the ACR50 criteria are those subjects with at least 50 % improvement from Baseline for Tender Joint Count (TJC), Swollen Joint Count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-Reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS).
A negative correlation coefficient indicates that reductions in synovitis from Baseline to Week 16 are associated with an ACR50 response at Week 16."|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (observed case) which consists of all randomized subjects that received at least one dose of study medication. Correlations between the change from Baseline in total synovitis score at Week 16 and the clinical efficacy variables are restricted to the Certolizumab Pegol (CZP) arm only.||Spearman rank correlation coefficient|||Number
830058|NCT01235598|Secondary|Correlation of Change in Synovitis From Baseline as Measured by Magnetic Resonance Image (MRI) With American College of Rheumatology 20 % Criteria (ACR20) at Week 16|"Subjects who meet the ACR20 criteria are those subjects with at least 20 % improvement from Baseline for Tender Joint Count (TJC), Swollen Joint Count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-Reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS).
A negative correlation coefficient indicates that reductions in synovitis from Baseline to Week 16 are associated with an ACR20 response at Week 16."|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (observed case) which consists of all randomized subjects that received at least one dose of study medication. Correlations between the change from Baseline in total synovitis score at Week 16 and the clinical efficacy variables are restricted to the Certolizumab Pegol (CZP) arm only.||Spearman rank correlation coefficient|||Number
830059|NCT01235598|Secondary|Correlation of Change in Synovitis From Baseline as Measured by Magnetic Resonance Image (MRI) With European League Against Rheumatism (EULAR) Response at Week 16|"EULAR (European League Against Rheumatism) response: EULAR response is based upon current Disease Activity Score 28 (DAS28) level and corresponding change from Baseline in DAS28.
Good EULAR response is defined as: DAS28 C-Reactive Protein (CRP) ≤ 3.2 and decrease from Baseline by > 1.2; moderate response is defined as achievement of one of the following:
DAS28(CRP) ≤ 3.2 and decrease from Baseline > 0.6 and ≤ 1.2
DAS28(CRP) > 3.2 and ≤ 5.1 and decrease from Baseline > 0.6
DAS28(CRP) > 5.1 and decrease from Baseline > 1.2
A negative correlation coefficient indicates that reductions in synovitis from Baseline to Week 16 are associated with better EULAR responses."|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (observed case) which consists of all randomized subjects that received at least one dose of study medication. Correlations between the change from Baseline in total synovitis score at Week 16 and the clinical efficacy variables are restricted to the Certolizumab Pegol (CZP) arm only.||Spearman rank correlation coefficient|||Number
830060|NCT01235598|Secondary|C-Reactive Protein (CRP) Ratio to Baseline at Week 16|"The C-Reactive Protein (CRP) is considered a marker of inflammation in subjects with Rheumatoid Arthritis.
A ratio to Baseline < 1 indicates an improvement."|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (observed case) which consists of all randomized subjects that received at least one dose of study medication, and had a valid Baseline efficacy assessment and at least one valid post-Baseline efficacy assessment.||ratio||Geometric Coefficient of Variation|Geometric Mean
830061|NCT01235598|Secondary|Change From Baseline to Week 16 in Health Assessment Questionnaire - Disability Index (HAQ-DI)|The Health Assessment Questionnaire-Disability Index (HAQ-DI) is a subject reported questionnaire that provides an assessment of the impact of the disease and its treatment on physical function. The HAQ-DI assesses the degree of difficulty experienced in 8 domains of daily living activities using 20 questions. The domains are dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities, and each domain (activity) consists of 2 or 3 items. For each question the level of difficulty is scored from 0 to 3 where 0 = no difficulty, 1 = some difficulty, 2 = much difficulty and 3 = unable to do. A total score is computed from the item scores using the scoring rules provided by the author (Fries, 1980). The total score ranges from 0 to 3 with lower scores meaning lower disability. A negative value in HAQ-DI change from Baseline indicates an improvement.|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (observed case) which consists of all randomized subjects that received at least one dose of study medication.||scores on a scale||Standard Deviation|Mean
830062|NCT01235598|Secondary|Change From Baseline to Week 16 in Swollen Joint Count (SJC)|"The joint assessment was carried out on 28 joints. Swelling and tenderness were graded on a 2-point scale (answered with Yes/No). No indicated None swelling response and Yes indicated that there was a detectable synovial thickening with or without loss of bony contours, or bulging synovial proliferation with or without cystic characteristics. If there were missing observations in the SJC, then the remaining observations were assessed and weighted by dividing by the number of non-missing joint counts and multiplying by 28. SJC ranges from 0 to 28 with 0 indicating no swollen joints and 28 indicating swelling in all joints. A negative value in SJC change from Baseline indicates an improvement."|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (observed case) which consists of all randomized subjects that received at least one dose of study medication.||units on a scale||Standard Deviation|Mean
830063|NCT01235598|Secondary|Change From Baseline to Week 16 in Tender Joint Count (TJC)|"The joint assessment was carried out on 28 joints. Swelling and tenderness were graded on a 2-point scale (answered with Yes/No). No indicated Not tender; Yes indicated a positive tenderness response that was defined as a positive response to questioning (tender), spontaneous response elicited (tender and winced) or withdrawal by subject on examination (tender, winced, and withdrew). If there were missing observations in the TJC, then the remaining observations were assessed and weighted by dividing by the number of non-missing joint counts and multiplying by 28. TJC ranges from 0 to 28 with 0 indicating no tender joints and 28 indicating tenderness in all joints. A negative value in TJC change from Baseline indicates an improvement."|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (observed case) which consists of all randomized subjects that received at least one dose of study medication.||units on a scale||Standard Deviation|Mean
830064|NCT01235598|Secondary|Change From Baseline to Week 16 in Bone Mineral Density as Measured by Digital XRay (DXR)|"Radiographic assessment of bone mineral density in one hand and wrist were conducted by Digital X Ray (DXR) using a standardized imaging methodology. The hand and wrist to be assessed by DXR were the same as for the Magnetic Resonance Images (MRIs). The same hand and wrist were used for all x rays. The evaluation of all DXRs was performed centrally.
A positive value in Bone Mineral Density change from Baseline indicates an improvement."|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (observed case) which consists of all randomized subjects that received at least one dose of study medication.||g/cm^2||Standard Deviation|Mean
830065|NCT01235598|Secondary|Percentage of Subjects Achieving Disease Activity Score 28 (DAS28 (CRP)) Remission Status (DAS28 (CRP) < 2.6) at Week 16|DAS28[CRP] is a composite index and is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) C-reactive protein (CRP in mg/l), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.36 x lognat (CRP+1) + 0.014 x Global Assessment of Arthritis + 0.96 where 28 joints are examined and a lower score indicates less disease activity. A DAS(28) score of higher than 5.1 is indicative of high disease activity whereas a DAS score below 3.2 indicates low disease activity. A patient is considered to be in remission if they have a DAS28 lower than 2.6.|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (observed case) which consists of all randomized subjects that received at least one dose of study medication, and had a valid Baseline efficacy assessment and at least one valid post-Baseline efficacy assessment.||percentage of subjects|||Number
830145|NCT01227629|Secondary|Thromboembolic Events: Number of Participants With Other Major Cardiac Events|Occurence of other major adverse cardiac events|12 weeks|All randomized patients. No statistical comparisons were performed, due to the extremely small number of events.||Participants|||Number
830146|NCT01227629|Secondary|Thromboembolic Events: Number of Participants With Myocardial Infarction|Occurence of a myocardial infarction|12 weeks|All randomized patients. No statistical comparisons were performed, due to the extremely small number of events.||Participants|||Number
830066|NCT01235598|Secondary|Change From Baseline to Week 16 in the Disease Activity Score-28 (C-Reactive Protein) (DAS28 (CRP)) Response|DAS28[CRP] is a composite index and is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) C-reactive protein (CRP in mg/l), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.36 x lognat (CRP+1) + 0.014 x Global Assessment of Arthritis + 0.96 where 28 joints are examined and a lower score indicates less disease activity. A DAS(28) score of higher than 5.1 is indicative of high disease activity whereas a DAS score below 3.2 indicates low disease activity. A patient is considered to be in remission if they have a DAS28 lower than 2.6. A negative value in DAS28[CRP] change from Baseline indicates an improvement from Baseline.|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (observed case) which consists of all randomized subjects that received at least one dose of study medication.||units on a scale||Standard Deviation|Mean
830067|NCT01235598|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 70 % Criteria (ACR70) at Week 16|Subjects who meet the ACR70 criteria are those subjects with at least 70 % improvement from Baseline for Tender Joint Count (TJC), Swollen Joint Count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-Reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS).|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (observed case) which consists of all randomized subjects that received at least one dose of study medication.||percentage of subjects|||Number
830068|NCT01235598|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 50 % Criteria (ACR50) at Week 16|Subjects who meet the ACR50 criteria are those subjects with at least 50 % improvement from Baseline for Tender Joint Count (TJC), Swollen Joint Count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-Reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS).|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (observed case) which consists of all randomized subjects that received at least one dose of study medication.||percentage of subjects|||Number
830069|NCT01235598|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20 % Criteria (ACR20) at Week 16|Subjects who meet the ACR20 criteria are those subjects with at least 20 % improvement from Baseline for Tender Joint Count (TJC), Swollen Joint Count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-Reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS).|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (observed case) which consists of all randomized subjects that received at least one dose of study medication.||percentage of subjects|||Number
830070|NCT01235598|Secondary|Percentage of Subjects Achieving a Good European League Against Rheumatism (EULAR) Response at Week 16|"EULAR (European League Against Rheumatism) response: EULAR response is based upon current Disease Activity Score 28 (DAS28) level and corresponding change from Baseline in DAS28.
Good EULAR response is defined as: DAS28 C-Reactive Protein (CRP) ≤ 3.2 and decrease from Baseline by > 1.2; moderate response is defined as achievement of one of the following:
DAS28(CRP) ≤ 3.2 and decrease from Baseline > 0.6 and ≤ 1.2
DAS28(CRP) > 3.2 and ≤ 5.1 and decrease from Baseline > 0.6
DAS28(CRP) > 5.1 and decrease from Baseline > 1.2"|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (observed case) which consists of all randomized subjects that received at least one dose of study medication.||percentage of subjects|||Number
830071|NCT01235598|Secondary|Change From Baseline to Week 16 in the Dynamic Magnetic Resonance Image (MRI) Parameter, Number of Voxels (Nvox) With Plateau and Washout Pattern|"Contrast enhancement can be quantified in terms of the dynamic MRI parameters initial rate of enhancement (IRE), maximum enhancement (ME), and number of voxels (Nvox) with Plateau and Washout pattern. These parameters are extracted by examining individual signal intensity versus time curves derived from defined regions of interest.
Nvox indicates the number of voxels showing enhancement patterns. It is representative of the size or volume of enhancement and representative of underlying inflammation. The higher the value, the higher the volume .
ME and IRE values quantify the intensity of signal within the enhancing voxels. The absolute values and changes from Baseline in the MRI parameters of IRE, ME, and Nvox of the selected hand and wrist were estimated at Weeks 1, 2, 4, 8, and 16.
The values presented are for Proximal Interphalangeal (PIP) and Metacarpophalangeal (MCP) joints combined. A negative value in Nvox change from Baseline score indicates an improvement."|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (last observation carried forward) which consists of all randomized subjects that received at least one dose of study medication. As pre-specified in the protocol, this analysis is restricted to the Certolizumab Pegol (CZP) arm.||voxels||Standard Deviation|Mean
830072|NCT01235598|Secondary|Change From Baseline to Week 16 in the Dynamic Magnetic Resonance Image (MRI) Parameter, Maximal Enhancement (ME)|"Contrast enhancement can be quantified in terms of the dynamic MRI parameters initial rate of enhancement (IRE), maximum enhancement (ME), and number of voxels (Nvox) with Plateau and Washout pattern. These parameters are extracted by examining individual signal intensity versus time curves derived from defined regions of interest.
Nvox indicates the number of voxels showing enhancement patterns. It is representative of the size or volume of enhancement and representative of underlying inflammation. The higher the value, the higher the volume .
ME and IRE values quantify the intensity of signal within the enhancing voxels. The absolute values and changes from Baseline in the MRI parameters of IRE, ME, and Nvox of the selected hand and wrist were estimated at Weeks 1, 2, 4, 8, and 16.
The values presented are for Proximal Interphalangeal (PIP) and Metacarpophalangeal (MCP) joints combined. A negative value in ME change from Baseline score indicates an improvement."|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (last observation carried forward) which consists of all randomized subjects that received at least one dose of study medication. As pre-specified in the protocol, this analysis is restricted to the Certolizumab Pegol (CZP) arm.||percent change over pre-contrast||Standard Deviation|Mean
830073|NCT01235598|Secondary|Change From Baseline to Week 16 in the Dynamic Magnetic Resonance Image (MRI) Parameter, Initiation Rate of Enhancement (IRE)|"Contrast enhancement can be quantified in terms of the dynamic MRI parameters initial rate of enhancement (IRE), maximum enhancement (ME), and number of voxels (Nvox) with Plateau and Washout pattern. These parameters are extracted by examining individual signal intensity versus time curves derived from defined regions of interest.
Nvox indicates the number of voxels showing enhancement patterns. It is representative of the size or volume of enhancement and representative of underlying inflammation. The higher the value, the higher the volume .
ME and IRE values quantify the intensity of signal within the enhancing voxels. The absolute values and changes from Baseline in the MRI parameters of IRE, ME, and Nvox of the selected hand and wrist were estimated at Weeks 1, 2, 4, 8, and 16.
The values presented are for Proximal Interphalangeal (PIP) and Metacarpophalangeal (MCP) joints combined. A negative value in IRE change from Baseline score indicates an improvement."|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (last observation carried forward) which consists of all randomized subjects that received at least one dose of study medication. As pre-specified in the protocol, this analysis is restricted to the Certolizumab Pegol (CZP) arm.||percent per second||Standard Deviation|Mean
830074|NCT01235598|Primary|Change in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score at Week 1 Compared to Baseline for Certolizumab Pegol Arm|"Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS):
Synovitis is defined as an area in the synovial compartment that shows above normal postgadolinium enhancement of a thickness greater than the width of the normal synovium. T1-weighted images were acquired before and after the administration of intravenous contrast agent containing gadolinium. Intravenous contrast was required to demonstrate enhancing synovitis. Synovitis was scored 0 to 3 in 3 wrist regions and in each of the second through fifth metacarpophalangeal (MCP) joints. A score of 0 is normal, with no enhancement or enhancement up to the thickness of normal synovium, while scores of 1 to 3 (mild, moderate, severe) refer to increments of one-third of the presumed maximum volume of enhancing tissue in the synovial compartment. Total synovitis score ranges from a minimum of 0 to a maximum of 21. A negative value in synovitis change from Baseline score indicates an improvement."|From Baseline to Week 1|The Analysis Population refers to the Full Analysis Set (FAS) (last observation carried forward) which consists of all randomized subjects that received at least one dose of study medication. As pre-specified in the protocol, this analysis is restricted to the Certolizumab Pegol (CZP) arm.||scores on a scale||Standard Deviation|Mean
830075|NCT01235598|Primary|Change in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score at Week 2 Compared to Baseline for Certolizumab Pegol Arm|"Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS):
Synovitis is defined as an area in the synovial compartment that shows above normal postgadolinium enhancement of a thickness greater than the width of the normal synovium. T1-weighted images were acquired before and after the administration of intravenous contrast agent containing gadolinium. Intravenous contrast was required to demonstrate enhancing synovitis. Synovitis was scored 0 to 3 in 3 wrist regions and in each of the second through fifth metacarpophalangeal (MCP) joints. A score of 0 is normal, with no enhancement or enhancement up to the thickness of normal synovium, while scores of 1 to 3 (mild, moderate, severe) refer to increments of one-third of the presumed maximum volume of enhancing tissue in the synovial compartment. Total synovitis score ranges from a minimum of 0 to a maximum of 21. A negative value in synovitis change from Baseline score indicates an improvement."|From Baseline to Week 2|The Analysis Population refers to the Full Analysis Set (FAS) (last observation carried forward) which consists of all randomized subjects that received at least one dose of study medication. As pre-specified in the protocol, this analysis is restricted to the Certolizumab Pegol (CZP) arm.||scores on a scale||Standard Deviation|Mean
830076|NCT01235598|Primary|Change in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score at Week 4 Compared to Baseline for Certolizumab Pegol Arm|"Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS):
Synovitis is defined as an area in the synovial compartment that shows above normal postgadolinium enhancement of a thickness greater than the width of the normal synovium. T1-weighted images were acquired before and after the administration of intravenous contrast agent containing gadolinium. Intravenous contrast was required to demonstrate enhancing synovitis. Synovitis was scored 0 to 3 in 3 wrist regions and in each of the second through fifth metacarpophalangeal (MCP) joints. A score of 0 is normal, with no enhancement or enhancement up to the thickness of normal synovium, while scores of 1 to 3 (mild, moderate, severe) refer to increments of one-third of the presumed maximum volume of enhancing tissue in the synovial compartment. Total synovitis score ranges from a minimum of 0 to a maximum of 21. A negative value in synovitis change from Baseline score indicates an improvement."|From Baseline to Week 4|The Analysis Population refers to the Full Analysis Set (FAS) (last observation carried forward) which consists of all randomized subjects that received at least one dose of study medication. As pre-specified in the protocol, this analysis is restricted to the Certolizumab Pegol (CZP) arm.||scores on a scale||Standard Deviation|Mean
830077|NCT01235598|Primary|Change in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score at Week 8 Compared to Baseline for Certolizumab Pegol Arm|"Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS):
Synovitis is defined as an area in the synovial compartment that shows above normal postgadolinium enhancement of a thickness greater than the width of the normal synovium. T1-weighted images were acquired before and after the administration of intravenous contrast agent containing gadolinium. Intravenous contrast was required to demonstrate enhancing synovitis. Synovitis was scored 0 to 3 in 3 wrist regions and in each of the second through fifth metacarpophalangeal (MCP) joints. A score of 0 is normal, with no enhancement or enhancement up to the thickness of normal synovium, while scores of 1 to 3 (mild, moderate, severe) refer to increments of one-third of the presumed maximum volume of enhancing tissue in the synovial compartment. Total synovitis score ranges from a minimum of 0 to a maximum of 21. A negative value in synovitis change from Baseline score indicates an improvement."|From Baseline to Week 8|The Analysis Population refers to the Full Analysis Set (FAS) (last observation carried forward) which consists of all randomized subjects that received at least one dose of study medication. As pre-specified in the protocol, this analysis is restricted to the Certolizumab Pegol (CZP) arm.||scores on a scale||Standard Deviation|Mean
830078|NCT01235598|Primary|Change in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score at Week 16 Compared to Baseline for Certolizumab Pegol Arm|"Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS):
Synovitis is defined as an area in the synovial compartment that shows above normal postgadolinium enhancement of a thickness greater than the width of the normal synovium. T1-weighted images were acquired before and after the administration of intravenous contrast agent containing gadolinium. Intravenous contrast was required to demonstrate enhancing synovitis. Synovitis was scored 0 to 3 in 3 wrist regions and in each of the second through fifth metacarpophalangeal (MCP) joints. A score of 0 is normal, with no enhancement or enhancement up to the thickness of normal synovium, while scores of 1 to 3 (mild, moderate, severe) refer to increments of one-third of the presumed maximum volume of enhancing tissue in the synovial compartment. Total synovitis score ranges from a minimum of 0 to a maximum of 21. A negative value in synovitis change from Baseline score indicates an improvement."|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (last observation carried forward) which consists of all randomized subjects that received at least one dose of study medication. As pre-specified in the protocol, this analysis is restricted to the Certolizumab Pegol (CZP) arm.||scores on a scale||Standard Deviation|Mean
830079|NCT01227512|Secondary|Percentage of Participants Requiring Rescue Therapy for Hyponatremia|Percentage of participants requiring rescue therapy within first 7 days of treatment for hyponatremia.|7 days|Analysis was performed on the modified intent-to-treat population (MITT) which included all randomized participants who received at least one dose of study drug regardless of any protocol violation. Data were missing for 3 participants in the placebo group.||Percentage of participants|||Number
830080|NCT01227512|Secondary|Percentage of Participants With Clinical Global Impression-Improvement (CGI-I) Score Improved to a Score of 1 or 2.|Percentage of responders (defined as CGI-I score of 1 = very much improved or 2 = much improved) at 48 hours post-first dose, or at discharge/rescue therapy, if earlier. Participants given rescue therapy were given a score of 7.|48 hours post dose|Analysis was performed on the modified intent-to-treat population (MITT) which included all randomized participants who received at least one dose of study drug regardless of any protocol violation. Data were missing for 2 participants in the tolvaptan group and 3 participants in the placebo group.||Percentage of participants|||Number
830081|NCT01227512|Secondary|Time to First 2-point Improvement in CGI-S Score.|CGI-S data up to 72 hours were used to identify 2-point improvements. Please refer to outcome measure 2 for details on the scale. For the analysis of time to first 2-point improvement in CGI-S, CGI-S data up to Hour 72 were used to identify 2-point improvements. Data for participants who received rescue therapy were censored at the time of receiving rescue therapy. For participants who were discharged before Hour 72 without reaching 2-point improvement in CGI-S, data were censored at the time of discharge. Other participants who did not reach the 2-point improvement during the 72 hours also had their data censored at their last CGI-S observations within 72 hours.|Up to 72 hours|Analysis was performed on the modified intent-to-treat population (MITT) which included all randomized participants who received at least one dose of study drug regardless of any protocol violation. Data were missing for 1 participant in the tolvaptan group and 3 participants in the placebo group.||Hours||95% Confidence Interval|Median
830082|NCT01227512|Secondary|Change From Baseline in Serum Sodium Concentration (24 Hour Area Under the Curve [AUC]).|"Average 24 hour AUC of serum sodium concentration change from baseline, from Day 1 Hour 0 up to 72 hours post-first dose was assessed.
A serum sodium sample was drawn at pre-treament and 8, 24, 48, and 72 hours post-first dose. Serum sodium was also assessed between 36 and 72 hours after the last dose.
Analysis of AUC was for daily average AUC, hence the units or AUC are mEq/L/24 hours."|0 to 72 hours|"Analysis was performed on the modified intent-to-treat population (MITT) which included all randomized participants who received at least one dose of study drug regardless of any protocol violation.
Data were missing for 3 participants in the tolvaptan group and 1 participant in the placebo group."||mEq/L||Full Range|Least Squares Mean
830083|NCT01227512|Secondary|Change From Baseline to 48 Hours Post Dose in Clinical Global Impression - Improvement (CGI-I) Score of Hyponatremia Symptoms.|"Change in CGI-I score at 48 hours post-first dose or discharge/rescue therapy, if earlier was assessed.
The CGI-I is a one-question rating scale where the participant is asked to rate total improvement whether or not, in their judgment, it is due entirely to trial treatment. Compared to his/her condition at admission to the trial, how much has he/she changed? 0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse"|Baseline to 48 hours post dose|Analysis was performed on the modified intent-to-treat population (MITT) which included all randomized participants who received at least one dose of study drug regardless of any protocol violation. Data were not available for 2 participants in the tolvaptan group.||Units on a scale||Full Range|Median
830084|NCT01227512|Secondary|Change From Baseline to 24 and 72 Hours Post Dose in CGI-S of Hyponatremia Symptoms.|"Change in CGI-S of hyponatremia symptoms from pretreatment baseline at 24 and 72 hours post-first dose, or at discharge/rescue therapy if earlier was assessed.
The CGI-S is a one-question rating scale which was as follows: “Considering your total clinical experience with hyponatremia symptoms in this particular population, how symptomatic is the patient at this time?” 0=not assessed; 1=normal, not at all symtpmatic; 2=borderline symptomatic; 3=mildly symptomatic; 4=moderately symptomatic; 5=markedly symptomatic; 6=severely symptomatic; 7=among the most severly symptomatic patients."|Baseline to 24 and 72 hours post dose|"Analysis was performed on the modified intent-to-treat population (MITT) which included all randomized participants who received at least one dose of study drug regardless of any protocol violation.
Data were missing for one participant in the Tolvaptan group."||Units on a scale||Full Range|Median
830095|NCT01227564|Other Pre-specified|Change From Baseline in PDQ – Subject – Total Score|The PDQ is a tool consisting of 20 questions and is designed to assess perceived cognitive deficits from the participant’s perspective. The instrument assessed a variety of questions in the following areas: attention/concentration, retrospective memory, prospective memory, and planning/organization. The Total Score is computed by adding raw scores for all of the items (or all 4 domain scores) together. It could range from 0 – 80, with higher scores indicating greater perceived cognitive impairment.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.||score||Standard Deviation|Mean
839375|NCT01318122|Secondary|Change From Baseline in Fasting Blood Glucose (Week 8).|The change between the value of fasting blood glucose collected at week 8 and baseline.|Baseline and Week 8.|Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
830085|NCT01227512|Secondary|Change From Baseline to 48 Hour Post Dose in Clinical Global Impression-Severity (CGI-S) of Hyponatremia Symptoms.|"Change from baseline in blinded rater assessed CGI-S at 48 hours post-first dose or at discharge/rescue therapy, if earlier was assessed.
The CGI-S is a one-question rating scale which was as follows: “Considering your total clinical experience with hyponatremia symptoms in this particular population, how symptomatic is the patient at this time?” 0=not assessed; 1=normal, not at all symtpmatic; 2=borderline symptomatic; 3=mildly symptomatic; 4=moderately symptomatic; 5=markedly symptomatic; 6=severely symptomatic; 7=among the most severly symptomatic patients."|Baseline to 48 hours post dose|"Analysis was performed on the modified intent-to-treat population (MITT) which included all randomized participants who received at least one dose of study drug regardless of any protocol violation.
Data were missing for one participant in the Tolvaptan group."||Units on a scale||Full Range|Median
830086|NCT01227512|Primary|Length of Hospital Stay (LoS)|LoS was time to clinically ready to be hospital discharged (CRBD) from study treatment initiation, disregarding prolonged hospitalization due solely to social factors.|45 days|Analysis was performed on the modified intent-to-treat population (MITT) which included all randomized participants who received at least one dose of study drug regardless of any protocol violation.||Days||95% Confidence Interval|Median
830087|NCT01227551|Secondary|Durable Response Rate|Per Immune-Related Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT/MRI or calipers: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Durable Response Rate (DRR) = CR + PR.|6 months or more|ITT Population||percentage of participants|||Number
830088|NCT01227551|Primary|Percentage of Participants With Immune-related Progression-Free Survival (irPFS) at 6 Months|To assess the clinical efficacy of Intratumoral (IT) CVA21 in terms of immune-related Progression-Free Survival (irPFS) at 6 months.|6 months|ITT Population||percentage of participants||95% Confidence Interval|Number
830089|NCT01227564|Other Pre-specified|Alzheimer’s Disease Medication Administration Concerns Questionnaire (AD MACQ)|The AD MACQ was administered to the study partner to address preferences for medication administration by assessing: Question a: I would find it easy to give the study medication to the patient myself. Question b: The number of times the medication was given was convenient. Question c: I would prefer to have the study medication given at home by me instead of at the doctor's office by the doctor or nurse. Question d: I would prefer to have the study medication given at home by a nurse instead of at the doctor's office by the doctor or nurse. Question e: Overall, I am satisfied with the way the medication was given.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.||percentage of participants|||Number
830090|NCT01227564|Other Pre-specified|Change From Baseline in PDQ-R – Relative – Total Score|The PDQ-R is a tool consisting of 20 questions, is designed to assess perceived cognitive deficits, and was administered to the study partner. The instrument assessed a variety of questions in the following areas: attention/concentration, retrospective memory, prospective memory, and planning/organization. The Total Score is computed by adding raw scores for all of the items (or all 4 domain scores) together. It could range from 0 – 80, with higher scores indicating greater perceived cognitive impairment.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.||score||Standard Deviation|Mean
830091|NCT01227564|Other Pre-specified|Change From Baseline in PDQ-R – Relative – Planning/Organization Domain Score|The PDQ-R is a tool consisting of 20 questions, is designed to assess perceived cognitive deficits, and was administered to the study partner. The instrument assessed a variety of questions in the following areas: attention/concentration, retrospective memory, prospective memory, and planning/organization. The Planning/Organization Domain Score is the sum of the raw scores on items 4, 8, 12, 16, and 20, with a range from 0 – 4 for each of the 5 items. So the Planning/Organization Domain Score could range from 0 – 20, with higher scores indicating greater perceived cognitive impairment.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.||score||Standard Deviation|Mean
830092|NCT01227564|Other Pre-specified|Change From Baseline in PDQ-R – Relative – Prospective Memory Domain Score|The PDQ-R is a tool consisting of 20 questions, is designed to assess perceived cognitive deficits, and was administered to the study partner. The instrument assessed a variety of questions in the following areas: attention/concentration, retrospective memory, prospective memory, and planning/organization. The Prospective Memory Domain Score is the sum of the raw scores on items 3, 7, 11, 15, and 19, with a range from 0 – 4 for each of the 5 items. So the Prospective Memory Domain Score could range from 0 – 20, with higher scores indicating greater perceived cognitive impairment.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.||score||Standard Deviation|Mean
830093|NCT01227564|Other Pre-specified|Change From Baseline in PDQ-R – Relative – Retrospective Memory Domain Score|The PDQ-R is a tool consisting of 20 questions, is designed to assess perceived cognitive deficits, and was administered to the study partner. The instrument assessed a variety of questions in the following areas: attention/concentration, retrospective memory, prospective memory, and planning/organization. The Retrospective Memory Domain Score is the sum of the raw scores on items 2, 6, 10, 14, and 18, with a range from 0 – 4 for each of the 5 items. So the Retrospective Memory Domain Score could range from 0 – 20, with higher scores indicating greater perceived cognitive impairment.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.||score||Standard Deviation|Mean
830094|NCT01227564|Other Pre-specified|Change From Baseline in PDQ-R – Relative – Attention/Concentration Domain Score|The PDQ-R is a tool consisting of 20 questions, is designed to assess perceived cognitive deficits, and was administered to the study partner. The instrument assessed a variety of questions in the following areas: attention/concentration, retrospective memory, prospective memory, and planning/organization. The Attention/Concentration Domain Score is the sum of the raw scores on items 1, 5, 9, 13, and 17, with a range from 0 – 4 for each of the 5 items. So the Attention/Concentration Domain Score could range from 0 – 20, with higher scores indicating greater perceived cognitive impairment.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.||score||Standard Deviation|Mean
830147|NCT01227629|Secondary|Thromboembolic Events: Number of Participants With Systemic Thromboembolism|Occurence of a systemic thromboembolism|12 weeks|All randomized patients. No statistical comparisons were performed, due to the extremely small number of events.||Participants|||Number
830096|NCT01227564|Other Pre-specified|Change From Baseline in PDQ – Subject – Planning/Organization Domain Score|The PDQ is a tool consisting of 20 questions and is designed to assess perceived cognitive deficits from the participant’s perspective. The instrument assessed a variety of questions in the following areas: attention/concentration, retrospective memory, prospective memory, and planning/organization. The Planning/Organization Domain Score is the sum of the raw scores on items 4, 8, 12, 16, and 20, with a range from 0 – 4 for each of the 5 items. So the Planning/Organization Domain Score could range from 0 – 20, with higher scores indicating greater perceived cognitive impairment.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.||score||Standard Deviation|Mean
830097|NCT01227564|Other Pre-specified|Change From Baseline in PDQ – Subject – Prospective Memory Domain Score|The PDQ is a tool consisting of 20 questions and is designed to assess perceived cognitive deficits from the participant’s perspective. The instrument assessed a variety of questions in the following areas: attention/concentration, retrospective memory, prospective memory, and planning/organization. The Prospective Memory Domain Score is the sum of the raw scores on items 3, 7, 11, 15, and 19, with a range from 0 – 4 for each of the 5 items. So the Prospective Memory Domain Score could range from 0 – 20, with higher scores indicating greater perceived cognitive impairment.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.||score||Standard Deviation|Mean
830098|NCT01227564|Other Pre-specified|Change From Baseline in PDQ – Subject – Retrospective Memory Domain Score|The PDQ is a tool consisting of 20 questions and is designed to assess perceived cognitive deficits from the participant’s perspective. The instrument assessed a variety of questions in the following areas: attention/concentration, retrospective memory, prospective memory, and planning/organization. The Retrospective Memory Domain Score is the sum of the raw scores on items 2, 6, 10, 14, and 18, with a range from 0 – 4 for each of the 5 items. So the Retrospective Memory Domain Score could range from 0 – 20, with higher scores indicating greater perceived cognitive impairment.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.||score||Standard Deviation|Mean
830099|NCT01227564|Other Pre-specified|Change From Baseline in Perceived Deficits Questionnaire (PDQ) – Subject – Attention/Concentration Domain Score|The PDQ is a tool consisting of 20 questions and is designed to assess perceived cognitive deficits from the participant’s perspective. The instrument assessed a variety of questions in the following areas: attention/concentration, retrospective memory, prospective memory, and planning/organization. The Attention/Concentration Domain Score is the sum of the raw scores on items 1, 5, 9, 13 and 17, with a range from 0 – 4 for each of the 5 items. So the Attention/Concentration Domain Score could range from 0 – 20, with higher scores indicating greater perceived cognitive impairment.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.||score||Standard Deviation|Mean
830100|NCT01227564|Other Pre-specified|Geometric Mean Anti-Aβ IgM ELISA Titers|Site personnel collecting the samples for anti-Aβ antibody titers were blinded to the participant treatment group assignment. The LLOQ determined for this assay was 50 U/mL. For any anti-Aβ IgM antibody level that was below the LLOQ (50 U/mL), the LLOD defined as 0.5*LLOQ was imputed.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.||U/ml||95% Confidence Interval|Geometric Mean
830101|NCT01227564|Other Pre-specified|Geometric Mean Anti-Aβ IgG Enzyme-linked Immunosorbent Assay (ELISA) Titers|Site personnel collecting the samples for anti-Aβ antibody titers were blinded to the participant treatment group assignment. The lower limit of quantification (LLOQ) determined for this assay was 100 U/mL. For any anti-Aβ IgG antibody level that was below the LLOQ (100 U/mL), the lower limit of detection (LLOD) defined as 0.5*LLOQ was imputed.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.||U/ml||95% Confidence Interval|Geometric Mean
830102|NCT01227564|Other Pre-specified|Percentage of Participants With a Global CDR Score of Equal to or Greater Than 1 for the First Time|CDR is a global clinical staging instrument that was administrated by a trained rater to assess a participant’s level of impairment in six domains including: Memory, Orientation, Judgement and Problem Solving, Community Affairs, Home and Hobbies, and Personal Care, based on the CDR interview. The CDR included discussions with the participant and study partner using a structured format. CDR global score was derived from the six domains according to a complex algorithm with emphasis on the Memory Domain score. Global CDR score = 0.5 with memory box score of 0.5. The total CDR-SB score is calculated as the sum of the six clinical ratings. The CDR-SOB score range for each domain is 0 to 3, with higher score indicating no significant function. If any individual item is missing, then the CDR-SB is set to missing.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.||percentage of participants|||Number
830103|NCT01227564|Other Pre-specified|Change From Baseline in RUD (Abbreviated) (RUD-Lite) - Other Caregivers|An abbreviated administration of the RUD (RUD-Lite) was used. The RUD-Lite is a comprehensive tool for addressing the magnitude and nature of study partner/caregiver effort in cases of dementia. Since a significant portion of care in Alzheimer’s related-dementia was performed informally by the participant’s friends or family, it was desirable to measure the extent of this care for use in economic evaluations of disease. The total time spent by the other caregivers providing support on ADL, IADL and supervising, respectively, was calculated in two components. Total number of days spent during the past month on each of ADL, IADL and supervising; and: time per day during the past month on each of ADL, IADL, and supervising. The total Other Caregiver Time per month could range from 0 – 720. This was calculated by multiplying the number of days per month (30) by the number of hours per day (24).|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.||hours||95% Confidence Interval|Least Squares Mean
830111|NCT01227564|Other Pre-specified|Change From Baseline in Functional Activities Questionnaire (FAQ) Total Score|FAQ is a 10-item, caregiver-based questionnaire and was administered to the study partner who was asked to rate the participant’s ability to perform a variety of activities ranging from shopping, doing the laundry, simple financial transactions, comprehension of current events, some recreational or avocational activities, and reading. FAQ total score was calculated by adding the scores from each of the 10 items. A negative change indicated an improvement from baseline. FAQ Total Score is the sum of 10 items, ranging from 0 (best possible outcome) to 100 (worst possible outcome).|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.||score||95% Confidence Interval|Least Squares Mean
830104|NCT01227564|Other Pre-specified|Change From Baseline in Resource Utilization in Dementia (RUD) (Abbreviated) (RUD-Lite) - Primary Caregiver|An abbreviated administration of the RUD (RUD-Lite) was used. The RUD-Lite is a comprehensive tool for addressing the magnitude and nature of study partner/caregiver effort in cases of dementia. Since a significant portion of care in Alzheimer’s related-dementia was performed informally by the participant’s friends or family, it was desirable to measure the extent of this care for use in economic evaluations of disease. The total time spent by the primary caregiver providing support on activities of daily living (ADL), instrumental activities of daily living (IADL) and supervising, respectively, was calculated in two components. Total number of days spent during the past month on each of ADL, IADL, and supervising; and: time per day during the past month on each of ADL, IADL and supervising. The total Primary Caregiver Time per month could range from 0 – 720. This was calculated by multiplying the number of days per month (30) by the number of hours per day (24).|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.||hours||95% Confidence Interval|Least Squares Mean
830105|NCT01227564|Other Pre-specified|Change From Baseline in Dependence Scale (DS) Score|An abbreviated administration (first 6 items) of the DS was used in this study. The DS is a brief study partner-completed measure which assesses the degree of support required by a subject with AD. Since the goal of treatment was to delay or arrest the processes leading to increased dependence, the DS represented a meaningful endpoint for clinical studies in AD. The dependence score was derived by summing the first 6 items of the DS. Item 1 and 2 ranged from 0 – 2 and item 3 – 6 ranged from 0 – 1. The total score was calculated by summing the score from each of the 6 items. So the total score could range from 0 – 8, with higher scores indicating greater dependence.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.||score||Standard Deviation|Mean
830106|NCT01227564|Other Pre-specified|Change From Baseline in 13-item Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog) Total Score|The ADAS-Cog is a global cognitive measure. For the following 13 items, the participants were rated: Word Recall, Commands, Construction Praxis, Delayed Word Recall Task, Naming Task, Ideational Praxis, Orientation, Word Recognition Task, Remembering Test Instructions, Spoken Language Ability, Word-Finding Difficulty in Spontaneous Speech, Comprehension, and Number Cancellation. The ADAS-cog is a structured scale that evaluates memory, orientation, attention, reasoning, language and constructional praxis. The total score was the sum of the scores from the 13 individual items. This study used a modified 85 point scale with a scoring range of 0 to 85 (13 items). Higher scores of the 13 individual items indicated greater cognitive impairment.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.||score||95% Confidence Interval|Least Squares Mean
830107|NCT01227564|Other Pre-specified|Change From Baseline in Mini Mental State Examination (MMSE) Total Score|The MMSE is a brief, structured examination of cognitive function consisting of the 11 item: Orientation-What, Orientation-Where, Registration-Objects, Attention and Calculation, Recall, Language-Naming, Language-Repetition, Language-Comprehension, Language-Reading, Language-Writing, and Language- Drawing. MMSE total score was the sum of the 11 item scores and it ranges from 0 to 30 with higher score indicating greater cognitive functioning. If any individual item is missing, then the MMSE total score is set to missing. A positive change indicating an improvement from baseline.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.||score||95% Confidence Interval|Least Squares Mean
830108|NCT01227564|Other Pre-specified|Change From Baseline in NPI Distress Score (NPI-D)|The NPI scale assesses 12 domains (delusions, hallucinations, agitation, depression, anxiety, euphoria, apathy, disinhibition, irritability, aberrant motor behavior, nighttime behavior, and appetite and eating changes). The symptoms were rated on the basis of questions administered to the study partner. For each domain, the study partner also rated his/her own ‘emotional or psychological’ distress caused by the participant’s behavior on a 6-point scale. The study partner NPI-D total score was calculated by summing the scores of the 12 sub-scale distress scores. A negative change indicated an improvement from baseline. The caregiver distress (NPI-D) total score is calculated by summing the scores of the 12 sub-scale distress scores. The NPI-D total scores ranges from 0 to 60 with higher scores indicating greater distress.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.||score||95% Confidence Interval|Least Squares Mean
830109|NCT01227564|Other Pre-specified|Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score|The NPI scale assesses 12 domains (delusions, hallucinations, agitation, depression, anxiety, euphoria, apathy, disinhibition, irritability, aberrant motor behavior, nighttime behavior, and appetite and eating changes). The symptoms were rated on the basis of questions administered to the study partner. If a preliminary question for each domain was answered as ‘Yes’, each domain was rated on a 4-point frequency scale and on a 3-point severity scale. If the preliminary question was answered as ‘No’, the frequency, severity, and distress scales were set to zero. A negative change indicated an improvement from baseline. For each of the 12 domains, a sub-scale score is calculated as frequency*severity and ranges from 0 to 12. The NPI total score is then calculated by summing the scores of the 12 sub-scale scores. The NPI total scores ranges from 0 to 144 with higher scores indicating greater behavioral impairment. The caregiver distress score is not included in the NPI total score.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.||score||95% Confidence Interval|Least Squares Mean
830110|NCT01227564|Other Pre-specified|Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SOB)|Clinical Dementia Rating (CDR) is a global clinical staging instrument that was administrated by a trained rater to assess a participant’s level of impairment in six domains including: Memory, Orientation, Judgement and Problem Solving, Community Affairs, Home and Hobbies, and Personal Care, based on the CDR interview. The CDR included discussions with the participant and study partner using a structured format. A CDR-SOB score was derived based on individual scores from the six domains. A negative change indicated an improvement from baseline. The total CDR-SB score is calculated as the sum of the six clinical ratings. The CDR-SOB score range for each domain is 0 to 3. The CDR-SOB total score ranges from 0 to 18, with higher scores indicating greater dementia. If any individual item is missing, then the CDR-SB is set to missing.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.||score||95% Confidence Interval|Least Squares Mean
830140|NCT01227629|Secondary|Ecarin Clotting Time (ECT): Difference From Baseline||baseline and 12 weeks|All treated patients. No statistical comparisons due to high variability||seconds||Standard Deviation|Mean
830112|NCT01227564|Other Pre-specified|Change From Baseline in Neuropsychological Test Battery (NTB)|The NTB evaluated cognitive domains that are known to be affected early in the course of Alzheimer's disease (AD). The cognitive tests included in the NTB were: Rey Auditory Verbal Learning Test – Immediate recall, Detection, Identification, Go-No-Go Task, One Back Task, Controlled Oral Word Association Test, Category Fluency Test, and Rey Auditory Verbal Learning Test – delayed recall and recognition. For each of the eight NTB components, an individual z-score was derived based on the primary raw score of each test. Based on the individual z-scores, a composite z-score was derived using the formula: (z1-z2-z3-z4+z5+z6+z7+z8)/8. Positive change indicating an improvement from baseline.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.||z-scores||95% Confidence Interval|Least Squares Mean
830113|NCT01227564|Other Pre-specified|Change From Baseline in Volumetric Brain MRI Measurements in HBSI, Right|Right HBSI measures the right hippocampal atrophy from registered MRI scan pairs, by subtracting the corresponding area under the intensity profile across a boundary in the repeat scans.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.||mL||95% Confidence Interval|Least Squares Mean
830114|NCT01227564|Other Pre-specified|Change From Baseline in Volumetric Brain MRI Measurements in HBSI, Left|Left HBSI measures the left hippocampal atrophy from registered MRI scan pairs, by subtracting the corresponding area under the intensity profile across a boundary in the repeat scans.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.||mL||95% Confidence Interval|Least Squares Mean
830115|NCT01227564|Other Pre-specified|Change From Baseline in Volumetric Brain MRI Measurements in Hippocampal Boundary Shift Integral (HBSI), Total|Left HBSI and Right HBSI respectively measure the left hippocampal atrophy and the right hippocampal atrophy from registered MRI scan pairs, by subtracting the corresponding area under the intensity profile across a boundary in the repeat scans. HBSI (Total) is defined as the summation of the left HBSI and the right HBSI.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.||mL||95% Confidence Interval|Least Squares Mean
830116|NCT01227564|Other Pre-specified|Change From Baseline in Volumetric Brain MRI Measurements in Ventricular Boundary Shift Integral (VBSI)|VBSI measures ventricular volume change from registered MRI scan pairs, by subtracting the area under the intensity profile across a boundary in the repeat scans.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.||mL||95% Confidence Interval|Least Squares Mean
830117|NCT01227564|Other Pre-specified|Change From Baseline in Volumetric Brain Magnetic Resonance Imaging (MRI) Measurements in Brain Boundary Shift Integral (BBSI)|BBSI measures whole brain atrophy from registered MRI scan pairs, by subtracting the area under the intensity profile across a boundary in the repeat scans from the initial scan (baseline).|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.||mL||95% Confidence Interval|Least Squares Mean
830118|NCT01227564|Other Pre-specified|Change From Baseline in Plasma Aβ x-40|Site personnel collecting the samples for plasma Aβ (x-40) concentrations and the results were blinded to the participant treatment group assignment.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.||pg/mL||95% Confidence Interval|Least Squares Mean
830119|NCT01227564|Other Pre-specified|Change From Baseline in CSF Total Tau|For the majority of the participants, the lumbar puncture for the first CSF sample was collected up to 3 days prior to injection of investigational product. For the participants who had a CSF being already drawn at week 80, no CSF sample was drawn at week 104, nor at ET visit. For those participants who early terminated the study before week 80, CSF was drawn at ET visit.|Week 80 or Week 104|FAS population included all randomized participants who had at least one dose of investigational product.||μg/ml||95% Confidence Interval|Least Squares Mean
830120|NCT01227564|Other Pre-specified|Change From Baseline in CSF p-Tau|For the majority of the participants, the lumbar puncture for the first CSF sample was collected up to 3 days prior to injection of investigational product. For the participants who had a CSF being already drawn at week 80, no CSF sample was drawn at week 104, nor at ET visit. For those participants who early terminated the study before week 80, CSF was drawn at ET visit.|Week 80 or Week 104|FAS population included all randomized participants who had at least one dose of investigational product.||μg/ml||95% Confidence Interval|Least Squares Mean
830121|NCT01227564|Other Pre-specified|Change From Baseline in CSF Aβ x-42|For the majority of the participants, the lumbar puncture for the first CSF sample was collected up to 3 days prior to injection of investigational product. For the participants who had a CSF being already drawn at week 80, no CSF sample was drawn at week 104, nor at ET visit. For those participants who early terminated the study before week 80, CSF was drawn at ET visit.|Week 80 or Week 104|FAS population included all randomized participants who had at least one dose of investigational product.||μg/ml||95% Confidence Interval|Least Squares Mean
830122|NCT01227564|Other Pre-specified|Change From Baseline in Cerebrospinal Fluid (CSF) Aβ x-40|For the majority of the participants, the lumbar puncture for the first CSF sample was collected up to 3 days prior to injection of investigational product. For the participants who had a CSF being already drawn at week 80, no CSF sample was drawn at week 104, nor at the Early termination (ET) visit. For those participants who early terminated the study before week 80, CSF was drawn at ET visit.|Week 80 or Week 104|FAS population included all randomized participants who had at least one dose of investigational product.||μg/ml||95% Confidence Interval|Least Squares Mean
830123|NCT01227564|Primary|Change From Baseline in Brain Fibrillar Beta-Amyloid Protein (Aβ) at Week 104 as Measured by Standard Uptake Value Ratios (SUVRs) Over the Composite Regions of Interest (ROIs)|Fibrillar brain Aβ was measured by retention of florbetapir F18 as measured by positron emission tomography (PET) scans. A positive change indicating an improvement from baseline.|104 weeks|The full analysis set (FAS) population included all randomized participants who had at least one dose of investigational product.||ratio||95% Confidence Interval|Least Squares Mean
830141|NCT01227629|Secondary|11-dehydrothromboxane B2 (TXB2): Difference From Baseline|Difference from baseline to visit 7|baseline and 12 weeks|All treated patients. No statistical comparisons due to high variability||pg/mg Creatinine||Standard Deviation|Mean
830142|NCT01227629|Secondary|Soluble Fibrin: Difference From Baseline|Difference from baseline to visit 7|baseline and 12 weeks|All randomised patients, only per-protocol data included.||µg/ml||Standard Deviation|Mean
830124|NCT01227577|Secondary|Event-free Survival, Progression-free Survival and Overall Survival|Event-free survival was defined as the time from the date of enrollment to the date of first occurrence of any of the following: loss of Complete Hematological Response (CHR), loss of CCyR, loss of Partial Cytogenetic Response (PCyR), progression to the accelerated phase or blast crisis, and death from any cause. Progression-free survival was defined as the time from the date of enrollment to the date of first occurrence of any of the following: progression to the accelerated phase or blast crisis, death, and loss of CMR. Overall survival was defined as the time from the date of enrollment until death due to any cause.|4 years|Full Analysis Set (FAS): The FAS included all randomized participants who received at least one dose of study drug.||Months||95% Confidence Interval|Median
830125|NCT01227577|Secondary|Number of Participants With CMR Who Were Dosed to 400 mg b.i.d.|CMR was defined as at least 4.5 log reduction of breakpoint cluster region gene/Abelson proto-oncogene (Bcr-Abl) transcipts from the standardized baseline on the international scale (equivalent to Bcr-Abl <=0.0032% IS) with a minimum of 25,614 ABL control copies. CMR was to be confirmed by a second polymerase chain reaction (PCR) sample drawn 3 months later where the results should be less than or equal to 0.0032% with a minimum of 25,614 Abelson proto-oncogene (ABL) control copies.|4 years|Of the 128 participants analyzed, 3 participants received an escalated dose of 400 mg b.i.d.||Participants|||Number
830126|NCT01227577|Secondary|Number of Participants With Loss of CCyR, MMR and CMR|Rate of loss of CMR was defined as an increase in the Bcr-Abl transcripts to greater than 0.0032% IS. Rate of loss of CCyR was defined as an increase in the Ph+ bone marrow cells to greater than 0%. Rate of loss of MMR was defined as an increase in the Bcr-Abl transcripts to greater than 0.1% IS.|4 years|Numbers are based on the total number of participants who achieved and experienced loss of CMR (34 participants), CCyr (93 participants) and MMR (94 participants), respectively.||Participants|||Number
830127|NCT01227577|Secondary|Time to Progression of AP/BC|Time to progression of AP/BC was defined as the time from the date of the first dose of study drug to the date of first documented progression of AP/BC.|4 years|Of the 128 participants analyzed, 1 participant experienced progression to AP/BC.||Months||95% Confidence Interval|Median
830128|NCT01227577|Secondary|Number of Participants With Progression to Accelerated Phase/Blastic Crisis (AP/BC)|Progression to AP/BC is defined as loss of CCyR, MMR, and CMR and was summarized by frequencies and percentages.|4 years|Full Analysis Set (FAS): The FAS included all randomized participants who received at least one dose of study drug.||Participants|||Number
830129|NCT01227577|Secondary|Duration of CMR, CCyR and MMR|Duration of CMR, CCyR and MMR were defined as the time from the first date of achievement of the response to the date of first documented loss of the response.|4 years|Of the 128 participants analyzed, 34 participants achieved CMR within 18 months of treatment, 93 participants achieved CCyR and did not experience loss of CCyR during the study, and 94 participants achieved MMR with up to 24 months of treatment (most achieved MMR within 12 months of treatment).||Months||Standard Deviation|Mean
830130|NCT01227577|Secondary|Time to CMR, CCyR and MMR|Time to CMR, CCyR, and MMR was defined as the time from the date of enrollment to the date of first documented CMR, CCyR and MMR, respectively.|4 years|Of the 128 participants analyzed, 34 participants achieved CMR within 18 months of treatment, 93 participants achieved CCyR and did not experience loss of CCyR during the study, and 94 participants achieved MMR with up to 24 months of treatment (most achieved MMR within 12 months of treatment).||Months||95% Confidence Interval|Median
830131|NCT01227577|Secondary|Number of Participants With Complete Cytogenetic Response (CCyR) and Major Molecular Response (MMR)|"CCyR was defined as 0% Philadelphia chromosome-positive (Ph+) metaphases in the bone marrow. MMR was defined as a 3 log reduction of Bcr-Abl transcripts from the standardized baseline on the international scale (equivalent to Bcr-Abl ≤ 0.1% IS).
Bcr-Abl transcripts assessed by peripheral blood quatitative real time polymerase chain reaction (RQ-PCR) were used for the determination of all molecular responses."|4 years|Full Analysis Set (FAS): The FAS included all randomized participants who received at least one dose of study drug.||Participants|||Number
830132|NCT01227577|Primary|Number of Participants With Confirmed Complete Molecular Response (CMR)|CMR was defined as at least 4.5 log reduction of breakpoint cluster region gene/Abelson proto-oncogene (Bcr-Abl) transcipts from the standardized baseline on the international scale (equivalent to Bcr-Abl <=0.0032% IS) with a minimum of 25,614 ABL control copies. CMR was to be confirmed by a second polymerase chain reaction (PCR) sample drawn 3 months later where the results should be less than or equal to 0.0032% with a minimum of 25,614 Abelson proto-oncogene (ABL) control copies.|4 years|Full Analysis Set (FAS): The FAS included all randomized participants who received at least one dose of study drug.||Participants|||Number
830133|NCT01227629|Secondary|Severity of Adverse Events|Total number of patients with any adverse event of worst intensity 'mild', 'moderate' and 'severe'.|12 weeks|Treated patients(Numbers of patients for adverse events are counted for each treatment and are in their sum greater than the total number of patients randomized as 14 patients on Dabigatran with ASA changed treatment,12 patients down titrated Dabigatran bid to qd of which one did the down titration at the same time as the stop of the ASA treatment)||participants|||Number
830134|NCT01227629|Secondary|Number of Participants With Increase of Alanine-Aminotransferase (ALT) to >2*Baseline|Number of Participants with Increase of ALT to more than two times the baseline value|12 weeks|All treated patients. No statistical comparisons due to extremely small number of cases||Participants|||Number
830135|NCT01227629|Secondary|Number of Participants With Increase of Bilirubin to >2*Baseline|Increase of Bilirubin to more than two times the baseline value|12 weeks|All treated patients. No statistical comparisons due to extremely small number of cases||Participants|||Number
830136|NCT01227629|Secondary|Number of Participants With Increase of Alkaline Phosphatase (AP) to >2*Baseline|Increase of AP to more than two times the baseline value|12 weeks|All treated patients. No statistical comparisons due to extremely small number of cases||Participants|||Number
830137|NCT01227629|Secondary|Number of Participants With Increase of Aspartat-Aminotransferase (AST) to >2*Baseline|Increase of AST to more than two times the baseline value|12 weeks|All treated patients. No statistical comparisons due to extremely small number of cases||Participants|||Number
830138|NCT01227629|Secondary|Trough Plasma Concentration of Dabigatran (BIBR 953)|The values of the trough plasma concentration of dabigatran (BIBR 953) are the by-patient geometric means of week 1, 4 and 12.|12 weeks|All treated patients||ng/ml||Standard Deviation|Mean
830139|NCT01227629|Secondary|Activated Partial Thromboplastin Time (aPTT): Difference From Baseline||baseline and 12 weeks|All treated patients. No statistical comparisons due to high variability||seconds||Standard Deviation|Mean
830150|NCT01227629|Secondary|Number of Participants With Thromboembolic Events: Composite Endpoint|Combination of ischemic stroke (fatal or non fatal), transient ischemic attack, systemic thromboembolism, myocardial infarction (fatal or non fatal), other major adverse cardiac event and all cause mortality|12 weeks|All randomized patients. No statistical comparisons were performed, due to the extremely small number of events.||Participants|||Number
830151|NCT01227629|Primary|Number of Participants With Minor/Nuisance Bleeding Events|All bleeding events not fulfilling one of the criteria for major bleeding event or minor/relevant bleeding events.|12 weeks|All treated patients. No statistical comparisons were performed, due to the small number of events per group||Participants|||Number
830152|NCT01227629|Primary|Number of Participants With Minor/Relevant Bleeding Events|Haematuria, rectal bleeding, gingival bleeding, skin hematoma of 25cm^2 or more, nose bleed of more than 5 minutes duration, bleeding leading to a hospitalization, leading to a transfusion of less than 2 units or any other clinically relevant bleeding|12 weeks|All treated patients. No statistical comparisons were performed, due to the small number of events per group||Participants|||Number
830153|NCT01227629|Primary|Number of Participants With Fatal or Life-threatening Major Bleeding Events|Retroperitoneal, intracranial, intraocular, or intraspinal bleeding, or requiring surgical treatment, or leading to a transfusion of 2 units or more, or leading to a fall in hemoglobin of 20g/L or more|12 weeks|All treated patients. No statistical comparisons were performed, due to the extremely small number of events.||Participants|||Number
830154|NCT01227655|Secondary|Non-motor Symptoms Scale (NMSS)|"The Non-motor Symptoms Scale (NMSS) consists of 30 questions, covering 9 dimensions, whereby each item is scored for severity and frequency: Severity None 0 Mild (symptoms present but causes little distress) 1 Moderate (some distress or disturbance to subject) 2 Severe (major source of distress or disturbance to subject) 3
Frequency Rarely (<1/wk) 1 Often (1/wk) 2 Frequent (several times per week) 3 Very Frequent (daily or all the time) 4
The product of frequency and severity is calculated for each item and each dimension score is defined as the sum of the frequency*severity of the respective items. If frequency or severity of a single item is missing, the domain score will not be calculated. The NMSS total score is defined as the sum of all domain scores.
The NMSS total score is calculated by adding all domain scores (0–360), and lower scores mean less disability."|14-15 weeks|||units on a scale||Standard Deviation|Mean
830155|NCT01227655|Secondary|Parkinson’s Disease Sleep Scale (PDSS)|"The Parkinson’s disease Sleep Scale (PDSS) is a specific scale for the assessment of sleep disturbances in subjects with PD. The PDSS score is calculated as the sum of all single items. If one or two items are missing, they will be imputed with the mean of the non-missing items. If three or more items are missing, no imputation will be done and the score will be set to missing.
Subscale has 0-10 ratings, where 0 = severe and 10 = normal
The PDSS total score is a sum score of all 15 questions and ranges from 0 to 150, with lower scores meaning more disability."|14-15 weeks|||units on a scale||Standard Deviation|Mean
830156|NCT01227655|Secondary|UPDRS (Unified Parkinson’s Disease Rating Scale) Sections I (ON), II (ON and OFF), and III (ON)|"Total UPDRS SCORE (I, II (ON), and III) Change from Baseline to Endpoint
UPDRS I evaluation of mentation, behavior, and mood
UPDRS II self-evaluation of the activities of daily life (ADLs) including speech, swallowing, handwriting, dressing, hygiene, falling, salivating, turning in bed, walking, and cutting food
UPDRS III clinician-scored monitored motor evaluation The UPDRS I, II and III scores and subscores are calculated as the sum of all individual items. If one or two items in a scale are missing, they will be imputed with the mean of the non-missing items of that scale.
Subscale has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe
The final cumulative score will range from 0 (no disability) to 199 (total disability)."|14-15 weeks|||units on a scale||Standard Deviation|Mean
830157|NCT01227655|Primary|Efficacy of 2 BIA 9-1067 (25 mg, and 50 mg) Compared With Placebo, When Administered With the Existing Treatment of L-DOPA Plus a DDCI (DOPA Decarboxylase Inhibitor)|Efficacy of 2 BIA 9-1067 (25 mg, and 50 mg) compared with placebo, when administered with the existing treatment of L-DOPA plus a DDCI (DOPA decarboxylase inhibitor), in patients with PD and end-of-dose motor fluctuations. The primary efficacy variable will be the change from baseline in absolute OFF-time at the end of the DB period.|14-15 weeks|||minutes||Standard Deviation|Mean
830158|NCT01227668|Other Pre-specified|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Treatment-related AEs During Phase 2|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug.|Weekly from Weeks 1 through 16 (end of treatment) of Phase 2|All participants who were randomized and took at least 1 dose of double-blind medication in Phase 2||Participants|||Number
830159|NCT01227668|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), and Adverse Events (AEs) Leading to Discontinuation During Phase 1|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|Weekly from Week 1 to Week 26 and continuously to end of treatment|All participants who took at least 1 dose of single-blind aripiprazole in Phase 1||Participants|||Number
830170|NCT01227707|Secondary|Percentage of Participants With Relapse During Follow-Up|The percentage of participants with local and/or regional relapse during follow-up. New lesions located at rectum or at colon or at lymph node detected at the end of NAT were evaluated as local and/or regional relapse.|BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until progression, up to 45 months|ITT population; only participants who underwent radical surgery were included in the analysis||percentage of participants|||Number
830171|NCT01227707|Secondary|Percentage of Participants With New Lesions at the Primary Tumor Site at the End of Neoadjuvant Treatment|The percentage of participants with new lesions located at the primary tumor site were evaluated at the end of NAT.|BL and within 6 weeks after the completion of study treatment|ITT population||percentage of participants|||Number
839448|NCT01325181|Secondary|Change From Baseline in logMAR BCVA|the changes from baseline in logMAR BCVA throughout the follow-up period|12 months||||||
830160|NCT01227668|Secondary|Change From Baseline in Mean Clinical Global Impression Improvement (CGI-I) Scale Score at Week 16 (Last Observation Carried Forward [LOCF])|CG-I rating scale permits global evaluation of patient’s improvement over time. At baseline (BL), CGI Severity of Illness assessment is performed, in which the clinician rates severity of patient’s condition on a 7-point scale ranging from 1=no symptoms to 7=very severe symptoms. Higher total score=worse symptoms. At subsequent visits, clinician assesses patient’s improvement relative to symptoms at baseline on CGI-I 7-point scale ranging from 1=very much improved to 7=very much worse. Since the drug targets irritability symptoms, the CGI focuses on severity of irritability secondary to autistic disorder. Lower score=more improved symptoms. LOCF data set includes data recorded at a given visit or, if nothing recorded, data areccarried forward from the prior visit. For secondary endpoints (endpt), hierarchical testing was used to keep overall experiment-wise type I error rate to <=0.05. diff=difference; IS=irritability scale; PA=primary analysis; signif=significance/significantly.|From Baseline (end of Phase 1) to Week 16 of Phase 2|All participants who were randomized and took at least 1 dose of double-blind medication in Phase 2 and who had at least 1 efficacy evaluation after the start of Phase 2 study drug.||Units on a scale||Standard Error|Mean
830161|NCT01227668|Secondary|Adjusted Mean Change From Baseline to Week 16 on the Aberrant Behavior Checklist Irritability (ABC-I) Subscale Score (Last Observation Carried Forward [LOCF])|ABC is an informant-based checklist used to assess and classify problem behaviors of children and adolescents with mental retardation. The 58 items are rated on a 4-point scale (0=not at all a problem to 3=the problem is severe in degree), and resolve into 5 subscales: 1) irritability, agitation; 2) lethargy, social withdrawal; 3) stereotypic behavior; 4) hyperactivity, noncompliance; and 5) inappropriate speech. The ABC can be completed by parents, special educators, psychologists, direct caregivers, nurses, and others knowing the participant. Psychometric assessment of the ABC indicates that its subscales have high internal consistency, adequate reliability, and established validity. The ABC-I Subscale Score ranges from 0 to 45, with a negative change in score signifying improvement. LOCF data set includes data recorded at a given visit or, if no observation was recorded at that visit, data carried forward from the prior visit. chg=change; BL=baseline; APR=aripiprazole; vs=versus.|From Baseline (end of Phase 1) to Week 16 of Phase 2|All participants who were randomized and took at least 1 dose of double-blind medication in Phase 2 and who had at least 1 efficacy evaluation after the start of Phase 2 study drug.||Units on a scale||Standard Error|Mean
830162|NCT01227668|Primary|Percentage of Patients Relapsing by Week 16|"Time of relapse=date when patient meets relapse criteria. There are 4 definitions for relapse: 1. Patient meets the following criteria for 2 consecutive visits: (a) Aberrant Behavior Checklist Irritability score ≥25% than score at end of Phase 1 AND (b) Clinical Global Impression Improvement scale rating of ‘Much Worse’ or ‘Very Much Worse’ relative to rating at end of Phase 1. If relapse criteria met at 1 visit, 2nd visit should occur in about 1 week to reevaluate whether relapse criteria are still met. 2. Patient discontinues for Lost to Follow-up after a visit in which he or she met Definition 1 criteria (a&b). 3. Patient begins a prohibited drug (whether a study investigator or outside source prescribed) to treat worsening symptoms of irritability of autistic disorder after a visit where patient met Definition 1 criteria (a&b). 4. Patient discontinues due to hospitalization for worsening symptoms of irritability or due to lack of efficacy based on investigator’s assessment."|From end of Phase 1 (Date of randomization) to Week 16 of Phase 2 and end of treatment|All participants who were randomized in Phase 2||Percentage of participants|||Number
830163|NCT01227681|Primary|Motor Performance of Unified Parkinson's Disease Rating Scale|To assess Unified Parkinson's Disease Rating Scale part III (motor function) scores from baseline Medication-off status to Medication-off status after G-CSF injection one year. Scores of UPDRS Part III ranges from 0 to 108 and higher values indicate worse outcome.|2 years|||scores on a scale||Full Range|Mean
830164|NCT01227707|Secondary|TTP - Time to Event|TTP was defined as the time from date of treatment start until first documented progression of disease or death due to underlying cancer. TTP was estimated using the Kaplan-Meier method.|BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until death, up to 45 months|ITT population||months||Standard Deviation|Mean
830165|NCT01227707|Secondary|Time to Disease Progression (TTP) - Percentage of Participants With an Event|TTP was defined as the time from date of treatment start until first documented progression of disease or death due to underlying cancer.|BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until death, up to 45 months|ITT population||percentage of participants|||Number
830166|NCT01227707|Secondary|OS - Time to Event|OS was defined as the time from the date of first day of treatment until death due to any cause or the last date the participant was known to be alive. OS was estimated using the Kaplan-Meier method.|BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until death, up to 45 months|ITT population||months||Standard Deviation|Mean
830167|NCT01227707|Secondary|Overall Survival (OS) - Percentage of Participants With an Event|OS was defined as the time from the date of first day of treatment until death due to any cause or the last date the participant was known to be alive.|BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until death, up to 45 months|ITT population||percentage of participants|||Number
830168|NCT01227707|Secondary|DFS - Time to Event|The time in months from date of start-of-treatment to the date of event defined as the first documented disease progression or death due to any cause. If a participant did not have an event, the time was censored at the date of last adequate tumor assessment. DFS was estimated using the Kaplan-Meier method.|BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until progression, up to 45 months|ITT population||months||Standard Deviation|Mean
830169|NCT01227707|Secondary|Disease-Free Survival (DFS) - Percentage of Participants With an Event|DFS was defined as the time from treatment start date to the date of first progression of disease or date of death due to any cause.|BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until progression, up to 45 months|ITT population||percentage of participants|||Number
830209|NCT01227785|Primary|Clinical Performance at Implant for Right Atrium (RA) Sensing Amplitude|RA Sensed Amplitude results were reported for implant for CRT-D and ICD patients|implant|55 CRT-D patients and 11 ICD patients had available data at implant.||milli volt (mV)||Standard Deviation|Mean
830172|NCT01227707|Secondary|Percentage of Participants With an Overall Response of CR at the End of Neoadjuvant Treatment|Percentage of participants with an overall response of CR was evaluated as the proportion of participants with CR for the target and non-target lesions plus absence of new lesions at the end of NAT according to RECIST. CR was defined as disappearance of all target lesions, all non-target lesions, and normalization of tumor marker levels.|BL and within 6 weeks after the completion of study treatment|ITT population||percentage of participants|||Number
830173|NCT01227707|Secondary|Percentage of Participants With Complete Response (CR) at the End of Neoadjuvant Treatment|Percentage of participants with CR was evaluated as the proportion of participants with complete response for the target and non-target lesions, separately, at the end of NAT according to the Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as disappearance of all target lesions or all non-target lesions and normalization of tumor marker levels.|BL and within 6 weeks after the completion of study treatment|ITT population||percentage of participants|||Number
830174|NCT01227707|Secondary|Percentage of Participants Undergoing Sphincter-Saving Surgery by Type of Procedure||6 to 8 weeks after completion of study treatment|ITT population; only participants who underwent surgery were included in the analysis. n (number) equals (=) number of participants assessed for the specified parameter (colostomy)||percentage of participants|||Number
830175|NCT01227707|Secondary|Percentage of Participants by Primary Tumor (T), Regional Lymph Nodes (N), and Distant Metastasis (M) Clinical Stage at Baseline and at the End of Neo-Adjuvant Treatment (NAT)|The frequencies of clinical tumor stage T (0, 1, 2, 3, 4, or X), regional lymph nodes stage N (0, 1, 2, 3, or 4), and distant metastasis clinical stage M (0, 1, or X) at baseline and at the end of NAT were assessed. The frequencies of pathological tumor stage T and regional lymph nodes stage N at surgery were evaluated. The clinical tumor and lymph node status was assessed by clinical examination, endosonography, and/or rectosigmoidoscopy, and pelvic and abdomen computerized tomography (CT) scan or magnetic resonance imaging (MRI). Response to treatment had to be assessed within 6 weeks after end of treatment by using the same techniques performed at baseline.|Baseline (BL) and end of neoadjuvant treatment (within 6 weeks after the completion of study treatment)|ITT population||percentage of participants|||Number
830176|NCT01227707|Primary|Percentage of Participants With Pathological Complete Response (pCR)|pCR was defined as the absence of viable tumor cells, as determined by standard histologic procedure, in the tumor specimen (including regional lymph nodes) obtained at surgery. In order to minimize evaluation bias, tumor specimens were analyzed by both a central and local pathologist. The number of participants with pathological tumor stage 0 (pT0) and regional lymph nodes stage 0 (pN0) at surgery was determined. pCR was defined as the number of participants with pT0 and pN0 at surgery divided by the total number of participants with pathological tumor stage data collected.|6 to 8 weeks following completion of neoadjuvant treatment|ITT population; only participants who underwent surgery and had pathological tumor stage data were included in the analysis.||percentage of participants||95% Confidence Interval|Number
830177|NCT01227785|Primary|Wanded Telemetry Issues at Pre-discharge Follow-up|The Investigators completed a questionnaire based on the performance of the wanded telemetry during device interrogations at pre-discharge follow-up. The number of problems reported were counted from the entire study cohort.|Pre-Discharge visit occurred after implant but prior to 1 month follow-up visit|118 was the total number of questionnaires completed and available from the PI for analysis.||issues|||Number
830178|NCT01227785|Primary|Spontaneous Episode Conversion Success Rate at 3 Months|Of the total patients that experienced a spontaneous episode, the % of patients with a spontaneous rhythm conversion that was successful was determined.|3-month|Of the 13 CRT-D and 8 ICD patients that experienced a spontaneous episode, the successful conversions were reported.||percentage of successful conversions|Participants||Number
830179|NCT01227785|Primary|Induced Episode Detection Times at 3 Months|The mean time it took to complete a successful conversion after inducing a VT/VF episode was analyzed for available data from CRT and ICD group patients. The time was recorded (in seconds) for the time duration that was required to successfully convert the patient after inducing VT/VF.|3-month|Of the 6 CRT-D and 3 ICD patients with available data that had succesful conversion after induced VT/VF episodes, the mean time was determined at 3 months||seconds||Standard Deviation|Mean
830180|NCT01227785|Primary|Induced Episode Detection Times at 1-month|The mean time it took to complete a successful conversion after inducing a VT/VF episode was analyzed for available data from CRT and ICD group patients. The time was recorded (in seconds) for the time duration that was required to successfully convert the patient after inducing VT/VF.|1-month|Of the 1 CRT-D and 1 ICD patients that underwent induced VT/VF at 1month, the mean time for successful conversion was reported.||seconds||Standard Deviation|Mean
830181|NCT01227785|Primary|Induced Episode Detection Times at Implant|The mean time it took to complete a successful conversion after inducing a VT/VF episode was analyzed for available data from CRT and ICD group patients. The time was recorded (in seconds) for the time duration that was required to successfully convert the patient after inducing VT/VF.|implant|Of the 30 CRT-D and 22 ICD patients with induced VT/VF episodes, the mean time required for conversion was reported for all available data||seconds||Standard Deviation|Mean
830182|NCT01227785|Primary|Induced VT/VF Episode Successful Conversion Rates at 3-months|The % of successful conversions after inducing a VT/VF episode was analyzed for available data from CRT and ICD group patients. All episodes of induced VT/VF that resolved with successful conversion were counted from the total attempted conversions and reported as the % of successful conversions from those attempted.|3-month|Of the 6 CRTD and 3 ICD patients that had induced VT/VF episodes at 3-month follow-up, the number of those that were converted successfully was reported in %||percentage of successful conversions|||Number
830183|NCT01227785|Primary|Induced VT/VF Episode Successful Conversion Rates at 1-month|The % of successful conversions after inducing a VT/VF episode was analyzed for available data from CRT and ICD group patients. All episodes of induced VT/VF that resolved with successful conversion were counted from the total attempted conversions and reported as the % of successful conversions from those attempted.|1-month|Of all patients that experienced an induced VT/VF episode at 1-month, the number that had successful conversions was reported for both CRT-D and ICD patients.||percentage of successful conversions|||Number
830210|NCT01227785|Primary|Clinical Performance at1-month for Left Ventricular (LV) Sensing Amplitude for CRT-D Patients|LV Sensed Amplitude results were reported at 1-month post-implant for CRT-D patients.|1-month|68 patients in the CRT-D cohort had available data at 1month visit||milli volt (mV)||Standard Deviation|Mean
830184|NCT01227785|Primary|Induced Ventricular Tachycardia / Ventricular Fibrillation (VT/VF) Episode Successful Conversion Rates at Implant|The % of successful conversions after inducing a VT/VF episode was analyzed for available data from CRT and ICD group patients. All episodes of induced VT/VF that resolved with successful conversion were counted from the total attempted conversions and reported as the % of successful conversions from those attempted.|implant|Of the 30 CRT-D and 22 ICD patients with induced episodes, the number with successful conversions was determined. The % of patients that had successful conversion was then reported.||percentage of successful conversions|||Number
830185|NCT01227785|Primary|Product Experiences Reported by the Site for All Patients for Study Duration|Product experiences reported may include the shock impedance noise display, problems encountered with the universal serial bus (USB), a program parameter mismatch, reverse mode switches, electrogram (EGM) noise without oversensing, lead connection issues, or customer device feedback.|Overall study results|All patients from overall study population were considered. Of the total population, the number of product experiences was reported.||experiences|||Number
830186|NCT01227785|Primary|Clinical Performance at 1-month for RA Pacing Impedance|RA pacing impedance results were reported at 1-month post-implant|1-month|54 CRT-D and 11 ICD patients had data available at 1-month||Ohms||Standard Deviation|Mean
830187|NCT01227785|Primary|Clinical Performance at Pre-discharge for RA Pacing Impedance|RA pacing impedance results were reported at pre-discharge|pre-discharge|57 CRT-D and 11 ICD patients had data available at pre-discharge||Ohms||Standard Deviation|Mean
830188|NCT01227785|Primary|Clinical Performance at Implant for RA Pacing Impedance|RA pacing impedance results were reported at implant|implant|56 CRT-D and 11 ICD patients had data available at implant||Ohms||Standard Deviation|Mean
830189|NCT01227785|Primary|Clinical Performance at 1-month for RV Pacing Impedance|RV pacing impedance results were reported at 1-month post-implant|1-month|75 CRT-D and 43 ICD patients had data available at 1-month visit||Ohms||Standard Deviation|Mean
830190|NCT01227785|Primary|Clinical Performance at Pre-discharge for RV Pacing Impedance|RV pacing impedance results were reported for pre-discharge|pre-discharge|78 CRT-D and 45 ICD patients had data available at pre-discharge||Ohms||Standard Deviation|Mean
830191|NCT01227785|Primary|Clinical Performance at Implant for RV Pacing Impedance|RV pacing impedance results were reported at implant|implant|79 CRT-D and 46 ICD patients had data available at implant||Ohms||Standard Deviation|Mean
830192|NCT01227785|Primary|Clinical Performance at 1-month for LV Pacing Impedance for CRT-D.|LV pacing impedance results were reported at 1-month post-implant|1-month|73 CRT-D patients had data available at 1-month visit||Ohms||Standard Deviation|Mean
830193|NCT01227785|Primary|Clinical Performance at Pre-discharge for LV Pacing Impedance for CRT-D.|LV pacing impedance results were reported for pre-discharge visit|pre-discharge|75 CRT-D patients had data available at pre-discharge||Ohms||Standard Deviation|Mean
830194|NCT01227785|Primary|Clinical Performance at Implant LV Pacing Impedance for CRT-D.|LV pacing impedance results at implant were measured in CRT-D.|implant|78 CRT-D patients had data available at implant||Ohms||Standard Deviation|Mean
830195|NCT01227785|Primary|Clinical Performance at 1-month for RA Pacing Threshold|RA pacing threshold results were reported at 1-month post-implant|1-month|54 CRT-D and 11 ICD patients had data available at 1-month visit||volts (V)||Standard Deviation|Mean
830196|NCT01227785|Primary|Clinical Performance at Pre-discharge for RA Pacing Threshold|RA pacing threshold results were reported at pre-discharge|pre-discharge|57 CRT-D and 11 ICD patients had data available at pre-discharge||volts (V)||Standard Deviation|Mean
830197|NCT01227785|Primary|Clinical Performance at Implant for RA Pacing Threshold|RA pacing threshold results were reported for implant|implant|56 CRT-D and 11 ICD patients had data available at implant||volts (V)||Standard Deviation|Mean
830198|NCT01227785|Primary|Clinical Performance at 1-month for RV Pacing Threshold|RV pacing threshold results were reported at 1-month post-implant|1-month|75 CRT-D and 43 ICD patients had data available at 1-month visit.||volts (V)||Standard Deviation|Mean
830199|NCT01227785|Primary|Clinical Performance at Pre-discharge for RV Pacing Threshold|RV pacing threshold results were reported at pre-discharge|pre-discharge|78 CRT-D and 45 ICD patients had data available at pre-discharge||volts (V)||Standard Deviation|Mean
830200|NCT01227785|Primary|Clinical Performance at Implant for RV Pacing Threshold|RV pacing threshold results were reported at implant|implant|79 CRT-D and 46 ICD patients had data available at implant.||volts (V)||Standard Deviation|Mean
830201|NCT01227785|Primary|Clinical Performance at1-month for LV Pacing Threshold|LV pacing threshold results were reported at 1-month post-implant for CRT-D patients.|1-month|73 CRT-D patients had data available at 1-month visit.||volts (V)||Standard Deviation|Mean
830202|NCT01227785|Primary|Clinical Performance at Pre-discharge for LV Pacing Threshold|LV pacing threshold results were reported at pre-discharge for CRT-D patients.|pre-discharge|75 patients had data available at pre-discharge||volts (V)||Standard Deviation|Mean
830203|NCT01227785|Primary|Clinical Performance at Implant for LV Pacing Threshold|LV pacing threshold results were reported for CRT-D patients at implant.|implant|78 CRT-D patients had data available at implant.||volts (V)||Standard Deviation|Mean
830204|NCT01227785|Primary|Clinical Performance at1-month for Right Ventricle (RV) Sensing Amplitude|RV Sensed Amplitude results were reported at 1-month post-implant for CRT-D and ICD patients|1month|68 CRT-D and 43 ICD patients had data available at 1month visit.||milli volt (mV)||Standard Deviation|Mean
830205|NCT01227785|Primary|Clinical Performance at Pre-discharge for Right Ventricle (RV) Sensing Amplitude|RV Sensed Amplitude results were reported at pre-discharge for CRT-D and ICD patients|pre-discharge|73 CRT-D and 44 ICD patients had data available at pre-discharge visit.||milli volt (mV)||Standard Deviation|Mean
830206|NCT01227785|Primary|Clinical Performance at Implant for Right Ventricle (RV) Sensing Amplitude|RV Sensed Amplitude results were reported at implant for CRT-D and ICD patients|implant|74 CRT-D and 45 ICD patients had data available at implant||milli volt (mV)||Standard Deviation|Mean
830207|NCT01227785|Primary|Clinical Performance at1-month for RA Sensing Amplitude|RA Sensed Amplitude results were reported at 1-month post-implant for CRT-D and ICD patients|1-month|53 CRT-D and 11 ICD patients had data available at 1-month visit.||milli volt (mV)||Standard Deviation|Mean
830208|NCT01227785|Primary|Clinical Performance at Pre-discharge for RA Sensing Amplitude|RA Sensed Amplitude results were reported at pre-discharge for CRT-D and ICD patients|pre-discharge|55 CRT-D and 11 ICD patients had data available at pre-discharge visit.||milli volt (mV)||Standard Deviation|Mean
830211|NCT01227785|Primary|Clinical Performance at Pre-discharge for LV Sensing Amplitude for CRT-D Patients|Left Ventricular (LV) Sensed Amplitude results were reported pre-discharge for CRT-D patients.|pre-discharge|69 patients in the CRT-D arm had available data at pre-discharge visit.||milli volt (mV)||Standard Deviation|Mean
830212|NCT01227785|Secondary|Evaluate the Daily Median Respiratory Rate Trend in Patients Who Experience a HF-event Compared to Patients Who do Not Experience a HF-event.|A comparison of the change in respiratory rate trend over time was made between patients who experienced a protocol-defined HF event (HFE) (Group1: Patients with a HFE) and patients who did not experience a protocol-defined heart failure event (Group 2: Patients without a HFE). Only patients with at least 3 valid daily respiratory rate values (60%) out of each 5-day window were evaluated. The objective was to show that daily median respiratory rate increases more in patients who experience a HFE (Group 1) than in patients who do not experience an HFE (Group 2). A comparison between patients who experience a HFE (Group 1) and patients who do not experience a HFE (Group 2). Two average daily median respiratory rates were done per patient: 60 to 56 days before an index time and 11 to 7 days before the same index time; the difference between these two averaged daily median respiratory rates was done. Index time=day of the first HFE (Group 1) and day of 6-month visit (Group 2).|Results were captured from implant time window to the first event for patients with HFE, up to an average of 9 months|HF events were reported and adjudicated to classify patients into group 1 or 2. Group 1=17 HFEs in 13 patients. For patients with multiple HFEs,only the first with sufficient data was used. 8/13 with a HFE had data for the endpoint analysis.Group 2=95 patients with 9 month follow-up. 90/95 had data eligible for inclusion in the endpoint analysis.||breaths/min||Inter-Quartile Range|Median
830213|NCT01227785|Primary|Clinical Performance for Left Ventricular (LV) Sensing Amplitude at Implant for CRT-D Patients|Left Ventricular (LV) Sensed Amplitude results were reported at implant for CRT-D patients.|implant|The number of CRT-D patients with available data at implant||milli volt (mV)||Standard Deviation|Mean
830214|NCT01227824|Secondary|Cmax and Ctau of DTG|The maximum plasma concentration (Cmax) and concentration at the end of a dosing interval (Ctau) of DTG were assessed at Week 48. The predicted individual Cmax and Ctau were obtained from the final population PK model by simulation of the concentration-time profiles. Blood samples for pharmacokinetic assessments were collected at pre-dose (within 15 minutes prior to dose) at Week 4, Week 24, and Week 48 and 1 to 3 hours post-dose or 4 to 12 hours post-dose at Week 4 and Week 24. If 1 to 3 hour post-dose was completed at Week 4, then the 4 to12 hour post-dose must be obtained at Week 48, and vice versa.|Week 4, Week 24, and Week 48|The Pharmacokinetic (PK) Concentration Population: all participants who received DTG, had undergone PK sampling during the study, and provided evaluable DTG plasma concentration data.||Micrograms per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
830215|NCT01227824|Secondary|AUC(0-tau) of DTG|AUC is defined as the area under the DTG concentration-time curve as a measure of drug exposure over time. AUC(0-tau) is defined as the area under the plasma concentration-time curve from time zero to time tau over a dosing interval at steady state, where tau is the length of the dosing interval of DTG. The predicted individual AUC(0-tau) were obtained from the final population PK model by an empirical Bayes estimation. Blood samples for pharmacokinetic assessments were collected at pre-dose (within 15 minutes prior to dose) at Week 4, Week 24, and Week 48 and 1 to 3 hours post-dose or 4 to 12 hours post-dose at Week 4 and Week 24. If 1 to 3 hours post-dose was completed at Week 4, then the 4 to12 hour post-dose must be obtained at Week 48, and vice versa. AUC was estimated using population PK modeling based on PK data from all visits.|Week 4, Week 24, and Week 48|The Pharmacokinetic (PK) Concentration Population: all participants who received DTG, had undergone PK sampling during the study, and provided evaluable DTG plasma concentration data.||Micrograms*hour per milliliter(µg*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
830216|NCT01227824|Secondary|Number of Participants With the Indicated Grade 1 to 4 Clinical Chemistry and Hematology Toxicities/Laboratory Adverse Events (AEs)|All Grade 1 to 4 post-Baseline-emergent chemistry toxicities included alanine aminotransferase (ALT), alkaline phosphatase (ALP), asparate aminotransferase (AST), carbon dioxide (CO2) content/bicarbonate, cholesterol, creatine kinase (CK), creatinine, hyperglycemia, hyperkalemia, hypernatremia, hypoglycemia, hypokalemia, hyponatremia, low density lipoprotein (LDL) cholesterol calculation, lipase, phosphorus inorganic, total bilirubin, and triglycerides. All Grade 1 to 4 post-Baseline-emergent hematology toxities included hemoglobin, platelet count, total neutrophils, and white blood cell count. The Division of AIDS (DAIDS) defined toxicity grades as follows: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening; Grade 5, death.|From Baseline until Week 96|Safety Population: all participants who received at least one dose of investigational product||Participants|||Number
830217|NCT01227824|Secondary|Number of Participants With the Indicated Post-baseline HIV-associated Conditions and Progression, Excluding Recurrences|Clinical disease progression (CDP) was assessed according to the Centers for Disease Control and Prevention (CDC) HIV-1 classification system. Category (CAT) A: one or more of the following conditions (CON), without any CON listed in Categories B and C: asymptomatic HIV infection, persistent generalized lymphadenopathy, acute (primary) HIV infection with accompanying illness or history of acute HIV infection. CAT B: symptomatic CON that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or that are considered by physicians to have a clinical course or to require management that is complicated by HIV infection; and not included among CON listed in clinical CAT C. CAT C: the clinical CON listed in the AIDS surveillance case definition. Indicators of CDP were defined as: CDC CAT A at Baseline (BS) to a CDC CAT C event (EV); CDC CAT B at BS to a CDC CAT C EV; CDC CAT C at BS to a new CDC CAT C EV; or CDC CAT A, B, or C at BS to death.|From Baseline until Week 96|ITT-E Population||Participants|||Number
830218|NCT01227824|Secondary|Absolute Values in CD4+ Cell Counts Over Time|CD4 lymphocyte cells (also called T-cells or T-helper cells) are the primary targets of HIV. The CD4 count and the CD4 percentage mark the degree of immunocompromise. The CD4 count is used to stage the patient's disease, determine the risk of opportunistic illnesses, assess prognosis, and guide decisions about when to start antiretroviral therapy.bsolute values in CD4+ cell counts over time was assessed at Baseline, Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, and 96.|Baseline, Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, and 96|ITT-E Population. Only those participants available at the indicated time points were assessed.||cells per millimeters cubed (cells/mm^3)||Standard Deviation|Mean
831572|NCT01247272|Secondary|Cmax of Norfluoxetine.|Informational comparison of Cmax values for the metabolite Norfluoxetine.|Blood samples collected over a 25 day period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
830219|NCT01227824|Secondary|Change From Baseline in Cluster of Differentiation (CD)4+ Cell Counts Over Time|CD4 lymphocyte cells (also called T-cells or T-helper cells) are the primary targets of HIV. The CD4 count and the CD4 percentage mark the degree of immunocompromise. The CD4 count is used to stage the patient's disease, determine the risk of opportunistic illnesses, assess prognosis, and guide decisions about when to start antiretroviral therapy. Changes from Baseline in CD4+ cell counts over time was assessed at Baseline, Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, and 96. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline, Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, and 96|ITT-E Population. Only those participants available at the indicated time points were assessed.||Cells per cubic millimeter (cells/mm^3)||Standard Deviation|Mean
830220|NCT01227824|Secondary|Absolute Values in Plasma HIV-1 RNA Over Time|Absolute values in plasma HIV-1 RNA over time was assessed at Baseline, Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, and 96.|Baseline, Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, and 96|ITT-E Population. Only those participants available at the indicated time points were assessed.||log10 c/mL||Standard Deviation|Mean
830221|NCT01227824|Secondary|Change From Baseline in Plasma HIV-1 RNA Over Time|Change from baseline in plasma HIV-1 RNA over time was assessed at Baseline, Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, and 96. Change from baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline, Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, and 96|ITT-E Population. Only those participants available at the indicated time points were assessed.||log10 c/mL||Standard Deviation|Mean
830222|NCT01227824|Secondary|Number of Participants With Plasma HIV-1 RNA <400 c/mL|The number of participants with plasma HIV-1 RNA level <400 c/mL was assessed at Week 48 and Week 96.|Week 48 and Week 96|ITT-E Population||Participants|||Number
830223|NCT01227824|Secondary|Number of Participants With Plasma HIV-1 RNA <50 c/mL|The number of participants with plasma HIV-1 RNA level <50 c/mL was assessed at Week 96.|Week 96|ITT-E Population||Participants|||Number
830224|NCT01227824|Secondary|Number of Participants With Detectable HIV-1 Virus That Has Genotypic or Phenotypic Evidence of INI Resistance.|Number of participants with detectable virus that has genotypic or phenotypic evidence of Integrase Inhibitor (INI) resistance were assessed at Week 48 and Week 96. Integrase inhibitors are a class of antiretroviral drug designed to block the action of integrase, a viral enzyme that inserts the viral genome into the deoxyribonucleic acid (DNA) of the host cell.|Week 48 and Week 96|ITT-E Population||Participants|||Number
830225|NCT01227824|Primary|Percentage of Participants With HIV-1RNA <50 Copies (c)/Milliliter (mL) Through Week 48.|Percentage of participants with plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) with <50 c/mL was assessed using the Missing, Switch or Discontinuation = Failure (MSDF), as codified by the Food and Drug Administration (FDA) “snapshot” algorithm. The algorithm treats all participants without HIV-1 RNA data as non-responders, as well as participants who switch their concomitant Antiretroviral Therapy (ART) prior to Week 48 as follows: background ART substitutions not permitted per study; background ART substitutions permitted per study unless the decision to switch was documented as being before or at the first on-treatment visit where HIV-1 RNA was assessed. Otherwise, virologic success or failure will be determined by the last available HIV-1 RNA assessment while the subject was on-treatment.|Baseline to Week 48|Intent-to-Treat Exposed (ITT-E) Population: all randomized participants who received at least one dose of study medication||Percentage of participants|||Number
830226|NCT01227889|Secondary|Agreement Rate for V600E Mutation Validation of the BRAF Mutation Assay|Analytical and clinical validation of the companion diagnostic (cDx) assay was performed to determine the extent of agreement between the bioMerieux cDx assay (THxID BRAF Assay) and the Clinical Trial Assay (CTA) to detect BRAF mutations to determine participant eligibility into the study. Skin tissue samples collected at the Screening visit were used for this analysis. Multiple specimen per participant were analyzed.|Screening|V600E positive participants screened for BREAK-3 study||Percent agreement||95% Confidence Interval|Number
830227|NCT01227889|Secondary|Number of Participants With Non-melanoma Skin Lesions: Randomized Phase|Dermatological examinations were performed by the investigator, or at the discretion of the investigator, referred to a dermatologist. The number of participants with non-melanoma skin lessions was assessed from the time of Screening until study completion or discontinuation from the study for any reason.|From Screening until study completion or discontinuation from the study (up to 9.9 months)|Safety Population: all randomized participants who received at least one dose of study drug, based on the actual treatment received, if this differed from that to which the participant was randomized||participants|||Number
830228|NCT01227889|Secondary|Duration of Response as Assessed by the Investigator: Crossover Phase|Duration of response for participants with either a CR (the disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis.) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]) was defined as the time from the first documented evidence of a PR or CR until the first documented sign of PD or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm.|Time from the first documented evidence of PR or CR until the first documented sign of disease progression or death due to any cause (up to 6.4 months)|Crossover Population. Only participants with a confirmed CR or PR were assessed for duration of response.||Months||95% Confidence Interval|Median
830229|NCT01227889|Secondary|Number of Participants With a Best Overall Response of Confirmed Complete Response (CR) or Confirmed Partial Response (PR) as Assessed by the Investigator: Crossover Phase|A participant was defined as a responder if he/she achieved either a CR (the disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis.) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]). Response was evaluated by an investigator per RECIST, version 1.1. A participant without a post-Baseline assessment of response was considered a non-responder. Confirmation, per RECIST version 1.1, requires a confimatory disease assessment of CR or PR at least 28 days after the initial disease assessment of CR or PR.|From randomization until the first documented evidence of a confirmed complete response or partial response (up to 6.4 months)|Crossover Treatment Population. At the time data were analyzed for overall response, only 37 participants had crossed over from DTIC treatment to GSK25118436 treatment.||participants|||Number
830230|NCT01227889|Secondary|Progression-free Survival (PFS2) as Assessed by the Investigator: Crossover Phase|PFS2 is defined as the time from the first dose of GSK2118436, in participants randomized to DTIC who crossed over to GSK2118436 after initial progression, to the earliest date of radiographic or photographic disease progression or death due to any cause. Disease progression was based on radiographic or photographic evidence, and assessments were made by the investigator according to RECIST version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm. For participants who did not progress or die, PFS was censored at the date of last contact.|Time from first dose of GSK2118436 in participants who crossover after initial progression to the earliest date of radiographical or photographical PD or death due to any cause (up to 6.4 months)|Crossover Treatment Population: the subset of participants who were randomized to the DTIC arm, and who elected at the point of disease progression to receive GSK2118436. Only participants who received at least one dose of GSK2118436 were included in the Crossover Treatment Population.||Months||95% Confidence Interval|Median
830231|NCT01227889|Secondary|Duration of Response as Assessed by an Independent Radiologist: Randomized Phase|Duration of response for participants with either a CR (the disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis.) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]) was defined as the time from the first documented evidence of a PR or CR until the first documented sign of PD or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm. NA indicates that data is not available.|Time from the first documented evidence of PR or CR until the first documented sign of disease progression or death due to any cause (up to 7.4 months)|ITT Population. Only participants with a confirmed CR or PR were assessed for duration of response.||Months||95% Confidence Interval|Median
830232|NCT01227889|Secondary|Duration of Response as Assessed by the Investigator: Randomized Phase|Duration of response for participants with either a CR (the disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis.) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]) was defined as the time from the first documented evidence of a PR or CR until the first documented sign of PD or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm.|Time from the first documented evidence of PR or CR until the first documented sign of disease progression or death due to any cause (up to 65.6 weeks)|ITT Population. Only participants with a confirmed CR or PR were assessed for duration of response.||Months||95% Confidence Interval|Median
830233|NCT01227889|Secondary|Number of Participants With a Best Overall Response of Confirmed CR or PR as Assessed by an Independent Radiologist: Randomized Phase|A participant was defined as a responder if he/she achieved either a CR (the disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis.) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]). Response was evaluated by an independent radiologist per RECIST, version 1.1. A participant without a post-Baseline assessment of response was considered a non-responder. Confirmation, per RECIST version 1.1, requires a confimatory disease assessment of CR or PR at least 28 days after the initial disease assessment of CR or PR.|From randomization until the first documented evidence of a confirmed complete response or partial response (median of 12.0 weeks)|ITT Population||participants|||Number
830234|NCT01227889|Secondary|Number of Participants With a Best Overall Response of Confirmed Complete Response (CR) or Confirmed Partial Response (PR) as Assessed by the Investigator: Randomized Phase|A participant was defined as a responder if he/she achieved either a CR (the disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis.) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]). Response was evaluated by an investigator per RECIST, version 1.1. A participant without a post-Baseline assessment of response was considered a non-responder. Confirmation, per RECIST version 1.1, requires a confimatory disease assessment of CR or PR at least 28 days after the initial disease assessment of CR or PR.|From randomization until the first documented evidence of a confirmed complete response or partial response (median of 6.6 weeks)|ITT Population||participants|||Number
830235|NCT01227889|Secondary|Overall Survival|Overall survival is defined as the interval of time between the date of randomization and the date of death due to any cause. For participants who did not die, overall survival was censored at the date of last contact.|Time interval between the date of randomization and the date of death due to any cause (up to 22.1 months)|ITT Population||Months||95% Confidence Interval|Median
830236|NCT01227889|Primary|Progression-free Survival (PFS) as Assessed by an Independent Radiologist: Randomized Phase|PFS is defined as the interval of time between the date of randomization and the earlier of the date of disease progression or the date of death due to any cause. Disease progression was based on radiographic or photographic evidence, and assessments were made by an independent radiologist according to RECIST version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm. For participants who did not progress or die, PFS was censored at the date of last contact.|Time interval between the date of randomization and the earlier of the date of disease progression or the date of death due to any cause (up to 9.9 months)|ITT Population||Months||95% Confidence Interval|Median
839449|NCT01325311|Secondary|Percent of Participants With CYP24 and CYP27B1 SNPs (DNA From Paxgene)||up to Day 35|||percentage of participants|||Number
830237|NCT01227889|Primary|Progression-free Survival (PFS) as Assessed by the Investigator|PFS is defined as the interval of time between the date of randomization and the earlier of the date of disease progression or the date of death due to any cause. Disease progression was based on radiographic or photographic evidence, and assessments were made by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 millimeters (mm). For participants who did not progress or die, PFS was censored at the date of last contact. Data are presented as median and 96% confidence interval.|Time interval between the date of randomization and the earlier of the date of disease progression or the date of death due to any cause (up to 9.9 months)|Intent-to-Treat (ITT) Population: all randomized participants regardless of whether or not treatment was administered||Months||95% Confidence Interval|Median
830238|NCT01227902|Secondary|Change From Baseline in the PGI-C Score: Current Ability to do the Things You Want to do|The PGI-C questionnaire was to be completed by the participant. Participants were asked the following question: Compared to before you started this study, how would you rate your current ability to do the things you want to do: Much better, Moderately better, A little better, Unchanged, A little worse, Moderately worse, Much worse? Rating scores are integers from 1 to 7, with 1=Much better and 7=Much worse.|Baseline through Week 20/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed.||Scores on a scale||Standard Deviation|Mean
830239|NCT01227902|Secondary|Number of Participants With the Indicated Response for the Current Ability to do the Things You Want to do Component of the PGI-C Score|The PGI-C questionnaire was to be completed by the participant. Participants were asked the following question: Compared to before you started this study, how would you rate your current ability to do the things you want to do: Much better, Moderately better, A little better, Unchanged, A little worse, Moderately worse, Much worse.|Baseline through Week 20/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed.||participants|||Number
830240|NCT01227902|Secondary|Change From Baseline in the PGI-C Score: Current Ability to do the Things You Need to do|The PGI-C questionnaire was to be completed by the participant. Participants were asked the following question: Compared to before you started this study, how would you rate your current ability to do the things you need to do: Much better, Moderately better, A little better, Unchanged, A little worse, Moderately worse, Much worse? Rating scores are integers from 1 to 7, with 1=Much better and 7=Much worse.|Baseline through Week 20/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed.||Scores on a scale||Standard Deviation|Mean
830241|NCT01227902|Secondary|Number of Participants With the Indicated Response for the Current Ability to do the Things You Need to do Component of the PGI-C Score|The PGI-C questionnaire was to be completed by the participant. Participants were asked the following question: Compared to before you started this study, how would you rate your current ability to do the things you need to do: Much better, Moderately better, A little better, Unchanged, A little worse, Moderately worse, Much worse?|Baseline through Week 20/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed.||participants|||Number
830242|NCT01227902|Secondary|Change From Baseline in the PGI-C Score: Epilepsy-related Worry|The PGI-C questionnaire was to be completed by the participant. Participants were asked the following question: Compared to before you started this study, how would you rate your current epilepsy-related worry: Much better, Moderately better, A little better, Unchanged, A little worse, Moderately worse, Much worse? Rating scores are integers from 1 to 7, with 1=Much better and 7=Much worse.|Baseline through Week 20/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed.||Scores on a scale||Standard Deviation|Mean
830243|NCT01227902|Secondary|Number of Participants With the Indicated Response for the Epilepsy-related Worry Component of the Patient Global Impression of Change (PGI-C) Score|The PGI-C questionnaire was to be completed by the participant. Participants were asked the following question: Compared to before you started this study, how would you rate your current epilepsy-related worry: Much better, Moderately better, A little better, Unchanged, A little worse, Moderately worse, Much worse?|Baseline through Week 20/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed.||participants|||Number
830244|NCT01227902|Secondary|Change From Baseline in the SF-36v2 Mental Component Summary Score at Week 20/Early Withdrawal|The SF-36 v2 Health Survey is a self-administered, generic, 36-item questionnaire designed to measure 8 domains of functional health status and well-being: physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. Each domain is scored from 0 (poorer health) to 100 (better health).The mental component summary (MCS) score is a summary score representing overall mental health, which is derived from the 8 domains. As with the domains, MCS scores range from 0 to 100; higher scores represent better health. Change from Baseline was calculated as the post-Baseline score minus the Baseline score. Positive changes from Baseline indicate improvement.|Baseline through Week 20/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed.||Scores on a scale||Standard Deviation|Mean
830245|NCT01227902|Secondary|Change From Baseline in the SF-36v2 Physical Component Summary Score at Week 20/Early Withdrawal|The SF-36 v2 Health Survey is a self-administered, generic, 36-item questionnaire designed to measure 8 domains of functional health status and well-being: physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. Each domain is scored from 0 (poorer health) to 100 (better health).The physical component summary (PCS) score is a summary score representing overall physical health, which is derived from the 8 domains. As with the domains, PCS scores range from 0 to 100; higher scores represent better health. Change from Baseline was calculated as the post-Baseline score minus the Baseline score. Positive changes from Baseline indicate improvement.|Baseline through Week 20/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed.||Scores on a scale||Standard Deviation|Mean
830365|NCT01235715|Primary|Units of Homologous Transfusion Over the Course of the Hospital Stay|Units of homologous transfusion for each patient over the course of the hospital stay (an average of 3 days) were recorded.|three days postoperatively|All patients who completed the study were included in analysis.||units||Standard Deviation|Median
830246|NCT01227902|Secondary|Change From Baseline in the Short Form 36 Health Survey, Version 2 (SF-36v2) Domain Scores at Week 20/Early Withdrawal|The SF-36v2 health survey is a self-administered, generic, 36-item questionnaire designed to measure 8 domains of functional health status and well-being: physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. Each domain is scored from 0 (poorer health) to 100 (better health). Change from Baseline was calculated as the post-Baseline score minus the Baseline score. Positive changes from Baseline indicate improvement.|Baseline through Week 20/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed.||Scores on a scale||Standard Deviation|Mean
830247|NCT01227902|Secondary|Percent Change From Baseline in Functional Status: Percentage of Days With no Missed Work or School Time|"Participants were asked the following question daily: Did you miss any time from work or school in the last 24 hours due to epilepsy? Possible responses were Yes, No, and NA=Not Applicable (no planned work or school in the last 24 hours). The variable summarized is the percentage of days with no missed work or school. Baseline and Treatment Phase averages were calculated for each participant. The denominators for these by-phase averages were the number of non-missing days for each variable and phase. The by-phase averages were used as follows in the calculation of percent change from Baseline for each participant: 100 x Treatment Phase average – Baseline Phase average) / Baseline Phase average. A positive percent change from Baseline indicates a reduction from Baseline in missed work or school."|Baseline through Week 20/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed.||Percent change||Standard Deviation|Mean
830248|NCT01227902|Secondary|Functional Status Diary (FSD): Percent Change From Baseline in Epilepsy-related Limitation of Ability to do What You Wanted to|"Participants were asked the following question daily: How would you rate the extent to which epilepsy limited your ability to do what you wanted to do over the last 24 hours? The original possible responses were 0-10, with 0=Not at all limited and 10=Unable to do anything I wanted to. However, in the summarization, 1 was added to each participant's daily response, changing the possible values to 1-11, so that there would be no possibility of the percent change from Baseline being undefined. Baseline and Treatment Phase averages were calculated for each participant. The denominators for these by-phase averages were the number of non-missing days for each variable and phase. The by-phase averages were used as follows in the calculation of percent change from Baseline for each participant: 100 x Treatment Phase average – Baseline Phase average) / Baseline Phase average. A negative percent change from Baseline indicates a reduction from Baseline."|Baseline through Week 20/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed.||Percent change||Standard Deviation|Mean
830249|NCT01227902|Secondary|Functional Status Diary (FSD): Percent Change From Baseline in Epilepsy-related Limitation of Ability to do What You Needed to|"Participants were asked the following question daily: How would you rate the extent to which epilepsy limited your ability to do what you needed to do over the last 24 hours? The original possible responses were 0-10, with 0=Not at all limited and 10=Unable to do anything I needed to. However, in the summarization, 1 was added to each participant's daily response, changing the possible values to 1-11, so that there would be no possibility of the percent change from Baseline being undefined. Baseline and Treatment Phase averages were calculated for each participant. The denominators for these by-phase averages were the number of non-missing days for each variable and phase. The by-phase averages were used as follows in the calculation of percent change from Baseline for each participant: 100 x Treatment Phase average – Baseline Phase average) / Baseline Phase average. A negative percent change from Baseline indicates a reduction from Baseline."|Baseline through Week 20/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed.||Percent change||Standard Deviation|Mean
830250|NCT01227902|Secondary|Functional Status Diary (FSD): Percent Change From Baseline in Epilepsy-related Worry|"Participants were asked the following question daily: How would you rate your epilepsy-related worry over the last 24 hours? The original possible responses were 0-10, with 0=No worry and 10=Worst worry imaginable. However, in the summarization, 1 was added to each participant's daily response, changing the possible values to 1-11, so that there would be no possibility of the percent change from Baseline being undefined. Baseline and Treatment Phase averages were calculated for each participant. The denominators for these by-phase averages were the number of non-missing days for each variable and phase. The by-phase averages were used as follows in the calculation of percent change from Baseline for each participant: 100 x Treatment Phase average – Baseline Phase average) / Baseline Phase average. A negative percent change from Baseline indicates a reduction from Baseline."|Baseline through Week 20/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed.||Percent change||Standard Deviation|Mean
830251|NCT01227902|Secondary|Percent Change From Baseline in Partial-onset Seizure Frequency|Percent change from Baseline was calculated as the difference in the partial-onset seizure frequency (Treatment Phase minus the Baseline Phase) divided by the Baseline Phase frequency, multiplied by 100. Negative values indicate reductions from Baseline. A partial-onset seizure is a seizure that has its onset in a limited area on one side of the brain. Partial-onset seizures may remain limited or may spread to involve both sides of the brain.|From Baseline through Week 20 (Day 140)/Early Withdrawal|ITT Population||percent change||Standard Deviation|Mean
830252|NCT01227902|Secondary|Number of Participants With a >=25%, >=75%, or 100% Reduction in Partial-onset Seizure Frequency From Baseline|The number of participants experiencing a >=25%, >=75%, and 100% reduction from Baseline in partial-onset seizure frequency during the Treatment Phase (TP) (i.e., Titration Phase and Flexible Dose Evaluation [FDE] Phase) was measured. A partial-onset seizure is a seizure that has its onset in a limited area on one side of the brain. Partial-onset seizures may remain limited or may spread to involve both sides of the brain.|From Baseline through Week 20 (Day 140)/Early Withdrawal|ITT Population||participants|||Number
830253|NCT01227902|Secondary|Number of Participants With the Indicated Reduction or Increase From Baseline in Partial-onset Seizure Frequency|Participants were assessed for the percent change from Baseline in seizure frequency; changes were categorized as Any Decrease (>0 to 25%, 25 to <50%, 50 to 75%, >75 to 100%) or No Change or Any Increase (>25%, 0 to 25%). A partial-onset seizure is a seizure that has its onset in a limited area on one side of the brain. Partial-onset seizures may remain limited or may spread to involve both sides of the brain.|From Baseline through Week 20 (Day 140)/Early Withdrawal|ITT Population||participants|||Number
830254|NCT01227902|Primary|Number of Participants With a >=50% Reduction in Partial-onset Seizure (POS) Frequency From Baseline|The number of participants experiencing a >=50% reduction from Baseline (BL) in POS frequency during the Treatment Phase (TP) (i.e., Titration Phase and Flexible Dose Evaluation [FDE] Phase) was measured. A POS has its onset in a limited area on one side of the brain. POSs may remain limited or may spread to involve both sides of the brain. For both the Baseline Phase and the TP, seizure frequency was calculated as a 28-day rate using the following formula: 28 x {[(number of countable partial seizures in Phase) + (10 x number of days with innumerable seizures in Phase) + (number of occurrences of status epilepticus in Phase)] / number of applicable days in the Phase}, where all days in the Phase are considered applicable (including days with 0 seizures), except for days on which the participant failed to complete the Seizure Diary. >= 50% reduction from BL is calculated as 100 x (28-day partial seizure rate [PSR] for the TP - 28-day PSR for the BL Phase) / 28-day PSR for the BL Phase.|From Baseline through Week 20 (Day 140)/Early Withdrawal|Intent-to-Treat (ITT) Population: all participants in the Safety Population (all participants who took at least one dose of investigational product) who provided at least one post-Baseline efficacy assessment||participants|||Number
830255|NCT01227928|Secondary|Number of Participants With the Indicated Worst-case Eastern Cooperative Oncology Group (ECOG) Performance Status Shifts From Baseline Grades of 0, 1, and 2|The ECOG performance status scales and criteria are used by doctors and researchers to assess how a participant's disease is progressing, assess how the disease affects the daily living abilities of the participant, and determine appropriate treatment and prognosis. Grade 0, fully active, able to carry on all pre-disease performance without restriction. Grade 1, restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. Grade 2, ambulatory and capable of all selfcare, but unable to carry out any work activities; up and about more than 50% of waking hours. Grade 3, capable of only limited selfcare; confined to bed or chair more than 50% of waking hours. Grade 4, completely disabled; cannot carry on any selfcare; totally confined to bed or chair. Grade 5, dead.|From Week 1 until the end of the treatment period (up to Study Week 108)|All Treated Population. The cut off for these data was October 12, 2012.||participants|||Number
830256|NCT01227928|Secondary|Number of Participants With the Indicated Worst-case On-therapy Chemistry Parameter Grade Shifts From Baseline Grade|Grade shifts from Baseline were assessed as any grade increase (AGI), increase to Grade (G) 3 (ITG3), and increase to Grade 4 (ITG4). Toxicities were graded according to the National Cancer Institute common toxicity criteria (NCI-Common Toxicity Criteria for Adverse Events), version 4.0. Grade refers to the severity of the toxicity. The CTCAE displays Grades (G) 1 through 5 with unique clinical descriptions of severity for each toxicity based on the following general guideline: G1, mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; G2, moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL); G3, severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL; G4, Life-threatening consequences; urgent intervention indicated.; G5, death related to AE.|From Week 1 until the end of the treatment period (up to Study Week 108)|All Treated Population. Data are presented for only those participants with laboratory values. The cut off for these data was October 12, 2012.||participants|||Number
830257|NCT01227928|Secondary|Number of Participants With the Indicated Worst-case On-therapy Hematology Parameter Grade Shifts From Baseline Grade|Grade shifts from Baseline were assessed as any grade increase (AGI), increase to Grade (G) 3 (ITG3), and increase to Grade 4 (ITG4). Toxicities were graded according to the National Cancer Institute common toxicity criteria (NCI-Common Toxicity Criteria for Adverse Events), version 4.0. Grade refers to the severity of the toxicity. The CTCAE displays Grades (G) 1 through 5 with unique clinical descriptions of severity for each toxicity based on the following general guideline: G1, mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; G2, moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL); G3, severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL; G4, Life-threatening consequences; urgent intervention indicated.; G5, death related to AE.|From Week 1 until the end of the treatment period (up to Study Week 108)|All Treated Population. Data are presented for only those participants with laboratory values. The cut off for these data was October 12, 2012.||participants|||Number
830258|NCT01227928|Secondary|Number of Participants With the Indicated Worst-case On-therapy Shift From Baseline in Bazett's Corrected QT Interval (QTc)|12-lead ECGs were obtained at the scheduled visits. A worst-case on-therapy shift is defined as the worst shift that occurred at any time during the treatment period. The QTc is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. In general, the faster the heart rate the shorter the QTc. If a QTc >=500 milliseconds (msec) was noted on a scheduled or unscheduled electrocardiogram (ECG), then two additional ECGs should have been obtained within 5 minutes to confirm the abnormality. The average QTc was determined from the three ECG tracings by manual evaluation and was used to determine continued eligibility.|From Week 1 until the end of the treatment period (up to Study Week 108)|All Treated Population. Only those participants for which a post-Baseline ECG was conducted were analyzed. The cut off for these data was October 12, 2012.||participants|||Number
830259|NCT01227928|Secondary|Number of Participants With the Indicated Worst-case On-therapy Blood Pressure Shifts From Baseline|Systolic blood pressure (SBP) and Diatolic blood pressure (DBP) are measured in millimeters of mercury (mmHg). A participant could have been counted in more than one shift category. Participants who experienced shifts in both SBP and DBP are represented under each individual parameter. A worst-case on-therapy shift is defined as the worst shift that occurred at any time during the treatment period.|From Week 1 until the end of the treatment period (up to Study Week 108)|All Treated Population. One participant on placebo did not report any blood pressure measurements post-Baseline. The cut off for these data was January 10, 2014.||participants|||Number
830328|NCT01228019|Primary|Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 24|Serum HDL-C levels were measured at start of treatment (baseline) and after 24 weeks of treatment with TREDAPTIVE|Baseline and Week 24|Participants in safety population whose case report form contained baseline and Week 24 data for HDL-C levels and had received TREDAPTIVE for 24 weeks||mg/dL||Standard Deviation|Mean
830260|NCT01227928|Secondary|Number of Participants With Any SAE, Any SAE Related to Study Treatment, and Any Fatal SAE|An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalizaton or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. See the non-serious AE/SAE module for a list of specific events. Relatedness was assessed by the Investigator.|From Week 1 until the end of the treatment period (up to Study Week 108)|All Treated Population: all randomized participants who received at least one dose of investigational product. Treatment assignments in the All Treated Population were based on the actual treatment received, if different from the randomized treatment. The cut off for these data was January 10, 2014.||participants|||Number
830261|NCT01227928|Secondary|Number of Participants With AEs Leading to Permanent Discontinuation of Study Treatment, Dose Interruption, and Dose Reduction|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. Dose interruptions or reductions may have been required following potential drug-related toxicities. As a general rule, if dose reduction of investigational product (IP) was necessary, the dose should have been reduced stepwise by 200 mg at each step, and the participant should have been monitored for 10 to 14 days. If toxicity recurred or worsened during this monitoring time, the IP could have been interrupted and/or the dose of IP further decreased, with continued monitoring for an additional 10 to 14 days, and so on.|From Week 1 until the end of the treatment period (up to Study Week 108)|All Treated Population: all randomized participants who received at least one dose of investigational product. Treatment assignments in the All Treated Population were based on the actual treatment received, if different from the randomized treatment. The cut off for these data was January 10, 2014.||participants|||Number
830262|NCT01227928|Secondary|Number of Participants With the Indicated On-therapy Grade 3-5 AEs|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. On-therapy AEs were those reported from the first day that randomized study drug was received to 28 days after the last dose of randomized study drug, and within 28 days of dose interruption. The NCI-CTCAE Version 3.0 was used to grade AEs per the following scale to assess severity: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling AE; Grade 5, death related to AE. ALT=alanine aminotransferase; AST=aspartate aminotransferase.|From Week 1 until the end of the treatment period (up to Study Week 108)|All Treated Population: all randomized participants who received at least one dose of investigational product. Treatment assignments in the All Treated Population were based on the actual treatment received, if different from the randomized treatment. The cut off for these data was January 10, 2014.||participants|||Number
830263|NCT01227928|Secondary|Number of Participants With Any Grade 3 or 4 AE|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. The NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 3.0 was used to grade AEs per the following scale to assess severity: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling AE; Grade 5, death related to AE.|From Week 1 until the end of the treatment period (up to Study Week 108)|All Treated Population: all randomized participants who received at least one dose of investigational product. Treatment assignments in the All Treated Population were based on the actual treatment received, if different from the randomized treatment. The cut off for these data was January 10, 2014.||participants|||Number
830264|NCT01227928|Secondary|Number of Participants With Any On-therapy AE and Any AE Related to Study Treatment|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. On-therapy AEs were those reported from the first day that randomized study drug was received to 28 days after the last dose of randomized study drug, and within 28 days of dose interruption. Relatedness was assessed by the Investigator.|From Week 1 until the end of the treatment period (up to Study Week 108)|All Treated Population: all randomized participants who received at least one dose of investigational product. Treatment assignments in the All Treated Population were based on the actual treatment received, if different from the randomized treatment. The cut off for these data was January 10, 2014.||participants|||Number
830265|NCT01227928|Secondary|Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalizaton or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. See the non-serious AE/SAE module for a list of specific events.|From Week 1 until the end of the treatment period (up to Study Week 108)|All Treated Population: all randomized participants who received at least one dose of investigational product. Treatment assignments in the All Treated Population were based on the actual treatment received, if different from the randomized treatment. The cut off for these data was January 10, 2014.||participants|||Number
830329|NCT01228019|Primary|Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 24|Serum LDL-C levels were measured at start of treatment (baseline) and after 24 weeks of treatment with TREDAPTIVE|Baseline and Week 24|Participants in safety population whose case report form contained baseline and Week 24 data for LDL-C levels and had received TREDAPTIVE for 24 weeks||mg/dL||Standard Deviation|Mean
830266|NCT01227928|Secondary|Number of Participants With Any Dose Reduction or Any Dose Interruption|Dose interruptions or reductions may have been required following potential drug-related toxicities. As a general rule, if dose reduction of investigational product (IP) was necessary, the dose should have been reduced stepwise by 200 mg at each step, and the participant should have been monitored for 10 to 14 days. If toxicity recurred or worsened during this monitoring time, the IP could have been interrupted and/or the dose of IP further decreased, with continued monitoring for an additional 10 to 14 days, and so on. The cut off for these data was October 12, 2012.|From Week 1 until the end of the treatment period (up to Study Week 108)|All Treated Population: all randomized participants who received at least one dose of investigational product. Treatment assignments in the All Treated Population were based on the actual treatment received, if different from the randomized treatment.||participants|||Number
830267|NCT01227928|Secondary|PFS by Gynaecologic Cancer Intergroup (GCIG) Criteria|"PFS by GCIG criteria is defined as the time from the randomization date to the earliest date of disease progression (PD) per GCIG criteria or death due to any cause. Per GCIG criteria, an objective progression is defined as the earliest event of either tumor progression based on RECIST v1.0 or confirmed CA-125 progression. A participant is counted as Progressed per RECIST if the radiological PD per RECIST occurred prior to or on the same day as CA-125 progression. A participant is counted as Progressed per CA-125 if the radiological PD occurred after CA-125 progression. Per RECIST, PD is defined as at least a 20% increase in the sum of the LD of target lesions, taking as a reference, the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Participants who were alive and had not progressed at the time of analysis were censored at the date associated with the last visit with adequate assessment."|From randomization to the earliest date of disease progression per GCIG criteria or death due to any cause (average of 15.2 months)|ITT Population. The cut off for these data was October 12, 2012.||months||95% Confidence Interval|Median
830268|NCT01227928|Secondary|Overall Survival|Overall survival is defined as the time interval from the date of randomization to the date of death due to any cause.|From randomization until death due to any cause (average of 29.4 months)|ITT Population. Participants who were alive as of study completion were censored at the last contact date. The cut off for these data was January 10, 2014.||months||95% Confidence Interval|Median
830269|NCT01227928|Primary|Progression-free Survival (PFS)|PFS is defined as the time interval between randomization and evidence of progressive disease (PD), as assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, or death, whichever occurred first. A visit-based analysis approach to determine participants’ dates of progression was applied in the analysis method. PD is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as a reference, the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Participants who were alive and had not progressed at the time of analysis were censored at the date associated with the last visit with adequate assessment.|From randomization until evidence of progressive disease or death, whichever occurred first (average of 15.2 months)|Intent-to-Treat (ITT) Population: all randomized participants who were not screen failures. Participants who were screen failures and randomized by mistake, but who did not receive study treatment, were not included. The treatment assignment in the ITT Population was based on the randomized treatment. The data cut off was October 12, 2012.||months||95% Confidence Interval|Median
830270|NCT01227954|Secondary|ApoE4 Genotype and Other Potentially Predictive Biomarkers of Cognitive Function|Per the protocol, the feasibility of the proposed translational studies were to be assessed following completion of accrual and sample collection. The decision was made not to pursue this outcome measure. No assays were performed and no data were collected for this Outcome Measure|Baseline and 4 months from start of treatment||||||
830271|NCT01227954|Secondary|The Frequency of Patients With Grade 3 and Higher Adverse Events (AE) Related to Treatment|For each patient the highest grade adverse event related to treatment was calculated. Those with their highest grade of 3 or higher were counted. Adverse events are graded using CTCAE v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE|From start of treatment to 12 months from start of treatment|Eligible patients who started study treatment||Participants|||Count of Participants
830272|NCT01227954|Secondary|Progression-free Survival|Progression (radiographic) is defined as an increase in perpendicular bidimensional tumor area (at lease 50% for lesions < 1cm, at least 25% for lesions >=1cm) for any of the 1-3 tracked brain metastases, or the appearance of any new brain metastasis on a follow-up MRI. Progression-free survival was calculated instead of time to progression. Progression-free survival time was measured from registration to the date of progression, death, or last known follow-up (censored). The Kaplan-Meier method used to determine median time (along with 95% confidence intervals).|Analysis occurs after all patients have been on study for at least 4 months. (Patients are followed from registration to death or study termination whichever occurs first.)|Eligible patients who started study treatment||months||95% Confidence Interval|Median
830273|NCT01227954|Secondary|Overall Survival|Overall survival was measured from registration to the date of death or last known follow-up (censored). Kaplan-Meier estimator was used to median survival time and 95% confidence interval.|Analysis occurs after all patients have been on study for at least 4 months. (Patients are followed from registration to death or study termination whichever occurs first.)|Eligible patients who started study treatment||months||95% Confidence Interval|Median
830274|NCT01227954|Secondary|Quality of Life as Measured by the Barthel Index of Activities of Daily Living (ADL)|The Barthel Index of Activities of Daily Living (ADL) is a 10-item assessment. Patient scores on the ADL range from 0 to 20 with lower scores indicating declining functional status.|Baseline and 4 months from start of treatment|Eligible patients who started treatment and completed at least one ADL assessment||units on a scale||Full Range|Median
830286|NCT01227967|Secondary|Time to Feeling as Good as Before the Onset of the Influenza Illness|Time to feeling as good as before influenza is defined as time to the first of two successive 'yes' responses to the question of 'feeling as good as you did before you had the flu'.For participants who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with question answered.|From treatment initiation to Day 28|The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug.||Days||95% Confidence Interval|Median
830275|NCT01227954|Secondary|Quality of Life as Measured by the Functional Assessment of Cancer Therapy-Brain (FACT-Br)|The FACT-Br is a 19-item self-report instrument designed to measure multidimensional quality of life in patients with brain cancer. It is to be administered with the FACT-General. The FACT-G is a validated, 27-item measure where a higher score represents higher QOL. In addition to a total QOL score, subscale scores for physical, functional, social and emotional well-being are produced. There are 5 responses options, 0=Not a lot to 4=Very much. All subscale items are added together, multiplied by the number of items in the subscale, then divided by the number of items answered to obtain subscale totals. Scores range 0-108 for FACT-G total, 0-28 for physical, social, functional subscales, 0-24 for emotional subscale, 0-76 for brain subscale. Certain items must be reversed before it is added by subtracting the response from 4. Subscale requires >= 50% of items to be completed while the overall response rate must be > 80%. If items are missing, the subscale scores can be prorated.|Baseline and 4 months from start of treatment|Eligible patients who started treatment and completed at least one FACT-Br assessment||units on a scale||Full Range|Median
830276|NCT01227954|Secondary|Percent Change at 4 Months in Visual Learning Measured by Cogstate's One Card Learning Test (OCLT)|The score is the arcsine of the square root of the proportion of correct responses. A higher score indicates a better performance. Each patient served as her or his own control, and the percent change in OCLT score from baseline to 4 months was calculated as 100*[(baseline score - 4 month score)/ baseline score].|Baseline and 4 months from start of treatment|Eligible patients who started treatment and had baseline and 4 month data||percent change||95% Confidence Interval|Mean
830277|NCT01227954|Secondary|Percent Change at 4 Months in Auditory Learning Measured by Cogstate's International Shopping List Test (ISLT)|The score is the total number of correct responses made in remembering the list on three consecutive trials in a single session. A higher score indicates a better performance. Each patient served as her or his own control, and the percent change in ISLT score from baseline to 4 months was calculated as 100*[(baseline score - 4 month score)/ baseline score].|Baseline and 4 months from start of treatment|Eligible patients who started treatment and had baseline and 4 month data||percent change||95% Confidence Interval|Mean
830278|NCT01227954|Primary|Percent Change in Delayed Recall at 4 Months as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R)|Change in Hopkins Verbal Learning Test-Revised delayed recall (HVLT_R DR) score from baseline to 4 months after the start of treatment calculated as (baseline score - 4 month score)/ baseline score. A positive change indicates a decline in function. The HVLT-R assesses verbal learning and memory. It incorporates 6 different forms, helping to mitigate practice effects of repeated administrations. Each form includes 12 nouns (targets) with 4 words drawn from 3 semantic categories, which differ across the 6 forms. Delayed recall involves recalling a list of 12 targets after a 20-minute delay. The score is the sum of the number of targets correctly recalled. Percent change calculated as 100*[(baseline score - 4 month score)/ baseline score]|Baseline and 4 months from start of treatment|Eligible patients who started treatment and had baseline and 4 month data||percent change||95% Confidence Interval|Mean
830279|NCT01227967|Secondary|28-day Mortality|Number of deaths|From treatment initiation to Day 28|The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug.||participants|||Number
830280|NCT01227967|Secondary|Percentage of Participants Who Required Hospitalization.|The percentage of participants hospitalized by 28 days was estimated from the Kaplan-Meier curves.|From treatment initiation to Day 28|The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug.||percentage of participants analyzed||95% Confidence Interval|Number
830281|NCT01227967|Secondary|Percentage of Participants Who Required New or Increased Use of Supplemental Oxygen|Percentage of participants who required new or increased use of supplemental oxygen|From treatment initiation to Day 28|The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug.||percentage of participants analyzed|||Number
830282|NCT01227967|Secondary|Percentage of Participants Who Develop Bronchitis, Pneumonia, or Other Complications of Influenza After Day 0.|Participants were assessed for the signs/symptoms suggestive of one of the following complications: Sinusitis, Otitis Media ,Bronchitis / Bronchiolitis, Pneumonia and antibiotic use for reason other than above.|From treatment initiation to Day 28|The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug. The categories in the table are not mutually exclusive (because some participants had multiple complications) and the last row of the table summarizes all incidents.||percentage of participants analyzed|||Number
830283|NCT01227967|Secondary|Percentage of Participants With Clinical Failure at Day 5|Clinical failure at Day 5 is defined as the need for continued (non-study) antiviral use after Day 5.|From treatment initiation to Day 28|The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug.||percentage of participants analyzed|||Number
830284|NCT01227967|Secondary|Time to Return of Physical Function to Pre-illness Leve|Time to return of physical function to pre-illness level was defined as the time from Day 0 to the first of two successive measurements at which the physical function score equals or is better than the pre-illness score (obtained by recall at enrollment).For subjects who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with physical function evaluated.|From treatment initiation to Day 28|The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug.||Days||95% Confidence Interval|Median
830285|NCT01227967|Secondary|Time to Return to Pre-influenza Function|Time to return to pre-influenza function is defined as the time from Day 0 to the first of two successive 'Yes' answers to the global assessment question 'Are you functioning as well as you were before you had the flu'.For participants who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with question answered.|From treatment initiation to Day 28|The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug.||Days||95% Confidence Interval|Median
830287|NCT01227967|Secondary|Time to Resolution of All Symptoms AND Fever|The assessed symptoms were cough, nasal obstruction (stuffy nose), sore throat, fatigue, headache, muscle aches, feverishness, rhinorrhea, nausea, vomiting, diarrhea. Fever was considered present based on the diary cards if a subject reported a maximal temperature ≥38.0°C (for the period since the diary card was previously completed) or reported having taken an antipyretic drug (also for the period since the diary card was previously completed). Time to resolution of all clinical symptoms and fever is defined as the time from Day 0 to the first of two successive measurements at which all clinical symptoms are grade 0 (absent) or 1(mild) and no fever >=38.0 C or antipyretic drug is reported. For participants who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with symptoms and fever evaluated.|From treatment initiation to Day 28|The population analyzed is the Intention To Treat (ITT) Population, which includes all participants who were randomized properly and who had received at least one dose of study drug.||Days||95% Confidence Interval|Median
830288|NCT01227967|Secondary|Time to Absence of Fever|Fever was considered present based on the diary cards if a subject reported a maximal temperature ≥38.0°C (for the period since the diary card was previously completed) or reported having taken an antipyretic drug (also for the period since the diary card was previously completed). Otherwise, fever was considered not present during the period since the diary card was previously completed, except that the evaluation was considered missing if either the temperature or the antipyretic drug use entry was not completed on the diary card. The duration of fever was defined as the time from Day 0 to the first of two successive assessments (through to Day 7) or to the first assessment (Day 8 onwards) at which no fever was present according to this definition.For participants who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with fever evaluated.|From treatment initiation to Day 28|The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug.||Days||95% Confidence Interval|Median
830289|NCT01227967|Secondary|Time to Alleviation of Influenza Clinical Symptoms.|The assessed symptoms were cough, nasal obstruction (stuffy nose), sore throat, fatigue, headache, muscle aches, feverishness, rhinorrhea, nausea, vomiting, diarrhea. Duration of clinical symptoms is defined as the time from Day 0 to the first of two successive measurements at which all clinical symptoms are grade 0 (absent) or 1 (mild). A measurement is considered to be the 8AM or 8PM assessment during Days 0 to 7 (so two measurements are obtained per day) and then the daily assessment thereafter. Time will then be calculated in half-days through to Day 7. If a subject’s first two assessments on (baseline assessment and first subsequent diary card assessment) satisfy this criterion, then the duration will be set to zero. For participants who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with symptoms evaluated.|From treatment initiation to Day 28|The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug.||Days||95% Confidence Interval|Median
830290|NCT01227967|Secondary|Number of Participants Shedding Virus|Number of participants with undetectable viral load at both Day 3 and Day 7; detectable at Day 3 and undetectable at Day 7; detectable at Day 7 (irrespective of whether or not detectable at Day 3).|At day 3 and 7.|The population analyzed is the Primary Efficacy Population (PEP), which included all participants who were randomized properly, had received at least one dose of study drug, and had influenza virus isolated and typed in the qualitative PCR evaluation at Day 0 from central laboratory testing.||Participants|||Count of Participants
830291|NCT01227967|Secondary|qPCR Viral Shedding|Median, 25% and 75% percentile of the value of viral shedding (Results <LOD were imputed as the LOD value, and Results >= LOD, <LLOQ were imputed as the LLOQ value.)|At Day 0, 3 and 7|The population analyzed is the Primary Efficacy Population (PEP), which included all participants who were randomized properly, had received at least one dose of study drug, and had influenza virus isolated and typed in the qualitative PCR evaluation at Day 0 from central laboratory testing.||Log10 copies/mL||Inter-Quartile Range|Median
830292|NCT01227967|Secondary|Number of Participants by Virus Detection Status|Number of participants who had undetectable values (less than the limit of detection [LOD]), who had values between the LOD and the lower limit of quantification (LLOQ), and who had values ≥LLOQ|At Day 0, 3 and 7.|The population analyzed is the Primary Efficacy Population (PEP), which included all participants who were randomized properly, had received at least one dose of study drug, and had influenza virus isolated and typed in the qualitative PCR evaluation at Day 0 from central laboratory testing.||Participants|||Count of Participants
830293|NCT01227967|Primary|Percentage of Participants With Virus Detectable by Quantitative PCR (qPCR) in Nasopharyngeal (NP) Swabs|The central laboratory performed a qualitative PCR test on the NP sample from Day 0 in order to confirm influenza infection and to determine the influenza type and subtype. For participants with a positive influenza test result at Day 0 from this qualitative PCR testing, the laboratory then performed qPCR testing of subsequent samples to quantify viral shedding.|At Day 3|The population analyzed was restricted to the 407 participants who had a confirmed positive test for influenza by qPCR in the central laboratory testing and were not in the pilot study for IRC003. 13 participants (5 in the Combination Therapy and 8 in the Oseltamivir Monotherapy) had missing endpoint samples so were excluded from the analysis.||percentage of participants analyzed|||Number
830294|NCT01227980|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|90 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||Units on a scale||Standard Error|Mean
830295|NCT01227980|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|75 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||units on a scale||Standard Error|Mean
830296|NCT01227980|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|60 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||units on a scale||Standard Error|Mean
830297|NCT01227980|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|45 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||units on a scale||Standard Error|Mean
830298|NCT01227980|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|30 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||units on a scale||Standard Error|Mean
830299|NCT01227980|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||units on a scale||Standard Error|Mean
830300|NCT01227980|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|5 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||units on a scale||Standard Error|Mean
830301|NCT01227980|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes prior to the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||units on a scale||Standard Error|Mean
830302|NCT01227980|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|90 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||units on a scale||Standard Error|Mean
830303|NCT01227980|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|75 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||units on a scale||Standard Error|Mean
830304|NCT01227980|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|60 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||units on a scale||Standard Error|Mean
830305|NCT01227980|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|45 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||units on a scale||Standard Error|Mean
830306|NCT01227980|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|30 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||units on a scale||Standard Error|Mean
830307|NCT01227980|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||Units on a scale||Standard Error|Mean
830308|NCT01227980|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|5 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||units on a scale||Standard Error|Mean
830309|NCT01227980|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes prior to the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||Units on a scale||Standard Error|Mean
830310|NCT01227993|Secondary|Change in Autofluorescence Patterns in the Fellow Eye as Observed on Fundus Autofluorescence (FAF) Imaging at Two Years Compared to Baseline||Baseline and 2 years||||||
830311|NCT01227993|Secondary|Change in Autofluorescence Patterns in the Study Eye as Observed on Fundus Autofluorescence (FAF) Imaging at Two Years Compared to Baseline||Baseline and 2 years||||||
830312|NCT01227993|Secondary|Change in Plaque Size in the Fellow Eye as Observed on Indocyanine Green (ICG) Imaging at Two Years Compared to Baseline||Baseline and 2 years||||||
830313|NCT01227993|Secondary|Change in Plaque Size in the Study Eye as Observed on Indocyanine Green (ICG) Imaging at Two Years Compared to Baseline||Baseline and 2 years||||||
830314|NCT01227993|Secondary|Change in Area of Leakage in the Fellow Eye as Observed on Fluorescein Angiography (FA) Imaging at Two Years Compared to Baseline||Baseline and 2 years||||||
830315|NCT01227993|Secondary|Change in Area of Leakage in the Study Eye as Observed on Fluorescein Angiography (FA) Imaging at Two Years Compared to Baseline||Baseline and 2 years||||||
830316|NCT01227993|Secondary|Change in Subretinal Fluid in the Fellow Eye as Assessed by Optical Coherence Tomography (OCT) at Two Years Compared to Baseline||Baseline and 2 years||||||
830317|NCT01227993|Secondary|Change in Subretinal Fluid in the Study Eye as Assessed by Optical Coherence Tomography (OCT) at Two Years Compared to Baseline||Baseline and 2 years||||||
830318|NCT01227993|Secondary|Change in 24-hour Urine Cortisol Levels at Two Years Compared to Baseline|The amount of cortisol found in urine was assessed from each participant at baseline and at two years. The mean change from baseline to two years is reported here in micrograms.|Baseline and 2 years|||µg||Standard Deviation|Mean
830319|NCT01227993|Secondary|Change in Serum DHT Levels at Two Years Compared to Baseline|The concentration of dihydrotestosterone (DHT) in blood serum was assessed from each participant at baseline and at two years. The mean change from baseline to two years is reported here in picograms of DHT per milliliter of serum.|Baseline and 2 years|||pg/mL||Standard Deviation|Mean
830320|NCT01227993|Secondary|Change in Serum Testosterone Levels at Two Years Compared to Baseline|The concentration of testosterone in blood serum was assessed from each participant at baseline and at two years. The mean change from baseline to two years is reported here in nanograms of testosterone per decaliter of serum.|Baseline and 2 years|||ng/dL||Standard Deviation|Mean
830321|NCT01227993|Secondary|Change in Best-corrected Visual Acuity (BCVA) in the Fellow Eye at One Year Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 1 year|||ETDRS letters|Participants|Standard Deviation|Mean
830322|NCT01227993|Secondary|Change in Best-corrected Visual Acuity (BCVA) in the Study Eye at One Year Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 1 year|||ETDRS letters|Participants|Standard Deviation|Mean
830323|NCT01227993|Secondary|Change in Best-corrected Visual Acuity (BCVA) in the Fellow Eye at Two Years Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 2 years|||ETDRS letters|Participants|Standard Deviation|Mean
830324|NCT01227993|Primary|Change in Best-corrected Visual Acuity (BCVA) in the Study Eye at Two Years Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 2 years|||ETDRS letters|Participants|Standard Deviation|Mean
830325|NCT01228019|Primary|Investigator's Overall Efficacy Evaluation at Week 24|The investigator evaluated all available data after 24 weeks of TREDAPTIVE and assigned an overall evaluation of “Improved”, “Unchanged” or “Worsened” when compared to baseline.|Baseline and Week 24|Participants in safety population whose case report form contained the investigator's overall assessment after 24 weeks of treatment with TREDAPTIVE||Percentage of Participants|||Number
830326|NCT01228019|Primary|Investigator's Overall Efficacy Evaluation at Week 12|The investigator evaluated all available data after 12 weeks of TREDAPTIVE and assigned an overall evaluation of “Improved”, “Unchanged” or “Worsened” when compared to baseline.|Baseline and Week 12|Participants in safety population whose case report form contained the investigator's overall assessment after 12 weeks of treatment with TREDAPTIVE||Percentage of Participants|||Number
830327|NCT01228019|Primary|Change From Baseline in Triglycerides at Week 24|Serum triglyceride levels were measured at start of treatment (baseline) and after 24 weeks of treatment with TREDAPTIVE|Baseline and Week 24|Participants in safety population whose case report form contained baseline and Week 24 data for triglyceride levels and had received TREDAPTIVE for 24 weeks||mg/dL||Standard Deviation|Mean
830330|NCT01228019|Primary|Change From Baseline in Total Cholesterol at Week 24|Serum cholesterol levels were measured at start of treatment (baseline) and after 24 weeks of treatment with TREDAPTIVE|Baseline and Week 24|Participants in safety population whose case report form contained baseline and Week 24 data for total cholesterol levels and had received TREDAPTIVE for 24 weeks||mg/dL||Standard Deviation|Mean
830331|NCT01228019|Primary|Change From Baseline in Triglycerides at Week 12|Serum triglyceride levels were measured at start of treatment (baseline) and after 12 weeks of treatment with TREDAPTIVE|Baseline and Week 12|Participants in safety population whose case report form contained baseline and Week 12 data for triglyceride levels.||mg/dL||Standard Deviation|Mean
830332|NCT01228019|Primary|Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12|Serum HDL-C levels were measured at start of treatment (baseline) and after 12 weeks of treatment with TREDAPTIVE|Baseline and Week 12|Participants in safety population whose case report form contained baseline and Week 12 data for HDL-C levels.||mg/dL||Standard Deviation|Mean
830333|NCT01228019|Primary|Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12|Serum LDL-C levels were measured at start of treatment (baseline) and after 12 weeks of treatment with TREDAPTIVE|Baseline and Week 12|Participants in safety population whose case report form contained baseline and Week 12 data for LDL-C levels.||mg/dL||Standard Deviation|Mean
830334|NCT01228019|Primary|Change From Baseline in Total Cholesterol at Week 12|Serum cholesterol levels were measured at start of treatment (baseline) and after 12 weeks of treatment with TREDAPTIVE|Baseline and Week 12|Participants in safety population whose case report form contained baseline and Week 12 data for total cholesterol levels.||mg/dL||Standard Deviation|Mean
830335|NCT01228019|Primary|Percentage of Participants With Adverse Drug Reactions|An adverse drug reaction was an adverse event of which the relationship to the study drug could not be ruled out. An adverse event was any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the study drug, was also an adverse event.|From start of treatment through 14 days after the last dose (Up to 26 weeks)|Safety population: all enrolled participants who met entry criteria regarding safety data||Percentage of Participants|||Number
830336|NCT01228019|Primary|Percentage of Participants With Any Adverse Experience|An adverse event was any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the study drug, was also an adverse event.|From start of treatment through 14 days after the last dose (Up to 26 weeks)|Safety population: all enrolled participants who met entry criteria regarding safety data||Percentage of participants|||Number
830337|NCT01228071|Primary|Gel Drying Time|Testosterone gel 2% drying time was assessed with a stopwatch. On Day 14 at the time of application of the gel directly to the first anteromedial thigh, the subject started a stopwatch. The gel was spread as evenly as possible over an area of 1 g/100 cm2. The total coverage area on the thigh was approximately equal to two (2) 3”× 5” postcards. The subject gently rubbed the gel with his fingertip in a circular motion (avoiding contact with the scrotal region) until the gel was dry. At this time, the stopwatch was stopped and the time expended was recorded in the eCRF.|1 day; drying time measured following gel application on Day 14|The PK population consisted of all subjects who had a drug drying time, required trough concentrations values, and no protocol violations significantly affecting the PK data.||minutes||95% Confidence Interval|Median
830338|NCT01228071|Primary|Time to Steady State (SS)|Trough total testosterone levels were obtained at Day 2, Day 3, Day 4, Day 7, and Day 14 to assess time to steady state. Trough concentrations over the 14-day period were used to calculate time SS.|14 days|The PK population consisted of all subjects who had a drug drying time, required trough concentrations values, and no protocol violations significantly affecting the PK data.||days||95% Confidence Interval|Median
830339|NCT01228071|Primary|Time to Target Eugonadal Range|The time to eugonadal range (ie, testosterone ≥300 ng/dL) was assessed based on the 24-hour PK serum concentration data.|24 hours|Of the 31 subjects in the PK population, 7 subjects were not included in the analysis for time to eugonadal range. Five (5) subjects had total testosterone serum concentrations of ≥300 ng/dL at Visit 2 (baseline, time 0) and 2 subjects had total testosterone serum concentrations that never reached 300 ng/dL.||hours||95% Confidence Interval|Median
830340|NCT01228084|Secondary|Half-life of SFN in Blood Among Patients With Glutathione-S-Transferase Mu 1 (GSTM1) Intact Genotype||Day 1 of study treatment|||hours||Full Range|Median
830341|NCT01228084|Secondary|Half-life of SFN in Blood Among Patients With Glutathione-S-Transferase Mu 1 (GSTM1) Null Genotype||Day 1 of study treatment|||Hours||Full Range|Median
830342|NCT01228084|Secondary|Half-life of Sulforaphane (SFN) in Blood||Day 1 of study treatment|||hours||Full Range|Median
830343|NCT01228084|Secondary|Incidence of Grade 3 or Higher Treatment Related Toxicity|Toxicities will be graded based on the NIH Cancer Therapy Evaluation Program (CTEP) Common Toxicity Criteria of Adverse Events Version 4.0 (http://ctep.cancer.gov). All adverse events of any grade (for example, abnormal laboratory values, etc.) deemed clinically significant by the investigator will be recorded as a measure of the safety profile of sulforaphane|Continually through study and 14-30 days after last drug dose.|||participants|||Number
830344|NCT01228084|Secondary|Proportion of Patients Whose PSA Levels Have Not Doubled||While on treatment with sulforaphane (less than or equal to 20 weeks.)|||percentage of participants|||Number
830345|NCT01228084|Secondary|Minimum Percent Change in PSA (i.e., the Smallest Increase for Those With Increased PSA and the Greatest Decline for Those With Decreased PSA)||PSA measured every 28 days while on study treatment, an average of 5 months|||percent change||Full Range|Median
830346|NCT01228084|Secondary|Percent Change in PSA From Baseline to Final Measured Value at End of Study|To determine the percentage change in PSA from baseline to the final measured value at the end of study.|Measure at baseline and after stopping study treatment (less than or equal to 20 weeks of treatment with sulforaphane.)|||Percent change||Full Range|Median
830364|NCT01235715|Secondary|Range of Motion at 6 Weeks|A measurement of the degrees of motion of the operated knee six weeks after surgery.|6 weeks postoperatively|Patients whose range of motion at 6-week followup appointment was taken were included in analysis.||degrees||Standard Deviation|Mean
830347|NCT01228084|Primary|Proportion of Patients Who Achieve a 50% Decline in Prostate-Specific Antigen (PSA) Levels|To determine the proportion of patients who achieve a decline in PSA levels while receiving sulforaphane treatment. as a measure of anti-tumor activity in men with recurrent prostate cancer.|Less than or equal to 20 weeks of sulforaphane treatment.|||percentage of participants|||Number
830348|NCT01228149|Secondary|Number of Suture Lyses|Number of suture lyses at visit 5 (week 12 after surgery)|week 12|Intention-to- treat population||Participants|||Count of Participants
830349|NCT01228149|Secondary|Change in Conjunctival Redness|"Conjunctival redness (ORA Scale) evaluated from 16 up to 28 days (time window) prior surgery and 1 day prior surgery. The investigator compares patient's study eye with a set of reference photos showing various degrees of redness. Redness was scored on a scale of none, mild, moderate, severe and very severe. Absolute and relative frequencies of visit 1 and 2 were compared descriptively."|24 weeks|ITT population||Participants|||Count of Participants
830350|NCT01228149|Secondary|Change in Quality of Life|"Change in quality of life measure by a certified National Eye Institute Visual Functioning Questionnaire containing 25 questions (NEI VFQ-25).Patients tick a score at every question to present their visual functioning (usually from 1-5 or 1-6 in which 1 is best and 6 worse). Every single item/score is transformed to a scale between 0 and 100 (0 best, 100 worse). For the total score, the mean of all transformed scores/items is calculated.
NEI VFQ 25 Quality of Life Questionnaire composite score at V5 (week 12 after surgery).
Outcome shows mean of differences and 95% confidence intervall."|12 weeks|ITT Population||scores on a scale||Standard Deviation|Mean
830351|NCT01228149|Secondary|Filtration Bleb Classification|"Filtration bleb classification (Grehn) in both Groups 1 week, 4 weeks, 12 weeks and 24 week after surgery.
For classification the following criteria were evaluated and scored as described below:
vascularisation (0=None, 1=mild, 2=a few corkscrew vessels)
identifiability (0=no borders to sides; 1=demarcation nasally or temporally; 2= demarcation to both sides; 3= encapsulated)
Thickness (0= a least 3mm; 1=2mm; 2= 1mm; 3=flat)
Microcysts (0=no; 1= yes)
Transparency (0= highly transparent; 2=moderate; 2=not transparent)
Mobility (0= yes; 1= no)
Leakage (0=yes, 1=no)
For the change in the filtration bleb classification (only thickness at visit 5/week 12 mentioned below) descriptive statistics were presented only."|24 weeks|PP Population||Participants|||Count of Participants
830352|NCT01228149|Secondary|Change in IOP Between Visit 1 and 2|Change in IOP between Visit 1 (Screening visit 16 to 28 day prior trabeculectomy) and Visit 2 (1 day before trabeculectomy). Outcome shows mean of differences and 95% confidence intervall.|28 days|PP Population||mmHg||95% Confidence Interval|Mean
830353|NCT01228149|Secondary|Ocular Hypotension Rate|Ocular hypotension rate (0-5 mmHg of the study eye) indicated by the number of patients with ocular hypertension|24 weeks|PP Population||Participants|||Count of Participants
830354|NCT01228149|Secondary|Number of Necessary 5-Fluorouracil (5FU) Injections|Number of post-operative necessary 5-Fluorouracil (5FU) injections at week 12|12 weeks|PP Population (n=58)||number of injections||Standard Deviation|Mean
830355|NCT01228149|Secondary|Number of Needling|number of patients requirering needling|12 weeks|Patients of the PP population||Participants|||Count of Participants
830356|NCT01228149|Primary|Change in Intraocular Pressure (IOP) (ΔIOP) Three Months After Trabeculectomy in Comparison to the Mean Preoperative IOP|Change in IOP (ΔIOP) three months after trabeculectomy in comparison to the mean preoperative IOP at one day prior surgery|12 weeks|In total 62 patients were randomized, 30 to COSOPT-S®, 32 to DIAMOX+Dexa edo® (intention-to-treat (ITT) population. Per-protocol (PP) population (treated >8 days and did not take any medication that interfered with the study): n=58 patients: 27 p. in COSOPT-S®, 31 p. in DIAMOX+Dexa edo®. Analysis population: patients who completed the study n=53||mmHg||95% Confidence Interval|Mean
830357|NCT01228175|Primary|Cigarettes Per Smoking Day||up to 36 weeks|||Cigarettes smoked||Standard Deviation|Mean
830358|NCT01228435|Secondary|Safety|Further document the safety of this regimen. Treatment-emergent adverse events will be summarized by MedDEA coding terms and seperate tabulations will be produced for treatment-related adverse events, treatment-emergent serious adverse events, discontinuations due to adverse events, and treatment-emergent events of at least Grade 3 severity.|2 years||||||
830359|NCT01228435|Primary|Response Rate|The response rate was defined as the number of patients achieving a RECIST 1.0 defined response divided by the number of patients treated and was to be calculated seperately for each arm. A response by RECIST criteria means that the pre-defined target lesions (sum of the longest diameters) had to decrease by 30% or more and this response needed to be confirmed on a second scan at least 4 weeks later.|2 years|||participants|||Number
830360|NCT01235715|Secondary|Visual Analog Pain Scale (At Night) At 6 Weeks|The visual analog pain scale is a patient-reported measure of pain on a 10-point scale with 0 being no pain and 10 being worst possible pain. Drawings of faces indicate the level of pain associated with different points on the scale. For the measure of pain at night, the patient indicates their level of pain during or before sleep.|6 weeks postoperatively|||units on a scale||Standard Deviation|Mean
830361|NCT01235715|Secondary|Visual Analog Pain Scale (During Therapy) at 6 Weeks|The visual analog pain scale is a patient-reported measure of pain on a 10-point scale with 0 being no pain and 10 being worst possible pain. Drawings of faces indicate the level of pain associated with different points on the scale. For the measure of pain during, the patient indicates their level of pain during physical therapy.|6 weeks postoperatively|||units on a scale||Standard Deviation|Mean
830362|NCT01235715|Secondary|Visual Analog Pain Scale (During Activity) at 6 Weeks|The visual analog pain scale is a patient-reported measure of pain on a 10-point scale with 0 being no pain and 10 being worst possible pain. Drawings of faces indicate the level of pain associated with different points on the scale. For the measure of pain during, the patient indicates their level of pain while doing activities of daily living such as walking and moving from sitting to standing.|6 weeks postoperatively|Patients whose visual analog pain scale at 6-week followup appointment was taken were included in analysis.||units on a scale||Standard Deviation|Mean
830363|NCT01235715|Secondary|Visual Analog Pain Scale (at Rest) at 6 Weeks|The visual analog pain scale is a patient-reported measure of pain on a 10-point scale with 0 being no pain and 10 being worst possible pain. Drawings of faces indicate the level of pain associated with different points on the scale. For the measure of pain at rest, the patient indicates their level of pain while seated or lying down, not moving.|6 weeks postoperatively|Patients whose visual analog pain scale at 6-week followup appointment was taken were included in analysis.||units on a scale||Standard Deviation|Mean
830367|NCT01235715|Primary|Drain Output|A measurement of the amount of blood drained from the knee.|24 hours post-operatively|All patients enrolled in study were subject to analysis; occasionally a patient's levels were not taken or were not available for analysis for various reasons||mL||Standard Error|Mean
830368|NCT01235715|Primary|Change in Hematocrit on Day 2 Compared to Preoperatively||preoperatively and two days after surgery|All patients enrolled in study were subject to analysis; occasionally a patient's levels were not taken or were not available for analysis for various reasons.||percentage of red blood cell||Standard Deviation|Mean
830369|NCT01235715|Primary|Change in Hemoglobin on Day 2 Compared to Preoperatively||preoperatively and two days after surgery|All patients enrolled in study were subject to analysis; occasionally a patient's levels were not taken or were not available for analysis for various reasons.||g/dL||Standard Deviation|Mean
830370|NCT01235715|Primary|Change in Hematocrit on Day 1 Compared to Preoperatively||preoperatively and one day after surgery|All patients enrolled in study were subject to analysis; occasionally a patient's levels were not taken or were not available for analysis for various reasons.||percentage of red blood cell||Standard Deviation|Mean
830371|NCT01235715|Primary|Change in Hemoglobin On Day 1 Compared to Preoperatively||preoperatively and one day after surgery|All patients enrolled in study were subject to analysis; occasionally a patient's levels were not taken or were not available for analysis for various reasons.||g/dL||Standard Deviation|Mean
830372|NCT01235715|Primary|Change in Hematocrit on Day 0 Compared to Preoperatively||preoperatively and day of surgery|All patients enrolled in study were subject to analysis; occasionally a patient's levels were not taken or were not available for analysis for various reasons.||percentage of red blood cell||Standard Error|Mean
830373|NCT01235715|Secondary|Visual Analog Pain Scale on Day 3|The visual analog pain scale is a patient-reported measure of pain on a 10-point scale with 0 being no pain and 10 being worst possible pain. Drawings of faces indicate the level of pain associated with different points on the scale.|3 days postoperatively|||points on VAS scale||Standard Error|Mean
830374|NCT01235715|Secondary|Range of Motion on Day 3|A measurement of the degrees of motion of the operated knee three days after surgery.|3 days postoperatively|||degrees||Standard Error|Mean
830375|NCT01235715|Secondary|Change in International Normalized Ratio (INR) Level on Day 2 Compared to Preoperatively|The INR, a measure of the clotting tendency of blood, is a ratio of a patient's prothrombin time (the time a blood plasma takes to clot after the addition of tissue factor) to a normal prothrombin time.|preoperatively and two days after surgery|All patients who completed the study were included in analysis.||ratio||Standard Deviation|Mean
830376|NCT01235715|Primary|Change in Hemoglobin on Day 0 Compared to Preoperatively||preoperatively and on the day of surgery|All patients enrolled in study were subject to analysis; occasionally a patient's levels were not taken or were not available for analysis for various reasons.||g/dL||Standard Deviation|Mean
830377|NCT01235728|Secondary|Mean Maximum Plasma Concentrations at Trough of Day 8, 15, 22, and 29 Following Topical Administration of MK-0873 to Psoriatic Patients|Plasma samples were collected at 12 hours post-dose on Days 8, 15, 22, and 28 to evaluate the mean maximum plasma concentration at trough of MK-0873.|Day 8, 15, 22, 29|The population consisted of all participants that received treatment, had no major protocol violations, and had MK-0873 plasma trough values available for the Day 8, 15, 22, and 28 treatment.||nM||Standard Deviation|Mean
830378|NCT01235728|Secondary|Least Squares Mean Percent Change From Baseline (Predose Day 1) of TLS Score for Lesions Treated With MK-0873 and Lesions Treated With Calcitriol|Each lesion was evaluated for 3 components: erythema, induration, and scaling. Each component was given a score using the following scale: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked, with increasing score reflecting increased lesion severity. The TLS score (range 0 to 12) is calculated as the sum of the 3 components.|Baseline and Day 29|The population consisted of all participants that received treatment, had no major protocol violations, and had TLS scores available at baseline and Day 29||Percent Change|Lesions|95% Confidence Interval|Least Squares Mean
830379|NCT01235728|Primary|Least Squares Mean Percent Change From Baseline (Predose Day 1) of Target Lesion Severity (TLS) Score for Lesions Treated With MK-0873 and Lesions Treated With MK-0873 Vehicle|Each lesion was evaluated for 3 components: erythema, induration, and scaling. Each component was given a score using the following scale: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked, with increasing score reflecting increased lesion severity. The TLS score (range 0 to 12) is calculated as the sum of the 3 components.|Baseline and Day 29|The population consisted of all participants that received treatment, had no major protocol violations, and had TLS scores available at baseline and Day 29.||Percent Change|Lesions|95% Confidence Interval|Least Squares Mean
830380|NCT01235741|Primary|Mean Change From Baseline to Month 6 Follow-Up in Lipids - Intent to Treat Population|Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Follow up was 6 months post last dose of randomized study medication. Lipids measured included total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, and triglycerides. Lipids were measured in milligrams per deciliter (mg/dL).|Baseline up to Month 6 Follow-Up|The intent to treat (ITT) population received at least one dose of randomized study treatment. The number analyzed in the ITT included those participants who provided a laboratory measurement up to Month 6 Follow-Up.||mg/dL||Standard Deviation|Mean
830381|NCT01235741|Primary|Mean Change From Baseline to Month 6 Follow-Up in Insulin - Intent to Treat Population|Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Follow up was 6 months post last dose of randomized study medication. Insulin measured in milliunits per liter (mU/L).|Baseline up to Month 6 Follow-Up|The intent to treat (ITT) population received at least one dose of randomized study treatment. The number analyzed in the ITT included those participants who provided a laboratory measurement.||mU/L||Standard Deviation|Mean
830382|NCT01235741|Primary|Mean Change From Baseline to 6 Month Follow-Up in Fasting Plasma Glucose - Intent to Treat Population|Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Follow up was 6 months post last dose of randomized study medication. Fasting glucose measured in milligrams per deciliter (mg/dL).|Baseline to 6 Month Follow-Up|The intent to treat (ITT) population received at least one dose of randomized study treatment. The number analyzed in the ITT included those participants who provided a laboratory measurement up to Month 6 Follow-Up.||mg/dL||Standard Deviation|Mean
830383|NCT01235741|Primary|Mean Change From Baseline to Month 6 Follow-Up in Heart Rate - Intent to Treat Population|Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Heart rate was measured in beats per minute (beats/min).|Baseline up to Month 6 Follow-Up|The intent to treat (ITT) population received at least one dose of randomized study treatment. The number analyzed in the ITT included those participants who provided a vital sign measurement.||beats/min||Standard Deviation|Mean
830384|NCT01235741|Primary|Mean Change From Baseline to Month 6 Follow-Up in Blood Pressure - Intent to Treat Population|Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Follow-up was up to 6 months post treatment. Blood pressure included systolic and diastolic pressures measured in millimeters of mercury (mmHg).|Baseline to Month 6 Follow-Up|The intent to treat (ITT) population received at least one dose of drug treatment. The number analyzed in the ITT included those participants who provided a vital sign measurement up to 6 Months follow-up.||mmHg||Standard Deviation|Mean
830385|NCT01235741|Primary|Number of Participants With Chemistry Laboratory Value of Potential Clinical Importance - Intent to Treat Population|Criteria for laboratory values of potential clinical importance for obese and overweight (BMI >= 25 kg/m^2) participants: Total bilirubin High (H) > 2 mg/dL; Plasma or serum glucose fasting or non-fasting H > 200 mg/dL, low (L) < 60 mg/dL; Albumin L <2.5 g/dL; Creatine kinase H > 3*Upper limit of Normal (ULN); Sodium L <130 milliequivalents per liter (mEq/L), H > 150 mEq/L; potassium L<3.0 mEq/L, H> 5.5 mEq/L; bicarbonate L<18 mEq/L, H>35 mEq/L;calcium L <8mg/dL, H> 11 mg/dL; triglycerides H> 500 mg/dL; Cholesterol L < 100 mg/dL, H > 350 mg/dL; Alkaline phosphatase H > 3*ULN; Gamma-glutamyltransferase H>3*ULN; creatinine males > 1.6 mg/dL, females > 1.4 mg/dL; alanine aminotransferase H > 3*ULN; aspartate aminotransferase H > 3*ULN; urea nitrogen H > 45 mg/dL; uric acid males > 10.0 mg/dL, females > 8.0 mg/dL; Phosphorus L < 1.0 mg/dL H > 6.0 mg/dL.|Screening to Month 6 Follow-Up|The intent to treat (ITT) population received at least one dose of randomized study treatment. The number analyzed in the ITT included those participants who provided a laboratory measurement.||participants|||Number
830386|NCT01235741|Primary|Number of Participants With Hematology and Urinalysis Laboratory Values of Potential Clinical Importance - Intent to Treat Population|Criteria for laboratory values of potential clinical importance for obese and overweight (BMI >= 25 kg/m^2) participants: Platelets high (H) >500,000/µL; low (L) <75,000/µL. Hematocrit males <36%, females <30%. Hemoglobin males <12 g/dL, females <10 g/dL. White blood cell count (WBC) H >18,000/µL; L <1,500/µL. Urine protein H >= 3+ or >= 500 mg/dL. Urine glucose H >= 3+ or >= 500 mg/dL. Urine ketones >= 3+ or Large.|Screening to 6 Month Follow-Up|The intent to treat (ITT) population received at least one dose of randomized study treatment. Number analyzed (n) in ITT included participants who provided a laboratory measurement. Hemoglobin, hematocrit n=27, 29 in placebo and pramlintide + metreleptin, respectively; urinalysis n=31, 29, in placebo and pramlintide + metreleptin, respectively.||participants|||Number
830387|NCT01235741|Primary|Number of Participants With Neutralizing Activity to Metreleptin at Early Termination or During Post Treatment Follow-Up - Intent to Treat Population Who Received Metreleptin|In vitro assays were conducted to determine if neutralizing activity to metreleptin developed in participants treated with at least one dose of the drug during the study. Baseline is Day 1 of the Randomization Period, prior to administration of metreleptin.|Baseline to Month 6 Follow-Up|||participants|||Number
830388|NCT01235741|Primary|Number of Participants With Anti-leptin Antibodies Who Received Metreleptin - Intent to Treat Population|Anti-leptin antibodies measured at Weeks 1 and 2 of drug treatment, early termination visit, and at Months 2, 4, and 6 post treatment follow-up in participants who received metreleptin.|Week 1 to Month 6 Follow-Up|All participants who received at least one dose of metreleptin and provided a sample to analyze; number analyzed (n) for Week 1, Week 2, early termination, Month 2, Month 4, Month 6 Follow-up were: n=22, 5, 35, 32, 25, 28.||participants|||Number
830389|NCT01235741|Primary|Change From Baseline to Week 2, and to Follow up Months 2, 4, 6 in Fasting Leptin Concentration - Intent to Treat Population|Participants who received metreleptin were analyzed; no placebo treated participants were analyzed. Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Leptin was measured in nanograms per milliliter (ng/mL).|Baseline to Month 6 Follow Up|All participants who received a dose of metreleptin and provided a sample were analyzed. Number of participants analyzed for Week 2, and follow up Months 2, 4, 6 were 6, and 33, 29, 29, respectively.||ng/mL||Standard Deviation|Mean
830390|NCT01235741|Primary|Number of Participants With Treatment Emergent Adverse Events and Number With Post Treatment Adverse Events - Intent to Treat Population|Treatment-Emergent Adverse Events are defined as those with an onset date and time on or after the first dose of randomized study medication and on or before the last dose of randomized study medication. Post-treatment Adverse Events are defined as those with an onset date after the date of last dose (imputed if not available) of randomized study medication. Participants experiencing multiple episodes of a given adverse event are counted once.|Day 1 up to Month 6 Follow-Up|The intent to treat (ITT) population received at least one dose of randomized study treatment.||participants|||Number
830391|NCT01235741|Secondary|Percent Change From Baseline to Week 1 and From Baseline to Month 6 Follow-up in Body Weight - Intent to Treat Population|Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Follow up was 6 months post last dose of randomized study medication.|Baseline up to Month 6 Follow-Up|The intent to treat (ITT) population received at least one dose of randomized study treatment. The number analyzed in the ITT included those participants who provided a measurement. Number analyzed (n) for Week 1 provided above; 6 Month Follow-Up n=27, 29, in placebo and Pramlintide + Metreleptin, respectively.||percentage of change in weight||Standard Deviation|Mean
830406|NCT01235975|Secondary|Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (μg/mL).|At Day 0 (PRE) and Month 1|The primary analysis was performed on a subset of of the 2 treatment groups and 2 age strata of the According-to-protocol (ATP) cohort for immunogenicity, 50% of subjects were tested for anti-PSA and anti-PSC and the other 50% of subjects were tested for anti-PSW-135 and anti-PSY.||μg/mL||95% Confidence Interval|Geometric Mean
830837|NCT01240330|Secondary|PFV Percent Augmentation|Peak Flow Velocity (PFV) from the compression phase subtracted from the PFV from the decompression phase divided by the PFV from the decompression phase expressed as the percent augmentation.|3 measurements/10 minute therapy|||percentages||Standard Deviation|Mean
830392|NCT01235897|Secondary|Best Disease Response by Response Evaluation Criteria in Solid Tumor (RECIST), Version 1.1|"Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Stable Disease (SD): Neither sufﬁcient shrinkage to qualify for PR nor sufﬁcient increase to qualify for PD, taking as reference the smallest sum diameters while on study
Non-PR/Non-PD: clinical response of chest wall disease not evaluable by RECIST"|60 days after dose inititation|Analysis included all patients receiving at least 8 weeks of study therapy||participants|||Number
830393|NCT01235897|Primary|Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose of MK-2206 Administered Weekly in Combination With Weekly Paclitaxel 80 mg/m^2 and Trastuzumab 2 mg/m^2|The MTD was defined as the dose level resulting in 3 or fewer DLTs in 11 patients, per the modified toxicity probability interval (TPI) method (Ji Y, Li Y, Nebiyou Bekele B: Dose-ﬁnding in phase I clinical trials based on toxicity probability intervals. Clin Trials 4:235-244, 2007), and confirmed in 4 additional patients. Based on interim toxicity data from other studies, the dose was not escalated beyond 135 mg weekly.|30 days from initiation of dose|Sixteen participants completed at least one cycle of therapy and were evaluable for DLT per protocol. Patients were assessed for DLT during the first 4-week cycle.||mg|||Number
830394|NCT01235910|Secondary|Blood Pressure||2 weeks||||||
830395|NCT01235910|Secondary|Aliskiren Plasma Concentrations|Maximum plasma concentration; area under the concentration-time curve, half-life, oral clearance|2 weeks||||||
830396|NCT01235910|Primary|Dose-normalized Cyclosporine Area Under the Plasma Concentration-time Curve (AUC)|The study was stopped due to difficulty finding patients who met the strict inclusion criteria. Only one patient was started on the study drug. as a result we did not analyze any cyclosporine PK (e.g.(AUCs) for this study.|7 days, 14 days, 30 days (End of Study)|||ng*h/ml/mg|||Number
830397|NCT01235923|Primary|Reticulocyte Count|reticulocyte count at 4 weeks (end of study)|4 weeks|Power analysis based on difference in mean retic count (baseline versus 4 weeks) of 75 (standard deviation 50), alpha 0.05, 80% power.||cells x 1000/microliter||Standard Error|Mean
830398|NCT01235923|Primary|Baseline Retic Count|retic count measured at study entry|baseline|All study subjects had baseline retic count measured.||x1000 cells/microliter||Standard Error|Mean
830399|NCT01235975|Secondary|Number of Subjects With New Onset Chronic Illnesses (NOCI)|NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.|Within 31 days (Day 0 to 30) after vaccination|The primary analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with vaccine administration documented.||Subjects|||Number
830400|NCT01235975|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Within 31 days (Day 0 to 30) after vaccination|The primary analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with vaccine administration documented.||Subjects|||Number
830401|NCT01235975|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within 31 days (Day 0 to 30) after vaccination|The primary analysis was performed on the Total Vaccinated cohort (TVC), which cohort included all subjects with vaccine administration documented.||Subjects|||Number
830402|NCT01235975|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue,gastrointestinal symptoms, headache and temperature [defined as orally temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = temperature above (>) 39.5 °C. Related = symptom assessed by the investigator as causally related to the study vaccination.|Within 4 days (Day 0 to 3) post-vaccination|The primary analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with vaccine administration documented.||Subjects|||Number
830403|NCT01235975|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest or pain that prevented normal every day activities. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.|Within 4 days (Day 0 to 3) post-vaccination|The primary analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with vaccine administration documented.||Subjects|||Number
830404|NCT01235975|Secondary|Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).|At Day 0 (PRE) and Month 1|The primary analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.||IU/mL||95% Confidence Interval|Geometric Mean
830405|NCT01235975|Secondary|Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations ≥ the Cut-off Value|The cut-off value for the anti-TT concentrations was greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).|At Day 0 (PRE) and Month 1|The primary analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.||Subjects|||Number
830466|NCT01236768|Other Pre-specified|Irritation and Itching at Application Site|"AG200-15 irritation and itching scores are defined as follows:
0=none
mild
moderate
severe"|6 months|Subject self-reported worse irritation score in a cycle.||Score||Standard Deviation|Mean
830407|NCT01235975|Secondary|Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations ≥ the Cut-off Value|The cut-off value for the anti-polysaccharide concentrations was greater than or equal to (≥) 2.0 micrograms per milliliter (μg/mL).|At Day 0 (PRE) and Month 1|The primary analysis was performed on a subset of of the 2 treatment groups and 2 age strata of the According-to-protocol (ATP) cohort for immunogenicity, 50% of subjects were tested for anti-PSA and anti-PSC and the other 50% of subjects were tested for anti-PSW-135 and anti-PSY.||Subjects|||Number
830408|NCT01235975|Secondary|Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations ≥ the Cut-off Value|The cut-off value for the anti-polysaccharide concentrations was greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL).|At Day 0 (PRE) and Month 1|The primary analysis was performed on a subset of of the 2 treatment groups and 2 age strata of the According-to-protocol (ATP) cohort for immunogenicity, 50% of subjects were tested for anti-PSA and anti-PSC and the other 50% of subjects were tested for anti-PSW-135 and anti-PSY.||Subjects|||Number
830409|NCT01235975|Secondary|rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers|Antibody titers were presented as geometric mean titers (GMTs).|At Day 0 (PRE) and Month 1|The primary analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.||Titers||95% Confidence Interval|Geometric Mean
830410|NCT01235975|Secondary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value|The cut-off value for the rSBA titers was greater than or equal to (≥) 1:128.|At Day 0 (PRE) and Month 1|The primary analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.||Subjects|||Number
830411|NCT01235975|Secondary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value|The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8.|At Day 0 (PRE) and Month 1|The primary analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.||Subjects|||Number
830412|NCT01235975|Primary|Vaccine Response to Meningococcal Antigens (MenA, MenC, MenW-135 and MenY)|Vaccine response for serum bactericidal assay using rabbit complement (rSBA) antibodies against Neisseria meningitides serogroups A, C , W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) was defined as: for initially seronegative subjects [rSBA titer below (<) 1:8], post-vaccination rSBA titer greater than or equal to (≥) 1: 32; for initially seropositive subjects with rSBA titer between 1:8 and 1:128, at least four-fold increase in rSBA titer from pre to post vaccination; and for initially seropositive subjects with rSBA titer ≥1:128, at least two-fold increase in rSBA titer from pre to post vaccination.|One month after vaccination (Month 1)|The primary analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.||Subjects|||Number
830413|NCT01236001|Secondary|Percentage of Subjects by Category of Clinical Evolution of Seizure Control at 6 Months|Clinical evolution of seizures following administration of VIMPAT compared to baseline before start of VIMPAT. The evolution of seizure control is subjectively assessed by the investigator on a four categorical scale, with options being 1=worsened, 2=stable, 3=improved, 4=much improved. If seizure control is worse, the investigator will try to document the reason|6 months|Of the 192 subjects in the Safety Set (SS), 168 subjects had Vimpat dosing data available at the 6-month visit and are included in this analysis.||percentage of participants|||Number
830414|NCT01236001|Secondary|Percentage of Subjects by Category of Clinical Evolution of Seizure Control at 3 Months|Clinical evolution of seizures following administration of VIMPAT compared to baseline before start of VIMPAT. The evolution of seizure control is subjectively assessed by the investigator on a four categorical scale, with options being 1=worsened, 2=stable, 3=improved, 4=much improved. If seizure control is worse, the investigator will try to document the reason.|3 months|Of the 192 subjects in the Safety Set (SS), 152 subjects had Vimpat daily dosing information available at the 3-month visit and are included in this analysis.||percentage of participants|||Number
830415|NCT01236001|Secondary|Percentage of Subjects by Category of Clinical Evolution of Seizure Control at Baseline|"This outcome will be only provided for subjects who were already treated by VIMPAT® at Baseline.
Clinical evolution of seizures following administration of VIMPAT compared to baseline before start of VIMPAT. The evolution of seizure control is subjectively assessed by the investigator on a four categorical scale, with options being 1=worsened, 2=stable, 3=improved, 4=much improved. If seizure control is worse, the investigator will try to document the reason."|Baseline|Of the 192 subjects in the Safety Set (SS), 105 subjects were treated with Vimpat at Baseline are included in this analysis.||percentage of participants|||Number
830416|NCT01236001|Secondary|Treatment Persistence of VIMPAT® After 6 Months|Treatment persistence is defined as the percentage of subjects being treated under VIMPAT® after a given duration (>=6 months).|>=6 months|Of the 192 subjects in the Safety Set (SS), 192 are included in this analysis.||percentage of participants|||Number
830417|NCT01236001|Secondary|Percentage of Subjects Who Received Concomitant Antiepileptic Drug Treatment|Concomitant antiepileptic drug (AED) treatments are defined as treatments which started after or at the date of the first administration of VIMPAT®.|From baseline to study termination (6 months)|Of the 192 subjects in the Safety Set (SS), 192 are included in this analysis.||percentage of patients|||Number
830418|NCT01236001|Primary|Galenic Formulation Repartition in Subjects Treated by VIMPAT® at 6 Months|VIMPAT is available as tablet and oral solution formulation in Belgium. The use of each galenic formulation will be presented with number of subjects by formulation.|6 months|Of the 192 subjects in the Safety Set (SS), 154 subjects had Vimpat dosing data available at the 6-month visit and are included in this analysis.||participants|||Number
830419|NCT01236001|Primary|Galenic Formulation Repartition in Subjects Treated by VIMPAT® at 3 Months|VIMPAT is available as tablet and oral solution formulation in Belgium. The use of each galenic formulation will be presented with number of subjects by formulation.|3 months|Of the 192 subjects in the Safety Set (SS), 137 subjects had Vimpat daily dosing information available at the 3-month visit and are included in this analysis.||participants|||Number
830420|NCT01236001|Primary|Galenic Formulation Repartition in Subjects Treated by VIMPAT® at Baseline|"This outcome will be only provided for subjects who were already treated by VIMPAT® at Baseline.
VIMPAT is available as tablet and oral solution formulation in Belgium. The use of each galenic formulation will be presented with number of subjects by formulation."|Baseline|Of the 192 subjects in the Safety Set (SS), 105 subjects were treated with Vimpat at Baseline are included in this analysis.||participants|||Number
830421|NCT01236001|Primary|Mean Total Daily Dose of VIMPAT® (mg) at 6 Months||6 months|Of the 192 subjects in the Safety Set (SS), 154 subjects had Vimpat dosing data available at the 6-month visit and are included in this analysis.||mg/day of Vimpat||Standard Deviation|Mean
830422|NCT01236001|Primary|Mean Total Daily Dose of VIMPAT® (mg) at 3 Months||3 months|Of the 192 subjects in the Safety Set (SS), 137 subjects had Vimpat daily dosing information available at the 3-month visit and are included in this analysis.||mg/day of Vimpat||Standard Deviation|Mean
830423|NCT01236001|Primary|Mean Total Daily Dose of VIMPAT® (mg) at Baseline|Mean total daily dose at baseline will be only provided for subjects who were already treated by VIMPAT® at Baseline.|Baseline|Of the 192 subjects in the Safety Set (SS), 105 subjects were treated with Vimpat at Baseline are included in this analysis.||mg/day of Vimpat||Standard Deviation|Mean
830424|NCT01236300|Primary|NPV (Negative Predictive Value)|"Using the descriptive criteria of the nCLE images of mucinous vs. non mucinous cysts determined in stage 1, we assessed diagnostic parameters of needle-based confocal laser endomicroscopy of for the detection of pancreatic cystic neoplasia in stage 2.
For patients who underwent surgery, a gold standard diagnosis was obtained by histopathological diagnosis of the surgical specimen. The local pathologist reviewed the histology slides and selected key areas for high-resolution digital photography. Digital images for all surgical cases were sent to the central pathologist (J.H.) for review.
In patients who did not undergo surgery, the final diagnosis was established by clinical diagnosis after a review by five investigators. These investigators independently reviewed the patients’ clinical factors, cross-sectional image findings, EUS findings and images, and cyst fluid results, and follow-up imaging studies ranging from 10 to 22 months, if available."|October 2011|Among 66 patients, 26 patients who categorized in Stage 1 only used to develop terms for specific findings, 8 patients were excluded due to insufficient information available to make a consensus diagnosis, and 31 patients in Stage 2 were analyzed.||percentage of participants||95% Confidence Interval|Number
830425|NCT01236300|Primary|PPV (Positive Predictive Value)|"Using the descriptive criteria of the nCLE images of mucinous vs. non mucinous cysts determined in stage 1, we assessed diagnostic parameters of needle-based confocal laser endomicroscopy of for the detection of pancreatic cystic neoplasia in stage 2.
For patients who underwent surgery, a gold standard diagnosis was obtained by histopathological diagnosis of the surgical specimen. The local pathologist reviewed the histology slides and selected key areas for high-resolution digital photography. Digital images for all surgical cases were sent to the central pathologist (J.H.) for review.
In patients who did not undergo surgery, the final diagnosis was established by clinical diagnosis after a review by five investigators. These investigators independently reviewed the patients’ clinical factors, cross-sectional image findings, EUS findings and images, and cyst fluid results, and follow-up imaging studies ranging from 10 to 22 months, if available."|October 2011|Among 66 patients, 26 patients who categorized in Stage 1 only used to develop terms for specific findings, 8 patients were excluded due to insufficient information available to make a consensus diagnosis, and 31 patients in Stage 2 were analyzed.||percentage of participants||95% Confidence Interval|Number
830426|NCT01236300|Primary|Specificity|"Using the descriptive criteria of the nCLE images of mucinous vs. non mucinous cysts determined in stage 1, we assessed diagnostic parameters of needle-based confocal laser endomicroscopy of for the detection of pancreatic cystic neoplasia in stage 2.
For patients who underwent surgery, a gold standard diagnosis was obtained by histopathological diagnosis of the surgical specimen. The local pathologist reviewed the histology slides and selected key areas for high-resolution digital photography. Digital images for all surgical cases were sent to the central pathologist (J.H.) for review.
In patients who did not undergo surgery, the final diagnosis was established by clinical diagnosis after a review by five investigators. These investigators independently reviewed the patients’ clinical factors, cross-sectional image findings, EUS findings and images, and cyst fluid results, and follow-up imaging studies ranging from 10 to 22 months, if available."|October 2011|Among 66 patients, 26 patients who categorized in Stage 1 only used to develop terms for specific findings, 8 patients were excluded due to insufficient information available to make a consensus diagnosis, and 31 patients in Stage 2 were analyzed.||percentage of participants||95% Confidence Interval|Number
830427|NCT01236300|Secondary|Overall Complication Rate|Assess the safety of nCLE, by recording any possible adverse event or complications occurring during or shortly after the EUSFNA and nCLE procedure|August 2011|||percentage of participants||95% Confidence Interval|Number
830428|NCT01236300|Primary|Sensitivity|"Using the descriptive criteria of the nCLE images of mucinous vs. non mucinous cysts determined in stage 1, we assessed diagnostic parameters of needle-based confocal laser endomicroscopy of for the detection of pancreatic cystic neoplasia in stage 2.
For patients who underwent surgery, a gold standard diagnosis was obtained by histopathological diagnosis of the surgical specimen. The local pathologist reviewed the histology slides and selected key areas for high-resolution digital photography. Digital images for all surgical cases were sent to the central pathologist (J.H.) for review.
In patients who did not undergo surgery, the final diagnosis was established by clinical diagnosis after a review by five investigators. These investigators independently reviewed the patients’ clinical factors, cross-sectional image findings, EUS findings and images, and cyst fluid results, and follow-up imaging studies ranging from 10 to 22 months, if available."|October 2011|Among 66 patients, 26 patients who categorized in Stage 1 only used to develop terms for specific findings, 8 patients were excluded due to insufficient information available to make a consensus diagnosis, and 31 patients in Stage 2 were analyzed.||percentage of participants||95% Confidence Interval|Number
830429|NCT01236326|Secondary|Recovered by 2 Months After Donation||2 months|||participants|||Number
830430|NCT01236326|Secondary|Days to Normal Day-to-day Activities||2 months|||days||Standard Deviation|Mean
830431|NCT01236326|Secondary|Days Before Going Back to Work||2 months|||days||Standard Deviation|Mean
830432|NCT01236326|Secondary|Days on Oral Pain Medication After Discharge||2 months|||days||Standard Deviation|Mean
830535|NCT01238341|Secondary|Successful Endoscopic Therapy||During procedure, up to 3 hours|||ERCPs|Participants||Number
830433|NCT01236326|Primary|The Primary End Point of the Study Was the Mean/Median Number of Days Postsurgery Required for Each Group to Return to 100% Functioning Capacity.|"The Primary Endpoint of the Study Will be Patient Self-reported Return to 100%, as Measured by the Number of Days Post-surgery That the Patient Reports His or Her Return to 100% Functioning Capacity."|1 year|||days||Standard Deviation|Mean
830434|NCT01236339|Secondary|Liver Disease Complications (Adverse Events)|Overall frequency and component frequencies. Complications will include hepatic encephalopathy, hepatic hydrothorax, hepatoma, hepatorenal syndrome (Type 1 or Type 2), hyponatremia (<130mEq / L), spontaneous bacterial peritonitis, and variceal bleeding.|Through 24 months|||participants|||Number
830435|NCT01236339|Secondary|Procedural Success|"Successful creation of a VIATORR(R) device lined portosystemic shunt spanning a hepatic vein and intrahepatic branch of the portal vein
*Note: Control (LVP) arm includes only subjects who crossed over to TIPS"|Time of TIPS Procedure (within 2 weeks of enrollment for TIPS arm, at least 6 months after enrollment for Control arm crossover participants)|||participants|||Number
830436|NCT01236339|Secondary|Frequency of Hepatic Encephalopathy|Number of episodes of West Haven grade 2 or greater|Through 24 months|||Number of episodes|||Number
830437|NCT01236339|Secondary|Frequency of Paracentesis|Number of paracentesis post randomization|Through 24 months|||Number of episodes|||Number
830438|NCT01236339|Secondary|Time to Transplant|"Time from randomization to transplant. Subjects without an event will be censored at the date of last follow-up or date of death without transplant.
*Note: Outcome measure entered is number of subjects who received a liver transplant at time of study termination."|Through 24 months|||participants|||Number
830439|NCT01236339|Secondary|Overall Survival|"Time from randomization to death from any cause. Subjects without an event will be censored at the date of last follow-up. >
*Note: Outcome measure entered below is number of subjects alive at time of study termination."|Through 24 months|||participants|||Number
830440|NCT01236339|Primary|Transplant-free Survival|"Time from randomization to death from any cause prior to transplant. Subjects who undergo liver transplant will be censored at the time of transplant. Subjects without an event will be censored at the date of last follow-up.
Note: The outcome entered below is the number of participants who were either alive or had a liver transplant at time of study termination."|Through 24 months|||participants|||Number
830441|NCT01236365|Primary|Hs-CRP Levels Assessed at Randomization and 6 Months|To assess if the use of statins in children with type 1 DM decreases the concentration of inflammatory markers.|Randomization and 6 months|||mg/dL||Inter-Quartile Range|Median
830442|NCT01236365|Secondary|Subclinical Atherosclerosis and Vascular Stiffness With the Use of Abdominal Aortic MRI.|T1DM patients will have an MRI scan of the abdominal aorta using an image acquisition protocol to measure subclinical atherosclerosis and arterial stiffness. Subjects will be rescanned at the conclusion of the 6 month trial. A group of healthy, non diabetic age-matched controls will be scanned as well.|6 months||||||
830443|NCT01236365|Secondary|Gene Expression and Concentration of Key Molecules That Participate in the Inflammatory Process and Arterial Plaque Formation.|We will restrict participation in protocol #2 to those with T1DM for >3 years and a HbA1C >8% using a stratified balanced randomization. Blood will be withdrawn for a special genetic test. Age-matched, non-diabetic healthy controls will be recruited for comparison.|6 months||||||
830444|NCT01236365|Secondary|Relationship Between Glycemic Variability- Measured by the Mean Amplitude of Glycemic Excursion With Continuous Glucose Monitoring.|At randomization, 3 and 6 months a CGM (IPro®, Medtronic Minimed) will be worn blindly for 6d to assess glucose variability to correlate mean amplitude of glycemic excursions (MAGE) with changes in Lp particles and hsCRP.|Randomization and 6 months||||||
830445|NCT01236365|Primary|LDL-C Levels Assessed at Randomization and 6 Months|To assess if the use of statins in children with type 1 DM is safe, improves measures of LDL-C. Subjects will have a physical exam, laboratories, nutritional counseling and moderate aerobic exercise recommended. Diabetes management will be intensified. At 3 months fasting lipoprotein fractions (ion mobility)re-drawn and if LDL-C >100mg/dl patients will be randomized to treatment with statins or placebo for 6 months, randomization stratified by BP and microalbuminuria, duration of diabetes and HgA1C. At 1 month safety labs will be repeated and blood withdrawn again at 3 and 6 months from baseline.|Randomization and 6 months|Adjusted for age, gender and ISS (Insulin sensitivity score)||mg/dL||Standard Error|Mean
830446|NCT01236378|Secondary|Number of Participants With Estimated Glomerular Filtration Rate (GFR) Less Than (<) 60 mL/Min/1.73 m^2|GFR, an index of kidney function, describes flow rate of filtered fluid through the kidney. GFR can be measured directly or estimated using established formulas. GFR was calculated using the Simplified Modification of Diet in Renal Dysfunction (MDRD) GFR equation. Normal GFR is >90 mL/min/1.73 m^2; children and older people usually have lower GFR. Often, kidney transplant recipients do not have normal GFRs. Lower values indicate poor kidney function. GFR <15 mL/min/1.73 m^2 is consistent with kidney failure. For this posting, the number of subjects with a GFR <60 mL/min/1.73 m^2 is listed.|From baseline up to Day 4|All participants.||participants|||Number
830447|NCT01236378|Secondary|Number of Participants With Serum Creatinine Levels More Than (>) 1.3 Times the Upper Limit of Normal|Serum creatinine, an indicator of kidney function, formed from the metabolism of creatine, commonly found in blood, urine, and muscle tissue, is removed from blood by kidneys and excreted in urine. Increased creatinine in blood indicates decreased kidney function. Creatinine levels are age, gender and race dependent as they are related to an individual’s muscle mass. Renal transplant recipients may have elevated serum creatinine. For this study an abnormal serum creatinine level is defined as 1.3 times the upper limit of normal (ULN) for the laboratory where the determination was performed.|From baseline up to Day 4|All participants.||participants|||Number
830448|NCT01236378|Primary|Apparent Oral Clearance (CL/F)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.|Predose (0 hour) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 and 24 hours post dose|PK Parameter Analysis Population||liter per hour (L/h)||Standard Deviation|Mean
830563|NCT01238588|Primary|Changes in Fluorodeoxyglucose (FDG)-Positron Emission Tomography (PET): FDG-PET/CT Dual Scan Score||Baseline and 6 months|Scans were done but not analyzed due to early study termination (per funding source).|||||
830449|NCT01236378|Primary|Degree of Fluctuation (DF)|DF, also known as peak to trough fluctuation (PTF) (calculated as [Cmax minus Ctrough] divided by Cave), is a unit-less ratio of the Cmax to Ctrough decrease expressed as a fraction of the average concentration during a dosing interval.|Predose (0 hour) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 and 24 hours post dose|PK Parameter Analysis Population||ratio||Standard Deviation|Mean
830450|NCT01236378|Primary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) at Steady State||Predose (0 hour) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 and 24 hours post dose|PK Parameter Analysis Population||nanogram hour per milliliter (ng*h/mL)||Standard Deviation|Mean
830451|NCT01236378|Primary|Average Blood Concentration at Steady State (Cave,ss)||Predose (0 hour) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 and 24 hours post dose|PK Parameter Analysis Population||ng/mL||Standard Deviation|Mean
830452|NCT01236378|Primary|Observed Blood Trough Concentration at Steady State (Ctrough,ss)||Predose (0 hour) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 and 24 hours post dose|PK Parameter Analysis Population||ng/mL||Standard Deviation|Mean
830453|NCT01236378|Primary|Time to Reach Maximum Observed Blood Concentration at Steady State (Tmax,ss)||Predose (0 hour) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 and 24 hours post dose|PK Parameter Analysis Population||hours||Full Range|Median
830454|NCT01236378|Primary|Maximum Observed Blood Concentration at Steady State (Cmax,ss)||Predose (0 hour) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 and 24 hours post dose|PK parameter analysis population: All treated participants who had at least 1 of the PK parameters of primary interest.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
830455|NCT01236391|Secondary|Mean Change From Baseline to Cycle 5 in EORTC QLQ-C30 Global Health Status Score|Mean change from baseline to Cycle 5 in the European Organisation for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30) Global Health Status Score according to EORTC QLQ-C30 Scoring Manual (3rd Edition, 2001). For global health status, positive changes indicated better health status or functioning, and negative changes indicated worsening of health status or functioning. Scale scores range from 0 to 100. A change in 5 to 10 points in either direction represents a small change; 10 to 20 points represents a moderate change and greater than 20 points represents a large change.|From Baseline to Cycle 5 (Week 20)|||scores on a scale||Standard Deviation|Mean
830456|NCT01236391|Secondary|PCI-32765 and Its Metabolite (PCI-45227) AUC0-24h After Repeat Dosing of PCI-32765|Area under the plasma concentration-time curve using data collected at 0, 1, 2, 4, 6-8, and 24 hours post dose (AUC0-24h)|Performed During the First Month of Receiving PCI-32765|PK samples were collected in a subset of participants (n=48) in this trial (n=111). PK parameters reported here reflects those that were PK evaluable from the 48 participants.||AUC0-24h (ng*h/mL)||Standard Deviation|Mean
830457|NCT01236391|Secondary|Number of Participants With Treatment Emergent Adverse Events (AEs)|Number of participants who had experienced at least one treatment emergent AE|From first dose of PCI-32765 to within 30 days of last dose for each participant or until study closure|||participants|||Number
830458|NCT01236391|Primary|Percentage of Participants Achieving Response|The primary endpoint of the study was overall response rate (ORR), defined as the proportion of participants who achieved a best overall response of complete response (CR) or partial response (PR), according to the revised International Working Group Criteria for non-Hodgkin’s lymphoma (Cheson et al, 2007), as assessed by the investigator. CR is a complete disappearance of all disease, no new lesions, lymph nodes must have regressed and be PET negative, spleen and liver should not be palpable and without nodules, and bone marrow must be negative. PR is a >/= 50% decrease in the sum of the product of diameters of the target lesions, and >/= 50% decrease of splenic and hepatic nodules from baseline, no new lesions and no increase in the size of liver, spleen or non-target lesions.|The median follow-up time on study for all treated participants is 15.3 (range 1.9 - 22.3) months|Participants who received at least 1 dose of PCI-32765 and constitute the all treated population||percentage of participants with response||95% Confidence Interval|Number
830459|NCT01236534|Secondary|Number of Participants With Diarrheic Events.|To determine the safety of lubiprostone based on adverse event (AE) type, frequency, and severity. Hypothesis: AE type, frequency, and severity will be comparable in lubiprostone and placebo treated patients.|21 days|per protocol||participants|||Number
830460|NCT01236534|Primary|Number of Spontaneous Bowel Movements in Patients With Multiple Sclerosis (MS)-Associated Constipation Per Day.|Number of of lubiprostone 24 mcg twice daily on spontaneous bowel movements (SBM) in patients with multiple sclerosis (MS)-associated constipation per day. Hypothesis: Lubiprostone-treated patients will have more SBM's than placebo-treated patients.|21 days|per protocol||spontaneous bowel movements||Standard Deviation|Mean
830461|NCT01236573|Primary|Response (Complete Response (CR) + Partial Response (PR)) to Therapy|Response was determined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline um LD. Progressive disease (PD) is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more lesions.|4 years|||participants|||Number
830462|NCT01236573|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|49 months and 20 days|||participants|||Number
830463|NCT01236573|Primary|Maximum Tolerated Dose (MTD)|The MTD was determined by evaluating dose limiting toxicities (DLT) of participants that received increasing doses of intravenous infusion of IL-12 gene transduced tumor infiltrating lymphocytes (TIL) (i.e., 1x10^6, 3x10^6, 3x10^7, 1x10^7, 3x10^7, 1x10^8, 3x10^8, 1x10^9, and 3x10^9) in cohorts 1-10. Maximum tolerated cell dose is the highest dose at which </= 1 of 6 patients experienced a DLT (i.e. grade 2 or greater allergic reaction)).|4 years|||Cells|||Number
830464|NCT01236768|Other Pre-specified|Adhesion at Application Site|"Measurement of adhesion of application site is defined as follows:
0: >=90% adhered (no lifting)
>=75% adhered but <90% (some edges showing lifting)
>=50% adhered but <75% (half of the patch lifts off)
<50% (> half of patch lifts off, but not detached)
patch completely detached"|6 months|Subjects that have documented adhesion scores.||Score||Standard Deviation|Mean
830465|NCT01236768|Other Pre-specified|Pharmacokinetics of Levonorgestrel (LNG) and Ethinyl Estradiol (EE)|Measurement of plasma levels of levonorgestrel and ethinyl estradiol.|3 months and 6 months|Number of subjects with available LNG data for cycle 3 or cycle 6||pg/mL||95% Confidence Interval|Mean
830467|NCT01236768|Other Pre-specified|Cycle Control|The percentage of cycles with breakthrough bleeding or spotting episodes during all cycles. Numerator is total number of cycles with event, denominator is total number of cycles.|6 months|Subjects with relevant breakthrough bleeding (BTB) and/or spotting (BTS), and drug information for a cycle.||percent cycles with BTB or BTS|||Number
830468|NCT01236768|Secondary|Safety|Adverse events|6 months|Any subject who applied a patch.||Events|||Number
830469|NCT01236768|Primary|Pregnancy Reported as Pearl Index|Pearl Index is the number of on-therapy pregnancies times 1300 divided by the number of 28-day on-therapy cycles and is an estimate of the number of pregnancies per 100 woman-years of product use.|6 months|Intent-to-treat population ages 18-35.||Pearl Index||95% Confidence Interval|Number
830470|NCT01237054|Secondary|Comparison of Microvessel Density (MVD) Between MGUS and SMM/MM Groups|Microvessel density was estimated by determining the average number of CD34-stained microvessels in 10 areas of maximal MVD counted at a high-power field (h.p.f. x 500 magnification).|60 days|Serum was not available for three patients in the SMM group.||microvessels/hpf||Standard Error|Mean
830471|NCT01237054|Secondary|Comparison of Serum Angiogenic Marker Reverse Contrast Transfer Rate (Kep) Between MGUS and SMM/MM Groups|Pharmacokinetic parameter Kep was measured by dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI).|60 days|Serum was not available for three patients in the SMM group.||per min||Standard Error|Mean
830472|NCT01237054|Secondary|Comparison of Reverse Contrast Transfer Rate (Kep) and Forward Contrast Transfer Rate (Ktrans) Among Patients With MGUS, SMM, and MM|Pharmacokinetic parameters Kep and Ktrans were measured by dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI).|60 days|Three patients with MM did not undergo bone marrow biopsies and were not included in this analysis.||per min||Full Range|Median
830473|NCT01237054|Secondary|Comparison of Microvessel Density (MVD) Among Patients With MGUS, SMM, and MM|Microvessel density was estimated by determining the average number of cluster of differentiation 34 (CD34)-stained microvessels in 10 areas of maximal MVD counted at a high-power field (h.p.f. x 500 magnification). Large vessels and vessels in the periosteum on bone were excluded. Areas of staining with no discrete breaks were counted as a single vessel. The presence of a lumen was not required.|60 days|Three patients with MM did not undergo bone marrow biopsies and were not included in this analysis.||microvessels/hpf||Full Range|Median
830474|NCT01237054|Secondary|Comparison of Serum Angiogenic Markers Ang2 (Angiopoietin), G-CSF (Granulocyte-colony Stimulating Factor), Follistatin, HGF (Hepatocyte Growth Factor), FGF-1, Endothelin 1, and VEGF-A (Vascular Endothelial Growth Factor-A) Between MGUS and SMM/MM Groups|The assay was performed according to the manufacture's protocol, and all samples were diluted 1:3. Cytokine values were calculated using a five-parameter standard curve with Bio-Plex Manager 6.1.|60 days|Serum was not available for three patients in the SMM group.||pg/ml||Standard Error|Mean
830475|NCT01237054|Primary|Count of Participants With Positive DCE-MRI Imaging Results|DCE-MRI, an FDA approved gadolinium chelate (e.g. Magnevist, Berlex Laboratories, NJ, USA) will be administered intravenously at 3 cc/sec using an automated pump injector (Medrad, Pittsburgh, PA, USA). The criteria was presence of early and diffuse hyper-enhancement compared to the surrounding bone marrow. The pattern of marrow involvement on MRI was characterized as: (1) normal when there was no evidence of abnormal signal intensity; (2) focal, which consisted of localized areas of abnormal marrow; the lesions are darker than yellow marrow and slightly darker than or isointense to red marrow on T1-weights images; (3) diffuse, in which normal bone marrow signal intensity is completely absent, the intervertebral disks appear brighter than or isointense to the diseased marrow; and finally (4) heterogeneous that consists of innumerable small foci of disease on a background of intact marrow, with small dark lesions on T1-weighted images, which become bright on T2-weighted image.|60 days|Missing means the imaging test was not done. Unclear means it is indeterminate whether an imaging result is positive or negative.||Participants|||Count of Participants
830476|NCT01237054|Primary|Count of Participants With Positive and Negative 18F-FDG PET CT and F18-NaF PET CT Imaging Results in Individuals With MGUS, SMM, and MM.|18F-FDG PET CT and F18-NaF PET CT imaging results were compared in participants with MGUS, SMM, and MM. Lesions were considered positive if focal uptake corresponded to lesions identified on CT for NaF and negative if no uptake seen in lesions. Criteria to define FDG positivity included parameters published by Zamagni et al with focal abnormal uptake more intense than background.|60 days|||Participants|||Count of Participants
830477|NCT01237080|Primary|Time to Intubate||From when the anaesthetist picked up the GS / FT until a typical capnogram was seen on the capnograph.|The sample size was calculated to 40 in each group (50 patients were included in each group): minimum relevant difference in intubation time of 20 s and a standard deviation of 28 s. A significance level of 0.05 and an acceptable risk of Type 2 error of 0.1 were used.||sec||95% Confidence Interval|Mean
830478|NCT01237080|Secondary|Postoperative Throat Pain.||one hour postoperative||||||
830479|NCT01237080|Secondary|Postoperative Hoarseness.||one hour postoperative.||||||
830480|NCT01237080|Secondary|Intubation of the Esophagus.||detected immediately||||||
830481|NCT01237080|Secondary|Subjectively Intubation Difficulty||measured immediately on a visual analogue scale.||||||
830482|NCT01237080|Secondary|Mucosal Lesion||inspection during intubation and one hour postop.||||||
830483|NCT01237080|Secondary|Lowest Saturation During Intubation.||measured on the monitor||||||
830484|NCT01237080|Primary|Number of Patients Intubated in the First Attempt|The intubation attempt was considered a failure if the GS or the FT was removed from the patient’s mouth and required reinsertion or if the cuff had been inflated and the tube needed to be replaced (e.g., in oesophageal intubation).|please see description|||participants|||Number
830485|NCT01237197|Primary|Percent Change From Baseline in Body Mass Index at 3-months|As results are measured by BMI reduction, percent change (reduction) in BMI is primary outcome measure.|Baseline and 3-months|||percentage of change in BMI||Standard Deviation|Mean
830486|NCT01237223|Secondary|Number of Participants With Adverse Events, Serious Adverse Events and Death|Number of patients with adverse events regardless of study drug relationship during the double-blind treatment period were reported. Serious adverse events of double blind period were reported.|8 weeks|Safety set: All patients who received at least one dose of double-blind study medication.||Participants|||Number
830564|NCT01238640|Secondary|Product Dissolution Time|Product Dissolution Time is the time from administration until the investigational products were completely dissolved.|During 10 hours post-dose|||Minutes||Standard Deviation|Mean
830487|NCT01237223|Secondary|Percentage of Participants Achieving a Successful Response Rate|The response rate was defined as percentage of participants who achieved msDBP < 90 mmHg or its reduction ≥ 10 mmHg from baseline to endpoint.|8 weeks|Full analysis set (FAS) included all randomized patients received at least one dose of double-blind study medication||percentage of participants|||Number
830488|NCT01237223|Secondary|Percentage of Participants Achieving Blood Pressure Control at Endpoint|Blood pressure control is defined as having as a msDBP < 90 mmHg and a msSBP < 140 mmHg.|8 weeks|Full analysis set (FAS) included all randomized patients received at least one dose of double-blind study medication||percentage of participants|||Number
830489|NCT01237223|Secondary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) to End of Study (Week 8)|Sitting blood pressure was measured at trough (24 hours ± 2 hours post dose) and recorded at all study visits. At the first study visit, blood pressure was measured in both arms and the arm with highest sitting DBP was found and used for all subsequent readings throughout the study. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these three sitting blood pressure measurements were used as the average sitting blood pressure for that visit. Analysis of covariance (ANCOVA) model contained treatment and region as two factors and baseline as a covariate.|Baseline, Week 8|Full analysis set (FAS): All randomized patients received at least one dose of double-blind study medication.||mm Hg||Standard Error|Least Squares Mean
830490|NCT01237223|Primary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) to End of Study (Week 8)|Sitting blood pressure was measured at trough (24 hours ± 2 hours post dose) and recorded at all study visits. At the first study visit, blood pressure was measured in both arms and the arm with highest sitting DBP was found and used for all subsequent readings throughout the study. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these three sitting blood pressure measurements were used as the average sitting blood pressure for that visit. Analysis of covariance (ANCOVA) model contained treatment and region as two factors and baseline as a covariate.|Baseline, Week 8|Full analysis set (FAS): All randomized patients received at least one dose of double-blind study medication.||mm Hg||Standard Error|Least Squares Mean
830491|NCT01237301|Secondary|The Secondary Objective is to Determine the Incremental Benefit of CGM for Clinical Decision-making.|"Outcome will be measured by:
i. HbA1c ii. Glucose exposure (area under the diurnal median curve) iii. Glucose variability (inter-quartile range) iv. Glucose stability (hourly change in the median curve) v. Incidence of hypoglycemia (degree, duration, frequency)"|16 weeks||||||
830492|NCT01237301|Primary|Percentage Change in Hemoglobin A1c||2 week baseline to 18 week final|Per Protocol||percentage of HbA1c||Standard Deviation|Mean
830493|NCT01237327|Secondary|Time to Treatment Failure (TTF)|TTF = time between first day of study treatment and date of diagnosis of progression, withdrawal from study treatment for any reason, administration of other antitumor treatment, or death from any cause, whichever was the earliest event.|Every 12 weeks up to 6 years|ITT||months||95% Confidence Interval|Median
830494|NCT01237327|Secondary|Time to Tumor Progression (TTP)|TTP = time between first day of study treatment and date of documented disease progression, or date of tumor-related death in the absence of previously documented progressive disease (PD). PD defined as a 25% or greater increase in size of 1 or more lesions compared to smallest previous assessment, or appearance of new lesion, or unequivocal worsening of bone lesions, or progression of nonevaluable lesions.|Every 12 weeks up to 6 years|ITT||months||95% Confidence Interval|Median
830495|NCT01237327|Secondary|Duration of Response (DR)|Duration of objective response (complete response [CR] or partial response [PR]) calculated from date objective response was first documented to date of progressive disease. For subjects proceeding from PR to CR, the onset of PR was taken as the onset of objective response.|Every 12 weeks up to 6 years|ITT.||months||95% Confidence Interval|Median
830496|NCT01237327|Secondary|Objective Response Rate (ORR)|Percentage of participants achieving an objective response (OR) defined as complete response (CR) or partial response (PR) out of the total number of participants randomized in each treatment group|Every 12 weeks up to 6 years|ITT||percentage of participants|||Number
830497|NCT01237327|Primary|Overall Survival|Overall survival in months measured from date of starting treatment in core study to date of death for any reason.|Every 12 weeks up to 6 years|Intent-to-treat (ITT): participants randomized to study medication in core study who consented to participation in extension study.||months||95% Confidence Interval|Median
830498|NCT01237340|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs)|Adverse events (AEs): Any untoward medical occurrence in the form of signs, clinically significant abnormalities in laboratory findings, diseases, symptoms, or worsening of complications. TEAEs: AEs occurring after the first administration of Saizen® solution for injection (on Day 1) up to the scheduled routine post treatment follow-up visit (4 weeks [28 days] after the final administration of Saizen® solution for injection).|Day 1 up to 28 days after last dose of study treatment|Safety population consisted of all the participants who received at least 1 dose of study medication and had at least one post-baseline safety assessment.||participants|||Number
830499|NCT01237340|Secondary|Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels||Baseline, Week 2, Week 4, Week 8, Week 13, Week 18, Week 26|"Safety population consisted of all the participants who received at least 1 dose of study medication and had at least one post-baseline safety assessment. Here n signifies number of participants analyzed at that particular time point for each arm group respectively."||nmol/L||Standard Deviation|Mean
830500|NCT01237340|Secondary|Insulin-like Growth Factor-I Standard Deviation Score (IGF-1 SDS)|Insulin-like Growth Factor-1 Standard Deviation Score (IGF-1 SDS) was provided by the central laboratory; its calculation is based on the actual value of IGF-1 minus mean reference value of IGF-1 divided by reference standard deviation of IGF-1.|Baseline, Week 2, Week 4, Week 8, Week 13, Week 18, Week 26|"Safety population consisted of all the participants who received at least 1 dose of study medication and had at least one post-baseline safety assessment. ‘N’ (number of participants analyzed) = participants who were evaluated for this measure and n= participants who were analyzed at that particular time point for each arm group respectively."||standard deviation score||Standard Deviation|Mean
830501|NCT01237340|Secondary|Insulin-like Growth Factor-I (IGF-1) Levels||Baseline, Week 2, Week 4, Week 8, Week 13, Week 18, Week 26|"Safety population consisted of all the participants who received at least 1 dose of study medication and had at least one post-baseline safety assessment. ‘N’ (number of participants analyzed) = participants who were evaluated for this measure and n= participants who were analyzed at that particular time point for each arm group respectively."||nanomole per liter (nmol/L)||Standard Deviation|Mean
830502|NCT01237340|Secondary|Number of Participants Who Developed Positive Neutralizing Antibodies (NAbs+) to Saizen®|Neutralizing antibodies (NAbs) are defined as a subgroup of BAbs which bind to the active sites of the investigational drug molecule (Saizen®) and therefore neutralize its potency.|Baseline up to Week 26|MITT population consisted of all the participants who received at least 1 dose of study medication and had at least one post-baseline BAbs assessment.||participants|||Number
830503|NCT01237340|Primary|Number of Participants Who Developed Positive Binding Antibodies (BAbs+) to Saizen®|Binding antibodies (BAbs) are all antibodies which are capable of binding to the investigational drug molecule (Saizen®), irrespective of their binding site.|Baseline up to Week 26|Modified Intent-to-Treat (MITT) population consisted of all the participants who received at least 1 dose of study medication and had at least one post-baseline BAbs assessment.||participants|||Number
830504|NCT01237353|Secondary|Duration of Gastric pH Status|When subject's pH remained above 4.0 for at least 15 minutes, a 1500 mg dose of betaine HCl was given orally with 90 mL of water, and gastric pH was continuously monitored for 2 hours|2 hours after dose of betaine HCl|||minutes||Standard Deviation|Mean
830505|NCT01237353|Primary|Change in Gastric pH After Administration of Betaine Hydrochloride (HCl)|Gastric pH levels monitored with a Heidelberg pH capsule (HC) which sends real-time signals to a computer system that visually plots intestinal pH on a minute-by-minute basis. When subject's pH remained above 4.0 for at least 15 minutes, a 1500 mg dose of betaine HCl was given orally with 90 mL of water, and gastric pH was continuously monitored for 2 hours.|30 minutes|||units on a scale||Standard Deviation|Mean
830506|NCT01237613|Secondary|Clinical Evaluation Including Adverse Events||12 months|Data not analyzed as study was terminated due to sponsor bankruptcy.|||||
830507|NCT01237613|Secondary|Return to Work and Previous Physical Activities||12 months|Data not analyzed as study was terminated due to sponsor bankruptcy.|||||
830508|NCT01237613|Secondary|Subjective Evaluation of Treatment||12 months|Data not analyzed as study was terminated due to sponsor bankruptcy.|||||
830509|NCT01237613|Secondary|Range of Motion, Strength and Calf Circumference||12 months|Data not analyzed as study was terminated due to sponsor bankruptcy.|||||
830510|NCT01237613|Secondary|General Measure of Health-related Quality of Life Using the EuroQoL (EQ-5D) Questionnaire||12 months|Data not analyzed as study was terminated due to sponsor bankruptcy.|||||
830511|NCT01237613|Secondary|The American Orthopaedic Foot and Ankle Society (AOFAS) Clinical Rating System for Ankle-hindfoot||12 months|Data not analyzed as study was terminated due to sponsor bankruptcy.|||||
830512|NCT01237613|Secondary|Clinical Evaluation Including Adverse Events||6 months|Data not analyzed as study was terminated due to sponsor bankruptcy.|||||
830513|NCT01237613|Secondary|Return to Work and Previous Physical Activities||6 months|Data not analyzed as study was terminated due to sponsor bankruptcy.|||||
830514|NCT01237613|Secondary|Subjective Evaluation of Treatment||6 months|Data not analyzed as study was terminated due to sponsor bankruptcy.|||||
830515|NCT01237613|Secondary|Range of Motion, Strength and Calf Circumference||6 months|Data not analyzed as study was terminated due to sponsor bankruptcy.|||||
830516|NCT01237613|Secondary|General Measure of Health-related Quality of Life Using the EuroQoL (EQ-5D) Questionnaire||6 months|Data not analyzed as study was terminated due to sponsor bankruptcy.|||||
830517|NCT01237613|Secondary|The American Orthopaedic Foot and Ankle Society (AOFAS) Clinical Rating System for Ankle-hindfoot||6 months|Data not analyzed as study was terminated due to sponsor bankruptcy.|||||
830518|NCT01237613|Secondary|Clinical Evaluation Including Adverse Events||3 months|Data not analyzed as study was terminated due to sponsor bankruptcy.|||||
830519|NCT01237613|Secondary|Return to Work and Previous Physical Activities||3 months|Data not analyzed as study was terminated due to sponsor bankruptcy.|||||
830520|NCT01237613|Secondary|Subjective Evaluation of Treatment||3 months|Data not analyzed as study was terminated due to sponsor bankruptcy.|||||
830521|NCT01237613|Secondary|Range of Motion, Strength and Calf Circumference||3 months|Data not analyzed as study was terminated due to sponsor bankruptcy.|||||
830522|NCT01237613|Secondary|General Measure of Health-related Quality of Life Using the EuroQoL (EQ-5D) Questionnaire||3 months|Data not analyzed as study was terminated due to sponsor bankruptcy.|||||
830523|NCT01237613|Secondary|The American Orthopaedic Foot and Ankle Society (AOFAS) Clinical Rating System for Ankle-hindfoot||3 months|Data not analyzed as study was terminated due to sponsor bankruptcy.|||||
830524|NCT01237613|Primary|The Foot Function Index (FFI) for Evaluation of Foot Pain and Disability||12 months|Data not analyzed as study was terminated due to sponsor bankruptcy.|||||
830525|NCT01237613|Primary|The Foot Function Index (FFI) for Evaluation of Foot Pain and Disability||6 months|Data not analyzed as study was terminated due to sponsor bankruptcy.|||||
830526|NCT01237613|Primary|The Foot Function Index (FFI) for Evaluation of Foot Pain and Disability||3 months|Data not analyzed as study was terminated due to sponsor bankruptcy.|||||
830527|NCT01238211|Secondary|Overall Survival|Overall survival (OS) is defined as time from registration to death. The median OS with 95% CI was estimated using the Kaplan-Meier method.|Up to 10 years||||||
830528|NCT01238211|Secondary|Disease-free Survival|Disease free survival (DFS) is defined as the time from achievement of CR to relapse or death, whichever comes first. The median DFS with 95% CI was estimated using the Kaplan-Meier method.|Up to 10 years||||||
830529|NCT01238211|Secondary|Cumulative Incidence of Death||Up to 10 years||||||
830530|NCT01238211|Secondary|Cumulative Incidence of Relapse||Up to 10 years||||||
830531|NCT01238211|Secondary|Complete Response Rate|"Percentage of participants who achieve a CR.
CR is defined in the above outcome measure."|Up to 10 years||||||
830532|NCT01238211|Secondary|Event-free Survival|"Event free survival (EFS) is defined as the time from registration to failure to achieve complete remission (CR), relapse after CR is attained or death, whichever comes first. The median EFS with 95% CI was estimated using the Kaplan-Meier method,
Complete remission (CR) is defined as: disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count > 1.0 x 10^9/L and platelet count > 100 x 10^9/L, and normal bone marrow differential (< 5% blasts)."|Up to 10 years||||||
830533|NCT01238211|Primary|30 Day Survival Rate|Percentage of participants who were alive 30 days after starting induction treatment.|30 days|||percentage of participants||95% Confidence Interval|Number
830534|NCT01238341|Secondary|Total Procedure Time||During procedure, up to 3 hours|||minutes|Participants|Full Range|Mean
830536|NCT01238341|Secondary|Successful Cannulation of the Duct of Intent|Deep cannulation of the bile/pancreatic duct was indicated in 12 of 13 ERCPs, one procedure was performed for stent removal only. This outcome was only relevant when deep cannulation was clinically indicated, therefore this outcome was determined out of 12 ERCPs.|During procedure, up to 3 hours|||ERCPs|Participants||Number
830537|NCT01238341|Primary|Papilla or Duct-enterostomy Was Reached||During procedure, up to 3 hours|||ERCPs|Participants||Number
830538|NCT01238471|Secondary|Safety of Propranolol Therapy in Premature Infants|Close monitoring for possible side effects of propranolol in premature infants|4 weeks of propranolol therapy in premature infants||||||
830539|NCT01238471|Primary|Regression of Retinopathy of Prematurity (ROP) in Premature Infants by Propranolol Therapy|"If ROP regresses without the need for treatment (laser and/or CRYO), this will be considered a favorable outcome. On the other hand, if ROP progresses to require treatment, it will be regarded as an unfavorable outcome.
Evidence for regression of ROP was observed by serial retinal examinations performed by ophthalmologists as well as by reduction for the need of invasive interventions such as laser photocoagulation of disease areas in the retina."|propranolol therapy for up 4 weeks|||cases|||Number
830540|NCT01238575|Secondary|ADHD Rating Scale - Total|The ADHD Rating Scale (ADHD-RS) is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder with established reliability, validity and sensitivity to change. The ADHD Rating Scale-IV is completed independently by the parent and scored by a clinician. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. Results from this rating scale alone should not be used to make a diagnosis. The total score can range from 0 to 54, with a higher score indicating greater severity.|Baseline|||units on a scale||95% Confidence Interval|Mean
830541|NCT01238575|Secondary|ADHD Rating Scale - Hyperactivity Subscale|The ADHD Rating Scale (ADHD-RS) is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder with established reliability, validity and sensitivity to change. The ADHD Rating Scale-IV is completed independently by the parent and scored by a clinician. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. Results from this rating scale alone should not be used to make a diagnosis. This subscale can range from 0 to 27 for scoring, with a higher score indicating greater severity.|Baseline|||units on a scale||95% Confidence Interval|Mean
830542|NCT01238575|Secondary|ADHD Rating Scale - Inattention Subscale|The ADHD Rating Scale (ADHD-RS) is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder with established reliability, validity and sensitivity to change. The ADHD Rating Scale-IV is completed independently by the parent and scored by a clinician. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. Results from this rating scale alone should not be used to make a diagnosis. This subscale can range from 0 to 27 for scoring, with a higher score indicating greater severity.|Baseline|||units on a scale||95% Confidence Interval|Mean
830543|NCT01238575|Secondary|Aberrant Behavior Checklist Inappropriate Speech Subscale|The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. This subscale's scores can range from 0 to 12.|Baseline|||units on a scale||95% Confidence Interval|Mean
830544|NCT01238575|Secondary|Aberrant Behavior Checklist Sterotypy Subscale|The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. This subscale's scores can range from 0 to 21.|Baseline|||units on a scale||95% Confidence Interval|Mean
830545|NCT01238575|Secondary|Aberrant Behavior Checklist Social Withdrawal Subscale|The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. This subscale's scores can range from 0 to 48.|Baseline|||units on a scale||95% Confidence Interval|Mean
830546|NCT01238575|Secondary|Aberrant Behavior Checklist Irritability Subscale|The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. Scores for this subscale can range from 0 to 45.|Baseline|||units on a scale||95% Confidence Interval|Mean
830547|NCT01238575|Secondary|Aberrant Behavior Checklist Hyperactivity Subscale|"The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech.
The 16-item Hyperactivity subscale covers over-activity (7 items), impulsiveness (2 items), inattention (3 items) and noncompliance (4 items). It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. The range of scores is 0 to 48."|Baseline|||units on a scale||95% Confidence Interval|Mean
830565|NCT01238640|Primary|AUC(0-∞)|AUC (0-∞) is the area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time. It is obtained from calculating AUC (0-t) plus AUC (t-∞).|10 hours post-dose|||hr*ng/mL||Standard Deviation|Mean
830548|NCT01238575|Secondary|ADHD Rating Scale - Hyperactivity Subscale|The ADHD Rating Scale (ADHD-RS) is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder with established reliability, validity and sensitivity to change. The ADHD Rating Scale-IV is completed independently by the parent and scored by a clinician. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. Results from this rating scale alone should not be used to make a diagnosis. This subscale can range from 0 to 27 for scoring,with a higher score indicating greater severity.|8 weeks|||units on a scale||95% Confidence Interval|Least Squares Mean
830549|NCT01238575|Secondary|ADHD Rating Scale - Inattention Subscale|The ADHD Rating Scale (ADHD-RS) is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder with established reliability, validity and sensitivity to change. The ADHD Rating Scale-IV is completed independently by the parent and scored by a clinician. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. Results from this rating scale alone should not be used to make a diagnosis. This subscale can range from 0 to 27 for scoring, with a higher score indicating greater severity.|8 weeks|||units on a scale||95% Confidence Interval|Least Squares Mean
830550|NCT01238575|Secondary|Aberrant Behavior Checklist Inappropriate Speech Subscale|The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. This subscale's scores can range from 0 to 12.|8 weeks|||units on a scale||95% Confidence Interval|Least Squares Mean
830551|NCT01238575|Secondary|Aberrant Behavior Checklist Sterotypy Subscale|The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. This subscale's scores can range from 0 to 21.|8 weeks|||units on a scale||95% Confidence Interval|Least Squares Mean
830552|NCT01238575|Secondary|Aberrant Behavior Checklist Social Withdrawal Subscale|The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. This subscale's scores can range from 0 to 48.|8 weeks|||units on a scale||95% Confidence Interval|Least Squares Mean
830553|NCT01238575|Secondary|Aberrant Behavior Checklist Irritability Subscale|The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. It is a 58 item checklist which takes about 10 – 15 minutes to complete. There are five subscales: a) Irritability and Agitation b) Lethargy and Social Withdrawal c) Stereotypic Behavior d) Hyperactivity and Noncompliance and e) Inappropriate Speech. The higher the number of items (score), the greater the amount of symptoms. Scores can range from 0 to 45.|8 weeks|||units on a scale||95% Confidence Interval|Least Squares Mean
830554|NCT01238575|Secondary|ADHD Rating Scale - Total|The ADHD Rating Scale (ADHD-RS) is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder with established reliability, validity and sensitivity to change. The ADHD Rating Scale-IV is completed independently by the parent and scored by a clinician. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. Results from this rating scale alone should not be used to make a diagnosis. The total score can range from 0 to 54, with a higher score indicating greater severity.|Week 8|||units on a scale||95% Confidence Interval|Least Squares Mean
830555|NCT01238575|Primary|Aberrant Behavior Checklist Hyperactivity Subscale|The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. The 16-item Hyperactivity subscale covers over-activity (7 items), impulsiveness (2 items), inattention (3 items) and noncompliance (4 items). It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. The range of scores is 0 to 48.|Week 8|||units on a scale||95% Confidence Interval|Least Squares Mean
830556|NCT01238588|Secondary|Hemodialysis Access Stenosis/Thrombosis||Baseline and 6 months|Data for this outcome measure was not collected from the medical record due to early termination of the study (per funding source).|||||
830557|NCT01238588|Secondary|Rate of Cardiovascular Events||Baseline and 6 months|Data for this outcome measure was not collected from the medical record due to early termination of the study (per funding source).|||||
830558|NCT01238588|Secondary|Hemoglobin Level||Baseline and 6 months|Clinical lab data for this outcome measure was not collected from the medical record (for research purpose) due to early termination of the study (per funding source)|||||
830559|NCT01238588|Secondary|Erythropoiesis Stimulating Agent (ESA) Dose Requirement||Baseline and 6 months|Data for this outcome measure was not collected from the medical record due to early termination of the study (per funding source).|||||
830560|NCT01238588|Secondary|Albumin Levels||Baseline and 6 months|Clinical lab data for this outcome measure was not collected from the medical record (for research purpose) due to early termination of the study (per funding source)|||||
830561|NCT01238588|Primary|Changes in Interleukin-6 (IL-6) Level||Baseline and 6 months|Blood samples were collected but the measurements were not done due to early study termination (per funding source).|||||
830562|NCT01238588|Primary|Changes in High Sensitivity C-Reactive Protein (Hs-CRP) Level||Baseline and 6 months|Blood samples were collected but the measurements were not done due to early study termination (per funding source).|||||
830566|NCT01238640|Primary|Area Under the Curve [AUC(0-t)]|Bioavailability within the Set Period [AUC(0-t)] is the area under the plasma concentration verses time curve from start of drug administration until the time of the last measurable plasma concentration, calculated as hour * nanograms (ng) per milliliter (mL).|During 10 hours post-dose|||hr*ng/mL||Standard Deviation|Mean
830567|NCT01238640|Primary|Maximum Observed Plasma Concentration (Cmax)|Cmax, which is the maximum observed plasma concentration after a dose is administered, measured in nanograms/milliliter (ng/mL)|During 10 hours post-dose|||ng/mL||Standard Deviation|Mean
830568|NCT01231373|Secondary|Change From Baseline at 8 Weeks Post-Treatment in IPR-V3 Score--Physician Photographic Review of Appearance|The Independent Photography Review--Visible Varicose Veins (IPR-V3) instrument is a 5-point scale used to assess the appearance of a patient's visible varicose veins. At baseline and Week 8, standardized digital photographs were taken of the medial view of the patient's target leg, from groin to ankle. An independent photography review panel, consisting of 3 trained, blinded clinicians, evaluated the appearance of the patient's visible varicose veins using the IPR-V3 instrument's 5-point scale (0-4, where 0=none and 4=very severe visible varicose veins).|8 weeks|||units on a scale||Standard Error|Least Squares Mean
830569|NCT01231373|Secondary|Change From Baseline to 8 Weeks in Appearance as Rated by Patient (PA-V3)|"The Patient Self-assessment of Visible Varicose Veins (PA-V3) instrument is a 5-point scale used by patients to evaluate the appearance of their visible varicose veins. On this single-item paper questionnaire, the instructions included a diagram fo the medial view of a leg with the area between the ankle and the groin circled. The patient was instructed to choose 1 of 5 response options that best described the appearance of the visible varicose veins of the leg that was treated in the study. The patient was instructed not to consider the appearance of the leg outside the circled area or of any spider veins. Possible responses ranged from Not at all noticeable (a score of 0) to Extremely noticeable (a score of 4)."|8 weeks|patients with a baseline and week 8 visit.||units on a scale||Standard Error|Mean
830570|NCT01231373|Primary|Change in Patient-Reported Symptoms of Varicose Veins (VVSymQ Score)|The 9 varicose vein symptoms were to be assessed and graded on a 6-point (i.e., 0-5) duration scale and an 11-point (i.e., 0-10) intensity scale, and the patient's level activity for that day was to be assessed and graded on the 6-point (i.e., 0-5) duration scale. The 9 varicose vein symptoms assessed using the e-diary were derived from the first question of the modified Venous Insufficiency Epidemiologic and Economic Study-Quality of Life/Symptoms (VEINES-QOL/Sym) instrument. The VVSymQ is a subset of 5 VEINES QOL/Sym items that have been determined in earlier studies to be most important to patients. The daily VVSymQ score is the sum of the duration scores for these 5 symptoms (scores range from 0 to 25). At Visit 2/baseline, Week 8, scores were calculated.|8 weeks|Number of subjects with a baseline value (VVSymQ) and value at the 8 week visit.||units on a scale||Standard Error|Least Squares Mean
830571|NCT01231399|Primary|Overall Survival|Estimated using the product-limit method of Kaplan and Meier. From the date treatment started until the date of death from any cause.|Up to 5 years.|||Months||95% Confidence Interval|Median
830572|NCT01231399|Primary|Progression-free Survival|Estimated using the product-limit method of Kaplan and Meier. From the date treatment started until the date of first documented progression or date of death from any cause, whichever came first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|up to 5 years|||Months||95% Confidence Interval|Median
830573|NCT01231399|Primary|Number of Subject With Overall Response|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Up to 5 years|||participants|||Number
830574|NCT01231399|Primary|Maximum Tolerated Dose (MTD) of Everolimus|The highest dose tested in which fewer than 33% of patients experience an attributable DLT to the study drug, when at least 6 patients are treated at that dose and are evaluable for toxicity. Toxicities will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) v4.0.|Course 1 (first 28 days)|All patients observed for 28 days while receiving a full course of therapy or who experienced a DLT. Patients withdrawing before completion of the first course, for reasons other than DLT, were replaced.||mg|||Number
830575|NCT01231464|Secondary|Mean Change From Baseline (Visit 2) to the End of Study (Visit 4/Early Withdrawal) in Severity of Overall Interference in Activities of Daily Living|The severity of overall interference in activities of daily living at baseline and the end of study was assessed by the investigator on the scale of 0=None, 1=Mild, 2=Moderate, 3=Severe. The mean change from baseline to the end of study in severity of overall interference in activities of daily living was calculated as the severity of overall interference in activities of daily living at Visit 4/Early Withdrawal minus severity of overall interference in activities of daily living at Visit 2.|Baseline through end of study (Day 1 through Day 15/Early Withdrawal)|FAS Population. Only participants for whom both baseline and post-baseline data were available were included in the analysis.||Points on a scale||Standard Error|Least Squares Mean
830576|NCT01231464|Secondary|Mean Change From Baseline (Visit 2) to the End of Study (Visit 4/Early Withdrawal) in Nasal Finding Score by Rhinoscopy|The nasal finding score by rhinoscopy (possible score of 0-12) is the sum of 4 individual investigator assessed scores for swelling of inferior nasal concha mucosa, color of inferior nasal concha mucosa, watery secretion volume, and description of rhinorrhea. The symptoms were assessed using a scale of 0=None, 1=Mild, 2=Moderate, 3=Severe. Mean change from baseline to the end of study in nasal finding score by rhinoscopy was calculated as the nasal finding score by rhinoscopy at Visit 4/Early Withdrawal minus the nasal final finding score by rhinoscopy at Visit 2.|Baseline through end of study (Day 1 through Day 15/Early Withdrawal)|FAS Population. Only participants for whom both baseline and post-baseline data were available were included in the analysis.||Points on a scale||Standard Error|Least Squares Mean
830587|NCT01231503|Secondary|Number of Subjects Reported With Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling. “Any” about a specific symptom is defined as incidence of this symptom, regardless of its intensity.|Within 7 days (Days 0-6) after Week 10 vaccination|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.||Subjects|||Number
830577|NCT01231464|Primary|Mean Change From Baseline Over the Entire Treatment Period in the Daily Reflective Total Nasal Symptom Score (rTNSS)|The Total Nasal Symptom Score (TNSS; possible score of 0-12) is the sum of 4 individual participant-assessed symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe. The rTNSS was performed in the morning (AM rTNSS) and evening (PM rTNSS) and assessed the participant's symptoms over the preceding 12 hours. The daily rTNSS is the average of the AM rTNSS and PM rTNSS assessments. Mean changes from baseline over the entire treatment period were calculated as treatment period rTNSS minus baseline rTNSS.|Baseline through entire treatment period (Day 1 through Day 14)|Full Analysis Set (FAS): all participants who were randomized and received at least one dose of study medication. Only participants for whom both baseline and post-baseline data were available were included in this analysis.||Points on a scale||Standard Error|Least Squares Mean
830578|NCT01231503|Secondary|Number of Subjects Reported With Solicited General Symptoms|Solicited general symptoms assessed include Drowsiness, Fever (temperature by axillary route ≥ 37.5°C), Irritability/Fussiness and Loss of appetite. “Any” about a specific symptom is defined as incidence of this symptom, regardless of its intensity or relationship to vaccination.|Within 7 days (Days 0-6) after Month 9 vaccination|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.||Subjects|||Number
830579|NCT01231503|Secondary|Number of Subjects Reported With Solicited General Symptoms|Solicited general symptoms assessed include Drowsiness, Fever (temperature by axillary route ≥ 37.5°C), Irritability/Fussiness and Loss of appetite. “Any” about a specific symptom is defined as incidence of this symptom, regardless of its intensity or relationship to vaccination. RTS,S Neo-10-14 Group, RTS,S 6-10-14 Group and Engerix-B Neo Group didn’t receive any vaccination at this time point|Within 7 days (Days 0-6) after Week 26 vaccination|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.||Subjects|||Number
830580|NCT01231503|Secondary|Number of Subjects Reported With Solicited General Symptoms|Solicited general symptoms assessed include Drowsiness, Fever (temperature by axillary route ≥ 37.5°C), Irritability/Fussiness and Loss of appetite. “Any” about a specific symptom is defined as incidence of this symptom, regardless of its intensity or relationship to vaccination.|Within 7 days (Days 0-6) after Week 14 vaccination|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.||Subjects|||Number
830581|NCT01231503|Secondary|Number of Subjects Reported With Solicited General Symptoms|Solicited general symptoms assessed include Drowsiness, Fever (temperature by axillary route ≥ 37.5°C), Irritability/Fussiness and Loss of appetite. “Any” about a specific symptom is defined as incidence of this symptom, regardless of its intensity or relationship to vaccination.|Within 7 days (Days 0-6) after Week 10 vaccination|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.||Subjects|||Number
830582|NCT01231503|Secondary|Number of Subjects Reported With Solicited General Symptoms|Solicited general symptoms assessed include Drowsiness, Fever (temperature by axillary route ≥ 37.5°C), Irritability/Fussiness and Loss of appetite. “Any” about a specific symptom is defined as incidence of this symptom, regardless of its intensity or relationship to vaccination.|Within 7 days (Days 0-6) after Week 6 vaccination|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.||Subjects|||Number
830583|NCT01231503|Secondary|Number of Subjects Reported With Solicited General Symptoms|Solicited general symptoms assessed include Drowsiness, Fever (temperature by axillary route ≥ 37.5°C), Irritability/Fussiness and Loss of appetite. “Any” about a specific symptom is defined as incidence of this symptom, regardless of its intensity or relationship to vaccination.|Within 7 days (Days 0-6) after Week 0 vaccination|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.||Subjects|||Number
830584|NCT01231503|Secondary|Number of Subjects Reported With Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling. “Any” about a specific symptom is defined as incidence of this symptom, regardless of its intensity.|Within 7 days (Days 0-6) after Month 9 vaccination|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.||Subjects|||Number
830585|NCT01231503|Secondary|Number of Subjects Reported With Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling. “Any” about a specific symptom is defined as incidence of this symptom, regardless of its intensity. RTS,S Neo-10-14 Group, RTS,S 6-10-14 Group and Engerix-B Neo Group didn’t receive vaccination at this time point.|Within 7 days (Days 0-6) after Week 26 vaccination|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.||Subjects|||Number
830586|NCT01231503|Secondary|Number of Subjects Reported With Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling. “Any” about a specific symptom is defined as incidence of this symptom, regardless of its intensity.|Within 7 days (Days 0-6) after Week 14 vaccination|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.||Subjects|||Number
830588|NCT01231503|Secondary|Number of Subjects Reported With Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling. “Any” about a specific symptom is defined as incidence of this symptom, regardless of its intensity.|Within 7 days (Days 0-6) after Week 6 vaccination|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.||Subjects|||Number
830589|NCT01231503|Secondary|Number of Subjects Reported With Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling. “Any” about a specific symptom is defined as incidence of this symptom, regardless of its intensity.|Within 7 days (Days 0-6) after Week 0 vaccination|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.||Subjects|||Number
830590|NCT01231503|Secondary|Concentrations of Antibodies Against Measles Antigens|The seropositivity cut-off for the assay was an anti-measles antibody (Anti-Measles Ab) concentration ≥ 150 milli-international units per millilitre (mIU/mL). Please note that this outcome measure was only assessed in subjects in the RTS,S 14-26-9M and Engerix-B Neo groups.|At Month 10|Analysis was done on the According-to-Protocol cohort for immunogenicity, that is, subjects from the Total Vaccinated cohort who received all vaccinations, complied to protocol procedures, and for whom results were available for the antibody concentrations/titers assessed in the specified outcome measure.||mIU/mL||95% Confidence Interval|Geometric Mean
830591|NCT01231503|Secondary|Concentrations of Antibodies Against Acellular B-pertussis (BPT)|Concentrations of anti-BPT antibodies were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs), in ELISA units per milliliter (EL.U/mL). The cut-off of the assay was the seropositivity cut-off value of greater than or equal to (≥) 15 EL.U/mL.|At Month 5|Analysis was done on the According-to-Protocol cohort for immunogenicity, that is, subjects from the Total Vaccinated cohort who received all vaccinations, complied to protocol procedures, and for whom results were available for the antibody concentrations/titers assessed in the specified outcome measure.||EL.U/mL||95% Confidence Interval|Geometric Mean
830592|NCT01231503|Secondary|Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Titers|Anti-Polio 1, 2 and 3 antibody titers were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seroprotection cut -off for the assay was ≥ 8. Results will be posted when they become available.|At Month 5||12/2016||||
830593|NCT01231503|Secondary|Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations|Anti-PRP antibody concentrations were calculated, expressed as geometric mean concentrations (GMCs), in microgram per milliliter (microg/mL), and tabulated. The seroprotection cut -off for the assay for the purpose of this endpoint was ≥ 0.15 microg/mL.|At Month 5|Analysis was done on the According-to-Protocol cohort for immunogenicity, that is, subjects from the Total Vaccinated cohort who received all vaccinations, complied to protocol procedures, and for whom results were available for the antibody concentrations/titers assessed in the specified outcome measure.||microg/mL||95% Confidence Interval|Geometric Mean
830594|NCT01231503|Secondary|Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations|Anti-D and anti-TT antibody concentrations were calculated, expressed as geometric mean concentrations (GMCs), in International units per milliliter (IU/mL), and tabulated. The seropositivity cut-off for the assay was ≥ 0.1 IU/mL.|At Month 5|Analysis was done on the According-to-Protocol cohort for immunogenicity, that is, subjects from the Total Vaccinated cohort who received all vaccinations, complied to protocol procedures, and for whom results were available for the antibody concentrations/titers assessed in the specified outcome measure.||IU/mL||95% Confidence Interval|Geometric Mean
830595|NCT01231503|Secondary|Anti-Hepatitis B Surface Antibody (Anti-HBs) Concentrations.|Concentrations, by enzyme-linked immunosorbent assay (ELISA), were presented as geometric mean concentrations (GMCs), and expressed in milli-international units per milliliter (mIU/mL). The seropositivity and seroprotection cut-offs were than or equal to (≥) 6.2 and 10 mIU/mL, respectively.|At Screening (SCR), at Month 5 (M5), at Month 7 (M7) and at Month 10 (M10), according to the vaccination scheduling|Analysis was done on the According-to-Protocol cohort for immunogenicity, that is, subjects from the Total Vaccinated cohort who received all vaccinations, complied to protocol procedures, and for whom results were available for the antibody concentrations/titers assessed in the specified outcome measure.||mIU/mL||95% Confidence Interval|Geometric Mean
830596|NCT01231503|Secondary|Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies)|Anti-CS antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean concentrations (GMCs) expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the endpoint was a GMC value greater than or equal to (≥) 0.5 EL.U/mL.|At Screening (SCR), at Month (M) 4, at M5, at M7 and/or at M10, according to the vaccination scheduling for the specific group assessed concerned group|Analysis was done on the According-to-Protocol cohort for immunogenicity, that is, subjects from the Total Vaccinated cohort who received all vaccinations, complied to protocol procedures, and for whom results were available for the antibody concentrations/titers assessed in the specified outcome measure.||EL.U/mL||95% Confidence Interval|Geometric Mean
830597|NCT01231503|Secondary|Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter|This outcome measure concerns haematological abnormalities, for the white blood cells (WBC) parameter. Subjects’ levels were assessed as either normal, Grade 1, Grade 2, Grade 3, Grade 4, Missing or Out of range (OOR). Normal WBC level was defined as > 2.5 x 10 exp 9 WBC per liter (Billions WBC/L). Grade 1 WBC level was defined as 2.0 to 2.5 Billions WBC/L. Grade 2 WBC level was defined as 1.5 to 1.999 Billions WBC/L. Grade 3 WBC level was defined as 1.0 to 1.499 Billions WBC/L. Grade 4 WBC level was defined as < 1.0 Billions WBC/L.|At screening (SCR), at Study Day 6 (D6), at 6 days post Study Week 6 (W6+6D), at 6 days post Study Week 10 (W10+6D), at 6 days post Study Week 14 (W14+6D), at Month 5 (M5), at Month 7 (M7) and at Month 10 (M10).|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.||Subjects|||Number
830598|NCT01231503|Secondary|Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter|This outcome measure concerns haematological abnormalities, for the platelets (PLA) parameter. Subjects’ levels were assessed as either normal, Grade (G) 1, G2, G3, G4, Missing or Out of range (OOR). Normal PLA level was defined as > 125 x 10 exp 9 PLA per liter (Billions PLA/L). Grade 1 PLA level was defined as 100 to 125 Billions PLA/L. Grade 2 PLA level was defined as 50 to 99 Billions PLA/L. Grade 3 PLA level was defined as 25 to 49 Billions PLA/L. Grade 4 PLA level was defined as < 25 Billions PLA/L.|At screening (SCR), at Study Day 6 (D6), at 6 days post Study Week 6 (W6+6D), at 6 days post Study Week 10 (W10+6D), at 6 days post Study Week 14 (W14+6D), at Month 5 (M5), at Month 7 (M7) and at Month 10 (M10).|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.||Subjects|||Number
830599|NCT01231503|Secondary|Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter|This outcome measure concerns haematological abnormalities, for the haemoglobin (HAE) parameter. Subjects’ levels were assessed as either normal, Grade (G) 1, G2, G3, G4, Missing or Out of range (OOR). Normal HAE level was defined as HAE > 13.0 and 10.5 grams per deciliter (g/dL) for subjects aged 1 to 21 and 22 to 35 days respectively. Grades were defined as follows: 1) In subjects aged 1 to 21 days: G1 = HAE as 12.0 to 13.0 g/dL, G2 = HAE as 10.0 to 11.9 g/dL, G3 = HAE as 9.0 to 9.9 g/dL, G4 = HAE < 9.0 g/dL; 2) In subjects aged 22 to 35 days: G1 = HAE as 9.5 to 10.5 g/dL, G2 = HAE as 8.0 to 9.4 g/dL, G3 = HAE as 7.0 to 7.9 g/dL, G4 = HAE < 7.0 g/dL; 3) In subjects aged 36 to 56 days: G1 = HAE as 8.5 to 9.4 g/dL, G2 = HAE as 7.0 to 8.4 g/dL, G3 = HAE as 6.0 to 6.9 g/dL, G4 = HAE < 6.0 g/dL; 4) In subjects aged ≥ 57 days: G1 = HAE as 10.0 to 10.9 g/dL, G2 = HAE as 9.0 to 9.9 g/dL, G3 = HAE as 7.0 to 8.9 g/dL, G4 = HAE < 7.0 g/dL.|At screening (SCR), at Study Day 6 (D6), at 6 days post Study Week 6 (W6+6D), at 6 days post Study Week 10 (W10+6D), at 6 days post Study Week 14 (W14+6D), at Month 5 (M5), at Month 7 (M7) and at Month 10 (M10).|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.||Subjects|||Number
830600|NCT01231503|Secondary|Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter|This outcome measure concerns biochemical abnormalities, for the creatinine (CREA) parameter. Subjects’ levels were assessed as either normal, Grade 1, Grade 2, Grade 3, Grade 4, Missing or Out of range (OOR). Normal CREA level was defined as CREA ≤ 106, 88 and 71 micromoles per liter (µmol/L) for subjects 1, 2 or ≥ 2 days of age, respectively. Grade 1 CREA level was defined as 1.1 to 1.3 times the upper limit of normal (ULN). Grade 2 CREA level was defined as 1.4 to 1.8 times the ULN. Grade 3 CREA level was defined as 1.9 to 3.4 times the ULN. Grade 4 CREA level was defined as ≥ 3.5 times the ULN.|At screening (SCR), at Study Day 6 (D6), at 6 days post Study Week 6 (W6+6D), at 6 days post Study Week 10 (W10+6D), at 6 days post Study Week 14 (W14+6D), at Month 5 (M5), at Month 7 (M7) and at Month 10 (M10).|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.||Subjects|||Number
830601|NCT01231503|Secondary|Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter|This outcome measure concerns biochemical abnormalities, for the alanine aminotransferase (ALT) parameter. Subjects’ levels were assessed as either normal, Grade 1, Grade 2, Grade 3, Grade 4, Missing or Out of range (OOR). Normal ALT level was defined as ALT< 60 International units per milliliter (IU/mL). Grade 1 ALT level was defined as 1.1 to 2.5 times the upper limit of normal (ULN). Grade 2 ALT level was defined as 2.6 to 5.0 times the ULN. Grade 3 ALT level was defined as 5.1 to 10.0 times the ULN. Grade 4 ALT level was defined as > 10.0 times the ULN.|At screening (SCR), at Study Day 6 (D6), at 6 days post Study Week 6 (W6+6D), at 6 days post Study Week 10 (W10+6D), at 6 days post Study Week 14 (W14+6D), at Month 5 (M5), at Month 7 (M7) and at Month 10 (M10).|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.||Subjects|||Number
830602|NCT01231503|Secondary|Number of Subjects Reported With Serious Adverse Events (SAEs)|An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or may evolve into one of the outcomes listed above. “Any” is defined an incidence of a SAE regardless of intensity/severity.|From study start at Month 0 up to Month 18 (corresponding data lock point =23 March 2015)|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment.||Subjects|||Number
830603|NCT01231503|Secondary|Number of Subjects Reported With Unsolicited Adverse Events (AEs)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. “Any” is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination. Please note that, for this outcome measure, analysis was performed only on subjects with at least one administered dose of RTS,S/AS01E and/or DTPwHepB/Hib for the Engerix-B Neo Group.|During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.||Subjects|||Number
830625|NCT01231607|Secondary|Serum Dihydrotestosterone (DHT) at Week 12, Week 24, and Follow-up (Week 26)|Serum concentrations of DHT were measured after 12 weeks and 24 weeks of study treatment and at follow-up (approximately 2 weeks after the last dose of study treatment).|Week 12, Week 24, and Week 26|ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at Baseline, Week 12, and Week 24 were assessed.||nanomoles per liter (nmol/L)||Standard Deviation|Mean
830604|NCT01231503|Primary|Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies)|Anti-CS antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean concentrations (GMCs) expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the endpoint was a GMC value greater than or equal to (≥) 0.5 EL.U/mL.|At 1 month (M) post Dose 3 of RTS,S/AS01E, e. a. M5 for RTS,S Neo-10-14, RTS,S 6-10-14 and Engerix-B Neo groups, M7 for RTS,S Neo-10-26, RTS,S 6-10-26, Engerix-B Neo/RTS,S 6-10-26, and RTS,S 10-14-26 groups), and M10 for RTS,S 14-26-9M Group|Analysis was done on the According-to-Protocol cohort for immunogenicity, that is, subjects from the Total Vaccinated cohort who received all vaccinations, complied to protocol procedures, and for whom results were available for the antibody concentrations/titers assessed in the specified outcome measure.||EL.U/mL||95% Confidence Interval|Geometric Mean
830605|NCT01231503|Primary|Number of Subjects Reported With Serious Adverse Events (SAEs)|An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or may evolve into one of the outcomes listed above. “Any” is defined an incidence of a SAE regardless of intensity/severity.|From study start at Month 0 up to Month 10.|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment.||Subjects|||Number
830606|NCT01231516|Secondary|DTG PK Parameters Including AUC(0-tau)|AUC is defined as the area under the DTG concentration-time curve as a measure of drug exposure over time. AUC(0-tau) is defined as the area under the plasma concentration-time curve from time zero to time tau over a dosing interval at steady state, where tau is the length of the dosing interval of DTG. AUC was assessed by population pharmacokinetic (PK) modeling using sparse PK samples which were collected as follows: one pre-dose sample and one post-dose sample at 1 to 3 hours/4 to 12 hours at Week 4, one pre-dose sample at Week 24, and one pre-dose sample and one post-dose sample at 1 to 3 hours/4 to 12 hours at Week 48.|Week 4, Week 24, and Week 48|PK Concentration Population: all participants who received DTG, underwent sparse PK sampling during the study, and provided evaluable DTG plasma concentration data. Only those participants available at the indicated time points were assessed.||Micrograms*hour per milliliter (µg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
830607|NCT01231516|Secondary|DTG PK Parameters Including Cmax, Cmin, C0, and C0_avg|The maximal concentration (Cmax), and the minimal concentration (Cmin) were assessed by population pharmacokinetic (PK) modeling using sparse PK samples which were collected as follows: one pre-dose sample and one post-dose sample at 1 to 3 hours/4 to 12 hours at Week 4, one pre-dose sample at Week 24, and one pre-dose sample and one post-dose sample at 1 to 3 hours/4 to 12 hours at Week 48. DTG predose concentration (C0) at Week 4, Week 24, and Week 48 as well as the average C0 (C0_avg) , Cmax and Cmin were estimated and reported here.|Week 4, Week 24, and Week 48|"PK Concentration Population: all participants who received DTG, underwent sparse PK sampling during the study, and provided evaluable DTG plasma concentration data. Only those participants available at the indicated time points were assessed. The number of participants assessed at each time point is indicated by n=X."||microgram/milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
830608|NCT01231516|Secondary|Number of Participants With the Indicated Post-Baseline Emergent Grade 1 to 4 Clinical Chemistry and Hematology Toxicities/Laboratory Adverse Events (AEs)|All Grade 1 to 4 post-Baseline-emergent chemistry toxicities included alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), asparate aminotransferase (AST), carbon dioxide (CO2) content/bicarbonate, cholesterol, creatine kinase (CK), creatinine, hyperglycemia, hyperkalemia, hypernatremia, hypoglycemia, hypokalemia, hyponatremia, low density lipoprotein (LDL) cholesterol calculation, lipase, total bilirubin, and triglycerides. All Grade 1 to 4 post-Baseline-emergent hematology toxities included hemoglobin, platelet count, total neutrophils, and white blood cell count. The Division of AIDS (DAIDS) defined toxicity grades as follows: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening; Grade 5, death. .|From Baseline until Week 48, including participants with post-treatment events occurring after Week 48 for participants not entering the post-Week 48 Open-Label phase of the study|Safety Population: all participants who received at least one dose of IP (i.e., DTG or RAL)||Participants|||Number
830609|NCT01231516|Secondary|Number of Participants With Indicated Post-Baseline HIV-associated Conditions, Excluding Recurrences, and Disease Progressions|Clinical disease progression (CDP) was assessed according to the Centers for Disease Control and Prevention (CDC) HIV-1 classification system. Category (CAT) A: one or more of the following conditions (CON), without any CON listed in Categories B and C: asymptomatic HIV infection, persistent generalized lymphadenopathy, acute (primary) HIV infection with accompanying illness or history of acute HIV infection. CAT B: symptomatic CON that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or that are considered by physicians to have a clinical course or to require management that is complicated by HIV infection; and not included among CON listed in clinical CAT C. CAT C: the clinical CON listed in the AIDS surveillance case definition. Indicators of CDP were defined as: CDC CAT A at Baseline (BS) to a CDC CAT C event (EV); CDC CAT B at BS to a CDC CAT C EV; CDC CAT C at BS to a new CDC CAT C EV; or CDC CAT A, B, or C at BS to death.|From Baseline (Day 1) until Week 48|mITT-E Population||Participants|||Number
830610|NCT01231516|Other Pre-specified|Absolute Values and Change From Baseline in Cluster of Differentiation 8+ (CD8+) Cell Counts at Weeks 4, 8, 12, 16, 24, 32, 40, and 48|The absolute value data for CD8+ cell count (cells per millimeters cubed [mm^3]) were only reported on a per-participant basis and were not summarized.|Baseline; Weeks 4, 8, 12, 16, 24, 32, 40, and 48|mITT-E Population|||||
830611|NCT01231516|Secondary|Absolute Values and Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at Weeks 4, 8, 12, 16, 24, 32, 40, and 48|The absolute value for CD4+ cell count (cells per millimeters cubed [mm^3]) was assessed at Baseline (BL), Week 4, Week 8, Week 12, Week 16, Week 24, Week 32, Week 40 and Week 48. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; Weeks 4, 8, 12, 16, 24, 32, 40, and 48|"mITT-E Population. Only those participants available at the indicated time points were assessed. The number of participants assessed at each visit is indicated by n=X, X."||cells/mm^3||Inter-Quartile Range|Median
830697|NCT01232504|Secondary|Graft Versus Host Disease (aGVHD) Related Mortality|Graft versus host disease (aGVHD) related mortality after a median follow-up of 600 days .|3-1099 days|The number of intention-to-treat patients is 206. The IFD related mortality analysis is based on intention-to-treat (ITT) patients .||percentage of participants|||Number
830612|NCT01231516|Secondary|Number of Participants With Plasma HIV-1 RNA <400 c/mL at Week 24 and Week 48|"The number of participants with Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) <400 c/mL at the visit of interest was assessed using the Missing, Switch or Discontinuation = Failure (MSDF), as codified by the Food and Drug Administration (FDA) snapshot algorithm. This algorithm treated all participants without HIV-1 RNA at the visit of interest as nonresponders, as well as participants who switched their concomitant ART prior to the visit of interest as follows: background ART substitutions non-permitted per protocol (one background ART substitution was permitted for safety or tolerability); background ART substitutions permitted per protocol unless the decision to switch was documented as being before or at the first on-treatment visit where HIV-1 RNA was assessed. Otherwise, virologic success or failure was determined by the last available HIV-1 RNA measurment (within window) for the timepoint of interest while the participant was on-treatment."|Week 24, Week 48|mITT-E Population||Participants|||Number
830613|NCT01231516|Secondary|Number of Participants With Plasma HIV-1 RNA <50 c/mL at Week 24|"The number of participants with Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) <50 c/mL at Week 24 was assessed using the Missing, Switch or Discontinuation = Failure (MSDF), as codified by the Food and Drug Administration (FDA) snapshot algorithm. This algorithm treated all participants without HIV-1 RNA at Week 24 as nonresponders, as well as participants who switched their concomitant ART prior to Week 24 as follows: background ART substitutions non-permitted per protocol (one background ART substitution was permitted for safety or tolerability); background ART substitutions permitted per protocol unless the decision to switch was documented as being before or at the first on-treatment visit where HIV-1 RNA was assessed. Otherwise, virologic success or failure was determined by the last available HIV-1 RNA measurement through Week 24 (within window) while the participant was on-treatment. The result below corresponds to the Week 24 interim analysis."|Week 24|mITT-E Population||Participants|||Number
830614|NCT01231516|Secondary|Number of Participants (Par.) With Detectable Virus That Has Genotypic or Phenotypic Evidence of Treatment-emergent INI Resistance at Time of Protocol Defined Virology Failure (PDVF)|For par. meeting one of the criteria for PDVF, plasma samples collected at the time point of virologic failure and Baseline were tested to evaluate any potential genotypic and/or phenotypic evolution of resistance. PDVF was defined as (A) virologic non-response: a decrease in plasma HIV-1 RNA of <1 log10 copies/mL by Week 16, with subsequent confirmation, unless plasma HIV-1 RNA is <400 copies/mL; confirmed plasma HIV-1 RNA levels >=400 copies/mL on or after Week 24 or (B) virologic rebound: confirmed rebound in plasma HIV-1 RNA levels to >=400 copies/mL after prior confirmed suppression to <400 copies/mL; confirmed plasma HIV-1 RNA levels >1 log10 copies/mL above the nadir value, where nadir is >=400 copies/mL.Treatment-emergent IN mutations are those detected at the time of PDVF but not at Baseline.|Baseline until PDVF up to Week 48|mITT-E Population||Participants|||Number
830615|NCT01231516|Primary|Percentage of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) at Week 48|"The percentage of participants with Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) <50 c/mL at Week 48 was assessed using the Missing, Switch or Discontinuation = Failure (MSDF), as codified by the Food and Drug Administration (FDA) snapshot algorithm. This algorithm treated all participants without HIV-1 RNA at Week 48 as nonresponders, as well as participants who switched their concomitant ART prior to Week 48 as follows: background ART substitutions non-permitted per protocol (one background ART substitution was permitted for safety or tolerability); background ART substitutions permitted per protocol unless the decision to switch was documented as being before or at the first on-treatment visit where HIV-1 RNA was assessed. Otherwise, virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment in the randomized phase of the study."|Week 48|Modified Intent-To-Treat Exposed (mITT-E) Population: all randomized participants who received at least one dose of IP excluding four participants at one site, which was closed due to Good Clinical Practice (GCP) non-compliance issues in another ViiV sponsored trial.||Percentage of participants|||Number
830616|NCT01231581|Secondary|Number of Participants With Change From Baseline Increase to Grade 3/Grade 4 in Lab Hematology Test Measurements|A grading (severity) scale is provided for each laboratory toxicity. Grade refers to the severity of the toxicity. The CTCAE version 3.0 displays Grades 1 through 5, with unique clinical descriptions of the severity for each toxicity based on the general guideline: Grade 1, mild toxicity; Grade 2, moderate toxicity; Grade 3, severe toxicity; Grade 4, life-threatening or disabling toxicity; Grade 5, death related to toxicity.|From the start of the first dose of study treatment until 28 days following discontinuation of the study treatment or until the data cutoff of 17-April-2012 (up to 17 months)|Safety Population. Only those par. with laboratory values for worst-case on therapy were analyzed. The same par. were not necessarily analyzed for each laboratory parameter; thus, the number of par. analyzed reflects all par. in the Safety Population. The number of par. analyzed for a particular parameter is included in the parameter title.||participants|||Number
830617|NCT01231581|Secondary|Number of Participants (Par.) With a Worst-case Change to Grade 3 or Grade 4 From Baseline Grade in Chemistry Parameters|A grading (severity) scale is provided for each laboratory toxicity. Grade refers to the severity of the toxicity. The Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 displays Grades 1 through 5 based on the general guideline: Grade 1, mild toxicity; Grade 2, moderate toxicity; Grade 3, severe toxicity; Grade 4, life-threatening or disabling toxicity; Grade 5, death related to toxicity.|From the start of the first dose of study treatment until 28 days following discontinuation of the study treatment or until the data cutoff of 17-April-2012 (up to 17 months)|Safety Population. Only those par. with laboratory values for worst-case on therapy were analyzed. The same par. were not necessarily analyzed for each laboratory parameter; thus, the number of par. analyzed reflects all par. in the Safety Population. The number of par. analyzed for a particular parameter is included in the parameter title.||participants|||Number
830626|NCT01231607|Secondary|Serum Concentration of Dutasteride at Week 12, Week 24, and Follow-up (Week 26)|Serum concentrations of dutasteride were measured after 12 weeks and 24 weeks of study treatment and at follow-up (approximately 2 weeks after the last dose of study treatment).|Week 12, Week 24, and Week 26|ITT Population. All participants for whom data were collected at Baseline, Week 12, and Week 24 were assessed.||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
830698|NCT01232504|Secondary|Relapse Related Mortality|Relapse related mortality after a median follow-up of 600 days.|3～1099 days|The number of intention-to-treat patients is 206. The IFD related mortality analysis is based on intention-to-treat (ITT) patients .||percentage of participants|||Number
830618|NCT01231581|Secondary|Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Per protocol other events were considered SAEs like symptomatic left ventricular ejection fraction (LVEF) decreases or cases of central serous retinopathy (CSR) or retinal vein occlusion (RVO). AE and SAE data were collected from the start of the first dose of study treatment and continued until 28 days following discontinuation of the study treatment or death. Refer to the general AE/SAE module for a complete list of AEs and SAEs.|From the start of the first dose of study treatment until 28 days following discontinuation of the study treatment or until the data cutoff of 15-March-2013 (up to 21 months)|Safety Population: all participants who were randomized and took at least one dose of study medication. This population was based on the actual treatment received, if it differed from that to which the participant was randomized.||participants|||Number
830619|NCT01231581|Secondary|Investigator-Assessed Duration of Response|Duration of response is defined, for the subset of participants with a CR or PR, as the time from the first documented evidence of CR or PR until the first documented disease progression or death due to any cause. CR is defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g., percent change from baseline). PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start).|From the first documented CR or PR until disease progression or death due to any cause or until the data cutoff of 17-April-2012 (up to 13 months)|MD Population. Duration of response was assessed for only those participants with a CR or PR.||Weeks||95% Confidence Interval|Median
830620|NCT01231581|Secondary|Number of Participants With an Investigator-assessed Best Response, With or Without Confirmation, of Complete Response (CR) or Partial Response (PR)|CR is defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g., percent change from baseline). CR and PR were evaluated by the Investigator using standard criteria (RECIST version 1.1). Confirmation of response was not required.|From randomization until disease progression or death due to any cause or until the data cutoff of 17-April-2012 (up to 15 months)|Measurable Disease (MD) Population: all randomized participants regardless of whether or not treatment was administered who had measurable disease at baseline||participants|||Number
830621|NCT01231581|Secondary|Progression-free Survival (PFS) as Assessed by the Investigator|PFS is defined as the time from randomization until the earliest date of radiological PD or death due to any cause. PD was based on radiographic or photographic evidence, and assessments were made by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 millimeters (mm). PD was also based on unequivocal progression of existing non-target lesions. If the participant received subsequent anti-cancer therapy prior to the date of documented progression or death, or did not have a documented date of progression or death, PFS was censored at the last adequate assessment.|From randomization until disease progression (PD) or death due to any cause or until the data cutoff of 17-April-2012 (up to 15 months)|ITT Population||weeks||95% Confidence Interval|Median
830622|NCT01231581|Primary|Overall Survival|Overall survival is defined as the time from randomization until death due to any cause. For the analysis of overall survival, the last date of known contact was used for those participants who were not dead at the time of analysis; such participants were considered censored.|From randomization until death due to any cause or until the data cutoff of 15-March-2013 (up to 24 months)|Intent-to-Treat (ITT) Population: all randomized participants regardless of whether or not treatment was administered||months||95% Confidence Interval|Median
830623|NCT01231607|Secondary|Change From Baseline in Total Hair Growth Satisfaction Scale (HGSS) Scores at Weeks 12 and 24|Participant satisfaction with hair appearance/growth was assessed by 5 questions (each scored on a 7-point scale: How satisfied do you feel about: [1] The overall appearance of your hair; [2] The appearance of the thinning area[s] [TAs] on your head; [3] The amount of scalp that can be seen in the TAs; [4] The amount of hair in the TAs; [5] The growth of hair in the TAs): -3, Very dissatisfied (DS); -2, DS; -1, Somewhat DS; 0, Neutral (neither satisfied nor DS); 1, Somewhat satisfied (SA); 2, SA; 3, Very SA. The scores for the 5 questions were summed to obtain the HGSS total score (-15 to 15).|Baseline, Week 12, and Week 24|ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at Week 12 and Week 24 were assessed.||scores on a scale||Standard Error|Least Squares Mean
830624|NCT01231607|Secondary|Change From Baseline in Hair Growth Index (HGI) Scores at Weeks 12 and 24|"Participant-perceived change in HG was assessed by 3 questions (each scored on a 7-point scale) on a health outcome questionnaire: Since the start of treatment, when I look at my thinning area, I can see..., Since the start of treatment, my hair now covers…, and Since the start of treatment, the appearance (thickness/quality/amount) of the thinning area on my head is… -3, Much less; -2, Moderately less; -1, Slightly less; 0, The same amount; 1, Slightly more; 2, Moderately more; 3, Much more scalp. The scores for the 3 questions were summed to obtain the HGI total score (-9 to 9)."|Baseline, Week 12, and Week 24|ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at Week 12 and Week 24 were assessed.||scores on a scale||Standard Error|Least Squares Mean
830645|NCT01231750|Primary|Time-to-onset of Angina or Angina Equivalent Symptoms|Onset of angina or angina-equivalent symptoms was assessed from beginning of exercise.|Application was 45 minutes prior to exercise|Data collected are no longer accessible.|||||
830627|NCT01231607|Secondary|Number of Participants With the Indicated Change From Baseline (BL) in the Stage (S) of Androgenic Alopecia (AGA) According to the Norwood-Hamilton Scale at Week 24|"The investigator/designee assessed the stage (Stage I to Stage VII) of AGA (i.e., male pattern baldness [MPB]) by utilizing the Norwood-Hamilton scale, used to measure the progression of MPB. Stage VII indicates worse balding than stage I. Assessment was made by direct visual examination (aided by pictures) of the participant at Baseline and Week 24 (W24). v, vertex; most of the hair loss (commonly seen with advancing age) is on the vertex. a, type a variant; major features are (1) the entire anterior hairline border recedes in unison; (2) there is no simultaneous balding of the vertex."|Baseline and Week 24|ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at both Baseline and Week 24 were assessed. The number of participants analyzed reflects the sum of the participants with the three BL stages.||participants|||Number
830628|NCT01231607|Secondary|Number of Participants With the Indicated Change From Baseline (BL) in the Stage (S) of Androgenic Alopecia (AGA) According to the Norwood-Hamilton Scale at Week 12 (W12)|"The investigator/designee assessed the stage (Stage I to Stage VII) of AGA (i.e., male pattern baldness [MPB]) by utilizing the Norwood-Hamilton scale, used to measure the progression of MPB. Stage VII indicates worse balding than stage I. Assessment was made by direct visual examination (aided by pictures) of the participant at Baseline and Week 12 (W12). v, vertex; most of the hair loss (commonly seen with advancing age) is on the vertex. a, type a variant; major features are (1) the entire anterior hairline border recedes in unison; (2) there is no simultaneous balding of the vertex."|Baseline and Week 12|ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at both Baseline and Week 12 were assessed. The number of participants analyzed reflects the sum of the participants with the three BL stages.||participants|||Number
830629|NCT01231607|Secondary|Change From Baseline in Investigator Photographic Assessment Questionnaire (IPAQ) Scores Assessed at Week 24 for Vertex and Frontal Views Separately|The IPAQ was completed by the Investigator or designee by comparing the global photographs obtained at Baseline with those obtained at Week 12. This assessment was made separately based on the global photography of the vertex and frontal views. The change from Baseline in hair growth was assessed using the following 7-point scale: –3 = greatly decreased, –2 = moderately decreased, –1 = slightly decreased, 0 = no change, +1 = slightly increased, +2 = moderately increased, +3 = greatly increased.|Baseline and Week 24|ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at both Baseline and Week 24 were assessed.||scores on a scale||Standard Error|Least Squares Mean
830630|NCT01231607|Secondary|Change From Baseline in Investigator Photographic Assessment Questionnaire (IPAQ) Scores Assessed at Week 12 for Vertex and Frontal Views Separately|The IPAQ was completed by the Investigator or designee by comparing the global photographs obtained at Baseline with those obtained at Week 12. This assessment was made separately based on the global photography of the vertex and frontal views. The change from Baseline in hair growth was assessed using the following 7-point scale: –3 = greatly decreased, –2 = moderately decreased, –1 = slightly decreased, 0 = no change, +1 = slightly increased, +2 = moderately increased, +3 = greatly increased.|Baseline and Week 12|ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at both Baseline and Week 12 were assessed.||scores on a scale||Standard Error|Least Squares Mean
830631|NCT01231607|Secondary|Global Assessment of Improvement From Baseline to Week 24 Assessed for Vertex and Frontal Views Separately|A central panel of 3 dermatologists independently assessed change in hair growth from Baseline to Week 24 using a 7-point scale: greatly decreased (-3), moderately decreased (-2), slightly decreased (-1), no change (0), slightly increased (1), moderately increased (2), and greatly increased (3). The median score, across the 3 panel members, is summarized. This assessment was performed by comparing the global photographs obtained at Baseline with those subsequently obtained at Week 24. This assessment was made separately based on the global photography of the vertex and frontal views.|Baseline and Week 24|ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at both Baseline and Week 24 were assessed.||scores on a scale||Standard Error|Least Squares Mean
830632|NCT01231607|Secondary|Change From Baseline in Terminal Hair Count Within a 1.13 cm (0.44 Inch) Diameter Circle at the Vertex at Week 12 and Week 24, as Assessed by MT|The THC (thick, long, and dark hair) was the sum of all nonvellus hairs (>=60 μm in width; thick and noticeable hair) within a target 1.13 cm (0.44 inch) diameter circle at the vertex (crown, topmost part of the head). A cosmetic ink dot was placed by tattoo at BL so that the same area could be identified at BL and post-BL. If the ink dot faded, it was re-done in exactly the same location to ensure visibility for subsequent photographs. For the MT, hair was clipped before each photograph; HC was based on hair follicles in the photographs. Change from BL=Week 12/Week 24 value minus BL value.|Baseline, Week 12, and Week 24|ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at both Baseline, Week 12, and Week 24 were assessed.||Hair count||Standard Error|Least Squares Mean
830633|NCT01231607|Secondary|Change From Baseline in Terminal Hair Count (THC) Within a 2.54 cm (1 Inch) Diameter Circle at the Vertex at Week 12 and Week 24, as Assessed by MT|The THC (thick, long, and dark hair) was the sum of all nonvellus hairs (>=60 μm in width; thick and noticeable hair) within a target 2.54 cm (1 inch) diameter circle at the vertex (crown, topmost part of the head). A cosmetic ink dot was placed by tattoo at BL so that the same area could be identified at BL and post-BL. If the ink dot faded, it was re-done in exactly the same location to ensure visibility for subsequent photographs. For the MT, hair was clipped before each photograph; HC was based on the hair follicles in the photographs. Change from BL=Week 12/Week 24 value minus BL value.|Baseline, Week 12, and Week 24|ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at both Baseline, Week 12, and Week 24 were assessed.||Hair count||Standard Error|Least Squares Mean
830646|NCT01231750|Primary|Time-to-onset of 1mm ST Segment Depression|Continuous ECG was recorded during exercise. ECG was reviewed by a board-certified cardiologist.|Application was 45 minutes prior to exercise|Data collected are no longer accessible.|||||
830647|NCT01231750|Primary|Symptom-limited Exercise Duration as an Indicator of Exercise Capacity|Subjects walked on the treadmill as long as they could tolerate, symptom-limited.|Application was 45 minutes prior to exercise|Data collected are no longer accessible.|||||
830634|NCT01231607|Secondary|Change From Baseline in Target Area Hair Width Within a 1.13 cm (0.44 Inch) Diameter Circle at the Vertex at Week 12 and Week 24, as Assessed by MT|The target area hair width was the sum of all nonvellus hairs (>=30 µm in width; thick and noticeable hair) within a target 1.13 cm (0.44 inch) diameter circle at the vertex (crown, topmost part of the head). For the MT, hair was clipped before each photograph. A cosmetic ink dot was placed by tattoo at Baseline so that the same area could be identified at Baseline and post-Baseline. If the ink dot faded, it was re-done in exactly the same location to ensure it was visible for subsequent photographs. Change from Baseline was calculated as the Week 12 or Week 24 value minus the Baseline value.|Baseline, Week 12, and Week 24|ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at Baseline, Week 12, and Week 24 were assessed.||millimeters||Standard Error|Least Squares Mean
830635|NCT01231607|Secondary|Change From Baseline in Target Area Hair Width Within a 2.54 cm (1 Inch) Diameter Circle at the Vertex at Week 12 and Week 24, as Assessed by MT|The target area hair width was the sum of all nonvellus hairs (>=30 µm in width; thick and noticeable hair) within a target 2.54 cm (1 inch) diameter circle at the vertex (crown, topmost part of the head). For the MT, hair was clipped before each photograph. A cosmetic ink dot was placed by tattoo at Baseline so that the same area could be identified at Baseline and post-Baseline. If the ink dot faded, it was re-done in exactly the same location to ensure it was visible for subsequent photographs. Change from Baseline was calculated as the Week 12 or Week 24 value minus the Baseline value.|Baseline, Week 12, and Week 24|ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at Baseline, Week 12, and Week 24 were assessed.||millimeters||Standard Error|Least Squares Mean
830636|NCT01231607|Secondary|Change From Baseline in Target Area Hair Count Within a 1.13 cm (0.44 Inch) Diameter Circle at the Vertex, as Assessed by MT at Week 12|The primary target area HC was based on the nonvellus hair (>=30 micrometers [μm] in width; thick and noticeable hair) count within a target 1.13 cm (0.44 inch) diameter circle at the vertex (crown, topmost part of the head). A cosmetic ink dot was placed by tattoo at BL so that the same area could be identified at BL and post-BL. If the ink dot faded, it was re-done in exactly the same location to ensure visibility for subsequent photographs. For the MT, hair was clipped before each photograph; HC was based on hair follicles in the photographs. Change from BL=Week 12 value minus the BL value.|Baseline and Week 12|ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at both Baseline and Week 12 were assessed.||Hair count||Standard Error|Least Squares Mean
830637|NCT01231607|Secondary|Change From Baseline in Target Area Hair Count Within a 2.54 cm (1 Inch) Diameter Circle at the Vertex at Week 12 as Assessed by MT|The primary target area HC was based on the nonvellus hair (>=30 micrometers [μm] in width; thick and noticeable hair) count within a target 2.54 cm (1 inch) diameter circle at the vertex (crown, topmost part of the head). A cosmetic ink dot was placed by tattoo at BL so that the same area could be identified at BL and post-BL. If the ink dot faded, it was re-done in exactly the same location to ensure visibility for subsequent photographs. For the MT, hair was clipped before each photograph; HC was based on hair follicles in the photographs. Change from BL=Week 12 value minus the BL value.|Baseline and Week 12|ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at both Baseline and Week 12 were assessed.||Hair count||Standard Error|Least Squares Mean
830638|NCT01231607|Secondary|Change From Baseline in Target Area Hair Count Within a 1.13 cm (0.44 Inch) Diameter Circle at the Vertex at Week 24, as Assessed by MT|The primary target area HC was based on the nonvellus hair (>=30 micrometers [μm] in width; thick and noticeable hair) count within a target 1.13 cm (0.44 inch) diameter circle at the vertex (crown, topmost part of the head). A cosmetic ink dot was placed by tattoo at BL so that the same area could be identified at BL and post-BL. If the ink dot faded, it was re-done in exactly the same location to ensure visibility for subsequent photographs. For the MT, hair was clipped before each photograph; HC was based on hair follicles in the photographs. Change from BL=Week 24 value minus the BL value.|Baseline and Week 24|ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at both Baseline and Week 24 were assessed.||Hair count||Standard Error|Least Squares Mean
830639|NCT01231607|Primary|Change From Baseline (BL) in Target Area Hair Count (HC) Within a 2.54 Centimeter (cm) (1 Inch) Diameter Circle at the Vertex at Week 24, as Assessed by Macrophotographic Technique (MT)|The primary target area HC was based on the nonvellus hair (>=30 micrometers [μm] in width; thick and noticeable hair) count within a target 2.54 cm (1 inch) diameter circle at the vertex (crown, topmost part of the head). A cosmetic ink dot was placed by tattoo at BL so that the same area could be identified at BL and post-BL. If the ink dot faded, it was re-done in exactly the same location to ensure visibility for subsequent photographs. For the MT, hair was clipped before each photograph; HC was based on hair follicles in the photographs. Change from BL=Week 24 value minus the BL value.|Baseline and Week 24|Intent-to-Treat (ITT) Population: all randomized participants regardless of whether or not treatment was administered. Calculation was based on the last observation carried forward (LOCF) imputation method for missing data. All participants for whom data were collected at both Baseline and Week 24 were assessed.||Hair count||Standard Error|Least Squares Mean
830640|NCT01231646|Primary|Levels of Folate Receptor Autoantibodies|ELISA assays using immobilized folate receptor protein were performed to determine the titers of immunoglobulin G, immunoglobulin M, and combined immunoglobulin G and immunoglobulin M to folate receptor in serum samples collected from both groups of women.|On the same day after informed consent was obtained|||ug/mL||Standard Deviation|Mean
830641|NCT01231750|Primary|Severity of Angina Was Measured.|Severity of angina was measured using numerical score 1 to 10, where 10 is the worst intensity and 1 is the least.|Application was 45 minutes prior to exercise||||||
830642|NCT01231750|Primary|Magnitude of Reversible Perfusion Defect in SPECT With Wall Motion Assessment (Phase 2)|Phase 2 of the study involving nuclear imaging was not done because the study was stopped early for lack of enrollment.|Phase 2 was not done.||||||
830643|NCT01231750|Primary|Maximal Estimated Workload (in METS)|Maximal estimated workload (in METS) was measured during exercise tolerance test (ETT).|Application was 45 minutes prior to exercise|Data collected are no longer accessible.|||||
830644|NCT01231750|Primary|Maximal ST Depression|Exercise ECG data was reviewed by a board certified cardiologist to assess maximal ST depression.|Application was 45 minutes prior to exercise|Data collected are no longer accessible.|||||
830650|NCT01231841|Primary|Patients Treated With Rabbit Antithymocyte Globulin (r-ATG/Thymoglobulin) and Cyclosporine (CsA) Achieving at Least a Partial Remission (PR) at 6 Months|Patients will be classified as responders if they have transfusion independence and meet two of the following three criteria: ANC greater than 500/mm3; platelet count greater than 20,000/mm3; and reticulocyte count greater than 40,000/mm3. Transfusion independence is defined as no need for transfusions for one month prior to response assessment.|At 6 months|||participants|||Number
830651|NCT01231984|Secondary|Number of Serious, Unexplained Hyperglycemic Events, Reported as Number of Events by Needle.|"Subjects were asked to record hyperglycemic events in his/her diary anytime his/her blood glucose (BG) was above 400mg/dL, or s/he required medical attention for treatment for hyperglycemia.
Hyperglycemia was defined as serious when the subject required the assistance of another person to be treated, or when the hyperglycemic event met the per-protocol definition of a Serious Adverse Event. An unexplained episode was defined as one with no known cause (for example, the subject missed an insulin dose). Subjects were asked to record these events in a diary."|During Study Period 1 (12 weeks) and Study Period 2 (12 weeks)|Two hundred seventy-four subjects were randomized into the study. Data from all subjects randomized were included in the analysis of subjects with serious, unexplained hyperglycemic events.||Adverse Events|||Number
830652|NCT01231984|Primary|Glycemic Control as Measured by HbA1c (4 mm vs. 12.7 mm)|"Subjects’ glycemic control was assessed by comparing hemoglobin A1c (HbA1c) levels measured at the end of each 12 week Study Period (e.g., at Visit 5 or Visit 7) to the HbA1c measured at the start of that Study Period, i.e. the baseline (Visit 3) for Period 1 and the Period 1/2 crossover (Visit 5) for Period 2.
Analysis included only subjects with HbA1C values at baseline (Visit 3) and at the end of Study Period 1 (Visit 5) and end of Period 2 (Visit 7)."|Over each 12 week study period|115 subjects completed all main study visits. Two subjects were excluded from the 4 vs. 12.7 primary analysis due to protocol deviations. The total population size evaluated for this analysis is therefore 113.||HbA1c (%)||Standard Deviation|Mean
830653|NCT01231984|Secondary|Number of Serious, Unexplained Hypoglycemic Events, Reported as Number of Events by Needle.|"Subjects were asked to record hypoglycemic events in his/her diary anytime his/her blood glucose (BG) was below 50mg/dL, s/he had signs/symptoms of hypoglycemia, or s/he required medical attention for treatment.
Hypoglycemia was defined as serious when the subject required the assistance of another person to be treated, or when the hypoglycemic event met the per-protocol definition of a Serious Adverse Event. An unexplained episode was defined as one with no known cause (for example, the subject skipped a meal or exercised vigorously)."|During Study Period 1 (12 weeks) and Study Period 2 (12 weeks)|Two hundred seventy-four subjects were randomized into the study. Data from all subjects randomized were included in the analysis of subjects with serious, unexplained hypoglycemic events.||Adverse Events|||Number
830654|NCT01231984|Secondary|Injection Pain Scores (4 mm vs. 12 mm)|"At the end of second study period, subjects were asked to rate the level of pain experienced with study period 2 needle compared to the pen needle used in study period 1, using a 150 mm Visual Analog Scale (VAS). The VAS is a measure of the pain perceived with the needle they are using at that point in the study relative to the needle they used the previous period. The VAS is anchored at the center (0mm) with as painful and at each extreme with much less painful (-75mm) and much more painful (+75mm); therefore a negative pain rating means the period 2 needle was perceived as less painful than the period 1 needle."|At the end of Study Period 2|115 subjects in the 4mm vs. 12 mm study arm completed all main study visits. One of the subjects was excluded from all primary and secondary analyses due to protocol deviations.||mm||Standard Error|Mean
830655|NCT01231984|Secondary|Injection Pain Scores (4 mm vs. 8 mm)|"At the end of second study period, subjects were asked to rate the level of pain experienced with study period 2 needle compared to the pen needle used in study period 1, using a 150 mm Visual Analog Scale (VAS). The VAS is a measure of the pain perceived with the needle they are using at that point in the study relative to the needle they used in Period 1. The VAS is anchored at the center (0mm) with as painful and at each extreme with much less painful (-75mm) and much more painful (+75mm); therefore a pain rating < 0 indicates that the Period 2 needle was perceived as less painful than the Period 1 needle."|At the end of Study Period 2|115 subjects in the 4mm vs. 8 mm study arm completed all main study visits. Two of the 115 subjects were excluded from all primary and secondary analyses due to protocol deviations. The total number of subjects analyzed for perceived pain for this study was therefore 113.||mm||Standard Error|Mean
830656|NCT01231984|Secondary|Glycemic Control as Measured by HbA1c, in High Dose Insulin (at Least One Dose of ≥ 40 Units) Users|Glycemic control was assessed as by difference between the subjects' HbA1c (%) at baseline (randomization, Visit 3) and at the end of each 12 week study period,in the same manner as for the primary outcome measures. The 95% confidence interval for the mean difference in HbA1c values between the 4mm PN and the longer PN will be estimated based on general linear models adjusting for baseline HbA1c.|Subjects were randomly assigned to use the BD Ultra-Fine™ 4mm pen needle for one - 12 week study period and either the BD Ultra-Fine™ 8mm pen needle or the BD Ultra-Fine™ 12.7mm pen needle for one - 12 week study period.|Of the 226 subjects who were considered for the Primary analysis, 107 subjects had at least one dose of insulin that was at least 40 units. The glycemic control of this sub-group of subjects was analyzed as in the Primary Analysis.The same analysis was performed for the high insulin dose subjects, with the two longer PN study arms pooled together.||HbA1C (%)||Standard Deviation|Mean
830657|NCT01231984|Primary|Glycemic Control as Measured by HbA1c (4 mm vs. 8 mm)|"Subjects’ glycemic control was assessed by comparing hemoglobin A1c (HbA1c) levels measured at the end of each 12 week Study Period (e.g., at Visit 5 or Visit 7) to the HbA1c measured at the start of that Study Period, i.e. the baseline (Visit 3) for Period 1 and the Period 1/2 crossover (Visit 5) for Period 2.
Analysis included only subjects with HbA1C values at baseline (Visit 3) and at the end of Study Period 1 (Visit 5) and end of Period 2 (Visit 7)."|Over each 12 week study period|115 subjects completed all main study visits. Two subjects were excluded from the 4 vs. 8 primary analysis due to protocol deviations. The total population size evaluated for the primary objective (4 vs. 8) is therefore 113.||HbA1c (%)||Standard Deviation|Mean
830699|NCT01232504|Secondary|IFD Related Mortality|IFD-related mortalities after a median follow-up of 600 days.|3-1099 days|The number of intention-to-treat patients is 206. The IFD related mortality analysis is based on intention-to-treat (ITT) patients .||percentage of participants||95% Confidence Interval|Number
840388|NCT01328756|Primary|Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Last On-treatment Assessment (LOTA)||Baseline (Week 0), LOTA (Week 104)|Safety population with participants evaluable for this outcome||mmHg||Standard Deviation|Mean
830658|NCT01232127|Secondary|Number of Participants With Abnormalities in Laboratory Test Results|PreRX=pretreatment; ULN=upper limit of normal. Neutrophils, (absolute), low (10*3 c/uL): <0.85*PreRx, if PreRx <1.5; <1.5 if PreRx ≥1.5. Alanine aminotransferase, high (U/L): >1.25*PreRx if PreRx >ULN; >1.25*ULN if PreRx ≤ULN. Bilirubin, direct (mg/dL), high: >1.1*ULN if PreRx ≤ULN;> 1.1*ULN if PreRx is missing; >1.25*PreRx if PreRx >ULN. Bilirubin, total (mg/dL), high: >1.1*ULN if PreRx ≤ULN;> 1.1*ULN if PreRx is missing; >1.25*PreRx if PreRx >ULN.|Days 11, 18, and 25 (end of study) and at study discharge for those who discontinued prematurely.|Participants who received study drug and were evaluable.||Participants|||Number
830659|NCT01232127|Secondary|Number of Participants With Abnormalities in Electrocardiogram (ECG) Findings|ECG findings include heart rate, ECG intervals (including PR, QRS, QT, and corrections to QT using both Bazett’s and Fridericia’s formulae), and Investigator-identified ECG abnormalities.|Days 1 and 25 (end of study) and at study discharge for those who discontinued prematurely.|Participants who received study drug and were evaluable.||Participants|||Number
830660|NCT01232127|Primary|Area Under the Plasma Concentration-time Curve in 1 Dosing Interval (Time 0 to 24 Hours Postdose) (AUC[TAU]) for Atazanavir and Ritonavir||Days 10, 11, 17, 18, 24, and 25 (end of study) and at study discharge for those who discontinued prematurely.|Participants who received study drug and had adequate PK profiles.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
830661|NCT01232127|Primary|Time of Maximum Observed Plasma Concentration (Tmax) for Atazanavir and Ritonavir||Days 10, 11, 17, 18, 24, and 25 (end of study) and at study discharge for those who discontinued prematurely.|Participants who received study drug and had adequate PK profiles.||Hours||Full Range|Median
830662|NCT01232127|Primary|Maximum Observed Plasma Concentration (Cmax) and Trough Observed Plasma Concentration (Ctrough) for Atazanavir and Ritonavir||Days 10, 11, 17, 18, 24, and 25 (end of study) and at study discharge for those who discontinued prematurely.|Participants who received study drug and had adequate PK profiles.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
830663|NCT01232127|Secondary|Number of Participants With Abnormalities in Vital Signs|Vital signs include temperature, respiratory rate, seated blood pressure, and heart rate.|Days 1, 11, 18, and 25 (end of study) and at study discharge for those who discontinued prematurely.|Participants who received study drug and were evaluable.||Participants|||Number
830664|NCT01232127|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, AES, and AEs of Clinical Interest|An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|Days 1 through 25 (end of study), continuously, and at study discharge for those who discontinued prematurely.|Participants who received study drug and were evaluable.||Participants|||Number
830665|NCT01232205|Primary|Preeclampsia|Preeclampsia was defined as gestational hypertension (systolic pressure ≥140 mmHg or diastolic blood pressure ≥ 90 mmHg [Korotkoff V] on ≥ 2 occasions after 20 weeks gestation) with proteinuria (> 0.3 g/day). Severe preeclampsia was defined by the presence of >1 of the following: (a) severe gestational hypertension (systolic pressure ≥160 mmHg or diastolic blood pressure ≥110 mmHg on 2 occasions after gestational week 20), or (b) severe proteinuria (≥5g protein in a 24-h urine specimen or ≥3 g in 2 random urine samples collected ≥4 h apart)|9 months|||participants|||Number
830666|NCT01232205|Secondary|Cell-free mRNA|Secondary outcome were level of mRNA level of angiogenic factors (vascular endothelial growth factor receptor-1 (VEGFR-1), placental growth factor (PlGF) and endoglin(ENG)); antioxidant status (FRAP, heme oksigenase-1 (HO-1) and superoxide-dismutase (SOD))|40 weeks||||||
830667|NCT01232205|Primary|Preeclampsia|Preeclampsia was defined as gestational hypertension (systolic pressure ≥140 mmHg or diastolic blood pressure ≥ 90 mmHg [Korotkoff V] on ≥ 2 occasions after 20 weeks gestation) with proteinuria (> 0.3 g/day). Severe preeclampsia was defined by the presence of >1 of the following: (a) severe gestational hypertension (systolic pressure ≥160 mmHg or diastolic blood pressure ≥110 mmHg on 2 occasions after gestational week 20), or (b) severe proteinuria (≥5g protein in a 24-h urine specimen or ≥3 g in 2 random urine samples collected ≥4 h apart)|40 weeks||||||
830668|NCT01232283|Secondary|Number of Participants With Psoriasis Flare or Rebound in the Placebo Controlled Phase|Psoriasis flare was defined as a sudden intensification of psoriasis requiring medical intervention, or a diagnosis of new generalized erythrodermic, inflammatory, or pustular psoriasis. Rebound is defined as a severe and sudden worsening of disease that occurs after treatment has been discontinued. Note categories below. [1] Psoriasis adverse events (ie, preferred term as Guttate psoriasis, Psoriasis, Pustular psoriasis) started on or after the first dose date and on or before the last dose date within the phase. [2] Psoriasis adverse events (ie, preferred term as Guttate psoriasis, Psoriasis, Pustular psoriasis, Rebound psoriasis) started after the last dose date for participants who discontinued within the phase. [3] PASI >= 125% of baseline score at any visit after the last dose date for participants who discontinued within the phase and were not included in [1] and/or [2].|Week 0 to Week 16|Safety population, included all participants who were randomized and received at least one dose of IP. Participants with a PASI ≥ 125% of Baseline score after last dose who did not have psoriasis rebound captured as a Treatment Emergent Adverse Event.||participants|||Number
830669|NCT01232283|Secondary|Number of Participants With Adverse Events (AE) in the Placebo Controlled Phase|An AE was any noxious, unintended, or untoward medical occurrence, that may appear or worsen in a participant during the course of study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) was considered an AE. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above. An AE is a treatment emergent AE if the AE start date is on or after the date of the first dose of study drug and no later than 28 days after the last dose.|Baseline to Week 16|Safety population consisted of all participants who were randomized and received at least one dose of Investigational Product (IP)||participants|||Number
830670|NCT01232283|Secondary|Time to Loss of Effect (Loss of 50% Improvement in PASI Score Obtained at Week 32 Compared to Baseline) During the Randomized Treatment Withdrawal Phase|Time to loss was the time between the re-randomization date and the date of the first assessment with loss of 50% PASI improvement (event), or the time between the re-randomization date and the date of the last PASI assessment in the randomized withdrawal phase prior to addition of topical/phototherapy or other effective psoriasis therapies, or resumption of apremilast 30 mg BID, or discontinuation, or Week 52 if no loss (censored), whichever was earlier|Weeks 32 to Week 52|Analysis population consisted of participants who were re-randomized to placebo or Apremilast 30mg BID at Week 32.||Weeks||95% Confidence Interval|Median
830671|NCT01232283|Secondary|Percentage of Participants Who Achieved Both a 75% Improvement (Response) in the PASI and sPGA Score of Clear (0) or Almost Clear (1) With at Least 2 Points Reduction at Week 16 From Baseline|"PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. See Outcome measure #1 for further description.
sPGA is a 5-point scale ranging from 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), to 4 (severe), incorporating an assessment of the severity of the three primary signs of the disease: erythema, scaling and plaque elevation. See Outcome Measure #2 for further description."|Baseline to Week 16|The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward imputation was used.||percentage of participants|||Number
830672|NCT01232283|Secondary|Change From Baseline in the Mental Component Summary (MSC) Score of the Medical Outcome Study Short Form 36-item (SF-36) Health Survey Version 2.0 at Week 16|"The SF-36 was a 36-item general health instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS).
Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value."|Baseline to Week 16|The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward imputation was used. Participants with a baseline value and at least 1 postbaseline value are included.||units on a scale||Standard Error|Least Squares Mean
830673|NCT01232283|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16|DLQI is a simple, compact, and practical questionnaire for use in a dermatology clinical setting to assess limitations related to the impact of skin disease. The instrument contains ten items dealing with the participant’s skin. With the exception of Item Number 7, the participant responds on a four-point scale, ranging from “Very Much” (score 3) to “Not at All” or “Not relevant” (score 0). Item Number 7 is a multi-part item, the first part of which ascertains whether the participant’s skin prevented them from working or studying (Yes or No, scores 3 or 0 respectively), and if “No,” then the subject is asked how much of a problem the skin has been at work or study over the past week, with response alternatives being “A lot,” “A little,” or “Not at all” (scores 2, 1, or 0 respectively). The DLQI total score was derived by summing all item scores, which has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best.|Baseline and Week 16|The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward imputation was used. Participants with a baseline value and at least 1 postbaseline value are included||units on a scale||Standard Error|Least Squares Mean
830674|NCT01232283|Secondary|Change From Baseline in Pruritus Visual Analog Scale (VAS) Score at Week 16|The Pruritus Visual Analog Scores (VAS) were used to measure the amount of itching and discomfort a participant experiences. Participant's Assessment of Pruritus (Itch) asked: On average, how much itch have you had because of your condition in the past week? All VAS values range from 0 to 100. Higher scores correspond to more severe symptom or disease. Change from baseline was calculated for the VAS scale, where change = visit value − baseline value.|Baseline and Week 16|The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward imputation was used. Participants with a baseline value and at least 1 postbaseline value are included.||units on a scale||Standard Error|Least Squares Mean
830675|NCT01232283|Secondary|Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score (PASI-50) at Week 16 From Baseline|PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The PASI score was set to missing if any severity score or degree of involvement is missing.|Baseline and Week 16|The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward imputation was used.||Percentage of Participants|||Number
830700|NCT01232504|Primary|Incidences of Invasive Fungal Diseases (IFD)|The incidence of proven and probable Invasive fungal diseases (IFD) within 100 days post transplantation|100 day post transplant|The number of intention-to-treat patients is 206. The incidence of invasive fungal infection analysis within 100 day is based on intention-to-treat (ITT)patients .||percentage of partipants|||Number
830676|NCT01232283|Secondary|Percent Change From Baseline in the Psoriasis Area Severity Index (PASI) Score at Week 16|Psoriasis Area Severity Index (PASI) scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. These values for each anatomic region are summed to yield the PASI score. The PASI score was set to missing if any severity score or degree of involvement is missing.|Baseline and Week 16|FAS consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward (LOCF) imputation was used. Participants with a baseline value and at least 1 postbaseline value are included.||percent change||Standard Error|Least Squares Mean
830677|NCT01232283|Secondary|Percent Change From Baseline in the Affected Body Surface Area (BSA) at Week 16|"BSA was a measurement of involved skin. The overall BSA affected by psoriasis was estimated based on the palm area of the participant’s hand (entire palmar surface or “handprint” including the fingers), which equates to approximately 1% of total body surface area.
BSA percent change from baseline (Visit 2 Week 0) was determined at each visit of the study, which is calculated as 100*(visit BSA – baseline BSA) / baseline BSA (%)."|Baseline and Week 16|The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Participants with a baseline value and at least 1 postbaseline value were included. Last observation carried forward imputation was used.||percent change||Standard Error|Least Squares Mean
830678|NCT01232283|Secondary|Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of Clear (0) or Almost Clear (1) With at Least 2 Points Reduction From Baseline|The sPGA was a 5-point scale ranging from 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), to 4 (severe), incorporating an assessment of the severity of the three primary signs of the disease: erythema, scaling and plaque elevation. When making the assessment of overall severity, the Investigator must have factored in areas that have already been cleared (ie, have scores of 0) and not just evaluate remaining lesions for severity, ie, the severity of each sign was averaged across all areas of involvement, including cleared lesions. In the event of different severities across disease signs, the sign that is the predominant feature of the disease should be used to help determine the sPGA score.|Baseline to Week 16|The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward imputation was used.||percentage of participants|||Number
830679|NCT01232283|Primary|Percentage of Participants Who Achieved at Least a 75% Improvement (Response) in the Psoriasis Area Severity Index (PASI-75) at Week 16 From Baseline|PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at week 16. The improvement in PASI score was used as a measure of efficacy. The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The PASI score was set to missing if any severity score or degree of involvement is missing.|Baseline to Week 16|The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward (LOCF) imputation was used. .||percentage of participants|||Number
830680|NCT01232296|Secondary|Pharmacokinetic (PK) Parameter of AUCtau Following a Single Dose of TKI258|The mean AUC from time zero to the last measurable concentration sampling time (t last) (mass x time x volume-1)|Week 1 day 1, week 4 day 5|The Full-PK analysis set: all patients who were selected for full PK sampling and provided at least one evaluable PK concentration profile||(ng.h/mL)||Standard Deviation|Mean
830681|NCT01232296|Secondary|Pharmacokinetic (PK) Parameter of Tmax Following a Single Dose of TKI258|Tmax will be evaluated after a single dose of TKI258 following a 5 days on/2 days off dosing schedule. Tmax is the time to to reach maximum (peak) plasma, blood, serum, or other body fluid drug concentration after a single dose administration (time)|Week 1 day 1, week 4 day 5|The Full-PK analysis set: all patients who were selected for full PK sampling and provided at least one evaluable PK concentration profile||hours||Full Range|Median
830682|NCT01232296|Secondary|Pharmacokinetic (PK) Parameter of Cmax Following a Single Dose of TKI258|Cmax will be evaluated after a single dose of TKI258 following a 5 days on/2 days off dosing schedule. Cmax is the maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after a single dose administration (mass x volume - 1).|Week 1 day 1, week 4 day 5|The Full-PK analysis set: all patients who were selected for full PK sampling and provided at least one evaluable PK concentration profile||(ng/mL)||Standard Deviation|Mean
830683|NCT01232296|Secondary|Time to Definitive Deterioration in ECOG Performance Status (PS)|Time to definitive deterioration on ECOG PS scale (by at least one point) was defined as the time from the date of randomization to the date of definitive deterioration of the ECOG PS by at least one category of the score from baseline or to the date of death whichever occurred earlier. 0 is Fully active, able to carry on all pre-disease performance without restriction, 1 is Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g. light housework, office work and 2 is ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.|Every 6 weeks from date of randomization until the patient has progressed, or the patient can no longer be followed, or at least 130 deaths have been observed in the study, whichever came first|The Full Analysis Set (FAS): all patients to whom study treatment had been assigned by randomization. According to the intent to treat principle, patients were analyzed according to the treatment (and strata) they were assigned to during the randomization procedure. Only Total number of definitive deterioration events included in the analysis||Weeks||95% Confidence Interval|Median
830684|NCT01232296|Secondary|Disease Control Rate (Tumor Assessment)|Disease Control Rate (DCR) is defined as the proportion of patients whose best overall response is either complete response [CR], partial response [PR] or stable disease [SD] according to RECIST 1.1.|Every 6 weeks from date of randomization until the patient has progressed, or the patient can no longer be followed, or at least 130 deaths have been observed in the study, whichever came first.|The Full Analysis Set (FAS) comprises of all patients to whom study treatment had been assigned by randomization. According to the intent to treat principle, patients were analyzed according to the treatment (and strata) they were assigned to during the randomization procedure.||Participants|||Number
830685|NCT01232296|Secondary|Time to Tumor Progression (Tumor Assessment)|Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1). For target lesions, disease progression mean at least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, disease progression refers to unequivocal progression of existing non-target lesions. In addition, the appearance of new lesions is always considered as disease progression.|Every 6 weeks from date of randomization until the patient has progressed, or the patient can no longer be followed, or at least 130 deaths have been observed in the study, whichever came first.|The Full Analysis Set (FAS) comprises of all patients to whom study treatment had been assigned by randomization. According to the intent to treat principle, patients were analyzed according to the treatment (and strata) they were assigned to during the randomization procedure.||Weeks||95% Confidence Interval|Median
830686|NCT01232296|Primary|Overall Survival - Overall Survival|The overall survival (OS), defined as the time from date of randomization to the date of death from any cause. If a patient was not known to have died at the date of analysis cut-off, OS was censored at the last date of contact. Survival information was collected every 6 wks until at least 130 deaths have been observed|Every 6 weeks from date of randomization until the patient has progressed, or the patient can no longer be followed, or at least 130 deaths have been observed in the study, whichever came first.|The Full Analysis Set (FAS) comprises of all patients to whom study treatment had been assigned by randomization. According to the intent to treat principle, patients were analyzed according to the treatment (and strata) they were assigned to during the randomization procedure.||Weeks||95% Confidence Interval|Median
830687|NCT01232465|Primary|Pregnancy|detemining whether the sperm sample (tested for DNA integrity) used to insemenate IVF retrieved eggs, results in a live birth|9 months|||participants|||Number
830688|NCT01232491|Secondary|Rate of Nocturnal Treatment Emergent Hypoglycaemic Episodes|Corresponds to rate of treatment emergent hypoglycaemic episodes per patient exposure year. A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and no later than 1 day after the last day of randomised treatment. A hypoglycaemic episode with time of onset between 00:01 and 05:59 a.m. (both included) was considered nocturnal. Severe, if assistance was required to actively administer carbohydrate, glucagons or other resuscitative actions.|Week 0 to Week 26|Safety analysis set includes all subjects who received at least one dose of insulin detemir.||rate per year of patient exposure|||Number
830689|NCT01232491|Secondary|Rate of All Treatment Emergent Hypoglycaemic Episodes|Corresponds to rate of treatment emergent hypoglycaemic episodes per patient exposure year. A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and no later than 1 day after the last day of randomised treatment. Severe, if assistance was required to actively administer carbohydrate, glucagons or other resuscitative actions.|Week 0 to Week 26|Safety analysis set includes all subjects who received at least one dose of insulin detemir.||rate per year of patient exposure|||Number
830690|NCT01232491|Secondary|Rate of Treatment Emergent Adverse Events (TEAEs)|Corresponds to rate of adverse events (AEs) per 100 patient years of exposure. Mild AEs: no or transient symptoms, no interference with subject's daily activities. Moderate AEs: marked symptoms, moderate interference with subject's daily activities. Severe AEs: considerable interference with subject's daily activities, unacceptable. Serious AEs: AEs that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalization, persistent/significant disability/incapacity/congenital anomaly/birth defect.|Week 0 to Week 26|Safety analysis set includes all subjects who received at least one dose of insulin detemir.||rate per 100 years of patient exposure|||Number
830691|NCT01232491|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|Estimated mean change from baseline in FPG after 26 weeks of treatment.|Week 0, Week 26|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF).||mmol/L||Standard Error|Least Squares Mean
830692|NCT01232491|Secondary|Change From Baseline in Glycosylated Haemoglobin (HbA1c)|Estimated mean change from baseline in HbA1c after 26 weeks of treatment.|Week 0, Week 26|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF).||percentage of glycosylated haemoglobin||Standard Error|Least Squares Mean
830693|NCT01232491|Secondary|Change From Baseline in Body Mass Index (BMI)|Estimated mean change from baseline in BMI after 26 weeks of treatment.|Week 0, Week 26|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF).||kg/m^2||Standard Error|Least Squares Mean
830694|NCT01232491|Primary|Change From Baseline in Body Weight|Estimated mean change from baseline in body weight after 26 weeks of treatment.|Week 0, Week 26|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF).||kg||Standard Error|Least Squares Mean
830695|NCT01232504|Secondary|Infection Related Mortality|Infection related mortality after a median follow-up of 600 days.|3～1099 days)|The number of intention-to-treat patients is 206. The IFD related mortality analysis is based on intention-to-treat (ITT) patients .||percentage of participants|||Number
830696|NCT01232504|Secondary|Hemorrhage Related Mortality|Hemorrhage related mortality after a median follow-up of 600 days|3-1099 days|The number of intention-to-treat patients is 206. The IFD related mortality analysis is based on intention-to-treat (ITT) patients .||percentage of participants|||Number
830701|NCT01232504|Secondary|Incidence of Ⅱ- Ⅳ Acute Graft Versus Host Disease (aGVHD)|Incidence of Ⅱ- Ⅳacute graft versus host disease (aGVHD) within 100 days after allogeneic stem cell transplantation (Allo-HSCT).The severity of acute GVHD in the three main target organs (skin, liver, gastrointestinal tract) was assigned stage 1 to 4 based on accepted criteria (Consensus Conference on Acute GVHD Grading).|100 days post transplant|The number of intention-to-treat patients is 206. The incidence of aGVHD analysis is based on intention-to-treat (ITT) patients .||percentage of partipants||95% Confidence Interval|Number
830702|NCT01232504|Secondary|Transplant Related Mortality|Transplant related mortality within 100 days after Allogeneic Stem Cell Transplantation (Allo-HSCT).|100 days post transplant|The number of intention-to-treat patients is 206. The transplant related mortality analysis within 100 day is based on intention-to-treat (ITT) patients .||percentage of participants||95% Confidence Interval|Number
830703|NCT01232504|Secondary|Hematological Engraftment|The median time of neutrophil and platelet recovery .|100 days post transplant|The number of intention-to-treat patients is 206. The hematological engraftment analysis within 100 day is based on intention-to-treat (ITT)patients .||days||Full Range|Median
830704|NCT01232569|Secondary|Change From Baseline in Hemoglobin at Week 24||Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.||g/L||Standard Deviation|Mean
830705|NCT01232569|Secondary|Change From Baseline in the Physical and Mental Component Scores of the Short Form 36 (SF-36) Health Survey at Week 24|The SF-36 Health Survey uses patient-reported symptoms on 8 subscales to assess health-related quality of life (HRQoL). The Physical Component Summary (PCS) score summarizes the subscales Physical Functioning, Role−Physical, Bodily Pain, and General Health. The Mental Component Summary (MCS) score summarizes the subscales Vitality, Social Functioning, Role−Emotional, and Mental Health. Each score was scaled from 0 to 100 with a higher score indicating better HRQoL. A positive change score indicates an improvement in HRQoL.|Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.||Units on a scale||Standard Deviation|Mean
830706|NCT01232569|Secondary|Change From Baseline in the Van Der Heijde Modified Sharp Radiographic Score at Week 24|The degree of joint damage was assessed using the van der Heijde modified total Sharp score (mTSS). The methodology quantifies the extent of bone erosions for 44 joints and joint space narrowing (JSN) for 42 joints, with higher scores representing greater damage. The independent read of X-ray images was performed by 2 primary readers. In case of discrepancy between the 2 primary readers, an adjudicator was involved. The mTSS can range from 0 to 448 with a higher score indicating more joint damage. A negative change score indicates improvement.|Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.||Units on a scale||Standard Deviation|Mean
830707|NCT01232569|Secondary|Percentage of Patients With Good, Moderate, or no European League Against Rheumatism (EULAR) Responses at Week 24|Change of the Disease Activity Score 28 score from baseline was used to determine EULAR responses of good, moderate, or no response. For a post-baseline score ≤ 3.2, a change from baseline of < -1.2 was a good response, < -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-baseline score > 3.2 to ≤ 5.1, a change from baseline of < -0.6 was a moderate response and ≥ -0.6 was no response. For a post-baseline score > 5.1, a change from baseline < -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-baseline scores > 3.2.|Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.||Percentage of patients|||Number
830708|NCT01232569|Secondary|Percentage of Patients With a DAS28 Score < 2.6 (DAS28 Remission) at Week 24|The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient’s global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A negative change score indicates improvement.|Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.||Percentage of patients||95% Confidence Interval|Number
830709|NCT01232569|Secondary|Percentage of Patients With a DAS28 Score ≤ 3.2 (DAS28 Low Disease Activity) at Week 24|The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient’s global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A negative change score indicates improvement.|Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.||Percentage of patients||95% Confidence Interval|Number
830710|NCT01232569|Secondary|Change From Baseline in Disease Activity Score 28 (DAS28) at Week 24|The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient’s global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A negative change score indicates improvement.|Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.||Units on a scale||Standard Deviation|Mean
830711|NCT01232569|Secondary|Percentage of Patients With an Improvement of ≥ 0.3 Units From Baseline in the HAQ-DI Score at Week 24|The HAQ-DI is a questionnaire specific for rheumatoid arthritis and consists of 20 questions referring to 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Patients completed the questionnaire by answering the 20 questions on a scale of 0 (without difficulty) to 3 (unable to do). The total score ranges from 0 (no disability) to 3 (completely disabled). A negative change score indicates improvement.|Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.||Percentage of patients||95% Confidence Interval|Number
830712|NCT01232569|Secondary|Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24|The HAQ-DI is a questionnaire specific for rheumatoid arthritis and consists of 20 questions referring to 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Patients completed the questionnaire by answering the 20 questions on a scale of 0 (without difficulty) to 3 (unable to do). The total score ranges from 0 (no disability) to 3 (completely disabled). A negative change score indicates improvement.|Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.||Units on a scale||Standard Deviation|Mean
830713|NCT01232569|Secondary|Change From Baseline in the Patient’s Pain Visual Analog Score|Patients assessed their pain in the previous 24 hours on a visual analog scale, where the extreme left end of the line represented “no pain” and the extreme right end represented “unbearable pain”. Scores ranged from 0 to 100 with a higher score indicating more pain. A negative change score indicated less pain.|Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.||Units on a scale||Standard Deviation|Mean
830714|NCT01232569|Secondary|Change From Baseline in the Patient’s and the Physician’s Global Assessment of Disease Activity Visual Analog (VAS) Score|Patients and physicians assessed the patient’s disease activity in the previous 24 hours on a 100 mm visual analog scale, where the extreme left end of the line represented “no disease activity” (symptom-free and no arthritis symptoms) and the extreme right end represented “maximum disease activity”. Scores ranged from 0 to 100 with a higher score indicating more disease activity. A negative change score indicated less disease activity.|Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.||Units on a scale||Standard Deviation|Mean
830715|NCT01232569|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate at Week 24||Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.||mm/hr||Standard Deviation|Mean
830716|NCT01232569|Secondary|Change From Baseline in C-reactive Protein at Week 24||Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.||mg/dL||Standard Deviation|Mean
830717|NCT01232569|Secondary|Change From Baseline in Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Week 24|Joints (28 joints) will be assessed and classified as swollen/not swollen and tender/not tender by pressure and joint manipulation on physical examination.|Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.||Joint count||Standard Deviation|Mean
830718|NCT01232569|Secondary|Time to Onset of ACR20, ACR50, and ACR70 Responses|Time to first ACR response was calculated as the number of days between the date of the first ACR response minus the date of the first dose of study drug. Median days are reported.|Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.||Days||95% Confidence Interval|Median
830719|NCT01232569|Secondary|Percentage of Patients With ACR50 and ACR70 Responses at Week 24|A patient had an ACR50 response if there was at least a 50% improvement in the ACR scores. A patient had an ACR70 response if there was at least a 70% improvement in the ACR scores.|Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.||Percentage of patients||95% Confidence Interval|Number
830720|NCT01232569|Primary|Percentage of Patients With an American College of Rheumatology 20 (ACR20) Response at Week 24|A patient had an ACR20 response if there was at least a 20% improvement, ie, reduction from baseline, in tender and swollen joint counts (28 assessed joints) and in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, left end=no disease activity [symptom-free and no arthritis symptoms], right end=maximum disease activity; patient assessment of pain in previous 24 hours on a VAS (left end=no pain and right end=unbearable pain); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and acute-phase reactant (either C-reactive protein or erythrocyte sedimentation rate).|Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.||Percentage of patients||95% Confidence Interval|Number
830721|NCT01232790|Secondary|Brief Psychiatric Rating Scale (BPRS)Total Score|"Brief Psychiatric Rating Scale (BPRS) utilized before and after treatment. BPRS total score is a total of the 18 item scores with a range of 18-126. It is used to measure schizophrenia symptoms and to assess change in them over time. There are 18 symptom sub scores. Each symptom is rated 1-7 (not present to extremely severe) and then all items are summed for the total score. Higher scores indicate more severe symptoms.
The BPRS is the gold-standard overall measure of schizophrenia symptoms which will be utilized to demonstrate that the intervention does not cause worsening of the illness symptoms apart from the usual fluctuations of the natural course."|Change from PreScreening at End of Trial|Analyses only used matched cases and does not include participants with incomplete data.||units on a scale||Standard Deviation|Mean
830722|NCT01232790|Secondary|Brief Psychiatric Rating Scale (BPRS)Total Score|"Brief Psychiatric Rating Scale (BPRS) utilized before and after treatment. BPRS total score is a total of the 18 item scores with a range of 18-126. It is used to measure schizophrenia symptoms and to assess change in them over time. There are 18 symptom sub scores. Each symptom is rated 1-7 (not present to extremely severe) and then all items are summed for the total score. Higher scores indicate more severe symptoms.
The BPRS is the gold-standard overall measure of schizophrenia symptoms which will be utilized to demonstrate that the intervention does not cause worsening of the illness symptoms apart from the usual fluctuations of the natural course."|End of Trial|Per protocol||units on a scale||Standard Deviation|Mean
830723|NCT01232790|Secondary|Brief Psychiatric Rating Scale (BPRS)Total Score|"Brief Psychiatric Rating Scale (BPRS) utilized before and after treatment. BPRS total score is a total of the 18 item scores with a range of 18-126. It is used to measure schizophrenia symptoms and to assess change in them over time. There are 18 symptom sub scores. Each symptom is rated 1-7 (not present to extremely severe) and then all items are summed for the total score. Higher scores indicate more severe symptoms.
The BPRS is the gold-standard overall measure of schizophrenia symptoms which will be utilized to demonstrate that the intervention does not cause worsening of the illness symptoms apart from the usual fluctuations of the natural course."|Pre Screening|Per protocol||units on a scale||Standard Deviation|Mean
830724|NCT01232790|Secondary|Brief Visuospatial Memory Test (BVMT) RAW SCORE.|Brief Visuospatial Memory Test (BVMT) is a measure of visuospatial memory. This task includes three trials of six geometric figures printed in a 2 x 3 array on separate pages. The respondent views the stimulus page for 10 seconds and is asked to draw as many of the figures as possible in their correct location on a page in the response booklet. A Delayed Recall Trial is administered after a 25-minute delay. Scoring is based on accuracy of the figure as well as its location on the page. A range of 0-12 per trial is possible(0-36 total). Higher scores are better.|Follow Up 2nd Leg of Crossover (5 Days)|Per protocol||units on a scale||Standard Deviation|Mean
830725|NCT01232790|Secondary|Brief Visuospatial Memory Test (BVMT) RAW SCORE.|Brief Visuospatial Memory Test (BVMT) is a measure of visuospatial memory. This task includes three trials of six geometric figures printed in a 2 x 3 array on separate pages. The respondent views the stimulus page for 10 seconds and is asked to draw as many of the figures as possible in their correct location on a page in the response booklet. A Delayed Recall Trial is administered after a 25-minute delay. Scoring is based on accuracy of the figure as well as its location on the page. A range of 0-12 per trial is possible(0-36 total). Higher scores are better.|Baseline 2nd Leg of Crossover|Subjects analyzed are those with complete data at 2nd baseline in the crossover and could include those that had dropped from the study if data was collected prior to drop out.||units on a scale||Standard Deviation|Mean
830726|NCT01232790|Secondary|Brief Visuospatial Memory Test (BVMT) RAW SCORE.|Brief Visuospatial Memory Test (BVMT) is a measure of visuospatial memory. This task includes three trials of six geometric figures printed in a 2 x 3 array on separate pages. The respondent views the stimulus page for 10 seconds and is asked to draw as many of the figures as possible in their correct location on a page in the response booklet. A Delayed Recall Trial is administered after a 25-minute delay. Scoring is based on accuracy of the figure as well as its location on the page. A range of 0-12 per trial is possible(0-36 total). Higher scores are better.|Follow Up 1st Leg of Crossover (5 Days)|Per protocol||units on a scale||Standard Deviation|Mean
830727|NCT01232790|Primary|BACS Composite RAW Score|"The Brief Assessment of Cognition in Schizophrenia (BACS) is an instrument that assesses the aspects of cognition found to be most impaired and most strongly correlated with outcome in patients with schizophrenia.
The BACS composite raw score the total of the raw scores for the 6 subtests of the BACS (Verbal memory, token motor, digit sequencing, verbal fluency, symbol coding and executive functioning). The range, so we could be from 0-435. A high score total score is more favorable and indicates a higher level of cognition.
The BACS requires less than 35 min to complete in patients with schizophrenia, yields a high completion rate in these patients, and has high reliability. The BACS was found to be as sensitive to cognitive impairment in patients with schizophrenia as a standard battery of tests that required over 2 h to administer. It is the raw sum of the test items and higher scores are favorable."|Follow Up 2nd Leg of Crossover (5 Days)|Subjects analyzed are those with complete data at follow up and does not include those dropped out from the study.||units on a scale||Standard Deviation|Mean
830745|NCT01232829|Secondary|Time to Disease Progression|Eighteen patients were evaluable for the time to disease progression endpoint.|From registration to documentation of disease progression, assessed up to 2 years|All patients meeting the eligibility criteria and who received treatment per protocol (n=18) were evaluable for the progression-free survival.||months||95% Confidence Interval|Median
830728|NCT01232790|Primary|BACS Composite RAW Score|"The Brief Assessment of Cognition in Schizophrenia (BACS) is an instrument that assesses the aspects of cognition found to be most impaired and most strongly correlated with outcome in patients with schizophrenia.
The BACS composite raw score the total of the raw scores for the 6 subtests of the BACS (Verbal memory, token motor, digit sequencing, verbal fluency, symbol coding and executive functioning). The range, so we could be from 0-435. A high score total score is more favorable and indicates a higher level of cognition.
The BACS requires less than 35 min to complete in patients with schizophrenia, yields a high completion rate in these patients, and has high reliability. The BACS was found to be as sensitive to cognitive impairment in patients with schizophrenia as a standard battery of tests that required over 2 h to administer. It is the raw sum of the test items and higher scores are favorable."|Baseline 2nd Leg of Crossover|Subjects analyzed are those with complete data at baseline prior to dropout from the study.||units on a scale||Standard Deviation|Mean
830729|NCT01232790|Secondary|Brief Visuospatial Memory Test (BVMT) RAW SCORE.|Brief Visuospatial Memory Test (BVMT) is a measure of visuospatial memory. This task includes three trials of six geometric figures printed in a 2 x 3 array on separate pages. The respondent views the stimulus page for 10 seconds and is asked to draw as many of the figures as possible in their correct location on a page in the response booklet. A Delayed Recall Trial is administered after a 25-minute delay. Scoring is based on accuracy of the figure as well as its location on the page. A range of 0-12 per trial is possible(0-36 total). Higher scores are better.|Baseline 1st Leg of Crossover|Per protocol||units on a scale||Standard Deviation|Mean
830730|NCT01232790|Secondary|Brief Visuospatial Memory Test (BVMT) RAW SCORE.|Brief Visuospatial Memory Test (BVMT) is a measure of visuospatial memory. This task includes three trials of six geometric figures printed in a 2 x 3 array on separate pages. The respondent views the stimulus page for 10 seconds and is asked to draw as many of the figures as possible in their correct location on a page in the response booklet. A Delayed Recall Trial is administered after a 25-minute delay. Scoring is based on accuracy of the figure as well as its location on the page. A range of 0-12 per trial is possible(0-36 total). Higher scores are better.|Change from Baseline at Follow Up (Baseline - Follow Up)|Subjects analyzed are those with complete data at all timepoints and does not include those that had dropped from the study.||units on a scale||Standard Deviation|Mean
830731|NCT01232790|Primary|BACS Composite RAW Score|"The Brief Assessment of Cognition in Schizophrenia (BACS) is an instrument that assesses the aspects of cognition found to be most impaired and most strongly correlated with outcome in patients with schizophrenia.
The BACS composite raw score the total of the raw scores for the 6 subtests of the BACS (Verbal memory, token motor, digit sequencing, verbal fluency, symbol coding and executive functioning). The range, so we could be from 0-435. A high score total score is more favorable and indicates a higher level of cognition.
The BACS requires less than 35 min to complete in patients with schizophrenia, yields a high completion rate in these patients, and has high reliability. The BACS was found to be as sensitive to cognitive impairment in patients with schizophrenia as a standard battery of tests that required over 2 h to administer. It is the raw sum of the test items and higher scores are favorable."|Follow Up 1st Leg of Crossover (5 Days)|Per protocol||units on a scale||Standard Deviation|Mean
830732|NCT01232790|Secondary|Brief Visuospatial Memory Test (BVMT) RAW SCORE.|Brief Visuospatial Memory Test (BVMT) is a measure of visuospatial memory. This task includes three trials of six geometric figures printed in a 2 x 3 array on separate pages. The respondent views the stimulus page for 10 seconds and is asked to draw as many of the figures as possible in their correct location on a page in the response booklet. A Delayed Recall Trial is administered after a 25-minute delay. Scoring is based on accuracy of the figure as well as its location on the page. A range of 0-12 per trial is possible(0-36 total). Higher scores are better.|Follow Up (5 days)|Subjects analyzed are those with complete data at follow up in the crossover and does not include those that had dropped from the study.||units on a scale||Standard Deviation|Mean
830733|NCT01232790|Secondary|Brief Visuospatial Memory Test (BVMT) RAW SCORE.|Brief Visuospatial Memory Test (BVMT) is a measure of visuospatial memory. This task includes three trials of six geometric figures printed in a 2 x 3 array on separate pages. The respondent views the stimulus page for 10 seconds and is asked to draw as many of the figures as possible in their correct location on a page in the response booklet. A Delayed Recall Trial is administered after a 25-minute delay. Scoring is based on accuracy of the figure as well as its location on the page. A range of 0-12 per trial is possible(0-36 total). Higher scores are better.|Baseline|All participants were analyzed that had baseline data collected (including any that did not complete the time frame).||units on a scale||Standard Deviation|Mean
830734|NCT01232790|Secondary|Letter/Number Sequencing Task Tests for Attention, Concentration & Mental Control (LNS) RAW SCORE.|Letter Number Sequencing (LNS) is a brief, standardized executive function task used to assess verbal working memory performance. The test involves a 24-item Experimental Condition, in which participants are read a series of letters and numbers and asked to recite both back in ascending order, with the numbers first and then the letters. Participants receive one point for each correct answer for a range of 0-24. Higher scores are better.|Follow Up 2nd Leg of Crossover (5 Days)|Subjects analyzed are those with complete data at 2nd follow up in the crossover and does not include those that had dropped from the study.||units on a scale||Standard Deviation|Mean
830735|NCT01232790|Secondary|Letter/Number Sequencing Task Tests for Attention, Concentration & Mental Control (LNS) RAW SCORE.|Letter Number Sequencing (LNS) is a brief, standardized executive function task used to assess verbal working memory performance. The test involves a 24-item Experimental Condition, in which participants are read a series of letters and numbers and asked to recite both back in ascending order, with the numbers first and then the letters. Participants receive one point for each correct answer for a range of 0-24. Higher scores are better.|Baseline 2nd Leg of Crossover|Subjects analyzed are those with complete data at 2nd baseline in the crossover and could include those that had dropped from the study if data was collected prior to drop out.||units on a scale||Standard Deviation|Mean
830736|NCT01232790|Secondary|Letter/Number Sequencing Task Tests for Attention, Concentration & Mental Control (LNS) RAW SCORE.|Letter Number Sequencing (LNS) is a brief, standardized executive function task used to assess verbal working memory performance. The test involves a 24-item Experimental Condition, in which participants are read a series of letters and numbers and asked to recite both back in ascending order, with the numbers first and then the letters. Participants receive one point for each correct answer for a range of 0-24. Higher scores are better.|Follow Up 1st Leg of Crossover (5 Days)|Subjects analyzed are those with complete data at follow up and does not include those that had dropped from the study.||units on a scale||Standard Deviation|Mean
830737|NCT01232790|Secondary|Letter/Number Sequencing Task Tests for Attention, Concentration & Mental Control (LNS) RAW SCORE.|Letter Number Sequencing (LNS) is a brief, standardized executive function task used to assess verbal working memory performance. The test involves a 24-item Experimental Condition, in which participants are read a series of letters and numbers and asked to recite both back in ascending order, with the numbers first and then the letters. Participants receive one point for each correct answer for a range of 0-24. Higher scores are better.|Baseline 1st Leg of Crossover|Subjects analyzed are those with complete data at baseline prior to dropout from the study.||units on a scale||Standard Deviation|Mean
830738|NCT01232790|Secondary|Letter/Number Sequencing Task Tests for Attention, Concentration & Mental Control (LNS) RAW SCORE.|Letter Number Sequencing (LNS) is a brief, standardized executive function task used to assess verbal working memory performance. The test involves a 24-item Experimental Condition, in which participants are read a series of letters and numbers and asked to recite both back in ascending order, with the numbers first and then the letters. Participants receive one point for each correct answer for a range of 0-24. Higher scores are better.|Change from Baseline at Follow Up (5 days)|Subjects analyzed are those with complete data at follow up and does not include those that had dropped from the study.||units on a scale||Standard Deviation|Mean
830739|NCT01232790|Secondary|Letter/Number Sequencing Task Tests for Attention, Concentration & Mental Control (LNS) RAW SCORE.|Letter Number Sequencing (LNS) is a brief, standardized executive function task used to assess verbal working memory performance. The test involves a 24-item Experimental Condition, in which participants are read a series of letters and numbers and asked to recite both back in ascending order, with the numbers first and then the letters. Participants receive one point for each correct answer for a range of 0-24. Higher scores are better.|Follow Up (5 days)|Subjects analyzed are those with complete data at follow up and does not include those that had dropped from the study.||units on a scale||Standard Deviation|Mean
830740|NCT01232790|Secondary|Letter/Number Sequencing Task Tests for Attention, Concentration & Mental Control (LNS) RAW SCORE.|Letter Number Sequencing (LNS) is a brief, standardized executive function task used to assess verbal working memory performance. The test involves a 24-item Experimental Condition, in which participants are read a series of letters and numbers and asked to recite both back in ascending order, with the numbers first and then the letters. Participants receive one point for each correct answer for a range of 0-24. Higher scores are better.|Baseline|All participants were analyzed that had baseline data collected (including any that did not complete the time frame).||units on a scale||Standard Deviation|Mean
830741|NCT01232790|Primary|BACS Composite RAW Score|"The Brief Assessment of Cognition in Schizophrenia (BACS) is an instrument that assesses the aspects of cognition found to be most impaired and most strongly correlated with outcome in patients with schizophrenia.
The BACS composite raw score the total of the raw scores for the 6 subtests of the BACS (Verbal memory, token motor, digit sequencing, verbal fluency, symbol coding and executive functioning). The range, so we could be from 0-435. A high score total score is more favorable and indicates a higher level of cognition.
The BACS requires less than 35 min to complete in patients with schizophrenia, yields a high completion rate in these patients, and has high reliability. The BACS was found to be as sensitive to cognitive impairment in patients with schizophrenia as a standard battery of tests that required over 2 h to administer. It is the raw sum of the test items and higher scores are favorable."|Baseline 1st Leg of Crossover|Subjects analyzed are those with complete data at baseline prior to dropout from the study.||units on a scale||Standard Deviation|Mean
830742|NCT01232790|Primary|BACS Composite RAW Score|"The Brief Assessment of Cognition in Schizophrenia (BACS) is an instrument that assesses the aspects of cognition found to be most impaired and most strongly correlated with outcome in patients with schizophrenia.
The BACS composite raw score the total of the raw scores for the 6 subtests of the BACS (Verbal memory, token motor, digit sequencing, verbal fluency, symbol coding and executive functioning). The range, so we could be from 0-435. A high score total score is more favorable and indicates a higher level of cognition.
The BACS requires less than 35 min to complete in patients with schizophrenia, yields a high completion rate in these patients, and has high reliability. The BACS was found to be as sensitive to cognitive impairment in patients with schizophrenia as a standard battery of tests that required over 2 h to administer. It is the raw sum of the test items and higher scores are favorable."|Change from Baseline at Follow Up (5 days)|Subjects analyzed are only those with complete data at baseline and 5 day follow up in the study.||units on a scale||Standard Deviation|Mean
830743|NCT01232790|Primary|BACS Composite RAW Score|"The Brief Assessment of Cognition in Schizophrenia (BACS) is an instrument that assesses the aspects of cognition found to be most impaired and most strongly correlated with outcome in patients with schizophrenia.
The BACS composite raw score the total of the raw scores for the 6 subtests of the BACS (Verbal memory, token motor, digit sequencing, verbal fluency, symbol coding and executive functioning). The range, so we could be from 0-435. A high score total score is more favorable and indicates a higher level of cognition.
The BACS requires less than 35 min to complete in patients with schizophrenia, yields a high completion rate in these patients, and has high reliability. The BACS was found to be as sensitive to cognitive impairment in patients with schizophrenia as a standard battery of tests that required over 2 h to administer. It is the raw sum of the test items and higher scores are favorable."|Follow Up (5 days)|Subjects analyzed are those with complete data at follow up and does not include those that had dropped from the study.||units on a scale||Standard Deviation|Mean
830744|NCT01232790|Primary|BACS Composite RAW Score|"The Brief Assessment of Cognition in Schizophrenia (BACS) is an instrument that assesses the aspects of cognition found to be most impaired and most strongly correlated with outcome in patients with schizophrenia.
The BACS composite raw score the total of the raw scores for the 6 subtests of the BACS (Verbal memory, token motor, digit sequencing, verbal fluency, symbol coding and executive functioning). The range, so we could be from 0-435. A high score total score is more favorable and indicates a higher level of cognition.
The BACS requires less than 35 min to complete in patients with schizophrenia, yields a high completion rate in these patients, and has high reliability. The BACS was found to be as sensitive to cognitive impairment in patients with schizophrenia as a standard battery of tests that required over 2 h to administer. It is the raw sum of the test items and higher scores are favorable."|Baseline|Subjects analyzed are those with complete data at baseline prior to dropout from the study.||units on a scale||Standard Deviation|Mean
832071|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Plasmin-Antiplasmin (PAP) Complex|The plasmin-antiplasmin (PAP) complex is a marker of thrombin and fibrin formation and turnover.|Baseline to Month 6|Per-protocol population||ng/mL||Standard Error|Least Squares Mean
830746|NCT01232829|Secondary|Survival|Survival was estimated using the Kaplan-Meier (1958) method.|From registration to death due to any cause, assessed up to 2 years|All patients meeting the eligibility criteria and who received treatment per protocol (n=18) were evaluable for the overall survival endpoint.||months||95% Confidence Interval|Median
830747|NCT01232829|Primary|Survival Rate|The primary endpoint of the study was 6-month survival. The proportion of successes was estimated by the number of successes divided by the total number of evaluable patients.|6 months|All patients meeting the eligibility criteria and who received treatment were considered evaluable for the primary endpoint. All patients treated per protocol (n=18) were evaluable for the 6-month survival endpoint.||participants|||Number
830750|NCT01232894|Primary|Change From Baseline on Clinical COPD Questionnaire (CCQ) Score|The Clinical Chronic Obstructive Pulmonary disease (COPD) Questionnaire (CCQ) is a self-administered questionnaire containing ten questions, divided into three domains: symptoms, mental and functional state. The questions are based on a 7-point scale where a '0' means having no limitations and a '6' means extreme or complete limitations. The final score is the mean of all ten questions. The CCQ score was recalculated according to the paper by Van der Molen et al., 2003. The statistical significance remained the same.|Baseline and 12 weeks|Full analysis Set: all patients who received at least one dose of study drug and have evaluable data for analysis.||units on a scale||Standard Deviation|Mean
830751|NCT01232920|Secondary|Number of Eyes With Resolution of Macular Edema||6 months|||Eyes|Participants||Number
830752|NCT01232920|Secondary|Change in Best Spectacle-corrected Visual Acuity (BSCVA)|Change in best spectacle-corrected visual acuity (BSCVA) from baseline. Analysis on eye level|6 months|||LogMAR|Participants|Standard Deviation|Mean
830753|NCT01232920|Secondary|Time to Control of Inflammation||6 months|||days||Inter-Quartile Range|Median
830754|NCT01232920|Primary|Number of Participants Achieving Treatment Success|"TREATMENT SUCCESS is defined as controlled ocular inflammation in both eyes with less than or equal to 10 mg/day of prednisone and/or 2 topical steroid drops/day sustained for 2 visits separated by at least 28 days (control of inflammation and prednisone dose must be achieved by 5-month visit and sustained until 6-month visit).
Discontinuation of study medication at any time due to efficacy, tolerability, or safety may result in a declaration of TREATMENT FAILURE. Note that all patients will be classified as either a treatment success or failure."|6 months|||participants|||Number
830755|NCT01233050|Secondary|Analysis of Inappropriately Used Antibiotics||within 35 days of randomization to treatment assignment||||||
830756|NCT01233050|Secondary|Length of Hospital Stay||within 35 days of randomization to treatment assignment|||days||Standard Deviation|Mean
830757|NCT01233050|Secondary|Number and Percentage of Participants With Organ Space Infection||within 35 days of randomization to treatment assignment|||Participants|||Count of Participants
830758|NCT01233050|Secondary|Number and Percentage of Participants With Deep Wound Infection||within 35 days of randomization to treatment assignment|||Participants|||Count of Participants
830759|NCT01233050|Secondary|Bacterial Pathogens Present in Documented Surgical Site Infection||within 35 days of randomization to treatment assignment|||Participants|||Count of Participants
830760|NCT01233050|Secondary|Time to Develop Surgical Site Infection|average time from surgery to surgical site infection diagnosis|within 35 days of randomization to treatment assignment|||days||Standard Error|Mean
830761|NCT01233050|Primary|The Primary Objective Measures the Proportion of Patients With Superficial Site Infection as Defined by the CDC.|The primary objective compares the efficacy of 2% chlorhexidine gluconate / 70% isopropyl alcohol (ChloraPrep) to Iodine Povacrylex [0.7% available Iodine] / 74% Isopropyl Alcohol (DuraPrep) in the prevention of superficial surgical site infection. The primary objective will be measured by the number and percentage of patients with superficial site infection as defined by the CDC.|within 35 days of randomization to treatment assignment|||Participants|||Count of Participants
830762|NCT01233076|Primary|Overall Vision Quality|Overall vision quality, as interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear. Overall vision quality is evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.|1 week of wear|Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses.||units on a scale||Standard Deviation|Mean
830763|NCT01238822|Primary|Attention Deficit / Hyperactivity Disorder Total Sum Score of All 18 ADHD Symptom Items|"Parent and teacher Vanderbilt ADHD Rating Scales - Attention Deficit / Hyperactivity Disorder Total sum score of all 18 ADHD symptom items - range equals 0-54
O - No ADHD symptoms 54 - Highest ADHD symptoms"|end of first week, end of second week, end of third week, end of fourth week. Total of 4 weeks.|Intent to treat with imputation for missing data.||Score||Standard Deviation|Mean
830764|NCT01238848|Primary|Hospitalization Days|hospitalization days|Participants will be followed for the duration of hospitalization, an expected average of 4 days|||days||Standard Deviation|Median
830765|NCT01238848|Secondary|Length of Oxygen Use|Length of oxygen use (days)|Participants will be followed for the duration of hospitalization, an expected average of 4 days|||days||Standard Deviation|Median
830783|NCT01238900|Secondary|Frequency and Severity of Adverse Events (Including Stent Migration)|Adverse events were defined and graded using the 2010 American Society for Gastrointestinal Endoscopy consensus criteria|up to 12 months|Stent migration was seen in 9/23 patients (5 downstream, 4 upstream). It was without clinical complications except in one case. Post-procedure pain experienced by 1 patient was effectively treated by downgrading the stent size to a smaller diameter.||participants|||Number
830766|NCT01238861|Secondary|Change From Baseline in Mean Fraction Exhaled Nitric Oxide (FeNO) at Week 52|Data was summarized by each treatment group. In addition, data was summarized together for “EOS+ and EOS- Placebo” arms and “EOS+ and EOS- benralizumab 100 mg” arms.|Baseline up to Week 52|"The mITT population included all randomized participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||parts per billion||Standard Deviation|Mean
830767|NCT01238861|Secondary|Change From Baseline in Percentage of Nocturnal Awakening-Free Nights at Week 51-52|Percentage of nocturnal awakening-free nights were analyzed on a bi-weekly basis and compared to baseline scores. Data was summarized by each treatment group. In addition, data was summarized together for “EOS+ and EOS- Placebo” arms and “EOS+ and EOS- benralizumab 100 mg” arms.|Baseline up to Week 51-52|"The mITT population included all randomized participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||percent nocturnal awakening-free nights||Standard Deviation|Mean
830768|NCT01238861|Secondary|Change From Baseline in EQ-5D Visual Analog Scale (VAS) at Week 52|The utility-based EQ-5D questionnaire comprises of two parts and provides a generic measure of health for clinical and economic appraisal. The EQ-5D VAS was measured from 0 (worst imaginable health state) to 100 (best imaginable health state). Data was summarized by each treatment group. In addition, data was summarized together for “EOS+ and EOS- Placebo” arms and “EOS+ and EOS- benralizumab 100 mg” arms.|Baseline and Week 52|"The mITT population included all randomized participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||units on a scale||Standard Deviation|Mean
830769|NCT01238861|Secondary|Change From Baseline in European Quality of Life - 5 Dimensions (EQ-5D) Health State Evaluation at Week 52|The utility-based EQ-5D questionnaire comprises of two parts and provides a generic measure of health for clinical and economic appraisal. The health state valuation was the summary score of mobility, self-care, usual activities, pain/discomfort and anxiety/depression on a 3 category scale (no problem, moderate problem, severe problems). Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. Data was summarized by each treatment group. In addition, data was summarized together for “EOS+ and EOS- Placebo” arms and “EOS+ and EOS- benralizumab 100 mg” arms.|Baseline and Week 52|"The mITT population included all randomized participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||units on a scale||Standard Deviation|Mean
830770|NCT01238861|Secondary|Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Score at Week 52|AQLQ: a 32-item questionnaire evaluating quality of life of participants with asthma including 4 domains (symptoms, activity limitations, emotional function, and environmental stimuli). Participants were asked to recall their experiences during the previous 2 weeks and to score each of the 32 questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score was calculated as the mean response to all questions. The 4 domain scores were the means of the responses to the questions in each of the domains. Overall AQLQ score and 4 domain scores ranged from 7 (no impairment) to 1 (severe impairment). The AQLQ(S) responses were categorized as improvement (defined as change from baseline >=0.5), no change (defined as change from baseline >= -0.5 to less than [<] 0.5), and worse (defined as change from baseline < -0.5). Data was summarized by each treatment group.|Baseline and Week 52|"The mITT population included all randomized participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively. Data was summarized together for “EOS+ and EOS- Placebo” arms and “EOS+ and EOS- benralizumab 100 mg” arms."||units on a scale||Standard Deviation|Mean
830771|NCT01238861|Secondary|Change From Baseline in Peak Expiratory Flow (PEF) at Week 52|The PEF is a participant’s maximum speed of expiration, as measured with a peak flow meter. Peak flow testing for PEF was performed while sitting or standing prior to using any medication (if needed) for asthma. Home PEF was determined separately for morning and evening, and were averaged for each participant. Data was summarized by each treatment group. In addition, data was summarized together for “EOS+ and EOS- Placebo” arms and “EOS+ and EOS- benralizumab 100 mg” arms.|Baseline and Week 52|"The mITT population included all randomized participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||liters per minute||Standard Deviation|Mean
830772|NCT01238861|Secondary|Change From Baseline in Mean Forced Vital Capacity (FVC) at Week 52|Forced Vital Capacity (FVC) was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.|Baseline and Week 52|"The mITT population included all randomized participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||liters||Standard Deviation|Mean
830773|NCT01238861|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 52|FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Data was summarized by each treatment group. In addition, data was summarized together for “EOS+ and EOS- Placebo” arms and “EOS+ and EOS- benralizumab 100 mg” arms.|Baseline and Week 52|"The mITT population included all randomized participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||liters||Standard Deviation|Mean
830784|NCT01238900|Secondary|Ease of Stent Removal|The ease of stent removal was graded on a 4-point scale (with ease, mild difficulty, significant difficulty, and failed).|at time of procedure|||participants|||Number
830785|NCT01238900|Secondary|Number of Endoscopic Treatments Per Patient|The average number of ERCPs performed per patient required for resolution of benign strictures.|At time of procedure|||endoscopic treatments||Full Range|Mean
830795|NCT01238991|Primary|Number of Participants With Brain Abnormalities in Magnetic Resonance Imaging (MRI) Data|Number of participants with brain abnormalities in MRI data that are either consistent or not consistent with AD, as determined by radiologists.|Baseline up to 24 months|The population for safety analysis consisted of all enrolled participants who received at least one injection of study medication in this study. Since the study was early terminated and the data could not be obtained as planned, the MRI data were not summarized.|||||
830774|NCT01238861|Secondary|Change From Baseline in Rescue Medication Use at Week 51-52|Participants were provided inhalers of the same dose (medium- or high-dose) inhaled corticosteroid (ICS) plus long-acting beta antagonist (LABA) combination product as baseline prophylactic medication and continued with same dose throughout the study. Rescue medications such as short-term beta2 agonists were used as first-line treatment for worsening asthma symptoms. Investigator prescribed additional short term asthma controller medications included additional ICS, theophylline, inhaled cromones or antimuscarinics; if asthma symptoms remained mild but not resolved. If asthma symptoms worsened, participants received an oral corticosteroid burst. All rescue medications use with prophylactic medication (+ prophylactic) and without prophylactic medication (- prophylactic) was recorded in asthma symptom dairy by participant. Rescue medication use was analyzed on a bi-weekly basis and compared to baseline scores.|Baseline up to Week 51-52|"The mITT population included all randomized participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively. Data was summarized together for “EOS+ and EOS- Placebo” arms and “EOS+ and EOS- benralizumab 100 mg” arms."||rescue medication per 2 weeks||Standard Deviation|Mean
830775|NCT01238861|Secondary|Change From Baseline in Mean Asthma Symptom Diary Score at Week 51-52|Asthma Symptom Diary included 7 questions about the participant symptom and the overall impact of treatment on the disease during the study period. Mean scores of the 7 questions were calculated to identify asthma symptom-free days. Asthma Symptom Diary Scores were analyzed on a bi-weekly basis and compared to baseline scores. Overall symptom score=(daytime frequency score + daytime severity score + nighttime severity score)/3, where total score ranges from 0 to 9. Higher score represents worsening. Mean asthma symptom diary score were summarized together for all participants. Mean asthma symptom diary score were summarized together for all participants. In addition, data was summarized together for “EOS+ and EOS- Placebo” arms and “EOS+ and EOS- benralizumab 100 mg” arms.|Baseline up to Week 51-52|"The mITT population included all randomized participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||units on a scale||Standard Deviation|Mean
830776|NCT01238861|Secondary|Change From Baseline in Mean Total Nasal Symptoms Score (TNSS) at Week 52|Total Nasal Symptoms Score (TNSS) is a 3-item questionnaire, the sum of nasal symptoms, namely, nasal obstruction (rhinorrhea), nasal congestion, and nasal itching/sneezing. Each symptom was rated on a scale from 0-3, with 0 representing no symptoms, 1 mild, 2 moderate, and 3 severe symptoms. TNSS score was a summation of the 3 individual nasal symptom. TNSS score could range from 0 to 9 where higher score indicates worsening. Data was summarized by each treatment group. In addition, data was summarized together for “EOS+ and EOS- Placebo” arms and “EOS+ and EOS- benralizumab 100 mg” arms.|Baseline up to Week 52|"The mITT population included all randomized participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||units on a scale||Standard Deviation|Mean
830777|NCT01238861|Secondary|Change From Baseline in Asthma Control Questionnaire (6-items) (ACQ-6) Score at Week 52|Asthma Control Questionnaire (ACQ) is a participant-reported questionnaire to assess the asthma control with 6 items assessing night-time waking, symptoms on waking, activity limitation, shortness of breath, wheeze, and rescue short-acting beta agonist use. Each item was rated on a 7-point Likert scale ranging from 0 (no impairment) to 6 (maximum impairment). Overall ACQ score was the mean of the 6 item scores with a score range of 0 (well controlled) to 6 (extremely poor controlled). Data collected on Day 1 prior to dosing was considered as baseline. Results were reported for overall ACQ score. ACQ-6 score was summarized together for all participants.|Baseline up to Week 52|"The mITT population included all randomized participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||units on a scale||Standard Deviation|Mean
830778|NCT01238861|Secondary|Percentage of Participants With Anti-Drug Antibodies (ADA) to Benralizumab in Eosinophilic Phenotype (EOS+) Participants|Immunogenicity assessment included determination of anti-drug (benralizumab) antibodies in serum samples. ADA positive was defined as a titer >=50 at any point in the study. It was observed at baseline and any visit during the study.|Baseline up to Week 92|The mITT population included all randomized participants who received any dose of investigational product.||percentage of participants|||Number
830779|NCT01238861|Secondary|Dose-Normalized Minimum Observed Serum Trough Concentration for Benralizumab at Steady-State (Ctrough, ssD)||Pre-dose (0 hour), Post-dose on Day 1, 6, Week 4, 16, 24, 32, 40, and 52|The PK Population included all participants who received at least one dose of benralizumab and had at least one quantifiable PK observation. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for PK in the 100 mg benralizumab group.||microgram per milliliter||Standard Deviation|Mean
830780|NCT01238861|Secondary|Minimum Observed Serum Trough Concentration for Benralizumab at Steady-State (Ctrough, ss)||Pre-dose (0 hour), Post-dose on Day 1, 6, Week 4, 16, 24, 32, 40, and 52|The Pharmacokinetic (PK) Population included all participants who received at least one dose of benralizumab and had at least one quantifiable PK observation. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for PK in the 100 mg benralizumab group.||microgram per milliliter||Standard Deviation|Mean
830781|NCT01238861|Secondary|Dose Response in EOS+ Participants||Baseline up to Week 66|Due to change in planned analysis after unblinding of study data, dose response was not performed.|||||
830782|NCT01238861|Primary|Annual Asthma Exacerbation Rate (AER) for Eosinophilic Phenotype (EOS+) Participants|The annual asthma exacerbation rate (AER) was calculated as the total number of observed exacerbations in each group up to week 52, divided by total duration of person-year follow-up in each group. An asthma exacerbation is defined as a progressive increase of asthma symptoms (cough, wheeze, chest tightness, and/or shortness of breath) that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 days as prescribed or administered by the investigator or healthcare provider; or 2) participant initiation of systemic corticosteroids (tablets, suspension or injection) for a duration of at least 3 days as outlined in the Asthma Action Plan provided to the participant by the investigator on Day 1.|Week 1 up to Week 52|The modified intent-to-treat (mITT) population included all randomized participants who received any dose of investigational product.||AER events/person-year|||Number
830786|NCT01238900|Primary|Long-term Success Rate in Resolution of Biliary Strictures|Long-term success was defined as no clinical evidence of recurrence of the biliary stricture during the follow-up period as documented by laboratory findings or imaging and no further need for further endoscopic or surgical interventions.|at least 12 months after stent removal|Per-protocol analysis, the 18 participants available for long term success follow-up consisted of: 11 with CP, 3 with OLT, and 4 others. Intention to treat analysis of long-term success consisted of 22 overall patients, 12 CP patients, 3 OLT patients, and 7 other patients. This analysis included all patients lost to follow-up as long-term failures.||participants|||Number
830787|NCT01238900|Primary|Short Term Success Rate in the Resolution of Biliary Strictures|Short-term success was defined as resolution of the stricture as documented by rapid drainage of contrast out of the proximal biliary tree and easy passage of stone extraction balloon inflated to the size of the proximal bile duct. If the biliary stricture had resolved at the 6-month follow-up ERCP, patients were classified as short-term success. If stricture was not resolved at 6-month ERCP then a new SEMS was placed; if the stricture had resolved at the time of the second stent removal, the patient was also classified as short-term success.|6 months|Of the 23 participants that entered the study, 22 saw short-term success. The population consisted of 14 Chronic pancreatitis patients, 4 postorthotopic liver transplant patients, and 5 others.||participants|||Number
830788|NCT01238991|Other Pre-specified|The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 12, 26, 36, 52, 66, 78, 91 and 104.|The MMSE is a brief, structured examination of cognitive function. It has a total score of 30 points, and any score equal to or lower than 26 points indicates cognitive impairment.|Baseline up to 24 Months|The efficacy analysis population was all of the participants who received at least one injection in this study and had baseline efficacy evaluation in the preceding study and at least one efficacy evaluation post injection. Since the study was early terminated and the data could not be obtained as planned, the MMSE scores were not summarized.|||||
830789|NCT01238991|Other Pre-specified|The Mean Changes in Neuropsychological Test Battery (NTB) Score From Baseline at Week 26, 52, 78 and 104.|The NTB is a composite of nine widely used neuropsychological tests that assess immediate and delayed recall of verbal and visual information, attention, verbal fluency and executive function. The cognitive tests included in the NTB are the Wechsler Memory Scale (WMS) Visual-Paired Associates (immediate and delayed), WMS-Verbal Paired Associates (immediate and delayed), Rey Auditory Verbal Learning Test (immediate and delayed), WMS-Digit Span, Controlled Word Association Test, and Category Fluency Test. The NTB z-score is used for analysis. The z-score for each component is calculated through the following formula: z = (y_visit – y_base)/SD_base, where y_visit is a value at a particular time point and y_base is the average test score, and SD_base is the SD based on all participants’ observed baseline scores in the study.|Baseline up to 24 Months|The efficacy analysis population was all of the participants who received at least one injection in this study and had baseline efficacy evaluation in the preceding study and at least one efficacy evaluation post injection. Since the study was early terminated and the data could not be obtained as planned, the NTB scores were not summarized.|||||
830790|NCT01238991|Other Pre-specified|The Mean Changes in Disability Assessment for Dementia (DAD) Score From Baseline at Week 26, 52,78 and 104.|The DAD is administered through an interview with the caregiver and measures instrumental and basic activities of daily living. A total score is obtained by adding the rating for each question and converting this total score out of 100. Higher scores represent less disability in ADL while lower scores indicate more dysfunction.|Baseline up to 24 Months|The efficacy analysis population was all of the participants who received at least one injection in this study and had baseline efficacy evaluation in the preceding study and at least one efficacy evaluation post injection. Since the study was early terminated and the data could not be obtained as planned, the DAD scores were not summarized.|||||
830791|NCT01238991|Other Pre-specified|The Mean Changes in Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-Cog) Score From Baseline at Week 26, 52, 78 and 104.|The ADAS-Cog is a 12-item,objective measure of cognitive function, consisting of 1) Word Recall, 2) Naming Objects and Fingers, 3) Following Commands, 4) Constructional Praxis, 5) Ideational Praxis, 6) Orientation, 7) Word Recognition, 8) Recall of Test Instructions, 9) Spoken Language Ability, 10) Word-Finding Difficulty, 11) Comprehension of Spoken Language and 12) Concentration/Distractibility. For this study, the ADAS-Cog total score is derived by summing the individual scores from items 1 to 11, with higher scores indicating a greater degree of impairment. The total score ranges from 0 (no impairment) to 70 (worst impairment).|Baseline up to 24 Months|The efficacy analysis population was all of the participants who received at least one injection in this study and had baseline efficacy evaluation in the preceding study and at least one efficacy evaluation post injection. Since the study was early terminated and the data could not be obtained as planned, the ADAS-Cog scores were not summarized.|||||
830792|NCT01238991|Other Pre-specified|Anti-A-beta IgM (Immunoglobulin M) Titer at Specified Visits|Geotmetric mean of anti-a-beta IgM titer from baseline of the preceding studies through the end of this study|Baseline of preceding studies to month 24 of this study (Week 210)|The immunogenicity analysis population consisted of those in the safety analysis population who had baseline immunogenicity evaluation in the preceding study and at least one immunogenicity evaluation post injection. Since the study was early terminated and the data could not be obtained as planned, the IgM data were not summarized.|||||
830793|NCT01238991|Other Pre-specified|Anti-A-beta IgG (Immunoglobulin G) Titer at Specified Visits|Geometric mean of anti-a-beta IgG titer from baseline of the preceding studies through the end of this study|Baseline of preceding studies to month 24 of this study (Week 210)|The immunogenicity analysis population consisted of those in the safety analysis population who had baseline immunogenicity evaluation in the preceding study and at least one immunogenicity evaluation post injection.||Units/mL||95% Confidence Interval|Geometric Mean
830794|NCT01238991|Primary|Number of Participants With Abnormalities in Neurological Examination|Number of participants with abnormalities in neurological examinations as determined by the investigators. Neurological examinations included Mental Status, Speech, Cranial Nerve Function, Cranial Nerve II, Sensory Function, Motor Function, Coordination, Gait and Station, Reflexes and Deep Tendon Reflexes.|Baseline of the preceding studies through 24 months of this study|The population for safety analysis consisted of all enrolled participants who received at least one injection of study medication in this study.||Participants|||Number
840389|NCT01328756|Primary|Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Last On-treatment Assessment (LOTA)||Baseline (Week 0), LOTA (Week 104)|Safety population with participants evaluable for this outcome||mmHg||Standard Deviation|Mean
830796|NCT01238991|Primary|Number of Treatment Emergent Adverse Events (AEs) by Severity|Number of mild, moderate, and severe AEs (mild = does not interfere with subject's usual function; moderate = interferes to some extent with subject's usual function; severe = interferes significantly with subject's usual function)|Baseline up to 24 months|The population for safety analysis consisted of all enrolled participants who received at least one injection of study medication in this study.||Events|||Number
830797|NCT01239680|Primary|Biological Response as Characterized by Selected Cytokines, Specifically Tumor Necrosis Factor Alpha (TNFα), Interleukin One (IL-1β), and Interleukin Six (IL-6).|Biological response as characterized by selected cytokines, specifically tumor necrosis factor alpha (TNFα), interleukin one (IL-1β), and interleukin six (IL-6). These are measured using ELISA. Baseline values are expected to be either unobtainable, or in any case less than 50 picograms/ml. If there is a significant inflammatory response, values at 24 hours should be more than 100 picograms/ml for TNFα, IL-1β, and IL-6. Our hypothesis is that there will be a difference between study and control group patients of at least 50 picograms/ml in the levels of these cytokines at 24 hours. Cytokine response is quite variable, and the percentage of outliers (with no cytokine response) in either group may be as high as 50%. .|Change from Baseline in Cytokine Levels at 24 hours|The number of participants who had an intervention and completed the study with all 3 required blood draws.|||||
830798|NCT01239732|Secondary|Biological Progression-free Interval|Biological progression-free interval is defined as the interval from the date of the first administration of any study treatment to the date of the first documented serial elevation of the ovarian cancer mucin CA-125. More precisely, this is defined as the first documented increase in CA-125 levels as follows: (1) CA-125 greater than or equal to 2 times the upper level of normal (ULN) on 2 occasions at least 1 week apart (for participants with CA-125 within normal range pre-treatment) or (2) CA-125 greater than or equal to 2 times the ULN on 2 occasions at least 1 week apart (for participants with elevated CA-125 pre-treatment and initial normalization of CA-125 on-treatment) or (3) CA-125 greater than or equal to 2 times the nadir value, which is the lowest observed CA-125 value per participant on 2 occasions at least 1 week apart (for participants with elevated CA-125 pre-treatment which never normalized).|3 days prior to Day 1 of every cycle, then every 6 weeks during the first year, every 3 months in the second and third year, every 6 months in the fourth year of the study (until data cutoff 07 December 2014, up to 4 years)|Previous studies linking CA-125 levels with bevacizumab exposure as a potential secondary outcome measure for PFS did not produce any reliable information. Therefore, it was decided that data for this outcome measure should not be analyzed, as agreed with the study steering committee.|||||
830799|NCT01239732|Secondary|Overall Survival (OS)|OS was defined as the time from the date of the first administration of any study treatment to the date of death, regardless of the cause of death. Participants without the event of death were censored at the last date in the study, defined as the latest date of the following: the date of first administration of study treatment, date of last study treatment, date of last visit, or date last known to be alive. Kaplan-Meier estimation was used for OS.|First administration of any study treatment until death or data cutoff 07 December 2014, up to 4 years|ITT population||months||95% Confidence Interval|Median
830800|NCT01239732|Secondary|Duration of Objective Response (DOR)|DOR was defined as the time from the first documented response (CR or PR per RECIST v1.0), to the first documented protocol-defined disease progression (i.e., radiologically by RECIST, clinical, or symptomatic) or death, whichever occurred first. Participants who had neither progressed nor died at the time of data cut-off (07 December 2014), or participants who were withdrawn from study, or lost to follow-up without documented progression, were censored. RECIST responders: Participants achieving an overall response of CR (disappearance of all target lesions and non-target lesions) or PR (>=30% decrease in sum of the LD of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non-target lesions). Disease progression: Natural progression or deterioration of the malignancy under study (including new sites of metastasis).|Day 1, at end of Cycles 3 and 6, then every 6 cycles while receiving bevacizumab, and then at bevacizumab cessation, every 26 weeks after cessation of bevacizumab until disease progression or death until data cutoff 07 December 2014, up to 4 years|ITT population||months||95% Confidence Interval|Median
830801|NCT01239732|Secondary|Percentage of Participants Achieving an Overall Response by RECIST Version 1.0 and/or 50% CA-125 Response Criteria|Overall response was only evaluated for participants who were evaluable according to RECIST v1.0 with a measurable disease at baseline and/or according to CA-125 with a pre-treatment CA-125 within 3 days prior to start of any study treatment of at least twice the ULN. RECIST responders: Participants achieving an overall response of CR (disappearance of all target lesions and non-target lesions) or PR (>=30% decrease in sum of the LD of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non target lesions). CA-125 responders: Participants with the value of CA-125 reduced by at least 50% and confirmed with a consecutive CA-125 assessment performed at an interval of at least 28 days.|RECIST: Day 1, at end of Cycles 3 and 6, then every 6 cycles, at bevacizumab cessation, Q26W after cessation; CA-125: 3 days before Day 1 of every cycle, then Q6W(1st year), Q3M(2nd-3rd year), Q6M(4th year); until data cutoff 07Dec2014, up to 4 years|ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome.||percentage of participants||95% Confidence Interval|Number
830802|NCT01239732|Secondary|Percentage of Participants Achieving an Overall Response by 50% Carcinoma Antigen 125 (CA-125) Response Criteria|CA-125 responders: Participants with the value of CA-125 reduced by at least 50% and confirmed with a consecutive CA-125 assessment performed at an interval of at least 28 days. Overall response according to CA-125 was only evaluated for participants with a pre-treatment CA-125 within 3 days prior to start of any study treatment of at least twice the upper limit of normal (ULN).|3 days prior to Day 1 of every cycle, then every 6 weeks (Q6W) during the first year, every 3 months (Q3M) in the second and third year, every 6 months (Q6M) in the fourth year of the study (until data cutoff 07 December 2014, up to 4 years)|ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome.||percentage of participants||95% Confidence Interval|Number
830833|NCT01240200|Primary|Treatment Satisfaction|The primary outcome of the study is to determine differences in treatment satisfaction scores in elderly patients with diabetes treated with basal insulin delivered via a pen device versus a syringe.|at 24 weeks||||||
840390|NCT01328756|Primary|Change From Baseline in Pulse Rate at Last On-treatment Assessment (LOTA)||Baseline (Week 0), LOTA (Week 104)|Safety population with participants evaluable for this outcome||beats per minute||Standard Deviation|Mean
830803|NCT01239732|Secondary|Percentage of Participants Achieving Best Overall Response of Complete Response (CR) or Partial Response (PR) According to RECIST Version 1.0|Best overall response (BOR) according to RECIST Version 1.0 was categorized as: CR, PR, progressive disease (PD), stable disease (SD). CR: disappearance of all target lesions and non-target lesions. PR: >=30% decrease in sum of the longest diameters (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non-target lesions. PD: Natural progression or deterioration of the malignancy under study (including new sites of metastasis). SD: neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started. Participants with a BOR of CR and PR were defined as responders, while participants with a BOR of SD, PD, or unable to assess were defined as non-responders.|Day 1, at end of Cycles 3 and 6, then every 6 cycles while receiving bevacizumab, and then at bevacizumab cessation, every 26 weeks (Q26W) after cessation of bevacizumab until disease progression or death until data cutoff 07 December 2014, up to 4 years|ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome.||percentage of participants||95% Confidence Interval|Number
830804|NCT01239732|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time between the date of first administration of any study treatment and the date of first documented protocol-defined disease progression (that is [i.e.], radiologically by Response Evaluation Criteria In Solid Tumors [RECIST], clinical, or symptomatic) or death, whichever occurred first. Participants who had neither progressed nor died at the time of data cut-off (07 December 2014), or participants who were withdrawn from study, or lost to follow-up without documented progression, were censored. Kaplan-Meier estimation was used for median time to PFS.|Day 1, at end of Cycles 3 and 6, then every 6 cycles while receiving bevacizumab, and then at bevacizumab cessation, every 26 weeks after cessation of bevacizumab until disease progression or death until data cutoff 07 December 2014, up to 4 years|Intent to treat population included all participants who received at least one dose of study medication.||months||95% Confidence Interval|Median
830805|NCT01239732|Primary|Percentage of Participants With at Least One Adverse Event (AE)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|Day 1 up to 30 days after last dose of study treatment (until data cutoff 07 December 2014, up to 4 years)|Safety population||percentage of participants|||Number
830806|NCT01239745|Secondary|Overall Survival|Time in months from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Baseline until death (up to Month 36)|Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study.|||||
830807|NCT01239745|Secondary|Recurrence-free Survival|Recurrence-free survival defined as the time from the initiation of study medication to the date of confirmation of any recurrence - as local or distant breast cancer recurrence; new primary breast cancer (ipsilateral or contralateral), death due to any cause.|Baseline up to Month 36|Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study.|||||
830808|NCT01239745|Secondary|Time to Discontinuation||Baseline up to Month 36|Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study.|||||
830809|NCT01239745|Secondary|Number of Participants With Reasons for Discontinuation From Study Medication||Baseline up to Month 36|Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study.|||||
830810|NCT01239745|Secondary|Percentage of Participants Who Discontinued the Study Medication||Baseline up to Month 36|Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study.|||||
830811|NCT01239745|Secondary|Number of Participants With Concomitant Medications|Concomitant medication (any medication other than, and in addition to, the study medication) taken for any period of time during the study and was coded by World Health Organization (WHO) medical dictionary.|Baseline up to Month 36|Safety analysis set included participants who received at least one dose of the study medication during the observation period.||participants|||Number
830812|NCT01239745|Secondary|Number of Participants With Concomitant Morbidities|Participants who had a concomitant morbidity during the study for any period of time; participants with more than one concomitant morbidity were counted for each of the concomitant morbidity classes applicable.|Baseline up to Month 36|Safety analysis set included participants who received at least one dose of the study medication during the observation period.||participants|||Number
830813|NCT01239745|Primary|Number of Participants With Adverse Events (AEs)|Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness (to study drug) was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.|Baseline up to Month 36|Safety analysis set included participants who received at least one dose of the study medication during the observation period.||participants|||Number
830814|NCT01239797|Secondary|Change in Baseline of Brief Pain Inventory-Short Form (BPI-SF) Scores|"Outcome measure reports the change from baseline of the mean score of pain severity and the change from baseline of the mean score of pain interference between the two treatments using the Brief Pain Inventory-Short Form (BPI-SF). The BPI-SF is a self administered questionnaire developed to assess the severity of pain (the sensory dimension) as well as the degree to which pain interferes with function (the reactive dimension). The BPI-SF uses 0 (No pain, No interference) to 10 (Pain as bad as you can imagine, Highest imaginable interference) numeric rating scale."|Baseline to Study Completion (up to 7 years)||10/2019||||
830815|NCT01239797|Secondary|Median Overall Survival (OS)|Overall Survival (OS), measured in months, was based on Kaplan Meier estimates.|Randomization to 427 deaths (approximately 7 years)||10/2019||||
830834|NCT01240200|Primary|Treatment Satisfaction|The treatment satisfaction scores were obtained from the Diabetes Treatment Satisfaction Questionnaire: Status (DTSQs). The questionnaire contains eight items scored on a seven-point scale (0-6). DTSQs scores range from, e.g, 6 = very satisfied to 0 = very dissatisfied. The total satisfaction score when using the DTSQs ranges from 0 to 36; and the total score is obtained from summed scores from questions 1, 4, 5, 6, 7, and 8. This outcome measure is assessed after the first intervention (at 12 weeks into the study).|12 weeks|||units on a scale||Standard Deviation|Mean
830816|NCT01239797|Primary|Objective Response Rate (ORR)|Objective response rate (ORR) defined as the proportion of participants with a best response on-study of partial response (PR) or better (stringent CR [sCR], complete response [CR], very good partial response [VGPR], and partial response [PR]) based on the Independent Review Committee (IRC) assessment of best response using the European Group for Blood and Bone Marrow Transplant (EBMT) assessment criteria. Participants were censored at the last adequate assessment prior to the start of any subsequent systemic-therapy or at the last adequate assessment prior to 2 missing assessments (> 10 weeks). Participants who died more than 10 weeks after the randomization date and had no on-treatment assessment were censored at the randomization date. Clinical deterioration was not considered progression. Assessments were made every 4 weeks.|Randomization to end of treatment (approximately 2 years)|All participants randomized to any treatment group||percentage of participants||95% Confidence Interval|Number
830817|NCT01239797|Primary|Median Progression Free Survival (PFS)|Primary definition of Progression-free survival (PFS) defined as the time from randomization to the date of first documented tumor progression or death due to any cause. Participants were censored at the last adequate assessment prior to the start of any subsequent systemic-therapy or at the last adequate assessment prior to 2 missing assessments (> 10 weeks). Participants who died more than 10 weeks after the randomization date and had no on-treatment assessment were censored at the randomization date. Clinical deterioration was not considered progression. The primary analysis of PFS was based on the primary definition using the Independent Review Committee (IRC) tumor assessment using the European Group for Blood and Bone Marrow Transplant (EBMT) criteria. Tumor assessments were made every 4 weeks (±1 week) relative to the first dose of study medication.|Randomization until 326 events (approximately 2 years)|All participants randomized to any treatment group||months||95% Confidence Interval|Median
830818|NCT01239992|Other Pre-specified|LDL-cholesterol|Percent change of LDL-cholesterol at 12 weeks compared to baseline|baseline and 12 weeks after treatment|||percentage change||Standard Deviation|Mean
830819|NCT01239992|Secondary|Fasting Triglycerides|Percent change of fasting triglycerides at 12 weeks compared to baseline|baseline and 12 weeks after treatment|||percentage change||Standard Deviation|Mean
830820|NCT01239992|Secondary|HDL Cholesterol|Percent change of HDL-cholesterol at 12 weeks compared to baseline.|baseline and 12 weeks after treatment|||percentage change||Standard Deviation|Mean
830821|NCT01239992|Primary|Incremental Area Under the Plasma Triglyceride Curve Over 8 Hours Following a Standardized Oral Fat Tolerance Test|Percent change of incremental AUC at 12 weeks compared to baseline.|baseline and 12 weeks after treatment|||percentage change||Standard Deviation|Mean
830822|NCT01240122|Secondary|Overall Ocular Comfort|All subjects were asked to rate their lens comfort at each visit based on an 11 point scale where 0 meant that the lens could not be tolerated and 10 indicated that the lens could not be felt.|Day 4|All subjects who completed the study were included in the analysis per protocol.||score on a scale||Standard Deviation|Mean
830823|NCT01240122|Secondary|Subjective Solution Preference|Subject asked which solution they prefer based on comfort level.|Day 4||||||
830824|NCT01240122|Primary|Corneal Staining by Wear Time|All participants were contact lenses wearers and were evaluated with a Corneal Staining at 1 hour, 2 hours, 4 hours and end of day. The corneal staining test is performed using fluorescein drops in the eye and ultraviolet illumination to determine if there has been any damage to the cornea from the use of the lens solutions or from the use of the contact lens.|1 hour on Day 1, 2 hours on Day 2, 4 hours on Day 3 and End of Day on Day 4|Corneal Staining Severity at Scheduled Visits (Safety Population)||participants|||Number
830825|NCT01240135|Secondary|Mean Change From Baseline for Circumlimbal Conjunctival Staining Sum Score|The bulbar conjunctiva was assessed by the investigator at baseline and Day 14 utilizing a slit-lamp and ophthalmic dye. Staining coverage was scored separately in each of four regions (nasal, temporal, inferior, and superior) using a 5-point photographic reference scale, where 0=0.00% coverage and 4=10% or greater coverage. The scores for the four regions were summed, with a sum score range of 0-16.|Day 14 of lens wear|Intent to treat: All randomized subjects with at least one post-baseline assessment after dispensing, according to randomized treatment.||units on a scale||Standard Deviation|Mean
830826|NCT01240135|Primary|Lens Fit|As assessed by the investigator using a composite score based on three lens fit measures: static, push-up, and centration. Static and pushup were assessed on a 5-point scale, where -2=reduced movement unacceptable, -1=reduced movement acceptable, 0=optimal movement, 1=excessive movement acceptable, 2=excessive movement unacceptable. Centration was assessed on a 3-point scale, where 0=optimal lens centration, 1=acceptable decentration, 2=unacceptable decentration. A subject with an assessment of optimal or acceptable for each measure was considered acceptable on all measurements.|Day 14 of lens wear|Intent to treat: All randomized subjects with at least one post-baseline assessment after dispensing, according to randomized treatment.||percentage of acceptable fit|||Number
830827|NCT01240200|Secondary|Blood Glucose (Low Blood Glucose)|"Secondary outcomes include differences between treatment regimens in any of the following measures:
Number of episodes of nocturnal hypoglycemia, any hypoglycemia, severe hypoglycemia
Accuracy of insulin dosing at weeks 0,12 and 24"|at 24 weeks||||||
830828|NCT01240200|Secondary|Blood Glucose (Low Blood Glucose)|"Secondary outcomes include differences between treatment regimens in any of the following measures:
Number of episodes of nocturnal hypoglycemia, any hypoglycemia, severe hypoglycemia
Accuracy of insulin dosing at weeks 0,12 and 24"|at 24 weeks||||||
830829|NCT01240200|Secondary|Blood Glucose (Low Blood Glucose)|"Secondary outcomes include differences between treatment regimens in any of the following measures:
Number of episodes of nocturnal hypoglycemia, any hypoglycemia, severe hypoglycemia
Accuracy of insulin dosing at weeks 0,12 and 24"|at 12 weeks||||||
830830|NCT01240200|Secondary|Blood Glucose Control|Percent of subjects with A1c <7.0% without hypoglycemia, A1c and mean fasting blood glucose at the end of each 12 week treatment period and percent with mean fasting glucose <130 mg/dL without hypoglycemia|at 12 weeks||||||
830831|NCT01240200|Secondary|Blood Glucose Control|"Secondary outcomes include differences between treatment regimens in any of the following measures:
Number of episodes of nocturnal hypoglycemia, any hypoglycemia, severe hypoglycemia
Accuracy of insulin dosing at weeks 0,12 and 24"|at 0 weeks||||||
830832|NCT01240200|Secondary|Blood Glucose Control|"Secondary outcomes include differences between treatment regimens in any of the following measures:
Percent of subjects with A1c <7.0% without hypoglycemia, A1c and mean fasting blood glucose at the end of each 12 week treatment period and percent with mean fasting glucose <130 mg/dL without hypoglycemia"|at 0 weeks||||||
830838|NCT01240330|Primary|Change in Femoral Venous Peak Flow Velocity Compared to Resting Baseline|The femoral vein in the mid-thigh area was located and the femoral venous Peak Flow Velocity (PFV)was measured using duplex ultrasound during the compression phase of treatment. PFV is the maximum velocity of blood flow achieved when the foot and calf compression is applied. The PFV was then compared to the subject's own baseline PFV using a paired t-test.|3 measurements/10 min. therapy|||cm/s||95% Confidence Interval|Mean
830839|NCT01240356|Primary|Number of Participants in Phase I Group With Neurological Deterioration as Measured by Neurological Examination|The neurological examinations comprised assessments of mental status and orientation, cranial nerve examination, muscle strength and tone, deep tendon reflexes, sensory testing, coordination, and gait.|2-3 hours after treatment|||participants|||Number
830840|NCT01240356|Secondary|Percentage of Participants in Phase II Group With Excellent Outcome as Measured by Modified Rankin Scale (mRS)|A modified Rankin Scale (mRS) score of 0 or 1 indicates an excellent outcome. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The mRS scale ranks patients from 0 to 6 (0 is the best score, 6 is the worst score).|at 3-months from enrollment|ITT with modified Ranking scores (mSR) at 90 days. % displayed is % with excellent outcome (mRS of 0-1).||percentage of patients||95% Confidence Interval|Number
830841|NCT01240356|Secondary|Percentage of Participants in Phase II Group With Neurological Worsening as Determined by the NIH Stroke Scale|The National Institutes of Health Stroke Scale, or NIH Stroke Scale (NIHSS) is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke. Each item on the NIHSS scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.|within 90 days of enrollment|||percentage of patients||95% Confidence Interval|Number
830842|NCT01240356|Secondary|Percentage of Participants in the Phase II Group That Show Arterial Recanalization as Measured Using Standard Transcranial Doppler Ultrasound Systems|Ischemic stroke patients: 2-hour rates of arterial complete and partial recanalization as measured using standard Transcranial Doppler Ultrasound systems.|2-3 hours after treatment|ITT - Percent of patients who had complete recanalization after treatment.||percentage of patients||95% Confidence Interval|Number
830843|NCT01240356|Secondary|Number of Participants in Phase I Group With Adverse Events During and After Study Treatment With HF TCD|Phase I - A group of healthy volunteers will be assessed to determine the feasibility and activity of hands-free (HF) transcranial Doppler (TCD). Adverse events include subject complaints regarding discomfort of the device and dermatological adverse events as evidenced by a detailed physical examination of skin integrity post-insonation.|2-3 hours after treatment|ITT||participants|||Number
830844|NCT01240356|Primary|Safety in Phase II Group as Measured by Incidence of Symptomatic Intracerebral Hemorrhage|Phase II: Determine if the Hands-Free TCD will not result in higher than 10% rate of symptomatic intracerebral hemorrhage (ICH) within 24 hours (defined as clinical worsening > 4 NIH Stroke Scale (NIHSS) points and presence of hemorrhage on CT scan that in the opinion of the treating physician is causatively related to ICH on CT) in 0-3 hours acute stroke patients treated with intravenous tissue-type plasminogen activator (IV-t-PA).|within 24 hours|Intention to Treat (ITT)||percentage of patients||95% Confidence Interval|Number
830845|NCT01240356|Primary|Number of Participants in Phase I Group With Blood-brain-barrier Disruption (BBB) as Measured by MRI of the Brain|Phase I : Imaging of the brain via MRI scans was performed to determine if the Hands-Free transcranial Doppler (TCD) system results in any BBB-disruption or deterioration in permeability.|2-3 hours after treatment|||participants|||Number
830846|NCT01240382|Primary|Mean Change in Rose Bengal Staining Score From Baseline|"Rose bengal staining were scored according to the protocol by Shimmura et al. The ocular surface was divided into 5 zones: nasal and temporal conjunctival, and upper, middle, and lower corneal areas. A staining score between 0 and 3 points was used in each zone, with the minimum and maximum total staining scores ranging between 0 and 15 points.0 is better.
The degree of staining with Rose bengal dyes was scored as follows: 0 = no staining, 1= staining of less than half of the area, 2= staining of more than half of the area, 3= staining in the whole area."|Baseline and 4-week (discontinued (LOCF))|Efficacy analysis was performed full analysis set (FAS). In 0.1% sodium hyaluronate ophthalmic solution group, 2 subjects were excluded from analysis because there was no available efficacy data in rose bengal staining.||points||Standard Deviation|Mean
830847|NCT01240382|Primary|Mean Change in Fluorescein Staining Score From Baseline|"Fluorescein staining was scored according to the protocol by Shimmura et al. The cornea was divided into 3 equal zones: upper, middle, and lower. Each zone had a staining score ranging between 0 and 3 points, with minimum and maximum total staining scores ranging between 0 and 9 points. 0 is better.
The degree of staining with Fluorescein dyes was scored as follows: 0 = no staining, 1= staining of less than half of the area, 2= staining of more than half of the area, 3= staining in the whole area."|Baseline and 4-week (discontinued (LOCF))|Efficacy analysis was performed full analysis set (FAS). In 0.1% sodium hyaluronate ophthalmic solution group, 1 subject was excluded from analysis because there was no available efficacy data in fluorescein staining.||points||Standard Deviation|Mean
830848|NCT01240551|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events, see the adverse event module.|52.5 months|||participants|||Number
830849|NCT01240551|Primary|Number of Participants With Present or Not Present Bone Metastasis|Present and not present bone metastasis was determined by sodium fluoride (NaF) PET (positron emission imaging)/CT (computed tomography) imaging. Present bone metastasis is defined as greater than normal bone uptake. Not present bone metastasis is defined as physiological bone uptake of F-18 NaF on PET/CT imaging (i.e. excluding traumatic and degenerative foci of increased F-18 NaF uptake.|Single imaging sessions will be acquired at baseline, between 4-6 months and between 10-12 months on emolument.|Patient with known prostate cancer. One group with known metastatic bone disease, based on prior clinical imaging scan (Tc-99m bone scan or NaF-18 bone scan or CT, and a second group with clinical risk factors for obtaining bony metastatic disease (i.e. pelvic soft tissue mets, high PSA (prostate specific antigen) blood levels).||participants|||Number
830850|NCT01240590|Secondary|Tumor Growth Rate Constant|Difference in time (days) required for the treated tumors to reach a predetermined target size.|21 days|This outcome measure was not analyzed because few if any re-assessments were done, thus there was not enough data to assess the growth rate constant on the patients.|||||
830851|NCT01240590|Secondary|Number of Participants Who Underwent Medically-Necessary Interventions|Enrolled participants who had surgical procedures deemed medically necessary for their clinical care.|4.5 years|||Participants|||Count of Participants
830852|NCT01240590|Primary|Number of Participants With Serious and Non-Serious Adverse Events (Phase I & II)|Here is the number of participants with serious and non-serious adverse events. For a detailed list of adverse events, see the adverse event module.|4 years, 6 months and 26 days|||participants|||Number
830853|NCT01240590|Primary|Progression Free Survival (Phase II)|Progression free survival (PFS) is defined as the duration of time from start of study treatment to time of progression. Response is determined by the Response Evaluation Criteria in Solid Tumors (RECIST) and is defined as: Complete Response (CR) is disappearance of all target lesions; Partial Response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; and stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|6 weeks|The outcome was not met because the patients died and were not scanned before their death.|||||
830854|NCT01240590|Primary|Maximum Tolerated Dose (MTD) of Crolibulin (Phase I)|MTD is defined as the dose level immediately preceding the dose level at which 2 dose limiting toxicities (DLT) occurred. A DLT is defined as a hematologic or non-hematologic adverse event judged to be possibly, probably, or definitely related to cisplatin per the Common Terminology Criteria in Adverse Events (CTCAE).|3 weeks|||mg/m^2|||Number
830855|NCT01240590|Primary|Maximum Tolerated Dose (MTD) of Cisplatin (Phase I)|MTD is defined as the dose level immediately preceding the dose level at which 2 dose limiting toxicities (DLT) occurred. A DLT is defined as a hematologic or non-hematologic adverse event judged to be possibly, probably, or definitely related to cisplatin per the Common Terminology Criteria in Adverse Events (CTCAE).|3 weeks|||mg/m^2|||Number
830856|NCT01240746|Other Pre-specified|Number of Participants Aged 3 Years to <9 Years Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines|Solicited injection site reactions: Pain, Redness, and Swelling. Solicited systemic reactions: Fever (Temperature); Headache, Malaise and Myalgia Grade 3 Pain: incapacitating, unable to perform usual activities; Redness and Swelling: ≥ 50 mm; Fever: ≥ 102.1°F; Headache, Malaise and Myalgia: Significant, prevents daily activity, respectively.|Day 0 up to Day 7 post-vaccination|Safety profile were assessed in all randomized and vaccinated participants, safety population. Values presented for participants aged 3 years to <9 years with available data for the relevant endpoint.||Participants|||Number
830857|NCT01240746|Other Pre-specified|Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines.|"Solicited injection site reactions (Age 6-23 Months): Tenderness, Erythema and Swelling. Solicited systemic reactions: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of appetite, and Irritability.
Grade 3: Tenderness: cries when injected limb is moved; Erythema and Swelling ≥ 50 mm; Fever: >103.1°F; Vomiting: ≥6 episodes/24 hours; Abnormal crying: >3 hours; Drowsiness: Sleeping most of the time; Loss of appetite: refuses ≥3 feeds/meals or most feeds/meals; Irritability: inconsolable.
Solicited Injection site reactions (Age 24 Months to < 36 months): Pain, Erythema, and Swelling. Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia.
Grade 3: Pain: Incapacitating, unable to perform usual activities; Redness and Swelling: ≥ 50 mm; Fever: ≥102.1°F; Headache, Malaise and Myalgia: Significant, prevents daily activity."|Day 0 up to Day 7 post-vaccination|Safety profile were assessed in all randomized and vaccinated participants, safety population. Values presented for participants aged 6 months to <36 months with available data for the relevant endpoint.||Participants|||Number
830858|NCT01240746|Primary|Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 3 Years to Less Than 9 Years.|Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.|Day 28 post-vaccination|Geometric mean titers to influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population. Data presented for participants aged 3 years to less than 9 Years with valid serology results for the particular antigen.||Titers||95% Confidence Interval|Geometric Mean
830859|NCT01240746|Other Pre-specified|Seroprotection Against Influenza Vaccine Antigens After Vaccination With Two Doses of Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants|"Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.
Seroprotection was defined as a pre-vaccination and post-vaccination titer ≥ 40 (l/dil)."|Day 28 post final vaccination|Seroprotection against influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population. Data presented for participants with valid serology results for the particular antigen.||Participants|||Number
830860|NCT01240746|Other Pre-specified|Seroprotection Against Influenza Vaccine Antigens After Vaccination With One Dose of Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants|"Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.
Seroprotection was defined as a pre-vaccination and post-vaccination titer ≥ 40 (l/dil)."|Day 28 post-vaccination|Seroprotection against influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population. Data presented for participants with valid serology results for the particular antigen.||Participants|||Number
830861|NCT01240746|Other Pre-specified|Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 3 Years to Less Than 9 Years.|"Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.
Seroprotection was defined as a pre-vaccination and post-vaccination titer ≥ 40 (l/dil)."|Day 28 post-vaccination|Seroprotection against influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population. Data presented for participants aged 3 years to less than 9 years with valid serology results for the particular antigen.||Participants|||Number
830862|NCT01240746|Other Pre-specified|Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 6 Months to Less Than 36 Months.|"Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.
Seroprotection was defined as a pre-vaccination and post-vaccination titer ≥ 40 (l/dil)."|Day 28 post final vaccination|Seroprotection against influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population. Data presented for participants aged 6 months to less than 36 months with valid serology results for the particular antigen.||Participants|||Number
830863|NCT01240746|Other Pre-specified|Seroconversion Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines Without Corresponding B Strain in All Participants.|"Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.
Seroconversion was defined as either a pre vaccination HAI titer <1:10 and a post vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and a four-fold increase in post-vaccination."|Day 28 post final vaccination|Seroconversion with respect to influenza vaccine B antigens (cross-reactive antibody) was determined in randomized and vaccinated participants, per-protocol population. Data presented for participants with valid serology results for the B antigens.||Participants|||Number
830864|NCT01240746|Primary|Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 6 Months to Less Than 36 Months.|Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.|Day 28 post final vaccination|Geometric mean titers to influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population. Data presented for participants aged 6 months to less than 36 months with valid serology results for the particular antigen.||Titers||95% Confidence Interval|Geometric Mean
830865|NCT01240746|Other Pre-specified|Seroconversion Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants|"Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.
Seroconversion was defined as either a pre vaccination HAI titer <1:10 and a post vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and a four-fold increase in post-vaccination."|Day 28 post final vaccination|Seroconversion with respect to vaccine antigens (cross-reactive antibody) were determined in randomized and vaccinated participants, per-protocol population. Data presented for participants with valid serology results for the particular antigen.||Participants|||Number
830866|NCT01240746|Other Pre-specified|Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants|"Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.
Seroprotection was defined as a pre-vaccination and post-vaccination titer ≥ 40 (l/dil)"|Day 28 post final vaccination|Seroprotection against influenza vaccine antigens was determined in randomized and vaccinated participants, per-protocol population. Data presented for participants with valid serology results for the particular antigen.||Participants|||Number
830867|NCT01240746|Primary|Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines Without Corresponding B Strain in All Participants|Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.|Day 28 post final vaccination|Geometric mean titers to influenza vaccine B antigens (cross-reactive antibody) were determined in randomized and vaccinated participants, per-protocol population. Data presented for participants with valid serology results for the B antigen.||Titers||95% Confidence Interval|Geometric Mean
830868|NCT01240746|Primary|Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines With Corresponding B Strain in All Participants|Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.|Day 28 post final vaccination|Geometric mean titers to influenza vaccine B antigens were determined in randomized and vaccinated participants, per-protocol population. Data presented for participants with valid serology results for the B antigen.||Titers||95% Confidence Interval|Geometric Mean
830869|NCT01240746|Other Pre-specified|Seroconversion Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines With Corresponding B Strain in All Participants|"Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.
Seroconversion was defined as either a pre-vaccination HAI titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and ≥four-fold increase in post-vaccination"|Day 28 post final vaccination|Seroconversion with respect to influenza vaccine B antigens were determined in randomized and vaccinated participants, per-protocol population||Participants|||Number
830870|NCT01240746|Primary|Geometric Mean Titers Against Influenza A Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants|Immunogenicity outcomes were assessed in serum samples by hemagglutination inhibition (HAI) assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.|Day 28 post final vaccination|Geometric mean titers (GMT) to influenza vaccine A antigens were determined in randomized and vaccinated participants, per-protocol population. The GMT data for antigen A/Victoria/210/2009 and A/California/07/2009 were pooled for participants vaccinated with either 2010-2011 TIV or the investigational TIV. Data presented in column for Group 1.||Titers||95% Confidence Interval|Geometric Mean
830871|NCT01240785|Secondary|Child Outcome at 2 Years Per Arm|neuropsychological and motor skills testing|2 years after birth||||||
830872|NCT01240785|Secondary|Neonate Transfer to Intensive Care Unit Per Arm||0-5 days after delivery|||participants|||Number
830873|NCT01240785|Secondary|Apgar Score at 5 Min After Delivery Per Arm|Apgar score 0-10. 0-2 points from heart rate; 0-2 points for respiratory effort; 0-2 points for skin colour; 0-2 points for muscle tone; 0-2 points for reflex response. For all items the higher the value, the better the outcome|5 minutes after delivery|||units on a scale||Standard Deviation|Mean
830874|NCT01240785|Secondary|Neonatal Hyperbilirubinemia Per Arm||0-3 days after delivery|||participants|||Number
830875|NCT01240785|Secondary|Neonatal Hypoglycemia Per Arm||0-24 h after delivery|||participants|||Number
830876|NCT01240785|Secondary|Shoulder Dystocia Per Arm||delivery|||participants|||Number
830877|NCT01240785|Secondary|Induction of Delivery Per Arm||delivery|||participants|||Number
830878|NCT01240785|Secondary|Gestational Weeks at Delivery Per Arm||delivery|||weeks||Standard Deviation|Mean
830879|NCT01240785|Secondary|Mode of Delivery Per Arm||delivery|||no of cesarean section|||Number
830880|NCT01240785|Secondary|Pre-eclampsia Per Arm||up to on the average 40 weeks of gestation|||participants|||Number
830881|NCT01240785|Secondary|Maternal Weight Gain Per Arm||up to on the average 40 weeks of gestation|||kg||Standard Deviation|Mean
830882|NCT01240785|Secondary|Pregnancy Induced Hypertension Per Arm|Participants with pregnancy induced hypertension defined as blood pressure over 140/90 mmHg or increase in systolic blood pressure > 30 mmHg or diastolic blood pressure > 15 mmHg|up to on the average 40 weeks of gestation|||participants|||Number
830883|NCT01240785|Primary|Birth Weight Per Arm|birth weight adjusted for gestational weeks expressed as standard deviation units using data from Finnish fetal growth charts in normal pregnancies|delivery|||g||Standard Deviation|Mean
830884|NCT01240811|Secondary|Vaginal and Endometrial Flora|Changes in vaginal and endometrial flora as assessed by qualitative and quantitative culture|2 Months||||||
830885|NCT01240811|Primary|%CD4 Expressing CCR5 HIV Co-receptor in the Cervix and Endometrium|Change in CCR5 expression on T-lymphocytes 2 months after insertion of IUD (either hormonal LNG-IUD or non-hormonal Cu-IUD) in cervix and endometrium as measured by flow cytomety|2 months|All 40 participants who completed the study were included in the analysis. There were no lost-to-follow up participants. One participant withdrew and one participant was excluded post-enrollment. Both of these participants were replaced to fill our goal enrollment of 40 participants in the study.||% of T-cells expressing CCR5||Standard Deviation|Mean
830886|NCT01240863|Secondary|Change From Baseline to Endpoint in the Double-Blind Treatment Phase in Electrocardiogram (ECG) Parameters|A 12-lead ECG was conducted at baseline and the last visit during the double-blind treatment period (week 12, or early termination).|Baseline (end of Open-Label Titration Period), Endpoint (last visit up to Week 12) of the Double-blind treatment period|FAS of participants contributing baseline and endpoint data.||msec||Standard Deviation|Mean
830887|NCT01240863|Secondary|Current Opioid Misuse Measures (COMM) Total Scores During Both the Open-Label Titration and Double-Blind Treatment Periods|"The COMM was a clinician rated scale developed as a brief self report measure of current aberrant drug-related behavior for patients with chronic pain who were already on long term opioid therapy. A total score was calculated as the sum of the 17 questions. The total score ranged from 0 to 68. A score of 0 indicates no aberrant drug-related behaviors were seen. Patients with a total score of 9 or greater were classified as exhibiting aberrant drug-related behavior.
The COMM was to be performed at visits 2 and 7 (beginning and end of Open-label Titration period) and weeks 1, 4, 8, and 12 (Double-blind Treatment period) or early termination."|Baseline for Open-Label Titration period, Baseline for Double-Blind Treatment period (which is also the end of the Open-Label Titration period), Weeks 1, 4, 8, 12, and Endpoint (last visit up to Week 12) of the Double-blind Treatment period|Full analysis set. Participants contributing to each time point are included in the number analyzed.||units on a scale||Standard Deviation|Mean
830888|NCT01240863|Secondary|Addiction Behavior Checklist (ABC) Total Scores During Both the Open-Label Titration and Double-Blind Treatment Periods|"The ABC was a clinician rated scale that consisted of a brief (20 item) questionnaire designed to track behaviors characteristic of addiction related to prescription opioid medications in chronic pain populations. Items were focused on observable behaviors noted both during and between clinic visits. Each affirmative response was counted as one point, and points were added to calculate the total score, consequently resulting in scores ranging from 0 to 20 (0=no addiction-related behaviors seen and higher scores indicating an increasing number of addition-related behaviors seen).
The ABC was to be performed at visits 2 and 7 (beginning and end of Open-label Titration period) and weeks 1, 4, 8, and 12 (Double-blind Treatment period) or early termination."|Baseline for Open-Label Titration period, Baseline for Double-Blind Treatment period (which is also the end of the Open-Label Titration period), Weeks 1, 4, 8, 12, and Endpoint (last visit up to Week 12) of the Double-blind Treatment period|Full analysis set. Participants contributing to each time point are included in the number analyzed.||units on a scale||Standard Deviation|Mean
831184|NCT01244490|Secondary|Clinical Global Impression-Severity of Illness (CGI-S) - LOCF|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill). Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.|Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years|Full Analysis Set. Not all subjects in the FAS population had data for this outcome.||percentage of participants|||Number
830889|NCT01240863|Secondary|Clinical Opiate Withdrawal Scales (COWS) Scores During the Double-Blind Treatment Period|"The COWS was a clinician rated scale used to measure a participant’s signs and symptoms of withdrawal from opiates, with ratings based only on apparent relationship to withdrawal. The COWS was performed at day 0 and weeks 1, 2, 4, 8, and 12 (double blind treatment period) or early termination. The scale contained 11 signs/symptoms whose intensity the clinician rated on a scale of 0 to 4 or 5.
A total score was calculated as the sum of the responses to the 11 signs/symptoms for a total range of 0-48. Withdrawal severity was classified, based on the total score, as follows:
0 to 4=normal
5 to 12=mild
13 to 24=moderate
25 to 36=moderately severe
>36=severe"|Baseline (end of Open-Label Titration Period), Weeks 1, 2, 4, 8, 12 and Endpoint (last visit up to Week 12) of the Double-blind treatment period|Full analysis set. Participants contributing to each time point are included in the number analyzed.||units on a scale||Standard Deviation|Mean
830890|NCT01240863|Secondary|Subjective Opiate Withdrawal Scales (SOWS) Scores During the Double-Blind Treatment Period|The results of the SOWS were collected in the e-diary daily during the first 4 weeks of the double blind treatment period and then during clinic visits at weeks 8 and 12 or early termination. The SOWS was a self administered questionnaire used to measure a participant’s signs and symptoms of withdrawal from opiates. The scale contained 16 symptoms (eg, my nose is running; I feel restless), the participant rated the intensity on a scale of 0 (not at all) to 4 (extremely) for a total score of 0-64. The daily total score for the first 4 weeks was the largest score observed during the time period preceding that visit. For example, the week 1 score for each participant was the largest total score on any day between baseline and the night before the week 1 visit; the week 4 score for each participant was the largest score observed between the week 2 visit and the night before the week 4 visit.|Weeks 1, 2, 4, 8, 12 and Endpoint (last visit up to Week 12) of the Double-blind treatment period|Full analysis set. Participants contributing to each time point are included in the number analyzed.||units on a scale||Standard Deviation|Mean
830891|NCT01240863|Secondary|Participants With Potentially Clinically Significant Abnormal Laboratory Values During the Double-Blind Treatment Period|"Data represents participants with potentially clinically significant abnormal serum chemistry, hematology and urinalysis values.
Significance criteria:
Blood urea nitrogen: >=10.71 mmol/L
Uric acid: M>=625, F>=506 μmol/L
Hemoglobin: M<=115, F<=95 g/dL
Hematocrit: M<0.37, F<0.32 %
Urinalysis: blood (hemoglobin) and total protein: >=2 unit increase from baseline"|Day 1 up to Day 128 in Double-Blind Treatment period|Full analysis set including participants with laboratory assessments||Participants|||Count of Participants
830892|NCT01240863|Secondary|Participants With Potentially Clinically Significant Abnormal Vital Signs Values During the Double-Blind Treatment Period|"Data represents participants with potentially clinically significant (PCS) vital sign values.
Significance criteria
Pulse - high: >=120 and increase of >= 15 beats/minute from baseline
Pulse - low: <=50 and decrease of >=15 beats/minute
Systolic blood pressure - high: >=180 and increase >=20 mmHg
Systolic blood pressure - low: <=90 and decrease >=20 mmHg
Diastolic blood pressure - high: >=105 and increase of >=15 mmHg
Diastolic blood pressure - low: <=50 and decrease of >=15 mmHg"|Day 1 up to Day 128 in Double-Blind Treatment period|FAS||Participants|||Count of Participants
830893|NCT01240863|Secondary|Participants With Adverse Events|An adverse event (AE) was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an inability to carry out usual activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 up to Day 52 in Open-Label Titration; Day 1 up to Day 128 in Double-Blind Treatment period|Safety analysis set (Open-Label Titration) and FAS (Double-Blind Treatment)||Participants|||Count of Participants
830894|NCT01240863|Secondary|Brief Pain Inventory – Short Form (BPI-SF) Pain Interference Mean Score During the Double-Blind Treatment Period|For pain interference, the BPI-SF used numerical scales to measure how much pain had interfered with 7 daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep in the past 24 hours. The scale used an 11 point Likert scale; range: 0 [does not interfere] to 10 [completely interferes]. BPI pain interference was typically scored as the mean of the 7 interference items. This mean could be used if at least 4 of 7 items had been completed on a given administration.|Baseline (end of Open-Label Titration Period), Weeks 1, 2, 4, 8, 12 and Endpoint (last visit up to week 12) of the Double-blind treatment period|Full analysis set. Participants contributing to each time point are included in the number analyzed.||units on a scale||Standard Deviation|Mean
830895|NCT01240863|Secondary|Short-Form Health Survey (SF-36) Physical and Mental Component Summary Scores at Baseline, Week 12 and Endpoint|SF-36 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: physical component summary (PCS) and mental component summary (MCS). The SF-36 consists of 8 subscales. The PCS is represented by 4 subscales: physical function, role limitations due to physical problems, pain, and general health perception. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). PCS and MCS scores are constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score; higher scores indicate better health status.|Baseline (end of Open-Label Titration Period), Week 12 and Endpoint (last visit up to week 12) of the Double-blind treatment period|Full analysis set. Participants contributing to each time point are included in the number analyzed.||units on a scale||Standard Deviation|Mean
830935|NCT01240915|Secondary|Change From Baseline in Total Mayo Scores at Week 8|Mayo Score is an instrument designed to measure disease activity of ulcerative colitis, with total score ranging from 0 to 12. It consists of 4 subscores (stool frequency, rectal bleeding, findings of flexible proctosigmoidoscopy, and physician global assessment [PGA]), each graded from 0 to 3, with higher scores indicating more severe disease.|Baseline, Week 8|The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint; n=the number of participants analyzed at that time point in the respective arms.||scores on a scale||Standard Deviation|Mean
830896|NCT01240863|Secondary|Clinician Global Impression of Severity (CGI-S) of Illness Scores During the Double-blind Treatment Period|"The CGI-S is a clinician-rated scale that assesses the severity of the patient’s pain condition and response to the treatment. Severity of illness, as related to moderate to severe pain, consists of the following 7 categories:
1 normal–shows no sign of illness,
2 borderline ill,
3 mildly (slightly) ill,
4 moderately ill,
5 markedly ill,
6 severely ill, and
7 among the most extremely ill (Guy 1976).
The clinician assesses the severity of the patient’s condition, based on the clinician’s total clinical experience with patients with this condition, in response to treatment.
Endpoint values are the last observed postbaseline data."|Baseline (end of Open-Label Titration Period), Weeks 1, 2, 4, 8, and 12 of the Double-blind treatment period|Full analysis set. Participants contributing to each time point are included in the number analyzed.||units on a scale||Standard Deviation|Mean
830897|NCT01240863|Secondary|Patient Assessment of Function (PAF) at Endpoint|"The PAF is a self-administered questionnaire used to measure patients’ assessment of their own ability to function in normal activities. Answers to the 7 questions were rated on a 7 point scale in which 1 was very much worsened and 7 were very much improved since the start of the study.
The seven functional areas are:
ability to go to work
ability to perform at work (includes both work outside the home and housework)
ability to walk
ability to exercise
ability to participate in social events
ability to have sex
ability to enjoy life
Endpoint values are the last observed postbaseline data."|Endpoint of the Double-blind Treatment Period (up to week 12)|Full analysis set. Participants contributing to each time point are included in the number analyzed.||Participants|||Count of Participants
830898|NCT01240863|Secondary|Patient Assessment of Function (PAF) at Week 12|"The PAF is a self-administered questionnaire used to measure patients’ assessment of their own ability to function in normal activities. Answers to the 7 questions were rated on a 7 point scale in which 1 was very much worsened and 7 were very much improved since the start of the study.
The seven functional areas are:
ability to go to work
ability to perform at work (includes both work outside the home and housework)
ability to walk
ability to exercise
ability to participate in social events
ability to have sex
ability to enjoy life"|Week 12 of the Double-blind Treatment Period|Full analysis set. Participants contributing to each time point are included in the number analyzed.||Participants|||Count of Participants
830899|NCT01240863|Secondary|Patient Assessment of Function (PAF) at Week 8|"The PAF is a self-administered questionnaire used to measure patients’ assessment of their own ability to function in normal activities. Answers to the 7 questions were rated on a 7 point scale in which 1 was very much worsened and 7 were very much improved since the start of the study.
The seven functional areas are:
ability to go to work
ability to perform at work (includes both work outside the home and housework)
ability to walk
ability to exercise
ability to participate in social events
ability to have sex
ability to enjoy life"|Week 8 of the Double-blind Treatment Period|Full analysis set. Participants contributing to each time point are included in the number analyzed.||Participants|||Count of Participants
830900|NCT01240863|Secondary|Patient Assessment of Function (PAF) at Week 4|"The PAF is a self-administered questionnaire used to measure patients’ assessment of their own ability to function in normal activities. Answers to the 7 questions were rated on a 7 point scale in which 1 was very much worsened and 7 were very much improved since the start of the study.
The seven functional areas are:
ability to go to work
ability to perform at work (includes both work outside the home and housework)
ability to walk
ability to exercise
ability to participate in social events
ability to have sex
ability to enjoy life"|Week 4 of the Double-blind Treatment Period|Full analysis set. Participants contributing to each time point are included in the number analyzed.||Participants|||Count of Participants
830901|NCT01240863|Secondary|Clinician Assessment of Patient Function (CAPF) at Endpoint|"Clinicians assessed participants across 5 dimensions:
Patients general activities
Patients walking ability
Patients ability to work/perform activities of daily living
Patients relationships with others
Patients enjoyment of life
Assessments are rated on a 7-point scale, in which 1 is very much worsened and 7 is very much improved since the start of the study.
Endpoint values are the last observed postbaseline data."|Endpoint of the Double-blind Treatment Period (up to week 12)|FAS of participants with assessments at the timeframe||Participants|||Count of Participants
830902|NCT01240863|Secondary|Clinician Assessment of Patient Function (CAPF) at Week 12|"Clinicians assessed participants across 5 dimensions:
Patients general activities
Patients walking ability
Patients ability to work/perform activities of daily living
Patients relationships with others
Patients enjoyment of life
Assessments are rated on a 7-point scale, in which 1 is very much worsened and 7 is very much improved since the start of the study."|Week 12 of the Double-blind Treatment Period|FAS of participants with assessments at the timeframe||Participants|||Count of Participants
830903|NCT01240863|Secondary|Clinician Assessment of Patient Function (CAPF) at Week 8|"Clinicians assessed participants across 5 dimensions:
Patients general activities
Patients walking ability
Patients ability to work/perform activities of daily living
Patients relationships with others
Patients enjoyment of life
Assessments are rated on a 7-point scale, in which 1 is very much worsened and 7 is very much improved since the start of the study."|Week 8 of the Double-blind Treatment Period|FAS of participants with assessments at the timeframe||Participants|||Count of Participants
830904|NCT01240863|Secondary|Clinician Assessment of Patient Function (CAPF) at Week 4|"Clinicians assessed participants across 5 dimensions:
Patients general activities
Patients walking ability
Patients ability to work/perform activities of daily living
Patients relationships with others
Patients enjoyment of life
Assessments are rated on a 7-point scale, in which 1 is very much worsened and 7 is very much improved since the start of the study."|Week 4 of the Double-blind Treatment Period|FAS of participants with assessments at the timeframe||Participants|||Count of Participants
830905|NCT01240863|Secondary|Weekly Average Worst Pain Intensity (WPI) Scores During the Double-blind Treatment Period|"The WPI was recorded by the patient in the e-diary daily throughout the study, based on the Numeric Rating Scale (NRS-11). Participants were asked to select the number that best described their WPI over the previous 24 hours. Values were averaged for each week.
The Numeric Rating Scale (NRS-11) is an 11–point scale for patient self-reporting of pain on a Likert-type scale in which 0 is no pain and 10 is the worst pain imaginable."|Baseline (end of Open-Label Titration Period), Weeks 1, 2, 4, 8, and 12 of the Double-blind treatment period|Full analysis set. Participants contributing to each time point are included in the number analyzed.||units on a scale||Standard Deviation|Mean
830906|NCT01240863|Secondary|Weekly Average Pain Intensity (wAPI) Scores During the Double-blind Treatment Period|"The API over the previous 24 hours, based on the 11-point Numerical Rating Scale (NRS 11), was collected daily by e-diary. The wAPI scores from the previous 7 days were calculated for each study visit and averaged. The baseline wAPI score was calculated by averaging API scores from 3 to 12 days when the successful dose of hydrocodone extended release was confirmed at the end of the open label titration period, before patients were randomly assigned study drug.
The Numeric Rating Scale (NRS-11) is an 11–point scale for patient self-reporting of pain on a Likert-type scale in which 0 is no pain and 10 is the worst pain imaginable."|Baseline (end of Open-Label Titration Period), Weeks 1, 2, 4, 8, and 12 of the Double-blind treatment period|Full analysis set. Participants contributing to each time point are included in the number analyzed.||units on a scale||Standard Deviation|Mean
830907|NCT01240863|Secondary|Participants With a Weekly Average Pain Intensity (wAPI) Increase From Baseline Exceeding 50%|"The API over the previous 24 hours, based on the 11-point Numerical Rating Scale (NRS 11), was collected daily by e-diary. The wAPI scores from the previous 7 days were calculated for each study visit and averaged. The baseline wAPI score was calculated by averaging API scores from 3 to 12 days when the successful dose of hydrocodone extended release was confirmed at the end of the open label titration period, before patients were randomly assigned study drug.
The Numeric Rating Scale (NRS-11) is an 11–point scale for patient self-reporting of pain on a Likert-type scale in which 0 is no pain and 10 is the worst pain imaginable."|Baseline (end of Open-Label Titration Period), Weeks 1, 2, 4, 8, and 12 of the Double-blind treatment period|Full analysis set. Participants contributing to each time point are included in the number analyzed.||Participants|||Count of Participants
830908|NCT01240863|Secondary|Participants With a Weekly Average Pain Intensity (wAPI) Increase From Baseline Exceeding 33%|"The API over the previous 24 hours, based on the 11-point Numerical Rating Scale (NRS 11), was collected daily by e-diary. The wAPI scores from the previous 7 days were calculated for each study visit and averaged. The baseline wAPI score was calculated by averaging API scores from 3 to 12 days when the successful dose of hydrocodone extended release was confirmed at the end of the open label titration period, before patients were randomly assigned study drug.
The Numeric Rating Scale (NRS-11) is an 11–point scale for patient self-reporting of pain on a Likert-type scale in which 0 is no pain and 10 is the worst pain imaginable."|Baseline (end of Open-Label Titration Period), Weeks 1, 2, 4, 8, and 12 of the Double-blind treatment period|Full analysis set. Participants contributing to each time point are included in the number analyzed.||Participants|||Count of Participants
830909|NCT01240863|Secondary|Kaplan-Meier Estimates for Time to Discontinuation From the Study|Kaplan-Meier estimates for time to discontinuation from the study (due to any cause) was calculated as the number of days since participants were randomly assigned to study drug treatment, ie, the difference between the date the participants withdrew and the date participants were randomly assigned to study drug treatment. The censoring flag was set to 0 if a participant was withdrawn from study drug treatment early and was set to 1 if the participant completed the 12 week treatment period. Censoring time was calculated as the difference of treatment completion date (ie, date of last study drug administration) and date participant was randomly assigned to study drug treatment.|Day 1 to Week 12 of the double-blind treatment period|Full analysis set||days||Inter-Quartile Range|Median
830910|NCT01240863|Secondary|Percentage of Participants Withdrawn From the Study During the Double-Blind Treatment Period By Reason|Percentage of participants who withdrew from the study during the double-blind treatment period. Withdrawal is due to any cause, including lack of efficacy.|Day 1 to Week 12 of the double-blind treatment period|Full analysis set||percentage of participants|||Number
830911|NCT01240863|Primary|Change From Baseline to Week 12 in Weekly Average Pain Intensity (wAPI)|"The primary efficacy variable was the change from baseline to week 12 in the wAPI. The API over the previous 24 hours, based on the 11-point Numerical Rating Scale (NRS 11), was collected daily by e-diary. The Week 12 wAPI scores from the previous 7 days were calculated for each study visit and averaged. The baseline wAPI score was calculated by averaging API scores from 3 to 12 days when the successful dose of hydrocodone extended release was confirmed at the end of the open label titration period, before patients were randomly assigned study drug. In the case of missing week-12 data due to early withdrawal from the study, or excessive rescue medication usage, the wAPI for week 12 was imputed.
The Numeric Rating Scale (NRS-11) is an 11–point scale for patient self-reporting of pain on a Likert-type scale in which 0 is no pain and 10 is the worst pain imaginable. Negative change from baseline values indicate lessening in pain intensity."|Baseline (end of Open-Label Titration Period), Week 12 of Double-blind Treatment Period|Full analysis set (FAS). One placebo patient was withdrawn from the study prior to receiving drug in the Double-blind Treatment period and is not included in the FAS. In the case of missing week-12 data due to early withdrawal from the study, or excessive rescue medication usage, the wAPI for week 12 was imputed.||units on a scale||Standard Error|Least Squares Mean
830932|NCT01240915|Secondary|Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16|Patient-reported diary data assessed the number of bowel movements (BM) per day when not having a flare and the presence of blood in the stools (rectal bleeding [RB]), if any.|Baseline and Week 16|The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint; n=the number of participants analyzed at that time point in the respective arms.||scores on a scale||Standard Deviation|Mean
830933|NCT01240915|Secondary|Change From Baseline in Biopsy Histology Scores at Week 8|A 15 to 25 centimeter (cm) biopsy sample of inflamed mucosal tissue was taken from the worst affected area and scored using the Riley Index. The Riley Index is a histologic scoring system for the assessment of the activity and severity of ulcerative colitis, ranging from 0 to 24. It consists of 6 histologic features (acute inflammatory cell infiltrate, crypt abscesses, mucin depletion, surface epithelial integrity, chronic inflammatory cell infiltrate, and crypt architectural irregularities), all scored on a 4-point scale (higher scores indicate more severe disease).|Baseline and Week 8|The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint; n=the number of participants analyzed at that time point in the respective arms.||scores on a scale||Standard Deviation|Mean
830934|NCT01240915|Secondary|Change From Baseline in Partial Mayo Scores at Weeks 4, 8, 12, and 16|Mayo Score is an instrument designed to measure disease activity of ulcerative colitis. Mayo Score ranges from 0 to 12 points. It consists of 4 subscores, each graded from 0 to 3 with higher scores indicating more severe disease. A Partial Mayo Score (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and PGA) with each ranging from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). Higher scores indicate more severe disease.|Baseline, Weeks 4, 8, 12 and 16|The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint; n=the number of participants analyzed at that time point in the respective arms.||scores on a scale||Standard Deviation|Mean
831320|NCT01245140|Secondary|Mean Heart Rate (HR) at Baseline, Screening, and EOT (Week 24)|HR is defined as the rate at which the heart beats.|Screening, Baseline, and EOT (Week 24)|Safety Population. Only participants available at the specified time points were analyzed (n=X, X).||Beats per minute (bpm)||Standard Deviation|Mean
830936|NCT01240915|Secondary|Percentage of Participants in Clinical Response at Week 8|Clinical response is defined as a decrease in total Mayo score from baseline of at least 3 points and at least 30 percent (%), with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore for rectal bleeding of 0 or 1.|Week 8|The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint.||percentage of participants|||Number
830937|NCT01240915|Secondary|Percentage of Participants With Endoscopic Response at Week 8|Endoscopic response is defined as a decrease in modified Baron endoscopic score from baseline of at least 2 points.|Week 8|The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint.||percentage of participants|||Number
830938|NCT01240915|Secondary|Percentage of Participants With Decrease From Baseline of at Least 1 Point in Rectal Bleeding Mayo Subscore at Weeks 4, 8, 12, and 16|Mayo subscores for rectal bleeding range from 0 to 3 (0=no blood seen; 1=streaks of blood with stool less than half the time; 2=obvious blood with stool most of the time; 3=blood alone passes). A decrease from baseline score indicates improvement.|Baseline, Weeks 4, 8, 12 and 16|The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint.||percentage of participants|||Number
830939|NCT01240915|Secondary|Percentage of Participants in Clinical Remission at Week 8|Clinical remission is defined as a total Mayo score of 2 points or lower, with no individual subscores exceeding 1 point.|Week 8|The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint.||percentage of participants|||Number
830940|NCT01240915|Secondary|Percentage of Participants in Endoscopic Remission at Week 8|Modified Baron Score is an instrument designed to measure endoscopic activity of ulcerative colitis. It classifies the mucosal inflammation in 4 grades (0=normal, 1=granular mucosa with an abnormal vascular pattern, 2=friable mucosa, 3=microulceration with spontaneous bleeding, 4=gross ulceration with spontaneous bleeding). Endoscopic remission is defined as modified Baron Endoscopic Score equal to 0.|Week 8|The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint.||percentage of participants|||Number
830941|NCT01240915|Secondary|Percentage of Participants With Rectal Bleeding Mayo Subscore of Zero at Weeks 4, 8, 12, and 16|Mayo subscores for rectal bleeding range from 0 to 3 (0=no blood seen; 1=streaks of blood with stool less than half the time; 2=obvious blood with stool most of the time; 3=blood alone passes).|Week 4, 8, 12 and 16|The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint.||percentage of participants|||Number
830942|NCT01240915|Secondary|Fold Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 8, 12, and 16|CRP is an acute-phase protein which provides an objective criterion of inflammatory activity. CRP has a short half-life (19 hours) and therefore rises early after the onset of inflammation and rapidly decreases after resolution of the inflammation. It is induced by interleukin-6, TNF-alpha and other pro-inflammatory cytokines that are produced within the intestinal lamina propria.|Baseline, Weeks 4, 8, 12 and 16|The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint; n=the number of participants analyzed at that time point in the respective arms.||fold change||Geometric Coefficient of Variation|Geometric Mean
830943|NCT01240915|Secondary|Fold Change From Baseline in Fecal Calprotectin at Weeks 4, 8, 12, and 16|Fecal calprotectin, a very stable marker, is a 36kDa calcium and zinc binding protein which is neutrophil-derived. It represents 60% of cytosolic proteins in granulocytes and is a measurement of neutrophil migration to the gastrointestinal tract.|Baseline, Weeks 4, 8, 12 and 16|The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint; n=the number of participants analyzed at that time point in the respective arms.||fold change||Geometric Coefficient of Variation|Geometric Mean
830944|NCT01240915|Secondary|Number of Participants With Potentially Clinically Significant Vital Signs Findings|Vital signs assessment included pulse rate, systolic blood pressure (SBP) and diastolic blood pressure (DBP). Criteria for vital sign values meeting potential clinical concern included: SBP <90 millimeters of mercury (mm Hg) and >=30 mm Hg increase/decrease from baseline, DBP <50 mm Hg and >=20 mm Hg increase/decrease from baseline, pulse rate <40 or >120 beats per minute (bpm),|Baseline up to Week 52|The safety analysis population consisted of all participants who received at least 1 dose of study medication.||participants|||Number
830945|NCT01240915|Secondary|Number of Participants With Laboratory Test Abnormalities|The total number of participants with laboratory test abnormalities with or without regard to baseline abnormality was assessed. Laboratory parameters included: hematology (hemoglobin, hematocrit, red blood cell [RBC] count, platelet count, white blood cell [WBC] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes, erythrocyte sedimentation rate); chemistry (blood urea nitrogen and creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein; urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, microscopy (only if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase); other (follicle-stimulating hormone, human chorionic gonadotropin, stool microbiology, creatinine kinase, direct bilirubin, indirect bilirubin, gamma-glutamyl transferase, international normalized ratio.|Baseline up to Week 24|The safety analysis population consisted of all participants who received at least 1 dose of study medication; n=the number of participants analyzed at that time point in the respective arms.||participants|||Number
831573|NCT01247272|Primary|AUC0-inf of Fluoxetine.|Bioequivalence based on Fluoxetine AUC0-inf (area under the concentration-time curve from time zero to infinity).|Blood samples collected over a 25 day period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
830946|NCT01240915|Secondary|Change From Baseline in Rectal Bleeding Mayo Subscore at Week 12 and Week 16|Mayo Score is an instrument designed to measure disease activity of ulcerative colitis. Mayo subscores for rectal bleeding range from 0 to 3, with higher scores indicating more severe disease.|Baseline, Week 12, Week 16|The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint; n=the number of participants analyzed at that time point in the respective arms.||scores on a scale||Standard Deviation|Mean
830947|NCT01240915|Primary|Number of Treatment-Emergent AEs by Severity|The intensity grades were defined as follows: mild=does not interfere with participant's usual function; moderate=interferes to some extent with participant's usual function; severe=interferes significantly with participant's usual function.|Baseline up to Week 52|The safety analysis population consisted of all participants who received at least 1 dose of study medication.||adverse events|||Number
830948|NCT01240915|Primary|Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC)||Baseline up to Week 52|The safety analysis population consisted of all participants who received at least 1 dose of study medication.||participants|||Number
830949|NCT01240915|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.|Baseline up to Week 52|The safety analysis population consisted of all participants who received at least 1 dose of study medication.||participants|||Number
830950|NCT01240915|Primary|Change From Baseline in Rectal Bleeding Mayo Subscore at Week 8|Mayo Score is an instrument designed to measure disease activity of ulcerative colitis. Mayo subscores for rectal bleeding range from 0 to 3, with higher scores indicating more severe disease.|Baseline and Week 8|The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint.||scores on a scale||Standard Deviation|Mean
830951|NCT01240915|Primary|Change From Baseline in Rectal Bleeding Mayo Subscore at Week 4|Mayo Score is an instrument designed to measure disease activity of ulcerative colitis. Mayo subscores for rectal bleeding range from 0 to 3, with higher scores indicating more severe disease.|Baseline and Week 4|The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint; n=the number of participants analyzed at that time point in the respective arms.||scores on a scale||Standard Deviation|Mean
830952|NCT01240915|Primary|Change From Baseline in Endoscopic Score (as Measured by Modified Baron Score) at Week 8|Modified Baron Score is an instrument designed to measure endoscopic activity of ulcerative colitis. It classifies the mucosal inflammation in 4 grades (0=normal, 1=granular mucosa with an abnormal vascular pattern, 2=friable mucosa, 3=microulceration with spontaneous bleeding, 4=gross ulceration with spontaneous bleeding).|Baseline and Week 8|The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint. Baseline observation carried forward (BOCF) was used for treatment failures.||scores on a scale||Standard Deviation|Mean
830953|NCT01241240|Secondary|Mean Worse Eye IOP|IOP is a measurement of the fluid pressure inside the eye. For each eye, the IOP was either the average of 2 measurements, or, if a third measurement was required, the median of the 3 measurements. The worse eye was determined based on the IOP results at Baseline. The mean worse eye IOP was the average of the IOP measurements of the worse eye at hours 0 and 2 at each time-point.|Weeks 1, 2, 4, 8 and 12|Participants from the mITT population, that included all randomized participants who had at least 1 post-baseline IOP measurement, with data available for analysis at the given time-point.||mmHg||Standard Deviation|Mean
830954|NCT01241240|Secondary|Change From Baseline in Mean Worse Eye IOP|IOP is a measurement of the fluid pressure inside the eye. For each eye, the IOP was either the average of 2 measurements, or, if a third measurement was required, the median of the 3 measurements. The worse eye was determined based on the IOP results at Baseline. The mean worse eye IOP was the average of the IOP measurements of the worse eye at hours 0 and 2 at each visit. A negative change from Baseline indicated improvement.|Baseline, Weeks 1, 2, 4 and 8|Participants from the mITT population, that included all randomized participants who had at least 1 post-baseline IOP measurement, with data available for analysis at the given time-point.||mmHg||Standard Deviation|Mean
830955|NCT01241240|Primary|Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) at Week 12|IOP is a measurement of the fluid pressure inside the eye. For each eye, the IOP was either the average of 2 measurements, or, if a third measurement was required, the median of the 3 measurements. The worse eye was determined based on the IOP results at Baseline. The mean worse eye IOP was the average of the IOP measurements of the worse eye at hours 0 and 2 at week 12. A negative change from Baseline indicated improvement.|Baseline, Week 12|Participants from the modified Intent-to-treat (mITT) population, that included all randomized participants who had at least 1 post-baseline IOP measurement, with data available for analysis at the given time-point.||mmHg||Standard Deviation|Mean
830956|NCT01241279|Secondary|Visual Acuity|Number of correct letters on an early treatment diabetic retinopathy study (ETDRS) chart to measure distance visual acuity and the smallest readable print size on an Minnesota Low-Vision Reading (MNREAD) acuity chart for intermediate and near visual acuity (VA). Visual acuity measured in LogMAR.|All visits through visit 4 (day 160-180)|DUE TO THE SMALL SAMPLE SIZE, NO STATISTICAL OR CLINICALLY MEANINGFUL CONCLUSIONS RELATED TO THE STUDY ENDPOINTS CAN BE MADE.|||||
830957|NCT01241279|Primary|Amplitude of Accommodation|The measurement of optical change in the power of the eye when viewing from far to near. Accommodation decreases as age increases resulting in an inability to focus on near objects.|Visit 4 (postoperative day 120-180)|DUE TO THE SMALL SAMPLE SIZE, NO STATISTICAL OR CLINICALLY MEANINGFUL CONCLUSIONS RELATED TO THE STUDY ENDPOINTS CAN BE MADE.|||||
830958|NCT01241292|Secondary|Number of Participants Positive for Anti-Elotuzumab Anti-drug Antibodies - Treated Participants|The detection of anti-elotuzumab anti-drug antibodies (ADAs) in human serum was performed using a validated bridging electrochemiluminescence immunoassay (ECLA) on the Meso Scale Discovery (MSD) platform. Sample collection was performed prior to administration of elotuzumab at Day 1 of each cycle.|First dose (Day 1) to last dose plus 60 days, up to 3 years|All participants who received at least one dose of study medication were summarized.||participants|||Number
830959|NCT01241292|Primary|Number of Participants With Worst Toxicity Grade Chemistry Laboratory Tests|NCI CTCAE, version 3.0 was used to measure toxicity scale. Sodium high (H) Gr 1:>ULN - 150; Gr 2: >150 – 155; Gr 3: >155 – 160; Gr 4: >160 mmol/L; Sodium low(L) Gr 1:<LLN – 130; Gr 3: <130 – 120; Gr 4: <120 mmol/L. Potassium (H) Gr 1: >ULN – 5.5; Gr 2: >5.5 – 6.0; Gr 3: > 6.0 – 7.0; Gr 4: >7.0 mmol/L; Potassium (L) Gr 1 - Gr 2: <LLN – 3.0; Gr 3: < 3.0 – 2.5; Gr 4: <2.5 mmol/L.|First dose (Day 1) to last dose plus 60 days, up to 3 years|All participants who received at least one dose of study medication were summarized.||participants|||Number
830960|NCT01241292|Primary|Number of Participants With Worst Toxicity Grade Renal and Liver Function Laboratory Tests|National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 was used to measure toxicity scale. Lower Limits of Normal (LLN). Upper Limits of Normal (ULN). Alanine transaminase (ALT); Aspartate aminotransferase (AST); Alkaline phosphatase (ALP). ALT Grade (Gr)1:>1.0 to 2.5*ULN; Gr 2: >2.5 to 5.0*ULN; Gr 3: >5.0 to 20.0*ULN; Gr 4: >20.0*ULN. AST Gr 1: >1.0 to 2.5*ULN; Gr 2: >2.5 to 5.0*ULN; Gr 3: >5.0 to 20.0*ULN; Gr 4: >20.0*ULN. Total bilirubin Gr 1: >1.0 to 1.5*ULN; Gr 2: >1.5 to 3.0*ULN; Gr 3: >3.0 to 10..0*ULN; Gr 4: >10.0.0*ULN. ALP (U/L) Gr1:>1.0 to 2.5*ULN, Gr2:>2.5 to 5.0*ULN, Gr3:>5.0 to 20.0*ULN, Gr4:>20.0*ULN. Albumin (low) Gr 1:<LLN to 3 grams per deciliter (g/dL); Gr 2: <3.0 – 2.0 g/L; Gr 3: < 2 g/dL. Creatinine Gr 1: >1 – 1.5*baseline (BL)to >ULN – 1.5*ULN; Gr 2: >1.5 – 3.0*BL to > 1.5 – 3.0*ULN; Gr 3: >3.0*BL to > 3.0 – 6.0*ULN; Gr 4: >6.0*ULN.|First dose (Day 1) to last dose plus 60 days, up to 3 years|All participants who received at least one dose of study medication were summarized.||participants|||Number
830961|NCT01241292|Primary|Number of Participants With Worst Toxicity Grade Hematology Laboratory Tests|National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 was used to measure toxicity scale. Lower Limits of Normal (LLN). Hemoglobin Gr 1:<LLN to 10.0 g/dL, Gr 2:<10.0 to 8.0 g/dL, Gr 3:<8.0 to 6.5 g/dL, Gr 4:<6.5 g/dL. Lymphocytes (absolute) Gr 1: <1.5 to 0.8 *10^3 c/µL, Gr 2 <0.8 to 0.5 *10^3 c/µL, Gr 3: <0.5 to 0.2 *10^3 c/µL, Gr 4: <0.2*10^3 c/µL. Neutrophils (absolute): Gr 1:<LLN to 1.5*10^9/L, Gr 2:<1.5 to 1.0*10^9/L, Gr 3:<1.0 to 0.5*10^9/L, Gr 4:<0.5*10^9/L. Platelet count Gr 1:LLN to 75.0*10^9/L, Gr 2:<75.0 to 50.0*10^9/L, Gr 3:<50.0 to 25.0*10^9/L, Gr 4:<25.0 to 10^9/L. Leukocytes Gr 1:<LLN to 3.0 *10^3 c/µL, Gr 2; <3.0 to 2.0 *10^3 c/µL, Gr 3: <2.0 to 1.0 *10^3 c/µL, Gr 4: <1.0 *10^3 c/µL.|First dose (Day 1) to last dose plus 60 days, up to 3 years|All participants who received at least one dose of study medication were summarized.||participants|||Number
830962|NCT01241292|Secondary|Geometric Mean Minimum Observed Serum Elotuzumab Concentration (Cmin) During Cycles 1, 2, and 3|The quantification of elotuzumab in human serum was performed using a validated enzyme-linked immunosorbent assay (ELISA). Cmin was measured in micrograms per milliliter (µg/mL). Samples of serum were obtained at: Cycle 1, Day 1: 0 hour (h), 30 minutes (min) 2 h post dose; Day 8: 0h, 2 h; Day 15: 0h, 30 min; Day 22: 0h, 30min, 2h. Cycle 2, Day 1, 22 0h, 2h. Cycle 3, Day 1: 0h, 30h, 2h; Day 15: 0h.|Days 8, 15 and 22 of cycle 1, Days 1 and 22 of cycle 2, Days 1 and 15 of cycle 3|All participants who received at least one dose of study medication and had adequate PK concentration profiles were summarized.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
830963|NCT01241292|Secondary|Geometric Mean Maximum Observed Serum Elotuzumab Concentration (Cmax) During Cycles 1, 2, and 3|The quantification of elotuzumab in human serum was performed using a validated enzyme-linked immunosorbent assay (ELISA). Cmax was measured in micrograms per milliliter (µg/mL). Samples of serum were obtained at: Cycle 1, Day 1: 0 hour (h), 30 minutes (min) 2 h post dose; Day 8: 0h, 2 h; Day 15: 0h, 30 min; Day 22: 0h, 30min, 2h. Cycle 2, Day 1, 22 0h, 2h. Cycle 3, Day 1: 0h, 30h, 2h; Day 15: 0h.|Days 1, 8, 15 and 22 of cycle 1, Days 1 and 22 of cycle 2, Days 1 and 15 of cycle 3|All participants who received at least one dose of study medication and had adequate Pharmacokinetic (PK) concentration profiles were summarized.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
830964|NCT01241292|Secondary|Number of Participants With Best Overall Response - Treated Participants|Complete response (CR) and Partial Response (PR) were based on the European Group for Blood and Bone Marrow Transplant (EBMT) Criteria. Very Good Partial response was derived from the International Myeloma Working Group (IMWG) criteria. Participants who had a reduction in M-protein or plasmacytoma but did not meet the EBMT criteria for PR were classified as minimal response (MR). Hematologic, radiologic and/or clinical assessments were done every cycle starting with cycle 2. Each cycle is 4 weeks in length (Day 1, Day 8, Day 15, Day 22). Cycle 2 began on study Day 29. CR=negative immunofixation 6 weeks, <5% plasma cells, no increase in size or number of lytic lesions, complete disappearance of extramedullary plasmacytoma. PR=≥50%reduction in M-protein for 6 weeks, ≥90% reduction of urinary light chain excretion or < 200 mg/24hours for 6 weeks, ≥50% reduction in size of extramedullary plasmacytoma present at baseline, no increase in size or number of lytic lesions.|Cycle 2 (Study Day 29) to last dose, up to 3 years|All participants who received at least one dose of study medication were summarized (Treated Participants).||participants|||Number
830965|NCT01241292|Primary|Number of Participants With Clinically Relevant Vital Sign Findings|Vital signs (body temperature, seated blood pressure, heart rate, and respiration rate) were recorded at screening on Days 1, 8, 15, and 22 of Cycles 1 and 2, on Days 1 and 15 of Cycle 3, and at the end of treatment. Blood pressure (Diastolic and Systolic) and heart rate were recorded after the participant sat quietly for at least 5 minutes. Clinical relevance of vital sign data was determined by the investigator.|First dose (Day 1) to last dose plus 60 days, up to 3 years|All participants who received at least one dose of study medication were summarized.||participants|||Number
831016|NCT01241591|Secondary|Mean SF-36 Domain Scores at Baseline and Week 12|The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Higher scores indicate a better health related quality of life.|Baseline and Week 12|FAS; OC||score on a scale||Standard Error|Mean
830966|NCT01241292|Primary|Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, Deaths|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. Data cut-off February 2014.|First dose (Day 1) to last dose plus 60 days, up to 3 years|All participants who received at least one dose of study medication were summarized (Treated Participants).||participants|||Number
830967|NCT01241513|Primary|Arterial Oxygen Saturation|Finger Pulse Oximetry to measure arterial oxygen saturation|Day 4 of treatment during acute altitude exposure|||percentage of oxygen saturation||Standard Deviation|Mean
830968|NCT01241539|Secondary|Additional Safety Parameters|By study design abnormalities could be due to dialysis or Dabigatran.|2 periods of 5 days each|TS||Participants|||Number
830969|NCT01241539|Secondary|Safety and Tolerability|Tolerability refers to the number of non-tolerable patients as assessed through the subjective examination of adverse events (AE). Safety refers to the number of patients with treatment emergent AEs. These numbers are presented on the overall Dabigatran treatment.|2 periods of 5 days each|TS||Participants|||Number
830970|NCT01241539|Secondary|Coagulation Parameters|Assessment of blood coagulation parameters 'activated partial thromboplastin time' (aPTT) and 'factor IIa inhibition' (anti-FIIa) measured with the diluted thrombin time assay. Time to the formation of a fibrin clot (coagulation) is measured in seconds.|Day 3|TS||sec||Standard Deviation|Mean
830971|NCT01241539|Secondary|Time to Maximum Plasma Concentration (Tmax)|Time to maximum plasma concentration of total and free dabigatran in plasma after the third administration of dabigatran.|Day 3|PKS||h||Geometric Coefficient of Variation|Geometric Mean
830972|NCT01241539|Secondary|Maximum Plasma Concentrations of Dabigatran (Cmax)|Maximum measured concentration of total and free dabigatran in plasma after the second and third administration of dabigatran.|Days 2 and 3|PKS||ng/mL||Geometric Coefficient of Variation|Geometric Mean
830973|NCT01241539|Secondary|Area Under the Curve Exposure to Dabigatran During the First 8 Hours Post Dose (AUC0-8h)|Area under the concentration-time curve of total and free dabigatran in plasma over the time interval from 0 to 8 hours after the second and third administration of dabigatran.|Days 2 and 3|Pharmacokinetic set (PKS) includes all evaluable patients of the TS who received at least 1 dose of dabigatran etexilate, who provided at least 1 observation for at least 1 Pharmacokinetics (PK) endpoint, and who did not have important protocol violations relevant to the evaluation of PK||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
830974|NCT01241539|Primary|Plasma Concentration Extraction Ratio|Plasma concentration extraction ratio was measured directly at the dialysis machine and computed as the difference of the predialysis plasma concentration and the postdialysis plasma concentration relative to the predialysis concentration on the percentage scale (minimum: 0 percent of extraction (worst), maximum: 100 percent of extraction).|4 hours|PKS||Percentage||Geometric Coefficient of Variation|Geometric Mean
830975|NCT01241539|Primary|Extent Cleared From Circulation (Plasma) During 1 Complete Cycle of Dialysis|Extent of dabigatran that is removed from blood during one complete 4-hour cycle of dialysis was computed by the difference of plasma concentration at the start and at the end of dialysis relative to the start concentration and is therefore measured as a percentage.|4 hours|PKS||Percentage||Geometric Coefficient of Variation|Geometric Mean
830976|NCT01241539|Primary|Dialysis Clearance of Dabigatran|Dialysis clearance of dabigatran from blood (CLD,b) and dialysis clearance of dabigatran from plasma (CLD) were calculated and indicate how quickly dabigatran is cleared out from blood or plasma.|4 hours|Pharmacokinetic set (PKS) includes all evaluable patients of the treated set who received at least one dose of dabigatran etexilate and who provide at least one observation for at least one Pharmacokinetic (PK) endpoint without important protocol violations relevant to the evaluation of PK.||mL/min||Geometric Coefficient of Variation|Geometric Mean
830977|NCT01241552|Secondary|Percentage of Participants With Compromised Immunity at Study Entry With CDI Recurrence|CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive local or central lab stool test for toxigenic C. difficile following clinical cure of the initial CDI episode. Compromised immunity is defined as follows: an active hematological malignancy (including leukemia, lymphoma, multiple myeloma), an active malignancy requiring recent cytotoxic chemotherapy, receipt of a prior hematopoietic stem cell transplant, receipt of a prior solid organ transplant, asplenia, or neutropenia/pancytopenia due to other conditions.|Up to 12 weeks|Participants with compromised immunity at study entry who received infusion of study medication; had a positive local stool test for toxigenic C. difficile; received protocol defined standard of care therapy within 1 day window of the infusion; and complied with Good Clinical Practice.||Percentage of participants|||Number
830978|NCT01241552|Secondary|Percentage of Participants With an Epidemic Strain of C. Difficile (Ribotypes 027, 014, 002, 001, 106, and 020) at Study Entry With CDI Recurrence|CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive local or central lab stool test for toxigenic C. difficile following clinical cure of the initial CDI episode.|Up to 12 weeks|Participants with an epidemic strain of C. difficile at study entry who received infusion of study medication; had a positive local stool test for toxigenic C. difficile; received protocol defined standard of care therapy within 1 day window of the infusion; and complied with Good Clinical Practice.||Percentage of participants|||Number
830979|NCT01241552|Secondary|Percentage of Participants With the B1/NAP1/027 Strain of C. Difficile at Study Entry With CDI Recurrence|CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive local or central lab stool test for toxigenic C. difficile following clinical cure of the initial CDI episode.|Up to 12 weeks|Participants with the B1/NAP1/027 strain of C. difficile at study entry who received infusion of study medication; had a positive local stool test for toxigenic C. difficile; received protocol defined standard of care therapy within 1 day window of the infusion; and complied with Good Clinical Practice.||Percentage of participants|||Number
831029|NCT01241591|Secondary|Median Time to Achieve PASI75 Response During the 12-Week Double-Blind Treatment||Baseline up to Week 12|FAS; OC||weeks||95% Confidence Interval|Median
830980|NCT01241552|Secondary|Percentage of Participants With Clinically Severe CDI at Study Entry With CDI Recurrence|CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive local or central lab stool test for toxigenic C. difficile following clinical cure of the initial CDI episode. Clinically severe CDI is defined as a Zar Score ≥ 2 based on the presence of 1 or more of the following: 1) age >60 years old (1 point); 2)body temperature >38.3°C (>100°F) (1 point); 3) albumin level ˂2.5 mg/dL (1 point); 4) peripheral white blood cell count >15,000 cells/mm^3 within 48 hours (1 point); 5) endoscopic evidence of pseudomembranous colitis (2 points); and 6) treatment in Intensive Care Unit (2 points).|Up to 12 weeks|Participants with clinically severe CDI at study entry who received infusion of study medication; had a positive local stool test for toxigenic C. difficile; received protocol defined standard of care therapy within 1 day window of the infusion; and complied with Good Clinical Practice.||Percentage of participants|||Number
830981|NCT01241552|Secondary|Percentage of Participants With a History of CDI in the 6 Months Prior to Enrollment With CDI Recurrence|CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive local or central lab stool test for toxigenic C. difficile following clinical cure of the initial CDI episode.|Up to 12 weeks|Participants with a history of CDI in the 6 months prior to enrollment who received infusion of study medication; had a positive local stool test for toxigenic C. difficile; received protocol defined standard of care therapy within 1 day window of the infusion; and complied with Good Clinical Practice.||Percentage of participants|||Number
830982|NCT01241552|Secondary|Percentage of Participants ≥ 65 Years of Age at Study Entry With CDI Recurrence|CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive local or central lab stool test for toxigenic C. difficile following clinical cure of the initial CDI episode.|Up to 12 weeks|Participants ≥ 65 years of age at study entry who received infusion of study medication; had a positive local stool test for toxigenic C. difficile; received protocol defined standard of care therapy within 1 day window of the infusion; and complied with Good Clinical Practice.||Percentage of participants|||Number
830983|NCT01241552|Primary|Percentage of Participants With Infusion-specific AEs|Infusion-specific AEs included local infusion site AEs; and systemic AEs which include nausea, vomiting, chills, fatigue, feeling hot, infusion site conditions (bruising, coldness, erythema, extravasation, pain, phlebitis, pruritus), pyrexia, arthralgia, musculoskeletal pain, myalgia, dizziness, headache, dysphonia, nasal congestion, pruritus, rash, pruritic rash, urticaria, flushing, hot flush, hypertension, and hypotension.|Up to 24 hours|All randomized participants who received infusion of study medication, based on the treatment actually received. One participant randomized to receive MK-3415A, and two participants randomized to receive MK-6072 actually received placebo instead.||Percentage of participants|||Number
830984|NCT01241552|Primary|Percentage of Participants Who Discontinued Study Medication Due to an AE During 4 Weeks Following Infusion|An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended signs (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specific procedure, whether or not considered related to the medicinal product or protocol-specific procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an AE.|Up to 28 days|All randomized participants who received infusion of study medication, based on the treatment actually received. One participant randomized to receive MK-3415A, and two participants randomized to receive MK-6072 actually received placebo instead.||Percentage of participants|||Number
830985|NCT01241552|Primary|Percentage of Participants With Any Serious Drug-related Adverse Events During 4 Weeks Following Infusion|A SAE is any AE occurring at any dose or during any use of Sponsor’s product that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer, or is associated with an overdose (whether accidental or intentional); or is other important medical events. A serious drug-related AE was a SAE determined by the investigator to be related to the drug.|Up to 28 days|All randomized participants who received infusion of study medication, based on the treatment actually received. One participant randomized to receive MK-3415A, and two participants randomized to receive MK-6072 actually received placebo instead.||Percentage of participants|||Number
830986|NCT01241552|Primary|Percentage of Participants With Any Serious Adverse Events (SAEs) During 4 Weeks Following Infusion|A SAE is any AE occurring at any dose or during any use of Sponsor’s product that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer, or is associated with an overdose (whether accidental or intentional); or is other important medical events.|Up to 28 days|All randomized participants who received infusion of study medication, based on the treatment actually received. One participant randomized to receive MK-3415A, and two participants randomized to receive MK-6072 actually received placebo instead.||Percentage of participants|||Number
830987|NCT01241552|Primary|Percentage of Participants With Any Drug-related AE During 4 Weeks Following Infusion|An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended signs (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specific procedure, whether or not considered related to the medicinal product or protocol specific procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an AE. A drug-related AE was an AE determined by the investigator to be related to the drug.|Up to 28 days|All randomized participants who received infusion of study medication, based on the treatment actually received. One participant randomized to receive MK-3415A, and two participants randomized to receive MK-6072 actually received placebo instead.||Percentage of participants|||Number
831615|NCT01247428|Secondary|Lesion Success|Achievement of a final in-stent residual diameter stenosis of <50% (by QCA) using any percutaneous method|8 hours|||percentage of participants||95% Confidence Interval|Number
830988|NCT01241552|Primary|Percentage of Participants With One or More Adverse Events (AEs) During 4 Weeks Following Infusion|An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended signs (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specific procedure, whether or not considered related to the medicinal product or protocol specific procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an AE.|Up to 28 days|All randomized participants who received infusion of study medication, based on the treatment actually received. One participant randomized to receive MK-3415A, and two participants randomized to receive MK-6072 actually received placebo instead.||Percentage of participants|||Number
830989|NCT01241552|Secondary|Percentage of Participants With CDI Recurrence in Those With Clinical Cure of the Initial CDI Episode|CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive local or central lab stool test for toxigenic C. difficile following clinical cure of the initial CDI episode. Clinical cure is defined as participants who received ≤ 14 day regimen of SOC therapy and have no diarrhea (≤2 loose stools per 24 hours) for two consecutive days following completion of SOC therapy for the baseline CDI episode.|Up to 12 weeks|Participants who received infusion of study medication; had a positive local stool test for toxigenic C. difficile; received protocol defined standard of care therapy within 1 day window of the infusion; complied with Good Clinical Practice; and achieved clinical cure of the initial CDI episode.||Percentage of participants|||Number
830990|NCT01241552|Secondary|Percentage of Participants With Global Cure|Global Cure is defined as the clinical cure of the initial CDI episode and no CDI recurrence through Week 12. Clinical cure is defined as participants who received ≤ 14 day regimen of SOC therapy and have no diarrhea (≤2 loose stools per 24 hours) for two consecutive days following completion of SOC therapy for the initial CDI episode.|Up to 12 weeks|Participants who received infusion of study medication; had a positive local stool test for toxigenic C. difficile; received protocol defined standard of care therapy within 1 day window of the infusion; and complied with Good Clinical Practice.||Percentage of participants|||Number
830991|NCT01241552|Primary|Percentage of Participants With Clostridium Difficile Infection (CDI) Recurrence|CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive local or central lab stool test for toxigenic Clostridium (C.) difficile following clinical cure of the initial CDI episode|Up to 12 weeks|Participants who received infusion of study medication; had a positive local stool test for toxigenic C. difficile; received protocol defined standard of care therapy within 1 day window of the infusion; and complied with Good Clinical Practice.||Percentage of participants|||Number
830992|NCT01241565|Secondary|Incidence of Serosal Tearing||Day 30|||participants||95% Confidence Interval|Number
830993|NCT01241565|Secondary|Duration of Chest Tube Following Surgery|Chest tube duration was calculated as removal date – placement date + 1|Approximately Day 5|||days||Standard Deviation|Mean
830994|NCT01241565|Secondary|Length of Hospital Stay||Approximately Day 6|||days||Standard Deviation|Mean
830995|NCT01241565|Secondary|Duration of Air Leak|Measured in days. For patients discharged from the hospital with a Heimlich valve, the duration will be censored on the date of discharge.|Day 30|||days||Standard Deviation|Mean
830996|NCT01241565|Secondary|Incidence of Air Leaks|As recorded on the air leak log.|Day 30|||number of patients with air leaks|||Number
830997|NCT01241565|Primary|Incidence of Prolonged Air Leaks|Defined as > 5 days by the Society for Thoracic Surgery|Day 30|||participants|||Number
830998|NCT01241591|Secondary|Mean Change From Baseline in PQOL-12 Score During the 12-Week Double-Blind Treatment|The PQOL-12 is a 12-item questionnaire; 8 of the items on the PQOL-12) focus on emotional issues associated with psoriasis (self conscious, helpless, embarrassed, ability to enjoy life). The last 4 items deal with physical symptoms (pain or soreness, itch, physical irritation) and choice of clothing. The recall period is over the past month. The questions are answered on a scale from 0 to 10 with 0 being best and 10 being worst. Scores from each question are summed to give a total score (range 0 -120); higher scores indicate greater impairment to quality of life.|Week 12|FAS; OC||scores on a scale||Standard Error|Mean
830999|NCT01241591|Secondary|Mean Psoriasis Quality of Life 12 (PQOL-12) Score During the 12-Week Double-Blind Treatment|The PQOL-12 is a 12-item questionnaire; 8 of the items on the Koo-Menter Psoriasis Index 12-item Quality of Life Questionnaire (PQOL-12) focus on emotional issues associated with psoriasis (self conscious, helpless, embarrassed, ability to enjoy life). The last 4 items deal with physical symptoms (pain or soreness, itch, physical irritation) and choice of clothing. The recall period is over the past month. The questions are answered on a scale from 0 to 10 with 0 being best and 10 being worst. Scores from each question are summed to give a total score (range 0 -120); higher scores indicate greater impairment to quality of life.|Baseline and Week 12|FAS; OC||score on a scale||Standard Error|Mean
831000|NCT01241591|Secondary|Percentage of Participants Reporting Work-Impacted Events During the 12-Week Double-Blind Treatment|Psoriasis Health Care Resource Utilization Questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work.|Week 12|FAS; OC||percentage of participants|||Number
831001|NCT01241591|Secondary|Percentage of Participants Employed or Not Employed and the Impact of Psoriasis on Work|Psoriasis Health Care Resource Utilization Questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The questionnaire assesses employment status of participant (employed: yes or no) and if currently employed it asks the participant if they were absent or on sick leave from work due to psoriasis; if unemployed it asks the participant if the unemployment is due to psoriasis.|Baseline and Week 12|FAS; OC||percentage of participants|||Number
831002|NCT01241591|Secondary|Percentage of Participants Reporting Healthcare Resource Use Events During the 12-Week Double-Blind Treatment||Week 12|FAS; OC||percentage of participants|||Number
831244|NCT01244893|Primary|Visual Acuity (VA)|Snellen VA was measured to the nearest letter then converted to the logMAR scale for the analysis. Values < 0 imply a clinically positive result; while values > 0 infer a clinically negative result.|6-8 days after lens wear|Population analyzed are those who were enrolled, randomized, and completed the study.||logMAR scale||Standard Deviation|Mean
831003|NCT01241591|Secondary|Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment|The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use (interactions with healthcare providers such as general practitioners [GPs], primary care physicians [PCPs], or family medicine physicians [FMP], emergency room visits, and hospitalizations), and the second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work.|Baseline (BL) and Week 12|FAS; OC||percentage of participants|||Number
831004|NCT01241591|Secondary|Mean Change From Baseline in EQ-5D Dimension Health State Score at Week 12|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. The score for each of the 5 dimensions can range from 1 to 3; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed)."|Week 12|FAS; OC||scores on a scale||Standard Error|Mean
831005|NCT01241591|Secondary|Dimension Health State EQ-5D Score During the 12-Week Double-Blind Treatment|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. The score for each of the 5 dimensions can range from 1 to 3; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed)."|Baseline and Week 12|FAS; OC||Units on a scale||Standard Error|Mean
831006|NCT01241591|Secondary|Mean Change From Baseline in EQ-5D VAS at Week 12|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Week 12|FAS; OC||mm||Standard Error|Mean
831007|NCT01241591|Secondary|Mean EQ-5D Visual Analog Score (VAS) During the 12-Week Double-Blind Treatment|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline and Week 12|FAS; OC||mm||Standard Error|Mean
831008|NCT01241591|Secondary|Least Squares (LS) Mean Change From Baseline in EQ-5D Health State Utility Score During the 12-Week Double-Blind Treatment|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Week 12|FAS; OC||scores on a scale||Standard Error|Least Squares Mean
831009|NCT01241591|Secondary|Mean European Quality of Life 5 Dimension (EQ-5D) Health State Utility Score During the 12-Week Double-Blind Treatment|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Baseline and Week 12|FAS; OC||score on a scale||Standard Error|Mean
831010|NCT01241591|Secondary|Percentage of Participants Achieving PSSM Response of 'Very Satisfied' or 'Somewhat Satisfied' at Week 12|The PSSM is a single, 7 point item that evaluates overall participant satisfaction with the study treatment. Response options range from “very dissatisfied” to “very satisfied” with the study medication.|Week 12|FAS; OC||percentage of participants|||Number
831011|NCT01241591|Secondary|Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Category During the 12-Week Double-Blind Treatment|The PSSM is a single, 7 point item that evaluates overall participant satisfaction with the study treatment. Response options range from “very dissatisfied” to “very satisfied” with the study medication.|Week 12|FAS; OC||percentage of participants|||Number
831012|NCT01241591|Secondary|Percentage of Participants With a PtGA Response During the 12-Week Double-Blind Treatment|The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5-point scale (0=clear; 1=almost clear; 2=mild; 3=moderate; 4=severe). Response defined as score of 0 or 1.|Weeks 2, 4, 8, and 12|FAS; OC||percentage of participants|||Number
831013|NCT01241591|Secondary|Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment|The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5-point scale (0=clear; 1=almost clear; 2=mild; 3=moderate; 4=severe).|Baseline and Weeks 2, 4, and 8|FAS; OC||percentage of participants|||Number
831014|NCT01241591|Secondary|Mean Change From Baseline in SF-36 Domain Scores|The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Higher scores indicate a better health related quality of life.|Week 12|FAS; OC||score on a scale||Standard Error|Mean
831015|NCT01241591|Secondary|Mean Change From Baseline in SF-36 MCS and PCS Scores|The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). A PCS score and MCS score are based on a normalized sum of the 8 scale scores; PCS/MCS summary concept score = (raw score*10) plus 50. Higher scores indicate a better health related quality of life.|Week 12|FAS; OC||score on a scale||Standard Error|Mean
831017|NCT01241591|Secondary|Mean Short Form 36 (SF-36) Mental Component Summary (MCS) and Physical Component Summary (PCS) Scores at Baseline and Week 12|The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). A PCS score and MCS score are based on a normalized sum of the 8 scale scores; PCS/MCS summary concept score = (raw score*10) plus 50. Higher scores indicate a better health related quality of life.|Baseline and Week 12|FAS; OC||score on a scale||Standard Error|Mean
831018|NCT01241591|Secondary|Median Time to DLQI Response|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. DLQI Response was defined as a 5-point reduction in the total DLQI score.|Weeks 4 and 12|Data were not analyzed as the endpoint of proportion of participants achieving a 5-point reduction from baseline in DLQI provided similar information.|||||
831019|NCT01241591|Secondary|Percentage of Participants Achieving DLQI Response ≤1 During the 12-Week Double-Blind Treatment|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.|Weeks 4 and 12|FAS; OC||percentage of participants|||Number
831020|NCT01241591|Secondary|Percentage of Participants Achieving DLQI Response ≥5 During the 12-Week Double-Blind Treatment|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.|Weeks 4 and 12|FAS; OC||percentage of participants|||Number
831021|NCT01241591|Secondary|Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much); higher scores indicate poor quality of life. The DLQI can be analyzed under 6 subscales by combining questions and is categorized as follows: symptoms and feelings (maximum score=6); daily activities (maximum score=6); leisure (maximum score=6); work and school (maximum score=3); personal relationships (maximum score=6); and treatment (maximum score=3). The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.|Weeks 4 and 12|FAS; OC||scores on a scale||Standard Error|Mean
831022|NCT01241591|Secondary|Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much); higher scores indicate poor quality of life. The DLQI can be analyzed under 6 subscales by combining questions and is categorized as follows: symptoms and feelings (maximum score=6); daily activities (maximum score=6); leisure (maximum score=6); work and school (maximum score=3); personal relationships (maximum score=6); and treatment (maximum score=3).|Baseline and Weeks 4 and 12|FAS; OC||score on a scale||Standard Error|Mean
831023|NCT01241591|Secondary|Mean Change From Baseline in DLQI Score During the 12-Week Double-Blind Treatment|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.|Weeks 4 and 12|FAS; OC||score on a scale||Standard Error|Mean
831024|NCT01241591|Secondary|Mean Dermatology Life Quality Index (DLQI) Score During the 12-Week Double-Blind Treatment|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.|Baseline and Weeks 4 and 12|FAS; OC||score on a scale||Standard Error|Mean
831025|NCT01241591|Secondary|Percentage of Participants Achieving an ISI Score of 0 During the 12-Week Double-Blind Treatment|ISI assessed severity of itch (pruritus) due to psoriasis. ISI is a single item, horizontal numeric rating scale. Participants were asked to rate “your worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “No itching” (0) and “Worst possible itching” (10) at the ends.|Weeks 2, 4, 8, and 12|FAS; OC||percentage of participants|||Number
831026|NCT01241591|Secondary|Mean Change From Baseline in ISI Score During the 12-Week Double-Blind Treatment|ISI assessed severity of itch (pruritus) due to psoriasis. ISI is a single item, horizontal numeric rating scale. Participants were asked to rate “your worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “No itching” (0) and “Worst possible itching” (10) at the ends.|Weeks 2, 4, 8, and 12|FAS; OC||score on a scale||Standard Error|Mean
831027|NCT01241591|Secondary|Mean Itch Severity Item (ISI) Score During the 12-Week Double-Blind Treatment|ISI assessed severity of itch (pruritus) due to psoriasis. ISI is a single item, horizontal numeric rating scale. Participants were asked to rate “your worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “No itching” (0) and “Worst possible itching” (10) at the ends.|Baseline, Weeks 2, 4, 8, and 12|FAS; OC||score on a scale||Standard Error|Mean
831028|NCT01241591|Secondary|Percentage of Participants With a PASI Score Greater Than or Equal to (≥)125% of the Baseline PASI Score During the 12-Week Double-Blind Treatment||Weeks 2, 4, 8, and 12|FAS; OC||percentage of participants|||Number
831030|NCT01241591|Secondary|Percentage of Participants Who Achieved a 90% Reduction in PASI Relative to Baseline (PASI90) During the 12-Week Double-Blind Treatment|PASI quantifies severity of psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite score by the investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0; higher scores represent greater severity of psoriasis.|Weeks 2, 4, 8, and 12|FAS; OC||percentage of participants|||Number
831031|NCT01241591|Secondary|Median Time to PASI50 Response During the 12-Week Double-Blind Treatment||Baseline up to Week 12|FAS; OC||weeks||95% Confidence Interval|Median
831032|NCT01241591|Secondary|Percentage of Participants Who Achieved a 50% Reduction in PASI Relative to Baseline (PASI50) During the 12-Week Double-Blind Treatment|PASI quantifies severity of psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite score by the investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0; higher scores represent greater severity of psoriasis.|Weeks 2, 4, 8, and 12|FAS; OC||percentage of participatns|||Number
831033|NCT01241591|Secondary|Mean Percent Change From Baseline in Total Psoriatic BSA During the 12-Week Double-Blind Treatment|Assessment of BSA with psoriasis performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The %surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant(fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis.|Weeks 2, 4, 8, and 12|FAS; OC||percent change from baseline||Standard Error|Mean
831034|NCT01241591|Secondary|Mean Percentage of Total Psoriatic BSA During the 12-Week Double-Blind Treatment|Assessment of BSA with psoriasis performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The % surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis.|Baseline and Weeks 2, 4, 8, and 12|FAS; OC||percent psoriatic BSA||Standard Error|Mean
831035|NCT01241591|Secondary|Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis.|Weeks 2, 4, 8, and 12|FAS; OC||scores on a scale||Standard Error|Mean
831036|NCT01241591|Secondary|Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis.|Baseline and Weeks 2, 4, 8, and 12|FAS; OC||score on a scale||Standard Error|Mean
831037|NCT01241591|Secondary|Mean Change From Baseline in PASI Score During the 12-Week Double-Blind Treatment|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis.|Weeks 2, 4, 8, and 12|FAS; OC||scores on a scale||Standard Error|Mean
831038|NCT01241591|Secondary|Mean PASI Score During the 12-Week Double-Blind Treatment|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis.|Baseline and Weeks 2, 4, 8, and 12|FAS; OC||score on a scale||Standard Error|Mean
831039|NCT01241591|Secondary|Percentage of Participants With a PASI75 Response During the 12-Week Double-Blind Treatment|The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response was defined as at least a 75% reduction in PASI relative to baseline/Day 1.|Weeks 2, 4, and 8|FAS; OC||percentage of participants|||Number
831040|NCT01241591|Secondary|Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 to 4). The severity scores are summed and averaged after which the total average is rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe).|Baseline and Weeks 2, 4, 8, and 12|FAS; OC||percentage of participants|||Number
831041|NCT01241591|Secondary|"Percentage of Participants With a PGA Response of Clear or Almost Clear During the 12-Week Double-Blind Treatment"|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 to 4). The severity scores are summed and averaged after which the total average is rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response is defined as 0 (clear) or 1 (almost clear).|Weeks 2, 4, and 8|FAS; Observed Case (OC): no imputation||percentage of participants|||Number
831042|NCT01241591|Primary|Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12|The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and the percent of body surface area (BSA) affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response was defined as at least a 75 percent (%) reduction in PASI relative to baseline/Day 1.|Week 12|FAS; NRI||percentage of participants|||Number
831043|NCT01241591|Primary|"Percentage of Participants With a Physician's Global Assessment (PGA) Response of Clear or Almost Clear at Week 12"|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 to 4). The severity scores are summed and averaged after which the total average is rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).|Week 12|Full Analysis Set (FAS): all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550, etanercept, or placebo); Non-Responder Imputation (NRI) method: participants with missing values were considered to be non-responders.||percentage of participants|||Number
831044|NCT01241760|Secondary|Percentage of Participants of Each IL28B Genotype Achieving Sustained Virologic Response 12 Weeks After the Last Planned Dose of Study Medication (SVR12 Planned)|The table below shows the effect of interleukin 28B (IL28B) gene's subtype (CC, CT or TT genotype) on the primary outcome measure: SVR12 planned.|End of trial, 12 weeks after the last planned dose|All analyses were performed on the full analysis (FA) set, which was defined as all randomized subjects who received at least one dose of study drug.||percentage of participants with response|||Number
831045|NCT01241760|Secondary|Percentage of Participants Who Relapsed During Follow-up Period|The table below shows the percentage of participants who relapsed (ie, those having confirmed detectable hepatitis C virus [HCV] ribonucleic acid [RNA] during the 12-week follow-up period after previous HCV RNA <25 IU/mL, target not detected, at end of treatment).|During Follow-Up (24 weeks after the last dose of study drug)|The analysis was performed on subjects with HCV RNA <25 IU/mL at the planned end of treatment, which included all randomized participants who received at least one dose of study drug and had data at the follow-up visit performed 24 weeks after the last dose of study drug.||percentage of participants|||Number
831046|NCT01241760|Secondary|Percentage of Participants With On-treatment Virologic Failure Which Required Them to Permanently Discontinue All Study Drugs|The table below shows the percentage of participants who met a stopping rule, defined as having a hepatitis C virus (HCV) ribonucleic acid (RNA) value at Week 4 >1000 IU/mL and at Weeks 12, 24, 32 and 40 ≥25 IU/mL.|Week 4, 12, 24, 32, 40|All analyses were performed on the full analysis (FA) set, which was defined as all randomized subjects who received at least one dose of study drug.||percentage of participants|||Number
831047|NCT01241760|Secondary|Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected, at Different Time Points.|The table below shows the percentage of participants with undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) levels, which means less than 25 IU/ml, target not detected, at different time points during the study.|Baseline, Week 4 and Week 4+12.|All analyses were performed on the full analysis (FA) set, which was defined as all randomized subjects who received at least one dose of study drug.||percentage of participants with response|||Number
831048|NCT01241760|Secondary|Percentage of Participants With Sustained Virologic Response 72 Weeks After the Start of Study Medication (SVR72 Planned)|The table below shows the percentage of participants achieving SVR 72 weeks after the start of study medication (SVR72 planned). SVR was defined as having plasma Hepatitis C Virus (HCV) ribonucleic acid (RNA) levels less than 25 IU/mL, target not detected, at end of treatment and up to 72 weeks after start of study medication (i.e., no confirmed detectable HCV RNA in between).|End of trial, 72 weeks after the start of study medication|All analyses were performed on the full analysis (FA) set, which was defined as all randomized subjects who received at least one dose of study drug.||percentage of participants with response|||Number
831049|NCT01241760|Secondary|Percentage of Participants With Sustained Virologic Response 24 Weeks After the Last Planned Dose of Study Drugs (SVR24 Planned)|The table below shows the percentage of participants achieving SVR 24 weeks after the last planned dose of study medication. SVR was defined as having Hepatitis C Virus (HCV) ribonucleic acid (RNA) levels less than 25 international units/milliliter (IU/mL). The response for T12(b.i.d)/PR group is higher than that after 12 weeks because HCV RNA data for two participants were missing for SVR assessment at that time. Consequently, by definition of SVR12, they were counted as not having achieved SVR12.|End of trial, 24 weeks after last planned dose|All analyses were performed on the full analysis (FA) set, which was defined as all randomized subjects who received at least one dose of study drug.||percentage of participants with response|||Number
831050|NCT01241760|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After the Last Planned Dose of Study Drugs (SVR12 Planned)|The table below shows the percentage of participants achieving Sustained Virologic Response 12 weeks after last planned dose of study medication (SVR12 planned). SVR was defined as having Hepatitis C Virus (HCV) ribonucleic acid (RNA) levels less than 25 international units/milliliter (IU/mL).|End of trial, 12 weeks after last planned dose|All analyses were performed on the full analysis (FA) set, which was defined as all randomized subjects who received at least one dose of study drug.||percentage of participants with response|||Number
831051|NCT01241903|Secondary|Biomarkers of Platelet Function and Myocardial Necrosis||up to 30 days||||||
831052|NCT01241903|Primary|Platelet - Leukocyte Aggregates|measured by flow cytometry|within first 24 hours|||% leukocytes with platelets attached||Standard Error|Mean
831053|NCT01241916|Secondary|Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire|The DASH questionnaire measures arm-specific perceived disability. It contains 30 items and is scaled between zero and 100 with higher scores indicating worse upper-extremity function.|12 months|||units on a scale||Full Range|Mean
831054|NCT01241916|Primary|Change in Arc of Flexion and Extension|Active ulnohumeral motion will be measured using a hand-held goniometer by the co-investigator not involved in the care of the patient at enrollment and 6 months after enrollment.|baseline and 6 months|||Degrees||Full Range|Mean
831055|NCT01242020|Secondary|Microvascular Flow in the Periadventitial, Subcutaneous and Skeletal Muscle Tissues||up to 30 days|Reliable data for periadventitial microvascular flow, subcutaneous microvascular flow, and skeletal muscle microvascular flow were not be collected for this outcome measure.|||||
831056|NCT01242020|Primary|Variability of Repeated Measures for Each Subject|The variability of repeated measures for each subject, expressed as coefficient of variation (CV), in the periadventitial microvascular flow, subcutaneous microvascular flow and skeletal muscle flow.|up to 30 days|Reliable data for periadventitial microvascular flow, subcutaneous microvascular flow, and skeletal microvascular flow were not collected for the Outcome Measure.|||||
831057|NCT01236053|Primary|Number of Renal Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin|Incident renal cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile’s with 2 year lag: Tertile 1 (0.1 - 30.0 grams), Tertile 2 (30.1 - 189.0 grams), and Tertile 3 (189.1 - 9600.0 grams). Tertile’s without 2 year lag: Tertile 1 (0.1 - 30.0 grams), Tertile 2 (30.1 - 189.0 grams), and Tertile 3 (189.1 - 11610.0 grams).|The case index date was the date of incident renal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
831058|NCT01236053|Primary|Number of Renal Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin|Incident renal cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date.|The case index date was the date of incident renal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
831059|NCT01236053|Primary|Number of Renal Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin|Incident renal cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile’s with 2 year lag: Tertile 1 (0.01 - 1.38 months), Tertile 2 (1.39 - 5.56 months), and Tertile 3 (5.57 - 105.82 months). Tertile’s without 2 year lag: Tertile 1 (0.01 - 1.38 months), Tertile 2 (1.39 - 5.72 months), and Tertile 3 (5.73 - 123.70 months).|The case index date was the date of incident renal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
831060|NCT01236053|Primary|Number of Renal Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions|Incident renal cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile’s with 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-7 prescriptions), Tertile 3 (8-298 prescriptions). Tertiles without 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-7 prescriptions), and Tertile 3 (8-388 prescriptions).|The case index date was the date of incident renal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
831245|NCT01244906|Secondary|Number of Patients With Overall Survival at 2 Years.||2 years|||participants|||Number
831246|NCT01244906|Secondary|Number of Patients to Achieve Full Donor Chimerism|Characterize rate of achievement of full donor chimerism|1 year|||participants|||Number
831061|NCT01236053|Primary|Number of Renal Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin|Incident renal cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin prescription from cohort entry to index date.|The case index date was the date of incident pancreatic cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
831062|NCT01236053|Primary|Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin|Incident pancreatic cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile’s with 2 year lag: Tertile 1 (0.1 - 30.0 grams), Tertile 2 (30.1 - 189.0 grams), and Tertile 3 (189.1 - 9600.0 grams). Tertile’s without 2 year lag: Tertile 1 (0.1 - 30.0 grams), Tertile 2 (30.1 - 189.0 grams), and Tertile 3 (189.1 - 11610.0 grams).|The case index date was the date of incident pancreatic cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
831063|NCT01236053|Primary|Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin|Incident pancreatic cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date.|The case index date was the date of incident pancreatic cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as for the case|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
831064|NCT01236053|Primary|Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin|Incident pancreatic cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile’s with 2 year lag: Tertile 1 (0.01 - 1.38 months), Tertile 2 (1.39 - 5.56 months), and Tertile 3 (5.57 - 105.82 months). Tertile’s without 2 year lag: Tertile 1 (0.01 - 1.38 months), Tertile 2 (1.39 - 5.72 months), and Tertile 3 (5.73 - 123.70 months).|The case index date was the date of incident pancreatic cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
831065|NCT01236053|Primary|Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions|Incident pancreatic cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile’s with 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-7 prescriptions), Tertile 3 (8-298 prescriptions). Tertiles without 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-7 prescriptions), and Tertile 3 (8-388 prescriptions).|The case index date was the date of incident pancreatic cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
831066|NCT01236053|Primary|Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin|Incident pancreatic cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin prescription from cohort entry to index date.|The case index date was the date of incident pancreatic cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
831157|NCT01244126|Primary|Maximum Postoperative Face, Legs, Activity, Cry and Consolability (FLACC) Pain Score.|FLACC assigns 0-2 points for each of 5 categories (face, legs, activity, cry, consolability)and sums these points to give a total score where high scores indicate worse pain (Paediatr Anaesth 2006; 16: 258-65)|Upon arrival in the PACU, and at 5, 10, 15, 30, 45, 60 minutes and at discharge|Analysis was performed on per protocol basis excluding patients with protocol violations||units on a scale||Standard Deviation|Mean
831247|NCT01244906|Secondary|Number of Patients With Disease Free Survival at 2 Years||2 years|||participants|||Number
831067|NCT01236053|Primary|Number of Other Nervous System (ONS) Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin|Incident ONS cancer. Gabapentin (Gaba.) Exposure Description: With 2 year (yr) lag=Gaba. exposure from cohort entry to 2 yr prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (0.1-30.0 grams [g]), T 2 (30.1-189.0 g), and T 3 (189.1-9600.0 g). Tertiles without 2 yr lag: T 1 (0.1-30.0 g), T 2 (30.1-189.0 g), and T 3 (189.1-11610.0 g). Inestimable OR and 95% CI when no gaba.-exposed cancer cases or controls at the exposure level.|The case index date was the date of incident other nervous system cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was same as for case|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
831068|NCT01236053|Primary|Number of Other Nervous System Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin|Incident other nervous system cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date.|The case index date was the date of incident other nervous system cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was same as for case|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
831069|NCT01236053|Primary|Number of Other Nervous System (ONS) Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin|Incident ONS cancer. Gabapentin (Gaba.) Exposure Description: With 2 yr lag=Gaba. exposure from cohort entry to 2 yr prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (0.01-1.38 months [mo.]), T 2 (1.39-5.56 mo.), and T 3 (5.57-105.82 mo.). Tertiles without 2 yr lag: T 1 (0.01-1.38 mo.), T 2 (1.39-5.72 mo.), and T 3 (5.73-123.70 mo.). Inestimable OR and 95% CI when no gaba.-exposed cancer cases or controls at the exposure level.|The case index date was the date of incident other nervous system cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was same as for case|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
831070|NCT01236053|Primary|Number of Other Nervous System (ONS) Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions|Incident ONS cancer. Gabapentin (Gaba.) Exposure Description: With 2 year (yr) lag=Gaba. exposure from cohort entry to 2 yr prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (1-2 prescriptions [prescrip.]), T 2 (3-7 prescrip.), T 3 (8-298 prescrip.). Tertiles without 2 yr lag: T 1 (1-2 prescrip.), T 2 (3-7 prescrip.), and T 3 (8-388 prescrip.). Inestimable OR and 95% CI when no gaba.-exposed cancer cases or controls at the exposure level.|The case index date was the date of incident other nervous system cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his cohort entry was same as for case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
831071|NCT01236053|Primary|Number of Other Nervous System Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin|Incident other nervous system cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin prescription from cohort entry to index date. Inestimable OR and 95% CI when no gabapentin-exposed cancer cases or no gabapentin-exposed controls at the exposure level.|The case index date was the date of incident other nervous system cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his cohort entry was the same as case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
831072|NCT01236053|Primary|Number of Bladder Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin|Incident bladder cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile’s with 2 year lag: Tertile 1 (0.1 - 30.0 grams), Tertile 2 (30.1 - 189.0 grams), and Tertile 3 (189.1 - 9600.0 grams). Tertile’s without 2 year lag: Tertile 1 (0.1 - 30.0 grams), Tertile 2 (30.1 - 189.0 grams), and Tertile 3 (189.1 - 11610.0 grams).|The case index date was the date of incident bladder cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
831248|NCT01244906|Secondary|Number of Participants With Non-Relapse Mortality||1 year|||participants|||Number
831073|NCT01236053|Primary|Number of Bladder Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin|Incident bladder cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date.|The case index date was the date of incident bladder cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
831074|NCT01236053|Primary|Number of Bladder Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin|Incident bladder cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile’s with 2 year lag: Tertile 1 (0.01 - 1.38 months), Tertile 2 (1.39 - 5.56 months), and Tertile 3 (5.57 - 105.82 months). Tertile’s without 2 year lag: Tertile 1 (0.01 - 1.38 months), Tertile 2 (1.39 - 5.72 months), and Tertile 3 (5.73 - 123.70 months).|The case index date was the date of incident bladder cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
831075|NCT01236053|Primary|Number of Bladder Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions|Incident bladder cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile’s with 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-7 prescriptions), Tertile 3 (8-298 prescriptions). Tertiles without 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-7 prescriptions), and Tertile 3 (8-388 prescriptions).|The case index date was the date of incident bladder cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
831076|NCT01236053|Primary|Number of Bladder Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin|Incident bladder cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin prescription from cohort entry to index date.|The case index date was the date of incident bladder cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
831077|NCT01236053|Primary|Number of Penile Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin|Incident penile cancer. Gabapentin (Gaba.) Exposure Description: With 2 year (yr) lag=Gaba. exposure from cohort entry to 2 yr prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (0.1-30.0 grams [g]), T 2 (30.1-189.0 g), and T 3 (189.1-9600.0 g). Tertiles without 2 yr lag: T 1 (0.1-30.0 g), T 2 (30.1-189.0 g), and T 3 (189.1-11610.0 g). Inestimable OR and 95% CI when no gaba.-exposed cancer cases or controls at the exposure level.|The case index date was the date of incident penile cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
831078|NCT01236053|Primary|Number of Penile Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin|Incident penile cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date.|The case index date was the date of incident penile cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
831158|NCT01244243|Primary|Arm Motor Fugl-Meyer Test|The Arm Motor Fugl-Meyer test is an assessment of Sensorimotor Recovery After Stroke. It is a 33 item measure with 3 subgroups which are Proximal, Wrist/Hand, and Coordination/Speed. The scaling for each item works on a scale of 0-2 with 0 being not able to be done, 1 being partially done, and 2 being done normally. The scoring goes from 0-66, higher is better, 66 is considered a normal score with no noticable complications in movement.|change from baseline to 1 month post-end treatment, Intention To Treat|||units on a scale||95% Confidence Interval|Mean
831079|NCT01236053|Primary|Number of Penile Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin|Incident penile cancer. Gabapentin (Gaba.) Exposure Description: With 2 year (yr) lag=Gaba. exposure from cohort entry to 2 yr prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (0.01-1.38 months [mo.]), T 2 (1.39-5.56 mo.), and T 3 (5.57-105.82 mo.). Tertiles without 2 yr lag: T 1 (0.01-1.38 mo.), T 2 (1.39-5.72 mo.), and T 3 (5.73-123.70 mo.). Inestimable OR and 95% CI when no gaba.-exposed cancer cases or controls at the exposure level.|The case index date was the date of incident penile cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
831080|NCT01236053|Primary|Number of Penile Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions|Incident penile cancer. Gabapentin (Gaba.) Exposure Description: With 2 year (yr) lag=Gaba. exposure from cohort entry to 2 yr prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (1-2 prescriptions [prescrip.]), T 2 (3-7 prescrip.), T 3 (8-298 prescrip.). Tertiles without 2 yr lag: T 1 (1-2 prescrip.), T 2 (3-7 prescrip.), and T 3 (8-388 prescrip.). Inestimable OR/95% CI when no gaba.-exposed cancer cases or controls at the exposure level.|The case index date was the date of incident penile cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
831081|NCT01236053|Primary|Number of Penile Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin|Incident penile cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin prescription from cohort entry to index date.|The case index date was the date of incident penile cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
831082|NCT01236053|Primary|Number of Breast Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin|Incident breast cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile’s with 2 year lag: Tertile 1 (0.1 - 30.0 grams), Tertile 2 (30.1 - 189.0 grams), and Tertile 3 (189.1 - 9600.0 grams). Tertile’s without 2 year lag: Tertile 1 (0.1 - 30.0 grams), Tertile 2 (30.1 - 189.0 grams), and Tertile 3 (189.1 - 11610.0 grams).|The case index date was the date of incident breast cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
831083|NCT01236053|Primary|Number of Breast Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin|Incident breast cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date.|The case index date was the date of incident breast cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
831084|NCT01236053|Primary|Number of Breast Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin|Incident breast cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile’s with 2 year lag: Tertile 1 (0.01 - 1.38 months), Tertile 2 (1.39 - 5.56 months), and Tertile 3 (5.57 - 105.82 months). Tertile’s without 2 year lag: Tertile 1 (0.01 - 1.38 months), Tertile 2 (1.39 - 5.72 months), and Tertile 3 (5.73 - 123.70 months).|The case index date was the date of incident breast cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
831249|NCT01244906|Secondary|Incidence of Absolute Neutrophil Count (ANC)/Platelet Engraftment|To estimate the incidence of neutrophil and platelet engraftment|Approximately Day 30|||participants|||Number
831085|NCT01236053|Primary|Number of Breast Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions|Incident breast cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile’s with 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-7 prescriptions), Tertile 3 (8-298 prescriptions). Tertiles without 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-7 prescriptions), and Tertile 3 (8-388 prescriptions).|The case index date was the date of incident breast cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
831086|NCT01236053|Primary|Number of Breast Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin|Incident breast cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin prescription from cohort entry to index date.|The case index date was the date of incident breast cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
831087|NCT01236053|Primary|Number of Bone/Joint Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin|Incident bone/joint cancer. Gabapentin (Gaba.) Exposure Description: With 2 year (yr) lag=Gaba. exposure from cohort entry to 2 yr prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (0.1-30.0 grams [g]), T 2 (30.1-189.0 g), and T 3 (189.1-9600.0 g). Tertiles without 2 yr lag: T 1 (0.1-30.0 g), T 2 (30.1-189.0 g), and T 3 (189.1-11610.0 g). Inestimable OR and 95% CI when no gaba.-exposed cancer cases or controls at the exposure level.|The case index date was the date of incident bone/joint cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
831088|NCT01236053|Primary|Number of Bone/Joint Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin|Incident bone/joint cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date.|The case index date was the date of incident bone/joint cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
831089|NCT01236053|Primary|Number of Bone/Joint Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin|Incident bone/joint cancer. Gabapentin (Gaba.) Exposure Description: With 2 year (yr) lag=Gaba. exposure from cohort entry to 2 yr prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (0.01-1.38 months [mo.]), T 2 (1.39-5.56 mo.), and T 3 (5.57-105.82 mo.). Tertiles without 2 yr lag: T 1 (0.01-1.38 mo.), T 2 (1.39-5.72 mo.), and T 3 (5.73-123.70 mo.). Inestimable OR and 95% CI when no gaba.-exposed cases or controls at the exposure level.|The case index date was the date of incident bone/joint cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
831090|NCT01236053|Primary|Number of Bone/Joint Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions|Incident bone/joint cancer. Gabapentin (Gaba.) Exposure Description: With 2 year (yr) lag=Gaba. exposure from cohort entry to 2 yr prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (1-2 prescriptions [prescrip.]), T 2 (3-7 prescrip.), T 3 (8-298 prescrip.). Tertiles without 2 yr lag: T 1 (1-2 prescrip.), T 2 (3-7 prescrip.), and T 3 (8-388 prescrip.). Inestimable OR and 95% CI when no gaba.-exposed cases or controls at the exposure level.|The case index date was the date of incident bone/joint cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
831250|NCT01244906|Primary|Incidence of GVHD|To estimate the incidence of graft-versus-host disease (GVHD) when utilizing post-transplant cyclophosphamide (Cy) and sirolimus for GVHD prophylaxis following reduced intensity allogeneic hematopoietic stem cell transplantation (SCT) in patients with high risk hematologic malignancies.|1 year|||participants|||Number
831091|NCT01236053|Primary|Number of Bone/Joint Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin|Incident bone/joint cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin prescription from cohort entry to index date. Inestimable OR and 95% CI when no gabapentin-exposed cancer cases or no gabapentin-exposed controls at the exposure level.|The case index date was the date of incident bone/joint cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
831092|NCT01236053|Primary|Number of Lung Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin|Incident lung cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile’s with 2 year lag: Tertile 1 (0.1 - 30.0 grams), Tertile 2 (30.1 - 189.0 grams), and Tertile 3 (189.1 - 9600.0 grams). Tertile’s without 2 year lag: Tertile 1 (0.1 - 30.0 grams), Tertile 2 (30.1 - 189.0 grams), and Tertile 3 (189.1 - 11610.0 grams).|The case index date was the date of incident lung cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
831093|NCT01236053|Primary|Number of Lung Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin|Incident lung cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date.|The case index date was the date of incident lung cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
831094|NCT01236053|Primary|Number of Lung Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin|Incident lung cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile’s with 2 year lag: Tertile 1 (0.01 - 1.38 months), Tertile 2 (1.39 - 5.56 months), and Tertile 3 (5.57 - 105.82 months). Tertile’s without 2 year lag: Tertile 1 (0.01 - 1.38 months), Tertile 2 (1.39 - 5.72 months), and Tertile 3 (5.73 - 123.70 months).|The case index date was the date of incident lung cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
831095|NCT01236053|Primary|Number of Lung Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions|Incident lung cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile’s with 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-7 prescriptions), Tertile 3 (8-298 prescriptions). Tertiles without 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-7 prescriptions), and Tertile 3 (8-388 prescriptions).|The case index date was the date of incident lung cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
831096|NCT01236053|Primary|Number of Lung Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin|Incident lung cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin prescription from cohort entry to index date.|The case index date was the date of incident lung cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
831197|NCT01244529|Primary|Lens Centration Acceptance|Investigator evaluated as acceptable (centered/slightly decentered) or unacceptable (substantially decentered). Number of eyes in each category will be reported by lens. This is an aggregate reporting of the lenses, combining the different base curves into a category by lens type. This is done per protocol, due to this primary outcome not being stratified by base curve.|after 15 minutes of contact lens wear|Analysis was on those completed subjects who were enrolled, randomized, and assigned to a study arm.||eyes|eyes||Number
831097|NCT01236053|Primary|Number of Anal Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin|Incident anal cancer. Gabapentin (Gaba.) Exposure Description: With 2 yr lag=Gaba. exposure from cohort entry to 2 yr prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (0.1-30.0 grams [g]), T 2 (30.1-189.0 g), and T 3 (189.1-9600.0 g). Tertiles without 2 yr lag: T 1 (0.1-30.0 g), T 2 (30.1-189.0 g), and T 3 (189.1-11610.0 g). Inestimable OR and 95% CI when no gaba.-exposed cancer cases or controls at the exposure level.|The case index date was the date of incident anal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
831098|NCT01236053|Primary|Number of Anal Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin|Incident anal cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date.|The case index date was the date of incident anal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
831099|NCT01236053|Primary|Number of Anal Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin|Incident anal cancer. Gabapentin (Gaba.) Exposure Description: With 2 year (yr) lag=Gaba. exposure from cohort entry to 2 yr prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (0.01-1.38 months [mo.]), T 2 (1.39-5.56 mo.), and T 3 (5.57 -105.82 mo.). Tertiles without 2 yr lag: T 1 (0.01-1.38 mo.), T 2 (1.39-5.72 mo.), and T 3 (5.73-123.70 mo.). Inestimable OR and 95% CI when no gaba.-exposed cancer cases or controls at the exposure level.|The case index date was the date of incident anal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
831100|NCT01236053|Primary|Number of Anal Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions|Incident anal cancer. Gabapentin (Gaba.) Exposure Description: With 2 year (yr) lag=Gaba. exposure from cohort entry to 2 yr prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (1-2 prescriptions [prescrip.]), T 2 (3-7 prescrip.), T 3 (8-298 prescrip.). Tertiles without 2 yr lag: T 1 (1-2 prescrip.), T 2 (3-7 prescrip.), and T 3 (8-388 prescrip.). Inestimable OR and 95% CI when no gaba.-exposed cancer cases or controls at the exposure level.|The case index date was the date of incident anal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
831101|NCT01236053|Primary|Number of Anal Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin|Incident Anal cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin prescription from cohort entry to index date.|The case index date was the date of incident anal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
831102|NCT01236053|Primary|Number of Stomach Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin|Incident stomach cancer. Gabapentin (Gaba.) Exposure Description: With 2 year (yr) lag=Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (0.1-30.0 grams [g]), T 2 (30.1-189.0 g), and T 3 (189.1-9600.0 g). Tertiles without 2 yr lag: T 1 (0.1-30.0 g), T 2 (30.1-189.0 g), and T 3 (189.1-11610.0 g). Inestimable OR and 95% CI when no gaba.-exposed cancer cases or controls at the exposure level.|The case index date was the date of incident stomach cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
831321|NCT01245140|Secondary|Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Screening, Baseline, and EOT (Week 24)|SBP and DBP were assessed at Screening, Baseline, and EOT.|Screening, Baseline, and EOT (Week 24)|Safety Population. Only participants available at the specified time points were analyzed (n=X, X).||Millimeters of mercury (mmHg)||Standard Deviation|Mean
831103|NCT01236053|Primary|Number of Stomach Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin|Incident stomach cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date.|The case index date was the date of incident stomach cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
831104|NCT01236053|Primary|Number of Stomach Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin|Incident stomach cancer. Gabapentin (Gaba.) Exposure Description: With 2 year (yr) lag=Gaba. exposure from cohort entry to 2 yr prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (0.01-1.38 months [mo.]), T 2 (1.3-5.56 mo.), and T 3 (5.57-105.82 mo.). Tertiles without 2 yr lag: T 1 (0.01-1.38 m.), T 2 (1.39-5.72 mo.), and T 3 (5.73-123.70 mo.). Inestimable OR and 95% CI when no gaba.-exposed cancer cases or controls at the exposure level.|The case index date was the date of incident stomach cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
831105|NCT01236053|Primary|Number of Stomach Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions|Incident stomach cancer. Gabapentin (Gaba.) Exposure Description: With 2 year (yr) lag=Gaba. exposure from cohort entry to 2 yr prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (1-2 prescriptions [prescrip]), T 2 (3-7 prescrip), T 3 (8-298 prescrip). Tertiles without 2 yr lag: T 1 (1-2 prescrip), T 2 (3-7 prescrip), and T 3 (8-388 prescrip). Inestimable OR and 95% CI when no gaba.-exposed cancer cases or controls at the exposure level.|The case index date was the date of incident stomach cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
831106|NCT01236053|Primary|Number of Stomach Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin|Incident stomach cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin prescription from cohort entry to index date.|The case index date was the date of incident stomach cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
831107|NCT01236053|Primary|Number of All-Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin|Incidence of all cancers. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile’s with 2 year lag: Tertile 1 (0.1 - 30.0 grams), Tertile 2 (30.1 - 189.0 grams), and Tertile 3 (189.1 - 9600.0 grams). Tertile’s without 2 year lag: Tertile 1 (0.1 - 30.0 grams), Tertile 2 (30.1 - 189.0 grams), and Tertile 3 (189.1 - 11610.0 grams).|The case index date was the date of incident cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
831108|NCT01236053|Primary|Number of All-Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin|Incidence of all cancers. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date.|The case index date was the date of incident cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
831159|NCT01244243|Primary|Action Research Arm Test|The Action Research Arm Test is a 19 item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point ordinal scale ranging from: 3: Performs test normally 2: Completes test, but takes abnormally long or has great difficulty 1: Performs test partially 0: Can perform no part of test. The test is used to determine upper limb function, 0-57 points with higher is better, 57 is the highest score indicating normal arm movement.|change from baseline to 1 month post-end treatment, Intention To Treat|||units on a scale||95% Confidence Interval|Mean
831109|NCT01236053|Primary|Number of All-Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin|Incidence of all cancers. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile’s with 2 year lag: Tertile 1 (0.01 - 1.38 months), Tertile 2 (1.39 - 5.56 months), and Tertile 3 (5.57 - 105.82 months). Tertile’s without 2 year lag: Tertile 1 (0.01 - 1.38 months), Tertile 2 (1.39 - 5.72 months), and Tertile 3 (5.73 - 123.70 months).|The case index date was the date of incident cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
831110|NCT01236053|Primary|Number of All-Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions|Incidence of all cancers. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile’s with 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-7 prescriptions), Tertile 3 (8-298 prescriptions). Tertiles without 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-7 prescriptions), and Tertile 3 (8-388 prescriptions).|The case index date was the date of incident cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
831111|NCT01236053|Primary|Number of All-Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin|Incidence of all cancers. Gabapentin Exposure Description: Without 2 year lag = Gabapentin prescription from cohort entry to index date. With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer).|The case index date was the date of incident cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
831112|NCT01236105|Secondary|Time to Maximum Plasma Concentration (Tmax) for LY2624803 and the Metabolite, LSN2797276|Tmax, estimated for both LY2624803 and the metabolite LSN2797276.|Predose and up to day 4|All participants who received at least 1 dose of LY2624803 and have evaluable pharmacokinetic (PK) data.||hours (h)||Full Range|Median
831113|NCT01236105|Primary|Maximum Concentration (Cmax) for LY2624803 and the Metabolite, LSN2797276,|Cmax estimated for both LY2624803 and the metabolite LSN2797276.|Predose and up to Day 4|All participants who received at least 1 dose of LY2624803 and have evaluable pharmacokinetic (PK) data.||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
831114|NCT01236105|Primary|Area Under the Concentration-Time Curve (AUC) for LY2624803 and the Metabolite LSN2797276|AUC from time 0, extrapolated to infinity, estimated for both LY2624803 and the metabolite LSN2797276.|Predose and up to Day 4|All participants who received at least 1 dose of LY2624803 and have evaluable pharmacokinetic (PK) data.||nanogram*hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
831115|NCT01236118|Primary|Number of Participants With Adverse Events (AEs) [Clinically Significant Events]|Data presented are the number of participants who experienced 1 or more AEs (all causalities and drug-related) and serious AEs (SAEs). A summary of SAEs and other non-serious AEs, regardless of causality is located in the Reported Adverse Events section of this report.|Baseline through study completion (up to Week 56)|All enrolled participants.||participants|||Number
831116|NCT01236170|Secondary|Wheelchair Activity||over a two week period following baseline||||||
831117|NCT01236170|Secondary|Participation in Society|"We assessed participation in society with a modified version of the Craig Handicap Assessment and Reporting Technique Short Form (CHART-SF). The CHART was designed to provide a simple measure of involvement in life situations (“In a typical week, how many days do you get out of your house and go somewhere?”) with sub-scales measuring physical independence, cognitive independence, mobility, occupation, social integration and economic self-sufficiency. The CHART-SF produces scores ranging from 0 (severe handicap) to 100 (no handicap) for each of the sub-scales and a total score ranging from 0-600. The CHART-SF is the most widely used participation measure in rehabilitation research. It has been used in various ethnic groups, and has well-established psychometric properties (test-retest reliability = .93; inter-rater reliability = .83). We dichotomized into Disabled and Not Disabled where disabled are those with a CHART score <100, and not disabled are those with a CHART score >=100"|Measured at baseline|452/482 participants were included in this analysis because 30 participants had missing data.||participants|||Number
831118|NCT01236170|Secondary|Satisfaction With Prescribed Wheelchair|We assessed Satisfaction with patients’ prescribe wheelchair using the Quebec User Evaluation of Satisfaction with assistive Technology ( (QUEST). We used an 8-item subset of the QUEST to assess patients’ satisfaction with their wheelchair. QUEST is the first and only standardized satisfaction assessment tool that was designed specifically for assistive technology devices. Its’ development was based on major theoretical models of assistive technology. The QUEST has been widely cited and used in clinical and research settings, and demonstrates strong psychometric properties (Cronbach’s alpha = .82). The 8 item subset focuses specifically on patients’ satisfaction with different aspects of their wheelchair (e.g., “How satisfied are you with the dimensions (size, height, length, width) of your assistive device?”). Responses range from 1(not satisfied at all) to 5(very satisfied). Cronbach’s alpha = .80 for the 8-item wheelchair subset. We chose to eliminate the other four items|one time use, at baseline|||units on a scale||Standard Deviation|Mean
831119|NCT01236170|Secondary|Satisfaction With Wheelchair Service Delivery|We assessed Satisfaction with Wheelchair Service Delivery using the Client Satisfaction Questionnaire (CSQ-8). The CSQ-8 is an 8-item, easily administered and scored measure of client satisfaction with services (e.g., “How would you rate the quality of service you have received?”). For the purpose of this study, we asked patients to focus specifically on satisfaction with service at their SCI or AL wheelchair clinic. The scale is unidimensional, yielding a homogenous estimate of general satisfaction with services. It is scored by summing the individual items and produces a score ranging from 8-32, with higher scores indicating greater satisfaction. The CSQ-8 has been extensively used in a variety of healthcare settings, operates similarly across ethnic groups, and demonstrates excellent psychometric properties (Cronbach’s alpha = .83-.93).|one time use, at baseline|||units on a scale||Standard Deviation|Mean
831120|NCT01236170|Primary|Quality of Life|We will assess QOL with the Veterans RAND 12 Item Health Survey (VR-12)and two additional physical function items designed for patients with SCI. Eight QOL domains are assessed, including physical functioning, vitality, role limitations due to physical problems, role limitations due to emotional problems, bodily pain, general health, social functioning, and mental health. The VR-12 has been used extensively with Veterans in a variety of health domains and has shown to be reliable and valid in ambulatory care populations (Cronbach’s alpha= .83-.85). The additional two items were added because previous research demonstrated that existing measures of physical function in the VR12 are not appropriate to patients with SCI and are not able to reveal differences in physical function among SCI patients. We assessed physical QOL and mental QOL, both scales range from 0 (worst possible outcome) to 100 (best possible outcome).|Measured at baseline|Only 468/482 participants were included in this analysis due to 14 participants having missing data.||units on a scale||Standard Deviation|Mean
831121|NCT01236196|Primary|Pain Intensity|Pain Intensity Rating, ranging from 0-6, higher score indicates greater pain intensity|Baseline, 46 weeks|OEF/OIF/OND military veterans with chronic pain||units on a scale||Standard Deviation|Mean
831122|NCT01236196|Primary|Pain Behavior|Pain behavior measured as total score on Pain Behavior Checklist (range 0-6), higher score indicating more pain behavior|Baseline, 46 weeks|OEF/OIF/OND military veterans with chronic pain||units on a scale||Standard Deviation|Mean
831123|NCT01236196|Primary|Depressive Symptoms|Depressive symptoms, measured on Beck Depression Inventory-II (total score with range from 0 to 63)|Baseline, 46 weeks|OEF/OIF/OND military veterans with chronic pain||units on a scale||Standard Deviation|Mean
831124|NCT01236196|Primary|Level of Functioning|Physical health (quality of life), reported on the SF-12, range 0-100, higher scores reflect better quality of life and higher level of functioning|Baseline, 46 weeks|OEF/OIF/OND military veterans with chronic pain||units on a scale||Standard Deviation|Mean
831125|NCT01242085|Primary|Alignment of Knee - Measured Mechanical Axis From CT Data|the mean knee mechanical axis was determined from 3D CT data - negative value designates varus alignment|postoperatively - CT done within 1 week of surgery|all participants who completed the study||degrees||95% Confidence Interval|Mean
831126|NCT01242085|Secondary|Surgical Time|the difference between the average surgical time will be determined and compared with 95% CI|intraoperative surgical time|particpants who completed study||delta between means in minutes||95% Confidence Interval|Mean
831127|NCT01242111|Secondary|Percent Change From Baseline in Respiratory Function Test FVC During the Pilot Trial (MOR-002) and Current Extension Trial (MOR-100).|Percent Change from baseline in Forced Vital Capacity.|Baseline and every 12 weeks for up to 72 weeks during the MOR-002 pilot trial and every 24 weeks for up to 192 weeks during the MOR-100 extension trial|Intent-to-Treat population (all subjects who enrolled in the study). The analysis was based on observed cases.||percentage change||Standard Deviation|Mean
831128|NCT01242111|Secondary|Percent Change From Baseline in Respiratory Function Test MVV During the Pilot Trial (MOR-002) and Current Extension Trial (MOR-100).|Percent Change from baseline in Maximum Voluntary Ventilation.|Baseline and every 12 weeks for up to 72 weeks during the MOR-002 pilot trial and every 24 weeks for up to 192 weeks during the MOR-100 extension trial|Intent-to-Treat population (all subjects who enrolled in the study). The analysis was based on observed cases.||percentage change||Standard Deviation|Mean
831129|NCT01242111|Secondary|Percent Change From Baseline in Urine Keratan Sulfate (uKS) Levels During the Pilot Trial (MOR-002) and Current Extension Trial (MOR-100).|Percent Change from baseline in Normalized Urine KS. The percent change was calculated (Week X value - baseline value)/baseline value *100%|Baseline and every 12 weeks for up to 72 weeks during the MOR-002 pilot trial and every 24 weeks for up to 168 weeks during the MOR-100 extension trial|Intent-to-Treat population (all subjects who enrolled in the study). The analysis was based on observed cases.||percentage change||Standard Deviation|Mean
831130|NCT01242111|Secondary|Change in Baseline in Endurance as Measured by the 3 Minute Stair Climb During the Pilot Trial (MOR-002) and Current Extension Trial (MOR-100).|Change from baseline in the 3-minute Stair Climb Test (3MSCT). Patients walked up stairs that have a railing, which could be used for support, for 3 minutes, with the number of stairs climbed recorded. The test result was the number of steps climbed per minute.|Baseline and every 12 weeks for up to 72 weeks during the MOR-002 pilot trial and every 24 weeks for up to 192 weeks during the MOR-100 extension trial|Intent-to-Treat population (all subjects who enrolled in the study). One patient was developmentally unable to perform the 3MSCT and the test scores were set to missing. The analysis was based on observed cases.||steps/min||Standard Deviation|Mean
831131|NCT01242111|Secondary|Change From Baseline in Endurance as Measured by the 6-minute Walk Test During the Pilot Trial (MOR-002) and Current Extension Trial (MOR-100).|Change from baseline in meters in 6-minute Walk Test. As a measure of endurance, a 6-minute walk test (6MWT) was performed according to the American Thoracic Society Guidelines. Patients were instructed to walk as far as possible in 6 minutes.|Baseline and every 12 weeks for up to 72 weeks during the MOR-002 pilot trial and every 24 weeks for up to 192 weeks during the MOR-100 extension trial|Intent-to-Treat population (all subjects who enrolled in the study). Two patients were either physically (score was designated as 0 m) or developmentally (score was set to missing) unable to perform the 6MWT. The analysis was based on observed cases.||meters||Standard Deviation|Mean
831132|NCT01242111|Primary|Safety Evaluation|"The primary objective of the study is to evaluate the safety of weekly infusions of BMN 110; the safety variables included Adverse Events (AEs).
The primary outcome measure data is presented in more detail under the Adverse Events section."|Entire Study Period, up to 240 weeks|The primary outcome measure data is presented in more detail under the Adverse Events section.||participants|||Number
831133|NCT01242176|Secondary|Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)|"Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 to the time of the last quantifiable data point.
Note the standard deviation is actually the CV (%)."|30 minutes (mins) before drug administration and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set included all subjects who took at least one dose of study medication and who provided evaluable data for at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of PK.||nmol*h/L||Standard Deviation|Mean
831134|NCT01242176|Primary|Maximum Measured Concentration (Cmax)|"Maximum measured concentration of empagliflozin (empa) in plasma.
Note the standard deviation is actually the CV (%)."|30 minutes (mins) before drug administration and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set included all subjects who took at least one dose of study medication and who provided evaluable data for at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of PK.||nmol/L||Standard Deviation|Mean
831135|NCT01242176|Primary|Area Under the Curve 0 to Infinity (AUC0-∞)|"Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity.
Note the standard deviation is actually the coefficient of variation (CV (%))."|30 minutes (mins) before drug administration and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set included all subjects who took at least one dose of study medication and who provided evaluable data for at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of PK.||nmol*h/L||Standard Deviation|Mean
831136|NCT01242371|Secondary|Measurement of Gliadin and Casein Antibody Levels||16 weeks (baseline prior to placebo run in to week 14)||||||
831137|NCT01242371|Secondary|Gastrointestinal Functioning From the Beginning to the End of the Double-blind Treatment Phase Weeks 0-14|"Self report rating of difficulty moving bowels on a 4 point scale from no difficulty to severe difficulty"|14 weeks (weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 & 14)||||||
831138|NCT01242371|Primary|Change in Positive and Negative Syndrome Scale (PANSS) Score From the Start to the End of the Double-blind Treatment Phase (Week 0 to Week 14)|The Positive and Negative Syndrome Scale (PANSS) measures psychiatric symptomatology, especially related to psychosis. The complete PANSS contains ratings for 30 symptoms, including 7 positive symptoms, 7 negative symptoms, and 16 general psychiatric symptoms. The severity of each symptom is rated on a scale ranging from 1 (minimal) to 7 (extreme); higher scores indicate increased symptomatology. Total PANSS scores include scores from all categories and range from 30 to 210 units on a scale.|14 weeks (week 0 to week 14)|Week 0 data is based on the number of participants in the probiotic supplement group (n=33) and the placebo group (n=32) who began the treatment phase. Week 14 data is based on the number of participants in the probiotics supplement group (n=31) and the placebo group (n=27) who completed the treatment phase.||units on a scale||Standard Deviation|Mean
831139|NCT01243892|Secondary|Annualized Height Velocity in Response to rhGH Treatment Using the NuSpin Device During the Second Year of Therapy|The annualized height velocity (cm/yr) for second year was calculated as: [(height in cm at t24 – height in cm at t12) divided by (date at t24 – date at t12)] multiplied by 365.25, where, t12 is the 1-year measurement visit and t24 is the 2-year measurement visit.|Month 12 to Month 24 (Year 1 to Year 2)|Data for this outcome measure was not collected as the study was terminated prematurely due to slow enrollment.|||||
831140|NCT01243892|Secondary|Annualized Height Velocity in Response to rhGH Treatment Using the NuSpin Device for First Year of Treatment|The annualized height velocity (cm/yr) after 1 year was calculated as: [(height in cm at t12 – height in cm at t0) divided by (date at t12 – date at t0)] multiplied by 365.25, where, t0 is the baseline measurement visit and t12 is the 1-year measurement visit.|Baseline up to Month 12 (Year 1)|Data for this outcome measure was not collected as the study was terminated prematurely due to slow enrollment.|||||
831141|NCT01243892|Primary|Annualized Height Velocity in Response to rhGH Treatment Using the NuSpin Device After Two Years of Treatment|The annualized height velocity (cm per year [cm/yr]) over 2 years was calculated as: [(height in cm at t24 minus (–) height in cm at t0) divided by (date at t24 – date at t0)] multiplied by 365.25, where, t0 is the baseline measurement visit and t24 is the 2-year measurement visit.|Baseline up to Month 24 (Year 2)|Data for this outcome measure was not collected as the study was terminated prematurely due to slow enrollment.|||||
831142|NCT01243944|Secondary|Estimated Duration of the Complete Hematological Remission|"Duration of the complete hematological remission is defined as the time from the first occurrence of complete hematological remission until the date of the first documented progression (end of response).
Kaplan-Meier estimates are provided for duration of complete hematological remission."|Through study completion, analysis was conducted when all patients had completed the Week 80 visit or discontinued the study|Full Analysis Set (FAS) comprises all patients to whom study treatment had been assigned by randomization. Duration of response was pre-specified in the protocol to be analyzed for the ruxolitinib arm only considering the study design which allowed crossover for the BAT arm beginning at Week 32.||probability||95% Confidence Interval|Number
831143|NCT01243944|Secondary|The Percentage of Subjects Achieving a Durable Complete or Partial Clinicohematologic Response at Week 48|Durable Complete or Partial Clinicohematologic Response was defined as any subject who achieved complete or partial clinicohematologic response per the European LeukemiaNet modified criteria for response in polycythemia vera at Week 32 and maintained that response 48 weeks after randomization.|48 Weeks|Full Analysis Set (FAS) comprises all patients to whom study treatment had been assigned by randomization.||percentage of participants|||Number
831144|NCT01243944|Secondary|The Percentage of Subjects Who Achieved Overall Clinicohematologic Response at Week 32|Overall Clinicohematologic Response is defined as any subject who achieved a complete or partial clinicohematologic response per the European LeukemiaNet modified criteria for response in polycythemia vera (PV). A Complete Response (CR) is defined as: hematocrit control, spleen volume reduction at least 35% from baseline, platelet count less than or equal to 400 x 10(9)/L, and white blood cell count less than or equal to 10 x 10(9)/L. A Partial Response (PR) is defined as hematocrit control or response in all 3 of the other criteria.|32 Weeks|Full Analysis Set (FAS) comprises all patients to whom study treatment had been assigned by randomization.||percentage of participants|||Number
831145|NCT01243944|Secondary|Estimated Duration of the Primary Response|"Duration of the primary response is defined as the time from the first occurrence when both components of the primary endpoint are met until the date of the first documented disease progression (end of response).
Kaplan-Meier estimates are provided for duration of primary response."|Through study completion, analysis was conducted when all patients had completed the Week 80 visit or discontinued the study|Full Analysis Set (FAS) comprises all patients to whom study treatment had been assigned by randomization. Duration of response was pre-specified in the protocol to be analyzed for the ruxolitinib arm only considering the study design which allowed crossover for the BAT arm beginning at Week 32.||probability||95% Confidence Interval|Number
831146|NCT01243944|Secondary|The Percentage of Subjects Who Achieved Durable Spleen Volume Reduction at Week 48|Durable Spleen Volume Reduction was defined as a subject who achieved at least 35% reduction from baseline in spleen volume at Week 32 and maintained that response 48 weeks after randomization.|48 Weeks|Full Analysis Set (FAS) comprises all patients to whom study treatment had been assigned by randomization.||percentage of participants||95% Confidence Interval|Number
831147|NCT01243944|Secondary|The Percentage of Subjects Who Achieved a Durable Hematocrit Control at Week 48|Durable Hematocrit Control was defined as any subject who achieved phlebotomy eligibility independence from Week 8 to Week 32 and maintained hematocrit control up to 48 weeks after randomization.|48 Weeks|Full Analysis Set (FAS) comprises all patients to whom study treatment had been assigned by randomization.||percentage of participants||95% Confidence Interval|Number
831148|NCT01243944|Secondary|The Percentage of Subjects Who Achieved a Durable Complete Hematological Remission at Week 48|Durable Complete Hematological Remission was defined as any subject who achieved Complete Hematological Remission at Week 32 and maintained their response up to 48 weeks after randomization.|48 Weeks|Full Analysis Set (FAS) comprises all patients to whom study treatment had been assigned by randomization.||percentage of participants||95% Confidence Interval|Number
831149|NCT01243944|Secondary|The Percentage of Subjects Achieving Complete Hematological Remission at Week 32|Complete Hematological Remission at Week 32 was defined as any subject who achieved hematocrit control with a platelet count less than or equal to 400 X 10^9/L and a white blood cell count less than or equal to 10 X 10^9/L.|32 Weeks|Full Analysis Set (FAS) comprises all patients to whom study treatment had been assigned by randomization.||percentage of participants||95% Confidence Interval|Number
831150|NCT01243944|Secondary|The Percentage of Subjects Achieving a Durable Primary Response at Week 48|Durable Primary Response was defined as any subject who achieved the primary outcome measure and who maintained their response up to 48 weeks after randomization.|48 Weeks|Full Analysis Set (FAS) comprises all patients to whom study treatment had been assigned by randomization.||percentage of participants||95% Confidence Interval|Number
831151|NCT01243944|Primary|The Percentage of Subjects Achieving a Primary Response at Week 32|Primary response was defined as having achieved hematocrit control (the absence of phlebotomy eligibility beginning at the Week 8 visit and continuing through Week 32) and Spleen Volume Reduction (a greater than or equal to 35% reduction from baseline in spleen volume at Week 32).|32 Weeks|Full Analysis Set (FAS) comprises all patients to whom study treatment had been assigned by randomization.||percentage of participants||95% Confidence Interval|Number
831152|NCT01244061|Secondary|7-day Point Prevalence (PP) of Abstinence at Weeks 12, 24, and 52|The secondary endpoint of 7-day point prevalence of smoking cessation was determined by evaluating a participant's cigarette smoking status, and other nicotine (and/or other tobacco) use, based on the “last 7 days” questions in the Nicotine Use Inventory. Additionally, a participant was not considered a responder if the expired CO was >10 ppm at the time point being summarized. Participants were considered responders independently at each visit.|Weeks 12, 24 and 52|The FAS included all participants as the primary participant population for efficacy analyses in this study and was defined as all participants who had received ≥1 dose, including partial doses, of randomized study drug.||Percentage of participants|||Number
831153|NCT01244061|Secondary|CAR From Week 9 Through Week 24|The percentage of participants who, from Week 9 through Week 24, reported no smoking (Weeks 9 through 24) and no use of other nicotine-containing products (Weeks 9 through 12), or no use of other tobacco products (Weeks 13 through 24), since the last study visit/last contact (on the Nicotine Use Inventory) and who did not have CO >10 ppm at any of these visits during this time frame.|Week 9 through Week 24|The FAS included all participants as the primary participant population for efficacy analyses in this study and was defined as all participants who had received ≥1 dose, including partial doses, of randomized study drug.||Percentage of participants|||Number
831154|NCT01244061|Secondary|CAR From Week 9 Through Week 52|The percentage of participants who, from Week 9 through Week 52, reported no smoking (Weeks 9 through 52) and no use of other nicotine-containing products (Weeks 9 through 12), or no use of other tobacco products (Weeks 13 through 52), since the last study visit/last contact (on the Nicotine Use Inventory) and who did not have CO >10 ppm at any of these visits during this time frame.|Week 9 through Week 52|The FAS included all participants as the primary participant population for efficacy analyses in this study and was defined as all participants who had received ≥1 dose, including partial doses, of randomized study drug.||Percentage of participants|||Number
831155|NCT01244061|Primary|Continuous Abstinence Rate (CAR) From Week 9 Through Week 12|The percentage of participants who, from Week 9 through Week 12, reported no smoking and no use of other nicotine-containing products since the last study visit/last contact (on the Nicotine Use Inventory) and who did not have carbon monoxide (CO)> 10ppm at any visits during this time frame.|Week 9 through Week 12|The Full Analysis Set (FAS) included all participants as the primary participant population for efficacy analyses in this study and was defined as all participants who had received ≥1 dose, including partial doses, of randomized study drug.||Percentage of participants|||Number
831156|NCT01244126|Secondary|Maximum PAED Score|"Maximum score on the Pediatric Anesthesia Emergence delirium scale. This has 5 items ranging from 1-4 and higher scores indicate greater emergence delirium.
1. eye contact with care giver ,score 1-4, purposeful actions 1-4, aware of surrounding 1-4,restless 1-4, inconsolable 1-4, Maximum score 20."|Upon arrival in the PACU, and at 5, 10, 15, 30, 45, 60 minutes and at discharge|The sample size was based on the assumption that the pain scores in the intranasal fentanyl group would be similar to those in previously published data||units on a scale||Standard Deviation|Mean
831160|NCT01244412|Primary|Number of Participants Who Have an Acceptable Image (Image Score of 3 or Higher) of Their Eye With the Hand Held Camera|"Will determine if the hand held camera is comparable to the traditional table mount camera in quality of images. The quality of the image of the participant's eye taken with the hand held camera will be compared to the quality of the image taken with the table mount camera using the following scale. We will determine the number of participants who have a score of 3 or higher.
Scale Image scored as follows
Unacceptable: cannot see fundus detail
Unacceptable: fundus detail visualized, but inadequate for meaningful analysis
Acceptable: fundus detail visualized to make general comments, modest improvement image would be of sufficient quality for use
Good: fundus detail visualized, meaningful analysis possible, std photo superior
Excellent: fundus detail visualized as well as std photo
Superior: fundus detail of higher quality than std photo"|estimated 3 months|||participants|||Number
831161|NCT01244425|Secondary|Median Total Volume of Postoperative Drainage Fluid Within 48 Hours After Surgery||Within 48 hours after surgery|"Full analysis (data) set
Participants who received a drain and for whom the volume for the first 48 hours after surgery is available"||mL||Full Range|Median
831162|NCT01244425|Secondary|Percentage of Participants With Transfusion Requirements Until Discharged From Surgical Ward|Transfusions administered included whole blood, packed red blood cells, fresh frozen plasma, and thrombocyte concentrate.|Intra- and postoperative until discharged from surgical ward|Full analysis (data) set||percentage of participants||95% Confidence Interval|Number
831163|NCT01244425|Secondary|Percentage of Participants With Postoperative Rebleeding|Rebleeding until discharged from the surgical ward, defined as any rebleeding from the treated liver resection surface requiring surgical reexploration|Postoperative until discharged from surgical ward|Full analysis (data) set||Percentage of participants||95% Confidence Interval|Number
831164|NCT01244425|Secondary|Percentage of Participants With Intraoperative Rebleeding After Occurrence of Hemostasis|Intraoperative rebleeding from the treated liver resection surface after occurrence of hemostasis.|Intraoperative day 0|Full analysis (data) set||percentage of participants||95% Confidence Interval|Number
831165|NCT01244425|Secondary|Percentage of Participants With Intraoperative Hemostasis at 10 Minutes After Application of the Randomized Treatment|Hemostasis defined as no visible bleeding on the liver resection surface (liver surgical site) after treatment application. Hemostasis had to be maintained until surgical closure. Time recording started with treatment application, ie, with the start of spraying Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) or with the application of manual compression.|10 minutes after start of treatment application|Full analysis (data) set||percentage of participants||95% Confidence Interval|Number
831166|NCT01244425|Secondary|Percentage of Participants With Intraoperative Hemostasis at 8 Minutes After Application of the Randomized Treatment|Hemostasis defined as no visible bleeding on the liver resection surface (liver surgical site) after treatment application. Hemostasis had to be maintained until surgical closure. Time recording started with treatment application, ie, with the start of spraying Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) or with the application of manual compression.|8 minutes after start of treatment application|Full analysis (data) set||percentage of participants||95% Confidence Interval|Number
831167|NCT01244425|Secondary|Percentage of Participants With Intraoperative Hemostasis at 6 Minutes After Application of the Randomized Treatment|Hemostasis defined as no visible bleeding on the liver resection surface (liver surgical site) after treatment application. Hemostasis had to be maintained until surgical closure. Time recording started with treatment application, ie, with the start of spraying Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) or with the application of manual compression.|6 minutes after start of treatment application|Full analysis (data) set||percentage of participants||95% Confidence Interval|Number
831168|NCT01244425|Primary|Percentage of Participants With Intraoperative Hemostasis at 4 Minutes After Treatment Application|"Hemostasis defined as no visible bleeding on the liver resection surface (liver surgical site) after treatment application. Hemostasis had to be maintained until surgical closure. Time recording started with treatment application, ie, with the start of spraying Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) or with the application of manual compression.
The following were regarded as treatment failures:
No hemostasis achieved at 4 minutes post treatment application (for the FS VH S/D 500 s-apr arm, the “time to hemostasis” was used; a time window of +5 seconds was acceptable for showing a success)
Additional hemostatic treatment (ie, hemostatics in addition to the randomized treatment) was required
Reapplication of FS VH S/D 500 s-apr after 4 minutes
Intraoperative rebleeding after the first 4 minutes of the observation period"|4 minutes post start of treatment application|full analysis (data) set (FAS)||percentage of participants||95% Confidence Interval|Number
831173|NCT01244490|Secondary|Columbia-Suicide Severity Rating Scale (C-SSRS)|C-SSRS is a semi-structured interview that captures the occurence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale. Outcome measure is at 12 weeks for ages 6-12 years and at 15 weeks for ages 13-17 years.|Up to 12 weeks for children aged 6-12 years and up to 15 weeks for adolescents aged 13-17 years|SP||participants|||Number
831174|NCT01244490|Secondary|Structure Side-Effect Questionnaire|The Structured Side-effect Questionnaire is a simple checklist of 17 side effects. The subject indicates whether a side effect has occurred since the last visit by marking ‘yes’ on the checklist for each of the events listed. Outcome measure is at 12 weeks for ages 6-12 years and at 15 weeks for ages 13-17 years.|Up to 12 weeks for children aged 6-12 years and up to 15 weeks for adolescents aged 13-17 years|Safety Population||participants|||Number
831175|NCT01244490|Secondary|Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRS-C) Total Score at Weeks 10/13 - LOCF|The BPRS-C characterizes childhood behavioral and emotional symptomatology. A total of 21 items are rated on a scale from 0 (not present) to 6 (extremely severe) with a total score ranging from 0 to 126. A decrease in score indicates a reduction in psychopathology. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.|Baseline and up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years|Safety Population defined as of randomized subjects who took at least 1 dose of investigational product.||units on a scale||Standard Deviation|Mean
831176|NCT01244490|Secondary|Change From Baseline in the WFIRS-P Risk Domain Score at Week 10/13 - LOCF|The WFIRS-P Risk Domain is the mean of 10 items, ranging from 0 (never/not at all) to 3 (very often/very much). Higher scores indicate greater functional impairment. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.|Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years|Full Analysis Set. If more than 30% of items used to derive the score were missing, the corresponding score was considered as missing.||units on a scale||Standard Error|Least Squares Mean
831177|NCT01244490|Secondary|Change From Baseline in the WFIRS-P Social Domain Score at Week 10/13 - LOCF|The WFIRS-P Social Domain is the mean of 7 items, ranging from 0 (never/not at all) to 3 (very often/very much). Higher scores indicate greater functional impairment. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.|Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years|Full Analysis Set. If more than 30% of items used to derive the score were missing, the corresponding score was considered as missing.||units on a scale||Standard Error|Least Squares Mean
831178|NCT01244490|Secondary|Change From Baseline in the WFIRS-P Child Self-Concept Domain Score at Week 10/13 - LOCF|The WFIRS-P Child Self-Concept Domain is the mean of 3 items, ranging from 0 (never/not at all) to 3 (very often/very much). Higher scores indicate greater functional impairment. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.|Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years|Full Analysis Set. If more than 30% of items used to derive the score were missing, the corresponding score was considered as missing.||units on a scale||Standard Error|Least Squares Mean
831179|NCT01244490|Secondary|Change From Baseline in the WFIRS-P Life Skills Domain Score at Week 10/13 - LOCF|The WFIRS-P Life Skills Domain is the mean of 10 items, ranging from 0 (never/not at all) to 3 (very often/very much). Higher scores indicate greater functional impairment. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.|Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years|Full Analysis Set. If more than 30% of items used to derive the score were missing, the corresponding score was considered as missing.||units on a scale||Standard Error|Least Squares Mean
831180|NCT01244490|Secondary|Change From Baseline in the WFIRS-P Behavior in School Domain Score at Week 10/13 - LOCF|The WFIRS-P Behavior in School Domain is the mean of 6 items, ranging from 0 (never/not at all) to 3 (very often/very much). Higher scores indicate greater functional impairment. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.|Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years|Full Analysis Set. If more than 30% of items used to derive the score were missing, the corresponding score was considered as missing.||units on a scale||Standard Error|Least Squares Mean
831181|NCT01244490|Secondary|Change From Baseline in the WFIRS-P Academic Performance Domain Score at Week 10/13 - LOCF|The WFIRS-P Academic Performance Domain is the mean of 4 items, ranging from 0 (never/not at all) to 3 (very often/very much). Higher scores indicate greater functional impairment. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.|Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years|Full Analysis Set. If more than 30% of items used to derive the score were missing, the corresponding score was considered as missing.||units on a scale||Standard Error|Least Squares Mean
831182|NCT01244490|Secondary|Change From Baseline in the WFIRS-P Global Score at Week 10/13 - LOCF|The WFIRS-P Global Score is the mean of 50 items, ranging from 0 (never/not at all) to 3 (very often/very much). Higher scores indicate greater functional impairment. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.|Baseline and Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years|Full Analysis Set. If more than 30% of items used to derive the score were missing, the corresponding score was considered as missing.||units on a scale||Standard Error|Least Squares Mean
831183|NCT01244490|Secondary|Health Utilities Index-2/3 (HUI 2/3) Scores - LOCF|HUI is used to describe health status and to obtain utility scores by collecting data using one or more questionnaires in formats selected to match the specific study design criteria. Scoring ranges from 0.00 (dead) to 1.00 (perfect health). Higher scores represent better health status. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.|Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years|Full Analysis Set. Not all subjects in the FAS population had data for this outcome.||units on a scale||Standard Deviation|Mean
831251|NCT01244984|Secondary|Number of Rescue Medication Inhalations|Salbutamol inhaler was used as the rescue medication. Participants entered the number of rescue medication inhalations in the patient diary twice daily (morning and evening).|Baseline up to Week 52|ITT Population. The number of participants analyzed depends on the number of participants remaining in the indaicated time period.||Number of inhalations||Standard Deviation|Mean
831185|NCT01244490|Secondary|Change From Baseline in the WFIRS-P Family Domain Score at Week 10/13 - LOCF|The WFIRS-P Family Domain is the mean of 10 items, ranging from 0 (never/not at all) to 3 (very often/very much). Higher scores indicate greater functional impairment. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.|Baseline and Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years|Full Analysis Set. If more than 30% of items used to derive the score were missing, the corresponding score was considered as missing.||units on a scale||Standard Error|Least Squares Mean
831186|NCT01244490|Secondary|Change From Baseline in the Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Learning and School Domain Scores at Week 10/13 - LOCF|The WFIRS-P Learning in School Domain is the mean of 10 items, ranging from 0 (never/not at all) to 3 (very often/very much). Higher scores indicate greater functional impairment. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.|Baseline and Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years|Full Analysis Set. If more than 30% of items used to derive the score were missing, the corresponding score was considered as missing.||units on a scale||Standard Error|Least Squares Mean
831187|NCT01244490|Secondary|Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.|Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years|Full Analysis Set. Not all subjects in the FAS population had data for this outcome.||percentage of participants|||Number
831188|NCT01244490|Primary|Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Week 10/13 - Last Observation Carried Forward (LOCF)|The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.|Baseline and Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years|Full Analysis Set (FAS) defined as all randomized subjects who took at least 1 dose of investigational product. If more than 20% of the items used for summing a score were missing, the score was set to missing.||units on a scale||Standard Error|Least Squares Mean
831189|NCT01244503|Secondary|Histology -NAS Scoring of Liver Biopsy|"OBT will be compared to histology (including NAS score as described above)and other parameters to develop severity score. Only subjects with biopsy from routine clinical practice will be enrolled.
NAS (Non-alcoholic-steatohepatitis (NASH) Activity Score) scoring system includes the following components: steatosis, which is scaled from 0-3, lobular inflammation, which is scaled from 0-3 and hepatocellular ballooning, which is scaled from 0-2. NAS score greater or equal to 5 indicates NASH. The range of the NAS score is from 0-8."|Up to 6 months|||units on a scale||Standard Deviation|Mean
831190|NCT01244503|Primary|The Peak Value of the PDR (Percentage Dose Recovery of 13C) of OBT (Octanoate Breath Test)|To assess the ability of the OBT to assess disease severity in patients with suspected NAFLD (non alcoholic fatty liver disease) compared to NAS (Non-alcoholic-steatohepatitis (NASH) Activity Score) scoring system, where steatosis is scaled from 0-3, lobular inflammation is scaled from 0-3 and hepatocellular ballooning is scaled from 0-2. NAS score greater or equal to 5 indicates NASH. The higher the PDR peak, the better the liver health and function.PDR units are percent per hour of 13C dose recovery and describes rate of metabolism. The PDR peak is the highest rate of metabolism the liver reaches.The total range of NAS is 0-8.|1 hour|||PDR peak value (%/hour)||Standard Deviation|Mean
831191|NCT01244516|Secondary|Overall Subjective Lens Handling|Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0 to 120. Only galyficlon A and comfilcon A were evaluated.|after 2 weeks of contact lens wear|Analysis is on those subjects who completed the study (n=331) and where assigned to these two arms. Analysis is restricted to these two arms for this outcome as specified per protocol.||CLUE score||Standard Error|Least Squares Mean
831192|NCT01244516|Primary|Corneal Staining|Investigator evaluated corneal staining. Percent of eyes with corneal staining presence or absence is evaluated.|after 2 weeks of contact lens wear|Analysis is on those subjects who completed the study (n=501).||percentage of eyes|Participants||Number
831193|NCT01244516|Primary|Overall Subjective Comfort|Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.|after 2 weeks of contact lens wear|Analysis is on those subjects who completed the study (n=501).||CLUE score||Standard Error|Least Squares Mean
831194|NCT01244529|Secondary|New Lens Power Fit Match to Control Lenses|The lens power fit of test lenses will be compared to control lenses to determine if the power matches. Percent of eyes with exact power fit will be evaluated.|after 15 minutes of contact lens wear|Analysis was on those completed subjects who were enrolled, randomized, and assigned to a study arm.||percentage of eyes|eyes||Number
831195|NCT01244529|Primary|Fit Acceptability|Investigator evaluated lens fit using a six point scale: 5-optimal...3-borderline acceptable...2-unacceptable. Percent of eyes in each category will be evaluated.|after 15 minutes of contact lens wear|Analysis was on those completed subjects who were enrolled, randomized, and assigned to a study arm.||percentage of eyes|eyes||Number
831196|NCT01244529|Primary|Primary Gaze Lens Movement|Investigator evaluated as acceptable (minimal or moderate movement) or unacceptable (insufficient or excessive movement). Percent of eyes in each category will be evaluated.|after 15 minutes of contact lens wear|Analysis was on those completed subjects who were enrolled, randomized, and assigned to a study arm.||percentage of eyes|eyes||Number
831394|NCT01245387|Primary|Number of Participants With PED at Week 18|PED assessed by Investigator at Visit 5, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.|Week 18|FAS; N=number of participants with evaluable data.||Participants|||Number
831198|NCT01244620|Primary|Volume of Distribution at Steady State (Vss)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.|Day 6 (predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post dose)|Not analyzed due to early study termination.||Liter (L)||Standard Deviation|Geometric Mean
831199|NCT01244620|Secondary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Day 6 (predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post dose)|Not analyzed due to early study termination.||hours||Standard Deviation|Mean
831200|NCT01244620|Primary|Apparent Oral Clearance (CL/F)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Day 6 (predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post dose)|Not analyzed due to early study termination.||mL/minute||Standard Deviation|Geometric Mean
831201|NCT01244620|Primary|Area Under the Curve of the 24 Hour Dosing Interval (AUC24)||Day 6 (predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post dose)|Not analyzed due to early study termination.||nanogram hour per milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
831202|NCT01244620|Primary|Maximum Observed Plasma Concentration (Cmax)||Day 6 (predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post dose)|Not analyzed due to early study termination.||micrograms per milliliter (mcg/mL)||Standard Deviation|Geometric Mean
831203|NCT01244620|Primary|Trough Plasma Concentrations (Ctrough)|Minimum or “trough”concentrations|Day 6 (predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post dose)|Not analyzed due to early study termination.||nanograms (ng)/milliliter (mL)||Standard Deviation|Geometric Mean
831204|NCT01244620|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||Day 6 (predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post dose)|Not analyzed due to early study termination.||hours||Full Range|Median
831205|NCT01244633|Secondary|Columbia Scale for Suicide Risk|This test monitors whether the patient has any feelings of committing self-harm. It is mandated by the FDA to include this scale in all clinical trials of new central nervous system drugs.|Every 7 days||||||
831206|NCT01244633|Secondary|Safety Assessments|Patients will be evaluated for any adverse events, and they will have a variety of blood tests to examine if any changes occur.|Every 7 days||||||
831207|NCT01244633|Secondary|Clinician Global Impression – Improvement and Severity Scales (CGI)|This is a measure of how the treating physician perceives the effectiveness of a drug treatment, and it is typically used in these types of clinical trials.|End of trial||||||
831208|NCT01244633|Secondary|Premonitory Urge for Tics Scale (PUTS-1)|This is a measure of the tic behavior that is seen in Tourette's patients, and it is typically used in these types of trials.|Every 7 days||||||
831209|NCT01244633|Secondary|Hamilton Depression Scale|This is a measure of feelings of depression that the patient might have.|Every 7 days||||||
831210|NCT01244633|Secondary|Adult Attention Deficit/Hyperactivity Disorder (ADHD) Self-report Symptom Checklist (ASRS)|This is a standard measure of ADHD severity that is typically used in these types of clinical trials.|Every 7 days||||||
831211|NCT01244633|Primary|Yale Global Tic Severity Score|The Yale Global Tic Severity Score is a composite of subject reported severity of motor (range 0-25) and vocal (range 0-25) tics , as well as an impairment score (range 0-50). The outcome we are using is the Total Tic Severity score which is the sum of the motor and vocal tic severity scores (range 0-50). The higher the score on this scale, the more severe the symptoms. A positive drug effect is associated with a decrease from baseline.|8 weeks|Subjects completing the study||units on a scale||Standard Deviation|Mean
831212|NCT01244711|Primary|Montgomery Asberg Depression Rating Scale (MADRS)|For MDD: The primary efficacy measures will be change from baseline to endpoint in the MADRS and the change in mean daily benzodiazepine dose in diazepam equivalents during the past week. Range is 0 (least severe) to 50 (most severe).|12 weeks|Change in total score on the MADRS from baseline to final visit||units on a scale|||Number
831213|NCT01244724|Secondary|National Hospital Seizure Severity Scale||12 weeks||||||
831214|NCT01244724|Primary|Hamilton Depression Scale|Measure of severity of depression -total score of Hamilton Depression Scale ranges from 0 (no depression) to 60 (worst depression possible)|12 weeks|||units on a scale||Standard Deviation|Mean
831215|NCT01244815|Secondary|Change From Baseline in PQ-LES-Q Overall Score (i.e., Item 15) at Day 21|PQ-LES-Q is a questionnaire to assess quality of life enjoyment and satisfaction in children and adolescents. The participant is asked to rate 15 items reflecting quality of life with respect to the previous week on a scale of 1=very poor to 5=very good. Items 1-14 assess specific areas (e.g., your health, your mood or feelings); Item 15 is a global assessment of overall quality of life. The Item 15 result is defined to be the PQ-LES-Q overall score, and ranged from 1 to 5 with a higher score indicating better quality of life. The reported measure is the change from baseline at Day 21; improvement in quality of life is represented by positive values. This analysis used an LOCF approach; if no Day 21 value was available for a participant, the last available post-baseline on-treatment assessment prior to the Day 21 assessment was used.|Baseline and Day 21|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and at least 1 post-baseline on-treatment value of PQ-LES-Q overall score must be available for a participant.||score on a scale||Standard Deviation|Mean
831223|NCT01244815|Secondary|Change From Baseline in CGI-BP Depression Score at Day 7|The CGI-BP is a clinician-rated instrument for assessing bipolar illness that includes subscales assessing mania and depression. This measure reports one item within the CGI-BP, which is a 7-point scale assessing the severity of the depression component of the participant’s bipolar illness, with ratings from 1=normal, not ill to 7=very severely ill. The reported measure is the change from baseline at Day 7; improvement in symptoms is represented by negative values.|Baseline and Day 7|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 7 value of CGI-BP depression score must be available for a participant.||score on a scale||Standard Deviation|Mean
831216|NCT01244815|Secondary|Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Total Score at Day 21|PQ-LES-Q is a questionnaire to assess quality of life enjoyment and satisfaction in children and adolescents. The participant is asked to rate 15 items reflecting quality of life with respect to the previous week on a scale of 1=very poor to 5=very good. Items 1-14 assess specific areas (e.g., your health, your mood or feelings); Item 15 is a global assessment of overall quality of life. The PQ-LES-Q total score for each participant was calculated as the sum of the rating assigned to each of the first 14 items, and ranged from 14 to 70 with a higher score indicating better quality of life. The reported measure is the change from baseline at Day 21; improvement in quality of life is represented by positive values. This analysis used an LOCF approach; if no Day 21 value was available for a participant, the last available post-baseline on-treatment assessment prior to the Day 21 assessment was used.|Baseline and Day 21|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and at least 1 post-baseline on-treatment value of PQ-LES-Q total score must be available for a participant.||score on a scale||Standard Deviation|Mean
831217|NCT01244815|Secondary|Change From Baseline in Children’s Global Assessment Scale (CGAS) Score at Day 21|CGAS is a 100-point scale measuring psychological, social, and school functioning in children aged 6-17. Minimum scores ranged from 1-10, representing the need for constant supervision (worse result) to maximum scores of 91-100, representing superior functioning (better result). The reported measure is the change from baseline at Day 21; improvement in functioning is represented by positive values. This analysis used an LOCF approach; if no Day 21 value was available for a participant, the last available post-baseline on-treatment assessment prior to the Day 21 assessment was used.|Baseline and Day 21|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and at least 1 post-baseline on-treatment value of CGAS score must be available for a participant.||score on a scale||Standard Deviation|Mean
831218|NCT01244815|Secondary|Change From Baseline in CDRS-R Total Score at Day 21|The CDRS-R is a 17-item clinician-rated instrument for assessing the presence and severity of depressive symptoms in children. Fourteen of the 17 items are rated on a scale of 1-7 and 3 of the items are rated on a scale of 1-5, with higher scores indicating greater severity of symptoms. The CDRS-R total score for each participant is the sum of the ratings for the 17 individual items, and can range from 17-113, with higher scores indicating greater severity of symptoms. The reported measure is the change from baseline at Day 21; improvement in symptoms is represented by negative values.|Baseline and Day 21|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 21 value of CDRS-R total score must be available for a participant.||score on a scale||Standard Deviation|Mean
831219|NCT01244815|Secondary|Change From Baseline in CDRS-R Total Score at Day 14|The CDRS-R is a 17-item clinician-rated instrument for assessing the presence and severity of depressive symptoms in children. Fourteen of the 17 items are rated on a scale of 1-7 and 3 of the items are rated on a scale of 1-5, with higher scores indicating greater severity of symptoms. The CDRS-R total score for each participant is the sum of the ratings for the 17 individual items, and can range from 17-113, with higher scores indicating greater severity of symptoms. The reported measure is the change from baseline at Day 14; improvement in symptoms is represented by negative values.|Baseline and Day 14|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 14 value of CDRS-R total score must be available for a participant.||score on a scale||Standard Deviation|Mean
831220|NCT01244815|Secondary|Change From Baseline in Children's Depression Rating Scale, Revised (CDRS-R) Total Score at Day 7|The CDRS-R is a 17-item clinician-rated instrument for assessing the presence and severity of depressive symptoms in children. Fourteen of the 17 items are rated on a scale of 1-7 and 3 of the items are rated on a scale of 1-5, with higher scores indicating greater severity of symptoms. The CDRS-R total score for each participant is the sum of the ratings for the 17 individual items, and can range from 17-113, with higher scores indicating greater severity of symptoms. The reported measure is the change from baseline at Day 7; improvement in symptoms is represented by negative values.|Baseline and Day 7|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 7 value of CDRS-R total score must be available for a participant.||score on a scale||Standard Deviation|Mean
831221|NCT01244815|Secondary|Change From Baseline in CGI-BP Depression Score at Day 21|The CGI-BP is a clinician-rated instrument for assessing bipolar illness that includes subscales assessing mania and depression. This measure reports one item within the CGI-BP, which is a 7-point scale assessing the severity of the depression component of the participant’s bipolar illness, with ratings from 1=normal, not ill to 7=very severely ill. The reported measure is the change from baseline at Day 21; improvement in symptoms is represented by negative values.|Baseline and Day 21|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 21 value of CGI-BP depression score must be available for a participant.||score on a scale||Standard Deviation|Mean
831222|NCT01244815|Secondary|Change From Baseline in CGI-BP Depression Score at Day 14|The CGI-BP is a clinician-rated instrument for assessing bipolar illness that includes subscales assessing mania and depression. This measure reports one item within the CGI-BP, which is a 7-point scale assessing the severity of the depression component of the participant’s bipolar illness, with ratings from 1=normal, not ill to 7=very severely ill. The reported measure is the change from baseline at Day 14; improvement in symptoms is represented by negative values.|Baseline and Day 14|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 14 value of CGI-BP depression score must be available for a participant.||score on a scale||Standard Deviation|Mean
831616|NCT01247428|Secondary|Device Success|Achievement of a final in-stent residual diameter stenosis of <50% (by QCA), using the assigned device only|8 hours|||percentage of participants||95% Confidence Interval|Number
831224|NCT01244815|Secondary|Change From Baseline in CGI-BP Depression Score at Day 4|The CGI-BP is a clinician-rated instrument for assessing bipolar illness that includes subscales assessing mania and depression. This measure reports one item within the CGI-BP, which is a 7-point scale assessing the severity of the depression component of the participant’s bipolar illness, with ratings from 1=normal, not ill to 7=very severely ill. The reported measure is the change from baseline at Day 4; improvement in symptoms is represented by negative values.|Baseline and Day 4|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 4 value of CGI-BP depression score must be available for a participant.||score on a scale||Standard Deviation|Mean
831225|NCT01244815|Secondary|Change From Baseline in CGI-BP Mania Score at Day 21|The CGI-BP is a clinician-rated instrument for assessing bipolar illness that includes subscales assessing mania and depression. This measure reports one item within the CGI-BP, which is a 7-point scale assessing the severity of the mania component of the participant’s bipolar illness, with ratings from 1=normal, not ill to 7=very severely ill. The reported measure is the change from baseline at Day 21; improvement in symptoms is represented by negative values.|Baseline and Day 21|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 21 value of CGI-BP mania score must be available for a participant.||score on a scale||Standard Deviation|Mean
831226|NCT01244815|Secondary|Change From Baseline in CGI-BP Mania Score at Day 14|The CGI-BP is a clinician-rated instrument for assessing bipolar illness that includes subscales assessing mania and depression. This measure reports one item within the CGI-BP, which is a 7-point scale assessing the severity of the mania component of the participant’s bipolar illness, with ratings from 1=normal, not ill to 7=very severely ill. The reported measure is the change from baseline at Day 14; improvement in symptoms is represented by negative values.|Baseline and Day 14|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 14 value of CGI-BP mania score must be available for a participant.||score on a scale||Standard Deviation|Mean
831227|NCT01244815|Secondary|Change From Baseline in CGI-BP Mania Score at Day 7|The CGI-BP is a clinician-rated instrument for assessing bipolar illness that includes subscales assessing mania and depression. This measure reports one item within the CGI-BP, which is a 7-point scale assessing the severity of the mania component of the participant’s bipolar illness, with ratings from 1=normal, not ill to 7=very severely ill. The reported measure is the change from baseline at Day 7; improvement in symptoms is represented by negative values.|Baseline and Day 7|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 7 value of CGI-BP mania score must be available for a participant.||score on a scale||Standard Deviation|Mean
831228|NCT01244815|Secondary|Change From Baseline in CGI-BP Mania Score at Day 4|The CGI-BP is a clinician-rated instrument for assessing bipolar illness that includes subscales assessing mania and depression. This measure reports one item within the CGI-BP, which is a 7-point scale assessing the severity of the mania component of the participant’s bipolar illness, with ratings from 1=normal, not ill to 7=very severely ill. The reported measure is the change from baseline at Day 4; improvement in symptoms is represented by negative values.|Baseline and Day 4|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 4 value of CGI-BP mania score must be available for a participant.||score on a scale||Standard Deviation|Mean
831229|NCT01244815|Secondary|Total Y-MRS 50% Responders at Days 4, 7, 14 and 21|A total Y-MRS 50% responder was defined as a participant who had a reduction from baseline to the identified study visit of at least 50% in the Y-MRS total score. The Y-MRS is an 11-item clinician-rated instrument for assessing the severity of manic episodes. A severity rating is assigned to each of the 11 items, based on the participant’s subjective report of his or her condition over the previous 48 hours and the clinician’s observations during the interview, with the emphasis on the latter. The Y-MRS total score for each participant is the sum of the ratings for the 11 individual items, and can range from 0-60 with higher scores indicating greater severity of symptoms. This analysis used a Last-Observation-Carried-Forward (LOCF) approach; if at a given visit no Y-MRS total score was available for determining whether a participant was a responder, the last available post-baseline on-treatment assessment prior to that visit was used.|Baseline and Days 4, 7, 14 and 21|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included for a visit, a Y-MRS total score must be available for that visit or a prior post-baseline on-treatment visit||participants|||Number
831230|NCT01244815|Secondary|Change From Baseline in Clinical Global Impression Scale for Use in Bipolar Disorder (CGI-BP) Overall Score at Day 21|Change from baseline in CGI-BP overall score at Day 21 is the Key Secondary Outcome Measure. The CGI-BP is a clinician-rated instrument for assessing bipolar illness that includes subscales assessing mania and depression. This measure reports one item within the CGI-BP, which is a 7-point scale assessing the severity of the participant’s overall bipolar illness, with ratings from 1=normal, not ill to 7=very severely ill. The reported measure is the change from baseline at Day 21; improvement in symptoms is represented by negative values.|Baseline and Day 21|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 21 value of CGI-BP overall score must be available for a participant.||score on a scale||Standard Deviation|Mean
831243|NCT01244893|Secondary|Corneal Staining|Corneal staining type was assessed by Investigator using a slit lamp and graded on a 5-point scale; 0=none, 1=trace, 2=mild, 3=moderate, 4=severe.|6-8 days after lens wear|Population analyzed are those who were enrolled, randomized, and completed the study.||units on a scale|eyes|Standard Deviation|Mean
831395|NCT01245387|Primary|Number of Participants With PED at Week 12|PED assessed by Investigator at Visit 4, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.|Week 12|FAS; N=number of participants with evaluable data.||Participants|||Number
831231|NCT01244815|Primary|Change From Baseline in Y-MRS Total Score at Day 21|The Y-MRS is an 11-item clinician-rated instrument for assessing the severity of manic episodes. A severity rating is assigned to each of the 11 items (Elevated mood, Increased motor activity-energy, Sexual interest, Sleep, Irritability, Speech, Language-thought disorder, Thought content, Disruptive-aggressive behavior, Appearance, Insight), based on the participant’s subjective report of his or her condition over the previous 48 hours and the clinician’s observations during the interview, with the emphasis on the latter. Seven of the 11 items are rated on a scale of 0-4 and 4 of the items are rated on a scale of 0-8, with higher scores indicating greater severity of symptoms. The Y-MRS total score for each participant is the sum of the ratings for the 11 individual items, and can range from 0-60, with higher scores indicating greater severity of symptoms. The reported measure is the change from baseline at Day 21; improvement in symptoms is represented by negative values.|Baseline and Day 21|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy Full Analysis Set [FAS]); also, to be included an on-treatment Day 21 value of Y-MRS total score must be available for a participant.||score on a scale||Standard Deviation|Mean
831232|NCT01244828|Primary|Change From Baseline in PANSS Total Score at Final Assessment|The PANSS is a 30-item clinician-rated instrument for assessing the symptoms of schizophrenia. It consists of 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items). Positive symptoms refer to an excess or distortion of normal mental status (e.g., delusions). Negative symptoms represent a diminution or loss of normal functions (e.g., emotional withdrawal). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score for each participant was calculated as the sum of the rating assigned to each of the 30 PANSS items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at the final assessment for a participant (calculated for a participant as final assessment value minus baseline value); improvement in symptoms is represented by negative values.|Baseline up to Week 52|Participants who received at least one dose of study drug and had a baseline and at least one post-baseline PANSS measurement.||score on a scale||Standard Error|Mean
831233|NCT01244828|Primary|Change From Baseline in PANSS Total Score at Week 52|The PANSS is a 30-item clinician-rated instrument for assessing the symptoms of schizophrenia. It consists of 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items). Positive symptoms refer to an excess or distortion of normal mental status (e.g., delusions). Negative symptoms represent a diminution or loss of normal functions (e.g., emotional withdrawal). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score for each participant was calculated as the sum of the rating assigned to each of the 30 PANSS items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Week 52 (calculated for a participant as Week 52 value minus baseline value); improvement in symptoms is represented by negative values.|Baseline and Week 52|Participants who received at least one dose of study drug and had both a baseline and a Week 52 PANSS measurement.||score on a scale||Standard Error|Mean
831234|NCT01244828|Primary|Change From Baseline in Prolactin at Week 52|Blood samples for determination of prolactin level were obtained at baseline and during the study. For each participant, change from baseline in prolactin at Week 52 was calculated as the Week 52 level minus the baseline level.|Baseline and Week 52|Participants who received at least one dose of study drug and had both a baseline and a Week 52 value of the measure.||µg/L||Standard Deviation|Mean
831235|NCT01244828|Primary|Change From Baseline in Insulin at Week 52|Blood samples for determination of insulin level were obtained at baseline and during the study. For each participant, change from baseline in insulin at Week 52 was calculated as the Week 52 level minus the baseline level.|Baseline and Week 52|Participants who received at least one dose of study drug and had both a baseline and a Week 52 value of the measure.||µIU/mL||Standard Deviation|Mean
831236|NCT01244828|Primary|Change From Baseline in Fasting Glucose at Week 52|Blood samples for determination of fasting glucose level were obtained at baseline and during the study. For each participant, change from baseline in fasting glucose at Week 52 was calculated as the Week 52 level minus the baseline level.|Baseline and Week 52|Participants who received at least one dose of study drug and had both a baseline and a Week 52 value of the measure.||mmol/L||Standard Deviation|Mean
831237|NCT01244828|Primary|Change From Baseline in HbA1c at Week 52|Blood samples for determination of HbA1c were obtained at baseline and during the study. For each participant, change from baseline in HbA1c at Week 52 was calculated as the Week 52 value minus the baseline value.|Baseline and Week 52|Participants who received at least one dose of study drug and had both a baseline and a Week 52 value of the measure.||percent||Standard Deviation|Mean
831238|NCT01244828|Primary|Number of Participants With Extrapyramidal Symptoms|This measure reports the overall number of participants with any of a group of adverse events that were defined to represent extrapyramidal symptoms. The number of participants with each of the individual adverse events within this definition is also presented, for terms that occurred in at least one participant. For this measure, all adverse event terms within the Medical Dictionary for Regulatory Activities (MedDRA) Standardized MedDRA Query (SMQ) for “extrapyramidal syndrome” were treated as extrapyramidal symptoms.|Up to 30 days after last dose of study drug (Up to approximately 56 weeks)|Participants who received at least one dose of study drug.||participants|||Number
831239|NCT01244828|Primary|Change From Baseline in BMI at Week 52|For each participant, change from baseline in BMI was calculated as the Week 52 value minus the baseline value.|Baseline and Week 52|Participants who received at least one dose of study drug and had both a baseline and a Week 52 value of the measure.||kg/m^2||Standard Deviation|Mean
831240|NCT01244828|Primary|Change From Baseline in Weight at Week 52|For each participant, change from baseline in weight was calculated as the Week 52 value minus the baseline value.|Baseline and Week 52|Participants who received at least one dose of study drug and had both a baseline and a Week 52 value of the measure.||kg||Standard Deviation|Mean
831241|NCT01244893|Secondary|Bulbar Redness|Scale of 0 increasing to 4. 0=None, 4=Severe Redness|6-8 days after lens wear|Population analyzed consisted of those who were enrolled, randomized, and completed the study.||units on a scale||Standard Deviation|Mean
831242|NCT01244893|Secondary|Limbal Redness|Limbal redness was assessed by using a 5-point scale: 0=none, 1=trace, 2=mild, 3=moderate, 4=severe.|6-8 days after lens wear|Population analyzed are those who were enrolled, randomized, and completed the study.||units on a scale||Standard Deviation|Mean
831252|NCT01244984|Secondary|Change From Baseline in the Percentage of Rescue-free 24-hour Periods|The time span during which the participants did not have to take any rescue medication (medication intended to relieve symptoms immediately) was considered as a rescue free period. Change from Baseline is calculated as the value at Week 52 minus the value at Baseline.|Baseline up to Week 52|ITT Population||Percentage of rescue free 24-hour period||Standard Deviation|Mean
831253|NCT01244984|Secondary|Change From Baseline in the Percentage of Symptom-free 24-hour Periods During the Study Treatment|Participants who were symptom free for 24-hours were assessed. Change from Baseline is calculated as the value at Week 52 minus the value at Baseline.|Baseline up to Week 52|ITT Population||Percentage of symptom-free days||Standard Deviation|Mean
831254|NCT01244984|Secondary|Change From Baseline in Asthma Symptom Score During the Study Treatment|The Baseline value was calculated as the mean of all available data recorded during the 7 days immediately prior to Visit 2 (treatment assignment visit). Participants entered their asthma symptom score in the patient diary twice daily (morning and evening). Daytime asthma symptom scores: 0-no asthma symptoms, 1-one episode of short-time asthma symptoms, 2-two or more episodes of short-time asthma symptoms, 3-asthma symptoms occurring during most part of daytime without interference with daily life activities, 4-asthma symptoms occurring during most part of daytime with interference with daily life activities, 5-severe asthma symptoms that disable working or daily life activities. Nighttime asthma symptom scores: 0-no asthma symptoms, 1-one awakening due to asthma symptoms, 2-two or more awakenings due to asthma symptoms, 3-asthma symptoms almost prevented the participant from sleeping, 4-severe asthma symptoms completely prevented from sleeping.|Baseline up to Week 52|ITT Population||Scores on a scale||Standard Deviation|Mean
831255|NCT01244984|Secondary|Change From Baseline in Diary Data - Morning (AM) Peak Expiratory Flow (PEF) and Evening (PM) PEF During the Study Treatment|Change from Baseline in AM and PM PEF at 52 weeks of evaluation period during study treatment was recorded in the dairy record card. The Baseline value was calculated as the mean of all available data recorded during the7 days immediately prior to the treatment start date (including Day 1: Day 1 is treatment start date). The PEF is defined as the greatest rate of airflow that can be achieved during forced exhalation beginning with the lungs fully inflated.|Baseline up to Week 52|ITT Population||Litres per Minute (L/min)||Standard Deviation|Mean
831256|NCT01244984|Secondary|Number of Participants With Severe Asthma Exacerbation During the Study Treatment|A severe asthma exacerbation is defined as the deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. Courses of corticosteroids separated by 1 week or more were treated as separate severe exacerbations.|Baseline up to Week 52|ITT Population||Participants|||Number
831257|NCT01244984|Secondary|Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings|A 12-lead ECG was recorded in a supine position after the participant was kept at rest in this position for at least 5 minutes at assessment time points (Baseline[Week -2], Week 12, 24 and Week 52/WD) in the treatment period. Data are presented for clinically significant (CS) as well as not clinically significant (NCS) abnormal (Abn) findings. Any abnormal ECG, including those that worsen from Baseline, and determined clinically significant by the assessment of the investigator were recorded as CS.|Week 12, Week 24, and Week 52/WD|"ITT Population. . Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X."||Participants|||Number
831258|NCT01244984|Secondary|Change From Baseline in Heart Rate (HR)|Heart rate was measured in a sitting position after a participant was kept at rest for at least 5 minutes at Baseline (Week 0), Weeks 12, 24 and Week 52/WD. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Week 0), Week 12, Week 24, and Week 52/WD|ITT Population. Only those participants with post-Baseline data available at the indicated time points were analyzed.||Beats/Minute||Standard Deviation|Mean
831259|NCT01244984|Secondary|Change From Baseline in Blood Pressure|Blood pressure measurement included systolic blood pressure (SBP) and diastolic blood pressure (DBP) at Baseline (Week 0), Weeks 12, 24 and Week 52/WD. Blood pressure was measured in a sitting position after a participant was kept at rest for at least 5 minutes. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Week 0), Week 12, Week 24, and Week 52/WD|ITT Population. Only those participants with post-Baseline data available at the indicated time points were analyzed.||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
831260|NCT01244984|Secondary|Change From Baseline in the 24-hour Urinary Cortisol Excretion|Urine samples were collected for measurement of urinary cortisol excretion at the following scheduled time points: Baseline (Week 0), Week 24, and Week 52/WD. The 24-hour urinary cortisol excretion was calculated by multiplying the total volume of urine by the concentration of urinary cortisol. Cortisol is a hormone released from the adrenal gland that helps in fat, protein, and carbohydrate metabolism. Change from Baseline was calculated as the value at post-Baseline time point minus the value at Baseline.|Baseline (Week 0), Week 24, and Week 52/WD|Urine cortisol (UC) Population: all participants in the ITT Population from whom urine specimens were collected and who were considered not to have any confounding factors that might affect the analysis of the results of the specimens. Only those participants with post-Baseline data available at the indicated time points were analyzed.||Nanomoles (nmol)/24 hours||Geometric Coefficient of Variation|Geometric Mean
831261|NCT01244984|Secondary|Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD|Urinalysis parameters included: Urine Occult Blood (UOB), Urine Glucose (UG), Urine Ketones (UK), Urine Protein (UP), and Urine Leukocyte Esterase test for detecting White Blood Cell (UWBC). The dipstick was a strip used to detect the presence or absence of these parameters in the urine sample. The dipstick test gives results in a semi-quantitative manner, and results can be read as negative (Neg), Trace (TRA), 1+, 2+, and 3+, indicating proportional concentrations in the urine sample. Data are reported as the number of participants who had neg, trace, 1+, 2+, and 3+ levels at Baseline (Week -2) and Week 52/WD.|Baseline (Week -2), Week 12, Week 24, and Week 52/WD|"ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X."||Participants|||Number
831262|NCT01244984|Secondary|Laboratory Parameter of Urine Specific Gravity (USG) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD|Urine samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD.|Baseline (Week -2), Week 12, Week 24, and Week 52/WD|"ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X."||ratio of urine density to water density||Standard Deviation|Mean
831263|NCT01244984|Secondary|Laboratory Parameter of Urine Potential of Hydrogen (pH) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD|Urine samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD.|Baseline (Week -2), Week 12, Week 24, and Week 52/WD|"ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X."||pH||Standard Deviation|Mean
831264|NCT01244984|Secondary|Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD|Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD.|Baseline (Week -2), Week 12, Week 24, and Week 52/WD|"ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X."||Millimoles per Liter (mmol/L)||Standard Deviation|Mean
831265|NCT01244984|Secondary|Laboratory Parameter of Bilirubin (Direct [BD], Indirect [BI], Total [BT], Creatinine, and Uric Acid at Baseline (Week -2), Week 12, Week 24, and Week 52/WD|Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD.|Baseline (Week -2), Week 12, Week 24, and Week 52/WD|"ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X."||Micromoles per Liter (µmol/L)||Standard Deviation|Mean
831266|NCT01244984|Secondary|Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD|Blood samples were collected for measurement at the following scheduled time points: Baseline (BL) (Week -2), Week 12, Week 24 and Week 52/WD.|Baseline (Week -2), Week 12, Week 24, and Week 52/WD|"ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X."||International unit per liter (IU/L)||Standard Deviation|Mean
831267|NCT01244984|Secondary|Laboratory Parameter of Albumin and Total Protein (TP) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD|Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD.|Baseline (Week -2), Week 12, Week 24, and Week 52/WD|"ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X."||g/L||Standard Deviation|Mean
831268|NCT01244984|Secondary|Laboratory Parameter of Red Blood Cell Count at Baseline (Week -2), Week 12, Week 24, and Week 52/WD|Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD.|Baseline (Week -2), Week 12, Week 24, and Week 52/WD|"ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X."||10^12 per liter (Ti/L)||Standard Deviation|Mean
831269|NCT01244984|Secondary|Laboratory Parameter of Hematocrit at Baseline (Week -2), Week 12, Week 24, and Week 52/WD|Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD.|Baseline (Week -2), Week 12, Week 24, and Week 52/WD|"ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X."||Proportions of I||Standard Deviation|Mean
831270|NCT01244984|Secondary|Laboratory Parameter of Hemoglobin at Baseline (Week -2), Week 12,Week 24, and Week 52/WD|Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD.|Baseline (Week -2), Week 12, Week 24, and Week 52/WD|"ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X."||Grams per liter (g/L)||Standard Deviation|Mean
831271|NCT01244984|Secondary|Laboratory Parameters of Eosinophils, Platelet Count, White Blood Cell (WBC), and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD|Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD.|Baseline (Week -2), Week 12, Week 24, and Week 52/WD|"ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X."||10^9 per liter (Gi/L)||Standard Deviation|Mean
831282|NCT01245049|Secondary|Anti-Polio Type 1, 2 and 3 Antibody Titers|Antibody titers were presented as geometric mean titers (GMTs).|At Month 0, before the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||Titers||95% Confidence Interval|Geometric Mean
831272|NCT01244984|Secondary|Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD|Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD.|Baseline (Week -2), Week 12, Week 24, and Week 52/WD|"ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X."||Percentage||Standard Deviation|Mean
831273|NCT01244984|Primary|Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs (occurring at a frequency threshold >=5%) and SAE.|From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD])|Intent-to-Treat (ITT) Population: all participants who had been randomized to and received at least one dose of randomized medication in the treatment period||Participants|||Number
831274|NCT01245049|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (From Day 0 to Month 1)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and for whom data were available.||Participants|||Count of Participants
831275|NCT01245049|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Days 0-30) follow-up period after booster vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and for whom data were available.||Participants|||Count of Participants
831276|NCT01245049|Secondary|Number of Subjects With Any Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade.|During the 4-day (Days 0-3) follow-up period after booster vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented, who had their symptoms sheet filled in and for whom data were available.||Participants|||Count of Participants
831277|NCT01245049|Secondary|Number of Subjects With Any Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.|During the 4-day (Days 0–3) follow-up period after booster vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented, who had their symptoms sheet filled in and for whom data were available.||Participants|||Count of Participants
831278|NCT01245049|Secondary|Number of Seroconverted Subjects for Anti-mumps|Seroconversion for anti-mumps was defined as the appearance of antibodies after vaccination in subjects who were initially seronegative [with antibody concentrations ≥ 231 units per millilitre (U/mL)].|Before (Month 0) and one month after (Month 1) the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||Participants|||Count of Participants
831279|NCT01245049|Secondary|Number of Seroconverted Subjects for Anti-measles|Seroconversion for anti-measles was defined as the appearance of antibodies after vaccination in subjects who were initially seronegative [with antibody concentrations ≥ 150 milli-international units per millilitre (mIU/mL)].|Before (Month 0) and one month after (Month 1) the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||Participants|||Count of Participants
831280|NCT01245049|Secondary|Number of Subjects With Booster Response for Polio Type 1, 2 and 3 Antigens|Booster response defined as: For initially seronegative subjects, antibody titers at least four times the cut-off (post-vaccination titer ≥ 32); For initially seropositive subjects, an increase in antibody titers of at least four times the Pre booster vaccination titer.|At Month 1, one month after the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||Participants|||Count of Participants
831281|NCT01245049|Secondary|Number of Subjects With a Booster Response to PT, FHA and PRN Antigens|Booster response was defined as: For initially seronegative subjects (pre-vaccination concentration < 5 EL.U/mL), antibody concentrations at least four times the assay cut-off (post vaccination concentration ≥ 20 EL.U/mL). For initially seropositive subjects (with pre-vaccination concentration ≥ 5 EL.U/mL and < 20 EL.U/mL), an increase in antibody concentrations of at least four times the Pre booster vaccination concentration. For initially seropositive subjects (with pre-vaccination concentration ≥ 20 EL.U/mL), an increase in antibody concentrations of at least two times the Pre booster vaccination concentration.|At Month 1, one month after the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||Participants|||Count of Participants
831283|NCT01245049|Secondary|Anti-rubella Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.|Before (Month 0) and one month after (Month 1) the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||IU/mL||95% Confidence Interval|Geometric Mean
831284|NCT01245049|Secondary|Anti-measles Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.|Before (Month 0) and one month after (Month 1) the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||mIU/mL||95% Confidence Interval|Geometric Mean
831285|NCT01245049|Secondary|Anti-mumps Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in U/mL.|Before (Month 0) and one month after (Month 1) the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||U/mL||95% Confidence Interval|Geometric Mean
831286|NCT01245049|Secondary|Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.|At Month 0, before the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
831287|NCT01245049|Secondary|Anti-D and Anti-T Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.|Before (Month 0) and one month after (Month 1) the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||IU/mL||95% Confidence Interval|Geometric Mean
831288|NCT01245049|Secondary|Number of Seropositive Subjects for Anti-rubella Antibody|A seropositive subject was defined as a subject with anti-rubella antibody titers ≥ 4 IU/mL.|Before (Month 0) and one month after (Month 1) the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||Participants|||Count of Participants
831289|NCT01245049|Secondary|Number of Seropositive Subjects for Anti-mumps Antibody|A seropositive subject was defined as a subject with anti-mumps antibody titers ≥ 231 U/mL.|Before (Month 0) and one month after (Month 1) the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||Participants|||Count of Participants
831290|NCT01245049|Secondary|Number of Seropositive Subjects for Anti-measles Antibody|A seropositive subject was defined as a subject with anti-measles antibody titers ≥ 150 mIU/mL.|Before (Month 0) and one month after (Month 1) the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||Participants|||Count of Participants
831291|NCT01245049|Secondary|Number of Seroprotected Subjects Against Polio Type 1, 2 and 3|A seroprotected subject was defined as a subject with anti-polio type 1, 2 and 3 antibody titres ≥ the value of 8.|Before (Month 0) and one month after (Month 1) the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||Participants|||Count of Participants
831292|NCT01245049|Secondary|Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN|A seropositive subject for anti-PT, anti-FHA and anti-PRN was a subject whose antibody concentration was ≥ 5 EL.U/mL.|Before (Month 0) and one month after (Month 1) the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||Participants|||Count of Participants
831293|NCT01245049|Secondary|Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T)|A seroprotected subject was defined a subject with anti-D and anti-T antibody concentrations ≥ 0.1 international units per millilitre (IU/mL).|Before (Month 0) and one month after (Month 1) the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||Participants|||Count of Participants
831294|NCT01245049|Primary|Anti-Polio Virus Type 1, 2 and 3 Antibody Titers|Antibody titers were presented as geometric mean titers (GMTs).|At Month 1, one month after the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||Titers||95% Confidence Interval|Geometric Mean
831295|NCT01245049|Primary|Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).|At Month 1, one month after the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
831296|NCT01245049|Primary|Number of Subjects With a Booster Response to Diphtheria (D) and Tetanus (T) Antigens|Booster response was defined as: For initially seronegative subjects [i.e. pre-vaccination concentration below (<) cut-off value of 0.1 international units per milliliter (IU/mL)] antibody concentrations at least four times the assay cut-off [post vaccination concentration greater than or equal to (≥) 0.4 IU/ml]. For initially seropositive subjects (pre-vaccination concentration ≥ 0.1 IU/ml), an increase in antibody concentrations of at least four times the Pre booster vaccination concentration.|At Month 1, one month after the booster vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||Participants|||Count of Participants
831317|NCT01245140|Secondary|Change From Baseline in Heart Rate at EOT (Week 24)|HR is defined as the rate at which the heart beats. Change from Baseline is defined as the value at EOT minus the Baseline value.|Baseline and EOT (Week 24)|Safety Population. Only those participants available at the specified time points were analyzed.||bpm||Standard Deviation|Mean
831318|NCT01245140|Secondary|Change From Baseline in SBP and DBP at EOT (Week 24)|Change from Baseline is defined as the value at EOT minus the Baseline value.|Baseline and EOT (Week 24)|Safety Population. Only those participants available at the specified time points were analyzed.||mmHg||Standard Deviation|Mean
831312|NCT01245101|Secondary|Markers of Immune Activation|Flow cytometry will be performed in whole blood for analysis of markers of immune activation by standard methodology using a LSR-II flow cytometer. Percentage and absolute counts of CD8+CD38+ cells will be determined as the main outcome measure.|16 weeks|11 of 12 subjects meeting the per protocol definition were analyzed for the Raltegravir then Observation arm. Poor enrollment led to early termination of study before second arm was activated.||Percentage of activated CD8+CD38+ cells||Standard Deviation|Mean
831313|NCT01245101|Primary|Episomal HIV cDNA Formation|These are linear viral cDNAs that are subsequently circularized by the DNA repair apparatus of the host cell to form episomes. They are markers of ongoing viral replication.|16 weeks|11 of 12 subjects meeting the per protocol definition were analyzed for the Raltegravir then Observation arm. Poor enrollment led to early termination of study before second arm was activated.||copies/million||Standard Deviation|Mean
831314|NCT01245140|Secondary|Number of Participants With a Negative Serum Pregnancy Test at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29)|Serum pregnancy tests were performed at each visit for females of childbearing potential.|Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); safety follow-up (Week 29)|Safety population. Only female participants were analysed for serum pregnancy test.||Participants|||Number
831315|NCT01245140|Secondary|Number of Participants With Normal/Abnormal Physical Status at Baseline With a Worst Post-Baseline Finding of Normal/Abnormal|A physical examination for each participant was performed at Baseline and at EOT (Week 24). The primary investigator classified physical status as either normal or abnormal.|Baseline and EOT (Week 24)|Safety Population||Participants|||Number
831316|NCT01245140|Secondary|Change From Baseline in Weight at EOT (Week 24)|Change from Baseline is defined as the value at EOT minus the value at Baseline.|Baseline and EOT (Week 24)|Safety Population. Only those participants available at the specified time points were analyzed.||kg||Standard Deviation|Mean
831319|NCT01245140|Secondary|Mean Body Weight at Screening, Baseline ,and EOT (Week 24)|Body weight was measured at Screening, Baseline, and EOT.|Screening, Baseline, and EOT (Week 24)|Safety Population. Only participants available at the specified time points were analyzed (n=X, X).||Kilograms (kg)||Standard Deviation|Mean
831322|NCT01245140|Secondary|Absolute Change From Baseline in the CSSRS Score at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29)|The assessment of suicidality was conducted using the CSSRS, a brief questionnaire designed to assess severity and change in suicidality using a semi-structured interview to probe participant responses. The suicidal ideation intensity total score was the sum of suicidal ideation severity rating scores for frequency, duration, controllability, deterrents, and reasons for ideation. For each item, each participant got an intensity score from 0(none) to 5(worst). Therefore, the suicidal ideation intensity total score range from 0 to 25, with a score of 0 given for no suicidal ideation. CSSRS scores were reported at Baseline; Week 4, 8, 12, 16, 20; EOT (Week 24); and safety follow-up (Week 29). Change from Baseline is defined as the value at the post-Baseline visit minus the Baseline value.|Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and safety follow-up (Week 29)|Safety Population. Only participants available at the specified time points were analyzed (n=X, X).||Scores on a scale||Standard Deviation|Mean
831323|NCT01245140|Secondary|Mean Columbia Suicide Severity Rating Scale (CSSRS) Scores at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29)|The assessment of suicidality was conducted using the CSSRS, a brief questionnaire designed to assess severity and change in suicidality using a semi-structured interview to probe participant responses. The suicidal ideation intensity total score was the sum of suicidal ideation severity rating scores for frequency, duration, controllability, deterrents, and reasons for ideation. For each item, each participant got an intensity score from 0(none) to 5(worst). Therefore, the suicidal ideation intensity total score range from 0 to 25, with a score of 0 given for no suicidal ideation. CSSRS scores were reported at Screening; Baseline; Week 4, 8, 12, 16, 20; EOT (Week 24);and safety follow-up (Week 29).|Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24), and safety follow-up (Week 29)|Safety Population. Only participants available at the specified time points were analyzed (n=X, X).||Scores on a scale||Standard Deviation|Mean
831324|NCT01245140|Secondary|Absolute Change From Baseline (BL) in CES-D Scores at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29)|The CES-D scale is a short, self-report scale designed to measure depressive symptomatology in the general population. The CES-D consists of 20 questions. Participants were instructed to circle the number for each statement that best described how often they felt or behaved a particular way during the past week. The score was the sum of the weights of the 20 items. Responses range from 0 to 3 for each item (0=rarely or none of the time, 1=some or little of the time, 2=moderately or much of the time, 3=most or almost all the time). The CES-D score ranges from 0 to 60, with higher scores indicating greater depression. Participants with a CES-D score of >=20 were re-evaluated within 2 weeks. If a CES-D score of >=20 was confirmed on the second occasion, and if the score represents an increase over BL of 4 points or more, study treatment was interrupted and the participants were referred for psychiatric evaluation. Change from BL is defined as the post-BL value minus the BL value.|Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and safety follow-up (Week 29)|Safety Population. Only participants available at the specified time points were analyzed (n=X, X).||Scores on a scale||Standard Deviation|Mean
831325|NCT01245140|Secondary|Mean Center for Epidemiological Studies Depression Scale (CES-D) Scores at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29)|The CES-D scale is a short, self-report scale designed to measure depressive symptomatology in the general population. The CES-D consists of 20 questions. Participants were instructed to circle the number for each statement that best described how often they felt or behaved a particular way during the past week. The score was the sum of the weights of the 20 items. Responses range from 0 to 3 for each item (0=rarely or none of the time, 1=some or little of the time, 2=moderately or much of the time, 3=most or almost all the time). The CES-D score ranges from 0 to 60, with higher scores indicating greater depression. Participants with a CES-D score of 20 or higher were re-evaluated within 2 weeks. If a CES-D score of 20 or higher was confirmed on the second occasion, and if the score represents an increase over Baseline of 4 points or more, study treatment was interrupted and the participants were referred for psychiatric evaluation.|Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and safety follow-up (Week 29)|Safety Population. Only participants available at the specified time points were analyzed (n=X, X).||Scores on a scale||Standard Deviation|Mean
831326|NCT01245140|Secondary|Number of Participants With the Indicated Shift in the Indicated Laboratory Values From Baseline (BL) to EOT (Week 24)|Laboratory parameters included triglycerides, total cholesterol, HDL cholesterol, LDL cholesterol, LDL/HDL ratio, alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, and amylase and lipase. The central laboratory classified a finding as either abnormal or normal.|From Baseline until EOT (Week 24)|Safety Population||Participants|||Number
831327|NCT01245140|Secondary|Absolute Change From Baseline in Fasted LDL/HDL Ratio at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29)|Change from Baseline is defined as the value at the safety follow up visit minus baseline value.|Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24) and safety follow-up (Week 29)|Safety Population. Only participants available at the specified time points were analyzed (n=X, X).||Ratio||Standard Deviation|Mean
831328|NCT01245140|Secondary|Absolute Change From Baseline in Fasted Lipid Laboratory Test Values at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29)|Fasted lipid laboratory parameters included triglycerides, total cholesterol, high-density lipoprotein (HDL) cholesterol, and low-density lipoprotein (LDL) cholesterol. Change from Baseline is defined as the value at the post-Baseline visit minus the Baseline value.|Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and safety follow-up (Week 29)|Safety Population. Only participants available at the specified time points were analyzed (n=X, X).||Millimoles per liter (mmol/L)||Standard Deviation|Mean
831329|NCT01245140|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) and an AE/SAE Related to Study Treatment|An AE was any adverse change from the participant’s Baseline (pre-treatment) clinical condition, including intercurrent illness, which occurred during the course of a clinical study after written informed consent had been given, whether considered related to treatment or not. The relationship of AEs to the study treatment was assessed as unrelated, remotely related, possibly related, and probably related. For an AE to be considered serious, it fell into one or more of the following categories: results in death, is life threatening, results in persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, and is a congenital abnormality or birth defect.|From Baseline until safety follow up (Week 29)|Safety Population: all randomized participants who received at least one dose of study medication||Participants|||Number
831330|NCT01245140|Secondary|Absolute Change From Baseline in NAPSI Score for Nail Bed Psoriasis and Nail Matrix Psoriasis at Week 12, and EOT (Week 24)|The severity of nail lesions was assessed for all participants with psoriatic nail involvement by obtaining the NAPSI score. Scores were taken for fingernails only. No scores were taken for participants with traumatic or fungal changes in nails. The nail was divided into four quadrants, each of which was rated with a 0 or 1, based on the absence (0) or presence (1) of pathological signs resulting from involvement of both the nail matrix and the nail bed. Each nail was given a score for nail bed psoriasis (0-4) and nail matrix psoriasis (0-4) depending on the presence of nail psoriasis in that quadrant. Possible scores for matrix and nail bed psoriasis: 0=none, 1=present in 1/4 nail, 2=present in 2/4 nail, 3=present in 3/4 nail, 4=present in 4/4 nail. NAPSI score for nail matrix (0-4) and nail bed (0-4) were reported at Baseline, Week 12, and at the EOT visit (Week 24). Change from Baseline is defined as the value at the post-Baseline visit minus the Baseline value.|Baseline, Week 12, and EOT (Week 24)|Full Analysis Set. Only participants available at the specified time points were analyzed (n=X, X).||Scores on a scale||Standard Deviation|Mean
831331|NCT01245140|Secondary|Mean Nail Psoriasis Severity Index (NAPSI) Score for Nail Bed Psoriasis and Nail Matrix Psoriasis at Baseline, Week 12, and EOT (Week 24)|The severity of nail lesions was assessed for all participants with psoriatic nail involvement by obtaining the NAPSI score. Scores were taken for fingernails only. No scores were taken for participants with traumatic or fungal changes in nails. The nail was divided into four quadrants, each of which was rated with a 0 or 1, based on the absence (0) or presence (1) of pathological signs resulting from involvement of both the nail matrix and the nail bed. Each nail was given a score for nail bed psoriasis (0-4) and nail matrix psoriasis (0-4) depending on the presence of nail psoriasis in that quadrant. Possible scores for matrix and nail bed psoriasis: 0=none, 1=present in 1/4 nail, 2=present in 2/4 nail, 3=present in 3/4 nail, 4=present in 4/4 nail. NAPSI score for nail matrix (0-4) and nail bed (0-4) were reported at Baseline, Week 12, and at the EOT visit (Week 24).|Baseline, Week 12, and EOT (Week 24)|Full Analysis Set. Only participants available at the specified time points were analyzed (n=X, X).||Scores on a scale||Standard Deviation|Mean
831332|NCT01245140|Secondary|Number of Participants With mPASI 50 Response and mPASI 75 Response|Psoriatic plaques were graded based on three criteria: redness (R), thickness (T), and scaliness (S). Severity was rated for each criterion on a 5-point scale (0=no involvement, up to 4=severe involvement). The fraction of the total surface area affected on the head, upper extremities, trunk, and lower extremities was graded on a 7-point scale (0=no involvement, up to 6=greater than 90% involvement). The four body regions were weighted to reflect their respective proportion of body surface area, and the composite mPASI score for all body regions was calculated. mPASI 50 response and mPASI 75 response is defined as a 50% and 75% decrease, respectively, in the mPASI score from Baseline.|From Baseline until EOT (Week 24)|Full analysis set. Participants with lesions in areas of the body other than the hands and feet were assessed.||Participants|||Number
831333|NCT01245140|Secondary|Change From Baseline in the mPASI Score at EOT (Week 24) or at the Last Assessment|Psoriatic plaques were graded based on three criteria: redness (R), thickness (T), and scaliness (S). Severity was rated for each criterion on a 5-point scale (0=no involvement, up to 4=severe involvement). Fraction of the total surface area affected on the head, upper extremities, trunk, and lower extremities was graded on a 7-point scale (0=no involvement, up to 6=greater than 90% involvement). The four body regions were weighted to reflect their respective proportion of body surface area, and the composite mPASI score for all body regions was calculated based on redness, thickness, and scaliness scores of plaques (0-4 each) for head, upper extremities, trunk, lower extremities and area of psoriatic involvement score (0-6). Lowest possible mPASI score was 0 and highest up to 72; Higher score values represents greater severity of psoriasis. mPASI scores were continuous, with 0.1 increments within these values. Change from Baseline is defined as the value at EOT minus baseline value.|Baseline and EOT (Week 24) or the last assessment|Full Analysis Set||Scores on a scale||Standard Deviation|Mean
831334|NCT01245140|Secondary|Mean Modified Psoriasis Area Severity Index (mPASI) Score at Baseline; Weeks 4, 8, 12, 16, and 20; and EOT (Week 24)|Psoriatic plaques were graded based on three criteria: redness (R), thickness (T), and scaliness (S). Severity was rated for each criterion on a 5-point scale (0=no involvement, up to 4=severe involvement). Fraction of the total surface area affected on the head, upper extremities, trunk, and lower extremities was graded on a 7-point scale (0=no involvement, up to 6=greater than 90% involvement). The four body regions were weighted to reflect their respective proportion of body surface area, and the composite mPASI score for all body regions was calculated based on the redness, thickness, and scaliness scores of plaques (0-4 each) for the head, upper extremities, trunk, and lower extremities and the area of psoriatic involvement score (0-6). The lowest possible mPASI score was zero and highest up to 72; Higher score values represents greater severity of psoriasis. mPASI scores were continuous, with 0.1 increments within these values.|Baseline; Weeks 4, 8, 12, 16, and 20; and EOT (Week 24)|Full Analysis Set. Only participants available at the specified time points were analyzed (n=X, X).||Scores on a scale||Standard Deviation|Mean
831335|NCT01245140|Secondary|Absolute Change From Baseline (BL) in Total Pustule Count at Weeks 4, 8, 12, 16, and 20 and at EOT (Week 24)|The overall number of fresh and older pustules on the left and right palms and soles was assessed at Baseline, at each visit during the treatment period (Weeks 4, 8, 12, 16, and 20), and at the End of Treatment visit. The total pustule count was calculated as the sum of the pustule count for the left/right palm and left/right sole. Change from Baseline is defined as the value at the post-Baseline visit minus the Baseline value.|Baseline; Weeks 4, 8, 12, 16, and 20; and EOT (Week 24)|Full Analysis Set. Only participants available at the specified time points were analyzed (n=X, X).||Pustule count||Standard Deviation|Mean
831336|NCT01245140|Secondary|Total Pustule Count at Baseline; Weeks 4, 8, 12, 16, and 20; and at EOT (Week 24)|The overall number of fresh and older pustules on the left and right palms and soles was assessed at Baseline, at each visit during the treatment period (Weeks 4, 8, 12, 16, and 20), and at the EOT visit. The total pustule count was calculated as the sum of the pustule count for the left/right palm and left/right sole.|Baseline; Weeks 4, 8, 12, 16, and 20; and EOT (Week 24)|Full Analysis Set. Only participants available at the specified time points were analyzed (n=X, X).||Pustule count||Standard Deviation|Mean
831349|NCT01245283|Secondary|Chair Rise Time and Stair Climb Time; Change From Baseline at 4 Months|Functional abilities related to moving body weight will be captured using two standard tests, the chair rise time and stair climb time. Subjects will complete the tests at the time intervals indicated to document any change in their functional abilities.|Baseline, 4 Months|||Seconds||Standard Deviation|Mean
831337|NCT01245140|Primary|Number of Participants With PPPASI 50 Response and PPPASI 75 Response|The investigator evaluated the PPPASI score on a 5-point scale. The parameters of erythema, total number of pustules, and desquamation were scored for the right/left palm and the right/left sole. After correcting the scores for area (based on a 7-point scale) and the site involved (palm or sole), the PPPASI score per palm/sole was produced. The final PPPASI score was calculated as the sum of the PPPASI score for the right sole + the PPPASI score for the left sole + the PPPASI score for the right palm + the PPPASI score for the left palm and ranges from 0 (no palmo-plantar pustulosis psoriasis [PPP]) to 72 (most severe PPP). Change from Baseline is defined as value at the EOT minus the Baseline value. PPPASI 50 response and PPPASI 75 response are defined as a 50% and 75% decrease, respectively, in the PPPASI score from Baseline.|From Baseline until EOT (Week 24) or the last assessment|Full Analysis Set||Participants|||Number
831338|NCT01245140|Primary|Change From Baseline in the Palmo-plantar Pustulosis Psoriasis Area and Severity Index (PPPASI) Score at the End of Treatment (EOT) (Week 24) or at the Last Assessment|The investigator evaluated the PPPASI score on a 5-point scale. The parameters of erythema, total number of pustules, and desquamation were scored for the right/left palm and the right/left sole. After correcting the scores for area (based on a 7-point scale) and the site involved (palm or sole), the PPPASI score per palm/sole was produced. The final PPPASI score was calculated as the sum of the PPPASI score for the right sole + the PPPASI score for the left sole + the PPPASI score for the right palm + the PPPASI score for the left palm and ranges from 0 (no palmo-plantar pustulosis psoriasis [PPP]) to 72 (most severe PPP). Change from Baseline is defined as value at the EOT minus the Baseline value.|Baseline and EOT (Week 24) or the last assessment|Full Analysis Set : treated participants with >=1 efficacy result after receiving study medication.||Scores on a scale||Standard Deviation|Mean
831339|NCT01245270|Secondary|Bioavailability in Urine|To measure the amount of anthocyanins and phenolic-derived metabolites by liquid chromatography mass spectrometry (LC-MS) being absorbed from the gut and excreted following the single intervention.|Urine will also be collected (if possible) 0, 1, 3 and 5 hours, with all urine collected within the 24 hour time period post intervention||08/2017||||
831340|NCT01245270|Secondary|Bioavailability in Plasma|To measure the amount of anthocyanins and phenolic-derived metabolites by liquid chromatography mass spectrometry (LC-MS) being absorbed from the gut and excreted following the single intervention.|Plasma will also be collected -15,-10, -5, 15, 30, 45, 60, 90, 120, 150, and 300 minutes and 24 hours post intervention||08/2017||||
831341|NCT01245270|Primary|Plasma Insulin iAUC (Incremental Area Under the Curve; ng/ml*Min)|"Volunteers were fasted (10–12 h) overnight before the OGTT. Venous blood samples were taken through an indwelling cannula inserted into a forearm vein at –15, –10 and –5 (fasted) and at 15, 30, 45, 60, 90, 120, 150 and 300 min after consuming 75 g of Polycal liquid (carbohydrate, 61•9%; polysaccharide, 49•2
%; sugars, 12•2%; glucose, 0•6%; maltose, 11•6%; http://www. nutricia.co.uk). Polycal was selected as the main carbohydrate as it is in the form of polysaccharides and this is closer to normal dietary consumption than glucose only.The volunteers consumed the appropriate capsule (0 min), glucose load and a further sample of water (70 ml) within 3 min.
For those volunteers taking the control capsule, additional sugar (fructose and dextrose/glucose) was added double-blinded to the water to match the free sugar content of the Mirtoselect® capsules. Movement during the 300 min OGTT was kept to a minimum."|Plasma was collected at -15, -10 and -5 (fasted) and at 15, 30, 45, 60, 90, 120, 150 and 300 min after the capsule|||insulin iAUC (ng/ml*min)||Standard Error|Mean
831342|NCT01245270|Primary|Plasma Glucose iAUC (Incremental Area Under the Curve; mM*Min)|"Volunteers were fasted (10–12 h) overnight before the OGTT. Venous blood samples were taken through an indwelling cannula inserted into a forearm vein at –15, –10 and –5 (fasted) and at 15, 30, 45, 60, 90, 120, 150 and 300 min after consuming 75 g of Polycal liquid (carbohydrate, 61·9%; polysaccharide, 49·2
%; sugars, 12·2%; glucose, 0·6%; maltose, 11·6%; http://www. nutricia.co.uk). Polycal was selected as the main carbohydrate as it is in the form of polysaccharides and this is closer to normal dietary consumption than glucose only.The volunteers consumed the appropriate capsule (0 min), glucose load and a further sample of water (70 ml) within 3 min.
For those volunteers taking the control capsule, additional sugar (fructose and dextrose/glucose) was added double-blinded to the water to match the free sugar content of the Mirtoselect® capsules. Movement during the 300 min OGTT was kept to a minimum."|Plasma was collected at -15, -10 and -5 (fasted) and at 15, 30, 45, 60, 90, 120, 150 and 300 min post capsule|||glucose iAUC (mM*min)||Standard Error|Mean
831343|NCT01245283|Secondary|Seated Row Test; Change From Baseline at 4 Months|Each participant will perform a one repetition maximum. Participants will do a seated row test which is pulling on a cable to lift weight from a seated row position. This resistence is measured in pounds.|Baseline, 4 Months|||foot x pounds||Standard Deviation|Mean
831344|NCT01245283|Secondary|Shoulder Press Test; Change From Baseline at 4 Months|Each participant will perform a one repetition maximum. Participants will perform the shoulder press which is a weight training exercise, typically performed while standing, in which a weight is pressed straight upwards from the shoulders until the arms are locked out overhead. This resistence is measured in pounds.|Baseline, 4 Months|||foot x pounds||Standard Deviation|Mean
831345|NCT01245283|Secondary|Chest Press; Change From Baseline at 4 Months|Each participant will perform a one repetition maximum. Participants will perform a chest press which is an upper body strength training exercise that consists of pressing a weight upwards from a supine position. This resistence is measured in pounds.|Baseline, 4 Months|||foot x pounds||Standard Deviation|Mean
831346|NCT01245283|Secondary|Leg Curl Test; Change From Baseline at 4 Months|Each participant will perform a one repetition maximum. Participant will perform a leg curl which is an isolation exercise that targets the hamstring muscles. The exercise involves flexing the lower leg against resistance towards the buttocks. This resistence is measured in pounds.|Baseline, 4 Months|||foot x pounds||Standard Deviation|Mean
831347|NCT01245283|Secondary|Leg Extensions Test; Change From Baseline at 4 Months|Each participant perform a one repetition maximum . Participants will perform a leg extension which is a resistance weight training exercise that targets the quadriceps muscle in the legs. The exercise is done using a machine called the Leg Extension Machine. This resistence is measured in pounds.|Baseline, 4 Months|||foot x pounds||Standard Deviation|Mean
831348|NCT01245283|Secondary|Leg Press Test; Change From Baseline at 4 Months|Each participant will do a one repetition maximum. Participants will perform a leg press. The leg press is a weight training exercise in which the individual pushes a weight or resistance away from them using their legs.|Baseline, 4 Months|||foot x pounds||Standard Deviation|Mean
831350|NCT01245283|Secondary|Six Minute Walk Test; Change From Baseline at 4 Months|Each participant will walk at a self-selected pace in the lab around a pre-measured loop for a period of six minutes. Subjects will complete the walk test at the time intervals indicated to document any change. 6 minute walk test is a baseline and 4 month post intervention measurement. It is used to measure distance covered while walking during 6 minutes.|Baseline, 4 Months|||feet||Standard Deviation|Mean
831351|NCT01245283|Primary|Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC Score); Change From Baseline at 4 Months|"The WOMAC is a standard, multidimensional, self-administered functional-health status instrument for patients with lower limb OA. Subjects will complete the self-assessment at the time intervals indicated to document any change in their perception of their functional health status.
Scale for Total score: the higher score means the worst the function and pain Total WOMAC scores will have a range of 0 to 96 (best and worst scores possible).
0-20 Womac pain (0= best, 20=worst) 0-8 Womac stiffness (0= best, 8=worst) 0-68 Womac functional (0= best, 68=worst) 0-96 Womac Total (0= best, 96=worst)"|Baseline, 4 Months|||units on a scale||Standard Deviation|Mean
831352|NCT01245374|Secondary|Number of Participants Reporting Adverse Events, Medical Events of Special Interest (MESI) and Technical Problems With Devices Used in Trial||Weeks 0 - 6|The safety set consisted of all participants included in the trial and having taken at least one dose of trial treatment. The adverse events and technical complaints were collected during the treatment period (6 weeks after inclusion).||participants|||Number
831353|NCT01245374|Secondary|Patient Preference: Percentage of Participants Preferring System for Continuation of Growth Hormone Treatment|The patient preference was evaluated using the percentage of participants preferring the new system, old system or none of them for their growth hormone therapy.|Week 6|Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form. For two patients, no data available.||percentage of participants|||Number
831354|NCT01245374|Secondary|Patient Autonomy: Percentage of Patients Performing Operations for Treatment Injection|The patient autonomy was evaluated using percentage of participants who performed all the operations of the treatment administration including dose selection, dose modification in case of error and injection.|Week 6|Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form.||percentage of participants|||Number
831355|NCT01245374|Secondary|Patient Autonomy: Percentage of Patients Performing Operations for Treatment Injection|The patient autonomy was evaluated using percentage of participants who performed all the operations of the treatment administration including dose selection, dose modification in case of error and injection.|Week 0|Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form.||percentage of participants|||Number
831356|NCT01245374|Secondary|Ease of Learning Assessed by the Physician or the Nurse: Added Values of the Products|The person in charge, physician or nurse, of giving all the instruction of use to patients or parents assessed the ease of learning of the Nordiflex® device. An added value of device was evaluated by the physician or the nurse using categorical variables.|Week 6|Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form.||percentage of participants|||Number
831357|NCT01245374|Secondary|Ease of Learning Assessed by the Physician or the Nurse: Time Learning|The person in charge, physician or nurse, of giving all the instruction of use to patients or parents assessed the ease of learning of the Nordiflex® device. Time to learning was assessed using time intervals: 6-10 minutes, 11-15 minutes, 16-30 minutes and 31 minutes to 1 hour.|Week 6|Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form. For three patients, no data available.||percentage of participants|||Number
831358|NCT01245374|Secondary|Ease of Learning Assessed by the Physician or the Nurse: Ease of Training|The person in charge, physician or nurse, of giving all the instruction of use to patients or parents assessed the ease of learning of the Nordiflex® device. Ease of learning was evaluated using ordinal variables (very easy, easy and difficult).|Week 6|Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form.||percentage of participants|||Number
831359|NCT01245374|Secondary|Percentage of Participants Evaluating Simplicity of Use: Time Spent in the Preparation of the Injection|The overall simplicity of use was evaluated at every step of the injection preparation (dose selection, injection and dose modification) and using the time spent in the preparation of the injection. This was evaluated using time intervals: below 5 minutes, 5-10 minutes, 10-20 minutes.|Week 6|Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form. For one patient, no data available.||percentage of participants|||Number
831360|NCT01245374|Secondary|Percentage of Participants Evaluating Simplicity of Use: Injection Easiness|The overall simplicity of use was evaluated at every step of the injection preparation (dose selection, injection and dose modification) and using the time spent in the preparation of the injection. Ordinal variables were used for the evaluation (very easy, easy, fairly easy, difficult and very difficult).|Week 6|Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form. For one patient, no data available.||percentage of participants|||Number
831361|NCT01245374|Secondary|Percentage of Participants Evaluating Simplicity of Use: Dose Modification|The overall simplicity of use was evaluated at every step of the injection preparation (dose selection, injection and dose modification) and using the time spent in the preparation of the injection. Ordinal variables were used for the evaluation (very easy, easy, fairly easy, difficult and very difficult).|Week 6|Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form. For three patients, no data available.||percentage of participants|||Number
831362|NCT01245374|Secondary|Percentage of Participants Evaluating Simplicity of Use: Dose Selection Easiness|The overall simplicity of use was evaluated at every step of the injection preparation (dose selection, injection and dose modification) and using the time spent in the preparation of the injection. Ordinal variables were used for the evaluation (very easy, easy, fairly easy, difficult and very difficult).|Week 6|"Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form.
For one patient, no data available."||percentage of participants|||Number
831393|NCT01245387|Primary|Number of Participants With PED at Week 24|PED assessed by Investigator at Visit 6, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.|Week 24|FAS; N=number of participants with evaluable data.||Participants|||Number
831363|NCT01245374|Secondary|Percentage of Participants Evaluating Simplicity of Use: Time Spent in the Preparation of the Injection|The overall simplicity of use was evaluated at every step of the injection preparation (dose selection, injection and dose modification) and using the time spent in the preparation of the injection. This was evaluated using time intervals: below 5 minutes, 5-10 minutes, 10-20 minutes.|Week 0|Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form.||percentage of participants|||Number
831364|NCT01245374|Secondary|Percentage of Participants Evaluating Simplicity of Use: Injection Easiness|The overall simplicity of use was evaluated at every step of the injection preparation (dose selection, injection and dose modification) and using the time spent in the preparation of the injection. Ordinal variables were used for the evaluation (very easy, easy, fairly easy, difficult and very difficult).|Week 0|Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form. For three patients, no data available.||percentage of participants|||Number
831365|NCT01245374|Secondary|Percentage of Participants Evaluating Simplicity of Use: Dose Modification|The overall simplicity of use was evaluated at every step of the injection preparation (dose selection, injection and dose modification) and using the time spent in the preparation of the injection. Ordinal variables were used for the evaluation (very easy, easy, fairly easy, difficult and very difficult).|Week 0|Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form. For seven patients, no data available.||percentage of participants|||Number
831366|NCT01245374|Secondary|Percentage of Participants Evaluating Simplicity of Use: Dose Selection Easiness|The overall simplicity of use was evaluated at every step of the injection preparation (dose selection, injection and dose modification) and using the time spent in the preparation of the injection. Ordinal variables were used for the evaluation (very easy, easy, fairly easy, difficult and very difficult).|Week 0|Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form.||percentage of participants|||Number
831367|NCT01245374|Primary|The Relative Ease of Use of NordiFlex® Compared to the Device Previously Used|Analysed for the PP (per protocol) analysis set: The relative ease of use of the trial injection device compared to the device previously used was assessed using a quantitative scale, ranging from 0 to 10 with 0 = NordiFlex® is far less simple, 5 = equivalent simplicity and 10 = NordiFlex® is far more simple. The participants had to circle the number that represented their perception of the current state.|Week 6|Per protocol set (PP): All subjects in the ITT set using NordiFlex® and had completed the trial without any significant violation of the inclusion/exclusion criteria or any other aspect of the protocol considered to potentially affect the efficacy results.||units on a scale||Standard Deviation|Mean
831368|NCT01245374|Primary|The Relative Ease of Use of NordiFlex® Compared to the Device Previously Used|Analysed for the ITT (intent-to-treat) analysis set: The relative ease of use of the trial injection device compared to the device previously used was assessed using a quantitative scale, ranging from 0 to 10 with 0 = NordiFlex® is far less simple, 5 = equivalent simplicity and 10 = NordiFlex® is far more simple. The participants had to circle the number that represented their perception of the current state.|Week 6|Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form.||units on a scale||Standard Deviation|Mean
831369|NCT01245387|Other Pre-specified|IOP Mean Difference (Within a Participant)|Average predose minus postdose mean difference in IOP within a participant|Baseline, every 6 weeks up to Month 24 or early termination|Safety Set; N=number of participants with evaluable data.||mmHg||Standard Deviation|Mean
831370|NCT01245387|Other Pre-specified|Change in IOP Between Predose and Postdose Assessment|IOP measured at each visit using either applanation tonometry or non-contact before and after intraviterial injection. Change in IOP equals postdose IOP minus predose IOP.|Baseline, every 6 weeks up to Month 24 or early termination|Safety Set; N=number of participants with evaluable data; Last Visit: last available postbaseline value.||mmHg||Standard Deviation|Mean
831371|NCT01245387|Other Pre-specified|Intraocular Pressure (IOP)|IOP measured at each visit using either applanation tonometry or non-contact before intraviterial injection, reported as pre-dose pressure of treated eye in millimeters of mercury (mmHg). The timeframe was as follows: Visit 1: IOP before any injection; Visit 2: IOP before first injection; Visit 3: IOP before second injection.|Baseline, every 6 weeks up to Month 24 or early termination|Safety Set; N=number of participants with evaluable data; Last Visit: last available postbaseline value.||mmHg||Standard Deviation|Mean
831372|NCT01245387|Other Pre-specified|Treatment Tolerability|Investigator's overall evaluation of tolerability; Categories included: Very Good, Good, Moderate, and Poor.|Month 24 or early termination|Safety Set; N=number of participants with evaluable data.||Participants|||Number
831373|NCT01245387|Other Pre-specified|Number of Participants With Complications Associated With Injection|Complications associated with injection during the study with onset at or after date of first injection was recorded by the Investigator.|Baseline up to Month 24 or early termination|Safety Set; N=number of participants with evaluable data.||Participants|||Number
831374|NCT01245387|Other Pre-specified|Time to First Adverse Event (AE)|Time to first AE during the study evaluated by Kaplan-Meier Product-limit methods. AE:any untoward medical occurrence in a participant administered a product or medical device in the context of study; the event need not necessarily have a causal relationship with the treatment or usage.|Baseline up to Month 24 or early termination|Safety Set: all participants who received at least 1 Macugen (pegaptanib) injection and provided data post baseline. Data not analyzed due to low number of AEs.||Days||95% Confidence Interval|Median
831375|NCT01245387|Primary|Number of Participants With Angiographic Subtype Reported at Last Visit|Angiographic subtype assessed by Investigator at the Last Visit, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the % classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic). Last Visit: last available postbaseline value.|Month 24 or early termination|FAS; N=number of participants with evaluable data.||Participants|||Number
831376|NCT01245387|Primary|Number of Participants With Angiographic Subtype Reported at Week 54|Angiographic subtype assessed by Investigator at Visit 11, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the % classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).|Week 54|FAS; N=number of participants with evaluable data.||Participants|||Number
831377|NCT01245387|Primary|Number of Participants With Angiographic Subtype Reported at Week 48|Angiographic subtype assessed by Investigator at Visit 10, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the % classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).|Week 48|FAS; N=number of participants with evaluable data.||Participants|||Number
831378|NCT01245387|Primary|Number of Participants With Angiographic Subtype Reported at Week 42|Angiographic subtype assessed by Investigator at Visit 9, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the % classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).|Week 42|FAS; N=number of participants with evaluable data.||Participants|||Number
831379|NCT01245387|Primary|Number of Participants With Angiographic Subtype Reported at Week 36|Angiographic subtype assessed by Investigator at Visit 8, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the % classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).|Week 36|FAS; N=number of participants with evaluable data.||Participants|||Number
831380|NCT01245387|Primary|Number of Participants With Angiographic Subtype Reported at Week 30|Angiographic subtype assessed by Investigator at Visit 7, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent (%) classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).|Week 30|FAS; N=number of participants with evaluable data.||Participants|||Number
831381|NCT01245387|Primary|Number of Participants With Angiographic Subtype Reported at Week 24|Angiographic subtype assessed by Investigator at Visit 6, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent [%] classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).|Week 24|FAS; N=number of participants with evaluable data.||Participants|||Number
831382|NCT01245387|Primary|Number of Participants With Angiographic Subtype Reported at Week 18|Angiographic subtype assessed by Investigator at Visit 5, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent [%] classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).|Week 18|FAS; N=number of participants with evaluable data.||Participants|||Number
831383|NCT01245387|Primary|Number of Participants With Angiographic Subtype Reported at Week 12|Angiographic subtype assessed by Investigator at Visit 4, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent [%] classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).|Week 12|FAS; N=number of participants with evaluable data.||Participants|||Number
831384|NCT01245387|Primary|Number of Participants With Angiographic Subtype Reported at Week 6|Angiographic subtype assessed by Investigator at Visit 3, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent [%] classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).|Week 6|FAS;N=number of participants with evaluable data.||Participants|||Number
831385|NCT01245387|Primary|Number of Participants With Angiographic Subtype Reported at Baseline|Angiographic subtype assessed by Investigator at Baseline, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent [%] classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).|Baseline|FAS; N=number of participants with evaluable data.||Participants|||Number
831386|NCT01245387|Primary|Central Retinal Thickness|Central retinal thickness assessed by Investigator every 6 weeks, as part of SOC, using standard clinical methods practiced (optical coherence tomography) and reported as mean central retinal thickness. The timeframe was as follows: Visit 1: before first injection; Visit 3: 6 weeks after first injection (second injection).|Baseline, every 6 weeks up to Month 24 or early termination|FAS; N=number of participants with evaluable data; Last Visit: last available postbaseline value.||Micrometers (Mcm)||Standard Deviation|Mean
831387|NCT01245387|Primary|Number of Participants With PED at Last Visit|PED assessed by Investigator at Last Visit, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent. Last Visit: last available postbaseline value.|Month 24 or early termination|FAS; N=number of participants with evaluable data.||Participants|||Number
831388|NCT01245387|Primary|Number of Participants With PED at Week 54|PED assessed by Investigator Visit 11, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.|Week 54|FAS; N=number of participants with evaluable data.||Participants|||Number
831389|NCT01245387|Primary|Number of Participants With PED at Week 48|PED assessed by Investigator at Visit 10, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.|Week 48|FAS; N=number of participants with evaluable data.||Participants|||Number
831390|NCT01245387|Primary|Number of Participants With PED at Week 42|PED assessed by Investigator at Visit 9, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.|Week 42|FAS; N=number of participants with evaluable data.||Participants|||Number
831391|NCT01245387|Primary|Number of Participants With PED at Week 36|PED assessed by Investigator at Visit 8, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.|Week 36|FAS; N=number of participants with evaluable data.||Participants|||Number
831392|NCT01245387|Primary|Number of Participants With PED at Week 30|PED assessed by Investigator at Visit 7, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.|Week 30|FAS; N=number of participants with evaluable data.||Participants|||Number
831396|NCT01245387|Primary|Number of Participants With PED at Week 6|PED assessed by Investigator at Visit 3, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.|Week 6|FAS; N=number of participants with evaluable data.||Participants|||Number
831397|NCT01245387|Primary|Number of Participants With Pigment Epithelial Detachment (PED) at Baseline|PED assessed by Investigator at baseline as part of SOC for participants with age-related macular degeneration; Standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.|Baseline|FAS; N=number of participants with evaluable data.||Participants|||Number
831398|NCT01245387|Primary|Number of Participants With a Change in Activity of Neovascular Membrane at Last Visit|Neovascular membrane activity (measured by leakage) assessed by Investigator at the Last Visit, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity. Last Visit: last available postbaseline value.|Month 24 or early termination|FAS; N=number of participants with evaluable data.||Participants|||Number
831399|NCT01245387|Primary|Number of Participants With a Change in Activity of Neovascular Membrane at Week 72|Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 14, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.|Week 72|FAS; N=number of participants with evaluable data.||Participants|||Number
831400|NCT01245387|Primary|Number of Participants With a Change in Activity of Neovascular Membrane at Week 66|Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 13, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.|Week 66|FAS; N=number of participants with evaluable data.||Participants|||Number
831401|NCT01245387|Primary|Number of Participants With a Change in Activity of Neovascular Membrane at Week 60|Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 12, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.|Week 60|FAS; N=number of participants with evaluable data.||Participants|||Number
831402|NCT01245387|Primary|Number of Participants With a Change in Activity of Neovascular Membrane at Week 54|Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 11, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.|Week 54|FAS; N=number of participants with evaluable data.||Participants|||Number
831403|NCT01245387|Primary|Number of Participants With a Change in Activity of Neovascular Membrane at Week 48|Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 10, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.|Week 48|FAS; N=number of participants with evaluable data.||Participants|||Number
831404|NCT01245387|Primary|Number of Participants With a Change in Activity of Neovascular Membrane at Week 42|Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 9, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.|Week 42|FAS; N=number of participants with evaluable data.||Participants|||Number
831405|NCT01245387|Primary|Number of Participants With a Change in Activity of Neovascular Membrane at Week 36|Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 8, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.|Week 36|FAS; N=number of participants with evaluable data.||Participants|||Number
831406|NCT01245387|Primary|Number of Participants With a Change in Activity of Neovascular Membrane at Week 30|Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 7, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.|Week 30|FAS; N=number of participants with evaluable data.||Participants|||Number
831407|NCT01245387|Primary|Number of Participants With a Change in Activity of Neovascular Membrane at Week 24|Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 6, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.|Week 24|FAS; N=number of participants with evaluable data.||Participants|||Number
831408|NCT01245387|Primary|Number of Participants With a Change in Activity of Neovascular Membrane at Week 18|Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 5, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.|Week 18|FAS; N=number of participants with evaluable data.||Participants|||Number
831409|NCT01245387|Primary|Number of Participants With a Change in Activity of Neovascular Membrane at Week 12|Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 4, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.|Week 12|FAS; N=number of participants with evaluable data.||Participants|||Number
831410|NCT01245387|Primary|Number of Participants With a Change in Activity of Neovascular Membrane at Week 6|Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 3, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.|Week 6|FAS; N=number of participants with evaluable data.||Participants|||Number
831434|NCT01245439|Secondary|Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines|ATP III guidelines classify LDL cholesterol >160 mg/dL, Total cholesterol >240 mg/dL, High Density Lipoprotein (HDL) >60 mg/dL and Triglycerides (TG) >199 as elevated.|Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4),12 (Visit 5),16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|Safety population; Number (n) equals (=) number of participants analyzed at the specified visit for the given parameter.||participants|||Number
831411|NCT01245387|Primary|Lesion Size (Number of Optic Disc Areas)|Lesion size measured by Investigator after each injection as part of standard of care (SOC), using standard clinical methods practiced (fluorescein or indocyanine green angiography); Reported as the number of optic-disk areas, each of which were 2.54 millimeters squared (mm^2). Lesion size included choroidal neovascularization, exudation area, and hemorrhage, if present. The timeframe was as follows: Visit 1: before first injection; Visit 3: 6 weeks after first injection (second injection).|Baseline, every 6 weeks up to Month 24 or early termination|FAS; N=number of participants with evaluable data; Last Visit: last available postbaseline value.||number of optic disc areas||Standard Deviation|Mean
831412|NCT01245387|Primary|Number of Participants With Investigator Assessments of Efficacy|Investigator's categorical assessment of the efficacy of Macugen (pegaptanib) treatment at the final visit or termination of therapy; Categories included Very Good, Good, Moderate, and Poor.|Month 24 or early termination|FAS; N = number of participants with evaluable data.||Participants|||Number
831413|NCT01245387|Primary|Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25): Overall Composite Score|Participant-reported vision-related functioning and quality of life measured using the 25 item NEI-VFQ-25. Converted scale 0-100 where higher score represented better functioning: General Health: item 1; General Vision: item 2; Ocular Pain: 4,19; Near Vision: 5,6,7; Distance Vision: 8,9,14; Social Functioning: 11,13; Mental Health Activities: 3,21,22,25; Role Difficulties: 17,18; Dependency: 20,23,24; Driving: 15c,16, 16a; Color Vision: 12; Peripheral Vision: 10.|Baseline, every 6 months up to Month 24 or early termination|FAS; N=number of participants with evaluable data; Last Visit: last available postbaseline value.||Scores on a scale||Standard Deviation|Mean
831414|NCT01245387|Primary|Visual Acuity (VA)|VA measured at each follow-up visit as the number of lines read on a standard eye chart (Snellen or Early Treatment Diabetic Retinopathy Study [EDTRS]) using a 5 meter distance, 1 meter distance, or verifying if participant was able to count fingers, perceive hand motion, or light. Follow-up visits occurred only if considered part of standard medical treatment. The timeframe was as follows: Visit 1: before first injection; Visit 2: first injection; Visit 3: 6 weeks after first injection (second injection).|Baseline, every 6 weeks up to Month 24 or early termination|Full Analysis Set (FAS):participants who received at least 1 Macugen (pegaptanib) injection and had at least 1 VA measurement postbaseline. Participants with light perception or no light perception any time during study were excluded from FAS; N=participants with evaluable data; Last Visit: last available postbaseline value.||lines of VA||Standard Deviation|Mean
831415|NCT01245413|Primary|Visual Inspection of Baseplate Loosening|The area of the adhesive that was detached from the skin based on visual evaluation of the Athena and Sensura adhesives on the stomach after 1 hour of cycling at moderate intensity. The evaluation was done by marking the detached areas at the baseplate on a transparent wound tracing sheet with a permanent marker. Subsequently the areas were measured by scanning the tracing sheet and calculating the area with the use of Imagepro image macro which calculates the result in cm^2|1 hour|ITT||cm^2||Standard Deviation|Mean
831416|NCT01245439|Secondary|Health Assessment Questionnaire Score (General Score)|The Stanford HAQ disability index is a participant completed questionnaire specific for RA. It consists of 20 questions referring to 8 component sections: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. The questionnaire was provided in validated translation into the local languages at the participating sites and was scored. Every question in each section was scored at a scale from 0 to 3 by the participant where 0 = able to perform the activity without any difficulty and 3 = unable to perform the activity. General score was calculated as an average of the 8 sections.|Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|ITT population||units on a scale||Standard Deviation|Mean
831417|NCT01245439|Secondary|Participant's Assessment of Pain|VAS is a visual scale of 100 mm for the assessment of disease activity by participants or investigator. Disease activity/pain increases while approaching 100 mm. For the screening visit (baseline visit) there's only investigator assessment data, for other visits participant's pain assessment, participant's disease activity assessment and investigator's disease activity assessment parameters were collected.|Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|ITT population||mm||Standard Deviation|Mean
831418|NCT01245439|Secondary|Participant's (PT) and Investigator's (IN) Assessment of Disease Activity|VAS is a visual scale of 100 mm for the assessment of disease activity by participants or investigator. Disease activity/pain increases while approaching 100 mm. For the screening visit (baseline visit) there's only investigator assessment data, for other visits participant's pain assessment, participant's disease activity assessment and investigator's disease activity assessment parameters were collected.|Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|ITT population||mm||Standard Deviation|Mean
831419|NCT01245439|Secondary|Mean Number of Tender and Swollen Joints|Participants were asked to classify 28 joints as tender or not tender and swollen or not swollen to count the total number of tender and swollen joints by visit.|Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|ITT population||joints||Standard Deviation|Mean
831420|NCT01245439|Secondary|Erythrocyte Sedimentation Rate|ESR is an inflammatory marker used to measure inflammation in RA and is measured as millimeters per hour (mm/hr).|Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|ITT population; number of participants analyzed = participants who were evaluable for this outcome and n = participants who were evaluable for specified category||mm/hr||Standard Deviation|Mean
831421|NCT01245439|Secondary|C-Reactive Protein Levels|CRP is an inflammatory marker used to measure inflammation in RA and is measured as mg/dL.|Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|ITT population; number of participants analyzed = participants who were evaluable for this outcome and n = participants who were evaluable for specified category.||mg/dL||Standard Deviation|Mean
831435|NCT01245439|Secondary|Change From Baseline to Lowest Value for Absolute Neutrophil Count (ANC)|ANC is a measure of number of neutrophil granulocytes. An ANC less than 500 cells per microliter (cells/µL) is defined as neutropenia and significantly increases risk of infection. The change from baseline was calculated as: baseline value minus the highest value observed post-baseline. ANC was measured in cells/µL.|Baseline to Week 24|Safety population||cells/µL||Standard Deviation|Mean
831422|NCT01245439|Secondary|Percentage of Participants Who Achieved ACR 20, ACR 50, ACR 70 and ACR 90 Response|ACR20/50/70/90 response: ≥ 20/50/70/90 % improvement in TJC; ≥20/50/70/90% improvement in SJC; and ≥20/50/70/90% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP). Improvements were assessed on the basis of prior visit. .|Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4),12 (Visit 5),16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|ITT population; number of participants analyzed = participants who were evaluable for this outcome.||Percentage of participants|||Number
831423|NCT01245439|Secondary|Number of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, ACR 70 and ACR 90 Response|ACR20/50/70/90 response: greater than or equal to (≥) 20/50/70/90 percent (%) improvement in TJC; ≥20/50/70/90% improvement in SJC; and ≥20/50/70/90% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP). Improvements were assessed on the basis of prior visit.|Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4),12 (Visit 5),16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|ITT population; number of participants analyzed = participants who were evaluable for this outcome.||participants|||Number
831424|NCT01245439|Secondary|Disease Activity Score as Measured By DAS28 at Each Visit|"The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen and tender joint counts, acute phase response, and general health status. The DAS28, which uses a 28 joint count, is derived from the original DAS. The index is calculated using the following formula:
DAS28 = 0.56 x (TJC28)^0.5 + 0.28 x (SJC28)^0.5 + 0.70 x In(ESR) + 0.014 x GH Where TJC28 = tender joint count on 28 joints, SJCz8 = swollen joint count on 28 joints, ın = natural log, ESR = erythrocyte sedimentation rate and GH = general health (participant's global assessment of disease activity). DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of < 2.6 represents clinical remission, a score of: <3.2 LDA, and a score of > 5.1 represents severe disease. A reduction of at least 1.2 units in DAS28 is considered to be a clinically meaningful improvement."|Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|ITT population. n = participants who were evaluable for specified category||units on a scale||Standard Deviation|Mean
831425|NCT01245439|Secondary|Percentage of Participants Achieving Their First Remission Status By Visit|"The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen and tender joint counts, acute phase response, and general health status. The DAS28, which uses a 28 joint count, is derived from the original DAS. The index is calculated using the following formula:
DAS28 = 0.56 x (TJC28)^0.5 + 0.28 x (SJC28)^0.5 + 0.70 x In(ESR) + 0.014 x GH Where TJC28 = tender joint count on 28 joints, SJCz8 = swollen joint count on 28 joints, ın = natural log, ESR = erythrocyte sedimentation rate and GH = general health (participant's global assessment of disease activity). DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of < 2.6 represents clinical remission, a score of: <3.2 LDA, and a score of > 5.1 represents severe disease. A reduction of at least 1.2 units in DAS28 is considered to be a clinically meaningful improvement."|Weeks 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome.||Percentage of participants|||Number
831426|NCT01245439|Secondary|Percentage of Participants Who Achieved Remission (DAS28) At Every Visit|"The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen and tender joint counts, acute phase response, and general health status. The DAS28, which uses a 28 joint count, is derived from the original DAS. The index is calculated using the following formula:
DAS28 = 0.56 x (TJC28)^0.5 + 0.28 x (SJC28)^0.5 + 0.70 x In(ESR) + 0.014 x GH Where TJC28 = tender joint count on 28 joints, SJCz8 = swollen joint count on 28 joints, ın = natural log, ESR = erythrocyte sedimentation rate and GH = general health (participant's global assessment of disease activity). DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of < 2.6 represents clinical remission, a score of: <3.2 LDA, and a score of > 5.1 represents severe disease. A reduction of at least 1.2 units in DAS28 is considered to be a clinically meaningful improvement."|Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome and n = participants who were evaluable for specified category.||percentage of participants|||Number
831427|NCT01245439|Secondary|Number of Participants Who Achieved Remission (DAS28) By Visit|"The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen and tender joint counts, acute phase response, and general health status. The DAS28, which uses a 28 joint count, is derived from the original DAS. The index is calculated using the following formula:
DAS28 = 0.56 x (TJC28)^0.5 + 0.28 x (SJC28)^0.5 + 0.70 x In(ESR) + 0.014 x GH Where TJC28 = tender joint count on 28 joints, SJCz8 = swollen joint count on 28 joints, ın = natural log, ESR = erythrocyte sedimentation rate and GH = general health (participant's global assessment of disease activity). DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of < 2.6 represents clinical remission, a score of: <3.2 LDA, and a score of > 5.1 represents severe disease. A reduction of at least 1.2 units in DAS28 is considered to be a clinically meaningful improvement."|Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|ITT population. Number of participants analyzed = participants who were evaluable for this outcome and n = participants who were evaluable for specified category||participants|||Number
831436|NCT01245439|Secondary|Change From Baseline to Highest Values for Low Density Lipoprotein (LDL) and Total Cholesterol|Elevations in LDL and total cholesterol could lead to heart disease. The change from baseline was calculated as: baseline value minus the highest value observed post-baseline and was measured as milligrams per deciliter (mg/dL).|Baseline to Week 24|Safety population; number of participants analyzed signifies participants who were evaluable for this outcome.||mg/dL||Standard Deviation|Mean
831437|NCT01245439|Secondary|Change From Baseline to Highest Values for ALT and AST|Elevations in ALT and AST could indicate hepatotoxicity. These enzymes were measured as International Units per Liter (IU/L). The change from baseline was calculated as: baseline value minus the highest value observed post-baseline for each enzyme.|Baseline to Week 24|Safety population||IU/L||Standard Deviation|Mean
831428|NCT01245439|Secondary|Time to LDA (DAS28 ) Based on First Visit When LDA Was Observed|"The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen and tender joint counts, acute phase response, and general health status. The DAS28, which uses a 28 joint count, is derived from the original DAS. The index is calculated using the following formula:
DAS28 = 0.56 x (TJC28)^0.5 + 0.28 x (SJC28)^0.5 + 0.70 x In(ESR) + 0.014 x GH Where TJC28 = tender joint count on 28 joints, SJCz8 = swollen joint count on 28 joints, ın = natural log, ESR = erythrocyte sedimentation rate and GH = general health (participant's global assessment of disease activity). DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of < 2.6 represents clinical remission, a score of: <3.2 LDA, and a score of > 5.1 represents severe disease. A reduction of at least 1.2 units from previous visit in DAS28 is considered to be a clinically meaningful improvement."|Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|ITT Population; Number of participants analyzed = participants who were evaluable for this outcome||Percentage of participants|||Number
831429|NCT01245439|Secondary|Percentage of Participants Who Achieved LDA By Visit|"TThe DAS28 is a combined index for measuring disease activity in RA. The index includes swollen and tender joint counts, acute phase response, and general health status. The DAS28, which uses a 28 joint count, is derived from the original DAS. The index is calculated using the following formula:
DAS28 = 0.56 x (TJC28)^0.5 + 0.28 x (SJC28)^0.5 + 0.70 x In(ESR) + 0.014 x GH Where TJC28 = tender joint count on 28 joints, SJCz8 = swollen joint count on 28 joints, ın = natural log, ESR = erythrocyte sedimentation rate and GH = general health (participant's global assessment of disease activity). DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of < 2.6 represents clinical remission, a score of: <3.2 represents LDA, and a score of > 5.1 represents severe disease. A reduction of at least 1.2 units from previous visit in DAS28 is considered to be a clinically meaningful improvement."|Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|ITT Population; Number of participants analyzed = participants who were evaluable for this outcome and n = number of participants who were evaluable for the specified category.||percentage of participants|||Number
831430|NCT01245439|Secondary|Number of Participants Who Achieved LDA By Visit|"The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen and tender joint counts, acute phase response, and general health status. The DAS28, which uses a 28 joint count, is derived from the original DAS. The index is calculated using the following formula:
DAS28 = 0.56 x (TJC28)^0.5 + 0.28 x (SJC28)^0.5 + 0.70 x In(ESR) + 0.014 x GH Where TJC28 = tender joint count on 28 joints, SJCz8 = swollen joint count on 28 joints, ın = natural log, ESR = erythrocyte sedimentation rate and GH = general health (participant's global assessment of disease activity). DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of < 2.6 represents clinical remission, a score of: <3.2 represents LDA, and a score of > 5.1 represents severe disease. A reduction of at least 1.2 units from previous visit in DAS28 is considered to be a clinically meaningful improvement."|Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|ITT Population; Number of participants analyzed = participants who were evaluable for this outcome and n = number of participants who were evaluable for the specified category.||participants|||Number
831431|NCT01245439|Secondary|Percentage of Participants Who Achieved Clinically Meaningful Improvement in DAS28 At Every Visit|"The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen and tender joint counts, acute phase response, and general health status. The DAS28, which uses a 28 joint count, is derived from the original DAS. The index is calculated using the following formula:
DAS28 = 0.56 x (TJC28)^0.5 + 0.28 x (SJC28)^0.5 + 0.70 x In(ESR) + 0.014 x GH Where TJC28 = tender joint count on 28 joints, SJCz8 = swollen joint count on 28 joints, ın = natural log, ESR = erythrocyte sedimentation rate and GH = general health (participant's global assessment of disease activity). DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of < 2.6 represents clinical remission, a score of: < 3.2 represents LDA, and a score of > 5.1 represents severe disease. A reduction of at least 1.2 units from previous visit in DAS28 is considered to be a clinically meaningful improvement."|Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4),12 (Visit 5),16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|ITT Population; Number of participants analyzed = participants who were evaluable for this outcome and n = participants who were evaluable for specified category.||percentage of participants|||Number
831432|NCT01245439|Secondary|Number of Participants Who Achieved Clinically Meaningful Improvement in Disease Activity Score 28 (DAS28) At Every Visit|"The DAS28 is a combined index for measuring disease activity in Rheumatoid Arthritis (RA). The index includes swollen and tender joint counts, acute phase response, and general health status. The DAS28, which uses a 28 joint count, is derived from the original DAS. The index is calculated using the following formula:
DAS28 = 0.56 x (TJC28)^0.5 + 0.28 x (SJC28)^0.5 + 0.70 x In(ESR) + 0.014 x GH Where TJC28 = tender joint count on 28 joints, SJCz8 = swollen joint count on 28 joints, ın = natural log, ESR = erythrocyte sedimentation rate and GH = general health (participant's global assessment of disease activity). DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of less than (<) 2.6 represents clinical remission, a score of: <3.2 represents low disease activity (LDA), and a score of > 5.1 represents severe disease. A reduction from previous visit of at least 1.2 units in DAS28 is considered to be a clinically meaningful improvement."|Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|Intent- to- Treat (ITT) Population: all enrolled participants who received at least one dose of study medication. Number of participants analyzed = participants who were evaluable for this outcome and n = participants who were evaluable for specified category||participants|||Number
831433|NCT01245439|Secondary|Percentage of Participants With Elevations in Lipids According to ATP III Guidelines|ATP III guidelines classify LDL cholesterol >160 mg/dL , Total cholesterol >240 mg/dL, HDL >60 mg/dL and TG >199 as elevated.|Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|Safety population; n = number of participants analyzed at the specified visit for the given parameter.||percentage of participants|||Number
831565|NCT01246479|Primary|Rate of Subjects With PRNT50 Titers of ≥ 1:10 at Month 12 After the First IC51 Vaccination (in Study IC51-322)|Rate of subjects with PRNT50 titers of ≥ 1:10 at Month 12 after the first IC51 vaccination (in study IC51-322)|Month 12|intention to treat population; assessment of seroprotection ~1 year post primary vaccination series in parent study IC51-322||percentage of participants||95% Confidence Interval|Number
831438|NCT01245439|Secondary|Number of Participants With Serious Infections|A serious infection was an infection which was also considered as an SAE. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly|Weeks 4 (Visit 3), 8 (Visit 4), and 16 (Visit 6)|Safety population||participants|||Number
831439|NCT01245439|Secondary|Percentage of Participants With Serious Infections|A serious infection was an infection which was also considered as an SAE. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly|Weeks 4 (Visit 3), 8 (Visit 4), and 16 (Visit 6)|Safety population||percentage of participants|||Number
831440|NCT01245439|Secondary|Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN|Elevations in ALT and AST could indicate hepatotoxicity.|Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|Safety population||percentage of participants|||Number
831441|NCT01245439|Secondary|Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN|Elevations in ALT and AST could indicate hepatotoxicity.|Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|Safety population||participants|||Number
831442|NCT01245439|Secondary|Percentage of Participants With All-Cause Discontinuation|Participants who discontinued treatment due to any reason were included in this measure.|24 weeks|Safety population||percentage of participants|||Number
831443|NCT01245439|Primary|Safety: Percentage of Participants With Treatment Emergent Adverse /Serious Adverse Events|An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. An AE was considered treatment emergent if the date of onset of the AE was on or after the date of first dose of study medication. AEs of special interest included Major Adverse Cardiovascular Events (MACE) (including strokes), infections, and infusion reactions. An AE was considered an infection if the preferred term was in the predefined infection AE group term. A serious infection was an infection which was also considered as an AE. An AE was considered an infusion reaction if it occurred during or within 24 hours of an infusion.|24 weeks|The safety population consisted of all participants included in the study who received at least one dose of study medication and who had at least one post-baseline assessment of safety (that is post-baseline laboratory data, vital signs or adverse events).||percentage of participants|||Number
831444|NCT01245595|Primary|Acute Kidney Injury Measured by Kidney Diseases: Improving Global Outcomes (KDIGO) AKI Serum Creatinine Criteria|Acute Kidney Injury measured by Kidney Diseases: Improving Global Outcomes (KDIGO) AKI Serum Creatinine criteria; KDIGO Stage is a measure of acute kidney injury.|5 days|||participants|||Number
831445|NCT01245647|Secondary|CD4 Count (Mean)|Results from CD4 cell count result obtained either as lab specifically for this study, or from lab results that were collected at the same time point for a different study or clinical indication.|4 months|||CD4 count (cells/ml)||Standard Deviation|Mean
831446|NCT01245647|Secondary|HIV Viral Load Suppressed|Viral load was classified as either suppressed (HIV viral load <50 copies/ml) or not suppressed (HIV viral load >50 copies/ml). We report the proportion of participants who had a suppressed viral load (higher number is better)|4 months|||percentage of persons with suppressed VL|||Number
831447|NCT01245647|Secondary|Risky Sexual Behaviors|Risky sexual behavior was a dichotomous outcome for each participant at each time point, defined as having any non-condom-protected sex with a males who have an unknown/negative HIV status in the previous 30 days.|4 months|||percentage of persons with risky sex|||Number
831448|NCT01245647|Secondary|HIV Medication Adherence (95% or Better)|Medication adherence was measured on a visual analogue scale ranging from 0 - 100, and indicating what percentage of the persons' HIV medication was taken on schedule over the past week (self-report). A score of 95% or better was considered adherent, and we report the proportion of persons who were adherent in each group.|Month 4|Only persons who reported current HIV medication use (n=13) were considered for this outcome, and we included data from the 10 persons who completed the 4-month assessment.||percentage of participants|||Number
831449|NCT01245647|Primary|Number of Drinks Per Week|Average number of standard alcohol drinks per week, as measured by timeline follow-back. A drink typically contains about 0.6 grams of alcohol, and generally represents 1 12-oz beer, 1 5-oz glass of wine, or one shot of liquor.|Month 4|All participants who provided data at the 4-month follow-up were included (n=15), which is 79% of persons who were randomized.||standard alcohol drinks per week||Standard Deviation|Mean
831450|NCT01245738|Primary|Percentage of Participants Who Achieved Target Lipid Levels of HDL-C But Did Not Achieve Target Lipid Levels for TG and LDL-C After 12 Weeks of Treatment With Statins|The percentage of participants who achieved predefined lipid target levels after 12 weeks of treatment with statins. Predefined lipid target levels were: LDL-C less than 70 mg/dL, HDL-C greater than 40 mg/dL, and TG less than 150 mg/dL.|Week 12|Participants of the FAS Population who had HDL-C, TG, and LDL-C measurements and Week 12.||Percentage of Participants|||Number
831451|NCT01245738|Primary|Percentage of Participants Who Achieved Target Lipid Levels for TG But Did Not Achieve Target Lipid Levels for HDL-C and LDL-C After 12 Weeks of Treatment With Statins|The percentage of participants who achieved predefined lipid target levels after 12 weeks of treatment with statins. Predefined lipid target levels were: LDL-C less than 70 mg/dL, HDL-C greater than 40 mg/dL, and TG less than 150 mg/dL.|Week 12|Participants of the FAS Population who had HDL-C, TG, and LDL-C measurements and Week 12.||Percentage of Participants|||Number
831452|NCT01245738|Primary|Percentage of Participants Who Did Not Achieve Target Lipid Levels for LDL-C, HDL-C, and TG After 12 Weeks of Treatment With Statins|The percentage of participants who achieved predefined lipid target levels after 12 weeks of treatment with statins. Predefined lipid target levels were: LDL-C less than 70 mg/dL, HDL-C greater than 40 mg/dL, and TG less than 150 mg/dL.|Week 12|Participants of the FAS Population who had HDL-C, TG, and LDL-C measurements and Week 12.||Percentage of Participants|||Number
831453|NCT01245738|Primary|Percentage of Participants Who Achieved Target Lipid Levels of HDL-C and LDL-C But Did Not Achieve Target Lipid Levels for TG After 12 Weeks of Treatment With Statins|The percentage of participants who achieved predefined lipid target levels after 12 weeks of treatment with statins. Predefined lipid target levels were: LDL-C less than 70 mg/dL, HDL-C greater than 40 mg/dL, and TG less than 150 mg/dL.|Week 12|Participants of the FAS Population who had HDL-C, TG, and LDL-C measurements and Week 12.||Percentage of Participants|||Number
831454|NCT01245738|Primary|Percentage of Participants Who Achieved Target Lipid Levels for TG and LDL-C But Did Not Achieve Target Lipid Levels for HDL-C After 12 Weeks of Treatment With Statins|The percentage of participants who achieved predefined lipid target levels after 12 weeks of treatment with statins. Predefined lipid target levels were: LDL-C less than 70 mg/dL, HDL-C greater than 40 mg/dL, and TG less than 150 mg/dL.|Week 12|Participants of the FAS Population who had HDL-C, TG, and LDL-C measurements and Week 12.||Percentage of Participants|||Number
831455|NCT01245738|Primary|Percentage of Participants Who Achieved Target Lipid Levels for LDL-C But Did Not Achieve Target Lipid Levels for HDL-C and TG After 12 Weeks of Treatment With Statins|The percentage of participants who achieved predefined lipid target levels after 12 weeks of treatment with statins. Predefined lipid target levels were: LDL-C less than 70 mg/dL, HDL-C greater than 40 mg/dL, and TG less than 150 mg/dL.|Week 12|Participants of the FAS Population who had HDL-C, TG, and LDL-C measurements at Week 12.||Percentage of Participants|||Number
831456|NCT01245738|Primary|Change From Baseline in TG Levels After 12 Weeks of Treatment With Statins|TG levels were measured after 12 weeks of treatment with a statin. The change from baseline was calculated as the difference between Baseline and Week 12 values.|Baseline and at Week 12|Participants of the FAS Population who had TG measurements at baseline and Week 12.||mg/dL||Standard Deviation|Mean
831457|NCT01245738|Primary|Change From Baseline in HDL-C Levels After 12 Weeks of Treatment With Statins|HDL-C levels were measured after 12 weeks of treatment with a statin. The change from baseline was calculated as the difference between baseline and Week 12 values.|Baseline and at Week 12|Participants of the FAS Population who had HDL-C measurements at baseline and Week 12.||mg/dL||Standard Deviation|Mean
831458|NCT01245738|Primary|Change From Baseline in LDL-C Levels After 12 Weeks of Treatment With Statins|LDL-C levels were measured after 12 weeks of treatment with a statin. The change from baseline was calculated as the difference between baseline and Week 12 values.|Baseline and at Week 12|Participants of the FAS Population who had LDL-C measurements at baseline and Week 12.||mg/dL||Standard Deviation|Mean
831459|NCT01245738|Primary|Change From Baseline in TC Levels After Treatment|TC levels were measured after 12 weeks of treatment with a statin. The change from baseline was calculated as the difference between baseline and Week 12 values.|Baseline and at Week 12|Participants of the Full Analysis Set (FAS) Population who had a TC measurements at baseline and Week 12.||mg/dL||Standard Deviation|Mean
831460|NCT01245738|Primary|Triglycerides (TG) Levels at First Acute Coronary Event|At the time of hospital admission for a first acute coronary event, the TG levels of eligible participants were taken. This level was considered the baseline value. A TG level of >150 mg/dL is considered an abnormal lipid value (dyslipidemia).|At hospital presentation (Day 1)|Participants who had a TG measurement at baseline.||mg/dL||Standard Deviation|Mean
831461|NCT01245738|Primary|High-Density Lipoprotein Cholesterol (HDL-C) Levels at First Acute Coronary Event|At the time of hospital admission for a first acute coronary event, the HDL-C levels of eligible participants were taken. This level was considered the baseline value. A HDL-C level of <40 mg/dL is considered an abnormal lipid value (dyslipidemia).|At hospital presentation (Day 1)|Participants who had a HDL-C measurement at baseline.||mg/dL||Standard Deviation|Mean
831462|NCT01245738|Primary|Low-Density Lipoprotein Cholesterol (LDL-C) Levels at First Acute Coronary Event|At the time of hospital admission for a first acute coronary event, the LDL-C levels of eligible participants were taken. This level was considered the baseline value. A LDL-C level of >70 mg/dL is considered an abnormal lipid value (dyslipidemia).|At hospital presentation (Day 1)|Participants who had a LDL-C measurement at baseline.||mg/dL||Standard Deviation|Mean
831463|NCT01245738|Primary|Total Cholesterol (TC) Levels at First Acute Coronary Event|At the time of hospital admission for a first acute coronary event, the TC levels of eligible participants were taken. This level was considered the baseline value. A TC level of >240 mg/dL is considered an abnormal lipid value (dyslipidemia).|At hospital presentation (Day 1)|Participants who had a total cholesterol measurement at baseline.||mg/dL||Standard Deviation|Mean
831464|NCT01245751|Secondary|Number of Participants Reporting One or More Adverse Experiences|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse experience. A serious adverse experience is any AE that results in death, is life threatening, results in persistent disability/incapacity, results in or prolongs existing inpatient hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is another important medical event that may jeopardize the participant and may require medical or surgical intervention. Vaccine-related AEs were those assessed by the investigator as definitely, probably, or possibly related to vaccine administration. This outcome measure applies only to AEs collected after vaccination in Part 1 of the current study.|Up to 42 days postvaccination|Analysis included all vaccinated participants who had any safety follow-up||Participants|||Number
831465|NCT01245751|Primary|Geometric Mean Fold Rise (GMFR) From Day 1 (Baseline) to Week 6 Postvaccination in VZV Antibody Titers|VZV antibody titers were determined by gpELISA. The GMFR measures the rise in VZV antibodies from Day 1 (Baseline) to Week 6 postvaccination.|Day 1 (Baseline) and Week 6 postvaccination|Analysis included all vaccinated participants except those who had protocol deviations that interfered with the assessment of VZV antibody response, who developed varicella or herpes zoster rashes before a blood sample was taken, or who reported exposure to varicella or herpes zoster. The planned analysis included Group 1 only.||Fold Rise||95% Confidence Interval|Geometric Mean
831480|NCT01246076|Secondary|Time to Progression|The time to progression is defined as the time from registration to the date of progression or last follow-up. Those who die will be considered to have had disease progression unless documented evidence clearly indicates no progression has occurred.|Up to 6 months after completion of treatment (up to 82 weeks from start of treatment)|Time to progression was not analyzed. This was a prespecified secondary outcome but due to the early termination of the study time to progression was not followed.|||||
831466|NCT01245751|Primary|Geometric Mean Titer (GMT) of the Antibody Responses to Varicella-Zoster Virus (VZV)|VZV antibody titers were determined by glycoprotein enzyme-linked immunosorbent assay (gpELISA)|Day 1 (Baseline) and Week 6 postvaccination|Analysis included all vaccinated participants except those who had protocol deviations that interfered with the assessment of VZV antibody response, who developed varicella or herpes zoster rashes before a blood sample was taken, or who reported exposure to varicella or herpes zoster. The planned analysis included Group 1 versus Group 2 only.||gpELISA Units/mL||95% Confidence Interval|Geometric Mean
831467|NCT01245764|Secondary|GMT of Anti-HPV Type 18 Antibody|Anti-HPV Type 18 antibodies were measured by cLIA. The seropositive cut-off threshold for this assay is defined as 24 milli Merck U/mL.|Month 7 (1 month postdose 3 in study Phase A)|Participants analyzed included those who received all 3 vaccinations in study Phase A and provided a sample for Month 7 serology testing. This analysis pooled results for participants receiving GARDASIL and compared these with results for participants receiving placebo.||milli Merck U/mL||95% Confidence Interval|Geometric Mean
831468|NCT01245764|Secondary|GMT of Anti-HPV Type 16 Antibody|Anti-HPV Type 16 antibodies were measured by cLIA. The seropositive cut-off threshold for this assay is defined as 20 milli Merck U/mL.|Month 7 (1 month postdose 3 in study Phase A)|Participants analyzed included those who received all 3 vaccinations in study Phase A and provided a sample for Month 7 serology testing. This analysis pooled results for participants receiving GARDASIL and compared these with results for participants receiving placebo.||milli Merck U/mL||95% Confidence Interval|Geometric Mean
831469|NCT01245764|Secondary|GMT of Anti-HPV Type 11 Antibody|Anti-HPV Type 11 antibodies were measured by cLIA. The seropositive cut-off threshold for this assay is defined as 16 milli Merck U/mL.|Month 7 (1 month postdose 3 in study Phase A)|Participants analyzed included those who received all 3 vaccinations in study Phase A and provided a sample for Month 7 serology testing. This analysis pooled results for participants receiving GARDASIL and compared these with results for participants receiving placebo.||milli Merck U/mL||95% Confidence Interval|Geometric Mean
831470|NCT01245764|Secondary|Geometric Mean Titer (GMT) of Anti-HPV Type 6 Antibody|Anti-HPV Type 6 antibodies were measured by cLIA. The seropositive cut-off threshold for this assay is defined as 20 milli Merck U/mL.|Month 7 (1 month postdose 3 in study Phase A)|Participants analyzed included those who received all 3 vaccinations in study Phase A and provided a sample for Month 7 serology testing. This analysis pooled results for participants receiving GARDASIL and compared these with results for participants receiving placebo.||milli Merck U/mL||95% Confidence Interval|Geometric Mean
831471|NCT01245764|Primary|Number of Participants With Serious Adverse Experiences|A serious adverse experience is any adverse experience that results in death, is life threatening, results in persistent or significant disability/incapacity, results in or prolongs existing inpatient hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is another important medical event that may jeopardize the participant and may require medical or surgical intervention|From the time of informed consent is signed through the last study visit (up to 19 months)|The analysis included all participants receiving at least 1 vaccination in study Phase A or B and who had postvaccination follow-up||Participants|||Number
831472|NCT01245764|Primary|Number of Participants With Elevated Temperature (Oral Temperature >=100 °F)||Up to Day 5 after any vaccination in study Phase A|The analysis included all participants receiving at least 1 vaccination in study Phase A and who had temperature data||Participants|||Number
831473|NCT01245764|Primary|Number of Participants With Injection-site Adverse Experiences|Participants were prompted to report injection-site experiences of pain, erythema, or swelling and were also asked to report any other injection-site adverse experiences|Up to Day 5 after any vaccination in study Phase A|The analysis included all participants receiving at least 1 vaccination in study Phase A and who had postvaccination follow-up||Participants|||Number
831474|NCT01245764|Primary|Number of Participants Who Seroconvert to HPV Type 18|Seroconversion was defined as achieving an anti-HPV Type 18 cLIA level of >=24 milli Merck U/mL. The dilution-corrected limit of detection for the Type 18 cLIA was 5.8 milli Merck U/mL.|Month 7 (1 month postdose 3 in study Phase A)|Participants analyzed included those who received all 3 vaccinations in study Phase A and provided a sample for Month 7 serology testing. This analysis pooled results for participants receiving GARDASIL and compared these with results for participants receiving placebo.||Participants|||Number
831475|NCT01245764|Primary|Number of Participants Who Seroconvert to HPV Type 16|Seroconversion was defined as achieving an anti-HPV Type 16 cLIA level of >=20 milli Merck U/mL. The dilution-corrected limit of detection for the Type 16 cLIA was 9.7 milli Merck U/mL.|Month 7 (1 month postdose 3 in study Phase A)|Participants analyzed included those who received all 3 vaccinations in study Phase A and provided a sample for Month 7 serology testing. This analysis pooled results for participants receiving GARDASIL and compared these with results for participants receiving placebo.||Participants|||Number
831476|NCT01245764|Primary|Number of Participants Who Seroconvert to HPV Type 11|Seroconversion was defined as achieving an anti-HPV Type 11 cLIA level of >=16 milli Merck U/mL. The dilution-corrected limit of detection for the Type 11 cLIA was 3.9 milli Merck U/mL.|Month 7 (1 month postdose 3 in study Phase A)|Participants analyzed included those who received all 3 vaccinations in study Phase A and provided a sample for Month 7 serology testing. This analysis pooled results for participants receiving GARDASIL and compared these with results for participants receiving placebo.||Participants|||Number
831477|NCT01245764|Primary|Number of Participants Who Seroconvert to Human Papillomavirus (HPV) Type 6|Seroconversion was defined as achieving an anti-HPV Type 6 competitive Luminex Immunoassay (cLIA) level of >=20 milli Merck U/mL. The dilution-corrected limit of detection for the Type 6 cLIA was 4.2 milli Merck U/mL.|Month 7 (1 month postdose 3 in study Phase A)|Participants analyzed included those who received all 3 vaccinations in study Phase A and provided a sample for Month 7 serology testing. This analysis pooled results for participants receiving GARDASIL and compared these with results for participants receiving placebo.||Participants|||Number
831478|NCT01246011|Secondary|Major Bleeding Events.|Intracranial bleed or any clinically overt sign of hemorrhage that is associated with a fall in hemoglobin > 5 g/dL.|At 2weeks post CABG||||||
831479|NCT01246011|Primary|Coronary Artery Bypass Vein Graft Patency|Vein graft patency as measured by computed tomography|Approximately 30 Days post CABG|No analysis will be done due to early study termination||Vein Grafts|||Number
831481|NCT01246076|Secondary|Toxicity as Measured by Number of Participants Who Experienced Related Grade 3-5 Adverse Events Based on CTCAE Version 4||30 days after end of treatment (up to 60 weeks)|||participants|||Number
831485|NCT01246076|Primary|Number of Participants With Confirmed Responses (Complete Remission, Partial Remission, or Hematologic Improvement) as Defined by the International Working Group Criteria|"Complete remission (CR): ≤5% myeloblasts bone marrow blasts, normal maturation in all cell lines (dysplasia will be noted), ≥11 g/dl peripheral blood hemoglobin, ≥100x10^9cells/μL peripheral blood platelets, ≥1000 cells/ μL peripheral blood absolute neutrophil count (ANC), and 0% peripheral blood blasts.
Marrow complete remission (MCR): ≤5% myeloblasts and decreased by ≥50% compared to pre-treatment bone marrow blasts, bone marrow morphology not relevant, and peripheral blood (if hematological improvement they will be noted in addition to marrow CR).
Partial remission (PR): previously had ≥5% myeloblasts and now have ≥5% myeloblasts but decreased by ≥50% compared to pre-treatment, bone marrow morphology not relevant, ≥11 g/dl peripheral blood hemoglobin, ≥100x109cells/μL peripheral blood platelets, ≥1000 cells/ μL peripheral blood ANC, and 0% peripheral blood blasts"|Up to 56 weeks (14 cycles of treatment)|8 participants were not evaluable for this outcome measure because they did not complete at least one cycle of therapy.||participants|||Number
831486|NCT01246206|Secondary|Determine Time to Engraftment|Time to engraftment (“PLT20”)|Followed for up to two years post transplant|All paarticipants||days||Full Range|Median
831487|NCT01246206|Secondary|Determine Time to Engraftment|Time to engraftment (“G500”)|Followed for up to two years post transplant|All paarticipants||days||Full Range|Median
831488|NCT01246206|Secondary|Overall Survival at Two Year,||Followed for up to two years post transplant|All participants||percentage of participants||95% Confidence Interval|Number
831489|NCT01246206|Secondary|Estimate Incidence of Chronic GVHD at Two Years|Cumulative Incidence of chronic GVHD with relapse or NRM as competing risks|Followed for up to two years post transplant|All participants||percentage of participants||95% Confidence Interval|Number
831490|NCT01246206|Secondary|Determine Incidence of Opportunistic Infections||Followed for up to two years post transplant|All participants||percentage of participants||95% Confidence Interval|Number
831491|NCT01246206|Primary|Severity of Acute GVHD|Cumulative Incidence of grade III-V acute GVHD with relapse or NRM as competing risks|Assessed first 6 months post transplant|Those participants who contracted Acute GVHD||% of participants with sever aGVHD||95% Confidence Interval|Number
831492|NCT01246206|Primary|Safety Defined by Serious Adverse Events|Counted the number of participants that experienced any type of grade 3 or higher toxicity.|Assessed first 6 months post transplant|||participants|||Number
831493|NCT01246206|Primary|Incidence of Acute GVHD|Cumulative Incidence of grade II-V acute GVHD with relapse or NRM as competing risks|Assessed first 6 months post transplant|All participants||percentage of participants||95% Confidence Interval|Number
831494|NCT01246258|Other Pre-specified|Utricular Centrifugation Test (UCF)|balance assessment|one day|||participants|||Number
831495|NCT01246258|Primary|Vestibular Evoked Myogenic Potentials (VEMPs)|These are the balance tests that specifically assess the otolith organ.|one day|||participants|||Number
831496|NCT01246349|Primary|Child Dietary Self-Efficacy Scale|"A second self-efficacy scale, the Child Dietary Self-Efficacy Scale (CDSS; Parcel et al., 1995) was used to measure participants' confidence in their ability to choose lower fat, lower sodium foods.
The questionnaire is made up of 20 likert items with 3 response options, including not sure, a little sure, and very sure. Each item asks the participant to indicate how sure he/she is that they would make a healthy choice, for example, How sure are you that you could eat cereal instead of a donut? Individual items are scored -1, 0, or 1 and subsequently summed for a total score, with the lowest possible score a -20 and the highest a 20, whereby higher scores signify higher dietary self efficacy."|Baseline, 6 month follow-up|||scores on a scale||Standard Deviation|Mean
831497|NCT01246349|Secondary|Psychological Well-being|Rosenberg Self-Esteem scale, Pediatric Quality of Life Inventory (PEDS QL), Child depression inventory, Adolescent coping (A-COPE)|Change over time from Baseline to 6 months (measured monthly) with a 12 months reassessment||||||
831498|NCT01246349|Secondary|Physiological Outcomes: Waist Circumference|Measurements of waist circumference, an indirect measure of central adiposity (or fatness), were also obtained.|Baseline, 6 month follow-up|||cm||Standard Deviation|Mean
831499|NCT01246349|Secondary|Physiological Outcomes: BMI|The study used a Body Mass Index (BMI) percentile for age as the main indicator of weight-loss. Height and weight was measured by the pediatrician at the treatment site and BMI as well as BMI percentile for age was determined with the use of an age appropriate growth curve chart.|Baseline, 6 month follow-up|||z-score||Standard Deviation|Mean
831500|NCT01246349|Primary|Weight Efficacy Life-style Questionnaire|"A self-efficacy instrument, the Weight Efficacy Life-style Questionnaire (WEL; Clark, Abrams, Niaura, Eaton, & Rossi, 1991) was used to measure participants' beliefs about and confidence in their own ability to make a behavior change, specifically their ability to lose weight.
The questionnaire yields a total score, with higher scores indicating higher levels of health-related self-efficacy, as well as 5 situational sub-scores (negative emotions, availability, social pressure, physical discomfort, and positive activities). Individuals rate statements on a 10-point scale ranging from 0 (not confident) to 9 (very confident).
The WEL is made up of 20 items (4 items per sub-scale) which are summed to obtain a total score, with the lowest total score possible being 0 and the highest 180. Only the total WEL score was used in the study's analyses.
The difference in self-efficacy (WEL) change between treatment and control groups from baseline to a 6 month follow-up was examined."|Baseline, 6 month follow-up|||scores on a scale||Standard Deviation|Mean
831501|NCT01239043|Other Pre-specified|Number of Participants Who Achieved a Four-Fold Rise in Bactericidal Antibody Titers From Baseline After Vaccination With Either Menomune or Menactra Vaccine|Titers of antibodies to serogroups A, C, Y, and W-135 were measured by serum bactericidal assay with baby rabbit complement (SBA-BR).|Day 0 (pre-vaccination) and Day 28 post-vaccination|Antibody titers were assessed in participants who met all inclusion, but no exclusion criteria; received assigned study vaccine; and had serology samples with valid test results (Per-Protocol Population).||Participants|||Number
831502|NCT01239043|Other Pre-specified|Number of Participants With Antibody Titers at ≥ 1:8 for Each of the Vaccine Serogroups Before and After Vaccination With Either Menomune or Menactra Vaccine|Titers of antibodies to vaccine serogroups A, C, Y, and W-135 were measured by serum bactericidal assay with baby rabbit complement (SBA-BR).|Day 0 (pre-vaccination) and Day 28 post-vaccination|Antibody titers were assessed in participants who met all inclusion, but no exclusion criteria; received assigned study vaccine and serology samples with valid test results (Per-Protocol Population).||Participants|||Number
831503|NCT01239043|Other Pre-specified|Geometric Mean Titers of Individual Antibodies to Vaccine Antigens Following Vaccination With Either Menomune or Menactra Vaccine (SBA-BR)|Geometric mean titers (GMTs) of antibodies to serogroups A, C, Y, and W-135 were measured by serum bactericidal assay with baby rabbit complement (SBA-BR).|Day 0 (pre-vaccination) and Day 28 post-vaccination|GMTs were assessed in participants who met all inclusion, but no exclusion criteria; received assigned study vaccine; and had serology samples with valid test results (Per-Protocol Population).||Titers||95% Confidence Interval|Geometric Mean
831504|NCT01239043|Other Pre-specified|Number of Participants Who Achieved a Four-Fold Rise in Bactericidal Antibody Titers From Baseline Following Vaccination With Either Menomune or Menactra Vaccine.|Titers of antibodies to serogroups A, C, Y, and W-135 were measured by serum bactericidal assay with human complement (SBA-HC).|Day 0 (pre-vaccination) and Day 28 post-vaccination|Antibody titers were assessed in participants who met all inclusion, but no exclusion criteria; received assigned study vaccine; and had serology samples with valid test results (Per-Protocol Population).||Participants|||Number
831505|NCT01239043|Other Pre-specified|Summary of Participants Antibody Titers for Each of the Vaccine Serogroups Before and 28 Days After Vaccination With Either Menomune or Menactra Vaccine.|Titers of antibodies to serogroups A, C, Y, and W-135 for each participant were measured by serum bactericidal assay with human complement (SBA-HC).|Day 0 (pre-vaccination) and Day 28 post-vaccination|Antibody titers were assessed in participants who met all inclusion, but no exclusion criteria; received assigned study vaccine; and had serology samples with valid test results (Per-Protocol Population).||Participants|||Number
831506|NCT01239043|Other Pre-specified|Geometric Mean Titers of Individual Antibodies to Vaccine Antigens Following Vaccination With Either Menomune or Menactra Vaccine|Geometric mean titers (GMTs) of antibodies to serogroups A, C, Y, and W-135 were measured by serum bactericidal assay with human complement (SBA-HC).|Day 0 (pre-vaccination) and Day 28 post-vaccination|GMTs were assessed in participants who met all inclusion, but no exclusion criteria; received assigned study vaccine; and had serology samples with valid test results (Per-Protocol Population).||Titers||95% Confidence Interval|Geometric Mean
831507|NCT01239043|Primary|Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Either Menomune or Menactra Vaccine|"Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, Myalgia.
Grade 3 reactions were defined as: Pain, headache, malaise, and myalgia - significant, prevents daily activity; Erythema and swelling - > 100 mm; Fever, temperature of ≥ 39.0ºC or ≥ 102.1ºF."|Day 0 to Day 7 post-vaccination|Solicited reactions were assessed in all subjects who received at a dose of study vaccine, according to the vaccine actually received (Safety Analysis Population).||Participants|||Number
831508|NCT01239056|Secondary|Adverse Events||1 year|||participants|||Number
831509|NCT01239056|Primary|Technical Success of Endoscopic Ultrasound-guided Single-access Pseudocyst Drainage With a Fully Covered Self-expanding Metal Stent ; Anchored With a Double Pigtail Plastic Stent Inserted Through the Metal Stent Lumen|"Technical success was evaluated by the ability to achieved pseudocyst drainage after endoscopically placing a Fully Covered Self-expanding Metal Stent in the pseudocyst .
Technical failure was evaluated by the inability to fully drain the pancreas pseudocyst after endoscopically placing a Fully Covered Self-expanding Mental Stent in the pseudocyst."|baseline|||participants|||Number
831510|NCT01239056|Secondary|Resolution of Pancreatic Pseudocyst After Placement of Fully Covered Self-expanding Metal Stent (CSEMS).||6 to 12 weeks after baseline|||participants|||Number
831511|NCT01239121|Secondary|Medication-related Symptoms|Patient's self-report of medication-related symptoms by telephone questionnaire|Up to 1 month after hospital discharge|"For this outcome 66 and 87 participants unable to be reached by telephone in first and second arms, respectively.
Outcome not ascertained in the third arm because those participants were not hospitalized."||participants|||Number
831512|NCT01239121|Secondary|Adverse Drug Events|Actual harm to patient from hospital medication discrepancies by record review|During hospital stay and up to 1 month after hospital discharge|Outcome not ascertained in the third arm because those participants were not hospitalized.||participants|||Number
831513|NCT01239121|Primary|Transition Drug Risk|Rating of potential for harm to patient from hospital medication discrepancies by record review. Minimum=0 Maximum=no maximum. Higher values represent increased detection of medication discrepancies. Although medication discrepancies are undesirable, increasing their detection might facilitate prevention of adverse drug events.|During hospital stay and up to 1 month after hospital discharge|Outcome not ascertained in the third arm because those participants were not hospitalized.||units: risk-weighted discrepancies||Standard Deviation|Mean
831514|NCT01239212|Secondary|Number of Participants With Adverse Events|Participants' medical records will be reviewed for any adverse effects of the medication seen in the 24 hours after the loading dose.|24 hours after dose||||||
831515|NCT01239212|Secondary|Change in Vital Sign Baseline|Short term treatment-emergent adverse effects of levetiracetam will be measured by change from vital sign baseline in the 24 hours after the dose.|24 hours after loading dose||||||
831516|NCT01239212|Primary|Pharmacokinetic Profile|3 levels for levetiracetam and its metabolite L057 will be drawn: at 5-20 minutes after the dose, 1-2 hours after the dose, and 6-10 hours after the dose. In infants who remain on maintenance doses of the medication, a steady state level will be drawn 4-7 days after the loading dose. Outcome reported is clearance. The median maximum clearance rate was measured in each participant and determined by evaluating the levels of levetiracetam at each time point using MW Pharm.|5-20 minutes after the dose, 1-2 hours after the dose, 6-10 hours after the dose, and possibly 4-7 days after loading dose (if infants remained on maintenance doses)|all participants had adequate levels drawn for analysis||ml/min/kg||Full Range|Median
831517|NCT01239316|Secondary|Pharmacokinetic Parameters of Vismodegib, CSF Penetration|The estimated median of cerebrospinal fluid (CSF) drug penetration is reported when expressed as an AUC ratio of CSF vismodegib to that of unbound drug in plasma.|up to 12 month|The calculation of drug penetration is based on patients who had the course 1 plasma and CSF drug concentration data||penetration rate||Full Range|Median
831566|NCT01246713|Primary|Acetaminophen Metabolites|Area-under-curve from time zero to 8 hours for APAP-cysteinate metabolite. Serum was collected just prior to and at hours 1, 2, 4, 6, and 8 after administration of the APAP dose.|8 hours|||mcg.hr/ml||Standard Error|Mean
831567|NCT01247220|Secondary|Retinal Thickness|central foveal thickness on optical coherence tomography|6 and 12 months|||microns||Standard Deviation|Mean
831518|NCT01239316|Secondary|Duration of Objective Response|The duration of objective response is measured from the initial scan documenting complete or partial response that was subsequently confirmed until the earlier of documented progression or death on study. Duration of objective response is censored at the last tumor assessment date for patients without disease progression who have not died within 30 days of last exposure to study treatment.|From start of treatment up to 2 years|Patient with sustained objective response||months|||Number
831519|NCT01239316|Primary|Pharmacokinetics (Plasma) of GDC-0449|plasma GDC-0449 concentration of day 21 in first course|up to 12 month|Patients who have day 21 plasma GDC-0449 concentration data available||uM||Full Range|Median
831520|NCT01239316|Secondary|Progression-free Survival|Progression-free survival (PFS) is measured from the date of initial treatment with GDC-0449 until the earliest of progression or death on study. PFS is censored at the last tumor assessment date for patients without disease progression who have not died within 30 days of last exposure to study treatment. Kaplan-Meier method is used to estimate the progression-free survival.|From start of treatment up to 2 years|||months||95% Confidence Interval|Median
831521|NCT01239316|Primary|Objective Response (CR+PR) Sustained for ≥ 8 Weeks|Objective response is either a complete response or a partial response sustained for 8 weeks in a patient. The objective response rate will be reported separately for patients of each stratum. CR is complete disappearance of all enhancing tumor. PR is >= 50% reduction in tumor size.|Up to 12 months|||participants|||Number
831522|NCT01239342|Secondary|Time to Failure (TTF)|TTF defined as Time interval between the date of treatment and the date of disease progression, date of death, date of treatment discontinuation due to severe toxicity or last follow-up date.|Time interval between the date of treatment and the date of disease progression, date of death, date of treatment discontinuation due to severe toxicity or last follow-up date, assessed up to 5 years|No participants analyzed. Data not collected.|||||
831523|NCT01239342|Secondary|Median Overall Survival (OS) in Months|Overall survival reported in months as time interval between the date of treatment and the date of death or last follow-up.|Time interval between the date of treatment and the date of death or last follow-up, assessed up to 5 years|||Months||Full Range|Median
831524|NCT01239342|Secondary|Overall Response Rate (ORR) Defined as Complete Response (CR) + Partial Response (PR)|Response for CR + PR defined by RECIST version 1.1. Repeat radiologic studies to evaluate disease progression or response (in accordance with restaging of disease) every 8 weeks. Complete Response (CR): Disappearance all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): >30% decrease in sum diameters of target lesions, reference baseline sum diameters. Progressive Disease (PD): >20% increase in sum diameters of target lesions, reference smallest sum on study (includes baseline sum if is smallest on study). In addition to relative increase of 20%, sum must demonstrate absolute increase >5 mm. (Note: appearance 1/+ new lesions considered progressions). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum diameters.|Up to 5 years|One participant in each group left study before restaging therefore are excluded from response outcome analysis.||percentage of participants|||Number
831525|NCT01239342|Secondary|Summary of Selected Toxicities Grade 3 or Greater Toxicity Based on the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0|Adverse Events (AEs) list of reported events with associated intervention agent in a uniform presentation of events. The method of Thall, Simon and Estey (1995, 1996) was used to collect study participants’ safety data summarized by treatment arm, category, severity and relevance. Comprehensive listing of AEs collected on study can be found in Adverse Event section separated by severity, Serious and Other AEs and represented by treatment arm, organ system-category within defined severity.|Up to 5 years|||Toxicities|||Number
831526|NCT01239342|Secondary|Clinical Benefit Defined as Number of Participants With Complete Response (CR) + Partial Response (PR) + Stable Disease (SD)|Clinical benefit defined as participants' with CR+PR+SD assessed using Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. Repeat radiologic studies to evaluate disease progression or response (in accordance with restaging of disease) every 8 weeks. Complete Response (CR): Disappearance all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): >30% decrease in sum diameters of target lesions, reference baseline sum diameters. Progressive Disease (PD): >20% increase in sum diameters of target lesions, reference smallest sum on study (includes baseline sum if is smallest on study). In addition to relative increase of 20%, sum must demonstrate absolute increase >5 mm. (Note: appearance 1/+ new lesions considered progressions). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum diameters.|Up to 5 years|One participant in each group left study before restaging therefore are excluded from outcome analysis.||Participants|||Count of Participants
831527|NCT01239342|Primary|Median Progression Free Survival (PFS) in Months|PFS defined as Time interval between date of treatment and date of disease progression, date of death or last follow-up date, whichever occurs first. Progression defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a nontarget lesion, or the appearance of new lesions.|Time interval between date of treatment and date of disease progression, date of death or last follow-up date, whichever occurs first, assessed up to 5 years|One participant in each group left study before restaging therefore are excluded from response outcome analysis.||Months||95% Confidence Interval|Median
831528|NCT01239355|Secondary|Overall Survival|Survival will be estimated by the product-limit (Kaplan-Meier) estimator.|Until death, up to 26 months|||Months||95% Confidence Interval|Median
831529|NCT01239355|Secondary|Objective Response|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR|Evaluated for response every 2 cycles (8 weeks) with confirmatory evaluation at least 4 weeks following initial documentation of objective response, up to 26 months|||participants|||Number
831568|NCT01247220|Secondary|Number of Ranibizumab Injections|Number of ranibizumab injections needed by decreased visual acuity and/or increasing retinal thickness in second six months of observation period|12 months|||injections||Full Range|Mean
831569|NCT01247220|Primary|Visual Acuity|ETDRS visual acuity|6 and 12 months|||letters on ETDRS Visual Acuity Chart||Standard Deviation|Mean
831530|NCT01239355|Primary|Progression-free Survival|Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions (the sum must also demonstrate an absolute increase of at least 5 mm), or a measurable increase in a non-target lesion, or the appearance of new lesions.|Until disease progression or death, up to 26 months|||Months||95% Confidence Interval|Median
831531|NCT01239381|Secondary|Median Survival Among Participants With Colorectal Cancer|The median amount of time participants survived from the start of treatment, among the participants with colorectal cancer.|2 years|The 35 participants with colorectal cancer as the primary cancer.||Months||95% Confidence Interval|Median
831532|NCT01239381|Secondary|1 Year Local Control Rate Among Participants With Colorectal Cancer|The percentage of participants with local control at one year among the participants with colorectal cancer as the primary cancer.|1 year|Participants with colorectal cancer||percentage of participants|||Number
831533|NCT01239381|Secondary|2-year Local Control Rate|The percentage of participants with local control 2 years after the start of study treatment.|2 years|||percentage of participants||95% Confidence Interval|Number
831534|NCT01239381|Secondary|Median Progression Free Survival|The median amount of time participants survived without cancer progression following the start of study treatment. Progression was assessed using RECIST v1.0. Progressive Disease (PD) is defined as at least a 20% increase in the Longest Diameter (LD) of the lesion, taken as the reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|1 years|||Months||95% Confidence Interval|Median
831535|NCT01239381|Secondary|Median Overall Survival|The median overall survival (in months) of participants as measured from the start of treatment.|2 years|||Months||95% Confidence Interval|Median
831536|NCT01239381|Secondary|Median Follow-up Time|The median follow-up time among the 39 participants still alive at the time of analysis, measured from the start of treatment until the time of analysis.|1 year|the 39 participants still alive at the time of analysis||Months||95% Confidence Interval|Median
831537|NCT01239381|Primary|Local Control Rate|"The percentage of participants with local control at primary tumor site at one year. Local is evaluated using Response Evaluation Criteria In Solid Tumors (RECIST). Local control is defined as achieving either Complete response (CR), Partial Response (PR), or Stable Disease (SD).
(CR): Disappearance of entire lesion, with no additional evidence of disease.
(PR): At least a 30% decrease in the (sum of) the longest diameter (LD) of the primary lesion, taken as reference the baseline sum LD.
(SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started."|1 year|The 90 participants that started study treatment||percentage of participants|||Number
831542|NCT01239511|Secondary|Dose-response Relationship of Three Different Dose Levels of STA-2 Versus Placebo Control in Change in Total Exercise Time.||6 weeks||||||
831543|NCT01239511|Secondary|Change in Lipid Profiles (HDL-C, LDL-C, Total Cholesterol, Triglyceride) From Baseline to All Visits||6 weeks||||||
831544|NCT01239511|Secondary|Change in Pharmacological Parameters (Oxidized-LDL), Isoprostane and High-sensitivity Hs-CRP From Baseline to All Visits||6 weeks||||||
831545|NCT01239511|Secondary|Change in Consumption of Short-acting Nitrates From Baseline to All Visits||6 weeks||||||
831546|NCT01239511|Secondary|Changes in Angina Frequency in Subject's Diary From Baseline to All Visits||6 weeks||||||
831547|NCT01239511|Secondary|Changes in Time to Maximum ST-segment Depression During ETT From Baseline to the Final Visit||6 weeks||||||
831548|NCT01239511|Secondary|Changes in Time to 1mm ST-segment Depression During ETT From Baseline to Final Visit||6 weeks||||||
831549|NCT01239511|Secondary|Change in Time to Onset of Angina From Baseline to the Final Visit||6 weeks||||||
831550|NCT01239511|Primary|Change in Total Exercise Time (Seconds)|the time difference of total exercise time from V2 to V5 compare to placebo|6 weeks after the first exercise tolerance testing is conducted|ITT (intend-to-treat) population will be used for analysis||second||Standard Deviation|Least Squares Mean
831551|NCT01246401|Secondary|ART Adherence for 4 or More Injections XR-NTX Versus Placebo and 3 or Less Injections of XR-NTX|The arm/group number of the participants vary from the primary outcome because this is a treatment effect analysis. All client with missing data at 6 months were considered as failure - meaning - they had less than 100% ART adherence.|6 months|All client with missing data at 6 months were considered as failure - meaning - they had less than 100% ART adherence.||Participants|||Count of Participants
831570|NCT01247272|Secondary|AUC0-inf of Norfluoxetine.|Bioequivalence based on Norfluoxetine AUC0-inf (area under the concentration-time curve from time zero to infinity).|Blood samples collected over a 25 day period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
831552|NCT01246401|Secondary|Opioid Abstinence at 6 Months for Those With More Than 4 Injections|Based on self reported opioids (heroin) use. All participants receiving Placebo as well as participants who received 3 or less XR-NTX injections were compared to those who receive 4 or more XR-NTX injection.|6 months|Collected via Time Line Fall Back (TLFB). Total N analyzed is 74. 12 of the clients had initial or some TLFB data indicating relapse but were counted as lost at 6 months for outcome 4. 19 Clients did not have TLFB data or if they did within 6 month it did not indicate any relapse. These were treated as missing and not included in analysis.||Participants|||Count of Participants
831553|NCT01246401|Secondary|Participants With Opiate Abstinence Via By Doing Urine Toxicology Test|Percent of subjects with no opiate use at 6 month. Missing data was treated as failure (opiate positive).|6 month|||Participants|||Count of Participants
831554|NCT01246401|Secondary|Antiretroviral Therapy (ART) Adherence 100%|Number of subjects with 100% adherence at 6 months measured using Visual Analogue Scale: 0% to 100%|6 months|56 participants with missing data were considered as failure - meaning - with adherence less than 100%, and included into the analysis.||Participants|||Count of Participants
831555|NCT01246401|Secondary|Craving for Opioids|Craving at baseline compared to 6 month. This is assessed through a self report scale rated 0 to 10; 0 meaning not craving and 10 meaning highest craving. Change in craving score was categorized as 1)no change between baseline and 6 month; 2)increased craving - baseline craving was reported lower than at 6 month; 3)decreased craving - baseline craving was reported higher than 6 month craving.|6 months|Data available at 6 month determined who was included into the analysis. In this case a total of 47 data points (those with both baseline and 6 month data points) were included into the analysis (32 Extended-Release Naltrexone and 15 Placebo).||Participants|||Count of Participants
831556|NCT01246401|Secondary|Addiction Severity|"The Addiction Severity Index (ASI) questionnaire will be used to assess addiction severity. The ASI composite scoreprovides reliable and valid measure of patient status in a particular module of interest which can then be usecompared at the beginning of treatment to the evaluation endpoint to note the improvement or lack thereof. In this assessment the drug composite score was calculated using algorithm by Treatment Research Institute. If the score increases then it shows increase in severity where as if it decreases then it shows decrease in severity for that measured module. The scale ranges from 0 to 1.
The mean composite scores for drug use from baseline to 6 months were compared using Nonparametric test."|baseline, and 6 months|An additional subject's data from the experimental group was not collected at baseline. For the 6 months data, the total number of participants with completed assessment used for the analysis was 46 (31 in XR-NTX group and 15 in Placebo group).||units on a scale||Standard Deviation|Mean
831557|NCT01246401|Secondary|Time to Opioid Relapse or End of Intervention|Measuring days to first relapse based on self reported opioids (heroin) use within the 6 month (180 days) intervention period. If participants had no follow-up visits, and thus no self reported opiate use, they were treated as missing. Those who did not relapse within the 6 month intervention period were treated as having 180 days until relapse.|6 months|Data collected via Time Line Fall Back (TLFB). 15 in XR-NTX group and 4 in Placebo did not have data because of attrition - treated as missing. An additional 19 people in the treatment arm and 9 in placebo filled out the TLFB at 9 or 12 months, and this data was used to fill in missing information.||days||Full Range|Median
831558|NCT01246401|Secondary|CD4 Cell Count (Cells/mL)|Baseline labs will be drawn while subject is in prison, one to three months prior to release. Additional labs will be drawn every 3 months for 1 year to monitor changes in CD4 levels.|Baseline and 6 months|Data was collected via labs. At month 6, due to attrition, data was only available for a total of 46 subjects. These include, 14 in Placebo and 32 in Extended-Release Naltrexone. The mean and STD are presented below.||cells/ml||Standard Deviation|Mean
831559|NCT01246401|Secondary|Particpants Who Had Undetectable HIV-1 RNA Levels at Less Than 50 Copies/mL|Baseline labs will be drawn while subject is in prison, one to three months prior to release. Additionally, labs will be drawn every 3 months for 1 year to monitor changes in HIV-1 RNA levels. Treatment time period was the first 6 months where the primary outcome data will be based on.|6 months|A total of 80 participants had viral load data at 6 months (56 in XR-NTX group and 24 in Placebo group). The remaining 13 participants (10 in XR-NTX group and 3 in Placebo group) with missing viral load data at 6 months were considered as failure - meaning - having a viral load of 400 or more. Thus included into the final analysis.||Participants|||Count of Participants
831560|NCT01246401|Primary|Participants Who Had Undetectable HIV-1 RNA Levels at Less Than 400 Copies/mL at Six Month|Baseline labs will be drawn while subject is in prison, one to three months prior to release. Additionally, labs will be drawn every 3 months for 1 year to monitor changes in HIV-1 RNA levels. Treatment time period was the first 6 months where the primary outcome data will be based on.|6 months|A total of 80 participants had viral load data at 6 months (56 in XR-NTX group and 24 in Placebo group). The remaining 13 participants (10 in XR-NTX group and 3 in Placebo group) with missing viral load data at 6 months were considered as failure - meaning - having a viral load of 400 or more. Thus included into the final analysis.||Participants|||Count of Participants
831561|NCT01246479|Secondary|Rate of Subjects With AEs and Medically Attended AEs up to Months 12, 24 and 36 After the First IC51 Vaccination (in Study IC51-322). Severity, Duration and Relationship to Vaccinations.|Rate of subjects with AEs and medically attended AEs up to Months 12, 24 and 36 after the first IC51 vaccination (in study IC51-322). Severity, duration and relationship to vaccinations.|Months 12, 24 and 36||||||
831562|NCT01246479|Secondary|Rate of Subjects With SAEs Following Immunization up to Months 12, 24 and 36 After the First IC51 Vaccination (in Study IC51-322)|Rate of subjects with SAEs following immunization up to Months 12, 24 and 36 after the first IC51 vaccination (in study IC51-322)|Months 12, 24 and 36||||||
831563|NCT01246479|Secondary|GMTs and Rate of Subjects With PRNT50 Titers of ≥ 1:10 at Months 24 and 36 After the First IC51 Vaccination (in Study IC51-322)|GMTs and rate of subjects with PRNT50 titers of ≥ 1:10 at Months 24 and 36 after the first IC51 vaccination (in study IC51-322)|Month 24, 36||||||
831564|NCT01246479|Secondary|GMT for JEV Neutralizing Antibodies Measured Using the PRNT at Month 12 After the First IC51 Vaccination (in Study IC51-322)|GMT for JEV neutralizing antibodies measured using the PRNT at Month 12 after the first IC51 vaccination (in study IC51-322)|Month 12||||||
831571|NCT01247272|Secondary|AUC0-t of Norfluoxetine.|Informational comparison of AUC0-t values for the metabolite Norfluoxetine.|Blood samples collected over a 25 day period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
831574|NCT01247272|Primary|AUC0-t of Fluoxetine.|Bioequivalence based on Fluoxetine AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).|Blood samples collected over a 25 day period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
831575|NCT01247272|Primary|Cmax of Fluoxetine.|Bioequivalence based on Fluoxetine Cmax (maximum observed concentration of drug substance in plasma).|Blood samples collected over a 25 day period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
831576|NCT01247285|Secondary|AUC0-inf of Norfluoxetine.|Informational comparison of AUC0-inf values for the metabolite Norfluoxetine.|Blood samples collected over a 25 day period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
831577|NCT01247285|Secondary|AUC0-t of Norfluoxetine.|Informational comparison of AUC0-t values for the metabolite Norfluoxetine.|Blood samples collected over a 25 day period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
831578|NCT01247285|Secondary|Cmax of Norfluoxetine.|Informational comparison of Cmax values for the metabolite Norfluoxetine.|Blood samples collected over a 25 day period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
831579|NCT01247285|Primary|AUC0-inf of Fluoxetine.|Bioequivalence based on Fluoxetine AUC0-inf (area under the concentration-time curve from time zero to infinity).|Blood samples collected over a 25 day period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
831580|NCT01247285|Primary|AUC0-t of Fluoxetine.|Bioequivalence based on Fluoxetine AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).|Blood samples collected over a 25 day period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
831581|NCT01247285|Primary|Cmax of Fluoxetine.|Bioequivalence based on Fluoxetine Cmax (maximum observed concentration of drug substance in plasma).|Blood samples collected over a 25 day period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
831582|NCT01247298|Secondary|Percentage of Participants With Local Failure Patterns|Assess local failure patterns of patients treated with TACE & SBRT. This is assessed by the percentage of patients where recurrence occurred|Baseline up to 2 years after treatment completed|||percentage of participants|||Number
831583|NCT01247298|Secondary|Percentage of Participants With Overall Survival|Assess overall survival (OS) of patients treated with TACE & SBRT. This is assessed by the length of time from either the date of diagnosis or the start of treatment that patients diagnosed with the disease are still alive.|up to 2 years after treatment completed|Survival analysis was performed for all patients.||percentage of participants|||Number
831584|NCT01247298|Primary|Local Recurrence Rate|Evaluate the number of patients with local recurrence. Patient will be asked to visit their study doctor for follow-up exams every 3 months for 2 years while participating in this study.Patient will be asked to visit their study doctor for follow-up exams and imaging (CT or MRI) every 3 months. This will be measured by number of patients with recurrence on their follow-up imaging.|Baseline to up to 2 years after treatment completed|||participants|||Number
831585|NCT01247298|Primary|Median Progression Free Survival (PFS) Treated With a Combination of TACE & SBRT.|Patient will be asked to visit their study doctor for follow-up exams and imaging (CT or MRI) every 3 months until complete response or progression. This will be measured by tumor progression and/or death on follow-up imaging from completion of treatment.|Baseline to up to 2 years after treatment completed|||months||95% Confidence Interval|Median
831586|NCT01247298|Primary|Safety of a Combination Therapy|Evaluate the safety of a combination of TACE and high dose SBRT. Patients were evaluated for toxicity during their follow-up exams every 3 months for 2 years while participating in this study. Patients were also instructed to notify the PI between visits if any related toxicity issues occurred.|Baseline to 45 day after completing combination treatment.|All enrolled patients were analyzed.||participants|||Number
831617|NCT01247428|Secondary|Percentage of Participants Experiencing Major Adverse Cardiac Events (MACE)|Major Adverse Cardiac Events (MACE) defined as death, myocardial infarction (Q-wave and non-Q-wave) and target vessel revascularization (TVR)|240 days|||percentage of participants||95% Confidence Interval|Number
831618|NCT01247428|Primary|Angiographic In-Stent Late Lumen Loss|In-stent late lumen loss as measured by the angiographic core laboratory as the difference between the post-procedure minimal lumen diameters (MLD) in the treated segment (stented region) minus the MLD in the same region at follow-up.|8 months|Last observation used, such that patients (n=10) in the 8 month analysis is reported.||mm||Standard Deviation|Mean
831619|NCT01247571|Secondary|Overall Survival|The observed length of life from entry into the study to death or the date of last contact.|Time from start of treatment to time of death or the date of last contact, assessed up to 5 years|Eligible and treated patients||months||95% Confidence Interval|Median
831601|NCT01247428|Secondary|OCT Evaluation: % Stent Strut Uncovered|% stent strut uncovered is defined as the ratio of uncovered struts to total struts in all cross-sections.|18 M|27 out of 30 patients analyzed||percentage of struts uncovered||Full Range|Median
831602|NCT01247428|Secondary|Optical Coherence Tomography (OCT) Evaluation: % Stent Strut Uncovered|% stent strut uncovered is defined as the ratio of uncovered struts to total struts in all cross-sections.|8 months|Patients evaluated at 4(n=10), 6(n=10) and 8(n=10) months. Only 9/30 patients had evaluable OCT at the 8 month timeframe.||percentage of struts uncovered||Full Range|Median
831603|NCT01247428|Secondary|IVUS Evaluation: % Neointimal Volume Obstruction|% neointimal volume obstruction is defined as the neointimal volume divided by stent volume.|18 months|20 out of 30 participants analyzed||percentage of volume obstruction||Standard Deviation|Mean
831604|NCT01247428|Secondary|Intravascular Ultrasound (IVUS) Evaluation: % Neointimal Volume Obstruction|% neointimal volume obstruction is defined as the neointimal volume divided by stent volume.|8 months|Patients evaluated at 4(n=10), 6(n=10) and 8(n=10) months. Only 25/30 patients had evaluable IVUS data.||percentage of volume obstruction||Standard Deviation|Mean
831605|NCT01247428|Secondary|Angiographic Evaluation: In-stent Binary Restenosis|Binary Restenosis is defined as ≥50% luminal narrowing at follow-up angiography.|18 months|Population includes participants from whom data was collected.||participants|||Number
831606|NCT01247428|Secondary|Angiographic Evaluation: In-stent Binary Restenosis|Binary Restenosis is defined as ≥50% luminal narrowing at follow-up angiography.|4 months, 6 months, 8 months|Patients evaluated at 4(n=10), 6(n=10) and 8(n=10) months.||participants|||Number
831607|NCT01247428|Secondary|Stent Thrombosis|The presence of an intracoronary thrombus that originates in the stent or in the segments 5 mm proximal or distal to the stent post-procedure|240 days|||percentage of participants||95% Confidence Interval|Number
831608|NCT01247428|Secondary|Target Lesion Failure (TLF)|"Target lesion failure (TLF) is defined as the composite endpoint of:
cardiac death,
target-lesion myocardial infarction (Q wave or non-Q wave), and
clinically indicated target lesion revascularization"|240 days|||percentage of participants||95% Confidence Interval|Number
831609|NCT01247428|Secondary|Target Vessel Failure (TVF)|"Target vessel failure (TVF) is defined as the composite endpoint of:
cardiac death,
target-vessel myocardial infarction (Q wave or non-Q wave), and
clinically indicated target vessel revascularization"|240 days|||percentage of participants||95% Confidence Interval|Number
831610|NCT01247428|Secondary|Clinically-driven Target Vessel Revascularization (TVR) Rates|"A revascularization is considered clinically driven if angiography at follow-up shows a percent diameter stenosis ≥ 50% (Angiographic Core Laboratory QCA assessment) and if one of the following occurs:
A positive history of recurrent angina pectoris, presumably related to the target vessel;
Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;
Abnormal results of any invasive functional diagnostic test (e.g., Doppler flow velocity reserve, fractional flow reserve);
A target vessel revascularization (TVR) with a diameter stenosis ≥ 70% even in the absence of the above-mentioned ischemic signs or symptoms."|240 days|||percentage of participants||95% Confidence Interval|Number
831611|NCT01247428|Secondary|Clinically-driven Target Lesion Revascularization (TLR) Rates|"A revascularization is considered clinically driven if angiography at follow-up shows a percent diameter stenosis ≥ 50% (Angiographic Core Laboratory QCA assessment) and if one of the following occurs:
A positive history of recurrent angina pectoris, presumably related to the target vessel;
Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;
Abnormal results of any invasive functional diagnostic test (e.g., Doppler flow velocity reserve, fractional flow reserve);
A target lesion revascularization (TLR) with a diameter stenosis ≥ 70% even in the absence of the above-mentioned ischemic signs or symptoms."|240 days|||percentage of participants||95% Confidence Interval|Number
831612|NCT01247428|Secondary|Total Myocardial Infarction (MI)|"Q-wave MI (QWMI): requires one of the following criteria: the development of new abnormal Q waves in ≥2 contiguous ECG leads not present on the patient's baseline (i.e., before intervention) in association with a >2x upper limit normal elevation of creatine kinase (CK) levels. In the absence of ECG data, the clinical events committee may adjudicate a Q-wave MI based on the clinical scenario and appropriate cardiac enzyme data; chest pain or other acute symptoms consistent with myocardial ischemia and new pathological Q waves in ≥2 contiguous ECG leads in the absence of timely cardiac enzyme data.
Non-Q-wave MI (NQWMI): the elevation of CK levels (≥2 times ULN) with elevated CK-MB enzyme levels in the absence of new pathologic Q waves."|240 days|||percentage of participants||95% Confidence Interval|Number
831613|NCT01247428|Secondary|Total Mortality|Total mortality (cardiac and non-cardiac)|240 days|||percentage of participants||95% Confidence Interval|Number
831614|NCT01247428|Secondary|Procedural Success|Achievement of a final in-stent residual diameter stenosis of <50% (by QCA) using the assigned device (including any adjunctive devices) without cardiac death, Myocardial infarction (MI) or repeat revascularization of the target lesion pre-hospital discharge|8 hours|||percentage of participants||95% Confidence Interval|Number
831620|NCT01247571|Secondary|Progression-free Survival|Progression-free survival is the period from study entry until disease progression, death or date of last contact|From start of treatment to time of progression or death, assessed up to 5 years|Eligible and Treated Patients||months||95% Confidence Interval|Median
831621|NCT01247571|Primary|Number of Patients With Grade 3 or Higher Adverse Events|Grade 3 or higher adverse events were graded by CTCAE v4.|Every cycle while on treatment|Eligible and Treated Patients||participants|||Number
831622|NCT01247571|Primary|Percentage of Participants With Progression-free Survival (PFS) at 6 Months|Progression-free survival is the period from study entry until disease progression, death or date of last contact. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as a 20 % increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|6 months|Eligible and treated patients||percentage of participants||90% Confidence Interval|Number
831623|NCT01247571|Primary|Objective Tumor Response (Complete or Partial)|Complete and Partial Tumor Response by RECIST 1.0. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|CT scan or MRI if used to follow lesion(s) for measurable disease every other cycle for the first 6 mnths; then every 3 mnths thereafter until dx progression is confirmed; also repeat any other time clinically indicated, assessed up to 6 months.|Eligible and Treated Patients||percentage of participants||90% Confidence Interval|Number
831624|NCT01247675|Secondary|Emax of IGF-I|"As part of the following endpoint:
Pharmacodynamic (PD) response of serum Insulin-like Growth Factor-I (IGF-I) from ACP-001 treated dose groups compared to the PD response of IGF-I from the daily Omnitrope treated group.
Emax (maximum observed response) values at Week 4"|Days 22 to 29|Pharmacokinetic and pharmacodynamic analysis was performed on all patients who had at least one measurement of the primary variable and who had attended the Day 28 study visit. Two patients in Cohort 2 (ACP-001, 0.04 mg hGH/kg/wk) were withdrawn from the study before Day 28 and were therefore excluded from the analysis.||ng/mL||Standard Deviation|Mean
831625|NCT01247675|Secondary|Cmax of hGH|"As part of the following endpoint:
Pharmacokinetic (PK) profile of serum human Growth Hormone (hGH) from ACP-001 treated dose groups compared to the PK profile of hGH from the daily Omnitrope treated group.
Cmax (maximum value of concentration) values at Week 4"|Days 22 to 29|Pharmacokinetic and pharmacodynamic analysis was performed on all patients who had at least one measurement of the primary variable and who had attended the Day 28 study visit. Two patients in Cohort 2 (ACP-001, 0.04 mg hGH/kg/wk) were withdrawn from the study before Day 28 and were therefore excluded from the analysis.||ng/mL||Standard Deviation|Mean
831626|NCT01247675|Primary|Incidence of Treatment Emergent Anti-hGH Binding Antibody Formation|Number of subjects with treatment emergent anti-hGH binding antibodies|Start of study treatment through Day 42|All patients who were randomized and received at least one dose of test product were included in the Safety analysis.||Participants|||Number
831627|NCT01247675|Primary|Number of Subjects Reporting Local Tolerability Events (Assessed by the Patient and Investigator)|Assessment of local tolerability was performed by examining injection sites by the investigator during study visits, and on the basis of records in the Patient Diary. Assessments included erythema, swelling, or pain.|Start of study treatment through Week 4|All patients who were randomized and received at least one dose of test product were included in the Safety analysis.||Number of subjects with any symptom|||Number
831628|NCT01247922|Secondary|Median Treatment Duration||From first dose of study drug up to last dose of study drug (The mean treatment duration was 170.5 days)|SAF||days||Full Range|Median
831629|NCT01247922|Secondary|Best Overall Response|Best overall response was derived from an integrated clinical assessment by the study investigator as per institutional standards. This included radiographic assessments deemed appropriate by the investigator in the normal care of the patient. A determination of best overall response at the end of study treatment (complete response, partial response, minor response or stable disease) was only made if (1) any disease-related neurologic symptoms were stable or improving over the interval of the radiographic assessment and (2) corticosteroid dosing for the control of tumor-related signs/symptoms was stable or decreasing.If the investigator deems that a radiographic assessment is not needed, then evidence of clinical improvement may be used to determine best response provided that corticosteroid dosing for tumor-related signs/symptoms is stable or decreasing.|End of treatment (The mean treatment duration was 170.5 days.)|SAF||participants|||Number
831630|NCT01247922|Primary|Safety Assessed Through Evaluation of Physical Examinations, Vital Signs, Clinical Laboratory Tests, and Adverse Events (AEs)|Safety is monitored through AEs, which includes abnormal or clinically significant vital sign assessments, laboratory test, physical examination findings associated with signs and/or symptoms requiring withdrawal, dose modification or medical intervention. A treatment-emergent adverse event (TEAE) was defined as an adverse event observed after starting administration of the study drug. An AE was considered serious (SAE) if it resulted in death, a life-threatening situation, inpatient hospitalization or prolongation of an existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of a patient who received study drug or other important medical events.|From first dose of study drug to 30 days after last dose of study drug (The mean treatment duration was 170.5 days)|The analysis population is the Safety Analysis Set (SAF) consisted of all enrolled patients who received at least 1 dose of study drug.||participants|||Number
831631|NCT01247974|Primary|Primary Effectiveness Endpoint|Rate of new onset postoperative atrial fibrillation during the first seven days postoperatively or prior to hospital discharge, whichever was sooner.|7 days postoperatively or hospital discharge, whichever is sooner|Primary analysis was based upon the ITT population using multiple imputation to impute missing values. The ITT population was defined as all subjects who provided informed consent and were randomized in the trial.||percentage of participants|||Number
831632|NCT01247974|Primary|Primary Safety Endpoint|"A composite endpoint consisting of the following procedure- related serious adverse events occurring within 30 days postprocedure:
Death
Myocardial Infarction (MI)
Stroke
Mediastinal Reoperation
Percutaneous Coronary Intervention (PCI)"|30 days postprocedure|Performed with the FAS population using multiple imputation methods to impute values for missing or incomplete data. FAS population was defined as subjects in the ITT population who had CABG surgery and received their assigned treatment.||percentage of participants|||Number
831633|NCT01248013|Primary|Percentage of Patients With Significant Reduction in Their IBS Symptom Severity Score One Year After Completion of Therapy.|The IBS Symptom Severity Scale has four components, severity of abdominal pain, number of days with pain in past 10 days, abdominal distension, bowel habit and interference with life in general. Maximum score is 500, minimum score is 0. The lower the score, the lower the symptom severity. Participants are considered clinically improved if they have a reduction in score of 50 points or greater.|One year after termination of treatment|||percentage of participants|||Number
831634|NCT01248013|Secondary|Outcome Predictors|to determine whether relationship quality, or attribution of symptoms to physical or emotional causation correlated with result|one year||||||
831635|NCT01248013|Primary|Effectiveness of Group Hypnotherapy in Irritable Bowel Syndrome|assessed by symptom severity scale given before treatment began and after 7 bi-weekly sessions, at 3 months, 6 months and 12 months|one year||||||
831636|NCT01248065|Secondary|Exacerbations|Outcome defined as number of exacerbations per person-year.|Overall exacerbation rate during 28-week trial|||Exacerbations/person-year||95% Confidence Interval|Number
831637|NCT01248065|Secondary|Lung Function Change From Baseline|FEV1 (liters) and methacholine PC20 will be evaluated. Changes are measured as 28 weeks minus baseline.|Change is measured as value at 28 weeks minus baseline value.|||Liters||95% Confidence Interval|Least Squares Mean
831638|NCT01248065|Primary|Treatment Failure|Treatment failure is a well-defined asthma outcome reflecting overall asthma control that has been used previously in multiple clinical trials. Treatment failure as defined in the current proposal and prior trials is consistent with the American Thoracic Society (ATS)/European Respiratory Society(ERS) definition of a moderate exacerbation - a deterioration in symptoms and/or lung function with increased rescue bronchodilator use that lasts 2 days or more. The percentages of participants experiencing a treatment failure are Kaplan-Meier estimates of failure rate.|Twenty-eight week intervention period from randomization until end of trial.|||Percentage of participants||95% Confidence Interval|Number
831639|NCT01248130|Primary|Change in NIMH Clinical Global Impression Scale for Pervasive Developmental Disorders (CGI-PDD) Improvement Scores||weekly||||||
831640|NCT01248130|Primary|Change in Social Responsiveness Scale (SRS) Total Raw Score|Change in SRS Total Raw Score|pre-treatment, 6 weeks, post-treatment (12 weeks)||||||
831641|NCT01248221|Secondary|Gastric Emptying at 60, 120, and 240 Minutes Measured by 13C Spirulina Gastric Emptying Breath Test (GEBT)|A multiple linear regression model approach was used to estimate gastric emptying based on the breath test samples at each time point. Gastric emptying (GE) metric is the proportion of tracer emptied from the stomach at time, t.|60, 120, and 240 minutes after ingestion of standard meal|||proportion of tracer||Standard Deviation|Mean
831642|NCT01248221|Secondary|Gastric Emptying at 60, 120, and 240 Minutes Measured by Scintigraphy|The scintigraphic gastric emptying (GE) metric is the proportion of tracer emptied from the stomach at time, t.|60, 120, and 240 minutes after ingestion of standard meal|||proportion of tracer||Standard Deviation|Mean
831643|NCT01248221|Primary|Gastric Emptying Half Time Measured by 13C Spirulina Gastric Emptying Breath Test (GEBT)|Gastric emptying half time is the time for half of the ingested solids to leave the stomach. This value was measured by the 13C spirulina GEBT.|4 hours after ingestion of standard meal|||minutes||Standard Deviation|Mean
831644|NCT01248221|Primary|Gastric Emptying Half Time Measured by Scintigraphy|Gastric emptying half time is the time for half of the ingested solids to leave the stomach. This value was measured by standard 99m Tc scintigraphy.|4 hours after ingestion of standard meal|||minutes||Standard Deviation|Mean
831645|NCT01248364|Secondary|Change From Baseline in Rate of Endogenous Glucose Production: iAUC 5h, at Day 28|"Change from baseline in the incremental area under the curve of endogenous glucose production from 0 to 5 hours (EGP iAUC 5h), defined as the area under the curve of timepoints 0 to 5 hours after meal reduced by the pre-meal endogenous glucose production at 0 hour.
Note, healthy subjects only received a single dose of empa so assessments at day 28 are not applicable."|0 minutes (min), 15min, 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 4h 30min and 5h after drug administration at baseline and day 28|Treated set (OR) for patients who completed the day 28 visit||g||Standard Error|Least Squares Mean
831646|NCT01248364|Secondary|Change From Baseline in Rate of Endogenous Glucose Production: iAUC 5h, at Day 1|Change from baseline in the incremental area under the curve of endogenous glucose production from 0 to 5 hours (EGP iAUC 5h), defined as the area under the curve of timepoints 0 to 5 hours after meal reduced by the pre-meal endogenous glucose production at 0 hour.|0 minutes (min), 15min, 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 4h 30min and 5h after drug administration at baseline and day 1|Treated set (OR)||g||Standard Error|Least Squares Mean
831647|NCT01248364|Secondary|Change From Baseline in Rate of Endogenous Glucose Production: AUC 5h, at Day 28|"Change from baseline in the area under the curve of endogenous glucose production (EGP) from 0 to 5 hours (EGP AUC 5h) after meal.
Note, healthy subjects only received a single dose of empa so assessments at day 28 are not applicable."|0 minutes (min), 15min, 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 4h 30min and 5h after meal at baseline and day 28|Treated set (OR) for patients who completed the day 28 visit||g||Standard Error|Least Squares Mean
831648|NCT01248364|Primary|Change From Baseline in Glucose Metabolism (Pre-meal and Postprandial Glucose), PPG iAUC 5h, at Day 28|"Change from baseline in the incremental area under the curve of postprandial plasma glucose from 0 to 5 hours (PPG iAUC 5h), defined as the area under the curve of timepoints 0 to 5 hours after meal reduced by the pre-meal plasma glucose at 0 hours.
Note, healthy subjects only received a single dose of empa so assessments at day 28 are not applicable."|0 minutes (min), 15min, 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 4h 30min and 5h after meal at baseline and day 28|Treated set (OR) for patients who completed the day 28 visit||g/dL/h||Standard Error|Least Squares Mean
831649|NCT01248364|Primary|Change From Baseline in Glucose Metabolism (Pre-meal and Postprandial Glucose), PPG iAUC 5h, at Day 1|Change from baseline in the incremental area under the curve of postprandial plasma glucose from 0 to 5 hours (PPG iAUC 5h), defined as the area under the curve of timepoints 0 to 5 hours after meal reduced by the pre-meal plasma glucose at 0 hours.|0 minutes (min), 15min, 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 4h 30min and 5h after meal at baseline and day 1|Treated set (OR)||g/dL/h||Standard Error|Least Squares Mean
831650|NCT01248364|Secondary|Change From Baseline in Rate of Endogenous Glucose Production: AUC 5h, at Day 1|Change from baseline in the area under the curve of endogenous glucose production (EGP) from 0 to 5 hours (EGP AUC 5h) after meal.|0 minutes (min), 15min, 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 4h 30min and 5h after meal at baseline and day 1|Treated set (OR)||g||Standard Error|Least Squares Mean
831651|NCT01248364|Secondary|Change From Baseline in Rate of Endogenous Glucose Production: Fast, at Day 28|"Change from baseline in rate of endogenous glucose production (EGP) fast after 28 days of treatment.
Note, healthy subjects only received a single dose of empa so assessments at day 28 are not applicable."|Baseline and day 28|Treated set (OR) for patients who completed the day 28 visit||umol/kgFFM/min||Standard Error|Least Squares Mean
831652|NCT01248364|Secondary|Change From Baseline in Rate of Endogenous Glucose Production: Fast, at Day 1|Change from baseline in rate of endogenous glucose production (EGP) fast after one dose|Baseline and day 1|Treated set (OR)||umol/kgFFM/min||Standard Error|Least Squares Mean
831653|NCT01248364|Primary|Change From Baseline in Fasting Plasma Glucose at Day 28|"Change from baseline of Fasting Plasma glucose (FPG) 3 hours and 35 minutes before meal at day 28.
Note, healthy subjects only received a single dose of empa so assessments at day 28 are not applicable"|Baseline and day 28|Treated set, which included all patients/healthy subjects with at least one dose of empagliflozin (original result (OR)), for patients who completed the day 28 visit||mmol/L||Standard Error|Least Squares Mean
831654|NCT01248364|Primary|Change From Baseline in Fasting Plasma Glucose at Day 1|Change from baseline of Fasting Plasma glucose (FPG) 3 hours and 35 minutes before meal at day 1|Baseline and day 1|Treated set which included all patients/healthy subjects with at least one dose of empagliflozin (original result (OR))||mmol/L||Standard Error|Least Squares Mean
831655|NCT01248455|Secondary|Count of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|3 years, 5 months|||Participants|||Count of Participants
831656|NCT01248455|Primary|Response Rate|Response rate is defined as the percentage of participants with a 50% decline in monoclonal protein (M-protein) assessed by the International Multiple Myeloma Working Group (IMWG) for multiple myeloma (MM) criteria. Minimal response (MR) is MR >25% and <50% decrease in M-protein. Biochemical progression (BP) is asymptomatic, ≥ 25% M-protein increase from baseline and an absolute increase of M-protein of 0.75 g/dL demonstrated on two separate occasions. Progressive disease (PD), (clinical progression to symptomatic MM) is development of CRAB (hyperCalcemia (corrected calcium >2.75 mmol/L), Renal insufficiency (attributed to MM), Anemia (hemoglobin <10g/dL), and Bone lesions (lytic lesions or osteoporosis with compression fractures) criteria end organ damage. Stable disease (SD) is not meeting the criteria for minimal response, biochemical progression and progressive disease.|1 year|Study stopped after the first stage due to the lack of patients meeting the defined primary objective (50% decline in M-protein).||percentage of participants|||Number
831657|NCT01248468|Secondary|Percent of Subjects Who Are Free of Photophobia at 2 Hours.|Subjects assessed severity of relevant symptom on a 4 point scale (0=none, …, 3=severe) at set time points after dosing through 4 hours. Subjects who indicated severity of relevant symptom=none at 2 hours were considered relevant symptom free at 2 hours|2 hours|||Percent of participants|||Number
831658|NCT01248468|Secondary|Percent of Subjects Who Are Free of Phonophobia at 2 Hours.|Subjects assessed severity of relevant symptom on a 4 point scale (0=none, …, 3=severe) at set time points after dosing through 4 hours. Subjects who indicated severity of relevant symptom=none at 2 hours were considered relevant symptom free at 2 hours|2 hours|The basic population for efficacy analysis was ITT. No explicit process to impute missing values at any given assessment timepoint. Missing values were implicitly imputed by the repeated measures analysis statistical model. Consequently, at any given timepoint, the number of subjects analyzed is slightly less than the total ITT population.||Percent of participants|||Number
831659|NCT01248468|Secondary|Percent of Subjects Who Are Free of Nausea at 2 Hours.|Subjects assessed severity of relevant symptom on a 4 point scale (0=none, …, 3=severe) at set time points after dosing through 4 hours. Subjects who indicated severity of relevant symptom=none at 2 hours were considered relevant symptom free at 2 hours|2 hours|The basic population for efficacy analysis was ITT. No explicit process to impute missing values at any given assessment timepoint. Missing values were implicitly imputed by the repeated measures analysis statistical model. Consequently, at any given timepoint, the number of subjects analyzed is slightly less than the total ITT population.||percent of participants|||Number
831660|NCT01248468|Primary|Percent of Subjects Who Are Pain Free at 2 Hours.|Subjects assessed severity of pain on a 4 point scale (0=none, …, 3=severe) at set time points after dosing through 4 hours. Subjects who indicated severity of pain=none at 2 hours were considered pain free at 2 hours|2 hours|The basic population for efficacy analysis was ITT. No explicit process to impute missing values at any given assessment timepoint. Instead, missing values were implicitly imputed by the repeated measures analysis statistical model. So, at any given timepoint, the number of subjects analyzed is slightly less than the total ITT population.||Percent of participants|||Number
831661|NCT01248715|Secondary|Number of Participants With Hospital Mortality.|Number of subjects who died while hospitalized|Through study completion|||Participants|||Count of Participants
831662|NCT01248715|Secondary|Length of Hospital Stay|Duration of hospitalization calculated as the day of discharge minus the day of admission.|Through study completion|||days||Inter-Quartile Range|Median
831663|NCT01248715|Secondary|Days to Reach Clinical Stability|Time to clinical improvement. The criteria for clinical improvement were followed during the first week from the day of admission and defined as follows: a) improvement of signs and symptoms of LRTI reported by patient b) afebrile for at least 8 hours, c) decrease in white blood cell count to more than 10% from the prior day, and d) able to tolerate oral feeding. A patient was considered clinically improved on the day that these four criteria were all met.|30 days|||days||Inter-Quartile Range|Median
831664|NCT01248715|Primary|Number of Participants That Had Short-term Mortality|Number of subjects who died within 30 days of enrollment|30 days|||Participants|||Count of Participants
831665|NCT01248715|Primary|Number of Participants That Required Re-hospitalization|Participants that were re-hospitalized within 30 days after enrollment.|30 days|||Participants|||Count of Participants
832021|NCT01251653|Secondary|Duration of Disease Control According to RECIST v1.1|Duration of disease control according to RECIST v1.1.|From the first administration of study medication to the time of disease progression or death|TS for patients who experienced disease control.||Days||Standard Deviation|Mean
831666|NCT01248715|Primary|Number of Participants to Transfer to ICU After 24 h|Number of subjects that were transfered to an intensive care unit (ICU) after 24 hours of hospitalization. A patient transferred to ICU within 24 hours of admission was considered as a direct admission to ICU and not meeting criteria for clinical failure.|24 h|||Participants|||Count of Participants
831667|NCT01248715|Primary|Number of Participants With Clinical Failure (Failure to Reach Clinical Stability)|Number of subject that showed lack of clinical improvement within 7 days. Criteria for clinical improvement include no fever; white blood cell count decreases, or increases in the case of leukopenia, to more than 10% from the prior day; the evaluation of signs and symptoms of CAP to define when the patient is subjectively better, and the patient is able to tolerate food by mouth.|7 days|||Participants|||Count of Participants
831668|NCT01248728|Secondary|Change From Baseline in the Preschool Language Scale (PLS-4) - Total Language|"The PLS-4 is a language measure that provides a global assessment of a child's language functioning abilities, receptive and expressive language.
Secondary outcome measure domain: Total language standard score
Total Language Standard Score Range:
Minimum range: 50 (lower language abilities) Maximum range: 150 (higher language abilities)
The total language standard score is computed from a sum of the auditory comprehension and expressive communication standard scores, then converted into the total language standard score.
Change of total language standard scores from baseline to week 24 is reported. Positive change indicates improvement"|Baseline and 24 Weeks|1 participant was dropped from the analysis in the Omega-3 group as there was insufficient data due to early termination.||units on a scale||95% Confidence Interval|Mean
831669|NCT01248728|Secondary|Change From Baseline in the Vineland Adaptive Behavioral Scales (VABS) - Adaptive Functioning Composite|"The VABS is a measure of adaptive behavior in daily settings. Secondary measure domain: The adaptive functioning composite describes an individuals overall functioning
Adaptive Behaviour Composite Standard Score Range:
Minimum range: 20 (low adaptive functioning) Maximum range: 160 (high adaptive functioning)
The adaptive behaviour composite standard score is computed from the sum of standard scores from the communication, daily living skills, socialization and motor skills domains and converted into the adaptive behavior composite standard score.
Change in the adaptive behaviour composite standard score from baseline to week 24 is reported. Positive change indicates improvement."|Baseline and 24 Weeks|1 participant was dropped from the analysis in the Omega-3 group as there was insufficient data due to early termination.||units on a scale||95% Confidence Interval|Mean
831670|NCT01248728|Secondary|Number of Participants Classified as Responders by the Clinical Global Impression - Improvement (CGI-I)|"The CGI-I is a seven-point scale that provides a clinician rating of global improvement and as such is already inherently a measure of change. It requires the clinician to assess the degree to which the participant's illness has improved or worsened relative to a baseline state before the intervention.
Change is rated as:
0- Not assessed
Very Much Improved
Much Improved
Minimally Improved
No Change
Minimally Worse
Much Worse
Very Much Worse
Participants are classified as responders if their CGI-I score was 1 or 2 and non-responders for CGI-I scores of 3 to 7."|24 weeks|1 participant was dropped from the analysis in the Omega-3 group as there was insufficient data due to early termination.||participants classified as responders|||Number
831671|NCT01248728|Primary|Change From Baseline in the Behaviour Assessment System for Children (BASC-2) - Externalizing Problems Composite|"The BASC-2 externalizing problems composite measures hyperactivity and aggressive behaviours.
Primary Outcome domain: Externalizing Problems composite
Externalizing Problems Composite T-Score Range:
Minimum Range: 10 (lower externalizing problems) Maximum Range: 120 (higher externalizing problems)
The Externalizing Problems composite is computed from the sum of t-scores from the hyperactivity and aggression subscales then converted into the externalizing problems composite t-score.
Mean change between baseline and week 24 is reported. A negative change indicates improvement."|Baseline and 24 Weeks|1 participant was dropped from the analysis in the Omega-3 group as there was insufficient data due to early termination.||units on a scale||95% Confidence Interval|Mean
831672|NCT01248728|Primary|Change From Baseline in the Pervasive Developmental Disorder-Behavioral Inventory (PDDBI) - Autism Composite Score|"The PDDBI measures autism symptomology. The autism composite score was used as the primary outcome measure for autism symptom severity.
PDDBI Autism Composite Scale Range:
Minimum Range = 10 (lower autism symptom severity) Maximum Range = 100 (higher autism symptom severity)
The Autism Composite is calculated from the sum of T-scores of the Sensory/Perceptual Approach Behaviours, Ritualisms/Resistance to Change, Social Pragmatic Problems, and Semantic/Pragmatic Problems domains subtracted by the sum of T-scores of the Social Approach Behaviours, and Expressive Language domain then converted into the Autism Composite as a T-score.
Mean change between baseline and week 24 is reported. A negative change indicates improvement"|Baseline and 24 Weeks|1 participant was dropped from the analysis in the Omega-3 group as there was insufficient data due to early termination.||units on a scale||95% Confidence Interval|Mean
831673|NCT01248780|Secondary|HAQ (Disability Index of the Health Assessment Questionnaire) Score Change From Baseline|The HAQ assesses the degree of difficulty a person has in accomplishing tasks in 8 categories (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). The full range of the HAQ scale is 0-24 with 0 being the best possible outcome. The HAQ score is calculated as the sum of the category scores divided by the number of categories scored, giving a possible range of scores from 0 to 3 with 0 being the best possible outcome (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, or 3=unable to do). The mean change from baseline at Week 24 in HAQ score is provided below for each treatment group. A negative change from baseline is indicative of a lesser degree of difficulty in accomplishing tasks assessed in the HAQ.|Baseline to Week 24|Participants randomized (ie, intent-to-treat population) according to their assigned treatment group regardless of whether or not they received the assigned treatment.||Scores on a scale||Standard Deviation|Mean
831674|NCT01248780|Secondary|American College of Rheumatology 20 Response, Using CRP, at Week 24|ACR 20 response is defined as >= 20% improvement in rheumatoid arthritis (RA) symptoms and disease activity.|Week 24|Participants randomized (ie, intent-to-treat population) according to their assigned treatment group regardless of whether or not they received the assigned treatment.||Number of participants|||Number
831686|NCT01248884|Secondary|Number of Subjects Reporting Any Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.|During the 8-day (Days 0-7)|The analysis was performed on the Total Vaccinated cohort, which included all subjects for whom data were available.||Subjects|||Number
831675|NCT01248780|Secondary|Disease Activity Index Score (DAS 28) Response, Using CRP (C-reactive Protein)|"DAS28 using CRP is a measure of tender and swollen joints (28 joints each) and the patient’s assessments of disease activity. A score of higher than 5.1 indicates high disease activity, and a score below 3.2 indicates low disease activity. A DAS28 (using CRP) responder is defined as a participant with a DAS28 response of “Good” or “Moderate” at Week 14. A Good response is defined as a patient with a DAS28 score of <= 3.2 at Week 14 with improvement from Baseline in DAS28 score of > 1.2. A “Moderate” response was defined as a patient with DAS28 score of >3.2-5.1 at Week 14 with improvement from baseline in DAS28 score of >0.6 to >1.2 The table below shows the number of participants in each treatment group who were DAS28 responders at Week 14."|Week 14|Participants randomized (ie, intent-to-treat population) according to their assigned treatment group regardless of whether or not they received the assigned treatment.||Number of participants|||Number
831676|NCT01248780|Primary|American College of Rheumatology (ACR) 20 Response, Using CRP (C-reactive Protein), at Week 14|ACR 20 response is defined as >= 20% improvement in rheumatoid arthritis (RA) symptoms and disease activity.|Week 14|Participants randomized (ie, intent-to-treat population) according to their assigned treatment group regardless of whether or not they received the assigned treatment.||Number of participants|||Number
831677|NCT01248793|Secondary|Change From Baseline in the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 14|BASMI is a combined score of 5 components of spine flexibility, ranging from 0 (least impairment) to 10 (most impairment). A negative change from baseline indicates improvement.|Baseline and Week 14|Intent-to-treat population according to their assigned treatment group regardless of whether or not they receive the assigned treatment||Score on a scale||Standard Deviation|Mean
831678|NCT01248793|Secondary|Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 14|BASFI is a participant’s self-assessment, represented as a mean (Visual Analogue Scale [Score]; 0 cm [easy] to 10 cm [impossible]) of 10 questions, 8 of which relate to the participant’s functional anatomy and 2 of which relate to a participant’s ability to cope with everyday life. A negative change from baseline indicates improvement.|Baseline and Week 14|Intent-to-treat population according to their assigned treatment group regardless of whether or not they receive the assigned treatment||Score on a scale||Standard Deviation|Mean
831679|NCT01248793|Secondary|Assessment of Ankylosing Spondylitis Response (ASAS 20) at Week 24|Number of patients who achieved a >= 20% improvement in ankylosing spondylitis symptoms, including back pain, function, and inflammation|Week 24|Intent-to-treat population according to their assigned treatment group regardless of whether or not they receive the assigned treatment||Participants|||Number
831680|NCT01248793|Primary|Assessment of Ankylosing Spondylitis Response (ASAS 20) at Week 14|Number of patients who achieved a >= 20% improvement in ankylosing spondylitis symptoms, including back pain, function, and inflammation|Week 14|Intent-to-treat population according to their assigned treatment group regardless of whether or not they receive the assigned treatment||Participants|||Number
831681|NCT01248884|Primary|Concentrations for Anti-HBs Antibodies ≥ 10 and 100 mIU/mL|A decrease in the specificity of the anti-HB enzyme-linked immunosorbent assay (ELISA) had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis. Concentrations were expressed as geometric mean concentrations (GMCs) in milli-International units per milliliter (mIU/mL).|At Month 3|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.||mIU/mL||95% Confidence Interval|Geometric Mean
831682|NCT01248884|Primary|Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 10 and 100 Milli-International Units Per Milliliter (mIU/mL)|A decrease in the specificity of the anti-HB enzyme-linked immunosorbent assay (ELISA) had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis.|At Month 3|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.||Subjects|||Number
831683|NCT01248884|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Any SAE = any SAE regardless of assessment of relationship to study vaccination.|During the entire study period (Month 0 to Month 3)|The analysis was performed on the Total Vaccinated cohort, which included all subjects for whom data were available.||Subjects|||Number
831684|NCT01248884|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).|An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an AE regardless of intensity grade or relationship to study vaccination.|Within the 31-day (Days 0-30) follow up period after vaccination.|The analysis was performed on the Total Vaccinated cohort, which included all subjects for whom data were available.||Subjects|||Number
831685|NCT01248884|Secondary|Number of Subjects Reporting Any Solicited General Symptoms.|Solicited local symptoms assessed were drowsiness, irritability, loss of appetite and fever [axillary temperature above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any local symptom regardless of intensity grade.|During the 8-day (Days 0-7)|The analysis was performed on the Total Vaccinated cohort, which included all subjects for whom data were available.||Subjects|||Number
832072|NCT01252186|Secondary|Change From Baseline to End of Month 6 in D-dimer|D-dimer is the degradation product of cross-linked fibrin and is a marker of thrombin and fibrin formation and turnover.|Baseline to Month 6|Per-protocol population||ng/mL||Standard Error|Least Squares Mean
831687|NCT01248884|Secondary|Number of Subjects With a Vaccine Response to PT and PRN.|Vaccine response defined as: for initially seronegative subjects, antibody concentration ≥ 5 EL.U/mL at 1 month post primary vaccination (Month 3); for initially seropositive subjects, antibody concentration at 1 month post primary vaccination (Month 3) ≥ 1 fold the pre-vaccination antibody concentration.|At Month 3|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.||Subjects|||Number
831688|NCT01248884|Secondary|Concentrations for Anti-PNE Antibodies.|Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 0.15 µg /mL. The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.|At Month 3|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.||µg /mL||95% Confidence Interval|Geometric Mean
831689|NCT01248884|Secondary|Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.|A seropositive subject was defined as a vaccinated subject who had anti- pneumococcal antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL). The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.|At Month 3|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.||Subjects|||Number
831690|NCT01248884|Secondary|Concentrations for Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibodies.|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was ≥ 0.15 µg/mL.|At Month 3|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.||µg/mL||95% Confidence Interval|Geometric Mean
831691|NCT01248884|Primary|Number of Seroprotected Subjects for Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibodies.|A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).|At Month 3|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.||Subjects|||Number
831692|NCT01248884|Secondary|Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT) and Anti-pertactin (Anti-PRN) Antibodies.|A seropositive subject was defined as a vaccinated subject who had anti-PT and anti-PRN antibody concentrations ≥ 5 EL.U/mL.|At Months 0 and 3|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.||Subjects|||Number
831693|NCT01248884|Primary|Concentrations for Anti-pertussis Toxoid (Anti-PT) and Anti-pertactin (Anti-PRN) Antibodies.|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliters (EL.U/mL).|At Months 0 and 3|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.||EL.U/mL||95% Confidence Interval|Geometric Mean
831694|NCT01248884|Secondary|Concentrations for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL.|At Months 0 and 3|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.||IU/mL||95% Confidence Interval|Geometric Mean
831695|NCT01248884|Primary|Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.|A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).|At Months 0 and 3|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.||Subjects|||Number
831696|NCT01248936|Primary|Number of Participants With Any Serious Adverse Event, Death and Cause of Death|Serious Adverse Event (SAEs) is defined as those events that were fatal or immediately life-threatening, and those events that resulted in hospitalization; prolonged an existing hospitalization; resulted in disability; or was a congenital anomaly. Number of participants who died and the cause of death are also recorded.|Up to 1 year|The safety population was defined as participants who received at least one dose, or a partial dose, of vemurafenib.||participants|||Number
831697|NCT01248936|Primary|Number of Participants With Any Adverse Event, Adverse Events With Severity, Adverse Events Leading to Discontinuation|An Adverse Event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs will be graded according to the ‘National Cancer Institute Common Terminology Criteria for Adverse Events’ (NCI CTCAE, v4.0). However Laboratory data will be summarized by grade using the NCI CTCAE, v4.0 toxicity grade.|Up to 1 year|The safety population was defined as participants who received at least one dose, or a partial dose, of vemurafenib.||participants|||Number
831698|NCT01248936|Secondary|Mean Time to Complete Response/Partial Response|Mean time to Complete Response (CR)/Partial Response(PR) (confirmed or unconfirmed was assessed). Participants were assessed for best overall response by investigator as per RECIST v1.1.|Up to 1 year|The efficacy population was defined as treated participants who had measurable disease at baseline and at least one post-baseline tumor assessment.||Months||Standard Deviation|Mean
831699|NCT01248936|Secondary|Number of Participants With Best Overall Response (Confirmed) by ECOG Performance|The best overall response recorded from the start of the treatment until disease progression/recurrence which was confirmed in patients with Eastern Cooperative Oncology Group (ECOG) performance status 2 or 3/0 or 1. Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair >50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead. Participants were assessed for best overall response by investigator as per RECIST v1.1. The ‘n’ is number of participants with ECOG performance status in each criteria.|Up to 1 year|The efficacy population was defined as treated participants who had measurable disease at baseline and at least one post-baseline tumor assessment.||Participants|||Number
831700|NCT01248936|Secondary|Number of Participants With Best Overall Response (Confirmed)|The best overall response (confirmed) is the best response recorded from the start of the treatment until disease progression/recurrence which was confirmed. Participants were assessed for best overall response by investigator as per RECIST v1.1.|Up to 1 year|The efficacy population was defined as treated participants who had measurable disease at baseline and at least one post-baseline tumor assessment.||Participants|||Number
831701|NCT01248936|Secondary|Number of Participants With Best Overall Response (Unconfirmed) by ECOG Performance|The best overall response recorded from the start of the treatment until disease progression/recurrence which was unconfirmed in patients with Eastern Cooperative Oncology Group (ECOG) performance status 2 or 3/0 or 1. Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair >50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead. This endpoint was tumor response category according to investigator assessment per RECIST v1.1 for efficacy assessment. The ‘n’ is number of participants with ECOG performance status in each criteria.|Up to 1 year|The efficacy population was defined as treated patients who had measurable disease at baseline and at least one post-baseline tumor assessment.||Participants|||Number
831702|NCT01248936|Secondary|Number of Participants With Best Overall Response (Unconfirmed)|The best overall response (unconfirmed) is the best response recorded from the start of the treatment until disease progression/recurrence which was unconfirmed. Participants were assessed for best overall response by investigator as per 'Response Evaluation Criteria in Solid Tumors' (RECIST v1.1).|Up to 1 year|The efficacy population was defined as treated participants who had measurable disease at baseline and at least one post-baseline tumor assessment.||participants|||Number
831703|NCT01248949|Primary|Number of Participants With a Decline in Karnofsky Performance Status (KPS) of ≥ 20 Points at Worst Record On-study Compared With Baseline|KPS scale: 100 is no evidence of disease; 90 is able to carry on normal activity, minor symptoms of disease; 80 is normal activity with effort, some symptoms of disease; 70 is cares for self; unable to do active work; 60 is requires occasional assistance, but is able to care for most of his needs; 50 is requires considerable assistance with frequent medical care; 40 is disabled, requires special care; 30 is severely disabled, hospitalization is indicated although death is not imminent; 20 is very sick, hospitalization necessary, active support treatment necessary; 10 is moribund, fatal processes progressing rapidly, 0 is dead.|From start of study drug administration up to 30 days after the last dose of MEDI3617|Safety population included all participants who received treatment with MEDI3617||Participants|||Number
831704|NCT01248949|Secondary|Circulating Levels of Angiopoietin 2 (Ang2)|Profile of Ang2 post MEDI3617 administration in relation to time course of antibody concentrations.|Prior to infusion on Cycle 4 and Cycle 5|All participants who received treatment with MEDI3617 and for whom PD blood samples were collected and evaluated.||nanogram per millileter (ng/mL)||Standard Deviation|Mean
831705|NCT01248949|Secondary|Overall Survival (OS)|Overall survival is defined as the time from the start of treatment with MEDI3617 until death. For the participants who were alive at the end of study or lost to follow-up, overall survival was censored on the last date when participants were known to be alive. Overall survival was evaluated using the Kaplan-Meier method.|Time from the first dose of investigational product until death due to any cause|Safety population included all participants who received treatment with MEDI3617.||months||Full Range|Median
831706|NCT01248949|Secondary|Progression-Free Survival (PFS)|PFS was measured from the start of treatment with MEDI3617 until the documentation of disease progression or death due to any cause, whichever occurred first. PFS was censored on the date of last tumor assessment documenting absence of tumor progression for participants who have no documented progression and were still alive prior to data cutoff, dropout, or the initiation of alternate anticancer treatment. Participants having no tumor assessments after the start of treatment with MEDI3617 had PFS censored on the first date of treatment with MEDI3617. PFS was evaluated using the Kaplan-Meier method.|Time from the first dose of investigational product until end of study|Safety population included all participants who received treatment with MEDI3617.||months||Full Range|Median
831707|NCT01248949|Secondary|Time to Progression (TTP)|Time to progression (TTP) is defined as time from the start of treatment with MEDI3617 until the documentation of disease progression. The TTP was censored on the date of last tumor assessment documenting absence of tumor progression for participants who have no documented progression prior to data cutoff, dropout, or the initiation of alternate anticancer treatment. Participants having no tumor assessments after the start of treatment with MEDI3617 had TTP censored on the first date of treatment with MEDI3617. TTP was evaluated using the Kaplan-Meier method.|Time from the first dose of investigational product until end of study|Safety population included all participants who received treatment with MEDI3617.||months||Full Range|Median
831708|NCT01248949|Secondary|Duration of Response (DOR)|Duration of response is defined as the duration from the first documentation of objective disease response (ie, confirmed CR or confirmed PR) to the first documented disease progression. The duration of response was censored on the date of last tumor assessment documenting absence of disease progression for participants who have no documented progression prior to data cutoff, dropout, or the initiation of alternate anticancer treatment. Duration of response was evaluated for the subgroup of participants with an objective response using the Kaplan-Meier method.|Time from the first dose of investigational product until end of study|Safety population included all participants who received treatment with MEDI3617.||months||Full Range|Median
831709|NCT01248949|Secondary|Time to Response (TTR)|Time to response (TTR) is defined as the time from the study entry to the first documentation of confirmed CR or confirmed PR. CR was defined as disappearance of all target lesions, any pathological lymph nodes must have reduction in short axis to less than (<) 10 millimeter (the sum may not be “0” if there are target nodes). PR was defined as at least a 30 percent (%) decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Analysis was based on responses confirmed at a repeat assessment made at least 4 weeks after the initial response, with the TTR taken as the first time the response was observed, not the confirmation assessment. TTR was evaluated using the Kaplan-Meier method.|Time from the first dose of investigational product until end of study|Safety population included all participants who received treatment with MEDI3617.||months||Full Range|Median
831710|NCT01248949|Secondary|Objective Response Rate (ORR)|Objective response rate defined as the number of participants with confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR was defined as disappearance of all target lesions, any pathological lymph nodes must have reduction in short axis to less than (<) 10 millimeter (the sum may not be “0” if there are target nodes). PR was defined as at least a 30 percent (%) decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.|Time from the first dose of investigational product until end of study|Safety population included all participants who received treatment with MEDI3617.||Participants|||Number
831711|NCT01248949|Secondary|Number of Participants With Positive Anti-Drug Antibody (ADA)|The immunogenic potential of MEDI3617 was assessed by summarizing the number and percentage of participants who develop detectable ADA. Immunogenicity assessment included determination of anti-drug (MEDI3617) antibodies in serum samples. Samples were measured for the presence of ADA using validated immunoassays.|Presence of ADA to MEDI3617 were assessed prior to infusion with MEDI3617 on Day 1 of each dosing cycle, as well as the end of treatment, and 30 days, 3 months, and 6 months post last dose of MEDI3617|All participants who received treatment with MEDI3617.||participants|||Number
831712|NCT01248949|Secondary|Terminal Elimination Half Life (t1/2) of MEDI3617|"The t1/2 is the time in days required for the concentration of the drug to reach half of its original value. Here, n is number of participants analyzed for this endpoint at a specific dose."|Days 1, 2 (MEDI3617 single agent only), 4, 8, 15 (Cycle 1); Day 1 (Cycle 2 and every cycle after), Day 15 (MEDI3617 + bev Q2W and MEDI3617 + paclitaxel only, Cycle 2 and every cycle after); end of treatment; 30 days and 3 months post last dose|All participants who received treatment with MEDI3617 and for whom PK blood samples were collected and evaluated.||day||Standard Deviation|Mean
831713|NCT01248949|Secondary|Systemic Clearance (CL) of MEDI3617|"Systemic clearance describes the removal of drug from a volume of serum in a given unit of time (drug loss from the body). It is measured as milliliter per day (mL/day). Here, n is number of participants analyzed for this endpoint at a specific dose."|Days 1, 2 (MEDI3617 single agent only), 4, 8, 15 (Cycle 1); Day 1 (Cycle 2 and every cycle after), Day 15 (MEDI3617 + bev Q2W and MEDI3617 + paclitaxel only, Cycle 2 and every cycle after); end of treatment; 30 days and 3 months post last dose|All participants who received treatment with MEDI3617 and for whom PK blood samples were collected and evaluated.||milliliter per day (mL/day)||Standard Deviation|Mean
831714|NCT01248949|Secondary|Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617|"The AUC0-inf is the Area Under the Concentration-Time Curve From Time Zero to infinity of MEDI3617. Here, n is number of participants analyzed for this endpoint at a specific dose."|Days 1, 2 (MEDI3617 single agent only), 4, 8, 15 (Cycle 1); Day 1 (Cycle 2 and every cycle after), Day 15 (MEDI3617 + bev Q2W and MEDI3617 + paclitaxel only, Cycle 2 and every cycle after); end of treatment; 30 days and 3 months post last dose|All participants who received treatment with MEDI3617 and for whom PK blood samples were collected and evaluated.||day*mcg/mL||Standard Deviation|Mean
831715|NCT01248949|Secondary|Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617|"AUC0-last is the Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration of MEDI3617. Here, n is number of participants analyzed for this endpoint at a specific dose."|Days 1, 2 (MEDI3617 single agent only), 4, 8, 15 (Cycle 1); Day 1 (Cycle 2 and every cycle after), Day 15 (MEDI3617 + bev Q2W and MEDI3617 + paclitaxel only, Cycle 2 and every cycle after); end of treatment; 30 days and 3 months post last dose|All participants who received treatment with MEDI3617 and for whom PK blood samples were collected and evaluated.||day*mcg/mL||Standard Deviation|Mean
831716|NCT01248949|Secondary|Maximum Observed Serum Concentration (Cmax) of MEDI3617|"Cmax is the maximum observed serum concentration of MEDI3617. Here, n is number of participants analyzed for this endpoint at a specific dose."|Days 1, 2 (MEDI3617 single agent only), 4, 8, 15 (Cycle 1); Day 1 (Cycle 2 and every cycle after), Day 15 (MEDI3617 + bev Q2W and MEDI3617 + paclitaxel only, Cycle 2 and every cycle after); end of treatment; 30 days and 3 months post last dose|All participants who received treatment with MEDI3617 and for whom PK blood samples were collected and evaluated.||microgram per milliliter (mcg/ml)||Standard Deviation|Mean
831717|NCT01248949|Primary|Number of Participants With Electrocardiogram Abnormalities Recorded as Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant administered investigational product and which does not necessarily have a causal relationship with this treatment. AEs related to electrocardiogram abnormalities were recorded and reported. The only AE reported was electrocardiogram QT prolonged in the MEDI3617 + Bevacizumab Q2W total group.|From start of study drug administration up to 90 days after the last dose of MEDI3617|Safety population included all participants who received treatment with MEDI3617||Participants|||Number
832680|NCT01250730|Primary|Metabolite to Parent Ratio AUClast|The metabolic ratio (MR) is calculated by first converting the AUClast for both crizotinib and metabolite (PF-06260182) from mass units to molar units.|0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose|||ratio||Standard Deviation|Geometric Mean
831718|NCT01248949|Primary|Number of Participants With Echocardiogram Abnormalities Recorded as Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant administered investigational product and which does not necessarily have a causal relationship with this treatment. AEs related to echocardiogram abnormalities were recorded and reported. The only AE reported was ejection fraction decreased in the MEDI3617 + Paclitaxel total group.|From start of study drug administration up to 90 days after the last dose of MEDI3617|Safety population included all participants who received treatment with MEDI3617.||Participants|||Number
831719|NCT01248949|Primary|Number of Participants With Vital Sign Abnormalities Recorded as Adverse Events (AEs)|Vital signs included parameters such as heart rate, blood pressure, temperature, weight and respiratory rate. An AE was any untoward medical occurrence in a participant administered investigational product and which does not necessarily have a causal relationship with this treatment. AEs related to vital signs abnormalities were recorded and reported.|From start of study drug administration up to 90 days after the last dose of MEDI3617|Safety population included all participants who received treatment with MEDI3617.||Participants|||Number
831720|NCT01248949|Primary|Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs)|Laboratory evaluations were performed, including hematology and serum chemistry. An AE was any untoward medical occurrence in a participant administered investigational product and which does not necessarily have a causal relationship with this treatment. AEs related to laboratory abnormalities were recorded and reported.|From start of study drug administration up to 90 days after the last dose of MEDI3617|Safety population included all participants who received treatment with MEDI3617.||Participants|||Number
831721|NCT01248949|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant administered investigational product and which does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were events occurring after administration of investigational product.|From start of study drug administration up to 90 days after the last dose of MEDI3617|Safety population included all participants who received treatment with MEDI3617.||Participants|||Number
831722|NCT01248949|Primary|Maximum Tolerated Dose (MTD)|The dose-escalation phase used a 3 + 3 design. If greater than or equal to 2 (≥ 2) participants in a dose cohort experienced a DLT during the DLT period, the MTD was exceeded and no further participants were enrolled into that dose cohort. If this occurred, the preceding dose cohort was evaluated for the MTD and a total of 6 participants were treated at the preceding dose. If less than or equal to 1 (≤ 1) of 6 participants experienced a DLT at the preceding dose, then this dose level was the MTD. DLTs were defined as any treatment-related, grade 3 or higher toxicity (according to the National Cancer Institute’s Common Terminology Criteria for Adverse Events [NCI CTCAE] version 4.0); occurring during the first 21 or 28 days after the initial administration of MEDI3617.|From the time of first administration of MEDI3617 single agent or MEDI3617 combination therapy through the first 21-day or 28-day cycle (Cycle 1)|DLT Evaluable population included all participants enrolled in dose-escalation, who received at least 1 full assigned dose of single-agent MEDI3617 or full assigned doses of MEDI3617 and standard therapeutic agents on Cycle 1 and completed safety follow-up or experienced a DLT at any point during the 21-day or 28-day DLT evaluation period.||milligram (mg)|||Number
831723|NCT01248949|Primary|Number of Participants With Dose Limiting Toxicities (DLTs)|DLT was defined as any treatment-related, grade 3 or higher toxicity (according to the National Cancer Institute’s Common Terminology Criteria for Adverse Events [NCI CTCAE] version 4.0); occurring during the first 21 or 28 days after the initial administration of MEDI3617.|From the time of first administration of MEDI3617 single agent or MEDI3617 combination therapy through the first 21-day or 28-day cycle (Cycle 1)|DLT Evaluable population included all participants enrolled in dose-escalation, who received at least 1 full assigned dose of single-agent MEDI3617 or full assigned doses of MEDI3617 and standard therapeutic agents on Cycle 1 and completed safety follow-up or experienced a DLT at any point during the 21-day or 28-day DLT evaluation period.||Participants|||Number
831724|NCT01249092|Secondary|Safety of Therapy in the Pilot Study of PTX Therapy in Patients With PBC Will be Assessed|The number of participants that experienced any severe adverse events will be monitored and recorded.|6 months|||participants|||Number
831725|NCT01249092|Secondary|Change in Serum Concentration of Tissue Inhibitor Metalloproteinase 1 (TIMP-1) After PTX Therapy.|Serum concentration of tissue inhibitor metalloproteinase 1 (TIMP-1), a fibrosis biomarker of interest, will be measured and the change in serum levels between entry and end of study will be calculated.|6 months|Serum samples from both timepoints (entry and end of study) were available in only 16 of the 18 subjects who completed the study.||ng/mL||Standard Error|Mean
831726|NCT01249092|Primary|Change in Serum Alkaline Phosphatase Levels.|Serum alkaline phosphatase levels at entry and at 6 months of therapy with PTX will be measured and compared.|6 months|||U/L||Standard Deviation|Mean
831727|NCT01249118|Primary|Percent of GDC-0973 Excreted in the Urine (% Excreted) for IV and Oral GDC-0973|% Excreted is the mean percentage of dose recovery in urine and calculated as: (Aeu divided by dose) multiplied by 100, where Aeu was amount of drug excreted in urine from time 0 to 96 hrs post-dose.|Part 2: 0 to 12, 12 to 24, 24 to 48, 48 to 72, and 72 to 96 Hrs post-dose|Full analysis population.||Percent dose excreted||Geometric Coefficient of Variation|Geometric Mean
831728|NCT01249118|Primary|Renal Clearance (CLR) of IV and Oral GDC-0973|CLR was calculated as Aeu divided by AUC (0 - ∞), where Aeu was amount of drug excreted in urine from time 0 to 96 hrs post-dose and AUC(0 - ∞) was area under the concentration-time curve of the analyte in plasma over the time interval from zero extrapolated to infinity hrs post-dose.|Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1 for plasma; 0 to 12, 12 to 24, 24 to 48, 48 to 72, and 72 to 96 Hrs post-dose for urine|Full analysis population.||L/hr||Geometric Coefficient of Variation|Geometric Mean
831744|NCT01249118|Primary|Maximum Observed Plasma Concentration (Cmax) of IV and Oral GDC-0973||Part 2: 0 hours (Hrs) (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1|Full analysis population included participants who were randomized, received study drug, and had at least 1 valid PK parameter.||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
831729|NCT01249118|Primary|Amount of Drug Excreted in the Urine (Aeu) of IV and Oral GDC-0973|The cumulative amount of drug excreted in urine over the entire collection interval of 96 hrs was calculated by adding the Aeu of the intervals 0 to 12, 12 to 24, 24 to 48, 48 to 72, and 72 to 96 hrs where Aeu was calculated by multiplying the urine volume within the collection interval by the associated drug concentration.|Part 2: 0 to 12, 12 to 24, 24 to 48, 48 to 72, and 72 to 96 Hrs post-dose on Day 1|Full analysis population.||mg||Geometric Coefficient of Variation|Geometric Mean
831730|NCT01249118|Primary|Mean Absorption Time (MAT)|MAT is mean time required for the drug to reach the central compartment. MAT was estimated from the mean resident time (MRT) from oral and IV administration. MAT was calculated as MRT last of oral dose minus MRT last of IV dose. MAT is analyzed when drug is administered orally (only for non-IV routes of administration).|Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1|"Full analysis population who received oral dose of GDC-0973. Here, number of participants analyzed signified those participants who were evaluable for this outcome."||hr||Geometric Coefficient of Variation|Geometric Mean
831731|NCT01249118|Primary|Absolute Oral Bioavailability (F) of GDC-0973|Absolute oral bioavailability is the amount of drug from a formulation that reaches the systemic circulation relative to an IV dose. F = [AUC (0-∞), oral multiplied by Dose IV] divided by [AUC (0-∞), IV multiplied by Dose oral]. Absolute oral bioavailability is determined for drugs which are administered orally. IV dose is 100% in systemic circulation (dosed directly) and hence no estimation is required.|Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1|Full analysis population who received oral dose of GDC-0973.||Ratio||Geometric Coefficient of Variation|Geometric Mean
831732|NCT01249118|Primary|Apparent Volume of Distribution (Vz/F) of Oral GDC-0973|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vz/F is influenced by the fraction absorbed.|Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1|Full analysis population who received oral dose of GDC-0973.||Liter||Geometric Coefficient of Variation|Geometric Mean
831733|NCT01249118|Primary|Volume of Distribution at Steady State (Vss) of IV GDC-0973|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vss is the apparent volume of distribution at steady-state.|Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose of Day 1|Full analysis population who received IV dose of GDC-0973.||Liter||Geometric Coefficient of Variation|Geometric Mean
831734|NCT01249118|Primary|Apparent Oral Clearance (CL/F) of Oral GDC-0973|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modelling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1|Full analysis population who received oral dose of GDC-0973.||L/hr||Geometric Coefficient of Variation|Geometric Mean
831735|NCT01249118|Primary|Systemic Clearance (CL) of IV GDC-0973|CL is a quantitative measure of the rate at which a drug substance is removed from the body.|Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1|Full analysis population who received IV dose of GDC-0973.||Liter (L)/hr||Geometric Coefficient of Variation|Geometric Mean
831736|NCT01249118|Primary|Plasma Decay Half-Life (t1/2) of IV and Oral GDC-0973|t1/2 is the time measured for the plasma concentration of GDC-0973 to decrease by one half.|Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1|Full analysis population.||hr||Geometric Coefficient of Variation|Geometric Mean
831737|NCT01249118|Primary|Dose Normalized AUC (0 - ∞) [AUC (0 - ∞)dn] of IV and Oral GDC-0973|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). AUC (0 - ∞)dn is AUC(0 - ∞) divided by dose.|Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1|Full analysis population.||ng*hr/mL/mg||Geometric Coefficient of Variation|Geometric Mean
831738|NCT01249118|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of IV and Oral GDC-0973|AUC (0 - ∞)= Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1|Full analysis population.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
831739|NCT01249118|Primary|Dose Normalized AUC (0-t) [AUC (0-t)dn] of IV and Oral GDC-0973|AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t). AUC (0-t)dn is AUC (0-t) divided by dose.|Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1|Full analysis population.||ng*hr/mL/mg||Geometric Coefficient of Variation|Geometric Mean
831740|NCT01249118|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of IV and Oral GDC-0973|AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t).|Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1|Full analysis population.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
831741|NCT01249118|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of IV and Oral GDC-0973||Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1|Full analysis population.||hr||Full Range|Median
831742|NCT01249118|Primary|Minimum Observed Plasma Trough Concentration (Cmin) of IV and Oral GDC-0973||Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1|Full analysis population.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
831743|NCT01249118|Primary|Dose Normalized Cmax [Cmax(dn)] of IV and Oral GDC-0973|Cmax(dn) is Cmax divided by dose.|Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1|Full analysis population.||ng/mL/mg||Geometric Coefficient of Variation|Geometric Mean
831840|NCT01243320|Primary|Change In Mean Corpuscular Hemoglobin Concentration Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 days|||gm/dL||95% Confidence Interval|Mean
831745|NCT01249131|Primary|Apparent Volume of Distribution (V/F)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|Day 1 at 0 hour (predose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 hours postdose|Pharmacokinetic parameters populations included all enrolled participants. Here, number of participants analyzed = participants who were evaluable for this outcome.||Liters (L)||Geometric Coefficient of Variation|Geometric Mean
831746|NCT01249131|Primary|Apparent Oral Clearance (CL/F)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Day 1 at 0 hour (predose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 hours postdose|Pharmacokinetic parameters populations included all enrolled participants. Here, number of participants analyzed = participants who were evaluable for this outcome.||Liters per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
831747|NCT01249131|Primary|Minimum Observed Plasma Concentration (Cmin)||Day 1 at 0 hour (predose)|Pharmacokinetic parameters populations included all enrolled participants. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
831748|NCT01249131|Primary|Maximum Observed Plasma Concentration (Cmax)||Day 1 at 0 hour (predose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 hours postdose|Pharmacokinetic parameters populations included all enrolled participants. Here, number of participants analyzed = participants who were evaluable for this outcome.||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
831749|NCT01249131|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)|AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf).|Day 1 at 0 hour (predose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 hours postdose|Pharmacokinetic parameters populations included all enrolled participants. Here, number of participants analyzed = participants who were evaluable for this outcome.||nanograms*hours/milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
831750|NCT01249157|Primary|To Evaluate the Accuracy of Preoperative 18FDG PEM|using pathology as the gold standard and descriptively compare it to the accuracy of breast MRI in an exploratory analysis which will generate data for future studies. The first 5 patients who consent to the study were used for training purposes only.|2 years|No data displayed because Outcome Measure has zero total participants analyzed.|||||
831751|NCT01249261|Primary|Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 12/Endpoint, ITT Population|Baseline, Year 1 compared with Endpoint (last measurement during the treatment period through Month 12), Year 8. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).|Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8)|ITT Population||Percent Change||Standard Error|Mean
831752|NCT01249261|Primary|Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 12, ITT Population|Baseline, Year 1 compared with Month 12, Year 8. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).|Baseline Core Study (Year 1) to Month 12 (Year 8)|ITT Population||Percent Change||Standard Error|Mean
831753|NCT01249261|Primary|Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 6, ITT Population|Baseline, Year 1 compared with Month 6, Year 8. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).|Baseline Core Study (Year 1) to Month 6 (Year 8)|ITT Population||Percent Change||Standard Error|Mean
831754|NCT01249261|Primary|Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 12/Endpoint, ITT Population|Endpoint is the last measurement during the treatment period (through Month 12, Year 8) compared with baseline Year 1. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).|Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8)|ITT Population||Percent Change||Standard Error|Mean
831755|NCT01249261|Primary|Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 12, ITT Population|Baseline, year 1 compared with Month 12, year 8. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).|Baseline Core Study (Year 1) to Month 12 (Year 8)|ITT Population||Percent Change||Standard Error|Mean
831756|NCT01249261|Primary|Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 6, ITT Population|Month 6, Year 8 compared to Baseline, Year 1. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).|Baseline Core Study (Year 1) to Month 6 (Year 8)|ITT Population||Percent Change||Standard Error|Mean
831757|NCT01249261|Primary|Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 12/Endpoint, ITT Population|Endpoint is the last measurement during the treatment period (thru Month 12, Year 8). Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. Normalized baseline femoral neck BMD lunar equipment only 0.836*BMD - 0.008; Hologic reference. All scans analyzed centrally by Synarc (Portland, OR).|Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8)|ITT Population||Percent Change||Standard Error|Mean
831758|NCT01249261|Primary|Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 12, ITT Population|Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. Normalized baseline femoral neck BMD lunar equipment only 0.836*BMD - 0.008; Hologic reference. All scans analyzed centrally by Synarc (Portland, OR).|Baseline Core Study (Year 1) to Month 12 (Year 8)|ITT Population||Percent Change||Standard Error|Mean
831759|NCT01249261|Primary|Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 6, ITT Population|Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. Normalized baseline femoral neck BMD lunar equipment only 0.836*BMD - 0.008; Hologic reference. All scans analyzed centrally by Synarc (Portland, OR).|Baseline Core Study (Year 1) to Month 6 (Year 8)|ITT Population||Percent Change||Standard Error|Mean
831760|NCT01249261|Primary|Mean Percent Change in Lumbar Spine BMD From Core Study Baseline, Month 12/Endpoint, ITT Population|Endpoint is the last measurement during the 12 month treatment period during Year 8. Hologic or Lunar Machines: same equipment used in prior study should be used for all patient visits. sBMD (standardized BMD): Lunar sBMD = 952.2*BMD, Hologic sBMD = 1075.5*BMD. All scans analyzed centrally by Synarc (Portland, OR).|Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8)|ITT Population||Percent Change||Standard Error|Mean
831761|NCT01249261|Primary|Mean Percent Change in Lumbar Spine BMD From Core Study Baseline, Month 12, ITT Population|Hologic or Lunar Machines: same equipment used in prior study should be used for all patient visits. sBMD (standardized BMD): Lunar sBMD = 952.2*BMD, Hologic sBMD = 1075.5*BMD. All scans analyzed centrally by Synarc (Portland, OR).|Baseline Core Study (Year 1) to Month 12 (Year 8)|ITT Population||Percent Change||Standard Error|Mean
831762|NCT01249261|Primary|Mean Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Core Study Baseline, Month 6, Intention to Treat (ITT) Population|Hologic or Lunar Machines: same equipment used in prior study should be used for all patient visits. sBMD (standardized BMD): Lunar sBMD = 952.2*BMD, Hologic sBMD = 1075.5*BMD. All scans analyzed centrally by Synarc (Portland, OR).|Baseline Core Study (Year 1) to Month 6 (Year 8)|ITT Population||Percent Change||Standard Error|Mean
831763|NCT01249274|Post-Hoc|Relapse to Cocaine Use During Treatment Period or 3 Months Post Treatment|Post-hoc sensitivity test to compare hazard of relapse to cocaine use between two treatment groups among participants (n=41) who did not report using cocaine at intake.|baseline to 3 months post 12-week trial period|intent-to-treat||participants who relapsed to cocaine use|||Number
831764|NCT01249274|Post-Hoc|Relapse to Cocaine Use During Treatment Period|Post-hoc sensitivity test to compare hazard of relapse to cocaine use between two treatment groups among participants (n=41) who did not report using cocaine at intake.|baseline to 12 weeks|intent-to-treat||participants who relapsed to cocaine use|||Number
831765|NCT01249274|Secondary|Salivary Progesterone Concentrations|A comparison of salivary progesterone concentrations across all samples for all timepoints|week 2, week 6, week 10, week 12|intent-to-treat||pg/ml of salivary progesterone||Standard Error|Mean
831766|NCT01249274|Secondary|Depression (Measured Weekly Using Edinburgh Postnatal Depression Scale (EPDS))|EPDS scores were measured to detect depression as a possible adverse event and compare scores between the two groups. The scale consists of 10 items. Each item is scored from 0 to 3, and the 10 items are summed to calculate a total score with a possible range of 0 to 30 and higher scores indicating more severe depression.|baseline to 12 weeks|intent-to-treat||units on a scale||Standard Error|Mean
831767|NCT01249274|Secondary|Cocaine Craving (Measured Weekly Using CCQ-Brief)|CCQ-Brief is a ten-item questionnaire developed from the 45-item CCQ. Each item is scored on a visual analogue scale ranging from 1-7, and items are averaged to yield a score from 1 to 7. Higher scores indicate stronger cocaine cravings.|baseline to 12 weeks|intent-to-treat||units on a scale||95% Confidence Interval|Mean
831768|NCT01249274|Secondary|Overall Comparison of Adverse Events Between Women in Placebo and Progesterone Group|To obtain information about the safety and tolerability of progesterone treatment in the postpartum period, women were queried at every visit about onset of adverse events, their seriousness, and their relatedness to study medication. Such data was monitored in SAETRS.|12 weeks postpartum|intent-to-treat||adverse events|||Number
831769|NCT01249274|Primary|Proportion of Positive Urine Samples Per Week|Primary aim: to evaluate whether postpartum women with a history of cocaine abuse or dependence use less cocaine if they are randomized to progesterone than placebo. Urine tox tests obtained qualitative and quantitative data on cocaine metabolites and other substances.|baseline, end of trial (week 12) and 3-month post-trial follow-up|intent-to-treat||proportion of positive urines per week||95% Confidence Interval|Mean
831770|NCT01249274|Primary|Proportion of Positive Urine Samples Per Week|Primary aim: to evaluate whether postpartum women with a history of cocaine abuse or dependence use less cocaine if they are randomized to progesterone than placebo. Urine tox tests obtained qualitative and quantitative data on cocaine metabolites and other substances.|weekly measurements, baseline to 12 weeks|intent-to-treat||proportion of positive urines per week||95% Confidence Interval|Mean
831771|NCT01249274|Primary|Number of Days of Cocaine Use Between 12 Week Visits & the 3 Month Follow up|Primary aim: to evaluate whether postpartum women with a history of cocaine abuse or dependence use less cocaine if they are randomized to progesterone than placebo. Measured by self-reported days of cocaine use per week during the trial period and during 3 month follow up using the substance use calendar|baseline, end of trial (week 12), 3-month post-trial follow-up|intent-to-treat||days of cocaine use between visits||95% Confidence Interval|Mean
831772|NCT01249274|Primary|Mean Number of Days Per Week of Cocaine Use|Primary aim: to evaluate whether postpartum women with a history of cocaine abuse or dependence use less cocaine if they are randomized to progesterone than placebo. Measured by self-reported days of cocaine use per week via substance use calendar.|Weekly measurements, Baseline to 12 weeks|intent-to-treat||number of days per week of cocaine use||Standard Deviation|Mean
831773|NCT01249417|Secondary|Goal Attainment Scale (GAS) Score|GAS is a functional scale used to measure progress towards individual therapy goals. Individual goals defined for each subject by the physician, and the child's parents (caregiver) where applicable, prior to treatment. Post-baseline, the GAS for each goal rated using a defined scale (-2: Much less than expected outcome, -1: somewhat less than expected outcome, 0: expected outcome, 1: somewhat more than expected outcome, and 2: Much more than expected outcome).|Week 4|ITT population, defined as all randomised subjects who received at least one injection of study treatment and who had a MAS score in the GSC assessed both at baseline and at Week 4.||units on a scale||95% Confidence Interval|Least Squares Mean
831774|NCT01249417|Secondary|Physician’s Global Assessment (PGA) of the Treatment Response.|PGA Scale of the Treatment Response: Global assessment of treatment response assessed by asking the Investigator the following question: “how would you rate the response to treatment in the subject’s lower limb(s) since the last injection?” Answers will be made on a 9 point rating scale (-4: markedly worse, -3: much worse, -2: worse, -1: slightly worse, 0: no change, +1: slightly improved, +2: improved, +3: much improved, +4: markedly improved).|Week 4|ITT population, defined as all randomised subjects who received at least one injection of study treatment and who had a MAS score in the GSC assessed both at baseline and at Week 4.||units on a scale||95% Confidence Interval|Least Squares Mean
831841|NCT01243320|Primary|Change In Mean Corpuscular Hemoglobin Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days|||pg||95% Confidence Interval|Mean
831775|NCT01249417|Primary|Change in MAS Score in the Gastrocnemius-soleus Complex (GSC) at the Ankle Joint of the (Most) Affected Lower Limb|The MAS is a 6-point scale which measures the intensity of muscle tone by measuring the resistance of the muscle to passive lengthening or stretching. Investigator will grade muscle tone in the GSC from 0 (no increase in tone) to 4 (affected parts rigid in flexion or extension).|Change from baseline to Week 4|ITT population, defined as all randomised subjects who received at least one injection of study treatment and who had a MAS score in the GSC assessed both at baseline and at Week 4.||units on a scale||95% Confidence Interval|Least Squares Mean
831776|NCT01249651|Secondary|Change in the Maximum Severity of Heartburn During the 7-day Period Prior to the 8 Week Visit (Visit 3) Compared to the Frequency of Heartburn During the 7-day Period Prior to Baseline (Visit 1)|"Maximum severity of heartburn during 7 days at baseline and at 8 weeks was obtained (None, Mild, Moderate, Severe). If the value at 8 weeks was better than at baseline in a participant, the participant was s categorized into Improved. If the value was same, then categorised into Unchanged. If the value was worsened, categorised into Worsened."|Baseline to 8 weeks|Full analysis set (96 participants)||Participants|||Number
831777|NCT01249651|Secondary|Change in the Maximum Severity of Heartburn During the 7-day Period Prior to the 4 Week Visit (Visit 2) Compared to the Frequency of Heartburn During the 7-day Period Prior to Baseline (Visit 1)|"Maximum severity of heartburn during 7 days at baseline and at 4 weeks was obtained (None, Mild, Moderate, Severe). If the value at 4 weeks was better than at baseline in a participant, the participant was s categorized into Improved. If the value was same, then categorised into Unchanged. If the value was worsened, categorised into Worsened."|Baseline and 4 weeks|92 Participants in the Full analysis set (96 participants) had data of heartburn at week 4.||Participants|||Number
831778|NCT01249651|Secondary|Change in the Frequency of Heartburn During the 7-day Period Prior to the 4 Week Visit (Visit 2) Compared to the Frequency of Heartburn During the 7-day Period Prior to Baseline (Visit 1)|The number of days with heartburn during the 7-day period prior to the 4 week visit (Visit 3) was compared to the number of days with heartburn during the 7-day period prior to baseline (Visit 1). The difference in the number of days with heartburn from baseline to 4 weeks was analysed.|Baseline and 4 weeks|92 Participants in the Full analysis set (96 participants) had data of heartburn.||Number of days||Standard Deviation|Mean
831779|NCT01249651|Primary|Change in the Frequency of Heartburn During the 7-day Period Prior to the 8 Week Visit (Visit 3) Compared to the Frequency of Heartburn During the 7-day Period Prior to Baseline (Visit 1)|The number of days with heartburn during the 7-day period prior to the 8 week visit (Visit 3) was compared to the number of days with heartburn during the 7-day period prior to baseline (Visit 1). The difference in the number of days with heartburn from baseline to 8 weeks was analysed.|Baseline to 8 weeks|Full analysis set (96 participants)||Number of days||Standard Deviation|Mean
831780|NCT01242514|Secondary|Mean HAQ-DI Score|HAQ-DI: Health Assessment Questionnaire - Disability Index, a measure of physical function. The HAQ-DI score is then calculated by summing the category scores from 8 sub-categories (ie, scores for patient ability in dressing and grooming, rising, eating, walking, hygiene, reach, grip and common daily activities) and dividing by the number of categories completed. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability. Number of participants are those with data at entry to this study (Week 0). As no imputation was applied, the numbers at subsequent visits are lower. bid = twice daily, qd = once daily|Weeks 0, 12, 24, 36 and 52|The full analysis set includes those patients who received at least 1 dose of investigational product, and were summarised according to treatment first received in this study (intention-to-treat principle).||Units on a scale||Standard Deviation|Mean
831781|NCT01242514|Secondary|Mean mTSS Score|mTSS: modified total sharp score, a measure of structural progression based upon X-rays. Hand and foot joints are scored for erosions and joint space narrowing and the results summed to give a value between 0 and 488. A higher value represents more serious progression of the disease. Number of participants are those with data at entry to this study (Week 0). As no imputation was applied, the numbers at subsequent visits are lower. bid = twice daily, N/A = not applicable, qd = once daily|Weeks 0 and 52|The full analysis set includes those patients who received at least 1 dose of investigational product, and were summarised according to treatment first received in this study (intention-to-treat principle).||Units on a scale||Standard Deviation|Mean
831782|NCT01242514|Primary|Percentage of Patients Who Had at Least 1 Adverse Event in Any Category|AE = adverse event, bid = twice daily, IP = investigational product, qd = once daily, SAE = serious adverse event|Entry in extension to end of study (variable duration; maximum 109 weeks)|The full analysis set includes those patients who received at least 1 dose of investigational product, and were summarised according to treatment first received in this study (intention-to-treat principle).||Percentage of patients|||Number
831783|NCT01242514|Secondary|Mean DAS28-CRP Score|DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patient's own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. Number of participants are those with data at entry to this study (Week 0). As no imputation was applied, the numbers at subsequent visits are lower. bid = twice daily, CRP = C-reactive protein, qd = once daily|Weeks 0, 12, 24, 36 and 52|The full analysis set includes those patients who received at least 1 dose of investigational product, and were summarised according to treatment first received in this study (intention-to-treat principle).||Units on a scale||Standard Deviation|Mean
831784|NCT01242527|Primary|Fasting Serum Triglycerides|The primary endpoints are the differences in mean percent changes from baseline to end-of-treatment in triglycerides between placebo and the 2g/day, 3g/day and 4g/day Epanova groups|12 weeks|The Intent-to-Treat (ITT) Population was comprised of all subjects who were randomized. In the event that randomized subjects terminated before treatment or had no post-treatment efficacy assessments, a modified ITT Population was implemented.||Percent change from baseline||95% Confidence Interval|Least Squares Mean
831785|NCT01242748|Secondary|Serum Levels of Prostate-specific Antigen (PSA) During 3 Years’ Treatment With Degarelix or Goserelin|Median PSA levels are presented as absolute values in nanograms per milliliter (ng/mL) at baseline and after 1, 6, 12, 19, and 22 months. One month equals 28 days. After 22 months, only a limited number of samples were analysed.|Baseline and after 1, 6, 12, 19, and 22 months|CS35 (NCT00946920)/CS35A Full Analysis Set (degarelix n=565; goserelin n=282). The analysis population was pre-specified in the study protocol and statistical analysis plan.||ng/mL||Full Range|Median
831786|NCT01242748|Secondary|Serum Levels of Testosterone During 3 Years’ Treatment With Degarelix or Goserelin|Median testosterone levels are presented as absolute values in nanograms per milliliter (ng/mL) at baseline and after 1, 6, 12, 19, and 22 months. One month equals 28 days. After 22 months, only a limited number of samples were analysed.|Baseline and after 1, 6, 12, 19, and 22 months|CS35 (NCT00946920)/CS35A Full Analysis Set (degarelix n=565; goserelin n=282). The analysis population was pre-specified in the study protocol and statistical analysis plan.||ng/mL||Full Range|Median
831787|NCT01242748|Secondary|Hazard Ratio of Mortality Rates During 3 Years’ Treatment Between Degarelix and Goserelin|The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of death.|From baseline to 3 years|CS35 (NCT00946920)/CS35A Full Analysis Set (degarelix n=565; goserelin n=282). The analysis population was pre-specified in the study protocol and statistical analysis plan.||percentage of deaths||95% Confidence Interval|Number
831788|NCT01242748|Secondary|Hazard Ratio of the Rates of Introduction of Additional Therapy Related to Prostate Cancer During 3 Years’ Treatment Between Degarelix and Goserelin|Additional therapy related to prostate cancer included radiation, anti-androgens and second-line treatment. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no additional therapy related to prostate cancer.|From baseline to 3 years|CS35 (NCT00946920)/CS35A Full Analysis Set (degarelix n=565; goserelin n=282). The analysis population was pre-specified in the study protocol and statistical analysis plan.||percentage of no additional therapy||95% Confidence Interval|Number
831789|NCT01242748|Secondary|Hazard Ratio of Testosterone Escape Rates During 3 Years’ Treatment Between Degarelix and Goserelin|Testosterone escape is defined as serum levels >0.5 ng/mL. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no testosterone escape.|From baseline to 3 years|CS35 (NCT00946920)/CS35A Full Analysis Set (degarelix n=565; goserelin n=282). The analysis population was pre-specified in the study protocol and statistical analysis plan.||percentage of no testosterone escape||95% Confidence Interval|Number
831790|NCT01242748|Secondary|Hazard Ratio of PSA Failure Rates During 3 Years Treatment Between Degarelix and Goserelin|PSA failure is defined as increase in serum PSA of 50%, and at least 5 ng/mL, compared to nadir, measured on two consecutive occasions at least 2 weeks apart. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no PSA failure.|From baseline to 3 years|CS35 (NCT00946920)/CS35A Full Analysis Set (degarelix n=565; goserelin n=282). The analysis population was pre-specified in the study protocol and statistical analysis plan.||percentage of no PSA failure||95% Confidence Interval|Number
831791|NCT01242748|Secondary|Hazard Ratio of PFS Failure Rates During 3 Years Treatment Between Degarelix and Goserelin|PFS failure is defined as either PSA failure, introduction of additional therapy related to prostate cancer (radiation, anti-androgens or second-line treatment), or death, whichever is first. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no PFS failure.|From baseline to 3 years|CS35 (NCT00946920)/CS35A Full Analysis Set (degarelix n=565; goserelin n=282). The analysis population was pre-specified in the study protocol and statistical analysis plan.||percentage of no PFS failure||95% Confidence Interval|Number
831792|NCT01242748|Primary|Hazard Ratio of Prostate-specific Antigen (PSA) Progression-free Survival (PFS) Failure Rates During 3 Years’ Treatment Between Degarelix and Goserelin|PSA PFS failure is defined as either PSA failure (defined as increase in serum PSA of 50%, and at least 5 ng/mL, compared to nadir, measured on two consecutive occasions at least 2 weeks apart) or death, whichever is first. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no PSA-PFS.|From baseline to 3 years|CS35 (NCT00946920)/CS35A Full Analysis Set (degarelix n=565; goserelin n=282). The analysis population was pre-specified in the study protocol and statistical analysis plan.||percentage of no PSA-PFS||95% Confidence Interval|Number
831793|NCT01242813|Secondary|Number of Participants With Anti-canakinumab Antibodies at Any Visit|Immunogenicity assessment included determination of anti-canakinumab (ACZ885) antibodies in serum samples using BIAcore system.|Day 1 up to Day 953 (End of study)|The analysis was performed on the FAS population.||Number of participants|||Number
831794|NCT01242813|Secondary|Serum Concentration of Total Interleukin-1β Antibody (IL-1β)|Pharmacodynamics of canakinumab was assessed by total IL-1β (sum of free and bound canakinumab) concentration, determined in serum by means of competitive Enzyme-linked immunosorbent assay (ELISA) with limit of detection at 0.25 picogram/milliliter (pg/mL).|Day 3, 8, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365, 393, 421, 449, 533, 561, 589, 617, 645, 673, 729, 785, 841, 897, 925 and 953|The analysis was performed on the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||pg/mL||Standard Deviation|Mean
831795|NCT01242813|Secondary|Serum Concentration of Canakinumab|Canakinumab concentrations in serum were assessed for evaluating pharmacokinetics of the drug.|Day 3, 8, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365, 393, 421, 449, 533, 561, 589, 617, 645, 673, 729, 785, 841, 897, 925 and 953|The analysis was performed on the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||microgram(s)/milliliter||Standard Deviation|Mean
831796|NCT01242813|Secondary|Percentage of Participants Who Relapsed and Received Rescue Medication|Participants who relapsed after the last dose of canakinumab and received either corticosteroid treatment or NSAID or both corticosteroid treatment and NSAID as rescue medication.|Day 85 to Day 953 (End of treatment period to End of study)|The analysis was performed on the FAS population.||Percentage of participants||95% Confidence Interval|Number
831797|NCT01242813|Secondary|Time to Relapse After Last Dose of Canakinumab|Relapse was defined as a Physician’s Global Assessment score of 2 (and an increase of at least 1 point compared to Day 15) and CRP and/or SAA ≥ 30 mg/L representing a 30% increase from Day 15.|Day 85 to Day 253 (End of treatment period to Follow-up period)|The analysis was performed on the FAS population.||Days||95% Confidence Interval|Median
831798|NCT01242813|Secondary|Percentage of Relapsed Participants|Relapse was defined as a Physician’s Global Assessment score of 2 (and an increase of at least 1 point compared to Day 15) and CRP and/or SAA ≥ 30 mg/L representing a 30% increase from Day 15.|Day 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365, 393, 421, 449,477,505, 533, 561, 589, 617, 645, 673,701, 729,757, 785, 813, 841,869, 897, 925 and 953|The analysis was performed on the FAS population.||Percentage of participants||95% Confidence Interval|Number
831842|NCT01243320|Primary|Change In Mean Corpuscular Volume Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 days|||fL||95% Confidence Interval|Mean
831799|NCT01242813|Secondary|Percentage of Participants With Defined Grades in Participant's Global Assessment Score|Participants assessed the disease condition based on a 5-point participant's global assessment scale based on TRAPS associated signs and symptoms as: 0 = None/absent; 1 = Minimal; 2 = Mild; 3 = Moderate; 4 = Severe.|Day 1 up to Day 253 (End of follow-up period)|"The analysis was performed on the FAS population. Here, Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure."||Percentage of participants|||Number
831800|NCT01242813|Secondary|Percentage of Participants With Defined Grades in Physician’s Global Assessment Score|Participants were assessed based by physician on Physician’s Global Assessment measured on a 5-point scale for TRAPS associated signs and symptoms as: 0 = None/absent; 1 = Minimal; 2 = Mild; 3 = Moderate; 4 = Severe.|Day 1 up to Day 953 (End of study)|"The analysis was performed on the FAS population. Here, Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure."||Percentage of participants|||Number
831801|NCT01242813|Secondary|Percentage of Participants With Defined Grades for Skin Rash, Eye Manifestations, Extremity Pain and Abdominal Pain|TRAPS signs and symptoms were assessed in 4 key categories: skin disease (skin rash), eye manifestations, extremity pain (musculoskeletal), and abdominal pain. Participants were assessed for TRAPS associated signs and symptoms a 5-point Physician’s global assessment scale: None/absent (no); 1 = Minimal; 2 = Mild; 3 = Moderate; 4 = Severe.|Day 113 (end of treatment period) up to Day 925 (End of study)|The analysis was performed on the FAS population.||Percentage of participants|||Number
831802|NCT01242813|Secondary|Percentage Change From Baseline in C-reactive Protein (CRP) and Serum Amyloid A (SAA) Concentration to End of Study|The CRP and SAA were used as inflammatory markers. The target level concentration was ≤ 10 mg/L. Negative percent change in concentration of inflammatory markers indicated improvement.|Day 1 up to Day 953 (End of study)|The analysis was performed on the FAS population.||Percent change||Full Range|Median
831803|NCT01242813|Secondary|Time to Participant's Assessed Clinical Remission|Time period for complete remission after initial canakinumab treatment as assessed by participants was defined as a participant's Global Assessment of TRAPS symptoms of scale 1 or less. The participant's Global Assessment was based on a 5-point scale: 0 = None/absent (no) ; 1 = Minimal; 2 = Mild; 3 = Moderate; 4 = Severe.|Baseline up to Day 15|The analysis was performed on the FAS population.||Days||95% Confidence Interval|Median
831804|NCT01242813|Secondary|Percentage of Participants With Complete or Almost Complete Response at Day 15 After Receiving Additional Dose at Day 8|Participants who had not achieved a complete response at Day 8 were given an additional dose of canakinumab. Complete response was defined as clinical remission (Physician’s Global Assessment of TRAPS activity absent or minimal) and serological remission (CRP and/or SAA < 10 mg/L). Almost complete response was defined as clinical remission and a partial serological remission (≥ 70% reduction of baseline CRP and/or SAA).|Day 15|"The analysis was performed on the FAS population. Here, Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure."||Percentage of participants||95% Confidence Interval|Number
831805|NCT01242813|Secondary|Time to Physician’s Assessed Clinical Remission|Time period for complete remission after initial canakinumab treatment as assessed by participants was defined as a Physician’s Global Assessment of TRAPS symptoms of scale 1 or less. The physician's Global Assessment was based on a 5-point scale: 0 = None/absent ; 1 = Minimal; 2 = Mild; 3 = Moderate; 4 = Severe.|Baseline up to Day 15|The analysis was performed on the FAS population.||Days||95% Confidence Interval|Median
831806|NCT01242813|Secondary|Percentage of Participant With Target Levels of C-reactive Protein (CRP) and Serum Amyloid A Protein (SAA) at Day 8 and 15|The CRP and SAA were used as inflammatory markers. The target level concentration was ≤ 10 mg/L.|Day 8 and Day 15|The analysis was performed on the FAS population.||Percentage of participants||95% Confidence Interval|Number
831807|NCT01242813|Secondary|Percentage of Participants With Complete Clinical Remission at Day 8 and 15|Complete clinical remission was defined as Physician’s Global Assessment of TRAPS activity to be absent or minimal (1). TRAPS associated clinical signs and symptoms were assessed by the investigator at every visit on a 5-point scale: 0 = Absent; 1 = Minimal; 2 = Mild; 3 = Moderate; 4 = Severe.|Day 8 and Day 15|The analysis was performed on the FAS population.||Percentage of participants||95% Confidence Interval|Number
831808|NCT01242813|Secondary|Percentage of Participants With Complete or Almost Complete Response at Day 8|Complete response was defined as clinical remission and serological remission. Clinical remission was defined as Physician’s Global Assessment of TRAPS activity absent or minimal and serological remission was defined as CRP and/or SAA < 10 mg/L. Almost complete response was defined as clinical remission and a partial serological remission (≥70% reduction of baseline CRP and/or SAA).|Day 8|The analysis was performed on the FAS population.||Percentage of participants||95% Confidence Interval|Number
831809|NCT01242813|Primary|Percentage of Participants With Complete or Almost Complete Response at Day 15|Complete response was defined as clinical remission and serological remission. Clinical remission was defined as Physician’s Global Assessment of TRAPS activity absent or minimal and serological remission was defined as C reactive protein (CRP) and/or Serum amyloid A protein (SAA) to be less than (<) 10 milligram per liter (mg/L). Almost complete response was defined as clinical remission and a partial serological remission (equal to or more than [≥] 70% reduction of baseline CRP and/or SAA).|Day 15|The primary analysis was performed on the Full Analysis Set (FAS), defined as all participants who received at least one dose of study treatment and had at least one post-baseline assessment for primary efficacy.||Percentage of participants||95% Confidence Interval|Number
831810|NCT01243112|Primary|Onset of Action|Time from infusion of local anesthetic to loss of sensation to sharp.|Up to 5 minutes|||second||Standard Deviation|Mean
831811|NCT01243112|Primary|Length of Action|The time from onset of local anesthesia until cessation of effect by sensation of sharp measured in 15 minute increments.|Up to 12 hours|A calculation was made to power the study appropriately to determine a difference of 5 minutes based on previous studies which did not include the use of epinephrine.||minutes||Standard Deviation|Mean
831843|NCT01243320|Primary|Change In Hematocrit Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days|||percent||95% Confidence Interval|Mean
831844|NCT01243320|Primary|Change In Hemoglobin Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days|||gm/dL||95% Confidence Interval|Mean
831845|NCT01243320|Primary|Change In Red Blood Count Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days|||m/uL||95% Confidence Interval|Mean
831818|NCT01243242|Secondary|Clinical Global Impression Scale (CGI-I)Score|"The CGI is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). CGI-I scores range from 1 (‘very much improved’) through to 7 (‘very much worse’).
During the conduct of the study, CGI-I evaluations were not done correctly and thus data interpretation is limited."|6 weeks from visit 1 baseline to visit 6|"The ITT population included all randomized subjects who completed at least one post-randomization visit.
During the conduct of the study, CGI-I evaluations were not done correctly and thus data interpretation is limited."||units on a scale||Standard Deviation|Mean
831819|NCT01243242|Secondary|Adult ADHD Quality of Life (AAQoL)- Measuring Change in Total Score of AAQoL From Visit 1 to Visit 6|The AAQoL scale provides a validated disease-specific measure of the impact of ADHD on quality of life.It is scored as an overall score (29 items) and four subscale scores: life productivity (11 items), psychological health (6 items), life outlook (7 items) and relationships (5 items). Individual items are scored on a five-point Likert-like scale from ‘Not at all/Never’ (1) to ‘Extremely/Very Often’ (5).|6 weeks (from visit 1 baseline to visit 6)|The ITT population included all randomized subjects who completed at least one post-randomization visit||units on a scale||Standard Deviation|Mean
831820|NCT01243242|Secondary|Test of Variables of Attention (TOVA) (Change in ADHD Score From Screening to Visit 6)|The TOVA is a computerized test that provides information about an individual's sustained attention, speed and consistency of responding, and behavioral self-regulation and executive functioning. ADHD score is a comparison of the subject's response to the CPT test to those of an ADHD group, and is reported as a Z-score. An ADHD score of -1.80 and less fits the profile of the ADHD sample. A score of more than -1.80 (more positive) does not fit the ADHD profile. When comparing ADHD scores the higher the ADHD score the better the performance.|6 weeks( visit 1 baseline to visit 6)|The ITT population included all randomized subjects who completed at least one post-randomization visit.||Z score||Standard Deviation|Mean
831846|NCT01243320|Primary|Change In White Blood Count Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days|||k/uL||95% Confidence Interval|Mean
831821|NCT01243242|Primary|Conners’ Adult ADHD Rating Scales (CAARS™)|The primary efficacy endpoint is the difference in change (decrease) in CAARS (Total ADHD Symptoms Score) between the study groups. The CAARS assess the presence and severity of ADHD symptoms and behaviors in adults. Respondents are asked to report their own experiences by rating items pertaining to their behavior/problems using a 4-point Likert-style format ranging from 0 (‘Not at all’, ‘never’) to 3 (‘Very much’, ‘very frequently’). The scale measures ADHD symptoms using a 30-item questionnaire.Total score is the sum of all the items ,min=30 Max=90|6 weeks (from visit 1 baseline to visit 6)|The ITT population included all randomized subjects who completed at least one post-randomization visit.||units on a scale||Standard Deviation|Mean
831822|NCT01243294|Secondary|Wear Time (Registered by Subject When Applying and Removing a Product)|Wear time was calculated from the time the subjects applied their product (date, year, time) to the time they detached the product (date, year, time). Wear time was estimated in hours per subject per base plate and mean value was calculated.|After each base plate change measured over a period of 10 +/- 2 days. Base plates are changed 1-6 times a day|"As this is a cross-over investigation 26 started at SS and crossed over to SenSura, and 28 started at SenSura and crossed to SS leading to a total population of 54 evaluating each medical device.
Population is ITT"||Hours|Participants|Standard Deviation|Mean
831823|NCT01243294|Secondary|Comfort (Subjects Own Assessment)|"Comfort where evaluated by subjects own assessment on a 5 point scale from very uncomfortable to very comfortable.
Results of participants who answered on own assessment of comfort of wearing the product on a 5 point scale (very uncomfortable, uncomfortable, acceptable, comfortable, very comfortable). Comfortable and very comfortable are the preferred end points and it is these results that are presented here.
Unit of measure is: Percentage of participants answering 'very comfortable' and 'comfortable'"|After each test period, i.e. after 10 (±2) days with one test product and after 10 (±2) days with the other test product|"As this is a cross-over investigation 26 started at SS and crossed over to SenSura, and 28 started at SenSura and crossed to SS leading to a total population of 54 evaluating each medical device.
Population is ITT"||Percent of participants|||Number
831824|NCT01243294|Secondary|Handling at Appliance (Subjects Own Assessment)|"Handling at appliance where evaluated by subjects own assessment on a 5 point scale from very difficult to very easy.
Results of participants who answered on own feeling of handling at appliance on a 5 point scale (very difficult, difficult, acceptable, easy, very easy). Easy and very easy are the preferred end points and it is the these results that are presented here.
Unit of measure is: Percentage of participants answering 'very easy' and 'easy'"|After each test period, i.e. after 10 (±2) days with one test product and after 10 (±2) days with the other test product|"As this is a cross-over investigation 26 started at SS and crossed over to SenSura, and 28 started at SenSura and crossed to SS leading to a total population of 54 evaluating each medical device.
Population is ITT"||Percent of participants|||Number
831825|NCT01243294|Secondary|Security (Subjects Own Assessment)|"Results of participants who answered on own assessment of security on a 5 point scale ('very poor', 'poor', 'acceptable', 'good' and 'very good'). 'Good' and 'very good' are the preferred end points The 'very good' result are presented here.
Unit of measure is: Percentage of participants answering 'very good'"|After each test period, i.e. after 10 (±2) days with one test product and after 10 (±2) days with the other test product|"As this is a cross-over investigation 26 started at SS and crossed over to SenSura, and 28 started at SenSura and crossed to SS leading to a total population of 54 evaluating each medical device.
Population is ITT"||Percent of participants|||Number
831826|NCT01243294|Secondary|Adverse Events|Safety is evaluated by adverse events occuring continues while the subjects are testing the devices|During the investigation ~ 24 days per subject|"As this is a cross-over investigation 26 started at SS and crossed over to SenSura, and 28 started at SenSura and crossed to SS leading to a total population of 54 evaluating each medical device.
Population is ITT"||Adverse events|||Number
831827|NCT01243294|Primary|Leakage (Percent of All Base Plates With Leakage)|Leakage is evaluated after each change of base plate on a 4-point scale from no leakage, leakage on the base plate, leakage soiling clothe and sudden leakage - the 3 last mentioned are all defined as leakage. No leakage is the preferred end point|After each base plate change measured over a period of 10 +/- 2 days. Base plates are changed 1-6 times a day|Intention to treat. As this is a cross-over investigation 26 started at SS and crossed over to SenSura, and 28 started at SenSura and crossed to SS leading to a total population of 54 evaluating each medical device||Percent of Base plates|Participants||Number
831828|NCT01243320|Primary|Change in Quinone Oxidoreductase 1 Gene|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days|||ng/mL||95% Confidence Interval|Mean
831829|NCT01243320|Primary|Change in Monocyte Chemotactic Protein 1|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days|||ng/mL||95% Confidence Interval|Mean
831830|NCT01243320|Primary|Change to Interleukin-1 Beta Receptor|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days|||ng/mL||95% Confidence Interval|Mean
831831|NCT01243320|Primary|Change to Interleukin-1 Alpha Receptor|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days|||ng/mL||95% Confidence Interval|Mean
831832|NCT01243320|Primary|Change to Interleukin-8 Receptor|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days|||ng/mL||95% Confidence Interval|Mean
831833|NCT01243320|Primary|Sputum Reactive Oxygen Species Change|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days|||uM||95% Confidence Interval|Mean
831834|NCT01243320|Primary|Change in Eosinophil Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days|||percent||95% Confidence Interval|Mean
831835|NCT01243320|Primary|Change in Basophils Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days|||percent||95% Confidence Interval|Mean
831836|NCT01243320|Primary|Change In Monocytes Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days|||percent||95% Confidence Interval|Mean
831837|NCT01243320|Primary|Change In Lymphocytes Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days|||percent||95% Confidence Interval|Mean
831838|NCT01243320|Primary|Change In Granulocytes Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days|||percent||95% Confidence Interval|Mean
831839|NCT01243320|Primary|Change In Platelet Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days|||k/uL||95% Confidence Interval|Mean
831865|NCT01243411|Secondary|A Composite Responder Analysis Based on Change From Baseline in Penile Curvature and in the Peyronie's Disease Bother Score|"A composite responder is indicated by
a percent reduction from baseline in penile curvature greater than or equal to the threshold, and
a reduction from baseline in Peyronie's disease bother score greater than or equal to the threshold, or change in the overall sexual activity within the last 3 months to having vaginal intercourse from no vaginal intercourse at screening."|Week 36|Composite responder analysis is based on the intent-to-treat (ITT) population.||participants|||Number
831866|NCT01243411|Secondary|Change From Baseline in Penile Plaque Consistency|Penile plaque consistency score range 1 (non-palpable) to 5 (hard). A decrease in the change from baseline in penile plaque consistency is indicated by a negative number.|Baseline and Week 36|Efficacy is based on the mITT population.||units on a scale||Standard Deviation|Mean
831867|NCT01243411|Secondary|Change in the Overall Satisfaction Domain of the International Index of Erectile Function (IIEF)|Overall satisfaction domain of the IIEF score range 0 to 5 on 2 questions where higher scores indicate improved function or satisfaction; total score range 0 to 10.|Baseline and Week 36|Efficacy is based on the mITT population.||units on a scale||Standard Deviation|Mean
831868|NCT01243411|Secondary|A Responder Analysis Based on Subject Overall Global Assessment|Subject overall global assessment of Peyronie's disease score range -3 (much worse) to 3 (much improved). A score of 1 (improved in a small but important way), 2 (moderately improved), or 3 indicate a responder.|Week 36|Efficacy is based on the mITT population.||participants|||Number
831869|NCT01243411|Secondary|Change From Baseline in the Penile Pain Domain of the PDQ in Subjects With Baseline Penile Pain Score ≥4|Penile pain scale range 0 (no pain) to 10 (extreme pain) on 3 questions; total score range 0 to 30. A decrease in the change from baseline total score in the penile pain domain of the PDQ is indicated by a negative number. Subjects were required to have a penile pain score of 4 or greater at baseline.|Baseline and Week 36|Efficacy is based on the mITT population; this population only includes those subjects in the mITT population with a baseline penile pain score of 4 or greater.||units on a scale||Standard Deviation|Mean
831870|NCT01243411|Secondary|Change From Baseline in the Severity of Peyronie's Disease Symptoms Domain of the PDQ|Peyronie's disease symptoms (physical and psychological) severity score range 0 (none) to 4 (very severe) on 6 questions; total score range 0 to 24. A decrease in the change from baseline total score in the Peyronie's disease symptoms domain of the PDQ is indicated by a negative number.|Baseline and Week 36|Efficacy is based on the mITT population.||units on a scale||Standard Deviation|Mean
831871|NCT01243411|Primary|Change From Baseline in the Peyronie's Disease Bother Domain of the Peyronie's Disease Questionnaire (PDQ)|Peyronie's disease bother score range 0 (no issue or not at all bothered) to 4 (extremely bothered) on 4 questions; total score range 0 to 16. A decrease in the change from baseline total score in the Peyronie's disease bother domain of the PDQ is indicated by a negative number.|Baseline and Week 36|Efficacy is based on the mITT population.||units on a scale||Standard Deviation|Mean
831872|NCT01243411|Primary|Percentage Change From Baseline in Penile Curvature|A negative value in the percentage change from baseline in penile curvature deformity (angle measured in degrees) indicates less curvature.|Baseline and Week 36|Efficacy is based on the modified intent-to-treat (mITT) population.||percentage of curvature change||Standard Deviation|Mean
831873|NCT01243450|Primary|Acne Lesion Percent Reduction|Reduction in number of Acne lesions by counting over 12 weeks|12 week|||percent reduction of number of lesions||Standard Deviation|Mean
831874|NCT01243567|Secondary|Absolute Difference Between Patient's Lowest IOP Reading at Baseline (Day 0) and the Corresponding IOP Reading|IOP is a measurement of the fluid pressure inside the eye. Two or three measurements of IOP are taken for each eye at each time point. The lowest IOP values between the two eyes for each patient at each time point are used to calculate the absolute difference.|Baseline, Month 3|Intent to Treat: all randomized patients.||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
831875|NCT01243567|Secondary|Absolute Difference Between Patient's Highest IOP Reading at Baseline (Day 0) and the Corresponding IOP Reading|IOP is a measurement of the fluid pressure inside the eye. Two or three measurements of IOP are taken for each eye at each time point. The highest IOP values between the two eyes for each patient at each time point are used to calculate the absolute difference.|Baseline, Month 3|Intent to Treat: all randomized patients.||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
831876|NCT01243567|Secondary|Percentage of Patients Reaching a Predefined Target Pressure Threshold|IOP is a measurement of the fluid pressure inside the eye. For each patient, the IOP is the average of the two eyes. The predefined target pressure thresholds are at least a 20%, 30%, 40%, and 50% reduction in IOP from baseline.|Baseline, Month 3|Intent to Treat: all randomized patients.||Percentage of Patients|||Number
831877|NCT01243567|Secondary|Change From Baseline IOP|IOP is a measurement of the fluid pressure inside the eye. For each patient, the IOP is the average of the two eyes. IOP is recorded at the 08:00 (8:00 am), 12:00 (noon) and 16:00 (4:00 pm) hour time points for each patient at each visit. A negative number change from Baseline indicates a reduction in IOP (improvement).|Baseline, Month 3|Intent to Treat: all randomized patients.||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
831878|NCT01243567|Primary|Change From Baseline in Average Intraocular Pressure (IOP)|IOP is a measurement of the fluid pressure inside the eye. For each patient, the IOP is the average of the two eyes. The average IOP is the average of the 08:00, 12:00 and 16:00 hour time points at each visit for each patient. A negative number change from Baseline indicates a reduction in average IOP (improvement).|Baseline, Month 3|Intent to Treat: all randomized patients.||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
831879|NCT01243619|Other Pre-specified|Analyze Correlation Between FDG and FLT PET Scans, and the Correlation Between Both Types of PET Scan and the Response to Treatment.|We will compare the findings of FDG and FLT PET scans at pre-treatment, mid-treatment and post-treatment time points to determine how closely they correlate with each other, and if there is a specific time point at which any observed differences between FDG and FLT PET scans are most pronounced. We will also determine which of the six PET scans may correlate most closely with the response to treatment as determined by pathologic findings at esophagectomy.|1 year||||||
831955|NCT01251354|Secondary|Determination of Time to Progression (TTP) in This Patient Population|Time to Progression (TTP): Time from first study treatment to first documentation of objective tumour progression.|After the last enrolled patient has been followed for at least 6 months or has progressed or died|The study was terminated early and due to the low number of patients enrolled, data was not collected/analysed for this endpoint|||||
831880|NCT01243619|Primary|Feasibility: Determined by the Number of Participants Who Had All Three Sets of Completed Serial PET Scans That Were Imported for Analysis|Determine the possibility of aquiring three sets of serial Positron emission tomography (PET) scans from 5 patients at designated time points and to develop a mechanism to import and analyze images from F-fluoro-3'-deoxy-3'-L-fluorothymidine (FLT)-PET, Fluorodeoxyglucose(FDG)-PET and Computed Tomography (CT) on a single advanced software platform with deformable image registration capability. We will report patient acceptance of and compliance with this regimen, as well as the utility of the software platform for conducting the proposed analysis.|1 year|||participants|||Number
831881|NCT01243671|Secondary|Median Change From Baseline in C-Reactive Protein (CRP) at Week 24 and Week 52|C-Reactive Protein (CRP) normal range was defined as ≤0.3 mg/dL.|Baseline, 24 weeks, 52 weeks|Full analysis set (all participants). Those with missing evaluations were imputed by last observation carried forward.||mg/dL||Standard Deviation|Mean
831882|NCT01243671|Secondary|Mean Change From Baseline in Short Form-36 (SF-36) Summary Scores at Week 24 and Week 52|The Short-Form-36 (SF-36) Health Survey is a comprehensive quality of life scale. An increase in SF-36 score indicates alleviation of the disease and a decrease in score indicates aggravation of disease. The physical component reflects activity level, activity limitations, pain and rating of one's health. Score on the physical component ranges from 0 (poorest health) to 100 (best health). The mental component reflects vitality, social functioning, role-emotional and mental health. Score on the mental component ranges from 0 (poorest health) to 100 (best health).|Baseline, 24 weeks, 52 weeks|Full analysis set (all participants). Those with missing evaluations were imputed by last observation carried forward.||units on a scale||Standard Deviation|Mean
831883|NCT01243671|Secondary|Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 24 and Week 52|Inflammatory Bowel Disease Questionnaire (IBDQ) is the standard questionnaire to assess the quality of life of patients with inflammatory bowel disease. The IBDQ is a 32-item questionnaire consisting of 4 dimensions: bowel-related symptoms, systemic function, social function and emotional status. The responses to each question within each domain range from 1 (significant impairment) to 7 (no impairment), with total score ranging from 32 (very poor) to 224 (perfect health-related quality of life).|Baseline, 24 weeks, 52 weeks|Full analysis set (all participants). Those with missing evaluations were imputed by last observation carried forward.||units on a scale||Standard Deviation|Mean
831884|NCT01243671|Secondary|Number of Participants With Resolution of Behçet's Disease Symptoms (Other Than Gastrointestinal Symptoms) at Week 24 and Week 52|Investigators assessed oral aphthous (mouth ulcers), skin symptoms, eye symptoms and vulval (genital) ulcers during 4 weeks before study visit via participant interview, using the following grades. Oral aphthous: 0=None; 1=Symptom existed less than 2 weeks in recent 4 weeks; 2=Symptom existed 2 weeks or more in recent 4 weeks; 3=Symptom existed mostly in recent 4 weeks. Skin (Erythema nodosum rash): 0=None; 1=Symptom existed less than 2 weeks in recent 4 weeks; 2=Symptom existed 2 weeks or more in recent 4 weeks; 3=Symptom existed mostly in recent 4 weeks. Eye (Uveitis): 0=None; 1=one eye crisis in recent 4 weeks; 2=two eye crises in recent 4 weeks; 3=three eye crises in recent 4 weeks. Vulval (genital) ulcer: 0=None; 1=Symptom existed less than 2 weeks in recent 4 weeks; 2=Symptom existed 2 weeks or more in recent 4 weeks; 3=Symptom existed mostly in recent 4 weeks. Resolution was defined as: Behçet's disease symptoms other than gastrointestinal symptoms were graded 0 (disappeared).|24 weeks, 52 weeks|Full analysis set (all participants). n=number of participants who had any symptom at baseline. Those with missing evaluations were imputed as non-responders.||participants|||Number
831885|NCT01243671|Secondary|Number of Participants With Abdominal Pain, Diarrhea and Other Gastrointestinal (GI) Symptoms Grade ≤1 and Improvement of ≥1 Grade at Week 24 and Week 52|Participants assessed their abdominal pain, diarrhea and other gastrointestinal symptoms (abdominal discomfort, abdominal fullness, etc) during 2 weeks before assessment visit in 5 grades. Investigator confirmed the assessment through interview with participants. Assessment is graded from 0 to 4: 0=free of symptoms; 1=symptoms existed in past 2 weeks but did not affect participant’s daily life; 2=symptoms existed in past 2 weeks and slightly affected participant’s daily life; 3=symptoms existed in past 2 weeks and affected participant’s daily life; 4=symptoms existed in past 2 weeks and critically affected participant’s daily life. Improvement of ≥1 grade from baseline is also presented.|24 weeks, 52 weeks|Full analysis set (all participants). n=number of participants who had any symptom at baseline. Those with missing evaluations were imputed as non-responders.||participants|||Number
831886|NCT01243671|Secondary|Number of Participants With Endoscopic Improvement Grades 0, ≤1 and ≤2 at Week 24 and Week 52|Endoscopic improvement was assessed in 4 grades compared to the screening (baseline) endoscopy based on the longest diameter (none, ≥1 cm to <2 cm, ≥2 cm to <3 cm, ≥3 cm) of ileocecal largest open ulcer (area of mucosal defect). Grades are: 0=healing; 1=marked reduction (reduction to ≤1/4); 2=reduction (reduction to ≤1/2 - 1/4); 3=no change or worse (reduction less than 1/2 or expansion).|24 weeks, 52 weeks|Full analysis set (all participants). Those with missing evaluations were imputed as non-responders.||participants|||Number
831887|NCT01243671|Secondary|Number of Participants With a Global Assessment of Gastrointestinal Symptoms Grade 0 or ≤1 and Improvement of ≥1 Grade at Week 24 and Week 52|Study participants completed a global assessment of their gastrointestinal symptoms (Behçet’s disease symptoms other than gastrointestinal symptoms were excluded) during 2 weeks before assessment visit on a 5-grade scale. The investigator confirmed this assessment via interview with participants. Assessment is graded from 0 to 4: 0=free of symptoms; 1=symptoms existed in past 2 weeks but did not affect participant’s daily life; 2=symptoms existed in past 2 weeks and slightly affected participant’s daily life; 3=symptoms existed in past 2 weeks and affected participant’s daily life; 4=symptoms existed in past 2 weeks and critically affected participant’s daily life. Global assessment of grade 0 or ≤1 and improvement of ≥1 (from baseline) is presented.|24 weeks, 52 weeks|Full analysis set (all participants). Those with missing evaluations were imputed as non-responders.||participants|||Number
831904|NCT01249664|Secondary|Percentage of Participants Who Lost at Least 10 Letters in BCVA at Week 48 - LOCF|Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.|Baseline, Week 48|||Percentage of participants|||Number
831956|NCT01251354|Secondary|Number of Participants With Adverse Events||Up to 28 days after last dose|All Screened Population||participants|||Number
831888|NCT01243671|Secondary|Number of Participants With Complete Remission at Week 24 and Week 52|Complete remission was defined as both endoscopic improvement and global assessment of gastrointestinal symptoms grades of 0. Endoscopic improvement was assessed in 4 grades compared to the screening (baseline) endoscopy based on the longest diameter (none, ≥1 cm to <2 cm, ≥2 cm to <3 cm, ≥3 cm) of ileocecal largest open ulcer (area of mucosal defect). Grades are: 0=healing; 1=marked reduction (reduction to ≤1/4); 2=reduction (reduction to ≤1/2 - 1/4); 3=no change or worse (reduction less than 1/2 or expansion). Global assessment of gastrointestinal symptoms is a participant-assessed, investigator-confirmed grading of global symptoms from 0 to 4: 0=free of symptoms; 1=symptoms existed in past 2 weeks but did not affect participant's daily life; 2=symptoms existed in past 2 weeks and slightly affected participant's daily life; 3=symptoms existed in past 2 weeks and affected participant's daily life; 4=symptoms existed in past 2 weeks and critically affected participant's daily life.|24 weeks, 52 weeks|Full analysis set (all participants). Those with missing evaluations were imputed as non-responders.||participants|||Number
831889|NCT01243671|Secondary|Number of Participants With Marked Improvement at Week 52|Marked improvement is defined as the combination of both global assessment of gastrointestinal (GI) symptoms and endoscopic improvement grades of ≤1. Global assessment of GI symptoms is a participant-assessed, investigator-confirmed grading of global symptoms from 0 to 4: 0=free of symptoms; 1=symptoms existed in past 2 weeks but did not affect participant’s daily life; 2=symptoms existed in past 2 weeks and slightly affected participant’s daily life; 3=symptoms existed in past 2 weeks and affected participant’s daily life; 4=symptoms existed in past 2 weeks and critically affected participant’s daily life. Endoscopic improvement was assessed in 4 grades compared to the screening endoscopy based on the longest diameter (none, ≥1 cm to <2 cm, ≥2 cm to <3 cm, ≥3 cm) of ileocecal largest open ulcer (area of mucosal defect). Grades are: 0=healing; 1=marked reduction (reduction to ≤1/4); 2=reduction (reduction to ≤1/2 - 1/4); 3=no change or worse (reduction less than 1/2 or expansion).|52 weeks|Full analysis set (all participants). Those with missing evaluations were imputed as non-responders.||participants|||Number
831890|NCT01243671|Primary|Number of Participants With Marked Improvement at Week 24|Marked improvement is defined as the combination of both global assessment of gastrointestinal (GI) symptoms and endoscopic improvement grades of ≤1. Global assessment of GI symptoms is a participant-assessed, investigator-confirmed grading of global symptoms from 0 to 4: 0=free of symptoms; 1=symptoms existed in past 2 weeks but did not affect participant’s daily life; 2=symptoms existed in past 2 weeks and slightly affected participant’s daily life; 3=symptoms existed in past 2 weeks and affected participant’s daily life; 4=symptoms existed in past 2 weeks and critically affected participant’s daily life. Endoscopic improvement was assessed in 4 grades compared to the screening endoscopy based on the longest diameter (none, ≥1 cm to <2 cm, ≥2 cm to <3 cm, ≥3 cm) of ileocecal largest open ulcer (area of mucosal defect). Grades are: 0=healing; 1=marked reduction (reduction to ≤1/4); 2=reduction (reduction to ≤1/2 - 1/4); 3=no change or worse (reduction less than 1/2 or expansion).|24 weeks|Full analysis set (all participants). Those with missing evaluations were imputed as non-responders.||participants|||Number
831891|NCT01243775|Secondary|Neutropenia Grade 3-4|Toxicity (CECAE ver 4.0) and Safety|2 years|||participants|||Number
831892|NCT01243775|Secondary|Overall Survival||2 years|||months||95% Confidence Interval|Median
831893|NCT01243775|Secondary|Progression Free Survival||2 years|||months||95% Confidence Interval|Median
831894|NCT01243775|Primary|Response Rate|RECIST version 1.1|6th week|Intention to treat population||participants|||Number
831895|NCT01249664|Secondary|Mean Change in Area of Leakage From Baseline at Week 24 - LOCF|A negative change from baseline indicates improvement, ie, less leakage.|Baseline, Week 24|||Disc areas||Standard Deviation|Mean
831896|NCT01249664|Secondary|Percentage of Participants Who Were Withdrawn From Study Drug During the First 24 Weeks||Baseline, Week 24|||Percentage of participants|||Number
831897|NCT01249664|Secondary|Mean Change in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Total Score From Baseline to Week 24 - LOCF|The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales which are all scored from 0-100. To reach the overall composite score, each sub-scale score is averaged in order to give each sub-scale equal weight.|Baseline, Week 24|||Scores on a scale||Standard Deviation|Mean
831898|NCT01249664|Secondary|Mean Change in European Five-dimensional Health Scale (EQ-5D) Score From Baseline to Week 24 - LOCF|EQ-5D is a quality of life questionnaire based on a scale from -0.594 (worst) to 1.00 (best).|Baseline, Week 24|||Scores on a scale||Standard Deviation|Mean
831899|NCT01249664|Secondary|Mean Change in Choroidal Neovascularization (CNV) Lesion Size as Assessed by Fluorescein Angiography (FA) From Baseline to Week 48 - LOCF|CNV area values measured in square millimeters, each disc area is equivalent to 2.54 mm^2 on the retina; lower values represent better outcomes|Baseline, Week 48|||Disc areas||Standard Deviation|Mean
831900|NCT01249664|Secondary|Mean Change in Choroidal Neovascularization (CNV) Lesion Size as Assessed by Fluorescein Angiography (FA) From Baseline to Week 24 - LOCF|CNV area values measured in square millimeters, each disc area is equivalent to 2.54 mm^2 on the retina; lower values represent better outcomes|Baseline, Week 24|||Disc areas||Standard Deviation|Mean
831901|NCT01249664|Secondary|Mean Change in Central Retinal Thickness (CRT) as Assessed by Optical Coherence Tomography (OCT) From Baseline to Week 48 - LOCF|A negative number indicates improvement (reduced thickness).|Baseline, Week 48|||microns||Standard Deviation|Mean
831902|NCT01249664|Secondary|Mean Change in Central Retinal Thickness (CRT) as Assessed by Optical Coherence Tomography (OCT) From Baseline to Week 24 - LOCF|A negative number indicates improvement (reduced thickness).|Baseline, Week 24|||microns||Standard Deviation|Mean
831903|NCT01249664|Secondary|Percentage of Participants Who Lost at Least 5 Letters in BCVA at Week 48 - LOCF|Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.|Baseline, Week 48|||Percentage of participants|||Number
832128|NCT01253044|Secondary|Sheehan Disability Inventory|To determine if receiving ACT, as compared to PCT, is associated with reduced functional impairment at the end of treatment. The score used is an average (range 0-10) of completed items, with higher scores indicating greater disability.|Baseline and week 12|||units on a scale||Standard Deviation|Mean
831905|NCT01249664|Secondary|Percentage of Participants Who Lost at Least 15 Letters in BCVA at Week 48 - LOCF|Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.|Baseline, Week 48|||Percentage of participants|||Number
831906|NCT01249664|Secondary|Percentage of Participants Who Lost at Least 5 Letters in BCVA at Week 24 - LOCF|Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.|Baseline, Week 24|||Percentage of participants|||Number
831907|NCT01249664|Secondary|Percentage of Participants Who Lost at Least 10 Letters in BCVA at Week 24 - LOCF|Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.|Baseline, Week 24|||Percentage of participants|||Number
831908|NCT01249664|Secondary|Percentage of Participants Who Lost at Least 15 Letters in BCVA at Week 24 - LOCF|Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.|Baseline, Week 24|||Percentage of participants|||Number
831909|NCT01249664|Secondary|Percentage of Participants Who Gained at Least 5 Letters in BCVA at Week 48 - LOCF|Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.|Baseline, Week 48|||Percentage of participants|||Number
831910|NCT01249664|Secondary|Percentage of Participants Who Gained at Least 10 Letters in BCVA at Week 48 - LOCF|Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.|Baseline, Week 48|||Percentage of participants|||Number
831911|NCT01249664|Secondary|Percentage of Participants Who Gained at Least 15 Letters in BCVA at Week 48 - LOCF|Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.|Baseline, Week 48|||Percentage of participants|||Number
831912|NCT01249664|Secondary|Percentage of Participants Who Gained at Least 5 Letters in BCVA at Week 24 - LOCF|Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.|Baseline, Week 24|||Percentage of participants|||Number
831913|NCT01249664|Secondary|Percentage of Participants Who Gained at Least 10 Letters in BCVA at Week 24 - LOCF|Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.|Baseline, Week 24|||Percentage of participants|||Number
831914|NCT01249664|Secondary|Mean Change in Best Corrected Visual Acuity (BCVA) as Measured by ETDRS From Baseline to Week 24 - Observed Cases|Data as observed at visit, no carrying forward from latest observation if missing data at later time points. Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning.|Baseline, Week 24|||Letters correctly read||Standard Deviation|Mean
831915|NCT01249664|Secondary|Percentage of Participants Who Gained at Least 15 Letters in BCVA as Measured by ETDRS at Week 24 Using the LOCF Approach|Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.|Baseline, Week 24|||Percentage of participants|||Number
831916|NCT01249664|Primary|Mean Change in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) From Baseline to Week 24 - Last Observation Carried Forward (LOCF)|Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning.|Baseline, Week 24|||Letters correctly read||Standard Deviation|Mean
831917|NCT01249833|Other Pre-specified|Change in Mood Assessment|"Mood was assessed using the Bond-Lader 10 cm (100 mm) visual analogue scales for mood (16 scales in total); factored for alertness (mean of 9 scales), calmness (mean of 2 scales) and contentment (mean of 5 scales).
The range in score for each scale and for each factor (alertness, calmness and contentment) was 0 - 100 mm.
Each scale was anchored such that the lower the value, the better the mood."|Change from baseline at Day 4|All randomised subjects with data collected at both Baseline and Day 4. Baseline data was available for all randomized subjects in both groups; Day 4 data was available for 54 of 59 randomized subjects in the Oseltamivir Group (54 analysed) and for 58 of 63 randomized subjects in the Standard of Care Alone Group (58 analysed).||millimeter||Standard Error|Least Squares Mean
832022|NCT01251653|Secondary|Duration of Objective Response According to RECIST v1.1|Duration of objective response was the time from the first documented complete response or partial response to disease progression or death.|From the first documented complete response or partial response to the time of disease progression or death|TS for patients who experienced objective response.||Days||Standard Deviation|Mean
831918|NCT01249833|Secondary|Change in Processing Speed Assessment|"Processing speed assessed with the animal number decoding subtest
The lower the value, the better the processing speed"|Change from baseline at Day 4|All randomized subjects for whom data was collected at both Baseline and Day 4. Oseltamivr Group: Baseline data available for all randomized subjects (59); Day 4 data available for 54 subjects (54 analysed). Standard of Care Alone Group: Baseline data available for all randomized subjects (63); Day 4 data available for 58 subjects (58 analysed).||Millliseconds||Standard Error|Least Squares Mean
831919|NCT01249833|Secondary|Change in Working Memory Assessment|"Working memory assessed with the Dot Memory Test.
The higher the value, the better the working memory."|Change from baseline at Day 4|All randomised subjects with data collected at both Baseline and Day 4. Oseltamivir Group: Baseline values collected for all randomized subjects (59); Day 4 data available for 54 subjects (54 analysed). Standard of Care Alone Group: Baseline values collected for all randomized subjects (63); Day 4 data available for 58 subjects (58 analysed)||Number of correct answers||Standard Error|Least Squares Mean
831920|NCT01249833|Primary|Change in Attention Assessment|"Attention assessed using simple reaction time measured in milliseconds. Simple reaction time calculated as the mean of the following 2 sub-tests:
Reaction Time Subtest
Cued Reaction Time Subtest
The lower the value, the better the attention."|Change from baseline at Day 4|All randomised subjects for whom data was collected at both baseline and Day 4. Oseltamivir group: baseline data available for 58 of 59 randomised subjects and Day 4 data for 53 subjects (53 subjects analysed). Standard of Care Alone group: baseline data available for 61 of 63 subjects and Day 4 data for 55 subjects (55 subjects analysed).||milliseconds||Standard Error|Least Squares Mean
831921|NCT01249872|Secondary|Change From Baseline of Spirometric Values|Preoperatively, after a detailed demonstration, baseline spirometry measurements of forced vital capacity (FVC), forced expiratory volume in 1 s (FEV1) and peak expiratory flow rate (PEFR) were measured, using a bedside spirometer (PowerCubeΤΜ, Ganshorn Medizin Electronic, Germany), on-line connected to a PC. Spirometry was standardized with each patient in a 30o head-up position and it was performed at least three times and the best measurement was recorded, according to the criteria of the European Respiratory Society .Postoperatively, spirometric values (FVC= Forced Vital Capacity, FEV1=Forced Expiratory Volume at 1 sec , PEFR= Peak Expiratory Flow Rate)were recorded at 12, 24, 36, 48, 72, 144 hours . Data are expressed as percentage of preoperative values, which are 100%.|up to 6th day postoperatively|||percentage of preoperative values||Standard Deviation|Mean
831922|NCT01249872|Secondary|Cumulative Consumption of Epidural Morphine at 24h and 48h Postoperatively|Cumulative consumption of epidural morphine administered as loading dose, intraoperatively, of 1mg(groups B and E)or 2mg (groups C and F) and as continuous infusion of 0,2mg/h ( all groups) at 24h and 48h postoperatively.All participants in each Group received the same dose of epidural morphine, as no participant missed a scheduled dose.|up to 48 hours postoperatively|||mg||Standard Deviation|Mean
831923|NCT01249872|Secondary|Consumption of Levobupivacaine at 24h and 48 h Postoperatively|Cumulative consumption of levobupivacaine administered via patients controlled epidural analgesia pump( PCEA) at 24h and 48 h postoperatively|up to 48 hours postoperatively|||mg||Standard Deviation|Mean
831924|NCT01249872|Secondary|Time to First Postoperative Ambulation|Time to being able to walk without assistance within the room or outside the room|up to 6 days|||hours||Standard Deviation|Mean
831925|NCT01249872|Secondary|Time to Postoperative Bowel Recovery|Time to postoperative recovery of bowel function assessed by first flatus or stool, noticed by the patient|up to 6 days|||hours||Standard Deviation|Mean
831926|NCT01249872|Primary|Change From Baseline in Pain Scores (Visual Analogue Scale)|Pain scores at rest and on cough using a 10cm Visual Analogue Scale(0=no pain, 10=worst possible pain) were assessed up to 48h postoperatively.|up to 48 h postoperatively|The sample size was chosen in order to detect a difference in the epidural levobupivacaine PCEA consumption at 48 hrs. We calculated that 14 patients per group would be adequate to detect statistical significance (α = 0.05, power = 90%), using data from a previous pilot study Then, we increased the sample size by 15%.||units on a scale||Standard Deviation|Mean
831927|NCT01251120|Secondary|Change From Baseline to Months 6 and 12 in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score|HAQ-DI includes 20 questions concerning participant’s activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Overall score was computed as the sum of the domain scores and divided by the number of domains answered. Total possible score range was 0-3 where 0=without difficulties; 1= with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all.|Baseline and Months 6 and 12|Because of the limited number of participants (n=2), the study was terminated prematurely. No statistical analysis could be performed.|||||
831928|NCT01251120|Secondary|Change From Baseline to Months 6 and 12 in European Quality of Life-5D (EQ-5D) Score|EQ-5D is a participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline and Months 6 and 12|Because of the limited number of participants (n=2), the study was terminated prematurely. No statistical analysis could be performed.|||||
831929|NCT01251120|Secondary|Change From Baseline to Months 6 and 12 in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT F) Scores|The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participants fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). Clinically relevant improvement is defined as a ≥5-point change from Baseline.|Baseline and Months 6 and 12|Because of the limited number of participants (n=2), the study was terminated prematurely. No statistical analysis could be performed.|||||
831930|NCT01251120|Secondary|Percentage of Participants Achieving Remission at Months 6 and 12 Assessed Using Clinical Activity Disease Index (CDAI)|The CDAI is a purely clinical index to measure disease activity. The index includes swollen and tender joint counts, participant global assessment of disease activity, and evaluator global assessment of disease activity (EGA).|Months 6 and 12|Because of the limited number of participants (n=2), the study was terminated prematurely. No statistical analysis could be performed.|||||
831931|NCT01251120|Secondary|Percentage of Participants Achieving Responses According to American College of Rheumatology (ACR) Criteria|The ACR definition of response includes tender and swollen joint counts, VAS scales for pain, participant and investigator global assessment of disease activity, participant-assessed disability using Health Assessment Questionnaire (HAQ) and acute phase response.|Months 6 and 12|Because of the limited number of participants (n=2), the study was terminated prematurely. No statistical analysis could be performed.|||||
831932|NCT01251120|Secondary|Percentage of Participants Achieving Disease Remission at Month 6 Assessed Using DAS28|"The DAS28 is a combined index for measuring disease activity in RA. The index includes SJC and TJC, acute phase response, and general health status. For this study ESR was to be used to calculate DAS28 score. The DAS28, which uses a 28 joint count, is derived from the original DAS which includes a 44 swollen joint count. The DAS28 has been validated in RA. The index is calculated using the following formula:
DAS28 = 0.56 × √(TJC) + 0.28 × √(SJC) + 0.70 × ln(ESR) + 0.014 × GH Where, TJC28 = tender joint count on 28 joints, SJC28 = swollen joint count on 28 joints, ln = natural log, ESR measured as millimeters per hour (mm/hr), and GH = general health, which is participant’s global assessment of disease activity (100-mm VAS). DAS28 ≤ 2.6 defined remission."|Month 6|Because of the limited number of participants (n=2), the study was terminated prematurely. No statistical analysis could be performed.|||||
831933|NCT01251120|Secondary|Number of Hours Absent From Work|Work productivity measures include absence from work (participant reported and registries), permanent work disability (pension, participant reported and registries), presenteeism (Quantity and Quality instrument, QQ).|Baseline and 6 and 12 months|Because of the limited number of participants (n=2), the study was terminated prematurely. No statistical analysis could be performed.|||||
831934|NCT01251120|Primary|Percentage of Participants Achieving Disease Remission at Month 12 Assessed Using the Disease Activity Score Based on 28-Joint Count (DAS28)|"The DAS28 is a combined index for measuring disease activity in Rheumatoid Arthritis (RA). The index includes swollen and tender joint counts (SJC and TJC), acute phase response, and general health status. For this study Erythrocyte sedimentation Rate (ESR) was to be used to calculate DAS28 score. The DAS28, which uses a 28 joint count, is derived from the original DAS which includes a 44 swollen joint count. The DAS28 has been validated in RA. The index is calculated using the following formula:
DAS28 equals (=) 0.56 times (×) square root of √(TJC) plus (+) 0.28 × √(SJC) + 0.70 × ln(ESR) + 0.014 × GH Where, TJC28 = tender joint count on 28 joints, SJC28 = swollen joint count on 28 joints, ln = natural log, ESR measured as millimeters per hour (mm/hr), and GH = general health, which is participant’s global assessment of disease activity (100-mm Visual Analog Scale [VAS]). DAS28 less than/equal to (≤) 2.6 defined remission."|Month 12|Because of the limited number (n) of participants (n=2), the study was terminated prematurely. No statistical analysis could be performed.|||||
831935|NCT01251146|Secondary|Number of Participants Compliant With Study Treatment|Participants compliant with study treatment were the participants who have completed the study treatment regimen.|Baseline up to end of follow-up (Week 4 or Week 6 or Week 8)|ITT population included all randomized participants who received at least 1 dose of study medication.||participants|||Number
831936|NCT01251146|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: Any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition|Baseline up to end of follow-up (Week 4 or Week 6 or Week 8)|Safety population included all randomized participants who received at least 1 dose of study medication.||participants|||Number
831937|NCT01251146|Secondary|Percentage of Participants Attaining Heart Rate Goal at Week 2, 4 and 6|Heart rate goal was defined as attainment of heart rate less than or equal to 65 bpm.|Attainment of heart rate goal (Week 2 or Week 4 or Week 6)|ITT population included all randomized participants who received at least 1 dose of study medication.||percentage of participants|||Number
831938|NCT01251146|Secondary|Number of Participants Attaining Heart Rate Goal at Dosage 1, 2 and 3 of Study Treatment|Dosage 1, 2 and 3 for bisoprolol group was defined as 5 mg, 7.5 mg and 10 mg once daily and for atenolol group as 50 mg, 75 mg and 100 mg once daily, respectively. Heart rate goal was defined as attainment of heart rate less than or equal to 65 bpm.|Baseline up to attainment of heart rate goal (Week 2 or Week 4 or Week 6)|ITT population included all randomized participants who received at least 1 dose of study medication.||participants|||Number
831939|NCT01251146|Secondary|Change From Baseline in Ratio of Heart Rate Variability (HRV) for Low Frequency Power (LF) to Heart Rate Variability Power (HRV) for High Frequency (HF) (LF/HF) at Attainment of Heart Rate Goal and End of Follow-up|Heart rate variability (HRV) is used to describe the variations of both instantaneous HR and resting rate (RR) intervals and was evaluated for low frequency power (LF) and for high frequency power (HF). Heart rate goal was defined as attainment of heart rate less than or equal to 65 bpm.|Baseline, attainment of heart rate goal (Week 2 or Week 4 or Week 6) and end of follow-up (Week 4 or Week 6 or Week 8)|"ITT population included all randomized participants who received at least 1 dose of study medication. N signifies those participants who were evaluated for this measure. n signifies those participants who were evaluated for this measure at the specified time point for each treatment arm group respectively."||ratio||Standard Deviation|Mean
831954|NCT01251354|Secondary|Determination of Progression Free Survival (PFS) in This Patient Population|Progression Free Survival (PFS): Time from first study treatment until objective tumour progression or death from any cause.|After the last enrolled patient has been followed for at least 6 months or has progressed or died|The study was terminated early and due to the low number of patients enrolled, data was not collected/analysed for this endpoint|||||
832131|NCT01253070|Secondary|OS|OS was defined as the time from registration to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% confidence interval (CI) was estimated using the Kaplan Meier method.|Time from registration to death (up to 10 years)|||months||95% Confidence Interval|Median
831940|NCT01251146|Secondary|Change From Baseline in Heart Rate Variability (HRV) for Low Frequency Power (LF) and for High Frequency Power (HF) at Attainment of Heart Rate Goal and End of Follow-up|Heart rate variability (HRV) is used to describe the variations of both instantaneous HR and resting rate (RR) intervals and was evaluated for low frequency power (LF) and for high frequency power (HF). Heart rate goal was defined as attainment of heart rate less than or equal to 65 bpm.|Baseline, attainment of heart rate goal (Week 2 or Week 4 or Week 6) and end of follow-up (Week 4 or Week 6 or Week 8)|"ITT population included all randomized participants who received at least 1 dose of study medication. N signifies those participants who were evaluated for this measure. n signifies those participants who were evaluated for this measure at the specified time point for each treatment arm group respectively."||millisecond square (ms^2)||Standard Deviation|Mean
831941|NCT01251146|Primary|Change From Baseline in Baroreflex Sensitivity (BRS) at End of Follow-up|Baroreflex sensitivity (BRS) is an important characteristic of baroreflex control and often noninvasively assessed by relating heart rate (HR) fluctuations to blood pressure (BP) fluctuations. Heart rate goal was defined as attainment of heart rate less than or equal to 65 bpm.|Baseline and end of follow-up (Week 4 or Week 6 or Week 8)|"ITT population included all randomized participants who received at least 1 dose of study medication. N signifies those participants who were evaluated for this measure."||millisecond per millimeter of mercury||Standard Deviation|Mean
831942|NCT01251146|Primary|Change From Baseline in Baroreflex Sensitivity (BRS) at Attainment of Heart Rate Goal|Baroreflex sensitivity (BRS) is an important characteristic of baroreflex control and often noninvasively assessed by relating heart rate (HR) fluctuations to blood pressure (BP) fluctuations. Heart rate goal was defined as attainment of heart rate less than or equal to 65 beats per minute (bpm).|Baseline and attainment of heart rate goal (Week 2 or Week 4 or Week 6)|"Intention to treat (ITT) population included all randomized participants who received at least 1 dose of study medication. N signifies those participants who were evaluated for this measure. n signifies those participants who were evaluated for this measure at the specified time point for each treatment arm group respectively."||millisecond per millimeter of mercury||Standard Deviation|Mean
831943|NCT01251276|Secondary|Percentage of Participants With One or More Serious Adverse Experiences|A serious adverse experience is an adverse experience that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is a cancer, or may jeopardize the participant and may require medical or surgical intervention. The percentage of participants with one or more serious adverse experiences was assessed.|Up to Month 1 after challenge dose|Participants who received a challenge dose and had safety follow-up||Percentage of participants|||Number
831944|NCT01251276|Secondary|Percentage of Participants With One or More Systemic Adverse Experiences|The percentage of participants with one or more systemic adverse experiences was assessed.|Up to Day 15 after challenge dose|Participants who received a challenge dose and had safety follow-up||Percentage of participants|||Number
831945|NCT01251276|Secondary|Percentage of Participants With One or More Injection-site Adverse Experiences|The percentage of participants with one or more injection-site adverse experiences was assessed.|Up to Day 15 after challenge dose|Participants who received a challenge dose and had safety follow-up||Percentage of participants|||Number
831946|NCT01251276|Secondary|Percentage of Participants Who Discontinued the Study Due to an Adverse Experience|The percentage of participants who discontinued the study due to an adverse experience was assessed.|Up to Month 7|Participants who received a challenge dose and had safety follow-up||Percentage of participants|||Number
831947|NCT01251276|Secondary|Percentage of Participants With One or More Adverse Experiences|An adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor’s product, is also an adverse experience. The percentage of participants with one or more adverse experiences was assessed.|Up to Day 15 after challenge dose|Participants who received a challenge dose and had safety follow-up||Percentage of participants|||Number
831948|NCT01251276|Primary|Percentage of Seroresponders Before and After the Challenge Vaccination|A seroresponder was a participant with an anti-hepatitis B surface antibody titer >=10 milli Merck U/mL. The percentage of seroresponders was assessed before and after the challenge dose.|Predose (Day 1) and 1 month after challenge dose (Month 1)|Vaccinated participants with immunogenicity results, excluding those with protocol violations that might interfere with the immunogenicity evaluation||Percentage of participants||95% Confidence Interval|Number
831949|NCT01251315|Primary|Intracellular Glutathione Level|Mean intracellular glutathione level every 2 hour|6 hours|Intention-to-treat||µmol/L||Standard Deviation|Mean
831950|NCT01251315|Secondary|Augmentation Index|"Augmentation index (%) is defined as the percentage of the central pulse pressure which is attributed to the reflected pulse wave and, therefore, reflects the degree to which central arterial pressure is augmented by wave reflection if appropriate augmentation index has been shown to be a predictor of adverse cardiovascular events in a high risk patient populations,higher augmentation index is associated with target organ damage. Absolute change of augmentation index from baseline to 6 hours will be estimated for the analysis."|Baseline and 6 hours|||percentage of the central pulse pressure||Standard Deviation|Mean
831951|NCT01251354|Secondary|Determination of Overall Survival in This Patient Population|Overall Survival (OS): Defined as the time from first study treatment to death due to any cause.|2 years after the last patient enrolled|The study was terminated early and due to the low number of patients enrolled, data was not collected/analysed for this endpoint|||||
831952|NCT01251354|Secondary|Determination of Duration of Response in This Patient Population|Duration of Response (DR): Time from the first documentation of objective tumour response (defined as CR or PR) to the first documentation of objective tumour progression or death on study due to any cause.|After the last enrolled patient has been followed for at least 6 months or has progressed or died|The study was terminated early and due to the low number of patients enrolled, data was not collected/analysed for this endpoint|||||
831953|NCT01251354|Secondary|Determination of Overall Response Rate (ORR) in This Patient Population|Overall Response Rate (ORR): Defined as the sum of CR and PR.|After the last enrolled patient has been followed for at least 6 months or has progressed or died|The study was terminated early and due to the low number of patients enrolled, data was not collected/analysed for this endpoint|||||
831957|NCT01251354|Primary|Determination of Clinical Benefit (CB), Defined as Sum of Patients Who Present Complete Response (CR), Partial Response (PR) or Stable Disease (SD) ≥12 Weeks (CB=CR+PR+SD≥12 Weeks) Using Response Evaluation Criteria in Solid Tumors (RECIST Version1.1)|"CR defined as: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
PR defined as: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
SD defined as: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease (PD), taking as reference the smallest sum diameters while on study.
PD defined as: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression)."|12 weeks|The study was terminated early and due to the low number of patients enrolled, data was not collected/analysed for this endpoint|||||
831958|NCT01251380|Secondary|Mean Change From DB Baseline in the PedsQL Score (Generic Core Scores) at Each Study Visit Except Week 4|"The PedsQL is a validated quality of life questionnaire, designed for children from 2 to 18 years of age. The Generic Core Scale covers four multidimensional scales including physical, emotional, social and school aspects, with three summary scales of total scale score, physical health summary score and psychosocial health summary score.
Each generic core scale was calculated as follows: (1) Individual item scores were reversed and transformed from a 0-4 scale to a 0-100 scale by assigning 0=100, 1=75, 2=50, 3=25 and 4=0; (2) Each scale score was calculated as the sum of the transformed individual item scores, divided by the number of non-missing items. Higher scores indicated better quality of life (fewer symptoms or problems).
A scale score was only calculated if at least 50% of the associated items were non-missing."|Baseline and Week 12|ITT population where n represents number of subjects with data. For Treatment Cycle 4, Week 12 was not included in the study design. Subjects who completed the study or withdrew were counted as missing at subsequent visits. PHS = pyschosocial health summary; W12 = Week 12.||units on a scale||Standard Deviation|Mean
831959|NCT01251380|Secondary|Mean Change From DB Baseline in the PedsQL Score (CP Module Scores) at Each Study Visit Except Week 4|"The PedsQL has a disease specific CP module that is relevant to the study population and complements the core modules.
The 35-item questionnaire encompassed 7 scales including (1) daily activities (2) school activities (3) movement and balance (4) pain and hurt (5) fatigue (6) eating activities and (7) speech and communication. A 5-point scale was utilised for parent proxy-report: 0 = never a problem; 1 = almost never a problem; 2 = sometimes a problem; 3 = often a problem; 4 = almost always a problem.
Each CP score was calculated as follows: (1) Individual item scores were reversed and transformed from a 0-4 scale to a 0-100 scale by assigning 0=100, 1=75, 2=50, 3=25 and 4=0; (2) Each scale score was calculated as the sum of the transformed individual item scores, divided by the number of non-missing items. Higher scores indicated better quality of life (fewer symptoms or problems).
A scale score was only calculated if at least 50% of the associated items were non-missing."|Baseline and Week 12|ITT population where n represents number of subjects with data. For Treatment Cycle 4, Week 12 was not included in the study design. Subjects who completed the study or withdrew were counted as missing at subsequent visits.||units on a scale||Standard Deviation|Mean
831960|NCT01251380|Secondary|Mean Change From DB Baseline in the Observational Gait Scale (OGS) Total Score of the (Most) Affected Leg|"The OGS is a measurement tool used to objectively quantify positive and negative features (impairments) of the upper motor neurone syndrome. The OGS is useful when children are too young or insufficiently cooperative for instrumented gait analysis. It is based on the Physicians Rating Scale but has some modifications to improve its sensitivity to detect changes following administration of Botulinum Toxin Type A (BTX-A).
The OGS total score was calculated as the sum of the individual question scores for Questions 1 to 7, with the highest possible score being 20. The parameters collected were: knee position in midstance, initial foot contact, foot contact at midstance, timing of heel raise, hindfoot at midstance, base of support and gait assistive devices. Higher scores indicate better gait.
The mean change from baseline (in the DB study) in the OGS total score of the (most) affected leg was derived."|DB Baseline and Weeks 4 and 12 of Treatment Cycles 1 to 3; Week 4 of Treatment Cycle 4|ITT population where n represents number of subjects with data. For Dysport 10 U/kg and 15 U/kg, the actual administered doses in the GSC of the (most) affected leg were >7.5 to ≤12.5 U/kg and >12.5 to ≤17.5 U/kg, respectively. The analysis excluded subjects with doses ≤7.5 or >17.5 U/kg.||units on a scale||Standard Deviation|Mean
831961|NCT01251380|Secondary|Mean Change From Baseline (Prior to the First Injection Cycle in the Hamstrings) in Y Derived From the TS, in the Knee Flexors Assessed at the Knee Joint of the (Most) Affected Lower Limb|"The mean change from baseline (prior to the first injection cycle in the hamstrings) in Y was derived from the TS.
Y was graded according to the following scale: Grade 0 - no resistance throughout passive movement (best outcome); Grade 1 - slight resistance throughout passive movement; Grade 2 - clear catch at precise angle, interrupting passive movement, followed by release; Grade 3 - fatigable clonus (less than 10 sec when maintaining pressure) occurring at a precise angle, followed by release; Grade 4 - unfatigable clonus (more than 10 seconds when maintaining pressure) occurring at a precise angle; Grade 5 - joint immovable (worst outcome).
Catch without release was graded 0 if XV1=XV3, ‘unratable’ spasticity otherwise; catch with 'minimal' release was graded 2 if XV3 was consistent and consistently less than XV1.
Angle 0 = position of minimal stretch of the tested muscle. For Grades 0 and 1, spasticity angle X = 0 by definition."|Baseline and Weeks 4 and 12 of Treatment Cycles 1 to 3; Baseline and Week 4 of Treatment Cycle 4|ITT population where n represents number of subjects with data. For Dysport 5 U/kg and 10 U/kg, the actual administered doses in the hamstring of the (most) affected leg were >3 to ≤7.5 U/kg and >7.5 to ≤12.5 U/kg, respectively. Analysis excluded subjects with doses ≤3 or >12.5 U/kg. Only data from subjects injected in the hamstring are presented.||degrees||Standard Deviation|Mean
831997|NCT01251614|Secondary|Percentage of Participants Who Achieved a PASI 75 Response Over Time|"PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis).
A PASI 75 response is at least a 75% reduction (improvement) from Baseline in PASI score."|Baseline, Period A, Weeks 4, 8, and 11, Period C, Weeks 0 and 16, Period D, Weeks 0, 16, 28, 40 and 52|Non-responder imputation was used, the analysis was conducted in the ITT population.||percentage of participants|||Number
831962|NCT01251380|Secondary|Mean Change From Baseline (Prior to the First Injection Cycle in the Hamstrings) in X Derived From the TS, in the Knee Flexors Assessed at the Knee Joint of the (Most) Affected Lower Limb|"The TS was used to measure spasticity in the knee flexors at the knee joint of the (most) affected lower limb.
The Investigator assessed muscle reactions of the tested muscle to passive stretch at two velocities: SLOW = V1: as slow as possible (slower than the rate of natural drop of the limb segment under gravity); FAST = V2 (speed of the limb segment falling under gravity) or V3 (as fast as possible - faster than the rate of natural drop of the limb segment under gravity).
X (threshold) was derived as XV1 at slow speed minus XV3 at fast speed and the mean change from baseline (prior to the first injection cycle in the hamstrings) was calculated."|Baseline and Weeks 4 and 12 of Treatment Cycles 1 to 3; Baseline and Week 4 of Treatment Cycle 4|ITT population where n represents number of subjects with data. For Dysport 5 U/kg and 10 U/kg, the actual administered doses in the hamstring of the (most) affected leg were >3 to ≤7.5 U/kg and >7.5 to ≤12.5 U/kg, respectively. Analysis excluded subjects with doses ≤3 or >12.5 U/kg. Only data from subjects injected in the hamstring are presented.||degrees||Standard Deviation|Mean
831963|NCT01251380|Secondary|Mean Change From Baseline (Prior to the First Injection Cycle in the Hamstrings) in XV3 Derived From the TS, in the Knee Flexors Assessed at the Knee Joint of the (Most) Affected Lower Limb|"The TS was used to measure spasticity in the knee flexors at the knee joint of the (most) affected lower limb.
The Investigator assessed muscle reactions of the tested muscle to passive stretch at two velocities: SLOW = V1: as slow as possible (slower than the rate of natural drop of the limb segment under gravity); FAST = V2 (speed of the limb segment falling under gravity) or V3 (as fast as possible - faster than the rate of natural drop of the limb segment under gravity).
The mean change from baseline (prior to the first injection cycle in the hamstrings) in XV3 at fast speed was derived."|Baseline and Weeks 4 and 12 of Treatment Cycles 1 to 3; Baseline and Week 4 of Treatment Cycle 4|ITT population where n represents number of subjects with data. For Dysport 5 U/kg and 10 U/kg, the actual administered doses in the hamstring of the (most) affected leg were >3 to ≤7.5 U/kg and >7.5 to ≤12.5 U/kg, respectively. Analysis excluded subjects with doses ≤3 or >12.5 U/kg. Only data from subjects injected in the hamstring are presented.||degrees||Standard Deviation|Mean
831964|NCT01251380|Secondary|Mean Change From Baseline (Prior to the First Injection Cycle in the Hamstrings) in XV1 Derived From the TS, in the Knee Flexors Assessed at the Knee Joint of the (Most) Affected Lower Limb|"The TS was used to measure spasticity in the knee flexors at the knee joint of the (most) affected lower limb.
The Investigator assessed muscle reactions of the tested muscle to passive stretch at two velocities: SLOW = V1: as slow as possible (slower than the rate of natural drop of the limb segment under gravity); FAST = V2 (speed of the limb segment falling under gravity) or V3 (as fast as possible - faster than the rate of natural drop of the limb segment under gravity).
The mean change from baseline (prior to the first injection cycle in the hamstrings) in XV1 at slow speed was derived."|Baseline and Weeks 4 and 12 of Treatment Cycles 1 to 3; Baseline and Week 4 of Treatment Cycle 4|ITT population where n represents number of subjects with data. For Dysport 5 U/kg and 10 U/kg, the actual administered doses in the hamstring of the (most) affected leg were >3 to ≤7.5 U/kg and >7.5 to ≤12.5 U/kg, respectively. Analysis excluded subjects with doses ≤3 or >12.5 U/kg. Only data from subjects injected in the hamstring are presented.||degrees||Standard Deviation|Mean
831965|NCT01251380|Secondary|Mean Change From DB Baseline in Spasticity Grade (Y) Derived From the TS, in the GSC Assessed at the Ankle Joint of the (Most) Affected Lower Limb|"The mean change from baseline (in the DB study) in Y was derived from the TS.
Y was graded according to the following scale: Grade 0 - no resistance throughout passive movement (best outcome); Grade 1 - slight resistance throughout passive movement; Grade 2 - clear catch at precise angle, interrupting passive movement, followed by release; Grade 3 - fatigable clonus (less than 10 sec when maintaining pressure) occurring at a precise angle, followed by release; Grade 4 - unfatigable clonus (more than 10 seconds when maintaining pressure) occurring at a precise angle; Grade 5 - joint immovable (worst outcome).
Catch without release was graded 0 if XV1=XV3, ‘unratable’ spasticity otherwise; catch with 'minimal' release was graded 2 if XV3 was consistent and consistently less than XV1.
Angle 0 = position of minimal stretch of the tested muscle. For Grades 0 and 1, spasticity angle X = 0 by definition."|DB Baseline and Weeks 4 and 12 of Treatment Cycles 1 to 3; Week 4 of Treatment Cycle 4|ITT population where n represents number of subjects with data. For Dysport 10 U/kg and 15 U/kg, the actual administered doses in the GSC of the (most) affected leg were >7.5 to ≤12.5 U/kg and >12.5 to ≤17.5 U/kg, respectively. The analysis excluded subjects with doses ≤7.5 or >17.5 U/kg.||degrees||Standard Deviation|Mean
831966|NCT01251380|Secondary|Mean Change From DB Baseline in Spasticity Angle (X) Derived From the TS, in the GSC Assessed at the Ankle Joint of the (Most) Affected Lower Limb|"The TS was used to measure spasticity in the GSC at the ankle joint of the (most) affected lower limb.
The Investigator assessed muscle reactions of the tested muscle to passive stretch at two velocities: SLOW = V1: as slow as possible (slower than the rate of natural drop of the limb segment under gravity); FAST = V2 (speed of the limb segment falling under gravity) or V3 (as fast as possible - faster than the rate of natural drop of the limb segment under gravity).
X (threshold) was derived as XV1 at slow speed minus XV3 at fast speed and the mean change from DB baseline was calculated."|DB Baseline and Weeks 4 and 12 of Treatment Cycles 1 to 3; Week 4 of Treatment Cycle 4|ITT population where n represents number of subjects with data. For Dysport 10 U/kg and 15 U/kg, the actual administered doses in the GSC of the (most) affected leg were >7.5 to ≤12.5 U/kg and >12.5 to ≤17.5 U/kg, respectively. The analysis excluded subjects with doses ≤7.5 or >17.5 U/kg.||degrees||Standard Deviation|Mean
831967|NCT01251380|Secondary|Mean Change From DB Baseline in Angle of Catch (XV3) Derived From the TS, in the GSC Assessed at the Ankle Joint of the (Most) Affected Lower Limb|"The TS was used to measure spasticity in the GSC at the ankle joint of the (most) affected lower limb.
The Investigator assessed muscle reactions of the tested muscle to passive stretch at two velocities: SLOW = V1: as slow as possible (slower than the rate of natural drop of the limb segment under gravity); FAST = V2 (speed of the limb segment falling under gravity) or V3 (as fast as possible - faster than the rate of natural drop of the limb segment under gravity).
The mean change from DB baseline in XV3 at fast speed was derived."|DB baseline and Weeks 4 and 12 of Treatment Cycles 1 to 3; Week 4 of Treatment Cycle 4|ITT population where n represents number of subjects with data. For Dysport 10 U/kg and 15 U/kg, the actual administered doses in the GSC of the (most) affected leg were >7.5 to ≤12.5 U/kg and >12.5 to ≤17.5 U/kg, respectively. The analysis excluded subjects with doses ≤7.5 or >17.5 U/kg.||degrees||Standard Deviation|Mean
831968|NCT01251380|Secondary|Mean Change From DB Baseline in Angle of Arrest (XV1) Derived From the Tardieu Scale (TS), in the GSC Assessed at the Ankle Joint of the (Most) Affected Lower Limb|"The TS was used to measure spasticity in the GSC at the ankle joint of the (most) affected lower limb.
The Investigator assessed muscle reactions of the tested muscle to passive stretch at two velocities: SLOW = V1: as slow as possible (slower than the rate of natural drop of the limb segment under gravity); FAST = V2 (speed of the limb segment falling under gravity) or V3 (as fast as possible - faster than the rate of natural drop of the limb segment under gravity).
The mean change from DB baseline in XV1 at slow speed was derived."|DB baseline and Weeks 4 and 12 of Treatment Cycles 1 to 3; Week 4 of Treatment Cycle 4|ITT population where n represents number of subjects with data. For Dysport 10 U/kg and 15 U/kg, the actual administered doses in the GSC of the (most) affected leg were >7.5 to ≤12.5 U/kg and >12.5 to ≤17.5 U/kg, respectively. The analysis excluded subjects with doses ≤7.5 or >17.5 U/kg.||degrees||Standard Deviation|Mean
831969|NCT01251380|Secondary|Mean Goal Attainment Scale (GAS) Score|Individual goals were defined prior to treatment in each treatment period. The GAS is a functional scale used to measure progress towards individual therapy goals. Individual goals were defined for each subject by the physician, and the child's parents (caregiver) where applicable, prior to treatment. After treatment in each treatment cycle, the GAS for each goal was rated using a defined scale (-2: Much less than expected outcome, -1: Somewhat less than expected outcome, 0: Expected outcome, 1: Somewhat more than expected outcome, and 2: Much more than expected outcome).|Weeks 4 and 12 of Treatment Cycles 1 to 3; Week 4 of Treatment Cycle 4|ITT population where n represents number of subjects with data. For Dysport 10 U/kg and 15 U/kg, the actual administered doses in the GSC of the (most) affected leg were >7.5 to ≤12.5 U/kg and >12.5 to ≤17.5 U/kg, respectively. The analysis excluded subjects with doses ≤7.5 or >17.5 U/kg.||units on a scale||Standard Deviation|Mean
831970|NCT01251380|Secondary|Mean Physician’s Global Assessment (PGA) Score|Global assessment of treatment response based on changes since the first injection in the DB study. PGA Scale of the Treatment Response: Global assessment of treatment response was assessed by asking the Investigator the following question: “how would you rate the response to treatment in the subject’s lower limb(s) since the first injection in the DB study?” Answers were made on a 9 point rating scale (-4: markedly worse, -3: much worse, -2: worse, -1: slightly worse, 0: no change, +1: slightly improved, +2: improved, +3: much improved, +4: markedly improved).|Weeks 4 and 12 of Treatment Cycles 1 to 3; Week 4 of Treatment Cycle 4.|ITT population where n represents number of subjects with data. For Dysport 10 U/kg and 15 U/kg, the actual administered doses in the GSC of the (most) affected leg were >7.5 to ≤12.5 U/kg and >12.5 to ≤17.5 U/kg, respectively. The analysis excluded subjects with doses ≤7.5 or >17.5 U/kg.||units on a scale||Standard Deviation|Mean
831971|NCT01251380|Secondary|Mean Change From Baseline (Prior to the First Injection Cycle in Upper Limb Muscle Groups) in the Mean MAS Score for All Injected Upper Limb Muscle Groups From Treatment Cycle 2 Onwards|Baseline was defined as the value obtained prior to the first injection in the upper limb(s). The MAS is a 6-point scale which measures the intensity of muscle tone by measuring the resistance of the muscle to passive lengthening or stretching. The investigator graded muscle tone in the GSC from 0 (no increase in tone) to 4 (affected parts rigid in flexion or extension). No subjects were treated in the upper limb in Treatment Cycle 4.|Baseline and Weeks 4 and 12 of Treatment Cycles 2 and 3.|ITT population where n represents number of subjects with data. Only data from subjects injected in the upper limb muscle groups are presented. TC = Treatment Cycle.||units on a scale||Standard Deviation|Mean
831972|NCT01251380|Secondary|Mean Change From Baseline (Prior to the First Injection Cycle in the Hamstrings) in the MAS Score in the Knee Flexors Assessed at the Knee Joint of the (Most) Affected Lower Limb|Baseline was defined as the value obtained prior to the first injection in the hamstrings. The MAS is a 6-point scale which measures the intensity of muscle tone by measuring the resistance of the muscle to passive lengthening or stretching. The investigator graded muscle tone in the GSC from 0 (no increase in tone) to 4 (affected parts rigid in flexion or extension).|Baseline and Weeks 4 and 12 of Treatment Cycles 1 to 3; Baseline and Week 4 of Treatment Cycle 4.|ITT population where n represents number of subjects with data. For Dysport 5 U/kg and 10 U/kg, the actual administered doses in the hamstring of the (most) affected leg were >3 to ≤7.5 U/kg and >7.5 to ≤12.5 U/kg, respectively. Analysis excluded subjects with doses ≤3 or >12.5 U/kg. Only data from subjects injected in the hamstring are presented.||units on a scale||Standard Deviation|Mean
831973|NCT01251380|Secondary|Mean Change From Baseline (in the DB Study) in the MAS Score in the GSC Assessed at the Ankle Joint of the (Most) Affected Lower Limb|Baseline for the 'change from DB baseline' was defined as the baseline of Study 141 for all treatment cycles. The Modified Ashworth Scale (MAS) is a 6-point scale which measures the intensity of muscle tone by measuring the resistance of the muscle to passive lengthening or stretching. The investigator graded muscle tone in the GSC from 0 (no increase in tone) to 4 (affected parts rigid in flexion or extension).|DB baseline; Weeks 4 and 12 of Treatment Cycles 1 to 3; Week 4 of Treatment Cycle 4|Intent-to-treat (ITT) population where n represents number of subjects with data. For Dysport 10 U/kg and 15 U/kg, the actual administered doses in the GSC of the (most) affected leg were >7.5 to ≤12.5 U/kg and >12.5 to ≤17.5 U/kg, respectively, in the OL study. The analysis excluded subjects with doses ≤7.5 or >17.5 U/kg.||units on a scale||Standard Deviation|Mean
831974|NCT01251380|Primary|Number of Subjects With Treatment Emergent Adverse Events (TEAEs) Reported in the Double Blind (DB) + Open Label (OL) Period.|Adverse events (AEs) were monitored from the time of informed consent to the end of the study. All AEs were elicited by direct, non-leading questioning or by spontaneous reports.|From baseline (Day 1) until end of study (Week 40) of Cycle 1 and up to Week 28 of Cycles 2 to 4.|Safety Population - all enrolled subjects. One subject received placebo in the DB study and two treatment cycles of Dysport in the OL study. However, as both Dysport treatments were outside of the ranges specified (≤7.5 U/kg in Treatment Cycle 1 and Treatment Cycle 2), the subject was excluded from the analysis (no TEAEs reported for this subject).||participants|||Number
831975|NCT01251588|Secondary|Number of Participants Having Subsequent Surgical Procedures (SSPs) in Target Knee||Years 2 through 5 post treatment (MACI or microfracture)|||Participants|||Count of Participants
831976|NCT01251588|Secondary|Number of Participants Reporting Serious Adverse Events (SAEs)||Years 2 through 5 post treatment (MACI or microfracture)|||Participants|||Count of Participants
831977|NCT01251588|Secondary|Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs)||Years 2 through 5 post treatment (MACI or microfracture)|||Participants|||Count of Participants
831978|NCT01251588|Secondary|Change From MACI00206 Baseline in the European Quality of Life 5 Dimensions (EQ-5D) Visual Analog Scale (VAS) Score|The EQ-5D is a standardized instrument for use as a measure of health outcome (see the EuroQOL Website for details: www.euroqol.org). Applicable to a wide range of health conditions and treatments, it provides a simple descriptive profile and a single index value for health status. The EQ Visual Analogue Scale (VAS) was used to record the respondents’ self-rated health status on a vertical graduated (0-100) VAS where 0 is ‘the worst health you can imagine’ and 100 is ‘the best health you can imagine’.|MACI00206 Baseline and Week 260|65 of the 65 MACI-treated patients and 58 of the 63 microfracture-treated patients enrolled in MACI00809 completed the EQ-5D VAS Score at Week 260.||units on a scale||Full Range|Mean
831979|NCT01251588|Secondary|Change From MACI00206 Baseline in the 12-Item Short-Form Health Survey (SF-12) Physical and Mental Component Scores|"The SF-12 is a subset of the 36-Item Short–Form Health Survey (SF-36) and includes 8 subscales (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health) that are used to calculate the physical (PCS) and mental (MCS) summary component scores.
MCS and PCS are summarized as Z-scores using standard SF-12 scoring and a US population means. The Z-score indicates how many standard deviations a score is from the population mean. Higher values reflect better health. Changes from Baseline are reported."|MACI00206 Baseline and Week 260|65 of the 65 MACI-treated patients and 55 of the 63 microfracture-treated patients enrolled in MACI00809 completed the 12-Item Short-Form Health Survey at Week 260.||Z-score||Full Range|Mean
831980|NCT01251588|Secondary|Change From MACI00206 Baseline in the Patient's Evaluation of Overall Knee Condition Using the Modified Cincinnati Knee Rating System|The Modified Cincinnati Knee Rating System is a self-assessment of the intensity of sports participation, functional limitations, and the ability to participate in different types of sports. The Modified Cincinnati Knee Rating System overall knee condition score ranges from 1 (poor) to 10 (excellent).|MACI00206 Baseline and Week 260|65 of the 65 MACI-treated patients and 59 of the 63 microfracture-treated patients enrolled in MACI00809 completed the Modified Cincinnati Knee Rating System at Week 260.||units on a scale||Full Range|Mean
831981|NCT01251588|Secondary|Change From MACI00206 Baseline in the Patient's Evaluation of Overall Knee Condition Using the International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form|"The IKDC Subjective Knee Evaluation Form is a validated knee-specific measure of symptoms, function, and sports activity that is appropriate for patients with a wide variety of knee problems. The form consists of 18 items covering the domains of symptoms, functioning during activities of daily living and sports, and current function of the knee.
The IKDC Subjective Knee Evaluation Form is scored by summing the scores for the individual items and then transforming the score to a scale that ranges from 0 to 100. The transformed score is interpreted as a measure of function such that higher scores represent higher levels of function and lower levels of symptoms. A score of 100 is interpreted to mean no limitation with activities of daily living or sports activities and the absence of symptoms."|MACI00206 Baseline and Week 260|64 of the 65 MACI-treated patients and 59 of the 63 microfracture-treated patients enrolled in MACI00809 completed the IKDC form at Week 260.||units on a scale||Full Range|Mean
831982|NCT01251588|Secondary|Change From MACI00206 Baseline in the Remaining 3 Subscales (Activities of Daily Living, Quality of Life, and Other Symptoms) of KOOS|The KOOS is a validated knee-specific instrument developed to assess the patients' opinion of their knee and associated problems. KOOS consists of 5 subscales: Pain, Function in sports and recreational activities, other Symptoms, Function in activities of daily living (ADL), and knee related Quality of life (QOL). A 5-point Likert scale was used to record the response to each item ranging from 0 (no problems) to 4 (extreme problems). Within each subscale, items were added up and normalized to a value between 0 (extreme problems) and 100 (no problems). Subscales are not combined to calculate a total score.|MACI00206 Baseline and Week 260|Analysis population includes all participants who completed each KOOS subscale at Week 260.||units on a scale||Full Range|Mean
831983|NCT01251588|Secondary|Average Time to Treatment Failure|"ANALYSIS NOT DONE: The planned analyses concerning time to treatment failure were not conducted due to the small number of per protocol treatment failure cases. The number of per protocol treatment failures in each treatment group are reported here.
Patients were considered as a treatment failure if all of the following 5 criteria were met:
Patient’s global assessment of their knee joint compared to Baseline was the same or worse
Physician’s global assessment of the patient’s knee joint compared to Baseline was the same, worse, or significantly worse.
Percent improvement from Baseline in KOOS Pain score was less than 10%.
Physician diagnostic evaluation of failure excluded etiologies (eg, meniscal tear) other than failed treatment of the index lesion.
The physician decided that surgical re-treatment of the index lesion(s) was required that involved either extensive debridement for lesion expansion, violation of the subchondral bone, or ACI."|Up to 260 weeks|||Participants|||Count of Participants
831984|NCT01251588|Secondary|The Proportion of Patients in Each Treatment Group Assessed as Treatment Failures|"Patients were considered as a treatment failure if all of the following 5 criteria were met:
Patient's global assessment of their knee joint compared to Baseline was the same or worse
Physician's global assessment of the patient's knee joint compared to Baseline was the same, worse, or significantly worse.
Percent improvement from Baseline in KOOS Pain score was less than 10%.
Physician diagnostic evaluation of failure excluded etiologies (eg, meniscal tear) other than failed treatment of the index lesion.
The physician decided that surgical re-treatment of the index lesion(s) was required that involved either extensive debridement for lesion expansion, violation of the subchondral bone, or ACI."|Years 2 through 5 post treatment (MACI or microfracture)|||Participants|||Count of Participants
831985|NCT01251588|Secondary|Proportion of Patients Who Achieve at Least a 10-point Improvement From MACI00206 Baseline in KOOS Pain and Function (Sports and Recreational Activities) Scores|A responder is defined as a participant with at least a 10-point improvement in both the KOOS Pain and Function (Sports and Recreational activities) scores from MACI00206 Baseline scores.|Up to week 260|||Participants|||Count of Participants
831986|NCT01251588|Secondary|Magnetic Resonance Imaging (MRI) Assessments of Degree of Defect Fill|MRI was assessed by the independent blinded evaluators by means of consensus. The number of participants with a degree of defect fill of >50% is reported.|Week 260|all participants with an MRI at Week 260||Participants|||Count of Participants
832577|NCT01256567|Secondary|Clearance (Cl) of Ramucirumab|Clearance (Cycle 1) and at steady state (Clss, Cycle 4) of ramucirumab are provided.|Day 1 of Cycle 1 and Cycle 4 (cycle=21 days)|All participants with evaluable clearance data at the specified time points.||milliliters per hour (mL/hr)||Geometric Coefficient of Variation|Geometric Mean
831987|NCT01251588|Secondary|Change From MACI00206 Baseline for the Participant's KOOS Pain and Function (Sports and Recreational Activities) Scores|The KOOS is a validated knee-specific instrument developed to assess the patients' opinion of their knee and associated problems. KOOS consists of 5 subscales: Pain, Function in sports and recreational activities, other Symptoms, Function in activities of daily living (ADL), and knee related Quality of life (QOL). A 5-point Likert scale was used to record the response to each item ranging from 0 (no problems) to 4 (extreme problems). Within each subscale, items were added up and normalized to a value between 0 (extreme problems) and 100 (no problems). Subscales are not combined to calculate a total score.|MACI00206 Baseline and Week 260|Analysis population includes all participants who completed each KOOS subscale at Week 260.||units on a scale||Full Range|Mean
831988|NCT01251588|Primary|Change From MACI00206 Baseline for the Participant's Knee Injury and Osteoarthritis Outcome (KOOS) Pain and Function (Sports and Recreational Activities) Scores.|The KOOS is a validated knee-specific instrument developed to assess the patients' opinion of their knee and associated problems. KOOS consists of 5 subscales: Pain, Function in sports and recreational activities, other Symptoms, Function in activities of daily living (ADL), and knee related Quality of life (QOL). A 5-point Likert scale was used to record the response to each item ranging from 0 (no problems) to 4 (extreme problems). Within each subscale, items were added up and normalized to a value between 0 (extreme problems) and 100 (no problems). Subscales are not combined to calculate a total score.|MACI00206 Baseline to Week 156|The analysis population (n=128) consists of a subpopulation of participants enrolled in the SUMMIT study (n=144). 65 of 65 MACI treated patients and 57 of 63 microfracture-treated patients completed the KOOS at Week 156.||units on a scale||Full Range|Mean
831989|NCT01251614|Secondary|Change From Baseline in the Children's Depression Inventory: Short (CDI:S)|The CDI:S is a short 10-item self-rated symptom-oriented scale used to screen for depressive symptoms. CDI:S scores range from 0 to 100, with a lower score indicating fewer depressive symptoms.|Baseline, Period A, Weeks 4, 8, and 16|LOCF imputation was used, the analysis was conducted in the intent-to-treat (ITT) population with available data at baseline.||units on a scale||Standard Deviation|Mean
831990|NCT01251614|Secondary|Change From Baseline in PedsQL Over Time|The PedsQL Measurement Model measures health-related quality of life (HRQOL) in children and adolescents. The 23-item PedsQL Generic Core Scale includes Physical, Emotional, Social, School Functioning dimensions. Each item is scored from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale, so that higher scores indicate better HRQOL; the total score therefore ranges from 0 (worst) to 100 (best).|Baseline, Period A, Weeks 4 and 8, Period C, Weeks 0 and 4, Period D, Weeks 0, 11, 28, and 52|LOCF imputation was used, the analysis was conducted in the intent-to-treat (ITT) population with available data at baseline.||units on a scale||Standard Deviation|Mean
831991|NCT01251614|Secondary|Time to PASI 50/75/90/100 Response in Period A|Participants who did not have a response during Period A were censored.|Period A, 16 weeks|Analysis was conducted in the intent to-treat (ITT) population.||days||Inter-Quartile Range|Median
831992|NCT01251614|Secondary|Percentage of Participants With CDLQI = 0 Over Time|The Children's Dermatology Life Quality Index (CDLQI) is a 10-item questionnaire to measure the quality of life in children aged from 4 to 16 years. Each question is scored from 0 (not at all) to 3 (very much). The CDLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired and a score of 0 indicates no impairment in quality of life.|Period A, Weeks 4, 8 and 16, Period C, Weeks 0 and 4, Period D, Weeks 0, 11, 28, and 52|Non-responder imputation was used, the analysis was conducted in the intent to-treat (ITT) population.||percentage of participants|||Number
831993|NCT01251614|Secondary|Change From Baseline in CDLQI Over Time|The Children's Dermatology Life Quality Index (CDLQI) is a 10-item questionnaire to measure the quality of life in children aged from 4 to 16 years. Each question is scored from 0 (not at all) to 3 (very much). The CDLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.|Baseline, Period A, Weeks 4, and 8, Period C, Weeks 0 and 4, Period D, Weeks 0, 11, 28, and 52|LOCF imputation was used, the analysis was conducted in the intent-to-treat (ITT) population with available data at baseline.||units on a scale||Standard Deviation|Mean
831994|NCT01251614|Secondary|Percent Change From Baseline in PASI Score Over Time|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis).|Baseline, Period A, Weeks 4, 8, 11 and 16, Period C, Weeks 0 and 16, Period D, Weeks 0, 16, 28, 40 and 52|LOCF imputation was used, the analysis was conducted in the intent-to-treat (ITT) population.||percent change||Standard Deviation|Mean
831995|NCT01251614|Secondary|Percentage of Participants Who Achieved a PASI 100 Response Over Time|"PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis).
A PASI 100 response is a 100% reduction (improvement) from Baseline in PASI score."|Baseline, Period A, Weeks 4, 8, and 11, Period C, Weeks 0 and 16, Period D, Weeks 0, 16, 28, 40 and 52|Non-responder imputation was used, the analysis was conducted in the ITT population.||percentage of participants|||Number
831996|NCT01251614|Secondary|Percentage of Participants Who Achieved a PASI 90 Response Over Time|"PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis).
A PASI 90 response is at least a 90% reduction (improvement) from Baseline in PASI score."|Baseline, Period A, Weeks 4, 8 and 11, Period C, Weeks 0 and 16, Period D, Weeks 0, 16, 28, 40 and 52|Non-responder imputation was used, the analysis was conducted in the ITT population.||percentage of participants|||Number
832018|NCT01251653|Secondary|Area Under the Concentration-time Curve (AUC) Tau,ss of Afatinib|Area under the concentration-time curve of Afatinib in plasma over a uniform dosing interval t at steady state.|PK samples were taken at hours; 167:55, 479:55, 481:05, 482:05, 483:05, 485:05, 487:05 and on day 22 at hours; -0:10, 1, 2, 3, 5, 7, 23:55|The Pharmacokinetic Set (PKS) was a subset of the Treated Set that included all patients who had taken at least 1 dose of study medication and for whom at least 1 valid plasma concentration was available.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
831998|NCT01251614|Secondary|Percentage of Participants Who Achieved a PASI 50 Response Over Time|"PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis).
A PASI 50 response is at least a 50% reduction (improvement) from Baseline in PASI score."|Baseline, Period A, Weeks 4, 8, 11 and 16, Period C, Weeks 0 and 16, Period D, Weeks 0, 16, 28, 40 and 52|Non-responder imputation was used, the analysis was conducted in the ITT population.||percentage of participants|||Number
831999|NCT01251614|Secondary|"Percentage of Participants Achieving a PGA of Cleared (0) Over Time"|"The PGA is a 6-point scale used to measure the severity of disease at the time of the evaluation. The degree of overall lesion severity was evaluated using the following categories: 0 (Cleared): No evidence of scaling, erythema, or plaque elevation; 1 (Minimal): Occasional fine scale over <5% of lesions, faint erythema, minimal plaque elevation; 2 (Mild): Fine scale dominates, light red coloration, mild plaque elevation; 3 (Moderate): Course scale dominates, moderate red coloration, moderate plaque elevation; 4 (Marked): Thick non-tenacious scale dominates, bright red coloration, marked plaque elevation; 5 (Severe): Very thick tenacious scale predominates, dusky to deep red coloration, severe plaque elevation.
The percentage of participants achieving a score of clear (0) is reported."|Period A, Weeks 4, 8, 11 and 16, Period C, Weeks 0 and 16, Period D, Weeks 0, 16, 28, 40 and 52|Non-responder imputation was used, the analysis was conducted in the ITT population.||percentage of participants|||Number
832000|NCT01251614|Secondary|"Percentage of Participants Achieving a PGA of Cleared (0) or Minimal (1) Over Time"|The PGA is a 6-point scale used to measure the severity of disease at the time of the evaluation. The degree of overall lesion severity was evaluated using the following categories: 0 (Cleared): No evidence of scaling, erythema, or plaque elevation; 1 (Minimal): Occasional fine scale over <5% of lesions, faint erythema, minimal plaque elevation; 2 (Mild): Fine scale dominates, light red coloration, mild plaque elevation; 3 (Moderate): Course scale dominates, moderate red coloration, moderate plaque elevation; 4 (Marked): Thick non-tenacious scale dominates, bright red coloration, marked plaque elevation; 5 (Severe): Very thick tenacious scale predominates, dusky to deep red coloration, severe plaque elevation. The percentage of participants achieving a score of clear (0) or minimal (1) is reported.|Period A, Weeks 4, 8 and 11, Period C, Weeks 0 and 16, Period D, Weeks 0, 16, 28, 40 and 52|Non-responder imputation was used, the analysis was conducted in the ITT population.||percentage of participants|||Number
832001|NCT01251614|Secondary|Time to Loss of Disease Control for Participants Who Entered Period B|"Loss of disease control was defined as a worsening of PGA scores in comparison to Week 16 of Period A by at least 2 grades after treatment withdrawal. The PGA is a 6-point scale used to measure the severity of disease at the time of the evaluation. Scores range from 0 (no evidence of scaling, erythema, or plaque elevation) to 5 (very thick tenacious scale predominates, dusky to deep red coloration, severe plaque elevation).
Participants who did not lose disease control in period B continued off drug into period D and were observed off-drug until they finally lost disease control or until the end of the 52 weeks of period D."|Period B (36 weeks) and Period D (52 weeks)|This analysis was conducted in the ITT population who entered period B, no imputation was used.||days||Inter-Quartile Range|Median
832002|NCT01251614|Secondary|"Percentage of Participants Achieving a PGA of Cleared (0) or Minimal (1) Upon Re-Treatment in Period C"|The PGA is a 6-point scale used to measure the severity of disease at the time of the evaluation. The degree of overall lesion severity was evaluated using the following categories: 0 (Cleared): No evidence of scaling, erythema, or plaque elevation; 1 (Minimal): Occasional fine scale over < 5% of lesions, faint erythema, minimal plaque elevation; 2 (Mild): Fine scale dominates, light red coloration, mild plaque elevation; 3 (Moderate): Course scale dominates, moderate red coloration, moderate plaque elevation; 4 (Marked): Thick non-tenacious scale dominates, bright red coloration, marked plaque elevation; 5 (Severe): Very thick tenacious scale predominates, dusky to deep red coloration, severe plaque elevation. The percentage of participants achieving a score of clear (0) or minimal (1) is reported.|Period C, Week 16|Non-responder imputation was used, the analysis was conducted in the ITT population who entered Period C.||percentage of participants|||Number
832003|NCT01251614|Secondary|Change From Baseline in the Pediatric Quality of Life Inventory (PedsQL) Score at Week 16|The PedsQL Measurement Model measures health-related quality of life (HRQOL) in children and adolescents. The 23-item PedsQL Generic Core Scale includes Physical, Emotional, Social, School Functioning dimensions. Each item is scored from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale, so that higher scores indicate better HRQOL; the total score therefore ranges from 0 (worst) to 100 (best).|Baseline and Week 16|LOCF imputation was used, the analysis was conducted in the intent-to-treat (ITT) population; only participants with Baseline and at least one post-baseline value are included.||units on a scale||Standard Deviation|Mean
832004|NCT01251614|Secondary|Change From Baseline in the Children's Dermatology Life Quality Index (CDLQI) Score at Week 16|The Children's Dermatology Life Quality Index (CDLQI) is a 10-item questionnaire to measure the quality of life in children aged from 4 to 16 years. Each question is scored from 0 (not at all) to 3 (very much). The CDLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.|Baseline and Week 16|Last observation carried forward (LOCF) imputation was used, the analysis was conducted in the intent-to-treat (ITT) population; only participants with Baseline and at least one post-baseline value are included.||units on a scale||Standard Deviation|Mean
832005|NCT01251614|Secondary|Percentage of Participants Who Achieved a PASI 100 Response at Week 16|"PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis).
A PASI 100 response is a 100% reduction (improvement) from Baseline in PASI score at Week 16."|Baseline and Week 16|Non-responder imputation was used, the analysis was conducted in the intent-to-treat (ITT) population.||percentage of participants|||Number
832019|NCT01251653|Secondary|Overall Survival (OS)|Overall survival was defined as the time from the first administration of study medication to the time of death from any cause.|From the first administration of study medication to the time of death|TS, MTD cohort||Weeks||Inter-Quartile Range|Median
832578|NCT01256567|Secondary|Half Life (t 1/2) of Ramucirumab||Day 1 of Cycles 1 and 4 (cycle=21 days)|All participants with evaluable t1/2 data at the specified time points.||days||Geometric Coefficient of Variation|Geometric Mean
832006|NCT01251614|Secondary|Percentage of Participants Who Achieved a PASI 90 Response at Week 16|"PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis).
A PASI 90 response is at least a 90% reduction (improvement) from Baseline in PASI score at Week 16."|Baseline and Week 16|Non-responder imputation was used, the analysis was conducted in the intent-to-treat (ITT) population.||percentage of participants|||Number
832007|NCT01251614|Primary|"Percentage of Participants Achieving a Physician’s Global Assessment of Disease Activity (PGA) of Cleared (0) or Minimal (1) at Week 16"|"The PGA is a 6-point scale used to measure the severity of disease at the time of the evaluation. The degree of overall lesion severity was evaluated using the following categories:
0 (Cleared): No evidence of scaling, erythema, or plaque elevation;
1 (Minimal): Occasional fine scale over <5% of lesions, faint erythema, minimal plaque elevation;
2 (Mild): Fine scale dominates, light red coloration, mild plaque elevation;
3 (Moderate): Course scale dominates, moderate red coloration, moderate plaque elevation;
4 (Marked): Thick non-tenacious scale dominates, bright red coloration, marked plaque elevation;
5 (Severe): Very thick tenacious scale predominates, dusky to deep red coloration, severe plaque elevation.
The percentage of participants achieving a score of clear (0) or minimal (1) is reported."|Week 16|Non-responder imputation was used, the analysis was conducted in the ITT population.||percentage of participants|||Number
832008|NCT01251614|Primary|Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI) 75 Response at Week 16|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A PASI 75 response is defined as at least a 75% reduction (improvement) from Baseline in PASI score at Week 16.|Baseline and Week 16|Non-responder imputation was used, the analysis was conducted in the intent-to-treat (ITT) population.||percentage of participants|||Number
832009|NCT01251653|Secondary|Volume of Distribution at Steady State (Vss) of Docetaxel|Apparent volume of distribution at steady state (Vss) of Docetaxel.|PK samples were taken on day 1 at hours; -0:05, 1, 2, 3, 5, 7, 23:55 and on day 22 at hours; -0:10, 1, 2, 3, 5, 7, 23:55|The Pharmacokinetic Set (PKS) was a subset of the Treated Set that included all patients who had taken at least 1 dose of study medication and for whom at least 1 valid plasma concentration was available.||L||Geometric Coefficient of Variation|Geometric Mean
832010|NCT01251653|Secondary|Total Clearance (CL) of Docetaxel|Total Clearance (CL) of Docetaxel from plasma.|PK samples were taken on day 1 at hours; -0:05, 1, 2, 3, 5, 7, 23:55 and on day 22 at hours; -0:10, 1, 2, 3, 5, 7, 23:55|The Pharmacokinetic Set (PKS) was a subset of the Treated Set that included all patients who had taken at least 1 dose of study medication and for whom at least 1 valid plasma concentration was available.||mL/min||Geometric Coefficient of Variation|Geometric Mean
832011|NCT01251653|Secondary|Cmax of Docetaxel|Maximum concentration of docetaxel in plasma.|PK samples were taken on day 1 at hours; -0:05, 1, 2, 3, 5, 7, 23:55 and on day 22 at hours; -0:10, 1, 2, 3, 5, 7, 23:55|The Pharmacokinetic Set (PKS) was a subset of the Treated Set that included all patients who had taken at least 1 dose of study medication and for whom at least 1 valid plasma concentration was available.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
832012|NCT01251653|Secondary|AUC 0-24 of Docetaxel|Area under the concentration-time curve of docetaxel in plasma over the time interval from 0 up to 24 hours|PK samples were taken on day 1 at hours; -0:05, 1, 2, 3, 5, 7, 23:55 and on day 22 at hours; -0:10, 1, 2, 3, 5, 7, 23:55|The Pharmacokinetic Set (PKS) was a subset of the Treated Set that included all patients who had taken at least 1 dose of study medication and for whom at least 1 valid plasma concentration was available.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
832013|NCT01251653|Secondary|Volume of Distribution at Steady State (Vss) of Gemcitabine|Apparent volume of distribution at steady state (Vss) of Gemcitabine.|PK samples were taken on day 1 at hours; -0:05, 0:30, 1, 1:30, 2, 3 and on day 22 at hours; -0:10, 0:30, 1, 1:30, 2, 3|The Pharmacokinetic Set (PKS) was a subset of the Treated Set that included all patients who had taken at least 1 dose of study medication and for whom at least 1 valid plasma concentration was available.||L||Geometric Coefficient of Variation|Geometric Mean
832014|NCT01251653|Secondary|Total Clearance (CL) of Gemcitabine|Total Clearance (CL) of Gemcitabine from plasma.|PK samples were taken on day 1 at hours; -0:05, 0:30, 1, 1:30, 2, 3 and on day 22 at hours; -0:10, 0:30, 1, 1:30, 2, 3|The Pharmacokinetic Set (PKS) was a subset of the Treated Set that included all patients who had taken at least 1 dose of study medication and for whom at least 1 valid plasma concentration was available.||mL/min||Geometric Coefficient of Variation|Geometric Mean
832015|NCT01251653|Secondary|Cmax of Gemcitabine|Maximum concentration of Gemcitabine in plasma.|PK samples were taken on day 1 at hours; -0:05, 0:30, 1, 1:30, 2, 3 and on day 22 at hours; -0:10, 0:30, 1, 1:30, 2, 3|The Pharmacokinetic Set (PKS) was a subset of the Treated Set that included all patients who had taken at least 1 dose of study medication and for whom at least 1 valid plasma concentration was available.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
832016|NCT01251653|Secondary|AUC 0-tz of Gemcitabine|Area under the concentration-time curve of Gemcitabine in plasma over the time interval from 0 up to the last quantifiable data point|PK samples were taken on day 1 at hours; -0:05, 0:30, 1, 1:30, 2, 3 and on day 22 at hours; -0:10, 0:30, 1, 1:30, 2, 3|The Pharmacokinetic Set (PKS) was a subset of the Treated Set that included all patients who had taken at least 1 dose of study medication and for whom at least 1 valid plasma concentration was available.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
832017|NCT01251653|Secondary|Cmax,ss of Afatinib|Maximum concentration of Afatinib in plasma at steady state.|PK samples were taken at hours; 167:55, 479:55, 481:05, 482:05, 483:05, 485:05, 487:05 and on day 22 at hours; -0:10, 1, 2, 3, 5, 7, 23:55|The Pharmacokinetic Set (PKS) was a subset of the Treated Set that included all patients who had taken at least 1 dose of study medication and for whom at least 1 valid plasma concentration was available.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
832020|NCT01251653|Secondary|Progression Free Survival (PFS)|Progression-free survival was defined as the time from the first administration of study medication to the time of disease progression or death, whichever occurred first.|From the first administration of study medication to the time of disease progression or death|TS, MTD cohort||Weeks||Inter-Quartile Range|Median
832023|NCT01251653|Secondary|Time to Objective Response According to RECIST v1.1|Objective response according to RECIST v1.1. Objective response is complete response or partial response for patients with measurable disease. Time to objective response is the time from the start of treatment to the date of first documented complete response or partial response. Descriptive analyses has been performed for the time to objective response (N(%) of patients with first occurrence of objective response at 6, 12 and 24 weeks). Onset of objective response is derived for patient with measurable disease.|6 weeks, 12 weeks and 24 weeks|TS||Participants|||Number
832024|NCT01251653|Secondary|Objective Response According to RECIST v1.1|Objective response according to RECIST v1.1. Objective response is complete response or partial response for patients with measurable disease. Missing categories signify that no tumour imaging has been performed post baseline, and therefore the response status could not be assessed.|From first drug administration until 28 days after last drug administration, up to 717 days.|TS||Participants|||Number
832025|NCT01251653|Secondary|Disease Control According to RECIST v1.1|Disease control according to RECIST v1.1 Disease control is complete response, partial response or stable disease for measurable patients and complete response or non−CR/non−PD for non−measurable patients. Missing categories signify that no tumour imaging has been performed post baseline, and therefore the response status could not be assessed.|From first drug administration until 28 days after last drug administration, up to 717 days.|TS||Participants|||Number
832026|NCT01251653|Secondary|Best Overall Response According to RECIST v1.1 Criteria|Best overall response (according to Response Evaluation Criteria in Solid Tumours [RECIST] version 1.1) was the best response recorded at any time from the date of the first administration of afatinib or gemcitabine/docetaxel to the end of treatment (EOT). Partial response is for patients with measurable disease. Missing categories signifies that no tumour imaging has been performed post baseline, and therefore the response status could not be assessed.|From first drug administration until 28 days after last drug administration, up to 717 days.|TS||Participants|||Number
832027|NCT01251653|Secondary|The Incidence and Intensity of AEs With Grading According to CTCAE.|The incidence and intensity of adverse events with grading according to CTCAE. The CTCAE grades are: 1 (mild AE), 2 (moderate AE), 3 (severe AE), 4 (life-threatening or disabling AE), 5 (death related to AE).|From first drug administration until 28 days after last drug administration, up to 717 days.|TS||Participants|||Number
832028|NCT01251653|Primary|Number of Participants With Dose Limiting Toxicities (DLTs) in Process for the Determination of the Maximum Tolerated Dose (MTD).|DLT was based on following criterions: 1. Grade 4 uncomplicated (not associated with fever >38.5° C (Celsius)) neutropenia for ≥7 days. 2. Grade 3 or 4 neutropenia concomitant with fever >38.5º C or Grade ≥3 infection. 3. Platelet count of <25x 10^9/L or <50x 10^9/L with bleeding requiring whole blood transfusion. 4. Grade ≥3 non-haematological toxicity (except untreated nausea, untreated vomiting, or untreated diarrhoea). 5. Grade ≥2 decrease in cardiac left ventricular function. 6. Grade ≥2 worsening of renal function as measured by serum creatinine, newly developed proteinuria, or a newly developed decrease in glomerular filtration rate. Toxicity grading was based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0|3 weeks|Treated Set (TS)||Participants|||Number
832029|NCT01251757|Secondary|Percentage With Good (<=100mg/dL) Low Density Lipoprotein (LDL) Control|Using the last LDL measurement (fasting or nonfasting) available in the EMR post randomization, we defined good control as an LDL level <= 100 mg/dL.|12 months post randomization|All randomized participants who were taking a statin at the time of randomization and who had at least one post randomization LDL measurement recorded in the EMR. Missing data were not imputed.||percentage with controlled LDL|||Number
832030|NCT01251757|Secondary|Post Intervention Low Density Lipoprotein (LDL) Level|We used the latest LDL (fasting or nonfasting) available during 12 months post randomization. no missing data were imputed.|12 months post randomization|All randomized participants who were taking statin at the time of randomization and who had at least one post randomization LDL measurement recorded in the EMR. Missing data were not imputed.||mg/dL||Standard Deviation|Mean
832031|NCT01251757|Secondary|Percentage With Good (<140/90 mmHg) Blood Pressure Control|Using the mean of last 5 available blood pressure measurements post randomization, we defined BP control as a means systolic BP <140 mmHg and a mean diastolic BP < 90 mmHg.|12 months post randomization|All randomized participants who were taking an ACEI or an ARB at the time of randomization and who had at least one post randomization BP recorded in the EMR. Missing data were not imputed.||percentage of subjects with good control|||Number
832032|NCT01251757|Secondary|Systolic Blood Pressure (SBP)|Mean of last 5 SBP measurements captured in the electronic medical record for the 12 months post randomization.|12-months post randomization|The analysis sample was restricted to ACEI/ARB users with at least one post intervention SBP measurement recorded in the EMR. We did not impute any missing data.||mm Hg||Standard Deviation|Mean
832033|NCT01251757|Secondary|Percentage With Good (>80%) ACEI/ARB Adherence|Binary indicator of good ACEI/ARB adherence, defined as an mMPR>0.80. 1=yes, 0=no.|12 months post randomization|All randomized participants who were taking an ACEI or an ARB at the time of randomization||Percent with good adherence|||Number
832034|NCT01251757|Secondary|Percentage With Good (>80%) Statin Adherence|Binary indicator of good statin adherence, defined as an mMPR>0.80. 1=yes, 0=no.|12 months post randomization|All randomized participants who were taking statins at the time of randomization.||percent with good adherence|||Number
832035|NCT01251757|Primary|Adherence to Angiotensin-Converting Enzyme Inhibitors (ACEIs) and Angiotensin Receptor Blockers (ARBs)|We used medication dispensing data from the Kaiser outpatient pharmacies to calculate a modified medication possession ratio (mMPR) for the subset of randomized participants who were using ACEIs or ARBs. Nominally mMPR provides an estimate of the proportion of days during the follow-up period during which the participant was adherent to their prescribed medications.|12 months post randomization|All randomized participants who were taking an ACEI or an ARB at the time of randomization||mMPR expressed as a fraction||Standard Deviation|Mean
832070|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Activated Partial Thromboplastin Time (APTT) Based Activated Protein-C Resistance (APC)|"The APC resistance assay is a clotting test that measures the ratio of APTT clotting times in the presence and absence of a standard amount of exogenous APC. APC resistance is calculated as the ratio of the clotting time after APC addition over the clotting time with no APC addition.
APC resistance is defined as a poor anticoagulant response of plasma to APC (minimal prolongation of the APTT) and a correspondingly low ratio."|Baseline to Month 6|Per-protocol population with available data||ratio||Standard Error|Least Squares Mean
832036|NCT01251757|Primary|Adherence to Statins|"We used a modification of the Medication Possession Ratio (MPR) as our primary outcome measure. The MPR is computed as the number of days’ supply of medication dispensed during a given time window divided by the time between the first dispensing in the window and the end of the window. Our modified MPR (mMPR) also accounted for medication that was on hand at the start of the window and ignored any days’ supply that would extend beyond the end of the window.
We used medication dispensing data from the Kaiser outpatient pharmacies to calculate a modified medication possession ratio (mMPR) for statins among the subset of randomized participants who were using these drugs. Nominally mMPR provides an estimate of the proportion of days during the follow-up period during which the participant was adherent to their prescribed medications."|12 months post randomization|All randomized participants who were taking statins at the time of randomization||mMPR as a fraction||Standard Deviation|Mean
832037|NCT01251770|Secondary|IV Fluid Intake||12 hours from baseline|||ml||Standard Deviation|Mean
832038|NCT01251770|Primary|Change in Sodium Levels||Change from baseline in sodium level after 12 hours|||mEq/L||Standard Deviation|Mean
832039|NCT01251952|Secondary|To Evaluate the Effect of Ontak on Engraftment of Neutrophils and Platelets Post Transplant at Each Dose.|During hospitalization stay (approximately 2 weeks), participants will receive injections of G-CSF on a daily basis starting on Day 6 and ending when white blood cells have engrafted. Participants usually remain hospitalized until engraftment.|days 0 and 21 post autologous stem cell transplantation||||||
832040|NCT01251952|Secondary|To Evaluate the Effect of Ontak on T Cell CD4/CD8 Reconstitution Post Transplant at Each Dose.||days 0 and 21 post autologous stem cell transplantation||||||
832041|NCT01251952|Secondary|To Evaluate the Effect of Ontak on the Number and Percentage of Regulatory T Cells in the Peripheral Blood Post Transplant at Each Dose Level.||days 0 and 21 post autologous stem cell transplantation||||||
832042|NCT01251952|Primary|Assess Toxicities of Giving Two Doses of Ontak at Days 0 and 21 Post Autologous Stem Cell Transplantation in a Dose Escalation Fashion.|After drug infusion, participants will be closely monitored for at least 4 hours for side effects|Up to 21 days post transplant||||||
832043|NCT01251978|Secondary|Visual Acuity (LogMar)||12 months|||LogMar|||Number
832044|NCT01251978|Secondary|Tumor Thickness||baseline and 1 year|||millimeters (mm)||Full Range|Mean
832045|NCT01251978|Primary|To Evaluate the Safety/Efficacy of Intravitreal Injection of High Dose Ranibizumab Combined With TTT + ICG-based Photodynamic Therapy in the Treatment of Choroidal Melanoma by Reporting the Number of Participants With Complications.||1 year|complications were only assessed in the high dose group||participant|||Number
832047|NCT01252134|Secondary|Corneal Staining Extent|Area (extent) of corneal staining was estimated for each of the five regions of the cornea as a percentage i.e., 0%=no staining in the region and 100%=staining covering the entire region). A staining area percentage was calculated for each eye based on the average staining area measured across all five regions, and the eyes were averaged.|8 hours|This reporting group includes all participants who completed the study.||percentage of cornea||Standard Deviation|Mean
832048|NCT01252134|Secondary|Corneal Staining Type|Five regions of the cornea (central, inferior, temporal, superior, and nasal) were evaluated for staining using cobalt light and a #12 Wratten filter. The type of staining was recorded on a scale of 0 to 100 for each corneal region with 0-none, 25=micropunctate, 50=macropunctate, 75=coalescent, and 100=patch. The five regions for each eye were averaged, and the eyes were averaged.|8 hours|This reporting group includes all participants who completed the study.||Units on a scale||Standard Deviation|Mean
832049|NCT01252134|Secondary|Subjective Comfort|Subjective comfort was assessed by the participant on a scale of 0 to 100, with 0 being very poor comfort and 100 being excellent comfort. The ratings for the right eye and left eye were averaged.|8 hours|This reporting group includes all participants who completed the study.||Units on a scale||Standard Deviation|Mean
832050|NCT01252134|Primary|Ex Vivo Contact Angle|Study lens was removed from the eye according to protocol-specified procedures. The OCA15 Dynamic Contact Angle Instrument was used to observe, record, and calculate contact angle measurements. The measurements from the right eye and left eye were averaged. A lower contact angle measurement indicates a more wettable lens.|8 hours|This reporting group includes all participants who completed the study, minus one response in Synergi group due to a measurement error.||degrees||Standard Deviation|Mean
832051|NCT01252147|Primary|Overall Intra-Rater Reliability of Assessing Overall Eyelash Prominence Using the Japanese Global Eyelash Assessment Scale (GEA-J) at Day 1|Intra-rater (within raters) agreement of the GEA-J scores (1=minimum, 2=moderate, 3=marked, 4=very marked) to assess eyelash prominence was evaluated by weighted Kappa statistics. Weighted Kappa statistics were calculated for each of 7 rater who evaluated 68 subjects using GEA-J scale with photonumeric guide, assessing agreement between 2 different time points at day 1. The overall intra-rater agreement for Kappa statistics for all raters combined was estimated by pooling Kappa statistics for each rater using a chi-square statistic. The degree of agreement of the point estimates of Kappa statistics was interpreted according to the reference range scale that was pre-defined as: <=0: poor, 0.00-0.20: slightly, 0.21-0.40: fair, 0.41-0.60: moderate, 0.61-0.80: substantial, 0.81-1:00: almost perfect. The 95% confidence interval for Kappa statistics is provided.|Day 1|Enrolled population, defined as all patients who were enrolled in (started) the study.||Kappa statistics||95% Confidence Interval|Number
832069|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Endogenous Thrombin Potential (EPT) Based Activated Protein-C Resistance (APC)|"This assay is based on measurement of the effect of activated protein C on the endogenous thrombin potential, the time integral of thrombin generation initiated in plasma through the extrinsic coagulation pathway.
The APC resistance assay measures the ratio of endogenous thrombin potential in the presence and absence of a standard amount of exogenous APC.
APC resistance is calculated as the ratio of EPT after APC addition over the EPT with no APC addition.
APC resistance is defined as a poor anticoagulant response of plasma to APC (less inhibition of thrombin formation) and a correspondingly higher ratio."|Baseline to Month 6|Per-protocol population||ratio||Standard Error|Least Squares Mean
832052|NCT01252147|Primary|Overall Inter-Rater Reliability of Assessing Overall Eyelash Prominence Using the Japanese Global Eyelash Assessment Scale (GEA-J) at Day 1|Inter-rater agreement (among raters) of the GEA-J scores (1=minimum,2=moderate, 3=marked, 4=very marked) to assess eyelash prominence was evaluated using Kendall’s coefficient of concordance (Kendall’s W). Each of 7 raters who scored 68 subjects’ eyelashes using GEA-J Scale with photonumeric guide at 2 different time points at day 1. The overall inter-rater agreement for Kendall’s W for all raters combined was estimated based on the average of the scores from those 2 different time points. The degree of agreement of the point estimates of Kendall’s W was interpreted according to the reference range scale that was pre-defined as: <=0: poor, 0.00-0.20: slightly, 0.21-0.40: fair, 0.41-0.60: moderate, 0.61-0.80: substantial, 0.81-1:00: almost perfect. The 95% confidence interval for Kendall’s W is provided.|Day 1|Enrolled population, defined as all patients who were enrolled in (started) the study.||Kendall's W||95% Confidence Interval|Number
832053|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Sex Hormone Binding Globulin (SHBG)||Baseline to Month 6|Per-protocol population with available data||mIU/L||Standard Error|Least Squares Mean
832054|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Corticosteroid Binding Globulin||Baseline to Month 6|Per-protocol population with available data||nmol/L||Standard Error|Least Squares Mean
832055|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Total Cortisol||Baseline to Month 6|Per-protocol population||nmol/L||Standard Error|Least Squares Mean
832056|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Thyroid Stimulating Hormone (TSH)||Baseline top Month 6|Per-protocol population with available data||mIU/L||Standard Error|Least Squares Mean
832057|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Tissue Factor Pathway Inhibitor (TFPI)|Tissue Factor Pathway Inhibitor (TFPI) is an anti-coagulation protein that binds to activated protein X.|Baseline to Month 6|Per-protocol population||ng/mL||Standard Error|Least Squares Mean
832058|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Total Protein S|"Protein S helps to regulate blood clot formation. Protein S exists in two forms: a free form and a complex form. Free protein S combines with activated protein C to degrade coagulation factors VIIIa and Va, slowing down the generation of new thrombin and inhibiting further clotting.
Results are reported as a percent of the amount expected in normal plasma. By definition, the mean value in normal plasma is 100%. The reference range is approximately 70% to 140%; lower for women than for men."|Baseline to Month 6|Per-protocol population||percentage of normal||Standard Error|Least Squares Mean
832059|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Free Protein S|"Protein S helps to regulate blood clot formation. Protein S exists in two forms: a free form and a complex form. Free protein S combines with Protein C to degrade coagulation factors VIIIa and Va, slowing down the generation of new thrombin and inhibiting further clotting.
Results are reported as a percent of the amount expected in normal plasma. By definition, the mean value in normal plasma is 100%. The reference range is approximately 70% to 140%; lower for women than for men."|Baseline to Month 6|Per-protocol population||percentage of normal||Standard Error|Least Squares Mean
832060|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Protein C Antigen|"Protein C helps to regulate blood clot formation. Activated Protein C (APC) combines with Protein S (a cofactor) to degrade coagulation factors VIIIa and Va, slowing down the generation of new thrombin and inhibiting further clotting.
Results are reported as a percent of the amount expected in normal plasma. By definition, the mean value in normal plasma is 100%. The reference range is approximately 70% to 140% in adults."|Baseline to Month 6|Per-protocol population||percentage of normal||Standard Error|Least Squares Mean
832061|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Protein C Activity|"Protein C helps to regulate blood clot formation. Activated Protein C (APC) combines with Protein S (a cofactor) to degrade coagulation factors VIIIa and Va, slowing down the generation of new thrombin and inhibiting further clotting.
Results are reported as a percent of the amount expected in normal plasma. By definition, the mean value in normal plasma is 100%. The reference range is approximately 70% to 140% for adults."|Baseline to Month 6|Per-protocol population||percentage of normal||Standard Error|Least Squares Mean
832062|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Antithrombin|"Antithrombin is a protein in the blood that naturally blocks blood clots from forming.
Results are reported as a percent of the amount expected in normal plasma. By definition, the mean value in normal plasma is 100%. The reference range is approximately 80% to 130%.for adults."|Baseline to Month 6|Per-protocol population||percentage of normal||Standard Error|Least Squares Mean
832063|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Factor VIII|"Clotting factor VIII, also known as anti-hemophilic factor (AHF), functions in blood coagulation by stabilizing fibrin clots.
Results are reported as a percent of the amount expected in normal plasma. By definition, the mean value in normal plasma is 100%. The reference range is approximately 70% to 140%.for adults."|Baseline to Month 6|Per-protocol population||percentage of normal||Standard Error|Least Squares Mean
832064|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Factor VII|"Clotting factor VII, also called proconvertin or autoprothrombin I, functions in blood coagulation.
Results are reported as percent of normal plasma concentrations. By definition, normal plasma contains 100% (1 unit/mL) of each factor. The reference range is approximately 60% to 140% for adults."|Baseline to Month 6|Per-protocol population||percentage of normal||Standard Error|Least Squares Mean
832065|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Factor II|Clotting factor II, also called prothrombin, functions in blood coagulation. Results are reported as percent of normal plasma concentrations. By definition, normal plasma contains 100% (1 unit/mL) of each factor. The reference range is approximately 60% to 140% for adults.|Baseline to Month 6|Per-protocol population||percentage of normal||Standard Error|Least Squares Mean
832066|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Tissue Plasminogen Activator (t-PA)|Tissue plasminogen activator catalyzes the conversion of plasminogen to plasmin, the major enzyme responsible for the breakdown of blood clots.|Baseline to Month 6|Per-protocol population||µg/L||Standard Error|Least Squares Mean
832067|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Plasminogen|Plasminogen is the precursor of plasmin, which lyses fibrin clots.|Baseline to Month 6|Per-protocol population||g/L||Standard Error|Least Squares Mean
832068|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Fibrinogen|Fibrinogen (factor I) is a glycoprotein that helps in the formation of blood clots.|Baseline to Month 6|Per-protocol population||g/L||Standard Error|Least Squares Mean
832073|NCT01252186|Primary|Change From Baseline to End of Month 6 in Prothrombin Fragment 1+2 Levels|Prothrombin fragment 1+2 is a coagulation factor, released when prothrombin is cleaved by activated factor X. Elevated plasma levels of prothrombin fragment 1+2 indicate high risk of thrombosis.|Baseline to Month 6|Per-Protocol (PP) Population included all data from ITT participants obtained prior to experiencing major protocol violations.||pmol/L||Standard Error|Least Squares Mean
832074|NCT01252238|Primary|Diastolic Function||12 weeks||||||
832075|NCT01252238|Primary|Aortic Compliance||12 weeks||||||
832076|NCT01252238|Primary|Change in Insulin Sensitivity by HOMA at 12 Weeks|The difference (change) in HOMA calculated as Baseline HOMA minus 12-week HOMA value|12 weeks|||HOMA Scale||Standard Deviation|Mean
832077|NCT01252251|Secondary|Median Overall Survival (OS)||Up to 3 years|||months||Full Range|Median
832078|NCT01252251|Secondary|Safety and Toxicity in This Patient Population.|Safety assessments will consist of monitoring and recording all adverse events, including serious adverse events, the regular monitoring of hematology (including glycosylated hemoglobin and coagulation parameters), blood chemistry (including fasting glucose, thyroid function tests, GH, IGF-1 and prolactin), urinalysis, regular monitoring of vital signs, echocardiography, ECGs, and body weight. Toxicity will be assessed using the NCI-CTC for Adverse Events, version 4.0 (CTCAEv4.0,|16 weeks|||Participants|||Count of Participants
832079|NCT01252251|Secondary|Median Progression Free Survival(PFS)||Up to 3 years|||weeks||Full Range|Median
832080|NCT01252251|Primary|Number of Participants With Stable Disease (SD)|For patients with metastatic uveal melanoma treated with RAD001 and pasireotide LAR.|at 16 weeks|||Participants|||Count of Participants
832081|NCT01252251|Primary|Number of Participants With Partial Response (PR)|For patients with metastatic uveal melanoma treated with RAD001 and pasireotide LAR.|at 16 weeks|||Participants|||Count of Participants
832082|NCT01252251|Primary|Number of Participants With Complete Response (CR)|For patients with metastatic uveal melanoma treated with RAD001 and pasireotide LAR.|at 16 weeks|||Participants|||Count of Participants
832083|NCT01252277|Secondary|Change in Quality of Life.|Change in score on Breast Cancer Prevention Trial (BCPT) Symptom Checklist. 43 symptoms, each scored as 0 to 4, are summed to provide a global score (range 0 to 172). Increasing score represents increasing problems with side effects. For change in score over period of intervention, a negative score indicates an improvement in quality of life while a positive score indicates increasing interference with daily activities due to worsening symptoms. Theoretically, the range of change could be -172 to +172.|duration of intervention, baseline to ~ 6 months|Subjects completing intervention||units on a scale||Inter-Quartile Range|Median
832084|NCT01252277|Secondary|Change in (DHA+EPA):AA Ratio for Phospholipids in Plasma.|Change (from baseline to end of study) for the ratio derived from levels of DHA, EPA, and Arachadonic Acid (AA); measured as percent of total fatty acid content in the phospholipid compartment of plasma.|baseline to end of intervention (~6 months)|Subjects completing intervention||ratio||Inter-Quartile Range|Median
832085|NCT01252277|Secondary|Modulation of Ki-67 Expression|Change (baseline to end of study) in percent of benign breast epithelial cells exhibiting immunostaining for Ki-67|6 month value compared to baseline value|||Change in percent Ki-67 expression||Inter-Quartile Range|Median
832086|NCT01252277|Secondary|Modulation of the Risk Biomarker Masood Score|Change in the semiquantitative cytology index score (Masood score) from baseline to end of study. Masood Score range 6 - 24; increasing values denote increasing cytologic abnormality. Thus, negative values for change reflect an improvement, i.e., less cytologic abnormality after intervention.|6 month value compared to baseline value|||change in units on a scale||Inter-Quartile Range|Median
832087|NCT01252277|Primary|The Proportion of Subjects That Complete an Intervention of Lovaza™ 4 Grams Per Day|The proportion of subjects that complete an intervention of Lovaza™ 4 grams per day (~ 1800 mg EPA and 1500 mg DHA) administered for 6 months to premenopausal women under age 55.|6 month visit|||proportion of enrolled participants|||Number
832088|NCT01252290|Secondary|Change in Ki-67 Expression|Immunocytochemical staining for Ki-67 antibody. Percent of 500 benign breast epithelial cells scored that are classified as positively staining.|6 month value compared to baseline value|||change in percent Ki-67 expression||Inter-Quartile Range|Median
832089|NCT01252290|Secondary|Change in Quality of Life|Change in score on Breast Cancer Prevention Trial (BCPT) Symptom Checklist. Summation score of degree of difficulty (scored 0 to 4 each) with 43 individual activities. Thus total score ranges from 0 to 172. Increasing score represents increasing problems with side effects.|Change from Baseline to Month 6|||units on a scale||Full Range|Median
832090|NCT01252290|Secondary|Change in (DHA+EPA):AA Ratio for Phospholipids in Plasma|Change (from baseline to end of study) for the ratio derived from levels of DHA, EPA, and AA (measured as percent of total fatty acid content) in the phospholipid compartment of plasma.|Change from Baseline to Month 6|||ratio||Inter-Quartile Range|Median
832091|NCT01252290|Secondary|Modulation of the Risk Biomarker Masood Score|Change in the semiquantitative cytology index score (Masood score) from baseline to end of study. Masood Score range 6 - 24; increasing values denote increasing cytologic abnormality. Thus, negative values for change reflect an improvement, i.e., less cytologic abnormality after intervention.|6 month value compared to baseline value|||units on a scale||Inter-Quartile Range|Median
832092|NCT01252290|Primary|The Proportion of Subjects That Complete Intervention of Lovaza™ 4 Grams Per Day|To determine the feasibility of an intervention of Lovaza™ 4 grams per day (~ 1800 mg EPA and 1500 mg DHA) administered for 6 months to post-menopausal women under the age of 50.|6 month visit|||proportion of enrolled participants|||Number
832093|NCT01252355|Other Pre-specified|Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA)|PCSA values are abnormal values considered medically important by the Sponsor according to predefined criteria based on literature review. Hepatic parameters thresholds were defined as follows: Alanine Aminotransferase (ALT) >3, 5 or 10 Upper Limit of Normal (ULN); Aspartate Aminotransferase (AST) >3, 5 or 10 ULN; Alkaline Phosphatase >1.5 ULN; Total Bilirubin (TB) >1.5 ULN; and ALT >3 ULN and TB >2 ULN.|First study drug intake up to 28 days after last study drug intake, for up to 112 weeks|Safety population as previously defined but including only participants who had post-baseline values.||participants|||Number
832274|NCT01253811|Secondary|Clinical Laboratory Assessments: Haematology: Haematocrit|Clinical laboratory values for haematocrit collected from week 0 to end of trial visit.|Every 6th month, from week 0 to end of trial visit (week 173).|The safety analysis set included all subjects who received at least one dose of the trial product.||percentage of red blood cells||Standard Deviation|Mean
832094|NCT01252355|Secondary|Overview of Adverse Events (AEs)|AEs are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.|First study drug intake up to 28 days after last study drug intake, for up to 112 weeks|Safety population: all randomized and treated participants. Participants were included in the treatment group according to the drug actually received.The participant randomized to Teriflunomide 14 mg group who received Teriflunomide 7 mg was analyzed in the Teriflunomide 7 mg group.||participants|||Number
832095|NCT01252355|Secondary|Resource Utilization When Relapse|Resource utilization each time a participant experiences an MS relapse, specifically the number of hospitalizations, the number of over night spent in the hospital and number of intensive care admissions if hospitalized were to be reported.|Up to a maximum of 108 weeks depending on time of enrollment|Data for this outcome was not analyzed because of insufficient data after early study termination.|||||
832096|NCT01252355|Secondary|Change From Baseline in Short Form Generic Health Survey - 36 Items, Version 2 (SF-36v2) Summary Scores at Week 24|SF-36 scale is a generic, self-administered, health-related quality-of-life (QOL) instrument.|Baseline, Week 24|Data for this outcome was not analyzed because of insufficient data after early study termination.|||||
832097|NCT01252355|Secondary|Change From Baseline in Fatigue Impact Scale (FIS) Total Score at Week 24|FIS is a participant-reported scale that qualifies the impact of fatigue on daily life in participants with MS.|Baseline, Week 24|Data for this outcome was not analyzed because of insufficient data after early study termination.|||||
832098|NCT01252355|Secondary|Time to Relapse: Kaplan-Meier Estimates of the Probability of no Relapse at Week 24, 48, and 72|Probability of no relapse at 24, 48 and 72 weeks was estimated using Kaplan-Meier method on the time to relapse defined as the time from randomization to first EDSS confirmed relapse. Participants free of confirmed relapse (no EDSS confirmed relapse observed on treatment) were censored at the date of the last study drug intake. Kaplan-Meier method consists in computing probabilities of non-occurrence of event at any observed time of event and multiplying successive probabilities for time <=t by any earlier computed probabilities to estimate the probability of being event-free for the amount of time t.|Up to a maximum of 108 weeks depending on time of enrollment|ITT population as previously defined.||percent probability of no relapse||95% Confidence Interval|Number
832099|NCT01252355|Secondary|Brain MRI Assessment: Change From Baseline in Total Lesion Volume (Burden of Disease) at Week 24|The total lesion volume (burden of disease) is the total volumes of hyperintense on T2 plus hypointense on T1 as measured by MRI scan. Least-square means were estimated using a Mixed-effect model with repeated measures (MMRM) on cubic root transformed volume data with factors for treatment, region, IFN-beta dose stratum, visit, treatment-by-visit interaction, cubic root transformed baseline burden of disease, and baseline-by-visit interaction.|Baseline, Week 24|ITT population as previously defined but including only participants who had post-baseline data.||milliliter||Standard Error|Least Squares Mean
832100|NCT01252355|Secondary|Brain MRI Assessment: Volume of Gd-enhancing T1-lesions Per MRI Scan|Total volume of Gd-enhancing T1-lesions per scan is the sum of the volumes of Gd-enhancing T1-lesions observed during the treatment period divided by the total number of scans performed during the treatment period.|Up to a maximum of 108 weeks depending on time of enrollment|ITT population as previously defined but including only participants who had post-baseline data.||milliliters per scan|||Number
832101|NCT01252355|Secondary|Time to 12-Week Sustained Disability Progression|The 12-week sustained disability progression was defined as an increase from baseline of at least 1-point in EDSS score (at least 0.5-point for participants with baseline EDSS score >5.5) that persisted for at least 12 weeks. Probability of disability progression was to be estimated using Kaplan-Meier method.|Up to a maximum of 108 weeks depending on time of enrollment|Data for this outcome was not analyzed because of insufficient data after early study termination.|||||
832102|NCT01252355|Secondary|Brain Magnetic Resonance Imaging (MRI) Assessment: Number of Gadolinium Enhancing (Gd-enhancing) T1-lesions Per Scan (Poisson Regression Estimates)|Number of Gd-enhancing T1-lesions per scan is the total number of Gd-enhancing T1-lesions that occurred during the treatment period divided by the total number of scans performed during the treatment period. To account for the different number of scans among participants, a Poisson regression model with robust error variance was used (total number of Gd-enhancing T1-lesions as response variable; log-transformed number of scans as offset variable; treatment group, region of enrollment, IFN-beta dose stratum and baseline number of Gd-enhancing T1-lesions as covariates).|Up to a maximum of 108 weeks depending on time of enrollment|ITT population as previously defined but including only participants who had post-baseline data.||lesions per scan||95% Confidence Interval|Number
832103|NCT01252355|Primary|Annualized Relapse Rate (ARR) (Poisson Regression Estimates)|"ARR is the total number of confirmed relapses that occurred during the treatment period divided by the total number of patient-years treated. Each episode of relapse (appearance, or worsening of a clinical symptom that was stable for at least 30 days, that persisted for a minimum of 24 hours in the absence of fever) was to be confirmed by an increase in Expanded Disability Status Scale (EDSS) score or Functional System scores. To account for the different treatment durations among participants, a Poisson regression model with robust error variance was used (total number of confirmed relapses as response variable; log-transformed treatment duration as offset variable; treatment group, region of enrollment and IFN-beta dose stratum, and number of relapses in the year prior to randomization as covariates)."|Up to a maximum of 108 weeks depending on time of enrollment|Intent-to-treat (ITT) population: all randomized and treated participants. Participants were considered in the treatment group to which they were randomized regardless of the drug they actually received.||relapses per patient-year||95% Confidence Interval|Number
832104|NCT01252810|Secondary|Assessing the Incidence of Renal Biomarker-based Contrast-induced Acute Kidney Injury (CI-AKI) in Subjects Post Administration of Ioforminol or Iopamidol Injections|Analyzing the number of subjects with renal biomarker-based contrast-induced acute kidney injury (CI-AKI).|2, 6 and 24 hours post Ioforminol and Iopamidol adminstration|Summary of subjects with renal biomarker-based CI-AKI by time point (Per Protocol Population).||Subjects|||Number
832129|NCT01253044|Primary|Brief Symptom Inventory 18 (BSI-18)|To determine if receiving ACT, as compared to PCT, is associated with reduced distress as measured by the BSI-18 General Symptom Index (GSI) at the end of treatment. The BSI-18 GSI summarizes a respondent's overall level of distress. The score used in a normatively based T-score (range 1-100) calculated from the sum of responses. Higher scores are indicative of greater distress.|Baseline and week 12|||T-score||Standard Deviation|Mean
832105|NCT01252810|Secondary|To Determine Incidence Rates of the Overall AEs, Organ-specific AEs (i.e., Delayed Skin Reactions, General Subject Comfort, and Allergic/Immunologic Reactions, Etc.) and SAEs Following Administration|"To determine incidence rates of the overall AEs, organ-specific AEs (i.e., delayed skin reactions, general subject comfort, and allergic/immunologic reactions, etc.) and SAEs following administration of GE-145 or iopamidol.
To determine incidence rates and onset time of biomarker-based and SCr-based CI-AKI following administration of GE-145 or iopamidol.
Summary of Treatment-Emergent Adverse Events (TEAE) in greater than of equal to 2% of Subjects."|Time zero equals the date of contrast imaging and for up to 7 days for safety monitoring post contrast administration.|Summary of Treatment-Emergent Adverse Events (TEAE) in greater than of equal to 2% of Subjects.||Number of events|||Number
832106|NCT01252810|Primary|Comparison of Overall Image Quality Between Ioforminol and Iopamidol-enhanced Images as Determined by an Independent Reader.|Overall image quality (excellent, adequate or poor) and diagnostic usefulness (diagnostic or non-diagnostic) were assessed using qualitative scales.|After the imaging date for either Ioforminol or Iopamidol.|The measured values are looking at 1) Overall Image Quality and, 2) Diagnostic Usefulness.||Number of subjects|||Number
832107|NCT01252940|Secondary|Change From Baseline in Fasting Triglycerides Through Week 48|"The mean (SD) change from baseline in fasting triglycerides through Week 48 was analyzed.
By Week 48, participants FTC/RPV/TDF had received 48 weeks of treatment with FTC/RPV/TDF, while those in the SBR/Delayed Switch group had received only 24 weeks of treatment with FTC/RPV/TDF."|Baseline to Week 48|Participants in the Safety Analysis Set who had measurements for triglycerides at both baseline and Week 48 were analyzed.||mg/dL||Standard Deviation|Mean
832108|NCT01252940|Secondary|Change From Baseline in Fasting Triglycerides Through Week 24|The mean (SD) change from baseline in fasting triglycerides through Week 24 was analyzed.|Baseline to Week 24|Participants in the Safety Analysis Set who had measurements for triglycerides at both baseline and Week 24 were analyzed.||mg/dL||Standard Deviation|Mean
832109|NCT01252940|Secondary|Change From Baseline in Fasting Direct LDL Cholesterol Through Week 48|"The mean (SD) change from baseline in fasting direct LDL cholesterol (mg/dL) through Week 48 was analyzed.
By Week 48, participants FTC/RPV/TDF had received 48 weeks of treatment with FTC/RPV/TDF, while those in the SBR/Delayed Switch group had received only 24 weeks of treatment with FTC/RPV/TDF."|Baseline to Week 48|Participants in the Safety Analysis Set who had measurements for direct LDL cholesterol at both baseline and Week 48 were analyzed.||mg/dL||Standard Deviation|Mean
832110|NCT01252940|Secondary|Change From Baseline in Fasting Direct Low-density Lipoprotein (LDL) Cholesterol Through Week 24|The mean (SD) change from baseline in fasting direct LDL cholesterol (mg/dL) through Week 24 was analyzed.|Baseline to Week 24|Participants in the Safety Analysis Set who had measurements for direct LDL cholesterol at both baseline and Week 24 were analyzed.||mg/dL||Standard Deviation|Mean
832111|NCT01252940|Secondary|Change From Baseline in Fasting HDL Cholesterol Through Week 48|"The mean (SD) change from baseline in fasting HDL cholesterol (mg/dL) through Week 48 was analyzed.
By Week 48, participants FTC/RPV/TDF had received 48 weeks of treatment with FTC/RPV/TDF, while those in the SBR/Delayed Switch group had received only 24 weeks of treatment with FTC/RPV/TDF."|Baseline to Week 48|Participants in the Safety Analysis Set who had measurements for HDL cholesterol at both baseline and Week 48 were analyzed.||mg/dL||Standard Deviation|Mean
832112|NCT01252940|Secondary|Change From Baseline in Fasting High-density Lipoprotein (HDL) Cholesterol Through Week 24|The mean (SD) change from baseline in fasting HDL cholesterol (mg/dL) through Week 24 was analyzed.|Baseline to Week 24|Participants in the Safety Analysis Set who had measurements for HDL cholesterol at both baseline and Week 24 were analyzed.||mg/dL||Standard Deviation|Mean
832113|NCT01252940|Secondary|Change From Baseline in Fasting Total Cholesterol Through Week 48|"The mean (SD) change from baseline in fasting total cholesterol (mg/dL) through Week 48 was analyzed.
By Week 48, participants FTC/RPV/TDF had received 48 weeks of treatment with FTC/RPV/TDF, while those in the SBR/Delayed Switch group had received only 24 weeks of treatment with FTC/RPV/TDF."|Baseline to Week 48|Participants in the Safety Analysis Set who had measurements for total cholesterol at both baseline and Week 48 were analyzed.||mg/dL||Standard Deviation|Mean
832114|NCT01252940|Secondary|Change From Baseline in Fasting Total Cholesterol Through Week 24|The mean (SD) change from baseline in fasting total cholesterol (mg/dL) through Week 24 was analyzed.|Baseline to Week 24|Participants in the Safety Analysis Set who had measurements for total cholesterol at both baseline and Week 24 were analyzed.||mg/dL||Standard Deviation|Mean
832115|NCT01252940|Secondary|Change From Baseline in CD4 Count Through Week 48|"The mean (SD) change in CD4 count was analyzed from baseline through Week 48.
By Week 48, participants FTC/RPV/TDF had received 48 weeks of treatment with FTC/RPV/TDF, while those in the SBR/Delayed Switch group had received only 24 weeks of treatment with FTC/RPV/TDF."|Baseline to Week 48|Participants in the Full Analysis Set who had CD4 measurements at both baseline and Week 48 were analyzed.||cells/mm^3||Standard Deviation|Mean
832116|NCT01252940|Secondary|Change From Baseline in Cluster of Differentiation 4 (CD4) Count Through Week 24|The mean (SD) change in CD4 count was analyzed from baseline through Week 24.|Baseline to Week 24|Participants in the Full Analysis Set who had CD4 measurements at both baseline and Week 24 were analyzed.||cells/mm^3||Standard Deviation|Mean
832117|NCT01252940|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 (FDA Snapshot Analysis)|"The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the FDA snapshot analysis.
By Week 48, participants FTC/RPV/TDF had received 48 weeks of treatment with FTC/RPV/TDF, while those in the SBR/Delayed Switch group had received only 24 weeks of treatment with FTC/RPV/TDF."|Week 48|Participants in the Full Analysis Set in the FTC/RPV/TDF and the Delayed Switch to FTC/RPV/TDF groups were analyzed.||percentage of participants|||Number
832118|NCT01252940|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 (FDA Snapshot Analysis)|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the FDA snapshot analysis.|Week 24|Full Analysis Set: participants who were randomized into the study and received at least one dose of study drug.||percentage of participants|||Number
832130|NCT01253070|Secondary|Event-free Survival|Event-free survival (EFS) was defined as the time for registration to failure to achieve CR during induction, relapse or death. Participants without events were censored at date of last follow-up. The median EFS with 95% CI was estimated using the Kaplan Meier method.|Time from registration to death or relapse (up to 10 years)|||months||95% Confidence Interval|Median
832119|NCT01252966|Secondary|Cognitive Performance (Attention)|Change in performance on the Continuous Performance Task (attention) between Baseline and End of Treatment (Week 12). In this task, participants are presented with a series of letters at 2.5s intervals and are instructed to respond by pressing the space bar if the same letter appears twice in a row. The outcome is the change in the number of commission errors (the number of times the participant responded to a non-target at EOT minus baseline). There are a total of 125 trials, with 20 target trials (response required) and 85 non-target trials (no response required); therefore the possible range for the change score is -85 to 85. Negative numbers indicate a decrease in commission errors (better performance at EOT compared to baseline); positive numbers indicate an increase in commission errors (worse performance at EOT compared to baseline); and 0 indicates no change.|Baseline and Week 12 (EOT)|Participants with performance >3SD from the mean at Baseline were excluded as outliers.||Change in number of commission errors||Standard Deviation|Mean
832120|NCT01252966|Secondary|Cognitive Performance (Response Inhibition)|"Change in performance on the Go/No-Go Task (response inhibition) between Baseline and End of Treatment (Week 12). In this task, participants are presented with a series of stimuli (the word PRESS in either green or red). Participants are instructed to respond by pressing the spacebar when the stimulus is green, and to withhold a response when the stimulus is red. The outcome is the change in number of commission errors (failure to withhold a response to a red stimulus) from EOT minus baseline. The potential range for the change score is -42 to 42. Negative numbers indicate a decrease in the number of commission errors (improved performance) from baseline to EOT; positive numbers indicate an increase in commission errors (worse performance); 0 indicates no change."|Baseline and Week 12 (EOT)|Participants with performance >3SD from the mean at baseline were excluded as outliers.||Change in number of commission errors||Standard Deviation|Mean
832121|NCT01252966|Secondary|Cognitive Performance (Working Memory)|Change in performance on the Digit Span Forward task (working memory) between Baseline and End of Treatment (Week 12). In this task, participants are presented with a series of digits on the computer screen at one second intervals. Participants are then required to enter the digits in order. The number of digits in each series ranges from 3 to 7, and the maximum recall span is the length of the largest series entered correctly. The outcome measure is the change score (calculated by subtracting the Baseline score from the end of treatment score). Change scores can range from -4 to 4. Negative numbers indicate worse performance at EOT; positive numbers indicate better performance at EOT; and 0 indicates no change.|Baseline and Week 12 (EOT)|Participants with performance >3SD from the mean at baseline were excluded as outliers.||Change in maximum recall span||Standard Deviation|Mean
832122|NCT01252966|Secondary|Point-prevalence Abstinence at 6-month Follow-up|Daily smoking from the Target Quit Date to 6 month follow-up was assessed by a validated timeline follow-back measure. Based on guidelines for smoking cessation trials, the secondary outcome was 7-day point prevalence abstinence at the 6 month follow-up, and abstinence was defined as no self-reported smoking (even a puff) for at least 7 days, with in-person verification by carbon monoxide breath levels (CO <8ppm). Following standard convention, participants who withdrew or were lost to follow-up were considered smokers.|6 month follow-up|||Percentage of participants|||Number
832123|NCT01252966|Primary|Point-prevalence Abstinence at End of Treatment|Daily smoking, from the Target Quit Date to End of Treatment (EOT), was assessed by a validated timeline follow-back measure. Based on guidelines for smoking cessation trials, the primary outcome was 7-day point prevalence abstinence at EOT, and abstinence was defined as no self-reported smoking (even a puff) for at least 7 days, with in-person verification by carbon monoxide breath levels (CO <8ppm). Following standard convention, participants who withdrew or were lost to follow-up were considered smokers.|End of treatment (Week 12)|||Percentage of participants|||Number
832124|NCT01253018|Secondary|Stroke Impact Scale: Hand Subscale|The Stroke Impact Scale (SIS) is a self-report structured interview consisting of eight domains designed to assess changes in impairment, disabilities, and handicap following stroke that contribute to quality of life. It has been tested and found to be reliable, valid, and sensitive to change in the stroke population. There are four physical domains that that can be analyzed separately. The hand domain was analyzed for this study and the scores for this domain range from 0-100. Higher scores indicate greater function.|Baseline, 12 week and 24 week retention|All participants completing the 12 week intervention including evaluations at baseline, weeks 12 and the 24 week retention evaluation. The change score from baseline to the final (12 week) evaluation was examined. 1 participant in each group did not return for retention and were not included in the retention analysis.||units on a scale||Standard Deviation|Mean
832125|NCT01253018|Secondary|Wolf Motor Function Test (WMFT)|The Wolf Motor Function Test (WMFT) examines UE function based on task performance time, quality of movement, and ability to hold a weight. Functional use and speed of movement are based on fifteen timed activities and two strength activities. It has high inter-rater reliability, internal consistency, and test-retest reliability. Timed tasks that cannot be completed default to a time score of 120 seconds. Faster times or a lower score in seconds represent better function. Improvement is represented by a decreased time to complete the tasks therefore a negative change score from baseline to follow-up indicates improvement.|Baseline, 12 week, and 24 week retention|All participants completing the 12 week intervention including evaluations at baseline, weeks 4, 8, 12 and at the 24 week retention evaluation. The change score from baseline to the final (12 week) evaluation was examined. 1 participant in each group did not return for retention and were not included in the retention analysis.||seconds||Standard Deviation|Mean
832126|NCT01253018|Secondary|Motor Cortex Excitability Via Transcranial Magnetic Stimulation (TMS)||week 12|The severity of the patients enrolled in the study were such that TMS did not evoke the number of motor action potentials needed for analysis.|||||
832127|NCT01253018|Primary|Fugl-Meyer Motor Upper Extremity Assessment|This is a stroke-specific measure of impairment of the upper extremity that has been shown to be valid and reliable with high inter-rater and test-retest reliability. It provides a direct-observational assessment of volitional movement and motor impairment related to reflexes, sensation, and abnormal synergies. Each item on the FM is rated on a three-point ordinal scale (0 = cannot perform, 1 = performs partially, 2 = performs fully). The scale ranges from 0-66 with higher scores representing less motor impairment.|Baseline, 12 week, and 24 week retention|All participants completing the 12 week intervention including evaluations at baseline, weeks 4, 8, 12 and at the 24 week retention evaluation. 1 participant in each group did not return for retention and were not included in the retention analysis.||units on a scale||Standard Deviation|Mean
832132|NCT01253070|Primary|Overall Survival (OS) Rate|Percentage of patients who were alive at 1 year. The analysis was split between patients with having a FLT3 (FMS-like tyrosine kinase-3) ITD (internal tandem duplication) or TKD (tyrosine kinase domain) mutation. The FLT3 mutation testing at baseline was performed centrally for all patients.|1 year|Three participants withdrew consent to protocol treatment and follow-up prior to 1 year post registration (2 ITD; 1 TKD). These participants have been excluded from the primary endpoint analysis.||percentage of participants||95% Confidence Interval|Number
832133|NCT01253135|Primary|Median Time (in Days) to Wound Closure (Healing) Defined as Skin Re-epithelialization, Without Drainage or Dressing Requirements.|The target wounds were evaluated wound status (open/closed)|All thermal wound injury was done on Day 1. Application of test articles started on Day 2. Target wound assessment was performed on Day 3 and Day 5; subsequent assessments were done Monday through Friday for 2 weeks and subjects exited study on Day 22|ITT Populations: Subjects who participated in version 2 of the protocol. The primary efficacy endpoint was analyzed, using Kaplan-Meier survival analysis, to estimate the median time to wound closure over the 21-day treatment period. Any wound which did not heal by Day 21 was censored in the analysis.||days to closure||95% Confidence Interval|Median
832134|NCT01253135|Primary|Time (in Days) to Wound Closure (Healing) Defined as Skin Re-epithelialization, Without Drainage or Dressing Requirements.|The target wounds were evaluated wound status (open/closed).|All thermal wound injury was done on Day 1. Application of test articles started on Day 2. Target wound assessment was performed on Day 3 and Day 5; subsequent assessments were done Monday through Friday for 2 weeks and subjects exited study on Day 22|ITT Populations: Subjects who participated in version 2 of the protocol. Inter-group comparison was done using a paired Prentice-Wilcoxon method, which is applicable to censored data.||days to wound closure||Standard Deviation|Mean
832135|NCT01253148|Secondary|Overall Response Rate (ORR)|Tumor Response according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. Complete Response (CR): Complete disappearance of all target and non-target lesions; no new lesions. Partial Response (PR): Applies only to patients with at least one measurable lesion; Greater than or equal to 30% decrease under baseline of the sum of appropriate diameters of all target measurable lesions; No unequivocal progression of non-measurable disease; No new lesions.|End of post treatment follow-up period of up to 20 months|All participants||percentage of participants|||Number
832136|NCT01253148|Secondary|Median Overall Survival (OS)|OS is defined as the duration of time from enrollment to time of death from any cause.|Up to 36 months|All participants||months||95% Confidence Interval|Median
832137|NCT01253148|Primary|Median Progression Free Survival (PFS)|PFS is defined as the duration of time from enrollment to time of progression or death from any cause. Progression will be defined as progressive disease in the treated lobe. If progression is seen in a treated lobe, this will be considered a treatment failure. Progressive Disease (PD) according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) Version 1.1.: At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|End of post treatment follow-up period of 20 months|All participants||months||95% Confidence Interval|Median
832138|NCT01253174|Secondary|Time to Reach Maximum Concentration (Tmax) of L-5-methyl-THF|Tmax refers to the time after dosing when a drug attains its highest measurable concentration (Cmax). It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content|up to 12 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.||hour||Full Range|Median
832139|NCT01253174|Secondary|Time to Reach Maximum Concentration (Tmax) of DRSP|Tmax refers to the time after dosing when a drug attains its highest measurable concentration (Cmax). It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content|up to 168 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.||hour||95% Confidence Interval|Median
832140|NCT01253174|Secondary|Mean Area Under the Concentration-time Curve From Administration up to 72h AUC(0-72h) of DRSP|The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample|up to 72 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.||ng∙h/mL||95% Confidence Interval|Geometric Mean
832141|NCT01253174|Secondary|Time to Reach Maximum Concentration (Tmax) of EE|Tmax refers to the time after dosing when a drug attains its highest measurable concentration (Cmax). It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content|up to 96 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.||hour||Full Range|Median
832142|NCT01253174|Primary|Mean Area Under the Concentration-time Curve From Administration to the Last Measurement [AUC(0-tlast)] of L-5-methyl-THF (Baseline Uncorrected) Incl. Bioequivalence (BE) Evaluation|The baseline uncorrected AUC is a measure of the systemic drug exposure provided by the treatment including the endogenous L-5-methyl-THF level. It is obtained by collecting a series of blood samples and measuring the concentrations of L-5-methyl-THF in each sample.|up to 12 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.||nmol∙h/L||95% Confidence Interval|Geometric Mean
832143|NCT01253174|Primary|Mean Maximum Concentration (Cmax) of L-5-methyl-THF (Baseline Uncorrected) Incl. Bioequivalence (BE) Evaluation|The baseline uncorrected Cmax is a measure of the highest measured drug concentration including the endogenous L-5-methyl-THF level. It is obtained by collecting a series of blood samples and measuring the concentrations of L-5-methyl-THF in each sample.|up to 12 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.||nmol/L||95% Confidence Interval|Geometric Mean
832172|NCT01253304|Primary|Pharmacokinetics: Apparent Terminal Elimination Half-life (t1/2)|The half life associated with the terminal rate constant is summarized. This measure was calculated using non-compartmental analysis techniques.|Predose to 336 hours postdose|Participants who received at least one dose of study drug (LY2189265) with evaluable LY2189265 concentration data.||hours||Full Range|Geometric Mean
832144|NCT01253174|Primary|Mean Area Under the Concentration-time Curve From Administration to the Last Measurement [AUC(0-tlast)] of L-5-methyl-THF (Baseline Corrected) Incl. Bioequivalence (BE) Evaluation|The baseline corrected AUC is a measure of the systemic drug exposure provided by the treatment excluding the endogenous L-5-methyl-THF level. It is obtained by collecting a series of blood samples, measuring the concentrations of L-5-methyl-THF in each sample and by subtracting the pre-treatment concentration.|up to 12 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.||nmol∙h/L||95% Confidence Interval|Geometric Mean
832145|NCT01253174|Primary|Mean Maximum Concentration (Cmax) of L-5-methyl-THF (Baseline Corrected) Incl. Bioequivalence (BE) Evaluation|The baseline corrected Cmax is a measure of the highest measured drug concentration provided solely by the treatment after subtracting endogenous L-5-methyl-THF level. It is obtained by collecting a series of blood samples, measuring the concentrations of L-5-methyl-THF in each sample and by subtracting the pre-treatment concentration.|up to 12 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.||nmol/L||95% Confidence Interval|Geometric Mean
832146|NCT01253174|Primary|Mean Area Under the Concentration-time Curve (AUC) of DRSP Incl. Bioequivalence (BE) Evaluation|The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample|up to 168 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.||ng∙h/mL||95% Confidence Interval|Geometric Mean
832147|NCT01253174|Primary|Mean Maximum Concentration (Cmax) of DRSP Incl. Bioequivalence (BE) Evaluation|Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.|up to 168 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.||ng/mL||95% Confidence Interval|Geometric Mean
832148|NCT01253174|Primary|Mean Area Under the Concentration-time Curve From Administration to the Last Measurement [AUC(0-tlast)] of EE Incl. Bioequivalence (BE) Evaluation|The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample|up to 96 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.||pg∙h/mL||95% Confidence Interval|Geometric Mean
832149|NCT01253174|Primary|Mean Maximum Concentration (Cmax) of EE Incl. Bioequivalence (BE) Evaluation|Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.|up to 96 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.||pg/mL||95% Confidence Interval|Geometric Mean
832150|NCT01253187|Secondary|Time to Reach Maximum Concentration (Tmax) of L-5-methyl-THF|Tmax refers to the time after dosing when a drug attains its highest measurable concentration (Cmax). It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content|up to 12 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.||hours||Full Range|Median
832151|NCT01253187|Secondary|Time to Reach Maximum Concentration (Tmax) of DRSP|Tmax refers to the time after dosing when a drug attains its highest measurable concentration (Cmax). It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content|up to 168 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.||hours||Full Range|Median
832152|NCT01253187|Secondary|Mean Area Under the Concentration-time Curve From Administration up to 72h AUC(0-72h) of DRSP|The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample|up to 72 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.||ng·h/mL||95% Confidence Interval|Geometric Mean
832153|NCT01253187|Secondary|Time to Reach Maximum Concentration (Tmax) of EE|Tmax refers to the time after dosing when a drug attains its highest measurable concentration (Cmax). It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content|up to 96 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.||hours||Full Range|Median
832154|NCT01253187|Primary|Mean Area Under the Concentration-time Curve From Administration to the Last Measurement [AUC(0-tlast)] of L-5-methyl-THF (Baseline Uncorrected) Incl. Bioequivalence (BE) Evaluation|The baseline uncorrected AUC is a measure of the systemic drug exposure provided by the treatment including the endogenous L-5-methyl-THF level. It is obtained by collecting a series of blood samples and measuring the concentrations of L-5-methyl-THF in each sample.|up to 12 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.||nmol·h/L||95% Confidence Interval|Geometric Mean
832155|NCT01253187|Primary|Mean Maximum Concentration (Cmax) of L-5-methyl-THF (Baseline Uncorrected) Incl. Bioequivalence (BE) Evaluation|The baseline uncorrected Cmax is a measure of the highest measured drug concentration including the endogenous L-5-methyl-THF level. It is obtained by collecting a series of blood samples and measuring the concentrations of L-5-methyl-THF in each sample.|up to 12 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.||nmol/L||95% Confidence Interval|Geometric Mean
832173|NCT01253304|Primary|Pharmacokinetics: AUC From Time Zero to Infinity (AUC[0-infinity])|This measure was calculated using non-compartmental analysis techniques.|Predose to 336 hours postdose|Participants who received at least one dose of study drug (LY2189265) with evaluable concentration data.||nanograms times hr/milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
832156|NCT01253187|Primary|Mean Area Under the Concentration-time Curve From Administration to the Last Measurement [AUC(0-tlast)] of L-5-methyl-THF (Baseline Corrected) Incl. Bioequivalence (BE) Evaluation|The baseline corrected AUC is a measure of the systemic drug exposure provided by the treatment excluding the endogenous L-5-methyl-THF level. It is obtained by collecting a series of blood samples, measuring the concentrations of L-5-methyl-THF in each sample and by subtracting the pre-treatment concentration.|up to 12 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.||nmol·h/L||95% Confidence Interval|Geometric Mean
832157|NCT01253187|Primary|Mean Maximum Concentration (Cmax) of L-5-methyl-THF (Baseline Corrected) Incl. Bioequivalence (BE) Evaluation|The baseline corrected Cmax is a measure of the highest measured drug concentration provided solely by the treatment after subtracting endogenous L-5-methyl-THF level. It is obtained by collecting a series of blood samples, measuring the concentrations of L-5-methyl-THF in each sample and by subtracting the pre-treatment concentration.|up to 12 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.||nmol/L||95% Confidence Interval|Geometric Mean
832158|NCT01253187|Primary|Mean Area Under the Concentration-time Curve From Administration to the Last Measurement [AUC(0-tlast)] of DRSP Incl. Bioequivalence (BE) Evaluation|The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample|up to 168 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.||ng·h/mL||95% Confidence Interval|Geometric Mean
832159|NCT01253187|Primary|Mean Maximum Concentration (Cmax) of DRSP Incl. Bioequivalence (BE) Evaluation|Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample|up to 168 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.||ng/mL||95% Confidence Interval|Geometric Mean
832160|NCT01253187|Primary|Mean Area Under the Concentration-time Curve From Administration to the Last Measurement [AUC(0-tlast)] of EE Incl. Bioequivalence (BE) Evaluation|The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample|up to 96 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.||pg·h/mL||95% Confidence Interval|Geometric Mean
832161|NCT01253187|Primary|Mean Maximum Concentration (Cmax) of EE Incl. Bioequivalence (BE) Evaluation|Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample|up to 96 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.||pg/mL||95% Confidence Interval|Geometric Mean
832162|NCT01253265|Secondary|Pharmacokinetics - Time of Maximum Observed Drug Concentration (Tmax) at Steady State (ss)|tmax,ss = time of maximum observed drug concentration (tmax) at steady state (ss)|Week 10 pre-dose up to 2 weeks post-dose (Week 12)|All randomized participants with analyzable pharmacokinetic data.||days||Full Range|Median
832163|NCT01253265|Secondary|Pharmacokinetics - Maximum Plasma Drug Concentration (Cmax) at Steady State (ss)|Cmax,ss = maximum observed drug concentration (Cmax) at steady state (ss)|Week 10 pre-dose up to 2 weeks post-dose (Week 12)|All randomized participants with analyzable pharmacokinetic data.||micrograms per milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
832164|NCT01253265|Secondary|Pharmacokinetics - Area Under the Concentration-time Curve (AUC) at Steady State (ss)|AUCτ,ss= area under the concentration versus time curve (τ) at steady state (ss)|Week 10 pre-dose up to 2 weeks post-dose (Week 12)|All randomized participants with analyzable pharmacokinetic data.||micrograms•day per milliliter(μg•day/mL)||Geometric Coefficient of Variation|Geometric Mean
832165|NCT01253265|Secondary|Change From Baseline to 26 Week Endpoint in Lymphocyte Counts||Baseline, 26 weeks|All randomized participants.||10^9 cells per liter (GI/L)||Full Range|Median
832166|NCT01253265|Secondary|Change From Baseline to 26 Week Endpoint in Neutrophil Counts||Baseline, 26 weeks|All randomized participants.||10^9 cells per liter (GI/L)||Full Range|Median
832167|NCT01253265|Secondary|Percentage Change From Baseline to 16 Week Endpoint in Erythrocyte Sedimentation Rate (ESR)|Erythrocyte Sedimentation Rate (ESR) is a disease related biomarker and measured in millimeters per hour (mm/h).|Baseline, 16 weeks|All randomized participants.||percentage change in ESR||Full Range|Median
832168|NCT01253265|Secondary|Percentage Change From Baseline to 16 Week Endpoint in C-Reactive Protein|C-reactive protein (CRP) is a disease related biomarker and measured in milligrams per liter.|Baseline, 16 weeks|All randomized participants.||percentage change in C-Reactive Protein||Full Range|Median
832169|NCT01253265|Primary|Number of Participants With Clinically Significant Effects|Clinically significant events were defined as serious and other non-serious adverse events. A summary of serious and all other non-serious adverse events is located in the Reported Adverse Event module.|Baseline up to 26 weeks|All randomized participants.||participants|||Number
832170|NCT01253304|Primary|Pharmacokinetics: Apparent Volume of Distribution (Vz/F)|The apparent volume of distribution during the terminal phase after extra vascular administration is summarized. This measure was calculated using non-compartmental analysis techniques.|Predose to 336 hours postdose|Participants who received at least one dose of study drug (LY2189265) with evaluable LY2189265 concentration data.||liters (L)||Geometric Coefficient of Variation|Geometric Mean
832171|NCT01253304|Primary|Pharmacokinetics: Apparent Total Plasma Clearance (CL/F)|The apparent total body clearance of drug calculated after extra vascular administration is summarized. This measure was calculated using non-compartmental analysis techniques.|Predose to 336 hours postdose|Participants who received at least one dose of study drug (LY2189265) with evaluable LY2189265 concentration data.||liters/hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
832275|NCT01253811|Secondary|Clinical Laboratory Assessments: Haematology: Erythrocytes|Clinical laboratory values for erythrocytes collected from week 0 to end of trial visit.|Every 6th month, from week 0 to end of trial visit (week 173).|The safety analysis set included all subjects who received at least one dose of the trial product.||10^12 cells/L||Standard Deviation|Mean
832174|NCT01253304|Primary|Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to the Last Quantifiable Concentration (AUC[0-tlast])|This measure was calculated using non-compartmental analysis techniques.|Predose to 336 hours postdose|Participants who received at least one dose of study drug (LY2189265) with evaluable LY2189265 concentration data.||nanograms times hour/milliliter(ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
832175|NCT01253304|Primary|Pharmacokinetics: Time of Maximum Concentration (Tmax)|This measure was calculated using non-compartmental analysis techniques.|Predose to 336 hours postdose|Participants who received at least one dose of study drug (LY2189265) with evaluable LY2189265 concentration data.||hours||Full Range|Median
832176|NCT01253304|Primary|Pharmacokinetics: Maximum Observed Concentration (Cmax)|This measure was calculated using non-compartmental analysis techniques.|Predose to 336 hours postdose|Participants who received at least one dose of study drug (LY2189265) with evaluable concentration data.||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
832177|NCT01253317|Secondary|Change in Social Avoidance Subscale Scores on the ADAMS From Pre-OLE to Post-OLE|The Anxiety Depression and Mood Scale (ADAMS) is completed by the parent/caregiver and consists of 29 items which are scored on a 4-point rating scale that combines frequency and severity ratings. The Social Avoidance subscale [0 = best; 20 = worst] of the ADAMS is reported as a secondary outcome measure. A negative value indicates a decrease in the Social Avoidance subscale; which represents an improved outcome.|Pre-OLE (visit 1) and post-OLE (after 20 weeks of IGF-1 therapy)|The ADAMS was not completed during the MAD.||units on a scale||Standard Error|Mean
832178|NCT01253317|Secondary|Change From Pre-MAD Apnea Index at Post-OLE|Apnea indices were compared from pre-MAD (prior to initiating treatment) to post-OLE (after 20 weeks of IGF-1 therapy). A negative value indicates a reduction in apnea index; representing an improved outcome. Apnea Index is defined as the number of apneas (≥ 10 seconds in length) occuring within one hour. The Apnea Index is calculated by dividing the number of qualifying apneic events by the number of hours in which they occurred. An apnea index greater than or equal to 5 is considered clinically significant by the American Academy of Sleep Medicine (AASM).|pre-MAD (baseline) to post-OLE (after 20 weeks of IGF-1 treatment)|Two subjects enrolled in the MAD did not continue participation in the OLE and one subject was excluded from the analysis because, upon further medical record review, she did not meet diagnostic criteria for Rett syndrome.||apneas per hour||Standard Error|Mean
832179|NCT01253317|Primary|Pharmacokinetic (PK) Profile - Areas Under the Curve (AUCt)||60 minutes pre-dose and 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 8.0, and 12.0 hours post-dose on days 1, 8, 15 and 29.|||ng.h/mL||Standard Error|Mean
832180|NCT01253317|Primary|Adverse Events||biweekly during the MAD and every five weeks during the OLE|Subjects that had the same adverse event more than once are counted only one time using the closest relationship to study medication.||Adverse events|||Number
832181|NCT01253343|Primary|Salivary Hormone Correlation With Brief Rating of Aggression by Children and Adolescent (BRACHA) Score.|We collected three saliva samples from each participant over a 24-hour period on one of the initial three hospital days to determine the peripheral concentrations of cortisol, dehydroepiandrosterone (DHEA), and testosterone. We then compared these levels with the participants BRACHA score. We wanted to determine if hormone concentrations could improve the BRACHA's accuracy of predicting pediatric aggression during psychiatric hospitalization.|Collected on one or two days|The number of participants for analysis was supposed to be 24 based on Kelsey's sample size calculation (Kelsey et al., Methods in Observational Epidemiology, 2nd Edition, Table 12-15). However, due to funding constraints we only collected samples from 17 participants.||pg/mL||Standard Deviation|Mean
832182|NCT01253343|Primary|Salivary Hormone Correlation With Brief Rating of Aggression by Children and Adolescent (BRACHA) Score|We collected three saliva samples from each participant over a 24-hour period on one of the initial three hospital days to determine the peripheral concentrations of cortisol, dehydroepiandrosterone (DHEA), and testosterone. We then compared these levels with the participants BRACHA score. We wanted to determine if hormone concentrations could improve the BRACHA's accuracy of predicting pediatric aggression during psychiatric hospitalization.|Collected on one or two days|The number of participants for analysis was supposed to be 24 based on Kelsey's sample size calculation (Kelsey et al., Methods in Observational Epidemiology, 2nd Edition, Table 12-15). However, due to funding constraints we only collected samples from 17 participants.||ul/dL||Standard Deviation|Mean
832183|NCT01253369|Secondary|Objective Response Rate|The objective response rate (ORR) was defined as achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better objective response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.|Disease was evaluated radiologically at baseline and every 8 weeks on treatment; Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 3 cycles range (1-20).|The analysis dataset is comprised of evaluable patients. Patients who had measurable disease at baseline, received at least 1 cycle of therapy and had their disease re-evaluated were considered evaluable for response.||proportion of patients||80% Confidence Interval|Number
832184|NCT01253369|Primary|8-Week Progression-Free Rate|The 8-week progression free rate (PFR) was defined as achieving complete response (CR), partial response (PR) or stable disease (SD) based on RECIST 1.1 criteria by the time of the first disease assessment (8 weeks). Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions; PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD; and SD is neither sufficient decrease to qualify as PR nor sufficient increase to qualify as progressive disease (PD). PD is at least a 20% increase in sum LD, taking as reference the smallest sum on study with at least 5 mm absolute increase. Response needed confirmation within 4 weeks. For non-target lesions, progression-free means no new lesions or unequivocal progression on existing non-target lesions.|For this endpoint, disease was evaluated radiologically at baseline and week 8 on treatment; Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 3 cycles range (1-20).|The analysis dataset is comprised of evaluable patients. Patients who had measurable disease at baseline, received at least 1 cycle of therapy and had their disease re-evaluated were considered evaluable for response.||proportion of patients||80% Confidence Interval|Number
832185|NCT01253408|Primary|Colonic Transit Geometric Center at 24 Hours|The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.|24 hours|||units on a scale||Standard Deviation|Mean
832186|NCT01253408|Secondary|Gastric Emptying at 2 and 4 Hours|Proportion of stomach contents emptied at a 2 and 4 hours.|2, 4 hours|||proportion of stomach contents||Standard Deviation|Mean
832187|NCT01253408|Secondary|Ascending Colon Emptying T 1/2|Ascending colon emptying t1/2 will be estimated by power exponential analysis of the proportionate emptying over time of counts from the colon. The primary data for this analysis will be the proportion of decay and depth-corrected counts in the ascending colon on the hourly scans on the first day of transit measurement and the 48 hour data.|48 hours after radiolabeled meal was ingested|||hours||Standard Deviation|Mean
832188|NCT01253408|Secondary|Colonic Filling at 6 Hours|Percent of the radio-labeled meal that reached the colon at 6 hours, indirectly reflecting small bowel transit time.|6 hours after radiolabeled meal was ingested|||percentage of meal||Standard Deviation|Mean
832189|NCT01253408|Secondary|Gastric Emptying Half-Time (t1/2)|The time for half of the ingested solids or liquids to leave the stomach.|Approximately 2 hours after radiolabel meal is ingested|||minutes||Standard Deviation|Mean
832190|NCT01253408|Secondary|Colonic Transit Geometric Center|The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.|28, 32, and 48 hours|||units on a scale||Standard Deviation|Mean
832191|NCT01253447|Secondary|Maximum Percentage Change in Apoptosis|Peripheral blood AML cells (total 2 x 10^6) used to determine induction of apoptosis in AML stem cells by 4-color flow cytometry assay (CD34/CD38/CD123/annexin). Two-sample t-test conducted to compare changes between the responders and non-responders. Responders are participants who obtain a CR, CRp, or PR, with or without cytogenetic response.|Baseline to 12 courses||||||
832192|NCT01253447|Primary|Treatment-related Non-hematological Toxicity|Toxicity assessed using the NIH-NCI Common Terminology Criteria for Adverse Events, version 4.0 (CTCAEv4.0)|Up to 30 days post-treatment||||||
832193|NCT01253447|Primary|Number of Participants With a Response of CR, CRp, or PR|Responses defined by International Working Group (IWG) 2003 Response Criteria: Morphologic Complete Response (CR): Peripheral blood counts: No circulating blasts, Neutrophil count >/= 1.0 x10^9/L, Platelet count >/= 100 x10^9/L; Bone marrow aspirate and biopsy: </= 5% blasts, No detectable Auer rods, No extramedullary leukemia. Partial Response (PR): No circulating blasts, Neutrophil count >/=1.0 x10^9/L, Platelet count >/= 100 x10^9/L, >/= 50 % reduction in bone marrow blast to 6% to 25%, or blasts </= 5% if Auer rods are present. Morphologic CR with incomplete count recovery (CRp): All criteria for CR except for residual neutropenia (<1x10^9/L) or thrombocytopenia (<100 x10^9/L).|12 weeks of treatment|No participant was not evaluable for response.||participants|||Number
832194|NCT01253525|Secondary|Ramucirumab Steady State Volume of Distribution (Vss) for Cycle 4|Due to sparse pharmacokinetic sampling Vss for ramucirumab (IMC-1121B) could not be calculated in Cycle 4.|Cycle 4: Pre-infusion, Day 1 of 28-day cycle|Zero participants were analyzed.|||||
832195|NCT01253525|Secondary|Ramucirumab Clearance (CL) for Cycle 4|Due to sparse pharmacokinetic sampling CL for ramucirumab (IMC-1121B) could not be calculated in Cycle 4.|Cycle 4: Pre-infusion, Day 1 of 28-day cycle|Zero participants were analyzed.|||||
832196|NCT01253525|Secondary|Ramucirumab Half-Life (t 1/2) for Cycle 4|Due to sparse pharmacokinetic sampling t1/2 for ramucirumab (IMC-1121B) could not be calculated in Cycle 4.|Cycle 4: Pre-infusion, Day 1 of 28-day cycle|Zero participants were analyzed.|||||
832197|NCT01253525|Secondary|Ramucirumab Area Under the Concentration Time Curve (AUC) for Cycle 4|Due to sparse pharmacokinetic sampling AUC within the dosing interval (0-τ) for ramucirumab (IMC-1121B) could not be calculated in Cycle 4.|Cycle 4: Pre-infusion, Day 1 of 28-day cycle|Zero participants were analyzed.|||||
832198|NCT01253525|Secondary|Ramucirumab Maximum Serum Concentration (Cmax) for Cycle 4|Due to sparse pharmacokinetic sampling ramucirumab (IMC-1121B) Cmax could not be calculated in Cycle 4.|Cycle 4: Pre-infusion, Day 1 of 28-day cycle|Zero participants were analyzed.|||||
832199|NCT01253525|Secondary|Ramucirumab Steady State Volume of Distribution (Vss) for Cycle 3|Due to sparse pharmacokinetic sampling Vss for ramucirumab (IMC-1121B) could not be calculated in Cycle 3.|Cycle 3: Pre-infusion, Day 1 of 28-day cycle|Zero participants were analyzed.|||||
832200|NCT01253525|Secondary|Ramucirumab Clearance (CL) for Cycle 3|Due to sparse pharmacokinetic sampling CL could not be calculated for ramucirumab (IMC-1121B) in Cycle 3.|Cycle 3: Pre-infusion, Day 1 of 28-day cycle|Zero participants were analyzed.|||||
832201|NCT01253525|Secondary|Ramucirumab Half-Life (t 1/2) for Cycle 3|Due to sparse pharmacokinetic sampling ramucirumab (IMC-1121B) t1/2 could not be calculated in Cycle 3.|Cycle 3: Pre-infusion, Day 1 of 28-day cycle|Zero participants were analyzed.|||||
832202|NCT01253525|Secondary|Ramucirumab Area Under the Concentration Time Curve (AUC) for Cycle 3|Due to the sparse pharmacokinetic sampling ramucirumab (IMC-1121B) AUC within the dosing interval (0-τ) could not be calculated in Cycle 3.|Cycle 3: Pre-infusion, Day 1 of 28-day cycle|Zero participants were analyzed.|||||
832203|NCT01253525|Secondary|Ramucirumab Maximum Serum Concentration (Cmax) for Cycle 3|Due to sparse pharmacokinetic sampling ramucirumab (IMC-1121B) Cmax could not be calculated in Cycle 3.|Cycle 3: Pre-infusion, Day 1 of 28-day cycle|Zero participants were analyzed.|||||
832204|NCT01253525|Secondary|Ramucirumab Steady State Volume of Distribution (Vss) for Cycle 2|Vss [distribution of ramucirumab (IMC-1121B) in in the body at steady state] is not calculated for multiple doses of ramucirumab (IMC-1121B).|Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle|Zero participants were analyzed.|||||
832205|NCT01253525|Secondary|Ramucirumab Clearance (CL) for Cycle 2|CL [the volume of plasma or serum cleared of ramucirumab (IMC-1121B) per unit time] at steady state after multiple doses of ramucirumab (IMC-1121B).|Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle|All enrolled participants who received any quantity of study drug and had evaluable CL values.||liters/hour (L/h)||Standard Deviation|Mean
832206|NCT01253525|Secondary|Ramucirumab Half-Life (t1/2) for Cycle 2|Terminal t1/2 [the time it takes for the concentration of ramucirumab (IMC-1121B) in plasma or serum to decline by 50%] after multiple doses of ramucirumab(IMC-1121B).|Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle|All enrolled participants who received any quantity of study drug and had evaluable t1/2 values.||hours (h)||Full Range|Median
832207|NCT01253525|Secondary|Ramucirumab Area Under the Concentration Time Curve (AUC) for Cycle 2|AUC within the dosing interval (0-τ) after multiple doses of ramucirumab (IMC-1121B).|Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle|All enrolled participants who received any quantity of study drug and had evaluable AUC 0-τ values.||micrograms*hour/milliliter (µg*h/mL)||Standard Deviation|Mean
832208|NCT01253525|Secondary|Ramucirumab Maximum Serum Concentration (Cmax) for Cycle 2|Cmax after multiple doses of ramucirumab (IMC-1121B).|Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle|All enrolled participants who received any quantity of study drug and had evaluable Cmax values.||micrograms/milliliter (µg/mL)||Standard Deviation|Mean
832209|NCT01253525|Secondary|Ramucirumab Steady State Volume of Distribution (Vss) for Cycle 1|Vss [distribution of ramucirumab (IMC-1121B) in the body at steady state] after a single dose of ramucirumab (IMC-1121B).|Cycle 1: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle|All enrolled participants who received any quantity of study drug and had evaluable Vss values.||liters (L)||Standard Error|Mean
832210|NCT01253525|Secondary|Ramucirumab Clearance (CL) or Cycle 1|CL [the volume of plasma or serum cleared of ramucirumab (IMC-1121B) per unit time] after a single dose of ramucirumab (IMC-1121B).|Cycle 1: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle|All enrolled participants who received any quantity of study drug and had evaluable CL values.||liters/hour (L/h)||Standard Deviation|Mean
832211|NCT01253525|Secondary|Ramucirumab Half-Life (t1/2) for Cycle 1|Terminal t1/2 (the time it takes for the concentration of ramucirumab (IMC-1121B) in plasma or serum to decline by 50%) after a single dose of ramucirumab (IMC-1121B).|Cycle 1: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle|All enrolled participants who received any quantity of study drug and had evaluable t1/2 values.||hours (h)||Full Range|Median
832212|NCT01253525|Secondary|Ramucirumab Area Under the Concentration Time Curve (AUC) for Cycle 1|AUC from time 0 to infinity (0-∞) after a single dose of ramucirumab (IMC-1121B).|Cycle 1 Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle|All enrolled participants who received any quantity of study drug and had evaluable AUC0-∞ values.||micrograms*hour/milliliter (µg*h/mL)||Standard Deviation|Mean
832213|NCT01253525|Secondary|Serum Anti-Ramucirumab Antibody Assessment (Immunogenicity)|The percentage of participants who were treatment-emergent positive for anti-ramucirumab (IMC-1121B) antibodies.|Cycle 1 through Cycle 5 (28-day cycles)|All enrolled participants who received at least 1 dose of study drug and were analyzed for anti-ramucirumab (IMC-1121B) antibodies.||percentage of participants|||Number
832214|NCT01253525|Secondary|Ramucirumab Maximum Serum Concentration (Cmax) for Cycle 1|Cmax after a single dose of ramucirumab (IMC-1121B).|Cycle 1 Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle|All enrolled participants who received any quantity of study drug and had evaluable Cmax values.||micrograms/milliliter (µg/mL)||Standard Deviation|Mean
832215|NCT01253525|Primary|Number of Participants With Serious Adverse Events (SAEs)|The number of participants who experienced SAEs that were considered to be related to ramucirumab [RAM (IMC-1121B)] or paclitaxel (PAC). A summary of SAEs and all other non-SAEs, regardless of causality, is located in the Reported Adverse Events module.|Up to 47 weeks post baseline|All enrolled participants who received any quantity of study drug.||participants|||Number
832216|NCT01253525|Primary|Number of Participants With Adverse Events (AEs)|The number of participants who experienced AEs of any grade, AEs of Grade ≥3 or AEs resulting in death that were considered to be related to ramucirumab [RAM (IMC-1121B)] or paclitaxel (PAC). A summary of serious adverse events (SAEs) and all other non-SAEs, regardless of causality, is located in the Reported Adverse Events module.|Up to 47 weeks post baseline|All enrolled participants who received any quantity of study drug.||participants|||Number
832217|NCT01253525|Primary|Number of Participants With a Dose-Limiting Toxicity (DLT) During Cycle 1|DLT based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCICTCAE v4.02) in Cycle (Cy) 1 due to study drug (SD) with (w/): Grade (Gr) ≥3 neutropenia w/fever ≥38.5°C or w/bacteremia or sepsis, thrombocytopenia w/bleeding and platelet substitution, prothrombin and/or partial thromboplastin time w/no anticoagulation, hyperbilirubinemia; Gr 4: neutropenia >5 days, thrombocytopenia, Gr 4 or uncontrollable hypertension QTc>500 milliseconds (ms) or increase ≥100 ms increase in 24 hours after SD or significant arrhythmia in this period; Gr ≥3 nonhematologic toxicity (tox), excluding Gr 3 hypersensitivity, hypertension, injection-site reaction, arthralgia/myalgia, asthenia/fatigue, diarrhea w/out loperamide/nausea/vomiting w/out antiemetic and transient aminotransferase elevation. SD tox=delay >1 week in ramucirumab (RAM) dose or omission of 1 dose of RAM or 2 paclitaxel doses due to tox in Cy 1 or delay >2 weeks between Cy 1 and Cy 2 due to persistent tox.|Cycle 1 of 28-day cycle|All enrolled participants who complete the first cycle of study drug or discontinued study drug due to a DLT during Cycle 1.||participants|||Number
832218|NCT01253564|Secondary|Percentage of Participants With Improvement in Physician's Assessment of Global Performance Status|Physician’s Assessment of Global Performance Status was assessed on 7 point scale (1- Very much better, 2-Much better, 3-A little better, 4-No change, 5-A little worse, 6-Much worse, 7- Very much worse). An improvement was classed as a difference from baseline of at least -1 point. Percentage of participants with 95% Clopper-Pearson CI were reported for participants with improvement in Physician's Assessment of Global Performance Status at any visit.|Baseline, Day 1 of every 28-day cycle, at end of study and at the 28-day follow-up visit (up to 16 months)|Safety population.||percentage of participants||95% Confidence Interval|Number
832219|NCT01253564|Secondary|Percentage of Participants With Improvement in Visual Analog Scale (VAS) Assessment of Pain|VAS is a measure of pain intensity. The participant was asked to mark on a 100 mm line where their pain level was on the day they completed the scale. The beginning of the line represented no pain and the end of the line represented maximum pain. Total score ranged from 0 - 100. Reported values are decrease in VAS of greater than (>) 20 mm or >30 mm from baseline.|Baseline; Day 1 of Cycles 2-8 (28-day cycle) and at the end of study visit (up to 16 months)|Safety population. Here, 'n' signifies number of participants with available data for specified category.||percentage of participants|||Number
832331|NCT01254331|Secondary|Percentage of Participants Experiencing Fatigue||Baseline and Weeks 4, 8, 12, 16, 20, and 24|Safety population; n=number of participants analyzed for the given parameter at the specified visit||percentage of participants|||Number
832220|NCT01253564|Secondary|Percentage of Participants With Improvement in Total Daily Dose of Narcotic Pain Analgesic|An improvement in narcotic pain analgesics was defined as a dose reduction of at least 33% of baseline dose for at least 28 days or stopping use completely.|Baseline, every week during the first 8 weeks and every second week thereafter up to last dose (0.1 to 11.3 months) plus 28 days|Safety Population||percentage of participants|||Number
832221|NCT01253564|Secondary|Percentage of Participants With Improvement in Total Daily Dose of Corticosteroids|An improvement in corticosteroid dose was defined as a dose reduction of at least 33% of baseline dose for at least 28 days or stopping use completely. Percentage of participants and 95% Clopper-Pearson CI are reported.|Baseline, every week during the first 8 weeks and every second week thereafter up to last dose (0.1 to 11.3 months) plus 28 days|Safety Population.||percentage of participants||95% Confidence Interval|Number
832222|NCT01253564|Secondary|Overall Survival (OS)|OS was defined as the time from the date of first treatment to the date of death, regardless of the cause of death. Participants who discontinued the study treatment for any reason other than withdrawal of consent were continued to be followed for survival. The end of study occurred when all participants had been followed for a period of 6 months, had died, withdrawn consent or were lost to follow-up, whichever occurred first. OS was calculated by Kaplan-Meier estimates.|From start of treatment up to end of the study and every 3 months during follow up (up to 16 months)|Safety population.||months||95% Confidence Interval|Median
832223|NCT01253564|Secondary|Percentage of Participants Who Died|Percentage of participants who died due to any reason are reported.|Baseline up to end of the study and every 3 months during follow-up (up to 16 months)|Safety Population.||percentage of participants|||Number
832224|NCT01253564|Secondary|Progression Free Survival (PFS)|PFS was defined as the time interval between the date of the first treatment and the date of progression or death from any cause, whichever occurred first. Disease progression (according to RECIST version 1.1) was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study or absolute increase and at least 5 mm, progression of existing non-target lesions, or presence of new lesions. PFS was calculated by Kaplan-Meier estimates separately for brain, other sites (extracranial) and whole body.|Baseline, Week 4, Week 8 and thereafter every eighth week until progressive disease, unacceptable toxicity, consent withdrawal, death or other reasons deemed by the investigator (up to 16 months)|Safety Population.||months||95% Confidence Interval|Median
832225|NCT01253564|Secondary|Percentage of Participants With Disease Progression or Death by Disease Site|Disease progression (according to RECIST version 1.1) was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study or absolute increase and at least 5 mm, progression of existing non-target lesions, or presence of new lesions. Percentage of participants with disease progression by brain, other sites (extracranial) and whole body are reported.|Baseline, Week 4, Week 8 and thereafter every 8th week until progressive disease, unacceptable toxicity, consent withdrawal, death or other reasons deemed by the investigator (up to 16 months)|Safety Population.||percentage of participants|||Number
832226|NCT01253564|Secondary|Time to New Lesion by Disease Site|Time to new lesions was defined as the interval between the date of first treatment and the date of first documentation of new lesions. Time to new lesion was calculated by Kaplan-Meier estimates separately for brain, other sites (extracranial) and whole body.|Baseline, Week 4, Week 8 and thereafter every eighth week until progressive disease, unacceptable toxicity, consent withdrawal, death or other reasons deemed by the investigator (up to 16 months)|Safety population. Here, ‘n’ signifies number of participants with measurable disease at baseline for specified category.||months||95% Confidence Interval|Median
832227|NCT01253564|Secondary|Duration of Stable Disease (SD) by Disease Site|Duration of SD was defined as the time between the first documented date of SD and date of PD or death from any cause. SD was defined (according to RECIST version 1.1) as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. PD was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. Duration of SD was calculated by Kaplan-Meier estimates separately for brain, other sites (extracranial) and whole body.|Baseline, Week 4, Week 8 and thereafter every 8th week until progressive disease, unacceptable toxicity, consent withdrawal, death or other reasons deemed by the investigator (up to 16 months)|Safety Population. Here, 'n' signifies number of participants with measurable disease at baseline for specified category.||months||95% Confidence Interval|Median
832228|NCT01253564|Secondary|Time to Response by Disease Site|Time to response was defined as the interval between the date of first treatment and the date of first documentation of CR or PR (whichever occurred first). CR and PR were assessed by investigator according to RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Time of response was calculated by Kaplan-Meier estimates separately for brain, other sites (extracranial) and whole body.|Baseline, Week 4, Week 8 and thereafter every 8th week until progressive disease, unacceptable toxicity, consent withdrawal, death or other reasons deemed by the investigator (up to 16 months)|Safety population. Here, 'n' signifies number of participants with measurable disease for specified category.||months||95% Confidence Interval|Median
832240|NCT01246791|Primary|Plasma Half Life (t1/2) on Norethisterone of NPC-01|Multiple blood samples will obtains at pretreatment(0 hour), 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0 and 24.0 hours after dosing of NPC-01(1mg norethisterone and 0.02mg ethinyl estradiol) and determination of plasma Half life (t1/2) of norethisterone that are active substances of NPC-01.|0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0, 24.0 hours after single dosing of NPC-01|||hours||Standard Deviation|Mean
832241|NCT01246791|Primary|Time to Peak Plasma Concentration (Tmax) on Ethinyl Estradiol of NPC-01|Multiple blood samples will obtains at pretreatment(0 hour), 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0 and 24.0 hours after dosing of NPC-01(1mg norethisterone and 0.02mg ethinyl estradiol) and determination of time to peak plasma concentration (Tmax) of ethinyl estradiol that are active substances of NPC-01.|0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0, 24.0 hours after single dosing of NPC-01|||hours||Standard Deviation|Mean
832229|NCT01253564|Secondary|Duration of Response by Disease Site|Duration of response was defined as the time interval between the date of the earliest qualifying response and the date of progressive disease (PD) or death, only for those participants whose best overall response was CR or PR. CR and PR were assessed by investigator according to RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. PD was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 millimeter (mm), progression of existing non-target lesions, or presence of new lesions. Duration of response was calculated by Kaplan-Meier estimates separately for brain, other sites (extracranial) and whole body.|Baseline, Week 4, Week 8 and thereafter every 8th week until progressive disease or death (up to 16 months)|Safety population. Here, 'n' signifies number of participants with best overall response of CR or PR for specified category.||months||95% Confidence Interval|Median
832230|NCT01253564|Secondary|Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) by Disease Site|Objective response was assessed by the investigator according to Response Evaluation Criteria in Solid Tumours (RECIST) (Version 1.1). CR was defined as disappearance of all target and non-target lesions and no new lesions. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Best overall response was calculated separately for brain, other sites (extracranial) and whole body. Percentage of participants with 95 percent (%) Clopper-Pearson confidence interval (CI) are reported.|Baseline, Week 4, Week 8 and thereafter every 8th week until progressive disease, unacceptable toxicity, consent withdrawal, death or other reasons deemed by the investigator (up to 16 months)|Safety population. Here, 'n' signifies the number of participants with measurable disease at baseline for specified category.||percentage of participants||95% Confidence Interval|Number
832231|NCT01253564|Primary|Percentage of Participants With Adverse Events (AEs)|AE:any unfavorable and unintended sign, symptom, or disease associated with use of study drug, regardless of relation to study drug. Pre-existing conditions that worsened and laboratory or clinical tests that resulted in change in treatment or discontinuation from study drug were reported as AEs. Serious AE: resulted in death, life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was congenital anomaly/birth defect or was medically significant. Grade-1:discomfort but no disruption of normal daily activity. Grade-2:discomfort sufficient to reduce or affect daily activity,no intervention indicated.Grade-3:inability to perform normal daily activity,intervention indicated.Grade-4:immediate threat to life or leading to permanent mental or physical condition that prevented performing normal daily activities.Grade 5: death. Any AE included participants with serious and non-serious AE.|From baseline up to last dose (0.1 to 11.3 months) plus 28 days|Safety Population.||percentage of participants|||Number
832232|NCT01253577|Secondary|Percentage of Sinuses That Developed Frank Polyposis|Frank polyposis means polyps grade 2 or 3, which was determined from video-endoscopies reviewed by a panel of independent blinded sinus surgeons.|30 days|All 105 subjects were present for this endpoint exam. However n=85 is the number of subjects where both sinus sides had video-endoscopies able to be graded by the independent panel.||percentage of sinuses||95% Confidence Interval|Mean
832233|NCT01253577|Primary|Percentage of Patients With Clinically Significant Increase in Intra-ocular Pressure|clinically significant IOP elevation is a change from baseline of >10 mm Hg on sinus side with drug-coated implant but not on side with control implant|90 days|Two patients did not have their ocular exam performed at day 90 (LTFU) but had ocular exams at earlier time points.||percentage of patients||95% Confidence Interval|Mean
832234|NCT01253577|Primary|Percentage of Sinuses Requiring Post-operative Intervention|Post-operative interventions include either need for surgical adhesion lysis or the need for oral steroids prescription, as determined from video-endoscopies reviewed by a panel of independent blinded sinus surgeons.|30-days|All 105 subjects were present for the primary endpoint exam. However n=96 is the number of subjects where both sinus sides had video-endoscopies able to be graded by the independent panel.||percentage of sinuses||95% Confidence Interval|Mean
832235|NCT01246791|Primary|Elimination Rate Constant (Kel) on Ethinyl Estradiol of NPC-01|Multiple blood samples will obtains at pretreatment(0 hour), 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0 and 24.0 hours after dosing of NPC-01(1mg norethisterone and 0.02mg ethinyl estradiol) and determination of elimination rate constant (kel) of ethinyl estradiol that are active substances of NPC-01.|0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0, 24.0 hours after single dosing of NPC-01|||hr^-1||Standard Deviation|Mean
832236|NCT01246791|Primary|Elimination Rate Constant (Kel) on Norethisterone of NPC-01|Multiple blood samples will obtains at pretreatment(0 hour), 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0 and 24.0 hours after dosing of NPC-01(1mg norethisterone and 0.02mg ethinyl estradiol) and determination of elimination rate constant (kel) of norethisterone that are active substances of NPC-01.|0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0, 24.0 hours after single dosing of NPC-01|||hr^-1||Standard Deviation|Mean
832237|NCT01246791|Primary|Mean Residence Time (MRT) on Ethinyl Estradiol of NPC-01|Multiple blood samples will obtains at pretreatment(0 hour), 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0 and 24.0 hours after dosing of NPC-01(1mg norethisterone and 0.02mg ethinyl estradiol) and determination of mean residence time (MRT) of ethinyl estradiol that are active substances of NPC-01.|0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0, 24.0 hours after single dosing of NPC-01|||hours||Standard Deviation|Mean
832238|NCT01246791|Primary|Mean Residence Time (MRT) on Norethisterone of NPC-01|Multiple blood samples will obtains at pretreatment(0 hour), 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0 and 24.0 hours after dosing of NPC-01(1mg norethisterone and 0.02mg ethinyl estradiol) and determination of mean residence time (MRT) of norethisterone that are active substances of NPC-01.|0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0, 24.0 hours after single dosing of NPC-01|||hours||Standard Deviation|Mean
832239|NCT01246791|Primary|Plasma Half Life (t1/2) on Ethinyl Estradiol of NPC-01|Multiple blood samples will obtains at pretreatment(0 hour), 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0 and 24.0 hours after dosing of NPC-01(1mg norethisterone and 0.02mg ethinyl estradiol) and determination of plasma Half life (t1/2) of ethinyl estradiol that are active substances of NPC-01.|0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0, 24.0 hours after single dosing of NPC-01|||hours||Standard Deviation|Mean
832242|NCT01246791|Primary|Time to Peak Plasma Concentration (Tmax) on Norethisterone of NPC-01|Multiple blood samples will obtains at pretreatment(0 hour), 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0 and 24.0 hours after dosing of NPC-01(1mg norethisterone and 0.02mg ethinyl estradiol) and determination of time to peak plasma concentration (Tmax) of norethisterone that are active substances of NPC-01.|0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0, 24.0 hours after single dosing of NPC-01|||hours||Standard Deviation|Mean
832243|NCT01246791|Primary|Peak Plasma Concentration (Cmax) on Ethinyl Estradiol of NPC-01|Multiple blood samples will obtains at pretreatment(0 hour), 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0 and 24.0 hours after dosing of NPC-01(1mg norethisterone and 0.02mg ethinyl estradiol) and determination of peak plasma concentration (Cmax) of ethinyl estradiol that are active substances of NPC-01.|0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0, 24.0 hours after single dosing of NPC-01|||pg/mL||Standard Deviation|Mean
832244|NCT01246791|Primary|Peak Plasma Concentration (Cmax) on Norethisterone of NPC-01|Multiple blood samples will obtains at pretreatment(0 hour), 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0 and 24.0 hours after dosing of NPC-01(1mg norethisterone and 0.02mg ethinyl estradiol) and determination of peak plasma concentration (Cmax) of norethisterone that are active substances of NPC-01.|0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0, 24.0 hours after single dosing of NPC-01|||ng/mL||Standard Deviation|Mean
832245|NCT01246791|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) on Ethinyl Estradiol of NPC-01|Multiple blood samples will obtains at pretreatment(0 hour), 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0 and 24.0 hours after dosing of NPC-01(1mg norethisterone and 0.02mg ethinyl estradiol) and determination of area under the plasma concentration versus time curve (AUC) of ethinyl estradiol that are active substances of NPC-01.|0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0, 24.0 hours after single dosing of NPC-01|||pg･hr/mL||Standard Deviation|Mean
832246|NCT01246791|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) on Norethisterone of NPC-01|Multiple blood samples will obtains at pretreatment(0 hour), 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0 and 24.0 hours after dosing of NPC-01(1mg norethisterone and 0.02mg ethinyl estradiol) and determination of area under the plasma concentration versus time curve (AUC) of norethisterone that are active substances of NPC-01.|0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0, 24.0 hours after single dosing of NPC-01|||ng･hr/mL||Standard Deviation|Mean
832247|NCT01246960|Other Pre-specified|Number of Participants With Adverse Events (AEs)|Reported are the number of participants who had ramucirumab/placebo-related: AEs, serious AEs (SAEs), AEs based on common terminology criteria for adverse events (CTCAE) ≥Grade 3, AEs = CTCAE Grade 5, as well as, AEs leading to treatment discontinuation and AEs resulting in death. A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.|Baseline through study completion (up to Month 28.3)|Safety population: randomized participants who received any quantity of study drug (Ramucirumab, mFOLFOX6, or placebo).||participants|||Number
832248|NCT01246960|Secondary|Number of Participants With Treatment-Emergent Anti-Ramucirumab Antibodies|Participants with treatment-emergent anti-ramucirumab antibodies were participants with a 4-fold increase (2 dilution increase) in immunogenicity titer over baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20).|Months 1, 2, 4, 6, and 8|Randomized participants who received any quantity of ramucirumab or placebo, and were evaluated for the presence of anti-ramucirumab antibodies.||participants|||Number
832249|NCT01246960|Secondary|Time to Disease Progression (TTP)|TTP was defined using RECIST v. 1.1 as the time from study randomization to the first date of PD. PD was a ≥20% increase in the sum of the diameters of target lesions with the sum demonstrating an absolute increase of ≥5 mm; the appearance of ≥1 new lesions or unequivocal progression of non-target lesions. TTP was censored at the date of last adequate tumor assessment if death was due to causes other than PD.|Randomization to measured PD (up to Month 25.0)|ITT population: all randomized participants. Thirty-five participants in the Ramucirumab and mFOLFOX6 treatment arm and 31 participants in the Placebo and mFOLFOX6 treatment arm were censored.||months||Full Range|Median
832250|NCT01246960|Secondary|Duration of Response|Duration of response was defined using RECIST v. 1.1 criteria as the time from the date criteria were met for the first objectively recorded CR or PR until the first date criteria for PD were met or death from any cause. CR was the disappearance of all lesions and pathological lymph node reduction in the short axis to <10 mm. PR was a ≥30% decrease in the sum of the diameters of target lesions. PD was a ≥20% increase in the sum of the diameters of target lesions with the sum demonstrating an absolute increase of ≥5 mm; the appearance of ≥1 new lesions or unequivocal progression of non-target lesions. Participants who were not known to have died and who did not have PD were censored at the date of the last tumor assessment prior to the date of any subsequent systemic anticancer therapy.|Time of first response to measured PD (up to Month 23.0)|Randomized participants who achieved an objective response of CR or PR. Eight participants in the Ramucirumab and mFOLFOX6 treatment arm and 8 participants in the Placebo and mFOLFOX6 treatment arm were censored.||months||95% Confidence Interval|Median
832251|NCT01246960|Secondary|Percentage of Participants Achieving an Objective Response (Objective Response Rate)|The percentage of participants who achieved a best overall response of partial response (PR) or complete response (CR) is reported. Response was defined using RECIST, v. 1.1 criteria. CR was the disappearance of all lesions and pathological lymph node reduction in the short axis to <10 mm. PR was a ≥30% decrease in the sum of the diameters of target lesions. The percentage of participants with objective response=(number of participants whose best overall response achieved was CR or PR/number of participants treated)*100.|Randomization to measured PD (up to Month 23.0)|ITT population: all randomized participants.||percentage of participants||95% Confidence Interval|Number
832252|NCT01246960|Secondary|Overall Survival (OS)|OS was defined as the time from randomization to death due to any cause. OS was censored at the date of the last follow-up visit for participants who were alive or lost to follow-up.|Randomization to date of death from any cause (up to Month 28.3)|ITT population: all randomized participants. Twenty-seven participants in the Ramucirumab and mFOLFOX6 treatment arm and 32 participants in the Placebo and mFOLFOX6 treatment arm were censored.||months||95% Confidence Interval|Median
832273|NCT01253811|Secondary|Physical Examinations|Number of subjects in percentage with changes in values of physical examinations from week 0 to end of trial visit were collected.|Week 0 to end of trial visit (week 173).|The safety analysis set included all subjects who received at least one dose of the trial product. Two abnormal physical examination findings related to skin and musculo-skeletal system were assessed as clinically significant by the investigator during the trial.||percentage of subjects|||Number
832253|NCT01246960|Primary|Progression-Free Survival (PFS)|PFS was defined using Response Evaluation Criteria in Solid Tumors [RECIST version (v.) 1.1] as the time from randomization to the first observation of progressive disease (PD) or death due to any cause, whichever came first. PD was a ≥20% increase in the sum of the diameters of target lesions with the sum demonstrating an absolute increase of ≥5 millimeters (mm); the appearance of ≥1 new lesions or unequivocal progression of non-target lesions. If a participant did not have a baseline disease assessment, PFS time was censored at the randomization date, regardless of whether or not PD or death was observed. Participants not known to have died or have objective PD were censored at the last post-baseline radiological assessment date.|Randomization to measured PD or date of death from any cause (up to Month 25.0)|ITT population: all randomized participants. Fourteen participants in the Ramucirumab and mFOLFOX6 treatment arm and 15 participants in the Placebo and mFOLFOX6 treatment arm were censored.||months||95% Confidence Interval|Median
832254|NCT01246973|Secondary|Percentage of Subjects With Moist Desquamation|Moist desquamation was measured by the presence of wet, patchy crusting, oozing, or ulcerated skin in areas where skin was peeling in sheets.|6 weeks|||percentage of participants|||Number
832255|NCT01246973|Primary|Mean Radiation Dermatitis Severity Score|The outcome measures will be the severity of radiation dermatitis, using the Radiation Dermatitis Score (RDS), at the end of treatment in each treatment arm. (Objective: To examine the efficacy of curcumin in preventing and/or reducing the severity of dermatitis in radiation treatment site in breast cancer patients). The RDS score ranges from 0-4 with higher scores indicating worse outcome.|6 weeks|||units on a scale||Standard Deviation|Mean
832256|NCT01246999|Secondary|Mean Peak Influenza B Virus Titer, Dose 2|After the second dose of vaccine, the virus titer from nasal secretions was measured in tissue culture on days 2, 4 and 7 and the highest titer from one of those three time points was reported.|days 2, 4 and 7|||log10 TCID(50)/ml||Standard Deviation|Mean
832257|NCT01246999|Secondary|Mean Peak H3N2 Virus Titer, Dose 2|After the second dose of vaccine, the virus titer from nasal secretions was measured in tissue culture on days 2, 4 and 7 and the highest titer from one of those three time points was reported.|days 2, 4 and 7|||log10 TCID(50)/ml||Standard Deviation|Mean
832258|NCT01246999|Secondary|Mean Peak H1N1 Virus Titer, Dose 2|After the second dose of vaccine, the virus titer from nasal secretions was measured in tissue culture on days 2, 4 and 7 and the highest titer from one of those three time points was reported.|days 2, 4 and 7|||log10 TCID(50)/ml||Standard Deviation|Mean
832259|NCT01246999|Secondary|Mean Peak Influenza B Virus Titer, Dose 1|After the first dose of vaccine, the virus titer from nasal secretions was measured in tissue culture on days 2, 4 and 7 and the highest titer from one of those three time points was reported.|days 2, 4 and 7|||log10 TCID(50)/ml||Standard Deviation|Log Mean
832260|NCT01246999|Secondary|Mean Peak H3N2 Virus Titer, Dose 1|After the first dose of vaccine, the virus titer from nasal secretions was measured in tissue culture on days 2, 4 and 7 and the highest titer from one of those three time points was reported.|days 2, 4 and 7|||log10 TCID(50)/ml||Standard Deviation|Log Mean
832261|NCT01246999|Secondary|Mean Peak H1N1 Virus Titer, Dose 1|After the first dose of vaccine, the virus titer from nasal secretions was measured in tissue culture on days 2, 4 and 7 and the highest titer from one of those three time points was reported.|days 2, 4 and 7|||log10 TCID(50)/ml||Standard Deviation|Log Mean
832262|NCT01246999|Primary|Number of Subjects Shedding Vaccine Virus of Each Subtype by PCR|Nasal washes were collected on days 2, 4 and 7 after vaccination. Nasal swab specimens were tested for the presence of vaccine viruses by quantitative viral culture in MDCK cells at 33º C and by real-time quantitative reverse-transcriptase polymerase chain reaction (qRT-PCR) amplification. The limit of detection of vaccine viruses was 10^0.6 tissue culture infectious doses (50%)/ml for virus culture and 10^0.4 tissue culture infectious doses (50%)/ml for qRT-PCR.|baseline to day 7|Outcome for shedding of live vaccine in all participants who received a live vaccine||participants|||Number
832263|NCT01247064|Secondary|Parental Perception of Improvement of Breathing After Study Medication||1 hour|||percentage of participants|||Number
832264|NCT01247064|Secondary|Oxygen Saturation Change||Baseline and 1 hour|||percent||95% Confidence Interval|Mean
832265|NCT01247064|Secondary|Respiratory Rate Change||Baseline and 1 hour|||breaths per minute||95% Confidence Interval|Mean
832266|NCT01247064|Secondary|Rate of Hospitalization||1 day|||percentage of participants|||Number
832267|NCT01247064|Primary|Respiratory Assessment Change Score (RACS)|The Respiratory Assessment Change Score (RACS) assesses change in respiratory status using the change in the Respiratory Distress Assessment Instrument (RDAI) and a standardized change in respiratory rate, with points being assigned by change increments of 10%. Thus, a change in respiratory rate of ≤5% from baseline counted as a change of 0 units, decrease/increase of 6% to 15% counted as improvement/deterioration of 1 unit, etc. The overall RACS is the arithmetic sum of the RDAI change and the standardized respiratory rate change between assessments with a decrease in RACS signifying improvement.|Baseline and 1 hour|||units on a scale||95% Confidence Interval|Mean
832268|NCT01247090|Primary|Change in Mean Interdialytic 44-hour Ambulatory Systolic Blood Pressure Over a 2 Week Follow-up Period||Baseline and Two Weeks|||mm Hg||Standard Deviation|Mean
832269|NCT01253811|Secondary|Rate (Number Per Subject Year) of All Bleeding Episodes Requiring Treatment With a FXIII Containing Product Other Than Recombinant Factor XIII.|The rate (number per subject year) of all spontaneous, traumatic and intracranial bleeding episodes requiring treatment with FXIII-containing products during the rFXIII treatment period was assessed for treatment period.|Weeks 0 to end of trial visit (week 173).|There were no bleeding episodes requiring treatment with a haemostatic agent (rFXIII) during the trial, which included subjects from full analysis set who received at least one dose of the trial product.|||||
832270|NCT01253811|Secondary|Vital Signs: Pulse|Values collected for pulse from week 0 to end of trial visit.|Week 0 to end of trial visit (week 173).|The safety analysis included all subjects who received at least one dose of the trial product.||beats/minute||Standard Deviation|Mean
832271|NCT01253811|Secondary|Vital Signs: Diastolic BP (Blood Pressure)|Values collected for diastolic BP from week 0 to end of trial visit.|Week 0 to end of trial visit (week 173).|The safety analysis set one dose of the trial product.||mmHg||Standard Deviation|Mean
832272|NCT01253811|Secondary|Vital Signs: Systolic BP (Blood Pressure)|Values collected for systolic BP from week 0 to end of trial visit.|Week 0 to end of trial visit (week 173).|The safety analysis set included all subjects who received at least one dose of the trial product.||mmHg||Standard Deviation|Mean
832276|NCT01253811|Secondary|Clinical Laboratory Assessments: Haematology: Thrombocytes|Clinical laboratory values for thrombocytes collected from week 0 to end of trial visit.|Every 6th month, from week 0 to end of trial visit (week 173).|The safety analysis set included all subjects who received at least one dose of the trial product.||10^9 cells/L||Standard Deviation|Mean
832277|NCT01253811|Secondary|Clinical Laboratory Assessments: Haematology: Leucocytes|Clinical laboratory values for leucocytes collected from week 0 to end of trial visit.|Every 6th month, from week 0 to end of trial visit (week 173).|The safety analysis set included all subjects who received at least one dose of the trial product.||10^9 cells/L||Standard Deviation|Mean
832278|NCT01253811|Secondary|Clinical Laboratory Assessments: Haematology: Haemoglobin|Clinical values for haemoglobin collected from week 0 to end of trial visit.|Every 6th month, from week 0 to end of trial visit (week 173).|The safety analysis set included all subjects who received at least one dose of the trial product.||mmol/L||Standard Deviation|Mean
832279|NCT01253811|Secondary|Clinical Laboratory Assessments: Biochemistry: Aspartate Aminotransferase (ASAT)|Clinical laboratory assessments for ASAT at week 24 to end of trial visit.|Every 6th month, from week 24 to end of trial visit (week 173).|The safety analysis set included all subjects who received at least one dose of the trial product.||IU/L||Standard Deviation|Mean
832280|NCT01253811|Secondary|Clinical Laboratory Assessments: Biochemistry: Alanine Aminotransferase (ALAT)|Clinical laboratory assessments for ALAT at week 24 to end of trial visit.|Every 6th month, from week 24 to end of trial visit (week 173).|The safety analysis set included all subjects who received at least one dose of the trial product.||IU/L||Standard Deviation|Mean
832281|NCT01253811|Secondary|Clinical Laboratory Assessments: Biochemistry: Urea|Clinical laboratory assessments for urea at week 24 to end ot trial visit.|Every 6th month, week 24 to end of trial visit (week 173).|The safety analysis set included all subjects who received at least one dose of the trial product.||mmol/L||Standard Deviation|Mean
832282|NCT01253811|Secondary|Clinical Laboratory Assessments: Biochemistry: Creatinine|Clinical laboratory assessments for creatinine at week 24 to end of trial visit.|Every 6th month, from week 24 to end of trial visit (week 173).|The safety analysis set included all subjects who received at least one dose of the trial product.||mmol/L||Standard Deviation|Mean
832283|NCT01253811|Secondary|Percentage of Subjects With Development of Anti-rFXIII Antibodies, Including Inhibitors.|All subjects who received rFXIII were monitored for the frequency of development of anti-rFXIII antibodies. Samples passed through 2 tiers of ELISA testing: an initial screen with a specific cut-off point (including ~5% false positives) and a second confirmatory assay for samples yielding a result above the screening cut-off point. If samples were confirmed as antibody positive in the confirmation assay, an inhibitor assay was also carried out to detect functional inhibitors.|Week 0 to end of trial visit (week 173).|The SAS included all subjects who received at least one dose of the trial product. There were no antibodies against rFXIII detected in any patient during the trial.||percentage of subjects|||Number
832284|NCT01253811|Primary|Number of Treatment Emergent (Serious and Non-serious) Adverse Events|An adverse event was described as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have a causal relationship with this treatment. Treatment emergent adverse events (serious and non-serious), defined as adverse events occurring from first trial product administration to the end of the subject’s participation in the trial.|Week 0 to end of trial visit (week 173) for a minimum period of 52 weeks.|The safety analysis set included all subjects who received at least one dose of the trial product.||number of events|||Number
832285|NCT01253824|Secondary|Comparing LH AUC of Menstrual Period During Study Drug Administration With Pre and Post Study Drug Administration (Baseline(BL)-Study Drug Administration(SDA), Follow up(FU)-Study Drug Administration(ADA))|LH was measured on day 3, 6, 9, 12, 15, 18, 21, 24 on 3 consecutive menstrual period (pre administration/Baseline(BL), study drug administration(SDA), post administration/follow up(FU)) and calculated AUC from these data|Day 3, 6, 9, 12, 15, 18, 21, 24 of menstrual cycles|||mIU･day/mL||Standard Deviation|Mean
832286|NCT01253824|Primary|Comparing Progesterone AUC of Menstrual Period During Study Drug Administration With Pre and Post Study Drug Administration (Baseline(BL)-Study Drug Administration(SDA), Follow up(FU)-Study Drug Administration(ADA))|Progesterone was measured on day 3, 6, 9, 12, 15, 18, 21, 24 on 3 consecutive menstrual period (pre administration/Baseline(BL), study drug administration(SDA), post administration/follow up(FU)) and calculated AUC from these data|Day 3, 6, 9, 12, 15, 18, 21, 24 of menstrual cycles|||ng･day/mL||Standard Deviation|Mean
832287|NCT01253824|Secondary|Comparing FSH AUC of Menstrual Period During Study Drug Administration With Pre and Post Study Drug Administration (Baseline(BL)-Study Drug Administration(SDA), Follow up(FU)-Study Drug Administration(ADA))|FSH was measured on day 3, 6, 9, 12, 15, 18, 21, 24 on 3 consecutive menstrual period (pre administration/Baseline(BL), study drug administration(SDA), post administration/follow up(FU)) and calculated AUC from these data|Day 3, 6, 9, 12, 15, 18, 21, 24 of menstrual cycles|||mIU･day/mL||Standard Deviation|Mean
832288|NCT01253824|Primary|Comparing Estradiol AUC of Menstrual Period During Study Drug Administration With Pre and Post Study Drug Administration (Baseline(BL)-Study Drug Administration(SDA), Follow up(FU)-Study Drug Administration(ADA))|Estradiol was measured on day 3, 6, 9, 12, 15, 18, 21, 24 on 3 consecutive menstrual period (pre administration/Baseline(BL), study drug administration(SDA), post administration/follow up(FU)) and calculated AUC from these data|Day 3, 6, 9, 12, 15, 18, 21, 24 of menstrual cycles|||pg･day/mL,||Standard Deviation|Mean
832289|NCT01253902|Secondary|Mean Tear Break Up Time (TBUT) at Week 12|Tear Break Up Time was analyzed using the average of the readings of both eyes. TBUT is defined as the time (seconds) required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film.|Week 12|Intent-to-treat (ITT) population included all participants who were randomized and received study medication.||Seconds||Standard Deviation|Mean
832290|NCT01253902|Secondary|Mean Corneal Staining With Fluorescein at Week 12|Corneal staining was analyzed using the average of the scores of both eyes. The cornea is the transparent front part of the eye which covers the iris and pupil. To detect the presence or absence of corneal puncta (tiny disruptions in the surface of the eye), fluorescein dye is administered into the eye and the eye is graded using a 5-point scale where 0=None (no puncta), 0.5=Trace (1-5 puncta), 1=Mild (6-20 puncta), 2=Moderate (>20 puncta) and 3=Severe (too many puncta to count).|Week 12|Intent-to-treat (ITT) population included all participants who were randomized and received study medication.||Score on a scale||Standard Deviation|Mean
832291|NCT01253902|Primary|Mean Conjunctival Hyperemia at Week 12|Conjunctival hyperemia was analyzed using the average of the scores of both eyes. Hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). Hyperemia was graded on a 5 point scale where 0=none (normal), 0.5=trace (trace flush reddish pink), 1=Mild (mild flush reddish color), 2=Moderate (bright red color) and 3=severe (deep bright diffuse redness).|Week 12|Intent-to-treat population (ITT) included all participants who were randomized to study medication.||Score on a scale||Standard Deviation|Mean
832292|NCT01254292|Secondary|User Satisfaction – Acceptability of the Administration of Study Treatment|The degree of user satisfaction was assessed at the end-of-study visit using an eight item questionnaire. One of the items assessed was acceptability of study treatment which was categorized into the following: acceptable without I/D, acceptable with some I/D, not acceptable with moderate I/D, and not acceptable with extreme I/D.|At 12 months|Full analysis set (only subjects with an assessment of these questions of the user satisfaction questionnaire at 12 months)||Participants|||Number
832293|NCT01254292|Secondary|User Satisfaction – Acceptability of the Administration of Study Treatment|The degree of user satisfaction was assessed at the end-of-study visit using an eight item questionnaire. One of the items assessed was acceptability of study treatment which was categorized into the following: acceptable without I/D, acceptable with some I/D, not acceptable with moderate I/D, and not acceptable with extreme I/D.|At 6 months|Full analysis set (only subjects with an assessment of these questions of the user satisfaction questionnaire at 6 months)||Participants|||Number
832294|NCT01254292|Other Pre-specified|Participants’ Evaluation of Pain During IUS Removal Procedure||Up to 36 months|Full analysis set (only subjects in the LCS12 arm with documented removal of the IUS)||Participants|||Number
832295|NCT01254292|Other Pre-specified|Investigator's Evaluation of IUS Removal Procedure||Up to 36 months|Full analysis set (only subjects in the LCS12 arm with documented removal of the IUS)||Participants|||Number
832296|NCT01254292|Other Pre-specified|Participants’ Evaluation of Pain During Successful IUS Insertion Procedure||Up to 18 months|Full analysis set||Participants|||Number
832297|NCT01254292|Other Pre-specified|Investigator's Evaluation of Successful IUS Insertion Procedure||Up to 18 months|Full analysis set||Participants|||Number
832298|NCT01254292|Other Pre-specified|Cumulative Number of Participants With Partial or Total Expulsion|Total expulsion is confirmed if the IUS is observed in the vagina, the IUS is not shown in the uterine cavity by ultrasound, and / or the subject confirms that the system was expelled. Partial expulsion is diagnosed if the IUS can be partially seen in the vagina or is displaced in the cervical canal.|Up to 18, 24, 36 months|Full analysis set||Participants|||Number
832299|NCT01254292|Secondary|Compliance Rate for Yasmin Pill Intake||Up to 18 months|Full analysis set||Percentage of participants|||Number
832300|NCT01254292|Secondary|Pearl Index (PI)|The Pearl Index was defined as the number of pregnancies per 100 woman years (WYs). Given the assumption that the number of pregnancies follows a Poisson distribution, the Pearl Index thus is the mean of this distribution.|Up to 18, 24, 36 months|Full analysis set||Pregnancies per 100 women years||95% Confidence Interval|Mean
832301|NCT01254292|Secondary|Cumulative Drop-out Rate|The drop-out rate is the amount of participants that could not complete the study for various reasons. Discontinuation rates due to the following reasons and overall discontinuations were calculated: • LCS12 expulsions • Bleeding pattern alterations • Bleeding pattern alterations with increased bleeding (amount) • Bleeding pattern alterations with decreased bleeding (amount) • Adverse Events The analyses described above were also done by parity. Furthermore, overall discontinuation rates were analyzed by Kaplan-Meier analyses and presented as cumulative half-yearly drop-out rates.|Up to 6, 12, 18, 24 and 36 months|Full analysis set||Percentage of participants|||Number
832302|NCT01254292|Secondary|EVAPIL-R Scores at 18 Months/EOS|The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, with higher values indicating more severe symptoms/less tolerability. The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.|At 18 months/EOS|Full analysis set (only subjects with an assessment of the EVAPIL questionnaire at 18 months/end of study where the scores could be calculated)||Scores on a scale||Standard Deviation|Mean
832303|NCT01254292|Secondary|EVAPIL-R Scores at 12 Months - Composite Score|The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, with higher values indicating more severe symptoms/less tolerability.|At 12 months|Full analysis set (only subjects with an assessment of the EVAPIL questionnaire at 12 months where the composite score could be calculated)||Scores on a scale||Standard Deviation|Mean
832304|NCT01254292|Secondary|EVAPIL-R Scores at 12 Months - Bother Score|The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, with higher values indicating more severe symptoms/less tolerability.|At 12 months|Full analysis set (only subjects with an assessment of the EVAPIL questionnaire at 12 months where the bother score could be calculated)||Scores on a scale||Standard Deviation|Mean
832305|NCT01254292|Secondary|EVAPIL-R Scores at 6 Months|The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, with higher values indicating more severe symptoms/less tolerability.|At 6 months|Full analysis set (only subjects with an assessment of the EVAPIL questionnaire at 6 months where the scores could be calculated)||Scores on a scale||Standard Deviation|Mean
832306|NCT01254292|Secondary|EVAPIL-R Scores at Screening - Bother Score|The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, , with higher values indicating more severe symptoms/less tolerability.|At screening|Full analysis set (only subjects with an assessment of the EVAPIL questionnaire at screening where the bother score could be calculated)||Scores on a scale||Standard Deviation|Mean
832307|NCT01254292|Secondary|EVAPIL-R Scores at Screening - Composite Score|The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, with higher values indicating more severe symptoms/less tolerability.|At screening|Full analysis set (only subjects with an assessment of the EVAPIL questionnaire at screening where the composite score could be calculated)||Scores on a scale||Standard Deviation|Mean
832308|NCT01254292|Secondary|User Satisfaction – Rating of Usual Menstrual Pain Intensity|The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.|At 18 months/EOS|Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study)||Participants|||Number
832309|NCT01254292|Secondary|User Satisfaction – Comparison of Menstrual Pain Intensity Between Now and Before Treatment|The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.|At 18 months/EOS|Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study)||Participants|||Number
832310|NCT01254292|Secondary|User Satisfaction – Satisfaction With Menstrual Bleeding Absence|The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.|At 18 months/EOS|Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study)||Participants|||Number
832311|NCT01254292|Secondary|User Satisfaction – Frequency of Experiencing Unexpected Bleeding|The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.|At 18 months/EOS|Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study)||Participants|||Number
832312|NCT01254292|Secondary|User Satisfaction – Satisfaction With Menstrual Bleeding Pattern|The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.|At 18 months/EOS|Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study)||Participants|||Number
832313|NCT01254292|Secondary|User Satisfaction – Amount of Menstrual Bleeding|The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.|At 18 months/EOS|Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study)||Participants|||Number
832314|NCT01254292|Secondary|User Satisfaction – Choices Upon Completion of the Study|The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.|At 18 months/EOS|Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study)||Participants|||Number
832315|NCT01254292|Secondary|User Satisfaction – Acceptability of the Administration of Study Treatment|The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.|At 18 months/EOS|Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study)||Participants|||Number
832316|NCT01254292|Secondary|Overall Satisfaction Rate at 12 Months (LOCF)|Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting “1. Very satisfied” or “2. Satisfied” for the above question.|At 12 months|Full analysis set (only subjects with an assessment of overall satisfaction rating at 12 months)||Percentage of participants|||Number
832317|NCT01254292|Secondary|Overall Satisfaction Rate at 6 Months (LOCF)|Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting “1. Very satisfied” or “2. Satisfied” for the above question.|At 6 months|Full analysis set (only subjects with an assessment of overall satisfaction rating at 6 months or before)||Percentage of participants|||Number
832318|NCT01254292|Secondary|Overall Satisfaction Rating by the 5-point Likert Item at End of Study (EOS)|"Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting “1. Very satisfied” or “2. Satisfied” for the above question.
The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase."|At 18 months/EOS|Full analysis set (only subjects with an assessment of overall satisfaction rating at 18 months/end of study)||Percentage of participants|||Number
832681|NCT01250730|Primary|Metabolite to Parent Ratio AUC(0-inf)|The metabolic ratio (MR) is calculated by first converting the AUC(0-inf) for both crizotinib and metabolite (PF-06260182) from mass units to molar units.|0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose|||ratio||Standard Deviation|Geometric Mean
832319|NCT01254292|Secondary|Overall Satisfaction Rating by the 5-point Likert Item at 18 Months|Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting “1. Very satisfied” or “2. Satisfied” for the above question.|At 18 months|Full analysis set (only subjects with an assessment of overall satisfaction rating at 18 months)||Percentage of participants|||Number
832320|NCT01254292|Secondary|Overall Satisfaction Rating by the 5-point Likert Item at 12 Months|Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting “1. Very satisfied” or “2. Satisfied” for the above question.|At 12 months|Full analysis set (only subjects with an assessment of overall satisfaction rating at 12 months)||Percentage of participants|||Number
832321|NCT01254292|Secondary|Overall Satisfaction Rating by the 5-point Likert Item at 6 Months|Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting “1. Very satisfied” or “2. Satisfied” for the above question.|At 6 months|Full analysis set (only subjects with an assessment of overall satisfaction rating at 6 months)||Percentage of participants|||Number
832322|NCT01254292|Primary|Overall Satisfaction Rate at 18 Months (Last Observation Carried Forward, LOCF)|Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting “1. Very satisfied” or “2. Satisfied” for the above question.|At 18 months|Full analysis set (only subjects with at least one assessment of the overall satisfaction rating)||Percentage of participants|||Number
832323|NCT01254305|Primary|Change in Patient Global Impressions of Severity (PGI-S) for Fatigue Score|The PGI-S is a clinician-rated scale that rates was used to rate the severity of the patient’s current state of overall fatigue. Patients were rated on a scale from 1 to 7, with 1 indicating no symptoms of fatigue and 7 indicating extreme fatigue.|From Baseline to Week 8|"The Randomized Population consisted of 262 patients, with 251 patients who took at least 1 dose of double-blind treatment to comprise the Safety population.
The Intent-to-Treat (ITT) Population consisted of 248 patients in the Safety Population who had a baseline and at least 1 postbaseline assessment of either the CGI-S or PGI-I fatigue score."||units on a scale||Standard Deviation|Mean
832324|NCT01254305|Secondary|Change in Cognitive and Physical Functioning Questionnaire (CPFQ), Last Observation Carried Forward|The Cognitive and Physical Functioning Questionnaire is a patient-rated, 7-item scale used to measure cognitive and executive dysfunction in mood and anxiety disorders. The CPFQ is sensitive to change with treatment and displays convergent validity by significant correlations with other measures of sleepiness, fatigue, apathy, and neuropsychological functioning. Patients are rated on a scale from 1 to 6 for seven common complaints of depressed patients reporting fatigue or cognitive/executive problems—with 1 indicating greater than normal functioning, 2 indicating normal functioning, and 3 to 6 indicating degrees of impaired functioning. The CPFQ ranges from the best possible score of 7 (greater than normal functioning) to the worst possible score of 42 (totally absent).|From Baseline to Week 8|The Randomized Population consisted of 262 patients, with 251 patients who took at least 1 dose of double-blind treatment to comprise the Safety population.||units on a scale||Standard Deviation|Mean
832325|NCT01254305|Primary|Change in Clinical Global Impression of Severity (CGI-S) for Fatigue Score|The CGI-S is a clinician-rated scale that rates the severity of the patient’s current state of fatigue based on the Investigator’s clinical opinion with regard to the patient population with Major Depressive Disorder (MDD). Patient were rated on a scale from 1 to 7, with 1 indicating a normal state and 7 indicating that the patient was among the most extremely fatigued|From Baseline to Week 8|"The Randomized Population consisted of 262 patients, with 251 patients who took at least 1 dose of double-blind treatment to comprise the Safety population.
The Intent-to-Treat (ITT) Population consisted of 248 patients in the Safety Population who had a baseline and at least 1 postbaseline assessment of either the CGI-S or PGI-I fatigue score."||units on a scale||Standard Deviation|Mean
832326|NCT01254318|Secondary|Percentage of Participants With Invasive Fungal Infections in Canada|Data were to be extracted from participant hospital records from 5-9 centers across Canada starting from the time of initiating chemotherapy or conditioning regimen for their stem cell transplant (index date) until one year post-index date, in order to determine the percentage of high risk participants with non-Candida invasive fungal infections.|365 days|Whereas enrollment at 5-9 centers in Canada was planned, this was not accomplished, as data were only collected from a single institution in Canada.|||||
832327|NCT01254318|Secondary|Percentage of Participants With a Specific Fungal Pathogen at a Single Institution|Data were extracted from participant hospital records from the time of initiating chemotherapy or conditioning regimen for their stem cell transplant (index date) until one year post-index date, in order to determine the percentage of participants with a specific fungal pathogen.|365 days|All enrolled participants who received stem cell transplant and high dose chemotherapy for leukemia.||Percentage of participants|||Number
832328|NCT01254318|Primary|Percentage of Participants With Non-Candida Invasive Fungal Infections at a Single Institution|Data were extracted from participant hospital records from the time of initiating chemotherapy or conditioning regimen for their stem cell transplant (index date) until one year post-index date, in order to determine the percentage of high risk participants with non-Candida invasive fungal infections.|365 days|All enrolled participants who received stem-cell transplant and high dose chemotherapy for leukemia.||Percentage of participants||95% Confidence Interval|Number
832329|NCT01254331|Secondary|Number of Participants Who Discontinued Tocilizumab||Week 52|Safety population||participants|||Number
832330|NCT01254331|Primary|Percentage of Participants With Adverse Events (AEs), Serious AEs (SAEs), Related AEs, Discontinuation Due to AEs, or Death||Baseline, every 4 weeks through Week 52|Safety population||percentage of participants|||Number
832332|NCT01254331|Secondary|Mean Erythrocyte Sedimentation Rate (ESR) Levels|ESR is an acute phase reactant and levels of ESR increase with inflammation. ESR is measured as mm/hour.|Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52|Safety population; n=number of participants assessed for the given parameter at the specified timepoint.||mm/hour||95% Confidence Interval|Mean
832333|NCT01254331|Secondary|Mean C-Reactive Protein (CRP) Levels|CRP is an acute phase reactant and levels of CRP increase with inflammation. CRP is measured as milligrams per liter (mg/L).|Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52|Safety population; n=number of participants assessed for the given parameter at the specified timepoint.||mg/L||95% Confidence Interval|Mean
832334|NCT01254331|Secondary|Assessment of Physical Function Using Health Assessment Questionnaire (HAQ)|Physical function was assessed using the HAQ. The HAQ scores range from 0 to 3 with, 0: no assistance needed, 1: participant uses a special device for day-to-day activities, 2: participant usually needs help from another person, and 3: participant uses BOTH a special device AND another person's help for day-to-day activities.|Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52|Safety population; n=number of participants assessed for the given parameter at the specified timepoint.||units on a scale||95% Confidence Interval|Mean
832335|NCT01254331|Secondary|Assessment of Global Disease by the Physician Using Visual Analog Scale (VAS)|"The physician's global assessment of disease activity was assessed using a 0 to 100 mm horizontal VAS by the physician. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). The physician marked the line corresponding to their assessment of disease activity and the distance from the left edge was measured."|Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52|Safety population; n=number of participants assessed for the given parameter at the specified timepoint.||mm||95% Confidence Interval|Mean
832336|NCT01254331|Secondary|Assessment of Global Disease by the Participant Using VAS|"The participant's global assessment of disease activity was assessed using a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). The participants marked the line corresponding to their assessment of disease activity and the distance from the left edge was measured."|Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52|Safety population; n=number of participants assessed for the given parameter at the specified timepoint.||mm||95% Confidence Interval|Mean
832337|NCT01254331|Secondary|Assessment of Pain by the Participant Using Visual Analog Scale (VAS)|"The participants assessed their pain using a 0 to 100 millimeter (mm) horizontal VAS. The left-hand extreme of the line equals 0 mm, and is described as no pain and the right-hand extreme equals 100 mm as unbearable pain. The participants marked the line corresponding to their level of pain and the distance from the left edge was measured."|Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52|Safety population; n=number of participants assessed for the given parameter at the specified timepoint.||mm||95% Confidence Interval|Mean
832338|NCT01254331|Secondary|SJC and TJC|28 joints were assessed for swelling and tenderness. Joints were classified as swollen (1)/not swollen (0) and tender (1)/not tender (0) giving a total possible SJC and TJC score of 0 to 28 each.|Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52|Safety population; n=number of participants assessed for the given parameter at the specified timepoint.||joints||95% Confidence Interval|Mean
832339|NCT01254331|Secondary|Time To Achieve ACR20/ACR50/ACR70|The ACR response rates ACR20/ACR50/ACR70 are defined as ≥20%, ≥50%, or ≥70% improvement, respectively, in SJC and TJC, as well as a ≥20%, ≥50%, or ≥70% improvement, respectively, in 3 of the 5 remaining core ACR assessments: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via (HAQ, and 5) CRP at each visit. The median time to achieve ACR20/ACR50/ACR70 was calculated using Kaplan-Meier estimates.|Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52|Safety population||weeks||Inter-Quartile Range|Median
832340|NCT01254331|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 20 Percent (%), 50% or 70% Improvement (ACR20/ACR50/ACR70)|The ACR response rates ACR20/ACR50/ACR70 are defined as ≥20%, ≥50%, or ≥70% improvement, respectively, in SJC and TJC, as well as a ≥20%, ≥50%, or ≥70% improvement, respectively, in 3 of the 5 remaining core ACR assessments: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a Health Assessment Questionnaire (HAQ), and 5) C-reactive protein (CRP) at each visit.|Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52|Safety population||percentage of participants|||Number
832341|NCT01254331|Secondary|Percentage of Participants Achieving Remission Assessed Using DAS28|DAS28 calculated from the SJC and TJC using the 28 joints count, the ESR (mm/hour) and PtGA of disease activity (VAS) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. Participants were considered in remission when reaching a DAS28 score <2.6.|Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52|Safety population; n=number of participants analyzed at a specific visit||percentage of participants|||Number
832342|NCT01254331|Secondary|Percentage of Participants Achieving LDA Assessed Using DAS28|DAS28 calculated from the SJC and TJC using the 28 joints count, the ESR (mm/hour) and PtGA of disease activity (VAS) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 less than (<) 3.2 = LDA.|Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52|Safety population; n=number of participants analyzed at a specific visit||percentage of participants|||Number
832343|NCT01254331|Secondary|Percentage of Participants Who Achieved Clinically Significant Improvement Assessed Using Disease Activity Score Based on 28 Joints (DAS28)|DAS28 calculated from the swollen joint count (SJC) and tender joint count (TJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and participant's global assessment (PtGA) of disease activity by Visual analog Scale (VAS; participant rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 less than or equal to (≤) 3.2 equals (=) low disease activity (LDA), DAS28 greater than (>) 3.2 to 5.1 = moderate to high disease activity. A reduction of at least 1.2 units in DAS28 was considered clinically significant improvement.|Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52|Safety population; number (n)= number of participants analyzed at a specific visit||percentage of participants|||Number
832344|NCT01254344|Secondary|Percentage of Participants With Favorable Clinical Response|Percentage of participants who have no signs or symptoms of infection at the surgical site and do not require surgical intervention for infection|4 weeks posttreatment|Population analyzed was participants who had no signs or symptoms of infection at the surgical site and did not require surgical intervention for infection.||percentage of participants||95% Confidence Interval|Number
832345|NCT01254344|Primary|Percentage of Participants With Success of Prophylaxis|Percentage of participants who have no signs or symptoms of infection at the surgical site, do not require surgical intervention for infection, and have no need for further antimicrobial therapy|From study drug dose (day of surgery) up to 4 weeks post therapy|"Primary analysis results are for evaluable-patients-only, defined as patients who received a complete dose of prophylaxis, underwent elective colorectal surgery with completion of bowel preparation procedure, had primary skin closure of the wound, and did not receive any prohibited systemic antibiotics or other prohibited anti-infective agents."||percentage of participants||95% Confidence Interval|Number
832346|NCT01254396|Secondary|Plasma Decay Half Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hrs post-dose|Pharmacokinetic parameter analysis population included all randomized and treated participants who had at least 1 of the pharmacokinetic parameters of primary interest in at least 1 treatment period. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.||hrs||Standard Deviation|Mean
832347|NCT01254396|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast).|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hours (hrs) post-dose|Pharmacokinetic parameter analysis population included all randomized and treated participants who had at least 1 of the pharmacokinetic parameters of primary interest in at least 1 treatment period.||ng*hr/mL||Standard Deviation|Geometric Mean
832348|NCT01254396|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hrs post-dose|Pharmacokinetic parameter analysis population included all randomized and treated participants who had at least 1 of the pharmacokinetic parameters of primary interest in at least 1 treatment period. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.||ng*hr/mL||Standard Deviation|Geometric Mean
832349|NCT01254396|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hrs post-dose|Pharmacokinetic parameter analysis population included all randomized and treated participants who had at least 1 of the pharmacokinetic parameters of primary interest in at least 1 treatment period.||hrs||Full Range|Median
832350|NCT01254396|Primary|Maximum Observed Plasma Concentration (Cmax)||0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hrs post-dose|Pharmacokinetic parameter analysis population included all randomized and treated participants who had at least 1 of the pharmacokinetic parameters of primary interest in at least 1 treatment period.||ng/mL||Standard Deviation|Geometric Mean
832351|NCT01254409|Secondary|SGRQ (St. George's Respiratory Questionnaire) Total Score Change From Baseline|St. George's Respiratory Questionnaire Total Score. Scores range from 0 (no impairment) to 100 (maximum impairment). A decrease in score represents a decrease in disease related symptoms. The SGRQ is not validated for IPF.|Day 1 (Baseline) and Day 57|||units on a scale||Standard Deviation|Mean
832352|NCT01254409|Secondary|6MWT (6 Minute Walk Test) Distance Walked Change From Baseline|Change from baseline (measured during screening period) in distance walked during a 6 minute walk test|Screening (between Day -35 and Day 1) and Day 57|||meters||Standard Deviation|Mean
832353|NCT01254409|Secondary|FEV1 (Forced Expiratory Volume 1sec )(%) Change From Baseline||Day 1 (Baseline) and Day 57|||Absolute change in FEV1 % predicted||Standard Deviation|Mean
832354|NCT01254409|Secondary|DLCO (%) (Diffusing Capacity of Carbon Monoxide) Change From Baseline||Day 1 (Baseline) and Day 57|||Absolute change in % predicted DLCO||Standard Deviation|Mean
832355|NCT01254409|Secondary|FVC (Forced Vital Capacity) % Predicted Change From Baseline||Day 1 (Baseline) and Day 57|||absolute change in % predicted FVC||Standard Deviation|Mean
832356|NCT01254409|Secondary|FVC (Forced Vital Capacity) Change From Baseline to Day 57||Change from Day 1 (Baseline) to Day 57|||liters||Standard Deviation|Mean
832357|NCT01254409|Secondary|Vss|Volume of Distribution at Steady State|Day 15|||mL/kg||Full Range|Mean
832358|NCT01254409|Secondary|Total Body Clearance||Day 15|||ml/hr/kg||Full Range|Mean
832359|NCT01254409|Secondary|Terminal Elimination Half Life||Day 15|||hour||Full Range|Mean
832360|NCT01254409|Secondary|AUC48|Area under the curve from 0 to 48 hrs post dose, with samples collected at 0.5, 0.75, 1, 1.5, 2, 3,4,6,8,12,16, 24 and 48 hours post Day 15 dose.|Day 15|||µg*hr/mL||Standard Deviation|Mean
832361|NCT01254409|Secondary|Tmax|Time of Maximum observed concentration|Day 15|||hours||Standard Deviation|Mean
832362|NCT01254409|Secondary|Cmax|Maximum concentration|Day 15|Subjects who received all doses of study treatment||µg/mL||Standard Deviation|Mean
832363|NCT01254409|Primary|Safety and Tolerability|Number of subjects with Dose Limiting Toxicities, Number of Treatment Emergent Serious Adverse Events and Adverse Events|From first dose on Day 1 through Day 57|All subjects who received at least one dose of study treatment||participants|||Number
832364|NCT01254565|Secondary|Percentage of Participants With Mean Phosphorus ≤ 4.5 mg/dL or ≤ 5.5 mg/dL During the Efficacy Assessment Phase||Efficacy assessment phase|Modified intent to treat population||percentage of participants|||Number
832365|NCT01254565|Secondary|Percent Change From Baseline in Corrected Calcium Phosphorus Product (cCa x P) During the Efficacy Assessment Phase|Baseline is defined as the average of pre-hemodialysis values obtained on day -2 and day 1. The efficacy assessment phase (defined as 3 days before and 3 days after the last dose of investigational product) value is the mean of all predialysis values obtained during that period.|Baseline and the efficacy assessment phase (from 3 days before to 3 days after the last dose of study drug; approximately 2 weeks for Cohort 1 and 4 weeks for Cohorts 2 and 3)|Modified intent-to-treat population with available data; Phosphorus data were not collected at baseline for participants in Cohort 1.||percent change||Standard Deviation|Mean
832366|NCT01254565|Secondary|Percent Change From Baseline in Mean Phosphorus (P) During the Efficacy Assessment Phase|Baseline is defined as the average of pre-hemodialysis values obtained on day -2 and day 1. The efficacy assessment phase (defined as 3 days before and 3 days after the last dose of investigational product) value is the mean of all predialysis values obtained during that period.|Baseline and the efficacy assessment phase (from 3 days before to 3 days after the last dose of study drug; approximately 2 weeks for Cohort 1 and 4 weeks for Cohorts 2 and 3)|Modified intent-to-treat population with available data; Phosphorus data were not collected at baseline for participants in Cohort 1.||percent change||Standard Deviation|Mean
832367|NCT01254565|Secondary|Percent Change From Baseline in Mean Corrected Calcium (cCa) During the Efficacy Assessment Phase|Baseline is defined as the average of pre-hemodialysis values obtained on day -2 and day 1. The efficacy assessment phase (defined as 3 days before and 3 days after the last dose of investigational product) value is the mean of all predialysis values obtained during that period.|Baseline and the efficacy assessment phase (from 3 days before to 3 days after the last dose of study drug; approximately 2 weeks for Cohort 1 and 4 weeks for Cohorts 2 and 3)|Modified intent-to-treat population with available data||percent change||Standard Deviation|Mean
832368|NCT01254565|Secondary|Percentage of Participants With Mean Parathyroid Hormone ≤ 300 pg/mL During the Efficacy Assessment Phase|The efficacy assessment phase (defined as 3 days before and 3 days after the last dose of investigational product) value is the mean of all predialysis values obtained during that period.|Efficacy assessment phase (from 3 days before to 3 days after the last dose of study drug; approximately 2 weeks for Cohort 1 and 4 weeks for Cohorts 2 and 3)|Modified intent-to-treat population||percentage of participants|||Number
832369|NCT01254565|Secondary|Percentage of Participants With ≥ 30% Reduction From Baseline in Mean Parathyroid Hormone During the Efficacy Assessment Phase|Baseline is defined as the average of pre-hemodialysis values obtained on day -2 and day 1. The efficacy assessment phase (defined as 3 days before and 3 days after the last dose of investigational product) value is the mean of all predialysis values obtained during that period.|Baseline and the efficacy assessment phase (from 3 days before to 3 days after the last dose of study drug; approximately 2 weeks for Cohort 1 and 4 weeks for Cohorts 2 and 3)|Modified intent-to-treat population||percentage of participants|||Number
832370|NCT01254565|Primary|Percent Change From Baseline in Mean Pre-hemodialysis Parathyroid Hormone (PTH) During the Efficacy Assessment Phase|Baseline is defined as the average of pre-hemodialysis values obtained on day -2 and day 1. The efficacy assessment phase (defined as 3 days before and 3 days after the last dose of investigational product) value is the mean of all predialysis values obtained during that period.|Baseline and the efficacy assessment phase (EAP; defined as the period between 3 days before and 3 days after the last dose of study drug; approximately 2 weeks for Cohort 1 and 4 weeks for Cohorts 2 and 3)|Modified intent-to-treat population||percent change||Standard Deviation|Mean
832371|NCT01254604|Primary|Number of Participants Who Discontinued Study Drug Due to an AE|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Participants who discontinued study drug treatment due to an AE are counted once in this summary.|Up to Week 4|APaT population||participants|||Number
832372|NCT01254604|Primary|Number of Participants With an Adverse Event (AE)|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Participants with one or more AEs during the study are counted once in this summary.|Up to 14 days after Week 4 visit|APaT population||participants|||Number
832373|NCT01254604|Secondary|Number of Participants With ≥25% Reduction in IOP From Baseline to Week 4 - Study Eye|IOP was measured at baseline, Week 2 and Week 4 using a Goldmann applanation tonometer. At each of these visits, IOP measurement was performed at 0800, 1000 and 1600 hours. At each IOP assessment time point during a visit, 2 consecutive IOP measurements were made. If these 2 measurements differed by ≤2 mmHg, then the average of the 2 IOP values was recorded. If the 2 measurements differed by >2 mmHg, then a third measurement was obtained and the median of these 3 measurements was recorded. The IOP value for a visit (e.g., Week 4) was the mean of the values recorded at the 3 time points during the visit. For each participant, one “study eye” was identified for data summarization and analysis. The “study eye” was the eye with the higher (i.e., “worse”) IOP at baseline, or if both eyes had the same baseline IOP value, the right eye was designated the “study eye.” Percent reduction in IOP at Week 4 = ([baseline IOP value − Week 4 IOP value]/Baseline IOP value)*100.|Baseline and Week 4|Per Protocol population: Participants who received at least one dose of study drug, had at least one efficacy measurement available for an analysis endpoint and did not have any protocol violations that may substantially affect the results of the primary efficacy endpoint||participants|||Number
832374|NCT01254604|Primary|Mean Diurnal IOP Change From Baseline at Week 4 - Study Eye|IOP was measured at baseline, Week 2 and Week 4 using a Goldmann applanation tonometer. At each of these visits, IOP measurement was performed at 0800, 1000 and 1600 hours. At each IOP assessment time point during a visit, 2 consecutive IOP measurements were made. If these 2 measurements differed by ≤2 mmHg, then the average of the 2 IOP values was recorded. If the 2 measurements differed by >2 mmHg, then a third measurement was obtained and the median of these 3 measurements was recorded. The IOP value for a visit (e.g., Week 4) was the mean of the values recorded at the 3 time points during the visit. For each participant, one “study eye” was identified for data summarization and analysis for this primary efficacy outcome measure. The “study eye” was the eye with the higher (i.e., “worse”) IOP at baseline, or if both eyes had the same baseline IOP value, the right eye was designated the “study eye.” Change from baseline in IOP at Week 4 = Week 4 IOP value − baseline IOP value.|Baseline and Week 4|Per Protocol population: Participants who received at least one dose of study drug, had at least one efficacy measurement available for an analysis endpoint and did not have any protocol violations that may substantially affect the results of the primary efficacy endpoint||mmHg||95% Confidence Interval|Least Squares Mean
832384|NCT01254656|Secondary|Change From Baseline in CD4+ Lymphocyte Counts (Absolute) at 144 Weeks From Day 1 of the Parent Protocol|Participant's immunological status assessed by CD4+ lymphocyte count (absolute and percentage) at 48 weeks (ie, 144 weeks from Day 1 of the parent protocol)|144 Weeks from Day 1 of the parent protocol|All participants enrolled in this protocol constituted the analysis population associated with each of the parent protocols and all available data were used for efficacy analyses. Last observation carried forward (LOCF) was used to impute missing values.||cells/uL||Standard Deviation|Mean
832375|NCT01254643|Secondary|Geometric Mean Titers (GMTs) for Each of the HPV Types Contained in the Vaccine|Serum antibody titers for HPV virus-like particles (VLPs), Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using cLIA. Titers are reported in milli Merck Units/mL.|4 weeks post-vaccination 3 (Month 7)|Participants who received all 3 vaccinations and met criteria for Per Protocol Immunogenicity (PPI) Population (not a general protocol violator, received all vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), and had a Month 7 serum sample collected within an acceptable day range) for at least 1 of the 9 HPV types.||milli Merck units/mL||95% Confidence Interval|Geometric Mean
832376|NCT01254643|Primary|Percentage of Participants With a Vaccine-related AE|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Adverse experience that is judged by the Investigator to be “definitely related,” “probably related,” or “possibly related” to the study drug is defined as a vaccine-related AE.|up to 15 days after any vaccination|Safety Population, which consists of all participants who received at least one vaccination and had available follow-up data.||Percentage of Participants|||Number
832377|NCT01254643|Primary|Percentage of Participants With a Non-Injection Site (Systemic) AE|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Systemic AEs were those not categorized as injection-site AEs.|up to 15 days after any vaccination|Safety Population, which consisted of all participants who received at least one vaccination and had available follow-up data.||Percentage of Participants|||Number
832378|NCT01254643|Primary|Percentage of Participants With an Injection-site Adverse Event (AE)|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. AEs such as redness, swelling, and pain/tenderness/soreness at the injection site were recorded.|up to 5 days after any vaccination|Safety Population, which consisted of all participants who received at least one vaccination and had available follow-up data.||Percentage of Participants|||Number
832379|NCT01254643|Primary|Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine|Serum antibody titers for HPV virus-like particles (VLPs), Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using competitive luminex immunoassay (cLIA). The serostatus cutoffs (milli Merck U/mL) for HPV types were as follows: HPV Type 6: ≥30, HPV Type 11: ≥16; HPV Type 16: ≥20, HPV Type 18: ≥24, HPV Type 31: ≥10, HPV Type 33: ≥8, HPV Type 45: ≥8, HPV Type 52: ≥8, and HPV Type 58: ≥8.|4 weeks post-vaccination 3 (Month 7)|Participants who received all 3 vaccinations and met criteria for Per Protocol Immunogenicity (PPI) Population (not a general protocol violator, received all vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), and had a Month 7 serum sample collected within an acceptable day range) for at least 1 of the 9 HPV types.||Percentage of Participants||95% Confidence Interval|Number
832380|NCT01254656|Secondary|Virology Analysis Participant Accountability From Week 96 Through Study Termination|Virology analysis included virus susceptibility (phenotype and genotype)to a standard panel of approved antiretrovirals as determined by the Monogram Biosciences PhenoSense GT assay. Below analysis table included the following parameters: 1. “protocol-defined treatment failure” was defined as an increase in HIV-1 RNA to detectable levels (≥50 copies/mL) on 2 consecutive measurements, the second measurement taken no more than 14 days after the first measurement); 2. “Treatment failure”: treatment failure (both virologic and non-virologic) was defined as a subject who met the protocol-defined treatment failure criterion or discontinued from the study; 3. “NRTI or NNRTI resistance mutations”: nucleoside reverse transcriptase inhibitor or lersivirine-associated resistance-associated mutations (RAM) based on the International AIDS Society–USA (IAS-USA) RAM guidelines; 4. ‘with result’ meant an analyzed sample returned genotypic result or phenotypic result or both.|Week 96 through study termination|The virology analysis set included only evaluable participants i.e. those having samples with valid genotypic or phenotypic susceptibility testing results and HIV-1 RNA >500 copies/mL. However, samples with observed emergence of resistance-associated mutations and HIV-1 RNA level ≤500 copies/mL or missing HIV-1 RNA level, were also noted.||Participants|||Number
832381|NCT01254656|Secondary|Change From Baseline in CD4+ Lymphocyte Counts (Percentage) at 192 Weeks From Day 1 of the Parent Protocol|Participant's immunological status assessed by CD4+ lymphocyte count (absolute and percentage) at 192 weeks from Day 1 of the parent protocol.|192 Weeks from Day 1 of the parent protocol|Analyses included all enrolled participants. Week 192 data are presented as Week 208 had few participants. For participants who discontinued prematurely, LOCF was used to impute values for post discontinuation visits. Participants who discontinued due to termination of the program were not included in the analysis for the post termination visits.||Percentage||Standard Deviation|Mean
832382|NCT01254656|Secondary|Change From Baseline in CD4+ Lymphocyte Counts (Absolute) at 192 Weeks From Day 1 of the Parent Protocol|Participant's immunological status assessed by CD4+ lymphocyte count (absolute and percentage) at 192 weeks from Day 1 of the parent protocol.|192 Weeks from Day 1 of the parent protocol|Analyses included all enrolled participants. Week 192 data are presented, as Week 208 had few participants. For participants who discontinued prematurely, LOCF was used to impute values for post discontinuation visits. Participants who discontinued due to termination of the program were not included in the analysis for the post termination visits.||cells/uL||Standard Deviation|Mean
832383|NCT01254656|Secondary|Change From Baseline in CD4+ Lymphocyte Counts (Percentage) at 144 Weeks From Day 1 of the Parent Protocol|Participant's immunological status assessed by CD4+ lymphocyte count (absolute and percentage) at 48 weeks (ie, 144 weeks from Day 1 of the parent protocol)|144 Weeks from Day 1 of the parent protocol|All participants enrolled in this protocol constituted the analysis population associated with each of the parent protocols and all available data were used for efficacy analyses. LOCF was used to impute missing values.||Percentage||Standard Deviation|Mean
832413|NCT01255423|Secondary|Onset of Pain Relief|Onset of perceptible pain relief|Day 1|||Hour||Inter-Quartile Range|Median
832385|NCT01254656|Secondary|Number of Participants With Plasma HIV‑1 RNA Level <50 Copies/mL up to Week 208|Number of participants with HIV-1 RNA level <50 copies/mL plasma was summarized at last visit. Abbott RealTime HIV-1 assay was used to measure the HIV-1 RNA level.|Up to Week 208|Analyses included all enrolled participants. Last visit used the last available visit of each participant. Discontinued from study, lost to follow-up, or missing HIV-1 RNA level data at last visit were considered to have HIV-1 RNA levels >=50 copies/mL. Participants discontinued due to program termination were not considered as discontinuations.||Participants|||Number
832386|NCT01254656|Primary|Number of Participants With Plasma Human Immunodeficiency Virus - 1 (HIV‑1) Ribonucleic Acid (RNA) Level <50 Copies/mL at 144 Weeks From Day 1 of the Parent Protocol|Number of participants with HIV-1 RNA level <50 copies/mL plasma was summarized at 48 weeks i.e. 144 weeks from Day 1 of the parent protocol. Roche Amplicor HIV-1 Monitor assay was used to measure the HIV-1 RNA level.|144 Weeks from Day 1 of the parent protocol|All participants enrolled in this protocol constituted the analysis population associated with each of the parent protocols and all available data were used for efficacy analyses.||Participants|||Number
832387|NCT01254669|Secondary|The Secondary Outcome Will be Maternal Knowledge About HPV Vaccine.|post-educational intervention assessment of HPV knowledge ranges from 0 (minimal knowledge) to 12 (maximal knowledge)|1 hour after intervention|The number of participants for analysis was determined based on the total enrolled and who responded to knowledge questions||units on a scale||Standard Deviation|Mean
832388|NCT01254669|Primary|The Receipt of the First HPV Vaccination|Receipt of the first HPV vaccination among adolescent daughters of the participants|within 1 month of randomization|The number of participants for analysis was determined based on number of participants enrolled and who answered questions of interest.||percentage of participants|||Number
832389|NCT01254721|Primary|The Changes From Baseline in Young Mania Rating Scale (YMRS) Total Score to Day 29|The Young Mania Rating Scale (YMRS) is an eleven-item, multiple-choice diagnostic questionnaire which psychiatrists use to measure the severity of manic episodes. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. These four items are given twice the weight of the others to compensate for poor cooperation from severely ill patients. Total score is summed of 11items. Total score rage is from 0 to 60 and the higher score represent a worse oucome.|From Baseline to Day 29|||scores on the scale||Standard Deviation|Mean
832390|NCT01254721|Secondary|The Change From Baseline up to Day 29 and Final Assessment in the Clinical Global Impression-Severity of Illness Scale (CGI-S)|The Severity of Illness scale (CGI-S) is scored to rate the patient’s current clinical state. The score range is form 0 to 7. A CGI-S score of 1 indicates that a patient is “Normal, not at all ill” and a score of 7 indicates that a patient is “Among the most extremely ill patients”.|From Baseline to Day 29|||scores on the scale||Standard Deviation|Mean
832391|NCT01254747|Secondary|Overall Satisfaction|Overall satisfaction was recorded on a 5-point Likert scale as a single, retrospective evaluation of 4 weeks of wear. The following scale was used: 2=very satisfied, 1=somewhat satisfied, 0=neither, -1=somewhat dissatisfied, and -2=very dissatisfied.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Units on a scale||Standard Deviation|Mean
832392|NCT01254747|Secondary|Corrected Visual Acuity|Corrected visual acuity was tested for each eye while the participant read distant charts in normal lighting. Corrected visual acuity was measured with a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal distance eyesight. Positive logMAR values indicate poorer vision, and negative values denote better visual acuity.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.||logMAR|Participants|Standard Deviation|Mean
832393|NCT01254747|Secondary|Lens Fit|Lens fit was assessed by the investigator for each eye using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit was graded on a 5-point scale, with 2=unacceptable loose, 1=acceptable loose, 0=optimal, -1=acceptable tight, and -2=unacceptable tight.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Units on a scale|Participants|Standard Deviation|Mean
832394|NCT01254747|Primary|Average Daily Wear Time|Average daily wear time (hours) was reported by the participant as a single, retrospective evaluation of 4 weeks of wear.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Hours||Standard Deviation|Mean
832395|NCT01254747|Primary|Dryness Throughout the Day|Dryness throughout the day was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Dryness throughout the day was measured on a 10-point scale, with 1 being very dry and 10 being not dry.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Units on a scale||Standard Deviation|Mean
832396|NCT01254747|Primary|Overall Handling|Overall handling was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall handling was measured on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Units on a scale||Standard Deviation|Mean
832397|NCT01254747|Primary|Vision Quality During the Day|Vision quality during the day was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Vision quality during the day was measured on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Units on a scale||Standard Deviation|Mean
832398|NCT01254747|Primary|Overall Comfort|Overall comfort was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Units on a scale||Standard Deviation|Mean
832399|NCT01254760|Secondary|Overall Fit|Overall lens fit was assessed by the investigator at study visit using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit was assessed by eye and graded on a 5-point scale, with 2=unacceptably loose, 1= acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight|Day 5, lenses replaced daily|Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Units on a Scale|Participants|Standard Deviation|Mean
832400|NCT01254760|Primary|Overall Vision|Overall vision was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. Overall vision was measured on a 10-point scale, with 1 being poor and 10 being excellent.|5 days of wear, lenses replaced daily|Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Units on a Scale||Standard Deviation|Mean
832401|NCT01254760|Primary|Handling at Removal|Handling at removal was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. Handling at removal was measured on a 10-point scale, with 1 being poor/difficult and 10 being excellent/easy.|5 days of wear, lenses replaced daily|Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Units on a Scale||Standard Deviation|Mean
832402|NCT01254760|Primary|End of Day Dryness|End of day dryness was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. End of day dryness was measured on a 10-point scale, with 1 being very dry and 10 being not dry.|5 days of wear, lenses replaced daily|Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Units on a Scale||Standard Deviation|Mean
832403|NCT01254760|Primary|End of Day Comfort|End of day comfort was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. End of day comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent.|5 days of wear, lenses replaced daily|Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Units on a scale||Standard Deviation|Mean
832404|NCT01254851|Primary|Number of Steps Taken in 24 Hours.|The primary outcome assessed was the number of steps taken in the 24 hour period prior to discharge as assessed by the electronic pedometer readings.|1 day|The analysis is an intention to treat (ITT) analysis comprising all participants who were randomized.||Steps||Full Range|Median
832405|NCT01254890|Secondary|Phase II: Number of Participants With Response|Response according to International Working Group response criteria for Acute myeloid leukemia (AML) (JCO 2003; 21: 4642-9): CR defined by presence of <5% blasts in the bone marrow (BM), with >1 X 10^9/L neutrophils and >100 x 10^9/L platelets in the peripheral blood (PB) with no detectable extramedullary disease. Participants who met the above criteria but had neutrophil or platelet counts less than the stated values were considered to have achieved CRi (CR with incomplete recovery of PB counts) or CR with incomplete platelet recovery (CRp) if CR but platelets < 100 x 10^9/L but ≥ 50 x 10^9/L and platelet transfusion independent. Partial response (PR) required all of the hematologic values for a CR but with a decrease of >/= 50% in the percentage of blasts to 5% to 25% in the BM aspirate.|90 days|Nine participants were not evaluable for response.||participants|||Number
832406|NCT01254890|Primary|Phase I: Maximum Tolerated Dose (MTD) of Sorafenib Given With Azacitidine|MTD is defined as highest dose level in which 6 patients treated with at most 1 experiencing a dose limiting toxicity (DLT) during 1st cycle. One cycle of therapy is 7 days of azacitidine (AZA) and 28 days of sorafenib. Starting dose of Sorafenib is 200 mg twice a day azacitidine|28 day cycle|||mg/twice daily|||Number
832407|NCT01255137|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse events module.|3/2/11 - 8/2/12|||Participants|||Number
832408|NCT01255137|Primary|Response Rate (RR) of Axitinib Administered Daily, in Patients With Recurrent, Metastatic, or Primary Unresectable Adrenocortical Cancer (ACC)|Response was defined by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is a disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10mm. Partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameter. Progressive disease (PD) is a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm (Note: the appearance of one or more new lesions is also considered progression). Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking s reference the smallest sum diameters while on study.|2 years|||Participants|||Number
832409|NCT01255306|Secondary|Retinal Nerve Fiber Layer Thickness Change in Patients With Raised Intraocular Pressure Secondary to Silicone Oil Endotamponade|To assess whether retinal nerve fiber layer thickness changes in patients with raised intraocular pressure secondary to silicone oil endotamponade.|6 months|We included all patients who completed follow up visits and who had valid OCT measurements as defined per protocol.||micrometer|Participants|Standard Deviation|Mean
832410|NCT01255306|Primary|Evidence of Retinal Nerve Fibre Layer Thickness Change Measured by Optical Coherence Tomography|Retinal nerve fiber layer thickness change measured by optical coherence tomography might be an additional parameter that could provide new insights into clinical decision making in patients with silicone oil tamponade.|6 months|We included all patients that have completed necessary follow up visits and have had optical coherence tomography measurements at all visits in the final analysis.||micrometer|Participants|Standard Deviation|Mean
832411|NCT01255423|Secondary|Ankle Joint Function|"Ankle joint function score (Karlsson Scoring scale which ranges from 0 worst possible score to 90 best possible score)at 24 and 72 hours and 7 days."|24 and 72 hours, 7 days|||Total score||Standard Deviation|Mean
832412|NCT01255423|Secondary|Tenderness|Tenderness at 24 and 72 hours and 7 days. Change from baseline. Tenderness was measured by a calibrated algometer in order to quantify the pressure pain threshold, a measure of tenderness.|Change from baseline at 24 and 72 hours, 7 days|||N/cm^2||Standard Deviation|Mean
832416|NCT01255436|Secondary|Percentage of Patients With Controlled Blood Pressure at the End of 12 Weeks|The percentage of patients with systolic blood pressure less than 140 mmHg and diastolic blood pressure less than 90 mmHg at the end of 12 weeks|12 weeks|Only patients who completed follow up and had evaluable data were analyzed.||percentage of participants|||Number
832417|NCT01255436|Secondary|Medication Adherence Rate|The percentage of patients with an improvement of at least one point in adherence score as measured by the Adherence Self-Report Questionnaire at the end of 12 weeks Scale Range: 1 to 6, with 1 being the highest (most adherent) and 6 being the lowest (least adherent)|12 weeks|Only patients who completed follow up and had evaluable data were analyzed.||percentage of participants|||Number
832418|NCT01255436|Primary|Mean Absolute Change in Diastolic Blood Pressure After 12 Weeks|Absolute change in diastolic blood pressure from baseline to 12 weeks|baseline and 12 weeks|Only patients who completed follow up and had evaluable data were analyzed.||mmHg||Standard Deviation|Mean
832419|NCT01255436|Primary|Mean Absolute Change in Systolic Blood Pressure After 12 Weeks|Absolute change in systolic blood pressure from baseline to 12 weeks|baseline and 12 weeks|Only participants who completed follow up and had evaluable data were analyzed.||mmHg||Standard Deviation|Mean
832420|NCT01255449|Secondary|Post-HSCT Changes in Lung Tissue Density|Changes in lung tissue density were measured by quantitative computed tomography(CT) scan 2 weeks before and 2 months after HSCT|Before and 2 months after HSCT|CT scans, in a format suitable for software analysis, were available in 8 patients only||g/mL||Standard Deviation|Mean
832421|NCT01255449|Primary|Airway Distensibility With Lung Inflation After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)|We studied 26 subjects, 2 weeks before and 2 months after HSCT. Within-breath respiratory system conductance (Grs) at 5, 11 and 19 Hz was measured by forced oscillation technique (FOT) at functional residual capacity (FRC) and total lung capacity (TLC)|2 weeks before and 2 months after HSCT|||1/cmH2O*s||Standard Deviation|Mean
832422|NCT01255592|Secondary|Ratio of Interleukin-8 (IL-8) in Serum at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).||ratio||90% Confidence Interval|Least Squares Mean
832423|NCT01255592|Secondary|Ratio of Interleukin-1 Beta (IL-1β) in Serum at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).||ratio||90% Confidence Interval|Least Squares Mean
832424|NCT01255592|Secondary|Ratio of Interleukin-6 (IL-6) in Serum at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).||ratio||90% Confidence Interval|Least Squares Mean
832425|NCT01255592|Secondary|Ratio of Growth-related Oncogene-α (GRO-α) in Serum at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).||ratio||90% Confidence Interval|Least Squares Mean
832426|NCT01255592|Secondary|Ratio of Tumor Necrosis Factor Alpha (TNF-α) in Serum at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).||ratio||90% Confidence Interval|Least Squares Mean
832427|NCT01255592|Secondary|Ratio of C-reactive Protein (CRP) in Serum at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).||ratio||90% Confidence Interval|Least Squares Mean
832428|NCT01255592|Secondary|Ratio of Serum Amyloid A (SAA) in Serum at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).||ratio||90% Confidence Interval|Least Squares Mean
832429|NCT01255592|Secondary|Ratio of Neutrophil Elastase Activity in Sputum at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).||ratio||90% Confidence Interval|Least Squares Mean
832430|NCT01255592|Secondary|Ratio of Interleukin-8 (IL-8) in Sputum at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).||ratio||90% Confidence Interval|Least Squares Mean
832431|NCT01255592|Secondary|Ratio of Growth-related Oncogene-α (GRO-α) in Sputum at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).||ratio||90% Confidence Interval|Least Squares Mean
832432|NCT01255592|Secondary|Ratio of Tumor Necrosis Factor Alpha (TNF-α) in Sputum at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).||ratio||90% Confidence Interval|Least Squares Mean
832433|NCT01255592|Secondary|Ratio of Monocyte Chemoattractant Protein-1 (MCP-1) in Sputum at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).||ratio||90% Confidence Interval|Least Squares Mean
832434|NCT01255592|Secondary|Ratio of Regulated on Activation, Normal T Cell Expressed and Secreted (RANTES) in Sputum at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).||ratio||90% Confidence Interval|Least Squares Mean
832435|NCT01255592|Secondary|Ratio of Interleukin-6 (IL-6) in Sputum at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).||ratio||90% Confidence Interval|Least Squares Mean
832436|NCT01255592|Secondary|Ratio of Interleukin-1 Beta (IL-1β) in Sputum at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).||ratio||90% Confidence Interval|Least Squares Mean
832437|NCT01255592|Secondary|Change From Baseline Total and Domain Scores in St. George’s Respiratory Questionnaire for COPD Patients (SGRQ-C)|"SGRQ-C total score shows the impact of COPD on patient's health status, and expressed as a percentage of impairment with scale from 0 (best health status) to 100 (worst possible status). The SGRQ-C contains 3 domains:
Symptom (distress due to respiratory symptoms), Activity (disturbance of physical activity) and Impact (overall impact on daily life and well being). All three domains with scale from 0 (best health status) to 100 (worst possible status)."|Baseline and end of treatment (Day 28)|The efficacy analysis set included all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.||units on a scale||Standard Error|Least Squares Mean
832438|NCT01255592|Secondary|Change From Baseline for the Symptom Scores of the Bronkotest Diary Card|The Bronkotest diary card is a paper based diary card that was filled out by patients daily, recording values from morning and evening peak expiratory flow (PEF) measurements and answering 8 questions on signs and symptoms. Symptom scores were recorded for night-time symptoms, breathing, sputum colour, sputum amount, sputum type, wellbeing, number of puffs of inhalers, and cough, generally scored on a scale from 0 (no symptoms) to 4 (worst symptoms). Summary statistics for baseline (mean of the last 7 days prior to first dose) and change (mean of the last 7 days on treatment - baseline) only contain patients included in the analysis. For symptom scores a decrease is an improvement, for PEF an increase is an improvement.|Baseline and Last 7 days on treatment|The efficacy analysis set included all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.||units on a scale||Standard Error|Least Squares Mean
832449|NCT01255631|Secondary|Lymphedema|No participants were assessed for this secondary outcome measure: lymphedema. No data was collected/calculated, and hence the data cannot be summarized to include in the data tables. No meaningful quantifiable data could be obtained on degree of lymphedema, and thus effect of PEMF intervention could not be analyzed.|Pre- and Post-Operative Period|No participants were assessed for this secondary outcome measure: lymphedema. No data was collected/calculated, and hence the data cannot be summarized to include in the data tables. No meaningful quantifiable data could be obtained on degree of lymphedema, and thus effect of PEMF intervention could not be analyzed.|||||
832439|NCT01255592|Secondary|Change From Baseline for the Morning PEF and Evening PEF of the Bronkotest Diary Card|The Bronkotest diary card is a paper based diary card that was filled out by patients daily, recording values from morning and evening peak expiratory flow (PEF) measurements and answering 8 questions on signs and symptoms. Summary statistics for baseline (mean of the last 7 days prior to first dose) and change (mean of the last 7 days on treatment - baseline) only contain patients included in the analysis. For symptom scores a decrease is an improvement, for PEF an increase is an improvement.|Baseline and Last 7 days on treatment|The efficacy analysis set included all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.||L/min||Standard Error|Least Squares Mean
832440|NCT01255592|Secondary|Transition Dyspnea Index (TDI) at End of Treatment (Day 28)|TDI measures changes in dyspnea severity from the baseline as established by the Baseline Dyspnea Index (BDI). TDI is an interviewer-administered rating of severity of dyspnea that assesses Change in Functional Impairment, Change in Magnitude of Task, and Change in Magnitude of Effort domains on a 7-point scale ranging from -3 (major deterioration) to +3 (major improvement). Total score ranges from -9 to +9. The lower the score, the more deterioration in severity of dyspnea.|Baseline to end of treatment (Day 28)|The efficacy analysis set included all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.||units on a scale||Standard Error|Least Squares Mean
832441|NCT01255592|Secondary|Change From Baseline in Forced Expiratory Flow Between 25% and 75% of Forced Vital Capacity (FEF25-75)|Lung function tests consisted of 3 forced expiratory maneuvers in which the patient expired forcefully from total lung capacity to residual volume, recorded using a spirometer. FEF25-75 is flow rate during the middle half of forced vital capacity (25%-75% of the total volume (FVC) exhaled).|Baseline to end of treatment (Day 28)|The efficacy analysis set included all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.||liters/second||Standard Error|Least Squares Mean
832442|NCT01255592|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)|Lung function tests consisted of 3 forced expiratory maneuvers in which the patient expired forcefully from total lung capacity to residual volume, recorded using a spirometer. FEV1 is the volume expired in the first second of maximal expiration after a full inspiration.|Baseline to end of treatment (Day 28)|The efficacy analysis set included all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.||liters||Standard Error|Least Squares Mean
832443|NCT01255592|Secondary|Change From Baseline in Forced Vital Capacity (FVC)|Lung function tests consisted of 3 forced expiratory maneuvers in which the patient expired forcefully from total lung capacity to residual volume, recorded using a spirometer. FVC is the maximum volume of air which can be exhaled or inspired during a forced maneuver.|Baseline to end of treatment (Day 28)|The efficacy analysis set included all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.||liters||Standard Error|Least Squares Mean
832444|NCT01255592|Secondary|Change From Baseline in Slow Vital Capacity (SVC)|Lung function tests consisted of 3 forced expiratory maneuvers in which the patient expired forcefully from total lung capacity to residual volume, recorded using a spirometer. SVC is the measure of the change in volume of gas in the lungs from complete inspiration to complete expiration.|Baseline to end of treatment (Day 28)|The efficacy analysis set included all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.||liters||Standard Error|Least Squares Mean
832445|NCT01255592|Secondary|Change From Baseline in Weight of 24-hour Sputum Collection|Patients collected all sputum produced during a 24-hour period at baseline and Day 28.|Baseline and end of treatment (Day 28)|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).||grams||Standard Error|Least Squares Mean
832446|NCT01255592|Secondary|Ratio of the Percentage Neutrophil Cell Count in Sputum at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).||ratio||90% Confidence Interval|Least Squares Mean
832447|NCT01255592|Primary|Ratio of Absolute Neutrophil Cell Count in Sputum at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).||ratio||90% Confidence Interval|Least Squares Mean
832448|NCT01255631|Secondary|Narcotic Pain Medications|No participants were assessed for this secondary outcome measure: narcotic pain medications. No data was collected/calculated, and hence the data cannot be summarized to include in the data tables. Patients were instructed to complete logs at home indicating narcotic pain medications, and patients did not submit necessary logs assessing need for pain medications and level of nausea and vomiting; therefore, no meaningful data could be analyzed.|Post-Operative Period|No participants were assessed for this secondary outcome measure: narcotic pain medications. No data was collected/calculated, and hence the data cannot be summarized to include in the data tables. Patients were instructed to complete logs at home indicating narcotic pain medications, and patients did not submit necessary logs.|||||
832450|NCT01255631|Secondary|Clinical Assessment of Shoulder and Arm Symptoms Before and After PEMF|No participants were assessed for this secondary outcome measure: clinical assessment of shoulder and arm symptoms before and after PEMF. No data was collected/calculated, and hence the data cannot be summarized to include in the data tables. There was a lack of post-clinical assessment data as well as poor patient compliance with the 14 day mark follow up. Therefore, no meaningful results could be derived since there was no quantifiable means to compare before and after PEMF data points.|Pre- and Post-Operative Period|No participants were assessed for this secondary outcome measure: clinical assessment of shoulder and arm symptoms before and after PEMF. No data was collected/calculated, and hence the data cannot be summarized to include in the data tables due to lack of post-clinical assessment data and poor patient compliance with the 14 day mark follow up.|||||
832451|NCT01255631|Secondary|Patient Self-Assessment of Shoulder and Arm Symptoms Before and After PEMF|No participants were assessed for this secondary outcome measure: patient self-assessment of shoulder and arm symptoms before and after PEMF. No data was collected/calculated, and hence the data cannot be summarized to include in the data tables. Patients did not complete the necessary surveys assessing their shoulder and arm symptoms; therefore, no meaningful results could be derived since there were no surveys to compare before and after PEMF data points.|Pre- and Post-Operative Period|No participants were assessed for this secondary outcome measure: patient self-assessment of shoulder and arm symptoms before and after PEMF. No data was collected/calculated, and hence the data cannot be summarized to include in the data tables. Patients did not complete the necessary surveys assessing their shoulder and arm symptoms.|||||
832452|NCT01255631|Secondary|Jackson Pratt (JP) Drain Output|Total volume (in units of millimeters - mL) of Jackson Pratt (JP) drain output on post-operative day 1 and day 2 were recorded for patients in the study.|Post-Operative Day 1 & 2 (2 Days)|For the 7 patients who completed the study, the mean and standard deviations for the total JP drain output (in milliliters - mL) from post-operative days 1 & 2 (2 days total) were analyzed as a secondary outcome.||milliliters (mL)||Standard Deviation|Mean
832453|NCT01255631|Primary|Pain Level on Visual Analog Scale|Pain will be the primary outcome measured by patient level of pain as quantified by a visual analog scale with written descriptions, and amount of pain medication used hourly until the patient is discharged (up to a maximum of six hours post-op), then daily for a total of two weeks post-op. The VAS pain scale ranges from 0 (no pain) to 10 (worst possible pain).|2 weeks|Only 7 patients completed the study by quantifying the level of their pain post-operatively on a visual analog scale from 0-10. The medication logs and two week post-op analogs could not be utilized for the analysis since all 7 patients did not complete these logs.||units on a scale||Standard Deviation|Mean
832454|NCT01255722|Secondary|Average Contrast-to-noise Ratio (Average CNR)|"Signal attenuation was measured by off-site radiologists in the lumen of 4 coronary segments in the ascending aorta and the in left ventricle and expressed in Hounsfield Unit (HU).
A measure of noise in CT scans was collected at least in the aorta and if possible in the muscle and/or air.
In territories where pre and post signal attenuation measures were both available, the contrast-to-noise ratio was computed according to the following formula: CNR = (Post Att – Baseline Att) / Image Noise"|<1h|Full Analysis Set: included all patients who underwent the examination and had available assessments of the primary endpoint.||Hounsfield Units:Hounsfield Units||Standard Deviation|Mean
832455|NCT01255722|Secondary|Average Signal-to-Noise Ratio (Average SNR)|"Signal attenuation was measured by off-site radiologists in the lumen of 4 coronary segments, in the ascending aorta and in the left ventricle and was expressed in Hounsfield Unit (HU). Measurements were set in post-injection images for the 6 territories.
A measure of noise in CT scans was collected at least in the aorta and if possible in the muscle and/or air.
Signal-to-Noise Ratios (SNR) of post-injection images were derived in all territories from attenuation measurements according to the following formula:
SNR Territory = Post Attenuation / Image Noise"|<1h|Full Analysis Set: included all patients who underwent the examination and had available assessments of the primary endpoint.||Hounsfield Units:Hounsfield Units||Standard Deviation|Mean
832456|NCT01255722|Secondary|Average Signal Attenuation After IV Injection of Contrast|Attenuation of signal was measured off-site on post-injection images of four coronary segments, in the ascending aorta and in the left ventricle, then it was averaged at the patient level.|<1h|Full Analysis Set: all patients who underwent the coronary CT scan examination and had available assessments of the primary endpoint.||Hounsfield Units||Standard Deviation|Geometric Mean
832457|NCT01255722|Secondary|Coronary Track Rate|A post processing software automatically tracked the number of distal segments of the left anterior descending coronary artery, the left circumflex coronary artery and the right coronary artery . The number of segments tracked per patient were assessed by an independent off-site radiologist.|<24h|Full Analysis Set population: all patients who underwent the coronary CT scan examination and had available assessments of the primary endpoint.||Number of tracked segments per patient||Standard Deviation|Mean
832458|NCT01255722|Secondary|Average Image Quality According to Off-site Reading|For each patient, all 18 coronary segments were graded for image quality using a 5-point evaluation scale (from 0=non-diagnostic to 4=excellent). The average image quality was evaluated using the off-site readings, by averaging the scores obtained for the 18 segments used to determine the CT evaluability (primary criteria).|<24h|Full Analysis Set: all patients who underwent the coronary CT scan examination and had available assessments of the primary endpoint.||Image quality Score on a scale||Standard Deviation|Mean
832459|NCT01255722|Primary|Rate of Patients With Evaluable CT Scans i.e. Allowing Identification of Coronary Artery Stenosis According to Off-site Reading Assessment|"Evaluability was based upon the off-site assessment of 18-coronary segments graded for image quality with a 5-point scale.4= Excellent quality, fully confidence without any doubts concerning the presence/absence of luminal stenosis; 3= Good quality, confidence concerning the presence/absence of luminal stenosis; 2= Moderate quality, relative confidence, with minor doubts concerning the presence/absence of luminal stenosis; 1= Poor quality, some doubts concerning the presence/absence of stenosis; 0= Non diagnostic.
A patient’s CT scan was considered as evaluable for identification of coronary artery stenosis if none of the 18 coronary segments had a score of 0."|< 24h|Full Analysis Set: all patients who underwent the coronary CT scan examination and had available assessments of the primary endpoint.||Percentage of patients||Standard Error|Geometric Mean
832508|NCT01256008|Secondary|Visual Analogue Scale (VAS)|"The scale is used to assess the pain intensity of patients.
The scale range of VAS is 0-10. Higher score indicates a higher intensity of pain.
The scale was assessed at baseline,4 week,8 week,12 week,24 week"|baseline,4 w,8 w,12 w,24 w|||units on a scale||Standard Deviation|Mean
832460|NCT01255761|Secondary|Interference With Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52|"The arthritis interference in the last month with household work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference).
The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient’s work productivity."|Week 52|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.||units on a scale||Standard Deviation|Mean
832461|NCT01255761|Secondary|Number of Days With Hired Outside Help (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52|Number of days with hired outside help in the last month. The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient’s work productivity.|Week 52|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.||Days with hired outside help||Standard Deviation|Mean
832462|NCT01255761|Secondary|Number of Days Missed of Family/Social/Leisure Activities (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52|Number of days missed of family/social/leisure activities in the last month. The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient’s work productivity.|Week 52|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.||Activity days missed||Standard Deviation|Mean
832463|NCT01255761|Secondary|Number of Days With Reduced Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52|Number of days with reduced household work productivity in the last month. The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient’s work productivity.|Week 52|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.||Days with reduced household work||Standard Deviation|Mean
832464|NCT01255761|Secondary|Number of Days With No Household Work (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52|Number of days with no household work in the last month. The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient’s work productivity.|Week 52|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.||Days with no household work||Standard Deviation|Mean
832465|NCT01255761|Secondary|Interference With Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52|"The arthritis interference in the last month with work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference).
The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient’s work productivity."|Week 52|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.||units on a scale||Standard Deviation|Mean
832466|NCT01255761|Secondary|Number of Work Days With Reduced Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52|Number of work days with reduced productivity in the last month. The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient’s work productivity.|Week 52|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.||Work days with reduced work productivity||Standard Deviation|Mean
832467|NCT01255761|Secondary|Number of Work Days Missed (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52|Number of work days missed in the last month. The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient’s work productivity.|Week 52|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.||Number of work days missed in last month||Standard Deviation|Mean
832468|NCT01255761|Secondary|Interference With Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12|"The arthritis interference in the last month with household work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference).
The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient’s work productivity."|Week 12|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.||units on a scale||Standard Deviation|Mean
832469|NCT01255761|Secondary|Number of Days With Hired Outside Help (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12|Number of days with hired outside help in the last month The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient’s work productivity.|Week 12|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.||Days with hired outside help||Standard Deviation|Mean
832470|NCT01255761|Secondary|Number of Days Missed of Family/Social/Leisure Activities (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12|Number of days missed of family/social/leisure activities in the last month The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient’s work productivity.|Week 12|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.||Activity days missed||Standard Deviation|Mean
832471|NCT01255761|Secondary|Number of Days With Reduced Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12|Number of days with reduced household work productivity in the last month The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient’s work productivity.|Week 12|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.||Days with reduced household work||Standard Deviation|Mean
832472|NCT01255761|Secondary|Number of Days With No Household Work (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12|Number of days with no household work in the last month The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient’s work productivity.|Week 12|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.||Days with no household work||Standard Deviation|Mean
832682|NCT01250730|Primary|Time to Cmax (Tmax) of Plasma Active Metabolite (PF-06260182)||0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose|||ng/mL||Full Range|Median
832473|NCT01255761|Secondary|Interference With Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12|The arthritis interference in the last month with work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference) The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient’s work productivity.|Week 12|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.||units on a scale||Standard Deviation|Mean
832474|NCT01255761|Secondary|Number of Work Days With Reduced Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12|Number of work days with reduced productivity in the last month The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient’s work productivity.|Week 12|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.||Work days with reduced work productivity||Standard Deviation|Mean
832475|NCT01255761|Secondary|Number of Work Days Missed (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12|Number of work days missed in the last month The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient’s work productivity.|Week 12|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.||Number of work days missed in last month||Standard Deviation|Mean
832476|NCT01255761|Secondary|Percentage of Subjects With RAPID3 (Routine Assessment of Patient Index Data) Remission (RAPID3 ≤ 3.0) at Week 52|"RAPID3 is the sum of the Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscores of physical function, pain, and patient’s global status.
The range for the RAPID3 is 0 - 30 with a negative change in RAPID3 score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity."|Week 52|Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).||percentage of subjects|||Number
832477|NCT01255761|Secondary|Percentage of Subjects With RAPID3 (Routine Assessment of Patient Index Data) Remission (RAPID3 ≤ 3.0) at Week 12|"RAPID3 is the sum of the Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscores of physical function, pain, and patient’s global status.
The range for the RAPID3 is 0 - 30 with a negative change in RAPID3 score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity."|Week 12|Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).||percentage of subjects|||Number
832478|NCT01255761|Secondary|Percentage of Subjects With RAPID3 (Routine Assessment of Patient Index Data) Low Disease Activity (RAPID3 ≤ 6.0) at Week 52|"RAPID3 is the sum of the Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscores of physical function, pain, and patient’s global status.
The range for the RAPID3 is 0 - 30 with a negative change in RAPID3 score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity."|Week 52|Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).||percentage of subjects|||Number
832479|NCT01255761|Secondary|Percentage of Subjects With RAPID3 (Routine Assessment of Patient Index Data) Low Disease Activity (RAPID3 ≤ 6.0) at Week 12|"RAPID3 is the sum of the Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscores of physical function, pain, and patient’s global status.
The range for the RAPID3 is 0 - 30 with a negative change in RAPID3 score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity."|Week 12|Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).||percentage of subjects|||Number
832480|NCT01255761|Secondary|Percentage of Subjects With CDAI (Clinical Disease Activity Index) Remission (CDAI ≤ 2.8) at Week 52|"CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined.
The range for the CDAI is 0 - 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity."|Week 52|Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).||percentage of subjects|||Number
832481|NCT01255761|Secondary|Percentage of Subjects With CDAI (Clinical Disease Activity Index) Remission (CDAI ≤ 2.8) at Week 12|"CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined.
The range for the CDAI is 0 - 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity."|Week 12|Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).||percentage of subjects|||Number
832509|NCT01256008|Primary|Hamilton Depression Rating Scale (HAMD-17)|"The scale(HAMD-17) is used to assessed the depression symptoms of patients.
The scale range is 0-53.Higher value represents a worse outcome.
The scale was assessed at baseline,2 week,4 week,8 week,12 week,16 week,24 week"|baseline,2 w,4 w,8 w,12 w,16 w,24 w|||units on a scale||Standard Deviation|Mean
832482|NCT01255761|Secondary|Percentage of Subjects With CDAI (Clinical Disease Activity Index) Low Disease Activity (CDAI ≤ 10) at Week 52|"CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined.
The range for the CDAI is 0 - 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity."|Week 52|Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).||percentage of subjects|||Number
832483|NCT01255761|Secondary|Percentage of Subjects With CDAI (Clinical Disease Activity Index) Low Disease Activity (CDAI ≤ 10) at Week 12|"CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined.
The range for the CDAI is 0 - 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity."|Week 12|Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).||percentage of subjects|||Number
832484|NCT01255761|Secondary|Percentage of Subjects With DAS28(ESR) (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Remission (DAS28[ESR] < 2.6) at Week 52|DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined. Lower scores indicate less disease activity.|Week 52|Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).||percentage of subjects|||Number
832485|NCT01255761|Secondary|Percentage of Subjects With DAS28(ESR) (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Remission (DAS [ESR] < 2.6) at Week 12|DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined. Lower scores indicate less disease activity.|Week 12|Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).||percentage of subjects|||Number
832486|NCT01255761|Secondary|Percentage of Subjects With DAS28(ESR) (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Low Disease Activity (DAS28[ESR] ≤ 3.2) at Week 52|DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, using this formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined. Lower scores indicate less disease activity.|Week 52|Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).||percentage of subjects|||Number
832487|NCT01255761|Secondary|Percentage of Subjects With DAS28(ESR) (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Low Disease Activity (DAS28[ESR] ≤ 3.2) at Week 12|DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, using this formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined. Lower scores indicate less disease activity.|Week 12|Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).||percentage of subjects|||Number
832488|NCT01255761|Secondary|Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Assessed at Week 52|"RAPID3 is the sum of the Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscores of physical function, pain, and patient’s global status.
The range for the RAPID3 is 0 - 30 with a negative change in RAPID3 score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity."|Baseline (Week 0) to Week 52|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement. The Last Observation Carried Forward (LOCF) was used for this analysis.||units on a scale||Standard Deviation|Mean
832489|NCT01255761|Secondary|Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Assessed at Week 12|"RAPID3 is the sum of the Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscores of physical function, pain, and patient’s global status.
The range for the RAPID3 is 0 - 30 with a negative change in RAPID3 score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity."|Baseline (Week 0) to Week 12|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement. The Last Observation Carried Forward (LOCF) was used for this analysis.||units on a scale||Standard Deviation|Mean
832510|NCT01256034|Secondary|Plasma IL-6, CRP, Th1/Th2 Balance||14 days||||||
832490|NCT01255761|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) Assessed at Week 52|"CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined.
The range for the CDAI is 0 - 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity."|Baseline (Week 0) to Week 52|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement. The Last Observation Carried Forward (LOCF) was used for this analysis.||units on a scale||Standard Deviation|Mean
832491|NCT01255761|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) Assessed at Week 12|"CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined.
The range for the CDAI is 0 - 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity."|Baseline (Week 0) to Week 12|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement. The Last Observation Carried Forward (LOCF) was used for this analysis.||units on a scale||Standard Deviation|Mean
832492|NCT01255761|Secondary|Change From Baseline in Disease Activity Score 28 Erythrocyte Sedimentation Rate [DAS28 (ESR)] Assessed at Week 52|"The DAS28(ESR) score is a measure of the subject's disease activity.
DAS28(ESR) is calculated from the tender joint count (28 joints), swollen joint count (28 joints), erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined. Lower scores indicate less disease activity."|Baseline (Week 0) to Week 52|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement. The Last Observation Carried Forward (LOCF) was used for this analysis.||units on a scale||Standard Deviation|Mean
832493|NCT01255761|Secondary|Change From Baseline in the Disease Activity Score 28 Erythrocyte Sedimentation Rate [DAS28 (ESR)] Assessed at Week 12|"The DAS28(ESR) score is a measure of the subject's disease activity.
DAS28(ESR) is calculated from the tender joint count (28 joints), swollen joint count (28 joints), erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined. Lower scores indicate less disease activity."|Baseline (Week 0) to Week 12|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement. The Last Observation Carried Forward (LOCF) was used for this analysis.||units on a scale||Standard Deviation|Mean
832494|NCT01255761|Secondary|Percentage of All Subjects Who Are Both Responders at Week 12 and With Non-remission (Disease Activity Score 28 [Erythrocyte Sedimentation Rate] > 2.6) at Week 52|"For subjects randomized to CDAI, response is defined as CDAI ≤10 or 20% improvement from Baseline. For subjects randomized to RAPID3, response is defined as RAPID3 ≤6 or 20% improvement from Baseline.
DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56x√(TJC) + 0.28x√(SJC) + 0.70xlognat (ESR) + 0.014xGlobal Assessment of Arthritis where 28 joints are examined."|Baseline (Week 0) to Week 52|Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).||percentage of participants|||Number
832495|NCT01255761|Secondary|Responders at Week 12 Achieving Remission (Disease Activity Score 28 [Erythrocyte Sedimentation Rate] < 2.6) at Week 52|"For subjects randomized to CDAI, response is defined as CDAI ≤10 or 20% improvement from Baseline. For subjects randomized to RAPID3, response is defined as RAPID3 ≤6 or 20% improvement from Baseline.
DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56x√(TJC) + 0.28x√(SJC) + 0.70xlognat (ESR) + 0.014xGlobal Assessment of Arthritis where 28 joints are examined."|Baseline (Week 0) to Week 52|"The measurement only includes subjects that were responders at Week 12, and this is the denominator for the percentages.
The Full Analysis Set (FAS)-Nonresponse imputation (NRI) population set was used for this analysis."||percentage of participants|||Number
832496|NCT01255761|Secondary|Percentage of All Subjects Who Are Both Responders at Week 12 and With Non-low Disease Activity (Disease Activity Score 28 [Erythrocyte Sedimentation Rate] > 3.2) at Week 52|"For subjects randomized to CDAI, response is defined as CDAI ≤10 or 20% improvement from Baseline. For subjects randomized to RAPID3, response is defined as RAPID3 ≤6 or 20% improvement from Baseline.
DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56x√(TJC) + 0.28x√(SJC) + 0.70xlognat (ESR) + 0.014xGlobal Assessment of Arthritis where 28 joints are examined."|Baseline (Week 0) to Week 52|Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).||percentage of participants|||Number
832511|NCT01256034|Primary|Postoperative Infectious Complication||30 days|||participants|||Number
832512|NCT01256060|Other Pre-specified|Measures of Social Function - The Clinical Global Impressions - Social Scale (Baseline to Week 12)|"Social Function
a) Clinical Global Impressions - Social Scale (1-7) (lower score=positive response). The results will be reported as the number of participants that were classified as a social responder (achieving a score of 1 or 2 on the scale)."|12 Weeks|||participants|||Number
832497|NCT01255761|Primary|Responders at Week 12 (as Assessed by Randomized Tool Clinical Disease Activity Index [CDAI] or Routine Assessment of Patient Index Data [RAPID3]) Achieving Low Disease Activity (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]≤3.2) at Week 52|"For subjects randomized to CDAI, response is defined as CDAI ≤10 or 20% improvement from Baseline. For subjects randomized to RAPID3, response is defined as RAPID3 ≤6 or 20% improvement from Baseline.
DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56x√(TJC) + 0.28x√(SJC) + 0.70xlognat (ESR) + 0.014xGlobal Assessment of Arthritis where 28 joints are examined."|Baseline (Week 0) to Week 52|Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).||percentage of participants|||Number
832498|NCT01255761|Primary|Response at Week 12 as Assessed by Randomized Tool [Clinical Disease Activity Index (CDAI) or Routine Assessment of Patient Index Data 3 (RAPID3)]|"For subjects randomized to CDAI, response is defined as CDAI ≤10 or 20% improvement from Baseline. For subjects randomized to RAPID3, response is defined as RAPID3 ≤6 or 20% improvement from Baseline.
CDAI is the sum of tender joint count, swollen joint count, Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, and Investigator's Global Assessment of Disease Activity - VAS (VAS in cm). 28 joints are examined.
RAPID3 is the sum of the MDHAQ subscores of physical function, pain, and patient’s global status."|Baseline (Week 0) to Week 12|Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).||percentage of participants|||Number
832499|NCT01255787|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and family life or home responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from an ANCOVA model with treatment as a fixed factor and the Baseline value as a covariate.|Baseline and Week 8|Full analysis set, only participants with Baseline and at least 1 post-baseline value are included. LOCF was used.||scores on a scale||Standard Error|Least Squares Mean
832500|NCT01255787|Secondary|Mean Clinical Global Impression Scale - Improvement (CGI-I) Score at Week 8|The Clinical Global Impression - Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from an ANCOVA model with treatment as a fixed factor and the Baseline Clinical Global Impression-Severity of Illness (CGI-S) score as a covariate.|Week 8|Full analysis set, only participants with Baseline and at least 1 post-baseline value are included. LOCF was used.||scores on a scale||Standard Error|Least Squares Mean
832501|NCT01255787|Secondary|Percentage of Participants in MADRS Remission at Week 8|Remission is defined as a participant with a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≤10. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.|Week 8|Full analysis set, only participants with Baseline and at least 1 post-baseline value are included. LOCF was used.||percentage of participants|||Number
832502|NCT01255787|Secondary|Percentage of Participants With a MADRS Response at Week 8|Response is defined as a participant with a ≥50% decrease in Montgomery Åsberg Depression Rating Scale (MADRS) total score from Baseline. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.|Baseline and Week 8|Full analysis set, only participants with Baseline and at least 1 post-baseline value are included. LOCF was used.||percentage of participants|||Number
832503|NCT01255787|Primary|Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score|The MADRS is a depression rating scale consisting of 10 items, each rated 0 (normal) to 6 (most abnormal). The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. Least squares (LS) means were from an Analysis of Covariance (ANCOVA) model with treatment as a fixed factor and the Baseline value as a covariate.|Baseline and Week 8|The full analysis set included all randomized participants who received at least 1 dose of study drug. One patient in the placebo arm was excluded from all datasets due to enrollment in another clinical study. Only participants with Baseline and at least 1 post-baseline value are included. Last observation carried forward (LOCF) was used.||scores on a scale||Standard Error|Least Squares Mean
832504|NCT01255904|Primary|Time to Complete Study|Time from medication administration to study completion.|60-180 minutes|||Minutes||95% Confidence Interval|Median
832505|NCT01256008|Secondary|Functional Assessment of Cancer Treatment (FACT-B)|"The scale is used to assess the life quality of patients.
The scale includes 5 subscales. The scores of each scale are summed to compute a total score.
The scale range is 0-144. Higher score indicates better life quality.
The scale was assessed at baseline,4 week,12 week,24 week."|baseline, 4w,12w,24w|||units on a scale||Standard Deviation|Mean
832506|NCT01256008|Secondary|Athens Insomnia Scale(AIS)|"The scale is used to assess the sleep quality of patients.
The scale range of AIS is 0-21. Higher score indicates worse sleep quality.
The scale was assessed at baseline,4 week,8 week,12 week,24 week"|baseline, 4w,8w,12w,24w|||units on a scale||Standard Deviation|Mean
832507|NCT01256008|Primary|Hamilton Anxiety Scale (HAMA-14)|"The scale(HAMA-14) is used to assessed the anxiety symptoms of patients.
The scale range is 0-56.Higher value represents a worse outcome.
The scale was assessed at baseline,2 week,4 week,8 week,12 week,16 week,24 week."|baseline,2 w,4 w,8 w,12 w,16 w,24 w|||units on a scale||Standard Deviation|Mean
832513|NCT01256060|Other Pre-specified|Changes in Measures of Social Cognition, Social Function, Repetitive Behaviors, and Anxiety (Baseline to Week 12)|"Social Cognition (higher score=positive response)
Let's Face It Skills Battery; i. Matchmaker (0-100); ii. Faces (0-100); iii. Houses (0-100)
Eyes Test (0-28)
Strange Stories (0-16)
Irony and Empathy (0-24)
Social Function
Aberrant Behavior Checklist (0-48) (lower score=positive response)
Behavioral Assessment System for Children (higher score=positive response); i. Social: age 8 to 11 & 15 to 18 (18-69); age 12 to 14 (21-70); ii. Functional: age 8 to 14 (10-66); age 15 to 18 (10-64)
Social Responsiveness Scale (higher score=positive response); male (34-127); female (35-142)
Anxiety (lower score=positive response)
a. Child Symptom Inventory; i. Separation: male (44-106); female (44-101); ii. Generalized: male (40-101); female (41-96)
Repetitive Behaviors (lower score=positive response)
Child Yale-Brown Obsessive-Compulsive Scale (0-20)
Repetitive Behavior Scale (0-129)
Measures insensitive to change will be omitted from results."|12 Weeks|||units on a scale||95% Confidence Interval|Mean
832514|NCT01256060|Secondary|Blood Levels of Oxytocin During the Trial in Relation to Safety or Treatment Response|Children and adolescents with minimal changes in plasma level of oxytocin after treatment will be less responsive to treatment. Children and adolescents with atypical patterns of increase in oxytocin may be more sensitive to dose-related tolerability.|12 Weeks||12/2016||||
832515|NCT01256060|Secondary|Baseline Levels of Oxytocin in Relation to Either Safety or Treatment Response|Children and adolescents with lower plasma oxytocin levels at baseline will show treatment related changes in social cognition. Children and adolescents with higher oxytocin plasma levels will show diminished or less dramatic treatment responses and may have more difficulty tolerating the treatment.|12 Weeks||12/2016||||
832516|NCT01256060|Primary|Number of Participants With Serious Adverse Events|This will be reported as the number of participants who experienced a serious advert event throughout the study.|24 Weeks|||participants|||Number
832517|NCT01256060|Primary|Maximum Tolerated Dose (MTD)|The hypothesis is that the maximum tolerated dose in a range of 0.2-0.4 IU/kg / dose will be 0.4 IU/kg / dose, as was the case in the adult study, given that oxytocin is not stored in body fat and does not depend on liver or renal clearance.|12 Weeks|||IU / kg|||Number
832518|NCT01256086|Primary|PC20 = Provocation Concentration of Methacholine That Cause a 20% Decrease in Forced Expiratory Volume in the First Second (FEV1)|The primary variable is the methacholine PC20 after inhalation of study medication; the PC20 is the concentration of methacholine that - despite protection by study medication - causes a 20% fall in FEV1 compared to the pre-methacholine (post-saline) level of the given study day.|60 min after application of study medication|Per Protocol Population||mg/ml||Geometric Coefficient of Variation|Geometric Mean
832519|NCT01256164|Secondary|Number of Patients Achieving Hemostasis at 10 Minutes||10 minutes|||participants|||Number
832520|NCT01256164|Secondary|Number of Participants Achieving Hemostasis at 5 Minutes||5 minutes|||participants|||Number
832521|NCT01256164|Secondary|Number of Subjects Achieving Hemostasis at 3 Minutes||3 minutes|||participants|||Number
832522|NCT01256164|Secondary|Safety|Number of participants with Adverse events and clinically-significant changes/findings on labs and physical examination as well as incidence of re-operation for bleeding at the TBS|28 Days|All subjects treated were analyzed for safety.||participants|||Number
832523|NCT01256164|Primary|Mean Time to Hemostasis (TTH)|Time to hemostasis recorded from the first application of study treatment until cessation of bleeding|0-10 minutes|All subjects treated with a time to hemostasis were included in the analysis||minutes||Standard Deviation|Mean
832524|NCT01256177|Secondary|Incidence of Treatment-emergent Mania (AE of Mania or Hypomania, Defined as Young Mania Rating Scale [YMRS] Score ≥16 on 2 Consecutive Assessments or Final Assessment)|The incidence of treatment-emergent mania is defined as ≥16 of YMRS total score on 2 consecutive assessments or at final assessment, YMRS total score range: 0-60, the higher is the total score the more severe is the disease.|After 8 weeks of start of treatment|Full Analysis Set||Participants|||Number
832525|NCT01256177|Secondary|Change From Baseline to Week 8 in Item 10 of Montgomery-Asberg Depression Rating Scale (MADRS) for Suicidal Ideation|MADRS item 10 (suicidal ideation) score range: 0 to 6, the higher the score, the more severe, Change: MADRS item 10 score at week 8 minus score at baseline|Baseline to Week 8|Full Analysis Set (Number of Participants at Week 8: Placebo=100; Quetiapine XR=114)||Scores on a scale||Standard Error|Least Squares Mean
832526|NCT01256177|Secondary|The Proportion of Patients at Week 8 With a Clinical Global Impression – Bipolar - Change (CGI-BP-C) of “Much” or “Very Much” Improved|Clinical Global Impression - Bipolar - Change (CGI-BP-C) of “much” or “Very much” improved is defined as a change in CGI-BP overall bipolar illness score ≤ 2 where 1 = very much improved, 2 = much improved.|After 8 weeks of start of treatment|Full Analysis Set||Participants|||Number
832527|NCT01256177|Secondary|Change From Baseline to Week 8 Assessment in the Clinical Global Impression Bipolar – Severity (CGI-BP-S)|CGI-BP severity of illness-Overall bipolar range = 1-7, the higher is the total score,the more severe is the disease. CGI-BP severity of illness-Depression range: 1-7, the higher is the total score, the more severe is the disease|Baseline to Week 8|Full Anlaysis Set (Number of Participants at Week 8: Placebo=100; Quetiapine XR=112)||Scores on a scale||Standard Error|Least Squares Mean
832528|NCT01256177|Secondary|Change From Baseline to Week 8 in HAM-D Total Scores|HAM-D total score range: 0 to 53, the higher the score, the more severe. Change : Total HAM-D score at week 8 minus score at baseline|Baseline to Week 8|Full Analysis Set (Number of Participants at Week 8: Placebo=100; Quetiapine XR=114).||Scores on a scale||Standard Error|Least Squares Mean
832529|NCT01256177|Secondary|Change From Baseline to Each Assessment in MADRS Total Score|MADRS total score range: 0 to 60, the higher the score, the more severe.|Baseline to Week 8|Full Analysis Set (Number of participants at each assessment : Baseline (Placebo=140, Quetiapine XR= 139), Week 1 (Placebo=140, Quetiapine XR= 139), Week 2 (Placebo=127, Quetiapine XR= 128), Week 4 (Placebo=114, Quetiapine XR= 120), Week 6 (Placebo=102, Quetiapine XR= 114), Week 8 (Placebo=100, Quetiapine XR= 114)).||Scores on a scale||Standard Error|Least Squares Mean
832530|NCT01256177|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Remission (the Proportion of Subjects With a MADRS Total Score ≤ 12 at Week 8 Assessment)|Montgomery-Asberg Depression Rating Scale (MADRS) total score range: 0 to 60, the higher the score, the more severe, Remission was defined as MADRS total score ≤12|After 8 week of start of treatment|Full Analysis Set||Participants|||Number
832531|NCT01256177|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Response (Subjects With ≥50% Reduction From Baseline to Week 8 in MADRS Total Score)|Montgomery-Asberg Depression Rating Scale (MADRS) total score range: 0 to 60, the higher the score, the more severe, Response was defined as ≥50% reduction in MADRS total score from baseline|8 weeks from baseline|Full Analysis set||Participants|||Number
832532|NCT01256177|Primary|Change From Baseline (Visit 2) to End of Study (Week 8) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|MADRS total score range: 0 to 60, the higher the score, the more severe, Change : Total MADRS score at week 8 minus score at baseline|Baseline to Week 8|Full Analysis Set (Number of participants at Week 8: Placebo=100; Quetiapine XR=114)||Scores on a scale||Standard Error|Least Squares Mean
832533|NCT01256190|Secondary|Number of Patients Achieving Hemostasis at 10 Minutes||10 minutes|||participants|||Number
832534|NCT01256190|Secondary|Number of Subjects Achieving Hemostasis at 3 Minutes||3 minutes|||participants|||Number
832535|NCT01256190|Secondary|Incidence of Hemostasis at 5 Minutes|Number of subjects in each group that achieved hemostasis at pre-specified times after treatment|5 minutes|||participants|||Number
832536|NCT01256190|Secondary|Safety|Number of participants with Adverse events and clinically significant changes/findings on labs and physical examination as well as incidence of re-operation for bleeding at the target bleeding site (TBS)|28 days|All subjects treated were analyzed for safety. There were 39 subjects treated with Fibrocaps and 16 treated with gelatin sponge only, since 1 gel sponge subject was randomized but not treated.||participants|||Number
832537|NCT01256190|Primary|Time to Hemostasis|Time from application of treatment to cessation of bleeding|0-10 minutes|All subjects treated with a time to hemostasis were included in the analysis||minutes||Standard Deviation|Mean
832538|NCT01256281|Primary|Pain Score in Legs (0-10)|"Pain score in legs at 2-4 hours after intervention will be the primary outcome.
Data analysis not done."|2-4 hours after intervention||||||
832539|NCT01256294|Primary|Dose-normalized Maximum Plasma Drug Concentration (Cmax) at Steady State|Maximum (peak) plasma drug concentration after drug administration at steady state (after 14 days of treatment with each study drug). Geometric mean and 95% confidence intervals were determined from an analysis of variance (ANOVA) model for the dose-normalized log transformed values with treatment, period and sequence as fixed factors and patients nested within sequences as a random factor.|Days 14 and 28: Predose and at 0.5, 1, 1.5, 1.75, 2, 3, 4, 8 and 12 hours after dosing.|Pharmacokinetic (PK) analysis set included the subset of patients from the Full Analysis Set (all patients to whom study medication had been assigned) with evaluable PK data.||ng/mL/mg||95% Confidence Interval|Geometric Mean
832540|NCT01256294|Secondary|Number of Participants With Reported Biopsy Proven Acute Rejection Episodes||28 Days|Full analysis set.||participants|||Number
832541|NCT01256294|Secondary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|An AE was defined as the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event was not considered to be related to study drug. An SAE was an event which: was fatal or life-threatening; resulted in persistent or significant disability/incapacity; constituted a congenital anomaly/birth defect; required or prolonged inpatient hospitalization; was medically significant, i.e., an event that jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above.|28 Days|Safety set||participants|||Number
832542|NCT01256294|Secondary|Trough Plasma Drug Concentration (C0) at Steady State|Trough plasma drug concentration measured prior to drug administration at steady state (after 14 days of treatment with each study drug).|Days 14 and 28: predose|PK analysis set, where data were available.||ng/mL||Standard Deviation|Mean
832543|NCT01256294|Secondary|Intra-patient Variability of Tacrolimus Pharmacokinetic Parameters|The intra-patient variability of tacrolimus pharmacokinetics of each formulation was evaluated by comparing AUC0-12h, maximum drug concentration (Cmax) and trough drug concentration (C0) at Days 7 and 14, and Days 21 and 28. Intra-patient variability was assessed by a calculation of the coefficient of variation, by patient, using the repeated measurements within each Period, where the coefficient of variation (%) = standard deviation/mean*100.|Days 7 and 14, and Days 21 and 28.|PK Analysis set.||percent coefficient of variation||Standard Error|Mean
832544|NCT01256294|Primary|Dose-Normalized Area Under the Concentration-time Curve From Time 0 to 12 Hours (AUC0-12h) at Steady State|"Dose-normalized area under the concentration-time curve from time 0 to 12 hours (AUC0-12h) at steady state after 14 days of treatment with each study drug.
Geometric mean and 95% confidence intervals were determined from an analysis of variance (ANOVA) model for the dose-normalized log transformed values with treatment, period and sequence as fixed factors and patients nested within sequences as a random factor."|Days 14 and 28: Predose and at 0.5, 1, 1.5, 1.75, 2, 3, 4, 8 and 12 hours after dosing.|Pharmacokinetic (PK) analysis set included the subset of patients from the Full Analysis Set (all patients to whom study medication had been assigned) with evaluable PK data.||ng*hr/mL/mg||95% Confidence Interval|Geometric Mean
832545|NCT01256385|Secondary|Percentage of Responses/Disease Stabilization for Patients Crossing Over to the Combination Therapy After Progressing on Arm B.|Assessed according to RECIST. This is includes complete and partial responses as well as stable disease, and is different from Outcome Measure 6 above, which includes only complete and partial responses.|Up to 5 years|||percentage of participants||95% Confidence Interval|Number
832546|NCT01256385|Secondary|PFS of Myofibroblast (+) Cohort||From start of treatment to time of progression or death of any cause, assessed up to 5 years|Myofibroblast status was not determined. Concerns about the validity/technical feasibility as well as availability of the assay led us to decide to not perform the assay. We do not intend to perform this assay anymore.|||||
832547|NCT01256385|Secondary|Percentage of Responses After Crossover From Control Arm to the Combination Arm, Assessed According to RECIST|Percentage of responses (if any) after crossover from the control arm to the combination arm will be evaluated qualitatively. This is includes complete and partial responses, and is different from Outcome Measure 8 below, which includes complete and partial responses as well as stable disease.|Up to 5 years|||percentage of participants||95% Confidence Interval|Number
832548|NCT01256385|Secondary|Grade 3 or Higher Hematological Toxicity|Incidence of hematological toxicities at least possibly related to study drug, graded based on Common Terminology Criteria for Adverse Events version 4|Up to 5 years|||percentage of participants||95% Confidence Interval|Number
832549|NCT01256385|Secondary|PFS vs. Historical Control Cohort|PFS at 4 months in Arm A and Arm B will each be compared with a 4-month historical control rate of 21.4%. The historical data appears in two publications, an ASCO abstract: Abidoye, ASCO Annual Meeting 2006: 5568 and de Souza, Davis, et al, Clin Cancer Res 2012; 18(8):2336-2343.|From start of treatment to time of progression or death of any cause, assessed at 4 months|Note: Each arm is separately compared to an historical rate of 21.4%, based on a one-sided test at the 0.05 significant level. Since the 90% CIs each exclude 21.4%, the 4-month PFS rate in both arms exceeds the fixed historical control rate.||percentage of participants||90% Confidence Interval|Number
832550|NCT01256385|Secondary|Overall Response Rates (OR)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Statistics reported are for Overall Response (OR) = CR + PR.|Up to 5 years|||percentage of participants||95% Confidence Interval|Number
832551|NCT01256385|Secondary|Overall Survival (OS)|Time from randomization until death from any cause|Up to 5 years|||days||95% Confidence Interval|Median
832552|NCT01256385|Primary|Progression-free Survival (PFS)|Progression determined using RECIST criteria: >=20% increase in the sum of the longest diameters of target lesions from nadir, occurrence of new lesions, or progression of non-target lesions.|From start of treatment to time of progression or death from any cause, assessed up to 5 years|||days||95% Confidence Interval|Median
832553|NCT01256411|Secondary|Number of Participants With Blood Pressure Control Rate of <140/90 mmHg (Analysis by Mono or Combination Therapy)|Blood pressure (BP) control is defined as BP <140/90 mmHg.|Baseline to 12 months|Treated set: The treated set included all participants who received at least one dose of extension study medication. One participant in the LCZ696 combination group discontinued after 1 day in the extension study without having any BP measurements taken during the extension. Therefore, this participant was excluded from the analysis.||Participants|||Number
832554|NCT01256411|Secondary|Number of Participants With Blood Pressure Control Rate of <140/90 mmHg (Analysis by Maximum Treatment)|Blood pressure (BP) control is defined as BP <140/90 mmHg.|Baseline to 12 months|Treated set: The treated set included all participants who received at least one dose of extension study medication. One participant in the LCZ696 400 mg/Amlodopine group discontinued after 1 day in the extension study without having any BP measurements taken during the extension. Therefore, this participant was excluded from the analysis.||Participants|||Number
832555|NCT01256411|Secondary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) (Analysis by Mono or Combination Therapy)|Sitting BP measurements were performed at every study visit. A negative change from baseline indicates improvement.|Baseline, 12 months|Treated set: The treated set included all participants who received at least one dose of extension study medication. One participant in the LCZ696 combination group discontinued after 1 day in the extension study without having any BP measurements taken during the extension. Therefore, this participant was excluded from the analysis.||mmHg||Standard Deviation|Mean
832556|NCT01256411|Secondary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) (Analysis by Maximum Treatment)|Sitting BP measurements were performed at every study visit. A negative change from baseline indicates improvement.|Baseline, 12 months|Treated set: The treated set included all participants who received at least one dose of extension study medication. One participant in the LCZ696 400 mg/Amlodopine group discontinued after 1 day in the extension study without having any BP measurements taken during the extension. Therefore, this participant was excluded from the analysis.||mmHg||Standard Deviation|Mean
832557|NCT01256411|Primary|Number of Participants With Adverse Events, Serious Adverse Events, and Deaths (Analysis by Actual Treatment)|Participants were monitored throughout the study for adverse events, serious adverse events and deaths.|Baseline to 12 months|Actual extension treatment received: The participants are included in each treatment group for which they received treatment. For example, if a participant started on LCZ696 200 mg but was then down-titrated to LCZ696 100 mg, the participant was counted once in the LCZ696 100 mg group and once in the LCZ696 200 mg group.||Participants|||Number
832558|NCT01256424|Post-Hoc|Comparison of Response Rates of Three Different Doses of HAL PDT and Placebo at 9 Months After First Treatment|Response was defined as absence of HSIL, and absence of oncogenic HPF if LSIL|9 months after first treatment|Patients diagnosed with HSIL histology by a panel of pathologists were included in the analysis.||percentage of participants|||Number
832559|NCT01256424|Post-Hoc|Comparison of Response Rates of Three Different Doses of HAL PDT and Placebo at 6 Months After First Treatment.|Response was defined as absence of HSIL, and absence of oncogenic HPV if LSIL.|6 months after first treatment|Patients diagnosed with HSIL histology by a panel of pathologists were included in the analysis.||percentage of participants|||Number
832560|NCT01256424|Secondary|Comparison of HPV Response of Three Different Doses of HAL PDT and Placebo at 3 Months After Treatment.|HPV response was defined as clearance of baseline HPV infection, asssessed by genotype|3 months after treatment|Patients with CIN2 at baseline, based on central histology read, and HPV positive at baseline||percentage of patients|||Number
832561|NCT01256424|Primary|Comparison of Lesion Response Rates of Three Different Doses of HAL PDT and Placebo at 3 Months After Treatment.|Lesion response was defined by three variables: Histology, cytology and HPV. Patient response at three months required histology regression to CIN1 or normal, cytology of LSIL or less severe, and HPV negative.|3 months after last treatment|Patients with CIN2 at baseline, based on central histology review||percentage of patients|||Number
832562|NCT01256450|Secondary|Use of Rescue Medication|Calculated from the use of rescue medication recorded in subject diary as the sum of all rescue medication tablets used in the last 7 days previous to the derived visit, divided by the number of days in this duration where the amount was reported.|Day 7, 14, 28, 42, 56, 70, 84, and 91 within double-blind treatment phase|Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication||Tablets per day||Standard Deviation|Mean
832563|NCT01256450|Secondary|Change From Baseline to Week 12 in Investigator’s Overall Satisfaction With Study Drug|Investigators rated their overall satisfaction with the study drug administered to a given subject on a 5-point scale ranging from 1 (poor) to 5 (excellent).|Baseline, Week 12|Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication.||units on a scale||Standard Deviation|Mean
832564|NCT01256450|Secondary|Change From Baseline to Week 12 in Subject’s Overall Satisfaction With Study Drug|Subjects were asked to rate their overall satisfaction with their study drug on a 5-point scale ranging from 1 (poor) to 5 (excellent).|Baseline, Week 12|Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication.||units on a scale||Standard Deviation|Mean
832565|NCT01256450|Secondary|Change From Baseline to Week 12 in Roland Morris Disability Questionnaire|Subjects assess disability due to back pain using the Roland Morris Disability Questionnaire (RMDQ) consisting of 24 statements of disability. The score of the RMDQ is the total number of items checked, ranging from 0 to 24 with higher scores indicating greater disability.|Baseline, Week 12|Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication||units on a scale||Standard Deviation|Mean
832566|NCT01256450|Secondary|Change From Baseline to Week 12 in Treatment Satisfaction Using TSQM|The Treatment Satisfaction Questionnaire for Medication (TSQM) is a 14-item instrument used to assess the subject’s satisfaction with the ability of the study medication to prevent or treat the condition of chronic low back pain (CLBP) for effectiveness, side effects, convenience, and global satisfaction. Scores range from 0 to 100, where a higher score indicates less dissatisfaction (ie, greater satisfaction).|Baseline, Week 12|Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication.||units on a scale||Standard Deviation|Mean
832567|NCT01256450|Secondary|Subject Impression of Change in Pain Intensity From Baseline to Week 12 Using PGIC Scale|Subjects assessed changes in activity, limitations, symptoms, and overall quality of life related to their painful condition since beginning treatment using the Patient Global Impression of Change (PGIC), a balanced 7-point scale from 1 (no change or condition got worse) to 7 (a great deal better and considerable improvement that has made all the difference).|Baseline, Week 12|Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication.||units on a scale||Standard Deviation|Mean
832568|NCT01256450|Secondary|Percentage of Participants With Treatment Failure in the Double-blind Treatment Phase (up to 12 Weeks)|Treatment failure is defined as study discontinuation due to lack of efficacy or due to adverse event in the double-blind treatment phase.|Baseline to treatment failure or end of double-blind treatment phase (up to 12 weeks)|Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication.||percentage of participants|||Number
832569|NCT01256450|Secondary|Number of Participants With Response to Treatment as Assessed by an NRS Scale|Responses are defined as the relative improvement in pain score at week 12 from baseline, calculated from ratings of average pain intensity over the last 24 hours on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).|Week 12|Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication.||participants|||Number
832570|NCT01256450|Secondary|Change From Baseline in Pain Intensity Over Time Using NRS Scale|Change in pain intensity = average of daily pain scores from the last 7 days prior to each visit – average of daily pain scores for the last 7 days prior to randomization. Average pain intensity over the last 24 hours was rated on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).|Baseline; Day 14, Day 28, Day 42, Day 56, Day 70, and Day 84|Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication.||units on a scale||Standard Deviation|Mean
832571|NCT01256450|Primary|Change in Pain Intensity From Baseline to Week 12|Change in pain intensity = average of daily pain scores from the last 7 days prior to week 12 visit – average of daily pain scores for the last 7 days prior to randomization. Average pain intensity over the last 24 hours was rated on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).|Baseline, Week 12|Analysis based on Intent-to-Treat (ITT) population; all randomized subjects who received at least 1 dose of double-blind study medication.||units on a scale||Standard Deviation|Mean
832572|NCT01256476|Primary|Mean Percent Change in Low Density Lipoprotein Cholesterol(LDL-C) From Baseline to Week 12||Baseline and 12 weeks|All randomized subjects who took at least 1 dose of double-blind study drug, had a baseline efficacy measurement, and had at least 1 valid post-baseline efficacy measurement.||percent||Standard Error|Mean
832573|NCT01256502|Secondary|Investigator Satisfaction Following Use of SERI® Surgical Scaffold at Other Time Points|Investigator satisfaction with SERI® Surgical Scaffold was evaluated at Stage II surgery and Months 12, 18 and 24 after surgery/implantation using an 11-point scale, where 0=very dissatisfied to 10=very satisfied.|Stage 2 Surgery, Months 12, 18 and 24|Participants from the Full Analysis population (139 participants, 214 breasts), all enrolled participants who had SERI® Surgical Scaffold surgery/implant, with data at the given time-point.||units on a scale||Standard Deviation|Mean
832574|NCT01256502|Secondary|Investigator Ease of Use Assessment at the Time of SERI® Placement During Stage I Surgery|Ease of Use assessments of SERI® Surgical Scaffold by the investigator were collected on Case Report Forms (CRFs) following stage I surgery. Ease of Use was assessed separately using a 5-point scale, where 0=very difficult to 5=very easy to use for the following criteria: • SERI® preparation before implantation (excluding cutting or shaping) • SERI® cutting and shaping before implantation • SERI® positioning/drapability during implantation • SERI® cutting and shaping after implantation • SERI® suturing during implantation (including tension and stretch). The number of participants who were implanted with SERI® Surgical Scaffold (n=139) by Investigator Ease of Use response for each category is reported.|Immediately following Stage I surgery|Full analysis population included all enrolled participants who had SERI® Placement during Stage I Surgery.||participants|||Number
832575|NCT01256502|Primary|Investigator Satisfaction Following Use of SERI® Surgical Scaffold at 6 Months|The primary outcome measure was investigator satisfaction at 6 months after stage I surgery/implantation of SERI® Surgical Scaffold. Satisfaction was evaluated using an 11-point scale, where 0=very dissatisfied to 10=very satisfied.|6 months|Of the 139 participants, 214 breasts, implanted with SERI® during Stage I breast reconstruction, 4 discontinued the study and 1 missed the 6-month visit, leaving 134 subjects, 205 breasts in the primary analysis population.||units on a scale||Standard Deviation|Mean
832576|NCT01256567|Secondary|Steady State Volume of Distribution (Vss) of Ramucirumab||Day 1 of Cycle 1 and 4 (cycle=21 days)|All participants with evaluable Vss data at the specified time points.||liters (L)||Geometric Coefficient of Variation|Geometric Mean
832579|NCT01256567|Secondary|Area Under the Curve (AUC) of Ramucirumab|AUC from time zero to infinity (AUC[0-inf], Cycle 1) and at steady state (AUC tau, Cycle 4) of ramucirumab are provided.|Day 1 of Cycles 1 and 4 (cycle=21 days)|All participants with evaluable AUC data at the specified time points.||micrograms*day/milliliter (mcg*day/mL)||Geometric Coefficient of Variation|Geometric Mean
832580|NCT01256567|Secondary|Maximum Concentration (Cmax) of Ramucirumab|Cmax (Cycle 1) and Cmax at steady state (Cmax,ss, Cycle 4) of ramucirumab are provided.|Day 1 of Cycle 1 and Cycle 4 (cycle=21 days)|All participants with evaluable Cmax data at the specified time points.||micrograms per milliliter (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
832581|NCT01256567|Secondary|Serum Anti-IMC-1121B Antibody Assessment (Immunogenicity)|The number of participants with a positive anti-IMC-1121B titer at any point during the study.|Baseline up to data cut off (approximately 48.3 weeks)|All participants with evaluable antibody assessment data.||participants|||Number
832582|NCT01256567|Primary|Number of Participants With Adverse Events|Number participants with drug related dose-limiting toxicities (DLT) during Cycle 1; ramucirumab related: treatment-emergent adverse events (TEAE), serious adverse events (SAE), Grade 3 or higher TEAE, or TEAE leading to discontinuation or ramucirumab dose modification. DLT=G4 neutropenia >7days; G ≥3 neutropenia with fever ≥38.5°C requiring IV antibiotics or bacteriemia or sepsis; G4 thrombocytopenia; G ≥3 thrombocytopenia with bleeding requiring platelets; G≥3 prothrombin time and/or partial thromboplastin time in absence of anticoagulants; G≥2 hyperbilirubinemia ≥5 days; QTc >500 milliseconds (ms) or increase ≥100 ms or arrhythmia; G≥4 or uncontrollable hypertension; G≥3 nonhematologic toxicity (excluding G3: hypersensitivity, injection-site reaction, arthralgia/myalgia, asthenia/fatigue, diarrhea without loperamide therapy, nausea/vomiting without antiemetics, transient G3/4 elevation of aminotransferases); treatment delay >2 weeks due to toxicity.|Baseline up to data cut off (approximately 48.3 weeks)|All participants who received at least 1 dose of study drug.||participants|||Number
832583|NCT01256658|Secondary|Cumulative Number of Subjects With Symptomatic Malaria Episode, RDT-confirmed, With Parasitemia ≥5000/μL From Week 1 to Week 50|"Cumulative number of asymptomatic carriers having Symptomatic malaria episode, RDT-confirmed, with parasitemia ≥5000/μL (SMRC5000) from Week 1 to Week 50, was measured from group of participants diagnosed as asymptomatic carriers at Community Screening Campaign (CSC1)/Day1. Number of participants affected before and after diagnosed with ≥1 symptomatic malaria episode, RDT-confirmed, with parasitemia ≥5000/μL (SMRC5000) (complicated and uncomplicated episodes combined). Number of SMRC5000s was detected by Rapid Diagnostic Test (RDT) using a blood sample from each participant and later confirmed to have a parasite density > or = 5000/uL by microscopy.
Week (1-2) indicates day1 to day14, week (3-4) indicates day 15 to day 28, week (5-6) indicates day 29 to day 42, etc. After first diagnosis of asymptomatic carriers at CSC1/Day1."|Week 1 to Week 50|Individual subject data from eligible randomized participants from Community Screening Campaign 1 (CSC1) for which data on Symptomatic malaria episode, RDT-confirmed (SMRCs) was collected and available form analysis and census data was obtained as per protocol.||participants|||Number
832584|NCT01256658|Secondary|Number of Asymptomatic Carriers With Complicated and Uncomplicated Episodes Combined|Number of asymptomatic carriers diagnosed with 1 Symptomatic malaria episode, RDT-confirmed, with parasitemia ≥5000/μL (SMRC5000), 2 SMRC5000, 3 SMRC5000 and >3 SMRC5000 (complicated and uncomplicated episodes combined). Number of SMRC5000s is measured by Rapid diagnostic test (RDT) and later confirmed to have a parasite density ≥ 5000/uL by microscopy.|12 months - period 1|Individual subject data from eligible clusters set defined as all participants randomized for which data on Symptomatic malaria episode, RDT-confirmed (SMRCs) was collected and census data was obtained as per protocol.||participants|||Number
832585|NCT01256658|Secondary|Number of Symptomatic Malaria Episode, RDT-confirmed, With Parasitemia ≥5000/μL (SMRC5000) in Asymptomatic Carriers at Any Time of Diagnosis (Per Cluster)|"Data is presented per cluster. Number of Symptomatic malaria episode, RDT-confirmed, with parasitemia ≥5000/μL (SMRC5000) in asymptomatic carriers by study arm from all inhabitants diagnosed at any time for asymptomatic carriers. Number of SMRC5000s is measured by Rapid diagnostic test (RDT) and later confirmed to have a parasite density ≥ 5000/uL by microscopy."|12 months - period 1|The number of units represents the number of clusters that include all participants randomized for which data on Symptomatic malaria episode, RDT-confirmed (SMRCs) were collected and census data were obtained as per protocol.||percentage of participants|Participants|Standard Deviation|Mean
832586|NCT01256658|Secondary|Number of Asymptomatic Carriers With Increase in Hemoglobin Levels by at Least 0.5 g/dL From Day 1 to Day 28 of Community Screening Campaign 1 (CSC1) in Infants and Children (>6 Months and <5 Years)- Cluster Data|"Data is presented per cluster. Cluster data of number of asymptomatic carriers with increase in hemoglobin levels by at least 0.5 g/dL from Day 1 to Day 28 of Community Screening Campaign 1 (CSC1) in infants and children (>6 months and <5 years) was measured by Hemoglobin levels based on microscopy reading.
Mean and Standard Deviation (SD) percent were measured indicating the mean and SD of percentages of cluster frequencies under the study arm for that particular category."|Day 1 to day 28 - period 1|The number of units represents the number of clusters that include all infants and children (>6 months and <5 years) randomized for which CSC1 was conducted, data was available, and census data were obtained as per protocol.||participants|Participants|Standard Deviation|Mean
832587|NCT01256658|Secondary|Number of Asymptomatic Carriers With Increase in Hemoglobin Levels by at Least 0.5 g/dL From Community Screening Campaign 1 (CSC1) Infants and Children (>6 Months and <5 Years)- Individual Data|Individual data of number of asymptomatic carriers with increase in hemoglobin levels by at least 0.5 g/dL from Day 1 to Day 28 from Community Screening Campaign 1 (CSC1) infants and children (>6 months and <5 years). Hemoglobin levels were measured using the HemoCue® rapid test. This test was performed with a drop of blood collected from the fingertip at Day 1 and at Day 28.|Day 1 to Day 28- period 1|Individual subject data from eligible clusters set defined as all infants and children (>6 months and <5 years) randomized for which CSC1 was conducted, data was available, and census data was obtained as per protocol.||participants|||Number
832627|NCT01250119|Primary|Percentage of Participants Who Tested Positive for EGFR Mutations|All participants newly diagnosed with recurrent or metastatic NSCLC were tested for EGFR exon 19 deletion or exon 21 mutations.|14 days|Diagnostic population; Only participants who were tested for EGFR mutations were included in the analysis.||percentage of participants|||Number
832683|NCT01250730|Primary|Maximum Plasma Concentration (Cmax) of Plasma Active Metabolite (PF-06260182)||0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose|||ng/mL||Standard Deviation|Geometric Mean
832588|NCT01256658|Secondary|Percentage of Microscopy-confirmed Gametocyte Carriers Treated With COA566 for Asymptomatic Carriers|Percentage of microscopy-confirmed gametocyte asymptomatic carriers treated with COA566 for asymptomatic carriers in Community Screening Campaign 1, 2 and 3 (CSC1, CSC2 and CSC3).|Day 1, day 7 and day 28 - period 1|Treated asymptomatic carriers from CSC1, CSC2 and CSC3 confirmed by microscopy and treated with study medication. Subjects are counted multiple times if diagnosed and treated more than once during the study. Subjects missing day 7 parasitemia data are excluded. Percentages are based on the number of subjects treated with any formulation.||percentage of participants|||Number
832589|NCT01256658|Secondary|Percentage of COA566-treated Microscopy-confirmed Asymptomatic Carriers at Community Screening Campaign 1, 2 and 3 (CSC1, CSC2 and CSC3) With Parasitological Cure Rate at Day 7|Percentage of participants with parasitological cure confirmed via microscopy at day 7 after treatment with COA566. This assessment was done on asymptomatic carriers from Community Screening Campaigns 1, 2 and 3 (CSC1, CSC2 and CSC3) from the intervention group only.|Day 7 of CSC1, CSC2 and CSC3 - period 1|Treated asymptomatic carriers from CSC1, CSC2 and CSC3 confirmed by microscopy and treated with study medication. Subjects are counted multiple times if diagnosed and treated more than once during the study. Subjects missing day 7 parasitemia data are excluded. Percentages are based on the number of subjects treated with any formulation.||percentage of participants|||Number
832590|NCT01256658|Secondary|Hemoglobin Level (g/dL) in Community Screening Campaign 1 (CSC1)/Day 1 and CSC4/Day 1 by Study Arm and Age Group (Per Cluster)|"Data is presented per cluster. Hemoglobin levels at Community Screening Campaign 1 and 4 (CSC1 and CSC4) on day 1 per age group (5-9 years, 10-14 years, and ≥15 years) in the intervention versus the control arm was measured using the HemoCue® rapid test. This test was performed using a drop of blood collected from the fingertip of each participant."|Day 1 (CSC1/day 1) and month 12 (CSC4/day 1) - period 1|The number of units represents the number of clusters that include all randomized participants (ages 5-9 years, 10-14 years, and ≥15 years) clusters for which CSC1 and CSC4 was conducted, data was available, and census data were obtained as per protocol.||g/dL|Participants|Standard Deviation|Mean
832591|NCT01256658|Secondary|Anemia Status Based on Community Screening Campaign 4 (CSC4)/Day 1 in Infants and Children (>6 Months and <5 Years)|Anemia status based on Community Screening Campaign 4 (CSC4/Day 1) in infants and children (>6 months and <5 years) was measured via hemoglobin levels using the HemoCue® rapid test. This test was performed using a drop of blood collected from the fingertip of each participant. The anemic status is defined as follows: hemoglobin (Hb) <5 g/dL = severe anemia, Hb 5 to <8 g/dL = moderate anemia, Hb 8 to <11 g/dL = mild anemia, Hb ≥11 g/dL = no anemia).|Month 12 (CSC4/day 1) - period 1|Individual subject data from eligible clusters set defined as all infants and children (>6 months and <5 years) randomized for which CSC4 was conducted, data was available, and census data was obtained as per protocol.||participants|||Number
832592|NCT01256658|Secondary|Anemia Status Based on Community Screening Campaign 1 (CSC1)/Day 1 in Infants and Children (>6 Months and <5 Years)|Anemia status based on Community Screening Campaign 1 (CSC1)/Day 1 in infants and children (>6 months and <5 years) was measured via hemoglobin levels using the HemoCue® rapid test. This test was performed using a drop of blood collected from the fingertip of each participant. The anemic status is defined as follows: hemoglobin (Hb) <5 g/dL = severe anemia, Hb 5 to <8 g/dL = moderate anemia, Hb 8 to <11 g/dL = mild anemia, Hb ≥11 g/dL = no anemia).|Day 1 (CSC1/day 1) - period 1|Individual subject data from eligible clusters set defined as all infants and children (>6 months and <5 years) randomized for which CSC1 was conducted, data was available, and census data were obtained as per protocol.||participants|||Number
832593|NCT01256658|Secondary|Change in Hemoglobin Level (g/dL) From Community Screening Campaign 1 (CSC1)/Day 1 to CSC1/Day 28 in Infants and Children (>6 Months and <5 Years) for Asymptomatic Carriers at CSC1|Change in hemoglobin level (g/dL) from Community Screening Campaign 1 (CSC1)/Day 1 to CSC1/Day 28 in infants and children (>6 Months and <5 Years) for asymptomatic carriers at CSC1 was measured via hemoglobin levels using the HemoCue® rapid test. This test was performed using a drop of blood collected from the fingertip of each participant. The anemic status is defined as follows: hemoglobin (Hb) <5 g/dL = severe anemia, Hb 5 to <8 g/dL = moderate anemia, Hb 8 to <11 g/dL = mild anemia, Hb ≥11 g/dL = no anemia).|Day 1 and day 28 - period 1|Individual subject data from eligible clusters set defined as all infants and children (>6 months and <5 years) randomized for which CSC1 was conducted, data was available, and census data were obtained as per protocol.||g/dL||Standard Deviation|Mean
832594|NCT01256658|Secondary|Number of Microscopy and qRT-PCR-confirmed Gametocyte Carriers at Community Screening Campaign 4 (CSC4)|Number of gametocyte carriers at Community Screening Campaign 4 (CSC4) was measured via microscopy and confirmed using Quantitative Reverse Transcription PCR (qRT-PCR) at day 1 of CSC4.|Month 12 (CSC4/day 1) - period 1|Individual subject data from eligible clusters set defined as all randomized participants for which CSC4 was conducted, data was available, and census data was obtained as per protocol.||participants|||Number
832595|NCT01256658|Secondary|Mean Number of Microscopy-confirmed Gametocyte Carriers at Day 1 of Community Screening Campaign 1,2,3,4 (CSC1, CSC2, CSC3 and CSC4) (Per Cluster)|"Data is presented per cluster. Mean number of gametocyte carriers at Day 1 for Community Screening Campaign 1,2,3,4 (CSC1, CSC2, CSC3 and CSC4) was measured using gametocyte assessments (prevalence and density) via microscopy.
Mean measured in this analysis is the mean percent indicating the mean of percentages of cluster frequencies under the study arm for that particular category."|12 months - period 1|Eligible clusters set consisted of all randomized participants for which CSCs 1, 2, 3 and 4 were conducted, data was available, and census data were obtained as per protocol.||participants|Participants|Standard Deviation|Mean
832596|NCT01256658|Secondary|Mean of Microscopy-confirmed Asymptomatic Carriers From Community Screening Campaigns 1, 2, 3 and 4 (CSC1, CSC2, CSC3 and CSC4) (Per Cluster)|"Data is presented per cluster. Mean number of asymptomatic carriers from Community Screening Campaigns 1, 2, 3 and 4 (CSC1, CSC2, CSC3 and CSC4) was measured by confirmed positive microscopy for P. falciparum asexual forms in participants with absence of clinical signs and symptoms of malaria.
Mean measured in this analysis is the mean percent indicting the mean of percentages of cluster frequencies under the study arm for that particular category."|12 months - period 1|The number of units represents the number of clusters that include all randomized participants for which CSC 1, 2 3 and 4 was conducted, data was available, and census data were obtained as per protocol.||participants|Participants|Standard Deviation|Mean
832597|NCT01256658|Secondary|Number of Participants (Infants and Children (> 6 Months and < 5 Years)) With Hospitalizations, Severe Malaria Episodes or Death Post Community Screening Campaign (CSC)|Total number of participants (infants and children (> 6 months and < 5 years)) with hospitalizations, severe malaria episodes or death after Community Screening Campaign (CSC) was assessed.|12 months - period 1|Safety analyzable carriers set consisted of all infants and children (> 6 months and < 5 years)) from intervention clusters confirmed positive for P. falciparum asexual forms at any CSC or when migrating into the cluster, who in the absence of clinical signs and symptoms received at least one dose of COA566 for the diagnosed asymptomatic infection.||participants|||Number
832598|NCT01256658|Secondary|Number of Participants With Hospitalizations, Severe Malaria Episodes or Death Post Community Screening Campaign (CSC)|Total number of participants (all ages) with hospitalizations, severe malaria episodes or death after Community Screening Campaign (CSC) was assessed.|12 months - period 1|Safety analyzable asymptomatic carriers set consisted of all consenting inhabitants from intervention clusters confirmed positive by RDT for P. falciparum asexual forms at any CSC or when migrating into the cluster, in the absence of clinical signs and symptoms who received at least one dose of COA566 to treat the diagnosed asymptomatic infection.||participants|||Number
832599|NCT01256658|Secondary|Number of Symptomatic Malaria Episode, RDT-confirmed, With Parasitemia ≥5000/μL (SMRC5000s) Per Person-year in Post Community Screening Campaign (CSC)|"Number of Symptomatic malaria episode, RDT-confirmed, with parasitemia ≥5000/μL (SMRC5000s) per person-year in post Community Screening Campaign (CSC), by study arm (individual level data) was detected by Rapid Diagnostic Test (RDT) (using a blood sample from each participant) and later confirmed to have a parasite density ≥5000/uL by microscopy.
Number of SMRC5000: sum of all SMRC5000 for all subjects in post CSC. Person-year observed: sum of duration (in days) in post CSC for all subjects present in study /365.25.
Number of SMRC5000 per person-year = number of SMRC5000/person-year observed."|12 months - period 1|Individual subject data from eligible clusters set defined as all randomized participants for which CSCs 1, 2, 3 and 4 were conducted, data was available, and census data were obtained as per protocol.||SMRC5000 per person-year|||Number
832600|NCT01256658|Secondary|Change in Hemoglobin Level (g/dL) From Community Screening Campaign 1(CSC1)/Day 1 to Community Screening Campaign 4 (CSC4)/Day 1 (Per Cluster)|"Data is presented per cluster. Comparison of hemoglobin level (g/dL) from Community Screening Campaign 1 (CSC1)/Day 1 to Community Screening Campaign 4 (CSC4)/Day 1 in infants and children (>6 months and <5 years) by study arm was measured using the HemoCue® rapid test. This test was performed using a drop of blood collected from the fingertip of each participant."|Day 1 (CSC1/day 1) and month 12 (CSC4/day 1) - period 1|The number of units represents the number of clusters that include all infants and children (>6 months and <5 years) randomized participants for which CSCs 1 and 4 were conducted, data was available, and census data were obtained as per protocol.||g/dL|Participants|Standard Deviation|Mean
832601|NCT01256658|Secondary|Microscopy Confirmed Asymptomatic Carriers of P. Falciparum at Community Screening Campaign 4 (CSC4) (Per Cluster)|"Data is presented per cluster. Microscopy confirmation of asymptomatic carriers of P. falciparum at Community Screening Campaign 4 (CSC4) was conducted at month 12. Blood films were histologically treated and examined microscopically. When it was ascertained that P. falciparum was present, a count of the asexual forms against leukocytes was made using a tally counter."|Month 12 - period 1|The number of units represents the number of clusters that include all randomized participants for which CSC4 was conducted, data was available, and census data was obtained as per protocol.||participants|Participants|Standard Error|Mean
832602|NCT01256658|Secondary|Microscopy-confirmed Gametocyte Carriers at Community Screening Campaign 4 (CSC4) (Per Cluster)|"Data is presented per cluster. Microscopy confirmed gametocyte carriers at Community Screening Campaign 4(CSC4) were assessed via microscopy at month 12 of period 1. Blood films were histologically treated and examined microscopically."|Month 12 - period 1|The number of units represents the number of clusters that include all randomized participants for which CSC4 was conducted, data was available, and census data were obtained as per protocol.||participants|Participants|Standard Error|Mean
832603|NCT01256658|Primary|Change in Hemoglobin Level (g/dL) in Asymptomatic Carriers >6 Months of Age (Per Cluster)|"Data is presented per cluster. Change in hemoglobin levels from day 1 to day 28 was measured using the HemoCue® rapid test. This test was performed using a drop of blood collected from the fingertip of each asymptomatic carrier from Community Screening Campaign 1 (CSC1), > 6 months of age, at day 1 and at day 28."|Day 1 and day 28 of period 1|The number of units represents the number of clusters that include all randomized, > 6 months of age participants for which CSC1 was conducted, data was available and census data were obtained as per protocol.||g/dL|Participants|Standard Deviation|Mean
832604|NCT01256658|Primary|Number of Symptomatic Malaria Episode, RDT-confirmed, With Parasitemia ≥5000/μL (SMRC5000s) Per Person-year in Infants and Children (<5 Years) in Post Community Screening Campaign (CSC) at Month 12 (Per Cluster)|"Data is presented per cluster. Number of Symptomatic malaria episode, RDT-confirmed, with parasitemia ≥5000/μL (SMRC5000s) per person-year in infants and children (<5 years) in post Community Screening Campaign (CSC) at month 12 was detected by Rapid Diagnostic Test (RDT) (using a blood sample from each participant) and later confirmed to have a parasite density ≥5000/uL by microscopy.
Number of SMRC5000: sum of all SMRC5000 for all infants and children (<5 years) in post CSC.
Person-year observed: sum of duration (in days) for all infants and children (<5 years) in post CSC present in study /365.25.
Number of SMRC5000 per person-year = number of SMRC5000/person-year observed."|Month 12 of period 1|The number of units represents the number of clusters that include all randomized infants and children (<5 years) for which CSCs 1, 2, and 3 were conducted, data was available, and census data were obtained as per protocol.||SMRC5000 per person-year|Participants|Standard Deviation|Mean
832605|NCT01256684|Secondary|Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color|To evaluate the aspect of the mucosa and the local tolerance to DHEA suppositories, the vaginal color (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was then analyzed using the values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.||units on a scale||Standard Error|Mean
832606|NCT01256684|Secondary|Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness|To evaluate the aspect of the mucosa and the local tolerance to DHEA suppositories, the vaginal epithelial surface thickness (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was then analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.||units on a scale||Standard Error|Mean
832607|NCT01256684|Secondary|Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity|To evaluate the aspect of the mucosa and the local tolerance to DHEA suppositories, the vaginal epithelial integrity (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was then analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.||units on a scale||Standard Error|Mean
832608|NCT01256684|Secondary|Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions|To evaluate the aspect of the mucosa and the local tolerance to DHEA suppositories, the vaginal secretions (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy were then analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.||units on a scale||Standard Error|Mean
832609|NCT01256684|Secondary|Change From Baseline to Week 12 in Severity of Vaginal Dryness|The severity of vaginal dryness was evaluated by a questionnaire filled out by women. The severity of vaginal dryness recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Efficacy analyses on vaginal dryness were performed on a sub-group of the Intent to Treat (ITT) population (defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria) who have self-identified moderate to severe vaginal dryness at Baseline.||units on a scale||Standard Error|Mean
832610|NCT01256684|Primary|Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Dyspareunia|The severity of dyspareunia was evaluated by a questionnaire filled out by women. The severity of dyspareunia recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.||units on a scale||Standard Error|Mean
832611|NCT01256684|Primary|Change From Baseline to Week 12 in Vaginal pH|A pH strip fixed on an Ayre spatula (or equivalent) was applied directly to the lateral wall of the vagina. The change in color of the pH indicator strip was compared to the color chart for pH evaluation. The corresponding pH value (with one decimal) was recorded. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.||units on a scale||Standard Error|Mean
832612|NCT01256684|Primary|Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear|The percentage of superficial cell was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including the basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Efficacy analyses were performed primarily on the Intent-to-Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.||Percentage of superficial cells||Standard Error|Mean
832613|NCT01256684|Primary|Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear|The percentage of parabasal cell was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including the basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.||Percentage of parabasal cells||Standard Error|Mean
832614|NCT01250002|Secondary|Opioid Consumption (Morphine Equivalents)|opioid consumption (morphine equivalents)post operatively|24 hours|||mg||Full Range|Median
832615|NCT01250002|Primary|Quality of Recovery 40 Score|Quality of recovery 40 score on the day after surgery. Scale ranges from a low of 40 (poor recovery) to a high of 200 (good recovery).|24 hours post surgery|Intent to treat.||units on a scale||Full Range|Median
832616|NCT01250054|Primary|Overall Vision|Overall vision, as interpreted by the participant and recorded by the investigator as a single, retrospective evaluation of one week’s wear time. Overall vision was measured on a 10-point scale, with 1 being worst and 10 being best.|One week of wear|Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses.||units on a scale||Standard Deviation|Mean
833441|NCT01258049|Secondary|Parasite Clearance Time (PCT) [MITT Population]|Parasite clearance time (PCT). Time in hours from the initiation of therapy until the first of two successive parasite negative smears (zero parasite counts) are obtained|28 days after start of treatment|||hours||Standard Deviation|Mean
832617|NCT01250119|Secondary|Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D|The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The participants were required to rate their pain as the following categories: Category 1. I am not anxious or depressed; Category 2. I am moderately anxious or depressed; Category 3.I am extremely anxious or depressed.|Baseline (Visit 1), Days 10 to 14 (Visit 2), Day 1 of every 6 weeks until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months|ITT population; n = number of participants analyzed for the given parameter at the specified visit.||percentage of participants|||Number
832618|NCT01250119|Secondary|Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D|The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The participants were required to rate their pain as the following categories: Category 1. I have no pain or discomfort; Category 2. I have moderate pain or discomfort; Category 3. I have extreme pain or discomfort.|Baseline (Visit 1), Days 10 to 14 (Visit 2), Day 1 of every 6 weeks until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months|ITT population; n = number of participants analyzed for the given parameter at the specified visit.||percentage of participants|||Number
832619|NCT01250119|Secondary|Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D|The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The participants were required to rate their ability to perform usual activities as the following categories: Category 1. I have no problems with performing my usual activities; Category 2. I have some problems with performing my usual activities; Category 3. I am unable to perform my usual activities.|Baseline (Visit 1), Days 10 to 14 (Visit 2), Day 1 of every 6 weeks until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months|ITT population; n = number of participants analyzed for the given parameter at the specified visit.||percentage of participants|||Number
832620|NCT01250119|Secondary|Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D|The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The participants were required to rate their self-care as the following categories: Category 1. I have no problems with self-care; Category 2. I have some problems washing or dressing myself; Category 3. I am unable to wash or dress myself.|Baseline (Visit 1), Days 10 to 14 (Visit 2), Day 1 of every 6 weeks until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months|ITT population; n = number of participants analyzed for the given parameter at the specified visit.||percentage of participants|||Number
832621|NCT01250119|Secondary|Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D|The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The participants were required to rate their mobility as the following categories: Category 1. I have no problems in walking about; Category 2. I have some problems in walking about; Category 3. I am confined to bed.|Baseline (Visit 1), Days 10 to 14 (Visit 2), Day 1 of every 6 weeks until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months|ITT population; n = number of participants analyzed at for the given parameter at the specified visit.||percentage of participants|||Number
832622|NCT01250119|Secondary|Quality of Life Assessment Using EuroQol(EQ) 5D Visual Analog Score (VAS) Instrument|The EQ-5D contains a descriptive system that measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The EQ-5D also contains a visual analog scale (EQ-VAS), which records the respondent's self-rated health status on a vertical graduated visual analog scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). A negative change indicates improvement.|Screening, Baseline and Final or Withdrawal Visit up to 34 months|ITT population; number (n) = number of participants analyzed for the given parameter at the specified visit.||mm||Standard Deviation|Mean
832623|NCT01250119|Secondary|Survival Time in Months|Duration of time in months from Screening until Death due to any cause.|Baseline, Day 1 of each 6-week visit starting from Visit 3 until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months|ITT population||months||95% Confidence Interval|Median
832624|NCT01250119|Secondary|Probability of Being Alive and Free of Progression by Timepoint|Progression Free Survival (PFS) was defined as the interval (number of days) from the trial treatment start date to the earlier of the date of the first tumor response assessment of PD or the date of death by any cause. Participants who experienced neither of these events or who were lost to followup at the time of the analysis were censored at date of last contact. PFS was summarized according to the Kaplan-Meier method.|Months 0, 3, 6, 9, 12, 15, and 18|ITT population||probability of being alive||95% Confidence Interval|Number
832625|NCT01250119|Primary|Percentage of Participants With EGFR Mutations by Subgroup|Incidence of EGFR mutations were summarized with respect to different subgroups as follows: (1) equals (=) Histopathology, (2) = Stage of disease, (3) = Age at consent, (4) = Gender, (5) = Race, (6) = Smoking history.|14 Days|Only participants with a valid EGFR mutations test result were included in the analysis.||percentage of participants|||Number
832626|NCT01250119|Secondary|Percentage of Participants With a Response by Best Objective Tumor Response|Best objective response was defined as the best response recorded from the start of treatment until disease progression/recurrence. Tumor response was assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1”. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 millimeters (mm). Partial Response (PR): At least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this may include the baseline sum). The sum must also demonstrate an absolute increase of at least 5 mm. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|Screening, Day 1 of each 6 week visit starting from Visit 3 until PD, Death, Unacceptable Toxicity or Withdrawal of Consent up to 34 months|Intention-to-treat (ITT) population: All participants in the target population who were eligible for treatment and who actually received one dose of treatment.||percentage of participants|||Number
833982|NCT01263496|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 28).|The change between the value of fasting plasma glucose collected at week 28 and fasting plasma glucose collected at baseline.|Baseline and Week 28.|Values are Summary Statistics.||mg/dL||Standard Deviation|Mean
832628|NCT01250145|Secondary|Part B - Patch Adhesion Score|Number of patches with adhesion score. Score 0 = ≥90% adhered (essentially no lift off the skin); Score 1= ≥75% to <90% adhered (some edges only lifting off the skin); Score 2 = ≥50% to <75% adhered (less than half of the patch lifting off the skin); Score 3 = >0% to <50% adhered but not detached (more than half of the patch lifting off the skin without falling off); Score 4 = 0% adhered - patch detached (patch completely off the skin).|Days 1 - 19 and 34 - 37|All randomized participants who received a patch.||patches with adhesive score|Participants||Number
832629|NCT01250145|Primary|Part B - Skin Irritation and Sensitization by Draize Score|Number of evaluation points (patches) showing defined Draize score. Erythema and edema were used to determine skin irritation and sensitization. Score 0 = No Erythema/Edema; Score 1 = Very slight Erythema/Edema (barely perceptible); Score 2 = Well defined Erythema/Edema (edges of area well defined by definite raising); Score 3 = Moderate to Severe Erythema/Edema (raised approximately 1 mm); Score 4 = Severe Edema (raised more than 1 mm and extending beyond area of exposure).|Days 1 - 19 and 34 - 37|All participants who entered the study and received patches are included in the analysis.||patches with Draize scores|Participants||Number
832630|NCT01250145|Secondary|Part A - Patch Adhesion Score|Number of patches with adhesion score. Score 0 = ≥90% adhered (essentially no lift off the skin); Score 1= ≥75% to <90% adhered (some edges only lifting off the skin); Score 2 = ≥50% to <75% adhered (less than half of the patch lifting off the skin); Score 3 = >0% to <50% adhered but not detached (more than half of the patch lifting off the skin without falling off); Score 4 = 0% adhered - patch detached (patch completely off the skin).|Day 1 through Day 22|All randomized participants who received a patch.||patches with adhesive score|Participants||Number
832631|NCT01250145|Primary|Part A - Cumulative Skin Irritation by Draize Score|Number of evaluation points (patches) showing defined Draize score. Erythema and edema were used to determine skin irritation. Score 0 = No Erythema/Edema; Score 1 = Very slight Erythema/Edema (barely perceptible); Score 2 = Well defined Erythema/Edema (edges of area well defined by definite raising); Score 3 = Moderate to Severe Erythema/Edema (raised approximately 1 millimeter [mm]).|Day 1 through Day 22|All participants who entered the study and received patches are included in the analysis.||patches with Draize scores|Participants||Number
832632|NCT01250171|Secondary|Change From Baseline in Best Corrected Visual Acuity at Weeks 1, 4, and 8|Best corrected visual acuity (BCVA) was assessed in the study eye. BCVA measurements were taken in a standing position using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at an initial testing distance specific to the test charts. The BCVA score is the number of letters read correctly by the patient. A decrease in the BCVA score indicates a worsening of vision. A positive change score indicates improvement.|Baseline to Weeks 1, 4, and 8|All patient population: All randomized patients that received 1 full dose of a study drug per protocol. Two patients were not included in the all patient population (1 in each drug group) as they were not dosed per protocol or they did not receive the full dose of the assigned treatment.||Units on a scale||Standard Deviation|Mean
832633|NCT01250171|Secondary|Desire for Artificial Tear Use at Day 1 and Weeks 1, 4, and 8|Patients were instructed to record each occurrence of a desire for topical lubricant use in a patient diary. The percentage of patients in each of 6 categories (0-5, 6-10, 11-15, 16-20, 21-25, > 25 times) indicating the number of times a patient records a desire for artificial tear use per day was calculated at each time point. The percentage was calculated using the number of patients with any reported data on that day in the respective treatment group as the denominator.|Day 1 and Weeks 1, 4, and 8|All patient population: All randomized patients that received 1 full dose of a study drug per protocol. Two patients were not included in the all patient population (1 in each drug group) as they were not dosed per protocol or they did not receive the full dose of the assigned treatment.||Percentage of patients|||Number
832634|NCT01250171|Secondary|Change From Baseline in the Ocular Surface Disease Index (OSDI) at Weeks 1, 4, and 8|The OSDI is an instrument for measuring dry eye disease severity and effect on vision-related functions. Patients were asked a series of 12 questions; patients responded to the questions in regard to both eyes. Responses ranged from 0=None of the time to 4=All of the time. OSDI was calculated as the sum of the 12 question scores x 25/number of questions answered. The total score ranged from 0-100. A higher score indicates drier eyes. A negative change score indicates improvement in dryness.|Baseline to Weeks 1, 4, and 8|All patient population: All randomized patients that received 1 full dose of a study drug per protocol. Two patients were not included in the all patient population (1 in each drug group) as they were not dosed per protocol or they did not receive the full dose of the assigned treatment.||Units on a scale||Full Range|Mean
832635|NCT01250171|Secondary|Change From Baseline on the Conjunctival Redness Scale (Ora) at Weeks 1, 4, and 8|Conjunctival redness was measured in the study eye at each visit by a masked evaluator. The evaluator compared the patient’s study eye with a set of 5 reference photos showing a normal eye and eyes with various degrees of redness. Redness was scored on a scale of 0-5 with a white normal eye = 0 and an eye with the most redness = 5. A higher score indicates more redness. A negative change score indicates improvement in redness.|Baseline to Weeks 1, 4, and 8|All patient population: All randomized patients that received 1 full dose of a study drug per protocol. Two patients were not included in the all patient population (1 in each drug group) as they were not dosed per protocol or they did not receive the full dose of the assigned treatment.||Units on a scale||Full Range|Mean
832636|NCT01250171|Secondary|Change From Baseline in Tear Film Breakup Time at Weeks 1, 4, and 8|Tear film breakup time was defined as the time of last blink to the appearance of the first growing micelle after instilling 5 μl of non-preserved 2% sodium fluorescein into the lower palpebral conjunctiva of the study eye. Measurement was repeated 3 times and a mean tear film breakup time calculated. A lower score indicates a drier eye. A positive change score indicates improvement in dryness.|Baseline to Weeks 1, 4, and 8|All patient population: All randomized patients that received 1 full dose of a study drug per protocol. Two patients were not included in the all patient population (1 in each drug group) as they were not dosed per protocol or they did not receive the full dose of the assigned treatment.||Seconds||Full Range|Mean
832684|NCT01250730|Primary|Area Under the Plasma Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Plasma Active Metabolite (PF-06260182)|AUClast of crizotinib is estimated from the crizotinib concentration. It is obtained from Linear/Log trapezoidal method.|0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose|||ng*hr/mL||Standard Deviation|Geometric Mean
832637|NCT01250171|Secondary|Change From Baseline on the Schirmer Test at Weeks 1, 4, and 8|The Schirmer test measures the production of tears. A small strip of filter paper is placed inside the lower eyelid (conjunctival sac) of each eye and the eyes are kept closed for 5 minutes. The paper is removed and the length of paper that is wet is measured as an index of tear production. The amount of tear production in the study eye was ranked on a 4 point scale: 0=Normal (≥ 15 mm wetting of the paper), 1=Mild (14-9 mm wetting of the paper), 2=Moderate (8-4 mm wetting of the paper), and 3=Severe (< 4 mm wetting of the paper). A higher score indicates a drier eye. A negative change score indicates improvement in dryness.|Baseline to Weeks 1, 4, and 8|All patient population: All randomized patients that received 1 full dose of a study drug per protocol. Two patients were not included in the all patient population (1 in each drug group) as they were not dosed per protocol or they did not receive the full dose of the assigned treatment.||Units on a scale||Full Range|Mean
832638|NCT01250171|Secondary|Change From Baseline on the Ora Corneal Staining Scale at Weeks 1, 4, and 8|Corneal staining was done with 2% sodium fluorescein instilled into the lower palpebral conjunctiva of the study eye. Staining was assessed in 3 regions (inferior, superior, and central) of the cornea and rated on a scale of 0 (no staining) to 4 (confluent staining). A mean of the 3 zones was calculated. A higher score indicates a drier eye. A negative change score indicates improvement in dryness.|Baseline to Weeks 1, 4, and 8|All patient population: All randomized patients that received 1 full dose of a study drug per protocol. Two patients were not included in the all patient population (1 in each drug group) as they were not dosed per protocol or they did not receive the full dose of the assigned treatment.||Units on a scale||Standard Deviation|Mean
832639|NCT01250171|Primary|Change From Baseline on the National Eye Institute Corneal Staining Scale (NEI-CSS) at Week 4|Corneal staining was done with 2% sodium fluorescein instilled into the lower palpebral conjunctiva of each eye. Staining was assessed in 5 zones of the cornea (central plus 4 quadrants) and rated on a scale of 0 (no staining) to 3 (severe, confluent staining). A mean of the 5 zones for the study eye was calculated. A higher score indicates a drier eye. A negative change score indicates improvement in dryness.|Baseline to Week 4|All patient population: All randomized patients that received 1 full dose of a study drug per protocol. Two patients were not included in the all patient population (1 in each drug group) as they were not dosed per protocol or they did not receive the full dose of the assigned treatment.||Units on a scale||Standard Deviation|Mean
832640|NCT01250184|Secondary|Quality of Life SF-36|The SF-36 consists of 36 items addressing the patient's perception of their quality of life (QoL) in the following eight domains: physical function (PF), role limitations due to physical problems (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role limitations due to emotional problems (RE), and mental health (MH), and one item change in health. Sub-scale scores range from 0 to 100, with 100 as the best, most positive QoL in that area and 0 is the worst. There is a total scale score, all subscales range from 0 to 100. This scale was validated in Colombia.|12 weeks|||units on a scale||Standard Deviation|Mean
832641|NCT01250184|Secondary|PHQ 9 Function Measured With the Hand Back and Hand Mouth Maneuvers. Complications and Adverse Reactions Need for Rescue Medication|The PHQ-9 was developed from the Primary Care Evaluation of Mental Disorders. The self-report instrument asks individuals how much they had been bothered by any of the nine problems over the prior two weeks. Items are scored from 0 (not at all) to 3 (nearly every day). Items are summed and the total score (from 0 to 27) represents the severity of depressive symptoms. 0 - 4 None-minimal None, 5 - 9 Mild, 10 - 14 Moderate, 15 - 19 Moderately Severe, 20 - 27 Severe|12 weeks|||units on a scale||Standard Deviation|Mean
832642|NCT01250184|Primary|Visual Analogue Scale|VAS with a score of 0-100, where 100 is the value representing the highest degree of pain and 0 the lowest. Successful treatment was defined as a reduction in pain of at least 20% of the previous score on the VAS after 4 weeks of the initial evaluation, or 14 mm on the VAS; this scale is a reliable pain assessment measure that has been validated previously|12 weeks|"Was calculated with the software Sample Size from Javeriana University, was taken into account an error type I of 0.05 and error type II of 0.2, number of measurements before randomization = 1, after performing scrambling = 2, correlation between measurements of 0.6, clinically important difference of 0.35, for a total number of = 45 each"||units on a scale||Standard Deviation|Mean
832643|NCT01250184|Secondary|Quality of Life SF-36|The SF-36 consists of 36 items addressing the patient's perception of their quality of life (QoL) in the following eight domains: physical function (PF), role limitations due to physical problems (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role limitations due to emotional problems (RE), and mental health (MH), and one item change in health. Sub-scale scores range from 0 to 100, with 100 as the best, most positive QoL in that area and 0 is the worst. There is a total scale score, all subscales range from 0 to 100. This scale was validated in Colombia.|4 weeks|||units on a scale||Standard Deviation|Mean
832644|NCT01250184|Secondary|PHQ 9 Function Measured With the Hand Back and Hand Mouth Maneuvers. Complications and Adverse Reactions Need for Rescue Medication|The PHQ-9 was developed from the Primary Care Evaluation of Mental Disorders. The self-report instrument asks individuals how much they had been bothered by any of the nine problems over the prior two weeks. Items are scored from 0 (not at all) to 3 (nearly every day). Items are summed and the total score (from 0 to 27) represents the severity of depressive symptoms. 0 - 4 None-minimal None, 5 - 9 Mild, 10 - 14 Moderate, 15 - 19 Moderately Severe, 20 - 27 Severe|4 weeks|||units on a scale||Standard Deviation|Mean
832645|NCT01250184|Primary|Visual Analogue Scale|VAS with a score of 0-100, where 100 is the value representing the highest degree of pain and 0 the lowest. Successful treatment was defined as a reduction in pain of at least 20% of the previous score on the VAS after 4 weeks of the initial evaluation, or 14 mm on the VAS; this scale is a reliable pain assessment measure that has been validated previously|4 weeks|"Was calculated with the software Sample Size from Javeriana University, was taken into account an error type I of 0.05 and error type II of 0.2, number of measurements before randomization = 1, after performing scrambling = 2, correlation between measurements of 0.6, clinically important difference of 0.35, for a total number of = 45 each"||units on a scale||Standard Deviation|Mean
832729|NCT01250834|Secondary|Pharmacokinetics of Ortho-Hydroxyatorvastatin: Area Under the Curve (AUC)|This measure is based on the pharmacokinetic area under the ortho-hydroxyatorvastatin concentration-time curve from time 0 to infinity.|Pre-dose to 56 hours post-dose|All randomized participants who received at least 1 dose of study drug and have evaluable pharmacokinetic (PK) data.||nanogram*hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
832646|NCT01250379|Primary|Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 24|Second­line PFS was defined as the time from randomization to PD or death due to any cause during their second­line of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second­line PD or death were censored at the date of last tumor assessment where non­progression was documented.|Month 24|ITT population||percentage of participants||95% Confidence Interval|Number
832647|NCT01250379|Primary|Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 18|Second­line PFS was defined as the time from randomization to PD or death due to any cause during their secondline of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second­line PD or death were censored at the date of last tumor assessment where non­progression was documented.|Month 18|ITT population||percentage of participants||95% Confidence Interval|Number
832648|NCT01250379|Primary|Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 12|Second­line PFS was defined as the time from randomization to PD or death due to any cause during their second­line of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without secondline PD or death were censored at the date of last tumor assessment where non­progression was documented.|Month 12|ITT population||percentage of participants||95% Confidence Interval|Number
832649|NCT01250379|Secondary|Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)|"The FACT-B is composed of 5 multi-item sections where participants responded to questions assessing symptoms (scale: 0-4; 0=not at all and 4=very much), as follows: PWB (7 items, total score 0-28), SWB (7 items, total score 0-28), EWB (6 items, total score 0-24), FWB (7 items, total score 0-28); and breast cancer score based on the additional concerns section of FACT-B (10 items, total score 0-40). The FACT-B TOI score=sum of PWB, FWB, and breast cancer score subscale scores (total score 0-96). The FACT-G total score=sum of PWB, SWB, EWB, and FWB subscales scores (total score 0-108). The FACT-B total score=sum of PWB, SWB, EWB, FWB, and breast cancer score subscale scores (total score 0-148). In all cases a higher value indicated a better perceived quality of life."|Baseline (≤28 days after randomization), every 8-9 weeks thereafter until second-line PD (up to approximately 3 years)|ITT population. Here, Number of participants analyzed = participants evaluable for this outcome measure and n=number of participants who completed the assessment at the specified timepoint.||score on a scale||95% Confidence Interval|Mean
832650|NCT01250379|Secondary|Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)|"The Functional Assessment of Cancer Therapy-Breast (FACT-B) is composed of 5 multi-item sections where participants responded to questions assessing symptoms (scale: 0-4; 0=not at all and 4=very much), as follows: physical well-being (PWB) (7 items, total score 0-28), social/family well-being (SWB) (7 items, total score 0-28), emotional well-being (EWB) (6 items, total score 0-24), functional well-being (FWB) (7 items, total score 0-28); and breast cancer score based on the additional concerns section of FACT-B (10 items, total score 0-40). The FACT-B Trial Outcomes Index (TOI) score=sum of PWB, FWB, and breast cancer score subscale scores (total score 0-96). The Functional Assessment of Cancer Therapy-General (FACT-G) total score=sum of PWB, SWB, EWB, and FWB subscales scores (total score 0-108). The FACT-B total score=sum of PWB, SWB, EWB, FWB, and breast cancer score subscales scores (total score 0-148). In all cases a higher value indicated a better perceived quality of life."|Baseline (≤28 days after randomization), every 8-9 weeks thereafter until second-line PD (up to approximately 3 years)|ITT population. Here, Number of participants analyzed = participants evaluable for this outcome measure and n=number of participants who completed the questionnaire at the specified timepoints.||score on a scale||95% Confidence Interval|Mean
832651|NCT01250379|Secondary|Change From Baseline in VAS Scores (Data Cutoff 20 December 2013)|The participant was asked to rate their overall health on a 0-100 mm vertical scale, where the lowest endpoint = 0 (labeled as worst imaginable health state) and the highest endpoint =100 (labeled as the best imaginable health state). The participant marked the line corresponding to their assessment and the distance from the bottom was measured in millimeters. A negative value indicated a worsening of perceived quality of life and a positive value indicated an improvement of perceived quality of life.|Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years)|ITT population. Here, Number of participants analyzed = participants evaluable for this outcome measure and n=number of participants who completed the assessment at the specified timepoint.||mm||95% Confidence Interval|Mean
832652|NCT01250379|Secondary|Quality of Life Assessed Using the EQ-5D Visual Analogue Scale (VAS) Scores (Data Cutoff 20 December 2013)|The participant was asked to rate their overall health on a 0-100 millimeter (mm) vertical scale, where the lowest endpoint=0 (labeled as worst imaginable health state) and the highest endpoint =100 (labeled as the best imaginable health state). The participant marked the line corresponding to their assessment and the distance from the bottom was measured in millimeters. A higher value indicated a better health state.|Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years)|ITT population; n=number of participants who completed the assessment at the specified timepoint.||mm||95% Confidence Interval|Mean
832662|NCT01250379|Secondary|Second- and Third-Line PFS|The median time, in months, from randomization to second-line and third-line PFS event. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without third-line PD or death were censored at the date of last tumor assessment where non-progression was documented.|Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 4 years|ITT population||months||95% Confidence Interval|Median
832653|NCT01250379|Secondary|Change From Baseline in EQ-5D Index Scores (Data Cutoff 20 December 2013)|"The EQ-5D is composed of 5 single-item measures where participants responded to questions assessing health status by responding with either no problems, some problems, or extreme problems in the following categories: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Based on large population surveys, an algorithm was used to combine the responses to each of these 5 measures into 1 single EQ-5D index score ranging from -0.59 (extreme problems) to +1 (no problems) where a negative value indicated a worsening of perceived quality of life and a positive value indicated an improvement of perceived quality of life."|Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years)|ITT population. Here, Number of participants analyzed = participants evaluable for this outcome measure and n=number of participants who completed the assessment at the specified timepoint.||score on a scale||95% Confidence Interval|Mean
832654|NCT01250379|Secondary|Quality of Life Assessed As an Index Score Using the EQ-5D (Data Cutoff 20 December 2013)|The EQ-5D is composed of 5 single-item measures where participants responded to questions assessing health status by responding with either “no problems”, “some problems”, or “extreme problems” in the following categories: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Based on large population surveys, an algorithm was used to combine the responses to each of these 5 measures into 1 single EQ-5D index score ranging from -0.59 (extreme problems) to +1 (no problems).|Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years)|ITT population. Here, Number of participants analyzed = participants evaluable for this outcome measure and n=number of participants who completed the assessment at the specified timepoint||score on a scale||95% Confidence Interval|Mean
832655|NCT01250379|Secondary|Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013)|The EQ-5D is composed of 5 single-item measures where participants responded to questions assessing health status by responding with either “no problems”, “some problems”, or “extreme problems” in the following categories: mobility (M) (“no problems”=“I have no problems in walking about” to “extreme problems”=“I am confined to bed”), self-care (SC) (“no problems”=“I have no problems with self-care” to “extreme problems”=”I am unable to wash or dress myself”), usual activities (UA) (“no problems”=“I have no problems performing my usual activities” to “extreme problems”=“I am unable to perform my usual activities”), pain/discomfort (P/D) (“no problems”=“I have no pain or discomfort” to “extreme problems”=“I have extreme pain or discomfort”), and anxiety/depression (A/D) (“no problems”=“I am not anxious or depressed” to “extreme problems”=‘I am extremely anxious or depressed”).|Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years)|ITT population. Here, Number of participants analyzed = participants evaluable for this outcome measure and n=number of participants completing the questionnaires at the corresponding timepoint.||percentage of participants|||Number
832656|NCT01250379|Secondary|Percentage of Participants Estimated to be Surviving at Months 6, 12, 18, and 24|OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause.|Months 6, 12, 18, and 24|ITT population||percentage of participants||95% Confidence Interval|Number
832657|NCT01250379|Secondary|Overall Survival (OS)|OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Participants who had not died were censored at the date the patient was last known to be alive.|Baseline until death (up to approximately 4 years)|ITT population||months||95% Confidence Interval|Median
832658|NCT01250379|Secondary|Percentage of Participants Who Died|Percentage of participants who died due to any reason were reported.|Baseline until death (up to approximately 4 years)|ITT population||percentage of participants|||Number
832659|NCT01250379|Primary|Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 6|Second-line PFS was defined as the time from randomization to PD or death due to any cause during their second-line of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented.|Month 6|ITT population||percentage of participants||95% Confidence Interval|Number
832660|NCT01250379|Secondary|Time to Second- and Third-Line Tumor Progression|The median time, in months, from randomization to second- and third-line tumor progression. Second­ and third­line tumor progression was defined as third­line PD according to RECIST v1.1 or death due to progression of disease. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without third-line PD or death were censored at the date of last tumor assessment where non-progression was documented.|Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 4 years|ITT population||months||95% Confidence Interval|Median
832661|NCT01250379|Secondary|Percentage of Participants With Second- and Third-Line Tumor Progression|Second- and third-line tumor progression was defined as occurrence of third-line PD according to RECIST v1.1 or death due to progression of disease. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without third-line PD or death due to progression of disease were censored at the date of last tumor assessment where non-progression was documented.|Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 4 years|ITT population||percentage of participants|||Number
832679|NCT01250730|Primary|Metabolite to Parent Ratio Cmax|The metabolic ratio (MR) is calculated by first converting the Cmax for both crizotinib and metabolite (PF-06260182) from mass units to molar units.|0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose|||ratio||Standard Deviation|Geometric Mean
832663|NCT01250379|Secondary|Percentage of Participants With Second- and Third-Line PFS According to RECIST v1.1|Second- and third-line PFS was defined as the time from the date randomization to the date of third-line PD or death due to any cause. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without third-line PD or death were censored at the date of last tumor assessment where non-progression was documented.|Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 4 years|ITT population||percentage of participants|||Number
832664|NCT01250379|Secondary|Third-Line PFS|The median time, in months, from the first dose of third-line bevacizumab and/or chemotherapy to third-line PD or death due to any cause. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without third-line PD or death were censored at the date of last tumor assessment where non-progression was documented.|First dose of third-line treatment until PD or death due to any cause (over a period of approximately 14 months)|Third line ITT population||months||95% Confidence Interval|Median
832665|NCT01250379|Secondary|Percentage of Participants With Third-Line PFS According to RECIST v1.1|Third-line PFS was defined as the time from the date of first dose of third-line bevacizumab and/or chemotherapy to the date of third-line PD or death due to any cause. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented. Participants without third-line PD or death were censored at the date of last tumor assessment where non-progression was documented.|First dose of third-line treatment until PD or death due to any cause (assessed every 8-9 weeks, over a period of approximately 14 months)|Third line ITT population: all randomized participants who received third-line treatment.||percentage of participants|||Number
832666|NCT01250379|Secondary|Percentage of Participants With a Second-Line Documented CR or PR According to RECIST v1.1 Estimated to be Alive and Free of Disease Progression at Months 3, 6, and 9 (Data Cutoff 20 December 2013)|Duration of objective response was defined as the median time, in months, from the date of the first second-line documentation of CR or PR to the date of the first second-line documentation of PD or death due to any cause. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels, and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants with CR or PR who had experienced neither disease progression nor died were censored at the date of the last available tumor assessment when the participant was known to be progression free.|Months 3, 6, and 9|ITT population; only randomized participants with a CR or PR were included in the analysis.||percentage of participants||95% Confidence Interval|Number
832667|NCT01250379|Secondary|Duration of Second-Line Objective Response (Data Cutoff 20 December 2013)|The median time, in months, from the date of the first second-line documentation of CR or PR according to RECIST v1.1 to the date of the first second-line documentation of PD or death due to any cause. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels, and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants with CR or PR who had experienced neither disease progression nor died were censored at the date of the last available tumor assessment when the participant was known to be progression free.|Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years|ITT population; only randomized participants with a CR or PR were included in the analysis.||months||95% Confidence Interval|Median
832668|NCT01250379|Secondary|Percentage of Participants With a Second-Line CR, PR, Stable Disease, and PD According to RECIST v1.1 (Data Cutoff 20 December 2013)|For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; stable disease was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits; and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. The 95% CI was determined using the Pearson-Clopper method.|Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years|ITT population; only randomized participants with measurable disease at baseline were included in the analysis.||percentage of participants||95% Confidence Interval|Number
832669|NCT01250379|Secondary|Percentage of Participants With a Second-Line Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) According to RECIST v1.1 (Data Cutoff 20 December 2013)|BOR was defined as a confirmed CR or PR during second-line treatment. For TLs, CR was defined as the disappearance of all TLs, and PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. The 95% Cl was determined using the Pearson-Clopper method.|Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years|ITT population; only randomized participants with measurable disease at baseline were included in the analysis.||percentage of participants||95% Confidence Interval|Number
832670|NCT01250379|Secondary|Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013)|The median time, in months, from randomization to second-line PFS event according to the following baseline risk factors: hormone receptor negative, HER2 negative (triple negative), hormone receptor positive/HER-2 negative (HR-pos/HER-neg), first-line PFS less than (<) 6 months, first-line PFS greater than or equal to (≥) 6 months, taxane chemotherapy (chemo), non-taxane chemo, vinorelbine chemo, LDH ≤ 1.5 upper limit of normal (ULN), LDH greater than (>) 1.5 ULN, < 65 years of age, ≥ 65 years of age, < 70 years of age, ≥ 70 years of age, < 3 metastatic organ sites, ≥ 3 metastatic organ sites, bevacizumab-free (B-free) interval ≤ 6 weeks, B-free > 6 weeks, disease-free (D-free) interval ≤ 24 months, D-free > 24 months, D-free ≤ 12 months, and D-free > 12 months. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented. PD: defined in Outcome measure 1. The 95% CI was estimated using Kaplan-Meier methodology.|Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years|ITT population. Here, Number of participants analyzed equals (=) participants evaluable for this outcome measure and number (n) = number of participants included in the analysis for the specified risk factor.||months||95% Confidence Interval|Median
832671|NCT01250379|Primary|Second-Line PFS|The median time, in months, from randomization to second-line PFS event. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented.|Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years|ITT population||months||95% Confidence Interval|Median
832672|NCT01250379|Primary|Percentage of Participants With Second-Line Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1)|Second-line PFS was defined as the time from randomization to progressive disease (PD) or death due to any cause during their second-line of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For target lesions (TLs), PD was defined at least a 20 percent (%) increase in the sum of the largest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For non-target lesions (NTLs), PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented.|Baseline (less than or equal to [≤] 28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years|Intent-to-Treat (ITT) population - all randomized participants.||percentage of participants|||Number
832673|NCT01250418|Primary|TcCO2 Above 50|% Time Tosca Monitor (TcCO2) above 50. A TcCo2 above 50 is indicative of hypoventilation.|Intraoperative, an average of about 1 and 1/2 hours.|||Percent time intraoperatrive||Standard Deviation|Mean
832674|NCT01250509|Secondary|Change in Psychological Stress (Baseline and 4 Months)|The 10-item Perceived Stress Scale was used to evaluate perception of stressful events over the past month by using a 5-point Likert scale (0 = never to 4 = very often) (Cohen et al., 1983). The mean of the ten items was used in analysis. Higher scores indicate greater perceived stress.|Change from Baseline in Psychological Stress|An intention-to-treat analysis was conducted. Assuming participants lost to followup did not change over time, missing data at postintervention were imputed using preintervention values.||units on a scale||Standard Deviation|Mean
832675|NCT01250509|Secondary|Telomerase Activity|Cryopreserved peripheral blood nuclear cells (PBMCs) were thawed and live cells counted using a hemocytometer by the Trypan blue exclusion method. For each sample, an extract of 5000 cells per microliter was made and two concentrations, corresponding to 5000 and 10,000 cells, were assayed for each sample to ensure the assay was in the linear range. Telomerase activity was assayed by the Telomerase Repeat Amplification Protocol (TRAP) using a commercial kit (TRAPeze, Telomerase Detection kit, Upstate/ CHEMICON, Temecula, CA). Baseline and post-intervention samples for the same participant were assayed in the same batch and run on the same gel to eliminate any differences caused by reaction or procedural batch-to-batch variations. Technicians were blind to group assignment. Telomerase activity is defined as 1 unit = the amount of product from one 293T cell/10,000 PBMCs, and was quantified using the software ImageQuant 5.2 (GE Healthcare, Piscataway, NJ).|Change from Baseline in Telomerase Activity at 4 months|Intention-to-treat analysis was conducted.||Standard arbitrary units, see above||Standard Deviation|Mean
832676|NCT01250509|Secondary|Weight||Change in Weight (baseline and 4 months)|Intention to treat analysis was conducted. Assuming participants lost to followup did not change over time, missing data at postintervention were imputed using preintervention values.||kg||Standard Deviation|Mean
832677|NCT01250509|Primary|Change in Abdominal Fat|Whole-body dual energy X-ray absorptiometry (DEXA) scans were performed to assess body fat distribution. The DEXA densitometry (GE Healthcare Lunar Prodigy, Madison, Wis, USA) was adjusted to the fan beam mode and EnCore software version 9.15 was used. The primary region of interest was fat tissue from a rectangular region in the abdominal area defined by the upper boundary of the second lumbar vertebra to the lower edge of the fourth lumbar vertebra. The vertical sides were defined as the continuation of the lateral sides of the rib cage.|Change from Baseline in Abdominal Fat (baseline and 4 months)|Intent-to-treat analyses were conducted. Assuming participants lost to followup did not change over time, missing data at postintervention were imputed using preintervention values.||grams||Standard Deviation|Mean
832678|NCT01250717|Primary|Pathologic Complete Response Was Assessed by Rigorous Pathological Examination by One of Two Pathologists|One of two pathologists (SR, EG), assigned the Gleason scores for each patient from pre-treatment prostate biopsies and assessed pathological staging on post- prostatectomy specimens. Staging including a description of all tumor foci within the gland, presence or absence of perineural invasion and/or lymphovascular invasion, presence of extraprostatic extension of tumor (including seminal vesicle invasion), and margin status. The pathologists reviewed the presence or absence of cancer in each prostate gland removed on the study patients. RECIST has to my knowledge not been used for pathological examination in neoadjuvant studies. 0 out of 28 participants acheived complete response. RECIST is not appropriate as cancer within the gland at the time of treatment is not measurable by RECIST. The primary outcome is a pathological complete response.|status post prostectomy|||participants|||Number
832685|NCT01250730|Primary|Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time (AUC0-inf) of Plasma Active Metabolite (PF-06260182)|"AUC(0-inf) of PF-06260182 is estimated from the PF-06260182 concentration. It is obtained from AUClast plus (Clast/kel).
AUClast = area under the plasma concentration-time curve from zero time until the last measurable concentration.
Clast = the last quantifiable concentration. Kel = terminal phase elimination rate constant."|0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose|||ng*hr/mL||Standard Deviation|Geometric Mean
832686|NCT01250730|Primary|Dose Normalized Cmax of Crizotinib|Dose normalized (to 150 mg dose) Cmax is obtained from Cmax / (Dose/150).|0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose|||ng/mL||Standard Deviation|Geometric Mean
832687|NCT01250730|Primary|Dose Normalized AUClast of Crizotinib|Dose normalized (to 150 mg dose) AUClast is obtained from AUClast / (Dose/150).|0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose|||ng*hr/mL||Standard Deviation|Geometric Mean
832688|NCT01250730|Primary|Dose Normalized AUC(0-inf) of Crizotinib|Dose normalized (to 150 mg dose) AUC(0-inf) is obtained from AUC(0-inf) / (Dose/150).|0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose|||ng*hr/mL||Standard Deviation|Geometric Mean
832689|NCT01250730|Primary|Apparent Volume of Distribution (Vz/F) of Crizotinib|"Vz/F of crizotinib is obtained from a Dose / (AUCinf *kel).
Kel = terminal phase elimination rate constant"|0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose|||Liter||Standard Deviation|Geometric Mean
832690|NCT01250730|Primary|Apparent Oral Clearance (CL/F) of Crizotinib|CL/F of crizotinib is obtained from a Dose per AUCinf.|0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose|||liter per hour||Standard Deviation|Geometric Mean
832691|NCT01250730|Primary|Terminal Elimination Half-life (t1/2) of Crizotinib|"t1/2 of crizotinib is the time measured for the plasma concentration to decrease by one half. It is obtained from a Loge(2)/kel.
Kel = terminal phase elimination rate constant"|0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose|||hours||Standard Deviation|Mean
832692|NCT01250730|Primary|Time to Cmax (Tmax) of Crizotinib||0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose|||ng/mL||Full Range|Median
832693|NCT01250730|Primary|Maximum Plasma Concentration (Cmax) of Crizotinib||0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose|||ng/mL||Standard Deviation|Geometric Mean
832694|NCT01250730|Primary|Area Under the Plasma Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Crizotinib|AUClast of crizotinib is estimated from the crizotinib concentration. It is obtained from Linear/Log trapezoidal method.|0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose|||ng*hr/mL||Standard Deviation|Geometric Mean
832695|NCT01250730|Primary|Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time [AUC(0-inf)] of Crizotinib|"AUC(0-inf) of crizotinib is estimated from the crizotinib concentration. It is obtained from AUClast plus (Clast/kel).
AUClast = area under the plasma concentration-time curve from zero time until the last measurable concentration.
Clast = the last quantifiable concentration. Kel = terminal phase elimination rate constant."|0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose|||ng*hr/mL||Standard Deviation|Geometric Mean
832696|NCT01250756|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 3 (13 to 16.5 Months of Age)|Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]), were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 7 days after Catch-up Dose 3|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic event. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction.||Percentage of participants|||Number
832697|NCT01250756|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age)|Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]), were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 7 days after Catch-up Dose 2|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic event. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction.||Percentage of participants|||Number
832698|NCT01250756|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age)|Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]), were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 7 days after Catch-up Dose 1|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic event. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction.||Percentage of participants|||Number
832699|NCT01250756|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age)|Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]), were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 7 days after the toddler dose|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic event. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction for each group, respectively.||Percentage of participants|||Number
832715|NCT01250756|Secondary|Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Toddler Dose|GMCs were measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies.|1 month after the toddler dose|Evaluable toddler immunogenicity set: eligible participants who received vaccine to which they were randomized at all 4 doses, had blood drawn within protocol-specified time, had at least 1 valid, determinate assay result after toddler dose for analysis, received no prohibited vaccines, and had no major protocol violations.||EU/mL||95% Confidence Interval|Geometric Mean
832700|NCT01250756|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age)|Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]), were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 7 days after Dose 3 of the infant series|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic event. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction for each group, respectively.||Percentage of participants|||Number
832701|NCT01250756|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age)|Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]), were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 7 days after Dose 2 of the infant series|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic event. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction for each group, respectively.||Percentage of participants|||Number
832702|NCT01250756|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age)|Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]), were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 7 days after Dose 1 of the infant series|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic event. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction for each group, respectively.||Percentage of participants|||Number
832703|NCT01250756|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 3 (13 to16.5 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was catch-up 7vPnC injection site in the DTaP (Catch-up 7vPnC) group.|Within 7 days after Catch-up Dose 3|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction.||Percentage of participants|||Number
832704|NCT01250756|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was catch-up 7vPnC injection site in the DTaP (Catch-up 7vPnC) group.|Within 7 days after Catch-up Dose 2|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction.||Percentage of participants|||Number
832705|NCT01250756|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was catch-up 7vPnC injection site in the DTaP (Catch-up 7vPnC) group.|Within 7 days after Catch-up Dose 1|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction.||Percentage of participants|||Number
832706|NCT01250756|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group.|Within 7 days after the toddler dose|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.||Percentage of participants|||Number
832716|NCT01250756|Secondary|Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Toddler Dose|GMCs were measured in IU/mL and corresponding 2-sided 95% CI were evaluated for diphtheria and tetanus antibodies.|1 month after the toddler dose|Evaluable toddler immunogenicity set: eligible participants who received vaccine to which they were randomized at all 4 doses, had blood drawn within protocol-specified time, had at least 1 valid, determinate assay result after toddler dose for analysis, received no prohibited vaccines, and had no major protocol violations.||IU/mL||95% Confidence Interval|Geometric Mean
832730|NCT01250834|Secondary|Pharmacokinetics of Ortho-Hydroxyatorvastatin: Maximum Concentration (Cmax)||Pre-dose to 56 hours post-dose|All randomized participants who received at least 1 dose of study drug and have evaluable pharmacokinetic (PK) data.||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
832707|NCT01250756|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group.|Within 7 days after Dose 3 of the infant series|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.||Percentage of participants|||Number
832708|NCT01250756|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group.|Within 7 days after Dose 2 of the infant series|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.||Percentage of participants|||Number
832709|NCT01250756|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group.|Within 7 days after Dose 1 of the infant series|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.||Percentage of participants|||Number
832710|NCT01250756|Secondary|Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Catch-up Dose 3|Antibody GMCs for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.|1 month after the catch-up dose 3|Catch-up immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 catch-up doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.||mcg/mL||95% Confidence Interval|Geometric Mean
832711|NCT01250756|Secondary|Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 Mcg/mL 1 Month After Catch-up Dose 3|Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) were presented. Exact 2-sided CI based on the observed proportion of participants.|1 month after the catch-up dose 3|Catch-up immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 catch-up doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.||Percentage of participants||95% Confidence Interval|Number
832712|NCT01250756|Secondary|Geometric Mean Fold Rise (GMFR) of Pneumococcal Antibodies From Pretoddler Dose to 1 Month After the Toddler Dose|Geometric mean fold rises (GMFRs) for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results. CI for the GMFRs were back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.|Pre-toddler dose, 1 month after the toddler dose|Evaluable toddler immunogenicity set: eligible participants who received vaccine to which they were randomized at all 4 doses, had blood drawn within protocol-specified time, had at least 1 valid, determinate assay result after toddler dose for analysis, received no prohibited vaccines, and had no major protocol violations.||Fold Rise||95% Confidence Interval|Geometric Mean
832713|NCT01250756|Secondary|Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose|Antibody GMCs for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were presented. GMC and corresponding 2-sided 95% CIs were evaluated. GMs were calculated using all participants with available data for the specified blood draw.|1 month after the toddler dose|Evaluable toddler immunogenicity set: eligible participants who received vaccine to which they were randomized at all 4 doses, had blood drawn within protocol-specified time, had at least 1 valid, determinate assay result after toddler dose for analysis, received no prohibited vaccines, and had no major protocol violations.||mcg/mL||95% Confidence Interval|Geometric Mean
832714|NCT01250756|Secondary|Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 Mcg/mL 1 Month After the Toddler Dose|Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) were presented. Exact 2-sided CI based on the observed proportion of participants.|1 month after the toddler dose|Evaluable toddler immunogenicity set: eligible participants who received vaccine to which they were randomized at all 4 doses, had blood drawn within protocol-specified time, had at least 1 valid, determinate assay result after toddler dose for analysis, received no prohibited vaccines, and had no major protocol violations.||Percentage of participants||95% Confidence Interval|Number
832717|NCT01250756|Secondary|Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Toddler Dose|Percentage of participants achieving predefined antibody level along with the corresponding 95% CI were presented. Exact 2-sided CI based on the observed proportion of participants. Predefined antibody levels were 0.1 IU/mL for diphtheria, 0.01 IU/mL for tetanus, 5 EU/mL for PT, and 5 EU/mL for FHA.|1 month after the toddler dose|Evaluable toddler immunogenicity set: eligible participants who received vaccine to which they were randomized at all 4 doses, had blood drawn within protocol-specified time, had at least 1 valid, determinate assay result after toddler dose for analysis, received no prohibited vaccines, and had no major protocol violations.||Percentage of participants||95% Confidence Interval|Number
832718|NCT01250756|Primary|Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series|Antibody geometric mean concentrations (GMCs) for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were presented. GMC and corresponding 2-sided 95% CI were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.|1 month after the infant series|Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.||mcg/mL||95% Confidence Interval|Geometric Mean
832719|NCT01250756|Primary|Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series|Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) were presented. Exact 2-sided CI based on the observed proportion of participants.|1 month after the infant series|Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.||Percentage of participants||95% Confidence Interval|Number
832720|NCT01250756|Primary|Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Infant Series|GMCs were measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies.|1 month after the infant series|Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.||EU/mL||95% Confidence Interval|Geometric Mean
832721|NCT01250756|Primary|Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Infant Series|Geometric mean concentrations (GMCs) were measured in IU/mL and corresponding 2-sided 95% confidence interval (CI) were evaluated for diphtheria and tetanus antibodies.|1 month after the infant series|Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.||IU/mL||95% Confidence Interval|Geometric Mean
832722|NCT01250756|Primary|Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Infant Series|Percentage of participants achieving predefined antibody level along with the corresponding 95% confidence interval (CI) were presented. Exact 2-sided CI based on the observed proportion of participants. Predefined antibody levels were 0.1 International Units/mL (IU/mL) for diphtheria, 0.01 IU/mL for tetanus, 5 Enzyme-linked Immunosorbent Assay (ELISA) units/mL (EU/mL) for pertussis toxoid (PT), and 5 EU/mL for filamentous hemagglutinin (FHA).|1 month after the infant series|Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.||Percentage of participants||95% Confidence Interval|Number
832723|NCT01250769|Secondary|Gingival Bleeding Index|Gingival bleeding evaluation using a ordinal scale of 0 to 3; (0 is best; 3 is worst)|28 days|Analysis of efficacy data was performed using a modified intent-to-treat population (MITT). The MITT Population included all randomized subjects with both a baseline and endpoint evaluation. Missing data were not imputed.||units on a scale||95% Confidence Interval|Least Squares Mean
832724|NCT01250769|Secondary|Gingival Bleeding Index|Gingival bleeding evaluation using an ordinal scale of 0 to 3; (0 is best; 3 is worst)|14 days|Analysis of efficacy data was performed using a modified intent-to-treat population (MITT). The MITT Population included all randomized subjects with both a baseline and endpoint evaluation. Missing data were not imputed.||units on a scale||95% Confidence Interval|Least Squares Mean
832725|NCT01250769|Secondary|Modified Gingival Index|Gingival inflammation evaluation on an ordinal scale of 0 to 4 (0 is best ; 4 is worst)|28 days|Analysis of efficacy data was performed using a modified intent-to-treat population (MITT). The MITT Population included all randomized subjects with both a baseline and endpoint evaluation. Missing data were not imputed.||units on a scale||95% Confidence Interval|Least Squares Mean
832726|NCT01250769|Secondary|Modified Gingival Index|Gingival inflammation evaluation on an ordinal scale of 0 to 4 (0 is best ; 4 is worst)|14 days|Analysis of efficacy data was performed using a modified intent-to-treat population (MITT). The MITT Population included all randomized subjects with both a baseline and endpoint evaluation. Missing data were not imputed.||units on a scale||95% Confidence Interval|Least Squares Mean
832727|NCT01250769|Secondary|Residual Protein Concentration|Residual protein concentration of interproximal plaque samples|28 days|Analysis of efficacy data was performed using a modified intent-to-treat population (MITT). The MITT Population included all randomized subjects with both a baseline and endpoint evaluation. Missing data were not imputed.||ug/mL||95% Confidence Interval|Least Squares Mean
832728|NCT01250769|Primary|Residual Protein Concentration|Residual protein concentration of interproximal plaque samples|14 days|Analysis of efficacy data was performed using a modified intent-to-treat population (MITT). The MITT Population included all randomized subjects with both a baseline and endpoint evaluation. Missing data were not imputed.||ug/mL||95% Confidence Interval|Least Squares Mean
832731|NCT01250834|Secondary|Pharmacokinetics of Para-Hydroxyatorvastatin: Area Under the Curve (AUC)|This measure is based on the pharmacokinetic area under the para-hydroxyatorvastatin concentration-time curve from time 0 to infinity. The outcome is not available for this metabolite since the terminal elimination phase was not determinable.|Pre-dose to 56 hours post-dose|No participants were analyzed for this outcome measure since the terminal elimination phase was not determinable.|||||
832732|NCT01250834|Secondary|Pharmacokinetics of Para-Hydroxyatorvastatin: Maximum Concentration (Cmax)||Pre-dose to 56 hours post-dose|All randomized participants who received at least 1 dose of study drug and have evaluable pharmacokinetic (PK) data.||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
832733|NCT01250834|Primary|Pharmacokinetics of Atorvastatin: Area Under the Curve (AUC)|This measure is based on the pharmacokinetic area under the atorvastatin plasma concentration-time curve from time 0 to infinity.|Pre-dose to 56 hours post-dose|All randomized participants who received at least 1 dose of study drug and have evaluable pharmacokinetic (PK) data.||nanogram*hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
832734|NCT01250834|Primary|Pharmacokinetics of Atorvastatin: Maximum Plasma Concentration (Cmax)||Pre-dose to 56 hours post-dose|All randomized participants who received at least 1 dose of study drug and have evaluable pharmacokinetic (PK) data.||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
832735|NCT01250899|Primary|Success Rate in Achieving a 25(OH)D Level ≥30ng/mL After 12 Weeks of Oral Vitamin D Supplementation.|Percentage of participants successfully repleted to 25(OH)D ≥30ng/mL after 12 weeks of oral vitamin D supplementation.|12 weeks|After 12 weeks of oral vitamin D supplementation, serum 25(OH)D levels were measured in the Vitamin D Insufficient arm. 81% (n=66) of insufficient persons achieved 25(OH)D ≥30ng/mL (p=0.32 vs. historical controls).||percentage of participants||95% Confidence Interval|Number
832736|NCT01250925|Primary|Corneal Epithelial Immune Non-Dendritic Cell Density (Temporal Cornea)|The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.|Six weeks|Participants who completed all visits were analyzed.||cells/mm2|eyes|Standard Error|Mean
832737|NCT01250925|Primary|Corneal Epithelial Immune Non-Dendritic Cell Density (Superior Cornea)|The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.|Six weeks|Participants who completed all visits were analyzed.||cells/mm2|eyes|Standard Error|Mean
832738|NCT01250925|Primary|Corneal Epithelial Immune Non-Dendritic Cell Density (Nasal Cornea)|The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.|Six weeks|Participants who completed all visits were analyzed.||cells/mm2|eyes|Standard Error|Mean
832739|NCT01250925|Primary|Corneal Epithelial Immune Non-Dendritic Cell Density (Inferior Cornea)|The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.|Six weeks|Participants who completed all visits were analyzed.||cells/mm2|eyes|Standard Error|Mean
832740|NCT01250925|Primary|Corneal Epithelial Immune Non-Dendritic Cell Density (Central Cornea)|The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.|Six weeks|Participants who completed all visits were analyzed.||cells/mm2|eyes|Standard Error|Mean
832741|NCT01250925|Primary|Corneal Epithelial Immune Dendritic Cell Density (Temporal Cornea)|The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.|Six weeks|Participants who completed the study visits were analyzed.||cells/mm2|eyes|Standard Error|Mean
832742|NCT01250925|Primary|Corneal Epithelial Immune Dendritic Cell Density (Superior Cornea)|The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.|Six weeks|Participants who completed the study visits were analyzed.||cells/mm2|eyes|Standard Error|Mean
832743|NCT01250925|Primary|Corneal Epithelial Immune Dendritic Cell Density (Nasal Cornea)|The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.|Six weeks|Participants who completed the study visits were analyzed.||cells/mm2|eyes|Standard Error|Mean
832744|NCT01250925|Primary|Corneal Epithelial Immune Dendritic Cell Density (Inferior Cornea)|The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.|Six weeks|Participants who completed the study visits were analyzed.||cells/mm2|eyes|Standard Error|Mean
832745|NCT01250925|Secondary|Number of Participants With Slit-lamp Findings, Corrected Visual Acuity (Snellen) and Adverse Events|The safety analysis will be based on slit-lamp findings, corrected visual acuity (Snellen) and adverse events (if any). No inferential statistical analyses are planned for any safety variable.|Six weeks|Participants who completed the study visits were analyzed.||participants|eyes||Number
832746|NCT01250925|Primary|Corneal Epithelial Immune Dendritic Cell Density (Central Cornea)|The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.|Six weeks|Participants who completed all visits were analyzed.||cells/mm2|eyes|Standard Error|Mean
832767|NCT01256944|Primary|LDL|"Lipid profiles, including total cholesterol, triglycerides, high-density lipoprotein (HDL), low-density lipoprotein (LDL) and sex hormone binding globulin (SHBG).
Abnormal LDL was ≧4.14mmol/L."|1 year|||mmol/L||Standard Deviation|Mean
832796|NCT01258985|Secondary|Change in Medical Outcomes Short Form-36 PCS|The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) Physical Component Score (PCS) is the summary score for the physical quality-of-life components (range, 0 to 100, with higher scores indicating better health status)|From Week 0, to Week 12, or to week 24, or to week 52|||units on a scale||95% Confidence Interval|Mean
832747|NCT01250990|Primary|Rate of Appearance of 3H Cholesterol in the Total HDL Fraction Before and After 12 Weeks of Treatment With Niacin|Subjects were injected with a bolus of 3-H cholesterol mixed with human serum albumin as an intravenous bolus. This injected labelled cholesterol is taken up by macrophages. The rate of appearance of labelled cholesterol in plasma HDL- cholesterol is a measure of reverse cholesterol transport. We assessed HDL cholesterol enrichment as percent of injected tritiated tracer appearing in plasma total HDL cholesterol between 60 and 240 minutes post-injection expressed as percent 3-H cholesterol/mol HDL cholesterol/hour. The tracer study was performed at baseline and after 12 weeks of niacin or placebo.|Baseline and 12 weeks|Of the 22 subjects enrolled, only subjects who completed the baseline and 12 week reverse cholesterol transport studies were included in the final outcome analysis.||%/mol/h||95% Confidence Interval|Mean
832748|NCT01251042|Secondary|Frequency of Allogenic Blood Transfusion||Up until 96 hours after surgery (surgery takes place 1-7 days after screening)|All subjects randomized.||percentage of participants|||Number
832749|NCT01251042|Secondary|Mean Blood Loss Volume|Estimated blood loss during and after surgery.|After surgery (surgery takes place 1-7 days after screening)|All subjects randomized.||ml||Full Range|Mean
832750|NCT01251042|Secondary|Interferon Gamma (IFN-γ) Concentration|Systemic IFN-γ concentration from screening until 96 hours after surgery.|At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)|All subjects randomized.||pg/ml||Standard Deviation|Mean
832751|NCT01251042|Secondary|Tumor Necrosis Factor Alpha (TNF-α) Concentration|Systemic TNF-α concentration from screening until 96 hours after surgery.|At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)|All subjects randomized.||pg/ml||Standard Deviation|Mean
832752|NCT01251042|Secondary|Interleukin-10 (IL-10) Concentration|Systemic IL-10 concentration from screening until 96 hours after surgery.|At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)|All subjects randomized.||pg/ml||Standard Deviation|Mean
832753|NCT01251042|Secondary|Interleukin-8 (IL-8) Concentration|Systemic IL-8 concentration from screening until 96 hours after surgery.|At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)|All subjects randomized.||pg/ml||Standard Deviation|Mean
832754|NCT01251042|Secondary|Interleukin-6 (IL-6) Concentration|Systemic IL-6 concentration from screening until 96 hours after surgery.|At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)|All subjects randomized.||pg/ml||Standard Deviation|Mean
832755|NCT01251042|Secondary|Interleukin-1-alpha (IL-1-α) Concentration|Systemic IL-1-α concentration from screening until 96 hours after surgery.|At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)|All subjects randomized.||pg/ml||Standard Deviation|Mean
832756|NCT01251042|Primary|Difference in Plasma Free Hemoglobin (p-Hb) Concentration|Difference in plasma free hemoglobin (p-Hb) concentration between screening and 24 hours after surgery|At screening and 24 hours after surgery (surgery takes place 1-7 days after screening)|All subjects randomized.||g/l||Standard Deviation|Mean
832757|NCT01251042|Secondary|Creatinine Concentration|Systemic creatinine concentration from screening until 96 hours after surgery.|At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)|All subjects randomized.||μmol/l||Standard Deviation|Mean
832758|NCT01251042|Secondary|Potassium Concentration|Systemic potassium concentration from screening until 96 hours after surgery.|At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)|All subjects randomized.||mmol/l||Standard Deviation|Mean
832759|NCT01251042|Secondary|Hemoglobin Concentration|Systemic hemoglobin concentration from screening until 96 hours after surgery.|At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)|All subjects randomized.||g/dl||Standard Deviation|Mean
832760|NCT01251042|Secondary|Plasma Free Hemoglobin (p-Hb) Concentration|Systemic plasma free hemoglobin (p-Hb) concentration from screening until 96 hours after surgery.|At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)|All subjects randomized.||g/l||Standard Deviation|Mean
832761|NCT01256918|Primary|Correlation Between Lens Thickness and Phacodepth|"Pearson correlation coefficient would be calculated to look for any correlation between
length thickness measurement using A scan biometer for each cataract and
penetration of phacotip required to achieve a full thickness nuclear crack in vertical chop during phacoemulsification of the cataractous lens"|day 0 of surgery|||units on a scale||Standard Deviation|Mean
832762|NCT01256918|Primary|Correlation Between Nuclear Opalescence and Phacodepth|"Pearson correlation coefficient would be calculated to look for any correlation between
nuclear opalescence as per LOCS III grading system for each cataract and
penetration of phacotip required to achieve a full thickness nuclear crack in vertical chop during phacoemulsification of the cataractous lens"|day 0 of surgery|||units on a scale||Standard Deviation|Mean
832763|NCT01256918|Primary|Correlation Between Nuclear Colour and Phacodepth Required for a Safe and Effective Vertical Chop During Phacoemulsification|the nuclear colour grading as per LOCS III criteria for each case and the depth of penetration of phacotip required during a vertical chop was analysed to look for any correlation between the two.|day 0 of surgery|||units on a scale||Standard Deviation|Mean
832764|NCT01256918|Secondary|Posterior Capsular Rupture|A note shall be made of any posterior capsular rupture attributable to the attempted vertical chop .|day 0 of surgery.|". In this observational study sample size was achieved by consecutive sampling of all eyes with cataract reporting to the eye OPD of Dr. R.M.L.Hospital and fulfilling the inclusion criteria from Nov.2010 till March 2011 ,after a written informed consent.
Occurence of any posterior capsular rupture during vertical chop was noted as per protocol."||participants|||Number
832765|NCT01256918|Primary|Phacodepth Required to Achieve Full Thickness Nuclear Crack|phacodepth is the term used to describe the depth penetrated by the phacotip into the substance of lens.A note of depth penetrated by the tip to achieve full thickness nuclear crack shall be made.|day 0 of surgery|A consecutive sample of all eyes with cataract reporting to the eye OPD of Dr. R.M.L.Hospital and fulfilling the inclusion criteria, were enrolled in the study starting Nov.2010 till Jan 2011 ,after a written informed consent.||mm||Standard Deviation|Mean
832766|NCT01256944|Primary|Impaired Glucose Tolerance|Impaired glucose tolerance was defined as two hour glucose levels of 7.8–11.1 mmol/L in the 75 g oral glucose tolerance test. In women with impaired glucose tolerance, the fasting plasma glucose level should be <7 mmol/L.|1 years|||percentage of participants|||Number
832768|NCT01256944|Primary|HDL|"Metabolic syndrome was defined (2005 National Cholesterol Education Program, Adult Treatment Panel III) as the presence of at least three of the following criteria:
abdominal obesity (waist circumference >80 cm in women); serumtriglycerides≥1.7 mmol/L; serumHDL<1.3 mmol/L; systolic blood pressure ≥130 mmHg and/or diastolic blood pressure ≥85 mmHg; and fasting plasma glucose ≥7.0 mmol/L."|1 year|||mmol/L||Standard Deviation|Mean
832769|NCT01256944|Primary|Triglycerides|Abnormal serum triglycerides defined as ≥ 1.7 mmol/L|1 year|||mmol/L||Standard Deviation|Mean
832770|NCT01256944|Primary|Cholesterol|Hypercholesterolemia was defined as >6 mmol / L.|1 year|||mmol/L||Standard Deviation|Mean
832771|NCT01256944|Primary|Homeostasis Model Assessment Insulin Resistance Index (HOMA-IR)|HOMA-IR = [fasting insulin (in μIU/mL) × fasting glucose (in mg/dL)]/405.|1 year|||unitless||Standard Deviation|Mean
832772|NCT01256944|Primary|Two Hour Glucose|"2-hour postprandial blood sugar measures blood glucose exactly 2 hours after you start eating a meal. This is not a test used to diagnose diabetes.
World Health Organization 2006 diagnostic criteria for diabetes were employed (fasting plasma glucose ≥7.0 mmol/L or two hour plasma glucose ≥11.1 mmol/L)."|1 year|||mmol/L||Standard Deviation|Mean
832773|NCT01256944|Primary|Fasting Glucose|"Fasting blood sugar (FBS) measures blood glucose after you have not eaten for at least 8 hours. It is often the first test done to check for prediabetes and diabetes.
World Health Organization 2006 diagnostic criteria for diabetes were employed (fasting plasma glucose ≥7.0 mmol/L or two hour plasma glucose ≥11.1 mmol/L)."|1 year|||mmol/L||Standard Deviation|Mean
832774|NCT01256944|Primary|Fasting Insulin|A fasting serum insulin level of greater than the upper limit of normal for the assay used (approximately 60 pmol/L) is considered evidence of insulin resistance.|1 year|||μIU/ml||Standard Deviation|Mean
832775|NCT01256944|Primary|BMI|BMI categorization was based on the WHO Asia–Pacific classification for obesity, which was defined as BMI ≧ 25 kg/m2(WHO: Obesity: preventing and managing the global epidemic. Geneva: WHO; 2000).|1 year|||kg/m2||Standard Deviation|Mean
832776|NCT01256944|Primary|Total Testosterone|Using serum total testosterone to represent the severity of hyperandrogenism.|1 year|||nmol/L||Standard Deviation|Mean
832777|NCT01256983|Primary|Bedtime|"The mean bedtime assessed by actimetry of each 3 week period (day 21, 42, 63 ) was used as outcome to be compared with the control group.
Bedtime is expressed in time (hours and minutes)"|Mean Bedtimes over 21 days for each period|||Hours||Standard Deviation|Mean
832778|NCT01258790|Primary|Yale Global Tic Severity Scale|The tic severity score based on Yale Global Tic Severity Scale ranges from 0 - 50. A person who has no tics would have a score of 0. High score means a person has severe tics.|1 week|||units on a scale (0 - 50)||Standard Deviation|Mean
832779|NCT01258803|Secondary|Change From Baseline in Forced Vital Capacity (FVC) After a Single Dose of MF/F MDI With Spacer, MF/F MDI Without Spacer, F DPI or Placebo MDI Combined With or Without Spacer at 5 and 30 Minutes, 1, 2, 4, 8 and 12 Hours Postdose|Baseline was defined as the average of 2 predose FVC measurements (taken 30 minutes and immediately before dosing).|Baseline and 5 and 30 minutes, 1, 2, 4, 8 and 12 hours postdose|Participants who received each assigned single-dose treatment, performed at least the 0- and 2-hour spirometry evaluations and met the following criteria: did not use any prohibited concomitant medications; demonstrated satisfactory use of inhaler, space and spirometry maneuvers; and used >80% of prescribed MF DPI across the entire study treatment||Liters||Standard Error|Least Squares Mean
832780|NCT01258803|Secondary|AUC (0-12h) of the Change From Baseline in FEV1 After a Single Dose of F DPI Compared to Placebo MDI Combined With or Without Spacer|The AUC was standardized to liters by dividing the length of time for which measurements of FEV1 were included in the calculation of the AUC. Baseline was defined as the average of 2 pre-dose FEV1 measurements (taken 30 minutes before and immediately before dosing), which was subtracted from each of the serial FEV1 measurements over the 12-hour period. The AUC was calculated based on these changes from the baseline evaluations using the trapezoidal rule.|Up to 12 hours postdose|Participants who received each assigned single-dose treatment, performed at least the 0- and 2-hour spirometry evaluations and met the following criteria: did not use any prohibited concomitant medications; demonstrated satisfactory use of inhaler, space and spirometry maneuvers; and used >80% of prescribed MF DPI across the entire study treatment||Liters||Standard Error|Least Squares Mean
832781|NCT01258803|Secondary|AUC (0-12h) of the Change From Baseline in FEV1 After a Single Dose of MF/F Without Spacer Compared to F DPI|The AUC was standardized to liters by dividing the length of time for which measurements of FEV1 were included in the calculation of the AUC. Baseline was defined as the average of 2 pre-dose FEV1 measurements (taken 30 minutes before and immediately before dosing), which was subtracted from each of the serial FEV1 measurements over the 12-hour period. The AUC was calculated based on these changes from the baseline evaluations using the trapezoidal rule.|Up to 12 hours postdose|Participants who received each assigned single-dose treatment, performed at least the 0- and 2-hour spirometry evaluations and met the following criteria: did not use any prohibited concomitant medications; demonstrated satisfactory use of inhaler, space and spirometry maneuvers; and used >80% of prescribed MF DPI across the entire study treatment||Liters||Standard Error|Least Squares Mean
832782|NCT01258803|Secondary|AUC (0-12h) of the Change From Baseline in FEV1 After a Single Dose of MF/F With Spacer Compared to F DPI|The AUC was standardized to liters by dividing the length of time for which measurements of FEV1 were included in the calculation of the AUC. Baseline was defined as the average of 2 pre-dose FEV1 measurements (taken 30 minutes before and immediately before dosing), which was subtracted from each of the serial FEV1 measurements over the 12-hour period. The AUC was calculated based on these changes from the baseline evaluations using the trapezoidal rule.|Up to 12 hours postdose|Participants who received each assigned single-dose treatment, performed at least the 0- and 2-hour spirometry evaluations and met the following criteria: did not use any prohibited concomitant medications; demonstrated satisfactory use of inhaler, space and spirometry maneuvers; and used >80% of prescribed MF DPI across the entire study treatment||Liters||Standard Error|Least Squares Mean
832795|NCT01258985|Secondary|Change in 6 Minute Walk|The 6 minute Walk Test is a measure of functional exercise capacity. Participants are asked to walk as far as possible within a six-minute period, and the distance covered at the end is noted and recorded.|From Week 0, to Week 12, or to week 24, or to week 52|||meters||95% Confidence Interval|Mean
833983|NCT01263496|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 24).|The change between the value of fasting plasma glucose collected at week 24 and fasting plasma glucose collected at baseline.|Baseline and Week 24.|Values are Summary Statistics.||mg/dL||Standard Deviation|Mean
832783|NCT01258803|Secondary|Change From Baseline in FEV1 After a Single Dose of MF/F MDI With Spacer, MF/F MDI Without Spacer, F DPI or Placebo MDI Combined With or Without Spacer at 5 and 30 Minutes, 1, 2, 4, 8 and 12 Hours Postdose|Baseline was defined as the average of 2 predose measurements (taken 30 minutes and immediately before dosing).|Baseline and 5 and 30 minutes, 1, 2, 4, 8 and 12 hours postdose|Participants who received each assigned single-dose treatment, performed at least the 0- and 2-hour spirometry evaluations and met the following criteria: did not use any prohibited concomitant medications; demonstrated satisfactory use of inhaler, spacer and spirometry maneuvers; and used >80% of prescribed MF DPI across the entire study treatment||Liters||Standard Error|Least Squares Mean
832784|NCT01258803|Secondary|AUC(0-12h) of the Change From Baseline in FEV1 After a Single Dose of MF/F MDI With Spacer Compared to MF/F MDI Without Spacer|The AUC was standardized to liters by dividing the length of time for which measurements of FEV1 were included in the calculation of the AUC. Baseline was defined as the average of 2 pre-dose FEV1 measurements (taken 30 minutes before and immediately before dosing), which was subtracted from each of the serial FEV1 measurements over the 12-hour period. The AUC was calculated based on these changes from the baseline evaluations using the trapezoidal rule.|Up to 12 hours postdose|Participants who received each assigned single-dose treatment, performed at least the 0- and 2-hour spirometry evaluations and met the following criteria: did not use any prohibited concomitant medications; demonstrated satisfactory use of inhaler, spacer and spirometry maneuvers; and used >80% of prescribed MF DPI across the entire study treatment||Liters||Standard Error|Least Squares Mean
832785|NCT01258803|Secondary|AUC(0-12h) of the Change From Baseline in FEV1 After a Single Dose MF/F MDI Without Spacer Compared to Placebo MDI Combined With or Without Spacer|The AUC was standardized to liters by dividing the length of time for which measurements of FEV1 were included in the calculation of the AUC. Baseline was defined as the average of 2 pre-dose FEV1 measurements (taken 30 minutes before and immediately before dosing), which was subtracted from each of the serial FEV1 measurements over the 12-hour period. The AUC was calculated based on these changes from the baseline evaluations using the trapezoidal rule.|Up to 12 hours postdose|Participants who received each assigned single-dose treatment, performed at least the 0- and 2-hour spirometry evaluations and met the following criteria: did not use any prohibited concomitant medications; demonstrated satisfactory use of inhaler, spacer and spirometry maneuvers; and used >80% of prescribed MF DPI across the entire study treatment||Liters||Standard Error|Least Squares Mean
832786|NCT01258803|Primary|Area Under the Curve From 0-12 Hours (AUC[0-12h]) of the Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) After a Single Dose of MF/F MDI With Spacer Compared to Placebo MDI Combined With or Without Spacer|The AUC was standardized to liters by dividing the length of time for which measurements of FEV1 were included in the calculation of the AUC. Baseline was defined as the average of 2 pre-dose FEV1 measurements (taken 30 minutes before and immediately before dosing), which was subtracted from each of the serial FEV1 measurements over the 12-hour period. The AUC was calculated based on these changes from the baseline evaluations using the trapezoidal rule.|Up to 12 hours postdose|Participants who received each assigned single-dose treatment, performed at least the 0- and 2-hour spirometry evaluations and met the following criteria: did not use any prohibited concomitant medications; demonstrated satisfactory use of inhaler, spacer and spirometry maneuvers; and used >80% of prescribed MF DPI across the entire study treatment||Liters||Standard Error|Least Squares Mean
832787|NCT01258985|Secondary|Change in Western Ontario and McMasters University Osteoarthritis Index (WOMAC) Pain Subscale|The WOMAC (version VA3.1) is a validated, self-administered, visual analogue scale specifically designed to evaluate knee and hip osteoarthritis. It has three subscales that are analyzed separately: pain (score range, 0-500), stiffness (0-200), and function (0-1700), with higher scores indicating more severe disease.|From Week 0, to week 24 or to week 52|||units on a scale||95% Confidence Interval|Mean
832788|NCT01258985|Secondary|Outcome Expectation Scale|The Outcome Expectations for Exercise Scale (range, 1 to 5, with 1 indicating no expectations for exercise and 5 the highest expectations for exercise) is a self-report measure of outcome expectations for exercise.|Week 0|||units on a scale||Standard Deviation|Mean
832789|NCT01258985|Secondary|Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Physical Function|The WOMAC (version VA3.1) is a validated, self-administered, visual analogue scale specifically designed to evaluate knee and hip osteoarthritis. It has three subscales that are analyzed separately: pain (score range, 0–500), stiffness (0–200), and function (0–1700), with higher scores indicating more severe disease.|From Week 0, to Week 12, or to week 24, or to week 52|||units on a scale||95% Confidence Interval|Mean
832790|NCT01258985|Secondary|Change in Short-Form Health Survey (SF-36) Mental Component Score (MCS)|The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) Mental Component Score (MCS) is the summary score for the mental quality-of-life components (range, 0 to 100, with higher scores indicating better health status)|From Week 0, to Week 12, or to week 24, or to week 52|||units on a scale||95% Confidence Interval|Mean
832791|NCT01258985|Secondary|Change in Arthritis Self-Efficacy Scale|The Arthritis Self-Efficacy Scale is a self-report score measuring self-efficacy with respect to arthritis (range, 1 to 10, with higher scores indicating greater self-efficacy).|From Week 0, to Week 12, or to week 24, or to week 52|||units on a scale||95% Confidence Interval|Mean
832792|NCT01258985|Secondary|Change in Beck II Depression Inventory|Beck II Depression Inventory (BDI), second edition, is a 21-question, validated, self-report instrument that measures the severity of depressive symptoms. Total scores range from 0-63, and higher scores reflect greater depressive symptoms. BDI scores ranging from 0-13 represent minimal depressive symptoms; scores from 14-19 are mild; scores from 20-28 are moderate; and scores from 29-63 represent severe depressive symptoms.|From Week 0, to Week 12, or to week 24, or to week 52|||units on a scale||95% Confidence Interval|Mean
832793|NCT01258985|Secondary|Change in Patient Global VAS|Patients' global assessment score (Patient Global VAS) was assessed separately by the participant, who was unaware of the group assignment, with the use of a visual-analogue scale (VAS) (range, 0 to 10,with higher scores indicating greater pain).|From Week 0, to Week 12, or to week 24, or to week 52|||units on a scale||95% Confidence Interval|Mean
832794|NCT01258985|Secondary|Change in 20 Meter Walk Test|the 20-meter walk test is a performance measurement of walking ability (measured as the total number of seconds it takes to walk 20 meters); lower scores indicate improved walking ability|From Week 0, to Week 12, or to week 24, or to week 52|||seconds||95% Confidence Interval|Mean
832797|NCT01258985|Primary|Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)Pain Subscale From Baseline to 12 Weeks|The WOMAC (version: Visual Analog Scale 3.1) is a validated, self-administered, visual analogue scale specifically designed to evaluate knee and hip osteoarthritis. It has three subscales that are analyzed separately: pain (score range, 0–500), stiffness (0–200), and function (0–1700), with higher scores indicating more severe disease.|From Week 0 to Week 12|||units on a scale||95% Confidence Interval|Mean
832798|NCT01258998|Secondary|Incidence of Adverse Events as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0|Toxicity data will be summarized by frequency tables. The association between both type and severity of toxicity and the treatment groups will be evaluated.|Up to 30 days||||||
832799|NCT01258998|Secondary|Change in Biomarker Levels of Interest (Akt, pAKT, and Apoptosis [Annexin-V])|Association between markers and OR using logistic regression models, and the association between markers and time-to-event outcomes using Cox proportional hazards models.|Baseline to up to 30 days post-treatment||||||
832800|NCT01258998|Secondary|Change in Chemokine Levels|Association between markers and OR using logistic regression models, and the association between markers and time-to-event outcomes using Cox proportional hazards models.|Baseline to up to 30 days post-treatment||||||
832801|NCT01258998|Secondary|Change in Cytokine Levels|Association between markers and OR using logistic regression models, and the association between markers and time-to-event outcomes using Cox proportional hazards models.|Baseline to up to 30 days post-treatment||||||
832802|NCT01258998|Secondary|Overall Survival|Will be estimated using the Kaplan-Meier method. The log-rank test will be performed to test the difference in time-to-event distributions between patient groups. Cox proportional hazards model will be used to include multiple covariates in the time-to-event analysis.|Up to 30 days||||||
832803|NCT01258998|Secondary|Duration of Response|Will be estimated using the Kaplan-Meier method. The log-rank test will be performed to test the difference in time-to-event distributions between patient groups. Cox proportional hazards model will be used to include multiple covariates in the time-to-event analysis.|From the time measurement criteria are met for complete response or partial response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 30 days||||||
832804|NCT01258998|Secondary|Progression-free Survival|Will be estimated using the Kaplan-Meier method. The log-rank test will be performed to test the difference in time-to-event distributions between patient groups. Cox proportional hazards model will be used to include multiple covariates in the time-to-event analysis.|From start of treatment to time of progression or death, whichever occurs first, assessed up to 30 days||||||
832805|NCT01258998|Primary|Objective Response Rate (ORR)|Objective response rate. Logistic regression utilized to assess the effect of patient demographic factors on OR.|4 months|Based on intent-to-treat analysis.||participants|||Number
832806|NCT01259011|Secondary|Change Over Time: Post-traumatic Distress Symptom Score|The Post-Traumatic Symptoms Scale-10 (PTSS-10) was used to assess the presence and intensity of PTSD symptoms during the preceding 7 days. This self-report scale consists of 10 statements that specifically mention symptoms related to PTSD criteria (e.g., sleep problems, nightmares, tension in the body, irritation, startle, etc.) rated on a 7-point Likert scale from 1 (Never/Rare) to 7 (Very often/Always). A total score (range 10 - 70) of > 35 is associated with a high probability that the person meets the diagnostic criteria for PTSD.|2 weeks and 3 and 6 months after patient death|||units on a scale||Standard Deviation|Mean
832807|NCT01259011|Secondary|Change Over Time: Hospital Anxiety and Depression Scale Scores|Hospital anxiety and depression (HADS) scores range from 0 to 21 with higher scores indicating greater symptom severity.|2 Weeks, and at 3 and 6 months post death|||units on a scale||Standard Deviation|Mean
832808|NCT01259011|Primary|Dyad Congruence|patient and surrogate congruence on the goals of care|2, 6, 12 months|patients on dialysis and their surrogates||percentage of congruent dyads|||Number
832809|NCT01259024|Secondary|To Track Survival Following Treatment With DEB to Confirm That Any Gains in Response Are Associated With an Increase in Survival.|4-6 weeks after initial treatment, follow-up imaging will be obtained. With positive response to treatment, follow-up imaging will be obtained every 12 weeks. If a new tumor develops or if local progression of the treated malignancy occurs, the patient may be retreated with LC Beads 4-6 weeks after the first treatment with re-imaging 4-6 weeks following each subsequent treatment.|Patients will participate in protocol until date of death, liver transplantation, or withdrawal from study.||||||
832810|NCT01259024|Primary|Monitor Safety After Treatment of DEB by Measuring Liver Function Tests and Assessing Performance Status.|4-6 weeks after initial treatment, follow-up imaging will be obtained. With positive response to treatment, follow-up imaging will be obtained every 12 weeks. If a new tumor develops or if local progression of the treated malignancy occurs, the patient may be retreated with LC Beads 4-6 weeks after the first treatment with re-imaging 4-6 weeks following each subsequent treatment.|Patients will participate in protocol until date of death, liver transplantation, or withdrawal from study.||||||
832811|NCT01259024|Primary|Determine Efficacy (Based on Whether the Study is Positive or Negative) of the Embolization With the LC Bead in Treatment of HCC With Imaging Outcomes Using Modified RECIST and EASL Criteria.|4-6 weeks after initial treatment, follow-up imaging will be obtained. With positive response to treatment, follow-up imaging will be obtained every 12 weeks. If a new tumor develops or if local progression of the treated malignancy occurs, the patient may be retreated with LC Beads 4-6 weeks after the first treatment with re-imaging 4-6 weeks following each subsequent treatment.|Patients will participate in protocol until date of death, liver transplantation, or withdrawal from study.||||||
832812|NCT01259024|Primary|To Collect Data on Patients With Hepatocellular Carcinoma (HCC) Being Treated With Chemoembolization With Doxorubicin Eluting Beads (DEB).|4-6 weeks after initial treatment, follow-up imaging will be obtained. With positive response to treatment, follow-up imaging will be obtained every 12 weeks. If a new tumor develops or if local progression of the treated malignancy occurs, the patient may be retreated with LC Beads 4-6 weeks after the first treatment with re-imaging 4-6 weeks following each subsequent treatment.|Patients will participate in protocol until date of death, liver transplantation, or withdrawal from study.|One participant was enrolled on this IDE and was treated on protocol for 14 weeks. After being made aware that CMS would not provide reimbursement, the PI decided to withdraw the patient and continued to treat off protocol.|||||
832813|NCT01259102|Secondary|Period 2: Tmax0-7d.|"Period 2 was the second application of BTDS 10: The time for absorption to return to normal measured by Tmax0-7d.
Tmax0-7d - The time from dosing to the maximum observed concentration was taken directly from the plasma concentration-time course profile. If the maximum plasma concentration was observed at 2 or more consecutive time points, the earliest time point was used for Tmax."|0 to 7 days|Pharmacokinetic Population: All subjects who satisfied the inclusion/exclusion criteria, received both applications of BTDS, and submitted to postbaseline phlebotomy through at least the 72-hour time point of both applications.||hour||Standard Error|Mean
832814|NCT01259102|Secondary|Period 1: Tmax0-7d.|"Period 1 was the first application of BTDS 10: The time for absorption to return to normal measured by Tmax0-7d.
Tmax0-7d - The time from dosing to the maximum observed concentration was taken directly from the plasma concentration-time course profile. If the maximum plasma concentration was observed at 2 or more consecutive time points, the earliest time point was used for Tmax."|0 to 7days|Pharmacokinetic Population: All subjects who satisfied the inclusion/exclusion criteria, received both applications of BTDS, and submitted to postbaseline phlebotomy through at least the 72-hour time point of both applications.||hour||Standard Error|Mean
832815|NCT01259102|Secondary|Period 2: Cmax0-7d|"Period 2 was the second application of BTDS 10: The time for absorption to return to normal measured by Cmax0-7d.
Cmax0-7d - The maximum observed concentration taken directly from the plasma concentration-time course profile."|0 to 7 days|Pharmacokinetic Population: All subjects who satisfied the inclusion/exclusion criteria, received both applications of BTDS, and submitted to postbaseline phlebotomy through at least the 72-hour time point of both applications.||pg/mL||Standard Error|Mean
832816|NCT01259102|Secondary|Period 1: Cmax0-7|"Period 1 was the first application of BTDS 10: The time for absorption to return to normal measured by Cmax0-7.
Cmax0-7d - The maximum observed concentration taken directly from the plasma concentration-time course profile."|0 to 7 days|Pharmacokinetic Population: All subjects who satisfied the inclusion/exclusion criteria, received both applications of BTDS, and submitted to postbaseline phlebotomy through at least the 72-hour time point of both applications.||pg/mL||Standard Error|Mean
832817|NCT01259102|Secondary|Period 2: AUC0-7d|"Period 2 was the second application of BTDS 10: The time for absorption to return to normal measured by AUC0-7d.
AUC0-7d - The area under the plasma concentration-time course profile from time = 0 (dosing) to BTDS removal."|0 to 7 days|Pharmacokinetic Population: All subjects who satisfied the inclusion/exclusion criteria, received both applications of BTDS, and submitted to postbaseline phlebotomy through at least the 72-hour time point of both applications.||pg/mL*h||Standard Error|Mean
832818|NCT01259102|Secondary|Period 1: AUC0-7d.|"Period 1 was the first application of BTDS 10: The time for absorption to return to normal measured by AUC0-7d.
AUC0-7d - The area under the plasma concentration-time course profile from time = 0 (dosing) to BTDS removal."|0 to 7 days|Pharmacokinetic Population: All subjects who satisfied the inclusion/exclusion criteria, received both applications of BTDS, and submitted to postbaseline phlebotomy through at least the 72-hour time point of both applications.||pg/mL*h||Standard Error|Mean
832819|NCT01259102|Primary|Period 2: Cmax0-3d|"Period 2 was the second application of BTDS 10: To determine the minimum application site rest periods that ensured that the reapplication of BTDS to the same site in the deltoid region did not result in increased absorption of the drug as measured by Cmax0-3d.
Cmax0-3d (pg/mL) - The maximum observed concentration taken directly from the plasma concentration-time course profile from time = 0 (dosing) through day 3 (to 72 hours). This was considered an index of maximum (peak) exposure to the study drug."|0 to 3 days|Pharmacokinetic Population: All subjects who satisfied the inclusion/exclusion criteria, received both applications of BTDS, and submitted to postbaseline phlebotomy through at least the 72-hour time point of both applications.||pg/mL||Standard Error|Mean
832820|NCT01259102|Primary|Period 1: Cmax0-3d|"Period 1 was the first application of BTDS 10: To determine the minimum application site rest periods that ensured that the reapplication of BTDS to the same site in the deltoid region did not result in increased absorption of the drug as measured by Cmax0-3d.
Cmax0-3d - The maximum observed concentration taken directly from the plasma concentration-time course profile from time = 0 (dosing) through day 3 (to 72 hours). This was considered an index of maximum (peak) exposure to the study drug."|0 to 3 days|Pharmacokinetic Population: All subjects who satisfied the inclusion/exclusion criteria, received both applications of BTDS, and submitted to postbaseline phlebotomy through at least the 72-hour time point of both applications.||pg/mL||Standard Error|Mean
832821|NCT01259102|Primary|Period 2: AUC0-3d.|"Period 2 was the second application of BTDS 10: To determine the minimum application site rest periods that ensured that the reapplication of BTDS to the same site in the deltoid region did not result in increased absorption of the drug as measured by AUC0-3d.
AUC0-3d - The area under the plasma concentration-time course profile from time = 0 (dosing) through day 3 (to 72 hours)."|0 to 3 days|Pharmacokinetic Population: All subjects who satisfied the inclusion/exclusion criteria, received both applications of BTDS, and submitted to postbaseline phlebotomy through at least the 72-hour time point of both applications.||pg/mL*h||Standard Error|Mean
832822|NCT01259102|Primary|Period 1: AUC0-3d|Period 1 was the first application of BTDS 10: To determine the minimum application site rest periods that ensured that the reapplication of BTDS to the same site in the deltoid region did not result in increased absorption of the drug as measured by AUC0-3d [The area under the plasma concentration-time course profile from time = 0 (dosing) through day 3 (to 72 hours)].|0 to 3 days (72 hours)|Pharmacokinetic Population: All subjects who satisfied the inclusion/exclusion criteria, received both applications of BTDS, and submitted to postbaseline phlebotomy through at least the 72-hour time point of both applications.||pg/mL*h||Standard Error|Mean
832823|NCT01259115|Secondary|The Number of Participants With Adverse Events (AEs) as a Measure of Safety.|Safety assessments consisted of monitoring and recording medical history, physical examinations, vital signs (including temperature, heart rate, blood pressure and respiratory rate), reports of adverse experiences, and laboratory abnormalities (including electrocardiogram [ECG]).|The first day of study drug administration to 30 days after the last dose of study drug.|Safety Population: Safety analyses were performed on all subjects who received at least 1 dose of study drug and for whom at least 1 postdose safety observation was recorded.||participants|||Number
832842|NCT01259245|Primary|SGRQ HKC-Impact|SGRQ HKC -Impact is calculated by dividing the summed weights by the adjusted maximum possible weight for that component and expressing the result as a percentage. SGRQ-impact score from 0 to 100, where zero indicates best health and 100 indicating maximum disability.|6 months post-intervention|intention to treat||units on a scale||Standard Deviation|Mean
832824|NCT01259115|Primary|Cmax of Buprenorphine-3-glucuronide With and Without Ketoconazole|"For buprenorphine-3-glucuronide pharmacokinetic metric, Cmax (maximum observed plasma concentration), log transformed data were analyzed.
Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 17 and 27."|BTDS Days 3, 10, 19, and 26; ketoconazole or placebo Days 9 and 25|The full analysis population for pharmacokinetics was defined as those subjects who received at least 1 dose of study drug and did not have any incidents of emesis for at least 12 hours from dosing during at least 1 period and had at least 1 valid PK metric.||pg/mL||Standard Deviation|Mean
832825|NCT01259115|Primary|AUCinf of Buprenorphine-3-glucuronide With and Without Ketoconazole|"For buprenorphine-3-glucuronide pharmacokinetic metric, AUCinf (the area under the plasma-concentration time course profile from time 0 [dosing] to infinity), log transformed data were analyzed.
Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 17 and 27."|BTDS Days 3, 10, 19, and 26; ketoconazole or placebo Days 9 and 25|The full analysis population for pharmacokinetics was defined as those subjects who received at least 1 dose of study drug and did not have any incidents of emesis for at least 12 hours from dosing during at least 1 period and had at least 1 valid PK metric.|||||
832826|NCT01259115|Primary|AUCt of Buprenorphine-3-glucuronide With and Without Ketoconazole|"For buprenorphine-3-glucuronide pharmacokinetic metric, AUCt (area under the plasma concentration-time curve from hour 0 to the last measurable plasma concentration), log transformed data were analyzed.
Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 17 and 27."|BTDS Days 3, 10, 19, and 26; ketoconazole or placebo Days 9 and 25|The full analysis population for pharmacokinetics was defined as those subjects who received at least 1 dose of study drug and did not have any incidents of emesis for at least 12 hours from dosing during at least 1 period and had at least 1 valid PK metric.||pg/mL*h||Standard Deviation|Mean
832827|NCT01259115|Primary|Cmax of Nor-buprenorphine Glucuronide With and Without Ketoconazole|"For nor-buprenorphine glucuronide pharmacokinetic metric, Cmax (maximum observed plasma concentration), log transformed data were analyzed.
Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 17 and 27."|BTDS Days 3, 10, 19, and 26; ketoconazole or placebo Days 9 and 25|The full analysis population for pharmacokinetics was defined as those subjects who received at least 1 dose of study drug and did not have any incidents of emesis for at least 12 hours from dosing during at least 1 period and had at least 1 valid PK metric.||pg/mL||Standard Deviation|Mean
832828|NCT01259115|Primary|AUCinf of Nor-buprenorphine Glucuronide With and Without Ketoconazole|"For nor-buprenorphine glucuronide pharmacokinetic metrics, AUCinf (the area under the plasma-concentration time course profile from time 0 [dosing] to infinity) log transformed data were analyzed.
Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 17 and 27."|BTDS Days 3, 10, 19, and 26; ketoconazole or placebo Days 9 and 25|The full analysis population for pharmacokinetics was defined as those subjects who received at least 1 dose of study drug and did not have any incidents of emesis for at least 12 hours from dosing during at least 1 period and had at least 1 valid PK metric.||pg/mL*h||Standard Deviation|Mean
832829|NCT01259115|Primary|AUCt of Nor-buprenorphine Glucuronide With and Without Ketoconazole|"For nor-buprenorphine glucuronide pharmacokinetic metrics, AUCt (area under the plasma concentration-time curve from hour 0 to the last measurable plasma concentration), log transformed data were analyzed.
Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 17 and 27."|BTDS Days 3, 10, 19, and 26; ketoconazole or placebo Days 9 and 25|The full analysis population for pharmacokinetics was defined as those subjects who received at least 1 dose of study drug and did not have any incidents of emesis for at least 12 hours from dosing during at least 1 period and had at least 1 valid PK metric.||pg/mL*h||Standard Deviation|Mean
832830|NCT01259115|Primary|Cmax of Nor-buprenorphine With and Without Ketoconazole|"For nor-buprenorphine pharmacokinetic metric, Cmax (maximum observed plasma concentration), log transformed data were analyzed.
Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 17 and 27."|BTDS Days 3, 10, 19, and 26; ketoconazole or placebo Days 9 and 25|The full analysis population for pharmacokinetics was defined as those subjects who received at least 1 dose of study drug and did not have any incidents of emesis for at least 12 hours from dosing during at least 1 period and had at least 1 valid PK metric.||pg/mL||Standard Deviation|Mean
832843|NCT01259245|Primary|SGRQ HKC-Activity|SGRQ HKC-Activity is calculated by dividing the summed weights by the adjusted maximum possible weight for that component and expressing the result as a percentage. SGRQ-Activity score from 0 to 100, where zero indicates best health and 100 indicating maximum disability.|6 months post-intervention|Intention to treat analysis||units on a scale||Standard Deviation|Mean
833984|NCT01263496|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 20).|The change between the value of fasting plasma glucose collected at week 20 and fasting plasma glucose collected at baseline.|Baseline and Week 20.|Values are Summary Statistics.||mg/dL||Standard Deviation|Mean
832831|NCT01259115|Primary|AUCinf of Nor-buprenorphine With and Without Ketoconazole|"For nor-buprenorphine pharmacokinetic metric, AUCinf (the area under the plasma-concentration time course profile from time 0 [dosing] to infinity).
Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 17 and 27."|BTDS Days 3, 10, 19, and 26; ketoconazole or placebo Days 9 and 25|The full analysis population for pharmacokinetics was defined as those subjects who received at least 1 dose of study drug and did not have any incidents of emesis for at least 12 hours from dosing during at least 1 period and had at least 1 valid PK metric.||pg/mL*h||Standard Deviation|Mean
832832|NCT01259115|Secondary|CYP3A4 Inhibition by Observation of Plasma Nor-buprenorphine Production Assessed by the Erythromycin Breath Test.|As part of subject screening, Erythromycin Breath Tests (EBT) were done on all potential subjects (enrolled population). CYP 3A4 inhibition was calculated by taking the difference of the baseline 14C erythromycin metabolism, subtracting the 14C erythromycin metabolism during ketoconazole treatment, dividing this difference by the baseline 14C erythromycin metabolism, and multiplying by 100 to express results in the form of percent inhibition. CYP3A4 inhibition was only done when subjects were on ketoconazole.|One time at screening and one time during ketoconazole treatment|Enrolled Population: All subjects who participated in the study. CYP3A4 Inhibition was only done when subjects were on Ketoconazole.||Percentage of participants||Standard Deviation|Mean
832833|NCT01259115|Primary|AUCt of Nor-buprenorphine With and Without Ketoconazole|"For nor-buprenorphine pharmacokinetic metric, AUCt (area under the plasma concentration-time curve from hour 0 to the last measurable plasma concentration).
Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 17 and 27."|BTDS Days 3, 10, 19, and 26; ketoconazole or placebo Days 9 and 25|The full analysis population for pharmacokinetics was defined as those subjects who received at least 1 dose of study drug and did not have any incidents of emesis for at least 12 hours from dosing during at least 1 period and had at least 1 valid PK metric.||pg/mL*h||Standard Deviation|Mean
832834|NCT01259115|Primary|Cmax of Buprenorphine With and Without Ketoconazole.|"Cmax (maximum observed plasma concentration) of buprenorphine transdermal patch 10 with and without ketoconazole 200 mg oral tablets twice daily,
Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 17 and 27."|BTDS Days 3, 10, 19, and 26; ketoconazole or placebo Days 9 and 25|The full analysis population for pharmacokinetics was defined as those subjects who received at least 1 dose of study drug and did not have any incidents of emesis for at least 12 hours from dosing during at least 1 period and had at least 1 valid PK metric.||pg/mL||Standard Deviation|Mean
832835|NCT01259115|Primary|AUCinf of Buprenorphine With and Without Ketoconazole.|"AUCinf (the area under the plasma-concentration time course profile from time 0 [dosing] to infinity) of buprenorphine transdermal patch 10 with and without ketoconazole 200 mg oral twice daily.
Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 17 and 27."|BTDS Days 3, 10, 19, and 26; ketoconazole or placebo Days 9 and 25|The full analysis population for pharmacokinetics was defined as those subjects who received at least 1 dose of study drug and did not have any incidents of emesis for at least 12 hours from dosing during at least 1 period and had at least 1 valid pharmacokinetic metric.||pg /mL•h||Standard Deviation|Mean
832836|NCT01259115|Primary|AUCt of Buprenorphine With and Without Ketoconazole.|"AUCt (area under the plasma concentration-time curve from hour 0 to the last measurable plasma concentration) of buprenorphine transdermal patch 10 with and without ketoconazole 200 mg oral twice daily.
Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (200 mg orally twice daily) or Ketoconazole placebo (orally twice daily) between days 17 and 27."|BTDS Days 3, 10, 19, and 26; ketoconazole or placebo Days 9 and 25|The full analysis population for pharmacokinetics was defined as those subjects who received at least 1 dose of study drug and did not have any incidents of emesis for at least 12 hours from dosing during at least 1 period and had at least 1 valid pharmacokinetic metric.||pg/mL*h||Standard Deviation|Mean
832837|NCT01259245|Secondary|FEV1% Pred|Pred FEV1 percent predicted normal values;measured using spirometry|6 months post-intervention|Intention to treat||percentage of FEV1 predicted||Standard Deviation|Mean
832838|NCT01259245|Secondary|FEV1|Forced expiratory volume in one second, measured in liters, component of lung function test measured by spirometry|6 months post-intervention|Intention to treat analysis||liters||Standard Deviation|Mean
832839|NCT01259245|Secondary|FVC|Forced vital capacity, measured in liters, component of lung function parameters measured by spirometry|6 months post intervention|Intention to treat analysis||liters||Standard Deviation|Mean
832840|NCT01259245|Secondary|6 MWT in Meters|The 6 minute walking test ( 6MWT) was conducted according to protocol recommended by American Thoracic Society (ATS) guidelines to measure functional exercise capacity.This test measured the self paced distance in meters that a patient could quickly walk on a flat, hard surface in a period of 6 minutes.|6 months post-intervention|Intention to treat analysis||meters||Standard Deviation|Mean
832841|NCT01259245|Primary|SGRQ HKC Total|SGRQ HKC-Total is calculated by summing all positive responses in the questionnaire and expressing the result as a percentage of the toal weight for the questionnaire. A total score is calculated from all three components. The SGRQ-total score ranged from 0 to 100, where zero indicates best health and 100 indicating maximum disability.|6 months post-intervention|Intention to treat analysis||units on a scale||Standard Deviation|Mean
832844|NCT01259245|Primary|SGRQ HKC-Symptoms|SGRQ HKC-Symptoms is calculated by dividing the summed weights by the adjusted maximum possible weight for that component and expressing the result as a percentage. SGRQ-Symptoms score ranged from 0 to 100, where zero indicates best health and 100 indicating maximum disability.|6 months post-intervention|Intention to treat analysis||units on a scale||Standard Deviation|Mean
832845|NCT01259245|Primary|Self- Efficacy : Self-Efficacy for Managing Shortness of Breath ( SEMSOB)|The SEMSOB is a single question 1-10 scale, valid and reliable instrument that measures patients’ overall confidence in keeping breathing difficulties from interfering with what they want to do with higher score indicating greater self efficacy.|Change in SEMSOB at 6 months post-intervention|Intention to treat||units on a scale||Standard Deviation|Mean
832846|NCT01259245|Primary|Self Efficacy :COPD Self Efficacy Scale (CSES)|"34 item questionnaire consisting of likert scale with 5 responses ranging from 1 indicating  not at all confident to 5 indicating  very confident with higher scores representing higher self efficacy. In this study , we used the rating score in the analysis as some items were considered non-applicable in some cases. Rating score from 0.2 to 1 with 0.2 as not at all confident and 1 as very confident. The validated Chinese version of CSES was also used"|Change in CSES at 6 months post-intervention|Intention to treat was used in the analysis||rating score of 0.2 to 1||Standard Deviation|Mean
832847|NCT01259284|Primary|Incidences of Atrial Fibrillation During First 4 Days After Lung Resection|New onset of sustained (15 min or >) or clinically significant (requiring intervention) atrial fibrillation (AF) during first 4 days post surgery as defined by on American College of Cardiology and American Heart Association Physician Consortium.|Baseline to 4 days post surgery|Analysis was to be per protocol. There is no analysis due to an inadequate number of enrolled participants in study which resulted in early termination.|||||
832848|NCT01259297|Secondary|Number of Participants With Total Mortality in Aliskiren Based Regimen Versus Non-aliskiren Based Regimen|The total mortality endpoint was defined as time to death from any cause. Total mortality analysis used the date of last follow-up including the washout period as the censoring date.|End of study (209 days (median))|Full Analysis set. 1759 patients were randomized as against the originally planned 11,000. The duration of study follow-up was 209 days (median) as against the planned follow-up of average 5 years. These low numbers significantly limit interpretation of the results.||Participants|||Number
832849|NCT01259297|Other Pre-specified|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)|Mean sitting diastolic blood pressure (msDBP) is the average of 2 sitting DBP measurements (2 minutes apart). Since each patient had their final follow-up visit at a different time in the trial, these measurements were classified as falling into the 6 week, 6 month, or 12 month measurement period. All available blood pressures were sorted within these periods and the last value within each time range used for analysis. At each timepoint, a patient must have both baseline and postbaseline values to be included in the analysis.|Baseline (BL), 6 week, 6 month and 12 month|Full analysis Set : All randomized patients, regardless of receiving study medication. n=number of patients with non-missing assessments at baseline and each post-baseline visit.||mmHg||Standard Error|Least Squares Mean
832850|NCT01259297|Secondary|Number of Participants With Renal Dysfunction in Aliskiren Based Regimen Versus Non-Aliskiren Based Regimen|"The renal dysfunction (composite endpoint) was defined as the first occurrence of either of the following:
End-stage renal disease [ESRD] requiring dialysis or transplantation
Doubling of serum creatinine and reaching an eGFR < 45 ml/min/1.73 m^2."|End of study (209 days (median))|Full Analysis set. 1759 patients were randomized as against the originally planned 11,000. The duration of study follow-up was 209 days (median) as against the planned follow-up of average 5 years. These low numbers significantly limit interpretation of the results.||participants|||Number
832851|NCT01259297|Secondary|Percentage of Participants With Standard Assessment of Global Activities in the Elderly (SAGE) Dimensions (Part II)|"Decline in ability to perform everyday activities independently was measured primarily by using the Standard Assessment of Global Activities in the Elderly (SAGE) scale. The SAGE was comprised of 15 questions, each describing an activity. Patient had to indicate how much difficulty he/she had encountered in performing the activity in the last month. Each question’s score ranges from 0 (No difficulty) to 3 (difficulty levels were mild (score = 1), moderate (score =2) and severe (score=3)).
Part II of SAGE included 2 dimensions:
Normal if the scores of all SAGE questions is 0 (i.e., No difficulty)
Mobility Only if scores of both SAGE questions 11 and 12 are 0"|End of study (209 days [median])|Full Analysis Set. Number of patients with all SAGE questions non-missing for the specific visit are included in this population. Due to the sparse post-baseline data following early termination of the study, this analysis was not performed as planned in protocol.Hence, no meaningful conclusion could be drawn.||percentage of participants|||Number
832852|NCT01259297|Primary|Number of Participants With Composite Cardiovascular Endpoints in Aliskiren+Amlodipine/HCTZ Group Versus All Placebo Group|The composite CV endpoint is based on the following first adjudicated events: CV death, non-fatal MI,non-fatal stroke, significant heart failure|End of study (209 days (median))|Full Analysis set. 1759 patients were randomized as against the originally planned 11,000. A total of 25 primary CV composite endpoints had accrued during median follow-up of 209 days versus planned 2000 primary endpoints during planned follow-up of average 5 years. These low numbers significantly limit interpretation of the results.||participants|||Number
832853|NCT01259297|Other Pre-specified|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)|Mean sitting systolic blood pressure (msSBP) is the average of 2 sitting SBP measurements (2 minutes apart). Since each patient had their final follow-up visit at a different time in the trial, these measurements were classified as falling into the 6 week, 6 month, or 12 month measurement period. All available blood pressures were sorted within these periods and the last value within each time range used for analysis. At each timepoint, a patient must have both baseline and postbaseline values to be included in the analysis.|Baseline (BL), 6 week, 6 month and 12 month|Full analysis Set : All randomized patients, regardless of receiving study medication. n=number of patients with non-missing assessments at baseline and each post-baseline visit.||mmHg||Standard Error|Least Squares Mean
832868|NCT01259427|Primary|Maryland Assessment of Recovery for Serious Mental Illness Scale (Recovery)|The Maryland Assessment of Recovery in Serious Mental Illness is a self-report measure of recovery in people with serious mental illness. A total score was calculated by summing item responses (range=25 to 125), with higher total scores indicating greater self-reported recovery.|~3 1/2 months (post-treatment)|||units on a scale||Standard Deviation|Mean
832854|NCT01259297|Secondary|Change From Baseline to End of Study in Standard Assessment of Global Activities in the Elderly (SAGE) Dimensions (Part I)|"Decline in ability to perform everyday activities independently was measured primarily by using the Standard Assessment of Global Activities in the Elderly (SAGE) scale. The SAGE comprised of 15 questions, each describing an activity. Patient had to indicate how much difficulty he/she had encountered in performing the activity in last month. Each question’s score ranges from 0 (No difficulty) to 3 (difficulty levels were mild (score = 1), moderate (score =2) and severe (score=3)). Part I of SAGE included 4 dimensions:
Community Cognition (maximum of scores of questions 1 to 6);
Instrumental Activities of daily Living (IADL) (maximum of scores of questions 7 to 10);
Mobility (maximum of scores of questions 11 and 12);.
Basic Activities of daily Living (ADL) (maximum of scores of questions 13 to 15) Each dimension’s total score ranged from 0 to 3. 0=best, 3=worst A negative change in value from baseline means improvement in the ability to perform everyday activities."|Baseline, End of study (209 days [median])|Full Analysis Set: Due to the sparse post-baseline data following early termination of the study, this analysis was not performed as planned in protocol.Hence, no meaningful conclusion could be drawn. Patients who completed both baseline and post-baseline SAGE questionnaires (Part II) were included in this analysis.||units on a scale||Standard Deviation|Mean
832855|NCT01259297|Primary|Number of Participants With Composite Cardiovascular Endpoints in Aliskiren Based Regimen Versus Non-Aliskiren Based Regimen|The composite CV endpoint is based on the following first adjudicated events: CV death, non-fatal MI,non-fatal stroke, significant heart failure|End of study (209 days (median))|Full Analysis set. 1759 patients were randomized as against the originally planned 11,000. A total of 25 primary CV composite endpoints had accrued during median follow-up of 209 days versus planned 2000 primary endpoints during planned follow-up of average 5 years. These low numbers significantly limit interpretation of the results.||participants|||Number
832856|NCT01259375|Secondary|Differential Response to Amurbicin Among Certain Histologic Subtypes of Sarcoma.|Per response evaluation criteria in solid tumors criteria (RECIST 1.1) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR) >= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|48 months|||participants|||Number
832857|NCT01259375|Secondary|Quality of Response With Radiographic Evaluation Using Both Response Evaluation Criteria In Solid Tumors (RECIST) and Choi Criteria.|Per response evaluation criteria in solid tumors criteria (RECIST 1.1) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR) >= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Exploratory CT evaluations according to Choi response criteria will be also performed and correlated with RECIST response.|48 months|This exploratory objective was not assessed.|||||
832858|NCT01259375|Secondary|Overall Survival|This variable reviews the percentage of Overall Survival at 24 months and presents the percentage of participants who survived at 2 years.|two years|||percentage of participants||95% Confidence Interval|Number
832859|NCT01259375|Secondary|Number of Participants With Serious Adverse Events||4 months|One patient discontinued study treatment after the first cycle due to side effects and was not evaluable for response, but was evaluable for safety and toxicity.||participants who experienced an SAE|||Number
832860|NCT01259375|Primary|Progression Free Survival|Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.1) for target lesions and assessed by CT; time elapsed between treatment initiation and tumor progression or death. In target lesions, progression is defined per Response Evaluation Criteria in Solid Tumors Criteria (RECIST 1.1) as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. In non-target lesions, progression is defined via RECIST v 1.1 as the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|six months|||percentage of pt with 6 mnth PFS||95% Confidence Interval|Number
832861|NCT01259375|Primary|Response Rate for Amrubicin in Patients With Metastatic or Advanced Sarcoma as First Line Therapy.|Per response evaluation criteria in solid tumors criteria (RECIST 1.1) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR) >= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|48 months|One patient discontinued study treatment after the first cycle due to side effects and was not evaluable for response.||percentage of pt with a partial response||95% Confidence Interval|Number
832862|NCT01259401|Primary|Sleep Efficiency|Percentage of time asleep while in bed estimated by actigraphy.|4-month follow-up|Two SIP subjects had missing data for this variable.||percentage of time in bed asleep||95% Confidence Interval|Mean
832863|NCT01259401|Primary|Sleep Efficiency|Percentage of time asleep while in bed estimated by actigraphy|End of 4-week intervention|Two SIP subjects had missing data for this variable.||percentage of time in bed spent asleep||95% Confidence Interval|Mean
832864|NCT01259427|Secondary|Social Engagement/Withdrawal|The total score of the Social Engagement/Withdrawal subscale of the Social Functioning Scale was used to measure social engagement. The total score ranges from 0 to 15 with higher scores indicating greater social engagement.|~3 1/2 months (post-treatment)|||unit on a scale||Standard Deviation|Mean
832865|NCT01259427|Secondary|Quality of Life|The Satisfaction with Life in General item from the Brief Quality of Life Scale was used to assess self-reported life satisfaction. The item is rated on a 7-point scale that ranges from terrible to delighted (range=1 to 7), with greater scores indicating more satisfaction.|~3 1/2 months (post-treatment)|||units on a scale||Standard Deviation|Mean
832866|NCT01259427|Primary|Sense of Belonging Instrument (Belonging)|The Sense of Belonging Instrument was used to measure perceived belongingness. The measure includes two subscales: the psychological experience of belonging (SOBI-P) and antecedents that foster belonging (SOBI-A). An average of the sum of the items in each subscale were used to calculate the total score for that subscale. The total score of the SOBI-P ranges from 18 to 72, with higher scores indicating less experienced belonging. The total score of the SOBI-A ranges from 14-56 with higher score indicating greater antecedents that foster belonging.|~3 1/2 months (post-treatment)|||units on a scale||Standard Deviation|Mean
832867|NCT01259427|Primary|General Self-Efficacy Scale|The General Self-efficacy measure was used to measure of self-efficacy. A total score was calculated by averaging the responses on the items (range=1 to 5), with higher scores indicating greater self-efficacy.|~3 1/2 months (post-treatment)|||unit on a scale||Standard Deviation|Mean
832869|NCT01259427|Primary|Internalized Stigma of Mental Illness Inventory (Internalized Stigma)|The Internalized Stigma of Mental Illness Inventory was used to measure of internalized or self-stigma. A total score is calculated by taking an average of the responses on the items (range=1 to 4). Higher total scores indicate greater internalized stigma.|~3 months (post-treatment)|||units on a scale||Standard Deviation|Mean
832870|NCT01259440|Primary|Treatment Adherence|Nightly CPAP adherence measured over the two-month period .|2 months|||hours/night||Standard Deviation|Mean
832871|NCT01259466|Secondary|Percent Weight Change|% Weight change: ((post-treatment weight - pre-treatment weight)/ pre-treatment weight) * 100|Post-treatment (12 weeks)|||Percent weight change||Standard Deviation|Mean
832872|NCT01259466|Primary|Number of Participants With Verified Smoking Cessation (Abstinence)|Continuous abstinence during the last 14 days of treatment, confirmed by biologically verified abstinence (CO level <10ppm)|Post-treatment (12-weeks)|||participants|||Number
832873|NCT01259492|Secondary|Change From Baseline Period 3 (Baseline 2) to End of Period 3 in ASRS Total Score by Treatment|"The ASRS is a self-rating scale designed to assess ADHD symptoms in adults and is now part of the World Health Organization Composite International Diagnostic Interview. It consists of 18 items written to reflect the DSM-IV diagnostic criteria for ADHD and are rated from 0 (Never) to 4 (Very often). The total score ranges from 0 to 72."|Baseline 2 to end of Period 3 (end of withdrawal period 40 weeks)|Full Analysis Set for Period 3 (FAS P3) – all re-randomized patients who take one dose of study medication in period 3. Patients will be assigned to their re-randomized treatment; Ritalin (pooled doses) or placebo.||Units on a scale||Standard Deviation|Mean
832874|NCT01259492|Secondary|Change From Baseline Period 3 (Baseline 2) to End of Period 3 in Conners Adult ADHD Rating Scales Observer: Short Version (CAARS-O:S:) Total Score by Treatment|CAARS is an instrument to assess ADHD symptoms and behaviors in adults. This study utilizes the Observer Short Version (CAARS-O: S), consisting of 26 items and 6 subscales: Inattention/Memory Problems, Hyperactivity/Restlessness, Impulsivity/Emotional Lability, Problems with Self-Concept, ADHD Index (to distinguish ADHD adults from non-clinical adults), and Inconsistency Index (to identify random or careless responding) and is rated by someone close to the patient in their daily life such as a spouse, friend, or coworker. The observer is asked to notice the patient carefully and decide how much or how frequently each of the 26 items of the scale describes the patient recently. The response to every question in increasing order of severity is “not at all, never = 0; Just a little, once in a while = 1; Pretty much, often = 2; Very much, very frequently = 3”. The total score combined from all the 26 items ranges from 0 to 88.|Baseline 2 to end of Period 3 (end of withdrawal period 40 weeks)|Full Analysis Set for Period 3 (FAS P3) – all re-randomized patients who take one dose of study medication in period 3. Patients will be assigned to their re-randomized treatment; Ritalin (pooled doses) or placebo.||Units on a scale||Standard Deviation|Mean
832875|NCT01259492|Secondary|Number of Patients With Worsening on CGI-S Scale From Baseline Period 3 (Baseline 2) to End of Period 3 by Treatment|CGI-S assesses the patient’s current illness state. CGI-S consists of 7 ratings that range from 1 = “normal, not at all ill” , 2 = “borderline mentally ill”, 3 =” mildly ill”, 4 = “moderately ill”, 5 = “markedly ill”, 6 = “severely ill”, 7 = “among the most extremely ill patients”|Baseline 2 to end of Period 3 (end of withdrawal period 40 weeks)|Full Analysis Set for Period 3 (FAS P3) – all re-randomized patients who take one dose of study medication in period 3. Patients will be assigned to their re-randomized treatment; Ritalin (pooled doses) or placebo. Evaluable patients with both baseline 2 and post-baseline (end of week 40) assessments were included.||Participants|||Number
832876|NCT01259492|Secondary|Number of Patients With Worsening on CGI-I Scale From Baseline Period 3 (Baseline 2) to End of Period 3 by Treatment|On the CGI-I scale, a lower score reflects greater improvement between 1 and 3, a score of 4 is “no change”, scores higher than 4 reflect worsening. The CGI-I consists of 7 ratings that range from 1 = “Very much improved” to 7 =“Very much worse”. Improvement on the CGI-I scale is defined as a visit rating of 1 “very much improved” or 2 “much improved” on the CGI-I scale.|Baseline 2 to end of Period 3 (end of withdrawal period 40 weeks)|Full Analysis Set for Period 3 (FAS P3) – all re-randomized patients who take one dose of study medication in period 3. Patients will be assigned to their re-randomized treatment; Ritalin (pooled doses) or placebo. Evaluable patients with both baseline 2 and post-baseline (end of week 40) assessments were included.||participants|||Number
832877|NCT01259492|Secondary|Change From Baseline Period 3 (Baseline 2) to End of Period 3 on SDS Total Score by Treatment|The Sheehan Disability Scale (SDS) is a self-rating scale designed to assess the extent to which the patient’s work social life/leisure activities and home life are impaired by his or her symptoms. The scale generates 4 scores: a work disability score, a social life disability score, a family life disability score and a total score. To get a total score the 3 individual scores (work: social life: family life) are totaled. The maximum possible score is 30 The higher the score, the more “impaired” a patient’s work, social life, family life is.|Baseline 2 to end of Period 3 (end of withdrawal period 40 weeks)|Full Analysis Set for Period 3 (FAS P3) – all re-randomized patients who take one dose of study medication in period 3. Patients will be assigned to their re-randomized treatment; Ritalin (pooled doses) or placebo.||Units on a Scale||Standard Deviation|Mean
832878|NCT01259492|Secondary|Change From Baseline Period 3 (Baseline 2) to End of Period 3 on DSM-IV Attention-Deficit/Hyperactivity Disorder Rating Scale ADHD RS Total Score by Treatment|The ADHD-RS-IV is an 180 item clinician rated scale to assess ADHD by DSM-IV-TR, defined criteria using symptom terminology appropriate for the adult population. Each item pertains to inattention (odd-numbered) or hyperactivity/impulsivity (even-numbered) and is scored on a scale of 0 (no symptoms) to 3 (severe symptoms). A total added score can range from 0-54.|Baseline 2 to end of Period 3 (end of withdrawal period 40 weeks)|Full Analysis Set for Period 3 (FAS P3) – all re-randomized patients who take one dose of study medication in period 3. Patients will be assigned to their re-randomized treatment; Ritalin (pooled doses) or placebo.||Units on a Scale||Standard Deviation|Mean
832886|NCT01259596|Secondary|Changes From Baseline in Generalized Anxiety Disorder-7 (GAD-7) to Week 13|Diagnostic and Statistical Manual of Mental Disorders, IV edition (DSM-IV0) symptoms of Generalized Anxiety Disorder; scores range from 0 to 24 with higher scores indicating greater symptoms of GAD; higher score represents worse outcome|baseline to week 13|||units on a scale||95% Confidence Interval|Mean
832887|NCT01259596|Secondary|Insomnia Severity Index (ISI)|self-report symptoms of insomnia; scores range from 0 to 28 with higher scores indicating greater symptoms of sleep disturbance; higher score represents worse outcomes|week 13||||||
832879|NCT01259492|Secondary|Number of Participants With Clinical Global Impression – Improvement Scale Severity of Illness (CGI-S) Rating at the End of Period 2 (Visit 13/ Week 14)|CGI-S assesses the patient’s current illness state. CGI-S consists of 7 ratings that range from 1 = “normal, not at all ill” , 2 = “borderline mentally ill”, 3 =” mildly ill”, 4 = “moderately ill”, 5 = “markedly ill”, 6 = “severely ill”, 7 = “among the most extremely ill patients”|Baseline 1 to End of Period 2 (Week 14)|Full Analysis Set for Period 2 (FAS P2) – all randomized patients who took one dose of study medication in Period 2; Patients with CGI-S assessment both at Baseline 1 and Period 2 was included.||number of participants|||Number
832880|NCT01259492|Secondary|Number of Participants With Clinical Global Impression – Improvement Scale (CGI-I) Rating at the End of Period 2 (Visit 13/ Week 14)|CGI-I assesses the overall change of illness relative to baseline. CGI-I consists of 7 ratings that range from 1 = “very much improved”, 2 = “much improved”, 3 = “minimally improved”, 4 = “no change from baseline”, 5 = “minimally worse”, 6 = “much worse” 7 = “very much worse”|Baseline 1 to End of Period 2 (Week 14)|Full Analysis Set for Period 2 (FAS P2) – all randomized patients who took one dose of study medication in Period 2 Patients with CGI-I assessment both at Baseline 1 and Period 2 was included.||number of participants|||Number
832881|NCT01259492|Secondary|Change From Baseline 1 in DSM-IVADHD RS Total Score, SDS Total Score, The Conners’ Adult ADHD Rating Scale Observer Short Version (CAARS-O:S) Total Score and Adult Self-Report Scale (ASRS) Total Score at the End of Period 2 (Visit 13/ Week 14)|"DSM-IV ADHD RS consists of 18 items directly adapted from the ADHD symptom list according to the DSM-IV. The SDS is a five-item, self-rated questionnaire that has been used widely in clinical trials and observational studies. CAARS-O: S consists of 26 items and 6 subscales: Inattention/Memory Problems, Hyperactivity/Restlessness, Impulsivity/Emotional Lability, Problems with Self-Concept, ADHD Index, and Inconsistency Index and is rated by someone close to the patient in their daily life such as a spouse, friend, or coworker. The Adult Self-Report Scale (ASRS) is a self-rating scale designed to assess Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms. The 18 items are written to reflect the DSM-IV diagnostic criteria for ADHD and are rated from 0 (Never) to 4 (Very often)."|Baseline 1 to End of Period 2 (Week 14)|Full Analysis Set for Period 2 (FAS P2) – all randomized patients who took one dose of study medication in Period 2||Score on Scale||Standard Deviation|Mean
832882|NCT01259492|Secondary|Percentage of Patients With Improvement on Clinical Global Impression – Improvement Scale (CGI-I) From Baseline Period 1 (Baseline 1) to End of Period 1|On the CGI-I scale, a lower score reflects greater improvement between 1 and 3, a score of 4 is “no change”, scores higher than 4 reflect worsening. The CGI-I consists of 7 ratings that range from 1 = “Very much improved” to 7 =“Very much worse”. Improvement on the CGI-I scale is defined as a visit rating of 1 “very much improved” or 2 “much improved” on the CGI-I scale. Percentage has been calculated from the evaluable patients (N) as Percentage = n/N * 100.|Baseline 1 to End of Period 1 (Week 9)|Full Analysis Set for Period 1 (FAS P1) – all randomized patients who take one dose of study medication in period 1. Patients will be assigned to their randomized fixed dose. Evaluable patients with both baseline and post-baseline (end of week 9) assessments were included.||Percentage of Patients|||Number
832883|NCT01259492|Primary|Percentage of Participants With Treatment Failures During Period 3|Treatment failure is defined as: 100×(DSM-IV ADHD RS total score during Period 3 – DSM-IV ADHD RS total score at re-randomization (visit 13))/DSM-IV ADHD RS total score at re-randomization (visit 13) >= 30% AND 100×(DSM-IV ADHD RS total score during Period 3 – DSM-IV ADHD RS total score at randomization (visit 2))/DSM-IV ADHD RS total score at randomization (visit 2) > - 30%. The ADHD-RS-IV is an 180item clinician rated scale to assess ADHD by DSM-IV-TR, defined criteria using symptom terminology appropriate for the adult population. Each item pertains to inattention (odd-numbered) or hyperactivity/impulsivity (even-numbered) and is scored on a scale of 0 (no symptoms) to 3 (severe symptoms). A total added score can range from 0-54|Baseline Period 1 (Baseline 1) and Baseline Period 3 (Baseline 2) to End of Week 40|Full Analysis Set for Period 3 (FAS P3) – all re-randomized patients who take one dose of study medication in period 3. One patient in Ritalin LA 80mg did not have post baseline 2 measurements and was not included in the categories under without imputation.||Percentage of participants|||Number
832884|NCT01259492|Primary|Change From Baseline Period 1 (Baseline 1) to End of Period 1 on Sheehan Disability Scale (SDS) Total Score by Treatment|SDS, a 5-self-rated questionnaire to measure the extent a pt’s disability due to an illness/health problem interferes with work/school, social life/leisure, family life/home. First 3 items, pts are asked how their symptoms disrupted their reg. activities over the past 7d in ea. using a scale from 0(not at all)-10(extremely) Ea. subscale(work disability, social life disability, family life disability) can be scored independently or combined into a total score(sum of the non-missing responses for items 1-3)from 0-30,higher scores indicate significant functional impairmt. Subscale scores >5 suggest impairment in that subscale area. Final 2 items ask pts about the # of days their symptoms caused them to miss school/work and # of days their symptoms caused them to be underproductive at school/work.(These items were not included in the total score.) Before responding to SDS items 1-3, pts were verbally instructed to recall the past 7d, items 4-5 refer to the last week w/in the item wording.|Baseline 1 to End of Period 1 (Week 9)|Full Analysis Set for Period 1 (FAS P1) – all randomized patients who take one dose of study medication in period 1. Patients will be assigned to their randomized fixed dose. Patients with both baseline and post-baseline (end of week 9) assessments were included.||Units on a Scale||Standard Deviation|Mean
832885|NCT01259492|Primary|Change From Baseline of Period 1 (Baseline 1) to End of Period 1 on Attention-Deficit/Hyperactivity Disorder Rating Scale (DSM-IV ADHD RS) Total Score by Treatment|"Attention-Deficit/Hyperactivity Disorder Rating Scale (DSM-IV ADHD RS) total score consists of 18 items directly adapted from the ADHD symptom list according to the DSM-IV. The DSM-IV ADHD RS total score was calculated as the sum of the Inattentive and the Hyperactive-Impulsive subscores. The 18 items are rated from 0 (Never) to 4 (Very often). The total score ranges from 0(least symptomatic) to 72 (most symptomatic). Decrease in the DSM-IV ADHD RS total score indicates improvement, therefore a greater decrease (change at Final Visit compared to baseline) indicates a greater improvement in ADHD symptoms. 30% improvement: 100×(DSM-IV ADHD RS total score during Period 1 – DSM-IV ADHD RS total score at randomization(visit 2))/DSM-IV ADHD RS total score at randomization (visit 2) <= - 30%."|Baseline 1 to End of Period 1 (Week 9)|Full Analysis Set for Period 1 (FAS P1) – all randomized patients who take one dose of study medication in period 1. Patients will be assigned to their randomized fixed dose. Patients with both baseline and post-baseline (end of week 9) assessments were included.||Units on a Scale||Standard Deviation|Mean
832888|NCT01259596|Secondary|Form (36) Health Survey (SF-36) to Week 13|physical and emotional health related quality of life; The SF-36 is a self-report measure of health-related quality of life (HRQL) consisting of 36 items that form 8 subscales: physical functioning, role limitations due to physical health problems, role limitations due to emotional health problems, social functioning, freedom from pain, energy, emotional well-being, and general health perceptions. These 8 subscales are also combined into two domains: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). All of these scales range from 0 (maximum impairment) to 100 (no impairment). A lower score represents worse outcome.|week 13||||||
832889|NCT01259596|Secondary|Pepper Center Tool for Disability (PCT-D)|self report measure of perceived difficulties with mobility and performing basic and advanced activities of daily living; the scale consists of 19 items; scores range from 19 to 114, with higher scores indicating more disability. Higher scores represent worse outcome.|week 13||||||
832890|NCT01259596|Secondary|Changes From Baseline in Beck Depression Inventory (BDI) at 13 Weeks|self report measure of depressive symptoms; scores range from 0 to 63, with a higher score representing higher levels of depressive symptoms Higher scores represent worse outcome.|baseline to week 13|||units on a scale||95% Confidence Interval|Mean
832891|NCT01259596|Primary|Changes From Baseline in Hamilton Anxiety Rating Scale (HAM-A) at Week 13|interviewer-rated severity of anxiety symptoms; the scores range from 0 to 56, with higher scores representing higher severity of anxiety. Higher scores represent worse outcome.|baseline to week 13|||units on a scale||95% Confidence Interval|Mean
832892|NCT01259596|Primary|Changes From Baseline in Penn State Worry Questionnaire (PSWQ-A) at Week 13|self-reported severity and frequency of worry the scores range from 8 to 40, with higher scores representing higher severity of worry. Higher scores represent worse outcome.|baseline to week 13|||units on a scale||95% Confidence Interval|Mean
832893|NCT01259713|Secondary|Percentage of Participants With Complete Remission at the End of Remission Induction|This endpoint was to evaluate the potential impact of IFI prevention on the efficacy of remission-induction chemotherapy for ALL.|During remission-induction chemotherapy (average 7 weeks)|ITT Analysis Set||percentage of participants|||Number
832894|NCT01259713|Secondary|Time From Beginning of Remission-induction Chemotherapy Until the Beginning of Consolidation Therapy|This endpoint was to evaluate the potential impact of IFI prevention on the efficacy of remission-induction chemotherapy for ALL.|During remission-induction chemotherapy (average 7 weeks)|ITT Analysis Set||days||Inter-Quartile Range|Median
832895|NCT01259713|Secondary|Percentage of Participants Who Died Due to Fungal Infection; Causality as Assessed by the Investigator.||During remission-induction chemotherapy (average 7 weeks)|ITT Analysis Set||percentage of participants|||Number
832896|NCT01259713|Secondary|Percentage of Participants Who Died Due to Fungal Infection; Causality as Assessed by the IDRB.||During remission-induction chemotherapy (average 7 weeks)|ITT Analysis Set||percentage of participants|||Number
832897|NCT01259713|Secondary|Percentage of Participants Requiring Antifungal Treatment During Remission-Induction Chemotherapy||During remission-induction chemotherapy (average 7 weeks)|ITT Analysis Set||percentage of participants|||Number
832898|NCT01259713|Secondary|Time to Diagnosis of Proven or Probable IFIs According to the EORTC/MSG Criteria, as Assessed by the IDRB.|Time to diagnosis of proven or probable IFIs is presented as the median (Q1,Q3) days to diagnosis of those participants who experienced a proven or probable IFI. Median was not reached if < 50% of participants had an event; Q1 was not reached if < 25% of participants had an event; Q3 was not reached if < 75% of participants had an event.|During remission-induction chemotherapy (average 7 weeks)|ITT Analysis Set||days||Inter-Quartile Range|Median
832899|NCT01259713|Secondary|Percentage of Participants Diagnosed With Proven or Probable IFIs According to the EORTC/MSG Criteria, as Assessed by the Investigator||During remission-induction chemotherapy (average 7 weeks)|ITT Analysis Set||percentage of participants|||Number
832900|NCT01259713|Secondary|Percentage of Participants With Pulmonary Infiltrates According to the Central Image Reader||During remission-induction chemotherapy (average 7 weeks)|ITT Analysis Set||percentage of participants|||Number
832901|NCT01259713|Primary|Percentage of Participants With Proven or Probable IFIs During Remission-induction Chemotherapy for Acute Lymphoblastic Leukemia (ALL)|"Diagnoses of proven or probable invasive fungal infections (IFI) were assessed according to European Organization for Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG) criteria by the independent data review board (IDRB) who were blinded to treatment assignment.
The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy."|During remission-induction chemotherapy (average 7 weeks)|Intent-to-Treat (ITT) Analysis Set: participants in the safety analysis set who had no major violations of entrance criteria.||percentage of participants|||Number
832902|NCT01259726|Secondary|Time to First CDI Recurrence|CDI recurrence was defined as at least 1 event characterized by ALL of the following: >=3 unformed (loose or watery) stools within 24 hours (data derived from Diarrhea CRF page which was to be completed for any clinical event of diarrhea or loose/watery stool occurring between Day 1 and Week 6); a positive C. difficile stool assay, or pseudomembranes on endoscopy/surgery; and no other likely cause of the diarrhea in the opinion of the investigator. Time of onset is from date of randomization to date of first CDI recurrence. Time to first CDI recurrence was assessed using Kaplan-Meier curve. Due to small number of subjects (<50%) with CDI recurrence, median time to event was not evaluable.|Baseline (Day 1) up to Week 6|ITT-S population||days||Full Range|Median
832903|NCT01259726|Secondary|Number of Participants With Clinical Events of Diarrhea or Loose/Watery Stools|Data were derived from all AEs starting on or after Day 1 for which a Diarrhea CRF page was completed.|Baseline (Day 1) up to Week 6|ITT-S population.||Participants|||Number
832904|NCT01259726|Secondary|Number of Participants With Use of Antibacterial Treatment for CDI|Any antibacterial medication used after Day 1 for which the investigator selected the indication “antibacterial for C. difficile infection”.|Baseline (Day 1) up to Week 6|ITT-S population.||Participants|||Number
832931|NCT01260272|Secondary|Change in Diastolic Blood Pressure|Raisin versus snacks: change in diastolic blood pressure from baseline to week 12|12 weeks|Total # for analysis may not equal the randomized #. A last observation carried forward approach was utilized for those who did not complete the study, and who had at least 1 post treatment value. Subjects without at least 1 post treatment values were not included in the analysis. The analysis # was also adjusted by excluding defined outliers.||mmHg||Standard Error|Mean
832905|NCT01259726|Secondary|Number of Participants With Clostridium Difficile Infection (CDI) Recurrence|CDI recurrence was defined as at least 1 event characterized by ALL of the following: >=3 unformed (loose or watery) stools within 24 hours (data derived from Diarrhea case report form (CRF) page which was to be completed for any clinical event of diarrhea or loose/watery stool occurring between Day 1 and Week 6); a positive C. difficile stool assay, or pseudomembranes on endoscopy/surgery; and no other likely cause of the diarrhea in the opinion of the investigator.|Baseline (Day 1) up to Week 6|ITT-S population.||Participants|||Number
832906|NCT01259726|Primary|Number of Participants With Positive Clostridium Difficile Stool Cultures Demonstrating Non-Toxigenic Clostridium Difficile-Strain M3||After study drug administration period (14 days) through Week 6|ITT-S population.||Participants|||Number
832907|NCT01259726|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|An adverse event (AE) is any untoward, undesired, unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiological observations occurring in a study participant, regardless of causal relationship. TEAEs were defined as all AEs that start during the study drug treatment period (and up to 7 days after the last dose of the study drug) and were not seen at baseline, or were seen at baseline but increased in frequency and/or severity during the study drug treatment period (and up to 7 days after the last dose of study drug). SAE was any AE that results in any of the following outcomes: death, a life-threatening event, inpatient hospitalization or prolongation of an existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, a congenital anomaly/birth defect, other medically important events based upon appropriate medical judgement.|Baseline up to 7 days after the last dose of study drug (up to Week 3)|Intent-to-Treat-Safety (ITT-S) population was defined as all randomized participants who received at least 1 dose of study drug.||Participants|||Number
832908|NCT01260142|Secondary|Relative Bioavailability of Fospropofol and Propofol|The PK parameters for propofol from propofol injectable emulsion were used as the reference formulation. Because propofol is a metabolite of fospropofol, all calculations were conducted after correcting for the different molecular weights of these formulations. Molecular weights of 332.24 (288.24 for free base) and 178.27 were used for fospropofol disodium and propofol injectable emulsion, respectively. The propofol parameters were adjusted as appropriate as discussed above and natural log transformed prior to comparison. Relative bioavailability of propofol from fospropofol disodium (E2083) to propofol from propofol injectable emulsion is calculated as (AUC(FP) x Total Dose of Propofol/AUC(P) x Total Dose of E2083) x Molecular fraction, where AUC(FP) is AUC(0-t) or AUC(0-inf) of propofol from E2083, AUC(P) is AUC(0-t) or AUC(0-inf) of propofol from propofol injectable emulsion and molecular fraction is molecular weight of propofol (178.27)/E2083 (332.24).|Days 1, and 7-14 (Arterial Sample: Pre-dose, and 0.5, 1, 1.5, 2, 4, 8, 16, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose. Venous Sample: Pre-dose, and 1, 4, and 30 minutes post-dose).|PK Analysis Set||ng x hr/mL||Standard Deviation|Mean
832909|NCT01260142|Secondary|Maximal Sedative Effect Using the Modified Observer's Assessment of Alertness/Sedation Scale|PD effects were determined from continuous BIS score recordings and from clinical assessment of sedation using the MOAA/S scale. The MOAA/S scale was used to rate the level of alertness/sedation from a score of 0 (does not respond to painful stimulus) to 5 (alert) in the category of responsiveness, with 5 being the MOAA/S value for a fully awake adult. Time to sedation was defined as the time from the first dose of study medication to the first two consecutive MOAA/S scores less than or equal to 4. Fully awake status was reached at the first of 3 consecutive MOAA/S scores of 5 measured every 2 minutes after study drug administration. The MOAA/S scale was described by the Emax model.|Days 1, and 7-14 (2 minutes prior to study drug administration and every 2 minutes thereafter for 20 minutes or until the subject reached Fully Alert status, whichever was later).|PD Analysis Set||Scores on a scale||Standard Deviation|Mean
832910|NCT01260142|Secondary|Maximal Sedative Effect Using the Bispectral Index (BIS) Score|Pharmacodynamic (PD) effects were obtained from continuous BIS score recordings obtained throughout the study and from clinical assessment of sedation using the Modified Observer’s Assessment of Alertness/Sedation (MOAA/S) scale. The BIS measurements continued until the participant was fully recovered in the opinion of the investigator or until the PD effect measure returned to baseline. The BIS score varied between 100 (associated with being fully awake) and 0 (associated with a flat line on the electroencephalogram (EEG)). The BIS Index was described by the maximal effect (Emax) model.|Days 1, and 7-14 (BIS measurements were to continue until the subject was fully recovered in the opinion of the investigator or until the PD effect measures returned to baseline measures)|PD analysis set included all participants who had sufficient PD data to derive at least one PD assessment.||Scores on a scale||Standard Deviation|Mean
832911|NCT01260142|Primary|Maximum Drug Plasma Concentration of Propofol|Arterial and venous blood samples were collected and analyzed for propofol concentrations as described previously. Cmax was the highest plasma drug concentration observed over the entire sampling period, and was obtained directly from the experimental plasma concentration time data without interpolation. The plasma concentrations from the venous sampling were descriptively compared head-to-head with the arterial sampling.|Days 1, and 7-14 (Arterial Sample: Pre-dose, and 0.5, 1, 1.5, 2, 4, 8, 16, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose. Venous Sample: Pre-dose, and 1, 4, and 30 minutes post-dose).|PK Analysis Set||ug/mL||Standard Deviation|Mean
832912|NCT01260142|Primary|Maximum Drug Plasma Concentration (Cmax) of Fospropofol|Arterial and venous blood samples were collected and analyzed for fospropofol concentrations as described previously. Cmax was the highest plasma drug concentration observed over the entire sampling period, and was obtained directly from the experimental plasma concentration time data without interpolation. The plasma concentrations from the venous sampling were descriptively compared head-to-head with the arterial sampling.|Days 1, and 7-14 (Arterial Sample: Pre-dose, and 0.5, 1, 1.5, 2, 4, 8, 16, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose. Venous Sample: Pre-dose, and 1, 4, and 30 minutes post-dose).|PK Analysis Set||ug/mL||Standard Deviation|Mean
832932|NCT01260272|Secondary|Change in Systolic Blood Pressure|Raisin versus snacks: change in systolic blood pressure from baseline to week 12|12 weeks|Total # for analysis may not equal the randomized #. A last observation carried forward approach was utilized for those who did not complete the study, and who had at least 1 post treatment value. Subjects without at least 1 post treatment values were not included in the analysis. The analysis # was also adjusted by excluding defined outliers.||mmHg||Standard Error|Mean
832913|NCT01260142|Primary|Area Under the Plasma Concentration-Time Curve From Time 0 to Time t of Propofol|Arterial and venous blood samples were collected and analyzed for propofol concentrations as described previously. AUC(0-t) was calculated using the log-linear trapezoidal rule (linear trapezoidal rule up to Cmax, log trapezoidal rule following Cmax) from time of dosing to the last quantifiable concentration. The plasma concentrations from the venous sampling were descriptively compared head-to-head with the arterial sampling. In addition, the arterial plasma concentrations of fospropofol, propofol liberated from fospropofol, and propofol delivered from propofol injectable emulsion were used to refine the population PK model developed previously.|Days 1, and 7-14 (Arterial Sample: Pre-dose, and 0.5, 1, 1.5, 2, 4, 8, 16, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose. Venous Sample: Pre-dose, and 1, 4, and 30 minutes post-dose).|PK Analysis Set||ug.h/L||Standard Deviation|Mean
832914|NCT01260142|Primary|Area Under the Plasma Concentration-Time Curve From Time 0 to Time t (AUC(0-t)) of Fospropofol|Arterial and venous blood samples were collected and analyzed for fospropofol concentrations as described previously. AUC(0-t) was calculated using the log-linear trapezoidal rule (linear trapezoidal rule up to maximum observed plasma concentration (Cmax), log trapezoidal rule following Cmax) from time of dosing to the last quantifiable concentration. The plasma concentrations from the venous sampling were descriptively compared head-to-head with the arterial sampling.|Days 1, and 7-14 (Arterial Sample: Pre-dose, and 0.5, 1, 1.5, 2, 4, 8, 16, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose. Venous Sample: Pre-dose, and 1, 4, and 30 minutes post-dose).|PK Analysis Set||ug.h/L||Standard Deviation|Mean
832915|NCT01260142|Primary|Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of Propofol|An A-line and V-line were placed prior to dosing during each treatment period and used to collect blood samples for plasma concentration measurements at specific time points. Plasma arterial and venous concentrations of propofol were quantified by high-performance liquid chromatography with mass spectrometric detection (LC-MS/MS). The AUC(0-inf) was calculated from the sum of AUC(0-t) and the residual area calculated as Ct/λz, where Ct was the observed concentration at last quantifiable concentration and λz was the terminal elimination rate constant. The plasma concentrations from the venous sampling were descriptively compared head-to-head with the arterial sampling. In addition, the arterial plasma concentrations of fospropofol, propofol liberated from fospropofol, and propofol delivered from propofol injectable emulsion were used to refine the population PK model developed previously.|Days 1, and 7-14 (Arterial Sample: Pre-dose, and 0.5, 1, 1.5, 2, 4, 8, 16, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose. Venous Sample: Pre-dose, and 1, 4, and 30 minutes post-dose).|PK Analysis Set||ug.h/L||Standard Deviation|Mean
832916|NCT01260142|Primary|Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of Fospropofol (AUC(0-inf))|AUC(0-inf) is a measure of drug concentration equal to the area under the plasma concentration-time profile from time 0 to infinity. An arterial line (A-line) and venous line (V-line) were placed prior to dosing during each treatment period and used to collect blood samples for plasma concentration measurements at specific time points. Plasma arterial and venous concentrations of fospropofol were quantified by high-performance liquid chromatography with mass spectrometric detection (LC-MS/MS). The AUC(0-inf) was calculated from the sum of AUC from time 0 to time t (AUC(0-t)) and the residual area calculated as Ct/λz, where Ct was the observed concentration at last quantifiable concentration and λz was the terminal elimination rate constant. The plasma concentrations from the venous sampling were descriptively compared head-to-head with the arterial sampling.|Days 1, and 7-14 (Arterial Sample: Pre-dose, and 0.5, 1, 1.5, 2, 4, 8, 16, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose. Venous Sample: Pre-dose, and 1, 4, and 30 minutes post-dose).|Pharmacokinetic (PK) Analysis Set is the group of participants who have sufficient pharmacokinetic data to derive at least one PK parameter.||ug.h/L||Standard Deviation|Mean
832917|NCT01260194|Secondary|Number of Participants With Human Epidermal Growth Factor Receptor 2 (HER2) Positive Gastric Cancer|The HER2 status was determination by using immunohistochemistry (IHC) and confirmatory Fluorescent In Situ Hybridization (FISH) techniques. Only participants with HER2 positivity were allowed to receive study medication.|Baseline|Safety population.||participants|||Number
832918|NCT01260194|Secondary|Number of Participants With Clinically Significant Change From Baseline in Left Ventricular Ejection Fraction (LVEF)|The LVEF was measured using Multi Gated Acquisition (MUGA) or echocardiography (echocardiography was preferred), using the same technique throughout for consistency in an individual participant. Baseline LVEF assessments were done within 21 days prior to the start of treatment. Participants with clinically significant change from baseline (that is, absolute drop in LVEF of >=15%, and drop to a value <50%) have been reported.|Baseline, thereafter every 12 weeks (maximum up to 22 months)|Safety population.||participants|||Number
832919|NCT01260194|Secondary|Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters|Lab parameters assessed during the study were serum chemistry, biochemistry - serum electrolytes, hematology, 12 lead electrocardiogram, and urinalysis – protein, glucose, blood and other lab tests. Laboratory tests were graded according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTC) version 3.|Baseline up to 6 month after last dose of study drug (maximum up to 22 months)|Safety population.||participants|||Number
832920|NCT01260194|Secondary|Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in participant hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both serious and non-serious AEs.|Baseline up to 6 month after last dose of study drug (maximum up to 22 months)|Safety population included all participants who had received at least 1 dose of study drug.||participants|||Number
832933|NCT01260272|Primary|Percent Change in Postprandial Glucose Levels|Raisins compared with snacks: percent change in postprandial glucose levels from baseline to week 12|12 weeks|Total # for analysis may not equal the randomized #. A last observation carried forward approach was utilized for those who did not complete the study, and who had at least 1 post treatment value. Subjects without at least 1 post treatment values were not included in the analysis. The analysis # was also adjusted by excluding defined outliers.||Percent change from baseline||Standard Error|Mean
833985|NCT01263496|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 16).|The change between the value of fasting plasma glucose collected at week 16 and fasting plasma glucose collected at baseline.|Baseline and Week 16.|Values are Summary Statistics.||mg/dL||Standard Deviation|Mean
832921|NCT01260194|Secondary|Duration of Response (DR)|DR was based on RECIST criteria v1.1 and was defined as time from date the CR or PR was first recorded to the date on which PD was first noted. CR: complete disappearance of all target lesions and non-target disease, with the exception of nodal disease; all nodes, both target and non-target, must decrease to normal (short axis <10 mm); no new lesions. PR: >=30% decrease under baseline of the sum of diameters of all target lesions; no unequivocal progression of non-target disease; no new lesions. PD: at least 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions and/or appearance of 1 or more new lesions. For the participants with no documented progression after CR or PR, the censored date (the date of “death,” the “last tumor measurement,” “last date in drug log,” or “last follow-up”) was taken into consideration. The median duration of response with 95% CI was estimated using Kaplan Meier method.|Baseline up to PD or death (maximum up to 22 months)|ITT population. The number of participants analyzed signifies the number of participants analyzed for this outcome measure.||days||95% Confidence Interval|Median
832922|NCT01260194|Secondary|Percentage of Participants With Clinical Benefit Response (CBR)|CBR was defined as any response among stable disease (SD) for 6 weeks or longer, CR, or PR as determined by the RECIST v 1.1. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease; all nodes, both target and non-target, must decrease to normal (short axis <10 mm); no new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions (the short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions); no unequivocal progression of non-target disease; no new lesions. PD was defined as at least 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. SD was defined as not qualifying for CR, PR, or PD.|Baseline up to PD or death (maximum up to 22 months)|ITT population.||percentage of participants||95% Confidence Interval|Number
832923|NCT01260194|Secondary|Percentage of Participants With Overall Tumor Response|Overall tumor response was defined as the occurrence of either a confirmed complete response (CR) or a partial response (PR) as best overall response as determined by the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version (v) 1.1 from confirmed radio-graphic evaluations of target and non-target lesions. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease; all nodes, both target and non-target, must decrease to normal (short axis less than [<]10 mm); no new lesions. PR was defined as greater than or equal to (>=) 30% decrease under baseline of the sum of diameters of all target lesions (the short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions); no unequivocal progression of non-target disease; no new lesions.|Baseline up to PD or death (maximum up to 22 months)|ITT population.||percentage of participants||95% Confidence Interval|Number
832924|NCT01260194|Secondary|Overall Survival (OS)|OS was defined as the time from the date of enrollment to the date of the death (from any cause). If no death was observed, censored observations were taken into account in the analysis. The censoring date was the last date of “last tumor measurement,” “last date in drug log,” or “last follow-up.” The median overall survival time with 95% CI was estimated using Kaplan Meier method.|Baseline up to death (maximum up to 22 months)|ITT population.||days||95% Confidence Interval|Median
832925|NCT01260194|Primary|Median Progression Free Survival (PFS)|The PFS was defined as the median time between the day of enrollment and the first documentation of progressive disease (PD) or date of death, whichever occurred first. PD was defined as at least 20 percent (%) increase (including an absolute increase of at least 5 millimeters [mm]) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. The censoring date was the last date of “last tumor measurement,” “last date of study drug treatment,” or “last follow-up.” The median PFS time with 95% confidence interval (CI) was estimated using Kaplan Meier method.|Baseline up to PD or death (maximum up to 22 months)|ITT population.||days||95% Confidence Interval|Median
832926|NCT01260272|Secondary|Change in High Density Lipoprotein Cholesterol Levels|Raisin versus snacks: percent change in high density lipoprotein cholesterol levels from baseline to week 12|12 weeks|Total # for analysis may not equal the randomized #. A last observation carried forward approach was utilized for those who did not complete the study, and who had at least 1 post treatment value. Subjects without at least 1 post treatment values were not included in the analysis. The analysis # was also adjusted by excluding defined outliers.||Percent change from baseline||Standard Error|Mean
832927|NCT01260272|Secondary|Change in Waist Circumference|Raisin versus snacks: change in waist circumference from baseline to week 12|12 weeks|Total # for analysis may not equal the randomized #. A last observation carried forward approach was utilized for those who did not complete the study, and who had at least 1 post treatment value. Subjects without at least 1 post treatment values were not included in the analysis. The analysis # was also adjusted by excluding defined outliers.||cm||Standard Error|Mean
832928|NCT01260272|Primary|Percent Change in Body Weight|Raisin versus snacks: percent change in body weight from baseline to week 12|12 weeks|Total # for analysis may not equal the randomized #. A last observation carried forward approach was utilized for those who did not complete the study, and who had at least 1 post treatment value. Subjects without at least 1 post treatment values were not included in the analysis. The analysis # was also adjusted by excluding defined outliers.||Percent change from baseline||Standard Error|Mean
832929|NCT01260272|Primary|Percent Change in Fasting Glucose Levels|Raisins versus snacks: percent change in fasting glucose levels from baseline to week 12|12 weeks|Total # for analysis may not equal the randomized #. A last observation carried forward approach was utilized for those who did not complete the study, and who had at least 1 post treatment value. Subjects without at least 1 post treatment values were not included in the analysis. The analysis # was also adjusted by excluding defined outliers.||Percent change from baseline||95% Confidence Interval|Median
832930|NCT01260272|Secondary|Change in Hemoglobin A1c|Raisin versus snacks: change in hemoglobin A1c from baseline to week 12|12 weeks|Total # for analysis may not equal the randomized #. A last observation carried forward approach was utilized for those who did not complete the study, and who had at least 1 post treatment value. Subjects without at least 1 post treatment values were not included in the analysis. The analysis # was also adjusted by excluding defined outliers.||Percent change from baseline||Standard Error|Mean
832934|NCT01260311|Other Pre-specified|Patient Perception of Bladder Condition (PPBC) at Week 4 and Week 8|PPBC: a self-administered, single-item, questionnaire that asks participants to describe their perception of their bladder-related problems. The PPBC assessment is rated on a 6-point scale: 1=no problems at all, 2=some very minor problems, 3=some minor problems, 4=moderate problems, 5=severe problems, 6=many severe problems. Improvement is defined as negative change from baseline.|Week 4 and Week 8|This efficacy outcome measure was removed in Protocol Amendment 1 and thus data was not collected.|||||
832935|NCT01260311|Other Pre-specified|Number of UUI Episodes Per 24 Hours at Week 4 and Week 8|UUI episodes were defined as those with USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Week 4 and Week 8|This efficacy outcome measure was removed in Protocol Amendment 1 and thus data was not collected.|||||
832936|NCT01260311|Other Pre-specified|Number of Urgency Episodes Per 24 Hours at Week 4 and Week 8|Urgency episodes were defined as micturitions with USS rating of greater than or equal to (>=) 3. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Week 4 and Week 8|This efficacy outcome measure was removed in Protocol Amendment 1 and thus data was not collected.|||||
832937|NCT01260311|Other Pre-specified|Number of Micturitions Per 24 Hours at Week 4 and Week 8|Micturitions include episodes of voluntary micturition and episodes of Urgency Urinary Incontinence (UUI). UUI episodes were defined as those micturitions with Urinary Sensation Scale (USS) rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine.|Week 4 and Week 8|This efficacy outcome measure was removed in Protocol Amendment 1 and thus data was not collected.|||||
832938|NCT01260311|Primary|Number of Participants With Adverse Events (AEs) by Seriousness, Severity and Relationship to Treatment|Counts of participants who had treatment-emergent AEs (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to fesoterodine fumarate (Toviaz) was assessed by the investigator. Participants with multiple occurrences of an AE within a category were counted once within the category. Seriousness of an AE was assessed under the criteria of serious adverse event (SAE). AE was assessed according to severity; mild (not causing any significant problem, dose adjustment not required), moderate (caused problem that does not interfere significantly with usual activities or the clinical status, dose adjustment needed due to AE) and severe (caused problem that interferes significantly with usual activities or the clinical status, study drug stopped due to AE).|Baseline up to 28 days after last dose|Safety population defined as all participants who received at least one dose of study medication.||participants|||Number
832939|NCT01260324|Primary|Incidence Rate Ratio Between NAION Risk Factors and Recurrence of Visual Symptoms of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)|Categorized by risk factors of age (years) and sex (male or female). Incidence rate ratio and the 95% confidence interval adjusted for all the other covariates in the table.|01-January-2003 up to 31-December-2007|Participant population with definite and possible NAION cases identified by medical record review. N=number of participants with recurrence of visual symptoms; (n)=number of participants for variable (age or sex) for NAION cases and estimated person-years [(n=NAION cases) / person-years].||incidence rate ratio||95% Confidence Interval|Number
832940|NCT01260324|Primary|Incidence Rate Ratio Between NAION Risk Factors and Resolution of Visual Symptoms of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)|Categorized by risk factors of age (years) and sex (male or female). Incidence rate ratio and the 95% confidence interval adjusted for all the other covariates in the table.|01-January-2003 up to 31-December-2007|Participant population with definite and possible NAION cases identified by medical record review. N=number of participants with resolution of visual symptoms (each set of variables); (n)=number of participants for variable (age or sex) for NAION cases and estimated person-years [(n=NAION cases) / person-years].||incidence rate ratio||95% Confidence Interval|Number
832941|NCT01260324|Primary|Number of Participants With NAION by Time Course of Visual Change Onset: Intermittent, Abrupt (Acute), or Chronic (Adjudicated by Medical Record Review)||01-January-2003 up to 31-December-2007|Participants from the NAION cases population adjudicated by medical record review.||participants|||Number
832942|NCT01260324|Primary|Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by PDE-5 Inhibitor Use|Person-years estimated by dividing the number of Controls by the derived sampling fraction (20,000 divided by total person-time at risk). PDE-5 inhibitor use categorized by frequency of use in the number of days specific preceding diagnosis for NAION Cases or preceding the index date for Controls: Recent use=any dispensing in the preceding 60 days; Any use=any PDE-5 inhibitors use; Chronic use=at least a total of 26 days supply or 5 dispensings in the preceding 183 days; Non-chronic use=any dispensing in the preceding 183 days that does not meet the criteria for chronic use; Never use=none.|01-January-2003 up to 31-December-2007|Combined NAION cases and Controls populations. N=number of participants according to frequency of PDE-5 inhibitor use for males 40 years or older; (n)=number of participants for NAION cases and Controls, respectively, per variable of frequency of use and estimated person-years [(n=NAION cases, Controls) / person-years].||incidence rate per 1000 person-years||95% Confidence Interval|Number
832943|NCT01260324|Primary|Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Comorbid Diagnoses|Person-years estimated by dividing the number of Controls participants by the derived sampling fraction (20,000 divided by the total person-time at risk). Comorbid diagnoses categorized according to the International Classification of Diseases ninth-edition (ICD-9) diagnoses. Categories include Occlusion and stenosis of precerebral arteries (Occlusion / Stenosis), Other disorders of bone and cartilage (Bone and Cartilage), Symptoms involving head and neck (Head and Neck), and Other ill defined and unknown causes of morbidity and mortality (Ill defined / Unknown causes).|01-January-2003 up to 31-December-2007|Combined population includes NAION cases and Controls population; (n)=number of participants for NAION cases and Controls, respectively, and estimated person-years [(n=NAION cases, Controls) / person-years].||incidence rate per 1000 person-years||95% Confidence Interval|Number
832976|NCT01260662|Secondary|Procedural Recall|After patients returned to baseline mental status they were asked whether they were able to recall any of the procedure. Question was answered in a yes or no format.|Immediately after the end of the procedure, a single time point within 30 minutes of procedures conclusion.|100 subjects were randomized to each group, 90 subjects in the propofol arm completed the study, 85 in the 1:1 propofol/ketamine arm, and 96 in the 4:1 propofol/ketamine arm||percentage report recall of procedure|||Number
832944|NCT01260324|Primary|Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Baseline Risk Factors|Person-years estimated by dividing number of Controls (20,000) by derived sampling fraction (total person-time at risk). Risk factors include diabetes, smoking, obesity, erectile dysfunction, hyperlipidemia, myocardial infarction, other coronary artery disease, congestive heart failure, hypertension, use of beta or calcium channel blockers, angiotensin-converting enzyme inhibitors, nitrates, anti-platelet agents, diuretics, and recent phosphodiesterase type 5 (PDE-5) inhibitors use. Recent use=any dispensing in the 60 days preceding date of diagnosis for NAION cases or index date for Controls.|01-January-2003 up to 31-December-2007|Combined population; (n)=number of participants for NAION cases and Controls, respectively, and estimated person-years [(n=NAION cases, Controls) / person-years]. Only the covariates selected by the step wise regression procedure were summarized.||incidence rate per 1000 person-years||95% Confidence Interval|Number
832945|NCT01260324|Primary|Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Region|Person-years estimated by dividing the number of Controls participants by the derived sampling fraction (20,000 divided by the total person-time at risk). Region of the United States categorized as Northeast, Midwest, South, and West.|01-January-2003 up to 31-December-2007|Combined population includes NAION cases and Controls population; (n)=number of participants for NAION cases and Controls, respectively, and estimated person-years [(n=NAION cases, Controls) / person-years].||incidence rate per 1000 person-years||95% Confidence Interval|Number
832946|NCT01260324|Primary|Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Calendar Year|Person-years estimated by dividing the number of Controls participants by the derived sampling fraction (20,000 divided by the total person-time at risk). Calendar years include years 2003 to 2007.|01-January-2003 up to 31-December-2007|Combined population includes NAION cases and Controls population; (n)=number of participants for NAION cases and Controls, respectively, and estimated person-years [(n=NAION cases, Controls) / person-years].||incidence rate per 1000 person-years||95% Confidence Interval|Number
832947|NCT01260324|Primary|Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Sex|Person-years estimated by dividing the number of Controls participants by the derived sampling fraction (20,000 divided by the total person-time at risk). Sex categorized as Female or Male.|01-January-2003 up to 31-December-2007|Combined population includes NAION cases and Controls population; (n)=number of participants for NAION cases and Controls, respectively, and estimated person-years [(n=NAION cases, Controls) / person-years].||incidence rate per 1000 person-years||95% Confidence Interval|Number
832948|NCT01260324|Primary|Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Age|Person-years estimated by dividing the number of Controls participants by the derived sampling fraction (20,000 divided by the total person-time at risk). Age categorized by years.|01-January-2003 up to 31-December-2007|Combined NAION cases and Controls populations; (n)=number of participants for NAION cases and Controls, respectively, per estimated person-years [(NAION cases n, Controls n) / person-years].||incidence rate per 1000 person-years||95% Confidence Interval|Number
832949|NCT01260350|Secondary|Percentage of Participants With Virologic Failure|"The percentage of participants with on-treatment virologic failure (viral breakthrough, rebound, or nonresponse) or following treatment (viral relapse) was summarized.
On-treatment virologic failure was defined as:
Viral breakthrough (confirmed HCV RNA ≥ LOD after having previously had HCV RNA < LOD while on treatment),
Viral rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, or
Nonresponse (HCV RNA persistently ≥ LOD through 6 weeks of treatment)
Viral relapse was defined as confirmed HCV RNA ≥ LOD during the posttreatment period having achieved HCV RNA < LOD at the last on-treatment visit."|Up to Posttreatment Week 24|Safety Analysis Set||percentage of participants|||Number
832950|NCT01260350|Secondary|Change From Baseline in HCV RNA at Week 12|Data are not presented for Groups 6, 10, and 21 which ended treatment after Week 8 or Week 6. Data are not presented for Groups 16, 17, 18, and 20 because participants with detectable HCV RNA discontinued due to protocol-specified stopping rules.|Baseline to Week 12|Participants in the Safety Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
832951|NCT01260350|Secondary|Change From Baseline in HCV RNA at Week 8|Data are not presented for Group 21 which ended treatment after Week 6.|Baseline to Week 8|Participants in the Safety Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
832952|NCT01260350|Secondary|Change From Baseline in HCV RNA at Week 6||Baseline to Week 6|Safety Analysis Set||log10 IU/mL||Standard Deviation|Mean
832953|NCT01260350|Secondary|Percentage of Participants With HCV RNA < LOD at Week 12|Data are not presented for Groups 6, 10, and 21 which ended treatment after Week 8 or Week 6.|Week 12|Participants in the Safety Analysis Set with available data were analyzed.||percentage of participants|||Number
832954|NCT01260350|Secondary|Percentage of Participants With HCV RNA < LOD at Week 8|Data are not presented for Group 21 which ended treatment after Week 6.|Week 8|Participants in the Safety Analysis Set with available data were analyzed.||percentage of participants|||Number
832955|NCT01260350|Secondary|Percentage of Participants With HCV RNA < LOD at Week 6||Week 6|Safety Analysis Set||percentage of participants|||Number
832956|NCT01260350|Secondary|Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12)|SVR12 was defined as HCV RNA < the limit of detection (LOD; < 15 IU/mL) 12 weeks after the last dose of study drug.|Posttreatment Week 12|Safety Analysis Set||percentage of participants|||Number
832957|NCT01260350|Primary|Percentage of Participants Who Experienced Adverse Events|Adverse events (AEs) occurring from baseline (Day 1 for all groups) to 30 days following the last dose of study drug were summarized across the participant population. A participant was counted once if they had a qualifying event.|Up to 12 weeks plus 30 days|Safety Analysis Set: participants were randomized and received at least one dose of study medication.||Percentage of participants|||Number
832958|NCT01260454|Secondary|Number of Participants Who Used of Narcotics Following a Treprostinil Infusion Site Change|We counted the number of participants who used any amount of narcotic during the 14 day diary period.|14 days|One subject did not meet the inclusion criteria and was excluded from the efficacy analysis.||participants|||Number
833986|NCT01263496|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 12).|The change between the value of fasting plasma glucose collected at week 12 and fasting plasma glucose collected at baseline.|Baseline and Week 12|Values are Summary Statistics.||mg/dL||Standard Deviation|Mean
832959|NCT01260454|Secondary|Number of Participants Who Experienced Greater Than 6 Pain Level Using the 10 Point Visual Analog Score|Qutenza has not previously been used in patients with normal, healthy skin. We will assess the reaction to capsaicin in these patients as compared to the patients with unhealthy skin (post-herpetic neuralgia) who were studied in the registration trials for Qutenza. Pain immediately following Qutenza application was measured on a 10 point visual analog score with the word 'none' above 0 and 'agonizing' above 10.|60 minute period of patch application and subsequent 3 days|||participants|||Number
832960|NCT01260454|Primary|Pain Score on a Visual Analogue Scale|"Patients will record the maximum intensity of pain (0-10) each day after placing an infusion site in a diary with which they are already comfortable. They will record the score each day for 14 days unless they have recorded 0 for two consecutive days.
The primary outcome measure will be the average of those 14 maximum intensity pain scores (the sum of the maximum for each day divided by the number of days, generally 14; range 0-10)."|14 days after a new infusion site|One subject did not meet the inclusion criteria and was excluded from the efficacy analysis.||Visual Analogue Scale||Standard Deviation|Mean
832961|NCT01260467|Secondary|Number of Participants With Adverse Events|This study will look at the number of participants who develop adverse events or side effects thought to be related to the memantine.|24 months|||participants|||Number
832962|NCT01260467|Primary|6 Month Progression-free Survival||24 months|not evaluated due to poor patient accrual|||||
832963|NCT01260467|Primary|Overall Survival||30 months|not evaluated due to poor patient accrual|||||
832964|NCT01260493|Primary|Satisfaction With Health and Social Care||1 year||||||
832965|NCT01260493|Primary|Dependence in Activities of Daily Living|Changes in number of person dependent in one or more daily activity from baseline to follow-up.|1 year|||participants|||Number
832966|NCT01260493|Primary|Health Care Consumption|Number of hospital days and admission will be analysed|1 year||||||
832967|NCT01260584|Secondary|Characterization of the Pharmacokinetics (PK) Cmax of the Active Metabolite of Prasugrel and the Active Metabolite of Clopidogrel in Smokers and Non-smokers||After dose on Day 10 of Active Treatment Periods 1 and 2|1 clopidogrel smoker was not evaluable for this measure.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
832968|NCT01260584|Secondary|Characterization of the Pharmacokinetics (PK) Area Under Curve (AUC)(0-Last) of the Active Metabolite of Prasugrel and the Active Metabolite of Clopidogrel in Smokers and Non-smokers|Blood samples for determination of plasma concentrations of the prasugrel active metabolite, clopidogrel active metabolite, and clopidogrel inactive metabolite will be collected following the administration of the 10th (last) maintenance dose of each of the 2 Active Treatment Periods at 0.5, 1, 2, 4, and 6 hours post-dose.|After dose on Day 10 of Active Treatment Periods 1 and 2|1 Clopidogrel smoker participant was not evaluable for this measure.||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
832969|NCT01260584|Secondary|Responder Rate by Treatment and Smoking Status Based on Platelet Reactivity Index (PRI) <= 50%|Numerous studies have established an association between high on-treatment platelet reactivity with clopidogrel and an increased risk for post-PCI ischemic events. In this study, the percentages of “responders” and “poor responders” following treatment with prasugrel and clopidogrel were compared. Poor responders were defined based on an Accumetrics VerifyNow PRU >235 and a VASP PRI >50%, as assessed 24 hours after the 9th maintenance dose.|Day 10 for Active Treatment Periods 1 and 2|1 prasugrel smoker participant was not evaluable for this measure.||% participants with PRI <=50%|||Number
832970|NCT01260584|Secondary|Responder Rate by Treatment and Smoking Status Based on P2Y12 Reaction Units (PRU) <= 235||Day 10 for Active Treatment Periods 1 and 2|1 prasugrel smoker participant was not evaluable for this measure.||% participants with PRU <=235|||Number
832971|NCT01260584|Secondary|Assessment of Vasodilator Stimulated Phosphoprotein (VASP) by Treatment and Smoking Status|Day 10 occurs in each treatment period at which time data collections are made. Numerous studies have established an association between high on-treatment platelet reactivity with clopidogrel and an increased risk for post-PCI ischemic events. In this study, the percentages of “responders” and “poor responders” following treatment with prasugrel and clopidogrel were compared. Poor responders were defined based on an Accumetrics VerifyNow PRU >235 and a VASP PRI >50%, as assessed 24 hours after the 9th maintenance dose.|Day 10 for Active Treatment Periods 1 and 2|1 prasugrel smoker was unevaluable for this measure.||% vasodilator stimulated phosphoprotein||Standard Error|Least Squares Mean
832972|NCT01260584|Secondary|Assessment of P2Y12 Reaction Units (PRU) by Treatment and Smoking Status|"Day 10 occurs in each treatment period at which time data collections are made. 12.1.4. Responders and Poor Responders
Numerous studies have established an association between high on-treatment platelet reactivity with clopidogrel and an increased risk for post-PCI ischemic events. In this study, the percentages of “responders” and “poor responders” following treatment with prasugrel and clopidogrel were compared. Poor responders were defined based on an Accumetrics VerifyNow PRU >235 and a VASP PRI >50%, as assessed 24 hours after the 9th maintenance dose."|Day 10 for Active Treatment Periods 1 and 2|1 prasugrel smoker was unevaluable for this measure.||P2Y12 reaction unit||Standard Error|Least Squares Mean
832973|NCT01260584|Primary|Inhibition of Platelet Aggregation (IPA) in Prasugrel-treated and Clopidogrel-treated Smokers and Non-smokers Following 9 Days of Maintenance Therapy.|IPA will be measured by the Accumetrics P2Y12 Assay Device. Response will be assessed in P2Y12 Reaction Units and as Platelet Reactivity Index (vasodilator-stimulated phosphoprotein assay).|Baseline to day 10 for Active Treatment Periods 1 and 2|1 prasugrel smoker was unevaluable for this measure.||percentage of device derived inhibition||Standard Error|Least Squares Mean
832974|NCT01260649|Secondary|Number of Participants With Cognitive Side Effects|will compare the incidence of participants with memory deficits between groups, as determined by incidents of clinician reported cognitive adverse events|3 months|||Participants|||Count of Participants
832975|NCT01260649|Primary|Change in Hamilton Depression Rating Scale - 28|"HAMD will be administered at every ECT treatment.The HAM D 28 is a 28 item scale with scores ranging from 0 to 83, with 0 being no depression and 83 being high levels of depression symptoms.
The change in HAM S score was determined by the difference of the HAM D score at the last ECT administration and the baseline HAM D score. A negative change score reflects a decreased HAM D score between the first and last ECT administration and therefore a reduction in depressive symptoms."|baseline, one month|||units on a scale||Standard Deviation|Mean
832977|NCT01260662|Secondary|Respiratory Depression|Continuous capnographic monitoring|From start of sedation procedure to end of sedation procedure, up to 24 hours|100 subjects were randomized to each group, 90 subjects in the propofol arm completed the study, 85 in the 1:1 propofol/ketamine arm, and 96 in the 4:1 propofol/ketamine arm||number of respiratory depression events|||Number
832978|NCT01260662|Primary|Hypoxia|Pulse oximetry|From start of sedation procedure to end of sedation procedure, up to 24 hours|100 subjects were randomized to each group, 90 subjects in the propofol arm completed the study, 85 in the 1:1 propofol/ketamine arm, and 96 in the 4:1 propofol/ketamine arm||Patients which experienced hypoxia|||Number
832979|NCT01260662|Primary|Clinical Interventions During Sedation|Add/increase in supplemental oxygen, stimulation to induce respiration, airway repositioning, assisted ventilations, endotracheal intubation|From start of sedation procedure to end of sedation procedure, up to 24 hours|100 subjects were randomized to each group, 90 subjects in the propofol arm completed the study, 85 in the 1:1 propofol/ketamine arm, and 96 in the 4:1 propofol/ketamine arm||Clinical interventions performed|||Number
832980|NCT01260688|Secondary|Symptom Assessment Using FACT-P Questionnaire and PPI Scale||Up to 12 weeks||||||
832981|NCT01260688|Secondary|Incidence of Toxicities Graded According to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) v4.0||Up to 30 days after last dose of study drugs||||||
832982|NCT01260688|Primary|12-week Progression-free Survival as Per the Prostate Cancer Clinical Trials Working Group (PCWG2)|Compared between the two arms using Z test.|3 months|Based on primary endpoint, 8 patients in Arm II had PFS equal than or greater than 12 weeks as opposed to Arm I where only 2 patients had PFS equal than or greater than 12 weeks.||participants|||Number
832983|NCT01260701|Secondary|Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug|Any CTCAE 4.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which were possibly, probably or definitely related to protocol treatment are included.|Up to 2 years|Eligible patients who received any treatment and were assessed for adverse events are included in this summary.||Participants|||Number
832984|NCT01260701|Secondary|Response Rate (Complete and Partial, Confirmed and Unconfirmed)|Complete response (CR) is complete disappearance of all target and non-target lesions, no new lesions, and no disease related symptoms. Any lymph nodes must have reduction in short axis to < 1.0 cm. Partial response (PR) is >= 30% decrease under baseline of the sum of appropriate diameters of all target measurable lesions, no unequivocal progression of non-measurable disease, and no new lesions. Confirmed CR is two or more statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration. Confirmed PR is two or more statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration, but not qualifying as CR. Unconfirmed CR is one status of CR documented before progression or symptomatic deterioration but not qualifying as CR or PR. Unconfirmed PR is one status of PR documented before progression or symptomatic deterioration but not qualifying as CR, PR or unconfirmed CR.|Up to 2 years|Eligible patients who began protocol therapy and were assessed for response.||percentage of participants||95% Confidence Interval|Number
832985|NCT01260701|Primary|Overall Survival (OS)|Overall survival is calculated from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Up to 2 years|Eligible patients who began protocol therapy.||months||95% Confidence Interval|Median
832986|NCT01260701|Secondary|Progression Free Survival (PFS)|PFS is measured from date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and without report of progression are censored at date of last contact. Progression is one or more of the following: 20% increase in the sum of appropriate diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy), as well as an absolute increase of at least 0.5 cm; unequivocal progression of non-measurable disease in the opinion of the treating physician; appearance of any new lesion/site; death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration is global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.|Up to 2 years|Eligible patients who began protocol therapy||months||95% Confidence Interval|Median
832987|NCT01260883|Secondary|Oximetry Saturation Under 90% After Ketorolac or Placebo Infusion in 6-18 Month Old Infants|continuous oximetry monitoring for 12 hours after ketorolac or placebo intravenous infusion in 6-18 month old infants after surgery|24 hours after surgery|52 infants aged 6-18 months enrolled; 15 excluded. 25 received ketorolac, 12 received placebo||per cent time of 12 hours||Standard Deviation|Mean
832988|NCT01260883|Secondary|Total Morphine Use in 6-18 Month Old Infants After Ketorolac or Placebo Intravenous Infusion After Surgery|total amount of morphine given for 12 hours after ketorolac or placebo infusion in 6-18 month old infants after surgery|24 hours after surgery|52 infants aged 6-18 months enrolled; 15 excluded. 25 received ketorolac and 12 received placebo infusion after surgery||mg/kg||Standard Deviation|Mean
832989|NCT01260883|Primary|Half-life of Ketorolac Stereo-isomers in 6-18 Month Old Infants After Surgery|noncompartmental pharmacokinetic analysis of ketorolac stereo-isomers after intravenous infusion in postoperative infants|24 hours after surgery|52 infants of the 77 total were aged 6-18 months. 15 were excluded for abnormal laboratory values at screening or for lack of access to draw blood samples. 25 received drug, 12 placebo.Doses 0.5 or 1 mg/kg reported together since no difference in analysis.||min||Standard Deviation|Mean
832990|NCT01260883|Primary|Ketorolac Stereo-isomer Volume of Distribution Peripheral in 6-18 Month Old Infants|population-based analysis of ketorolac stereo-isomers|24 hours after surgery|52 infants aged 6-18 months enrolled; 15 excluded. 25 received ketorolac, 12 received placebo. Drug handling not different at doses of 0.5 or 1 mg/kg so reported together.||ml||Standard Error|Mean
832991|NCT01260883|Primary|Volume of Distribution for Ketorolac Isomers in 6-18 Month Old Infants|population-based kinetic analysis of ketorolac isomers following intravenous infusion in infants after surgery|24 hours after surgery|of 52 enrolled infants aged 6-18 months, 37 completed the study. Of these, 25 received drug, 12 placebo.Doses of 0.5 or 1 mg/kg showed no difference in handling so reported together.||ml||Standard Error|Mean
833031|NCT01261325|Secondary|All Seizure Frequency (Type I + II + III) During the 12-week Treatment Period||12 week Treatment Period|Analysis population consists of the Intent-to-Treat (ITT) Population, which is all randomized subjects who received at least 1 dose of study medication and have at least 1 post-Baseline seizure diary.||number of seizures/ 28-day||Inter-Quartile Range|Median
832992|NCT01260883|Primary|Clearance of S- and R+ Ketorolac in 6-18 Month Old Infants|stereo-specific ketorolac clearance by population-based analysis (NONMEM)|24 hours after surgery|52 infants aged 6-18 months enrolled; 15 excluded for abnormal laboratory results or intravenous sampling catheters that did not allow sampling. 25 infants aged 6-18 months received ketorolac, 12 received placebo. Doses of 0.5 or 1 mg/kg reported together since no difference found in handling.||ml/min||Standard Error|Mean
832993|NCT01260883|Secondary|Percent Time With Room Air Oximetry Saturations Under 90% in 2-6 Month Infants|continuous oximetry monitoring of room air saturation was collected for 12 hours after intravenous infusion of ketorolac or placebo|12 hours after ketorolac or placebo infusion|25 infants aged 2-6 months enrolled; 11 excluded. 8 received ketorolac, 6 placebo||percentage of time in 12 h after drug||Full Range|Median
832994|NCT01260883|Secondary|Morphine Use in 2-6 Month Old Infants Given Ketorolac or Placebo Following Surgery|total morphine given intravenously in the 12 hours following receiving intravenous ketorolac or placebo|first day after surgery|25 infants enrolled but 11 excluded. 8 received ketorolac, 6 placebo. total morphine given over 12 hours following infusion collected||mg/kg||Standard Deviation|Mean
832995|NCT01260883|Primary|Half-life of S- and R+ Ketorolac in 2-6 Month Old Infants|half-life calculated from non-compartmental analysis of ketorolac isomers in 2-6 month old infants given intravenous ketorolac following surgery|24 hours after surgery|total infants enrolled was 77; 26 were excluded before study procedures began. Of 51 infants completing the study, 8 infants aged 2-6 months received drug.No difference in analysis at doses of 0.5 or 1 mg/kg so reported together.||min||Standard Error|Mean
832996|NCT01260883|Primary|Peripheral Volume of Distribution for S- and R+ Ketorolac in 2-6 Month Old Infants|peripheral volume of distribution for ketorolac stereo-isomers determined by population kinetic analysis (NONMEM)|24 hours post surgery|25 infants aged 2-6 months enrolled; 11 excluded for no sampling intravenous access. 8 infants received drug, 6 received placebo. No difference in analysis of doses of 0.5 or 1 mg/kg so reported together.||ml||Standard Deviation|Mean
832997|NCT01260883|Primary|Central Volume of Distribution for S- and R+ Ketorolac in 2-6 Month Old Infants|stereo-specific ketorolac analysis using population-based analysis (NONMEM)for ketorolac given intravenously 24 hours after surgery in 2-6 month old infants|24 hours after surgery|infants enrolled but did not complete protocol if abnormal laboratory studies or intravenous catheters were not functioning prior to study drug infusion. Of 77 enrolled, 51 completed study; of the 33 given ketorolac,8 were aged 2-6 months. Doses of 0.5 or 1 mg/kg were handled similarly so reported together.||ml||Standard Error|Mean
832998|NCT01260883|Primary|Clearance of S-ketorolac and R+ Ketorolac in 2-6 Month Old Infants Following Surgery|stereo-isomer specific clearance determined by population-based pharmacokinetic analysis (NONMEM)|24 hours following surgery|of 25 infants aged 2-6 months enrolled, 11 were excluded. 8 received drug, 6 received placebo; this is a subset of the 77 enrolled infants (aged 2-18 months) of whom 51 completed the study. Infants receiving drug at 0.5 or 1 mg/kg were reported together, since no difference in drug handling was seen.||ml/min||Standard Error|Mean
832999|NCT01260896|Secondary|AUC0-inf of O-Desmethylvenlafaxine.|Informational comparison of AUC0-inf values for the metabolite O-Desmethylvenlafaxine.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
833000|NCT01260896|Secondary|AUC0-t of O-Desmethylvenlafaxine.|Informational comparison of AUC0-t values for the metabolite O-Desmethylvenlafaxine.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
833001|NCT01260896|Secondary|Cmax of O-Desmethylvenlafaxine.|Informational comparison of Cmax values for the metabolite O-Desmethylvenlafaxine.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
833002|NCT01260896|Primary|AUC0-inf of Venlafaxine.|Bioequivalence based on Venlafaxine AUC0-inf (area under the concentration-time curve from time zero to infinity).|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
833003|NCT01260896|Primary|AUC0-t of Venlafaxine.|Bioequivalence based on Venlafaxine AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
833004|NCT01260896|Primary|Cmax of Venlafaxine.|Bioequivalence based on Venlafaxine Cmax (maximum observed concentration of drug substance in plasma).|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
833005|NCT01260922|Primary|AUC0-t of Donepezil.|Bioequivalence based on Donepezil AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
833006|NCT01260922|Primary|Cmax of Donepezil.|Bioequivalence based on Donepezil Cmax (maximum observed concentration of drug substance in plasma).|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
833007|NCT01260948|Primary|AUC0-t of Donepezil.|Bioequivalence based on Donepezil AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
833008|NCT01260948|Primary|Cmax of Donepezil.|Bioequivalence based on Donepezil Cmax (maximum observed concentration of drug substance in plasma).|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
833009|NCT01261000|Primary|Effect of Pegvisomant on Colon Tissue p53 Expression|Induction of colon tissue expression of p53, a tumor suppressor, using Western blot analysis, after GH receptor blockade with pegvisomant|8 weeks|||ng/mL||Standard Deviation|Mean
833010|NCT01261052|Secondary|Measurement of APD and FMPD/APD Interventions in Controlling Post-prandial Blood Glucose With Reduced Insulin Sensitivity.|Assessment of control of post prandial hyperglycemia with APD and FMPD/APD interventions using mean post-prandial glucose (3 hours after meals).|all 33 hour studies|The number of participants for analysis was determined by an intention to treat (ITT) analysis based on the initial treatment assignment||mg/dl||Standard Deviation|Mean
833011|NCT01261052|Primary|Measurement of the Effectiveness of APD and FMPD/APD Intervention in Adapting to Reduced Insulin Sensitivity|The effectiveness of the APD and FMPD/APD intervention in adapting to reduced insulin sensitivity was analyzed using mean glucose.|all 33 hour studies|The number of participants for analysis was determined by an intention to treat (ITT) analysis based on the initial treatment assignment||mg/dl||Standard Deviation|Mean
833012|NCT01253980|Primary|Treatment Failure|A treatment failure was a patient who at any time deteriorated necessitating a change to the treatment regimen. This was determined by assessing reported symptoms (cough, shortness of breath, wheeze and fever) and comparing clinical signs (respiratory rate, oxygen saturation, wheeze, flaring, grunting, recessions, crepitations, temperature, mental status) to signs at presentation.|At routine follow-up 3 and 5 days post-ingestion or earlier if necessary|per protocol||participants||95% Confidence Interval|Number
833013|NCT01254045|Secondary|Salivary Cortisol|salivary cortisol level measured immediately before social challenge task and 20 minutes following social challenge task at each time point (i.e., baseline, week 2, and week 3)|baseline, week 2, and week 3|||nmol/L||Standard Error|Mean
833014|NCT01254045|Primary|Eye Contact/Gaze During 10 Minute Social Challenge Task|Number of times that eye gaze occurred (i.e., participant looked at female experimenter in the eyes) during 10 minute social challenge task (first 5 minutes social proximity, second 5 minutes social interaction). The social challenge task occurred 50 minutes after internasal dose (of placebo, placebo + oxytocin, or oxytocin) at baseline, week 2, and week 3 visits.|baseline, week 2, and week 3|||eye contact/gaze events per 10 minutes||Standard Error|Mean
833015|NCT01254188|Secondary|Kaplan-Meier Estimates of Failure-free Survival|Time to event (months) = (date of event or censoring – date of study entry + 1) / 30.4375. Date of event is the earliest date of the following events during treatment : discontinuation of nilotinib for nilotinib-related adverse events, death due to any cause, progression to AP or BC, loss of PCyR, loss of CCyR, loss of CHR. Time is censored at the date of last assessment in the trial for patients without event.|3,6,9,12,15,18,21,and 24 months|FAS||percentage probability||95% Confidence Interval|Number
833016|NCT01254188|Secondary|Kaplan-Meier Estimates of Progression-free Survival|PFS was defined as the time from the date of study entry to the date of event defined as the first documented disease progression to AP/BC or the date of death from any cause occurring on treatment.|3,6,9,12,15,18,21,and 24 months|FAS||percentage probability||95% Confidence Interval|Number
833017|NCT01254188|Secondary|Overall Survival|OS was defined as the time between date of study entry and date of death due to any cause at any time during the study, including the follow-up period after discontinuation of treatment.|3, 6, 9, 12, 15, 18, 21, 24 Months|||percentage probability||95% Confidence Interval|Number
833018|NCT01254188|Secondary|Percentage of Participants Estimated to Maintain Their First CCyR for 6, 12, 18, and 24 Months After the First CCyR Was Achieved as Determined by Kaplan Meier Estimatation.|"* CCyR = 0% Ph+ metaphases based on at least 20 metaphases from bone marrow cytogenetics.
Duration of first CCyR (months) = (date of CCyR loss or censoring – date of first CCyR +1) / 30.4375"|6,12,18 and 24 months|||percentage of participants||95% Confidence Interval|Number
833019|NCT01254188|Secondary|Complete Cytogenetic Response|Complete cytogenetic response (CCyR) is defined as a value of 0% Ph+ metaphases in bone marrow.|6 months|||percentage of participants||95% Confidence Interval|Number
833020|NCT01254188|Secondary|Duration of Major Molecular Response|Kaplan-Meier estimates of duration of first MMR among patients who achieved MMR (FAS) Duration of first MMR (months) = (Minimum date of (loss of first MMR , CML-related death, progression to AP/BC during study treatment, censoring) – date of first MMR + 1) / 30.4375|3, 6, 9, 12, 15, 18, 21, 24 Months after MMR was detected|Full Analysis set, Number of events / censored 29/312.||percentage of participants||95% Confidence Interval|Number
833021|NCT01254188|Secondary|Time to Molecular Response at 24 Months|Estimated median time to first MMR by Kaplan-Meier method|24 months|Full analysis set||Months||95% Confidence Interval|Median
833022|NCT01254188|Primary|The Percentage of Patients Achieving MMR by 12 Months|MMR is defined as BCR-ABL ratio (%) on IS <= 0.1% (corresponds to >=3 log reduction of BCR-ABL transcripts from standardized baseline value). Clopper-Pearson method|12 months|||percentage of participants||95% Confidence Interval|Number
833023|NCT01254214|Secondary|Center for Epidemiologic Studies Depression Scale (CESD)|The CES-D is a 20-item self-report scale to measure symptoms of depression in the past week with scores having a range of 0 to 60 and a score of 16 or higher indicating clinically relevant symptoms.|baseline, 8 weeks, 26 weeks|||units on a scale||Standard Deviation|Mean
833024|NCT01254214|Secondary|Pittsburgh Sleep Quality Index (PSQI)|The PSQI is a 19-item self-reported sleep quality measure with scores that range from 0 to 21, where higher scores indicate worse sleep quality. Scores greater than 5 indicate poor sleep.|baseline, 8 weeks, 26 weeks|||units on a scale||Standard Deviation|Mean
833025|NCT01254214|Secondary|SF-12 PCS|Physical component summary score (PCS) of the SF-12 is a self-reported measure of physical health-related quality of life.Scores are reported as standardized T-scores, where an average (mean) score in the general population is 50 with a standard deviation of 10. Scores of 40 or less indicate impaired physical health quality or function.|baseline, 8 weeks, 26 weeks|||T scores||Standard Deviation|Mean
833026|NCT01254214|Secondary|Short Form -12 MCS|Mental component summary score (MCS) of the SF-12 is a self-reported measure of mental health-related quality of life. Scores are reported as standardized T-scores, where an average (mean) score in the general population is 50 with a standard deviation of 10. Scores of 40 or less indicate impaired mental health quality or function.|baseline, 8 and 26 weeks|||T-Scores||Standard Deviation|Mean
833027|NCT01254214|Primary|State-Trait Anxiety Inventory|The STAI is a 20 item scale that measures current anxiety symptoms with scores that range from 20 to 80, with higher scores indicating greater levels of anxiety. The norm for working adults is a score of 34.|Baseline, 8 weeks, 26 weeks|||units on a scale||Standard Deviation|Mean
833028|NCT01261325|Secondary|Time to the Tenth Type I Seizure During the Treatment Period||12 week Treatment Period|||days||95% Confidence Interval|Median
833029|NCT01261325|Secondary|Time to the Fifth Type I Seizure During the Treatment Period||12 week Treatment Period|||days||95% Confidence Interval|Median
833030|NCT01261325|Secondary|Time to the First Type I Seizure During the Treatment Period||12 week Treatment Period|Analysis population consists of the Intent-to-Treat (ITT) Population, which is all randomized subjects who received at least 1 dose of study medication and have at least 1 post-Baseline seizure diary.||days||95% Confidence Interval|Median
833032|NCT01261325|Secondary|Seizure Freedom Rate (All Seizure Types) During the 12-week Treatment Period||12 week Treatment Period|Analysis population consists of the Intent-to-Treat (ITT) Population, which is all randomized subjects who received at least 1 dose of study medication and have at least 1 post-Baseline seizure diary.||percentage of subjects|||Number
833033|NCT01261325|Secondary|Categorized Percent Reduction Form Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the Treatment Period||Baseline to 12 week Treatment Period|Analysis population consists of the Intent-to-Treat (ITT) Population, which is all randomized subjects who received at least 1 dose of study medication and have at least 1 post-Baseline seizure diary.||percentage of subjects|||Number
833034|NCT01261325|Secondary|Percent Change in Partial Onset Seizure (Type I) Frequency From the Baseline to the Treatment Period||Baseline to 12 week Treatment Period|Analysis population consists of the Intent-to-Treat (ITT) Population, which is all randomized subjects who received at least 1 dose of study medication and have at least 1 post-Baseline seizure diary.||percentage of change||Inter-Quartile Range|Median
833035|NCT01261325|Primary|50% Responder Rate for Partial Onset Seizure (Type I) Frequency Over the Treatment Period Standardized to a 28-day Duration|Primary Endpoint: European Regulatory Authorities A responder is a participant who experienced a 50% or greater reduction in partial onset seizure (Type I) frequency over the Treatment Period standardized to a 28-day duration.|Baseline to 12 week Treatment Period|Analysis population consists of the Intent-to-Treat (ITT) Population, which is all randomized subjects who received at least 1 dose of study medication and have at least 1 post-Baseline seizure diary.||Percentage of subjects|||Number
833036|NCT01261325|Primary|Percent Reduction Over Placebo for Partial Onset Seizure (Type I) Frequency Over the Treatment Period Standardized to a 28-day Duration|Primary endpoint: United States of America (FDA)|12 week Treatment Period|Analysis population consists of the Intent-to-Treat (ITT) Population, which is all randomized subjects who received at least 1 dose of study medication and have at least 1 post-Baseline seizure diary.||Percentage of reduction|||Number
833037|NCT01261390|Secondary|Peak Tricuspid Regurgitation Velocity (4 Arm) - 12 Month|12 Month Peak Tricuspid Regurgitation Velocity measured via echocardiography.|12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).||cm/sec||Standard Deviation|Mean
833038|NCT01261390|Secondary|E/Em Lateral Ratio (4 Arm) - 12 Month|Endpoint E/Em Lateral Ratio measured via echocardiography.|12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).||mitral velocity ratio (absolute units)||Standard Deviation|Mean
833039|NCT01261390|Secondary|Pulmonary Vascular Resistance (4 Arm) - 12 Month|Endpoint Pulmonary Vascular Resistance measured via echocardiography.|12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).||Wood units||Standard Deviation|Mean
833040|NCT01261390|Secondary|Tricuspid Annular Peak Systolic Myocardial Velocity (4 Arm) - 12 Month|Endpoint Tricuspid Annular Peak Systolic Myocardial Velocity measured via echocardiography.|12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).||cm/sec||Standard Deviation|Mean
833041|NCT01261390|Secondary|Right Ventricular Fractional Area Change (4 Arm) - 12 Month|Endpoint Right Ventricular Fractional Area Change measured via echocardiography.|12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).||percentage change in RV area||Standard Deviation|Mean
833042|NCT01261390|Secondary|Ejection Fraction (4 Arm) - 12 Month|Endpoint Ejection Fraction measured via echocardiography.|12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).||percentage ejection fraction||Standard Deviation|Mean
833043|NCT01261390|Secondary|End-Diastolic Volume (4 Arm) - 12 Month|Endpoint End-Diastolic Volume measured via echocardiography.|12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).||cm||Standard Deviation|Mean
833044|NCT01261390|Secondary|Left Atrial Volume Index (4 Arm) - 12 Month|Endpoint Left Atrial Volume Index measured via echocardiography.|12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).||m/m2||Standard Deviation|Mean
833045|NCT01261390|Secondary|Left Ventricular Mass Index (4 Arm) - 12 Month|Endpoint Left Ventricular Mass Index measured via echocardiography.|12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).||g/m2||Standard Deviation|Mean
833143|NCT01265459|Secondary|Subject´s Global Assessment of the Status of the Study Knee (Change From Baseline)|"The subject will assess his/her global status how the study knee affects them by using a 11-point numerical rating scale, Subject global assessment scale, from very poor=0 to excellent=10."|26 weeks after treatment compared to baseline|||units on a scale||Standard Deviation|Mean
833046|NCT01261390|Secondary|Peak Tricuspid Regurgitation Velocity (4 Arm) - Baseline|Baseline Peak Tricuspid Regurgitation Velocity measured via echocardiography.|12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).||cm/sec||Standard Deviation|Mean
833047|NCT01261390|Secondary|E/Em Lateral Ratio (4 Arm) - Baseline|Baseline E/Em Lateral Ratio measured via echocardiography.|12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).||mitral velocity ratio (absolute units)||Standard Deviation|Mean
833048|NCT01261390|Secondary|Pulmonary Vascular Resistance (4 Arm) - Baseline|Baseline Pulmonary Vascular Resistance measured via echocardiography.|12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).||Wood units||Standard Deviation|Mean
833049|NCT01261390|Secondary|Tricuspid Annular Peak Systolic Myocardial Velocity (4 Arm) - Baseline|Baseline Tricuspid Annular Peak Systolic Myocardial Velocity measured via echocardiography.|12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).||cm/sec||Standard Deviation|Mean
833050|NCT01261390|Secondary|Right Ventricular Fractional Area Change (4 Arm) - Baseline|Baseline RV Fractional Area Change measured via echocardiography.|12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).||percentage change in RV area||Standard Deviation|Mean
833051|NCT01261390|Secondary|Ejection Fraction (4 Arm) - Baseline|Baseline Ejection Fraction measured via echocardiography.|12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).||percent ejection fraction||Standard Deviation|Mean
833052|NCT01261390|Secondary|End-Diastolic Volume (4 Arm) - Baseline|Baseline End-Diastolic Volume measured via echocardiography.|12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).||cm||Standard Deviation|Mean
833053|NCT01261390|Secondary|Left Atrial (LA) Volume Index (4 Arm) - Baseline|Baseline Left Atrial Mass Index measured via echocardiography.|12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).||m/m2||Standard Deviation|Mean
833054|NCT01261390|Secondary|Left Ventricular (LV) Mass Index (4 Arm) - Baseline|Baseline Left Ventricular Mass Index measured via echocardiography.|12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).||g/m2||Standard Deviation|Mean
833055|NCT01261390|Secondary|Change in Augmentation Index at Months 6 and 12 (4 Arms)|Tonometry measurements of arterial stiffness were collected using a Sphygmacor. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.|Mean of 6- and 12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Tonometry measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).||percent of central pulse pressure||Standard Deviation|Mean
833056|NCT01261390|Secondary|Change in Pulse Wave Velocity (PWV) at Months 6 and 12 (4 Arms)|Tonometry measurements of arterial stiffness were collected using a Sphygmacor. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.|Mean of 6- and 12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Tonometry measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).||m/s||Standard Deviation|Mean
833057|NCT01261390|Secondary|Change in Plasminogen Activator Inhibitor-1 (PAI-1) at Months 6 and 12 (4 Arm)|Plasminogen Activator Inhibitor-1 (PAI-1) was calculated from blood samples. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.|Mean of 6- and 12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).||AU/mL||Standard Deviation|Mean
833058|NCT01261390|Secondary|Change in Urinary Albumin Creatinine Ratio at Months 6 and 12 (4 Arm)|Urinary Albumin Creatinine Ratio was calculated from urine samples. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.|Mean of 6- and 12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).||ug/mg||Standard Deviation|Mean
833059|NCT01261390|Secondary|Change in Urine Microalbumin at Months 6 and 12 (4 Arm)|Urine Microalbumin was calculated from urine samples. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.|Mean of 6- and 12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).||ug/mL||Standard Deviation|Mean
833060|NCT01261390|Secondary|Change in Glomerular Filtration Rate (GFR) at Months 6 and 12 (4 Arm)|Glomerular Filtration Rate was calculated from blood samples collected through fasting phlebotomy. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.|Mean of 6- and 12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).||mL/min/1.73m^2||Standard Deviation|Mean
833061|NCT01261390|Secondary|Change in Interleukin 6 (IL-6) at Months 6 and 12 (4 Arm)|Interleukin 6 (IL-6) was calculated from blood samples collected through fasting phlebotomy. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.|Mean of 6- and 12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).||pg/dL||Standard Deviation|Mean
833062|NCT01261390|Secondary|Change From Baseline in Fasting Insulin at Months 6 and 12 (4 Arm)|Fasting Insulin was calculated from blood samples collected through fasting phlebotomy. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.|Mean of 6- and 12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).||uIU/mL||Standard Deviation|Mean
833063|NCT01261390|Secondary|Change From Baseline in Hemoglobin A1c Percentage at Months 6 and 12 (4 Arm)|Hemoglobin A1c percentage was calculated from blood samples collected through fasting phlebotomy. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.|Mean of 6- and 12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).||percentage glycosylated hemoglobin||Standard Deviation|Mean
833064|NCT01261390|Secondary|Change in Glucose, Fibrinogen, Creatinine and BNP at Months 6 and 12 (4 Arm)|Glucose, Fibrinogen, Creatinine and BNP measurements were calculated from blood and urine samples collected through fasting phlebotomy and urine collection. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.|Mean of 6- and 12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).||mg/dL||Standard Deviation|Mean
833065|NCT01261390|Secondary|Change in Lipid Panel at 6 and 12 Months (4 Arm)|Lipid panel measurements were calculated from blood samples collected through fasting phlebotomy. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.|Mean of 6- and 12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Lipid measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).||mg/dL||Standard Deviation|Mean
833066|NCT01261390|Secondary|Change in C-Reactive Protein at Months 6 and 12 (4 Arm)|C-Reactive Protein laboratory measurements were calculated from blood samples collected through fasting phlebotomy. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.|Mean of 6- and 12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).||mg/L||Standard Deviation|Mean
833067|NCT01261390|Secondary|Change in the Calgary Sleep Apnea Quality of Life Index (SAQLI) (4 Arm)|The Calgary Sleep Apnea Quality of Life Index (SAQLI) is a scale intended to measure disease-specific quality of life. The SAQLI score ranges from 1 - 7, with higher scores indicating a higher quality of life. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.|Mean of 6- and 12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).||units on a scale||Standard Deviation|Mean
833068|NCT01261390|Secondary|Change in Patient Health Questionnaire (PHQ8) (4 Arm)|The Patient Health Questionnaire (PHQ-8) is a scale intended to measure depression. The PHQ-8 score ranges from 0 24, with higher scores indicating increasing severity of depression. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.|Mean of 6- and 12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).||units on a scale||Standard Deviation|Mean
833069|NCT01261390|Secondary|Change in Epworth Sleepiness Scale (ESS) (4 Arm)|The Epworth Sleepiness Scale (ESS) is a scale intended to measure daytime sleepiness. The ESS score ranges from 0 - 24, with higher scores indicating increasing possibility of specific sleep disorders. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.|Mean of 6- and 12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).||units on a scale||Standard Deviation|Mean
833070|NCT01261390|Secondary|Change in 36-Item Short Form Survey (SF-36) Measures (4 Arm)|The 36-Item Short Form Survey (SF-36) is a patient-reported survey of patient health. The SF-36 scores range from 0-100, with lower scores indicating greater disability. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.|Mean of 6- and 12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).||units on a scale||Standard Deviation|Mean
833071|NCT01261390|Primary|Change From Baseline in 24-hour Blood Pressure at Month 6 (4 Arms)|Blood pressure data was collected using a 24-hour ambulatory blood pressure monitor. Outcome reported is mean change from baseline to 6-months.|6-months|Intent to treat population (all individuals who were randomized to a treatment arm) who had valid measurements of ambulatory blood pressure for baseline and 6 Month follow-up. Number analyzed differs between rows due to individuals having insufficient readings during wake and/or sleep.||mmHg||Standard Deviation|Mean
833072|NCT01261390|Primary|Change From Baseline in 24-hour Blood Pressure at Month 12 (4 Arms)|Blood pressure data was collected using a 24-hour ambulatory blood pressure monitor. Outcome reported is mean change from baseline to 12-months.|12-months|Intent to treat population (all individuals who were randomized to a treatment arm) who had valid measurements of ambulatory blood pressure for baseline and 12 Month follow-up. Number analyzed differs between rows due to individuals having insufficient readings during wake and/or sleep.||mmHg||Standard Deviation|Mean
833073|NCT01261390|Primary|Change From Baseline in 24-hour Blood Pressure at Month 6 by Pooled Arms|Blood pressure data was collected using a 24-hour ambulatory blood pressure monitor. The 2 Active arms and 2 Control arms were pooled to create a 2-arm analysis. Outcome reported mean change from baseline to 6-months. Control arms and Active arms were pooled, respectively, for analysis.|6-months|Intent to treat population (all individuals who were randomized to a treatment arm) who had valid measurements of ambulatory blood pressure for baseline and 6 Month follow-up. Number analyzed differs between rows due to individuals having insufficient readings during wake and/or sleep.||mmHg||Standard Deviation|Mean
833074|NCT01261390|Primary|Change From Baseline in 24-hour Blood Pressure at Month 12 by Pooled Arms|Blood pressure data was collected using a 24-hour ambulatory blood pressure monitor. The 2 Active arms and 2 Control arms were pooled to create a 2-arm analysis. Outcome reported is change from baseline to 12-months. Control arms and Active arms were pooled, respectively, for analysis.|12-months|Intent to treat population (all individuals who were randomized to a treatment arm) who had valid measurements of ambulatory blood pressure for baseline and 12 Month follow-up. Number analyzed differs between rows due to individuals having insufficient readings during wake and/or sleep.||mmHg||Standard Deviation|Mean
833075|NCT01261390|Primary|Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 (4 Arms)|Blood pressure data was collected using a 24-hour ambulatory blood pressure monitor. Average of changes from baseline to 6 months and from baseline to 12 months.|Mean of 6- and 12-months|Intent to treat population (all individuals who were randomized to a treatment arm) who had valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Number analyzed differs between rows due to individuals having insufficient readings during wake and/or sleep.||mmHg||Standard Deviation|Mean
833076|NCT01261390|Primary|Difference in CPAP Adherence by Active Treatment Arm|Adherence to CPAP therapy was tracked remotely by modem transmission. Outcome reported is mean hours of PAP use per night at the 6-month timepoint. Comparison is between those with and without assignment to Motivational Enhancement as part of treatment randomization.|6-months|Intent to treat population for those assigned to Active PAP (all individuals who were randomized to one of the two PAP arms).||hours/night||Standard Deviation|Mean
833077|NCT01261390|Primary|Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 by Pooled Arms|Blood pressure data was collected using a 24-hour ambulatory blood pressure monitor. The 2 Active arms and 2 Control arms were pooled to create a 2-arm analysis. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months. Control arms and Active arms were pooled, respectively, for analysis.|Mean of 6- and 12-months|Intent to treat population (all individuals who were randomized to a treatment arm) who had valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint.||mmHg||Standard Deviation|Mean
833078|NCT01261507|Secondary|False Positive Decisions of Radiologists|This is a comparison of the radiologists working without and with the software. The false positive rate is the percentage of cases in which the radiologists identified a lesions/location suspected of being cancer at a location where cancer was not present. . A false positive represents a location selected on a chest image without cancer and, also, a mark on a chest image where cancer was present, but a different location, one without cancer, was marked.The radiologists could mark up to five locations on an image and had to provide a confidence rating for each. This analysis is of the single mark with the highest confidence level.|1 day|||percentage of marks not on cancers||Standard Error|Mean
833079|NCT01261507|Secondary|Sensitivity and Specificity|Sensitivity and specificity will be measured. If the radiologists using the new software have higher sensitivity, statistically significant at the p=< 0.05, the use of the new software will be considered to have resulted in improvement. A decrease in specificity is expected.|1 day|||Percentage of cases||Standard Error|Mean
833080|NCT01261507|Primary|Localized Receiver Operating Characteristic (LROC) Comparison|"The area under the LROC curve will be compared for the chest radiograph interpretations done without the new software and those done with the new software. Improvement will be demonstrated if the improvement with the new software is statistically significant at the p=<0.05. There were 422 cases in the total study. 20 of these were inserted as noise cases, not to be analyzed. Thus there were 402 cases to be analyzed. There were 120 cases with nodules and 282 without a nodule. LROC is a method for measuring the success or failure of a method where there is a tradeoff between the detection of lung nodules that are there (true positives) and the detection that the radiologist considers to be a nodule where no nodule is present (false positive). It yields a single number that done not have a unit of measurement."|1 day|All participants were included for calculation of A-LROC and Sensitivity-Specificity. All radiographs were interpreted both without and with software assistance||unitless|Participants|Standard Error|Mean
834042|NCT01263509|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 20).|The change between the value of fasting plasma glucose collected at week 20 and fasting plasma glucose collected at baseline.|Baseline and Week 20.|Values are Summary Statistics.||mg/dL||Standard Deviation|Mean
833081|NCT01261559|Primary|Relative Skin Entrance Radiation Dose in % During Computed Tomography (CT)|Relative skin entrance dose at the breast (group mean of patient's average skin entrance dose at TLDs 2-4) divided by skin entrance dose at the inframammary TLD (TLD 1) in %. For each patient, doses at TLDs 2-4 were averaged, and then the group mean of this was divided by the group mean at the inframammary TLD, then multiplied by 100 to get % dose. A relative dose of 20% means that the skin entrance dose at the breast was 20% of the skin entrance dose at the inframammary fold.|from time potential subject approached about possible enrollment to time device and TLDs were removed, on average 1 hour|||percentage of dose||Standard Deviation|Mean
833082|NCT01261559|Secondary|CT Image Noise and Image Quality|CT images acquired will be reviewed for the presence of artifacts and interrogated for image noise|two months||||||
833083|NCT01261559|Primary|Skin Entrance Radiation Dose During Computed Tomography (CT)|Skin entrance radiation doses will be measured with Thermoluminescent dosimeters (TLDs) affixed to the subject's chest and breast during CT of the abdomen. TLD #1 is at the inframammary fold, serving as internal control for each subject. Three additional TLDs (#2-4) are affixed to the subject's breast at 3 pre-ascribed locations. The same is done for the right and left breasts (8 TLDs total). TLDs will then be submitted to Landaeur for measurement.|from time potential subject approached about possible enrollment to time device and TLDs were removed, on average 1 hour|||mrad||Standard Deviation|Mean
833084|NCT01264380|Secondary|Overall Survival (OS)|OS was defined as the time, in months, from the date of the first study drug to the date of death, regardless of the cause of death.|From Baseline then Day 1 of Cycle 3 and 5 (21-day cycle) at Period C thereafter every 2 cycles until Cycle 12 followed by every 4 cycles from Cycle 13 until death (Up to Week 124)|Data for OS was not collected as there was a change in planned analysis, not to collect the data.|||||
833085|NCT01264380|Secondary|Percentage of Participants With Best Objective Response (BOR) as Complete Response (CR) or Partial Response (PR)|BOR was defined as the best objective response assessed by investigator during the treatment period according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. BOR was the best response recorded from the start of the study treatment until the end of treatment taking into account any requirement for confirmation. It is defined as the number of participants whose best objective response was complete response (CR) or partial response (PR) divided by the total number of efficacy evaluable participants. CR: disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes (whether target or non-target) were non-pathological in size (less than [<] 10 millimeter [mm] short axis). PR: at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|From Baseline then Day 1 of Cycle 3 and 5 (21-day cycle) at Period C thereafter every 2 cycles until Cycle 12 followed by every 4 cycles from Cycle 13 until disease progression or death (Up to Week 124)|Intent-to-treat (ITT) population included participants with measurable disease who received at least 1 dose of vemurafenib. Here “number of participants analyzed”=participants who were evaluable for this outcome measure.||percentage of participants||95% Confidence Interval|Number
833086|NCT01264380|Primary|Apparent First-order Terminal Elimination Rate Constant (Kel) in the Fasted and Fed States|Apparent first-order terminal elimination rate constant (kel), was calculated as the negative slope of the linear regression of the terminal phase in plasma vemurafenib concentration-time profile using specific appropriate time points. PK analyses was performed after the completion of Period A and Period B of this study for all participants.|Period A: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16 h pd on Day 1; 24, 36, 48, 72, 96, 144, 192, and 240 h pd and Period B: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16 h pd on Day 11; 24, 36, 48, 72, 96, 144, 192, and 240 h pd|"PK analysis population. Here number of participants analyzed=participants who were evaluable for this outcome measure."||1/h||Standard Deviation|Mean
833087|NCT01264380|Primary|Terminal Elimination Half-Life (t1/2) in the Fasted and Fed States|T1/2 is the time required for the concentration of the drug to reach half of its original value. PK analyses was performed after the completion of Period A and Period B of this study for all participants.|Period A: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16 h pd on Day 1; 24, 36, 48, 72, 96, 144, 192, and 240 h pd and Period B: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16 h pd on Day 11; 24, 36, 48, 72, 96, 144, 192, and 240 h pd|PK analysis population. Here “number of participants analyzed”=participants who were evaluable for this outcome measure.||hour||Standard Deviation|Mean
833088|NCT01264380|Primary|Time to Reach Maximal Plasma Concentration (Tmax) in the Fasted and Fed States|PK analyses was performed after the completion of Period A and Period B of this study for all participants.|Period A: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16 h pd on Day 1; 24, 36, 48, 72, 96, 144, 192, and 240 h pd and Period B: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16 h pd on Day 11; 24, 36, 48, 72, 96, 144, 192, and 240 h pd|PK analysis population.||hour||Full Range|Median
833089|NCT01264380|Primary|Minimum Observed (Trough) Plasma Concentration (Cmin) in the Fasted and Fed States|Single dose Pre-dose concentration is referred as Cmin here. PK analyses was performed after the completion of Period A and Period B of this study for all participants.|Pre-dose on Periods A and B|PK analysis population.||µg/mL||Standard Deviation|Mean
833090|NCT01264380|Primary|Maximal Observed Plasma Concentration (Cmax) in the Fasted and Fed States|PK analyses was performed after the completion of Period A and Period B of this study for all participants.|Period A: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16 h pd on Day 1; 24, 36, 48, 72, 96, 144, 192, and 240 h pd and Period B: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16 h pd on Day 11; 24, 36, 48, 72, 96, 144, 192, and 240 h pd|PK analysis population.||µg/mL||Standard Deviation|Mean
833091|NCT01264380|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Sample With Last Measurable Concentration (AUC[0-last]) in the Fasted and Fed States|PK analyses was performed after the completion of Period A and Period B of this study for all participants.|Period A: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16 h pd on Day 1; 24, 36, 48, 72, 96, 144, 192, and 240 h pd and Period B: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16 h pd on Day 11; 24, 36, 48, 72, 96, 144, 192, and 240 h pd|PK analysis population. Here “number of participants analyzed”=participants who were evaluable for this outcome measure.||µg*h/mL||Standard Deviation|Mean
833159|NCT01265498|Secondary|Change in Fasting Serum Glucose||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.||mmol/L||Standard Deviation|Mean
833092|NCT01264380|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC [0-inf]) in the Fasted and Fed States|Pharmacokinetic (PK) analyses was performed after the completion of Period A and Period B of this study for all participants.|Period A: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16 hours (h) post-dose (pd) on Day 1; 24, 36, 48, 72, 96, 144, 192, and 240 h pd and Period B: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16 h pd on Day 11; 24, 36, 48, 72, 96, 144, 192, and 240 h pd|PK analysis population included participants who received both single doses of vemurafenib in Periods A and B without protocol violation and provided adequate PK assessments to calculate important PK parameters. Here “number of participants analyzed”=participants who were evaluable for this outcome measure.||micrograms*hour per milliliter (µg*h/mL)||Standard Deviation|Mean
833093|NCT01264614|Primary|Neurophysiological Function Pre- & Post- Intervention|Resting EEG and ERP recordings before (T1) and after (T2) strengthening exercise intervention|Baseline and 3 months||||||
833094|NCT01264614|Primary|Figure Copy & Delayed Test Performance From Pre- to Post-intervention|Average raw cognitive scores before (T1) and after (T2) strengthening exercise intervention. Higher scores represent better performance (Figure Copy & Delayed possible score range is 0-36 points).|Baseline and 3 months|Two of 9 normative participants, had to be dropped from analyses due to limited participation in the exercise program (less than once per week on average; health problems and snowy weather were the main limiting factors) and one dementia exerciser was dropped because he did not complete any of the outcome measures.||Points||Standard Deviation|Mean
833095|NCT01264614|Primary|Fuld Test Performance From Pre- to Post-intervention|Average raw cognitive scores before (T1) and after (T2) strengthening exercise intervention. Higher scores represent better performance (Fuld Semantic Recall possible score range is 0-20 points; Fuld Immediate and Delayed Recall possible score range is 0-10).|Baseline and 3 months|Two of 9 normative participants, had to be dropped from analyses due to limited participation in the exercise program (less than once per week on average; health problems and snowy weather were the main limiting factors) and one dementia exerciser was dropped because he did not complete any of the outcome measures.||Points||Standard Deviation|Mean
833096|NCT01264614|Primary|Color Trails Test Performance From Pre- to Post-intervention|Average raw cognitive scores before (T1) and after (T2) strengthening exercise intervention. Higher scores represent better performance (Color Trails possible score range is 0-300 seconds).|Baseline and 3 months|Two of 9 normative participants, had to be dropped from analyses due to limited participation in the exercise program (less than once per week on average; health problems and snowy weather were the main limiting factors) and one dementia exerciser was dropped because he did not complete any of the outcome measures.||Time to complete (seconds)||Standard Deviation|Mean
833097|NCT01264614|Primary|Digits Backwards Test Performance From Pre- to Post-intervention|Average raw cognitive scores before (T1) and after (T2) strengthening exercise intervention. Higher scores represent better performance (Digits backwards possible score range is 0-14 points).|Baseline and 3 months|Two of 9 normative participants, had to be dropped from analyses due to limited participation in the exercise program (less than once per week on average; health problems and snowy weather were the main limiting factors) and one dementia exerciser was dropped because he did not complete any of the outcome measures.||Points||Standard Deviation|Mean
833098|NCT01264614|Primary|Stroop Test Performance From Pre- to Post-intervention|Average raw cognitive scores before (T1) and after (T2) strengthening exercise intervention. Lower scores on Stroop C (possible range 0-240 sec) represents better performance).|Baseline and 3 months|Two of 9 normative participants, had to be dropped from analyses due to limited participation in the exercise program (less than once per week on average; health problems and snowy weather were the main limiting factors) and one dementia exerciser was dropped because he did not complete any of the outcome measures.||Time to complete (seconds)||Standard Deviation|Mean
833099|NCT01264770|Secondary|SF-36 - Comparison of the Change in MCS From Baseline Between Fostamatinib and Adalimumab at Week 24|SF-36: 36-item Short Form Health Survey, a measure of health-related QoL. Scores for 8 sub-domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Function, Role-Emotional & Mental Health) are derived & normalised to a scale of 0-100. Physical & Mental Component Scores (PCS & MCS) are derived by multiplying each of these 8 scores by a constant, summing them & standardising against a population with mean of 50, standard deviation of 10. Higher scores represent a better QoL. Mean changes from baseline score are presented at each visit as increases from baseline (defined as post-baseline minus baseline); larger changes indicate a better clinical condition. Non-responder imputation applied by carrying the baseline observation forward. ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, LS = least squares, PO = orally, QD = once a day, QoL = quality of life, SC = subcutaneous.|Baseline and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle. In line with the study objectives, fostamatinib was compared with adalimumab (not placebo) at Week 24.||Units on a scale||Standard Deviation|Mean
833100|NCT01264770|Secondary|SF-36 - Comparison of the Change in PCS From Baseline Between Fostamatinib and Adalimumab at Week 24|SF-36: 36-item Short Form Health Survey, a measure of health-related QoL. Scores for 8 sub-domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Function, Role-Emotional & Mental Health) are derived & normalised to a scale of 0-100. Physical & Mental Component Scores (PCS & MCS) are derived by multiplying each of these 8 scores by a constant, summing them & standardising against a population with mean of 50, standard deviation of 10. Higher scores represent a better QoL. Mean changes from baseline score are presented at each visit as increases from baseline (defined as post-baseline minus baseline); larger changes indicate a better clinical condition. Non-responder imputation applied by carrying the baseline observation forward. ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, LS = least squares, PO = orally, QD = once a day, QoL = quality of life, SC = subcutaneous.|Baseline and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle. In line with the study objectives, fostamatinib was compared with adalimumab (not placebo) at Week 24.||Units on a scale||Standard Deviation|Mean
834043|NCT01263509|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 16).|The change between the value of fasting plasma glucose collected at week 16 and fasting plasma glucose collected at baseline.|Baseline and Week 16.|Values are Summary Statistics.||mg/dL||Standard Deviation|Mean
833101|NCT01264770|Secondary|HAQ-DI - Comparison of the Change From Baseline Between Fostamatinib and Adalimumab at Week 24|HAQ-DI: Health Assessment Questionnaire - Disability Index, a measure of physical function. The HAQ-DI score is calculated by summing the category scores from 8 sub-categories (ie, scores for patient ability in dressing and grooming, rising, eating, walking, hygiene, reach, grip and common daily activities) and dividing by the number of categories completed. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability. Non-responder imputation has been applied by carrying the baseline observation forward. ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, LS = least squares, n/a = not applicable, PO = orally, qd = once a day, SC = subcutaneous.|Baseline and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle. In line with the study objectives, fostamatinib was compared with adalimumab (not placebo) at Week 24.||Units on a scale||Standard Deviation|Mean
833102|NCT01264770|Secondary|HAQ-DI - Comparison of the Change From Baseline Between Fostamatinib and Placebo at Week 6|HAQ-DI: Health Assessment Questionnaire - Disability Index, a measure of physical function. The HAQ-DI score is calculated by summing the category scores from 8 sub-categories (ie, scores for patient ability in dressing and grooming, rising, eating, walking, hygiene, reach, grip and common daily activities) and dividing by the number of categories completed. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability. Non-responder imputation has been applied by carrying the baseline observation forward. ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, LS = least squares, n/a = not applicable, PO = orally, qd = once a day, SC = subcutaneous.|Baseline and 6 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle. In line with the study objectives, fostamatinib was compared with placebo (not adalimumab) at Week 6.||Units on a scale||Standard Deviation|Mean
833103|NCT01264770|Secondary|ACRn - Comparison Between Fostamatinib and Adalimumab at Week 24|ACRn: American College of Rheumatology Index of RA improvement, based on smallest percentage improvement in the count of swollen joints (out of 28 joints), count of tender joints (out of 28 joints) or in blood test measures of inflammation (such as CRP) or the physician and patient's own asessment of disease activity, pain and physical function. Scores are reported as a percentage improvement on a scale of -100 to +100, with larger values representing a better clinical outcome. Non-responder imputation has been applied by carrying the baseline observation forward. BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, n/a = not applicable, PO = orally, qd = once a day, SC = subcutaneous. Mean refers to change at Week 24. Treatment difference: difference between fostamatinib and adalimumab groups.|Baseline and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.In line with the study objectives, fostamatinib was compared with adalimumab (not placebo) at Week 24.||Percentage improvement from baseline||Standard Deviation|Mean
833104|NCT01264770|Secondary|ACRn - Comparison Between Fostamatinib and Placebo at Week 6|ACRn: American College of Rheumatology Index of RA improvement, based on smallest percentage improvement in the count of swollen joints (out of 28 joints), count of tender joints (out of 28 joints) or in blood test measures of inflammation (such as CRP) or the physician and patient's own asessment of disease activity, pain and physical function. Scores are reported as a percentage improvement on a scale of -100 to +100, with larger values representing a better clinical outcome. Non-responder imputation has been applied by carrying the baseline observation forward. BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, n/a = not applicable, PO = orally, qd = once a day, SC = subcutaneous. Mean refers to change at Week 6. Treatment difference: difference between fostamatinib and placebo groups.|Baseline and 6 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle. In line with the study objectives, fostamatinib was compared with placebo (not adalimumab) at Week 6.||Percentage improvement from baseline||Standard Deviation|Mean
833105|NCT01264770|Secondary|Proportion of Patients Achieving ACR70 up to Week 24|ACR70: American College of Rheumatology 70% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function. Non-responder imputation has been applied by carrying the baseline observation forward. BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, n/a = not applicable, PO = orally, qd = once a day, SC = subcutaneous.|6 and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle. In line with the study objectives, fostamatinib was compared with placebo (not adalimumab) at Week 6 and with adalimumab (not placebo) at Week 24.||Percentage of responders|||Number
833106|NCT01264770|Secondary|Proportion of Patients Achieving ACR50 up to Week 24|ACR50: American College of Rheumatology 50% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function. Non-responder imputation has been applied by carrying the baseline observation forward. BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, n/a = not applicable, PO = orally, qd = once a day, SC = subcutaneous.|6 and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle. In line with the study objectives, fostamatinib was compared with placebo (not adalimumab) at Week 6 and with adalimumab (not placebo) at Week 24.||Percentage of responders|||Number
833160|NCT01265498|Secondary|Change in International Normalised Ratio||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.||ratio||Standard Deviation|Mean
833107|NCT01264770|Secondary|Proportion of Patients Achieving ACR20 up to Week 24|ACR20: American College of Rheumatology 20% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function. Non-responder imputation has been applied by carrying the baseline observation forward. BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, n/a = not applicable, PO = orally, qd = once a day, SC = subcutaneous.|6 and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle. In line with the study objectives, fostamatinib was compared with placebo (not adalimumab) at Week 6 and with adalimumab (not placebo) at Week 24.||Percentage of responders|||Number
833108|NCT01264770|Secondary|DAS28 EULAR Response at Week 24|Change in DAS28 was derived for each post baseline scheduled assessment and categorised using the European League Against Rheumatism (EULAR) response criteria. Non-responder imputation has been applied by carrying the baseline observation forward. bid = twice daily, DAS28 = Disease Activity Score based on a 28-joint count, DMARD = disease-modifying anti-rheumatic drug, OR = odds ratio, PO = orally, qd = once a day, SC = subcutaneous.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle. In line with the study objectives, fostamatinib was compared with adalimumab (not placebo) at Week 24.||Percentage of responders|||Number
833109|NCT01264770|Secondary|DAS28 EULAR Response at Week 6|Change in DAS28 was derived for each post baseline scheduled assessment and categorised using the European League Against Rheumatism (EULAR) response criteria. Non-responder imputation has been applied by carrying the baseline observation forward. bid = twice daily, DAS28 = Disease Activity Score based on a 28-joint count, DMARD = disease-modifying anti-rheumatic drug, OR = odds ratio, PO = orally, qd = once a day, SC = subcutaneous.|6 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle. In line with the study objectives, fostamatinib was compared with placebo (not adalimumab) at Week 6.||Percentage of responders|||Number
833110|NCT01264770|Primary|DAS28-CRP Score - Change From Baseline to Week 24 Compared to Adalimumab|DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patient's own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. Mean changes from baseline in DAS28-CRP score are shown at each visit and are presented as decreases from baseline (defined as baseline minus post-baseline) with larger changes indicative of a better clinical condition. Non-responder imputation has been applied by carrying the baseline observation forward. ANCOVA = analysis of covariance, BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, LS = least squares, n/a = not applicable, PO = orally, QD = once a day, SC = subcutaneous.|Baseline and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle. In line with the study objectives, fostamatinib was compared with adalimumab (not placebo) at Week 24.||Units on a scale||Standard Deviation|Mean
833111|NCT01264770|Primary|DAS28-CRP Score - Change From Baseline to Week 6 Compared to Placebo|DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patient's own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. Mean changes from baseline in DAS28-CRP score are shown at each visit and are presented as decreases from baseline (defined as baseline minus post-baseline) with larger changes indicative of a better clinical condition. ANCOVA = analysis of covariance, BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, LS = least squares, n/a = not applicable, PO = orally, QD = once a day, SC = subcutaneous.|Baseline and 6 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle. In line with the study objectives, fostamatinib was compared with placebo (not adalimumab) at Week 6.||Units on a scale||Standard Deviation|Mean
833112|NCT01264835|Primary|Procedure Duration (Surgery Time)|Procedure duration was defined as the length of time in minutes from first insertion of the slotted anoscope to final removal of the slotted anoscope.|Time of surgery|No analyses are being reported for this outcome measure as this trial was terminated early. The procedure was only performed with the slotted anoscope in 1 subject. No assessment or analysis of primary or secondary objectives was performed.||minutes||Standard Deviation|Mean
833113|NCT01264887|Primary|Time Dependence of Adverse Events|The onset and duration of TEAEs was not evaluated for this trial.|Day 1; 144 weeks||||||
833114|NCT01264887|Secondary|Tapentadol Prolonged Release Exposure|The number of days that participants took tapentadol prolonged release. The extent of exposure was categorized into 2 periods, less than 90 days and more than 90 days (up to 144 weeks).|Day 1; up to 144 weeks|Safety Set.||participants|||Number
833115|NCT01264887|Other Pre-specified|Average Daily Total Tapentadol Prolonged Release Dose|The Total Daily Dose (TDD) on any given day is the sum of the morning and evening intake amounts. The average TDD is an individuals average over the trial period.|Day 1; up to 144 weeks|Safety Set.||mg per day||Standard Deviation|Mean
833116|NCT01264887|Other Pre-specified|Average Pain Intensity (Over a Twelve-week Period)|"The participant scored their pain intensity on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine.
Average pain intensity score is the average of pain experienced for previous 24 hours as rated on an 11-point NRS at each visit. Calculations are based on 3 consecutive planned (at 4-weekly intervals) visits.
All available data of a participant was used; if a participant dropped-out or had incomplete data during a 12-week period no imputations were performed for the missing values."|Day 1; up to Week 144|Safety Set.||units on a scale||Standard Deviation|Mean
833117|NCT01264887|Primary|Countermeasures Taken Due to Treatment Emergent Adverse Events|Participant-based analysis of treatment emergent adverse events (TEAEs) regarding countermeasure to the study drug (tapentadol). The TEAEs were reported by the participants or were captured by the investigator. The countermeasure taken by the investigator were reported.|Day 1; up to 144 weeks|Safety Set.||participants|||Number
833118|NCT01264887|Primary|Relatedness Assessment of Treatment Emergent Adverse Events|Participant-based analysis of treatment emergent adverse events (TEAEs) regarding the relationship to the study drug (tapentadol). The TEAEs were reported by the participants or were captured by the investigator. The relationship was rated by the investigator. The categorization of relatedness into one of the two categories was based on the following: Related included “possible”, “probable/likely”, and “certain”; whilst unrelated treatment emergent adverse events include those rated by the investigator as “unlikely”, “conditional/unclassified”, “un-assessable/unclassifiable”, and “not related”.|Day 1; up to 144 weeks|Safety Set.||participants|||Number
833119|NCT01264887|Secondary|Assess Consumption of Tapentadol During Long Term Use|Summary of the modal total daily dose during the treatment period. The modal dose was based on assessment of the consecutive morning and evening intake amounts on each day and evaluation of the total daily dose.|Day 1; up to 144 weeks|"The modal dose is based on assessment of the consecutive morning and evening intake amounts on each day and evaluation of the total daily dose.
No participant received more than 500 mg per day."||participants|||Number
833120|NCT01264887|Primary|Severity of Adverse Events|"The severity of treatment emergent adverse events was any untoward medical occurrence in a patient administered tapentadol. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of the (investigational) medicinal product whether or not related to the use of tapentadol.
The clinical “intensity” of adverse event were classified as:
Mild: signs and symptoms which can be easily tolerated. Symptoms could be ignored and disappeared when the participant is distracted.
Moderate: symptoms caused discomfort but were tolerable, they could not be ignored and affect concentration.
Severe: symptoms affected the usual daily activity."|Day 1; up to 144 weeks|Safety Set.||participants|||Number
833121|NCT01264939|Primary|Percentage of Participants With Adverse Events|The percentage of participants with serious adverse events and other adverse events is summarized by MedDRA preferred terms and organ classes in the Reported Adverse Events section below.|Baseline to the end of study (up to 40 weeks)|Safety population: All randomized participants who received at least 1 dose of study drug.||Percentage of participants|||Number
833122|NCT01264939|Secondary|Percentage of Complete Responders (UAS7 = 0) at Week 12|A complete responder was defined as a participant with a UAS7 score = 0 at Week 12. The UAS7 is the sum of the daily urticarial activity scores over 7 days and ranges from 0 to 42. The daily urticarial activity score is the average of the morning and evening urticarial activity scores and ranges from 0 to 6. The urticarial activity score is the sum of ratings on a scale of 0 to 3 (0=none to 3=intense/severe) for (1) the number of wheals (hives) and (2) itch intensity over the previous 12 hours, ranges from 0 to 6, and is measured twice daily (morning and evening). The Baseline score is the sum of the daily urticarial activity scores over the 7 days prior to the first treatment. A higher urticarial activity score indicates more urticaria activity.|Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.||Percentage of participants|||Number
833123|NCT01264939|Secondary|Percentage of Angioedema-free Days From Week 4 to Week 12|The percentage of angioedema-free days from Weeks 4 to 12 was defined as the number of days for which a patient responded “No” to the angioedema question in the daily diary divided by the total number of days with a non-missing diary entry, starting at the Week 4 visit and ending the day prior to the Week 12 visit.|Week 4 to Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug. Patients who withdrew before the Week 4 visit or who had missing responses for more than 40% of the daily diary entries between the Week 4 visit and the Week 12 visit were not included in the analysis.||Percentage of days||Standard Deviation|Mean
833124|NCT01264939|Secondary|Change From Baseline in the Overall Dermatology Life Quality Index (DLQI) Score at Week 12|The DLQI is a 10-item dermatology-specific health-related quality of life measure. Patients rated their dermatology symptoms as well as the impact of their skin condition on various aspects of their lives on a scale of 0 (Not at all) to 3 (Very much). The overall DLQI is the sum of the responses to the 10 items and ranges from 0 to 30. A lower score indicates a better quality of life. A negative change score indicates improvement.|Baseline to Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug and who had a DLQI score at Week 12.||Units on a scale||Standard Deviation|Mean
833125|NCT01264939|Secondary|Change From Baseline to Week 12 in the Weekly Size of the Largest Hive Score|The weekly size of the largest hive score is the sum of the daily size of the largest hive scores over 7 days and ranges from 0 to 21. The daily size of the largest hive score is assessed twice daily (morning and evening) on a scale of 0 (none) to 3 (> 2.5 cm). The daily size of the largest hive score is the average of the morning and evening scores. The Baseline weekly size of the largest hive score is calculated over the 7 days prior to the first treatment. A higher score indicates larger hives. A negative change score indicates a reduction in hive size.|Baseline to Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.||Units on a scale||Standard Deviation|Mean
833126|NCT01264939|Secondary|Percentage of Weekly Itch Severity Score MID Responders at Week 12|The percentage of participants with an itch severity score at 12 Weeks at least 5 points lower than at Baseline. The weekly itch severity score is the sum of the daily itch severity scores over 7 days and ranges from 0 to 21. The daily itch severity score is the average of the morning and evening scores on a scale of 0 (none) to 3 (severe). The Baseline weekly itch severity score is the sum of the daily itch severity scores over the 7 days prior to the first treatment. A higher itch severity score indicates more severe itching.|Baseline to Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.||Percentage of participants|||Number
833127|NCT01264939|Secondary|Percentage of Participants With a UAS7 Score ≤ 6 at Week 12|The UAS7 is the sum of the daily urticarial activity scores over 7 days and ranges from 0 to 42. The daily urticarial activity score is the average of the morning and evening urticarial activity scores and ranges from 0 to 6. The urticarial activity score is the sum of ratings on a scale of 0 to 3 (0=none to 3=intense/severe) for (1) the number of wheals (hives) and (2) itch intensity over the previous 12 hours, ranges from 0 to 6, and is measured twice daily (morning and evening). The Baseline score is the sum of the daily urticarial activity scores over the 7 days prior to the first treatment. A higher urticarial activity score indicates more urticaria activity.|Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.||Percentage of participants|||Number
833128|NCT01264939|Secondary|Time to Minimally Important Difference (MID) Response in the Weekly Itch Severity Score by Week 12|The time to the MID response is the number of weeks from the start of treatment (Baseline) until the time point at which the first MID response occurs. The MID response is defined as a reduction ≥ 5 points from Baseline in the weekly itch severity score. The weekly itch severity score is the sum of the daily itch severity scores over 7 days and ranges from 0 to 21. The daily itch severity score is the average of the morning and evening scores on a scale of 0 (none) to 3 (severe). The Baseline weekly itch severity score is the sum of the daily itch severity scores over the 7 days prior to the first treatment. A higher itch severity score indicates more severe itching.|Baseline to Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug. Only patients with a MID response were included in the analysis.||Weeks||95% Confidence Interval|Median
833129|NCT01264939|Secondary|Change From Baseline to Week 12 in the Weekly Number of Hives Score|The weekly hives score is the sum of the daily hives scores over 7 days and ranges from 0 to 21. The number of hives is measured twice daily (morning and evening) on a scale of 0 (none) to 3 (> 12 hives per 12 hours). The daily hives score is the average of the morning and evening scores. The Baseline score is the sum of the daily hives scores over the 7 days prior to the first treatment. A higher score indicates more hives. A negative change score indicates improvement.|Baseline to Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.||Units on a scale||Standard Deviation|Mean
833130|NCT01264939|Secondary|Change From Baseline to Week 12 in the Urticaria Activity Score Over 7 Days (UAS7)|The UAS7 is the sum of the daily urticarial activity scores over 7 days and ranges from 0 to 42. The daily urticarial activity score is the average of the morning and evening urticarial activity scores and ranges from 0 to 6. The urticarial activity score is the sum of ratings on a scale of 0 to 3 (0=none to 3=intense/severe) for (1) the number of wheals (hives) and (2) itch intensity over the previous 12 hours, ranges from 0 to 6, and is measured twice daily (morning and evening). The Baseline score is the sum of the daily urticarial activity scores over the 7 days prior to the first treatment. A higher urticarial activity score indicates more urticaria activity. A negative change score indicates improvement.|Baseline to Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.||Units on a scale||Standard Deviation|Mean
833131|NCT01264939|Secondary|Change From Baseline to Week 12 in the Weekly Itch Severity Score|The weekly itch severity score is the sum of the daily itch severity scores over 7 days and ranges from 0 to 21. The daily itch severity score is the average of the morning and evening scores on a scale of 0 (none) to 3 (severe). The Baseline weekly itch severity score is the sum of the daily itch severity scores over the 7 days prior to the first treatment. A higher itch severity score indicates more severe itching. A negative change score indicates improvement.|Baseline to Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.||Units on a scale||Standard Deviation|Mean
833132|NCT01264952|Primary|Evaluation of Toxicity Related to Electrochemotherapy (Toxicity, Symptoms)||After operation on day 7|||Toxicity, symptoms|||Number
833133|NCT01264952|Secondary|Treatment Evaluation of Tumor Response - Measurements of Tumor Lesions by Contrast Enhanced Ultrasonography (US-Doppler), Magnetic Resonance Imaging (MRI), Computed Tomography (CT), Histology||After operation or 1st day after operation, 7th day, 30th day, monthly|||complete response (CR)|Participants||Number
833134|NCT01264952|Secondary|Clinical Evaluation of the Patient (Pain Scale, Adverse Events, Concomitant Treatment)||After operation on tha days 2, 7, 30, monthly|||patients with non-severe adverse events|||Number
833135|NCT01265056|Secondary|To Determine the Impact of Psychological Functioning in Patients Following Admission for Their Burn Injury. This Will be Determined by Review of Two Forms (the Brief Symptom Inventory and the Sickness Impact Profile).||From time of enrollment to 2 weeks after being discharge||||||
833136|NCT01265056|Secondary|To Determine the Trends in Several Associated Clinical Effects of Opioid Administration Between the Treatment and the Control Groups. These Effects Include: 1. Fluid Resusitation 2. Insulin Resistance 3. Hospital Associated Infections||From time of enrollment to 2 weeks after being discharge||||||
833137|NCT01265056|Primary|To Determine the Trends in Opioid Consumption Between the Treatment and the Control Groups.||From time of enrollment to 2 weeks after being discharged|This was an intention to treate analysis. We measured the oral morphine equivalents both groups were administered.||mg||Standard Deviation|Mean
833138|NCT01265394|Secondary|Measurement of Amyloid Content in Different Parts of the Brain|"Is the computerized measurement of amyloid content in different parts of the brain.
The Standard Uptake Value Ratio (SUVR) is defined as an average of frontal, anterior cingulate, pariteal, lateral-temporal and posterior cingulate / precuneous uptake following administration of Flutemetamol F18 Injection.
The Standard Uptake Value Ratio is calculated for two regions of the brain, the Cerebullum and the Pons regions.
The Standard Uptake Value Ratio is calculated for two regions of the brain, the Cerebullum and the Pons regions. Both regions of the brain will provide the SUVR measurements."|PET scans performed on patients 90 minutes post Flutemetmol Administration|The Standard Uptake Value Ratio is calculated for two regions of the brain, the Cerebullum and the Pons regions. Both regions of the brain will provide the SUVR measurements.||Standard Uptake Value Ratio ( SUVR)||Standard Deviation|Mean
833139|NCT01265394|Primary|Number of Brain Scans in Healthy Young Adults Subjects Which do Not Show Amyloid|"The visual assessment of Flutemetamol PET image was performed by independent readers trained in the evaluation of PET brain amyloid imaging.
The measure would consisted of the number of brain scans with amyloid (abnormal reading) or without amyloid (normal reading)."|PET scans performed on patients 90 minutes post Flutemetmol Administration|Healthy young adult subjects aged 18 to 40 are presumed to be amyloid negative||Brain Scans Read|||Number
833140|NCT01265420|Primary|Number Patients Obtaining Clinical Improvement (>50% Reduction in Contracture)||30 days after last injection|||participants|||Number
833141|NCT01265446|Secondary|Change From Baseline Sore Throat Pain Intensity up to 240 mn Post-dose|100 milimeter (mm) visual acuity score (left=no pain=0mm, right=worst possible pain=100mm). It measures the highest pain level felt by the patient.|Baseline and 240 mn post-dose|intent to treat||mm||95% Confidence Interval|Mean
833142|NCT01265446|Primary|Change From Baseline Sore Throat Pain Intensity|100 milimeter (mm) visual acuity score (left=no pain=0mm, right=worst possible pain=100mm)|Baseline and 2 hours post-dose|Intent to treat||mm||95% Confidence Interval|Mean
833144|NCT01265459|Secondary|WOMAC Physical Function Score (Change From Baseline)|"The study aims to compare the physical function for different volumes of study product over 26 weeks using WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) physical function score that consists of 17 questions.
It is a 5-graded Likert scale: None, Mild, Moderate, Severe or Extreme relating to performing daily physical activities the subject has experienced in the last 48 hours. The score of each dimension is calculated by simply adding the score (from 0 to 4) for each question."|26 weeks after treatment compared to baseline|||units on a scale||Standard Deviation|Mean
833145|NCT01265459|Secondary|WOMAC Stiffness Score (Change From Baseline)|"The study aims to compare the change of stiffness for different volumes of study product over 26 weeks using WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) stiffness score that consists of 2 questions.
It is a 5-graded Likert scale: None, Mild, Moderate, Severe or Extreme relating to how much stiffness the subject has experienced in the last 48 hours. The score of each dimension is calculated by simply adding the score (from 0 to 4) for each question."|26 weeks after treatment compared to baseline|||units on a scale||Standard Deviation|Mean
833146|NCT01265459|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability From Baseline to 26 Weeks After Treatment.|"Safety and tolerability will be assessed at each clinic visit (Baseline, 2, 6, 12, 18 and 26 weeks). Standard questions was used, Since your last clinical visit have you had any health problems?”."|From baseline to 26 weeks after treatment|||participants|||Number
833147|NCT01265459|Primary|Change of Pain Over 26 Weeks (Change From Baseline)|"The study aims to compare the change of pain for different volumes of study product over 26 weeks using WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) pain score that consists of 5 questions.
It is a 5-graded Likert scale: None, Mild, Moderate, Severe or Extreme relating to how much pain the subject has experienced during the last 48 hours. The score of each dimension is calculated by simply adding the score (from 0 to 4) for each question."|26 weeks after treatment compared to baseline|"The primary population for all efficacy evaluations was the ITT population (all subjects randomized and treated with study product).
No imputation of missing data was done. Analyses presented were based on observed cases."||units on a scale||Standard Deviation|Mean
833148|NCT01265498|Secondary|Change in SF-36 Quality of Life Mental Component Summary|Short Form (36) Health Survey The SF-36 evaluates health-related quality of life in 8 domains consisting of two components: physical and mental. The score for each domain ranges from 0 to 100. Norm based scoring (based on the general US population) is used with a mean of 50 and standard deviation of 10. Higher values represent a better outcome.|baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.||units on a scale||Standard Deviation|Mean
833149|NCT01265498|Secondary|Change in SF-36 Quality of Life Physical Component Summary|Short Form (36) Health Survey The SF-36 evaluates health-related quality of life in 8 domains consisting of two components: physical and mental. The score for each domain ranges from 0 to 100. Norm based scoring (based on the general US population) is used with a mean of 50 and standard deviation of 10. Higher values represent a better outcome.|baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.||units on a scale||Standard Deviation|Mean
833150|NCT01265498|Secondary|Change in Diastolic Blood Pressure||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.||mm Hg||Standard Deviation|Mean
833151|NCT01265498|Secondary|Change in Systolic Blood Pressure||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.||mm Hg||Standard Deviation|Mean
833152|NCT01265498|Secondary|Change in Waist-to-hip Ratio||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.||ratio||Standard Deviation|Mean
833153|NCT01265498|Secondary|Change in Waist Circumference||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.||cm||Standard Deviation|Mean
833154|NCT01265498|Secondary|Change in Body-mass Index||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.||kg/m²||Standard Deviation|Mean
833155|NCT01265498|Secondary|Change in Weight||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.||kg||Standard Deviation|Mean
833156|NCT01265498|Secondary|Change in Glycated Haemoglobin A1c||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.||mmol/mol||Standard Deviation|Mean
833157|NCT01265498|Secondary|Change in HOMA-IR||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.||glucose[mmol/L]× insulin[pmol/L] / 22.5||Standard Deviation|Mean
833158|NCT01265498|Secondary|Change in Insulin||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.||pmol/L||Standard Deviation|Mean
833161|NCT01265498|Secondary|Change in Prothrombin Time||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.||s||Standard Deviation|Mean
833162|NCT01265498|Secondary|Change in Total Protein||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.||gl/L||Standard Deviation|Mean
833163|NCT01265498|Secondary|Change in Albumin||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.||gl/L||Standard Deviation|Mean
833164|NCT01265498|Secondary|Change in Uric Acid||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.||μmol/L||Standard Deviation|Mean
833165|NCT01265498|Secondary|Change in Creatinine||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.||μmol/L||Standard Deviation|Mean
833166|NCT01265498|Secondary|Change in Phosphate||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.||mmol/L||Standard Deviation|Mean
833167|NCT01265498|Secondary|Change in Calcium||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.||mmol/L||Standard Deviation|Mean
833168|NCT01265498|Secondary|Change in Bicarbonate||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.||mmol/L||Standard Deviation|Mean
833169|NCT01265498|Secondary|Change in Platelet Count||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.||platelets *10^9 per L||Standard Deviation|Mean
833170|NCT01265498|Secondary|Change in White Blood Cell Count||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.||white blood cells *10^9 per L||Standard Deviation|Mean
833171|NCT01265498|Secondary|Change in Mean Corpuscular Volume||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.||fL||Standard Deviation|Mean
833172|NCT01265498|Secondary|Change in Haematocrit||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.||proportion of 1.0||Standard Deviation|Mean
833173|NCT01265498|Secondary|Change in Haemoglobin||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.||g/L||Standard Deviation|Mean
833174|NCT01265498|Secondary|Change in Triglycerides||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.||mmol/L||Standard Deviation|Mean
833175|NCT01265498|Secondary|Change in LDL Cholesterol||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.||mmol/L||Standard Deviation|Mean
833176|NCT01265498|Secondary|Change in HDL Cholesterol||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.||mmol/L||Standard Deviation|Mean
833177|NCT01265498|Secondary|Change in Total Cholesterol||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.||mmol/L||Standard Deviation|Mean
833178|NCT01265498|Secondary|Change in Total Bilirubin||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.||μmol/L||Standard Deviation|Mean
833179|NCT01265498|Secondary|Change in γ-glutamyl Transpeptidase||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.||U/L||Standard Deviation|Mean
834044|NCT01263509|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 12).|The change between the value of fasting plasma glucose collected at week 12 and fasting plasma glucose collected at baseline.|Baseline and Week 12.|Values are Summary Statistics.||mg/dL||Standard Deviation|Mean
833180|NCT01265498|Secondary|Change in Alkaline Phosphatase||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.||U/L||Standard Deviation|Mean
833181|NCT01265498|Secondary|Change in Asparate Aminotransferase||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.||U/L||Standard Deviation|Mean
833182|NCT01265498|Secondary|Change in Alanine Aminotransferase||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.||U/L||Standard Deviation|Mean
833183|NCT01265498|Secondary|Portal Inflammation: Change in Score|Change in portal inflammation score. Portal inflammation was assessed on a scale of 0-3, with higher scores showing more severe portal inflammation.|baseline to 72 weeks|Number of patients with biopsy specimens at baseline and 72 weeks||units on a scale||Standard Deviation|Mean
833184|NCT01265498|Secondary|Portal Inflammation: Patients With Improvement|Patients with improvement in portal inflammation score. Portal inflammation was assessed on a scale of 0–2, with higher scores showing more severe portal inflammation.|baseline to 72 weeks|Number of patients with biopsy specimens at baseline and 72 weeks||participants|||Number
833185|NCT01265498|Secondary|Lobular Inflammation: Change in Score|Change in lobular inflammation score. Lobular inflammation was assessed on a scale of 0-3, with higher scores showing more severe lobular inflammation.|baseline to 72 weeks|Number of patients with biopsy specimens at baseline and 72 weeks||units on a scale||Standard Deviation|Mean
833186|NCT01265498|Secondary|Lobular Inflammation: Patients With Improvement|Patients with improvement in lobular inflammation score. Lobular inflammation was assessed on a scale of 0–3, with higher scores showing more severe lobular inflammation.|baseline to 72 weeks|Number of patients with biopsy specimens at baseline and 72 weeks||participants|||Number
833187|NCT01265498|Secondary|Steatosis: Change in Score|Change in steatosis score. Steatosis was assessed on a scale of 0-3, with higher scores showing more severe steatosis.|baseline to 72 weeks|Number of patients with biopsy specimens at baseline and 72 weeks||units on a scale||Standard Deviation|Mean
833188|NCT01265498|Secondary|Steatosis: Patients With Improvement|Patients with improvement in steatosis score. Steatosis was assessed on a scale of 0–3, with higher scores showing more severe steatosis.|baseline to 72 weeks|Number of patients with biopsy specimens at baseline and 72 weeks||participants|||Number
833189|NCT01265498|Secondary|Hepatocellular Ballooning: Change in Score|Change in hepatocellular ballooning score. Hepatocellular ballooning was assessed on a scale of 0-2, with higher scores showing more severe ballooning.|baseline to 72 weeks|Number of patients with biopsy specimens at baseline and 72 weeks||units on a scale||Standard Deviation|Mean
833190|NCT01265498|Secondary|Hepatocellular Ballooning: Patients With Improvement|Patients with improvement in hepatocellular ballooning score. Hepatocellular ballooning was assessed on a scale of 0–2, with higher scores showing more severe ballooning.|baseline to 72 weeks|Number of patients with biopsy specimens at baseline and 72 weeks||participants|||Number
833191|NCT01265498|Secondary|Total NAFLD Activity Score: Change in Score|NAFLD activity score was assessed on a scale of 0–8, with higher scores showing more severe disease (the components of this measure are steatosis [assessed on a scale of 0–3], lobular inflammation [assessed on a scale of 0–3], and hepatocellular ballooning [assessed on a scale of 0–2]).|baseline to 72 weeks|Number of patients with biopsy specimens at baseline and 72 weeks||units on a scale||Standard Deviation|Mean
833192|NCT01265498|Secondary|Fibrosis: Change in Score|Change in fibrosis score. Fibrosis was assessed on a scale of 0–4, with higher scores showing more severe fibrosis.|baseline to 72 weeks|||units on a scale||Standard Deviation|Mean
833193|NCT01265498|Secondary|Fibrosis: Patient With Improvement|Patients with improvement in fibrosis score. Fibrosis was assessed on a scale of 0–4, with higher scores showing more severe fibrosis.|baseline to 72 weeks|Number of patients with biopsy specimens at baseline and 72 weeks||participants|||Number
833194|NCT01265498|Secondary|Resolution of NASH Diagnosis|Resolution of definite nonalcoholic steatohepatitis. Resolution defined as either not NAFLD, or NAFLD but not non-alcoholic steatohepatitis on week 72 biopsy|baseline to 72 weeks|Number of patients with biopsy specimens at baseline and 72 weeks||participants|||Number
833195|NCT01265498|Primary|Hepatic Histological Improvement in Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS)|"Centrally scored histological improvement in nonalcoholic fatty liver disease (NAFLD) from baseline to the end of 72 weeks of treatment, where improvement is defined as:
No worsening in fibrosis; and
A decrease in NAFLD Activity Score (NAS) of at least 2 points"|baseline to 72 weeks|Number of randomly assigned patients with observed or expected week 72 visit before protocol modified on Jan 6, 2014, to eliminate week 72 biopsy. 11 patients in the placebo group and eight in the obeticholic acid group had missing histological data at week 72, and the results for these patients were imputed as a lack of improvement.||participants|||Number
833196|NCT01265511|Secondary|Undetectable HCV RNA||Week 24|Week 24 analysis does not include the 2 placebo subjects because they were discontinued for lack of efficacy before week 24.||participants|||Number
833197|NCT01265511|Secondary|Partial Early Virologic Response|Proportion of subjects with detectable HCV RNA that achieve a > or = 2 log reduction in HCV RNA from baseline to Week 12|Week 12|||participants|||Number
833198|NCT01265511|Secondary|Undetectable HCV RNA||Week 12|||participants|||Number
833199|NCT01265511|Primary|Undetectable HCV RNA||Week 4|||participants|||Number
833200|NCT01265524|Secondary|6MWT Distance at Week 8|Increase in the 6 minute walk test (6MWT) distance from baseline to Week 8. The test was performed according to the American Thoracic Society (ATS)Guidelines 2002.|Baseline and 8 weeks|The efficacy and the safety analyses were done using the ITT population with Week 8/EOS data for the patients who did not complete the 8-week treatment period excluded. The ITT population included all randomized patients who received at least 1 dose of study drug.||m||Standard Deviation|Mean
834045|NCT01263509|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 8).|The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline.|Baseline and Week 8.|Values are Summary Statistics.||mg/dL||Standard Deviation|Mean
833201|NCT01265524|Secondary|Number of Patients Improving by at Least One NYHA Functional Class From Baseline to Week 8||Baseline and 8 weeks|The efficacy and the safety analyses were done using the ITT population with Week 8/EOS data for the patients who did not complete the 8-week treatment period excluded. The ITT population included all randomized patients who received at least 1 dose of study drug.||participants|||Number
833202|NCT01265524|Secondary|Frequency of Marked or Disabling Exertional Dyspnea by Physician Assessment at Week 8|The frequency of marked or disabling exertional dyspnea was physician assessed based on physical exam at week 8.|8 weeks|||participants|||Number
833203|NCT01265524|Secondary|Frequency of Marked or Disabling Exertional Dyspnea by Physician Assessment at Week 4|The frequency of marked or disabling exertional dyspnea was physician assessed based on physical exam at week 4.|4 weeks|||participants|||Number
833204|NCT01265524|Secondary|Weight Loss at Week 2||Baseline and 2 weeks|The efficacy and the safety analyses were done using the ITT population with Week 8/EOS data for the patients who did not complete the 8-week treatment period excluded. The ITT population included all randomized patients who received at least 1 dose of study drug.||kg||Standard Deviation|Mean
833205|NCT01265524|Secondary|Weight Loss at Week 1||Baseline and 1 week|The efficacy and the safety analyses were done using the ITT population with Week 8/EOS data for the patients who did not complete the 8-week treatment period excluded. The ITT population included all randomized patients who received at least 1 dose of study drug.||kg||Standard Deviation|Mean
833206|NCT01265524|Primary|Change in Serum Potassium|Change in serum potassium from baseline to Week 8.|Baseline and 8 weeks|The efficacy and the safety analyses were done using the ITT population with Week 8/EOS data for the patients who did not complete the 8-week treatment period excluded. The ITT population included all randomized patients who received at least 1 dose of study drug.||mg/dl||Standard Deviation|Mean
833207|NCT01265563|Secondary|Urinary Alpha-1 Microglobulin, Inflammatory Cytokines and C-C Chemokines|Urinary alpha-1 microglobulin, inflammatory cytokines and C-C chemokines were never measured and analysed.|Baseline and 3 months||||||
833208|NCT01265563|Secondary|Change From Baseline in Hemoglobin-A1c|Hemoglobin A1C was assessed at the end of the run in period and after 3 months of administration of study interventions. Here is delta HgA1C is reported between the two periods|Baseline and 3 months|||percentage||Standard Deviation|Mean
833209|NCT01265563|Primary|Change From Baseline in Urinary Albumin Excretion|Urine albumin to creatinine ratio was assessed at the end of run in period and after 3 months administration of study intervention.|Baseline and 3 months|||mg/g||Standard Deviation|Mean
833210|NCT01265615|Secondary|Coronary Calcium Score|Bone mineral density assessed by dual-energy X-ray absorptiometry (DXA) of the whole body, lumbar spine and hip was performed using Hologic scanners (QDR 1000W or QDR 2000). The total Agatston coronary calcium score (CCS) was measured as the sum of calcified plaque scores of all the coronary arteries. The amount of calcium present in the coronary arteries is scored according to the Agatson scale, as follows: 0 - no identifiable disease; 1 to 99 - mild disease; 100 to 399 - moderate disease; 400 or higher - severe disease.|on day 180|||units on a scale||Standard Deviation|Mean
833211|NCT01265615|Secondary|Systolic Blood Pressure|SBP measured by routine method|on day 180|||mmHg||Standard Deviation|Mean
833212|NCT01265615|Secondary|VDR (Vitamin D Receptor) Expression in Kidney|VDR content was determined by using an ELISA developed in this laboratory. The protein concentration of the homogenates was determined by the method of Bradford (1976), using BSA as a standard.|on day 180|||fmol VDR/ mg protein||Standard Deviation|Mean
833213|NCT01265615|Secondary|VDR (Vitamin D Receptor) Expression in Myocardium|VDR content was determined by using an ELISA developed in this laboratory. The protein concentration of the homogenates was determined by the method of Bradford (1976), using BSA as a standard.|on day 180|||fmol VDR/ mg protein||Standard Deviation|Mean
833214|NCT01265615|Secondary|Number of Circulating SP (Side Population) Stem-Progenitor Cells|Renal cells and solid tissue were obtained from the normal portion of cortex obtained from surgically removed kidneys or by standart biopsy on day 180. Cytofluorimetric analysis and immunofluorescence were performed as described by Oliver J.A. (2004). Sorting and analysis of different cells was done on a FACS (fluorescent activated cell sorting) and by flow cytometry. Cells were analyzed with EPICS systems (Beckman Coulter). Quantification of mRNA expression was achieved using Assays-on-Demand gene expression kits and the ABI PRISM 7000 Sequence Detection System (Applied Biosystem).|on day 180|||per cent of SP cells||Standard Deviation|Mean
833215|NCT01265615|Secondary|Serum Creatinine|After an overnight fast, plasma concentrations of hemoglobin, creatinine, cholesterol, glucose, total calcium, and phosphate were measured using an autoanalyzer as described by Adorini L. (2005)|on day 180 after Tx|||mg/dL||Standard Deviation|Mean
833216|NCT01265615|Secondary|CAD (Chronic Allograft Dysfunction) Degree|"CAD degree measured by Banff score after routine renal biopsy (revised 2005/2007 criteria). We assessed antibody-mediated rejection, borderline changes, T-cell-mediated rejection, interstitial fibrosis and tubular atropthy, and other changes. Grades:
Grade I. Mild interstitial fibrosis and tubular atrophy (<25% of cortical area) II. Moderate (26–50%) III. Severe (>50%) (may include non-specific vascular and glomerular sclerosis)"|on day 90|||Scores on a Banff scale||Standard Deviation|Mean
833217|NCT01265615|Secondary|GFR (Glomerular Filtration Rate)|Estimated glomerular filtration rate (eGFR) was calculated using the abbreviated form of the Modification of Diet in Renal Disease (MDRD) study equation: eGFR = exp (5.228 − 1.154 × ln (serum creatinine) − 0.203 × ln (age). Concerning of GFR with Tc99m DTPA renography was used for the complex analysis of renal function. Camera based GFR estimated from Tc99m DTPA renography was named Gates GFR.|on day 180|||ml/min/1.73 m^2||Standard Deviation|Mean
833218|NCT01265615|Secondary|Heart Failure (HF)|"NYHA (New York Heart Association) functional class verified with veloergometry probe and by NYHA clinical classification NYHA Class Symptoms I No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc.
II Mild symptoms and slight limitation during ordinary activity. III Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20–100 m).
Comfortable only at rest. IV Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients."|on day 180 after Tx (transplantation)|A total of 120 patients (Russian and dutch caucasian, kidney recipients with vitamin D deficiency defined as 25(OH)D < 40 nmol/l) were assigned. Analysis was per protocol.||NYHA functional class of HF||Standard Deviation|Mean
833219|NCT01265615|Primary|CAD (Chronic Allograft Dysfunction) Degree|"Beyond 180 days, chronic allograft dysfunction (CAD) was characterized by mean Banff degree (revised 2005/2007 criteria) with the data of renal biopsy material. Renal tissue was recovered during routined biopsy. We assessed antibody-mediated rejection, borderline changes, T-cell-mediated rejection, interstitial fibrosis and tubular atropthy, and other changes. Grades:
Grade I. Mild interstitial fibrosis and tubular atrophy (<25% of cortical area) II. Moderate (26–50%) III. Severe (>50%) (may include non-specific vascular and glomerular sclerosis)"|day 180 after Tx (transplantation)|||Scores on a Banff scale||Standard Deviation|Mean
833220|NCT01265667|Secondary|Nature and Frequency of Adverse Events|Assessment of safety of CF101 in this patient population by gathering adverse event data based on history, vital signs, physical examination, and laboratory data|32 weeks|||Participants|||Count of Participants
833221|NCT01265667|Secondary|Numberof Patients Achieving Psoriasis Area and Severity (PASI) Score of 50 or 75|Achievement of PASI 50 or 75 indicates a 50% and 75% reduction respectively in the PASI score, which ranges from 0 (no disease) to 72 (maximal disease)|16 weeks|Analysis performed of the ITT population||participants|||Number
833222|NCT01265667|Secondary|Number of Subjects Achieving PGA of 0 or 1|PGA is a physician's assessment of the severity of disease based on a 6-point scale (score of 0 = clear and 5 = very severe)|16 weeks|Analysis was performed on the ITT population||participants|||Number
833223|NCT01265667|Primary|Number of Subjects Achieving Psoriasis Area and Severity Index (PASI) 75 at 12 Weeks|Achievement of PASI 75 indicates a 75% reduction in the PASI score, which ranges from 0 (no disease) to 72 (maximal disease)|12 weeks|Analysis was performed on the Intent-to-treat (ITT) Population||Participants|||Count of Participants
833224|NCT01265784|Secondary|Pharmacokinetics: Area Under the Concentration Time Curve From Time 0 to 12 Hours (AUC[0-12]) of TP-434||Prior to first infusion and 1, 3, 7, 12, 48, and 108 hours after start of first infusion|All randomized participants without significant protocol deviations who received at least 1 dose of TP-434 and had evaluable AUC(0-12) data.||nanogram*hours per milliliter (ng*h/mL)||Standard Deviation|Mean
833225|NCT01265784|Secondary|Pharmacokinetics: Maximum Concentration (Cmax) of TP-434||Prior to first infusion and 1, 3, 7, 12, 48, and 108 hours after start of first infusion|All randomized participants without significant protocol deviations who received at least 1 dose of TP-434 and had evaluable Cmax data.||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
833226|NCT01265784|Secondary|Microbiologic Response to TP-434 and Ertapenem in the ME Population at the TOC Visit||TOC Visit (10-14 days after last dose of study drug)|All randomized participants who received at least 1 dose of study drug, met the minimal disease definition of cIAI, had a baseline pathogen identified, and had a microbiological response assessed.||participants|||Number
833227|NCT01265784|Secondary|Microbiologic Response to TP-434 and Ertapenem in the ME Population at the EOT Visit||EOT Visit (4-14 days after first dose of study drug)|All randomized participants who received at least 1 dose of study drug, met the minimal disease definition of cIAI, had a baseline pathogen identified, and had a microbiological response assessed.||participants|||Number
833228|NCT01265784|Secondary|Microbiologic Response to TP-434 and Ertapenem in the m-MITT Population at the TOC Visit||TOC Visit (10-14 days after last dose of study drug)|All randomized participants who received at least 1 dose of study drug, met the minimal disease definition of cIAI, and had a baseline pathogen identified. The minimal disease definition of cIAI included IAI that extended beyond the hollow viscus of origin into the peritoneal space and was associated with either abscess formation or peritonitis.||participants|||Number
833229|NCT01265784|Secondary|Microbiologic Response to TP-434 and Ertapenem in the m-MITT Population at the EOT Visit|Microbiological response was classified as favorable (eradication or presumed eradication), unfavorable (persistence, presumed persistence, superinfection, or new infection), or indeterminate (assessment not possible).|EOT Visit (4-14 days after first dose of study drug)|All randomized participants who received at least 1 dose of study drug, met the minimal disease definition of cIAI, and had a baseline pathogen identified. The minimal disease definition of cIAI included IAI that extended beyond the hollow viscus of origin into the peritoneal space and was associated with either abscess formation or peritonitis.||participants|||Number
833230|NCT01265784|Secondary|Clinical Response to TP-434 and Ertapenem in the Microbiologically Evaluable (ME) Population at the Follow-up Visit||Follow-up Visit (28-42 days after last dose of study drug)|All randomized participants who received at least 1 dose of study drug, met the minimal disease definition of cIAI, had a baseline pathogen identified, and had a microbiological response assessed.||participants|||Number
833231|NCT01265784|Secondary|Clinical Response to TP-434 and Ertapenem in the Microbiologically Evaluable (ME) Population at the EOT Visit||EOT Visit (4-14 days after first dose of study drug)|All randomized participants who received at least 1 dose of study drug, met the minimal disease definition of cIAI, had a baseline pathogen identified, and had a microbiological response assessed.||participants|||Number
833232|NCT01265784|Secondary|Clinical Response to TP-434 and Ertapenem in the Clinically Evaluable (CE) Population at the Follow-up Visit||Follow-up Visit (28-42 days after last dose of study drug)|All randomized participants who received at least 1 dose of study drug, met the minimal disease definition of cIAI, and for whom sufficient information was available to determine the participant’s outcome with no confounding factors present that interfered with the assessment of that outcome.||participants|||Number
833233|NCT01265784|Secondary|Clinical Response to TP-434 and Ertapenem in the Clinically Evaluable (CE) Population at the TOC Visit||TOC Visit (10-14 days after last dose of study drug)|All randomized participants who received at least 1 dose of study drug, met the minimal disease definition of cIAI, and for whom sufficient information was available to determine the participant’s outcome with no confounding factors present that interfered with the assessment of that outcome.||participants|||Number
833234|NCT01265784|Secondary|Clinical Response to TP-434 and Ertapenem in the Clinically Evaluable (CE) Population at the EOT Visit||EOT Visit (4-14 days after first dose of study drug)|All randomized participants who received at least 1 dose of study drug, met the minimal disease definition of cIAI, and for whom sufficient information was available to determine the participant’s outcome with no confounding factors present that interfered with the assessment of that outcome.||participants|||Number
834130|NCT01269918|Primary|Hemodynamics|Hemodynamics were defined as mean arterial pressure (MAP), measured in milimeters of mercury (mmHg). This outcome was analyzed using a repeated measures ANOVA approach. In the outcome measure data table, mean ± standard deviation MAP was reported as the aggregate mean across time points.|15, 30, 45, 60, and 90 minutes after extubation.|||mmHg||Standard Deviation|Mean
833235|NCT01265784|Secondary|Clinical Response to TP-434 and Ertapenem in the Microbiologically Modified Intent-to-treat (m-MITT) Population at the Follow-up Visit||Follow-Up Visit (28-42 days after last dose of study drug)|All randomized participants who received at least 1 dose of study drug, met the minimal disease definition of cIAI, and had a baseline pathogen identified. The minimal disease definition of cIAI included IAI that extended beyond the hollow viscus of origin into the peritoneal space and was associated with either abscess formation or peritonitis.||participants|||Number
833236|NCT01265784|Secondary|Clinical Response to TP-434 and Ertapenem in the Microbiologically Modified Intent-to-treat (m-MITT) Population at the TOC Visit||TOC Visit (10-14 days after last dose of study drug)|All randomized participants who received at least 1 dose of study drug, met the minimal disease definition of cIAI, and had a baseline pathogen identified. The minimal disease definition of cIAI included IAI that extended beyond the hollow viscus of origin into the peritoneal space and was associated with either abscess formation or peritonitis.||participants|||Number
833237|NCT01265784|Secondary|Clinical Response to TP-434 and Ertapenem in the Microbiologically Modified Intent-to-treat (m-MITT) Population at the EOT Visit||EOT Visit (4-14 days after first dose of study drug)|All randomized participants who received at least 1 dose of study drug, met the minimal disease definition of cIAI, and had a baseline pathogen identified. The minimal disease definition of cIAI included IAI that extended beyond the hollow viscus of origin into the peritoneal space and was associated with either abscess formation or peritonitis.||participants|||Number
833238|NCT01265784|Secondary|Clinical Response to TP-434 and Ertapenem in the Clinically Modified Intent-to-treat (c-MITT) Population at the Follow-up Visit||Follow-up Visit (28-42 days after last dose of study drug)|All randomized participants who received at least 1 dose of study drug and met the minimal disease definition of IAI. The minimal disease definition included all IAI, whether complicated or not. Identification of a baseline pathogen was not required for this population.||participants|||Number
833239|NCT01265784|Secondary|Clinical Response to TP-434 and Ertapenem in the Clinically Modified Intent-to-treat (c-MITT) Population at the TOC Visit||TOC Visit (10-14 days after last dose of study drug)|All randomized participants who received at least 1 dose of study drug and met the minimal disease definition of IAI. The minimal disease definition included all IAI, whether complicated or not. Identification of a baseline pathogen was not required for this population.||participants|||Number
833240|NCT01265784|Secondary|Clinical Response to TP-434 and Ertapenem in the Clinically Modified Intent-to-treat (c-MITT) Population at the EOT Visit||EOT Visit (4-14 days after first dose of study drug)|All randomized participants who received at least 1 dose of study drug and met the minimal disease definition of intra-abdominal infection (IAI). The minimal disease definition included all IAI, whether complicated or not. Identification of a baseline pathogen was not required for this population.||participants|||Number
833241|NCT01265784|Secondary|Clinical Response to TP-434 and Ertapenem in the Modified Intent-to-treat (MITT) Population at the Follow-up Visit||Follow-up Visit (28-42 days after last dose of study drug)|All randomized participants who received at least 1 dose of study drug.||participants|||Number
833242|NCT01265784|Secondary|Clinical Response to TP-434 and Ertapenem in the Modified Intent-to-treat (MITT) Population at TOC Visit||TOC Visit (10-14 days after last dose of study drug)|All randomized participants who received at least 1 dose of study drug.||participants|||Number
833243|NCT01265784|Secondary|Clinical Response to TP-434 and Ertapenem in the Modified Intent-to-treat (MITT) Population at the End-of-Treatment (EOT) Visit||EOT Visit (4-14 days after first dose of study drug)|All randomized participants who received at least 1 dose of study drug.||participants|||Number
833244|NCT01265784|Primary|Clinical Response to TP-434 and Ertapenem in the Microbiologically Evaluable (ME) Population at the Test-of-Cure Visit|Clinical response was classified as cure (complete resolution or significant improvement of signs and symptoms of the index infection), failure (death related to complicated intra-abdominal infection [cIAI], persisting or recurrent infection within the abdomen, postsurgical wound infection, or administration of effective concomitant antibacterial therapy), or indeterminate (Test-of-Cure [TOC] assessment was not available, death unrelated to cIAI, or some other reason).|TOC Visit (10-14 days after last dose of study drug)|All randomized participants who received at least 1 dose of study drug, met the minimal disease definition of cIAI, had a baseline pathogen identified, and had a microbiological response assessed.||participants|||Number
833245|NCT01265797|Secondary|Epworth Sleepiness Scale Score|"Mean difference of Epworth Sleepiness Scale score between run-in month and open label month. The Epworth Sleepiness Scale is used to measure excessive daytime sleepiness. This is an 8 item questionnaire, recalling probability of falling asleep in recent times. The subjects are asked to rate probability of falling asleep in eight different situations. The score for each item ranges from 0 (would never doze) to 3 (high chance of dozing), with the overall score range of 0 to 24. Higher scores represent higher probability of falling asleep."|Score recorded at the end of run-in and open label month|||score on a scale||95% Confidence Interval|Mean
833246|NCT01265797|Secondary|Epworth Sleepiness Scale Score|"Mean difference of Epworth Sleepiness Scale score between run-in month and blinded month. The Epworth Sleepiness Scale is used to measure excessive daytime sleepiness. This is an 8 item questionnaire, recalling probability of falling asleep in recent times. The subjects are asked to rate probability of falling asleep in eight different situations. The score for each item ranges from 0 (would never doze) to 3 (high chance of dozing), with the overall score range of 0 to 24. Higher scores represent higher probability of falling asleep."|recorded at the end of run-in month and blinded month|||score on a scale||95% Confidence Interval|Mean
833247|NCT01265797|Secondary|Somatic Symptom Score (Patient Health Questionnaire-15)|"Mean difference in PHQ 15 score between run-in month and open label month. The PHQ-15 comprises 15 somatic symptoms experienced over the prior 4 weeks and their severity, each symptom scored from 0 (not bothered at all) to 2 (bothered a lot). The range for the overall score is between 0 and 30, with higher score representing more severe somatic symptoms."|28 day period in run-in month and open label month|||score on a scale||95% Confidence Interval|Mean
833248|NCT01265797|Secondary|Somatic Symptom Severity (Patient Health Questionnaire 15)|"Mean difference in PHQ 15 score between run-in month and blinded month. The PHQ-15 comprises 15 somatic symptoms experienced over the prior 4 weeks and their severity, each symptom scored from 0 (not bothered at all) to 2 (bothered a lot). The range for the overall score is between 0 and 30, with higher score representing more severe somatic symptoms"|28 days recall; measured at end of run-in month and blinded month|||score on a scale||95% Confidence Interval|Mean
833249|NCT01265797|Secondary|Generalized Anxiety Disorder Score (GAD 7)|Mean difference in GAD 7 score between run-in month and open label month. This is a screening tool and severity measure for generalized anxiety disorder addressing symptoms over the prior 2 weeks. It is a 7 item questionnaire with response scores for each item ranging from 0 (not at all) to 3 (every day). The range for the total score is 0 to 21, with higher scores representing greater symptoms of anxiety|14 day recall, recorded at the end of run-in and open label months|||score on a scale||95% Confidence Interval|Mean
833250|NCT01265797|Secondary|Generalized Anxiety Disorder Score (GAD 7)|Mean difference in GAD 7 score between run-in month and blinded month. This is a screening tool and severity measure for generalized anxiety disorder addressing symptoms over the prior 2 weeks. It is a 7 item questionnaire with response scores for each item ranging from 0 (not at all) to 3 (every day). The range for the total score is 0 to 21, with higher scores representing greater symptoms of anxiety|14 days recall; measured at end of run-in month and blinded month|||score on a scale||95% Confidence Interval|Mean
833251|NCT01265797|Secondary|Headache Impact Test (HIT-6) (Measure of Disability Due to Headaches)|Mean difference in HIT-6 score between run-in month and open label month. The HIT-6 is a tool for screening and monitoring change in headache disability. This disease-specific health survey is intended for adults 18 years of age and older, and is available with a standard four-week recall period. It is a 6 item questionnaire with scores for each item ranging from 6 (never) to 13 (always). The minimum overall score is 36 and the maximum is 78. Higher scores represent greater disability.|28 day period in run-in month and open label month|||score on a scale||95% Confidence Interval|Mean
833252|NCT01265797|Secondary|Headache Impact Test-6|Mean difference in HIT-6 score between run-in month and blinded month. The HIT-6 is a tool for screening and monitoring change in headache disability. This disease-specific health survey is intended for adults 18 years of age and older, and is available with a standard four-week recall period. It is a 6 item questionnaire with scores for each item ranging from 6 (never) to 13 (always). The minimum overall score is 36 and the maximum is 78. Higher scores represent greater disability.|after run-in month, after blinded month|||score on a scale||95% Confidence Interval|Mean
833253|NCT01265797|Primary|Depression Score (PATIENT HEALTH QUESTIONNAIRE [PHQ] 9)|Mean difference of PHQ-9 score between the run-in month and blinded month, i.e. PHQ-9 score from run-in month minus blinded month. The PHQ-9 is a tool for assisting in diagnosing depression (over the prior 2 week period) as well as selecting and monitoring treatment. There are nine items, with responses each ranging from 0 (not at all) to 3 (nearly every day), for a total range of 0 to 27. The higher the total the more severe the depressive symptoms.|14 days recall; measured at end of run-in month and blinded month|The number of participants included the individuals who have completed the run-in period and the blinded period. The data was analyzed 'per protocol' based on the number of participants completing the blinded period.||depression score/14 day recall||95% Confidence Interval|Mean
833254|NCT01265797|Secondary|Depression Score (Patient Health Questionnaire-9)|Mean difference of PHQ-9 score between the run-in month and open label month, i.e. PHQ-9 score from run-in month minus open label month. The PHQ-9 is a tool for assisting in diagnosing depression (over the prior 2 week period) as well as selecting and monitoring treatment. There are nine items, with responses each ranging from 0 (not at all) to 3 (nearly every day), for a total range of 0 to 27. The higher the total the more severe the depressive symptoms.|14 day recall, recorded at the end of run-in and open label months|||score on a scale||95% Confidence Interval|Mean
833255|NCT01265797|Secondary|Headache Days|Mean change in headache days between 28 day run-in month and 28 day open label month, i.e. run-in month mean minus open label month mean. A good response is >= 50% reduction in headache days (congruent with the Guidelines for Trial of Behavioral Treatments for Recurrent Headache).|28 day period in run-in month and open label month|||headache days/ 28 day period||95% Confidence Interval|Mean
833256|NCT01265797|Primary|Mean Headache Days|Mean change in headache days between 28 day run-in month and 28 day blinded month, i.e. run-in month mean minus blinded month mean. A good response is >= 50% reduction in headache days (congruent with the Guidelines for Trial of Behavioral Treatments for Recurrent Headache).|28 day period during run-in month and blinded month|||headache days/ 28 day period||95% Confidence Interval|Mean
833257|NCT01265823|Secondary|Serum Levels of Vitamin B12 at Baseline and Week 16|Normal values for vitamin B12 were 200-1100 pg/mL.|Baseline, Week 16|Participants with available data at given time points.||pg/mL||Standard Deviation|Mean
833258|NCT01265823|Secondary|Serum Levels of Vitamin B6 at Baseline and Week 16|Normal values for vitamin B6 were 18-175 nmol/L.|Baseline, Week 16|Participants with available data at given time points.||nmol/L||Standard Deviation|Mean
833259|NCT01265823|Secondary|Serum Levels of Folic Acid at Baseline and Week 16|Normal values for folic acid were 3-15 ng/mL.|Baseline, Week 16|Participants with available data at given time point.||ng/mL||Standard Deviation|Mean
833260|NCT01265823|Secondary|Serum Levels of Vitamin B12 at Baseline and Week 4|Normal values for vitamin B12 were 200-1100 pg/mL.|Baseline, Week 4|Participants with available data at given time points.||pg/mL||Standard Deviation|Mean
833261|NCT01265823|Secondary|Serum Levels of Vitamin B6 at Baseline and Week 4|Normal values for vitamin B6 were 18-175 nmol/L.|Baseline, Week 4|Participants with available data at given time points.||nmol/L||Standard Deviation|Mean
833262|NCT01265823|Secondary|Serum Levels of Folic Acid at Baseline and Week 4|Normal values for folic acid were 3-15 ng/mL.|Baseline, Week 4|Participants with available data at given time points.||ng/mL||Standard Deviation|Mean
833263|NCT01265823|Secondary|Percentage of Obese vs. Non-obese (Per Waist-Hip Ratio) Participants Achieving a Psoriasis Area and Severity Index (PASI)-75 Response and a Total Dermatology Life Quality Index (DLQI) Score of <6 at Week 16|The Waist-Hip Ratio was used to determine the groups of participants who were overweight and who were considered obese. Obesity was defined as a ratio of >1 for men and >0.8 for women. Response to treatment in participants with obesity (based on Waist-Hip Ratio) versus those without obesity was assessed via PASI-75 response (see Outcome Measure 1 for details) and DLQI score of <6 (see Outcome Measure 3 for details).|Week 16|ITT population||percentage of participants|||Number
833314|NCT01266070|Primary|Most Frequent & Most Serious Adverse Events: Safety of Dovitinib for 6 Months|Most frequent & Most Serious Adverse Events: Safety of treatment with Dovitinib for 6 months in participants with VHL who have a measurable hemangioblastoma undergoing surveillance evaluated by toxicity scored using Common Toxicity Criteria (CTC) Version 4.0.|Every 2 cycles (approximately 8 weeks) for 6 months|||Participants|||Count of Participants
833264|NCT01265823|Secondary|Percentage of Obese vs. Non-obese (Per Body Mass Index [BMI]) Participants Achieving a Psoriasis Area and Severity Index (PASI)-75 Response and a Total Dermatology Life Quality Index (DLQI) Score of <6 at Week 16|The Body Mass Index (BMI) was used to determine the groups of participants who were overweight and who were considered obese. A BMI of 18.5 to 25 was considered normal range, 25 to 30 as overweight and 30 and above as obesity, in both men and women. Response to treatment in participants with obesity (based on Body Mass Index) versus those without obesity was assessed via PASI-75 response (see Outcome Measure 1 for details) and DLQI score of <6 (see Outcome Measure 3 for details).|Week 16|ITT Population||percentage of participants|||Number
833265|NCT01265823|Secondary|Mean Homocysteine Levels at Baseline and Week 16|Normal values for homocysteine were 5-13.9 µmol/L.|Baseline, Week 16|Participants with available data at given time points.||µmol/L||Standard Deviation|Mean
833266|NCT01265823|Secondary|Mean Lipid Profile, Triglycerides, and C-Reactive Protein (CRP) at Baseline and Week 16|Normal values: C-reactive protein (CRP) 0-0.79 mg/dL; cholesterol 30-199 mg/dL; high density lipoprotein (HDL) 40-100 mg/dL; very low density lipoprotein (VLDL) 0-34 mg/dL; low density lipoprotein (LDL) 20-99 mg/dL; triglycerides 50-149 mg/dL.|Baseline, Week 16|Participants with available data at given time points.||mg/dL||Standard Deviation|Mean
833267|NCT01265823|Secondary|Physician’s Global Assessment (PGA) at Week 16|The PGA is a 7-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant. Categories are as follows: Severe = very marked plaque elevation, scaling, and/or erythema; Moderate to severe = marked plaque elevation, scaling, and/or erythema; Moderate = moderate plaque elevation, scaling, and/or erythema; Mild to moderate = intermediate between moderate and mild; Mild = slight plaque elevation, scaling, and/or erythema; Almost clear = intermediate between mild and clear; Clear = no signs of psoriasis (post-inflammatory hypopigmentation or hyperpigmentation could be present). The number of participants who achieve a PGA of 'clear' or 'almost clear' at Week 16 was a secondary outcome measure in this study.|Week 16|ITT population. Participants with missing scores were considered nonresponders.||participants|||Number
833268|NCT01265823|Secondary|Physician's Global Assessment (PGA) at Week 4|The PGA is a 7-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant. Categories are as follows: Severe = very marked plaque elevation, scaling, and/or erythema; Moderate to severe = marked plaque elevation, scaling, and/or erythema; Moderate = moderate plaque elevation, scaling, and/or erythema; Mild to moderate = intermediate between moderate and mild; Mild = slight plaque elevation, scaling, and/or erythema; Almost clear = intermediate between mild and clear; Clear = no signs of psoriasis (post-inflammatory hypopigmentation or hyperpigmentation could be present).|Week 4|ITT population. Participants with missing scores were considered nonresponders.||participants|||Number
833269|NCT01265823|Secondary|Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI)-50, 90, 100 Responses at Week 16|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI-50, 90, and 100 responses are the percentage of participants who achieved at least a 50%, 90%, or 100% reduction (improvement) from baseline in PASI score at Week 4. 100% reduction was considered complete clearance of psoriasis.|Week 16|ITT population. Participants with missing scores were considered nonresponders.||percentage of participants|||Number
833270|NCT01265823|Secondary|Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI)-50, 90, 100 Responses at Week 4|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI-50, 90, and 100 responses are the percentage of participants who achieved at least a 50%, 90%, or 100% reduction (improvement) from baseline in PASI score at Week 4. 100% reduction was considered complete clearance of psoriasis.|Week 4|ITT population. Participants with missing scores were considered nonresponders.||percentage of participants|||Number
833271|NCT01265823|Secondary|Dermatology Life Quality Index (DLQI) Categories at Week 16|Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. The following scoring categories present the effect on participant’s life: 0-1 no effect at all; 2-5 small effect; 6-10 moderate effect; 11-20 very large effect; 21-30 extremely large effect.|Week 16|ITT population. Participants with missing scores were considered nonresponders.||participants|||Number
833272|NCT01265823|Secondary|Dermatology Life Quality Index (DLQI) Categories at Week 4|Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. The following scoring categories present the effect on participant’s life: 0-1 no effect at all; 2-5 small effect; 6-10 moderate effect; 11-20 very large effect; 21-30 extremely large effect.|Week 4|ITT population. Participants with missing scores were considered nonresponders.||participants|||Number
833273|NCT01265823|Secondary|Mean Score of Dermatology Life Quality Index (DLQI) at Baseline and Week 16|Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired.|Baseline, Week 16|Participants with evaluable data at given time points.||units on a scale||Standard Deviation|Mean
833315|NCT01266122|Secondary|Changes in Psychosocial Mediators|We will examine the degree to which hypothesized mediators change differentially across the experimental and control arms.|up to 6 months||||||
833316|NCT01266122|Secondary|Acquisition of STIs - Number of Participants That Acquired STIs|We will test for locally relevant STIs at baseline and 6 months.|6 months|||participants|||Number
833274|NCT01265823|Secondary|Mean Score of Dermatology Life Quality Index (DLQI) at Baseline and Week 4|Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired.|Baseline, Week 4|Participants with evaluable data at given time points.||units on a scale||Standard Deviation|Mean
833275|NCT01265823|Primary|Percentage of Participants With a Dermatology Life Quality Index (DLQI) Score < 6 at Week 16|Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. A score <6 indicates that psoriasis has small or no effect at all on participant's life.|Week 16|Intention-to-treat (ITT) population. Participants with missing scores were considered nonresponders.||percentage of participants|||Number
833276|NCT01265823|Primary|Percentage of Participants With a Dermatology Life Quality Index (DLQI) Score < 6 at Week 4|Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. A score <6 indicates that psoriasis has small or no effect at all on participant’s life.|Week 4|Intention-to-treat (ITT) population. Participants with missing scores were considered nonresponders.||percentage of participants|||Number
833277|NCT01265823|Primary|Percentage of Participants With Psoriasis Area and Severity Index (PASI)-75 Response at Week 16|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy.|Week 16|Intention-to-treat (ITT) population. Participants with missing scores were considered nonresponders.||percentage of participants|||Number
833278|NCT01265823|Primary|Percentage of Participants With Psoriasis Area and Severity Index (PASI)-75 Response at Week 4|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 4. The improvement in PASI score was used as a measure of efficacy.|Week 4|Intention-to-treat (ITT) population. Participants with missing scores were considered nonresponders.||percentage of participants|||Number
833279|NCT01265875|Secondary|VAS Score at Each Administered Dose.|10 point scare from 0-10 with higher scores meaning higher levels of pain. VAS score assessed after each dose was summarized over Days 1, 2, and 3.|Days 1, 2, and 3.|||units on a scale||Standard Deviation|Mean
833280|NCT01265875|Primary|Quality of Life at Baseline, Day 4 and Day 30.|Sf-36 ranges from 0 to 151. Higher scores indicating worse outcomes.|Baseline, Day 4, Day 30.|||units on a scale||Standard Deviation|Mean
833281|NCT01265875|Primary|Opiate Use at Baseline, Days 4 and 30.|Daily opiate use (oral morphine equivalent).|Baseline, Day 4, Day 30.|||mg/day||Standard Deviation|Mean
833282|NCT01265875|Secondary|Number of Participants With Serious Adverse Events.||30 Days|||participants|||Number
833283|NCT01265875|Primary|VAS Score at Baseline, Days 1, 2, 3, 4, 7, 30.|10 point visual analog scale. 0= no pain. 10= worst possible pain. Days 1, 2, 3 were infusion days that included 5 VAS scores each day.|Baseline, Days 1, 2, 3, 4, 7, 30.|||units on a scale||Standard Deviation|Mean
833284|NCT01265953|Primary|Expression of Histone Deacetylase 6 (HDAC6)|Immunohistochemical (IHC) analysis of HDAC6 expression using research-only prostate biopsy tissue collected post-intervention at the time of the clinically-indicated prostate biopsy. A modified Histo-score (H-score) was calculated, which involved semiquantitative assessment of both staining intensity (graded as 1-3 with 1 representing weak staining, 2 moderate, and 3 strong) and percentage of positive cells. H-score ranged from 0 to 300 with 300 the strongest expression.|minimum 4 to maximum 8 weeks; prostate biopsy were collected post-intervention when clinically-indicated|||H-score||Standard Error|Mean
833285|NCT01265953|Primary|Expression of Ki67|Ki67 is a biomarker of disease progression. Immunohistochemical (IHC) analysis of Ki67 was performed using research only prostate biopsy specimens collected post-intervention at the time of the clinically-indicated prostate biopsy.|minimum 4 to maximum 8 weeks; prostate biopsy were collected post-intervention when clinically-indicated|Some subjects did not have post-intervention prostate tissue that can be used for IHC analysis, therefore, the overall number of participants analyzed for IHC analysis is different from the total enrolled subjects.||% of positivity||Standard Error|Mean
833286|NCT01265953|Primary|Change of Total Plasma SFN (Sulforaphane) Metabolites Level|In subjects at risk for prostate cancer, presence of SFN was analyzed in plasma. Collection of blood specimens occurred at pre-intervention and post-intervention. The Change = post-intervention level minus pre-intervention level|minimum 4 to maximum 8 weeks|We missed blood samples from some subjects, therefore, total number of subjects analyzed for the plasma-based analysis is different from the number of total enrolled subjects.||micromolar (µM)||Standard Error|Mean
833287|NCT01265953|Primary|Change of Total Urine SFN (Sulforaphane) Metabolites|Collection of blood and urine specimens occurred at pre-intervention and post-intervention. Change = post-intervention level minus pre-intervention level|minimum 4 to maximum 8 weeks|Not all subjects had urine samples for analysis, therefore, the total number of subjects in this urine analysis is different from total number of enrolled subjects.||micromolar (µM) concentrations of urina||Standard Error|Mean
833317|NCT01266122|Primary|Changes in HIV Risk Taking Behavior - Number of Condomless Sex Acts Per Participant|We will examine sexual risk taking among the sample using self-report (interviewer administered) measures.|up to 6 months|||number of unprotected sex acts||Standard Deviation|Mean
833288|NCT01265966|Primary|Change From Baseline to Peak Salivary Cortisol Level|Salivary cortisol will be measured prior to the sedated procedure before any intravenous lines or other stress occurs, and then every 30 minutes into the sedated procedure while the patient is being routinely suctioned. Salivary cortisol will also be measured at the end of the procedure and 30 minutes post procedure (recovery). Because many different types of procedures are performed (imaging, endoscopy, surgical) the end times of the procedures will vary for each patient. The investigators will calculate a relative change from baseline for salivary cortisol levels by comparing the peak to baseline recorded level.|Baseline, then every 30 minutes, and at end of procedure|All patients with adequate samples for analysis.||Number (ratio of peak to baseline)||Standard Error|Mean
833289|NCT01265992|Secondary|Number of Participants Using Concomitant Medications at Baseline||Baseline|Full analysis set||participants|||Number
833290|NCT01265992|Secondary|Total Indirect Costs of Care Associated With Secondary Hyperparathyroidism|"Indirect costs were estimated by using the number of hours missed from work (absenteeism) multiplied by the average hourly labor cost, including wages and benefits, to calculate average lost productivity costs due to absenteeism during the preceding 7 days.
Hours missed from work were assessed using the Work Productivity and Activity Impairment Questionnaire: General Health (WPAI-GH) questionnaire, in which respondents answer 6 questions related to work productivity and impairment.
Unit costs were taken from official sources (Statistics Sweden, www.scb.se) and published literature."|6 months|Participants who were working for pay and with available data at both time points.||Swedish krona per participant||Standard Deviation|Mean
833291|NCT01265992|Secondary|Total Direct Costs of Care Associated With Secondary Hyperparathyroidism|Direct medical costs to be calculated included outpatient visits, hospitalizations, pharmaceuticals, etc. However the data collected in this observational study was not enough to support this calculation.|6 months||||||
833292|NCT01265992|Secondary|Change From Baseline in Quality of Life Assessed by the Kidney Disease Quality of Life-Short Form (KDQOL-SF)|"The KDQOL-SF is a self-report measure developed for individuals with kidney disease. It includes 43 end-stage renal disease (ESRD)-targeted items focused on particular areas of concern for individuals with kidney disease (Symptoms/problems, Effects of the disease on daily life, Burden of disease, Work status, Cognitive function, Quality of social interaction, Sexual function, Sleep, and Social support), 36 items (SF-36) that provide 8 measures of physical and mental health (Physical functioning, Role limitations caused by physical health limitations, Role limitations caused by emotional health problems, Social functioning, Emotional well-being, Pain, Energy/fatigue and General health perceptions), and 1 overall health rating item where respondents rate their health on a scale from 0 (worst possible health) to 10 (best possible health).
Scores are transformed and calculated such that each scale score ranges from 0 to 100 where higher scores reflect a better quality of life."|Baseline and 6 months|Per-protocol analysis set with available data at both time points.||units on a scale||Standard Deviation|Mean
833293|NCT01265992|Secondary|Percentage of Participants With a Reduction of Proteinuria of at Least 15% From Baseline||Baseline and 6 months|Per-protocol analysis set. Percentages are based on the total number of participants in the per-protocol analysis set.||percentage of participants|||Number
833294|NCT01265992|Secondary|Change From Baseline in Proteinuria|Proteinuria is the presence of excess serum proteins, or albumin, in the urine. Proteinuria was measured by the amount of albumin per liter of urine.|Baseline and Month 6|Per-protocol analysis set with available data at both time points.||g/L||Standard Deviation|Mean
833295|NCT01265992|Primary|Percentage of Participants With Elevated Serum-Calcium (s-Ca) Levels at Baseline and 6 Months|Elevated serum calcium is defined according to the 2003 Kidney Disease Outcomes Quality Initiative (K/DOQI) target definitions of s-Ca above 2.37 mmol/L.|Baseline and 6 months|Per-protocol analysis set. One participant had missing s-Ca data at Baseline and one participant had missing s-Ca data at month 6; percentages are based on the total number of participants in the per-protocol analysis set (40).||percentage of participants|||Number
833296|NCT01265992|Primary|Percentage of Participants With Elevated Serum-Phosphorus (s-P) Levels at Baseline and 6 Months|"Elevated serum phosphorus is defined according to the 2003 Kidney Disease Outcomes Quality Initiative (K/DOQI) target definitions as:
Stage 3 CKD: ≥ 1.49 mmol/L;
Stage 4 CKD: ≥ 1.49 mmol/L;
Stage 5 CKD: > 1.78 mmol/L."|Baseline and 6 months|Per-protocol analysis set. Two patients had missing s-P data at month 6; percentages are based on the total number of participants in the per-protocol analysis set (40).||percentage of participants|||Number
833297|NCT01265992|Primary|Percentage of Participants With Intact Parathyroid Hormone Within K/DOQI Target Range at Baseline and 6 Months|"Kidney Disease Outcomes Quality Initiative (K/DOQI) target intact parathyroid hormone (iPTH) levels are:
Stage 3 CKD (estimated Glomerular Filtration Rate* [eGFR] 30 – 59 mL/min): 3.85 – 7.7 pmol/L;
Stage 4 CKD (eGFR 15 – 29 mL/min): 7.7 – 12.1 pmol/L;
Stage 5 CKD (eGFR < 15 mL/min): 16.5 – 33 pmol/L.
*Calculated using the Modification of Diet in Renal Disease formula."|Baseline and 6 months|Per-protocol analysis set. Three participants had missing data at Baseline and one participant had missing data at the 6 month visit; percentages are based on the total number of participants in the per-protocol analysis set (40).||percentage of participants|||Number
833298|NCT01265992|Primary|Change From Baseline in Intact Parathyroid Hormone at 6 Months||Baseline and 6 months|Per-Protocol Analysis Set (PPAS), defined as all included participants who received at least 1 dose of paricalcitol capsules and had analyzable data for the primary endpoints, i.e., 5 - 8 months after inclusion, and with available iPTH data at both time points.||pmol/L||Standard Deviation|Mean
833299|NCT01266018|Secondary|Assessment of Overall Survival|Overall survival was measured from the initial date of treatment to the recorded date of death. Because the study was terminated prematurely, no statistical analyses of overall survival data were performed.|Every 4 weeks for up to 16 months|Subjects who had survival status recorded during post-study follow-up.||Participants|||Count of Participants
833300|NCT01266018|Secondary|Assessment of Immunogenicity of ADI-PEG 20|Blood samples were collected for all subjects at enrollment, prior to each treatment, and at the end of study to evaluate changes in ADI-PEG 20 antibody titer in peripheral blood over time. Disease state (ie, relapsed sensitive vs refractory) was not considered relevant to this analysis and as such samples were collected without regard for cohort assignment.|Every 1 to 4 weeks for up to 16 weeks|The Pharmacodynamic Analysis Set comprises all subjects who received at least 1 dose of study drug and provided plasma samples for pharmacodynamic analyses. A total of 121 plasma samples from 21 subjects were analyzed. Summary data are presented through Day 58, i.e., the last time point with at least 3 samples available for calculation of a mean.||log 10 IU/mL||Full Range|Mean
833301|NCT01266018|Secondary|Assessment of Pharmacodynamics of ADI-PEG 20|Blood samples were collected from all subjects at enrollment, prior to each treatment, and at the end of study to evaluate changes in plasma arginine and citrulline levels following administration of ADI-PEG 20. Disease state (ie, relapsed sensitive vs refractory) was not considered relevant to this analysis and as such samples were collected without regard for cohort assignment.|Every 1 to 4 weeks for up to 16 weeks|The Pharmacodynamic Analysis Set comprises all subjects who received at least 1 dose of study drug and provided plasma samples for pharmacodynamic analyses. A total of 121 plasma samples from 21 subjects were analyzed. Summary data are presented through Day 58, i.e., the last time point with at least 3 samples available for calculation of a mean.||uM||Full Range|Mean
833302|NCT01266018|Secondary|Assessment of Safety of Arginine Deiminase Pegylated (ADI-PEG) 20|Analysis of treatment-emergent adverse events (TEAEs) reported from clinical laboratory tests, physical examinations, and vital signs.|Every 1 to 4 weeks for up to 16 weeks|The Safety Analysis Set comprises all subjects who received at least 1 dose of study drug.||participants|||Number
833303|NCT01266018|Primary|Best Overall Response|"Tumor responses were evaluated using any appropriate imaging type and were categorized according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Per RECIST for target lesions and assessed by MRI:
Complete Response (CR): Disappearance of all target lesions [no evidence of disease]; Partial Response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria."|Every 4 to 8 weeks for up to 16 weeks|Includes all patients who were evaluable for tumor response allocation.||participants|||Number
833304|NCT01266031|Secondary|Radiological Response|Magnetic resonance imaging (MRI) and contrast-enhanced (CE) MRI was used to evaluate tumor response. Response is defined by the Modified MacDonald criteria. Complete Response (CR) is complete disappearance of all measurable and evaluable disease. Partial response (PR) is greater than or equal to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. Partial Response, Non-Measurable (PRNM) is not applicable. Stable/No Response does not qualify for CR, PR or progression. Progression is 25% increase in the sum of products, of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any lesion/site, OR failure to return for evaluation due to health or deteriorating condition (unless clearly unrelated to this cancer).|End of therapy||01/2018||||
833305|NCT01266031|Secondary|Mean Symptom Interference at the Time of Clinical Evaluation|"Proportion of patients rating their symptoms to be 7 or greater on a 0-10 scale using the MD Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT) Self Reporting Tool. Zero is not present and 10 is as bad as you can imagine. All patients with at least one valid questionnaire will be included in the anlyses. Differences of at least 2 points will be classified as the minimum clinically meaningful change in the symptom severity and symptom interference measures."|Baseline, week 4, week 8, and end of therapy||01/2018||||
833306|NCT01266031|Secondary|Mean Core Symptom Severity Using the MD Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT) Self Reporting Tool|"Proportion of patients rating their symptoms to be 7 or greater on a 0-10 scale using the MD Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT) Self Reporting Tool. Zero is not present and 10 is as bad as you can imagine. All patients with at least one valid questionnaire will be included in the anlyses. Differences of at least 2 points will be classified as the minimum clinically meaningful change in the symptom severity and symptom interference measures."|Baseline, week 4, week 8, and end of therapy||01/2018||||
833307|NCT01266031|Secondary|Mean Severity of the MD Anderson Symptom Inventory-Brain Tumor Module (MDSAI-BT)|"Proportion of patients rating their symptoms to be 7 or greater on a 0-10 scale using the MD Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT) Self Reporting Tool. Zero is not present and 10 is as bad as you can imagine. All patients with at least one valid questionnaire will be included in the anlyses. Differences of at least 2 points will be classified as the minimum clinically meaningful change in the symptom severity and symptom interference measures."|Baseline, week 4, week 8, and end of therapy||01/2018||||
833308|NCT01266031|Secondary|Effects of Bevacizumab With and Without Vorinostat Upon Biomarkers of Angiogenesis|About 5cc of blood was collected to measure plasma angiogenic proteins vascular endothelial growth factor (VEGF), placental growth factor (PIGF), basic fibroblast growth factor (bFGF), stromal cell-derived factor α (SDF1α), angiopoietin 1 and 2 by enzyme-linked immunosorbent assay (ELISA).|Baseline before treatment, Cycle 1 Day 2, day 15 (pre-infusion and post-infusion), Cycle 2 (pre-infusion)||01/2018||||
833309|NCT01266031|Secondary|Overall Survival (OS)|Time between the first day of treatment to the day of death.|Time between the first day of treatment to the day of death.||01/2018||||
833310|NCT01266031|Secondary|Time to Progression (TTP)|Time between the first day of treatment to the day of disease progression.|Time between the first day of treatment to the day of disease progression.||01/2018||||
833311|NCT01266031|Primary|Maximum Tolerated Dose (MTD) of Oral Vorinostat Used With Bevacizumab|MTD defined as the dose level at which 1/6 patients experience dose limiting toxicity (DLT), using conventional Phase I design where the MTD was selected using a 3+3 accrual design at each dose level until MTD was determined. Toxicities will be graded according to the Common Terminology Criteria for Adverse events (CTCAE) Version 4.0.|28 day, cycle 1|||mg/day|||Number
833312|NCT01266031|Primary|Progression Free Survival (PFS) at 6 Months|"PFS is time measured in months to disease progression as assessed at six months from participant registration. Assessments continue every 8 weeks up to 28 days after last dose (follow-up), anticipated trial length one year.
Participants must be assessed at least 4 weeks after surgery to begin treatment in the adaptive randomized Phase 2 portion of the trial. PFS in participants in the surgical arm determined from the date of randomization to the treatment arms and not from the date of registration in the trial.
Study outcome measure period ended June 2015."|Baseline until disease progression or death due to any cause, up to six months|Of the 90 participants (Bev+V: 49, Bev: 41) enrolled, 83 were evaluable for the primary endpoint (Bev+V: 46, Bev: 37).||Months||95% Confidence Interval|Median
833313|NCT01266070|Secondary|Number of VHL Participants With Response at 6 Months|Efficacy of treatment with dovitinib for 6 months in patients with VHL who have a measurable lesion evaluated by response using RECIST (Response Evaluation Criteria in Solid Tumors): Complete Response, Partial Response, Progressive Disease or Stable Disease.|Every 2 cycles (approximately 8 weeks) for 6 months|||Participants|||Count of Participants
833318|NCT01266148|Secondary|Change in Quality of Life - Euro Quality of Life 5D (EQ-5D)|Change in Quality of Life was assessed via the EQ-5D questionnaire which consists of: EQ-5D-5L descriptive system and EQ Visual Analogue scale (EQ VAS). The EQ-5D-5L comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems). The patient indicates his/her health state by checking the most appropriate statement. This decision results in a 1-digit number expressing the level selected for that dimension. The digits for 5 dimensions are combined in a 5-digit number describing the respondent’s health state. The possible score is 1 to 5 where a lower number indicates improvement. The EQ VAS records the patient’s self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled ‘the best health you can imagine’ and ‘the worst health you can imagine’. The score is 0 to 100 where a higher score represents improvement.|Pre transplant and 52 weeks|The intent to treat population includes the full analysis set patients with available data and without any major protocol deviations or criteria causing exclusion and for which data was available for analysis. Patients were analyzed according to the treatment to which they were randomized.||Units on a scale||Standard Deviation|Mean
833319|NCT01266148|Secondary|Change in Quality of Life Assessed by SF-36 (Minnesota Living With Heart Failure Questionnaire ([MLHF)]) From Pre-transplant to Week 52 of Treatment|Change in Quality of Life was assessed via the SF-36 (Minnesota Living with Heart Failure questionnaire ([MLHF)]) before transplant surgery and at week 52 of treatment. The SF-36 is a validated, self-administered questionnaire. The questionnaire, which includes 36 questions measures 8 dimensions of health: physical function, role-physical, bodily pain, general health, vitality, social function, role-emotional, and mental health. Scores can be summarized in 2 summary components assessing physical and mental health. Items in each dimension are coded, aggregated, summed, and transformed into a scale ranging from 0 (worse health) to 100 (best health).|Pre transplant and 52 weeks|The intent to treat population includes the full analysis set patients with available data and without any major protocol deviations or criteria causing exclusion and for which data was available for analysis. Patients were analyzed according to the treatment to which they were randomized.||Units on a scale||Standard Deviation|Mean
833320|NCT01266148|Secondary|Lipid Profile at 12 Months|Total Cholesterol, LDL-Chol, HDL-Chol and TG at week 52. Measurements were taken via participants blood samples.|52 weeks|The safety sert include all randomized participants who received at least one dose of study medication and had blood samples taken at week 52.||mmol/L||Standard Deviation|Mean
833321|NCT01266148|Secondary|Average Level of Protenuria at Week 52|Proteinuria is measured as the ratio of albumin/creatinine mg/mmol. Measurements were taken from participants urine samples.|52 weeks|The safety sert include all randomized participants who received at least one dose of study medication and were able to provide urine samples at week 52.||mg/mmol||Standard Deviation|Mean
833322|NCT01266148|Secondary|Occurrence of Treatment Failures up to 12 Months After Transplant|Treatment failure was defined as the number of participants who died or lost their graft at any timepoint througout the duration of the study.|52 weeks|The intent to treat population includes the full analysis set patients with available data and without any major protocol deviations or criteria causing exclusion and for which data was available for analysis. Patients were analyzed according to the treatment to which they were randomized.||participants|||Number
833323|NCT01266148|Secondary|Number of Rejections Leading to Hemodynamic Compromise|Number of all rejections were recorded through the duration of the study with the intent to identify rejections leading to hemodynamic compromise.|52 weeks|The intent to treat population includes the full analysis set patients with available data and without any major protocol deviations or criteria causing exclusion and for which data was available for analysis. Patients were analyzed according to the treatment to which they were randomized.||rejections|||Number
833324|NCT01266148|Secondary|Calculated Glomerular Filtration Rate From Pre-Transplantation to Week 52|Calculated Glomerular Filtration Rate from pre-transplantation to week 52 was calculated according to the Modification of Diet in Renal Disease (MDRD) method. Measurements were taken prior to transplant (day 1), between weeks 7 to 11 and end of week 52.|Day 1, weeks 7 to 11 and of week 52|The intent to treat population includes the full analysis set patients with available data and without any major protocol deviations or criteria causing exclusion and for which data was available for analysis. Patients were analyzed according to the treatment to which they were randomized.||mGFR mL/min||Standard Deviation|Mean
833325|NCT01266148|Secondary|Change in Calculated Glomerular Filtration Rate From Pre-transplantation to Week 52|Change in calculated glomerular filtration rate from pre-transplantation to week 52 was calculated according to the Modification of Diet in Renal Disease (MDRD) method. Measurements were taken prior to transplant (day 1), between weeks 7 to 11 and end week 52.|Day 1, weeks 7 to 11(baseline) and of week 52|The intent to treat population includes the full analysis set patients with available data and without any major protocol deviations or criteria causing exclusion and for which data was available for analysis. Patients were analyzed according to the treatment to which they were randomized.||mGFR mL/min||Standard Deviation|Mean
833326|NCT01266148|Secondary|Progression of Chronic Allograft Vasculopathy (CAV) Based on Incidence of Chronic Allograft Vasculopathy (CAV) From Baseline to Week 52|the progression of chronic allograft vasculopathy (CAV) assessed by intravascular ultrasound (IVUS) examinations, measured the incidence of CAV (in percent of patients) at baseline and at week 52. Incidence of CAV represents percent of patients having a MIT (maximal intima thickness) > 0.5 mm.|Baseline and week 52|The intent to treat population includes the full analysis set patients with available data and without any major protocol deviations or criteria causing exclusion and for which data was available for analysis. Patients were analyzed according to the treatment to which they were randomized.||Percentage of patients|||Number
833327|NCT01266148|Secondary|Progression of Chronic Allograft Vasculopathy (CAV) Based on Maximal Intimal Thickness (MIT) From Baseline to Week 52|The progression of chronic allograft vasculopathy (CAV) was assessed by intravascular ultrasound (IVUS) examinations and measured Maximal Intimal Thickness (MIT)(in mm). A major coronary epicardial artery (preferentially the left-anterior descending coronary artery) was imaged, and the MIT parameters were recorded at baseline and at week 52.|Baseline and week 52|The intent to treat population includes the full analysis set patients with available data and without any major protocol deviations or criteria causing exclusion and for which data was available for analysis. Patients were analyzed according to the treatment to which they were randomized.||mm||Standard Deviation|Mean
833328|NCT01266148|Primary|Measured Glomerular Filtration Rate (mGFR), 12 Months After Heart Transplantation|Measured Glomerular Filtration Rate (mGFR) describes the flow rate of filtered fluid through the kidney. GFR is equal to the clearance rate when any solute is freely filtered and is neither reabsorbed nor secreted by the kidneys. The rate therefore measured is the quantity of the substance in the urine that originated from a calculable volume of blood. Participants’ urine was used for this assessment at week 52 after heart transplant.|Week 52|The intent to treat population includes the full analysis set patients with available data and without any major protocol deviations or criteria causing exclusion and for which data was available for analysis. Patients were analyzed according to the treatment to which they were randomized.||mGFR ml/min||Standard Deviation|Mean
833329|NCT01266265|Primary|Prevalence of Respiratory Tract-Related Adverse Events of Interest|Percentage of patients who experienced a respiratory tract-related adverse event (grouped by category of interest) during the study.|Follow-up every 3 months|||percentage of participants|||Number
833330|NCT01266291|Secondary|Number of Patients Who Become Seizure Free While Taking Sabril|"Seizure freedom
Responder rate (complex partial seizures only)"|Seizure freedom will be assessed for the two month treatment phase of the study (months 4 and 5)|One 30 year old female, Caucasian, non-Hispanic subject enrolled in the study. Due to adverse events, she did not complete the study, however, she completed all required follow-up.||Participants|||Count of Participants
833331|NCT01266291|Primary|Number of Participants Safely Tolerating Sabril|"Antiepileptic Drug (AED) levels in blood
Comprehensive panel (blood test)
Complete Blood Count with differential (blood test)
Visual field tests testing
Ophthalmology exam assessment
Frequency and severity of adverse events reported by subjects throughout their involvement with the study"|Outcome measures will be assessed at the initiation of Sabril (titration), and at three and five months after starting Sabril. After this time, the subjects will have completed the study.|One 30 year old female, Caucasian, non-Hispanic subject enrolled in the study. Due to adverse events, she did not complete the study, however, she completed all required follow-up.||Participants|||Count of Participants
833332|NCT01266447|Secondary|Duration of Objective Response|Duration of objective response is defined as the duration from the time measurement criteria is met for partial or complete response by RECIST 1.1, whichever is first recorded, until the first date the recurrent or progressive disease is objectively documented. Per Response Evaluation Criteria in Solid Tumors (RECIST) criteria Complete Response (CR), disappearance of all target and non-target lesions without evidence of new lesion; Partial Response (PR), at least 30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD with no unequivocal progression of non-target lesions and no evidence of new lesion. Complete or partial response requires confirmation at greater than or equal to 4 weeks from initial documentation.|Every other cycle for first 6 months; then every 3 months until disease progression confirmed; and at any other time if clinically indicated based on symptoms or signs suggestive of progressive disease.The average of study treatment time was 2.3 months.|Eligible and Treated Patients with objective response||Months||Full Range|Median
833333|NCT01266447|Secondary|Overall Survival|Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.|From study entry to death or last contact, up to 5 years of follow-up.|Eligible and Treated Patients||months||95% Confidence Interval|Median
833334|NCT01266447|Secondary|Progression-free Survival|Progression-free survival is the period of time from study entry to time of disease progression, death or date of last contact, whichever occurs first. Progression is defined as at least a 20% increase in the sum of the longest dimensions (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions, or global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or death due to disease without prior objective documentation of progression.|From study entry to disease progression, death or date of last contact, whichever occurs first, up to 5 years of follow-up.|Eligible and Treated Patients||months||95% Confidence Interval|Median
833335|NCT01266447|Primary|Adverse Events (Grade 3 or Higher) During Treatment Period|Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v4.0.|During treatment period and up to 30 days after stopping the study treatment.The average of study treatment time was 2.3 months.|Eligible and treated patients - No statistical analysis provided for adverse events (grade 3 or higher) during treatment period.||Participants|||Number
833336|NCT01266447|Primary|Number of Patients With Dose-limiting Toxicities (in Safety lead-in)|A dose-limiting toxicity (DLT) is assessed by NCI CTCAE v4, occurring during cycle 1 of therapy.: A dose-limiting toxicity (DLT) is defined as either hematologic or non-hematologic toxicity assessed by NCI CTCAE v4, occurring during cycle 1 of therapy, which cause any of the following: For hematologic toxicity - dose delay of greater than 2 weeks due to failure to recover counts, Treatment related febrile neutropenia, grade 4 neutropenia lasting >7 days, treatment related grade 4 thrombocytopenia or clinically significant bleeding with grade 3 thrombocytopenia. For non-hematologic toxicity; study treatment related grade 3 or 4 non-hematological toxicity (excluding anorexia, constipation, fatigue, hypersensitivity/allergic reaction to one of the study drugs, nausea & vomiting, and grade 3 dehydration), grade 4 nausea and vomiting for >48 hours despite maximum medical management, electrolyte imbalance of > or equal to grade 3 that can be replaced within 48 hours; any drug related death|Up to 21 days|The first 6 eligible and treated patients who completed the 1st cycle of study treatment or had a DLT prior to completing the first cycle of study treatment||participants|||Number
833337|NCT01266447|Primary|Tumor Response|Complete and Partial Tumor Response as Assessed by RECIST 1.1. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), Complete Response (CR), disappearance of all target and non-target lesions without evidence of new lesion; Partial Response (PR), at least 30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD with no unequivocal progression of non-target lesions and no evidence of new lesion. Complete or partial response requires confirmation at greater than or equal to 4 weeks from initial documentation.|Every other cycle for first 6 months; then every 3 months thereafter until disease progression confirmed; and at any other time if clinically indicted based on symptoms or physical signs suggestive of progressive disease. The average time was 2.3 months|Eligible and Treated Patients||percentage of participants||90% Confidence Interval|Number
833338|NCT01257204|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Who Died During Follow-up Period|AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not has a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.|From end of treatment period up to Week 48 (follow-up period)|All follow-up participants.||participants|||Number
833339|NCT01257204|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Treatment-related AEs and Who Died During Treatment Period|AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not has a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Treatment-related AE was defined as an AE that had certain, probable, possible, or unknown relationship to study drug. Mild (Grade 1): awareness of event but easily tolerated; Moderate (Grade 2): discomfort enough to cause some interference with usual activity; Severe (Grade 3): inability to carry out usual activity; Very severe (Grade 4): debilitating, significantly incapacitates participant despite symptomatic therapy. Only Grade 2-4 treatment-related AEs were reported.|Baseline (Day 1) up to 24 weeks (treatment period)|All treated participants.||participants|||Number
833340|NCT01257204|Primary|Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 24 (SVR24) for Hepatitis C Virus (HCV) Genotype 3|SVR24 was defined as undetectable HCV RNA (HCV RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at follow-up Week 24. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Follow-up Week 24|All treated participants with HCV genotype 3.||percentage of participants||80% Confidence Interval|Number
833341|NCT01257204|Secondary|Number of Participants With Virologic Failure for Hepatitis C Virus (HCV) Genotype 3|"Virologic failure was defined as:
Virologic breakthrough: confirmed >1 log10 increase in HCV RNA over nadir or confirmed RNA ≥lower limit of quantitation (LLOQ) after confirmed HCV RNA <LLOQ, target not detected (TND) while on treatment
<1 log10 decrease in HCV RNA from baseline at Week 4 of treatment
Failure to achieve early virologic response: <2 log10 decrease in HCV RNA from baseline and HCV RNA ≥LLOQ at Week 12 of treatment
HCV RNA ≥LLOQ or <LLOQ, target detected (TD) at the end of treatment (EOT) (including early discontinuation)
Relapse, defined as HCV RNA ≥LLOQ or <LLOQ, TD during follow-up, after HCV RNA <LLOQ, TND at EOT.
The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory."|Baseline up to Week 48|"All treated participants with HCV genotype 3. Here, n signifies the number of participants evaluable for the respective category."||participants|||Number
833342|NCT01257204|Secondary|Number of Participants With Virologic Failure for Hepatitis C Virus (HCV) Genotype 2|"Virologic failure was defined as:
Virologic breakthrough: confirmed >1 log10 increase in HCV RNA over nadir or confirmed RNA ≥lower limit of quantitation (LLOQ) after confirmed HCV RNA <LLOQ, target not detected (TND) while on treatment
<1 log10 decrease in HCV RNA from baseline at Week 4 of treatment
Failure to achieve early virologic response: <2 log10 decrease in HCV RNA from baseline and HCV RNA ≥LLOQ at Week 12 of treatment
HCV RNA ≥LLOQ or <LLOQ, target detected (TD) at the end of treatment (EOT) (including early discontinuation)
Relapse, defined as HCV RNA ≥LLOQ or <LLOQ, TD during follow-up, after HCV RNA <LLOQ, TND at EOT.
The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory."|Baseline up to Week 48|"All treated participants with HCV genotype 2. Here, n signifies the number of participants evaluable for the respective category."||participants|||Number
833343|NCT01257204|Secondary|Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 12 (SVR12) for Hepatitis C Virus (HCV) Genotype 3|SVR12 was defined as undetectable HCV RNA (HCV RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at follow-up Week 12. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Follow-up Week 12|All treated participants with HCV genotype 3.||percentage of participants||80% Confidence Interval|Number
833344|NCT01257204|Secondary|Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 12 (SVR12) for Hepatitis C Virus (HCV) Genotype 2|SVR12 was defined as undetectable HCV RNA (HCV RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at follow-up Week 12. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Follow-up Week 12|All treated participants with HCV genotype 2.||percentage of participants||80% Confidence Interval|Number
833345|NCT01257204|Secondary|Percentage of Participants Achieving Complete Early Virologic Response (cEVR) at Week 12 for Hepatitis C Virus (HCV) Genotype 3|cEVR was defined as undetectable HCV RNA (HCV RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at Week 12. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 12|All treated participants with HCV genotype 3.||percentage of participants||80% Confidence Interval|Number
833346|NCT01257204|Secondary|Percentage of Participants Achieving Complete Early Virologic Response (cEVR) at Week 12 for Hepatitis C Virus (HCV) Genotype 2|cEVR was defined as undetectable HCV RNA (HCV RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at Week 12. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 12|All treated participants with HCV genotype 2.||percentage of participants||80% Confidence Interval|Number
833347|NCT01257204|Secondary|Percentage of Participants Achieving Rapid Virologic Response (RVR) at Week 4 for Hepatitis C Virus (HCV) Genotype 3|RVR was defined as undetectable HCV RNA (HCV RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at Week 4. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 4|All treated participants with HCV genotype 3.||percentage of participants||80% Confidence Interval|Number
833348|NCT01257204|Secondary|Percentage of Participants Achieving Rapid Virologic Response (RVR) at Week 4 for Hepatitis C Virus (HCV) Genotype 2|RVR was defined as undetectable HCV RNA (HCV RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at Week 4. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 4|All treated participants with HCV genotype 2.||percentage of participants||80% Confidence Interval|Number
833349|NCT01257204|Primary|Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 24 (SVR24) for Hepatitis C Virus (HCV) Genotype 2|SVR24 was defined as undetectable HCV RNA (HCV RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at follow-up Week 24. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Follow-up Week 24|All treated participants with hepatitis C virus genotype 2.||percentage of participants||80% Confidence Interval|Number
833350|NCT01257217|Secondary|Patient Reported Outcomes at Month 3|The Visual Task Difficulty Assessment (VISTAS) questionnaire was completed by the subject to assess difficulty in completing everyday tasks that depend on good vision. Tasks were rated using a 1 to 5 point scale, where 1 = no difficulty; 2 = minor difficulty; 3 = moderate difficulty; 4 = major difficulty; 5 = cannot accomplish. Individual scores for each task were averaged to obtain the overall score for each vision type/function. Near vision was defined as less than 50 cm; intermediate vision as 50 cm to 1 m; extended intermediate vision as 90 cm to 4 m; and distant vision as more than 4 m.|Month 3 from second eye implantation|This analysis population includes all subjects who received IOLs without major deviations and/or surgical complications.||units on a scale||Standard Deviation|Mean
833351|NCT01257217|Secondary|Mean Radner Reading Speed|Reading performance was measured using the Radner Reading Chart with no correction (without) and with best distance corrective aids (with). Reading speed was measured in words per minute.|Month 3 from second eye implantation|This analysis population includes all subjects who received IOLs without major deviations and/or surgical complications.||wpm||Standard Deviation|Mean
833352|NCT01257217|Secondary|Mean Refractive Spherical Equivalent at Month 3|A manifest refraction (vision check) was performed using a 100% contrast ETDRS chart under well-lit conditions. Results were documented for sphere, cylinder and axis readings. The refractive spherical equivalent was calculated according to the formula: sphere + ½ cylinder power. Both eyes contributed to the mean.|Month 3 from second eye implantation|This analysis population includes all subjects who received IOLs without major deviations and/or surgical complications.||diopter||Standard Deviation|Mean
833353|NCT01257217|Secondary|Uncorrected Visual Acuity Across a Range of Distances at Month 3|VA was tested binocularly unaided across a range of distances under well-lit conditions using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.|Month 3 from second eye implantation|This analysis population includes all subjects who received IOLs without major deviations and/or surgical complications.||logMAR||Standard Deviation|Mean
833354|NCT01257217|Secondary|Best Corrected Visual Acuity (BCVA) Across a Range of Distances at Month 3|Visual acuity (VA) was tested binocularly (both eyes together) with correction in place if needed across a range of distances under well-lit conditions using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.|Month 3 from second eye implantation|This analysis population includes all subjects who received IOLs without major deviations and/or surgical complications.||logMAR||Standard Deviation|Mean
833355|NCT01257217|Primary|Mean Binocular Defocus VA at Month 3|Defocus VA (an indicator of the expected range of vision with a presbyopia-correcting IOL) was tested binocularly with the participant's best spectacle correction using a chart. Lenses of different spherical powers were placed in front of the eyes to produce varying levels of defocus. The VA at each spherical power was measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.|Month 3 from second eye implantation|This analysis population includes all subjects who received IOLs without major deviations and/or surgical complications.||logMAR||Standard Deviation|Mean
833356|NCT01257230|Secondary|Time to First Asthma Exacerbation During the 48 Week Treatment Period|The median time to first asthma exacerbation was not calculable, so the number of patients who experienced an asthma exacerbation are presented for the measured values.|Week 48|FAS||Participants|||Number
833357|NCT01257230|Secondary|Time to First Severe Asthma Exacerbation During the 48 Week Treatment Period|The median time to first severe asthma exacerbation was not calculable, so the number of patients who experienced a severe asthma exacerbation are presented for the measured values. A severe asthma exacerbation was defined as a subgroup of all asthma exacerbations that required treatment with systemic corticosteroid for at least 3 days.|48 weeks|FAS||Participants|||Number
833358|NCT01257230|Secondary|ACQ6 Responders|"Responder rates based on the ACQ6 after 24 weeks of treatment. Analysis was performed using the following categories and definitions: responder (change from trial baseline ≤-0.5), no change (-0.5 <change from trial baseline <0.5) and worsening (change from trial baseline ≥0.5)
The ACQ6 score is calculated as the mean of the responses to the first 6 questions of the ACQ. The ACQ is a scale containing 7 questions, each question has a 7-point scale which ranges from 0 to 6; a score of 0 corresponds to no impairment and a score of 6 corresponds to maximum impairment."|Week 24|FAS||percentage of participants|||Number
833359|NCT01257230|Secondary|Control of Asthma as Assessed by ACQ6|"Change from baseline in AQC6 score at week 24.
The ACQ6 score is calculated as the mean of the responses to the first 6 questions of the ACQ. The ACQ is a scale containing 7 questions, each question has a 7-point scale which ranges from 0 to 6; a score of 0 corresponds to no impairment and a score of 6 corresponds to maximum impairment.
The measured values presented are actually adjusted means."|Baseline and week 24|FAS||units on a scale||Standard Error|Mean
833360|NCT01257230|Secondary|ACQ Total Score Responders|"Responder rates based on the ACQ total score after 24 weeks of treatment. Analysis was performed using the following categories and definitions: responder (change from trial baseline ≤-0.5), no change (-0.5 <change from trial baseline <0.5) and worsening (change from trial baseline ≥0.5)
The ACQ is a scale containing 7 questions, each question has a 7-point scale which ranges from 0 to 6; a score of 0 corresponds to no impairment and a score of 6 corresponds to maximum impairment."|Week 24|FAS||percentage of participants|||Number
833361|NCT01257230|Secondary|Control of Asthma as Assessed by ACQ Total Score|"Change from baseline in Asthma Control Questionnaire (ACQ) total score measured at week 24.
The ACQ is a scale containing 7 questions, each question has a 7-point scale which ranges from 0 to 6; a score of 0 corresponds to no impairment and a score of 6 corresponds to maximum impairment. ACQ total score was calculated as the mean of the responses to all 7 questions.
The measured values presented are actually adjusted means."|Baseline and week 24|FAS||Units on a scale||Standard Error|Mean
833362|NCT01257230|Secondary|Use of PRN Rescue Medication During the Day|"Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used during the day (24 hour period) based on the weekly mean at week 24.
The measured values presented are actually adjusted means."|Baseline and week 24|FAS||Number of puffs of rescue medication||Standard Error|Mean
833363|NCT01257230|Secondary|Use of PRN Rescue Medication During the Night-time|"Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used during the night-time based on the weekly mean at week 24.
The measured values presented are actually adjusted means."|Baseline and week 24|FAS||Number of puffs of rescue medication||Standard Error|Mean
833364|NCT01257230|Secondary|Use of PRN Rescue Medication During the Daytime|"Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used during the daytime based on the weekly mean at week 24.
The measured values presented are actually adjusted means."|Baseline and Week 24|FAS||Number of puffs of rescue medication||Standard Error|Mean
833365|NCT01257230|Secondary|FEF25-75 Change From Baseline|"Change from baseline in mean forced expiratory flow between 25% and 75% of the FVC (FEF25-75%), also known as maximum mid-expiratory flow, at individual time points after 24 weeks of treatment.
The measured values presented are actually adjusted means."|Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 24 weeks|Full analysis set. Missing data at a visit was imputed by the available data from the patient at that visit, completely missing visits were handled by the statistical model.||Litres per second||Standard Error|Mean
833366|NCT01257230|Secondary|FVC AUC (0-3h) Change From Baseline|"Change from baseline of area under the curve (AUC) from 0 to 3 h for FVC (FVC AUC0–3h) after 24 weeks of treatment. The AUC was calculated by using the trapezoidal rule divided by the observation time (3h).
The measured values presented are actually adjusted means."|Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 24 weeks|Full analysis set. Missing data at a visit was imputed by the available data from the patient at that visit, completely missing visits were handled by the statistical model.||Litres||Standard Error|Mean
833367|NCT01257230|Secondary|FEV1 AUC (0-3h) Change From Baseline|"Change from baseline of area under the curve (AUC) from 0 to 3 h for FEV1 (FEV1 AUC 0–3h) after 24 weeks of treatment. The AUC was calculated by using the trapezoidal rule divided by the observation time (3h).
The measured values presented are actually adjusted means."|Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 24 weeks|Full analysis set. Missing data at a visit was imputed by the available data from the patient at that visit, completely missing visits were handled by the statistical model.||Litres||Standard Error|Mean
833368|NCT01257230|Secondary|Trough FVC Change From Baseline|"Change from baseline of Trough (pre-dose) forced vital capacity (FVC) measured 10 min before the administration of trial medication after 24 weeks of treatment.
The measured values presented are actually adjusted means.."|Baseline and 24 weeks|Full analysis set. Missing data at a visit was imputed by the available data from the patient at that visit, completely missing visits were handled by the statistical model.||Litres||Standard Error|Mean
833369|NCT01257230|Secondary|FVC peak0-3 Change From Baseline|"Change from baseline in Maximum forced vital capacity (FVC) measured within the first 3 h after administration of trial medication (FVC peak0–3h) after 24 weeks of treatment.
The measured values presented are actually adjusted means."|Baseline and 24 weeks|Full analysis set. Missing data at a visit was imputed by the available data from the patient at that visit, completely missing visits were handled by the statistical model.||Litres||Standard Error|Mean
833370|NCT01257230|Secondary|Trough FEV1 Change From Baseline|"Change from baseline in Trough (pre-dose) Forced expiratory volume in 1 second (FEV1) measured at week 24.
The measured values presented are actually adjusted means."|Baseline and 24 weeks|Full analysis set. Missing data at a visit was imputed by the available data from the patient at that visit, completely missing visits were handled by the statistical model.||Litres||Standard Error|Mean
833371|NCT01257230|Primary|FEV1 peak0-3 Change From Baseline|"Change from baseline in peak Forced expiratory volume in 1 second within the first 3 hours post dosing (FEV1 peak0-3) measured at week 24.
Note, the measured values presented are actually adjusted means."|Baseline and 24 weeks|Full analysis set (FAS) was the same as the treated set which included all randomised patients who were dispensed trial medication and received at least one documents dose of trial medication. Missing data at a visit was imputed by the available data from the patient at that visit, completely missing visits were handled by the statistical model.||Litres||Standard Error|Mean
833372|NCT01257347|Secondary|Percentage of Visits With Hypertension Regimen Simplification, Non-adherent in Week Prior to Outcome Visit or Over Entire Monitoring Period|This will be determined by abstracting data from the electronic medical record after the 1-month visit using a standardized instrument. An outcome assessor who is blinded to clinician and patient group assignment will assess whether, during the 1-month visit, the provider simplified the regimen by switching from a short-acting, multi-day dosing medication to a long-acting, once per day medication or switched two medication to a single combination pill. All prescribing and test ordering at the recruitment clinic is recorded in the electronic medical record.|1 month clinic visit|patient-provider visits||percentage of patient-clinician visits|||Number
833373|NCT01257347|Secondary|Percentage of Visits With Counseling Performed During 1-month Visit, Non-adherent in Week Prior to Outcome Visit or Over Entire Monitoring Period|This will be determined based on interviewing patients immediately after the 1-month visit using a standardized questionnaire. A research assistant who is blinded to group assignment will ask patients questions that assess whether clinicians counseled them about taking their blood pressure medications during that most recent visit. These questions are adapted from a validated questionnaire that assesses provider communication about blood pressure medications.|1 month clinic visit|||percentage of patient-clinician visits|||Number
833374|NCT01257347|Secondary|Percentage of Visits With Regimen Intensification During 1-month Visit, Adherent in Week Prior to Outcome Visit, Only|This will be determined based on abstracting information from the electronic medical record after the 1-month visit using a standardized instrument. An outcome assessor who is blinded to clinician and patient group assignment will assess whether, during the 1-month visit, the provider intensified the blood pressure regimen (added or increased dose of medications). All prescribing and test ordering at the recruitment clinic is recorded in the electronic medical record.|1 month clinic visit|||percentage of patient-clinician visits|||Number
833375|NCT01257347|Primary|Percentage of Visits With Appropriate Hypertension Management|This is assessed using an algorithm in which patients are categorized as adherent or non-adherent based on electronic monitoring. If patients are adherent (summary measure of adherence to blood pressure medications in the week prior to visit is ≥ 80%), then hypertension management is appropriate if clinicians intensify the hypertension regimen or order testing for secondary hypertension. If patients are non-adherent (summary measure of adherence < 80%), then hypertension management is appropriate if clinicians take action to increase adherence through counseling or regimen simplification.|1 month clinic visit|||percentage of patient-clinician visits|||Number
833376|NCT01257425|Secondary|Time to Castration [Tcast] - Testosterone Level Less Than 0.5 ng/mL|tcast is the number of days between day of first administration of the study drug and the day the testosterone level reaches the limit of castration defined as testosterone level less than 0.5 ng/mL for the first time. Analysis of tcast was based on the Kaplan-Meier estimator.|12 weeks|Analysed for intent-to-treat (ITT) population comprised of 103 patients (IM: 51 and SC: 52 patients).||days||95% Confidence Interval|Median
833377|NCT01257425|Secondary|Time to Castration [Tcast] - Testosterone Level Less Than or Equal to 0.5 ng/mL|tcast is the number of days between day of first administration of the study drug and the day the testosterone level reaches the limit of castration defined as testosterone level less than or equal to 0.5 ng/mL for the first time. Analysis of tcast was based on the Kaplan-Meier estimator.|12 weeks|Analysed for intent-to-treat (ITT) population comprised of 103 patients (IM: 51 and SC: 52 patients).||days||95% Confidence Interval|Median
833378|NCT01257425|Secondary|Maximum Concentration of Serum Testosterone [Cmax] - Log-transformed Data|Cmax was assessed as the maximum testosterone serum concentration between the first administration of the study drug and Day 169.|1, 3, 5, 8, 15, 22, 29, 57, 85, 87, 113, 141 and 169 days post-dose|Analysed for intent-to-treat (ITT) population comprised of 103 patients (IM: 51 and SC: 52 patients).||log(ng/mL)||Standard Deviation|Mean
833379|NCT01257425|Secondary|Maximum Concentration of Serum Testosterone [Cmax] - Raw Data|Cmax was assessed as the maximum testosterone serum concentration between the first administration of the study drug and Day 169.|1, 3, 5, 8, 15, 22, 29, 57, 85, 87, 113, 141 and 169 days post-dose|Analysed for intent-to-treat (ITT) population comprised of 103 patients (IM: 51 and SC: 52 patients).||ng/mL||Standard Deviation|Mean
833380|NCT01257425|Secondary|Area Under the Curve of Testosterone Serum Concentration Between D85 and D169 (AUC85-169d)|Area under the curve calculated from serum testosterone concentration taken at intervals between Day 85 and Day 169 after dosing. From the curve describing serum testosterone concentration levels (ng/mL) over time, the AUC was calculated using numerical integration methods. This value was log-transformed to more closely meet the assumption of the statistical method.|85, 87, 113, 141 and 169 days post-dose|95 patients (IM: 47 patients, SC: 48 patients) received a second injection of the study drug.||log(ng*day/mL)||Standard Deviation|Mean
833381|NCT01257425|Secondary|Area Under the Curve of Testosterone Serum Concentration Between D1 and D169 (AUC1-169d)|Area under the curve calculated from serum testosterone concentration taken at intervals between the first administration (Day 1) of the study drug and Day 169 after dosing. From the curve describing serum testosterone concentration levels (ng/mL) over time, the AUC was calculated using numerical integration methods. This value was log-transformed to more closely meet the assumption of the statistical method.|1, 3, 5, 8, 15, 22, 29, 57, 85, 87, 113, 141 and 169 days post-dose|||log(ng*day/mL)||Standard Deviation|Mean
833382|NCT01257425|Primary|Area Under the Curve of Testosterone Serum Concentration Between D1 and D85 (AUC1-85d).|Area under the curve (AUC) calculated from serum testosterone concentration taken at intervals between the first administration (Day 1) of the study drug and Day 85 after dosing. From the curve describing serum testosterone concentration levels (ng/mL) over time, the AUC was calculated using numerical integration methods. This value was log-transformed to more closely meet the assumption of the statistical method.|1, 3, 5, 8, 15, 22, 29, 57, 85 days post-dose|Analysed from ITT population.||log(ng*day/mL)||Standard Deviation|Mean
833383|NCT01257438|Secondary|Percentage of Participants With Primary Lesion Patency (PLP) That is Superior for FLUENCY® PLUS Endovascular Stent Graft (Following PTA) Over PTA Alone Through Six Months in the Treatment of In-stent Restenotic Lesions.|Primary Lesion Patency (PLP) is defined as the interval after the index intervention until the next re-intervention at the original treatment site or until the extremity is abandoned for permanent access. Freedom from re-intervention is the criteria for success.|6 months|||% of subjects with successful PLP||95% Confidence Interval|Number
833384|NCT01257438|Primary|Non-inferiority of FLUENCY® PLUS Endovascular Stent Graft (Following PTA) Over PTA Alone Through 30 Days in the Treatment of In-stent Restenotic Lesions.|Safety rates measured for the randomized subjects population (both Arteriovenous (AV) Graft and Fistula subjects combined), the percentage of subjects free from safety events through 30 days.|30 days|Safety rates measured for the randomized subjects population (both AV Graft and Fistula subjects combined), the percentage of subjects free from safety events through 30 days.||% of subjects free from safety events||95% Confidence Interval|Number
833434|NCT01258049|Secondary|Early Treatment Failure|"Early treatment failure is indicated by one or more of the following:
Parasite count on Day 2 > Day 0, irrespective of temperature
Parasite count on Day 3 > 0 with tympanic temperature ≥ 38.0°C
Parasite count on Day 3 ≥ 25% of baseline
Administration of rescue antimalarial treatment"|Three days after the start of treatment|||participants|||Number
833385|NCT01257438|Primary|Percentage of Participants With Access Circuit Primary Patency (ACPP) That is Superior for FLUENCY® PLUS Endovascular Stent Graft (Following Percutaneous Transluminal Angioplasty (PTA)) Over PTA Alone Through Six Months.|Access Circuit Primary Patency (ACPP) is defined as the interval following the index intervention until the next access thrombosis or repeated intervention. ACPP ends with a reintervention anywhere within the access circuit, from the arterial inflow to the superior vena cava-right atrial junction. Venous rupture caused by PTA is not an ACPP failure unless achieving hemostasis also causes thrombosis. Freedom from access thrombosis or repeated intervention is the criteria for success.|6 months|Subjects at risk (at 6 months) is a calculation in Kaplan-Meier time-to-event analyses that refers to subjects who have not had ACPP failure through the 6 months (i.e., are event-free through 6 months).||% of subjects with successful ACPP||95% Confidence Interval|Number
833386|NCT01257503|Secondary|Overall Symptom Severity|Change in cold symptoms of child during the 7-10 days after the index visit for an upper respiratory tract infection. Parents assessed severity of runny nose, cough, sneeze and congestion in their child using a 0-3 scale for each symptom, 0=none to 3= severe. Cold score is sum of scores for each symptom. Parents assessed cold score twice daily on study days 1-3 and at the 7-10 day follow-up|10 days|Data analyzed on participant who completed 7-10 day follow-up and had valid cold scores. Data also analyzed twice daily on those participants who returned symptom diaries including: day 1 (153, 148), day 2 (146,138), and day 3 (136, 126). For category title, first n= homeopathic cold remedy, second n= placebo.||units on a scale||Standard Deviation|Mean
833387|NCT01257503|Secondary|Health Status|Change in health status of child during the 7-10 days after the index visit for an upper respiratory tract infection. Parents rated health status on 1-10 scale with 1 indicating perfect health and 10 indicating very sick. Health status rated on first 3 days of study and again at the 7-10 day follow-up|10 days|Health status on those with follow-up data and a valid score for health status. Health status also assessed in participants who returned symptom diaries including 152 on day 1, 142 on day 2 and 132 on day 3. For category title, first n= homeopathic cold remedy, second n= placebo.||units on a scale||Standard Deviation|Mean
833388|NCT01257503|Secondary|Functional Status|Change in functional status of child during the 7-10 days after the index visit for an upper respiratory tract infection. Parents rated 5 activities (vigorous activity, activities that require concentration, activities with family or friends, appetite and sleep) daily for 3 days in their child and again at the 7-10 day follow-up. Functional status scores range from 0 to 15, with higher scores indicative of better functional status.|10 days|Participants who completed follow-up and had valid data for functional outcome. Data on functional status analyzed on days 1-3 for participants who returned symptom diaries including 145 on day 1, 142 on day 2 and 130 on day 3. For category title, first n= homeopathic cold remedy, second n= placebo.||units on a scale||Standard Deviation|Mean
833389|NCT01257503|Secondary|Change in Non-specific Symptoms|Parents measured change in severity of irritability, lethargy, fussiness, and appetite one hour after administering a dose of study medication up to the first 10 doses of study medication. Change in symptom rated from 0 to 6, with 0 indicative of the symptom being much worse and 6 indicative of the symptom being much improved. The unit of analysis for each outcome was doses of medication. Each participant could contribute data on 0 - 10 doses.|Parents assessed change in symptom 1 hour after dose of study medication|Data are from logbooks returned by participants. For each participant, data on response to up to 10 doses were collected. Not every symptom was present at each dose. Change in irritability assessed after 510 doses, lethargy 414, fussiness 501, appetite 618. For category title, first n= homeopathic cold remedy, second n= placebo.||units on a scale|Participants|Standard Deviation|Mean
833390|NCT01257503|Primary|Change in Severity of Cold Symptoms|Parents measured change in runny nose, cough, nasal congestion and sneezing severity one hour after administering a dose of study medication up to the first 10 doses of study medication. Change in symptom rated from 0 to 6, with 0 indicative of the symptom being much worse and 6 indicative of the symptom being much improved. The unit of analysis for each outcome was doses of medication. Each participant could contribute data on 0 - 10 doses.|Parents assessed change in symptom 1 hour after a dose of study medication|Data are from logbooks returned by participants. For each participant, data on response to up to 10 doses were collected. Not every symptom was present at each dose. Change in runny nose assessed after 819 doses, sneeze 456 doses, cough 772 doses, congestion 845. For category title, first n= homeopathic cold remedy, second n= placebo.||units on a scale|Participants|Standard Deviation|Mean
833435|NCT01258049|Secondary|Complete Cure Rate|The complete resolution of clinical signs and symptoms, malaria-related laboratory abnormalities, and elimination of asexual parasites by Day 7, with no recurrence up to Day 28 (+/- 2 days), and the 48h parasite count to be < 25% of baseline with no clinical deterioration|28 days after the start of treatment|For some subjects, this endpoint was not evaluable and/or not all data was received.||participants|||Number
833398|NCT01257581|Secondary|ATLIS Upper Percentage of Predicted Normal (PPN)|The ATLIS PPN measures are percentages of predicted normal strength based on age, gender, height, and weight using normative data.|38 weeks of treatment followed by a telephone interview at 42 weeks.|||percentages of predicted normal strength||95% Confidence Interval|Mean
833399|NCT01257581|Secondary|Accurate Test of Limb Isometric Strength (ATLIS) Lower Percentage of Predicted Normal (PPN)|The ATLIS PPN measures are percentages of predicted normal strength based on age, gender, height, and weight using normative data.|38 weeks of treatment followed by a telephone interview at 42 weeks.|||percentages of predicted normal strength||95% Confidence Interval|Mean
833400|NCT01257581|Secondary|HHD Upper % Baseline|The HHD % baseline measures are mean percent change for shoulder flexion, elbow extension, elbow flexion, wrist extension, and first dorsal interosseous muscles from each participant's baseline.|38 weeks of treatment followed by a telephone interview at 42 weeks.|||percent change||95% Confidence Interval|Mean
833401|NCT01257581|Secondary|HHD Upper Z-score|The HHD upper z-scores are means of z-scores for right and left shoulder flexion, elbow extension, elbow flexion, write extension and first dorsal interosseous muscles with z-scores calculated relative to the baseline mean and standard deviation strength of each muscle group across all participants.|38 weeks of treatment followed by a telephone interview at 42 weeks.|||Z-score||95% Confidence Interval|Mean
833402|NCT01257581|Secondary|HHD Lower % Baseline|HHD % baseline measures are mean percent change for right and left knee extension, knee flexion, hip flexion, and ankle dorsiflexion from each participant's baseline.|38 weeks of treatment followed by a telephone interview at 42 weeks.|||percent change||95% Confidence Interval|Mean
833403|NCT01257581|Secondary|Hand Held Dynamometry (HHD) Lower Z-score|The HHD lower z-scores are means of z-scores for right and left knee extension, knee flexion, hip flexion, and ankle dorsiflexion with z-scores calculated relative to the baseline mean and standard deviation strength of each muscle group across all participants.|38 weeks of treatment followed by a telephone interview at 42 weeks.|||Z-score||95% Confidence Interval|Mean
833404|NCT01257581|Secondary|Lab Abnormal Reports by Treatment Assignment|The safety data is summarized according to treatment arm. Total number of Adverse Events (AEs), AEs that cause study drug withdrawal and abnormal laboratory tests are compared among treatment arms. A lab abnormality was a result that was out of range and considered clinically significant by the site investigator.|38 weeks of treatment followed by a telephone interview at 42 weeks.|||Events|||Number
833405|NCT01257581|Secondary|Dose Adjustments|These events were due to a double-blinded study design.|38 weeks of treatment followed by a telephone interview at 42 weeks.|||Number of Events due to Adverse Events|||Number
833406|NCT01257581|Secondary|Tracheostomy-free Survival|Secondary efficacy will be assessed by analyzing rate of tracheostomy-free survival at nine months.|38 weeks of treatment followed by a telephone interview at 42 weeks.|||proportion of participants||95% Confidence Interval|Number
833407|NCT01257581|Secondary|Vital Capacity/Pulmonary Function Testing|Secondary efficacy will be assessed by analyzing the change in the Slow Vital Capacity score over nine months. Vital Capacity is the maximum amount of air a person can expel from the lungs after a maximum inhalation. A subject's VC depends on their age, sex and height. The value is recorded as a percentage of predicted normal.|38 weeks of treatment followed by a telephone interview at 42 weeks.|||Percentage of predicted max value||95% Confidence Interval|Mean
833408|NCT01257581|Primary|Change in ALS Functional Rating Scale - Revised (ALSFRS-R)|Primary efficacy will be assessed by analyzing the mean rate of decline in the ALS Functional Rating Scale-Revised (ALSFRS-R) score over nine months. The ALSFRS-R is a quickly administered (5 min) ordinal rating scale used to determine a subject's assessment of their capability and independence in 12 functional activities. There are 12 questions, graded by the subject 0-4 (4 is normal). Score of 0 (worst) to 48 (best). Reflects speech and swallowing, fine motor skills, large motor skills, and breathing.|38 weeks of treatment followed by a telephone interview at 42 weeks.|||scores on a scale||95% Confidence Interval|Mean
833415|NCT01257802|Secondary|Mean Ovarian Volume.|Mean ovarian volume reflects the preservation of ovarian tissue despite exposure to cyclophosphamide; reduced ovarian size is documented in cyclophosphamide treated patients|baseline and 6 months|4 of the 7 subjects in the placebo arm dropped out of the study before reaching the 24 week (6 month) milestone, and 2 subjects of the 6 subjects receiving active drug did not have ultrasound performed at the 24 week (6 month) milestone||cubic centimeters||Standard Deviation|Mean
833416|NCT01257802|Secondary|Mean Antral Follicle Count (AFC)|Mean antral follicle count (AFC) is the average number of follicles counted in each of 2 ovaries|baseline and 6 months|4 of the 7 subjects in the placebo arm dropped out of the study before reaching the 24 week (6 month) milestone, and 2 subjects of the 6 subjects receiving active drug did not have ultrasound performed at the 24 week (6 month) milestone||# of ovarian follicles||Standard Deviation|Mean
833417|NCT01257802|Secondary|Number of Participants With Either an AMH Level of >1 ng/mL OR Antral Follicle Count of >4.|An AMH level of >1 ng/ml and/or an antral follicle count of >4 in either ovary is a strong predictor of residual ovarian function|baseline and 6 months|4 of the 7 subjects in the placebo arm dropped out of the study and 2 of the remaining subjects failed to have blood drawn at the 24 week (6 month) milestone, and 1 subject of the 6 subjects receiving active drug dropped out of the study before reaching the 24 week (6 month) milestone||Participants|||Count of Participants
833418|NCT01257802|Secondary|Count of Patients With AMH of ≤1.0 ng/mL vs >1 ng/mL,|AMH level ≤1.0 predicts onset of menopause within 5 years in normal women|baseline and 6 months|4 of the 7 subjects in the placebo arm dropped out of the study and 2 of the remaining subjects failed to have blood drawn at the 24 week (6 month) milestone, and 1 subject of the 6 subjects receiving active drug dropped out of the study before reaching the 24 week (6 month) milestone||Participants|||Count of Participants
833419|NCT01257802|Primary|Anti-mullerian Hormone (AMH) Measured as a Continuous Variable, Specifically Assessing the Intra-person Change From Study Entry (Day 0) to 6-month Post-intervention Visit|AMH was quantified in vitro a commercially available enzyme linked immunosorbent assay (ELISA) (Beckman Coulter; Marseille, France) was used for in vitro quantitative measurement of serum AMH.|Day 0 to 6-month post-intervention visit|8 subjects are listed in the breakdown of baseline characteristics. Samples were missing from one subject enrolled in the Placebo arm - therefore analysis throughout the majority of the reporting will include only 7 samples instead of 8 in the Placebo arm||ng/ml||Standard Deviation|Mean
833420|NCT01257880|Secondary|White Matter Lesions|Presence and severity of white matter lesions on magnetic resonance imaging, taken within 5 years prior to study enrollment. Subjects will not have magnetic resonance imaging performed as part of this study. Films will be requested and an independent neuroradiologist will assess presence of white matter lesions.|Within 5 years prior to enrollment||||||
833421|NCT01257880|Secondary|Oxygen Desaturation Index|Measurement of number of times per hour blood oxygen saturation decreases by at least 4% during home sleep study.|Baseline||||||
833422|NCT01257880|Primary|Cognitive Function|Cognitive function will be assessed by a battery of performance-based neuropsychological tests.|Baseline||||||
833423|NCT01257880|Primary|Sleep Apnea, Number of Participants|An apnea-hypopnea index (AHI) >10 per hour during a home sleep study, defined as at least 5 hours of recorded data on the portable sleep monitor instrument for either the apnea-hypopnea index (AHI) or oxygen desaturation index (ODI) and at least 3 hours for the other index. The scale adopted for assessment of sleep apnea is as follows: AHI < 5, optimal; AHI 5-10, equivocal, participant may have sleep apnea; AHI >10, sleep apnea highly likely.|Following one night of a home sleep study|The analysis was based on per protocol.||participants|||Number
833424|NCT01257880|Primary|Platelet Activation|Platelet-poor plasma levels of sCD40L and P-selectin, and serum concentration of TXB2.|Baseline||||||
833425|NCT01257880|Primary|Cerebral Vasomotor Reactivity (VMR)|"The percentage change in basilar artery blood flow velocity from baseline between hypercapnia (increased blood CO2) and hypocapnia (decreased blood CO2), as measured by transcranial Doppler during a single testing period. This is calculated using the following equation:
VMR = 100 x (VelocityHYPERCAPNIA - VelocityHYPOCAPNIA) / VelocityBASELINE"|Baseline|||Percentage change||Standard Deviation|Mean
833426|NCT01257880|Primary|Embolic Tracks|Embolic tracks on transcranial Doppler at rest and following calibrated Valsalva maneuver|Baseline||||||
833427|NCT01258049|Secondary|Number of Deaths or Neurological Sequelae at Day 28||28 days after start of treatment|||participants|||Number
833428|NCT01258049|Secondary|Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events, of Possible, Probably and Definite Causalities||28 days after start of treatment|||participants|||Number
833429|NCT01258049|Secondary|Time to Return to Normal Per os Status|Time in hours to return to normal per os status. Normal per os was when the investigator considered the patient to be able to eat and drink normally.|28 days after start of treatment|||hours||Standard Deviation|Mean
833430|NCT01258049|Secondary|Time to Return to Full Consciousness|"Time in hours to return to full consciousness (Blantyre Coma Scale = 5), if level of consciousness is reduced (Blantyre Coma Scale <5) prior to dosing or within 24hours of first dosing.
For the Blantyre Coma Scale
Total - maximum 5, eye movement - maximum 1, best motor response - maximum 2, best verbal response - maximum 2"|28 days after start of treatment|||hours||Standard Deviation|Mean
833431|NCT01258049|Secondary|Late Parasitological Failure|o Parasitaemia on any day from Day 7 to Day 28 and tympanic temperature ≤ 38.0°C|28 days after the start of treatment|||participants|||Number
833432|NCT01258049|Primary|Parasitological Success (PP)|Parasitological success defined as a reduction in parasite count of ≥ 90% of baseline at 24 hours after the first dose|24 hours after start of treatment|The Per Protocol (PP) population included the subjects in the MITT population who had received at least 80% of doses up to the time of discharge from the hospital, had evaluable data up to and including Day 28 and had no major protocol violations.||participants|||Number
833433|NCT01258049|Secondary|Late Clinical Failure|"Signs of severe malaria on any day between Day 4 and Day 28 in the presence of parasitaemia, without previously meeting any of the criteria of early treatment failure
Presence of parasitaemia and tympanic temperature ≥ 38.0°C (or history of fever), on any day between Day 4 and Day 28, without previously meeting any of the criteria of early treatment failure"|28 days after the start of treatment|||participants|||Number
833436|NCT01258049|Secondary|Fever Clearance Time (FCT)|Time in hours from the initiation of therapy until the disappearance of fever (tympanic temperature < 38.0) that lasted at least 24 hours.|28 days after start of treatment|||hours||Standard Deviation|Mean
833442|NCT01258049|Primary|Parasitological Success (MITT)|Parasitological success defined as a reduction in parasite count of ≥ 90% of baseline at 24 hours after the first dose|24 hours after start of treatment|"The Modified Intention to Treat (MITT) population included all randomised subjects who received at least one dose of study medication and had evaluable parasite counts at 24 hours after first dosing.
7 subjects for ArTiMist and 3 subjects for quinine were excluded due to no baseline or 24 h parasite count"||participants|||Number
833443|NCT01258101|Secondary|Time to Viral Response|Time to viral response was calculated as Date of first negative PCR result after screening – date of PCR screening sample + 1 [in days]. Mean of number of days to viral response for overall population were reported.|Up to Week 48|Standard analysis population includes all randomized participants.||Days||Standard Deviation|Mean
833444|NCT01258101|Secondary|Beck Depression Inventory Mean Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 4, 8, 12, 24 and 48|For the psychiatric assessment, the results of the Beck Depression Inventory (BDI) questionnaires were evaluated. BDI results were analyzed descriptively by visit, treatment group, genotype and opioid maintenance therapy status. BDI is 21 item participant rated inventory evaluates depression symptoms, cognition, and physical symptoms of fatigue, weight loss, lack of interest in sex. Individual items are scored on a 4 point scale (0 to 3), with 0=none/absent and 3=most severe. Total score: 0 to 63; higher score indicates more depression. Mean scores are presented by visit. Baseline is defined as Week 0.|At Baseline (Week 0) and Weeks 4, 8, 12, 24 and 48|Standard analysis population includes all randomized participants.||Score on a scale||Standard Deviation|Mean
833445|NCT01258101|Secondary|Mean Beschwerdeliste Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 16, 24 and 48|Psychiatric assessment were performed using Beschwerdeliste (BL) questionnaires. BL results were analyzed descriptively by visit, treatment group, genotype and opioid maintenance therapy status. The BL questionnaire items were scored by calculating the average response to all answered items. Items were graded 1=”stark” (affliction is strong) to 4=”gar nicht” (not present). The higher the BL score, the less afflictions were present for a participant. Baseline is defined as Week 0.|At Baseline (Week 0) and Weeks 16, 24 and 48|Standard analysis population includes all randomized participants.||Score on a scale||Standard Deviation|Mean
833446|NCT01258101|Secondary|Mean FSS Scores at Baseline and Weeks 16, 24 and 48|The Fatigue Severity Scale (FSS) is a self-administered instrument that includes 9 items rated on a 7-point scale, measuring fatigue severity. The participants were asked to score each statement, based on how the statement applied to them over the preceding week. The fatigue severity score is the average of the scores on the 9 questions; scores range from 1-7, with lower scores indicating less fatigue. Baseline is defined as Week 0.|At Baseline (Week 0) and Weeks 16, 24 and 48|Standard analysis population includes all randomized participants.||Score on a scale||Standard Deviation|Mean
833447|NCT01258101|Secondary|Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48|Short-Form Health Survey (SF-36) is a 36-item questionnaire measuring eight domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Each domain score ranges from 0 (worst) to 100 (best), with higher scores reflecting better health-related functional status. Where Baseline (BS) is Week 0.|At Baseline (Week 0) and Weeks 16, 24 and 48|Standard analysis population includes all randomized participants.||Score on a scale||Standard Deviation|Mean
833448|NCT01258101|Secondary|Median Hemoglobin Levels at End of Treatment|Hemoglobin (Hb) levels at end of treatment (Week 16 and Week 24) were reported. The mean lowest Hb value after treatment starts with a median of 129 gram (g)/Litre (L). The far most frequent hemoglobin class was >=100 g/L. The purpose of assessing the Hb levels is associated with ribavirin dose. The primary toxicity of ribavirin dose (1000-1200 mg/day, maximum tolerated dose) is anemia with a reduction in hemoglobin levels generally occurring within the first 1-2 weeks of initiating therapy. Decreases in hemoglobin seen in the combination treatment of ribavirin and Interferon-alfa are managed with reduction in ribavirin dosage to 600 mg/day.|At Week 16 and Week 24|The Safety analysis population was defined to include only participant who received at least one dose of (either) study medication and had at least one post-baseline safety assessment.||g/L||Inter-Quartile Range|Median
833449|NCT01258101|Secondary|Number of Participants With Any Adverse Events and Any Serious Adverse Events|An adverse event (AE) was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A Serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.|Up to Week 48|The Safety analysis population was defined to include only participants who received at least one dose of (either) study medication and had at least one post-baseline assessment.||Number of Participants|||Number
833450|NCT01258101|Secondary|Percentage of Participants With Virologic Response Rates as Per Genotype at End of Treatment|Virologic Response was defined as undetectable HCV-RNA levels (determined by AMPLICOR HCV test) at Week 16 and Week 24. Virologic response rates based on genotype (G2 and G3) were reported. ETR is defined as Week 16 and Week 24.|At Week 16 and Week 24|Standard analysis population includes all randomized participants.||Percentage of participants||95% Confidence Interval|Number
833451|NCT01258101|Secondary|Percentage of Participants With Virological Response at the End of the Treatment|Virological response at the end of the treatment (ETR) was defined as the percentage of participants with negative qualitative PCR in each group at completion of the treatment. ETR is defined as Week 16 and Week 24.|At Week 16 and Week 24|Standard analysis population includes all randomized participants.||Percentage of participants||95% Confidence Interval|Number
833452|NCT01258101|Primary|Percentage of Participants With Hepatitis C Virus-RNA Determined by AMPLICOR HCV Test At Week 24 and Week 48|Serum Hepatitis C Virus-RNA (HCV-RNA) was done by Polymerase chain reaction (PCR). Samples for a qualitative PCR (AMPLICOR® HCV Test v2.0) were obtained at Week 24 and Week 48. 'G2' and 'G3' indicates Genotype 2 and Genotype 3 respectively.|At Week 24 and Week 48|Standard analysis population includes all randomized participants.||Percentage of participants||95% Confidence Interval|Number
834225|NCT01275625|Secondary|Immunological Response at Week 48: Percentage Change From Baseline in Absolute Cluster of Differentiation 4 (CD4)|Immunological Response was summarized using percentage change from Baseline to Week 48 in absolute CD4+ cell count|Week 48|FAS Population included those participants who had taken at least 1 dose of the study drug.||Percent||Standard Deviation|Mean
833453|NCT01258101|Primary|Percentage of Participants Who Achieve Sustained Virologic Response Rate At 24 Weeks Post Completion of the Treatment|Sustained virological response was defined as the percentage of participants in each group with undetectable Hepatitis C virus-Ribonucleic acid (HCV-RNA) measurement at 24 weeks post completion of the treatment.|Up to Week 48 (24 weeks post completion of the treatment)|Standard analysis population includes all randomized participants.||Percentage of participants||95% Confidence Interval|Number
833454|NCT01258153|Secondary|Safety and Tolerability Will be Assessed in Terms of Frequency and Severity of AEs as Well as Frequency of Clinically Significant Changes in Physical Examination and Lab Test.|Safety and tolerability will be assessed for the Safety Population (all patients who received the study drug) in terms of frequency and severity of AEs as well as frequency of clinically significant changes in physical examination and lab test.|up to four weeks|All patients receiving the study drug (114)||Adverse events|||Number
833455|NCT01258153|Secondary|Absolute Change in the Overall Parental Judgment After Treatment Discontinuation Versus Baseline|"On a daily basis parents expressed an overall judgement on the study treatment effect based on a 6 rate categorical scale from 0 to 5 (where 0 is for Not at all and 5 is Extremely.
The question was How frustrating to you was your baby's crying today?)"|10 days|ITT - defined as the safety population randomised with at least 24h diary recording post 1st dose of study treatment||Score range 0-5|Participants|Standard Deviation|Mean
833456|NCT01258153|Secondary|Absolute Change in the Overall Parental Judgment at the End of Treatment Versus Baseline|"On a daily basis parents expressed an overall judgement on the study treatment effect based on a 6 rate categorical scale from 0 to 5 (where 0 is for Not at all and 5 is Extremely.
The question was How frustrating to you was your baby's crying today?)"|1 week|ITT - defined as the safety population randomised with at least 24h diary recording post 1st dose of study treatment||Score range 0-5|Participants|Standard Deviation|Mean
833457|NCT01258153|Secondary|Absolute Change in the Overall Parental Judgment After the First Dose of Treatment Versus Baseline|"On a daily basis parents expressed an overall judgement on the study treatment effect based on a 6 rate categorical scale from 0 to 5 (where 0 is for Not at all and 5 is Extremely.
The question was How frustrating to you was your baby's crying today?)"|1 day|ITT - defined as the safety population randomised with at least 24h diary recording post 1st dose of study treatment||Score range 0-5|Participants|Standard Deviation|Mean
833458|NCT01258153|Secondary|Percentage of 'Responder' Babies at the End of Treatment Period.|Response is defined as a decrease of at least 50% of crying and fussing time during the last 3 days on treatment vs baseline.|baseline and one week|112 instead of 113, because 1 subject had no records at baseline and therefore the outcome could not be measured||Responders Rate (% of responders babies)|||Number
833459|NCT01258153|Primary|Absolute Change of the Mean Daily Crying and Fussing Time for Three Consecutive Days While on Treatment Versus Baseline.|Efficacy assessment to be measured through “baby’s day” diary recorded for three consecutive days while on treatment (i.e. starting from 6 pm on Day 4 and continued for 72 hours) vs baseline (i.e. starting from 6 pm on Day -4 until 1st treatment administration).|Baseline and one week|112 instead of 113, because 1 subject had no records at baseline and therefore the outcome could not be measured||Minutes||Standard Deviation|Mean
833460|NCT01258387|Secondary|Change From Baseline of 2D-ECHO Measured by End-Systolic Volume (ESV)|"ESV is the volume of blood remaining in each ventricle at the end of systole.¹
¹http://medical-dictionary.thefreedictionary.com/end-diastolic+volume"|Screening, day 8, day 14, day 28, and 3 months post-dose|Safety Population||Milliliter(s)||Standard Deviation|Mean
833461|NCT01258387|Secondary|Change From Baseline of 2D-ECHO Measured by End-Diastolic Volume (EDV)|"EDV is the amount of blood in the ventricle immediately before a cardiac contraction begins; used as a measurement of diastolic function.¹
¹http://medical-dictionary.thefreedictionary.com/end-diastolic+volume"|Screening, day 8, day 14, day 28, and 3 months post-dose|Safety Population||Milliliter(s)||Standard Deviation|Mean
833462|NCT01258387|Secondary|Change From Baseline of Two-Dimensional Echocardiogram (2D-ECHO) Measured by Ejection Fraction (EF)|"An echocardiogram is a type of ultrasound test that uses high-pitched sound waves that are sent through a device called a transducer. The device picks up echoes of the sound waves as they bounce off the different parts of your heart. These echoes are turned into moving pictures of your heart that can be seen on a video screen.¹
Ejection fraction is a measurement of the percentage of blood leaving your heart each time it contracts.²
¹http://wakeinternalmedicine.com/services-and-procedures/services/radiology/2d-echo/
²http://www.mayoclinic.org/ejection-fraction/expert-answers/faq-20058286"|Screening, day 8, day 14, day 28, and 3 months post-dose|Safety Population||percent change||Standard Deviation|Mean
833463|NCT01258387|Primary|Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs)|"Safety/ tolerability of single dose; cumulative safety over 6 months
TEAEs are defined as adverse events with date of onset (or worsening) on or after the start date of double-blind treatment and no more than 28 days from the start date of double-blind treatment."|6 months|Safety population||participants|||Number
833464|NCT01258504|Primary|Cmax of Bosentan||after first dose, at steady-state and during SJW|||ng/ml||95% Confidence Interval|Geometric Mean
833465|NCT01258504|Primary|AUC of Bosentan||0-infinity; during dosing interval|||h*ng/ml||95% Confidence Interval|Geometric Mean
833466|NCT01258582|Primary|Acceptability of the HIV Test|The primary outcome measure was HIV test acceptance rate defined by the proportion of participants whom accepted HIV testing among those randomized within each trial arm (fingerstick or oral fluid).|Assess on day subject enrolled into the study|Intent to treat analysis||proportion of participants||95% Confidence Interval|Number
833467|NCT01258595|Secondary|Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine|Solicited Injection Site Reactions: Pain, Erythema, Swelling, Ecchymosis, and Induration. Solicited Systemic Reactions: Fever, Headache, Malaise, Myalgia, and Shivering|Day 0 through Day 7 post-vaccination|Safety analysis was on all enrolled and vaccinated subjects with available reaction data, safety analysis set population.||Participants|||Number
833468|NCT01258595|Primary|Percentage of Participants With Seroprotection Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine|Seroprotection was defined as a titer ≥ 40 (1/dilution [1/dil]). Serum antibody titers were assessed by means of the hemagglutination inhibition (HAI) assay method.|Day 0 and Day 28 post vaccination|Seroprotection was assessed in the full analysis set population.||Percentage of Participants|||Number
833469|NCT01258595|Primary|Percentage of Participants With Seroconversion After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine|"Seroconversion: For participants with a Day 0 (pre-vaccination) titer < 10 (1/dilution [1/dil]) a titer ≥ 40 (1/dil), and for participants with a Day 0 titer ≥ 10 (1/dil) a ≥ 4 fold increase of titer on Day 28.
Serum antibody titers were assessed by means of the hemagglutination inhibition (HAI) assay method."|Day 0 and Day 28 post-vaccination|Seroconversion to the vaccine antigens was assessed in the full analysis set population.||Percentage of Participants|||Number
833470|NCT01258595|Primary|Geometric Mean of Individual Titer Ratios (GMTRs) of Vaccine Antibodies Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine|Serum antibody titers to vaccine antigens were assessed by means of the hemagglutination inhibition (HAI) assay method.|Day 0 and Day 28 Post-vaccination|Serum antibody titers to vaccine antigens were assessed in the full analysis set population.||1/dilution (1/dil)||95% Confidence Interval|Geometric Mean
833471|NCT01258595|Primary|Geometric Mean Titers (GMTs) of Vaccine Antibodies Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine.|Serum antibody titers to vaccine antigens were assessed by means of the hemagglutination inhibition (HAI) assay method.|Day 0 and Day 28 post-vaccination|Serum antibody titers to vaccine antigens were assessed in the full analysis set population.||1/dilution (1/dil)||95% Confidence Interval|Geometric Mean
833472|NCT01258660|Secondary|Homocysteine Concentrations in Plasma at Baseline and at the End of Treatment (Week 24) With Folic Acid|Homocysteine concentrations in plasma at baseline (median of baseline concentrations) and at the end of treatment (week 24) with folic acid|baseline, and up to 24 weeks of treatment|||µmol/L||Standard Deviation|Mean
833473|NCT01258660|Secondary|Homocysteine Concentrations in Plasma at Baseline and at the End of Treatment (Week 24) With Metafolin|Homocysteine concentrations in plasma at baseline (median of baseline concentrations) and at the end of treatment (week 24) with Metafolin|baseline and week 24|||µmol/L||Standard Deviation|Mean
833474|NCT01258660|Secondary|Folate Metabolite Pattern in Plasma at Cycle 6|Folate metabolite pattern in plasma at cycle 6|week 24|||nmol/L||Standard Deviation|Mean
833475|NCT01258660|Secondary|Folate Metabolite Pattern in Plasma at Cycle 3|Folate metabolite pattern in plasma at cycle 3|week 12|||nmol/L||Standard Deviation|Mean
833476|NCT01258660|Secondary|Folate Metabolite Pattern in Plasma at Baseline|Folate metabolite pattern in plasma at baseline|pre-treatment|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.||nmol/L||Standard Deviation|Mean
833477|NCT01258660|Primary|Proportion of Participants With RBC Folate Below 906 Nmol/L in the Yasmin + Metafolin Group in the Folate Elimination Phase (Week 24 to 44)|Proportion of participants with RBC folate below 906 nmol/L in the Yasmin + Metafolin group in the folate elimination phase (week 24 to 44)|from week 24 to week 44|||proportion of participants|||Number
833478|NCT01258660|Primary|Area Under the Curve From Time 0 to 24 Weeks [AUC(0-24weeks)] for Plasma Folate and RBC (Red Blood Cell) Folate (Baseline Corrected)|The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.|up to 24 weeks of treatment|||nmol·week/L||95% Confidence Interval|Geometric Mean
833479|NCT01258660|Primary|Area Under the Curve (AUC) From Time 0 to 24 Weeks [AUC(0-24weeks)] for Plasma Folate and RBC (Red Blood Cell) Folate (Baseline Uncorrected)|The Area under the curve (AUC) is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.|up to 24 weeks of treatment|||nmol·week/L||95% Confidence Interval|Geometric Mean
833480|NCT01258738|Secondary|Percentage of Participants Achieving Patient Acceptable Symptom State (PASS) at Time Points|PASS is defined as a symptom state that the participants consider acceptable.|Weeks 12 and 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Percentage of participants|||Number
833481|NCT01258738|Secondary|Percentage of Participants With Minimally Clinically Important Improvement (MCII) at Time Points|The MCII asks participants to rate the level of improvement they have experienced in the 48 hours compared to when they started the study. Response options are “Improved - less pain”, “No change”, and “Worse – more pain.” If the participant indicates that improvement has occurred, then they are asked to indicate how important that improvement is to them from “Not at all important” to “Very important’.|Weeks 12 and 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Percentage of participants|||Number
833482|NCT01258738|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale Score From Baseline to Week 104|The MOS sleep scale consists of 12 items to measure 6 sleep dimensions: initiation (time to fall asleep), quantity (hours of sleep each night), maintenance, respiratory problems, perceived adequacy, somnolence (the last 4 items reported using a 6-item Likert scale ranging from 1 [all of the time] to 6 [none of the time]). The raw scores ranging from 1 to 6 are transformed to scores ranging from 0 to 100 before the indices are calculated. Therefore the reported scores, consisting of means of converted items, also range from 0 to 100. However, two indexes can be derived: Sleep problems index I (short form) and sleep problems index II (long form). Additional subscales can be derived: sleep disturbance, snoring, awaken shortness of breath or headache, sleep adequacy, sleep somnolence, sleep quantity, and optimal sleep. However, data for two indexes and additional subscales is not reported.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Mean
833499|NCT01258738|Secondary|Mean Change From Baseline in Dactylitis Score at Time Points|Each of the 10 fingers and 10 toes is evaluated for dactylitis. A score of 0, 1, 2 or 3 (where 0 = none, 1= mild, 2 = moderate, 3 = severe) is assigned to each. A total score which can range from 0 to 60 is obtained by adding the scores for the 20 digits|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Mean
833483|NCT01258738|Secondary|Change From Baseline in Multidimensional Fatigue Inventory (MFI) Score at Time Points|"The MFI is a 20-item questionnaire that evaluates several aspects of fatigue. The General Fatigue Item is disclosed here. The general fatigue item contains four items, two of which are indicative for fatigue and two items contra-indicative for fatigue. Indicative items (eg, I tire easily) are formulated in such a way that a high score suggests a high degree of fatigue. In case of contra-indicative items (eg, I feel fit) a high score indicates a low degree of fatigue. Each item is scored on a 5-point numeric rating scale anchored at each end by “Yes, that is true” (scored 1) to “No, that is not true” (scored 5). Scoring for the MFI is done in such a way that higher scores indicate greater fatigue. Therefore, the items indicative for fatigue need to be recoded (1=5, 2=4, 3=3, 4=2, 5=1). For each scale a total score is calculated by summation of the scores of the individual items. Scores can range from the minimum of 4 to the maximum of 20. MFI-20 scale is copyrighted."|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Mean
833484|NCT01258738|Secondary|Changes From Baseline in WPAI - Overall Work Impairment Due to Health Problems at Time Points|"The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated:
Percent overall work impairment due to health problem:
Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))*(Q5/10)]. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity."|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA.||Units on a scale||Standard Error|Mean
833485|NCT01258738|Secondary|Changes From Baseline in WPAI - Activity Impairment Due to Health Problems at Time Points|"The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated:
Percent activity impairment due to health problem: Q6/10. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity."|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA.||Units on a scale||Standard Error|Mean
833486|NCT01258738|Secondary|Change From Baseline in WPAI: Percent Impairment While Working Due to Health Problems at Time Points|"The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated:
Percent impairment while working due to health problem: Q5/10. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity."|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA.||Units on a scale||Standard Error|Mean
833487|NCT01258738|Secondary|Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed Due to Health Problems at Time Points|"The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated:
Percent work time missed due to health problem: Q2/(Q2+Q4). The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity."|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA.||Units on a scale||Standard Error|Mean
833488|NCT01258738|Secondary|Change From Baseline in Ankylosing Spondylitis Work Instability Index (AS-WIS) Score at Time Points|The AS-WIS is a 20 item questionnaire to assess work disability and risk of unemployment due to AS. Higher scores indicate greater work impairment and instability that results from a mismatch between an individual’s ability levels given their AS and their job. Each question is assigned a score of 1 for a response of “True” and 0 for a response of “Not True”. All item scores are summed to give a total score that can range from 0 to 20. If a subject has ≥ 5 missing responses (ie more than 20%), then a total score is not calculated. For subjects with ≥ 1 but ≤ 4 missing responses, the total score is calculated as follows: T=20x/(20-m) where: T is the total score, x is the total score for the items answered and n is the number of non-missing items.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Mean
833489|NCT01258738|Secondary|Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) Score at Time Points|ASQoL is a questionnaire that assesses disease-specific quality of life (QoL). It consists of 18 statements that are relevant to the physical and mental conditions for a participant with Ankylosing Spondylitis (AS): mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each statement is answered by the participant as a 'Yes' (scored as 1) or 'No' (scored as 0). All item scores are summed to give a total score. Total score can range from 0 (good QoL) to 18 (poor QoL).|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA.||Units on a scale||Standard Error|Mean
833490|NCT01258738|Secondary|Change From Baseline in HADS Anxiety Score at Time Points|This outcome measure is describing the HADS subscale of anxiety. HADS is a participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms. There is no Total Score for HADS.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Mean
833491|NCT01258738|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Depression Score at Time Points|This outcome measure is describing the HADS subscale of depression. HADS is a participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms. There is no Total Score for HADS.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Mean
833492|NCT01258738|Secondary|Change From Baseline in SF-36 Mental Component Summary (MCS) at Time Points|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA.||Units on a scale||Standard Error|Mean
833493|NCT01258738|Secondary|Change From Baseline in Short Form-36 (SF-36) Physical Component Summary (PCS) at Time Points|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100 = highest level of functioning).|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA.||Units on a scale||Standard Error|Mean
833494|NCT01258738|Secondary|Change From Baseline in EQ-5D Health State Profile Utility Score at Time Points|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA.||Units on a scale||Standard Error|Mean
833495|NCT01258738|Secondary|Change From Baseline in Euro Quality of Life (EQ)-5D VAS Score Time Points|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA.||mm||Standard Error|Mean
833496|NCT01258738|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Time Points|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||mm/hr||Standard Error|Mean
833497|NCT01258738|Secondary|Change From Baseline in C-reactive Protein (CRP) Concentration Time Points|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||mg/L||Standard Error|Mean
833498|NCT01258738|Secondary|Changes From Baseline in Maastricht Ankylosing Spondylitis Enthesis Score (MASES) at Time Points|Assessment of enthesitis was performed in the following 7 domains: 1) 1st costochondral joint left and right, 2) 7th costochondral joint left and right, 3) posterior superior iliac spine left and right, 4) anterior superior iliac spine left and right, 5) iliac crest left and right, 6) 5th lumbar spinous process and 7) proximal insertion of Achilles tendon left and right. Each domain was graded for the presence (1) and absence (0) of tenderness yielding total MASES ranging from 0 (no tenderness) to 13 (worst possible score; severe tenderness).|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Mean
833569|NCT01266876|Secondary|Percent Change From Baseline in Triglycerides at Week 12 - On-treatment Analysis|Since the assumptions of normal distribution and equality of variances were not verified for the lipid parameter, percent changes were expressed as median (interquartile range)|From Baseline to Week 12 (LOCF)|mITT population included all randomized participants with one baseline and at least one post baseline on-treatment fasting triglycerides value.||percent change||Inter-Quartile Range|Median
833500|NCT01258738|Secondary|Mean Change From Baseline in Number of Tender Joints at Time Points|Forty-four (44) joints were assessed by the Investigator to determine the number of joints that were considered tender or painful. The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be considered for artificial joints). The 44 joints to be assessed were:sternoclavicular, acromioclavicular, shoulder, elbow, wrist (includes radiocarpal, carpal and carpometacarpal considered as one unit), metacarpophalangeals (I, II, III, IV, V), thumb interphalangeal (IP), proximal IPs (II, III, IV, V), knee, ankle, metatarsophalangeals (I, II, III, IV, V).|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Number of joints||Standard Error|Mean
833501|NCT01258738|Secondary|Mean Change From Baseline in Number of Swollen Joints at Time Points|Forty-four (44) joints were assessed by the Investigator to determine the number of joints that were considered swollen (artificial joints were not assessed). The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done. The 44 joints to be assessed were:sternoclavicular, acromioclavicular, shoulder, elbow, wrist (includes radiocarpal, carpal and carpometacarpal considered as one unit), metacarpophalangeals (I, II, III, IV, V), thumb interphalangeal (IP), proximal IPs (II, III, IV, V), knee, ankle, metatarsophalangeals (I, II, III, IV, V).|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Number of joints||Standard Error|Mean
833502|NCT01258738|Secondary|Mean Change From Baseline in Ankylosing Spondylitis Spine Magnetic Resonance Imaging-Activity (ASspiMRI-a) Total Score|ASspiMRI-a measures acute lesion scores as determined by short-tau inversion recovery (STIR) and gadolinium-enhanced T1 (Gd-DTPA). All 23 disco-vertebral units (DVU) of the spine (from C2 to S1), defined as the region between 2 virtual lines through the middle of each vertebra, are scored in a single dimension, which is representing the highest level of inflammation in that particular DVU. Enhancement and bone marrow edema are graded (0-3) for each DVU, with 3 more grades (4-6) if, in addition to the signs of acute inflammation defined for grades 1-3, erosions are visualized, leading to a maximum score of 138 for the entire spine. Acute spinal changes were assessed by using STIR sagittal views of the cervical, thoracic and lumbar spine. The total score ranges from 0 (no inflammation) to 138 (high inflammation).|Weeks 12 and 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through observed cases||Units on a scale||Standard Error|Mean
833503|NCT01258738|Secondary|Mean Change From Baseline in SPARCC - Spine 6 Discovertebral Units (DVU) Total Score at Time Points|The change from baseline in the MRI score of spine was assessed using SPARCC method. The scores of the 6 most severely affected spinal levels (discovertebral units/DVUs) was selected. Each DVU was divided into 4 quadrants. Each quadrant was assigned a score of 0 = no lesion or 1 = increased signal. This was repeated for each of 3 consecutive sagittal slices resulting in a score of up to 12 per DVU. On each slice, the presence of a lesion exhibiting an intense signal in any quadrant was assigned an additional score of 1 for that slice. Additionally, on each slice the presence of a lesion exhibiting depth ≥ 1 cm in any quadrant was given an additional score of 1. The maximum score for 6 DVU Spine Total Score is 108.|Weeks 12 and 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through observed cases.||units on a scale||Standard Error|Mean
833504|NCT01258738|Secondary|Mean Change From Baseline in SPARCC Score for the Sacroiliac Joint at Time Points|The change from baseline in the MRI score of sacroiliac joints was assessed using SPARCC method. Scoring was based on 6 consecutive coronal slices from posterior to anterior. Each joint was divided into 4 quadrants. Each quadrant was assigned a score of 0 = no lesion/1 = increased signal. For each slice, the score is increased by 1 for each joint that exhibits an intense signal in any quadrant. Also, for each slice, an additional score of 1 will be given for each joint that includes a lesion demonstrating continuous increased signal of a depth ≥1 cm from the articular surface. The maximum possible score is 72.|Weeks 12 and 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through observed cases.||units on a scale||Standard Error|Mean
833505|NCT01258738|Secondary|Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) - Spine 6 Discovertebral Units (DVU) Total Score at 12 Weeks|The change from baseline in the MRI score of spine was assessed using SPARCC method. The scores of the 6 most severely affected spinal levels (discovertebral units/DVUs) was selected. Each DVU was divided into 4 quadrants. Each quadrant was assigned a score of 0 = no lesion or 1 = increased signal. This was repeated for each of 3 consecutive sagittal slices resulting in a score of up to 12 per DVU. On each slice, the presence of a lesion exhibiting an intense signal in any quadrant was assigned an additional score of 1 for that slice. Additionally, on each slice the presence of a lesion exhibiting depth ≥ 1 cm in any quadrant was given an additional score of 1. The maximum score for 6 DVU Spine Total Score is 108.|Week 12|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through observed cases.||units on a scale||Standard Error|Mean
833506|NCT01258738|Secondary|Mean Change From Baseline in Occiput-to-wall Test at Time Points|Occiput-to-wall distance: distance between the occiput (posterior or back portion of the head) and the wall when the participant stood with heels and shoulder against the wall and the back straight.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||cm||Standard Error|Mean
833570|NCT01266876|Secondary|Absolute Change From Baseline in HDL-C at Week 12 - On-treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|From Baseline to Week 12 (LOCF)|mITT population included all randomized participants with one baseline and at least one post baseline HDL-C value.||mg/dL||Standard Error|Least Squares Mean
833507|NCT01258738|Secondary|Change From Baseline in Chest Expansion at Time Points|Chest expansion, measured in cm, is defined as the difference in thoracic circumference during full expiration versus full inspiration, measured at the fourth intercostal space (nipple line). At maximal inspiration, the chest circumference was measured at nipple line or at the 4th intercostal space (in cm to the nearest 0.1 cm).|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||cm||Standard Error|Mean
833508|NCT01258738|Secondary|Mean Change From Baseline in BASMI Tragus to Wall Score by Time Point|BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Mean
833509|NCT01258738|Secondary|Mean Change From Baseline in BASMI Intermalleolar Distance Score by Time Point|BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Mean
833510|NCT01258738|Secondary|Mean Change From Baseline in BASMI Modified Schobers Test Score by Time Point|BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Mean
833511|NCT01258738|Secondary|Mean Change From Baseline in BASMI Cervical Rotation Degree by Time Point|BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Mean
833512|NCT01258738|Secondary|Mean Change From Baseline in BASMI Lateral Side Flexion Score by Time Point|BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Mean
833513|NCT01258738|Secondary|Mean Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Total Score at Time Points|BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Mean
833514|NCT01258738|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Total Score at Time Points|The BAS-G was a 2 question assessment evaluating the effect of AS on the participants well-being over the last week and last 6 months. The 2 questions were: How have you been over the last week? and How have you been over the last six months?. Each question is scored by the participant on a 100 mm scale ranging from 0 (Very Good) to 100 (Very Bad). The two values are averaged to obtain the BAS-G score.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Mean
833515|NCT01258738|Secondary|Percentage of Participants With BASDAI 20 at Time Points|Response was defined as a 20% improvement of the Baseline BASDAI to 104 weeks of study treatment. The BASDAI score is obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 and 6) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Percentage of participants|||Number
833516|NCT01258738|Secondary|Percentage of Participants With BASDAI 50 at Time Points|Response was defined as a 50% improvement of the Baseline BASDAI to 104 weeks of study treatment, respectively. The BASDAI score is obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 and 6) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Percentage of participants|||Number
834475|NCT01278927|Secondary|SF-36 Late Outcomes|The SF-36 PCS and MCS will be collected from participants at six months. Raw scores are converted to a standard metric (0-100), with higher scores being indicative of a better health state.|6 months|||units on a scale||Standard Deviation|Mean
833517|NCT01258738|Secondary|Mean Change From Baseline in BASDAI Level of Neck/Back/Hip Pain at Time Points|BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a VAS of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 and 6) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The final BASDAI score averages the individual assessments for a final score range of 0-10.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Mean
833518|NCT01258738|Secondary|Mean Change From Baseline in BASDAI Level of Pain/Swelling at Time Points|BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a VAS of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 and 6) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The final BASDAI score averages the individual assessments for a final score range of 0-10.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Mean
833519|NCT01258738|Secondary|Mean Change From Baseline in BASDAI Level of How Long Stiffness Lasts at Time Points|BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a VAS of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 and 6) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The final BASDAI score averages the individual assessments for a final score range of 0-10.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Mean
833520|NCT01258738|Secondary|Mean Change From Baseline in BASDAI Level of Discomfort at Time Points|BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a VAS of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 and 6) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The final BASDAI score averages the individual assessments for a final score range of 0-10.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Mean
833521|NCT01258738|Secondary|Mean Change From Baseline in BASDAI Level of Fatigue/Tiredness at Time Points|BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a VAS of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 and 6) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The final BASDAI score averages the individual assessments for a final score range of 0-10.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Mean
833522|NCT01258738|Secondary|Mean Change From Baseline in BASDAI Level of Morning Stiffness at Time Points|BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a VAS of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 and 6) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The final BASDAI score averages the individual assessments for a final score range of 0-10.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Mean
833523|NCT01258738|Secondary|Changes From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at Time Points|BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a VAS of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 and 6) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The final BASDAI score averages the individual assessments for a final score range of 0-10.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Mean
833571|NCT01266876|Secondary|Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 - On-treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint..|From Baseline to Week 12 (LOCF)|mITT population included all randomized participants with one baseline and at least one on-treatment HDL-C value.||percent change||Standard Error|Least Squares Mean
833524|NCT01258738|Secondary|Mean Change From Baseline in BASFI Putting on Socks at Time Points|BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Mean
833525|NCT01258738|Secondary|Mean Change From Baseline in BASFI Looking Over Shoulder at Time Points|BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Mean
833526|NCT01258738|Secondary|Mean Change From Baseline in BASFI Standing Unsupported for 10 Minutes at Time Points|BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Mean
833527|NCT01258738|Secondary|Mean Change From Baseline in BASFI Getting-up Off-floor From Back at Time Points|BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Mean
833528|NCT01258738|Secondary|Mean Change From Baseline in BASFI Climbing Steps Without Aid at Time Points|BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Mean
833529|NCT01258738|Secondary|Mean Change From Baseline in BASFI Reaching up High at Time Points|BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Mean
833530|NCT01258738|Secondary|Mean Change From Baseline in BASFI Physically Demanding Activities at Time Points|BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Mean
833531|NCT01258738|Secondary|Mean Change From Baseline in BASFI Getting Out of an Arm-less Chair at Time Points|BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Mean
833532|NCT01258738|Secondary|Mean Change From Baseline in BASFI Bending Forward at Time Points|BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Mean
833533|NCT01258738|Secondary|Mean Change From Baseline in BASFI Full Day Activities at Time Points|BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Mean
834368|NCT01267175|Secondary|Usability of the Training Material Meets Expectations|Questionnaire completed at the end of the study, measuring usability of the device training manual. Results scored on a Likert scale of 1 - 7, 1 being the least user friendly and 7 being the most user friendly.|5 weeks|||Scores on a scale||Standard Deviation|Mean
833534|NCT01258738|Secondary|Changes From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Time Points|BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Mean
833535|NCT01258738|Secondary|Changes From Baseline in VAS Score for Total Back Pain at Time Points|The VAS scale was used to assess the level of total back pain during the past 48 hours. For this, participants marked their level of pain on a 100 mm VAS anchored by 0 for “No pain ” to 100 mm for “Most Severe Pain.”|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach. The values were converted to cm for analysis purposes.||cm||Standard Error|Mean
833536|NCT01258738|Secondary|Changes From Baseline in VAS Score for Nocturnal Back Pain at Time Points|The VAS scale was used to assess the level of nocturnal pain during the past 48 hours. For this, participants marked their level of pain on a 100 mm VAS anchored by 0 for “No pain ” to 100 mm for “Most Severe Pain.”|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach. The values were converted to cm for analysis purposes.||cm||Standard Error|Mean
833537|NCT01258738|Secondary|Mean Change From Baseline in VAS Score for Subject Assessment of Disease Activity at Time Points|Participants to assess their overall disease activity over the last 48 hours using a pain scale between 0 mm (none) and 100 mm (severe), which corresponded to the magnitude of their pain.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach. The values were converted to cm for analysis purposes.||cm||Standard Error|Mean
833538|NCT01258738|Secondary|Mean Change From Baseline in Visual Analogue Scale (VAS) Physician Global Assessments at Time Points|The Investigator estimated the participant’s overall disease activity over the previous 48 hours (this was independent of the Subject Assessment of Disease Activity) using a scale between 0 mm (none) and 100 mm (severe).|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach. The values were converted to cm for analysis purposes.||cm||Standard Error|Mean
833539|NCT01258738|Secondary|Time to ASAS Partial Remission|The median time to partial remission was not reached at Week 12. Hence, we report an estimate of the percentage of participants, estimated using Kaplan-Meier approach.|Week 12|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA.||percentage of participants||95% Confidence Interval|Number
833540|NCT01258738|Secondary|Percentage of Participants Achieving ASAS Partial Remission at Time Points|Partial remission defined as a score of 20 units or less (on a scale of 0-100, where 0 = no disease activity and 100 = high disease activity) in each of the 4 Assessment in ASAS domains: participant global assessment of disease activity, pain, function, and inflammation. For scale, 100 = high disease activity.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Percentage of participants|||Number
833541|NCT01258738|Secondary|Mean Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) High Sensitivity CRP (hsCRP) Score at Time Points|ASDAS includes CRP (mg/L) or ESR (mm/hr); Apart from the value of CRP or ESR, the four additional self-reported items (rated on 0-10cm VAS or 0-10 numerical rating scale [NRS]) included in this index are back pain, duration of morning stiffness, peripheral pain/swelling and patient global assessment of disease activity. The ASDAS scores are then calculated as follows: ASDAS_CRP = (0.121 x total back pain) + (0.110 x subject global) + (0.073 x peripheral pain/swelling) + (0.058 x duration of morning stiffness) + (0.579 x Ln(CRP+1)). And ASDAS_ESR: (0.079 x total back pain) + (0.113 x subject global) + (0.086 x peripheral pain/swelling) + (0.069 x duration of morning stiffness) + (0.293 x √ESR). In addition, the proportion of participants who achieve inactive disease based on the ASDAS will be determined for each group. Inactive disease is defined as an ASDAS score <1.3.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Mean
833542|NCT01258738|Secondary|Percentage of Participants Achieving ASAS 5/6 Response at Time Points|ASAS 5/6 consists of 6 domains: the 4 used in ASAS 20 (participant global assessment of disease activity, pain, function, inflammation measured on a 0-100 scale, where 0 = no disease activity and 100 = high disease activity) plus spinal mobility and an acute phase reactant, C Reactive Protein (CRP). Achieving ASAS 5/6 requires a 20% improvement compared to baseline in ≥ 5 domains and no worsening in the remaining domain.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Percentage of participants|||Number
833543|NCT01258738|Secondary|Percentage of Participants Achieving ASAS 20 Response at Time Points|ASAS measures symptomatic improvement in AS in 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement from baseline and an absolute change ≥ 10 units on a 0-100 scale (0=no disease activity; 100 = high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Percentage of participants|||Number
834476|NCT01278927|Secondary|Days of Hospitalization|The number of hospital days within the first 100 days after graft infusion will be collected for patients surviving at least 100 days.|100 days|||days||Standard Deviation|Mean
833544|NCT01258738|Secondary|Percentage of Participants Achieving ASAS 40 Response at Time Points|ASAS measures symptomatic improvement in AS in 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40% improvement from baseline and an absolute change ≥ 20 units on a 0-100 scale (0 = no disease activity, 100 = high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Percentage of participants|||Number
833545|NCT01258738|Primary|Percentage of Participants Achieving Ankylosing Spondylitis (ASAS) 40 Response at Week 12|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) in 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40% improvement from baseline and an absolute change ≥ 20 units on a 0-100 scale (0 = no disease activity, 100 = high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|Week 12|Modified intent-to-treat (mITT) population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for axial spondyloarthritis (AxSpA). Missing data were imputed through last observation carried forward (LOCF) approach.||Percentage of participants|||Number
833546|NCT01266824|Secondary|PIPP Score|PIPP score measure immediately following mydriatic drop administration|within 5 minutes after Mydriatic drop administration|Due to poor enrollment, this study was not completed and no patients were analyzed as a part of the randomized controlled trial.|||||
833547|NCT01266824|Secondary|Bradycardia/Desaturation|Number of episodes of bradycardia (HR 90) and significant desaturation (event requiring stimulation, per Neonatal Intensive Care Unit (NICU) protocol, to resolve) occurring after the administration of mydriatic and proparacaine eye drops|Within 5 minutes after Proparacaine/mydriatic drop administration until study monitor disconnected|Due to poor enrollment, this study was not completed and no patients were analyzed as a part of the randomized controlled trial.|||||
833548|NCT01266824|Secondary|PIPP Score|PIPP scores measure immediately after Proparacaine administration|within 5 minutes after Proparacaine administration|Due to poor enrollment, this study was not completed and no patients were analyzed as a part of the randomized controlled trial.|||||
833549|NCT01266824|Primary|Change in PIPP Score|Comparison of the change in Premature Infant Pain Profile (PIPP) scores from baseline to the time immediately following mydriatic drop administration between the groups of infants who do and do not receive Proparacaine eye drops prior to mydriatic drops. The PIPP score is a scale to determined pain response that was designed for use in preterm and term infants. It is based on both physiologic and behavioral changes exhibited by infants during the study period of 30s (facial changes, HR, O2 saturation). There are correction factors for gestational age and baseline state at time of scoring. Scores can range from 0-21 with the maximum score dependent on the infant's gestational age. A score >7 typically indicates a pain response while a score >12 indicates more severe pain.|Change from baseline to time immediately following mydriatic drop administration|Due to poor enrollment, this study was not completed and no patients were analyzed as a part of the randomized controlled trial.|||||
833550|NCT01266850|Secondary|Number of Participants Developing Neutralizing Rotavirus Antibody to Rotavirus Serotypes G4P8|Blood was collected from all participants at the follow up visit 3-6 weeks after the last vaccination for testing in the ELISA assay to determine the antibody titers to rotavirus serotype G4P8. A participant met the threshold of a positive response if the post vaccination antibody titer was 10 or greater.|3-6 weeks after the last dose of vaccine.|The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all scheduled study vaccinations, and who contributed post-vaccination blood samples for testing for which valid results were reported.||participants|||Number
833551|NCT01266850|Secondary|Number of Participants Developing Neutralizing Rotavirus Antibody to Rotavirus Serotype G3|Blood was collected from all participants prior to vaccination and at the follow up visit 3-6 weeks after the last vaccination for testing in the ELISA assay to determine the antibody titers to rotavirus serotype G3. A participant met the threshold of a positive response if the post vaccination antibody titer was 10 or greater.|3-6 weeks after the last dose of vaccine.|The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all scheduled study vaccinations, and who contributed post-vaccination blood samples for testing for which valid results were reported.||participants|||Number
833552|NCT01266850|Secondary|Number of Participants Developing Neutralizing Rotavirus Antibody to Rotavirus Serotypes G1, G2, G4P6 and G9|Blood was collected from all participants at the follow up visit 3-6 weeks after the last vaccination for testing in the ELISA assay to determine the antibody titers to rotavirus serotypes G1, G2, G4P6 and G9. A participant met the threshold of a positive response if the post vaccination antigen-specific antibody titer was 10 or greater.|3-6 weeks after the last dose of vaccine.|The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all scheduled study vaccinations, and who contributed post-vaccination blood samples for testing for which valid results were reported.||participants|||Number
833553|NCT01266850|Primary|Geometric Mean Serum Anti-rotavirus IgA Titer|Blood was collected from all participants at the follow up visit 3-6 weeks after the last vaccination for testing in the ELISA assay to determine the anti-rotavirus IgA antibody titers. The geometric mean titers (GMT) for each group were calculated along with the 95% confidence intervals.|3-6 weeks after the last dose of vaccine|The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all scheduled study vaccinations, and who contributed post-vaccination blood samples for testing for which valid results were reported.||titers||95% Confidence Interval|Mean
833554|NCT01266850|Secondary|Number of Participants Experiencing Hematochezia at Any Time During the Study|Hematochezia was defined as any stools that are black and tarry; maroon in color; or frank red blood. At each visit, signs of hematochezia were assessed and the participant's parent/guardian was instructed to contact the clinical site at any time if the participant had evidence of hematochezia.|Day 1 through 6 months after the last vaccination|All participants who were vaccinated are included in the analysis population.||participants|||Number
834226|NCT01275625|Secondary|Immunological Response at Week 48: Absolute Change From Baseline in Absolute Cluster of Differentiation 4 (CD4)|Immunological Response was summarized using absolute change from Baseline to Week 48 in absolute CD4+ cell count|Week 48|FAS Population included those participants who had taken at least 1 dose of the study drug.||cells/microliter (cells/mcL)||Standard Deviation|Mean
833555|NCT01266850|Secondary|Number of Participants Experiencing Solicited Systemic Reactions in the 8 Days After Vaccination|The participants' parent/guardian was given a memory aid to record for 8 days the presence of solicited reactions of fever, diarrhea and vomiting. Fever was considered experienced if the participant was assessed with an axillary temperature of 100.4F or greater on any day in the 8-day period after any vaccination. Diarrhea was considered experienced if the participant had 3 or more looser than normal stools in a day. Vomiting was considered experienced if the participant vomited 2 or more times in a day.|Days 1-8 after each vaccination|All participants who were vaccinated and had reactogenicity data reported are included in the analysis population.||participants|||Number
833556|NCT01266850|Secondary|GMT of Neutralizing Rotavirus Antibody to the Most Common Rotavirus Serotypes (G1-G4 and G9)|Blood was collected from all participants at the follow up visit 3-6 weeks after the last vaccination for testing in the neutralizing antibody assay against the most common rotavirus serotypes, G1-G4 and G9. Antigen-specific geometric mean titers (GMT) for each group were calculated along with the 95% confidence intervals.|3-6 weeks after the last dose of vaccine.|The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all scheduled study vaccinations, and who contributed post-vaccination blood samples for testing for which valid results were reported.||titers||95% Confidence Interval|Mean
833557|NCT01266850|Primary|Number of Participants Developing a Serum Anti-rotavirus Immunoglobulin (Ig) A Titer of 20 or Greater in the 89-12 IgA Assay|Blood was collected from all participants at the follow up visit 3-6 weeks after the last vaccination for testing in the ELISA 89-12 assay to determine the anti-rotavirus IgA antibody titer. A participant met the threshold of a positive response if the post vaccination anti-rotavirus IgA antibody titier was 20 or greater.|3-6 weeks after the last vaccination|The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all scheduled study vaccinations, and who contributed post-vaccination blood samples for testing for which valid results were reported.||participants|||Number
833558|NCT01266850|Primary|Number of Participants Developing a Serum Anti-rotavirus Immunoglobulin (Ig) A Titer of 20 or Greater in the WC3 IgA Assay|Blood was collected from all participants at the follow up visit 3-6 weeks after the last vaccination for testing in the ELISA assay to determine the anti-rotavirus IgA antibody titer. A participant met the threshold of a positive response if the post vaccination anti-rotavirus IgA antibody titer was 20 or greater.|3-6 weeks after the last vaccination|The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all scheduled study vaccinations, and who contributed post-vaccination blood samples for testing for which valid results were reported.||participants|||Number
833559|NCT01266876|Secondary|Absolute Change From Baseline in Lipoprotein(a) at Week 12 - On-treatment Analysis|Since the assumptions of normal distribution and equality of variances were not verified for the lipid parameter, percent changes were expressed as median (interquartile range)|From Baseline to Week 12 (LOCF)|mITT population included all randomized participants with one baseline and at least one post baseline on-treatment lipoprotein(a) value.||mg/dL||Inter-Quartile Range|Median
833560|NCT01266876|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 12 - On-treatment Analysis|Since the assumptions of normal distribution and equality of variances were not verified for the lipid parameters, percent changes were expressed as median (interquartile range)|From Baseline to Week 12 (LOCF)|mITT population included all randomized participants with one baseline and at least one post baseline on-treatment lipoprotein(a) value.||percent change||Inter-Quartile Range|Median
833561|NCT01266876|Secondary|Absolute Change in the Ratio ApoB/ApoA-1 From Baseline to Week 12 - On-treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|From Baseline to Week 12|mITT population included all randomized participants with one baseline and at least one post baseline on-treatment Apo-B and ApoA-1 value.||ratio||Standard Error|Least Squares Mean
833562|NCT01266876|Secondary|Absolute Change From Baseline in Apo-A1 at Week 12 - On-treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|From Baseline to Week 12 (LOCF)|mITT population included all randomized participants with one baseline and at least one post baseline on-treatment Apo-A1 value.||mg/dL||Standard Error|Least Squares Mean
833563|NCT01266876|Secondary|Percent Change From Baseline in Apolipoprotein - A1 (Apo-A1) at Week 12 - On-treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|From Baseline to Week 12 (LOCF)|mITT population included all randomized participants with one baseline and at least one post baseline on-treatment Apo-A1 value.||percent change||Standard Error|Least Squares Mean
833564|NCT01266876|Secondary|Absolute Change From Baseline in Apo-B at Week 12 - On-treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|From Baseline to Week 12|mITT population included all randomized participants with one baseline and at least one post baseline on-treatment Apo-B value.||mg/dL||Standard Error|Least Squares Mean
833565|NCT01266876|Secondary|Percent Change From Baseline in Apo Lipoprotein B (Apo-B) at Week 12 - On-treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|From Baseline to Week 12 (LOCF)|mITT population included all randomized participants with one baseline and at least one post baseline on-treatment Apo-B value.||percent change||Standard Error|Least Squares Mean
833566|NCT01266876|Secondary|Absolute Change From Baseline in Non-HDL-C at Week 12 - On-treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|From Baseline to Week 12 (LOCF)|mITT population included all randomized participants with one baseline and at least one post baseline on-treatment non-HDL-C value.||mg/dL||Standard Error|Least Squares Mean
833567|NCT01266876|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12 - On-treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|From Baseline to Week 12|mITT population included all randomized participants with one baseline and at least one post baseline on-treatment non-HDL-C value.||percent change||Standard Error|Least Squares Mean
833568|NCT01266876|Secondary|Absolute Change From Baseline in Triglycerides at Week at 12 - On-treatment Analysis|Since the assumptions of normal distribution and equality of variances were not verified for the lipid parameters, percent changes were expressed as median (interquartile range)|From Baseline to Week 12 (LOCF)|mITT population included all randomized participants with one baseline and at least one post baseline on-treatment fasting triglycerides value.||mg/dL||Inter-Quartile Range|Median
833572|NCT01266876|Secondary|Absolute Change From Baseline in Total Cholesterol at Week 12 - On-treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|From Baseline to Week 12 (LOCF)|mITT population included all randomized participants with one baseline and at least one post baseline on-treatment total cholesterol value.||mg/dL||Standard Error|Least Squares Mean
833573|NCT01266876|Secondary|Percent Change From Baseline in Total Cholesterol at Week 12 - On-treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|From Baseline to Week 12 (LOCF)|mITT population included all randomized participants with one baseline and at least one on-treatment total cholesterol value.||percent change||Standard Error|Least Squares Mean
833574|NCT01266876|Secondary|Percentage of Participants Achieving LDL-C < 70 mg/dL (1.81 mmol/L) at Week 12 - On-treatment Analysis|Calculated LDL-C value was obtained from Friedewald formula.|Week 12 (LOCF)|mITT population included all randomized participants with one baseline and at least one on-treatment calculated LDL-C.||percentage of participants|||Number
833575|NCT01266876|Secondary|Percentage of Participants Achieving Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 12 - On-treatment Analysis|Calculated LDL-C value was obtained from Friedewald formula.|Week 12 (LOCF)|mITT population included all randomized participants with one baseline and at least one on-treatment calculated LDL-C.||percentage of participants|||Number
833576|NCT01266876|Secondary|Absolute Change From Baseline in Calculated LDL-C at Week 12 - On-treatment Analysis|Calculated LDL-C value was obtained from Friedewald formula. Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|From Baseline to Week 12 (LOCF)|mITT population included all randomized participants with one baseline and at least one on-treatment calculated LDL-C.||mg/dL||Standard Error|Least Squares Mean
833577|NCT01266876|Primary|Percent Change From Baseline in Calculated LDL-C at Week 12 - On-treatment Analysis|Calculated LDL-C values were obtained using the Friedewald formula. Baseline adjusted least squares (LS) means and standard errors were estimated using an analysis of covariance (ANCOVA) model including available post-baseline data on treatment from first investigational medicinal product (IMP) injection up to 21 days after last IMP injection (on-treatment analysis). Missing Week 12 data were imputed by last observation carried forward [LOCF] method.|From Baseline to Week 12 (LOCF)|Modified Intent-To-Treat (mITT) population included all randomized participants with one baseline and at least one post baseline on-treatment calculated LDL-C.||percent change||Standard Error|Least Squares Mean
833578|NCT01266967|Secondary|Number of Response Genetics Incorporated (RGI) Investigational Use Only (IUO) Assay Mutation Positive Participants and THxID BRAF Assay Mutation Positive Participants With the Indicated Best Intracranial Response|The BRAF screening assay determines the specific BRAF mutational status (V600 E and K) in participants with metastatic melanoma who may benefit from treatment with GSK2118436. Per RECIST, version 1.1, CR is defined as the disappearance of all lesions. PR is defined as a >=30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline (BL) sum of the diameters (e.g., percent change from BL). Stable disease is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD is defined as a >=20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir [smallest sum of diameters recorded since treatment start]). In addition, the sum must have an absolute increase from nadir of 5 millimeters. Not evaluable: cannot be classified by a preceding definition.|Screening|V600EK and THIDEK Population: all enrolled participants who were V600E or V600K mutation positive by the RGI IUO assay||participants|||Number
833579|NCT01266967|Secondary|Composite of Pharmacokinetic Parameters of GSK2118436 in a Subset of Participants Receiving Dexamethasone|This outcome measure could not be analyzed because too few participants participated in the dexamethasone study.|Day 15||||||
833580|NCT01266967|Secondary|Median Concentrations of GSK2118436 and Its Metabolites Including GSK2285403, GSK2298683, and GSK2167542|Summary statistics were calculated for each time point by cohort. The population pharmacokinetics were determined using a non-linear mixed effects modeling approach after pooling the data with other studies. These results are reported separately.|Week 4 (pre-dose and 1-3 hours post-dose) and Weeks 8, 16, 24, and 32 (either pre-dose in the morning or in the afternoon at 4-8 hours post-dose)|PK Population: participants in the ATS population for whom a PK sample was obtained and analyzed. Only those participants whose samples were available at the indicated time points were analyzed.||nanograms per milliliter (ng/mL)||Full Range|Median
833581|NCT01266967|Secondary|Number of Participants With Abnormal Echocardiograms (ECHO) at Weeks 4 and 12|Echocardiograms (ECHO) were measured for all treated participants. An echocardiogram test gives information about the structure and function of the heart. LLN=lower limit of normal (determined by the institution).|Weeks (W) 4 and 12|ATS Population||participants|||Number
833582|NCT01266967|Secondary|Number of Participants With a Worst-case On-therapy Increase From Baseline in Bazett's QTc Reading in the 12-lead Electrocardiogram (ECG)|An increase in the QTc interval corrected using Bazett's formula (Bazett's QTc) was recorded for all treated participants. Grade 1 (450-480 milliseconds [msec]), Grade 2 (481-500 msec), Grade 3/4 (>=501 msec). An increase is defined as an increase in CTCAE grade relative to Baseline grade.|Baseline; Weeks 4, 12, 20, 28, 40, 52, and 64|ATS Population. Only those participants with data available at the indicated time points were analyzed.||participants|||Number
833583|NCT01266967|Secondary|Mean Blood Pressure at Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, and 36|Systolic and diastolic blood pressure were measured for all treated participants.|Baseline; Weeks 4, 8, 12, 16, 20, 24, 28, 32, and 36|ATS Population. Only those participants with data available at the indicated time points were analyzed.||millimeters of mercury (mmHg)||Standard Deviation|Mean
833584|NCT01266967|Secondary|Number of Participants With a Worst-case on Therapy Change to Grade 3 and Grade 4, or With Any Grade Increase (AGI), From Baseline Grade for Hematology Parameters|Hematology data were summarized at each scheduled assessment according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE, version 4.0). Grade refers to the severity of the toxicity. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on this general guideline: Grade 1, mild; Grade 2, moderate; Grade 3, severe, Grade 4, life threatening, Grade 5, death related to toxicity. Blood sample was collected for the assessment of hemoglobin, white blood cells, and platelet count.|From Screening until the conclusion of the study (up to 103 weeks)|ATS Population. Only those participants with data available for the indicated parameters were analyzed.||participants|||Number
833585|NCT01266967|Secondary|Number of Participants With the Indicated Hepatobiliary Laboratory Abnormalities|Blood samples were collected for the assessment of hepatobiliary parameters. ALT=alanine aminotranserase; AST=aspartate aminotransferase; ALP=alkaline phosphatase; BIL=total bilirubin; INR=international normalized ratio; ULN=upper limit of normal. Hepato-cellular injury is defined as (ALT/ULN)/(ALP/ULN) >=5.|From Screening until the conclusion of the study (up to 103 weeks)|ATS Population||participants|||Number
833586|NCT01266967|Secondary|Number of Participants With a Worst-case on Therapy Change to Grade 3 and Grade 4, or With Any Grade Increase (AGI), From Baseline Grade for Clinical Chemistry Parameters|Clinical chemistry data were summarized at each scheduled assessment according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE, version 4.0). Grade refers to the severity of the toxicity. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on this general guideline: Grade (G) 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life threatening; Grade 5, death related to toxicity. Blood sample was collected for the assessment of glucose, potassium, magnesium, sodium, phosphorus, potassium. aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), creatinine, total bilirubin, albumin, amylase, cholesterol, creatine kinase, gamma glutamyl transferase (GGT), lipase, blood pH, and triglycerides.|From Screening until the conclusion of the study (up to 103 weeks)|ATS Population. Only those participants with data available for the indicated parameters were analyzed.||participants|||Number
833587|NCT01266967|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury.|From Screening until the conclusion of the study (up to 103 weeks)|All Treated Subjects (ATS) Population: all participants who received at least one dose of study treatment||participants|||Number
833588|NCT01266967|Secondary|Overall Survival in V600K Mutation-positive Participants|Overall survival (OS) is defined as the time from the first dose of study medication until death due to any cause. OS was censored using the date of last known contact for those participants who were alive at the time of analysis.|Time from the first dose of study medication until death due to any cause (average of 26 weeks)|V600K Population||months||95% Confidence Interval|Median
833589|NCT01266967|Secondary|Overall Survival of V600E Mutation-positive Participants|Overall survival (OS) is defined as the time from the first dose of study medication until death due to any cause. OS was censored using the date of last known contact for those participants who were alive at the time of analysis.|Time from the first dose of study medication until death due to any cause (average of 35 weeks)|V600E Population||months||95% Confidence Interval|Median
833590|NCT01266967|Secondary|Progression-free Survival in V600K Mutation-positive Participants|PFS is defined as the time from the first dose of study medication to the earliest of death or progression (at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 millimeters (mm). If a participant received subsequent anti-cancer therapy prior to the date of documented PD/death, the participant was censored at the last adequate assessment and the visit level response was CR (disappearance of all target lesions), PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters [e.g., percent change from Baseline]), or stable disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|Time from the first dose of study medication to the earliest of death or progression (average of 17 weeks)|V600K Population||weeks||95% Confidence Interval|Median
833591|NCT01266967|Secondary|Progression-free Survival in V600E Mutation-positive Participants|PFS is defined as the time from the first dose of study medication to the earliest of death or progression (at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 millimeters (mm). If a participant received subsequent anti-cancer therapy prior to the date of documented PD/death, the participant was censored at the last adequate assessment and the visit level response was CR (disappearance of all target lesions), PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters [e.g., percent change from Baseline]), or stable disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|Time from the first dose of study medication to the earliest of death or progression (average of 23 weeks)|V600E Population||weeks||95% Confidence Interval|Median
833592|NCT01266967|Secondary|Duration of Overall Response for the Subset of V600K Mutation-positive Participants|Duration of Overall Response is defined as the time from the first documented evidence of overall CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]) until the time of the first documented disease progression (PD) or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 millimeters (mm).|Time from the first documented evidence of CR or PR until the time of the first documented disease progression or death due to any cause (average of 31 weeks)|V600K Population. Only the subset of participants who had a complete or partial response was included in this analysis.||weeks||95% Confidence Interval|Median
834369|NCT01267175|Primary|Usability of the X54 Insulin Pump Meets Expectations|Questionnaire completed at the end of the study measuring usability of the X54 insulin pump. Results scored on a Likert scale of 1 - 7, 1 being the least likely to use and 7 being the most likely to use.|5 weeks|||Scores on a scale||Standard Deviation|Mean
833593|NCT01266967|Secondary|Duration of Overall Response for the Subset of V600E Mutation-positive Participants|Duration of Overall Response is defined as the time from the first documented evidence of overall CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]) until the time of the first documented disease progression (PD) or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 millimeters (mm).|Time from the first documented evidence of CR or PR until the time of the first documented disease progression or death due to any cause (average of 28 weeks)|V600E Population. Only the subset of participants who had a complete or partial response was included in this analysis.||weeks||95% Confidence Interval|Median
833594|NCT01266967|Secondary|Duration of Intracranial Response for the Subset of V600K Mutation-positive Participants|Duration of Intracranial Response is defined as the time from the first documented evidence of intracranial CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]) until the time of the first documented intracranial disease progression (PD) or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 millimeters (mm).|Time from the first documented evidence of intracranial CR or PR until the time of the first documented intracranial disease progression or death due to any cause (average of 31 weeks)|V600K Population. Only the subset of participants who had a complete or partial intracranial response was included in this analysis.||weeks||95% Confidence Interval|Median
833595|NCT01266967|Secondary|Duration of Intracranial Response for the Subset of V600E Mutation-positive Participants|Duration of Intracranial Response is defined as the time from the first documented evidence of intracranial CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]) until the time of the first documented intracranial disease progression (PD) or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 millimeters (mm).|Time from the first documented evidence of intracranial CR or PR until the time of the first documented intracranial disease progression or death due to any cause (average of 27 weeks)|V600E Population. Only the subset of participants who had a complete or partial intracranial response was included in this analysis.||weeks||95% Confidence Interval|Median
833596|NCT01266967|Secondary|Number of Participants With V600K Mutation-positive Melanoma With OIR, as Assessed by the Investigator|OIR is defined as the number of participants whose intracranial response was a confirmed complete response (CR) or partial response (PF) assessed by investigators using modified Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. CR is defined as disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters (e.g., percent change from Baseline). For the primary analysis, OIR was measured when all participants in both treatment arms had two post-Baseline disease assessments. Participants who had an intracranial response of not evaluable or a missing response were treated as non-responders. Confirmation assessments were to be performed no less than 4 weeks after the criteria for response were initially met and may have been performed at the next protocol scheduled assessment.|From the time of the Baseline assessment until disease progression or end of study treatment (average of 16 weeks)|V600K Population||participants|||Number
833597|NCT01266967|Secondary|Number of Participants With V600K Mutation-positive Melanoma With a Best Overall Response (OR) of CR or PR, as Assessed by the Investigator|OR is defined as the number of participants achieving either a CR (the disappearance of all target lesions) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]) per modified RECIST, version 1.1. To determine the OR, the extracranial response was combined with the intracranial response. Confirmation assessments were to be performed no less than 4 weeks after the criteria for response were initially met and may have been performed at the next protocol-scheduled assessment. Participants who had an overall response of not evaluable or a missing response were treated as non-responders.|From the time of the Baseline assessment until disease progression or end of study treatment (average of 17 weeks)|V600K Population: all participants with BRAF V600K mutation-positive melanoma who received at least one dose of study treatment||participants|||Number
833598|NCT01266967|Secondary|Number of Participants With V600E Mutation-positive Melanoma With a Best Overall Response (OR) of CR or PR, as Assessed by the Investigator|OR is defined as the number of participants achieving either a CR (the disappearance of all target lesions) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]) per modified RECIST, version 1.1. To determine the OR, the extracranial response was combined with the intracranial response. Confirmation assessments were to be performed no less than 4 weeks after the criteria for response were initially met and may have been performed at the next protocol-scheduled assessment. Participants who had an overall response of not evaluable or a missing response were treated as non-responders.|From the time of the Baseline assessment until disease progression or end of study treatment (average of 24 weeks)|V600E Population||participants|||Number
833610|NCT01267045|Primary|Cognitive Failures Questionnaire|The Cognitive Failure Questionnaire is a 25-item self-report measure of cognitive difficulty during daily living in the past six months. Each item is a question indicating a situation involving a type of cognitive failure (e.g. “Do you find you forget why you went from one part of the house to another?”), and the subject indicates how often that happens to them, on a scale of 0 (never) to 4 (very often). Scores range from a minimum of 0 to a maximum of 100; the higher the score, the worse the outcome.|8 months|||units on a scale||Standard Deviation|Mean
833599|NCT01266967|Primary|Number of Participants With BRAF V600E Mutation-positive Melanoma With Overall Intracranial Response (OIR), as Assessed by the Investigator|OIR is defined as the number of participants whose intracranial response was a confirmed complete response (CR) or partial response (PR) assessed by investigators using modified Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. CR is defined as disappearance of all lesions. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters (e.g., percent change from Baseline). For the primary analysis, OIR was measured when all participants in both treatment arms had two post-Baseline disease assessments. Participants who had an intracranial response of not evaluable or a missing response were treated as non-responders. Confirmation assessments were to be performed no less than 4 weeks after the criteria for response were initially met and may have been performed at the next protocol scheduled assessment.|From the time of the Baseline assessment until disease progression or end of study treatment (average of 18.3 weeks)|V600E Population: all participants with BRAF V600E mutation-positive melanoma who received at least one dose of study treatment||participants|||Number
833600|NCT01267019|Secondary|Profile of Nonverbal Sensitivity (PONS)|"A measure of social perception. It is scored as number correct and higher is better. It ranges from 0 - 110.
Note: Two of the study arms (in vivo and social cognitive training) receive identical procedures and produce identical outcome numbers for the first 6 weeks of the study."|baseline, 6 weeks, 12 weeks, and 3 months.|||units on a scale||Standard Deviation|Mean
833601|NCT01267019|Secondary|The Awareness of Social Inference Test (TASIT)|"A measure of mentalizing (i.e., making inferences about other people). It is scored for accuracy in which higher is better. It ranges from 0 - 64.
Note: Two of the study arms (in vivo and social cognitive training) receive identical procedures and produce identical outcome numbers for the first 6 weeks of the study."|baseline, 6 weeks, 12 weeks, and 3 months.|||units on a scale||Standard Deviation|Mean
833602|NCT01267019|Primary|Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT)|"A standardized measure of emotion processing. It is scored as a standard score with a population mean of 100 and standard deviation of 15. It can range from 0 to 200. Higher is better.
Note: Two of the study arms (in vivo and social cognitive training) receive identical procedures and produce identical outcome numbers for the first 6 weeks of the study."|baseline, 6 weeks, 12 weeks, and 3 months.|||units on a scale||Standard Deviation|Mean
833603|NCT01267045|Secondary|Five Facet Mindfulness Questionnaire|The Five Facet Mindfulness Questionnaire (FFMQ) measures five aspects of mindfulness: Observing, Describing, Acting with Awareness, Non-judging, and Non-reacting. It is a 39-item self-report questionnaire. Subjects respond to each statement (e.g. “I disapprove of myself when I have irrational ideas”) by indicating how often they agree with the statement on a scale of 1 (“never or very rarely true”) to 5 (“very often or always true”). Scores range from a minimum of 39 to a maximum of 195. Higher scores indicate greater levels of mindfulness.|8 months|||units on a scale||Standard Deviation|Mean
833604|NCT01267045|Secondary|Five Facet Mindfulness Questionnaire|The Five Facet Mindfulness Questionnaire (FFMQ) measures five aspects of mindfulness: Observing, Describing, Acting with Awareness, Non-judging, and Non-reacting. It is a 39-item self-report questionnaire. Subjects respond to each statement (e.g. “I disapprove of myself when I have irrational ideas”) by indicating how often they agree with the statement on a scale of 1 (“never or very rarely true”) to 5 (“very often or always true”). Scores range from a minimum of 39 to a maximum of 195. Higher scores indicate greater levels of mindfulness.|2 months|||units on a scale||Standard Deviation|Mean
833605|NCT01267045|Secondary|PROMIS Fatigue|"The self-report PROMIS Fatigue measure uses a maximum of 7 questions to assess fatigue symptoms over the past 7 days. Subjects respond to each question (e.g. “How often did you feel tired?) with the following scale:
= never
= rarely
= sometimes
= often
= always
Raw scores are converted to T-scores, which are standardized to a mean of 50. Scores above 50 indicate higher than average fatigue; scores below 50 indicate lower than average fatigue."|8 months|||T-score||Standard Deviation|Mean
833606|NCT01267045|Secondary|PROMIS Fatigue|"The self-report PROMIS Fatigue measure uses a maximum of 7 questions to assess fatigue symptoms over the past 7 days. Subjects respond to each question (e.g. “How often did you feel tired?) with the following scale:
= never
= rarely
= sometimes
= often
= always
Raw scores are converted to T-scores, which are standardized to a mean of 50. Scores above 50 indicate higher than average fatigue; scores below 50 indicate lower than average fatigue."|2 months|||T-score||Standard Deviation|Mean
833607|NCT01267045|Secondary|PTSD Symptom Severity Interview (PSSI)|The PTSD Symptom Severity Interview (PSSI) is a 17-question interview that measures the severity of PTSD symptoms in the past month. The interviewing researcher asks the subject to respond to each question (e.g. “Have you had recurrent or intrusive distressing thoughts or recollections about the trauma?”) by indicating how often per week he or she experiences that symptom. For each item, “not at all” is scored as 0; “once per week or less/a little” is scored as 1; “2 to 4 times per week/somewhat” is scored as 2; and “5 or more times per week/very much” is scored as 3. Total scores range from a minimum of 17 to a maximum of 51; the higher the score, the worse the outcome.|8 months|||units on a scale||Standard Deviation|Mean
833608|NCT01267045|Secondary|PTSD Symptom Severity Interview (PSSI)|The PTSD Symptom Severity Interview (PSSI) is a 17-question interview that measures the severity of PTSD symptoms in the past month. The interviewing researcher asks the subject to respond to each question (e.g. “Have you had recurrent or intrusive distressing thoughts or recollections about the trauma?”) by indicating how often per week he or she experiences that symptom. For each item, “not at all” is scored as 0; “once per week or less/a little” is scored as 1; “2 to 4 times per week/somewhat” is scored as 2; and “5 or more times per week/very much” is scored as 3. Total scores range from a minimum of 17 to a maximum of 51; the higher the score, the worse the outcome.|2 months|||units on a scale||Standard Deviation|Mean
833609|NCT01267045|Secondary|Patient Health Questionnaire (PHQ-9)|The Patient Health Questionnaire (PHQ-9) is a 9-item (with an additional 10th item if any of the previous 9 are endorsed) self-report measure of depression. Subjects are instructed to indicate how often, over the last 2 weeks, they have been bothered by each problem (e.g. “feeling tired or having little energy”), from “not at all” (0), to “nearly every day” (3). Scores range from a minimum of 0 to a maximum of 30; the higher the score, the worse the outcome.|8 months|||units on a scale||Standard Deviation|Mean
834477|NCT01278927|Secondary|Nausea|Two questions using a similar format as the SF-36 were added to measure nausea. The scale ranges from 1 - 5, where a higher score indicates worse nausea.|100 days|||units on a scale||Standard Deviation|Mean
833611|NCT01267045|Primary|Cognitive Failures Questionnaire|The Cognitive Failure Questionnaire is a 25-item self-report measure of cognitive difficulty during daily living in the past six months. Each item is a question indicating a situation involving a type of cognitive failure (e.g. “Do you find you forget why you went from one part of the house to another?”), and the subject indicates how often that happens to them, on a scale of 0 (never) to 4 (very often). Scores range from a minimum of 0 to a maximum of 100; the higher the score, the worse the outcome.|2 months|||units on a scale||Standard Deviation|Mean
833612|NCT01267045|Primary|Multidimensional Fatigue Inventory - General Fatigue|"The Multidimensional Fatigue Inventory is a 20-item self-report measure of various types of fatigue. Each item is a statement, and the subject indicates how much, on a scale of 1 (yes, that is true) to 5 (no, that is not true), he or she agrees with the statement (e.g. I feel very active.) Scores range from a minimum of 20 to a maximum of 100; the higher the score, the worse the outcome."|8 months|||units on a scale||Standard Deviation|Mean
833613|NCT01267045|Primary|Multidimensional Fatigue Inventory - General Fatigue|"The Multidimensional Fatigue Inventory is a 20-item self-report measure of various types of fatigue. Each item is a statement, and the subject indicates how much, on a scale of 1 (yes, that is true) to 5 (no, that is not true), he or she agrees with the statement (e.g. I feel very active.) Scores range from a minimum of 20 to a maximum of 100; the higher the score, the worse the outcome."|2 months|||units on a scale||Standard Deviation|Mean
833614|NCT01267045|Primary|The Short-Form McGill Pain Questionnaire|The Short-Form McGill Pain Questionnaire is a self-report 22-item measure that assesses various types of pain on a scale of 0 (none) to 10 (worst possible) experienced during the past week. Score ranges from a minimum of 0 to a maximum of 220; the higher the score, the worse the outcome.|8 months|||units on a scale||Standard Deviation|Mean
833615|NCT01267045|Secondary|Patient Health Questionnaire (PHQ-9)|The Patient Health Questionnaire (PHQ-9) is a 9-item (with an additional 10th item if any of the previous 9 are endorsed) self-report measure of depression. Subjects are instructed to indicate how often, over the last 2 weeks, they have been bothered by each problem (e.g. “feeling tired or having little energy”), from “not at all” (0), to “nearly every day” (3). Scores range from a minimum of 0 to a maximum of 30; the higher the score, the worse the outcome.|2 months|||units on a scale||Standard Deviation|Mean
833616|NCT01267045|Primary|The Short-form McGill Pain Questionnaire|The Short-Form McGill Pain Questionnaire is a self-report 22-item measure that assesses various types of pain on a scale of 0 (none) to 10 (worst possible) experienced during the past week. Score ranges from a minimum of 0 to a maximum of 220; the higher the score, the worse the outcome.|2 months|||units on a scale||Standard Deviation|Mean
833617|NCT01267266|Secondary|Correlation of Molecular Profile With Clinical Outcomes|Study terminated after randomization of only 8 subjects. Correlative data not analyzed.|Up to 2 years||||||
833618|NCT01267266|Secondary|Toxicity and Incidence of Adverse Events.|Percentage of patients who discontinued therapy due to toxicity.|Up to 6 months.|||percentage of participants||95% Confidence Interval|Number
833619|NCT01267266|Secondary|Toxicity and Incidence of Adverse Events|Percentage of patients with grade 4 toxicity.|Up to 6 months.|||percentage of participants||95% Confidence Interval|Number
833620|NCT01267266|Primary|Duration of Stable Disease. (Time to Disease Progression by CT and/or Bone Scan or Clinical Progression.)|Time to progression will be assessed using the Kaplan-Meier method and compared between groups via Wilcoxon rank-sum test.|Up to 6 months.|Two patients in the placebo arm censored at 12 and 17 weeks, respectively.||weeks||Full Range|Median
833621|NCT01267292|Secondary|Reversal Learning as Assessed by Number of Perseverative Errors on the Reversal Learning Task|The task is a rapid-presentation, probablistic gain/loss design. Reversal learning is assessed by means of a simple computerized card game. The paradigm utilizes a visual discrimination task where subjects have to learn to respond to outcome contingencies between two stimuli (high probability gain/low probability loss vs. low probability gain/high probability loss). At an unsignaled time point halfway into testing, the contingencies are reversed; the losing card becomes the winning card and the winning card becomes the losing one. Visual feedback regarding win or loss ($0.20) is provided after each trial and the cumulative total gained/lost is also shown. Using trial-and-error feedback, subjects have to discover which of the two patterns is correct and are instructed to win as much money as possible. The duration of the task is approximately 10 minutes, consisting of 80 trials.|Monday of week 4|||number of perseverative errors||Standard Deviation|Mean
833622|NCT01267292|Secondary|Reversal Learning as Assessed by Number of Perseverative Errors on the Reversal Learning Task|The task is a rapid-presentation, probablistic gain/loss design. Reversal learning is assessed by means of a simple computerized card game. The paradigm utilizes a visual discrimination task where subjects have to learn to respond to outcome contingencies between two stimuli (high probability gain/low probability loss vs. low probability gain/high probability loss). At an unsignaled time point halfway into testing, the contingencies are reversed; the losing card becomes the winning card and the winning card becomes the losing one. Visual feedback regarding win or loss ($0.20) is provided after each trial and the cumulative total gained/lost is also shown. Using trial-and-error feedback, subjects have to discover which of the two patterns is correct and are instructed to win as much money as possible. The duration of the task is approximately 10 minutes, consisting of 80 trials.|Thursday of week 1|||number of perseverative errors||Standard Deviation|Mean
833623|NCT01267292|Secondary|Reversal Learning as Assessed by Number of Perseverative Errors on the Reversal Learning Task|The task is a rapid-presentation, probablistic gain/loss design. Reversal learning is assessed by means of a simple computerized card game. The paradigm utilizes a visual discrimination task where subjects have to learn to respond to outcome contingencies between two stimuli (high probability gain/low probability loss vs. low probability gain/high probability loss). At an unsignaled time point halfway into testing, the contingencies are reversed; the losing card becomes the winning card and the winning card becomes the losing one. Visual feedback regarding win or loss ($0.20) is provided after each trial and the cumulative total gained/lost is also shown. Using trial-and-error feedback, subjects have to discover which of the two patterns is correct and are instructed to win as much money as possible. The duration of the task is approximately 10 minutes, consisting of 80 trials.|baseline|||number of perseverative errors||Standard Deviation|Mean
834418|NCT01278030|Primary|Responder Rate|The responder rate is defined as the proportion of patients with reduction in end systolic volume greater than or equal to 15%. The primary endpoint is the responder rate.|At 6 month follow-up|Patients who completed the 6 month follow-up with implant 3D echo data.||percentage of participants|||Number
833624|NCT01267292|Secondary|Rapid Response Inhibition as Assessed by the Immediate Memory Task (IMT)|"Subjects are required to respond selectively to a series of stimuli (e.g., numbers) presented briefly for 500 ms with a 500 ms intertrial interval (ITI). Increases in false alarm rates are interpreted as failures in response inhibition. Five digit numbers are presented on a computer screen every 500 ms sec. Subjects are instructed to respond when the first number of a set was repeated. A hit response is scored when a subject correctly responds. Distracters consist of five-digit numbers that are completely different from the first, and numbers in which four of the five digits match the original, with the non-matching number occurring randomly across the five digit places. A response to the number with 4 of 5 digits correct is scored as a false alarm. The a-prime value reflects the ability of the participant to discriminate between signal (Go stimulus) and noise (No-Go stimulus) and ranges from 0.5 (chance level) to 1 (perfect discrimination)."|Monday of week 4|||a-prime||Standard Deviation|Mean
833625|NCT01267292|Secondary|Rapid Response Inhibition as Assessed by the Immediate Memory Task (IMT)|"Subjects are required to respond selectively to a series of stimuli (e.g., numbers) presented briefly for 500 ms with a 500 ms intertrial interval (ITI). Increases in false alarm rates are interpreted as failures in response inhibition. Five digit numbers are presented on a computer screen every 500 ms sec. Subjects are instructed to respond when the first number of a set was repeated. A hit response is scored when a subject correctly responds. Distracters consist of five-digit numbers that are completely different from the first, and numbers in which four of the five digits match the original, with the non-matching number occurring randomly across the five digit places. A response to the number with 4 of 5 digits correct is scored as a false alarm. The a-prime value reflects the ability of the participant to discriminate between signal (Go stimulus) and noise (No-Go stimulus) and ranges from 0.5 (chance level) to 1 (perfect discrimination)."|Thursday of week 1|||a-prime||Standard Deviation|Mean
833626|NCT01267292|Secondary|Rapid Response Inhibition as Assessed by the Immediate Memory Task (IMT)|"Subjects are required to respond selectively to a series of stimuli (e.g., numbers) presented briefly for 500 ms with a 500 ms intertrial interval (ITI). Increases in false alarm rates are interpreted as failures in response inhibition. Five digit numbers are presented on a computer screen every 500 ms sec. Subjects are instructed to respond when the first number of a set was repeated. A hit response is scored when a subject correctly responds. Distracters consist of five-digit numbers that are completely different from the first, and numbers in which four of the five digits match the original, with the non-matching number occurring randomly across the five digit places. A response to the number with 4 of 5 digits correct is scored as a false alarm. The a-prime value reflects the ability of the participant to discriminate between signal (Go stimulus) and noise (No-Go stimulus) and ranges from 0.5 (chance level) to 1 (perfect discrimination)."|baseline|||a-prime||Standard Deviation|Mean
833627|NCT01267292|Secondary|Diastolic Blood Pressure|"The mean score over all 44 time points is reported in this outcome measure (i.e., the summary score is reported). Each subject contributed 11 data points for each dose level of Methylphenidate (15mg, 30mg, 60mg, or 0mg), resulting in a total of 220 data points per dose level per arm.
Diastolic blood pressure is the blood pressure when the heart muscle is between beats."|11 times a day on Wednesday and Friday of week 2; 11 times a day on Monday and Wednesday of week 3|||mmHg||Standard Deviation|Mean
833628|NCT01267292|Secondary|Systolic Blood Pressure|"The mean score over all 44 time points is reported in this outcome measure (i.e., the summary score is reported). Each subject contributed 11 data points for each dose level of Methylphenidate (15mg, 30mg, 60mg, or 0mg), resulting in a total of 220 data points per dose level per arm.
Systolic blood pressure is the amount of pressure in the arteries during contraction of the heart muscle."|11 times a day on Wednesday and Friday of week 2; 11 times a day on Monday and Wednesday of week 3|||mmHg||Standard Deviation|Mean
833629|NCT01267292|Secondary|Heart Rate|"The mean score over all 44 time points is reported in this outcome measure (i.e., the summary score is reported). Each subject contributed 11 data points for each dose level of Methylphenidate (15mg, 30mg, 60mg, or 0mg), resulting in a total of 220 data points per dose level per arm.
Heart rate is the measure of heart beats per minute."|11 times a day on Wednesday and Friday of week 2; 11 times a day on Monday and Wednesday of week 3|||beats per minute||Standard Deviation|Mean
833630|NCT01267292|Secondary|"Subjective Effects as Assessed by the Elated Subscale of the Visual Analogue Scale (VAS)"|"The mean score over all 44 time points is reported in this outcome measure (i.e., the summary score is reported). Each subject contributed 11 data points for each dose level of Methylphenidate (15mg, 30mg, 60mg, or 0mg), resulting in a total of 220 data points per dose level per arm.
The VAS presents 100-mm horizontal lines labeled with an adjective: “stimulated,” “high,” “anxious,” “elated,” “hungry,” and “nauseated.” The elated subscale is reported, and this sub scale is anchored by “not at all” (0) on the left and “extremely” (100) on the right, with a score range of 0-100. The higher the score, the worse the outcome."|11 times a day on Wednesday and Friday of week 2; 11 times a day on Monday and Wednesday of week 3|||units on a scale||Standard Deviation|Mean
833631|NCT01267292|Secondary|"Subjective Effects as Assessed by Score on the Feel High Subscale of the Drug Effects Questionnaire (DEQ)"|"The mean score over all 44 time points is reported in this outcome measure (i.e., the summary score is reported). Each subject contributed 11 data points for each dose level of Methylphenidate (15mg, 30mg, 60mg, or 0mg), resulting in a total of 220 data points per dose level per arm.
The DEQ is a visual analog scale questionnaire that assesses the extent to which subjects experience four subjective states: “Feel Drug,” “Feel High,” “Like Drug,” and “Want More.” The Feel High subscale is reported, and this subscale is scored on a visual analogue scale (scroll bar on computer screen) ranging from 0-100. 100 represents the highest score for that subjective state, and the higher the score, the worse the outcome."|11 times a day on Wednesday and Friday of week 2; 11 times a day on Monday and Wednesday of week 3|||units on a scale||Standard Deviation|Mean
833646|NCT01268098|Secondary|The Percentage of Subjects Who Met the Triple Efficacy Endpoint Criteria at Week 8.|The triple efficacy endpoint criteria were defined as at least a 50% reduction from the baseline in oral calcium dose and at least a 50% reduction from the baseline in active vitamin D dose and an albumin-corrected total serum calcium concentration that was maintained or normalized compared to the baseline value (≥ 7.5 mg/dL) and did not exceed the upper limit of the laboratory normal range. The analysis of primary efficacy endpoint was based on investigator prescribed data|8 Weeks|Intent to Treat (ITT) population, which includes all randomized subjects who received at least 1 dose of study drug and had at least 1 post-baseline efficacy assessment.||percentage of participants||95% Confidence Interval|Number
833632|NCT01267292|Secondary|Subjective Effects as Assessed by Score on the Vigor Subscale of the Profile of Mood States (POMS)|"The mean score over all 44 time points is reported in this outcome measure (i.e., the summary score is reported). Each subject contributed 11 data points for each dose level of Methylphenidate (15mg, 30mg, 60mg, or 0mg), resulting in a total of 220 data points per dose level per arm.
The POMS is a self-rating measure of current mood, consisting of six subscales demonstrated to be sensitive to a range of acute drug effects, including amphetamine, cocaine, and caffeine. The six subscales are: depression, vigor, confusion, tension, anxiety, and fatigue. A 37-item short form of the POMS was used, which correlates highly with the full scale. The vigor subscale is reported, and the vigor subscale score ranges from 0 to 28, with 28 representing the highest score for that mood state. The higher the value, the worse the outcome."|11 times a day on Wednesday and Friday of week 2; 11 times a day on Monday and Wednesday of week 3|||units on a scale||Standard Deviation|Mean
833633|NCT01267292|Secondary|Subjective Effects as Assessed by the Addiction Research Center Inventory (ARCI)|The ARCI short form will be used. It is a 49-item true / false questionnaire that has been empirically-derived to assess five different factors, including euphoria, sedation, and dysphoria. The PCAG scale has proven to be a sensitive measure of subjective effects in many studies administering stimulant drugs.|11 times a day on Wednesday and Friday of week 2; 11 times a day on Monday and Wednesday of week 3|ARCI data were not collected.|||||
833634|NCT01267292|Primary|Risky Decision Making as Assessed by Score on the Risky Decision Making Task|"The mean score over all 4 time points is reported in this outcome measure (i.e., a summary score is reported). Each subject contributed 1 data point for each dose level of Methylphenidate (15mg, 30mg, 60mg, or 0mg), resulting in a total of 20 data points per dose level per arm.
The risky decision making task provides subjects with three choice options on each of 100 repeated trials. Options are low, moderate, and high risk, based on variance and probability in gain/loss amounts. The low risk option is more adaptive over many trials. The outcome measure is a risk index (ranging from 0.33 to 100) that factors in tolerance for variability and amount of gains and losses across the three options. 100 is highest risk. 0.33 is lowest risk."|1 time a day on Wednesday and Friday of week 2; 1 time a day on Monday and Wednesday of week 3|||units on a scale||Standard Deviation|Mean
833635|NCT01267292|Primary|Attentional Bias as Assessed by Score on the Stroop Task|"The mean score over all 4 time points is reported in this outcome measure (i.e., a summary score is reported). Each subject contributed 1 data point for each dose level of Methylphenidate (15mg, 30mg, 60mg, or 0mg), resulting in a total of 20 data points per dose level per arm.
The Stroop task assesses attentional biases to cocaine-related (drug-related) and rewarding (non-drug related) stimuli vs. neutral stimuli. Participants are instructed to respond to words shown in different colors on the screen, by pressing as quickly and accurately as possible on one of three colored buttons. Attentional bias is measured as the difference in reaction times on cocaine vs. neutral words. The reported score is a difference score in milliseconds (cocaine minus neutral), in which positive means slower to respond to cocaine and thus greater attentional bias, and negative means no attentional bias to cocaine words."|1 time a day on Wednesday and Friday of week 2; 1 time a day on Monday and Wednesday of week 3|||milliseconds||Standard Deviation|Mean
833636|NCT01267422|Secondary|Computerized Visual Field(VFI: Visual Field Index ,the Value Close to 100% Regarded Normal)|VFI: visual field index ,the value Close to 100% regarded normal. VFI/MD：The bigger one was more close to the normal value.|up to 3 years|Patient 2 refused the vision field test,there are VFI outcome measure of 8 patients.||Percentage of normal||Standard Deviation|Mean
833637|NCT01267422|Secondary|Computerized Visual Field(MD: Mean Deviation, the Value Close to 0 Regarded Normal)|MD: mean deviation, the value Close to 0 regarded normal.VFI/MD：The bigger one was more close to the normal value.|up to 3 years|Patient 2 refused the vision field test,there are MD outcome measure of 8 patients.||dB||Standard Deviation|Mean
833638|NCT01267422|Secondary|Average RNFL Thickness Througth Optical Coherence Tomography(OCT) Test|Average RNFL thickness of 8 patients througth Optical coherence tomography(OCT) test before and after treatment|Up to 3 years|RNFL thickness of 8 patients except Patient 1 because he once accepted the other eye's treatment||Micrometer||Standard Deviation|Mean
833639|NCT01267422|Secondary|Neutralizing Antibody Assay|The mean of Neutralizing antibody assay of 8 patients before and after treatment|up to 3 years|Neutralizing antibody assay of 8 patients except Patient 1 because he once accepted the other eye's treatment||titer||Standard Deviation|Mean
833640|NCT01267422|Secondary|Intraocular Pressure;||Up to 3 years|||mmHg||Full Range|Mean
833641|NCT01267422|Primary|Results of CD3/CD4/CD8 Test|The mean percentage of CD3+/CD4+/CD8+ test before and after treatment|up to 6 months|||Percentage of total cells||Full Range|Mean
833642|NCT01267422|Primary|The Best Corrected Visual Acuity(BCVA)||Up to 3 years|The data are expressed as mean±standard error. Comparisons before and after treatment of the BCVA were analyzed using the paired t-test.A probability (P) value of less than 0.05 was considered statistically significant.Lower logMAR represents a better outcome.||logMAR|Participants|Standard Error|Mean
833643|NCT01267929|Primary|The Gross Motor Function Measure (GMFM-66) Score at Entry, the Second and the Sixth Month.|The mean total score of GMFM-66 of each group at entry, the second and the sixth month. The GMFM-66 contains five dimensions of motor measure including lying/rolling (4 items), sitting (15 items), crawling/kneeling (10 items), standing (13 items), and walking/running/jumping (24 items). The GMFM-66 are scored on a 4-point ordinal scale 0=does not initiate, 1=initiates < 10% of activity,2=partially completes 10% to < 100% of activity,3=completes activity). The scores were converted to a continuous scale by using the Winsteps Rasch Software.The GMFM-66 score is an interval-level measure of function where subjects are placed on an ability continuum ranging from 0 (low motor ability) to 100 (high motor ability). GMFM-66 score less than 30 that are considered low gross motor skills.|Base line, two months and six months|A total of 30 children with cerebral palsy was followed and completed the study.||Scores on a scale||Standard Deviation|Mean
833644|NCT01267994|Secondary|To Assess the Safety and Tolerability of a Three Month (84 Day) Course of Anakinra in Corticosteroid Resistant Patients With Autoimmune Inner Ear Disease.||84 days||||||
833645|NCT01267994|Primary|To Assess the Potential Efficacy of Anakinra in Improving Hearing Thresholds in Corticosteroid-resistant Patients With Autoimmune Inner Ear Disease|The primary endpoint is to determine whether those treated with anakinra for 84 days demonstrate an improved hearing threshold compared with their pre-anakinra-treatment threshold. Audiometric thresholds will be compared to those treated with a prolonged corticosteroid taper and those that elect for no further treatment. The durability of the response will be measured over a total of 180 days.|180 days|||responders|||Number
833647|NCT01268098|Primary|Percentage of Subjects Who Achieved the Primary Triple Endpoint at Week 8, Based on Investigator Prescribed Data.|The triple efficacy endpoint criteria were defined as a reduction from baseline in oral calcium to ≤ 500 mg/day, a reduction from baseline in calcitriol dose to ≤ 0.25 µg/day, and an albumin-corrected total serum calcium level between 7.5 mg/dL and the upper limit of the laboratory normal range. The analysis of primary endpoint was based on investigator prescribed data.|8 Weeks|Intent to Treat (ITT) population, which includes all randomized subjects who received at least 1 dose of study drug and had at least 1 post-baseline efficacy assessment.||percentage of participants||95% Confidence Interval|Number
833648|NCT01268111|Primary|M Value (Insulin Stimulated Glucose Uptake)|Insulin stimulated glucose uptake will be measured by glucose clamp studies|Baseline and at 8 weeks|||mg/kg.min||Standard Deviation|Mean
833649|NCT01268150|Other Pre-specified|To Assess the Incidence of Adverse Events (AEs) of Eribulin Mesylate|Treatment-emergent adverse events (TEAEs) were defined as AEs that emerged during treatment, having been absent at pretreatment, and occurring within 30 days of the last dose of study treatment, or if they were present prior to the first dose administration and increased in severity during the study. For each AE a participant with two or more TEAEs in that category were counted only once. TEAEs were considered related if the relationship of the event to study drug was possibly or probably related. Serious adverse events (SAEs) were defined as any untoward medical experience that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, persistent or significant disability/incapacity, or was a congenital anomaly/birth defect. Safety information will be summarized with adverse events. AEs were graded on a five-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.|Baseline until End of Treatment (within 21 days of last dose), assessed up to the data cutoff date (30 Aug 2013) up to 2.5 years|Safety Analysis Set population included all participants who received at least one dose of study drug and had at least one postbaseline safety assessment.||Percentage of participants|||Number
833650|NCT01268150|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time from the date of the first dose of study drug until the date of first documentation of PD or date of death from any cause, whichever occurred first. Participants who died without reported PD were considered to have progressed on the day of their death. Participants who were lost to follow-up or alive and without reported PD at the end of study were censored on the date of their last tumor assessment. Participants without evidence of PD upon discontinuation of study drug during the Extension Phase returned to the clinic for disease evaluation and PFS calculation every 12 weeks until PD was documented. PFS was analyzed using Kaplan-Meier product-limit estimates. This statistical analysis method measures the effect of study drug on PFS.|Treatment Phase (Day 1 Cycle 1) to date of progressive disease or death, whichever occurred first, assessed up to the data cutoff date (30 Aug 2013) up to 2.5 years|Full analysis set included all participants who received at least one dose of eribulin mesylate.||Months||95% Confidence Interval|Median
833651|NCT01268150|Secondary|Duration of Response|Duration of response was measured for participants who were responders only, had attained a BOR that was CR or PR. The duration of response was measured from time that response criteria for CR or PR (whichever was recorded first) were first met until the date that progressive disease (PD) or death from any cause was first objectively documented. Participants who did not have PD were censored on the day of their last tumor assessment. Duration of response was summarized for the responders using Kaplan-Meier estimation method. This statistical analysis method measures the effect of study drug on the length of response time.|First date of CR or PR to PD or Death from any cause, assessed up to the data cutoff date (30 Aug 2013) up to 2.5 years|Full analysis set included all participants who received at least one dose of eribulin mesylate and were determined to be responders (CR or PR) to study treatment.||Months||95% Confidence Interval|Median
833652|NCT01268150|Secondary|Time to First Response (CR or PR)|Time to first response was defined for participants whose BOR was a CR or PR. Analysis was based on the Kaplan-Meier estimated number of months to CR or PR. This statistical analysis method measures the effect of study drug on CR or PR.|Treatment Phase (Day 1 Cycle 1) to earliest date of confirmed objective response (CR or PR), assessed up to the data cutoff date (30 Aug 2013) up to 2.5 years|Full analysis set included all participants who received at least one dose of eribulin mesylate and were determined to be responders (CR or PR) to study treatment.||Months||95% Confidence Interval|Median
833653|NCT01268150|Primary|Objective Response Rate (ORR)|The ORR was defined as the percentage of participants with best overall response (BOR) of confirmed complete response (CR) or partial response (PR), based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Targeted lesions were assessed by computed tomography (CT) and magnetic resonance imaging (MRI) which were then assessed by the investigator based on RECIST. CR was defined as the disappearance of all target lesions. PR was defined as at least 30% decrease in the sum of diameters of target lesions, taking as reference baseline sum diameters. Possible CR and PR had to be confirmed no fewer than 4 weeks after the initial response assessment. A brain and bone scan was performed by CT/MRI within 1 week after confirmation of a response to ensure no new metastases. To be assigned a status of CR or PR, changes in tumor measurements had to be confirmed by repeat evaluations, to be performed not fewer than 4 weeks after the response criteria were first met. ORR = CR + PR|Cycle 1 (Day 1) until first evidence of disease progression, assessed up to the data cutoff date (30 Aug 2013) up to 2.5 years|Full analysis set included all participants who received at least one dose of eribulin mesylate.||Percentage of participants|||Number
833654|NCT01268189|Secondary|Patient Will be Asked to Rate Pain 0-10/10 at the Study Site and the Control Site||Post-Operative Day 12|||units on a scale||Standard Deviation|Mean
833655|NCT01268189|Secondary|Patient Will be Asked to Rate Pain 0-10/10 at the Study Site and the Control Site||Post-Operative Day 10|||units on a scale||Standard Deviation|Mean
833656|NCT01268189|Secondary|Patient Will be Asked to Rate Pain 0-10/10 at the Study Site and the Control Site||Post-Operative Day 8|||units on a scale||Standard Deviation|Mean
833657|NCT01268189|Secondary|Pain Perceived by Patient|Patient will be asked to rate pain 0-10 (0=no pain, 10=maximum pain) at the study site and the control site. Used Visual Analogue Scale (VAS) for this purpose.|Post-Operative Day 4|||units on a scale||Standard Deviation|Mean
833658|NCT01268189|Primary|Healing Time for Donor Site Wounds|Wounds are inspected on postoperative days 4, 8, and then every two days until the wound is deemed to be healed.|number of days to healing|||days||Standard Deviation|Mean
833659|NCT01268267|Secondary|Numbers of Forearm Blood Glucose (BG) Results Within +/- 5 to 20 mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method|Subjects with diabetes used an investigational blood glucose monitoring system (BGMS) with subject capillary blood obtained from the forearm. BGM results were compared to a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were used to calculate the number of BG results within +/- 5 to 20 mg/dL (for reference BG results <75mg/dL) or +/- 5% to 20% (for reference BG results >=75mg/dL) of the reference method results.|2 hours|Since forearm testing by 5 hypoglycemic subjects (low blood glucose) was not allowed per the protocol, forearm data were not obtained/not evaluable for these subjects. Of the remaining 85 subjects, 83 tested 2 test strip lots(83x2) and 2 subjects tested 1 strip lot(2x1). A total of 168(166+2)test results were available.||Number of BG test results|Participants||Number
833660|NCT01268267|Secondary|Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Comprehension)|Subjects reviewed the instructions for use (User Guide and Quick Reference Guide) to learn to use the system. Study staff then observed and rated the subjects (1 to 4) on their success at performing the tasks. Scale: 1.Success in performing tasks correctly without assistance. 2.Successful with additional review of User Guide. 3.Successful with additional review and study staff assist similar to review of a specific function during a Customer Service call. 4.Subject did not perform task correctly and study staff intervention was required.|2 hours|For alternate-site palm and forearm testing tasks, 3 subjects with nonevaluable blood glucose data were not included. Only 90 participants were rated for those particular tasks.||participants|||Number
833661|NCT01268267|Secondary|Numbers of Palm Blood Glucose (BG) Results Within +/- 5 to 20 mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method|Subjects with diabetes used an investigational blood glucose monitoring system (BGMS) with subject capillary blood obtained from the palm. BGM results were compared to a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were used to calculate the number of BG results within +/- 5 to 20 mg/dL (for reference BG results <75mg/dL) or +/- 5% to 20% (for reference BG results >=75mg/dL) of the reference method results.|2 hours|Five subjects were hypoglycemic (low blood glucose value). Since alternate-site palm testing by these subjects was not allowed in the study, palm data from these five subjects were not obtained/ not evaluable. The remaining 85 subjects tested 2 test strip lots on the BGM system. 2x85(170)test results were available.||Number of BG test results|Participants||Number
833662|NCT01268267|Primary|Numbers of Fingerstick Blood Glucose (BG) Results Within +/- 5 to 20mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method|Subjects with diabetes tested subject fingerstick blood using an investigational blood glucose monitoring system (BGMS), which included an investigational meter and sensor. BGM results were compared to a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were used to calculate the number of BG results within +/- 5 to 20 mg/dL (for reference BG results <75mg/dL) or +/- 5 to 20% (for reference BG results >=75mg/dL) of the reference method results.|2 hours|One subject was withdrawn from the study. One subject YSI reference sample was misidentified. Two subjects were not in steady state, required for the study. Four subjects' blood test data were thus not evaluable. The remaining 90 subjects tested 2 test strip lots on the BGMsystem. 2x90(180) test results were available.||Number of BG test results|Participants||Number
833663|NCT01268293|Primary|Number of Participants With Adverse Events|Treatment emergent adverse events (AEs) and serious adverse events (SAEs) were evaluated by determining the AE grade according to Common Terminology Criteria for Adverse Events [CTCAE] version 4.0, laboratory tests, vital signs (blood pressure [mm Hg], heart rate [beats per minute], body temperature [degree C], and body weight [kg]), 12-lead electrocardiograms (ECGs; heart rate [bpm], QT [msec] and QTc [msec]) and Eastern Cooperative Oncology Group performance status (ECOG-PS).|Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).|The Safety Analysis Set consisted of subjects who had received at least 1 dose of study drug and had at least 1 postdose safety assessment.||Participants|||Number
833664|NCT01268293|Primary|Number of Participants With Dose Limiting Toxicity (DLT)||Up to 4 weeks|Subjects with less than 75% compliance in Cycle 1 for reasons other than the toxicity of the study drug and who discontinued prior to confirmation of tolerability in Cycle 1 were excluded from the analysis of DLT. All 9 participants completed Cycle 1 (DLT monitoring period) and were included in the analysis of DLT.||Participants|||Number
833665|NCT01268306|Primary|Number of Participants Wiith Corneal Staining|The number of participants who have disturbance of their corneal epithelium visualized by using applied sodium fluorescein solution (as a disclosing agent) evaluated by slit lamp biomicroscopy. Clinically significant staining is described as sufficiently diffuse and deep to pose potential risk of infection by the examiners assessment.|2-4 hours after contact lens insertion|Subjects who returned for examination post-challenge in the allotted time and who had observable corneal staining on slit lamp examination||participants|||Number
833666|NCT01268488|Secondary|Numbers of Forearm Blood Glucose (BG) Results Within +/- 5 to 15 mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method|Subjects with diabetes used an investigational blood glucose meter (BGM) with subject capillary blood obtained from the forearm. BGM results were compared to a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were used to calculate the number of BG results within +/- 5 to 15 mg/dL (for reference BG results <75mg/dL) or +/- 5% to 20% (for reference BG results >=75mg/dL) of the reference method results.|2 hours|158 BG results-78 subjects tested 2 strip lots;2 subjects tested 1 strip lot. 7 subjects-Low BG results disallowed forearm testing per protocol. 1 subject-Missing data. Remainder same as 'palm' analysis population description.||Number of BG Test Results|Participants||Number
833667|NCT01268488|Secondary|Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Comprehension)|Subjects reviewed the instructions for use (User Guide and Quick Reference Guide) to learn to use the system. Study staff then observed and rated the subjects(1 to 4) on their success at performing the tasks. Scale: 1.Success in performing tasks correctly without assistance. 2.Successful with additional review of User Guide. 3.Successful with additional review and study staff assist similar to review of a specific function during a Customer Service call. 4.Subject did not perform task correctly and study staff intervention was required.|2 hours|97 participants analyzed: one subject was found not to meet inclusion/exclusion criteria so subject was withdrawn and no data from this subject was evaluated. For palm and forearm testing tasks, 2 additional subjects (with nonevaluable BG data) were not included. Only 95 participants were rated for those particular tasks.||participants|||Number
833668|NCT01268488|Secondary|Numbers of Palm Blood Glucose (BG) Results Within +/- 5 to 15 mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method|Subjects with diabetes used an investigational blood glucose meter (BGM) with subject capillary blood obtained from the palm. BGM results were compared to a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were used to calculate the number of BG results within +/- 5 to 15 mg/dL (for reference BG results <75mg/dL) or +/- 5% to 20% (for reference BG results >=75mg/dL) of the reference method results.|2 hours|161 BG results-80 subjects tested 2 strip lots;1 subject had 1 reading. Withdrawn by PI- 3 subject Adverse Events before performance testing;1 subject did not meet inclusion/exclusion. 6 subjects- Data not evaluable:exceeded time between meter testing and reference method. 7 subjects-Low bg results disallowed palm testing per protocol.||Number of BG Test Results|Participants||Number
833669|NCT01268488|Primary|Numbers of Fingerstick Blood Glucose (BG) Results Within +/- 5 to 15mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method|Subjects with diabetes tested subject fingerstick blood using an investigational blood glucose meter (BGM). BGM results were compared to a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were used to calculate the number of BG results within +/- 5 to 15 mg/dL (for reference BG results <75mg/dL) or +/- 5 to 20% (for reference BG results >=75mg/dL) of the reference method results.|2 hours|178 BG results possible-88 subjects tested 2 strip lots(88x2)/2 subjects had 1 reading(2x1). Withdrawn by Principal Investigator(PI)-3 subjects experienced Adverse Events before performance testing / one subject did not meet inclusion/exclusion. Data from 4 subjects were not evaluable since exceeded time between meter testing and reference method.||Number of BG Test Results|Participants||Number
833670|NCT01268501|Primary|Overall Convenience With Contact Lenses|"Overall convenience with contact lenses, as interpreted by the participant and reported on a questionnaire as a single, retrospective evaluation of 3 weeks of wear time. Overall convenience is measured on a 4-point scale: 1=very satisfied; 2=satisfied; 3=dissatisfied; 4=very dissatisfied. Results were reported as a percentage of participants who responded, very satisfied or satisfied."|3 weeks of wear|Per Protocol. Two participants were excluded from analysis due to major protocol deviations as determined by masked review.||Percentage of participants||95% Confidence Interval|Number
833671|NCT01268553|Secondary|N-terminal Pro BNP Level|N-terminal pro BNP level|12 weeks|||pg/mL||Standard Deviation|Mean
833672|NCT01268553|Secondary|CAMPHOR: Cambridge Pulmonary Hypertension Outcome Review; Construct = Quality of Life|The Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) is a disease specific patient-reported outcome measure which assesses quality of life of patients with pulmonary hypertension (PH). QoL scores (total) range from 0-25, with higher scores indicating worse quality of life|12 q=weeks|||units on a scale||Standard Deviation|Mean
833673|NCT01268553|Secondary|VE/VCO|Ventilatory efficiency measured with cardiopulmonary exercise testing|12 weeks|||ratio||Standard Deviation|Mean
833674|NCT01268553|Secondary|Change in 6-minute Walk Distance|Change in 6-minute walk distance from baseline to 12 weeks.|12 weeks|Mean change in 6-minute walk distance||meters||Standard Deviation|Mean
833675|NCT01268553|Secondary|Number of Participants Without Clinical Worsening|"Clinical worsening is defined as any of the following:
All-cause mortality
Nonelective hospital stay for PAH (with predefined criteria, usually for initiation of intravenous prostanoids, lung transplantation, or septostomy)
Disease progression defined as a reduction from baseline in the 6MW test by 15%, confirmed by 2 studies done within 2 weeks plus worsening functional class"|12 weeks|Patients weaned off of their parenteral prostanoids without Clinical Worsening||Participants|||Count of Participants
833676|NCT01268553|Primary|Number of Participants Without Adverse Events|The number of adverse events will be recorded at transition, 4 weeks, and 12 weeks.|12 Weeks|Number of patients weaned off of their parenteral prostanoids without adverse events||Participants|||Count of Participants
833677|NCT01268566|Secondary|Treatment-emergent Adverse Events Related to Vital Sign Parameters|Vital sign assessments were conducted throughout the study and included body temperature, blood pressure (seated), pulse rate and respiratory rate. The TEAEs related to vital signs in participants were reported. Participants were counted only once for each system organ class and preferred term, regardless of how many events the participants had.|Baseline to last record on study, up to 21 months|Safety population||Participants|||Number
833678|NCT01268566|Secondary|Treatment-emergent Adverse Events Related to Electrocardiogram Evaluations|All 12-lead electrocardiograms (ECGs) performed during the study were obtained in triplicate (ie, 3 ECGs were obtained within a 5-minute time period) and analyzed. Number of participants with TEAEs related to ECG after the start of study drug administration were reported. Participants were counted only once for each system organ class and preferred term, regardless of how many events the participants had.|Baseline to last record on study, up to 21 months|Safety population||Participants|||Number
833679|NCT01268566|Secondary|Treatment-emergent Adverse Events Related to Laboratory Parameters|Laboratory evaluations of blood and urine samples were performed, including hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count with differential); serum chemistry (calcium, chloride, magnesium, potassium, sodium, aspartate transaminase, alanine transaminase, alkaline phosphatase, gamma glutamyl transferase, lactic dehydrogenase, carbon dioxide/bicarbonate, blood urea nitrogen, uric acid, creatinine, total bilirubin, glucose, albumin, total protein, triglycerides, cholesterol, phosphorous); urinalysis (pH, protein, blood, glucose, ketones, bilirubin); and coagulation parameters. Abnormal laboratory finding that required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation, was reported as an AE. Number of participants with TEAEs related to laboratory evaluations were reported.|Baseline to last record on study, up to 21 months|Safety population||Participants|||Number
833680|NCT01268566|Secondary|Number of Participants With Worst ECOG Performance Status On-study and Last Record On-study|Eastern Cooperative Oncology Group (ECOG) performance status is a scale that measures how cancer affects the daily life of a participant on an ordinal scale from grade 0 (fully active ie, best) to 5 (dead ie, worst). Following are ECOG grades: 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair >50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead.|Baseline to last record on study, up to 21 months|Safety population||Participants|||Number
833681|NCT01268566|Secondary|Number of Participants With Treatment-emergent Adverse Events and Serious Adverse Events|An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. Treatment-emergent AEs (TEAEs) are AEs occurring or worsening after the administration of study drug until 90 days after the last dose of study drug or until the participant began another anticancer therapy, which ever came first. A serious AE (SAE) is any AE that results in death, is immediately life threatening, require (or prolong) inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event that may jeopardize the participant or may require medical intervention to prevent one of the outcomes listed above. The TEAEs and SAEs were summarized using MedDRA version 15.1. Participants were counted only once for each event, regardless of number of events the participant had.|Baseline to last record on study, up to 21 months|Safety population included all participants who received at least 1 dose of MEDI-575.||Participants|||Number
833682|NCT01268566|Secondary|Percentage of Participants With Expression of PDGFR Alpha in the Tumor Samples|MEDI-575 (study drug) blocks platelet-derived growth factor (PDGF) binding to PDGF receptor (PDGFR) alpha and inhibits signaling. The tissue samples which were collected prior to the study entry (archived tumor samples) were evaluated by immunohistochemistry staining for expression of PDGFR alpha signaling protein that are targets of MEDI-575. Expression of PDGFR alpha in tumor cells and tumor-associated stromal cells were evaluated for intensity and distribution of staining. The percentage of participants with positive PDGFR alpha staining in the tumor cells and tumor-associated stromal cells were reported.|Screening (Day-28 to Day -1)|ITT population with archived tumor samples were assessed.||Percentage of participants|||Number
833683|NCT01268566|Secondary|Overall Survival|Overall survival is defined as the time from the start of treatment with MEDI-575 until death. For the participants who were alive at the end of study or lost to follow-up, Overall survival was censored on the last date when participants were known to be alive. The Overall survival was estimated using the Kaplan-Meier method.|Study entry to death, up to 16 months|ITT population. N= number of participants analyzed for this outcome measure||Months||90% Confidence Interval|Median
833684|NCT01268566|Secondary|Progression-free Survival|PFS was measured from the start of treatment with MEDI-575 until the documentation of disease progression or death due to any cause, whichever occurred first. Progression was defined as at least 25% increase in measurement of enhancing lesions compared with the smallest tumor measurement obtained during the study; or significant increase in T2/FLAIR nonenhancing lesion compared with baseline scan or best response; or any new lesion; or clear clinical deterioration; or failure to return for evaluation as a result of death or deteriorating condition; or clear progression of nonmeasurable disease. PFS was censored on the date of last tumor assessment documenting absence of tumor progression for participants who have no documented progression and were still alive prior to data cutoff, dropout, or the initiation of alternate anticancer treatment. Time to PFS was estimated using Kaplan-Meier method.|9 months|ITT population. N= number of participants analyzed for this outcome measure||Months||90% Confidence Interval|Median
833685|NCT01268566|Secondary|Progression-free Survival Rate at 3 Months and 9 Months|PFS rate at 3 and 9 months is defined as proportion of participants who neither progressed nor died due to any cause, whichever occurred first after first dose at 3 months and 9 months, respectively. Progression was defined as at least 25% increase in measurement of enhancing lesions compared with the smallest tumor measurement obtained during the study; or significant increase in T2/FLAIR nonenhancing lesion compared with baseline scan or best response; or any new lesion; or clear clinical deterioration; or failure to return for evaluation as a result of death or deteriorating condition; or clear progression of nonmeasurable disease. Proportion of participants with PFS at 3 and 9 months were estimated using Kaplan-Meier method.|3 months and 9 months|ITT population||Percentage of participants||90% Confidence Interval|Number
833686|NCT01268566|Secondary|Time to Progression|Time to progression (TTP) is defined as time from the start of treatment with MEDI-575 until the documentation of disease progression. Disease progression was defined by at least 25% increase in measurement of enhancing lesions compared with the smallest tumor measurement obtained during the study; or significant increase in T2/FLAIR nonenhancing lesion compared with baseline scan or best response; or any new lesion; or clear clinical deterioration; or failure to return for evaluation as a result of death or deteriorating condition; or clear progression of nonmeasurable disease. TTP was estimated using Kaplan-Meier method.|Study entry until the first documented disease progression, up to 16 months|ITT population. N= number of participants analyzed for this outcome measure||Months||90% Confidence Interval|Median
833687|NCT01268566|Secondary|Duration of Response|Duration of response is defined as the duration from the first documentation of objective disease response (ie, confirmed CR or confirmed PR) to the first documented disease progression. Duration of response was estimated using Kaplan-Meier method and evaluated only for the participants of subgroup with an objective response.||ITT population with an objective response (ie, confirmed CR or PR) were assessed. Duration of response was not estimable as there were no participants with an objective response.|||||
833688|NCT01268566|Secondary|Time to Response|Time to response (TTR) is defined as the time from the study entry to the first documentation of confirmed CR or confirmed PR. Analysis was based on responses confirmed at a repeat assessment made at least 4 weeks after the initial response, with the TTR taken as the first time the response was observed, not the confirmation assessment. TTR was estimated using Kaplan-Meier method.||ITT population with an objective response (ie, confirmed CR or PR) were assessed. TTR was not estimable as there were no participants with an objective response.|||||
833689|NCT01268566|Secondary|Percentage of Participants With Objective Response|Objective response rate (ORR) is defined as the proportion of participants with confirmed CR or confirmed PR using RANO criteria. Confirmed CR and PR are those that persist on repeat imaging study for at least 4 weeks after the initial documentation of the response. CR is defined as complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks, no new lesions, stable or improved nonenhancing (T2/FLAIR) lesions, patient is off corticosteroids and stable or improved clinically. PR is defined as 50% decrease compared with baseline in the measurement of all measurable enhancing lesions sustained for at least 4 weeks, no progression of nonmeasurable disease, no new lesions, stable or improved nonenhancing (T2/FLAIR) lesions, no increase in the corticosteroid dose and stable or improved clinically.|Study entry through the end of the study, up to 21 months|ITT population||Percentage of participants||90% Confidence Interval|Number
833690|NCT01268566|Secondary|Percentage of Participants With Best Overall Response|Best overall response rate is calculated based upon the disease assessments recorded during the study visits using RANO criteria. Best overall response includes complete response (CR), CR with confirmation, partial response (PR), PR with confirmation, stable disease and progressive disease. Confirmed responses are those that persist on repeat imaging studies at least 4 weeks after the initial documentation of response.|Study entry through the end of the study, up to 21 months|ITT population||Percentage of participants|||Number
833691|NCT01268566|Primary|Progression-free Survival Rate at 6 Months|Progression-free survival (PFS) rate at 6 months is defined as the proportion of participants who neither progressed nor died before 6 months after the first dose. Progression was determined using Updated Response Assessment Criteria of High Grade Gliomas: Response Assessment in Neuro-Oncology Working Group (RANO criteria). Progression was defined as at least 25% increase in measurement of enhancing lesions compared with the smallest tumor measurement obtained during the study; or significant increase in T2/fluid attenuated inversion recovery (FLAIR) nonenhancing lesion compared with baseline scan or best response; or any new lesion; or clear clinical deterioration; or failure to return for evaluation as a result of death or deteriorating condition; or clear progression of nonmeasurable disease. PFS-6 was estimated using Kaplan-Meier method.|6 months|Intent-to treat (ITT) population: All participants who entered into the study (ie, participants for whom investigator notified the interactive web response system [IWRS] that the participant met eligibility criteria and the IWRS assigned unblinded study drug to the participant).||Percentage of participants||90% Confidence Interval|Number
833692|NCT01268683|Secondary|Clinical and MRI Outcome Data|The proportion of subjects with mRS <=4 expressed as a % (total number of patients with mRS <=4 divided by total number of patients enrolled).|90 days|||percentage of participants|||Number
833693|NCT01268683|Secondary|Pharmacokinetics/Pharmacodynamics|The number of patients with unanticipated PK or PD responses was assessed. An unanticipated PK or PD response would have been, for instance, a peak concentration inconsistent with prior PK assessments, or an unexpectedly low blood glucose level (< 40 mg/dL)|3 days|||participants|||Number
833694|NCT01268683|Secondary|Safety and Tolerability|"AE's of special interest (cardiac events, difficulty controlling blood sugar, liver problems, and blood disorders, including anemia) will be followed for 30 days and all SAE's will be followed for 90 days.
SAE's and AE's were reviewed, and the number of subjects with unanticipated adverse events, or drug-related SAE's were assessed."|90 days|||participants|||Number
833695|NCT01268683|Primary|Rate of Recruitment|The number of months it took to enroll the 10 patients|11 months|||months|||Number
833696|NCT01268891|Secondary|Change From Baseline in UPDRS Motor Score During ON Time|UPDRS is a 42-item rating scale designed to assess Parkinson’s Disease-related disability and impairment using a patient interview and a physical examination. It has 4 parts and 4 subsection scores. A higher score indicates a worst outcome. I: mentation, behaviour and mood symptoms - 0 to 16; II: ADL - 0 to 52; III: motor function - 0 to 108; IV: complications of dopaminergic therapy - 0 to 23. Subsection scores for I to III are used to calculate a total score that ranges from 0 (no disability) to 176 (total dependence).|Baseline and Week 18|FAS; LOCF||units on a scale||Standard Error|Mean
833697|NCT01268891|Secondary|Change From Baseline in UPDRS-ADL Score During OFF Time|Unified Parkinson's Disease Rating Scale (UPDRS) is a 42-item rating scale designed to assess Parkinson's Disease-related disability and impairment using a patient interview and a physical examination. It has 4 parts and 4 subsection scores. A higher score indicates a worst outcome. I: mentation, behaviour and mood symptoms - 0 to 16; II: activities of daily living (ADL) - 0 to 52; III: motor function - 0 to 108; IV: complications of dopaminergic therapy - 0 to 23. Subsection scores for I to III are used to calculate a total score that ranges from 0 (no disability) to 176 (total dependence).|Baseline and Week 18|FAS; LOCF||units on a scale||Standard Error|Mean
833698|NCT01268891|Secondary|Clinical Status Using CGI-I Score During ON Time|Clinical Global Impression - Global Improvement (CGI-I) is a single-item rating scale used to evaluate a patient's condition relative to baseline on a 7-point scale, regardless of whether the improvement is related to the investigational medicinal product (IMP). The scale ranges from 1 (very much improved) to 7 (very much worse).|Week 18|FAS; last observation carried forward (LOCF)||units on a scale||Standard Error|Mean
833699|NCT01268891|Primary|Change From Baseline in Mean Total Daily OFF Time Using Parkinson’s Disease Patient Diary|"Parkinson’s Disease Patient Diary is a self-administered diary designed to assess motor fluctuations throughout the day. It is divided into 30-minute intervals, and the patient selects one of four options for each interval: asleep; off; on with no dyskinesia or without troublesome dyskinesia; or on with troublesome dyskinesia.
The Change From Baseline in Mean Total Daily OFF Time is calculated by taking the difference between the average of the total daily OFF time at Weeks 6, 10, 14 and 18, and the Baseline Total Daily OFF Time."|Baseline and Weeks 6, 10, 14, and 18|Full-analysis set (FAS); observed cases (OC)||hours||Standard Error|Mean
833700|NCT01268943|Primary|Dose Related Toxicity|dose related toxicity is defined as follows:1. WBC damage >= grade 3; granular cell decrease >= grade 3; hemoglobin >= grade 2; platelet >= grade 2;SGPT/SGOT elevation >= grade 2; ALP >= grade 2; GGT >= grade 2; Tbil >= grade 2;renal function damage: BUN/Cr elevation >= grade 2;Non-gradular cell decreased fever >= grade 2;nausea/vomiting >= grade 2; fatigue >= grade 3; weight loss >= grade 3;gastritis >= grade 3; dairrea >= grade 3; abdominal pain >= grade 3; pancreatitis >= grade 2; upper gastrointestinal bleeding >= grade 2;other toxic reaction >= grade 3;KPS < 50 during the treatment|up to 9 weeks|||event|||Number
833701|NCT01269125|Primary|Clinical Pregnancy Rate|Clinical pregnancy rate was confirmed by observing fetal cardiac activity on transvaginal ultrasound four weeks after a positive pregnancy test.|4 weeks after a positive pregnancy test|In order to handle the problem of small sample size bootstrap techniques are used. Ader et al recommend bootstrap procedures(a) distribution is complicated or unknown, (b) a small sample is available. Finally, the bootstrap distribution has been used in order to calculate all the confidence intervals.||Percentage||95% Confidence Interval|Mean
833702|NCT01269125|Secondary|Follicular Fluid's TNF-a Concentration.|TNF-a was measured in the FF of all women (secondary outcome measures). To prevent any cytokine alterations, only blood-free samples were used.|June 2004-August 2010|||pg/ml||Standard Deviation|Mean
833703|NCT01269125|Primary|Fertilization Rate (Percentage of Fertilized Oocytes).|The fertilization rate was estimated for every woman 24 hours after oocyte retrieval|June 2004-August 2010|||percentage||95% Confidence Interval|Mean
833704|NCT01269125|Primary|Embryo Quality (the Percentage of Grade 1 Embryos Per Participant).|Embryo development was evaluated 2 days after oocyte pick-up. The number of blastomeres and the proportion of embryo volume occupied by fragments were used for the evaluation. Embryos with < 10%, < 10-20%, < 20-30% and >30% fragments were estimated as grade 1,2,3 and 4, respectively.|June 2004-August 2010|||Percentage of grade 1 embryos||95% Confidence Interval|Mean
833705|NCT01269125|Primary|Clinical Pregnancy Rate|Clinical pregnancy was confirmed by observing fetal cardiac activity on transvaginal ultrasound four weeks after a positive pregnancy test.|June 2004-August 2010|The study period was seven years. Practical issues such as, no more funds for measuring cytokines, my transportation to different University stopped this study before reaching adequate power. The flow of the participants in our Department was low.||percentage||95% Confidence Interval|Mean
833706|NCT01269346|Secondary|Duration of Stable Disease (SD)|Defined as the period from treatment start date to the date of PD or death, whichever occurred first. Participants who were alive without having PD as of the data cutoff date were censored as of their last tumor assessment. Calculated for participants who best response was SD.|Start of study treatment to date of PD or death, whichever occurred first, or date of data cutoff (12 Sep 2013), up to approximately 2 years 9 months|FAS included all participants who received at least one dose of study drug.||Months||95% Confidence Interval|Median
833707|NCT01269346|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time from the date of the first dose of study drug until the date of first documentation of PD or date of death from any cause, whichever occurred first. Participants who died without reported PD were considered to have progressed on the day of their death. Participants who were lost to follow-up or alive and without reported PD at the end of study were censored on the date of their last tumor assessment.|Date of first dose of study drug to date of PD or death (from any cause) whichever came first, or date of data cutoff (12 Sep 2013), up to approximately 2 years 9 months|FAS included all participants who received at least one dose of study drug.||Months||95% Confidence Interval|Median
833708|NCT01269346|Secondary|Duration of Response (DOR)|Duration of response was defined for participants whose best overall response was CR or PR. Participants who died without reported PD were considered to have progressed on the day of their death. Participants who were alive at the end of the study without reported PD were censored on the date of their last tumor assessment.|Date of a confirmed CR or PR was first documented to the date of PD or death (due to any cause and in the absence of PD), whichever occurred first, or date of data cutoff (12 Sep 2013), or up to approximately 2 years 9 months|FAS included all participants who received at least one dose of study drug. Analyzed for responders only (n = 37).||Months||95% Confidence Interval|Median
833709|NCT01269346|Secondary|Time to First Response|Time to first response was defined for participants whose best overall response was a CR or PR.|From date of first dose of study drug to the earliest date that CR or PR was objectively documented, assessed up to data cutoff (12 Sep 2013), up to approximately 2 years 9 months|FAS included all participants who received at least one dose of study drug. Analyzed for responders (CR or PR) only.||Months||95% Confidence Interval|Median
833710|NCT01269346|Primary|Objective Response Rate|The Objective Response Rate (Complete Response plus Partial Response, (CR + PR)) was defined as the proportion of participants who have a best overall response of confirmed CR or PR based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as assessed by the Investigator. Tumor assessment was by computed tomography (CT)/magnetic resonance imaging (MRI). To assess best response (CR, PR, stable disease (SD), progressive disease (PD), or not estimable (NE)), the Investigator selected up to five measurable target lesions (2 per organ). All other lesions were identified as nontarget lesions. Each participant’s overall tumor burden at Baseline was compared with subsequent measurements of the target lesions. For participants with CR or PR, changes in tumor sizes had to be confirmed by repeat evaluations performed not fewer than four weeks after the initial response assessment.|Baseline (within 28 days of first infusion of study drug); Treatment Phase (every 6 weeks during the first 6 cycles); Extension Phase (every 12 weeks) to PR or CR|FAS included all participants who received at least one dose of study drug.||Percentage of participants||95% Confidence Interval|Number
833711|NCT01269710|Secondary|Change in LDL (mg/dL)|"Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with second-generation antipsychotics (SGA's) during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12 (Week 52).
Since only a single participant finished the study and had assessments through Week 52, we compiled the data from all subject endpoints (1 Week 12 visit, 2 Week 36 visits, and 1 Week 52 visit) and this is the data reported below."|Baseline and 52 Weeks|All four enrolled study participants were included in this analysis.||mg/dL||Standard Deviation|Mean
833712|NCT01269710|Secondary|Change in Triglycerides (mg/dL)|"Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with second-generation antipsychotics (SGA's) during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12 (Week 52).
Since only a single participant finished the study and had assessments through Week 52, we compiled the data from all subject endpoints (1 Week 12 visit, 2 Week 36 visits, and 1 Week 52 visit) and this is the data reported below."|Baseline and 52 Weeks|All four enrolled study participants were included in this analysis.||mg/dL||Standard Deviation|Mean
833713|NCT01269710|Secondary|Change in Total Cholesterol (mg/dL)|"Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with second-generation antipsychotics (SGA's) during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12 (Week 52).
Since only a single participant finished the study and had assessments through Week 52, we compiled the data from all subject endpoints (1 Week 12 visit, 2 Week 36 visits, and 1 Week 52 visit) and this is the data reported below."|Baseline and 52 Weeks|All four enrolled study participants were included in this analysis.||mg/dL||Standard Deviation|Mean
833714|NCT01269710|Secondary|Change in Glucose Levels (mg/dL)|"Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with second-generation antipsychotics (SGA's) during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12 (Week 52).
Since only a single participant finished the study and had assessments through Week 52, we compiled the data from all subject endpoints (1 Week 12 visit, 2 Week 36 visits, and 1 Week 52 visit) and this is the data reported below."|Baseline and 52 Weeks|All four enrolled study participants were included in this analysis.||mg/dL||Standard Deviation|Mean
833715|NCT01269710|Primary|Change in Weight (in Lbs.)|"Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with second-generation antipsychotics (SGA's) during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12 (Week 52).
Since only a single participant finished the study and had assessments through Week 52, we compiled the data from all subject endpoints (1 Week 12 visit, 2 Week 36 visits, and 1 Week 52 visit) and this is the data reported below."|Baseline and 52 Weeks|All four enrolled study participants were included in this analysis.||lbs.||Standard Deviation|Mean
833716|NCT01261975|Secondary|Surgically Induced Astigmatism (SIA)|Surgically induced astigmatism presented in dioptres at each visit.|Visits 4-8|Surgically Induced Astigmatism—FAS Population||Dioptres|Participants|Standard Deviation|Mean
833717|NCT01261975|Secondary|Surgically Induced Astigmatism (SIA)|Surgically induced astigmatism was presented in dioptres at each visit.|Visits 1-3|Surgically Induced Astigmatism, FAS Population||Dioptres|Participants|Standard Deviation|Mean
833718|NCT01261975|Secondary|Uncorrected Visual Acuity|Uncorrected visual acuity(UCVA) was assessed using logMAR charts. Change from baseline summarized by visit.|visit 5, visit 6, visit 7, visit 8|Uncorrected Visual Acuity (logMAR), change from baseline, FAS Population||logMAR|Participants|Standard Deviation|Mean
833719|NCT01261975|Secondary|Uncorrected Visual Acuity|Uncorrected visual acuity(UCVA) was assessed using logMAR charts. Change from baseline summarized by visit.|Visit 1, visit 2, visit 3, visit 4|Uncorrected Visual Acuity (logMAR), change from baseline, FAS Population||logMAR|Participants|Standard Deviation|Mean
833720|NCT01261975|Secondary|Best Corrected Visual Acuity|Best corrected distance visual acuity(BCVA) was assessed using logMAR charts. Change from baseline summarized by visit. A minus change represents an improvement of the visual acuity.|visit 5, visit 6, visit 7, visit 8|Best Corrected Distance Visual Acuity (logMAR), change from baseline, FAS Population||logMAR|Participants|Standard Deviation|Mean
833721|NCT01261975|Secondary|Best Corrected Visual Acuity|Best corrected distance visual acuity(BCVA) was assessed using logMAR charts. Change from preoperative visit summarized by visit. A minus change represents an improvement of the visual acuity|Visit 1, visit 2, visit 3, visit 4|Best Corrected Distance Visual Acuity (logMAR), Change from baseline, FAS Population||logMAR|Participants|Standard Deviation|Mean
833722|NCT01261975|Primary|Refractive Stability|Cumulative portion of eyes achieving refractive stability within 0.5 D of the final value for the remainder of the trial by surgical procedure and visit.|12 weeks|Cumulative Proportion of Eyes Achieving Refractive Stability (within 0.5 D)— Full analysis Set (FAS) Population||Eyes|Participants||Number
833723|NCT01262027|Secondary|Safety Analysis of Dovitinib: Most Frequently Reported Treatment-related Adverse Event (AEs)|Safety analysis evaluated by grading each adverse event according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 and reporting the type, frequency and severity in a summary format. Full AE reporting can be found in the Adverse Event Section.|6 months|Evaluation included all participants.||percentage of participants|||Number
833724|NCT01262027|Primary|Overall Response (Complete Response [CR], Partial Response [PR] or Stable Disease [SD]) of Participants|Number of participants experiencing CR, PR or SD as defined by Response Evaluation Criteria In Solid Tumors (RECIST). Response is anyone who experiences SD, CR or PR in first 6 months. CR: Disappearance clinical evidence active tumor by evaluation, mammogram & ultrasound. No symptoms or evidence of residual invasive tumor, including no residual tumor in axillary lymph nodes. PR: 50%/> decrease for minimum 4 weeks in measurable lesion determined by product of perpendicular diameters of lesion. Every lesion should not regress to qualify as PR; however, if lesion progresses or if new lesions appear, response cannot be classified as PR. Minor Response [MR]: Decreases in tumor masses insufficient to qualify as partial remission, i.e. <50%. SD: Between MR & PD. PD: Increase 25% measured lesion from baseline. New lesions constitutes increasing disease. Mixed responses consid|6 months|Three participants were not evaluable for response due to early departure from study.||participants|||Number
833725|NCT01262092|Primary|Illicit Opioid Use as Determine by Urine Dipsticks|urine data are from those obtained during the buprenorphine taper|3x weekly during wks 3 and 4|Those who started the bup detox (N=24) excluding 1 subjects' data in the gabapentin group due to evidence of noncompliance with medication procedures and diversion (N=1).||% of urines positive for opioids|Participants|Standard Error|Mean
833726|NCT01262105|Primary|Surgery Site CFU Density|CFU culture counts for samples taken in surgery.|Ten-minute intervals throughout procedure|||CFU/m3||95% Confidence Interval|Mean
833727|NCT01262118|Secondary|Cholesterol Efflux Rate|Cholesterol efflux rate was measured using isotope dilution method in which rate of appearance of isotope 13C-free cholesterol in plasma representing whole body efflux from tissues was assessed. Isotope 13C in plasma was measured using GC-C-IRMS.|Baseline, Week 6|FAS included all enrolled participants who had any measurement of cholesterol ester production rate available. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||(mg/kg)/hr||Standard Deviation|Mean
833728|NCT01262118|Secondary|High-density Lipoprotein Associated With Apolipoprotein A1 (HDL-apoA1) Fractional Catabolic Rate|Fractional catabolic rate for HDL-apoA1 were calculated using the 13C isotopic enrichment of VLDL as the limiting value. Isotope 13C in plasma was measured using GC-C-IRMS.|Baseline, Week 6|FAS included all enrolled participants who had any measurement of cholesterol ester production rate available. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||%/hr||Standard Deviation|Mean
833729|NCT01262118|Secondary|High-density Lipoprotein Associated With Apolipoprotein A1 (HDL-apoA1) Production Rate|HDL-apoA1 production rate were calculated using a 3-pool model with a simulation, analysis and modeling (SAAM II) program.|Baseline, Week 6|FAS included all enrolled participants who had any measurement of cholesterol ester production rate available. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||mg/kg/hr||Standard Deviation|Mean
833730|NCT01262118|Secondary|Low-density Lipoprotein Associated With Apolipoprotein B (LDL-apoB) Fractional Catabolic Rate|Fractional catabolic rate for LDL ApoB were calculated using the 13 carbon (13C) isotopic enrichment of very low density lipoprotein (VLDL) as the limiting value. Isotope 13C in plasma was measured using Gas Chromatography-Combustion-Isotope Ratio Mass Spectrometry (GC-C-IRMS).|Baseline, Week 6|FAS included all enrolled participants who had any measurement of cholesterol ester production rate available. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||%/hr||Standard Deviation|Mean
833731|NCT01262118|Secondary|Low-density Lipoprotein Associated With Apolipoprotein B (LDL-apoB) Production Rate|LDL-apoB production rate were calculated using a 3-pool model with a simulation, analysis and modeling (SAAM II) program.|Baseline, Week 6|FAS included all enrolled participants who had any measurement of cholesterol ester production rate available. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||(mg/kg)/hr||Standard Deviation|Mean
833732|NCT01262118|Secondary|Cholesterol Ester Fractional Catabolic Rate|Cholesterol ester fractional catabolic rate were calculated using a 3-pool model with a simulation, analysis and modeling (SAAM II) program. Fractional catabolic rate was the percentage of cholesterol ester which was replaced, transferred or lost per unit of time.|Baseline, Week 6|FAS included all enrolled participants who had any measurement of cholesterol ester production rate available. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||percentage ester per hour (%/hr)||Standard Deviation|Mean
833733|NCT01262118|Secondary|Low-density Lipoprotein Cholesterol (LDL-C) and Total Cholesterol Concentration|Blood level of LDL-C and total cholesterol (TC) was measured following a 12-hours fasting.|Baseline, Week 6|FAS included all enrolled participants who had any measurement of cholesterol ester production rate available.||mg/dL||Standard Deviation|Mean
833734|NCT01262118|Primary|Cholesterol Ester Production Rate at Week 6|Cholesterol ester production rate was calculated using a 3-pool model with a simulation, analysis and modeling (SAAM II) program.|Week 6|FAS included all enrolled participants who had any measurement of cholesterol ester production rate available. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||(mg/kg)/hr||Standard Deviation|Mean
833735|NCT01262118|Primary|Cholesterol Ester Production Rate at Baseline|Cholesterol ester production rate was calculated using a 3-pool model with a simulation, analysis and modeling (SAAM II) program.|Baseline|FAS included all enrolled participants who had any measurement of cholesterol ester production rate available. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||(mg per kilogram) per hour ([mg/kg]/hr)||Standard Deviation|Mean
833736|NCT01262118|Primary|High-density Lipoprotein Cholesterol (HDL-C) Concentration at Week 6|Blood level of HDL-C was measured following a 12-hours fasting.|Week 6|FAS included all enrolled participants who had any measurement of cholesterol ester production rate available.||mg/dL||Standard Deviation|Mean
833737|NCT01262118|Primary|High-density Lipoprotein Cholesterol (HDL-C) Concentration at Baseline|Blood level of HDL-C was measured following a 12-hours fasting.|Baseline|Full analysis set (FAS) included all enrolled participants who had any measurement of cholesterol ester production rate available.||milligram per deciliter (mg/dL)||Standard Deviation|Mean
833738|NCT01262131|Primary|Mean Change in 3-recording Average of the Subjects Daily Pain Rating on the 0-10 Numeric Pain Intensity Scale.|"Minimum scale value is '0' which represents 'no pain at all' and is the best outcome.
Maximum scale value is '10 which represents the 'worst pain imaginable' and is the worse outcome."|2 weeks (baseline to end of treatment)|Analysis was by intention to treat which included all enrolled subjects in this case to study completion.||Scores on a scale||Standard Deviation|Mean
833739|NCT01262287|Secondary|Change in Standard Drinks Per Week - Moderation by Genetic Variation|Moderation of primary outcome measure [change in standard drinks per week from baseline to end point (average weeks 7 and 8 of treatment)] by genetic variation rs12529 in neuroactive steroid biosynthetic enzyme gene AKR1C (AKR1C3*2 C-allele associated with alcohol use disorder)|Baseline (average weekly drinking for 90 day period prior to screening) vs. End Point (average weekly drinking weeks 7 and 8 of treatment)|||standard drinks per week||Standard Error|Mean
833740|NCT01262287|Primary|Change Number of Standard Drinks Per Week.|Change in Average Standard Drinks (14 gr ethanol) per week: last 2 weeks of treatment (wk 7-8) minus baseline average drinking average from baseline 90 day drinking history|Baseline (average weekly drinking for 90 day period prior to screening) vs. End Point (average weekly drinking weeks 7 and 8 of treatment)|||standard drinks per week||Standard Error|Mean
833741|NCT01262339|Primary|Evaluate the Efficacy of Botulinum Toxin A (BTX-A) in the Treatment of Primary Palmar Hyperhidrosis Delivered Via Iontophoresis.||26 weeks|Study was closed prematurely as principal investigator left the University of Wisconsin. Insufficient data for outcome measures analysis. Data was not entered into tabular format. Study closed and records archived.|||||
833742|NCT01262352|Secondary|Change From Baseline in CF Questionnaire-Revised (CFQ-R) Score (Respiratory Domain Score, Pooled)|The CFQ-R is a health-related quality of life measure for subjects with cystic fibrosis. Each domain is scored from 0 (worst) to 100 (best). A difference of at least 4 points in the respiratory domain score of the CFQ-R is considered a minimal clinically important difference (MCID). The primary analytical focus was the respiratory health domain, which was analyzed by combining all self-response questionnaire versions from different age groups (e.g., Adult/Adolescent and Child versions).|Baseline through Day 29|All randomized subjects who received at least 1 dose of study drug (placebo or ivacaftor) and had available assessments during the time frame.||score on a scale||Standard Error|Least Squares Mean
833743|NCT01262352|Secondary|Change From Baseline in Sweat Chloride|The sweat chloride (quantitative pilocarpine iontophoresis) test is a standard diagnostic tool for cystic fibrosis (CF), serving as an indicator of cystic fibrosis transmembrane conductance regulator (CFTR) activity.|Baseline through Day 29|All randomized subjects who received at least 1 dose of study drug (placebo or ivacaftor) and had available assessments during the time frame.||millimoles per liter||Standard Error|Least Squares Mean
833744|NCT01262352|Secondary|Absolute Change From Baseline in Percent Predicted FEV1|Spirometry (as measured by FEV1) is a standardized assessment to evaluate lung function that is the most widely used endpoint in cystic fibrosis studies.|Baseline through Day 29|All randomized subjects who received at least 1 dose of study drug (placebo or ivacaftor) and had available assessments during the time frame.||percent||Standard Error|Least Squares Mean
833745|NCT01262352|Primary|Absolute Change From Baseline in Lung Clearance Index (LCI)|Lung clearance index (LCI) is a measure of ventilation inhomogeneity that is derived from a multiple-breath washout test. The LCI was calculated as the number of lung volume turnovers (cumulative expired volume divided by the functional residual capacity [FRC]) required to reduce end-tidal SF6 concentration to 1/40th of the starting value.|Baseline through Day 29|All randomized subjects who received at least 1 dose of study drug (placebo or ivacaftor) and had available assessments during the time frame.||ratio||Standard Error|Least Squares Mean
833746|NCT01262456|Secondary|Minimum Post-Treatment Serum Sodium Levels in the Open-Label Period|Serum sodium levels were monitored at each study visit since hyponatremia is a potential serious adverse event associated with daily doses of desmopressin. The serum sodium level must have been within the normal reference range at the Screening Visit for the participant to be eligible for enrollment. A participant was to be withdrawn from the trial if the serum sodium level was <=125 mmol/L at any time.|Month 1 of open-label period (Month 4 of treatment)|Safety analysis set (SAS) during open-label treatment period||participants|||Number
833747|NCT01262456|Secondary|Minimum Post-Treatment Serum Sodium Levels in the Double-Blind Period|Serum sodium levels were monitored at each study visit since hyponatremia is a potential serious adverse event associated with daily doses of desmopressin. The serum sodium level must have been within the normal reference range at the Screening Visit for the participant to be eligible for enrollment. A participant was to be withdrawn from the trial if the serum sodium level was <=125 mmol/L at any time.|Day 1 through Month 3 (double-blind period)|Safety analysis set (SAS)||participants|||Number
833748|NCT01262456|Secondary|Summary of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Open-Label Period|A TEAE was any adverse event (AE) occurring after start of treatment and within the time of residual drug effect, i.e., within 1 day for desmopressin. An adverse drug reaction (ADR) was any AE assessed by the investigator as possibly or probably related to study drug.|Month 1 of open-label period (Month 4 of treatment)|Safety analysis set (SAS) for open label-treatment period||participants|||Number
833749|NCT01262456|Secondary|Summary of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Double-Blind Period|A TEAE was any adverse event (AE) occurring after start of treatment and within the time of residual drug effect, i.e., within 1 day for desmopressin. An adverse drug reaction (ADR) was any AE assessed by the investigator as possibly or probably related to study drug.|From Day 1 through Month 3 (double-blind period)|Safety analysis set (SAS)||participants|||Number
833750|NCT01262456|Secondary|Change From Baseline in 24-Hour Urine Volume at Month 3|"Twenty-four hour urine volume was derived from the 3-day urine volume diary. Mean urine volumes were calculated as the average over 3 consecutive 24-hour periods prior to the Month 3 visit.
The secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed. The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg)."|Day 1 (Baseline), Month 3|FAS, including participants with complete data supporting this outcome in the participant diary.||mL||Standard Deviation|Mean
833751|NCT01262456|Secondary|Change From Baseline in Nocturnal Urine Volume at Month 3|"The nocturnal urine volume was derived from the 3-day urine volume diary. The nocturnal urine volume included the volume of the first morning void. Mean urine volumes were calculated as the average over 3 consecutive 24-hour periods prior to the Month 3 visit.
The secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed. The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg)."|Day 1 (Baseline), Month 3|FAS, including participants with complete data supporting this outcome in the participant diary.||mL||Standard Deviation|Mean
833752|NCT01262456|Secondary|Change From Baseline in Mean Time to First Nocturnal Void at Month 3|"The time to first void was defined as the time from going to bed with the intention of sleeping until first nocturnal void or until waking in the morning in the case where there was no nocturnal void. The first morning void was not counted as a nocturnal void. The time to first void was derived from the sleep and voiding diary. The mean time to first void was calculated as the average over 3 consecutive 24-hour periods prior to the Month 3 visit.
The secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed. The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg)."|Day 1 (Baseline), Month 3|FAS, including participants with complete data supporting this outcome in the participant diary.||minutes||Standard Deviation|Mean
833753|NCT01262456|Secondary|Adjusted Probability of Participants Achieving a >33% Reduction From Baseline in Number of Nocturnal Voids at Month 3|"Probability of participants achieving 33% responder status at Month 3 employed a longitudinal analysis assessing nocturnal void information captured in the 3-day diary. A 33% responder was defined as a participant with a decrease of at least 33% in the mean number of nocturnal voids relative to baseline. The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to Day 1 and prior to the Month 3 visit as recorded in participant diaries. The first morning void was not counted as a nocturnal void.
The secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed. The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg)."|Day 1 (Baseline), Month 3|FAS, including participants with complete data supporting this outcome in the participant diary.||probability|||Number
833754|NCT01262456|Secondary|Change From Baseline in Mean Number of Nocturnal Voids at Month 3|"Comparison of the mean number of nocturnal voids at baseline and at the 3-month visit. The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to the relevant visits as recorded in participant diaries. The first morning void was not counted as a nocturnal void.
The secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed. The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg)."|Day 1 (Baseline), Month 3|Full Analysis Set (FAS), including participants with complete data supporting this outcome in the participant diary.||nocturnal voids||Standard Deviation|Mean
833755|NCT01262456|Primary|Adjusted Probability of Participants Achieving a >33% Reduction From Baseline in Number of Nocturnal Voids for All During-Treatment Visits up to Month 3|"Probability of participants achieving 33% responder status during 3 months of treatment employed a longitudinal analysis assessing nocturnal void information captured in the 3-day diary. A 33% responder was defined as a participant with a decrease of at least 33% in the mean number of nocturnal voids relative to baseline. The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to Day 1 and prior to the during treatment visits (Week 1, Months 1, 2, 3) as recorded in participant diaries. The first morning void was not counted as a nocturnal void.
This was the second co-primary outcome. Superiority to placebo was to be simultaneously demonstrated on the 2 co-primary endpoints in a step-down approach from highest (75 μg) to lowest dose (50 μg), thereby controlling the family-wise error rate at the 5% nominal significance level."|Day 1 (Baseline), Week 1, Months 1, 2, 3 (3-month double-blind treatment period)|Full analysis set (FAS).||probability|||Number
833756|NCT01262456|Primary|Change From Baseline in Mean Number of Nocturnal Voids Averaged Over a 3-Month Period|"The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to Day 1 and prior to the during-treatment visits (Week 1, Months 1, 2, 3) as recorded in participant diaries. The first morning void was not counted as a nocturnal void. Change from baseline values for Week 1, and Months 1, 2 and 3 are reported below.
Comparison of the mean number of nocturnal voids at baseline and over a 3-month treatment period (obtained by longitudinal analysis of Week 1, and Months 1, 2 and 3) are reported in the statistical analysis. This was the first co-primary outcome. Superiority to placebo was to be simultaneously demonstrated on the 2 co-primary outcomes in a step-down approach from highest (75 μg) to lowest dose (50 μg), thereby controlling the family-wise error rate at the 5% nominal significance level."|Day 1 (Baseline), Week 1, Months 1, 2, 3 (3-month double-blind treatment period)|Full analysis set (FAS).||nocturnal voids||Standard Deviation|Mean
833757|NCT01262547|Secondary|Incidence of Adverse Effects, Including Increased Activity of Vitiligo||24 weeks|||participants reporting redness|||Number
833758|NCT01262547|Primary|Change in Target VASI Score From Baseline to Week 24.|Target Vitiligo Area Scoring Index (VASI) consists of a 7-point scale ranging from 0 (no change in depigmentation) to 6 (complete repigmentation).|24 weeks|||units on a scale||Full Range|Mean
833759|NCT01262560|Secondary|Patient Reported Difficulty in Swallowing Associated With Manuka Honey Using the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)|Change from baseline to four weeks in patient-reported difficulty in swallowing via the PRO-CTCAE. PRO-CTCAE is an item bank consisting of individual items to assess adverse symptom events from the patient perspective. There are 78 symptoms included in the survey but the primary item of interest assesses difficulty swallowing. For each AE in the PRO-CTCAE, between 1 and 3 items are included to assess the frequency, severity, and/or interference with activities related to that AE. Frequency questions have responses ranging from never, which is scored as a 0, to almost constantly, which is scored as a 4. Severity questions have responses ranging from none, which is scored as a 0, to very severe, which is scored as a 4. Interference questions have responses ranging from not at all, which is scored as a 0, to very much, which is scored as a 4. Difficulty in swallowing only has a severity question.|Baseline and 4 weeks from the start of treatment|Randomized eligible patients who started treatment with measure at both baseline and 4 weeks.||units on a scale||Inter-Quartile Range|Median
833760|NCT01262560|Secondary|Adverse Events Associated With Manuka Honey Using CTCAE v4.0|Adverse events are graded using CTCAE v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.|Until 12 weeks from the start of treatment|Randomized eligible patients who started protocol treatment.||percentage of patients|||Number
833761|NCT01262560|Secondary|Percentage of Patients Using Opioids|The percentage of patients using opioid analgesics is reported. Use of opioid analgesics was assessed for a 24-hour period before completing the assessment. Patients with at least one reported administration of opioid analgesic were considered to have received opioid analgesics.|Baseline, 4 weeks, end of radiation treatment, and 12 weeks from the start of treatment|Randomized eligible patients with opioid use information at at least one time point.||percentage of participants|||Number
833762|NCT01262560|Secondary|Nutritional Status (Change in Serum Prealbumin Levels From Baseline to 4 Weeks)||Baseline and 4 weeks from the start of treatment|Randomized eligible patients with serum prealbumin at baseline and 4 weeks.||mg/dl||95% Confidence Interval|Mean
833763|NCT01262560|Secondary|Percent Change in Weight From Baseline to 4 Weeks||Baseline and 4 weeks from the start of treatment|Randomized eligible patients with weight at both baseline and 4 weeks.||percentage of baseline value||95% Confidence Interval|Mean
833764|NCT01262560|Secondary|Percentage of Participants With Radiation Esophagitis Grade 3-4 (CTCAE v. 4)|Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. For esophagitis specifically, Grade 3 criteria includes severely altered eating/swallowing, tube feeding, total parenteral nutrition (TPN) or hospitalization indicated. Grade 4 criteria include life-threatening consequences, urgent operative intervention indicated.|Up to 12 weeks from the start of treatment|Randomized eligible patients who started protocol treatment||percentage of participants||95% Confidence Interval|Number
833765|NCT01262560|Secondary|Quality of Life and Pain, as Measured by the EORTC QLQ-30 Global QOL Score and Pain Symptom Subscale at 4 and 12 Weeks|The pain symptom subscale (2 items) evaluated pain and the global score (30 items) evaluated quality of life. Each ranges from 0-100 with lower scores indicating lesser burden and improved symptoms or quality of life.|Baseline, 4 and 12 weeks from the start of treatment|Randomized eligible patients who received protocol treatment with at least 1 EORTC score completed across all time points.||units on a scale||Inter-Quartile Range|Median
833766|NCT01262560|Secondary|Dysphagia Via Daily Patient Log|"Dysphagia, as reported by the patient, was measured by the patient swallowing diary. Swallowing score has increasing severity 1-5, where 1 = none and 5 = cannot swallow liquids."|Weekly during treatment and 12 weeks from the start of treatment|Randomized eligible patients who received protocol treatment with at least one dysphagia score completed across all time points.||units on a scale||Inter-Quartile Range|Median
833767|NCT01262560|Secondary|Radiation Esophagitis-related Pain During Treatment as Measured During Treatment and 12 Weeks by the Numerical Rating Pain Scale (NRPS)|Esophagitis-related pain was measured using patient-reported pain on swallowing as assessed by the Numerical Rating Pain Scale (NRPS), an 11-point scale (0-10) in which 0 indicates no pain and 10 indicates the worst pain imaginable. Generally, scores of 1-4 indicate mild pain, scores of 5-6 indicate moderate pain, and scores of 7-10 indicate severe pain. Change was calculated by subtracting the baseline value from values at the later time points. The experimental arms (honey) were compared to the standard arm (supportive care).|Baseline, weekly during treatment, and 12 weeks from the start of treatment|Eligible patients who started protocol treatment with at least 1 NRPS score completed across all time points||units on a scale||Inter-Quartile Range|Median
834572|NCT01270555|Primary|Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) Score|Assesses 18 individual criteria symptoms using a severity grid (0 = not present, 3 = severe; overall minimum score = 0, maximum score = 54)|baseline and six weeks|||Units on a scale||Standard Deviation|Mean
833768|NCT01262560|Primary|Change in Radiation Esophagitis-related Pain at 4 Weeks as Measured by the Numerical Rating Pain Scale for Pain on Swallowing (NRPS)|Esophagitis-related pain was measured using patient-reported pain on swallowing as assessed by the Numerical Rating Pain Scale (NRPS), an 11-point scale (0-10) in which 0 indicates no pain and 10 indicates the worst pain imaginable. Generally, scores of 1-4 indicate mild pain, scores of 5-6 indicate moderate pain, and scores of 7-10 indicate severe pain. Change was calculated by subtracting the baseline value from the 4-week value. The experimental arms (honey) were compared to the standard arm (supportive care).|Baseline and 4 weeks from the start of treatment|Randomized eligible patients with NRPS score at both baseline and 4 weeks.||units on a scale||Inter-Quartile Range|Median
833769|NCT01262573|Secondary|Dyspareunia|Assessed preoperatively and up to 3 months postop|Postoperative|||participants|||Number
833770|NCT01262573|Primary|Vaginal Cuff Closure Time|Average time (measured in minutes)|During the surgical procedure|||minutes||Standard Deviation|Mean
833771|NCT01262599|Secondary|Levels of Cytokines|Concentration of the cytokines IL1-beta in the wound bed. Exudates will be collected from standard Jackson-Pratt #10 drains until the patient is discharged. IL1-beta is an early central proinflammatory cytokine that induces cyclooxygenase, an enzyme responsible for prostaglandin synthesis. A decrease in IL1-beta correlates with a decrease in pain. Cytokines and growth factors may contribute to more rapid post-op pain reduction and healing.|4 days||||||
833772|NCT01262599|Secondary|Amount of Narcotic Pain Medications|We will record the amount of pain medication used at twelve hour intervals for the duration of the hospital stay. Pain medications will be converted to oxycodone/acetaminophen equivalents for statistical analysis|4 days||||||
833773|NCT01262599|Primary|Pain Score Measured by Visual Analog Scale|We will record postoperative pain, as reported by the patient and quantified by a standardized visual analog scale (VAS), with written descriptions at 12 hours post-op and assess that pain level in comparison with previous timepoint pain levels, such as 1 hour post-op. The VAS pain scale ranges from 0 (no pain) to 10 (worst possible pain). Higher scores indicate more pain and lower scores indicate less pain. The mean VAS score at 12 hours is reported for each group, active or placebo.|12 hours|||units on a scale||Standard Deviation|Mean
833774|NCT01262755|Primary|Epidemiologic Factors Associated With Prevalent Reflux Disease.|Patients will complete a series of standardized questionnaires to determine the prevalence of reflux disease and risk factors for its development. We will query diet, depression, drug, tobacco, and alcohol use as well as a variety of other factors. We will study 450 African Americans living in North Philadelphia.|Two years|Patients successfully identified from targeted area.||percentage of participants with GERD||95% Confidence Interval|Number
833775|NCT01262820|Secondary|Overall Survival|Overall survival is defined as the time of enrollment until death|Eight (8) months w additional time for response date to mature (up to 2 years per participant)|||weeks||95% Confidence Interval|Median
833776|NCT01262820|Secondary|Progression Free Survival|Progression free survival is defined as time of enrollment until disease progression or death Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) : Progression is defined as a 20% increase in the sum of the diameters (longest for non-nodal lesions, short axis for nodal lesions) of all target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Target lesions are representative of all involved organs and measurable by radiographic imaging.|Eight (8) months w additional time for response data to mature (up to 2 years per participant)|||weeks||95% Confidence Interval|Median
833777|NCT01262820|Secondary|Combined Response Rate (CR + PR) of Pazopanib According to RECIST v1.1|Estimate of combined response rate (Complete Response (CR) + Partial Response (PR) per RECIST v1.1 Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) : Complete Response (CR) is defined as the disappearance of all target lesions and Partial Response (PR) as a >=30% decrease in the sum of the diameters (longest for non-nodal lesions, short axis for nodal lesions) of all target lesions.Target lesions are representative of all involved organs and measurable by radiographic imaging.|8 months with additional time for response to mature (up to 2 years per participant)|||participants|||Number
833778|NCT01262820|Primary|Disease Control Rate|Response (CR + PR + SD) as defined by RECIST v1.1 lasting equal to or greater than 12 weeks in patients treated with pazopanib alone for stage IIIB/IV non-squamous NSCLC after progression on first line therapy containing bevacizumab Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) : Complete Response (CR) is defined as Disappearance of all target lesions; Partial Response (PR), as a >=30% decrease in the sum of the diameters (longest for non-nodal lesions, short axis for nodal lesions) of all target lesions; Progression, as a 20% increase in the sum of the diameters (longest for non-nodal lesions, short axis for nodal lesions) of all target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression. Target lesions are representative of all involved organs and measurable by radiographic imaging.|Eight (8) months w additional time for response date to mature (up to 2 years per participant)|||% of participants with disease control||95% Confidence Interval|Number
833779|NCT01262846|Primary|Immunogenicity|To compare the immunogenicity of trivalent Fluzone® High-Dose vaccine vs the regular standard-dose (SD) in HIV infected individuals.|Baseline to 21 days|All participants except 5 participants with missing data at day 21||Geometric Mean antibody titer||95% Confidence Interval|Geometric Mean
833780|NCT01262872|Other Pre-specified|Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of PhtD Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs – Cohort 2|Protein sequence identity was compared to vaccine sequence. Mean and median was calculated and expressed as percentage.|At Month 0 (Pre-vaccination), Month 3 (1 month [m] post-dose [P] III-3+0 schedule or PII–2+1 schedule), Month 7 (5 m PIII - 3+0 schedule or PII–2+1 schedule) and Month 10 (8 m PIII - 3+0 schedule or 3 m post-booster–2+1 schedule)|The analysis was performed on vaccinated subjects with at least one vaccine administration documented for which S. pneumoniae isolates samples were selected for ply and phtD gene sequencing.||Percentage of protein identity|||Number
833789|NCT01262872|Secondary|Number of Subjects With Acquisition of Any New Streptococcus Pneumoniae in the Nasopharynx – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Participants|||Count of Participants
833781|NCT01262872|Other Pre-specified|Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs – Cohort 2|"Because of high variants heterogeneity in each group (no major variant), the impact of vaccination on variant prevalence was not analysed.
PhtD sequences were detected in some samples but no consensus sequence could be obtained they were defined as mixed sequences (Mix).
The samples without gene detected were considered as negative for PhtD (PhtD negative)."|At Month 0 (Pre-vaccination), Month 3 (1 month [m] post-dose [P] III-3+0 schedule or PII–2+1 schedule), Month 7 (5 m PIII - 3+0 schedule or PII–2+1 schedule) and Month 10 (8 m PIII - 3+0 schedule or 3 m post-booster–2+1 schedule)|The analysis was performed on vaccinated subjects with at least one vaccine administration documented for which S. pneumoniae isolates samples were selected for ply and phtD gene sequencing.||Samples|||Number
833782|NCT01262872|Other Pre-specified|Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of Ply Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs – Cohort 2|Protein sequence identity was compared to vaccine sequence. Mean and median was calculated and expressed as percentage.|At Month 0 (Pre-vaccination), Month 3 (1 month [m] post-dose [P] III-3+0 schedule or PII–2+1 schedule), Month 7 (5 m PIII - 3+0 schedule or PII–2+1 schedule) and Month 10 (8 m PIII - 3+0 schedule or 3 m post-booster–2+1 schedule)|The analysis was performed on vaccinated subjects with at least one vaccine administration documented for which S. pneumoniae isolates samples were selected for ply and phtD gene sequencing.||Percentage of protein identity|||Number
833783|NCT01262872|Other Pre-specified|Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs – Cohort 2|"Overall, 18 different Ply protein sequences were identified: 5 protein variants previously described (e.g. variants 1, 2, 7, 11 and 15), plus 13 new protein variants which are referred to as variants GSK21 to GSK33. The number of Amino Acids (AA) mutation versus vaccine sequence has been specified for each Ply variant.
The samples without gene detected were considered as negative for Ply (Ply negative)."|At Month 0 (Pre-vaccination), Month 3 (1 month [m] post-dose [P] III-3+0 schedule or PII–2+1 schedule), Month 7 (5 m PIII - 3+0 schedule or PII–2+1 schedule) and Month 10 (8 m PIII - 3+0 schedule or 3 m post-booster–2+1 schedule)|The analysis was performed on vaccinated subjects with at least one vaccine administration documented for which S. pneumoniae isolates samples were selected for ply and phtD gene sequencing.||Samples|||Number
833784|NCT01262872|Other Pre-specified|Description of Non-Vaccine-Type S.Pneumoniae Samples Isolated From Nasopharyngeal Swabs Before and After Vaccination for the PhtD Gene – Cohort 2|Isolates from the Prev13_3D group were not selected. Samples were distributed evenly in the 5 groups and across time points: 10 isolates from pre-vaccination, 20 at Month 3, 20 at Month 7 and 20 at Month 10. Only samples displaying non-vaccine and non-vaccine related serotypes (all serotypes except serotypes 1, 4, 5 and 14 and serotypes belonging to the serogroups 6, 7, 9, 18, 19 and 23) were selected in systematic (equal number across groups) but non-random manner. Samples were described as follows: samples with gene detected (Positive isolates) with sequenced protein, number of protein Variants, number of isolates with Variant 1 (100% identity with vaccine sequence).|At Month 0 (Pre-vaccination), Month 3 (1 month [m] post-dose [P] III-3+0 schedule or PII–2+1 schedule), Month 7 (5 m PIII - 3+0 schedule or PII–2+1 schedule) or at Month 10 (8 m PIII - 3+0 schedule or 3 m post-booster–2+1 schedule)|The analysis was performed on vaccinated subjects with at least one vaccine administration documented for which S. pneumoniae isolates samples were selected for ply and phtD gene sequencing.||Samples|||Number
833785|NCT01262872|Other Pre-specified|Description of Non-Vaccine-Type S.Pneumoniae Samples Isolated From Nasopharyngeal Swabs Before and After Vaccination for the Ply Gene – Cohort 2|Isolates from the Prev13_3D group were not selected. Samples were distributed evenly in the 5 groups and across time points: 10 isolates from pre-vaccination, 20 at Month 3, 20 at Month 7 and 20 at Month 10. Only samples displaying non-vaccine and non-vaccine related serotypes (all serotypes except serotypes 1, 4, 5 and 14 and serotypes belonging to the serogroups 6, 7, 9, 18, 19 and 23) were selected in systematic (equal number across groups) but non-random manner. Samples were described as follows: samples with gene detected (Positive isolates) with sequenced protein, number of protein Variants, number of isolates with Variant 1 (100% identity with vaccine sequence).|At Month 0 (Pre-vaccination), Month 3 (1 month [m] post-dose [P] III-3+0 schedule or PII–2+1 schedule), Month 7 (5 m PIII - 3+0 schedule or PII–2+1 schedule) or at Month 10 (8 m PIII - 3+0 schedule or 3 m post-booster–2+1 schedule)|The analysis was performed on vaccinated subjects with at least one vaccine administration documented for which S. pneumoniae isolates samples were selected for ply and phtD gene sequencing.||Samples|||Number
833786|NCT01262872|Secondary|Number of Subjects With Acquisition of Haemophilus Influenzae Strains Identified With Polymerase Chain Reaction Differentiation in the Nasopharynx – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Participants|||Count of Participants
833787|NCT01262872|Secondary|Number of Subjects With Acquisition of Haemophilus Influenzae Strains Identified With Polymerase Chain Reaction Differentiation in the Nasopharynx – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Participants|||Count of Participants
833788|NCT01262872|Secondary|Number of Subjects With Acquisition of Any New Streptococcus Pneumoniae in the Nasopharynx – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Participants|||Count of Participants
834456|NCT01278615|Secondary|Duration of Response|The Kaplan-Meier procedure will be used to characterize the duration of response. Median time-to-event and the corresponding two-sided 95% confidence intervals will be provided.|From the documented beginning of response (CR or PR) to the time of relapse, assessed up to 3 years|Zero participants were analyzed due to no response.|||||
833790|NCT01262872|Secondary|Number of Subjects With Acquisition of Non-vaccine Serotypes/Serogroups of Streptococcus Pneumoniae in the Nasopharynx – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Participants|||Count of Participants
833791|NCT01262872|Secondary|Number of Subjects With Acquisition of Non-vaccine Serotypes/Serogroups of Streptococcus Pneumoniae in the Nasopharynx – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Participants|||Count of Participants
833792|NCT01262872|Secondary|Number of Subjects With Staphylococcus Aureus in the Nasopharynx – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|Positive cultures of other bacterial pathogens [such as S. aureus, Streptococcus pyogenes (Group A streptococci) and Moraxella catarrhalis] identified in the nasopharynx were analyzed. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Participants|||Count of Participants
833793|NCT01262872|Secondary|Number of Subjects With Staphylococcus Aureus in the Nasopharynx – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|Positive cultures of other bacterial pathogens [such as S. aureus, Streptococcus pyogenes (Group A streptococci) and Moraxella catarrhalis] identified in the nasopharynx were analyzed. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Participants|||Count of Participants
833794|NCT01262872|Secondary|Number of Subjects With Group A Streptococcus in the Nasopharynx – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|Positive cultures of other bacterial pathogens [such as S. aureus, Streptococcus pyogenes (Group A streptococci) and Moraxella catarrhalis] identified in the nasopharynx were analyzed. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Participants|||Count of Participants
833795|NCT01262872|Secondary|Number of Subjects With Group A Streptococcus in the Nasopharynx – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|Positive cultures of other bacterial pathogens [such as S. aureus, Streptococcus pyogenes (Group A streptococci) and Moraxella catarrhalis] identified in the nasopharynx were analyzed.This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Participants|||Count of Participants
833796|NCT01262872|Secondary|Number of Subjects With Moraxella Catarrhalis in the Nasopharynx – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|Positive cultures of other bacterial pathogens [such as S. aureus, Streptococcus pyogenes (Group A streptococci) and Moraxella catarrhalis] identified in the nasopharynx were analyzed. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Participants|||Count of Participants
833797|NCT01262872|Secondary|Number of Subjects With Moraxella Catarrhalis in the Nasopharynx – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|Positive cultures of other bacterial pathogens [such as S. aureus, Streptococcus pyogenes (Group A streptococci) and Moraxella catarrhalis] identified in the nasopharynx were analyzed. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Participants|||Count of Participants
833798|NCT01262872|Secondary|Number of Subjects With Haemophilus Influenzae in the Nasopharynx – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Participants|||Count of Participants
833799|NCT01262872|Secondary|Number of Subjects With Haemophilus Influenzae in the Nasopharynx – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Participants|||Count of Participants
833800|NCT01262872|Secondary|Number of Subjects With Streptococcus Pneumoniae (Synflorix Related Serotypes) in the Nasopharynx – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|Related serotype = any serotype belonging to the same serogroup as the Synflorix vaccine serotypes, but different from the vaccine serotypes, was considered for the analyses of carriage of S. pneumoniae cross-related serotypes. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Participants|||Count of Participants
833801|NCT01262872|Secondary|Number of Subjects With Streptococcus Pneumoniae (Synflorix Related Serotypes) in the Nasopharynx – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|Related serotype = any serotype belonging to the same serogroup as the Synflorix vaccine serotypes, but different from the vaccine serotypes, was considered for the analyses of carriage of S. pneumoniae cross-related serotypes. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Participants|||Count of Participants
833802|NCT01262872|Secondary|Number of Subjects With Streptococcus Pneumoniae (10Pn-PD-DiT Vaccine Serotypes) in the Nasopharynx – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|Numbers of subjects with positive nasopharyngeal sample were calculated per group, at each swab time point. A Streptococcus. Pneumoniae (S. pn). vaccine pneumococcal serotype was defined as any of the pneumococcal S. pn. vaccine serotypes, e. a. serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Participants|||Count of Participants
833803|NCT01262872|Secondary|Number of Subjects With Streptococcus Pneumoniae (10Pn-PD-DiT Vaccine Serotypes) in the Nasopharynx – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|Numbers of subjects with positive nasopharyngeal sample were calculated per group, at each swab time point. A Streptococcus. Pneumoniae (S. pn). vaccine pneumococcal serotype was defined as any of the pneumococcal S. pn. vaccine serotypes, e. a. serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Participants|||Count of Participants
833804|NCT01262872|Secondary|Number of Subjects With Streptococcus Pneumoniae (Any) in the Nasopharynx – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|Numbers of subjects with positive nasopharyngeal sample were calculated per group, at each swab time point. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Participants|||Count of Participants
833805|NCT01262872|Secondary|Number of Subjects With Streptococcus Pneumoniae (Any) in the Nasopharynx – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|Numbers of subjects with positive nasopharyngeal sample were calculated per group, at each swab time point. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Participants|||Count of Participants
833806|NCT01262872|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs) – For Step 2/Cohort 2 Subjects Receiving the 2+1 Schedule|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity. These should also be considered serious: invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalisation. Any = Occurrence of an SAE, regardless of relationship to vaccination. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.|From Day 0 to Month 10|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Participants|||Count of Participants
833807|NCT01262872|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs) – For Step 2/Cohort 2 Subjects Receiving the 3+0 Schedule|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity. These should also be considered serious: invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalisation. Any = Occurrence of an SAE, regardless of relationship to vaccination. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.|From Day 0 to Month 10|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Participants|||Count of Participants
833808|NCT01262872|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs) – For Step 2/Cohort 2 Subjects Receiving the 2+1 Schedule|An unsolicited AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination. This outcome concerns Step 2/Cohort 2 subjects receiving the 2+1 Schedule.|Within the 31-day (Days 0-30) period post vaccination with Dose 3 of pneumococcal vaccine (10PP vaccine or Synflorix™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Participants|||Count of Participants
833825|NCT01262872|Secondary|Concentrations of Antibodies Against Polyribosyl Ribitol Phosphate (Anti-PRP) – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seroprotection rate = Anti-PRP antibody concentrations ≥ 0.15 µg/mL.|At 1 month post-Dose 2 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||µg/mL||95% Confidence Interval|Geometric Mean
833809|NCT01262872|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs) – For Step 2/Cohort 2 Subjects Receiving the 2+1 Schedule|An unsolicited AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination. This outcome concerns Step 2/Cohort 2 subjects receiving the 2+1 Schedule.|Within the 31-day (Days 0-30) periods post vaccination with the first 2 doses of pneumococcal vaccine (10PP vaccine or Synflorix™), across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Participants|||Count of Participants
833810|NCT01262872|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs) – For Step 2/Cohort 2 Subjects Receiving the 3+0 Schedule|An unsolicited AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination. This outcome concerns Step 2/Cohort 2 subjects receiving the 3+0 Schedule.|Within the 31-day (Days 0-30) periods post vaccination with 3 doses of pneumococcal vaccine (10PP vaccine, Synflorix™ or Prevnar 13™), across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Participants|||Count of Participants
833811|NCT01262872|Secondary|Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination – For Step 2/Cohort 2 Subjects Receiving the 2+1 Schedule|Assessed solicited general symptoms were Drowsiness, Fever (axillary temperature higher than [≥] 37.5 degrees Celsius [°C]), Irritability/Fussiness and Loss of appetite. Any = Occurrence of the specified solicited general symptom, regardless of intensity. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Fever = Axillary temperature higher than (>) 39.5°C. Grade 3 Irritability/fussiness = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. This outcome concerns Step 2/Cohort 2 subjects receiving the 2+1 Schedule.|Within the 4-day (Days 0-3) period post vaccination with Dose 3 of pneumococcal vaccine (10PP vaccine or Synflorix™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Participants|||Count of Participants
833812|NCT01262872|Secondary|Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination – For Step 2/Cohort 2 Subjects Receiving the 2+1 Schedule|Assessed solicited general symptoms were Drowsiness, Fever (axillary temperature higher than [≥] 37.5 degrees Celsius [°C]), Irritability/Fussiness and Loss of appetite. Any = Occurrence of the specified solicited general symptom, regardless of intensity. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Fever = Axillary temperature higher than (>) 39.5°C. Grade 3 Irritability/fussiness = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. This outcome concerns Step 2/Cohort 2 subjects receiving the 2+1 Schedule.|Within the 4-day (Days 0-3) periods post vaccination with the 2 first doses of pneumococcal vaccine (10PP vaccine or Synflorix™), across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Participants|||Count of Participants
833813|NCT01262872|Secondary|Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination – For Step 2/Cohort 2 Subjects Receiving the 3+0 Schedule|Assessed solicited general symptoms were Drowsiness, Fever (axillary temperature higher than [≥] 37.5 degrees Celsius [°C]), Irritability/Fussiness and Loss of appetite. Any = Occurrence of the specified solicited general symptom, regardless of intensity. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Fever = Axillary temperature higher than (>) 39.5°C. Grade 3 Irritability/fussiness = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. This outcome concerns Step 2/Cohort 2 subjects receiving the 3+0 Schedule.|Within the 4-day (Days 0-3) periods post vaccination with 3 doses of pneumococcal vaccine (10PP vaccine, Synflorix™ or Prevnar 13™), across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Participants|||Count of Participants
833814|NCT01262872|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms – For Cohort2/Step 2 Subjects Receiving the 2+1 Schedule.|Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm). This outcome concerns Cohort2/Step 2 subjects receiving the 2+1 Schedule.|Within the 4-day (Days 0-3) period post vaccination with Dose 3 of pneumococcal vaccine (10PP vaccine or Synflorix™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Participants|||Count of Participants
833826|NCT01262872|Secondary|Concentrations of Antibodies Against Polyribosyl Ribitol Phosphate (Anti-PRP) – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seroprotection rate = Anti-PRP antibody concentrations ≥ 0.15 µg/mL.|At 1 month post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||µg/mL||95% Confidence Interval|Geometric Mean
833815|NCT01262872|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms – For Cohort2/Step 2 Subjects Receiving the 2+1 Schedule.|Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm). This outcome concerns Cohort2/Step 2 subjects receiving the 2+1 Schedule.|Within the 4-day (Days 0-3) periods post vaccination with the 2 first doses of pneumococcal vaccine (10PP vaccine or Synflorix™), across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Participants|||Count of Participants
833816|NCT01262872|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms – For Cohort2/Step 2 Subjects Receiving the 3+0 Schedule.|Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm). This outcome concerns Cohort2/Step 2 subjects receiving the 3+0 Schedule.|Within the 4-day (Days 0-3) periods post vaccination with 3 doses of pneumococcal vaccine (10PP vaccine, Synflorix™ or Prevnar 13™), across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Participants|||Count of Participants
833817|NCT01262872|Secondary|Titers of Antibodies Against Yellow Fever (Anti-YF) – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seroprotection rate = Anti-yellow fever antibody titers ≥ 10.|At 3 months (Mth) post-vaccination with Stamaril™/M-Vac™|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||Titers||95% Confidence Interval|Geometric Mean
833818|NCT01262872|Secondary|Titers of Antibodies Against Yellow Fever (Anti-YF) – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seroprotection rate = Anti-yellow fever antibody titers ≥ 10.|At 3 months (Mth) post-vaccination with Stamaril™/M-Vac™|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||Titers||95% Confidence Interval|Geometric Mean
833819|NCT01262872|Secondary|Concentrations of Antibodies Against Measles (Anti-Measles) – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seroprotection rate = Anti-Measles antibody concentrations ≥ 150 mIU/mL.|At 3 months (Mth) post-vaccination with Stamaril™/M-Vac™|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||mIU/mL||95% Confidence Interval|Geometric Mean
833820|NCT01262872|Secondary|Concentrations of Antibodies Against Measles (Anti-Measles) – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seroprotection rate = Anti-Measles antibody concentrations ≥ 150 mIU/mL.|At 3 months (Mth) post-vaccination with Stamaril™/M-Vac™|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||mIU/mL||95% Confidence Interval|Geometric Mean
833821|NCT01262872|Secondary|Antibody Titers Against Poliovirus 1, 2 and 3 (Anti-Polio, Anti-Polio 2 and Anti-Polio 3) – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seroprotection rate = Anti-Polio titers ≥ 8.|At 1 month post-Dose 2 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||Titers||95% Confidence Interval|Geometric Mean
833822|NCT01262872|Secondary|Antibody Titers Against Poliovirus 1, 2 and 3 (Anti-Polio, Anti-Polio 2 and Anti-Polio 3) – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seroprotection rate = Anti-Polio titers ≥ 8.|At 1 month post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||Titers||95% Confidence Interval|Geometric Mean
833823|NCT01262872|Secondary|Concentrations of Antibodies Against Hepatitis B Surface Antigens (Anti-HBs) – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seroprotection rate = Anti-HB antibody concentrations ≥ 10 mIU/mL.|At 1 month post-Dose 2 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||mIU/mL||95% Confidence Interval|Geometric Mean
833824|NCT01262872|Secondary|Concentrations of Antibodies Against Hepatitis B Surface Antigens (Anti-HBs) – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seroprotection rate = Anti-HB antibody concentrations ≥ 10 mIU/mL.|At 1 month post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||mIU/mL||95% Confidence Interval|Geometric Mean
834133|NCT01274533|Secondary|Safety of Lenalidomide Monotherapy||28 days|The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in Aug. 2013.|||||
833827|NCT01262872|Secondary|Concentrations of Antibodies Against Bordetella Pertussis (Anti-BPT) – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seropositivity rate = Anti-BPT concentrations ≥ 15 EL.U/mL.|At 1 month post-Dose 2 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||EL.U/mL||95% Confidence Interval|Geometric Mean
833828|NCT01262872|Secondary|Concentrations of Antibodies Against Bordetella Pertussis (Anti-BPT) – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seropositivity rate = Anti-BPT concentrations ≥ 15 EL.U/mL.|At 1 month post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||EL.U/mL||95% Confidence Interval|Geometric Mean
833829|NCT01262872|Secondary|Concentrations of Antibodies Against Diphtheria (Anti-D) and Tetanus (Anti-T) – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seroprotection rate = Anti-D or anti-T antibody concentrations ≥ 0.1 IU/mL.|At 1 month post-Dose 2 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||IU/mL||95% Confidence Interval|Geometric Mean
833830|NCT01262872|Secondary|Concentrations of Antibodies Against Diphtheria (Anti-D) and Tetanus (Anti-T) – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seroprotection rate = Anti-D or anti-T antibody concentrations ≥ 0.1 IU/mL.|At 1 month post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||IU/mL||95% Confidence Interval|Geometric Mean
833831|NCT01262872|Secondary|Concentrations of Antibodies Inhibiting Pneumococcal Pneumolysin Toxoid (Ply) Haemolysis Activity, or Hem-Ply Antibodies – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|The results of analysis of the anti-Ply haemolysis activity inhibition for Cohort 2 are not presented as assay was no longer available. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||||
833832|NCT01262872|Secondary|Concentrations of Antibodies Inhibiting Pneumococcal Pneumolysin Toxoid (Ply) Haemolysis Activity, or Hem-Ply Antibodies – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|The results of analysis of the anti-Ply haemolysis activity inhibition for Cohort 2 are not presented as assay was no longer available. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||||
833833|NCT01262872|Secondary|Titers for Opsonophagocytic Activity Against Vaccine Serotype 6C – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|No analysis was performed on opsonophagocytic activity for Antibody titers against vaccine serotype 6C as no specific qualified/validated assay was available. This outcome concerns subjects enrolled in Cohort 2/Step 2.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||||
833834|NCT01262872|Secondary|Titers for Opsonophagocytic Activity Against Vaccine Serotype 6C – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|No analysis was performed on opsonophagocytic activity for antibody titers against vaccine serotype 6C as no specific qualified/validated assay was available. This outcome concerns subjects enrolled in Cohort 2/Step 2.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||||
833835|NCT01262872|Secondary|Titers for Opsonophagocytic Activity Against Vaccine Serotype 19A – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)||12/2017||||
833836|NCT01262872|Secondary|Titers for Opsonophagocytic Activity Against Vaccine Serotype 19A – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)||12/2017||||
833854|NCT01262872|Secondary|Titers for Opsonophagocytic Activity Against Vaccine Serotype 6C – For Cohort 1/Step 1 Subjects|No analysis was performed on opsonophagocytic activity for antibody titers against vaccine serotype 6C as no specific qualified/validated assay were available. This outcome concerns subjects enrolled in Cohort 1/Step 1.|At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||||
833837|NCT01262872|Secondary|Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3 and 6A – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||Titers||95% Confidence Interval|Geometric Mean
833838|NCT01262872|Secondary|Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3 and 6A – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||Titers||95% Confidence Interval|Geometric Mean
833839|NCT01262872|Secondary|Titers for Opsonophagocytic Activity Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||Titers||95% Confidence Interval|Geometric Mean
833840|NCT01262872|Secondary|Titers for Opsonophagocytic Activity Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.|At 1, 5 and 8 months post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||Titers||95% Confidence Interval|Geometric Mean
833841|NCT01262872|Secondary|Antibody Concentrations Against Vaccine Serotype 6C – For Cohort 2/Step 2 Subjects Who Received the 2+1 Schedule|No analysis was performed on Enzyme-Linked ImmunoSorbent Assay (ELISA) testing for antibody concentrations against vaccine serotype 6C as no specific qualified/validated assay was available. This outcome concerns subjects enrolled in Cohort 2/Step 2.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||||
833842|NCT01262872|Secondary|Antibody Concentrations Against Vaccine Serotype 6C – For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule|No analysis was performed on Enzyme-Linked ImmunoSorbent Assay (ELISA) testing for antibody concentrations against vaccine serotype 6C as no specific qualified/validated assay was available. This outcome concerns subjects enrolled in Cohort 2/Step 2.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||||
833843|NCT01262872|Secondary|Antibody Concentrations Against Vaccine Serotype 6A – For Cohort 2/Step 2 Subjects Who Received the 2+1 Schedule|Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)||12/2017||||
833844|NCT01262872|Secondary|Antibody Concentrations Against Vaccine Serotype 6A – For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule|Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 3+0 Schedule.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)||12/2017||||
833845|NCT01262872|Secondary|Antibody Concentrations Against Vaccine Serotypes 3 and 19A – For Cohort 2/Step 2 Subjects Who Received the 2+1 Schedule|Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||µg/mL||95% Confidence Interval|Geometric Mean
833855|NCT01262872|Secondary|Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3, 6A and 19A – For Cohort 1/Step 1 Subjects|The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns subjects enrolled in Cohort 1/Step 1.|At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||Titers||95% Confidence Interval|Geometric Mean
833846|NCT01262872|Secondary|Antibody Concentrations Against Vaccine Serotypes 3 and 19A – For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule|Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 3+0 Schedule.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||µg/mL||95% Confidence Interval|Geometric Mean
833847|NCT01262872|Secondary|Antibody Concentrations Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F – For Cohort 2/Step 2 Subjects Who Received the 2+1 Schedule|Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||µg/mL||95% Confidence Interval|Geometric Mean
833848|NCT01262872|Secondary|Antibody Concentrations Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F – For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule|Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 3+0 Schedule.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||µg/mL||95% Confidence Interval|Geometric Mean
833849|NCT01262872|Secondary|Antibody Concentrations Against Protein D (PD) – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|Anti-PD antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA) immunoassay, expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The cut-off of the assay was anti-PD antibody concentration higher than or equal to (≥) 100 EL.U/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||EL.U/mL||95% Confidence Interval|Geometric Mean
833850|NCT01262872|Secondary|Antibody Concentrations Against Protein D (PD) – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|Anti-PD antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA) immunoassay, expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The cut-off of the assay was anti-PD antibody concentration higher than or equal to (≥) 100 EL.U/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 3+0 Schedule.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||EL.U/mL||95% Confidence Interval|Geometric Mean
833851|NCT01262872|Secondary|Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (Ply) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|"Anti-Ply and anti-PhtD antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA) immunoassay and expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL).
Cut-off of the assay were concentrations higher than or equal to (≥) 12 EL.U/mL for anti-Ply antibodies and ≥ 17 EL.U/mL for anti-PhtD antibodies. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 2+1 Schedule."|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||EL.U/mL||95% Confidence Interval|Geometric Mean
833852|NCT01262872|Secondary|Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (Ply) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|"Anti-Ply and anti-PhtD antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA) immunoassay and expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL).
Cut-off of the assay were concentrations higher than or equal to (≥) 12 EL.U/mL for anti-Ply antibodies and ≥ 17 EL.U/mL for anti-PhtD antibodies. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 3+0 Schedule."|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||EL.U/mL||95% Confidence Interval|Geometric Mean
833853|NCT01262872|Secondary|Concentrations of Antibodies Inhibiting Pneumococcal Pneumolysin Toxoid (Ply) Haemolysis Activity, or Hem-Ply Antibodies – For Cohort 1/Step 1 Subjects|Concentrations of Hem-Ply antibodies were expressed as geometric mean titers . The cut-off of the assay was an Hem-Ply antibody titer ≥ 140. This outcome concerns subjects enrolled in Cohort 1/Step 1.|At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||Titers||95% Confidence Interval|Geometric Mean
833856|NCT01262872|Secondary|Titers for Opsonophagocytic Activity Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F – For Cohort 1/Step 1 Subjects|The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns subjects enrolled in Cohort 1/Step 1.|At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||Titers||95% Confidence Interval|Geometric Mean
833857|NCT01262872|Secondary|Antibody Concentrations Against Vaccine Serotype 6C – For Cohort 1/Step 1 Subjects|No analysis was performed on Enzyme-Linked ImmunoSorbent Assay (ELISA) testing for antibody concentrations against vaccine serotype 6C as no specific qualified/validated assay were available. This outcome concerns subjects enrolled in Cohort 1/Step 1.|At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||||
833858|NCT01262872|Secondary|Antibody Concentrations Against Vaccine Serotypes 3, 6A and 19A – For Cohort 1/Step 1 Subjects|Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 1/Step 1.|At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||µg/mL||95% Confidence Interval|Geometric Mean
833859|NCT01262872|Secondary|Antibody Concentrations Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F – For Cohort 1/Step 1 Subjects|Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 1/Step 1.|At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||µg/mL||95% Confidence Interval|Geometric Mean
833860|NCT01262872|Secondary|Antibody Concentrations Against Protein D (PD) – For Cohort 1/Step 1 Subjects|Anti-PD antibody concentrations were measured by Multiplex immunoassay, expressed as geometric mean concentrations (GMCs), in Luminex Units per milliliter (LU/mL). The cut-off of the assay was an anti-PD antibody concentration higher than or equal to (≥) 112 LU/mL. This outcome concerns subjects enrolled in Cohort 1/Step 1.|At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||LU/mL||95% Confidence Interval|Geometric Mean
833861|NCT01262872|Secondary|Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (Ply) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins – For Cohort 1/Step 1 Subjects|"Anti-Ply and anti-PhtD antibody concentrations were measured by Multiplex immunoassay and expressed as geometric mean concentrations (GMCs), in Luminex Units per milliliter (LU/mL).
Cut-off of the assay were concentrations higher than or equal to (≥) 599 LU/mL for anti-Ply antibodies and ≥ 391 LU/mL for anti-PhtD antibodies. This outcome concerns subjects enrolled in Cohort 1/Step 1."|At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||LU/mL||95% Confidence Interval|Geometric Mean
833862|NCT01262872|Secondary|Number of Subjects With Serious Adverse Events (SAEs) – For Step 1/Cohort 1 Subjects|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity. These should also be considered serious: invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalisation. Any = Occurrence of an SAE, regardless of relationship to vaccination. This outcome concerns subjects enrolled in Cohort 1/Step 1.|From Day 0 to Month 6|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Participants|||Count of Participants
833863|NCT01262872|Secondary|Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges – For Cohort 1/Step 1 Subjects|Assessed biochemical and haematological parameters were: Haemoglobin (Hgb), White cell count (WBC), Platelet counts, Alanine aminotransferase (ALT) and Creatinine (CREA). Per parameter, it was assessed whether subjects had laboratory values below normal, normal, or above normal range. Below = value below the laboratory reference range defined for the specified time point and laboratory parameter. Within = value within the laboratory reference range defined for the specified time point and laboratory parameter. Above = value above the laboratory reference range defined for the specified time point and laboratory parameter. Unknown = value unknown for the specified time point and laboratory parameter. This outcome concerns subjects enrolled in Cohort 1/Step 1.|At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Participants|||Count of Participants
833879|NCT01263015|Secondary|Change From Baseline in Plasma HIV-1 RNA at Weeks 2, 4, 8, 12, 16, 24, 32, 40,48, 60, 72, 84, 96, 108, 120, 132 and 144|Blood samples were collected for the measurement of HIV-1 RNA in plasma. Changes from Baseline was calculated as the post-Baseline value minus the Baseline value. Only those participants available at the indicated time points were assessed (represented by n=X, X in the category titles).|Baseline and at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132 and 144|ITT-E Population||log10 copies/mL||Standard Deviation|Mean
833864|NCT01262872|Primary|Number of Subjects With Non-vaccine Serotypes of Streptococcus Pneumoniae (S. pn.) in the Nasopharynx – For Cohort 2/Step 2, Subjects Receiving the 2+1 Schedule|Any serotype belonging to the same serogroup as the serotypes of the pneumococcal vaccine administered (10PP vaccine or Synflorix™), but different from 10 vaccine pneumococcal serotypes, was considered for this analysis of carriage. Serotypes were identified through cultures and serotyping of isolates.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Participants|||Count of Participants
833865|NCT01262872|Primary|Number of Subjects With Non-vaccine Serotypes of Streptococcus Pneumoniae (S. pn.) in the Nasopharynx – For Cohort 2/Step 2, Subjects Receiving the 3+0 Schedule|Any serotype belonging to the same serogroup as the serotypes of the pneumococcal vaccine administered (10PP vaccine or Synflorix™), but different from 10 vaccine pneumococcal serotypes, was considered for this analysis of carriage. Serotypes were identified through cultures and serotyping of the isolates.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Participants|||Count of Participants
833866|NCT01262872|Primary|Number of Subjects With Any Serious Adverse Events (SAEs) and With SAE(s) With Relationship to Vaccination - In Step 1/Cohort 1 Subjects|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity. These should also be considered serious: invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalisation. Any = Occurrence of an SAE, regardless of relationship to vaccination. Related = Occurrence of an SAE assessed by the investigator as causally related to vaccination. Primary results correspond to results for occurrences of SAE(s) assessed as related to vaccination. This outcome concerns subjects enrolled in Cohort 1/Step 1.|From Day 0 to Month 1|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Participants|||Count of Participants
833867|NCT01262872|Primary|Number of Subjects With Any and Grade 3 Unsolicited Adverse Events (AEs) With and Without Relationship to Vaccination - In Step 1/Cohort 1 Subjects|An unsolicited AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. Any = Occurrence of AE, regardless of intensity or relationship to vaccination. Grade 3 = Occurrence of AE which prevented normal activities. Related = Occurrence of AE assessed by the investigator as causally related to vaccination. Primary results correspond to results for occurrences of Grade 3 unsolicited AE(s) assessed as related to vaccination. This outcome concerns subjects enrolled in Cohort 1/Step 1.|Within the 31-day (Days 0-30) period post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Participants|||Count of Participants
833868|NCT01262872|Primary|Number of Subjects With Any and Grade 3 Solicited General Symptoms With and Without Relationship to Vaccination – For Step 1/Cohort 1 Subjects|Assessed solicited general symptoms were Drowsiness, Fever (axillary temperature higher than [≥] 37.5 degrees Celsius [°C]), Irritability/Fussiness and Loss of appetite. Any = Occurrence of the specified solicited general symptom, regardless of intensity and relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigator as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Fever = Axillary temperature higher than (>) 39.5°C. Grade 3 Irritability/fussiness = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Primary results correspond to results for occurrences of Grade 3 symptoms assessed as related to vaccination. This outcome concerns subjects enrolled in Cohort 1/Step 1.|Within the 4-day (Days 0-3) period post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Participants|||Count of Participants
833869|NCT01262872|Primary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms and Grade 3 Solicited Local Symptoms With Relationship to Vaccination – For Step 1/Cohort 1 Subjects|Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm). All solicited local symptoms were systematically considered by the investigators as causally related to vaccination. Primary results correspond to results for occurrences of Grade 3 symptoms. This outcome concerns subjects enrolled in Cohort 1/Step 1.|Within the 4-day (Days 0-3) period post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Participants|||Count of Participants
833870|NCT01262989|Primary|Cmax|Cmax is defined as the maximum or “peak” concentration of a drug observed after its administration. Cmax is one of the parameters of particular use in estimating bioavailability of drugs, by measuring the total amount of drug absorbed.|Days 1 to 3 (Period 1) and Days 9 to 11 (Period 2)|Participants who completed the study||ng/ml||Standard Deviation|Mean
833871|NCT01262989|Primary|AUC0-infinity|The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC from time 0 (prior to administration of medication) to infinity (the time of complete elimination of the drug) was calculated using the trapezoidal method. This method consists of the sum of the trapezoids' areas, determined by the collection times and their concentrations. The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption.|Days 1 to 3 (Period 1) and Days 9 to 11 (Period 2)|Participants who completed the study||ng/h/ml||Standard Deviation|Mean
834573|NCT01270581|Primary|Duration of Respiratory Support|Data not collected due to insufficient enrollment for any data analysis.|average of 7 days||||||
833872|NCT01262989|Primary|AUC0-t|The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC from time 0 (prior to administration of medication) to time t (the time of the last quantifiable concentration) was calculated using the trapezoidal method. This method consists of the sum of the trapezoids' areas, determined by the collection times and their concentrations. The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. ng, nanograms; ml, milliliter.|Days 1 to 3 (Period 1) and Days 9 to 11 (Period 2)|Participants who completed the study||ng per hour per ml (ng/h/ml)||Standard Deviation|Mean
833873|NCT01263015|Secondary|Change From Baseline in the Symptom Bother Score (SBS) at Week 4 Through Week 48|"The Symptom Distress Module (SDM) is a 20-item, self-reported questionnaire measuring the presence/perceived distress linked to symptoms associated with HIV/its treatments. Developed with support from the AIDS Clinical Trials Group of the U.S. National Institute of Allergy and Infectious Diseases, it has demonstrated construct validity and has shown strong associations with physical/mental health summary scores and with disease severity. The SDM consists of 2 main scores: symptom count and the SBS, ranging from 0 (best) to 80 (worst) and based on the degree of bother that each symptom present posed. The SBS was calculated by adding the 20 individual bother item scores, which were calculated as: 0, “I do not have this symptom”; 1, It doesn’t bother me”; 2, “It bothers me a little”; 3, “It bothers me”; 4, It bothers me a lot. Estimates are calculated from an analysis of covariance (ANCOVA) model adjusting for age, sex, race, Baseline (BL) viral load, BL CD4+ cell count, and BL SBS."|Baseline and Week 4 through 48|ITT-E Population. Participants with missing bother item scores at Week 4 had their last observation carried forward (LOCF). Only those participants contributing to the model (i.e., without missing response variables after LOCF or covariates) were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
833874|NCT01263015|Secondary|Number of Participants With the Indicated Genotypic Resistance With Virological Failure (VF) Through 144|Whole blood samples were collected from participants to provide plasma for storage samples for potential viral genotypic and phenotypic analyses. Participants with confirmed virological failure (confirmed HIV-1 RNA >=50 copies/mL throughout the study and/or confirmed HIV-1 RNA >=200 copies/mL at Week 144) had plasma samples tested for HIV-1 RT genotype and HIV-1 integrase genotype from Baseline samples and from samples collected at the time of virological failure. Genotype testing was conducted at Day 1 and at the time of suspected protocol-defined virological failure (PDVF). A genotyping assessment was made of change across all amino acids within the integrase (IN)-encoding region, with particular attention paid to specific amino acid changes associated with the development of resistance to RAL, ELV, or DTG.|Through Week 144|PDVF Genotypic Population: all participants in the ITT-E Population with available on-treatment genotypic resistance data at the time of PDVF||Participants|||Number
833875|NCT01263015|Secondary|Number of Participants With the Indicated Grade 1 to 4 Clinical and Hematology Toxicities at Week144|All Grade 1 to 4 post-Baseline-emergent chemistry toxicities included alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), asparate aminotransferase (AST), carbon dioxide (CO2) content/bicarbonate, cholesterol, creatine kinase (CK), creatinine, hyperglycemia, hyperkalemia, hypernatremia, hypoglycemia, hypokalemia, hyponatremia, low density lipoprotein (LDL) cholesterol calculation, lipase, phosphorus inorganic, total bilirubin, and triglycerides. All Grade 1 to 4 post-Baseline-emergent hematology toxities included hemoglobin, platelet count, total neutrophils, and white blood cell count. The Division of AIDS (DAIDS) defined toxicity grades as follows: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening; Grade 5, death.|From Baseline until Week 144|Safety Population: all participants who received at least one dose of investigational product||Participants|||Number
833876|NCT01263015|Secondary|Number of Participants With the Indicated Post-baseline HIV-associated Conditions and Progression, Excluding Recurrences at Week 144|Clinical disease progression (CDP) was assessed according to the Centers for Disease Control and Prevention (CDC) HIV-1 classification system. Category (CAT) A: one or more of the following conditions (CON), without any CON listed in Categories B and C: asymptomatic HIV infection, persistent generalized lymphadenopathy, acute (primary) HIV infection with accompanying illness or history of acute HIV infection. CAT B: symptomatic CON that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or that are considered by physicians to have a clinical course or to require management that is complicated by HIV infection; and not included among CON listed in clinical CAT C. CAT C: the clinical CON listed in the AIDS surveillance case definition. Indicators of CDP were defined as: CDC CAT A at Baseline (BS) to a CDC CAT C event (EV); CDC CAT B at BS to a CDC CAT C EV; CDC CAT C at BS to a new CDC CAT C EV; or CDC CAT A, B, or C at BS to death.|From Baseline until Week 144|ITT-E Population||Participants|||Number
833877|NCT01263015|Secondary|Change From Baseline in CD4+ Cell Counts at Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132 and 144|CD4 lymphocyte cells (also called T-cells or T-helper cells) are the primary targets of HIV. The CD4 count and the CD4 percentage mark the degree of immunocompromise. The CD4 count is used to stage the patient's disease, determine the risk of opportunistic illnesses, assess prognosis, and guide decisions about when to start antiretroviral therapy. Change from Baseline was calculated as the value at Indicated visit minus the Baseline value. Only those participants available at the indicated time points were assessed (represented by n=X, X in the category titles).|Baseline and Week 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132 and 144|ITT-E Population||cells per millimeters cubed (cells/mm^3)||Standard Deviation|Mean
833878|NCT01263015|Secondary|Change From Baseline in CD4+ Cell Counts at Week 144|Cluster of differentiation (CD4) lymphocyte cells (also called T-cells or T-helper cells) are the primary targets of HIV. The CD4 count and the CD4 percentage mark the degree of immunocompromise. The CD4 count is used to stage the patient's disease, determine the risk of opportunistic illnesses, assess prognosis, and guide decisions about when to start antiretroviral therapy. Change from Baseline was calculated as the Week 144 value minus the Baseline value. The least squares mean is the estimated mean change from Baseline in CD4+ cell counts at Week 144 calculated from a repeated measures model including the following covariates: treatment, visit, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, treatment*visit interaction, Baseline HIV-1 RNA*visit interaction, and Baseline CD4+ cell count*visit interaction. No assumptions were made about the correlations between a participant's readings of CD4+, i.e., the correlation matrix for within-participant errors is unstructured.|Baseline and Week 144|ITT-E Population||cells per millimeters cubed (cells/mm^3)||Standard Deviation|Least Squares Mean
834574|NCT01270620|Secondary|Amount of Intraoperative Fentanyl||From the anesthesia induction until extubation|||micrograms||Inter-Quartile Range|Median
833880|NCT01263015|Secondary|Number of Participants With a Confirmed Plasma HIV-1 RNA Level >=1000 c/mL at or After Week 16 and Before Week 24, or a Confirmed Plasma HIV-1 RNA Level >=200 c/mL at or After Week 24|Data are presented as Kaplan Meier estimates of virologic failure (VF), defined as a confirmed plasma HIV-1 RNA level >=1000 c/mL at or after Week 16 and before Week 24, or a confirmed plasma HIV-1 RNA level >=200 c/mL at or after Week 24. A plasma HIV-1 RNA value was considered to be confirmed failure if a consecutive measurement satisfied the same failure criterion. The number of participants who experienced autoimmune deficiency syndrome (AIDS) Clinical Trials Group (ACTG) VFs was measured. For participants who withdrew from the study/were not documented to have reached confirmed VF at the cut off date of the Week 48 analysis, time to VF was to be censored at the planned visit week of the last measured plasma HIV-1 RNA sample. Data for participants who missed three consecutive scheduled plasma HIV-1 RNA measurements were to be censored at the planned visit week of the last assessment prior to the 3 consecutive missed visits.|From Baseline until Week 144) (average of 877.4 days for DTG; average of 788.8 study days for EFV/TDF/FTC)|ITT-E Population||Participants|||Number
833881|NCT01263015|Secondary|Percentage of Participants With Plasma Human Immunodeficiency Virus -1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) at Week 96 and Week 144|The percentage of participants with plasma HIV-1 RNA <50 c/mL at Week 96 and Week 144 was assessed. Plasma samples were collected for the quantitative assessment of HIV-1 RNA based on the Missing, Switch, or Discontinuation equals Failure (MSDF) algorithm,as codified by the Food and Drug Administration's Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigationl product prior to the visit window) as non-responders, as well as participants who switched their concomitant antiretroviral therapy (ART) in certain scenarios. Since changes in ART were not permitted in this protocol, all such participants who changed ART were to be considered non-responders. Otherwise, virologic success or failure was to be determined by the last available HIV-1 RNA assessment while the participant was on treatment within the visit of interest window.|Week 96 and Week 144|Intent-to-Treat-Exposed (ITT-E) Population: all randomized participants who received at least one dose of study medication||Percentage of participants|||Number
833882|NCT01263015|Secondary|Time to Viral Suppression (<50 c/mL)|Viral suppression is defined as the first viral load value<50 c/mL. The Kaplan-Meier method was used to estimate time to viral suppression, defined as the time from the first dose of study treatment until the first viral load value <50 c/mL was reached. Participants who withdrew for any reason without having suppressed prior to the analysis were censored.|From Baseline until Week 144) (average of 877.4 days for DTG; average of 788.8 study days for EFV/TDF/FTC)|ITT-E Population||Days||95% Confidence Interval|Median
833883|NCT01263015|Primary|Proportion of Subjects Responding Based on Plasma HIV-1 RNA <50 c/mL at Week 48|The percentage of participants with plasma HIV-1 RNA <50 c/mL at Week 48 was assessed. Plasma samples were collected for the quantitative assessment of HIV-1 RNA based on the Missing, Switch, or Discontinuation equals Failure (MSDF) algorithm,as codified by the Food and Drug Administration's Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigationl product prior to the visit window) as non-responders, as well as participants who switched their concomitant antiretroviral therapy (ART) in certain scenarios. Since changes in ART were not permitted in this protocol, all such participants who changed ART were to be considered non-responders. Otherwise, virologic success or failure was to be determined by the last available HIV-1 RNA assessment while the participant was on treatment within the visit of interest window.|Week 48|Intent-to-Treat-Exposed (ITT-E) Population: all randomized participants who received at least one dose of study medication||Percentage of participants|||Number
833884|NCT01263028|Secondary|Change in Erythropoietin Adjusted for Change in Inflammatory Markers, Vitamin D Levels and Clinical and Demographic Confounders||24 Weeks||||||
833885|NCT01263028|Secondary|Change in Iron Supplementation||24 Weeks||||||
833886|NCT01263028|Secondary|Change in Calcium, Phosphorous,Calcium x Phosphorous Product, and Parathyroid Hormone Levels||24 Weeks||||||
833887|NCT01263028|Secondary|Change in Inflammatory Markers||24 Weeks||||||
833888|NCT01263028|Primary|Evaluate if Ergocalciferol Supplementation to Achieve 25-hydroxy Vitamin D Levels > 40ng/ml Will Decrease Erythropoietin Requirements||24 Weeks||||||
833889|NCT01263054|Secondary|Mean Change in Score of Oswestry Disability Index (ODI) Between Screening and 6 Month Follow up Visit|"ODI - score range = 0 - 100. 0 corresponds to no disability and 100 indicates the maximum disability possible. The means of these scores and their respective standard deviations are reported for each study group."|Baseline and 6 Months|Five subjects in the TransDiscal System study arm, and seven subjects in the Medical Management study arm did not provide follow-up data.||units on a scale||Standard Deviation|Mean
833890|NCT01263054|Secondary|Mean Change in Score of Patient Global Impression of Change (PGIC) Between Screening and 6 Month Follow up Visit|"PGIC - score range = 1 - 7. 1 corresponds to very much improved and 7 indicates very much worse pertaining to overall activity, symptoms, emotions, and quality of life. The means of these scores and their respective standard deviations are reported for each study group."|Baseline and 6 months|Six subjects in the TransDiscal System study arm, and seven subjects in the Medical Management study arm did not provide follow-up data.||units on a scale||Standard Error|Mean
833891|NCT01263054|Secondary|Mean Change in Score of Beck's Depression Inventory (BDI) Between Screening and 6 Month Follow up Visit|"BDI - score range = 0 - 63. 0 corresponds to minimal depression and 63 indicates severe depression. The means of these scores and their respective standard deviations are reported for each study group."|Baseline and 6 months|Five subjects in the TransDiscal System study arm, and eight subjects in the Medical Management study arm did not provide follow-up data.||units on a scale||Standard Deviation|Mean
833892|NCT01263054|Secondary|Mean Change in Score of EuroQuol 5d Visual Analog Scale (EQ-5d VAS) Between Screening and 6 Month Follow up Visit|"EQ-5d VAS - score range = 0 - 100. 0 corresponds to the worst imaginable health state and 100 indicates the best imaginable health state. The means of these scores and their respective standard deviations are reported for each study group."|Baseline and 6 months|Five subjects in the TransDiscal System study arm, and seven subjects in the Medical Management study arm did not provide follow-up data.||units on a scale||Standard Deviation|Mean
834575|NCT01270620|Secondary|Duration of Anesthesia||Time from induction to extubation|||minutes||Inter-Quartile Range|Median
834576|NCT01270620|Secondary|Duration of Surgery||Time from Incision to closure of surgery|||minutes||Inter-Quartile Range|Median
833893|NCT01263054|Secondary|Mean Change in Score of Short Form 36-Physical Functioning (SF36-PF) From Screening to 6 Month Follow up Visit|"Short Form 36-PF - score range = 0 - 100. 0 corresponds to greatest disability and 100 indicates no disability. The means of these scores and their respective standard deviations are reported for each study group."|Baseline and 6 months|Five subjects in the TransDiscal System study arm, and seven subjects in the Medical Management study arm did not provide follow-up data.||units on a scale||Standard Deviation|Mean
833894|NCT01263054|Secondary|Percentage of Study Group Subjects With Greater Than 2 Points Decrease or 30% Drop in Average Daily Pain Related Visual Analog Scale (VAS) Score.|"Visual Analog Scale (NRS) - score range = 0 - 10. 0 corresponds to no pain and 10 indicates worst pain imaginable. The means of these scores and their respective standard deviations are reported for each study group."|Baseline and 6 months|||percentage of study group|||Number
833895|NCT01263054|Primary|Change in Average Daily Pain Visual Analog Scale (VAS) Score Between Screening and Follow up.|"Visual Analog Scale (NRS) - score range = 0 - 10. 0 corresponds to no pain and 10 indicates worst pain imaginable. The means of these scores and their respective standard deviations are reported for each study group."|Baseline and 6 months|Five subjects in the TransDiscal System study arm, and six subjects in the Medical Management study arm did not provide follow-up data.||units on a scale||Standard Deviation|Mean
833896|NCT01263132|Primary|Mean Neuropathic Pain Score at Visit 6 (Week 4)|Neuropathic pain score included 10 pain descriptors (intensity, stinging, burning, dull pain, coldness, sensitivity, numbness, depth, superficial and unpleasant) quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable). Questionnaire generated a score in each of the relevant dimensions and a total score of 0-100. Higher score indicated a greater intensity of pain.|Visit 6 (Week 4)|PP population included all participants who were randomized and took at least 1 dose of study medication. In this clinical study ITT and PP populations were the same.||Units on a Scale||Standard Deviation|Mean
833897|NCT01263132|Primary|Mean Neuropathic Pain Score at Visit 5 (Week 3)|Neuropathic pain score included 10 pain descriptors (intensity, stinging, burning, dull pain, coldness, sensitivity, numbness, depth, superficial and unpleasant) quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable). Questionnaire generated a score in each of the relevant dimensions and a total score of 0-100. Higher score indicated a greater intensity of pain.|Visit 5 (Week 3)|PP population included all participants who were randomized and took at least 1 dose of study medication. In this clinical study ITT and PP populations were the same.||Units on a Scale||Standard Deviation|Mean
833898|NCT01263132|Primary|Mean Neuropathic Pain Score at Visit 4 (Week 2)|Neuropathic pain score included 10 pain descriptors (intensity, stinging, burning, dull pain, coldness, sensitivity, numbness, depth, superficial and unpleasant) quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable). Questionnaire generated a score in each of the relevant dimensions and a total score of 0-100. Higher score indicated a greater intensity of pain.|Visit 4 (Week 2)|PP population included all participants who were randomized and took at least 1 dose of study medication. In this clinical study ITT and PP populations were the same.||Units on a Scale||Standard Deviation|Mean
833899|NCT01263132|Secondary|Quality of Life Survey Assessed Using Short Form 36 (SF-36) Questionnaire|SF-36 is a standardized health survey consisting of 36 questions to measure functional health status. Summary scores are calculated using the following 8 dimensions: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The score for a component is obtained by SF-36 algorithm and it is represented as an average of the individual question scores, which are scaled 0 (not functioning) to 100 (highest functioning). Higher scores are indicative of a better health status.|Visit 2 (Baseline) to Visit 6 (Week 4)|PP population included all participants who were randomized and took at least 1 dose of study medication. In this clinical study ITT and PP populations were the same. Two participants in the MF0434 + Gabapentin group had missing values and hence are not included.||Units on a Scale||Standard Deviation|Mean
833900|NCT01263132|Primary|Mean Neuropathic Pain Score at Visit 3 (Week 1)|Neuropathic pain score included 10 pain descriptors (intensity, stinging, burning, dull pain, coldness, sensitivity, numbness, depth, superficial and unpleasant) quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable). Questionnaire generated a score in each of the relevant dimensions and a total score of 0-100. Higher score indicated a greater intensity of pain.|Visit 3 (Week 1)|Per Protocol (PP) population included all participants who were randomized and took at least 1 dose of study medication. In this clinical study Intention to treat (ITT) and PP populations were the same.||Units on a Scale||Standard Deviation|Mean
833901|NCT01263301|Primary|no Change of Vertebral Arterial Flow During Cuff Test|we used carotid duplex duplex to study the change of vertebral arterial flow during cuff test to see if there is any difference between normal participants and patients under hemodialysis. There are two patterns seen. One is that the vertebral arterial flow reversed to normal flow pattern during cuff test. The other is that there is no change of vertebral flow pattern when the flow is stopped in the arm by cuff test.|2 years|as above explained||participants|||Number
833902|NCT01263301|Primary|Change of Vertebral Flow to Normal Flow Pattern During Cuff Test|we used carotid duplex duplex to study the change of vertebral arterial flow during cuff test to see if there is any difference between normal participants and patients under hemodialysis. There are two patterns seen. One is that the vertebral arterial flow reversed to normal flow pattern during cuff test. The other is that there is no change of vertebral flow pattern when the flow is stopped in the arm by cuff test.|two year|determined as above explained||participants|||Number
833903|NCT01263301|Primary|no Change of Subclavian Arterial Flow During Cuff Test|we used carotid duplex duplex to study the change of subclavian arterial flow during cuff test to see if there is any difference between normal participants and patients under hemodialysis. There are two patterns seen. One is that the subclavian arterial flow reversed to normal flow pattern during cuff test. The other is that there is no change of subclavian flow pattern when the flow is stopped in the arm by cuff test.|one year|for there are not too many patients who have subclavian steal found by carotid duplex, we just collected all patients during the study period that have subclavian steal and all patients with vascular access that signed written consent for the examination.||participants|||Number
833958|NCT01263496|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 12).|The change between the value of blood glucose collected at week 12 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 12.|Values are Summary Statistics.||mg·hr/dL||Standard Deviation|Mean
833904|NCT01263301|Primary|Change of Subclavian Flow to Normal Flow Pattern During Cuff Test|we used carotid duplex duplex to study the change of subclavian arterial flow during cuff test to see if there is any difference between normal participants and patients under hemodialysis. There are two patterns seen. One is that the subclavian arterial flow reversed to normal flow pattern during cuff test. The other is that there is no change of subclavian flow pattern when the flow is stopped in the arm by cuff test.|two years|for there are not too many patients who have subclavian steal found by carotid duplex, we just collected all patients during the study period that have subclavian steal and all patients with vascular access that signed written consent for the examination.||participants|||Number
833905|NCT01263444|Secondary|Percentage of Patients Reaching the Target IOP (≤ 18 mmHg)|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Only one eye (study eye) was assessed.|Week 12|This analysis population includes all patients who received study medication and had at least one on-therapy study visit minus missing responses and/or visit attendance.||percentage of participants|||Number
833906|NCT01263444|Secondary|Mean Change From Baseline in IOP at Week 4|IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. Only one eye (study eye) contributed to the mean.|Baseline, Week 4|This analysis population includes all patients who received study medication and had at least one on-therapy study visit minus missing responses and/or visit attendance.||mmHg||Standard Deviation|Mean
833907|NCT01263444|Secondary|Mean Change From Baseline in IOP Per Prostaglandin Group at Week 12|IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. Only prostaglandin subgroups with ≥ 15 patients were analyzed. Only one eye (study eye) contributed to the mean.|Baseline, Week 12|This analysis population includes all patients who received study medication and had at least one on-therapy study visit minus missing responses and/or visit attendance.||mmHg||Standard Deviation|Mean
833908|NCT01263444|Primary|Mean Change From Baseline in Intraocular Pressure (IOP) at Week 12|IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. Only one eye (study eye) contributed to the mean.|Baseline, Week 12|This analysis population includes all patients who received study medication and had at least one on-therapy study visit minus missing responses and/or visit attendance.||mmHg||Standard Deviation|Mean
833909|NCT01263470|Secondary|Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)).|The change between the value of glucagons collected at week 12 or final visit and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 12|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||pg·hr/mL||Standard Deviation|Mean
833910|NCT01263470|Secondary|Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2).|The change between the value of C-peptide collected at week 12 or final visit and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||ng·hr/mL||Standard Deviation|Mean
833911|NCT01263470|Secondary|Change From Baseline in Insulin Measured by Meal Tolerance Testing - Area Under the Curve at 2 Hours (AUC(0-2)).|The change between the value of insulin collected at week 12 or final visit and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 12|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||μU·hr/mL||Standard Deviation|Mean
833912|NCT01263470|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing - Area Under the Curve at 2 Hours (AUC (0-2)).|The change between the value of blood glucose collected at week 12 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and at 2 hours after the start of the meal.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||mg·hr/dL||Standard Deviation|Mean
833913|NCT01263470|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value).|The change between the value of blood glucose collected at week 12 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and at 2 hours after the start of the meal.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
833914|NCT01263470|Secondary|Change From Baseline in Fasting C-peptide (Week 12).|The change between the value of fasting C-peptide collected at week 12 or final visit and fasting C-peptide collected at baseline.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||ng/mL||Standard Deviation|Mean
833981|NCT01263496|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 32).|The change between the value of fasting plasma glucose collected at week 32 and fasting plasma glucose collected at baseline.|Baseline and Week 32.|Values are Summary Statistics.||mg/dL||Standard Deviation|Mean
833915|NCT01263470|Secondary|Change From Baseline in Fasting C-peptide (Week 8).|The change between the value of fasting C-peptide collected at week 8 and fasting C-peptide collected at baseline.|Baseline and Week 8.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||ng/mL||Standard Deviation|Mean
833916|NCT01263470|Secondary|Change From Baseline in Fasting C-peptide (Week 4).|The change between the value of fasting C-peptide collected at week 4 and fasting C-peptide collected at baseline.|Baseline and Week 4.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||ng/mL||Standard Deviation|Mean
833917|NCT01263470|Secondary|Change From Baseline in Fasting C-peptide (Week 2).|The change between the value of fasting C-peptide collected at week 2 and fasting C-peptide collected at baseline.|Baseline and Week 2.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||ng/mL||Standard Deviation|Mean
833918|NCT01263470|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 12).|The change between the value of fasting plasma glucose collected at week 12 or final visit and fasting plasma glucose collected at baseline.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
833919|NCT01263470|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 8).|The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline.|Baseline and Week 8.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
833920|NCT01263470|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 4).|The change between the value of fasting plasma glucose collected at week 4 and fasting plasma glucose collected at baseline.|Baseline and Week 4.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
833921|NCT01263470|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 2).|The change between the value of fasting plasma glucose collected at week 2 and fasting plasma glucose collected at baseline.|Baseline and Week 2|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
833922|NCT01263470|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 8).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and glycosylated hemoglobin collected at baseline.|Baseline and Week 8.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
833923|NCT01263470|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 4).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 4 and glycosylated hemoglobin collected at baseline.|Baseline and Week 4.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
833924|NCT01263470|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 2).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 2 and glycosylated hemoglobin collected at baseline.|Baseline and Week 2.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
833925|NCT01263470|Primary|Change From Baseline in Glycosylated Hemoglobin (Week 12).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 or final visit and glycosylated hemoglobin collected at baseline.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
833926|NCT01263483|Secondary|Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)).|The change between the value of glucagons collected at week 12 or final visit and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and at 2 hours after the start of the meal.|Baseline and Week 12|Values are from the Full Analysis Set.||pg·hr/mL||Standard Deviation|Mean
833927|NCT01263483|Secondary|Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2).|The change between the value of C-peptide collected at week 12 or final visit and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and at 2 hours after the start of the meal.|Baseline and Week 12.|Values are from the Full Analysis Set.||ng·hr/mL||Standard Deviation|Mean
833928|NCT01263483|Secondary|Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2).|The change between the value of insulin collected at week 12 or final visit and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and at 2 hours after the start of the meal.|Baseline and Week 12|Values are from the Full Analysis Set.||μU·hr/mL||Standard Deviation|Mean
833929|NCT01263483|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)).|The change between the value of blood glucose collected at week 12 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and at 2 hours after the start of the meal.|Baseline and Week 12.|Values are from the Full Analysis Set.||mg·hr/dL||Standard Deviation|Mean
833930|NCT01263483|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value).|The change between the value of blood glucose collected at week 12 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and at 2 hours after the start of the meal.|Baseline and Week 12.|Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
833931|NCT01263483|Secondary|Change From Baseline in Fasting C-peptide (Week 12).|The change between the value of fasting C-peptide collected at week 12 or final visit and fasting C-peptide collected at baseline.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||ng/mL||Standard Deviation|Mean
833932|NCT01263483|Secondary|Change From Baseline in Fasting C-peptide (Week 8).|The change between the value of fasting C-peptide collected at week 8 and fasting C-peptide collected at baseline.|Baseline and Week 8.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||ng/mL||Standard Deviation|Mean
833933|NCT01263483|Secondary|Change From Baseline in Fasting C-peptide (Week 4).|The change between the value of fasting C-peptide collected at week 4 and fasting C-peptide collected at baseline.|Baseline and Week 4.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||ng/mL||Standard Deviation|Mean
833934|NCT01263483|Secondary|Change From Baseline in Fasting C-peptide (Week 2).|The change between the value of fasting C-peptide collected at week 2 and fasting C-peptide collected at baseline.|Baseline and Week 2.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||ng/mL||Standard Deviation|Mean
833935|NCT01263483|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 12).|The change between the value of fasting plasma glucose collected at week 12 or final visit and fasting plasma glucose collected at baseline.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
833936|NCT01263483|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 8).|The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline.|Baseline and Week 8.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
833937|NCT01263483|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 4).|The change between the value of fasting plasma glucose collected at week 4 and fasting plasma glucose collected at baseline.|Baseline and Week 4.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
833938|NCT01263483|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 2).|The change between the value of fasting plasma glucose collected at week 2 and fasting plasma glucose collected at baseline.|Baseline and Week 2|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
833939|NCT01263483|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 8).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and glycosylated hemoglobin collected at baseline.|Baseline and Week 8.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
833940|NCT01263483|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 4).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 4 and glycosylated hemoglobin collected at baseline.|Baseline and Week 4.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
833941|NCT01263483|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 2).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 2 and glycosylated hemoglobin collected at baseline.|Baseline and Week 2.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
833942|NCT01263483|Primary|Change From Baseline in Glycosylated Hemoglobin (Week 12).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 or final visit and glycosylated hemoglobin collected at baseline.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
833943|NCT01263496|Secondary|Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Final Visit).|The change between the value of glucagons collected at week 52 or final visit and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Final Visit (up to Week 52).|Values are Summary Statistics.||pg·hr/mL||Standard Deviation|Mean
833944|NCT01263496|Secondary|Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 52).|The change between the value of glucagons collected at week 52 and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 52.|Values are Summary Statistics.||pg·hr/mL||Standard Deviation|Mean
833945|NCT01263496|Secondary|Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 24).|The change between the value of glucagons collected at week 24 and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 24.|Values are Summary Statistics.||pg·hr/mL||Standard Deviation|Mean
833946|NCT01263496|Secondary|Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 12).|The change between the value of glucagons collected at week 12 and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 12|Values are Summary Statistics.||pg·hr/mL||Standard Deviation|Mean
833947|NCT01263496|Secondary|Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Final Visit).|The change between the value of insulin collected at week 52 or final visit and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Final Visit (up to Week 52).|Values are Summary Statistics.||μU·hr/mL||Standard Deviation|Mean
833948|NCT01263496|Secondary|Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 52).|The change between the value of insulin collected at week 52 and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 52.|Values are Summary Statistics.||μU·hr/mL||Standard Deviation|Mean
833949|NCT01263496|Secondary|Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 24).|The change between the value of insulin collected at week 24 and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 24.|Values are Summary Statistics.||μU·hr/mL||Standard Deviation|Mean
833950|NCT01263496|Secondary|Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 12).|The change between the value of insulin collected at week 12 and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 12|Values are Summary Statistics.||μU·hr/mL||Standard Deviation|Mean
833951|NCT01263496|Secondary|Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Final Visit).|The change between the value of C-peptide collected at week 52 or final visit and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Final Visit (up to Week 52).|Values are Summary Statistics.||ng·hr/mL||Standard Deviation|Mean
833952|NCT01263496|Secondary|Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 52).|The change between the value of C-peptide collected at week 52 and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 52.|Values are Summary Statistics.||ng·hr/mL||Standard Deviation|Mean
833953|NCT01263496|Secondary|Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 24).|The change between the value of C-peptide collected at week 24 and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 24.|Values are Summary Statistics.||ng·hr/mL||Standard Deviation|Mean
833954|NCT01263496|Secondary|Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 12).|The change between the value of C-peptide collected at week 12 and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 12.|Values are Summary Statistics.||ng·hr/mL||Standard Deviation|Mean
833955|NCT01263496|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Final Visit).|The change between the value of blood glucose collected at week 52 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Final Visit (up to Week 52).|Values are Summary Statistics.||mg·hr/dL||Standard Deviation|Mean
833956|NCT01263496|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 52).|The change between the value of blood glucose collected at week 52 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 52.|Values are Summary Statistics.||mg·hr/dL||Standard Deviation|Mean
833957|NCT01263496|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 24).|The change between the value of blood glucose collected at week 24 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 24.|Values are Summary Statistics.||mg·hr/dL||Standard Deviation|Mean
833959|NCT01263496|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Final Visit).|The change between the value of blood glucose collected at week 52 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Final Visit (up to Week 52).|Values are Summary Statistics.||mg/dL||Standard Deviation|Mean
833960|NCT01263496|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 52).|The change between the value of blood glucose collected at week 52 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 52.|Values are Summary Statistics.||mg/dL||Standard Deviation|Mean
833961|NCT01263496|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 24).|The change between the value of blood glucose collected at week 24 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 24.|Values are Summary Statistics.||mg/dL||Standard Deviation|Mean
833962|NCT01263496|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 12).|The change between the value of blood glucose collected at week 12 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 12.|Values are Summary Statistics.||mg/dL||Standard Deviation|Mean
833963|NCT01263496|Secondary|Change From Baseline in Fasting C-peptide (Final Visit).|The change between the value of fasting C-peptide collected at week 52 or final visit and fasting C-peptide collected at baseline.|Baseline and Final Visit (up to Week 52).|Values are Summary Statistics.||ng/mL||Standard Deviation|Mean
833964|NCT01263496|Secondary|Change From Baseline in Fasting C-peptide (Week 52).|The change between the value of fasting C-peptide collected at week 52 and fasting C-peptide collected at baseline.|Baseline and Week 52.|Values are Summary Statistics.||ng/mL||Standard Deviation|Mean
833965|NCT01263496|Secondary|Change From Baseline in Fasting C-peptide (Week 48).|The change between the value of fasting C-peptide collected at week 48 and fasting C-peptide collected at baseline.|Baseline and Week 48.|Values are Summary Statistics.||ng/mL||Standard Deviation|Mean
833966|NCT01263496|Secondary|Change From Baseline in Fasting C-peptide (Week 44).|The change between the value of fasting C-peptide collected at week 44 and fasting C-peptide collected at baseline.|Baseline and Week 44.|Values are Summary Statistics.||ng/mL||Standard Deviation|Mean
833967|NCT01263496|Secondary|Change From Baseline in Fasting C-peptide (Week 40).|The change between the value of fasting C-peptide collected at week 40 and fasting C-peptide collected at baseline.|Baseline and Week 40.|Values are Summary Statistics.||ng/mL||Standard Deviation|Mean
833968|NCT01263496|Secondary|Change From Baseline in Fasting C-peptide (Week 36).|The change between the value of fasting C-peptide collected at week 36 and fasting C-peptide collected at baseline.|Baseline and Week 36.|Values are Summary Statistics.||ng/mL||Standard Deviation|Mean
833969|NCT01263496|Secondary|Change From Baseline in Fasting C-peptide (Week 32).|The change between the value of fasting C-peptide collected at week 32 and fasting C-peptide collected at baseline.|Baseline and Week 32.|Values are Summary Statistics.||ng/mL||Standard Deviation|Mean
833970|NCT01263496|Secondary|Change From Baseline in Fasting C-peptide (Week 28).|The change between the value of fasting C-peptide collected at week 28 and fasting C-peptide collected at baseline.|Baseline and Week 28.|Values are Summary Statistics.||ng/mL||Standard Deviation|Mean
833971|NCT01263496|Secondary|Change From Baseline in Fasting C-peptide (Week 24).|The change between the value of fasting C-peptide collected at week 24 and fasting C-peptide collected at baseline.|Baseline and Week 24.|Values are Summary Statistics.||ng/mL||Standard Deviation|Mean
833972|NCT01263496|Secondary|Change From Baseline in Fasting C-peptide (Week 20).|The change between the value of fasting C-peptide collected at week 20 and fasting C-peptide collected at baseline.|Baseline and Week 20.|Values are Summary Statistics.||ng/mL||Standard Deviation|Mean
833973|NCT01263496|Secondary|Change From Baseline in Fasting C-peptide (Week 16).|The change between the value of fasting C-peptide collected at week 16 and fasting C-peptide collected at baseline.|Baseline and Week 16.|Values are Summary Statistics.||ng/mL||Standard Deviation|Mean
833974|NCT01263496|Secondary|Change From Baseline in Fasting C-peptide (Week 12).|The change between the value of fasting C-peptide collected at week 12 and fasting C-peptide collected at baseline.|Baseline and Week 12.|Values are Summary Statistics.||ng/mL||Standard Deviation|Mean
833975|NCT01263496|Secondary|Change From Baseline in Fasting Plasma Glucose (Final Visit).|The change between the value of fasting plasma glucose collected at week 52 or final visit and fasting plasma glucose collected at baseline.|Baseline and Final Visit (up to Week 52).|Values are Summary Statistics.||mg/dL||Standard Deviation|Mean
833976|NCT01263496|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 52).|The change between the value of fasting plasma glucose collected at week 52 and fasting plasma glucose collected at baseline.|Baseline and Week 52.|Values are Summary Statistics.||mg/dL||Standard Deviation|Mean
833977|NCT01263496|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 48).|The change between the value of fasting plasma glucose collected at week 48 and fasting plasma glucose collected at baseline.|Baseline and Week 48.|Values are Summary Statistics.||mg/dL||Standard Deviation|Mean
833978|NCT01263496|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 44).|The change between the value of fasting plasma glucose collected at week 44 and fasting plasma glucose collected at baseline.|Baseline and Week 44.|Values are Summary Statistics.||mg/dL||Standard Deviation|Mean
833979|NCT01263496|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 40).|The change between the value of fasting plasma glucose collected at week 40 and fasting plasma glucose collected at baseline.|Baseline and Week 40.|Values are Summary Statistics.||mg/dL||Standard Deviation|Mean
833980|NCT01263496|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 36).|The change between the value of fasting plasma glucose collected at week 36 and fasting plasma glucose collected at baseline.|Baseline and Week 36.|Values are Summary Statistics.||mg/dL||Standard Deviation|Mean
833987|NCT01263496|Secondary|Change From Baseline in Glycosylated Hemoglobin (Final Visit).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 52 or final visit and glycosylated hemoglobin collected at baseline.|Baseline and Final Visit (up to Week 52).|Values are Summary Statistics.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
833988|NCT01263496|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 52).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 52 and glycosylated hemoglobin collected at baseline.|Baseline and Week 52.|Values are Summary Statistics.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
833989|NCT01263496|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 48).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 48 and glycosylated hemoglobin collected at baseline.|Baseline and Week 48.|Values are Summary Statistics.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
833990|NCT01263496|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 44).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 44 and glycosylated hemoglobin collected at baseline.|Baseline and Week 44.|Values are Summary Statistics.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
833991|NCT01263496|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 40).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 40 and glycosylated hemoglobin collected at baseline.|Baseline and Week 40.|Values are Summary Statistics.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
833992|NCT01263496|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 36).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 36 and glycosylated hemoglobin collected at baseline.|Baseline and Week 36.|Values are Summary Statistics.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
833993|NCT01263496|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 32).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 32 and glycosylated hemoglobin collected at baseline.|Baseline and Week 32.|Values are Summary Statistics.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
833994|NCT01263496|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 28).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 28 and glycosylated hemoglobin collected at baseline.|Baseline and Week 28.|Values are Summary Statistics.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
833995|NCT01263496|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 24).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 24 and glycosylated hemoglobin collected at baseline.|Baseline and Week 24.|Values are Summary Statistics.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
833996|NCT01263496|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 20).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 20 and glycosylated hemoglobin collected at baseline.|Baseline and Week 20.|Values are Summary Statistics.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
833997|NCT01263496|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 16).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 16 and glycosylated hemoglobin collected at baseline.|Baseline and Week 16.|Values are Summary Statistics.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
833998|NCT01263496|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 12).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 and glycosylated hemoglobin collected at baseline.|Baseline and Week 12.|Values are Summary Statistics.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
833999|NCT01263496|Primary|Number of Participants With Adverse Events.|A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug and within 30 days after receiving the last dose of study drug. A TEAE may also be a pre-treatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug, which increases in intensity after the start of dosing. Adverse events data with onset occurring more than 30 days after last dose of study drug (AE start date – last dose date >30) will be listed, but not included in the summary tables below.|52 Weeks.|Adverse Event Profile in the Safety Analysis Set||participants|||Number
834000|NCT01263509|Secondary|Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Final Visit).|The change between the value of glucagons collected at week 52 or final visit and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Final Visit (up to Week 52).|Values are Summary Statistics.||pg•hr/mL||Standard Deviation|Mean
834001|NCT01263509|Secondary|Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 52).|The change between the value of glucagons collected at week 52 and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 52.|Values are Summary Statistics.||pg•hr/mL||Standard Deviation|Mean
834002|NCT01263509|Secondary|Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 24).|The change between the value of glucagons collected at week 24 and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 24.|Values are Summary Statistics.||pg•hr/mL||Standard Deviation|Mean
834003|NCT01263509|Secondary|Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 12).|The change between the value of glucagons collected at week 12 and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 12.|Values are Summary Statistics.||pg•hr/mL||Standard Deviation|Mean
834004|NCT01263509|Secondary|Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Final Visit).|The change between the value of C-peptide collected at week 52 or final visit and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Final Visit (up to Week 52).|Values are Summary Statistics.||ng•hr/mL||Standard Deviation|Mean
834005|NCT01263509|Secondary|Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 52).|The change between the value of C-peptide collected at week 52 and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 52.|Values are Summary Statistics.||ng•hr/mL||Standard Deviation|Mean
834006|NCT01263509|Secondary|Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 24).|The change between the value of C-peptide collected at week 24 and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 24.|Values are Summary Statistics.||ng•hr/mL||Standard Deviation|Mean
834007|NCT01263509|Secondary|Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 12).|The change between the value of C-peptide collected at week 12 and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 12.|Values are Summary Statistics.||ng•hr/mL||Standard Deviation|Mean
834008|NCT01263509|Secondary|Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Final Visit).|The change between the value of insulin collected at week 52 or final visit and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Final Visit (up to Week 52).|Values are Summary Statistics.||μU•hr/mL||Standard Deviation|Mean
834009|NCT01263509|Secondary|Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 52).|The change between the value of insulin collected at week 52 and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 52.|Values are Summary Statistics.||μU•hr/mL||Standard Deviation|Mean
834010|NCT01263509|Secondary|Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 24).|The change between the value of insulin collected at week 24 and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 24.|Values are Summary Statistics.||μU•hr/mL||Standard Deviation|Mean
834011|NCT01263509|Secondary|Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 12).|The change between the value of insulin collected at week 12 and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 12.|Values are Summary Statistics.||μU•hr/mL||Standard Deviation|Mean
834012|NCT01263509|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Final Visit).|The change between the value of blood glucose collected at week 52 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Final Visit (up to Week 52).|Values are Summary Statistics.||mg•hr/dL||Standard Deviation|Mean
834013|NCT01263509|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 52).|The change between the value of blood glucose collected at week 52 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 52.|Values are Summary Statistics.||mg•hr/dL||Standard Deviation|Mean
834014|NCT01263509|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 24).|The change between the value of blood glucose collected at week 24 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 24.|Values are Summary Statistics.||mg•hr/dL||Standard Deviation|Mean
834015|NCT01263509|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 12).|The change between the value of blood glucose collected at week 12 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 12.|Values are Summary Statistics.||mg•hr/dL||Standard Deviation|Mean
834016|NCT01263509|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Final Visit).|The change between the value of blood glucose collected at week 52 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Final Visit (up to Week 52).|Values are Summary Statistics.||mg/dL||Standard Deviation|Mean
834017|NCT01263509|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 52).|The change between the value of blood glucose collected at week 52 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 52.|Values are Summary Statistics.||mg/dL||Standard Deviation|Mean
834018|NCT01263509|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 24).|The change between the value of blood glucose collected at week 24 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 24.|Values are Summary Statistics.||mg/dL||Standard Deviation|Mean
834019|NCT01263509|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 12).|The change between the value of blood glucose collected at week 12 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 12.|Values are Summary Statistics.||mg/dL||Standard Deviation|Mean
834020|NCT01263509|Secondary|Change From Baseline in Fasting C-peptide (Final Visit).|The change between the value of fasting C-peptide collected at week 52 or final visit and fasting C-peptide collected at baseline.|Baseline and Final Visit (up to Week 52).|Values are Summary Statistics.||ng/mL||Standard Deviation|Mean
834021|NCT01263509|Secondary|Change From Baseline in Fasting C-peptide (Week 52).|The change between the value of fasting C-peptide collected at week 52 and fasting C-peptide collected at baseline.|Baseline and Week 52.|Values are Summary Statistics.||ng/mL||Standard Deviation|Mean
834022|NCT01263509|Secondary|Change From Baseline in Fasting C-peptide (Week 48).|The change between the value of fasting C-peptide collected at week 48 and fasting C-peptide collected at baseline.|Baseline and Week 48.|Values are Summary Statistics.||ng/mL||Standard Deviation|Mean
834023|NCT01263509|Secondary|Change From Baseline in Fasting C-peptide (Week 44).|The change between the value of fasting C-peptide collected at week 44 and fasting C-peptide collected at baseline.|Baseline and Week 44.|Values are Summary Statistics.||ng/mL||Standard Deviation|Mean
834024|NCT01263509|Secondary|Change From Baseline in Fasting C-peptide (Week 40).|The change between the value of fasting C-peptide collected at week 40 and fasting C-peptide collected at baseline.|Baseline and Week 40.|Values are Summary Statistics.||ng/mL||Standard Deviation|Mean
834025|NCT01263509|Secondary|Change From Baseline in Fasting C-peptide (Week 36).|The change between the value of fasting C-peptide collected at week 36 and fasting C-peptide collected at baseline.|Baseline and Week 36.|Values are Summary Statistics.||ng/mL||Standard Deviation|Mean
834026|NCT01263509|Secondary|Change From Baseline in Fasting C-peptide (Week 32).|The change between the value of fasting C-peptide collected at week 32 and fasting C-peptide collected at baseline.|Baseline and Week 32.|Values are Summary Statistics.||ng/mL||Standard Deviation|Mean
834027|NCT01263509|Secondary|Change From Baseline in Fasting C-peptide (Week 28).|The change between the value of fasting C-peptide collected at week 28 and fasting C-peptide collected at baseline.|Baseline and Week 28.|Values are Summary Statistics.||ng/mL||Standard Deviation|Mean
834028|NCT01263509|Secondary|Change From Baseline in Fasting C-peptide (Week 24).|The change between the value of fasting C-peptide collected at week 24 and fasting C-peptide collected at baseline.|Baseline and Week 24.|Values are Summary Statistics.||ng/mL||Standard Deviation|Mean
834029|NCT01263509|Secondary|Change From Baseline in Fasting C-peptide (Week 20).|The change between the value of fasting C-peptide collected at week 20 and fasting C-peptide collected at baseline.|Baseline and Week 20.|Values are Summary Statistics.||ng/mL||Standard Deviation|Mean
834030|NCT01263509|Secondary|Change From Baseline in Fasting C-peptide (Week 16).|The change between the value of fasting C-peptide collected at week 16 and fasting C-peptide collected at baseline.|Baseline and Week 16.|Values are Summary Statistics.||ng/mL||Standard Deviation|Mean
834031|NCT01263509|Secondary|Change From Baseline in Fasting C-peptide (Week 12).|The change between the value of fasting C-peptide collected at week 12 and fasting C-peptide collected at baseline.|Baseline and Week 12.|Values are Summary Statistics.||ng/mL||Standard Deviation|Mean
834032|NCT01263509|Secondary|Change From Baseline in Fasting C-peptide (Week 8).|The change between the value of fasting C-peptide collected at week 8 and fasting C-peptide collected at baseline.|Baseline and Week 8.|Values are Summary Statistics.||ng/mL||Standard Deviation|Mean
834033|NCT01263509|Secondary|Change From Baseline in Fasting Plasma Glucose (Final Visit).|The change between the value of fasting plasma glucose collected at week 52 or final visit and fasting plasma glucose collected at baseline.|Baseline and Final Visit (up to Week 52).|Values are Summary Statistics.||mg/dL||Standard Deviation|Mean
834034|NCT01263509|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 52).|The change between the value of fasting plasma glucose collected at week 52 and fasting plasma glucose collected at baseline.|Baseline and Week 52.|Values are Summary Statistics.||mg/dL||Standard Deviation|Mean
834035|NCT01263509|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 48).|The change between the value of fasting plasma glucose collected at week 48 and fasting plasma glucose collected at baseline.|Baseline and Week 48.|Values are Summary Statistics.||mg/dL||Standard Deviation|Mean
834036|NCT01263509|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 44).|The change between the value of fasting plasma glucose collected at week 44 and fasting plasma glucose collected at baseline.|Baseline and Week 44.|Values are Summary Statistics.||mg/dL||Standard Deviation|Mean
834037|NCT01263509|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 40).|The change between the value of fasting plasma glucose collected at week 40 and fasting plasma glucose collected at baseline.|Baseline and Week 40.|Values are Summary Statistics.||mg/dL||Standard Deviation|Mean
834038|NCT01263509|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 36).|The change between the value of fasting plasma glucose collected at week 36 and fasting plasma glucose collected at baseline.|Baseline and Week 36.|Values are Summary Statistics.||mg/dL||Standard Deviation|Mean
834039|NCT01263509|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 32).|The change between the value of fasting plasma glucose collected at week 32 and fasting plasma glucose collected at baseline.|Baseline and Week 32.|Values are Summary Statistics.||mg/dL||Standard Deviation|Mean
834040|NCT01263509|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 28).|The change between the value of fasting plasma glucose collected at week 28 and fasting plasma glucose collected at baseline.|Baseline and Week 28.|Values are Summary Statistics.||mg/dL||Standard Deviation|Mean
834041|NCT01263509|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 24).|The change between the value of fasting plasma glucose collected at week 24 and fasting plasma glucose collected at baseline.|Baseline and Week 24.|Values are Summary Statistics.||mg/dL||Standard Deviation|Mean
834046|NCT01263509|Secondary|Change From Baseline in Glycosylated Hemoglobin (Final Visit).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 52 or final visit and glycosylated hemoglobin collected at baseline.|Baseline and Final Visit (up to Week 52).|Values are Summary Statistics.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
834047|NCT01263509|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 52).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 52 and glycosylated hemoglobin collected at baseline.|Baseline and Week 52.|Values are Summary Statistics.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
834048|NCT01263509|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 48).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 48 and glycosylated hemoglobin collected at baseline.|Baseline and Week 48.|Values are Summary Statistics.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
834049|NCT01263509|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 44).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 44 and glycosylated hemoglobin collected at baseline.|Baseline and Week 44.|Values are Summary Statistics.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
834050|NCT01263509|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 40).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 40 and glycosylated hemoglobin collected at baseline.|Baseline and Week 40.|Values are Summary Statistics.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
834051|NCT01263509|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 36).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 36 and glycosylated hemoglobin collected at baseline.|Baseline and Week 36.|Values are Summary Statistics.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
834052|NCT01263509|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 32).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 32 and glycosylated hemoglobin collected at baseline.|Baseline and Week 32.|Values are Summary Statistics.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
834053|NCT01263509|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 28).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 28 and glycosylated hemoglobin collected at baseline.|Baseline and Week 28.|Values are Summary Statistics.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
834054|NCT01263509|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 24).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 24 and glycosylated hemoglobin collected at baseline.|Baseline and Week 24.|Values are Summary Statistics.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
834055|NCT01263509|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 20).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 20 and glycosylated hemoglobin collected at baseline.|Baseline and Week 20.|Values are Summary Statistics.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
834056|NCT01263509|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 16).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 16 and glycosylated hemoglobin collected at baseline.|Baseline and Week 16.|Values are Summary Statistics.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
834057|NCT01263509|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 12).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 and glycosylated hemoglobin collected at baseline.|Baseline and Week 12.|Values are Summary Statistics.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
834058|NCT01263509|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 8).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and glycosylated hemoglobin collected at baseline.|Baseline and Week 8.|Values are Summary Statistics.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
834059|NCT01263509|Primary|Number of Participants With Adverse Events.|A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug and within 30 days after receiving the last dose of study drug. A TEAE may also be a pre-treatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug, which increases in intensity after the start of dosing. Adverse events data with onset occurring more than 30 days after last dose of study drug (AE start date - last dose date >30) will be listed, but not included in the summary tables below.|52 Weeks.|Adverse Event Profile in the Safety Analysis Set||participants|||Number
834060|NCT01263561|Secondary|Complications|Complications will be evaluated for the intra-operative, early post-operative (up until 1 month) and late post-operative (from 1 month to 1 year) periods. In addition complications will be evaluated as severe (defined as a permanent reduction in vision or complications requiring a surgical intervention) and not severe (complications which resolve with conservative management). As an individual subject may have more than one complication, the number of complications will be compared between the two surgical groups.|1 year post surgery|||participants|||Number
834061|NCT01263561|Primary|Success Rate (IOP Between 5-18 mmHg and 20% Reduction From Baseline) Without Glaucoma Medication||1 year post surgery|||percentage of participants|||Number
834062|NCT01263561|Primary|Intraocular Pressure||1 year post surgery|||mmHg||Standard Deviation|Mean
834063|NCT01263639|Primary|"Patient Satisfaction as Measured by Giving an Excellent Score on a 5-point Rating"|Within 2 weeks of discharge from the hospital, but before the patient’s first clinic visit, each group will be called by the Professional Resource Group as part of regular quality improvement by the Vanderbilt Medical Center Department of Strategic Development. The patients will be asked a series of questions aimed at determining overall patient satisfaction based on interactions with the attending orthopaedic trauma surgeon.|within 2 weeks of discharge and before first clinic appointment|||participants|||Number
834064|NCT01263665|Primary|Device-related and Procedure-related Serious Adverse Events (SAEs) Within 30 Days of the Index Procedure||30 Days post-procedure|||participants|||Number
834065|NCT01263665|Primary|Successful Completion of the Assigned Treatment|Successful completion of the assigned treatment and postdeployment > stent length (of the first deployed 25 cm GORE > VIABAHN Endoprosthesis with PROPATEN Bioactive Surface) > being within 10% of pre-deployment stent length.|Evaluated immediately after the index procedure|||percentage of subjects|||Number
834066|NCT01263691|Secondary|TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14.|Toxin neutralizing antibody (TNA) levels in blinded serum samples were measured using a validated anthrax lethal toxin neutralization assay. The primary assay endpoint was the 50% neutralization factor (TNA NF50). TNA NF50 is calculated as the ratio of the 50% effective dose (ED50) of the test sample to the ED50 of a reference serum. Values below the LLOQ of the assay (ED50 of 33) were replaced with one-half the LLOQ (ED50 of 16.5) for calculation of geometric mean titer (GMT) and statistical analysis. GMT is based on log transformation.|Day 0 (pre-dose), 7, 14 (pre-dose), 21, 28, 35, 42, 56, 70, and 84.|Participants 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).||geometric mean titer||95% Confidence Interval|Geometric Mean
834067|NCT01263691|Secondary|Median Time to Peak TNA NF50 GMT for All Subjects in the Immunogenicity Population and by Gender After IM Administration of Investigational Product on Days 0 and 14.|Toxin neutralizing antibody (TNA) levels in blinded serum samples were measured using a validated anthrax lethal toxin neutralization assay. The primary assay endpoint was the 50% neutralization factor (TNA NF50). TNA NF50 is calculated as the ratio of the 50% effective dose (ED50) of the test sample to the ED50 of a reference serum. Values below the LLOQ of the assay (ED50 of 33) were replaced with one-half the LLOQ (ED50 of 16.5) for calculation of geometric mean titer (GMT) and statistical analysis. GMT is based on log transformation.|Day 0 (pre-dose), 7, 14 (pre-dose), 21, 28, 35, 42, 56, 70, and 84.|Participants 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).||days||Full Range|Median
834068|NCT01263691|Primary|Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events|"Hematology test included hemoglobin, hematocrit, white blood cell count, absolute lymphocyte count, absolute neutrophil count, absolute eosinophil count, and platelet count. Serum chemistry test included albumin, alkaline phosphatase, total bilirubin, blood urea nitrogen, creatinine, glucose, calcium, potassium, alanine aminotransferase, aspartate aminotransferase, and lactate dehydrogenase. Urinalysis included appearance, color, pH, specific gravity, ketones, protein, glucose, bilirubin, nitrite, urobilinogen, and occult blood.
Hematology tests were done on Days 0, 1, 2, 7, 28, and 56. Serum chemistry tests and urinalysis were done on Days 0, 7, 28, and 56."|Days 0-56|||percentage of participants|||Number
834069|NCT01263691|Primary|Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events|"Hematology test included hemoglobin, hematocrit, white blood cell count, absolute lymphocyte count, absolute neutrophil count, absolute eosinophil count, and platelet count. Serum chemistry test included albumin, alkaline phosphatase, total bilirubin, blood urea nitrogen, creatinine, glucose, calcium, potassium, alanine aminotransferase, aspartate aminotransferase, and lactate dehydrogenase. Urinalysis included appearance, color, pH, specific gravity, ketones, protein, glucose, bilirubin, nitrite, urobilinogen, and occult blood.
Hematology tests were done on Days 0, 1, 2, 7, 28, and 56. Serum chemistry tests and urinalysis were done on Days 0, 7, 28, and 56."|Days 0-56|||participants|||Number
834070|NCT01263691|Primary|Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14)|"Subjects recorded solicited systemic reactions (fever, fatigue, muscle aching, headache, nausea/GI upset) on diary cards for 7 days following each of two injections (Days 0 and 14) All systemic reactions collected by subjects on diary cards were recorded as adverse events.
Severity of systemic reactions was assessed using a grading scale based on FDA Guidance titled Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.
Toxicity grades for fever were derived from body temperature using the following scale:
Grade 0: <100°F
Grade 1: 100.0 - 101.5°F
Grade 2: 101.6 - 102.9°F ;
Grade 3: 103.0 - 105.0°F
For all other systemic reactions, the following scale was used:
Grade 0: not present
Grade 1: present with no limitation of activity
Grade 2: interfering with daily activities or requiring non-narcotic treatment
Grade 3: preventing normal daily activities or requiring narcotic analgesia"|Days 14-20|||percentage of participants|||Number
834071|NCT01263691|Primary|Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14)|"Subjects recorded solicited systemic reactions (fever, fatigue, muscle aching, headache, nausea/GI upset) on diary cards for 7 days following each of two injections (Days 0 and 14) All systemic reactions collected by subjects on diary cards were recorded as adverse events.
Severity of systemic reactions was assessed using a grading scale based on FDA Guidance titled Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.
Toxicity grades for fever were derived from body temperature using the following scale:
Grade 0: <100°F
Grade 1: 100.0 - 101.5°F
Grade 2: 101.6 - 102.9°F ;
Grade 3: 103.0 - 105.0°F
For all other systemic reactions, the following scale was used:
Grade 0: not present
Grade 1: present with no limitation of activity
Grade 2: interfering with daily activities or requiring non-narcotic treatment
Grade 3: preventing normal daily activities or requiring narcotic analgesia"|Days 14-20|||participants|||Number
834072|NCT01263691|Primary|Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0)|"Subjects recorded solicited systemic reactions (fever, fatigue, muscle aching, headache, nausea/GI upset) on diary cards for 7 days following each of two injections (Days 0 and 14) All systemic reactions collected by subjects on diary cards were recorded as adverse events.
Severity of systemic reactions was assessed using a grading scale based on FDA Guidance titled Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.
Toxicity grades for fever were derived from body temperature using the following scale:
Grade 0: <100°F
Grade 1: 100.0 - 101.5°F
Grade 2: 101.6 - 102.9°F ;
Grade 3: 103.0 - 105.0°F
For all other systemic reactions, the following scale was used:
Grade 0: not present
Grade 1: present with no limitation of activity
Grade 2: interfering with daily activities or requiring non-narcotic treatment
Grade 3: preventing normal daily activities or requiring narcotic analgesia"|Days 0-6|||percentage of participants|||Number
834073|NCT01263691|Primary|Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0)|"Subjects recorded solicited systemic reactions (fever, fatigue, muscle aching, headache, nausea/GI upset) on diary cards for 7 days following each of two injections (Days 0 and 14) All systemic reactions collected by subjects on diary cards were recorded as adverse events.
Severity of systemic reactions was assessed using a grading scale based on FDA Guidance titled “Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.”
Toxicity grades for fever were derived from body temperature using the following scale:
Grade 0: <100°F
Grade 1: 100.0 – 101.5°F
Grade 2: 101.6 – 102.9°F ;
Grade 3: 103.0 – 105.0°F
For all other systemic reactions, the following scale was used:
Grade 0: not present
Grade 1: present with no limitation of activity
Grade 2: interfering with daily activities or requiring non-narcotic treatment
Grade 3: preventing normal daily activities or requiring narcotic analgesia"|Days 0-6|||Participants|||Number
834074|NCT01263691|Primary|Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14)|"Subjects recorded solicited injection site reactions (ISRs) (redness, swelling, tenderness, pain, itching, arm motion limitation) on diary cards for 7 days following the second injection (Day 14).
All local reactions collected by subjects on diary cards were recorded as adverse events.
Severity of ISR was assessed using a grading scale based on FDA Guidance Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.
Swelling/edema and redness/erythema were graded by the greater of two perpendicular measurements of diameter rated as follows:
Grade 0: none
Grade 1: <3 cm
Grade 2: 3 to 10 cm
Grade 3: >10 cm
For all other ISRs, the following scale was used:
Grade 0: not present
Grade 1: present with no limitation of activity
Grade 2: interfering with daily activities or requiring non-narcotic treatment
Grade 3: preventing normal daily activities or requiring narcotic analgesia"|Days 14-20|||Percentage of Participants|||Number
834075|NCT01263691|Primary|Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14)|"Subjects recorded solicited injection site reactions (ISRs) (redness, swelling, tenderness, pain, itching, arm motion limitation) on diary cards for 7 days following the second injection (Day 14).
All local reactions collected by subjects on diary cards were recorded as adverse events.
Severity of ISR was assessed using a grading scale based on FDA Guidance Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.
Swelling/edema and redness/erythema were graded by the greater of two perpendicular measurements of diameter rated as follows:
Grade 0: none
Grade 1: <3 cm
Grade 2: 3 to 10 cm
Grade 3: >10 cm
For all other ISRs, the following scale was used:
Grade 0: not present
Grade 1: present with no limitation of activity
Grade 2: interfering with daily activities or requiring non-narcotic treatment
Grade 3: preventing normal daily activities or requiring narcotic analgesia"|Days 14-20|||Participants|||Number
834076|NCT01263691|Primary|Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0)|"Subjects recorded solicited injection site reactions (ISRs) (redness, swelling, tenderness, pain, itching, arm motion limitation) on diary cards for 7 days following the first injection (Day 0).
All local reactions collected by subjects on diary cards were recorded as adverse events.
Severity of ISR was assessed using a grading scale based on FDA Guidance Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.
Swelling/edema and redness/erythema were graded by the greater of two perpendicular measurements of diameter rated as follows:
Grade 0: none
Grade 1: <3 cm
Grade 2: 3 to 10 cm
Grade 3: >10 cm
For all other ISRs, the following scale was used:
Grade 0: not present
Grade 1: present with no limitation of activity
Grade 2: interfering with daily activities or requiring non-narcotic treatment
Grade 3: preventing normal daily activities or requiring narcotic analgesia"|Days 0-6|||Percentage of Participants|||Number
834077|NCT01263691|Secondary|Peak TNA NF50 GMT for All Subjects in the Immunogenicity Population and by Gender After IM Administration of Investigational Product on Days 0 and 14.|Toxin neutralizing antibody (TNA) levels in blinded serum samples were measured using a validated anthrax lethal toxin neutralization assay. The primary assay endpoint was the 50% neutralization factor (TNA NF50). TNA NF50 is calculated as the ratio of the 50% effective dose (ED50) of the test sample to the ED50 of a reference serum. Values below the lower limit of quantitation (LLOQ) of the assay (ED50 of 33) were replaced with one-half the LLOQ (ED50 of 16.5) for calculation of geometric mean titer (GMT) and statistical analysis. GMT is based on log transformation.|Day 0 (pre-dose), 7, 14 (pre-dose), 21, 28, 35, 42, 56, 70, and 84.|Participants 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).||geometric mean titer||95% Confidence Interval|Geometric Mean
834131|NCT01274429|Secondary|Determine the Effect That PNOIT Has on the Peanut-specific Cellular and Humoral Response in Peanut-allergic Subjects.|Measure changes over the course of treatment in serum specific IgE and IgG4, skin prick tests, TH1 and TH2 cytokines, and CD4+ CD25+ FoxP3+ regulatory T cells|2-3 years|No subjects reached the end of study prior to closure of the study and therefore no end of treatment mechanistic data was collected in order to compare against the baseline.|||||
834078|NCT01263691|Primary|Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0)|"Subjects recorded solicited injection site reactions (ISRs) (redness, swelling, tenderness, pain, itching, arm motion limitation) on diary cards for 7 days following the first injection (Day 0).
All local reactions collected by subjects on diary cards were recorded as adverse events.
Severity of ISR was assessed using a grading scale based on FDA Guidance “Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.”
Swelling/edema and redness/erythema were graded by the greater of two perpendicular measurements of diameter rated as follows:
Grade 0: none
Grade 1: <3 cm
Grade 2: 3 to 10 cm
Grade 3: >10 cm
For all other ISRs, the following scale was used:
Grade 0: not present
Grade 1: present with no limitation of activity
Grade 2: interfering with daily activities or requiring non-narcotic treatment
Grade 3: preventing normal daily activities or requiring narcotic analgesia"|Days 0-6|||Participants|||Number
834091|NCT01263873|Primary|Ease of Intubation, as Measured by an Ease of ETT Insertion Score.|To measure the ease of intubation, an ease of ETT insertion score was obtained by using a 100 millimeter visual analog scale done by the anesthesia provider doing the intubation. The score of 0 millimeters was the easiest intubation and a score of 100 millimeters was the hardest intubation done by that anesthesia provider.|Participants were followed for the duration of intubation, an average of 10 minutes|||Visual Analog Score in millimeters||Standard Deviation|Mean
834092|NCT01263873|Primary|Ease of Intubation, as Measured by Number of ETT Redirections|To measure the ease of intubation, once the airway structure was visualized with the GlideScope, the number of ETT redirections at the glottis to intubate the trachea was counted by video recordings by the PI.|Participants were followed for the duration of intubation, an average of 10 minutes|||Number of redirections to place ETT||Standard Deviation|Mean
834093|NCT01263873|Primary|Ease of Intubation, as Measured by Time in Seconds for ETT Insertion|To measure the ease of intubation by time in seconds for ETT insertion. Time was measured in seconds and started when the anesthesia provider asked for the ETT and stopped once the ETT was placed through the glottis. The time was obtained from video recordings during the intubation by the principal investigator (PI).|Participants were followed for the duration of intubation, an average of 10 minutes|||Seconds||Standard Deviation|Mean
834094|NCT01263925|Secondary|Changes in Quality of Life (as Measured With the PAVK 86 Questionnaire) From Baseline to the End of Period 3|"Scores for subscales were calculated by summing non-missing item scores ranging from 1 (not at all; best possible outcome) to 4 (extremely; worst possible outcome) divided by the number of non-missing items. Hence each subscale score ranges from 1 (best possible outcome) to 4 (worst possible outcome). For subscales 'Mood' and 'Treatment expectation' five items each had to be reversed in order. Additionally, subjects were asked to assess their general health and quality of life on an ordinal scale between 0 (very good) and 10 (very poor).
Negative changes show a decrease from Baseline."|From Baseline to the end of 6-months Follow-up (Period 3)|Full Analysis Set (FAS). For each subscale of the questionnaire, Mean and SD are presented for non-missing values.||units on a scale||Standard Deviation|Mean
834708|NCT01272635|Secondary|Urgent Care Visits, ED Visits and Hospitalizations|Number of participants who had urgent care visits, ED visits, and/or hospitalizations for respiratory symptoms.|14 days after initiation of therapy|All participants who initiated APRIL therapy||participants|||Number
834095|NCT01263925|Secondary|Changes in Quality of Life (as Measured With the PAVK 86 Questionnaire) From Baseline to the End of Period 1|"Scores for subscales were calculated by summing non-missing item scores ranging from 1 (not at all; best possible outcome) to 4 (extremely; worst possible outcome) divided by the number of non-missing items. Hence each subscale score ranges from 1 (best possible outcome) to 4 (worst possible outcome). For subscales 'Mood' and 'Treatment expectation' five items each had to be reversed in order. Additionally, subjects were asked to assess their general health and quality of life on an ordinal scale between 0 (very good) and 10 (very poor).
Negative changes show a decrease from Baseline."|From Baseline to the end of 4 weeks of Daily Treatment (Period 1)|Full Analysis Set (FAS). For each subscale of the questionnaire, Mean and SD are presented for non-missing values.||units on a scale||Standard Deviation|Mean
834096|NCT01263925|Secondary|Ratio of Maximum Walking Distance After Period 3 in Comparison With the Findings After Period 2|The ratio of maximum walking distance was calculated by the maximum walking distance after Period 3 divided by the maximum walking distance after Period 2 with determination of maximum walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.|From the end of 4 weeks of Interval Treatment (Period 2) to the end of 6-months Follow-up (Period 3)|Full Analysis Set (FAS).||meter/meter||Standard Deviation|Mean
834097|NCT01263925|Secondary|Ratio of Maximum Walking Distance After Period 3 in Comparison With the Findings After Period 1|The ratio of maximum walking distance was calculated by the maximum walking distance after Period 3 divided by the maximum walking distance after Period 1 with determination of maximum walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.|From the end of 4 weeks of Daily Treatment (Period 1) to the end of 6-months Follow-up (Period 3)|Full Analysis Set (FAS).||meter/meter||Standard Deviation|Mean
834098|NCT01263925|Secondary|Ratio of Maximum Walking Distance After Period 3 in Comparison With the Findings at Baseline|The ratio of maximum walking distance was calculated by the maximum walking distance after Period 3 divided by the maximum walking distance at Baseline with determination of maximum walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.|From Baseline to the end of 6-months Follow-up (Period 3)|Full Analysis Set (FAS).||meter/meter||Standard Deviation|Mean
834099|NCT01263925|Secondary|Ratio of Maximum Walking Distance After Period 2 in Comparison With the Findings After Period 1|The ratio of maximum walking distance was calculated by the maximum walking distance after Period 2 divided by the maximum walking distance after Period 1 with determination of maximum walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.|From the end of 4 weeks of Daily Treatment (Period 1) to the end of 4 weeks of Interval Treatment (Period 2)|Full Analysis Set (FAS).||meter/meter||Standard Deviation|Mean
834100|NCT01263925|Secondary|Ratio of Maximum Walking Distance After Period 2 in Comparison With the Findings at Baseline|The ratio of maximum walking distance was calculated by the maximum walking distance after Period 2 divided by the maximum walking distance at Baseline with determination of maximum walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.|From Baseline to the end of 4 weeks of Interval Treatment (Period 2)|Full Analysis Set (FAS).||meter/meter||Standard Deviation|Mean
834101|NCT01263925|Secondary|Ratio of Maximum Walking Distance After Period 1 in Comparison With the Findings at Baseline|The ratio of maximum walking distance was calculated by the maximum walking distance after Period 1 divided by the maximum walking distance at Baseline with determination of maximum walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.|From Baseline to the end of 4 weeks of Daily Treatment (Period 1)|Full Analysis Set (FAS).||meter/meter||Standard Deviation|Mean
834102|NCT01263925|Secondary|Ratio of Pain-free Walking Distance After Period 3 in Comparison With the Findings After Period 2|The ratio of pain-free walking distance was calculated by the pain-free walking distance after Period 3 divided by the pain-free walking distance after Period 2 with determination of pain-free walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.|From the end of 4 weeks of Interval Treatment (Period 2) to the end of 6-months Follow-up (Period 3)|Full Analysis Set (FAS).||meter/meter||Standard Deviation|Mean
834103|NCT01263925|Secondary|Ratio of Pain-free Walking Distance After Period 3 in Comparison With the Findings After Period 1|The ratio of pain-free walking distance was calculated by the pain-free walking distance after Period 3 divided by the pain-free walking distance after Period 1 with determination of pain-free walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.|From the end of 4 weeks of Daily Treatment (Period 1) to the end of 6-months Follow-up (Period 3)|Full Analysis Set (FAS).||meter/meter||Standard Deviation|Mean
834132|NCT01274429|Primary|Determine Whether This Peanut OIT Protocol Lowers Their Risk of Anaphylactic Reactions and Causes Long-term Tolerance.|Assess mg of peanut tolerated on double-blind placebo-controlled food challenge as a measure of desensitization and tolerance|2-3 years|No subjects reached the end of study food challenge prior to closure of the study and therefore no data was collected towards this endpoint.|||||
834104|NCT01263925|Secondary|Ratio of Pain-free Walking Distance After Period 2 in Comparison With the Findings After Period 1|The ratio of pain-free walking distance was calculated by the pain-free walking distance after Period 2 divided by the pain-free walking distance after Period 1 with determination of pain-free walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.|From the end of 4 weeks of Daily Treatment (Period 1) to the end of 4 weeks of Interval Treatment (Period 2)|Full Analysis Set (FAS).||meter/meter||Standard Deviation|Mean
834105|NCT01263925|Primary|Ratio of Pain-free Walking Distance After Period 1 in Comparison With the Findings at Baseline|The ratio of pain-free walking distance was calculated by the pain-free walking distance after Period 1 divided by the pain-free walking distance at Baseline with determination of pain-free walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.|From Baseline to the end of 4 weeks of Daily Treatment (Period 1)|Full Analysis Set (FAS).||meter/meter||Standard Deviation|Mean
834106|NCT01263925|Primary|Ratio of Pain-free Walking Distance After Period 3 in Comparison With the Findings at Baseline|The ratio of pain-free walking distance was calculated by the pain-free walking distance after Period 3 divided by the pain-free walking distance at Baseline with determination of pain-free walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.|From Baseline to the end of 6-months Follow-up (Period 3)|Full Analysis Set (FAS).||meter/meter||Standard Deviation|Mean
834107|NCT01263925|Primary|Ratio of Pain-free Walking Distance After Period 2 in Comparison With the Findings at Baseline|The ratio of pain-free walking distance was calculated by the pain-free walking distance after Period 2 divided by the pain-free walking distance at Baseline with determination of pain-free walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.|From Baseline to the end of 4 weeks of Interval Treatment (Period 2)|Full Analysis Set (FAS).||meter/meter||Standard Deviation|Mean
834108|NCT01264016|Secondary|Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Comprehension)|Subjects reviewed the instructions for use (User Guide and Quick Reference Guide) to learn to use the system. Study staff then observed and rated the subjects (1 to 4) on their success at performing five tasks. Scale: 1.Success in performing tasks correctly without assistance. 2.Successful with additional review of User Guide. 3.Successful with additional review and study staff assist similar to review of a specific function during a Customer Service call. 4.Subject did not perform task correctly and study staff intervention was required.|2 hours|Per protocol||participants|||Number
834109|NCT01264016|Primary|Percent of Venous Blood Glucose (BG) Results Within +/- 5 to 20 mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method|Healthcare professionals (study staff) used an investigational blood glucose monitoring system (BGMS) with subject venous blood. BGM results were compared to a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were used to calculate the number of BG results within +/- 5 to 20 mg/dL (for reference BG results <75mg/dL) or +/- 5% to 20% (for reference BG results >=75mg/dL) of the reference method results.|2 hours|One subject's hematocrit measurement was missing, so this subject's blood test data was not evaluable. Since study staff tested each subject's venous blood using 2 lots of test strips, 2x93(or 186) test results were possible.||percentage of venous bg results|Participants||Number
834110|NCT01264016|Primary|Percent of Capillary Blood Glucose (BG) Results Within +/- 5 to 20mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method|Subjects with diabetes used an investigational blood glucose monitoring system (BGMS) with subject capillary blood. BGM results were compared to a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were used to calculate the number of BG results within +/- 5 to 20 mg/dL (for reference BG results <75mg/dL) or +/- 5 to 20% (for reference BG results >=75mg/dL) of the reference method results.|2 hours|One subject did not complete capillary blood testing (low blood sugar) and one subject hematocrit measurement was missing. These subjects' blood test data was not evaluable. Since the remaining 92 subjects tested 2 test strip lots on the BGM system, 2x92(184) tests results were possible.||percentage of BG Results|Participants||Number
834111|NCT01264081|Secondary|Count of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|3 years|Three study participants were affected by the adverse events: 2 - who completed the study and 1 who did not complete cycle 1 due to death of progressive disease. The participant who withdrew from study didn't take Lapatinib and experience any adverse events.||Participants|||Count of Participants
834112|NCT01264081|Primary|Count of Participants With a Partial Response (PR) and Complete Response (CR) to Lapatinib Who Have Metastatic Melanoma Harboring ERBB4 Mutations.|The count of participants with a partial response and complete response is defined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive disease (PD) is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The appearance of one or more new lesions is also considered progressions.|3 years|Only two participants could be evaluated for response and they had SD (none with a PR or CR). Other participants did not reach the evaluation point (i.e. discontinued Lapatinib)as per study protocol, therefore not evaluable.||Participants|||Count of Participants
834709|NCT01272635|Secondary|Absence From School, Daycare, and/or Parental Work||14 days after initiation of therapy|Data were of insufficient quality to be analyzed.|||||
834113|NCT01269736|Secondary|Patient Outcomes|Mortality, in-hospital MI, and not surviving a cardiac arrest were obtained using administrative data and laboratory data (eg, troponin, CK-MB) for all patients. Mortality was defined as death that occurred on one of the participating units. To identify the occurrence of in-hospital MI, laboratory data, timing of procedures, and location of patient at the time of the first blood draw indicating the event were used. Cardiac arrest was defined as an event initiated by an arrhythmia that required immediate intervention and was initiated on a PULSE participating unit. For each qualifying cardiac arrest, it was determined whether the patient survived the event.|Baseline, 15 months, 30 months|The overall number of unique patients reviewed at any timepoint. The numbers presented at each time point reflect the number of people reviewed at that time point for that outcome.||Participants|||Count of Participants
834114|NCT01269736|Secondary|Quality of Patient Care Related to ECG Monitoring|Percentage of patients with accurate electrode placement, accurate rhythm interpretation, cardiac arrest, cardiac arrest initiated by arrhythmia, appropriate monitoring, telemetry units only, ST-segment monitoring when indicated, and QTc measurement when indicated|Baseline, 15 months, 30 months|The overall number of unique patients assessed at any timepoint. The numbers presented at each time point reflect the number of people assessed at that time point.||Participants|||Count of Participants
834115|NCT01269736|Primary|Nurses' Knowledge and Skills Related to ECG Monitoring|Participants took a 20-item online test on essentials of ECG monitoring, and arrhythmia, ischemia, and QT interval monitoring. Scores represent the percentage of correct answers. (Test scores range from 0 to 100 with higher scores representing more correct answers)|Baseline, 15 months, 30 months|The overall number of unique nurses assessed at any timepoint. The numbers presented at each time point reflect the number of people assessed at that time point.||percentage of items correctly answered||Standard Deviation|Mean
834116|NCT01269801|Primary|Efficacy|"Assessments at Visits 3,5,6+7 (weeks 4,8,12,24) include:
-Physician Global Aesthetic Improvement Scale (PGAIS). Ratings include no change, improved, much improved, very much improved.
Number of subjects with improvement score for the 5 point PGAIS from baseline to Visit 7.
-Objective Observer Global Aesthetic Improvement Scale Number of subjects with improvement score for the from baseline to Visit 7. Ratings include no change, some improvement, definite improvement, substantial improvement, and complete improvement."|Week 4, 8, 12, 24|Analysis is based on the randomization group to account for the order in which the products were administered.||participantes rated improved and higher|||Number
834117|NCT01269918|Secondary|Postoperative Shivering|Indicator of whether patients had postoperative shivering.|Whether patients had postoperative or not, from anesthesia stop time until hospital discharge.|||participants|||Number
834118|NCT01269918|Secondary|Postoperative Vomitting|Indicator of whether patients had postoperative vomiting.|Whether patients had vomiting or not, from anesthesia stop time until hospital discharge.|||participants|||Number
834119|NCT01269918|Secondary|Postoperative Nausea|Indicator of whether patients had nausea or not|Whether patients had nausea or not, from anesthesia stop time until hospital discharge.|||participants|||Number
834120|NCT01269918|Secondary|End Case to Post Anesthesia Care Unit (PACU) Discharge|Post Anesthesia Care Unit (PACU) Discharge time is the timing at which patients are discharged from the PACU. This outcome is the amount of time (minutes) from end case to PACU discharge.|End case to post anesthesia care unit (PACU) discharge. Time is measured continuously until PACU discharge, regardless of how long it takes.|||minutes||Inter-Quartile Range|Median
834121|NCT01269918|Secondary|Drug Stop Time to Fitness to Discharge||Anesthesia drug stop time to fitness to discharge. Time is measured continuously until fitness for discharge is reached, regardless of how long it takes.|||minutes||Inter-Quartile Range|Median
834122|NCT01269918|Secondary|Drug Stop Time to Recall|Time between extubation until patients could say their names.|Time between extubation until patients could say their names.|||minutes||Inter-Quartile Range|Median
834123|NCT01269918|Secondary|Drug Stop Time to Open Eyes|time until patient first opened their eyes, squeezed a hand, or wiggled their toes in response to verbal commands after surgery|Anesthesia drug stop time to open eyes. Time is measured continuously until patients eyes open, regardless of how long it takes.|||minutes||Inter-Quartile Range|Median
834124|NCT01269918|Secondary|Nursing Workload Comparison|To evaluate the nurses workload when either of the two drugs are given in terms Nursing Research Usage form's therapeutic index scoring system. This score ranges from 0 (minimal interventions and time spent by nurses on study patient) to 22 (maximum interventions and time spent by nurses on the study patient).|90 minutes after extubation|||units on a scale||Inter-Quartile Range|Median
834125|NCT01269918|Secondary|Aldrete Score|The Aldrete score measured level of sedation and fitness and is used to assess the appropriate departure time from the post anesthesia care unit. The score ranges from 0 to 10, where 0 indicates poor fitness (and such patients are transferred to the ICU), while 10 indicates good fitness. This outcome was analyzed using a repeated measures ANOVA approach.|15, 30, 45, 60, and 90 minutes after extubation.|||units on a scale||Standard Deviation|Mean
834126|NCT01269918|Secondary|Modified Short Orientation Memory Concentration Test (SOMCT)|The Modified Short Orientation Memory Concentration Test (SOMCT) is a validated questionnaire that discriminates among mild, moderate, and severe cognitive deficits. SOMCT is based on 6 questions and produces a total score ranging from 0 (worst possible function) to 28 (best possible function). Scores > 20 are considered normal. This outcome was analyzed using a repeated measures ANOVA approach.|15, 30, 45, 60, and 90 minutes after extubation.|||units on a scale||Standard Deviation|Mean
834127|NCT01269918|Secondary|Heart Rate|Heart rate was determined from the arterial catheter and measured as beats per minute. This outcome was analyzed using a repeated measures ANOVA approach.|15, 30, 45, 60, and 90 minutes after extubation.|||beats per minute||Standard Deviation|Mean
834128|NCT01269918|Primary|Total Opioid Consumption|Total opioid consumption was defined as the sum of all opioid doses given within the first 90 minutes after surgery, converted to milligram morphine equivalents.|Initial 90 minutes of recover after surgery|||mg morphine equivalents||Inter-Quartile Range|Median
834129|NCT01269918|Primary|Postoperative Pain|Pain was measured using the visual analogue scale (VAS), where 0 is defined as no pain and 10 is defined as worst pain imaginable. This outcome was analyzed using a repeated measures ANOVA approach. In the outcome measure data table, mean ± standard deviation pain was reported as the aggregate mean across time points.|15, 30, 45, 60, and 90 minutes after extubation.|||units on a scale||Standard Deviation|Mean
834134|NCT01274533|Primary|Response Rate (CR + Cru + PR)|Peripheral blood, CT or MRI|28 days|The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in Aug. 2013.|||||
834135|NCT01274559|Secondary|Number of Participants Who Achieve LDL-C Target Levels at Week 12 of Treatment|assessed as per National Cholesterol Education Program (NCEP) Adult Treatment Panel III (ATP III) and European Society of Cardiology (ESC) treatment guidelines|Baseline and 12 weeks|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.|||||
834136|NCT01274559|Secondary|Percent Change From Baseline in TC at Week 4||Baseline and Week 4|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.|||||
834137|NCT01274559|Secondary|Percent Change From Baseline in Apo A-I at Week 4||Baseline and Week 4|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.|||||
834138|NCT01274559|Secondary|Percent Change From Baseline in Lp(a) at Week 4||Baseline and Week 4|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.|||||
834139|NCT01274559|Secondary|Percent Change From Baseline in TC:HDL-C at Week 4||Baseline and Week 4|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.|||||
834140|NCT01274559|Secondary|Percent Change From Baseline in Apo B:Apo A-I at Week 4||Baseline and Week 4|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.|||||
834141|NCT01274559|Secondary|Percent Change From Baseline in Apo B at Week 4||Baseline and Week 4|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.|||||
834142|NCT01274559|Secondary|Percent Change From Baseline in Non-HDL-C at Week 4||Baseline and Week 4|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.|||||
834143|NCT01274559|Secondary|Percent Change From Baseline in TG at Week 4||Baseline and Week 4|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.|||||
834144|NCT01274559|Secondary|Percent Change From Baseline in HDL-C at Week 4||Baseline and Week 4|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.|||||
834145|NCT01274559|Secondary|Percent Change From Baseline in LDL-C:HDL-C at Week 4||Baseline and Week 4|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.|||||
834146|NCT01274559|Secondary|Percent Change From Baseline in LDL-C at Week 4||Baseline and Week 4|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.|||||
834147|NCT01274559|Secondary|Percent Change From Baseline in TC at Week 12||Baseline and Week 12|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.|||||
834148|NCT01274559|Secondary|Percent Change From Baseline in Apo A-I at Week 12||Baseline and Week 12|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.|||||
834149|NCT01274559|Secondary|Percent Change From Baseline in Lipoprotein a [Lp(a)] at Week 12||Baseline and Week 12|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.|||||
834150|NCT01274559|Secondary|Percent Change From Baseline in Total Cholesterol (TC):HDL-C at Week 12||Baseline and Week 12|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.|||||
834151|NCT01274559|Secondary|Percent Change From Baseline in Apo B:Apolipoprotein A-I (Apo A-I) at Week 12||Baseline and Week 12|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.|||||
834152|NCT01274559|Secondary|Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 12||Baseline and Week 12|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.|||||
834153|NCT01274559|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12||Baseline and Week 12|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.|||||
834154|NCT01274559|Secondary|Percent Change From Baseline in Triglyceride (TG) at Week 12||Baseline and Week 12|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.|||||
834155|NCT01274559|Secondary|Percent Change From Baseline in HDL-C at Week 12||Baseline and Week 12|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.|||||
834156|NCT01274559|Secondary|Percent Change From Baseline in LDL-C:High-density Lipoprotein Cholesterol (HDL-C) at Week 12||Baseline and Week 12|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.|||||
834157|NCT01274559|Primary|Percent Change From Baseline at Week 12 in Low Density Lipoprotein-Cholesterol (LDL-C)||Baseline and Week 12|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.|||||
834158|NCT01274585|Secondary|Change in Fecal Incontinence Quality of Life (FIQoL) Score||4 weeks||||||
834159|NCT01274585|Secondary|Change in Fecal Incontinence Severity Index (FISI) Score||4 weeks||||||
834160|NCT01274585|Primary|Frequency of Fecal Incontinence|Patient kept 2 week bowel diary after completion of treatment. Bowel diary were collected to assess frequency of fecal incontinence in the two week span.|Diary kept for 14 days following treatment|||number of accidents||Full Range|Mean
834161|NCT01274611|Primary|Percentage Change of Sweat Rate (mg/Min) at Baseline Compared to 3 Months|"The primary outcome measure was the treatment associated unilateral axillary percentage change of sweat rate in milligrams per minute in the exercise-induced state measured at baseline compared with the sweat rate measured 3 months after treatment.
This process entails placing filter paper on the area of concern for a specific amount of time, after which the paper is weighed and sweat production is quantified in units of weight per time. The amount of sweat produced was recorded in milligrams per minute by subtracting the initial weight of the paper segment before exercise from the final, post-application weight, after exercise and dividing by 5 minutes.
Percentage sweat rate was calculated as [(sweat rate at baseline - sweat rate at 3 months)/sweat rate at baseline]*100 with a positive percent change indicating sweat rate reduction if the baseline had a higher sweat rate."|baseline and 3 months|||Percentage Change|Participants|Full Range|Mean
834162|NCT01274611|Secondary|The Change in Hyperhidrosis Disease Severity Scores From Baseline Compared to 3 Months After Treatment|"Change in mean score on the Hyperhidrosis Disease Severity Scale (HDSS) from baseline minus 3 months after treatment.
The HDSS iquestionnaire assigns a point value to the patient’s view:
My sweating is...
never noticeable and never interferes with my daily activities
tolerable but sometimes interferes with my daily activities
barely tolerable and frequently interferes with my daily activities
intolerable and always interferes with my daily activities
Lower point values are considered better and higher point values are considered worse.
A larger change in score between baseline and 3 months is considered a better outcome and a smaller change in score is considered a worse outcome for each treatment. Change scores were calculated (baseline minus 3 months). Positive change scores indicate that scores were better; negative change scores indicate their scores were worse after treatment."|Baseline and 3 months|||Scores on a scale|Participants|Standard Deviation|Mean
834163|NCT01274637|Secondary|Heparin Induced Thrombocytopenia|All subjects who develop thrombocytopenia (platelets less than 80 x 109/L and/or with >50% decrease from baseline) will be investigated for Heparin Induced Thrombocytopenia (HIT) by having ELISA and serotonin release assays to confirm or refute a diagnosis of HIT. HIT will be diagnosed with a positive PF4 (platelet factor 4) HIT ELISA assay.|From Randomization to Day 90|||Participants|||Count of Participants
834164|NCT01274637|Secondary|Major Bleeding or Clinically Relevant Non-major Bleeding|"Major bleeding meets at least one of the following: Fatal bleeding; Symptomatic bleeding in a critical area or organ (intracranial, intraspinal, retroperitoneal, etc.); Bleeding causing a fall in hemoglobin level of 20 g L−1 (1.24 mmol L−1) or more, or leading to transfusion of two or more units of whole blood or red cells .
Clinically Relevant Non-major Bleeding does not meet the criteria for major bleeding but meets at least one of the following: Hospitalization; Medical intervention; Unscheduled contact with a physician; Discomfort (pain, or impairment of activities of daily life)."|From Randomization to Day 90|||Participants|||Count of Participants
834165|NCT01274637|Secondary|Death From Venous Thromboembolism|"If a subject dies between randomization and late postpartum follow up (Day 90 +/- 7 days) the death will be adjudicated as certain, highly probable, probable, or unlikely due to Pulmonary Embolism (PE) using the following criteria.
Certain: hypotension, hypoxia, cardiac arrest with no other explanation other than PE and autopsy or radiographic confirmation Highly probable: criteria for certain but another disease could have caused the death Probable: other cause suspected based on clinical evidence but 100% certainty not available Unlikely: all other cases."|From Randomization to Day 90|||Participants|||Count of Participants
834166|NCT01274637|Secondary|Late Symptomatic Venous Thromboembolism|This includes symptomatic Deep Vein Thrombosis or Pulmonary Embolism. Suspected outcomes will be adjudicated by a blinded adjudication committee.|From Day 10 to Day 90|||Participants|||Count of Participants
834167|NCT01274637|Secondary|Venous Thromboembolism in the Early Postpartum Period.|This includes symptomatic Deep Vein Thrombosis (DVT) or pulmonary embolism (PE) in the interval between randomization and the last dose of study drug (10 days +/- 3 days) OR asymptomatic proximal DVT detected by compression ultrasound of both legs done within 24hrs of the last dose of study drug (10 days (+/- 3 days) postpartum). Compressed and non-compressed images will be obtained from the calf trifurcation to the inguinal ligament. All suspected outcomes will be adjudicated by a blinded expert adjudication committee.|From randomization to Day 10|||Participants|||Count of Participants
834168|NCT01274637|Primary|Feasibility of Recruitment and Trial Operations.|The average number of subjects that are recruited per site per month during a 4 month active recruitment phase at each site.|4 months|||participants per site per month|||Number
834169|NCT01274715|Primary|Change in Hemoglobin A1C|Value of Hemoglobin A1C reduction post-intervention. The coaching sessions take place over approximately 3 months -- outcomes are measured at baseline, 3 months and again at 6 months. Change from baseline to 3 months was calculated. Then change from baseline to 6 months was calculated.|baseline, 3 months, and 6 months|||percentage of glycated hemoglobin||Standard Deviation|Mean
834170|NCT01274715|Primary|Change in PHQ-9 (Patient Health Questionnaire-9)Scores|The full name of the measure is the Patient Health Questionnaire-9. This is a self-reported measure of depressive symptoms. This is a nine item measure with a response for each item between 0-3. Total scores on this measure range from 0-27, with 0 being a minimum indicating no depressive symptoms, and 27 being the maximum number and severity of depressive symptoms. The coaching sessions take place over approximately 3 months -- outcomes are measured at baseline, 3 months and again at 6 months. Change from baseline to 3 months was calculated. Then change from baseline to 6 months was calculated.|Baseline, 3 months, and 6 months|||scores on a scale||Standard Deviation|Mean
834171|NCT01274897|Secondary|Number of Subjects Who Reported Local and Systemic Reactogenicity During 7 Days After MenACWY-CRM Vaccination||during 7 days of vaccination|Analysis was done on safety population i.e. the subjects in the exposed population who provided post-baseline safety data.||Subjects|||Number
834172|NCT01274897|Secondary|Percentages of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination.|Immunogenicity was measured as the percentage of subjects with hSBA titer ≥1:8 and associated 95% CI, at baseline before vaccination (day 1) and at day 29 (28 days after MenACWY-CRM vaccination).|day 1 and day 29|Analysis was done on PP population.||Percentages of subjects||95% Confidence Interval|Number
834173|NCT01274897|Secondary|Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination.|Immunogenicity was assessed as hSBA GMTs and associated 95% CI, measured against N. meningitidis serogroups A, C, W and Y, before the vaccination (baseline, day 1) and at day 29 (28 days after MenACWY-CRM vaccination).|day 1 and day 29|Analysis was done on PP population.||Titers||95% Confidence Interval|Geometric Mean
834174|NCT01274897|Primary|Percentages of Subjects With Seroresponse, Directed Against Neisseria Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination.|"Immunogenicity was measured as the percentage of subjects with hSBA response and associated 95% Clopper-Pearson confidence interval (CI), directed against N. meningitidis serogroups A, C, W and Y by serum bactericidal assay using human complement, human serum bactericidal assay (hSBA), at day 29 (28 days after MenACWY-CRM vaccination).
Seroresponse is defined as:
for subjects with a pre-vaccination hSBA titer < 1:4, a postvaccination hSBA titer ≥ 1:8.
for subjects with a pre-vaccination hSBA titer ≥ 1:4, an increase in hSBA titer of at least four times the pre-vaccination titer."|day 29|Analysis was done on per protocol (PP) population i.e. the subjects who received the vaccine correctly and provided evaluable serum samples at the relevant time points.||Percentages of subjects||95% Confidence Interval|Number
834176|NCT01275066|Secondary|Percent Change From Baseline in Urine Keratan Sulfate Normalized for Urine Creatinine||Baseline to Week 24|Intention to treat (all patients receiving at least one dose of study drug). Nine missing outcomes at Week 24 were imputed using method of multiple imputation.||percent change||Standard Deviation|Mean
834177|NCT01275066|Secondary|Change From Baseline in Endurance as Measured by the 3-minute Stair Climb Test||Baseline to Week 24|Intention to treat (all patients receiving at least one dose of study drug). Two missing outcomes at Week 24 were imputed using method of multiple imputation.||stairs/minute||Standard Deviation|Mean
834178|NCT01275066|Primary|Change From Baseline in Endurance as Measured by the 6-minute Walk Test||Baseline to Week 24|Intention to treat (all patients receiving at least one dose of study drug). Two missing outcomes at Week 24 were imputed using method of multiple imputation.||meters||Standard Deviation|Mean
834179|NCT01275092|Secondary|The Ratio Between the Radiation Exposure of the Primary Operator and the Radiation Exposure at the Table|Defined as the difference between the radiation exposure measured at the procedure table (the conventional site of the primary operator) and the radiation exposure measured at the primary operator's position during the procedure. The radiation unit that was used was in milligray, but the measure is being reported as the ratio.|1 day|||ratio||Inter-Quartile Range|Median
834180|NCT01275092|Primary|Percentage of Patients With Device Technical Success|Defined as the successful advancement and retraction of PCI devices using the CorPath 200 System and without conversion to manual operation.|1 day|||percentage of participants||95% Confidence Interval|Number
834181|NCT01275092|Primary|Percentage of Participants With Clinical Procedural Success|Defined as <30% residual stenosis in CorPath 200 System treated lesions at the completion of the interventional procedure (including stent placement) in the absence of MACE, either within 48 hours of the procedure or prior to hospital discharge, whichever occurs first.|48-hrs or hospital discharge, whichever occurs first|||percentage of participants||95% Confidence Interval|Number
834182|NCT01275131|Secondary|Duration of Insulin Action (AUMC[0-360]/AUC[0-360]), Stage 3|Duration of insulin action was calculated by dividing the area under the first moment curve (AUMC[0-360]) by the area under the concentration versus time curve (AUC[0-360]) for Stage 3. Blood samples were collected 10 minutes predose and at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|10 minutes predose up to 360 minutes postdose on Days 2/7, 3/8, and 5/10|Participants who completed all periods of study within a given stage with evaluable AUMC(0-360)/AUC(0-360) data.||ratio||Standard Deviation|Mean
834183|NCT01275131|Secondary|Duration of Insulin Action (AUMC[0-360]/AUC[0-360]), Stage 1|Duration of insulin action was calculated by dividing the area under the first moment curve (AUMC[0-360]) by the area under the concentration versus time curve (AUC[0-360]) for Stage 1. Blood samples were collected 10 minutes predose and at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|10 minutes predose up to 360 minutes postdose on Day 2/6 and Day 4/8|Participants who completed all periods of study within a given stage with evaluable AUMC(0-360)/AUC(0-360) data.||Ratio||Standard Deviation|Mean
834184|NCT01275131|Secondary|Area Under the Glucose Concentration Curve (AUC[0-360]), Stage 3|Area under the glucose concentration curve from 0 to 360 minutes (AUC[0-360]) for Stage 3 studies is presented. Blood samples were collected 30 and 10 minutes prior to insulin bolus and at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|30 minutes predose up to 360 minutes postdose Days 2/7, 3/8, and 5/10|Participants who completed all periods of study within a given stage with evaluable AUC(0-360) data.||Picomoles*minutes/liter||Standard Deviation|Mean
834185|NCT01275131|Secondary|Area Under the Glucose Concentration Curve (AUC[0-360]), Stage 1|Area under the glucose concentration curve for 0 to 360 minutes (AUC[0-360]) from Stage 1 is presented. Blood samples were collected 30 and 10 minutes prior to insulin bolus and at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|30 minutes predose up to 360 minutes postdose on Day 2/6 and Day 4/8|Participants who completed all periods of study within a given stage with evaluable AUC(0-360) data.||Picomoles*minutes/liter||Standard Deviation|Mean
834186|NCT01275131|Secondary|Time to 50% Total Glucose Infused (50%Gtot), Stage 3|Time to 50% of total glucose infused (50%Gtot) is presented for Stage 3. Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|0 up to 360 minutes postdose on Days 2/7, 3/8, and 5/10|Participants who completed all periods of study within a given stage with evaluable 50%Gtot data.||Minutes||Standard Deviation|Mean
834187|NCT01275131|Secondary|Time to 50% Total Glucose Infused (50%Gtot), Stage 1|Time to 50% total glucose infused (50%Gtot) is presented for Stage 1. Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|0 up to 360 minutes postdose on Day 2/6 and Day 4/8|Participants who completed all periods of study within a given stage with evaluable 50%Gtot data.||Minutes||Standard Deviation|Mean
834188|NCT01275131|Secondary|Time to 50% Maximum Glucose Infusion Rate (tGIR50%Max), Stage 3|Early and late time to 50% maximum glucose infusion rates (tGIR50%max) for Stage 3 studies are presented. Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|0 up to 360 minutes postdose on Days 2/7, 3/8, and 5/10|Participants who completed all periods of study within a given stage with evaluable early and late tGIR50%max data.||Minutes||Standard Deviation|Mean
834223|NCT01275625|Secondary|Immunological Response at Week 48: Percentage Change From Baseline in Absolute Cluster of Differentiation 8 (CD8)|Immunological Response was summarized using percentage change from Baseline to Week 48 in absolute CD8+ cell count.|Week 48|FAS Population included those participants who had taken at least 1 dose of the study drug.||Percent||Standard Deviation|Mean
834189|NCT01275131|Secondary|Time to 50% Maximum Glucose Infusion Rate (tGIR50%Max), Stage 1|Early and late times to 50% maximum glucose infusion rate (tGIR50%max) for Stage 1 are presented. Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|0 up to 360 minutes postdose on day 2/6 and Day 4/8|Participants who completed all periods of study within a given stage with evaluable early or late tGIR50%max data.||Minutes||Standard Deviation|Mean
834190|NCT01275131|Secondary|Time to First Occurrence of Maximum Glucose Infusion Rate (tGIRmax), Stage 3|Time to first occurrence of maximum glucose infusion rate (tGIRmax) for Stage 3 is presented. Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|0 up to 360 minutes postdose on Days 2/7, 3/8, and 5/10|Participants who completed all periods of study within a given stage with evaluable tGIRmax data.||Minutes||Standard Deviation|Mean
834191|NCT01275131|Secondary|Time to First Occurrence of Maximum Glucose Infusion Rate (tGIRmax), Stage 1|Time to first occurrence of maximum glucose infusion rate (tGIRmax) for Stage 1 is presented. Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|0 up to 360 minutes postdose on Day 2/6 and Day 4/8|Participants who completed all periods of study within a given stage with evaluable tGIRmax data.||Minutes||Standard Deviation|Mean
834192|NCT01275131|Secondary|Maximum Glucose Infusion Rate (GIRmax), Stage 3|Maximum glucose infusion rates (GIRmax) for Stage 3 are presented. Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|0 up to 360 minutes postdose on Days 2/7, 3/8, and 5/10|Participants who completed all periods of study within a given stage with evaluable GIRmax data.||Milligrams/kilogram/minute||Standard Deviation|Mean
834193|NCT01275131|Primary|Early Exposure to Insulin (%AUC[0-60]), Stage 3|Early insulin exposure, defined as the percentage of total insulin exposure (area under the insulin concentration curve [AUC{0-360}) that occurs within the first hour following bolus dose of insulin during the 2 euglycemic clamps is presented. Blood samples were collected 10 minutes predose and at 0, 5, 10, 15, 20, 30, 45, 60, 120, 150, 180, 240, 300, and 360 minutes postdose during the euglycemic clamp.|10 minutes predose up to 60 minutes postdose on Days 2/7, 3/8, and 5/10|Participants who completed all periods of study within a given stage with evaluable %AUC(0-60) data.||Percentage of AUC(0-360)||Standard Deviation|Mean
834194|NCT01275131|Secondary|Maximum Glucose Infusion Rate (GIRmax), Stage 1|Maximum glucose infusion rates (GIRmax) for Stage1 are presented. Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|0 up to 360 minutes postdose on Day 2/6 and Day 4/8|Participants who completed all periods of study within a given stage with evaluable GIRmax data.||Milligrams/kilogram/minute||Standard Deviation|Mean
834195|NCT01275131|Primary|Early Insulin Exposure (%AUC[0-60]), Stage 1|Early insulin exposure, defined as the percentage of total insulin exposure (area under the insulin concentration curve [AUC{0-360}]) that occurs within the first hour following bolus dose of insulin during the 2 euglycemic clamps is presented. Blood samples were collected 10 minutes predose and at 0, 5, 10, 15, 20, 30, 45, 60, 120, 150, 180, 240, 300, and 360 minutes postdose during the euglycemic clamp.|10 minutes predose up to 60 minutes postdose|Participants who completed all study periods within a given stage with evaluable early insulin exposure (%AUC[0-60]) data.||Percentage of AUC(0-360)||Standard Deviation|Mean
834196|NCT01275196|Secondary|Summary Statistics of Trough Imatinib and Major Metabolite CGP74588 of Imatinib and Nilotinib PK Concentration by Time Point|Pharmacokinetic Analysis Set|12 Months|Pharmacokinetic Analysis Set||ng/mL||Standard Deviation|Mean
834197|NCT01275196|Secondary|Actual Dose Intensity|Total dose/time on treatment (periods of zero dose were included).|End of Study (up to 40 months)|Safety set consisted of all randomized patients who received at least one dose of study medication.||mg/day||Standard Deviation|Mean
834198|NCT01275196|Secondary|Modified ELN2009 Criteria|Patients satisfying criteria for several “modified ELN 2009” categories are presented once under the worst category (Optimal> Suboptimal > Treatment failure). Patients in the “Discontinued” category are those who discontinued before the time point considered without satisfying any of the ELN 2009 criteria. Patients in the “Missing” category are those ongoing in the trial at the time point considered but with only missing or non evaluable data for ELN 2009 criteria.|End of Study (up to 40 months)|Patients in the FAS consisted of all patients who were randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment group to which they were assigned at randomization.||Percentage of Participants|||Number
834199|NCT01275196|Secondary|Best Complete Hematologic Response (CHR)|CHR was defined as having all of the following criteria present at any assessment, which was confirmed by another assessment at least after 4 weeks: • WBC count < 10 x 10E9 /L • Platelet count < 450 x 10E9 /L • Basophils < 5% • No blasts and promyelocytes in peripheral blood • Myelocytes + metamyelocytes < 5 % in peripheral blood • No evidence of extramedullary involvement. The assessment was not considered CHR, if there were any values indicative of CML in AP or BC (i.e. by blasts in bone marrow). For confirmation of CHR, both the initial CHR as well as the confirming assessment (at least 4 weeks after the initial assessment) had to satisfy all criteria mentioned above, without any assessment in between which indicated ‘No response’.|Months 1, 3, 4, 5, 6, 9,12, 15,18, 21, 24, 30, 36|Patients in the FAS consisted of all patients who were randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment group to which they were assigned at randomization.||Percentage of participants||95% Confidence Interval|Number
834200|NCT01275196|Secondary|Kaplan-Meier Estimates of Overall Survival (OS) on Treatment|Patients who discontinued study treatment early or completed the study protocol and did not enter into the extension protocol were to be followed for survival every 3 months for up to 2 calendar years from the date the last patient randomized received the first dose of study drug and every 6 months until Last Patient Last Visit. Overall survival (all deaths) was defined as the time between date of randomization and date of death due to any cause at any time during the study, including the follow-up period after discontinuation of treatment, i.e. overall survival on-study. The time was censored at the date of last assessment in the study for patients who are still being treated and at the date of last contact for patients who discontinued treatment.|End of Study (up to 40 months)|Patients in the FAS consisted of all patients who were randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment group to which they were assigned at randomization.||Months||95% Confidence Interval|Median
834201|NCT01275196|Secondary|Kaplan-Meier Estimates of Progression-free Survival (PFS) on Treatment|"Progression-free survival was defined as the time from the date of randomization to the date of event defined as the first disease progression to AP/BC or the date of death from any cause, whichever is earlier. This variable was analyzed in 2 ways:
On-treatment: included progressions to AP/BC or deaths occurring only on-treatment in the study as events. The time was censored at the date of last on-treatment assessment (hematology, extramedullary disease or cytogenetic evaluation) in the study before the cut-off date of the analysis for patients without event.
On-study: included progressions to AP/BC or deaths occurring in the study or during the follow-up period after discontinuation of study treatment as events. The time was censored at the last assessment date in the study for patients who were still being treated and at the date of last contact for patients who discontinued treatment."|End of study (up to 40 months)|Patients in the FAS consisted of all patients who were randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment group to which they were assigned at randomization.||Months||95% Confidence Interval|Median
834202|NCT01275196|Secondary|Kaplan-Meier Estimates of Event-free Survival (EFS) on Treatment|Event-free survival was defined as the time from the date of randomization to the date of first occurrence of any of the following:-Death due to any cause, - Progression to AP or BC, Loss of partial cytogenetic response (PCyR), - Loss of CCyR, - Loss of CHR|End of Study (up to 40 months)|Patients in the FAS consisted of all patients who were randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment group to which they were assigned at randomization.||Months||95% Confidence Interval|Median
834203|NCT01275196|Secondary|Kaplan-Meier Estimates of Time to Progression to Accelerated Phase/Blast Crisis (AP/BC) on Treatment|"Time to progression to AP/BC was defined as the time from the date of randomization to the date of event defined as the first disease progression to AP/BC or the date of CML-related death, whichever is earlier. This variable was analyzed in 2 ways:
On-treatment: included progressions to AP/BC or CML-related deaths occurring on treatment in the study as events. The time was censored at the date of last on-treatment assessment (hematology, extramedullary disease, or cytogenetic evaluation) in the study for patients without event.
On-study: included progressions to AP/BC or CML-related deaths occurring in the study or during the follow-up period after discontinuation of treatment as events. The time was censored at the last assessment date in the study for patients who were still being treated and at the date of last contact for patients who discontinued treatment"|End of study (up to 40 months)|Patients in the FAS consisted of all patients who were randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment group to which they were assigned at randomization||Months||95% Confidence Interval|Median
834204|NCT01275196|Secondary|Kaplan-Meier Estimates of Duration of First CCyR Among Patients Who Achieved CCyR|Duration of CCyR (months) = (date of CCyR loss or censoring-date of first CCyR + 1)/30.4375|End of Study (up to 40 months)|Patients in the FAS consisted of all patients who were randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment group to which they were assigned at randomization||Months||95% Confidence Interval|Median
834205|NCT01275196|Secondary|Kaplan-Meier Estimates of Time to First CCYR|Time to first CCyR (months) = (date of first CCyR – date of randomization + 1) / 30.4375.|End of study (up to 40 months)|Patients in the FAS consisted of all patients who were randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment group to which they were assigned at randomization.||months||95% Confidence Interval|Median
834206|NCT01275196|Secondary|Best Complete Cytogenic Response (CCyR) Rate by Each Time Point|CCyR is defined as 0% Ph+ metaphases based on at least 20 metaphases from bone marrow cytogenetics.|Months 6, 12, 18, 30, 24, 36|Patients in the FAS consisted of all patients who were randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment group to which they were assigned at randomization.||Percentage of Participants||95% Confidence Interval|Number
834207|NCT01275196|Secondary|Kaplan-Meier Estimates of Duration of First MMR Among Patients Who Achieved MMR|Duration of first MMR (months) = (date of loss of MMR or censoring-date of first MMR + 1)/30.4375.|End of Study (Up to 40 months)|Patients in the FAS consisted of all patients who were randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment group to which they were assigned at randomization.||Months||95% Confidence Interval|Median
834208|NCT01275196|Secondary|Durable MMR Rate at 24 Months|The rate of durable MMR at 24 months, defined as the proportion of patients who have achieved MMR at 12 months, and also maintain continuous MMR until the 24 month time point (1 month = 28 days) without intervening loss of MMR in between 12 and 24 months|24 months|Patients in the FAS consisted of all patients who were randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment group to which they were assigned at randomization.||Perentage of Participants||95% Confidence Interval|Number
834209|NCT01275196|Secondary|Kaplan-Meier Estimates of Time to First MMR|Time to first MMR (months) = (date of first MMR or censoring – date of randomization + 1) / 30.4375.|End of study (up to 40 months)|Patients in the FAS consisted of all patients who were randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment group to which they were assigned at randomization.||months||95% Confidence Interval|Median
834210|NCT01275196|Secondary|Best MMR by Each Timepoint|Best MMR rates by scheduled time point are cumulative response rates up to that time point. In this analysis, patients who had achieved MMR at or before the time point were counted as responders, no matter if they lost the response/discontinued or not. Therefore, this response rate represented the best observed response rate up to that specific time point.|Months 3,6,9,12,15, 18, 21, 24, 36|Patients in the FAS consisted of all patients who were randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment group to which they were assigned at randomization.||Percentage of Participants||95% Confidence Interval|Number
834224|NCT01275625|Secondary|Immunological Response at Week 48: Absolute Change From Baseline in Absolute Cluster of Differentiation 8 (CD8)|Immunological Response was summarized using absolute change from Baseline to Week 48 in absolute CD8+ cell count.|Week 48|FAS Population included those participants who had taken at least 1 dose of the study drug.||cells/mcL||Standard Deviation|Mean
834783|NCT01272947|Primary|Pain on Movement|"Visual analog scale (VAS) assessed on a 100 mm scale with anchors at 0= No pain and 100= Extreme pain"|VAS Score at 24 hours|||mm||Standard Deviation|Mean
834211|NCT01275196|Secondary|MMR Rate at Each Time Point|Major molecular response (MMR) was defined as a value of ≤ 0.1% of BCR-ABL ratio on the IS. The minimum number of control genes for a sample to be valid was 3000. For statistical comparison purpose, MMR was considered as a binary variable with patients achieving MMR grouped as ‘responders’ and patients not achieving MMR, patients with missing PCR evaluations or patients with atypical transcripts at baseline grouped as ‘non-responders’. These time points including the 12 month data were calculated based on the final analysis after the end of the study.|Months 3,6,9,12,15, 18, 21, 24, 36|Patients in the FAS consisted of all patients who were randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment group to which they were assigned at randomization.||Percentage of Participants||95% Confidence Interval|Number
834212|NCT01275196|Primary|Major Molecular Response (MMR) at 12 Months - With Imputation.|Major molecular response (MMR) was defined as a value of ≤ 0.1% of BCR-ABL ratio on the IS. The minimum number of control genes for a sample to be valid was 3000. For statistical comparison purpose, MMR was considered as a binary variable with patients achieving MMR grouped as ‘responders’ and patients not achieving MMR, patients with missing PCR evaluations or patients with atypical transcripts at baseline grouped as ‘non-responders’. This endpoint was calculated based on the 12 month analysis.|12 months|Patients in the FAS consisted of all patients who were randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment group to which they were assigned at randomization.||Percentage of Participants||95% Confidence Interval|Number
834213|NCT01275313|Primary|Incidence of a Sitting-induced Pressure Ulcer|Skin assessments for incidence of sitting-induced pressure ulcer will occur once per week until occurrence of a pressure ulcer or 180 days|182 days|||Participants|||Count of Participants
834214|NCT01275430|Secondary|Phase I: Amount of PICC Tip Movement When the Subject’s Arm is Adducted From a 90° Position to the Subject’s Side.|"Mean distance (mm) of PICC tip movement when the subject’s arm is adducted from a 90° position to the subject’s side, by directly measuring the distance from the catheter tips to the parts of the CAJ (upper, middle, and lower) with the subject's arm at 90°and compared to the PICC tip with the subject's arm at the side .
All subjects were assigned to Sherlock 3CG in Phase I. Randomization was to have occurred in Phase II, but Phase II was not initiated due to termination of the study."|Day 0|||mm||Standard Deviation|Mean
834215|NCT01275430|Secondary|Phase I: Change in Distance (mm) Between the Location of the Cavoatrial Junction When Angiographic CT is Performed With the Arms Above the Head vs at the Subject’s Side.|"Measurements (mm) of the location of the cavoatrial junction on Angiographic CT to evaluate shift greater than 5mm in mediastinal structures between ACT acquisitions obtained with the arms above the head vs arms at side of body (90°).
All subjects were assigned to Sherlock 3CG in Phase I. Randomization was to have occurred in Phase II, but Phase II was not initiated due to termination of the study."|Day 0|||mm||Standard Deviation|Mean
834216|NCT01275430|Secondary|Number of Participants With Acceptable Angiographic CT Visualization of the PICC Tip When Using Sherlock 3CG for PICC Placement|"Proportion of acceptable visualization of the PICC tip location when maximum p-wave amplitude is observed.
Note – this endpoint is to assess the diagnostic capability of Angiographic Computed Tomography (ACT). It is not designed to reflect on PICC tip location.
All subjects were assigned to Sherlock 3CG in Phase I. Randomization was to have occurred in Phase II, but Phase II was not initiated due to termination of the study."|Day 0|||participants|||Number
834217|NCT01275430|Secondary|Phase I: Distance Necessary for Repositioning of the PICC Tip Upon Observation of the Maximum P-wave Amplitude, if Necessary.|"Distance (mm), if any, that is required to move the PICC tip upon observation of the maximum p-wave amplitude in order to have the PICC tip at the upper cavoatrial junction. Direct measurement of distance from the catheter tips to the parts of the CAJ
All subjects were assigned to Sherlock 3CG in Phase I. Randomization was to have occurred in Phase II, but Phase II was not initiated due to termination of the study."|Day 0|||mm||Standard Deviation|Mean
834218|NCT01275430|Primary|Phase I - Location of the PICC Tip Upon Observation of Maximum P-wave Amplitude Using Sherlock 3CG.|"Mean distance (mm) from the PICC tip to the upper cavoatrial junction (CAJ) upon observation of maximum p-wave amplitude when using Sherlock 3CG.
All subjects were assigned to Sherlock 3CG in Phase I. Randomization was to have occurred in Phase II, but Phase II was not initiated due to termination of the study."|Time of PICC placement (Day 0)|||mm||Standard Deviation|Mean
834219|NCT01275586|Primary|Disease Response|To estimate the disease control rate (PD,SD, PR, CR) with Tasigna® in patients with neurofibromas (NF1) using standard RECIST criteria. Complete Response (CR) is defined as; disappearance of all target lesions. Partial Response (PR) is defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as a reference the baseline sum longest diameter. Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started. Disease Progression (PD) is defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.|6 months|||Participants|||Count of Participants
834220|NCT01275625|Secondary|Number of Participants With HIV-1 RNA Tropism Status Using Genotyping Assay at Screening and at the Time of Virologic Failure.|Change in tropism were summarized at the time of treatment failure or Early Termination (note: this was performed for participants with viral load > 400 copies/mL only).|Screening to Week 48 or Time of treatment Failure|All participants who discontinued therapy early or who reached Week 48 with sufficient plasma HIV 1 RNA for analysis (500 copies/mL) were included in the analysis.||Participants|||Number
834221|NCT01275625|Secondary|Number of Participants With Genotypic Resistance.|The viral genotypes were captured at Baseline and at treatment failure or Early termination and any resistance-associated mutations summarized descriptively at Week 48 for the Nucleotide reverse transcriptase inhibitors (NRTIs), and non-NRTIs (NNRTIs)drug classes.|Screening to Week 48 or Time of treatment Failure|All participants who discontinued therapy early or who reached Week 48 with sufficient plasma HIV 1 RNA for analysis (500 copies/mL) were included in the analysis.||Participants|||Number
834222|NCT01275625|Secondary|Immunological Response at Week 48: Change From Baseline in Absolute Cluster of Differentiation 4 (CD4)/ Cluster of Differentiation 8 (CD8) Ratio.|Immunological Response was summarized using absolute change from Baseline to Week 48 in absolute CD4+/ CD8+ ratio.|Week 48|FAS Population included those participants who had taken at least 1 dose of the study drug.||Ratio||Standard Deviation|Mean
834227|NCT01275625|Secondary|Virologic Response: Rate of Virologic Failure at Week 48.|Virologic failure defined as: failure to achieve a reduction from baseline in HIV 1 RNA ≥ 0.5 log10 copies /mL by the second viral load determination (unless viral load was below the lower limit level of quantification [LLOQ]); or a ≥ 0.5 log10 increase from nadir in HIV 1 RNA after achieving a HIV 1 RNA reduction from BL >0.5 log10 copies/mL; or a HIV 1 RNA level of >1000 copies/mL after having achieved a HIV 1 RNA level below LLOQ. Participants with Time to loss of virologic response (defined by level of <50 copies/mL) failure were classified as rebounders or non-responders.|48 weeks|FAS Population included those participants who had taken at least 1 dose of the study drug.||Participants|||Number
834228|NCT01275625|Secondary|Virologic Response: Percentage of Participants With Plasma HIV-1 RNA Load < 400 Copies/mL at Post-baseline Visits.|Participants’ responder status at Week 48 was assessed according to MDF algorithm. This algorithm treats all participants with HIV 1 RNA data missing at the time of interest or discontinuation of study drug as failures or non responders.|Baseline, Week 4, Week 8, Week 12, Week 20, Week 24, Week 36 and Week 48|FAS Population included those participants who had taken at least 1 dose of the study drug.||Percentage of participants|||Number
834229|NCT01275625|Secondary|Virologic Response: Percentage of Participants With Plasma HIV-1 RNA Load <50 Copies/mL at Post-baseline Visits.|Participants’ responder status at Week 48 was assessed according to MDF algorithm. This algorithm treats all participants with HIV 1 RNA data missing at the time of interest or discontinuation of study drug as failures or non responders.|Baseline, Week 4, Week 8, Week 12, Week 20, Week 24, Week 36 and Week 48|FAS Population included those participants who had taken at least 1 dose of the study drug.||Percentage of participants|||Number
834230|NCT01275625|Primary|Percentage of Participants With Plasma Human Immuno Deficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) Load <50 Copies/Milliliter (mL) at 48 Weeks.|Participants’ responder status at Week 48 was assessed according to Missing, discontinuation= Failure (MDF) algorithm. This algorithm treats all participants with HIV 1 RNA data missing at the time of interest or discontinuation of study drug as failures or non responders.|48 weeks|Full Analysis Set (FAS) Population included those participants who had taken at least 1 dose of the study drug.||Percentage of participants||95% Confidence Interval|Number
834231|NCT01275755|Primary|Change From Baseline in the Weekly Average of Spontaneous Bowel Movements (SBMs) During Treatment|An SBM was defined as a bowel movement (BM) with no laxative use in the previous 24 hours. Each weekly SBM average was calculated as follows: (7 × number of SBMs) / (number of days with nonmissing data). The overall SBM rate for the 4-week double-blind treatment period was calculated as follows: (the average of the first week + the average of the second week + the average of the third week + the average of the fourth week) / 4.|Baseline, Weeks 1 through 4 of treatment|All participants who were randomized to study treatment and had at least 1 evaluable SBM post-dose measurement during the Double-blind Treatment Period. Last-observation-carried-forward (LOCF) was used to impute missing postbaseline values.||Number of SBMs/week||Standard Error|Mean
834232|NCT01275833|Primary|Range Finding of Functional and Hemodynamic Changes Using Echocardiographic Determined Measures.|Echocardiographic measures will include, but not be limited to, left ventricular volumes, left ventricular diameters, and ejection fraction.|6 months|The study was terminated early: long PR intervals are relatively rare in this population, and it would take an inordinately long time to enroll sufficient patients. Because of the early termination of the study, no data was analyzed since the primary objective is underpowered.|||||
834233|NCT01276054|Primary|Whether or Not a Patient Has Developed Grade 1+ LE|LE is defined using the CTCAE v3 definition: a >5-10% increase in the inter-limb volume in the ipsilateral arm compared to the unaffected arm.|During the first year post-operatively|Unable to analyze due to early termination of the study|||||
834234|NCT01276106|Primary|Change in HbA1c From Baseline|For efficacy analyses, the primary analysis was at Week 24 Endpoint, defined as the last valid post-baseline measurement taken at or before Week 24. Efficacy results for treatment groups were considered statistically significant if change from baseline relative to placebo had p<0.05.|24 weeks|The Full Analysis Set included all randomized patients who received at least 1 dose of study drug and had a baseline and at least 1 post-baseline HbA1c assessment.||percentage points||Standard Error|Least Squares Mean
834235|NCT01276171|Secondary|Total Success Rate||5 min|chi-squre test||Participants|||Count of Participants
834236|NCT01276171|Secondary|Time to Successful Cannulation||5 minutes|||min||Inter-Quartile Range|Median
834237|NCT01276171|Primary|First Attempt Success Rate With 3 Different Technique|The primary objective of this study is to compare the first attempt success rate for radial artery cannulation between the palpation, Doppler and U/S guided technique when applied by anesthesia trainees. Secondary outcomes include: success rate within 5 minutes, time to successful cannulation compared with three different techniques.|5 minutes|||participants|||Number
834238|NCT01276197|Primary|Diastolic BP Measurement at Follow-up|Participants BP measurement at 6-month follow-up|6-month following intervention|||mmHg||Standard Deviation|Mean
834239|NCT01276197|Primary|Systolic BP at Follow-up|Systolic Bp measurement at 6-month follow-up; we modeled the impact of Intervention assignment on SBP, adjusting for Baseline. Thus, baseline SBP was collected but not used as outcome; Baseline SBP us used as a covariate.|6 months after intervention|Our analyses was completed with those who completed follow-up visit and varies from participant flow as we are not able to include those lost to follow-up.||mmHg||Standard Deviation|Mean
834240|NCT01276223|Primary|Mean Change From Baseline (Week 0) in Visual Analog Scale (VAS) Global Ocular Discomfort Score Over 4 Weeks|A Visual Analog Scale (VAS) was used by the subject to assess ocular discomfort, both frequency and severity, at baseline (pre-treatment) and weekly thereafter for 4 additional weeks. Each scale was 100 millimeters (mm) in length. The VAS score was calculated by measuring the length in mm from the start of the line to the intersection point of the vertical mark made by the subject. The Global Ocular Discomfort Score is a composite of the two VAS scores, ranging from 0 (very mildly) to 100 (very severely uncomfortable).|Baseline, up to 4 weeks|All subjects randomized to treatment and receiving at least 1 administration of study medication (ITT). Mixed model repeated measure (MMRM) approach was used to handle missing data during randomized treatment period.||units on a scale||Standard Deviation|Mean
834370|NCT01267201|Secondary|Plasma Decay Half-life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hrs post-dose|PK parameter analysis population included all randomized participants who were treated and had at least 1 of the PK parameters of interest in at least 1 treatment period.||hr||Standard Deviation|Mean
834241|NCT01276288|Secondary|Number of Subjects With Clinical Relevant Abnormalities in Vital Signs, Clinical Laboratory Tests, 12-lead Resting Electrocardiogram (ECG), Physical Examination and Assessment of Tolerability by the Investigator|"Number of subjects with clinical relevant abnormalities in vital signs (blood pressure, pulse rate), 12-lead resting electrocardiogram (ECG), clinical laboratory tests (haematology, clinical chemistry, urinalysis, and monitoring of fasting plasma glucose), physical examination and assessment of tolerability by the investigator.
New abnormal findings were reported as Adverse Events (AE). Only Alanine aminotransferase normal under system organ class investigations was determined as an existing AE."|From first drug administration until up to 14 days after the last drug administration, up to 35 days|Treated set||participants|||Number
834242|NCT01276288|Primary|Urinary Sodium Excretion Over 24-hour run-in Periods|Urinary sodium excretion over 24-hour run-in periods to assess the harmonisation of electrolytes after intake of a standardised diet|Day 3, 2 and 1 before the first drug administration|PD analysis set completers||mmol/day||Standard Error|Mean
834243|NCT01276288|Secondary|Maximum Measured Concentration of TOR in Plasma (Cmax, ss)|Maximum measured concentration of Empa in plasma (Cmax, ss) at steady state|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, and 24 post-dose on Day 4 with TOR alone and on Day 9 with EMPA plus TOR. The Pre-dose values were averaged over Days 1 to 3 with TOR alone and on Days 7 & 8 with EMPA plus TOR|PK set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
834244|NCT01276288|Secondary|Area Under the Concentration-time Curve of TOR in Plasma (AUCτ,ss)|Area under the concentration-time curve of TOR in plasma at steady state over a uniform dosing interval τ (AUCτ,ss).|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, and 24 post-dose on Day 4 with TOR alone and on Day 9 with EMPA plus TOR. The Pre-dose values were averaged over Days 1 to 3 with TOR alone and on Days 7 & 8 with EMPA plus TOR|PK set||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
834245|NCT01276288|Secondary|Maximum Measured Concentration of HCT in Plasma (Cmax, ss)|Maximum measured concentration of HCT in plasma (Cmax, ss) at steady state|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, and 24 post-dose on Day 4 with HCT alone and on Day 9 with EMPA plus HCT. The Pre-dose values were averaged over Days 1 to 3 with HCT alone and on Days 7 & 8 with EMPA plus HCT|PK set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
834246|NCT01276288|Secondary|Area Under the Concentration-time Curve of HCT in Plasma (AUCτ,ss)|Area under the concentration-time curve of HCT in plasma at steady state over a uniform dosing interval τ (AUCτ,ss).|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, and 24 post-dose on Day 4 with HCT alone and on Day 9 with EMPA plus HCT. The Pre-dose values were averaged over Days 1 to 3 with HCT alone and on Days 7 & 8 with EMPA plus HCT|PK set||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
834247|NCT01276288|Secondary|Maximum Measured Concentration of Empa in Plasma (Cmax, ss)|Maximum measured concentration of Empa in plasma (Cmax, ss) at steady state|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, and 24 post-dose on Day 5 with EMPA alone and on Day 9 with EMPA plus diuretic. The Pre-dose values were averaged over Days 1 to 4 with EMPA alone and on Days 7 & 8 with EMPA plus diuretic|PK set||nmol/L||Geometric Coefficient of Variation|Geometric Mean
834248|NCT01276288|Secondary|Area Under the Concentration-time Curve of Empa in Plasma (AUCτ,ss)|Area under the concentration-time curve of Empa in plasma at steady state over a uniform dosing interval τ (AUCτ,ss).|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, and 24 post-dose on Day 5 with EMPA alone and on Day 9 with EMPA plus diuretic. The Pre-dose values were averaged over Days 1 to 4 with EMPA alone and on Days 7 & 8 with EMPA plus diuretic|Pharmacokinetic (PK) set, including all patients of the treated set who provide at least one observation for at least one secondary PK endpoint of AUC τ,ss or C max,ss for any analyte under any treatment without important protocol violations relevant to the evaluation of PK.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
834249|NCT01276288|Primary|The Change in Total Muscle Sympathetic Nerve Activity (MSNA) From Off- Treatment|The change in total Muscle sympathetic nerve activity (MSNA) that represents an area under the curve of all C-fiber action potentials per minute. This endpoint was evaluated only for Empa. For this endpoint a baseline value was not defined. However, the parameters obtained at 2 measurements time points during the trial were compared.|One day before the drug administration, then day 4 after the first drug administration|PD analysis set completers||action potentials per min||Standard Error|Mean
834250|NCT01276288|Primary|The Change in Micturition Frequency From the Baseline|For this endpoint the change in total micturition frequency from the baseline was only examined for EMPA where baseline was defined as the day before the first drug administration.|Baseline and day 5|PD analysis set completers||voids per day||Standard Error|Mean
834251|NCT01276288|Primary|Change in Urinary Weight From Baseline|"Change from baseline in urinary weight in a 24 hour (h)- collection period, where baseline is the last 24-h collection period before first trial drug administration in each treatment period.
The mean change from baseline was evaluated as:
Empa: day 5- baseline, HCT: day 4-baseline, TOR: day 4-baseline, Empa+ HCT: day 9- baseline, Empa+ TOR: day 9- baseline,
The mean for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa"|24 hour sampling interval at baseline and then day 5 for Empa, day 4 for TOR and HCT, day 9 for Empa+TOR and Empa+HCT|PD analysis set completers||g/day||Standard Error|Mean
834252|NCT01276288|Primary|Change in Body Weight From Baseline|"Change in body weight from baseline , where baseline was defined as the last measurement before trial drug administration of each treatment period
The mean change from baseline was evaluated as:
Empa: day 6- baseline, HCT: day 5-baseline, TOR: day 5-baseline, Empa+ HCT: day 10- baseline, Empa+ TOR: day 10- baseline,
The mean for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa"|baseline and then day 6 for Empa, day 5 for TOR and HCT, day 10 for Empa+TOR and Empa+HCT|PD analysis set completers||kg||Standard Error|Mean
834253|NCT01276288|Primary|Change in pH in Capillary or Arterialised Blood From Baseline|"Change in pH in capillary or arterialised blood from baseline, where baseline was defined as the last measurement before trial drug administration of each treatment period
The mean change from baseline was evaluated as:
Empa: day 6- baseline, HCT: day 5-baseline, TOR: day 5-baseline, Empa+ HCT: day 10- baseline, Empa+ TOR: day 10- baseline,
The mean for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa"|baseline and then day 6 for Empa, day 5 for TOR and HCT, day 10 for Empa+TOR and Empa+HCT|PD analysis set completers||pH||Standard Error|Mean
834254|NCT01276288|Primary|Changes in Bicarbonate Concentrations of Calcium, Bicarbonate Ions and Base Excess in Capillary or Arterialised Blood From Baseline|"Changes in bicarbonate concentrations of calcium, bicarbonate ions and base excess in capillary or arterialised blood from baseline, where baseline was defined as the last measurement before trial drug administration of each treatment period
The mean change from baseline was evaluated as:
Empa: day 6- baseline, HCT: day 5-baseline, TOR: day 5-baseline, Empa+ HCT: day 10- baseline, Empa+ TOR: day 10- baseline,
The means for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa"|baseline and then day 6 for Empa, day 5 for TOR and HCT, day 10 for Empa+TOR and Empa+HCT|PD analysis set completers||mmol/ L||Standard Error|Mean
834255|NCT01276288|Primary|Change in Urine Osmolality From Baseline|"Change in urine osmolality from baseline, where baseline was defined as the measurement obtained before first drug administration in the first period
The mean change from baseline was evaluated as:
Empa: day 6- baseline, HCT: day 5-baseline, TOR: day 5-baseline, Empa+ HCT: day 10- baseline, Empa+ TOR: day 10- baseline,
The mean for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa"|baseline and then day 6 for Empa, day 5 for TOR and HCT, day 10 for Empa+TOR and Empa+HCT|PD analysis set completers||mOsm/kg||Standard Error|Mean
834256|NCT01276288|Primary|Change in Urine pH From Baseline|"Change in urine pH from baseline, where baseline was defined as the measurement obtained before first drug administration in the first period
The mean change from baseline was evaluated as:
Empa: day 6- baseline, HCT: day 5-baseline, TOR: day 5-baseline, Empa+ HCT: day 10- baseline, Empa+ TOR: day 10- baseline,
The mean for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa"|baseline and then day 6 for Empa, day 5 for TOR and HCT, day 10 for Empa+TOR and Empa+HCT|PD analysis set completers||pH||Standard Error|Mean
834257|NCT01276288|Primary|Change in Urea Concentration in Urine|"Change in urea concentration in urine from baseline, where baseline was defined as the measurement obtained before first drug administration in the first period
The mean change from baseline was evaluated as:
Empa: day 6- baseline, HCT: day 5-baseline, TOR: day 5-baseline, Empa+ HCT: day 10- baseline, Empa+ TOR: day 10- baseline,
The mean for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa"|baseline and then day 6 for Empa, day 5 for TOR and HCT, day 10 for Empa+TOR and Empa+HCT|PD analysis set completers||mmol/L||Standard Error|Mean
834258|NCT01276288|Primary|Change in Serum Concentration of Fibroblast Growth Factor-23 (FGF- 23) From Baseline|"Change in serum concentration of fibroblast growth factor-23 (FGF- 23) from baseline, where baseline was defined as the measurement obtained before first drug administration in the first period
The mean change from baseline was evaluated as:
Empa: day 6- baseline, HCT: day 5-baseline, TOR: day 5-baseline, Empa+ HCT: day 10- baseline, Empa+ TOR: day 10- baseline, The mean for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa"|baseline and then day 6 for Empa, day 5 for TOR and HCT, day 10 for Empa+TOR and Empa+HCT|PD analysis set completers||RU/mL||Standard Error|Mean
834259|NCT01276288|Primary|Change in Serum Concentration of Aldosterone From Baseline|"Change in serum concentration of Aldosterone from baseline , where baseline was defined as the measurement obtained before first drug administration in the first period
The mean change from baseline was evaluated as:
Empa: day 6- baseline, HCT: day 5-baseline, TOR: day 5-baseline, Empa+ HCT: day 10- baseline, Empa+ TOR: day 10- baseline,
The mean for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa"|baseline and then day 6 for Empa, day 5 for TOR and HCT, day 10 for Empa+TOR and Empa+HCT|PD analysis set completers||nmol/L||Standard Error|Mean
834260|NCT01276288|Primary|Change in Serum Concentration of Renin, Intact Parathyroid Hormone (iPTH) and 1,25-dihydroxyvitamin D From Baseline|"Change in serum concentration of Renin, intact parathyroid hormone (iPTH) and 1,25-dihydroxyvitamin D from baseline , where baseline was defined as the measurement obtained before first drug administration in the first period
The mean change from baseline was evaluated as:
Empa: day 6- baseline, HCT: day 5-baseline, TOR: day 5-baseline, Empa+ HCT: day 10- baseline, Empa+ TOR: day 10- baseline,
The means for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa"|baseline and then day 6 for Empa, day 5 for TOR and HCT, day 10 for Empa+TOR and Empa+HCT|PD analysis set completers||pg/mL||Standard Error|Mean
834261|NCT01276288|Primary|Change in Serum Concentration of Alkaline Phosphatase (ALP) From Baseline|"Change in serum concentration of ALP from baseline, where baseline was defined as the measurement obtained before first drug administration in the first period
The mean change from baseline was evaluated as:
Empa: day 6- baseline, HCT: day 5-baseline, TOR: day 5-baseline, Empa+ HCT: day 10- baseline, Empa+ TOR: day 10- baseline,
The mean for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa"|baseline and then day 6 for Empa, day 5 for TOR and HCT, day 10 for Empa+TOR and Empa+HCT|PD analysis set completers||U/L||Standard Error|Mean
834262|NCT01276288|Primary|Change in Serum Concentration of Creatinine and Uric Acid From Baseline|"Change in serum concentration of Creatinine and Uric acid from baseline, where baseline was defined as the measurement obtained before first drug administration in the first period
The mean change from baseline was evaluated as:
Empa: day 5- baseline, HCT: day 4-baseline, TOR: day 4-baseline, Empa+ HCT: day 9- baseline, Empa+ TOR: day 9- baseline,
The means for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa"|baseline and then day 5 for Empa, day 4 for TOR and HCT, day 9 for Empa+TOR and Empa+HCT|PD analysis set completers||umol/L||Standard Error|Mean
834273|NCT01276301|Secondary|Mean Residence Time in the Body After Administration (MRTpo)|"Mean residence time of empagliflozin (empa) in the body after oral administration.
Note: The numbers provide below for standard deviation are of Coefficient of Variation."|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration|Pharmacokinetic (PK) set: All subjects who had taken at least one dose of trial medication, who had provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.||h||Geometric Coefficient of Variation|Geometric Mean
834263|NCT01276288|Primary|Change in Serum Concentration of Sodium, Potassium, Magnesium, Calcium, Chloride, Phosphate, Glucose and Urea From Baseline|"Change in serum concentration of sodium, potassium, magnesium, calcium, chloride, phosphate, glucose and urea from baseline, where baseline was defined as the measurement obtained before first drug administration in the first period
The mean change from baseline was evaluated as:
Empa: day 6- baseline, HCT: day 5-baseline, TOR: day 5-baseline, Empa+ HCT: day 10- baseline, Empa+ TOR: day 10- baseline,
The means for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa"|baseline and then day 6 for Empa, day 5 for TOR and HCT, day 10 for Empa+TOR and Empa+HCT|PD analysis set completers||mmol/L||Standard Error|Mean
834264|NCT01276288|Primary|Change in Serum Osmolality From Baseline|"Changes in serum osmolality from baseline based on a blood sample.
Baseline was defined as the measurement obtained before the first drug administration in the first period.
The mean change from baseline was evaluated as:
Empa: day 6- baseline, HCT: day 5-baseline, TOR: day 5-baseline, Empa+ HCT: day 10- baseline, Empa+ TOR: day 10- baseline,
The mean for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa"|baseline and then day 6 for Empa, day 5 for TOR and HCT, day 10 for Empa+TOR and Empa+HCT|PD analysis set completers||mOsm/Kg||Standard Error|Mean
834265|NCT01276288|Primary|Change in Urinary Excretion in a 24-hour Period of N-terminal Telopeptide (NTx) From Baseline|"Change in urinary excretion in a 24-hour period of N-terminal telopeptide (NTx) from baseline, where baseline was defined as the value obtained from the last 24-hour (h) collection period before the first drug administration in the first treatment period.
The mean change from baseline was evaluated as:
Empa: day 5- baseline, HCT: day 4-baseline, TOR: day 4-baseline, Empa+ HCT: day 9- baseline, Empa+ TOR: day 9- baseline,
The means for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa"|24 hour sampling interval at baseline and then day 5 for Empa, day 4 for TOR and HCT, day 9 for Empa+TOR and Empa+HCT|PD analysis set completers||nM BCE/ mMC||Standard Error|Mean
834266|NCT01276288|Primary|Change in Urinary Excretion in a 24-hour Period of Sodium, Potassium, Magnesium, Chloride, Calcium, Phosphate, Creatinine, Uric Acid, Glucose From Baseline|"Change in urinary excretion in a 24-hour period of sodium, potassium, magnesium, chloride, calcium, phosphate, creatinine, uric acid, glucose from baseline, where baseline was defined as the value obtained from the last 24-hour (h) collection period before the first drug administration in the first treatment period. This applies also to sodium excretion in urine, which is additionally obtained one day before the drug administration before the second period.
The mean change from baseline was evaluated as:
Empa: day 5- baseline, HCT: day 4-baseline, TOR: day 4-baseline, Empa+ HCT: day 9- baseline, Empa+ TOR: day 9- baseline,
The means for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa"|24 hour sampling interval at baseline and then day 5 for Empa, day 4 for TOR and HCT, day 9 for Empa+TOR and Empa+HCT|PD analysis set completers||mmol/day||Standard Error|Mean
834267|NCT01276288|Primary|Change in Clearance of Sodium, Potassium, Creatinine, Magnesium, Chloride,Calcium, Phosphate and Uric Acid From Baseline|"Change in clearance of sodium, potassium, creatinine, magnesium, chloride,calcium, phosphate and uric acid from baseline, where baseline is defined as the value obtained from the last 24-h collection period before the first drug administration in the first treatment period.
The mean change from baseline was evaluated as:
Empa: day 5- baseline, HCT: day 4-baseline, TOR: day 4-baseline, Empa+ HCT: day 9- baseline, Empa+ TOR: day 9- baseline,
The means for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa"|24 hour sampling interval at baseline and then day 5 for Empa, day 4 for TOR and HCT, day 9 for Empa+TOR and Empa+HCT|Pharmacodynamic (PD) analysis set completers includes all evaluable patients of the treated set who provide a baseline and at least one on-treatment observation for at least one primary (PD) endpoint under any treatment without important protocol violations relevant to the evaluation of PD and who continued the trial as planned||ml/min||Standard Error|Mean
834268|NCT01276301|Secondary|Assessment of Tolerability by Investigator|Tolerability will be assessed by the investigator according to the categories good, satisfactory, not satisfactory , bad and not assessable.|Within Day 15 to Day 25|Treated set||percentage of participants|||Number
834269|NCT01276301|Secondary|Clinically Relevant Abnormalities for Physical Examination, Vital Signs, Blood Chemistry and Electrocardiogram (ECG).|Clinically relevant abnormalities for physical examination, vital signs , blood chemistry and Electrocardiogram (ECG). New or abnormal findings were reported as adverse events.|Day1 to Day 11|Treated set (TS) included all subjects who had taken at least one dose of trial medication.||participants|||Number
834270|NCT01276301|Other Pre-specified|Verapamil Plasma Concentration|"Verapamil plasma concentration were measured in order to confirm exposure.
Note: No descriptive statistics was calculated for predose, 49.0 (h) and 73.0 (h), as most of the values were below the limit of quantification (BLQ)."|Predose and 1 hour (h), 25h, 49h and 73h after verapamil administration|Treated set (TS) included all subjects who had taken at least one dose of trial medication.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
834271|NCT01276301|Secondary|Apparent Volume of Distribution Following an Extravascular Dose (Vz/F)|"Apparent volume of distribution during the terminal phase following an extravascular dose.
Note: The numbers provide below for standard deviation are of Coefficient of Variation."|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration|Pharmacokinetic (PK) set: All subjects who had taken at least one dose of trial medication, who had provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation||L||Geometric Coefficient of Variation|Geometric Mean
834272|NCT01276301|Secondary|Apparent Clearance in Plasma After Extravascular Administration (CL/F)|"Apparent clearance of empagliflozin (empa) in plasma after extravascular administration.
Note: The numbers provide below for standard deviation are of Coefficient of Variation."|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration|Pharmacokinetic (PK) set: All subjects who had taken at least one dose of trial medication, who had provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.||mL/min||Geometric Coefficient of Variation|Geometric Mean
834274|NCT01276301|Secondary|Terminal Half-life in Plasma (t1/2)|"Terminal half-life of empagliflozin in plasma.
Note: The numbers provide below for standard deviation are of Coefficient of Variation."|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration|Pharmacokinetic (PK) set: All subjects who had taken at least one dose of trial medication, who had provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.||h||Geometric Coefficient of Variation|Geometric Mean
834275|NCT01276301|Secondary|Terminal Elimination Rate Constant (λz)|"Terminal elimination rate constant in plasma.
Note: The numbers provide below for standard deviation are of Coefficient of Variation."|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration|Pharmacokinetic (PK) set: All subjects who had taken at least one dose of trial medication, who had provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.||1/h||Geometric Coefficient of Variation|Geometric Mean
834276|NCT01276301|Secondary|Time From 0 to Maximum Plasma Concentration (Tmax)|Time from last dosing to the maximum plasma concentration|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration|Pharmacokinetic (PK) set: All subjects who had taken at least one dose of trial medication, who had provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.||h||Full Range|Median
834277|NCT01276301|Secondary|Area Under the Curve 0 to Time of Last Quantifiable Data Point (AUC0-tz)|Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 to time of last quantifiable data point.|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration|Pharmacokinetic (PK) set: All subjects who had taken at least one dose of trial medication, who had provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
834278|NCT01276301|Primary|Maximum Measured Concentration (Cmax)|Maximum measured concentration of empagliflozin (empa) in plasma.|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration|Pharmacokinetic (PK) set: All subjects who had taken at least one dose of trial medication, who had provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.||nmol||Geometric Coefficient of Variation|Geometric Mean
834279|NCT01276301|Primary|Area Under the Curve 0 to Infinity (AUC0-∞)|Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 extrapolated to infinity.|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration|Pharmacokinetic (PK) set: All subjects who had taken at least one dose of trial medication, who had provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
834280|NCT01276327|Secondary|Tmax for Pioglitazone|Time from dosing to the maximum measured concentration of the analyte in plasma for pioglitazone|0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)|PKS - The PKS included all evaluable subjects in the treated set who had no important PV relevant to the evaluation of bioequivalence and provided at least 1 evaluable observation for a pharmacokinetic endpoint in at least 1 treatment period.||hours||Full Range|Median
834281|NCT01276327|Secondary|Tmax for Linagliptin|Time from dosing to the maximum measured concentration of the analyte in plasma for Linagliptin|0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)|PKS - The PKS included all evaluable subjects in the treated set who had no important PV relevant to the evaluation of bioequivalence and provided at least 1 evaluable observation for a pharmacokinetic endpoint in at least 1 treatment period.||hours||Full Range|Median
834282|NCT01276327|Secondary|AUC0-∞ of Pioglitazone|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 hours extrapolated to inf for pioglitazone|0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)|PKS - The PKS included all evaluable subjects in the treated set who had no important PV relevant to the evaluation of bioequivalence and provided at least 1 evaluable observation for a pharmacokinetic endpoint in at least 1 treatment period.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
834283|NCT01276327|Secondary|AUC0-∞ of Linagliptin|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 hours extrapolated to infinity (inf) for linagliptin|0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)|PKS - The PKS included all evaluable subjects in the treated set who had no important PV relevant to the evaluation of bioequivalence and provided at least 1 evaluable observation for a pharmacokinetic endpoint in at least 1 treatment period.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
834284|NCT01276327|Secondary|AUC0-tz for Linagliptin|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point for Linagliptin|0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)|PKS - The PKS included all evaluable subjects in the treated set who had no important PV relevant to the evaluation of bioequivalence and provided at least 1 evaluable observation for a pharmacokinetic endpoint in at least 1 treatment period.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
834285|NCT01276327|Primary|Cmax of Pioglitazone|Maximum concentration of the analyte in plasma was measured. Adjusted by-treatment geometric mean and CV were calculated.|0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)|PKS - The PKS included all evaluable subjects in the treated set who had no important PV relevant to the evaluation of bioequivalence and provided at least 1 evaluable observation for a pharmacokinetic endpoint in at least 1 treatment period.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
834371|NCT01267201|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hrs post-dose|PK parameter analysis population included all randomized participants who were treated and had at least 1 of the PK parameters of interest in at least 1 treatment period.||hr||Full Range|Median
834286|NCT01276327|Primary|AUC0-tz of Pioglitazone|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point|0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)|PKS - The PKS included all evaluable subjects in the treated set who had no important PV relevant to the evaluation of bioequivalence and provided at least 1 evaluable observation for a pharmacokinetic endpoint in at least 1 treatment period.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
834287|NCT01276327|Primary|Cmax of Linagliptin|Maximum measured concentration of the analyte in plasma was measured. Adjusted by-treatment geometric mean and CV were reported.|0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)|PKS - The PKS included all evaluable subjects in the treated set who had no important PV relevant to the evaluation of bioequivalence and provided at least 1 evaluable observation for a pharmacokinetic endpoint in at least 1 treatment period.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
834288|NCT01276327|Primary|AUC0-72 of Linagliptin|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 72 hours|0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)|PKS - The PKS included all evaluable subjects in the treated set who had no important PV relevant to the evaluation of bioequivalence and provided at least 1 evaluable observation for a pharmacokinetic endpoint in at least 1 treatment period.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
834289|NCT01276353|Primary|Maximum Observed Plasma Concentration (Cmax) of E2020 on Visits 2 and 3||Visit 2 [Day1] and Visit 3 [Day 15]|Pharmacokinetic Analysis Set: the group of subjects who had received at least one quantifiable E2020 concentration in plasma||ng/mL||Standard Deviation|Mean
834290|NCT01276353|Secondary|Cmax of E2020 on Visits 2 and 3 According to Cytochrome P450 2D6 (CYP2D6) Phenotype Status|All subjects were identified as Extensive Metabolizer [EM] or Intermediate Metabolizer [IM] predicted from their CYP2D6 phenotypes. Ultra-rapid Metabolizer (UM) and Poor Metabolizer (PM) were not identified in any subject. Since the analysis population i|Visit 2 [Day1] and Visit 3 [Day 15]|Pharmacokinetic Analysis Set||ng/mL||Standard Deviation|Mean
834291|NCT01276457|Secondary|Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) or Deaths|Safety was assessed using reports of adverse events of all participants in this study. Serious adverse events are those events that resulted in death, were life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.|Baseline to end of study (Month 24)|Safety population: All randomized subjects who took at least one dose of study drug.||Partcipants|||Number
834292|NCT01276457|Secondary|Number of Participants Who Died, Number of Participants Who Lost Their Graft, and Number of Participants Who Died or Lost Their Graft|A participant lost his graft if he/she started dialysis and was not able to subsequently be removed from dialysis or underwent graft nephrectomy.|Baseline to end of study (Month 24)|Safety population: All randomized subjects who took at least one dose of study drug.||Participants|||Number
834293|NCT01276457|Primary|Renal Function Assessed by Creatinine Clearance|Renal function was assessed by measuring serum creatinine and by computing creatinine clearance using the formula of Cockcroft-Gault.|Month 12, Month 18, and Month 24|Intent-to-treat (ITT) population: All randomized subjects for whom at least one valid post-baseline efficacy measurement was obtained and used for efficacy analyses.||mL/min||Standard Deviation|Mean
834294|NCT01276457|Primary|Number of Participants With Biopsy-proven Acute Rejection|A graft core biopsy was performed on all suspected acute rejection episodes within 48 hours. Biopsies were read by the local pathologist according to the 1997 Banff criteria. A biopsy-proven acute rejection was be defined as a biopsy graded IA, IB, IIA, IIB, or III.|Baseline to end of study (Month 24)|Intent-to-treat (ITT) population: All randomized subjects for whom at least one valid post-baseline efficacy measurement was obtained and used for efficacy analyses.||Participants|||Number
834372|NCT01267201|Primary|Maximum Observed Plasma Concentration (Cmax)||0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hrs post-dose|PK parameter analysis population included all randomized participants who were treated and had at least 1 of the PK parameters of interest in at least 1 treatment period.||ng/mL||Standard Deviation|Geometric Mean
834308|NCT01276535|Secondary|Change From Baseline in Non-Inflammatory Lesion Count at 6 Weeks|The number of open comedones and closed comedones are summed to attain the total non-inflammatory lesion count.|Baseline and 6 weeks|||lesions||Standard Deviation|Mean
834309|NCT01276535|Secondary|Change From Baseline in Inflammatory Lesion Count at 6 Weeks|The number of pustules, papules and nodules are summed to attain a total inflammatory lesion count.|Baseline and 6 weeks|||lesions||Standard Deviation|Mean
834310|NCT01276535|Primary|Grade on the Burton et al. Acne Severity Grade Scale|The Burton et al. Acne Severity Grade Scale grades the type of acne lesion from Grade 0: no acne lesions through Grade 1: sub-clinical acne, Grade 2: mild acne, Grade 3: moderate acne; Grade 4: severe acne, to Grade 5: extremely severe acne. The number of participants whose entire face demonstrated an improvement of one or more grades on the Burton et al. Acne Severity Scale at week 6 relative to baseline was calculated.|baseline and 6 weeks|||participants|||Number
834839|NCT01280552|Primary|Overall Survival in HLA-A2 Patients|Overall survival in a predefined subpopulation. All randomized patients are included in intent to treat analysis.|2-3 years|Patients with HLA-A2 haplotype||months of survival||95% Confidence Interval|Median
834914|NCT01281306|Secondary|Number of Participants With Adverse Events, Serious Adverse Events and Death|Adverse event monitoring was conducted throughout the study.|8 weeks|Safety Analysis Set: The safety analysis set included all randomized participants who received at least one dose of study medication.||Number of participants|||Number
834972|NCT01281917|Secondary|Complete Response Rate|The complete response rate (CR) to therapy as defined by International Lymphoma Response Criteria.|Up to 60 months|||Participants|||Count of Participants
834364|NCT01261624|Secondary|ACR Pediatric Response Level (ACR 50, 70, 90 and 100) at Week 12|ACR Pediatric variables include: Physician's Global Assessment of disease activity on a 0- 100 mm visual analogue scale from 0 mm = no disease activity to 100 mm = very severe disease activity; Parent's or patient's Global Assessment of Patient's overall well-being on a 100 mm VAS from 0 mm = very well to 100 mm = very poor; Functional ability: Childhood Health Assessment Questionnaire; Number of joints with active arthritis using the ACR definition (any joint with swelling, or in the absence of swelling, limitation of motion accompanied by pain/tenderness not due to bone deformity); Number of joints with limitation of motion; Laboratory measure of inflammation: C-reactive protein (mg/L) Patients were considered as responders if they achieve at least an ACR Pediatric Criteria level 50, 70, 90 and 100 of response, defined as a 50%, 70%, 90% and 100% improvement as compared to baseline in at least 3 of the 6 variables listed above, with no more than 1 variable worsening by > than 30%|at week12|||participants|||Number
834365|NCT01261624|Primary|ACR Pediatric Response Level (ACRPRL) 30 After 12 Weeks of Treatment|ACR Pediatric variables include: Physician’s Global Assessment of disease activity on a 0-100 mm visual analogue scale from 0 mm = no disease activity to 100 mm = very severe disease activity; Parent’s or patient’s Global Assessment of Patient’s overall well-being on a 100 mm VAS from 0 mm = very well to 100 mm = very poor; Functional ability: Childhood Health Assessment Questionnaire; Number of joints with active arthritis using the ACR definition (any joint with swelling, or in the absence of swelling, limitation of motion accompanied by pain/tenderness not due to bone deformity); Number of joints with limitation of motion; Laboratory measure of inflammation: C-reactive protein (mg/L) Patients were considered as responders if they achieve at least an ACR Pediatric Criteria level 30 of response, defined as a 30% improvement as compared to baseline in at least 3 of the 6 variables listed above, with no more than 1 variable worsening by > than 30%|12 weeks of treatment|||participants|||Number
834366|NCT01267136|Secondary|Number of Participants Reporting Side Effects During the Post-tonsillectomy Recovery Period.|Parent-reported side effects entered in 10-day diary.|Side effects will be observed and recorded daily by caregivers for a total of 10 days in the take-home diary.|||participants|||Number
834367|NCT01267136|Primary|Efficacy of Two Different Liquid Pain Medications: Tramadol vs. Codeine/Acetaminophen During the Post-tonsillectomy Recovery Period.|Average number of post-operative days with pain score >4/10. Pain score assessments were administered once daily by parents using either the Numeric Rating Scale (NRS-11) (with anchors 0=no pain and 10=highest pain imaginable) for children ages 8-15 (von Baeyer et al., 2009) or the Faces Pain Scale-Revised (FPS-R) (with anchors 0=no pain and 10=highest pain imaginable) for children ages 4-10 (Hicks et al., 2001).|Efficacy was assessed daily during the 10-day postoperative recovery period.|||days||Full Range|Median
834373|NCT01267201|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hours (hrs) post-dose|Pharmacokinetic (PK) parameter analysis population included all randomized participants who were treated and had at least 1 of the PK parameters of interest in at least 1 treatment period.||ng*hr/mL||Standard Deviation|Geometric Mean
834374|NCT01267227|Secondary|Subjective Adverse Effects|Number of participants with adverse effects as a measure of safety|Baseline and 6-8 weeks|||participants|||Number
834375|NCT01267227|Secondary|Blood Pressure|Change in baseline systolic blood pressure and/or diastolic blood pressure|6-8 weeks||||||
834376|NCT01267227|Primary|Triglycerides|Change in baseline triglycerides (TG)|Baseline and 6-8 weeks|||mg/dL||Full Range|Mean
834377|NCT01267240|Secondary|Progression-free Survival|"PFS is defined as the duration of time from start of treatment to time of progression, death, or completion of the 1-year follow-up, whichever occurs first.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of the longest diameter of target lesions."|From time of treatment initiation to disease progression, death, or completion of the 1 year follow-up, whichever occurs first.|16 of 25 patients were evaluable for response.||months||95% Confidence Interval|Median
834378|NCT01267240|Secondary|Survival|Overall survival is defined as the length of time from start of treatment to death from any cause. Estimated using the Kaplan-Meier method.|Up to 1 year|16 patients of the 25 were eligible for response assessment.||months||95% Confidence Interval|Median
834379|NCT01267240|Primary|Response Rate According to Response Evaluation Criteria in Solid Tumors|Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT and MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters; Overall Response (OR) = CR + PR.|Up to 1 year|||participants|||Number
834380|NCT01267253|Other Pre-specified|Serum Expression Levels of Surrogate Markers of Brivanib Alaninate Effects Including Angiogenic Factors (VEGF and bFGF) and Markers of Endothelial Damage (E-selectin, VCAM-1, and ICAM-1)|Surrogate markers will be associated with response, PFS, and OS.|Up to 5 years||||||
834381|NCT01267253|Secondary|Overall Survival|Overall survival is defined as the duration of time from study entry to time of death or the date of last contact..|From study entry to time of death or the date of last contact, up to 5 years of follow-up.|Eligible and Treated Patients||Months||95% Confidence Interval|Median
834382|NCT01267253|Secondary|Progression-free Survival|Progression-free survival is the period of time from study entry to time of disease progression, death or date of last contact, whichever occurs first. Progression is assessed by RECIST 1.1|From study entry to time of progression or death, whichever occurs first, up to 5 years of follow-up|Eligible and Treated Participants||Months||95% Confidence Interval|Median
834383|NCT01267253|Primary|Adverse Events (Grade 3 or Higher) During Treatment Period|Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v.4.0|During treatment period and up to 30 days after stopping the study treatment.|Eligible and Treated Participants||Participants|||Number
834384|NCT01267253|Primary|PFS for at Least 6 Months Without Non-protocol Therapy From Study Entry.|Proportion of participants who survive progression-free for at least 6 months without non-protocol therapy from study entry. Progression is assessed by RECIST 1.1.|Every other cycle for first 6 months; then every 3 months therafter until disease progression confirmed; and at any other time if cliniclly indicated based on symptoms or physical signs suggestive of progressive disease|Eligible and treated participants||proportion||90% Confidence Interval|Number
834385|NCT01267253|Primary|Objective Tumor Response|Proportion of participants with objective tumor response. Objective tumor response is defined as complete or partial tumor response assessed by RECIST 1.1|Every other cycle for first 6 months; then every 3 months thereafter until disease progression confirmed; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.|Eligible and Treated participants||proportion||90% Confidence Interval|Number
834386|NCT01276652|Post-Hoc|Presence of Normal Spectral Edge Frequency 95% (SEF95) Activity|SEF95 is normally higher during wakefulness during sleep. The normal sleep SEF95 profile is rhythmic with an approximately 90 minute periodicity. We analyzed the number of subjects who exhibited this normal profile.|Average 4 days (patients followed to hospital discharge)|In one subject in the environmental modification group, the files were lost after acquisition and this analysis was unable to be performed.||Participants|||Count of Participants
834387|NCT01276652|Post-Hoc|Presence of Normal Slow Wave Activity|Slow wave activity in health exhibits diurnal and ultradian periodicity and a homeostatic decline at night. The number of subjects exhibiting these characteristics was calculated for each group.|Average 4 days (patients followed to hospital discharge)|In one subject in the environmental modification group, the files were lost after acquisition and this analysis was unable to be performed.||Participants|||Count of Participants
834388|NCT01276652|Other Pre-specified|Normal Timing of 6-sulfatoxymelatonin Excretion|The number of participants in each group who exhibit normal timing of 6-sulfatoxymelatonin excretion will be reported. The normal timing of peak melatonin excretion was considered to be between midnight and 05:00. Subjects in whom the melatonin onset occurred after midnight or the acrophase occurred after 05:00 were considered to be phase delayed, while patients whose acrophase occurred prior to midnight were considered to be phase advanced.|Average 4 days (patients followed to hospital discharge)|24-hour 6-sulfatoxymelatonin profiles were successfully collected in 16 subjects total. In one subject in the usual care (observational) group, there were insufficient data to determine melatonin timing.||Participants|||Count of Participants
834389|NCT01276652|Other Pre-specified|Occurrence of REM Sleep|Occurrence of identifiable rapid eye movement (REM) sleep in each subject.|Average 4 days (patients followed to hospital discharge)|In one subject in the environmental modification group, the files were lost after acquisition and this analysis was unable to be performed.||Participants|||Count of Participants
834473|NCT01278797|Primary|Area Under the Concentration-time Curve of Plasma Amlodipine From 0 to 72 Hours (AUC72)|Area under the analyte concentration versus time curve from time zero to 72 hours as calculated by the linear trapezoidal method|Day 1, Day 22|Analysis Set includes all randomized participants who completed the trial||nanograms*hour/milliliter||Standard Deviation|Mean
834390|NCT01276652|Secondary|Subject Tolerance of the Environmental Modification Protocol|This outcome measure will examine, in a preliminary fashion, subject tolerance of the environmental modification protocol. Tolerance will be assessed through qualitative interviews performed by the PI with the subjects.|Average 4 days (patients followed to hospital discharge)|Only subjects who received the intervention were assessed.||Subjects who tolerated the protocol|||Number
834391|NCT01276652|Primary|Percentage of Subjects Who Successfully Undergo Continuous Bedside Polysomnography for at Least 24 Hours.|This study assesses the feasibility of studying sleep and circadian rhythmicity in acutely ill, mechanically ventilated patients through the application of continuous bedside polysomnography. Feasibility will be assessed by determining the percentage of enrolled subjects who undergo at least 24 hours of continuous bedside polysomnography.|Average 4 days (patients followed to hospital discharge)|||Participants|||Count of Participants
834392|NCT01276756|Secondary|Safety of Nitazoxanide (Number of Participants Experiencing Adverse Events)|The occurence of adverse events that could be linked temporally and reasonably to the administration of the tested drug.|throughout the period of treatment and up to 90 days after end of triple therapy|||participants|||Number
834393|NCT01276756|Secondary|End-of-treatment Response|An end-of-treatment response is defined as a negative HCV PCR at 48 weeks after the start of pegylated interferon and ribavirin|48 weeks +- 7 days after starting pegylated interferon and ribavirin|ITT. Any patient who received at least one dose of interferon was included in the analyses.||participants|||Number
834394|NCT01276756|Secondary|Early Virological Response|"A complete early virologic response is defined as a negative HCV PCR 90 days after the start of pegylated interferon.
A partial early virologic response is defined as a decrease of 2 or more log in HCV PCR at 90 days after the start of pegylated interferon"|90 ± 7 days from the start of pegylated interferon and ribavirin|ITT. Any patient who received at least one dose of interferon was included in the analyses.||participants|||Number
834395|NCT01276756|Secondary|Rapid Virological Response|A rapid virologic response is defined as a negative HCV PCR 4 weeks after treatment|28 - 33 days after start of Pegylated interferon and ribavirin|"Only 1 patient in standard of care arm and 3 patients in the triple therapy arm missed doing the PCR test at week 4. These patients were thus not included in this particular analysis."||participants|||Number
834396|NCT01276756|Primary|Sustained Virologic Response|sustained virological response is defined as a negative HCV PCR at 180 days after the end of treatment (End of treatment being at 48 weeks for Group A, 52 weeks for Group B). For any patient who stopped treatment prematurely (e.g. due to adverse events) SVR was defined as a negative HCV PCR (polymerase chain reaction) at 180 days after the last dose of all medications (interferon, ribavirin and nitazoxanide)|180 days (+- 7 days) after the end of treatment. (48 weeks for Group A, 52 weeks for Group B, or after the last dose of treatment for patients who stopped prematurely).|All was intention-to-treat (ITT) analysis. Any patient who received at least one dose of interferon was included in the analyses.The only 2 dropouts (lost to follow-up) were calculated as failures.||participants|||Number
834397|NCT01276821|Other Pre-specified|Average Duration of Crying (in Minutes) Among Babies Receiving Nebulisation Therapy.|The outcomes tries to compare the influence of duration of crying among babies receiving nebulization which interferes with drug delivery and henceforth might create a confounding bias while interpreting results.|2 hours|||Minutes||Standard Deviation|Mean
834398|NCT01276821|Secondary|Persistence of Cough at the End of 1 Week|Number of patients in each intervention group whose parents reported the persistence of initial cough at the end of 1 week in their children.|7 days|||participants|||Number
834399|NCT01276821|Secondary|Missed Days of Work of Caregivers|Number of patients in each intervention group whose parents reported at least 1 day of missed work due to the illness of child within the week following the initial hospital visit on 7 day follow-up call.|7 days|||participants|||Number
834400|NCT01276821|Secondary|Need for Unscheduled Medical Visits, if Any, for Same Symptoms to Any Healthcare Facility Within 1 Week||7 days|||participants|||Number
834401|NCT01276821|Secondary|Relapse Rate|To study the number of patients in either group who need another unscheduled medical visit within the initial 24 hours of ER/ OPD visit|24 hours|||Participants|||Number
834402|NCT01276821|Secondary|Patients Meeting Eligibility Criteria for ER/ OPD Discharge at the End of 2 Hours of Observation||At the end of 2 hours|||participants|||Number
834403|NCT01276821|Primary|Mean Change in Clinical Severity Score|"Mean changes in the Clinical Severity Score after 2 sessions of nebulisation as compared to baseline.
Clinical Severity Score devised by Wang et al, is an objective scoring system that measures the degree of respiratory distress in young children.
The scoring system assesses respiratory rate, wheezing, retraction, and general condition,scores ranging from 0 to 3, with higher scores indicating severe illness and vice versa.
The total scores range from 0 to 12, with increased severity receiving a higher score (Wang et al, 1992).
This scoring systems have previously been validated in a number of well designed randomized controlled trials(Anil 2010, Kuzik 2007, Sarrell 2002, and Mandelberg 2003). A 1 point improvement in the clinical severity score implies approximately 7% betterment of symptoms on the scale."|2 hours|||units on a scale||Standard Deviation|Mean
834404|NCT01276847|Secondary|Change From Baseline in Gene Expression Score for Interleukin 17 (IL-17) in Psoriatic Lesions of Participants Treated With Etanercept|Participants had skin biopsies performed at baseline and after treatment with etanercept for 1,2,4 and 16 weeks. The expression of IL-17 mRNA was quantitated by qPCR, with the data normalized by the delta-delta Ct method. The expression score, showing the percentage difference from baseline, was calculated as follows : [(baseline - post baseline)/baseline] x 100.|Baseline and Weeks 1, 2, 4, and 16|Pre-specified to be collected only in participants treated with Etanercept.||Gene expression score||90% Confidence Interval|Median
834414|NCT01277822|Primary|Change in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8|Diastolic blood pressure was assessed at baseline and after 8 weeks of treatment with the participant in a seated position using an auto sphygmomanometer. Three measurements were performed at 2-minute intervals and the average of the 3 values of was recorded.|Baseline and Week 8|Full Analysis Set defined as all participants who were randomized, took at least 1 dose of study drug, and had blood pressure measurements at baseline and at least 1 post-randomization blood pressure measurement.||mmHg||Standard Deviation|Mean
834415|NCT01277861|Secondary|Coughing|Data include patients who coughed irrespective of the degree of coughing.|Intraoperative period|Per protocol||Participants, number|||Number
834416|NCT01277861|Secondary|Apnea|Apnea defined as no breathing for at least 30 s.|Induction of Anesthesia|Per protocol||Participants, number|||Number
834405|NCT01276847|Secondary|Change From Baseline in Composite Gene Expression Score Based on Interleukin 23 (IL-23) Pathway Related Genes in Psoriatic Lesions of Participants Treated With Ustekinumab|Skin biopsies were collected from participants at baseline and after treatment with ustekinumab for 1,2,4 and 16 weeks. The mRNA expression of eight pre-defined IL-23 pathway related genes, namely beta 4 defensin (DEFB4), CXC motif chemokine 8 (CXCL8), Interleukins 17A, 17F, 20, 22, 23A (IL-17, IL-17F, IL-20, IL-22, IL-23A) and cyclic AMP dependent protein kinase (CAMP) was quantitated by qPCR, with the data normalized by the delta-delta Ct method. The expression score for each gene, showing the percentage difference from baseline, was calculated as follows : [(baseline - post baseline)/baseline] x 100. Composite gene expression scores were derived for each individual by summing the expression scores of the individual genes. Positive composite scores denote a reduction from baseline in gene expression.|Baseline and Weeks 1, 2, 4, and 16|Pre-specified to be collected only in participants treated with Ustekinumab. One participant treated with Ustekinumab with extreme outlying data, likely due to mislabeling of lesional and nonlesional tissues, was excluded from the analysis.||Gene expression score||90% Confidence Interval|Median
834406|NCT01276847|Primary|Change From Baseline in Composite Gene Expression Score Based on IL-12 Pathway Related Interferon Gamma (IFN-γ)-Modulated Genes in Psoriatic Lesions of Participants Treated With Ustekinumab|Skin biopsies were collected from participants at baseline and after treatment with ustekinumab for 1,2,4 and 16 weeks. The expression of messenger RNA (mRNA) from three pre-defined IL-12 pathway related genes, modulated by interferon gamma (IFN-γ), namely IFN-γ, inducible nitric oxide synthase(iNOS) and CXC motif chemokine 10(CXCL10) was quantitated by real-time polymerase chain reaction (qPCR), with the data normalized by the delta-delta Ct method. The expression score for each gene, showing the percentage difference from baseline, was calculated as follows : [(baseline - post baseline)/baseline] x 100. Composite gene expression scores were derived for each individual by summing the expression scores of the individual genes. Positive composite scores denote a decrease from baseline in gene expression.|Baseline and Weeks 1, 2, 4, and 16|Pre-specified to be collected only in participants treated with Ustekinumab. One participant treated with Ustekinumab with extreme outlying data, likely due to mislabeling of lesional and nonlesional tissues, was excluded from the analysis.||Gene expression score||90% Confidence Interval|Median
834407|NCT01277822|Secondary|Change From Baseline in Ankle Circumference at Week 8|Each ankle was marked with a semi-permanent marker at approximately 3 cm proximal to the midpoint of the medial malleolus to aid consistency in the performance of the measurements. Ankle circumference was measured in both ankles at baseline and Week 8 using a tension controlled tape to minimize error.|Baseline and Week 8|All participants who received at least 1 dose of study drug and had available data for ankle circumference.||mm||Standard Deviation|Mean
834408|NCT01277822|Secondary|Percentage of Participants Who Had Peripheral Edema During the Study|A pitting assessment of edema on both legs was performed at baseline and throughout the study. Participants were assessed in a seated position with both feet extended and the right ankle in a neutral dorsiflexion position. The index finger was pressed firmly over the bony prominence approximately 3cm proximal to the midpoint of the medial malleolus of the right ankle and will be held for three seconds. Presence of a residual indentation in the area after releasing pressure on the index finger was considered positive for pitting edema.|up to 8 weeks|Safety Set defined as all participants who received at least 1 dose of study drug.||Percentage of Participants|||Number
834409|NCT01277822|Secondary|Percentage of Participants Who Achieve Target Blood Pressure at Week 4|Participants were evaluated at Week 4 to ascertain if target blood pressure had been obtained. Criteria for meeting target BP were: sitting diastolic BP (sitDBP) <90mmHg or sitting systolic BP (sitSBP) <140mmHg) or sitDBP change more than 10mmHg from baseline or sitSBP change more than 20mmHg from baseline.|Week 4|Full Analysis Set defined as all participants who were randomized, took at least 1 dose of study drug, and had blood pressure measurements at baseline and at least 1 post-randomization blood pressure measurement.||Percentage of Participants|||Number
834410|NCT01277822|Secondary|Percentage of Participants Who Achieve Target Blood Pressure at Week 8|Participants were evaluated at Week 8 to ascertain if target blood pressure had been obtained. Criteria for meeting target BP were: sitting diastolic BP (sitDBP) <90mmHg or sitting systolic BP (sitSBP) <140mmHg) or sitDBP change more than 10mmHg from baseline or sitSBP change more than 20mmHg from baseline.|Week 8|Full Analysis Set defined as all participants who were randomized, took at least 1 dose of study drug, and had blood pressure measurements at baseline and at least 1 post-randomization blood pressure measurement.||Percentage of Participants|||Number
834411|NCT01277822|Secondary|Change in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 4|Systolic blood pressure was assessed at baseline and after 4 weeks of treatment with the participant in a seated position using an auto sphygmomanometer. Three measurements were performed at 2-minute intervals and the average of the 3 values of was recorded.|Baseline and Week 4|Full Analysis Set defined as all participants who were randomized, took at least 1 dose of study drug, and had blood pressure measurements at baseline and at least 1 post-randomization blood pressure measurement.||mmHg||Standard Deviation|Mean
834412|NCT01277822|Secondary|Change in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8|Systolic blood pressure was assessed at baseline and after 8 weeks of treatment with the participant in a seated position using an auto sphygmomanometer. Three measurements were performed at 2-minute intervals and the average of the 3 values of was recorded.|Baseline and Week 8|Full Analysis Set defined as all participants who were randomized, took at least 1 dose of study drug, and had blood pressure measurements at baseline and at least 1 post-randomization blood pressure measurement.||mmHg||Standard Deviation|Mean
834413|NCT01277822|Secondary|Change in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 4|Diastolic blood pressure was assessed at baseline and after 4 weeks of treatment with the participant in a seated position using an auto sphygmomanometer. Three measurements were performed at 2-minute intervals and the average of the 3 values of was recorded.|Baseline and Week 4|Full Analysis Set defined as all participants who were randomized, took at least 1 dose of study drug, and had blood pressure measurements at baseline and at least 1 post-randomization blood pressure measurement.||mmHg||Standard Deviation|Mean
834417|NCT01277861|Primary|Movement|The data provided below include participants who moved (includes all grades of movement ie, mild, moderate and severe).|Induction of Anesthesia|Per protocol||Participants, number|||Number
834973|NCT01281917|Secondary|Safety of This Regimen|Safety of the regimen will be measured by frequency and severity of adverse events.|Up to 36 months|||Participants|||Count of Participants
834419|NCT01278160|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes|Treatment emergent hypoglycaemic episodes (hypos): those that happened between treatment and one day after last drug day. Hypos summarised based on American Diabetes Association classification. Severe hypos: episodes requiring another person to actively administer resuscitative actions. Minor hypos: episodes with symptoms with plasma glucose below 3.1 mmol/L (56 mg/dL) handled by the subject, or any asymptomatic plasma glucose below 3.1 mmol/L (56 mg/dL). Diurnal period: between 06:00 and 23:59 (both included). Nocturnal period: between 00:00 and 05:59 a.m. (both included).|Weeks 0-16|Full analysis set using LOCF (last observation carried forward) consists of all randomised subjects who were exposed to at least one dose of the trial product(s).||episodes|||Number
834420|NCT01278160|Secondary|Percentage of Subjects Achieving HbA1c Below or Equal to 6.5%|The percentage of subjects achieving the treatment target for glycosylated haemoglobin A1c (HbA1c) after 16 weeks of treatment|Week 16|Full analysis set using LOCF (last observation carried forward) consists of all randomised subjects who were exposed to at least one dose of the trial product(s).||percentage of subjects|||Number
834421|NCT01278160|Secondary|Percentage of Subjects Achieving HbA1c Below 7.0%|The percentage of subjects achieving the treatment target for glycosylated haemoglobin A1c (HbA1c) after 16 weeks of treatment|Week 16|Full analysis set using LOCF (last observation carried forward) consists of all randomised subjects who were exposed to at least one dose of the trial product(s).||percentage of subjects|||Number
834422|NCT01278160|Secondary|9-point SMPG (Self Measured Plasma Glucose) Profile|A 9-point SMPG profile included measurements before and 120 minutes after start of breakfast, lunch and main evening meal, measurements prior to bedtime and at 2:00 -4:00 a.m., and one before breakfast the following day|Week 16|Full analysis set using LOCF (last observation carried forward) consists of all randomised subjects who were exposed to at least one dose of the trial product(s).||mmol/L||Standard Error|Least Squares Mean
834423|NCT01278160|Primary|Change in Glycosylated Haemoglobin A1c (HbA1c) From Baseline||Week 0, week 16|Full analysis set using LOCF (last observation carried forward) consists of all randomised subjects who were exposed to at least one dose of the trial product(s). Six patients discontinued trial without any post randomisation HbA1c measurements.||percentage of glycosylated haemoglobin||Standard Deviation|Least Squares Mean
834424|NCT01278173|Primary|Change From Reference Value in Average RNFL (Retinal Nerve Fiber Layer) Thickness (µm) as Measured by SD-OCT (Spectral Domain-Optical Coherence Tomography)|Mean change from the reference value in average RNFL thickness (µm) as measured by SD-OCT. The reference value was defined as the average of the assessments performed at Visits 1 (baseline), 2 and 3 (first month of dosing). Thinning of the RNFL, that is, a negative change from the reference value, has been associated with ophthalmological disease.|Baseline (Month 0), Month 3, Month 6, Month 9, Month 12|All patients who had received at least one dose of IMP and who had a valid reference value assessment and at least one valid post-reference value assessment. The total number of patients included in the analysis set was 55. The actual number of patients analysed for each time point and eye is presented below (N = x).||µm||Standard Deviation|Mean
834425|NCT01278173|Primary|Mean Change From Reference Value in Field Width as Measured by 30-2 SITA Fast in Field Sensitivity (Mean Deviation - MD in dB)|Mean change from the reference value in 30-2 SITA mean deviation, which was generated using the University of Iowa Visual Field Reading Center (VFRC) normative database and the Humphrey Field Analyzer (HFA) normative database. The reference value was defined as the average of the assessments performed at Visits 1 (baseline), 2 and 3 (first month of dosing). The mean change from the reference value are presented for Months 3, 6, 9 and 12. A negative change from the reference value indicates a decrease in the central visual field.|Baseline (Month 0), Month 3, Month 6, Month 9, Month 12|All patients who had received at least one dose of investigational medicinal product and who had a valid reference value assessment and at least one valid post-reference value assessment. The total number of patients included in the analysis set was 55. The actual number of patients analysed for each time point and eye is presented below (N = x).||dB||Standard Deviation|Mean
834426|NCT01278303|Secondary|Secondary Safety Outcomes - Adverse Events|"Secondary Safety Outcomes
The proportion of patients experiencing any serious or somewhat serious adverse event related to the stent or implant procedure by 24 months follow up, such as: new aortic wall injury within the region of covered CP Stent implantation, stent malposition, stent fracture, aortic wall aneurysms (early or late), or restenosis requiring reintervention, arterial access site injury, bleeding, etc."|2 years|||percentage of participants|||Number
834427|NCT01278303|Secondary|Secondary Efficacy Outcomes - 1 Year|"Secondary Efficacy Outcomes
At One Year: (A) Number of participants with arm-leg systolic blood pressure (SBP) differences <15 mmHg and (B) Number of participants with normal or only mildly elevated SBP, no more than mild arm-leg SBP, no clinically significant residual aortic wall injury AND no worsening in any of these three categories"|1 years|||participants|||Number
834428|NCT01278303|Primary|Study Participants With Grade 4 or 5 in Degree of Aortic Wall Injury (AWI) and/or Aortic Arch Obstruction Without Clinical Worsening|"Severity of Illness Scale (SIS) improvement increase of at least 1 grade from baseline to 12 month follow-up
SIS is divided into 3 conditions & 5 grades of severity: 1 = worst (reserved for AWI) , 5 = best) C1 Upper Extremity Systolic Blood Pressure (SBP) 2- > 159 mmHg or any hpn on >2 medications 3- 140-159 mmHg or elevated SBP on >2 medications 4- 130-139 mmHg or normal SBP on >2 medications 5- <130 mmHg on 0-2 meds
C2 Upper Extremity to Lower Extremity SBP difference 2- >59 mmHg 3- 30-59 mmHg 4- 15-29 mmHg 5- <15 mmHg
C3
Aortic Wall Injury severity levels:
Uncontained rupture or large aneurysm
Contained rupture or stable large aneurysm
Small contained rupture or moderate aneurysm
Acute, but stable AWI or small aneurysm
No injury or minor aortic wall irregularity not in need of treatment.
Grades for conditions represent comparable degrees of illness (0 worst, 5 best) -Grade 0 denotes death related to coarctation or study therapy"|Baseline and 12 months|Participants available for analysis at one year||participants|||Number
834429|NCT01278342|Secondary|The Percentage of Participants With Partial Response (PR) at 8 Months|"Patients who met one of the following criteria at the end of 8 months of treatment were defined as Partial Responders, regardless of the treatment.
Mean 1 hour GH > 2.5 µg/L and < 5 µg/L and either a decrease in IGF-I of at least 50% compared to baseline or IGF-I within normal range.
Mean 1 hour GH < 2.5 µg/L and a decrease in IGF-I of at least 50% compared to baseline and IGF-I outside normal range."|From Baseline to 8 months|Intent-to-Treat population - all participants receiving at least one dose of Sandostatin LAR||percent||95% Confidence Interval|Number
834430|NCT01278342|Secondary|The Percentage of Participants With Complete Response (CR) At 3 Months|"A patient was classified as CR if both biochemical parameters were controlled at the end of 3 months of treatment:
Mean 1 hour GH < 2.5µg/L (according to Central Laboratory); and
IGF-I within the Central Laboratory Normal Range (for age and gender)"|From Baseline to 3 months|Intent-to-Treat population - all participants receiving at least one dose of Sandostatin LAR||percent||95% Confidence Interval|Number
834431|NCT01278342|Primary|The Percentage of Participants With Complete Response (CR) at 8 Months|"A patient was classified as a Complete Responder (CR) if both biochemical parameters were controlled at the end of 8 months of treatment:
Mean 1 hour GH < 2.5µg/L (according to Central Laboratory); and
IGF-I within the Central Laboratory Normal Range (for age and gender)."|From Baseline to 8 months|Intent-to-Treat population - all participants receiving at least one dose of Sandostatin LAR||percent||95% Confidence Interval|Number
834439|NCT01278407|Primary|Change From Baseline in Neuropsychiatric Inventory (NPI-2) Score|The NPI was a questionnaire that quantified psychiatric symptoms and behavioral disorders in dementia. A total of 12 items (the original NPI-10 consisting of 10 behavioral domains: delusions, hallucinations, agitation/aggression, dysphoria, anxiety, euphoria, apathy, disinhibition, irritability/lability, and aberrant motor behavior, supplemented by 2 dementia with Lewy bodies (DLB)-relevant domains of sleep, and cognitive fluctuation [reported as cognitive fluctuation inventory]) were assessed. The score of each item was calculated as frequency (scale: 1=occasionally to 4=very frequently) x Severity (scale: 1=Mild to 3=Severe). The NPI-2 was calculated as the sum of the scores for hallucinations and cognitive fluctuation, to yield a possible total score of 0 to 24. Lower score=less severity. A negative change score from baseline indicated improvement. Data are presented as change from baseline in mean NPI-2 +/- standard deviation.|Week 12 for Confirmatory Phase|Full Analysis Set: Efficacy was analyzed in the full analysis set, including the randomized participants who received the study drug at least once and had valid efficacy assessment data at more than one point.||Units on a scale||Standard Deviation|Mean
834440|NCT01278407|Primary|Change From Baseline in Mini-Mental State Examination (MMSE) Score|The MMSE was used to measure cognitive impairment. The MMSE can evaluate overall cognitive function, and is widely used for the assessment of cognitive impairment in dementia patients. The questionnaire consists of 11 items, and each item aims to evaluate different cognitive domains such as orientation, memory, attention, and construction. The score ranged from 0 to 30, with a higher score indicating better function. A positive change score indicated improvement from baseline. Data are presented as change from baseline in mean MMSE +/- standard deviation.|Week 12 for Confirmatory Phase|Full Analysis Set: Efficacy was analyzed in the full analysis set, including the randomized participants who received the study drug at least once and had valid efficacy assessment data at more than one point.||Units on a scale||Standard Deviation|Mean
834441|NCT01278485|Secondary|Number of Participants Reporting Body Weight Fears in the 12 Months Prior to Enrollment|On the day of enrollment, participants were asked to rate their fear of gaining weight in the 12 months prior to enrollment using a self-administered questionnaire. The questionnaire elicited responses to 3 statements (I worry about gaining weight; I worry that my diabetic treatment makes me gain weight; and I worry about not being able to stabilize my weight) and relied on a scale of 0 to 4, where 0=never, 1=rarely, 2=sometimes, 3=often, and 4=almost always.|Up to 12 Months Prior to Enrollment|All enrolled participants that completed the fear of weight gain questionnaire.||Score on a Scale||Standard Deviation|Mean
834442|NCT01278485|Secondary|Number of Participants Experiencing a Change in Body Weight in the 12 Months Prior to Enrollment|Participants were asked to rate their weight change experience in the 12 months prior to enrollment as: weight increased, weight decreased, or weight remained stable.|Up to 12 Months Prior to Enrollment|All enrolled participants||Participants|||Number
834474|NCT01278927|Secondary|Survival|Both survival at 6 months and overall survival at last follow-up will be reported. Overall survival is defined as the interval between transplantation and death or last follow-up. Patients alive when the study closes or lost to follow up are censored at the date of last contact.|6 months and 1 year|||percentage of participants||95% Confidence Interval|Number
834443|NCT01278485|Secondary|Participant Mean Score on the Worry Scale of Hypoglycemia Fear Survey (HFS II) At the Time of Enrollment|Fear about hypoglycemia during 6 months prior to enrollment was evaluated using the Worry Scale of the HFS II. Responses to the 18-item questionnaire were recorded on a 0 to 4 scale, with 0=never, 1=rarely, 2=sometimes, 3=often, 4=almost always. The total score ranges from 0 to 72, with higher scores indicating increasing fear of hypoglycemia.|Day of Enrollment|All enrolled participants that completed the worry scale of the HFS II.||Score on a Scale||Standard Deviation|Mean
834444|NCT01278485|Primary|Number of Participants With Hemoglobin A1c <7.0% at the Time of Enrollment|Participant serum samples were collected after an overnight fast to determine the hemoglobin A1c level. Hemoglobin A1c is a measure of the percentage of glycated hemoglobin in the blood and provides an indication of participant blood glucose control in the 2 to 3 months prior to the evaluation.|Day of Enrollment|All enrolled participants with a hemoglobin A1c measurement collected on the day of enrollment.||Participants|||Number
834445|NCT01278485|Secondary|Participant Mean Score on the Self-Reported Adherence and Barriers Questionnaire At the Time of Enrollment|The self-reported adherence and barriers questionnaire to measure treatment compliance asked participants to rate their responses to 5 questions: How often do you take your diabetes medicines exactly as your healthcare provider prescribes them?; During the past 4 weeks, how often were you unsure about some of the things your doctor suggested you do for your diabetes?; During the past 4 weeks, how often were you unable to do what was necessary to follow your doctor's treatment plans for your diabetes?; During the past 4 weeks, how often were you bothered by side effects from your medicines?; and During the past 4 weeks, how often did you have problems getting your prescriptions filled? Participants responded using a scale of 1 to 5, where 1=always, 2=usually, 3=sometimes, 4=rarely, and 5=never.|Day of Enrollment|All enrolled participants that completed a questionnaire on the day of enrollment.||Score on a Scale||Standard Deviation|Mean
834446|NCT01278485|Secondary|Participant Mean Score on the Treatment Satisfaction Questionnaire for Medication (TSQM) At the Time of Enrollment|The TSQM is a treatment satisfaction questionnaire containing 14 items covering the following dimensions: side effects, effectiveness, convenience, and global satisfaction. Participants were asked to respond in a yes or no fashion, or by using a 5- or 7-point Likert scale. The score for each dimension ranges from 0 to 100, with a higher score expressing a better quality of life.|Day of Enrollment|All enrolled participants that completed the TSQM on the day of enrollment.||Score on a Scale||Standard Deviation|Mean
834447|NCT01278485|Secondary|Participant Mean Score on the EuroQol Visual Analog Scale (EQ-VAS) Quality-of-Life Questionnaire At the Time of Enrollment|Participant health status was self-reported in 5 domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and was analyzed by using visual analog scale (VAS) which records participant responses on a scale of 0 (poor health) to 100 (excellent health).|Day of Enrollment|All enrolled participants with a completed EQ-VAS questionnaire.||Score on a Scale||Standard Deviation|Mean
834448|NCT01278485|Secondary|Participant Mean Score on the EuroQol-5 Dimension (EQ-5D) Quality-of-Life Questionnaire At the Time of Enrollment|The EQ-5D is a questionnaire that assesses participant quality of life in 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each domain has 3 levels: no problems, some problems, extreme problems for which participants are asked to self-rate their experience. The EQ-5D total score ranges from -0.171 (worst health state) to 1 (perfect health state) and 1 reflects the best outcome.|Day of Enrollment|All enrolled participants with a completed EQ-5D questionnaire.||Score on a Scale||Standard Deviation|Mean
834449|NCT01278485|Primary|Number of Participants Experiencing Mild, Moderate, Severe, or Very Severe Hypoglycemic Episodes in the 6 Months Prior to Enrollment|At the time of enrollment, participants were asked to rate their hypoglycemic episodes in the last 6 months as mild, moderate, severe, or very severe. Participants were able to select more than one category.|Up to 6 Months Prior to Enrollment|All enrolled participants that experienced hypoglycemia in the prior 6 months.||Participants|||Number
834450|NCT01278485|Primary|Number of Participants Experiencing Hypoglycemic Episodes in the 6 Months Prior to Enrollment|The participant experience of low blood sugar (hypoglycemia) questionnaire was used to evaluate participants' experience of hypoglycemia during the previous 6 months. Participants were asked to record whether they experienced hypoglycemia symptoms (yes/no) and to record the severity of those symptoms as mild, moderate, severe, or very severe.|Up to 6 Months Prior to Enrollment|All enrolled participants.||Participants|||Number
834451|NCT01278615|Primary|Disease Control Rate (Complete Response [CR], Partial Response [PR], and Stable Disease [SD]) in Patients Treated With Selumetinib|Estimates of the disease control rate with the exact two-sided 95% confidence intervals. Response was measured utilizing “Non-Hodgkins Lymphoma Response Criteria”. These criteria are based upon the criteria from the Revised Response Criteria for Malignant Lymphoma, (Cheson et al.), Journal of Clinical Oncology, 2007, Vol. 25:579-586. Using these criteria, ‘disease control rate’ encompassed patients who had either a CR, PR, and SD.|Up to 3 years|||percentage of disease control||95% Confidence Interval|Number
834452|NCT01278615|Secondary|Time to Treatment Failure|The Kaplan-Meier procedure will be used to characterize the survivorship function. Median time-to-event and the corresponding two-sided 95% confidence intervals will be provided.|Time from study entry to treatment failure, defined as lymphoma progression or withdrawal from treatment due to adverse events, assessed up to 3 years. Patients who die without progression while still on therapy will be censored as of the time of death.|||days||95% Confidence Interval|Mean
834453|NCT01278615|Secondary|Progression-free Survival|The Kaplan-Meier procedure will be used to characterize the survivorship function. Median time-to-event and the corresponding two-sided 95% confidence intervals will be provided.|Time from entry onto study until lymphoma progression or death from any cause, assessed up to 3 years|||days||95% Confidence Interval|Median
834454|NCT01278615|Secondary|Overall Survival|The Kaplan-Meier procedure will be used to characterize the survivorship function. Median time-to-death and the corresponding two-sided 95% confidence intervals will be provided.|Date of study entry to the date of death, assessed up to 3 years|||days||95% Confidence Interval|Median
834455|NCT01278615|Secondary|Incidence of Adverse Events Graded Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0|Percentage of patients experiencing any grade 3 or higher adverse event at least possibly attributed to the study drug. (Additional adverse event reporting will appear in the AE outcomes module.)|Up to 3 years|||percentage of participants||95% Confidence Interval|Number
834457|NCT01278615|Primary|Response Rate (Complete Response [CR] and Partial Response [PR]) in Patients Treated With Selumetinib|Estimates of the response rate based on best response (CR and PR) with the exact two-sided 95% confidence intervals. Response for this lymphoma clinical study was measured utilizing “Non-Hodgkins Lymphoma Response Criteria”. These criteria are based upon the criteria from the Revised Response Criteria for Malignant Lymphoma, (Cheson et al.), Journal of Clinical Oncology, 2007, Vol. 25:579-586.|Up to 3 years|||percentage of response||95% Confidence Interval|Number
834458|NCT01278745|Secondary|Post-transplant Safety Outcomes Among Participants: Safety and Tolerability of Rituximab|Defined as participants that experienced at least one adverse event that was possibly, probably, or definitely related to the study drug (i.e., Rituximab or Placebo). Serious adverse events were used to evaluate this endpoint and the attribution was based on the DAIT Medical Monitor's assessment.|Transplantation through end of study, up to 1 year post transplantation|Randomized participants||Participants|||Count of Participants
834459|NCT01278745|Secondary|Number of Participants With Post-transplant Incidence of PTLD|The number of participants experiencing at least one post-transplant lymphoproliferative disorder (PTLD) occurrence during this trial. Post-transplant lymphoproliferative disorder is an uncontrolled proliferation of B cell lymphocytes latently infected with Epstein-Barr virus.|Transplantation through end of study, up to 1 year post transplantation.|Randomized participants||Participants|||Count of Participants
834460|NCT01278745|Secondary|Number of Participants With Post-transplant Serious Infections Requiring Intravenous Antimicrobial Therapy|Number of participants experiencing at least one serious infection requiring intravenous antimicrobial therapy which is used to kill the growth of microorganisms such as bacteria, fungi, or protozoans.|Transplantation through end of study, up to 1 year post transplantation.|Randomized participants||Participants|||Count of Participants
834461|NCT01278745|Secondary|Number of Participants With Development of Angiographically Evident Cardiac Allograft Vasculopathy|Cardiac allograft vasculopathy is an aggressive form of atherosclerosis that is characterized by the development of fibrosis affecting cardiac arteries that result in concentric narrowing of the arteries and, ultimately allograft failure. Development of cardiac allograft vasculopathy can be diagnosed via an angiograph which is an X-ray of the cardiac arteries by injecting a radiopaque substance such as iodine.|1 year|Randomized participants||Participants|||Count of Participants
834462|NCT01278745|Secondary|Number of Participants With Episodes of Rejection Associated With Hemodynamic Compromise (HDC)|The number of participants that experienced at least one episode of rejection associated with hemodynamic compromise (HDC). Rejection associated with HDC is when there is insufficient blood flow to the transplanted heart in association with acute rejection found in a biopsy. Local biopsies were used for this outcome measure.|6 to 12 months|Randomized participants||Participants|||Count of Participants
834463|NCT01278745|Secondary|Incidence of Any Treated Rejection|The number of participants who were treated by their local physician for any type of rejection including, but not limited to cellular rejection and antibody- mediated rejection (AMR) of the transplanted heart regardless of the presence of a biopsy.|6 to 12 months|Randomized participants||Participants|||Count of Participants
834464|NCT01278745|Secondary|Incidence of Cellular Rejection|Cellular Rejection refers to the organ recipient's immune system recognizing a transplanted organ as foreign and mounting a response to it via cellular mechanisms. Cellular rejection was defined as a biopsy which met The International Society for Heart & Lung Transplantation (ISHLT) criteria to be graded as 1R or greater rejection and was determined by a single, central pathology laboratory|6 to 12 months|Randomized participants with at least one centrally read heart biopsy||Participants|||Count of Participants
834465|NCT01278745|Secondary|Incidence of AMR|The number of participants who experienced antibody- mediated rejection (AMR). Antibody-mediated rejection (AMR) occurs when the subject develops antibodies directed against the transplanted heart. This was assessed based on local pathology biopsy reads.|6 to 12 months|Randomized participants||Participants|||Count of Participants
834466|NCT01278745|Secondary|Incidence of BPAR (Any Grade)|The number of subjects who experienced any grade of biopsy proven acute rejection (BPAR) within the clinical trial. Biopsy proven acute rejection is when an examination of tissue removed from the transplanted organ indicates that the subject’s immune system is trying to reject the graft. BPAR was defined as a biopsy which met The International Society for Heart & Lung Transplantation (ISHLT) criteria to be graded as 1R or greater rejection and was determined by a single, central pathology laboratory.|6 to 12 months|Randomized participants with at least one centrally read heart biopsy||Participants|||Count of Participants
834467|NCT01278745|Secondary|Number of Episodes of Biopsy Proven Acute Rejection (BPAR) of Any Grade Per Participant|The number of times a participant experienced biopsy proven acute rejection (BPAR). Biopsy proven acute rejection is when an examination of tissue removed from the transplanted organ indicates that the subject’s immune system is trying to reject the graft. BPAR was defined as a biopsy that met the International Society for Heart & Lung Transplantation (ISHLT) criteria to be graded as 1R or greater rejection and was determined by a single, central pathology laboratory.|6 to 12 months|Randomized participants with at least one centrally read heart biopsy||Participants|||Count of Participants
834468|NCT01278745|Secondary|Re-transplantation or Re-listed for Transplantation|Re-transplantation is defined as the receipt of a subsequent heart transplant and re-listed for transplantation is being listed back on the heart transplant list to be re-transplanted.|6 to 12 months|Randomized participants||Participants|||Count of Participants
834469|NCT01278745|Secondary|Death|Participants who died within 12 months post-transplant|12 months|Randomized subjects||Participants|||Count of Participants
834470|NCT01278745|Primary|Change in Percent Atheroma Volume (PAV)|Nominal or noticeable change, bad or good, from baseline to 1 year in percent atheroma volume (PAV) which is a measure of the degree of coronary arterial obstruction due to host alloimmune processes measured by intravascular ultrasound (IVUS) in a target coronary artery. Thus a decrease in PAV would be an indicator of less obstruction and a better outcome.|Baseline, 1 year|Randomized participants with available data at year one||percent||Standard Deviation|Mean
834471|NCT01278797|Secondary|Time of Maximum Concentration of Amlodipine (TMAX)|Time of maximum measured amlodipine concentration over the zero to 72 hour sampling period|Day 1, Day 22|Analysis Set includes all randomized participants who completed the trial||hours||Standard Deviation|Mean
834472|NCT01278797|Primary|Maximum Observed Plasma Concentration (Cmax) of Amlodipine||Day 1, Day 22|Analysis Set includes all randomized participants who completed the trial||nanograms/milliliter||Standard Deviation|Mean
834478|NCT01278927|Secondary|The Pittsburgh Sleep Quality Index (PSQI)|The Pittsburgh Sleep Quality Index (PSQI) is a widely used seven item self-report measure of sleep patterns and difficulties. A modified version will be used to obtain self-reports of the following for the past week: sleep quality, sleep latency, sleep efficiency, and use of sleeping medications. The scale ranges from 0 - 21, where a higher score reflects worse sleep quality.|100 days|||units on a scale||Standard Deviation|Mean
834479|NCT01278927|Secondary|Cancer and Treatment Distress (CTXD)|Cancer and treatment distress will be measured by the acute version of the Cancer and Treatment Distress (CTXD) scale, a 27 item validated measure of distress with domains of Uncertainty, Health Burden, Family Strain, Identity and Managing the Medical System used extensively in HCT studies. The scale ranges from 0 - 3, where a higher score reflects more distress.|100 days|||units on a scale||Standard Deviation|Mean
834480|NCT01278927|Primary|Functional Status|To determine whether exercise or stress management improves self-reported physical and mental functioning compared to standard care at 100 days post hematopoietic cell transplantation (HCT) using evaluated patients. The Physical Component Score (PCS) and Mental Component Score (MCS) of the SF-36 will be the primary endpoint measures of functional status. Raw scores are converted to a standard metric (0-100), with higher scores being indicative of a better health state.|100 days|||units on a scale||Standard Deviation|Mean
834481|NCT01278927|Secondary|Symptoms|Patients will complete the MOS 36-Item Short Form (SF-36), a widely used self-report measure designed to assess perceived health and functioning, contains eight scales: Physical Functioning (PF), Role-Physical (R-P); Bodily Pain (BP); General Health (GH); Vitality (VT); Social Functioning (SF); Mental Health (MH); and Role-Emotional (R-E). Scales are comprised of different numbers of items and use a variety of rating formats. Raw scores are converted to a standard metric (0-100), with higher scores being indicative of a better health state.|100 days|||units on a scale||Standard Deviation|Mean
834482|NCT01278953|Primary|Incidence of Device-related Early-onset Primary Serious Adverse Events|Includes serious adverse events occurring within 7 days of the index procedure or hospital discharge, whichever is later, and diagnosed at any time during the follow-up period.|12 months|||participants|||Number
834483|NCT01278953|Primary|Freedom From Recurrence of Symptomatic Atrial Fibrillation, Atrial Tachycardia or Atrial Flutter|Includes both acute success (successful electrical isolation of all pulmonary veins) and chronic success. Re-treatment for AF with ablation or the use of Class I or Class III antiarrhythmic drugs after a 3 month blanking period constitute a treatment failure.|12 months|||participants|||Number
834484|NCT01279044|Secondary|Number of Condom-protected Anal Intercourse Events|"The outcome measure data shows the rate of change in the mean value of the number of condom-protected anal intercourse (UAI) events. Behaviors were self-reported at each study visit using during the past 3 months as the recall period. Study visits took place at baseline, 3 month, and 6 month timepoints.
Serodiscordant defined as having partner of discordant or of unknown HIV serostatus."|Self-reported behavior during past 3 months|||Self reported behavior in past 3 months|||Number
834485|NCT01279044|Secondary|Number of Receptive UAI Events|"The outcome measure data shows the rate of change in the mean value of the number of receptive unprotected anal intercourse (UAI) events. Behaviors were self-reported at each study visit using during the past 3 months as the recall period. Study visits took place at baseline, 3 month, and 6 month timepoints."|Self-reported behavior during past 3 months|||Self reported behavior in past 3 months|||Number
834486|NCT01279044|Secondary|Number of Instertive UAI Events|"The outcome measure data shows the rate of change in the mean value of number of instertive unprotected anal intercourse (UAI) events. Behaviors were self-reported at each study visit using during the past 3 months as the recall period. Study visits took place at baseline, 3 month, and 6 month timepoints."|Self-reported behavior during past 3 months|||Self reported behavior in past 3 months|||Number
834487|NCT01279044|Secondary|Number of Serodiscordant Unprotected Anal Intercourse (SDUAI) Events|"The outcome measure data shows the rate of change in the mean value of number of serodiscordant unprotected anal intercourse events. Behaviors were self-reported at each study visit using during the past 3 months as the recall period. Study visits took place at baseline, 3 month, and 6 month timepoints.
Serodiscordant defined as having partner of discordant or of unknown HIV serostatus."|Self-reported behavior during past 3 months|||Events in past 3 months|||Number
834488|NCT01279044|Primary|Unprotected Anal Intercourse Episodes With Three Most Recent Sex Partners at Each Follow-up Visit, Exclusive of Primary HIV-negative Partners.|"The outcome measure data shows the rate of change in the mean value of total unprotected anal intercourse episodes with three most recent sex partners over time. Behaviors were self-reported at each study visit using during the past 3 months as the recall period. Study visits took place at baseline, 3 month, and 6 month timepoints."|Self-reported behavior during past 3 months|||Episodes in past 3 months|||Number
834489|NCT01279044|Primary|Total Unprotected Anal Intercourse Partners|"The outcome measure data shows the rate of change in the mean value of total unprotected anal intercourse partners over time. Behaviors were self-reported at each study visit using during the past 3 months as the recall period. Study visits took place at baseline, 3 month, and 6 month timepoints."|Self-reported behavior during past 3 months|||Partners in past 3 months|||Number
834490|NCT01279044|Primary|Total Unprotected Anal Intercourse Events (Exclusive of Those Events With a Primary HIV-negative Partner)|"The outcome measure data shows the rate of change in the mean value in the number of total unprotected anal intercourse events over time. Behaviors were self-reported at each study visit using during the past 3 months as the recall period. Study visits took place at baseline, 3 month, and 6 month timepoints."|Self-reported behavior during past 3 months|||Self reported events in past 3 months|||Number
834491|NCT01279070|Secondary|Psychiatric Symptoms|The Spanish validation of the Positive and Negative Syndrome Scale (PANSS) was used for measuring positive, negative and general symptomatology. Total raw scoring obtained through the sum of the raw scores for each subscale was considered (min. 30–max. 210) with a score of 30 representing an absence of psychiatric symptoms.|Change from baseline in psychiatric symptoms scales at 40 weeks|||units on a scale||Standard Deviation|Mean
834492|NCT01279070|Secondary|Psychiatric Symptoms|The Spanish validation of the Positive and Negative Syndrome Scale (PANSS) was used for measuring positive, negative and general symptomatology. Total raw scoring obtained through the sum of the raw scores for each subscale was considered (min. 30–max. 210) with a score of 30 representing an absence of psychiatric symptoms.|Change from baseline in psychiatric symptoms scales at 16 weeks|||units on a scale||Standard Deviation|Mean
834493|NCT01279070|Secondary|Psychosocial Functioning|"The Spanish validation of the Life Skills Profile (LSP)was used. This scale measures functionality in daily life activities such as self-care, social behavior and autonomy. Raw scoring was used for the various subscales which are summarized for the total (min. 39–max. 156) with a higher score indicating a better result.
The 5 subscales are: Self-care, Non-turbulence, Social contact, Communication and Responsibility. We used the Spanish validation of the Social Functioning Scale (SFS)for measuring social behavior and relationships, autonomy, employment-occupation and leisure. Raw scoring was used for each subscale and for total score (min. 0–max. 223) with a higher score indicating a better result. All 7 subscales were administered: social engagement/ withdrawal, interpersonal behavior, independence-competence, independence-performance, pro-social activities, recreation and employment/ occupation."|Change from baseline in social functioning scales at 40 weeks|The sample size required was calculated according to the main study objective which consisted of achieving an improvement in social functioning according to the Living Skills Profile (LSP) scale. It was estimated that a sample of 27 patients per group would have a power of 80% at a significance level of 5% to detect these differences.||units on a scale||Standard Deviation|Mean
834494|NCT01279070|Secondary|Psychosocial Functioning|"The Spanish validation of the Life Skills Profile (LSP)was used. This scale measures functionality in daily life activities such as self-care, social behavior and autonomy. Raw scoring was used for the various subscales which are summarized for the total (min. 39–max. 156) with a higher score indicating a better result.
The 5 subscales are: Self-care, Non-turbulence, Social contact, Communication and Responsibility. We used the Spanish validation of the Social Functioning Scale (SFS)for measuring social behavior and relationships, autonomy, employment-occupation and leisure. Raw scoring was used for each subscale and for total score (min. 0–max. 223) with a higher score indicating a better result. All 7 subscales were administered: social engagement/ withdrawal, interpersonal behavior, independence-competence, independence-performance, pro-social activities, recreation and employment/ occupation."|Change from baseline in social functioning scales at 16 weeks|The sample size required was calculated according to the main study objective which consisted of achieving an improvement in social functioning according to the Living Skills Profile (LSP) scale. It was estimated that a sample of 27 patients per group would have a power of 80% at a significance level of 5% to detect these differences.||units on a scale||Standard Deviation|Mean
834495|NCT01279070|Primary|Executive Function|"Behavioral Assessment of the Dysexecutive Syndrome (BADS) (Wilson et al., 1996). This scale evaluates cognitive flexibility, inhibition of impulsive responses, planning and organization, working memory and time-estimation capacity. All subscales (Rule shift cards, Action Program, Key search, Temporal judgement, Zoo map and Six elements) were administered. We used subscales raw scores which run from 0 to 4. The subscales' raw score is summarized and converted to standardized total score which run (min.
12–max. 129). A higher score indicates better performance."|Change from baseline in executive functioning at 40 weeks|The sample size required was calculated according to the main study objective which consisted of achieving an improvement in social functioning according to the Living Skills Profile (LSP) scale. It was estimated that a sample of 27 patients per group would have a power of 80% at a significance level of 5% to detect these differences.||units on a scale||Standard Deviation|Mean
834496|NCT01279070|Primary|Executive Function|"Behavioral Assessment of the Dysexecutive Syndrome (BADS). This scale evaluates cognitive flexibility, inhibition of impulsive responses, planning and organization, working memory and time-estimation capacity. All subscales (Rule shift cards, Action Program, Key search, Temporal judgment, Zoo map and Six elements) were administered. We used subscales raw scores which run from 0 to 4. The subscales' raw score is summarized and converted to standardized total score which run (min.
12–max. 129). A higher score indicates better performance."|Change from baseline in executive function at 16 weeks (post-treatment)|The sample size required was calculated according to the main study objective which consisted of achieving an improvement in social functioning according to the Living Skills Profile (LSP) scale. It was estimated that a sample of 27 patients per group would have a power of 80% at a significance level of 5% to detect these differences.||units on a scale||Standard Deviation|Mean
834497|NCT01279109|Secondary|Social Network|Number of discussion partners within the intervention group. Participants were asked to identify by name any program participants with whom they had spoken about their pregnancy or pregnancy-related health behaviors.|2 times over 12 weeks (Week 6, Week 12)|59 participants in the intervention group completed at least one wave of social network data collection. Control group participants did not have protocol-specified group sessions to evaluate.||number of discussion partner ties||Standard Deviation|Mean
834498|NCT01279109|Primary|Gestational Weight Gain|"Total weight gain during pregnancy extracted from medical record, relative to the 2009 Institute of Medicine (IOM) Weight Gain Recommendations for Pregnancy.
(Reference: Institute of Medicine (US). Weight gain during pregnancy: reexamining the guidelines. Washington, DC. National Academies Press; 2009. 2009 National Academy of Sciences.)"|Duration of pregnancy|Analysis is presented within baseline BMI categories and overall. The Overall Number of Participants Analyzed represents those study participants for whom medical records could be abstracted in the trial (87/135).||Participants|||Count of Participants
834499|NCT01279200|Primary|Pregnancy Success Rate|Percentage of women in each arm who became pregnant within the study time frame.|3 menstrual/treatment cycles (approximately 28-33 days each)|||percentage of participants|||Number
834500|NCT01279200|Secondary|Time to Conception, Measured in Cycles|Cycles means treatment/menstrual cycles, approximately 28-33 days.|3 menstrual/treatment cycles, or upon conception, whichever comes first|Numbers of participants analyzed changes from 8 with kits and 4 with ultrasound (enrolled) because time to conception can be measured only for those who conceived, so the 6 and 1 participants analyzed here are those who were successful in getting pregnant.||menstrual cycles||Full Range|Mean
834501|NCT01279265|Secondary|Fecal Calprotectin|Test intestinal inflammation in the infants. Calprotectin is made by white blood cells called neutrophils. The number of neutrophils in the intestine is reflected by the fecal calprotectin level.|90 days|||µg/g (feces)||95% Confidence Interval|Mean
834502|NCT01279265|Secondary|Fecal Microbiota|Analyze and identify bacteria in the stool of the subjects. We will use pyrosequencing to characterize the bacteria colonizing the stool. We will measure diversity by Shannon's diversity index in the two groups.|90 days|||Shannon's diversity index value||Standard Deviation|Mean
835074|NCT01282801|Secondary|Cmax of O-Desmethylvenlafaxine.|Informational comparison of Cmax values for the metabolite O-Desmethylvenlafaxine.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
834503|NCT01279265|Primary|Daily Average Crying and Fussing Duration According to Barr Diary Records|The parent or guardian will complete a Barr diary to measure crying and fussing times of colicky infants . It is a daily timeline that records the number of minutes in five minute increments with fussiness and crying. The average colicky infant cries and fusses is more than 3 hours daily. If infants surpasses the 3 hours for more than three days (not consecutive) and are less than 3 months of age, they are considered to have colic.|90 days|||minutes||95% Confidence Interval|Mean
834504|NCT01279317|Primary|Postprandial Glycemic Incremental Area Under the Curve|area under the plasma glucose concentration curve, above the baseline plasma glucose, measured over 2 hr following ingestion of a the intervention beverages|2 hr|all subjects completed study and are included in analysis||mmol/L / 2hr||Standard Error|Mean
834505|NCT01279447|Primary|Post op Pain Score|immediate postop pain score, Visual Analog Scale. Evaluates pain on scale from 0-10. 0=no pain. 10=maximum pain.|0 hours|||units on a scale||Standard Deviation|Mean
834506|NCT01279564|Primary|Duration of Endotracheal Intubation|Time between introducing the laryngoscope and inflation of tube's cuff|The induction of general anesthesia, on the operating day (first day)|||seconds||Standard Deviation|Mean
834507|NCT01279564|Primary|In the Present Study we Will Compare the Performance Parameters of Intubation Using Etview Tracheoscopic Ventilation Tube - TVT to the Standard Tube||1 year||||||
834508|NCT01280110|Secondary|Macular Thickness|Macular thickness will be measured with an Optical coherence tomography (OCT). Measures 5% under the normal population according to the OCT software will be considered break in the blood-retina barrier.|Baseline, 15 days and 30 days.|Statiscal power of 80%||μm||Standard Deviation|Mean
834509|NCT01280110|Primary|Aqueous Humor Flare|Aqueous humor flare indicates the degree of a break in the blood-aqueous barrier. It is objectively measured with a Laser flare meter.|Baseline, 15 days and 30 days.|Statiscal power of 80%.||photons/msec||Standard Deviation|Mean
834510|NCT01280123|Secondary|Change in the 15-item Geriatric Depression Scale (GDS-15)From Baseline to 44 Weeks|The Geriatric Depression Scale - 15 is a short 15 yes or no question instrument for assessing depression in the elderly. It has been found to be particularly useful in assessing depression in Parkinson's Disease. A score of 0 to 5 is normal. A score greater than 5 suggests depression.|44 weeks|||units on a scale||95% Confidence Interval|Mean
834511|NCT01280123|Secondary|Change in the Mattis Dementia Rating Scale (DRS-2)From Baseline to 44 Weeks|The Mattis dementia rating scale is a psychometric instrument designed to assess the extent and nature of dementia. Mattis Dementia Rating scale (DRS-2) raw score is the sum of 5 raw sub-scores (attention has possible 37 points, initiation/perseveration has possible 37 points, construction has possible 6 points, conceptualization has possible 39 points, memory has possible 25 points). Total range is 0-144. Higher scores are better.|44 weeks|||units on a scale||95% Confidence Interval|Mean
834512|NCT01280123|Secondary|Change in Parkinson's Disease Questionnaire (PDQ-39) From Baseline to 44 Weeks|"The Parkinson's Disease Questionnaire (PDQ-39) is a short, 39 item measure of quality of life in subjects with Parkinson's disease. The questionnaire covers 8 aspects of quality of life: mobility, activities of daily living, emotional well-being, stigma, social support, cognitions, communication and bodily discomfort.
The total score ranges from 0 (never have difficulty) to 100 (always have difficulty). Lower scores reflect better quality of life."|44 weeks|||units on a scale||95% Confidence Interval|Mean
834513|NCT01280123|Secondary|Change in Schwab and England Scale From Baseline to 44 Weeks|The modified Schwab and England Activities of Daily Living is a single question ranging from 0-100% with anchors for each 10% interval. Higher scores are better (100% completely independent- 0% vegetative).|44 weeks|||units on a scale||95% Confidence Interval|Mean
834514|NCT01280123|Secondary|Change in Ambulatory Capacity From Baseline to 44 Weeks|"This is the sum of the 5 UPDRS questions regarding ambulatory capacity: falling, freezing, walking, gait, postural stability.
Ambulatory Capacity is calculated as the sum of items 13-15, 29, 30 of the Unified Parkinson's Disease Rating Scale (UPDRS). It ranges from 0-20. Higher scores are worse. Change is 44 weeks - baseline."|44 weeks|||units on a scale||95% Confidence Interval|Mean
834515|NCT01280123|Primary|Change in Total Unified Parkinson's Disease Rating Scale (UPDRS) Score From Baseline to 44 Weeks|"Change in total UPDRS score from baseline to 44 weeks (in subjects treated with rasagiline 1 mg/day or selegiline 10 mg/day).
The Total UPDRS is the sum of parts I, II, and III. The possible range of the total UPDRS is from 0-176. Higher values indicate worse outcomes.
The change is 44 weeks - baseline."|44 weeks|||units on a scale||Standard Error|Mean
834516|NCT01280266|Secondary|Dorsal-digital-difference.|The temperature difference between finger tips and dorsum of same hand. range 0 - unlimited in degree celcius.|baseline and 4 weeks|||degree celcius.||Standard Deviation|Mean
834517|NCT01280266|Secondary|Time-averaged Peak Velocity (cm/Sec)|changes in the averaged blood flow (Time-averaged peak velocity) Blood flow in cm/sec 0 - unlimited.|baseline and 4 weeks|||cm/sec||Standard Deviation|Mean
834518|NCT01280266|Secondary|Change in Peak Systolic Flow (cm/Sec)|"Change in digital artery flow velocity in proper palmar digital artery in cm/sec.
0-unlimited"|baseline and 4 weeks|||cm/sec||Standard Deviation|Mean
834519|NCT01280266|Secondary|Change in Digital Ulcer Number|0 - unlimited. Number of digital ulcers in all fingers are counted by the investigators and recorded at each visit. The number of ulcers in all fingers indirectly reflect the extent of critical ischemia. As such. the decrease in digital ulcer number reflects positive response to treatment (=better blood flow), whereas the increase ulcer numbers indicates worsening finger ischemia from baseline.|baseline and 4 weeks|||Digital ulcers||Standard Deviation|Mean
834520|NCT01280266|Secondary|Change in Physician's Global Assessment on Visual Analogue Scale (VAS)|"Physician's global assessment (PGA) on VAS assesses the overall condition of the patient. The scale ranges from 0 - 10, with 0 being good and 10 bad. As such, change in the GPA measures the change in the patient's condition from the baseline.
negative value (decrease in value) means improvement."|at 0 (baseline) and 4 weeks (after treatment)|||units on a scale||Standard Deviation|Mean
834521|NCT01280266|Secondary|Change in Health Assessment Questionnaire (HAQ)|Ordinal scale 0-10 0 good 10 bad|0 and 4 weeks|||units on a scale||Standard Deviation|Mean
834522|NCT01280266|Secondary|Change in the RP Duration|Change in the average RP duration in minutes (min) per attack. 0 -- unlimited|baseline and 4 weeks|||min per attack||Standard Deviation|Mean
835185|NCT01270958|Primary|Glucose Value at Baseline and After Treatment Completion|Glucose is a simple sugar used as a source of energy for cellular metabolism. Normal range: 3.9-6.4 mmol/L.|Baseline and treatment completion (up to Week 6)|ITT Population||mmol/L||Standard Deviation|Mean
834523|NCT01280266|Secondary|Change in Raynaud's Condition Score (RCS)|"change in the RCS. RCS combines daily activty, frequency, duration and severity as well as impact of RP attack (Measuring disease activity and functional status in patients with scleroderma and Raynaud's phenomenon, Merkel et al,Arthritis Rheum. 2002 Sep;46(9):2410-20).
Range 0-10 ordinal scale 0..good 10.. bad"|baseline and 4 weeks|||units on a scale||Standard Deviation|Mean
834524|NCT01280266|Primary|RP Attacks Per Day|Change in RP frequency after amlodipine and udenafil number of RP attack per day 0 -- unlimited.|baselin and 4 weeks|14 patients in UA arm + 12 patients in AU arm||attacks per day||Standard Deviation|Mean
834525|NCT01270126|Secondary|Other Visual and EEG Parameters|Secondary outcome parameters included DA in static and kinetic perimetry, reaction time (RT) in HRP, visual acuity (VA), contrast vision, and EEG power spectra.|Nov 2006 - Dec 2010||||||
834526|NCT01270126|Primary|Detection Accuracy (DA) Change in Percent Over Baseline Within Defective Visual Field Sectors|Central visual fields were assessed with computer-based high-resolution perimetry (HRP). Based on such plots, areas of the visual field were characterized as intact, partially damaged or absolutely impaired (blind). Detection accuracy (DA) change in percent above baseline within defective visual field sectors was defined as the primary outcome criterion.|Initial diagnostics (baseline), Post diagnostics|||percent change||Standard Deviation|Mean
834527|NCT01270139|Secondary|Mean Number of Membrane Defects on Membrane of Red Blood Cells|Mean number of membrane defects on membrane of red blood cells calculated with atomic force microscopy (AFM) in random patients. An amendment to the protocol was approved on August 29th 2012 with a decision to extend a 1-year study for another 4 years with the assessment of the 5-year clinical outcomes both retro- and prospectively.|at 60 months follow-up|The analysis was undergone in eligible random evaluable patients. Only one random patient with exposure of gold nanoparticles was selected for a trial-balloon analysis of cytotoxicity. The blood was collected and split blindly into two ex-vivo experiments with AFM microscopy (see description).||Mean number of membrane defects per cell|Area of blood sample per patient||Number
834528|NCT01270139|Secondary|TVR (Target Vessel Revascularization)|TVR (target vessel revascularization) reflects per cent of patients with TVR. An amendment to the protocol was approved on August 29th 2012 with a decision to extend a 1-year study for another 4 years with the assessment of the 5-year clinical outcomes both retro- and prospectively.|at 60 months follow-up|The per-treatment-evaluable analysis was performed at 60 months.||Participants|||Count of Participants
834529|NCT01270139|Secondary|TLR (Target Lesion Revascularization)|TLR (target lesion revascularization) reflects per cent of patients with TLR. An amendment to the protocol was approved on August 29th 2012 with a decision to extend a 1-year study for another 4 years with the assessment of the 5-year clinical outcomes both retro- and prospectively.|at 60 months follow-up|The per-treatment-evaluable analysis was performed at 60 months.||Participants|||Count of Participants
834530|NCT01270139|Secondary|Cardiac Death|Cardiac death includes per cent of patients passed away due to any cardiac death. An amendment to the protocol was approved on August 29th 2012 with a decision to extend a 1-year study for another 4 years with the assessment of the 5-year clinical outcomes both retro- and prospectively.|at 60 months follow-up|The per-treatment-evaluable analysis was performed at 60 months.||Participants|||Count of Participants
834531|NCT01270139|Secondary|MACE|MACE includes per cent of patients with cardiac death. STEMI (ST-elevation myocardial infarction), non-STEMI, and TLR (target lesion revascularization). An amendment to the protocol was approved on August 29th 2012 with a decision to extend a 1-year study for another 4 years with the assessment of the 5-year clinical outcomes both retro- and prospectively.|at 60 months follow-up|The intention-to-treat analysis was performed at 60 months.||Percentage of participants with MACE|||Number
834532|NCT01270139|Secondary|Minimal Lumen Diameter|Minimal lumen diameter (MLD, mm)|at 12-month follow-up|The intention-to-treat analysis||mm||Standard Deviation|Mean
834533|NCT01270139|Secondary|Per Cent of Calcium|IVUS (intravascular ultrasound) and IVUS-VH (virtual histology) images were acquired simultaneously with a phased array 20 MHz intravascular ultrasound catheter EagleEye (Volcano Co., Rancho Cordova, CA, USA) with motorized pull-back at a constant speed of 0.5 mm/s. Four tissue components (necrotic core - red; dense calcium - white; fibrous - green; and fibro-fatty - light green or yellow) were identified with autoregressive classification systems. For each cross section stent struts were detected as areas of apparent dense calcium and necrotic core. All IVUS analysis was performed offline by a CoreLab of the Ural Institute of Cardiology.|at 12-month follow-up|The intention-to-treat analysis||Percentage of tissue||Standard Deviation|Mean
834534|NCT01270139|Secondary|Per Cent of Necrotic Core|IVUS (intravascular ultrasound) and IVUS-VH (virtual histology) images were acquired simultaneously with a phased array 20 MHz intravascular ultrasound catheter EagleEye (Volcano Co., Rancho Cordova, CA, USA) with motorized pull-back at a constant speed of 0.5 mm/s. Four tissue components (necrotic core - red; dense calcium - white; fibrous - green; and fibro-fatty - light green or yellow) were identified with autoregressive classification systems. For each cross section stent struts were detected as areas of apparent dense calcium and necrotic core. All IVUS analysis was performed offline by a CoreLab of the Ural Institute of Cardiology.|at 12-month follow-up|The intention-to-treat analysis||Percentage of tissue||Standard Deviation|Mean
834535|NCT01270139|Secondary|Per Cent of Fibrous Component|IVUS (intravascular ultrasound) and IVUS-VH (virtual histology) images were acquired simultaneously with a phased array 20 MHz intravascular ultrasound catheter EagleEye (Volcano Co., Rancho Cordova, CA, USA) with motorized pull-back at a constant speed of 0.5 mm/s. Four tissue components (necrotic core – red; dense calcium – white; fibrous – green; and fibro-fatty – light green or yellow) were identified with autoregressive classification systems. For each cross section stent struts were detected as areas of apparent dense calcium and necrotic core. All IVUS analysis was performed offline by a CoreLab of the Ural Institute of Cardiology.|at 12-month follow-up|The intention-to-treat analysis||Percentage of tissue||Standard Deviation|Mean
834536|NCT01270139|Secondary|Target Lesion Revascularization|Target lesion revascularization, per cent|at 12-month follow-up|The intention-to-treat analysis||Percentage of participants|||Number
834577|NCT01270620|Primary|Trail Making Part B|Trail Making Test is an executive measure of sequencing and cognitive flexibility. Trail B is a more difficult cognitive flexibility task requiring the subject to follow a sequential pattern while shifting cognitive sets and reflects executive functioning, although other cognitive abilities, such as psychomotor speed and visual scanning, are necessary for successful completion of the task. The scoring for this test is the time in seconds required for completion of the test|Change > 20% from baseline to 48 hours after surgery|||participants|||Number
834537|NCT01270139|Secondary|Per Cent Atheroma Volume|Per cent atheroma volume (PAV, plaque burden, %). Quantitative coronary angiography (QCA) and Intravascular Ultrasound (IVUS) were performed pre-, post-procedure and at 12-month follow-up after a bolus infusion of i.c. nitrate. QCA was undergone with the CAAS II analysis system (Pie Medical B.V., Maastricht, The Netherlands) with analysis of different QCA parameters such as minimal lumen diameter, maximum lumen diameter, reference diameter, diameter stenosis, lesion length, percent atheroma volume (PAV), total atheroma volume (TAV), and lumen volume.|at 12-month follow-up|The intention-to-treat analysis||Percentage of tissue||Standard Deviation|Mean
834538|NCT01270139|Secondary|Coronary Vasomotion - Mean Lumen Diameter After Infusion of Acetylcholine 10-6 M|Coronary vasomotion was assessed with QCA. End-diastolic images of coronary arteries were evaluated at baseline, after intravascular infusion of acetylcholine (through a microcatheter at increasing doses up to 10-8, 10-7, 10-6 M with a washout period of at least five minutes between each dose), and after nitroglycerine application following acetylcholine (100 µg orally). In all patients, measurements were performed in two segments on site of intervention while 960 seconds. The artery diameter was calibrated against the contrast-filled tip of the catheter. Vasoconstriction to acetylcholine was defined as a 3% change of the mean lumen diameter after infusion of the maximal dose of acetylcholine. An investigator blinded to treatment group performed all measurements.|at 12-month follow-up|The intention-to-treat analysis||mm||Standard Deviation|Mean
834539|NCT01270139|Secondary|Late Definite Thrombosis|Late definite thrombosis rate|at 12-month follow-up|The intention-to-treat analysis||Percentage of participants|||Number
834540|NCT01270139|Secondary|Restenosis Rate|Restenosis (stenosis>50%) rate|at 12-month follow-up|The intention-to-treat analysis||Percentage of patients|||Number
834541|NCT01270139|Secondary|Event Free Survival|The Kaplan-Meier analysis of the cardiac event-free survival (failure-free survival). The end point in this study was cardiac event-free survival during follow-up, starting at randomization. Cardiac events included cardiac death, myocardial infarction and unintended revascularization. Cardiac death was defined as sudden death, death after the onset of symptoms suggestive of cardiac ischemia and death due to heart failure. Noncardiac death was defined as death due to all other causes. Myocardial infarction was defined as an increase in cardiac enzymes or new pathologic Q-waves on the ECG, or both. Unintended revascularization was defined as PTCA or CABG performed due to worsening of the patient’s clinical condition, rather than the PTCA or CABG assigned by the revascularization team when patient management was determined.|at 12-month follow-up|The intention-to-treat analysis||Percentage of survived patients|||Number
834542|NCT01270139|Secondary|Per Cent of Fibro-fatty Component|IVUS (intravascular ultrasound) and IVUS-VH (virtual histology) images were acquired simultaneously with a phased array 20 MHz intravascular ultrasound catheter EagleEye (Volcano Co., Rancho Cordova, CA, USA) with motorized pull-back at a constant speed of 0.5 mm/s. Four tissue components (necrotic core - red; dense calcium - white; fibrous - green; and fibro-fatty - light green or yellow) were identified with autoregressive classification systems. For each cross section stent struts were detected as areas of apparent dense calcium and necrotic core. All IVUS analysis was performed offline by a CoreLab of the Ural Institute of Cardiology.|at 12-month follow-up|The intention-to-treat analysis||Percentage of tissue||Standard Deviation|Mean
834543|NCT01270139|Primary|MACE (Major Adverse Cardiovascular Events)-Free Survival|MACE (major adverse cardiovascular events)-free survival reflects per cent of survived patients without MACE. An amendment to the protocol was approved on August 29th 2012 with a decision to extend a 1-year study for another 4 years with the assessment of the 5-year clinical outcomes both retro- and prospectively.|at 60 months follow-up|Some patients were lost to follow-up at 5 years and were not included to the final analysis. The intention-to-treat analysis was performed at 60 months.||Percentage of survivors without MACE|||Number
834544|NCT01270139|Primary|Total Atheroma Volume|Total atheroma volume (TAV, plaque-media volume, mm3) at 12 months. Quantitative coronary angiography (QCA) and Intravascular Ultrasound (IVUS) were performed pre-, post-procedure and at 12-month follow-up after a bolus infusion of i.c. nitrate. QCA was undergone with the CAAS II analysis system (Pie Medical B.V., Maastricht, The Netherlands) with analysis of different QCA parameters such as minimal lumen diameter, maximum lumen diameter, reference diameter, diameter stenosis, lesion length, percent atheroma volume (PAV), total atheroma volume (TAV), and lumen volume.|at 12-month follow-up|The intention-to-treat-population analysis||mm3||Standard Deviation|Mean
834545|NCT01270256|Primary|Change in Nasal Peak Inspiratory Flow (NPIF)|NPIF was measured objectively in liters per minute with an In-Check Peak & Inspiratory Flow Meter (Ferraris Medical Inc, Orchard Park, NY). Subjects obtained 3 readings every morning and every evening and the greatest of the 3 measures were recorded. Total daily NPIF was calculated by adding the morning and evening values each day and the average of the change from baseline in NPIF for all days of was calculated|Baseline and 26 days|||liters/min||Standard Error|Median
834546|NCT01270464|Secondary|Participants With a Positive Anti-Reslizumab Antibody Status at Baseline, Week 8, Week 16, Endpoint, and Overall|"Counts of participants with a positive anti-drug antibody (ADA) response during treatment is offered for the two experimental treatment arms. Blood samples were collected for determination of ADAs before study drug infusion at baseline, visit 4 (week 8), and at visit 6 (week 16: EOT or early withdrawal) from patients in all 3 treatment groups (ie, placebo, 0.3 mg/kg reslizumab, and 3.0 mg/kg reslizumab); however, only the blood samples drawn from patients treated with either 0.3 mg/kg reslizumab or 3.0 mg/kg reslizumab were analyzed. Serum samples from patients who were treated with reslizumab were analyzed for ADA by Teva (Teva Biopharmaceuticals USA, Rockville, MD) using a validated homogeneous solution-based bridging enzyme-linked immunosorbent assay (ELISA).
Endpoint =week 16 or early withdrawal."|Day 1 (pre-dose), week 8, 16 and endpoint|Pharmacokinetic analysis set. Anti-Reslizumab antibody status was not analyzed for patients in the Placebo treatment arm.||participants|||Number
834547|NCT01270464|Secondary|Shifts From Baseline to Endpoint in Electrocardiogram Findings|Participant counts in each category of shift from baseline to endpoint of ECG finding. Findings summarized as normal or abnormal.|Weeks -4 to -2 (Screening Visit), Week 16|Safety analysis set of participants with both baseline and endpoint values.||participants|||Number
834626|NCT01271803|Primary|Maximum Plasma Concentration (Cmax) of Cobimetinib on Day 1, Cycle 1||Cycle 1: predose (0 hours [hr]) on Days 1, 2; 0.5, 1, 2, 4, 6 hr postdose on Day 1|PK population included all participants who received study treatment and had at least one vemurafenib and cobimetinib plasma concentration available. Here, number of participants analyzed = participants who were evaluable for this outcome.||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
834548|NCT01270464|Secondary|Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Vital Signs Values|"Data represents participants with potentially clinically significant (PCS) vital sign values.
Significance criteria
Sitting pulse - high: >100 and increase of >= 30 beats/minute
Sitting pulse - low: <50 and decrease of >=30 beats/minute
Sitting diastolic blood pressure: >100 and increase of >=12 mmHg
Respiration rate: >24 and increase of >=10 breaths/minute
Body temperature: <96.5° Fahrenheit or <35.8° Celsius
The last postbaseline value for approximately 10 patients in each treatment group is the 90-day follow-up visit post end-of-treatment (approx. Week 29)."|Day 2 to Week 29|Safety analysis set||participants|||Number
834549|NCT01270464|Secondary|Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Abnormal Lab Values|"Data represents participants with potentially clinically significant (PCS) abnormal serum chemistry, hematology (except for eosinophil values), and urinalysis values.
Significance criteria:
Blood urea nitrogen: >=10.71 mmol/L
Creatinine: >=177 μmol/L
Uric acid: M>=625, F>=506 μmol/L
GGT = gamma-glutamyl transpeptidase: >= 3*upper limit of normal. Normal range is 5-49 U/L.
Total bilirubin: >=34.2 μmol/L
White blood cells: <=3.0 10^9/L
Hemoglobin: M<=115, F<=95 g/dL
Hematocrit: M<0.37, F<0.32 %
Platelets: >=700 10^9/L
Absolute neutrophil count: <=1.0 10^9/L
Urinalysis: blood, glucose, ketones and total protein: >=2 unit increase from baseline
The last postbaseline value for approximately 10 patients in each treatment group is the 90-day follow-up visit post end-of-treatment (approx. Week 29)."|Day 2 to Week 29|Safety analysis set||participants|||Number
834550|NCT01270464|Secondary|Participants With Adverse Events|An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an inability to carry out usual activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes. The last postbaseline value for approximately 10 patients in each treatment group is the 90-day follow-up visit post end-of-treatment (approx. Week 29).|Day 1 (post-dose) to Week 29|Safety analysis set||participants|||Number
834551|NCT01270464|Secondary|Change From Baseline in Blood Eosinophil Count Over 16 Weeks Using Mixed Model for Repeated Measures|"Blood eosinophil counts were measured using a standard complete blood count (CBC) with differential blood test at each scheduled visit, and from all patients experiencing a serious adverse event, an adverse event leading to withdrawal, or an exacerbation of asthma symptoms. The during treatment (weeks 4, 8, 12 and 16) average eosinophil counts were estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.
Negative change from baseline values correlate to reduced asthma severity."|Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16|Full analysis set, including patients who contributed at least once to the analysis.||10^9 blood eosinophil/L||Standard Error|Least Squares Mean
834552|NCT01270464|Secondary|Change From Baseline in Short-Acting Beta-Agonist (SABA) Use Over 16 Weeks Using Mixed Model for Repeated Measures|"SABA are used for quick relief of asthma symptoms. To measure SABA use, at each clinical visit patients were asked to recall their usage of SABA therapy within the last 3 days of the scheduled visit. If usage was confirmed, the number of puffs used was recorded. For the purpose of summaries, an average daily usage was evaluated by dividing the total number of puffs recorded over 3 days by 3.
The during treatment (weeks 4, 8, 12 and 16) average SABA use was estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.
Negative change from baseline scores indicate improvement in asthma control."|Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16|Full analysis set, including patients who contributed at least once to the analysis.||SABA puffs per day||Standard Error|Least Squares Mean
834553|NCT01270464|Secondary|Change From Baseline in Asthma Symptom Utility Index (ASUI) Over 16 Weeks Using Mixed Model for Repeated Measures|"The ASUI is an 11-item instrument designed to assess the frequency and severity of asthma symptoms and side effects, weighted by patient preferences (Revicki et al 1998). ASUI is a utility score that ranges from 0 to 1, with higher values indicating better asthma control. The during treatment (weeks 4, 8, 12 and 16) average ASUI was estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.
Positive change from baseline values indicate improvement in asthma symptoms. Information was obtained from questionnaire about asthma symptoms."|Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16|Full analysis set, including patients who contributed at least once to the analysis.||units on a scale||Standard Error|Least Squares Mean
834554|NCT01270464|Secondary|Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) at Week 16 or at Last Observed Value|"The AQLQ is a 32-item instrument administered as a self-assessment (Juniper et al 1992). The questionnaire is divided into 4 domains: activity limitation, symptoms, emotional function, and environmental stimuli. Patients were asked to recall their experiences during the last 2 weeks and to respond to each question on a 7-point scale (1=severe impairment, 7=no impairment). The overall AQLQ score is the mean of all 32 responses. Five of the activity questions were “patient-specific,” which means that each patient identified and scored 5 activities in which the patient was limited by asthma; these 5 activities were identified at the first visit and retained for all subsequent follow-up visits.
Positive change from baseline scores indicate improvement in quality of life. The AQLQ score was only assessed once during the study at week 16 or at early withdrawal, i.e. last postbaseline assessment if within 3 to 5 weeks of the last dose of study drug."|Day 1 (baseline, pre-dose), Week 16 or last observed value|Full analysis set of participants with assessments at stated timeframes.||units on a scale||Standard Error|Least Squares Mean
834641|NCT01271946|Primary|Major Adverse Events Reported as Percentage of Participants With Adverse Events.|Observation of any major access site-related complication (percentage of participants).|Procedure through 30 day follow-up.|||Percentage of participants|||Number
834642|NCT01271946|Primary|Observation of Any Site Related Complications Recorded as Either Major or Minor Adverse Events.||Procedure through 30 days follow-up.||||||
834555|NCT01270464|Secondary|Change From Baseline in Asthma Control Questionnaire (ACQ) Over 16 Weeks Using Mixed Model for Repeated Measures|"The ACQ is a 7-item instrument that measures asthma control (Juniper et al 1999). Six questions are self-assessments; the seventh item, completed by a member of the study staff, is the result of the patient’s FEV1 measurement. Each item has 7 possible answers on a scale of 0 to 6, and the total score is the mean of all responses (the total scale is therefore 0-6). A higher score is an indication of poorer asthma control. The during treatment (weeks 4, 8, 12 and 16) average ACQ was estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.
Negative change from baseline scores indicate improvement in asthma control."|Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16|Full analysis set, including participants who contributed at least once to the analysis.||units on a scale||Standard Error|Least Squares Mean
834556|NCT01270464|Secondary|Change From Baseline in % Predicted Expiratory Volume In 1 Second (FEV1) at Week 16 and at Endpoint|The percent predicted FEV1 is the ratio of the volume of air expired in the first second of a forced expiration to the patient's predicted FEV based on a similar population without asthma. Endpoint =week 16 or early withdrawal.|Day 1 (baseline, pre-dose), Week 16, endpoint|Full analysis set of participants with assessments at stated timeframes.||percentage of predicted FEV1||Standard Deviation|Mean
834557|NCT01270464|Secondary|Change From Baseline in Forced Expiratory Flow at 25% to 75% Forced Vital Capacity (FEF 25%-75%) Over 16 Weeks Using Mixed Model for Repeated Measures|The FEF 25%-75% is the force expiratory flow at 25% to 75% of the Forced Vital Capacity (FVC). The during treatment (weeks 4, 8, 12 and 16) average FEF 25%-75% was estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.|Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16|Full analysis set. Number of participants analyzed includes those who contributed at least once to the analysis.||liters/second||Standard Error|Least Squares Mean
834558|NCT01270464|Secondary|Change From Baseline in Forced Vital Capacity (FVC) Over 16 Weeks Using Mixed Model for Repeated Measures|The FVC is the volume of air that can be forcibly blown out after full inspiration, measured in liters. The during treatment (weeks 4, 8, 12 and 16) average FVC was estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.|Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16|Full analysis set. Number of participants analyzed includes those who contributed at least once to the analysis.||liters||Standard Error|Least Squares Mean
834559|NCT01270464|Primary|Change From Baseline In Forced Expiratory Volume In 1 Second (FEV1) Over 16 Weeks Using Mixed Model for Repeated Measures|"FEV1 is a standard measurement of air movement in the lungs of patients with asthma obtained from pulmonary function tests. It is the volume of air expired in the first second of a forced expiration using a spirometer. The during treatment (weeks 4, 8, 12 and 16) average FEV1 was estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.
Positive change from baseline scores indicate improvement in asthma control."|Day 0 (baseline, pre-dose), Weeks 4, 8, 12 and 16|Full analysis set-all patients randomly assigned to treatment and treated with at least 1 dose of study drug. Number of participants analyzed includes those who contributed at least once to the analysis.||liters||Standard Error|Least Squares Mean
834560|NCT01270503|Secondary|Number of Subjects Reporting Non-serious Related Adverse Events Not Listed in Prescribing Information (PI) Following Vaccination With Menactra®||Day 0 up to Day 30 post-vaccination|Post-vaccination safety were assessed in the Safety Analysis Set.||Participants|||Number
834561|NCT01270503|Primary|Safety Overview Within 30 Days in Participants Vaccinated With Menactra®||Day 0 up to Day 30 post-vaccination|Post-vaccination safety were assessed in the Safety Analysis Set.||Participants|||Number
834562|NCT01270529|Primary|Change in Physical Activity|Participants will measure physical activity in the form of daily steps using a pedometer|Baseline, 12 weeks|||change in steps per day||95% Confidence Interval|Mean
834563|NCT01270542|Secondary|Improvement of Visual Outcomes in Patients Given Pre-operative Adjunctive Bevacizumab in Eyes Undergoing PDR Surgery.|Measured by median logMAR change in the best corrected visual acuity (VA) from baseline to post operative month 3 (POM3)|3 months from last surgery|||logMAR|Eyes|Full Range|Median
834564|NCT01270542|Secondary|Whether Intra- and Post-operative Complications Are Decreased in Eyes Given Pre-operative Adjunctive Bevacizumab in Eyes Undergoing Proliferative Form of Diabetic Retinopathy (PDR) Surgery.||3 months after last surgery.|||Eyes|Eyes||Count of Units
834565|NCT01270542|Primary|The Effect of an Anti-VEGF (Vascular Endothelial Growth Factor) Agent, Bevacizumab, on Levels of Vitreous and Aqueous Growth Factor Levels (pg/mL) in Eyes With Traction Retinal Detachment Due to PDR|Comparison of vitreous VEGF levels (pg/mL) and aqueous VEGF (pg/mL) levels in bevacizumab and control groups.|3 months after last surgery|||pg/mL|Eyes|Full Range|Median
834566|NCT01270555|Secondary|Beck Depression Inventory (BDI)|minimum score (least severe depression) = 0, maximum score (most severe) = 63|baseline and six weeks|||Units on a scale||Standard Deviation|Mean
834567|NCT01270555|Secondary|Hamilton Depression Scale (HAM-D)|minimum score (least severe depression) = 0, maximum score (most severe) = 84|baseline and six weeks|||Units on a scale||Standard Deviation|Mean
834568|NCT01270555|Secondary|Hamilton Anxiety Scale (HAM-A)|minimum score (least severe anxiety) = 0, maximum (most severe) = 56|baseline and six weeks|||Units on a scale||Standard Deviation|Mean
834569|NCT01270555|Primary|Self-reported Weekly Substance Use|Number of subjects who self-report using at least one of illegal drugs or alcohol, at least once in a week.|baseline and six weeks|||Participants|||Number
834570|NCT01270555|Secondary|Clinical Global Impressions (CGI) Scale of ADHD Severity|Global Severity (CGI-S) 1=not ill, 7=extremely ill|baseline and six weeks|||Units on a scale||Standard Deviation|Mean
834571|NCT01270555|Secondary|Clinical Global Impressions (CGI) Scale of Substance Use Disorder (SUD) Severity|CGI-S 1=not ill, 7=extremely ill|baseline and six weeks|||Units on a scale||Standard Deviation|Mean
834578|NCT01270620|Primary|Trail Making Part B|• Trail Making Test is an executive measure of sequencing and cognitive flexibility. Trail B is a more difficult cognitive flexibility task requiring the subject to follow a sequential pattern while shifting cognitive sets and reflects executive functioning, although other cognitive abilities, such as psychomotor speed and visual scanning, are necessary for successful completion of the task. The scoring for this test is the time in seconds required for completion of the test|Change > 20% from baseline to 6-8 hours after surgery|||participants|||Number
834579|NCT01270620|Primary|Trail Making Part A|• Trail Making Test is an executive measure of sequencing and cognitive flexibility. Trail A requires the subject to rapidly sequence a straightforward series. The scoring for this test is the time in seconds required for completion of the test|Change > 20% from baseline to 48 hours after surgery|||participants|||Number
834580|NCT01270620|Primary|Trail Making Part A|• Trail Making Test is an executive measure of sequencing and cognitive flexibility. Trail A requires the subject to rapidly sequence a straightforward series. The scoring for this test is the time in seconds required for completion of the test|Change > 20% from baseline to 6-8 hours after surgery|||participants|||Number
834581|NCT01270620|Primary|Digit Symbol Substitution Test|• The Digit Symbol Substitution Test (DSST) measures attention, working memory, sustained visual attention and psychomotor speed. Subjects are given a table that pairs digits and symbols, and asked to decipher a code using the table, completing as many as possible in 90 seconds. The DSST has been found to be more sensitive than other tests to changes in high-levels of cognition|Change > 20% from baseline to 48 hours after surgery|||participants|||Number
834582|NCT01270620|Primary|Digit Symbol Substitution Test|• The Digit Symbol Substitution Test (DSST) measures attention, working memory, sustained visual attention and psychomotor speed. Subjects are given a table that pairs digits and symbols, and asked to decipher a code using the table, completing as many as possible in 90 seconds. The DSST has been found to be more sensitive than other tests to changes in high-levels of cognition|Change > 20% from baseline to 6-8 hours after surgery|||participants|||Number
834583|NCT01270620|Primary|Recall of Digit Span|• The Digit Span subtest of the Wechsler Adult Intelligence Scale-Revised is a test that requires subjects to repeat a series of digits that have been verbally presented to them both forward and, in a later independent test, reverse order. It measures attention and working memory|Change > 20% from baseline to 48 hours after surgery|||participants|||Number
834584|NCT01270620|Primary|Recall of Digit Span|• The Digit Span subtest of the Wechsler Adult Intelligence Scale-Revised is a test that requires subjects to repeat a series of digits that have been verbally presented to them both forward and, in a later independent test, reverse order. It measures attention and working memory|Change > 20% from baseline to 6-8 hours after surgery|||participants|||Number
834585|NCT01270620|Secondary|ProBNP||Change from baseline to post-operative day 2|||ng/L||Inter-Quartile Range|Median
834586|NCT01270620|Secondary|BNP||Change form baseline to post-operative day 2|||ng/L||Inter-Quartile Range|Median
834587|NCT01270620|Secondary|Troponin I|Patients who had troponin level > 0.2 ng/mL|2 days|||participants|||Number
834588|NCT01270620|Secondary|N-terminal proBNP||Change from baseline to day one|||ng/L||Inter-Quartile Range|Median
834589|NCT01270620|Secondary|B-type Natriuretic Peptide||Change from Baseline to day one|||ng/L||Inter-Quartile Range|Median
834590|NCT01270620|Secondary|Recovery Room Time||first day|||minutes||Inter-Quartile Range|Median
834591|NCT01270620|Secondary|Nausea and Vomiting||48 hours|||participants|||Number
834592|NCT01270620|Secondary|- Time to Following Command After Desflurane/Propofol Discontinuation||first day|||seconds||Inter-Quartile Range|Median
834593|NCT01270620|Secondary|- Time to Tracheal Extubation After Desflurane/Propofol Discontinuation||first day|||seconds||Inter-Quartile Range|Median
834594|NCT01270620|Secondary|- Time to Eye Opening After Desflurane/Propofol Discontinuation||first day|||seconds||Inter-Quartile Range|Median
834595|NCT01270620|Secondary|- Time to Spontaneous Breathing After Desflurane/Propofol Discontinuation||first day|||seconds||Inter-Quartile Range|Median
834596|NCT01270620|Primary|Assessment of Delirium|The primary end point was the incidence of postoperative delirium as measured by the Confusion Assessment Method (CAM).|48 hours|||participants|||Number
834597|NCT01271712|Secondary|Duration of Response (DOR)|Duration of Response was defined as the time from date of first response (Complete Response [CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target).] or Partial Response [PR: at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.]) to the date when Progressive Disease (PD: at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study or unequivocal progression of existing non-target lesions, or appearance of new lesions.) is first documented, or to the date of death, whichever occurs first, according to RECIST v1.1. Subjects still having CR or PR and have not died at the time of analysis were censored at their last date of tumor evaluation. Duration of response defined for responders only, i.e CR or PR. Results are based on central evaluation.|From randomization of the first subject until date of database cutoff (26 Jan 2012); study duration approximately 1 year|Full Analysis Set with response participants||Days||95% Confidence Interval|Median
834598|NCT01271712|Secondary|Disease Control Rate (DCR)|Disease Control Rate (DCR) was defined as the percentage of subjects whose best response was Complete Response (CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target).), Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.), or Stable Disease (SD: steady state of disease. Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.) according to RECIST v1.1 criteria. SD had to be maintained for at least 12 weeks from the first demonstration of that rating. Results are based on central evaluation.|From randomization of the first subject until date of database cutoff (26 Jan 2012); study duration approximately 1 year|Full Analysis Set (FAS)||Percentage of Participants||95% Confidence Interval|Number
834974|NCT01281917|Primary|Progression Free Survival|The primary objective of this study is to determine whether Velcade in combination with temsirolimus provides benefit to subjects with relapsed or refractory B-cell non-Hodgkin lymphoma as assessed by progression-free survival (PFS).|Up to 60 months|||Months||95% Confidence Interval|Median
834599|NCT01271712|Secondary|Objective Response Rate|Objective response rate was defined as the percentage of subjects whose best response was Complete Response (CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target).) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.) according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Results are based on central evaluation.|From randomization of the first subject until date of database cutoff (26 Jan 2012); study duration approximately 1 year.|Full Analysis Set (FAS)||Percentage of Participants||95% Confidence Interval|Number
834600|NCT01271712|Secondary|Tumor Response|Tumor Response of a subject was defined as the best tumor response (Complete Response [CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target).], Partial Response [PR: at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.], Stable Disease [SD: steady state of disease. Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.], or Progressive Disease [PD: at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study or unequivocal progression of existing non-target lesions, or appearance of new lesions.]) observed during the trial period and assessed according to RECIST v1.1 criteria. Results are based on central evaluation.|From randomization of the first subject until date of database cutoff (26 Jan 2012); study duration approximately 1 year|Full Analysis Set (FAS)||Percentage of Participants||95% Confidence Interval|Number
834601|NCT01271712|Secondary|Time to Progression (TTP)|Time to progression (TTP) was defined as the time from date of randomization to disease progression (based on central radiological assessment using modified RECIST [Response Evaluation Criteria in Solid Tumors] v.1.1). Progression is defined as at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study; or unequivocal progression of existing non-target lesions; or appearance of new lesions. Subjects without progression at the time of analysis were censored at their last date of tumor evaluation. Results are based on central evaluation.|From randomization of the first subject until until date of database cutoff (26 Jan 2012); study duration approximately 1 year|Full Analysis Set (FAS)||Days||95% Confidence Interval|Median
834602|NCT01271712|Secondary|Overall Survival|Overall Survival (OS) was defined as the time from date of randomization to death due to any cause. Subjects still alive at the time of analysis were censored at their date of last contact. Median OS was not observed at the time of PFS analysis and first analysis of OS, therefore only the proportion of death events was reported in the results posting system. This approach was maintained for the subsequent updates in the results posting system.|From randomization of the first subject until date of database cutoff (08 Jun 2015)|Full Analysis Set (FAS). 58 (87.9%) patients in placebo group and 91 (68.4%) patients in regorafenib had started open-label treatment with regorafenib before time of final database cutoff 08 Jun 2015||Percentage of patients with death|||Number
834603|NCT01271712|Primary|Progression-free Survival|Progression-free Survival (PFS) was defined as the time from date of randomization to radiological disease progression or death due to any cause, whichever occurs first. PFS was based on central radiological assessment using modified RECIST (Response Evaluation Criteria in Solid Tumors) v.1.1. Progression is defined as at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study; or unequivocal progression of existing non-target lesions; or appearance of new lesions. Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation. Results are based on central evaluation.|From randomization of the first subject until approximately 144 progression-free survival events had occurred (study duration approximately one year)|Full Analysis Set (FAS) - defined as all randomized participants.||Days||95% Confidence Interval|Median
834604|NCT01271803|Secondary|Pharmacodynamics: Number of Participants With Mitogen-Activated Protein Kinase (MAPK) Inhibition, as Assessed by Immunohistochemistry (IHC)|Changes in effector molecules of the MAPK pathway that are directly or indirectly affected by BRAF and MEK inhibition (including but not limited to ERK and phosphorylated ERK and MEK) by IHC using biopsies at baseline, between Days 10−14 of Cycle 1, and at disease progression. IHC is a staining process performed on fresh/frozen tumor tissue samples.|At baseline; Cycle 1: Day 14; at disease progression (Up to 32 months)|Number of participants analyzed=number of participants available for analysis of this outcome measure.||participants|||Number
834605|NCT01271803|Secondary|Average Percent Change From Baseline in Fluorodeoxyglucose-positron Emission Tomography (FDG-PET) at Cycle 1 and Cycle 2|The pharmacodynamic effect of cobimetinib in combination with vemurafenib was assessed by measuring changes in FDG uptake as characterized by the lean body mass corrected (LBM) maximum standardized uptake value (SUV max) measurement using FDG-PET. Post-baseline timepoint Cycle 1 was averaged between Days 10 to 14 and Cycle 2 for Days 14+7.|Cycle 1 (Days 10 to 14), Cycle 2 (Days 14+7)|Safety evaluable population who received combination study treatment (Cobimetinib + Vemurafenib) was included in the analysis of this outcome. Here, number of participants analyzed = participants who were evaluable for this outcome.||Percent change in FDG-PET||Standard Deviation|Mean
834606|NCT01271803|Secondary|Overall Survival (OS)|OS was defined as the time from the date of randomization to the date of death due to any cause. Participants were censored at the last date of tumor measurement, the last date in the study drug log, or the date of last follow-up. OS analyzed using Kaplan-Meier estimate.|Screening to up to data cut-off (01 October 2013) (assessed at screening [within 28 days prior to initiation of Cycle 1], every 6 weeks thereafter until disease progression or death or data cut-off [01 October 2013]) up to 32 months|Safety evaluable population who received combination study treatment (Cobimetinib + Vemurafenib) was included in the analysis of this outcome.||months||95% Confidence Interval|Median
834607|NCT01271803|Secondary|Median Duration of Response (DOR)|Duration of response, defined as the time from first occurrence of a documented objective response until the time of disease progression, as determined by investigator review of tumor assessments using RECIST v 1.1, or death from any cause during the study (that is within 30 days after the last dose of study treatment).|Screening to up to data cut-off (01 October 2013) (assessed at screening [within 28 days prior to initiation of Cycle 1], every 6 weeks thereafter until disease progression or death or data cut-off [01 October 2013]) up to 32 months|Safety evaluable population who received combination study treatment (Cobimetinib + Vemurafenib) and had an objective response (of CR or PR) was included in the analysis of this outcome.||months||95% Confidence Interval|Median
834608|NCT01271803|Secondary|Percentage of Participants With Disease Progression According to RECIST V 1.1|Progressive disease (PD) according to RECIST V 1.1: at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum on study (nadir), including baseline; in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm; appearance of 1 or more lesions is also considered as progression.|Screening to up to data cut-off (01 October 2013) (assessed at screening [within 28 days prior to initiation of Cycle 1], every 6 weeks thereafter until disease progression or death or data cut-off [01 October 2013]) up to 32 months|Safety evaluable population who received combination study treatment (Cobimetinib + Vemurafenib) was included in the analysis of this outcome.||percentage of participants|||Number
834609|NCT01271803|Secondary|Percentage of Participants With an Objective Response of Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version (V) 1.1|Tumor response of CR or PR is considered as objective response. CR: disappearance of all target lesions, reduction in short axis <10 millimeters in pathological lymph nodes (target and non-target lesions); PR: at least a 30 percent (%) decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Responses were confirmed by repeat assessments ≥4 weeks after initial documentation.|Screening to up to data cut-off (01 October 2013) (assessed at screening [within 28 days prior to initiation of Cycle 1], every 6 weeks thereafter until disease progression or death or data cut-off [01 October 2013]) up to 32 months|Safety evaluable population who received combination study treatment (Cobimetinib + Vemurafenib) was included in the analysis of this outcome.||percentage of participants||95% Confidence Interval|Number
834610|NCT01271803|Primary|Tmax of Vemurafenib on Day 14, Cycle 1||Predose (0 hr) on Days 14, 15; 0.5, 1, 2, 4, 6, 8 hr postdose on Day 14|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Median
834611|NCT01271803|Primary|Cmax of Vemurafenib on Day 14, Cycle 1||Predose (0 hr) on Days 14, 15; 0.5, 1, 2, 4, 6, 8 hr postdose on Day 14|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
834612|NCT01271803|Primary|Tmax of Vemurafenib on Day 1, Cycle 1 in BRAFi-naïve Participants||Predose (0 hr) on Day 1, 2; 0.5, 1, 2, 4, 6 hr postdose on Day 1|PK population. Here, number of participants analyzed = participants who were BRAFi-naïve participants.||hours||Full Range|Median
834613|NCT01271803|Primary|Cmax of Vemurafenib on Day 1, Cycle 1 in Cohort 1A in BRAFi-naïve Participants||Predose (0 hr) on Day 1, 2; 0.5, 1, 2, 4, 6 hr postdose on Day 1|PK population. Here, number of participants analyzed = participants who were BRAFi-naïve participants.||mcg/mL||Standard Deviation|Mean
834614|NCT01271803|Primary|Cmax of Vemurafenib on Day 1, Cycle 1 in BRAFi-naïve Participants||Predose (0 hr) on Day 1, 2; 0.5, 1, 2, 4, 6 hr postdose on Day 1|PK population.Here, number of participants analyzed = participants who were BRAFi-naïve participants.||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
834615|NCT01271803|Primary|Tmax of Vemurafenib on Day -1, Cycle 1 in Participants Previously Treated With Vemurafenib Prior to Enrollment Into This Study||Predose (0 hr) on Day -1, 1; 2, 4, 6, 8 hr postdose on Day -1|PK population. Here, number of participants analyzed = participants who were previously treated with vemurafenib prior to enrollment into this study.||hours||Full Range|Median
834616|NCT01271803|Primary|Cmax of Vemurafenib on Day -1, Cycle 1 of Cohorts 1C and 2A in Participants Previously Treated With Vemurafenib Prior to Enrollment Into This Study||Predose (0 hr) on Day -1, 1; 2, 4, 6, 8 hr postdose on Day -1|PK population. Here, number of participants analyzed = participants who were previously treated with vemurafenib prior to enrollment into this study.||mcg/mL||Standard Deviation|Mean
834617|NCT01271803|Primary|Cmax of Vemurafenib on Day -1, Cycle 1 in Participants Previously Treated With Vemurafenib Prior to Enrollment Into This Study||Predose (0 hr) on Days -1, 1; 2, 4, 6, 8 hr postdose on Day -1|PK population. Here, number of participants analyzed = participants who were previously treated with vemurafenib prior to enrollment into this study.||micrograms per milliliter (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
834618|NCT01271803|Primary|Clearance (CL) of Cobimetinib on Day 14 (Steady State), Cycle 1|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.|Cycle 1: predose (0 hr) on Days 8, 14; 0.5, 1, 2, 4, 6 hr postdose on Day 14|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||Liters per hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
834619|NCT01271803|Primary|AUC0-24 of Cobimetinib on Day 14, Cycle 1||Cycle 1: predose (0 hr) on Days 8, 14; 0.5, 1, 2, 4, 6 hr postdose on Day 14|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
834620|NCT01271803|Primary|Tmax of Cobimetinib on Day 14 (Steady State), Cycle 1||Cycle 1: predose (0 hr) on Days 8, 14; 0.5, 1, 2, 4, 6 hr postdose on Day 14|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Median
834621|NCT01271803|Primary|Cmax of Cobimetinib on Day 14 (Steady State), Cycle 1||Cycle 1: predose (0 hr) on Days 8, 14; 0.5, 1, 2, 4, 6 hr postdose on Day 14|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
834622|NCT01271803|Primary|AUC0-24 of Cobimetinib on Day 1, Cycle 1 of Cohort 3||Cycle 1: predose (0 hr) on Days 1, 2; 0.5, 1, 2, 4, 6 hr postdose on Day 1|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng*h/mL||Standard Deviation|Mean
834623|NCT01271803|Primary|Area Under Concentration Versus Time Curve (AUC) Over a Period of 24 Hours (AUC0-24) of Cobimetinib on Day 1, Cycle 1||Cycle 1: predose (0 hr) on Days 1, 2; 0.5, 1, 2, 4, 6 hr postdose on Day 1|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||nanograms*hours per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
834624|NCT01271803|Primary|Time Taken to Reach Maximum Plasma Concentration (Tmax) of Cobimetinib on Day 1, Cycle 1||Cycle 1: predose (0 hr) on Days 1, 2; 0.5, 1, 2, 4, 6 hr postdose on Day 1|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Median
834625|NCT01271803|Primary|Cmax of Cobimetinib on Day 1, Cycle 1 in Cohort 3||Cycle 1: predose (0 hr) on Days 1, 2; 0.5, 1, 2, 4, 6 hr postdose on Day 1|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng/mL||Standard Deviation|Mean
834627|NCT01271803|Primary|Maximum Tolerated Doses (MTD) of Vemurafenib and Cobimetinib When Administered in Combination in DES|The highest dose level(s) at which fewer than one-third of participants experienced a DLT was declared the MTD. DLT is defined as 1 of the following toxicities considered by the investigator to be related to study treatment: a) Grade 3 nausea, vomiting or diarrhea that resolved to Grade ≤1 within 7 days, b) Grade 3 rash/photosensitivity that resolved to Grade ≤2 within 7 days, c) Grade 3 cuSCC that was subsequently resected, d) Grade ≥3 fatigue/hyperuricemia that resolved to Grade ≤2 within 7 days, e) Grade 3 fever, f) Grade 3 or 4 elevation of serum CPK levels, which is asymptomatic, deemed to be clinically insignificant and returns to Grade ≤2 during the 14-day cobimetinib treatment holiday, g) Grade ≥3 febrile neutropenia, h) Grade ≥4 neutropenia (ANC <500/ μL), i) Grade ≥4 thrombocytopenia, j) Grade ≥4 anemia, k) Grade ≥3 elevation of total bilirubin, hepatic transaminase or alkaline phosphatase.|28 Days|Safety-evaluable population. Here, number of participants analyzed = participants who were evaluable for this outcome.||mg|||Number
834628|NCT01271803|Primary|Number of Participants With Dose-Limiting Toxicities (DLTs) During DES in Combination Cohorts|DLT is defined as 1 of the following toxicities considered by the investigator to be related to study treatment: a) Grade 3 nausea, vomiting or diarrhea that resolved to Grade less than or equal to (≤) 1 within 7 days, b) Grade 3 rash or photosensitivity that resolved to Grade ≤2 within 7 days, c) Grade 3 cutaneous squamous cell carcinoma (cuSCC) that was subsequently resected, d) Grade greater than or equal to (≥) 3 fatigue or hyperuricemia that resolved to Grade ≤2 within 7 days, e) Grade 3 fever, f) Grade 3 or 4 elevation of serum creatine phosphokinase (CPK) levels, which is asymptomatic, deemed by the investigator to be clinically insignificant and that returned to Grade ≤2 during the 14-day cobimetinib treatment holiday, g) Grade ≥3 febrile neutropenia, h) Grade ≥4 neutropenia (absolute neutrophil count [ANC] less than <500/microliter [μL]), i) Grade ≥4 thrombocytopenia, j) Grade ≥4 anemia, k) Grade ≥3 elevation of total bilirubin, hepatic transaminase or alkaline phosphatase.|28 Days|Safety-evaluable population (SEP) included all participants who received at least one dose of study drug. SEP participants who received combination study treatment (cobimetinib + Vemurafenib) were included in the analysis of this outcome. Here, number of participants analyzed = participants who were evaluable for this outcome.||participants|||Number
834629|NCT01271907|Secondary|Investigate Low-dose Systemic Aldesleukin to Cell Efficacy|Low-dose systemic aldesleukin will be evaluated to determine cell activity in metastatic melanoma.|7 months|Zero participants were analyzed for this outcome measure. Greater than 10 participants were needed to evaluate this outcome measure. These were not explored in the small number of patients studied.|||||
834630|NCT01271907|Primary|Safety of Drosophila Generated PBL Administered in Combination With a Lymphodepleting Preparative Regimen and Supportive Systemic Aldesleukin|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|7 months|Cohorts 1 and 2 did not enroll participants because the study was terminated due to poor accrual.||Participants|||Count of Participants
834631|NCT01271907|Primary|Clinical Response|Clinical response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete response (CR) is a disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progression disease (PD) is at least a 20 % increase in the sum of the LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.|7 months|Cohorts 1 and 2 did not enroll participants because the study was terminated due to poor accrual.||Participants|||Count of Participants
834632|NCT01271946|Secondary|Time to Ambulation|Time to ambulation for the diagnostic cohort, compared to published literature rates of 4.75 hours for time to ambulation for standard manual compression.|Ambulation was evaluated at any time after 1, 2 and 4 hours post sheath removal, until the subject was successfully ambulated.|Per Protocol-Diagnostic Cohort.||Hours||Standard Deviation|Mean
834633|NCT01271946|Secondary|Time to Hemostasis|Time to hemostasis for the diagnostic cohort, compared to published literature rates of 17 minutes for time to hemostasis for standard manual compression.|Hemostasis was evaluated immediately following procedural sheath removal.|Per protocol-Diagnostic Cohort.||Minutes||Standard Deviation|Mean
834634|NCT01271946|Primary|Percentage of Participants With Bed Elevation Within 15 Minutes.|Successful bed elevation was defined as the ability to sit up at a 45 degree angle within 15 minutes (1-30 minutes window) following sheath removal and successful hemostasis, without re-bleeding. This outcome was evaluated in subjects in whom successful access with the Arstasis device was achieved. The outcome measurement is reported as percentage of subjects.|Post procedure|Per protocol.||Percentage of participants|||Number
834635|NCT01271946|Primary|Time to Ambulation|Time to ambulation was recorded as the difference between the time the procedural sheath is removed from the femoral artery and the time when the subject stands and walks at least 20 feet without re-bleeding.|Ambulation was evaluated at any time after 1, 2 and 4 hours post sheath removal, until the subject was successfully ambulated.|Per protocol.||Hours||Standard Deviation|Mean
834636|NCT01271946|Primary|Time to Actual Discharge|The time from sheath removal to actual hospital discharge.|Actual discharge was evaluated following procedural sheath removal until actual discharge, an average time of 9.3 hours.|Per protocol.||Hours||Standard Deviation|Mean
834637|NCT01271946|Primary|Time to Discharge Eligibility|The time from sheath removal to the time when the subject was medically able to be discharged based solely on the assessment of the access site.|Discharge Eligibility was evaluated following sheath removal and ambulation and physical examination of the access site demonstrating stable access site.|Per Protocol.||Hours||Standard Deviation|Mean
834638|NCT01271946|Primary|Time to Hemostasis|The difference between the time the procedural sheath was removed from the femoral artery and the time when hemostasis was observed.|Hemostasis was evaluated immediately following procedural sheath removal until hemostasis was achieved.|Per protocol.||Minutes||Standard Deviation|Mean
834639|NCT01271946|Primary|Minor Adverse Events|Observation of any minor access site-related complications.|Procedure through 30 day follow-up.|||Percentage of participants|||Number
834640|NCT01271946|Primary|Device Success|Achievement of femoral artery access using the Arstasis Access System followed by placement of the procedural sheath in the femoral artery.|Procedure|Intent to treat.||Percentage of participants|||Number
834643|NCT01272011|Secondary|Ventilatory Loading - Phase 3|Ventilatory load compensation was assessed in two ways. Mean slopes for (1) pressure vs. resistance (P vs R) and (2) airflow vs. resistance (AF vs R) were calculated for pre- and post-IH treatment.|Pre- versus Post-treatment|Data were collected from 3 participants. However, clinical observations revealed results of interest from only 1/3 of the participants. Therefore, data from only this 1 individual were analyzed for presentation as a case study. The data from the other 2 participants were not analyzed.||unitless||Standard Error|Mean
834644|NCT01272011|Primary|Minute Ventilation - Phase 2|Minute ventilation (Ve) is the volume of gas inhaled or exhaled from a person's lungs per minute. Minute ventilation during the end-recovery (ER) period at initial (i.e., Days 1 and 2, initial ER period) and final (i.e., Days 9 and 10, final ER period) days of the IH protocol were normalized to values from baseline with elevated carbon dioxide (B2) within each individual session to characterize daily effects of exposure to IH at the beginning and end of treatment. Values from baseline with elevated carbon dioxide and the ER period during the final days of the protocol (final B2 and final ER period, respectively) also were normalized to elevated carbon dioxide baseline during initial days of the protocol (initial B2) to describe the cumulative effects of repeated exposure to IH. Outcomes are reported as % increases in minute ventilation during initial and final treatment sessions for daily/acute effects and cumulative/chronic effects.|Pre- versus Post-treatment|||percentage of baseline||Standard Error|Mean
834645|NCT01272076|Primary|Difference in mm Squared of Cirrus HD-OCT Automated Measurements of the Illumination Areaa Under the RPE to Expert Manual Measurement of Areas of Hypofluorescence Typical of Geographic Atrophy (GA).|In retinal areas with atrophy, light emitted from the Cirrus penetrates the sclera and choroid which are more reflecting compared with the Retinal Pigment Epithelium (RPE). The areas with higher illumination are associated with areas of Geographic Atrophy (GA), and allow to quantify how big is the area of atrophy. The study will assess the difference between Cirrus HD-OCT measurements of areas of increased illumination under the RPE to hypofluorescence areas on fundus photos as assessed manually by retina specialists.|August 2011|Subjects with dry AMD and Geographic Atrophy. The required sample size was calculated based on previous experience with the device and its variability.||mm^2||Standard Deviation|Mean
834646|NCT01272141|Primary|The Safety and Toxicity of the Combination Therapy of Lapatinib and Everolimus Will be Monitored Using the NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v. 3.0. The Incidence of Any Grade 3 or 4 Toxicities Will be Analyzed.||Safety assessments will be performed every four weeks while the patient remains on study.|No data were collected due to early termination.|||||
834647|NCT01272141|Primary|Overall Response Rate Will Measured Using Response Evaluation Criteria in Solid Tumors (RECIST) Criteria. Tumor Assessment for All Lesions Must be Performed Every Eight Weeks While on Study by CT Scan.||Tumor assessment for all lesions must be performed by CT scan every 8 weeks while on study.|No data were collected due to early termination.|||||
834648|NCT01272180|Primary|Desirability Index for Each Vaccine Group, Based on Immunogenicity and Reactogenicity Parameters.|The overall desirability index (DI) used to identify the optimal formulation of the combination vaccine was based on immunogenicity and reactogenicity parameters (on a scale of 0 to 1, with 0 for an undesirable response and 1 for a highly desirable response) as follows: Between-group ratios of hSBA GMTs were calculated, adjusted for prevaccination titer and center, against serogroups A, C, W, and Y (ABCWY+OMV group or ABCWY+qOMV group vs. Placebo/ACWY group) and against the 4 serogroup B test strains (ABCWY+OMV group or ABCWY+qOMV group vs. rMenB+OMV group). Reactogenicity was measured by the percentage of doses associated with severe local and systemic solicited AEs within 3 days following vaccination. Each immunogenicity and reactogenicity endpoint was assigned its own DI based on predefined desirability functions. The overall DI was calculated using the weighted geometric mean of the DI values of each of the ten parameters to derive an overall DI for each formulation.|One month after the second vaccination (Day 91)|"Analysis was done on the Per Protocol Set - desirability, ie, all subjects who :
correctly received the vaccine at Visit 1 and Visit 2, provided evaluable serum samples pre- (Visit 1) and post-vaccination (Visit 3), provided post-vaccination solicited adverse event data an had no major protocol violation as defined prior to unblinding."||Desirability index|||Number
834649|NCT01272180|Secondary|The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Any Vaccination in This Study.|The number of subjects reporting unsolicited AEs after vaccination with ABCWY+OMV, ABCWY+qOMV, rMenB+OMV or MenACWY.|Throughout the study ( Day 1 to Day 241)|Analysis was done on the unsolicited safety set, ie, all subjects in the all exposed set who provided postvaccination unsolicited AE data.||Participants|||Number
834650|NCT01272180|Secondary|The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study.|The number of subjects reporting solicited local and systemic adverse events and other indicators of reactogenicity after vaccination with ABCWY+OMV, ABCWY+qOMV or rMenB+OMV or MenACWY.|Day 1 through day 7 after any vaccination|Analysis was done on the solicited safety set, ie all subjects in the all exposed set who provided postvaccination solicited AE data from day 1 (6 hours) through day 7. The all exposed set is defined as all subjects in the all enrolled population who actually received a study vaccination.||Participants|||Number
834651|NCT01272180|Secondary|The Geometric Mean Ratio of Post vs Pre Vaccination GMTs Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine.|The geometric mean ratio (GMR) of post vaccination versus pre vaccination GMTs against N.meningitidis serogroup B after two doses of ABCWY+OMV, ABCWY+qOMV or rMenB+OMV vaccine.|One month after the second vaccination/prevaccination (Day 91/day 1)|Analysis was done on the per-protocol population||Ratio||95% Confidence Interval|Geometric Mean
834652|NCT01272180|Secondary|The hSBA GMTs Against N.Meningitidis serogroupB, After Vaccination With Different Formulations of MenABCWY Combination Vaccine.|The hSBA GMTs against N.meningitidis serogroup B after two doses of ABCWY+OMV, ABCWY+qOMV or rMenB+OMV vaccine.|Day 1 and one month after the second vaccination (Day 91)|Analysis was done on the per-protocol population, immunogenicity.||Titers||95% Confidence Interval|Geometric Mean
834653|NCT01272180|Secondary|Percentages of Subjects With at Least 4-fold Increase in hSBA Titers Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine.|"The percentages of subjects with at least 4-fold increase in hSBA titers against four different strains of N.meningitidis serogroup B, after two doses of ABCWY+OMV, ABCWY+qOMV or rMenB+OMV vaccine.
4-fold increase is defined as follows;
for subjects with a prevaccination hSBA < 1:2, a postvaccination hSBA ≥ 1:8, for subjects with a prevaccination hSBA ≥ 1:2, at least a 4-fold increase."|One month after the second vaccination (Day 91)|Analysis was done on the per-protocol population, immunogenicity.||Percentages of subjects||95% Confidence Interval|Number
834654|NCT01272180|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:5 and ≥ 1:8 Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine.|The percentages of subjects with hSBA titers ≥ 1:5 and ≥ 1:8 against four different strains of N.meningitidis serogroup B, after two doses of ABCWY+OMV, ABCWY+qOMV or rMenB+OMV vaccine.|Day 1 and one month after the second vaccination (Day 91)|Analysis was done on the per-protocol population, immunogenicity||Percentages of subjects||95% Confidence Interval|Number
834655|NCT01272180|Secondary|The hSBA GMTs Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine.|The hSBA GMTs against N.meningitidis serogroups A,C,W-135 and Y, after two doses of either ABCWY+OMV or ABCWY+qOMV combination vaccine, or one dose of MenACWY vaccine.|Day 1 and one month after the second vaccination (Day 91)|Analysis was done on the per protocol population, immunogenicity.||Titers||95% Confidence Interval|Geometric Mean
834656|NCT01272180|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:8 Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine.|Percentages of subjects with hSBA titers ≥ 1:8 against N.meningitidis serogroups A,C,W-135 and Y, after two doses of either ABCWY+OMV or ABCWY+qOMV combination vaccine or one dose of MenACWY vaccine.|Day 1 and one month after second vaccination (Day 91)|Analysis was done on the per protocol population, immunogenicity.||Percentages of subjects||95% Confidence Interval|Number
834657|NCT01272180|Primary|Percentages of Subjects With a Seroresponse Against N.Meningitidis Serogroups A,C,W-135,Y, After Receiving Different Formulations of MenABCWY Combination Vaccine.|"Non-inferiority of immune response of two doses of two different formulations of MenABCWY vaccine to a single dose of MenACWY vaccine as measured by the percentage of subjects with hSBA seroresponse against N.meningitidis serogroups A,C,W and Y.
Seroresponse is defined as:
For subjects with a pre-vaccination hSBA titer < 1:4, a post-vaccination hSBA titer ≥ 1:8;
For subjects with a pre-vaccination hSBA titer ≥ 1:4, an increase in hSBA titer of at least four times the prevaccination titer.
Functional bactericidal antibodies directed against serogroups A,C,W,Y meningococci were measured with a serum bactericidal activity assay using human serum as the source of exogenous complement (hSBA)."|One month after the second vaccination (Day 91)|Analysis was done on the per protocol population, immunogenicity, i.e subjects who received correct vaccines in both the visits; provided evaluable serum sample pre and post vaccination with assay results available for at least one serogroup and/or strain and had no major protocol violations.||Percentages of subjects||95% Confidence Interval|Number
834658|NCT01272193|Secondary|Change in Body Weight|Observed change from baseline in body weight after 26 weeks of treatment|Week 0, Week 26|Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator. Missing data is imputed using last observation carried forward (LOCF).||kg||Standard Deviation|Mean
834659|NCT01272193|Secondary|Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Observed rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 a.m.|Week 0 to Week 26 + 7 days follow up|Safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||Episodes/100 years of patient exposure|||Number
834660|NCT01272193|Secondary|Rate of Confirmed Hypoglycaemic Episodes|Observed rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 26 + 7 days follow up|Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.||Episodes/100 years of patient exposure|||Number
834661|NCT01272193|Secondary|Rate of Treatment Emergent Adverse Events (AEs)|Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.|Week 0 to Week 26 + 7 days follow up|Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.||Events/100 years of patient exposure|||Number
834662|NCT01272193|Secondary|Mean Increment of 9-point Self Measured Plasma Glucose Profile (SMPG) at the Main Evening Meal|Observed mean increment of the 9-point self-measured plasma glucose profile (SMPG) at the main evening meal|Week 26|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF).||mmol/L||Standard Deviation|Mean
834663|NCT01272193|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Observed change from baseline in HbA1c after 26 weeks of treatment|Week 0, Week 26|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF).||percentage of glycosylated haemoglobin||Standard Deviation|Mean
834706|NCT01272583|Primary|Glucagon Response to Acute Hypoglycaemia|Change in glucagon concentration from the initialisation phase to 40 minutes after occurrence of the autonomic reaction to hypoglycaemia|Change from initialisation phase to 40 minutes after onset of hypoglycaemia|||pmol/L||Inter-Quartile Range|Median
834707|NCT01272635|Secondary|Drug Related Side Effects|Parent-reported gastrointestinal symptoms during treated RTI.|14 days after initiation of therapy|||events|||Number
834688|NCT01272284|Secondary|"Percentage of Patients Responding Very Much Better or Much Better on PGI-I at 12 Months"|"Success defined as a response of Very Much Better or Much Better at 12 months, as measured by validated Patient Global Impression of Improvement (PGI-I)."|12 months|105 subjects were eligible for 12-month follow-up. 2 subjects either missed the visit or did not complete the PGI-I.||percentage of participants|||Number
834689|NCT01272284|Secondary|Percentage of Participants With at Least 50% Improvement in IIQ-7 From Baseline to 12 Months|Success defined as at least a 50% improvement from baseline to 12 months, as measured by validated Incontinence Impact Questionnaire Short Form (IIQ-7)|12 months (compared to baseline)|105 subjects were eligible for 12-month follow-up. 2 subjects either missed the visit or did not complete the IIQ-7.||percentage of participants|||Number
834690|NCT01272284|Secondary|Percentage of Participants With at Least 50% Improvement in UDI-6 Score From Baseline to 12 Months|Success defined as at least a 50% improvement from baseline to 12 months, as measured by validated Urinary Distress Inventory Short Form (UDI-6)|12 months (compared to baseline)|105 subjects were eligible for 12-month follow-up. 2 subjects either missed the visit or did not complete the UDI-6.||percentage of participants|||Number
834691|NCT01272284|Secondary|Percentage of Participants With Negative Cough Stress Test at 12 Months|"Success defined as a negative result at 12 months, as measured by the Cough Stress Test (CST).
The cough stress test was completed with the subject in the lithotomy and standing positions, filling bladder to maximum capacity with normal saline. The subject was then asked to cough 10 times and any leakage from the urethra was considered a positive test."|12 months (compared to baseline)|105 subjects were eligible for 12-month follow-up. 4 subjects missed either the visit or the cough stress test.||percentage of participants|||Number
834692|NCT01272284|Secondary|Percentage of Participants With at Least 50% Reduction in 24-hour Pad Weight From Baseline to 12 Months|Success defined as at least a 50% reduction in 24-hour pad weight from baseline to 12 months.|12 months (compared to baseline)|105 subjects were eligible for 12-month follow-up. 4 subjects missed either the visit or the pad weight test.||percentage of participants|||Number
834693|NCT01272284|Secondary|"Percentage of Patients Responding Very Much Better or Much Better on PGI-I at 6 Months"|"Success defined as a response of Very Much Better or Much Better at 6 months, as measured by validated Patient Global Impression of Improvement (PGI-I)."|6 months|109 subjects were eligible for 6-month follow-up. 4 subjects either missed the visit or did not complete the PGI-I.||percentage of participants|||Number
834694|NCT01272284|Secondary|Percentage of Participants With at Least 50% Improvement in IIQ-7 From Baseline to 6 Months|Endpoint defined as at least a 50% improvement from baseline to 6 months, as measured by validated Incontinence Impact Questionnaire Short Form (IIQ-7), in which the percent of subjects with at least a 50% improvement from baseline to 6 months is compared to a performance goal of 50%.|6 months (compared to baseline)|109 subjects were eligible for 6-month follow-up. 5 subjects either missed the visit or did not complete the Incontinence Impact Questionnaire.||percentage of participants|||Number
834695|NCT01272284|Secondary|Percentage of Participants With at Least 50% Improvement in UDI-6 Score From Baseline to 6 Months|Endpoint defined as at least a 50% improvement from baseline to 6 months, as measured by validated Urinary Distress Inventory Short Form (UDI-6), in which the percent of subjects with at least a 50% improvement from baseline to 6 months is compared to a performance goal of 50%.|6 months (compared to baseline)|109 subjects were eligible for 6-month follow-up. 4 subjects either missed the visit or did not complete the Urinary Distress Inventory.||percentage of participants|||Number
834696|NCT01272284|Secondary|Percentage of Participants With at Least 50% Improvement in Incontinence Via 3-Day Voiding Diary From Baseline to 6 Months|"Endpoint defined as at least a 50% improvement from baseline to 6-months, as measured by 3-Day Voiding Diary, in which the percent of subjects with at least a 50% improvement from baseline to 6 months is compared to a performance goal of 50%.
Subjects completed a 3-Day Voiding Diary of controlled urinations and the number and amount of leaks experienced."|6 months (compared to baseline)|109 subjects were eligible for 6-month follow-up. 17 subjects either missed the visit or did not complete the 3-Day Voiding Diary.||percentage of participants|||Number
834697|NCT01272284|Secondary|Percentage of Participants With Negative Cough Stress Test at 6 Months|"Endpoint defined as a negative result at 6 months, as measured by the Cough Stress Test (CST), in which the percent of subjects with a negative CST is compared to a performance goal of 66%.
The cough stress test was completed with the subject in the lithotomy and standing positions, filling bladder to maximum capacity with normal saline. The subject was then asked to cough 10 times and any leakage from the urethra was considered a positive test."|6 months|109 subjects were eligible for 6-month follow-up. 6 subjects missed either the visit or the cough stress test.||percentage of participants|||Number
834698|NCT01272284|Primary|Percentage of Participants With at Least 50% Reduction in 24-hour Pad Weight From Baseline to 6 Months|Primary endpoint defined as at least a 50% reduction in 24-hour pad weight from baseline to 6 months (including dry as defined as a pad weight of less than 1.3 grams during the 6-month test), in which the percent of subjects with at least 50% reduction in 24-hour pad weight is compared to a performance goal of 50%.|6 months (compared to baseline)|Analysis was per protocol. 109 subjects were eligible for 6-month follow-up. 6 subjects missed either the visit or the pad weight test.||percentage of participants|||Number
834699|NCT01272583|Secondary|Symptomatic Hormone Responses to Acute Hypoglycaemia.|The symptomatic responses to hypoglycaemia were assessed using a standard validated symptom questionnaire adapted for experimental hypoglycaemia (McCrimmon et al (2003) Diabet.Med. 20: 507-509). A 7-point Likert scale (1=symptom absent; 7=symptom experienced with great intensity) was used to score presence and intensity of autonomic and neuroglycopenic symptoms of hypoglycaemia. Symptom scores were obtained during the initialisation phase, at occurrence of autonomic reaction and again 30 minutes later. For analyses the scale was considered as a continuous variable.|Change from baseline symptomatic response at hypoglycaemia and 30 minutes after hypoglycaemia|||units on a scale||Inter-Quartile Range|Median
834700|NCT01272583|Secondary|Cortisol Response to Acute Hypoglycaemia|Area under the curve (AUC) from onset of the autonomic response to hypoglycaemia to 40 minutes after onset of the autonomic response. AUC values were calculated by the trapezoid method.|0, 10, 20, 40 minutes|||mU*minutes/L||Inter-Quartile Range|Median
834701|NCT01272583|Secondary|Growth Hormone Response to Acute Hypoglycaemia|Area under the curve (AUC) from onset of the autonomic response to hypoglycaemia to 40 minutes after onset of the autonomic response. AUC values were calculated by the trapezoid method.|0, 10, 20, 40 minutes|||mU*minutes/L||Inter-Quartile Range|Median
834702|NCT01272583|Secondary|Norepinephrine Response to Acute Hypoglycaemia|Area under the curve (AUC) from onset of the autonomic response to hypoglycaemia to 40 minutes after onset of the autonomic response. AUC values were calculated by the trapezoid method.|0, 10, 20, 40 minutes|||nmol*minutes/L||Inter-Quartile Range|Median
834703|NCT01272583|Primary|Glucagon Response to Acute Hypoglycaemia|Area under the curve (AUC) from onset of the autonomic response to hypoglycaemia to 40 minutes after onset of the autonomic response. AUC values were calculated by the trapezoid method.|0, 10, 20 and 40 minutes|||pmol*minutes/L||Inter-Quartile Range|Median
834704|NCT01272583|Secondary|Epinephrine Response to Acute Hypoglycaemia|Area under the curve (AUC) from onset of the autonomic response to hypoglycaemia to 40 minutes after onset of the autonomic response. AUC values were calculated by the trapezoid method.|0, 10, 20, 40 minutes|||nmol*minutes/L||Inter-Quartile Range|Median
834705|NCT01272583|Secondary|Intact and Total Glucagon Like Peptide-1 (GLP-1), Intact and Total Gastric Inhibitory Peptide (GIP) Response to Acute Hypoglycaemia|Area under the curve (AUC) from onset of the autonomic response to hypoglycaemia to 40 minutes after onset of the autonomic response. AUC values were calculated by the trapezoid method.|0, 10, 20, 40 minutes|||pmol*minutes/L||Inter-Quartile Range|Median
834710|NCT01272635|Secondary|Asthma Related Symptoms Among RTI Progressing to Severe LRTI|Asthma related symptoms as measured by the parent-completed Pre-school Asthma Symptom Diary (PAD). The PAD was completed daily starting on the first day of an illness and continued until the participant was symptom-free for 2 days. It contains questions of frequency of respiratory symptoms, each scored on a scale of 1 through 7, with higher scores representing increasingly frequent symptoms, with daily scores ranging from 0 (asymptomatic) to a maximum of 102. The total PAD score is the sum of the daily individual symptom scores over the duration of the illness, with higher scores representing more frequent symptoms.|14 days after initiation of therapy|Respiratory Tract Infections (RTI) progressing to Severe Lower RTI||PAD score||Standard Deviation|Mean
834711|NCT01272635|Primary|OCELOT: Pediatric Respiratory Assessment Measure|The Pediatric Respiratory Assessment Measure (PRAM) is a composite outcome with scores ranging from 0-12 with higher numbers representing worse symptoms. The score is calculated as the sum total of the follow five elements: (1) scalene retractions, (2) suprasternal retractions, (3) wheezing, (4) air entry, (5) oxygen saturation. A complete description can be found in: Ducharme FM, Chalut D, Plotnick L, et al. The Pediatric Respiratory Assessment Measure: a valid clinical score for assessing acute asthma severity from toddlers to teenagers. J Pediatr 2008;152:476-80.|36-72 hours after initiation of OCELOT therapy|Participants who developed severe lower respiratory tract infections and initiate blinded OCELOT therapy.||PRAM score||Standard Deviation|Mean
834712|NCT01272635|Primary|Progression to Clinically Significant Lower Respiratory Tract Symptoms|Progression to clinically significant lower respiratory tract symptoms defined by: (1) having symptoms that were more than mild after 3 albuterol administrations over 1 hour, or (2) requiring albuterol administrations more often than once every 4 hours, or (3) requiring more than 6 albuterol treatments over a 24-hour period, or (4) having moderate to severe cough or wheeze for 5 or more days since study medication was initiated.|14 days after initiation of APRIL therapy|All participants who initiated APRIL therapy||participants|||Number
834713|NCT01272661|Secondary|Breastfeeding Rate at 6 Months Postpartum|Measure breastfeeding rate (any and exclusive) at 6 months postpartum. Rate of any breastfeeding is presented.|Any and exclusive breastfeeding at 6 months, between 22-26 weeks postpartum|ITT analysis conducted on participants with available data||participants|||Number
834714|NCT01272661|Secondary|Breastfeeding Rate at 3 Months Postpartum|Measure rates of any and exclusive breastfeeding at 3 months postpartum. Rate of any breastfeeding is presented.|Any and exclusive breastfeeding at 3 months, between 10-14 weeks postpartum|ITT analysis conducted on participants with available data||participants|||Number
834715|NCT01272661|Secondary|Breastfeeding Rate at One Month Postpartum|Measure rate of breastfeeding (rate of any breastfeeding is main measure, also measure rate of exclusive breastfeeding) at one month postpartum. Will compare rate of any breastfeeding one month postpartum to historical data, and will compare rates of any breastfeeding at one month postpartum between intervention groups.|Any and exclusive breastfeeding at one month, between 21-38 days postpartum|ITT analysis conducted on participants with available data||participants|||Number
834716|NCT01272661|Secondary|Breastfeeding Rate|Measure rate of any breastfeeding (breastfeeding initiation) in the hospital. We will also compare this rate between the 3 intervention groups.|Any breastfeeding: participants were followed for the duration of hospital stay, an average of 48 hours|ITT analysis was conducted on participants with available data||participants|||Number
834717|NCT01272661|Primary|Program Feasibility - Curriculum Modules|Measure program feasibility by counting the number of Breastfeeding Curricular modules that were presented of total possible = 11|by 24 months from program start|||modules presented||Inter-Quartile Range|Mean
834718|NCT01272661|Primary|Program Feasibility- Feeding Outcome Collected|Measure program feasibility by number of participants who were exposed to the intervention for whom there is any feeding outcome|by 24 months|Total number of eligible MomsFirst participants who agreed to data sharing. Outcome shows number w/ any feeding outcome (not lost to follow up, no live birth, case closed by MomsFirst). This is for a 24 month period since all data was de-identified and stripped of dates so unable to specify for 12 month period||participants|||Number
834719|NCT01272804|Secondary|Change From Baseline in Lactate Level at Day 6 and 14|Baseline value was collected at 0 hour on Day 1 for lactate.|Baseline (Day 1), Day 6 and 14|PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter. Here 'n' signifies participants evaluable for this measure at specified time point for each arm group, respectively.||mg/dL||Standard Deviation|Mean
834720|NCT01272804|Secondary|Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up|Blood sample for lipid biomarker was taken following 12-hours fasting. Baseline value was collected on Day -2 for lipids.|Baseline (Day -2), Day 3, 6, 10, 14, 16 and Follow-up (7 to 14 days after last dose of study medication)|PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter. Here 'n' signifies participants evaluable for this measure at specified time point for each arm group, respectively.||mg/dL||Standard Deviation|Mean
834721|NCT01272804|Secondary|Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up|Blood sample for lipid biomarker was taken following 12-hours fasting. Baseline value was collected on Day -2 for lipids.|Baseline (Day -2), Day 3, 6, 10, 14, 16 and Follow-up (7 to 14 days after last dose of study medication)|PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter. Here 'n' signifies participants evaluable for this measure at specified time point for each arm group, respectively.||mg/dL||Standard Deviation|Mean
834722|NCT01272804|Secondary|Change From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-up|Blood sample for lipid biomarker was taken following 12-hours fasting. Baseline value was collected on Day -2 for lipids.|Baseline (Day -2), Day 3, 6, 10, 14, 16 and Follow-up (7 to 14 days after last dose of study medication)|PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter. Here 'n' signifies participants evaluable for this measure at specified time point for each arm group, respectively.||mg/dL||Standard Deviation|Mean
834840|NCT01280552|Secondary|PFS|"Secondary Endpoints
PFS is defined as the time from randomization until the date of documented progressive disease (PD) or death, whichever occurs first, or last date known alive and progression free if progression or death is not observed.
Population is all randomized patients ITT."|2-3 years|Intent to treat includes all randomized patients||months of progression free survival||95% Confidence Interval|Median
834723|NCT01272804|Secondary|Change From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-up|Blood sample for lipid biomarker was taken following 12-hours fasting. Baseline value was collected on Day -2 for lipids.|Baseline (Day -2), Day 3, 6, 10, 14, 16 and Follow-up (7 to 14 days after last dose of study medication)|PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter. Here 'n' signifies participants evaluable for this measure at specified time point for each arm group, respectively.||mg/dL||Standard Deviation|Mean
834724|NCT01272804|Secondary|Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15||Baseline (Pre-dose on Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15|PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter. Here 'n' signifies participants evaluable for this measure at specified time point for each arm group, respectively.||mg/dL||Standard Deviation|Mean
834725|NCT01272804|Secondary|Change From Baseline in Average Plasma Glucose at Day 1, 6, 14|Glucometer testing performed by finger-stick at 8 time points per day to measure glucose levels. Average plasma glucose was calculated as area under the plasma glucose concentration-time curve from 0 to 24 hours (AUC [0-24]) divided by 24.|-46, -44, -42, -40, -38, -36, -30, -27 hrs pre-dose on Day -1; 2, 6, 8, 10, 12,18,21 hrs post-dose on Day 1, 6 and 14; additional 0 hr (pre-dose) on Day 6 and 4 hr post-dose on Day 1 and 14|PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter. Here 'n' signifies participants evaluable for this measure at specified time point for each arm group, respectively.||mg/dL||Standard Deviation|Mean
834726|NCT01272804|Secondary|Percent Change From Baseline in C-peptide Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 and 14|Percent change from baseline in area under the plasma C-peptide concentration-time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. Baseline value was the AUC (2-6) calculated on Day -1.|-46, -45.75, -45.5, -45, -44.5, -44, -43, -42 hrs pre-dose on Day -1; 2, 2.25, 2.5, 3, 3.5, 4, 5, 6 hrs post-dose on Day 1 and 14 (fasted condition)|PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter. Here 'n' signifies participants evaluable for this measure at specified time point for each arm group, respectively.||percent change||Standard Deviation|Mean
834727|NCT01272804|Secondary|Percent Change From Baseline in Insulin Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 and 14|Percent change from baseline in area under the plasma insulin concentration-time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. Baseline value was the AUC (2-6) calculated on Day -1.|-46, -45.75, -45.5, -45, -44.5, -44, -43, -42 hrs pre-dose on Day -1; 2, 2.25, 2.5, 3, 3.5, 4, 5, 6 hrs post-dose on Day 1 and 14 (fasted condition)|PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter. Here 'n' signifies participants evaluable for this measure at specified time point for each arm group, respectively.||percent change||Standard Deviation|Mean
834728|NCT01272804|Primary|Percent Change From Baseline in Glucose Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 14|Percent change from baseline in area under the plasma glucose concentration-time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. Baseline value was the AUC (2-6) calculated on Day -1.|-46, -45.75, -45.5, -45, -44.5, -44, -43, -42 hrs pre-dose on Day -1; 2, 2.25, 2.5, 3, 3.5, 4, 5, 6 hrs post-dose on Day 14 (fasted condition)|PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.||percent change||Standard Deviation|Mean
834729|NCT01272804|Primary|Percent Change From Baseline in Glucose Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1|Percent change from baseline in area under the plasma glucose concentration-time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. Baseline value was the AUC (2-6) calculated on Day -1.|-46, -45.75, -45.5, -45, -44.5, -44, -43, -42 hrs pre-dose on Day -1; 2, 2.25, 2.5, 3, 3.5, 4, 5, 6 hrs post-dose on Day 1 (fasted condition)|Pharmacodynamic (PD) analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter.||percent change||Standard Deviation|Mean
834730|NCT01272804|Primary|Observed Accumulation Ratio for Cmax (Rac, Cmax)|Accumulation ratio for Cmax (Rac, Cmax) was calculated as maximum observed plasma concentration (Cmax) on Day 14 divided by maximum observed plasma concentration (Cmax) on Day 1.|0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 1 and Day 14 (fasted condition)|PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.||ratio||Geometric Coefficient of Variation|Geometric Mean
834731|NCT01272804|Primary|Observed Accumulation Ratio for AUCtau (Rac)|Accumulation ratio for AUCtau (Rac) was calculated as area under the curve from time zero to end of dosing interval (AUCtau) on Day 14 divided by area under the curve from time zero to end of dosing interval (AUCtau) on Day 1. Dosing interval = 24 hours.|0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 1 and Day 14 (fasted condition)|PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.||ratio||Geometric Coefficient of Variation|Geometric Mean
834732|NCT01272804|Primary|Apparent Volume of Distribution (Vz/F) on Day 14|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.|0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 14 (fasted condition)|PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.||liter||Geometric Coefficient of Variation|Geometric Mean
834842|NCT01280591|Secondary|Global Assessment of Investigational Product as a Pain Reliever|The Global Assessment of Investigational Product as a Pain Reliever was a 5- point categorical scale which included the following possible responses: poor (0); fair (1); good (2); very good (3); excellent (4).|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)||Participants|||Number
834733|NCT01272804|Primary|Apparent Oral Clearance (CL/F) on Day 14|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 14 (fasted condition)|PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.||liter per hour||Geometric Coefficient of Variation|Geometric Mean
834734|NCT01272804|Primary|Percentage of Unchanged Drug Excreted in the Urine Over Dosing Interval (Ae[%]) on Day 14|Percentage of drug excreted unchanged in urine calculated as overall amount of unchanged drug excreted in the urine over the dosing interval (24 hours) divided by total daily dose multiplied by 100.|0 hour (pre-dose) through 24 hours post-dose on Day 14|PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.||percentage of dose||Standard Deviation|Mean
834735|NCT01272804|Primary|Minimum Observed Plasma Trough Concentration at Steady State (Cmin, ss) on Day 14||0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16 hours post morning dose on Day 14 (fasted condition)|PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
834736|NCT01272804|Primary|Plasma Decay Half-Life (t1/2) on Day 14|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24, 36, 48 hours post morning dose on Day 14 (fasted condition)|PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.||hour||Standard Deviation|Mean
834737|NCT01272804|Primary|Area Under the Curve From Time Zero to End of Dosing Interval at Steady State (AUCtau, ss) on Day 14|AUCtau, ss = Area under the plasma concentration versus time curve from time zero (pre-dose) to the end of the dosing interval (tau) at steady state, here dosing interval is 24 hours.|0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 14 (fasted condition)|PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.||nanogram*hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
834738|NCT01272804|Primary|Time to Reach Maximum Observed Plasma Concentration at Steady State (Tmax, ss) on Day 14||0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 14 (fasted condition)|PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.||hour||Full Range|Median
834739|NCT01272804|Primary|Maximum Observed Plasma Concentration at Steady State (Cmax, ss) On Day 14||0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 14 (fasted condition)|PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
834740|NCT01272804|Primary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) on Day 1|AUCtau is the area under the plasma concentration versus time curve from time zero (pre-dose) to the end of the dosing interval (tau), here dosing interval is 24 hours.|0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 1 (fasted condition)|PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest.||nanogram*hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
834741|NCT01272804|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 6||0 (pre-dose), 0.5, 1.5, 3, 5, 8 hours post-dose on Day 6 (fed condition)|PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here ‘N' (number of participants analyzed) signifies participants evaluable for this measure.||hour||Full Range|Median
834742|NCT01272804|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 1||0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 1 (fasted condition)|PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest.||hour||Full Range|Median
834743|NCT01272804|Primary|Maximum Observed Plasma Concentration (Cmax) On Day 6||0 (pre-dose), 0.5, 1.5, 3, 5, 8 hours post-dose on Day 6 (fed condition)|PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
834744|NCT01272804|Primary|Maximum Observed Plasma Concentration (Cmax) On Day 1||0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours (hrs) post morning dose on Day 1 (fasted condition)|Pharmacokinetic (PK) parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest.||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
834745|NCT01272804|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 14 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.|Baseline (Day 1) up to 14 days after last dose of study treatment (up to 28 days)|Safety analysis set included all participants who received at least 1 dose of study medication.||participants|||Number
834841|NCT01280552|Primary|Overall Survival (OS)|The objective is to compare overall survival (OS) in patients when treated with ICT 107 versus Control. OS defined as the time from randomization until date of death or the last date patient known alive (if death is not observed) All randomized patients are included in Intent to Treat analysis|2 -3 years|Intent to treat include all randomized patients||months of survival||95% Confidence Interval|Median
834746|NCT01272869|Primary|Frequency of Ballooning in the Morfeus and the Sensura Filter Test Period.|Data will not be recorded at specific time points due to individual changing patterns (1-2 bags per day). Study subjects will fill out the Case Report Form (CRF) by themselves when changing bag. The subject is asked in the CRF among others the reason for changing bag (e.g. ballooning). Subjects will change bag according to their normal routine or when deemed appropriate. They are advised to change bag if it is filled with air and the air cannot be released through the filter within a specified time period.|Daily or at every change of bag in a period of a maximum of 28 days|Intention to treat (ITT)||percentage bags with ballooning|Participants||Number
834747|NCT01272882|Primary|Feasibility of EIT Monitoring in This Population of ARDS/ALI Patients|Feasibility for the purposes of our study was the ability to apply the device to a diverse population of ARDS/ALI patients and obtain EIT data from the device.|At the start of monitoring once the patient was consented and enrolled.|||Patients successfully monitored with EIT|||Number
834748|NCT01272908|Secondary|Change From Baseline in FACIT-F Total Score During the Re-Treatment Period|Participant fatigue was evaluated using the FACIT-F scale, a 13-item questionnaire in which the participants were requested to score each item on a 5-point scale. The FACIT-F scores ranged from 0 to 52, with higher scores representing less fatigue. Score changes of 4 points or more were considered clinically meaningful. The total score was a summation of all 13 items, where 2 of the positive items (I have energy; I am able to do my usual activities) were reversed for scoring.|Weeks 12 and 24 of Re-treatment period|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||scores on a scale||Standard Deviation|Mean
834749|NCT01272908|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Total Score During the Initial Treatment Period|Participant fatigue was evaluated using the FACIT-F scale, a 13-item questionnaire in which the participants were requested to score each item on a 5-point scale. The FACIT-F scores ranged from 0 to 52, with higher scores representing less fatigue. Score changes of 4 points or more were considered clinically meaningful. The total score was a summation of all 13 items, where 2 of the positive items (I have energy; I am able to do my usual activities) were reversed for scoring.|Weeks 4, 12, 24, 36, and 48 of Initial treatment period|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||scores on a scale||Standard Deviation|Mean
834750|NCT01272908|Secondary|Percentage of Participants With Disease Remission According to DAS28 in the Re-Treatment Period|The DAS28 scoring used 4 core components: SJC, TJC, Patient’s Global Assessment of Disease Activity, and ESR. The DAS28 has a continuous scale ranging from 0 to 9.4. The level of disease activity was interpreted as low (DAS28 score ≤3.2), moderate (DAS28 score >3.2 but ≤5.1), or high (DAS28 score >5.1). A DAS28 score ≤2.6 corresponded to a state of remission according to American Rheumatism Association criteria.|Weeks 12 and 24 of Re-treatment period|ITT Population||percentage of participants|||Number
834751|NCT01272908|Secondary|Percentage of Participants With Disease Remission According to DAS28 in the Initial Treatment Period|The DAS28 scoring used 4 core components: SJC, TJC, Patient’s Global Assessment of Disease Activity, and ESR. The DAS28 has a continuous scale ranging from 0 to 9.4. The level of disease activity was interpreted as low (DAS28 score ≤3.2), moderate (DAS28 score >3.2 but ≤5.1), or high (DAS28 score >5.1). A DAS28 score ≤2.6 corresponded to a state of remission according to American Rheumatism Association criteria.|Weeks 4, 12, 24, 36, and 48 of Initial treatment period|ITT Population||percentage of participants|||Number
834752|NCT01272908|Secondary|Change From Baseline CRP During the Re-Treatment Period|CRP levels were measured in mg/L and were used to determine the acute phase response. A reduction in CRP levels is considered an improvement; normal reference range ≤10 mg/L.|Weeks 12 and 24 of Re-treatment period|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||mg/L||Standard Deviation|Mean
834753|NCT01272908|Secondary|Change From Baseline in CRP During the Initial Treatment Period|CRP levels were measured in milligrams/liter (mg/L) and were used to determine the acute phase response. A reduction in CRP levels is considered an improvement; normal reference range ≤10 mg/L.|Weeks 4, 12, 24, 36, and 48 of Initial treatment period|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||mg/L||Standard Deviation|Mean
834754|NCT01272908|Secondary|Change From Baseline in ESR During the Re-Treatment Period|ESR was measured in mm/hour and was used to determine the acute phase response. Lower ESR values indicate reduction in disease activity; normal reference range: 0-20 mm/hr.|Weeks 12 and 24 of Re-treatment period|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||mm/hr||Standard Deviation|Mean
834755|NCT01272908|Secondary|Change From Baseline in ESR During the Initial Treatment Period|ESR was measured in mm/hour and was used to determine the acute phase response. Lower ESR values indicate reduction in disease activity; normal reference range: 0-20 mm/hr.|Weeks 4, 12, 24, 36, and 48 of Initial treatment period|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||mm/hr||Standard Deviation|Mean
834756|NCT01272908|Secondary|Change From Baseline HAQ-DI Score During the Re-Treatment Period|HAQ-DI: 20 questions, 8 categories of functioning: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common usual activities. Participants report amount of difficulty in performing 2-3 specific subcategory items. Difficulty score is from 0 to 3 (0 = without any difficulty; 1 = with some difficulty; 2 = with much difficulty; and 3 = unable to do). The highest component score in each of the 8 categories determines the score for that category, unless aids, devices, and/or help from another person were required which = a score of 2 (unless already 2 or 3). The 8 category scores were averaged into overall HAQ-DI score ranging from 0 to 3 (0 to 1 = mild to moderate difficulty; 1 to 2 = moderate to severe disability; and 2 to 3 = severe to very severe disability). HAQ-DI not computed if >2 categories were missing.|Weeks 12 and 24 of Re-treatment period|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||scores on a scale||Standard Deviation|Mean
834784|NCT01273038|Primary|Frequency of Ballooning in the Morfeus and SenSura Test Period.|Data will not be recorded at specific time points due to individual changing patterns (1-3 bags per day). Study subjects will fill out the Case Report Form (CRF) by themselves when changing bag. The subject is asked in the CRF among others the reason for changing bag (e.g. ballooning). Subjects will change bag according to their normal routine or when deemed appropriate. They are advised to change bag if it is filled with air and the air cannot be released through the filter within a specified time period.|Daily or at every change of bag in a period of a maximum of 28 days|ITT||percentage of bags|Participants||Number
834757|NCT01272908|Secondary|Change From Baseline HAQ-DI Score During the Initial Treatment Period|HAQ-DI: 20 questions, 8 categories of functioning: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common usual activities. Participants report amount of difficulty in performing 2-3 specific subcategory items. Difficulty score is from 0 to 3 (0 = without any difficulty; 1 = with some difficulty; 2 = with much difficulty; and 3 = unable to do). The highest component score in each of the 8 categories determined the score for that category, unless aids, devices, and/or help from another person were required which = a score of 2 (unless already 2 or 3). The 8 category scores were averaged into overall HAQ-DI score ranging from 0 to 3 (0 to 1 = mild to moderate difficulty; 1 to 2 = moderate to severe disability; and 2 to 3 = severe to very severe disability). HAQ-DI not computed if > 2 categories were missing.|Weeks 4, 12, 24, 36, and 48 of Initial treatment period|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||scores on a scale||Standard Deviation|Mean
834758|NCT01272908|Secondary|Change From Baseline in Patient Global Assessment of Pain During the Re-Treatment Period|Patient Global Assessment of Pain was measured using a 100-mm VAS where the extreme left end of the line was 0 = no pain and the extreme right end of the line was 100 = unbearable pain. The participant was asked to mark the line and the distance from the left edge was measured in mm.|Weeks 12 and 24 of Re-treatment period|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||mm||Standard Deviation|Mean
834759|NCT01272908|Secondary|Change From Baseline in Patient Global Assessment of Pain During the Initial Treatment Period|Patient Global Assessment of Pain was measured using a 100-mm VAS where the extreme left end of the line was 0 = no pain and the extreme right end of the line was 100 = unbearable pain. The participant was asked to mark the line and the distance from the left edge was measured in mm.|Weeks 4, 12, 24, 36, and 48 of Initial treatment period|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||mm||Standard Deviation|Mean
834760|NCT01272908|Secondary|Change From Baseline in Patient Global Assessment of Disease Activity During the Re-Treatment Period|Patient Global Assessment of Disease Activity was measured using a 100-mm VAS where the extreme left end of the line was 0 = no disease activity and the extreme right end of the line was 100 = maximum disease activity. The participant was asked to marked the line and the distance from the left edge was measured in mm.|Weeks 12 and 24 of Re-treatment period and Week 4 after last maintenance|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||mm||Standard Deviation|Mean
834761|NCT01272908|Secondary|Change From Baseline in Patient Global Assessment of Disease Activity Score During the Initial Treatment Period|Patient Global Assessment of Disease Activity was measured using a 100-mm VAS where the extreme left end of the line was 0 = no disease activity and the extreme right end of the line was 100 = maximum disease activity. The participant was asked to marked the line and the distance from the left edge was measured in mm.|Weeks 4, 12, 24, 36, and 48 of Initial treatment period|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||mm||Standard Deviation|Mean
834762|NCT01272908|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity During the Re-Treatment Period|Physician Global Assessment of Disease Activity was measured using a 100-mm VAS where the extreme left end of the line was 0 = no disease activity and the extreme right end of the line was 100 = maximum disease activity. The physician marked the line and the distance from the left edge was measured in mm.|Weeks 12 and 24 of Re-treatment period|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||mm||Standard Deviation|Mean
834763|NCT01272908|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity During the Initial Treatment Period|Physician Global Assessment of Disease Activity was measured using a 100-mm visual analog scale (VAS) where the extreme left end of the line was 0 = no disease activity and the extreme right end of the line was 100 = maximum disease activity. The physician marked the line and the distance from the left edge was measured in mm.|Weeks 4, 12, 24, 36, and 48 of Initial treatment period|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||mm||Standard Deviation|Mean
834764|NCT01272908|Secondary|Change From Baseline in TJC During the Re-Treatment Period|Joints assessed for swelling consisted of shoulders, elbows, wrists, interphalangeal (digit 1), distal interphalangeal joints (digits 2-5), proximal interphalangeal joints (digits 2-5), metacarpophalangeal joints (digits 1-5), and knees.|Weeks 12 and 24 of Re-treatment period|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||tender joints||Standard Deviation|Mean
834765|NCT01272908|Secondary|Change From Baseline in TJC During the Initial Treatment Period|Joints assessed for swelling consisted of shoulders, elbows, wrists, interphalangeal (digit 1), distal interphalangeal joints (digits 2-5), proximal interphalangeal joints (digits 2-5), metacarpophalangeal joints (digits 1-5), and knees.|Weeks 4, 12, 24, 36, and 48 of Initial treatment period|ITT Population; n=number of participants assessed for the specific parameter at a given visit.||tender joints||Standard Deviation|Mean
834766|NCT01272908|Secondary|Change From Baseline in SJC During the Re-Treatment Period|Joints assessed for swelling consisted of shoulders, elbows, wrists, interphalangeal (digit 1), distal interphalangeal joints (digits 2-5), proximal interphalangeal joints (digits 2-5), metacarpophalangeal joints (digits 1-5), and knees.|Weeks 12 and 24 of Re-treatment period|ITT Population; n=number of participants assessed for the specified parameter at a given vist.||swollen joints||Standard Deviation|Mean
834767|NCT01272908|Secondary|Change From Baseline in SJC During the Initial Treatment Period|Joints assessed for swelling consisted of shoulders, elbows, wrists, interphalangeal (digit 1), distal interphalangeal joints (digits 2-5), proximal interphalangeal joints (digits 2-5), metacarpophalangeal joints (digits 1-5), and knees.|Weeks 4, 12, 24, 36, and 48 of Initial treatment period|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||swollen joints||Standard Deviation|Mean
834768|NCT01272908|Secondary|Change From Baseline in DAS28 During the Re-Treatment Period|The DAS28 scoring used 4 core components: SJC, TJC, Patient Global Assessment of Disease Activity, and ESR. The DAS28 has a continuous scale ranging from 0 to 9.4. The level of disease activity was interpreted as low (DAS28 score ≤3.2), moderate (DAS28 score >3.2 but ≤5.1), or high (DAS28 score >5.1). A DAS28 score <2.6 corresponded to a state of remission according to American Rheumatism Association criteria. A change of 1.2 units in DAS28 in an individual participant was considered a significant change.|Weeks 12 and 24 of Re-treatment period|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||scores on a scale||Standard Deviation|Mean
834769|NCT01272908|Secondary|Change From Baseline in DAS28 During the Initial Treatment Period|The DAS28 scoring used 4 core components: SJC, TJC, Patient’s Global Assessment of Disease Activity, and ESR. The DAS28 has a continuous scale ranging from 0 to 9.4. The level of disease activity was interpreted as low (DAS28 score ≤3.2), moderate (DAS28 score >3.2 but ≤5.1), or high (DAS28 score >5.1). A DAS28 score <2.6 corresponded to a state of remission according to American Rheumatism Association criteria. A change of 1.2 units in DAS28 in an individual participant was considered a significant change.|Weeks 4, 12, 24, 36, and 48 of Initial treatment period|ITT Population; n (number) = number of participants assessed for the specified parameter at a given visit.||scores on a scale||Standard Deviation|Mean
834770|NCT01272908|Secondary|Percentage of Participants Meeting EULAR Response Criteria During the Re-Treatment Period|The EULAR response criteria were based on the assessment of disease activity using the DAS28. The EULAR response criteria included not only change in disease activity but current disease activity. To be classified as responders, participants had to have a significant change in DAS28 and a low current disease activity. There were 4 categories of EULAR response rates: good, moderate, good/moderate, and none. The DAS28 scoring used 4 core components: SJC, TJC, Patient’s Global Assessment of Disease Activity, and ESR. The DAS28 has a continuous scale ranging from 0 to 9.4. The level of disease activity was interpreted as low (DAS28 score ≤3.2), moderate (DAS28 score >3.2 but ≤5.1), or high (DAS28 score >5.1). A DAS28 score <2.6 corresponded to a state of remission according to American Rheumatism Association criteria.|Weeks 12 and 24 of Re-treatment period|ITT Population||percentage of participants|||Number
834771|NCT01272908|Secondary|Percentage of Participants Meeting European League Against Rheumatism (EULAR) Response Criteria During the Initial Treatment Period|The EULAR response criteria were based on the assessment of disease activity using the DAS28. The EULAR response criteria included not only change in disease activity but current disease activity. To be classified as responders, participants had to have a significant change in DAS28 and a low current disease activity. There were 4 categories of EULAR response rates: good, moderate, good/moderate, and none. The DAS28 scoring used 4 core components: SJC, TJC, Patient’s Global Assessment of Disease Activity, and ESR. The DAS28 has a continuous scale ranging from 0 to 9.4. The level of disease activity was interpreted as low (DAS28 score less than or equal to [≤]3.2), moderate (DAS28 score greater than [>]3.2 but ≤5.1), or high (DAS28 score >5.1). A DAS28 score <2.6 corresponded to a state of remission according to American Rheumatism Association criteria.|Weeks 4, 12, 24, 36, and 48 of Initial treatment period|ITT Population||percentage of participants|||Number
834772|NCT01272908|Secondary|Percentage of Participants With Complete Clinical Response Per ACR Criteria During the Re-Treatment Period|Complete clinical response was defined as having an ACR70 for at least 13 weeks.|Weeks 12 and 24 of Re-treatment period|ITT Population||percentage of participants|||Number
834773|NCT01272908|Secondary|Percentage of Participants Meeting ACR Response Criteria During the Re-treatment Period|ACR20/50/70, defined as ≥20%, 50%, or 70% improvement, respectively, compared to baseline in TJC and SJC, and 20%/50%/70% improvement in at least 3 of 5 additional ACR core set variables: Patient Assessment of Pain; Patient's Global Assessment of Disease Activity; Physician's Global Assessment of Disease Activity; HAQ-DI; and an acute phase reactant (ESR or CRP). If CRP was missing or not done, then ESR was used.|Weeks 12 and 24 of Re-treatment period|ITT Population||percentage of participants|||Number
834774|NCT01272908|Secondary|Percentage of Participants With Complete Clinical Response Per ACR Criteria During the Initial Treatment Period|Complete clinical response was defined as having an ACR70 for at least 13 weeks.|Weeks 4, 12, 24, 36, and 48 of Initial treatment period|ITT Population||percentage of participants|||Number
834775|NCT01272908|Secondary|Percentage of Participants Meeting American College of Rheumatology (ACR) Response Criteria During the Initial Treatment Period|ACR20/50/70, defined as ≥20 percent (%), 50%, or 70% improvement, respectively, compared to baseline in tender joint count (TJC) and swollen joint count (SJC), and 20%/50%/70% improvement in at least 3 of 5 additional ACR core set variables: Patient Assessment of Pain; Patient's Global Assessment of Disease Activity; Physician's Global Assessment of Disease Activity; Health Assessment Questionnaire - Disability Index (HAQ-DI); and an acute phase reactant (erythrocyte sedimentation rate [ESR] or C-Reactive Protein [CRP]). If CRP was missing or not done, then ESR was used.|Weeks 4, 12, 24, 36, and 48 of Initial treatment period|ITT Population||percentage of participants|||Number
834776|NCT01272908|Secondary|Percentage of Participants With Adverse Events During the Re-Treatment Period - Overall Summary|Percentage of participants who reported an AE or SAE, a drug-related AE, who had an acute infusion reaction, an AE leading to study drug discontinuation, with an infection or serious infection, or who died.|Days 1, 2, 15, and 16 and Week 48 of Re-treatment period|ITT Population||percentage of participants|||Number
834777|NCT01272908|Primary|Percentage of Participants With Adverse Events During the Initial Treatment Period - Overall Summary|Percentage of participants who reported an AE or serious AE (SAE), a drug-related AE, who had an acute infusion reaction, an AE leading to study drug discontinuation, with an infection or serious infection, or who died.|Days 1, 2, 15, and 16 and Week 48 of Initial treatment period|ITT Population||percentage of participants|||Number
834778|NCT01272921|Primary|Duration of Motor and Sensory Block of the Sciatic With 0.5% Bupivacaine and Ropivacaine After Ultrasound-guided Nerve-stimulator–Assisted Needle Positioning Beneath the CIEL|Subject reported and investigator measured motor and sensory blockade of the sciatic nerve with less than 10ml of 0.5% bupivacaine and ropivacaine after ultrasound-guided nerve-stimulator–assisted needle positioning beneath the common investing external layer (CIEL).|3 days|||Hours||95% Confidence Interval|Median
834779|NCT01272921|Secondary|Cumulative Probabilities for Needle Positioning Above and Below CIEL.|The cumulative probability distributions for the minimal current to evoke a motor response with the needle tip positioned external (above) to the common investing extraneural layer (CIEL) and the cumulative probability distribution for the needle tip postioned internal (below) to the CIEL were sought. The difference in the mean minimum threshold current (mA) for the external (above) and internal (below) CIEL positioning were calculated.|1 Day|||Amplitude (mA)||95% Confidence Interval|Mean
834780|NCT01272934|Secondary|Onset of Pain Relief|Onset of perceptible pain relief.|On day 1|||Hours||Inter-Quartile Range|Median
834781|NCT01272934|Primary|Pain on Movement|"Pain on Movement at 72 hours assessed on a 100 mm visual analog scale with anchors at 0=No pain and 100= Extreme pain"|72 hours|||mm||Standard Deviation|Mean
834782|NCT01272947|Secondary|Onset of Pain Relief|Onset of perceptible pain relief.|From randomization to end of day 1|||Hours||Inter-Quartile Range|Median
834785|NCT01273064|Secondary|Greater Than 2 Log Decline in HCV-RNA at Study Weeks 12, 24 and 48|"Percent of patients experiencing a drop in Hepatitis C virus ribonucleic acid (HCV-RNA, also known as viral load) levels in the blood equal to, or greater than, 2 log from before treatment (baseline) through 12, 24, and 48 weeks of treatment."|Baseline, and Study Weeks 12, 24, and 48|Due to the premature discontinuation of this study and termination of the entire CTS-1027 program, an efficacy analysis was not conducted. No patients completed the study.||Percent of participants|||Number
834786|NCT01273064|Primary|Sustained Virologic Response|Percent of patients that achieve a sustained virologic response (SVR) at Week 72 defined as HCV-RNA (Hepatitis C virus ribonucleic acid, also known as 'viral load') level below the quantification limit (BQL) at Week 72.|Baseline and 24 weeks after the end of treatment (Week 72)|Due to the premature discontinuation of this study and termination of the entire CTS-1027 program, an efficacy analysis was not conducted. No patients completed the study.||Percent of participants|||Number
834787|NCT01273181|Primary|Clinical Tumor Regression (Complete Response (CR) + Partial Response (PR)) in Patients With Metastatic Cancer|Tumor regression response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is a disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.|2 years|||Participants|||Number
834788|NCT01273181|Primary|Toxicity Profile|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|2 years|||Participants|||Number
834789|NCT01273519|Primary|Participant Assessment of the Presence of Distress Caused by Pain in the Last 3 Months Recorded on a Likert Scale at Baseline and Month 12|Participants indicated their perception of average distress caused by pain in the past 3 months on a 5-point Likert scale, where; 0 = no pain, 1 = not distressed, 2 = slightly distressed, 3 = moderately distressed, 4 = greatly distressed by pains.|Baseline, Month 12|All participants with an assessment.||participants|||Number
834790|NCT01273519|Secondary|Mean C-reactive Protein (CRP) at Baseline, and Months 3, 6, 9, and 12|The CRP is an acute phase reactant plasma protein, normally produced by the liver, which is commonly used as an indirect measure of the extent and activity of an inflammation. The CRP normal reference range in the blood is, as a rule, from 0 to 1.0 mg/dL.|Baseline, Months 3, 6, 9, 12|All participants with an assessment. n=number of participants with an assessment at time point.||mg/dL||Standard Deviation|Mean
834791|NCT01273519|Secondary|Mean Erythrocyte Sedimentation Rate (ESR) at Baseline, and Months 3, 6, 9, and 12|The ESR is a practicable and sensitive but not specific parameter for measuring disease progression. By means of the ESR it can be generally distinguished between an active and nonactive rheumatic disease. The normal reference range is, as a rule, 0 to 10 mm/h for men and 0 to 15 mm/h for women. The higher the ESR value out of the normal range, the higher is the disease activity.|Baseline, Months 3, 6, 9, 12|All participants with an assessment. n=number of participants with an assessment at time point.||mm/h||Standard Deviation|Mean
834792|NCT01273519|Secondary|Mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) for Participants With Ankylosing Spondylitis (AS) at Baseline, and Months 3, 6, 9, and 12|The BASDAI is used for measuring and evaluating disease activity in AS. This index consists of 6 questions pertaining to the 5 major symptoms of AS: fatigue, spinal pain, joint pain/swelling, areas of localized tenderness (or enthesitis, defined as inflammation of tendons and ligaments), duration of morning stiffness, severity of morning stiffness. A visual analogue scale ranging from 0 (none) to 10 (very severe) is used to answer the questions. The final BASDAI score averages the individual assessments for a final score range of 0-10 (0 being no problem and 10 being the worst problem).|Baseline, Months 3, 6, 9, 12|All participants with an assessment. n=number of participants with an assessment at time point.||units on a scale||Standard Deviation|Mean
834793|NCT01273519|Secondary|Mean Bath Ankylosing Spondylitis Functional Index (BASFI) Scores at Baseline, and Months 3, 6, 9, and 12|"The BASFI is a set of 10 questions designed to determine the degree of functional limitation in those with AS. The 10 questions were chosen with a major input from patients with AS. The first 8 questions consider activities related to functional anatomy. The final 2 questions assess the participants' ability to cope with everyday life. A visual analogue scale (with 0 being easy and 10 impossible”) is used to answer the questions on the test."|Baseline, Months 3, 6, 9, 12|Participants with AS or PsA and an assessment. n=number of participants with an assessment at time point.||units on a scale||Standard Deviation|Mean
834794|NCT01273519|Secondary|Mean Rheumatoid Arthritis Disease Activity Index (RADAI) at Baseline, and Months 3, 6, 9, and 12|The RADAI is a questionnaire for patients used for measuring disease activity. The index consists of 6 questions. The items ask the participants about (1) global disease activity in the last 6 months, (2) disease activity in terms of current swollen and tender joints, (3) arthritis pain, (4) the current status of health, (5) duration of morning stiffness and (6) tender joints to be rated in a joint list. The joint list asks about pain in the left and right shoulders, elbows, wrists, fingers, hips, knees, ankles and toes. The first 4 items are all rated on a numeric rating scale from 0 to 10, where higher scores indicate more disease activity. The scores on the last 2 items range from 0 to 6 and 0 to 48, respectively, but are transformed on the same scale of 0 to 10. The RADAI total score is the sum of individual items divided by 5 (range 0-10), with a higher score signifying more disease activity.|Baseline, Months 3, 6, 9, 12|All participants with an assessment. n=number of participants with an assessment at time point.||units on a scale||Standard Deviation|Mean
834795|NCT01273519|Secondary|Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores at Baseline, and Months 3, 6, 9, and 12|The HAQ-DI is a participant-reported questionnaire. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability. The minimal clinically important difference defined for the HAQ-DI is ≥0.22. HAQ remission, indicating normal physical function, is defined as HAQ-DI < 0.5.|Baseline, Months 3, 6, 9, 12|All participants with an assessment. n=number of participants with an assessment at time point.||units on a scale||Standard Deviation|Mean
834843|NCT01280591|Secondary|Cumulative Proportion of Subjects Taking Rescue Medication by Hour|If rescue medication was taken by a subject for pain, then the time of rescue medication administration was recorded|Up to 10 hours|Safety Population||participants|||Number
834796|NCT01273519|Secondary|Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12|The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1 to 4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5 to 8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 [worst] to 100 [best ]). The standard recall period is 4 weeks. Increases from Baseline indicate improvement.|Baseline, Months 3, 6, 9, 12|All participants with an assessment. n=number of participants with an assessment at time point.||units on a scale||Standard Deviation|Mean
834797|NCT01273519|Primary|Participant Assessment of the Presence of Nocturnal Pain Progression in the Past 3 Months at Baseline and Month 12|Participants assessed how often on average they noted the presence of nocturnal pain in the past 3 month according to the following descriptors: never; rarely (not exceeding once a week), every night (awake from sleep at least once a night), more than once a night per week.|Baseline, Month 12|All participants with an assessment.||participants|||Number
834798|NCT01273519|Primary|Participant Assessment of the Pattern of Pain Progression (Sudden/Creeping) in the Past 3 Months at Baseline and Month 12|Participants assessed the pattern of their pain progression in the past 3 months according to the following descriptors: the type of beginning of pain was mostly sudden; the type of beginning of pain was mostly creeping.|Baseline, Month 12|All participants with an assessment. n=number of participants with an assessment at time point.||participants|||Number
834799|NCT01273519|Primary|Participant Assessment of the Pattern of Pain Progression (Daytime/Nocturnal) in the Past 3 Months at Baseline and Month 12|Participants assessed the pattern of their pain progression in the past 3 months according to the following descriptors: intermittent (daytime and/or nocturnal); mostly daytime; mostly nocturnal; continuous (daytime and nocturnal).|Baseline, Month 12|All participants with an assessment. n=number of participants with an assessment at time point.||participants|||Number
834800|NCT01273519|Primary|Participant Assessment of Pain Intensity in the Past 3 Months Recorded on a Likert Scale at Baseline and Month 12|Participants measured their pain intensity in the past 3 months by specifying their level of pain in response to the question “How intensive was your pain on average in the past 3 months?” on a 4-point Likert scale, where 0 = no pain; 1 = mild pain, 2 = moderate pain, 3 = severe pain.|Baseline, Month 12|All participants with an assessment.||participants|||Number
834801|NCT01273519|Primary|Participant Assessment of Pain Intensity in the Past 3 Months Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12|Participants measured their pain intensity in the past 3 months on a visual analogue scale (VAS), where the responses were on a continuous range from 0 (no pain) to 100 (worst pain imaginable).|Baseline, Months 3, 6, 9, 12|All participants with an assessment. n=number of participants with an assessment at time point.||units on a scale||Standard Deviation|Mean
834802|NCT01273519|Primary|Participant Assessment of Present Pain Intensity Recorded on a Likert Scale at Baseline and Month 12|Participants measured their present pain intensity by specifying their level of pain in response to the question “How intensive is your pain at present?” on a 4-point Likert scale, where 0 = no pain; 1 = mild pain, 2 = moderate pain, 3 = severe pain.|Baseline, Month 12|All participants with an assessment at time point.||participants|||Number
834803|NCT01273519|Primary|Physician Assessment of Present Pain Intensity Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12|Physicians measured participants' present pain intensity on a visual analogue scale (VAS), where the responses were on a continuous range from 0 (no pain) to 100 (worst pain imaginable).|Baseline, Months 3, 6, 9, 12|All participants with an assessment. n=number of participants with an assessment at time point.||units on a scale||Standard Deviation|Mean
834804|NCT01273519|Primary|Participant Assessment of Present Pain Intensity Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12|Participants measured their present pain intensity on a visual analogue scale (VAS), where the responses were on a continuous range from 0 (no pain) to 100 (worst pain imaginable).|Baseline, Months 3, 6, 9, 12|All participants with an assessment. n=number of participants with an assessment at time point.||units on a scale||Standard Deviation|Mean
834805|NCT01273597|Secondary|Number of Participants With Hyperphosphataemia During 6 Months of Selective Vitamin D Receptor Activator (Paricalcitol) Treatment|Hyperphosphataemia (serum phosphorus > 1.78 mmol/L), based on laboratory data, was collected during the observed 6 months treatment with Zemplar (paricalcitol injection).|6 months|Participants with available retrospective data (cohort analyzed for Outcome Measure 8) were analyzed prospectively at Month 6 of treatment.||participants|||Number
834806|NCT01273597|Secondary|Number of Participants With Hyperphosphataemia During Preceding Conventional Vitamin D Therapy|Hyperphosphataemia (serum phosphorus >1.78 mmol/L) among participants during the preceding 6 months of conventional vitamin D therapy was derived from retrospective data collection in case report form, reported at baseline. Conventional vitamin D therapy included vitamin D supplement products from ATC group A11CC (vitamin D and analogues).|6 months prior to start of study through baseline|Participants with available retrospective data||participants|||Number
834807|NCT01273597|Secondary|Number of Participants With Hypercalcaemia During 6 Months of Selective Vitamin D Receptor Activator (Paricalcitol) Treatment|Hypercalcaemia (serum calcium > 2.6 mmol/L), based on laboratory data, was collected during the observed 6 months treatment with Zemplar (paricalcitol injection).|6 months|Participants with available retrospective data (cohort analyzed for Outcome Measure 6) were analyzed prospectively at Month 6 of treatment.||participants|||Number
834808|NCT01273597|Secondary|Number of Participants With Hypercalcaemia During Preceding 6 Months of Conventional Vitamin D Therapy|Hypercalcaemia (serum calcium > 2.6 mmol/L) among participants during the preceding 6 months of conventional vitamin D therapy was derived from retrospective data collection in case report form, reported at baseline. Conventional vitamin D therapy included vitamin D supplement products from ATC group A11CC (vitamin D and analogues).|6 months prior to start of study through baseline|Participants with available retrospective data||participants|||Number
834844|NCT01280591|Secondary|Time to Rescue Medication|If rescue medication was taken by a subject for pain, then the time of rescue medication administration was recorded|Up to 10 hours|ITT (Intent to Treat) Population||Minutes||95% Confidence Interval|Median
834809|NCT01273597|Secondary|Country–Specific Data on the Usage of Medication Affecting Secondary Hyperparathyroidism|If available, data on the use of medication affecting secondary hyperparathyroidism (those who received calcimimetics and calcium supplementation) in the 6 months leading up to paricalcitol treatment and during 6 months of paricalcitol treatment were also collected.|6 months prior to start of study through 6 months of treatment|This outcome measure was not analyzed due to lack of data.|||||
834810|NCT01273597|Secondary|Country–Specific Data on the Usage of Medication Affecting Phosphorus (P) Balance|If available, data on the use of phosphate binders (those who received calcium-based phosphate binders or sevelamer/lanthanum) in the 6 months leading up to paricalcitol treatment and during 6 months of paricalcitol treatment were also collected.|6 months prior to start of study through 6 months of treatment|This outcome measure was not analyzed due to lack of data.|||||
834811|NCT01273597|Secondary|Country–Specific Data on the Usage of Medication Affecting Calcium (Ca) Balance|If available, data on vitamin D treatment (those who received vitamin D supplement products from Anatomical Therapeutic Chemical [ATC] group A11CC [vitamin D and analogues]) in the 6 months leading up to paricalcitol treatment and during 6 months of paricalcitol treatment were also collected.|6 months prior to start of study through 6 months of treatment|This outcome measure was not analyzed due to lack of data.|||||
834812|NCT01273597|Secondary|Number of Participants Achieving Target Intact Parathyroid Hormone (iPTH) Levels at Month 6|Target intact parathyroid hormone (iPTH) values were within the target therapeutic range of 150 - 300 pg/mL, corresponding to 15.9 - 31.8 pmol/L.|6 months|All participants||participants|||Number
834813|NCT01273597|Primary|Time (in Weeks) From Treatment Initiation to Achieving Maintenance Dose of Zemplar (Paricalcitol Injection)|Maintenance dose is defined as weekly dose of paricalcitol that results in at least 2 consecutive intact parathyroid hormone (iPTH) values within the target therapeutic range of 150 - 300 pg/mL, corresponding to 15.9 - 31.8 pmol/L.|6 months|Participants who achieved maintenance dose of Zemplar (paricalcitol injection)||weeks||Standard Deviation|Mean
834814|NCT01273623|Secondary|Residual Diameter Stenosis|lumen diameter stenosis change post-atherectomy|Day 0|||percentage change||Standard Deviation|Mean
834815|NCT01273623|Secondary|Adjunctive Therapy Use||Day 0|||percentage of participants|||Number
834816|NCT01273623|Primary|Luminal Area Change|lumen area change as measured by intravascular ultrasound (IVUS)|Day 0|||mm^2||Standard Deviation|Mean
834817|NCT01273766|Secondary|Cumulative Incidence of Documented Bacterial, Fungal, and Viral Infections|Records will be assessed at baseline and prospectively while on study.|Baseline, up to 6 months||||||
834818|NCT01273766|Secondary|Need for Hospitalization, Ventilator Support, Exchange Transfusion/Apheresis or Treatment With Antifungals or Antibiotics|Records will be assessed at baseline and prospectively while on study.|Baseline, up to 6 months||||||
834819|NCT01273766|Primary|Changes in Mean Neutrophil Values (as Measured by Lab) for Arm 1 (Other Arms Were Used for Calibration Only)|Changes in Neutrophils between baseline and mean neutrophils values during treatment (measured after each dose)|Baseline, up to 6 months|||10^9 Neutrophils per Liter||Standard Deviation|Mean
834820|NCT01273805|Secondary|Grade 4-5 Treatment-Related Toxicity|All grade 4-5 adverse events with treatment attribution of possibly, probably or definite based on CTCAEv3 as reported on case report forms.|Adverse events were assessed each cycle throughout treatment. Participants were followed for the duration of treatment, an average of 34 days for this study population.|The analysis dataset is comprised of all treated patients.||Participants|||Count of Participants
834821|NCT01273805|Secondary|Progression-Free Survival|Progression-free survival based on the Kaplan-Meier method is defined as the duration of time from study entry to time of objective progression on CT scan or the time of death for patients with clinical deterioration resulting in withdrawal from the trial. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions. Patients without an event were censored at date of last disease evaluation.|Disease was evaluated radiologically at baseline and every 2 months on treatment. Median PFS follow-up in this study cohort was 46.5 days (95% CI 33-61).|The analysis dataset is comprised of all enrolled patients.||days||95% Confidence Interval|Median
834822|NCT01273805|Secondary|Overall Survival|Overall survival estimated using Kaplan-Meier (KM) methods is defined as the time from study entry to death or date last known alive.|All patients were followed until death. Median survival follow-up in this study cohort was 60 days (95% CI: 40-184).|The analysis dataset is comprised of all enrolled patients.||days||95% Confidence Interval|Median
834823|NCT01273805|Secondary|Tumor Response Rate|Tumor response rate is the percentage of patients achieving complete or partial response on treatment based on RECIST 1.0 criteria. For target lesions, complete response (CR) is disappearance of all target lesions and partial response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. CR for the evaluation of non-target lesions is the disappearance of non-target lesions and normalization of tumor marker level. Appearance of one or more new lesions is classified as progression of non-target lesions. CR or PR confirmation is required >/= 4 weeks.|Disease was evaluated radiologically at baseline and every 2 months on treatment. Median duration of treatment for this study cohort was 34 days.|The analysis dataset is comprised of all enrolled patients.||percentage of patients|||Number
834824|NCT01273805|Secondary|Biochemical Response Rate|Biochemical response rate was defined as the percentage of patients achieving on treatment a decrease in serum CA 19-9 by > 30% from baseline.|Disease was evaluated radiologically at baseline and every 2 months on treatment. Median duration of treatment for this study cohort was 34 days.|Biochemical response could not be estimated due to insufficient longitudinal CA 19-9 measurements. This was directly related to the observed lack of activity of the study drug and corresponding short duration of therapy.|||||
834838|NCT01280552|Secondary|Progression Free Survival in HLA- A2 Patients|"Progression Free Survival in a prespecified subpopulation of patients with HLA-A2 haplotype.
Intent to treat population includes all randomized patients. PFS is defined as the time from randomization until the date of documented progressive disease (PD) or death, whichever occurs first, or last date known alive and progression free if progression or death is not observed"|2-3 yers|HLA-A2 patients||months of progression free survival||95% Confidence Interval|Median
834825|NCT01273805|Primary|2-month Progression-Free Survival Rate|2-month progression-free survival rate was defined as the percentage of patients absent progression (PD) or death before 2 months. Patients were considered to have experienced PD if they demonstrated either clinical deterioration resulting in withdrawal or PD per RECIST 1.0 criteria: At least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.|Disease was evaluated radiologically at baseline and at the first restaging at 2 months.|The analysis dataset is comprised of all enrolled patients.||percentage of patients||95% Confidence Interval|Number
834826|NCT01273818|Primary|Number of Infections in Each Study Arm|Patients were examined on postoperative 30 days for the presence of surgical site infection.|within the 30 days after surgery|||infections|||Number
834827|NCT01273818|Primary|Rate of Post-operative Infection||within the first 30 days after surgery||||||
834828|NCT01273857|Secondary|Serious Adverse Events|The incidence of hospitalization for heart failure, ventricular arrhythmia, general infection, and renal and hepatic dysfunction by CDC treatment.|3 months to 1 year after cell transplantation|||participants|||Number
834829|NCT01273857|Primary|Feasibility Evaluation and Major Cardiac Adverse Events Related to Transcoronary Infusion of Cardiac Progenitor Cells|"Feasibility was assessed by number of participants discontinued the study due to adverse events or number of participants received unsuccessful cell delivery by study physician. Unsuccessful was defined as failure of coronary selection of guiding catheter or direct cell infusion.
The primary end point is to monitor major adverse cardiac events include death, sustained/symptomatic ventricular tachycardia, aggravation of heart failure, new myocardial infarction, unplanned cardiovascular operation for cardiac tamponade and infection in the first month after injection, and serially afterwards."|3 months to 1 year after cell transplantation|||participants|||Number
834830|NCT01273883|Secondary|Comparison of Average Tinnitus Handicap Inventory (THI) Across All Women|The Tinnitus Handicap Inventory measures the extent that tinnitus interferes with daily activities and sleep.The questionnaire consists of 25 questions, the score can range from 0 (slight problem) to 100 (catastrophic). The score can be converted to a categorical variable as follows: 0-16=Slight; 18-36=Mild; 38-56=Moderate; 58-76=Severe; 78-100=Catastrophic.|Pre-treatment, Post-treatment, up to four weeks|Not all the female subjects completed the THI questionnaire.||units on a scale||Standard Deviation|Mean
834831|NCT01273883|Secondary|Comparison of Average Tinnitus Handicap Inventory (THI) Across All Men|The Tinnitus Handicap Inventory measures the extent that tinnitus interferes with daily activities and sleep.The questionnaire consists of 25 questions, the score can range from 0 (slight problem) to 100 (catastrophic). The score can be converted to a categorical variable as follows: 0-16=Slight; 18-36=Mild; 38-56=Moderate; 58-76=Severe; 78-100=Catastrophic.|Pre-treatment, Post-treatment, up to four weeks|Not all male subjects completed the THI questionnaire.||units on a scale||Standard Deviation|Mean
834832|NCT01273883|Secondary|Comparison of Average Tinnitus Handicap Inventory (THI) Across All Subjects|The Tinnitus Handicap Inventory measures the extent that tinnitus interferes with daily activities and sleep.The questionnaire consists of 25 questions, the score can range from 0 (slight problem) to 100 (catastrophic). The score can be converted to a categorical variable as follows: 0-16=Slight; 18-36=Mild; 38-56=Moderate; 58-76=Severe; 78-100=Catastrophic.|Pre-treatment, Post-treatment, up to four weeks|Not all subjects completed the THI questionnaire.||units on a scale||Standard Deviation|Mean
834833|NCT01273883|Primary|Tinnitus Distress Rating|This is a single-item patient-reported distress rating on a 0-10 scale, with 0=no tinnitus to 10=worst possible tinnitus.|Pre-treatment, Post-treatment, up to four weeks|Not all subjects completed the distress rating scale.||units on a scale||Standard Deviation|Mean
834834|NCT01273896|Primary|Overall Response Rate|To determine the overall response rate using RECIST v 1.1 criteria, defined as PR +CR.using RECIST v 1.1 criteria, defined as Partial response + complete response|Radiological imaging studies to evaluate tumor status will be repeated during the rest week (Days 22 to 28) of every third cycle|||participants|||Number
834835|NCT01280357|Primary|The Mean Positive Percentage Agreement (PPA) for Maternal Heart Between Device 1 Monica AN24 & Device 2 Philips 50XM|During Labor & delivery, maternal heart rate was measured between the Monica AN24 & the Philips 50XM and the waveforms of the 2 devices were measured to see the percentage of time they were in agreement.|during labor and delivery the waveforms were measured for between 35 minutes and 15 hours during the first and second stage of labour|"Of the remaining 34 participants in the clinical trials.The data was collected in the following manner.
31 participants were used in a FDA 6 way trial for Fetal Heart Rate (FHR)and Uterine Activity (UA) 2 participants were uesd in a 3 way trial for FHR
1 participant was used in a 3 way trial for UA Equates to 33 files for FHR & 32 files for UA"||Positive percantage agreement (PPA)||95% Confidence Interval|Mean
834836|NCT01280357|Primary|The Mean Positive Percentage Agreement (PPA) for Fetal Heart Between Device 1 Monica AN24 & Device 2 Philips 50XM|During Labor & delivery, fetal heart rate was measured between the Monica AN24 & the Philips 50XM and the waveforms of the 2 devices were measured to see the percentage of time they were in agreement.|during labor and delivery the waveforms were measured for between 35 minutes and 15 hours during the first and second stage of labour|"Of the remaining 34 participants in the clinical trials.The data was collected in the following manner.
31 participants were used in a FDA 6 way trial for Fetal Heart Rate (FHR)and Uterine Activity (UA) 2 participants were uesd in a 3 way trial for FHR
1 participant was used in a 3 way trial for UA Equates to 33 files for FHR & 32 files for UA"||Positive percantage agreement (PPA)||95% Confidence Interval|Mean
834837|NCT01280357|Secondary|The Mean Positive Percentage Agreement for Uterine Contractions Between the Monica AN24 & The Philips 50XM|During labor and delivery uterine contractions were measured between the Monica AN24 & the philips 50XM, the waveforms of the two devices were measured to see the percentage of time they were in agreement|between 35 mins & 15hrs during first & second stage labor|"Of the remaining 34 participants in the clinical trials.The data was collected in the following manner.
31 participants were used in FDA 6 way trial for Fetal Heart Rate (FHR) and Uterine Activity (UA) 2 participants were used in a 3 way trial for FHR
1 participant was used in a 3 way trial for UA Equates to 33 files for FHR & 32 files for UA"||Positive Percentage Agreement (PPA)||95% Confidence Interval|Mean
834864|NCT01280604|Secondary|Aspartate Aminotransferase (AST)|AST levels will be assessed in study participants 6-10 weeks after entry into study.|6-10 weeks|||international units/liter||Standard Deviation|Mean
834845|NCT01280591|Secondary|Overall Rating of Pain Relief|"The Pain Relief Rating Scale was a 5-point categorical scale which included the following possible responses to the request to finish statement Overall, the relief from my starting pain was: no relief (0); a little relief (1); some relief (2); a lot of relief (3); complete relief (4)."|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)||Participants|||Number
834846|NCT01280591|Secondary|Change From Baseline in Pain Intensity|Pain Severity was collected on a 4-point categorical scale: 0=no pain, 1=mild pain, 2=moderate pain, 4=severe pain|Baseline and up to 10 hours|ITT (Intent to Treat) Population||Scores on a scale||Standard Deviation|Mean
834847|NCT01280591|Secondary|Subjective Sleep Questionnaire - Number of Minutes You Think That You Were Awake From the Time You Fell Asleep Until the Time You Got Out of Bed|Subjects responded to Estimate of the amount of time the subject was awake from the time he or she fell asleep until the time he or she got out of bed (hours and minutes)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)||Minutes||Standard Deviation|Mean
834848|NCT01280591|Secondary|Subjective Sleep Questionnaire - Time to Fall Asleep Last Night|Subjects responded to Estimate of how long it took to fall asleep (minutes)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)||Minutes||Standard Deviation|Mean
834849|NCT01280591|Secondary|Subjective Sleep Questionnaire - Refreshing Nature of Your Sleep Last Night|Subjects responded to Refreshing nature of sleep (10-point scale, where 1 was not refreshing and 10 was very refreshing)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)||Scores on a scale||Standard Deviation|Mean
834850|NCT01280591|Secondary|Subjective Sleep Questionnaire - Quality of Your Sleep Last Night|Subjects responded to Quality of sleep (10-point scale, where 1 was poor and 10 was excellent)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)||Scores on a scale||Standard Deviation|Mean
834851|NCT01280591|Secondary|Karolinska Sleep Diary - Sufficient Sleep|Subjects responded to the following question: Did you get enough (sufficient) sleep? no, definitely too little (1); no, much too little (2); no, somewhat too little (3); yes, almost enough (4); yes, definitely enough (5)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)||Participants|||Number
834852|NCT01280591|Secondary|Karolinska Sleep Diary - Well Rested|Subjects responded to the following question: Well Rested? not rested at all (1); somewhat unrested (2); completely rested (3)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)||Participants|||Number
834853|NCT01280591|Secondary|Karolinska Sleep Diary - Ease of Awakening|Subjects responded to the following question: Ease of awakening? (1) very difficult; (2) rather difficult; (3) neither difficult nor easy; (4) rather easy; very easy (5)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)||Participants|||Number
834854|NCT01280591|Secondary|Karolinska Sleep Diary - Premature Awakening|Subjects responded to the following question: Premature awakening? woke up much too early (1); woke up somewhat too early (2); no (3)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)||Participants|||Number
834855|NCT01280591|Secondary|Karolinska Sleep Diary - Easiness to Fall Asleep|Subjects responded to the following question: How easy was it to fall asleep? very difficult (1); rather difficult (2); neither difficult nor easy (3); rather easy (4); very easy (5)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)||Participants|||Number
834856|NCT01280591|Secondary|Karolinska Sleep Diary - Calmness of Sleep|Subjects responded to the following question: How calm was your sleep? very restless (1); rather restless (2); neither restless nor calm (3); rather calm (4); very calm (5)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)||Participants|||Number
834857|NCT01280591|Secondary|Karolinska Sleep Diary - Sleep Quality|Subjects responded to the following question: How was your sleep? very poor (1); rather poor (2); neither poor nor good (3); rather good (4); very good (5)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)||Participants|||Number
834858|NCT01280591|Secondary|Global Assessment of Investigational Product as a Sleep Aid|The Global Assessment of Investigational Product as a Sleep-Aid was rated using a 5-point categorical scale for which the potential response was poor (0), fair, (1), good (2), very good (3), or excellent (4).|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)||Participants|||Number
834859|NCT01280591|Secondary|Sleep Efficiency Measured by Actigraphy|Sleep efficiency was calculated as (total sleep time/total time in-bed time) × 100; total in-bed time was fixed at 10 hours. Actigraphy is a non-intrusive tool that measures an individual’s movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.|Up to 10 hours|ITT (Intent to Treat) Population||Percent of sleep time during in-bed time||95% Confidence Interval|Least Squares Mean
834860|NCT01280591|Secondary|Total Sleep Time Measured by Actigraphy|Total time time was measured as total time spent sleeping (not to exceed 600 minutes) during the in-bed period as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual’s movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.|Up to 10 hours|ITT (Intent to Treat) Population||Minutes||95% Confidence Interval|Least Squares Mean
834861|NCT01280591|Primary|Sleep Latency Measured by Actigraphy|Sleep latency was defined as the time to sleep onset from the time of dosing as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual’s movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.|Up to 10 hours|ITT (Intent to Treat) Population||Minutes||95% Confidence Interval|Median
834862|NCT01280591|Primary|Wake Time After Sleep Onset (WASO) Measured by Actigraphy|WASO was defined as Total wake time (in minutes) after sleep onset during the 10 hours in-bed period as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual’s movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.|Up to 10 hours|ITT (Intent to Treat) Population||Minutes||95% Confidence Interval|Least Squares Mean
834863|NCT01280604|Secondary|Serum Creatinine(SCr)|SCr levels will be assessed in study participants 6-10 weeks after entry into study.|6-10 weeks|||milligram/deciliter||Standard Deviation|Mean
834869|NCT01280955|Secondary|TNF-alpha at Day 14|TNF-alpha at day 14; Tumor necrosis factor is a cell signaling protein (cytokine) involved in systemic inflammation and is one of the cytokines that make up the acute phase reaction. The primary role of TNF is in the regulation of immune cells.|14 days|the population includes subject for which we have data at Day 14.||pg/mL||Full Range|Median
834870|NCT01280955|Secondary|TNF-alpha at Day 7|TNF-alpha at day 7; Tumor necrosis factor is a cell signaling protein (cytokine) involved in systemic inflammation and is one of the cytokines that make up the acute phase reaction. The primary role of TNF is in the regulation of immune cells.|7 days|the population includes subject for which we have data at Day 7.||pg/mL||Full Range|Median
834871|NCT01280955|Secondary|IFN Gamma at Day 14|IFN gamma at day 14; Interferon gamma (IFNγ) is a dimerized soluble cytokine that is the only member of the type II class of interferons which are important for immunity against infection.|14 days|the population includes subject for which we have data at Day 14.||pg/mL||Full Range|Median
834872|NCT01280955|Secondary|IFN Gamma at Day 7|IFN gamma at day 7; Interferon gamma (IFNγ) is a dimerized soluble cytokine that is the only member of the type II class of interferons which are important for immunity against infection.|7 days|the population includes subject for which we have data at Day 7.||pg/mL||Full Range|Median
834873|NCT01280955|Secondary|IL-12 at Day 14|IL-12 at day 14; Interleukin 12 (IL-12) is an interleukin that is naturally produced by dendritic cells, macrophages, neutrophils, and human B-lymphoblastoid cells (NC-37) in response to antigenic stimulation.|14 days|the population includes all participants for which we have data at day 14||pg/mL||Full Range|Median
834874|NCT01280955|Secondary|IL-12 at Day 7|IL-12 at day 7; Interleukin 12 (IL-12) is an interleukin that is naturally produced by dendritic cells, macrophages, neutrophils, and human B-lymphoblastoid cells (NC-37) in response to antigenic stimulation.|7 days|the population includes all participants for which we have data at day 7||pg/mL||Full Range|Median
834875|NCT01280955|Secondary|B Cell Count at Day 60|B cell count at Day 60; B cells, also known as B lymphocytes, are a type of white blood cell of the lymphocyte subtype and they function as part of the immune system.|60 days|the population includes subjects for which we have data at Day 60.||number of B cells||Full Range|Median
834876|NCT01280955|Secondary|B Cell Count at Day 30|B cell count at Day 30; B cells, also known as B lymphocytes, are a type of white blood cell of the lymphocyte subtype and they function as part of the immune system.|30 days|the population includes subjects for which we have data at Day 30.||number of B cells||Full Range|Median
834877|NCT01280955|Secondary|NK Cell Count at Day 60|NK cell count at Day 60;Natural killer cells or NK cells are a type of cytotoxic lymphocyte critical to the immune system.|60 days|the population includes subjects for which we have data at Day 60.||number of NK cells||Full Range|Median
834878|NCT01280955|Secondary|NK Cell Count at Day 30|NK cell count at Day 30;Natural killer cells or NK cells are a type of cytotoxic lymphocyte critical to the immune system.|30 days|the population includes subjects for which we have data at Day 30.||number of NK cells||Full Range|Median
834879|NCT01280955|Secondary|CD8 Cell Count at Day 60|CD8 cell count at Day 60; CD8 (cluster of differentiation 8) is a transmembrane glycoprotein that serves as a co-receptor for the T cell receptor (TCR).|60 days|the population includes subjects for which we have data at day 60||number of CD8 cells||Full Range|Median
834880|NCT01280955|Secondary|CD8 Cell Count at Day 30|CD8 cell count at Day 30; CD8 (cluster of differentiation 8) is a transmembrane glycoprotein that serves as a co-receptor for the T cell receptor (TCR).|30 days|the population includes subjects for which we have data at day 30||number of CD8 cells||Full Range|Median
834881|NCT01280955|Secondary|CD4 Cell Count at Day 60|CD4 cell count at Day 60; CD4+ T helper cells are white blood cells that are an essential part of the human immune system. They are often referred to as CD4 cells, T-helper cells or T4 cells.|60 days|The population includes subjects for which we have data at day 30.||number of CD4 cells||Full Range|Median
834882|NCT01280955|Secondary|CD4 Cell Count at Day 30|CD4 cell count at Day 30; CD4+ T helper cells are white blood cells that are an essential part of the human immune system. They are often referred to as CD4 cells, T-helper cells or T4 cells.|30 days|The population includes subjects for which we have data at day 30.||number of CD4 cells||Full Range|Median
834883|NCT01280955|Secondary|TNF-alpha at Day 30|TNF-alpha at day 30; Tumor necrosis factor is a cell signaling protein (cytokine) involved in systemic inflammation and is one of the cytokines that make up the acute phase reaction. The primary role of TNF is in the regulation of immune cells.|30 days|the population includes subject for which we have data at Day 30.||pg/mL||Full Range|Median
834884|NCT01280955|Secondary|IFN Gamma at Day 30|IFN gamma at day 30; Interferon gamma (IFNγ) is a dimerized soluble cytokine that is the only member of the type II class of interferons which are important for immunity against infection.|30 days|the population includes subject for which we have data at Day 30.||pg/mL||Full Range|Median
834885|NCT01280955|Secondary|B Cell Count at Day 90|B cell count at Day 90; B cells, also known as B lymphocytes, are a type of white blood cell of the lymphocyte subtype and they function as part of the immune system.|90 days|the population includes subjects for which we have data at Day 90.||number of B cells||Full Range|Median
834886|NCT01280955|Secondary|NK Cell Count at Day 90|NK cell count at Day 90;Natural killer cells or NK cells are a type of cytotoxic lymphocyte critical to the immune system.|90 days|the population includes subjects for which we have data at Day 90.||number of NK cells||Full Range|Median
834887|NCT01280955|Secondary|CD8 Cell Count at Day 90|CD8 cell count at Day 90; CD8 (cluster of differentiation 8) is a transmembrane glycoprotein that serves as a co-receptor for the T cell receptor (TCR).|90 days|the population includes subjects for which we have data at day 90||number of CD8 cells||Full Range|Median
834888|NCT01280955|Secondary|CD4 Cell Count at Day 90|CD4 cell count at Day 90; CD4+ T helper cells are white blood cells that are an essential part of the human immune system. They are often referred to as CD4 cells, T-helper cells or T4 cells.|90 days|The population includes subjects for which we have data at day 90.||number of CD4 cells||Full Range|Median
834889|NCT01280955|Secondary|CD3+ Cell Count at Day 90|Cell reconstitution - CD3+ cell count at day 90 post transplant. This is a marker for the function of your immune system.|90 Days|the population includes all participants for which we have data at day 90||number of CD3+ cells||Full Range|Median
837968|NCT01309893|Primary|Distance High Contrast logMAR Visual Acuity at 1 Week|Mean difference in distance high contrast logMAR over all lens VAs (visual acuity) from Baseline and 1 Week|Baseline & 1 week|All eligible, dispensed eyes||logMAR|Participants|Standard Deviation|Least Squares Mean
834890|NCT01280955|Secondary|Participants Experiencing Grade II-IV Acute Graft Versus Host Disease|We are reporting on the number of participants experiencing a grade II-IV acute graft versus host disease will be assessed weekly through Day 100 post transplant. Staging and grading of Acute GvHD is graded by pattern of organ involvement and clinical performance status using the Grading Index of Acute GvHD (Gluckman) and the Grading Index of Acute GVHD by the CIBMTR (Centers for International Blood and Marrow Transplant Research)|100 days|||participants|||Number
834891|NCT01280955|Secondary|IL-12 at Day 30|IL-12 at day 30; Interleukin 12 (IL-12) is an interleukin that is naturally produced by dendritic cells, macrophages, neutrophils, and human B-lymphoblastoid cells (NC-37) in response to antigenic stimulation.|30 days|the population includes all participants for which we have data at day 30||pg/mL||Full Range|Median
834892|NCT01280955|Secondary|Absolute Lymphocyte Count at Day 90|Cell reconstitution - absolute lymphocyte count at day 90 post transplant.|90 days|the population includes all participants for which we have data at day 90||number of lymphocytes||Full Range|Median
834893|NCT01280955|Secondary|Transplant-related Mortality||100 Days Post Transplant|Out of the 30 transplant recipients, one participant withdrew and was therefore not analyzed||participants|||Number
834894|NCT01280955|Primary|Plerixafor-associated Adverse Events||100 Days Post Transplant|Out of the 30 transplant recipients, one participant withdrew and was therefore not analyzed||number of adverse events|||Number
834895|NCT01280955|Primary|Time to Platelet Recovery|platelet > 20,000/ul on 2 consecutive days|100 Days Post Transplant|Out of the 30 transplant recipients, one participant withdrew and was therefore not analyzed||days||95% Confidence Interval|Median
834896|NCT01280955|Primary|Time to Neutrophil Recovery|leukocytes > 500/ul on 2 consecutive days|100 Days post Transplant|Out of the 30 transplant recipients, one participant withdrew and was therefore not analyzed||days||95% Confidence Interval|Median
834897|NCT01280968|Primary|Vaccination-Induced Percent Change in Initial Slope of Brain Nicotine Accumulation After a Single Puff||measured at week 1 and week 16|||percentage of change||Standard Error|Mean
834898|NCT01280968|Primary|Vaccination-Induced Percent Change in T1/2 of Brain Nicotine Accumulation After Single or Multiple (7) Puffs|"There was a 2 hour washout period between the single puff and multiple puffs assessments."|measured at week 1 and week 16|||percentage of change||Standard Error|Mean
834899|NCT01280968|Primary|Vaccine-Induced Percent Change in Brain Nicotine Maximum Concentration After Single or Multiple (7) Puffs|"There was a 2 hour washout period between the single puff and multiple puffs assessments."|measured at week 1 and week 16|||percentage of change||Standard Error|Mean
834900|NCT01280968|Primary|Vaccine-Induced Percent Change in Brain Nicotine Area Under Curve (AUC) After Single or Multiple (7) Puffs|"There was a 2 hour washout period between the single puff and multiple puffs assessments."|measured at week 1 and week 16|||percentage of change||Standard Error|Mean
834901|NCT01280981|Secondary|Mean Fridericia-corrected QT Interval (QTcFRI) at Month 9|The QT interval is the period that extends from the beginning of ventricular depolarization until the end of ventricular repolarization|Month 9|Intent to treat participants who had an electrocardiogram (ECG) at month 9||milliseconds||Standard Deviation|Mean
834902|NCT01280981|Secondary|Mean Intraocular Pressure at Month 9|Mean intraocular pressure at month 9 or the early termination visit.|Day 1 up to Month 9|Intent to treat participants who had ophthalmic exams.||mmHg||Standard Deviation|Mean
834903|NCT01280981|Secondary|Participants With Treatment Emergent Adverse Experiences (TEAE) of Laboratory Values Related to Treatment|Participants whose laboratory examinations (hematology, blood chemistry and urinalysis) were considered by the investigator to be treatment emergent adverse experiences (TEAE) and related to treatment. Also indicated is whether the TEAE lab parameter caused the participant to discontinue from the study.|Day 1 to up to Month 9|Intent to treat population||participants|||Number
834904|NCT01280981|Secondary|Mean Blood Pressure Measurements at Week 36|Mean systolic and diastolic blood pressure measurements taken at week 36|approximately week 36|Intent to treat population of participants with week 36 blood pressure data.||mmHg||Standard Deviation|Mean
834905|NCT01280981|Secondary|Participants With Abnormal Gynecological Examinations|Participants with abnormal gynecological examination findings based on endometrial biopsies and transvaginal ultraonogrphy (TVU) are summarized. Clinically significant results from the endometrial biopsies are results that are not benign. Abnormalities found during transvaginal ultrasonography (TVU) are detailed in the AE listings. Please refer to AE listings.|Day 1 to up to Month 9|Intent to treat population||participants|||Number
834906|NCT01280981|Primary|Participants With Treatment-Emergent Adverse Events (AEs)|Count of participants with treatment-emergent adverse events grouped in categories regarding relationship to study drug as assessed by the investigator, serious or life-threatening as assessed by the investigator, participants who died or their event led to withdrawal from study, and participants who experienced thrombotic or thromboembolic AEs.|Day 1 to up to Month 9|Intent to treat population (ITT)||participants|||Number
834907|NCT01281007|Secondary|Safety Will be Evaluated by the Adverse Events Occurence|Adverse events will be collected and followed in order to evaluate safety and tolerability|Day 5||||||
834908|NCT01281007|Primary|Efficacy Will be Evaluated by the Proportion of Subjects With Non Herpes Manifestation|Symptoms evaluated: erythema, papule, vesicle, ulcer, crust, or healed skin.|Day 5|||subjects|||Number
834909|NCT01281124|Secondary|Progression-free Survival|Analyzed using a Kaplan-Meier methods.|From the day of initial treatment until documented disease progression (per PET) or death, assessed up to 12 weeks after completion of study treatment|Data analysis was not done due to low accrual for this trial.|||||
834910|NCT01281124|Secondary|Overall Survival|Analyzed using a Kaplan-Meier methods.|From the day of initial treatment until death (from any cause), assessed up to 12 weeks after completion of study treatment|Data analysis was not done due to low accrual for this trial.|||||
834911|NCT01281124|Primary|DNA Hypomethylation and Re-expression of Silenced Tumor Suppressor Genes When Stratified for Low or High Expression of mir29|The change in mean methylation of the genes between the patients with a low mir29 and a high mir29 expression will be evaluated by a two-sample t-test. Secondary analyses include a multivariate regression where all 5 changes in methylation will be regressed on mir29 expression (low vs. high) and adjusted for patient demographic and clinical attributes at baseline.|Up to 12 weeks after completion of study treatment|Data analysis was not done due to low accrual for this trial.|||||
834912|NCT01281202|Secondary|Number of Participants With Cocaine Use||Week 3 - 9|||participants|||Number
834915|NCT01281306|Secondary|Number of Participants Who Achieved Blood Pressure Control and Blood Pressure Response|Sitting BP measurements were performed at trough (23-26 hours post-morning dose). Blood pressure control was defined as msSBP/MSDBP < 140/90 mmHg. Blood pressure response in msSBP was defined as <140 mmHg or a reduction >= 20mmHg from baseline. Blood pressure response in msDBP was defined as < 90 mmHg or a reduction >= 10 mmHg from baseline.|8 weeks|Only participants of the full analysuis set (FAS), who had week 8 measurements, were included in the analysis. The FAS included all randomized participants who received at least one dose of double-blind study medication.||Number of participants|||Number
834916|NCT01281306|Secondary|Change From Baseline in maSBP and maDBP in Participants >= 65 Years of Age|Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. A negative change from baseline indicates improvement.|Baseline, 8 weeks|A subset of randomized participants, who were >= 65 years of age and had ABPM measurements at both baseline and week 8, were included in the analysis.||mmHg||Standard Error|Least Squares Mean
834917|NCT01281306|Secondary|Change From Baseline in maSBP and maDBP in Participants < 65 Years of Age|Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. A negative change from baseline indicates improvement.|Baseline, 8 weeks|A subset of randomized participants, who were leass than 65 years of age and had ABPM measurements at both baseline and week 8, were included in the analysis.||mmHg||Standard Error|Least Squares Mean
834918|NCT01281306|Secondary|Change From Baseline in msSBP and msDBP in Participants >= 65 Years of Age|Sitting BP measurements were performed at trough (23-26 hours post-morning dose). A negative change from baseline indicates improvement.|Baseline, 8 weeks|Only participants of the full analysuis set (FAS), who were >= 65 years of age and had measurements at both baseline and week 8, were included in the analysis. The FAS included all randomized participants who received at least one dose of double-blind study medication.||mmHg||Standard Error|Least Squares Mean
834919|NCT01281306|Secondary|Change From Baseline in msSBP and msDBP in Participants < 65 Years of Age|Sitting BP measurements were performed at trough (23-26 hours post-morning dose). A negative change from baseline indicates improvement.|Baseline, 8 weeks|Only participants of the full analysuis set (FAS), who were < 65 years of age and had measurements at both baseline and week 8, were included in the analysis. The FAS included all randomized participants who received at least one dose of double-blind study medication.||mmHg||Standard Error|Least Squares Mean
834920|NCT01281306|Secondary|Change From Baseline in maSBP and maDBP in Non-dippers|Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. Dippers were defined as participants who showed a decrease of at least 10% in maSBP during the night (10pm-6am) compared with the daytime level. A negative change from baseline indicates improvement.|Baseline, 8 weeks|A subset of randomized participants, who had ABPM measurements at both baseline and week 8, were included in the analysis.||mmHg||Standard Error|Least Squares Mean
834921|NCT01281306|Secondary|Change From Baseline in maSBP and maDBP in Dippers|Twenty four hour ABPM was performed twice during the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. Dippers were defined as participants who showed a decrease of at least 10% in maSBP during the night (10pm-6am) compared with the daytime level. A negative change from baseline indicates improvement.|Baseline, 8 weeks|A subset of randomized participants, who had ABPM measurements at both baseline and week 8, were included in the analysis.||mmHg||Standard Error|Least Squares Mean
834922|NCT01281306|Secondary|Change From Baseline in Mean Ambulatory Pulse Pressure|Pulse rate measurements were performed. A negative change from baseline indicates improvement.|Baseline, 8 weeks|A subset of randomized participants, who had ABPM measurements at both baseline and week 8, were included in the analysis.||mmHg||Standard Error|Least Squares Mean
834923|NCT01281306|Secondary|Change From Baseline in Mean Sitting Pulse Pressure|Pulse rate measurements were performed. A negative change from baseline indicates improvement.|Baseline, 8 weeks|Only participants of the full analysis set (FAS), who had measurements at both baseline and week 8, were included in the analysis. The FAS included all randomized participants who received at least one dose of double-blind study medication.||mmHg||Standard Error|Least Squares Mean
834924|NCT01281306|Secondary|Change From Baseline in Nighttime maSBP and maDBP|Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. A negative change from baseline indicates improvement.|Baseline and 8 weeks|A subset of randomized participants, who had ABPM measurements at both baseline and week 8, were included in the analysis.||mmHg||Standard Error|Least Squares Mean
834925|NCT01281306|Secondary|Change From Baseline in Daytime maSBP and maDBP|Twenty four hour ABPM was performed twice during the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. A negative change from baseline indicates improvement.|Baseline, 8 weeks|A subset of randomized participants, who had ABPM measurements at both baseline and week 8, were included in the analysis.||mmHg||Standard Error|Least Squares Mean
834926|NCT01281306|Secondary|Change From Baseline in Mean 24 Hour Ambulatory SBP (maSBP) and Mean 24 Hour Ambulatory DBP (maDBP)|Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. A negative change from baseline indicates improvement.|Baseline, 8 weeks|A subset of randomized participants, who had ABPM measurements at both baseline and week 8, were included in the analysis.||mmHg||Standard Error|Least Squares Mean
834927|NCT01281306|Secondary|Change From Baseline in Mean Diastolic Blood Pressure (msDBP)|Sitting BP measurements were performed at trough (23-26 hours post-morning dose). A negative change from baseline indicates improvement.|Baseline, 8 weeks|Only participants of the full analysuis set (FAS), who had measurements at both baseline and week 8, were included in the analysis. The FAS included all randomized participants who received at least one dose of double-blind study medication.||mmHg||Standard Error|Least Squares Mean
837969|NCT01309919|Secondary|Insertion Time|Time of insertion of the IUD|immediate|||minutes||Standard Deviation|Mean
834928|NCT01281306|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)|Sitting BP measurements were performed at trough (23-26 hours post-morning dose). A negative change from baseline indicates improvement.|Baseline, 8 weeks|Only participants of the full analysuis set (FAS), who had measurements at both baseline and week 8, were included in the analysis. The FAS included all randomized participants who received at least one dose of double-blind study medication.||mmHg||Standard Error|Least Squares Mean
834929|NCT01281475|Secondary|Presence of Tremors||1 year|||Participants|||Count of Participants
834930|NCT01281475|Primary|Bayley Cognitive Age Equivalent at 1 Year||12 months|||months||Standard Deviation|Mean
834931|NCT01281501|Secondary|Number of Participants That Have Overall Satisfaction on the Treatment|The satisfaction will be assessed by a simple, self-reported yes/no question.|1 hour after treatment|||participants|||Number
834932|NCT01281501|Secondary|Number of Participants With Adverse Effect|The adverse effects include blurred vision, dry mouth, dizziness, headache, palpitation and diarrhea.|1 hour after treatment||||||
834933|NCT01281501|Secondary|"Number of Participants in the Predefined Non-responders"|“Non-responders” defined the participants who had < 50% decrease in post-treatment VAS compared with pre-treatment evaluation or post-treatment scores > 40 at the end of the study.|pretreatment and 1 hour after treatment|||participants|||Number
834934|NCT01281501|Secondary|"Number of Participants in the Predefined Responders"|"Responders define the participants who have ≥ 50% decrease in post-treatment pain scores compared with the pre-treatment evaluation and also have the post-treatment scores ≤ 40 at the end of the study."|pretreatment and 1 hour after treatment|||participants|||Number
834935|NCT01281501|Primary|Pain Scores on the 100-millimeter Visual Analog Scale (VAS) at 1 Hour After Treatment|Post-treatment VAS will be consecutively measured every 15 minutes until 1 hour after treatment. Minimal and maximal VAS score of every measurement is 0 to 100 millimeters. VAS scores at 1 hour after treatment were the primary outcome measurement. The patients who had <50% decrement between pre- and 1-hour post-treatment VAS or post-treatment scores > 40 millimeters were defined as “Non-responders”(worse outcome). In the same way, those who had ≥ 50% decrement between pre- and 1-hour post-treatment VAS and post-treatment scores≤ 40 millimeters were defined as “Responders” (good outcome).|1 hour after treatment|All enrolled patients were analyzed with the intention-to-treat principles.||millimeter||Standard Deviation|Mean
834936|NCT01281644|Secondary|Patient Self-rated Severity|This outcome measure was the difference in disease severity total score, combining redness and roughness/bumpiness scales, between the treated site and the control site, as rated by the patient at 12 weeks post-initial visit. These scales were not validated, as no relevant validated scale was available. Each scale ranged from 0 to 3, with 0 being none and 3 being severe. The total score summed the redness and roughness/bumpiness scale scores for a range of 0 (none/better outcome) to 6 (severe/worse outcome).|12 weeks|||units on a scale|Participants|Inter-Quartile Range|Median
834937|NCT01281644|Primary|Difference in Disease Severity Scores|The primary outcome measure was the difference in disease severity total score, combining redness and roughness/bumpiness scales, between the treated site and the control site, as rated by the blinded dermatologists at 12 weeks post-initial visit. These scales were not validated, as no relevant validated scale was available. However, raters were trained and calibrated on the use of the scale, and prior to review of study images, were asked to rate archival skin images on the same 4-point qualitative subscales used in the study. Each scale ranged from 0 to 3, with 0 being none and 3 being severe. The total score summed the redness and roughness/bumpiness scale scores for a range of 0 (none/better outcome) to 6 (severe/worse outcome).|12 weeks|||units on a scale|Participants|Inter-Quartile Range|Median
834938|NCT01281839|Secondary|Plasma Concentration of TMC435: Systemic Clearance (CL)|The table below shows mean (standard deviation) of CL values of TMC435. To calculate the mean CL for the study, CL values were derived for each participant at each visit and then the median of CL values across visits for each participant was used to calculate the mean CL for the study.|From the time of administration through Week 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||L/h||Standard Deviation|Mean
834939|NCT01281839|Secondary|Plasma Concentration of TMC435: Predose Plasma Concentration (C0h)|The table below shows mean (standard deviation) of C0h values of TMC435. To calculate the mean C0h for the study, C0h values were derived for each participant at each visit and then the median of C0h values across visits for each participant was used to calculate the mean C0h for the study.|Before administration of TMC435 through Week 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||ng/mL||Standard Deviation|Mean
834940|NCT01281839|Secondary|Plasma Concentration of TMC435: Area Under the Plasma Concentration-time Curve From the Time of Administration to 24 Hours After Dosing (AUC24h)|The table below shows mean (standard deviation) values of the area under the plasma concentration-time curve from time of administration to 24 hours (AUC 24hr) after dosing for TMC435. To calculate the mean AUC 24 for the study, AUC 24 hr values were derived for each participant at each visit and then the median of AUC value across visits for each participant was used to calculate the mean AUC 24 hr for the study.|From the time of administration up to 24 hours after dosing through Week 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||ng*h/mL||Standard Deviation|Mean
834941|NCT01281839|Secondary|Median Time to Normalization of Alanine Aminotransferase (ALT) Levels|The table below shows the median time to normalization of ALT levels.|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Weeks||95% Confidence Interval|Median
834942|NCT01281839|Secondary|The Percentage of Participants With Normalization of Alanine Aminotransferase (ALT)|The percentage of participants analyzed were those with baseline ALT values out of the normal range (ie, 156 of 260 participants in the TMC435 treatment group and 84 of 133 participants in the Placebo group had ALT values at baseline that were out of the normal range.). Normalization of ALT values means that ALT values out of the normal range returned to within the normal range.|Up to Week 48|Participants with baseline ALT values out of normal range were used for this analysis from intent-to treat population (defined as all participants who were randomized and received at least one dose of study medication).||Percentage of Participants|||Number
834943|NCT01281839|Secondary|Time From End-of-treatment to Viral Relapse|The table below shows the mean number of days to viral relapse, defined as participants having confirmed detectable plasma level of Hepatitis C Virus (HCV) ribonucleic acid (RNA) during the follow-up period in participants with undetectable plasma HCV RNA (<25 IU/mL undetectable) at the end of treatment.|Up to Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Days||Standard Error|Mean
834944|NCT01281839|Secondary|The Percentage of Participants With Viral Breakthrough at Different Time Points|The table below shows the percentage of participants at different time points with viral breakthrough, defined as a confirmed increase of greater than 1 log10 IU/mL in plasma HCV ribonucleic acid (RNA) level from the lowest level reached (ie, lowest value measured in between baseline and current value), or a confirmed plasma HCV RNA level of greater than 100 IU/mL in participants whose plasma HCV RNA had previously been below the limit of quantification (25 IU/mL detectable) or undetectable (<25 IU/mL undetectable).|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of Participants|||Number
834945|NCT01281839|Secondary|Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <1000 IU/mL|The table below shows mean time in days to reach HCV RNA levels <1000 IU/mL.|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Days||95% Confidence Interval|Median
834946|NCT01281839|Secondary|Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <100 IU/mL|The table below shows mean time in days to reach HCV RNA levels <100 IU/mL.|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Days||95% Confidence Interval|Median
834947|NCT01281839|Secondary|Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable or Detectable|The table below shows mean time in days to reach HCV RNA levels <25 IU/mL undetectable or detectable.|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Days||95% Confidence Interval|Median
834948|NCT01281839|Secondary|Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable|The table below shows mean time in days to reach HCV RNA levels <25 IU/mL undetectable or detectable.|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Days||95% Confidence Interval|Median
834949|NCT01281839|Secondary|The Percentage of Participants With On-treatment Failure|The table below shows percentage of participants with on-treatment failure defined as confirmed detectable Hepatitis C virus ribonucleic acid levels at actual end of treatment.|Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of Participants|||Number
834950|NCT01281839|Secondary|The Percentage of Participants Who Completed All Study Treatment at Week 24 Because of the Treatment Duration Rule|The table below shows the percentage of participants in the TMC435 treatment group who met the treatment duration rule (ie, having hepatitis C virus [HCV] ribonucleic acid [RNA] levels <25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA levels at Week 12) and completed treatment with PegIFNα-2a and RBV for 24 weeks. Participants in the TMC435 treatment group not meeting RGT criteria and participants in the placebo group were treated with PegIFNα-2a and RBV treatment for 48 weeks.|Week 24|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of Participants|||Number
834951|NCT01281839|Secondary|The Percentage of Participants With Viral Relapse|The table below shows the percentage of participants with viral relapse, defined as having confirmed detectable plasma level of Hepatitis C virus (HCV) ribonucleic acid (RNA) during the follow-up period in participants with undetectable plasma HCV RNA (less than 25 IU/mL undetectable) at the end of treatment.|Up to Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of Participants|||Number
834952|NCT01281839|Secondary|The Percentage of Participants With Viral Breakthrough|The table below shows the percentage of participants with viral breakthrough, defined as a confirmed increase of greater than 1 log10 IU/mL in plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) level from the lowest level reached (ie, lowest value measured in between baseline and current value), or a confirmed plasma HCV RNA level of greater than 100 IU/mL in participants whose plasma HCV RNA had previously been below the limit of quantification (25 IU/mL detectable) or undetectable (<25 IU/mL undetectable).|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of Participants|||Number
834953|NCT01281839|Secondary|The Percentage of Participants With Partial Response|The table below shows the percentage of participants with partial response, defined as =>2 log10 reduction in Hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 compared to baseline, but not achieving undetectable HCV RNA while on treatment.|Week 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of Participants|||Number
834954|NCT01281839|Secondary|The Percentage of Participants With Null Response|The table below shows the percentage of participants with null response, defined as <2 log10 reduction in Hepatitis C virus ribonucleic acid at Week 12 compared to baseline.|Week 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of Participants|||Number
834955|NCT01281839|Secondary|Percentage of Participants With in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels >1000 IU/mL at Week 4|The table below shows the percentage of participants in each treatment group with HCV RNA levels >1000 IU/mL at Week 4.|Week 4|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of Participants|||Number
835002|NCT01282203|Secondary|Creatine Kinase Myocardial Isoenzyme (if Available)|Creatine kinase myocardial isoenzyme values measured within 24 hours of anesthesia were to be collected when available.|Within 24 hours after anesthesia|No data were available for the creatine kinase myocardial isoenzyme outcome measure.|||||
834956|NCT01281839|Secondary|The Percentage of Participants With <1 log10 Decrease in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) From Baseline at Week 4|The table below shows the percentage of participants in each treatment group with <1 log10 HCV RNA decrease at Week 4.|Week 4|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of Participants|||Number
834957|NCT01281839|Secondary|The Percentage of Participants Achieving a Extended Rapid Virologic Response (eRVR)|The table below shows the percentage of participants in each treatment group who had a eRVR, defined as having undetectable plasma Hepatitis C Virus ribonucleic acid levels at Week 4 and 12.|Week 4 and Week 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of Participants|||Number
834958|NCT01281839|Secondary|The Percentage of Participants Achieving a Complete Early Virologic Response (cEVR)|The table below shows the percentage of participants in each treatment group who had a cEVR, defined as having undetectable plasma Hepatitis C Virus ribonucleic acid levels at Week 12.|Week 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of Participants|||Number
834959|NCT01281839|Secondary|The Percentage of Participants Achieving a Early Virologic Response (EVR)|The table below shows the percentage of participants who achieved an EVR, defined as having a change from baseline in plasma Hepatitis C virus ribonucleic acid of greater than or equal to 2 log10 at Week 12.|Week 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of Participants|||Number
834960|NCT01281839|Secondary|The Percentage of Participants Achieving a Rapid Virologic Response (RVR)|The table below shows the percentage of participants in each treatment group who achieved a RVR, defined as having undetectable plasma Hepatitis C virus ribonucleic acid levels after receiving 4 weeks of treatment.|Week 4|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of Participants|||Number
834961|NCT01281839|Secondary|The Percentage of Participants With On-treatment Virologic Response at All Time Points|The table below shows the percentage of participants with HCV ribonucleic acid (RNA plasma levels below the limit of detection (ie, <25 IU/mL undetectable), the percentage of participants with a HCV RNA plasma level below the limit of quantification (ie, less than [<] 25 IU/mL detectable or undetectable), the percentage of participants with plasma levels of HCV RNA <100 IU/mL, the percentage of participants with virologic responses of a greater than or equal to 2 log10 change from baseline in plasma levels of HCV RNA.|Day 3, Week 1, Week 2, Week 8, Week 16, Week 20, Week 28, Week 36, and Week 42|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of Participants|||Number
834962|NCT01281839|Secondary|Actual Values of log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)|The table below shows actual values of log10 HCV RNA levels. From Week 4 onwards, most participants in TMC 435 150mg 12Wks PR24/48 group had plasma HCV RNA levels below the limit of detection of the HCV RNA assay.|Day 3, Week 1, Week 4, Week 12, Week 24, and Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||log10 IU/mL||Standard Error|Mean
834963|NCT01281839|Secondary|Change From Baseline in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)|The table below shows change from baseline in log10 HCV RNA levels.|Day 3, Week 1, Week 4, Week 12, Week 24, and Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||log10 IU/mL||Standard Error|Mean
834964|NCT01281839|Secondary|The Percentage of Participants Who Achieved a Sustained Virologic Response 4 Weeks After the Planned End of Treatment (SVR4)|The table below shows the percentage of participants in each treatment group who achieved a SVR4, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid levels 4 weeks after planned end of treatment.|Week 28 or Week 52|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of Participants|||Number
834965|NCT01281839|Secondary|The Percentage of Participants Who Achieved a Sustained Virologic Response 24 Weeks After the Planned End of Treatment (SVR24)|The table below shows the percentage of participants in each treatment group who achieved a SVR24, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid levels 24 weeks after planned end of treatment.|Week 48 or Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of Participants|||Number
834966|NCT01281839|Secondary|The Percentage of Participants Achieving a Sustained Virologic Response at Week 72 (SVRW72)|The table below shows the percentage of participants in each treatment group who achieved a SVRW72, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid levels at end of treatment (EOT) and at Week 72.|Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of Participants|||Number
834967|NCT01281839|Primary|The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12)|The table below shows the percentage of participants in each treatment group who achieved a SVR12, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid 12 weeks after planned end of treatment.|Week 36 or Week 60|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
834968|NCT01281865|Primary|Response Rate (CR + PR) Assessed by RECIST 1.1 (Phase II)||At 8 weeks|||participants|||Number
834969|NCT01281917|Secondary|Overall Survival|Length of time from enrollment until death.|Up to 60 months|||Months||95% Confidence Interval|Median
834970|NCT01281917|Secondary|Duration of Response|Duration of Response is how long a response to therapy is held before a subject has progressive disease.|Up to 60 months|||months||95% Confidence Interval|Median
834971|NCT01281917|Secondary|Tolerability of the Regimen|Tolerability of the regimen is measured by the number of subjects able to complete the therapy as planned.|Up to 36 months|||Participants|||Count of Participants
834975|NCT01281917|Primary|Overall Response Rate|The primary objective of this study is to determine whether Velcade in combination with temsirolimus provides benefit to subjects with relapsed or refractory B-cell non-Hodgkin lymphoma as assessed by overall response rate (ORR) to therapy. ORR is the sum of patients with a Complete Response and Partial Response to therapy. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete REsponse (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 60 months|||Percentage of participants||95% Confidence Interval|Median
834976|NCT01282086|Secondary|Correlation Between Anesthesiologists' Clinical Experience and Time to Extubation and Awakening|Anesthesiologists' length of clinical experience with general anesthesia and modern inhalation agents was collected. The influence of this clinical experience on anesthesia parameters was evaluated by calculating Spearman's correlation coefficient between the duration of clinical experience (exp) with inhalation (inh) anesthesia and Sevorane on the time to extubation and the time to awakening, respectively.|Every minute after anesthesia was stopped until the patient was extubated and until the patient responded to a verbal command.|All participants with available data at each time point were included in the analysis.||Spearman's correlation coefficient|||Number
834977|NCT01282086|Secondary|Correlation Between Anesthesiologists' Clinical Experience and Hemodynamic Parameters During Anesthesia|The anesthesiologists' length of clinical experience with Sevorane was collected. The influence of this experience on the changes in hemodynamic parameters during anesthesia with Sevorane was evaluated by calculating Spearman's correlation coefficient between the duration of clinical experience with Sevorane and the changes in blood pressure, mean arterial pressure, and heart rate between T0 (before anesthesia) and T1 (at the end of induction), T2 (at the end of surgical incision), T3 (at the end of extubation), T4 (1 hour after the operation), and the minimum and maximum values, respectively.|Before starting anesthesia to one hour after the operation|All participants with available data were included in the analysis. n=the number of participants with available data at given time point.||Spearman's correlation coefficient|||Number
834978|NCT01282086|Secondary|Creatine Kinase Myocardial Isoenzyme (if Available)|Creatine kinase myocardial isoenzyme (CK-MB) values measured within 24 hours of anesthesia were to be collected when available.|Within 24 hours after anesthesia|All participants with available data were included in the analysis.||U/L||Standard Deviation|Mean
834979|NCT01282086|Secondary|Cardiac Troponin (Troponin T) (if Available)|Troponin T values measured within 24 hours of anesthesia were to be collected when available. No data were reported for this outcome measure during the study.|Within 24 hours after anesthesia|No data were available for the cardiac troponin outcome measure.|||||
834980|NCT01282086|Secondary|Presence of Deviations in Electrocardiogram Assessments During Anesthesia|Electrocardiogram (ECG) assessments performed during induction of the anesthesia and maintenance were analyzed with respect to the presence of the following deviations: blockades (problems with heart electrical activity), extrasystoles (extra abnormal heart beats), arrhythmia (abnormal heart rate or rhythm), and myocardial ischemia (decreased blood flow to the heart).|During induction and maintenance of anesthesia on Day 1|All participants with valid data were included in the analysis.||participants|||Number
834981|NCT01282086|Secondary|Heart Rate|The heart rate of each patient was recorded at different time points from just before the start of anesthesia to one hour after the operation concluded.|Before starting anesthesia to one hour after the operation|All participants with available data were included in the analysis. n=the number of participants with available data at given time point.||beats per minute||Standard Deviation|Mean
834982|NCT01282086|Secondary|Mean Arterial Pressure|The mean arterial pressure of each patient was recorded at different time points from just before the start of anesthesia to one hour after the operation concluded.|Before starting anesthesia to one hour after the operation|All participants with available data were included in the analysis. n=the number of participants with available data at given time point.||mm Hg||Standard Deviation|Mean
834983|NCT01282086|Secondary|Diastolic Blood Pressure|The diastolic blood pressure of each patient was recorded at different time points from just before the start of anesthesia to one hour after the operation concluded.|Before starting anesthesia to one hour after the operation|All participants with available data were included in the analysis. n=the number of participants with available data at given time point.||mm Hg||Standard Deviation|Mean
834984|NCT01282086|Secondary|Systolic Blood Pressure|The systolic blood pressure of each patient was recorded at different time points from just before the start of anesthesia to one hour after the operation concluded.|Before starting anesthesia to one hour after the operation|All participants with available data were included in the analysis. n= the number of participants with available data at given time point.||mm Hg||Standard Deviation|Mean
834985|NCT01282086|Primary|Patients' Overall Impression of the Anesthesia With Sevorane|After awakening from anesthesia, patients were surveyed regarding their overall impression of anesthesia with Sevorane. Patients selected one of the following answers: excellent, positive, indifferent, or other.|Day 1|All participants with available data were included in the analysis.||participants|||Number
834986|NCT01282086|Primary|Anesthesiologists' Satisfaction With Using Sevorane for Induction and Maintenance Anesthesia|The anesthesiologist's overall satisfaction with the inhalation anesthesia with Sevorane for each patient was assessed by means of a numerical rating scale ranging from 0 (dissatisfied) to 10 (very satisfied).|Day 1|All participants with available data were included in the analysis.||units on a scale||Standard Deviation|Mean
834987|NCT01282086|Primary|Time to Extubation of Patients|Time to extubation was measured from the time anesthesia administration was stopped until tracheal extubation occurred.|Every minute after anesthesia was stopped until extubation occurred|All participants with available data were included in the analysis.||minutes||Standard Deviation|Mean
834988|NCT01282086|Primary|Time to Awakening of Patients|Measured from the time anesthesia administration was stopped until the patient responded to a verbal command.|Every minute after anesthesia was stopped until the patient responded to a verbal command|All participants with available data were included in the analysis.||minutes||Standard Deviation|Mean
834989|NCT01282086|Primary|Time to Loss of Consciousness of Patients Administered Anesthesia|Loss of consciousness was measured from the time the anesthetic was administered until loss of consciousness (loss of eyelash reflex) occurred.|Up to 16 minutes|All participants with available data were included in the analysis.||minutes||Standard Deviation|Mean
834990|NCT01282138|Primary|Change From Baseline in Patient-Assessed Ocular Itching, Conjunctival Allergen Provocation Test (CAPT), at 3 Hours|As assessed by the participant after 3 hours of CAPT. Ocular itching was graded on a 0-4 scale, where 0=none, 1=tickling sensation involving one or more corners of the eye, 2=all over tickling sensation; 3=moderate continuous itching with desire to rub; 4=severe itching with irresistible urge to rub.|Baseline, 3 hours|All enrolled participants||Units on a scale|Participants|Standard Error|Mean
834991|NCT01282138|Primary|Change From Baseline in Patient-Assessed Ocular Itching, Environmental Exposure Chamber (EEC), at 3 Hours|As assessed by the participant after 3 hours in the EEC. Ocular itching was graded on a 0-4 scale, where 0=none, 1=tickling sensation involving one or more corners of the eye, 2=all over tickling sensation; 3=moderate continuous itching with desire to rub; 4=severe itching with irresistible urge to rub.|Baseline, 3 hours|All enrolled participants||Units on a scale|Participants|Standard Error|Mean
834992|NCT01282164|Primary|Peak Cortisol Level During Adrenocorticotropin Hormone (ACTH) Stimulation Test|The peak cortisol level during ACTH stimulation test in 3 patients with adult onset hypothalamic-pituitary disease who were older than 65 years of age and could not under go insulin tolerance test (ITT).|one year|Peak cortisol level during ACTH stimulation test in three patients with hypothalamic-pituitary disorders who were older than 65 and could not undergo ITT based on the study protocol||ug/dL||Full Range|Median
834993|NCT01282164|Primary|Peak Cortisol Level in Adult Patients With Hypothalamic-pituitary Disorders and Three or More Pituitary Hormone Deficiency (PHD).|The peak cortisol level during Insulin Tolerance Test (ITT), fixed- dose glucagon stimulation test (GST) and weight-based GST in patients with adult onset hypothalamic-pituitary disease and three or more pituitary hormone deficiency (PHD) other than growth hormone (GH) deficiency.|one year|Peak cortisol level during Insulin Tolerance test, fixed-dose GST and weight-based GST in Patients with hypothalamic-pituitary disorders with three or more pituitary hormone deficiency other than GH deficiency. Two patients older than 65 years of age underwent adrenocorticotropin hormone (ACTH) stimulation test instead of ITT.||ug/dL||Full Range|Median
834994|NCT01282164|Primary|Peak Cortisol Level in Healthy Volunteers.|The peak cortisol levels during Insulin Tolerance Test (ITT), fixed- dose glucagon stimulation test (GST) and weight-based GST in healthy volunteers.|one year|Peak cortisol levels during Insulin Tolerance test, fixed-dose GST and weight-based GST in healthy volunteers||ug/dL||Full Range|Median
834995|NCT01282164|Primary|Peak Cortisol Level in Adult Patients With Hypothalamic-pituitary Disorders and 1-2 Pituitary Hormone Deficiency (PHD).|The peak cortisol level during Insulin Tolerance Test (ITT), fixed- dose glucagon stimulation test (GST) and weight-based GST in patients with adult onset hypothalamic-pituitary disease and 1-2 pituitary hormone deficiency (PHD) other than growth hormone (GH) deficiency.|one year|Peak cortisol levels during Insulin Tolerance test, fixed-dose GST and weight-based GST in Patients with hypothalamic-pituitary disorders and 1-2 pituitary hormone deficiency other than GH deficiency. One patient older than 65 years of age underwent ACTH stimulation test instead of ITT||ug/dL||Full Range|Median
834996|NCT01282164|Primary|Peak GH Level in Adult Patients With Hypothalamic-pituitary Disorders and Three or More Pituitary Hormone Deficiency (PHD).|The peak growth hormone (GH) during Insulin Tolerance Test (ITT), fixed- dose glucagon stimulation test (GST) and weight-based GST in patients with adult onset hypothalamic-pituitary disease with three or more pituitary hormone deficiency (PHD) other than growth hormone (GH) deficiency.|one year|Peak GH levels during Insulin Tolerance test, fixed-dose GST and weight-based GST in Patients with hypothalamic-pituitary disorders with three or more pituitary hormone deficiency other than GH deficiency. Two patients older than 65 years underwent adrenocorticotropin hormone (ACTH) stimulation test instead of ITT.||ng/mL||Full Range|Median
834997|NCT01282164|Primary|Peak Growth Hormone (GH) Level in Healthy Volunteers|The peak growth hormone (GH) during Insulin Tolerance Test (ITT), fixed- dose glucagon stimulation test (GST) and weight-based GST in healthy volunteers|one year|||ng/mL||Full Range|Median
834998|NCT01282164|Primary|Peak GH Level in Adult Patients With Hypothalamic-pituitary Disorders and 1-2 Pituitary Hormone Deficiency (PHD).|The peak growth hormone (GH) during Insulin Tolerance Test (ITT), fixed- dose glucagon stimulation test (GST) and weight-based GST in patients with adult onset hypothalamic-pituitary disease and 1-2 pituitary hormone deficiency (PHD) other than growth hormone (GH) deficiency.|one year|Peak GH levels during Insulin Tolerance test, fixed-dose GST and weight-based GST in Patients with hypothalamic-pituitary disorders and 1-2 pituitary hormone deficiency other than GH deficiency. One patient older than 65 years underwent adrenocorticotropin hormone (ACTH) stimulation test instead of ITT.||ng/mL||Full Range|Median
834999|NCT01282203|Secondary|Anesthesiologists' Duration of Clinical Experience With Anesthesia|Mean number of years of participating anesthesiologists' clinical experience with general anesthesia, with modern inhalation agents, and with Sevorane. (See Outcome Measures 13 and 14 for correlated data.)|Baseline|Number of anesthesiologists participating in study.||years||Standard Deviation|Mean
835000|NCT01282203|Secondary|Correlation Between Anesthesiologists' Clinical Experience and Time to Extubation and Awakening|Anesthesiologists’ length of clinical experience with general anesthesia and modern inhalation agents was collected (see Outcome Measure 15). The influence of this clinical experience on anesthesia parameters was evaluated by calculating Spearman's correlation coefficient between the duration of clinical experience with inhalation anesthesia and Sevorane on the time to extubation and the time to awakening, respectively.|Every minute after anesthesia was stopped until the patient was extubated and until the patient responded to a verbal command|All participants with available data at each time point were included in the analysis.||Spearman's correlation coefficient|||Number
835001|NCT01282203|Secondary|Correlation Between Anesthesiologists' Clinical Experience and Hemodynamic Parameters During Anesthesia|The anesthesiologists' length of clinical experience with Sevorane was collected (see Outcome Measure 15). The influence of this experience on the changes in hemodynamic parameters during anesthesia with Sevorane was evaluated by calculating Spearman's correlation coefficient between the duration of clinical experience with Sevorane and the changes in blood pressure, mean arterial pressure, and heart rate between T0 (before anesthesia) and T1 (at the end of induction), T2 (at the end of surgical incision), T3 (at the end of extubation), T4 ( 1 hour after the surgery), and the minimum and maximum values, respectively.|Before starting anesthesia to one hour after the surgery|All participants with available data at each time point were included in the analysis.||Spearman's correlation coefficient|||Number
835004|NCT01282203|Secondary|Presence of Deviations in Electrocardiogram Assessments During Anesthesia|Electrocardiogram (ECG) assessments performed during induction of the anesthesia and maintenance were analyzed with respect to the presence of the following deviations: Blockades (problems with heart electrical activity), extrasystoles (extra abnormal heart beats), arrhythmia (abnormal heart rate or rhythm), and myocardial ischemia (decreased blood flow to the heart).|During induction and maintenance of anesthesia|All participants with valid data were included in the analysis.||Participants|||Number
835005|NCT01282203|Secondary|Heart Rate|The heart rate of each patient was recorded at different time points from just before the start of anesthesia to one hour after the surgery concluded.|Before starting anesthesia to one hour after the surgery|All participants with available data were included in the analysis.||beats per minute||Standard Deviation|Mean
835006|NCT01282203|Secondary|Mean Arterial Pressure|The mean arterial pressure of each patient was recorded at different time points from just before the start of anesthesia to one hour after the surgery concluded.|Before starting anesthesia to one hour after the surgery|All participants with available data were included in the analysis.||mm Hg||Standard Deviation|Mean
835007|NCT01282203|Secondary|Diastolic Blood Pressure|The diastolic blood pressure of each patient was recorded at different time points from just before the start of anesthesia to one hour after the surgery concluded.|Before starting anesthesia to one hour after the surgery|All participants with available data were included in the analysis.||mm Hg||Standard Deviation|Mean
835008|NCT01282203|Secondary|Systolic Blood Pressure|The systolic blood pressure of each patient was recorded at different time points from just before the start of anesthesia to one hour after the surgery concluded.|Before starting anesthesia to one hour after the surgery|All participants with available data were included in the analysis.||mm Hg||Standard Deviation|Mean
835009|NCT01282203|Primary|Patients' Overall Impression of Anesthesia With Sevorane|After awakening from anesthesia, patients were surveyed regarding their overall impression of anesthesia with Sevorane. Patients selected one of the following answers: Excellent, positive, indifferent, or other.|Day 1|All participants with available data were included in the analysis.||Participants|||Number
835010|NCT01282203|Primary|Anesthesiologists' Satisfaction With Using Sevorane for Induction and Maintenance Anesthesia|The overall satisfaction of the anesthesiologist with the inhalation anesthesia with Sevorane for each patient was assessed by means of a numerical rating scale ranging from 0 (dissatisfied) to 10 (very satisfied).|Day 1|All participants with available data were included in the analysis.||units on a scale||Standard Deviation|Mean
835011|NCT01282203|Primary|Time to Extubation of Patients|Time to extubation was measured from the time anesthesia administration was stopped until tracheal extubation occurred.|Every minute after anesthesia was stopped until extubation occurred|All participants with available data were included in the analysis.||Minutes||Standard Deviation|Mean
835012|NCT01282203|Primary|Time to Awakening of Patients|Measured from the time anesthesia administration was stopped until the patient responded to a verbal command.|Every minute after anesthesia was stopped until the patient responded to a verbal command.|All participants with available data were included in the analysis.||Minutes||Standard Deviation|Mean
835013|NCT01282203|Primary|Time to Loss of Consciousness of Patients Administered Anesthesia|Loss of consciousness was measured from the time the anesthetic was administered until loss of consciousness (loss of eyelash reflex) occurred.|Up to 10 minutes|All participants with available data were included in the analysis.||Minutes||Standard Deviation|Mean
835014|NCT01282229|Secondary|Discomfort|Subjects recorded in a diary discomfort on a 10 point visual analog scale daily for the week following treatment. Subjects provided an estimate for each of the four treated quadrants. Zero (0) represents no pain or discomfort and ten (10) represents severe pain and/or discomfort. For each subject discomfort scores on each day from Day 1 to Day 7 were summed. Medians and ranges for each treatment are recorded. The total score could range from 0 to 70.|1-7 days|Subjects with missing data (e.g., missing diary entries) are not included in the analysis.||sum of units on a scale|Participants|Full Range|Median
835015|NCT01282229|Secondary|Change in Gingival Index|The gingival index is a 0-4 unit scale that the examiner uses to estimate the amount of edema and erythema at 2 locations (lingual and buccal) for every tooth in the quadrant. Zero (0) represents no redness and swelling and four (4) represents severe redness and swelling. Negative numbers are a decrease in in examiner estimate of erythema and edema and represent an improvement in clinical outcome.|Baseline, 6, 12 months|||units on a scale from 0-4|Participants|Standard Deviation|Mean
835016|NCT01282229|Secondary|Change in Bleeding on Probing (BOP)|"Percent of pockets within a quadrant that changed from baseline to 6 or 12 months. Negative numbers are a decrease in bleeding on probing which represents clinical improvement.
Each quadrant within the patient represents one of four treatments, the unit of analysis. Pockets are replications within treatments and vary in number among quadrants."|Baseline, 6, 12 months|||percentage of pockets that bled|Participants|Standard Deviation|Mean
835017|NCT01282229|Secondary|Change in Probing Depth (PD)|Positive numbers indicate average decrease in probing depth (improvement).|Baseline, 6, 12 months|||mm|Participants|Standard Deviation|Mean
835018|NCT01282229|Primary|Gain in Clinical Attachment Level of Periodontal Tissues|Periodontitis causes loss of attachment of the tooth root to the surrounding bone. Change in Clinical Attachment Level (CAL) estimates the number of mm's of reattachment gained as a result of the treatment.|Baseline, 6, 12 months|5-6 mm baseline PD partition had a different sample size than the 7+mm partition.||mm|Participants|Standard Deviation|Mean
835019|NCT01282242|Secondary|Number of Subjects With Symptomatic Cerebral Edema|Safety of IV rt-PA as evident by rates of symptomatic cerebral edema defined as brain edema with mass effect as the predominant cause of clinical deterioration.|Within 96 hours of tPA administration|||Participants|||Count of Participants
835020|NCT01282242|Primary|Number of Subjects With Symptomatic Intracerebral Hemorrhage|Safety of IV rt-PA as evident by rates of symptomatic ICH defined by an increase of 4 points or more on the NIHSS .|Within 7 days from tPA administration.|||Participants|||Count of Participants
835021|NCT01282294|Secondary|Time to Full Weight Bearing|The time from surgery to full weight bearing was assessed in days.|0 - 18 months|Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8). 3 patients never reached full weight bearing, and 1 dropped out before 6 weeks.||days||Full Range|Median
835022|NCT01282294|Secondary|Patient's Perceived Satisfaction|Patient's perceived satisfaction was scored on a 100mm visual analog scale (VAS). A score of zero indicated no satisfaction, while a score of 100 indicated completely satisfied.|6 months|"Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8).
Patient satisfaction was completed by 84 patients."||scores on a scale||Standard Deviation|Mean
835023|NCT01282294|Secondary|Pain by Visual Analog Scale (VAS)|Leg pain intensity was rated on a 100-mm visual analog scale (VAS). A score of zero indicated no pain at all, and 100 represented the worst possible pain.|6 weeks, 3, 6, 12 and 18 months post-operatively|Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8).||scores on a scale||Standard Deviation|Mean
835024|NCT01282294|Secondary|Likelihood to Develop a Non-union Assessed by Surgeon|The likelihood to develop a non-union was assessed by the surgeon on a scale from 0 to 100 (0 = almost nil, 100 = absolutely sure).|6 weeks, 3 and 6 months post-operatively|Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8).||scores on a scale||Standard Deviation|Mean
835025|NCT01282294|Secondary|Likelihood to Develop Wound Infection Assessed by Surgeon|The likelihood to develop a wound infection was assessed by the surgeon on a scale from 0 to 100 (0 = almost nil, 100 = absolutely sure).|6 weeks, 3 and 6 months post-operatively|Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8).||scores on a scale||Standard Deviation|Mean
835026|NCT01282294|Primary|Infection Adverse Events|"Infections at the site of ETN PROtect implantation were classified according to Center for Disease Control (CDC) definition into:
superficial incisional surgical site infection (SSI), affecting skin and subcutaneous tissue
deep incisional SSI, affecting deep soft tissue
organ/ space SSI (Osteomyelitis), affecting joint or bursa"|0 - 18 months|Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8).||number of events|||Number
835027|NCT01282294|Primary|Functional Outcome: WOMAC|"The Western Ontario and McMaster Universities Arthritis Index (WOMAC) questionnaire was administered at 3, 6, 12 and 18 months post-operatively to assess three dimensions: pain, disability and joint stiffness in the knee.
Each question is scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores are summed up, with a possible score range of 0-96. A higher score on the WOMAC indicate more functional limitations."|3, 6, 12 and 18 months post-operatively|Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8).||scores on a scale||Standard Deviation|Mean
835028|NCT01282294|Primary|Functional Outcome: IOWA Ankle Score|The Iowa Ankle Score was administered at baseline (retrospective assessment of pre-trauma condition) as well as at 3, 6, 12 and 18 months post-operatively to measures ankle function across four dimensions (function, freedom from pain, gait, range of motion) on a scale of 0-100, where 100 is assigned to full function.|Baseline, 3, 6, 12 and 18 months post-operatively|Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8).||scores on a scale||Standard Deviation|Mean
835029|NCT01282294|Secondary|Surgeon's Perceived Satisfaction|Surgeons’ perceived satisfaction was assessed on a scale from 0 to 100 (0 = very satisfied, 100 = disappointed).|6 weeks, 3 and 6 months post-operatively|Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8).||scores on a scale||Standard Deviation|Mean
835030|NCT01282294|Secondary|Evidence of Functional Bone Union According to Johnson Classification|"Functional bone union was assessed according to Johnson et al.*:
F0: motion at the fracture site; F1: level of pain is the same as before operation but able to perform all daily tasks of living; F2: occasional extremity pain and able to perform activities of daily living; F3: no pain and able to perform all activities except sports; F4: complete recovery, no recurrent episodes of pain, and unrestricted activity.
*Johnson EE, Urist MR, Finerman GA. Repair of segmental defects of the tibia with cancellous bone grafts augmented with human bone morphogenetic protein. A preliminary report. Clin.Orthop.Relat Res. 1988;249-57"|12 months|"Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8).
For the anatomic bone union at 12 months, data of 78 patients is available."||participants|||Number
835031|NCT01282294|Secondary|Evidence of Economic Bone Union According to Johnson Classification|"Economic bone union was assessed according to Johnson et al.*:
E0: complete invalid; E1: no gainful employment; E2: able to work but did not return to previous occupation; E3: returned to previous occupation on a part-time or limited status; E4: returned to previous occupation without restrictions.
*Johnson EE, Urist MR, Finerman GA. Repair of segmental defects of the tibia with cancellous bone grafts augmented with human bone morphogenetic protein. A preliminary report. Clin.Orthop.Relat Res. 1988;249-57"|12 months|"Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8).
For the anatomic bone union at 12 months, data of 78 patients is available."||participants|||Number
835075|NCT01282801|Primary|AUC0-inf of Venlafaxine.|Bioequivalence based on Venlafaxine AUC0-inf (area under the concentration-time curve from time zero to infinity).|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
835032|NCT01282294|Secondary|Evidence of Anatomic Bone Union According to Johnson Classification|"Anatomic bone union was assessed according to Johnson et al.*:
A0: pseudoarthrosis; A1: unilateral pseudoarthrosis; A2: insufficient unilateral bone mass; A3: contiguous union without hypertrophy; A4: solid union of the fracture site.
*Johnson EE, Urist MR, Finerman GA. Repair of segmental defects of the tibia with cancellous bone grafts augmented with human bone morphogenetic protein. A preliminary report. Clin.Orthop.Relat Res. 1988;249-57"|12 months|"Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8).
For the anatomic bone union at 12 months, data of 78 patients is available."||participants|||Number
835033|NCT01282294|Primary|Quality of Life: EQ-5D|The Euroqol Health Survey (EQ-5D, 3-level) was completed on five dimensions (mobility, self care, usual activities, pain/discomfort and anxiety/depression) to measure health-related quality of life on a scale from 0-1. A higher score indicates better quality of life.|3, 6, 12 and 18 months post-operatively|Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8).||scores on a scale||Standard Deviation|Mean
835034|NCT01282294|Primary|Quality of Life: SF-12 Mental Component Summary (MCS)|"The SF-12 short form health survey comprises 12 questions related to health and wellbeing over the prior four weeks. The responses to these 12 questions are entered into a standardized algorithm to provide summaries of physical and mental health (i.e., physical composite score [PCS] and mental composite score [MCS]). The summary scores are standardized and normalized such that a score of 50 for either the PCS or MCS corresponds to that of an average, healthy person. A score lower than 50 indicates poorer physical and mental health compared to an average, healthy person.
It was administered at 3, 6, 12 and 18 months post-operatively."|3, 6, 12 and 18 months post-operatively|Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8).||scores on a scale||Standard Deviation|Mean
835035|NCT01282294|Primary|Quality of Life: SF-12 Physical Component Summary (PCS)|"The Short Form (SF)-12 health survey comprises 12 questions related to health and wellbeing over the prior four weeks. The responses to these 12 questions are entered into a standardized algorithm to provide summaries of physical and mental health (i.e., physical composite score [PCS] and mental composite score [MCS]). The summary scores are standardized and normalized such that a score of 50 for either the PCS or MCS corresponds to that of an average, healthy person. A score lower than 50 indicates poorer physical and mental health compared to an average, healthy person.
It was administered at 3, 6, 12 and 18 months post-operatively."|3, 6, 12 and 18 months post-operatively|Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8).||scores on a scale||Standard Deviation|Mean
835036|NCT01282372|Secondary|Mean Sleep Disturbance Subscale Score|The Medical Outcome Study (MOS) sleep scale was a 12-item, participant-reported, non-disease-specific measure related to sleep that yielded 7 subscales (4-item sleep disturbance, 2-item sleep adequacy, 1-item quantity of sleep, 3-item somnolence, 1-item snoring, 1-item shortness of breath, and 9-item overall sleep problems index). Only sleep disturbance subscale was assessed by calculating the average of the 4-items with total score ranging from 0 to 100 (higher scores indicating greater sleep disturbance). Data are presented as mean score on a scale +/- standard deviation.|Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24|The analysis was performed using safety analysis set defined as all participants who received at least one dose of adalimumab.||Scores on a scale||Standard Deviation|Mean
835037|NCT01282372|Secondary|Mean Visual Analogue Scale (VAS) Score|The VAS score assessed by participants (pt) and physicians (ph) was used to determine the pain due to psoriatic arthritis in the past week. The level of pain was measured in millimeters (mm) on a 100 mm horizontal line. The score ranged from 0 (no pain) to 100 (severe pain). Data are presented as mean VAS score +/- standard deviation.|Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24|The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available VAS score at the study time points.||Scores on a scale||Standard Deviation|Mean
835038|NCT01282372|Secondary|Mean Plasma Concentrations of C-Reactive Protein (CRP)|Plasma concentrations were assessed to evaluate CRP, a marker of systemic inflammation that provided insights into the overall anti-inflammatory effect of rheumatologic therapies. Data are presented as mean CRP value in milligrams per liter (mg/L) ± standard deviation.|Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24|The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with evaluable data at the study time points.||mg/L||Standard Deviation|Mean
835039|NCT01282372|Secondary|Mean Erythrocyte Sedimentation Rate (ESR)|Plasma concentrations were assessed to evaluate ESR, a marker of systemic inflammation that provided insights into the overall anti-inflammatory effect of rheumatologic therapies. Data are presented as mean ESR value in millimeters per hour (mm/hr) ± standard deviation.|Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24|The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with evaluable data at the study time points.||mm/hr||Standard Deviation|Mean
835040|NCT01282372|Secondary|Percentage of Participants With Tender Joint Count (TJC) and Swollen Joint Count (SJC) Greater Than Zero|"Joints (68 or 66) were assessed by pressure and joint manipulation on physical examination for TJC or SJC, respectively. Both joint tenderness and swelling were classified as present (1), absent (0), replaced (9), or no assessment (NA). The total TJC or SJC was derived as the sum of the tender and swollen joints; the range for TJC and SJC were 0 - 68 and 0 - 66, respectively with higher scores indicated worse conditions. Data are presented as percentage of participants with TJC and SJC."|Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24|The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with evaluable data at the study time points.||Percentage of participants|||Number
835076|NCT01282801|Primary|AUC0-t of Venlafaxine.|Bioequivalence based on Venlafaxine AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
835041|NCT01282372|Secondary|Mean Psoriatic Arthritis Response Criteria (PsARC) Score|As the patient and physician global assessments were performed using a 0-100 VAS scale instead of the 5 point Likert scale, the PsARC score could not be calculated, although data on joint pain and swelling were collected. Hence, the psoriatic arthritis disease activity was evaluated by the percentage of patients with tender and swollen joints, acute phase reactants (ESR and CRP), and VAS Score (patient and physician). Data are reported under outcome measures 13 through 16.|Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24|The PsARC score was not assessed in this study.|||||
835042|NCT01282372|Secondary|Mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score|The BASDAI was a six question, participant-reported measure of overall disease activity that probed the level of fatigue, neck/back/hip pain, peripheral joint swelling and pain, localized tenderness, as well as morning stiffness severity and duration. The mean measurement (score) of questions 5 and 6 is added to the scores from questions 1 to 4 and divided by 5 to calculate the total BASDAI score. It was scored on a numerical rating scale that ranged from 0 (no symptoms) to 10 (severe symptoms), higher scores indicating severe disability due to AS disease. Data are presented as mean total BASDAI score +/- standard deviation.|Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24|The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available BASDAI score at the study time points.||Scores on a scale||Standard Deviation|Mean
835043|NCT01282372|Secondary|Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Score|The HAQ-DI was a participant-reported questionnaire that measured quality of life in terms of physical function of participants with rheumatoid arthritis. It consisted of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past seven days using the following response categories (score): without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). The scores on each task were summed and averaged to provide an overall score from 0 to 3, where 0-1 represented mild disability and 2-3 represented severe disability. Data are presented as mean HAQ-DI score +/- standard deviation.|Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24|The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available HAQ-DI score at the study time points.||Scores on a scale||Standard Deviation|Mean
835044|NCT01282372|Secondary|Mean Disease Activity Score 28 (DAS28)|The DAS28, a combined index that measured rheumatoid arthritis disease activity, was calculated based on: (1) the number of tender joints among 28 joints evaluated; (2) the number of swollen joints among 28 joints evaluated; (3) general health evaluated by a visual analog scale (VAS); (4) erythrocyte sedimentation rate (ESR); and (5) C-reactive protein (CRP). The DAS28 scores ranged from 0 (no disease activity) to 10 (maximal disease activity); decrease in DAS28 scores indicate improvement of disease. The DAS28 score less than or equal to 2.6 is defined as clinical remission. Data are presented as mean DAS28 score +/- standard deviation.|Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24|The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available DAS28 score at the study time points.||Scores on a scale||Standard Deviation|Mean
835045|NCT01282372|Primary|Mean Change From Baseline in Overall Activity Impairment Due to Health Problem|The 'overall activity impairment due to health problem' was assessed using the WPAI-GHP questionnaire. WPAI-GHP is a six-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of rheumatoid diseases (RA, PsA, and AS). The 'overall activity impairment due to health problem' was calculated based on one item: (Q6) to what degree did the disease impair the ability to do regular activities in the past seven days from visit. The item was measured on a scale from 0 (no effect) to 10 (completely prevented from doing regular activities/working). The data was calculated using the formula Q6/10 and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.|Baseline (Day 1) and Month 24|The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available WPAI-GHP score at the study time points.||Impairment percentage||Standard Deviation|Mean
835046|NCT01282372|Secondary|Mean Change From Baseline in Overall Activity Impairment Due to Health Problem by Disease Subgroups|The 'overall activity impairment due to health problem' was assessed using the WPAI-GHP questionnaire. WPAI-GHP is a six-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of rheumatoid diseases (RA, PsA, and AS). The 'overall activity impairment due to health problem' was calculated based on one item: (Q6) to what degree did the disease impair the ability to do regular activities in the past seven days from visit. The item was measured on a scale from 0 (no effect) to 10 (completely prevented from doing regular activities/working). The data was calculated using the formula Q6/10 and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.|Baseline (Day 1) and Month 24|The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available WPAI-GHP score at the study time points.||Impairment percentage||Standard Deviation|Mean
835047|NCT01282372|Primary|Mean Change From Baseline in Overall Work Impairment Due to Health Problem|The 'overall work impairment due to health problem' was assessed using the WPAI-GHP questionnaire. WPAI-GHP is a six-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of rheumatoid diseases (RA, PsA, and AS). The 'overall work impairment due to health problem' was calculated based on three items: (Q2) the number of hours missed from work due to health problems in the past seven days from visit; (Q4) the number of actual work hours in the past seven days from visit; and (Q5) to what degree did the disease impair the productivity while working past seven days from visit). The data was calculated using the formula Q2/(Q2+Q4)+[(1-(Q2/(Q2+Q4))x(Q5/10)] and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.|Baseline (Day 1) and Month 24|The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available WPAI-GHP score at the study time points.||Impairment percentage||Standard Deviation|Mean
835077|NCT01282801|Primary|Cmax of Venlafaxine.|Bioequivalence based on Venlafaxine Cmax (maximum observed concentration of drug substance in plasma).|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
835048|NCT01282372|Secondary|Mean Change From Baseline in Overall Work Impairment Due to Health Problem by Disease Subgroups|The 'overall work impairment due to health problem' was assessed using the WPAI-GHP questionnaire. WPAI-GHP is a six-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of rheumatoid diseases (RA, PsA, and AS). The 'overall work impairment due to health problem' was calculated based on three items: (Q2) the number of hours missed from work due to health problems in the past seven days from visit; (Q4) the number of actual work hours in the past seven days from visit; and (Q5) to what degree did the disease impair the productivity while working past seven days from visit). The data was calculated using the formula Q2/(Q2+Q4)+[(1-(Q2/(Q2+Q4))x(Q5/10)] and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.|Baseline (Day 1) and Month 24|The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available WPAI-GHP score at the study time points.||Impairment percentage||Standard Deviation|Mean
835049|NCT01282372|Primary|Mean Change From Baseline in Impairment While Working Due to Health Problem|The 'impairment while working due to health problem' was assessed using the WPAI-GHP questionnaire. WPAI-GHP is a six-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of rheumatoid diseases (RA, PsA, and AS). The 'impairment while working due to health problem' was calculated based on one item: (Q5) to what degree did the disease impair the productivity while working in the past seven days from visit. The item was measured on a scale from 0 (no effect) to 10 (completely prevented from doing regular activities/ working). The data was calculated using the formula Q5/10 and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.|Baseline (Day 1) and Month 24|The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available WPAI-GHP score at the study time points.||Impairment percentage||Standard Deviation|Mean
835050|NCT01282372|Secondary|Mean Change From Baseline in Impairment While Working Due to Health Problem by Disease Subgroups|The 'impairment while working due to health problem' was assessed using the WPAI-GHP questionnaire. WPAI-GHP is a six-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of rheumatoid diseases (RA, PsA, and AS). The 'impairment while working due to health problem' was calculated based on one item: (Q5) to what degree did the disease impair the productivity while working in the past seven days from visit. The item was measured on a scale from 0 (no effect) to 10 (completely prevented from doing regular activities/ working). The data was calculated using the formula Q5/10 and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.|Baseline (Day 1) and Month 24|The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available WPAI-GHP score at the study time points.||Impairment percentage||Standard Deviation|Mean
835051|NCT01282372|Primary|Mean Change From Baseline in Work Time Missed Due to Health Problem|The 'work time missed due to health problem' was assessed using the Work Productivity and Activity Impairment-General Health Problem (WPAI-GHP) questionnaire. WPAI-GHP is a six-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of rheumatoid diseases (RA, PsA, and AS). The 'work time missed due to health problem' was calculated based on two items: (Q2) the number of hours missed from work due to health problems in the past seven days from visit and (Q4) the number of actual work hours in the past seven days from visit. The data was calculated using the formula Q2/(Q2+Q4) and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.|Baseline (Day 1) and Month 24|The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available WPAI-GHP score at the study time points.||Impairment percentage||Standard Deviation|Mean
835052|NCT01282372|Secondary|Mean Change From Baseline in Work Time Missed Due to Health Problem by Disease Subgroups|The 'work time missed due to health problem' was assessed using the WPAI-GHP questionnaire. WPAI-GHP is a six-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of rheumatoid diseases (RA, PsA, and AS). The 'work time missed due to health problem' was calculated based on two items: (Q2) the number of hours missed from work due to health problems in the past seven days from visit and (Q4) the number of actual work hours in the past seven days from visit. The data was calculated using the formula Q2/(Q2+Q4) and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.|Baseline (Day 1) and Month 24|The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available WPAI-GHP score at the study time points.||Impairment percentage||Standard Deviation|Mean
835053|NCT01282424|Secondary|Pharmacokinetic (PK) Parameter: AUClast|AUClast at Days 1 and 29 was analyzed. AUClast is defined as the concentration of drug from time zero to the last observable concentration|Predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose on Days 1 and 29|PK Analysis Set: Participants enrolled in the PK substudy were analyzed.||hours x ng/mL||Standard Deviation|Mean
835054|NCT01282424|Secondary|Pharmacokinetic (PK) Parameter: Tmax|Tmax at Days 1 and 29 was analyzed. Tmax is defined as the time of Cmax (the maximum concentration of drug).|Predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose on Days 1 and 29|PK Analysis Set||hours||Inter-Quartile Range|Mean
835055|NCT01282424|Secondary|Pharmacokinetic (PK) Parameter: Cmax|Cmax at Days 1 and 29 was analyzed. Cmax is defined as the maximum concentration of drug.|Predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose on Days 1 and 29|PK Analysis Set: Participants enrolled in the PK substudy were analyzed.||ng/mL||Standard Deviation|Mean
835056|NCT01282424|Secondary|Idelalisib Plasma Concentration||Predose and at 1.5 hours (± 5 minutes) postdose on Day 29|||ng/mL||Standard Deviation|Mean
835057|NCT01282424|Secondary|Study Drug Exposure|The average idelalisib exposure was summarized.|From enrollment until all subjects completed ≥ 24 weeks of evaluation (up to 24 months)|ITT Analysis Set||months||Standard Deviation|Mean
835058|NCT01282424|Secondary|Safety and Tolerability of Idelalisib Assessed as the Number of Participants Experiencing Adverse Events (AEs) or Abnormalities in Vital Signs, Laboratory Tests, or Electrocardiograms|"This composite endpoint measured the safety and tolerability profile of idelalisib. Clinically meaningful abnormalities in vital signs and electrocardiograms (ECG) were as determined by the investigator."|From enrollment until all subjects completed ≥ 24 weeks of evaluation (up to 24 months)|ITT Analysis Set||participants|||Number
835059|NCT01282424|Secondary|Change in Karnofsky Performance Status|The change in Karnofsky performance status was reported as the best (highest change score) and worst (lowest change score) change from baseline using the Karnofsky performance criteria. The Karnofsky score classifies patients according to their functional impairment. Scores are on a scale from 0-100, the lower the score, the worse the survival for most serious illnesses.|From enrollment until all subjects completed ≥ 24 weeks of evaluation (up to 24 months)|Participants in the ITT Analysis Set with available data were analyzed.||units on a scale||Standard Deviation|Mean
835060|NCT01282424|Secondary|Change in Health-related Quality of Life|"Change in health-related quality of life events were reported by participants using the Functional Assessment of Cancer Therapy: Lymphoma Subscale (FACT-LymS) assessment tool. Results are presented as the mean (SD) best change from baseline. The best change from baseline was defined as the highest change score (improvement) after baseline.
The FACT-LymS is on a scale from 0-60, with higher scores associated with a better quality of life. It incorporates values from 15 questions, each rated 0-4, related to study indications."|From enrollment until all subjects completed ≥ 24 weeks of evaluation (up to 24 months)|Participants in the ITT Analysis Set with available data were analyzed.||units on a scale||Standard Deviation|Mean
835061|NCT01282424|Secondary|Overall Survival|Overall survival (OS) was defined as the time interval from the start of idelalisib treatment to death from any cause.|From enrollment until all subjects completed ≥ 24 weeks of evaluation (up to 24 months)|ITT Analysis Set||months||95% Confidence Interval|Median
835062|NCT01282424|Secondary|Progression-Free Survival|Progression-free survival (PFS) was defined as the interval from the start of idelalisib treatment to the earlier of the first documentation of disease progression as assessed by the study IRC or death from any cause.|From enrollment until all subjects completed ≥ 24 weeks of evaluation (up to 24 months)|ITT Analysis Set||months||95% Confidence Interval|Median
835063|NCT01282424|Secondary|Time to Response|Time to response (TTR) was defined as the interval from the start of idelalisib treatment to the first documentation of CR or PR (or MR for participants with WM) as assessed by the study IRC.|From enrollment until all subjects completed ≥ 24 weeks of evaluation (up to 24 months)|Participants in the ITT Analysis Set who achieved a CR or PR (or MR for subjects with WM) were analyzed.||months||Inter-Quartile Range|Median
835064|NCT01282424|Secondary|Lymph Node Response Rate|Lymph node response (LNR) was defined as the percentage of participants who achieved a ≥ 50% decrease from baseline in the sum of the product of the perpendicular diameters (SPD) of measurable index lesions as assessed by the study IRC.|From enrollment until all subjects completed ≥ 24 weeks of evaluation (up to 24 months)|ITT Analysis Set||percentage of participants||95% Confidence Interval|Number
835065|NCT01282424|Secondary|Duration of Response|Duration of Response (DOR) was defined as the interval from the first documentation of CR or PR (or MR for participants with WM) to the earlier of the first documentation of disease progression as assessed by the study IRC or death from any cause.|From enrollment until all subjects completed ≥ 24 weeks of evaluation (up to 24 months)|Participants in the ITT Analysis Set who achieved a CR or PR (or MR for subjects with WM) were analyzed.||months||Inter-Quartile Range|Median
835066|NCT01282424|Primary|Overall Response Rate|"Overall response rate (ORR) was assessed based on the International Working Group Revised Response Criteria for Malignant Lymphoma (Cheson, 2007), and was defined as the proportion of subjects achieving a complete response (CR) or partial response (PR; or minor response [MR] for subjects with Waldenström macroglobulinemia [WM]) as assessed by the study independent review committee (IRC).
CR was defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease.
PR was defined as a ≥ 50% reduction in the sum of the products of the longest perpendicular diameters of all index lesions, with no new lesions.
For WM only, response was defined as a reduction in IgM of ≥ 50% decrease for PR, and ≥ 25% decrease for MR; plus any reduction in the sum of the products of the longest perpendicular diameters of all index lesions, with no new lesions or signs and symptoms of active disease (Owen, 2013)"|From enrollment until all subjects completed ≥ 24 weeks of evaluation (up to 24 months)|ITT Analysis Set: Enrolled participants who received at least one dose of study medication||percentage of participants||95% Confidence Interval|Number
835067|NCT01282476|Secondary|Toxicities|Evaluate safety of this combination in relapsed/refractory DLBCL patients Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening|1 year|||Participants|||Count of Participants
835068|NCT01282476|Secondary|Progression-free Survival Rate|Progression is defined by the Revised International Workshop Response Criteria (2007) (see reference in protocol section).|6 months|||percentage of participants||90% Confidence Interval|Number
835069|NCT01282476|Primary|Overall Response Rate|"Overall response rate is defined by the Revised International Workshop Response Criteria (2007) (see reference in protocol section).
Overall response (OR) = Complete response (CR) + Partial response (PR)"|1 year|||percentage of participants||90% Confidence Interval|Number
835070|NCT01282710|Primary|Comparison of SureCALL® and TOCO Detection of Contraction Events, as Compared to the IUPC|Contraction timing as measured by the SureCALL® and contraction timing as measured by the TOCO, both compared to the contraction timing as measured by the IUPC gold standard. The contraction timing values of SureCALL® and TOCO were then compared.|9 - 42 Minutes|||Seconds||Standard Deviation|Mean
835071|NCT01282723|Primary|Comparison of SureCALL® and TOCO Detection of Contraction Events, as Compared to the IUPC, as Identified by Readers|The presence of contractions measured by the SureCALL®, the presence of contractions measured by the TOCO, and the presence of contractions measured by the IUPC were determined by independent Readers. The Odds Ratio of SureCALL® contractions to IUPC contractions was calculated, and the Odd Ratio of TOCO contractions to IUPC contractions was calculated. Reader Correspondence was determined by a General Linear Mixed Model.|9 - 42 Minutes|||Odds Ratio||95% Confidence Interval|Number
835072|NCT01282801|Secondary|AUC0-inf of O-Desmethylvenlafaxine.|Informational comparison of AUC0-inf values for the metabolite O-Desmethylvenlafaxine.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
835073|NCT01282801|Secondary|AUC0-t of O-Desmethylvenlafaxine.|Informational comparison of AUC0-t values for the metabolite O-Desmethylvenlafaxine.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
835078|NCT01282814|Primary|AUC0-inf of Venlafaxine.|Bioequivalence based on Venlafaxine AUC0-inf (area under the concentration-time curve from time zero to infinity).|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
835079|NCT01282814|Primary|AUC0-t of Venlafaxine.|Bioequivalence based on Venlafaxine AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
835080|NCT01282814|Primary|Cmax of Venlafaxine.|Bioequivalence based on Venlafaxine Cmax (maximum observed concentration of drug substance in plasma).|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
835081|NCT01282866|Secondary|Hair Count|"The hair at the treatment area is counted at Baseline and 15 months following the last treatment.
Hair clearance is determined by the percentage of Hair left 15 months following the last treatment compared to the hair number at baseline."|15 month following last treatment|The number of participants who completed 15 months follow up was 23 out of 35.||percentage of hair clearance||Standard Deviation|Mean
835082|NCT01282866|Secondary|Level of Comfort Associated With Treatment||Each treatment||||||
835083|NCT01282866|Secondary|Treatment Time|The treatment time was measured for each participant on each and every visit. The result is presented as mean of all treatment time from all of the visits and all of the participants.|Each treatment|||minutes||Standard Deviation|Mean
835084|NCT01282866|Primary|Hair Count|"The hair at the treatment area is counted at Baseline and 6 months following the last treatment.
Hair clearance is determined by the percentage of Hair left 6 months following the last treatment compared to the hair number at baseline."|6 month following last treatment|||percentage of hair clearance||Standard Deviation|Mean
835085|NCT01283022|Primary|Maximum Plasma Concentration (Cmax) of Misoprostol up to 1 Hour Post Study Drug Removal|The timepoints over which the pharmacokinetic measurements were assessed, and deemed as accurate and appropriate, were as follows: 0 hours (baseline), 0.5,1, 2, 4, 6, 8, 10 and 14 hours after insertion of the study drug, immediately prior to removal of the study drug and 0.5 and 1 hour after removal of the study drug. The 10 hour and 14 hour blood samples were obtained if the subject still had the study drug in place at those timepoints.|From study drug insertion up to 1 hour post study drug removal|The pharmacokinetic (PK) analysis included all 24 subjects from the Intention-to-Treat (ITT) population.||pg/mL||Standard Deviation|Median
835086|NCT01283022|Secondary|Rate of Adverse Events.|All adverse events were rated by the Investigator as mild, moderate or severe and classified as having no relationship, possible relationship or a probable relationship to the study drug. These assessments were deemed as accurate and appropriate for the reporting of all serious and non serious adverse events.|From study drug administration to hospital discharge (approximately 48-72 hours).|The percentage of subjects with adverse events are presented for the Intrapartum (before delivery), postpartum (maternal) and neonatal periods.||percentage of participants|||Number
835087|NCT01283022|Primary|Time of Maximum Plasma Concentration (Tmax) of Misoprostol After Insertion|The timepoints over which the pharmacokinetic measurements were assessed, and deemed as accurate and appropriate, were as follows: 0 hours (baseline), 0.5,1, 2, 4, 6, 8, 10 and 14 hours after insertion of the study drug, immediately prior to removal of the study drug and 0.5 and 1 hour after removal of the study drug. The 10 hour and 14 hour blood samples were obtained if the subject still had the study drug in place at those timepoints.|From study drug insertion up to 1 hour post study drug removal.|The pharmacokinetic (PK) analysis included all 24 subjects from the Intention-to-Treat (ITT) population.||hours||Standard Deviation|Median
835088|NCT01283035|Secondary|Toxicities of Akt Inhibitor MK2206, as Assessed by the Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE v4.0)||Up to 3 years|Number of participants experiencing toxicities.||participants|||Number
835089|NCT01283035|Secondary|Duration of Progression-free Following Initiation of Therapy With Akt Inhibitor MK2206 in the Cohort of Patients Enrolled on This Study|Distributions will be estimated using Kaplan-Meier analysis.|Up to 3 years|Minimal activity was observed and patient accrual was slow. This analysis was not completed as the data was not collected.|||||
835090|NCT01283035|Secondary|Duration of Overall Survival Following Initiation of Therapy With Akt Inhibitor MK2206 in the Cohort of Patients Enrolled on This Study|Distributions will be estimated using Kaplan-Meier analysis.|Up to 3 years|Minimal activity was observed and patient accrual was slow. This analysis was not completed as the data was not collected.|||||
835091|NCT01283035|Secondary|Development of Feedback Loop Activation and Target Inhibition With Akt Inhibitor MK2206 Via Analysis of Pre-treatment and Post-treatment Biopsies in Select Patients Enrolled in the Trial||Up to 3 years|Minimal activity was observed and patient accrual was slow. This analysis was not completed as the data was not collected.|||||
835092|NCT01283035|Secondary|Association Between Select Biomarkers and Response to Akt Inhibitor MK2206 (as Assessed by Objective Tumor Response, Progression-free Survival, and Overall Survival)|The frequency of mutations in the PI3K/AKT and RAS pathways, copy number alterations, and PTEN loss and AKT expression as assessed by IHC will be tabulated. Associations between these markers with clinical outcome such as response rate and duration of PFS will be assessed.|Up to 3 years|Minimal activity was observed and patient accrual was slow. This analysis was not completed as the data was not collected.|||||
835093|NCT01283035|Primary|Efficacy (as Measured by Objective Response Rate) of Akt Inhibitor MK2206 in Patients With Recurrent High-grade Platinum-resistant Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer|"If 4 or more of the final set of 29 patients demonstrate a response, then the null hypothesis H0: =< 5% can be rejected in favor of the alternative hypothesis H1: >= 20% with an alpha of 0.05 and beta of 0.20 (i.e., 80% power).
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression"|Up to 3 years|Five patients started study treatment.||participants|||Number
835094|NCT01283139|Secondary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings Reported as TEAEs|The 12-lead ECG data were summarized and evaluated. Number of participants with clinically significant abnormal ECG findings as assessed by cardiologist were recorded and reported as TEAEs.|Day 1 up to Week 56|The safety population included all participants who received any investigational product.||participants|||Number
835095|NCT01283139|Secondary|Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)|Vital sign assessments included blood pressure, pulse rate, temperature, weight and respiratory rate. Vital signs abnormalities recorded as TEAEs were reported.|Day 1 up to Week 61|The safety population included all participants who received any investigational product.||participants|||Number
835096|NCT01283139|Secondary|Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)|Laboratory investigations included hematology, serum chemistries and urinalysis parameters. Participants with clinically significant abnormalities in these laboratory investigations recorded as TEAEs were reported.|Day 1 up to Week 61|The safety population included all participants who received any investigational product.||participants|||Number
835097|NCT01283139|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent defined as events present at baseline that worsened in intensity after administration of investigational product or events absent at baseline that emerged after administration of investigational product, for the period extending until the end of participant participation in the study.|Day 1 up to Week 74|The safety population included all participants who received any investigational product.||participants|||Number
835098|NCT01283139|Secondary|Percentage of Participants Who Achieved a Greater Than 3-Point Improvement in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale|FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant’s response to the questions (with the exception of 2 negatively stated), greater was the participant’s fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant’s response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score).|Day 365|"The mITT population included all randomized participants who received any investigational product and had a baseline primary efficacy measurement. Here, N signifies number of participants with a FACIT-fatigue score <49 at baseline."||percentage of participants|||Number
835099|NCT01283139|Secondary|Percentage of Participants With a Cutaneous Lupus Erythematosus Disease Activity and Severity Index (CLASI) Activity Score Greater Than or Equal to (>=) 10 at Baseline Who Achieved a >= 4-point Reduction|The CLASI consists of two scores, the first summarizes the activity of the disease while the second is a measure of the damage done by the disease. Activity is scored on the basis of erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and non-scarring alopecia. Damage is scored in terms of dyspigmentation and scarring, including scarring alopecia. The percentage of participants with a CLASI activity score >=10 at baseline who achieved a clinically significant (>=4-point) reduction at Day 365 were reported.|Day 365|"The mITT population included all randomized participants who received any investigational product and had a baseline primary efficacy measurement. Here, N signifies number of participants with a CLASI activity score >=10 at baseline."||percentage of participants|||Number
835100|NCT01283139|Secondary|Percentage of Participants on Greater Than or Equal to 10 mg/Day Oral Prednisone (or Equivalent) at Baseline Who Were Able to Reduce to Less Than or Equal to (<=) 7.5 mg/Day|Percentage of participants on >=10 mg/day oral corticosteroids (OCS) at baseline who were able to taper it to <=7.5 mg/day by Day 365 were recorded.|Day 365|"The mITT population included all randomized participants who received any investigational product and had a baseline primary efficacy measurement. Here, N signifies number of participants on >=10 mg/day oral prednisone (or equivalent) at baseline."||percentage of participants|||Number
835101|NCT01283139|Primary|Percentage of Participants Achieving a Positive Response in SRI (4) in 4-Gene Interferon Test High Participants|SRI (4) responder is defined as: 1) a reduction in baseline SLEDAI-2K disease activity score of >=4 points (with increased DNA binding item of SLEDAI-2K score based on the ANA Multi−Lyte® ANA−II Plus Test System); 2) no worsening in Physician Global Assessment (MDGA) (worsening is defined as an increase of >=0.3 from baseline on a 0-3 visual analogue scale) and 3) no worsening in BILAG-2004 (worsening is defined as at least 1 new ‘A’ score or 2 new ‘B’ scores on the BILAG-2004 compared with baseline).|Day 365|"The mITT population included all randomized participants who received any investigational product and had a baseline primary efficacy measurement. Here, N signifies number of participants with positive diagnostic test."||percentage of participants|||Number
835102|NCT01283139|Primary|Percentage of Participants Achieving a Response in Systemic Lupus Erythematosus Responder Index 4 (SRI [4])|SRI (4) responder is defined as: 1) a reduction in baseline Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) disease activity score of greater than or equal to (>=) 4 points (with increased deoxyribonucleic acid [DNA] binding item of SLEDAI-2K score based on the ANA Multi−Lyte® ANA−II Plus Test System); 2) no worsening in Physician Global Assessment (MDGA) (worsening is defined as an increase of >=0.3 from baseline on a 0-3 visual analogue scale) and 3) no worsening in British Isles Lupus Assessment Group (BILAG-2004) (worsening is defined as at least 1 new ‘A’ score or 2 new ‘B’ scores on the BILAG-2004 compared with baseline).|Day 365|The modified intent-to-treat (mITT) population included all randomized participants who received any investigational product and had a baseline primary efficacy measurement.||percentage of participants|||Number
835103|NCT01283152|Primary|Change in HE Grade at 24 Hours|Hepatic Encephalopathy Scoring Algorithm (HESA) at the 24 hour time point of when the subject was recruited. HESA ranges from 0 to 3, with higher numbers indicating a more severe grade of hepatic encephalopathy. Study will continue at every 24 hour time point until the subject achieves his or her baseline mental state and/or grade 0 based on the HESA|Baseline to 24 hours|All participants who completed the study||participants|||Number
835104|NCT01283152|Secondary|Hospital Duration/Length of Stay||From time of admission to time of discharge or death|||days||Standard Deviation|Mean
835105|NCT01283152|Primary|Number of Participants With an Improvement of 1 or More in HE Grade at 24 Hours|Hepatic Encephalopathy Scoring Algorithm (HESA) at the 24 hour time point of when the subject was recruited (HESA improvement by at least 1 grade). HESA ranges from 0 to 3, with higher numbers indicating a more severe grade of hepatic encephalopathy. Study will continue at every 24 hour time point until the subject achieves his or her baseline mental state and/or grade 0 based on the HESA|Baseline to 24 hours|All participants who completed the study||participants|||Number
835106|NCT01283282|Secondary|Inflammatory Marker CD40 Ligand|CD40 ligand levels were measured. The level of CD40 ligand were measured using the Flurokine MultiAnalyte profiling (MAP) Human Base Kit B.|Week 12|||pg/mL||Standard Error|Mean
835107|NCT01283282|Secondary|Inflammatory Marker High-sensitivity C-reactive Protein (hsCRP)|High-sensitivity C-reactive protein (hsCRP) was measured. The hsCRP levels were measured by Dade Behring nephelometry.|Week 12|||mg/L||Standard Error|Mean
835108|NCT01283282|Secondary|Oxidative Stress Markers|Oxidative stress was measured by using liquid chromatography to collect plasma cystine, cysteine, gluthione, and oxidized glutathione levels.|Week 12|||µM||Standard Error|Mean
835109|NCT01283282|Secondary|Pulse Wave Velocity (PWV)|PWV was measured between the carotid and femoral arteries using the SphygmoCor device. Pressure waveforms at the carotid and femoral arteries were acquired using EKG gating. Velocity (distance per time in seconds) was calculated using the foot-to-foot method and the distance between the sites was measured manually.|Week 12|||m/s||Standard Error|Mean
835110|NCT01283282|Primary|Endothelial Progenitor Cells (EPCs)|The circulating progenitor-enriched population of cells was measured by the expression of surface antigens using direct flow cytometry for CD34+, CD34+/CD133+, CD34+/ VEGF2R+ and CD34+/CD133+/VEGF2R+|Week 12|||cells/µL||Standard Error|Mean
835111|NCT01283282|Primary|Nitroglycerin-mediated Vasodilation|Nitroglycerin (NTG)-mediated vasodilation was measured after 0.4 mg of NTG was administered sublingually. Brachial artery images were obtained via ultrasound after three minutes of NTG administration. Measurements from the twelve frames will be averaged to calculate the percent change in diameter of the brachial artery from baseline to 12 weeks.|Baseline, Week 12|||percent change in diameter||Standard Error|Mean
835112|NCT01283282|Primary|Flow-mediated Dilation (FMD)|Flow-mediated dilation (FMD) collected by an ultrasound and is measured by the percent change in diameter of the brachial artery from baseline to 12 weeks.|Baseline, Week 12|||percent change in diameter||Standard Error|Mean
835113|NCT01283321|Secondary|Blood Loss||Operative period||||||
835114|NCT01283321|Secondary|Units of Platelets and Allogeneic Red Cells Transfused- During Surgery and up to 24 Hours After Surgery||Peri-operative period||||||
835115|NCT01283321|Secondary|Units of Fresh-frozen Plasma (FFP) Transfused-during Surgery and up to 24 Hours After Surgery||Peri-operative period||||||
835116|NCT01283321|Secondary|Proportion of Patients in the Fibrinogen Group in Whom Transfusion of Fresh Frozen Plasma or Platelet Concentrate is Required During or After Surgery||Operative period||||||
835117|NCT01283321|Primary|Bleeding Scores|Bleeding scores are scored on a four-point scale. A visual assessment of surgical field was performed by the senior surgical staff as follows: 0 = excellent hemostasis (dry field), 1 = mild bleeding (oozing), 2 = moderate bleeding (controllable with applied pressure), and 3 = severe bleeding (multiple diffuse bleeding sites). If the visual bleeding scale was 2 to 3, the subjects were randomly assigned to a study intervention using a closed envelope method.|intra-operatively and up to 24 hours postoperatively|||units on a scale||Standard Deviation|Mean
835118|NCT01283334|Secondary|Progression-free Survival (PFS)|Objective tumor responses were assessed every 2 cycles of chemotherapy with computed tomography or positron emission tomography/ computed tomography scans in accordance with Response Evaluation Criteria In Solid Tumors (RECIST) criteria.|The time of PFS was calculated as the time from study enrollment to the disease progression date, death date, or last contact, whichever came first, up to 25 months|||months||Full Range|Median
835119|NCT01283334|Primary|To Measure the Safety and Clinical Effectiveness of the Combination of Carboplatin, Cetuximab and RAD001 in Patients With Advanced (Recurrent or Metastatic) Head and Neck Cancer|This phase 1 clinical trial used a standard 3 + 3 design. Four dose levels of everolimus were planned to be evaluated, and the standard 3 + 3 design with dose de-escalation was used in the trial. Namely, 3 patients were assigned to starting dose level 1. If no dose-limiting toxicity (DLT) was observed, the trial proceeded to the next dose level, and another cohort of 3 patients was enrolled. If at least 2 of the 3 patients experienced at least 1 DLT, then the dose level decreased; otherwise, if only 1 patient experienced DLT, then 3 more patients were enrolled at the same dose level. If none of the 3 additional patients experienced DLT, the dose was escalated; otherwise, the dose level decreased. Dose reduction continued until a dose level was reached at which 6 patients had been treated and at most 1 DLT was observed.|Within the first 21 days of therapy|||participants|||Number
835120|NCT01270659|Secondary|Number of Participants Experiencing Any Adverse Events|Occurrence of any adverse event.|Full 2 hours of the study period|||Participants|||Count of Participants
835121|NCT01270659|Secondary|Nausea Level|"Subjects' nausea level was recorded to determine how fentanyl buccal tablet compares to standard therapy in causing nausea. Treatment induced nausea and severity of nausea level was assessed.
Nausea was assessed by a 10-point verbally administered scale. Patients rated their degree of nausea on a scale of 0 (no nausea) to 10 (worst nausea).
At the beginning of the study, literature review found relatively little evidence guiding objective means to rate nausea, but there was some precedent for this approach (Warden C. Prehospital use of ondansetron reduces nausea and episodes of vomiting in adults and children over 12 years old [abstract]. Prehosp Emerg Care. 2007;11:132)."|every 5 minutes for the first 60 minutes|||Participants|||Count of Participants
835122|NCT01270659|Primary|Median Time to Significant Analgesia (at Least 2 Units Decrease in Pain Level)|Median time (in minutes) to 2 units decrease in pain level after drug administration. Patients were asked to rate their pain at every 5 minutes intervals from 0 to 60 minutes post drug administration. The 10-point verbally administered numeric pain rating scale (NPRS) was used to have patients rate their level of pain on a scale of 0 (no pain) to 10 (worst pain ever).|60 minutes|||minutes||95% Confidence Interval|Median
835186|NCT01270958|Primary|Alanine Aminotransferase (ALT) Value at Baseline and After Treatment Completion|ALT is a liver enzyme that plays a role in protein metabolism. Abnormally high blood levels of ALT are a sign of liver inflammation or damage from infection or drugs. Normal range: <=40 U/L.|Baseline and treatment completion (up to Week 6)|ITT Population||U/L||Standard Deviation|Mean
835123|NCT01270711|Primary|Prevalence of Valvular Fibrosis|Prevalence of valvular fibrosis was calculated as number of participants with documented valvulopathy during cabergoline treatment divided by number of participants with at least 1 echocardiography examination. Percentage of participants with valvular fibrosis are reported.|Baseline (Week 1) up to Week 339|Study population included all participants who were recruited from specialized clinical centers in Italy and treated with cabergoline for Parkinson’s disease during the study period.||percentage of participants|||Number
835124|NCT01270711|Primary|Incidence of Valvular Fibrosis|Incidence of valvular fibrosis was calculated as number of participants with documented valvulopathy during cabergoline treatment and absence of any valve damage at baseline divided by number of participants without any valve damage at baseline and at least 1 additional echocardiography examination during follow-up while on cabergoline treatment. Percentage of participants with valvular fibrosis are reported.|Baseline (Week 1) up to Week 339|Study population:all participants recruited from specialized clinical centers in Italy and treated with cabergoline for Parkinson’s disease during study period.||percentage of participants|||Number
835125|NCT01270711|Primary|Total Number of Echocardiography Examinations in Cabergoline Users|The CHMP recommended that the prescribing information for cabergoline should be updated to include: a warning stating that participant must be monitored for signs of cardiac valve fibrosis with echocardiography before treatment is started and regularly (every 6 months) during treatment. To evaluate effectiveness with the new prescription guidelines, it was assessed whether cabergoline users were monitored by echocardiography.|Baseline (Week 1) up to Week 339|Study population included all participants who were recruited from specialized clinical centers in Italy and treated with cabergoline for Parkinson’s disease during the study period.||echocardiography examinations|||Number
835126|NCT01270711|Primary|Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 6|The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.|Year 6 (Year 2011)|Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||percentage of prescriptions|||Number
835127|NCT01270711|Primary|Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 5|The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.|Year 5 (Year 2010)|Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||percentage of prescriptions|||Number
835128|NCT01270711|Primary|Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 4|The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.|Year 4 (Year 2009)|Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||percentage of prescriptions|||Number
835129|NCT01270711|Primary|Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 3|The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.|Year 3 (Year 2008)|Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||percentage of prescriptions|||Number
835130|NCT01270711|Primary|Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 2|The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.|Year 2 (Year 2007)|Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||percentage of prescriptions|||Number
835131|NCT01270711|Primary|Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 1|The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.|Year 1 (Year 2006)|Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||percentage of prescriptions|||Number
835140|NCT01270711|Primary|Number of Cabergoline Prescriptions by Database and Indication: Year 4|Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.|Year 4 (Year 2009)|Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||prescriptions|||Number
835245|NCT01277159|Primary|Time it Takes for Nerve Block to Wear Off|Does adding dexamethasone and / or buprenorphine prolong the analgesia provided by a popliteal fossa nerve block?|up to 72 hours|||hours||Standard Deviation|Mean
835132|NCT01270711|Primary|Percentage of Second-line Prescriptions of Cabergoline for Parkinson’s Disease Indications: Year 6|Changes to the Summary of Product Characteristics (SPC) in April 2007 included that the cabergoline should be used for Parkinson’s disease only in participants who have already taken or cannot take other treatments, that is as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline is considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.|Year 6 (Year 2011)|Study population: participants registered in one of databases and were treated with cabergoline during study period. Data not reported for IPCI and PHARMO databases because no information was retrieved for second-line prescriptions of cabergoline for Parkinson’s disease. ‘N’ (number of participants analyzed)=participants evaluable for this measure.||percentage of prescriptions|||Number
835133|NCT01270711|Primary|Percentage of Second-line Prescriptions of Cabergoline for Parkinson’s Disease Indications: Year 5|Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson’s disease only in participants who had already taken or cannot take other treatments, which was as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.|Year 5 (Year 2010)|Study population: participants registered in one of databases and were treated with cabergoline during study period. Data not reported for IPCI and PHARMO databases because no information was retrieved for second-line prescriptions of cabergoline for Parkinson’s disease. ‘N’ (number of participants analyzed)=participants evaluable for this measure.||percentage of prescriptions|||Number
835134|NCT01270711|Primary|Percentage of Second-line Prescriptions of Cabergoline for Parkinson’s Disease Indications: Year 4|Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson’s disease only in participants who had already taken or cannot take other treatments, which was as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.|Year 4 (Year 2009)|Study population: participants registered in one of databases and were treated with cabergoline during study period. Data not reported for IPCI and PHARMO databases because no information was retrieved for second-line prescriptions of cabergoline for Parkinson’s disease. ‘N’ (number of participants analyzed)=participants evaluable for this measure.||percentage of prescriptions|||Number
835135|NCT01270711|Primary|Percentage of Second-line Prescriptions of Cabergoline for Parkinson’s Disease Indications: Year 3|Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson’s disease only in participants who had already taken or cannot take other treatments, which was as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.|Year 3 (Year 2008)|Study population: participants registered in one of databases and were treated with cabergoline during study period. Data not reported for IPCI and PHARMO databases because no information was retrieved for second-line prescriptions of cabergoline for Parkinson’s disease. ‘N’ (number of participants analyzed)=participants evaluable for this measure.||percentage of prescriptions|||Number
835136|NCT01270711|Primary|Percentage of Second-line Prescriptions of Cabergoline for Parkinson’s Disease Indications: Year 2|Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson’s disease only in participants who had already taken or cannot take other treatments, which was as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.|Year 2 (Year 2007)|Study population: participants registered in one of databases and were treated with cabergoline during study period. Data not reported for IPCI and PHARMO databases because no information was retrieved for second-line prescriptions of cabergoline for Parkinson’s disease. ‘N’ (number of participants analyzed)=participants evaluable for this measure.||percentage of prescriptions|||Number
835137|NCT01270711|Primary|Percentage of Second-line Prescriptions of Cabergoline for Parkinson’s Disease Indications: Year 1|Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson’s disease only in participants who had already taken or cannot take other treatments, which was as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.|Year 1 (Year 2006)|Study population: participants registered in one of databases and were treated with cabergoline during study period. Data not reported for IPCI and PHARMO databases because no information was retrieved for second-line prescriptions of cabergoline for Parkinson’s disease. ‘N’ (number of participants analyzed)=participants evaluable for this measure.||percentage of prescriptions|||Number
835138|NCT01270711|Primary|Number of Cabergoline Prescriptions by Database and Indication: Year 6|Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.|Year 6 (Year 2011)|Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||prescriptions|||Number
835139|NCT01270711|Primary|Number of Cabergoline Prescriptions by Database and Indication: Year 5|Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.|Year 5 (Year 2010)|Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||prescriptions|||Number
835141|NCT01270711|Primary|Number of Cabergoline Prescriptions by Database and Indication: Year 3|Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.|Year 3 (Year 2008)|Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||prescriptions|||Number
835142|NCT01270711|Primary|Number of Cabergoline Prescriptions by Database and Indication: Year 2|Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.|Year 2 (Year 2007)|Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||prescriptions|||Number
835143|NCT01270711|Primary|Number of Cabergoline Prescriptions by Database and Indication: Year 1|Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.|Year 1 (Year 2006)|Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||prescriptions|||Number
835144|NCT01270802|Secondary|Change in Serum Levels of Vitamin D|Change in serum levels of 24-OH-vitamin D provide a measure of the amount of change in vitamin D in the body|Baseline and 24 weeks|||ng/mL||Standard Deviation|Mean
835145|NCT01270802|Primary|Change in Flow-mediated Dilation (FMD) of the Brachial Artery|Change in FMD is a measure of change in endothelial function|Baseline and 24 weeks|In the Switch to tenofovir/emtricitabine plus raltegravir arm, two FMD measurements at 24 weeks were removed from the analysis due to poor quality imaging.||% change from baseline||Standard Deviation|Mean
835146|NCT01270828|Secondary|Percentage of Participants With Suicidal Behaviour/Ideation|Percentage of participants with suicidal behavior/ideation were noted as Baseline, Weeks 6, 11, 15, 19 and 20.|Baseline, Weeks 6, 11, 15, 19 and 20|The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.||Percentage of participants|||Number
835147|NCT01270828|Secondary|Number of Participants With Adverse Events|"An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. A serious adverse event is any untoward medical occurrence at any dose that: Results in death; Is life-threatening (immediate risk of death); Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); or Results in congenital anomaly/birth defect. The study physician used the adjective severe to those AEs that interfere significantly with participant's usual function."|Baseline to Week 20|"The SB Analysis Set (SBAS) consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication; The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase.
Both SBAS and FAS were included in this analysis."||Participants|||Number
835148|NCT01270828|Secondary|Percentage of Participants With Benefit From Treatment, Satisfaction With Treatment and Willingness to Continue Treatement (BSW)|The BSW is administered by the study physician or designated site personnel and consists of three single item measures designed to capture the patient's perception of the effect of treatment in terms of the relative benefit, their satisfaction, and their intention or willingness to continue on therapy.|Week 19|The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.||Percentage of participants|||Number
835149|NCT01270828|Secondary|Change in the Brief Pain Inventory (BPI-sf)|The BPI sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. The BPI sf consists of 5 questions. Questions 1, 2, 3, and 4 measure pain on an 11 point scale from 0 (no pain) to 10 (worst pain possible). Question 5 consists of 7 item subsets which measure the level of interference of pain on daily functions on an 11 point scale from 0 (Does not interfere) to 10 (Completely interferes).|Week 19|The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.||Units on a scale||Standard Error|Least Squares Mean
835150|NCT01270828|Secondary|Change in Hospital Anxiety and Depression Scales (HADS)|The HADS is a self administered questionnaire that was designed to screen for the presence of a mood disorder in medically ill patients. To distinguish psychiatric presentations from physical illness, the items focus on subjective disturbance of mood rather than physical signs. The HADS contains 14 items rated on 4 point Likert type scales. Two subscales assess depression and anxiety. Each subscale consists of 7 statements, rated on a scale of 0 to 3 (0 = No anxiety or depression, to 3 = Severe feelings of anxiety or depression). Separate scores are calculated for each subscale ranging from 0 to 21. Higher scores denote greater severity of depression or anxiety|Week 19|The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.||Units on a scale||Standard Error|Least Squares Mean
835151|NCT01270828|Secondary|Change in Mean Daily Sleep Interference Scores|The pain related sleep interference item rating scale is scored on an 11 point numeric rating scale (NRS Sleep). It is self administered by the subject in order to rate how pain has interfered with their sleep during the past 24 hours, ranging from 0 (pain does not interfere with sleep) to 10 (completely interferes (unable to sleep due to pain)). Participants are to describe how their pain has interfered with their sleep during the past 24 hours by choosing the appropriate number on the numeric rating scale.|Week 19|The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.||Units on a scale||Standard Error|Least Squares Mean
835183|NCT01270958|Primary|Total Protein Value at Baseline and After Treatment Completion|A total protein assay measures the amount of proteins found in the plasma. Normal range: 65-82 g/L.|Baseline and treatment completion (up to Week 6)|ITT Population||g/L||Standard Deviation|Mean
835152|NCT01270828|Secondary|Change in the Short Form 36 Health Survey (SF-36)|The SF 36 is a self administered, validated questionnaire that measures each of the following 8 health aspects: Physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception over the past week. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) where, higher scores indicate a better health related quality of life.|Week 19|The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase. N in the below table refers to number of participants analyzed: 203 in Pregabalin DB CR group and 195 in Placebo DB group, unless otherwise specified.||Units on a scale||Standard Error|Least Squares Mean
835153|NCT01270828|Secondary|Percentage of Participants With Change in the Patient Global Impression of Change (PGIC) Score|The PGIC is a participant-rated instrument that has been used in chronic pain and fibromyalgia studies to rate change in a patient's overall status. This single item instrument uses a 7 point Likert scale, anchored by (1) very much improved, to (7) very much worse.|Week 19|The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.||Percentage of participants|||Number
835154|NCT01270828|Secondary|The MOS-SS-Optimal Sleep.|"The MOS-SS is a validated self administered questionnaire consisting of 12 items that assess key constructs of sleep. The scale has been found reliable and valid with good overall measurement properties. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9 item overall sleep problems index assessing sleep over the past week.
The optimal sleep score is a dichotomous 'Yes' or 'No' rating, where 'Yes' indicates optimal sleep (average 7-8 hours per night) and 'No' indicates not optimal sleep. The percentage of participants with optimal sleep is presented here."|Week 6 and Week 19|The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.||Percentage of participants|||Number
835155|NCT01270828|Secondary|Change in the MOS-SS-Quantity of Sleep.|"The MOS-SS is a validated self administered questionnaire consisting of 12 items that assess key constructs of sleep. The scale has been found reliable and valid with good overall measurement properties. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9 item overall sleep problems index assessing sleep over the past week.
The item Quantity of sleep of MOS-SS is presented here."|SB Baseline (BL) (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19|The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.||Hours||Standard Error|Least Squares Mean
835156|NCT01270828|Secondary|Change in the Medical Outcomes Study-Sleep Scale (MOS-SS).|The MOS-SS is a validated self administered questionnaire consisting of 12 items that assess key constructs of sleep. The scale has been found reliable and valid with good overall measurement properties. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9 item overall sleep problems index assessing sleep over the past week. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.|SB Baseline (BL) (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19|The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase. N in the below table refers to number of participants analyzed: 203 in Pregabalin DB CR group and 195 in Placebo DB group, unless otherwise specified.||Units on a scale||Standard Error|Least Squares Mean
835157|NCT01270828|Secondary|Change in the Weekly NRS-Pain (1-Week Recall).|The pain numeric rating scale (NRS Pain) consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain. Participants were asked to rate their pain over the past week.|SB Baseline (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19|The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.||Units on a scale||Standard Error|Least Squares Mean
835158|NCT01270828|Secondary|Change From Baseline to Endpoint in Weekly Mean Pain Score.|The pain numeric rating scale (NRS Pain) consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain|SB Baseline (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19|The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.||Units on a scale||Standard Error|Least Squares Mean
835159|NCT01270828|Secondary|Percentage of Participants With 50% Reduction in the Mean Pain Score.|The 50% pain responders were defined as participants with at least a 50% reduction in the mean pain score from SB baseline to DB endpoint.|13 Weeks|The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.||Percentage of participants|||Number
835160|NCT01270828|Secondary|Percentage of Participants With 30% Reduction in the Mean Pain Score.|The 30% pain responders were defined as participants with at least a 30% reduction in the mean pain score from SB baseline to DB endpoint.|13 Weeks|The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.||Percentage of participants|||Number
835161|NCT01270828|Secondary|Participants With Secondary LTR Based on 5 Day Rolling Average Diary Results|"A secondary LTR endpoint (S-LTR) was defined as the 5 day rolling average pain score during DB, compared to the 5 day randomization baseline pain score. As a secondary endpoint, S-LTR was defined as:
At least a 30% increase in the 5 days rolling average pain score during DB relative to the 5 Day randomization baseline pain score
A 5 days rolling average pain score ≥4. Participants who discontinue due to lack of efficacy or adverse events in the DB phase of the study will also be counted as an LTR."|13 Weeks|The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase||Participants|||Number
835184|NCT01270958|Primary|Urea Nitrogen Value at Baseline and After Treatment Completion|The urea concentration of serum or plasma, conventionally specified in terms of nitrogen content and called blood urea nitrogen (BUN), is an important indicator of renal function. Normal range: 2.5-7.5 mmol/L.|Baseline and treatment completion (up to Week 6)|ITT Population||mmol/L||Standard Deviation|Mean
835162|NCT01270828|Primary|Number of Participants With Loss of Therapeutic Response.|Loss of Therapeutic Response (LTR) is defined as <30% pain response relative to the single blind phase baseline or patient discontinuation due to lack of efficacy or adverse events in the double blind phase of the study. For the calculation of <30% pain response relative to baseline, baseline will be defined as the mean of the last 7 observations prior to the start of SB treatment, which will be compared with the 7 days rolling average of pain response in DB phase. Participants may be discontinued due to lack of efficacy in this study at the discretion of the study physician.|13 Weeks|The full analysis set (FAS) was the primary efficacy analysis set and consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.||Participants|||Number
835163|NCT01270841|Secondary|Reproductive Safety|Change from baseline in sperm concentration|3 months|Subjects with end of study assessments||millions/mL||Standard Deviation|Mean
835164|NCT01270841|Secondary|Change in FSH After 3 Months of Treatment||3 months|ITT population||mIU/mL||Standard Deviation|Mean
835165|NCT01270841|Secondary|Change in Luteinizing Hormone Levels|Changes in values from baseline in LH at month 3|3 months|ITT population||mIU/mL||Standard Deviation|Mean
835166|NCT01270841|Primary|Change in Total Morning Testosterone|Changes in values from baseline in total morning testosterone levels at month 3 comparing Androxal 12.5 and 25 mg to placebo and Testim|3 months|Intent to treat subjects with an assessment after baseline||ng/dL||Standard Deviation|Mean
835167|NCT01270867|Secondary|Secondary Endpoint|Incidence of asymptomatic intracranial hemorrhages (ICH) within 24 (-6/+12) hours post procedure|24 hours|||participants|||Number
835168|NCT01270867|Secondary|Secondary Endpoint|All cause mortality at 90 days|procedure through 90 days|||participants|||Number
835169|NCT01270867|Secondary|Secondary Endpoint|"Good clinical outcomes at 90 days, as assessed by mRS (a good clinical outcome is defined as mRS </= 2)
mRS 0-2 indicates functional independence 0 - No symptoms.
- No significant disability. Able to carry out all usual activities, despite some symptoms.
- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
- Moderate disability. Requires some help, but able to walk unassisted.
- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
- Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
- Dead. https://en.wikipedia.org/wiki/Modified_Rankin_Sca"|90 days|||participants|||Number
835170|NCT01270867|Primary|Primary Safety Endpoint|Incidence of procedure-related serious adverse events (PRSAEs) through 24 hours post procedure (-6/+12 hours).|within 24 hours of procedure|||participants|||Number
835171|NCT01270867|Primary|Primary Efficacy Endpoint|"Revascularization of the occluded territory, defined as at least TICI 2 flow in the treated territory after use of the assigned device.
Thrombolysis in Cerebral Infarction (TICI) grading system for perfusion (ie blood flow through a vessel) Grade 0:No Perfusion. No antegrade flow beyond the point of occlusion. Grade 1:Penetration With Minimal Perfusion. Grade 2:Partial Perfusion. Grade 2a:Only partial filling (<2/3) of the entire vascular territory is visualized.
Grade 2b:Complete filling of all of the expected vascular territory is visualized, but slower ...
Grade 3:Complete Perfusion. For complete info see Higashida RT, Furlan AJ, Roberts H, Tomsick T, Connors B et al. (2003) Trial design and reporting standards for intra-arterial cerebral thrombolysis for acute ischemic stroke. Stroke 34: e109-e137.10.1161/01.STR.0000082721.62796.09 PubMed: 12869717[PubMed]"|acute/procedural|Intent to treat analysis was performed. The non-inferiority hypothesis was tested with Blackwelder's method, assuming a one-sided alpha=0.025 and a clinically relevant non-inferiority margin of 10%.||participants|||Number
835172|NCT01270880|Secondary|Potential Markers for Predicting Drug Response or Efficacy||At baseline, day 1 of course 3, and end of treatment||||||
835173|NCT01270880|Secondary|Association of PFS and PSA Response Rate With Primary and Secondary Target Markers||At 6 months||||||
835174|NCT01270880|Secondary|OS in Metastatic CRPC Who Have Received Prior Docetaxel Therapy||From first dose to death or the date last known alive||||||
835175|NCT01270880|Secondary|Overall Safety and Tolerability of STA-9090||Day 1, 8, and 15 of each course and at end of treatment||||||
835176|NCT01270880|Secondary|Percentage Change in PSA||From baseline to 12 weeks||||||
835177|NCT01270880|Primary|PFS Proportion Achieved With STA-9090 in Men With CRPC Who Have Received Prior Docetaxel Based Therapy|Defined as the time from first dose until the patient demonstrates disease progression based on PSA changes, discontinues STA-9090 therapy (for any reason), or expires (from any cause), whichever occurs first. Estimated with the standard Kaplan-Meier (K-M) method, from which summary statistics of interest (median, 1-year rate, etc.) will be derived.|At 6 months|||months||90% Confidence Interval|Median
835178|NCT01270919|Secondary|To Evaluate the Change in Outcomes From the Preoperative Time Point to Postoperative Time Points in Cases Implanted With the BioDuct® Meniscal Repair Device Using the SF-12, VAS Pain, WOMET and IKDC Subjective Knee Evaluation.||Postoperative compared to preoperative||||||
835179|NCT01270919|Primary|To Demonstrate Repair of the Meniscus 6 Months Post-implantation of the BioDuct® Meniscal Repair Device, Utilizing MRI. To Evaluate Clinical Success Using Postoperative Qualitative Criteria, as Compared to Preoperative Findings.||2 years||||||
835180|NCT01270958|Primary|Percentage of Participants With Appearance of Nasal Polyps and Nasal Ulcers at Baseline and at Treatment Completion|Nasal polyps are non cancerous growths occurring in the nose or sinuses. Nasal ulcers are a break in skin or mucous membrane with loss of surface tissue, disintegration and necrosis of epithelial tissue.|Baseline and treatment completion (up to Week 6)|ITT Population||percentage of participants|||Number
835181|NCT01270958|Primary|Number of Participants With Normal and Abnormal Electrocardiogram (ECG) Results at Baseline and at Treatment Completion|The electrocardiogram is a recording of the electrical activity of the heart as it undergoes excitation (depolarization) and recovery (polarization) to initiate each beat of the heart. Normal ECG readings show a slight flat-dip in between contractions and relaxations. An abnormal ECG is determined by comparing the results of an ECG graph with a standard or normal heart graph. If these flat-dips are not present, it may be an indication of a more serious problem.|Baseline and treatment completion (up to Week 6)|ITT Population||participants|||Number
835182|NCT01270958|Primary|Albumin Value at Baseline and After Treatment Completion|Albumin is a simple water-soluble protein found in many tissues and liquids. Normal range: 35-50 g/L.|Baseline and treatment completion (up to Week 6)|ITT Population||g/L||Standard Deviation|Mean
835187|NCT01270958|Primary|Aspartate Aminotransferase (AST) Value at Baseline and After Treatment Completion|AST is a liver enzyme released into the blood when certain organs or tissues, particularly the liver and heart, are injured. Normal range: <=37 U/L.|Baseline and treatment completion (up to Week 6)|ITT Population||U/L||Standard Deviation|Mean
835188|NCT01270958|Primary|Alkaline Phosphatase Value at Baseline and After Treatment Completion|Alkaline phosphatase is an enzyme produced by the liver or bone. An elevated level of alkaline phosphatase in the blood may indicate a liver or bone problem. Normal range: 30-120 units per liter (U/L).|Baseline and treatment completion (up to Week 6)|ITT Population||U/L||Standard Deviation|Mean
835189|NCT01270958|Primary|Creatinine Value at Baseline and After Treatment Completion|Creatinine is a metabolic waste product in urine that remains relatively constant in an individual and that may be used to establish baseline renal function. Normal range: 53-100 umol/L (female) and 62-120 umol/L (male).|Baseline and treatment completion (up to Week 6)|ITT Population||umol/L||Standard Deviation|Mean
835190|NCT01270958|Primary|Total Bilirubin Value at Baseline and After Treatment Completion|Total bilirubin is formed when hemoglobin breaks down. Bilirubin is excreted in bile and urine, and elevated levels may indicate certain diseases. Normal range: <=17 micromoles per liter (umol/L).|Baseline and treatment completion (up to Week 6)|ITT Population||umol/L||Standard Deviation|Mean
835191|NCT01270958|Primary|Potassium Count at Baseline and After Treatment Completion|Potassium is the major positive ion (cation) found inside of cells. The balance of the electrolytes in our bodies is essential for normal function of our cells and our organs. Normal range: 3.5-5.0 mmol/L.|Baseline and treatment completion (up to Week 6)|ITT Population||mmol/L||Standard Deviation|Mean
835192|NCT01270958|Primary|Sodium Count at Baseline and After Treatment Completion|Sodium is the major positive ion (cation) found outside of cells. The balance of the electrolytes in our bodies is essential for normal function of our cells and our organs. Normal range: 135-145 millimoles per liter (mmol/L).|Baseline and treatment completion (up to Week 6)|ITT Population||mmol/L||Standard Deviation|Mean
835193|NCT01270958|Primary|Platelet Count at Baseline and After Treatment Completion|Platelets are cells found in the blood that play a role in blood clotting. Normal range: 150-400 Giga/L.|Baseline and treatment completion (up to Week 6)|ITT Population||Giga/L||Standard Deviation|Mean
835194|NCT01270958|Primary|White Blood Cell Count at Baseline and After Treatment Completion|White blood cells are cells of the immune system that defend the body against both infectious disease and foreign materials. Normal range: 4-10 10^9 cells per liter (Giga/L).|Baseline and treatment completion (up to Week 6)|ITT Population||Giga/L||Standard Deviation|Mean
835195|NCT01270958|Primary|Red Blood Cell Count at Baseline and After Treatment Completion|Red blood cells are cells in the blood that are used to transport oxygen throughout the body. Normal range: 3.9-5.8 10^12 cells per liter (Tetra/L).|Baseline and treatment completion (up to Week 6)|ITT Population||Tetra/L||Standard Deviation|Mean
835196|NCT01270958|Primary|Hematocrit Values at Baseline and After Treatment Completion|Hematocrit is the proportion of blood volume that is occupied by red blood cells. The hematocrit (Hct) is expressed as liter of red blood cells in liters of blood. Normal range: 0.35-0.50 Liter/Liter.|Baseline and treatment completion (up to Week 6)|ITT Population||Liter/Liter||Standard Deviation|Mean
835197|NCT01270958|Primary|Hemoglobin Values at Baseline and After Treatment Completion|Hemoglobin functions primarily to transport oxygen from the lungs to the body tissues. Normal range: 125-160 grams per liter (g/L).|Baseline and treatment completion (up to Week 6)|ITT Population||g/L||Standard Deviation|Mean
835198|NCT01270958|Primary|Heart Rate at Screening/Visit 1, Visit 2, and Visit 3|Heart rate is measured as the number of heart beats per unit time.|Screening/Visit 1 (3-5 days after Screening Visit), Visit 2 (14 [± 1] days after Visit 1, or Day 15), and Visit 3 (42 [± 1] days after Visit 1, or Day 43)|ITT Population||beats per minute (bpm)||Standard Deviation|Mean
835199|NCT01270958|Primary|Diastolic Blood Pressure at Screening/Visit 1, Visit 2, and Visit 3|Blood pressure (BP) is the pressure exerted by circulating blood upon the walls of blood vessels. During each heartbeat, BP varies between a maximum (systolic) and a minimum (diastolic) pressure.|Screening/Visit 1 (3-5 days after Screening Visit), Visit 2 (14 [± 1] days after Visit 1, or Day 15), and Visit 3 (42 [± 1] days after Visit 1, or Day 43)|ITT Population: Some participants were lost to follow-up and may not have been dosed with study drug.||mmHg||Standard Deviation|Mean
835200|NCT01270958|Primary|Systolic Blood Pressure at Screening/Visit 1, Visit 2, and Visit 3|Blood pressure (BP) is the pressure exerted by circulating blood upon the walls of blood vessels. During each heartbeat, BP varies between a maximum (systolic) and a minimum (diastolic) pressure.|Screening/Visit 1 (3-5 days after Screening Visit), Visit 2 (14 [± 1] days after Visit 1, or Day 15), and Visit 3 (42 [± 1] days after Visit 1, or Day 43)|Intent-to-Treat (ITT) Population: all participants who received at least one dose of study drug. Some participants were lost to follow-up and may not have been dosed with study drug.||millimeters of mercury (mmHg)||Standard Deviation|Mean
835201|NCT01270971|Secondary|Negative Mycology of Target Great Toenail at Week 52|Negative KOH and negative fungal culture.|Week 52|Efficacy analysis was performed using the ITT population. The LOCF was used in order to provide a value for efficacy parameters that were missing.||participants|||Number
835202|NCT01270971|Secondary|Treatment Success (Completely Clear or Almost Clear Nail and Negative Mycology) of Target Great Toenail at Week 52|No clinical evidence of onychomycosis as evidenced by normal toenail plate, no onycholysis, and no subungual hyperkeratosis, or no more than minimal evidence of onychomycosis as evidenced by toenail plate dystrophic or discolored over ≤ 10% of the distal aspect, with minimally evident onycholysis and subungual hyperkeratosis, and negative KOH wet mount and negative fungal culture.|Week 52|Efficacy analysis was performed using the ITT population. The LOCF was used in order to provide a value for efficacy parameters that were missing.||participants|||Number
835203|NCT01270971|Secondary|Completely Clear or Almost Clear Target Great Toenail at Week 52|No clinical evidence of onychomycosis as evidenced by normal toenail plate, no onycholysis, and no subungual hyperkeratosis, or no more than minimal evidence of onychomycosis as evidenced by toenail plate dystrophic or discolored over ≤ 10% of the distal aspect, with minimally evident onycholysis and subungual hyperkeratosis.|Week 52|Efficacy analysis was performed using the ITT population. The LOCF was used in order to provide a value for efficacy parameters that were missing.||participants|||Number
835204|NCT01270971|Primary|Complete Cure (Completely Clear Nail and Negative Mycology) of Target Great Toenail at Week 52|No clinical evidence of onychomycosis as evidenced by normal toenail plate, no onycholysis, and no subungual hyperkeratosis, and negative KOH wet mount and negative fungal culture.|Week 52|Efficacy analysis was performed using the ITT population. The last observation was carried forward (LOCF) in order to provide a value for efficacy parameters that were missing.||participants|||Number
835205|NCT01271036|Secondary|Number of Participants Reporting Subjective Irritation - Neck Application 2|Participants were asked to rate specific sensations they experienced during each application at each site (genital and neck) on a five-point categorical severity scale from mild to excruciating. The sensations included itching, burning, stinging, tingling, warming, and cooling. The number of participants with subjective irritation scores after one week was recorded.|One week|Full Analysis Set||Participants|||Number
835206|NCT01271036|Secondary|Number of Participants Reporting Subjective Irritation - Neck Application 1|Participants were asked to rate specific sensations they experienced during each application at each site (genital and neck) on a five-point categorical severity scale from mild to excruciating. The sensations included itching, burning, stinging, tingling, warming, and cooling. The number of participants with subjective irritation scores after one week was recorded.|One week|Full Analysis Set||Participants|||Number
835207|NCT01271036|Secondary|Number of Participants Reporting Subjective Irritation - Genital Application 2|Participants were asked to rate specific sensations they experienced during each application at each site (genital and neck) on a five-point categorical severity scale from mild to excruciating. The sensations included itching, burning, stinging, tingling, warming, and cooling. The number of participants with subjective irritation scores after one week was recorded.|One week|Full Analysis Set||Participants|||Number
835208|NCT01271036|Secondary|Number of Participants Reporting Subjective Irritation - Genital Application 1|Participants were asked to rate specific sensations they experienced during each application at each site (genital and neck) on a five-point categorical severity scale from mild to excruciating. The sensations included itching, burning, stinging, tingling, warming, and cooling. The number of participants with subjective irritation scores after one week was recorded.|One week|Full Analysis Set||Participants|||Number
835209|NCT01271036|Primary|Number of Participants With Physical Irritation Scores|Severity of physical irritation scored by the Investigator on a scale from 0 (no irritation) to 6 (presence of lesions). Since a score of 0 is required at baseline for inclusion in the study, this any score represents a change from baseline and the trial is considered baseline-controlled. The number of participants with physical irritation scores after one week was recorded (along with categorical severity).|One week|Full Analysis Set||Participants|||Number
835210|NCT01271244|Primary|To Investigate the Effects of Escitalopram on an Absolute or Relative Decrease in Cardiac Sympathetic Function and Serious Cardiac Side Effects as Measured by QT Interval Variability in OEF/OIF Veterans With PTSD.||12 weeks||||||
835211|NCT01271244|Primary|1.To Investigate the Effects of Escitalopram on Cardiac Vagal Function as Measured by R-R Interval Variability, Especially in the HF (0.15-0.5 Hz) Band in OEF/OIF Veterans With PTSD.||12 Weeks|||msec||Standard Deviation|Mean
835212|NCT01271413|Secondary|Digit Symbol Substitution Test||baseline, 7 weeks||||||
835213|NCT01271413|Secondary|Delay Discounting||baseline, 7 weeks||||||
835214|NCT01271413|Secondary|Addiction Severity Index||baseline, 7 weeks||||||
835215|NCT01271413|Secondary|go/No-go||baseline, 7 weeks||||||
835216|NCT01271413|Secondary|Trail-making||baseline, 7 weeks||||||
835217|NCT01271413|Secondary|Episodic Memory||baseline, 7 weeks||||||
835218|NCT01271413|Primary|Working Memory|Change in maximum number of digits correctly recalled in Digit Span Backwards task, from baseline to 7 weeks|baseline, 7 weeks|||digits recalled||Standard Deviation|Mean
835219|NCT01271452|Secondary|Number of Subjects With a Treatment Response at Day 112 Based on the Subject's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the FWS|Number of subjects with a treatment response at Day 112 based on the subject’s assessment of the severity of glabellar lines at maximum contraction using the FWS. The FWS measures wrinkles on a scale from 0=none (best) to 3=severe (worst). Treatment response was defined as a 1 point or greater reduction from Day 0 in the FWS score at maximum contraction.|Day 112|ITT: all randomized subjects.||Number of Subjects|||Number
835220|NCT01271452|Secondary|Number of Subjects With a Treatment Response at Day 98 Based on the Subject's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the FWS|Number of subjects with a treatment response at Day 98 based on the subject’s assessment of the severity of glabellar lines at maximum contraction using the FWS. The FWS measures wrinkles on a scale from 0=none (best) to 3=severe (worst). Treatment response was defined as a 1 point or greater reduction from Day 0 in the FWS score at maximum contraction.|Day 98|ITT: all randomized subjects.||Number of Subjects|||Number
835221|NCT01271452|Secondary|Number of Subjects With a Treatment Response at Day 84 Based on the Subject's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the FWS|Number of subjects with a treatment response at Day 84 based on the subject’s assessment of the severity of glabellar lines at maximum contraction using the FWS. The FWS measures wrinkles on a scale from 0=none (best) to 3=severe (worst). Treatment response was defined as a 1 point or greater reduction from Day 0 in the FWS score at maximum contraction.|Day 84|ITT: all randomized subjects.||Number of Subjects|||Number
835222|NCT01271452|Secondary|Number of Subjects With a Treatment Response at Day 28 Based on the Subject's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the FWS|Number of subjects with a treatment response at Day 28 based on the subject’s assessment of the severity of glabellar lines at maximum contraction using the FWS. The FWS measures wrinkles on a scale from 0=none (best) to 3=severe (worst). Treatment response was defined as a 1 point or greater reduction from Day 0 in the FWS score at maximum contraction.|Day 28|ITT: all randomized subjects.||Number of Subjects|||Number
835223|NCT01271452|Secondary|Number of Subjects With a Treatment Response at Day 112 Based on the Injector's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the FWS|Number of subjects with a treatment response at Day 112 based on the injector’s assessment of the severity of glabellar lines at maximum contraction using the FWS. The FWS measures wrinkles on a scale from 0=none (best) to 3=severe (worst). Treatment response was defined as a 1 point or greater reduction from Day 0 in the FWS score at maximum contraction.|Day 112|ITT: all randomized subjects.||Number of Subjects|||Number
835224|NCT01271452|Secondary|Number of Subjects With a Treatment Response at Day 98 Based on the Injector's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the FWS|Number of subjects with a treatment response at Day 98 based on the injector’s assessment of the severity of glabellar lines at maximum contraction using the FWS. The FWS measures wrinkles on a scale from 0=none (best) to 3=severe (worst). Treatment response was defined as a 1 point or greater reduction from Day 0 in the FWS score at maximum contraction.|Day 98|ITT: all randomized subjects.||Number of Subjects|||Number
835225|NCT01271452|Secondary|Number of Subjects With a Treatment Response at Day 84 Based on the Injector's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the FWS|Number of subjects with a treatment response at Day 84 based on the injector’s assessment of the severity of glabellar lines at maximum contraction using the FWS. The FWS measures wrinkles on a scale from 0=none (best) to 3=severe (worst). Treatment response was defined as a 1 point or greater reduction from Day 0 in the FWS score at maximum contraction.|Day 84|ITT: all randomized subjects.||Number of Subjects|||Number
835226|NCT01271452|Primary|Number of Subjects With a Treatment Response at Day 28 Based on the Injector's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the Facial Wrinkle Scale (FWS)|Number of subjects with a treatment response at Day 28 based on the injector’s assessment of the severity of glabellar lines at maximum contraction using the FWS. The FWS measures wrinkles on a scale from 0=none (best) to 3=severe (worst). Treatment response was defined as a 1 point or greater reduction from Day 0 in the FWS score at maximum contraction.|Day 28|Intent-to-treat (ITT): all randomized subjects.||Number of Subjects|||Number
835227|NCT01271543|Secondary|Time to Complete Laryngoscopy and Successful Intubation||Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation.|||seconds||Standard Deviation|Mean
835228|NCT01271543|Primary|Heart Rate and Blood Pressure Double Product|The double product was measured. The double product is calculated by multiplying the heart rate with the systolic blood pressure. It is also known as the rate pressure product and it is used to measure hemodynamic response.The double product is calculated from the values obtained preinduction, during intubation and after intubation.(5 minutes after intubation)The double products from each time point are averaged to get one mean double product value.|Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation.|double product (DP) of systolic blood pressure multiplied by heart rate||(beats/minute)*mmHg||Standard Deviation|Mean
835229|NCT01271686|Primary|Nocturnal Intraocular Pressure (IOP) Change|Nocturnal IOP means under bimatoprost 0.01% treatment were compared with baseline.|4 weeks|||mmHg||Standard Deviation|Mean
835230|NCT01277042|Secondary|Number of Subjects With Outcome of Pregnancies|The sole pregnancy outcome reported was elective termination with no apparent congenital anomaly.|Throughout the study (from Month 0 up to Month 12)|The analysis was performed on Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented, solely on subjects with outcome of pregnancies.||Subjects|||Number
835231|NCT01277042|Secondary|Number of Subjects Reporting Medically Significant Conditions (MSCs) Including Potential Immune Mediated Diseases (pIMDs)|MSCs were AEs prompting emergency room or physician visits that were not related to common diseases (upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury), or not related to routine visits for physical examination or vaccination. It also included SAEs not related to common diseases. MSCs included pIMDs, a subset of MSCs that included autoimmune diseases and other inflammatory and/or neurological disorders of interest which might or might not have had an autoimmune etiology.|Throughout the study (from Month 0 up to Month 12)|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.||Subjects|||Number
835232|NCT01277042|Primary|Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) and HPV-18|A seroconverted subject was defined as a subject seronegative at baseline whose concentration for anti-HPV-16/18 antibodies, as measured by Enzyme-linked Immunosorbent assay (ELISA) , was higher than or equal to (≥) cut-off value. A seronegative subject was defined as a subject whose antibody concentration was below (<) cut-off value. Cut-off values were 8 ELISA units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.|One month after third vaccination (Month 7)|The analysis was based on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
835233|NCT01277042|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.|Within 30 days (Days 0 – 29) after any vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.||Subjects|||Number
835234|NCT01277042|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination, grade 3 was a SAE that prevented normal activities, and related was defined as a SAE assessed by the investigator to be causally related to the study vaccination. and related was an event assessed by the investigator as causally related to the study vaccination.|Throughout the study (from Month 0 up to Month 12)|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.||Subjects|||Number
835246|NCT01277211|Secondary|Percentage of Participants With Absence of Withdrawal Bleeding, by Cycle|Participants kept diaries to record vaginal bleeding events. They were asked to record, on a daily basis, whether vaginal bleeding was present. Absence of withdrawal bleeding was defined as no bleeding/spotting during the expected bleeding period.|Up to 1 year|ITT Group, which consisted of all randomized participants who used at least one ring/pill.||Percentage of participants|||Number
835235|NCT01277042|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms|Solicited symptoms were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, urticaria and temperature [axillary temperature above (>)37 degrees Celsius(°C)].Grade 3 temperature= temperature >39°C. Grade 3 utricaria= distributed on at least 4 body areas. Grade 3 symptom=prevented normal activity. Gastrointestinal symptoms=nausea, vomiting, diarrhoea and/or abdominal pain. Arthralgia (joint pain): in joints distal from injection site. Any=incidence of a symptom regardless of intensity grade or relationship to vaccination. Related = incidence of a symptom assessed by investigator as related to vaccination.|During the 7 days (Days 0 – 6) after any vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and symptom sheet completed.||Subjects|||Number
835236|NCT01277042|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling. Grade 3 redness and swelling were redness and swelling above 50 millimeters (mm) and grade 3 pain was defined as pain that prevented normal activity. Any was defined as the incidence of a symptom regardless of intensity grade.|During the 7 days (Days 0 – 6) after any vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and symptom sheet completed.||Subjects|||Number
835237|NCT01277042|Secondary|Concentrations for Anti-HPV-16 and Anti-HPV-18 Antibodies|Concentrations are given as geometric mean titers (GMTs), expressed in ELISA units per milliliter (EL.U/mL). Cut-off values were 8 EL.U/mL for anti-HPV-16 antibodies, and 7 EL.U/mL for anti-HPV-18 antibodies.|Before vaccination (Month 0) and one month after third vaccination (Month 7)|The analysis was based on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||EL.U/mL||95% Confidence Interval|Geometric Mean
835238|NCT01277042|Secondary|Number of Subjects Seropositive Against HPV-16 and HPV-18|A seropositive subject was defined as a subject whose anti-HPV-16/18 antibody concentration, as measured by ELISA, was higher than or equal to (≥) cut-off value. Cut-off values were 8 ELISA units per milliliter (EL.U/mL) for anti-HPV-16 antibodies, and 7 EL.U/mL for anti-HPV-18 antibodies.|Before vaccination (Month 0) and one month after third vaccination (Month 7)|The analysis was based on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
835239|NCT01277081|Secondary|Overall Cold Symptoms Score|Overall cold symptom score was assessed by asking the question “my cold symptoms are improved” only post consuming the drink at baseline, 15 and 60 minutes . The response to the question was rated by participants on a 5 point (0-4) rating scale with ‘0’ being labeled as ‘strongly disagree’ and ‘4’ being labeled as ‘strongly agree’.|Baseline to 15 and 60 minutes|ITT population: all randomized participants who had at least one post-baseline efficacy evaluation.||Score on a scale||Standard Error|Mean
835240|NCT01277081|Secondary|Soothing Attribute Scores|Soothing attribute of test treatment was assessed by asking the question “if the hot drink is soothing” at baseline, 15 and 60 minutes. The response to the question was rated by participants on a 5 point (0-4) rating scale with ‘0’ being labeled as ‘strongly disagree’ and ‘4’ being labeled as ‘strongly agree’.|Baseline to 15 and 60 minutes|ITT population: all randomized participants who had at least one post-baseline efficacy evaluation.||Score on a scale||Standard Deviation|Mean
835241|NCT01277081|Secondary|Cold Symptoms Score Post 60 Minutes|A mean Cold symptom score was calculated at baseline, 30 seconds, 2, 5, 15 and 60 minutes from participant responses to questions relating to cold symptoms i.e. “My head feels clear”, “I feel soothing in my throat” and “I feel my cough is being soothed”. The cold symptom scores were rated by the participants on a 5 point (0-4) rating scale with ‘0’ being labeled as ‘strongly disagree’ and ‘4’ being labeled as ‘strongly agree’. For each participant, a mean score was derived by summing the responses and dividing by the number of questions answered.|Baseline to 60 minutes|ITT population: all randomized participants who had at least one post-baseline efficacy evaluation.||Score on a scale||95% Confidence Interval|Mean
835242|NCT01277081|Secondary|Cold Symptoms Score Post 15 Minutes|A mean Cold symptom score was calculated at baseline, 30 seconds, 2, 5 and 15 minutes from participant responses to questions relating to cold symptoms i.e. “My head feels clear”, “I feel soothing in my throat” and “I feel my cough is being soothed”. The cold symptom scores were rated by the participants on a 5 point (0-4) rating scale with ‘0’ being labeled as ‘strongly disagree’ and ‘4’ being labeled as ‘strongly agree’. For each participant, a mean score was derived by summing the responses and dividing by the number of questions answered.|Baseline to 15 minutes|ITT Population: all randomized participants who had at least one post-baseline efficacy evaluation.||Score on a scale||95% Confidence Interval|Mean
835243|NCT01277081|Secondary|Breathing Score Post 60 Minutes|A mean breathing score was calculated at baseline, 30 seconds, 2, 5, 15 and 60 minutes, derived from participant responses to questions relating to breathing i.e. “my breathing feels easy”, “I feel airways are open”, “I feel a cooling sensation in my throat”, “I can feel the air flowing to my lungs easily”, “My nose feels less blocked” and “I feel my breathing is comfortable”. The breathing scores were rated by the participants on a 5 point (0-4) rating scale with ‘0’ being labeled as ‘strongly disagree’ and ‘4’ being labeled as ‘strongly agree’. For each participant, a mean score was derived by summing the responses and dividing by the number of questions answered.|Baseline to 60 minutes|ITT population: All randomized participants who had at least one post-baseline efficacy evaluation.||Score on a scale||95% Confidence Interval|Mean
835244|NCT01277081|Primary|Breathing Scores Post 15 Minutes|A mean breathing score was calculated at baseline, 30 seconds, 2, 5 and 15 minutes, derived from participant responses to questions relating to breathing i.e. “my breathing feels easy”, “I feel airways are open”, “I feel a cooling sensation in my throat”, “I can feel the air flowing to my lungs easily”, “My nose feels less blocked” and “I feel my breathing is comfortable”. The breathing scores were rated by the participants on a 5 point (0-4) rating scale with ‘0’ being labeled as ‘strongly disagree’ and ‘4’ being labeled as ‘strongly agree’. For each participant, a mean score was derived by summing the responses and dividing by the number of questions answered.|Baseline to 15 minutes|Intent to Treat (ITT) Population: All randomized participants who had at least one post-baseline efficacy evaluation.||Score on a Scale||95% Confidence Interval|Mean
835247|NCT01277211|Secondary|Percentage of Participants With Intermenstrual (Breakthrough) Bleeding/Spotting, by Cycle|"Participants kept diaries to record vaginal bleeding events. They were asked to record, on a daily basis, whether they experienced vaginal bleeding, which included BLEEDING or SPOTTING, at any time during a cycle other than normal menstruation while in the study. (This is also known as breakthough bleeding.) Vaginal bleeding that required >=2 pads/tampons per day was classified as BLEEDING. Vaginal bleeding that required <=1 pad/tampon per day was classified as SPOTTING."|Up to 1 year|ITT Group, which consisted of all randomized participants who used at least one ring/pill.||Percentage of participants|||Number
835248|NCT01277211|Primary|Pearl Index, by Treatment Group|Primary Efficacy Outcome measure for this study was contraceptive efficacy, or the prevention of in-treatment pregnancy. The total incidence of in-treatment pregnancies was expressed as the Pearl Index, which is defined as the number of in-treatment pregnancies per 100 woman-years of exposure (one woman-year defined as a period of 365.25 days).|Up to 1 year|Restricted Intent-to-Treat (R-ITT) Group, which consisted of all participants from the Intent-to-Treat (ITT) Group who had at least one cycle at risk (no condom use and confirmed intercourse).||Pregnancies per 100 woman-years||95% Confidence Interval|Mean
835249|NCT01277302|Secondary|Percentage of Participants With Intraretinal Edema|The presence of intraretinal edema was defined as the presence of subretinal fluid, cystoid spaces, or central retinal thickness ≥ 300 µm as evaluated in spectral-domain optical coherence tomography images by the Digital Angiography Reading Center, the central reading center. At baseline, all participants in the Monthly and PRN groups had presence of edema.|Month 7 to Month 15|Intent-to-treat population: All enrolled participants who received at least 1 ranibizumab injection in the study. The analysis was based on observed data without imputation for missing values.||Percentage of participants||95% Confidence Interval|Number
835250|NCT01277302|Secondary|Mean Change From Baseline in Central Foveal Thickness|Central foveal thickness was assessed monthly in the study eye using spectral-domain optical coherence tomography. Central foveal thickness was computed using the automated Cirrus Review software (DOCTR CZM Cirrus OCT Grader Reading Manual, Version 1.02). All participants in the Monthly and PRN groups had a baseline central foveal thickness > 300 µm at baseline. A decrease in foveal thickness suggests a reduction in macular edema. A negative change score indicates improvement.|Month 1 to Month 15|Intent-to-treat population: All enrolled participants who received at least 1 ranibizumab injection in the study. The analysis was based on observed data without imputation for missing values.||µm||Standard Deviation|Mean
835251|NCT01277302|Secondary|Percentage of Participants With a Central Foveal Thickness of ≤ 300 µm|Central foveal thickness was assessed monthly in the study eye using spectral-domain optical coherence tomography. Central foveal thickness was computed using the automated Cirrus Review software (DOCTR CZM Cirrus OCT Grader Reading Manual, Version 1.02). All participants in the Monthly and PRN groups had a baseline central foveal thickness > 300 µm at baseline.|Month 7 to Month 15|Intent-to-treat population: All enrolled participants who received at least 1 ranibizumab injection in the study. The analysis was based on observed data without imputation for missing values.||Percentage of participants||95% Confidence Interval|Number
835252|NCT01277302|Secondary|Percentage of Participants Who Lost < 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline|BCVA was measured in the study eye using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision.|Month 7 to Month 15|Intent-to-treat population: All enrolled participants who received at least 1 ranibizumab injection in the study. The analysis was based on observed data without imputation for missing values.||Percentage of participants||95% Confidence Interval|Number
835253|NCT01277302|Secondary|Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score|BCVA was measured in the study eye using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision. A positive change score indicates improvement.|Month 1 to Month 15|Intent-to-treat population: All enrolled participants who received at least 1 ranibizumab injection in the study. The analysis was based on observed data without imputation for missing values.||Letters||Standard Deviation|Mean
835254|NCT01277302|Secondary|Percentage of Participants With a Visual Acuity (VA) Snellen Equivalent of 20/40 or Better|VA was measured in the study eye using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart starting at a test distance of 4 meters. An increase in the number of lines read correctly by the patient in the ETDRS chart indicates an improvement of vision. The Snellen equivalent of 20/40 or better is 69 or more letters correctly read in the EDTRS chart.|Month 7 to Month 15|Intent-to-treat population: All enrolled participants who received at least 1 ranibizumab injection in the study. The analysis was based on observed data without imputation for missing values.||Percentage of participants||95% Confidence Interval|Number
835255|NCT01277302|Secondary|Percentage of Participants Who Gained ≥ 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline|BCVA was measured in the study eye using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision.|Month 7 to Month 15|Intent-to-treat population: All enrolled participants who received at least 1 ranibizumab injection in the study. The analysis was based on observed data without imputation for missing values.||Percentage of participants||95% Confidence Interval|Number
835256|NCT01277302|Secondary|Visual Acuity Change From Previous Month During the Alternate Dose Regimen Period in Subjects Who Met the VA-OCT Stability Criteria at the Previous Month|BCVA was measured in the study eye using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision. A positive change score indicates improvement. This outcome measure is not relevant for subjects in the non-randomized group because they never met the VA-OCT stability criteria.|Month 7 through Month 15|Intent-to-treat population, randomized: All enrolled participants who received at least 1 ranibizumab injection in the study and were randomized into the monthly or PRN treatment groups. The analysis was based on observed data without imputation for missing values.||Letters||Standard Deviation|Mean
835257|NCT01277302|Primary|Trend of Change From Baseline in the Best Corrected Visual Acuity (BCVA) Scores From Month 7 to Month 15|BCVA was measured in the study eye using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision. A positive change score indicates improvement. The reported data are the observed changes from Baseline in BCVA at Months 7 and 15. For the statistical analysis, the interaction term of treatment by time in a longitudinal model was used to assess whether there was a difference in the trend of change from Baseline in the visual acuity scores from Month 7 to Month 15 between the 2 randomized treatment groups, Monthly and PRN.|Baseline to Month 15|Intent-to-treat population, randomized: All enrolled participants who received at least 1 ranibizumab injection in the study and were randomized into the Monthly or PRN treatment groups. The analysis was based on observed data without imputation for missing values.||Letters||Standard Deviation|Mean
835258|NCT01277354|Primary|CPT Effectiveness as Determined by the Number of Participants With CAPS Score Decrease of 50% From Baseline to Week 6|The CAPS will be used in the diagnosis of PTSD, assessment of the impact of symptoms on function, assessment of the severity of symptoms at baseline, and weekly throughout the study. The CAPS in this particular study must decrease by 50% for CPT to be deemed effective.|6 weeks|Please note that there were only a total of 2 participants involved in this study. Funding was lost to continue and the study was terminated.||Participants|||Count of Participants
835259|NCT01277510|Secondary|Percent Change From Baseline in Mean Ionized Calcium During the Efficacy Assessment Phase|The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase. When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available postbaseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used.|From Baseline to the Efficacy Assessment Phase, Weeks 25-30.|Full analysis set; only participants with available data were included in the analysis.||percent change||95% Confidence Interval|Least Squares Mean
835260|NCT01277510|Secondary|Growth Velocity From End of Double-blind Phase to End of Open-label Phase|Linear growth velocity (cm/year) = 52 x change in height (cm) / number of weeks between the two assessments. End of open-label phase visit was at Week 60 by design but the last assessment in the open-label phase was used due to the early termination of the study.|End of double-blind phase (Week 30) until end of the open-label phase (Week 60)|Full analysis set. Only participants with available data were included in the anaysis.||cm/year||Standard Deviation|Mean
835261|NCT01277510|Secondary|Growth Velocity From Baseline to End of Double-blind Phase|Linear growth velocity (cm/year) = 52 x change in height (cm) / number of weeks between the two assessments. End of double-blind phase visit was at Week 30 by design but the last assessment in the double-blind phase was used due to the early termination of the study.|From Baseline to end of Efficacy Assessment at Week 30|Full analysis set; the last assessment in the double-blind phase was used due to the early termination of the study. Only participants with available data are included in the analysis.||cm/year||95% Confidence Interval|Least Squares Mean
835262|NCT01277510|Secondary|Percent Change From Baseline in Mean Phosphorous Product (Ca x P) During the Efficacy Assessment Phase|The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase. When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available postbaseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used.|From Baseline to end of Efficacy Assessment Period, assessed up to 30 weeks|Full analysis set||percent change||95% Confidence Interval|Least Squares Mean
835263|NCT01277510|Secondary|Percent Change From Baseline in Mean Serum Phosphorus During the Efficacy Assessment Phase|The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase. When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available postbaseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used.|From Baseline to the Efficacy Assessment Phase, Weeks 25-30.|Full analysis set; data for one participant in the Placebo group were not available.||percent change||95% Confidence Interval|Least Squares Mean
835264|NCT01277510|Secondary|Percent Change From Baseline in Mean Corrected Total Serum Calcium During the Efficacy Assessment Period|"Serum calcium was reported as a corrected value by the central laboratory based on calcium and albumin concentrations: Corrected total calcium (mg/dL) = measured total serum calcium (mg/dL) + 0.8 (4.0 – Serum albumin (g/dL)). The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase. When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available postbaseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used."|From Baseline to the Efficacy Assessment Phase, Weeks 25-30.|Full analysis set||percent change||95% Confidence Interval|Least Squares Mean
835265|NCT01277510|Secondary|Percentage of Participants Achieving Mean iPTH ≤ 300 pg/mL (31.8 Pmol/L) During the Efficacy Assessment Phase|The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase. When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available postbaseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used.|From Baseline to the Efficacy Assessment Phase (EAP), Weeks 25-30|Full analysis set||pecentage of participants|||Number
835266|NCT01277510|Primary|Percentage of Participants Achieving ≥ 30% Reduction in Mean iPTH From Baseline to the Efficacy Assessment Phase|The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase (EAP; Weeks 25 - 30). When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available post-baseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used.|From Baseline to the Efficacy Assessment Phase, Weeks 25-30|Full analysis set, which includes all randomized participants with at least 1 post-baseline assessment.||percentage of participants|||Number
835267|NCT01277523|Secondary|Clinically Relevant Abnormalities for Physical Examination, ECG, Vital Signs and Laboratory Tests|Clinically relevant abnormalities for physical examination, ECG, vital signs and laboratory tests. New abnormal findings or worsening of baseline conditions were reported as adverse events.|From first drug administration until 30 days after last drug intake, up to 142 days|Treated set which included all randomised patients who were dispensed and received, at least one documented dose of trial medication.||percentage of participants|||Number
835268|NCT01277523|Secondary|Analysis of Time to First Asthma Exacerbation During the 12 Week Treatment Period.|Time in days to first asthma exacerbation during the 12 week treatment period. The median time to first asthma exacerbation was not calculable, so the number of patients who experienced an asthma exacerbation are presented for the measured values.|12 weeks|Full Analysis Set (FAS) was the same as the treated set which included all randomised patients who were dispensed and received at least one documented dose of trial medication.||participants|||Number
835269|NCT01277523|Secondary|Time to First Severe Asthma Exacerbation During the 12-week Treatment Period.|"Time in days to first severe asthma exacerbation during the 12 week treatment period. The median time to first severe asthma exacerbation was not calculable, so the number of patients who experienced a severe asthma exacerbation are presented for the measured values.
A severe asthma exacerbation was defined as a subgroup of all asthma exacerbations that required an initiation of treatment with systemic corticosteroids for at least 3 days or, in case of ongoing and pre-existing systemic corticosteroid therapy, requiring at least doubling of previous daily doses of systemic corticosteroids for at least 3 days."|12 weeks|Full Analysis Set (FAS) was the same as the treated set which included all randomised patients who were dispensed and received at least one documented dose of trial medication.||participants|||Number
835270|NCT01277523|Secondary|Use of PRN Rescue Medication During the Night-time|"Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used during the night-time based on the weekly mean at week 12.
Measured values presented are actually adjusted means"|Baseline and 12 weeks|Full Analysis Set (FAS) was the same as the treated set which included all randomised patients who were dispensed and received at least one documented dose of trial medication. Missing data was imputed by the available data from the patient. Completely missing data were handled by the statistical model.||Number of puffs of rescue medication||Standard Error|Mean
835271|NCT01277523|Secondary|Use of PRN Rescue Medication During the Daytime|"Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used during the daytime based on the weekly mean at week 12.
Measured values presented are actually adjusted means."|Baseline and 12 weeks|Full Analysis Set (FAS) was the same as the treated set which included all randomised patients who were dispensed and received at least one documented dose of trial medication. Missing data was imputed by the available data from the patient. Completely missing data were handled by the statistical model.||Number of puffs of rescue medication||Standard Error|Mean
835272|NCT01277523|Secondary|Use of PRN Rescue Medication During the Day|"Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used during the day (24 hour period) based on the weekly mean at week 12.
The measured values presented are actually adjusted means."|Baseline and 12 weeks|Full Analysis Set (FAS) was the same as the treated set which included all randomised patients who were dispensed and received at least one documented dose of trial medication. Missing data was imputed by the available data from the patient. Completely missing data were handled by the statistical model.||Number of puffs of rescue medication||Standard Error|Mean
835273|NCT01277523|Secondary|ACQ Total Score Responders|"Responder rates based on the ACQ total score after 12 weeks of treatment. Analysis was performed using the following categories and definitions: responder (change from trial baseline ≤-0.5), no change (-0.5 <change from trial baseline <0.5) and worsening (change from trial baseline ≥0.5) No statistical testing was performed for ACQ total score responders.
The ACQ is a scale containing 7 questions, each question has a 7-point scale which ranges from 0 to 6; a score of 0 corresponds to no impairment and a score of 6 corresponds to maximum impairment."|12 weeks|Full Analysis Set which included all randomised patients who were dispensed and received at least one documented dose of trial medication. Missing data for patients not withdrawn from the study were either categorised as no change or based on available data. Withdrawn patients were imputed based upon discontinuation reason.||percentage of participants|||Number
835274|NCT01277523|Secondary|Control of Asthma as Assessed by ACQ Total Score|"Change from baseline in Asthma Control Questionnaire (ACQ) total score measured at week 12.
The ACQ is a scale containing 7 questions. Each question has a 7 point scale which ranges from 0 to 6. A score of 0 corresponds to no impairment and a score of 6 corresponds to maximum impairment. ACQ total score is calculated as the mean of the responses to all 7 questions.
The measured values presented are actually adjusted means."|Baseline and 12 weeks|Full Analysis Set (FAS) was the same as the treated set which included all randomised patients who were dispensed and received at least one documented dose of trial medication. Missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||units on a scale||Standard Error|Mean
835275|NCT01277523|Secondary|ACQ6 Score Responders|"Responder rates based on the ACQ6 score after 12 weeks of treatment. Analysis was performed using the following categories and definitions: responder (change from trial baseline <= -0.5), no change (-0.5 < change from trial baseline <0.5) and worsening (change from trial baseline >= 0.5).
The ACQ is a scale containing 7 questions, each question has a 7- point scale which ranges from 0 to 6; a score of 0 corresponds to no impairment and a score of 6 corresponds to maximum impairment. ACQ6 is calculated as the mean of the responses to the first 6 questions of the ACQ6.
No statistical testing was performed on ACQ6 responders."|12 weeks|"Full Analysis Set which included all randomised patients who were dispensed and received at least one documented dose of trial medication.
Missing data for patients not withdrawn from the study were either categorised as no change or based on available data, withdrawn patients were imputed based upon discontinuation reason."||percentage of participants|||Number
835298|NCT01277601|Secondary|Percentage of Participants With HBsAg Seroconversion at Weeks 72, 96, and 120|"HBsAg seroconversion was defined as change of detectable antibody to HBsAg from negative to positive. Proportions are based on a Kaplan-Meier estimate.
The analysis visit window for Week 72 comprised Week 70 through Week 78, so results up to Week 78 are included in this analysis. The analysis visit window for Week 96 comprised Week 90 through Week 102, so results up to Week 102 are included in this analysis. The analysis visit window for Week 120 comprised Week 114 through Week 120."|Baseline; Weeks 72, 96, and 120|Full Analysis Set||percentage of participants|||Number
835276|NCT01277523|Secondary|Control of Asthma as Assessed by ACQ6 Score.|"Change from baseline in Asthma Control Questionnaire (ACQ) 6 score measured at week 12
The ACQ is a scale containing 7 questions, each question has a 7 point scale which ranges from 0 to 6. A score of 0 corresponds to no impairment and a score of 6 corresponds to maximum impairment. ACQ6 score is calculated as the mean of the responses to the first 6 questions of the ACQ6.
The measured values presented are actually adjusted means."|Baseline and 12 weeks|Full Analysis Set (FAS) was the same as the treated set which included all randomised patients who were dispensed and received at least one documented dose of trial medication. Missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||units on a scale||Standard Error|Mean
835277|NCT01277523|Secondary|FVC AUC (0-3h) Change From Baseline|"Change from baseline of area under the curve (AUC) from 0 to 3 hours for FVC (Forced vital capacity) (FVC AUC0–3h) after 12 weeks of treatment. The AUC was calculated by using the trapezoidal rule divided by the observation time (3h).
Measured values presented are actually adjusted means."|Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 12 weeks|Full Analysis Set (FAS) was the same as the treated set which included all randomised patients who were dispensed and received at least one documented dose of trial medication. Missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||litres||Standard Error|Mean
835278|NCT01277523|Secondary|FEV1 AUC (0-3h) Change From Baseline|"Change from baseline of area under the curve (AUC) from 0 to 3 hours for FEV1 (FEV1 AUC 0–3h) after 12 weeks of treatment. The AUC was calculated by using the trapezoidal rule divided by the observation time (3h).
Measured values presented are actually adjusted means."|Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 12 weeks|Full Analysis Set (FAS) was the same as the treated set which included all randomised patients who were dispensed and received at least one documented dose of trial medication. Missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Litres||Standard Error|Mean
835279|NCT01277523|Secondary|FVC peak0-3 Change From Baseline|"Change from baseline in Maximum forced vital capacity (FVC) measured within the first 3 hours after administration of trial medication (FVC peak0–3h) after 12 weeks of treatment.
The measured values presented are actually adjusted means."|Baseline and 12 weeks|Full Analysis Set (FAS) was the same as the treated set which included all randomised patients who were dispensed and received at least one documented dose of trial medication. Missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Litres||Standard Error|Mean
835280|NCT01277523|Secondary|Trough FEV1 Change From Baseline|"Change from baseline in Trough (pre-dose) Forced expiratory volume in 1 second (FEV1) measured at week 12.
Measured values presented are actually adjusted means."|Baseline and 12 weeks|Full Analysis Set (FAS) was the same as the treated set which included all randomised patients who were dispensed and received at least one documented dose of trial medication. Missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||litres||Standard Error|Mean
835281|NCT01277523|Primary|FEV1 peak0-3 Change From Baseline|"Change from baseline in peak forced expiratory volume in 1 second within the first 3 hours post dosing (FEV1 peak0-3) measured at week 12.
Measured values presented are actually adjusted means."|Baseline and 12 weeks|Full Analysis Set (FAS) was the same as the treated set which included all randomised patients who were dispensed and received at least one documented dose of trial medication. Missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||litres||Standard Error|Mean
835282|NCT01277549|Primary|CD34+ Cell Collection Efficiency|The collection efficiency for CD34+ cells is defined as the percent of processed CD34+ cells that were in fact collected.|one day|Results are given for all per protocol subjects.||% of processed CD34+ cells collected||Full Range|Median
835283|NCT01277549|Secondary|Viability of the Collected MNC Product|The viability of the collected white blood cells was assessed using the 7-AAD (7-amino actinomycin D) viability dye in a flow cytometric assay. Viability assessment is incorporated into the CD34 assay. This assay was only performed on G-CSF mobilized donors as nonmobilized donor have too few CD34+ cells to detect. Thus viability of the collected WBCs is reported only for the G-CSF mobilized arm.|One day|Per Protocol||percentage of total WBCs collected||Full Range|Median
835284|NCT01277549|Secondary|Granulocyte % of MNC Product|Granulocyte contamination of the MNC product was quantitated as the percent of total product WBC (white blood cell) that were segmented granulocytes or bands.|One day|Results given for all per protocol subjects.||percentage of WBCs collected||Full Range|Median
835285|NCT01277549|Secondary|Hematocrit of MNC Product|The hematocrit of the collected product was used to quantitate RBC (red blood cell) contamination.|One Day|Per protocol||RBC % of product volume||Full Range|Median
835286|NCT01277549|Secondary|Platelet Collection Efficiency|Platelet contamination of the cell product was measured as the platelet collection efficiency, that is, as the percent of platelets processed that were collected.|One Day|Per protocol||% of processed platelets collected||Full Range|Median
835287|NCT01277549|Primary|Mononuclear Cell Collection Efficiency|The collection efficiency for a given cell type is defined as the percent of processed cells of that cell type that are in fact collected.|One day|Results are given for all per protocol subjects.||% of processed MNCs that were collected||Full Range|Median
835288|NCT01277601|Secondary|Percentage of Participants Who Required Retreatment|Participants in the TDF 120 week group were not eligible to enter the retreatment phase and are not presented.|Up to 120 weeks|Safety Analysis Set. Participants in the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups were analyzed.||percentage of participants|||Number
835299|NCT01277601|Secondary|Percentage of Participants With HBsAg Loss at Weeks 96 and 120|"Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. Proportions are based on a Kaplan-Meier estimate.
The analysis visit window for Week 96 comprised study Week 90 through Week 102, so results up to Week 102 are included in this analysis. The analysis visit window for Week 120 comprised study Week 114 through Week 126, so results up to Week 126 are included in this analysis."|Baseline; Weeks 96 and 120|Full Analysis Set||percentage of participants|||Number
835289|NCT01277601|Secondary|Percentage of Participants With Normal ALT at Week 120|"Normal ALT was ≤ 30 U/L for males and ≤ 19 U/L for females (based on the American Association for the Study of Liver Diseases (AASLD) 2008 guidelines), and ≤ 41 U/L for males and ≤ 31 U/L for females (based on central laboratory upper limit of the normal range (ULN) for ALT).
For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the Not Retreated column for participants who had not entered the retreatment phase by Week 120, and in the Retreated column for participants who did enter the retreatment phase by Week 120."|Week 120|Full Analysis Set. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the endpoint.||percentage of participants|||Number
835290|NCT01277601|Secondary|Percentage of Participants With Normal ALT at Week 96|"Normal ALT was ≤ 30 U/L for males and ≤ 19 U/L for females (based on the American Association for the Study of Liver Diseases (AASLD) 2008 guidelines), and ≤ 41 U/L for males and ≤ 31 U/L for females (based on central laboratory upper limit of the normal range (ULN) for ALT).
For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the Not Retreated column for participants who had not entered the retreatment phase by Week 96, and in the Retreated column for participants who did enter the retreatment phase by Week 96."|Week 96|Full Analysis Set. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the endpoint.||percentage of participants|||Number
835291|NCT01277601|Secondary|Percentage of Participants With Normal ALT at Week 72|"Normal ALT was ≤ 30 U/L for males and ≤ 19 U/L for females (based on the American Association for the Study of Liver Diseases (AASLD) 2008 guidelines), and ≤ 41 U/L for males and ≤ 31 U/L for females (based on central laboratory upper limit of the normal range (ULN) for ALT).
For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the Not Retreated column for participants who had not entered the retreatment phase by Week 72, and in the Retreated column for participants who did enter the retreatment phase by Week 72."|Week 72|Full Analysis Set. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the endpoint.||percentage of participants|||Number
835292|NCT01277601|Secondary|Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at Week 120|"For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the Not Retreated column for participants who had not entered the retreatment phase by Week 120, and in the Retreated column for participants who did enter the retreatment phase by Week 120."|Week 120|Full Analysis Set. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the endpoint.||percentage of participants|||Number
835293|NCT01277601|Secondary|Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at Week 96|"For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the Not Retreated column for participants who had not entered the retreatment phase by Week 96, and in the Retreated column for participants who did enter the retreatment phase by Week 96."|Week 96|Full Analysis Set. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the endpoint.||percentage of participants|||Number
835294|NCT01277601|Secondary|Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at Week 72|"For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the Not Retreated column for participants who had not entered the retreatment phase by Week 72, and in the Retreated column for participants who did enter the retreatment phase by Week 72."|Week 72|Full Analysis Set. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the endpoint.||percentage of participants|||Number
835295|NCT01277601|Secondary|Percentage of Participants With HBeAg Loss and Seroconversion at Week 120|"Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive. Percentages were based on the number of subjects with non-missing HBeAg results or missing HBeAg results imputed as failures at each visit.
For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the Not Retreated column for participants who had not entered the retreatment phase by Week 120, and in the Retreated column for participants who did enter the retreatment phase by Week 120."|Baseline; Week 120|Participants in the Full Analysis Set who were HBeAg reactive or indeterminate at baseline were analyzed. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the outcome.||percentage of participants|||Number
835296|NCT01277601|Secondary|Percentage of Participants With HBeAg Loss and Seroconversion at Week 96|"Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive. Percentages were based on the number of subjects with non-missing HBeAg results or missing HBeAg results imputed as failures at each visit.
For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the Not Retreated column for participants who had not entered the retreatment phase by Week 96, and in the Retreated column for participants who did enter the retreatment phase by Week 96."|Baseline; Week 96|Participants in the Full Analysis Set who were HBeAg reactive or indeterminate at baseline were analyzed. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the outcome.||percentage of participants|||Number
835297|NCT01277601|Secondary|Percentage of Participants With HBeAg Loss and Seroconversion at Week 72|"Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive. Percentages were based on the number of subjects with non-missing HBeAg results or missing HBeAg results imputed as failures at each visit.
For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the Not Retreated column for participants who had not entered the retreatment phase by Week 72, and in the Retreated column for participants who did enter the retreatment phase by Week 72."|Baseline; Week 72|Participants in the Full Analysis Set who were HBeAg reactive or indeterminate at baseline were analyzed. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the outcome.||percentage of participants|||Number
835300|NCT01277601|Secondary|Percentage of Participants With HBsAg Loss at Week 72 Following Treatment With TDF (48 Weeks) Plus Peg-IFN (16 Weeks) Combination Versus Peg-IFN Alone for 48 Weeks or TDF Alone|"Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. Proportions are based on a Kaplan-Meier estimate.
The analysis visit window for Week 72 comprised Week 70 through Week 78, so results up to Week 78 are included in this analysis."|Baseline; Week 72|Full Analysis Set. Participants in the TDF 48 week + Peg-IFN 16 Weeks, TDF 120 Weeks, and Peg-IFN 48 Weeks groups were analyzed.||percentage of participants|||Number
835301|NCT01277601|Primary|Percentage of Participants With HBsAg Loss at Week 72 Following Treatment With 48 Weeks of TDF Plus Peg-IFN Combination Versus Peg-IFN Alone for 48 Weeks or TDF Alone|"Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. Proportions are based on a Kaplan-Meier estimate.
The analysis visit window for Week 72 comprised Week 70 through Week 78, so results up to Week 78 are included in this analysis."|Baseline; Week 72|Full Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants in the TDF+Peg-IFN 48 Weeks, TDF 120 Weeks, and Peg-IFN 48 Weeks groups were analyzed by randomized treatment.||percentage of participants|||Number
835302|NCT01277666|Secondary|Incidence of Adverse Events (AE) and Serious Adverse Events (SAE)|Data for number of participants who presented one or more adverse events (serious or non serious) was reported. An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.|Up to Week 12|The Safety population comprised of all participants in the intent to treat population except those who did not take at least one dose of investigational product.||Participants|||Number
835303|NCT01277666|Secondary|Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Both Weeks 8 and 12|The IBDQ is a 32-item IBD-specific health related quality of life instrument evaluating general activities of daily living, intestinal function, social performance, personal interactions, and emotional status. Each item response was graded from 1 to 7 for each area evaluated. A higher score indicated better function in that area. Total IBDQ score was obtained by summing up scores for all 32 questions. Total IBDQ score ranged from 32 to 224. A higher score indicated better quality of life and lower score indicated worse quality of life. Day 1 assessment was considered as Baseline. Change from Baseline was calculated by subtracting value at Baseline from value at Weeks 8 and 12.|Baseline (Week 0), Week 8 and Week 12|Intent to treat population. Only those participants available at specified time points were analyzed.||Score on scale||Standard Error|Least Squares Mean
835304|NCT01277666|Secondary|Percentage of Participant Achieving Clinical Remission (CDAI <150 Points) at Week 8|Clinical remission is defined as a CDAI score < 150 points if baseline CDAI is >= 150. If baseline CDAI is <150, the participant was not considered in remission. participants with missing CDAI scores were considered not in remission according to the missing=no effect imputation. Percentage of participants achieving clinical remission with CDAI <150 points at Week 8 was presented.|Week 8|Intent to treat population.||Percentage of participants||95% Confidence Interval|Number
835305|NCT01277666|Secondary|Percentage of Participants With a Clinical Response (CDAI Decrease From Baseline of >=100 Points) at Week 8|CDAI is a recognized scoring system to categorize disease severity with scores of >= 220 to <= 450 describing the moderately-to-severely active population. The score was algorithmically derived from the sum of participant reported Crohn’s disease symptoms recorded over 7 days and investigator recorded assessments of the participant’s condition, laboratory parameters and use of anti-diarrhoeal medication. Both participants and investigators made their entries via IVRS each evening before going to bed. Percentage of Participants with a clinical response CDAI decrease from baseline of >=100 points at Week 8 was presented.|Week 8|Intent to treat population.||Percentage of Participants||95% Confidence Interval|Number
835306|NCT01277666|Secondary|Percentage of Participants Achieving Clinical Remission (CDAI <150 Points) at Both Week 8 and Week 12|Clinical remission is defined as a CDAI score < 150 points if baseline CDAI is >= 150. If baseline CDAI is <150, the participant was not considered in remission. participants with missing CDAI scores were considered not in remission according to the missing=no effect imputation. Percentage of participants in clinical remission defined as a CDAI score of less than 150 points at other time points was presented.|Week 8 and 12|Intent to treat population.||Percentage of participants||95% Confidence Interval|Number
835307|NCT01277666|Secondary|Percentage of Participants With a Clinical Response (CDAI Decrease From Baseline of >= 100 Points) at Both Week 8 and Week 12|Responders were defined as participants with CDAI decrease from baseline of >= 100 points. CDAI is a recognized scoring system to categorize disease severity with scores of >= 220 to <= 450 describing the moderately-to-severely active population. The score was algorithmically derived from the sum of participant reported Crohn’s disease symptoms recorded over 7 days and investigator recorded assessments of the participant’s condition, laboratory parameters and use of anti-diarrhoeal medication. Both participants and investigators made their entries via IVRS each evening before going to bed. Percentage of participants with CDAI decrease from baseline of >=100 points was presented.|At Week 8 and 12|Intent to treat population||Percentage of participants||95% Confidence Interval|Number
835308|NCT01277666|Secondary|Percentage of Participants With CDAI Remission at Week 12|CDAI is a recognized scoring system to categorize disease severity with scores of >= 220 to <= 450 describing the moderately-to-severely active population. Clinical remission is defined as a CDAI score < 150 points if baseline CDAI is >= 150. If baseline CDAI is <150, the participant was not considered in remission. Participants with missing CDAI scores were considered not in remission according to the missing=no effect imputation. Percentage of participants in clinical remission at Week 12 was presented.|Week 12|Intent to treat population.||Percentage of participants||95% Confidence Interval|Number
835355|NCT01286805|Secondary|Requirement of Antiemetic Rescue|The number of participants who needed medication to treat their nausea and vomiting.|Day of surgery prior to discharge|||participants|||Number
835356|NCT01286805|Secondary|Incidence of Vomiting|The number of participants who vomited.|Day of surgery prior to discharge|||participants|||Number
835309|NCT01277666|Primary|Percentage of Participants With Crohn’s Disease Activity Index (CDAI) Response at Week 12|CDAI is a number which consists of information collected from a 7-day diary from the participants regarding symptoms. Remission is considered a score of 150 or less. Active disease is considered 200 or greater. A response to therapy is considered a decline in CDAI score of 70-points from baseline. The score was algorithmically derived from the sum of participant reported Crohn’s disease symptoms recorded over 7 days and investigator recorded assessments of the participant’s condition, laboratory parameters and use of anti-diarrhoeal medication. CDAI score was calculated based on the data collected in the diary card. The total CDAI score ranged from 0 to approximately 600, where higher scores indicate more severe disease. Both participants and investigators made their entries via IVRS each evening before going to bed. Percentage of participants with CDAI response at Week 12 was presented.|Week 12|The intent to treat population comprised of all participants randomized to double-blind treatment for 12 weeks.||Percentage of participants||95% Confidence Interval|Number
835310|NCT01277718|Primary|Maximum Observed Concentration of Cobimetinib||Day 1 at 0 hour (predose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 hours postdose|Pharmacokinetic parameters populations included all enrolled participants. Here, number of participants analyzed = participants who were evaluable for this outcome.||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
835311|NCT01277718|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of Cobimetinib|AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf).|Day 1 at 0 hour (predose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 hours postdose|Pharmacokinetic parameters populations included all enrolled participants. Here, number of participants analyzed = participants who were evaluable for this outcome.||nanograms*hours/milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
835312|NCT01277757|Primary|Number of Participants With Objective Response|Only those participants who have measurable disease present at baseline, have received at least four doses of MK2206, and have had their disease re-evaluated will be considered evaluable for response. Response classified according the RECIST definitions, and re-evaluated for response every 12 weeks. (Note: Participants who exhibit objective disease progression prior to receiving four doses of therapy will also be considered evaluable.) In addition to a baseline scan, confirmatory scans should also be obtained 4-6 weeks following initial documentation of objective response, and then revert to scheduled repeat imaging.|4 weeks following beginning treatment, repeat confirmation 4-6 weeks following response, up to 1 year|Two participants were not treated therefore excluded from study population analysis, another was inevaluable and six others were not analyzable for response.||participants|||Number
835313|NCT01277757|Secondary|Apoptosis Assessed by Cleaved Caspase-3|Assessment of apoptosis by immunohistochemistry to active caspase-3.|Up to 30 days after completion of study treatment, up to 1 year||||||
835314|NCT01277757|Secondary|Cell Proliferation as Measured by the Change in Percent Ki-67 Positive Cells|Ki-67 will be scored as % positive cells to determine whether there is a change % Ki-67+ cells before treatment versus after 2 weeks of treatment.|Baseline to 2 weeks||||||
835315|NCT01277757|Secondary|Median Response Duration|"The duration of the response is from the time response is achieved until disease progression is detected. The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The duration of overall CR is measured from the time measurement criteria are first met for CR until the first date that progressive disease is objectively documented.
Response re-evaluated every 12 weeks. In addition to a baseline scan, confirmatory scans should also be obtained 4-6 weeks following initial documentation of objective response."|Response assessment 4 weeks from beginning of treatment, response recorded from the start of treatment until disease progression/recurrence, up to 1 year|Two participants were not treated, and one was inevaluable.||months||Full Range|Median
835316|NCT01277757|Secondary|6 Month Progression-free Survival (PFS)|Number of participants progression free at 6 months. PFS is defined as the duration of time from start of treatment, or time of progression or death, whichever occurs first. The PFS for this outcome was assessed at 6 months post treatment.|From start of treatment to time of progression or death or six months whichever occurs first, assessed at 6 months|||participants|||Number
835317|NCT01277757|Primary|Number of Participants With Response Defined Using Response Evaluation Criteria In Solid Tumors (RECIST)|Number of participants with response defined by RECIST version 1.1: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: appearance of one or more new lesions is also considered progressions). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|Up to 3 weeks after completion of study treatment, for up to 1 year|Two participants were not treated therefore excluded from study population analysis, another was inevaluable and six others were not analyzable for response.||participants|||Number
835318|NCT01283464|Primary|Global Photodamage Severity|A photonumeric scale for the assessment of cutaneous photodamage (CE Griffiths, et al). Five photographic standards (en face and 45 degrees oblique) illustrating increasing severity of photodamage (min=0, max=8) where 0=no damamge; 2=mild damage; 4=moderate damage; 6=moderate/severe damage; and grade 8=severe damage.|Week 24|||units on a scale||Standard Deviation|Mean
835319|NCT01283516|Primary|Duration of Response (DOR) Based on Investigator Assessment|As per Kaplan-Meier estimate. Duration of response (DOR) is defined as the time from first documented response (partial response (PR) or complete response (CR)) to the date of first documented disease progression (PD) or death due to any cause, among patients with a confirmed PR or CR per RECIST 1.0.|33 months|Subset of Full Analysis Set including ALK-positive NSCLC patients who received at least one dose of LDK378 in the 750 mg dose group and received prior crizotinib and had a confirmed overall complete response or partial response after initiation of LDK378.||Months||95% Confidence Interval|Median
835320|NCT01283516|Primary|Overall Response Rate (ORR) Based on Investigator Assessment|Overall response rate (ORR) is defined as the percentage of participants with a best overall complete response (CR) or partial response (PR) per RECIST 1.0. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI, CR is the disappearance of all target lesions. PR is at least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters. Both CR and PR had to be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met. CR = at least two determinations of CR, at least 4 weeks apart before progression. PR = at least two determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR).|33 months|Subset of Full Analysis Set including ALK-positive NSCLC patients who received at least one dose of LDK378 in the 750 mg dose group and received prior crizotinib||Percentage of Participants||95% Confidence Interval|Number
835321|NCT01283516|Primary|Number of Participants With Dose Limiting Toxicities (DLTs)|The maximum tolerated dose (MTD) was defined as the highest dose for a given schedule that was expected to cause DLTs in no more than 33% of patients during the first cycle of treatment. A patient with multiple occurrences of a DLT under one treatment is counted only once in the AE category for that treatment. MTD was determined at 750mg.|33 months|Dose-determining Set (DDS) consists of all patients (NSCLC and non-NSCLC) from the safety set who either meet the minimum exposure criterion and have sufficient safety evaluations or have experienced a dose limiting toxicity (DLT) during Cycle 1 (including the PK run-in period). This constitutes all evaluable patients for the determination of MTD.||Participants|||Number
835322|NCT01283516|Secondary|Absorption and Plasma Concentrations of LDK378||120 weeks||05/2017||||
835323|NCT01283516|Secondary|Type and Category of Study Drug Related Adverse Events||120 weeks||05/2017||||
835324|NCT01283555|Secondary|Number of Participants Reporting That They Would Recommend the User-filled Applicator for HIV Prevention|"Participants were asked if they would recommend the user-filled applicator to other women if it came with a gel that helped prevent HIV infection.
Response categories included yes, no, and in some circumstances."|Final study visit (after completing both study arms)|All participants were included in the analysis.||participants|||Number
835325|NCT01283555|Secondary|Number of Participants Reporting That They Would Not Want to Use the User-filled Applicator in the Future if it Came With a Gel for HIV Prevention|"Participants were asked if there were any reasons that they would not want to use this user-filled applicator in the future if it came with a gel that helped prevent HIV infection.
Response categories included yes, no, and in some circumstances."|Final study visit (after completing both study arms)|All participants were included in the analysis.||participants|||Number
835326|NCT01283555|Secondary|Number of Participants Reporting That They Would Use the User-filled Applicator in the Future if it Came With a Gel for HIV Prevention|"Participants were asked if they would use the user-filled applicator in the future if it came with a gel that helped prevent HIV infection.
Response categories included yes, no, and in some circumstances."|Final study visit (after completing both study arms)|All participants were included in the analysis.||participants|||Number
835327|NCT01283555|Primary|Number of Colposcopic Findings (Baseline and After One Week of Product Use)|Comparison of colposcopic findings between baseline visits and after one week of twice-daily application of Tenofovir 1% gel with either a user-filled or prefilled applicator|7 days|The number of participants for analysis was determined by counting the number of participants with colposcopic findings and baseline and after one week of product use.||colposcopic findings|Participants||Number
835328|NCT01283555|Secondary|Number of Participants Reporting That the Cost of the Applicator Would Influence Their Choice of Applicator|"Participants were asked if the cost of the applicator would influence their choice of applicator.
Response categories were yes, no, and maybe."|Final study visit (after completing both study arms)|All participants were included in the analysis.||participants|||Number
835329|NCT01283555|Secondary|Number of Participants Reporting That Both Applicators Were Acceptable|"Participants were asked if both applicators were acceptable to them. Responses were either yes or no."|Final study visit (after completing both study arms)|All participants were included in the analysis.||participants|||Number
835330|NCT01283555|Secondary|Number of Participants Reporting That the Instructions for Use Were Helpful|"For each applicator type, participants were asked if the instructions were helpful to you.
Response categories were yes and no."|Final study visit (after completing both study arms)|All participants were included in the analysis.||participants|||Number
835331|NCT01283555|Secondary|Number of Participants Reporting Suggestions Regarding Ease of Use or Comfort|"Participants were asked if they could suggest ways that would make each applicator easier or more comfortable to use. Response categories were yes and no. If yes, participants were asked to describe how they would make the applicator easier and/or more comfortable to use."|Final study visit (after completing both study arms)|All participants were included in the analysis.||participants|||Number
835332|NCT01283555|Secondary|Number of Participants Reporting That Applicator Was Comfortable to Use|"Participants were asked to describe the comfort of use for each applicator type(user-filled and prefilled).
Response categories included comfortable, neutral, and uncomfortable."|Final study visit (after completing both study arms)|All participants were included in the analysis.||participants|||Number
835333|NCT01283555|Secondary|Number of Participants Reporting Applicator Preference (User-filled or Prefilled) Across a Variety of Factors|"Participants were asked about their preference for either the user-filled or prefilled applicator with regard to several use factors as well as in relation to disposal, storage, and overall comfort and preference.
Response categories included user-filled, prefilled, and same."|Final study visit (after completing both study arms)|All participants were included in the analysis.||responses|||Number
835334|NCT01283555|Secondary|Number of Participants Reporting That the Gel Was Easy to Dispense|"Participants were asked to describe the dispensing of the gel into the vagina with each applicator (user-filled and prefilled).
Response categories included easy, moderately difficult, and difficult."|Final study visit (after completing both study arms)|All participants were included in the analysis.||participants|||Number
835335|NCT01283555|Secondary|Number of Participants Reporting Applicator Easy to Insert|"Participants were asked to describe the insertion of the applicator into the vagina for each applicator (user-filled and prefilled).
Response categories included easy, moderately difficult, and difficult."|Final study visit (after completing both study arms)|All participants were included in the analysis.||participants|||Number
835336|NCT01283555|Secondary|Reasons Given by Participants for Knowing When the Applicator Was Filled Correctly|"Participants were asked how did they know when the applicator was filled correctly (that is, with the right amount of gel). More than one answer was allowed.
Response categories included plunger automatically stopped, the 'FULL' line was reached, and other.
Note: this question does not apply to the prefilled applicator."|Final study visit (after completing both study arms)|All participants were included in the analysis. Each participant could identify multiple reasons. As a result, the number of units analyzed is greater than the number of participants.||participants|Participants||Number
835337|NCT01283555|Secondary|Number of Respondents Reporting Confidence With Filling the User-filled Applicator|"Participants were asked when using the user-filled applicator, how confident did they feel that they at inserted the correct amount of gel into the applicator.
Response categories included very confident, confident, and not confident.
(Note: this question does not apply to the prefilled applicator.)"|Final study visit (after completing both study arms)|All participants were included in the analysis.||participants|||Number
835338|NCT01283555|Secondary|Number of Participants Reporting Applicator Easy to Fill|"Participants were asked to describe the process of filling the user-filled applicator.
Response categories included easy, moderately difficult, and difficult.
Since ease of filling only applies to the user-filled applicator, this question was not applicable for the prefilled applicator."|Final study visit (after completing both study arms)|All participants were included in the analysis.||participants|||Number
835339|NCT01283555|Secondary|Dosing Accuracy (% of Target Dose Delivered)|The target dose for Tenofovir gel in this study was 4.0ml, which is the volume of Tenofovir being used in current microbicide clinical trials. The average dose delivered for each applicator was compared with the intended target dose of 4.0ml.|3 dose delivery measurements during 1 week of product use|Per protocol all participants were included in the analysis.||percent of target dose delivered|Participants||Number
835340|NCT01283555|Secondary|Dosing Precision, 10% (Expressed Volume)|A 10% range was calculated around the average expressed volume of 3.83ml to determine how many applicators delivered a dose within this range (+/-10% of average volume)|3 dose delivery measurements during 1 week of product use|Per protocol all participants were included in the analysis.||doses|Participants||Number
835341|NCT01283555|Secondary|Dosing Precision, 5% (Expressed Volume)|A 5% range was calculated around the average expressed volume of 3.83ml to determine how many applicators delivered a dose within this range (+/-5% of average volume)|3 dose delivery measurements during 1 week of product use|Per protocol all participants were included in the analysis.||doses|Participants||Number
835342|NCT01283555|Secondary|Dosing Volume (Expressed Volume)|At each dose delivery visit, the applicator was weighed prior to vaginal insertion and after use. The volume of gel expressed was measured using the following data: weight of filled applicator, weight of emptied applicator, the average weight of an empty applicator, and gel density.|3 dose delivery measurements during 1 week of product use|Per protocol, all participants were included in the analysis.||ml|Participants|Standard Deviation|Mean
835343|NCT01283555|Secondary|Filling Accuracy (% of Target Dose)|The target dose for Tenofovir gel in this study was 4.0ml, which is the volume of Tenofovir being used in current microbicide clinical trials. The filled volume for each applicator was compared with the intended target dose of 4.0ml.|3 dose delivery measurements during 1 week of product use|Per protocol all participants were included in the analysis.||% of target dose filled into applicator|Participants||Number
835344|NCT01283555|Secondary|Filling Precision (10% Range)|A 10% range was calculated around the average filled volumes to determine how many applicators were filled within this range (+/-10% of average volume)|3 dose delivery measurements during 1 week of product use|Per protocol all participants were included in the analysis.||doses|Participants||Number
835345|NCT01283555|Secondary|Filling Precision (5% Range)|A 5% range was calculated around the average filled volumes to determine how many applicators were filled within this range (+/-5% of average volume)|3 dose delivery measurements during 1 week of product use|Per protocol all participants were included in the analysis.||doses|Participants||Number
835346|NCT01283555|Secondary|Filled Volume|At each dose delivery visit, the applicator was weighed, prior to vaginal insertion. For the user-filled applicator, the participant handed the applicator to the investigator after filling with gel from the multidose tube. The applicator was then weighed and returned to the participant for insertion. For the prefilled applicator, the participant inserted the plunger into the barrel, and then handed the applicator to the investigator for weighing.|3 dose delivery measurements during 1 week of product use|Per protocol all participants were included in the analysis.||ml|Participants|Standard Deviation|Mean
835347|NCT01283581|Secondary|Clinical Response Rate in Subjects With Infections Caused by MRSA||up to Late Follow-up||||||
835348|NCT01283581|Secondary|Microbiological Response Rate in All Subjects and in Subjects With Infections Caused by MRSA||up to Late Follow-up||||||
835349|NCT01283581|Secondary|The Levels of Biochemical Markers of Inflammation||on Days 1, 5, Follow-up, and late Follow-up||||||
835350|NCT01283581|Secondary|Steady State Pharmacokinetic Parameters in Subjects Administered Delafloxacin, Vancomycin, and Linezolid||Through Day 3 (± 1 day)||||||
835351|NCT01283581|Secondary|Erythema Clinical Success|The number of ITT subjects who had cessation of erythema within 48-72 hours, based on digital measurements, as well as resolution/absence of fever. Cessation was defined as a percentage change from baseline in total area of erythema/induration that is less than or equal to 0%.|48 - 72 hours|ITT (intent-to-treat) population, defined as all subjects who were randomized.||Participants|||Number
835352|NCT01283581|Primary|Investigator's Assessment of Clinical Response in the ITT (Intent-to-treat) Population at Follow-up and Late Follow-up.|The primary efficacy endpoint was the success rate, defined as (cure)/(cure + failure), and expressed as a percentage. Cure was defined as the complete resolution of all baseline signs and symptoms of ABSSSI and follow-up and late follow-up. If erythema was the only sign of infection present at follow-up and it was then absent at late follow-up, the case was classified as a Cure.|Follow-up (Day 14 ± 1) and late follow-up (Day 21-28)|ITT (intent-to-treat) population, defined as all subjects who were randomized.||Participants|||Number
835353|NCT01286805|Secondary|Quality of Recovery (QoR-40) Physical Comfort Dimension|Assessment of Physical Comfort (minimum score = 12, maximum score = 60). Higher values represent a better outcome|First 24 hours after surgery|||QoR-40 Physical Comfort score||Standard Deviation|Mean
835354|NCT01286805|Secondary|Patient Satisfaction|Patient Satisfaction (0-10; 0 = very dissatisfied, 10 = very satisfied)|First 24 hours after surgery|||units on a scale||Standard Deviation|Mean
835359|NCT01286805|Secondary|Readiness to Discharge From Post-Anesthesia Care Unit (PACU)|Time to readiness for discharge from the PACU. Patients were considered ready for PACU discharge when they met the following criteria: a) Awake, alert, oriented and responsive b) Minimal pain, Numeric Rating Scale < 5/10 (0 = no pain, 10 = worst imaginable pain) (parenteral [injected] medications not required) c) Vital signs stable d) No active bleeding e) Minimal or no nausea f) Not vomiting, tolerating oral intake g) Oxygen saturation > 94% (or baseline) on room air h) Patient has urinated.|Day of surgery prior to discharge|||minutes||Standard Deviation|Mean
835360|NCT01286805|Primary|Numeric Rating Scale (NRS) Pain at Rest (0-10) on Day of Surgery Prior to Discharge|The Numeric Rating Scale was used to ask patients to rate their pain at rest on a scale of 0 to 10, 0 = no pain and 10 = worst pain imaginable.|Day of surgery prior to discharge|||units on a scale||Standard Deviation|Mean
835361|NCT01286818|Secondary|Best Overall Response [Anti-Tumor Activity of FOLFIRI Plus Ramucirumab (IMC-1121B)]|Best overall response evaluated using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) criteria. Complete Response (CR): disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 millimeters (mm). Partial Response (PR): at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter. Progressive Disease (PD): an increase of at least 20% in the sum of the diameters of target lesions, taking as reference the smallest sum on study (included baseline sum if that was the smallest on study). In addition, the sum must have demonstrated an absolute increase of at least 5 mm (the appearance of 1 or more new lesions was considered progression). Stable Disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started.|Every 8 weeks until PD (up to 49 weeks)|Safety population: Participants who received any quantity of study medication.||participants|||Number
835362|NCT01286818|Secondary|Steady State Volume of Distribution (Vss) of Ramucirumab|Vss is the theoretical volume in which the total amount of study drug would need to be uniformly distributed during steady state to produce the same concentration as it is in plasma/serum.|Day 1, Cycle 1 and Day 1, Cycle 5 (1 cycle=14 days)|Participants who received any quantity of study medication and had evaluable Vss data at the specified time points.||Liters (L)||Geometric Coefficient of Variation|Geometric Mean
835363|NCT01286818|Secondary|Clearance (CL) of Ramucirumab|The total body CL of ramucirumab on Day 1, Cycle 1 and on Day 1, Cycle 5, which was also considered CL at steady state (CLss), is reported.|Day 1, Cycle 1 and Day 1, Cycle 5 (1 cycle=14 days)|Participants who received any quantity of study medication and had evaluable CL data at the specified time points.||milliliters per hour (mL/hr)||Geometric Coefficient of Variation|Geometric Mean
835364|NCT01286818|Secondary|Half Life (t1/2) of Ramucirumab|t1/2 is the time required for the plasma/serum concentration to decrease 50%.|Day 1, Cycle 1 and Day 1, Cycle 5 (1 cycle=14 days)|Participants who received any quantity of study medication and had evaluable t1/2 data at the specified time points.||days||Geometric Coefficient of Variation|Geometric Mean
835365|NCT01286818|Secondary|Area Under the Curve (AUC) of Ramucirumab|Reported for Day 1, Cycle 1 is AUC from time 0 extrapolated to infinity [AUC(0-inf)] and for Day 1, Cycle 5 is AUC over the dosing interval at steady state AUC(tau,ss).|Day 1, Cycle 1 and Day 1, Cycle 5 (1 cycle=14 days)|Participants who received any quantity of study medication and had evaluable AUC data at the specified time points.||micrograms*day/milliliter (mcg*day/mL)||Geometric Coefficient of Variation|Geometric Mean
835366|NCT01286818|Secondary|Maximum Concentration (Cmax) of Ramucirumab|The Cmax of ramucirumab in serum on Day 1, Cycle 1 and on Day 1, Cycle 5, which was also considered Cmax at steady state (Cmax,ss), is reported.|Day 1, Cycle 1 and Day 1, Cycle 5 (1 cycle=14 days)|Participants who received any quantity of study medication and had evaluable Cmax data at the specified time points.||micrograms per milliliter (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
835367|NCT01286818|Secondary|Number of Participants With Serum Anti-IMC-1121B Antibodies (Immunogenicity)||Day 1 of Cycle 5 (Week 9), Cycle 6 (Week 11), Cycle 7 (Week 13), and Cycle 9 (Week 17) [(1 cycle=14 days)]|Participants who received any quantity of study medication and had evaluable immunogenicity data at the specified time points.||participants|||Number
835368|NCT01286818|Primary|Number of Participants With Ramucirumab Drug-Related Adverse Events or Serious Adverse Events|Data are presented for the number of participants who experienced treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), Grade ≥3 TEAEs, or adverse events (AEs) leading to discontinuation of treatment that were considered to be related to ramucirumab. Events related to Irinotecan, Levofolinate, and 5-fluorouracil (5-FU) were reported separately. A summary of SAEs and other nonserious AEs, regardless of causality, is located in the Reported Adverse Events section.|Baseline to end of study (up to 49.3 weeks) plus 37 day follow-up|Safety population: Participants who received any quantity of study medication.||participants|||Number
835369|NCT01286818|Primary|Number of Participants That Experienced Any Dose-Limiting Toxicities (DLT) During the DLT Assessment Period|DLTs were adverse events (AEs) possibly related to study drug that met the National Cancer Institute's Common Terminology Criteria for AEs (NCI CTCAE, version 4.03): Grade 4 neutropenia ≥7 days or ≥Grade 3 with bacteremia or sepsis; Absolute neutrophil count <1.0x10^9/Liters with fever ≥38.3°Celsius requiring intravenous antibiotic therapy; Grade 4 thrombocytopenia or ≥Grade 3 with bleeding requiring platelet transfusion; ≥Grade 3 altered coagulation tests and no anticoagulation; ≥Grade 4 or uncontrolled hypertension; ≥Grade 3 non-hematologic toxicity (except non-clinically significant Grade 3 events like electrolyte abnormality, hypersensitivity, and arthralgia/myalgia); urine protein >3 grams/24 hours; study drug-related toxicity causing Cycle 3, Day 1 treatment delay until Day 44 or later. Grade 3 or Grade 4 infusion-related reaction (hypersensitivity) due to ramucirumab or FOLFIRI, not a DLT.|Day 1, Cycle 1 through Day 1, Cycle 3 (1 cycle=14 days)|DLT population: All enrolled participants who either completed the first 3 administrations of study medication or discontinued study medication due to a DLT during the DLT assessment period (Day 1, Cycle 1 through Day 1, Cycle 3).||participants|||Number
835370|NCT01287039|Secondary|Participants With a Positive Anti-Reslizumab Antibody Status During Study|The immunogenicity of reslizumab was assessed by measuring for the presence of anti-reslizumab antibodies at baseline, weeks 16, 32, 48, and 52 or early withdrawal. Blood samples for anti-reslizumab antibodies assessment were also obtained from all patients (inside or outside of the US) experiencing a serious adverse event, an adverse event leading to withdrawal, or an exacerbation of asthma symptoms.|Weeks 16, 32, 48 and 52|Safety analysis set. Immunogenicity for anti-reslizumab antibodies not reported for the placebo treatment arm.||participants|||Number
835371|NCT01287039|Secondary|Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Vital Signs Values|"Data represents participants with potentially clinically significant (PCS) vital sign values.
Significance criteria
Sitting pulse - high 12-17 yr: >100 and increase of >= 30 beats/minute (bpm)
Sitting pulse - low >=18 yr: <50 and decrease of >=30 bpm
Sitting pulse - high >=18 yr: >100 and increase of >=30 bpm
Sitting systolic blood pressure - low >=18 yr: <90 and decrease of >=30 mmHg
Sitting systolic blood pressure - high >=18 yr: >160 and increase of >=30 mmHg
Sitting diastolic blood pressure - low 12-17 yr: <55 and decrease of >=12 mmHg
Sitting diastolic blood pressure - low >=18 yr: <50 and decrease of >=12 mmHg
Sitting diastolic blood pressure - high >=18 yr: >100 and increase of >=12 mmHg
Respiratory rate >=18 yr: >24 and increase of >=10 breaths/minute
Body temperature - low 12-17 yr: <96.5° Fahrenheit or <35.8° Celsius
Body temp - low >=18 yr: <96.5° F or <35.8° C
Body temp - high >=18 yr: >100.5° Fahrenheit"|Week 4 to Week 65. The last postbaseline value for approximately 20 patients in each|Safety analysis set||participants|||Number
835372|NCT01287039|Secondary|Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Abnormal Lab Values|"Data represents participants with potentially clinically significant (PCS) abnormal serum chemistry, hematology, and urinalysis values.
Significance criteria:
Blood urea nitrogen: >=10.71 mmol/L
Uric acid: M>=625, F>=506 μmol/L
Aspartate aminotransferase: >=3*upper limit of normal (ULN). Normal range is 10-43 U/L
Alanine aminotransferase: >=3*ULN. Normal range is 10-40 U/L
GGT = gamma-glutamyl transpeptidase: >= 3*ULN. Normal range is 5-49 U/L.
Bilirubin: >=34.2 μmol/L
White blood cells: <=3.0 or >20 10^9/L
Hemoglobin: M<=115, F<=95 g/dL
Hematocrit: M<0.37, F<0.32 L/L
Neutrophils: <=1.0 10^9/L
Eosinophils: >10.0 %
Platelets: <75 or >=700 10^9/L
Urinalysis: blood, glucose, ketones and total protein: >=2 unit increase from baseline"|Week 4 to Week 65. The last postbaseline value for approximately 20 patients in each|Safety analysis set||participants|||Number
835373|NCT01287039|Primary|Frequency of Each of the Two Criteria for Clinical Asthma Exacerbations (CAEs)|"An exacerbation event was considered a CAE if the patient met either or both of the criteria listed below and this was corroborated with at least 1 other measurement to indicate the worsening of clinical signs and symptoms of asthma:
use of systemic, or an increase in the use of inhaled, corticosteroid treatment for 3 or more days; or an increased 2 or more fold for at least 3 or more days for patient's already on corticosteroids.
asthma-related emergency treatment, such as an unscheduled visit to the physician’s office or emergency room for nebulizer treatment or other urgent treatment to prevent worsening of asthma symptoms, or an asthma-related hospitalization.
CAEs were adjudicated by committee to assure consistency. Adjusted CAE rate and confidence intervals for the two criteria were based on Negative Binomial regression model adjusted for stratification factors.
Results are offered as adjusted means."|Day 1 to Week 52|Randomized set||CAEs in 52 weeks||95% Confidence Interval|Mean
835374|NCT01287039|Secondary|Participants With Treatment-Emergent Adverse Events|An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an inability to carry out usual activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 (post-dose) to Week 65. The last postbaseline value for approximately 20 patients in each|Safety analysis set||participants|||Number
835375|NCT01287039|Secondary|Change From Baseline in Blood Eosinophil Count Over 16 Weeks and 52 Weeks Using Mixed Model for Repeated Measures|"Blood eosinophil counts were measured using a standard complete blood count (CBC) with differential blood test at each scheduled visit, and from all patients experiencing a serious adverse event, an adverse event leading to withdrawal, or an exacerbation of asthma symptoms.
The during treatment average eosinophil counts were estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.
Negative change from baseline values correlate to reduced asthma severity."|Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 or early withdrawal|Randomized set of participants with assessments within timeframe||10^9 blood eosinophil/L||Standard Error|Least Squares Mean
835376|NCT01287039|Secondary|Change From Baseline in Short-Acting Beta-Agonist (SABA) Use Over 16 Weeks Using Mixed Model for Repeated Measures|"SABA are used for quick relief of asthma symptoms. To measure SABA use, at each clinical visit patients were asked to recall their usage of SABA therapy within the last 3 days of the scheduled visit. If usage was confirmed, the number of puffs used was recorded. For the purpose of summaries, an average daily usage was evaluated by dividing the total number of puffs recorded over 3 days by 3.
The during treatment (Weeks 4, 8, 12 and 16) SABA use was estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.
Negative change from baseline scores indicate improvement in asthma control."|Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16|Randomized set of participants with assessments within the timeframe||puffs/day||Standard Error|Least Squares Mean
835377|NCT01287039|Secondary|Change From Baseline in Asthma Symptom Utility Index (ASUI) Over 16 Weeks Using Mixed Model for Repeated Measures|"The ASUI is an 11-item instrument designed to assess the frequency and severity of asthma symptoms and side effects, weighted by patient preferences (Revicki et al 1998). ASUI is a utility score that ranges from 0 to 1, with higher values indicating better asthma control; info obtained from questionnaire about asthma symptoms.
The during treatment (Weeks 4, 8, 12 and 16) average ASUI was estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.
Positive change from baseline values indicate improvement in asthma symptoms. Information was obtained from questionnaire about asthma symptoms."|Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16|Randomized set, including participants who contributed at least once to the analysis.||units on a scale||Standard Error|Least Squares Mean
835511|NCT01288443|Secondary|Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Week 12 - On-Treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|Baseline to Week 12 (LOCF)|mITT population.||mg/dL||Standard Error|Least Squares Mean
835378|NCT01287039|Secondary|Kaplan-Meier Estimates for Time to First Clinical Asthma Exacerbation (CAE)|"An exacerbation event was considered a CAE if the patient met either or both of the criteria listed below and this was corroborated with at least 1 other measurement to indicate the worsening of clinical signs and symptoms of asthma:
use of systemic, or an increase in the use of inhaled, corticosteroid treatment for 3 or more days; or an increased 2 or more fold for at least 3 or more days for patient's already on corticosteroids.
asthma-related emergency treatment, such as an unscheduled visit to the physician’s office or emergency room for nebulizer treatment or other urgent treatment to prevent worsening of asthma symptoms, or an asthma-related hospitalization.
CAEs were adjudicated by committee to assure consistency. The distributions were compared by a log rank test stratified by baseline usage of oral corticosteroid (yes or no) and geographical region (US or other)."|Day 1 to Day 478 (longest treatment time plus 2 weeks)|Randomized set||weeks||95% Confidence Interval|Median
835379|NCT01287039|Secondary|Change From Baseline in Asthma Control Questionnaire (ACQ) Over 16 Weeks Using Mixed Model for Repeated Measures|"The ACQ is a 7-item instrument that measures asthma control (Juniper et al 1999). Six questions are self-assessments; the seventh item, completed by a member of the study staff, is the result of the patient's FEV1 measurement. Each item has 7 possible answers on a scale of 0 to 6, and the total score is the mean of all responses (the total scale is therefore 0-6). A higher score is an indication of poorer asthma control. The during treatment (Weeks 4, 8, 12 and 16) average ACQ was estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.
Negative change from baseline scores indicate improvement in asthma control."|Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16|Randomized set, including participants who contributed at least once to the analysis.||units on a scale||Standard Error|Least Squares Mean
835380|NCT01287039|Secondary|Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) to Week 16|"The AQLQ is a 32-item instrument administered as a self-assessment (Juniper et al 1992). The questionnaire is divided into 4 domains: activity limitation, symptoms, emotional function, and environmental stimuli. Patients were asked to recall their experiences during the last 2 weeks and to respond to each question on a 7-point scale (1=severe impairment, 7=no impairment). The overall AQLQ score is the mean of all 32 responses. Five of the activity questions were “patient-specific,” which means that each patient identified and scored 5 activities in which the patient was limited by asthma; these 5 activities were identified at the first visit and retained for all subsequent follow-up visits.
Positive change from baseline scores indicate improvement in quality of life."|Day 1 (baseline, pre-dose), Week 16|Randomized set of patients with assessments at both timepoints||units on a scale||Standard Error|Least Squares Mean
835381|NCT01287039|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Over 16 Weeks Using Mixed Model for Repeated Measures|"FEV1 is a standard measurement of air movement in the lungs of patients with asthma obtained from pulmonary function tests. It is the volume of air expired in the first second of a forced expiration using a spirometer. Positive change from baseline scores indicate improvement in asthma control.
The during treatment (Weeks 4, 8, 12 and 16) average FEV1 was estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements."|Day 1 (baseline, pre-dose), Weeks 4, 8, 12 and 16|Randomized set, including participants who contributed at least once to the analysis.||liters||Standard Error|Least Squares Mean
835382|NCT01287039|Primary|Frequency of Clinical Asthma Exacerbations (CAEs) During 12 Months of Treatment|"An exacerbation event was considered a CAE if the patient met either or both of the criteria listed below and this was corroborated with at least 1 other measurement to indicate the worsening of clinical signs and symptoms of asthma:
use of systemic, or an increase in the use of inhaled, corticosteroid treatment for 3 or more days; or an increased 2 or more fold for at least 3 or more days for patient's already on corticosteroids.
asthma-related emergency treatment, such as an unscheduled visit to the physician’s office or emergency room for nebulizer treatment or other urgent treatment to prevent worsening of asthma symptoms, or an asthma-related hospitalization CAEs were adjudicated by committee to assure consistency.
Adjusted CAE rate and confidence intervals were based on Negative Binomial regression model adjusted for stratification factors.
Results are offered as adjusted means."|Day 1 to Week 52|Randomized set||CAEs in 52 weeks||95% Confidence Interval|Mean
835383|NCT01287065|Secondary|Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, associated with liver injury and impaired liver function defined as alanine aminotransferase >=3 x upper limit of normal (ULN) and total bilirubin >=2 x ULN or international normalised ratio >1.5. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations. Refer to the general AE/SAE module for a list of AEs and SAEs.|From the first dose of the study medication until the Follow-up Visit (up to 18 weeks)|All Subjects Population: all participants who received at least one dose of the study medication.||Participants|||Number
835384|NCT01287065|Secondary|AM and PM Pre-treatment Trough FEV1 on Day 14|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured electronically by spirometry at Day 14. Trough FEV1 is defined as pre-dose (AM and PM) FEV1 measurement taken on Day 14. The analysis was performed using a mixed effects analysis of covariance model with fixed effect terms for treatment and period; and participant baseline, period baseline, gender and age fitted as covariates; and participant as a random effect. Participant 122 received FF/VI 100/25 PM in treatment periods 1 and 3 and contributed twice to the summary of FF/VI 100/25 PM (n=25). Participant 123 received Placebo in treatment periods 2 and 3 and contributed twice to the summary of Placebo (n=23).|Day 14|ITT Population. Only those participants available at the specified time points were analyzed.||Liters||95% Confidence Interval|Least Squares Mean
835512|NCT01288443|Secondary|Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Week 12 - On-Treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|Baseline to Week 12 (LOCF)|mITT population.||mmol/L||Standard Error|Least Squares Mean
835385|NCT01287065|Secondary|Pre-treatment PEF (AM and PM) on Days 1-12.|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants daily in the morning and evening just prior to each dose, using an electronic peak flow meter, throughout the 14-day Treatment Period. Only the averaged daily AM and PM PEF over Days 2 to 12 was analyzed. The analysis was performed using a mixed effect analysis of covariance model with fixed effect terms for treatment and period; baseline PEF AM and PM, gender and age fitted as covariates; and participant as a random effect. Participant 122 received FF/VI 100/25 PM in treatment periods 1 and 3 and contributed twice to the summary of FF/VI 100/25 PM (n=26). Participant 123 received Placebo in treatment periods 2 and 3 and contributed twice to the summary of Placebo (n=24).|From Day 2 up to Day 12|ITT Population. Only those participants available at the specified time points were analyzed.||Liters per minute||95% Confidence Interval|Least Squares Mean
835386|NCT01287065|Primary|Weighted Mean Forced Expiratory Volume in One Second (FEV1) Over 0–24 Hours Post-dose on Day 14|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured electronically by spirometry at Day 14. Weighted mean FEV1 was calculated using the Day 14 24-hour serial FEV1 measurements taken at the following time points: pre-dose (Day 14 evening dose), and 3, 6, 9, 12, 15, 18, 21 and 24 hours post-dose (measured in the evening of Day 15). At each time point, the highest of 3 technically acceptable measurements was recorded. The analysis was performed using a mixed effects analysis of covariance model with fixed effect terms for treatment and period; and participant (par.) baseline, period baseline, gender and age fitted as covariates; and par. as a random effect. Par. 122 received FF/VI 100/25 PM in treatment periods 1 and 3 and contributed twice to the summary of FF/VI 100/25 PM (n=25). Par. 123 received Placebo in treatment periods 2 and 3 and contributed twice to the summary of Placebo (n=20).|Pre-dose on Day 14 to 24 hours post-dose|Intent-to-Treat (ITT) Population: all participants who were randomized and received at least one dose of study medication and provided at least one post-dose peak expiratory flow (PEF) or FEV1 measurement. Only those participants available at the specified time points were analyzed.||Liters||95% Confidence Interval|Least Squares Mean
835387|NCT01287117|Secondary|Percentage of Complete Responders (UAS7 = 0) at Week 12|A complete responder was defined as a participant with a UAS7 score = 0 at Week 12.|Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.||Percentage of participants|||Number
835388|NCT01287117|Secondary|Percentage of Angioedema-free Days From Week 4 to Week 12|The percentage of angioedema-free days from Weeks 4 to 12 was defined as the number of days for which a patient responded “No” to the angioedema question in the daily diary divided by the total number of days with a non-missing diary entry, starting at the Week 4 visit and ending the day prior to the Week 12 visit.|Week 4 to Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.||Percentage||Standard Deviation|Mean
835389|NCT01287117|Secondary|Change From Baseline in the Overall Dermatology Life Quality Index (DLQI) Score at Week 12|The DLQI is a 10-item dermatology-specific health-related quality of life measure. Patients rated their dermatology symptoms as well as the impact of their skin condition on various aspects of their lives on a scale of 0 (Not at all) to 3 (Very much). The overall DLQI is the sum of the responses to the 10 items and ranges from 0 to 30. A lower score indicates a better quality of life. A negative change score indicates improvement.|Baseline to Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.||Units on a scale||Standard Deviation|Mean
835390|NCT01287117|Secondary|Change From Baseline to Week 12 in the Weekly Size of the Largest Hive Score|The weekly size of the largest hive score is the sum of the daily size of the largest hive scores over 7 days and ranges from 0 to 21. The daily size of the largest hive score is assessed twice daily (morning and evening) on a scale of 0 (none) to 3 (> 2.5 cm). The daily size of the largest hive score is the average of the morning and evening scores. The Baseline weekly size of the largest hive score is calculated over the 7 days prior to the first treatment. A higher score indicates larger hives. A negative change score indicates a reduction in hive size.|Baseline to Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.||Units on a scale||Standard Deviation|Mean
835391|NCT01287117|Secondary|Percentage of Weekly Itch Severity Score MID Responders at Week 12|The percentage of participants with an itch severity score at 12 Weeks at least 5 points lower than at Baseline.|Baseline to Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.||Percentage of participants|||Number
835392|NCT01287117|Secondary|Percentage of Participants With a UAS7 Score ≤ 6 at Week 12|The UAS7 is the sum of the daily urticarial activity scores over 7 days and ranges from 0 to 42. The daily urticarial activity score is the average of the morning and evening urticarial activity scores and ranges from 0 to 6. The urticarial activity score is the sum of ratings on a scale of 0 to 3 (0=none to 3=intense/severe) for (1) the number of wheals (hives) and (2) itch intensity over the previous 12 hours, ranges from 0 to 6, and is measured twice daily (morning and evening). The Baseline score is the sum of the daily urticarial activity scores over the 7 days prior to the first treatment. A higher urticarial activity score indicates more urticaria activity.|Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.||Percentage of participants|||Number
835393|NCT01287117|Secondary|Time to Minimally Important Difference (MID) Response in the Weekly Itch Severity Score by Week 12|The time to the MID response is the number of weeks from the start of treatment (Baseline) until the time point at which the first MID response occurs. The MID response is defined as a reduction ≥ 5 points from Baseline in the weekly itch severity score.|Baseline to Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.||Weeks||95% Confidence Interval|Median
835394|NCT01287117|Secondary|Change From Baseline to Week 12 in the Weekly Number of Hives Score|The weekly hives score is the sum of the daily hives scores over 7 days and ranges from 0 to 21. The number of hives is measured twice daily (morning and evening) on a scale of 0 (none) to 3 (> 12 hives per 12 hours). The daily hives score is the average of the morning and evening scores. The Baseline score is the sum of the daily hives scores over the 7 days prior to the first treatment. A higher score indicates more hives. A negative change score indicates improvement.|Baseline to Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.||Units on a scale||Standard Deviation|Mean
835395|NCT01287117|Secondary|Change From Baseline to Week 12 in the Urticaria Activity Score Over 7 Days (UAS7)|The UAS7 is the sum of the daily urticarial activity scores over 7 days and ranges from 0 to 42. The daily urticarial activity score is the average of the morning and evening urticarial activity scores and ranges from 0 to 6. The urticarial activity score is the sum of ratings on a scale of 0 to 3 (0=none to 3=intense/severe) for (1) the number of wheals (hives) and (2) itch intensity over the previous 12 hours, ranges from 0 to 6, and is measured twice daily (morning and evening). The Baseline score is the sum of the daily urticarial activity scores over the 7 days prior to the first treatment. A higher urticarial activity score indicates more urticaria activity. A negative change score indicates improvement.|Baseline to Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.||Units on a scale||Standard Deviation|Mean
835396|NCT01287117|Primary|Change From Baseline to Week 12 in the Weekly Itch Severity Score|The weekly itch severity score is the sum of the daily itch severity scores over 7 days and ranges from 0 to 21. The daily itch severity score is the average of the morning and evening scores on a scale of 0 (none) to 3 (severe). The Baseline weekly itch severity score is the sum of the daily itch severity scores over the 7 days prior to the first treatment. A higher itch severity score indicates more severe itching. A negative change score indicates improvement.|Baseline to Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.||Units on a scale||Standard Deviation|Mean
835397|NCT01287195|Secondary|Score in Histologic Evaluation of Flexible Sigmoidoscopy|Mucosal biopsies were obtained from the most inflamed area seen during flexible sigmoidoscopy and blindly scored by a single pathologist with scores ranging 0-3 with a higher score indicating a worse outcome.|Baseline, Week 5|All participants enrolled in the study for whom data were available at each time point.||score on a scale||Standard Error|Mean
835398|NCT01287195|Secondary|Simple Clinical Colitis Activity Index (SCCAI) Score|SCCAI is a symptom based questionnaire addressing five assessments, including bowel frequency day, bowel frequency night, urgency of defecation, blood in stool and general well-being. Score ranges from 0-15 with one additional point added for each manifestation of extracolonic features. A higher score indicates a worse outcome.|Baseline, Week 5|All participants enrolled in the study for whom data were available at each time point.||score on a scale||Standard Error|Mean
835399|NCT01287195|Secondary|Mayo Score|The Mayo Score is determined by the investigator by assigning a score to the following four assessments: stool frequency, rectal bleeding, physician’s global assessment and endoscopy. Total range for Mayo score is 0-12 with a higher score indicating a worse outcome.|Baseline, Week 5|All participants enrolled in the study for whom data were available at each time point.||score on a scale||Standard Error|Mean
835400|NCT01287195|Primary|Cytokine Production by PBMCs in Cell Culture|Cytokine production was assessed in cell cultures of PBMCs obtained from participants at baseline, Weeks 1, 3 and 5. The following cytokines were detected and are reported here: interferon gamma (IFN-gamma), interleukin (IL)-17A, IL-6, IL-1 beta, tumor necrosis factor (TNF) and IL-10.|Baseline, Weeks 1, 3 and 5|All participants enrolled in the study for whom data were available at each time point.||picograms/milliliter (pg/mL)||Standard Deviation|Mean
835401|NCT01287195|Primary|T Cell Proliferation of PBMCs in Cell Culture|PBMCs isolated from whole blood obtained from participants at baseline, Weeks 1, 3, and 5 were assessed for proliferation in cell culture using a radioactive thymidine incorporation assay. A higher number indicates a higher level of proliferation.|Baseline, Weeks 1, 3 and 5|All participants enrolled in the study for whom data were available at each time point.||radioactive counts of cells per minute||Standard Error|Mean
835402|NCT01287195|Primary|Percentage of Biomarker-positive Immune Cells|Peripheral blood mononuclear cells were (PBMCs) were isolated from blood samples taken from each participant at baseline and Week 5. PBMCs were stained with a panel of fluorochrome-conjugated antibodies against multiple surface and intracellular biomarkers, including Cluster of Differentiation (CD) 3, CD4, CD8, Forkhead box P3 protein (FOXP3) and latency-associated peptide (LAP). The percentage of T cells positive for each of these biomarkers was determined by fluorescence activated cell sorting (FACS) and the mean percentage of positive T cells for each biomarker for all analyzed participants is reported.|Baseline, Week 5|All participants enrolled in the study for whom data were available at both time points.||percentage of biomarker-positive T cells||Standard Deviation|Mean
835403|NCT01287195|Primary|Number of Participants With Anti-Drug Antibodies|Serum samples were obtained to measure anti-drug antibodies during the study.|From baseline to Week 10|All participants enrolled in the study.||Participants|||Count of Participants
835404|NCT01287195|Primary|Number of Participants With Adverse Events|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|From baseline to Week 10|All participants enrolled in the study.||Participants|||Count of Participants
835405|NCT01287208|Secondary|Hours of Sleep Per Night|Number of hours slept per night as recorded on activity device|12 weeks||||||
835406|NCT01287208|Secondary|Weight||12 weeks||||||
835407|NCT01287208|Secondary|Calories Burned Per Day|Total calories burned per day recorded on activity device|12 weeks||||||
835408|NCT01287208|Secondary|Distance Per Day|Distance in miles recorded on activity device|12 weeks||||||
835409|NCT01287208|Primary|Steps Per Day|Steps will be recorded on the activity device|12 weeks|We excluded 4 participants who withdrew prior to randomization and 5 who withdrew after randomization.||steps per day||Inter-Quartile Range|Median
835410|NCT01287221|Secondary|Change in the COMPASS-Select-Change Scale From Baseline to 12 Months|"The change in COMPASS is a derivative of COMPASS and evaluates the change in symptoms over time on selected domains of symptoms as a function of natural history or intervention therapy. The focus is on 7 selected domains. The version of the COMPASS-Change -Select Scale used (06-09-2009 Ver. 1) has 16 questions, with multiple parts, scores ranging from much worse to no such symptoms. The score could range from 0 (no such symptoms) to 94 (much worse)."|baseline, 12 months|Analysis was done using intention to treat principles. Not all patients reached the 12 month time point due to missed visits or the early termination of the study.||units on a scale||Standard Deviation|Mean
835411|NCT01287221|Secondary|Change From Baseline to 12 Months in the COMPASS-Select Scale|"The composite autonomic symptoms score (COMPASS) provides a score of autonomic symptom severity with appropriate weighting. In the COMPASS_select, symptoms are confined to 6 select domains of symptoms. The version of the COMPASS-Select used (06-09-2009 v1) has 46 questions, with multiple parts, scores ranging from much worse to no such symptoms. Scores could range from 0 (no such symptoms) to 85 (much worse)."|baseline, 12 months|Analysis was done using intention to treat principles. Not all patients reached the 12 month time point due to missed visits or the early termination of the study.||units on a scale||Standard Deviation|Mean
835412|NCT01287221|Secondary|Rate of Change From Baseline to 12 Months in Total UMSARS (i.e., UMSARS Part I Minus Question 11 + UMSARS Part II) Using Slope Estimate|"UMSARS is a scale measuring disease progression that comprises 4 parts; only Parts I and II were used in this study. Part I scores symptoms of neurological and autonomic dysfunction. Part II is a motor examination. Part I has 12 questions with a rating scale ranging from 0 (normal) to 4 (extreme dysfunction). Part II has 14 items with a rating scale ranging from 0 (normal) to 4 (extreme dysfunction). Therefore the total score for total UMSARS Parts I minus Question 11 + Part II could range from 0 (normal) to 104 (extreme dysfunction).
Participant-specific rate of change in points per month was estimated using slope estimate from least square regression where for each participant, their total UMSARS scores were plotted over time measured in months."|baseline, 12 months|Analysis was done using intention to treat principles. Not all patients reached the 12 month time point due to missed visits or the early termination of the study.||units on a scale per month||Standard Deviation|Mean
835413|NCT01287221|Secondary|Change From Baseline to 12 Months in Total UMSARS (i.e., UMSARS Part I Minus Question 11 + UMSARS Part II)|UMSARS is a scale measuring disease progression that comprises 4 parts; only Parts I and II were used in this study. Part I scores symptoms of neurological and autonomic dysfunction. Part II is a motor examination. Part I has 12 questions with a rating scale ranging from 0 (normal) to 4 (extreme dysfunction). Part II has 14 items with a rating scale ranging from 0 (normal) to 4 (extreme dysfunction). Therefore the total score for total UMSARS Parts I minus Question 11 + Part II could range from 0 (normal) to 104 (extreme dysfunction).|baseline, 12 months|Analysis was done using intention to treat principles. Not all patients reached the 12 month time point due to missed visits or the early termination of the study.||units on a scale||Standard Deviation|Mean
835414|NCT01287221|Secondary|Change From Baseline to 12 Months in UMSARS Part II|UMSARS is a scale measuring disease progression that comprises 4 parts; only Parts I and II were used in this study. Part I scores symptoms of neurological and autonomic dysfunction. Part II is a motor examination. Part II has 14 items with a rating scale ranging from 0 (normal) to 4 (extreme dysfunction). Therefore the total score for Part II could range from 0 (normal) to 56 (extreme dysfunction).|baseline, 12 months|Analysis was done using intention to treat principles. Not all patients reached the 12 month time point due to missed visits or the early termination of the study.||units on a scale||Standard Deviation|Mean
835415|NCT01287221|Secondary|Change From Baseline to 12 Months in UMSARS Part I Score (Minus Question 11)|UMSARS is a scale measuring disease progression that comprises 4 parts, only Parts I and II were used in this study. Part I scores symptoms of neurological and autonomic dysfunction. Part II is a motor examination. Part I has 12 questions with a rating scale ranging from 0 (normal) to 4 (extreme dysfunction). Therefore the total score for Part I could range from 0 (normal) to 48 (extreme dysfunction).|baseline, 12 months|Analysis was done using intention to treat principles. Not all patients reached the 12 month time point due to missed visits or the early termination of the study.||units on a scale||Standard Deviation|Mean
835416|NCT01287221|Primary|Rate of Change From Baseline to 12 Months in the Total Unified Multiple System Atrophy Rating Scale (UMSARS) Part I Score (Minus Question 11)|"UMSARS is a scale measuring disease progression that comprises 4 parts; only Parts I and II were used in this study. Part I scores symptoms of neurological and autonomic dysfunction. Part II is a motor examination. Part I has 12 questions with a rating scale ranging from 0 (normal) to 4 (extreme dysfunction). Therefore the total score for Part I could range from 0 (normal) to 48 (extreme dysfunction).
Participant-specific rate of change in points per month was estimated using slope estimate from least square regression where for each participant, their UMSARS I scores were plotted over time measured in months."|baseline, 12 months|Analysis was done using intention to treat principles and no imputations were done for any missing values or slope estimates. All randomized participants who took at least two doses of the study drug were included in the principal efficacy analysis. One subject on the Rifampicin arm did not return after the baseline visit.||units on a scale per month||Standard Deviation|Mean
835417|NCT01287364|Primary|Principal Components Analysis (Treatment Process, Treatment Outcomes) Factor Loadings for Treatment Preference Scales|Principal components analysis was conducted with varimax rotation that revealed two factors. These two factors are the principal components of the preference scale: Treatment Process and Treatment Outcomes. Loadings represent the degree each of the variables “correlates” with each of the factors. The loadings range from -1 to 1. An inspection of the factor loadings, reveals the extent to which each of the variables contributes to the meaning of each of the factors. High loading number provide meaning and interpretation of factors.|Day 1 (Pre-treatment) through Day 29|Subjects from Treatment Sequence AB (ciclesonide nasal aerosol 74 mcg/mometasone nasal spray 200 mcg) and Treatment Sequence BA (mometasone nasal spray 200 mcg/ciclesonide nasal aerosol 74 mcg) were pooled. Validation was performed without regard to treatment, thus all observations were pooled.||factor loadings|||Number
835418|NCT01287364|Primary|Sensitivity Analyses of Treatment Satisfaction Subscales: Standard Effect Sizes (SES)|"Within-and between-responder group standardized effect sizes (SES) were calculated. The generally accepted guidelines for clinically important standard effect sizes are “small”(0.2), “medium” (0.5), and “large” (0.8).
Between group SES indicates the magnitude of “treatment” differences. In this case, the groups were responders according to the baseline rTNSS scores. All of the treatment satisfaction subscales and satisfaction scales were scored from 0 (low satisfaction) to 100 (high satisfaction)."|Day 1 (Pre-treatment) through Day 29|Baseline rTNSS was partitioned into tertiles and patients were assigned to Low, Medium, or High symptom groups.||standard effect sizes|||Number
835457|NCT01287741|Secondary|Overall Survival (OS)|Overall survival in the overall study population was defined as the time from the date of randomization to the date of death from any cause. Reported is the percentage of participants with event.|Baseline up to data cut-off (up to approximately 4 years and 9 months)|The intent-to-treat (ITT) population included all randomized participants.||percentage of participants|||Number
835419|NCT01287364|Primary|Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 2 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change)|Analysis was conducted with one-sample t-tests on the treatment satisfaction subscale change scores for Treatment Period 2 against the test criterion of “no change” (ie, change score = 0)TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. TNSS values range from 0-12 (0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. All of the treatment satisfaction subscales and satisfaction scales were scored from 0 (low satisfaction) to 100 (high satisfaction).|Day 1 (pre-treatment) through Day 7 Treatment Period 2|The rTNSS total period 2 change scores were partitioned into tertile ranges to form three groups: Low Change (-0.70 – -1.85; n = 55), Medium Change (-2.08 – -1.74; n = 56), or High Change (-6.57 – -2.14; n = 55).||scores on a scale||Standard Error|Mean
835420|NCT01287364|Primary|Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 1 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change)|Analysis was conducted with one-sample t-tests on the treatment satisfaction subscale change scores for Treatment Period 1 against the test criterion of “no change” (ie, change score = 0)TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. TNSS values range from 0-12 (0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. All of the treatment satisfaction subscales and satisfaction scales were scored from 0 (low satisfaction) to 100 (high satisfaction).|Day 1 (pre-treatment) through Day 7 Treatment Period 1|The rTNSS total period 1 change scores were partitioned into tertile ranges to form three groups: Low Change (-1.04 – -4.93; n = 60), Medium Change (-2.49 – -1.05; n = 62), and High Change (-7.57 – -2.50; n = 61).||scores on a scale||Standard Error|Mean
835421|NCT01287364|Primary|Discriminant Validity of Treatment Satisfaction Subscales Statistical Analyses Based on Baseline Reflective Total Nasal Symptom Score (rTNSS) Categories (Low, Medium, High)|Discriminant validity tests whether the subscales differentiate among groups of respondents that differ on a pre-specified criterion, baseline rTNSS. Patients were assigned to baseline rTNSS categories of Low Symptoms(3.00 – 7.17; n = 62), Medium Symptoms (7.25 – 9.25; n = 61), or High Symptoms (9.33 – 12.00; n = 62). Reflective TNSS group served as the independent variable and the nine treatment satisfaction subscales were evaluated as dependent variables by analysis of variance models. Contrasts were tested between the Low and Medium Symptoms and the High and Low Symptom categories. Reflective TNSS group served as the independent variable and the nine treatment satisfaction subscales were evaluated as dependent variables by analysis of variance models. All of the treatment satisfaction subscales and satisfaction scales were scored from 0 (low satisfaction) to 100 (high satisfaction).|Day 1 (Pre-treatment) through Day 7 Treatment Period 1|Baseline rTNSS was partitioned into tertile ranges and patients were assigned to Low (3.00 – 7.17; n = 62), Medium (7.25 – 9.25; n = 61), or High (9.33 – 12.00; n = 62) symptom groups.||scores on a scale||Standard Error|Mean
835422|NCT01287364|Primary|Treatment Satisfaction Subscales (Interference, Regimen Adaptation, Role Limitations, Sensory Impact, Regimen Difficulties, Burden, Hassle, Regimen Management, and Perceived Relief)Reliability Statistics|Reliability for the nine treatment satisfaction subscales was established through internal consistency statistical analyses [Cronbach’s alpha (raw and standardized) coefficients were calculated]. The correlation coefficients for these analyses ranged from 0.0 to 1.0, with higher coefficients indicating greater reliability. A coefficient of ≥ 0.7 was the standard for evidence of reliability.|Day 1 (Pre-treatment) through Day 7 Treatment Period 2|Subjects from Treatment Sequence AB (ciclesonide nasal aerosol 74 mcg/mometasone nasal spray 200 mcg) and Treatment Sequence BA (mometasone nasal spray 200 mcg/ciclesonide nasal aerosol 74 mcg) were pooled. Validation was performed without regard to treatment, thus all observations were pooled.||ratio of variance|||Number
835423|NCT01287403|Secondary|Phenolic Acids|Phenolic acids in plasma and urine|0-48 h post dose||||||
835424|NCT01287403|Secondary|Plasma and Urinary Betaine||From 0 to 48 hours post dose||||||
835425|NCT01287403|Primary|Plasma Alkylresorcinol Compounds|Area under the curve (AUC) over baseline of alkylresorcinol compounds are measured for the 6 interventional arms. Time points are: t = 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24 and 48 h after product intake.|From 0 to 48 h post dose.|||nmol/L*h||Standard Deviation|Mean
835426|NCT01287416|Secondary|Gatekeeper Behaviours - Did Not Ask Person at Risk|Number of participants who did not ask someone about their suicidal thoughts even though they thought they were at risk, measured at 6 month follow-up assessment based on time since training.|January 28-31, 2011|The smaller number of participants per group reflects the number of individuals who responded to the baseline and 6 month follow up time point questionnaires.||participants|||Number
835427|NCT01287416|Secondary|Gatekeeper Behaviors - Asked Person at Risk About Suicidal Thoughts|Number of participants who have asked someone that they thought was at risk about suicidal thoughts since the training, measured at 6 month follow-up assessment.|January 28-31, 2011|The smaller number of participants per group reflects the number of individuals who responded to the baseline and 6 month follow up time point questionnaires.||participants|||Number
835428|NCT01287416|Secondary|Attempted Suicide Since Training at 6 mo Follow-up|Number of people who endorsed having made a suicide attempt since the training as measured at 6 month follow-up|January 28-31, 2011|The smaller number of participants per group reflects the number of individuals who responded to the 6 month follow up time point questionnaire.||participants|||Number
835429|NCT01287416|Secondary|Suicidal Ideation Since Training at 6 mo Follow-up|Number of people who endorsed having thought about suicide since the training as measured at 6 month follow-up (not at all vs a little to a lot)|January 28-31, 2011|The smaller number of participants per group reflects the number of individuals who responded to the 6 month follow up time point questionnaire.||participants|||Number
835430|NCT01287416|Secondary|Number of People With Suicidal Ideation in Past 2 Days Immediately Post Training|Number of people who endorsed having thought about suicide in the past 2 days as measured immediately post training (not at all vs a little to a lot)|July 22-23, 2010|The smaller number of participants per group reflects the number of individuals who responded to the post-training questionnaire.||participants|||Number
835434|NCT01287416|Secondary|Self-reported Resiliency Score|Assesses resiliency in the participant according to the Connor-Davidson Resilience Scale, 10-item. The CD-RISC 10 is comprised of ten questions scored from 0 (Not at all true) to 4 (True nearly all of the time). The sum of the scores from all ten questions was used to determine a total scale score which ranges from 0 (low resiliency) to 40 (highly resilient).|pre-training and 6 month follow-up|The smaller number of participants per group reflects the number of individuals who responded to the baseline and 6 month follow up time point questionnaires.||Scores on scale||Standard Error|Mean
835435|NCT01287416|Secondary|Self-reported Alcohol Use|Details participants' level of alcohol consumption and if it may be harmful according to the AUDIT. The AUDIT scale is comprised of ten questions with most questions being scored from 0 (never) to 4 (4 or more times per week). The sum of the scores from all ten questions was used to determine a total scale score which ranges from 0 (no risk related to alcohol) to 40 (high risk related to alcohol). Total scores of 8 or more are recommended as indicators of hazardous and harmful alcohol use, as well as possible alcohol dependence.|pre-training and 6 month follow-up|The smaller number of participants per group reflects the number of individuals who responded to the baseline and 6 month follow up time point questionnaires.||Scores on a scale||Standard Error|Mean
835436|NCT01287416|Secondary|Self-reported Distress|Measures the level of distress in the participant using the K6 distress scale. The scale is comprised of six questions which are scored from 0 (none of the time) to 4 (all of the time). The sum of the scores from all six questions was used to determine a total scale score which ranges from 0 (not at all distressed) to 24 (very distressed).|pre-training and 6 month follow-up|The smaller number of participants per group reflects the number of individuals who responded to the baseline and 6 month follow up time point questionnaires.||Scores on a scale||Standard Error|Mean
835437|NCT01287416|Secondary|Self-perceived Preparedness|Measures the level of preparedness of the individual to help someone who is suicidal based on a 4 point Likert scale ranging from 1 (not at all prepared) to 4 (very prepared).|pre-training, post-training and 6 month follow-up|||Scores on a scale||Standard Deviation|Mean
835438|NCT01287416|Secondary|Self-perceived Knowledge About Suicide|Measures the level of knowledge about suicide that the individual believes they have based on a 4 point Likert scale ranging from 1 (not at all knowledgeable) to 4 (very knowledgeable).|pre-training, post-training and 6 month follow-up|||Scores on a scale||Standard Deviation|Mean
835439|NCT01287416|Secondary|Self-perceived Skill in Helping a Suicidal Individual|Measures the level of ability that the individual believes they have in helping a suicidal person based on a 4 point Likert scale ranging from 1 (not at all skilled) to 4 (very skilled).|pre-training, post-training and 6 month follow-up|||scores on a scale||Standard Deviation|Mean
835440|NCT01287416|Secondary|Self-perceived Confidence in Helping a Suicidal Individual|Meaures the level of confidence that the individual believes they have in helping a suicidal person based on a 4 point Likert scale ranging from 1 (not at all confident) to 4 (very confident).|pre-training, post-training and 6 month follow-up|||scores on a scale||Standard Deviation|Mean
835441|NCT01287416|Primary|SIRI Questionnaire Score|The Suicide Intervention Response Inventory (SIRI-2) will be used to detect enhancement of intervention skills in participants. The 25-item SIRI-2 is a self-administered test that was designed to measure competnce in choosing appropriate response to a series of clinical scenarios with suicidal individuals. Research on the SIRI-2 has shown its good psychometric properties, freedom from social desirabiity effects and responsiveness to training in suicide prevention.|pre-training, post-training and 6 mo follow up|||number of items correct||Standard Deviation|Mean
835442|NCT01287611|Secondary|Length of Uterine Incision After Suturing|Length of uterine incision after suturing will be examined and measured by ultrasonography, and two groups will be compared.|6 weeks after C/S|||cm||Standard Deviation|Mean
835443|NCT01287611|Primary|Cesarean Scar Defect in the Uterine Incisional Line|A wedge-shaped distortion in the integrity of the uterine incision scar during transvaginal ultrasonographic examination at 6 weeks after C/S was accepted as cesarean scar defect in the uterine incisional line and recorded as primary outcome measure, and two groups will be compared.|6 weeks after C/S|||participants|||Number
835444|NCT01287741|Secondary|Serum Concentrations of Obinutuzumab in Japanese Participants With Diffuse Large B-Cell Lymphoma (DLBCL)|Serum samples for assessment of obinutuzumab serum concentrations were collected only from a subset of Japanese participants following administration of 1000 mg obinutuzumab.|C1: D1 post-infusion and 20-28 and 66-80 hours after end of infusion, D8 and D15 pre-and post-infusion; C2: D1 pre- and post-infusion; C4: D1 pre- and post-infusion; C6: D1 pre- and post-infusion; C8: D1 pre- and post-infusion (cycle length = 21 days)|40 Japanese participants in the Obinutuzumab+Chemotherapy arm||micrograms per milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
835445|NCT01287741|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ-C30) Domain Scores|The EORTC QLQ-C30 is a health-related quality of life questionnaire. A higher score indicates better quality of life, with changes of 5 to 10 points considered to be a minimally important difference to participants.|Baseline (pre-dose [Hour 0] on C1D1), C3D1, end of treatment (up to Month 6), every 12 months thereafter up to data cut-off, up to approximately 4 years and 9 months, (cycle length = 21 days)|The intent-to-treat (ITT) population included all randomized participants.||score on a scale||Standard Deviation|Mean
835446|NCT01287741|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Subscale Score|The FACT-Lym subscale was developed to assess health-related quality of life in patients with non-Hodgkin lymphoma. The score range is 0-60, with higher scores indicating better outcomes. A positive change from baseline indicates an improvement.|Baseline (pre-dose [Hour 0] on C1D1), C3D1, end of treatment (up to Month 6), every 12 months thereafter up to data cut-off, up to approximately 4 years and 9 months, (cycle length = 21 days)|The intent-to-treat (ITT) population included all randomized participants.||score on a scale||Standard Deviation|Mean
835447|NCT01287741|Secondary|Percentage of Participants With Human Anti-Human Antibodies (HAHAs) to Obinutuzumab|The presence of HAHAs to obinutuzumab was assessed in the first 100 randomized participants.|Pre-dose (Hour 0) on Cycle (C) 1 Day (D) 1, C4D1, at end of treatment/early termination (up to Month 6), every 6 months thereafter for 30 months (cycle length = 21 days)|The safety analysis population included all participants who received at least one dose of study drug.||percentage of participants|||Number
835448|NCT01287741|Secondary|Percentage of Participants With Adverse Events (AEs)|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|Baseline up to data cut-off (up to approximately 4 years and 9 months)|The safety analysis population included all participants who received at least one dose of study drug.||percentage of participants|||Number
835449|NCT01287741|Secondary|Time to Next Anti-Lymphoma Treatment (TTNALT)|Time to next anti-lymphoma treatment was defined as the time from the date of randomization to the start date of the next anti-lymphoma treatment or death from any cause.|Baseline up to start of next anti-lymphoma treatment or death due to any cause, whichever occurred first, to data cut-off (up to approximately 4 years and 9 months)|The intent-to-treat (ITT) population included all randomized participants.||months||95% Confidence Interval|Median
835450|NCT01287741|Secondary|Duration of Response (DOR), Investigator-Assessed|DOR: time from first occurrence of documented CR or PR to disease progression/relapse, or death from any cause for participants with a response of CR or PR. Tumor assessments were performed with CT/MRI. CR: disappearance of all target lesions. PR: >/=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodule regression >/= 50%. Progression/relapse: at least 50% increase in nodal lesions or >/=50% increase in any node > 1 cm or >/= 50% increase in other target lesions (e.g., splenic or hepatic nodules) and/or any new bone marrow involvement and/or any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. A participant in the Rituximab+CHOP arm with the longest follow-up, 53 months, had an event. The criterion for median was the minimum time when survival went below 50%.|Baseline up to death or disease progression, whichever occurs first, to data cut-off (up to approximately 4 years and 9 months)|The intent-to-treat (ITT) population included all randomized participants, of which evaluable participants were included in this analysis.||months||95% Confidence Interval|Median
835451|NCT01287741|Secondary|Disease-Free Survival (DFS), Investigator-Assessed|Disease-free survival was defined as the time from the date of the first occurrence of a documented CR to the date of disease progression/relapse or death from any cause on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI. CR was defined as disappearance of all target lesions. Progression/relapse was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. Reported is the percentage of participants with event.|Baseline up to death or disease progression, whichever occurred first, to data cut-off (up to approximately 4 years and 9 months)|The intent-to-treat (ITT) population included all randomized participants, of which evaluable participants were included in this analysis.||percentage of participants|||Number
835452|NCT01287741|Secondary|Event-Free Survival (EFS), Investigator-Assessed|Event-free survival was defined as the time from the date of randomization until the date of disease progression, relapse, initiation of a new non–protocol-specified anti-lymphoma treatment, or death from any cause on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Disease progression/relapse was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. Tumor measurements were obtained by CT/MRI. Reported is the percentage of participants with event.|Baseline up to death or disease progression, or initiation of new anti-lymphoma treatment (NALT), whichever occurred first, to data cut-off (up to approximately 4 years and 9 months)|The intent-to-treat (ITT) population included all randomized participants.||percentage of participants|||Number
835453|NCT01287741|Secondary|Complete Response (CR) at the End of Treatment, IRC-Assessed|Percentage of participants with complete response was determined on the basis of IRC assessments according to the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma, 2007. Tumor assessments were performed with CT/MRI with or without PET. Complete response was defined as the disappearance of all evidence of disease.|Baseline up to data cut-off (up to approximately 4 years and 9 months)|The intent-to-treat (ITT) population included all randomized participants.||percentage of participants|||Number
835454|NCT01287741|Secondary|Complete Response (CR) at the End of Treatment, Investigator-Assessed|Percentage of participants with complete response was determined on the basis of investigator assessments according to the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma, 2007. Tumor assessments were performed with CT/MRI with or without PET. Complete response was defined as the disappearance of all evidence of disease.|Baseline up to data cut-off (up to approximately 4 years and 9 months)|The intent-to-treat (ITT) population included all randomized participants.||percentage of participants|||Number
835455|NCT01287741|Secondary|Overall Response Rate (ORR), IRC-Assessed|Overall response was determined on the basis of IRC assessments according to the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma, 2007. Tumor assessments were performed with CT/MRI with or without PET. Overall response was defined as the disappearance of all evidence of disease, regression of measurable disease, and no new sites.|Baseline up to data cut-off (up to approximately 4 years and 9 months)|The intent-to-treat (ITT) population included all randomized participants.||percentage of participants|||Number
835456|NCT01287741|Secondary|Overall Response Rate (ORR), Investigator-Assessed|Overall response was determined on the basis of investigator assessments according to the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma, 2007. Tumor assessments were performed with CT/MRI with or without PET. Overall response was defined as the disappearance of all evidence of disease, regression of measurable disease, and no new sites.|Baseline up to data cut-off (up to approximately 4 years and 9 months)|The intent-to-treat (ITT) population included all randomized participants.||percentage of participants|||Number
835458|NCT01287741|Secondary|Progression-Free Survival (PFS), Independent Review Committee (IRC)-Assessed|Progression-free survival was defined as the time from randomization until the first documented day of disease progression or relapse, using a modified version of the Revised Response Criteria for Malignant Lymphoma, or death from any cause, whichever occurred first, on the basis of IRC assessments. Progression was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. Tumor measurements were obtained by computed tomography (CT) or magnetic resonance imaging (MRI).|Baseline up to data cut-off (up to approximately 4 years and 9 months)|The intent-to-treat (ITT) population included all randomized participants.||percentage of participants|||Number
835459|NCT01287741|Primary|Progression-Free Survival (PFS), Investigator-Assessed|Progression-free survival was defined as the time from randomization until the first documented day of disease progression or relapse, using a modified version of the Revised Response Criteria for Malignant Lymphoma, or death from any cause, whichever occurred first, on the basis of investigator assessments. Progression was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. Tumor measurements were obtained by computed tomography (CT) or magnetic resonance imaging (MRI).|Baseline up to data cut-off (up to approximately 4 years and 9 months)|The intent-to-treat (ITT) population included all randomized participants.||percentage of participants|||Number
835460|NCT01287754|Secondary|Percentage of Participants With EGFR Mutation at Screening|Participants were tested at Screening for the presence of activating mutations in the tyrosine kinase domain of EGFR. The percentage of participants with mutation was calculated as [number of mutation-positive participants divided by number tested] multiplied by 100.|Screening|All Participants Enrolled||percentage of participants||95% Confidence Interval|Number
835461|NCT01287754|Secondary|Percentage of Participants Alive at 6 and 12 Months|Death from any cause was documented at 6 and 12 months from recorded diagnosis. The percentage of participants alive at each timepoint was calculated as [number of participants alive divided by number enrolled] multiplied by 100.|At 6 and 12 months|All Participants Enrolled||percentage of participants|||Number
835462|NCT01287754|Secondary|Overall Survival (OS) Among Erlotinib-Treated and Untreated Participants|OS was defined as the time from recorded diagnosis to death from any cause or last patient last visit. OS was calculated in months as [death date or last-known alive date minus diagnosis date plus 1] divided by 30.44.|Per standard of care (every 3 months) until discontinuation for up to approximately 2 years|All Participants Enrolled: All erlotinib-treated participants who received at least one dose of erlotinib, in addition to all enrolled untreated participants, were included in the analysis.||months||95% Confidence Interval|Median
835463|NCT01287754|Secondary|Number of Erlotinib-Treated Participants With the EGFR Mutation With an Objective Response Per RECIST v1.1|Objective tumor response was assessed by the investigator using RECIST v1.1 and recorded as complete response (CR), partial response (PR), or unmeasurable. RECIST v1.1 defines CR as disappearance of all target lesions, with short-axis reduction to less than (<) 10 mm for any pathological lymph nodes, and PR as a 30% or greater reduction from baseline in the sum of diameters of target lesions.|Per standard of care (every 3 months) until discontinuation for up to approximately 2 years|All Participants Treated||participants|||Number
835464|NCT01287754|Primary|Progression-Free Survival (PFS) Among Erlotinib-Treated Participants With the EGFR Mutation|PFS was defined as the time from the first dose of erlotinib to the first documentation of disease progression or death, whichever occurred first. Tumor progression was determined using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), which defines progression as a 20 percent (%) or greater increase in the sum of diameters of target lesions with an absolute increase of at least 5 millimeters (mm), or the appearance of one or more new lesions. PFS was calculated in months as [first event date minus first dose date plus 1] divided by 30.44.|Per standard of care (every 3 months) until discontinuation for up to approximately 2 years|All Participants Treated: All participants who received at least one dose of erlotinib were included in the analysis.||months||95% Confidence Interval|Median
835465|NCT01287832|Secondary|Adverse Event Rate in Each Arm, Including the Nephrotoxicity and Skeletal Muscle Toxicity||30-42 days post-treatment||||||
835466|NCT01287832|Primary|Number of Participants With Clinical Success at Test of Cure Visit.|Clinical success is the absence of treatment failures. Treatment failures will include death, clinical failure, microbiologic failure, or an adverse event requiring a change in therapy or discontinuation in therapy.|30-42 days post-treatment|||participants|||Number
835467|NCT01287897|Secondary|Number of Participants Who Withdrew From the Study Due to Treatment-emergent Adverse Events (AEs)|An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. Treatment-emergent were events between first dose of treatment and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Induction period: from Week 0 (Day 1) through Week 12; follow-up period: from Week 12 (or discontinuation from the induction period) through last subject visit (up to 28 weeks after completion of or discontinuation from the 12-week induction period)|"The SAS consisted of all participants who received at least 1 dose of study drug. n signifies number of participants with observed data at the time point of each arm. From Weeks 16 to 40, only participants who remained in the follow-up period of this study and did not enter NCT01405196 were analyzed."||participants|||Number
835468|NCT01287897|Secondary|Serum PF-04236921 Concentration Over Time||Day 1 (predose), and at Weeks 2, 4 (Day 28, predose), 8, 10, 12, 16, 20, 24, 28, 32, 36, and 40|"The pharmacokinetic (PK) analysis set was the subset of participants from the SAS who provided at least 1 PK concentration (2 participants [10 mg arm] excluded due to a quality issue). n is the number of participants with PK data at the visit. From Weeks 16 to 40, only participants who remained in the follow-up period of this study were analyzed."||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
835530|NCT01288612|Secondary|Rate of Acquisition of Biopsies From the Esophagus||Visit 1|The analysis population included all subjects who agreed to undergo the esophageal assessment (intent to treat).||percentage of participants|||Number
835469|NCT01287897|Secondary|Percentages of Participants With Confirmed Positive Neutralizing Antibodies (NAbs)|The percentage of participants with confirmed positive NAbs was summarized for each treatment arm. Only ADA positive samples were analyzed for Nab. A multi-tiered approach was utilized to detect NAbs. NAb serum samples were screened at tier one, and those found presumptively NAb positive was further tested with the confirmatory assay (tier two). The percentage of subjects with confirmed positive NAbs was summarized for each treatment.|At baseline (Day 1) and at Weeks 4, 8, 12, 16, 24, 32 and 40|"The SAS consisted of all participants who received at least 1 dose of study drug. n signifies number of participants with observed data at the time point of each arm. From Weeks 16 to 40, only participants who remained in the follow-up period of this study and did not enter NCT01405196 were analyzed."||percentage of participants|||Number
835470|NCT01287897|Secondary|Percentages of Participants With Confirmed Positive Anti-drug Antibodies (ADAs)|The percentage of participants with confirmed positive ADA was summarized for each treatment arm. ADA positive was defined as ADA titer defined as ADA titer (ie, the reciprocal of the highest dilution that gives a value equivalent to the cut point of the assay) >= 4.32.|At baseline (Day 1) and at Weeks 4, 8, 12, 16, 24, 32 and 40|"The SAS consisted of all participants who received at least 1 dose of study drug. n signifies number of participants with observed data at the time point of each arm. From Weeks 16 to 40, only participants who remained in the follow-up period of this study and did not enter NCT01405196 were analyzed."||percentage of participants|||Number
835471|NCT01287897|Secondary|Change From Baseline in CDAI Score Over Time in Participants Who Received Placebo and PF-04236921 200 mg|CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit, and higher score indicate more severe disease. The Outcome included a Linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). Since the inputs in the model included different Analysis Population than in Outcome Measure 11, that will yield different estimates for placebo for the two different models.|Baseline and Weeks 2, 4, 6, 8, 10, and 12|"The analysis was performed on the FAS 200 mg vs placebo. The 200 mg arm was halted before reaching the planned sample size of approximately 60 participants. n signifies the number of subjects with observed data of each arm at each time point."||points on a scale||90% Confidence Interval|Least Squares Mean
835472|NCT01287897|Secondary|Change From Baseline in CDAI Score Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg|CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit, and higher score indicate more severe disease. The Outcome included a Linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference).|Baseline and Weeks 2, 4, 6, 8, 10, and 12|"The analysis was performed on the FAS excluding 200 mg arm (which was halted prematurely). n signifies the number of subjects with observed data of each arm at each time point."||points on a scale||90% Confidence Interval|Least Squares Mean
835473|NCT01287897|Secondary|The CDAI-100 Response Rate Over Time in Participants Who Received Placebo and PF-04236921 200 mg|CDAI-100 response was defined as a decrease in CDAI score of 100 or greater from baseline. The proportions of participants with CDAI-100 response at Week 12 were compared between placebo and PF-04236921 200 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). Since the inputs in the model included different Analysis Population than in Outcome Measure 9, that will yield different estimates for placebo for the two different models.|Baseline and Weeks 2, 4, 6, 8, 10, and 12|"The analysis was performed on the FAS 200 mg vs placebo. The 200 mg arm was halted before reaching the planned sample size of approximately 60 participants. n signifies the number of subjects with observed data of each arm at each time point."||Percentage of participants||90% Confidence Interval|Least Squares Mean
835474|NCT01287897|Secondary|The CDAI-100 Response Rate Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg|CDAI-100 response was defined as a decrease in CDAI score of 100 or greater from baseline. The proportions of participants with CDAI-100 response at Week 12 were compared between placebo and PF-04236921 10 mg/50 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference).|Baseline and Weeks 2, 4, 6, 8, 10, and 12|"The analysis was performed on the FAS excluding 200 mg arm (which was halted prematurely). n signifies the number of subjects with observed data of each arm at each time point."||Percentage of participants||90% Confidence Interval|Least Squares Mean
835475|NCT01287897|Secondary|The CDAI Remission Rate Over Time in Participants Who Received Placebo and PF-04236921 200 mg|CDAI remission rate was defined as an absolute CDAI score <150. The proportions of participants with CDAI remission were compared between placebo and PF-04236921 200 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). Since the inputs in the model included different Analysis Population than in Outcome Measure 7, that will yield different estimates for placebo for the two different models.|Baseline and Weeks 2, 4, 6, 8, 10, and 12|"The analysis was performed on the FAS 200 mg vs placebo. The 200 mg arm was halted before reaching the planned sample size of approximately 60 participants. n signifies the number of subjects with observed data of each arm at each time point."||Percentage of participants||90% Confidence Interval|Least Squares Mean
835476|NCT01287897|Secondary|The CDAI Remission Rate Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg|CDAI remission rate was defined as an absolute CDAI score less than (<) 150. The proportions of participants with CDAI remission were compared between placebo and PF-04236921 10 mg/50 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference).|Baseline and Weeks 2, 4, 6, 8, 10, and 12|"The analysis was performed on the FAS excluding 200 mg arm (which was halted prematurely). n signifies the number of subjects with observed data of each arm at each time point."||Percentage of participants||90% Confidence Interval|Least Squares Mean
835477|NCT01287897|Secondary|The CDAI-70 Response Rate Over Time in Participants Who Received Placebo and PF-04236921 200 mg|CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response were compared between placebo and PF-04236921 200 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). Since the inputs in the model included different Analysis Population than in Outcome Measure 5, that will yield different estimates for placebo for the two different models.|Baseline and Weeks 2, 4, 6, and 10|"The analysis was performed on the FAS 200 mg vs placebo. The 200 mg arm was halted before reaching the planned sample size of approximately 60 participants. n signifies the number of subjects with observed data of each arm at each time point."||Percentage of participants||90% Confidence Interval|Least Squares Mean
835478|NCT01287897|Secondary|The CDAI-70 Response Rate Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg|CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response were compared between placebo and PF-04236921 10 mg/50 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference).|Baseline and Weeks 2, 4, 6, and 10|"The analysis was performed on the FAS excluding 200 mg arm (which was halted prematurely). n signifies the number of subjects with observed data of each arm at each time point."||Percentage of participants||90% Confidence Interval|Least Squares Mean
835479|NCT01287897|Primary|The CDAI-70 Response Rate at Week 12 in Participants Who Received Placebo and PF-04236921 200 mg|CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response at Week 12 were compared between placebo and PF-04236921 200 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). Since the inputs in the model included different Analysis Population than in Outcome Measure 3, that will yield different estimates for placebo for the two different models.|Baseline and Week 12|The analysis was performed on FAS 200 mg vs placebo. The 200 mg arm was halted before reaching the planned sample size of approximately 60 and was no longer powered at the planned level to test against placebo. Thus, the 200 mg vs placebo comparison is a sensitivity analysis.||Percentage of participants||90% Confidence Interval|Least Squares Mean
835480|NCT01287897|Primary|The CDAI-70 Response Rate at Week 12 in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg|CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response at Week 12 were compared between placebo and and PF-04236921 10 mg/50 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference).|Baseline and Week 12|Primary analysis: FAS excluding 200 mg arm (halted prematurely before reaching the planned sample size and thus no longer powered at the planned level to test against placebo).||Percentage of participants||90% Confidence Interval|Least Squares Mean
835491|NCT01288209|Secondary|Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24h) for TMC435|"The table below shows the median (range) AUC24h values for participants in each treatment group at Week 12, Week 24, and Overall (Weeks 4, 12, and 24). The time frame of “Overall” represents the median exposure estimate using all available data collected at Weeks 4, 12, and 24 for each participant in the study. The number of participants analyzed is listed at each time point in order of the treatment groups from left to right in the table (ie, Week x, n=x, x) if different from the “Number of Participants Analyzed."|Week 12, Week 24, and Overall (Weeks 4, 12, and 24)|Pharmacokinetic analysis was performed in the pharmacokinetic (PK) population, defined as all participants from whom sparse blood samples were drawn and who received at least 1 dose of study medication.||ng.h/mL||Full Range|Median
835644|NCT01289574|Secondary|Success on Investigator Global Assessment (IGA) at Week 12|"Overall acne rated as clear, almost clear, mild, moderate, severe, very severe.
Success = Week 12 rating of clear or almost clear and at least a 2-grade improvement from baseline"|12 weeks|All randomized subjects||Percentage of subjects|||Number
835481|NCT01287897|Primary|The CDAI-70 Response Rate at Week 8 in Participants Who Received Placebo and PF-04236921 200 mg|CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response at Week 8 were compared between placebo and PF-04236921 200 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). Since the inputs in the model included different Analysis Population than in Outcome Measure 1, that will yield different estimates for placebo for the two different models.|Baseline and Week 8|The analysis was performed on FAS participants of the 200 mg and placebo arms, referred to as FAS 200 mg versus (vs) placebo. The 200 mg arm was halted before reaching the planned sample size of approximately 60 and was no longer powered at the planned level to test against placebo. Thus, the 200 mg vs placebo comparison is a sensitivity analysis.||Percentage of participants||90% Confidence Interval|Least Squares Mean
835482|NCT01287897|Primary|The Crohn’s Disease Activity Index (CDAI)-70 Response Rate at Week 8 in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg|CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response at Week 8 were compared between placebo and PF-04236921 10 mg/50 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score greater than or equal to (>=) 0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference).|Baseline and Week 8|Primary analysis: full analysis set (FAS, defined as all randomized participants who received at least 1 dose of study treatment; 2 participants [10 mg arm] excluded due to a quality issue) excluding 200 mg (halted prematurely before reaching the planned sample size and thus no longer powered at the planned level to test against placebo).||Percentage of participants||90% Confidence Interval|Least Squares Mean
835483|NCT01288027|Secondary|Percent Change From Baseline in Disease Activity Using T2 Magnetic Resonance Imaging (MRI) at Week 26|Disease activity (inflammation and/or water content within muscles) was quantitatively assessed by T2 MRI values in a subset of participants. A T2 MRI value of greater than (>) 39 millisecond (ms) was defined as abnormal. T2 estimation normally requires an additional acquisition for computing the B1 spatial deviation however, can still be estimated if this acquisition is missing.|Baseline, Week 26|FAS population included all participants who received at least one complete infusion of alglucosidase alfa. Here Number of participants analyzed = number of participants with both baseline and Week 26 assessment of disease activity.||percent change||Standard Deviation|Mean
835484|NCT01288027|Secondary|Percent Change From Baseline in Degree of Fatty Infiltration Using 3-Point 3-Dimensional (3D) Dixon at Week 26|Degree of Fatty Infiltration was assessed by 3-point 3D Dixon acquisition using skeletal muscle MRI in a subset of participants.|Baseline, Week 26|FAS population included all participants who received at least one complete infusion of alglucosidase alfa. Here, number of participants analyzed = number of participants with both Baseline and Week 26 assessment of degree of fatty infiltration.||percent change||Standard Deviation|Mean
835485|NCT01288027|Secondary|Percent Change From Baseline in Muscle Involvement Using Mercuri Scoring at Week 26|Muscle involvement was assessed by T1-weighted magnetic resonance imaging (MRI). T1-weighted MRI data was analyzed using the Mercuri scoring in both legs (Total score = 1-4; where 1=Normal appearance, 2=Mild involvement, 3=Moderate involvement, and 4=Severe involvement). For each participants, the average for each the upper (thigh) and lower leg was computed for Mercuri grading.|Baseline, Week 26|FAS population included all participants who received at least one complete infusion of alglucosidase alfa. Here, Number of participants analyzed= participants with both Baseline and Week 26 assessment of muscle involvement, n= number of participants with both Baseline and Week 26 assessment of muscle involvement for specified category.||percent change||Standard Deviation|Mean
835486|NCT01288027|Secondary|Lysosomal Inclusions||Baseline, Week 26|No quantitative data could be reported for this outcome as the assessment was qualitative in nature.|||||
835487|NCT01288027|Secondary|Muscle Fiber Morphology||Baseline, Week 26|No quantitative data could be reported for this outcome as the assessment was qualitative in nature.|||||
835488|NCT01288027|Secondary|Glycogen Distribution||Baseline, Week 26|No quantitative data could be reported for this outcome as the assessment was qualitative in nature.|||||
835489|NCT01288027|Primary|Change From Baseline in Tissue Glycogen Content in Quadriceps Muscle Biopsy Samples at Week 26|Tissue glycogen content was measured by quadriceps biopsies as ‘percent area of tissue occupied by glycogen'.|Baseline, Week 26|FAS population included all participants who received at least one complete infusion of alglucosidase alfa. Here, n = number of participants with both Baseline and Week 26 assessment of tissue glycogen content.||percent area occupied by glycogen||Standard Deviation|Mean
835490|NCT01288079|Primary|Change in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score From Randomization to End of Treatment|A 10-item scale for the evaluation of depressive symptoms. Each Montgomery Asberg Depression Rating Scale (MADRS) item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214, duloxetine or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
835508|NCT01288443|Secondary|Percent Change From Baseline in Fasting Triglycerides and Lipoprotein(a) at Week 12 - On-Treatment Analysis|Since the assumptions of normal distribution and equality of variances were not verified for the lipid parameters, percent changes were expressed as median (inter-quartile range).|Baseline to Week 12 (LOCF)|Participants of the mITT population with one baseline and at least one post-baseline on-treatment value for lipid parameters analyzed. Here, n signifies number of participants analysed for each lipid parameter.||percent change||Inter-Quartile Range|Median
835492|NCT01288209|Secondary|Plasma Concentrations of TMC435|"The table below shows median (range) TMC435 predose plasma concentration (C0h) values and TMC435 maximum plasma concentration (Cmax) values for participants in each treatment group at Week 12, Week 24, and Overall (Weeks 4, 12, and 24). The time frame of “Overall” representes the median exposure estimate using all available data collected at Weeks 4, 12, and 24 for each participant in the study. The number of participants analyzed is listed at each time point in order of the treatment groups from left to right in the table (ie, Week x, n=x, x) if different from the “Number of Participants Analyzed."|Week 12, Week 24, and Overall (Weeks 4, 12, and 24)|Pharmacokinetic analysis was performed in the pharmacokinetic (PK) population, defined as all participants from whom sparse blood samples were drawn and who received at least 1 dose of study medication.||ng/mL||Full Range|Median
835493|NCT01288209|Secondary|The Percentage of Participants Who Met Response Guided Treatment (RGT) Criteria and Completed Treatment With Peginterferon Alpha-2a (PegIFNα-2a) and Ribavirin (RBV) at Week 24|The table below shows the percentage of participants in each treatment group who met RGT criteria (ie, who had plasma levels of hepatitis C virus ribonucleic acid [HCV RNA] <1.2 log10 IU/mL detectable/undetectable at Week 4 and <1.2 log 10 IU/mL undetectable at Week 12) and completed treatment with PegIFNα-2a and RBV at Week 24. Participants in the TMC435 treatment groups not meeting RGT criteria continued treatment with PegIFNα-2a and RBV to Week 48.|Week 24|The Full Analysis Set (FAS) consisted of all randomized participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.||Percentage of participants|||Number
835494|NCT01288209|Secondary|The Number Participants With Abnormal Alanine Aminotransferase (ALT) Levels at Baseline Who Achieved Normal ALT Levels at the End of Treatment (EOT)|The table below shows the number of participants in each treatment group with abnormal ALT levels at baseline (Day 1) who achieved normalization of ALT levels defined as having an ALT value less than or equal to the Upper Limit of Normality (ie, 40 IU/mL) at the EOT. At Baseline, 34/53 participants in the TMC435 100 mg 12 Wks PR 24/48 treatment group and 35/53 participants in the TMC435 100 mg 24 Wks PR 24/48 treatment group had abnormal ALT levels.|EOT (Week 24 or 48)|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.||Participants|||Number
835495|NCT01288209|Secondary|The Number of Participants Demonstrating Viral Relapse During the Study|The table below shows the number of participants in each treatment group who demonstrated viral relapse during the study. Viral relapse is defined as undetectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels at EOT and detectable HCV RNA during follow-up or detectable HCV RNA at the time points for a sustained viral response (SVR) assessment. The incidence of viral relapse was only calculated for participants with undetectable HCV RNA levels at EOT and with at least one follow-up HCV RNA measurement.|Up to 72 weeks|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.||Participants|||Number
835496|NCT01288209|Secondary|The Number of Participants With Viral Breakthrough During the Study|The table below shows the number of all participants in each treatment group who experienced viral breakthrough during the treatment period in the study (Baseline to end of treatment [EOT], ie, Week 24 or 48). Viral breakthrough is defined as a confirmed increase of greater than (>) 1 log10 IU/mL in plasma hepatitis C virus (HCV) ribonucleic acid (RNA) level from the lowest level reached or a confirmed value of plasma HCV RNA of > 2.0 log10 IU/mL in all participants whose plasma HCV RNA level had previously been below 1.2 log10 IU/mL detectable or undetectable.|Up to EOT (Week 24 or 48)|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.||Participants|||Number
835497|NCT01288209|Secondary|The Percentage of Participants With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels During Treatment for Participants Who Did Not Achieve Undetectable Plasma HCV RNA Levels at Week 12|"The table below shows the percentage of participants with undetectable HCV RNA at Weeks 24, 48, end of treatment (EOT), at the time of assessment for a sustained virologic response (SVR) 12 weeks after the last planned dose (SVR12) (Week 36 or 60), and SVR24 (Week 48 or 72) who did not achieve undetectable HCV RNA levels at Week 12. The number of participants analyzed is listed at each time point in order of the treatment groups from left to right in the table (ie, Week x, n=x, x) if different from the “Number of Participants Analyzed. Results are not available for Weeks 24, 48, and EOT because there were no participants who met the criteria for a SVR at those time points."|Weeks 24, 48, EOT (Weeks 24 or 48), SVR12 (Weeks 36 or 60), and SVR24 (Weeks 48 or 72)|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.||Percentage of participants|||Number
835498|NCT01288209|Secondary|The Percentage of Participants With Undetectable Plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) During Treatment and at the End of Treatment (EOT)|The table below shows the percentage of participants with undetectable HCV RNA (<1.2 log10 IU/mL) during treatment at Weeks 4, 12, 24, 36, 48, 60, 72, and at EOT (Week 24 or 48).|Weeks 4, 12, 24, 36, 48, 60, 72, and at EOT|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.||Percentage of participants|||Number
835509|NCT01288443|Secondary|Percent Change From Baseline in Total Cholesterol, High-density Lipoprotein Cholesterol (HDL-C), Non-HDL-C and Apolipoprotein B (Apo-B) at Week 12 - On-Treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|Baseline to Week 12 (LOCF)|Participants of the mITT population with one baseline and at least one post-baseline on-treatment value for lipid parameters analyzed. Here, n signifies the number of participants analysed for each lipid parameter.||percent change||Standard Error|Least Squares Mean
835645|NCT01289574|Primary|Percent Change in Inflammatory Acne Lesion Counts|Percent change from Baseline|12 weeks|All randomized patients||Percentage change from baseline||Standard Deviation|Mean
835499|NCT01288209|Secondary|The Percentage of Participants Who Achieved a Greater Than or Equal to 2 log10 IU/mL Drop From Baseline in Plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) at Each Time Point During Treatment and Follow-up|The table below shows the percentage of participants in each treatment group with a greater than (>) or equal to (=) 2 log10 IU/mL drop from baseline in HCV RNA at each time point during treatment and post-treatment follow-up.|Day 3, Day 7, and Weeks 2, 3, 4, 8, 12, 16, 20, 24, 28, 36, 48, 60, 72, EOT, and Follow-up (FU) Weeks 4, 12, and 24|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.||Percentage of participants|||Number
835500|NCT01288209|Secondary|The Percentage of Participants With a Sustained Virologic Response 24 Weeks After the End of Treatment (EOT) and 24 Weeks After the Last Dose of Treatment (SVR24)|The table below shows the observed percentage of participants in each treatment group with a SVR24 defined as undetectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels at the EOT (Week 24 or 48) and at 24 weeks after the last dose of treatment (Week 48 or 72).|EOT (Week 24 or 48) and Week 48 or 72|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.||Percentage of participants|||Number
835501|NCT01288209|Primary|The Percentage of Participants With a Sustained Virologic Response at the End of Treatment (EOT) and 12 Weeks After the Last Dose of Treatment (SVR12)|The table below shows the observed percentage of participants in each treatment group with a SVR12 defined as undetectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels at the EOT (Week 24 or 48) and at 12 weeks after the last dose of treatment (Week 36 or 60).|EOT (Week 24 or 48) and Week 36 or 60|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.||Percentage of participants|||Number
835502|NCT01288287|Secondary|Change From Baseline in Health Assessment Questionnaire-Disease Index (HAQ-DI) Scores at 78 Weeks|HAQ-DI is a questionnaire which measures function and health-related quality of life. The final score range is 0-3, with higher scores denoting greater disability. A negative value in HAQ-DI change from Baseline indicates an improvement from Baseline to 78 weeks.|Baseline (Week 0), 78 weeks|Full Analysis Set (FAS) consists of all patients entered into the study who take at least one dose of Certolizumab Pegol and have a valid, non-missing complete DAS28(ESR) score at Baseline and Week 12 (+/- 2 weeks).||units on a scale||Standard Deviation|Mean
835503|NCT01288287|Secondary|Change From Baseline in Rheumatoid Arthritis Disease Activity Index (RADAI) Scores at 78 Weeks|"RADAI is a five-item questionnaire administered to patients. The final score range is 0-10, with higher scores denoting a worse disease state.
A negative value in RADAI change from Baseline indicates an improvement from Baseline to 78 weeks."|Baseline (Week 0), 78 weeks|Full Analysis Set (FAS) consists of all patients entered into the study who take at least one dose of Certolizumab Pegol and have a valid, non-missing complete DAS28(ESR) score at Baseline and Week 12 (+/- 2 weeks).||units on a scale||Standard Deviation|Mean
835504|NCT01288287|Secondary|Percentage of Participants With a Disease Activity Score (DAS)-Based European League Against Rheumatoid Arthritis (EULAR) Response at 78 Weeks Compared to Baseline|"Percentage of patients achieving good, moderate, or no EULAR clinical response, where good response is defined as DAS28(ESR) ≤ 3.2 and decrease from baseline by > 1.2; moderate response is defined as achievement of one of the following:
DAS28(ESR) ≤ 3.2 and decrease from baseline > 0.6 and ≤ 1.2,
DAS28(ESR) > 3.2 and ≤ 5.1 and decrease from baseline > 0.6,
DAS28(ESR) > 5.1 and decrease from baseline > 1.2 Patients without a good or moderate response are considered to be non-responders."|Baseline (Week 0), 78 weeks|Full Analysis Set (FAS) consists of all patients entered into the study who take at least one dose of Certolizumab Pegol and have a valid, non-missing complete DAS28(ESR) score at Baseline and Week 12 (+/- 2 weeks).||percentage of patients|||Number
835505|NCT01288287|Secondary|Change From Baseline in Disease Activity Score 28-joint Count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] Score at 78 Weeks|"DAS28(ESR) is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC), ESR (mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm). 28 joints are examined using:
DAS28(ESR) = 0.56 * √(TJC) + 0.28* √(SJC) + 0.70* ln(ESR) + 0.014* PtGADA, with TJC=0 to 28, SJC=0 to 28, PtGADA=0 to 100 mm, ESR=0 to infinite mm/hour but ESR values of greater 250 mm/h are typically measurement errors.
DAS28(ESR) ranges from 0 to around 10 with lower scores indicating less disease activity."|Baseline (Week 0), 78 weeks|Full Analysis Set (FAS) consists of all patients entered into the study who take at least one dose of Certolizumab Pegol and have a valid, non-missing complete DAS28(ESR) score at Baseline and Week 12 (+/- 2 weeks).||units on a scale||Standard Deviation|Mean
835506|NCT01288287|Primary|Percentage of Participants With a Disease Activity Score (DAS) Response at 78 Weeks Where DAS Response is Defined as a Reduction From Baseline in DAS 28-joint Count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] Score of Greater Than 1.2 Points|"DAS28(ESR) is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC), ESR (mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm). 28 joints are examined using:
DAS28(ESR) = 0.56 * √(TJC) + 0.28* √(SJC) + 0.70* ln(ESR) + 0.014* PtGADA, with TJC=0 to 28, SJC=0 to 28, PtGADA=0 to 100 mm, ESR=0 to infinite mm/hour but ESR values of greater 250 mm/h are typically measurement errors.
DAS28(ESR) ranges from 0 to around 10 with lower scores indicating less disease activity."|Baseline (Week 0), 78 weeks|Full Analysis Set (FAS) consists of all patients entered into the study who take at least one dose of Certolizumab Pegol and have a valid, non-missing complete DAS28(ESR) score at Baseline and Week 12 (+/- 2 weeks).||percentage of patients||95% Confidence Interval|Number
835507|NCT01288443|Secondary|Absolute Change in the Ratio Apolipoprotein B/Apolipoprotein A-1 (ApoB/ApoA-1) From Baseline to Week 12 - On-Treatment Analysis|Adjusted LS mean and standard errors were estimated using the same ANCOVA as for primary endpoint.|Baseline to Week 12 (LOCF)|Participants of the mITT population with one baseline and at least one post-baseline on-treatment value for ApoB/ApoA-1 ratio analyzed.||ratio||Standard Error|Least Squares Mean
835510|NCT01288443|Secondary|Percentage of Participants Achieving Calculated LDL-C <100 mg/dL (2.59 mmol/L) and <70 mg/dL (1.81 mmol/L) at Week 12 - On-Treatment Analysis||Week 12 (LOCF)|mITT population.||percentage of participants|||Number
835513|NCT01288443|Primary|Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis|Calculated LDL-C values were obtained using the Friedewald formula. Baseline adjusted least squares (LS) means and standard errors were estimated using an analysis of covariance (ANCOVA) model including available post-baseline data on treatment from first study drug injection up to 21 days after last study drug injection (on-treatment analysis). Missing Week 12 data were imputed by last observation carried forward [LOCF] method.|Baseline to Week 12 (LOCF)|Modified Intent-To-Treat (mITT) population included all randomized participants with one baseline and at least one post baseline on-treatment calculated LDL-C.||percent change||Standard Error|Least Squares Mean
835514|NCT01288469|Secondary|Absolute Change in the Ratio Apolipoprotein B/Apolipoprotein A-1 (ApoB/ApoA-1) From Baseline to Week 8 - On-treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA as for primary endpoint.|From Baseline to Week 8 (LOCF)|Participants of the mITT population with one baseline and at least one post-baseline on treatment value for lipid parameter analyzed||ratio||Inter-Quartile Range|Median
835515|NCT01288469|Secondary|Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Week 8 - On-treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|From Baseline to Week 8 (LOCF)|Participants of the mITT population with one baseline and at least one post-baseline on treatment HDL-C value.||percent change||Standard Error|Least Squares Mean
835516|NCT01288469|Secondary|Percent Change From Baseline in Total Cholesterol, Fasting Triglycerides, Non-high-Density Lipoprotein Cholesterol (Non-HDL-C), Apolipoprotein B (Apo-B) and Lipoprotein(a) at Week 8 - On-treatment Analysis|Since the assumptions of normal distribution and equality of variances were not verified for the lipid parameters, percent changes were expressed as median (interquartile range).|From baseline to Week 8 (LOCF)|Participants of the mITT population with one baseline and at least one post-baseline on treatment value for lipid parameters analyzed. Here, n signifies number of participants analysed for each lipid parameter.||percent change||Inter-Quartile Range|Median
835517|NCT01288469|Secondary|Percentage of Participants Achieving Calculated LDL-C <100 mg/dL (2.59 mmol/L) and < 70 mg/dL (1.81 mmol/L) at Week 8 - On-treatment Analysis||Week 8 (LOCF)|mITT population.||percentage of participants|||Number
835518|NCT01288469|Secondary|Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Week 8 - On-treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|From baseline to Week 8 (LOCF)|mITT population.||mg/dL||Standard Error|Least Squares Mean
835519|NCT01288469|Secondary|Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Week 8 - On-treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|From baseline to Week 8 (LOCF)|mITT population.||mmol/L||Standard Error|Least Squares Mean
835520|NCT01288469|Primary|Percent Change From Baseline in Calculated LDL-C at Week 8 - On-treatment Analysis|Calculated LDL-C values were obtained using the Friedewald formula. Baseline adjusted least squares (LS) means and standard errors were estimated using an analysis of covariance (ANCOVA) model including available post-baseline data on treatment from first investigational product (IP) injection up to 21 days after last IP injection (on-treatment analysis). Missing Week 8 data were imputed by last observation carried forward [LOCF] method.|From Baseline to Week 8 (LOCF)|Modified Intent-To-Treat (mITT) population: all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.||percent change||Standard Error|Least Squares Mean
835526|NCT01288612|Secondary|Acceptability|Acceptability was defined as the proportion of subjects willing to undergo the procedure again in the future.|Day 1 after the procedure|The analysis population included all subjects who agreed to undergo the esophageal assessment (intent to treat).||percentage of participants|||Number
835527|NCT01288612|Secondary|Mean Tolerability Scores|Validated pain scales (where 0 is none and 10 is severe) were used to assess the degree of pain, choking, gagging, and anxiety experienced during the procedure. Overall tolerance was rated on a scale from 0 to 10, where 0 is good, and 10 is poor tolerance.|Day 1 after the procedure|The analysis population included all subjects who agreed to undergo the esophageal assessment (intent to treat).||units on a scale||Standard Deviation|Mean
835528|NCT01288612|Secondary|Mean Time From Extubation to Discharge|This outcome measures the recovery time after the procedure.|Visit 1|The analysis population included all subjects who agreed to undergo the esophageal assessment (intent to treat).||minutes||Standard Deviation|Mean
835529|NCT01288612|Secondary|Mean Duration of Procedure|Duration of the procedure was defined as time from the beginning of the procedure (initiation of sedation or local anesthesia) to extubation.|Visit 1|The analysis population included all subjects who agreed to undergo the esophageal assessment (intent to treat).||minutes||Standard Deviation|Mean
835646|NCT01290224|Secondary|Analgesic Use Over Time||On days 1-11 and for 10 weeks after therapy|||participants|||Number
835531|NCT01288612|Secondary|Rate of Complete Evaluation|The rate of complete evaluation was defined as visualization of the whole esophagus and identification of landmarks: squamocolumnar junction, gastroesophageal junction (upper margin of gastric folds with stomach deflated), and the diaphragmatic hiatus. The categories of evaluation were classified as complete (all three landmarks identified), incomplete (some landmarks identified), or unsuccessful.|Visit 1|The analysis population included all subjects who agreed to undergo the esophageal assessment (intent to treat).||procedures|||Number
835532|NCT01288612|Secondary|Rate of Successful Intubation|The rate of successful intubation was defined as the ability to traverse the upper esophageal sphincter and visualize the esophageal mucosa and classified as successful or unsuccessful.|Visit 1|The analysis population included all subjects who agreed to undergo the esophageal assessment (intent to treat).||percentage of participants|||Number
835533|NCT01288612|Primary|Percentage of Subjects Who Agreed to Participated in the Esophageal Assessment|This outcome measure was defined as the proportion of subjects who agreed to undergo esophageal assessment in the three groups out of those who were eligible to be contacted for participation in screening.|Approximately 2 weeks after invitation letter was sent|The analysis population for this outcome measure was the number of subjects per group who were eligible to contact.||percentage of participants|||Number
835534|NCT01288729|Primary|Length of Wear of Infusion Site|Comparison of the length of wear (hours) of Sure-T Steel Infusion Set Catheter versus Quick-Set Teflon Catheter. Infusion sets are currently approved for wear 2-3 days (24-72 hours). Participants wore each set for up to 7 days twice. Outcome measure is presented according to the intervention (Steel or Teflon catheter).|5 weeks|Participants with available data were analyzed.||hours||Inter-Quartile Range|Median
835535|NCT01288781|Secondary|Change in Optic Nerve Sheath Diameter|Baseline is defined as the average of the 3 hour and 12 hour normoxia measurements. 36 hours is defined at the 36 hour hypoxia measurement.|Optic Nerve Sheath Diameter: baseline, 36 hours.|All participants were included. Analysis was intention to treat. There were no missing data.||mm||Standard Deviation|Mean
835536|NCT01288781|Secondary|Change in Optic Nerve Sheath Diameter|Baseline is defined as the average of the 3 hour 12 hour normoxia measurements. 12 hours is defined at the 12 hour hypoxia measurement.|Optic Nerve Sheath Diameter: baseline, 12 hours.|All participants were included. Analysis was intention to treat. There were no missing data.||mm||Standard Deviation|Mean
835537|NCT01288781|Secondary|Change in Optic Nerve Sheath Diameter|Baseline is defined as the average of the 3 hour 12 hour normoxia measurements. 3 hours is defined at the 3 hour hypoxia measurement.|Optic Nerve Sheath Diameter: baseline, 3 hours.|All participants were included. Analysis was intention to treat. There were no missing data.||mm||Standard Deviation|Mean
835538|NCT01288781|Secondary|Change in Fluid Balance|"Baseline is defined as the average of the 3 hour and 12 hour normoxia measurement. 24 hours is defined at the 24 hour hypoxia measurement. Urine output was recorded by 24 hour urine collection and fluid intake by 24 hour food diaries. Fluid balance was calculated as:
(urine output (L) / fluid intake (L) ) * 100."|Fluid Balance: baseline, 24 hours.|All participants were included. Analysis was intention to treat. There were no missing data.||% of fluid intake||Standard Deviation|Mean
835539|NCT01288781|Secondary|Change in Blood Oxygen Saturation|Baseline is defined as the average of the 3 hour and 12 hour normoxia measurement. 24 hours is defined at the 24 hour hypoxia measurement.|Blood Oxygen Saturation: baseline, 24 hours.|All participants were included. Analysis was intention to treat. There were no missing data.||% oxygen saturation||Standard Deviation|Mean
835540|NCT01288781|Secondary|Change in High Altitude Headache by Visual Analogue Scale|Baseline is defined as the average of the 3 hour and 12 hour normoxia measurement. 24 hours is defined at the 24 hour hypoxia measurement. Outcome measured using visual analogue scale, where 0 mm is no headache and 100 mm is maximum headache.|High Altitude Headache: baseline, 24 hours.|All participants were included. Analysis was intention to treat. There were no missing data.||mm||Standard Deviation|Mean
835541|NCT01288781|Primary|Change in Optic Nerve Sheath Diameter by Ultrasonography|"Baseline is defined as the average of the 3 hour and 12 hour normoxia measurement.
24 hours is defined at the 24 hour hypoxia measurement. Optic nerve sheath diameter obtained by ultrasonography of the eye. Increased optic nerve sheath diameter suggests greater intra cranial pressure."|Optic Nerve Sheath Diameter: baseline, 24 hours.|All participants were included. Analysis was intention to treat. There were no missing data.||mm||Standard Deviation|Mean
835542|NCT01288859|Primary|Amount of Total Fecal Polyphenols|Amount of parent polyphenols and metabolites in feces was calculated by multiplying net concentrations by the amount of feces.|0 and 24 hours post‐dose.|||nmol||Standard Error|Mean
835543|NCT01288859|Primary|Urinary Excretion of Total Polyphenols|Area Under the Curve (AUC) from 0 to 24h of total polyphenols (sum of parent polyphenols and metabolites)was calculated using a trapezoidal rule applied to the urinary concentration-time curves of compounds.|Time intervals: 0-2, 2-4, 4-6, 6-8, 10-24 hours post‐dose.|Basing on power analysis calculation on a previous work||nmol•h/L||Standard Error|Mean
835544|NCT01288859|Primary|Serum Polyphenol Concentrations Over 24h From Food Consumption|Area Under the Curves (AUC) from 0 to 24h of parent polyphenols was calculated using a trapezoidal rule applied to the concentration-time curves of compounds.|0, 0.5, 1, 2, 4, 6, and 24 hours post‐dose|The number of subjects was based on power calculations derived from our previous study. We calculated that, at α = 0.05 with a power of 80%, 8 subjects would allow us to detect a 20% difference in serum and urinary concentrations of parental compounds, glucuronides and phenolic acids.||nmol*h/L||Standard Error|Mean
835545|NCT01288911|Secondary|Percentage of Participants With Adverse Events|"A serious adverse event was defined as any untoward medical occurrence that at any dose:
Resulted in death
Was life threatening
Resulted in persistent or significant disability/incapacity
Resulted in congenital anomaly or birth defect
Required inpatient hospitalization or led to prolongation of hospitalization
Other medically important events.
Treatment-related indicates adverse events assessed by the Investigator as probably or possibly related to study treatment."|From initiation of study drug up to 30 days after the last dose of study drug or the 30-day safety follow-up visit, whichever occurred last. Median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm.|Safety Analysis Set (all participants who had initiated at least 1 dose of study drug)||percentage of participants|||Number
835647|NCT01290224|Secondary|Toxicity (Other Than CIPN) Profile Associated With Scrambler Therapy as Measured by Common Terminology Criteria for Adverse Events (CTCAE) 4.0|CTCAE Grading: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death.|Day 1 to Day 10|||participants|||Number
835546|NCT01288911|Secondary|Percentage of Participants With an Objective Response|"Response assessments were reported by ICR for target lesions in soft tissues and non-target lesions in soft tissues based on CT and/or MRI according to RECIST version 1.1.
Objective response was defined as the number of participants achieving either a complete response (CR) or a partial response (PR) based on participant’s best overall response assessed at the end of the treatment."|From randomization until the data cutoff date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm.|Full analysis set||percentage of participants|||Number
835547|NCT01288911|Secondary|Radiographic PFS Based on ICR Assessment|"Radiographic PFS was calculated as the time interval from the date of randomization to the first date of radiographic disease progression.
Radiographic disease progression was defined as either a progression in soft tissue on CT/MRI scan according to RECIST 1.1, and/or a progression in bone lesions (a minimum of 2 new bone lesions as compared to previous scan) on bone scan and confirmed by the next bone scan."|From randomization until the data cutoff date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm.|Full analysis set||months||95% Confidence Interval|Median
835548|NCT01288911|Secondary|Time to ≥ 90% PSA Decline From Baseline|The time to ≥ 90% PSA decline from Baseline was defined as the time interval from the date of randomization to the first date a PSA decline from Baseline of at least 90% was recorded. In participants without ≥ 90% PSA decline from Baseline, the time to ≥ 90% PSA decline from Baseline was censored on the date of the last PSA sample taken. Participants who had no Baseline PSA and participants with no post-baseline PSA results were censored on the date of randomization|From randomization until the data cutoff date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm.|Full analysis set||months||95% Confidence Interval|Median
835549|NCT01288911|Secondary|Time to ≥ 50% PSA Decline From Baseline|The time to ≥ 50% PSA decline from Baseline was defined as the time interval from the date of randomization to the first date a PSA decline from Baseline of at least 50% was recorded. In participants without ≥ 50% PSA decline from Baseline, the time to ≥ 50% PSA decline from Baseline was censored on the date of the last PSA sample taken. Participants who had no Baseline PSA and participants with no post-baseline PSA results were censored on the date of randomization|From randomization until the data cutoff date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm.|Full analysis set||months||95% Confidence Interval|Median
835550|NCT01288911|Secondary|Time to ≥ 30% PSA Decline From Baseline|The time to ≥ 30% PSA decline from Baseline was defined as the time interval from the date of randomization to the first date a PSA decline from Baseline of at least 30% was recorded. In participants without ≥ 30% PSA decline from Baseline, the time to ≥ 30% PSA decline from Baseline was censored on the date of the last PSA sample taken. Participants who had no Baseline PSA and participants with no post-baseline PSA results were censored on the date of randomization|From randomization until the data cutoff date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm.|Full analysis set||months||95% Confidence Interval|Median
835551|NCT01288911|Secondary|Time to PSA ≤ 4 ng/mL|Time to PSA ≤ 4 ng/mL was defined as the time interval from the date of randomization to the first date a decline in PSA to a result of 4 ng/mL or below was recorded. In participants without PSA results ≤ 4 ng/mL, the time to PSA ≤ 4 ng/mL was censored on the date of the last PSA sample taken. Participants with a PSA result ≤ 4 ng/mL at Baseline, participants with no Baseline PSA and participants with no post-baseline PSA results were censored on the date of randomization|From randomization until the data cutoff date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm.|Full analysis set||months||95% Confidence Interval|Median
835552|NCT01288911|Secondary|Time to PSA Progression|Time to PSA progression was calculated as the time interval from the date of randomization to the date of first observation of PSA progression. PSA progression was defined as a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the nadir (or above the baseline value for patients who did not have a decline in PSA post-baseline values), and confirmed by a second consecutive PSA assessment at least 3 weeks later. For participants with no documented PSA progression, the time to PSA progression was censored on the date the last PSA sample was taken.|From randomization until the data cutoff date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm.|Full analysis set||months||95% Confidence Interval|Median
835553|NCT01288911|Secondary|Best Prostate-specific Antigen (PSA) Response|The best PSA response was defined as the percentage change from Baseline to the smallest PSA value after Baseline including PSA results from samples taken after the study drug was stopped. For participants with no decrease in PSA post-baseline, the best PSA response was the smallest increase in PSA. For participants with no post-baseline PSA values, the PSA response was set to missing. PSA was analyzed at a central laboratory.|Baseline to the data cutoff date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm.|Full analysis set with available PSA data||percent change||Full Range|Median
835554|NCT01288911|Secondary|Prostate-specific Antigen (PSA) Response by Week 13|The PSA response by Week 13 was defined as the percentage change from Baseline to the smallest PSA value after Baseline (i.e., a decrease of 100% represents the largest possible decrease to a value below the lower limit of quantification) and on or before day 99 (i.e., upper boundary of the Week 13 visit window). For participants with no decrease in PSA post-baseline by Week 13, the PSA response by Week 13 was the smallest increase in PSA up to day 99. For participants with no post-baseline PSA values up to day 99, the PSA response by Week 13 was set to missing. PSA was analyzed at a central laboratory.|Baseline to Week 13|Full analysis set with available PSA data||percent change||Full Range|Median
835568|NCT01289041|Secondary|Overall Survival (OS) According to PI3K Activation Pathway Status|Overall survival (OS) was defined as the time from start of treatment to the date of death due to any cause. If a patient is not known to have died, survival was censored at the last date of contact. OS was to be reported at extension and after 3-year follow-up. The Kaplan-Meier median was used to analyze the OS.|every 3 months|Full analysis set includes all patients who received at least one dose of study drug.||months||95% Confidence Interval|Median
836254|NCT01286740|Secondary|Plasma Concentration of RPV and EFV at Week 1|The mean (SD) plasma concentration (ng/mL) of RPV and EFV was measured at Week 1.|Week 1|Participants with evaluable measurements for plasma concentrations of RPV and EFV at Week 1 were analyzed.||ng/mL||Standard Deviation|Mean
835555|NCT01288911|Secondary|PFS Based on Investigator Assessment|"PFS was calculated as the time from randomization to the date of the first progression event detected. A progression event was defined as objective evidence of radiographic disease progression based on the assessments by investigators, skeletal-related event, initiation of new antineoplastic therapy or death by any cause, whichever occurred first.
Radiographic disease progression was defined as either a progression in soft tissue on CT/MRI scan according to RECIST 1.1, and/or a progression in bone lesions on bone scan (≥ 2 new bone lesions) confirmed by the next bone scan.
A skeletal-related event was defined as radiation therapy or surgery to bone, pathologic bone fracture, spinal cord compression or change in antineoplastic therapy to treat bone pain.
The initiation of new antineoplastic therapy included any new therapy for the treatment of disease progression after the study drug administration started."|From randomization until the data cut-off date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm.|Full analysis set||months||95% Confidence Interval|Median
835556|NCT01288911|Primary|Progression Free Survival (PFS) Based on Independent Central Review (ICR) Assessment|"PFS is the time from randomization to the date of the first progression event detected. A progression event was defined as objective evidence of radiographic disease progression based on the assessments by the ICR, skeletal-related event, initiation of new antineoplastic therapy or death by any cause, whichever occurred first.
Radiographic disease progression was defined as either a progression in soft tissue on computed tomography (CT)/magnetic resonance imaging (MRI) scan according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, and/or a progression in bone lesions on bone scan (≥ 2 new bone lesions) confirmed by the next bone scan.
A skeletal-related event was any radiation therapy or surgery to bone, pathologic bone fracture, spinal cord compression or change in antineoplastic therapy to treat bone pain.
The initiation of new antineoplastic therapy included any new therapy for the treatment of disease progression after the study drug administration started."|From randomization until the data cut-off date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm.|Full analysis set (all randomized participants)||months||95% Confidence Interval|Median
835557|NCT01289015|Secondary|Effective Treatment and Mycological Cure of Interdigital Tinea Pedis at Week 6|"Effective treatment of interdigital tinea pedis which is defined as negative KOH and negative dermatophyte culture and erythema, scaling, and pruritus scores of 0 or 1 (corresponding to absent and mild respectively).
Mycological cure of interdigital tinea pedis which is defined as negative KOH and negative dermatophyte culture."|Visit 4/ Week 6.|Full Analysis Set (FAS) using a Modified Intent to Treat population.||percentage of subjects|||Number
835558|NCT01289015|Primary|Complete Cure of Interdigital Tinea Pedis|"The primary efficacy comparison between NAFT-600 gel and placebo will be based on the percentage of subjects at Week 6 with complete cure of interdigital tinea pedis.
Complete cure is defined as negative mycology results (dermatophyte culture and KOH) and the absence of erythema, scaling, and pruritus."|Visit 4/ Week 6|Full Analysis Set (FAS) defined as the subset of all subjects in the Safety Evaluation Set (SES) with a positive mycology culture at baseline and for whom the primary efficacy variable is available. This was a modified intent to treat principle because culture results were not available before the start of treatment.||percentage of subjects|||Number
835559|NCT01289028|Secondary|Progression Free Survival (PFS) of the Patients Who Were Included Due to an Intolerability of a Prior Treatment.|Progression-free survival (PFS) is defined as the time from first study drug administration to objective tumor progression or death from any cause. If a patient has not had an event, PFS is censored at the date of last adequate tumor assessment.|during 12 months|||days||95% Confidence Interval|Median
835560|NCT01289028|Secondary|Overall Survival, Number of Events Related to Progression of the Disease|The OS rate could not be calculated due to the high number of censored cases. Number of censored, n (%) 108 (86.4). Only available data is number of events. OS was defined as the time from first study drug administration to death from any cause. If a patient was not known to have died, survival was censored at date of last contact.|during 12 months|||events|||Number
835561|NCT01289028|Secondary|Duration of Overall Response|The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence|during 12 months|||days||95% Confidence Interval|Median
835562|NCT01289028|Secondary|Time to Tumor Progression|Time to tumor progression defined as the time from start of treatment to observed tumor progression (censoring for death without progression) as stated in the original protocol was not evaluated as stated in section 9.8.3 of the clinical study report.|during the first 4 months|Time to tumor progression defined as the time from start of treatment to observed tumor progression (censoring for death without progression) as stated in the original protocol was not evaluated|||||
835563|NCT01289028|Secondary|Time to Overall Response (CR or PR): Per Protocol Population|Complete Response (CR): Disappearance of all target lesions, and Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter.|24 weeks and 52 weeks|||percentage of participants|||Number
835564|NCT01289028|Secondary|Analysis of Time to Overall Response (CR or PR) According to RECIST Using Kaplan-Meier Method for ITT Population|Complete Response (CR): Disappearance of all target lesions. and Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter.|24 weeks and 52 weeks|ITT population||percentage of participants|||Number
835565|NCT01289028|Primary|Percent of Patients Achieving Complete Response (CR)|Complete response (CR) is the Disappearance of all target lesions.|during the first 4 months|||percentage of participants|||Number
835566|NCT01289028|Primary|Percent of Patients Achieving Partial Response (PR)|The primary efficacy variable was defined as the proportion of patients with a best overall response of CR by Week 16/Month 4 based on local assessment according to RECIST (Version 1.0). This is an at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter.|during the first 4 months|ITT set, N=125||percentage of participants|||Number
835567|NCT01289028|Primary|Percent of Patients Achieving Stable Disease (SD)|Neither sufficient shrinkage to qualify for Partial Response nor sufficient increase to qualify for Progression Disease, taking as reference the smallest sum of the longest diameter since the treatment started.|During the first 4 months|||% participants|||Number
835641|NCT01289548|Secondary|Acute Rejection of Transplanted Kidney|biopsy-confirmed, clinically symptomatic|before discharge|All the patients completed the study and no dropout occured.||participants|||Number
835569|NCT01289041|Secondary|Progression Free Survival (PFS) According to PI3K Activation Pathway Status|PFS is defined as the time from start of treatment to the date of first documented progression or death due to any cause. If a patient has not had an event, PFS will be censored at the date of last adequate tumor assessment.|24 months|Full analysis set includes all patients who received at least one dose of study drug.||months||95% Confidence Interval|Median
835570|NCT01289041|Primary|Best Overall Response Rate (BORR) According to PI3K Activation Pathway Status|"BOR was determined based on investigator assessment of overall lesion response using RECIST criteria guidelines.
BOR = objective responses rate (ORR), disease control rate (DCR) or clinical benefit rate (CBR). ORR = (complete response (CR) or partial response(PR); DCR = (CR or PR or Stable disease (SD); CBR = (CR or PR od SD >= 24 weeks)"|24 months|Full analysis set includes all patients who received at least one dose of study drug.||number of participants|||Number
835571|NCT01289080|Secondary|The Abnormalities Found in Vital Signs, ECGs, and Clinical Laboratory Tests Are Reported as AEs Upon Study Physicians Discretion.|An adverse event (AE) was an exacerbation of an existing problem or any new problem, experienced by a participant when enrolled in a trial, whether or not it was considered drug related by the study physician.|AEs were recorded from Screening (ICF was signed) to Follow-up 31 (+ 2) days.|The dataset for all safety analyses consisted of the data from all enrolled participants who received at least 1 dose of study medication, regardless of any protocol deviation. All observed data for these subjects were included.||participants|||Number
835572|NCT01289080|Secondary|Fraction of the Systemically Available Brexpiprazole Metabolite (DM-3411) Excreted Into the Urine (fe,u).|Urine samples were collected at Predose and at intervals of 0 to 24, 24 to 48, 48 to 72, 72 to 96, 96 to 120, 120 to 144, and 144 to 168 hours postdose. Unbound fraction of drug in plasma was calculated as 100% - mean percent of brexpiprazole bound to plasma protein for each participant.|Day 1 to Day 8|The dataset for PK analysis of all evaluable brexpiprazole PK parameters consisted of enrolled participants who had evaluable plasma concentrations.||% of unbound brexpiprazole in urine.||Standard Deviation|Mean
835573|NCT01289080|Secondary|Renal Clearance (CLr) of Brexipiprazole Metabolite (DM-3411).|Urine samples were collected at Predose at intervals of 0 to 24, 24 to 48, 48 to 72, 72 to 96, 96 to 120, 120 to 144, and 144 to 168 hours postdose. Unbound fraction of drug in plasma was calculated as 100% - mean percent of brexpiprazole bound to plasma protein for each participant.|Day 1 to Day 8|The dataset for PK analysis of all evaluable brexpiprazole PK parameters consisted of enrolled participants who had evaluable plasma concentrations.||mL/h/kg||Standard Deviation|Mean
835574|NCT01289080|Secondary|Terminal-phase Elimination Half-life of Brexpiprazole (t1/2,z).|Blood samples were collected at Predose (within 15 minutes of dosing) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours or at ET. Unbound fraction of drug in plasma was calculated as 100% - mean percent of brexpiprazole bound to plasma protein for each participant.|Day 1 to Day 8|The dataset for PK analysis of all evaluable brexpiprazole PK parameters consisted of enrolled participants who had evaluable plasma concentrations. The terminal phase elimination half-life was not determined for DM-3411 metabolite.||h||Standard Deviation|Mean
835575|NCT01289080|Secondary|Apparent Unbound Clearance From Plasma After Extravascular Administration of Brexpiprazole (CLu/F).|Blood samples were collected at Predose (within 15 minutes of dosing) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours or at ET. Unbound fraction of drug in plasma was calculated as 100% - mean percent of brexpiprazole bound to plasma protein for each participant.|Day 1 to Day 8|The dataset for PK analysis of all evaluable brexpiprazole PK parameters consisted of enrolled participants who had evaluable plasma concentrations.||mL/h/kg||Standard Deviation|Mean
835576|NCT01289080|Secondary|Unbound Fraction of Brexpiprazole in Plasma (fu).|Blood samples were collected at Predose (within 15 minutes of dosing) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours or at ET. Unbound fraction of drug in plasma was calculated as 100% - mean percent of brexpiprazole bound to plasma protein for each participant.|Day 1 to Day 8|The dataset for PK analysis of all evaluable brexpiprazole PK parameters consisted of enrolled participants who had evaluable plasma concentrations.||% of unbound brexpiprazole in plasma||Standard Deviation|Mean
835577|NCT01289080|Secondary|Apparent Clearance From Plasma After Extravascular Administration of Brexpiprazole (CL/F).|The value of CL/F was determined as Dose/AUC∞. Clearance of a drug was a measure of the rate at which a drug was metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) was influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance was a quantitative measure of the rate at which a drug substance was removed from the blood.|Day 1 to Day 8|The dataset for PK analysis of all evaluable brexpiprazole PK parameters consisted of enrolled participants who had evaluable plasma concentrations.||mL/h/kg||Standard Deviation|Mean
835578|NCT01289080|Secondary|Time to Cmax of Brexiprazole Metabolite (DM-3411) (Tmax).|Blood samples were collected at Predose (within 15 minutes of dosing) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours or at ET. Tmax is the time taken to reach highest measured concentration of the drug during the dosing interval.|Day 1 to Day 8|The dataset for PK analysis of all evaluable brexpiprazole PK parameters consisted of enrolled participants who had evaluable plasma concentrations.||h||Full Range|Median
835579|NCT01289080|Secondary|Maximum Plasma Concentration of Brexpiprazole Metabolite (DM-3411) (Cmax).|Blood samples were collected at Predose (within 15 minutes of dosing) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours or at ET. Unbound fraction of drug in plasma was calculated as 100% - mean percent of brexpiprazole bound to plasma protein for each participant.|Day 1 to Day 8|The dataset for PK analysis of all evaluable brexpiprazole PK parameters consisted of enrolled participants who had evaluable plasma concentrations.||ng/mL||Standard Deviation|Mean
835580|NCT01289080|Secondary|AUC Time Curve of Brexpiprazole From Time Zero to Infinity (AUC∞).|Blood samples were collected at Predose (within 15 minutes of dosing) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours or at ET. The AUC∞ was estimated using the linear trapezoidal rule.|Day 1 to Day 8|The dataset for PK analysis of all evaluable brexpiprazole PK parameters consisted of enrolled participants who had evaluable plasma concentrations. AUC-time curve from zero to infinity (AUC∞) was not determined for DM-3411 metabolite.||ng*h/mL||Standard Deviation|Mean
837970|NCT01309919|Secondary|Satisfaction|Participant satisfaction with the IUD at 12 weeks post-insertion|12 weeks post-partum|We assessed satisfaction with the IUD of all participants who completed the 12-week follow up call||% of participants who received an IUD|||Number
835581|NCT01289080|Secondary|AUC Time Curve of Brexpiprazole Metabolite (DM-3411) Calculated to the Last Observable Concentration at Time t (AUCt).|Blood samples were collected at Predose (within 15 minutes of dosing) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours or at ET. The AUCt was estimated using the linear trapezoidal rule.|Day 1 to Day 8|The dataset for PK analysis of all evaluable brexpiprazole PK parameters consisted of enrolled participants who had evaluable plasma concentrations.||ng*h/mL||Standard Deviation|Mean
835582|NCT01289080|Primary|Unbound Maximum (Peak) Plasma Concentration of Brexpiprazole (Cmax,u).|Blood samples were collected at Predose (within 15 minutes of dosing) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours or at ET. Unbound fraction of drug in plasma was calculated as 100% - mean percent of brexpiprazole bound to plasma protein for each participant.|Day 1 to Day 8|The dataset for PK analysis of all evaluable brexpiprazole PK parameters consisted of enrolled participants who had evaluable plasma concentrations.||ng/mL||Standard Deviation|Mean
835583|NCT01289080|Primary|Unbound Area Under AUC- Time Curve From Time Zero to Infinity (AUC∞,u).|Blood samples were collected at Predose (within 15 minutes of dosing) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours or at ET. Unbound fraction of drug in plasma was calculated as 100% - mean percent of brexpiprazole bound to plasma protein for each participant.|Day 1 to Day 8|The dataset for PK analysis of all evaluable brexpiprazole PK parameters consisted of enrolled participants who had evaluable plasma concentrations.||ng*h/mL||Standard Deviation|Mean
835584|NCT01289080|Primary|Unbound Area Under the Concentration (AUC) Time Curve Calculated to the Last Observable Concentration Brexpiprazole (AUCt,u).|Blood samples were collected on Day 1 at Predose (within 15 minutes of dosing) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours Postdose or at Early Termination (ET). Unbound fraction of drug in plasma was calculated as 100% - mean percent of brexpiprazole bound to plasma protein for each participant.|Day 1 to Day 8|The dataset for pharmacokinetics (PK) analysis of all evaluable brexpiprazole PK parameters consisted of enrolled participants who had evaluable plasma concentrations.||nanograms*hours/mL (ng*h/mL)||Standard Deviation|Mean
835585|NCT01289119|Secondary|Percentage of Participants With a Decrease in HbA1c ≥2.0%|Clinical response was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 2.0% at Week 16.|Baseline and Week 16.|The full analysis set, consisting of all patients who received at least one dose of double-blind study drug and who had a baseline assessment and at least one post-baseline HbA1c assessment. Last observation carried forward was utilized.||percentage of participants|||Number
835586|NCT01289119|Secondary|Percentage of Participants With a Decrease in HbA1c ≥1.5%|Clinical response was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 1.5% at Week 16.|Baseline and Week 16.|The full analysis set, consisting of all patients who received at least one dose of double-blind study drug and who had a baseline assessment and at least one post-baseline HbA1c assessment. Last observation carried forward was utilized.||percentage of participants|||Number
835587|NCT01289119|Secondary|Percentage of Participants With a Decrease in HbA1c ≥1.0%|Clinical response was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 1.0% at Week 16.|Baseline and Week 16|The full analysis set, consisting of all patients who received at least one dose of double-blind study drug and who had a baseline assessment and at least one post-baseline HbA1c assessment. Last observation carried forward was utilized.||percentage of participants|||Number
835588|NCT01289119|Secondary|Percentage of Participants With a Decrease in HbA1c ≥ 0.5%|Clinical response was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 0.5% at Week 16.|Baseline and Week 16|The full analysis set, consisting of all patients who received at least one dose of double-blind study drug and who had a baseline assessment and at least one post-baseline HbA1c assessment. Last observation carried forward was utilized.||percentage of participants|||Number
835589|NCT01289119|Secondary|Percentage of Participants With HbA1c ≤7.5% at Week 16|Clinical response was assessed by the percentage of participants with HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) less than or equal to 7.5% at Week 16.|Week 16|The full analysis set, consisting of all patients who received at least one dose of double-blind study drug and who had a baseline assessment and at least one post-baseline HbA1c assessment. Last observation carried forward was utilized.||percentage of participants|||Number
835590|NCT01289119|Secondary|Percentage of Participants With HbA1c ≤7.0% at Week 16|Clinical response was assessed by the percentage of participants with HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) less than or equal to 7.0% at Week 16.|Week 16|The full analysis set, consisting of all patients who received at least one dose of double-blind study drug and who had a baseline assessment and at least one post-baseline HbA1c assessment. Last observation carried forward was utilized.||percentage of participants|||Number
835591|NCT01289119|Secondary|Percentage of Participants With HbA1c ≤6.5% at Week 16|Clinical response was assessed by the percentage of participants with HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) less than or equal to 6.5% at Week 16.|Week 16|The full analysis set, consisting of all patients who received at least one dose of double-blind study drug and who had a baseline assessment and at least one post-baseline HbA1c assessment. Last observation carried forward was utilized.||percentage of participants|||Number
835592|NCT01289119|Secondary|Change From Baseline in Body Weight|The change between body weight measured at Baseline and body weight measured at Weeks 8 and 16. The least squares means are derived from an ANCOVA model with treatment as a fixed effect, and baseline body weight as a covariate for the monotherapy, baseline body weight with baseline metformin dose as covariates for the add-on to metformin therapy, baseline body weight with baseline metformin therapy status and baseline pioglitazone dose as covariates for the add-on to pioglitazone therapy.|Baseline and Weeks 8 and 16.|The full analysis set, consisting of all patients who received at least one dose of double-blind study drug and who had a baseline assessment and at least one post-baseline weight assessment. Last observation carried forward was utilized.||kg||Standard Error|Least Squares Mean
835642|NCT01289548|Primary|Plasma Creatine Concentration of the Recipients|Plasma creatinine concentration before surgery, 1hour, 4hours, 24hours, 48hours and 72hours after the artery unclamping|within the first 3days after the operation|All patients completed the trial and no dropout occured.||μmol/l||Inter-Quartile Range|Median
835593|NCT01289119|Secondary|Percentage of Participants With Marked Hyperglycemia|Marked Hyperglycemia was defined as fasting plasma glucose greater than or equal to 200 mg/dL (11.1 mmol/L).|Randomization to Week 16.|The full analysis set, consisting of all patients who received at least one dose of double-blind study drug and who had a baseline assessment and at least one post-baseline assessment.||percentage of participants|||Number
835594|NCT01289119|Secondary|Change From Baseline in Fasting Plasma Glucose Over Time|The change from Baseline in fasting plasma glucose (FPG) at Weeks 4, 8, 12 and 16. Least squares means are derived from an ANCOVA model with treatment as a fixed effect, and baseline FPG as a covariate for the monotherapy, baseline FPG with baseline metformin dose as covariates for the metformin therapy, baseline FPG with baseline metformin therapy status and baseline pioglitazone dose as covariates for the pioglitazone therapy.|Baseline and Weeks 4, 8, 12 and 16.|The full analysis set, consisting of all patients who received at least one dose of double-blind study drug and who had a baseline assessment and at least one post-baseline FPG assessment. Last observation carried forward was utilized.||mmol/L||Standard Error|Least Squares Mean
835595|NCT01289119|Secondary|Change From Baseline in HbA1c Over Time|The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at Weeks 4, 8 and 12. Least squares means are derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect, and baseline HbA1c as a covariate for the monotherapy, baseline HbA1c with baseline metformin dose as covariates for the metformin therapy, baseline HbA1c with baseline metformin therapy status and baseline pioglitazone dose as covariates for the pioglitazone therapy.|Baseline and Weeks 4, 8 and 12.|The full analysis set, consisting of all patients who received at least one dose of double-blind study drug and who had a baseline assessment and at least one post-baseline HbA1c assessment. Last observation carried forward was utilized.||percentage glycosylated hemoglobin||Standard Error|Least Squares Mean
835596|NCT01289119|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 16. Least squares means are derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect, and baseline HbA1c as a covariate for the monotherapy, baseline HbA1c with baseline metformin dose as covariates for the metformin therapy, baseline HbA1c with baseline metformin therapy status and baseline pioglitazone dose as covariates for the pioglitazone therapy.|Baseline and Week 16.|The full analysis set, consisting of all patients who received at least one dose of double-blind study drug and who had a baseline assessment and at least one post-baseline HbA1c assessment. Last observation carried forward was utilized.||percentage glycosylated hemoglobin||Standard Error|Least Squares Mean
835597|NCT01289210|Secondary|Assess the Safety and Feasibility of the Combination Regimen.||Safety assessed throughout study period.||||||
835598|NCT01289210|Primary|Number of Participants Whose Tumors Responded to Treatment With Intratumoral Injection of VTX-2337 in Combination With Low-Dose Local Radiation.|Tumor response was assessed via CT scans of the chest, abdomen, pelvis or other medically appropriate imaging modality to evaluate all areas of disease. Cheson Criteria were used for calculation of response.|Tumor assessment conducted at 12 weeks and every 3-6 months thereafter|Subjects who completed the first 4 weeks of treatment (radiation + 3 VTX-2337 injections) were evaluable for tumor response and immune response. The study was closed due to slow accrual. 2 subjects were enrolled; 1 was evaluable for the primary endpoint, the other discontinued prematurely and was evaluated for safety only (a secondary endpoint).||participants|||Number
835599|NCT01280656|Secondary|Number of Participants With Any Adverse Events and Any Serious Adverse Events|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes.|Up to Week 72|The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria.||participants|||Number
835600|NCT01280656|Secondary|Percentage of Participants Who Discontinued Treatment Due to Adverse Events|The percentage of participants with treatment discontinuation rates due to adverse events (AE) between conventional group, peginterferon alfa-2a and peginterferon alfa-2b is presented.|Up to Week 48|The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria.||percentage of participants|||Number
835601|NCT01280656|Secondary|Percentage of Participants With Null Response or No Responder at End of Treatment|Null response or no responders were defined as those participants presenting positive viral load at EOT (regardless of the treatment duration). EOT= Week 48.|At Week 48|The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria.||percentage of participants|||Number
835602|NCT01280656|Secondary|Percentage of Participants With Virologic Relapse up to Week 72|Virologic relapse was defined as undetectable HCV-RNA at end of treatment and detectable HCV-RNA at the last follow-up assessment available. If the participant was a responder at end of treatment and was not submitted to any viral load assessment during the follow-up period, he was considered a relapser.|Up to Week 72|The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria. The analysis was performed in participants with virologic response at EOT in each group (16, 126, and 101 respectively).||percentage of participants|||Number
835603|NCT01280656|Secondary|Percentage of Participants With Virologic Response at End of Treatment|Virologic response at EOT was defined as undetectable HCV-RNA at EOT (regardless in which week treatment was concluded). EOT = Week 48.|At Week 48|The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria.||percentage of participants|||Number
835604|NCT01280656|Secondary|Percentage of Participants With Rapid Virologic Response at Week 4|Rapid virologic response was defined as qualitative or quantitative HCV-RNA (viral load) undetectable (below the lower limit of detection) at Week 4 of treatment period.|At Week 4|The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria.||percentage of participants|||Number
835643|NCT01289574|Secondary|Percent Change in Noninflammatory Acne Lesion Counts|Percent change from Baseline|12 weeks|All randomized subjects||Percentage change from baseline||Standard Deviation|Mean
835605|NCT01280656|Secondary|Mean Percentage Reduction of Hemoglobin in Treatment Responders and Treatment Non-Responders|The average percentage reduction of hemoglobin (Hb) in treatment responders and treatment non-responders between the conventional group, peginterferon alfa-2a plus and peginterferon alfa-2b is presented. Participants with undetectable HCV RNA at specified time points (Weeks 4/12/18/24/48) were considered as treatment responders. Participants with positive viral load (detectable HCV RNA) at end of treatment regardless of the treatment duration were considered as treatment non-responders.|Up to Week 72|The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria. Treatment responders and non-responders for whom data was available were considered for this outcome measure.||mean percentage reduction of hemoglobin||Standard Deviation|Mean
835606|NCT01280656|Secondary|Percentage of Participants Who Were Treated at Interferon Application Centers and at Home and Discontinued Treatment|The percentage of participants who were treated at interferon application centers and at home and who discontinued treatment is presented. Participants who did not have viral load assessment at Week 12 were considered treatment failures, except in the specific case where the lack of assessment was not due to treatment shortening in function of response guided therapy.|Up to Week 48|The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria. The analysis excluded participants treated at an unknown location (7/62, 10/312, and 23/286 respectively)||percentage of participants|||Number
835607|NCT01280656|Secondary|Percentage of Participants With Sustained Virologic Response Treated at Interferon Application Centers and Treated at Home|The percentage of participants with SVR-12 and SVR-24 treated at interferon application centers (IAC) and treated at home are presented.|At Week 60 (SVR 12) and Week 72 (SVR 24)|The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria. The analysis was performed in participants with virologic response at EOT in each group excluding participants treated at an unknown location (2/16, 5/126, and 9/101 respectively).||percentage of participants|||Number
835608|NCT01280656|Secondary|Percentage of Participants With Early Virologic Response at Week 12|An early virologic response (EVR) was defined as a HCV-RNA decrease of at least two logarithmic scales (2 Log) or 100 times the pretreatment value or non-detection at Week 12 of treatment period.|At Week 12|The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria.||percentage of participants|||Number
835609|NCT01280656|Secondary|Number of Participants With Interferon Dose Reduction Rates in Function of the Interferon Type Being Used|The number of participants with Interferon dose reduction rates in function of the interferon type being used are reported|At Week 24|The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria. The analysis was performed in the participants who were available for interferon dose reduction rates in each group (56, 302, and 280 respectively).||participants|||Number
835610|NCT01280656|Secondary|Percentage of Participants With Sustained Virologic Response at 24 Weeks After End of Treatment|SVR was defined as virological response at 24 weeks after EOT, EOT= Week 48. Virologic response was either defined as having undetectable (that is, no hepatitis C virus Ribonucleic acid [HCV RNA] was detected in the participants' plasma samples) or less than 50 IU/mL HCV RNA (that is, the participants' plasma samples contained traces of HCV RNA at a concentration below the limit of quantification of the viral load assay or no HCV RNA was detected in the samples). Participants who did not have viral load assessment at Week 12 were considered treatment failures, except in the specific case where the lack of assessment was not due to treatment shortening in function of response guided therapy.|At Week 72|The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria. The analysis was performed in participants with virologic response at EOT in each group (16, 126, and 101 respectively).||percentage of participants|||Number
835611|NCT01280656|Primary|Percentage of Participants With Sustained Virologic Response at 12 Weeks After End of Treatment|Sustained virological response (SVR) was defined as virological response at 12 weeks after end of treatment (EOT). Virologic response was either defined as having undetectable (that is, no hepatitis C virus Ribonucleic acid [HCV RNA] was detected in the participants’ plasma samples) or less than 50 international units/milliliter (IU/mL) HCV RNA (that is, the participants’ plasma samples contained traces of HCV RNA at a concentration below the limit of quantification of the viral load assay or no HCV RNA was detected in the samples). EOT= Week 48. Participants who did not have viral load assessment at Week 12 were considered treatment failures, except in the specific case where the lack of assessment was not due to treatment shortening in function of response guided therapy.|At Week 60|The intent-to-treat (ITT) population consisted of participants who fulfilled all inclusion/ exclusion criteria. The analysis was performed in participants with virologic response at EOT in each group (16, 126, and 101 respectively).||percentage of participants|||Number
835612|NCT01280695|Secondary|Change From Baseline in High Molecular Weight Adiponectin|To evaluate the effects of three different doses of MSDC-0602 and pioglitazone as compared to placebo on biomarkers of inflammatory status (high molecular weight adiponectin) following once-daily dosing for 28 consecutive days in patients with Type 2 diabetes.|Baseline and 28 days|The Per-Protocol Population included all patients who completed the 4-week, double blind treatment period without any major deviations from the protocol procedures.||ng/mL||Standard Error|Least Squares Mean
835613|NCT01280695|Secondary|Change in Fasting Plasma Insulin|To characterize the effects of 3 different doses of MSDC-0602 and pioglitazone as compared to placebo on insulin following once-daily dosing for 28 consecutive days|Baseline and 28 days|The Per-Protocol population included all patients who completed the 4-week, double blind treatment period without any major deviations from the protocol procedures.||µIU/mL||Standard Deviation|Least Squares Mean
835614|NCT01280695|Secondary|Change From Baseline in Hematocrit|To characterize the effects of three different doses of MSDC-0602 and pioglitazone as compared to placebo in hematocrit following once-daily dosing for 28 consecutive days in patients with Type 2 diabetes.|Baseline and 28 days|The Per-Protocol Population included all patients who completed the 4-week, double blind treatment period without any major deviations from the protocol procedures.||Change from baseline||Standard Error|Least Squares Mean
835615|NCT01280695|Secondary|Change From Baseline in Body Weight|To characterize the effects of three different doses of MSDC-0602 and pioglitazone as compared to placebo on hematocrit, body weight, and edema following once-daily dosing for 28 consecutive days in patients with Type 2 diabetes.|Baseline and 28 days|The Per-Protocol Population included all patients who completed the 4-week, double blind treatment period without any major deviations from the protocol procedures.||kg||Standard Error|Least Squares Mean
835616|NCT01280695|Secondary|Change From Baseline in HbA1c|To explore the drug effect difference in the reduction in hemoglobin A1c in response to three different doses of MSDC-0602 and pioglitazone (45 mg Actos®) as compared to placebo following once-daily dosing for 28 consecutive days in patients with Type 2 diabetes.|Baseline and 28 days|The Per-Protocol Population included all patients who completed the 4-week, double blind treatment period without any major deviations from the protocol procedures.||percentage of hemoglobin||Standard Error|Least Squares Mean
835617|NCT01280695|Primary|Change From Baseline in Fasting Plasma Glucose|To characterize the reduction in fasting plasma glucose in response to three different doses of MSDC-0602 Tablets as compared to placebo following once-daily dosing for 28 consecutive days in patients with Type 2 diabetes.|Baseline and 28 days|Per-Protocol Population:Included all patients who completed the 4-week, double blind treatment period without any major deviations from the protocol procedures. The Per-Protocol Population was used for all efficacy measurements.||mg/dL||Inter-Quartile Range|Median
835618|NCT01289392|Primary|Sleep Apnea|Number of events per hour of sleep|6 months|||number of events||Standard Deviation|Mean
835619|NCT01289392|Secondary|Inflammatory Markers|Blood samples to test: tumor necrosis factor-alpha (TNF-alpha), C-reactive protein (CRP), Interleukin-6 and Interleukin-8|6 months after the basal evaluation||||||
835620|NCT01289392|Primary|Objective Sleep Parameters|Polysomnographic date of sleep stages percentages, sleep efficiency, arousals, apnea-hypopnea index, oxyhemoglobin saturation|6 months after the basal evaluation||||||
835621|NCT01289418|Primary|the Occurrence of Serious Adverse Events (SAE)||6 months|||participants|||Number
835622|NCT01289418|Primary|Number of Participants Who Had Experienced a New Health Problem or the Worsening of an Existing Health Condition That Resulted in Work Absenteeism.||day 8, 15 and 29|||participants|||Number
835623|NCT01289418|Primary|Number of Participants Who Had Experienced a New Health Problem or the Worsening of an Existing Health Condition That Resulted in a Medical Consultation.||at day 8, 15 and 29|||participants|||Number
835624|NCT01289522|Secondary|Biomarkers||two years||||||
835625|NCT01289522|Secondary|Overall Survival||1 year||||||
835626|NCT01289522|Secondary|Progression-free Survival||1 year||||||
835627|NCT01289522|Secondary|Best Overall Response|Tumor response is evaluated every 6 weeks according to RECIST criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions, Stable Disease (SD); Best overall Response = CR + PR + SD.|12 weeks|2 patients not assessable for response at 12 weeks||percentage of Best overall ORR||95% Confidence Interval|Number
835628|NCT01289522|Secondary|Grade 1 to 5 Toxicity|All grade 1 to 5 toxicity are registered during treatment. Patients have weekly clinical and biological examination.|24 weeks (average)|||percentage of events|||Number
835629|NCT01289522|Primary|Objective Tumor Response Rate|"The objective tumor response rate is evaluated every 6 weeks according to RECIST criteria.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT-scan or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR."|12 weeks (after completion of the 4th cycle of chemotherapy)|||percentage of participants||95% Confidence Interval|Number
835630|NCT01289548|Secondary|Plasma Concentration of MDA in the Recipients|Plasma concentration of malondialdehyde (MDA) before the operation, 1hour, 4hours and 24hours after the artery unclamping in the recipients|within the first 24hours after the operation|All patients completed the trial and no dropout occured.||nmol/ml||Inter-Quartile Range|Median
835631|NCT01289548|Secondary|Plasma Concentration of SOD in the Recipients|Plasma concentration of superoxide dismutase (SOD) before the operation, 1hour, 4hours and 24hours after the artery unclamping in the recipients|within 24hours after the operation|All patients completed the trial and no dropout occured.||U/ml||Inter-Quartile Range|Median
835632|NCT01289548|Secondary|Urine Concentration of RBP Postoperatively in the Recipients|Urine concentration of retinol binding protein (RBP) 1hour, 4hours and 24hours after the artery unclamping in the recipients|within the first 24hours after the artery unclamping|All patients completed the trial and no dropout occured.||mg/L||Inter-Quartile Range|Median
835633|NCT01289548|Secondary|Urine Concentration of RBP Preoperatively in the Recipients|Urine concentration of retinol binding protein (RBP) before the operation in the recipients|before the operation|No urine could be obtained from the other 46 patients because of anuria.||mg/L||Standard Deviation|Mean
835634|NCT01289548|Secondary|Urine Concentration of NAG Postoperatively in Recipients|Urine concentration of N-acetyl-D-glucosaminidase (NAG) 1hour, 4hours and 24hours after the artery unclamping in the recipients|within the first 24hours after the artery unclamping|All patients completed the trial and no dropout occured.||U/L||Inter-Quartile Range|Median
835635|NCT01289548|Secondary|Urine Concentration of NAG Preoperatively in Recipients|Urine concentration of N-acetyl-D-glucosaminidase (NAG) before the operation|before operation|Urine could not be obtained from the other 46 patients because of anuria.||U/L||Standard Deviation|Mean
835636|NCT01289548|Secondary|Total Costs During the Hospitalization|Total costs from the admission to the discharge of the recipients|from the admission to the discharge of the patients|All the patients completed the study and no dropout occured.||RMB yuan||Inter-Quartile Range|Median
835637|NCT01289548|Primary|Plasma Concentration of NGAL in the Recipients|Plasma concentration of neutrophil gelatinase-associated lipocalin (NGAL) before the operation and 24hours after the artery unclamping|within the first 24hours after the operation|All patients completed the trial and no dropout occured.||ng/ml||Inter-Quartile Range|Median
835638|NCT01289548|Primary|Urinary Output of the Recipients Postoperatively|Accumulated urinary output 1hour, 4hours and 24hours after the artery unclamping and the urinary output on the 2nd and 3rd day after the operation|within the first 3days after the operation|All patients completed the trial and no dropout occured.||ml||Inter-Quartile Range|Median
835639|NCT01289548|Secondary|Length of Postoperative Hospital Stay|time from the day of operation to the day of discharge for the recipients|before discharge|All the patients completed the study and no dropout occured.||day||Inter-Quartile Range|Median
835640|NCT01289548|Secondary|Delayed Graft Function|Delayed Graft Function according to the clinical symptoms|before discharge|All the patients completed the study and no dropout occured.||participants|||Number
835648|NCT01290224|Secondary|Percent Change From Day 1 at Week 10 in CIPN Symptom Bother as Measured by 8 CIPN Symptom Questions|The intensity of symptom was measured in a likert scale: none at all (0), a little bit (1), quite a bit (2) and very much (3). Percent change from day 1 at week 10 for each patient was calculated and average of percentage was reported.|Day 1 and Week 10|||percentage of a scale||Standard Deviation|Mean
835649|NCT01290224|Secondary|Percentage of Reduction at Weeks 10 From Week 1 in CIPN Symptoms as Measured by the North Central Cancer Treatment Group (NCCTG) Peripheral Neuropathy Question|The NCCTG peripheral neuropathy question range: 0 (No numbness or tingling or pain in fingers and/or toes) to 10 (Numbness, tingling or pain in fingers and/pr toes as bad as you can imagine). The question assessed the intensity of numbness, tingling or pain in toes or feet in the past week.|Week 1 and Week 10|||percentage of reduction in symptom||Standard Deviation|Mean
835650|NCT01290224|Secondary|Percentage of Reduction at Days 10 From Day 1 in Each of the 12 CIPN Measurement Questions in the Daily Therapy Questionnaire|The 12 CIPN symptoms individual question range: 0 (none) to 10 (as bad as can be). The questions assessed the intensity of numbness, tingling, or pain in toes or feet that patients have had right now (RN), at its worst over the past 24 hours (WP24H), and on average over the past 24 hours (AvgP24H).|Day 1 and Day 10|||percentage of reduction in symptom||Standard Deviation|Mean
835651|NCT01290224|Secondary|Average Change of CIPN Symptoms Between Sham Procedure and Scrambler Therapy as Measured by Each Individual Question|The 12 CIPN symptoms individual question range: 0 (none) to 10 (as bad as can be). The questions assessed the intensity of numbness, tingling, or pain in toes or feet that patients have had right now (RN), at its worst over the past 24 hours (WP24H), and on average over the past 24 hours (AvgP24H). Averaged change between day 1 and day 2 across 10 patients was calculated.|On days 1 and 2|||units on a scale||Standard Deviation|Mean
835652|NCT01290224|Primary|Percentage of Patients Who Have at Least a 50% Reduction (i.e., Success) in at Least 1 of the First 12 Chemotherapy Induced Peripheral Neuropathy (CIPN) Measurement Questions in the Pre/Post Therapy Questionnaire|CIPN measurement items score range: 0 (none) to 10 (as bad as can be). The questions assessed the intensity of numbness, tingling, or pain in toes or feet that patients have had right now, at its worst over the past 24 hours, and on average over the past 24 hours.|On days 1 and 2|||Percentage of Participants|||Number
835653|NCT01290263|Primary|AMG 386 Dose Limiting Toxicity (DLT) [Cohort B Phase I]|A DLT is defined as an adverse event that (a) is related to the AMG 386 and/or bevacizumab with an attribution of possible, probable, or definite, and (b) occurs during and/or begins during the first 28 days of the study treatment, and (c) meets any of the following criteria: >= grade 3 thrombocytopenia; grade 4 neutropenia lasting > 7 days; grade 4 anemia lasting > 7 days despite transfusion or growth factors; febrile neutropenia if ANC<0.5x10^9/L; clinically significant grade 3 non-hematologic toxicity despite maximal medical therapy lasting > 7 days, with the exception of grade 3 proteinuria which was considered a DLT if lasting > 14 days; grade 3 non-hematologic toxicity resulting in study drug discontinuation; grade 4 non-hematologic toxicity; >= grade 1 new CNS hemorrhage; >= grade 2 non-CNS hemorrhage.|Participants were assessed weekly while on study; the observation period for DLT evaluation was the first 28 days of study treatment.|All phase I Cohort B participants who completed 28 days on study treatment were evaluable. A participant was replaceable if they are taken off of study treatment due to progressive disease or withdrawal from study during before they completed the 28 day DLT period.||participants|||Number
835654|NCT01290263|Secondary|Progression-Free Survival (PFS) [Cohort A and Cohort B]|PFS based on Kaplan-Meier is defined as the time from study entry to the earliest documentation of disease progression or death. Progressive disease was established based on Response Assessment in Neuro-Oncology (RANO) criteria (Wen et al JCO 2010).|Disease was assessed radiographically to document clinical progression every cycle on treatment and post-treatment every 8 weeks. On Cohort A and B participants were followed for progression up to 36 days and 166 days.|All participants who received at least one dose of the study drug were evaluable for PFS.||days||Full Range|Median
835655|NCT01290263|Secondary|Overall Survival (OS) [Cohort A and Cohort B]|OS based on Kaplan-Meier is defined as the time from study entry to death or date last known alive.|Participants were followed long-term for survival every 3 to 4 months from the end of treatment until death or lost to follow-up. On Cohort A and B participants were followed up to 554 days and 442 days.|All participants who received at least one dose of the study drug were followed for OS.||days||Full Range|Median
835656|NCT01290263|Secondary|Best Radiographic Response [Cohort A and Cohort B]|Radiographic response was established based on Response Assessment in Neuro-Oncology (RANO) criteria (Wen et al JCO 2010) with 5 potential categories: Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive disease (PD) and Unknown status. CR: disappearance of all enhancing lesions, stable or improved non-enhancing lesions, and stable or improved clinically. PR: >= 50% decrease in sum of perpendicular diameters of all measurable enhancing lesions, no progression of non-measurable disease, stable or improved non- enhancing lesions, and stable or improved clinically. PD: > 25% increase in sum of perpendicular diameters of all measurable enhancing lesions, significant increase of non-enhancing lesions, any new lesions, clear clinical deterioration, failure to return for evaluation due to death or deteriorating condition. SD: does not qualify for CR, PR or PD, stable non-enhancing lesions, and stable clinically.|Disease was assessed radiographically for response every 8 weeks.|All participants who received at least one dose of the study drug were evaluable for response.||participants|||Number
835657|NCT01290263|Primary|AMG 386 Maximum Tolerated Dose (MTD) [Cohort B Phase I]|The MTD of weekly AMG 386 intravenously (IV) in combination with bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle is determined by the number of participants who experience a dose limiting toxicity (DLT). See subsequent primary outcome measure for the DLT definition. The MTD is defined as the highest dose at which fewer than one-third of patients experience a DLT. If no DLTs are observed, the MTD is not reached but the highest dose received may be the Recommended Phase II Dose (RP2D).|Participants were assessed weekly while on study; the observation period for MTD evaluation was the first 28 days of study treatment.|All phase I Cohort B participants who received at least one dose of the study drug were evaluable for MTD. A participant was replaceable if they are taken off of study treatment due to progressive disease or withdrawal from study during before they completed the 28 day DLT period.||mg/kg intravenously on days 1 and 15|||Number
836255|NCT01286740|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 (FDA Snapshot Analysis)|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the FDA snapshot analysis.|Week 48|Full Analysis Set||percentage of participants|||Number
835658|NCT01290263|Primary|6-Month Progression-Free Survival (PFS6) [Cohort A and Cohort B]|PFS6 is the proportion of patients remaining alive and progression-free at 6-months from study entry. Progressive disease was established based on Response Assessment in Neuro-Oncology (RANO) criteria (Wen et al JCO 2010). RANO criteria has 5 potential categories: Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive disease (PD) and Unknown status. CR: disappearance of all enhancing lesions, stable or improved non-enhancing lesions, and stable or improved clinically. PR: >= 50% decrease in sum of perpendicular diameters of all measurable enhancing lesions, no progression of non-measurable disease, stable or improved non- enhancing lesions, and stable or improved clinically. PD: > 25% increase in sum of perpendicular diameters of all measurable enhancing lesions, significant increase of non-enhancing lesions, any new lesions, clear clinical deterioration, failure to return for evaluation due to death or deteriorating condition. SD: d|6 months|||proportion of participants||95% Confidence Interval|Number
835659|NCT01290341|Secondary|Effective Treatment and Mycological Cure of Interdigital Tinea Pedis at Week 6|"Effective treatment of interdigital tinea pedis which is defined as negative KOH and negative dermatophyte culture and erythema, scaling, and pruritus scores of 0 or 1 (corresponding to absent and mild respectively).
Mycological cure of interdigital tinea pedis which is defined as negative KOH and negative dermatophyte culture."|Visit 4/ Week 6|Full Analysis Set (FAS) using a Modified Intent to Treat (MITT) population.||percentage of subjects|||Number
835660|NCT01290341|Primary|Complete Cure of Interdigital Tinea Pedis|"The primary efficacy comparison between NAFT-600 gel and placebo will be based on the percentage of subjects at Week 6 with complete cure of interdigital tinea pedis.
Complete cure is defined as negative mycology results (dermatophyte culture and KOH) and the absence of erythema, scaling, and pruritus."|Visit 4/ Week 6|Full Analysis Set (FAS) defined as the subset of all subjects in the Safety Evaluation Set (SES) with a positive mycology culture at baseline and for whom the primary efficacy variable is available. This was a modified intent to treat principle because the culture results were not available before the start of treatment.||percentage of subjects|||Number
835661|NCT01290484|Primary|Change in Volume of Lymphatic Malformation|Participants were given sildenafil for 20 weeks. Participants weighing more than 20 kg were given 20 mg 3 times daily (60 mg/day). Participants weighing between 8 kg and 20 kg were given 10 mg 3 times daily (30 mg/day).|Baseline, 20 weeks|||percentage of volume change|||Number
835662|NCT01290523|Secondary|Radiographic Response by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1||6 months|||participants|||Number
835663|NCT01290523|Primary|Number of Participants With Adverse Events|Adverse events of treatment with TheraSphere Yttrium-90 glass microspheres will be assessed within 6 months of treatment administration. Anticipated adverse events may include liver dysfunction, gastrointestinal ulcer formation, cholecystitis, pneumonitis, fatigue, nausea/vomiting, abdominal pain|6 months|||participants|||Number
835664|NCT01290536|Secondary|Radiographic Response|Radiographic response of treated lesions on cross-sectional imaging (computed tomography or magnetic resonance imaging) following treatment with Yttrium-90 glass microspheres (TheraSphere) was assessed based on Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), no change in target lesions; Progressive Disease (PD), increase in target lesions.|6 months after treatment|Response data are presented by primary disease sites: Colorectal (mCRC), Neuroendocrine (NET), and all other tumors. One patient with mCRC did not have follow-up cross-sectional imaging. Therefore, radiographic response data was available for 20 of 21 patients with mCRC.||participants|||Number
835665|NCT01290536|Primary|Number of Participants With Adverse Events|Adverse effects of treatment with Yttrium-90 glass microspheres (TheraSphere) were collected prospectively for 6 months after each treatment administration.|6 months|||participants|||Number
835666|NCT01290614|Secondary|Number of Participants With PTH Measurement During the Study Period|The primary process outcome was measurement of PTH during the study period.|one year|||participants|||Number
835667|NCT01290614|Primary|Systolic Blood Pressure (SBP)|Average SBP for those with a baseline BP > 130/80|one year|Baseline blood pressure >130/80 mmHg||mmHg||Standard Deviation|Mean
835668|NCT01290627|Primary|Normalized Lateral Patella Contact Point Translation|"full extension to maximum flexion. The position of the patellar contact point was determined by locating the closest point to the femur on the patella throughout flexion. There are 2 patello-femoral contact points: a point on the medial aspect of the patella and a point on the lateral aspect of the patella. Throughout flexion, the lateral contact point generally moves closer to the top of the patella (hence, the positive value for the results). The translation of this contact point is normalized to report a ratio between -1 and 1. In other words, the distance the point has traveled compared to the total height of the patella. For example, if the patella is 8 cm in height and the point travels approximately 2 cm upwards during flexion, the value would be reported as +2/8 = +0.25. Definition of normalized: multiply (a series, function, or item of data) by a factor that makes the norm or some associated quantity such as an integral equal to a desired value (usually 1)."|Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.|||ratio of patella height|Participants|Standard Deviation|Mean
835669|NCT01290627|Primary|Normalized Medial Patella Contact Point Translation|"full extension to maximum flexion. The position of the patellar contact point was determined by locating the closest point to the femur on the patella throughout flexion. There are 2 patello-femoral contact points: a point on the medial aspect of the patella and a point on the lateral aspect of the patella. Throughout flexion, the medial contact point generally moves closer to the top of the patella (hence the positive value for the results). The translation of this contact point is normalized to report a ratio between -1 and 1. In other words, the distance the point has traveled compared to the total height of the patella. For example, if the patella is 8 cm in height and the point travels approximately 2 cm upwards during flexion, the value would be reported as +2/8 = +0.25. Definition of normalized: multiply (a series, function, or item of data) by a factor that makes the norm or some associated quantity such as an integral equal to a desired value (usually 1)."|Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.|||ratio of patella height|Participants|Standard Deviation|Mean
835670|NCT01290627|Primary|Patella Tilt With Respect to Femur|full extension to maximum flexion|Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.|||degrees|Participants|Standard Deviation|Mean
835671|NCT01290627|Primary|Patella Rotation With Respect to Femur|Patellar rotation from full extension to maximum flexion. A positive measurement of patellar rotation refers to positive flexion of the patella about the medial-lateral axis, where the patella component rotates so that the top of the patella rotates toward the femur and the bottom rotates away. Conversely, a negative measurement refers to negative flexion of the patella about this axis, where the patellar component rotates so that the top of the patella moves away from the femur and the bottom moves towards.|Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.|||degrees|Participants|Standard Deviation|Mean
835672|NCT01290627|Primary|Patella Flexion With Respect to Femur|Full extension to maximum flexion.|Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.|||degrees|Participants|Standard Deviation|Mean
835673|NCT01290640|Primary|In Vivo Angular Kinematics for Fixed-bearing and Rotating Platform (RP) TKA System During 4 Weight-bearing Activities.|"Angular kinematics for fixed bearing and rotating platform TKA system - Axial Rotation
The values that were reported indicate the rotation of the femur atop the tibial tray from the start of the activity to the end of the activity. If the femur rotated externally (posterior rollback of the lateral condyle, generally pivoted about the medial condyle), the number was reported as positive. If the femur rotated internally (anterior slide of the lateral condyle, generally pivoted about the medial condyle), the number was reported as negative."|March 2013|||degrees|Participants|Standard Deviation|Mean
835674|NCT01290640|Primary|In Vivo Linear Kinematics for Fixed-bearing and Rotating Platform (RP) TKA System During 4 Weight-bearing Activities.|The values that were reported indicate the motion of the contact point from the start of the activity to the end of the activity. If the point translated forward (anteriorly) atop the tibial tray, the number was reported as positive. If the point traveled backwards (posteriorly) atop the tibial tray, the number was reported as negative.|March 2013|Per protocol.||mm|Participants|Standard Deviation|Mean
835675|NCT01290666|Secondary|Duration of Drainage Post Procedure||Follow up out to 12 months post procedure||||||
835676|NCT01290666|Primary|Fistula Closure||12 months post procedure|||participants|||Number
835677|NCT01290679|Secondary|Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) for Time Missed From Work Due to Hepatitis C Virus (HCV) Infection and Its Treatment|Hours missed from work because of HCV infection or its treatment was assessed by measuring the change from baseline in the Work Productivity and Activity Impairment (WPAI): Hepatitis C questionnaire Absenteeism score (time missed from work). The possible WPAI WPAI absenteeism score range from baseline to Week 60 was 0-6000 and to Week 72 was 0-7200, with the higher scores indicating more impairment in WPAI absenteeism. The average WPAI absenteeism score from baseline to Week 60/72 was calculated for each participant and then the average of those values calculated for each treatment group. The area under the curve (AUC60/AUC72) over time from baseline to Week 60/72 was derived from a piecewise-linear model allowing the slopes to change at Week 4, 12, 24, 36, 48 and 60. The null hypothesis was there is no statistically significant difference between the treatment arms in the area under the curve (AUC) from baseline to Week 72 (AUC72) in WPAI absenteeism score.|Baseline to Week 60 and Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Scores on a scale*weeks||95% Confidence Interval|Least Squares Mean
835678|NCT01290679|Secondary|Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) for Impairment in Daily Activities Due to Hepatitis C Virus (HCV) Infection and Its Treatment|Impairment in daily activity was measured using the Work Productivity and Activity Impairment (WPAI): Hepatitis C questionnaire, Question 6. The possible impairment in WPAI daily activity score range from baseline to Week 60 was 0-6000 and to Week 72 was 0-7200, with the higher scores indicating more impairment in daily activities. The average WPAI impairment in daily activity score from baseline to Week 72 was calculated for each participant and then the average of those values were calculated to show the average WPAI impairment in daily activity score for each treatment group. The null hypothesis was there is no statistically significant difference between the treatment arms in the AUC for the change from baseline to Week 72 (AUC72) in WPAI impairment in daily activity scores. The Table below shows the WPAI Impairment in daily activity scores at Week 72 (as well as at Week 60) and the statistical analysis between treatment groups.|Baseline to Week 60 and Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Scores on a scale*weeks||95% Confidence Interval|Least Squares Mean
835679|NCT01290679|Secondary|Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) for Impairment in Overall Work Productivity Due to Hepatitis C Virus (HCV) Infection and Its Treatment|Impairment in overall work productivity was measured using the Work Productivity and Activity Impairment (WPAI): Hepatitis C questionnaire completed by participants throughout the study. WPAI Overall Productivity Scores ranged from 0% to 100% (higher WPAI scores indicated greater impairment in productivity). The average WPAI score from baseline to Week 72 was calculated for each participant and then the average of those values were calculated to show the average WPAI score for each treatment group. The null hypothesis was there is no statistically significant difference between the treatment groups in the AUC for the change from baseline to Week 72 (AUC72) in WPAI Productivity Scores. The Table below shows WPAI Productivity Scores at Week 72 (as well as at Week 60) from the model used to calculate the AUC and the statistical comparison between treatment groups.|Baseline to Week 60 and Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Scores on a scale*weeks||95% Confidence Interval|Least Squares Mean
835692|NCT01290679|Secondary|Percentage of Participants With On-treatment Failure|The table below shows percentage of participants with on-treatment failure defined as confirmed detectable Hepatitis C virus ribonucleic acid levels at actual end of treatment.|Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
835706|NCT01290679|Secondary|Change From Baseline in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)|The table below shows changes from baseline in log10 HCV RNA.|Day 3, Week 1, Week 4, Week 12, Week 24, and Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||log10 IU/mL||Standard Error|Mean
835680|NCT01290679|Secondary|Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) for the Fatigue Severity Scale (FSS) Total Scores|Study participants completed FSS questionnaires during study visits before treatment and throughout follow-up to rate the severity and impact of fatigue experienced in the preceding 2 weeks. FSS total scores are the average of nine questions with a range from 1 [no fatigue] to 7 [worst fatigue]; the possible score range from baseline to Week 60 would be 60-420 and to Week 72 would be 72-504. The average FSS total score from baseline to Week 60 and to Week 72 was calculated for each participant and then the average of those values were calculated to show the average FSS total score for each treatment group. The null hypothesis was that there would be no difference between the treatment arms in the FSS total score. The Table below shows the lease squares (LS) mean estimates of the area under the curve (AUC) at Week 72 (as well as at Week 60) and the statistical comparison between treatment groups.|Baseline to Week 60 and Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Scores on a scale*weeks||95% Confidence Interval|Least Squares Mean
835681|NCT01290679|Secondary|Plasma Concentration of TMC435: Systemic Clearance (CL)|The table below shows the mean (standard deviation) of CL values of TMC435. NOTE: the pre-dose CL values taken at Weeks, 2, 4, 8, and 12 were averaged and then the mean values from all participants were averaged to provide the final value reported below.|At protocol-specified time points at Weeks 2, 4, 8, and 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||L/h||Standard Deviation|Mean
835682|NCT01290679|Secondary|Plasma Concentration of TMC435: Predose Plasma Concentration (C0h)|The table below shows the mean (standard deviation) of C0h values of TMC435. NOTE: the timing of collection of blood samples post-dose for analysis at Week 2, 4, 8, and 12 was not specifed; only the interval was between blood samples was specified (ie, 2 samples collected 2 hours apart at Week 2, 4, 8, and 12).|Blood samples tested were taken before administration of TMC435 and at 2 random time points after dosing (taken atleast 2 hours apart from each other) at Week 2, 4, 8, and 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||ng/mL||Standard Deviation|Mean
835683|NCT01290679|Secondary|Plasma Concentration of TMC435: Area Under the Plasma Concentration-time Curve From the Time of Administration to 24 Hours After Dosing (AUC24h)|The table below shows the mean (standard deviation) values of the area under the plasma concentration-time curve from time of administration to 24 hours after dosing for TMC435.|At protocol-specified time points from the time of administration up to 24 hours after dosing at Weeks 2, 4, 8, and 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||ng*h/mL||Standard Deviation|Mean
835684|NCT01290679|Secondary|Median Time to Normalization of Alanine Aminotransferase (ALT) Levels|The table below shows the median time in weeks to normalization of ALT levels.|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Weeks||95% Confidence Interval|Median
835685|NCT01290679|Secondary|The Percentage of Participants With Normalization of Alanine Aminotransferase (ALT)|The percentage of participants analyzed were those with baseline ALT values out of the normal range (ie, 164 of 257 participants in the TMC435 treatment group and 79 of 134 participants in the Placebo group had ALT values at baseline that were out of the normal range.). Normalization of ALT values means that ALT values out of the normal range returned to within the normal range.|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
835686|NCT01290679|Secondary|Time From End-of-treatment to Viral Relapse|The table below shows the mean number of days to viral relapse, defined as participants having confirmed detectable plasma level of Hepatitis C Virus (HCV) ribonucleic acid (RNA) during the follow-up period in participants with undetectable plasma HCV RNA (<25 IU/mL undetectable) at the end of treatment.|Up to Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Days||Standard Error|Mean
835687|NCT01290679|Secondary|The Percentage of Participants With Viral Breakthrough at Different Time Points|The table below shows the percentage of participants at different time points with viral breakthrough, defined as a confirmed increase of greater than 1 log10 IU/mL in plasma HCV ribonucleic acid (RNA) level from the lowest level reached (ie, lowest value measured in between baseline and current value), or a confirmed plasma HCV RNA level of greater than 100 IU/mL in participants whose plasma HCV RNA had previously been below the limit of quantification (25 IU/mL detectable) or undetectable (<25 IU/mL undetectable).|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
835688|NCT01290679|Secondary|Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <1000 IU/mL|The table below shows the median time in days to reach HCV RNA levels <1000 IU/mL.|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Days||95% Confidence Interval|Median
835689|NCT01290679|Secondary|Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <100 IU/mL|The table below shows the median time in days to reach HCV RNA levels <100 IU/mL.|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Days||95% Confidence Interval|Median
835690|NCT01290679|Secondary|Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable|The table below shows the median time in days to reach HCV RNA levels <25 IU/mL undetectable.|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Days||95% Confidence Interval|Median
835691|NCT01290679|Secondary|Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable or Detectable|The table below shows the median time in days to reach HCV RNA levels <25 IU/mL undetectable or detectable.|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Days||95% Confidence Interval|Median
835693|NCT01290679|Secondary|Percentage of Participants Who Completed All Study Treatment at Week 24 Because of the Treatment Duration Rule|The table below shows the percentage of participants in the TMC435 treatment group who met the treatment duration rule (ie, having hepatitis C virus [HCV] ribonucleic acid [RNA] levels <25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA levels at Week 12) and completed treatment with PegIFNα-2a and RBV for 24 weeks. Participants in the TMC435 treatment group not meeting RGT criteria and participants in the placebo group were treated with PegIFNα-2a and RBV treatment for 48 weeks.|Week 24|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
835694|NCT01290679|Secondary|Percentage of Participants With Viral Relapse|The table below shows the percentage of participants with viral relapse, defined as having confirmed detectable plasma level of Hepatitis C virus (HCV) ribonucleic acid (RNA) during the follow-up period in participants with undetectable plasma HCV RNA (<25 IU/mL undetectable) at the end of treatment.|Up to Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
835695|NCT01290679|Secondary|Percentage of Participants With Viral Breakthrough|The table below shows the percentage of participants with viral breakthrough, defined as a confirmed increase of greater than 1 log10 IU/mL in plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) level from the lowest level reached (ie, lowest value measured in between baseline and current value), or a confirmed plasma HCV RNA level of greater than 100 IU/mL in participants whose plasma HCV RNA had previously been below the limit of quantification (25 IU/mL detectable) or undetectable (<25 IU/mL undetectable).|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
835696|NCT01290679|Secondary|Percentage of Participants With Partial Response|The table below shows the percentage of participants with partial response, defined as =>2 log10 reduction in Hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 compared to baseline, but not achieving undetectable HCV RNA while on treatment.|Week 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
835697|NCT01290679|Secondary|Percentage of Participants With Null Response|The table below shows the percentage of participants with null response, defined as <2 log10 reduction in Hepatitis C virus ribonucleic acid at Week 12 compared to baseline.|Week 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
835698|NCT01290679|Secondary|Percentage of Participants With in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels >1000 IU/mL at Week 4|The table below shows the percentage of participants in each treatment group with HCV RNA levels >1000 IU/mL at Week 4.|Week 4|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
835699|NCT01290679|Secondary|The Percentage of Participants With <1 log10 Decrease in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) From Baseline at Week 4|The table below shows the percentage of participants in each treatment group with <1 log10 HCV RNA decrease at Week 4.|Week 4|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
835700|NCT01290679|Secondary|The Percentage of Participants Achieving a Extended Rapid Virologic Response (eRVR)|The table below shows the percentage of participants in each treatment group who had a eRVR, defined as having undetectable plasma Hepatitis C Virus ribonucleic acid levels at Week 4 and 12.|Weeks 4 and 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
835701|NCT01290679|Secondary|The Percentage of Participants Achieving a Complete Early Virologic Response (cEVR)|The table below shows the percentage of participants in each treatment group who had a cEVR, defined as having undetectable plasma Hepatitis C Virus ribonucleic acid levels at Week 12.|Week 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
835702|NCT01290679|Secondary|The Percentage of Participants Achieving a Early Virologic Response (EVR)|The table below shows the percentage of participants who achieved an EVR, defined as having a change from baseline in plasma Hepatitis C virus ribonucleic acid of 2 log10 at Week 12.|Week 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
835703|NCT01290679|Secondary|The Percentage of Participants Achieving a Rapid Virologic Response (RVR)|The table below shows the percentage of participants in each treatment group who achieved a RVR, defined as having undetectable plasma Hepatitis C virus ribonucleic acid levels after receiving 4 weeks of treatment.|Week 4|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
835704|NCT01290679|Secondary|Percentage of Participants With On-treatment Virologic Response at All Time Points|The table below shows the percentage of participants with Hepatitis C Virus (HCV) ribonucleic acid (RNA) plasma levels below the limit of detection (ie, <25 IU/mL undetectable), the percentage of participants with a HCV RNA plasma level below the limit of quantification (ie, less than [<] 25 IU/mL detectable or undetectable), the percentage of participants with plasma levels of HCV RNA <100 IU/mL, the percentage of HCV-Infected participants with virologic responses of a greater than or equal to 2 log10 change from baseline in plasma levels of HCV RNA.|Day 3, Week 1, Week 2, Week 8, Week 16, Week 20, Week 28, Week 36, and Week 42|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
835705|NCT01290679|Secondary|Actual Values of log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)|The table below shows actual values of log10 HCV RNA levels.|Day 3, Week 1, Week 4, Week 12, Week 24, and Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||log10 IU/mL||Standard Error|Mean
835707|NCT01290679|Secondary|The Percentage of Participants Who Achieved a Sustained Virologic Response 4 Weeks After the Planned End of Treatment (SVR4)|The table below shows the percentage of participants in each treatment group who achieved a SVR4, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid levels 4 weeks after planned end of treatment.|Week 28 or Week 52|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
835708|NCT01290679|Secondary|The Percentage of Participants Who Achieved a Sustained Virologic Response 24 Weeks After the Planned End of Treatment (SVR24)|The table below shows the percentage of participants in each treatment group who achieved a SVR24, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid levels 24 weeks after planned end of treatment.|Week 48 or Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
835709|NCT01290679|Secondary|The Percentage of Participants Achieving a Sustained Virologic Response at Week 72 (SVRW72)|The table below shows the percentage of participants in each treatment group who achieved a SVRW72, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid levels at end of treatment (EOT) and at Week 72.|Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
835710|NCT01290679|Primary|The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12)|The table below shows the percentage of participants in each treatment group who achieved a SVR12, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid 12 weeks after planned end of treatment.|Week 36 or Week 60|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
835711|NCT01290718|Secondary|Progression-Free Survival|Tumor response was evaluated according to RECIST criteria (version 1.1). Progressive Disease was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Participants without progression were censored at the date of last tumor assessment when non progression was documented.|Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or Death|Data were not analyzed due to early termination of the study.|||||
835712|NCT01290718|Secondary|Overall Survival|Overall survival (OS) is the time from the date of randomization to the date of death irrespective of the cause of death.|Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or Death|Data were not analyzed due to early termination of the study.|||||
835713|NCT01290718|Secondary|Time to Disease Progression|Tumor response was evaluated according to RECIST criteria (version 1.1). Progressive Disease was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Time to progression is the time from the date of first dose of drug administration to the date when first disease progression is recorded.|Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or Death|Data were not analyzed due to early termination of the study.|||||
835714|NCT01290718|Primary|Percentage of Participants With Overall Response|The tumor response was measured according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria (Version 1.1).|Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or Death|Data were not analyzed due to early termination of the study.|||||
835715|NCT01290731|Secondary|The Number of Participants With Abnormal Alanine Aminotransferase (ALT) Levels at Baseline Who Achieved Normal ALT Levels at the End of Treatment (EOT)|The table below shows the number of participants with abnormal ALT levels at baseline (Day 1) who achieved normalization of ALT levels (defined as an ALT value less than or equal to the Upper Limit of Normality [ie, 40 IU/mL] at EOT). At baseline, 15/49 participants had abnormal ALT levels.|EOT (Week 24 or 48)|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.||Participants|||Number
835716|NCT01290731|Secondary|Area Under the Plasma Concentration-time Curve From 0 to 24 Hrs (AUC24h) for TMC435|The table below shows the median (range) AUC24h values for TMC435 for all participants who received TMC435 for up to 12 weeks. “Overall” is the median exposure estimate using all available data for each participant in the study. Sparse blood samples were collected during the study (blood sampling times were 3 and 5 hours post- dose at Week 2 and Week 8 and pre-dose and 2 hours post-dose at Week 4 and Week 12).|Overall (blood sampling times were 3 and 5 hours post- dose at Week 2 and Week 8 and pre-dose and 2 hours post-dose at Week 4 and Week 12)|Pharmacokinetic (PK) analysis was performed in the PK population defined as all participants from whom sparse blood samples were drawn and who received at least 1 dose of study medication.||ng.h/mL||Full Range|Median
835717|NCT01290731|Secondary|Plasma Concentrations of TMC435|The table below shows median (range) TMC435 predose plasma concentration (C0h) values and the TMC435 maximum plasma concentration (Cmax) values for all participants who received TMC435 for up to 12 weeks. “Overall” is the median exposure estimate using all available data for each participant in the study.Sparse blood samples were collected during the study (blood sampling times were 3 and 5 hours post- dose at Week 2 and Week 8 and pre-dose and 2 hours post-dose at Week 4 and Week 12).|Overall (blood sampling times were 3 and 5 hours post- dose at Week 2 and Week 8 and pre-dose and 2 hours post-dose at Week 4 and Week 12)|Pharmacokinetic (PK) analysis was performed in the PK population defined as all participants from whom sparse blood samples were drawn and who received at least 1 dose of study medication.||ng/mL||Full Range|Median
835730|NCT01290796|Secondary|Percentage of Patients With Impression of Improvement With Procedure at 36 Months|"Patient satisfaction was assessed using the Patient Global Impression of Improvement (PGII) questionnaire. Patients were considered to be satisfied if they felt that their urinary tract conditio0n was very much better or much better than how it felt before the surgery."|0-36 Months|Patients who completed 36 month evaulations||percentage of participants|||Number
837971|NCT01309919|Secondary|Expulsions|Incidence of spontaneous IUD expulsion in the six months after insertion|6 months|We assessed the number of expelled IUDs for all participants who had an IUD placed||participants|||Number
835718|NCT01290731|Secondary|The Number of Participants Demonstrating Viral Relapse|The table below shows the number of participants who demonstrated viral relapse, defined as undetectable Hepatitis C Virus Ribonucleic Acid (HCV RNA) at end of treatment (EOT) and detectable HCV RNA during follow-up or detectable HCV RNA at the time points of sustained virologic response (SVR) assessment . The incidence of viral relapse was calculated for participants with undetectable HCV RNA levels at EOT and with at least one follow-up HCV RNA measurement.|Up to 72 weeks|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.||Participants|||Number
835719|NCT01290731|Secondary|The Number of Participants With Viral Breakthrough|Viral breakthrough was defined as a confirmed increase of greater than 1 log10 IU/mL in plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels from the lowest level reached or a confirmed value of plasma HCV RNA of > 2.0 log10 IU/mL in particpants whose plasma HCV RNA level had previously been below 1.2 log10 IU/mL detectable or undetectable during the treatment period. The table below shows that no viral breakthrough was noted in any participants during the treatment period of the study.|Day 1 until end of treatment (EOT [Week 24 or 48])|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.||Participants|||Number
835720|NCT01290731|Secondary|The Percentage of Participants With Undetectable Plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) During Treatment and at the End of Treatment (EOT)|The table below shows the percentage of participants with undetectable HCV RNA (defined as less than 1.2 log10 IU/mL during treatment at Weeks 4, 12, 24, 36, 48, 60, 72, and at EOT [Week 24 or 48]).|Weeks 4, 12, 24, 36, 48, 60, 72, and at EOT|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.||Percentage of participants|||Number
835721|NCT01290731|Secondary|The Percentage of Participants Who Achieved a Greater Than or Equal to 2 log10 IU/mL Drop From Baseline in Plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) at Each Time Point During Treatment and Follow-up|The table below shows the percentage of participants with greater than or equal to 2 log10 IU/mL drop from baseline in plasma HCV RNA at each time point during treatment, at the end of treatment (Week 24 or 48), and post-treatment follow-up.|Days 3 and 7, Weeks 2, 3, 4, 8, 12, 16, 20, 24, 28, 36, 48, 60, 72, EOT, and follow-up (FU) Weeks 4, 12, and 24|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.||Percentage of participants|||Number
835722|NCT01290731|Secondary|The Percentage of Participants With a Sustained Virologic Response 24 Weeks After the Actual End of Treatment (SVR24)|The table below shows the percentage of participants with a SVR24 defined as participants with undetectable plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) at the end of treatment (Week 24 or 48) and at 24 weeks after the last dose of treatment (Week 48 or 72).|Week 48 or 60|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.||Percentage of participants|||Number
835723|NCT01290731|Primary|The Percentage of Participants With a Sustained Virologic Response 12 Weeks After the Actual End of Treatment (SVR12)|The table below shows the percentage of participants with an SVR12 defined as participants with undetectable plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) at the end of treatment (Week 24 or 48) who also had undetectable plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) 12 weeks after the last dose of treatment (Week 36 or 60).|Week 36 or 60|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.||Percentage of participants|||Number
835724|NCT01290757|Secondary|AUC0-∞ of Free Dabigatran.|Area under the concentration-time curve of free dabigatran in plasma over the time interval from 0 extrapolated to infinity. Adjusted for treatment, period and sequence (all fixed effects), and random subject effect.|60 hours|PKS||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
835725|NCT01290757|Secondary|Cmax of Free Dabigatran in Plasma.|Adjusted for treatment, period and sequence (all fixed effects), and random subject effect.|60 hours|PKS||ng/mL||Geometric Coefficient of Variation|Geometric Mean
835726|NCT01290757|Secondary|AUC0-tz of Free Dabigatran.|Area under the concentration-time curve of free dabigatran in plasma from time 0 to the time of the last quantifiable data point. Adjusted for treatment, period and sequence (all fixed effects), and random subject effect.|60 hours|PKS||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
835727|NCT01290757|Secondary|Area Under the Curve 0 to Infinity (AUC0-∞) of Total Dabigatran.|Area under the concentration-time curve of total dabigatran in plasma over the time interval from 0 extrapolated to infinity. Adjusted for treatment, period and sequence (all fixed effects), and random subject effect.|60 hours|PKS||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
835728|NCT01290757|Primary|Maximum Measured Concentration (Cmax) of Total Dabigatran in Plasma|Adjusted for treatment, period and sequence (all fixed effects), and random subject effect.|60 hours|PKS||ng/mL||Geometric Coefficient of Variation|Geometric Mean
835729|NCT01290757|Primary|Area Under the Curve 0 to tz (AUC0-tz) of Total Dabigatran|Area under the concentration-time curve of total dabigatran in plasma from time 0 to the time of the last quantifiable data point, adjusted for treatment, period and sequence (all fixed effects), and random subject effect.|60 hours|This subject set, the pharmacokinetic set (PKS), includes all subjects of the treated set who provide at least one evaluable observation for at least one of the three PK endpoints of total dabigatran, which is obtained in a period without important protocol violations relevant to the evaluation of bioequivalence.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
836256|NCT01286740|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 (FDA Snapshot Analysis)|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the FDA snapshot analysis.|Week 24|Full Analysis Set||percentage of participants|||Number
835731|NCT01290796|Secondary|Percentage of Patients With Impression of Improvement With Procedure at 12 Months|"Patient satisfaction was assessed using the Patient Global Impression of Improvement (PGII) questionnaire. Patients were considered to be satisfied if they felt that their urinary tract condition was very much better or much better than how it felt before the surgery."|0-12 Months|Patients who completed 12 month evaulations||percentage of participants|||Number
835732|NCT01290796|Secondary|Change in Incontinent Impact Questionnaire at 36 Months|Mean change in overall IIQ-7 summary score (range 0 - 100). Scores on the IIQ-7 range from 0 (best outcome) to 100 (worst outcome). For this outcome measure, IIQ-7 at baseline was compared to that administered at 36-months post-surgery.|0-36 months|||units on a scale||Standard Deviation|Mean
835733|NCT01290796|Secondary|Change in Incontinent Impact Questionnaire at 12 Months|Mean change in overall IIQ-7 summary score (range 0 - 100). Scores on the IIQ-7 range from 0 (best outcome) to 100 (worst outcome). For this outcome measure, IIQ-7 at baseline was compared to that administered at 12-months post-surgery.|0-12 months|||units on a scale||Standard Deviation|Mean
835734|NCT01290796|Secondary|Percentage of Subjects Who Showed Improvement in Self-reported SUI Symptoms at 36 Months|Improvement was defined as a 25-point decrease (improvement) in Urinary Distress Inventory (UDI-6) score (Range: 0 - 100).|0-36 Months|||percentage of participants||95% Confidence Interval|Number
835735|NCT01290796|Secondary|Change in Post-operative Pain|"Mean change in Overall McCarthy Surgical Pain Scale from Day 0 to Day 7. McCarthy Pain Scale is a 50 millimeter line with No Pain Sensation noted at the 0 mm mark and Most Intense Pain Imaginable noted at the 50 mm mark. Each day, subjects are asked to mark their level of pain somewhere along the line. Change in pain level is reported in millimeters."|0-7 days|||millimeters||Standard Deviation|Mean
835736|NCT01290796|Secondary|Operative, Perioperative and Long-term Complications Through 36 Months|Percentage of Patients with Procedure and/or Device Related Adverse Events through 36 months|Day 15 through 36-months post procedure|||percentage of participants||95% Confidence Interval|Number
835737|NCT01290796|Secondary|Operative, Perioperative and Long-Term Complications Perioperatively|Percentage of Patients with Procedure and/or Device Related Adverse Events Perioperatively|1-15 days|||percentage of participants||95% Confidence Interval|Number
835738|NCT01290796|Secondary|Operative, Perioperative and Long-Term Complications During Operative Procedure|Percentage of Patients with Procedure and/or Device Related Adverse Events During the Operative Procedure|1 day|||percentage of participants||95% Confidence Interval|Number
835739|NCT01290796|Primary|Percentage of Subjects Who Showed Improvement in Self-reported SUI Symptoms at 12 Months|Improvement was defined as a 25-point decrease (improvement) in Urinary Distress Inventory (UDI-6) score (Range: 0 - 100).|12-months post procedure|||percentage of participants||95% Confidence Interval|Number
835740|NCT01290796|Primary|Percentage of Patients Free of Stress Urinary Incontinence|Percentage of patients who are free of stress urinary incontinence, as assessed by a negative (-) Cough Stress Test (CST) and no surgical retreatment, at the 12 month study visit.|12-months post surgical procedure|||percentage of participants||95% Confidence Interval|Number
835741|NCT01290822|Secondary|Interventricular Synchrony||13 minutes of testing; performed before CPB for allograft receipt|Results could not be analyzed due to poor enrollment and lack of data.|||||
835742|NCT01290822|Secondary|Peak RV dP/dt||13 minutes of testing; performed before CPB for allograft receipt|Results could not be analyzed due to poor enrollment and lack of data.|||||
835743|NCT01290822|Secondary|Peak LV dP/dt||13 minutes of testing; performed before CPB for allograft receipt|Results could not be analyzed due to poor enrollment and lack of data.|||||
835744|NCT01290822|Secondary|Interatrial Delay (Between Right Atrium and Left Atrium)|Results could not be analyzed due to poor enrollment and lack of data.|13 minutes of testing; performed before CPB for allograft receipt||||||
835745|NCT01290822|Secondary|Atrial Latency||13 minutes of testing; performed before CPB for allograft receipt|Results could not be analyzed due to poor enrollment and lack of data.|||||
835746|NCT01290822|Primary|Cardiac Output|The primary endpoint of this study compares cardiac output between AAI pacing and optimal BiVP for DCM and ICM groups separately.|13 minutes of testing; performed before CPB for allograft receipt|Results could not be analyzed due to poor enrollment and lack of data.|||||
835747|NCT01290887|Secondary|Participants With a Positive Anti-Reslizumab Antibody Status at Baseline, Weeks 24, 48, 72, 96, End of Study, Endpoint and Overall|"Blood samples were collected for the determination of anti-drug antibody (ADAs) before study drug infusion at baseline and every 24 weeks until end of treatment visit or early withdrawal. Serum samples were analyzed by Teva (Teva Biopharmaceuticals USA, Rockville, Maryland, USA) using a validated homogeneous solution based bridging enzyme linked immune sorbent assay (Mikulsis et al 2011, Qui et al 2010). The analysis of anti-reslizumab antibody in patient serum consists of 3 tiers of assays for screening, confirmation, and titer analysis. If a participant had a treatment-emergent ADA response (ie, ADA positive at any of the postdose time points but negative at the predose time point) or if there was a treatment-boosted ADA response (defined as a greater than 4-fold increase from a positive baseline ADA response (Shankar et at 2014), the participant was classified as overall ADA positive.
Predose samples for the reslizumab-experienced participants came from the previous studies."|Baseline, Weeks 24, 48, 72, 96, End of Study, Endpoint and Overall|Safety analysis set of participants with assessments at stated timeframes||participants|||Number
835748|NCT01290887|Secondary|Asthma Quality of Life Questionnaire (AQLQ) Total Score at Weeks 24, 48, 72, 96, End of Study and Endpoint|"The AQLQ is a 32-item instrument administered as a self-assessment (Juniper et al 1992). The questionnaire is divided into 4 domains: activity limitation, symptoms, emotional function, and environmental stimuli. Patients were asked to recall their experiences during the last 2 weeks and to respond to each question on a 7-point scale (1=severe impairment, 7=no impairment). The overall AQLQ score is the mean of all 32 responses. Five of the activity questions were patient-specific, which means that each patient identified and scored 5 activities in which the patient was limited by asthma; these 5 activities were identified at the first visit and retained for all subsequent follow-up visits."|Weeks 24, 48, 72, 96, End of Study and Endpoint|Safety analysis set of participants with assessments at stated timeframes||units on a scale||Standard Deviation|Mean
835759|NCT01290913|Secondary|Number of Participants That Tolerated Rapid Oral Peanut Desensitization to a Dose of 4,000 mg of Peanut Flour.|To tolerate refers to the ability of the patient to ingest the final challenge of 4000mg peanut flour, with either no or mild symptoms.|after 7-8 wks of desensitization|||participants|||Number
835749|NCT01290887|Secondary|Asthma Control Questionnaire (ACQ) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint|The ACQ is a 7-item instrument that measures asthma control (Juniper et al 1999). Six questions are self-assessments; the seventh item, completed by a member of the study staff, is the result of the patient's FEV1 measurement. Each item has 7 possible answers on a scale of 0 to 6, and the total score is the mean of all responses (the total scale is therefore 0-6). A higher score is an indication of poorer asthma control.|Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, end of study and endpoint|Safety analysis set of participants with assessments at stated timeframes||units on a scale||Standard Deviation|Mean
835750|NCT01290887|Secondary|Asthma Symptom Utility Index (ASUI) Score at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint|The ASUI is an 11-item instrument designed to assess the frequency and severity of asthma symptoms and side effects, weighted by patient preferences (Revicki et al 1998). ASUI is a utility score that ranges from 0 to 1, with higher values indicating better asthma control.|Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, end of study and endpoint|Safety analysis set of participants with assessments at stated timeframes||units on a scale||Standard Deviation|Mean
835751|NCT01290887|Primary|Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Vital Signs Values|"Data represents participants with PCS vital sign values during any of the during treatment visits or the follow-up visit.
Significance criteria
Sitting heart rate-high: >100 and increase of >= 30 beats/min (all ages)
Sitting heart rate-low: <50 and decrease of >=30 beats/min
Sitting systolic blood pressure (BP)-high: >130 and increase of >=30 mmHg (ages 12-17)
Systolic BP-low: <90 and decrease of >=30 mmHg (ages >=18)
Systolic BP-high: >160 and increase of >=30 mmHg (ages >=18)
Sitting diastolic BP-low: <55 and decrease of >=12 mmHg (ages 12-17)
Diastolic BP-high: >85 and increase of >=12 mmHg (ages 12-17)
Diastolic BP-low: <50 and decrease of >=12 mmHg (ages >=18)
Diastolic BP-high: >100 and increase of >=12 mmHg (ages >=18)
Respiration rate: >20 and increase of >=10 breaths/minute (ages 12-17)
Respiration rate: >24 and increase of >=10 breaths/minute (ages >=18)
Body temperature-low: <96.5° Fahrenheit (all ages)
Body temp-high: >100.5° F (all ages)"|Week 4 to Week 65|Safety analysis set, including participants who contributed to the analysis||participants|||Number
835752|NCT01290887|Secondary|Average Daily Use of Short-Acting Beta-Agonist (SABA)Therapy at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint|SABA are used for quick relief of asthma symptoms. To measure SABA use, at each clinical visit participants were asked to recall their usage of SABA therapy within the last 3 days of the scheduled visit. If usage was confirmed, the number of puffs used was recorded. For the purpose of summaries, an average daily usage was evaluated by dividing the total number of puffs recorded over 3 days by 3.|Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, end of study and endpoint|Safety analysis set of participants with assessments at stated timeframes||# puffs/day||Standard Deviation|Mean
835753|NCT01290887|Secondary|Forced Expiratory Flow at 25% to 75% Forced Vital Capacity (FEF 25%-75%) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint|The FEF 25%-75% is the force expiratory flow at 25% to 75% of the Forced Vital Capacity (FVC), measured in liters/second|Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, end of study and endpoint|Safety analysis set of participants with assessments at stated timeframes||liters/second||Standard Deviation|Mean
835754|NCT01290887|Secondary|Forced Vital Capacity (FVC) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint|The FVC is the volume of air that can be forcibly blown out after full inspiration, measured in liters.|Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, end of study and endpoint|Safety analysis set of participants with assessments at stated timeframes||liters||Standard Deviation|Mean
835755|NCT01290887|Secondary|Percent Predicted Forced Expiratory Volume In 1 Second (% Predicted FEV1) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint|The percent predicted FEV1 is the ratio of the volume of air expired in the first second of a forced expiration to the patient's predicted FEV based on a similar population without asthma. Percent predicted lung function values were transcribed directly from the lung function report to the CRF, without any calculation by Teva.|Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, end of study and endpoint|Safety analysis set of participants with assessments at stated timeframes||percentage of predicted FEV1||Standard Deviation|Mean
835756|NCT01290887|Secondary|Forced Expiratory Volume In 1 Second (FEV1) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint|FEV1 is a standard measurement of air movement in the lungs of patients with asthma obtained from pulmonary function tests. It is the volume of air expired in the first second of a forced expiration using a spirometer.|Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, end of study and endpoint|Safety analysis set of participants with assessments at stated timeframes||liters||Standard Deviation|Mean
835757|NCT01290887|Primary|Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Abnormal Lab Values|"Data represents participants with potentially clinically significant (PCS) abnormal serum chemistry, hematology, and urinalysis values on any of the during treatment lab analyses.
Significance criteria:
Blood urea nitrogen: >=10.71 mmol/L
Creatinine: >=177 μmol/L
Uric acid: M>=625, F>=506 μmol/L
Aspartate aminotransferase: >=3*upper limit of normal (ULN). Normal range is 10-43 U/L
Alanine aminotransferase: >=3*ULN. Normal range is 10-40 U/L
GGT = gamma-glutamyl transpeptidase: >= 3*upper limit of normal. Normal range is 5-49 U/L.
Total bilirubin: >=34.2 μmol/L
White blood cells- low: <=3.0*10^9/L
White blood cells-high: >=20*10^9/L
Hemoglobin: M<=115, F<=95 g/dL
Hematocrit: M<0.37, F<0.32 L/L
Platelets: >=700*10^9/L
Absolute neutrophil count: <=1.0*10^9/L
Eosinophils: >=10
Urinalysis: ketones, blood, glucose, and total protein: >=2 unit increase from baseline"|Weeks 4, 8, 24 and 48|Safety analysis set, including participants who contributed to the analysis||participants|||Number
835758|NCT01290887|Primary|Participants With Treatment-Emergent Adverse Events|An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an inability to carry out usual activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.|Safety analysis set||participants|||Number
835760|NCT01290913|Primary|Number of Participants That Tolerated Rapid Oral Peanut Desensitization to a Dose of 500 mg Peanut Flour (Cumulative Dose, 1,000 mg)|To tolerate refers to the ability of the patient to ingest the challenge dose of 500 mg peanut flour (1000 mg cumulatively) with either no or mild symptoms.|First day of desensitization|||participants|||Number
835761|NCT01290952|Secondary|Number of Patients With Secondary Combined Endpoint (i.e. With One or More of the Following)|"Number of patients with one of more of the following:
Post-operative Atrial Fibrillation
IAPB (Intra-Aortic Balloon Pump) insertion and low cardiac output syndrome
Ventilation > 24h
Sternal wound infection or dehiscence"|30 days|||participants|||Number
835762|NCT01290952|Primary|Number of Patients With Post-operative Combined Endpoint (i.e. With One or More of the Following)|"Number of patients with one or more of the following:
Operative Mortality
Myocardial Infarction
Postoperative neurological complications
Renal failure
ARDS (Acute Respiratory Distress Syndrome)
Bleeding"|30 days|||participants|||Number
835763|NCT01290978|Secondary|Skin Assessment on Ioban, ActiGard, Steri-Drape 2 Application Sites Respectively|Visual assessment on skin after samples were removed. scale: 0 (no skin reaction), 4 (severe skin reaction)|30 minutes|The number of participants was determined to provide 80% power to detect a difference of 20% for the drape by prep comparisons||units on a scale||Standard Deviation|Mean
835764|NCT01290978|Primary|Drape Adhesion|The peel force to remove the sample|30 minutes|Data analysis per protocol||grams-force||95% Confidence Interval|Mean
835765|NCT01291017|Secondary|Grade of Study Drug Toxicity|The number of all toxicities and grades 3 and 4 (per CTCAE v3.0) toxicities that occured during the administration of the drug and during the follow up period.|24 months|||Events|||Number
835766|NCT01291017|Secondary|Plasma Levels|Plasma levels of p16, phosphorylated RB and cyclin d1 in blood.|6 months|4 of the 16 samples were tested by protein immunoblot (Western blot), and due to the test not being sensitive enough to detect p16, phosphorylated RB or cyclin D1 protein bands in any of the samples, the decision was made not to purse this testing any further.||Arbitrary Units|||Number
835767|NCT01291017|Secondary|Progression-free Survival|Median progression-free survival.|12 months|||Weeks||Standard Error|Median
835768|NCT01291017|Secondary|Overall Survival|Median overall survival|14 months|||weeks||Standard Error|Median
835769|NCT01291017|Primary|Tumor Response by Direct RECIST Measurement|Response is a decrease in the sum of the longest diameters of the target lesions by more than 30% compared to the baseline.|6 months|||participants|||Number
835770|NCT01291056|Primary|Luteal Cycle Total Physical Score for Calendar of Premenstrual Experiences (COPE) Self Assessment|To identify physical symptoms experienced by women taking clomiphene citrate versus placebo for superovulation in a prospective setting.|1 year|The scale incorporates physical, behavioral and mental symptoms. Each participant will rate the symptom(s) from zero to three based off severity. Symptoms with zero means that no symptoms are present. Symptoms with three means that the symptoms are severe. Physical symptoms were calculated to give the total score. Range 0 -75 per cycle day.||units on a scale||Full Range|Median
835771|NCT01291056|Primary|Luteal Cycle Total Behavioral Score for Calendar of Premenstrual Experiences (COPE) Self Assessment|To identify behavioral symptoms experienced by women taking clomiphene citrate versus placebo for superovulation in a prospective setting.|1 year|The scale incorporates physical, behavioral and mental symptoms. Each participant will rate the symptom(s) from zero to three based off severity. Symptoms with zero means that no symptoms are present. Symptoms with three means that the symptoms are severe. Range 0 -75 per cycle day.||units on a scale||Full Range|Median
835772|NCT01291056|Primary|Follicular Cycle Total Physical Score for Calendar of Premenstrual Experiences (COPE) Self Assessment|To identify physical symptoms experienced by women taking clomiphene citrate versus placebo for superovulation in a prospective setting.|1 Year|The scale incorporates physical, behavioral and mental symptoms. Each participant will rate the symptom(s) from zero to three based off severity. Symptoms with zero means that no symptoms are present. Symptoms with three means that the symptoms are severe. Range 0 -75 per cycle day.||units on a scale||Full Range|Median
835773|NCT01291056|Primary|Follicular Cycle Total Behavioral Score for Calendar of Premenstrual Experiences (COPE) Self Assessment|To identify behavioral symptoms experienced by women taking clomiphene citrate versus placebo for superovulation in a prospective setting.|1 year|The scale incorporates physical, behavioral and mental symptoms. Each participant will rate the symptom(s) from zero to three based off severity. Symptoms with zero means that no symptoms are present. Symptoms with three means that the symptoms are severe. Range 0 -75 per cycle day.||units on a scale||Full Range|Median
835774|NCT01291108|Secondary|Change From Baseline in Worse Eye IOP|IOP is a measurement of the fluid pressure inside the eye. The worse eye IOP refers to eye with the worse baseline IOP, which is determined as the eye with the higher mean diurnal IOP at baseline. If both eyes have the same mean diurnal IOP at baseline, the right eye is designated as the worse eye. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening). Data are recorded at Hours 0, 4, 8, and 12.|Baseline, Day 57|Modified Intent to Treat: all randomized and treated patients who had a baseline and at least 1 post-baseline IOP measurement||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
835775|NCT01291108|Primary|Change From Baseline in Average Eye IOP|IOP is a measurement of the fluid pressure inside the eye. The average of the 2 eyes are used for the analyses. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening). Data are recorded at Hours 0, 4, 8, and 12.|Baseline, Day 57|Modified Intent to Treat: all randomized and treated patients who had a baseline and at least 1 post-baseline IOP measurement||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
835776|NCT01291160|Primary|Number of 100% Wound Closure||before or at week 12|Analyzed the per-protocol population||percentage of patients|||Number
835777|NCT01291173|Secondary|Change From Baseline in Short Form-12 Health Survey (SF-12) Score at Week 11|The SF-12 is a 12-item self-report questionnaire that is a subset of the SF-36 Health Survey. The survey captures physical and mental health. There are 8 subscales. Four of the subscales has one-item each; the other 4 have two-items each. For each subscale, a mean value was first computed and transformed to a position on a scale ranging from 0-100 (Z-transformation). The aggregate total scores are then transformed into a mean value ranging from 0 (lowest level of health) to 100 (highest level of health).|Baseline and week 11|Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
835778|NCT01291173|Secondary|Change From Baseline in Barratt Impulsiveness Scale (BIS-11) Total Score at Week 11|The BIS-11 is a self-reported 30-item questionnaire that measures impulsiveness using a 4-point Likert scale (rarely/never = 1, occasionally = 2, often = 3, almost always/always = 4). A Total Impulsivity score is calculated by summing the scores for each item. Possible scores range from 30 – 120. Higher scores indicate increased impulsiveness.|Baseline and week 11|Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
835779|NCT01291173|Secondary|Change From Baseline in Binge Eating Scale (BES) Score at Week 11|The BES is a 16-item self-reported questionnaire that is designed to assess behavioral, affective, and attitudinal components of the subjective experience of binge eating. The items are summed, with possible scores ranging from 0 to 46. A score of 27 or higher indicates severe binge-eating problems, and a score of 17 or lower designates no binge-eating problems.|Baseline and week 11|Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
835780|NCT01291173|Secondary|Change From Baseline in Eating Inventory Score at Week 11|The Eating Inventory also known as the Three-Factor Eating Questionnaire is a 51-item self-reported questionnaire intended to assess 3 dimensions of eating behavior: cognitive restraint of eating, disinhibition, and hunger. Cognitive restraint of eating consists of 20 items, disinhibition consists of 16 items, and hunger consists of 15 items. Each item scores either 0 or 1 point for a total score of 0-20 for cognitive restraint of eating, 0-16 for disinhibition, and 0-15 for hunger. A higher score is better for cognitive restraint of eating and lower scores are better for disinhibition and hunger.|Baseline and week 11|Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
835781|NCT01291173|Secondary|Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Score at Week 11|The HAM-A is a rating scale developed to quantify the severity of anxiety symptomatology. It consists of 14 items, each defined by a series of symptoms. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe) with a total score range of 0–56, where <17 indicates mild severity, 18–24 mild to moderate severity, and 25-30 moderate to severe, and 31-56 severe anxiety.|Baseline and week 11|Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
835782|NCT01291173|Secondary|Change From Baseline in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Score at Week 11|MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression.|Baseline and week 11|Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
835783|NCT01291173|Secondary|Change From Baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (YBOCS-BE) Total Score at Week 11|The YBOCS-BE measures the obsession of binge-eating thoughts and compulsiveness of binge-eating behaviors. The scale is a clinician-rated, 10-item scale, each item rated from 0 (no symptoms) to 4 (extreme symptoms). Total scores range from 0 to 40. A score of 0-7 is sub-clinical; 8-15 is mild; 16-23 is moderate; 24-31 is severe; and 32-40 is extreme.|Baseline and week 11|Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
835784|NCT01291173|Secondary|Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) at Up to 11 Weeks|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|Up to 11 weeks|Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment. (Not all subjects in the FAS had an assessment for this outcome.)||Percentage of participants|||Number
835785|NCT01291173|Secondary|Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Up to 11 Weeks|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|up to 11 weeks|Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment. (Not all subjects in the FAS had an assessment for this outcome.)||Percentage of participants|||Number
835786|NCT01291173|Secondary|Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|Baseline|Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment. (Not all subjects in the FAS had an assessment for this outcome.)||Percentage of participants|||Number
835787|NCT01291173|Secondary|4-Week Binge Response|Subjects are free from binge episodes for 4 weeks.|Last 28 days on study|Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment.||Participants|||Number
835788|NCT01291173|Secondary|1-Week Binge Response, Last Observation Carried Forward (LOCF)|The 1-week binge response was defined as either a 1-week remission (a 100% reduction of binge episodes from baseline [ie, a cessation of binge eating behavior]), or a marked response (75 to <100% reduction in binge episodes from baseline), or a moderate response (50 to <75% reduction in binge episodes from baseline), or a negative/minimal response (<50% reduction in binge episodes from baseline). The 1-week response was determined at the end of the study utilizing a LOCF approach.|Last 7 days on study|Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment.||Participants|||Number
835789|NCT01291173|Secondary|Change From Baseline in the Number of Binge Episodes Per Week at Up to 11 Weeks|The number of binge episodes per week as assessed by clinical interview based on subject diary.|Baseline and up to 11 weeks|Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment.||Binge Episodes||Standard Deviation|Mean
835790|NCT01291173|Primary|Change From Baseline in Log Transformed Binge Days Per Week at Week 11|Binge day is defined as a day during which at least 1 binge episode occurs.|Baseline and week 11|Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment.||Log days||Standard Error|Least Squares Mean
835791|NCT01291225|Secondary|Playground and Farm Safety Knowledge, Attitudes and Practices Composite Scores|The investigators hypothesize that the improvement in the playground safety Knowledge, Attitudes, and Practices (KAP) survey composite scores and farm audits from the baseline in year 1 to the follow-up in year 3 will be significantly greater for parents residing in Ross County than for parents in the non-intervention counties (Morrow and Pickaway).The playground safety KAP survey consisted of 7 items and individuals could receive a summed score of 0-7, with a score of 7 indicating mastery of the material.|Year 1 baseline to Year 3 follow-up|||composite score||Standard Deviation|Mean
835792|NCT01291225|Primary|Change in Playground Hazards|The investigators hypothesize that the decrease in the number of identified playground hazards (comparing each playground to itself from the year 1 baseline survey to the year 3 follow-up survey utilizing a playground hazards checklist) will be significantly greater for the intervention playgrounds compared with non-intervention playgrounds in Circleville, Pickaway Co. The percentage increase in the number of playgrounds with adequate safety surfacing will be used as a proxy for playground hazardousness.|Year 1 baseline to year 3 follow-up|||% increase playgrounds w/surfacing|||Number
835793|NCT01291264|Primary|Subject's Infected-status as Determined by the Nucleic Acid Amplification Assays Performed.|This is a single-point prevalence assessment done when subjects present at the STD clinic for routine STD screening. Subjects are not followed beyond the clinic visit.|1 day - (At clinic visit)|per protocol||Positive test result|||Number
835794|NCT01291277|Primary|Proportion of Patients With Eradication of Esophageal Varices||At 4 weeks|||Participants|||Count of Participants
835795|NCT01291498|Secondary|Voice Morbidity|Voice Handicap Index. 30 questions rated on a five point scale from 'never' to 'always' and an overall score from 1 'normal' to 10 'severely impaired'|Up to one year post-treatment|||units on a scale|||Number
835796|NCT01291498|Secondary|Eucalcaemia|Ca in plasma|Six weeks post-treatment.Six month data were also intended to be reported, however, six month data were not analyzed because only one subject was entered and this subject was withdrawn from the study before six months after treatment.|Six month data were also intended to be reported, however, six month data were not analyzed because only one subject was entered and this subject was withdrawn from the study before six months after treatment.||mmol/L|||Number
835797|NCT01291498|Primary|Eucalcaemia|Calcium in the blood is measured from venepuncture|12 months post-treatment|The primary endpoint was not analysed because only one subject was entered and this subject was withdrawn from the study before 12 months after treatment.|||||
835798|NCT01291784|Secondary|JAK2V617F Allele Burden|Investigate exploratory markers, hematopoietic cells, for their ability to predict responsiveness to treatment with GC1008. Analysis of percentage of mutant alleles in hematopoietic stem cells.|6 months|||percentage of mutant alleles|||Number
835799|NCT01291784|Secondary|Peripheral Blood CD34+|Investigate exploratory markers for their ability to predict responsiveness to treatment with GC1008.|6 months|||percentage of hematopoietic stem cells|||Number
835800|NCT01291784|Secondary|European Consensus Fibrosis Grade|"To assess the clinical response to therapy with GC1008 by International Working Group (IWG) criteria and measure the change in degree of bone marrow fibrosis (BMF) assessed by European consensus grading system.
This scheme consists of a qualitative (reticulin or collagen) and quantitative evaluation of bone marrow fibrosis and distinguishes four increasing categories, ranging from MF-0, which corresponds to normal bone marrow, to MF-3, in which coarse bundles of collagen fibrosis are identifiable with significant osteosclerosis."|6 months|||units on a scale|||Number
835801|NCT01291784|Secondary|Bauermeister Scale|"To assess the clinical response to therapy with GC1008 by International Working Group (IWG) criteria and measure the change in degree of bone marrow fibrosis (BMF) assessed by Bauermeister scale.
Bauermeister scale: 0, no demonstrable reticulin fibers; 1, occasional fine individual fibers and foci of a fine-fiber network; 2, fine fiber network throughout most of the section, but no coarse fibers; 3, diffuse fiber network with scattered thick coarse fibers, but no mature collagen; and 4, diffuse, often coarse fiber network with areas of collagen."|6 months|||units on a scale|||Number
835802|NCT01291784|Primary|Safety and Tolerability|"To assess the safety and tolerability of GC1008 in patients with primary myelofibrosis (PMF) or post-polycythemia vera/essential thrombocythemia myelofibrosis (Post-PV/ET MF).
A total of 9 AEs determined by the investigator to be at least possibly related to GC1008 occurred during the study."|28 days|||events|||Number
835803|NCT01292005|Secondary|Number of Subjects Who Needed an Intensive Care Unit Stay||30 days, or until dismissal, whichever came first|||participants|||Number
835804|NCT01292005|Secondary|Length of Intensive Care Unit (ICU) Stay||30 days or until dismissal date, whichever occurs earlier|||Days||Full Range|Median
835805|NCT01292005|Secondary|Length of Hospital Stay||30 days or until dismissal date, whichever occurs earlier|||days||Full Range|Median
835806|NCT01292005|Secondary|Number of Patients With Lengthy Hospital Stays|"Lengthy was defined as either greater than 4 days or greater than 10 days."|30 days or until dismissal date, whichever occurs earlier|||participants|||Number
835807|NCT01292005|Secondary|Number Of Subjects With New Onset Pancreatic Necrosis During Hospitalization||1 week or until dismissal date whichever occurs earlier|||participants|||Number
835808|NCT01292005|Secondary|Number Of Subjects With New Onset Organ Failure During Hospitalization||1 week or until dismissal date whichever occurs earlier.|||participants|||Number
835809|NCT01292005|Primary|Changes in Interleukin (IL) IL-8|Normal value range for IL-8 = 0 - 5 pg/ml.|baseline, Day 1, Day 3|||pg/ml||Full Range|Median
835810|NCT01292005|Primary|Change in Interleukin (IL) IL-6|Normal value range for IL-6 = 0 - 5 pg/ml.|baseline, Day 1, Day 3|||pg/ml||Full Range|Median
835811|NCT01292005|Primary|Change in Tumor Necrosis Factor (TNF)-Alpha|Normal value range for TNF alpha = 0 - 22 pg/ml.|baseline, Day 1, Day 3|||pg/ml||Full Range|Median
835812|NCT01292005|Primary|Change in C-Reactive Protein (CRP)|C-reactive protein is produced by the liver. The level of CRP rises when there is inflammation throughout the body. The normal value range for CRP = 1-10 mg/L.|baseline, Day 1, Day 3|||mg/L||Full Range|Median
835813|NCT01292057|Primary|Total Number of Drinks Consumed in Bar Lab|"This measure refers to a bar lab paradigm in which individuals received an initial priming drink of alcohol, targeted to produce a breath alcohol concentration (BrAC) of 30 mg%, and could then choose to consume up to 8 additional drinks, each targeted to produce a BrAC of 15 mg%, during the subsequent 2 hours. Thus, the total number of drinks consumed could range between 0 and 8."|2 hours during the bar lab paradigm|||bar lab drinks||Standard Error|Mean
835814|NCT01292057|Primary|Total Number of Drinks Per Day During Natural (Usual Environment) Conditions|"Natural alcohol consumption period -- drinks per day consumed during the 6-day observation period"|6-day observation period|||standard drinks||Standard Error|Mean
835815|NCT01292070|Primary|Difference in the Doses of GFD and CAT Required to Elicit a Cutaneous Reaction Demonstrated by a Wheal Greater Than or Equal to 10 mm With Surrounding Erythema|Difference in the doses of human Fcgamma1-Fel d1 (cat allergen) fusion protein (GFD) and standardized cat hair allergenic extract (CAT) required to elicit a wheal ≥ 10 mm with surrounding erythema.|up to 3 hours after the last injection of GFD|The experimental protein (human Fcgamma1-Fel d1 fusion protein (GFD)) and the control protein (standardized cat hair allergenic extract (CAT)) elicited comparable reactivity in the first four participants dosed; thus, the trial was discontinued for futility and the primary endpoint was not evaluated|||||
835816|NCT01292135|Secondary|Progression Free Survival Rate at 12 Months|Criteria for progression are as outlined in the IWCLL 2008 criteria (Hallek 2008) and as assessed by investigator, e.g. progression defined as a 50% increase in lymph node size.|From first dose of any study medication to 12 months after first dose to progressive disease or death or the last clinical assessment before receiving new anticancer therapy or loss to follow-up, whichever occured the earliest.|||Percentage of Participants||95% Confidence Interval|Number
835817|NCT01292135|Secondary|Sustained Hematologic Improvement in Subjects With Neutropenia, Anemia, or Thrombocytopenia at Baseline||From first response assessment to last response assessment. Participants were followed with a median follow-up time of 15.8 months.|No participants in the FCR group had neutropenia, anemia or thrombocytopenia at baseline.||Percentage of Participants||95% Confidence Interval|Number
835818|NCT01292135|Secondary|Overall Response Rate (Complete Response [CR] + Complete Response With Incomplete Marrow Recovery [CRi] + Nodular Partial Response [nPR] + Partial Response [PR])|Response criteria are as outlined in the IWCLL 2008 criteria (Hallek 2008) and as assessed by investigator, e.g. response requires 50% reduction in lymph node size. Assessment of response to treatment will be done every 2 cycles for the first 6 months and then every 3 months thereafter until disease progression or prior to the administration of a new anticancer therapy and at follow-up visits.|From first response assessment to last response assessment. Participants were followed with a median follow-up time of 15.8 months.|||Percentage of Participants||95% Confidence Interval|Number
835819|NCT01292135|Secondary|Overall Incidence of Serious Adverse Events (SAEs)||From First day of dose to 30 days after last dose of any study medication. Participants were followed with a median follow-up time of 15.8 months.|||Percentage of Participants|||Number
835820|NCT01292135|Secondary|Overall Incidence of Grade ≥3 Adverse Events (AEs) Per NCI CTCAE V4.0||From First day of dose to 30 days after last dose of any study medication. Participants were followed with a median follow-up time of 15.8 months.|||Percentage of Participants|||Number
835821|NCT01292135|Secondary|Incidence of Adverse Events Requiring Dose Delay or Discontinuation of Ibrutinib||From First day of dose to 30 days after last dose of any study medication. Participants were followed with a median follow-up time of 15.8 months.|||Percentage of Participants|||Number
835822|NCT01292135|Primary|Incidence of Prolonged Hematologic Toxicity Started in Cycle 1||From First day of dose to 30 days after last dose of any study medication. Participants were followed with a median follow-up time of 15.8 months.|The FCR arm was discontinued due to very limited use of this chemo regimen in this setting, statistical analysis were limited due to the small numbers of subjects in this treatment arm.||Percentage of Participants||95% Confidence Interval|Number
835823|NCT01292187|Secondary|Percentage Change From Baseline to Week 54 of Plasma CTx-1 Following rsCT Compared to Placebo.||Baseline, Week 54|MITT population||percent change||95% Confidence Interval|Least Squares Mean
835824|NCT01292187|Primary|Percentage Change From Baseline to Week 54 of Lumbar Spine Bone Mineral Density of Active Compared to Placebo.||Baseline, Week 54|MITT population||percent change||95% Confidence Interval|Least Squares Mean
835825|NCT01292226|Secondary|Spearman's Rank Correlation Coefficient Between MPA Levels and Risk of Gastrointestinal Toxicity|The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|BL and Weeks 2, 4, 12, and 24|ITT population; n=number of samples||correlation coefficient|Participants||Number
835826|NCT01292226|Secondary|Spearman's Rank Correlation Coefficient Between MPA Levels and Risk of Hematologic Toxicity|The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|BL and Weeks 2, 4, 12, and 24|ITT population; n=number of samples||correlation coefficient|Participants||Number
835827|NCT01292226|Secondary|Spearman's Rank Correlation Coefficient Between MPA Levels and Risk of Infection|The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|BL and Weeks 2, 4, 12, and 24|ITT population; n=number of samples||correlation coefficient|Participants||Number
835828|NCT01292226|Secondary|Spearman's Rank Correlation Coefficient Between IMPDH Expression and Risk of Gastrointestinal Toxicity|The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|BL and Weeks 2, 4, 12, and 24|ITT population||correlation coefficient|Participants||Number
835829|NCT01292226|Secondary|Spearman's Rank Correlation Coefficient Between IMPDH Expression and Risk of Hematologic Toxicity|The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|BL and Weeks 2, 4, 12, and 24|ITT population||correlation coefficient|Participants||Number
835830|NCT01292226|Secondary|Spearman's Rank Correlation Coefficient Between IMPDH Expression and Risk of Infection|The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|BL and Weeks 2, 4, 12, and 24|ITT population; n=number of samples analyzed.||correlation coefficient|Participants||Number
835831|NCT01292226|Secondary|Spearman's Rank Correlation Coefficient Between IMPDH Inhibition and Risk of Acute Rejection|The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|BL and Weeks 2, 4, 12, and 24|ITT population; n=number of samples analyzed.||correlation coefficient|Participants||Number
835832|NCT01292226|Secondary|Spearman's Rank Correlation Coefficient Between IMPDH II Expression and Free Fraction|The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|BL and Weeks 2, 4, 12, and 24|ITT population; n=number of samples analyzed.||correlation coefficient|Participants||Number
835833|NCT01292226|Secondary|Spearman's Rank Correlation Coefficient Between IMPDH II Expression and MPA Levels|The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|BL and Weeks 2, 4, 12, and 24|ITT population; n=number of samples analyzed.||correlation coefficient|Participants||Number
835834|NCT01292226|Secondary|Spearman's Rank Correlation Coefficient Between IMPDH I Expression and Free Fraction|The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|BL and Weeks 2, 4, 12, and 24|ITT population; n=number of samples analyzed.||correlation coefficient|Participants||Number
835835|NCT01292226|Secondary|Spearman's Rank Correlation Coefficient Between IMPDH I Expression and MPA Levels|The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|BL and Weeks 2, 4, 12, and 24|ITT population; n=number of samples analyzed||correlation coefficient|Participants||Number
835836|NCT01292226|Secondary|Spearman's Rank Correlation Coefficient Between MPA Levels and IMPDH Activity|The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|BL and Weeks 2, 4, 12, and 24|ITT population; n=number of samples analyzed.||correlation coefficient|Participants||Number
835837|NCT01292226|Secondary|Percentage of Participants With Hematologic Toxicity|Hematological toxicities graded according to WHO worst grade observed (Grade 1=mild, Grade 2=moderate).|BL and Weeks 2, 4, 12, 24, and 28 (Safety Follow-Up)|Safety population||percentage of participants|||Number
835838|NCT01292226|Secondary|Percentage of Participants With Gastrointestinal Toxicities|Gastrointestinal adverse events (AEs) according to WHO worst grade observed.|BL and Weeks 2, 4, 12, 24, and 28 (Safety Follow-up Visit)|Safety population||percentage of participants|||Number
835839|NCT01292226|Secondary|Percentage of Participants With Infection|Infections were graded according to the World Health Organization (WHO) worst grade observed.|BL and Weeks 2, 4, 12, 24, and 28 (Safety Follow-Up)|Safety population: all enrolled participants||percentage of participants|||Number
835840|NCT01292226|Secondary|Tumor Necrosis Factor (TNF) Expression by Visit and Timepoint|TNF gene expression was measured by QRT-PCR based cytokine measurement of PBMCs at 2 timepoints per visit, 0 and 120 minutes and expressed as number of mRNA copies/cell.|BL and Weeks 2, 4, 12, and 24, and safety follow-up (Week 28) and any unscheduled visits|ITT population; n=number of samples analyzed.||number of mRNA copies/cell|Participants|Standard Deviation|Mean
835841|NCT01292226|Secondary|Interleukin 8 (IL-8) Expression by Visit and Timepoint|IL-8 gene expression was measured by QRT-PCR based cytokine measurement of PBMCs at 2 timepoints per visit, 0 and 120 minutes and expressed as number of mRNA copies/cell.|BL and Weeks 2, 4, 12, and 24, and safety follow-up (Week 28) and any unscheduled visits|ITT population; n=number of samples analyzed.||number of mRNA copies/cell|Participants|Standard Deviation|Mean
835842|NCT01292226|Secondary|IMPDH Expression II by Visit and Timepoint|IMPDH II gene expression was measured by QRT-PCR based cytokine measurement of PBMCs at 2 timepoints per visit, 0 and 120 minutes and expressed as number of mRNA copies/cell.|BL and Weeks 2, 4, 12, and 24, and safety follow-up (Week 28) and any unscheduled visits|ITT population; n=number of samples analyzed.||number of mRNA copies/cell|Participants|Standard Deviation|Mean
835843|NCT01292226|Secondary|IMPDH Expression I by Visit and Timepoint|IMPDH I gene expression was measured by real time polymerase chain reaction (QRT-PCR) based cytokine measurement of PBMCs at 2 timepoints per visit, 0 and 120 minutes and expressed as number of messenger ribonucleic acid (mRNA) copies per cell (copies/cell).|BL and Weeks 2, 4, 12, and 24, and safety follow-up (Week 28) and any unscheduled visits|ITT population; n=number of samples analyzed.||number of mRNA copies/cell|Participants|Standard Deviation|Mean
835844|NCT01292226|Secondary|Inosine MonoPhosphate DeHydrogenase (IMPDH) Activity by Visit and Timepoint|"IMPDH activity in peripheral blood mononuclear cells (PBMCs) was measured at 2 timepoints per visit, 0 and 120 minutes and presented in enzyme units. The unit of measure of enzyme activity is U. One U is defined as the amount of the enzyme that produces a certain amount of enzymatic activity that is, the amount that catalyzes the conversion of 1 micro mole of substrate per minute under pre-specified conditions (temperature, pH)."|BL and Weeks 2, 4, 12, and 24, and safety follow-up (Week 28) and any unscheduled visits|ITT population; n=number of samples analyzed.||enzyme units|Participants|Standard Deviation|Mean
835845|NCT01292226|Secondary|MPA Area Under the Concentration - Time Curve From Time 0 to 12 Hours (AUC0-12) (mcg/mL) by Visit|The AUC0-12 of MPA was estimated on the validated limited sampling strategy, AUC (milligrams multiplied by height over liter [mg.h/L]) = 7.182 + 4.607 multiplied by (*) concentration at 0 minutes (C0)+ 0.998 * the concentration at 40 minutes (C0.67) + 2.149 * the concentration at 120 minutes (C2).|Predose and 40 minutes and 2 hours postdose at Weeks 2, 4, 12, and 24, and at the Safety follow-up (Week 28)|ITT population; n=number of participants assessed for the specified parameter at a given visit.||mcg*hr/mL||Standard Deviation|Mean
835846|NCT01292226|Primary|Percentage of Participants With Biopsy-Proven Acute Rejection (BPAR)|BPAR was defined according to 1997 Banff Criteria as a biopsy Banff grade of IA, IB, IIA, IIB, or III. Grade IA was defined as significant interstitial infiltration with greater than (>)25% of parenchyma affected, and foci of moderate tubulitis with >4 mononuclear cells per tubular cross section or group of 10 tubular cells. Grade IB was defined as significant interstitial infiltration with >25% parenchyma affected, and foci of severe tubulitis with >10% mononuclear cells per tubular cross section or group of 10 tubular cells. Grade IIA was defined as mild to moderate intimal arteritis. Grade IIB was defined as severe intimal arteritis comprising >25% of the luminal area. Grade III was defined as transmural arteritis and/or arterial fibrinoid changes and necrosis of medial smooth muscle cells.|Day 1, Weeks 2, 4, 12, 24, and 28|ITT population||percentage of participants|||Number
835847|NCT01292226|Secondary|Free MPA (mcg/mL) by Visit|Drug quantification of free MPA in the plasma was measured at T = 0, 40, and 120 mins.|Weeks 2, 4, 12, 24, safety follow-up (Week 28), and any unscheduled visits|ITT population; n=number of samples analyzed.||mcg/mL|Participants|Standard Deviation|Mean
835848|NCT01292226|Secondary|Total Mycophenolate Acid (MPA) by Visit and Timepoint|Drug quantification of total MPA (micrograms per milliliter [mcg/mL]) in the plasma was measured at time (T) = 0 minutes (min), 40 mins, and 120 mins.|Weeks 2, 4, 12, 24, and 28 (Safety Follow-Up Visit), and any unscheduled visits|ITT population; n=number of samples analyzed.||mcg/mL|Participants|Standard Deviation|Mean
835849|NCT01292226|Secondary|Percentage of Participants Surviving||Day 1, Weeks 2, 4, 12, 24, and 28|ITT population||percentage of participants|||Number
835850|NCT01292226|Secondary|Percentage of Participants With Graft Loss|An allograft was presumed to be lost if a participant started dialysis and was not able to subsequently be removed from dialysis.|Day 1, Weeks 2, 4, 12, 24, and 28|ITT population||percentage of participants|||Number
835851|NCT01292226|Primary|Time to Rejection|The mean time, in days, from the date of enrollment to date of biopsy confirming acute rejection.|Day 1, Weeks 2, 4, 12, 24, and 28|ITT population; only participants with acute or biopsy-proven rejection were included in the analysis.||days||Standard Deviation|Mean
835852|NCT01292226|Primary|Percentage of Participants With Acute Rejection|Diagnosis of acute rejection was suspected in any participant with an increase in serum creatinine greater than or equal to (≥) 25 percent (%). All suspected acute rejections were confirmed by biopsy. The start date of acute rejection was identified as the date of biopsy.|Day 1, Weeks 2, 4, 12, 24, and 28|Intent-to-treat (ITT) population: all eligible participants who had at least baseline (BL) and 1 assessment of pharmacokinetics (PK) and pharmacodynamics (PD). Acute rejection was analyzed in any participant with an increase in serum creatinine of 25%.||percentage of participants|||Number
835853|NCT01292239|Secondary|Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24h) for TMC435|The table below shows the median (range) AUC24h values for TMC435 for all participants in the TMC435 treatment group who received TMC435 for up to 12 weeks. The time frame of “Overall” (up to Week 12) represents the median exposure estimate using all available data for each participant in the study.|Overall (Up to Week 12)|Pharmacokinetic (PK) analysis was performed in the PK population defined as all participants from whom sparse blood samples were drawn and who received at least 1 dose of study medication.||ng.h/mL||Full Range|Median
835854|NCT01292239|Secondary|Plasma Concentrations of TMC435|The table below shows median (range) predose plasma concentration (C0h) values and median (range) maximum plasma concentration (Cmax) values for TMC435 for all participants in the TMC435 treatment group. The time frame of “Overall” (up to Week 12) represents the median exposure estimate using all available data for each participant in the study.|Overall (ie, Up to Week 12)|Pharmacokinetic (PK) analysis was performed in the PK population defined as all participants from whom sparse blood samples were drawn and who received at least 1 dose of study medication.||ng/mL||Full Range|Median
835855|NCT01292239|Secondary|The Percentage of Participants in the TMC435 Treatment Group Who Met Response Guided Treatment (RGT) Criteria and Completed Treatment With Peginterferon Alpha-2a (PegIFN Alpha-2a) and Ribavirin (RBV) at Week 24|The table below shows the percentage of participants in the TMC435 treatment group who met RGT criteria (ie, who had plasma levels of hepatitis C virus ribonucleic acid [HCV RNA] <1.2 log10 IU/mL detectable/undetectable at Week 4 and <1.2 log 10 IU/mL undetectable at Week 12) and completed treatment with pegIFN alpha 2a and RBV at Week 24. Participants in the TMC435 treatment group not meeting RGT criteria and participants in the placebo group continued treatment with PegIFN alpha 2a and RBV to Week 48.|Week 24|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.||Percentage of participants|||Number
835856|NCT01292239|Secondary|The Number of Participants With Abnormal Alanine Aminotransferase (ALT) Levels at Baseline Who Achieved Normal ALT Levels at the End of Treatment (EOT)|The table below shows the number of participants with abnormal ALT levels at Baseline (Day 1) who achieved normal ALT levels at the EOT (up to Week 24 or 48). At Baseline, 61/123 participants in the TMC435 treatment group and 25/60 participants in the Placebo treatment group had abnormal ALT levels. At the EOT, 47 (77.0%) participants in the TMC435 treatment group and 18 (72.0%) participants in the Placebo treatment group had ALT levels that returned to normal (or normalization of ALT levels defined as an ALT value less than or equal to the Upper Limit of Normality [ie, 40 IU/mL] at EOT.).|Baseline (Day 1) to EOT (up to Week 24 or 48)|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.||Participants|||Number
835857|NCT01292239|Secondary|The Number of Participants Demonstrating Viral Relapse|The table below shows the number of participants who demonstrated viral relapse, defined as undetectable plasma levels of hepatitis C virus (HCV) ribonucleic acid (RNA) at the End of Treatment (EOT) (up to Week 24 or 48) and detectable HCV RNA during follow-up or detectable plasma levels of HCV RNA at the time points of sustained virologic response (SVR) assessment. The incidence of viral relapse was only calculated for participants with undetectable plasma levels of HCV RNA at the EOT and with at least one follow-up HCV RNA. measurement.|Up to Week 72|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.||Participants|||Number
835858|NCT01292239|Secondary|The Number of Participants With Viral Breakthrough|Viral breakthrough was defined as a confirmed increase of > 1 log10 IU/mL in plasma levels of hepatitis C virus (HCV) ribonucleic acid (RNA)l from the lowest level reached or a confirmed value of plasma HCV RNA of > 2.0 log10 IU/mL in participants whose plasma HCV RNA level had previously been below 1.2 log10 IU/mL detectable or undetectable during the treatment period (up to the end of treatment [EOT]).|Up to EOT (up to Week 24 or 48)|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.||Participants|||Number
835859|NCT01292239|Secondary|The Percentage of Participants With Undetectable Plasma Levels of Hepatitis C Virus Ribonucleic Acid (HCV RNA) During Treatment and at the End of Treatment (EOT)|The table below shows the percentage of participants with undetectable plasma levels of HCV RNA <1.2 log10 IU/mL during treatment at Weeks 4, 12, 24, 36, 48, 60, 72, and at the EOT (up to Week 24 or 48).|Weeks 4, 12, 24, 36, 48, 60, 72, and at EOT (up to Week 24 or 48)|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.||Percentage of participants|||Number
835860|NCT01292239|Secondary|The Percentage of Participants Who Achieved a Greater Than or Equal to 2 log10 IU/mL Drop From Baseline in Plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) at Each Time Point During Treatment and Follow-up|The table below shows the percentage of participants with greater than (>) or equal to (=) 2 log10 IU/mL drop from baseline in plasma levels of HCV RNA at each time point during treatment and post-treatment follow-up (FU).|Day 3, Day 7 and Weeks 2, 3, 4, 8, 12, 16, 20, 24, 28, 36, 42, 48, 52, 60, 72, EOT (up to Week 24 or 48), FU Week 4, 12, and 24|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.||Percentage of participants|||Number
835861|NCT01292239|Secondary|The Percentage of Participants With a Sustained Virologic Response at the End of Treatment (EOT) and 24 Weeks After the Last Dose of Treatment (SVR24)|The table below shows the observed percentage of participants with a SVR24 defined as undetectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) at the end of treatment (EOT, defined as up to Week 24 or 48) and at 24 weeks after the last dose of treatment (up to Week 48 or 72).|EOT (up to Week 24 or 48) and 24 weeks after the after the last dose of treatment (up to Week 48 or 72)|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.||Percentage of participants|||Number
835862|NCT01292239|Primary|The Percentage of Participants With a Sustained Virologic Response at the End of Treatment (EOT) and 12 Weeks After the Last Dose of Treatment (SVR12)|The table below shows the observed percentage of participants with a SVR12 defined as undetectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) at EOT (Week 24 or 48) and at 12 weeks after the last dose of treatment (Week 36 or 60).|EOT (up to Week 24 or 48) and 12 weeks after the EOT (up to Week 36 or 60)|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.||Percentage of participants|||Number
835863|NCT01292265|Secondary|Change From Baseline (Week 0) in Erythrocyte Sedimentation Rate (ESR) at Week 12||From Baseline (Week 0) to Week 12|Since only 3 subjects were enrolled in this study, the efficacy data is not interpretable and will not be presented.|||||
835864|NCT01292265|Secondary|Change From Baseline (Week 0) in C-reactive Protein (CRP) at Week 12||From Baseline (Week 0) to Week 12|Since only 3 subjects were enrolled in this study, the efficacy data is not interpretable and will not be presented.|||||
835865|NCT01292265|Secondary|Change From Baseline (Week 0) in the Clinical Disease Activity Index (CDAI) at Week 12||From Baseline (Week 0) to Week 12|Since only 3 subjects were enrolled in this study, the efficacy data is not interpretable and will not be presented.|||||
835866|NCT01292265|Primary|Change From Baseline (Week 0) in the Modified Ultrasound-7 Joint (mUS7) Sumscore at Week 12||From Baseline (Week 0) to Week 12|Since only 3 subjects were enrolled in this study, the efficacy data is not interpretable and will not be presented.|||||
835867|NCT01292304|Secondary|Time From Baseline to Worsening Ascites (Requiring 1 or More Therapeutic Paracentesis to Remove Ascites Fluid)|This outcome will describe the average time from baseline for subjects to require a therapeutic paracentesis to remove ascites fluid.|12 weeks of study drug|||Days||Full Range|Median
835868|NCT01292304|Primary|Number of Subjects With Worsening Ascites (Defined as Greater Than 2 kg Weight Gain)|This outcome will provide the number of subjects with a weight increase of > 2kg from baseline (worsening ascites)|12 weeks of study drug|||participants|||Number
835869|NCT01292304|Secondary|Number of Patients With Abnormally Low Levels of Sodium (Sodium Levels Between 130 mmol/L and 135 mmol/L)|Number of Patients with new episodes of hyponatremia (abnormally low levels of sodium) defined as sodium >130 mmol/L and <135 mmol/L|12 weeks|||participants|||Number
835870|NCT01292304|Secondary|Number of Patients With Reduction of Ascites (Weight Loss of 2 kg or More)|Number of patients with reduction of ascites is defined as reduction of weight by at least 2 kg during study drug dosing|12 weeks|||participants|||Number
835871|NCT01292304|Primary|Number of Participants With Worsening Ascites (Increase in Number of Paracentesis Procedures to Remove 2 Liters of Ascites Fluid)|Increase in number of therapeutic paracentesis (removal of > 2 litres of ascites fluid) during 12 weeks of study drug dosing versus 12 weeks before study drug dosing|Week 12|||participants|||Number
835872|NCT01292473|Secondary|Percentage of Angioedema-free Days From Week 4 to Week 12|The percentage of angioedema-free days from Weeks 4 to 12 was defined as the number of days a patient reported as angioedema-free in the daily diary divided by the total number of days with a non-missing diary entry, starting at the Week 4 visit and ending the day prior to the Week 12 visit.|Week 4 to Week 12|Modified intent-to-treat population: All randomized patients who received at least one dose of study drug. Patients who withdrew before the Week 4 visit or who had missing responses for more than 40% of the daily diary entries between the Week 4 visit and the Week 12 visit were not included in the analysis.||Percentage of days||Standard Deviation|Mean
835873|NCT01292473|Secondary|Change From Baseline in the Overall Dermatology Life Quality Index (DLQI) at Week 12|The dermatology life quality index (DLQI) is a 10-item dermatology-specific health-related quality of life measure. Participants rate their dermatology symptoms as well as the impact of their skin condition on various aspects of their lives on a scale of 0 (Not at all) to 3 (Very much). The overall DLQI is the sum of the responses to the 10 items and ranges from 0 to 30. A lower score indicates a better quality of life. A negative change score indicates improvement.|Baseline, Week 12|Modified intent-to-treat population: All randomized patients who received at least one dose of study drug and who had a DLQI score at Week 12.||Units on a scale||Standard Deviation|Mean
835874|NCT01292473|Secondary|Change From Baseline in the Weekly Size of the Largest Hive Score at Week 12|The size of the largest hive is assessed twice daily (morning and evening) on a scale of 0 (none) to 3 (> 2.5 cm). The daily score is the average of the morning and evening scores. The weekly size of the largest hive score is the sum of the daily scores over 7 days, and ranges from 0 to 21. The Baseline weekly size of the largest hive score is the sum of daily scores over the 7 days prior to the first treatment. A higher score indicates larger hives. A negative change score indicates a reduction in hive size.|Baseline, Week 12|Modified intent-to-treat population: All randomized patients who received at least one dose of study drug.||Units on a scale||Standard Deviation|Mean
835875|NCT01292473|Secondary|Percentage of Weekly Itch Severity Score MID Responders at Week 12|"The weekly itch severity score is the sum of the daily itch severity scores over 7 days and ranges from 0 to 21. The daily itch severity score is the average of the morning and evening scores on a scale of 0 (none) to 3 (severe). The Baseline weekly itch severity score is the sum of the daily itch severity scores over the 7 days prior to the first treatment. A higher itch severity score indicates more severe itching. A negative change score indicates improvement.
The MID response for weekly itch severity score was defined as a reduction from baseline in weekly itch severity score of 5 points or more. This outcome measure shows the percentage of participants classified as MID Responders at Week 12, meaning their weekly itch severity scores at Week 12 were at least 5 points lower than at Baseline."|Baseline, Week 12|Modified intent-to-treat population: All randomized patients who received at least one dose of study drug.||Percentage of participants|||Number
835876|NCT01292473|Secondary|Percentage of Participants With a UAS7 Less Than or Equal to 6 at Week 12|The urticaria activity score (UAS) is a composite of scores on a scale of 0 (none) to 3 (intense/severe) for 1) the number of wheals (hives); and 2) the intensity of the itch, measured twice daily (morning and evening). Daily UAS is the average of morning and evening scores (ranging from 0-6) and the UAS7 is the sum of the daily UAS over 7 days (ranging from 0-42). Baseline UAS7 is calculated using data from the 7 days prior to the first treatment date. A higher UAS indicates more urticaria activity. A negative change score indicates improvement.|Week 12|Modified intent-to-treat population: All randomized patients who received at least one dose of study drug.||Percentage of participants|||Number
835877|NCT01292473|Secondary|Time to Minimally Important Difference (MID) Response in the Weekly Itch Severity Score by Week 12|"The weekly itch severity score is the sum of the daily itch severity scores over 7 days and ranges from 0 to 21. The daily itch severity score is the average of the morning and evening scores on a scale of 0 (none) to 3 (severe). The Baseline weekly itch severity score is the sum of the daily itch severity scores over the 7 days prior to the first treatment. A higher itch severity score indicates more severe itching. A negative change score indicates improvement.
The MID response for weekly itch severity score was defined as a reduction from baseline in weekly itch severity score of 5 points or more. The time to weekly itch severity score MID response was defined as the time (in weeks) from Day 1 to the study week when weekly itch severity score MID response was first achieved."|by Week 12|Modified intent-to-treat population: All randomized patients who received at least one dose of study drug.||Weeks||95% Confidence Interval|Median
835878|NCT01292473|Secondary|Change From Baseline in the Weekly Number of Hives Score at Week 12|The weekly hives score is the sum of the daily hives scores over 7 days and ranges from 0 to 21. The number of hives is measured twice daily (morning and evening) on a scale of 0 (none) to 3 (> 12 hives per 12 hours). The daily hives score is the average of the morning and evening scores. The Baseline score is the sum of the daily hives scores over the 7 days prior to the first treatment. A higher score indicates more hives. A negative change score indicates improvement.|Baseline, Week 12|Modified intent-to-treat population: All randomized patients who received at least one dose of study drug.||Units on a scale||Standard Deviation|Mean
835879|NCT01292473|Secondary|Change From Baseline in the Weekly Urticaria Activity Score (UAS7) at Week 12|The urticaria activity score (UAS) is a composite of scores on a scale of 0 (none) to 3 (intense/severe) for 1) the number of wheals (hives); and 2) the intensity of the itch, measured twice daily (morning and evening). Daily UAS is the average of morning and evening scores (ranging from 0-6) and the UAS7 is the sum of the daily UAS over 7 days (ranging from 0-42). Baseline UAS7 is calculated using data from the 7 days prior to the first treatment date. A higher UAS indicates more urticaria activity. A negative change score indicates improvement.|Baseline, Week 12|Modified intent-to-treat population: All randomized patients who received at least one dose of study drug.||Units on a scale||Standard Deviation|Mean
835880|NCT01292473|Primary|Change From Baseline in the Weekly Itch Severity Score at Week 12|The weekly itch severity score is the sum of the daily itch severity scores over 7 days and ranges from 0 to 21. The daily itch severity score is the average of the morning and evening scores on a scale of 0 (none) to 3 (severe). The Baseline weekly itch severity score is the sum of the daily itch severity scores over the 7 days prior to the first treatment. A higher itch severity score indicates more severe itching. A negative change score indicates improvement.|Baseline, Week 12|Modified intent-to-treat population: All randomized patients who received at least one dose of study drug.||Units on a scale||Standard Deviation|Mean
835881|NCT01292486|Secondary|Granulocyte % of MNC Product|Granulocyte contamination of the MNC product was quantitated as the percent of total product White Blood Cells (WBC) that were segmented granulocytes or bands.|7 days|Data to calculate the percent of product WBCs that were segmented granulocytes or bands was available for 38 MNC collections on 25 of the 26 per protocol patients.||percentage of product WBCs|Participants|Full Range|Median
835882|NCT01292486|Secondary|Hematocrit of MNC Product|The hematocrit of the collected product was used to quantitate Red Blood Cell (RBC) contamination.|7 days|Data was available from 38 MNC collections from 25 of the 26 per protocol patients.||hematocrit %|Participants|Full Range|Median
835883|NCT01292486|Secondary|Platelet Collection Efficiency|Platelet contamination of the cell product was measured as the platelet collection efficiency, that is, as the percent of platelets processed that were collected.|up to 7 days|Data to calculate platelet collection efficiency was available for 38 MNC collections on 24 of the 26 per protocol patients.||% of processed platelets collected|Participants|Full Range|Median
835884|NCT01292486|Secondary|Mononuclear Cel (MNC) Collection Efficiency|"Collection efficiency (CE) is defined as the percentage of any given cellular subset, processed by the system, that is collected from the subject.
Determination of collection efficiency depends on an estimate of the average concentration of target cells in the patient's blood. Because these cells are continuously being removed during the collection, and are undergoing variable replacement from the bone marrow, this estimate will not be completely accurate. Underestimation of the concentration of target cells processed can lead to collection efficiencies of greater than 100%."|up to 7 days|Data was available to calculate MNC collection efficiency on 35 collections performed on 22 of the 26 per protocol patients.||% of processed MNCs that were collected|Participants|Full Range|Median
835885|NCT01292486|Secondary|CD34+ Cell Collection Efficiency.|"Collection efficiency (CE) is defined as the percentage of any given cellular subset, processed by the system, that is collected from the subject.
CD34+ is a cell surface marker found on pluripotent hematopoeitic stem cells."|up to 7 days|Data to calculate CD34+ cell collection efficiency was available for 39 collections on 24 of 26 per protocol patients.||% of processed CD34+ cells collected|Participants|Full Range|Median
835886|NCT01292486|Secondary|Days Until Platelet Recovery|The time to platelet recovery is defined as the day following stem-cell transplant (Day 0) on which the platelet count exceeds 20,000/μL, for the first of three consecutive measurements obtained on different days, without platelet transfusion support within the preceding 7 days.|up to 28 days following transplant|All per protocol patients for whom platelet recovery data was available.||days||Full Range|Median
835887|NCT01292486|Primary|Days Until Neutrophil Recovery Following Peripheral Blood Stem Cell Transplant Minus the Historical Median Day Until Recovery.|"Neutrophil recovery is defined as the day on which the peripheral blood absolute neutrophil count exceeds 500/μL (ANC500)for the first of three consecutive measurements obtained on different days following transplant of peripheral blood stem cells in patients treated with myeloablative therapy for their underlying disease.
As this was a test of non-inferiority, the null hypothesis to be tested (H0) was that the difference between the observed day to neutrophil recovery and the historical median day of neutrophil recovery was greater than two days. At two of the enrolling sites, Duke and Emory Universities, the median day to ANC500 was 12, while at the other two sites, Indiana University and the University of Utah, it was 11 days. Consequently, in the equation below, site specific-historic medians were compared to the observed days to achieve ANC500. H0: D > |2|, where D = Observed median day of neutrophil recovery – Site specific historic median day of neutrophil recovery."|up to 28 days following transplant|Twenty-six patients were evaluable per protocol.||Days||Full Range|Median
835888|NCT01292538|Secondary|Body Weight (Pounds)||2 weeks||||||
835889|NCT01292538|Secondary|Subject Self-reported Satisfaction With Study Outcome||2 weeks||||||
835890|NCT01292538|Secondary|Body Mass Index (BMI)||2 weeks||||||
835891|NCT01292538|Primary|Combined Circumference in Inches of the Waist, Hips and Bilateral Thighs|Mean change in total combined circumference inches of the waist, hips and bilateral thighs from baseline to endpoint evaluation.|2 weeks|||inches||Standard Deviation|Mean
835892|NCT01292603|Secondary|Part 2: Percentage of Participants With Total B-Cell Depletion by Visit|Total B-cell depletion (normal B-cell plus Malignant B-cell depletion) was defined for each individual participant when the sum of CD5-/CD19+ (normal B-cells) and CD5+/CD19+ (malignant B-cells) cell counts decreased below 80 cells/μL.|Cycle 1 Pre-dose, 60 minutes post-dose, Days 2 and 3 in Cycle 2, day 1 in Cycles 3, 4, 5 and 6, Follow-up Days 28 and 56, and Follow-up Visits at Months 3, 6, 9, 12, 15, and 18 and Withdrawal Visit|Part 2 SAP; n= number of participants analyzed at the specified visit.||percentage of participants|||Number
835893|NCT01292603|Secondary|Part 2: Total CD19+ B-Cell Counts by Visit|CD 19 is a surface antigen (protein) present on B-lymphocytes.|Cycle 1 pre-dose, 60 minutes post-dose, Days 2 and 3 in Cycle 2, day 1 pre-dose in Cycles 3, 4, 5 and 6, Follow-up Days 28 and 56, and Follow-up Visits at Months 3, 6, 9, 12, 15, and 18 and Withdrawal Visit|Part 2 SAP; n = number of participants analyzed at the specified visit.||cells/μL||Full Range|Median
835894|NCT01292603|Secondary|Part 1: Percentage of Participants With Total B-Cell Depletion by Visit|Total B-cell depletion (normal B-cell plus Malignant B-cell depletion) was defined for each individual participant when the sum of CD5-/CD19+ (normal B-cells) and CD5+/CD19+ (malignant B-cells) cell counts decreased below 80 cells/μL.|Day 1 pre-dose of Cycles 5 and 6 and Follow-up Days 28 and 56 and Follow-up Visits at Months 3, 6, 9, 12, 15, 18, 21 and 24|Part 1 SAP; n = number of participants analyzed at the specified visit.||percentage of participants|||Number
835895|NCT01292603|Secondary|Part 1: Total Cluster Differentiation19 Positive (CD19+) B-Cell Counts by Visit|CD 19 is a surface antigen (protein) present on B-lymphocytes.|Day 1 of Cycles 5 and 6 and Follow-up Days 28 and 56 and Follow-up Visits at Months 3, 6, 9, 12, 15,18, 21 and 24|Part 1 SAP; n = number of participants analyzed at the specified visit.||cells per microliter (cells/μL)||Full Range|Median
835896|NCT01292603|Secondary|Part 2: Percentage of Participants With Anti-Rituximab Antibodies|In Part 2, samples for the HACA assay were collected at each treatment cycle prior to the administration of rituximab and at each follow-up visit until 24 months after the last dose of rituximab.|Day 0 of Cycle 1 and Day 1 of Cycles 1, 2, 3, 4, 5, and 6 and at each follow-up visit until 24 months after the last dose of rituximab.|SAP; n = number of participants analyzed for the specific parameter.||percentage of participants|||Number
835897|NCT01292603|Secondary|Part 1: Percentage of Participants With Anti-Rituximab Antibodies|Blood samples for the assessment of antibodies against rituximab (HACAs) were drawn pre-dose at Cycle 5 and Cycle 6 in Part 1 and at each follow up visit until 24 months after the last dose.|Predose at Cycles 5 and 6 and at each follow up visit until 24 months after the last dose|Safety Analysis Population (SAP): all participants who received at least one dose of study medication, whether prematurely withdrawn from the study or not. This included 8 participants that did not receive SC rituximab. n = number of participants analyzed.||percentage of participants|||Number
836214|NCT01286324|Secondary|To Evaluate Any Changes From Baseline in the Safety and Tolerability of Chamomile|To evaluate any changes from baseline in the safety and tolerability of Chamomile High Grade Extract, three tablets (equivalent to 7.5g of dried herb) p.o. twice times daily versus placebo.|once per week during study and day 28||||||
835898|NCT01292603|Secondary|Part 2: Physician/Nurse Opinion on Convenience of Rituximab SC Compared With Rituximab IV|"Physicians and nurses who administered rituximab were asked to answer the following question: Which formulation of rituximab (SC or IV) do you think is more convenient? with pre-specified responses as below. Percentage of participants with specified answers were reported.
A - Rituximab SC is much more convenient.
B - Rituximab SC is a little more convenient.
C - Both formulations are equally convenient.
D - Rituximab IV is a little more convenient.
E - Rituximab IV is much more convenient"|Days 4-5 in Cycle 6|All the physicians and nurses who responded to the questionnaire were included in the analysis. n = number of physicians or nurses that responded to the survey.||percentage of participants in the survey|||Number
835899|NCT01292603|Secondary|Part 2: Physician/Nurse Opinion on Time Savings With Rituximab SC Compared With Rituximab IV|"Physicians and nurses who administered rituximab were asked to answer the following question:  If used in routine practice, on average, how much staff time could be saved with each administration of rituximab SC as compared to rituximab IV? (Please do not consider the time needed for the first IV administration, consider only the subsequent ones). Percentage of participants with specified answers were reported.
A- Less than 1 hour
B- At least 1 hour but less than 2 hours
C- At least 2 hours but less than 3 hours
D- At least 3 hours but less than 4 hours
E- 4 or more hours"|Days 4-5 in Cycle 6|All the physicians and nurses who responded to the questionnaire were included in the analysis. number (n) = number of physicians or nurses that responded to the survey.||percentage of participants in the survey|||Number
835900|NCT01292603|Secondary|Part 1: Percentage of Participants and Nurses Recording a Preference For Either SC or IV Administration|In part 1 of the trial, upon completion of dosing in cycle 6, participants and their treating nurses were asked whether they have a preference of dosing route, IV vs SC|Days 4 to 5 in Cycle 6|All participants in Part 1 were included in this analysis including 8 participants that did not receive SC rituximab.||percentage of participants or nurses|||Number
835901|NCT01292603|Secondary|Part 2: Terminal Half-Life of Rituximab at Cycle 6|The terminal half-life (t1/2) of rituximab is defined as the time required for the plasma concentration of rituximab to reach half of its original concentration.|Rituximab IV arm: pre-dose, post-dose and on Days 2, 3, 8 ,15, 29 of Cycle 6; Rituximab SC arm: pre-dose, and on Days 2, 3, 8 ,15, 29 of Cycle 6|Only participants who entered Part 2 of the study and had PK data available were included in the analysis.||days||Geometric Coefficient of Variation|Geometric Mean
835902|NCT01292603|Secondary|Part 2: Time to Cmax (Tmax) of Rituximab at Cycle 6|Multiple blood samples were obtained at pre-dose, post-dose and on Days 2, 3, 8 ,15, 29 of Cycle 6 in Rituximab IV arm, and at pre-dose, and on Days 2, 3, 8 ,15, 29 of Cycle 6 in Rituximab SC arm and time to peak plasma concentration of rituximab was determined.|Rituximab IV arm: pre-dose, post-dose and on Days 2, 3, 8 ,15, 29 of Cycle 6; Rituximab SC arm: pre-dose, and on Days 2, 3, 8 ,15, 29 of Cycle 6|Only participants who entered Part 2 of the study and had PK data available were included in the analysis.||days||Geometric Coefficient of Variation|Geometric Mean
835903|NCT01292603|Secondary|Part 2: Maximum Observed Concentration (Cmax) of Rituximab at Cycle 6|Cmax was obtained directly from the measured concentration-time curves. The concentration-time curve is the result of time points of blood sampling and its measured concentration of rituximab in the blood samplings.|Rituximab IV arm: pre-dose, post-dose and on Days 2, 3, 8 ,15, 29 of Cycle 6; Rituximab SC arm: pre-dose, and on Days 2, 3, 8 ,15, 29 of Cycle 6|Only participants who entered Part 2 of the study and had PK data available were included in the analysis.||μg/mL||Geometric Coefficient of Variation|Geometric Mean
835904|NCT01292603|Secondary|Part 2: Observed Area Under the Serum Concentration-Curve (AUC) of Rituximab at Cycle 6|"AUC values were calculated by numerical integration using the linear trapezoidal rule. AUC levels were analyzed using the model below:
Ln(AUC) = μ + τi + BlTLij + εij wherein, Ln is the natural log, μ denotes the overall mean effect, τi the effect in each treatment group, BlTLij the tumor load at baseline for each patient and εij a random error variable with normal distribution and mean 0. The treatment effect therein was based on a contrast statement in the model to calculate 90 % confidence intervals for ln(AUC SC)– ln(AUC IV)."|Rituximab IV arm: pre-dose, post-dose and on Days 2, 3, 8 ,15, 29 of Cycle 6; Rituximab SC arm: pre-dose, and on Days 2, 3, 8 ,15, 29 of Cycle 6|Only participants who entered Part 2 of the study and had PK data available were included in the analysis.||μg*day/mL||Geometric Coefficient of Variation|Geometric Mean
835905|NCT01292603|Primary|Part 2: Rituximab C Trough Levels at Cycle 5|Ctrough is defined as the trough or minimum serum concentration in a given cycle of treatment. The objective of Part 2 was to demonstrate the comparability of the observed Ctrough of rituximab SC 1600 mg and rituximab IV 500 mg/m2 at Cycle 5, as assessed by a non-inferiority test with a lower boundary of at least 0.8 for the 90% CI.|+/- 25hours around the 28th day post the 5th Cycle of Rituximab administration|Only participants who entered Part 2 of the study and had pharmacokinetic (PK) data available were included in the analysis.||μg/mL||Geometric Coefficient of Variation|Geometric Mean
835906|NCT01292603|Primary|Part 1: Subcutaneous Rituximab Dose Resulting in Trough Concentration (Ctrough) Levels Non-Inferior to Intravenous Rituximab|Ctrough is defined as the trough or minimum serum concentration. Pharmacokinetic parameters for rituximab were assessed during Cycles 5 (IV rituximab) and 6 (SC rituximab). Rituximab pharmacokinetic (PK) data from Part 1 were integrated into a population PK model using parametric, nonlinear, mixed-effects modelling. Rituximab IV 500 mg/m^2 administered once every 4 weeks was compared to fixed doses of rituximab SC between 1400 mg and 1870 mg. The dose selection was performed on Ctrough concentrations at Cycle 5 (pre-dose Cycle 6). A test of the probability of success was applied to each of the 100 replicates, and the percentage of replicates with a positive test corresponded to the probability of success of the trial.|Pre-dose and post-dose (15 minutes to end of infusion) on Day 1 and on Days 2, 5, 11 and 15 of Cycle 5 and Pre-dose, Post-dose on Days 2, 3, 5,11, 15 and 29 of Cycle 6; Pre-dose was taken 2 hours prior rituximab dose|Enrolled (non-randomized) Pharmacokinetic Evaluable Population (Part 1) included all participants from Part 1 who did not significantly violate the inclusion or exclusion criteria, deviate significantly from the protocol or have unavailable or incomplete data which could influence the pharmacokinetic analysis.||mg|||Number
835907|NCT01292629|Secondary|Complications and Adverse Events|Number of Participants with Complications or Adverse Events|4 to 6 months|||participants|||Number
835908|NCT01292629|Primary|Visual Acuity|BEST Spectacle-Correction (ETDRS) Distance Visual Acuity|4 to 6 months|125 subjects enrolled in the study, 121 were examined at the Form 4 and the remaining four (3.2%) subjects missed the Form 4 visit but were examined later. 121 subjects were evaluated for primary and secondary effectiveness and safety outcomes.||subjects|||Number
835909|NCT01292642|Secondary|Client Satisfaction Questionnaire (CSQ-8) at 10 Weeks|The Client Satisfaction Questionnaire (CSQ-8) is a self-report instrument used to assess satisfaction with health services and it was used to assess participant satisfaction with the treatment during this 10 week study. Scores range from 8 - 32 with higher values indicating higher satisfaction.|10 weeks|||Scores on a scale||Standard Deviation|Mean
835910|NCT01292642|Primary|Cannabis Use|cannabis inhalations per day|Baseline and 10 weeks|||cannabis inhalations/day||Standard Deviation|Mean
835911|NCT01292642|Primary|Cigarette Use|cigarettes per day|Baseline and 10 weeks|||cigarettes/day||Standard Deviation|Mean
835912|NCT01284296|Primary|Categorical Groups Based on Magnitude of Differences Between Noninvasive (SpHb) and Laboratory Co-Oximeter (tHb) Hemoglobin in Patients With a Finger Regional Anesthetic Block.||A minimum of 2-4 differences recorded approximately hourly during surgery|||percentage of hemoglobin readings|Participants||Number
835913|NCT01284361|Secondary|Assessment of Ease of Use Characteristics|"Ease of insertion, removal, and control while catheterizing were assessed using a 5 point Likert scale. The numbers recorded are the percentage of the top two responses on a 5 point Likert scale. On one scale this includes 1) Very Easy or 2) Easy, on a scale ranging from 1) Very Easy to 5) Very Difficult. On the other scale this includes 1) Strongly Agree or 2) Agree on a scale ranging from 1) Strongly Agree to 5) Strongly Disagree."|1 week|82 self-catheterizing wheelchair-using men||percentage of participants|||Number
835914|NCT01284361|Primary|Percentage of Participants|Percentage of participants that preferred the 40 cm catheter|1 week|||percentage of participants|||Number
835915|NCT01284426|Primary|Duration of Urticaria Until Remission Since Chronic Urticaria Was Diagnosed.|"Remission rates at 1, 3 and 5 years after the onset of symptoms of chronic urticaria.
Description in details:
Actually, this study have been started in March 2003 and finally done in March 2009, which would be totally 6 years. We eventually decided to report the rate of CU remissions only at 1, 3 and 5 years after the onset of symptoms because this would be the common interval time of CU symptoms that patients needed to know how long they should have those CU symptoms or how many of them would go away their symptoms within 1, 3 or 5 years. Another reason is that the remission rate of CU between 5 and 6 years was not significantly different, so it might not need to be reported."|6 years|Children 4-15 years old with chronic urticaria||percentage of participants|||Number
835916|NCT01284491|Primary|Scar Quality|The primary endpoint will be the difference in scar quality (color, thickness, stiffness, pliability, etc.) between the scalpel and PlasmaBlade skin incisions.|0-18 months following breast reduction surgery|An integrity audit found that the data for this study could not be analyzed owing to unverifiable source documentation.|||||
835920|NCT01284517|Secondary|Mean Change From Baseline to Endpoint (Week 6) in: Sheehan Disability Scale (SDS) Total Score|SDS total score ranges from a minimum of 0 to a maximum of 30. Lower values represent a better score, higher values represent a worse score. Similarly, greater negative change from baseline represents improvement, and positive changes from baseline represent worsening.|Baseline to week 6|Full analysis set (intent-to-treat population)||units on a scale||Standard Error|Least Squares Mean
835921|NCT01284517|Secondary|Mean Change From Baseline to Endpoint (Week 6) in: Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression)|CGI-EP-S depression score ranges from a minimum of 0 to a maximum of 7. Lower values represent a better score, higher values represent a worse score. Similarly, greater negative change from baseline represents improvement, and positive changes from baseline represent worsening.|Baseline to week 6|Full analysis set (intent-to-treat population)||units on a scale||Standard Error|Least Squares Mean
835922|NCT01284517|Primary|Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Endpoint (Week 6)|MADRS total score ranges from a minimum of 0 to a maximum of 60. Lower values represent a better score, higher values represent a worse score. Similarly, greater negative change from baseline represents improvement, and positive changes from baseline represent worsening.|Baseline to week 6|Full analysis set (intent-to-treat population)||units on a scale||Standard Error|Least Squares Mean
835923|NCT01284621|Secondary|Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Blood Chemistry and Tolerability|Clinically relevant abnormalities for physical examination, vital signs, ECG, blood chemistry and assessment tolerability by the investigator. New abnormal findings or worsening of baseline conditions were reported as adverse events.|From drug administration until end of washout period (36 days)|Treated set which included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.||participants|||Number
835924|NCT01284621|Secondary|Apparent Volume of Distribution During the Terminal Phase (Vz/Fss)|Apparent volume of distribution at steady-state during the terminal phase λz following an extravascular dose.|0 hours (h), 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration on day 5. In addition pre-dose samples, 5 minutes predose, were collected on days 1 to 4|Pharmacokinetic (PK) set: All subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.||L||Geometric Coefficient of Variation|Geometric Mean
835925|NCT01284621|Secondary|Apparent Clearance After Extravascular Administration (CL/Fss)|Apparent clearance of the analyte in plasma after extravascular administration at steady-state.|0 hours (h), 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration on day 5. In addition pre-dose samples, 5 minutes predose, were collected on days 1 to 4|Pharmacokinetic (PK) set: All subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.||mL/min||Geometric Coefficient of Variation|Geometric Mean
835926|NCT01284621|Secondary|Mean Residence Time (MRTpo,ss)|Mean residence time of the analyte in the body after oral administration at steady-state.|0 hours (h), 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration on day 5. In addition pre-dose samples, 5 minutes predose, were collected on days 1 to 4|Pharmacokinetic (PK) set: All subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.||hours||Geometric Coefficient of Variation|Geometric Mean
835927|NCT01284621|Secondary|Terminal Half-life (T 1/2,ss)|Terminal half-life of the analyte in plasma at steady-state.|0 hours (h), 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration on day 5. In addition pre-dose samples, 5 minutes predose, were collected on days 1 to 4|Pharmacokinetic (PK) set: All subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.||hours||Geometric Coefficient of Variation|Geometric Mean
835928|NCT01284621|Secondary|Terminal Rate Constant (λz,ss)|Terminal rate constant in plasma at steady-state|0 hours (h), 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration on day 5. In addition pre-dose samples, 5 minutes predose, were collected on days 1 to 4|Pharmacokinetic (PK) set: All subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.||1/h||Geometric Coefficient of Variation|Geometric Mean
835929|NCT01284621|Secondary|Time From Last Dosing to the Maximum Measured Concentration (Tmax,ss)|Time from last dosing to the maximum measured concentration of the analyte in plasma at steady state.|0 hours (h), 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration on day 5. In addition pre-dose samples, 5 minutes predose, were collected on days 1 to 4|Pharmacokinetic (PK) set: All subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.||hours||Full Range|Median
835930|NCT01284621|Secondary|Ramiprilat: Predose Concentration Prior to Administration of the Nth Dose (Cpre,N)|"Predose concentration of the analyte in plasma prior to administration of the Nth dose, of ramiprilat.
Note, predose concentrations for ramipril were all below the limit of quantification (BLQ) and therefore the predose concentration of the analyte in plasma prior to administration of the Nth dose, of ramipril was not analysed."|0 hours (h), 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration on day 5. In addition pre-dose samples, 5 minutes predose, were collected on days 1 to 4|Pharmacokinetic (PK) set: All subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
835931|NCT01284621|Secondary|Empa: Predose Concentration Prior to Administration of the Nth Dose (Cpre,N)|Predose concentration of the analyte in plasma prior to administration of the Nth dose, of empagliflozin.|0 hours (h), 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration on day 5. In addition pre-dose samples, 5 minutes predose, were collected on days 1 to 4|Pharmacokinetic (PK) set: All subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
835932|NCT01284621|Primary|Total Ramiprilat: Maximum Measured Concentration (Cmax,ss)|Maximum measured concentration of the analyte in plasma at steady-state over a uniform dosing interval, τ, of ramiprilat.|0 hours (h), 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration on day 5. In addition pre-dose samples, 5 minutes predose, were collected on days 1 to 4|Pharmacokinetic (PK) set: All subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
835933|NCT01284621|Primary|Total Ramiprilat: Area Under the Curve at Steady-state Over a Uniform Dosing Interval (AUCτ,ss).|Area under the concentration-time curve of the analyte in plasma at steady-state over a uniform dosing interval τ, of ramiprilat (active metabolite of ramipril).|0 hours (h), 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration on day 5. In addition pre-dose samples, 5 minutes predose, were collected on days 1 to 4|Pharmacokinetic (PK) set: All subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
835934|NCT01284621|Primary|Total Ramipril: Maximum Measured Concentration (Cmax,ss)|Maximum measured concentration of the analyte in plasma at steady-state over a uniform dosing interval, τ, of ramipril.|0 hours (h), 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration on day 5. In addition pre-dose samples, 5 minutes predose, were collected on days 1 to 4|Pharmacokinetic (PK) set: All subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
835935|NCT01284621|Primary|Total Ramipril: Area Under the Curve at Steady-state Over a Uniform Dosing Interval (AUCτ,ss).|Area under the concentration-time curve of the analyte in plasma at steady-state over a uniform dosing interval τ, of ramipril.|0 hours (h), 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration on day 5. In addition pre-dose samples, 5 minutes predose, were collected on days 1 to 4|Pharmacokinetic (PK) set: All subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
836232|NCT01286558|Secondary|Seated Blood Pressure (BP) Normalisation at Trough|Seated blood pressure (BP) normalisation: The numbers of patients whose blood pressure was within normalisation criterion in terms of seated blood pressure after the 8-week double-blind period At trough: 24-hour post-dosing|8 weeks|FAS||participants|||Number
835936|NCT01284621|Primary|Total Empa: Maximum Measured Concentration (Cmax,ss)|Maximum measured concentration of the analyte in plasma at steady-state over a uniform dosing interval, τ, of empagliflozin (empa).|0 hours (h), 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration on day 5. In addition pre-dose samples, 5 minutes predose, were collected on days 1 to 4|Pharmacokinetic (PK) set: All subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
835937|NCT01284621|Primary|Total Empa: Area Under the Curve at Steady-state Over a Uniform Dosing Interval (AUCτ,ss)|Area under the concentration-time curve of the analyte in plasma at steady-state over a uniform dosing interval τ, of empagliflozin (empa).|0 hours (h), 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration on day 5. In addition pre-dose samples, 5 minutes predose, were collected on days 1 to 4|Pharmacokinetic (PK) set: All subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
835938|NCT01284634|Secondary|Incidence of Adverse Events (AEs) as a Measure of Patient Safety|All reported AEs were classified by system organ class (SOC), preferred term (PT) and low level term using version 13.1 of the MedDRA dictionary. The number of subjects who experienced an AE during the study is presented.|From 0 -10 weeks (study duration)|All randomised subjects were analysed.||participants|||Number
835939|NCT01284634|Secondary|Change From Baseline to the End of Treatment in Mean Fasting Serum Insulin|A fasting blood sample was obtained for the measurement of fasting serum insulin. An increase from baseline (i.e. a positive value) indicates an improvement in condition.|After 56 days of treatment|A reduction from baseline (i.e. a negative value) indicates an improvement in condition.||pmol/l||Standard Deviation|Mean
835940|NCT01284634|Secondary|Change From Baseline to the End of Treatment in Mean Total Fat as a Percentage of Body Weight|A reduction from baseline (i.e. a negative value) in the amount of fat as a percentage of body weight indicates an improvement in condition.|After 56 days of treatment|All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.||total fat as apercentage of body weight||Standard Deviation|Mean
835941|NCT01284634|Secondary|Change From Baseline to the End of Treatment in Mean Abdominal Adiposity|Abdominal adiposity = ratio of total abdominal to total non-abdominal fat. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.|After 56 days of treatment|All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.||ratio||Standard Deviation|Mean
835942|NCT01284634|Secondary|Change From Baseline to the End of Treatment in Mean Total Fat|Total fat = total abdominal + total non-abdominal fat. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.|After 56 days of treatment|All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.||litres||Standard Deviation|Mean
835943|NCT01284634|Secondary|Change From Baseline to the End of Treatment in Mean Total Subcutaneous Fat|As measured by MRI/MRS scanning. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.|After 56 days of treatment|All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.||litres||Standard Deviation|Mean
835944|NCT01284634|Secondary|Change From Baseline to the End of Treatment in Mean Total Internal Fat|As measured by MRI/MRS scanning. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.|After 56 days of treatment|All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.||litres||Standard Deviation|Mean
835945|NCT01284634|Secondary|Change From Baseline to the End of Treatment in Mean Total Non-abdominal Fat|As measured by MRI/MRS scanning. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.|After 56 days of treatment|All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.||litres||Standard Deviation|Mean
835946|NCT01284634|Secondary|Change From Baseline to the End of Treatment in Mean Subcutaneous Non-abdominal Fat|As measured by MRI/MRS scanning. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.|After 56 days of treatment|All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.||litres||Standard Deviation|Mean
835947|NCT01284634|Secondary|Change From Baseline to the End of Treatment in Mean Internal Non-abdominal Fat|As measured by MRI/MRS scanning. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.|After 56 days of treatment|All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.||litres||Standard Deviation|Mean
835948|NCT01284634|Secondary|Change From Baseline to the End of Treatment in Mean Total Abdominal Fat|As measured by MRI/MRS scanning. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.|After 56 days of treatment|All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.||litres||Standard Deviation|Mean
835949|NCT01284634|Secondary|Change From Baseline to the End of Treatment in Mean Subcutaneous Abdominal Fat|As measured by MRI/MRS scanning. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.|After 56 days of treatment|All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.||litres||Standard Deviation|Mean
835950|NCT01284634|Secondary|Change From Baseline to the End of Treatment in Mean Visceral Abdominal Fat|As measured by MRI/MRS scanning. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.|After 56 days of treatment|All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.||litres||Standard Deviation|Mean
835951|NCT01284634|Secondary|Change From Baseline to the End of Treatment in Mean Total Skin-fold Thickness|Total skin fold thickness was based on the sum of the average values from the seven sites stated above. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.|After 56 days of treatment|All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.||mm||Standard Deviation|Mean
835952|NCT01284634|Secondary|Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Thigh)|Skin fold thickness measurements were the mean of three measurements per site calculated for each subject. If one or more measurements were missing for a site, then the mean was calculated over the available measurement(s) for that site. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.|After 56 days of treatment|All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.||mm||Standard Deviation|Mean
835953|NCT01284634|Secondary|Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Suprailiac)|Skin fold thickness measurements were the mean of three measurements per site calculated for each subject. If one or more measurements were missing for a site, then the mean was calculated over the available measurement(s) for that site. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.|After 56 days of treatment|All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.||mm||Standard Deviation|Mean
835954|NCT01284634|Secondary|Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Abdomen)|Skin fold thickness measurements were the mean of three measurements per site calculated for each subject. If one or more measurements were missing for a site, then the mean was calculated over the available measurement(s) for that site. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.|After 56 days of treatment|All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.||mm||Standard Deviation|Mean
835955|NCT01284634|Secondary|Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Subscapular)|Skin fold thickness measurements were the mean of three measurements per site calculated for each subject. If one or more measurements were missing for a site, then the mean was calculated over the available measurement(s) for that site. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.|After 56 days of treatment|All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.||mm||Standard Deviation|Mean
835956|NCT01284634|Secondary|Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Triceps)|Skin fold thickness measurements were the mean of three measurements per site calculated for each subject. If one or more measurements were missing for a site, then the mean was calculated over the available measurement(s) for that site. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.|After 56 days of treatment|All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.||mm||Standard Deviation|Mean
835957|NCT01284634|Secondary|Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Midaxillary)|Skin fold thickness measurements were the mean of three measurements per site calculated for each subject. If one or more measurements were missing for a site, then the mean was calculated over the available measurement(s) for that site. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.|After 56 days of treatment|All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.||mm||Standard Deviation|Mean
835958|NCT01284634|Secondary|Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Chest/Pectoral)|Skin fold thickness measurements were the mean of three measurements per site calculated for each subject. If one or more measurements were missing for a site, then the mean was calculated over the available measurement(s) for that site. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.|After 56 days of treatment|All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.||mm||Standard Deviation|Mean
835959|NCT01284634|Secondary|Change From Baseline to the End of Treatment in Mean Hip Measurement|Hip circumference was measured at baseline and the end of treatment. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.|After 56 days of treatment|All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.||cm||Standard Deviation|Mean
835960|NCT01284634|Secondary|Change From Baseline to the End of Treatment in Mean Waist Measurement|Waist circumference was measured at baseline and the end of treatment. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.|After 56 days of treatment|All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.||cm||Standard Deviation|Mean
835961|NCT01284634|Secondary|Change From Baseline to the End of Treatment in Mean Neck Measurement|The neck circumference was measured at baseline and the end of treatment. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.|After 56 days of treatment|All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.||cm||Standard Deviation|Mean
835962|NCT01284634|Secondary|Change From Baseline to the End of Treatment in Mean Waist-to-hip Ratio|The waist-to-hip ratio was calculated at baseline and the end of treatment. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.|After 56 days of treatment|All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.||ratio||Standard Deviation|Mean
835963|NCT01284634|Secondary|Change From Baseline to the End of Treatment in Mean Body Weight|Body weight (kg) was measured at baseline and the end of treatment. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.|After 56 days of treatment|All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.||kg||Standard Deviation|Mean
835964|NCT01284634|Secondary|Change From Baseline to the End of Treatment in Mean Body Mass Index (BMI)|Individual subject's BMIs were calculated by dividing mass (kg) by height (m2). A reduction from baseline (i.e. a negative value) indicates an improvement in condition.|After 56 days of treatment|All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.||kg/m2||Standard Deviation|Mean
835965|NCT01284634|Secondary|Change From Baseline to the End of Treatment in Mean Fasting Plasma Glucose Levels|A fasting blood sample was obtained for the measurement of fasting plasma glucose. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.|After 56 days of treatment|All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.||mmol/l||Standard Deviation|Mean
835966|NCT01284634|Secondary|Change From Baseline to the End of Treatment in Mean Serum Triglyceride Levels|A fasting blood sample was obtained for the measurement of serum triglycerides. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.|After 56 days of treatment|All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.||mmol/l||Standard Deviation|Mean
835967|NCT01284634|Secondary|Change From Baseline to the End of Treatment it the Mean Serum HDL:LDL Cholesterol Ratio|A fasting blood sample was obtained for the measurement of HDL-C and LDL-C, allowing the HDL:LDL cholesterol ratio to be calculated. An increase from baseline (i.e. a positive value) indicates an improvement in condition.|After 56 days of treatment|All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.||ratio||Standard Deviation|Mean
835968|NCT01284634|Secondary|Change From Baseline to the End of Treatment in Mean Serum Low Density Lipoprotein (LDL)-Cholesterol(C) Levels|A fasting blood sample was obtained for the measurement of LDL-C. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.|After 56 days of treatment|All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.||mmol/l||Standard Deviation|Mean
835969|NCT01284634|Secondary|Change From Baseline to the End of Treatment in Mean Serum High Density Lipoprotein (HDL)-Cholesterol(C) Levels|A fasting blood sample was obtained for the measurement of HDL-C. An increase from baseline (i.e. a positive value) indicates an improvement in condition.|After 56 days of treatment|All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.||mmol/l||Standard Deviation|Mean
835970|NCT01284634|Secondary|Change From Baseline to the End of Treatment it Mean Serum Total Cholesterol Levels|A fasting blood sample was taken for the measurement of serum total cholesterol. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.|After 56 days of treatment|All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.||mmol/l||Standard Deviation|Mean
835971|NCT01284634|Primary|Change From Baseline to the End of Treatment in Mean % Liver Triglyceride Levels|Liver triglyceride levels (%) were measured by MRI/MRS scanning and the change from baseline to end of treatment in group mean levels were investigated. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.|After 56 days of treatment|All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.||percentage of liver triglycerides||Standard Deviation|Mean
835972|NCT01284959|Secondary|Assessment of Cognitive Functioning-3|"CNT(Computerized Neuro-Cognitive Function Test System); The tests included Wisconsin Card-Sorting Test (WCST). All of the assessments except the CNT were conducted immediately prior to administration of the medication and at 2 (for risperidone and placebo) or 24 h (for paliperidone ER) after the first and third administrations of the study medications.
Minimum of Wisconsin card sorting test-Category completed is 0, Maximum is 6, the lower number is worse outcome.
Minimum of Wisconsin card sorting test-Perseverative response and Trials to complete is 0, Maximum is 128, the lower number is worse outcome.
Minimum of Wisconsin card sorting test-Trials to complete first category trials is 0, Maximum is 128 and minimum of Wisconsin card sorting test-Perseverative error is 0, Maximum is 128, the higher number is worse outcome.
The score ranges are for subscale score. This outcome measure is reporting a change between baseline and 50hr after th"|baseline and 50hr after third medication|||trials||Standard Deviation|Mean
835973|NCT01284959|Secondary|Assessment of Cognitive Functioning-2|"CNT(Computerized Neuro-Cognitive Function Test System); The tests included the Stroop test, Trail-Making Test B (TMT B). All of the assessments except the CNT were conducted immediately prior to administration of the medication and at 2 (for risperidone and placebo) or 24 h (for paliperidone ER) after the first and third administrations of the study medications Minimum of Stroop test is 0, no maximum limit, the higher number is worse outcome.
Minimum of Trail making test B is 0 and no maximum limit, the higher number is worse outcome.
The score ranges are for subscale score. This outcome measure is reporting a change between baseline and 50hr after third medication."|baseline and 50hr after third medication|||milliseconds||Standard Deviation|Mean
835974|NCT01284959|Secondary|Symptoms Assessment by Objective Rating Scales|SANS(Scale for the Assessment of Negative Symptoms), NIDSS(Neuroleptic induced Deficit Syndrome Scale) Minimum of NIDSS is -3, maximum of NIDSS is +3. '+' is better outcome, '-' is worse outcome. Minimum of SNAS-Global score is 0, Maximum of SNAS-Global score is 5 The higher number is worse outcome. The zeros are measured and Calcuated value. The score ranges are for subscale score. This outcome measure is reporting a change between baseline and 50hr after third medication.|baseline and 50hr after third medication|||units on a scale||Standard Deviation|Mean
835975|NCT01284959|Secondary|Assessment of Cognitive Functioning-1|"CNT(Computerized Neuro-Cognitive Function Test System); The tests included a word fluency test. All of the assessments except the CNT were conducted immediately prior to administration of the medication and at 2 (for risperidone and placebo) or 24 h (for paliperidone ER) after the first and third administrations of the study medications.
Minimum of Wisconsin card sorting test-Category completed is 0, Maximum is 6, the lower number is worse outcome.
Minimum of Wisconsin card sorting test-Perseverative response and Trials to complete is 0, Maximum is 128, the lower number is worse outcome.
Minimum of Wisconsin card sorting test-Perseverative error is 0, Maximum is 128, the higher number is worse outcome.
Minimum of Word-fluency test is 0 and no maximum value, the higher number is better outcome.
The score ranges are for subscale score. This outcome measure is reporting a change between baseline and 50hr after third medication."|baseline and 50hr after third medication|||scores on a scale||Standard Deviation|Mean
835976|NCT01284959|Secondary|Assessment of Adverse Events by Objective Rating Scales and Self Report Scales|DIEPSS(Drug-Induced Extrapyramidal Symptoms Scale), VAS(Visual analog scale);mental sedation (alert-drowsy, muzzy-clear headed, mentally slow-quick witted, attentive-dreamy), physical sedation (strong-feeble, well coordinated-clumsy, lethargic-energetic, incompetent-proficient), tranquilization (calm-excited, contented-discontented, troubled-tranquil, tense-relaxed), and other types of feelings (happy-sad, antagonistic-amicable, interested-bored, withdrawn-gregarious) Minimum of VAS is 0, Maximum is 10 Minimum of DIEPSS is 0, Maximum is 4 The higher number is worse outcome. The score ranges are for subscale score. This outcome measure is reporting a change between baseline and 50hr after third medication.|baseline and 50hr after third medication|||units on a scale||Standard Deviation|Mean
835977|NCT01284959|Secondary|Assessment of Adverse Events by Objective Rating Scales and Self Report Scales|"DIEPSS(Drug-Induced Extrapyramidal Symptoms Scale), VAS(Visual analog scale);mental sedation (alert–drowsy, muzzy–clear headed, mentally slow–quick witted, attentive–dreamy), physical sedation (strong–feeble, well coordinated–clumsy, lethargic–energetic, incompetent–proficient), tranquilization (calm–excited, contented–discontented, troubled–tranquil, tense–relaxed), and other types of feelings (happy–sad, antagonistic–amicable, interested–bored, withdrawn–gregarious) Minimum of VAS(Mental sedation score,Physical sedation score,Total score) is 0, Maximum is 10.
VAS-total score is average of all subscale scores. Minimum of DIEPSS is 0, Maximum is 4. The higher number is worse outcome. The score ranges are for subscale score. This outcome measure is reporting a change between baseline and 2hr after third medication."|baseline and 2hr after third medication|||units on a scale||Standard Deviation|Mean
835978|NCT01284959|Primary|Assessment of Negative Symptoms and Neuroleptic Induced Deficit Syndromes by Objective Rating Scales|"SANS(Scale for the Assessment of Negative Symptoms), NIDSS(Neuroleptic induced Deficit Syndrome Scale) In NIDSS, the average of number 1 to 5 is blunted affect, the average of number 16 to 20 is avolition, the average of number 6 to 15 is cognition, the average of all score is total.
Minimum of NIDSS(avolition, blunted affect, cognition, total) is -3, maximum is +3.(subscale score and total) '+' is better outcome, '-' is worse outcome. Minimum of SANS-Global score for alogia and blunted affect is 0, Maximum of SANS-Global score for alogia and blunted affect is 5 The higher number is worse outcome. The zeros are measured and Calcuated value This outcome measure is reporting a change between baseline and 2hr after third medication."|baseline and 2hr after third medication|||units on a scale||Standard Deviation|Mean
835979|NCT01285024|Secondary|Total Hemoglobin Level Change|Total hemoglobin level change from preop to postoperative discharge.|day of surgery - 1 week postoperative|||g/dL||Standard Deviation|Mean
835980|NCT01285024|Primary|Transfusion Requirement|Measure Title: Units of transfusion required|intraoperative - 1 week postoperative|||units||Standard Deviation|Mean
835981|NCT01285050|Primary|HCV RNA|HCV RNA determined by reverse transcription polymerase chain reaction and measured as log IU/ml 48 hours after a single dose of peginterferon alfa 2b 1.5 μg/kg.|48 hours after interferon administration|||log IU/ml||Inter-Quartile Range|Median
835982|NCT01285076|Secondary|Self-reported Barrier Questionnaire|The self-report barrier questionnaire contains 4 items: difficulty filling prescriptions, unsure about physician instructions, unable to follow plan for diabetes, and bothered by adverse effects during the prior month.|30 days (during the 30-day period prior to the encounter visit)|All enrolled participants.||Participants|||Number
835983|NCT01285076|Secondary|Fear of Weight Gain Questionnaire|Participants completed a questionnaire regarding their fear of wt gain during the previous year. The questionnaire contained 3 parts: worried about wt gain, worried that diabetic treatment causes wt gain (worried diab tx and wt gain), and worried about not being able to stabilize wt (worried not stabilize wt).|1 year (during the 12-month period prior to the encounter visit)|The population analyzed only includes participants with available data.||Percentage of participants|||Number
835984|NCT01285076|Secondary|Experience of Weight Gain Questionnaire|Participants completed a questionnaire regarding weight (wt) gain during the previous year (measured in kilograms[kg]). The questionnaire contained 4 parts: wt gain, subjective severity of wt gain, bothered by wt gain, and difficulty maintaining wt. Percentages presented below are rounded.|1 year (during the 12-month period prior to the encounter visit)|The population analyzed includes only participants with available data.||Percentage of participants|||Number
835985|NCT01285076|Secondary|Score on the Worry Scale of Hypoglycemia Fear Survey (HFS) II|This questionnaire measures a diabetic participant’s fear of hypoglycemia. Items were answered using a 5-point Likert scale; range: 1 (never) to 5 (very often). Total possible scores ranged from 18 (least) to 90 (most).|6 months (during the 6-month period prior to the encounter visit)|The population analyzed includes only participants with available data.||Score on a scale||Standard Deviation|Mean
835986|NCT01285076|Secondary|Experience of Low Blood Sugar (Hypoglycemia) Questionnaire|The experience of low blood sugar questionnaire was developed by the Sponsor to measure the participant's experience of hypoglycemia during the previous 6 months. The questionnaire contains 6 items answered by yes/no or by using a 5-point Likert scale.|6 months (during the 6-month period prior to the encounter visit)|All enrolled participants.||Participants|||Number
835987|NCT01285076|Secondary|Number of Adherence Days on the Self-reported Adherence Questionnaire|The self-report adherence questionnaire contains the following items: diabetic diet, exercise, and no missed medication doses during the past week. Total possible score ranges from 0 days (complete non-adherence) to 7 days (complete adherence).|7 days (during the 7-day period prior to the encounter visit)|All enrolled participants.||Days||Standard Deviation|Mean
835988|NCT01285076|Secondary|Score on the Treatment Satisfaction Questionnaire for Medication (TSQM)|TSQM is a treatment satisfaction questionnaire. The questionnaire consisted of the following dimensions: side effects (4 items), effectiveness (3 items), convenience (3 items) and global satisfaction scale (3 items). Each dimension was measured as a score on a scale. Total possible score ranges from 0 to 100 with a lower score representing a better quality of life.|1 day (the day of the encounter visit)|All enrolled participants.||Score on a scale||Standard Deviation|Mean
835989|NCT01285076|Secondary|Score on the Quality of Life (EQ-5D) Questionnaire|The EQ-5D is a standardised instrument for use as a measure of general health outcome. The EQ-5D contains 5 items to be answered using a 3-point Likert scale plus a Visual Analog Scale (VAS). The EQ-5D covers the following dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Total possible score ranges from 0 (worst) to 100 (best).|1 day (the day of the encounter visit)|The population analyzed includes only participants with available data.||Score on a scale||Standard Deviation|Mean
835990|NCT01285076|Primary|Number of Participants With Hypoglycemic Episodes|Participants self-reported hypoglycemic (low blood sugar) episodes.|6 months|All enrolled participants.||participants|||Number
835991|NCT01285076|Primary|Number of Participants Achieving Hemoglobin A1C (HbA1C) <7%|HbA1c is measured as a percent.|6 months|The population analyzed includes only participants with available data.||participants|||Number
836233|NCT01286558|Secondary|Seated SBP Response Rate at Trough|SBP response rate: The rate of patients who achieved an adequate response in seated SBP at trough (<140 mmHg and/or reduction from reference baseline >=20 mmHg) after the 8-week double-blind period At trough: 24-hour post-dosing|8 weeks|FAS||percentage of participants|||Number
836090|NCT01285401|Secondary|Mean Number of Combined Unique Active (CUA) Lesions Per Subject Per Scan at Week 48|CUA lesions was defined as new T1 (Gd enhancing) lesions, new Relaxation time 2 (T2) lesions, or enlarging T2 lesions.|48 Weeks|ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.||lesions per subject per scan||Standard Deviation|Mean
836091|NCT01285401|Secondary|Cumulative Number of Relaxation Time 1 (T1) Gadolinium Enhancing Lesions at Week 48||48 Weeks|"ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP. Here N signifies number of subject analyzed for respective outcome measure."||lesions per subject per scan||Standard Deviation|Mean
836065|NCT01285323|Secondary|Participants With a Positive Anti-Reslizumab Antibody Status During Study|Counts of participants with a positive anti-drug antibody (ADA) response during treatment is offered for the experimental treatment arm. Blood samples were collected for determination of ADAs before study drug infusion.|Baseline visit (prior to reslizumab exposure), Weeks 16, 32, 48 and 52|Safety analysis set||participants|||Number
836066|NCT01285323|Secondary|Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Vital Signs Values|"Data represents participants with potentially clinically significant (PCS) vital sign values.
Significance criteria
Sitting pulse (high): >100 and increase of >= 30 beats/minute
Sitting systolic blood pressure (low): <90 and decrease of >= 30 mmHg
Sitting systolic blood pressure (high): >160 and increase of >= 30 mmHg
Sitting diastolic blood pressure (low): <50 and decrease of >=12 mmHg (if 12-17 years old: <55 and decrease of >=12 mmHg 0
Sitting diastolic blood pressure (high): >100 and increase of >=12 mmHg
Respiratory rate (low): <6 breaths/minute
Respiratory rate (high): >24 and increase of >=10 breaths/minute
Body temperature (low): <35.8° Celsius
Body temperature (high): >=38.1 and increase of >=1.1° Celsius"|Week 4 to Week 52|Safety analysis set including participants who contributed data to the analysis||participants|||Number
836067|NCT01285323|Secondary|Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Abnormal Lab Values|"Data represents participants with potentially clinically significant (PCS) abnormal serum chemistry, hematology (except for eosinophil values), and urinalysis values.
Significance criteria:
Blood urea nitrogen: >=10.71 mmol/L
Creatinine: >=177 μmol/L
Urate: M>=625, F>=506 μmol/L
Aspartate aminotransferase (AST): >=3*upper limit of normal (ULN)
Alanine aminotransferase (ALT): >=3*ULN
GGT = gamma-glutamyl transpeptidase: >= 3*ULN
Total bilirubin: >=34.2 μmol/L
White blood cells (low): <=3.0*10^9/L
White blood cells (high): >=20*10^9/L
Hemoglobin (age >=18 years): M<=115, F<=95 g/dL
Hematocrit (age >=18 years): M<0.37, F<0.32 L/L
Eosinophils/leukocytes: >=10.0%
Platelets: <=75*10^9/L
Neutrophils: <=1.0*10^9/L
Urinalysis: blood, ketones, glucose, and protein: >=2 unit increase from baseline"|Week 4 to Week 52|Safety analysis set, including participants who contributed to the analysis||participants|||Number
836068|NCT01285323|Primary|Frequency of Each of the Two Criteria for Clinical Asthma Exacerbations (CAEs)|"An exacerbation event was considered a CAE if the patient met either or both of the criteria listed below and this was corroborated with at least 1 other measurement to indicate the worsening of clinical signs and symptoms of asthma:
use of systemic, or an increase in the use of inhaled, corticosteroid treatment for 3 or more days; or an increased 2 or more fold for at least 3 or more days for patient's already on corticosteroids.
asthma-related emergency treatment, such as an unscheduled visit to the physician’s office or emergency room for nebulizer treatment or other urgent treatment to prevent worsening of asthma symptoms, or an asthma-related hospitalization CAEs were adjudicated by committee to assure consistency.
Adjusted CAE rate and confidence intervals for the two criteria were based on Negative Binomial regression model adjusted for stratification factors.
Results are offered as adjusted means."|Day 1 to Month 12|Randomized set includes all patients who were randomly assigned to a treatment group at enrollment, regardless of whether or not a patient took any study drug.||CAEs in 52 weeks||95% Confidence Interval|Mean
836069|NCT01285323|Secondary|Participants With Treatment-Emergent Adverse Events TEAE)|An adverse event (AE) was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an inability to carry out usual activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.|Safety analysis set||participants|||Number
836070|NCT01285323|Secondary|Change From Baseline in Blood Eosinophil Count Over 16 Weeks and 52 Weeks Using Mixed Model for Repeated Measures|"The blood eosinophil counts were measured using a standard complete blood count (CBC) with differential blood test. Results of all differential blood tests conducted after randomization were blinded.
The during treatment average eosinophil count was estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements. The 'over 16 weeks' value used data from Weeks 4, 8, 12 and 16. The 'over 52 weeks' value used all the during study time points listed in the Time Frame field.
Negative change from baseline values correlate to reduced asthma severity."|Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 or early withdrawal|Randomized set including patients who contributed at least once to the analysis.||10^9 blood eosinophil/L||Standard Error|Least Squares Mean
836142|NCT01285518|Primary|Number of Participants With Vital Signs Abnormalities|Criteria for vital signs abnormalities: supine systolic blood pressure (SBP) <90 millimeter of mercury (mmHg), supine diastolic BP (DBP) <50 mmHg, supine pulse rate <40 beats per minute (bpm). Maximum increase or decrease from baseline in supine SBP >=30 mmHg and maximum increase or decrease from baseline in supine DBP >=20 mmHg.|Day 1 up to Day 15|Safety population included all participants who received at least 1 dose of study medication.||participants|||Number
836071|NCT01285323|Secondary|Change From Baseline in Short-Acting Beta-Agonist (SABA) Use Over 16 Weeks Using Mixed Model for Repeated Measures|"SABA are used for quick relief of asthma symptoms. To measure SABA use, at each clinical visit patients were asked to recall their usage of SABA therapy within the last 3 days of the scheduled visit. If usage was confirmed, the number of puffs used was recorded. For the purpose of summaries, an average daily usage was evaluated by dividing the total number of puffs recorded over 3 days by 3.
The during treatment (Weeks 4, 8, 12 and 16) average SABA use was estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.
Negative change from baseline scores indicate improvement in asthma control."|Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16|Randomized set including patients who contributed at least once to the analysis.||SABA puffs per day||Standard Error|Least Squares Mean
836072|NCT01285323|Secondary|Change From Baseline in Asthma Symptom Utility Index (ASUI) Over 16 Weeks Using Mixed Model for Repeated Measures|"The ASUI is an 11-item instrument designed to assess the frequency and severity of asthma symptoms and side effects, weighted by patient preferences (Revicki et al 1998). ASUI is a utility score that ranges from 0 to 1, with higher values indicating better asthma control; info obtained from questionnaire about asthma symptoms.
The during treatment (Weeks 4, 8, 12 and 16) average ASUI was estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.
Positive change from baseline values indicate improvement in asthma symptoms. Information was obtained from questionnaire about asthma symptoms."|Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16|Randomized set, including participants who contributed at least once to the analysis.||units on a scale||Standard Error|Least Squares Mean
836073|NCT01285323|Secondary|Kaplan-Meier Estimates for Time to First Clinical Asthma Exacerbation (CAE)|"An exacerbation event was considered a CAE if the patient met either or both of the criteria listed below and this was corroborated with at least 1 other measurement to indicate the worsening of clinical signs and symptoms of asthma:
use of systemic, or an increase in the use of inhaled, corticosteroid treatment for 3 or more days; or an increased 2 or more fold for at least 3 or more days for patient's already on corticosteroids.
asthma-related emergency treatment, such as an unscheduled visit to the physician's office or emergency room for nebulizer treatment or other urgent treatment to prevent worsening of asthma symptoms, or an asthma-related hospitalization.
CAEs were adjudicated by committee to assure consistency. The distributions were compared by a log rank test stratified by baseline usage of oral corticosteroid (yes or no) and geographical region (US or other)."|Day 1 to Day 526 (longest treatment time plus 2 weeks)|Randomized set||weeks||95% Confidence Interval|Median
836074|NCT01285323|Secondary|Change From Baseline in Asthma Control Questionnaire (ACQ) Over 16 Weeks Using Mixed Model for Repeated Measures|"The ACQ is a 7-item instrument that measures asthma control (Juniper et al 1999). Six questions are self-assessments; the seventh item, completed by a member of the study staff, is the result of the patient's FEV1 measurement. Each item has 7 possible answers on a scale of 0 to 6, and the total score is the mean of all responses (the total scale is therefore 0-6). A higher score is an indication of poorer asthma control. The during treatment (Weeks 4, 8, 12 and 16) average ACQ was estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.
Negative change from baseline scores indicate improvement in asthma control."|Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16|Randomized set, including participants who contributed at least once to the analysis.||units on a scale||Standard Error|Least Squares Mean
836075|NCT01285323|Secondary|Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) to Week 16|"The AQLQ is a 32-item instrument administered as a self-assessment (Juniper et al 1992). The questionnaire is divided into 4 domains: activity limitation, symptoms, emotional function, and environmental stimuli. Patients were asked to recall their experiences during the last 2 weeks and to respond to each question on a 7-point scale (1=severe impairment, 7=no impairment). The overall AQLQ score is the mean of all 32 responses. Five of the activity questions were patient-specific, which means that each patient identified and scored 5 activities in which the patient was limited by asthma; these 5 activities were identified at the first visit and retained for all subsequent follow-up visits.
Positive change from baseline scores indicate improvement in quality of life."|Day 1 (baseline, pre-dose), Week 16|Randomized set of participants with assessments at each timepoint.||units on a scale||Standard Error|Least Squares Mean
836076|NCT01285323|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Over 16 Weeks Using Mixed Model for Repeated Measures|"FEV1 is a standard measurement of air movement in the lungs of patients with asthma obtained from pulmonary function tests. It is the volume of air expired in the first second of a forced expiration using a spirometer. During study (Weeks 4, 8, 12 and 16) average value used a mixed effect model for repeated measures (MMRM) with treatment group, visit, treatment and visit interaction, and stratification factors as fixed effects and participant as a random effect. Covariates for baseline values were also included in the model; for pulmonary function test analyses, covariates for height and sex were included as well.
Positive change from baseline scores indicate improvement in asthma control."|Day 1 (baseline, pre-dose), Weeks 4, 8, 12 and 16|Randomized set includes all patients who were randomly assigned to a treatment group at enrollment, regardless of whether or not a patient took any study drug. Includes participants who contributed at least once to the analysis.||liters||Standard Error|Least Squares Mean
836077|NCT01285323|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) At Week 16|"FEV1 is a standard measurement of air movement in the lungs of patients with asthma obtained from pulmonary function tests. It is the volume of air expired in the first second of a forced expiration using a spirometer.
Positive change from baseline scores indicate improvement in asthma control."|Day 1 (baseline, pre-dose), Week 16|Randomized set includes all patients who were randomly assigned to a treatment group at enrollment, regardless of whether or not a patient took any study drug. Number analyzed reflects participants with both baseline and Week 16 assessments.||liters||Standard Error|Least Squares Mean
836194|NCT01286129|Secondary|Change in Nasal Lavage Eosinophils After Allergen Challenge|Change in nasal lavage eosinophil percentages in allergic asthmatic and allergic non asthmatic at baseline and at 7h post first and last challenge|At 7 hours post first and last challenge compared to baseline|||percentage of nasal lavage eosinophils||Standard Error|Mean
836078|NCT01285323|Primary|Frequency of Clinical Asthma Exacerbations (CAEs) During 12 Months of Treatment|"An exacerbation event was considered a CAE if the patient met either or both of the criteria listed below and this was corroborated with at least 1 other measurement to indicate the worsening of clinical signs and symptoms of asthma:
use of systemic, or an increase in the use of inhaled, corticosteroid treatment for 3 or more days; or an increased 2 or more fold for at least 3 or more days for patient's already on corticosteroids.
asthma-related emergency treatment, such as an unscheduled visit to the physician’s office or emergency room for nebulizer treatment or other urgent treatment to prevent worsening of asthma symptoms, or an asthma-related hospitalization.
CAEs were adjudicated by committee to assure consistency. Adjusted CAE rate and confidence intervals were based on Negative Binomial regression model adjusted for stratification factors.
Results are offered as adjusted means."|Day 1 to Month 12|Randomized set includes all patients who were randomly assigned to a treatment group at enrollment, regardless of whether or not a patient took any study drug.||CAEs in 52 weeks||95% Confidence Interval|Mean
836079|NCT01285401|Post-Hoc|Percentage of Subjects With Disease Activity Free Status (Alternate Definition) at Week 48|Disease activity free (DAF) status was defined as absence of any of the clinical and imaging parameters related to the assessment of disease activity; no relapses, no confirmed expanded disability status scale (EDSS) progression and no new gadolinium (Gd)-enhancing or relaxation time 2 (T2) magnetic resonance imaging (MRI) lesions. Confirmed EDSS progression was defined as an EDSS progression confirmed after 24 weeks.|Week 48|ITT set included all randomized subjects who received at least 1 dose of the IMP.||percentage of subjects|||Number
836080|NCT01285401|Secondary|Mean Change From Baseline in the Total Volume of T1 Hypo Intense Lesions at Week 48||Baseline, 48 Weeks|ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.||millimeter^3 (mm^3)||Standard Deviation|Mean
836081|NCT01285401|Secondary|Percentage of Subjects Treated With Glucocorticoids Due to Relapses|Relapse was defined as neurological abnormality, either newly appearing or re-appearing, with abnormality specified by both as neurological abnormality separated by at least 30 days from onset of a preceding MS attack and Neurological abnormality lasting for at least 24 hours, absence of fever or known infection greater than 37.5 degree centigrade /99.5 degree fahrenheit , objective neurological impairment, correlating with the subject’s reported symptoms, defined as either increase in at least one of the functional systems of the EDSS or increase of the total EDSS score and occurrence of paraesthesia, fatigue, mental symptoms, and/or vegetative symptoms without any additional symptom will not be classified as an MS attack.|Baseline upto 48 weeks|ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.||percentage of subjects|||Number
836082|NCT01285401|Secondary|Total Number of Reported Relapses at All Time Points up to 48 Weeks|Relapse was defined as neurological abnormality, either newly appearing or re-appearing, with abnormality specified by both as neurological abnormality separated by at least 30 days from onset of a preceding MS attack and Neurological abnormality lasting for at least 24 hours, absence of fever or known infection greater than 37.5 degree centigrade /99.5 degree fahrenheit , objective neurological impairment, correlating with the subject’s reported symptoms, defined as either increase in at least one of the functional systems of the EDSS or increase of the total EDSS score and occurrence of paraesthesia, fatigue, mental symptoms, and/or vegetative symptoms without any additional symptom will not be classified as an MS attack.|48 weeks|ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.||number of relapse per subject||Standard Deviation|Mean
836083|NCT01285401|Secondary|Annualized Relapse Rate at Week 48|Relapse was defined as neurological abnormality, either newly appearing or re-appearing, with abnormality specified by both as neurological abnormality separated by at least 30 days from onset of a preceding MS attack and Neurological abnormality lasting for at least 24 hours, absence of fever or known infection greater than 37.5 degree centigrade /99.5 degree fahrenheit , objective neurological impairment, correlating with the subject’s reported symptoms, defined as either increase in at least one of the functional systems of the EDSS or increase of the total EDSS score and occurrence of paraesthesia, fatigue, mental symptoms, and/or vegetative symptoms without any additional symptom will not be classified as an MS attack.|48 weeks|ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.||relapse per year||Standard Deviation|Mean
836084|NCT01285401|Secondary|Number of Subjects With Relapse|Relapse was defined as neurological abnormality, either newly appearing or re-appearing, with abnormality specified by both as neurological abnormality separated by at least 30 days from onset of a preceding MS attack and Neurological abnormality lasting for at least 24 hours, absence of fever or known infection greater than 37.5 degree centigrade /99.5 degree fahrenheit , objective neurological impairment, correlating with the subject’s reported symptoms, defined as either increase in at least one of the functional systems of the EDSS or increase of the total EDSS score and occurrence of paraesthesia, fatigue, mental symptoms, and/or vegetative symptoms without any additional symptom will not be classified as an MS attack.|Baseline upto 48 weeks|ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.||subjects|||Number
836085|NCT01285401|Secondary|Percentage of New T1 Hypointense Lesions (Black Holes) at Week 48 Within the Subgroup of New or Enlarging Non-enhancing T2 Lesions||48 Weeks|ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP. Here “N” signifies number of subjects analyzed for respective outcome measure (here in the subgroup of subjects having new or enlarging T2 lesions).||percentage of new T1 hypointense lesions||Standard Deviation|Mean
836086|NCT01285401|Secondary|Percentage of Subjects Free From New T1 Hypointense Lesions (Black Holes) at Week 48||48 Weeks|ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.||percentage of subjects|||Number
836087|NCT01285401|Secondary|Percentage of Subjects Free From T1 Gadolinium Enhancing Lesions at Week 48||48 Weeks|ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.||percentage of subjects|||Number
836088|NCT01285401|Secondary|Mean Change From Baseline in the Total Volume of T2 Lesions at Week 48 (T2 Burden of Disease)||Baseline, 48 Weeks|"ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP. Here N signifies number of subjects analyzed for respective outcome measure."||millimeter^3 (mm^3)||Standard Deviation|Mean
836089|NCT01285401|Secondary|Cumulative Number of New Combined Unique Active (CUA) Lesions at Week 48|CUA lesions was defined as new T1 (Gd enhancing) lesions, new T2 lesions, or enlarging T2 lesions.|48 Weeks|ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.||lesions per subject per scan||Standard Deviation|Mean
836092|NCT01285401|Secondary|Number od Subjects With Confirmed EDSS Progression|EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. A confirmed EDSS progression was defined EDSS greater than or equal to 1.0 point confirmed during a visit performed 6 months later. An EDSS progression was defined as an increase of the EDSS score of at least 1.0 point compared to baseline (SD1) for subjects with a baseline EDSS ≤ 4.0. For subjects with an EDSS score of 0 at baseline (SD1), EDSS progression was defined as an increase of at least 1.5 points. A confirmed EDSS progression was defined as an EDSS progression confirmed after 24 weeks.|Baseline upto 48 Weeks|ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.||subjects|||Number
836093|NCT01285401|Secondary|Percentage of Subjects Free From Any Expanded Disability Status Scale (EDSS) Progression at Week 48|EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. A confirmed EDSS progression was defined EDSS greater than or equal to 1.0 point confirmed during a visit performed 6 months later. An EDSS progression was defined as an increase of the EDSS score of at least 1.0 point compared to baseline (SD1) for subjects with a baseline EDSS ≤ 4.0. For subjects with an EDSS score of 0 at baseline (SD1), EDSS progression was defined as an increase of at least 1.5 points. A confirmed EDSS progression was defined as an EDSS progression confirmed after 24 weeks.|Week 48|ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.||percentage of subjects|||Number
836094|NCT01285401|Secondary|Percentage of Relapse-free Subjects at Week 48|A relapse was defined as the development of new or the exacerbation of existing neurological symptoms or signs, in the absence of fever, lasting for 24 hours and with a previous period for more than 30 days with a stable or an improving condition.|Week 48|ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.||percentage of subjects|||Number
836095|NCT01285401|Primary|Percentage of Subjects With Disease Activity Free Status up to Week 48|Disease activity free status was defined as absence of any of the clinical and imaging parameters related to the assessment of disease activity; no relapses, no expanded disability status scale (EDSS) progression and no new gadolinium (Gd)-enhancing or relaxation time 2 (T2) magnetic resonance imaging (MRI) lesions.|Up to Week 48|ITT set included all randomized subjects who received at least 1 dose of the IMP.||percentage of subjects|||Number
836096|NCT01285427|Primary|SeCore® Kit, DR Group Kit (DRB345 Loci), Primary Analysis of Concordance Rate Clopper-Pearson CI)|The concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method|10 weeks|||percentage of concordant alleles|Participants|90% Confidence Interval|Number
836097|NCT01285427|Primary|SeCore® Kit, DR Group Kit (DRB1 Locus), Primary Analysis of Concordance Rate (CI)|The concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method|10 weeks|||percentage of concordant alleles|Participants|90% Confidence Interval|Number
836098|NCT01285427|Primary|SeCore® Kit, DRB1 Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI)|The concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method|10 weeks|||percentage of concordant alleles|Participants|90% Confidence Interval|Number
836099|NCT01285427|Primary|SeCore® Kit, DQB1 Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI)|the concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method|10 weeks|||percentage of concordant alleles|Participants|90% Confidence Interval|Number
836100|NCT01285427|Primary|SeCore® Kit, DPB1 Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI)|SeCore® DPB1 Locus, the concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method|10 weeks|||percentage of concordant alleles|Participants|90% Confidence Interval|Number
836101|NCT01285427|Primary|SeCore® Kit, C Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI)|SeCore® Kit, C Locus, the concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method.|10 weeks|||percentage of concordant alleles|Participants|90% Confidence Interval|Number
836102|NCT01285427|Primary|SeCore® Kit, B Locus (Single Amp), Primary Analysis of Concordance Rate (Clopper-Pearson CI)|SeCore® Kit, B Locus (Single Amp), The concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method.|10 weeks|||percentage of concordant alleles|Participants|90% Confidence Interval|Number
836103|NCT01285427|Primary|SeCore® Kit, A Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI)|SeCore Kit, A Locus,the concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method|10 weeks|||percentage of concordant alleles|Participants|90% Confidence Interval|Number
836104|NCT01285427|Primary|All SeCore® Kits,Primary Analysis of Concordance Rate (Clopper-Pearson CI)|All kits,the concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method|10 weeks|||percentage of concordant alleles|Participants|90% Confidence Interval|Number
836105|NCT01285492|Secondary|Change in Pre-dose Forced Vital Capacity (FVC) From Baseline|Pre-dose FVC is defined as the average of the measurements at 45 and 15 min pre-dose. Baseline is defined as the pre-dose FVC value on Day 1 (Week 1).|Weeks 3, 6, 12, 24, 36, 52|Full Analysis Set (FAS) included all randomized patients who received at least one dose of study drug.||Litres||Standard Deviation|Mean
836106|NCT01285492|Secondary|Change in Pre-dose Forced Expiratory Volume in One Second (FEV1) From Baseline|Pre-dose FEV1 is defined as the average of the measurements at 45 and 15 min pre-dose. Baseline is defined as the pre-dose FEV1 value on Day 1 (Week 1).|Weeks 3, 6, 12, 24, 36, 52|Full Analysis Set (FAS) included all randomized patients who received at least one dose of study drug.||Litres||Standard Deviation|Mean
836107|NCT01285492|Secondary|Number of Patients With Newly Occurring or Worsening Clinically Notable Fridericia’s QTc Values at Any Time-point Over the Whole Treatment Period|Clinically notable change from baseline was an increase from baseline of 30 or greater milliseconds (ms).|52 weeks|The safety set included all patients who received at least one dose of study drug.||Participants|||Number
836234|NCT01286558|Secondary|Seated DBP Response Rate at Trough|DBP response rate: The rate of patients who achieved an adequate response in seated DBP at trough (<90 mmHg and/or reduction from reference baseline >=10 mmHg) after the 8-week double-blind period At trough: 24-hour post-dosing|8 weeks|FAS||percentage of participants|||Number
836108|NCT01285492|Secondary|Number of Patients With Newly Occurring or Worsening Clinically Notable Vital Signs Values at Any Time-point Over the Whole Treatment Period|Clinically notable vital sign values were: pulse rate - low, <40 bpm or <=50 bpm and decrease from baseline >=15bpm; pulse rate high, >130 bpm or >=120bpm and increase from baseline >=15 bpm. Systolic blood pressure - low, <75 mmHg or <=90 mmHg and decrease from baseline >=20 mmHg; high, >200 mmHg or >=180 mmHg and increase from baseline >=20 mmHg. Diastolic blood pressure - low, <40 mmHg or <=50 mmHg and decrease from baseline >=15 mmHg; high, >115 mmHg or >=105 mmHg and increase from baseline >=15 mmHg.|52 weeks|The safety set included all patients who received at least one dose of study drug.||Participants|||Number
836109|NCT01285492|Secondary|Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Time-point Over the Treatment Period|Clinically notable biochemistry values were: total protein - <4.0 g/dL or >9.5 g/dL; albumin <2.5 g/dL; bilirubin (total) >1.9 mg/dL; BUN >27 mg/dL; creatinine >1.99 mg/dL; AST >3 x ULN U/L; ALT >3 x ULN U/L; ALP >3 x ULN U/L; y-GTP >3 x ULN U/L; sodium <125 mEq/L or >160 mEq/L; potassium <3.0 mEq/L or >6.0 mEq/L; glucose <51.0 mg/dL or >180.0 mg/dL|52 weeks|The safety set included all patients who received at least one dose of study drug.||Participants|||Number
836110|NCT01285492|Secondary|Number of Patients With Newly Occurring or Worsening Clinically Notable Hematology Values at Any Timepoint Over the Whole Treatment Period|Clinically notable hematology values were: hemoglobin - male <11.5g/dL, female <9.5 g/dL; hematocrit - male <37%, female <32%; white cell count - <2800µL or >16000µL; platelets - <7.5 10*4/µL or >70.0 10*4/µL|52 weeks|The safety set included all patients who received at least one dose of study drug.||Participants|||Number
836111|NCT01285492|Primary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) or Death|An AE was the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event was not considered to be related to study drug. Study drug includes the investigational drug under evaluation and the comparator drug or placebo that was given during any phase of the study. Adverse events starting on or after the time of the first inhalation of study drug were classified as a treatment emergent adverse event.|52 weeks|The safety set included all patients who received at least one dose of study drug.||Participants|||Number
836112|NCT01285518|Secondary|Volume of Distribution at Steady State (Vss) of PF-05231023|Vss was calculated by dividing the area under the first moment curve from time zero to infinity [AUMC(0-∞)] with the product of area under the curve from time zero to extrapolated infinite time [AUC (0 - ∞)] and apparent clearance (CL). PF-05231023 with C-terminal and N-terminal Vss were reported.|Hour(H)-1(prior to start of infusion[In] or 1 H pre-dose to bolus[Bo]),H-0.5(0.5 H post start of In or 0.5 H pre-dose to Bo),H 0(end of In or prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post end of In or post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22|PK parameter analysis set included all participants randomized and treated who have at least 1 of the PK parameters of primary interest. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure. 'n' signifies participants who were evaluable for each specified parameter for each arm, respectively.||L||Standard Deviation|Geometric Mean
836113|NCT01285518|Secondary|Back-extrapolated Concentration at Time Zero (C0) of PF-05231023|C0 was estimated by back-extrapolating from the first 2 concentration values using the log-linear regression on the first 2 data points (where second concentration was less than [<] first concentration) to back-extrapolate C0. PF-05231023 with C-terminal and N-terminal C0 were reported.|0.25 H post-dose to Bo on Day 1|PK parameter analysis set included all participants randomized and treated who have at least 1 of the PK parameters of primary interest. C0 was calculated for cohort 1 (group: PF-05231023 0.5 mg) and 2 (group: PF-05231023 1.5 mg) only as per planned analysis, hence results for the same reported.||ng/mL||Standard Deviation|Geometric Mean
836114|NCT01285518|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of PF-05231023|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). PF-05231023 with C-terminal and N-terminal AUC (0 - ∞) were reported.|Hour(H)-1(prior to start of infusion[In] or 1 H pre-dose to bolus[Bo]),H-0.5(0.5 H post start of In or 0.5 H pre-dose to Bo),H 0(end of In or prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post end of In or post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22|PK parameter analysis set included all participants randomized and treated who have at least 1 of the PK parameters of primary interest. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure. 'n' signifies participants who were evaluable for each specified parameter for each arm, respectively.||ng*hr/ml||Standard Deviation|Geometric Mean
836115|NCT01285518|Secondary|Apparent Volume of Distribution (Vz) of PF-05231023|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. PF-05231023 with C-terminal and N-terminal Vz were reported.|Hour(H)-1(prior to start of infusion[In] or 1 H pre-dose to bolus[Bo]),H-0.5(0.5 H post start of In or 0.5 H pre-dose to Bo),H 0(end of In or prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post end of In or post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22|PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure. 'n' signifies participants who were evaluable for each specified parameter for each arm, respectively.||Liter||Standard Deviation|Geometric Mean
836116|NCT01285518|Secondary|Apparent Clearance (CL) of PF-05231023 for Intravenous Bolus Dosing|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.Participants who received PF-05231023 with C-terminal and N-terminal CL were reported.|Hour (H)-1 (1 H pre-dose to bolus [Bo]),H-0.5(0.5 H pre-dose to Bo),H 0 (prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22|PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure. 'n' signifies participants who were evaluable for each specified parameter for each arm, respectively.||liter per hour||Standard Deviation|Geometric Mean
836195|NCT01286129|Primary|Change in Sputum Eosinophils Following Allergen Challenge|Eosinophil is an inflammatory cell found in the lungs. Sputum is obtained from hypertonic inhalation. patients expectorate in a sterile dish and mucus plugs are selected and treated to obtain cells. cells are transferred on a slide and a differential count is obtained where eosinophils are counted.|At 7 hours post first and last challenge compared to baseline|||percentage of sputum eosinophils||Standard Error|Mean
836117|NCT01285518|Secondary|Plasma Terminal Half-Life (t1/2) of PF-05231023|Plasma terminal half-life is the time measured for the plasma concentration to decrease by one half at the terminal phase. Participants who received PF-05231023 with C-terminal and N-terminal t1/2 were reported.|Hour(H)-1(prior to start of infusion[In] or 1 H pre-dose to bolus[Bo]),H-0.5(0.5 H post start of In or 0.5 H pre-dose to Bo),H 0(end of In or prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post end of In or post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22|PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.'n' signifies participants who were evaluable for each specified parameter for each arm, respectively.||hour||Standard Deviation|Mean
836118|NCT01285518|Secondary|Maximum Observed Plasma Concentration (Cmax) of PF-05231023|Participants who received PF-05231023 with C-terminal and N-terminal Cmax were reported.|Hour(H)-1(prior to start of infusion[In] or 1 H pre-dose to bolus[Bo]),H-0.5(0.5 H post start of In or 0.5 H pre-dose to Bo),H 0(end of In or prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post end of In or post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22|PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of primary interest.||ng/mL||Standard Deviation|Geometric Mean
836119|NCT01285518|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05231023|Participants who received PF-05231023 with C-terminal and N-terminal Tmax were reported.|Hour(H)-1(prior to start of infusion[In] or 1 H pre-dose to bolus[Bo]),H-0.5(0.5 H post start of In or 0.5 H pre-dose to Bo),H 0(end of In or prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post end of In or post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22|PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of primary interest.||hour||Full Range|Median
836120|NCT01285518|Secondary|Area Under the Curve From Time Zero to Time of Last Quantifiable Plasma Concentration (AUClast) of PF-05231023|"Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).
Participants who received PF-05231023 with C-terminal and N-terminal AUClast were reported."|Hour(H)-1(prior to start of infusion[In] or 1 H pre-dose to bolus[Bo]),H-0.5(0.5 H post start of In or 0.5 H pre-dose to Bo),H 0(end of In or prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post end of In or post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22|Pharmacokinetic (PK) parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of primary interest.||ng*hour[H]/mL||Standard Deviation|Geometric Mean
836121|NCT01285518|Primary|Number of Participants With Abnormal Cardiac Rhythms Recorded by Telemetry|Criteria for abnormal cardiac rhythms was based on investigator’s discretion and were reported as adverse event (AE), as planned.|From 2 hours (H) pre-dose for intravenous bolus or 2 H prior to the start of infusion on Day 1 up to 8 H post-dose for bolus or 8 H following the end of the infusion on Day 1|Data was not collected since this outcome measure was not analyzed as per Sponsor’s discretion.|||||
836122|NCT01285518|Primary|Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels: Day 15|Plasma samples were assayed using a validated, sensitive, and specific ICMA fluorescence method.|Day 15|Pharmacodynamic analysis set included all participants treated with PF-05231023 or placebo who had at least 1 pharmacodynamic endpoint. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.||mcg/mL||Standard Deviation|Mean
836123|NCT01285518|Primary|Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels: Day 7|Plasma samples were assayed using a validated, sensitive, and specific ICMA fluorescence method.|Day 7|Pharmacodynamic analysis set included all participants treated with PF-05231023 or placebo who had at least 1 pharmacodynamic endpoint.||mcg/mL||Standard Deviation|Mean
836124|NCT01285518|Primary|Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels: Day 5|Plasma samples were assayed using a validated, sensitive, and specific ICMA fluorescence method.|Day 5|Pharmacodynamic analysis set included all participants treated with PF-05231023 or placebo who had at least 1 pharmacodynamic endpoint.||mcg/mL||Standard Deviation|Mean
836125|NCT01285518|Primary|Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels: Day 3|Plasma samples were assayed using a validated, sensitive, and specific ICMA fluorescence method.|Day 3|Pharmacodynamic analysis set included all participants treated with PF-05231023 or placebo who had at least 1 pharmacodynamic endpoint.||mcg/mL||Standard Deviation|Mean
836126|NCT01285518|Primary|Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels: Day 2|Plasma samples were assayed using a validated, sensitive, and specific ICMA fluorescence method.|Day 2|Pharmacodynamic analysis set included all participants treated with PF-05231023 or placebo who had at least 1 pharmacodynamic endpoint.||mcg/mL||Standard Deviation|Mean
836127|NCT01285518|Primary|Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels: Day 1|Plasma samples were assayed using a validated, sensitive, and specific ICMA fluorescence method.|Day 1|Pharmacodynamic analysis set included all participants treated with PF-05231023 or placebo who had at least 1 pharmacodynamic endpoint. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.||microgram per milliliter (mcg/mL)||Standard Deviation|Mean
836128|NCT01285518|Primary|Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 15|Plasma samples for IGF-1, and GH were analyzed using a validated, sensitive, and specific immunochromatographic membrane assay (ICMA) fluorescence method. Plasma samples for IGFBP-1, IGFBP-2 were assayed using a validated, sensitive, and specific colorimetric sandwich ELISA method.|Day 15|Pharmacodynamic analysis set included all participants treated with PF-05231023 or placebo who had at least 1 pharmacodynamic endpoint. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure. 'n' signifies participants who were evaluable for each specified parameter for each arm, respectively.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
836129|NCT01285518|Primary|Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 7|Plasma samples for IGF-1, and GH were analyzed using a validated, sensitive, and specific immunochromatographic membrane assay (ICMA) fluorescence method. Plasma samples for IGFBP-1, IGFBP-2 were assayed using a validated, sensitive, and specific colorimetric sandwich ELISA method.|Day 7|Pharmacodynamic analysis set included all participants treated with PF-05231023 or placebo who had at least 1 pharmacodynamic endpoint. Here,'n' signifies participants who were evaluable at each specified time point for each arm, respectively.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
836130|NCT01285518|Primary|Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 5|Plasma samples for IGF-1, and GH were analyzed using a validated, sensitive, and specific immunochromatographic membrane assay (ICMA) fluorescence method. Plasma samples for IGFBP-1, IGFBP-2 were assayed using a validated, sensitive, and specific colorimetric sandwich ELISA method.|Day 5|Pharmacodynamic analysis set included all participants treated with PF-05231023 or placebo who had at least 1 pharmacodynamic endpoint.||nanogram per millileter (ng/mL)||Standard Deviation|Mean
836131|NCT01285518|Primary|Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 3|Plasma samples for IGF-1, and GH were analyzed using a validated, sensitive, and specific immunochromatographic membrane assay (ICMA) fluorescence method. Plasma samples for IGFBP-1, IGFBP-2 were assayed using a validated, sensitive, and specific colorimetric sandwich ELISA method.|Day 3|Pharmacodynamic analysis set included all participants treated with PF-05231023 or placebo who had at least 1 pharmacodynamic endpoint.||nanogram per millileter (ng/mL)||Standard Deviation|Mean
836132|NCT01285518|Primary|Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 2|Plasma samples for IGF-1, and GH were analyzed using a validated, sensitive, and specific immunochromatographic membrane assay (ICMA) fluorescence method. Plasma samples for IGFBP-1, IGFBP-2 were assayed using a validated, sensitive, and specific colorimetric sandwich ELISA method.|Day 2|Pharmacodynamic analysis set included all participants treated with PF-05231023 or placebo who had at least 1 pharmacodynamic endpoint.||ng/mL||Standard Deviation|Mean
836133|NCT01285518|Primary|Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 1|Plasma samples for IGF-1, and GH were analyzed using a validated, sensitive, and specific immunochromatographic membrane assay (ICMA) fluorescence method. Plasma samples for IGFBP-1, IGFBP-2 were assayed using a validated, sensitive, and specific colorimetric sandwich (enzyme-linked immunosorbent assay) ELISA method.|Day 1|Pharmacodynamic analysis set included all participants treated with PF-05231023 or placebo who had at least 1 pharmacodynamic endpoint. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
836134|NCT01285518|Primary|Number of Participants With Anti-Drug Antibodies (ADA): Day 34|Assays for the determination of human anti-drug (Anti-PF-05231023) antibodies (ADA) was performed.|Day 34|Safety population. No participant was involved in groups: PF-05231023 0.5,1.5,5,15,50,100 mg and placebo for this time point of outcome measure, hence results were not reported for the same.'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.||participants|||Number
836135|NCT01285518|Primary|Number of Participants With Anti-Drug Antibodies (ADA): Day 22|Assays for the determination of human anti-drug (Anti-PF-05231023) antibodies (ADA) was performed.|Day 22|Safety population included all participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.||participants|||Number
836136|NCT01285518|Primary|Number of Participants With Anti-Drug Antibodies (ADA): Day 15|Assays for the determination of human anti-drug (Anti-PF-05231023) antibodies (ADA) was performed.|Day 15|Safety population included all participants who received at least 1 dose of study medication. No participant in the placebo group was assessed for this time point of outcome measure, hence results were not reported for the same. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.||participants|||Number
836137|NCT01285518|Primary|Number of Participants With Anti-Drug Antibodies (ADA): Day 8|Assays for the determination of human anti-drug (Anti-PF-05231023) antibodies (ADA) was performed.|Day 8|Safety population included all participants who received at least 1 dose of study medication. No participant in the placebo group was assessed for this time point of outcome measure, hence results were not reported for the same.||participants|||Number
836138|NCT01285518|Primary|Number of Participants With Anti-Drug Antibodies (ADA): Day 1|Assays for the determination of human anti-drug (Anti-PF-05231023) antibodies (ADA) was performed.|Day 1|Safety population included all participants who received at least 1 dose of study medication. No participant in the placebo group was assessed for this time point of outcome measure, hence results were not reported for the same.||participants|||Number
836139|NCT01285518|Primary|Number of Participants With Blood Glucose Abnormalities|Criteria for blood glucose abnormality: Blood glucose levels <0.6*lower limit of normal (LLN) or >1.5*upper limit of normal (ULN).|Day -1 up to Day 15|Safety population included all participants who received at least 1 dose of study medication.||participants|||Number
836140|NCT01285518|Primary|Number of Participants With Hypoglycemic Adverse Event Based on Capillary Glucose Levels|Capillary blood glucose levels were collected to observe any hypoglycemic adverse events. Hypoglycemia was assessed as following categories; Severe hypoglycemia (1. Participant was unable to treat himself/herself, requiring assistance of another person to actively administer carbohydrate, glucagon 2. Exhibited one of following neurological symptoms memory loss, uncontrollable behavior, irrational behavior, unusual difficulty in awakening, suspected seizure, seizure or loss of consciousness, 3. Glucose <50 mg/dL confirmed on repeat measure); Documented symptomatic hypoglycemia (1. Symptoms of hypoglycaemia accompanied by a measured glucose concentration <=70 mg/dL); asymptomatic hypoglycemia (not accompanied by typical symptoms of hypoglycaemia but with a measured glucose concentration <=70 mg/dL), and probable hypoglycemia (typical symptoms of hypoglycaemia are not accompanied by a glucose determination, but was presumably caused by a plasma glucose concentration <=70 mg/dL).|Day 0 up to Day 22|Safety population included all participants who received at least 1 dose of study medication.||participants|||Number
836141|NCT01285518|Primary|Number of Participants With Electrocardiogram (ECG) Abnormalities|Criteria for potential clinical concern in ECG parameters: maximum PR interval of greater than or equal to (>=) 300 milliseconds (msec), maximum QRS interval >=140 msec, maximum QTCF interval (Fridericia’s Correction) of 450 to <480 msec, 480 to <500 msec and >=500 msec, maximum increase of >=25 percent (%) for baseline value of >200 msec for PR interval and maximum increase of >=50% for baseline value of less than or equal to (<=) 200 msec for QRS interval, maximum increase from baseline of >=30 msec to <60 msec and maximum increase from baseline of >60 msec in QTCF interval (Fridericia’s Correction).|Screening up to Day 15|Safety population included all participants who received at least 1 dose of study medication.||participants|||Number
836143|NCT01285518|Primary|Number of Participants With Abnormal Laboratory Values|Criteria for laboratory tests abnormalities included: hemoglobin, hematocrit and red blood cells (RBCs)(less than [<] 0.8*lower limit of normal[LLN]); leucocytes (<0.6/greater than [>]1.5*upper limit of normal [ULN]); platelets (<0.5*LLN/>1.75*ULN); neutrophils, lymphocytes (<0.8*LLN/>1.2*ULN); eosinophils, basophils, monocytes (>1.2*ULN); total bilirubin, direct bilirubin, indirect bilirubin (>1.5*ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (>3*ULN), total protein, albumin (<0.8*LLN/>1.2*ULN); creatinine, urea (>1.3*ULN); glucose (<0.6*LLN/>1.5*ULN); uric acid (>1.2*ULN); sodium, potassium, chloride, calcium, bicarbonate (<0.9*LLN/>1.1*ULN); urine RBCs, urine white blood cells (WBCs) (> or equal[=]20 high-powered field), urine bacteria >20 high-powered field. Total number of participants with any laboratory abnormalities was reported.|Day -1 up to Day 15|Safety population included all participants who received at least 1 dose of study medication.||participants|||Number
836144|NCT01285518|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 22 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Day 1 up to Day 22|Safety population included all participants who received at least 1 dose of study medication.||participants|||Number
836145|NCT01285518|Primary|Number of Participants With Abnormal Physical Examination Findings|Physical examination included assessment of height, weight, blood pressure and pulse rate. Criteria for abnormal physical findings was based on investigator’s discretion and were reported as adverse event (AE), as planned.|Day -1 up to Day 22|Data was not collected since this outcome measure was not analyzed as per Sponsor’s discretion.|||||
836146|NCT01285609|Secondary|Median Number of Months With Progression Free Survival (PFS) Per mWHO in Participants Who Have Received at Least One Dose of Blinded Study Therapy at Primary Endpoint|Progression-free survival (PFS) is defined as the time between the date of randomization and the date of tumor progression per Modified World Health Organization (mWHO) criteria or death, whichever occurs first. A participant who died without reported progression per mWHO criteria were considered to have progressed on the date of death. For participants who remain alive and have not progressed, PFS was censored on the date of last evaluable tumor assessment. For participants who remain alive and have no recorded post-baseline tumor assessment, PFS was censored on the day of randomization.|Randomization until 518 deaths, up to June 2015 (approximately 48 months post study start)|All treated participants who received at least one dose of blinded therapy||months||95% Confidence Interval|Median
836147|NCT01285609|Secondary|Overall Survival (OS) in All Randomized Participants at Primary Endpoint|Overall Survival (OS) was defined as the time from randomization to the date of death. Participants that had not died were censored at last known date alive. Median OS time was calculated using Kaplan-Meier Estimates. Interim analysis for the Primary Endpoint occurred when the following 2 conditions were both met: (1) 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and (2) 705 deaths were observed in all randomized participants.|Randomization until 705 deaths, up to June 2015 (approximately 48 months post study start)|All randomized participants||months||95% Confidence Interval|Median
836148|NCT01285609|Primary|Overall Survival (OS) in Participants Who Received at Least One Dose of Blinded Study Therapy at Primary Endpoint|Overall Survival (OS) was defined as the time from randomization to the date of death. Participants that had not died were censored at last known date alive. Median OS time was calculated using Kaplan-Meier Estimates. Interim analysis for the Primary Endpoint occurred when the following 2 conditions were both met: (1) 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and (2) 705 deaths were observed in all randomized participants.|Randomization until 518 deaths, up to June 2015 (approximately 48 months post study start)|All treated participants who received at least one dose of blinded therapy||months||95% Confidence Interval|Median
836149|NCT01285635|Secondary|Median Progression Free Survival in Months|Progression is defined, by RECIST (Response Evaluation Criteria in Solid Tumors), as at least a 20% increase in the sum of the longest diameter of target lesions.|3 Years|||months||95% Confidence Interval|Median
836150|NCT01285635|Secondary|Median Overall Survival in Months||3 Years|||months||95% Confidence Interval|Median
836151|NCT01285635|Secondary|Incidence of Grade 3 and 4 Toxicities by Arm|Measure the grade III/IV toxicities experienced by patients with advanced, locally recurrent, or metastatic SCCHN|3 years|||participants|||Number
836152|NCT01285635|Secondary|Median Duration of Response For All Groups Combined||3 years|All patients on study||months||Full Range|Median
836153|NCT01285635|Primary|Number of Patients With a Complete Response (CR) and Partial Response (PR)|The primary objective is to estimate the proportion of patients with a complete response (CR) and partial response(PR) defined by RECIST (Response Evaluation Criteria in Solid Tumors). CR is defined as the disappearance of all target lesions and PR is defined as at least a 20% decrease in the sum of the longest diameter of target lesions.|12 months|||Patients|||Number
836154|NCT01285713|Secondary|Dextrose Containing Intravenous Fluids (IVF) Affect Clinically Relevant Outcomes|Hypothesis 2: Admission rates, revisits to the emergency department (ED) or primary care physician, and length of illness will be decreased with the addition of dextrose to IVF. Physician and parental satisfaction will be increased with the addition of dextrose to IVF.|4 hours||||||
836155|NCT01285713|Primary|Measurement of Serum Ketones Before and After Administration of Intravenous Fluids for Acute Gastroenteritis|Measurement of serum ketones by bedside ketone meter before and after administration of IVF for both groups to determine a change in serum ketones. The hypothesis is that dextrose containing IVF will lead to a decrease in serum ketones in children with acute gastroenteritis who require IV rehydration.|4 hours|||mmol/L||Standard Deviation|Mean
836156|NCT01285791|Secondary|Change in Glucose and Triglyceride Blood Level|finding correlation between sonographic outcome using ultrasound, as measured by the decrease in the level of visceral fat-by centimeters, weight loss and blood levels of triglycerides and glucose.|18 months||||||
836157|NCT01285791|Primary|Decrease in the Visceral Fat Layer Measured by Ultrasound a Day Before and a Year After Surgery.|morbid obese patients undergoing a type of bariatric surgery either a laparoscopic gastric banding, a laparoscopic sleeve astrectomy or a laparoscopic gastric bypass, in our department will be evaluated by ultrasound 1 day before surgery and one year after surgery to determine the amount of visceral fat layer-by centimeters- that was decreased .|18 months|||visceral fat reduction in centimeters||Standard Error|Mean
836158|NCT01285843|Secondary|Radiological Evaluation to Assess the Fixation and Stability of Femoral and Acetabular Components.|Stability and fixation of both, femoral and acetabular component will be assessed counted number of events of stem subsidence, femoral and cup loosening, cup migration and presence of radiolucencies occurred during the study at 6 months and 1 year time points.|6 months, 1 year|||participants|||Number
836159|NCT01285843|Secondary|Changes From Baseline in Patient's Activity Level. Assessment Using the High Activity Arthroplasty Score.|The HAAS was designed to detect subtle variations in functional ability after lower limb arthroplasty, in a scale from 0 (minimum, the worst condition) to 18 points (maximum, the best condition) The HAAS values at each time points, 6 months and 1 year, and for each patient, will be reported as difference respect the preoperative value collected at preoperative.|6 months, 1 year|20 patients/group were enrolled at beginning but from 6 weeks to 1 year time point the score was counted for patients available. At 6 weeks the HAAS was calculated for n=20 (AMIStem) and n=19 (Quadra), at 6 months n=20 (AMIStem) and n=18 (Quadra) and at 1 year n=18 (AMistem) and n=18 (Quadra).||units on a scale (0-18)||Standard Deviation|Mean
836160|NCT01285843|Secondary|Changes From Baseline in Patients' Function. Clinical Evaluation Using the Harris Hip Score|"The items in the Harris hip score (HHS) include an analysis of the operated hip according to pain, function, mobility and stability, and an analysis of deformities, in a scale form 0 point (the worst condition) to 100 points (the best condition). The Harris Hip Score will be used to assess the subjective and objective improvement in the patient. The usefulness of the score has been designed to estimate clinical outcomes after THA and demonstrated high reliability and validity.
The HHS values at each time points, 6 weeks, 6 months and 1 year, and for each patient, will be reported as difference respect the preoperative value collected at preoperative."|6 weeks, 6 months, 1 year|20 patients/group were enrolled at beginning but from 6 weeks to 1 year time point the score was counted for patients available. At 6 weeks the HHS was calculated for n=20 (AMIStem) and n=19 (Quadra), at 6 months n=20 (AMIStem) and n=18 (Quadra) and at 1 year n=18 (AMistem) and n=18 (Quadra).||units on a scale (0-100)||Standard Deviation|Mean
836161|NCT01285843|Primary|Compare Periprosthetic Bone Mineral Density (BMD), at 1y Postoperative, in Patients That Have Undergone a Total Hip Arthroplasty (THA) Via the Direct Anterior Approach Receiving Either a Quadra or AMIStem Femoral Component.||0-12 months|||g/cm2||Standard Deviation|Mean
836162|NCT01285908|Secondary|Arterial Plasma Levels of Dihydroxyphenylglycol (DHPG)|Plasma levels of dihydroxyphenylglycol are obtained from blood samples via IV catheter.|2 experimental days|One subject was unable to tolerate tilting to 60 degrees following saline infusion and one subject was unable to tolerate tilting to 40 degrees following saline infusion; therefore the data for these subjects was not included in the saline condition.||nmol/L||Standard Deviation|Mean
836163|NCT01285908|Secondary|Arterial Plasma Levels of Norepinephrine|Plasma levels of norepinephrine are obtained from blood samples via IV catheter.|2 experimental days|One subject was unable to tolerate tilting to 60 degrees following saline infusion and one subject was unable to tolerate tilting to 40 degrees following saline infusion; therefore the data for these subjects was not included in the saline condition.||nmol/L||Standard Deviation|Mean
836164|NCT01285908|Secondary|Total Peripheral Resistance|The extent to which norepinephrine infusion affected total peripheral resistance, by comparison of total peripheral resistance at varying tilt angles during baseline and saline infusion.|2 experimental days|One subject was unable to tolerate tilting to 60 degrees following saline infusion and one subject was unable to tolerate tilting to 40 degrees following saline infusion; therefore the data for these subjects was not included in the saline condition.||mmHg/(min/L)||Standard Deviation|Mean
836165|NCT01285908|Secondary|Cardiac Output|The extent to which norepinephrine infusion affects cardiac output, by comparison of cardiac output at varying tilt angles during baseline and saline infusion.|2 experimental days|One subject was unable to tolerate tilting to 60 degrees following saline infusion and one subject was unable to tolerate tilting to 40 degrees following saline infusion; therefore the data for these subjects was not included in the saline condition.||L/min||Standard Deviation|Mean
836166|NCT01285908|Primary|Blood Pressure (Mean)|The extent to which norepinephrine infusion maintains average blood pressure, by comparison with the fractional changes in blood pressure at varying tilt angles during baseline and saline infusion.|2 experimental days|One subject was unable to tolerate tilting to 60 degrees following saline infusion and one subject was unable to tolerate tilting to 40 degrees following saline infusion; therefore the data for these subjects was not included in the saline condition.||mm Hg||Standard Deviation|Mean
836167|NCT01285908|Secondary|Cardiac Stroke Volume|The extent to which norepinephrine infusion affects cardiac stroke volume, by comparison of cardiac stroke volume at varying tilt angles during baseline and saline infusion.|2 experimental days|One subject was unable to tolerate tilting to 60 degrees following saline infusion and one subject was unable to tolerate tilting to 40 degrees following saline infusion; therefore the data for these subjects was not included in the saline condition.||mL||Standard Deviation|Mean
836168|NCT01285908|Secondary|Heart Rate|The extent to which norepinephrine infusion affects heart rate, by comparison of beat-to-beat heart rate at varying tilt angles during baseline and saline infusion.|2 experimental days|One subject was unable to tolerate tilting to 60 degrees following saline infusion and one subject was unable to tolerate tilting to 40 degrees following saline infusion; therefore the data for these subjects was not included in the saline condition.||bpm||Standard Deviation|Mean
836169|NCT01285908|Primary|Blood Pressure (Diastolic)|The extent to which norepinephrine infusion maintains blood pressure, by comparison with the changes in diastolic pressure at varying tilt angles during baseline and saline infusion.|2 experimental days|One subject was unable to tolerate tilting to 60 degrees following saline infusion and one subject was unable to tolerate tilting to 40 degrees following saline infusion; therefore the data for these subjects was not included in the saline condition.||mm Hg||Standard Deviation|Mean
836170|NCT01285908|Primary|Blood Pressure (Systolic)|The extent to which norepinephrine infusion maintains blood pressure, by comparison with the changes in systolic pressure at varying tilt angles during baseline and saline infusion.|2 experimental days|One subject was unable to tolerate tilting to 60 degrees following saline infusion and one subject was unable to tolerate tilting to 40 degrees following saline infusion; therefore the data for these subjects was not included in the saline condition.||mm Hg||Standard Deviation|Mean
836171|NCT01285947|Primary|Pain Rated by Subjects|"The mean pain scores will be compared between naïve subjects and non-naïve subjects averaged over the anatomical sites: periocular (temple), midface/cheek, and abdomen and over all the different treatments.
Pain scores were recorded along a Visual Analog Scale (VAS) with 0 (no pain- better) to 10 (maximal pain-worst). This is a 10 cm long line in which the subject was asked to draw a line on the scale with 0 (no pain- better) at one end to 10 (maximal pain-worst) at the other end. The drawn line was measured on the 10 cm line using a ruler to obtain the score."|3 hours for all treatments in one visit|||Units on a scale||Standard Deviation|Mean
836179|NCT01286077|Secondary|Tumor Response: Percentage of Participants With Partial Response (PR) Based on International Myeloma Working Group (IMWG) Response Criteria|Tumor response was assessed as PR based on IMWG response criteria as >=50% reduction of serum and reduction in 24-h urinary M protein by >=90% or to <200 mg/24 h; or serum/urine M protein unmeasurable:>=50% decrease in the difference between involved and uninvolved FLC levels; or serum/urine M protein and FLC assay unmeasurable: >=50% reduction in plasma cells provided baseline bone marrow plasma cell percentage was >=30%; or plus if present at baseline: >=50% reduction in size of soft tissue plasmocytomas.|Baseline up to end of study (approximately 4 years 7 months)|"FAS included all the randomized subjects who were eligible for efficacy analysis, that is, excluding subjects who did not have baseline and/or post-baseline data. N (number of subjects analyzed) signifies the subjects evaluable this measure."||Percentage of participants|||Number
836180|NCT01286077|Secondary|Tumor Response: Percentage of Participants With Stable Disease (SD) or Progressive Disease (PD) Based on International Myeloma Working Group (IMWG) Response Criteria|Tumor response was assessed as SD based on IMWG response criteria as not meeting criteria for CR, VGPR, PR, or progressive disease; PD as Increase of >=25% from lowest response level in any one or more of the following: serum M protein (absolute increase >=0.5 g/dl)c or urine M protein (absolute increase >=200 mg/24 h); or serum/urine M protein unmeasurable: difference between involved and uninvolved free light chain (FLC) levels; absolute increase >10 mg/dL; or % bone marrow plasma cells: absolute value >=10% or definite development of new bone lesions or soft tissue plasmocytomas or definite increase in the size of existing bone lesions or soft tissue plasmocytomas; or development of hypercalcemia attributed solely to the plasma cell proliferative disorder.|Baseline up to end of study (approximately 4 years 7 months)|"FAS included all the randomized subjects who were eligible for efficacy analysis, that is, excluding subjects who did not have baseline and/or post-baseline data. N (number of subjects analyzed) signifies the subjects evaluable this measure."||Percentage of participants|||Number
836181|NCT01286077|Secondary|Tumor Response: Percentage of Participants With Very Good Partial Response (VGPR) or Stringent Complete Response (sCR) or Complete Response (CR) Based on International Myeloma Working Group (IMWG) Response Criteria|Tumor response was assessed as VGPR based on IMWG response criteria if, a) serum/urine M protein detectable by immunofixation but not on electrophoresis or; b) greater than or equal to 90% reduction in serum M protein plus urine M protein level less than 100 milligram/24 hour. CR=normal free light chain (FLC) ratio and absence of phenotypically aberrant plasma cells (PC) in bone marrow with a minimum of 3000 total PC analyzed by multiparametric flow cytometry; Complete response (CR) negative immunofixation on the serum and urine and, disappearance of any soft tissue plasmocytomas and <5% plasma cells in bone marrow.|Baseline up to end of study (approximately 4 years 7 months)|"FAS included all the randomized subjects who were eligible for efficacy analysis, that is, excluding subjects who did not have baseline and/or post-baseline data. N (number of subjects analyzed) signifies the subjects evaluable this measure."||Percentage of participants|||Number
836196|NCT01286168|Secondary|Per Drain Analysis: Drain Bulb Fluid Colonization at Removal||Approximately one month after surgery|Analysis was modified intent-to-treat (IIT). Reported here only in those subjects where drain removal was later than primary endpoint collection.||drains|Participants||Number
836182|NCT01286077|Secondary|Change From Baseline in Quality of Life Assessed by Euro Quality of Life (EQ-5D)|Subjects were asked to rate their general state of health on a Visual analog scale (in millimeter [mm]) ranging from 0 (worst state of health) to 100 (best conceivable state of health) mm.|Baseline up to end of study (approximately 4 years 7 months)|FAS included all the randomized subjects who were eligible for efficacy analysis, that is, excluding subjects who did not have baseline and/or post-baseline data. Missing data was imputed by last observation carried forward (LOCF) method.||millimeter (mm)||Standard Deviation|Mean
836183|NCT01286077|Secondary|Overall Survival|Overall survival defined as time from first treatment of MMY, i.e. day of first dose of induction therapy for MMY to date of death|Baseline up to end of study (approximately 4 years 7 months)|"FAS included all the randomized subjects who were eligible for efficacy analysis, that is, excluding subjects who did not have baseline and/or post-baseline data. N (number of subjects analyzed) signifies the subjects evaluable this measure."||Months||Standard Error|Median
836184|NCT01286077|Secondary|Karnofsky Performance Status|"The Karnofsky performance status is a way to quantify cancer patients' general well-being and activities of daily life and runs from 100 to 0, where 100 is perfect health and 0 is death."|Baseline up to end of study (approximately 4 years 7 months)|"FAS included all the randomized subjects who were eligible for efficacy analysis, that is, excluding subjects who did not have baseline and/or post-baseline data. N (number of subjects analyzed) signifies the subjects evaluable this measure. Missing data was imputed by last observation carried forward (LOCF) method."||Units on a scale||Standard Deviation|Mean
836185|NCT01286077|Secondary|Change From Baseline in Spine T-score|T score is used to calculate bone mineral density (calcium and other types of minerals) in an area of the bone. T score is the number of standard deviations above or below the mean for a healthy 30 year old adult of the same sex and ethnicity as a participant. This score is calculated from participant's age, gender and race and skeletal site. T score has a mean of ‘50’ and a standard deviation of ‘10’. T score lower than its mean indicate low bone mineral density.|Baseline up to end of study (approximately 4 years 7 months)|"FAS included all the randomized subjects who were eligible for efficacy analysis, that is, excluding subjects who did not have baseline and/or post-baseline data. N (number of subjects analyzed) signifies the subjects evaluable this measure. Missing data was imputed by last observation carried forward (LOCF) method."||T score||Standard Deviation|Mean
836186|NCT01286077|Secondary|Appearance of New Bone Lesions Compared to Baseline|Appearance of new bone lesions assessed by skeletal survey compared to baseline|Baseline up to end of study (approximately 4 years 7 months)|Data could not be summarised statistically due to insufficient data at End of treatment.||subjects|||Number
836187|NCT01286077|Secondary|Number of Patients With Skeletal Events|Number of patients with skeletal-related events (i.e. pathological fracture (vertebral, non-vertebral, combined), radiotherapy, spinal cord compression, orthopaedic surgery, hypercalcaemia) occurring over 24 months study period|Baseline up to end of study (approximately 4 years 7 months)|"FAS included all the randomized subjects who were eligible for efficacy analysis, that is, excluding subjects who did not have baseline and/or post-baseline data. N (number of subjects analyzed) signifies the subjects evaluable this measure."||patients|||Number
836188|NCT01286077|Secondary|Change From Baseline in Biochemical Bone Markers: Dickkopf Homolog 1 (DKK-1)|Bone markers Dickkopf homolog 1 (DKK-1) was measured on serum samples.|Baseline up to end of study (approximately 4 years 7 months)|"FAS was used for analysis. N (number of subjects analyzed) signifies the subjects evaluable this measure and n=number pf participants analysed for this outcome measure at specific time point. Missing data was imputed by last observation carried forward (LOCF) method."||Picomole per liter||Standard Deviation|Mean
836189|NCT01286077|Secondary|Change From Baseline in Biochemical Bone Markers: Carboxyterminal Collagen Crosslinks (CTX-I)|Change from Baseline in Biochemical Bone Markers: CTX-I was assessed|Baseline up to end of study (approximately 4 years 7 months)|"FAS was used for analysis. N (number of subjects analyzed) signifies the subjects evaluable this measure and n=number pf participants analysed for this outcome measure at specific time point. Missing data was imputed by last observation carried forward (LOCF) method."||Nanogram per liter||Standard Deviation|Mean
836190|NCT01286077|Secondary|Change From Baseline in Biochemical Bone Markers:Carboxyterminal Telopeptide of Type I Collagen (ICTP), Osteocalcin, Bone-specific Alkaline Phosphatase (BAP)|Bone markers (carboxyterminal telopeptide of type I collagen (ICTP), osteocalcin (Oc) and bone-specific alkaline phosphatase (BAP) was measured on serum samples.|Baseline up to end of study (approximately 4 years 7 months)|"FAS was used for analysis. N (number of subjects analyzed) signifies the subjects evaluable this measure and n=number pf participants analysed for this outcome measure at specific time point. Missing data was imputed by last observation carried forward (LOCF) method."||Microgram per liter||Standard Deviation|Mean
836191|NCT01286077|Secondary|Progression Free Survival|The Progression-Free Survival (PFS) was assessed as median number of months from baseline until the first documented sign of disease progression (increase in disease; radiographic, clinical, or both) or death due to any cause, whichever occurred earlier.|Baseline up to end of study (approximately 4 years 7 months)|Full Analysis Set (FAS) included all the randomized subjects who were eligible for efficacy analysis, that is, excluding subjects who did not have baseline and/or post-baseline data.||Months||Standard Error|Mean
836192|NCT01286077|Primary|Change From Baseline in Bone Mineral Density (BMD) in the Femur at End of Treatment|Change from baseline in bone mineral density (BMD) will be assessed by dual energy x-ray absorptiometry scans at baseline and the end of treatment EOT visit|at screening (i.e. between 14 and 1 days prior to start of treatment) and at end of treatment (EOT), i.e. 24 weeks after randomization or until start of alternative MMY therapy, if earlier|ITT analysis:8 patients in the bortezomib group and 8 patients in the non-treated control group did not have values at the 2 timepoints to allow calculation of the parameter||g/mm2||Standard Deviation|Mean
836193|NCT01286077|Primary|Change From Baseline in Bone Mineral Density (BMD) in the Spine at End of Treatment (EOT)|Change from baseline in bone mineral density (BMD) will be assessed by dual energy x-ray absorptiometry scans at baseline and the EOT visit|at screening (i.e. between 14 and 1 days prior to start of treatment) and at end of treatment (EOT), i.e. 24 weeks after randomization or until start of alternative MMY therapy, if earlier|ITT analysis:13 patients in the bortezomib group and 14 patients in the non-treated control group did not have values at the 2 timepoints to allow calculation of the parameter||g/mm2||Standard Deviation|Mean
836197|NCT01286168|Secondary|Per Drain Analysis: Drain Tubing Colonization at Removal||Approximately one month after surgery|Analysis was modified intent-to-treat; subjects who withdrew or were screen failures before study intervention were excluded. All patients who completed were included in the analysis. 2 subjects missed endpoint due of protocol deviation or discontinuation, and 2 had the sterility of their drain tubing compromised by external exposures.||drains|Participants||Number
836198|NCT01286168|Primary|Per Drain Analysis: Drain Bulb Fluid Colonization at Approximately 1 Week||Approximately 1 week after surgery|Analysis was modified intent-to-treat (IIT); subjects who withdrew or were screen failures before study intervention were excluded. All patients who completed were included in the analysis.||drains|Participants||Number
836199|NCT01286168|Secondary|Number of Subjects With Surgical Site Infection Within 1 Year||Approximately one year after surgery|||participants|||Number
836200|NCT01286168|Secondary|Number of Subjects With Surgical Site Infection Within 30 Days||Approximately 30 days after surgery|Analysis was modified intent-to-treat (IIT); subjects who withdrew or were screen failures before study intervention were excluded. All patients who completed were included in the analysis.||participants|||Number
836201|NCT01286168|Secondary|Number of Subjects With Drain Bulb Fluid Bacterial Colonization at Removal|Bacterial growth was defined as plate growth of 1+ or greater. Drains were removed a variable times across patients, per clinical indication. A second bulb culture was obtained later than 1 week ONLY in those drains that were not removed at 1 week.|Approximately 2 weeks after surgery|Analysis was modified intent-to-treat (IIT). Reported here only in those subjects where drain removal was later than primary endpoint collection.||participants|||Number
836202|NCT01286168|Secondary|Number of Subjects With Drain Tubing Colonization at Removal|Drain tubing colonization was defined as greater than 50 colony forming units. Drains were removed at variable timepoints based on the clinical situation.|Approximately two weeks after surgery|Analysis was modified intent-to-treat; subjects who withdrew or were screen failures before study intervention were excluded. All patients who completed were included in the analysis. 2 subjects missed endpoint due of protocol deviation or discontinuation, and 2 had the sterility of their drain tubing compromised by external exposures.||participants|||Number
836203|NCT01286168|Primary|Number of Subjects With Drain Bulb Fluid Bacterial Colonization at Approximately 1 Week|Bacterial growth was defined as plate growth of 1+ or greater. Drains were removed at variable times across patients, per clinical indication. When clinically indicated, some patients did have their drains removed at the one week visit, in which case they only had one bulb fluid culture.|Approximately 1 week after surgery|Analysis was modified intent-to-treat (IIT); subjects who withdrew or were screen failures before study intervention were excluded. All patients who completed were included in the analysis.||participants|||Number
836204|NCT01286207|Primary|Number of Participants With Drug-related Lab Adverse Experiences|"Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) laboratory adverse experience (LAE).
A LAE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product."|Up to 12 weeks|All patients who took study medication and had lab test(s)were included in the analysis.||participants|||Number
836205|NCT01286207|Primary|Number of Participants Who Discontinued Due to Clinical Adverse Experiences||Up to 12 months|All patients who took study medication were included in the analysis.||participants|||Number
836206|NCT01286207|Primary|Number of Participants With Drug-related Clinical Adverse Experiences|Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs.|Up to 12 months|All patients who took study medication were included in the analysis.||participants|||Number
836207|NCT01286207|Primary|Number of Participants With Serious Clinical Adverse Experiences|Serious clinical adverse experiences (CAEs) are any adverse events (AEs) occurring at any dose that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.|Up to 12 months|All patients who took study medication were included in the analysis.||participants|||Number
836208|NCT01286207|Primary|Percent of Patient's Headaches With Pain Relief at 2 Hours After the Initial Dose of Test Drug|Headache severity was rated on a 4-point scale (0 = no headache; 1 = mild pain; 2 = moderate pain; 3 = severe pain) immediately before initial dose and at 2 hours thereafter. Pain relief was defined as a reduction of headache severity from grades 2/3 at baseline to 0/1.|2 hours after initial dose of test drug|All patients who took study medication and filled out their diary cards were included in the analysis of efficacy. No data were imputed.||percent of headaches||Inter-Quartile Range|Median
836209|NCT01286311|Secondary|Presence of an Aspirin Prescription|This will measure the presence of an aspirin prescriptions on the medication list in the electronic medical record.|9 months|38 patients in the intervention arm and 50 patients in the control arm had aspirin listed in their medication list in the electronic medical record as the start of the study therefore they were excluded from this analysis.||% patients w/aspirin now on med list|||Number
836210|NCT01286311|Secondary|Percentage of Patients With Uncontrolled Hypertension Who Had an Increase in the Number of Antihypertensive Medication Drug Classes Prescribed|This will measure the percentage of participants who had uncontrolled hypertension at baseline who had an increase in the number of antihypertensive medication drug classes prescribed within 9 months.|9 months|Among patients with uncontrolled hypertension, 76 of the 218 in the intervention arm and 85 of 217 in the control arm were included.||percentage of participants|||Number
836211|NCT01286311|Secondary|Medication Prescriptions for Dyslipidemia|This will look at whether lipid lowering medications (LLM) were prescribed for dyslipidemia.|9 months|||% of patients with New Rx for LLM|||Number
836212|NCT01286311|Secondary|Frequency of Clinical Encounters|This will measure the difference in frequency of clinical encounters in the electronic medical record.|9 months|||% of patients with any office visit|||Number
836213|NCT01286311|Primary|Comparative Outcomes: Intervention Group LDL Reduction Compared to Control Group LDL Reduction|Significant LDL cholesterol reduction at 9 months Definition: Percentage of patients with LDL-C repeated and which is at least 30 mg/dl lower than baseline|9 months|||% of patients with major LDL reduction|||Number
836215|NCT01286324|Secondary|To Determine the Change From Baseline of Chamomile on Daytime Functioning Measures|"Change from baseline of chamomile extract, three tablets p.o. twice times daily versus placebo on daytime functioning measures at 28 days:
the change from baseline of measures of depression and anxiety evaluated respectively with the Beck Depression Inventory-II (BDI-II) and trait portrait of the State Trait Anxiety Index (STAI);
the change from baseline of fatigue as determined by the Fatigue Severity Scale of Sleep Disorders (FSS);
the change from baseline of global QOL (as determined by the 12 Item Short Form Health Survey Version 2 {SF-12 V2})"|baseline and day 28||||||
836216|NCT01286324|Primary|Change From Baseline of Chamomile Extract on Measures of Sleep at Day 28.|"Change from baseline of chamomile extract, three tablets (equivalent to 7.5 g of dried herb) p.o. twice times daily versus placebo on the following sleep measures at 28 days:
the change from baseline of daily self-report of sleep as assessed by a sleep diary that includes determination of: (i) sleep efficiency, which equals The total sleep time divided by time-in-bed, multiplied by 100. This measure is our primary aim (SE)."|baseline and day 28|||percentage of time asleep||Standard Deviation|Least Squares Mean
836217|NCT01286402|Secondary|Perinatal/Neonatal Outcomes||at neonatal discharge from hospital following delivery||||||
836218|NCT01286402|Secondary|Maternal Side Effects||during treatment, end of treatment and at 2 week postpartum visit||||||
836219|NCT01286402|Secondary|Self-reported Reduction in Number of Cigarettes Smoked Per Day||at 1 week post treatment and at 2 week postpartum visit||||||
836220|NCT01286402|Secondary|Continuous Abstinence From Birth to 2nd Week Postpartum Followup||at 2nd week postpartum followup visit||||||
836221|NCT01286402|Secondary|Continuous Abstinence From End of Treatment Through the 2 Week Followup||at two week followup visit||||||
836222|NCT01286402|Secondary|Enrollment, Retention and Compliance Rates||1 year (estimated)||||||
836223|NCT01286402|Primary|7-day Point Prevalence Smoking Abstinence With Cotinine Validation at the End of Treatment||1 week post treatment|||participants|||Number
836224|NCT01286454|Secondary|Plasma Decay Half Life (t1/2) for Fesoterodine Metabolite (5-HMT)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Here, the N (number of participants analyzed) is signifying the number of participants contributing to the mean.||hr||Standard Deviation|Mean
836225|NCT01286454|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) for Fesoterodine Metabolite (5-HMT)||0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||hr||Full Range|Median
836226|NCT01286454|Primary|Maximum Observed Plasma Concentration (Cmax) for Fesoterodine Metabolite (5-HMT)||0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng/mL||Standard Deviation|Geometric Mean
836227|NCT01286454|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Fesoterodine Metabolite (5-HMT)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) of 5-HMT.|0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng*hr/mL||Standard Deviation|Geometric Mean
836228|NCT01286454|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] for Fesoterodine Metabolite (5-hydroxymethyltolterodine [5-HMT])|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hours (hrs) post dose|Pharmacokinetic (PK) parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Here, the N (number of participants analyzed) is signifying the number of participants contributing to the mean.||ng*hr/mL||Standard Deviation|Geometric Mean
836229|NCT01286480|Secondary|MyHeart Score|Change in patient knowledge of his/her CHD (MyHeart score), comparing baseline to 1 month and 6 months follow-up. The MyHeart scale was developed for this study and has a grade 4.6 reading level. It consists of seven short answer or multiple-choice questions. Given the heterogeneity of prior medical and surgical interventions and need for medications in adolescents with heart disease, the denominator for some questions varied from one participant to the next. Accordingly, each participant was assigned a percentage correct score (numerator/denominator×100) at each time point. Higher percentage correct score reflects better patient knowledge of his/her CHD|Baseline, 1 month and 6 months|||percentage of score||Standard Deviation|Mean
836230|NCT01286480|Primary|Transition Readiness Assessment Questionnaire (TRAQ) Score|The TRAQ is the most rigorously evaluated transition readiness questionnaire available and was developed in the USA. It has 29 items with two domains, self-management (16 items) and self-advocacy (13 ). The TRAQ is at a grade 5.7 reading level and uses a Likert scale. Each item is scored 1-5, with 1 being assigned for responses of “No, I do not know how” and a score of 5 assigned for responses of “Yes, I always do this when I need to.” The TRAQ scores produced include an overall score and a subscale score. The overall score and the subscale scores are calculated simply by taking the average score across the items in the questionnaire (or subscale). The higher the score, the greater the perceived self-management or self-advocacy skills of the participant. The lower scores indicate the participant has a lower perceived level of self-management or self-advocacy.|Baseline, 1 month and 6 months|The intervention involve a 60 minute interaction between the teen and an advanced practice nurse (APN) in the cardiology clinic. The youth in the usual care arm see a nurse for vitals. They rely on their cardiologist for information about their heart condition. The approach and amount of time taken by each cardiologist with a youth varies.||units on a scale||Standard Deviation|Mean
836231|NCT01286493|Primary|Rabies Neutralizing Antibody Titers|"Rabies Neutralizing Antibody titers(RNab)of HIV-infected patients who receive booster rabies vaccination would be measured by Rapid Fluorescent Focus Inhibition Test(RFFIT) method at day 0, 7, 14, 28, 90,180 and 360. RNab level above 0.5 IU/ml indicate acceptable protective antibody response.
for 7 times in 1 year."|Day 360|As preliminary study, the number of participants was estimated to be above 15 - 20 cases.||IU/ml||Full Range|Geometric Mean
836235|NCT01286558|Secondary|Seated SBP Control Rate at Trough|SBP control rate: The rate of patients with controlled seated DBP at trough of less than 140 mmHg after the 8-week double-blind period At trough: 24-hour post-dosing|8 weeks|Patients included in FAS and with seated SBP >=140 mmHg at reference baseline||percentage of participants|||Number
836236|NCT01286558|Secondary|Seated DBP Control Rate at Trough|DBP control rate: The rate of patients with controlled seated DBP at trough of less than 90 mmHg after the 8-week double-blind period At trough: 24-hour post-dosing|8 weeks|Patients included in FAS and with seated DBP >=90 mmHg at reference baseline||percentage of participants|||Number
836237|NCT01286558|Secondary|Changes From the Reference Baseline in SBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM|Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined|Reference baseline, 8 weeks|ABPM set, i.e., a subset of FAS and with patients who had available ABPM measurements||mm Hg||Standard Deviation|Mean
836238|NCT01286558|Secondary|Changes From the Reference Baseline in DBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM|Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined|Reference baseline, 8 weeks|ABPM set, i.e., a subset of FAS and with patients who had available ABPM measurements||mm Hg||Standard Deviation|Mean
836239|NCT01286558|Secondary|Changes From the Pseudo-baseline in the 24-hour ABPM Mean (Relative to Dose Time) for SBP|Pseudo-baseline: Status of patients after the 6-week open-label run-in period with telmisartan monotherapy, where patients' eligibility to enter the double-blind treatment period was examined|Pseudo-baseline, 14 weeks|ABPM set, i.e., a subset of FAS and with patients who had available ABPM measurements||mm Hg||Standard Error|Least Squares Mean
836240|NCT01286558|Secondary|Changes From the Pseudo-baseline in the 24-hour ABPM Mean (Relative to Dose Time) for DBP|Pseudo-baseline: Status of patients after the 6-week open-label run-in period with telmisartan monotherapy, where patients' eligibility to enter the double-blind treatment period was examined|Pseudo-baseline, 14 weeks|ABPM set, i.e., a subset of FAS and with patients who had available ABPM measurements||mm Hg||Standard Error|Least Squares Mean
836241|NCT01286558|Secondary|Changes From the Reference Baseline in the 24-hour ABPM Mean (Relative to Dose Time) for SBP|Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined|Reference baseline, 8 weeks|ABPM set, i.e., a subset of FAS and with patients who had available ABPM measurements||mm Hg||Standard Error|Least Squares Mean
836242|NCT01286558|Secondary|Changes From the Reference Baseline in the 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Mean (Relative to Dose Time) for DBP|Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined|Reference baseline, 8 weeks|ABPM set, i.e., a subset of FAS and with patients who had available ABPM measurements||mm Hg||Standard Error|Least Squares Mean
836243|NCT01286558|Secondary|Reduction From the Reference Baseline in Mean Seated Systolic Blood Pressure (SBP) at Trough|Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined At trough: 24-hour post-dosing|Reference baseline, 8 weeks|FAS||mm Hg||Standard Error|Least Squares Mean
836244|NCT01286558|Primary|Reduction From the Reference Baseline in Mean Seated Diastolic Blood Pressure (DBP) at Trough|Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined At trough: 24-hour post-dosing|Reference baseline, 8 weeks|Full analysis set (FAS)||mm Hg||Standard Error|Least Squares Mean
836245|NCT01286740|Secondary|Plasma Concentration of RPV at Week 48|The mean (SD) plasma concentration (ng/mL) of RPV was measured at Week 48.|Week 48|Participants with evaluable measurements for plasma concentration of RPV at Week 48 were analyzed.||ng/mL||Standard Deviation|Mean
836246|NCT01286740|Secondary|Plasma Concentration of RPV at Week 36|The mean (SD) plasma concentration (ng/mL) of RPV was measured at Week 36.|Week 36|Participants with evaluable measurements for plasma concentration of RPV at Week 36 were analyzed.||ng/mL||Standard Deviation|Mean
836247|NCT01286740|Secondary|Plasma Concentration of RPV at Week 24|The mean (SD) plasma concentration (ng/mL) of RPV was measured at Week 24.|Week 24|Participants with evaluable measurements for plasma concentration of RPV at Week 24 were analyzed.||ng/mL||Standard Deviation|Mean
836248|NCT01286740|Secondary|Plasma Concentration of EFV at Week 12|The mean (SD) plasma concentration (ng/mL) of EFV was measured at Week 12. No analyses of EFV plasma concentrations were conducted after Week 12|Week 12|Participants with evaluable measurements for plasma concentration of EFV at Week 12 were analyzed.||ng/mL||Inter-Quartile Range|Mean
836249|NCT01286740|Secondary|Plasma Concentration of RPV at Week 12|The mean (SD) plasma concentration (ng/mL) of RPV was measured at Week 12.|Week 12|Participants with measurements for plasma concentration of RPV at Week 12 were analyzed.||ng/mL||Standard Deviation|Mean
836250|NCT01286740|Secondary|Plasma Concentration of RPV and EFV at Week 8|The mean (SD) plasma concentration (ng/mL) of RPV and EFV was measured at Week 8.|Week 8|Participants with evaluable measurements for plasma concentration of RPV and EFV at Week 8 were analyzed.||ng/mL||Standard Deviation|Mean
836251|NCT01286740|Secondary|Plasma Concentration of RPV and EFV at Week 6|The mean (SD) plasma concentration (ng/mL) of RPV and EFV was measured at Week 6.|Week 6|Participants with evaluable measurements for plasma concentrations of RPV and EFV at Week 6 were analyzed.||ng/mL||Standard Deviation|Mean
836252|NCT01286740|Secondary|Plasma Concentration of RPV and EFV at Week 4|The mean (SD) plasma concentration (ng/mL) of RPV and EFV was measured at Week 4.|Week 4|Participants with evaluable measurements for plasma concentrations of RPV and EFV at Week 4 were analyzed.||ng/mL||Standard Deviation|Mean
836253|NCT01286740|Secondary|Plasma Concentration of RPV and EFV at Week 2|The mean (SD) plasma concentration (ng/mL) of RPV and EFV was measured at Week 2.|Week 2|Participants with evaluable measurements for plasma concentrations of RPV and EFV at Week 2 were analyzed.||ng/mL||Standard Deviation|Mean
836257|NCT01286740|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 (FDA Snapshot Analysis)|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 12 was analyzed using the FDA snapshot analysis.|Week 12|Full Analysis Set: participants who were enrolled into the study, received at least one dose of study drug and had no major protocol violation||percentage of participants|||Number
836258|NCT01286753|Secondary|Pharmacokinetics of Vemurafenib: Area Under the Concentration-Time Curve (AUC)|AUC is a measure of the drug or biologic concentration in the body following administration.|Up to approximately 4 years|Data were not collected for this outcome.|||||
836259|NCT01286753|Secondary|Percentage of Participants With Adverse Events|An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Baseline until 28 days after the last dose of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 4 years)|Safety population, defined as enrolled participants who received at least one dose of study treatment.||percentage of participants|||Number
836260|NCT01286753|Secondary|Overall Survival|Overall survival: the interval between the date of first treatment to the date of death, regardless of the cause of death; participants who were alive at the time of the analysis were censored at the date of the last known alive; participants with no post baseline information were censored at the time of enrollment.|From the date of first treatment to the date of death for any cause (up to approximately 4 years)|Intent-to-Treat population, defined as all enrolled participants.||months||95% Confidence Interval|Median
836261|NCT01286753|Secondary|Progression-Free Survival|Progression-free survival: the interval between the day of first treatment and the first documentation of PD or death; participants who were withdrawn from the study without documented progression were censored at the date of the last tumor assessment when the participant was known to be progression-free; participants without post baseline tumor assessments were censored at the time of enrollment. PD: ≥ 20% increase in the sum of diameters of target lesions, compared to the smallest sum on study.|From the day of first treatment until the first documented PD or death (up to approximately 4 years)|Efficacy population, defined as all enrolled participants who received at least one dose of study treatment and excluding 3 participants in the TKI Experienced group who had previous BRAFi or MEKi treatment or withdrew consent.||months||95% Confidence Interval|Median
836262|NCT01286753|Secondary|Duration of Response|Duration of response (for participants with confirmed best response CR or PR): the interval between earliest qualifying response and date of progression of disease (PD) or death for any cause, whichever occurred first; participants with no documented progression after CR or PR were censored at the date of last known CR or PR, respectively. CR: disappearance of all target lesions with reduction in target/non-target pathological lymph nodes to < 10 mm. PR: ≥ 30% decrease in the sum of diameters of target lesions, compared to the baseline sum diameters. PD: ≥ 20% increase in the sum of diameters of target lesions, compared to the smallest sum on study.|From the date of first qualifying response to the date of PD or death for any cause (up to approximately 4 years)|Efficacy population, defined as all enrolled participants who received at least one dose of study treatment and excluding 3 participants in the TKI Experienced group who had previous BRAFi or MEKi treatment or withdrew consent.||months||95% Confidence Interval|Median
836263|NCT01286753|Secondary|Clinical Benefit Rate|Clinical benefit rate: the percentage of participants with confirmed CR, PR, or stable disease (SD; maintained for at least 6 months) as assessed by investigators according to RECIST v1.1. CR: disappearance of all target lesions with reduction in target/non-target pathological lymph nodes to < 10 mm. PR: ≥ 30% decrease in the sum of diameters of target lesions, compared to the baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, compared to the baseline sum diameters.|Up to approximately 4 years|Efficacy population, defined as all enrolled participants who received at least one dose of study treatment and excluding 3 participants in the TKI Experienced group who had previous BRAFi or MEKi treatment or withdrew consent.||percentage of participants||95% Confidence Interval|Number
836264|NCT01286753|Secondary|Best Overall Response Rate in TKI-Experienced Participants|Best overall response rate was assessed by the investigators according to RECIST v1.1. Best overall response rate: the percentage of participants with best objective response of CR or PR (calculated as the number of participants with best response CR or PR divided by the total number of efficacy-evaluable participants). CR: disappearance of all target lesions with reduction in target/non-target pathological lymph nodes to < 10 mm. PR: ≥ 30% decrease in the sum of diameters of target lesions, compared to the baseline sum diameters.|Up to approximately 4 years|Efficacy population (TKI Experienced group only), defined as all enrolled participants who received at least one dose of study treatment and excluding 3 participants in the TKI Experienced group who had previous BRAFi or MEKi treatment or withdrew consent.||percentage of participants||95% Confidence Interval|Number
836265|NCT01286753|Primary|Best Overall Response Rate in TKI-Naive Participants|Best overall response rate was assessed by the investigators according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Best overall response rate: the percentage of participants with best objective response of complete response (CR) or partial response (PR) (calculated as the number of participants with best response CR or PR divided by the total number of efficacy-evaluable participants). CR: disappearance of all target lesions with reduction in target/non-target pathological lymph nodes to < 10 millimeters (mm). PR: ≥ 30% decrease in the sum of diameters of target lesions, compared to the baseline sum diameters.|Up to approximately 4 years|Efficacy population (TKI Naive group only), defined as all enrolled participants who received at least one dose of study treatment and excluding 3 participants in the TKI Experienced group who had previous BRAFi or MEKi treatment or withdrew consent.||percentage of participants||95% Confidence Interval|Number
836266|NCT01292746|Primary|Change in Non-vellus Terminal Hair Count Across a 3 cm Diameter Scalp Area|Non-vellus terminal hair count was calculated across a tattooed 3 cm diameter scalp area from digital photographs of the area by independent blinded evaluator employing macroimage analysis software.|Baseline and 13 Weeks|||hairs/cm2||Standard Deviation|Mean
836267|NCT01292798|Secondary|Qualitative Assessment of Diabetic Macular Edema (DME)|To compare the percentage of subjects with compete or partial/no resolution of diabetic macular edema in response to the ranibizumab 0.5 and 2.0 mg doses.|Baeline and 6 months|At 6 months, 18 out of the 43 subjects (42%) showed complete resolution of DME. 25 out of the 43 subjects (58%) showed partial or no resolution of DME at 6 months.||percentage of participants|||Number
836268|NCT01292798|Secondary|Mean Change in 1-mm Central Subfield (CST) Thickness as Measured by OCT at Month 6 Compared to Baseline|To determine the mean change in central 1-mm subfield thickness as measured by spectral-domain OCT from baseline to 6 months .|baseline and 6 months|||microns||Standard Deviation|Mean
836269|NCT01292798|Primary|Overall Mean Change in Visual Acuity Scores at Month 6 Compared to Baseline|To determine the mean change in the best-corrected visual acuity on an ETDRS visual acuity chart at a starting distance of 4 meters from baseline to 6 months.|baseline and 6 months|||letters||Standard Deviation|Mean
836270|NCT01292837|Secondary|Generalized Tonic-clonic Seizure Freedom Over the Evaluation Period|A subject with a generalized tonic-clonic seizure frequency of 0 per week throughout the Evaluation Period was considered a seizure-free subject for that period.|Evaluation Period (Week 4 to Week 24)|"The Analysis Population refers to the Full Analysis Set (FAS). The FAS was a subset of the Safety Set and included all subjects with Combined Baseline Period (Retrospective and Prospective) and post-Baseline Generalized Tonic-Clonic seizure counts as the primary efficacy analysis.
One subject discontinued the study during the Up-Titration Period."||participants|||Number
836271|NCT01292837|Secondary|Generalized Tonic-clonic Seizure Freedom Over the Treatment Period|A subject with a generalized tonic-clonic seizure frequency of 0 per week throughout the Treatment Period was considered a seizure-free subject for that period.|Treatment Period (Week 0 to Week 24)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS was a subset of the Safety Set and included all subjects with Combined Baseline Period (Retrospective and Prospective) and post-Baseline Generalized Tonic-Clonic seizure counts as the primary efficacy analysis.||participants|||Number
836272|NCT01292837|Secondary|Generalized Tonic-clonic Seizures 50 % Responder Rate During the Evaluation Period|The 50 % responder rate during the Evaluation Period was the proportion of subjects who reported a ≥50 % reduction in seizure frequency per week from Baseline during the Evaluation Period.|From Baseline (Week -8) to Evaluation Period (Week 4 to Week 24)|"The Analysis Population refers to the Full Analysis Set (FAS). The FAS was a subset of the Safety Set and included all subjects with Combined Baseline Period (Retrospective and Prospective) and post-Baseline Generalized Tonic-Clonic seizure counts as the primary efficacy analysis.
One subject discontinued the study during the Up-Titration Period."||percentage of participants|||Number
836273|NCT01292837|Secondary|Generalized Tonic-clonic Seizures 50 % Responder Rate (the Proportion of Subjects With 50 % or More Reduction From the Combined Baseline in the Frequency of Generalized Tonic-clonic Seizures) During the Treatment Period|The 50 % responder rate during the Treatment Period was the proportion of subjects who reported a ≥ 50 % reduction in seizure frequency per week from Baseline during the Treatment Period.|From Baseline (Week -8) to Treatment Period (Week 0 to Week 24)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS was a subset of the Safety Set and included all subjects with Combined Baseline Period (Retrospective and Prospective) and post-Baseline Generalized Tonic-Clonic seizure counts as the primary efficacy analysis.||percentage of participants|||Number
836274|NCT01292837|Secondary|The Percent Change in Generalized Tonic-clonic Seizure Frequency Per Week From the Combined Baseline Period Over the Evaluation Period|"The percent change from Combined Baseline over Evaluation Period was calculated from the Generalized Tonic-Clonic (GTC) seizure frequency per week during the Evaluation Period (E) and during the Baseline Period (B, Combined Baseline, ie, Retrospective and Prospective Baseline Periods) using the equation below.
The percent change from Baseline = (B - E)/B x 100
The seizure frequency per week was calculated using the following formula:
Frequency per week of GTC seizures = total number of GTC seizures in the corresponding period / number of days for observation in the corresponding period x 7"|From Baseline (Week -8) to Evaluation Period (Week 4 to Week 24)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS was a subset of the Safety Set and included all subjects with combined Baseline Period and post-Baseline generalized tonic-clonic seizure counts. 12 of the 13 subjects in the FAS were included in the analysis excluding 1 subject discontinued before the Evaluation Period.||percent change||Standard Deviation|Mean
836275|NCT01292837|Primary|The Percent Change From the Combined Baseline (4-week Retrospective Baseline and 4-week Prospective Baseline) in the Generalized Tonic-clonic Seizure Frequency Per Week Over the 24-week Treatment Period (Up-Titration and Evaluation Periods)|"The percent change from Combined Baseline over Treatment Period was calculated from the Generalized Tonic-Clonic (GTC) seizure frequency per week during the Treatment Period (T) and during the Baseline Period (B, Combined Baseline, ie, Retrospective and Prospective Baseline Periods) using the equation below.
The percent change from Baseline = (B - T)/B x 100
The seizure frequency per week was calculated using the following formula:
Frequency per week of GTC seizures = total number of GTC seizures in the corresponding period / number of days for observation in the corresponding period x 7"|From Baseline (Week -8) to Treatment Period (Week 0 to Week 24)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS was a subset of the Safety Set and included all subjects with Combined Baseline Period (Retrospective and Prospective) and post-Baseline Generalized Tonic-Clonic seizure counts as the primary efficacy analysis.||percent change||Standard Deviation|Mean
836276|NCT01292876|Secondary|Percentage of Participants With Remodeling Response Approximately 6 Months Post-operative|The secondary objective is to examine the cellular properties of the biopsy tissue material in each subject for future correlation with clinical outcomes. Seven biopsy samples were collected and stained with Hematoxylin and eosin (H&E) and Masson’s trichrome stain. Tissue was stained with antibodies against the progenitor cell markers CD146 and NG2 to show evidence of progenitor cell migration into the remodeling injury site.|Approximately 6 months post-operative|Demonstrated remodeling response; discrepancy from from those completed in the study (12 of 13) is result of 1 subject not undergoing pathological examination.||percentage of participants remodeling|||Number
836277|NCT01292876|Primary|Percent Change From Baseline in the Rectified and Integrated EMG Signal of the Tibialis Anterior Muscle At 24 Weeks Post-Operative|The physical therapy program was designed to promote activation of the dorsiflexor muscles on the operated side, through manual feedback during volitional contractions.|approximately 24 weeks post-operative|||% change||95% Confidence Interval|Mean
836309|NCT01294046|Secondary|Pain Free at 2 Hours Post Stimulation|As noted above, we are using the FDA-approved categorical scale used for all migraine regulatory trials since 1992. This is a 4 point categorical scale where 0= no pain, 1= mild headache pain, 2= moderate pain, and 3= severe pain. Pain free is defined as the subject moving from pain intensity of 2 to 3 at baseine to 0 by 2 hours after stimulation.|8.5 months|No data were collected from this entire study, so no data were analyzed.|||||
836278|NCT01292928|Other Pre-specified|Quality of Life|Improved Quality of Life assessed by the SF-36 Health Survey. The validated SF-36 Survey, where scores are calibrated so that 50 is the average score or norm, was utilized (scores ranging from 0, worst possible health to 100, best possible health). The SF-36 is a multipurpose, proprietary health survey with 36 questions that yield eight health component scales that can be further summarized into two summary scores: mental and physical health scores. The eight health component scales that can be computed from the questionnaire are physical function, role-physical, bodily pain, general health, vitality, role-emotional, mental health and social functioning.|12 months|From the 275 subjects that were eligible for the 12-Month Follow-Up, data for the Quality of Life Analysis were available for 265 subjects||units on a scale||Standard Deviation|Mean
836279|NCT01292928|Other Pre-specified|Walking Improvement (Distance) Assessed by 6 Minute Hall Walk|Assessment of walking improvement (distance) by the administration of the 6 Minute Walk Test (6MWT). Participants were asked to walk for as long as they could; up to 6 minutes.|12 months|From the 275 subjects that were eligible for the 12-Month Follow-Up, data for the Walking Improvement Assessed by 6 minute Hall Walk Analysis were available for 246 subjects||meters||Standard Deviation|Mean
836280|NCT01292928|Other Pre-specified|Walking Improvement (Time) Assessed by 6 Minute Hall Walk|Assessment of walking improvement (time) by the administration of the 6 Minute Walk Test (6MWT). Participants were asked to walk for as long as they could; up to 6 minutes.|12 months|From the 275 subjects that were eligible for the 12-Month Follow-Up, data for the Walking Improvement Assessed by 6 minute Hall Walk Analysis were available for 246 subjects||minutes||Standard Deviation|Mean
836281|NCT01292928|Other Pre-specified|Walking Improvement Assessed by the Walking Impairment Questionnaire|The Walking Impairment Questionnaire (WIQ) is a validated functional assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.|12 months|From the 275 subjects that were eligible for the 12-Month Follow-Up, data for the Walking Improvement assessed by the Walking Impairment Questionnaire were available for 265 subjects||units on a scale||Standard Deviation|Mean
836282|NCT01292928|Other Pre-specified|Rate of Hemodynamic Improvement|"The Ankle-Brachial Index (ABI) is the ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm.
Hemodynamic Improvement: Increases in ABI of ≥ 0.10 or to an ABI ≥ 0.90 as compared to pre-procedure without the need for repeat TLR.
Hemodynamic Improvement (Including TLR): Increases in ABI of ≥0.10 or to an ABI ≥0.90 as compared to pre-procedure including TLR."|12 months|278 subjects were included in the Rate of Hemodynamic Improvement Analysis (275 subjects eligible for the 12-Month Follow-Up + 3 subjects with TLR)||percentage of limbs|limbs||Number
836283|NCT01292928|Other Pre-specified|Rutherford Classification|"Class 0: Asymptomatic
Class 1: Mild claudication
Class 2: Moderate claudication
Class 3: Severe claudication
Class 4: Ischemic rest pain
Class 5: Minor tissue loss – nonhealing ulcer, focal gangrene with diffuse pedal edema
Class 6: Major tissue loss – extending above metatarsal (MT) level
Rate of Primary Sustained Clinical Improvement: an improvement in Rutherford classification of one or more categories as compared to pre-procedure without the need for repeat TLR.
Rate of Secondary Sustained Clinical Improvement: an improvement in Rutherford classification of one or more categories as compared to pre-procedure including those subjects with repeat TLR.
Rate of Clinical Deterioration: downgrade in Rutherford classification of one or more categories as compared to pre-procedure"|12 months|From the 275 subjects that were eligible for the 12-Month Follow-Up, data for the Rutherford Classification Analysis was available for 263 subjects||percentage of participants|||Number
836284|NCT01292928|Other Pre-specified|Stent Fracture Rate|"Vascular InterVentional Advances (VIVA) definitions:
Grade 0: No strut fractures
Grade I: single strut fracture
Grade II: multiple strut fractures
Grade III: stent fracture(s) with preserved alignment of the components
Grade IV: stent fracture(s) with mal-alignment of the components
Grade V: stent fracture(s) in a trans-axial spiral configuration"|12 months|From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Stent Fracture Analysis were available for 250 subjects||percentage of stents|stents||Number
836285|NCT01292928|Other Pre-specified|Assisted Primary Patency|Assisted primary patency is the percentage of lesions without TLR and those with TLR (not due to complete occlusion or bypass) that reach a time point without restenosis.|12 months|From the 275 subjects that were eligible for the 12-Month Follow-Up, data for the Assisted Primary Patency Analysis was available for 256 subjects||percentage of lesions||95% Confidence Interval|Number
836286|NCT01292928|Other Pre-specified|Primary Patency|Primary patency is the percentage of lesions (target stented segments) that reach a time point without a hemodynamically significant stenosis assessed by Duplex Ultrasound (DUS) and without Target Lesion Revascularization (TLR) or bypass of the target lesion.|12 months|From the 275 subjects that were eligible for the 12-Month Follow-Up, data for the Primary Patency Analysis was available for 268 subjects/lesions||percentage of lesions|Lesions|95% Confidence Interval|Number
836287|NCT01292928|Other Pre-specified|Technical and Procedural Success|"Technical success: ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30%
Procedural success: technical success with no MAEs within 24 hours of the procedure"|Up to 24 hours after the procedure|||percentage of participants||95% Confidence Interval|Number
836288|NCT01292928|Secondary|Secondary Safety Endpoint and Components|The secondary safety endpoint assesses the occurrence of Major Adverse Events (MAEs) through 30 days. MAEs will include all causes of death, target limb major amputation and/or target lesion revascularization through 1 month|1 month|From the 299 enrolled subjects, data for the Secondary Safety Endpoint was available for 297 subjects||percentage of participants||95% Confidence Interval|Number
836289|NCT01292928|Primary|Co-Primary Efficacy Endpoints|"The co-primary efficacy endpoints assess vessel primary patency at 12 months post-procedure.
The co-primary efficacy analysis (1) will assess vessel primary patency in stented segments intended to be treated with core matrix stents (20 to 150 mm).
The co-primary efficacy analysis (2) will assess vessel primary patency in stented segments intended to be treated with the entire stent matrix (20 to 200 mm)."|12 months|From the 275 subjects that were eligible for the 12-Month Follow-Up, data for the Co-Primary Efficacy Endpoints were available for 268 subjects||percentage of participants||95% Confidence Interval|Number
836345|NCT01294397|Secondary|Time to Maximum Serum Concentration (Tmax) of Etanercept||Day 1 and day 22; at each time point samples were taken predose and 2, 3, 4, 5, 6 and 8 days postdose.|Participants with available Tmax data||days||Full Range|Median
836290|NCT01292928|Primary|Primary Safety Endpoint and Components|The safety endpoint assesses the occurrence of Major Adverse Events (MAEs) defined as all causes of death through 1 month, target limb major amputation through 12 months and/or target lesion revascularization through 12 months|1 month for death, 12 months for target limb major amputation , and target lesion revascularization|From the 275 subjects that were eligible for the 12-Month Follow-Up, data for the Primary Safety Endpoint were available for 268 subjects.||percentage of participants||95% Confidence Interval|Number
836291|NCT01293825|Secondary|Quality of Life Score as Measured by 12-item Short Form Health Survey|Scale Range: 1-99th percentile score. Higher scores indicate better outcomes.|Week 16|||units on a scale||Standard Deviation|Mean
836292|NCT01293825|Secondary|Body Weight||Week 16|||lbs||Standard Deviation|Mean
836293|NCT01293825|Secondary|Young Mania Rating Scale|Scale Range: 0-60. Lower scores indicate better outcomes.|Week 16|||units on a scale||Standard Deviation|Mean
836294|NCT01293825|Secondary|Montgomery Asberg Depression Rating Scale|Scale Range: 0-60. Lower scores indicate better outcomes.|Week 16|||units on a scale||Standard Deviation|Mean
836295|NCT01293825|Secondary|Social and Occupational Functioning Scale|Life and Work Functional status will be evaluated using the Social and Occupational Functioning Scale (SOFAS), which is derived from the GAF (Global Assessment of Functioning). The GAF is a 100-point single-item scale which measures global functioning of psychiatric patients and is widely utilized in clinical studies involving Seriously Mentally Ill patients (Jones 1995). The reliability of the GAF ranges from 0.62-0.82. Higher scores indicate improved outcomes.|Week 16|||units on a scale||Standard Deviation|Mean
836296|NCT01293825|Secondary|Global Psychopathology Score as Measured by Clinical Global Impressions|Global psychopathology will be measured with the Clinical Global Impressions (CGI) (Guy 1976) a widely used scale which evaluates illness severity on a 1 to 7 point continuum. Severity of illness ratings on the CGI have reported reliability scores ranging from 0.41-0.66 (Guy 1976). Lower scores indicate improved outcomes.|Week 16|||units on a scale||Standard Deviation|Mean
836297|NCT01293825|Secondary|Attitude Toward Medication Score as Measured by the Drug Attitude Inventory|Ten item inventory taken by the participant with a Scale Range: 0-10. Higher scores indicate improved outcomes.|Week 16|||units on a scale||Standard Deviation|Mean
836298|NCT01293825|Secondary|Treatment Adherence Score as Measured by the Morisky Rating Scale|Four item inventory taken by participant with Scale Range: 0-4. Lower scores indicate improved outcomes.|Week 16|||units on a scale||Standard Deviation|Mean
836299|NCT01293825|Primary|Treatment Non-adherence Percentage as Measured by the Tablet Routines Questionnaire (TRQ)|Scale Range: 0-100%. The score represents percentage of time that required medication doses were missed. Higher scores indicate lower medication adherence.|Week 16|||Percentage of doses||Standard Deviation|Mean
836300|NCT01293968|Secondary|The Effect of Ibuprofen, Diphenhydramine, Aluminium MgS and Diphenhydramine and Aluminium MgS in Decreasing the Pain Level and Burning Sensation|pain sensation was measured by VAS (Visual Analogue Scale) 4 days after the consumption of the solutions and the results of both drugs was analyzed|4 days after the solution consumption||||||
836301|NCT01293968|Primary|Effect of Ibuprofen, Diphenhydramine and Aluminium MgS Measured on Decrease in Pain Level and Burning Sensation|pain sensation was measured by VAS (Visual Analogue Scale, a scaled ruler which the zero point displays the zone of lack of pain and the 10th point was considered as the zone of maximum pain)) 4 days after the consumption of the solution|four days after the start of the study|The intention of the study is to study the effects of Ibuprofen, Diphenhydramine and Aluminium MgS in decreasing the signs of RAS||scores in Visual Analogue Scale||95% Confidence Interval|Mean
836302|NCT01294046|Secondary|Relief of Migraine-associated Symptoms, e.g. Nausea/Vomiting, Photophobia, Phonophobia|Presence or absence of nausea, vomiting, photophobia, and phonophobia will be assessed at baseline and after stimulation at 2 hours for each stimulation for each individual.|8.5 months|No data were collected from this entire study, so no data were analyzed.|||||
836303|NCT01294046|Secondary|Implantation and Stimulation Related Adverse Events|As noted above, we are using the FDA-approved categorical scale used for all migraine regulatory trials since 1992. This is a 4 point categorical scale where 0= no pain, 1= mild headache pain, 2= moderate pain, and 3= severe pain. Pain free is defined as the subject moving from pain intensity of 2 to 3 at baseine to 0 by 2 hours after stimulation.|8.5 months|No data were collected from this entire study, so no data were analyzed.|||||
836304|NCT01294046|Secondary|Average Per Subject Reduction in Migraine Days/Month|During the baseline period, subjects will record the number of migraine days (as defined by the FDA-approved International Classification of Headache Disorders, 2d Edition definition of migraine with and without aura) during the month. The primary endpoint for this phase is a reduction in the number of migraine days during the last month of the study as compared to the baseline month.|8.5 months|No data were collected from this entire study, so no data were analyzed.|||||
836305|NCT01294046|Secondary|Stimulation Related Adverse Events|Number of Participants with Adverse Events as a Measure of Safety and Tolerability|8.5 months|No data were collected from this entire study, so no data were analyzed.|||||
836306|NCT01294046|Secondary|Migraine Disability Assessment Scale (MIDAS) at Study Conclusion Compared With Baseline|The Migraine Disability Assessment Scale (MIDAS) is a validated tool that assesses how many days in the last 3 months a patient had at least 50% disability at work, home, school, or recreational activities due to migraine. MIDAS will be assessed at baseline and after study conclusion.|8.5 months|No data were collected from this entire study, so no data were analyzed.|||||
836307|NCT01294046|Secondary|Headache Impact Test (HIT-6) Compared With Baseline|The Headache Impact Test -6 (HIT-6) is a validated tool for evaluating headache impact and disability across 6 domains, which will be recorded at baseline and at study conclusion.|8.5 months|No data were collected from this entire study, so no data were analyzed.|||||
836308|NCT01294046|Secondary|Acute Migraine Medication Use|During the baseline period, subjects will record their acute as-needed migraine relief medication use for each attack by drug, dose, route, and frequency. A secondary endpoint for this phase is a reduction in acute migraine medication usage for each attack for drug, dose, route, and frequency during the last month of the study as compared to the baseline month.|8.5 months|No data were collected from this entire study, so no data were analyzed.|||||
836346|NCT01294397|Primary|Maximum Observed Serum Concentration (Cmax) of Etanercept||Day 1 and day 22; at each time point samples were taken predose and 2, 3, 4, 5, 6 and 8 days postdose.|Participants with available Cmax data||μg/mL||Standard Deviation|Mean
836310|NCT01294046|Secondary|Migraine Free at 2 Hours|Each migraine will be categorized as meeting the endpoint of migraine free if there is a reduction in the migraine grade to 0 for pain with no nausea, photophobia and phonophobia at 2 hours after initiation of stimulation.|8.5 Months|No data were collected from this entire study, so no data were analyzed.|||||
836311|NCT01294046|Primary|Migraine Relief at 2 Hours Post Stimulation|Pain is rated at stimulation and 2 hours after stimulation initiated based on four point categorical scale, FDA-approved, where 0 = no headache pain, 1= mild pain, 2 = moderate pain, 3 = severe pain. This scale has been used since 1991 for all regulatory submission migraine protocols. Each migraine is categorized in a binary fashion as meeting the endpoint at 2 hours. Migraine relief or Pain relief is defined as moving from pain levels of 3 to 2 down to 1 or 0.|8.5 Months|No data were collected from this entire study, so no data were analyzed.|||||
836312|NCT01294150|Secondary|Sexual Function|Over the 12 month follow-up period, the proportion of UroLift patients who experience de novo sustained erectile dysfunction and retrograde ejaculation will be reported. Control subjects are not included in this analysis since controls could crossover option opened at 3 months.|12 Months|||% of Subjects|||Number
836313|NCT01294150|Primary|Mean UroLift Improvement in IPSS at 12 Months|The International Prostate Symptom Score (IPSS) is a standardized 8 question (7 symptom questions + 1 quality of life question) written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH). Those patients scoring 7 or below are generally considered mildly symptomatic, whereas 20 or above is considered severely symptomatic. To meet co-primary effectiveness endpoint, the lower bound of a one-sided 97.5% confidence interval of IPSS mean percent change from baseline at Month 12 in the UroLift group must be greater than or equal to 30%.|12 months|||% IPSS Score Improvement||97.5% Confidence Interval|Number
836314|NCT01294150|Primary|Comparison of IPSS for Efficacy|"The UroLift system will be considered superior to the Control if the mean International Prostate Symptom Score (IPSS) change (improvement) from baseline at 3 months demonstrates a minimum statistical margin of 25% compared to mean improvement from baseline for cystoscopy alone.
The IPSS is an 8 question (7 symptom questions + 1 quality of life question) written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH).
SCORING:
0-7 Mildly symptomatic 8-19 Moderately symptomatic 20-35 Severely symptomatic"|3 month|||IPSS total score||Standard Deviation|Mean
836315|NCT01294150|Primary|Collection of Post-treatment Catheterization for Safety|The primary safety endpoint is an assessment of the rate of extended post-operative urinary catheterization in the subjects randomized to the UroLift group of the study in the ITT group. The extended post-operative urinary catheterization rate is defined as including those subjects who required catheterization within the first 3 days as part of post-operative management for inability to void, and required the catheter for more than 7 days. 2/140 met this endpoint.|Cath within first 3 days post-procedure which extended beyond 7 days, up to 12 days|||participants|||Number
836316|NCT01294163|Primary|Log-transformed Blood Level of Troponin I|Blood level of troponin I measured by a central laboratory|Sampling performed 24 hours after the end of the surgical procedure|The non-inferiority comparison between Xenon and Sevoflurane was repeated using log-transformed blood troponin levels on the PP Set.||ng/mL||95% Confidence Interval|Least Squares Mean
836317|NCT01294163|Secondary|Presence of Absence of Adverse Events, Including Myocardial Infarction||7 days||||||
836318|NCT01294163|Secondary|Vital Signs||7 days||||||
836319|NCT01294163|Secondary|ECG Abnormalities||7 days||||||
836320|NCT01294163|Secondary|Clinical Laboratory Tests||7 days||||||
836321|NCT01294163|Secondary|Presence or Absence of Postoperative Delirium|Confusion Assessment Method|7 days||||||
836322|NCT01294163|Secondary|Haemodynamic Profile|Monitoring of heart rate, arterial blood pressure, central venous pressure.|4 hours||||||
836323|NCT01294163|Secondary|Arterial Oxygen Saturation|Arterial blood gases|4 hours||||||
836324|NCT01294163|Secondary|Depth of Anaesthesia|On-line monitoring of depth of anaesthesia from bi-spectral electroencephalogram analysis (BIS monitor)|4 hours||||||
836325|NCT01294163|Primary|Blood Level of Troponin I|Blood level of troponin I measured by a central laboratory|Sampling performed 24 hours after the end of the surgical procedure|The primary analysis was a non-inferiority comparison between Xenon and Sevoflurane and was performed on the Per Protocol (PP) Set composed of all randomised and treated patients with no major protocol deviations during the study.||ng/mL||95% Confidence Interval|Least Squares Mean
836326|NCT01294228|Primary|The Efficacy of the Triage Neutraphil-Gelatinase Associated Lipocalin (NGAL) Test as an Aid in the Diagnosis of Acute Kidney Injury (AKI) in an All-comers ICU Setting.|The efficacy of the Triage Neutraphil-Gelatinase Associated Lipocalin (NGAL) Test as an aid in the diagnosis of acute kidney injury (AKI) in an all-comers ICU setting. Final AKI diagnoses were established by an adjudication committee.|Prior to or within 72 hours.|Study participants who had both an adjudicated AKI diagnosis and an evaluable T=0 (study enrollment) blood collection and associated test results.||Probability||95% Confidence Interval|Number
836327|NCT01294306|Secondary|Median Overall Survival|Estimated using the product-limit method of Kaplan and Meier. Event defined as death due to any cause.|Up to 2 Years|||Months||95% Confidence Interval|Median
836328|NCT01294306|Secondary|Toxicity of Akt Inhibitor MK2206 Plus Erlotinib Hydrochloride|Toxicities of Grade 3 or higher Attributed to Akt inhibitor MK2206 plus erlotinib hydrochloride, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0|Time Frame: Up to 2 years|||participants|||Number
836329|NCT01294306|Secondary|Median Progression-free Survival|Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Up to 2 years|||Months||95% Confidence Interval|Median
836330|NCT01294306|Primary|Objective Response|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response = CR + PR|Up to 2 years|||percentage of subjects|||Number
836331|NCT01294306|Primary|Disease-control Rate|Disease-control rate defined as response rate + stable disease at 12 weeks. Stable disease must have been achieved for 12 weeks or longer. Response evaluated per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.|At 12 weeks|||percentage of subjects|||Number
836332|NCT01294371|Secondary|Participants With Estrogen Deficiency Symptoms|"Estrogen deficiency symptoms include:
hot flashes,
headaches,
palpitations at rest,
insomnia,
fluctuation of mood."|6 months|Full Analysis Set||participants|||Number
836333|NCT01294371|Secondary|Percent Compliance to Treatment With Leuprorelin|Compliance to treatment was calculated as the number of leuprorelin doses administered / number of doses prescribed * 100.|6 months|Participants who received at least one dose of leuprorelin.||percent compliance||Standard Deviation|Mean
836334|NCT01294371|Primary|Percentage of Participants Administered Add-back Therapy During a 6-month Course of Leuprorelin Treatment|The percentage of participants who received hormone add-back therapy or non-hormone add-back therapy to reduce estrogen deficiency symptom, following local guidelines or therapeutic recommendations, during the 6-month treatment period with leuprorelin.|6 months|Full Analysis Set included all all patients who had signed the personal authorization form and who administered at least one dose of leuprorelin and who had attended at least one post-baseline visit.||percentage of participants|||Number
836335|NCT01294384|Secondary|Change From Baseline in Schirmer Test|The Schirmer Test measures the rate of the secretion of tears produced by the eye over 5 minutes. The results indicate the presence of dry eye where Normal=greater than or equal to 10 millimeters (mm) of tears and Dry Eye=less than 10 mm of tears). The smaller the number, the more severe the dry eye. A positive number change from baseline indicated an increase in tears (improvement).|Baseline, Day 90|Participants from the Intent-to-Treat population, that included all randomized participants.||mm||Standard Deviation|Mean
836336|NCT01294384|Secondary|Change From Baseline in Conjunctival Staining|The conjunctiva is the clear membrane covering the white surface of the eye. Conjunctival staining following ocular administration of lissamine green dye was graded using a 6-point scale where 0=no staining to 5=severe staining over 6 areas of the white part of the eye for a minimum score of 0 and a maximum score of 30. The higher the score, the worse the dry eye condition. A negative number change from baseline represented a decrease in the severity of conjunctival staining (improvement).|Baseline, Day 90|Participants from the Intent-to-Treat population, that included all randomized participants.||Score on a scale||Standard Deviation|Mean
836337|NCT01294384|Secondary|Change From Baseline in Corneal Staining|The cornea is the transparent front part of the eye which covers the iris and pupil. Corneal staining following administration of fluorescein dye in the eye is graded using a 6-point scale where 0=no staining to 5=severe staining over 5 areas of the clear central part of the eye for a minimum score of 0 and maximum score of 25. The higher the grade score, the worse the dry eye condition. A negative number change from baseline represented a decrease in corneal staining (improvement).|Baseline, Day 90|Participants from the Intent-to-Treat population, that included all randomized participants.||Score on a scale||Standard Deviation|Mean
836338|NCT01294384|Secondary|Change From Baseline in Tear Break-Up Time (TBUT)|TBUT is defined as the time (seconds) required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A positive number change from Baseline indicated improvement.|Baseline, Day 90|Participants from the Intent-to-Treat population, that included all randomized participants.||Seconds||Standard Deviation|Mean
836339|NCT01294384|Secondary|Percentage of Participants Much Better or Better in Near Visual Acuity (High Contrast)|Near Visual Acuity was determined using the number of letters read correctly on a high contrast eye chart (black letters on a white background). An increase in the number of letters read correctly indicated improvement. Much Better is defined as an increase of 10 or more letters read correctly at Day 90 compared to the worse eye at Baseline. Better is defined as an increase of 5 to 9 letters read correctly at Day 90 compared to the worse eye at Baseline.|Baseline, Day 90|Participants from the Intent-to-Treat population, that included all randomized participants.||Percentage of participants|||Number
836340|NCT01294384|Secondary|Percentage of Participants Much Better or Better in Near Visual Acuity (Low Contrast)|Near Visual Acuity was determined using the number of letters read correctly on a low contrast eye chart (gray letters on a white background). An increase in the number of letters read correctly indicated improvement. Much Better is defined as an increase of 10 or more letters read correctly at Day 90 compared to the worse eye at Baseline. Better is defined as an increase of 5 to 9 letters read correctly at Day 90 compared to the worse eye at Baseline.|Baseline, Day 90|Participants from the Intent-to-Treat population, that included all randomized participants.||Percentage of participants|||Number
836341|NCT01294384|Secondary|Change From Baseline in Visual Analog (VAS) Symptom Scale: Dryness|The participant rated the severity of their dry eye symptom: dryness using a VAS scale. Participants put a mark on a 100 millimeter line where 0 (far left on the line)=no symptoms to 100 (far right on the line)=most severe symptoms.|Baseline, Day 90|Participants from the Intent-to-Treat population, that included all randomized participants.||millimeters||Standard Deviation|Mean
836342|NCT01294384|Primary|Change From Baseline in Ocular Surface Disease Index© (OSDI) Score|The OSDI is a questionnaire consisting of 12 questions assessing severity of dry eye using a 5-point scale where 0=none of the time to 4=all of the time. The total score is the sum of the individual scores normalized (standardized) to a severity scale of 0=no symptoms (best score) to 100=maximum severity (worst score). A negative change from Baseline indicated improvement.|Baseline, Day 90|Participants from the Intent-to-Treat population, that included all randomized participants.||Score on a scale||Standard Deviation|Mean
836343|NCT01294397|Secondary|Percent Change From Baseline in Serum C-telopeptide (sCTx) Concentrations||Baseline (Day 8) and Days 22, 29, 85, and 176|Participants with available data at baseline (19) and each time point (indicated by n)||percent change||Inter-Quartile Range|Median
836344|NCT01294397|Secondary|Serum Denosumab Concentration||Prior to etanercept and denosumab dose administrations, as applicable, on days 8, 22, and 29|Participants with available data||μg/mL||Standard Deviation|Mean
836347|NCT01294397|Primary|Area Under the Serum Concentration-time Curve From 0 to 168 Hours (AUC0-168) for Etanercept|The AUC0-168 of etanercept was measured when administered alone (assessed from day 1) and after administration with denosumab (assessed from day 22, 14 days after denosumab dosing, close to the time of the maximum observed denosumab serum concentration and corresponding to a time approximately 1 week after maximal pharmacodynamic (PD) effects of denosumab are attained).|Day 1 and day 22; at each time point samples were taken predose and 2, 3, 4, 5, 6 and 8 days postdose.|Participants with available AUC data||day*μg/mL||Standard Deviation|Mean
836348|NCT01294423|Secondary|Adjusted Mean Change in Body Weight|To compare the change from baseline in total body weight achieved with each dose of dapagliflozin versus placebo after 24 weeks double-blind treatment.|From Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values||kg||95% Confidence Interval|Least Squares Mean
836349|NCT01294423|Secondary|Adjusted Mean Change in Fasting Plasma Glucose (FPG)|To compare the change from baseline in fasting plasma glucose (FPG) achieved with each dose of dapagliflozin versus placebo after 24 weeks double-blind treatment.|From Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values||mg/dL||95% Confidence Interval|Least Squares Mean
836350|NCT01294423|Primary|Adjusted Mean Change in HbA1c Levels|To compare change from baseline in HbA1c achieved with each dose of dapagliflozin versus placebo after 24 weeks double-blind treatment.|From Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values||Percent||95% Confidence Interval|Least Squares Mean
836351|NCT01294436|Other Pre-specified|Mean Change in Body Weight|To evaluate the efficacy of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in body weight|Baseline to Week 52|Full Analysis Set, participants with non-missing baseline and week 52 (LOCF) value||kg||95% Confidence Interval|Mean
836352|NCT01294436|Other Pre-specified|Mean Change in HbA1c Levels|To evaluate the efficacy of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in HbA1c|Baseline to Week 52|Full Analysis Set, participants with non-missing baseline and week 52 (LOCF) value||Percent||95% Confidence Interval|Mean
836353|NCT01294436|Primary|Mean Change in Seated Systolic Blood Pressure|To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in blood pressure|Baseline to Week 52|Safety Analysis Set, participants with non-missing baseline and week 52 values||mmHg||Standard Deviation|Mean
836354|NCT01294436|Primary|Mean Change in Seated Diastolic Blood Pressure|To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in blood pressure|Baseline to Week 52|Safety Analysis Set, participants with non-missing baseline and week 52 values||mmHg||Standard Deviation|Mean
836355|NCT01294436|Primary|Mean Change in Seated Heart Rate|To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in pulse|Baseline to Week 52|Safety Analysis Set, participants with non-missing baseline and week 52 values||beats per minute (bpm)||Standard Deviation|Mean
836356|NCT01294436|Primary|Mean Change in Serum Uric Acid|To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in serum uric acid|Baseline to Week 52|Safety Analysis Set, participants with non-missing baseline and week 52 values||mg/dL||Standard Error|Mean
836357|NCT01294436|Primary|Mean Change in Magnesium|To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in magnesium (1 mEq/L equivalent to 0.50 mmol/L)|Baseline to Week 52|Safety Analysis Set, participants with non-missing baseline and week 52 values||mEq/L||Standard Error|Mean
836358|NCT01294436|Primary|Mean Change in Blood Urea Nitrogen (BUN)|To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in blood urea nitrogen|Baseline to Week 52|Safety Analysis Set, participants with non-missing baseline and week 52 values||mg/dL||Standard Error|Mean
836359|NCT01294436|Primary|Mean Change in Aspartate Aminotransferase (AST)|To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in aspartate aminotransferase|Baseline to Week 52|Safety Analysis Set, participants with non-missing baseline and week 52 values||U/L||Standard Error|Mean
836360|NCT01294436|Primary|Mean Change in Alanine Aminotransferase (ALT)|To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in alanine aminotransferase|Baseline to Week 52|Safety Analysis Set, participants with non-missing baseline and week 52 values||U/L||Standard Error|Mean
836361|NCT01294436|Primary|Mean Change in Hematocrit|To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in hematocrit|Baseline to Week 52|Safety Analysis Set, participants with non-missing baseline and week 52 values||Percent||Standard Error|Mean
836362|NCT01294436|Primary|Proportion of Participants With At Least One Episode of Hypoglycemia|To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to occurrence of hypoglycemia|Long-term treatment up to 52 weeks|Safety Analysis Set||Percentage of participants|||Number
836363|NCT01294436|Primary|Proportion of Participants With Serious Adverse Events|To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to serious adverse events|Long-term treatment up to 52 weeks|Safety Analysis Set||Percentage of participants|||Number
836364|NCT01294436|Primary|Proportion of Participants With Adverse Events|To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to adverse events|Long-term treatment up to 52 weeks|Safety Analysis Set||Percentage of participants|||Number
836365|NCT01294449|Primary|All-Cause Mortality|Outcome measured for total population. Not broken down by indication received.|5 years|||participants|||Number
836366|NCT01294462|Secondary|Composite of All-cause Mortality, MI or Stroke|Time to first occurrence of any event from the composite of death from any causes, Myocardial Infarction (MI) and stroke (adjudicated by an ICEC). 1-year event rate (%) estimated via Kaplan-Meier method.|Ongoing up to 12 months|Full Analysis set which includes all randomized patients with available post-randomization efficacy data||Percent probability|||Number
836367|NCT01294462|Secondary|Major and Minor Bleeding|Time to first occurrence of any major or minor bleeding event (adjudicated by an independent Clinical Endpoint Committee (ICEC)). 1-year event rate (%) estimated via Kaplan-Meier method.|Ongoing up to12 months|Safety analysis set which includes all patients who received randomized treatment with available post-treatment safety data||Percent probability|||Number
836368|NCT01294462|Primary|Major Adverse Cardiac Events (MACE)|Time to first occurrence of any event from the composite of death from vascular causes, Myocardial Infarction (MI) and stroke (adjudicated by an ICEC). 1-year event rate (%) estimated via Kaplan-Meier method.|Ongoing up to 12 months|Full Analysis set which includes all randomized patients with available post-randomization efficacy data||Percent probability|||Number
836369|NCT01294462|Primary|Major Bleeding|Time to first occurrence of any major bleeding event (adjudicated by an independent Clinical Endpoint Committee (ICEC)). 1-year event rate (%) estimated via Kaplan-Meier method.|Ongoing up to12 months|Safety analysis set which includes all patients who received randomized treatment with available post-treatment safety data||Percent probability|||Number
836370|NCT01294514|Post-Hoc|Calculate Covidien Respiration Rate Software Accuracy as Mean Error +/- Standard Deviation|The Covidien Nellcor Respiration Rate Software shall calculate respiration rate as mean error of +/- standard deviation.|Overall average|One participant was excluded from the data analysis based on cardiac arrhythmia||Breaths Per Minute (BrPM)||Standard Deviation|Mean
836371|NCT01294514|Secondary|The Covidien Nellcor Respiration Rate Software Shall Calculate Respiration Rate With a Root Mean Square Difference (RMSD) of < 3 Breaths Per Minute Compared With a End-Tidal Carbon Dioxide Waveforms, With 95% Confidence.|"The data used for analysis consisted of multiple simultaneous measures of RR_TTI, RR_V1.0 and RR_EtCO2 for each subject. Given N sets of simultaneous RR values for each of P patients, the simultaneous RR values were used to calculate a pair of RMSD values for each subject.
The two RMSD values, RMSDRR_V1.0_vs_EtCO2, and RMSDTTI_vs_EtCO2, quantify the mean absolute difference in simultaneous estimates of respiratory rate between RR_V1.0 compared with RR_EtCO2 and RR_TTI compared with RR_EtCO2, respectively for the subjects with 95% confidence of mean ± 3.38 BrPM. The Measure type is Number and represents the RMSD of Covidien Nellcor Respiration Rate Software"|Participants were monitored on average of 30 minute periods|One participant was excluded from the data analysis based on cardiac arrhythmia||Breaths Per Minute (BrPM)|||Number
836372|NCT01294514|Primary|The Covidien Nellcor Respiration Rate Software Shall Determine Respiration Rate Measured as Mean and Standard Deviation With Accuracy That is Non-inferior to Predicate Device.|Mean and standard deviations of respiration rates collected from healthy volunteers were compared between Covidien Respiration Rate Software, Transthoracic Impedance and Overscored End-Tidal Carbon Dioxide Waveforms. Each volunteer served as its own control.|Participants were monitorerd on average of 30 minute period|One participant was excluded from the analysis based on cardiac arrhythmia||Breaths Per Minute (BrPM)||Standard Deviation|Mean
836373|NCT01294553|Secondary|Number of Participants With the Indicated Unexpected Adverse Events|Unexpected adverse events are defined as those that were not described in the locally approved label by the Korean Food and Drug Administration (KFDA) at the time of surveillance completion.|41.4 weeks|ITT Population||participants|||Number
836374|NCT01294553|Secondary|Number of Participants With a Serious Adverse Event|"A serious adverse event is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or results in prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. For a list of all serious adverse events occurring during the course of the study, please see the table entitled Serious Adverse Events in the Adverse Event section of the results record."|41.4 weeks|ITT Population||participants|||Number
836375|NCT01294553|Primary|Number of Participants With an Adverse Event|"An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. For a list of all adverse events occurring during the course of the study, please see the table entitled Other (non-serious) adverse events in the Adverse Event section of the results record."|41.4 weeks|Intent-to-Treat (ITT) Population: all participants who had been administered the investigational drug at least once and had undergone all safety assessments||participants|||Number
836376|NCT01294592|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) Starting Post-randomization|A post-randomization adverse event is defined as an event with an onset on or after the randomization date or with a missing onset date. An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations. Refer to the general non-serious AE/SAE module for a list of non-serious AEs (occurring at a frequency threshold of >=5%) and SAEs.|Up to 2 years|ITT Population||Participants|||Number
836377|NCT01294592|Secondary|Exposure to Study Drug|Study drug exposure (days) = treatment stop date - treatment start date + 1. Participants in the Watchful Waiting Escalated=Yes subgroup could have been escalated to study drug at any time during the study. Therefore, it is possible that participants were exposed to tamsulosin for a shorter length of time than participants in the dutasteride plus tamsulosin group.|Up to 2 years|Treated Subjects Population: all participants starting protocol pharmacological treatment, either dutasteride plus tamsulosin or (escalated to) tamsulosin, as indicated by a nonmissing electronic Case Report Form treatment start date||days||Standard Deviation|Mean
836378|NCT01294592|Secondary|Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach|"The PPST questionnaire consists of two questions (asked to determine how satisfied participants are with the treatment received) and was administered at Baseline and all post-Baseline visits. Question 2 was: Would you ask your doctor for the treatment you received in this study? There were three possible responses, including: Yes, No, and Not sure. Response categories included Yes and No or Not Sure, created by grouping together No and Not sure. The LOCF method involves bringing forward the last non-missing post-Baseline assessment for a participant with missing data and/or for a participant who discontinued from the study."|Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24|ITT Population. Participants with data available at the specified time point or using LOCF (post-Baseline) were summarized.||Participants|||Number
836379|NCT01294592|Secondary|Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach|"The PPST questionnaire consists of two questions (asked to determine how satisfied participants are with the treatment received) and was administered at Baseline and all post-Baseline visits. Question 1 was: Overall, how satisfied are you with the treatment and its effect on your urinary problems? There were seven possible responses, including: very satisfied, satisfied, somewhat satisfied, neutral, somewhat dissatisfied, dissatisfied, and very dissatisfied. Response categories were created by grouping together very satisfied, satisfied, and somewhat satisfied responses into the category of Any Satisfaction (AS), and separately grouping neutral, somewhat dissatisfied, dissatisfied, and very dissatisfied responses into the category of Neutral or Any Dissatisfaction (N/AD). The LOCF method involves bringing forward the last non-missing post-Baseline assessment for a participant with missing data and/or for a participant who discontinued from the study."|Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24|ITT Population. Participants with data available at the specified time point or using LOCF (post-Baseline) were summarized.||Participants|||Number
836380|NCT01294592|Secondary|Number of Participants Who Had Any BPH-related Surgery, Who Had the Indicated Type of Surgery, Who Had 2 BPH-related Surgeries, and Who Had >=3 BPH-related Surgeries|BPH-related surgery was summarized for events occurring on or after the date of randomization. The number of participants who had any BPH-related surgery, the indicated type of surgery, and multiple surgeries was summarized by treatment. Type of surgery data (cystoscopy, transurethral resection of the prostate [TURP], and prostatectomy) are presented in terms of the first-occurring BPH-related surgery after randomization. It was possible for a single participant to have multiple surgeries.|Up to Month 24|ITT Population||Participants|||Number
836381|NCT01294592|Secondary|Number of Participants With the Indicated First-occurring Component of Clinical Progression (CP) of BPH|"CP of BPH is a composite of five endpoints assessed through the end of the study, including: symptom progression (symptom deterioration by IPSS >=3 points from Baseline [Visit 2]); acute urinary retention (AUR) related to BPH; incontinence (overflow or urge) related to BPH; recurrent urinary tract infection (UTI) or urosepsis related to BPH; renal insufficiency related to BPH (a single >=50% rise from Baseline serum creatinine and a total value >=1.5 milligrams/deciliter). The number of participants with CP of BPH, the number of participants with the indicated first-occurring component of CP of BPH, the number of participants with two simultaneously first-occurring components (Tied for first component), and the number of participants with multiple first-occurring components were summarized by treatment group."|Up to Month 24|ITT Population||Participants|||Number
836382|NCT01294592|Secondary|Number of Events of Clinical Progression (CP) of BPH|The number of participants with the first occurrence of clinical progression (CP) of BPH occurring on or after the randomization date are summarized by treatment and year. Time is based on the date of the first-occurring CP event, and is relative to the randomization date. CP of BPH is a composite of five endpoints assessed through the end of the study, including: symptom deterioration by IPSS >=3 points from Baseline (Visit 2); acute urinary retention related to BPH; incontinence (overflow or urge) related to BPH; recurrent urinary tract infection (UTI) or urosepsis related to BPH; renal insufficiency related to BPH (a single >=50% rise from Baseline serum creatinine and a total value >=1.5 milligrams/deciliter). For components that required multiple episodes, the first of the multiple episodes was utilized in terms of timing.|Up to 2 years|ITT Population. Only those participants at risk for CP at the specified visit were analyzed.||Events|||Number
836383|NCT01294592|Secondary|Change From Baseline in the BPH-related Health Status (BHS) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach|Each participant was asked the following question “If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?”. This response was rated from 0 (“delighted”) to 6 (“terrible”). Change from Baseline in the BHS score was summarized by treatment group using the LOCF approach at each scheduled post-Baseline assessment. LOCF analysis involves bringing forward the last non-missing post-Baseline assessment for a participant with missing data and/or for a participant who discontinued from the study. Estimates are based on the adjusted means from the general linear model: Change from Baseline =Treatment + Cluster + Baseline Value. Baseline is defined as the Visit 2 value if it exists; otherwise, it is the latest of all Screening values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24|ITT Population. Participants with data available at the specified time point or using LOCF (post-Baseline) were summarized.||Scores on a scale||Standard Error|Least Squares Mean
836394|NCT01294644|Secondary|Change From Baseline in CR-SMFRS Score|"The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.
A negative change from Baseline indicates improvement."|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)|Intent-to-treat population with available data||units on a scale||Standard Deviation|Mean
836384|NCT01294592|Secondary|Change From Baseline in the BPH Impact Index (BII) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach|The BII is a 4-item questionnaire covering physical discomfort, worry, bother, and impact on usual activities, with a minimum score of 0 (best) and a maximum score (worst) of 13 points. Individual missing questionnaire responses were imputed, as applicable. Change from Baseline in the BII score was summarized by treatment group using the LOCF approach at each scheduled post-Baseline assessment. LOCF analysis involves bringing forward the last non-missing post-Baseline assessment for a participant with missing data and/or for a participant who discontinued from the study. Estimates are based on the adjusted means from the general linear model: Change from Baseline =Treatment + Cluster + Baseline Value. Baseline is defined as the Visit 2 value if it exists; otherwise, it is the latest of all Screening values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24|ITT Population. Participants with data available at the specified time point or using LOCF (post-Baseline) were summarized.||Scores on a scale||Standard Error|Least Squares Mean
836385|NCT01294592|Secondary|Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach|Symptom improvement was assessed using IPSS categorical changes from Baseline. Change from Baseline categories were summarized by treatment group using five improvement levels: >=1 point through >=5 points. IPSS percent change from Baseline was summarized using seven improvement levels: >0 percent, >=10 percent, >=20 percent, >=25 percent, >=30 percent, >=40 percent, and >=50 percent. Change in IPSS from Baseline was analysed using the LOCF method and is summarized for the following categories: >=2 points, >=3 points, and percent change >=25. The 7 items in the IPSS questionnaire quantitatively measure the level of urinary symptoms reported as a total IPSS. The total IPSS (sum of the first 7 items) can range from 0 to 35: mild (0 to 7), moderate (8 to 19), or severe (20 to 35).|Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24|ITT Population. Participants with data available at the specified time point or using LOCF (post-Baseline) were summarized. LOCF analysis involves bringing forward the last non-missing post-Baseline assessment for a participant with missing data and/or for a participant who discontinued from the study.||Participants|||Number
836386|NCT01294592|Primary|Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the Last Observation Carried Forward (LOCF) Approach|"The IPSS questionnaire is a 7-item self-administered questionnaire designed to quantify the following urinary symptoms: Question 1 (Q1), incomplete emptying; Q2, frequency; Q3, intermittency; Q4, urgency; Q5, weak stream; Q6, straining; Q7, nocturia. It has an additional, independent eighth question to assess change in BPH-related health status (BHS) and quality of life. BHS scores range from 0 to 6, where 0 indicates delighted and 6 indicates terrible. The 7 items in the IPSS questionnaire quantitatively measure the level of urinary symptoms reported as a total IPSS. The total IPSS (sum of the first 7 items) can range from 0 to 35: mild (0 to 7), moderate (8 to 19), or severe (20 to 35). Change from Baseline in IPSS total score was calculated as the Month 24 value minus the Baseline value. LOCF analysis involves bringing forward the last non-missing post-Baseline assessment for a participant with missing data and/or for a participant who discontinued from the study."|Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24|Intent-to-Treat (ITT) Population: all randomized participants regardless of whether or not treatment was administered. Any participant who received a treatment randomization number was considered to have been randomized. Participants with data available at the specified time point or using LOCF (post-Baseline) were summarized.||Scores on a scale||Standard Error|Least Squares Mean
836387|NCT01294644|Secondary|Change From Baseline in Body Image Quality of Life Inventory (BIQLI)||Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)||01/2016||||
836388|NCT01294644|Secondary|Change From Baseline in Derriford Appearance Scale 24 (DAS24)||Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)||01/2016||||
836389|NCT01294644|Secondary|Change From Baseline in Self-rating of Attractiveness|"Self-rating of attractiveness assesses aspects of appearance from the participant's perspective by a series of 6 questions:
How attractive do you think your overall appearance (chin/neck, eyes, nose, mouth, entire face) is/are? Each question was answered on a scale from 1 to 9 where 1 = Not at all attractive, 5 = Neither attractive nor unattractive and 9 = Extremely attractive.
A positive change from Baseline indicates improvement."|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)|Intent-to-treat population with available data||units on a scale||Standard Deviation|Mean
836390|NCT01294644|Secondary|Change From Baseline in Patient-Reported Submental Fat Impact Scale (PR-SMFIS)|The PR-SMFIS assesses the impact of submental fat on self-perception of 6 characteristics related to the appearance of submental fullness as evaluated by the participant. Each item is rated on an 11-point numeric scale from 0 to 10.|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)||01/2016||||
836391|NCT01294644|Secondary|Change From Baseline in Patient-reported Submental Fat Rating Scale (PR-SMFRS)|"The PR-SMFRS is based on the participant's response to the question How much fat do you currently have under your chin? answered on a 5-point ordinal scale (0-4) with 0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat. Improvement is defined as any decrease in score and worsened as any increase in score."|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)|Intent-to-treat population with available data||percentage of participants|||Number
836392|NCT01294644|Secondary|Change From Baseline in Submental Fat Thickness|Submental thickness was measured using caliper devices.|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)|Intent-to-treat population with available data||mm||Standard Deviation|Mean
836393|NCT01294644|Secondary|Change From Baseline in SSRS Scores|"The SSRS assesses participant's satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6: where 0 = Extremely dissatisfied, 1 = Dissatisfied, 2 = Slightly dissatisfied, 3 = Neither satisfied nor dissatisfied, 4 = Slightly satisfied, 5 = Satisfied and 6 = Extremely satisfied.
A positive change from Baseline indicates improvement."|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)|Intent-to-treat population with available data||units on a scale||Standard Deviation|Mean
836431|NCT01294748|Secondary|Device Success|Achievement of a final in-stent residual diameter stenosis of <50% (by QCA), using the assigned device only.|8 hours|||percentage of participants|||Number
836395|NCT01294644|Primary|Percentage of Participants With a Subject Self Rating Scale (SSRS) Response|"A SSRS response is defined as an SSRS score that is 4 or greater 12 weeks after the last treatment.
The SSRS assesses participant's satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6: where 0 = Extremely dissatisfied, 1 = Dissatisfied, 2 = Slightly dissatisfied, 3 = Neither satisfied nor dissatisfied, 4 = Slightly satisfied, 5 = Satisfied and 6 = Extremely satisfied."|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)|Intent-to-treat population; LOCF method was used to impute missing data||percentage of participants|||Number
836396|NCT01294644|Secondary|Percentage of Participants With a CR-SMFRS 2-grade Response|"A CR-SMFRS 2-grade response is defined as at least a 2-point improvement (i.e. 2-point reduction) from Baseline 12 weeks after the last treatment.
The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme."|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)|Intent-to-treat population; LOCF method was used to impute missing data||percentage of participants|||Number
836397|NCT01294644|Primary|Percentage of Participants With a Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) 1-grade Response|"A CR-SMFRS response is defined as at least a 1-point improvement (i.e. 1-point reduction) from Baseline 12 weeks after the last treatment.
The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme."|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)|Intent-to-treat (ITT) population which included all randomized participants who had at least one efficacy assessment (CR-SMFRS or Subject Self Rating Scale) at Baseline. Last observation carried forward (LOCF) method was used to impute missing data.||percentage of participants|||Number
836398|NCT01294683|Secondary|Percentage of Participants Who Were Discontinued From the Study Due to an AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. Participants who were discontinued from the study due to an AE were recorded.|up 22 weeks (12 weeks in Periods I/II and 10 weeks in Period III)|All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study followed a parallel design. A separate safety analysis was performed for Period III (post-crossover).||Percentage of Participants|||Number
836399|NCT01294683|Secondary|Percentage of Participants Who Experienced at Least 1 AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE.|up 22 weeks (12 weeks in Periods I/II and 10 weeks in Period III)|All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study followed a parallel design. A separate safety analysis was performed for Period III (post-crossover).||Percentage of Participants|||Number
836400|NCT01294683|Secondary|Percentage of Participants With a Confirmed Adjudicated Cardiovascular Event|Select serious adverse cardiovascular events and all-cause mortality that occurred during the treatment phase of the study were adjudicated by an expert committee external to the sponsor. Those events confirmed by the committee a cardiovascular events were recorded.|up 20 weeks (12 weeks in Periods I/II and 8 weeks in Period III)|All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study followed a parallel design. A separate safety analysis was performed for Period III (post-crossover).||Percentage of Participants|||Number
836401|NCT01294683|Secondary|Percentage of Participants With New Onset of Diabetes|Participants who with newly diagnosed of diabetes were recorded. A participant was classified as having new onset diabetes if they experienced an AE related to a diagnosis of diabetes (based on a pre-defined set of Medical Dictionary for Regulatory Activities [MedDRA] terms), or if they started taking an anti-diabetic medication during the course of the study. The MedDRA terms were as follows: diabetes mellitus, diabetes mellitus insulin-dependent, diabetes mellitus non-insulin dependent, insulin-requiring type II diabetes mellitus, insulin resistant diabetes, diabetes with hyperosmolarity, latent autoimmune diabetes in adults.|up 20 weeks (12 weeks in Periods I/II and 8 weeks in Period III)|All participants without diabetes at baseline and who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study followed a parallel design. A separate safety analysis was performed for Period III (post-crossover).||Percentage of Participants|||Number
836402|NCT01294683|Secondary|Percentage of Participants Who Experienced at Least 1 Hepatitis-related Adverse Event (AE)|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. Hepatitis-related AEs were identified by a collective review using the following pre-specified set of preferred terms: cholestasis, hepatic necrosis, hepatocellular damage, cytolytic hepatitis, hepatitis, hepatomegaly, jaundice, hepatic failure, hepatitis cholestatic, jaundice cholestatic, hepatitis fulminant, hyperbilirubinaemia, jaundice hepatocellular, ocular icterus, yellow skin, hepatic function abnormal, acute hepatic failure, subacute hepatic failure, hepatitis acute, hepatitis toxic, hepatotoxicity, and mixed hepatocellular-cholestatic injury.|up 20 weeks (12 weeks in Periods I/II and 8 weeks in Period III)|All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study followed a parallel design. A separate safety analysis was performed for Period III (post-crossover).||Percentage of Participants|||Number
836432|NCT01294748|Primary|Major Adverse Cardiac Events (MACE)|Defined as death, MI (Qwave and non-Q-wave) and TVR at 9 months post-procedure. Assessed on all patients with adequate follow-up at 270 days.|9 months|||percentage of participants|||Number
836403|NCT01294683|Secondary|Percentage of Participants With CK >=10 x ULN With Muscle Symptoms - Drug Related|Participants had CK levels assessed throughout the treatment periods. Participants who had any CK level that was >=10 x ULN and had associated muscle symptoms present within +/- 7 days that were reported as at least possibly related to study drug were recorded. The UNLs for males and females were 207 U/L and 169 U/L, respectively.|up 20 weeks (12 weeks in Periods I/II and 8 weeks in Period III)|All randomized participants who received at least 1 dose of study drug and had at least 1 postbaseline measurement within 14 days of the last dose of study drug. Analysis was based on the experiences accumulated during Periods I/II combined, where the study followed a parallel design. A separate safety analysis was performed for Period III.||Percentage of Participants|||Number
836404|NCT01294683|Secondary|Percentage of Participants With Creatine Kinase (CK) >=10 x ULN|Participants had CK levels assessed throughout the treatment periods. Participants who had any CK level that was >=10 x ULN were recorded. The UNLs for males and females were 207 U/L and 169 U/L, respectively.|up 20 weeks (12 weeks in Periods I/II and 8 weeks in Period III)|All randomized participants who received at least 1 dose of study drug and had at least 1 postbaseline measurement within 14 days of the last dose of study drug. Analysis was based on the experiences accumulated during Periods I/II combined, where the study followed a parallel design. A separate safety analysis was performed for Period III.||Percentage of Participants|||Number
836405|NCT01294683|Secondary|Percentage of Participants With Elevations in ALT and/or AST of >=10 x ULN|Participants had AST and ALT levels assessed during Period I (4 weeks ) throughout each 8 week treatment period (20 weeks total). Participants who had an assessment of either AST or ALT that was 10 x ULN or greater were recorded. The AST UNLs for males and females were 43 U/L and 36 U/L, respectively. The ALT UNLs for males and females were 40 U/L and 33 U/L, respectively.|up 20 weeks (12 weeks in Periods I/II and 8 weeks in Period III)|All randomized participants who received at least 1 dose of study drug and had at least 1 postbaseline measurement within 14 days of the last dose of study drug. Analysis was based on the experiences accumulated during Periods I/II combined, where the study followed a parallel design. A separate safety analysis was performed for Period III.||Percentage of Participants|||Number
836406|NCT01294683|Secondary|Percentage of Participants With Elevations in ALT and/or AST of >=5 x ULN|Participants had AST and ALT levels assessed during Period I (4 weeks ) throughout each 8 week treatment period (20 weeks total). Participants who had an assessment of either AST or ALT that was 5 x ULN or greater were recorded. The AST UNLs for males and females were 43 U/L and 36 U/L, respectively. The ALT UNLs for males and females were 40 U/L and 33 U/L, respectively.|up 20 weeks (12 weeks in Periods I/II and 8 weeks in Period III)|All randomized participants who received at least 1 dose of study drug and had at least 1 postbaseline measurement within 14 days of the last dose of study drug. Analysis was based on the experiences accumulated during Periods I/II combined, where the study followed a parallel design. A separate safety analysis was performed for Period III.||Percentage of Participants|||Number
836407|NCT01294683|Secondary|Percentage of Participants With Consecutive Elevations in Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) of >=3 x Upper Limit of Normal (ULN)|Participants had AST and ALT levels assessed during Period I (4 weeks ) and throughout each 8 week treatment period (20 weeks total). Participants who had an assessment of either AST or ALT that was 3 x ULN or greater were recorded. The AST UNLs for males and females were 43 U/L and 36 U/L, respectively. The ALT UNLs for males and females were 40 U/L and 33 U/L, respectively.|Up 20 weeks (12 weeks in Periods I/II and 8 weeks in Period III)|All randomized participants who received at least 1 dose of study drug and had at least 1 postbaseline measurement within 14 days of the last dose of study drug. Analysis was based on the experiences accumulated during Periods I/II combined, where the study followed a parallel design. A separate safety analysis was performed for Period III.||Percentage of Participants|||Number
836408|NCT01294683|Secondary|Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)|"Blood samples were taken at baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment (Week 12 for Period II and Week 20 for Period III) to determine the HDL-C levels. The change from baseline after 8 weeks of treatment was recorded.
Results from recent studies indicated that the combination tablet formulations used in the study did not meet the pre-specified pharmacokinetic bounds used to establish the equivalence of the combination tablet (MK-0524B; ERN/LRPT/SIM) to the coadministration of MK-0524A (ERN/LRPT) and SIM. Therefore, efficacy data were not analyzed, as the study was stopped early. Only safety data were evaluated."|Baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment during each period (Week 12 for Period II and Week 20 for Period III)|Study was terminated by the Sponsor prior to completion. No planned efficacy summaries or analyses were completed.|||||
836409|NCT01294683|Primary|Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)|"Blood samples were taken at baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment (Week 12 for Period II and Week 20 for Period III) to determine the LDL-C levels. The change from baseline after 8 weeks of treatment was recorded.
Results from recent studies indicated that the combination tablet formulations used in the study did not meet the pre-specified pharmacokinetic bounds used to establish the equivalence of the combination tablet (MK-0524B; ERN/LRPT/SIM) to the coadministration of MK-0524A (ERN/LRPT) and SIM. Therefore, efficacy data were not analyzed, as the study was stopped early. Only safety data were evaluated."|Baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment (Week 12 for Period II and Week 20 for Period III)|Study was terminated by the Sponsor prior to completion. No planned efficacy summaries or analyses were completed.|||||
836410|NCT01294696|Secondary|Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 12|Joint stiffness or limitation in physical function was evaluated using the Western Ontario and McMasters Universities (WOMAC) visual analog (VA)3.0 Index. The WOMAC VA 3.0 is a self-administered, tri-dimensional, disease-specific health status measure. It probes clinically important, subject-relevant symptoms in the areas of pain, joint stiffness and physical function in subjects with osteoarthritis of the knee. The index consists of 24 questions (5 pain, 2 stiffness and 17 physical function) and uses a VA scale of 0-500 mm for pain, 0-200 mm for stiffness, and 0-1700 for physical limitation with higher scores indicating poorer outcomes. Adequate pain was defined as participants reporting less than 4 on the BPI average pain scale.|Month 12|The population consisted of all participants for which WOMAC VA 3.0 data was available at Month 12.||Percentage of Participants|||Number
836411|NCT01294696|Secondary|Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 9|Joint stiffness or limitation in physical function was evaluated using the Western Ontario and McMasters Universities (WOMAC) visual analog (VA)3.0 Index. The WOMAC VA 3.0 is a self-administered, tri-dimensional, disease-specific health status measure. It probes clinically important, subject-relevant symptoms in the areas of pain, joint stiffness and physical function in subjects with osteoarthritis of the knee. The index consists of 24 questions (5 pain, 2 stiffness and 17 physical function) and uses a VA scale of 0-500 mm for pain, 0-200 mm for stiffness, and 0-1700 for physical limitation with higher scores indicating poorer outcomes. Adequate pain was defined as participants reporting less than 4 on the BPI average pain scale.|Month 9|The population consistated of all participants for which WOMAC VA 3.0 data were available at Month 9.||Percentage of Participants|||Number
836412|NCT01294696|Secondary|Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 6|Joint stiffness or limitation in physical function was evaluated using the Western Ontario and McMasters Universities (WOMAC) visual analog (VA)3.0 Index. The WOMAC VA 3.0 is a self-administered, tri-dimensional, disease-specific health status measure. It probes clinically important, subject-relevant symptoms in the areas of pain, joint stiffness and physical function in subjects with osteoarthritis of the knee. The index consists of 24 questions (5 pain, 2 stiffness and 17 physical function) and uses a VA scale of 0-500 mm for pain, 0-200 mm for stiffness, and 0-1700 for physical limitation with higher scores indicating poorer outcomes. Adequate pain was defined as participants reporting less than 4 on the BPI average pain scale.|Month 6|The population consisted of all participants for which WOMAC VA 3.0 data were available at Month 6.||Percentage of Participants|||Number
836413|NCT01294696|Secondary|Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 3|Joint stiffness or limitation in physical function was evaluated using the Western Ontario and McMasters Universities (WOMAC) visual analog (VA)3.0 Index. The WOMAC VA 3.0 is a self-administered, tri-dimensional, disease-specific health status measure. It probes clinically important, subject-relevant symptoms in the areas of pain, joint stiffness and physical function in subjects with osteoarthritis of the knee. The index consists of 24 questions (5 pain, 2 stiffness and 17 physical function) and uses a VA scale of 0-500 mm for pain, 0-200 mm for stiffness, and 0-1700 for physical limitation with higher scores indicating poorer outcomes. Adequate pain was defined as participants reporting less than 4 on the BPI average pain scale.|Month 3|The population consisted of all participants for which WOMAC VA 3.0 data were available at Month 3.||Percentage of Participants|||Number
836414|NCT01294696|Secondary|Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 1|Joint stiffness or limitation in physical function was evaluated using the Western Ontario McMaster Osteoarthritis (WOMAC) visual analog (VA)3.0 Index. The WOMAC VA 3.0 is a self-administered, tri-dimensional, disease-specific health status measure. It probes clinically important, subject-relevant symptoms in the areas of pain, joint stiffness and physical function in subjects with osteoarthritis of the knee. The index consists of 24 questions (5 pain, 2 stiffness and 17 physical function) and uses a VA scale of 0-500 mm for pain, 0-200 mm for stiffness, and 0-1700 for physical limitation with higher scores indicating poorer outcomes. Adequate pain was defined as participants reporting less than 4 on the BPI average pain scale.|Month 1|The population consisted of all participants for which a WOMAC VA 3.0 measurement was available at Month 1.||Percentage of Participants|||Number
836415|NCT01294696|Secondary|Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Baseline (Day 1)|Joint stiffness or limitation in physical function was evaluated using the Western Ontario and McMasters Universities (WOMAC) visual analog (VA)3.0 Index. The WOMAC VA 3.0 is a self-administered, tri-dimensional, disease-specific health status measure. It probes clinically important, subject-relevant symptoms in the areas of pain, joint stiffness and physical function in subjects with osteoarthritis of the knee. The index consists of 24 questions (5 pain, 2 stiffness and 17 physical function) and uses a VA scale of 0-500 mm for pain, 0-200 mm for stiffness, and 0-1700 for physical limitation with higher scores indicating poorer outcomes. Adequate pain was defined as participants reporting less than 4 on the BPI average pain scale.|Baseline (Day 1)|The population consisted of all participants for which WOMAC VA 3.0 data for joint stiffness and limiation in physical function were available at Baseline.||Percentage of Participants|||Number
836416|NCT01294696|Primary|Percentage of Participants Who Reported Adequate vs. Inadequate Pain Relief at Month 12|Participant pain at baseline was recorded using the Brief Pain Inventory (BPI). The BPI is an inventory of subject-reported questions, where for each pain severity item the response scale is 0 = No Pain and 10 = Worst Pain You Can Imagine. The questions refer to pain in the last week: at its worst, at its least, on the average, and right now. Adequate pain control was defined as a score of <=4 on question 5 of the BPI. Inadequate pain control was defined as a score >4 on question 5 of the BPI. Question 5 of the BPI asked participants to rate their pain by circling the number that best describes their pain on the average scale from 0 to 10 (with 0=no pain and 10=worst pain imaginable).|Month 12|The population consisted of all participants for which a BPI value was avaialble at Month 12.||Percentage of Participants|||Number
836417|NCT01294696|Primary|Percentage of Participants Who Reported Adequate vs. Inadequate Pain Relief at Baseline|Participant pain at baseline was recorded using the Brief Pain Inventory (BPI). The BPI is an inventory of subject-reported questions, where for each pain severity item the response scale is 0 = No Pain and 10 = Worst Pain You Can Imagine. The questions refer to pain due to osteoarthritis in the affected knee in the last week: at its worst, at its least, on the average, and right now. Adequate pain control was defined as a score of <=4 on question 5 of the BPI. Inadequate pain control was defined as a score >4 on question 5 of the BPI. Question 5 of the BPI asked participants to rate their pain by circling the number that best describes their pain on the average scale from 0 to 10 (with 0=no pain and 10=worst pain imaginable).|Baseline (Day 1)|The population consisted of all participants for which a BPI value was available at baseline.||Percentage of Participants|||Number
836433|NCT01294748|Primary|In-Stent Late Lumen Loss|Measured by the angiographic core laboratory as the difference between the post-procedure MLD in the treated segment (stented region) minus the MLD in the same region at follow-up|9 months|||mm||Standard Deviation|Mean
836684|NCT01296412|Secondary|Percentage of Participants Reaching A1C Goal of <7.0%||Week 26|Per-protocol population defined as participants who had a measurement at baseline and a measurement after at least 24 weeks (i.e., 168 days) of treatment, and did not have any major protocol violations.||percentage of participants|||Number
836418|NCT01294709|Secondary|Time to 1 mm ST Segment Depression|Bruce (and Modified Bruce) Protocol was used to assess the exercise duration on a treadmill. This protocol consists of a standardized gradual incremental increase in external workload every 3 minutes while the participant’s ECG, symptoms, and arm blood pressure were continuously monitored. The ECG was reviewed and the time to the first ST segment depression of 1 mm was recorded.|2.5 to approximately 2.75 hours post dose of each treatment period|Enrolled participants with evaluable data for assessment of time to 1 mm ST segment depression available. Data from the 600 and 900 mg telcagepant treatments were grouped for comparsion to placebo.||seconds||95% Confidence Interval|Least Squares Mean
836419|NCT01294709|Secondary|ST Segment Depression at Peak Exercise|Bruce (and Modified Bruce) Protocol was used to assess the exercise duration on a treadmill. This protocol consists of a standardized gradual incremental increase in external workload every 3 minutes while the participant’s ECG, symptoms, and arm blood pressure were continuously monitored. The time of peak exercise was considered the time at which the participant reached at least one of the criteria for stopping the treadmill test (evidence of chest discomfort, severe shortness of breath, dizziness, fatigue, ST-segment depression of greater than 2 mm, a fall in systolic blood pressure exceeding 10 mmHg, or the development of a ventricular tachyarrhythmia). The ECG for that timepoint (time of peak exercise) was evaluated and the amount of ST segment depression was determined.|2.5 to approximately 2.75 hours post dose of each treatment period|Enrolled participants with evaluable data for assessment of ST segment depression at peak exercise available. Data from the 600 and 900 mg telcagepant treatments were grouped for comparsion to placebo.||mm||95% Confidence Interval|Least Squares Mean
836420|NCT01294709|Primary|Total Exercise Duration on the Treadmill Test|Bruce (and Modified Bruce) Protocol was used to assess the exercise duration on a treadmill. This protocol consists of a standardized gradual incremental increase in external workload every 3 minutes while the participant’s electrocardiogram (ECG), symptoms, and arm blood pressure were continuously monitored. Regardless of whether the participant believed he or she could continue, the test was discontinued upon evidence of chest discomfort, severe shortness of breath, dizziness, fatigue, ST-segment depression of greater than 2 mm, a fall in systolic blood pressure exceeding 10 mmHg, or the development of a ventricular tachyarrhythmia|2.5 to approximately 2.75 hours post dose of each treatment period|Enrolled participants with evaluable treadmill exercise duration data available. Data from the 600 and 900 mg telcagepant treatments were grouped for comparsion to placebo.||Seconds||95% Confidence Interval|Least Squares Mean
836421|NCT01294709|Primary|Number of Participants With Laboratory Adverse Events|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test.|Up to 10 days post dose in Period 1 and up to 14 days post dose in Period 2|Safety Population which consisted of all enrolled participants who actually received assigned study drug in a particular period . Adverse events are reported by dose taken in a given treatment period and not by randomly assigned treatment sequence.||Participants|||Number
836422|NCT01294709|Primary|Number of Participants With Clinical Adverse Events (AEs)|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. A clinical AE was an AE reported as a result of a clinical examination or reported by the participant.|Up to 10 days post dose in Period 1 and up to 14 days post dose in Period 2|Safety Population which consisted of all enrolled participants who actually received assigned study drug in a particular period . Adverse events are reported by dose taken in a given treatment period and not by randomly assigned treatment sequence.||Participants|||Number
836423|NCT01294748|Secondary|Stent Thrombosis (Definite/Probable)|The presence of an intracoronary thrombus that originates in the stent or in the segments 5 mm proximal or distal to the stent post-procedure|9-months|||percentage of patients|||Number
836424|NCT01294748|Secondary|Target Lesion Failure (TLF)|Composite endpoint of cardiac death, target-lesion myocardial infarction (Q wave or non-Q wave), and clinically indicated target lesion revascularization|9-months|||percentage of patients|||Number
836425|NCT01294748|Secondary|Target Vessel Failure (TVF)|Composite endpoint of cardiac death, target-vessel myocardial infarction (Q wave or non-Q wave), and clinically indicated target vessel revascularization|9-months|||percentage of patients|||Number
836426|NCT01294748|Secondary|Clinically-driven Target Lesion Revascularization (TVR)|TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel (main branch or side branch). The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion, which includes upstream and downstream branches, and the target lesion itself.|9-months|||percentage of patients|||Number
836427|NCT01294748|Secondary|Total Myocardial Infarct (MI)|"Q-wave MI (QWMI): requires one of the following criteria: development of new abnormal Q waves in ≥2 contiguous ECG leads not present on the patient's baseline (i.e., before intervention) in association with a >2x ULN elevation of CK levels; chest pain or other acute symptoms consistent with myocardial ischemia and new pathological Q waves in ≥2 contiguous ECG leads in the absence of timely cardiac enzyme data.
Non-Q-wave MI (NQWMI):the elevation of CK levels (≥2 times ULN) with elevated CK-MB enzyme levels (≥3 times ULN) in the absence of new pathologic Q waves.
Peri-Procedural MI post PCI:Q or non-Q-wave MI, as defined above, prior to hospital discharge, or CK-MB elevation >3xULN within 48 hours post –PCI, with a normal CK-MB at baseline."|9-months|||percentage of patients|||Number
836428|NCT01294748|Secondary|Total Mortality||9-months|||percentage of patients|||Number
836429|NCT01294748|Secondary|Procedural Success|Achievement of a final in-stent residual diameter stenosis of <50% (by QCA) using the assigned device (including any adjunctive devices) without cardiac death, MI or repeat revascularization of the target lesion pre-hospital discharge.|8 hours|||percentage of participants|||Number
836430|NCT01294748|Secondary|Lesion Success|Achievement of a final in-stent residual diameter stenosis of <50% (by QCA) using any percutaneous method.|8 hours|||percentage of participants|||Number
836478|NCT01295320|Secondary|Number of Subjects With Any Suspected Cases of HZ Episodes||Month 48 to Month 72|||Participants|||Count of Participants
836434|NCT01294787|Secondary|Exercise Endurance Time Comparison After a Single Dose of QVA149 Versus Placebo|The effect of a single dose of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured with respect to exercise endurance time during sub-maximal constant load cycle ergometry test ((SMETT)cycle exercise test).|Day 1|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.||Seconds||Standard Error|Least Squares Mean
836435|NCT01294787|Secondary|Exercise Endurance Comparison Between QVA149 and Tiotropium Groups|Effect of QVA149 110/50 µg o.d. compared with tiotropium 18 µg o.d. in patients with moderate to severe COPD with respect to exercise endurance was measured by a sub-maximal constant load cycle ergometry test ((SMETT)cycle exercise test) after three weeks of treatment.|3 weeks|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.||Seconds||Standard Error|Least Squares Mean
836436|NCT01294787|Secondary|Leg Discomfort During Exercise Comparison Between QVA149 and Placebo Groups|The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo on leg discomfort was measured using Borg CR10 Scale® during sub-maximal constant load cycle ergometry test after three weeks treatment.|3 weeks|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.||units on a scale||Standard Error|Least Squares Mean
836437|NCT01294787|Secondary|Exertional Dyspnea Comparison Between QVA149 and Placebo Groups|"The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using exertional dyspnea Borg CR10 Scale® (After 3 weeks of treatment, before, during and after exercise, patients were asked to rate the intensity of their breathing and leg discomfort using the Borg CR10 Scale®). This scale consists of 12-point score that the participants pointed to so as to indicate their level of dyspnea before and during exercise testing (where 0 indicates no breathlessness at all and 12 indicates maximum breathlessness).
A reduction in this score indicates an improvement."|3 weeks|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.||units on a scale||Standard Error|Least Squares Mean
836438|NCT01294787|Secondary|Spirometry After Three Weeks of Treatment on Patients Not Exercising|The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using dynamic inspiratory capacity post-dose pre-exercise after three weeks of treatment.|3 weeks|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.||Liters||Standard Error|Least Squares Mean
836439|NCT01294787|Secondary|Pulmonary Function Test (FRC) Comparison Between QVA149 and Placebo Groups|The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using the pulmonary function test for Functional Residual Capacity (FRC) on day 1 and day 21, at 5 min and 15 min post dose as determined by body plethysmography.|day 1 and day 21|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.||Liters||Standard Error|Least Squares Mean
836440|NCT01294787|Secondary|Pulmonary Function Test (SGaw) Comparison Between QVA149 and Placebo Groups|The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using the pulmonary function test for Specific Airway Conductance (SGaw) on day 1 and day 21, at 5 min and 15 min post dose as determined by body plethysmography.|day 1 and day 21|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.||Kilo Pascal per second||Standard Error|Least Squares Mean
836441|NCT01294787|Secondary|Pulmonary Function Test (RV) Comparison Between QVA149 and Placebo Groups|The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using the pulmonary function test for Residual Volume (RV) on day 1 and day 21, at 5 min and 15 min post dose as determined by body plethysmography.|day 1 and day 21|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.||Liters||Standard Error|Least Squares Mean
836442|NCT01294787|Secondary|Pulmonary Function Test Comparison Between QVA149 and Placebo Groups|The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using the pulmonary function test for Slow Vital Capacity (SVC) on day 1 and day 21, at 5 min and 15 min post dose as determined by body plethysmography.|day 1 and day 21|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.||Liters||Standard Error|Least Squares Mean
836443|NCT01294787|Secondary|Trough 24 Hour Post Dose Forced Expiratory Volume in One Second Comparison Between QVA149 and Placebo Groups|The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using trough 24 hour post dose Forced Expiratory Volume in one second (FEV1) after three weeks of treatment.|3 weeks|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.||Liters||Standard Error|Least Squares Mean
836444|NCT01294787|Secondary|Trough 24 Hour Post Dose Inspiratory Capacity Comparison Between QVA149 and Placebo Groups|The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using trough 24 hour post dose inspiratory capacity after three weeks of treatment.|3 weeks|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.||Liters||Standard Error|Least Squares Mean
836445|NCT01294787|Secondary|Dynamic Inspiratory Capacity Comparison Between QVA149 and Placebo Groups|The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using dynamic inspiratory capacity at isotime during sub-maximal constant load cycle ergometry test ((SMETT)a cycle exercise test), after three weeks of treatment.|3 weeks|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.||Liters||Standard Error|Least Squares Mean
836446|NCT01294787|Primary|Exercise Tolerance Comparison Between QVA149 and Placebo Groups|The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured by exercise endurance time (in seconds) during a sub-maximal constant load cycle ergometry test ((SMETT)which is a cycle exercise test) after three weeks of treatment.|3 weeks|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.||Seconds||Standard Error|Least Squares Mean
836447|NCT01294800|Primary|Number of Participants Who Discontinued Study Treatment Due to an AE|An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.|Up to 12 Weeks|All Participants as Treated population, which included all participants who received at least one dose of study drug||Participants|||Number
836448|NCT01294800|Primary|Number of Participants Who Experienced an Adverse Event (AE)|An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.|Up to 14 weeks|All Participants as Treated population, which included all participants who received at least one dose of study drug||Participants|||Number
836449|NCT01294800|Secondary|Change From Baseline in Mean “On” Time Without Troublesome Dyskinesias (Hours Per Day) at Week 12|"When a participant is on without dyskinesias, parkinsonian symptoms have dissipated and the participant is experiencing no uncontrollable extraneous movements. Study participants reported their parkinsonian symptoms at half-hour intervals as off, on without dyskinesia, on with non-troublesome dyskinesia, on with troublesome dyskinesia, or asleep on their daily diary for 3 days before randomization and for the 3 days immediately before their Week-12 visit. The mean change from baseline in on without troublesome dyskinesia time was based on a constrained longitudinal data analysis with treatment, time, and treatment-by-time interaction as fixed effects, and an unstructured covariance matrix was used to model the correlation among repeated measurements."|Baseline and Week 12|FAS population, which consisted of all randomized participants who received at least one dose of study treatment; had endpoint data subsequent to at least one dose of study treatment; and had baseline data for those analyses requiring baseline data.||Hours/Day||Standard Deviation|Mean
836450|NCT01294800|Secondary|Percentage of Participants With ≥30% Reduction in “Off” Time at Week 12|The proportion of responders (≥30% Reduction in “Off” Time at Week 12) was analyzed using a generalized linear mixed model with baseline mean OFF time (hours/day) as a covariate and treatment-by-time interaction as a fixed effect, and an unstructured covariance matrix was used to model the correlation among repeated measurements. Responder rates for each treatment arm are presented as are differences from placebo with 95% confidence interval.|Up to 12 Weeks|Full Analysis Set (FAS) population, which consisted of all randomized participants who received at least one dose of study treatment; had endpoint data subsequent to at least one dose of study treatment; and had baseline data for those analyses requiring baseline data.||Percentage of participants|||Number
836451|NCT01294800|Primary|Change From Baseline in Mean “Off” Time (Hours Per Day) at Week 12|"The on state is defined as the period of time during which a participant's symptoms of PD improve or disappear following treatment with levodopa (L-dopa) or dopamine agonists. The off state is defined as the period of time characterized by the return of symptoms (i..e. tremor, slowness, and rigidity) following treatment with L-dopa or dopamine agonists. Study participants reported their symptoms at half-hour intervals as off, on, or asleep on their daily diary for 3 days before randomization (baseline) and for the 3 days immediately before their Week-12 visit. The mean change from baseline in off time was based on a constrained longitudinal data analysis with treatment, time, and treatment-by-time interaction as fixed effects, and an unstructured covariance matrix was used to model the correlation among repeated measurements."|Baseline and Week 12|Full Analysis Set (FAS) population, which consisted of all randomized participants who received at least one dose of study treatment; had endpoint data subsequent to at least one dose of study treatment; and had baseline data for those analyses requiring baseline data.||Hours/Day||Standard Deviation|Mean
836452|NCT01294917|Secondary|Dryness|This will be assessed by the tear break-up time on the lens surface, measured in seconds.|4 weeks||||||
836453|NCT01294917|Secondary|Subjective Lens Wearing Comfort|This will be assessed by a questionnaire on patient-perceived lens comfort and any symptoms of discomfort on a 0 to 100 scale.|4 weeks||||||
836454|NCT01294917|Primary|Corneal Staining|Corneal staining will be assessed with sodium fluorescein dye on the ocular surface. The cornea is split into 5 sections, each section is evaluated by staining type, depth, and extent is graded on a 0 to 100 scale with higher scores indicating more staining. The possible total range for the total score per eye is 0 to 50,000 (100x100x100=10,000 per section) with values higher than 1200 being clinically relevant.|4 weeks|Only subjects that completed all three arms were included in analysis.||units on a scale||Standard Deviation|Mean
836455|NCT01295034|Secondary|CD4+T Cell Count|The change in the CD4+T cell count between the two arms.|baseline and 12 months|Analysis only for participants who completed the study.||cell/μL||Inter-Quartile Range|Median
836456|NCT01295034|Primary|25(OH)D Levels|The difference in the percentage of subjects with 25(OH)D levels in the range of 30-60 ng/ml at 12 mo between the two arms.|baseline and 12 months|||Participants|||Count of Participants
836457|NCT01295216|Secondary|Change From Baseline in Physical Activity at 12 Months||Baseline and 12 months|||MET/min/week||95% Confidence Interval|Mean
836458|NCT01295216|Secondary|Change From Baseline in Waist Circumference at 12 Months||Baseline and 12 months|||cm||95% Confidence Interval|Mean
836459|NCT01295216|Secondary|Change From Baseline in Body Mass Index at 12 Months||Baseline and 12 months|||kg/m2||95% Confidence Interval|Mean
836460|NCT01295216|Secondary|Change From Baseline in Body Weight at 12 Months||Baseline and 12 months|||kg||95% Confidence Interval|Mean
836461|NCT01295216|Secondary|Change From Baseline in Food Intake at 12 Months||Baseline and 12 months|||Servings/day||95% Confidence Interval|Mean
836462|NCT01295216|Primary|Change From Baseline in Systolic and Diastolic Blood Pressure at 6, 12, and 18 Months|A reduction in systolic and diastolic blood pressure is expected as early as 6 months of intervention and it is expected that this reduction is maintained or even continue to decrease over time|Baseline, 6, 12, and 18 months|||mmHg||95% Confidence Interval|Mean
836479|NCT01295320|Secondary|Number of Subjects With Any Fatal SAEs|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Month 48 to Month 72|||Participants|||Count of Participants
836463|NCT01295281|Secondary|Perception of Discomfort Due to Other Causes|To compare subject’s tolerability with regards to perceived discomfort due to other causes, when using two different urinary catheters 2.0. Frequency of discomfort due to other causes (yes/ no) will be assessed in patient questionnaire. The frequency of discomfort due to other causes will be compared between the treatments. Discomfort due to other causes will be further specified using 5-graded scale (as for the other variables on the 5-graded scale the difference between the treatments will be calculated for each subject).|At 7 and 14 days after randomization, respectively||||||
836464|NCT01295281|Secondary|Perception of Resistance|To evaluate subject perception related to the properties of the catheter’s coating/surface, when practising intermittent self catheterization with urinary catheters; PVC vs. POBE 2.0. Assessed in patient questionnaire for each subject. A 5-graded scale will be used to determine the perception and the severity of each variable. The difference between the treatments will be calculated for each subject.|At 7 and 14 days after randomization, respectively||||||
836465|NCT01295281|Secondary|Perception of Smoothness|To evaluate subject perception related to the properties of the catheter’s coating/surface, when practising intermittent self catheterization with urinary catheters; PVC vs. POBE 2.0. Assessed in patient questionnaire for each subject. A 5-graded scale will be used to determine the perception and the severity of each variable. The difference between the treatments will be calculated for each subject.|At 7 and 14 days after randomization, respectively||||||
836466|NCT01295281|Secondary|Perception of Slipperiness|To evaluate subject perception related to the properties of the catheter’s coating/surface, when practising intermittent self catheterization with urinary catheters; PVC vs. POBE 2.0. Assessed in patient questionnaire for each subject. A 5-graded scale will be used to determine the perception and the severity of each variable. The difference between the treatments will be calculated for each subject.|At 7 and 14 days after randomization, respectively||||||
836467|NCT01295281|Secondary|Perception of Catheter Tip|To evaluate subject perception related to the physical properties of the catheter, when practising intermittent self catheterization with urinary catheters; PVC vs. POBE 2.0. Assessed in patient questionnaire for each subject. A 5-graded scale will be used to determine the perception and the severity of each variable. The difference between the treatments will be calculated for each subject.|At 7 and 14 days after randomization, respectively||||||
836468|NCT01295281|Secondary|Perception of Catheter Adherence|To evaluate subject perception related to the physical properties of the catheter, when practising intermittent self catheterization with urinary catheters; PVC vs. POBE 2.0. Assessed in patient questionnaire for each subject. A 5-graded scale will be used to determine the perception and the severity of each variable. The difference between the treatments will be calculated for each subject.|At 7 and 14 days after randomization, respectively||||||
836469|NCT01295281|Secondary|Perception of Catheter Eyes|To evaluate subject perception related to the physical properties of the catheter, when practising intermittent self catheterization with urinary catheters; PVC vs. POBE 2.0. Assessed in patient questionnaire for each subject. A 5-graded scale will be used to determine the perception and the severity of each variable. The difference between the treatments will be calculated for each subject.|At 7 and 14 days after randomization, respectively||||||
836470|NCT01295281|Secondary|Perception of Stiffness/ Rigidity|To evaluate subject perception related to the physical properties of the catheter, when practising intermittent self catheterization with urinary catheters; PVC vs. POBE 2.0. Assessed in patient questionnaire for each subject. A 5-graded scale will be used to determine the perception and the severity of each variable. The difference between the treatments will be calculated for each subject.|At 7 and 14 days after randomization, respectively||||||
836471|NCT01295281|Secondary|Perception of “Other Discomfort”|To compare subject’s tolerability with regards to perceived “other discomfort”, when using two different urinary catheters; PVC vs. POBE 2.0. Frequency of “other discomfort” (yes/ no) will be assessed in patient questionnaire. The frequency of “other discomfort” will be compared between the treatments. “Other discomfort” will be further specified using 5-graded scale (as for the other variables on the 5-graded scale the difference between the treatments will be calculated for each subject).|At 7 and 14 days after randomization, respectively||||||
836472|NCT01295281|Secondary|Presence of Bleeding|To compare subject’s tolerability with regards to presence of bleeding, when using two different urinary catheters; PVC vs. POBE 2.0. Assessed in patient questionnaire for each subject. A 5-graded scale will be used to determine the perception and the severity of each variable. The difference between the treatments will be calculated for each subject.|At 7 and 14 days after randomization, respectively||||||
836473|NCT01295281|Secondary|Perception of Burning Sensation|To compare subject’s tolerability with regards to perceived burning sensation, when using two different urinary catheters; PVC vs. POBE 2.0. Assessed in patient questionnaire for each subject. A 5-graded scale will be used to determine the perception and the severity of each variable. The difference between the treatments will be calculated for each subject.|At 7 and 14 days after randomization, respectively||||||
836474|NCT01295281|Secondary|Perception of Pain|To compare subject’s tolerability with regards to perceived pain, when using two different urinary catheters; PVC vs. POBE 2.0. Assessed in patient questionnaire for each subject. A 5-graded scale will be used to determine the perception and the severity of each variable. The difference between the treatments will be calculated for each subject.|At 7 and 14 days after randomization, respectively||||||
836475|NCT01295281|Primary|Number of Participants With Discomfort|The primary objective of this study is to compare the subject's tolerability, with regards to perceived discomfort, when using two different urinary catheters. Perception of discomfort (yes/ no) will be assessed in patient questionnaire for each subject. The frequency of discomfort will be compared between the treatments.|At 7 and 14 days after randomization, respectively|"Since the study is cross-over, all (104) subjects evaluated both LoFric POBE 2.0 and LoFric PVC. To be able to group and describe the results the Arm/Group Titles are renamed in this section to LoFric POBE 2.0 and LoFric PVC respectively. Each Arm/Group describing the outcome for all 104 subjects (ITT analysis set)."||participants|||Number
836476|NCT01295320|Secondary|Number of Subjects and Relationship to Vaccination of Any Potential Immune Mediated Diseases (pIMDs) Following Participation in 108494 Study and Its Follow-ups (108516, 108518 and 108520) and Not Already Documented||Month 48 to Month 72|||Participants|||Count of Participants
836477|NCT01295320|Secondary|Number of Subjects With Any Suspected Cases of HZ Episodes Following Participation in 108494 Study and Its Follow-ups (108516, 108518 and 108520) and Not Already Documented||Month 48 to Month 72|||Participants|||Count of Participants
836480|NCT01295320|Secondary|Number of Subjects With Any SAEs Related to Previous Vaccination and Not Already Documented|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Month 0 to Month 72|||Participants|||Count of Participants
836481|NCT01295320|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs) Related to the Study Participation|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Month 48 to Month 72|||Participants|||Count of Participants
836482|NCT01295320|Primary|Antigen-specific Antibody (Ab) Concentrations|­Anti-Glicoprotein E (Anti-gE) and anti-VZV Ab concentrations as determined by Enzyme-Linked Immunosorbent Assay (ELISA)|Month 72|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol and with no elimination criteria during the study).||mIU/ml||95% Confidence Interval|Geometric Mean
836483|NCT01295320|Primary|Antigen-specific Antibody (Ab) Concentrations|­Anti-Glicoprotein E (Anti-gE) and anti-VZV Ab concentrations as determined by Enzyme-Linked Immunosorbent Assay (ELISA)|Month 60|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol and with no elimination criteria during the study).||mIU/ml||95% Confidence Interval|Geometric Mean
836484|NCT01295320|Primary|Antigen-specific Antibody (Ab) Concentrations|­Anti-Glicoprotein E (Anti-gE) and anti-VZV Ab concentrations as determined by Enzyme-Linked Immunosorbent Assay (ELISA)|Month 48|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol and with no elimination criteria during the study).||mIU/ml||95% Confidence Interval|Geometric Mean
836485|NCT01295320|Primary|Cell-Mediated Immunity (CMI) in Terms of Frequencies of Antigen-specific CD4 T Cells|Frequencies of CD4 T cells with antigen-specific Interferon gamma (IFN-γ) and/or Interleukin-2 (IL-2) and/or Tumour Necrosis Factor alpha (TNF-α) and/or CD40 Ligand (CD40L) secretion/expression to glycoprotein E (gE) and Varicella Zoster Virus (VZV) as determined by Intracellular Cytokine Staining (ICS)|Month 72|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol and with no elimination criteria during the study).||cells/million T-cells||Standard Deviation|Mean
836486|NCT01295320|Primary|Cell-Mediated Immunity (CMI) in Terms of Frequencies of Antigen-specific CD4 T Cells|Frequencies of CD4 T cells with antigen-specific Interferon gamma (IFN-γ) and/or Interleukin-2 (IL-2) and/or Tumour Necrosis Factor alpha (TNF-α) and/or CD40 Ligand (CD40L) secretion/expression to glycoprotein E (gE) and Varicella Zoster Virus (VZV) as determined by Intracellular Cytokine Staining (ICS)|Month 60|The analysis was base don the ATP cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol and with no elimination criteria during the study).||cells/million T-cells||Standard Deviation|Mean
836487|NCT01295320|Primary|Cell-Mediated Immunity (CMI) in Terms of Frequencies of Antigen-specific CD4 T Cells|­Frequencies of CD4 T cells with antigen-specific Interferon gamma (IFN-γ) and/or Interleukin-2 (IL-2) and/or Tumour Necrosis Factor alpha (TNF-α) and/or CD40 Ligand (CD40L) secretion/expression to glycoprotein E (gE) and Varicella Zoster Virus (VZV) as determined by Intracellular Cytokine Staining (ICS)|Month 48|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol and with no elimination criteria during the study).||cells/million T-cells||Standard Deviation|Mean
836488|NCT01295814|Secondary|Global Response Assessment (GRA)|"Percent(%) of patients who reported 50% or greater overall improvement in their condition.
Score on a scale range (improvement 0%-100%)"|Measured at12 Weeks|||percentage of participants|||Number
836489|NCT01295814|Secondary|Pelvic Pain Urgency/Frequency (PUF) Score|Pelvic Pain, Urgency/Frequency Symptom Scale Total scores on a scale range: 0-35 (0, meaning no symptoms, to 35, meaning the most severe symptoms)|Baseline12 Weeks|||units on a scale||Standard Deviation|Mean
836490|NCT01295814|Secondary|Interstitial Cystitis Problem Index (ICPI)|Improvement in O'Leary Sant Interstitial Cystitis Problem Index (ICPI) Total scores on a scale: 0-16 (0, meaning no symptoms, to 16, meaning the most severe symptoms)|Baseline/12 Weeks|||units on a scale||Standard Deviation|Mean
836491|NCT01295814|Secondary|Interstitial Cystitis Symptom Index (ICSI)|Improvement in O'Leary Sant Interstitial Cystitis Symptom Index (ICSI) Total scores on a range scale: 0-20 (0, meaning no symptoms, to 20, meaning the most severe symptoms)|Baseline/ 12 weeks|||units on a scale||Standard Deviation|Mean
836492|NCT01295814|Primary|O'Leary-Santa Interstitial Cystitis Symptom Index and Problem Index (OSPI) Score|Improvement in the O'Leary Sant Symptom and Problem Index from baseline to week 12 Total scores on a scale range: 0-36 (0, meaning no symptoms to 36, meaning the most severe symptoms)|Baseline/12 Weeks|||units on a scale||Standard Deviation|Mean
836493|NCT01295840|Secondary|Number of Patients With PNS in All Vectors, That Could be Avoided With a Non-traditional Vector|To calculate the number of patients, who exhibit PNS in all traditional vector, in which PNS could be avoided using a non-traditional vector|At 6 months|||participants|||Number
836494|NCT01295840|Secondary|Number of Patients With PNS in All Vectors|To calculate the number of patients that exhibit PNS in all traditional vector|At 6 months|||participants|||Number
836495|NCT01295840|Secondary|Number of Patients With PNS in All Vectors, That Could be Avoided With a Non-traditional Vector|To calculate the number of patients, who exhibit PNS in all traditional vector, in which PNS could be avoided using a non-traditional vector|At enrollment|||participants|||Number
836496|NCT01295840|Secondary|Number of Patients With PNS in All Vectors|To calculate the number of patients that exhibit PNS in all traditional vector|At enrollment|||participants|||Number
836497|NCT01295840|Secondary|Number of Vectors With Phrenic Nerve Stimulation (PNS)|"Capture and phrenic threshold data will be recorded for each of the stimulation vectors studied.
Attempts will also be made to avoid phrenic stimulation in those patients who suffer from it, whilst maintaining good capture thresholds, by changing between the new configurations offered by the Quartet® electrode."|At 6 months|||number of vectors|Participants||Number
836498|NCT01295840|Secondary|Number of Vectors With Phrenic Nerve Stimulation (PNS)|"Capture and phrenic threshold data will be recorded for each of the stimulation vectors studied.
Attempts will also be made to avoid phrenic stimulation in those patients who suffer from it, while maintaining good capture thresholds, by changing between the new configurations offered by the Quartet® electrode."|Enrollment visit (in the seven days after implantation of the device)|||number of vectors|Participants||Number
836499|NCT01295840|Secondary|Capture Threshold|"Capture and phrenic threshold data will be recorded for each of the stimulation vectors studied.
Attempts will also be made to avoid phrenic stimulation in those patients who suffer from it, whilst maintaining good capture thresholds, by changing between the new configurations offered by the Quartet® electrode."|6 months post-implant|||volts||Standard Deviation|Mean
836500|NCT01295840|Secondary|Capture Threshold|"Capture and phrenic threshold data will be recorded for each of the stimulation vectors studied.
Attempts will also be made to avoid phrenic stimulation in those patients who suffer from it, whilst maintaining good capture thresholds, by changing between the new configurations offered by the Quartet® electrode."|Enrollment visit (in the seven days after implantation of the device)|||volts||Standard Deviation|Mean
836501|NCT01295840|Secondary|Cardiac Output (CO) With Different Configurations at Enrollment|Means of baseline non-paced CO, best CO obtained from traditional configurations and best CO obtained from all quadripolar configurations at enrollment.|Enrollment visit (in the seven days after implantation of the device)|||L/min||Standard Deviation|Mean
836502|NCT01295840|Secondary|Percent Difference Between the Best CO From Non-traditional Vectors and Best CO From Traditional Vectors|"In patients with best CO obtained from Non-traditional, to calculate the percent difference between the best CO from Non-traditional vectors and best CO from Traditional vectors, vectors.This percentage was the CO from Non-traditional vectors minus CO from Traditional vectors then divided by CO from Traditional vectors.
The Quartet® lead has 4 poles: Distal (D1), Mid 2 (M2), Mid 3 (M3) and Proximal (P4). The 3 Traditional vectors are the traditional configurations available in a standard bipolar lead: D1-M2, D1-Right Ventricular Coil (RVC) and M2-RVC. The 7 Non-traditional vectors are the additional configurations available in a Quartet® lead: D1-P4, M2-P4, M3-M2, M3-RVC, M3-P4, P4-M2 and P4-RVC."|At enrollment|||percentage of difference of CO||Standard Deviation|Mean
836503|NCT01295840|Primary|Number of Patients Whose Cardiac Output (CO) Value in Acute, as Measured Echocardiographically, Improves With the Different Stimulation Vectors Offered by the Quartet® Left Ventricular Electrode.||Enrollment visit (in the seven days after implantation of the device)|||participants|||Number
836504|NCT01295879|Secondary|Recurrence of Kidney Stones||8 weeks|||# of stone recurrences|||Number
836505|NCT01295879|Secondary|Change in 24 Hour Urine Supersaturation of Calcium Oxalate|Elevated values of calcium oxalate supersaturation in the urine are a risk factor for recurrence of calcium kidney stones|8 weeks|||(unitless)||Standard Deviation|Mean
836506|NCT01295879|Primary|Change in 24 Hour Urine Calcium|Elevated values of urine calcium are a risk factor for recurrence of calcium kidney stones|8 weeks|||mg/day||Standard Deviation|Mean
836507|NCT01295905|Secondary|Overall Handling|As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall handling was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.|3 months of wear, lenses replaced daily|Per protocol.||Units on a scale||Standard Deviation|Mean
836508|NCT01295905|Secondary|Overall Comfort|As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.|3 months of wear, lenses replaced daily|Per protocol.||Units on a scale||Standard Deviation|Mean
836509|NCT01295905|Secondary|Overall Vision|As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall vision was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.|3 months of wear, lenses replaced daily|Per protocol.||Units on a scale||Standard Deviation|Mean
836510|NCT01295905|Primary|Corrected Distance Monocular Visual Measurement in Normal Illumination Reported as Visual Acuity|Each eye tested individually while reading a chart distant to the participant in normal lighting. Visual acuity was measured using a Snellen chart, with 20/20 Snellen acuity considered normal distance-eyesight. Visual acuity is reported as the number of eyes achieving 20/20 Snellen acuity or better.|3 months of wear, lenses replaced daily|Per protocol.||eyes|Participants||Number
836511|NCT01296035|Secondary|Adverse Events, Measured by Active Version of the NCI Common Toxicity Criteria|Adverse events (AEs) will be recorded during the duration of the trial, whether or not the events are considered related to medication. All AEs considered to be related to trial therapy will be followed for resolution, including into the post-treatment period.|Every 4 weeks while on-study, up to 24 weeks|Please see results section. In short, there were 3 serious adverse events (1 thromboembolic, 1 hypomagnesemia, 1 bowel obstruction). Additional adverse events included (in decreasing order) rash, fatigue, anemia, edema, thrombocytopenia, abdominal pain, epistaxis, hypocalcemia, and calciphylaxis||participants|Participants||Number
836512|NCT01296035|Primary|Overall Response Rate, Measured by RECIST Criteria|Documentation of known measurable or evaluable disease parameters after every 2 cycles of treatment. If any patient is withdrawn for the study prior to completion of therapy a repeat evaluation will be done at that time.|Every 8 weeks while on-study|Due to the small number of participants, data were not collected as planned|||||
836513|NCT01296152|Secondary|Regulatory T Cells (Tregs) at Baseline, Week 4 and Week 12 Using Flow Cytometry in Freshly Thawed PBMCs.|This evaluates the effect of MPA on Tregs at baseline (Day 0), week 4 and week 12 using flow cytometry in freshly thawed PBMCs. A summary of CD4+ and cluster of differentiation 8 (CD8+) anchored T-cell subsets by study week, in percent that express the marker of interest, is presented here together to provide all results pertaining to this objective in a single data table.|Day 0, Weeks 4 and 12|All 24 participants included in the primary analyses were eligible for this secondary objective. 21 participants with available data were analyzed.||Percent CD4/CD8 cells expressing marker||Inter-Quartile Range|Median
836527|NCT01296152|Secondary|LPV PK Parameter Cmax.|This evaluates the effect of MPA on the secondary LPV PK parameter Cmax obtained from both sampling periods, before DMPA injection at study day 0 and four weeks after DMPA injection at study week 4.|Day 0 and Week 4|The analysis population is the 24 A5283 participants who took DMPA with LPV/r and were eligible for the primary PK outcome of LPV AUC.||ng/mL||Full Range|Median
836514|NCT01296152|Secondary|CMI to HIV and the Common Opportunistic Agent VZV Using the Lymphocyte Proliferation Assay (LPA).|This evaluates the effect of MPA on CMI to HIV and VZV. This outcome was measured at Baseline Before DMPA (Day 0) and After DMPA (Weeks 4 and 12) using the Lymphocyte Proliferation Assay (LPA). The data table shows a summary of LPA assay results by study week with stimuli HIV and VZV. Proliferation results are reported as a stimulation index (SI) which represents the ratio of the stimulated counts per minute to unstimulated control counts per minute.|Day 0, Weeks 4 and 12|All 24 participants included in the primary analyses were eligible for this secondary objective. 22 participants with available data were analyzed.||SI Ratio||Inter-Quartile Range|Median
836515|NCT01296152|Secondary|Cell Mediated Immunity (CMI) to HIV and the Common Opportunistic Agent Varicella-zoster Virus (VZV) Using the Enzyme-linked Immunospot (ELISPOT) Assay.|This evaluates the effect of MPA on CMI to HIV and VZV at baseline before DMPA (day 0) and after DMPA (weeks 4 and 12) . Cytokines are interferon-gamma (IFN-gamma) and interleukin 2 (IL-2), and Stimuli are HIV and VZV. Summary of adjusted ELISPOT assay results is in spot forming cells (SFC)/10^6 peripheral blood mononuclear cells (PBMC) by study weeks 0, 4 and 12. The outcome measures of IFN-gamma and IL-2 measured for HIV and VZV are presented here together to provide all results pertaining to the same objective in a single data table.|Day 0, Weeks 4 and 12|All 24 participants included in the primary analyses were eligible for this secondary objective. 22 participants with available data were analyzed.||SFC/10^6 PBMC||Inter-Quartile Range|Median
836516|NCT01296152|Secondary|Percentage of Participants With HIV-1 RNA Levels <400 Copies/mL.|This evaluates the short-term impact of MPA on virologic suppression in participants taking LPV/r who have received a dose of DMPA by measuring percentage of participants with HIV-1 RNA levels <400 copies/mL at day 0 (prior to DMPA injection) and at weeks 2, 4, 8 and 12 (after DMPA injection). An FDA-approved HIV-1 RNA assay with a lower limit of detection of 75 copies/mL or less was required and the same HIV-1 RNA assay was required to be performed for each participant across all study visits. The Roche COBAS AmpliPrep/TaqMan HIV-1 and Abbott RealTime HIV-1 tests were used.|Day 0, Weeks 2, 4, 8, and 12|All 24 participants included in the primary analyses were eligible for this secondary objective, however participants occasionally missed the HIV-1 RNA draw (see N for each week in table below).||Percent of Participants|||Number
836517|NCT01296152|Secondary|Percentage of Participants With Menstrual Irregularities of Grade 1 and Higher Deemed Possibly, Probably or Definitely Related to Study Treatment.|This evaluates toxicity and safety of concomitant medication of DMPA and LPV/r, focusing specifically on the adverse event (AE) menstrual irregularities with abnormal vaginal bleeding. The AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (see references in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening, Grade 5=Death. Relationship to study treatment was determined by the study's co-chairs.|From day 0 to week 12|This analysis focuses on the 24 participants eligible for the PK analyses.||Percent of Participants|||Number
836518|NCT01296152|Secondary|RTV PK Parameter T1/2.|This evaluates the effect of MPA on the PK parameter T1/2 of RTV obtained from both sampling periods, before DMPA injection at study day 0 and after DMPA injection at study week 4.|Day 0 and Week 4|The analysis population is the 24 A5283 participants eligible for the primary PK outcome of LPV AUC. For one participant at day 0, T1/2 results were not estimated.||hour||Full Range|Median
836519|NCT01296152|Secondary|RTV PK Parameter CL/F.|This evaluates the effect of MPA on the PK parameter CL/F of RTV obtained from both sampling periods, before DMPA injection at study day 0 and after DMPA injection at study week 4.|Day 0 and Week 4|The analysis population is the 24 A5283 participants eligible for the primary PK outcome of LPV AUC.||L/hour||Full Range|Median
836520|NCT01296152|Secondary|RTV PK Parameter Tmax.|This evaluates the effect of MPA on the PK parameter Tmax of RTV obtained from both sampling periods, before DMPA injection at study day 0 and after DMPA injection at study week 4.|Day 0 and Week 4|The analysis population is the 24 A5283 participants eligible for the primary PK outcome of LPV AUC.||hour||Full Range|Median
836521|NCT01296152|Secondary|RTV PK Parameter Cmax.|This evaluates the effect of MPA on the PK parameter Cmax of RTV obtained from both sampling periods, before DMPA injection at study day 0 and after DMPA injection at study week 4.|Day 0 and Week 4|The analysis population is the 24 A5283 participants eligible for the primary PK outcome of LPV AUC.||ng/mL||Full Range|Median
836522|NCT01296152|Secondary|RTV PK Parameter Cmin.|This evaluates the effect of MPA on the PK parameter Cmin of RTV obtained from both sampling periods, before DMPA injection at study day 0 and after DMPA injection at study week 4.|Day 0 and Week 4|The analysis population is the 24 A5283 participants eligible for the primary PK outcome of LPV AUC.||ng/mL||Full Range|Median
836523|NCT01296152|Secondary|Ritonavir (RTV) PK Parameter AUC0-12h.|This evaluates the effect of MPA on the PK parameter AUC0-12h of RTV obtained from both sampling periods, before DMPA injection at study day 0 and after DMPA injection at study week 4. Blood samples were drawn for RTV concentration levels at time zero (before LPV/r dosing) and at 30 minutes and 1, 2, 3, 4, 5, 6, 8 and 10 hours after LPV/r dosing at day 0 and week 4.|Day 0 and Week 4|The analysis population is the 24 A5283 participants eligible for the primary PK outcome of LPV AUC.||ng*h/mL||Full Range|Median
836524|NCT01296152|Secondary|LPV PK Parameter T1/2.|This evaluates the effect of MPA on the secondary LPV PK parameter T1/2 obtained from both sampling periods, before DMPA injection at study day 0 and four weeks after DMPA injection at study week 4.|Day 0 and Week 4|The analysis population is the 24 A5283 participants who took DMPA with LPV/r and were eligible for the primary PK outcome of LPV AUC.||hour||Full Range|Median
836525|NCT01296152|Secondary|LPV PK Parameter CL/F.|This evaluates the effect of MPA on the secondary LPV PK parameter CL/F obtained from both sampling periods, before DMPA injection at study day 0 and four weeks after DMPA injection at study week 4.|Day 0 and Week 4|The analysis population is the 24 A5283 participants who took DMPA with LPV/r and were eligible for the primary PK outcome of LPV AUC.||L/hour||Full Range|Median
836526|NCT01296152|Secondary|LPV PK Parameter Tmax.|This evaluates the effect of MPA on the secondary LPV PK parameter Tmax obtained from both sampling periods, before DMPA injection at study day 0 and four weeks after DMPA injection at study week 4.|Day 0 and Week 4|The analysis population is the 24 A5283 participants who took DMPA with LPV/r and were eligible for the primary PK outcome of LPV AUC.||hour||Full Range|Median
836706|NCT01299896|Primary|Effectiveness of CTQ vs UC|We will measure abstinence of CTQ smokers vs those in Usual Care (UC). We will biochemically-validate (defined as salivary cotinine <10ng/ml) self reported abstinence (30 day point-prevalence) at the end of 2 years.|Two (2) year period|||percentage of participants per arm|||Number
836528|NCT01296152|Secondary|LPV PK Parameter Cmin.|This evaluates the effect of MPA on the secondary LPV PK parameter Cmin obtained from both sampling periods, before DMPA injection at study day 0 and four weeks after DMPA injection at study week 4.|Day 0 and Week 4|The analysis population is the 24 A5283 participants who took DMPA with LPV/r and were eligible for the primary PK outcome of LPV AUC.||ng/mL||Full Range|Median
836529|NCT01296152|Secondary|MPA PK Parameter Half-Life (T1/2) Determined Based on MPA Levels.|This evaluates the effect of LPV/r on the secondary MPA PK parameter T1/2 based on MPA levels measured at weeks 0, 2, 4, 6, 8, 10, and 12.|0, 2, 4, 6, 8, 10, and 12 weeks|The analysis population is the 24 A5283 participants who took DMPA with LPV/r and were eligible for the primary PK outcome of MPA AUC. A minimum of three observations in the elimination phase was required to determine T1/2 and therefore results are presented for 22 participants.||week||Full Range|Median
836530|NCT01296152|Secondary|MPA PK Parameter Clearance (CL/F) Determined Based on MPA Levels.|This evaluates the effect of LPV/r on the secondary MPA PK parameter CL/F based on MPA levels measured at weeks 0, 2, 4, 6, 8, 10, and 12.|0, 2, 4, 6, 8, 10, and 12 weeks|The analysis population is the 24 A5283 participants who took DMPA with LPV/r and were eligible for the primary PK outcome of MPA AUC.||L/week||Full Range|Median
836531|NCT01296152|Secondary|MPA PK Parameter Time to Cmax (Tmax) Determined Based on MPA Levels.|This evaluates the effect of LPV/r on the secondary MPA PK parameter Tmax based on MPA levels measured at weeks 0, 2, 4, 6, 8, 10, and 12.|0, 2, 4, 6, 8, 10, and 12 weeks|The analysis population is the 24 A5283 participants who took DMPA with LPV/r and were eligible for the primary PK outcome of MPA AUC.||week||Full Range|Median
836532|NCT01296152|Secondary|MPA PK Parameter Maximum Plasma Concentration (Cmax) Determined Based on MPA Levels.|This evaluates the effect of LPV/r on the secondary MPA PK parameter Cmax based on MPA levels measured at weeks 0, 2, 4, 6, 8, 10, and 12.|0, 2, 4, 6, 8, 10, and 12 weeks|The analysis population is the 24 A5283 participants who took DMPA with LPV/r and were eligible for the primary PK outcome of MPA AUC.||ng/mL||Full Range|Median
836533|NCT01296152|Secondary|MPA PK Parameter Minimum Plasma Concentration (Cmin) Determined Based on MPA Levels.|This evaluates the effect of LPV/r on the secondary MPA PK parameter Cmin based on MPA levels measured at weeks 0, 2, 4, 6, 8, 10, and 12.|0, 2, 4, 6, 8, 10, and 12 weeks|The analysis population is the 24 A5283 participants who took DMPA with LPV/r and were eligible for the primary PK outcome of MPA AUC.||ng/mL||Full Range|Median
836534|NCT01296152|Secondary|Percentage of Participants With Progesterone Levels Less Than the Lower Limit of Quantification (LLQ).|This evaluates the suppression of ovulation due to the potential PK interaction between DMPA and LPV/r. The LLQ of progesterone is 0.5ng/mL. The threshold for suppression of ovulation is 5ng/mL.|0, 2, 4, 6, 8, 10, and 12 weeks|All 24 participants included in the primary analyses were eligible for this secondary objective, however participants occasionally missed the progesterone draw (see N for each week in table below).||Percent of Participants|||Number
836535|NCT01296152|Primary|AUC0-12hour for LPV at Baseline (Day 0) Before DMPA Administration and at Week 4 (Four Weeks After DMPA Administration)|This evaluates the effect of DMPA on LPV PK parameter AUC by comparing PK AUCs of LPV from 0 to 12 hours obtained at study Day 0 (before DMPA was administered) with PK AUCs of LPV from 0 to 12 hours at study Week 4 (4 weeks after DMPA was administered). Blood samples were drawn for LPV concentration levels at time zero (before LPV/r dosing) and at 30 minutes and 1, 2, 3, 4, 5, 6, 8 and 10 hours after LPV/r dosing at day 0 and week 4.|Day 0 and Week 4|All participants eligible for the first primary PK outcome measure (MPA AUC0-12weeks) were included in this second primary outcome measure looking at LPV AUC0-12hours at Day 0 and week 4.||ng*h/mL||Full Range|Median
836536|NCT01296152|Primary|Medroxyprogesterone Acetate (MPA) Pharmacokinetic Parameter (PK) Area Under the Concentration-time Curve (AUC0-12weeks)|This evaluates the effect of lopinavir/ritonavir (LPV/r) on pharmacokinetic parameter AUC of MPA by looking at the MPA AUC from day 0 to week 12. AUC0-12weeks was calculated using single MPA concentrations sampled immediately prior to DMPA administration on day 0, and at 2, 4, 6, 8, 10 and 12 weeks after administration of the single DMPA dose.|Day 0, Weeks 2, 4, 6, 8, 10 and 12|One participant was excluded from all PK analyses for taking a prohibited medication with potential to interfere with PK assessments. For another participant who missed week 10 and 12 visits, a modelling approach was used to estimate the week 12 MPA level.||ng*wk/mL||Full Range|Median
836537|NCT01283971|Secondary|Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs), Discontinuation Due to AEs and Deaths|"An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events.
A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant."|32 weeks|Safety Population included all participants who received study drug and who had at least 1 post-dose safety assessment.||Participants|||Number
836538|NCT01283971|Secondary|Change From Baseline in Hemoglobin at Week 24|Blood was collected at Baseline and Week 24. The samples were sent to a central laboratory for Hemoglobin analysis reported in gram/deciliter (g/dL). A positive number change from Baseline (a higher hemoglobin level compared to Baseline) indicated improvement|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment, with hemoglobin data available at Baseline and Week 24.||g/dL||Standard Deviation|Mean
836547|NCT01283971|Secondary|Change From Baseline in Patient Assessment of Pain Visual Analog Scale (VAS) at Week 24|"The patient assessed their pain using a 0 to 100 millimeter (mm) horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 mm, and is described as no pain and the right-hand extreme equals 100 mm as unbearable pain. A negative change from Baseline indicated improvement."|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment, with data available at Baseline and Week 24.||Score on a scale||Standard Deviation|Mean
836579|NCT01284114|Primary|The Change of Heart Function Confirmed by Echocardiograph|Left ventricular ejection fraction (LVEF)were measured by echocardiogram at baseline and 6 month. Plasma BNP level were measured by the radioimmunoassay (RIA) method at baseline and 6month.|baseline and 6 month|We analyzed participants who copmleted this study||% of stroke vulume/enddiastolic volume||Standard Deviation|Mean
836539|NCT01283971|Secondary|Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Score at Week 24|RAPID3 is a patient self reported assessment that combines the HAQ-DI [20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities. Each domain has at least 2 component questions answered on a 4-point scale where 0=without any difficulty to 3=unable to do} converted to a score of 0-10, the Patients Assessment of Pain [Over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain] converted to a score of 0-10 and the Patient's Global Assessment of Disease Activity [over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity] converted to a score of 0-10. The 3 individual scales are summed for a raw score of 0-30 which is divided by 3 to achieve a total possible adjusted score of 0-10. A negative change from Baseline indicates improvement.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment, with data available at Baseline and Week 24 for this outcome measure.||Score on a scale||Standard Deviation|Mean
836540|NCT01283971|Secondary|Change From Baseline in Quality of Life Short Form (SF-36) Score at Week 24|The SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from baseline indicates improvement.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment, with data available at Baseline and Week 24 for this outcome measure.||Score on a scale||Standard Deviation|Mean
836541|NCT01283971|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-Fatigue) Score at Week 24|FACIT-F is a 13-item questionnaire. Patients scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the patient's response to the questions (with the exception of 2 negatively stated), the greater the patient's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the patient's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the patient's health status. A positive change from Baseline indicates improvement.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment, with data available at Baseline and Week 24.||Score on a scale||Standard Deviation|Mean
836542|NCT01283971|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24|The Stanford Health Assessment Questionnaire Disability Index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis, consisting of 20 questions in 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. There are 4 possible responses for each question: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty and 3=unable to do. The score for each of the domains is the highest (worst) score in each domain. A patient must have a domain score for at least 6 of 8 domains to calculate a valid HAQ-DI score which is the sum of domain scores, divided by the number of domains that have a score for a total possible score minimum/maximum 0 (best) to 3 (worst). A negative change from Baseline indicated improvement.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment, with data available at Baseline and Week 24.||Score on a scale||Standard Deviation|Mean
836543|NCT01283971|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 24|Blood was collected for Erythrocyte Sedimentation Rate (ESR) (a test that assesses tissue inflammation) and was analyzed at a local laboratory. ESR was measured in millimeter/hour (mm/hr). A reduction in the level is considered an improvement.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment, with data available at Baseline and Week 24 for this outcome measure.||mm/hr||Standard Deviation|Mean
836544|NCT01283971|Secondary|Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) at Week 24|Blood was collected for C-Reactive Protein (CRP) (a test for analysis of inflammatory and infectious disorders) and was analyzed at a central laboratory. The concentration of CRP was measured in milligram/liter (mg/L). A reduction in the level is considered an improvement|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment, with data available at Baseline and Week 24 for this outcome measure.||mg/L||Standard Deviation|Mean
836545|NCT01283971|Secondary|Change From Baseline in the Physician Global Assessment of Disease Activity VAS at Week 24|"The physician global assessment of disease activity was assessed using a 0 to 100 mm horizontal visual analogue scale (VAS) by the physician. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). A negative change from Baseline indicated improvement."|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment, with data available at Baseline and Week 24.||Score on a scale||Standard Deviation|Mean
836546|NCT01283971|Secondary|Change From Baseline in the Patient Global Assessment of Disease Activity VAS at Week 24|"The patient's global assessment of disease activity is assessed on a 0 to 100 millimeter (mm) horizontal visual analogue scale (VAS) by the patient. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). A negative change from Baseline indicated improvement."|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment, with data available at Baseline and Week 24.||Score on a scale||Standard Deviation|Mean
836580|NCT01284114|Primary|The Change of Blood Pressure|The change of systolic blood pressure and diastolic blood pressure|baseline and 6 month|We analyzed all patients who completed study.||mmHg||Standard Deviation|Mean
836548|NCT01283971|Secondary|Change From Baseline in Tender Joint Count (TJC) at Week 24|68 joints are assessed for tenderness and joints are classified as tender/not tender giving a total possible tender joint count score of 0 to 68. A negative change from Baseline indicated improvement.|Baseline, Week 24|Intent-to-treat population included all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment. Last observation carried forward was used to impute missing tender joint counts.||Joint count||Standard Deviation|Mean
836549|NCT01283971|Secondary|Change From Baseline in Swollen Joint Count (SJC) at Week 24|66 joints were assessed for swelling and joints are classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66. A negative change from Baseline indicated improvement.|Baseline, Week 24|Intent-to-treat population included all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment. Last observation was used to impute missing swollen joint counts.||Joint count||Standard Deviation|Mean
836550|NCT01283971|Secondary|Change From Baseline in DAS28 Score at Week 24|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 2 to 10. A higher value indicated higher disease activity. A negative change from Baseline indicated improvement.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment, with data available at Baseline and Week 24. Last observation carried forward was used to impute missing tender and swollen joint counts. All other DAS28 components were used as observed.||Score on a scale||Standard Deviation|Mean
836551|NCT01283971|Secondary|Percentage of Participants With DAS28 Low Disease Activity (LDAS) at Week 24|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 2 to 10. LDAS is defined as DAS28 ≤3.2.|Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment, with data available at Baseline and Week 24. Last observation carried forward was used to impute missing tender and swollen joint counts. All other DAS28 components were used as observed.||Percentage of participants|||Number
836552|NCT01283971|Secondary|Percentage of Participants With Good or Moderate European League Against Rheumatism (EULAR) DAS28 Responses at Week 24|The DAS28 score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity (mm), and ESR. DAS28 total score ranges from 0 (best) to 10 (worst). A negative change from Baseline indicated improvement. European League Against Rheumatism (EULAR) Good response: DAS28 ≤ 3.2 or a change from Baseline < -1.2. EULAR Moderate response: DAS28 >3.2 to ≤ 5.1 or a change from Baseline < -0.6 to ≥ -1.2.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment, with data available at Week 24. Last observation carried forward was used to impute missing tender and swollen joint counts. All other EULAR components were used as observed.||Percentage of participants|||Number
836553|NCT01283971|Secondary|Percentage of Participants With ACR70 Response at Week 24|ACR70 response is defined as a ≥ 70% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant Erythrocyte Sedimentation Rate.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment, with ACR score data available. Last observation carried forward was used to impute missing tender and swollen joint counts. All other ACR components were used as observed.||Percentage of participants|||Number
836554|NCT01283971|Secondary|Percentage of Participants With ACR50 Response at Week 24|ACR50 response is defined as a ≥ 50% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant Erythrocyte Sedimentation Rate.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment, with ACR score data available. Last observation carried forward was used to impute missing tender and swollen joint counts. All other ACR components were used as observed.||Percentage of participants|||Number
836563|NCT01284062|Secondary|Number of Participants With Anti-drug Antibody (ADA) and Neutralizing Antibody|Neutralizing antibody was not analyzed as no participant had positive ADA samples.|Day 1, Week 4, 8, 12, 14, 16, 20, 24, 28, 32|mITT: all randomized participants who received >=1 dose study drug; DAO: all mITT participants with all data needed for calculation of specified endpoint. “Number of Participants Analyzed” signifies participants in mITT population; “n” signifies participants in mITT DAO population for specified time point.||participants|||Number
836564|NCT01284062|Secondary|Number of Participants Who Discontinued From the Study Due to Adverse Events||Baseline up to Week 32|Safety analysis set included all randomized participants who received at least 1 dose of study treatment.||participants|||Number
836555|NCT01283971|Secondary|Percentage of Participants With American College of Rheumatology (ACR20) Response at Week 24|ACR20 response is defined as a ≥ 20% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant Erythrocyte Sedimentation Rate.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment, with ACR score data available. Last observation carried forward was used to impute missing tender and swollen joint counts. All other ACR components were used as observed.||Percentage of participants|||Number
836556|NCT01283971|Primary|Percentage of Participants With Disease Activity Score 28 Joints (DAS28) Remission at Week 24|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 2 to 10. DAS28 Remission is defined as a DAS28 score <2.6.|Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment, with data available at Baseline and Week 24. Last observation carried forward was used to impute missing tender and swollen joint counts. All other ACR components were used as observed.||Percentage of participants|||Number
836557|NCT01284062|Secondary|Number of Participants With Change From Baseline in Endoscopic Subscore at Week 14|Mayo score is used to measure the disease activity of ulcerative colitis. Endoscopy or flexible sigmoidoscopy is a sub score of Mayo score. The score for endoscopic subscore ranges from 0 to 3, where higher score indicates more severe disease activity. Participant’s score for endoscopy or flexible sigmoidoscopy at Week 14 was specified as improved (decrease), no change and worsened (increase) compared to their baseline score.|Baseline, Week 14|mITT: all randomized participants who received >=1 dose study drug; DAO: all mITT participants with all data needed for calculation of specified endpoint. “Number of Participants Analyzed” signifies participants in the mITT DAO population for specified endpoint.||participants|||Number
836558|NCT01284062|Other Pre-specified|Number of Participants With Change From Baseline in Rectal Bleeding at Week 14|Mayo score is used to measure the disease activity of ulcerative colitis. Rectal bleeding is a sub score of Mayo score. The score for rectal bleeding ranges from 0 to 3, where higher score indicates more severe disease activity. Participant’s score for rectal bleeding at Week 14 was specified as improved (decrease), no change and worsened (increase) compared to their baseline score.|Baseline, Week 14|mITT: all randomized participants who received >=1 dose study drug; DAO: all mITT participants with all data needed for calculation of specified endpoint. “Number of Participants Analyzed” signifies participants in the mITT DAO population for specified endpoint.||participants|||Number
836559|NCT01284062|Other Pre-specified|Number of Participants With Change From Baseline in Stool Frequency at Week 14|Stool frequency is a sub score of Mayo score used to measure the disease activity of ulcerative colitis. The score for stool frequency ranges from 0 to 3, where higher score indicates more severe disease activity. Participant’s score for stool frequency at Week 14 was specified as improved (decrease), no change and worsened (increase) compared to their baseline score.|Baseline, Week 14|mITT: all randomized participants who received >=1 dose study drug; DAO: all mITT participants with all data needed for calculation of specified endpoint. “Number of Participants Analyzed” signifies participants in the mITT DAO population for specified endpoint.||participants|||Number
836560|NCT01284062|Other Pre-specified|Change From Baseline in Total Mayo Score at Week 14|The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, findings on flexible sigmoidoscopy [endoscopy] and physician’s global assessment), each subscore is graded from 0 to 3 with the higher score indicating more severe disease activity.|Baseline, Week 14|mITT: all randomized participants who received >=1 dose study drug; DAO: all mITT participants with all data needed for calculation of specified endpoint. “Number of Participants Analyzed” signifies participants in the mITT DAO population for specified endpoint.||unit on a scale||95% Confidence Interval|Least Squares Mean
836561|NCT01284062|Other Pre-specified|Clinical Remission Rate at Week 14|Clinical remission rate is defined as percentage of participants with a total Mayo score less than or equal to 2, with no individual subscore greater than 1 at post baseline visit. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, findings on flexible sigmoidoscopy and physician’s global assessment), each subscore is graded from 0 to 3 with the higher score indicating more severe disease activity.|Week 14|mITT: all randomized participants who received >=1 dose study drug; DAO: all mITT participants with all data needed for calculation of specified endpoint. “Number of Participants Analyzed” signifies participants in the mITT DAO population for specified endpoint.||percentage of participants||95% Confidence Interval|Number
836562|NCT01284062|Other Pre-specified|Clinical Response Rate at Week 14|Clinical response rate is defined as percentage of participants with at least 3 point decrease from baseline in total Mayo score with at least 30% change along with 1 point decrease from baseline or absolute score of 0 or 1 in rectal bleeding. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, findings on flexible sigmoidoscopy [endoscopy] and physician’s global assessment), each subscore is graded from 0 to 3 with the higher score indicating more severe disease activity.|Week 14|mITT: all randomized participants who received >=1 dose study drug; DAO: all mITT participants with all data needed for calculation of specified endpoint. “Number of Participants Analyzed” signifies participants in the mITT DAO population for specified endpoint.||percentage of participants||95% Confidence Interval|Number
836578|NCT01284114|Primary|The Change of BNP|Plasma BNP level were measured by the radioimmunoassay (RIA) method at baseline and 6month.|baseline and 6month|We analyzed all patients who completed study.||pg/ml||Standard Deviation|Mean
836565|NCT01284062|Secondary|Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Week 32 that were absent before treatment or that worsened relative to pretreatment state. All causality AEs included SAEs as well as non-serious AEs, without regard to relationship to the study drug, which occurred during the trial.|Baseline up to Week 32|Safety analysis set included all randomized participants who received at least 1 dose of study treatment.||participants|||Number
836566|NCT01284062|Secondary|Total Interleukin-13 (IL-13) Level||Baseline, Day 2, 4, 7, Week 2, 4, 8, 12, 14, 16, 20, 24, 28, 32|mITT: all randomized participants who received >=1 dose study drug; DAO: all mITT participants with all data needed for calculation of specified endpoint. “Number of Participants Analyzed” signifies participants in mITT population; “n” signifies participants in mITT DAO population for specified time point.||picogram/milliliter||Standard Deviation|Mean
836567|NCT01284062|Secondary|Fold Change From Baseline in Fecal Calprotectin at Week 2, 4, 8 and 12|The fold change from baseline in fecal calprotectin at post-baseline visit, is the ratio of the measurement of fecal calprotectin at post-baseline visit to baseline measurement; this was calculated as the change from baseline in natural log transformed fecal calprotectin at post-baseline visit.|Baseline, Week 2, 4, 8, 12|mITT: all randomized participants who received >=1 dose study drug; DAO: all mITT participants with all data needed for calculation of specified endpoint. “Number of Participants Analyzed” signifies participants in mITT population; “n” signifies participants in mITT DAO population for specified time point.||fold change||95% Confidence Interval|Least Squares Mean
836568|NCT01284062|Secondary|Volume of Distribution (Vz) for Anrukinzumab|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.|Pre-dose, within 1 hour post-end of infusion on Week 12; Week 14, 16, 18, 20, 22, 24, 26, 28, 30, 32|"All participants with evaluable PK results were included in PK population. PK samples with time deviation >20% from nominal time were excluded from statistical summary and PK analysis. “Number of participants analyzed signifies those participants who were evaluable for this outcome measure."||liters||Standard Deviation|Mean
836569|NCT01284062|Secondary|Systemic Clearance (CL) for Anrukinzumab|CL is a quantitative measure of the rate at which a drug substance is removed from the body.|Pre-dose, within 1 hour post-end of infusion on Week 12; Week 14, 16, 18, 20, 22, 24, 26, 28, 30, 32|"All participants with evaluable PK results were included in PK population. PK samples with time deviation >20% from nominal time were excluded from statistical summary and PK analysis. “Number of participants analyzed signifies those participants who were evaluable for this outcome measure."||liters/day||Standard Deviation|Mean
836570|NCT01284062|Secondary|Plasma Decay Half-Life (t1/2) for Anrukinzumab|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Within 1 hour post-end of infusion on Week 12; Week 14, 16, 18, 20, 22, 24, 26, 28, 30, 32|"All participants with evaluable PK results were included in PK population. PK samples with time deviation >20% from nominal time were excluded from statistical summary and PK analysis. “Number of participants analyzed signifies those participants who were evaluable for this outcome measure."||hours||Standard Deviation|Mean
836571|NCT01284062|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Anrukinzumab|Area under the plasma concentration curve from time zero to end of dosing interval (2 weeks) was reported.|Pre-dose, within 1 hour post-end of infusion on Day 1; Day 2, 4, 7, pre-dose on Week 2|"All participants with evaluable PK results were included in PK population. PK samples with time deviation >20% from nominal time were excluded from statistical summary and PK analysis. Number of participants analyzed signifies those participants who were evaluable for this outcome measure."||nanogram*hour/milliliter (ng*hr/mL)||Standard Deviation|Mean
836572|NCT01284062|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) for Anrukinzumab|Lowest concentration observed during the dosing interval (2 weeks for day 1, 4 weeks for week 12).|Pre-dose to end of the dosing interval after Day 1, Week 12|"All participants with evaluable PK results were included in PK population. PK samples with time deviation >20% from nominal time were excluded from statistical summary and PK analysis. “Number of participants analyzed” signifies participants in PK population; n signifies evaluable participants at specified time point."||ng/mL||Standard Deviation|Mean
836573|NCT01284062|Secondary|Maximum Observed Plasma Concentration (Cmax) for Anrukinzumab|Maximum concentration observed during the dosing interval (2 weeks for day 1, 4 weeks for week 12).|Pre-dose to end of the dosing interval after Day 1, Week 12|"All participants with evaluable pharmacokinetic (PK) results were included in PK population. PK samples with time deviation greater than (>) 20 percent (%) from nominal time were excluded from statistical summary and PK analysis. “Number of participants analyzed” = participants in PK population; n = evaluable participants at specified time point."||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
836574|NCT01284062|Primary|Fold Change From Baseline in Fecal Calprotectin at Week 14|The fold change from baseline in fecal calprotectin at Week 14, is the ratio of the measurement of fecal calprotectin at Week 14 to baseline measurement; this was calculated as the change from baseline in natural log transformed fecal calprotectin at Week 14.|Baseline, Week 14|Modified Intent to Treat (mITT: all randomized participants who received greater than or equal to [>=] 1 dose study drug); Data as Observed (DAO: all mITT participants with all data needed for calculation of specified endpoint). “Number of Participants Analyzed” signifies participants in the mITT DAO population for specified endpoint.||fold change||95% Confidence Interval|Least Squares Mean
836575|NCT01284114|Primary|The Change of Urine Albumin/ Creatinine Ratio (UACR).|The UACR was measured at baseline, Week12 and Week24|baseline and 6 months|We analyzed all patients who completed this study.||mg/g||Standard Deviation|Mean
836576|NCT01284114|Primary|The Change of eGFR|eGFR was calculated at baseline and at 6 month using a modified version of the Modification of Diet in Renal Disease (MDRD) formula of the Japanese Society of Nephrology as follows: eGFR (ml/min/1.73 m2) = 194 × age-0.287 × serum creatinine-1.094 (multiplied by 0.739 for females).|baseline and 6 month|We analyzed all patients who completed study.||mL/min/1.73m2||Standard Deviation|Mean
836577|NCT01284114|Secondary|The Change of Oxidative Stress Markers Confirmed by Plasma Level of 8-OHdG and d-ROM||6 months||||||
836581|NCT01284244|Primary|A 50% Reduction in Pad Test Weight|"A pad test is an objective measure of urine loss. With a full bladder, while wearing a pad, the participant completes five repetitions of the following physical activities: coughing, step climbing, heel bounce, standing from a sitting position and walking 50 yards. The weight of the pad is then determined.
The primary outcome variable will be the achievement of a 50% reduction in the pad weight before and after device placement. This figure is obtained from the study by Farrell et al, where pad weight decreased from 20 grams to 9 grams with the use of the Uresta device."|Immediately after device placement (short term).|||Participants|||Count of Participants
836582|NCT01289639|Secondary|Change in Hepatic Insulin Sensitivity|Hepatic insulin sensitivity was determined using stable glucose isotope measurements during the low dose hyperinsulinemic euglycemic clamp to determine the rate of endogenous glucose production in the fasting state and in response to a low dose glucose infusion. The ability of insulin to suppress glucose, which is mainly produced by the liver, thus provides a measure of hepatic insulin sensitivity and is expressed as a percentage of the basal state. Change in the ability of low dose insulin to suppress endogenous glucose production during a labeled hyperinsulinemic euglycemic clamp.|0-6 months|||% change from baseline||Standard Error|Mean
836583|NCT01289639|Secondary|Change in Intra-abdominal Fat Area by CT Scan||0-6 months|||mm2||Standard Error|Mean
836584|NCT01289639|Secondary|Change in Peripheral Insulin Sensitivity|Change in the rate of glucose disposal (Rd) during the low dose clamp. During a clamp procedure, insulin is infused at a dose based on body size and a glucose solution is infused and the rate adjusted every 5 minutes based on a blood glucose reading to maintain the blood glucose stable at 90 mg/dl (normal level). Using glucose isotopes and the rate of the glucose infusion, we are then able to calculate how much glucose the liver is producing and how much glucose is being taken up into tissues. This provides a measure of insulin sensitivity.|0-6 months|||mg/minute/kg lean mass||Standard Error|Mean
836585|NCT01289639|Secondary|Change in Liver/Spleen Ratio Measure by the Density Ratio in Hounsfield Units Between the Liver and the Spleen by CT||0-6 months|||ratio||Standard Error|Mean
836586|NCT01289639|Secondary|Change in Alanine Aminotransferase (ALT) Levels||0-6 months|||U/L||Standard Error|Mean
836587|NCT01289639|Primary|Liver/Spleen Ratio Measured as the Ratio in Hounsfield Units Between the Liver and the Spleen on Computed Tomography (CT) Scan||6 months|||ratio||Standard Error|Mean
836588|NCT01289782|Secondary|Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) in Work Productivity and Activity (WPAI) Absenteeism Scores Due to Hepatitis C Virus (HCV) Infection and Its Treatment|Time missed from work in hours because of HCV infection or its treatment was assessed by measuring the change from baseline in the Work Productivity and Activity Impairment (WPAI): Hepatitis C questionnaire Absenteeism score (time missed from work, question #2). The number of hours missed from work because of HCV was divided by the total number of hours supposed to work, and expressed as a percentage. An area under the curve (AUC) analysis compared the WPAI absenteeism scores in each treatment group from Baseline to Week 72. The null hypothesis was that there would be no difference between the treatment arms WPAI absenteeism scores from Baseline to Week 72. The Table below shows the lease squares (LS) mean estimates of AUC at Week 72 (as well as at Week 60) in WPAI absenteeism scores and the statistical comparison between treatment groups.|Baseline to Week 60 and Week 72|Analysis Population Description: The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||scores on a scale*weeks||95% Confidence Interval|Least Squares Mean
836589|NCT01289782|Secondary|Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) for Impairment in Daily Activity Scores Due to Hepatitis C Virus (HCV) Infection and Its Treatment|Impairment in daily activity was measured using the Work Productivity and Activity Impairment (WPAI): Hepatitis C questionnaire, Question 6. Scores ranged from 0 (no effect on activities) to 10 (completely prevented me from doing my daily activities). An area under the curve (AUC) analysis compared the impairment in daily activity scores in each treatment group from Baseline to Week 72. The null hypothesis was that there would be no difference between the treatment arms in impairment in daily activity scores from Baseline to Week 72. The Table below shows the lease squares (LS) mean estimates of AUC at Week 72 (as well as at Week 60) in the impairment in daily activity scores and the statistical comparison between treatment groups.|Baseline to Week 60 and Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||scores on a scale*weeks||95% Confidence Interval|Least Squares Mean
836590|NCT01289782|Secondary|Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) for Impairment in Overall Work Productivity Scores Due to Hepatitis C Virus (HCV) Infection and Its Treatment|Impairment in overall work productivity was measured using the Work Productivity and Activity Impairment (WPAI): Hepatitis C questionnaire completed by participants during study visits throughout the study. WPAI Overall Productivity Scores ranged from 0% to 100% (higher WPAI scores indicated greater impairment in productivity). An area under the curve (AUC) analysis compared the overall WPAI Overall Work Productivity Scores in each treatment group from Baseline to Week 72. The null hypothesis was that there would be no difference between the treatment arms in the WPAI Overall Work Productivity Scores from Baseline to Week 72. The Table below shows the lease squares (LS) mean estimates of AUC at Week 72 (as well as at Week 60) in WPAI Work Productivity Scores and the statistical comparison between treatment groups.|Baseline to Week 60 and Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||scores on a scale*weeks||95% Confidence Interval|Least Squares Mean
836602|NCT01289782|Secondary|Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable or Detectable|The table below shows median time in days to reach HCV RNA levels <25 IU/mL undetectable or detectable.|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Days||95% Confidence Interval|Median
836603|NCT01289782|Secondary|Percentage of Participants With On-treatment Failure|The table below shows percentage of participants with on-treatment failure defined as confirmed detectable Hepatitis C virus ribonucleic acid levels at actual end of treatment.|Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
836591|NCT01289782|Secondary|Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) for the Fatigue Severity Scale (FSS) Total Scores|Study participants completed FSS questionnaires during study visits before treatment began and throughout treatment and follow-up to rate the severity and impact of fatigue they experienced in the preceding 2 weeks on their daily lives. FSS total scores are the average of nine questions with a range from 1 [no fatigue] to 7 [worst possible fatigue]. An area under the curve (AUC) analysis compared the overall severity of fatigue in each treatment group from baseline to Week 72. The null hypothesis was that there would be no difference between the treatment arms in the amount of fatigue participants experienced throughout the study resulting in equal AUC from baseline to Week 72 (AUC72) for FSS total scores. The Table below shows the lease squares (LS) mean estimates of AUC at Week 72 (as well as at Week 60) and the statistical comparison between treatment groups.|Baseline to Week 60 and Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||scores on a scale*weeks||95% Confidence Interval|Least Squares Mean
836592|NCT01289782|Secondary|Plasma Concentration of TMC435: Systemic Clearance (CL)|The table below shows the mean (standard deviation) values for the CL of TMC435.To calculate the mean CL for all participants in the study, CL values were first derived for each participant at each visit and then a median CL value calculated across visits for each participant. The median CL value for each participant was used to calculate the mean CL for all participants in the study.|Across Weeks 2, 4, 8, and 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||L/h||Standard Deviation|Mean
836593|NCT01289782|Secondary|Plasma Concentration of TMC435: Predose Plasma Concentration (C0h)|The table below shows the mean (standard deviation) values for the C0h of TMC435.To calculate the mean C0h for the study, C0h values were derived for each participant at each visit and then a median C0H value calculated across visits for each participant. The median COh value for each participant across all visits was used to calculate the mean C0h for the study.|Before administration of TMC435 at Weeks 2, 4, 8, and 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||ng/mL||Standard Deviation|Mean
836594|NCT01289782|Secondary|Plasma Concentration of TMC435: Area Under the Plasma Concentration-time Curve From the Time of Administration to 24 Hours After Dosing (AUC24h)|The table below shows mean (standard deviation) values of the area under the plasma concentration-time curve from time of administration to 24 hours after dosing for TMC435 for all participants. To calculate the mean AUC 24 for the study, AUC 24 hr values were derived for each participant at each visit and then a median AUC value calcuated across all visits for each participant. The median AUC value across all visits for each participant was used to calculate the mean AUC 24 hr all participants in the study.|Fom the time of administration up to 24 hours after dosing at Weeks 2, 4, 8, and 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||ng*h/mL||Standard Deviation|Mean
836595|NCT01289782|Secondary|Median Time to Normalization of Alanine Aminotransferase (ALT) Levels|The table below shows the median time in weeks to normalization of ALT levels.|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Weeks||95% Confidence Interval|Median
836596|NCT01289782|Secondary|The Percentage of Participants With Normalization of Alanine Aminotransferase (ALT)|The percentage of participants analyzed were those with baseline ALT values out of the normal range (ie, 158 of 264 participants in the TMC435 treatment group and 89 of 130 participants in the Placebo group had ALT values at baseline that were out of the normal range.). Normalization of ALT values means that ALT values out of the normal range returned to within the normal range.|Up to Week 48|Participants with baseline ALT values out of normal range were used for this analysis from intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication).||Percentage of participants|||Number
836597|NCT01289782|Secondary|Time From End-of-treatment to Viral Relapse|The table below shows the mean number of days to viral relapse, defined as participants having confirmed detectable plasma level of Hepatitis C Virus (HCV) ribonucleic acid (RNA) during the follow-up period in participants with undetectable plasma HCV RNA (<25 IU/mL undetectable) at the end of treatment.|Up to Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Days||Standard Error|Mean
836598|NCT01289782|Secondary|The Percentage of Participants With Viral Breakthrough at Different Time Points|The table below shows the percentage of participants at different time points with viral breakthrough, defined as a confirmed increase of greater than 1 log10 IU/mL in plasma HCV ribonucleic acid (RNA) level from the lowest level reached (ie, lowest value measured in between baseline and current value), or a confirmed plasma HCV RNA level of greater than 100 IU/mL in participants whose plasma HCV RNA had previously been below the limit of quantification (25 IU/mL detectable) or undetectable (<25 IU/mL undetectable).|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
836599|NCT01289782|Secondary|Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <1000 IU/mL|The table below shows median time in days to reach HCV RNA levels <1000 IU/mL.|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Days||95% Confidence Interval|Median
836600|NCT01289782|Secondary|Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <100 IU/mL|The table below shows median time in days to reach HCV RNA levels <100 IU/mL.|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Days||95% Confidence Interval|Median
836601|NCT01289782|Secondary|Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable|The table below shows median time in days to reach HCV RNA levels <25 IU/mL undetectable.|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Days||95% Confidence Interval|Median
836628|NCT01289847|Secondary|Therapeutic Efficacy|Number of days on therapeutic antibiotics|12 months|||days||Standard Deviation|Mean
836629|NCT01289847|Secondary|Therapeutic Efficacy|Visits to physicians and/or emergency room|12 months|||visits||Standard Deviation|Mean
836604|NCT01289782|Secondary|Percentage of Participants Who Completed All Study Treatment at Week 24 Because of the Treatment Duration Rule|The table below shows the percentage of participants in the TMC435 treatment group who met the treatment duration rule (ie, having hepatitis C virus [HCV] ribonucleic acid [RNA] levels <25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA levels at Week 12) and completed treatment with PegIFNα-2a and RBV for 24 weeks. Participants in the TMC435 treatment group not meeting RGT criteria and participants in the placebo group were treated with PegIFNα-2a and RBV treatment for 48 weeks.|Week 24|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
836605|NCT01289782|Secondary|Percentage of Participants With Viral Relapse|The table below shows the percentage of participants with viral relapse, defined as having confirmed detectable plasma level of Hepatitis C virus (HCV) ribonucleic acid (RNA) during the follow-up period in participants with undetectable plasma HCV RNA (less than 25 IU/mL undetectable) at the end of treatment.|Up to Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
836606|NCT01289782|Secondary|Percentage of Participants With Viral Breakthrough|The table below shows the percentage of participants with viral breakthrough, defined as a confirmed increase of greater than 1 log10 IU/mL in plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) level from the lowest level reached (ie, lowest value measured in between baseline and current value), or a confirmed plasma HCV RNA level of greater than 100 IU/mL in participants whose plasma HCV RNA had previously been below the limit of quantification (25 IU/mL detectable) or undetectable (<25 IU/mL undetectable).|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
836607|NCT01289782|Secondary|Percentage of Participants With Partial Response|The table below shows the percentage of participants with partial response, defined as greater than or equal to 2 log10 reduction in Hepatitis C virus ribonucleic acid at Week 12 compared to baseline, but not achieving undetectable HCV RNA while on treatment.|Week 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
836608|NCT01289782|Secondary|Percentage of Participants With Null Response|The table below shows the percentage of participants with null response, defined as <2 log10 reduction in Hepatitis C virus ribonucleic acid at Week 12 compared to baseline.|Week 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
836609|NCT01289782|Secondary|Percentage of Participants With in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels >1000 IU/mL at Week 4|The table below shows the percentage of participants in each treatment group with HCV RNA levels >1000 IU/mL at Week 4.|Week 4|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
836610|NCT01289782|Secondary|The Percentage of Participants With <1 log10 Decrease in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) From Baseline at Week 4|The table below shows the percentage of participants in each treatment group with <1 log10 HCV RNA decrease at Week 4.|Week 4|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
836611|NCT01289782|Secondary|The Percentage of Participants Achieving a Extended Rapid Virologic Response (eRVR)|The table below shows the percentage of participants in each treatment group who had a eRVR, defined as having undetectable plasma Hepatitis C Virus ribonucleic acid levels at Week 4 and 12.|Week 4 and 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
836612|NCT01289782|Secondary|The Percentage of Participants Achieving a Complete Early Virologic Response (cEVR)|The table below shows the percentage of participants in each treatment group who had a cEVR, defined as having undetectable plasma Hepatitis C Virus ribonucleic acid levels at Week 12.|Week 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
836613|NCT01289782|Secondary|The Percentage of Participants Achieving a Early Virologic Response (EVR)|The table below shows the percentage of participants who achieved an EVR, defined as having a change from baseline in plasma Hepatitis C virus ribonucleic acid of greater than or equal to 2 log10 at Week 12.|Week 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
836614|NCT01289782|Secondary|The Percentage of Participants Achieving a Rapid Virologic Response (RVR)|The table below shows the percentage of participants in each treatment group who achieved a RVR, defined as having undetectable plasma Hepatitis C virus ribonucleic acid levels after receiving 4 weeks of treatment.|Week 4|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
836615|NCT01289782|Secondary|Percentage of Participants With On-treatment Virologic Response at All Time Points|The table below shows the percentage of participants with Hepatitis C virus (HCV) ribonucleic acid (RNA) plasma levels below the limit of detection (ie, <25 IU/mL undetectable), the percentage of participants with a HCV RNA plasma level below the limit of quantification (ie, < 25 IU/mL detectable or undetectable), the percentage of participants with plasma levels of HCV RNA <100 IU/mL, the percentage of participants with virologic responses of a greater than or equal to 2 log10 change from baseline in plasma levels of HCV RNA.|Day 3, Week 1, Week 2, Week 8, Week 16, Week 20, Week 28, Week 36, and Week 42|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
836616|NCT01289782|Secondary|Actual Values of log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)|The table below shows actual values of log10 HCV RNA levels.|Day 3, Week 1, Week 4, Week 12, Week 24, and Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||log10 IU/mL||Standard Error|Mean
836617|NCT01289782|Secondary|Change From Baseline in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)|The table below shows the change from baseline in log10 HCV RNA levels.|Day 3, Week 1, Week 4, Week 12, Week 24, and Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||log10 IU/mL||Standard Error|Mean
836618|NCT01289782|Secondary|The Percentage of Participants Who Achieved a Sustained Virologic Response 4 Weeks After the Planned End of Treatment (SVR4)|The table below shows the percentage of participants in each treatment group who achieved a SVR4, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid levels 4 weeks after planned end of treatment.|Week 28 or Week 52|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
836619|NCT01289782|Secondary|The Percentage of Participants Who Achieved a Sustained Virologic Response 24 Weeks After the Planned End of Treatment (SVR24)|The table below shows the percentage of participants in each treatment group who achieved a SVR24, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid levels 24 weeks after planned end of treatment.|Week 48 or Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
836620|NCT01289782|Secondary|The Percentage of Participants Achieving a Sustained Virologic Response at Week 72 (SVRW72)|The table below shows the percentage of participants in each treatment group who achieved a SVRW72, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid levels at end of treatment (EOT) and at Week 72.|Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
836621|NCT01289782|Primary|The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12)|The table below shows the percentage of participants in each treatment group who achieved a SVR12, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid 12 weeks after planned end of treatment.|Week 36 or Week 60|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
836622|NCT01289821|Secondary|Duration of Stable Disease (DOSD)|DOSD was only evaluated in participants failing to achieve a best response of CR or PR, but who achieved SD. DOSR was defined as the time (in days) from date of start of study treatment to the date at which disease progression or death (if death occurred before progression was first documented). The date the tumor scan was performed was used for this calculation. DOSD for participants without disease progression or death before progression at the time of analysis were censored at the date of their last tumor assessment.|From start of treatment until 30 days after the last dose of study treatment, assessed by every 8 weeks|Per protocol set (PPS)||Days||95% Confidence Interval|Median
836623|NCT01289821|Secondary|Duration of Response (DOR)|DOR was defined as the time from the date of first documented objective response of PR or CR, whichever was noted earlier, to first subsequent disease progression or death (if death occurred before progression was documented). DOR was defined for responders only (that is, subjects with CR or PR). DOR for subjects without disease progression or death before progression was right censored at the date of their last tumor assessment.|From start of treatment until 30 days after the last dose of study treatment, assessed by every 8 weeks|Per protocol set (PPS)||Days||95% Confidence Interval|Median
836624|NCT01289821|Secondary|Disease Control (DC)|DC was defined as the proportion of participants who had a best response rating of CR, PR, or stable disease (SD) according to RECIST criteria that was achieved during treatment or within 30 days after termination of study treatment. CR and PR were confirmed not earlier than 4 weeks following the initial detection of response. A minimum of 8 weeks (allowing a minus 7-day time window) between start of study treatment and the first follow-up tumor assessment with SD as response was required to assign SD as best overall response.|From start of treatment until 30 days after the last dose of study treatment, assessed by every 8 weeks|PAS||Proportion of participants|||Number
836625|NCT01289821|Secondary|Progression-free Survival (PFS)|PFS was defined as time from the date of start of study treatment to the date of first observed disease progression (radiological according to central assessment or clinical), or death due to any cause, if death occurred before progression was documented. PFS for participants without disease progression or death at the date of database cutoff were right-censored at the last date of tumor assessment. Participants who had no tumor evaluation after baseline and no clinical progression post baseline and who did not die were censored at Day 1 in the analysis. PD = At least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of existing non target lesions or the appearance of one or more new lesions will also constitute PD.|From start of treatment until 30 days after the last dose of study treatment, assessed by every 8 weeks|Full analysis set (FAS)||Days||95% Confidence Interval|Median
836626|NCT01289821|Secondary|Overall Survival (OS)|OS was calculated as the time from first date of receiving study treatment to date of death due to any cause. Participants alive at the time of analysis were censored at their last date of follow-up.|From start of treatment until 30 days after the last dose of study treatment, assessed by every 8 weeks|Full analysis set (FAS, N=54) included all subjects who received treatment.||Days||95% Confidence Interval|Median
836627|NCT01289821|Primary|Objective Response (OR)|OR was defined as the best tumor response (confirmed complete response [CR] or partial response [PR]) observed by MRI or CT scan assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, version 1.1. CR and PR were confirmed not earlier than 4 weeks following the initial detection of response. CR = Disappearance of all clinical and radiological evidence of tumor (both target and no-target). Any pathological lymph nodes (whether target or non target) must have a reduction in short axis to < 10 mm. PR = At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum, no unequivocal progression of existing nontarget lesions and no appearance of new lesions.|From start of treatment until 30 days after termination of study medication, an average of 47 weeks. Assessed every 8 weeks.|Primary analysis set (PAS, N=41) was a subset of the PPS and included the first 41 subjects, who were assigned to treatment||Proportion of participants|||Number
836632|NCT01289847|Secondary|Therapeutic Efficacy|Number and proportion of subjects who maintain trough IgG levels at least as high as the average of the 2 previous trough levels before the first Gammaplex infusion|From week 15 onwards|Seven subjects (28.0%) maintained trough IgG levels at all visits that were at least as high as the average of the two previous levels before the first infusion||participants|||Number
836633|NCT01289847|Primary|Adverse Events|Number of subjects with serious, acute, bacterial infections as a measure of efficacy|12 months|Intent to Treat (ITT)||participants|||Number
836634|NCT01289990|Secondary|Fasting Plasma Glucose Change From Baseline After 76 Weeks of Treatment|Fasting plasma glucose - change from baseline after 76 weeks of treatment|Baseline and 76 weeks|Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline fasting plasma glucose assessment, irrespective of participation in the extension trial -LOCF||mg/dL||Standard Error|Least Squares Mean
836635|NCT01289990|Secondary|Fasting Plasma Glucose Change From Baseline After 52 Weeks of Treatment|Fasting plasma glucose - change from baseline after 52 weeks of treatment|Baseline and 52 weeks|Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline fasting plasma glucose assessment, irrespective of participation in the extension trial -LOCF||mg/dL||Standard Error|Least Squares Mean
836636|NCT01289990|Secondary|Waist Circumference (cm) Change From Baseline After 76 Weeks of Treatment|Waist circumference (cm) - change from baseline after 76 weeks of treatment|Baseline and 76 weeks|Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline waist circumference assessment, irrespective of participation in the extension trial -LOCF||cm||Standard Error|Least Squares Mean
836637|NCT01289990|Secondary|Waist Circumference (cm) Change From Baseline After 52 Weeks of Treatment|Waist circumference (cm) - change from baseline after 52 weeks of treatment|Baseline and 52 weeks|Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline waist circumference assessment, irrespective of participation in the extension trial -LOCF||cm||Standard Error|Least Squares Mean
836638|NCT01289990|Secondary|Body Weight (kg) Change From Baseline After 76 Weeks of Treatment|Body Weight (kg) - Change From Baseline After 76 Weeks of Treatment|Baseline and 76 weeks|Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline body weight assessment, irrespective of participation in the extension trial -LOCF||kg||Standard Error|Least Squares Mean
836639|NCT01289990|Secondary|Body Weight (kg) Change From Baseline After 52 Weeks of Treatment|Body Weight (kg) - Change From Baseline After 52 Weeks of Treatment|Baseline and 52 weeks|Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline body weight assessment, irrespective of participation in the extension trial. - LOCF||kg||Standard Error|Least Squares Mean
836640|NCT01289990|Secondary|Diastolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment|Diastolic blood pressure - change from baseline after 76 weeks of treatment|Baseline and 76 weeks|Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline diastolic blood pressure assessment, irrespective of participation in the extension trial -LOCF||mmHg||Standard Error|Least Squares Mean
836641|NCT01289990|Secondary|Diastolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment|Diastolic blood pressure - change from baseline after 52 weeks of treatment|Baseline and 52 weeks|Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline diastolic blood pressure assessment, irrespective of participation in the extension trial -LOCF||mmHg||Standard Error|Least Squares Mean
836642|NCT01289990|Secondary|Systolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment|Systolic blood pressure - change from baseline after 76 weeks of treatment|Baseline and 76 weeks|Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline systolic blood pressure assessment, irrespective of participation in the extension trial -LOCF||mmHg||Standard Error|Least Squares Mean
836643|NCT01289990|Primary|Changes From Baseline in HbA1c (%) After 76 Weeks of Treatment|Change from baseline in HbA1c after 76 weeks|Baseline and 76 weeks|Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline HbA1c assessment, irrespective of participation in the extension trial. (LOCF)||% of HbA1c||Standard Deviation|Least Squares Mean
836644|NCT01289990|Secondary|Systolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment|Systolic blood pressure - change from baseline after 52 weeks of treatment|Baseline and 52 weeks|Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline systolic blood pressure assessment, irrespective of participation in the extension trial. (LOCF)||mmHg||Standard Error|Least Squares Mean
836645|NCT01289990|Secondary|HbA1c (%) Changes From Baseline After 76 Weeks of Treatment|Change from baseline in HbA1c (%) after 76 weeks using MMRM approach|Baseline and 76 weeks|Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline HbA1c assessment, irrespective of participation in the extension trial. (OC: Observed cases)||% of HbA1c||Standard Error|Least Squares Mean
836646|NCT01289990|Primary|Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment|Change from baseline in HbA1c after 52 weeks|Baseline and 52 weeks|"Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline HbA1c assessment, irrespective of participation in the extension trial.
(LOCF:Last observation carried forward)"||% of HbA1c||Standard Error|Least Squares Mean
836647|NCT01290029|Secondary|Percent Change From Baseline in Ionized Calcium||Baseline (predose) and 2, 8, 12 and 48 hours post-dose.|"Due to the randomization to 1 of 2 sampling sequences not all participants had PD samples taken at every time point. n indicates participants with non-missing data at the time point of interest."||percent change||Standard Deviation|Mean
836648|NCT01290029|Secondary|Percent Change From Baseline in Albumin Corrected Calcium||Baseline (predose) and 2, 8, 12 and 48 hours post-dose.|"Due to the randomization to 1 of 2 sampling sequences not all participants had PD samples taken at every time point. n indicates participants with non-missing data at the time point of interest."||percent change||Standard Deviation|Mean
836649|NCT01290029|Secondary|Percent Change From Baseline in Total Calcium||Baseline (predose) and 2, 8, 12 and 48 hours post-dose.|"Due to the randomization to 1 of 2 sampling sequences not all participants had PD samples taken at every time point. n indicates participants with non-missing data at the time point of interest."||percent change||Standard Deviation|Mean
836650|NCT01290029|Secondary|Percent Change From Baseline in Intact Parathyroid Hormone||Baseline (predose) and at 2, 8, 12 and 48 hours post-dose.|"Due to the randomization to 1 of 2 sampling sequences not all participants had PD samples taken at every time point. n indicates participants with non-missing data at the time point of interest."||percent change||Inter-Quartile Range|Median
836651|NCT01290029|Secondary|Terminal Half-life of Cinacalcet|The terminal half-life (T1/2) of cinacalcet associated with the slope of the terminal phase.|Baseline (predose) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours post-dose|Pharmacokinetics analysis set; The T1/2 value for one participant was excluded based on the goodness-of-fit (R²) value exclusion criteria.||hours||Standard Deviation|Mean
836652|NCT01290029|Secondary|Time to Reach Maximum Observed Plasma Concentration of Cinacalcet (Tmax)||Baseline (predose) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours post-dose|Pharmacokinetics analysis set||hours||Full Range|Median
836653|NCT01290029|Secondary|Maximum Observed Plasma Concentration (Cmax) of Cinacalcet||Baseline (predose) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours post-dose|Pharmacokinetics analysis set||ng/mL||Standard Deviation|Mean
836654|NCT01290029|Secondary|Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUCinf) for Cinacalcet||Baseline (predose) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours post-dose|Pharmacokinetics analysis set; The AUCinf value for one participant was excluded based on the goodness-of-fit (R²) value exclusion criteria.||hr*ng/mL||Standard Deviation|Mean
836655|NCT01290029|Secondary|Area Under the Plasma Concentration Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) for Cinacalcet||Baseline (predose) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours post-dose|Pharmacokinetics analysis set||hr*ng/mL||Standard Deviation|Mean
836656|NCT01290029|Primary|Number of Participants With Adverse Events|A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria: • fatal • life threatening • requires in patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • congenital anomaly/birth defect • other medically important serious event. Treatment-related adverse events are those the investigator assessed as being possibly related to any study mandated activity (eg, administration of investigational product, protocol-required therapies, device(s) and/or procedure). Events of interest included acute pancreatitis, convulsions, drug related hepatic disorders, fractures, hypersensitivity, hypocalcemia, ischaemic heart disease, ventricular tachyarrhythmias, cardiac failure, and hypotension.|Day 1 to day 30|All participants who received at least 1 dose of cinacalcet.||participants|||Number
836657|NCT01290068|Secondary|Median Total Spectacle Cost Prior to Any Reimbursement|Total spectacle cost includes the frame, lens, and any reimbursement from national health systems or private insurance. Costs collected in pounds sterling were converted to euros.|Month 6 after second eye implantation|This analysis population includes all randomized and implanted participants. If total cost was missing for a spectacle independent subject, €0 was imputed. If total cost was missing for a spectacle-dependent subject, mean cost for all spectacle dependent-subjects in that group with a known total cost for the same type of spectacles was imputed.||euros||Inter-Quartile Range|Median
836658|NCT01290068|Primary|Mean Vision-Related Quality of Life as Reported on the NEI-RQL 42 (5 Dimensions)|Vision-related quality of life dimensions were evaluated using the National Eye Institute Refractive Error Quality of Life instrument (NEI-RQL 42), a self-administered questionnaire. Each dimension was scored between 0 to 100, with a higher score indicating a better vision-related Quality of Life. 5 of the dimensions were prespecified as primary.|Month 6 after second eye implantation|This analysis population includes all randomized participants to whom the randomized IOL was presented and/or implanted during the first eye surgery (from a try to a full success), as randomized.||units on a scale||Standard Error|Least Squares Mean
836659|NCT01290068|Primary|Proportion of Participants Reporting Spectacle Independence at All Distances|Spectacle independence at all distances; ie, where type of spectacles used/prescribed equaled ‘No spectacles’, was evaluated. If for the 6-month visit, spectacle type information was missing for the spectacle independence endpoint, but the subject attended this 6-month visit, subject was assumed to be spectacle independent.|Month 6 after second eye implantation|This analysis population includes all randomized participants to whom the randomized IOL was presented and/or implanted during the first eye surgery (from a try to a full success), as randomized. Last observation carried forward (LOCF) was used for missing data.||percentage of participants|||Number
836660|NCT01290068|Primary|Percentage of Participants Classified as Responders|Distance VA and near VA were measured binocularly (both eyes together) without visual correction using ETDRS (Early Treatment of Diabetic Retinopathy Study) charts positioned at a consistent, manufactured distance. VA was measured in logMAR (logarithm of the minimum angle of resolution), with a lower logMAR value indicating better visual acuity. A responder was defined as a participant who achieved bilateral uncorrected distance visual acuity and bilateral uncorrected near visual acuity of ≤0.1 LogMAR at the Month 6 visit.|Month 6 after second eye implantation|This analysis population includes all randomized participants to whom the randomized IOL was presented and/or implanted during the first eye surgery (from a try to a full success), as randomized. Last observation carried forward (LOCF) was used for missing data.||percentage of participants|||Number
836661|NCT01290094|Secondary|Correlation Coefficient of Participant's Profile With Compliance|Participant's profile included age, year since menopause, fracture history, and BMD at baseline.|Baseline up to Month 12|ITT population.||correlation coefficient|||Number
836662|NCT01290094|Secondary|Percentage of Participants Who Received All Planned Study Medication (Compliance)||Baseline up to Month 12|ITT population.||percentage of participants|||Number
836682|NCT01296360|Primary|SCRs (Seroconversion Rate) as Defined by Percentage of Subjects With Plaque Reduction Neutralization Test Titers of>1:10 at 1 Month After the Booster Dose||1 month post booster|Intent-to-treat Population: primary analysis population for the immunogenicity analyses; defined as all subjects randomized||percentage of subjects||95% Confidence Interval|Number
836683|NCT01296412|Secondary|Percentage of Participants Reaching A1C Goal of <6.5%||Week 26|Per-protocol population defined as participants who had a measurement at baseline and a measurement after at least 24 weeks (i.e., 168 days) of treatment, and did not have any major protocol violations.||percentage of participants|||Number
836663|NCT01290094|Secondary|Percent Change From Baseline in Total Hip T-score at Month 12 and 24|"Percent change was calculated as [(measure at time t - measure at baseline)/measure at baseline]*100, where t=12 and 24 months. The baseline value is used as a reference to calculate the relative change from baseline. T-score is the number of standard deviations above or below the mean for a healthy 30 year old adult of the same sex and ethnicity as the participant. A T-score with above -1 is normal bone density level. A T-score between -1 and -2.5 means that the bone density is below normal and it might be a sign of an osteopenia and may also lead into osteoporosis. A T-score below -2.5 indicates osteoporosis. A T-score below -2.5 in combination with a prevalent fracture indicates serious osteoporosis."|Baseline, Month 12, Month 24|ITT population. Here “n” included participants who were evaluable at specified time point for the given arm.||percent change||Standard Deviation|Mean
836664|NCT01290094|Secondary|Percent Change From Baseline in Lumbar Spine T-score at Month 12 and 24|"Percent change was calculated as [(measure at time t - measure at baseline)/measure at baseline]*100, where t=12 and 24 months. The baseline value is used as a reference to calculate the relative change from baseline. T-score is the number of standard deviations above or below the mean for a healthy 30 year old adult of the same sex and ethnicity as the participant. A T-score with above -1 is normal bone density level. A T-score between -1 and -2.5 means that the bone density is below normal and it might be a sign of an osteopenia and may also lead into osteoporosis. A T-score below -2.5 indicates osteoporosis. A T-score below -2.5 in combination with a prevalent fracture indicates serious osteoporosis."|Baseline, Month 12, Month 24|ITT population. Here “n” included participants who were evaluable at specified time point for the given arm.||percent change||Standard Deviation|Mean
836665|NCT01290094|Primary|Percent Change From Baseline in Mean Hip BMD at Month 24|"Percent change was calculated as [(measure at time t - measure at baseline)/measure at baseline]*100, where t=24 months. The baseline value is used as a reference to calculate the relative change from baseline."|Baseline, Month 24|ITT population. Here “number of participants analyzed” included participants who were evaluable for this outcome measure.||percent change||Standard Deviation|Mean
836666|NCT01290094|Primary|Percent Change From Baseline in Mean Hip Bone BMD at Month 12|"Percent change was calculated as [(measure at time t - measure at baseline)/measure at baseline]*100, where t=12 months. The baseline value is used as a reference to calculate the relative change from baseline."|Baseline, Month 12|ITT population.||percent change||Standard Deviation|Mean
836667|NCT01290094|Primary|Percent Change From Baseline in Mean Lumbar Spine BMD at Month 24|"Percent change was calculated as [(measure at time t - measure at baseline)/measure at baseline]*100, where t=24 months. The baseline value is used as a reference to calculate the relative change from baseline."|Baseline, Month 24|ITT population. Here “number of participants analyzed” included participants who were evaluable for this outcome measure.||percent change||Standard Deviation|Mean
836668|NCT01290094|Primary|Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at Month 12|"Percent change was calculated as [(measure at time t minus [-] measure at baseline) divided by (/) measure at baseline] multiplied by (*) 100, where t=12 months. The baseline value is used as a reference to calculate the relative change from baseline."|Baseline, Month 12|ITT population.||percent change||Standard Deviation|Mean
836669|NCT01296347|Secondary|Incidence of Pain|"Measures in pain include:
Numeric pain score of 0 to 10. Zero denotes 'no pain'; 10 denotes 'pain as bad as you can imagine' Brief Pain Inventory (BPI) Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS)"|3, 6 and 12 months||||||
836670|NCT01296347|Secondary|Incidence of Side-effects|The presence of nausea, vomiting, itching, sedation, feeling lightheaded or vivid dreams will be recorded at the above time points|24 hours, 48 hours||||||
836671|NCT01296347|Secondary|Sensory Testing|"Hypoaesthesia: light touch of the blunt end of a paintbrush was felt less precisely, than in healthy tissue.
Hyperalgesia: the pain induced by a sterile neurotip, applied perpendicular to the skin is felt abnormally strongly, in comparison to the contralateral side.
Static allodynia: the application of a Von Frey hair number 14. (8g) was unpleasant, in comparison to the contralateral side.
Dynamic allodynia: three successive gentle strokes of an 8 mm-wide paintbrush over a 40 mm distance, is unpleasant, in comparison to the contralateral side."|6 weeks, 6 months, 12 months||||||
836672|NCT01296347|Secondary|Analgesic Consumption|Analgesia consumption will be measured post-operatively and at the time points stated above. The cumulative dose of opioid, measured in oral morphine equivalents, will be obtained from the time of the patient’s arrival in recovery (T0), to 24 hours post-operatively (T0 + 24) and to 48 hours post-operatively (T0 + 48). Analgesia consumption will also be measured at six weeks, three months, six months and one year. All analgesia will be converted to oral morphine equivalents (in mg) by multiplication by a factor depending on the analgesia taken (codeine 0.15, tramadol 0.17, oxycodone 2)|24 hours, 48 hours, 6 weeks, 3, 6 and 12 months||||||
836673|NCT01296347|Primary|The Incidence of Pain|"Measures in pain include:
Numeric pain score of 0 to 10. Zero denotes 'no pain'; 10 denotes 'pain as bad as you can imagine'"|6 weeks after surgery|||units on a scale||Standard Deviation|Mean
836674|NCT01296360|Secondary|Rate of Subjects With Solicited AEs for up to 7 Days Following the Booster Dose. Severity and Duration.||7 days||||||
836675|NCT01296360|Secondary|Rate of Subjects With Unsolicited AEs Within 1 Month Following the Booster Dose. Severity, Duration and Relationship to Vaccinations.||1 month||||||
836676|NCT01296360|Secondary|Rate of Subjects With SAEs and Medically Attended AEs Within 1 Month Following the Booster Dose. Severity, Duration and Relationship to Vaccinations.||1 month||||||
836677|NCT01296360|Secondary|Rate of Subjects With Unsolicited AEs (Adverse Events) up to Months 12, 24 and 36 After the First IXIARO Vaccination in IC51 323 With and Without Booster Vaccination. Severity, Duration and Relationship to Vaccinations.||36 months||||||
836678|NCT01296360|Secondary|Rate of Subjects With SAEs (Serious Adverse Events) Following Immunization and Medically Attended AEs (Adverse Events) up to Months 12, 24 and 36 After the First IXIARO Vaccination in IC51 323 With and Without Booster Vaccination. Severity, Duration and||36 months||||||
836679|NCT01296360|Secondary|GMTs and Rate of Subjects With a PRNT Titer of >1:10 at Months 12, 24 and 36 After First IXIARO Vaccination in IC51-323 With and Without Booster Vaccination||36 months||||||
836680|NCT01296360|Secondary|GMTs (Geometric Mean Titre) for JEV Neutralizing Antibodies Measured Using a Validated PRNT (Plaque Reduction Neutralization Test) at 1 Month After the Booster Dose||1 month||||||
836681|NCT01296360|Secondary|Rate of Subjects Achieving a >4-fold Increase in JEV (Japanese Encephalitis Virus) Neutralizing Antibody Titers at 1 Month After the Booster Dose||1 month||||||
836685|NCT01296412|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|Change from baseline at Week 26 is defined as Week 26 minus Week 0.|Baseline and Week 26|Per-protocol population defined as participants who had a measurement at baseline and a measurement after at least 24 weeks (i.e., 168 days) of treatment, and did not have any major protocol violations.||mg/dL||95% Confidence Interval|Least Squares Mean
836686|NCT01296412|Primary|Change From Baseline in Hemoglobin A1c (A1C)|A1C is measured as percent. Thus, this change from baseline reflects the Week 26 A1C percent minus the Week 0 A1C percent.|Baseline and Week 26|Per-protocol population defined as participants who had a measurement at baseline and a measurement after at least 24 weeks (i.e., 168 days) of treatment, and did not have any major protocol violations.||percent||95% Confidence Interval|Least Squares Mean
836687|NCT01299571|Secondary|Number of Participants With the Indicated Unexpected Adverse Events|An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Unexpected adverse events include those not listed in the approved product information and not described as precautions or warnings.|6 months|ITT Population||participants|||Number
836688|NCT01299571|Secondary|Number of Participants With a Serious Adverse Event|"A serious adverse event is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or results in prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. For a list of all serious adverse events occurring during the course of the study, see the table entitled Serious Adverse Events in the Adverse Event section of the results record."|6 months|ITT Population||participants|||Number
836689|NCT01299571|Primary|Number of Participants With an Adverse Event|"An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. For a list of all adverse events occurring during the course of the study, see the table entitled Other (Non-Serious) Adverse Events in the Adverse Event section of the results record."|6 months|Intent-to-Treat (ITT) Population: all participants who had been administered the investigational drug at least once and had completed all safety assessments||participants|||Number
836690|NCT01299584|Secondary|Number of Participants With the Indicated Unexpected Adverse Event|An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Unexpected adverse events include those not listed in the approval product information and not described as precautions or warnings.|24 hours|ITT Population||participants|||Number
836691|NCT01299584|Secondary|Number of Participants With a Serious Adverse Event|"A serious adverse event is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or results in prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. For a list of all SAEs occurring during the course of the study, see the table entitled Serious Adverse Events in the Adverse Event section of the results record."|24 hours|ITT Population||participants|||Number
836692|NCT01299584|Secondary|Number of Participants With an Adverse Event|"An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. For a list of all AEs occurring during the course of the study, see the table entitled Other (Non-Serious) Adverse Events in the Adverse Event section of the results record."|24 hours|ITT Population||participants|||Number
836693|NCT01299584|Primary|Number of Participants With an Unexpected Serious Adverse Event|A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening requires hospitalization or results in prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. An unexpected event is an event that is not listed in the approval product information and is not described as a precaution or warning.|24 hours|Intent-to-Treat (ITT) Population: all participants who had been administered the investigational drug at least once and had undergone all safety assessments||participants|||Number
836694|NCT01299805|Primary|Time to Maximum Concentration of 5-HIAA in Cerebrospinal Fluid|The time to reach maximum pharmacodynamic effect (Emax) was assessed by the time to maximum concentration of 5-hydroxyindoleacetic acid (5-HIAA) in cerebrospinal fluid (CSF) at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).|Day -1, Day 1 and Day 14. CSF samples were taken prior to dose and at 1, 2, 4, 8, 12, 16, and 24 hours postdose.|"The pharmacodynamic (PD) set consisted of all participants in the safety set with sufficient plasma or serum or CSF data for derivation of at least 1 PD parameter. If a patient's concentration profile contained ≤3 data points, the PD parameter results were not included. n indicates the number of patients with available data at each time point."||hours||Standard Deviation|Mean
836695|NCT01299805|Primary|Maximum Concentration of 5-HIAA in Cerebrospinal Fluid|The maximum observed effect (Emax), assessed by the maximum observed concentration of 5-HIAA in cerebrospinal fluid (CSF) measured at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).|Day -1 (Baseline), Day 1 and Day 14. CSF samples were taken prior to dose and at 1, 2, 4, 8, 12, 16, and 24 hours postdose.|"The pharmacodynamic (PD) set consisted of all participants in the safety set with sufficient plasma or serum or CSF data for derivation of at least 1 PD parameter. If a patient's concentration profile contained ≤3 data points, the PD parameter results were not included. n indicates the number of patients with available data at each time point."||ng/mL||Standard Deviation|Mean
836696|NCT01299805|Primary|Area Under the Effect Curve From Time Zero to 24 Hours Postdose of 5-HIAA in Cerebrospinal Fluid|The area under the effect-time curve from time 0 to 24 hours postdose (AUEC[0-24]) of 5-hydroxyindoleacetic acid (5-HIAA) in cerebrospinal fluid (CSF) was measured at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).|Day -1 (Baseline), Day 1 and Day 14. CSF samples were taken prior to dose and at 1, 2, 4, 8, 12, 16, and 24 hours postdose.|"The pharmacodynamic (PD) set consisted of all participants in the safety set with sufficient plasma or serum or CSF data for derivation of at least 1 PD parameter. If a patient's concentration profile contained ≤3 data points, the PD parameter results were not included. n indicates the number of patients with available data at each time point."||ng*hr/mL||Standard Deviation|Mean
836707|NCT01299909|Primary|Smoking Abstinence|Self-reported 7-day point-prevalence smoking abstinence (i.e., no smoking in the past 7 days) biochemically confirmed by carbon monoxide breath testing in MTS vs ITS subjects at 24 weeks post quit day.|24 weeks post quit day|analysis was conducted on all randomized participants||participants|||Number
836697|NCT01299805|Primary|Time to Maximum Concentration of 5-HIAA in Plasma|The time to reach maximum pharmacodynamic effect (Emax) was assessed by the time to maximum concentration of 5-hydroxyindoleacetic acid (5-HIAA) in plasma after a single dose (Day 1) and after multiple doses (Day 14). Note: Plasma samples for 5-HIAA on Day -1 were lost in shipping. Therefore, no PD parameters were calculated for Day -1.|Day 1 and Day 14. Blood samples were taken predose and at 1, 2, 4, 8, 12, 16 and 24 hours post-dose.|"The pharmacodynamic (PD) set consisted of all participants in the safety set with sufficient plasma or serum or CSF data for derivation of at least 1 PD parameter. If a patient's concentration profile contained ≤3 data points, the PD parameter results were not included. n indicates the number of patients with available data at each time point."||hours||Standard Deviation|Mean
836698|NCT01299805|Primary|Maximum Concentration of 5-HIAA in Plasma|The maximum observed effect (Emax), assessed by the maximum observed concentration of 5-HIAA in plasma measured after a single dose (Day 1) and after multiple doses (Day 14). Note: Plasma samples for 5-HIAA on Day -1 were lost in shipping. Therefore, no PD parameters were calculated for Day -1|Day 1 and Day 14. Blood samples were taken predose (up to 15 minutes prior) and at 1, 2, 4, 8, 12, 16 and 24 hours post-dose.|"The pharmacodynamic (PD) set consisted of all participants in the safety set with sufficient plasma or serum or CSF data for derivation of at least 1 PD parameter. If a patient's concentration profile contained ≤3 data points, the PD parameter results were not included. n indicates the number of patients with available data at each time point."||ng/mL||Standard Deviation|Mean
836699|NCT01299805|Primary|Area Under the Effect Curve From Time Zero to 24 Hours Postdose of 5-hydroxyindoleacetic Acid (5-HIAA) in Plasma|Area under the effect-time curve from time 0 to 24 hours postdose (AUEC[0-24]) of 5-HIAA, a metabolite of the neurotransmitter serotonin, in plasma was measured after a single dose (Day 1) and after multiple doses (Day 14). Note: Plasma samples for 5-HIAA on Day -1 were lost in shipping. Therefore, no PD parameters were calculated for Day -1.|Day 1 and Day 14. Blood samples were taken predose and at 1, 2, 4, 8, 12, 16 and 24 hours post-dose.|"The pharmacodynamic (PD) set consisted of all participants in the safety set with sufficient plasma or serum or CSF data for derivation of at least 1 PD parameter. If a patient's concentration profile contained ≤3 data points, the PD parameter results were not included. n indicates the number of patients with available data at each time point."||ng*hr/mL||Standard Deviation|Mean
836700|NCT01299805|Primary|Time to Maximum Concentration of 5-HT in Cerebrospinal Fluid|The time to reach maximum pharmacodynamic effect (Emax) was assessed by the time to maximum concentration of 5-HT in cerebrospinal fluid (CSF) at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).|Day -1, Day 1 and Day 14. CSF samples were taken predose and at 1, 2, 4, 8, 12, 16, and 24 hours postdose.|"The pharmacodynamic (PD) set consisted of all participants in the safety set with sufficient plasma or serum or CSF data for derivation of at least 1 PD parameter. If a patient's concentration profile contained ≤3 data points, the PD parameter results were not included. n indicates the number of patients with available data at each time point."||hours||Standard Deviation|Mean
836701|NCT01299805|Primary|Maximum Concentration of 5-HT in Cerobrospinal Fluid|The maximum observed effect (Emax), assessed by the maximum concentration of 5-HT in cerebrospinal fluid (CSF) measured at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).|Day -1 (Baseline), Day 1 and Day 14. CSF samples were taken prior to dose and at 1, 2, 4, 8, 12, 16, and 24 hours postdose.|"The pharmacodynamic (PD) set consisted of all participants in the safety set with sufficient plasma or serum or CSF data for derivation of at least 1 PD parameter. If a patient's concentration profile contained ≤3 data points, the PD parameter results were not included. n indicates the number of patients with available data at each time point."||pg/mL||Standard Deviation|Mean
836702|NCT01299805|Primary|Area Under the Effect Curve From Time Zero to 24 Hours Postdose of 5-HT in Cerebrospinal Fluid|The area under the effect-time curve from time 0 to 24 hours postdose (AUEC[0-24]) of 5-hydroxytryptamine (5-HT) in cerebrospinal fluid (CSF) was measured at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).|Day -1 (Baseline), Day 1 and Day 14. CSF samples were taken prior to dose and at 1, 2, 4, 8, 12, 16, and 24 hours postdose.|"The pharmacodynamic (PD) set consisted of all participants in the safety set with sufficient plasma or serum or CSF data for derivation of at least 1 PD parameter. If a patient's concentration profile contained ≤3 data points, the PD parameter results were not included. n indicates the number of patients with available data at each time point."||pg*hr/mL||Standard Deviation|Mean
836703|NCT01299805|Primary|Time to Maximum Concentration of 5-HT in Plasma|The time to reach maximum pharmacodynamic effect (Emax) was assessed by the time to maximum concentration of 5-HT in plasma at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).|Day -1 (Baseline), Day 1 and Day 14. Blood samples were taken predose and at 1, 2, 4, 8, 12, 16, and 24 hours postdose.|"The pharmacodynamic (PD) set consisted of all participants in the safety set with sufficient plasma or serum or CSF data for derivation of at least 1 PD parameter. If a patient's concentration profile contained ≤3 data points, the PD parameter results were not included. n indicates the number of patients with available data at each time point."||hours||Standard Deviation|Mean
836704|NCT01299805|Primary|Maximum Concentration of 5-HT in Plasma|The maximum observed effect (Emax), assessed by the maximum observed concentration of 5-HT in plasma measured at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).|Day -1 (Baseline), Day 1 and Day 14. Blood samples were taken predose (up to 15 minutes prior) and at 1, 2, 4, 8, 12, 16 and 24 hours post-dose.|"The pharmacodynamic (PD) set consisted of all participants in the safety set with sufficient plasma or serum or CSF data for derivation of at least 1 PD parameter. If a patient's concentration profile contained ≤3 data points, the PD parameter results were not included. n indicates the number of patients with available data at each time point."||pg/mL||Standard Deviation|Mean
836705|NCT01299805|Primary|Area Under the Effect Curve From Time Zero to 24 Hours Postdose of 5-hydroxytryptamine (5-HT) in Plasma|The area under the effect-time curve from time 0 to 24 hours postdose (AUEC[0-24]) of the neurotransmitter 5-HT (serotonin) in plasma was measured at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).|Day -1 (Baseline), Day 1 and Day 14. Blood samples were taken predose (up to 15 minutes prior) and at 1, 2, 4, 8, 12, 16 and 24 hours post-dose.|"The pharmacodynamic (PD) set consisted of all participants in the safety set with sufficient plasma or serum or CSF data for derivation of at least 1 PD parameter. If a patient's concentration profile contained ≤3 data points, the PD parameter results were not included. n indicates the number of patients with available data at each time point."||pg*hr/mL||Standard Deviation|Mean
836710|NCT01299961|Primary|12 Month Change in 7-Joint Ultrasound (US) Inflammatory Score|The 7-joint US inflammatory score includes the addition of synovial hypertrophy scores and power doppler scores.|baseline, 12 months|Total of 19 patients completed 12 mos||units on a scale||Standard Deviation|Mean
836711|NCT01300052|Secondary|Number of Participants With Local Tolerability Symptoms: Pruritus|Local tolerability was evaluated in participants in terms of presence and absence of pruritus symptom and its severity in the areas of body where medication was applied. Pruritus symptoms were graded on a 4-point scale of 0 - 3 where 0 =none (no pruritus), 1 =mild (occasional, slight itching/scratching), 2 = moderate (constant or intermittent itching/scratching which was not disturbing sleep), 3 = severe (bothersome itching/scratching which was disturbing sleep). Higher scores=Severe symptoms. In this outcome measure, number of participants with none, mild, moderate and severe pruritus symptoms were reported.|Baseline (Day 1) up to Day 84|Safety population included all randomized participants with confirmed usage of the study medication. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||participants|||Number
836712|NCT01300052|Secondary|Number of Participants With Local Tolerability Symptoms: Burning/Stinging|Local tolerability in participants was evaluated in terms of presence and absence of burning/stinging symptom and its severity in the areas of body where medication was applied. Burning/stinging symptoms were graded on a 4-point scale of 0 - 3 where 0 =none (no stinging/ burning), 1 =mild (slight warm, tingling sensation), 2 = moderate (definite warm; tingling/stinging sensation), 3 = severe (hot, tingling/stinging sensation that caused definite discomfort). Higher scores=Severe symptoms. In this outcome measure, number of participants with none, mild, moderate and severe burning/stinging symptoms were reported.|Baseline (Day 1) up to Day 84|Safety population included all randomized participants with confirmed usage of the study medication. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||participants|||Number
836713|NCT01300052|Secondary|Number of Treatment-Emergent Adverse Events (TEAEs) by Severity|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs were classified according to the severity in 3 categories a) mild =AEs does not interfere with participant’s usual function b) moderate =AEs interfered to some extent with participant’s usual function c) severe =AEs interfered significantly with participant’s usual function and required systemic drug therapy. Treatment-emergent were events between first dose of study drug and up to Day 84 that were absent before treatment or that worsened relative to pretreatment state. In this outcome measure, number of mild, moderate and severe TEAEs were reported.|Baseline (Day 1) up to Day 84|Safety population included all randomized participants with confirmed usage of the study medication.||adverse events|||Number
836714|NCT01300052|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Day 84 that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAE and non-SAE.|Baseline (Day 1) up to Day 84|Safety population included all randomized participants with confirmed usage of the study medication.||participants|||Number
836715|NCT01300052|Secondary|Change From Baseline in Percentage of Body Surface Area (%BSA) Involved With Psoriasis at Day 84|Percentage of the total body surface area (BSA) involved with psoriasis was measured. Change from Baseline (Day 1) in percentage of BSA at Day 84 was reported.|Baseline (Day 1), Day 84|ITT population included all randomized participants who received the study medication. Missing data was imputed using LOCF method.||percentage of body surface area||Standard Deviation|Mean
836716|NCT01300052|Secondary|Percentage of Participants Who Achieved Success in Physician's Global Assessment (PGA) of Disease Severity at Days 14, 28, 42, 56, and 70|PGA assessed severity of overall disease activity in participants. It was performed using a 6-point scale graded from 0 - 5, in which 0 = clear (no plaque elevation above normal skin level), 1 = almost clear (essentially flat with possible trace elevation), 2 = mild (slight but definite elevation of plaque above normal skin level), 3 = moderate (moderate elevation with rounded or sloped edges to plaque), 4 = severe (marked elevation with hard, sharp edges to plaque), 5 = very severe (very marked elevation with very hard, sharp edges to plaque). The success in PGA of disease severity was defined as a PGA score of ‘0 = clear’ or ‘1 = almost clear’, with at least 2-grade improvement in PGA from Baseline to Day 14, 28, 42, 56 and 70.|Day 14, Day 28, Day 42, Day 56, Day 70|ITT population included all randomized participants who received the study medication.||percentage of participants||95% Confidence Interval|Number
836717|NCT01300052|Primary|Percentage of Participants Who Achieved Success in Physician's Global Assessment (PGA) of Disease Severity at Day 84|PGA assessed severity of overall disease activity in participants. It was performed using a 6-point scale graded from 0 - 5, in which 0 = clear (no plaque elevation above normal skin level), 1 = almost clear (essentially flat with possible trace elevation), 2 = mild (slight but definite elevation of plaque above normal skin level), 3 = moderate (moderate elevation with rounded or sloped edges to plaque), 4 = severe (marked elevation with hard, sharp edges to plaque), 5 = very severe (very marked elevation with very hard, sharp edges to plaque). The success in PGA of disease severity was defined as a PGA score of ‘0 = clear’ or ‘1 = almost clear’, with at least 2-grade improvement in PGA from Baseline to Day 84.|Day 84|ITT population included all randomized participants who received the study medication. Missing data was imputed using last observation carried forward (LOCF) method.||percentage of participants||95% Confidence Interval|Number
836718|NCT01300234|Secondary|Number of Participants in the Indicated Category for Hepatic Laboratory Abnormalities|"The Gilead Grading Scale for Severity of Adverse Events and Laboratory Abnormalities, version 21, September 2011 was used for grading. Confirmed is defined as two consecutive visits. mg=milligrams. dL=deciliter."|Baseline; up to Week 48/Early Withdrawal|Safety Analysis Population||participants|||Number
836774|NCT01300546|Secondary|Doses of Study Medication|Total number of doses of study medication reported taken per participant in Treatment Period Months 1, 2, and 3 in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm.|Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.|||doses of study medication||Standard Deviation|Mean
836719|NCT01300234|Secondary|Number of Participants With the Indicated Treatment-emergent Laboratory Abnormalities for Serum Creatinine and Serum Phosphorus|The Gilead Grading Scale for Severity of Adverse Events and Laboratory Abnormalities, version 21, September 2011 was used for grading. Serum creatinine: Grade 1, >=133 to 177 micromoles per Liter (µmoles/Liter), Grade 2, >177 to 265 µmoles/Liter, Grade 3, >265 to 530 µmoles/Liter, Grade 4, >530 µmoles/Liter. Serum phosphorus: Grade 2, 0.63 to <0.80 millimoles per Liter (mmoles/L), Grade 3, 0.31 to <0.63 mmoles/L, Grade 4, <0.31 mmoles/L. The normal range for serum phosphorus was 0.8 to 1.45 mmol/L; the upper limit for a Grade 2 abnormality is 0.80 mmol/L. Therefore, no Grade 1 abnormalities could be attributed, as values were contained within the normal range.|up to Week 48/Early Withdrawal|Safety Analysis Population||participants|||Number
836720|NCT01300234|Secondary|Number of Participants With the Indicated Grade 3 and Grade 4 Treatment-emergent (TE) Laboratory Abnormalities (LAs)|TE grade 3 or grade 4 LAs are defined as values that increase by >=1 grade from Baseline (Day 0) to Grade 3 (severe) or 4 (potentially life threatening) at any post-Baseline value. The Gilead Grading Scale for Severity of Adverse Events and Laboratory Abnormalities, version 21, September 2011 was used for grading. Sodium: hyponatremia, Grade (G) 3=121-<125 millimoles per Liter (mmol/L), G4=<121 mmol/L; hypernatremia, G3=>154-159 mmol/L, G4=>159 mmol/L. Phosphate: hypokalemia, G3=2.0-<2.5 mmol/L, G4=<2,0 mmol/L; hyperkalemia, G3=>6.5-7 mmol/L, G4=>7.0 mmol/L. Alanine aminotransferase/aspartate aminotransferase: G3=>5.00-10.00 × upper limit of normal (ULN), G4=>10.0 × ULN. Bilirubin: G3=>2.5-5.0 × ULN, G4=>5.0 × ULN. Creatinine kinase: G3=10.0-<20.0 × ULN, G4=>=2.0 × ULN. Hemoglobin: 70-<90 grams per Liter (g/L), G4=<70 g/L. Platelets: G3=25-<50 GI (10^9)/L, G4=<25 GI/L. Neutrophils: G3, 0.50-<0.75 GI/L, G4=<0.50 GI/L. Prothrombin time: G3=>1.50-3.00 × ULN, G4=>3.00 × ULN.|Baseline; up to Week 48/Early Withdrawal|Safety Analysis Population||participants|||Number
836721|NCT01300234|Secondary|Number of Participants With Any Serious Adverse Event (SAE) and Any Adverse Event (AE)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is Grade 4 (life threatening or disabling). Refer to the general AE/SAE module for a complete list of AEs and SAEs.|up to Week 48|Safety Analysis Population: all participants who received at least one dose of study medication and had at least one post-Baseline safety assessment||participants|||Number
836722|NCT01300234|Secondary|Number of Participants With Virological Breakthrough at Week 48|The number of HBeAg-positive and HBeAg-negative participants who had virological breakthrough at Week 48 was assessed. Virological breakthrough is defined as an HBV DNA increase of >=1 log10 copies/mL above the treatment nadir, confirmed on two consecutive visits.|Week 48|ITT Population. Only those participants available at the indicated time points were assessed.||participants|||Number
836723|NCT01300234|Secondary|Number of Participants Achieving Durable HBsAg Loss From Weeks 24 to Week 48|Durable HBsAg loss is defined as the loss of HBsAg and no detectable HBV DNA and ALT normalization at any three consecutive visits at least 12 weeks apart. This report includes data up to and including Week 48. Long-term efficacy data (up to Week 240) will eventually be reported.|Week 24 to Week 48|ITT Population. Only those participants available at the indicated time points were assessed. A non-completers equal failures approach was used for analysis. A non-completers equal failures approach was used for analysis.||participants|||Number
836724|NCT01300234|Secondary|Number of HBeAg-negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Weeks 24 and 48|HBsAg loss is defined as a negative HBsAg result for those participants with who were HBsAg positive at Baseline. Seroconversion to anti-HBs is defined as HBsAg loss and a positive anti-HBs result. This report includes data up to and including Week 48. Long-term efficacy data (up to Week 240) will eventually be reported.|Weeks 24 and 48|ITT Population. Only those participants available at the indicated time points were assessed. A non-completers equal failures approach was used for analysis.||participants|||Number
836725|NCT01300234|Secondary|Number of HBeAg-positive Participants Achieving HBsAg Loss and HBsAg Seroconversion at Weeks 24 and 48|Hepatitis B surface Antigen (HBsAg) loss is defined as negative HBsAg results for those participants with who were HBsAg positive at Baseline. Seroconversion to anti-HBs is defined as HBsAg loss and a positive anti-HBs result. This report includes data up to and including Week 48. Long-term efficacy data (up to Week 240) will eventually be reported.|Weeks 24 and 48|ITT Population. Only those participants available at the indicated time points were assessed. A non-completers equal failures approach was used for analysis.||participants|||Number
836726|NCT01300234|Secondary|Number of HBeAg-positive Participants Achieving HBeAg Loss and HBeAg Seroconversion at Weeks 24 and 48|HBeAg loss is defined as a negative HBeAg result for those participants who were HBeAg positive at Baseline. Seroconversion to anti-HBe is defined as HBeAg loss and a positive anti-HBe result. This report includes data up to and including Week 48. Long-term efficacy data (up to Week 240) will eventually be reported.|Week 24 and 28|ITT Population. Only those participants available at the indicated time points were assessed. A non-completers equal failures approach was used for analysis.||participants|||Number
836736|NCT01300247|Secondary|Duration of Objective Response (DOR), Assessed by the Investigator According to IWCLL Guidelines|DOR for participants with OR: time from first CR, CRi or PR to disease progression (DP), relapse, or death, assessed by the investigator. DP: >=50% increase in lymphocytes to at least 5x10^9/L;new palpable lymph nodes (>15 millimeters [mm] in longest diameter) or any new extra-nodal lesion; >=50% increase in the longest diameter of any previous site of lymphadenopathy; >=50% increase in the enlargement of the liver and/or spleen; transformation to a more aggressive histology. CR:peripheral blood lymphocytes (PBL) <4x10^9/L; no lymphadenopathy; no hepatomegaly or splenomegaly (below relevant costal margin); no symptoms; bone marrow at least normocellular for age, with <30% of nucleated cells being lymphocytes. PR: >=50% decrease in PBL, >=50% reduction in lymphadenopathy, >=50% reduction of liver and/or spleen enlargement, either neutrophil, platelet, or hemoglobin (Hb) recovery. CRi: met CR criteria, lymphocyte infiltration <30%; may not meet Hb, platelet or neutrophil count recovery.|From first documented objective response up to disease progression or relapse or death, whichever occurred first (up to approximately 6 months)|Safety evaluable population.||percentage of participants||95% Confidence Interval|Number
836727|NCT01300234|Secondary|Number of Participants With Histological Improvement at Week 48 Who Had a Baseline Knodell Necroinflammatory Score (KNS) >=2|Histological improvement is defined as a reduction of >=2 points in the KNS with no increase in fibrosis at Week 48 in participants with a Baseline KNS >=2, which was derived from the American Association for the Study of Liver Diseases Practice Guidelines for Management of Chronic Hepatitis B (2009) and the European Association for the Study of the Liver Clinical Practice Guidelines Management of chronic hepatitis B virus infection (2012). The Knodell scale consists of 5 domains: periportal+/-bridging necrosis (scored as 0 [best], 1, 3, 4, 5, 6, or 10 [worst]); and intralobular degeneration/focal necrosis, portal inflammation, and fibrosis (all scored as 0-4). The necroinflammatory score (0 [best] to 14 [worst]) is the combined score for necrosis (0-10) plus inflammation (0-4; the participant is scored for only one inflammatory condition). Liver biopsy was done at selected sites. Liver biopsy slides within 6 months prior to randomization could be accepted as the Baseline evaluation.|Baseline and Week 48|"ITT Population. Only those participants who had a Baseline Knodell necroinflammatory score >=2 were included in this analysis. The ns in the category titles represent the number of HBeAg-positive and HBeAg-negative participants. At least 60 participants in each treatment arm were planned to undergo liver biopsy."||participants|||Number
836728|NCT01300234|Secondary|Number of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48 in Participants Who Had Abnormal ALT at Baseline|Participants who had abnormal ALT at Baseline and had normalized ALT at Week 48 were assessed. This report includes data up to and including Week 48. Long-term efficacy data (up to Week 240) will eventually be reported. An increased level of ALT is referred to as abnormal ALT (the normal range is 0 to 48 units per liter [U/L]). Week 96, 144, 192, and 240 data are not yet available, as this report includes data up to and including Week 48.|Baseline and Week 48|"ITT Population. Only those participants who had abnormal ALT at Baseline were included in this analysis. The ns in the category titles represent the number of HBeAg-positive and HBeAg-negative participants."||participants|||Number
836729|NCT01300234|Secondary|Log 10 Copies/mL Reduction From Baseline HBV DNA at Week 48|The log 10 copies/mL reduction from Baseline HBV DNA at Week 48 in the HBeAg-positive and HBeAg-negative population was assessed. This report includes data up to and including Week 48. Long-term efficacy data (up to Week 240) will eventually be reported. HBeAg is a viral protein that is secreted by hepatitis B-infected cells. It is associated with chronic hepatitis B infections and is used as a marker of active viral disease and a participant's degree of infectiousness. A positive result indicates that the participant has high levels of virus in the blood and greater infectiousness. Usually, a negative result indicates that the participant has lower levels of virus in the blood and is less infectious. Week 96, 144, 192, and 240 data are not yet available, as this report includes data up to and including Week 48.|Baseline and Week 48|"ITT Population. Only those participants available at the indicated time point were assessed. The ns in the category titles represent the number of HBeAg-positive and HBeAg-negative participants."||log 10 copies/mL||Standard Deviation|Mean
836730|NCT01300234|Secondary|Participants With HBV DNA <400 Copies/mL at Weeks 96, 144, 192, and 240|The number of participants with HBV DNA <400 copies/mL in the hepatitis B e antigen (HBeAg)-positive and HBeAg-negative population was assessed. HBeAg is a viral protein that is secreted by hepatitis B-infected cells. It is associated with chronic hepatitis B infections and is used as a marker of active viral disease and a participant's degree of infectiousness. A positive result indicates that the participant has high levels of virus in the blood and greater infectiousness. Usually, a negative result indicates that the participant has lower levels of virus in the blood and is less infectious. Week 96, 144, 192, and 240 data are not yet available, as this report includes data up to and including Week 48.|Weeks 96, 144, 192, and 240||12/2017||||
836731|NCT01300234|Primary|Participants With Hepatitis B Virus (HBV) DNA <400 Copies/Milliliter (mL) at Week 48|The number of participants with Hepatitis B Virus (HBV) deoxyribonucleic acid (DNA) <400 copies/milliliter (mL) at Week 48 in the hepatitis B e antigen (HBeAg)-positive and HBeAg-negative population was assessed. HBeAg is a viral protein that is secreted by hepatitis B-infected cells. It is associated with chronic hepatitis B infections and is used as a marker of active viral disease and a participant's degree of infectiousness. A positive result indicates that the participant has high levels of virus in the blood and greater infectiousness. Usually, a negative result indicates that the participant has lower levels of virus in the blood and is less infectious.|Week 48|"Intent-to-Treat (ITT) Population: all randomized participants (par.) who received at least one dose of study medication. Only those par. available at the indicated time point were assessed. The ns in the category titles represent the number of HBeAg-positive and HBeAg-negative par. A non-completers equal failures approach was used for analysis."||participants|||Number
836732|NCT01300247|Secondary|Percentage of Participants Who Had B-Cell Recovery|B-cell recovery was defined as CD19 >=0.07×10^9/L, where participants’ CD19 were previously depleted. B-cell recovery was only considered possible when the participant had received the last dose of study treatment.|Follow-up at 6 months, 6-12 months and after 12 months up to end of study (up to approximately 4 years)|Safety evaluable population||percentage of participants|||Number
836733|NCT01300247|Secondary|Percentage of Participants Who Had B-Cell Depletion|B-cell depletion was defined as cluster of differentiation 19 (CD19) <0.07×10^9/L and could occur only after at least one dose of study drug had been administered.|Up to the end of the treatment period, and follow-up at 6 months, 6-12 months and after 12 months up to end of study (up to approximately 4 years)|Safety evaluable population||percentage of participants|||Number
836734|NCT01300247|Secondary|Percentage of Participants Who Were Alive||Baseline up to relapse or progression or death from any cause, whichever occurred first, up to end of study (up to approximately 4 years)|Safety evaluable population.||percentage of participants|||Number
836735|NCT01300247|Secondary|Percentage of Participants Who Were Alive and Progression Free|Progressive disease assessed using IWCLL: >=50% increase in the absolute number of circulating lymphocytes to at least 5x10^9/L; Appearance of new palpable lymph nodes (>15 millimeters [mm] in longest diameter) or any new extra-nodal lesion; >=50% increase in the longest diameter of any previous site of lymphadenopathy; >=50% increase in the enlargement of the liver and/or spleen; transformation to a more aggressive histology.|Baseline up to relapse or progression or death from any cause, whichever occurred first, up to end of study (up to approximately 4 years)|Safety evaluable population.||percentage of participants|||Number
836789|NCT01300624|Primary|Trained Sentence Probe|Picture description task that include trained words.|pre-treatment, post-treatment and 3-months post-treatment (maintenance)|||percentage of correct sentences||Standard Deviation|Mean
836737|NCT01300247|Secondary|Percentage of Participants With Objective Response, Assessed According to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Guidelines|Objective response was defined as a complete response (CR), CR with incomplete marrow recovery (CRi) or partial response (PR), as determined by investigator. CR:required peripheral blood lymphocytes <4x10^9/L; absence of lymphadenopathy; no hepatomegaly or splenomegaly by physical examination as determined by measurement below relevant costal margin; absence of disease/constitutional symptoms; bone marrow at least normocellular for age, with <30% of nucleated cells being lymphocytes. PR:Greater than equal to (>=) 50% decrease in peripheral blood lymphocyte count, >=50% reduction in lymphadenopathy, >=50% reduction of liver and/or spleen enlargement, either neutrophil, platelet, or hemoglobin (Hb) recovery. CRi:met all CR criteria including confirmed lymphocyte infiltration <30%; may not meet Hb, platelet or neutrophil count recovery. The 95% confidence interval (CI) was estimated by Clopper-Pearson method. The end of treatment response visit occurred 2-3 months after end of treatment.|Baseline up to relapse or progression or death from any cause, whichever occurred first up to end of treatment response visit (up to approximately 9 months)|Safety evaluable population||percentage of participants||95% Confidence Interval|Number
836738|NCT01300247|Secondary|Half-Life of Obinutuzumab|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Pre-dose on Cycle (C) 1 Day (D) 1, immediately after end of infusion (0.5 hour), 0.5 hour of split dose of C1D2, pre-dose and immediately after end of infusion on C1D3, 8, 15, C2D1, C4D1, C6D1 and at progression (up to 1.75 year overall)|The PK variables could not be calculated as the PK samples were not collected accurately.|||||
836739|NCT01300247|Secondary|Volume of Distribution of Obinutuzumab|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|Pre-dose on Cycle (C) 1 Day (D) 1, immediately after end of infusion (0.5 hour), 0.5 hour of split dose of C1D2, pre-dose and immediately after end of infusion on C1D3, 8, 15, C2D1, C4D1, C6D1 and at progression (up to 1.75 year overall)|The PK variables could not be calculated as the PK samples were not collected accurately.|||||
836740|NCT01300247|Secondary|Clearance of Obinutuzumab|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Pre-dose on C1D1, immediately after end of infusion (0.5 hour), 0.5 hour of split dose of C1D2, pre-dose and immediately after end of infusion on C1D3, 8, 15, C2D1, C4D1, C6D1 and at progression (up to 1.75 year overall)|The PK variables could not be calculated as the PK samples were not collected accurately.|||||
836741|NCT01300247|Secondary|Trough Plasma Concentration (Ctrough) of Obinutuzumab||Pre-dose on C1D1, C1D3, 8, 15, C2D1, C4D1, C6D1|The PK variables could not be calculated as the PK samples were not collected accurately.|||||
836742|NCT01300247|Secondary|Maximum Plasma Concentration (Cmax) of Obinutuzumab||Pre-dose on Cycle (C) 1 Day (D) 1, immediately after end of infusion (0.5 hour), 0.5 hour of split dose of C1D2, pre-dose and immediately after end of infusion on C1D3, 8, 15, C2D1, C4D1, C6D1 and at progression (up to 1.75 year overall)|The PK variables could not be calculated as the PK samples were not collected accurately.|||||
836743|NCT01300247|Secondary|Area Under the Plasma Concentration-Time Curve (AUC) of Obinutuzumab|AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.|Pre-dose on Cycle (C) 1 Day (D) 1, immediately after end of infusion (0.5 hour), 0.5 hour of split dose of C1D2, pre-dose and immediately after end of infusion on C1D3, 8, 15, C2D1, C4D1, C6D1 and at progression (up to 1.75 year overall)|The pharmacokinetic (PK) variables could not be calculated as the PK samples were not collected accurately.|||||
836744|NCT01300247|Primary|Number of Participants With Human Anti-Human Antibodies (HAHAs)||Cycle 1 Day 1 (cycle length = 28 days) up to clinical data cutoff date 24 January 2013 (up to approximately 1.75 years)|Safety evaluable population||participants|||Number
836745|NCT01300260|Other Pre-specified|Area Under the Insulin Concentration-time Curve (AUC)|On Day 1 of each treatment period, all participants (healthy or with type 2 diabetes mellitus [T2DM]) received a single subcutaneous dose of either LY2189265 or placebo. Area under the plasma insulin concentration-time curve from -2 to 20 minutes following the glucagon bolus (INSAUCG) is presented.|After glucagon bolus on Day 3 postdose|All participants (healthy or with type 2 diabetes mellitus [T2DM]) who received at least 1 dose of study drug (LY2189265 or Placebo) with evaluable INSAUCG data.||picomole times hour per liter (pmol*h/L)||95% Confidence Interval|Geometric Mean
836746|NCT01300260|Secondary|Insulin Maximum Concentration (Cmax)|On Day 1 of each treatment period, all participants (healthy or with type 2 diabetes mellitus [T2DM]) received a single subcutaneous dose of either LY2189265 or placebo. Maximum plasma insulin concentration from -2 to 20 minutes following the glucagon bolus (INSCmaxG) is presented.|After glucagon bolus on Day 3 postdose|All participants (healthy or with type 2 diabetes mellitus [T2DM]) who received at least 1 dose of study drug (LY2189265 or Placebo) with evaluable INSCmaxG data.||picomole per liter (pmol/L)||95% Confidence Interval|Geometric Mean
836747|NCT01300260|Primary|Insulin Area Under the Curve (AUC) - Second Phase Response|On Day 1 of each treatment period, all participants (healthy or with type 2 diabetes mellitus [T2DM]) received a single subcutaneous dose of either LY2189265 or placebo. On Day 3 of each treatment period, participants underwent a 6-hour insulin infusion, followed by an intravenous (IV) dextrose 50% bolus to stimulate insulin secretion. Three hours later, participants were administered a second dextrose bolus, followed by an infusion of 20% dextrose and, 15 minutes after the start of the 20% dextrose infusion, a 1-mg glucagon bolus was administered. Area under the plasma insulin concentration time curve from 10 to 180 minutes (INSAUC[10-180]) following the first dextrose bolus (the second phase response) was corrected for baseline, where baseline was the mean of the insulin concentrations obtained between -30 and 0 minutes relative to the first dextrose bolus.|10-180 minutes after dextrose bolus on Day 3 post dose|All participants (healthy and with type 2 diabetes mellitus [T2DM]) who received at least 1 dose of study drug (LY2189265 or Placebo) with evaluable INSAUC(10-180) second response phase data.||picomole times hour per liter (pmol*h/L)||95% Confidence Interval|Geometric Mean
836790|NCT01300650|Secondary|Rate of Adverse Events and Hospitalizations||14 days||||||
836791|NCT01300650|Secondary|Correlation Between Interval Changes in Biomarkers, Peak VO2, and VE/VCO2||14 days||||||
836748|NCT01300260|Primary|Maximum Insulin Concentration (Cmax) - Second Phase Response|On Day 1 of each treatment period, all participants (healthy or with type 2 diabetes mellitus [T2DM]) received a single subcutaneous dose of either LY2189265 or placebo. On Day 3 of each treatment period, participants underwent a 6-hour insulin infusion, followed by an intravenous (IV) dextrose 50% bolus to stimulate insulin secretion. Three hours later, participants were administered a second dextrose bolus, followed by an infusion of 20% dextrose and, 15 minutes after the start of the 20% dextrose infusion, a 1-mg glucagon bolus was administered. Maximum plasma insulin concentration from 10 to 180 minutes (INSCmax[10-180]) following the first dextrose bolus (the second phase response) was corrected for baseline, where baseline was the mean of the insulin concentrations obtained between -30 and 0 minutes relative to the first dextrose bolus.|10-180 minutes after dextrose bolus on Day 3 postdose|All participants (healthy and with type 2 diabetes mellitus [T2DM]) who received at least 1 dose of study drug (LY2189265 or Placebo) with evaluable INSCmax(10-180) second response phase data.||picomole per liter (pmol/L)]||95% Confidence Interval|Geometric Mean
836749|NCT01300260|Primary|Area Under the Insulin Concentration-time Curve (AUC) - First Phase Response|On Day 1 of each treatment period, all participants (healthy or with type 2 diabetes mellitus [T2DM]) received a single subcutaneous dose of either LY2189265 or placebo. On Day 3 of each treatment period, participants underwent a 6-hour insulin infusion, followed by an intravenous (IV) dextrose 50% bolus to stimulate insulin secretion. Three hours later, participants were administered a second dextrose bolus, followed by an infusion of 20% dextrose and, 15 minutes after the start of the 20% dextrose infusion, a 1-mg glucagon bolus was administered. Area under the plasma insulin concentration time curve from 0 to 10 minutes (INSAUC[0-10]) following the first dextrose bolus (the first phase response) was corrected for baseline, where baseline was the mean of the insulin concentrations obtained between -30 and 0 minutes relative to the first dextrose bolus.|0-10 minutes after dextrose bolus on Day 3 postdose|All participants (healthy and with type 2 diabetes mellitus [T2DM]) who received at least 1 dose of study drug (LY2189265 or Placebo) with evaluable INSAUC(0-10) first phase response data.||picomole times hour per liter (pmol*h/L)||95% Confidence Interval|Geometric Mean
836750|NCT01300260|Primary|Maximum Insulin Concentration (Cmax) - First Phase Response|On Day 1 of each treatment period, all participants (healthy or with type 2 diabetes mellitus [T2DM]) received a single subcutaneous dose of either LY2189265 or placebo. On Day 3 of each treatment period, participants underwent a 6-hour insulin infusion, followed by an intravenous (IV) dextrose 50% bolus to stimulate insulin secretion. Three hours later, participants were administered a second dextrose bolus, followed by an infusion of 20% dextrose and, 15 minutes after the start of the 20% dextrose infusion, a 1-mg glucagon bolus was administered. Maximum plasma insulin concentration from 0 to 10 minutes (INSCmax[0-10]) following the first dextrose bolus (the first phase response) was corrected for baseline, where baseline was the mean of the insulin concentrations obtained between -30 and 0 minutes relative to the first dextrose bolus.|0-10 minutes after dextrose bolus on Day 3 postdose|All participants (healthy and with type 2 diabetes mellitus [T2DM]) who received at least 1 dose of study drug (LY2189265 or Placebo) with evaluable INSCmax(0-10) first response phase data.||picomole per liter (pmol/L)||95% Confidence Interval|Geometric Mean
836751|NCT01300286|Secondary|Cryoprecipitate Transfusion||Anesthesia Induction (Baseline), after CPB, ICU Admission (est. 6 hours after baseline) to post op day 2 (est: 30- 54 hr after baseline)|||mL||Standard Deviation|Mean
836752|NCT01300286|Secondary|Platelet Transfusion||Anesthesia Induction (Baseline), after CPB, ICU Admission (est. 6 hours after baseline) to post op day 2 (est: 30- 54 hr after baseline)|||mL||Inter-Quartile Range|Median
836753|NCT01300286|Secondary|Fresh Frozen Plasma Transfusion||Anesthesia Induction (Baseline), after CPB, ICU Admission (est. 6 hours after baseline) to post op day 2 (est: 30- 54 hr after baseline)|||mL||Inter-Quartile Range|Median
836754|NCT01300286|Secondary|Packed Red Blood Cell Transfusion||Anesthesia Induction (Baseline), after CPB, ICU Admission (est. 6 hours after baseline) to post op day 2 (est: 30- 54 hr after baseline)|||units||Inter-Quartile Range|Median
836755|NCT01300286|Primary|Fibrinogen Level Change|Fibrinogen levels will be assessed only at the timepoints listed in the timeframe and for a maximum of 24 hours.|Anesthesia Induction (Baseline), Pre RiaSTAP (est. 4 hr after baseline), Post RiaSTAP (est: 10 minutes after RiaSTAP administered), ICU Admission (est. 6 hours after baseline), 24 Hour post op (est: 24-30 hr after baseline)|||mg/dl||Standard Deviation|Mean
836756|NCT01300338|Primary|Mean Change in Diastolic Blood Pressure|Average change in diastolic blood pressure (bottom number of blood pressure reading) from baseline to 6 months.|Baseline, 6 months|||Millimeters of Mercury||95% Confidence Interval|Mean
836757|NCT01300338|Primary|Mean Change in Systolic Blood Pressure|Average change in systolic blood pressure (top number of blood pressure reading) from baseline to 6 months.|Baseline, 6 months|||Millimeters of Mercury||95% Confidence Interval|Mean
836758|NCT01300351|Secondary|Duration of Clinical Benefit|"Duration of clinical benefit (DoCB) will be evaluated only for patients who have CB, and is defined as the time from the date of randomisation until the date of disease progression or death from any cause, whichever is earlier.
Any patient who has not progressed or died by the date of DCO or who has been lost to follow up will be right censored at the date of their last evaluable disease assessment."|36 months|FAS||months||Inter-Quartile Range|Median
836759|NCT01300351|Secondary|Duration of Response|"Duration of response (DoR) will be evaluated only for patients who have an objective response, and is defined as the time from the date of first documentation of objective response (i.e., the initial visit at which CR or PR was recorded) until the date of disease progression or death due to any cause (whichever is earlier). The time of the initial response will be defined as the latest of the dates contributing towards the first visit response of PR or CR.
Any patient who has not progressed or died by the date of DCO, or who has been lost to follow up, will be right-censored at the date of their last disease assessment."|36 months|Evaluable for Response Set||months||Inter-Quartile Range|Median
836760|NCT01300351|Secondary|Clinical Benefit Rate|A clinical benefit (CB) responder is defined as a patient having a best overall response of either CR, PR or SD for at least 24 weeks per RECIST v1.1. As tumour assessments can occur ± 2 weeks of the specified time point, the CBR is defined as the proportion of patients in the FAS who have CB ≥ 22 weeks (or 154 days).|36 months|FAS||patients|||Number
836761|NCT01300351|Secondary|Objective Response Rate|The ORR is defined as the proportion of all randomized patients with measurable disease at baseline who have a best objective tumour response of either CR or PR per RECIST v1.1.|36 months|Evaluable for Response Set, included all patients in the FAS with measurable disease at baseline.||patients|||Number
836762|NCT01300351|Primary|Progression-free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, or unequivocal progression of existing non-target lesions, or the appearance of new lesions, or death (by any cause in the absence of progression). The primary analysis for PFS was the log rank test stratified by last endocrine therapy received prior to fulvestrant (AO vs. AI). The treatment effect was estimated using the HR of 500 mg fulvestrant to 250 mg fulvestrant together with the corresponding 95% CI and p value.|36 months|FAS: all randomised patients and compared the treatment groups on the basis of randomised treatment, regardless of treatment actually received.||months||Inter-Quartile Range|Median
836763|NCT01300455|Secondary|Mean AHI|"Evaluation of the effect of multiple dose administration of suvorexant on
AHI as measured by polysomnography. The AHI is an overall index of OSA severity. The AHI is calculated by dividing the number of apneas and hypopneas by the number of hours of sleep. AHI values are categorized as mild OSA = 5 to <15/hr and moderate OSA = 15 to <30/hr."|Day 1|Twenty-four of 26 participants were included in the primary evaluation of Day 1 AHI/SaO2 data; 2 participants had no data due to either not receiving placebo or an equipment malfunction.||Events per hour||95% Confidence Interval|Least Squares Mean
836764|NCT01300455|Secondary|Mean Arterial SaO2 for Different Sleep Stages|Comparison of the mean SaO2 during different sleep stages (REM, Non-REM, and awake) following multiple dose administration of suvorexant and placebo. Sleep stages were determined by polysomnography.|Day 1 and Day 4|Twenty-four of 26 participants were included in the primary evaluation of Day 1 AHI/SaO2 data; 2 participants had no data due to either not receiving placebo or an equipment malfunction. Twenty-five of 26 participants had Day 4 data; one participant did not receive placebo.||Percentage of Oxygen Saturation||95% Confidence Interval|Least Squares Mean
836765|NCT01300455|Secondary|Percentage of Total Sleep Time That Arterial SaO2 is Less Than 90%, 85%, and 80%|"Evaluation of the percentage of the night in which SaO2 is less than 90%, less
than 85% and less than 80% following multiple dose administration of
suvorexant and placebo. Total sleep time is the total of all REM and non-REM sleep in a sleep episode."|Day 1 and Day 4|Twenty-four of 26 participants were included in the primary evaluation of Day 1 AHI/SaO2 data; 2 participants had no data due to either not receiving placebo or an equipment malfunction. Twenty-five of 26 participants had Day 4 data; one participant did not receive placebo.||Percentage of Total Sleep Time||95% Confidence Interval|Mean
836766|NCT01300455|Secondary|Mean Arterial Oxygen Saturation (SaO2) During Total Sleep Time|Evaluation of the effect of multidose dose suvorexant on mean SaO2 during total sleep time as measured by pulse oximetry. Total sleep time is the total of all rapid eye movement (REM) and non-REM sleep in a sleep episode.|Day 1 and Day 4|Twenty-four of 26 participants were included in the primary evaluation of Day 1 AHI/SaO2 data; 2 participants had no data due to either not receiving placebo or an equipment malfunction. Twenty-five of 26 participants had Day 4 data; one participant did not receive placebo.||Percentage of Oxygen Saturation||95% Confidence Interval|Least Squares Mean
836767|NCT01300455|Primary|Number of Participants Who Discontinued Study Drug Due to an AE|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.|Up to 13 days|All participants were included in the Safety Population.||participants|||Number
836768|NCT01300455|Primary|Number of Participants With an Adverse Event|An adverse event (AE) is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.|Up to 14 days after last dose|All participants were included in the Safety Population.||participants|||Number
836769|NCT01300455|Primary|Mean Apnea-Hypopnea Index (AHI)|"Evaluation of the effect of multiple dose administration of suvorexant on
AHI as measured by polysomnography. The AHI is an overall index of obstructive sleep apnea (OSA) severity. The AHI is calculated by dividing the number of apneas and hypopneas by the number of hours of sleep. AHI values are categorized as mild OSA = 5 to <15/hr and moderate OSA = 15 to <30/hr."|Day 4|Twenty-five of 26 participants had Day 4 data; one participant did not receive placebo.||Events per hour||95% Confidence Interval|Least Squares Mean
836770|NCT01300546|Secondary|Percent Change in Headache Days All Treatment Periods Compared to Baseline|Comparing the number of migraine headache days during Baseline Period Days 1-30 to number or migraine headache days reported in Treatment Period Month 1 (Days 31-60), Treatment Period Month 2 (Days 61-90), and Treatment Period Month 3 (Days 91-120) in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. e.g., Percent change=[ (total headache days during Treatment Period Month 3 (Days 91-120)-total headache days during Baseline (Days 1-30)/total headache days during Baseline (Days 1-30)]*100%).|Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.|||percent change of migraine headache days||Standard Deviation|Mean
836771|NCT01300546|Secondary|Compliance With Lifestyle Changes|Self-assessed grade of compliance with lifestyle modification changes (where A=1, B=2, C=3, D=4, and F=5; lower scores represent better outcomes) in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm.|Day 121|||scores on a scale||Standard Deviation|Mean
836772|NCT01300546|Secondary|Migraine Disability Assessment Test (MIDAS)|"Change in MIDAS total score from end of Baseline (Day 31) to end Treatment Period month 3 (Day 121) in the Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm.
Total score of disability ranges:
0 to 5, MIDAS Grade I, Little or no disability
6 to 10, MIDAS Grade II, Mild disability
11 to 20, MIDAS Grade III, Moderate disability
21+, MIDAS Grade IV, Severe disability No subscales are present."|Baseline MIDAS collected at Day 31, Post final dose study medication MIDAS collected at Day 121.|||scores on a scale||Standard Deviation|Mean
836773|NCT01300546|Secondary|Percent Change of Doses of Study Medication|% change in number of doses during Baseline of triptans (Group A) and non-steroidal anti-inflammatory drugs(NSAIDs) (Group B) vs. doses during Treatment Period Months 1, 2, and 3 of study medication in the Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. e.g.,Percent change=[(number of doses during Treatment Period Month 3 (Days 91-120)- number of doses during Baseline (Days 1-30)/number of doses during Baseline (Days 1-30)]*100%). The total number of subjects used in this analysis is different than the total number of subjects as the analysis is only looking at those subjects that were taking one of the study medications during Baseline.|Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.|12 Subjects did not take any triptans (Group A) or NSAIDs (Group B) during Baseline Period and were not included in Matched Pairs analysis of study medication taken.||percent change of study medication||Standard Deviation|Mean
836775|NCT01300546|Secondary|Migraine Attacks With 50% Reduction|Number of subjects with at least a 50% reduction in number of migraine attacks reported in Baseline versus Treatment period Months 1, 2, and 3 in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm|Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.|||participants|||Number
836776|NCT01300546|Secondary|Headache Days With Greater Than 50% Reduction|Number of subjects with at least a 50% reduction in number of headache days reported in Baseline versus Treatment period Months 1, 2, and 3 in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm.|Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.|||participants|||Number
836777|NCT01300546|Secondary|Migraine Duration From Time of Treatment to Pain Free|"% change from Baseline in mean migraine duration from time of treatment to pain free reported in Treatment Period Months 1, 2, and 3 in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm.
Percent change=[(mean duration from treatment to painfree during Treatment Period Month 3 (Days 91-120)- mean duration from treatment to painfree during Baseline (Days 1-30)/mean duration from treatment to painfree during Baseline (Days 1-30)]*100%)."|Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.|||percent change of migraine duration||Standard Deviation|Mean
836778|NCT01300546|Secondary|Migraine Duration From Onset to Pain Free|Comparing mean migraine duration from onset to painfree from Baseline(Days 1-30) to each month: Treatment Period Months 1 (Days 31-60), 2(Days 61-90), and 3(Days 91-120) in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. Percent change was calculated by determining percent change in each subject, from Treatment Period Month 3 and Baseline, then comparing the average change between each arm. The following formula was used for each treatment period calculation. e.g.,Percent change=[(mean duration from onset to painfree during Treatment Period Month 3 (Days 91-120)- mean duration from onset to painfree during Baseline (Days 1-30)/mean duration from onset to painfree during Baseline (Days 1-30)]*100%).|Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.|||percent change of migraine duration||Standard Deviation|Mean
836779|NCT01300546|Secondary|Migraine Severity|Comparing migraine severity 2 hours after treatment from Baseline(Days 1-30) to migraine severity reported 2 hours after treatment in Treatment Period Months 1 (Days 31-60), 2(Days 61-90), and 3(Days 91-120) in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. Percent change was calculated by determining percent change in each subject, from Treatment Period Month 3 and Baseline, then comparing the average change between each arm. The following formula was used for each treatment period calculation. e.g.,Percent change=[ (mean migraine severity during Treatment Period Month 3 (Days 91-120)- mean migraine severity during Baseline (Days 1-30)/mean migraine severity during Baseline (Days 1-30)]*100%).|Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.|||percent change of migraine severity||Standard Deviation|Mean
836780|NCT01300546|Secondary|Migraine Attacks|Comparing the number of migraine attacks reported from Baseline to the number of migraine attacks reported in Treatment Period Months 1(Days 31-60), 2(Days 61-90), and 3(Days 91-120) in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. Each treatment month percent change was individually compared to Baseline. The following formula was used for each treatment period calculation. e.g.,Percent change=[ (total migraine attacks days during Treatment Period Month 3 (Days 91-120)-total migraine attacks during Baseline (Days 1-30)/total migraine attacks during Baseline (Days 1-30)]*100%).|Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.|||percent change of migraine attacks||Standard Deviation|Mean
836781|NCT01300546|Primary|Percent Change of Headache Days Compared to Baseline|Comparing the number of migraine headache days during Baseline Period Days 1-30 to number or migraine headache days reported in Treatment Period Days 91-120 in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. Percent change=[ (total headache days during Treatment Period Month 3 (Days 91-120)-total headache days during Baseline (Days 1-30)/total headache days during Baseline (Days 1-30)]*100%).|Day 121 (following 30 day Baseline Period and Treatment Period Days 91-120)|||percent change of headache days||Standard Deviation|Mean
836782|NCT01300559|Primary|Hemoglobin Measurement g/dl|The primary hypothesis was that use of the Aquamantys coagulation system in addition to unipolar cautery results in less intraoperative Hb loss compared with unipolar cautery alone during multilevel spinal decompression and fusion surgery.Intraoperatively, shed blood will be collected into a Cell-saver device. Surgical sponges will be recovered in a container of citrated normal saline. Prior to processing the salvaged blood from the cell-saver device, hemoglobin concentration (g/dL) and volume (dL) of the salvaged blood will be measured, allowing calculation of hemoglobin loss in grams.|At the end of surgery|Based on pilot data, it was estimated that 29 patients per group would provide 90% power with = 0.01 to distinguish such a difference between groups. Therefore, the randomized study was planned for 60 patients.||hemoglobin g/dl||95% Confidence Interval|Mean
836783|NCT01300624|Secondary|Communicative Effectiveness Ratings|"This questionnaire (Lomas et al, 1989) was provided to persons who communicated with the treatment participant regularly (e.g., a spouse). They rated how well the participant was able to perform on 16 common communication tasks (e.g., participating in a conversation over coffee). They rated each scenario along a line that spanned between the two extremes of ability, from not at all able to as able as before the stroke. The line was 100 mm. To score responses, the place where they bisected the line was measured. An average of their responses across the 16 questions was calculated."|pre-treatment, post-treatment and 3-months post-treatment (maintenance)|||units on a scale||Standard Deviation|Mean
836784|NCT01300624|Secondary|Western Aphasia Battery|Standardized measure of aphasia severity|pre-treatment and post-treatment|||units on a scale||Standard Deviation|Mean
836785|NCT01300624|Primary|Complete Utterances in Discourse|Sentence in discourse that were relevant to topic and syntactically correct|pre-treatment, post-treatment and 3-months post-treatment (maintenance)|||percentage of complete utterances||Standard Deviation|Mean
836786|NCT01300624|Secondary|Verb Naming|Confrontation of 100 action pictures|pre-treatment and post-treatment|||percentage of correct naming||Standard Deviation|Mean
836787|NCT01300624|Secondary|Noun Naming|Confrontation naming of 162 objects|pre-treatment and post-treatment|||percentage of correct naming||Standard Deviation|Mean
836788|NCT01300624|Primary|Untrained Sentence Probes|Picture description with sentences containing untrained words.|pre-treatment, post-treatment and 3-months post-treatment (maintenance)|||percentage of correct sentences||Standard Deviation|Mean
836792|NCT01300650|Secondary|Interval Change From Baseline in Heart Failure Symptoms as Measured by Duke Activity Status Index (DASI)|The Duke Activity Status Index (DASI) is a scale that quantifies patients' ability to perform various tasks. The scale ranges from 0 (unable to perform any tasks) to 58.20 (able to perform all tasks). Higher scores reflect improved activity or improved heart failure symptoms. Lower scores reflect worsened ability or worsened heart failure symptoms.|14 days|||units on a scale||Inter-Quartile Range|Median
836793|NCT01300650|Secondary|Interval Change From Baseline in Biomarkers (High-sensitivity C-reactive Protein, Whole Blood Assay, Brain Natriuretic Peptide)||14 days||||||
836794|NCT01300650|Primary|Median Interval Change From Baseline in the Minute Ventilation and Carbon Dioxide Production (VE/VCO2 Slope)|"The VE/VCO2 slope is calculated as the ratio of minute ventilation (VE) and carbon dioxide production (VCO2). Because these measurements share the same units, the resultant ratio is unitless.
Change in VE/VCO2 slope was calculated as the change in VE/VCO2 slope between baseline and 14 days. We therefore calculated the difference between VE/VCO2 slope measurements that occurred at baseline and at 14 days (change in VE/VCO2 slope = VE/VCO2 slope [day 14] - VE/VCO2 slope [baseline])"|14 days|||(unitless)||Inter-Quartile Range|Median
836795|NCT01300650|Primary|Median Interval Change From Baseline in Peak VO2|"Peak VO2 is a measurement of oxygen consumption rate during exercise (milliliters of oxygen per minute). It is calculated by continuous measurement of oxygen consumed during exercise while patients breath through a mask/tube. To account for variability in patient size, the oxygen consumption is divided by patient body weight.
The outcome measure time frame was 14 days. This means that change in peak VO2 was calculated as the difference between peak VO2 at baseline and 14 days. To calculate this change, we used the mathematical process of subtraction (change in peak VO2 = Peak VO2 [day 14] - Peak VO2 [baseline])"|14 days|||mL/kg/min||Inter-Quartile Range|Median
836796|NCT01300728|Secondary|Mean Cognitive Performance at 24 Months|"24 month cognitive performance in treatment (IVIG/placebo) is measured by:
Alzheimer Disease Assessment Scale-cognitive subscale (ADAS-cog)
Scale from 0 to 85 (0 is best cognitive performance)
Score is the sum of 12 sub-scales.
Mini Mental State Exam (MMSE)
Scale from 0 to 30 (30 is best cognitive performance)
Score is the sum of 11 sub-scales.
Clinical Dementia Rating - Sum of Boxes (CDR-SB)
Scale is 0 to 18 (0 is best cognitive performance)
Score is the sum of 6 sub-scales"|24 month|||units on a scale||Standard Deviation|Mean
836797|NCT01300728|Secondary|Mean Cognitive Performance at 12 Months|"12 month cognitive performance in treatment (IVIG/placebo) is measured by:
Alzheimer Disease Assessment Scale-cognitive subscale (ADAS-cog)
Scale from 0 to 85 (0 is best cognitive performance)
Score is the sum of 12 sub-scales.
Mini Mental State Exam (MMSE)
Scale from 0 to 30 (30 is best cognitive performance)
Score is the sum of 11 sub-scales.
Clinical Dementia Rating - Sum of Boxes (CDR-SB)
Scale is 0 to 18 (0 is best cognitive performance)
Score is the sum of 6 sub-scales"|12 months|||units on a scale||Standard Deviation|Mean
836798|NCT01300728|Secondary|Change in Ventricular Volume in Patients With Positive Cerebrospinal Fluid (CSF) Aβ1-42/CSF P-Tau181P Alzheimer Signature|Mean ventricular volume (cubic centimeters) in patients with positive cerebrospinal fluid (CSF) Aβ1-42/CSF P-Tau181P Alzheimer signature at 24 months following infusion|Baseline to 24 months following infusion|||cubic centimeters (cc)||Standard Deviation|Mean
836799|NCT01300728|Secondary|Number of Participants Who Converted From Amnestic Mild Cognitive Impairment (a-MCI) to Alzheimer Disease (AD)|The National Institute of Neurological and Communicative Disorders and Stroke - Alzheimers Disease and Related Disorders Association (NINCDS-ADRDA) Alzheimer's Criteria were proposed in 1984 by NINCDS-ADRDA criteria for diagnosing Alzheimer Disease and Clinical Dementia Rating (CDR) will be used to determine conversion from a-MCI to AD.|Baseline to 24 months|||participants|||Number
836800|NCT01300728|Primary|Annualized Percent Change in Ventricular Volume (APCV) as Measured by MRI|"Change in ventricular volumetric as measured by MRI at baseline, 12, and 24 months following the first infusion of either 0.4 g/kg NewGam or 0.9% saline solution(placebo) every 14 days x 5.
Participants will also be classified as early MCI (EMCI) if baseline CDR-SB is less than 1.5, and late MCI (LMCI) if CDR-SB is greater than or equal to 1.5."|Baseline, 12, and 24 month MRI evaluation|"Annualized Percent Change in ventricular volume (APCV) at 12 and 24 months was computed as:
((12 or 24 month volume) - (Baseline volume))/(Baseline volume)/(Time (years) between Baseline and 12 or 24 month visit)"||percent change per participant year||Standard Deviation|Mean
836801|NCT01300741|Primary|Purchase Intent|"As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. The participant was asked, How likely would you be to purchase these lenses? Purchase intent was graded on a 5-point Likert scale: Definitely would purchase, probably would purchase, may or may not purchase, probably would not purchase, definitely would not purchase. The Top-2-box response (definitely would purchase, probably would purchase) was calculated and reported as a percentage of all responses."|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as, major protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Percent likely to purchase|||Number
836802|NCT01300741|Primary|Overall Satisfaction|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall satisfaction was graded on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as, major protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Units on a Scale||Standard Deviation|Mean
836803|NCT01300741|Primary|Lens Awareness|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Lens awareness was graded on a 10-point scale, with 1 being very aware and 10 being not aware.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as, major protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Units on a Scale||Standard Deviation|Mean
836804|NCT01300741|Primary|Delivers a Healthy, Natural Feeling|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Delivers a healthy, natural feeling was graded on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as, major protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Units on a Scale||Standard Deviation|Mean
836823|NCT01300767|Primary|Comfort During the Day|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Comfort during the day was graded on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks|||Units on a Scale||Standard Deviation|Mean
836805|NCT01300741|Primary|Handling at Removal|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Handling at removal was graded on a 10-point scale, with 1 being difficult and 10 being easy.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as, major protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Units on a Scale||Standard Deviation|Mean
836806|NCT01300741|Primary|Handling on Insertion|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Handling on insertion was graded on a 10-point scale, with 1 being difficult and 10 being easy.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as, major protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Units on a Scale||Standard Deviation|Mean
836807|NCT01300741|Primary|Low Light Vision|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Low light vision was graded on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as, major protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Units on a Scale||Standard Deviation|Mean
836808|NCT01300741|Primary|Daytime Vision|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Daytime vision was graded on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as, major protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Units on a Scale||Standard Deviation|Mean
836809|NCT01300741|Primary|Overall Comfort|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall comfort was graded on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as, major protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Units on a Scale||Standard Deviation|Mean
836810|NCT01300741|Primary|Comfort at End of Day|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Comfort at end of day was graded on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as, major protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Units on a Scale||Standard Deviation|Mean
836811|NCT01300741|Primary|Comfort During the Day|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Comfort during the day was graded on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as, major protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Units on a Scale||Standard Deviation|Mean
836812|NCT01300741|Primary|Comfort on Insertion|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Comfort on insertion was graded on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as, major protocol deviations as determined by masked review; discontinuations; and/or missing responses||Units on a Scale||Standard Deviation|Mean
836813|NCT01300767|Primary|Purchase Intent|"As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. The participant was asked, How likely would you be to purchase these lenses? Purchase intent was graded on a 5-point Likert scale: Definitely would purchase, probably would purchase, may or may not purchase, probably would not purchase, definitely would not purchase. The Top-2-box response (definitely would purchase, probably would purchase) was calculated and reported as a percentage of all responses."|4 weeks|||Percent likely to purchase|||Number
836814|NCT01300767|Primary|Overall Satisfaction|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall satisfaction was graded on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks|||Units on a Scale||Standard Deviation|Mean
836815|NCT01300767|Primary|Lens Awareness|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Lens awareness was graded on a 10-point scale, with 1 being very aware and 10 being not aware.|4 weeks|||Units on a Scale||Standard Deviation|Mean
836816|NCT01300767|Primary|Delivers a Healthy, Natural Feeling|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Delivers a healthy, natural feeling was graded on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks|||Units on a Scale||Standard Deviation|Mean
836817|NCT01300767|Primary|Handling at Removal|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Handling at removal was graded on a 10-point scale, with 1 being difficult and 10 being easy.|4 weeks|||Units on a Scale||Standard Deviation|Mean
836818|NCT01300767|Primary|Handling on Insertion|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Handling on insertion was graded on a 10-point scale, with 1 being difficult and 10 being easy.|4 weeks|||Units on a Scale||Standard Deviation|Mean
836819|NCT01300767|Primary|Low Light Vision|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Low light vision was graded on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks|||Units on a Scale||Standard Deviation|Mean
836820|NCT01300767|Primary|Daytime Vision|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Daytime vision was graded on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks|||Units on a Scale||Standard Deviation|Mean
836821|NCT01300767|Primary|Overall Comfort|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall comfort was graded on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks|||Units on a Scale||Standard Deviation|Mean
836822|NCT01300767|Primary|Comfort at End of Day|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Comfort at end of day was graded on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks|||Units on a Scale||Standard Deviation|Mean
836824|NCT01300767|Primary|Comfort on Insertion|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Comfort on insertion was graded on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as, major protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Units on a Scale||Standard Deviation|Mean
836825|NCT01300819|Secondary|Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Miscellaneous|"The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in 9 different domains. Severity (ranges: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) and frequency (ranges: 1 = Rarely (<1/wk), 2 = Often (1/wk), 3 = Frequent (several times per week), 4 = Very Frequent (daily or all the time) are rated using a 4-point scale.
The final score is derived from multiplying the severity score and the frequency score.
A negative change from Baseline to end of Maintenance indicates an improvement in NMSS.
The possible min/max final scores per subdomain are calculated as follows:
Range of final score per subdomain: 0 – 12 per question multiplied by the number of questions per subdomain:
Subdomain Miscellaneous (4 questions): range 0 – 48"|From Baseline (Day 1) to end of 12-week Maintenance (Day 84)|This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.||scores on a scale||Standard Deviation|Mean
836826|NCT01300819|Secondary|Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Sexual Function|"The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in 9 different domains. Severity (ranges: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) and frequency (ranges: 1 = Rarely (<1/wk), 2 = Often (1/wk), 3 = Frequent (several times per week), 4 = Very Frequent (daily or all the time) are rated using a 4-point scale.
The final score is derived from multiplying the severity score and the frequency score.
A negative change from Baseline to end of Maintenance indicates an improvement in NMSS.
The possible min/max final scores per subdomain are calculated as follows:
Range of final score per subdomain: 0 – 12 per question multiplied by the number of questions per subdomain:
Subdomain Sexual function (2 questions): range 0 – 24"|From Baseline (Day 1) to end of 12-week Maintenance (Day 84)|This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.||scores on a scale||Standard Deviation|Mean
836827|NCT01300819|Secondary|Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Urinary|"The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in 9 different domains. Severity (ranges: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) and frequency (ranges: 1 = Rarely (<1/wk), 2 = Often (1/wk), 3 = Frequent (several times per week), 4 = Very Frequent (daily or all the time) are rated using a 4-point scale.
The final score is derived from multiplying the severity score and the frequency score.
A negative change from Baseline to end of Maintenance indicates an improvement in NMSS.
The possible min/max final scores per subdomain are calculated as follows:
Range of final score per subdomain: 0 – 12 per question multiplied by the number of questions per subdomain:
Subdomain Urinary (3 questions): range 0 – 36"|From Baseline (Day 1) to end of 12-week Maintenance (Day 84)|This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.||scores on a scale||Standard Deviation|Mean
836828|NCT01300819|Secondary|Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Gastrointestinal Tract|"The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in 9 different domains. Severity (ranges: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) and frequency (ranges: 1 = Rarely (<1/wk), 2 = Often (1/wk), 3 = Frequent (several times per week), 4 = Very Frequent (daily or all the time) are rated using a 4-point scale.
The final score is derived from multiplying the severity score and the frequency score.
A negative change from Baseline to end of Maintenance indicates an improvement in NMSS.
The possible min/max final scores per subdomain are calculated as follows:
Range of final score per subdomain: 0 – 12 per question multiplied by the number of questions per subdomain:
Subdomain Gastrointestinal tract (3 questions): range 0 – 36"|From Baseline (Day 1) to end of 12-week Maintenance (Day 84)|This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.||scores on a scale||Standard Deviation|Mean
836829|NCT01300819|Secondary|Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Attention/Memory,|"The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in 9 different domains. Severity (ranges: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) and frequency (ranges: 1 = Rarely (<1/wk), 2 = Often (1/wk), 3 = Frequent (several times per week), 4 = Very Frequent (daily or all the time) are rated using a 4-point scale.
The final score is derived from multiplying the severity score and the frequency score.
A negative change from Baseline to end of Maintenance indicates an improvement in NMSS.
The possible min/max final scores per subdomain are calculated as follows:
Range of final score per subdomain: 0 – 12 per question multiplied by the number of questions per subdomain:
Subdomain Attention/Memory (3 questions): range 0 – 36"|From Baseline (Day 1) to end of 12-week Maintenance (Day 84)|This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.||scores on a scale||Standard Deviation|Mean
836866|NCT01301079|Secondary|Hyperalgesia in the Postoperative Period as Measured With Algometer in Thenar Eminence|The mechanical pain threshold was evaluated using an algometer. The pressure was increased by 0.1 kgf/second until the patient complained of pain. The mean of three determinations was calculated.|24 h after the procedure|||kilogram force/second||Standard Deviation|Mean
836830|NCT01300819|Secondary|Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Perception/Hallucinations|"The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in 9 different domains. Severity (ranges: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) and frequency (ranges: 1 = Rarely (<1/wk), 2 = Often (1/wk), 3 = Frequent (several times per week), 4 = Very Frequent (daily or all the time) are rated using a 4-point scale.
The final score is derived from multiplying the severity score and the frequency score.
A negative change from Baseline to end of Maintenance indicates an improvement in NMSS.
The possible min/max final scores per subdomain are calculated as follows:
Range of final score per subdomain: 0 – 12 per question multiplied by the number of questions per subdomain:
Subdomain Perception/Hallucinations (3 questions): range 0 – 36"|From Baseline (Day 1) to end of 12-week Maintenance (Day 84)|This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.||scores on a scale||Standard Deviation|Mean
836831|NCT01300819|Secondary|Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Mood/Cognition|"The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in 9 different domains. Severity (ranges: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) and frequency (ranges: 1 = Rarely (<1/wk), 2 = Often (1/wk), 3 = Frequent (several times per week), 4 = Very Frequent (daily or all the time) are rated using a 4-point scale.
The final score is derived from multiplying the severity score and the frequency score.
A negative change from Baseline to end of Maintenance indicates an improvement in NMSS.
The possible min/max final scores per subdomain are calculated as follows:
Range of final score per subdomain: 0 – 12 per question multiplied by the number of questions per subdomain:
Subdomain Mood/Cognition (6 questions): range 0 – 72"|From Baseline (Day 1) to end of 12-week Maintenance (Day 84)|This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.||scores on a scale||Standard Deviation|Mean
836832|NCT01300819|Secondary|Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Sleep/Fatigue|"The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in 9 different domains. Severity (ranges: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) and frequency (ranges: 1 = Rarely (<1/wk), 2 = Often (1/wk), 3 = Frequent (several times per week), 4 = Very Frequent (daily or all the time) are rated using a 4-point scale.
The final score is derived from multiplying the severity score and the frequency score.
A negative change from Baseline to end of Maintenance indicates an improvement in NMSS.
The possible min/max final scores per subdomain are calculated as follows:
Range of final score per subdomain: 0 – 12 per question multiplied by the number of questions per subdomain:
Subdomain Sleep/Fatigue (4 questions): range 0-48"|From Baseline (Day 1) to end of 12-week Maintenance (Day 84)|This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.||scores on a scale||Standard Deviation|Mean
836833|NCT01300819|Secondary|Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Cardiovascular|"The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in 9 different domains. Severity (ranges: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) and frequency (ranges: 1 = Rarely (<1/wk), 2 = Often (1/wk), 3 = Frequent (several times per week), 4 = Very Frequent (daily or all the time) are rated using a 4-point scale.
The final score is derived from multiplying the severity score and the frequency score.
A negative change from Baseline to end of Maintenance indicates an improvement in NMSS.
The possible min/max final scores per subdomain are calculated as follows:
Range of final score per subdomain: 0 – 12 per question multiplied by the number of questions per subdomain:
Subdomain Cardiovascular (2 questions): range 0 – 24"|From Baseline (Day 1) to end of 12-week Maintenance (Day 84)|This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.||scores on a scale||Standard Deviation|Mean
836834|NCT01300819|Secondary|Change From Baseline to the End of Maintenance in Health-related Quality of Life (HRQL) Measured by a 39-item Parkinson's Disease Questionnaire (PDQ-39)|Parkinson's Disease Questionnaire - 39 (PDQ-39) is a self-administered questionnaire. It comprises of 39 questions, relating to eight key areas of health and daily activities, including both Motor and Non-motor symptoms. It is scored on a scale of zero to 100, with lower scores indicating better health and high scores more severe symptoms in change from Baseline to end of Maintenance.|From Baseline (Day 1) to end of 12-week Maintenance (Day 84)|This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.||scores on a scale||Standard Deviation|Mean
836835|NCT01300819|Secondary|Change From Baseline to the End of Maintenance in Total Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score|The Unified Parkinson's Disease Rating Scale (UPDRS) Part III is a scale for the assessment of function in Parkinson's Disease. UPDRS Part III measures Motor Function. It consists of 14 items with 27 questions, each ranging from 0 to 4. The sum score for the UPDRS Part III ranges from 0 to 108. A higher score indicates greater disability. A negative change from Baseline to end of Maintenance score indicates improvement.|From Baseline (Day 1) to end of 12-week Maintenance (Day 84)|This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.||scores on a scale||Standard Deviation|Mean
836847|NCT01301027|Primary|Change in High Sensitivity C-Reactive Protein (hsCRP) Concentration in Plasma From Baseline to 6 Months|The percent difference in hsCRP concentration geometric mean values from baseline to 6 months was calculated for each arm|Baseline and 6 months|1 participant in the Pioglitazone group and 2 participants in the Placebo group had blood samples collected after the 10 week visit and prior to their withdrawal. They did not complete the study, but their results were included in the 6-month analysis.||percent difference in geometric mean||95% Confidence Interval|Geometric Mean
836836|NCT01300819|Primary|Change From Baseline to the End of Maintenance in Total Nonmotor Symptoms Scale (NMSS) Score|The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson’s Disease (PD). The severity and frequency of the subject’s nonmotor symptoms is assessed by the investigator in the following 9 domain categories: cardiovascular, including falls; sleep/fatigue; mood/cognition; perceptual problems/hallucinations; attention/memory; gastrointestinal tract; urinary; sexual function; miscellaneous. Severity and frequency are rated using a 4-point scale ranging from 0 (none) to 3 (severe; major source of distress or disturbance to subject) for severity and from 1 (rarely) to 4 (very frequent [daily or all the time]) for frequency. The total NMSS score ranges from 0 to 350. A negative change from Baseline to end of Maintenance indicates an improvement in NMSS.|From Baseline (Day 1) to end of 12-week Maintenance (Day 84)|This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.||scores on a scale||Standard Deviation|Mean
836837|NCT01300923|Secondary|Brain-derived Neurotrophic Factor (BDNF)|BDNF is a protein that supports the survival of existing neurons and growth and differentiation of new neurons and synapses.|Screen and Week 10|||pg/mL||Standard Deviation|Mean
836838|NCT01300923|Secondary|Peabody Picture Vocabulary|The Peabody Picture Vocabulary Test is one of the most commonly used assessment tests that measure verbal ability in standard American English vocabulary. This test has been nationally standardized using examinees from various age groups, from children to adults. Thus, the raw scores are equated to mental age, using the norms obtained from standardization. The total standard scores range from 40 (worse receptive vocabulary) to 160 (better receptive vocabulary). The scores can also be converted to percentile rank.|Week 10|||units on a scale||Standard Deviation|Mean
836839|NCT01300923|Secondary|Vineland Adaptive Behavior Scales-II (VABS-II) Communication Domain|The VABS-II is a semi-structured interview designed to assess adaptive functioning in communication, daily living, socialization and motor skills. Recognizing that language is a major area of impairment in the study population, the Communication Domain (99 Items from 0-198), in particular the Expressive Subdomain (54 Items from 0-108) are of interest in this study. Items arranged in a developmental sequence are rated on a 3-point scale. Each item is scored from 0 (never performs the behavior) to 3 (usually performs the behavior independently). Higher scores indicate higher adaptive functioning. Differences between Baseline and Week 10 are used as an indicator of change.|Week 10|||units on a scale||Standard Deviation|Mean
836840|NCT01300923|Secondary|ADHD Rating Scale 4th Edition|The ADHD Rating Scale is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder. The ADHD Rating Scale-IV is completed by the parent and scored by a clinician. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. The total score can range from 0 to 54, with a higher score indicating greater severity.|Week 10|||units on a scale||Standard Deviation|Mean
836841|NCT01300923|Secondary|Children's Yale-Brown Obsessive Compulsive Scale Modified for PDD|The Children's Yale-Brown Obsessive Compulsive Scales-Modified (CY-BOCS) is a 5-item, semi-structured clinician rating scale modified designed to rate the current severity of repetitive behavior in children and adolescents with PDD. Once the current repetitive behaviors are identified, they are separately rated on 5 items: Time Spent, Interference, Distress, Resistance, and Control. Each of these items is scored on a 5-point scale form 0 (least symptomatic) to 4 (most symptomatic). The CY-BOCS yields a Total Score from 0 to 20 and is sensitive to change.|Week 10|||units on a scale||Standard Deviation|Mean
836842|NCT01300923|Secondary|Social Responsiveness Scale|The 65-item SRS is a standardized measure of the core symptoms of autism. Each item is scored on a 4-point Likert scale. The score of each individual item is summed to create a total raw score. A total scores results are as follows: 0-62: Within normal limits 63-79: Mild range of impairment 80-108: Moderate range of impairment 109-149: Severe range of impairment|Week 10|||units on a scale||Standard Deviation|Mean
836843|NCT01300923|Secondary|The Aberrant Behavior Checklist (ABC)|The Aberrant Behavior Checklist (ABC) is a 58-item rating scale used to assess maladaptive behaviors across five original subscales: Irritability (15 items from 0-45), Social Withdrawal (16 items from 0-48), Stereotypy (7 items from 0-21), Hyperactivity (16 items from 0-48), Inappropriate Speech (4 items from 0-12). Additionally, Social Avoidance, a newly developed four-item subscale (from 0-12) of the ABC that captures core social avoidance aspects of Fragile X Syndrome is reported. All items on the ABC are rated from 0 (not at all a problem) to 3 (the problem is severe in degree). Higher scores indicate greater maladaptive behaviors. Differences between Baseline and Week 10 are used as an indicator of change.|Week 10|||units on a scale||Standard Deviation|Mean
836844|NCT01300923|Primary|Clinical Global Impression- Severity Scale (CGI-S)|The Clinical Global Impression – Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.|Week 10|||units on a scale||Standard Deviation|Mean
836845|NCT01301027|Secondary|Change in Interleukin-6 (IL-6) Concentration in Plasma From Baseline to 6 Months|The percent difference in IL-6 concentration geometric mean values from baseline to 6 months was calculated for each arm|Baseline and 6 months|1 participant in the Pioglitazone group and 2 participants in the Placebo group had blood samples collected after the 10 week visit and prior to their withdrawal. They did not complete the study, but their results were included in the 6-month analysis.||percent difference in geometric mean||95% Confidence Interval|Geometric Mean
836846|NCT01301027|Secondary|Change in Tumor Necrosis Factor-α (TNF-α) Concentration in Plasma From Baseline to 6 Months|The percent difference in TNF-α concentration geometric mean values from baseline to 6 months was calculated for each arm|Baseline and 6 months|1 participant in the Pioglitazone group and 2 participants in the Placebo group had blood samples collected after the 10 week visit and prior to their withdrawal. They did not complete the study, but their results were included in the 6-month analysis.||percent difference in geometric mean||95% Confidence Interval|Geometric Mean
836867|NCT01301079|Primary|Pain 24 Hours|The scale measure pain after 24 hours (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10.|24 hours|||units on a scale||Standard Deviation|Mean
836848|NCT01301027|Primary|Change in High Molecular Weight Adiponectin (HMW-A) Concentration in Plasma From Baseline to 6 Months|The percent difference in HMW-A concentration geometric mean values from baseline to 6 months was calculated for each arm|Baseline and 6 months|1 participant in the Pioglitazone group and 2 participants in the Placebo group had blood samples collected after the 10 week visit prior to their withdrawal. They did not complete the study, but their results were included in the 6-month analysis.||percent difference in geometric mean||95% Confidence Interval|Geometric Mean
836849|NCT01301066|Primary|Change of Fasting Serum Low-density Lipoprotein Cholesterol (LDL-C) at 12 Weeks||12 weeks minus baseline|modified Intent To Treat (mITT) population included all randomized subjects who received at least 1 dose of study drug and had at least 1 on-treatment lipid assessment||mg/dL||Standard Deviation|Mean
836850|NCT01301079|Secondary|Serum Level of Interleukin (IL)-10 24 h After the Procedure|Blood samples were drawn in ethylenediaminetetraacetic acid (EDTA) tubes 24 h after the surgery. The blood was centrifuged to separate the plasma and was stored at -70°C. IL-6 was analyzed using the enzyme-linked immunosorbent assay (ELISA) methodology.|24 h after the procedure|||picogram/milliliter||Standard Deviation|Mean
836851|NCT01301079|Secondary|Serum Level of Interleukin (IL)-10 5h After the Procedure|Blood samples were drawn in ethylenediaminetetraacetic acid (EDTA) tubes 5 h after the surgery. The blood was centrifuged to separate the plasma and was stored at -70°C. IL-10 was analyzed using the enzyme-linked immunosorbent assay (ELISA) methodology.|5h after the procedure|||picogram/milliliter||Standard Deviation|Mean
836852|NCT01301079|Secondary|Serum Level of Interleukin (IL)-10 Before the Procedure|Blood samples were drawn in ethylenediaminetetraacetic acid (EDTA) tubes before the surgery. The blood was centrifuged to separate the plasma and was stored at -70°C. IL-6 was analyzed using the enzyme-linked immunosorbent assay (ELISA) methodology.|Baseline (Before the procedure)|||picogram/milliliter||Standard Deviation|Mean
836853|NCT01301079|Secondary|Serum Level of Interleukin (IL)-8 24 h After the Procedure|Blood samples were drawn in ethylenediaminetetraacetic acid (EDTA) tubes 24 h after the surgery. The blood was centrifuged to separate the plasma and was stored at -70°C. IL-8 was analyzed using the enzyme-linked immunosorbent assay (ELISA) methodology.|24 h after the procedure|||picogram/milliliter||Standard Deviation|Mean
836854|NCT01301079|Secondary|Serum Level of Interleukin (IL)-8 5 h After the Procedure|Blood samples were drawn in ethylenediaminetetraacetic acid (EDTA) tubes 5 h after the surgery. The blood was centrifuged to separate the plasma and was stored at -70°C. IL-8 was analyzed using the enzyme-linked immunosorbent assay (ELISA) methodology.|5 h after the procedure|||picogram/milliliter||Standard Deviation|Mean
836855|NCT01301079|Secondary|Serum Level of Interleukin (IL)-8 Before the Procedure|Blood samples were drawn in ethylenediaminetetraacetic acid (EDTA) tubes before the surgery. The blood was centrifuged to separate the plasma and was stored at -70°C. IL-8 was analyzed using the enzyme-linked immunosorbent assay (ELISA) methodology.|Baseline (Before the procedure)|||picogram/milliliter||Standard Deviation|Mean
836856|NCT01301079|Secondary|Serum Level of Interleukin (IL)-6 24 h After the Procedure|Blood samples were drawn in ethylenediaminetetraacetic acid (EDTA) tubes 24 h after the surgery. The blood was centrifuged to separate the plasma and was stored at -70°C. IL-6 was analyzed using the enzyme-linked immunosorbent assay (ELISA) methodology.|24 h after the procedure|||picogram/milliliter||Standard Deviation|Mean
836857|NCT01301079|Secondary|Serum Level of Interleukin (IL)-6 5 h After the Procedure|Blood samples were drawn in ethylenediaminetetraacetic acid (EDTA) tubes 5 h after the surgery. The blood was centrifuged to separate the plasma and was stored at -70°C. IL-6 was analyzed using the enzyme-linked immunosorbent assay (ELISA) methodology.|5 h after the procedure|||picogram/milliliter||Standard Deviation|Mean
836858|NCT01301079|Secondary|Serum Level of Interleukin (IL)-6 Before the Procedure|Blood samples were drawn in ethylenediaminetetraacetic acid (EDTA) tubes before the surgery. The blood was centrifuged to separate the plasma and was stored at -70°C. IL-6 was analyzed using the enzyme-linked immunosorbent assay (ELISA) methodology.|Baseline (Before the procedure)|||picogram/milliliter||Standard Deviation|Mean
836859|NCT01301079|Secondary|Allodynia as Detected With a Soft Brush in the Thenar Eminence 24 h After the Procedure|The evaluations using the soft brush were performed in the thenar eminence of the non dominant hand 24 h after the procedure|24 h after the procedure|||participants|||Number
836860|NCT01301079|Secondary|Allodynia as Detected With a Soft Brush in the Thenar Eminence Before the Procedure|The evaluations using the soft brush were performed in the thenar eminence of the nondominant hand before the procedure|Before the procedure (Baseline)|||participants|||Number
836861|NCT01301079|Secondary|Allodynia as Detected With a Soft Brush in the Periumbilical Region 24 h After the Procedure|The evaluations using the soft brush were performed 2–3 cm from the incision in the periumbilical region (where the large trocar was placed) 24 h after the procedure|24 h after the procedure|||participants|||Number
836862|NCT01301079|Secondary|Allodynia as Detected With a Soft Brush in the Periumbilical Region Before the Procedure|The evaluations using the soft brush were performed 2–3 cm from the incision in the periumbilical region (where the large trocar was placed) before the procedure|Before the procedure (Baseline)|||participants|||Number
836863|NCT01301079|Secondary|Extension of Hyperalgesia|The 300-g filament was used 24 hours after the operation to induce a stimulus and delineate the extent of hyperalgesia from the periumbilical region. The stimulus was started outside the periumbilical region, where no pain sensation was reported, and continued every 0.5 cm until the 4 points of the periumbilical scar were reached (top, right side, left side, and bottom). The first point where the patient complained of pain was marked. If no pain sensation was reported, the stimulus was terminated 0.5 cm from the incision. The distance of each point from the surgical incision was measured, and the sum of the distances of the points was determined.|24 hours after the procedure|||centimeter||Standard Deviation|Mean
836864|NCT01301079|Secondary|Hyperalgesia in the Postoperative Period as Measured With Algometer in the Periumbilical Region|The mechanical pain threshold was evaluated using an algometer. The pressure was increased by 0.1 kgf/second until the patient complained of pain. The mean of three determinations was calculated.|24 h after the procedure|||kilogram force/second||Standard Deviation|Mean
836865|NCT01301079|Secondary|Hyperalgesia in the Preoperative Period as Measured With Algometer in the Periumbilical Region|The mechanical pain threshold was evaluated using an algometer. The pressure was increased by 0.1 kgf/second until the patient complained of pain. The mean of three determinations was calculated.|Baseline (before the surgery)|||kilogram force/second||Standard Deviation|Mean
836879|NCT01301079|Secondary|Hyperalgesia in the Preoperative Period as Measured With Algometer in Thenar Eminence|The mechanical pain threshold was evaluated using an algometer. The pressure was increased by 0.1 kgf/second until the patient complained of pain. The mean of three determinations was calculated.|Baseline (before the procedure)|||kilogram force/second||Standard Deviation|Mean
836880|NCT01301079|Secondary|Hyperalgesia in the Postoperative Period as Measured With Monofilaments in the Periumbilical Region|The pain threshold was assessed using six von Frey monofilaments (0,05 g; 0,2 g; 2 g; 4 g; 10 g e 300 g) in the periumbilical region in the postoperative period (24h after the procedure). The use of different von Frey monofilaments, starting with the lightest and ending with the heaviest, was separated by at least 30 seconds to reduce any anticipated responses due to a new stimulation that was performed too soon after the preceding stimulation. Three assessments were made for each monofilament, and this was considered positive when the patient responded to two of the determinations for each monofilament.|24h after the procedure|||gram||Standard Deviation|Mean
836881|NCT01301079|Secondary|Hyperalgesia in the Preoperative Period as Measured With Monofilaments in the Periumbilical Region|The pain threshold was assessed using six von Frey monofilaments (0,05 g; 0,2 g; 2 g; 4 g; 10 g e 300 g) in the periumbilical region in the preoperative period. The use of different von Frey monofilaments, starting with the lightest and ending with the heaviest, was separated by at least 30 seconds to reduce any anticipated responses due to a new stimulation that was performed too soon after the preceding stimulation. Three assessments were made for each monofilament, and this was considered positive when the patient responded to two of the determinations for each monofilament.|Before the procedure (Baseline)|||gram||Standard Deviation|Mean
836882|NCT01301079|Secondary|Hyperalgesia in the Postoperative Period as Measured With Monofilaments in Thenar Eminence|The pain threshold was assessed using six von Frey monofilaments (0,05 g; 0,2 g; 2 g; 4 g; 10 g e 300 g) in thenar eminence in the postoperative period (24 hours after procedure). The use of different von Frey monofilaments, starting with the lightest and ending with the heaviest, was separated by at least 30 seconds to reduce any anticipated responses due to a new stimulation that was performed too soon after the preceding stimulation. Three assessments were made for each monofilament, and this was considered positive when the patient responded to two of the determinations for each monofilament.|24 hours after procedure|||gram||Standard Deviation|Mean
836883|NCT01301079|Secondary|Hyperalgesia in the Preoperative Period as Measured With Monofilaments in Thenar Eminence|The pain threshold was assessed using six von Frey monofilaments (0,05 g; 0,2 g; 2 g; 4 g; 10 g e 300 g) in thenar eminence in the preoperative period. The use of different von Frey monofilaments, starting with the lightest and ending with the heaviest, was separated by at least 30 seconds to reduce any anticipated responses due to a new stimulation that was performed too soon after the preceding stimulation. Three assessments were made for each monofilament, and this was considered positive when the patient responded to two of the determinations for each monofilament.|Before the procedure (Baseline)|||gram||Standard Deviation|Mean
836884|NCT01301079|Secondary|Morphine Consumption Within 24 h||24 hours|||milligram||Standard Deviation|Mean
836885|NCT01301079|Secondary|Time to First Morphine Supplementation||24 hours|||minutes||Full Range|Median
836886|NCT01301092|Secondary|)Maximum Concentration (Cmax) of LY2189265: Intramuscular (IM) to Subcutaneous (SC)|The results presented are Geometric Least Squares (LS) Mean. LS Mean values were controlled for participants, sequence, treatment, period and random error.|Predose up to 336 hours postdose|Participants in Part C who had pharmacokinetic (PK) data.||nanograms/milliliter (ng/mL)||90% Confidence Interval|Geometric Mean
836887|NCT01301092|Secondary|Area Under the Concentration Time Curve (AUC) of LY2189265: Intramuscular (IM) to Subcutaneous (SC)|AUC is AUC from time zero to infinity. The results presented are Geometric Least Squares (LS) Mean. LS Mean values were controlled for participants, sequence, treatment, period and random error.|Predose up to 336 hours postdose|Participants in Part C who had pharmacokinetic (PK) data.||nanograms*hour/milliliter (ng*h/mL)||90% Confidence Interval|Geometric Mean
836888|NCT01301092|Primary|Maximum Concentration (Cmax) of LY2189265: Subcutaneous (SC) to Intravenous (IV)|The results presented are Geometric Least Squares (LS) Mean. LS Mean values were controlled for participants, sequence, treatment, period and random error.|Predose up to 336 hours postdose|Participants in Part B who had pharmacokinetic (PK) data.||nanograms/milliliter (ng/mL)||90% Confidence Interval|Geometric Mean
836889|NCT01301092|Primary|Dose Normalized Area Under the Concentration Time Curve (AUC) of LY2189265: Subcutaneous (SC) to Intravenous (IV)|AUC is AUC from time zero to infinity. The results presented are Geometric Least Squares (LS) Mean. LS Mean values were controlled for participants, sequence, treatment, period and random error.|Predose up to 336 hours postdose|Participants in Part B who had pharmacokinetic (PK) data.||nanograms*hour/milliliter/milligram||90% Confidence Interval|Geometric Mean
836890|NCT01301274|Secondary|ICU Length of Stay|ICU length of stay (in days)|180 days|||days||Standard Deviation|Mean
836891|NCT01301274|Secondary|Mechanical Ventilation Free Days at 28 Day of Admission|mechanical ventilation free days at the first 28 day of starting mechanical ventilation, if the patient died the corresponding value is zero.|first 28 day after starting mechanical ventilation|||days||Standard Deviation|Mean
836892|NCT01301274|Secondary|Mortality at 28 Days|Mortality in both groups will be compared 28 days after admission|28 days after admission|The analysis was per intention to treat||participants|||Number
836893|NCT01301274|Primary|Serum Sodium Levels in Both Groups|Mean serum sodium level of each group will be compared at baseline and in the first 48 hours of IV fluid infusion|first 48 hours|||mEq/L||Standard Deviation|Mean
836894|NCT01301508|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. The SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Treatment-emergent were events between first dose of study medication and up to the end of study treatment (Day 42) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.|Baseline (Day 1) up to Day 42|Safety analysis population included all randomized participants with confirmed usage of the study medication.||participants|||Number
836895|NCT01301508|Other Pre-specified|Percentage of Participants With Decrease From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 14 and 42|ADSI score was used to measure the severity of participant’s AD affected lesion. It evaluated 5 signs of AD (erythema, pruritus, exudation, excoriation and lichenification) in each lesion. Each sign was rated by investigator on a scale of 0 (none) to 3 (severe), where higher score indicated more severe condition. Total ADSI score for each lesion was sum of scores of the 5 signs and ranged from 0 (none) to 15 (most severe), where higher score indicated more severe condition. Percentage of participants in whom the active lesion (ointment treated) achieved a greater decrease from baseline to Days 14, 42 in ADSI as compared to vehicle lesion (vehicle treated) and, in whom the vehicle lesion (vehicle treated) achieved a greater decrease from baseline to Days 14, 42 as compared to active lesion (ointment treated) were reported in this outcome measure.|Baseline (Day 1), Day 14, Day 42|ITT population included all randomized participants who received study medication.||percentage of participants|||Number
836896|NCT01301508|Primary|Percentage of Participants With Decrease From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 28|ADSI score was used to measure the severity of participant’s AD affected lesion. It evaluated 5 signs of AD (erythema, pruritus, exudation, excoriation and lichenification) in each lesion. Each sign was rated by investigator on a scale of 0 (none) to 3 (severe), where higher score indicated more severe condition. Total ADSI score for each lesion was sum of scores of the 5 signs and ranged from 0 (none) to 15 (most severe), where higher score indicated more severe condition. Percentage of participants in whom the active lesion (ointment treated) achieved a greater decrease from baseline to Day 28 in ADSI as compared to vehicle lesion (vehicle treated) and, in whom the vehicle lesion (vehicle treated) achieved a greater decrease from baseline to Day 28 as compared to active lesion (ointment treated) were reported in this outcome measure.|Baseline (Day 1), Day 28|ITT population included all randomized participants who received study medication.||percentage of participants|||Number
836897|NCT01301508|Primary|Atopic Dermatitis Severity Index (ADSI) Score at Day 42|ADSI score was used to measure the severity of participant’s AD affected lesion. It evaluated 5 signs of AD (erythema, pruritus, exudation, excoriation and lichenification) in each lesion. Each sign was rated by investigator on a scale of 0 (none) to 3 (severe), where higher score indicated more severe condition. Total ADSI score for each lesion was sum of scores of the 5 signs and ranged from 0 (none) to 15 (most severe), where higher score indicated more severe condition.|Day 42|ITT population included all randomized participants who received study medication.||units on a scale||Standard Deviation|Mean
836898|NCT01301508|Primary|Atopic Dermatitis Severity Index (ADSI) Score at Day 28|ADSI score was used to measure the severity of participant’s AD affected lesion. It evaluated 5 signs of AD (erythema, pruritus, exudation, excoriation and lichenification) in each lesion. Each sign was rated by investigator on a scale of 0 (none) to 3 (severe), where higher score indicated more severe condition. Total ADSI score for each lesion was sum of scores of the 5 signs and ranged from 0 (none) to 15 (most severe), where higher score indicated more severe condition.|Day 28|ITT population included all randomized participants who received study medication.||units on a scale||Standard Deviation|Mean
836899|NCT01301508|Primary|Atopic Dermatitis Severity Index (ADSI) Score at Day 14|ADSI score was used to measure the severity of participant’s AD affected lesion. It evaluated 5 signs of AD (erythema, pruritus, exudation, excoriation and lichenification) in each lesion. Each sign was rated by investigator on a scale of 0 (none) to 3 (severe), where higher score indicated more severe condition. Total ADSI score for each lesion was sum of scores of the 5 signs and ranged from 0 (none) to 15 (most severe), where higher score indicated more severe condition.|Day 14|ITT population included all randomized participants who received study medication.||units on a scale||Standard Deviation|Mean
836900|NCT01301508|Primary|Atopic Dermatitis Severity Index (ADSI) Score at Baseline (Day 1)|ADSI score was used to measure the severity of participant’s atopic dermatitis (AD) affected lesion. It evaluated 5 signs of AD (erythema, pruritus, exudation, excoriation and lichenification) in each lesion. Each sign was rated by investigator on a scale of 0 (none) to 3 (severe), where higher score indicated more severe condition. Total ADSI score for each lesion was sum of scores of the 5 signs and ranged from 0 (none) to 15 (most severe), where higher score indicated more severe condition.|Baseline (Day 1)|The intent-to-treat (ITT) population included all randomized participants who received study medication.||units on a scale||Standard Deviation|Mean
836901|NCT01301729|Secondary|Time to Progression|Time to progression was defined as the time from the date of enrollment until the date of progressive disease.|From the date of enrollment until the date of progressive disease (up to 28 months)|ITT data set is defined as all the participants who are eligible through screening, register and enter the study.||months||95% Confidence Interval|Median
836902|NCT01301729|Secondary|Clinical Benefit Rate|Clinical benefit rate was assessed according to RECIST 1.0 and defined as the percentage of participants who experienced a CR, PR, or stable disease (SD) for at least 6 months. CR was defined as complete disappearance of all target and non-target lesions and no new lesions. PR was defined as greater than or equal to (≥) 30 % decrease in the sum of appropriate diameters of all target measurable lesions, no progress in the non-measurable disease, and no new lesions. SD was defined as small changes that do not meet above criteria.|up to 28 months|ITT data set is defined as all the participants who are eligible through screening, register and enter the study.||percentage of participants||95% Confidence Interval|Number
836903|NCT01301729|Secondary|Determination of Biomarkers Indicative for Response (Serum and Tumour Tissue Analyses)||up to 28 months|Biomarker analysis was not performed as the eligible biomarker sample quantity was too limited for testing.|||||
836904|NCT01301729|Secondary|Percentage of Participants With an Adverse Event (AE)|An AE was defined as any adverse medical event that occurred after the participant used the investigational medicinal product (IMP) or other intervention behaviors specified by the protocol in the clinical trial regardless of relationship to the study treatment.|Up to 28 days after last infusion of the study drug (28 months)|Safety population is defined as all enrolled participants and have taken at least one dose of study drug.||percentage of participants|||Number
836905|NCT01301729|Secondary|Overall Survival|Overall survival was defined as the time from the date of enrollment to the date of death due to any cause.|Time from enrollment to the date of death (up to 28 months)|ITT data set is defined as all the participants who are eligible through screening, register and enter the study.||months||95% Confidence Interval|Median
836906|NCT01301729|Secondary|Duration of Response|Duration of response was defined as the time from when a PR or CR was first documented until the date of documented PD or death. CR was defined as complete disappearance of all target and non-target lesions and no new lesions. PR was defined as greater than or equal to (≥) 30 % decrease in the sum of appropriate diameters of all target measurable lesions, no progress in the non-measurable disease, and no new lesions. PD was defined as 20% increase in the sum of the longest diameter of target lesions.|From the time of PR or CR until the date of PD or death (up to 28 months)|ITT data set is defined as all the participants who are eligible through screening, register and enter the study. Here, number of participants are the participants who had response.||months||95% Confidence Interval|Median
836907|NCT01301729|Secondary|Overall Response Rate|Overall response rate was assessed using RECIST 1.0 and defined as the percentage of participants that achieved a complete response (CR) or a partial response (PR). CR was defined as complete disappearance of all target and non-target lesions and no new lesions. PR was defined as greater than or equal to (≥) 30 % decrease in the sum of appropriate diameters of all target measurable lesions, no progress in the non-measurable disease, and no new lesions.|up to 28 months|ITT data set is defined as all the participants who are eligible through screening, register and enter the study.||percentage of participants||95% Confidence Interval|Number
836908|NCT01301729|Primary|Progression-Free Survival (PFS)|PFS was assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.0 and was defined as the time from the date when the participant signed the informed consent form (ICF) until death or progressive disease (PD). PD was defined as 20% increase in the sum of the longest diameter of target lesions. PFS and associated confidence intervals were calculated using the Kaplan-Meier method.|From the date of informed consent to the date of death or progressive disease (up to 28 months)|Intention to treat (ITT) data set is defined as all the participants who are eligible through screening, register and enter the study.||months||95% Confidence Interval|Median
836909|NCT01301742|Secondary|Total Empa: Area Under the Curve 0 to Time of Last Quantifiable Data Point (AUC0-tz)|"Area under the plasma concentration-time curve of the analyte from time 0 to the time of the last quantifiable data point.
The standard deviation presented in the analyses is actually the intra-individual geometric standard deviation (gCV)."|0 minutes (min), 20 min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 23h, 36h, 47h, 71h after the first dose|PK set: All subjects who had taken at least 1 dose of trial medication who provided at least 1 observation for at least 1 primary pharmacokinetic (PK) endpoint without an important protocol violation with respect to the PK evaluation.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
836910|NCT01301742|Primary|Total Empa: Maximum Measured Concentration (Cmax)|"Maximum measured concentration of total Empagliflozin (Empa) in plasma, per period.
The standard deviation presented in the analysis is actually the intra-individual geometric standard deviation (gCV)."|0 minutes (min), 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 23h, 36h, 47h, 71h after the first dose|PK set: All subjects who had taken at least 1 dose of trial medication who provided at least 1 observation for at least 1 primary pharmacokinetic (PK) endpoint without an important protocol violation with respect to the PK evaluation.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
836911|NCT01301742|Primary|Total Empa: Area Under the Curve 0 to Infinity (AUC0-∞)|"Area under the plasma concentration-time curve of the analyte from time 0 extrapolated to infinity.
The standard deviation presented in the analysis is actually the intra-individual geometric standard deviation (gCV)."|0 minutes (min), 20 min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 23h, 36h, 47h, 71h after the first dose|PK set: All subjects who had taken at least 1 dose of trial medication who provided at least 1 observation for at least 1 primary pharmacokinetic (PK) endpoint without an important protocol violation with respect to the PK evaluation.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
836912|NCT01301833|Secondary|Change From Baseline in Fasting Immuno Reactive Insulin (IRI) at Week 52||Baseline and 52 weeks|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after the treatment of study drug. Analysis based on last observation carried forward, where the last postbaseline observed value was carried forward and used for Week 52 where data was missing.||μU / mL||Standard Deviation|Mean
836913|NCT01301833|Secondary|Change From Baseline in Fasting Glucagon at Week 52||Baseline and 52 weeks|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after the treatment of study drug. Analysis based on last observation carried forward, where the last postbaseline observed value was carried forward and used for Week 52 where data was missing.||pg / mL||Standard Deviation|Mean
836914|NCT01301833|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 52||Baseline and 52 weeks|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after the treatment of study drug. Analysis based on last observation carried forward, where the last postbaseline observed value was carried forward and used for Week 52 where data was missing.||mg / dL||Standard Deviation|Mean
836915|NCT01301833|Secondary|Change From Baseline in HbA1c at Week 52||Baseline and 52 weeks|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after the treatment of study drug. Analysis based on last observation carried forward, where the last postbaseline observed value was carried forward and used for Week 52 where data was missing.||Percent||Standard Deviation|Mean
836916|NCT01301833|Primary|Number of Participants With Adverse Events|Treatment-emergent adverse events (TEAE) were defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after receiving the last dose of study drug.|52 Weeks|Safety set, consisting of all patients, who received at least one dose of study drug and who had at least one safety data after the treatment of study drug.||participants|||Number
836917|NCT01301950|Secondary|To Compare the Differences in Operating Room Efficiency as a Function of Institution Type and Geographical Location||Intraoperative|No operating room efficiency data was analyzed as a function of geography and institution, resulting in a sample size of 0.|||||
836918|NCT01301950|Secondary|Costs Associated With Conventional Versus TruMatch® Total Knee Arthroplasty Surgical Procedures|Compare costs associated with surgery using conventional surgical technique versus TruMatch® primary total knee replacements .|Intraoperative (Total duration of procedure)|No cost data were collected, resulting in a sample size of 0.|||||
836919|NCT01301950|Secondary|Turnover Time (Time to Clean Operating Room After Surgery is Completed)|Turnover Time for conventional versus TruMatch® primary total knee replacements as recorded by video time analysis [minutes].|Intraoperative (Time to clean Operating Room after surgery is completed)|1 site (9 subjects) was excluded from Turnover Time analysis as this substep could not be accurately assessed due to unexpected difficulties during video collection.||minutes||Standard Deviation|Mean
836920|NCT01301950|Secondary|Operating Room Setup - Operating Room Cleaned up From Previous Case to Surgical Draping Complete|Operating Room setup time for conventional versus TruMatch® primary total knee replacements as recorded by video time analysis [minutes]|Intraoperative (Operating Room cleaned up from previous case to surgical draping complete)|||minutes||Standard Deviation|Mean
836921|NCT01301950|Primary|Surgical Procedure Time to Compare Skin-to-Skin Time for Conventional Versus TruMatch® Primary Total Knee Replacements|Skin-to skin time for conventional versus TruMatch® primary total knee replacements (recorded by Investigator on Operative case report forms).|Intraoperative (Time from first incision to first stitch)|||minutes||Standard Deviation|Mean
836922|NCT01301963|Secondary|Compare Need for Remobilization Between Mobilization Groups|Using the Chi-square test or Fisher's exact test, as appropriate.|Day 1||||||
836923|NCT01301963|Secondary|Compare Need for Hospitalization During Mobilization Between Mobilization Groups||Day 1||||||
836924|NCT01301963|Secondary|Compare Days of Apheresis Between Mobilization Groups|Using the Wilcoxon Rand Sum Test|Day 1||||||
836925|NCT01301963|Secondary|Compare Hematopoietic Stem Cells/kg Collections Between Different Mobilization Regimens in Those Patients Who Are Crossed Over From One Mobilization Regimen to the Other|Patients will be randomized to receive either G-CSF or Plerixafor with G-CSF. All patients will undergo at least 2 days of leukopheresis. Cells/kg between these 2 arms will be compared. For those patients that do not reach the target goal will undergo a wash-out period and cross over to the other study arm.|By day 1||||||
836926|NCT01301963|Secondary|Percentage of Patients Achieving Target Goal CD34+ Cells Dose||In =< 5 days of leukaphereses|Due to low enrollment (10% of anticipated participants), no analysis is being done on data collected in this study|||||
836927|NCT01301963|Primary|Ability to Reach Target Collection of 5 x 10^6 CD34+ Cells/kg||In =< 2 days of leukaphereses|due to low enrollment (10% of anticipated participants), no analysis is being done on data collected in this study|||||
836928|NCT01302041|Secondary|PSA Doubling Time|PSA doubling time was to be calculated from the slope estimated from a linear regression of the natural log of PSA fitted on time, if the slope was positive. Since the slope was negative for all participants, PSA doubling time could not be calculated.|From Baseline to Week 25|Safety Analysis Set with a positive PSA versus time slope|||||
836929|NCT01302041|Secondary|Time to PSA Progression|Time to PSA progression is defined as the time interval from the first study drug dose to the first date of PSA progression. PSA progression is defined as a ≥ 25% increase in PSA with an absolute increase of ≥ 2 ng/mL above the nadir unless the PSA next measurement(s), if available, does not confirm the PSA progression.|From first dose until the data cut-off date of 28 December 2013; median duration of treatment was 754.0 days (range of 52-929 days).|Safety Analysis Set||days||Inter-Quartile Range|Median
836930|NCT01302041|Secondary|Time to PSA ≤ 0.1 ng/ml|"Time to PSA ≤ 0.1 ng/ml is defined as the time interval from the first study drug dose to the first date a decline in PSA to a result of 0.1 ng/ml or below was recorded.
Time to PSA ≤ 0.1 ng/ml was estimated using the Kaplan-Meier method."|From first dose until the data cut-off date of 28 December 2013; median duration of treatment was 754.0 days (range of 52-929 days).|Safety Analysis Set||days||Inter-Quartile Range|Median
836931|NCT01302041|Secondary|Time to PSA ≤ 4 ng/ml|Time to PSA ≤ 4 ng/ml is defined as the time interval from the first study drug dose to the first date a decline in PSA to a result of 4 ng/ml or below was recorded. Time to PSA ≤ 4 ng/ml was estimated using the Kaplan-Meier method.|From first dose until the data cut-off date of 28 December 2013; median duration of treatment was 754.0 days (range of 52-929 days).|Safety Analysis Set||days||Inter-Quartile Range|Median
836932|NCT01302041|Secondary|Time to PSA Decline ≥ 90%|Time to PSA decline ≥ 90% is defined as the time interval from the first study drug dose to the first date a decline from Baseline in PSA level of 90% or greater was recorded. Time to PSA decline ≥ 90% was estimated using the Kaplan-Meier method.|From first dose until the data cut-off date of 28 December 2013; median duration of treatment was 754.0 days (range of 52-929 days)|Safety Analysis Set||days||Inter-Quartile Range|Median
836933|NCT01302041|Secondary|Time to PSA Response|Time to PSA response (PSA decline ≥ 80% from Baseline) is defined as the time interval from the first study drug dose to the first date a decline from Baseline in PSA level of 80% or greater was recorded. Time to response was estimated using the Kaplan-Meier method.|From first dose until the data cut-off date of 28 December 2013; median duration of treatment was 754.0 days (range of 52-929 days)|Safety Analysis Set||days||Inter-Quartile Range|Median
836934|NCT01302041|Secondary|Maximum Decline From Baseline in PSA|The maximum decline from Baseline in PSA was calculated as the largest reduction from Baseline in PSA level that occurred at any point after treatment start up to Week 25 and up to and including the assessment made at the safety follow-up visit, divided by the PSA Baseline value and multiplied by 100, i.e., the maximum percent change from baseline.|Baseline to Week 25 and from Baseline up to the data cut-off date of 28 December 2013; median duration of treatment was 754.0 days (range of 52-929)|Safety Analysis Set||percent change||Standard Deviation|Mean
836935|NCT01302041|Secondary|Percentage of Participants With PSA ≤ 0.1 ng/ml|"Participants with unknown or missing PSA results at Week 25 or who discontinued prior to Week 25 were considered non-responders at Week 25.
Participants with unknown or missing PSA results at Week 49 or Week 97 were considered non-responders."|Weeks 25, 49 and 97|Safety Analysis Set; Week 49 and 97 analyses include participants who were on study at each time point.||percentage of participants|||Number
836936|NCT01302041|Secondary|Percentage of Participants With PSA ≤ 4 ng/ml|"Participants with unknown or missing PSA results at Week 25 or who discontinued prior to Week 25 were considered non-responders at Week 25.
Participants with unknown or missing PSA results at Week 49 or Week 97 were considered non-responders."|Weeks 25, 49 and 97|Safety Analysis Set; Week 49 and 97 analyses include participants who were on study at each time point.||percentage of participants|||Number
837731|NCT01308476|Secondary|Physicians Recommendation of the SMS System|Only physicians of patients in the SMS reminder group were asked if they would recommend the SMS system (no, yes, don't know)|Visit 2 (12 weeks) and visit 3 (24 weeks)|FAS for SMS reminder group only||Percentage of participants|||Number
836937|NCT01302041|Secondary|Percentage of Participants With a 90% or Greater Reduction From Baseline in PSA Level|"Participants with unknown or missing PSA results at Week 25 or who discontinued prior to Week 25 were considered non-responders at Week 25.
Participants with unknown or missing PSA results at Week 49 or Week 97 were considered non-responders."|Baseline and Weeks 25, 49 and 97|Safety Analysis Set; Week 49 and 97 analyses include participants who were on study at each time point.||percentage of participants|||Number
836938|NCT01302041|Secondary|Percentage of Participants With a PSA Response at Weeks 49 and 97|A PSA response was defined as a decline from baseline in PSA level of 80% or greater. Blood samples for PSA were collected and analyzed at a central laboratory. Participants with an unknown or missing response or who discontinued prior to Week 49 or Week 97 for any reason were treated as non-responders.|Baseline and Weeks 49 and 97|Safety Analysis Set||percentage of participants||95% Confidence Interval|Number
836939|NCT01302041|Secondary|Plasma Concentration of Enzalutamide Metabolite M2 at Pre-dose (Ctrough)||Pre-dose at Weeks 2, 3, 4, 5, 9, 13, 21 and 25|"Pharmacokinetic Analysis Set with available data at each time point (indicated by N)."||μg/mL||Standard Deviation|Mean
836940|NCT01302041|Secondary|Plasma Concentration of Enzalutamide at Pre-dose (Ctrough)||Pre-dose at Weeks 2, 3, 4, 5, 9, 13, 21 and 25|"Pharmacokinetic Analysis Set (participants who had taken at least 1 dose of study drug and who had at least 1 pharmacokinetic concentration value) with available data at each time point (indicated by N)."||μg/mL||Standard Deviation|Mean
836941|NCT01302041|Secondary|Percent Change From Baseline in Free Testosterone||Baseline and Weeks 25 and 49|"Safety Analysis Set with available data at each time point (Indicated by N)"||percent change||Standard Deviation|Mean
836942|NCT01302041|Secondary|Percent Change From Baseline in Total Testosterone||Baseline and Weeks 25 and 49|"Safety Analysis Set with available data at each time point (indicated by N)"||percent change||Standard Deviation|Mean
836943|NCT01302041|Secondary|Percent Change From Baseline in Prolactin||Baseline and Weeks 25 and 49|"Safety Analysis Set with available data at each time point (Indicated by N)"||percent change||Standard Deviation|Mean
836944|NCT01302041|Secondary|Percent Change From Baseline in Luteinizing Hormone (LH)||Baseline and Weeks 25 and 49|"Safety Analysis Set with available data at each time point (Indicated by N)"||percent change||Standard Deviation|Mean
836945|NCT01302041|Secondary|Percent Change From Baseline in Follicle-stimulating Hormone (FSH)||Baseline and Weeks 25 and 49|"Safety Analysis Set with available data at each time point (Indicated by N)"||percent change||Standard Deviation|Mean
836946|NCT01302041|Secondary|Percent Change From Baseline in Estradiol||Baseline and Weeks 25 and 49|"Safety Analysis Set with available data at each time point (indicated by N)"||percent change||Standard Deviation|Mean
836947|NCT01302041|Secondary|Percent Change From Baseline in Dihydrotestosterone (DHT)||Baseline and Week 25 and 49|"Safety Analysis Set with available data at each time point (indicated by N)"||percent change||Standard Deviation|Mean
836948|NCT01302041|Secondary|Percent Change From Baseline in Dehydroepiandrosterone (DHEA)||Baseline and Weeks 25 and 49|"Safety Analysis Set with available data at each time point (indicated by N)"||percent change||Standard Deviation|Mean
836949|NCT01302041|Secondary|Percent Change From Baseline in Androstenedione||Baseline and Weeks 25 and 49|"Safety Analysis Set with available data at each time point (indicated by N)"||percent change||Standard Deviation|Mean
836950|NCT01302041|Secondary|Percent Change From Baseline in Sex Hormone-binding Globulin (SHBG)||Baseline and Weeks 25 and 49|"Safety Analysis Set with available data at each time point (indicated by N)"||percent change||Standard Deviation|Mean
836951|NCT01302041|Secondary|Percent Change From Baseline in PSA||Baseline and Weeks 25, 49 and 97|"Safety Analysis Set with available data at each time point (indicated by N)"||percent change||Standard Deviation|Mean
836952|NCT01302041|Secondary|Number of Participants With Adverse Events|"Each adverse events (AE) was assessed by the investigator for causal relationship to the study drug; those deemed possibly or probably related to study drug are reported as drug regimen related AEs (DRRAEs).
A serious adverse event (SAE) was defined as any untoward medical occurrence that at any dose:
Resulted in death
Was life-threatening
Resulted in persistent or significant disability/incapacity
Resulted in congenital anomaly or birth defect
Required inpatient hospitalization or led to prolongation of hospitalization
Other medically important events."|From first dose of study drug until 30 days after last dose. Adverse events with an onset date occurring within 2 years (i.e., before or on Day 730), as of the cut-off date of 28 December 2013, are reported.|Safety Analysis Set||participants|||Number
836953|NCT01302041|Primary|Percentage of Participants With a Prostate-specific Antigen (PSA) Response at Week 25|"A PSA response was defined as a decline from Baseline in PSA level of 80% or greater. Blood samples for PSA were collected and analyzed at a central laboratory.
Participants with an unknown or missing response or who discontinued prior to Week 25 for any reason were treated as non-responders."|Baseline and Week 25|Safety Analysis Set (all participants who had taken at least 1 dose of study drug)||percentage of participants||95% Confidence Interval|Number
836954|NCT01293006|Secondary|Mean Arterial SaO2 During Total Sleep Time|Evaluation of the effect of multiple dose suvorexant on mean oxygen saturation (SaO2) during total sleep time as measured by pulse oximetry. Lower SaO2 values are associated with sleep impairment. Total sleep time is the total of all rapid eye movement (REM) and non-REM sleep in a sleep episode.|Day 1 of each period|Twenty-four of the 25 participants were included in the primary evaluation of SaO2 and AHI data; one participant was excluded due to a protocol violation.||Percentage of Oxygen Saturation||95% Confidence Interval|Least Squares Mean
836955|NCT01293006|Secondary|Mean Arterial SaO2 for Different Sleep Stages|Comparison of the mean SaO2 during different sleep stages (REM, Non-REM, and awake) following multiple dose administration of suvorexant and placebo. Lower SaO2 values are associated with sleep impairment. Sleep stages were determined by polysomnography.|Day 1 and Day 4 of each period|Twenty-four of the 25 participants were included in the primary evaluation of SaO2 and AHI data; one participant was excluded due to a protocol violation. During the Placebo periods, there were 22 evaluable participants at Day 4; 2 participants had either no data or missing data.||Percentage of Oxygen Saturation||95% Confidence Interval|Least Squares Mean
836969|NCT01293240|Primary|Visual Clarity|Visual clarity was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 2 weeks of wear. Visual clarity was measured on a 10-point scale, with 1 being poor and 10 being excellent.|2 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Units on a scale||Standard Deviation|Mean
836956|NCT01293006|Secondary|Mean Apnea/Hypopnea Index (AHI)|Evaluation of the effect of multiple dose administration of suvorexant on AHI as measured by polysomnography. The AHI is an overall index of obstructive sleep apnea (OSA) severity. The AHI is calculated by dividing the number of apneas and hypopneas by the number of hours of sleep. AHI values are categorized as mild OSA = 5 to <15/hr and moderate OSA = 15 to <30/hr.|Day 1 and Day 4 of each period|Twenty-four of the 25 participants were included in the primary evaluation of SaO2 and AHI data; one participant was excluded due to a protocol violation. During the Placebo periods, there were 22 evaluable participants at Day 4; 2 participants had either no data or missing data.||Events per hour||95% Confidence Interval|Least Squares Mean
836957|NCT01293006|Secondary|Percentage of Total Sleep Time in Which SaO2 is Less Than 90%, 85% or 80%|Evaluation of the percentage of the night in which SaO2 is less than 90%, less than 85% and less than 80% following multiple dose administration of suvorexant and placebo. Lower SaO2 values are associated with sleep impairment.|Day 1 and Day 4 of each period|Twenty-four of the 25 participants were included in the primary evaluation of SaO2 and AHI data; one participant was excluded due to a protocol violation. During the Placebo periods, there were 22 evaluable participants at Day 4; 2 participants had either no data or missing data.||Percentage of Total Sleep Time||95% Confidence Interval|Least Squares Mean
836958|NCT01293006|Primary|Number of Participants Discontinued From Study Drug Due to an AE|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.|Up to 15 days|All participants were included in the Safety Population.||participants|||Number
836959|NCT01293006|Primary|Number of Participants With Adverse Events|An adverse event (AE) is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.|Up to 14 days after last dose|All participants were included in the Safety Population.||participants|||Number
836960|NCT01293006|Primary|Mean Arterial Oxygen Saturation (SaO2) During Total Sleep Time|Evaluation of the effect of multiple dose suvorexant (MK-4305) on SaO2 during total sleep time as measured by pulse oximetry. Lower SaO2 values are associated with sleep impairment. Total sleep time is the total of all rapid eye movement (REM) and non-REM sleep in a sleep episode.|Day 4 of each period|Twenty-four of the 25 participants were included in the primary evaluation of SaO2 and AHI data; one participant was excluded due to a protocol violation. During the Placebo periods, there were 22 evaluable participants at Day 4; 2 participants had either no data or missing data.||Percentage of Oxygen Saturation||95% Confidence Interval|Least Squares Mean
836961|NCT01293032|Primary|The Proportion of Patients With RS 11-25 Who Refused the Assigned Treatment|The primary purpose of this trial is to determine the feasibility of carrying out a large multi-center trial with a similar design. Feasibility, in terms of less than 1/3 of patients with intermediate (11-25) Recurrence Score (RS) who refused the assigned treatment (Group 2) or refused randomization between hormonal (Arm 1) or chemotherapy (Arm 2). The confidence interval will be 95%. The proportion (and 95% confidence interval) of patients with RS 11-25 who refuse the assigned treatment will be calculated.|Up to 2 years|Patients with an intermediate RS(11-25) assigned to Group 2, Arm 1, and Arm 2 were combined in the analysis.||proportion of participants||95% Confidence Interval|Number
836962|NCT01293084|Secondary|Percent Mucociliary Clearance at 90 Minutes||90 minutes|Data for participants that completed and received both 7% saline and 0.12% saline.||percentage mucociliary clearance||Inter-Quartile Range|Median
836963|NCT01293084|Primary|Percent Mucociliary Clearance at 60 Minutes||60 minutes|Participants that completed received both 7% saline and 0.12% saline over the duration of the study||percentage mucociliary clearance||Inter-Quartile Range|Median
836964|NCT01293240|Primary|Corrected Visual Acuity|Each eye was tested individually while the participant read distant charts in normal lighting. Corrected visual acuity was measured using a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal distance eyesight. Positive logMAR values indicate poorer vision, and negative values denote better visual acuity.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.||logMAR|Participants|Standard Deviation|Mean
836965|NCT01293240|Primary|Corrected Visual Acuity|Each eye was tested individually while the participant read distant charts in normal lighting. Corrected visual acuity was measured using a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal distance eyesight. Positive logMAR values indicate poorer vision, and negative values denote better visual acuity.|2 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.||logMAR|Participants|Standard Deviation|Mean
836966|NCT01293240|Primary|Lens Deposits|Protein and lipid deposits on the contact lens surface were assessed for each eye by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the wearer’s eye. Deposits were graded on a scale of 0 to 4, with 0 being none and 4 being severe.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Units on a scale|Participants|Standard Deviation|Mean
836967|NCT01293240|Primary|Lens Deposits|Protein and lipid deposits on the contact lens surface were assessed for each eye by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the wearer’s eye. Deposits were graded on a scale of 0 to 4, with 0 being none and 4 being severe.|2 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Units on a scale|Participants|Standard Deviation|Mean
836968|NCT01293240|Primary|Visual Clarity|Visual clarity was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Visual clarity was measured on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Units on a scale||Standard Deviation|Mean
836970|NCT01293240|Primary|Ocular Redness|Ocular redness was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Ocular redness was measured on a 10-point scale, with 1 being very red and 10 being not red.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Units on a scale||Standard Deviation|Mean
836971|NCT01293240|Primary|Ocular Redness|Ocular redness was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 2 weeks of wear. Ocular redness was measured on a 10-point scale, with 1 being very red and 10 being not red.|2 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Units on a scale||Standard Deviation|Mean
836972|NCT01293240|Primary|End of Day Dryness|End of day dryness was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. End of day dryness was measured on a 10-point scale, with 1 being very dry and 10 being not dry.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Units on a scale||Standard Deviation|Mean
836973|NCT01293240|Primary|End of Day Dryness|End of day dryness was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 2 weeks of wear. End of day dryness was measured on a 10-point scale, with 1 being very dry and 10 being not dry.|2 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Units on a scale||Standard Deviation|Mean
836974|NCT01293240|Primary|Overall Comfort|Overall comfort was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Units on a scale||Standard Deviation|Mean
836975|NCT01293240|Primary|Overall Comfort|Overall comfort was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 2 weeks of wear. Overall comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent.|2 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Units on a scale||Standard Deviation|Mean
836976|NCT01293539|Primary|Number of Patients Who Complete Therapy Without the Need for Additional Treatment Including Systemic Chemotherapy, External Beam Radiation, or Enucleation.|The primary objective of this study is to show that intra-arterial delivery of the chemotherapeutic agent is successful in treating intraocular retinoblastoma, defined as avoiding systemic chemotherapy, external beam radiation, and enucleation.|Within the first six months after the initial treatment.|||Participants|||Count of Participants
836977|NCT01293695|Primary|Hot Flash Related Daily Interference Scale (HFRDIS)|This questionnaire is used to measure the effects of hot flashes on women as they go about their daily activities. Answers on the scale can range 0 (Do Not Interfere) to 10 (Completely Interfere). The total score was computed by averaging the subjective ratings over the 10 items. A lower score indicates better outcome.|6 Weeks and 12 Weeks|||units on a scale||Standard Deviation|Mean
836978|NCT01293695|Secondary|Pittsburg Sleep Quality Index (PSQI)|The Pittsburg Sleep Quality Index (PSQI) is a self-report inventory designed to measure sleep quality. The participants self rate their sleep quality over seven areas of sleep.The questions about sleep quality are answered on a 0-3 scale with higher scores indicating greater sleep pathology. The global score is determined by summing the raw scores of the seven sleep components. The global score can range from 0 - 21 and total scores above 5 are normally considered indicative of poor sleep quality.|6 Weeks and 12 Weeks|||units on a scale||Standard Deviation|Mean
836979|NCT01293695|Secondary|Sternal Skin Conductance Monitor Used to Physiologically Measure Skin Moisture|As a secondary outcome, hot flashes were measured using a Biolog ambulatory recorder. Skin conductance was expressed in micro Siemens (0 to infinity) and the final value was obtained by averaging the recorded skin conductance for a period of 24 hours. Lower skin conductance measure indicates less sweating.|6 Weeks and 12 Weeks|Analysis was conducted on all available physiological data to determine hot flash frequency. Data was missing for 29 participants in the hypnosis group and 17 participants in the structured attention group.||Micro Siemens||Standard Deviation|Mean
836980|NCT01293695|Primary|Hot Flash Score|"Hot Flash Score is a product of frequency of hot flashes × severity of hot flashes, which could range from 0 (best possible outcome) to infinity (worst possible outcome).
Hot flash frequency and hot flash severity were obtained using the Hot Flash Symptoms Diary. Participants recorded their daily hot flashes marking each hot flash (frequency) and rating the severity of each as mild (1), moderate (2), severe (3), and very severe (4).
The values presented represent the average of daily hot flash scores."|6 Weeks and 12 Weeks|||units on a scale||Standard Deviation|Mean
836981|NCT01293695|Primary|Hot Flash Frequency|The Hot Flash Symptoms Diary was used to measure hot flash frequency. Participants recorded their hot flashes over seven days by daily frequency and severity. This instrument provides a measure of hot flash frequency and hot flash score (product of frequency x severity).|6 Weeks and 12 Weeks|||hot flashes per week||Standard Deviation|Mean
836982|NCT01302054|Secondary|Percentage of Participants With No UUI Episodes (Diary Dry Rate)|UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS range from 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Week 4, Week 12|FAS: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Missing data were imputed by LOCF. N (number of participants analyzed): participants with baseline UUI episodes >0 per 24 hours and non-missing change from baseline at Week 4 and 12 (LOCF).||percentage of participants|||Number
837022|NCT01302691|Secondary|Change in Mean Trough Sitting Systolic Blood Pressure (SiSBP)|Sitting systolic blood pressure was measured by automated sphygmomanometer pre-dose on Day 1 (baseline) and at 24 ± 2 hours after the last study drug administration at Week 8. The difference between the baseline and Week 8 assessments was calculated and summarized by treatment arm.|Baseline and Week 8|All participants that received at least one dose of study treatment, had at least 1 post-randomization observation for the analysis endpoint, and had baseline data||mmHg||95% Confidence Interval|Least Squares Mean
836983|NCT01302054|Secondary|Percentage of Participants With More Than (>) 50 Percent (%) Reduction in UUI Episodes at Week 12 as Compared to Baseline|UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS range from 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Week 12|FAS: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Missing data were imputed by LOCF. N (number of participants analyzed): participants with baseline UUI episodes >0 per 24 hours and non-missing change from baseline at Week 12 (LOCF).||percentage of participants|||Number
836984|NCT01302054|Secondary|Percentage of Participants With More Than (>) 50 Percent (%) Reduction in UUI Episodes at Week 12 as Compared to Week -2|UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS range from 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Week -2, Week 12|FAS: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Missing data were imputed by LOCF. N (number of participants analyzed): participants with Week -2 UUI episodes >0 per 24 hours and non-missing change from baseline at Week 12 (LOCF).||percentage of participants|||Number
836985|NCT01302054|Secondary|Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total HRQL Score of Overactive Bladder Questionnaire (OAB-q) at Week 12|OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (not at all) to 6 (a very great deal). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.|Baseline, Week 12|FAS: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Here 'N' (number of participants analyzed): participants with non-missing change from baseline value at Week 12.||units on a scale||Standard Deviation|Mean
836986|NCT01302054|Secondary|Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 12|OAB-q: a self-administered, 33-item, questionnaire that assesses how much the participant has been bothered by selected bladder symptoms. Each item rated by participant on Likert scale 1 (not at all) to 6 (a very great deal). Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score – lowest possible value of raw score)/range]*100. Higher scores values indicative of greater symptom bother. Change=observation minus baseline.|Baseline, Week 12|FAS: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Here 'N' (number of participants analyzed): participants with non-missing change from baseline value at Week 12.||units on a scale||Standard Deviation|Mean
836987|NCT01302054|Secondary|Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) at Week 12|UPS: single-item, self-administered validated questionnaire. Participant answered: “Which of the following would typically describe your experience when you have a desire to urinate?” on a 3-point scale, 1=usually not able to hold urine; 2=usually able to hold urine (without leaking) until I reach a toilet if I go to the toilet immediately; 3= usually able to finish what I am doing before going to the toilet (without leaking). Change = observation minus baseline. Results categorized as Deterioration (Negative change); no change (Score change=0); improvement (Positive change).|Baseline, Week 12|FAS: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Here, 'N' (number of participants analyzed): participants with non-missing change from baseline value at Week 12.||participants|||Number
836988|NCT01302054|Secondary|Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12|"PPBC: single-item, self-administered validated questionnaire. Participant answered: “Which of the following statements describes your bladder condition best at the moment? on a 6-point scale, 1=no problems at all; 2=some very minor problems; 3=some minor problems; 4=some moderate problems; 5=severe problems; 6=many severe problems. Change=observation minus baseline. Results categorized as Deterioration (Positive change from baseline); No Change (scores change=0); Minor Improvement (negative score change in magnitude of 1); Major Improvement (negative score change in magnitude of >=2)."|Baseline, Week 12|FAS: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Here, 'N' (number of participants analyzed): participants with non-missing change from baseline value at Week 12.||participants|||Number
836989|NCT01302054|Secondary|Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 12|The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to 3 divided by the total number of days that diary data was collected at that visit. USS range from 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Week 12|FAS: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Missing data were imputed by LOCF. Here ‘N’ (number of participants analyzed): participants with baseline urgency episodes >0 per 24 hours and non-missing change from baseline at Week 12 (LOCF).||episodes per 24 hours||Standard Deviation|Mean
836990|NCT01302054|Secondary|Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12|Micturitions include episodes of voluntary micturition and episodes of Urgency Urinary Incontinence (UUI). UUI episodes were defined as those micturitions with USS rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine.|Baseline, Week 12|FAS: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Missing data were imputed by LOCF. Here ‘N’ (number of participants analyzed): participants with baseline micturitions >0 per 24 hours and non-missing change from baseline at Week 12 (LOCF).||micturitions per 24 hours||Standard Deviation|Mean
837732|NCT01308476|Secondary|Physicians Assessment of Usefulness of the SMS System|Only physicians of patients in the SMS reminder group were asked to assess the usefulness of the SMS system by the categories very helpful, helpful and not helpful.|Visit 2 (12 weeks) and visit 3 (24 weeks)|FAS for SMS reminder group only||Percentage of participants|||Number
836991|NCT01302054|Primary|Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12|UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS range from 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Week 12|Full Analysis set (FAS): all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Missing data were imputed by LOCF. N (number of participants analyzed): participants with baseline UUI episodes >0 per 24 hours and non-missing change from baseline at Week 12 (LOCF).||episodes per 24 hours||Standard Deviation|Mean
836992|NCT01302054|Primary|Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours|UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS range from 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Week 12|Full analysis set:all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Last Observation Carried Forward(LOCF) was used. N(number of participants analyzed):participants with baseline UUI episodes >0 per 24 hours and non-missing change from baseline at Week 12(LOCF).||episodes per 24 hours||Standard Deviation|Mean
836993|NCT01302067|Secondary|Percentage of Participants Who Became Dry at Week 12.|Percentage of participants with no UUI episode for the three day diary, the numerator being the number of participants with no UUI at a visit and the denominator the total number of participants with UUI >0 at baseline. UUI episodes defined as those with USS rating of 5 (unable to hold; leak urine) in the diary.|Week 12|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. Number of participants with Baseline UUI >0 per 24 hours and non-missing change from baseline to Week 12.||Percentage of participants|||Number
836994|NCT01302067|Secondary|Percentage of Participants Who Became Dry at Week 4.|Percentage of participants with no UUI episode for the three day diary, the numerator being the number of participants with no UUI at a visit and the denominator the total number of participants with UUI>0 at baseline. UUI episodes defined as those with USS rating of 5 (unable to hold; leak urine) in the diary|Week 4|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with baseline UUI >0 per 24 hours and non-missing change from baseline to Week 4.||Percentage of participants|||Number
836995|NCT01302067|Secondary|Change From Baseline in Health Related Quality of Life (HRQL)-Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12.|OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (not at all) to 6 (a very great deal). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.|Week 12|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with non-missing change from BL value at Week 12.||Scores on a scale||Standard Error|Least Squares Mean
836996|NCT01302067|Secondary|Change From Baseline in Health Related Quality of Life (HRQL)-Social Interaction Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12.|OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (not at all) to 6 (a very great deal). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.|Week 12|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with non-missing change from BL value at Week 12.||Scores on a scale||Standard Error|Least Squares Mean
836997|NCT01302067|Secondary|Change From Baseline in Health Related Quality of Life (HRQL)-Sleep Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12.|OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (not at all) to 6 (a very great deal). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.|Week 12|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with non-missing change from BL value at Week 12.||Scores on a scale||Standard Error|Least Squares Mean
836998|NCT01302067|Secondary|Change From Baseline in Health Related Quality of Life (HRQL)-Concern Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12.|OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (not at all) to 6 (a very great deal). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.|Week 12|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with non-missing change from BL value at Week 12.||Scores on a scale||Standard Error|Least Squares Mean
837007|NCT01302067|Secondary|Change From Baseline in Percentage of UUI Episodes Per 24 Hours at Week 12.|UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Week 12|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. LOCF was used to impute missing data at Week 12. The analysis included participants with BL UUI >0 per 24 hours and non-missing change from BL to Week 12.||Episodes per 24 hours||Full Range|Median
836999|NCT01302067|Secondary|Change From Baseline in Health Related Quality of Life (HRQL)-Coping Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12.|OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (not at all) to 6 (a very great deal). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.|Week 12|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with non-missing change from BL value at Week 12.||Scores on a scale||Standard Error|Least Squares Mean
837000|NCT01302067|Secondary|Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 12.|OAB-q: a self-administered, 33-item, questionnaire that assesses how much the participant has been bothered by selected bladder symptoms. Each item rated by participant on Likert scale 1 (not at all) to 6 (a very great deal). Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score – lowest possible value of raw score)/range]*100. Higher scores values indicative of greater symptom bother.|Week 12|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with non-missing change from baseline value at Week 12.||Scores on a scale||Standard Error|Least Squares Mean
837001|NCT01302067|Secondary|Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) at Week 12.|UPS: single-item, self-administered validated questionnaire. Participant answered: “Which of the following would typically describe your experience when you have a desire to urinate?” on a 3-point scale, 1=usually not able to hold urine; 2=usually able to hold urine (without leaking) until I reach a toilet if I go to the toilet immediately; 3= usually able to finish what I am doing before going to the toilet (without leaking). Change = observation minus baseline. Results categorized as Deterioration (Negative change); no change (Score change=0); improvement (Positive change).|Week 12|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with non-missing change from baseline value at Week 12.||Participants|||Number
837002|NCT01302067|Secondary|Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12.|PPBC: a self-administered, single-item, questionnaire that asks participants to describe their perception of their bladder-related problems. The PPBC assessment is rated on a 6-point scale: 1=no problems at all, 2=some very minor problems, 3=some minor problems, 4=moderate problems, 5=severe problems, 6=many severe problems. Improvement is defined as negative change from baseline.|Week 12|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with non-missing change from baseline value at Week 12.||Participants|||Number
837003|NCT01302067|Secondary|Change From Baseline in Percentage of Micturition-Related Urgency Episodes Per 24 Hours at Week 12.|The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to (>=) 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Week 12|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. LOCF was used to impute missing data at Week 12. The analysis included participants with BL Micturition-Related Urgency Episodes >0 per 24 hours and non-missing change from BL to Week 12.||Participant||Full Range|Median
837004|NCT01302067|Secondary|Change From Baseline in Percentage of Micturition-Related Urgency Episodes Per 24 Hours at Week 4.|The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to (>=) 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Week 4|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with BL Micturition-Related Urgency Episodes >0 per 24 hours and non-missing change from BL to Week 4.||Participant||Full Range|Median
837005|NCT01302067|Secondary|Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 12.|The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to (>=) 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Week 12|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. LOCF was used to impute missing data at Week 12. The analysis included participants with BL Micturition-Related Urgency Episodes >0 per 24 hours and non-missing change from BL to Week 12.||Episodes per 24 hours||Standard Error|Least Squares Mean
837006|NCT01302067|Secondary|Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 4.|The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to (>=) 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Week 4|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with BL Micturition-related urgency episodes >0 per 24 hours and non-missing change from BL to Week 4.||Episodes per 24 hours||Standard Error|Least Squares Mean
837100|NCT01303380|Secondary|Number of Participants Who Flared at Month 6, Month 24 and Month 36|A flare was defined as Physician Global Assessment of HIDS flare severity score of ≥ 2 and a CRP value > 10 mg/L.|Baseline, Month 6 (End of treatment period), Month 24 (End of Long term treatment period 1) and Month 36 (End of Long term treatment period 2)|The analysis was performed in the FAS population.||Number of participants|||Number
837008|NCT01302067|Secondary|Change From Baseline in Percentage of UUI Episodes Per 24 Hours at Week 4.|UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Week 4|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with BL UUI >0 per 24 hours and non-missing change from BL to Week 4.||Episodes per 24 hours||Full Range|Median
837009|NCT01302067|Secondary|Change From Baseline in Mean Number of UUI Episodes Per 24 Hours at Week 4.|UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Week 4|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with BL UUI >0 per 24 hours and non-missing change from BL to Week 4.||Episodes per 24 hours||Standard Error|Least Squares Mean
837010|NCT01302067|Secondary|Change From Baseline in Percentage of Micturitions Per 24 Hours at Week 12.|Micturitions include episodes of voluntary micturition and episodes of UUI.|Week 12|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. LOCF was used to impute missing data at Week 12. The analysis included participants with BL Micturition Frequency >0 per 24 hours and non-missing change from BL to Week 12.||Episodes per 24 hours||Full Range|Median
837011|NCT01302067|Secondary|Change From Baseline in Percentage of Micturitions Per 24 Hours at Week 4.|Micturitions include episodes of voluntary micturition and episodes of UUI.|Week 4|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with BL Micturition Frequency >0 per 24 hours and non-missing change from BL to Week 4.||Episodes per 24 hours||Full Range|Median
837012|NCT01302067|Secondary|Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12.|Micturitions include episodes of voluntary micturition and episodes of UUI.|Week 12|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. LOCF was used to impute missing data at Week 12. The analysis included participants with BL Micturition Frequency >0 per 24 hours and non-missing change from BL to Week 12.||Episodes per 24 hours||Standard Error|Least Squares Mean
837013|NCT01302067|Secondary|Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4.|Micturitions include episodes of voluntary micturition and episodes of UUI.|Week 4|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with BL Micturition Frequency >0 per 24 hours and non-missing change from BL to Week 4.||Episodes per 24 hours||Standard Error|Least Squares Mean
837014|NCT01302067|Primary|Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12.|UUI episodes were defined as those with the Urinary Sensation Scale (USS) rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Week 12|Full Analysis Set (FAS)included participants receiving 1 dose of assigned study drug and with 1 baseline (BL) or post-BL efficacy assessment. Last observation carried forward (LOCF) was used to impute missing data at Week 12. Participants with baseline UUI >0 per 24 hours & non-missing change from BL to Week 12 were included.||Episodes per 24 hours||Standard Error|Least Squares Mean
837015|NCT01302119|Secondary|Negative Mycology of Target Great Toenail at Week 52|Negative KOH and negative fungal culture.|Week 52|Efficacy analysis was performed using the ITT population. The LOCF was used in order to provide a value for efficacy parameters that were missing.||participants|||Number
837016|NCT01302119|Secondary|Treatment Success (Completely Clear or Almost Clear Nail and Negative Mycology) of Target Great Toenail at Week 52|No clinical evidence of onychomycosis as evidenced by normal toenail plate, no onycholysis, and no subungual hyperkeratosis, or no more than minimal evidence of onychomycosis as evidenced by toenail plate dystrophic or discolored over ≤ 10% of the distal aspect, with minimally evident onycholysis and subungual hyperkeratosis, and negative KOH wet mount and negative fungal culture.|Week 52|Efficacy analysis was performed using the ITT population. The LOCF was used in order to provide a value for efficacy parameters that were missing.||participants|||Number
837017|NCT01302119|Secondary|Completely Clear or Almost Clear Target Great Toenail at Week 52|No clinical evidence of onychomycosis as evidenced by normal toenail plate, no onycholysis, and no subungual hyperkeratosis, or no more than minimal evidence of onychomycosis as evidenced by toenail plate dystrophic or discolored over ≤ 10% of the distal aspect, with minimally evident onycholysis and subungual hyperkeratosis.|Week 52|Efficacy analysis was performed using the ITT population. The LOCF was used in order to provide a value for efficacy parameters that were missing.||participants|||Number
837018|NCT01302119|Primary|Complete Cure (Completely Clear Nail and Negative Mycology) of Target Great Toenail at Week 52|No clinical evidence of onychomycosis as evidenced by normal toenail plate, no onycholysis, and no subungual hyperkeratosis, and negative KOH wet mount and negative fungal culture.|Week 52|Efficacy analysis was performed using the ITT population. The last observation was carried forward (LOCF) in order to provide a value for efficacy parameters that were missing.||participants|||Number
837019|NCT01302366|Primary|Duration of Response (Excluding Patient Choice and Non-compliance)|Response [complete response (CR), partial response (PR), and stable disease (SD)] was assessed after approximately 2 months, 6 months and then every 4 months, until progression of disease. Response and progression of disease evaluation is based on the criteria reported by Blade, et al. (1998).|up to 3 years|All patients or the patients excluding personal choice or non-compliance||months||Full Range|Median
837020|NCT01302366|Secondary|Percentage of Patients Who Have Responded to TBL12|Response to TBL12 is defined as SD or better after 2 cycles of TBL12. The evaluation of SD, PR, or CR is based on the report by Blade et al. (1998)|2 months|all patients||percentage of participants|||Number
837021|NCT01302366|Primary|Duration of Response (All Treated Patients)|Response [complete response (CR), partial response (PR), and stable disease (SD)] was assessed after approximately 2 months, 6 months and then every 4 months, until progression of disease. Response and progression of disease evaluation is based on the criteria reported by Blade, et al. (1998).|up to 3 years|||months||Full Range|Median
837023|NCT01302691|Primary|Percentage of Participants Who Had Study Drug Stopped Due to an AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants who had study drug stopped during the 8-week treatment period due to an AE regardless of whether or not they completed the study was summarized by treatment arm|up to 8 weeks|All randomized participants who received at least 1 dose of study drug.||Percentage of Participants|||Number
837024|NCT01302691|Primary|Percentage of Participants Who Experience ≥1 Drug-related SAE|An SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. Percentage of participants that experienced at least 1 SAE that was reported as possibly, probably, or definitely related to the study drug by the investigator during the 10-week treatment and follow-up period were summarized by study drug received|up to 14 days after last dose of study drug (up to 10 weeks)|All randomized participants who received at least 1 dose of study drug.||Percentage of Participants|||Number
837025|NCT01302691|Primary|Percentage of Participants Who Experience ≥1 Serious Adverse Event (SAE)|An SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. The percentage of participants who experienced at least 1 SAE during the 10-week treatment and follow-up period were summarized by study drug received.|up to 14 days after last dose of study drug (up to 10 weeks)|All randomized participants who received at least 1 dose of study drug.||Percentage of Participants|||Number
837026|NCT01302691|Primary|Percentage of Participants Who Experience ≥1 Drug-related AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. Percentage of participants that experienced at least 1 AE that was reported as possibly, probably, or definitely related to the study drug by the investigator during the 10-week treatment and follow-up period were summarized by study drug received.|up to 14 days after last dose of study drug (up to 10 weeks)|All randomized participants who received at least 1 dose of study drug.||Percentage of Participants|||Number
837027|NCT01302691|Primary|Percentage of Participants Who Experience ≥1 Adverse Event (AE)|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants who experienced at least 1 AE during the 10-week treatment and follow-up period were summarized by study drug received.|up to 14 days after last dose of study drug (up to 10 weeks)|All randomized participants who received at least 1 dose of study drug.||Percentage of Participants|||Number
837028|NCT01302691|Primary|Change in Mean Trough Sitting Diastolic Blood Pressure (SiDBP)|Sitting diastolic blood pressure was measured by automated sphygmomanometer pre-dose on Day 1 (baseline) and at 24 ± 2 hours after the last study drug administration at Week 8. The difference between the baseline and Week 8 assessments was calculated and summarized by treatment arm.|Baseline and Week 8|All participants that received at least one dose of study treatment, had at least 1 post-randomization observation for the analysis endpoint, and had baseline data||mmHg||95% Confidence Interval|Least Squares Mean
837029|NCT01302743|Primary|Decrease in LDL Cholesterol|Subjects will have baseline blood levels to measure LDL Cholesterol. Subjects will then take either cinnamon bark powder, water-soluble cinnamon extract or metformin for 90 days then blood levels of HbA1c and lipid panel will be drawn again.|90 days|no data was analyzed as study was stopped early due to low recruitment|||||
837030|NCT01302743|Primary|Decrease in HbA1c|Subjects will have baseline blood levels to measure HbA1c. Subjects will then take either cinnamon bark powder, water-soluble cinnamon extract or metformin for 90 days then blood levels of HbA1c and lipid panel will be drawn again.|90 days|no data was analyzed as study was stopped early due to low recruitment|||||
837031|NCT01302860|Secondary|Number of Participants With Anti-canakinumab Antibodies at Week 56|Immunogenicity assessment included determination of anti-canakinumab (ACZ885) antibodies in serum samples using BIAcore system, with detection based on surface plasmon resonance technique.|Week 56 (End of study)|The analysis was performed in the safety set population. Here, ‘Number of participants analysed’ signifies participants who had immunogenicity samples taken and analyzed during the study.||participants|||Number
837032|NCT01302860|Secondary|Number of Vaccination Cases With Protective Antibody Levels Following Immunization With Inactivated Vaccines|Participants who received any inactivated vaccines during the study were assessed for their ability to attain protective antibody levels against the vaccine (antigen) post immunization. Participants vaccinations were not assessed for a response if the antibody titre was already sufficient at pre-dose and maintained during the study.|Day -14 (prior-vaccination), Day 0 (vaccination), Day 28, Day 57 (post-vaccination)|"The analysis was performed in the FAS population. Here, Number of participants analysed signifies evaluable participants who received a total of 31 vaccinations during the study."||vaccination cases|||Number
837033|NCT01302860|Secondary|Percentage of Participants Receiving a Concomitant Vaccination During the Study|Participants received any one of the following inactivated vaccines as per the immunization program: Corynebacterium diphtheria, Bordetella pertussis, Neisseria meningitidis, Clostridium tetani, Influenza type A, Influenza type B, Haemophilus influenza B, Streptococcus pneumoniae, or Hepatitis B were determined.|Day 1 (start of study treatment) to Week 56 (end of study)|The analysis was performed in the FAS population.||Percentage of participants|||Number
837034|NCT01302860|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Adverse events (AEs) were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events (SAEs) were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards.|Day 1 (start of study treatment) up to Week 56 (end of study)|The analysis was performed in the safety set population defined as participants who received at least one dose of study drug. Here, ‘n’ signifies participants evaluable for this measure at specified time points for each group, respectively.||participants|||Number
837035|NCT01302860|Secondary|Change From Baseline in C­-Reactive Protein (CRP) and Serum Amyloid A (SAA) Concentrations at Week 56|The CRP and SAA were used as inflammatory markers. The target level concentrations for CRP and SAA was ≤15 mg/L and ≤10 mg/L, respectively. Negative change in concentration of inflammatory markers indicated improvement.|Baseline, Week 56|The analysis was performed in FAS population. Here ‘n’ signifies those participants with evaluable measurements at both baseline and the post-baseline visit.||mg/L||Standard Deviation|Mean
837036|NCT01302860|Secondary|Percentage of Participants With Defined Grades in Physician Assessment of Skin Disease at Week 56|Participants were assessed by physician for skin disease (urticarial skin rash) measured on a 5-­point scale as: 0 = None/absent; 1 = Minimal; 2 = Mild; 3 = Moderate; 4 = Severe.|Week 56|The analysis was performed in FAS population.||Percentage of participants|||Number
837037|NCT01302860|Secondary|Percentage of Participants With Defined Grades in Physician’s Global Assessment Score at Week 56|Participants were assessed based by physician on Physician's Global Assessment measured on a 5­-point scale for auto inflammatory disease activity as: 0 = None/absent; 1 = Minimal; 2 = Mild; 3 = Moderate; 4 = Severe.|Week 56|The analysis was performed in FAS population.||Percentage of participants|||Number
837038|NCT01302860|Secondary|Percentage of Participants Aged 2 Years or Younger With at Least One Complete Response at Week 56|Complete response was defined as clinical remission and serological remission. Clinical remission was defined as Physician global assessment of auto-inflammatory disease activity as absent or minimal (using a 5-point scale ranging from absent to severe) and assessment of skin disease as absent or minimal (using a 5-point scale ranging from absent to severe). Serological remission was defined as CRP or SAA to be <15 mg/L and <10 mg/L respectively.|Week 56|"The analysis was performed in FAS population. Here, Number of participants analysed signifies participants aged 2 years or younger."||Percentage of participants|||Number
837039|NCT01302860|Primary|Percentage of Participants Aged 4 Years or Younger With at Least One Complete Response at Week 56|Complete response was defined as clinical remission and serological remission. Clinical remission was defined as Physician global assessment of auto-inflammatory disease activity as absent or minimal (using a 5-point scale ranging from absent to severe) and assessment of skin disease as absent or minimal (using a 5-point scale ranging from absent to severe). Serological remission was defined as C reactive protein (CRP) or Serum amyloid A protein (SAA) to be less than (<) 15 milligram per liter (mg/L) and <10 mg/L respectively.|Week 56|The analysis was performed in Full analysis set (FAS), defined as all participants who received at least one dose of study drug under this study protocol.||Percentage of participants|||Number
837040|NCT01302899|Secondary|Number of Participants With Adverse Events, Serious Adverse Events and Death as Assessment of Safety and Tolerability of Aliskiren Added to Ramipril||26 weeks|The safety analysis set consisted of all patients who received at least one study drug and had no major protocol deviations that could have impacted safety data.||Participants|||Number
837041|NCT01302899|Secondary|Plasma Rennin Concentration (PRC)|Blood biomarkers were obtained from blood samples in all patients at the time points such as baseline, week 6, week 12, week 18 and week 26. PRC measures the concentration of immunoactive renin in the plasma.|Baseline to week 26|The study was terminated and consequentially was underpowered for adequate statistical analysis|||||
837042|NCT01302899|Secondary|Plasma Rennin Activity (PRA)|Blood biomarkers were obtained from blood samples in all patients at the time points such as baseline, week 6, week 12, week 18 and week 26. Plasma PRA is a direct measure of the formation of Ang I in the plasma.|Baseline to week 26|The study was terminated and consequentially was underpowered for adequate statistical analysis|||||
837043|NCT01302899|Secondary|Mean Extracellular Volume (ECV) as One of Hemodynamic Assessments||26 weeks|The study was terminated and consequentially was underpowered for adequate statistical analysis|||||
837044|NCT01302899|Secondary|Percentage of Renal Filtration Fraction (RFF) as One of Hemodynamic Assessments||26 weeks|The study was terminated and consequentially was underpowered for adequate statistical analysis|||||
837045|NCT01302899|Secondary|Mean Effective Renal Plasma Flow (ERPF) as One of Hemodynamic Assessments||26 weeks|The study was terminated and consequentially was underpowered for adequate statistical analysis|||||
837046|NCT01302899|Secondary|Mean Glomerular Filtration Rate (GFR) as Measurement of Renal Function|All patients had to visit the main center for renal function measurements. The measurements were performed using the constant infusion method with I-iothalamate (IOT) and I-hippuran. GFR was calculated as the urinary clearance of IOT.|26 weeks|The study was terminated and consequentially was underpowered for adequate statistical analysis|||||
837047|NCT01302899|Secondary|Mean Sitting Diastolic Blood Pressure (msDBP)|At study entry, blood pressure (BP) was measured in both arms. If there was a clinically relevant difference in readings between arms (≥ 10 mmHg in systolic BP and/or ≥ 5 mmHg in diastolic BP), the arm with higher BP reading was used. If there was no clinically significant difference between arms, the non-dominant arm was used through out study. Diastolic blood pressure were assessed after the patient rested quietly in the sitting position for at least 3 minutes. For each sitting assessment, blood pressure was assessed at least 3 times. From these assessments, msDBP was calculated. All BP measurements were to be performed on the same arm.|26 weeks|The study was terminated and consequentially was underpowered for adequate statistical analysis|||||
837101|NCT01303380|Secondary|Number of Flares Per Participant at During Treatment Period and 24 Month Extension Period|A flare was defined as Physician Global Assessment of HIDS flare severity score of ≥ 2 and a CRP value > 10 mg/L.|Month 6 (End of treatment period), Month 36 (End of Long term treatment Period 2)|The analysis was performed in the FAS population.||Number of flares||Full Range|Median
837048|NCT01302899|Secondary|Mean Sitting Systolic Blood Pressure (msSBP)|At study entry, blood pressure (BP) was measured in both arms. If there was a clinically relevant difference in readings between arms (≥ 10 mmHg in systolic BP and/or ≥ 5 mmHg in diastolic BP), the arm with higher BP reading was used. If there was no clinically significant difference between arms, the non-dominant arm was used through out study. Systolic blood pressure were assessed after the patient rested quietly in the sitting position for at least 3 minutes. For each sitting assessment, blood pressure was assessed at least 3 times. From these assessments, msSBP was calculated. All BP measurements were to be performed on the same arm.|26 weeks|The study was terminated and consequentially was underpowered for adequate statistical analysis|||||
837049|NCT01302899|Primary|Effect of Aliskiren on Albuminuria as Measured by Creatinine Indexed Albumin|Two 24-hour collections of urine were to be made at each study visit. The arithmetic mean of the two collections were planned to be used in the calculation of summary statistics and the statistical analyses.|26 weeks|The study was terminated and consequentially was underpowered for adequate statistical analysis|||||
837050|NCT01302899|Primary|Effect of Aliskiren on Albuminuria as Measured by Urinary Albumin Excretion Rate (UAER)|Two 24-hour collections of urine were to be made at each study visit. The arithmetic mean of the two collections were planned to be used in the calculation of summary statistics and the statistical analyses.|26 weeks|The study was terminated and consequentially was underpowered for adequate statistical analysis|||||
837051|NCT01302938|Other Pre-specified|Number of Participants With Laboratory Abnormalities|Criteria for potentially clinically significant (PCS) laboratory values: Hemoglobin, hematocrit, red blood cell less than (<) 0.8 lower limit of normal(LLN); platelet <0.5 LLN, >1.75 upper LN (ULN);white blood cell <0.6 LLN, >1.5 ULN; lymphocyte, total neutrophil(absolute[AL]),Total protein, albumin, phosphate <0.8 LLN, >1.2 ULN; basophil, eosinophil, monocyte >1.2ULN; Total bilirubin >1.5ULN; aspartate, alanine aminotransferase, alkaline phosphatase >3ULN; Blood urea nitrogen, creatinine >1.3ULN; sodium <0.95LLN, >1.05ULN; potassium, chloride, bicarbonate, calcium <0.9LLN, >1.1ULN.|Week 12|Safety set included all participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||participants|||Number
837052|NCT01302938|Other Pre-specified|Number of Participants Who Discontinued the Study Due to Adverse Events|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|Baseline up to 28 days after last dose|Safety set included all participants who received at least 1 dose of study medication.||participants|||Number
837053|NCT01302938|Other Pre-specified|Number of Participants With Adverse Events (AEs) by Relatedness and Severity|AE:any untoward medical occurrence attributed to study medication in participant who received study drug. Relatedness to study medication was assessed by the investigator. Severity of AEs assessed as: mild (does not interfere with participant's usual function), moderate (interferes to some extent with participant's usual function) and severe (interferes significantly with participant's usual function). Mild, moderate and severe are not mutually exclusive; hence same participant may be included in more than 1 type of severity of AEs.|Baseline up to 28 days after last dose|Safety set included all participants who received at least 1 dose of study medication.||participants|||Number
837054|NCT01302938|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to 28 days after last dose|Safety set included all participants who received at least 1 dose of study medication.||participants|||Number
837055|NCT01302938|Secondary|Participant Perception Regarding Recommending a Friend to Enter Similar Study|PEQ is a web-based self-administered, exploratory questionnaire that assesses the participant’s perception of trial method. Number of participants who responded to question 6, “How likely would you be to recommend a friend to enter a similar study?” are reported.|Week 12|FAS included all participants who received at least 1 dose of study medication and had at least 1 baseline or post-baseline efficacy assessment. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.||participants|||Number
837056|NCT01302938|Secondary|Participant Perception Regarding Received Treatment in the Study|PEQ is a web-based self-administered, exploratory questionnaire that assesses the participant’s perception of trial method. Number of participants who responded to question 5, “What treatment did you think you were on?” are reported.|Week 12|FAS included all participants who received at least 1 dose of study medication and had at least 1 baseline or post-baseline efficacy assessment. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.||participants|||Number
837057|NCT01302938|Secondary|Participant Perception Regarding Cell Phone Diary|PEQ:self-administered, assesses participants perception of trial method. Question4, “How satisfied were you with items?” on scale 1(very easy) to 5(very difficult)- a: teaching video explaining CP use; recording urinations using CP; size of text on CP; sending your urinary information(inf) using your CP, e: overall, suitability for capturing urinations as they happened.|Week 12|FAS included all participants who received at least 1 dose of study medication and had at least 1 baseline or post-baseline efficacy assessment. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.||participants|||Number
837058|NCT01302938|Secondary|Participant Perception Regarding Satisfaction Related to Study|PEQ:self-administered, to assess perception of trial method. Question3, “How satisfied were you with items?” on scale 1(very satisfied) to 5(very dissatisfied)- recruitment; questionnaires,surveys(Ques,Sur); identification verification(IV); informed consent(IC) process; website experience; phone call; laboratory(lab) kit delivery; lab location; lab staff service(Ser); physical exam(PE) scheduling,location (sch,loc); PE visit; medication(med) first batch delivery; med second batch delivery; cell phone(CP) received; CP use; call center(CC) ser; medical support(supp); technical supp; overall.|Week 12|FAS included all participants who received at least 1 dose of study medication and had at least 1 baseline or post-baseline efficacy assessment. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.||participants|||Number
837059|NCT01302938|Secondary|Number of Participants With Reason for Participation in the Study|PEQ is a web-based self-administered, exploratory questionnaire that assesses the participant’s perception of trial method. Number of participants who responded to question 2, “What led you to participate given the study drug is already available?” are reported.|Week 12|FAS included all participants who received at least 1 dose of study medication and had at least 1 baseline or post-baseline efficacy assessment. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.||participants|||Number
837060|NCT01302938|Secondary|Number of Participants With Response Regarding Source of First Information About Study|Participant experience questionnaire (PEQ) is a web-based self-administered, exploratory questionnaire that assesses the participant’s perception of trial method. Number of participants who responded to question 1, “Where did you hear first about the study?” are reported.|Week 12|FAS included all participants who received at least 1 dose of study medication and had at least 1 baseline or post-baseline efficacy assessment. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.||participants|||Number
837061|NCT01302938|Secondary|Change From Baseline in Health Related Quality of Life (HRQL) Social Domain Score at Week 12|OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (not at all) to 6 (a very great deal). Questions 9 to 33 constitute HRQL, includes domains (range): concern(7-42), coping(8-48), sleep(5-30), and social function(5-30). Total HRQL score (25-125) derived as sum of HRQL domains. Transformed score range 0 to 100 (HRQL domain or total) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicate better HRQL.|Baseline, Week 12|FAS included all participants who received at least 1 dose of study medication and had at least 1 baseline or post-baseline efficacy assessment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Full Range|Median
837062|NCT01302938|Secondary|Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12|OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (not at all) to 6 (a very great deal). Questions 9 to 33 constitute HRQL, includes domains (range): concern(7-42), coping(8-48), sleep(5-30), and social function(5-30). Total HRQL score (25-125) derived as sum of HRQL domains. Transformed score range 0 to 100 (HRQL domain or total) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicate better HRQL.|Baseline, Week 12|FAS included all participants who received at least 1 dose of study medication and had at least 1 baseline or post-baseline efficacy assessment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
837063|NCT01302938|Secondary|Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 12|OAB-q: a self-administered, 33-item, questionnaire that assesses how much the participant has been bothered by selected bladder symptoms. Each item rated by participant on Likert scale 1 (not at all) to 6 (a very great deal). Symptom bother score derived as sum of scores for items 1 to 8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score - lowest possible value of raw score)/range]*100. Higher scores values indicative of greater symptom bother.|Baseline, Week 12|FAS included all participants who received at least 1 dose of study medication and had at least 1 baseline or post-baseline efficacy assessment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
837064|NCT01302938|Secondary|Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 1, 4 and 12|PPUS: a self-administered, single-item, validated questionnaire that measures the participant’s perception of urinary urgency. It is sensitive to changes in perceptions of urinary urgency over time. Scale of 0 (usually not able to hold urine), 1 (usually able to hold urine [without leaking] until reaching toilet if go to toilet immediately), or 2 (usually able to finish what he/she is doing before going to toilet [without leaking]). Results categorized as SC from baseline on 3-point scale: improvement (positive SC), no change (SC 0), deterioration (negative SC).|Baseline (Bl), Week 1, 4, 12|FAS included all participants who received at least 1 dose of study medication and had at least 1 baseline or post-baseline efficacy assessment. Missing values imputed using LOCF method. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.||participants|||Number
837065|NCT01302938|Secondary|Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12|PPBC: self-administered,single-item questionnaire to describe participant’s perception of bladder-related problems. PPBC assessed on 6-point scale:1=no problems at all,2=some very minor problems,3=some minor problems,4=some moderate problems,5=severe problems,6=many severe problems. Results categorized as score change (SC) from baseline on 2-point scale:improvement (negative SC),no improvement (SC 0 or more) and on 4-point scale:major improvement (SC is negative in magnitude of 2 or more), minor improvement (SC is negative in magnitude of 1), no change (SC= 0),deterioration (positive SC).|Baseline, Week 1, 4, 12|FAS included all participants who received at least 1 dose of study medication and had at least 1 baseline or post-baseline efficacy assessment. Missing values imputed using LOCF method. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.||participants|||Number
837066|NCT01302938|Secondary|Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 1, 4 and 12|The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of >= 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. Baseline values for each time point were calculated separately considering only those participants who were evaluable at the given time point.|Baseline, Week 1, 4, 12|FAS population. Missing values imputed using LOCF method. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.||episodes per 24 hours||Standard Deviation|Mean
837259|NCT01297322|Primary|Time to Hemostasis (TTH)|Primary effectiveness endpoint - elapsed time between device (VASCADE) or sheath (manual compression) removal and first observed and confirmed arterial hemostasis.|Up to 1 hour|||minutes||Standard Deviation|Mean
837067|NCT01302938|Secondary|Change From Baseline in Mean Number of Nocturnal Micturition-Related Urgency Episodes Per 24 Hours at Week 1, 4 and 12|The mean number of micturition-related nocturnal urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to (>=) 3 that occurred between time participant went to bed and time participant arose to start next day divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Week 1, 4, 12|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis, as per change in planned analysis.|||||
837068|NCT01302938|Secondary|Change From Baseline in Mean Number of Nocturnal Micturitions Per 24 Hours at Week 1, 4 and 12|Nocturnal micturitions were defined as micturitions with USS rating 1-5 that occurred between the time the participant went to bed and the time he or she arose to start the next day. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The mean number of nocturnal micturitions per 24 hours was calculated as the total number of nocturnal micturitions divided by the total number of diary days collected at that visit.|Baseline, Week 1, 4, 12|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis, as per change in planned analysis.|||||
837069|NCT01302938|Secondary|Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 1 and 4|Micturitions include episodes of voluntary micturition and episodes of UUI. UUI episodes were defined as those micturitions with USS rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine. The mean number of micturitions per 24 hours was calculated as the total number of micturitions divided by the total number of diary days collected at that visit. Baseline values for each time point were calculated separately considering only those participants who were evaluable at the given time point.|Baseline, Week 1, 4|FAS population. Missing values imputed using LOCF method. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.||micturitions per 24 hours||Standard Deviation|Mean
837070|NCT01302938|Secondary|Change From Baseline in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 1, 4 and 12|UUI episodes were defined as those with the Urinary Sensation Scale (USS) rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. Baseline values for each time point were calculated separately considering only those participants who were evaluable at the given time point.|Baseline, Week 1, 4, 12|FAS population. Missing values imputed using LOCF method. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.||episodes per 24 hours||Full Range|Median
837071|NCT01302938|Secondary|Change From Baseline in Mean Voided Volume Per Micturition at Week 1, 4 and 12|Mean voided volume per micturition was calculated as sum of voided volume divided by the total number of micturition episodes with a recorded voided volume greater than 0 at that visit. Baseline values for each time point were calculated separately considering only those participants who were evaluable at the given time point.|Baseline, Week 1, 4, 12|FAS population. Missing values imputed using LOCF method. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.||milliliter (mL)||Standard Deviation|Mean
837072|NCT01302938|Primary|Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12|Micturitions include episodes of voluntary micturition and episodes of Urgency Urinary Incontinence (UUI). UUI episodes were defined as those micturitions with Urinary Sensation Scale (USS) rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine. The mean number of micturitions per 24 hours was calculated as the total number of micturitions divided by the total number of diary days collected at that visit.|Baseline, Week 12|Full analysis set (FAS) included all participants who received at least 1 dose of study medication and had at least 1 baseline or post-baseline efficacy assessment. Missing values imputed using Last observation carried forward (LOCF) method. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.||micturitions per 24 hours||Standard Deviation|Mean
837073|NCT01303159|Secondary|Number of Participants With Adverse Events|To assess safety of an endoscopic bipolar radiofrequency catheter (EndoHPB) in the management of unresectable cholangiocarcinoma and pancreatic cancer|2 years|Preliminary analyses because study was terminated before follow up data could be collected.||participants|||Number
837074|NCT01303159|Primary|Change From Baseline in Bile Duct Stricture Diameter|To assess effectiveness of an endoscopic bipolar radiofrequency catheter (EndoHPB) in the management of unresectable cholangiocarcinoma and pancreatic cancer|2 years|Participants not analyzed has study was terminated before follow up data could be collected.|||||
837075|NCT01303224|Other Pre-specified|Subgroup Analysis: Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort According to the 75% Rule in the Male ITT Population|"Weekly binary questions (yes/no) from IV/WRS diary records: Did you have satisfactory relief of your overall IBS symptoms during the last week? and Did you have satisfactory relief of your abdominal pain or discomfort during the last week?
Responder: Report of satisfactory overall IBS symptom relief =Yes and of satisfactory abdominal pain/discomfort relief = Yes 6/8 weeks (75% rule)"|Eight weeks|Intention-to-Treat in the male population (226)||participants|||Number
837076|NCT01303224|Other Pre-specified|Subgroup Analysis: Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort According to the 75% Rule in the Female ITT Population|"Weekly binary questions (yes/no) from IV/WRS diary records: Did you have satisfactory relief of your overall IBS symptoms during the last week? and Did you have satisfactory relief of your abdominal pain or discomfort during the last week?
Responder: Report of satisfactory overall IBS symptom relief =Yes and of satisfactory abdominal pain/discomfort relief = Yes 6/8 weeks (75% rule)"|Eight weeks|Intention-to-Treat in the female population (333)||participants|||Number
837733|NCT01308476|Secondary|Patients Assessment of Usefulness of the SMS System|Only patients in the SMS reminder group were asked to assess the usefulness of the SMS system by the categories very helpful, helpful and not helpful.|Visit 2 (12 weeks) and visit 3 (24 weeks)|FAS for SMS reminder group only||Percentage of participants|||Number
837077|NCT01303224|Secondary|Quality of Life Changes (Using EuroQoL EQ-5D Questionnaire)|Change in EQ-5D Quality of Life (visual analogue scale) score at the end of 8 weeks of treatment versus baseline (at randomisation). EQ-5D quality of life visual analogue scale ranges from “0”= worst imaginable health state to “100”=best imaginable health state.|Eight weeks|Intention-to-treat; i.e. all ITT patients who provided EQ-5D data at Visit 2 (start of treatment) and Visit 4 (end of treatment).||units on a scale||Standard Deviation|Mean
837078|NCT01303224|Secondary|Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort at the End of 8 Weeks of Treatment, Where the Response is Defined as at Least 4 Weeks With Satisfactory Relief During 8 Weeks of Treatment (50% Rule) in the ITT Population|"Weekly binary questions (yes/no) from IV/WRS diary records: Did you have satisfactory relief of your overall IBS symptoms during the last week? and Did you have satisfactory relief of your abdominal pain or discomfort during the last week?
Responder: Report of satisfactory overall IBS symptom relief =Yes and of satisfactory abdominal pain/discomfort relief = Yes 4/8 weeks with at least 2 consecutive weeks of satisfactory relief during Week 5 to Week 8(50% rule)"|Eight weeks|Intention-to-Treat (559)||participants|||Number
837079|NCT01303224|Primary|Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort at the End of 8 Weeks of Treatment, Where the Response is Defined as at Least 6 Weeks With Satisfactory Relief During 8 Weeks of Treatment (75% Rule); Intention-to-treat (ITT).|"Weekly binary questions (yes/no) from Interactive Voice/Web Response (IV/WRS) diary records: Did you have satisfactory relief of your overall IBS symptoms during the last week? and Did you have satisfactory relief of your abdominal pain or discomfort during the last week?
Responder: Report of satisfactory overall IBS symptom relief =Yes and of satisfactory abdominal pain/discomfort relief = Yes 6/8 weeks (75% rule)"|Eight weeks|Intention-to-Treat (559)||participants|||Number
837080|NCT01303380|Secondary|Number of Participants Exhibiting Anti-canakinumab Antibodies at Any Visit|Immunogenicity assessment included determination of anti-canakinumab (ACZ885) antibodies in serum samples using bridging ECLIA assay.|Baseline up to Month 36 (End of study)|The analysis was performed on the FAS population.||Number of participants|||Number
837081|NCT01303380|Secondary|Serum Concentration of Total Interleukin-1β Antibody (IL-1β)|Pharmacodynamics of canakinumab was assessed by total IL-1β (sum of free and bound canakinumab) concentration, determined in serum by means of sandwich ELISA assay with limit of detection at 0.1 picogram/millilitre.|Day 1 (Pre-dose), Day 4, Day 15, Day 43, Day 85, Day 127, Day 169 (End of treatment period), Day 197, Day 225, Day 253, Day 281, Day 309, and Day 337 (End of follow-up period) (Post-dose)|The analysis was performed on the FAS population.||picogram(s)/milliliter||Standard Deviation|Mean
837082|NCT01303380|Secondary|Serum Concentration-time Profile of Canakinumab|Canakinumab concentrations in serum were assessed for evaluating pharmacokinetics (PK) of the drug.|Day 1 (Pre-dose), Day 4, Day 15, Day 43, Day 85, Day 127, Day 169 (End of treatment period), Day 197, Day 225, Day 253, Day 281, Day 309, and Day 337 (End of follow-up period) (Post-dose)|The analysis was performed on the FAS population.||microgram(s)/milliliter||Standard Deviation|Mean
837083|NCT01303380|Secondary|Participants Who Received Rescue Treatment|Participants who experienced flares were treated with corticosteroids and NSAIDs as rescue medication.|Baseline up to Month 36 (End of study)|The analysis was performed on the FAS population.||Percentage of participants|||Number
837084|NCT01303380|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Adverse events (AEs) were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events (SAEs) were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalisation, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards.|Day 1 (Start of study treatment) up to Month 36 (End of study)|The analysis was performed on Safety Set (SAF) population defined as all participants who received at least one application of study treatment and had at least one post-baseline safety assessment.||Number of participants|||Number
837085|NCT01303380|Secondary|Time to Flare After the Last Dose of Canakinumab During the Follow-up Period|The median time to flare by the participants after administration of the last dose of canakinumab during the follow-up period was analysed using Kaplan-Meier method.|Last dose of canakinumab treatment in follow-up period to end of follow-up period (Day 337)|"The analysis was performed on the FAS population. Here Number of participants analysed signifies the participants assessed for time to flare after the last dose of canakinumab during follow-up period."||days||Full Range|Median
837086|NCT01303380|Secondary|Duration of Flares Experienced During the Study|Flare was defined as Physician Global Assessment of HIDS flare severity score of ≥ 2 and a CRP value > 10 mg/L. The change in post canakinumab treatment flare duration during the study were assessed as compared to historical period.|Baseline, Month 6 (End of treatment period), Month 12 (End of follow up period), Month 24 (End of Long term treatment period 1) and Month 36 (End of Long term treatment period 2)|The analysis was performed in the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group respectively.||Days||Full Range|Median
837087|NCT01303380|Secondary|Percentage of Participants Who Received Dose Up-titration During 6-month Treatment Period|Participants who experienced a new HIDS flare between baseline and Week 4 and received an escalated dose of 450 mg of canakinumab every 6 weeks thereafter starting at Week 6 were determined.|Day 1 up to Month 6 (End of follow up)|The analysis was performed in the FAS population.||Percentage of participants|||Number
837088|NCT01303380|Secondary|Childhood Health Assessment Questionnaire (CHAQ) Global Score in Children Over Time|Participants or their parents (participants aged 6 to 17 years) were assessed for HRQoL based on Childhood Health Assessment Questionnaire (CHAQ). CHAQ was an eight domain questionnaire representing functional capacity and independence, evaluated for previous week. Each domain was rated on a 4-point difficulty scale: 0 = any difficulty; 1 = some difficulty; 2 = much difficulty; 3 = unable to do.The total score is the mean from the 8 scores, and ranges from 0 (no disability) to 3 (completely disabled).|Baseline, Month 6 (End of treatment period), Month 12 (End of follow up period), Month 24 (End of Long term treatment period 1) and Month 36 (End of Long term treatment period 2)|"The analysis was performed in the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group respectively. Here Number of participants analyzed signifies the participants assessed for CHAQ during study."||Score on a scale||Full Range|Median
837089|NCT01303380|Secondary|Health Assessment Questionnaire (HAQ) Global Score in Adults Over Time|Participants were assessed for health-related quality of life (HRQoL) based on Health Assessment Questionnaire (HAQ). HAQ was an eight 8 categories questionnaire representing all activities related to physical function. Each category has various sub-categories, which were rated by the participants on a 4- point difficulty scale: 0 = any difficulty; 1 = some difficulty; 2 = much difficulty; 3 = unable to do. The total score was the mean of the 8 scores, and ranged from 0 (no disability) to 3 (completely disabled).|Baseline, Month 6 (End of treatment period), Month 12 (End of follow up period), Month 24 (End of Long term treatment period 1) and Month 36 (End of Long term treatment period 2)|"The analysis was performed in the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group respectively. Here Number of participants analyzed signifies the participants assessed for HAQ during study."||Score on a scale||Full Range|Median
837090|NCT01303380|Secondary|Change From Baseline in Inflammation Markers Over Time up to Month 24|The C-reactive Protein (CRP) and/or Serum amyloid A protein (SAA) were used as inflammatory markers. The normal range of CRP was 0-10 mg/L.|Baseline, Month 6 (End of treatment period), Month 12 (End of follow up period), Month 24 (End of Long term treatment period 1) and Month 36 (End of Long term treatment period 2)|The analysis was performed in the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group respectively.||milligram(s)/liter||Full Range|Median
837091|NCT01303380|Secondary|Time to Resolution of the Initial Flare After First Canakinumab Treatment|Time to resolution of the initial flare after first dose of canakinumab was determined.|Day 1 (Baseline), Day 28|The analysis was performed in the FAS population.||Days||Full Range|Median
837092|NCT01303380|Secondary|Percentage of Participants Experiencing Abdominal Pain as Assessed by Physician's Global Assessment|Abdominal pain was assessed by physician after each flare using a 5-point scale: 0 =Absent signs/symptoms; 1 = Minimal signs/symptoms; 2 = Mild; 3 = Moderate; 4 = Severe.|Baseline, Month 6 (End of treatment period), Month 12 (End of follow up period), Month 24 (End of Long term treatment period 1) and Month 36 (End of Long term treatment period 2)|The analysis was performed in the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||Percentage of participants|||Number
837093|NCT01303380|Secondary|Percentage of Participants Experiencing Lymphadenopathy as Assessed by Physician's Global Assessment|Lymphadenopathy severity was assessed by physician after each flare using a 5-point scale: 0 =Absent signs/symptoms; 1 = Minimal signs/symptoms; 2 = Mild; 3 = Moderate; 4 = Severe.|Baseline, Month 6 (End of treatment period), Month 12 (End of follow up period), Month 24 (End of Long term treatment period 1) and Month 36 (End of Long term treatment period 2)|The analysis was performed in the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||Percentage of participants|||Number
837094|NCT01303380|Secondary|Percentage of Participants Experiencing Apthus Ulcers as Assessed by Physician's Global Assessment|Apthus ulcers were assessed by physician after each flare using a 5-point scale: 0 =Absent signs/symptoms; 1 = Minimal signs/symptoms; 2 = Mild; 3 = Moderate; 4 = Severe.|Baseline, Month 6 (End of treatment period), Month 12 (End of follow up period), Month 24 (End of Long term treatment period 1) and Month 36 (End of Long term treatment period 2)|The analysis was performed in the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||Percentage of participants|||Number
837095|NCT01303380|Secondary|Percentage of Participants Experiencing Fever as Assessed by Physician's Global Assessment|Fever severity was assessed by physician after each flare using a 5-point scale: 0 =Absent signs/symptoms; 1 = Minimal signs/symptoms; 2 = Mild; 3 = Moderate; 4 = Severe.|Baseline, Month 6 (End of treatment period), Month 12 (End of follow up period), Month 24 (End of Long term treatment period 1) and Month 36 (End of Long term treatment period 2)|The analysis was performed in the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||Percentage of participants|||Number
837096|NCT01303380|Secondary|Percentage of Participants With Defined Grades of Physician Assessed Symptom Control|Participants were assessed by physician for control of signs and symptoms associated with HIDS based on 5-point scale: 0 = No control; 1 = Poor control; 2 = Somewhat control; 3 = Good control; and 4= Excellent control.|Baseline, Month 6 (End of treatment period), Month 12 (End of follow up period), Month 24 (End of Long term treatment period 1) and Month 36 (End of Long term treatment period 2)|The analysis was performed in the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||Percentage of participants|||Number
837097|NCT01303380|Secondary|Percentage of Participants With Defined Grades of Participants Assessed Symptom Control|Participants were assessed by participants/parent (participants aged 6-18 years) for control of signs and symptoms associated with HIDS based on 5-point scale: 0 = No control; 1 = Poor control; 2 = Somewhat control; 3 = Good control; and 4= Excellent control.|Baseline, Month 6 (End of treatment period), Month 12 (End of follow up period), Month 24 (End of Long term treatment period 1) and Month 36 (End of Long term treatment period 2)|The analysis was performed in the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||Percentage of participants|||Number
837098|NCT01303380|Secondary|Number of Participants With Flare Events Based on Participant Assessed HIDS Flare Severity Score|Participant's global assessment of severity of HIDS after each flare was based on HIDS flare severity score, a 5-point scale: 0 = Absent signs/symptoms; 1 = Minimal signs/symptoms; 2 = Mild; 3= Moderate; 4 = Severe. Same investigator assessed the same participant throughout the study to ensure consistency between assessments. Investigators reviewed every participant's diary at each visit after their own clinical assessment.|Baseline, Month 6 (End of treatment period), Month 12 (End of follow up period), Month 24 (End of Long term treatment period 1) and Month 36 (End of Long term treatment period 2)|The analysis was performed in the FAS population.||Number of participants|||Number
837099|NCT01303380|Secondary|Number of Participants With Flare Events Based on Physician Assessed HIDS Flare Severity Score|Physician global assessment of severity of HIDS after each flare was based on HIDS flare severity score, a 5­ point scale: 0 = Absent signs/symptoms; 1 = Minimal signs/symptoms; 2 = Mild; 3= Moderate; 4 = Severe.|Any flare event [Baseline up to Month 36 (End of long term treatment period 2)]|The analysis was performed in the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||Number of participants|||Number
837102|NCT01303380|Primary|Number of Flares Per Participant During Historical Period and Treatment Period|A flare was defined as Physician Global Assessment of HIDS flare severity score of ≥ 2 and a C­reactive protein (CRP) value > 10 mg/L. Flares during a historical period were defined as most recent 6-months in which the participant has not received treatment for their HIDS other than symptomatic treatment with NSAIDs and/or corticosteroids.|Historical period, Month 6 (End of treatment period)|The primary analysis was performed in the Full Analysis set (FAS) population defined as all participants who received at least one dose of study treatment and had at least one post baseline assessment.||Number of flares||Full Range|Median
837103|NCT01303406|Secondary|Comparison of the Percentage of Participants Randomised to Idebenone and Placebo Who Withdrew Early Due to Recurrence or Worsening of FRDA Symptoms|There was no Withdrawal due to recurrence or worsening of FRDA symptoms|Within 2 months (i.e. Early withdrawal visit)|||percentage of patients|||Number
837104|NCT01303406|Primary|Patient Assessment of Treatment Assignment: Comparison of the Proportions of Patients Randomised to Idebenone and Placebo Who Assessed That They Received Idebenone|The primary efficacy endpoint was the comparison of the number of patients randomized to idebenone and placebo, who assessed that they received idebenone treatment.|At 2 months after study start|||participants|||Number
837105|NCT01303445|Secondary|Percentage Peak-to-trough Fluctuation (%PTF)|PTF = 100*((Cmax-Cmin)/Cavg) where Cavg=(AUC0-12)/12.|7 days|The pharmacokinetic data set (PK set) and the pharmacodynamic data set (PD set) include all treated subjects with data that do not have a relevant protocol violation (relevant to PK or PD). No data collected for Omeprazole arm since no plasma dipyridamole was expected for this treatment.||percent of average hourly plasma conc.||Standard Deviation|Mean
837106|NCT01303445|Secondary|Inhibition of Platelet Aggregation at 12 Hours Post Dose (IPA12)|IPA12 equals the platelet aggregation measured 12 hours post dose divided by the platelet aggregation measured at baseline (multiplied by 100).|7 days|The pharmacokinetic data set (PK set) and the pharmacodynamic data set (PD set) include all treated subjects with data that do not have a relevant protocol violation (relevant to PK or PD). No data collected for Omeprazole arm since no platelet inhibition was expected for this treatment.||percent of baseline platelet aggregation||Standard Deviation|Mean
837107|NCT01303445|Secondary|Plasma Dipyridamole Minimum Concentration (Cmin)|Minimum measured concentration of dipyridamole in plasma|7 days|The pharmacokinetic data set (PK set) and the pharmacodynamic data set (PD set) include all treated subjects with data that do not have a relevant protocol violation (relevant to PK or PD). No data collected for Omeprazole arm since no plasma dipyridamole was expected for this treatment.||nanogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
837108|NCT01303445|Primary|Inhibition of Platelet Aggregation at 4 Hours Post Dose (IPA4)|IPA4 equals the platelet aggregation measured 4 hours post dose divided by the platelet aggregation measured at baseline (multiplied by 100).|7 days|The pharmacokinetic data set (PK set) and the pharmacodynamic data set (PD set) include all treated subjects with data that do not have a relevant protocol violation (relevant to PK or PD). No data collected for Omeprazole arm since no platelet inhibition was expected for this treatment.||percent of baseline platelet aggregation||Standard Deviation|Mean
837109|NCT01303445|Primary|Plasma Dipyridamole Area Under Plasma Concentration-time Curve From Zero to 12 Hours (AUC0-12)|Area under the concentration time curve of the analyte in plasma from 0 to 12 hours at steady state|7 days|The pharmacokinetic data set (PK set) and the pharmacodynamic data set (PD set) include all treated subjects with data that do not have a relevant protocol violation (relevant to PK or PD). No data collected for Omeprazole arm since no plasma dipyridamole was expected for this treatment.||(nanogram/milliliter)*hours||Geometric Coefficient of Variation|Geometric Mean
837110|NCT01303445|Primary|Plasma Dipyridamole Maximum Concentration (Cmax)|Maximum measured concentration of dipyridamole in plasma|7 days|The pharmacokinetic data set (PK set) and the pharmacodynamic data set (PD set) include all treated subjects with data that do not have a relevant protocol violation (relevant to PK or PD). No data collected for Omeprazole arm since no plasma dipyridamole was expected for this treatment.||nanogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
837111|NCT01303510|Secondary|Incidence of Solicited Systemic Adverse Events|Safety assessments are made by the investigator at baseline and on Day 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination|Days 1 to 4 inclusive, and Day 22|Safety population||Subjects|||Number
837112|NCT01303510|Primary|Fold Increase in Geometric Mean Titer (GMT)|GMT-fold increase - calculated as the GMT on Day 22 divided by the baseline GMT value|Day 22/Day 1|ITT/ATP||Fold (ratio)|||Number
837113|NCT01303510|Primary|Seroprotection|Seroprotection rate, defined as the proportion of subjects with HI antibody titer ≥1:40|Day 22 ± 2 days|ITT/ATP||Subjects|||Number
837114|NCT01303510|Primary|Seroconversion|Seroconversion rate was defined as the proportion of subjects with ≥4-fold increase in haemagglutination inhibition (HI) antibody titer and with a titer of ≥1:40|Day 22 ± 2 days|Intention-to-treat (ITT) and According-to-protocol (ATP) populations exclude one subject lost to follow up||Subjects|||Number
837115|NCT01303510|Secondary|Safety: Incidence of Solicited Local Adverse Events|Safety assessments are made by the investigator at baseline and on Day 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination|Days 1 to 4 inclusive, and Day 22|Safety population includes all subjects who received study vaccine||Subjects|||Number
837116|NCT01303627|Primary|Smooth cLMA Removal Condition (Score 1)|cLMA removal was accepted as successful (score 1) if none of the complications coughing, teeth clenching, gross purposeful movements, breath holding, laryngospasm, and desatura- tion to SpO2\90% was observed. If any of these compli- cations was observed it was regarded as unsuccessful (score 2)|At the end of the surgery|||percentage of participants|||Number
837117|NCT01303744|Secondary|Changes in Plasma ΔTNFα Concentrations||29 days|ITT||pg/ml||Standard Error|Mean
837118|NCT01303744|Secondary|Measurement of Trough CHF 5074 Plasma Levels|evaluate the pharmacokinetics (PK) of CHF 5074 in patients with MCI.|Days 85|||ng/ml||Standard Deviation|Mean
837119|NCT01303744|Primary|Differences in ∆sCD40L Levels Between CHF 5074 Doses and Placebo at Any Specific Time Point|To assess if there were differences in ΔsCD40L levels between CHF 5074 doses and placebo|up to 12 weeks|ITT||pg/ml||Standard Error|Mean
837972|NCT01309919|Primary|Bleeding Patterns|Number of bleeding and spotting days in the first six weeks and subsequent six weeks postpartum|12 weeks post-partum|We were able to analyze all returned bleeding diaries (25 participants in IUD Arm, 27 participants in Diary Arm)||days||Full Range|Median
837120|NCT01303835|Secondary|Effects of Low-dose Naltrexone Versus Placebo on Change in Neurocognitive Function From Baseline|Patients completed neurocognitive testing at each QoL measurement assessment. Neurocognitive function was measured via a computerized neurocognitive test battery called CNS Vital Signs. The battery consists of 7 tests that assess verbal and visual memory, finger tapping, symbol digit coding, the Stroop Test, a test of shifting attention, and continuous performance. The battery provides scores over 9 domains with higher scores indicating better performance. Scores were normalized to a standard score mean of 100 and standard deviation of 15 using a normative sample. The mean difference in score in each domain between the 3rd QoL measurement (approximately 16 weeks from initial assessment) and the initial baseline assessment are reported. A difference greater than 0 indicates an increase in mean score, while a difference less than 0 indicates a decrease in mean score.|Baseline and 16 weeks|This analysis only includes those patients who completed both the initial CNS Vital Signs assessments and the 16 week assessments, and thus number of participants may not match those reported in the participant flow module, which reports number of participants completing the trial at 24 weeks.||Scores on a Scale||Standard Deviation|Mean
837121|NCT01303835|Secondary|Effects of Low-dose Naltrexone Versus Placebo on Change in Functional Capacity From Baseline|Patients completed the 6-minute walk test (6MWT) at each QoL measurement assessment. The 6 minute walk test is a measure of functional capacity in which the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes is measured. The mean difference in distance traveled (in meters) between the 3rd QoL measurement (approximately 16 weeks from initial assessment) and the initial baseline assessment are reported. A difference greater than 0 indicates an increase in distance traveled, while a difference less than 0 indicates a decrease.|Baseline and 16 weeks|This analysis only includes those patients who completed both the initial 6MWT assessments and the 16 week assessments, and thus number of participants may not match those reported in the participant flow module, which reports number of participants completing the trial at 24 weeks.||Meters||Standard Deviation|Mean
837122|NCT01303835|Primary|Effects of Low-dose Naltrexone Versus Placebo on Change in Quality of Life (QoL) in High-grade Glioma Patients Undergoing Standard Chemoradiation From Baseline|"The difference in QoL scores between the 3rd QoL measurement (approximately 16 weeks from initial assessment) and the initial baseline assessment are reported. QoL instruments included are listed below. Higher scores indicate more favorable outcomes unless otherwise indicated.
Functional Assessment of Cancer Therapy-Brain (FACT-Br) measures general QoL reflecting symptoms associated with brain malignancies (range 0-132)
Functional Assessment of Chronic Illness Therapy (FACIT-F) measures level of fatigue during patients’ usual daily activities (range 0-52)
Epworth Sleepiness Scale measures level of daytime sleepiness. Note that higher scores indicate a greater level of sleepiness (range 0-24)
Medical Outcomes Survey (MOS) measures QoL including physical, mental and general health via 8 domains (range 0-100 for each domain)
Zung Self-Rating Depression Scale quantifies the depressed status of a patient. Lower scores indicate more favorable outcome (range 20-80) A difference"|Baseline and 16 weeks|This analysis only includes those patients who completed both the initial QOL assessments and the 16 week QoL assessments, and thus number of participants may not match those reported in the participant flow module, which reports number of participants completing the trial at 24 weeks.||Scores on a Scale||Standard Deviation|Mean
837123|NCT01303861|Secondary|Continuous Cigarette Abstinence From Quit Date|Secondary outcome will include continuous abstinence from quit date to end of treatment (week 11).|From Quit date to end of treatment (week 11)|1 subject from varenicline group excluded from analysis due to pregnancy. 1 subject from Nicotine Patches only group excluded due to meeting an exclusion criteria.||participants||95% Confidence Interval|Number
837124|NCT01303861|Secondary|Seven Day Point Abstinence From Cigarette Smoking|Secondary outcome will include point abstinence (no smoking in the previous 7-day) at 6 months post-quit.|Six months post quit date|1 subject from varenicline group excluded from analysis due to pregnancy. 1 subject from Nicotine Patches only group excluded due to meeting an exclusion criteria.||participants||95% Confidence Interval|Number
837125|NCT01303861|Primary|Four-week Continuous Abstinence From Cigarette Smoking|The primary dependent measures will be continuous four-week abstinence from weeks 8-11 post target quit date, defined as a self-report of no smoking confirmed by expired air carbon monoxide.|Study week 8 thru week 11|1 subject from varenicline group excluded from analysis due to pregnancy. 1 subject from Nicotine Patches only group excluded due to meeting an exclusion criteria.||percentage of participants||95% Confidence Interval|Number
837126|NCT01304082|Secondary|Rank-transformed Pain Score Upon Needle Stick.|"Pain score upon needle stick:
The pain score is a validated 11-point numeric rating scale in which patients rate pain between 0 (no pain) and 10 (worst pain imaginable)."|1 minute after each injection|||rank||95% Confidence Interval|Least Squares Mean
837127|NCT01304082|Secondary|Rank-transformed Time (Seconds) Until Anesthesia|Rank-transformed time (seconds) until anesthesia will be assessed using a repeated sensory stimulus.|0-180 seconds after each injection|||rank||95% Confidence Interval|Least Squares Mean
837128|NCT01304082|Secondary|Rank-transformed Time (Seconds) Until Hypoesthesia|Rank-transformed time (seconds) until hypoesthesia will be assessed using a sensory stimulus|0-180 seconds after each injection.|||rank||95% Confidence Interval|Least Squares Mean
837129|NCT01304082|Primary|Rank-transformed Pain Score|"Pain score upon injection of local anesthetic:
the pain score is a validated 11-point numeric rating scale in which patients rate pain between 0 (no pain) and 10 (worst pain imaginable)."|immediate, upon injection of each solution|||rank||95% Confidence Interval|Least Squares Mean
837130|NCT01304147|Secondary|Systematic Assessment for Treatment Emergent Effects (SAFTEE)|This is a self-report measure for systematically assessing 48 possible adverse events. It documents their severity, relationship to study drug, and the action taken.|2 weeks|Number of events, more detailed in adverse event section||events|||Number
837131|NCT01304147|Primary|Montgomery-Asberg Depression Rating Scale (MADRS)|"Number of patients meeting response criteria of >=50% decrease in MADRS score from baseline , ie, difference in depressive symptoms using MADRS instrument, 24 hours following drug administration
10-item instrument used for the evaluation of depressive symptoms in adults and for the assessment of any changes to those symptoms. Each of the 10 items is rated on a scale of 0 to 6, with differing descriptors for each item. These individual item scores are added together to form a total score, which can range between 0 and 60 points."|24 hours|20 patients randomized and 18 completed both treatment periods||participants|||Number
837973|NCT01309997|Secondary|Percentage of CD27+ B Cells in Responders (SCR) and Non-responders|%CD27+ B cells|6 months|||percentage of CD27+ B cells||Full Range|Mean
837132|NCT01304238|Secondary|Number of Participants Who Experienced Skin Changes (Erythema and Necrosis) After the Occurrence of HIT II|Participants’ medical records were used to abstract data that were collected on standardized hard copy Case Report Forms (CRFs). Erythema is a redness of the skin caused by hyperemia. Necrosis is the premature death of cells or tissues.|19 January 2005 to 25 October 2009|All documented participants diagnosed with suspected acute HIT II and a 4T Score of ≥4 who had received at least one dose of argatroban, lepirudin, danaparoid, or fondaparinux. The 4T score (range: 0-8) was developed to predict the probability of HIT.||participants|||Number
837133|NCT01304238|Secondary|Number of Participants Who Were Diagnosed With Thrombocytopenia (Recurrent of Persistent) After the Occurrence of HIT II|Participants’ medical records were used to abstract data that were collected on standardized hard copy Case Report Forms (CRFs). Thrombocytopenia after HIT-II was documented in the participant files.|19 January 2005 to 25 October 2009|All documented participants diagnosed with suspected acute HIT II and a 4T Score of ≥4 who had received at least one dose of argatroban, lepirudin, danaparoid, or fondaparinux. The 4T score (range: 0-8) was developed to predict the probability of HIT.||participants|||Number
837134|NCT01304238|Secondary|Number of Participants Who Underwent Amputation After the Occurrence of HIT II|Participants’ medical records were used to abstract data that were collected on standardized hard copy Case Report Forms (CRFs).|19 January 2005 to 25 October 2009|All documented participants diagnosed with suspected acute HIT II and a 4T Score of ≥4 who had received at least one dose of argatroban, lepirudin, danaparoid, or fondaparinux. The 4T score (range: 0-8) was developed to predict the probability of HIT.||participants|||Number
837135|NCT01304238|Secondary|Number of Participants With Fatal Complications After the Occurrence of HIT II|Participants’ medical records were used to abstract data that were collected on standardized hard copy Case Report Forms (CRFs). A fatal complication is defined as a complication resulting in death.|19 January 2005 to 25 October 2009|All documented participants diagnosed with suspected acute HIT II and a 4T Score of ≥4 who had received at least one dose of argatroban, lepirudin, danaparoid, or fondaparinux. The 4T score (range: 0-8) was developed to predict the probability of HIT.||participants|||Number
837136|NCT01304238|Secondary|Number of Participants Diagnosed With Bleeding After the Occurrence of HIT II|Participants’ medical records were used to abstract data that were collected on standardized hard copy Case Report Forms (CRFs). Bleeding was documented in the participant files.|19 January 2005 to 25 October 2009|All documented participants diagnosed with suspected acute HIT II and a 4T Score of ≥4 who had received at least one dose of argatroban, lepirudin, danaparoid, or fondaparinux. The 4T score (range: 0-8) was developed to predict the probability of HIT.||participants|||Number
837137|NCT01304238|Primary|Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II|Thrombosis is a clotting in a blood vessel. Pulmonary embolism is a clot, usually from the deep veins of the legs, carried away with the venous bloodstream into the lungs, where it may block pulmonary vessels. Participants’ medical records were used to abstract data that were collected on standardized hard copy Case Report Forms (CRFs).|19 January 2005 to 25 October 2009|All documented participants diagnosed with suspected acute HIT II and a 4T Score of ≥4 who had received at least one dose of argatroban, lepirudin, danaparoid, or fondaparinux. The 4T score (range: 0-8) was developed to predict the probability of HIT.||participants|||Number
837138|NCT01304277|Secondary|Overall Summary of TEAEs by Treatment (Replagal RB and Replagal AF)|To Assess Safety and Tolerability by Anti-agalsidase Alfa Antibody Status, concomitant medication, vital signs and ECG.|Week 2 to EOS|||participants|||Number
837139|NCT01304277|Secondary|To Assess Safety and Tolerability by Anti-agalsidase Alfa Antibody Status (in Serum) at End of Study||EOS|||participants|||Number
837140|NCT01304277|Secondary|Dose-normalized Maximum Serum Concentration (Cmax/Dose)||Week 0 to Week 14|||Ratio||90% Confidence Interval|Geometric Mean
837141|NCT01304277|Secondary|Dose-normalized AUC Extrapolated to Infinity (AUC∞/Dose)||Week 0 to Week 14|||Ratio||90% Confidence Interval|Geometric Mean
837142|NCT01304277|Secondary|Dose-normalized Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Sample (AUClast/Dose)||Week 0 to Week 14|||Ratio||90% Confidence Interval|Geometric Mean
837143|NCT01304277|Secondary|Change From Baseline to Week 16 (EOS) in Plasma Gb3 Levels||Baseline to EOS|||(nmol/mL)||Standard Deviation|Mean
837144|NCT01304277|Primary|Change From Baseline to Week 16 (EOS) in Urine Gb3 Levels||Baseline to EOS|||(nmol/g creatinine)||Standard Deviation|Mean
837145|NCT01304316|Secondary|Pulse Rate Maximum Change From Baseline||Baseline, 5, 10, 15, 20, 25, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120 minutes|||bpm||Standard Deviation|Mean
837146|NCT01304316|Secondary|Systolic BP Maximum Change From Baseline||Baseline, 5, 10, 15, 20, 25, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120 minutes|||mmHg||Standard Deviation|Mean
837147|NCT01304316|Secondary|Diastolic BP Maximum Change From Baseline||Baseline, 5, 10, 15, 20, 25, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120 minutes|||mmHg||Standard Deviation|Mean
837148|NCT01304316|Secondary|Pulse Oximetry Maximum Change From Baseline||Baseline, 5, 10, 15, 20, 25, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120 minutes|||% oxygen||Standard Deviation|Mean
837149|NCT01304316|Primary|Half Life of PBBA|Extra-vascular, non-compartmental analysis is used to derive pharmacokinetic parameters; estimated from observed plasma concentration values, the dose administered, the AUCs, and the terminal elimination phase rate constant for each dose group|Baseline, 5, 10, 15, 20, 25, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120 minutes|Only 8 subjects in the standard dose group and 11 subjects in the high dose group had sufficient concentration levels to calculate Cmax.||h||Standard Deviation|Mean
837150|NCT01304316|Primary|Half Life of Tetracaine|Extra-vascular, non-compartmental analysis is used to derive pharmacokinetic parameters; estimated from observed plasma concentration values, the dose administered, the AUCs, and the terminal elimination phase rate constant for each dose group|Baseline, 5, 10, 15, 20, 25, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120 minutes|An insufficient number of tetracaine plasma concentrations existed in each subject to determine a half life for tetracaine|||||
837151|NCT01304316|Primary|Half Life of Oxymetazoline|Extra-vascular, non-compartmental analysis is used to derive pharmacokinetic parameters; estimated from observed plasma concentration values, the dose administered, the AUCs, and the terminal elimination phase rate constant for each dose group|Baseline, 5, 10, 15, 20, 25, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120 minutes|Only 7 subjects in the 0.3 mg dose group and 0.6 mg dose group had sufficient concentration levels to calculate the half life.||h||Standard Deviation|Mean
837152|NCT01304316|Primary|Cmax of PBBA|Extra-vascular, non-compartmental analysis is used to derive pharmacokinetic parameters; estimated from observed plasma concentration values, the dose administered, the AUCs, and the terminal elimination phase rate constant for each dose group|Baseline, 5, 10, 15, 20, 25, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120 minutes|||ng/mL||Standard Deviation|Mean
837153|NCT01304316|Primary|Cmax of Tetracaine|Extra-vascular, non-compartmental analysis is used to derive pharmacokinetic parameters; estimated from observed plasma concentration values, the dose administered, the AUCs, and the terminal elimination phase rate constant for each dose group|Baseline, 5, 10, 15, 20, 25, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120 minutes|Only 4 subjects in the 18 mg dose group and 7 subjects in the 36 mg dose group had sufficient concentration levels to calculate Cmax.||ng/mL||Standard Deviation|Mean
837154|NCT01304316|Primary|Cmax of Oxymetazoline|Extra-vascular, non-compartmental analysis is used to derive pharmacokinetic parameters; estimated from observed plasma concentration values, the dose administered, the AUCs, and the terminal elimination phase rate constant for each dose group|Baseline, 5, 10, 15, 20, 25, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120 minutes|Only 11 subjects in the 0.3 mg dose group had sufficient concentration levels to calculate Cmax.||ng/mL||Standard Deviation|Mean
837155|NCT01304329|Secondary|Simvastatin: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)|"Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point.
The geometric mean and geometric coefficient of variation (gCV) are adjusted values."|0 hours (h), 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: PK set included all evaluable subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of PK.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
837156|NCT01304329|Secondary|Empa: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)|"Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point.
The geometric mean and geometric coefficient of variation (gCV) are adjusted values."|0 hours (h), 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: PK set included all evaluable subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of PK.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
837157|NCT01304329|Primary|Simvastatin: Maximum Measured Concentration (Cmax)|"Maximum measured concentration of the analyte in plasma, per period.
The geometric mean and geometric coefficient of variation (gCV) are adjusted values."|0 hours (h), 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: PK set included all evaluable subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of PK.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
837158|NCT01304329|Primary|Empa: Maximum Measured Concentration (Cmax)|"Maximum measured concentration of the analyte in plasma, per period.
The geometric mean and geometric coefficient of variation (gCV) are adjusted values"|0 hours (h), 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: PK set included all evaluable subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of PK.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
837159|NCT01304329|Primary|Simvastatin: Area Under the Curve 0 to Infinity (AUC0-∞)|"Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity. Simvastatin acid is an active metabolite of simvastatin.
The geometric mean (gMean) and geometric coefficient of variation (gCV) are adjusted values."|0 hours (h), 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: PK set included all evaluable subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of PK.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
837160|NCT01304329|Primary|Empa: Area Under the Curve 0 to Infinity (AUC0-∞)|"Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity.
The geometric mean (gMean) and geometric coefficient of variation (gCV) are adjusted values."|0 hours (h), 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: PK set included all evaluable subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of PK.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
837161|NCT01304498|Secondary|Percentage of Participants With One or More Serious Adverse Events|A serious adverse event is an adverse event that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is a cancer, or may jeopardize the participant and may require medical or surgical intervention. The percentage of participants with one or more serious adverse events was assessed.|Up to Month 7|All participants who received at least one study vaccination and had safety follow-up data||Percentage of participants|||Number
837162|NCT01304498|Secondary|Percentage of Participants With Maximum Oral Temperature ≥37.8°C|The percentage of participants with maximum oral temperature ≥37.8°C was assessed.|Up to 15 days after any vaccination|All participants who received at least one study vaccination and had safety follow-up data||Percentage of participants|||Number
837163|NCT01304498|Secondary|Percentage of Participants With One or More Systemic Adverse Events|The percentage of participants with one or more systemic adverse events was assessed.|Up to 15 days after any vaccination|All participants who received at least one study vaccination and had safety follow-up data||Percentage of participants|||Number
837164|NCT01304498|Secondary|Percentage of Participants With One or More Injection-site Adverse Reactions|The percentage of participants with one or more injection-site adverse reactions (solicited or unsolicited) was assessed.|Up to 5 days after any vaccination|All participants who received at least one study vaccination and had safety follow-up data||Percentage of participants|||Number
837165|NCT01304498|Secondary|Percentage of Participants With One or More Adverse Events|An adverse event is defined as any unfavourable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine, is also an adverse event. The percentage of participants with one or more adverse events was assessed.|Up to Month 7|All participants who received at least one study vaccination and had safety follow-up data||Percentage of participants|||Number
837166|NCT01304498|Secondary|Percentage of Participants Who Are Seropositive for HPV Types 6/11/16/18|Serum antibodies to HPV types were measured with a Competitive Luminex Immunoassay. The serostatus cutoffs (milli Merck Units/mL) for HPV types were as follows: HPV Type 6: ≥30; HPV Type 11: ≥16; HPV Type 16: ≥20; HPV Type 18: ≥24. The percentage of participants who were seropositive according to these cutoffs was assessed.|4 weeks postdose 3 (Month 7)|All randomized participants. The n values are participants who received all 3 vaccinations within acceptable day ranges, had Month 7 serology to the HPV type within acceptable day ranges, were seronegative to the HPV type at Day 1, and had no protocol violations that interfered with evaluation of immune response.||Percentage of participants||95% Confidence Interval|Number
837167|NCT01304498|Secondary|GMTs to HPV Types 6 and 11|Serum antibodies to HPV types 6 and 11 were measured with a Competitive Luminex Immunoassay.|4 weeks postdose 3 (Month 7)|All randomized participants. The n values are participants who received all 3 vaccinations within acceptable day ranges, had Month 7 serology to the HPV type within acceptable day ranges, were seronegative to the HPV type at Day 1, and had no protocol violations that interfered with evaluation of immune response.||milli Merck Units/mL||95% Confidence Interval|Geometric Mean
837168|NCT01304498|Primary|Geometric Mean Titers (GMTs) to HPV Types 16 and 18|Serum antibodies to HPV types 16 and 18 were measured with a Competitive Luminex Immunoassay.|4 weeks postdose 3 (Month 7)|All randomized participants. The n values are participants who received all 3 vaccinations within acceptable day ranges, had Month 7 serology to the HPV type within acceptable day ranges, were seronegative to the HPV type at Day 1, and had no protocol violations that interfered with evaluation of immune response.||milli Merck Units/mL||95% Confidence Interval|Geometric Mean
837169|NCT01304589|Secondary|24-hour Vulvar Pain|Measures average vulvar pain over 24-hours on daily diary|18 weeks|22 subjects were randomized to study medication with 18 of the 22 subjects completing all of the study visits. Analysis population includes all 18 eligible subjects who completed all of the study visits.||units on a scale||Standard Deviation|Mean
837170|NCT01304589|Secondary|Coital Pain|Intercourse pain is measured by completing a daily diary|18 weeks|22 subjects were assigned to study medication with 18 of the 22 subjects completing all of the study visits. Analysis population includes the 18 eligible subjects who completed all of the study visits.||units on a scale||Standard Deviation|Mean
837171|NCT01304589|Secondary|Tampon Pain|"Subjects completed a tampon insertion pain test once a week in their daily diary. The values were averaged and compared pre-treatment versus post-treatment."|18 weeks|22 subjects were eligible and received study medication. Analysis population includes all 22 eligible subjects.||units on a scale||Standard Deviation|Mean
837172|NCT01304589|Primary|Pain Rating Index|"The primary outcome measure will be pain ratings on the Pain Rating Index (PRI) of the short-form McGill Pain Questionnaire (SF-MPQ), which consists of 15 representative words from the sensory (n = 11) and affective (N = 4) categories of the standard, long-form (LF-MPQ). On the PRI, each descriptor is ranked by the patient on an intensity scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. Total score - 0 equals no pain to 45 equals severe pain. The paired t-test was used to compare the PRI score at baseline and at 18 weeks or to further clarify, pre-treatment versus post-treatment comparison."|18 weeks|22 subjects were eligible and received study medication. Analysis population included all 22 eligible subjects.||units on a scale||Standard Deviation|Mean
837173|NCT01304641|Secondary|Percentage of Participants Who Adhered to Index Therapy|Percentage of participants who adhered to index therapy was evaluated. Treatment adherence was defined as the number of days covered by index medication divided by the number of days in the post-index period, expressed as a percentage.|At least 3 months from the post-index date (baseline) or end of study (28 February 2009)|Evaluable analysis population included all participants who met inclusion criteria.||Percentage of participants|||Number
837174|NCT01304641|Secondary|Length of Post-index Period|Post-index period included time during which participants were observed for a minimum of 3 months following index date (fill date on which first observed atorvastatin or simvastatin was filled during the participant identification period) until disenrollment or end of study treatment (28 February 2009).|Index date (baseline) up to end of study (28 February 2009)|Evaluable analysis population included all participants who met inclusion criteria.||Days||Standard Deviation|Mean
837175|NCT01304641|Secondary|Number of Participants Per Dose|Index dose was categorized as low dose (atorvastatin 10 mg, simvastatin up to 20 mg), medium dose (atorvastatin 20 mg, simvastatin 40 mg), and high dose (atorvastatin 40 or 80 mg, simvastatin 80 mg).|At least 3 months from the post-index date (baseline) or end of study (28 February 2009)|Evaluable analysis population included all participants who met inclusion criteria.||Participants|||Number
837176|NCT01304641|Secondary|Mean Dose|The first observed study medication fill during the participation identification period was defined as the index drug. The initial dose of the index drug was determined based on the pharmacy claims.|At least 3 months from the post-index date (baseline) or end of study (28 February 2009)|Evaluable analysis population included all participants who met inclusion criteria.||mg||Standard Deviation|Mean
837177|NCT01304641|Secondary|Low-density Lipoprotein Cholesterol (LDL-C)||At least 3 months from the post-index date (baseline) or end of study (28 February 2009)|Evaluable analysis population included all participants who met inclusion criteria. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.||milligram/deciliter (mg/dL)||Standard Deviation|Mean
837178|NCT01304641|Primary|Hazard Ratio for First Cardiovascular (CV) Event|Hazard ratio of atorvastatin versus simvastatin for first CV event. Hazard ratio of atorvastatin versus simvastatin was obtained from a Cox proportional hazards model.|At least 3 months from the post-index date (baseline) or end of study (28 February 2009)|Evaluable analysis population included all participants who met inclusion criteria.||Participants|||Number
837179|NCT01304641|Primary|Number of Participants With Post-index Cardiovascular (CV) Events|CV events were defined as an inpatient or emergency department admission for heart failure (HF), myocardial infarction (MI), ischemic heart disease (IHD), cerebrovascular disease, peripheral vascular disease (PVD), aortic aneurysm, and/or revascularization. CV events were identified using medical claims.|At least 3 months from the post-index date (baseline) or end of study (28 February 2009)|Evaluable analysis population included all participants who met inclusion criteria.||Participants|||Number
837180|NCT01304693|Secondary|Duration of Effect Measured by the Time From Randomization to Receipt of Standard of Care as Determined by the Investigator Based on Protocol Criteria|Standard of care (SOC) therapy for exudative AMD was implemented if any protocol-specified criteria relating to CSFT, best-corrected visual acuity, or clinically significant intraocular hemorrhages in the study eye were met, in the opinion of the Investigator.|Time to event, up to Month 6|ITT: All patients who were randomized, received study drug, and completed at least 1 scheduled on-therapy study visit.||Days||Inter-Quartile Range|Median
837181|NCT01304693|Primary|Change From Baseline at Month 1 in Central Subfield Thickness (CSFT) as Measured by Spectral Domain Ocular Coherence Tomography (SD-OCT)|CSFT is a retinal thickness measurement and was measured with SD-OCT. A thickening of the retina is characteristic of wet AMD, and a reduction in CSFT may indicate an improvement in ocular health. One eye (ie, study eye) contributed to the mean.|Baseline, Month 1|This analysis population includes all patients who were randomized, received study drug, and completed at least 1 scheduled on-therapy study visit (ITT). Efficacy data from visits occurring after standard of care (SoC) were censored and replaced based on LOCF,i.e. by the data observed at the time of the SoC decision.||microns||Standard Deviation|Mean
837182|NCT01304706|Primary|Number of Participants With Adverse Events|This is a measurement of the number of subjects who experienced an adverse event and/or a serious adverse event during the trial.|12 months|||participants|||Number
837183|NCT01304966|Secondary|Cotreta-Derkay Score|"We compared disease severity(Cotreta-Derkay score) between groups of children with two different HPV genotypes
Coltera and Derkay have evolved a staging system to stage recurrent papillomatous lesions involving the respiratory tract.
Coltera-Derkay method of staging :
Clinical score:
Voice: Normal - 0, Abnormal - 1, Aphonia - 2
Stridor: Absent - 0, Present on activity - 1, Present at rest - 2
Respiratory distress - None - 0, Mild - 1, Moderate - 2, Severe - 3, Extreme - 4.
Anatomical score:
For each site - 0 = none, 1=surface lesion, 2= raised lesion, 3=bulky lesion.
Total score = Anatomical score + Total clinical score"|12 months|||score||Standard Deviation|Mean
837184|NCT01304966|Primary|Human Papillomavirus Genotypes|Distribution of Human papillomavirus(HPV) genotypes identified in the biopsy|12 months|We found positive HPV DNA in all children. HPV type 6 and HPV type 11 caused recurrent respiratory papillomatosis in 6 (40%) and 9(60%) of cases,respectively.||participants|||Number
837185|NCT01305044|Primary|Satisfaction With the Randomized Controlled Trial|The 12-week intervention assessed satisfaction with intervention(0=strongly agree to 4=strongly disagree).|13 weeks|Power calculations indicated that a sample size of 42 would be sufficient to detect 15 point change in SF-36, with 88% power at 5% significance level. Analysis were per protocol because the sample size was too small for imputation techniques and there was no follow-up data on withdrawn participants for intent-to-treat analysis.||units on a scale||Inter-Quartile Range|Median
837186|NCT01305044|Secondary|Inflammatory Cytokines|Fasting blood samples were collected in the morning for inflammatory cytokines. Prior to blood draws, we ensured that participants did not experience illness or fever at the time of the blood draw. The assayed cytokines included pro-inflammatory cytokines interleukin(IL)-12, IL-6, tumor necrosis factor (TNF)-α, and anti-inflammatory cytokines IL-10 and IL-4.|13-weeks|||pg/ml||Inter-Quartile Range|Median
837187|NCT01305044|Secondary|Cortisol Area-Under-Curve (AUC)|Five saliva samples (awakening, 30 minutes after awakening, noon, 5pm, & 10pm) were collected on a weekend day at one week after class completion. Cortisol was measured in nmol/L. Cortisol AUC was calculated using the five timepoints with the trapezoid rule. The groups were compared at post-intervention on their log transformed cortisol AUC controlling for baseline cortisol and reported as adjusted means. Four participants with high cortisol profiles across the five collection times (with suspected contamination from gum bleeding) and participants whose collection time was beyond a one hour window were excluded.|13-weeks|||nmol*hr/L||Standard Error|Mean
837188|NCT01305044|Secondary|Blood Pressure|Systolic and Diastolic blood pressure were assessed at the study's physical assessment sessions.|13-weeks|Please refer to power calculation detailed in Primary Outcome Measure.||mm Hg||Standard Error|Mean
837189|NCT01305044|Secondary|Five-Facet Mindfulness Questionnaire|The Five-Facet Mindfulness questionnaire produces a total score and five facet subscales (observing, describing, acting with awareness, nonjudging, & nonreactivity). These are summation scores, and the scores range from 8 to 40 (except for the nonreactivity facet which ranges from 7 to 35). Higher scores indicate more mindfulness. The Total Score ranges from 39-195, with higher scores indicating more mindfulness.|13-weeks|||units on a scale||Inter-Quartile Range|Median
837190|NCT01305044|Secondary|Pittsburgh Sleep Quality Index|The Pittsburgh Sleep Quality produces a global score. The range is 0 to 21, higher scores indicate worse sleep quality.|13-weeks|||units on a scale||Inter-Quartile Range|Median
837191|NCT01305044|Secondary|Impact of Events Scale|The Impact of Event Scale assesses cancer-specific distress. Each item is scored 0 (not at all), 1 (rarely), 3 (sometimes)or 5 (often), with the higher scores reflecting more stressful impact. It has a total score and two subscales (avoidance & intrusion). The two subscales are scored by summing their corresponding items and the total score is the sum of two subscales. The scores for the intrusive subscale range from 0 to 35, and scores for the avoidance subscale range from 0 to 40. The Total Score ranges from 0-75, with higher scores reflecting more stressful impact.|13-weeks|||units on a scale||Inter-Quartile Range|Median
837192|NCT01305044|Secondary|Perceived Stress Scale|The 10-item perceived stress scale produces a summation score. Scores can range from 0 to 40, with higher scores indicating more stress.|13 weeks|||units on a scale||Inter-Quartile Range|Median
837193|NCT01305044|Secondary|Health-Related Quality of Life (Short Form (SF)-36v1)|SF-36v1 Health Survey assesses quality of life and produces mental and physical component summary scores, with a score range of 0 to 100. Higher scores indicate better quality of life.|13 weeks|Please refer to power calculation detailed in Primary Outcome Measure.||units on a scale||Standard Error|Mean
837194|NCT01305044|Primary|Retention Rates and Class Attendance|The 12-week intervention assessed retention in the study (percentage of how many participants remained enrolled the entire intervention), class attendance (percentage out of possible classes)|13 weeks|Power calculations indicated that a sample size of 42 would be sufficient to detect 15 point change in SF-36, with 88% power at 5% significance level. Analysis were per protocol because the sample size was too small for imputation techniques and there was no follow-up data on withdrawn participants for intent-to-treat analysis.||percentage of participants|||Number
837195|NCT01296646|Secondary|Percent Days Abstinent|Percentage of abstinence days as derived from the Timeline Follow-Back (TLFB) for the entire medication period.|12 weeks|||percentage of days||Standard Deviation|Mean
837196|NCT01296646|Primary|Percent Heavy Drinking Days|Percentage of heavy drinking days as derived from the Timeline Follow-back (TLFB) for the entire medication period. A heavy drinking day is defined as 5 or more standard drinks for a man and 4 or more standard drinks for a woman. A standard drink is 12-14 grams of ethanol or the amount contained in a 12 oz beer, 5 oz of wine or 1 1/2 oz of hard liquor.|12 weeks|||percentage of days||Standard Deviation|Mean
837197|NCT01296672|Secondary|T2:ERG ( A Gene on Chromosome 21q22.2 That Encodes an Androgen-regulated Transmembrane Serine Protease Ratio to Estrogen Related Gene) Score AUC|Area Under the Receiver Operating Characteristic Curve (ROC-AUC) of the T2:ERG ( A Gene on Chromosome 21q22.2 That Encodes an Androgen-regulated Transmembrane Serine Protease Ratio to Estrogen Related Gene) Score to Predict the Risk of Prostate Cancer|Reported at 90 days: assessed at baseline, 30 days, 60 days, and 90 days|Receiving biopsy||Ratio||95% Confidence Interval|Number
837198|NCT01296672|Secondary|PCA3 (Prostate Cancer Antigen 3)Score AUC|Area under the Receiver Operating Characteristic Curve (ROC-AUC) of the PCA3 (Prostate Cancer Antigen 3) to detect difference in PSA decline between cases and controls (non-cases)|Reported at 90 days: assessed at baseline, 30 days, 60 days and 90-day|Receiving biopsy||ratio||95% Confidence Interval|Number
837199|NCT01296672|Primary|Pre/Post Ratio PSA Area Under the Curve (AUC)|Pre/Post Ratio prediction area under the receiver operating characteristics curve (AUC) for subjects taking finasteride 5mg every day for 3 months. Measurements of PSA are measured from Baseline until 3 months.|Reported at 90-days: assessment at baseline, 1 month, 2 months and 3 months|Patients with biopsy||Ratio||95% Confidence Interval|Number
837200|NCT01296698|Secondary|Participant Score for Product Convenience|Participants are asked to rate how convenient the product is to use, on a scale of 1-5, where 1=not at all convenient and 5=extremely convenient.|through 12 Weeks|The study was terminated prematurely due to a technical issue (randomization error) and no data are available.||Units on a scale||Standard Deviation|Mean
837201|NCT01296698|Secondary|Participant Score for Change in Perception|Participants are asked to rate how their opinion has changed since the first time they used it, on a score of 1-5, where 1=I like it much less now and 5=I like it much more now.|through 12 Weeks|The study was terminated prematurely due to a technical issue (randomization error) and no data are available.||Units on a scale||Standard Deviation|Mean
837202|NCT01296698|Secondary|Participant Score for Speed of Action|Participants are asked to rate the product for speed of action, on a scale of 1-9, where 1=extremely slow and 9=extremely fast.|through 12 Weeks|The study was terminated prematurely due to a technical issue (randomization error) and no data are available.||Units on a scale||Standard Deviation|Mean
837203|NCT01296698|Secondary|Participant Score for Product Effectiveness in Dealing With Cravings|Participants are asked to rate the product in its effectiveness for dealing with cravings, on a scale of 1-5, where 1=not at all effective, and 5=extremely effective.|through 12 Weeks|The study was terminated prematurely due to a technical issue (randomization error) and no data are available.||Units on a scale||Standard Deviation|Mean
837204|NCT01296698|Secondary|Participant Score for General Perception of the Product|Participants are asked to rate their general perception of the investigational product on a scale of 1-10, where 1=very poor and 10=excellent.|through Week 12|The study was terminated prematurely due to a technical issue (randomization error) and no data are available.||Units on a scale||Standard Deviation|Mean
837205|NCT01296698|Secondary|Highest Rating of Increased Appetite on a Categorical Scale|Participants are asked if during the last 24 hours they experienced Increased Appetite on a 5-grade categorical scale from Not at all to Extremely so.|within 12 Weeks|Analysis was limited to participants who used study medication at least once and who completed the questionnaire.||Percentage of Participants|||Number
837206|NCT01296698|Secondary|Highest Rating of Insomnia on a Categorical Scale|Participants are asked if during the last 24 hours they experienced Insomnia on a 5-grade categorical scale from Not at all to Extremely so.|within 12 Weeks|Analysis was limited to participants who used study medication at least once and who completed the questionnaire.||Percentage of Participants|||Number
837207|NCT01296698|Secondary|Highest Rating of Dysphoric or Depressed Mood on a Categorical Scale|Participants are asked if during the last 24 hours they experienced Dysphoric or Depressed Mood on a 5-grade categorical scale from Not at all to Extremely so.|within 12 Weeks|Analysis was limited to participants who used study medication at least once and who completed the questionnaire.||Percentage of Participants|||Number
837208|NCT01296698|Secondary|Highest Rating of Anxiety on a Categorical Scale|Participants are asked if during the last 24 hours they experienced Anxiety on a 5-grade categorical scale from Not at all to Extremely so.|within 12 Weeks|Analysis was limited to participants who used study medication at least once and who completed the questionnaire.||Percentage of Participants|||Number
837209|NCT01296698|Secondary|Highest Rating of Difficulty Concentrating on a Categorical Scale|Participants are asked if during the last 24 hours they experienced Difficulty Concentrating on a 5-grade categorical scale from Not at all to Extremely so.|within 12 Weeks|Analysis was limited to participants who used study medication at least once and completed the questionnaire.||Percentage of Participants|||Number
837210|NCT01296698|Secondary|Highest Rating of Restlessness on a Categorical Scale|Participants are asked if during the last 24 hours they experienced Restlessness on a 5-grade categorical scale from Not at all to Extremely so.|within 12 Weeks|Analysis was limited to participants who used study medication at least once and who completed the questionnaire.||Percentage of Participants|||Number
837211|NCT01296698|Secondary|Highest Rating of Irritability/Frustration/Anger on a Categorical Scale|Participants are asked if during the last 24 hours they experienced Irritability/Frustration/Anger on a 5-grade categorical scale from Not at all to Extremely so.|within 12 Weeks|Analysis was limited to participants who used study medication at least once and who completed the questionnaire.||Percentage of Participants|||Number
837212|NCT01296698|Secondary|Highest Rating of Desire/Urge to Smoke on a Categorical Scale|Participants are asked if during the last 24 hours they experienced the Desire/Urge to Smoke on a 5-grade categorical scale from Not at all to Extremely so.|within 12 Weeks|Analysis was limited to participants who used study medication at least once and who completed the questionnaire.||Percentage of Participants|||Number
837213|NCT01296698|Secondary|Percentage of Participants With High Usage|Percentage of participants who used more than four doses in any one-hour period.|within 12 Weeks|Analysis was limited to data collected from participants who had used study medication at least one day.||Percentage of Participants|||Number
837214|NCT01296698|Secondary|Percentage of Participants With High Dosage|Percentage of participants who used more than 64 doses in any one-day period.|within 12 Weeks|Analysis was limited to data collected from participants who had used study medication at least one day.||Percentage of Participants|||Number
837215|NCT01296698|Secondary|Mean Number of Daily Doses|Mean number of daily doses by study week.|Week 6|Analysis was limited to data collected from participants at Week 6. Analysis of data for the remainder of the study weeks was not possible because the trial terminated prematurely due to a technical issue (randomization error).||Daily Doses||Standard Deviation|Mean
837216|NCT01296698|Secondary|Mean Number of Daily Doses|Mean number of daily doses by study week.|Week 5|Analysis was limited to data collected from participants at Week 5.||Daily Doses||Standard Deviation|Mean
837217|NCT01296698|Secondary|Mean Number of Daily Doses|Mean number of daily doses by study week.|Week 4|Analysis was limited to data collected from participants at Week 4.||Daily Doses||Standard Deviation|Mean
837218|NCT01296698|Secondary|Mean Number of Daily Doses|Mean number of daily doses by study week.|Week 3|Analysis was limited to data collected from participants at Week 3.||Daily Doses||Standard Deviation|Mean
837219|NCT01296698|Secondary|Mean Number of Daily Doses|Mean number of daily doses by study week.|Week 2|Analysis was limited to data collected from participants at Week 2.||Daily Doses||Standard Deviation|Mean
837220|NCT01296698|Secondary|Mean Number of Daily Doses|Mean number of daily doses by study week.|Week 1|Analysis was limited to data collected from participants at Week 1.||Daily Doses||Standard Deviation|Mean
837221|NCT01296698|Secondary|Number of Participants With 7-day Point Prevalence Abstinence|Number of participants with carbon monoxide (CO)-verified self-reported 7-day point prevalence abstinence from smoking at Weeks 2, 4, 6, 12, 16, and 26.|through Week 26|The study was terminated prematurely due to a technical issue (randomization error).||Participants|||Number
837222|NCT01296698|Secondary|Number of Participants With Continuous Smoking Abstinence|Number of participants with carbon monoxide (CO)-verified self report of continuous abstinence from smoking from Week 2 to Weeks 4, 6, 12, 16, and 26.|through Week 26|The study was terminated prematurely due to a technical issue (randomization error) and no data are available.||Participants|||Number
837223|NCT01296698|Primary|Number of Participants With Continuous Smoking Abstinence|Number of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking from Week 2 through Week 6.|through Week 6|The study was terminated prematurely due to a technical issue (randomization error) and no data are available.||Participants|||Number
837224|NCT01297062|Secondary|Plasma Exenatide Concentrations at Steady State on Day 1, 2 and 3|The plasma exenatide concentration at steady state was descriptively summarized by geometric mean, standard error, and its effect on placebo-adjusted change from baseline in QTcP was assessed.|Baseline, Day 1, 2, and 3|Evaluable Population. No imputation for missing value was used. Day 1, 2, and 3 exenatide concentration < LLOQ was set to missing.||pg/mL||Standard Error|Geometric Mean
837225|NCT01297062|Secondary|Number of Subjects With Increase of QTcP Interval From Baseline >30msec at Any Timepoint on Any Day in Exenatide and Placebo|Number of subjects with increase of QTcP interval from baseline >30 msec at any timepoint on any day was summarized by frequency for exenatide and placebo.|Baseline, Day 1, 2, or 3|Evaluable Population. No imputation for missing value was used.||particpants|||Number
837226|NCT01297062|Secondary|Number of Subjects With QTcP Interval >450msec at Any Timepoint on Any Day in Exenatide and Placebo|Number of subjects with QTcP > 450 msec at any timepoint on any day was summarized by frequency for exenatide and placebo.|Day 1, 2, or 3|Evaluable Population. No imputation for missing value was used.||participants|||Number
837227|NCT01297062|Secondary|Assay Sensitivity of Moxifloxacin at 1200h (3 Hour Post-administration of Moxifloxacin) on Day 2|Change from baseline in QTcP was analyzed by a MMRM between moxifloxacin and placebo.|Baseline, Day 2|Evaluable Population. No imputation for missing value was used.||msec||90% Confidence Interval|Least Squares Mean
837228|NCT01297062|Secondary|Assay Sensitivity of Moxifloxacin at 1100h (2 Hour Post-administration of Moxifloxacin) on Day 2|Change from baseline in QTcP was analyzed by a MMRM between moxifloxacin and placebo.|Baseline, Day 2|Evaluable Population. No imputation for missing value was used.||msec||90% Confidence Interval|Least Squares Mean
837229|NCT01297062|Secondary|Assay Sensitivity of Moxifloxacin at 1000h (1 Hour Post-administration of Moxifloxacin) on Day 2|Change from baseline in QTcP was analyzed by a MMRM between moxifloxacin and placebo.|Baseline, Day 2|Evaluable Population. No imputation for missing value was used.||msec||90% Confidence Interval|Least Squares Mean
837230|NCT01297062|Primary|Comparison of LS Mean Changes From Baseline in QTcP Intervals Between Exenatide and Placebo on Day 3 Averaged Over 1300h, 1400h, 1500h (Target Steady State Exenatide Concentration of 500 pg/mL)|Factors in QT correction formulas were first estimated using pre-therapy data. The most appropriate correction method (QTcP) minimized the mean squared individual QTc/RR regression slope with on-exenatide data. Adequacy of correction was validated with on-placebo data. Change from baseline in QTcP was analyzed by a MMRM between exenatide and placebo.|Baseline, Day 3|Evaluable Population. No imputation for missing value was used.||msec||90% Confidence Interval|Least Squares Mean
837231|NCT01297062|Primary|Comparison of LS Mean Changes From Baseline in QTcP Intervals Between Exenatide and Placebo on Day 2 Averaged Over 1300h, 1400h, 1500h (Target Steady State Exenatide Concentration of 300 pg/mL)|Factors in QT correction formulas were first estimated using pre-therapy data. The most appropriate correction method (QTcP) minimized the mean squared individual QTc/RR regression slope with on-exenatide data. Adequacy of correction was validated with on-placebo data. Change from baseline in QTcP was analyzed by a MMRM between exenatide and placebo.|Baseline, Day 2|Evaluable Population. No imputation for missing value was used.||msec||90% Confidence Interval|Least Squares Mean
837232|NCT01297062|Primary|Comparison of Least Squares (LS) Mean Changes From Baseline in Population-based Corrected QT Intervals (QTcP) Between Exenatide and Placebo on Day 1 Averaged Over 1300h, 1400h, 1500h (Target Steady State Exenatide Concentration of 200 pg/mL)|Factors in QT correction formulas were first estimated using pre-therapy data. The most appropriate correction method (QTcP) minimized the mean squared individual QTc/RR regression slope with on-exenatide data. Adequacy of correction was validated with on-placebo data. Change from baseline in QTcP was analyzed by a mixed-effects model for repeated measures (MMRM) between exenatide and placebo.|Baseline, Day 1|Evaluable Population included all ITT subjects who completed all ECG assessment periods and have valid ECG measurements and no vomiting in any ECG data extraction window. No missing value was imputed.||msec||90% Confidence Interval|Least Squares Mean
837233|NCT01297257|Secondary|In-hospital MACE (Major Adverse Cardiac Event)||stent implantation until hospital discharge (average 1-3 days)|||Participants|||Number
837234|NCT01297257|Primary|Delivery Success|The primary endpoint for this study is delivery success defined as complete passage of the Resolute Integrity stent across the target lesion with full expansion of the stent to the desired diameter at the desired location.|stent implantation until hospital discharge (average 1-3 days)|||stents|Participants||Number
837235|NCT01297270|Secondary|AST Normalisation: AST in Normal Range 12 Weeks Post-treatment, When SVR12=NO|The number of participants with aspartate aminotransferase (AST) in normal range 12 weeks post-treatment when patients do not have sustained virological response 12 weeks post-treatment. BL = Baseline|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.||participants|||Number
837236|NCT01297270|Secondary|AST Normalisation: AST in Normal Range 12 Weeks Post-treatment, When SVR12=YES|The number of participants with aspartate aminotransferase (AST) in normal range 12 weeks post-treatment when patients have sustained virological response 12 weeks post-treatment. BL = Baseline|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.||participants|||Number
837237|NCT01297270|Secondary|AST Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO|The number of participants with aspartate aminotransferase (AST) in normal range at the end of treatment when patients do not have sustained virological response 12 weeks post-treatment. BL = Baseline|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.||participants|||Number
837238|NCT01297270|Secondary|AST Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES|The number of participants with aspartate aminotransferase (AST) in normal range at the end of treatment when patients have sustained virological response 12 weeks post-treatment. BL = Baseline|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.||participants|||Number
837239|NCT01297270|Secondary|ALT Normalisation: ALT in Normal Range 12 Weeks Post-treatment, When SVR12=NO|The number of participants with alanine aminotransferase (ALT) in normal range 12 weeks post-treatment when patients do not have sustained virological response 12 weeks post-treatment. BL = Baseline|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.||participants|||Number
837240|NCT01297270|Secondary|ALT Normalisation: ALT in Normal Range 12 Weeks Post-treatment, When SVR12=YES|The number of participants with alanine aminotransferase (ALT) in normal range 12 weeks post-treatment when patients have sustained virological response 12 weeks post-treatment. BL = Baseline|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.||participants|||Number
837241|NCT01297270|Secondary|ALT Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO|The number of participants with alanine aminotransferase (ALT) in normal range at end of treatment (EOT) when patients do not have sustained virological response 12 weeks post-treatment. BL = Baseline|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.||participants|||Number
837242|NCT01297270|Secondary|ALT Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES|The number of participants with alanine aminotransferase (ALT) in normal range at end of treatment (EOT) when patients have sustained virological response 12 weeks post-treatment. BL = Baseline|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.||participants|||Number
837243|NCT01297270|Secondary|Early Treatment Success (ETS)|Percentage of participants with early treatment success (ETS), defined as a plasma HCV RNA level <25 IU/mL (detected or undetected) at week 4 and HCV RNA <25 IU/mL (undetected) at week 8.|Week 4 and week 8|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.||percentage of participants|||Number
837244|NCT01297270|Secondary|Sustained Virologic Response 24 Weeks Post-treatment (SVR24)|"Percentage of participants with sustained virologic response 24 weeks post-treatment (SVR24), defined as plasma HCV RNA level < 25 IU/mL (undetected) 24 weeks after the originally planned treatment duration.
Hepatitis C virus Ribonucleic acid (HCV RNA)"|24 weeks post treatment, up to 72 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication and had SVR data at week 24.||percentage of participants||95% Confidence Interval|Number
837245|NCT01297270|Primary|Sustained Virologic Response 12 Weeks Post Treatment (SVR12)|Percentage of participants with sustained virologic response 12 weeks post treatment (SVR12) defined as plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level<25 IU/mL (undetected) 12 weeks after the originally planned treatment duration.|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.||percentage of participants||95% Confidence Interval|Number
837246|NCT01297283|Secondary|Evaluation of Factors Such as Device Rotation, Device Fixation, Device Side Facing the Skin, Position of Lead Loops in the Pocket, Use of Antiseptic Solution, Skin Type, Body Mass Index on the Quality of Leadless ECG.|"The following factors will be evaluated to investigate whether they influence the LECG quality:
device position (subcutaneous, submuscular, etc)
device rotation
device fixation
device side facing the skin
position of lead loops in the pocket
use of antibiotics in the pocket
skin type (loose, normal, firm)
body mass index (BMI)
The endpoints will be:
describe R wave amplitude values
describe proportion of patients with P wave visible on intrinsic LECG strips recorded at 1-Month FU."|30 to 120 days||||||
837247|NCT01297283|Secondary|Effect of Posture Changes and Artifact-inducing Maneuvers on the LECG Quality.|"The intrinsic R wave amplitude and P waves visibility will be taken to evaluate the effect of posture changes and artifact-inducing maneuvers on the quality of LECG at the 1-Month Follow-Up visit (LECG vector with best combination of the highest R wave and most visible P wave).
The endpoints will be R wave amplitude and P wave visibility in different positions (meaning visible or not visible in both positions).
R wave changes and proportion of patients with stable P waves visibility at lying position versus other positions will be calculated by an independent reviewer."|30 to 120 days||||||
837248|NCT01297283|Secondary|Quality of LECG in New Devices Versus Device Replacements.|"The two following parameters will be used to compare the quality of LECG in new implants versus device replacements at PHD and 1-Month on the same LECG vector:
Intrinsic R wave amplitude
P waves visibility The LECG vector at PHD with best combination of the highest R wave and most visible P wave will be selected.
R wave amplitude measurements as well as P wave visibility assessment will be done by the independent reviewer.
The endpoints will be:
comparison of mean R wave values at PHD and 1-month
comparison of proportion of patients with P wave visible at PHD and 1-month."|30 to 120 days||||||
837249|NCT01297283|Secondary|Evaluation of the Stability of LECG Performance Over Time.|"Two parameters will be used to evaluate LECG changes between PHD and 1-Month on the same LECG vector: intrinsic R wave amplitude and P waves visibility (selection the LECG vector at PHD with best combination of the highest R wave and most visible P wave).
R wave amplitude measurements as well as P wave visibility assessment will be done by the independent reviewer.
The endpoints evaluated are:
mean R wave changes from PHD to 1-month
proportion of patients with stable P wave visibility at PHD and 1-Month (meaning both visits visible or both visits not visible)."|30 to 120 days||||||
837250|NCT01297283|Secondary|Evaluation of the Possibility to Determine Ventricle Capture by an Independent Reviewer.|"The investigator will simulate loss of capture (LOC) at 1-Month Follow-Up visit by printing strips of LOC in both ventricular leads, LOC in LV lead only, LOC in RV lead only, no LOC. One strip randomly selected among them by the study manager will be submitted to an independent reviewer. With help of the PHD template LECG strips (intrinsic, RV paced, LV paced, BiV paced) of this patient, he/she will determine which lead is capturing.
The endpoint is the proportion of correct classifications of ventricular capture done by then independent reviewer of LECG."|30 to 120 days|Proportion of Patients Correctly Classified||proportion||95% Confidence Interval|Number
837251|NCT01297283|Primary|Proportion of Patients With LECG Performing Clinically Equivalent to PECG During Standard Pacemaker Follow-up Procedure.|During CRT-P standard follow-up, ECG is used to determine atrial, left and right ventricular pacing thresholds. As primary endpoint, we will consider the proportion of patients for which for all leads LECG provides pacing threshold values that are clinically equivalent to those obtained with PECG taken as reference. The analysis will be performed on data collected at the 1-Month Follow-Up visit when the device pocket healing process is completed. Clinical equivalence will be defined as the LECG threshold values being no more than 0.5 volts different from the PECG threshold values.|30 to 120 days|||proportion||95% Confidence Interval|Number
837252|NCT01297322|Secondary|Rate of Combined Minor Access Site Complications|"Secondary safety endpoint
Access site-related bleeding requiring greater than 30 minutes to achieve hemostasis;
Access site-related hematoma > 6 cm;
Late access site-related bleeding (following hospital discharge);
Ipsilateral lower extremity arterial emboli;
Ipsilateral deep vein thrombosis;
Access site-related vessel laceration;
Access site wound dehiscence;
Localized access site infection treated with intramuscular or oral antibiotics;
Arteriovenous fistula not requiring treatment;
Pseudoaneurysm requiring thrombin injection or fibrin adhesive injection;
Pseudoaneurysm not requiring treatment;
New onset access site-related neuropathy in the ipsilateral lower extremity not requiring surgical repair;
Ipsilateral pedal pulse diminished by two grades or transiently lost."|30 days +/- 7 days|||participants|||Number
837253|NCT01297322|Secondary|Procedure Success|Secondary effectiveness endpoint - attainment of final hemostasis using any method and freedom from major vascular complications through 30 days|30 days +/- 7 days|||participants|||Number
837254|NCT01297322|Secondary|Device Success|Secondary effectiveness endpoint - ability to deploy the delivery system, deliver the collagen, and achieve hemostasis with VASCADE alone or with adjunctive compression|Up to 1 day|||participants|||Number
837255|NCT01297322|Secondary|Time to Hospital Discharge (TTHD)|Secondary effectiveness endpoint - elapsed time between device (VASCADE) or sheath (manual compression) removal and when subject is actually discharged from the hospital|Up to 2 days|||hours||Standard Deviation|Mean
837256|NCT01297322|Secondary|Time to Discharge Eligibility (TTDE)|Secondary effectiveness endpoint - elapsed time between device (VASCADE) or sheath (manual compression) removal and when subject is medically able to be discharged based solely on the assessment of the access site, as determined by the medical team|Up to 2 days|||hours||Standard Deviation|Mean
837257|NCT01297322|Secondary|Time to Ambulation (TTA)|Secondary effectiveness endpoint - elapsed time between device (VASCADE) or sheath (manual compression) removal and when subject stands and walks 20 feet without evidence of arterial re-bleeding|Up to 1 day|||hours||Standard Deviation|Mean
837258|NCT01297322|Primary|Rate of Combined Access Site-related Major Complications|"Primary safety endpoint
Access site-related bleeding requiring transfusion;
Vascular injury requiring repair (via surgery, ultrasound guided compression, transcatheter embolization or stent graft);
New ipsilateral lower extremity ischemia causing a threat to the viability of the limb and requiring surgical or additional percutaneous intervention. This compromised blood flow is documented by subject symptoms, physical exam and/or a decreased or absent blood flow on lower extremity angiogram.;
Access site-related infection requiring intravenous antibiotics and/or extended hospitalization;
New onset access site-related neuropathy in the ipsilateral lower extremity requiring surgical repair;
Permanent access site-related nerve injury. (> 30 days)"|30 days +/- 7 days|||participants|||Number
837260|NCT01297335|Secondary|Changes in Visual Analogue Scale (VAS) Ratings of Sedation and Sensation of Dry Mouth Reported by the Subjects, Pre and 1 Hour Post Injection|Subjects were asked to rate severity of two of the most common side effects of clonidine, sedation and sensation of dry mouth, at pre and post (1 hour after) intrathecal administration of clonidine. The mean changes between pre and post injection VAS ratings of sedation and sensation of dry mouth are reported below. The VAS scale ranges from 1 to 10 cm, with higher values indicating higher level of sedation and higher level of dry mouth.|Before clonidine injection (Baseline), and at 1 hour after clonidine injection.|All qualified subjects were given intrathecal clonidine and were asked to rate level of sedation and sensation of dry mouth before clonidine injection (baseline) and 1 hour post injection on VAS scale.||cm||Standard Deviation|Mean
837261|NCT01297335|Secondary|Likert Scale Pain Rating|Likert scale is 11 point digital pain rating system that asks subjects to rate their pain from 0 to 10. Rating of 0 means no pain at all, and in increasing order, 10 would mean worst pain imaginable/ unbearable pain.|Pre-dose and 1 hour post injection.|All subjects met inclusion and exclusionary criteria, and received intrathecal injection of clonidine. Subjects were asked to rate their baseline pain on Likert scale prior to receiving intrathecal clonidine injection, and 1 hour post intrathecal clonidine injection.||units on a scale||Standard Deviation|Mean
837262|NCT01297335|Primary|Change in Blood Pressure After Intrathecal Injection of Clonidine.|"Subjects baseline blood pressure (systolic blood pressure (SBP), and diastolic blood pressure (DBP)), and blood pressures after clonidine injection was compared against baseline to assess efficacy of clonidine in refractory hypertensive subjects. Subject's blood pressure was monitored continuously after intrathecal injection of clonidine until subjects blood pressure nadir and return to pre clonidine injection level. The mean value reported below are the average changes in blood pressure from baseline (pre clonidine injection) in both SBP and DBP during post clonidine injection blood pressure monitoring for 4 hours.
Blood pressure measurements were collected every 10 minutes for first hour after injection, and every 15 minutes after the first hour, up to 4 hours were averaged to report the change from baseline."|Baseline, Every 10 Minutes for first hour after clonidine injection, and every 15 minutes after first hour, until 4 hours after clonidine injection|All subjects met inclusion and exclusionary criteria, and was given an intrathecal injection of clonidine. They were followed for changes in blood pressure for 4 hours.||mm Hg||Standard Deviation|Mean
837263|NCT01297348|Primary|Number of Idiopathic Venous Thromboembolism (VTE) Cases and Matched Controls|Idiopathic VTE cases=new DVT, PE or CVST occurring in absence of known risk factors. Matched Control was defined as participants with no diagnosis of VTE matched for age, calendar time, exposure status and database. Current user=had claim for study OC prescription (Lybrel or other OCs containing ethinyl estradiol 20 mcg) whose filled use occurred within 30 days prior to or at index date. Past user=had claim for a study OC prescription whose filled use occurred between 90 to 31 days prior to index date. Index date=date of VTE diagnosis for case and corresponding date for matched control.|Index date (date of VTE diagnosis for case and corresponding date for matched control)|Analysis population included all enrolled participants who met the eligibility criteria.||participants|||Number
837264|NCT01297348|Primary|Incidence Rate of Idiopathic Venous Thromboembolism (VTE)|Idiopathic VTE=deep vein thrombosis (DVT), pulmonary embolism (PE), or cerebral venous sinus thrombosis (CVST) occurring in absence of known risk factors. Incidence rate reported for current, past users. Current user=had claim for study OC prescription (Lybrel or other OCs containing ethinyl estradiol 20 mcg) whose filled use occurred within 30 days prior to or at index date. Past user=had claim for a study OC prescription whose filled use occurred between 90 to 31 days prior to index date. Index date=date of VTE diagnosis for case and corresponding date for matched control.|Index date (date of VTE diagnosis for case and corresponding date for matched control)|Analysis population included all enrolled participants who met the eligibility criteria.||incidence rate per 100000 person-years|||Number
837265|NCT01297465|Secondary|Heart Rate Assessments||Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])|"Safety Population included all the randomized participants who had received at least 1 dose of Pergoveris® or Gonal-f®. .N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure."||beats per minute (bpm)||Standard Deviation|Mean
837266|NCT01297465|Secondary|Systolic and Diastolic Arterial Blood Pressure Assessments||Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])|"Safety Population included all the randomized participants who had received at least 1 dose of Pergoveris® or Gonal-f®. .N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure."||millimeter of mercury ( mm Hg)||Standard Deviation|Mean
837267|NCT01297465|Secondary|Number of Participants With Treatment-emergent Adverse Events|An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.|Day 1 up to days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])|Safety Population included all the randomized participants who had received at least 1 dose of Pergoveris® or Gonal-f®.||participants|||Number
837268|NCT01297465|Secondary|Number of Participants With Early and Late Ovarian Hyper Stimulation Syndrome (OHSS)|Ovarian Hyper Stimulation Syndrome (OHSS) is a syndrome which can manifest with enlarged ovaries, advanced ascites with increased vascular permeability, pleural fluid accumulation, hemoconcentration, and increased blood clotting. Early OHSS was defined as the onset of OHSS occurring within 9 days after oocyte retrieval and late OHSS was defined as the onset of OHSS occurring on or after day 10 from oocyte retrieval.|Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])|Safety Population included all the randomized participants who had received at least 1 dose of Pergoveris® or Gonal-f®.||participants|||Number
837269|NCT01297465|Secondary|Number of Participants With Multiple Pregnancies|Multiple pregnancy was defined as the existence of more than one fetal sac with fetal heart activity.|Days 35-42 post r-hCG day (end of stimulation cycle [approximately 11 days])|"Mod-ITT population included all the randomized participants who had received at least one dose of GONAL-f® or Pergoveris®, and completed the primary efficacy assessment. N (number of participants analyzed) signifies those participants who had their embryo transfer in study treatment cycle."||participants|||Number
837270|NCT01297465|Secondary|Biochemical Pregnancies Rate|Biochemical pregnancy was defined as the pregnancy diagnosed only by the detection of human chorionic gonadotropin (hCG) in serum or urine and that does not develop into a clinical pregnancy. Participants with beta- hCG concentration greater than 10 international units per liter (IU/L) were considered as biochemical pregnant.|Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])|"Mod-ITT population included all the randomized participants who had received at least one dose of GONAL-f® or Pergoveris®, and completed the primary efficacy assessment. . N (number of participants analyzed) signifies those participants who had their embryo transfer in study treatment cycle."||participants|||Number
837271|NCT01297465|Secondary|Number of Participants With Cancelled Cycles Due to Excessive or Insufficient Ovarian Response to Treatment|An excessive ovarian response: greater than or equal to 25 oocytes which could put the participant at risk of OHSS; An insufficient ovarian response: defined as 3 or less follicles of greater than or equal to 12 millimeter developing following at least 7 days of treatment.|S1 until Day 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])|Safety Population included all the randomized participants who had received at least 1 dose of Pergoveris® or Gonal-f®.||participants|||Number
837272|NCT01297465|Secondary|Clinical Pregnancy Rate|Clinical pregnancy was defined as pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It includes ectopic pregnancy. Clinical pregnancy rate was reported as total clinical pregnancy rate, clinical pregnancy rate per cycle started and per embryo transfer [ET]).|Days 35-42 post r-hCG day (end of stimulation cycle [approximately 11 days])|"Mod-ITT population included all the randomized participants who had received at least one dose of GONAL-f® or Pergoveris®, and had completed the primary efficacy assessment. N signifies those participants who had their ET in study treatment cycle. n signifies those participants who were evaluated for this measure in specified categories."||percentage of participants|||Number
837273|NCT01297465|Secondary|Number of Fetal Hearts With Activity|Number of fetal hearts with activity was evaluated by ultrasound scan|Days 35-42 post r-hCG day [end of stimulation cycle {approximately 11 days}])|"Mod-ITT population included all the randomized participants who had received at least one dose of GONAL-f® or Pergoveris®, and completed the primary efficacy assessment.N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure."||fetal hearts||Standard Deviation|Mean
837274|NCT01297465|Secondary|Number of Fetal Sacs With Activity|Number of fetal sacs with activity was evaluated by ultrasound scan|Days 35-42 post r-hCG day [end of stimulation cycle {approximately 11 days}])|"Mod-ITT population included all the randomized participants who had received at least one dose of GONAL-f® or Pergoveris®, and completed the primary efficacy assessment.N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure."||fetal sacs||Standard Deviation|Mean
837275|NCT01297465|Secondary|Implantation Rate|Implantation rate per reporting group was measured as the number of fetal sacs observed, divided by the number of embryos transferred multiplied by 100.|Days 35-42 post r-hCG day (end of stimulation cycle [approximately 11 days])|Mod-ITT population included all the randomized participants who had received at least one dose of GONAL-f® or Pergoveris®, and completed the primary efficacy assessment.||percent sacs per embryo||Standard Deviation|Mean
837276|NCT01297465|Secondary|Total Number of Stimulation Treatment Days||Day 1 up to r-hCG day (end of stimulation cycle [approximately 11 days])|Safety Population included all the randomized participants who had received at least 1 dose of Pergoveris® or Gonal-f®.||days||Standard Deviation|Mean
837277|NCT01297465|Secondary|Total Dose and Mean Daily Dose of Follicle Stimulating Hormone (FSH)||Day 1 up to r-hCG day (end of stimulation cycle [approximately 11 days])|Safety Population included all the randomized participants who had received at least 1 dose of Pergoveris® or Gonal-f®.||IU||Standard Deviation|Mean
837278|NCT01297465|Primary|Total Number of Oocytes Retrieved|The total number of oocytes retrieved per reporting group on the day of ovum pick-up (OPU) (34-38 hours post r-hCG day) was calculated. Oocyte retrieval is a technique used in in-vitro fertilization (IVF) in order to remove oocytes from the ovary of the female participant, enabling fertilization outside the body.|OPU day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 11 days}])|Modified intention-to-treat (Mod-ITT) population included all the randomized participants who had received at least one dose of GONAL-f® or Pergoveris®, and completed the primary efficacy assessment.||oocytes||Standard Deviation|Mean
837279|NCT01297491|Secondary|Duration of Response (DoR)|DoR was defined as the elapsed time between the date of first documented CR or PR response (not the date of confirmed response) and the following date of event defined as the first documented progression or death due to underlying cancer.|Every 6 weeks up to 24 months|Analysis set Stage 1 includes all patients who were enrolled during Stage 1 after meeting eligibility criteria and who have received at least 1 dose of study drug. 1 partial response was observed as best overall response (BOR) for 1 patient in the squamous group. Also,1 patient experienced partial response as BOR in the non-squamous group.||Days|||Number
837280|NCT01297491|Secondary|Time to Response (TTR)|TTR for a participant was defined as the time from the first treatment date to the date of first documented confirmed CR or PR evaluation. The date of event was defined as the date of response that was first determined and not using the date the response was confirmed.|Every 6 weeks up to 24 months|Analysis set Stage 1 includes all patients who were enrolled during Stage 1 after meeting eligibility criteria and who have received at least 1 dose of study drug. 1 partial response was observed as best overall response (BOR) for 1 patient in the squamous group. Also,1 patient experienced partial response as BOR in the non-squamous group.||Days|||Number
837281|NCT01297491|Secondary|Disease Control Rate (DCR)|"DCR defined as the percentage of participants with best overall response of CR or PR or stable disease (SD). Complete response was defined as disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm. Partial response was defined as at least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD.
Analyses of response rates were performed based on investigators’ assessments (as per RECIST 1.1 criteria). DCR included all participants with and without measurable disease at baseline."|Every 6 weeks up tp 24 months|Analysis set Stage 1 includes all patients who were enrolled during Stage 1 after meeting eligibility criteria and who have received at least one dose of study drug.||Percentage of participants|||Number
837282|NCT01297491|Secondary|Overall Response Rate (ORR) Based on Investigator Assessment|ORR was defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR). Complete response was defined as disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm. Partial response was defined as at least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. Analyses of response rates were performed based on investigators’ assessments (as per RECIST 1.1 criteria). ORR included all patients with and without measurable disease at baseline.|Every 6 weeks up to 24 months|Analysis set Stage 1 includes all patients who were enrolled during Stage 1 after meeting eligibility criteria and who have received at least one dose of study drug.||Percentage of participants|||Number
837283|NCT01297491|Secondary|Overall Survival (OS) Using Kaplan-Meier Estimates|OS was defined as the time from start of study drug (Stage 1) until death from any cause. If a patient was not known to have died, survival was censored at the date of last contact.|Every 8 weeks up to 24 months|Analysis set Stage 1 includes all patients who were enrolled during Stage 1 after meeting eligibility criteria and who have received at least one dose of study drug.||Months||95% Confidence Interval|Median
837284|NCT01297491|Primary|Progression Free Survival (PFS) Rate as Per Investigator Local Review Measured Using RECIST 1.1 of Patients at Week 12|"PFS rate was defined as the percentage of participants who were progression free at 12 weeks. Participants were considered as a success for PFS rate evaluated at 12 weeks if they presented an overall response at their 2nd post-baseline tumor assessment.The enrollment into the study in either histology group would stop for futility if a PFS rate <50% at 12 weeks was observed.
No statistical analysis was planned for this primary outcome. The results of the primary objective was based on the data from the interim analysis that took place at the cut off dates: 10-Apr-2013 for non-squamous and 08-Jan-2014 for squamous group."|Week 12|Analysis set Stage 1 includes all patients who were enrolled during Stage 1 after meeting eligibility criteria and who have received at least one dose of study drug.||Percentage of participants||95% Confidence Interval|Number
837285|NCT01297504|Secondary|Mean Number of Doses of Palivizumab Administered||12 months|||doses||Standard Deviation|Mean
837286|NCT01297504|Primary|Distribution of Comorbidities in Study Participants|The percentage of participants with each and combinations of the three comorbidities for which palivizumab is indicated.|Baseline|||percentage of participants|||Number
837287|NCT01297504|Secondary|Compliance to Prescribed Palivizumab|Compliance to prescribed palivizumab was calculated based on the number of doses received versus the expected number of doses for each participant. The expected number of doses for each participant was estimated based on seasonality and current prescription guidelines for each country.|12 months|||Percentage of expected dose||95% Confidence Interval|Number
837288|NCT01297504|Secondary|Risk Factors for Hospitalization|Variables that could act as risk factors for hospitalization for lower respiratory tract infection were tested in univariate and multivariate Poisson regression models. Baseline characteristics, such as age, gender, birth weight and comorbidities were included as covariates in the Poisson regression model. Variables for multivariate analysis were added applying forward selection. Gestational age and birth weight were included as continuous variables, considering that the higher they were the better they could act as a protection factor for hospitalization due to respiratory infection.|Baseline and 12 months|||rate ratio||95% Confidence Interval|Number
837289|NCT01297504|Secondary|Characterization of Hospitalization Episodes Due to Lower Respiratory Tract Infection and RSV||12 months|Participants with hospitalization due to LTRI and hospitalization due to LTRI and RSV.||hospitalization episodes|Participants||Number
837290|NCT01297504|Secondary|Number of Participants With Hospitalizations for Lower Respiratory Tract Infection and RSV|The number of participants with hospitalizations due to lower respiratory tract infection (LRTI) and hospitalizations due to lower respiratory tract infection caused by RSV.|12 months|||participants|||Number
837291|NCT01297504|Primary|Characterization of Participants With Risk Factors for Respiratory Syncytial Virus (RSV) Infection|Study participants were characterized at Baseline by history of bronchopulmonary dysplasia, history of prematurity (less than or equal to 35 weeks gestational age), children with hemodynamically significant congenital heart disease (CHD), the presence of cohabitants less than 6 years old, possible exposure to indoor tobacco smoke, day care attendance, asthmatic or atopic mother, smoking during pregnancy, breastfeeding, prenatal assistance (4 or more visits during pregnancy), neonatal hospitalization care, history of neonatal assisted ventilation, and mother education level (completed primary school).|Baseline|||participants|||Number
837292|NCT01297517|Primary|Mean IOP at Month 3 for Each Assessment Timepoint (8 AM, + 2 h, + 7 h, and + 9 h)|At the Month 3 (Exit) visit, the 8 am IOP measurement was taken before instillation of study drug. The study drug was instilled approximately 15 minutes after the 8 am measurement. An additional dose was given at 3 pm. Intraocular pressure was measured by Goldmann applanation tonometry. One eye from each patient was chosen as the study eye and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).|Month 3|Intent-to-treat (ITT): All patients who received study medication and completed at least 1 scheduled on-therapy study visit. Observed case analysis of the ITT dataset, per randomized treatment assignment.||millimeters mercury (mm Hg)||Standard Error|Least Squares Mean
837293|NCT01297595|Secondary|Metabolite to Parent Ratio of Area Under the Curve From Time Zero to Infinite Time [MRAUC (0- ∞)]|Molar ratio of metabolite to parent area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0- ∞) [MRAUC (0- ∞)].|0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. ‘N’ = Number of participants contributing to the mean.||Ratio||Standard Deviation|Geometric Mean
837294|NCT01297595|Secondary|Metabolite to Parent Ratio of Area Under the Curve From Time Zero to Last Quantifiable Concentration (MRAUClast)|Molar ratio of metabolite to parent area under the plasma concentration time-curve from time zero (pre-dose) to the last measured concentration (MRAUClast).|0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||Ratio||Standard Deviation|Geometric Mean
837295|NCT01297595|Secondary|Metabolite to Parent Ratio of Maximum Observed Plasma Concentration (MRCmax)|Metabolite (PF-06260182) to parent (crizotinib) molar ratio of maximum observed plasma concentration (MRCmax).|0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||Ratio||Standard Deviation|Geometric Mean
837296|NCT01297595|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) for Crizotinib Metabolite (PF-06260182)||0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||hr||Full Range|Median
837297|NCT01297595|Secondary|Maximum Observed Plasma Concentration (Cmax) for Crizotinib Metabolite (PF-06260182)||0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng/mL||Standard Deviation|Geometric Mean
837298|NCT01297595|Secondary|Area Under the Curve From Time Zero to Infinite Time [AUC (0 - ∞)] for Crizotinib Metabolite (PF-06260182)|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞) of crizotinib metabolite (PF-06260182).|0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. ‘N’ = Number of participants contributing to the mean.||ng*hr/mL||Standard Deviation|Geometric Mean
837299|NCT01297595|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Crizotinib Metabolite (PF-06260182)|Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast) of Crizotinib metabolite (PF-06260182).|0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng*hr/mL||Standard Deviation|Geometric Mean
837300|NCT01297595|Secondary|Apparent Volume of Distribution (Vz/F)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||Liter||Standard Deviation|Geometric Mean
837301|NCT01297595|Secondary|Apparent Oral Clearance (CL/F)|Drug clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the plasma. Clearance obtained after oral dose (apparent oral clearance [CL/F]) is influenced by the fraction of the dose absorbed (F).|0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||Liter/hour (L/hr)||Standard Deviation|Geometric Mean
837302|NCT01297595|Secondary|Plasma Terminal Half-Life (t1/2)|Plasma terminal half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||hr||Standard Deviation|Mean
837303|NCT01297595|Secondary|Maximum Observed Plasma Concentration (Cmax)||0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng/mL||Standard Deviation|Geometric Mean
837304|NCT01297595|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast).|0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng*hr/mL||Standard Deviation|Geometric Mean
837305|NCT01297595|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||hr||Full Range|Median
837306|NCT01297595|Primary|Area Under the Curve From Time Zero to Infinite Time [AUC (0 - ∞)]|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hours (hrs) post crizotinib dose|Pharmacokinetic (PK) parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng*hr/mL||Standard Deviation|Geometric Mean
837307|NCT01297920|Primary|Mean Intraocular Pressure (IOP) at Each Assessment Timepoint (8 AM, +2 h, +7 h, and +9 h) at Month 3|The study drug was instilled at 8 AM and 3 PM (approximately 15 minutes after conducting the IOP measurements). Intraocular pressure was measured by Goldmann applanation tonometry. One eye from each patient was chosen as the study eye and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).|Month 3|Intent-to-Treat (ITT): All subjects who received study medication and completed at least 1 scheduled on-therapy study visit. Observed case analysis of the ITT dataset, per randomized treatment assignment.||millimeters mercury (mm HG)||Standard Error|Least Squares Mean
837539|NCT01305239|Secondary|Duration of Treatment|Total duration of adjuvant hormonal therapy with exemestane.|Baseline, every 6 months until adjuvant hormonal therapy stopped or up to 5 years of therapy completed|Safety set; N = number of participants with analyzable (non-missing) data. For 2 participants lost to follow-up, the duration of exemestane was calculated until the date of lost to follow-up.||months||Standard Deviation|Mean
837308|NCT01298063|Secondary|Clinical Relevant Abnormalitites for Physical Examination, Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Adverse Event, Investigator's Global Tolerability|Clinical relevant abnormalitites for physical examination, vital signs, 12-lead electrocardiogramm (ECG), clinical laboratory test (including hematology, clinical chemistry, coagulation, urinalysis), adverse event, investigator's global tolerability. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.|First administration of trial medication until 28 days after last administration of trial medication|Treated set||participants|||Number
837309|NCT01298063|Secondary|Area Under Curve From 0 to tz (AUC0-tz)|AUC0-tz represents the area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point|30 minutes (min) prior to first dosing and 30 min, 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 8 h, 9 h, 12 h, 24 h, 36 h, 48 h, 72 h, 96 h, 120 h, 144 h, 168 h, 240 h after first dosing|PK analysis set. Group B1 was not included in the primary analysis set for comparison.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
837310|NCT01298063|Primary|Maximum Concentration (Cmax)|Cmax represents the maximum measured concentration of the analyte in plasma|30 minutes (min) prior to first dosing and 30 min, 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 8 h, 9 h, 12 h, 24 h, 36 h, 48 h, 72 h, 96 h, 120 h, 144 h, 168 h, 240 h after first dosing|PK analysis set. Group B1 was not included in the primary analysis set for comparison.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
837311|NCT01298063|Primary|Area Under Curve From 0 to Infinity (AUC0-infinity)|AUC0-infinity represents the area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity|30 minutes (min) prior to first dosing and 30 min, 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 8 h, 9 h, 12 h, 24 h, 36 h, 48 h, 72 h, 96 h, 120 h, 144 h, 168 h, 240 h after first dosing|Pharmacokinetic (PK) analysis set includes all evaluable matched subjects in the treated set providing at least 1 observation for at least 1 PK endpoint without important protocol violations. Group B1 was not included in the primary analysis set for comparison.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
837312|NCT01298128|Primary|Incidence of Side Effects of Oral Contraceptives Such as Abnormal Bleeding, Headache, Breast Discomfort, Bloating and Mood Swings (See Description)|abnormal bleeding, intermittent bleeding, headache, breast discomfort, bloating, mood swings, nausea, vaginal discharge, vomitting, weight gain|patients were followed for the duration of an in-vitro fertilization cycle- 2 months|70 patients were recruited and randomized. 53 patients completed the study. 11 patients did not then undergo an ivf cycle after recruitment. 6 patients withdrew from the study after recruitment.||participants|||Number
837313|NCT01298167|Primary|Visual Analog Scale (VAS)|"The Visual Analog or Analogue Scale (VAS)* is designed to present to the respondent a rating scale with minimum constraints. Respondents mark the location on the 10-centimeter line corresponding to their feeling. It also gives the maximum opportunity for each respondent to express a personal response style.
The scale is interpreted as the greater the scale score (as the score approaches 10), the greater the cosmetic and functional outcome of the healed wound.
Aitken, R. C. B. (1969). Measurement of feelings using visual analogue scales. Proceedings of the Royal Society of Medicine. 62, 989 - 993
Freyd, M. (1923). The graphic rating scale. Journal of Educational Psychology, 43, 83 - 102
Hayes, M. H. S. & D. G. Patterson (1921). Experimental development of the graphic rating method. Psychological Bulletin, 18, 98-99"|3 months|Individuals' wounds were divided in half and then treated with both Cyanoacrylate and Fast Absorbing Gut Suture. Individuals were randomized as to which half of the wound (superior or inferior) would be treated by each of the methods.||units on a scale||Standard Deviation|Mean
837314|NCT01298323|Primary|Percentage of Time a Patient Experienced at Least 1 AE of CTCAE Grade >=2 in First 12 Months of Receiving Vandetanib in Patients Who Participated in Patient Outreach Program.|The primary endpoint is the percentage of time a patient experienced at least one AE of CTCAE grade 2 or higher in the first 12 months of treatment with vandetanib. If the patient discontinues treatment with vandetanib prior to the 12-month time point for any reason, this endpoint will be the time a patient experienced at least one AE of CTCAE grade 2 or higher as a percentage of the time the patient was receiving vandetanib.|12 months|Number of Months Analyzed is the cumulative sum of number of months that all the participants were present in the study.||Percentage of days|months|Standard Deviation|Mean
837315|NCT01298362|Secondary|Mean Percentage Change in Lumbar Spine Bone Mineral Density From AI Commencement to Month 12 of Therapy.||Month 1-6 (depending on duration of chemotherapy) and month 13-18|Patients with LS BMD measurements both at AI commencement and at 12 months of AI therapy.||percentage of change||95% Confidence Interval|Mean
837316|NCT01298362|Secondary|Mean Percentage Change in Lumbar Spine Bone Mineral Density From Baseline (Before Chemotherapy Commencement) to Chemotherapy Completion||Baseline and month 1-6 (depending on duration of chemotherapy)|Patients with LS BMD measurements both at baseline (before chemotherapy commencement) and at chemotherapy completion||percentage of change||95% Confidence Interval|Mean
837317|NCT01298362|Secondary|Bone Fracture Rate||During the 12 months of AI Therapy|All patients with available 12 month follow-up during AI treatment||participants|||Number
837318|NCT01298362|Secondary|Percentage Change in Total Hip Bone Mineral Density Before AI Commencement to Month 12 of Therapy for Patients Who Are Treated With AIs as First Line Therapy||From AI commencement to month 12 of AI therapy|Patients with HIP BMD measurements both at AI commencement and at 12 months of AI therapy.||percentage of change||95% Confidence Interval|Mean
837319|NCT01298362|Secondary|Percentage Change in Lumbar Spine Bone Mineral Density Before AI Commencement to Month 12 of Therapy for Patients Who Are Treated With AIs as First Line Therapy||From AI commencement to month 12 of AI therapy|Patients with LS BMD measurements both at AI commencement and at 12 months of AI therapy.||percentage of change||95% Confidence Interval|Mean
837320|NCT01298362|Secondary|Percentage Change in Total Hip Bone Mineral Density From Baseline to Month 12 of AI Therapy.||Baseline and month 13-18 (1-6 months of chemotherapy + 12 months of AI therapy)|Patients with HIP BMD measurements both at baseline and at 12 months of AI therapy.||percentage of change||95% Confidence Interval|Mean
837335|NCT01298518|Secondary|Change From Baseline in Gastric Inhibitory Peptide (GIP) Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) at Day 28|Change from baseline in GIP area under the plasma concentration time curve was computed by Linear trapezoidal method.|Baseline (Day -1); 2 to 6 hours post-dose on Day 28|Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 GIP area under the curve (AUC) value. Here, 'n' is participants evaluable at specified time points for each group.||pg*hr/mL||Standard Deviation|Mean
837321|NCT01298362|Primary|Mean Percentage Change in Lumbar Spine Bone Mineral Density From Baseline (Before Chemotherapy Commencement) to Month 12 of AI Therapy|"BMD was evaluated at lumbar spine (LS) and hip (HIP) with measurements taken before CT, before AI therapy and at the end of the 12 month followup period while on AI treatment. Dual Energy X-Ray Absorptiometry (DEXA scan) was used with all measurements performed with the Explorer absorptiometer produced by Hologic, Bedford, MA, USA in the same referral site in Athens, apart from two centres in other cities which used however the same absorptiometer model with identical software.
The primary outcome variable was the mean percentage change in LS BMD between the pre CT treatment measurement and the post 12 months AI measurements in the CT cohort. The HT cohort was included as a control group."|Baseline and month 13-18 (1-6 months of chemotherapy + 12 months of AI therapy)|Patients with LS BMd measurements both at baseline and at 12 months of AI therapy.||percentage of change||95% Confidence Interval|Mean
837322|NCT01298492|Secondary|Serum Trough Concentrations of PF-00547659 Versus Time|Serum trough concentrations of PF-00547659 were analyzed using population Pharmacokinetic (PK) methodology.|Week 4,8,12,16,20,24,28,32,36,40,44,48,52,56,60,64,68,72,76,80,84,88,92,96|PK population included all enrolled participants who received at least 1 dose of investigational product and had data on at least 1 PK concentration.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
837323|NCT01298492|Secondary|Number of Participants With Positive Anti-Drug (PF-00547659) Antibodies|Positive Anti-Drug Antibodies result was defined as ADA titre value greater than or equal to (>=) 4.64 at at least one of the time points.|Baseline up to Week 96|The modified intent-to-treat (mITT) population included all enrolled participants who received at least 1 dose of investigational product.||Participants|||Count of Participants
837324|NCT01298492|Primary|Number of Participants With On-Treatment Adverse Events (AEs), AEs Led to Withdrawal, and Serious Adverse Events (SAEs)|AEs included adverse drug reactions, illnesses with onset during the study, exacerbation of previous illnesses, clinically significant changes in physical examination findings and abnormal objective test findings (ECG, laboratory). An SAE was defined as any AE at any dose that resulted in death; was life threatening (immediate risk of death); required in-subject hospitalization or prolongation of existing hospitalization; resulted in a persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); or resulted in congenital anomaly/birth defect.|From start of study treatment up to Week 72 (Treatment Period)|The modified intent-to-treat (mITT) population included all enrolled participants who received at least 1 dose of investigational product.||Participants|||Count of Participants
837325|NCT01298518|Secondary|Area Under the Concentration-Time Curve AUC (0-24) of PF-04620110|"Area under the plasma concentration-time curve from time 0 (pre-dose) to 24 hours.
AUC (0-24) was computed using the linear trapezoidal method."|24 hours post-morning dose on Day 28|Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 AUC(0-24) value.||ng*hr/mL||Standard Deviation|Geometric Mean
837326|NCT01298518|Secondary|Time to Cmax (Tmax) of PF-04620110||24 hours post-morning dose on Day 28|Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 Tmax value.||hr||Full Range|Median
837327|NCT01298518|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) of PF-04620110||24 hours post-morning dose on Day 28|Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 Cmin value.||ng/mL||Standard Deviation|Geometric Mean
837328|NCT01298518|Secondary|Maximum Observed Plasma Concentration (Cmax) of PF-04620110||24 hours post-morning dose on Day 28|Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 Cmax value.||ng/mL||Standard Deviation|Geometric Mean
837329|NCT01298518|Secondary|Change From Baseline in Post-Dinner Glucose Excursions Area Under the Concentration-Time Curve From Time 12 to 16 Hours (AUC 12-16) Post-dose at Day 28|Change from baseline in post-dinner glucose excursion under the plasma concentration time curve was computed by Linear trapezoidal method.|Baseline (Day -1); 12 to 16 hours post-dose on Day 28|Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 post-dinner glucose excursion area under the curve (AUC) value. Here, 'n' is participants evaluable at specified time points for each group.||mg*hr/dL||Standard Deviation|Mean
837330|NCT01298518|Secondary|Change From Baseline in Post-Lunch Glucose Excursions Area Under the Concentration-Time Curve From Time 6 to 10 Hours (AUC 6-10) Post-dose at Day 28|Change from baseline in post-lunch glucose excursion under the plasma concentration time curve was computed by Linear trapezoidal method.|Baseline (Day -1); 6 to 10 hours post-dose on Day 28|Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 post-lunch glucose excursion area under the curve (AUC) value. Here, 'n' is participants evaluable at specified time points for each group.||mg*hr/dL||Standard Deviation|Mean
837331|NCT01298518|Secondary|Change From Baseline in Fasting Net Triglycerides at Day 28||0 hour (pre-dose) on Day -1, Day 28|Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 fasting net triglycerides value. Here, 'n' is participants evaluable at specified time points for each group.||mg/dL||Standard Deviation|Mean
837332|NCT01298518|Secondary|Change From Baseline in Fasting Insulin at Day 28||0 hour (pre-dose) on Day -1, Day 28|Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 fasting insulin value. Here, 'n' is participants evaluable at specified time points for each group.||micro-IU/mL||Standard Deviation|Mean
837333|NCT01298518|Secondary|Change From Baseline in Fasting Glucose at Day 28||0 hour (pre-dose) on Day -1, Day 28|Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 fasting glucose value. Here, 'n' is participants evaluable at specified time points for each group.||mg/dL||Standard Deviation|Mean
837334|NCT01298518|Secondary|Change From Baseline in Peptide YY (PYY) Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) at Day 28|Change from baseline in PYY area under the plasma concentration time curve was computed by Linear trapezoidal method.|Baseline (Day -1); 2 to 6 hours post-dose on Day 28|Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PYY area under the curve (AUC) value. Here, 'n' is participants evaluable at specified time points for each group.||pg*hr/mL||Standard Deviation|Mean
837336|NCT01298518|Secondary|Change From Baseline in Total Amide Glucagon Like Peptide-1 (GLP-1) and Active Glucagon Like Peptide-1 (GLP-1) Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) at Day 28|Change from baseline in total amide GLP-1 and active GLP-1 area under the plasma concentration time curve was computed by Linear trapezoidal method.|Baseline (Day -1); 2 to 6 hours post-dose on Day 28|Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 total amide GLP-1 and active GLP-1 area under the curve (AUC) value. Here, 'n' is participants evaluable at specified time points for each group.||pmol*hr/L||Standard Deviation|Mean
837337|NCT01298518|Secondary|Change From Baseline in Post-Prandial Net Triglyceride Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28|Change from baseline in post-prandial area under the plasma net triglyceride concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.|Baseline (Day -1); 2 to 6 hours post-dose on Day 28|Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 post-MMTT net triglyceride area under the curve (AUC) value. Here, 'n' is participants evaluable at specified time points for each group.||mg*hr/dL||Standard Deviation|Mean
837338|NCT01298518|Secondary|Change From Baseline in Post-Prandial C-Peptide Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28|Change from baseline in post-prandial area under the plasma C-peptide concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.|Baseline (Day -1); 2 to 6 hours post-dose on Day 28|Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 post-MMTT C-peptide area under the curve (AUC) value. Here, 'n' is participants evaluable at specified time points for each group.||ng*hr/mL||Standard Deviation|Mean
837339|NCT01298518|Secondary|Change From Baseline in Post-Prandial Insulin Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28|Change from baseline in post-prandial plasma insulin AUC under the plasma insulin concentration versus time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.|Baseline (Day -1); 2 to 6 hours post-dose on Day 28|Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 post-MMTT insulin area under the curve (AUC) value. Here, 'n' is participants evaluable at specified time points for each group.||micro-IU*hr/mL||Standard Deviation|Mean
837340|NCT01298518|Secondary|Change From Baseline in 24-Hour Average Plasma Glucose (APG) Post-Dose at Day 28|APG= AUC (0-24)/24. AUC (0-24) was computed using Linear trapezoidal method.|Baseline (Day -1); 24 hours post-dose on Day 28|Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 APG value. Here, 'n' is participants evaluable at specified time points for each group.||mg/dL||Standard Deviation|Mean
837341|NCT01298518|Primary|Change From Baseline in Post-Prandial Glucose Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28|Change from baseline in post-prandial area under the plasma glucose concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.|Baseline (Day -1); 2 to 6 hours post-dose on Day 28|Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 post-MMTT glucose area under the curve (AUC) value. Here, 'n' is participants evaluable at specified time points for each group.||mg*hr/dL||Standard Deviation|Mean
837342|NCT01298531|Other Pre-specified|Change From Baseline in Chest Expansion at Weeks 12 and 16|Chest expansion, measured in cm, is defined as the difference in thoracic circumference during full expiration versus full inspiration, measured at the fourth intercostal space (nipple line). Chest expansion was measured for both maximum and minimum inhalation and the data presented below combined both the values.|Weeks 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.||cm||Standard Deviation|Mean
837343|NCT01298531|Other Pre-specified|Change From Baseline in Chest Expansion at Week 8|Chest expansion, measured in cm, is defined as the difference in thoracic circumference during full expiration versus full inspiration, measured at the fourth intercostal space (nipple line). Chest expansion was measured for both maximum and minimum inhalation and the data presented below combined both the values.|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.||cm||Standard Error|Least Squares Mean
837344|NCT01298531|Other Pre-specified|Change From Baseline in Chest Expansion at Week 4|Chest expansion, measured in cm, is defined as the difference in thoracic circumference during full expiration versus full inspiration, measured at the fourth intercostal space (nipple line). Chest expansion was measured for both maximum and minimum inhalation and the data presented below combined both the values.|Week 4|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.||cm||Standard Error|Least Squares Mean
837345|NCT01298531|Other Pre-specified|Change From Baseline in BASMI Components at Week 16|BASMI is an objective measure of spinal mobility. The BASMI score was composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10. For each BASMI component, the best of the two tries was taken which corresponded to the highest value for cervical rotation, intermalleolar distance, modified Schober’s test and lateral flexion and the smallest value for tragus to wall distance. For cervical rotation, lateral flexion and tragus to wall distance, a mean of the left and right measurements was taken.|Week 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.||Units on a scale||Standard Deviation|Mean
837346|NCT01298531|Other Pre-specified|Change From Baseline in BASMI Components at Week 12|BASMI is an objective measure of spinal mobility. The BASMI score was composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10. For each BASMI component, the best of the two tries was taken which corresponded to the highest value for cervical rotation, intermalleolar distance, modified Schober’s test and lateral flexion and the smallest value for tragus to wall distance. For cervical rotation, lateral flexion and tragus to wall distance, a mean of the left and right measurements was taken.|Week 12|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.||Units on a scale||Standard Deviation|Mean
837347|NCT01298531|Other Pre-specified|Change From Baseline in BASMI Components at Week 8|BASMI is an objective measure of spinal mobility. The BASMI score was composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10. For each BASMI component, the best of the two tries was taken which corresponded to the highest value for cervical rotation, intermalleolar distance, modified Schober’s test and lateral flexion and the smallest value for tragus to wall distance. For cervical rotation, lateral flexion and tragus to wall distance, a mean of the left and right measurements was taken.|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.||Units on a scale||Standard Deviation|Mean
837348|NCT01298531|Other Pre-specified|Change From Baseline in BASMI Components at Week 4|BASMI is an objective measure of spinal mobility. The BASMI score was composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10. For each BASMI component, the best of the two tries was taken which corresponded to the highest value for cervical rotation, intermalleolar distance, modified Schober’s test and lateral flexion and the smallest value for tragus to wall distance. For cervical rotation, lateral flexion and tragus to wall distance, a mean of the left and right measurements was taken.|Week 4|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.||Units on a scale||Standard Deviation|Mean
837349|NCT01298531|Other Pre-specified|Change From Baseline in BASMI at Weeks 12 and 16|BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.|Weeks 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.||Units on a scale||Standard Deviation|Mean
837350|NCT01298531|Other Pre-specified|Change From Baseline in BASMI at Week 8|BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Least Squares Mean
837351|NCT01298531|Other Pre-specified|Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 4|BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.|Week 4|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Least Squares Mean
837352|NCT01298531|Other Pre-specified|Number of Participants With PASS at Weeks 4, 12 and 16|PASS is defined as a symptom state that the participants consider acceptable. The PASS was collected weekly in the diary card, but at each visit this was collected in the CRF. Participants assessed their health in the previous 48 hours and whether it would be acceptable to remain like that in the next few months.|Weeks 4, 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.||Participants|||Number
837353|NCT01298531|Other Pre-specified|Number of Participants With Patient Acceptable Symptom State (PASS) at Week 8|PASS is defined as a symptom state that the participants consider acceptable. PASS was collected weekly in the diary card, but at each visit this was collected in the CRF. Participants assessed their health in the previous 48 hours and whether it would be acceptable to remain like that in the next few months.|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.||Participants|||Number
837372|NCT01298531|Other Pre-specified|Change From Baseline in Nocturnal Back Pain at Weeks 12 and 16|Participants assessed the nocturnal back pain they had in the previous 48 hours on a scale from 0 (no pain) to 10 (most severe pain).|Weeks 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.||Units on a scale||Standard Deviation|Mean
837354|NCT01298531|Other Pre-specified|Number of Participants With Minimum Clinically Important Deterioration (MCID) at Weeks 4, 8, 12 and 16|MCID was completed at Weeks 4, 8, 12 and 16 or Early Discontinuation and once weekly between visits. MCID was converted to binary scores as follows: 1 = ‘improved’/’very important’ and ‘improved’/’moderately important’ 2 = ‘improved’/’slightly important’, ‘improved’/’not at all important’, ‘no change’ and ‘worse-no pain. MCID was evaluated based on participant's opinion on the following three items for the question of how have they been during the last 48 hours compared to Screening visit: 'improved-less pain', 'no change', and 'worse-more pain'. Participants were further asked the importance of worsening i.e., very important, moderately important, slightly important and not at all important as MCID evaluation criteria.|Weeks 4, 8, 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.||Participants|||Number
837355|NCT01298531|Other Pre-specified|Number of Participants With MCII at Weeks 4, 12 and 16|MCII was completed at Weeks 4, 8, 12 and 16 or Early Discontinuation and once weekly between visits. MCII was converted to binary scores as follows: 1 = ‘improved’/’very important’ and ‘improved’/’moderately important’ 2 = ‘improved’/’slightly important’, ‘improved’/’not at all important’, ‘no change’ and ‘worse-no pain. MCII was determined based on participant's response on the following three items for the question of how have they been during the last 48 hours compared to when they started the study: improved or less pain, no change and worse-more pain. MCII was typically defined according to the patients perception of what was very important improvement, moderate important improvement, slightly important improvement or not at all improvement.|Weeks 4, 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.||Participants|||Number
837356|NCT01298531|Other Pre-specified|Number of Participants With Minimum Clinically Important Improvement (MCII) at Week 8|MCII was completed at visit weeks 4, 8, 12 and 16 or Early Discontinuation and once weekly between visits. MCII was converted to binary scores as follows: 1 = ‘improved’/’very important’ and ‘improved’/’moderately important’ 2 = ‘improved’/’slightly important’, ‘improved’/’not at all important’, ‘no change’ and ‘worse-no pain'. MCII was determined based on participant's response on the following three items for the question of how have they been during the last 48 hours compared to when they started the study: improved or less pain, no change and worse-more pain. MCII was typically defined according to the patients perception of what was very important improvement, moderate important improvement, slightly important improvement or not at all improvement.|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.||Participants|||Number
837357|NCT01298531|Other Pre-specified|Change From Baseline in MASES (Maastricht Ankylosing Spondylitis Entheses Score) Score at Weeks 4, 8, 12 and 16|Assessment of enthesitis was performed in the following 7 domains: 1) 1st costochondral joint left and right, 2) 7th costochondral joint left and right, 3) posterior superior iliac spine left and right, 4) anterior superior iliac spine left and right, 5) iliac crest left and right, 6) 5th lumbar spinous process and 7) proximal insertion of Achilles tendon left and right. Each domain was graded for the presence (1) and absence (0) of tenderness yielding total MASES ranging from 0 (no tenderness) to 13 (worst possible score; severe tenderness).|Weeks 4, 8, 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.||Units on a scale||Standard Deviation|Mean
837358|NCT01298531|Other Pre-specified|Change From Baseline in Tenderness Joint Counts at Weeks 4, 8, 12 and 16|Tender joint count was performed at each visit to assess the peripheral joint involvement according to ASAS recommendation.|Weeks 4, 8, 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.||Tender joints||Standard Deviation|Mean
837359|NCT01298531|Other Pre-specified|Change From Baseline in Swollen Joint Counts at Weeks 4, 8, 12 and 16|Swollen joint count was performed at each visit to assess the peripheral joint involvement according to ASAS recommendation.|Weeks 4, 8, 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.||Swollen joints||Standard Deviation|Mean
837360|NCT01298531|Other Pre-specified|Change From Baseline in Each BASFI Component at Week 16|BASFI is to assess the prticipant's level of ability to complete the activities on a scale from 0 (easy) to 10 (impossible). The total score was calculated as the average score of the 10 questions.|Week 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.||Units on a scale||Standard Deviation|Mean
837361|NCT01298531|Other Pre-specified|Change From Baseline in Each BASFI Component at Week 12|BASFI is to assess the prticipant's level of ability to complete the activities on a scale from 0 (easy) to 10 (impossible). The total score was calculated as the average score of the 10 questions.|Week 12|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.||Units on a scale||Standard Deviation|Mean
837501|NCT01299454|Secondary|Renal Clearance (CLr) of Brexipiprazole|"Urine samples were taken at pre-dose and during the following increments: 0 to 24, 24 to 48, 48 to 72, 72 to 96, 96 to 120, 120 to 144, and 144 to 168 hours postdose.
The value of CLr was calculated as Ae,u/AUCt."|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.||mL/h/kg||Standard Deviation|Mean
837362|NCT01298531|Other Pre-specified|Change From Baseline in Each BASFI Component at Week 8|BASFI is to assess the prticipant's level of ability to complete the activities on a scale from 0 (easy) to 10 (impossible). The total score was calculated as the average score of the 10 questions.|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.||Units on a scale||Standard Deviation|Mean
837363|NCT01298531|Other Pre-specified|Change From Baseline in Each BASFI Component at Week 4|BASFI is to assess the prticipant's level of ability to complete the activities on a scale from 0 (easy) to 10 (impossible). The total score was calculated as the average score of the 10 questions.|Week 4|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.||Units on a scale||Standard Deviation|Mean
837364|NCT01298531|Other Pre-specified|Change From Baseline in PGA at Weeks 12 and 16|Investigator assessed the overall disease activity using the scale of 0 (no disease activity) to 10 (severe disease activity).|Weeks 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.||Units on a scale||Standard Deviation|Mean
837365|NCT01298531|Other Pre-specified|Change From Baseline in PGA (Physician Global Assessment) at Week 8|Investigator assessed the overall disease activity using the scale of 0 (no disease activity) to 10 (severe disease activity).|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Least Squares Mean
837366|NCT01298531|Other Pre-specified|Change From Baseline in PGA (Physician Global Assessment) at Week 4|The investigator assessed the overall disease activity using the scale of 0 (no disease activity) to 10 (severe disease activity).|Week 4|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Least Squares Mean
837367|NCT01298531|Other Pre-specified|Change From Baseline in BASDAI Level of Morning Stiffness-related Scores at Weeks 12 and 16|Participants were requested to complete the BASDAI upon symptom return then every day for the first 15 days after first administration of test article and weekly thereafter. A numeric rating scale was used, for questions 1-5 (Fatigue, Spinal Pain, Joint pain or swelling, discomfort and morning stiffness severity respectively) it was on the scale from 0 (none) to 10 (very severe). For question 6 (morning stiffness duration) it was on the scale of 0 (0 or more hours) to 10 (2 hours). The analysis presented below is the change in morning stiffness severity.|Weeks 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.||Units on a scale||Standard Deviation|Mean
837368|NCT01298531|Secondary|Change From Baseline in BASDAI Level of Morning Stiffness-related Scores at Week 8|Participants were requested to complete the BASDAI upon symptom return then every day for the first 15 days after first administration of test article and weekly thereafter. A numeric rating scale was used, for questions 1-5 (Fatigue, Spinal Pain, Joint pain or swelling, discomfort and morning stiffness severity respectively) it was on the scale from 0 (none) to 10 (very severe). For question 6 (morning stiffness duration) it was on the scale of 0 (0 or more hours) to 10 (2 hours). The analysis presented below is the change in morning stiffness severity.|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Least Squares Mean
837369|NCT01298531|Other Pre-specified|Change From Baseline in BASDAI Level of Morning Stiffness-related Scores at Week 4|Participants were requested to complete the BASDAI upon symptom return then every day for the first 15 days after first administration of test article and weekly thereafter. A numeric rating scale was used, for questions 1-5 (Fatigue, Spinal Pain, Joint pain or swelling, discomfort and morning stiffness severity respectively) it was on the scale from 0 (none) to 10 (very severe). For question 6 (morning stiffness duration) it was on the scale of 0 (0 or more hours) to 10 (2 hours). The analysis presented below is the change in morning stiffness severity.|Week 4|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Least Squares Mean
837370|NCT01298531|Other Pre-specified|Change From Baseline in BASFI at Week 8|Participants assessed their level of ability to complete activities on a scale from 0 (easy) to 10 (impossible). These scales were collected at each visit in the CRF. The total score was calculated as the average score of the 10 questions.|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Least Squares Mean
837371|NCT01298531|Other Pre-specified|Change From Baseline in BASFI (Bath Ankylosing Spondylitis Functional Index ) at Week 4|Participants assessed their level of ability to complete activities on a scale from 0 (easy) to 10 (impossible). These scales were collected at each visit in the CRF. The total score was calculated as the average score of the 10 questions.|Week 4|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Least Squares Mean
837373|NCT01298531|Other Pre-specified|Change From Baseline in Nocturnal Back Pain at Week 8|Participants assessed the nocturnal back pain they had in the previous 48 hours on a scale from 0 (no pain) to 10 (most severe pain).|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Least Squares Mean
837374|NCT01298531|Other Pre-specified|Change From Baseline in Nocturnal Back Pain at Week 4|Participants assessed the nocturnal back pain they had in the previous 48 hours on a scale from 0 (no pain) to 10 (most severe pain).|Week 4|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Least Squares Mean
837375|NCT01298531|Other Pre-specified|Change From Baseline in Total Back Pain at Weeks 4, 8, 12 and 16|Participants assessed the total back pain they had in the previous 48 hours on a scale from 0 (no pain) to 10 (most severe pain).|Weeks 4, 8, 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.||Units on a scale||Standard Deviation|Mean
837376|NCT01298531|Other Pre-specified|Change From Baseline in Total Back Pain at Week 8|Participants assessed the total back pain they had in the previous 48 hours on a scale from 0 (no pain) to 10 (most severe pain).|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Least Squares Mean
837377|NCT01298531|Other Pre-specified|Change From Baseline in Total Back Pain at Week 4|Participants assessed the total back pain they had in the previous 48 hours on a scale from 0 (no pain) to 10 (most severe pain).|Week 4|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Least Squares Mean
837378|NCT01298531|Other Pre-specified|Change From Baseline in BAS-G Score at Weeks 12 and 16.|BAS-G was used to indicate the effect of disease has had on participant's well-being over the last 48 hours in a 0 (none) to 10 (very severe) point scale. Participants completed the BAS-G on a diary card following their Screening visit if they had a flare which required them to restart their NSAID. Participants were requested to complete the BAS-G upon symptom return (after stoppage of NSAIDs during screening phase) and weekly thereafter.|Weeks 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.||Units on a scale||Standard Deviation|Mean
837379|NCT01298531|Other Pre-specified|Change From Baseline in BAS-G Score at Week 8|BAS-G was used to indicate the effect of disease has had on participant's well-being over the last 48 hours in a 0 (none) to 10 (very severe) point scale. Participants completed the BAS-G on a diary card following their Screening visit if they had a flare which required them to restart their NSAID. Participants were requested to complete the BAS-G upon symptom return (after stoppage of NSAIDs during screening phase) and weekly thereafter.|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Least Squares Mean
837380|NCT01298531|Other Pre-specified|Change From Baseline in BAS-G (Bath Ankylosing Spondylitis-Global) Score at Week 4|BAS-G was used to indicate the effect of disease has had on participant's well-being over the last 48 hours in a 0 (none) to 10 (very severe) point scale. Participants completed the BAS-G on a diary card following their Screening visit if they had a flare which required them to restart their NSAID. Participants were requested to complete the BAS-G upon symptom return (after stoppage of NSAIDs during screening phase) and weekly thereafter.|Week 4|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Least Squares Mean
837381|NCT01298531|Secondary|Change in NSAID ASAS Score From Week 8 to Week 16 (Placebo Only)|"Diary data from the 7 days prior to respective visit were used to evaluate the endpoint, where the score was only calculated if at least 5 of the 7 days data were available. Score was calculated from NSAID usage completed on diary cards considering NSAID type, total daily dose and number of days consumed. The Daily diclofenac-equivalent dose score was derived by converting each daily dose of NSAID to a percentage dose equivalent of 150 mg diclofenac; e.g. 1000 mg naproxen is equivalent to 150 mg diclofenac. For each NSAID, the percentage diclofenac-equivalent score is then multiplied by daily dose frequency and proportion of the period where dose was taken.
Ie Score=M x F x n/N (M: Percentage dose equivalent to diclofenac; F=Daily Dose Frequency; n=number of days with NSAID; N=number of days in period). The NSAID ASAS score is the sum of all such scores for all NSAIDs taken during the period. The minimum value is 0 and a higher NSAID-ASAS value indicates greater NSAIDs consumption."|Week 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases with no imputation.||Scores on a scale||Standard Error|Least Squares Mean
837419|NCT01298661|Secondary|"Second Six Minute Step Test Peripheral Oxygen Saturation"|"This test will be conducted by the Rater 1, the patient will step up and down one 20cm step during six minute. It will be evaluated by a pulse oxymeter ."|First day or second day of the protocol (random) ,30 minutes after the first 6MST|2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.||% of hemoglobin||Standard Deviation|Mean
837382|NCT01298531|Secondary|Change in NSAID ASAS Score From Baseline to Week 16 (ETN Arm Only)|"Diary data from the 7 days prior to respective visit were used to evaluate the endpoint, where the score was only calculated if at least 5 of the 7 days data were available. Score was calculated from NSAID usage completed on diary cards considering NSAID type, total daily dose and number of days consumed. The Daily diclofenac-equivalent dose score was derived by converting each daily dose of NSAID to a percentage dose equivalent of 150 mg diclofenac; e.g. 1000 mg naproxen is equivalent to 150 mg diclofenac. For each NSAID, the percentage diclofenac-equivalent score is then multiplied by daily dose frequency and proportion of the period where dose was taken.
Ie Score=M x F x n/N (M: Percentage dose equivalent to diclofenac; F=Daily Dose Frequency; n=number of days with NSAID; N=number of days in period). The NSAID ASAS score is the sum of all such scores for all NSAIDs taken during the period. The minimum value is 0 and a higher NSAID-ASAS value indicates greater NSAIDs consumption."|Week 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases with no imputation.||Scores on a scale||Standard Error|Least Squares Mean
837383|NCT01298531|Secondary|Change From Baseline in ASDAS ESR Score at Weeks 12 and 16.|"The ASDAS-ESR was derived from back pain, duration of morning stiffness, patient global score and peripheral pain/swelling. The scores were categorized as follows : inactive disease (< 1.3), moderate (1.3 – < 2.1), high (2.1 – 3.5) and very high disease activity ( > 3.5). ASDAS ESR is calculated as follows:
ASDAS ESR=0.08*Total Back Pain+0.07*Duration of Morning Stiffness+0.11*Patient Global+0.09*Peripheral Pain/Swelling+0.29*√(ESR)."|Weeks 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.||Units on a scale||Standard Deviation|Mean
837384|NCT01298531|Secondary|Change From Baseline in ASDAS ESR Score at Week 8.|"The ASDAS-ESR was derived from back pain, duration of morning stiffness, patient global score and peripheral pain/swelling. The scores were categorized as follows : inactive disease (< 1.3), moderate (1.3 – < 2.1), high (2.1 – 3.5) and very high disease activity ( > 3.5). ASDAS ESR is calculated as follows:
ASDAS ESR=0.08*Total Back Pain+0.07*Duration of Morning Stiffness+0.11*Patient Global+0.09*Peripheral Pain/Swelling+0.29*√(ESR)."|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Least Squares Mean
837385|NCT01298531|Secondary|Change From Baseline in ASDAS ESR (Ankylosing Spondylitis Disease Activity Score-Erythrocyte Sedimentation Rate) Score at Week 4.|"The ASDAS-ESR was derived from back pain, duration of morning stiffness, patient global score and peripheral pain/swelling. The scores were categorized as follows : inactive disease (< 1.3), moderate (1.3 – < 2.1), high (2.1 – 3.5) and very high disease activity ( > 3.5). ASDAS ESR is calculated as follows:
ASDAS ESR=0.08*Total Back Pain+0.07*Duration of Morning Stiffness+0.11*Patient Global+0.09*Peripheral Pain/Swelling+0.29*√(ESR)."|Week 4|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Least Squares Mean
837386|NCT01298531|Secondary|Change From Baseline in ASDAS CRP Score at Weeks 12 and 16.|"The ASDAS-CRP was derived from back pain, duration of morning stiffness, patient global score and peripheral pain/swelling. The scores were categorized as follows : inactive disease(< 1.3), moderate (1.3 – < 2.1), high (2.1 – 3.5) and very high disease activity ( > 3.5). ASDAS CRP is calculated as follows:
ASDAS CRP=0.12*Total Back Pain+0.06*Duration of Morning Stiffness+0.11*Patient Global+0.07*Peripheral Pain/Swelling+0.58*ln(CRP+1)."|Weeks 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.||Units on scale||Standard Deviation|Mean
837387|NCT01298531|Secondary|Change From Baseline in ASDAS CRP Score at Week 8.|"The ASDAS-CRP was derived from back pain, duration of morning stiffness, patient global score and peripheral pain/swelling. The scores were categorized as follows : inactive disease(< 1.3), moderate (1.3 – < 2.1), high (2.1 – 3.5) and very high disease activity ( > 3.5). ASDAS CRP is calculated as follows:
ASDAS CRP=0.12*Total Back Pain+0.06*Duration of Morning Stiffness+0.11*Patient Global+0.07*Peripheral Pain/Swelling+0.58*ln(CRP+1)."|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Least Squares Mean
837388|NCT01298531|Secondary|Change From Baseline in ASDAS CRP (Ankylosing Spondylitis Disease Activity Score-C Reactive Protein) Score at Week 4.|"The ASDAS-CRP was derived from back pain, duration of morning stiffness, patient global score and peripheral pain/swelling. The scores were categorized as follows : inactive disease(< 1.3), moderate (1.3 – < 2.1), high (2.1 – 3.5) and very high disease activity ( > 3.5). ASDAS CRP is calculated as follows:
ASDAS CRP=0.12*Total Back Pain+0.06*Duration of Morning Stiffness+0.11*Patient Global+0.07*Peripheral Pain/Swelling+0.58*ln(CRP+1)."|Week 4|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Least Squares Mean
837389|NCT01298531|Secondary|Number of Participants Achieving ASAS 70 at Week 8|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 70 = 70% improvement from baseline and an absolute change ≥ 20 units on a 0-100 scale (0=no disease activity, 100=high disease activity)|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.||Participants|||Number
837390|NCT01298531|Secondary|Number of Participants Achieving ASAS 70 at Weeks 4, 12 and 16.|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 70 = 70% improvement from baseline and an absolute change ≥ 20 units on a 0-100 scale (0=no disease activity, 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|Weeks 4, 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.||Participants|||Number
837391|NCT01298531|Secondary|Number of Participants Achieving ASAS 40 at Week 8|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40% improvement from baseline and an absolute change ≥ 20 units on a 0-100 scale (0=no disease activity, 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.||Participants|||Number
837392|NCT01298531|Secondary|Number of Participants Achieving ASAS 40 at Weeks 4, 12 and 16.|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40% improvement from baseline and an absolute change ≥ 20 units on a 0-100 scale (0=no disease activity, 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|Weeks 4, 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.||Participants|||Number
837393|NCT01298531|Secondary|Number of Participants Achieving ASAS 20 at Week 8|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement from baseline and an absolute change ≥ 10 units on a 0-100 scale (0=no disease activity; 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.||Participants|||Number
837394|NCT01298531|Secondary|Number of Participants Achieving ASAS 20 (Assessment of the Spondylo Arthritis International Society 20) at Weeks 4, 12 and 16|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement from baseline and an absolute change ≥ 10 units on a 0-100 scale (0=no disease activity; 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|Weeks 4, 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.||Participants|||Number
837395|NCT01298531|Secondary|Number of Participants Achieved BASDAI 50 at Weeks 4, 12 and 16.|Response was defined as a 50% improvement of the baseline BASDAI after 4, 12 and 16 Weeks.|Weeks 4, 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.||Participants|||Number
837396|NCT01298531|Secondary|Number of Participants Achieved BASDAI 50 at Week 8.|Response was defined as a 50% improvement of the baseline BASDAI after 8 Weeks.|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.||Participants|||Number
837397|NCT01298531|Secondary|Change From Baseline in Mini BASDAI at Week 8 (AUC).|A numeric rating scale was used, for questions 1-5 (Fatigue, Spinal Pain, Joint pain or Swelling, Discomfort and Morning stiffness severity respectively) on a scale from 0 (none) to 10 (very severe). Question 6 (morning stiffness duration) was recorded on a scale of 0 (0 or more hours) to 10 (2 hours). To give the five major AS symptoms equal weighting, the average of the two scores relating to morning stiffness was taken. This averaged morning stiffness score was then summed with the remaining 4 questions, resulting in a composite score on a scale of 0-50, which was then divided by 5 to give the final BASDAI score on a scale of 0-10.|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. The efficacy analysis was based on the ITT population. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis.||Unit on a scale * days||Standard Error|Least Squares Mean
837398|NCT01298531|Secondary|Number of Participants Using NSAIDs at Week 8.|Participants who received NSAIDs at Week 8 were reported.|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was with the observed cases.||Participants|||Number
837399|NCT01298531|Secondary|Change From Baseline in BASDAI Score at Weeks 12 and 16.|A numeric rating scale was used, for questions 1-5 (Fatigue, Spinal Pain, Joint pain or Swelling, Discomfort and Morning stiffness severity respectively) on a scale from 0 (none) to 10 (very severe). Question 6 (morning stiffness duration) was recorded on a scale of 0 (0 or more hours) to 10 (2 hours). To give the five major AS symptoms equal weighting, the average of the two scores relating to morning stiffness was taken. This averaged morning stiffness score was then summed with the remaining 4 questions, resulting in a composite score on a scale of 0-50, which was then divided by 5 to give the final BASDAI score on a scale of 0-10.|Week 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was with the observed cases.||Units on a scale||Standard Deviation|Mean
837400|NCT01298531|Secondary|Change From Baseline in BASDAI at Week 8|A numeric rating scale was used, for questions 1-5 (Fatigue, Spinal Pain, Joint pain or Swelling, Discomfort and Morning stiffness severity respectively) on a scale from 0 (none) to 10 (very severe). Question 6 (morning stiffness duration) was recorded on a scale of 0 (0 or more hours) to 10 (2 hours). To give the five major AS symptoms equal weighting, the average of the two scores relating to morning stiffness was taken. This averaged morning stiffness score was then summed with the remaining 4 questions, resulting in a composite score on a scale of 0-50, which was then divided by 5 to give the final BASDAI score on a scale of 0-10.|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Least Squares Mean
837401|NCT01298531|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 4.|A numeric rating scale was used, for questions 1-5 (Fatigue, Spinal Pain, Joint pain or Swelling, Discomfort and Morning stiffness severity respectively) on a scale from 0 (none) to 10 (very severe). Question 6 (morning stiffness duration) was recorded on a scale of 0 (0 or more hours) to 10 (2 hours). To give the five major Ankylosing Spondylitis (AS) symptoms equal weighting, the average of the two scores relating to morning stiffness was taken. This averaged morning stiffness score was then summed with the remaining 4 questions, resulting in a composite score on a scale of 0-50, which was then divided by 5 to give the final BASDAI score on a scale of 0-10.|Week 4|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Least Squares Mean
837402|NCT01298531|Secondary|Total NSAID ASAS [Area Under Curve (AUC)] Score From Baseline to Week 8.|The total NSAID score for the first 8 weeks of randomized treatment was calculated as an AUC using the linear trapezoidal rule. LOCF will only be applied where the subject is still in the study and the NSAID score is missing.|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.||Unit on a scale * days||Standard Error|Least Squares Mean
837403|NCT01298531|Primary|Change From Baseline in Non Steroidal Anti Inflammatory Drug (NSAID) Assessment of the SpondyloArthritis International Society (ASAS) Score at Week 8.|"Diary data from the 7 days prior to respective visit were used to evaluate the endpoint, where the score was only calculated if at least 5 of the 7 days data were available. Score was calculated from NSAID usage completed on diary cards considering NSAID type, total daily dose and number of days consumed. The Daily diclofenac-equivalent dose score was derived by converting each daily dose of NSAID to a percentage dose equivalent of 150 mg diclofenac; e.g. 1000 mg naproxen is equivalent to 150 mg diclofenac. For each NSAID, the percentage diclofenac-equivalent score is then multiplied by daily dose frequency and proportion of the period where dose was taken.
Ie Score=M x F x n/N (M: Percentage dose equivalent to diclofenac; F=Daily Dose Frequency; n=number of days with NSAID; N=number of days in period). The NSAID ASAS score is the sum of all such scores for all NSAIDs taken during the period. The minimum value is 0 and a higher NSAID-ASAS value indicates greater NSAIDs consumption."|Week 8|The Intent To Treat (ITT) population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through last observation carried forward (LOCF).||Scores on a scale||Standard Error|Least Squares Mean
837404|NCT01298544|Other Pre-specified|Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL, 36 Months After the Toddler Dose|Percentage of participants achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F). Exact 2-sided CI based on the observed proportion of participants.|Day 1 (36 months after toddler dose)|Evaluable Immunogenicity population||Percentage of participants||95% Confidence Interval|Number
837405|NCT01298544|Primary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 36 Months After the Toddler Dose|Antibody geometric mean concentration (GMC) as measured by mcg/mL for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F). GMC (7vPnC, 7vPnC/DTaP, and DTap) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.|Day 1 (36 months after toddler dose)|Evaluable Immunogenicity population: eligible participants who had blood drawn within required time frame, had at least 1 valid and determinate assay result for the proposed analysis, received no prohibited vaccines, and had no major protocol violations.||microgram per milliliter (mcg/mL)||95% Confidence Interval|Geometric Mean
837406|NCT01298648|Secondary|Remission Rate at Week 4, Week 8, and Week 24|The remission rate for each evaluation timepoint (Weeks 4, 8, and 24) was calculated as the number of participants that had CDAI < 150 divided by the number of participants at Baseline that had CDAI scores ≥ 150.|Baseline, Week 4, Week 8, and Week 24|Participants with available data at each time point.||percentage of participants|||Number
837407|NCT01298648|Primary|Crohn's Disease Activity Index (CDAI) at Baseline and Week 24|The CDAI is used to evaluate the activity of Crohn's disease. The CDAI is calculated on the basis of a one-week evaluation of 8 items and ranges from 0 to about 600. The 8 items are frequency of liquid or very soft stool, abdominal pain, complications of Crohn's disease (e.g., uveitis, arthritis, fistula, and abscess), abdominal mass, hematocrit, body weight, use of antidiarrheals, and general condition. Low scores indicate low activity of Crohn's disease. In general, CDAI scores below 150 represent remission and scores over 450 represent very severe Crohn's disease.|Baseline, Week 24|Participants with available data at each time point.||scores on a scale||Standard Deviation|Mean
837420|NCT01298661|Secondary|"First Six Minute Step Test Peripheral Oxygen Saturation"|"This test will be conducted by the Rater 1, the patient will step up and down one 20cm step during six minute. It will be evaluated by a pulse oxymeter."|First day or second day of the protocol (random)|2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.||% of hemoglobin||Standard Deviation|Mean
837408|NCT01298648|Primary|Crohn's Disease Activity Index (CDAI) at Baseline and Week 8|The CDAI is used to evaluate the activity of Crohn's disease. The CDAI is calculated on the basis of a one-week evaluation of 8 items and ranges from 0 to about 600. The 8 items are frequency of liquid or very soft stool, abdominal pain, complications of Crohn's disease (e.g., uveitis, arthritis, fistula, and abscess), abdominal mass, hematocrit, body weight, use of antidiarrheals, and general condition. Low scores indicate low activity of Crohn's disease. In general, CDAI scores below 150 represent remission and scores over 450 represent very severe Crohn's disease.|Baseline, Week 8|Participants with available data at each time point.||scores on a scale||Standard Deviation|Mean
837409|NCT01298648|Secondary|Improvement Rating by Investigator at Week 24|Overall response rating, according to investigator’s subjective clinical opinion. The level of improvement (markedly improved, improved, not improved, or not assessable) was categorized by comparing clinical condition at week 24 or at discontinuation with baseline condition.|Week 24|||percentage of participants|||Number
837410|NCT01298648|Primary|Crohn's Disease Activity Index (CDAI) at Baseline and Week 4|The CDAI is used to evaluate the activity of Crohn's disease. The CDAI is calculated on the basis of a one-week evaluation of 8 items and ranges from 0 to about 600. The 8 items are frequency of liquid or very soft stool, abdominal pain, complications of Crohn's disease (e.g., uveitis, arthritis, fistula, and abscess), abdominal mass, hematocrit, body weight, use of antidiarrheals, and general condition. Low scores indicate low activity of Crohn's disease. In general, CDAI scores below 150 represent remission and scores over 450 represent very severe Crohn's disease.|Baseline, Week 4|Participants with available data at each time point.||scores on a scale||Standard Deviation|Mean
837411|NCT01298648|Primary|Number of Participants With Adverse Events (AEs)|An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. An Adverse Drug Reaction (ADR) is any noxious and undesired reaction related to an experimental drug or experiment. A serious AE (SAE) is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome. AEs were rated for severity as either Mild: transient and easily tolerated; Moderate: causes discomfort and interrupts usual activities; or Severe: causes considerable interference with usual activities, may be incapacitating or life-threatening. AEs related to adalimumab were assessed as being either probably or possibly related by the investigator. An Unexpected ADR is an ADR for which the nature or gravity is not consistent with the applicable product information.|24 weeks|Safety analysis set: Excluding 21 patients who were transferred to other institutions during the surveillance period and 2 patients who made no visit after the first administration, 1693 patients were included in the safety analysis set.||participants|||Number
837412|NCT01298661|Secondary|"Third Six Minute Step Test Heart Rate"|"This test will be conducted by the Rater 2, the patient will step up and down a 20cm step during six minute. It will be evaluated by a cardio monitor."|On the third day of evaluation, seven days after the first day of evaluation. Since it was performed in the same day of the third 6MWT, the choice of the first test was random, and there was a 30 minute interval between them.|2 COPD patients and 2 healthy young individuals were excluded from the study since they did not appeared in the second day of evaluation. 3 COPD patient Analysis Population Description: s and 5 elderly subjects didn't show on the third day of evaluation, then, they were just excluded in the analysis of the variables collected in this day.||bpm||Standard Deviation|Mean
837413|NCT01298661|Secondary|"Second Six Minute Step Test Heart Rate"|"This test will be conducted by the Rater 1, the patient will step up and down a 20cm step during six minute. It will be evaluated by a cardio monitor."|First day or second day of the protocol (random), 30 minutes after the first 6MST|2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.||bpm||Standard Deviation|Mean
837414|NCT01298661|Secondary|"First Six Minute Step Test Heart Rate"|"This test will be conducted by the Rater 1, the patient will step up and down a 20cm step during six minute. It will be evaluated by a cardio monitor."|First day or second day of the protocol (random)|2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.||bpm||Standard Deviation|Mean
837415|NCT01298661|Secondary|"Third Six Minute Walk Test Heart Rate"|"This test will be conducted by the Rater 2, the subject will walk as far as it can in a 30m corridor during 6 minutes. It will be evaluated by a cardio monitor."|On the third day of evaluation, seven days after the first day of evaluation. Since it was performed in the same day of the third 6MST, the choice of the first test was random, and there was a 30 minute interval between them.|2 COPD patients and 2 healthy young individuals were excluded from the study since they did not appeared in the second day of evaluation. 3 COPD patient Analysis Population Description: s and 5 elderly subjects didn't show on the third day of evaluation, then, they were just excluded in the analysis of the variables collected in this day.||bpm||Standard Deviation|Mean
837416|NCT01298661|Secondary|"Second Six Minute Walk Test Heart Rate"|"This test will be conducted by the Rater 1, the subject will walk as far as it can in a 30m corridor during 6 minutes. It will be evaluated by a cardio monitor at rest and every two minutes of the test."|First day or second day of the protocol (random), 30 minutes after the first 6MWT|2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.||bpm||Standard Deviation|Mean
837417|NCT01298661|Secondary|"First Six Minute Walk Test Heart Rate"|"This test will be conducted by the Rater 1, the subject will walk as far as it can in a 30m corridor during 6 minutes. It will be evaluated by a cardio monitor."|First day or second day of the protocol (random)|2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.||bpm||Standard Deviation|Mean
837418|NCT01298661|Secondary|"Third Six Minute Step Test Peripheral Oxygen Saturation"|"This test will be conducted by the Rater 2, the patient will step up and down one 20cm step during six minute. It will be evaluated by a pulse oxymeter."|On the third day of evaluation, seven days after the first day of evaluation. Since it was performed in the same day of the third 6MWT, the choice of the first test was random, and there was a 30 minute interval between them.|2 COPD patients and 2 healthy young individuals were excluded from the study since they did not appeared in the second day of evaluation. 3 COPD patient Analysis Population Description: s and 5 elderly subjects didn't show on the third day of evaluation, then, they were just excluded in the analysis of the variables collected in this day.||% of hemoglobin||Standard Deviation|Mean
837421|NCT01298661|Secondary|"Third Six Minute Walk Test Peripheral Oxygen Saturation"|"This test will be conducted by the Rater 2, the subject will walk as far as it can in a 30m corridor during 6 minutes. It will be evaluated by a pulse oxymeter."|On the third day of evaluation, seven days after the first day of evaluation. Since it was performed in the same day of the third 6MST, the choice of the first test was random, and there was a 30 minute interval between them.|2 COPD patients and 2 healthy young individuals were excluded from the study since they did not appeared in the second day of evaluation. 3 COPD patient Analysis Population Description: s and 5 elderly subjects didn't show on the third day of evaluation, then, they were just excluded in the analysis of the variables collected in this day.||% of hemoglobin||Standard Deviation|Mean
837422|NCT01298661|Secondary|"Second Six Minute Walk Test Peripheral Oxygen Saturation"|"This test will be conducted by the Rater 1, the subject will walk as far as it can in a 30m corridor during 6 minutes. It will be evaluated by a pulse oxymeter."|,First day or second day of the protocol (random) 30 minutes after the first 6MWT|2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.||% of hemoglobin||Standard Deviation|Mean
837423|NCT01298661|Secondary|"First Six Minute Walk Test Peripheral Oxygen Saturation"|"This test will be conducted by the Rater 1, the subject will walk as far as it can in a 30m corridor during 6 minutes. It will be evaluated by a pulse oxymeter."|First day or second day of the protocol (random)|2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.||% of hemoglobin||Standard Deviation|Mean
837424|NCT01298661|Secondary|"Third Six Minute Step Test Exertion Perception"|"This test will be conducted by the Rater 2, the patient will step up down one 20cm step during six minute. The Exertion Perception will be evaluated using BORG scale. This scale is a self-reported scale, which range from 0 to 10, where 0 means none exertion perception and 10 means very intense exertion perception (the highest the patient has ever felt). Lower values means that the patient feel less discomfort."|On the third day of evaluation, seven days after the first day of evaluation. Since it was performed in the same day of the third 6MWT, the choice of the first test was random, and there was a 30 minute interval between them.|2 COPD patients and 2 healthy young individuals were excluded from the study since they did not appeared in the second day of evaluation. 3 COPD patient Analysis Population Description: s and 5 elderly subjects didn't show on the third day of evaluation, then, they were just excluded in the analysis of the variables collected in this day.||units on a scale||Full Range|Median
837425|NCT01298661|Secondary|"Second Six Minute Step Test Exertion Perception"|"This test will be conducted by the Rater 1, the patient will step up and down one 20cm step during six minute.The Exertion Perception will be evaluated using BORG scale. This scale is a self-reported scale, which range from 0 to 10, where 0 means none exertion perception and 10 means very intense exertion perception (the highest the patient has ever felt). Lower values means that the patient feel less discomfort."|First day or second day of the protocol (random), 30 minutes after the first 6MST|2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.||units on a scale||Full Range|Median
837426|NCT01298661|Secondary|"First Six Minute Step Test Exertion Perception"|"This test will be conducted by the Rater 1, the patient will step up and down one 20cm step during six minute. The Exertion Perception will be evaluated using BORG scale. This scale is a self-reported scale, which range from 0 to 10, where 0 means none exertion perception and 10 means very intense exertion perception (the highest the patient has ever felt). Lower values means that the patient feel less discomfort."|First day or second day of the protocol (random)|2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.||units on a scale||Full Range|Median
837427|NCT01298661|Secondary|"Third Six Minute Walk Test Exertion Perception"|"This test will be conducted by the Rater 2, the subject will walk as far as it can in a 30m corridor during 6 minutes. The Exertion Perception will be evaluated using BORG scale. This scale is a self-reported scale, which range from 0 to 10, where 0 means none exertion perception and 10 means very intense exertion perception (the highest the patient has ever felt). Lower values means that the patient feel less discomfort."|On the third day of evaluation, seven days after the first day of evaluation. Since it was performed in the same day of the third 6MST, the choice of the first test was random, and there was a 30 minute interval between them.|2 COPD patients and 2 healthy young individuals were excluded from the study since they did not appeared in the second day of evaluation. 3 COPD patient Analysis Population Description: s and 5 elderly subjects didn't show on the third day of evaluation, then, they were just excluded in the analysis of the variables collected in this day.||units on a scale||Full Range|Median
837428|NCT01298661|Secondary|"Second Six Minute Walk Test Exertion Perception"|"This test will be conducted by the Rater 1, the subject will walk as far as it can in a 30m corridor during 6 minutes. The Exertion Perception will be evaluated using BORG scale. This scale is a self-reported scale, which range from 0 to 10, where 0 means none exertion perception and 10 means very intense exertion perception (the highest the patient has ever felt). Lower values means that the patient feel less discomfort."|First day or second day of the protocol (random), 30 minutes after the first 6MWT|2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.||units on a scale||Full Range|Median
837429|NCT01298661|Secondary|"First Six Minute Walk Test Exertion Perception"|"This test was conducted by the Rater 1, the subject walked as far as it could in a 30m corridor during 6 minutes. The Exertion Perception will be evaluated using BORG scale. This scale is a self-reported scale, which range from 0 to 10, where 0 means none exertion perception and 10 means very intense exertion perception (the highest the patient has ever felt). Lower values means that the patient feel less discomfort."|First day or second day of the protocol (random)|2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.||units on a scale||Full Range|Median
837447|NCT01299025|Secondary|Change in Score on the Dynamic Gait Index From Day 1 to Day 42|The Dynamic Gait index consists of 8 items. Performance on each item is rated from 0 (severe impairment) to 3 (nomal performance). Minimum total score is 0 and maximum 24. Higher scores indicate better walking and balance performance.|Measured at day 1 (before training) and day 42 (after training)|||Scores on a scale||Standard Deviation|Mean
837448|NCT01299025|Primary|Change in Timed Up and Go Test From Day 1 to Day 42|Change in seconds on the Timed Up and Go test (TUG). In the TUG test time is taken from rising from a chair, walking 3 meters, turning,walking back and sitting down.|Measured at day 1 (before the training period) and at day 42 (after the training period)|||seconds||Standard Deviation|Mean
837430|NCT01298661|Secondary|"Body-Mass Index, Airflow Obstruction, Dyspnea, Exercise Capacity Index (BODE Index)"|"It was evaluated only in the COPD patients. BODE index is a prognostic index used in COPD patients, it is a 0-10 scale, where lower values means better prognostic. It is composed by other commonly used evaluations tools in COPD, Forced Expiratory Volume in the First second (from spirometry); classification in the scale ranging from 0-3, Body-mass index, classification in the scale ranging from 0-1; Six-minute walk test distance, classification in the scale ranging from 0-3 and referred dyspnea, classification in the scale ranging from 0-3.
It was only used the total score (0-10)"|Second day|2 COPD were excluded since they did not appeared in the second day of evaluation. The other two populations were not verified, since the measure is specific for COPD patients||units on a scale||Inter-Quartile Range|Median
837431|NCT01298661|Secondary|"Third Six Minute Walk Test Distance"|"This test will be conducted by the Rater 2, the subject will walk as far as it can in a 30m corridor during 6 minutes. The performance will be the distance (meters)that it walk."|On the third day of evaluation, seven days after the first day of evaluation. Since it was performed in the same day of the third 6MST, the choice of the first test was random, and there was a 30 minute interval between them.|2 COPD patients and 2 healthy young individuals were excluded from the study since they did not appeared in the second day of evaluation. 3 COPD patient Analysis Population Description: s and 5 elderly subjects didn't show on the third day of evaluation, then, they were just excluded in the analysis of the variables collected in this day.||meter||Standard Deviation|Mean
837432|NCT01298661|Secondary|"Second Six Minute Walk Test Distance"|"This test will be conducted by the Rater 1, the subject will walk as far as it can in a 30m corridor during 6 minutes. The performance will be the distance (meters)that it walk."|On the first or second day of evaluation (random), 30 minutes after the first 6MWT.|2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.||meter||Standard Deviation|Mean
837433|NCT01298661|Secondary|"First Six Minute Walk Test Distance"|"This test will be conducted by the Rater 1, the subject will walk as far as it can in a 30m corridor during 6 minutes. The performance will be the distance (meters)that it walk."|First day or second day of the protocol (random)|2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.||meter||Standard Deviation|Mean
837434|NCT01298661|Primary|"Third Six Minute Step Test Performance"|"This test will be conducted by the Rater 2, the patient will step up and down a 20cm step during six minutes. The performance will be evaluated by the number of the climbs."|On the third day of evaluation, seven days after the first day of evaluation. Since it was performed in the same day of the third 6MWT, the choice of the first test was random, and there was a 30 minute interval between them.|2 COPD patients and 2 healthy young individuals were excluded from the study since they did not appeared in the second day of evaluation. 3 COPD patient Analysis Population Description: s and 5 elderly subjects didn't show on the third day of evaluation, then, they were just excluded in the analysis of the variables collected in this day.||steps||Standard Deviation|Mean
837435|NCT01298661|Primary|"Second Six Minute Step Test Performance"|"This test will be conducted by the Rater 1, the patient will step up and down a 20cm step during six minutes. The performance will be evaluated by the number of the climbs."|On the first or second day of evaluation (random), 30 minutes after the first 6MST.|2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.||steps||Standard Deviation|Mean
837436|NCT01298661|Primary|"First Six Minute Step Test Performance"|"This test will be conducted by the Rater 1, the patient will step up and down a 20cm step during six minute. The performance will be evaluated by the number of the steps."|First day or second day of the protocol (random)|2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.||steps||Standard Deviation|Mean
837437|NCT01298778|Other Pre-specified|Emetic Symptoms|side effect potential with the increased dose of duramorph-percentage experiencing such symptoms|24hours|percentage of patients reporting emetic symptoms requiring treatment||Participants|||Count of Participants
837438|NCT01298778|Other Pre-specified|Pruritus|side effects-percentage of subjects requiring treatment|24 hours|percentage of patients with pruritis requiring treatment.||Participants|||Count of Participants
837439|NCT01298778|Secondary|Average Pain Over 24 Hours||24 hours|VAS pain score of 0=no pain at all up to 100 being worst pain imaginable.||units on a scale||Standard Deviation|Mean
837440|NCT01298778|Secondary|Incidence of Depression|to determine whether an intervention in women predicted to experience severe pain after cesarean delivery reduces postpartum depression up to 2 months post delivery.|2 months|||Participants|||Count of Participants
837441|NCT01298778|Secondary|Analgesic Consumption|total amount of analgesic consumption|24 hour|||mg||Inter-Quartile Range|Median
837442|NCT01298778|Secondary|Pain|resting pain, worst pain|24 hour|||units on a scale, 0 -none, 100-worst||Inter-Quartile Range|Median
837443|NCT01298778|Secondary|Incidence of Persistent Pain|to determine whether an intervention in women predicted to experience severe pain after cesarean delivery reduces persistent pain up to 2 months post delivery.|2 months|||percentage of participants|||Number
837444|NCT01298778|Primary|Severity of Acute Pain|to determine whether an intervention in women predicted to experience severe pain after cesarean delivery reduces acute post-delivery pain (24 hour evoked pain post delivery). The scale utilized was a 100mm sliding VAS, where 0mm=no pain up to 100mm-worst pain imaginable.|24 hour|||mm||Standard Deviation|Mean
837445|NCT01299025|Secondary|Change in the 12 Item Walking Scale From Day 1 to Day 42|The 12 item walking scale is a self-rating scale of walking limitations. The scale includes 12 items that each are scores from 1 to 5, where 5 is extremely limited. Scores are added and transformed to a scale from 0-100. 0 indicates no limitation and 100 extremely limited.|Measured at day 1 and day 42, before and after the training|||Scores on a scale||Standard Deviation|Mean
837446|NCT01299025|Secondary|Change in the Activities-specific Balance Confidence (ABC) Scalefrom Day 1 to Day 42|The ABC scale is a self-rating scale of balance activities in everyday Life. It includes 16 items. The patient rates his/her performance from 0-100. Score on each item are summed an divided by 16. Minimum score is 0 and maximum score 100. A higher score indicate higher confidence in ones balance and walking capacity.|Measured at day 1 (before training) and day 42 (after training)|||Scores on a scale||Standard Deviation|Mean
837449|NCT01299077|Secondary|Visual Analogue Scale (VAS) Score|Each patient is Scored on VAS at baseline and two weeks. VAS is the abbreviation of visual analogue score. There is no subscale in VAS. The maximum value of vas is 10 and the minimum is 0. This is self-evaluation method to present the severity of patient pain. More score number, more pain.|Baseline and 2 weeks|The primary analysis will be on the Per-protocol (PP) population. PP population includes all subjects who received the dose of study drug without protocol deviation and had all the assessment per protocol.||Scores on VAS||Standard Deviation|Mean
837450|NCT01299077|Secondary|Japanese Orthopedic Association (JOA) Score|"Each patient is Scored on JOA at baseline and two weeks. JOA is short for Japanese Orthopedic Association, which consists of 12 items: low back pain, lower extremity pain and numbness, walking ability, straight leg raising, muscle strength, sensory and etc. The first 3 item’s scores are range from 0 to 3 and the others are from 0 to 2. Higher score means better condition.
All of these items scores are combined for a total overall JOA score, which is range from 0 to 27."|Baseline and 2 weeks|The primary analysis will be on the Per-protocol (PP) population. PP population includes all subjects who received the dose of study drug without protocol deviation and had all the assessment per protocol.||Scores on JOA||Standard Deviation|Mean
837451|NCT01299077|Secondary|Safety Data During Triple Therapy.|Percentage of participants with reported Adverse Events (AE) and Serious Adverse Event (SAE)|2 weeks|The primary analysis will be on the Per-protocol (PP) population. PP population includes all subjects who received the dose of study drug without protocol deviation and had all the assessment per protocol.||Percentage of participants|||Number
837452|NCT01299077|Secondary|Onset Time of Symptom Relief.|Kaplan-Meier Estimates for the Average Onset Time of Symptom Relief. In this case the onset time of symptom relief was defined as the days between the end of triple therapy and the symptom improvement reported by patients.|2 weeks|The primary analysis will be on the Per-protocol (PP) population. PP population includes all subjects who received the dose of study drug without protocol deviation and had all the assessment per protocol.||Average Days of Onset Time||Standard Deviation|Mean
837453|NCT01299077|Primary|Overall Satisfaction Degree After 2 Weeks Treatment of Triple Therapy (MBL+MYO+NSAID).|The measurement of overall satisfaction degree was in three scales, that was satisfactory, just so so and dissatisfactory. The measurement was estimated by both the physicians and the patients respectively.|2 weeks|The primary analysis will be on the Per-protocol (PP) population. PP population includes all subjects who received the dose of study drug without protocol deviation and had all the assessment per protocol.||percentage of participants|||Number
837454|NCT01299090|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|The rate of adverse events will be assessed throughout the duration of the study|90 days post treatment|||participants|||Number
837455|NCT01299090|Primary|Change in Neck and Facial Wrinkles Using the Fitzpatrick Wrinkle Assessment|"Three independent investigators blinded to photography time points will perform retrospective evaluations of photography from all visits using the 9-point Fitzpatrick Wrinkle Assessment Scale for assessment of neck and facial wrinkles at the culmination of the study.
The measurement is for percentage of patients who showed improvement"|90 days post treatment|||percentage of participants|||Number
837456|NCT01299103|Primary|Adverse Events|The rate of adverse events occurring in treatment subjects will be assessed.|90 days post treatment|||number of adverse events reported|||Number
837457|NCT01299103|Primary|Fitzpatrick Wrinkle Assessment|Subject photos will be evaluated using the 9-point Fitzpatrick Wrinkle Assessment Scale at all follow up visits. An improvement is noted by a decrease in the numeric Fitzpatrick Wrinkle score. The Fitzpatrick Wrinkle Assessment ranges from 1-9. Wrinkle Score between baseline and 90 days post treatment assessment. Positive values indicates an increase in score, while negative values indicate a decrease|change in Fitzpatrick Wrinkle Score between baseline and 90 days post treatment assessment.|||units on a scale, change in Fitzpatrick||Standard Deviation|Mean
837458|NCT01299285|Secondary|Percentage of Total Radioactivity of LY3009104 and LY3009104 Metabolites in Plasma||Baseline up to 24 hours|Participants who took study drug.||percentage of total radioactivity|||Number
837459|NCT01299285|Secondary|Percentage of Dose of LY3009104 and LY3009104 Metabolites in Feces|Percentages of LY3009104 (parent) and LY3009104 metabolites that were excreted in the feces are reported. Only those metabolites that were detectable in the feces are included in the report.|Baseline up to 72 hours|Participants who took study drug.||percentage of dose|||Number
837460|NCT01299285|Secondary|Percentage of Dose of LY3009104 and LY3009104 Metabolites in Urine|Percentages of LY3009104 (parent) and LY3009104 metabolites that were excreted in the urine are reported. Only those metabolites that were detectable in the urine are included in the report.|Baseline up to 48 hours|Participants who took study drug.||percentage of dose|||Number
837461|NCT01299285|Secondary|Plasma Pharmacokinetics: LY3009104 and Radioactivity Time to Maximum Observed Concentration (Tmax)||Baseline up to 48 hours|Participants who took study drug.||hour||Full Range|Median
837462|NCT01299285|Secondary|Plasma Pharmacokinetics: Maximum Observed Radioactivity Concentration (Cmax)||Baseline up to 48 hours|Participants who took study drug.||nanomole-equivalents/milliliter||Geometric Coefficient of Variation|Geometric Mean
837463|NCT01299285|Secondary|Plasma Pharmacokinetics: Maximum Observed LY3009104 Concentration (Cmax)||Baseline up to 48 hours|Participants who took study drug.||nanomoles/liter (nmol/L)||Geometric Coefficient of Variation|Geometric Mean
837464|NCT01299285|Secondary|Plasma Pharmacokinetics: Radioactivity Area Under the Concentration-Time Curve From Time Zero to Infinity [AUC(0-∞)]||Baseline up to 48 hours|Participants who took study drug.||hour*nanomole-equivalents/kilogram||Geometric Coefficient of Variation|Geometric Mean
837465|NCT01299285|Secondary|Plasma Pharmacokinetics: LY3009104 Area Under the Concentration-Time Curve From Time Zero to Infinity [AUC(0-∞)]||Baseline up to 48 hours|Participants who took study drug.||hour*nanomoles/liter(h*nmol/L)||Geometric Coefficient of Variation|Geometric Mean
837466|NCT01299285|Primary|Percentage of the Total Radioactive Dose Administered Excreted From Urine and Feces||Baseline up to 120 hours|Participants who took study drug.||percentage of total radioactivity||Standard Deviation|Mean
837499|NCT01299454|Secondary|Fraction of Systemically Available Brexpiprazole Excreted Into the Urine (fe,u)|"Urine samples were taken at pre-dose and during the following increments: 0 to 24, 24 to 48, 48 to 72, 72 to 96, 96 to 120, 120 to 144, and 144 to 168 hours postdose..
The value of fe,u was calculated as 100 × Ae,u/Dose."|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.||% of drug in urine||Standard Deviation|Mean
837467|NCT01299376|Secondary|Change in Trough Sitting Systolic Blood Pressure (SiSBP)-Double-Blind Treatment Period|Sitting systolic blood pressure was measured by automated sphygmomanometer pre-dose on Day 1 (baseline) and at 24 ± 2 hours after the last study drug administration at Week 8.|Baseline and Week 8|All participants that received at least one dose of study treatment during double-blind treatment period , had at least 1 post-randomization observation for the analysis endpoint, and had baseline data||mmHg||95% Confidence Interval|Least Squares Mean
837468|NCT01299376|Primary|Percentage of Participants Who Had Study Drug Discontinued From the Study Due to an AE- Long Term|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants who had study drug discontinued during the 44 week extension due to an AE regardless of completion status were summarized.|Week 9 up to Week 52 for L50/H12.5→L50/H12.5/A5 arm; Week 1 to Week 52 for L50/H12.5/A5→L50/H12.5/A5|All randomized participants who received at least 1 dose of study drug during extension period.||Percentage of Participants|||Number
837469|NCT01299376|Primary|Percentage of Participants Who Experience 1 or More Drug-related SAEs- Long Term|An SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. the percentage of participants that experienced an SAE that assessed as possibly, probably, or definitely related to the study drug by the investigator was summarized.|Week 9 up to Week 52 for L50/H12.5→L50/H12.5/A5 arm; Week 1 to Week 52 for L50/H12.5/A5→L50/H12.5/A5|All randomized participants who received at least 1 dose of study drug during long-term reporting period.||Percentage of Participants|||Number
837470|NCT01299376|Primary|Percentage of Participants Who Experience 1 or More SAEs- Long Term|An SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. Those SAEs assessed as possibly, probably, or definitely related to the study drug during the long-term period were summarized.|Week 9 up to Week 52 for L50/H12.5→L50/H12.5/A5 arm; Week 1 to Week 52 for L50/H12.5/A5→L50/H12.5/A5|All randomized participants who received at least 1 dose of study drug during long-term reporting period.||Percentage of Participants|||Number
837471|NCT01299376|Primary|Percentage of Participants Who Experience 1 or More Drug-related AEs- Long Term|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. Percentage of participants that experienced at least 1 AE that was reported as possibly, probably, or definitely related to the study drug by the investigator during the long-term reporting period was summarized.|Week 9 up to Week 52 for L50/H12.5→L50/H12.5/A5 arm; Week 1 to Week 52 for L50/H12.5/A5→L50/H12.5/A5|All randomized participants who received at least 1 dose of study drug during long-term reporting period.||Percentage of Participants|||Number
837472|NCT01299376|Primary|Percentage of Participants Who Experience 1 or More Adverse Events (AEs)- Long Term|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants that experienced at least 1 AE during long-term period was summarized.|Week 9 up to Week 52 for L50/H12.5→L50/H12.5/A5 arm; Week 1 to Week 52 for L50/H12.5/A5→L50/H12.5/A5|All randomized participants who received at least 1 dose of study drug during long-term reporting period.||Percentage of Participants|||Number
837473|NCT01299376|Primary|Percentage of Participants Who Had Study Drug Discontinued Due to an AE - Double Blind Treatment Period|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants who had study drug stopped during the 8-week double-blind treatment period due to an AE regardless of whether or not they completed the study was summarized by treatment arm.|up to Week 8|All randomized participants who received at least 1 dose of study drug during double-blind treatment period.||Percentage of Participants|||Number
837474|NCT01299376|Primary|Percentage of Participants Who Experience 1 or More Drug-Related Serious Adverse Events (SAEs)- Double-Blind Treatment Period|An SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. Percentage of participants that experienced at least 1 SAE that was reported as possibly, probably, or definitely related to the study drug by the investigator during the 8-week double-blind treatment period were summarized by study drug received.|up to Week 8|All randomized participants who received at least 1 dose of study drug during double-blind treatment period.||Percentage of Participants|||Number
837475|NCT01299376|Primary|Percentage of Participants Who Experience 1 or Serious Adverse Events (SAEs)- Double-Blind Treatment Period|An SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. The percentage of participants who experienced at least 1 SAE during the 8-week double-blind treatment period were summarized by study drug received.|up to Week 8|All randomized participants who received at least 1 dose of study drug during double-blind treatment period.||Percentage of Participants|||Number
837476|NCT01299376|Primary|Percentage of Participants Who Experience 1 or More Drug-Related AEs- Double-Blind Treatment Period|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. Percentage of participants that experienced at least 1 AE that was reported as possibly, probably, or definitely related to the study drug by the investigator during the 8-week double-blind treatment period were summarized by study drug received.|up to Week 8|All randomized participants who received at least 1 dose of study drug during double-blind treatment period.||Percentage of Participants|||Number
837477|NCT01299376|Primary|Percentage of Participants Who Experience 1 or More Adverse Events (AEs)- Double-Blind Treatment Period|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants who experienced at least 1 AE during the 8-week double-blind treatment period were summarized by study drug received.|up to Week 8|All randomized participants who received at least 1 dose of study drug during double-blind treatment period.||Percentage of Participants|||Number
837478|NCT01299376|Primary|Change in Trough Sitting Diastolic Blood Pressure (SiDBP)-Double-Blind Treatment Period|Sitting diastolic blood pressure was measured by automated sphygmomanometer pre-dose on Day 1 (baseline) and at 24 ± 2 hours after the last study drug administration at Week 8. The difference between the baseline and Week 8 assessments was calculated and summarized by treatment arm.|Baseline and Week 8|All participants that received at least one dose of study treatment during double-blind treatment period , had at least 1 post-randomization observation for the analysis endpoint, and had baseline data||mmHg||95% Confidence Interval|Least Squares Mean
837479|NCT01299389|Secondary|Change From Baseline in PANSS General Psychopathology Subscale Score at Week 13 or Early Discontinuation|General Psychopathology (range 16-112): Sum of scores for somatic concern, anxiety, guilt feelings, tension, mannerisms/posturing, depression, motor retardation, uncooperativeness, unusual thought content, disoriented, poor attention, lack of judgment/insight, disturbance of volition, poor impulse control, preoccupation, and active social avoidance, higher scores indicate worsening.|Baseline and Week 13 or early discontinuation|FAS population included all randomly assigned participants who received at least 1 injection of double-blind study drug and had baseline and at least 1 post-baseline PANSS total scores. LOCF method was used.||units on a scale||Standard Deviation|Mean
837480|NCT01299389|Secondary|Change From Baseline in PANSS Positive Subscale Score at Week 13 or Early Discontinuation|Positive Syndrome Scale (range 7-49): Sum of scores for items 1-7 in positive subscale: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility, higher scores indicate worsening.|Baseline and Week 13 or early discontinuation|FAS population included all randomly assigned participants who received at least 1 injection of double-blind study drug and had baseline and at least 1 post-baseline PANSS total scores. LOCF method was used.||units on a scale||Standard Deviation|Mean
837481|NCT01299389|Secondary|Change From Baseline in PANSS Negative Subscale Score at Week 13 or Early Discontinuation|Negative Syndrome Scale (range 7-49): Sum of scores for items 1-7 in negative subscale: blunted effect, emotional withdrawal, poor rapport, passive apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking, higher scores indicate worsening.|Baseline and Week 13 or early discontinuation|FAS population included all randomly assigned participants who received at least 1 injection of double-blind study drug and had baseline and at least 1 post-baseline PANSS total scores. LOCF method was used.||units on a scale||Standard Deviation|Mean
837482|NCT01299389|Secondary|Change From Baseline in PANSS Marder Subscale Scores at Week 13 or Early Discontinuation|The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). Positive symptoms subscale consists of 8 items with total score range of 8-56; negative symptoms subscale and disorganized thoughts subscale, each consists of 7 items with total score range of 7-49, uncontrolled hostility/excitement subscale and anxiety/depression subscale, each consists of 4 items with total score range of 4-28, higher score indicates greater severity.|Baseline and Week 13 or early discontinuation (ED)|FAS population included all randomly assigned participants who received at least 1 injection of double-blind study drug and had baseline and at least 1 post-baseline PANSS total scores. LOCF method was used.||units on a scale||Standard Deviation|Mean
837483|NCT01299389|Secondary|Participants With Response to the Treatment as Per PANSS Total Score.|Participants with response were defined as those participants who shows 30 percent or more and 20 percent or more reduction in PANSS total score.|up to Week 13 or early discontinuation|FAS population included all randomly assigned participants who received at least 1 injection of double-blind study drug and had baseline and at least 1 post-baseline PANSS total scores. LOCF method was used.||participants|||Number
837484|NCT01299389|Secondary|Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 13 or Early Discontinuation|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants, higher scores indicate worsening."|Baseline and Week 13 or early discontinuation|FAS population included all randomly assigned participants who received at least 1 injection of double-blind study drug and had baseline and at least 1 post-baseline PANSS total scores. LOCF method was used.||units on a scale||Full Range|Median
837500|NCT01299454|Secondary|Cumulative Amount of Brexpiprazole Excreted Into the Urine (Ae,u)|"Urine samples were taken at pre-dose and during the following increments: 0 to 24, 24 to 48, 48 to 72, 72 to 96, 96 to 120, 120 to 144, and 144 to 168 hours postdose.
The value of Ae,u was calculated as the summation of urine concentration × urine volume from each collection interval"|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.||ng||Standard Deviation|Mean
837485|NCT01299389|Primary|Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 13 or Early Discontinuation|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210, higher scores indicate worsening.|Baseline and Week 13 or early discontinuation|Full Analysis Set (FAS) population included all randomly assigned participants who received at least 1 injection of double-blind study drug and had baseline and at least 1 post-baseline PANSS total scores. Last Observation Carried Forward (LOCF) method was used.||units on a scale||Standard Deviation|Mean
837486|NCT01299454|Secondary|Incidence of Suicidality, Suicidal Behaviour or Suicidal Ideation as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)|The Baseline version of the C-SSRS was administered at Screening. The Since Last Visit version of the C-SSRS was administered on Day 1 at predose and on Days 4 and 7.|Day 1, Day 4, Day 7|Suicidality, suicidal behaviour or suicidal ideation are captured as serious AEs/AEs and are reported in the SAE or other AE section of this results report.||Participants|||Number
837487|NCT01299454|Secondary|Number of Participants With Changes From Baseline in Serum Chemistry, Hematology and Urinalysis Parameters.|Hematology, serum chemistry, and urinalysis, including prothrombin time, international normalized ratio, partial thromboplastin time, and activated partial thromboplastin time, were completed at Screening, Day -1, Day 3 (48 hours postdose), and Day 8 (168 hours postdose)/ET.|Day -1 to Day 8|The abnormal values of laboratory values in participants are captured as serious AEs/AEs and are reported in the SAE or other AE section of this results report.||Participant|||Number
837488|NCT01299454|Secondary|Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Parameters.|Electrocardiograms were performed at Screening, Day -1, and Day 1 at predose (in triplicate; within 45 minutes prior to dosing), and 2, 4, 6, 8, 12, 24, 72, 120, and 168/ET hours postdose. Standard 12-lead ECGs were performed after the subject was supine and at rest for ≥ 10 minutes prior to the ECG.|Day-1 to Day 8|The abnormal values of ECG values in participants are captured as serious AEs/AEs and are reported in the SAE or other AE section of this results report.||Participants|||Number
837489|NCT01299454|Secondary|Number of Participants With Changes From Baseline in Vital Signs Parameters.|Vital signs (including blood pressure, heart rate, temperature, and respiratory rate) were assessed at Screening, Day -1, Day 1 at predose (within 45 minutes prior to dosing), and 2, 4, 6, 8, 12, 24, 72, 120, and 168/ET hours postdose. Blood pressure and heart rate were taken with the subject in the supine (performed first), sitting, and standing|Day -1 to Day 8|The abnormal values of vital signs values in participants are captured as serious AEs/AEs and are reported in the SAE or other AE section of this results report.||Participants|||Number
837490|NCT01299454|Secondary|Number of Adverse Events (AEs) Reported|AEs were captured for all participants from the time the ICF was signed until the end of the study|From the time the Informed Consent Form was signed, throughout the 8 day study up to 30 days after study drug administration.|Participants who received at least one dose of study drug were included in the safety analysis.||Events|||Number
837491|NCT01299454|Secondary|CLr for DM-3411 Metabolite|"Urine samples were taken at pre-dose and during the following increments: 0 to 24, 24 to 48, 48 to 72, 72 to 96, 96 to 120, 120 to 144, and 144 to 168 hours postdose.
The value of CLr was calculated as Ae,u/AUCt."|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.||mL/h/kg||Standard Deviation|Mean
837492|NCT01299454|Secondary|fe,u for DM-3411 Metabolite|"Urine samples were taken at pre-dose and during the following increments: 0 to 24, 24 to 48, 48 to 72, 72 to 96, 96 to 120, 120 to 144, and 144 to 168 hours postdose.
The value of fe,u was calculated as 100 × Ae,u/Dose."|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.||% metabolite excreted in urine||Standard Deviation|Mean
837493|NCT01299454|Secondary|Ae,u for DM-3411 Metabolite|"Urine samples were taken at pre-dose and during the following increments: 0 to 24, 24 to 48, 48 to 72, 72 to 96, 96 to 120, 120 to 144, and 144 to 168 hours postdose.
The value of Ae,u was calculated as the summation of urine concentration × urine volume from each collection interval."|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.||ng||Standard Deviation|Mean
837494|NCT01299454|Secondary|t1/2,z for DM-3411 Metabolite|"Blood samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose/ET.
The t1/2,z was determined as (ln2)/λz."|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.||h||Standard Deviation|Mean
837495|NCT01299454|Secondary|Tmax for DM-3411 Metabolite|Blood samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose/ET. Tmax is the time taken to reach highest measured concentration of the metabolite during the dosing interval.|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.||h||Full Range|Median
837496|NCT01299454|Secondary|Cmax for DM-3411 Metabolite|Blood samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose/ET. Cmax is the highest measured concentration of the metabolite during the dosing interval.|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.||ng/mL||Standard Deviation|Mean
837497|NCT01299454|Secondary|AUC∞ for DM-3411 Metabolite|"Blood samples were taken at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose/ET.
The AUC∞ were estimated using the linear trapezoidal rule."|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.||ng*h/mL||Standard Deviation|Mean
837498|NCT01299454|Secondary|AUCt for DM-3411 Metabolite|"Blood samples were taken at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose/ET.
AUCt= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)
The AUCt was estimated using the linear trapezoidal rule."|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.||ng*h/mL||Standard Deviation|Mean
837502|NCT01299454|Secondary|Terminal-phase Elimination Half-life of Brexpiprazole (t1/2,z)|"Blood samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose/ET.
The t1/2,z was determined as (ln2)/λz.
Terminal-phase elimination half-life is the time measured for the plasma concentration to decrease by one half."|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.||h||Standard Deviation|Mean
837503|NCT01299454|Secondary|Apparent Unbound Clearance of Brexpiprazole From Plasma After Extravascular Administration (CLu/F)|"Blood samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose/ET.
The value of CLu/F (brexpiprazole only) was determined as dose normalized unbound area under the concentration-time curve from time zero to infinity (Dose/AUC∞,u)."|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.||mL/h/kg||Standard Deviation|Mean
837504|NCT01299454|Secondary|Unbound Fraction of Brexpiprazole in Plasma (fu)|Blood samples were taken at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose/ET.|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.||% unbound drug in the urine||Standard Deviation|Mean
837505|NCT01299454|Secondary|Apparent Clearance of Brexpiprazole From Plasma After Extravascular Administration (CL/F)|"The value of CL/F (brexpiprazole only) was determined as Dose/AUC∞.
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood."|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.||mL/h/kg||Standard Deviation|Mean
837506|NCT01299454|Secondary|Time to Cmax of Brexiprazole (Tmax)|"Blood samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose/ET.
Tmax is the time taken to reach highest measured concentration of the drug during the dosing interval.
Actual blood sample times were used for PK calculations. Values for Cmax and tmax were determined directly from the observed data."|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.||h||Full Range|Median
837507|NCT01299454|Secondary|Maximum Plasma Concentration of Brexpiprazole (Cmax)|"Blood samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose/ET.
Cmax is the highest measured concentration of the drug during the dosing interval.
Actual blood sample times were used for PK calculations. Values for Cmax and tmax were determined directly from the observed data."|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.||ng/mL||Standard Deviation|Mean
837508|NCT01299454|Secondary|Area Under the Concentration Time Curve of Brexpiprazole From Time Zero to Infinity (AUC∞)|"Blood samples were taken at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose/ET.
AUC (0 - ∞)= AUC from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
The AUC∞ was estimated using the linear trapezoidal rule"|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.||ng*h/mL||Standard Deviation|Mean
837509|NCT01299454|Secondary|Area Under the Curve of Brexpiprazole Calculated to the Last Observable Concentration at Time t (AUCt)|"Blood samples were taken at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose/ET.
AUCt= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t) The AUCt was estimated using the linear trapezoidal rule."|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.||ng*h/mL||Standard Deviation|Mean
837510|NCT01299454|Primary|Unbound Maximum Plasma Concentration of Brexpiprazole (Cmax,u)|"Blood samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose/ET.
Cmax,u is the highest measured unbound plasma concentration during the dosing interval."|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.||ng/mL||Standard Deviation|Mean
837511|NCT01299454|Primary|Unbound Brexpiprazole AUC Calculated From Time Zero to Infinity (AUC∞,u)|"Blood samples were taken at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose/ET.
AUC (0 - ∞)= AUC from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞)."|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.||ng*h/mL||Standard Deviation|Mean
837512|NCT01299454|Primary|Unbound Brexpiprazole Area Under the Concentration Time Curve (AUC) Calculated to the Last Observable Concentration at Time t (AUCt,u)|Blood samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose/Early termination (ET).|Day 1 to Day 8|Pharmacokinetics (PK) set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.||nanograms.hours/mL (ng*h/mL)||Standard Deviation|Mean
837513|NCT01299480|Other Pre-specified|Percentage of Participants Achieving At Least 4-fold Increase in hSBA Titer||1 month after Injection 2, 3, 4|Results were not reported because a decision was made a priori that, although the fold rise outcome measure will still be performed, it will not be performed as a secondary outcome measure. Therefore it was moved from a secondary outcome measure in an earlier protocol version to an exploratory outcome measure in the final protocol.|||||
837514|NCT01299480|Secondary|Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level||Before Injection 1, 1 Month after Injection 2, 3, 4|||percentage of participants|||Number
837515|NCT01299480|Secondary|Percentage of Participants Achieving hSBA Titer >=LLOQ||Before Injection 1, 1 Month after Injection 2, 3, 4|||percentage of participants|||Number
837516|NCT01299480|Secondary|Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs)||Before Injection (Inj) 1, 1 Month (M) after (aft) Injection 2, 3, 4|||titer||95% Confidence Interval|Geometric Mean
837517|NCT01299480|Secondary|Percentage of Participants Achieving hSBA Titer >=LLOQ: Group 3 Participants||1 month after Injection 4|||percentage of participants|||Number
837518|NCT01299480|Primary|Percentage of Participants Reporting At Least 1 Adverse Event (AE)||Injection 1 up to 1 month after Injection 4|Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.||percentage of participants|||Number
837519|NCT01299480|Primary|Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation: Group 1 and 2 Participants||1 month after Injection 4|||percentage of participants|||Number
837520|NCT01305200|Other Pre-specified|Ancillary Validation Study of ChIMES||Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.|Analysis is not performed at this time due to no available funding and no human resource allocated to this study.|||||
837521|NCT01305200|Secondary|Severity of Mucositis|Area Under the Curve of Severity of Mucositis. According to mouth pain categorical rating scale ranges 0-10 with higher scores reflecting more severe pain.|Day -1 (day prior to stem cell infusion) to Day 20 following transplantation|Evaluable patients defined as patients with ≥11 daily WHO assessments.||units on a scale * day||Standard Deviation|Mean
837522|NCT01305200|Secondary|Incidence of Invasive Bacterial Infections|Invasive Bacterial Infection = yes|Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.|Total of 210 patients evaluable for this assessment (106 Arm I & 104 Arm II).||percentage of participants|||Number
837523|NCT01305200|Secondary|Incidence of Febrile Neutropenia|Fever and Neutropenia = yes|Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.|Total of 210 patients evaluable for this assessment (106 Arm I & 104 Arm II).||percentage of participants|||Number
837524|NCT01305200|Secondary|Duration of Total Parenteral Nutrition (TPN) Administration.|Mean days of total parenteral nutrition (TPN) administration.|Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.|Total of 210 patients evaluable for this assessment (106 Arm I & 104 Arm II).||Number of days||Standard Deviation|Mean
837525|NCT01305200|Secondary|Incidence of Total Parenteral Nutrition (TPN) Administration.|Total Parenteral Nutrition = yes|Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.|Total of 210 patients evaluable for this assessment (106 Arm I & 104 Arm II).||percentage of participants|||Number
837526|NCT01305200|Secondary|Total Dose of Parenteral Opioid Analgesic Used (Morphine Equivalents).|Morphine equivalent dose in mg/kg/day|Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.|Total of 210 patients evaluable for this assessment (106 Arm I & 104 Arm II).||mg/kg/day of opioid analgesics||Full Range|Median
837527|NCT01305200|Secondary|Duration of Parenteral Opioid Analgesic Use (Morphine Equivalents).|Mean days of parenteral opioid analgesic use.|Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.|Total of 210 patients evaluable for this assessment (106 Arm I & 104 Arm II).||Days||Standard Deviation|Mean
837528|NCT01305200|Secondary|Incidence of Parenteral Opioid Analgesic Use (Morphine Equivalents).|Opioid Administration = yes|Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.|Total of 210 patients evaluable for this assessment (106 Arm I & 104 Arm II)||percentage of participants|||Number
837529|NCT01305200|Secondary|Oral Mucositis Daily Questionnaire (OMDQ)|Area under the curve (AUC) of the Oral Mucositis Daily Questionnaire (OMDQ) subscales|Day -1 (day prior to stem cell infusion) to Day 20 following transplantation|Evaluable patients defined as patients with ≥11 daily WHO assessments.||units on a scale * day||Standard Deviation|Mean
837530|NCT01305200|Secondary|Incidence of Severe Oral Mucositis|Percentage of patients with Severe Oral Mucositis (WHO Grade 3 or 4) per arm.|Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.|Evaluable patients defined as patients with >= 11 daily WHO assessments.||percent of patients|||Number
837531|NCT01305200|Primary|Duration of Severe Oral Mucositis (WHO Grade 3 or 4)|Mean days of severe (WHO Grade 3 or 4) Mucositis.|Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.|Evaluable patients defined as patients with >= 11 daily WHO assessments.||Number of days||Standard Deviation|Mean
837538|NCT01305239|Secondary|Event-free Survival|Event-free survival: time between first intake of exemestane and date of last follow-up or date of death for deceased participants (date of relapse or death or last follow-up minus first intake date) + 1 / 365.25 * 12.|Baseline, every 6 months until adjuvant hormonal therapy stopped or up to 5 years of therapy completed|ITT population = all participants who received at least 1 dose of study drug and had at least 1 follow-up questionnaire completed. N = number of participants with analyzable (non-missing) data.||months||95% Confidence Interval|Mean
837540|NCT01305239|Secondary|Percentage of Participants Who Were Compliant With Treatment|Compliant with treatment = followed treatment regimen with exemestane according to initial prescription.|Baseline, every 6 months until adjuvant hormonal therapy stopped or up to 5 years of therapy completed|Safety set. Information on compliance was not available for subjects who did not have a follow-up visit. N = number of participants with analyzable data.||percentage of participants||95% Confidence Interval|Number
837541|NCT01305239|Secondary|Reasons for Discontinuation of Aromasin Therapy||Baseline, every 6 months until adjuvant hormonal therapy stopped or up to 5 years of therapy completed|Safety set. N = number of participants with follow-up visit(s) who discontinued treatment with exemestane.||participants|||Number
837542|NCT01305239|Primary|Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Any untoward medical occurrence in a patient who received study drug was considered an adverse event without regard to possibility of causal relationship. An adverse event resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a serious adverse event: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline, every 6 months until adjuvant hormonal therapy stopped or up to 5 years of therapy completed|Safety set: all participants who received at least 1 dose of study medication.||percentage of participants|||Number
837543|NCT01305252|Secondary|B-type Natriuretic Peptide (BNP)|B-type Natriuretic peptide measures the percent change from baseline.|Baseline and 24 weeks|||percent change||Standard Deviation|Mean
837544|NCT01305252|Secondary|Change in NYHA/WHO Class|"At 48 week,WHO/NYHA functional class was assessed for change in WHO/NYHA functional class.Change NYHA is measured as decrease or increase in NYHA class in the subjects compared with baseline.
NYHA /WHO functional class is described below:
NYHA functional class I:no symptoms and no limitation in ordinary physical activity NYHA functional class II:Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity NYHA functional class III:Marked limitation in activity due to symptoms, even during less-than-ordinary activity NYHA functional class IV:Severe limitations. Experiences symptoms even while at rest A higher functional class represent worse symptoms."|Baseline and 48 week|||participants|||Number
837545|NCT01305252|Secondary|N-terminal Pro B-type Natriuretic Peptide (NT-proBNP)|Change from baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP)|Baseline and 24 weeks|||pg/mL||Standard Deviation|Mean
837546|NCT01305252|Secondary|6 Minute Walk Distance|Change in 6MWD during 24 week period compared between Tada and Tada+iTre.|Baseline and 24 weeks|||meters||Inter-Quartile Range|Mean
837547|NCT01305252|Primary|Change in Right Ventricular Ejection Fraction|Effect of dual-upfront therapies versus mono-therapy on percent change of right ventricular function assesed by cardiac MRI (cMRI) at 24 weeks compared with the baseline.|Basline and 24 weeks|||percent change||Inter-Quartile Range|Mean
837548|NCT01305265|Primary|Incidence of Tracheopharyngeal Symptoms||within 2 hours after extubation|||participants|||Number
837549|NCT01305408|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Specific Plan and Intent Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.
The Suicidal Ideation - Specific Plan and Intent question records whether the participant has active suicidal thoughts of killing oneself with details of plan fully or partially worked out and the participant has some intent to carry out the plan since the last visit."|Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. This question is asked if the answer to the 'Non-Specific Active Suicidal Thoughts' question was YES, or based on the judgment of the assessor. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
837550|NCT01305408|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Some Intent to Act Without a Specific Plan Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.
The Suicidal Ideation - Some Intent to Act Without a Specific Plan question records whether the participant has active suicidal thoughts of killing oneself and reports having some intent to act on such thoughts since the last visit."|Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. This question is asked if the answer to the 'Non-Specific Active Suicidal Thoughts' question was YES, or based on the judgment of the assessor. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
837551|NCT01305408|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Any Methods (Not Plan) Without Intent to Act Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.
The Suicidal Ideation - Any Methods (Not Plan) Without Intent to Act question records whether the participant endorses thoughts of suicide and has thought of at least one method but has no specific plan of action since the last visit."|Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. This question is asked if the answer to the 'Non-Specific Active Suicidal Thoughts' question was YES, or based on the judgment of the assessor. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
837576|NCT01305473|Secondary|Procedural Time for Sepramesh Placement.|Procedure time will be defined as beginning when the Investigator made the initial incision and ending when the skin closure was completed (skin to skin).|Day 0|All enrolled subjects were included in the analysis.||minutes||Standard Deviation|Mean
837552|NCT01305408|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Non-Specific Active Suicidal Thoughts Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.
The Suicidal Ideation - Non-Specific Active Suicidal Thoughts question records whether the participant shares general non-specific thoughts of wanting to end one's life/commit suicide since the last visit."|Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
837553|NCT01305408|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Wish to Be Dead Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.
The Suicidal Ideation - Wish to Be Dead question records whether the participant endorses thoughts about a wish to dead or not alive anymore, or a wish to fall asleep and not wake up since the last visit."|Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
837554|NCT01305408|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Completed Suicide Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.
The Suicidal Behavior - Completed Suicide question records whether the participant intentionally causing his/her's own death since the last visit."|Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
837555|NCT01305408|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Preparatory Acts or Behavior Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.
The Suicidal Behavior - Preparatory Acts or Behavior question records whether the participant exhibited acts or preparations towards imminently making a suicide attempt since the last visit."|Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
837556|NCT01305408|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Suicidal Behavior Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.
The Suicidal Behavior - Suicidal Behavior question records whether in the clinician's opinion, the participant exhibited suicidal behavior since the last visit."|Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
837557|NCT01305408|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Aborted Attempt Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.
The Suicidal Behavior - Aborted Attempt question records whether the participant began to take steps toward making a suicide attempt but stops themselves before starting the potentially self-injurious act since the last visit."|Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
837558|NCT01305408|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Interrupted Attempt Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.
The Suicidal Behavior - Interrupted Attempt question records whether the participant was interrupted by an outside circumstance from starting the potentially self-injurious act with at least some wish to die since the last visit."|Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
837734|NCT01308476|Secondary|Patients Compliance With SMS System|Compliance was defined as the percentage of patients answers to the IVR system as compared to the number of SMS automatically sent to the patients by the SMS/ IVR system asking for the number of Spiriva HandiHaler applications.|24 weeks|FAS||Percentage of participants answers||Standard Deviation|Mean
837559|NCT01305408|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Non-Suicidal Self-Injurious Behavior Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.
The Suicidal Behavior - Non-Suicidal Self-Injurious Behavior question records whether the participant committed a potentially self-injurious act that was not associated with a wish to die since the last visit."|Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
837560|NCT01305408|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Actual Attempt Question|The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Actual Attempt question records whether the participant committed a potentially self-injurious act with at least some wish to die since the last visit.|Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
837561|NCT01305408|Secondary|Change From Baseline to Endpoint in the Insomnia Severity Index (ISI) Total Score|The ISI is a participant-rated, 7-item questionnaire designed to assess the severity of the participant's insomnia. Each item is ranked 0 (none) through 4 (very severe) and has a descriptor associated with each severity level. Total range is 0 (no insomnia) to 28 (very severe insomnia). Responses to each item are added to obtain a total score to determine the severity of insomnia. Negative change from baseline scores indicate a decrease in severity of insomnia.|Day 0 (baseline), last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with both baseline and during treatment assessments.||units on a scale||Standard Deviation|Mean
837562|NCT01305408|Secondary|Change From Baseline to Endpoint in the Hamilton Anxiety Scale (HAM-A) Total Score|HAM-A measures the severity of anxiety symptoms. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Negative change from baseline scores indicate a decrease in severity of anxiety.|Day 0 (baseline), last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with both baseline and during treatment assessments.||units on a scale||Standard Deviation|Mean
837563|NCT01305408|Secondary|Change From Baseline to Endpoint in the Young Mania Rating Scale (YMRS) Total Score|The YMRS is a clinician-rated, 11-item checklist used to measure the severity of manic episodes. Information for assigning scores is gained from the participant's subjective reported symptoms over the previous 48 hours and from clinical observation during the interview. Seven items are ranked 0 through 4 and have descriptors associated with each severity level. Four items (irritability, speech, content, and disruptive-aggressive behavior) are scored 0 through 8 and have descriptors for every second increment. The total scale is 0-60. A score of ≤12 indicates remission of manic symptoms, and higher scores indicate greater severity of mania. Negative change from baseline scores indicate a decrease in severity of mania.|Day 0 (baseline), last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with both baseline and during treatment assessments.||units on a scale||Standard Deviation|Mean
837564|NCT01305408|Secondary|Participants With Treatment-Emergent Adverse Events (TEAE)|"AEs were graded by the investigator for severity on a three-point scale: mild, moderate and severe. Causality is graded as either related or not related. A serious adverse event (SAE) is an AE resulting in death, a life-threatening adverse event, hospitalization, a persistent or significant disability/incapacity, a congenital anomaly/birth defect, or an important medical event that may require medical intervention to prevent any of the previous results.
Protocol-defined adverse events requiring expedited reporting included skin rash, hypersensitivity reaction, emergent suicidal ideation or suicide attempt, and psychosis."|Day 1 to Week 9|The safety analysis set includes randomized participants who took 1 or more doses of study drug.||participants|||Number
837565|NCT01305408|Secondary|Change From Baseline to Weeks 4, 8 and Endpoint in the Global Assessment for Functioning (GAF) Scale|The Global Assessment of Functioning (GAF) is a numeric scale (1 through 100) used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of adults, e.g., how well or adaptively one is meeting various problems-in-living. Ratings of 1 - 10 mean the participant is in persistent danger of severely hurting self or others (e.g., recurrent violence) or persistent inability to maintain minimal personal hygiene or serious suicidal act with clear expectation of death. Ratings of 91 - 100 indicate no symptoms, and the participant exhibits superior functioning in a wide range of activities, life's problems never seem to get out of hand, is sought out by others because of his or her many positive qualities. Positive change from baseline values indicate improvement in functioning.|Day 0 (baseline), Weeks 4, 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The number of participants is those with a nonmissing value at that visit. Endpoint was the last observed postbaseline data.||units on a scale||Standard Deviation|Mean
837735|NCT01308476|Secondary|Response Rate Regarding Adherence|Adherence was dichotomised into yes and no at the end of study depending on whether the percentage of adherence was at least 80 percent or less than 80 percent, respectively. Patients who did not respond to the SMS/ IVR system to provide information about the actual number of inhalations were considered with 0 percent adherence.|24 weeks|FAS||Percentage of participants|||Number
837566|NCT01305408|Secondary|Change From Baseline to Different Treatment Weeks in the Clinical Global Impression of Severity (CGI-S) for Depression|The CGI-S is an observer-rated scale that measures illness severity on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). Negative change from baseline values indicate improvement in the severity of depression.|Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The number of participants is those with a nonmissing value at that visit. Endpoint was the last observed postbaseline data.||units on a scale||Standard Deviation|Mean
837567|NCT01305408|Secondary|Change From Baseline to Different Treatment Weeks in the Total Score From the 16-Item Quick Inventory of Depressive Symptomatology-Clinician-Rated (QIDS-C16)|The QIDS-C16 was derived from specified items in the IDS-C30, clinician-rated scale to assess the severity of a participant's depressive symptoms. Total scores range from 0-27, with a score of 0 indicating no depression and a score of 27 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression.|Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The number of participants at each visit are those with a nonmissing value at that visit. Endpoint was the last observed postbaseline data.||units on a scale||Standard Deviation|Mean
837568|NCT01305408|Secondary|Change From Baseline to Different Treatment Weeks in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)|"The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.
Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression."|Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. Participants are included in the analysis at each timepoint if they have a nonmissing value at that visit. Endpoint for analyses was the last observed postbaseline data.||units on a scale||Standard Deviation|Mean
837569|NCT01305408|Secondary|Percentage of Participants in Remission At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score|"A participant in remission was defined as a participant with an IDS-C30 total score of 11 or less.
The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.
Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression."|Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The denominator for calculating the percentages at each visit is the number of participants with a nonmissing value at that visit. Endpoint was the last observed postbaseline data.||percentage of participants|||Number
837570|NCT01305408|Secondary|Percentage of Responders At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score|"A responder is a participant with a ≥50% decrease or greater from baseline in the total score of the IDS-C30. The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.
Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression."|Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The denominator for calculating the percentages at each visit is the number of participants with a nonmissing value at that visit. Endpoint was the last observed postbaseline data.||percentage of participants|||Number
837571|NCT01305408|Primary|Change From Baseline to Week 8 in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)|"The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.
Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression."|Day 0 (baseline), Week 8|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
837572|NCT01305473|Post-Hoc|Hernia Recurrence Rate Post Repair With Sepramesh in Subjects With Both Incisional and Umbilical Hernias|A recurrent hernia is a hernia (either umbilical or incisional), confirmed by the Investigator at any point after surgery, in the same location as the hernia repaired in the index procedure.|12 months or greater|This analysis included the 5 subjects who underwent surgery to repair both incisional and umbilical hernias in the index procedure.||participants|||Number
837573|NCT01305473|Post-Hoc|Hernia Recurrence Rate of Umbilical Hernias Post Repair With Sepramesh.|A recurrent umbilical hernia is an umbilical hernia, confirmed by the Investigator at any point after the surgery, in the same location as the umbilical hernia that was repaired in the index procedure.|12 months or greater|The analysis population included the 43 subjects who underwent surgery to repair umbilical hernias in the index procedure.||participants|||Number
837574|NCT01305473|Post-Hoc|Hernia Recurrence Rate of Incisional Hernias Post Repair With Sepramesh.|A recurrent incisional hernia is an incisional hernia, confirmed by the Investigator at any point after the surgery, in the same location as the incisional hernia that was repaired in the index procedure.|12 months or greater|The analysis population included the 42 subjects who underwent surgery to repair incisional hernias in the index procedure.||participants|||Number
837575|NCT01305473|Secondary|Recovery Time Associated With Hernias Repaired With Sepramesh.|Recovery time will be defined as the time it took for the subject to return to work.|12 months or greater (average follow-up time of 3 years; range 13-65 months)|Data not available: none of the subject medical records reported return to work data. Secondary endpoint analysis could not be performed.|||||
837577|NCT01305473|Secondary|Complications in Subjects With Hernias Repaired With Sepramesh.|Complications will be assessed by evaluation of the procedural and device related adverse events (AEs) documented in the subject’s medical files from the time surgery was initiated until the day the subject had a postoperative visit (that is, the protocol specified postoperative visit for conducting a physical examination).|12 months or greater (average follow-up time of 3 years; range 13-65 months)|All enrolled subjects were included in the analysis.||participants|||Number
837578|NCT01305473|Primary|Hernia Recurrence Rate of Hernias Post Repair With Sepramesh.|A recurrent hernia is a hernia, confirmed by the Investigator at any point after the surgery, in the same location as the hernia repaired in the index procedure.|12 months or greater (average follow-up time of 3 years; range 13-65 months)|All enrolled subjects were included in the analysis.||participants|||Number
837579|NCT01306214|Secondary|Change From Baseline in HbA1c After 52 Weeks of Treatment|The secondary endpoint was the change from baseline in HbA1c after 52 weeks of treatment|Baseline and 52 weeks|Per Protocol Set (PPS) - completers at week 52 - using LOCF at week 52 (LOCF-52)||percentage of HbA1c||Standard Error|Least Squares Mean
837580|NCT01306214|Secondary|Change From Baseline in Body Weight After 52 Weeks of Treatment|The secondary endpoint was the change from baseline in body weight after 52 weeks of treatment|Baseline and 52 weeks|Per Protocol Set (PPS) - completers at week 52 - using LOCF at week 52 (LOCF-52)||kg||Standard Error|Least Squares Mean
837581|NCT01306214|Secondary|Change From Baseline in Insulin Dose After 52 Weeks of Treatment|The secondary endpoint is change from baseline in insulin dose after 52 weeks of treatment|Baseline and 52 weeks|Per Protocol Set-patients in FAS without important protocol violations leading to exclusion, completed minimum treatment of 357 days and did not prematurely discontinue. Values after start of antidiabetic rescue therapy (week 52 definition) were set to missing and last observation carried forward (LOCF-52) was used for imputation of missing values.||IU/day||Standard Error|Least Squares Mean
837582|NCT01306214|Primary|Change From Baseline in HbA1c After 18 Weeks of Treatment|The primary endpoint was the change from baseline in HbA1c after 18 weeks of treatment.|Baseline and 18 weeks|The analysis was conducted on the full analysis set (FAS) of patients. Values after start of antidiabetic rescue therapy (week 18 definition) were set to missing and last observation carried forward (LOCF-18) was used for imputation of missing values.||percentage of HbA1c||Standard Error|Least Squares Mean
837583|NCT01306253|Secondary|Numbers of Subjects Reporting Solicited Systemic Adverse Events|Safety assessments are made by the investigator at baseline and on Day 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination|Days 1 to 4 inclusive, and Day 22|Safety population||Subjects|||Number
837584|NCT01306253|Primary|Fold Increase in Geometric Mean Titer (GMT)|GMT-fold increase - calculated as the GMT on Day 22 divided by the baseline GMT value|Day 22/Day 1|ITT/ATP||Fold (ratio)|||Number
837585|NCT01306253|Primary|Seroprotection|Seroprotection rate, defined as the number of subjects with HI antibody titer ≥1:40|Day 22 ± 2 days|ITT/ATP||Number of subjects|||Number
837586|NCT01306253|Secondary|Safety: Numbers of Subjects Reporting Solicited Local Adverse Events|Safety assessments are made by the investigator at baseline and on Day 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination|Days 1 to 4 inclusive, and Day 22|Safety population includes all subjects who received study vaccine||Subjects|||Number
837587|NCT01306253|Primary|Seroconversion|Seroconversion rate was defined as the number of subjects with ≥4-fold increase in haemagglutination inhibition (HI) antibody titer and with a titer of ≥1:40|Day 22 ± 2 days|Intention-to-treat (ITT) and According-to-protocol (ATP) populations excludes one subject per group lost to follow up||Number of subjects|||Number
837588|NCT01306292|Primary|Effects of SonoVue and Placebo on Pulmonary Hemodynamics: Pulmonary Vascular Resistance (Dyne*Sec/cm^5) - Mean Change From Baseline|All subjects in this study were to have pulmonary vascular resistance (PVR; measured in dyne x seconds per centimeters to the 5th power) derived from mean PAP (measured in mmHg), pulmonary capillary wedge pressure (PCWP [mmHg]) and cardiac output (Qp [litres per minute]), each taken 5 minutes prior to the first investigational product administration, calculated using the following formula: [(mean PAP-PCWP) divided by Qp] x 80. Baseline is the last measurement prior to first investigational product administration, therefore, applying to both products. Mean PAP, PCWP and Qp were repeated at 1 and 10 minutes post dose; PVR was calculated.|Comparison to baseline to 2 post dose timepoints (1 and 10 minutes post dose)|36 total subjects: 18 subjects (8 assigned to placebo/SonoVue and 10 assigned to SonoVue/placebo) in the Baseline mean PAP >=25.0 mmHg group (Hypertension Group) and 18 subjects (10 assigned to placebo/SonoVue and 8 assigned to SonoVue/placebo) in the Baseline mean PAP <25.0 mmHg group (Normal Group).||dyne*sec/cm^5||Standard Deviation|Mean
837589|NCT01306292|Primary|Effects of SonoVue and Placebo on Pulmonary Hemodynamics: Diastolic Pulmonary Artery Pressure (mmHg) - Mean Change From Baseline|All subjects in this study were to have diastolic PAP recorded within 5 minutes before the first investigational product administration. This parameter was to be measured and recorded again at 1, 4, 7 and 10 minutes after the administration of each investigational product (SonoVue and Placebo). This outcome measure presents the mean change from baseline in diastolic PAP measured in mmHg. Baseline is the average of the 2 measurements within 5 minutes prior to first investigational product administration, therefore, applying to both products.|Comparison to baseline to 4 post dose timepoints (1, 4, 7 and 10 minutes post dose)|36 total subjects: 18 subjects (8 assigned to placebo/SonoVue and 10 assigned to SonoVue/placebo) in the Baseline mean PAP >=25.0 mmHg group (Hypertension Group) and 18 subjects (10 assigned to placebo/SonoVue and 8 assigned to SonoVue/placebo) in the Baseline mean PAP <25.0 mmHg group (Normal Group).||mmHg||Standard Deviation|Mean
837603|NCT01306617|Secondary|Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) Post-Treatment|Sustained virologic response 24 (SVR24) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ; < 25 IU/mL) 24 weeks after the last dose of study drug.|Post-treatment Day 1 to Post-treatment Week 24|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT). Participants with missing data were imputed as failures.||percentage of participants|||Number
838095|NCT01311661|Secondary|Mean Pre-dose Morning PEF (PEF a.m.)|PEF a.m. was measured by patients at home using the AM3 device (overall means obtained during each period of randomised treatment will be compared). Means are adjusted for treatment, period, patient and study baseline.|0-3 weeks|FAS||Liter/min||Standard Error|Mean
837590|NCT01306292|Primary|Effects of SonoVue and Placebo on Pulmonary Hemodynamics: Systolic Pulmonary Artery Pressure (mmHg) - Mean Change From Baseline|A total of 36 subjects were enrolled in this crossover study: 18 (8 randomized to placebo then SonoVue and 10 randomized to SonoVue then placebo) in the Hypertension Group (baseline mean pulmonary artery pressure (PAP) >=25.0 mmHg group) and 18 (10 randomized to placebo then SonoVue and 8 randomized to SonoVue then placebo) in the Normal group (baseline mean PAP <25.0 mmHg group). All subjects in this study were to have systolic PAP recorded within 5 minutes before the first investigational product administration. This parameter was to be measured and recorded again at 1, 4, 7 and 10 minutes after the administration of each investigational product (SonoVue and Placebo). This outcome measure presents the mean change from baseline in systolic PAP measured in mmHg. Baseline is the average of the 2 measurements within 5 minutes prior to first investigational product administration, therefore, applying to both products.|Comparison to baseline to 4 post dose timepoints (1, 4, 7 and 10 minutes post dose)|36 total subjects: 18 subjects (8 assigned to placebo/SonoVue and 10 assigned to SonoVue/placebo) in the Baseline mean PAP >=25.0 mmHg group (Hypertension Group) and 18 subjects (10 assigned to placebo/SonoVue and 8 assigned to SonoVue/placebo) in the Baseline mean PAP <25.0 mmHg group (Normal Group).||mmHg||Standard Deviation|Mean
837591|NCT01306305|Secondary|Numbers of Subjects Reporting Solicited Systemic Adverse Events|Safety assessments are made by the investigator at baseline and on Days 8, 15 and 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination.|Days 1 to 4 inclusive, and Days 8, 15 and 22|Safety population||Subjects|||Number
837592|NCT01306305|Primary|Fold Increase in Geometric Mean Titer (GMT)|GMT-fold increase - calculated as the GMT on Day 22 divided by the baseline GMT value|Day 22/Day 1|ITT/ATP||Fold (ratio)|||Number
837593|NCT01306305|Primary|Seroprotection|Seroprotection rate, defined as the number of subjects with HI antibody titer ≥1:40|Day 22 ± 2 days|ITT/ATP||Number of subjects|||Number
837594|NCT01306305|Secondary|Safety: Numbers of Subjects Reporting Solicited Local Adverse Events|Safety assessments are made by the investigator at baseline and on Days 8, 15 and 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination.|Days 1 to 4 inclusive, and Days 8, 15 and 22|Safety population includes all subjects who received study vaccine||Subjects|||Number
837595|NCT01306305|Primary|Seroconversion|Seroconversion rate was defined as the number of subjects with ≥4-fold increase in haemagglutination inhibition (HI) antibody titer and with a titer of ≥1:40|Day 22 ± 2 days|Intention-to-treat (ITT) and According-to-protocol (ATP) populations excludes one subject lost to follow up and one subject who withdrew consent||Number of subjects|||Number
837596|NCT01306617|Secondary|Pharmacokinetics (C Trough) of Ribavirin in HCV Infected Participants|Trough concentration (C trough) is the concentration 24 hours after once daily (QD) dose and 12 hours after twice daily (BID) dose.|Day 1 to Week 12|Pharmacokinetic analyses included all participants who received at least 1 dose of the study drug (ITT) and for whom concentration data was available to characterize C trough.||nanograms (ng) per milliliter (mL)||Full Range|Geometric Mean
837597|NCT01306617|Secondary|Pharmacokinetics (C Trough) of Ritonavir in HCV Infected Participants|Trough concentration (C trough) is the concentration 24 hours after once daily (QD) dose and 12 hours after twice daily (BID) dose.|Day 1 to Week 12|Pharmacokinetic analyses included all participants who received at least 1 dose of the study drug (ITT) and for whom concentration data was available to characterize C trough.||nanograms (ng) per milliliter (mL)||Full Range|Geometric Mean
837598|NCT01306617|Secondary|Pharmacokinetics (C Trough) of ABT-333 in HCV Infected Participants|Trough concentration (C trough) is the concentration 24 hours after once daily (QD) dose and 12 hours after twice daily (BID) dose.|Day 1 to Week 12|Pharmacokinetic analyses included all participants who received at least 1 dose of the study drug (ITT) and for whom concentration data was available to characterize C trough.||nanograms (ng) per milliliter (mL)||Full Range|Geometric Mean
837599|NCT01306617|Secondary|Pharmacokinetics (C Trough) of ABT 450 in HCV Infected Participants|Trough concentration (C trough) is the concentration 24 hours after once daily (QD) dose and 12 hours after twice daily (BID) dose.|Day 1 to Week 12|Pharmacokinetic analyses included all participants who received at least 1 dose of the study drug (ITT) and for whom concentration data was available to characterize C trough.||nanograms (ng) per milliliter (mL)||Full Range|Geometric Mean
837600|NCT01306617|Secondary|Resistance-Associated Variants and Phenotypic Resistance|Baseline samples were analyzed for resistance-associated amino acid variants using population sequencing. Phenotypic resistance to ABT-450 or ABT-333 at baseline was assessed by calculating the fold difference in the half maximal effective concentration (EC50) compared with the EC50 for the appropriate reference replicon (1a-H77 or 1b-Con1). Participants not achieving SVR12 were analyzed for resistance-associated variants at the time of failure using population sequencing and were compared with the baseline and appropriate reference sequences to assess amino acid changes. Phenotypic resistance to ABT-450 or ABT-333 at the time of failure was assessed by calculating the fold difference in the EC50 compared with the EC50 for the corresponding baseline sample. The number of participants with variants at resistance-associated amino acid positions and phenotypic resistance at baseline and at the time of failure are presented.|Day 1 to post-treatment week 48|Resistance analyses included all participants who receive at least one dose of study drug (intent-to-treat [ITT] population).||participants|||Number
837601|NCT01306617|Secondary|Time to Virologic Relapse Post-treatment|Time to the first of 2 consecutive measurements of confirmed HCV RNA ≥ lower limit of quantitation (LLOQ) at any point in the post-treatment period among participants with HCV RNA < LLOQ at the end of treatment.|Post-treatment Day 1 to post-treatment week 48|All randomized participants who received at least 1 dose of study drug with HCV RNA < LLOQ at the final treatment visit who completed treatment.||days||Standard Error|Mean
837602|NCT01306617|Secondary|Time to Failure to Suppress or Rebound During Treatment|Time to failure to achieve a 2 log10 IU/mL HCV RNA decrease at Week 1, failure to achieve HCV RNA < Lower Limit of Detection (LLOD) at Week 6, or a confirmed increase of at least 0.5 log10 IU/mL above nadir (local minimum value) or confirmed HCV RNA > lower limit of quantitation (LLOQ) for participants who previously achieved HCV RNA < LLOQ.|Day 1 through Week 12|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).||days||Standard Error|Mean
837632|NCT01307046|Primary|Percentage of Participants Who Experienced at Least One Adverse Event (AE)||8 weeks|All-Patients-as-Treated (APaT) Population: defined as all randomized participants who received at least one dose of study treatment.||percentage of participants|||Number
837604|NCT01306617|Secondary|Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment|Sustained virologic response 12 (SVR12) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ; < 25 IU/mL) 12 weeks after the last dose of study drug.|Post-treatment Day 1 to Post-treatment Week 12|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT). Participants with missing data were imputed as failures.||percentage of participants|||Number
837605|NCT01306617|Secondary|Percentage of Participants With HCV RNA Below the Lower Limit of Quantitation (LLOQ; <25 IU/mL) at Week 4|Analysis of percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (< 25 IU/mL).|Week 4|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT). Participants with missing data were imputed as failures.||percentage of participants|||Number
837606|NCT01306617|Secondary|Percentage of Participants With HCV RNA < 1000 International Units Per Milliliter (IU/mL)|Analysis of participants with HCV RNA levels below 1000 IU/mL at Week 2.|Week 2|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT). Participants with missing data were imputed as failures.||percentage of participants|||Number
837607|NCT01306617|Primary|Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Suppressed Below the Lower Limit of Detection (LLOD) From Week 4 Through Week 12|Analysis of the percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of detection (< 15 IU/mL).|Week 4 through Week 12|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT). Participants with missing data were imputed as failures.||percentage of participants|||Number
837608|NCT01306643|Secondary|Changes in Liver Imaging as Assessed by Magnetic Resonance Imaging (MRI) and Gadoxetic Acid (GD-EOB-DTPA) Contrast||Up to twelve 28-day cycles (maximum of 12 months)|Data are not available because the samples and analysis results (performed at the sites) could not be retrieved by Gilead.|||||
837609|NCT01306643|Secondary|Changes in Concentration of Peripheral Blood Chemokines and Cytokines||Up to twelve 28-day cycles (maximum of 12 months)|Data are not available because the samples and analysis results (performed at the sites) could not be retrieved by Gilead.|||||
837610|NCT01306643|Secondary|Flow Cytometric Measurement of Tumoral and Peripheral Blood T and NK Cells||Up to twelve 28-day cycles (maximum of 12 months)|Data are not available because the samples and analysis results (performed at the sites) could not be retrieved by Gilead.|||||
837611|NCT01306643|Secondary|Flow Cytometric Measurement of Constitutive or Inducible Phosphorylation of Akt (at S473) and S6 Within Tumor B Cells||Up to twelve 28-day cycles (maximum of 12 months)|Data are not available because the samples and analysis results (performed at the sites) could not be retrieved by Gilead.|||||
837612|NCT01306643|Primary|Clinical Response: Overall Response Rate|"Participants were assessed for clinical response by appropriate imaging at the end of cycles 3, 6, 9, and 12.
Overall response rate (ORR) was assessed based on standardized criteria (Cheson 2007), and was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) based on investigator assessment after the start of idelalisib treatment until progression or the end of study drug treatment.
CR was defined as the disappearance of all evidence of disease.
PR was defined the regression of measurable disease and no new sites."|Up to twelve 28-day cycles (maximum of 12 months)|ITT Analysis Set||percentage of participants||95% Confidence Interval|Number
837613|NCT01306643|Primary|Overall Safety of Idelalisib|The overall safety of idelalisib was assessed as the percentage of participants experiencing treatment-emergent adverse events (AEs; Serious AEs, Grade ≥ 3 AEs, AEs related to idelalisib, and AEs leading to discontinuation of idelalisib).|30 days post last study treatment (up to 12 months)|Intent-to-treat (ITT) Analysis Set: all enrolled participants who received at least 1 dose of idelalisib.||percentage of participants|||Number
837614|NCT01306877|Secondary|Operative Room (OR) Time|Time of insertion of anoscope to time of anoscope removal after stapleline evaluation|Day 0|||minutes||Standard Deviation|Mean
837615|NCT01306877|Secondary|Length of Stay|Length of hospital stay is defined as time of anoscope insertion until discharge|Day 0 time of discharge minus time of admission|||Hours||Standard Deviation|Mean
837616|NCT01306877|Secondary|Location of the Staple Line|Distance of staple line to dentate line as measure by surgical ruler|Day 0|||mm||Standard Deviation|Mean
837617|NCT01306877|Secondary|Overall Quality of Life - General Health Score|Quality of life was measured by SF-12 questionnaire in change from baseline; the socring range is 0 - 100 with 0 = poor overall health and 100 = excellent overall health|Day 0 minus 60, 1 week, 1 month, 3 months, 6 months|||units on a scale||Standard Deviation|Mean
837618|NCT01306877|Secondary|Post-Operative Pain (Analgesic Intake)|post operative pain measured in pos-surgical consumption of strong opioids by the number of participants in the study. Participants are included if they consumed analgesics or strong opiod at anytime during the study.|Day 0, 1 week, 2 week, 1 month, 3 month, 6 month|||participants|||Number
837619|NCT01306877|Secondary|Post Operative Pain - (PI-NIRS)|"Post-operative pain as change from baseline pain score as measured by an 11-point Pain Intensity Numeric Rating Scale (PI-NRS). The range of the scale is 0-10 with 0 representing no pain and 10 representing the worst possible pain.
The data represented is the change in baseline score at the different timepoints."|Day 0 minus 60 (baseline), Day 0 (discharge), Day 0 plus 7, Day 0 plus 30, Day 0 plus 90, Day 0 plus 180|||units on a scale||Standard Deviation|Mean
837620|NCT01306877|Primary|Intraoperative Bleeding|Number of subjects who require intervention to stop intraoperative bleeding The analysis is based on the per protocol analysis set. Subjects who were misrandomized for excluded from this analysis therefore, the population here will differ from the participant flow.|Day 0 - time of surgery|||participants|||Number
837633|NCT01307046|Secondary|Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP)|Sitting systolic blood pressure was measured by automated sphygmomanometer pre-dose on Day 1 (baseline) and at 24 ± 2 hours after the last study drug administration (Day 56 ± 7 days).|Baseline and Week 8|"Full Analysis Set (FAS) Population: defined as all randomized participants who received at least one dose of study treatment, had at least one post-randomization observation for the analysis endpoint subsequent
to at least one dose of study treatment, and had baseline data for those analyses that required baseline data"||mmHg||95% Confidence Interval|Least Squares Mean
838147|NCT01305577|Secondary|Change From Baseline in Body Image Quality of Life Inventory (BIQLI)||Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)||01/2016||||
837621|NCT01306968|Primary|Change in Post-concussion Symptom Scores Using RPQ - Per Protocol Population|The Rivermead Post-Concussion Symptom Questionnaire (RPQ)/RPQ-3 was created to measure the severity of post-concussion symptoms following traumatic brain injury. The scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical outcome measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature.|Follow-up Visit 2; Day 56 (up to day 100) for groups not recieving HBO2, Day 70 for groups recieving HBO2|Per protocol population: Only those completing all 40 chamber sessions and outcomes testing are included in the per protocol population. The standard TBI care group remained the same as no champber sessions were use in this group.||units on a scale||Standard Deviation|Mean
837622|NCT01306968|Primary|Post-Intervation Post-concussion Symptom Scores Using RPQ - Per Protocol Population|The Rivermead Post-Concussion Symptom Questionnaire (RPQ)/RPQ-3 was created to measure the severity of post-concussion symptoms following traumatic brain injury. The scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical outcome measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature.|Follow-up Visit 2; Day 56 (up to day 100) for groups not recieving HBO2, Day 70 for groups recieving HBO2|Per protocol population: Only those completing all 40 chamber sessions and outcomes testing are included in the per protocol population. The standard TBI care group remained the same as no champber sessions were use in this group.||units on a scale||Standard Deviation|Mean
837623|NCT01306968|Primary|Change in Post-concussion Symptom Scores Using RPQ - Intent to Treat|Means for the change from baseline to follow-up visit 2|Follow-up Visit 2; Day 56 (up to day 100) for groups not recieving HBO2, Day 70 for groups recieving HBO2|Intent to treat population: All randomized participants were included in the intention-to-treat analysis||units on a scale||Standard Deviation|Mean
837624|NCT01306968|Primary|Post-Intervation Post-concussion Symptom Scores Using RPQ - Intent to Treat|The Rivermead Post-Concussion Symptom Questionnaire (RPQ)/RPQ-3 was created to measure the severity of post-concussion symptoms following traumatic brain injury. The scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical outcome measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature.|Follow-up Visit 2; Day 56 (up to day 100) for groups not recieving HBO2, Day 70 for groups recieving HBO2|Intent to treat population: All randomized participants were included in the intention-to-treat analysis.||units on a scale||Standard Deviation|Mean
837625|NCT01307007|Primary|Changes in Blood Markers|Changes in blood markers of phosphate|Day 35|||mg/dL||Standard Deviation|Mean
837626|NCT01307020|Secondary|Percentage of Patients Using Rescue Medication at 6 Hours|Percentage of patients using rescue medication at 6 hours post-dosing.|Baseline to 6 hours|ITT (intention to treat) population which was defined as all patients who have taken the study treatment and have at least 1 post-dose assessment||percentage of patients|||Number
837627|NCT01307020|Secondary|Percentage of Patients Achieving at Least 50 % of the Theoretical Maximum Total Pain Relief Score at 4, 8 and 12 Hours Post-dosing.|Pain relief is measured by a verbal rating scale (ranging from 0=none to 4=complete). Theoretical maximum TOTPAR at 6 hours is calculated by summing up the maximum score of analgesia which the patient can attribute at defined time points along 4, 8 and 12 hours(maxTOTPAR4h= 16, maxTOTPAR8h= 32 and maxTOTPAR12h= 48, respectively) Unit of measure is %|4, 8 and 12 hours|ITT (intention to treat) population which was defined as all patients who have taken the study treatment and have at least 1 post-dose assessment||percentage of patient|||Number
837628|NCT01307020|Primary|Percentage of Patients Achieving at Least 50 % of the Theoretical Maximum Total Pain Relief Score at 6 Hours Post-dosing.|Pain relief is measured by a verbal rating scale (ranging from 0=none to 4=complete). Theoretical maximum TOTPAR at 6 hours is calculated by summing up the maximum score of analgesia which the patient can attribute at defined time points along 6 hour (maxTOTPAR6h= 24). Unit of measure is %|6 hours|ITT (intention to treat) population which was defined as all patients who have taken the study treatment and have at least 1 post-dose assessment||percentage of patients|||Number
837629|NCT01307033|Primary|Percentage of Participants Who Experienced an Adverse Event When Receiving MK-0954A (L100/H12.5) During Study (8-week Double-blind and/or 44-week Open-label Extension)||Up to 52 weeks|All-Patients-as-Treated (APaT) Population, which consists of all randomized patients who received at least one dose of MK-0954A. The L100/H12.5 (L50/H12.5) arm only includes data from extension period (44 weeks); L100/H12.5→L100/H12.5 Open Label arm includes data from entire study period (52 weeks).||Percentage of Participants|||Number
837630|NCT01307033|Secondary|Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 8|Blood pressure (BP) was measured with an automatic sphygmomanometer after participant has been resting in a sitting position for at least 10 minutes. BP was determined averaging 3 replicate measurements obtained at least a 1- to 2-minute interval between BP measurements. The recorded BP was the calculated average of the 3 readings.|Baseline and Week 8 (End of Double-blind Period)|Full Analysis Set (FAS) population: defined as all randomized participants who received at least one dose of study treatment, had at least one post-randomization observation for the analysis endpoint subsequent to at least one dose of study treatment, and had baseline data for those analyses that required baseline data||mmHg||95% Confidence Interval|Least Squares Mean
837631|NCT01307033|Secondary|Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 8|Blood pressure (BP) was measured with an automatic sphygmomanometer after participant has been resting in a sitting position for at least 10 minutes. BP was determined averaging 3 replicate measurements obtained at least a 1- to 2-minute interval between BP measurements. The recorded BP was the calculated average of the 3 readings.|Baseline and Week 8 (End of Double-blind Period)|Full Analysis Set (FAS) population: defined as all randomized participants who received at least one dose of study treatment, had at least one post-randomization observation for the analysis endpoint subsequent to at least one dose of study treatment, and had baseline data for those analyses that required baseline data||mmHg||95% Confidence Interval|Least Squares Mean
838148|NCT01305577|Secondary|Change From Baseline in Derriford Appearance Scale 24 (DAS24)||Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)||01/2016||||
837634|NCT01307046|Primary|Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP)|Sitting diastolic blood pressure was measured by automated sphygmomanometer pre-dose on Day 1 (baseline) and at 24 ± 2 hours after the last study drug administration (Day 56 ± 7 days).|Baseline and Week 8|"Full Analysis Set (FAS) population: defined as all randomized participants who received at least one dose of study treatment, had at least one post-randomization observation for the analysis endpoint subsequent
to at least one dose of study treatment, and had baseline data for those analyses that required baseline data"||mmHg||95% Confidence Interval|Least Squares Mean
837635|NCT01307111|Primary|Patient Perceived Pain on a 100-point Visual Analogue Scale.|Perceived pain was registered on a 100-point visual analogue scale (0 = no pain, 100 = worst pain imaginable) at three time points: prior to IUD insertion, immediately after insertion, and prior to clinic discharge.|Prior to insertion, immediately after insertion, and prior to clinic discharge.|||units on a scale||Standard Deviation|Mean
837636|NCT01307111|Secondary|Provider Perceived Ease of Insertion on a 100-point Visual Analogue Scale.|Perceived ease of IUD insertion registered on a visual analogue scale (0 = easy, 100 = extremely difficult).|Immediately post IUD insertion|||units on a scale||Standard Deviation|Mean
837637|NCT01307319|Primary|Change From Baseline in the Average Morning (AM) and Evening (PM) Subject-Reported Reflective Total Nasal Symptom Score (rTNSS) During the Two Weeks of Treatment|"Reflective TNSS is an evaluation of symptom severity over the past 12 hours prior to the recording of the score. Participants (with assistance from parents/guardians/caregivers, as needed) assessed and recorded four nasal symptoms (runny nose, nasal congestion, nasal itching, and sneezing) twice daily (AM and PM) using the following scale:
0 = absent (no sign/symptom present)
1 = mild (sign/symptom clearly present, but minimal awareness; easily tolerated)
2 = moderate (definite awareness of sign/symptom that is bothersome but tolerable)
3 = severe (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping) The total TNSS scale was 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms.
Baseline was defined as the average AM and PM subject-reported rTNSS over the 4 days prior to randomization."|Baseline (Day -4 to Day 1 predose), Days 1 (postdose) to Day 15|The intent to treat (ITT) population included all randomized participants who received at least one dose of randomized study medication and had at least one post-baseline assessment. Two enrolled participants were excluded. One was randomized in error and did not receive test medication. The other provided no post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
837638|NCT01307319|Secondary|Change From Baseline in the Average Morning (AM) and Evening (PM) Subject-Reported Instantaneous Total Nasal Symptom Score (iTNSS) During the Two Weeks of Treatment|"Instantaneous TNSS is an evaluation of symptom severity over the last 10 minutes prior to the recording of the score. Participants (with assistance from parents/guardians/caregivers, as needed) assessed and recorded four nasal symptoms (runny nose, nasal congestion, nasal itching, and sneezing) twice daily (AM and PM) using the following scale:
0 = absent (no sign/symptom present)
1 = mild (sign/symptom clearly present, but minimal awareness; easily tolerated)
2 = moderate (definite awareness of sign/symptom that is bothersome but tolerable)
3 = severe (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping) The total TNSS scale was 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms.
Baseline was defined as the average AM and PM subject-reported iTNSS over the 4 days prior to randomization."|Baseline (Day -4 to Day 1 predose), Days 1 (postdose) to Day 15|The intent to treat (ITT) population included all randomized participants who received at least one dose of randomized study medication and had at least one post-baseline assessment. Two enrolled participants were excluded. One was randomized in error and did not receive test medication. The other provided no post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
837639|NCT01307423|Secondary|Number of Participants With Adverse Events||Up to 5 years||06/2018||||
837640|NCT01307423|Secondary|Percentage of Participants With Pre-existing Dactylitis Whose Dactylitis Severity Score Improves From Baseline to 0 at Week 52|Percentage of participants with pre-existing dactylitis whose dactylitis severity score improves to zero after 52 weeks. Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Baseline and Week 52||06/2018||||
837641|NCT01307423|Secondary|Percentage of Participants With Pre-existing Enthesopathy Whose MASES Improves From Baseline to 0 at Week 52|Percentage of participants with pre-existing enthesopathy whose MASES improves to 0 after 24 weeks. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Achilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses. Two-sided 95% confidence interval was based on the Clopper-Pearson method.|Baseline and Week 52||06/2018||||
837642|NCT01307423|Secondary|Percentage of Participants With an ACR 70 Response at Week 52|ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: ≥ 70% improvement in 78 tender joint count; ≥ 70% improvement in 76 swollen joint count; and ≥ 70% improvement in at least 3 of the 5 following parameters: Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Patient's global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); C-Reactive Protein. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Baseline and Week 52||06/2018||||
837705|NCT01307618|Primary|Absolute Number of CD4+CD25+FoxP3+ Regulatory T Cells From Peripheral Blood|Descriptive statistics and paired t-tests will be generated to describe the frequency and absolute number of CD4+CD25+FoxP3+ cells before and after daclizumab, and also at subsequent time points. Repeated measures of analysis of variance and mixed effects models will be used to further evaluate change in numbers over time, and to compare these changes between cohorts.|Up to 4 years|Due to lack of clinical efficacy and lack of drug supply, trial was closed early and absolute number of CD4+CD25+FoxP3+Regulatory T Cells from peripheral blood was not measured.|||||
837643|NCT01307423|Secondary|Percentage of Participants With an ACR 50 Response at Week 52|Percentage of participants with an American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: ≥ 50% improvement in 78 tender joint count; ≥ 50% improvement in 76 swollen joint count; and ≥ 50% improvement in at least 3 of the 5 following parameters: o Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Patient's global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); C-Reactive Protein. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Baseline and Week 52||06/2018||||
837644|NCT01307423|Secondary|Percentage of Participants Achieving Good or Moderate EULAR Response at Week 52|The EULAR response criteria classify each subject as a good, moderate or non-responder to treatment based on the degree of improvement from baseline and the level of disease activity at the endpoint. EULAR response is derived using the individual subject’s DAS28 as the measure of severity of disease. A Good response is defined as follows: Good response: DAS28 at the time point ≤ 3.2 and improvement from baseline > 1.2 A Moderate Response is defined as either: an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 score of less than or equal to 5.1 or, an improvement (decrease) in the DAS28 of more than 1.2 and attainment of a DAS28 score of greater than 3.2. Two-sided 95% confidence interval is based on the Clopper-Pearson method|Baseline and Week 52||06/2018||||
837645|NCT01307423|Secondary|Percentage of Participants With Pre-existing Dactylitis Whose Dactylitis Severity Score Improves From Baseline by ≥ 1 at Week 52|Percentage of participants with pre-existing dactylitis whose dactylitis severity score improved by ≥ 1 after 52 weeks. Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Baseline and Week 52||06/2018||||
837646|NCT01307423|Secondary|Percentage of Participants With MASES Improvement ≥ 20% at Week 52|Percentage of participants with pre-existing enthesopathy whose MASES improved by ≥ 20% from Baseline after 52 weeks. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Achilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Baseline and Week 52||06/2018||||
837647|NCT01307423|Secondary|Change From Baseline in the FACIT-Fatigue Scale Score at Week 52|"The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue. A positive change from baseline score indicates an improvement."|Baseline and Week 52||06/2018||||
837648|NCT01307423|Secondary|Change From Baseline in the DAS28 at Week 52|The DAS28 measures the severity of disease at a specific time and is derived from the following variables: • 28 tender joint count • 28 swollen joint count, which do not include the DIP joints, the hip joint, or the joints below the knee; • C-reactive protein (CRP) • Patient's global assessment of disease activity. DAS28(CRP) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission.|Baseline and Week 52||06/2018||||
837649|NCT01307423|Secondary|Change From Baseline in the CDAI Score at Week 52|The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the: 28 tender joint count (TJC), 28 swollen joint count (SJC), Patient's Global Assessment of Disease Activity measured on a 10 cm visual analog scale (VAS), where 0 cm = lowest disease activity and 10 cm = highest; Physician's Global Assessment of Disease Activity -measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest. The CDAI score ranges from 0-76 where lower scores indicate less disease activity. The following thresholds of disease activity have been defined for the CDAI: Remission: ≤ 2.8 Low Disease Activity: > 2.8 and ≤ 10 Moderate Disease Activity: > 10 and ≤ 22 High Disease Activity: > 22.|Baseline and Week 52||06/2018||||
837650|NCT01307423|Secondary|Change From Baseline in the Dactylitis Severity Score at Week 52|Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet will be rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present|Baseline and Week 52||06/2018||||
837651|NCT01307423|Secondary|Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 52|The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Achilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.|Baseline and Week 52||06/2018||||
837652|NCT01307423|Secondary|Change From Baseline in the Participants Assessment of Pain Using the Visual Analog Scale at Week 52|"The participant was asked to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents no pain, and the right-hand boundary (score = 100 mm) represents pain as severe as can be imagined. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 52||06/2018||||
838352|NCT01315158|Secondary|Compare Propofol Doses Between the Two Groups|The dose of propofol used between the two groups will be compared|One day (during procedure)|The data for this outcome measure was not collected and was not analyzed due to not having the necessary support to continue the study.|||||
837653|NCT01307423|Secondary|Percentage of Participants With a Modified PsARC Response at Week 52|Measure Description: Modified PsARC response is defined as improvement in at least 2 of the 4 measures, at least one of which must be tender joint count or swollen joint count, and no worsening in any of the 4 measures: • 78 tender joint count, • 76 swollen joint count, • Patient global assessment of disease activity, measured on a 100 mm visual Analog scale (VAS), where 0=lowest disease activity and 100=highest; • Physician global assessment of disease activity, measured on a 100 mm VAS, where 0=lowest disease activity and 100=highest. Improvement or worsening in joint counts is defined as decrease or increase, respectively, from baseline by ≥ 30%, and improvement or worsening in global assessments is defined as decrease or increase, respectively, from baseline by ≥ 20 mm VAS. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Baseline and Week 52||06/2018||||
837654|NCT01307423|Secondary|Change From Baseline in the SF-36v2 Physical Functioning Scale Score at Week 52|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.|Baseline and Week 52||06/2018||||
837655|NCT01307423|Secondary|Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 52|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 52||06/2018||||
837656|NCT01307423|Secondary|Percentage of Participants With a ACR 20 Response at Week 52|Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: ≥ 20% improvement in 78 tender joint count; ≥ 20% improvement in 76 swollen joint count; and ≥ 20% improvement in at least 3 of the 5 following parameters: Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Patient's global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); C-Reactive Protein. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Baseline and Week 52||06/2018||||
837657|NCT01307423|Secondary|Percentage of Participants Achieving a Dactylitis Score of Zero at Week 24|"Percentage of participants with pre-existing dactylitis whose dactylitis severity score improves to zero after 24 weeks of treatment.
Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present."|Baseline and Week 24|Full analysis set; participants with a baseline dactylitis severity score > 0 are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
837658|NCT01307423|Secondary|Percentage of Participants Achieving a MASES Score of Zero at Week 24|"Percentage of participants with pre-existing enthesopathy whose MASES improves to 0 after 24 weeks of treatment.
The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):
1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Achilles tendon left/right.
The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses."|Baseline and Week 24|Full analysis set; participants with a baseline MASES > 0 are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
837659|NCT01307423|Secondary|Percentage of Participants With Pre-existing Dactylitis Whose Dactylitis Severity Score Improves to 0 at Week 16|"Percentage of participants with pre-existing dactylitis whose dactylitis severity score improves to zero after 16 weeks of treatment.
Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present."|Baseline and Week 16|Full analysis set; participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
837674|NCT01307423|Secondary|Change From Baseline in Dactylitis Severity Score at Week 24|Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet will be rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Baseline and Week 24|Full analysis set. Participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) and at least 1 postbaseline value at or prior to Week 24 are included. LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||units on a scale||Standard Error|Least Squares Mean
837660|NCT01307423|Secondary|Percentage of Participants With Pre-existing Enthesopathy Whose Maastricht Ankylosing Spondylitis Entheses Score Improves to 0 at Week 16|"Percentage of participants with pre-existing enthesopathy whose MASES improves to 0 after 16 weeks of treatment. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):
1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Achilles tendon left/right.
The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses."|Baseline and Week 16|Full analysis set; participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
837661|NCT01307423|Secondary|Percentage of Participants With a ACR 70 Response at Week 24|"Percentage of participants with an American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:
≥ 70% improvement in 78 tender joint count;
≥ 70% improvement in 76 swollen joint count; and
≥ 70% improvement in at least 3 of the 5 following parameters: Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Patient's global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); C-Reactive Protein."|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
837662|NCT01307423|Secondary|Percentage of Participants With a ACR 50 Response at Week 24|"Percentage of participants with an American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:
≥ 50% improvement in 78 tender joint count;
≥ 50% improvement in 76 swollen joint count; and
≥ 50% improvement in at least 3 of the 5 following parameters: Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Patient's global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); C-Reactive Protein."|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
837663|NCT01307423|Secondary|Percentage of Participants With a ACR 70 Response at Week 16|"Percentage of participants with an American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:
≥ 70% improvement in 78 tender joint count;
≥ 70% improvement in 76 swollen joint count; and
≥ 70% improvement in at least 3 of the 5 following parameters: Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Patient's global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); C-Reactive Protein."|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
837664|NCT01307423|Secondary|Percentage of Participants With a ACR 50 Response at Week 16|"Percentage of participants with an American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:
≥ 50% improvement in 78 tender joint count;
≥ 50% improvement in 76 swollen joint count; and
≥ 50% improvement in at least 3 of the 5 following parameters: Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Patient's global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); C-Reactive Protein."|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.||Percentage of participants|||Number
837665|NCT01307423|Secondary|Percentage of Participants With Good or Moderate EULAR Response at Week 24|"The EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on th DAS-28.
Good or moderate response is defined as follows:
Good response: DAS28 at the time point ≤ 3.2 and improvement from baseline > 1.2 Moderate response: DAS28 at the time point > 3.2 and improvement from baseline > 1.2, or DAS28 at the time point ≤ 5.1 and improvement from baseline > 0.6 and ≤ 1.2
A Moderate Response is defined as either:
an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 score of less than or equal to 5.1 or,
an improvement (decrease) in the DAS28 of more than 1.2 and attainment of a DAS28 score of greater than 3.2."|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
837666|NCT01307423|Secondary|Percentage of Participants With Dactylitis Improvement ≥ 1 Point at Week 24|"Percentage of participants with pre-existing dactylitis whose dactylitis severity score improved by ≥ 1 after 24 weeks of treatment.
Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present."|Baseline and Week 24|Full analysis set; participants with a baseline dactylitis severity score > 0 are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
837667|NCT01307423|Secondary|Percentage of Participants With MASES Improvement ≥ 20% at Week 24|"Percentage of participants with pre-existing enthesopathy whose MASES improved by ≥ 20% from Baseline after 24 weeks of treatment. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):
1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Achilles tendon left/right.
The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses."|Baseline and Week 24|Full analysis set; participants with a baseline MASES > 0 are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
837668|NCT01307423|Secondary|Percentage of Participants With Good or Moderate European League Against Rheumatism (EULAR) Response at Week 16|"The EULAR response criteria classify each subject as a good, moderate or non-responder to treatment based on the degree of improvement from baseline and the level of disease activity at the endpoint. EULAR response is derived using the individual subject’s DAS28 as the measure of severity of disease. Good or moderate response is defined as follows:
Good response: DAS28 at the time point ≤ 3.2 and improvement from baseline > 1.2 Moderate response: DAS28 at the time point > 3.2 and improvement from baseline > 1.2, or DAS28 at the time point ≤ 5.1 and improvement from baseline > 0.6 and ≤ 1.2"|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
837669|NCT01307423|Secondary|Percentage of Participants With Dactylitis Improvement ≥ 1 Point at Week 16|"Percentage of participants with pre-existing dactylitis whose dactylitis severity score improved by ≥ 1 after 16 weeks of treatment.
Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present."|Baseline and Week 16|Full analysis set; participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
837670|NCT01307423|Secondary|Percentage of Participants With ≥ 20% Improvement in Maastricht Ankylosing Spondylitis Entheses Score at Week 16|"Percentage of participants with pre-existing enthesopathy whose MASES improved by ≥ 20% from Baseline after 16 weeks of treatment. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):
1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Achilles tendon left/right.
The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses."|Baseline and Week 16|Full analysis set; participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
837671|NCT01307423|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 24|"The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue. A positive change from baseline score indicates an improvement."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||units on a scale||Standard Error|Least Squares Mean
837672|NCT01307423|Secondary|Change in Disease Activity Score (DAS 28) at Week 24|"The DAS28 measures the severity of disease at a specific time and is derived from the following variables:
28 tender joint count
28 swollen joint count, which do not include the DIP joints, the hip joint, or the joints below the knee;
C-reactive protein (CRP)
Patient's global assessment of disease activity.
DAS28(CRP) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||units on a scale||Standard Error|Least Squares Mean
837673|NCT01307423|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 24|"The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:
28 tender joint count (TJC),
28 swollen joint count (SJC),
Patient's Global Assessment of Disease Activity measured on a 10 cm visual analog scale (VAS), where 0 cm = lowest disease activity and 10 cm = highest;
Physician's Global Assessment of Disease Activity -measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest.
The CDAI score ranges from 0-76 where lower scores indicate less disease activity.
The following thresholds of disease activity have been defined for the CDAI:
Remission: ≤ 2.8; Low Disease Activity: > 2.8 and ≤ 10; Moderate Disease Activity: > 10 and ≤ 22; High Disease Activity: > 22."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16||units on a scale||Standard Error|Least Squares Mean
837974|NCT01309997|Secondary|Patients With Any Percentage Decline in Any Grade of Sclerosis Without Increase in Percentage of Higher Grades of Sclerosis in Other Areas on the Vienna Skin Scale|Maximum of 10 body areas. Each area can be graded 0 (best) to 4 (worst). Each of those grades requires a percentage of involvement. Improvement is measured by reduction of involvement in any grade and any body area.|6 months|Only patients who were evaluable at 6mo are included.||participants|||Number
837675|NCT01307423|Secondary|Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 24|"The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):
1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Achilles tendon left/right.
The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses."|Baseline and Week 24|Full analysis set; participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||units on a scale||Standard Error|Least Squares Mean
837676|NCT01307423|Secondary|Change From Baseline in Participants Assessment of Pain at Week 24|"The participant was asked to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents no pain, and the right-hand boundary (score = 100 mm) represents pain as severe as can be imagined. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||mm||Standard Error|Least Squares Mean
837677|NCT01307423|Secondary|Percentage of Participants With a Modified Psoriatic Arthritis Response Criteria (PsARC) Response at Week 24|"Modified PsARC response is defined as improvement in at least 2 of the 4 measures, at least one of which must be tender joint count or swollen joint count, and no worsening in any of the 4 measures:
78 tender joint count,
76 swollen joint count,
Patient global assessment of disease activity, measured on a 100 mm visual Analog scale (VAS), where 0=lowest disease activity and 100=highest;
Physician global assessment of disease activity, measured on a 100 mm VAS, where 0=lowest disease activity and 100=highest.
Improvement or worsening in joint counts is defined as decrease or increase, respectively, from baseline by ≥ 30%, and improvement or worsening in global assessments is defined as decrease or increase, respectively, from baseline by ≥ 20 mm VAS."|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16, or who did not have sufficient data for a determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
837678|NCT01307423|Secondary|Change From Baseline in 36-item Short Form Health Survey (SF-36) Physical Functioning Domain at Week 24|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). SF-36 domain scores were first calculated to range from 0 to100 and then transformed to norm-based scores (the norm-based scores in the US general population have an average of 50 and a standard deviation of 10). Norm-based scores were used in analyses, with higher scores indicating a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from baseline score indicates an improvement.|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||units on a scale||Standard Error|Least Squares Mean
837679|NCT01307423|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 16|"The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue.
A positive change from baseline score indicates an improvement."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included. LOCF was used.||units on a scale||Standard Error|Least Squares Mean
837680|NCT01307423|Secondary|Change in Baseline in the Disease Activity Score (DAS28) After 16 Weeks of Treatment|"The DAS28 measures the severity of disease at a specific time and is derived from the following variables:
28 tender joint count
28 swollen joint count, which do not include the DIP joints, the hip joint, or the joints below the knee;
C-reactive protein (CRP)
Patient's global assessment of disease activity.
DAS28(CRP) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included. LOCF was used.||units on a scale||Standard Error|Least Squares Mean
837681|NCT01307423|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 16|"The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:
28 tender joint count (TJC),
28 swollen joint count (SJC),
Patient's Global Assessment of Disease Activity measured on a 10 cm visual analog scale (VAS), where 0 cm = lowest disease activity and 10 cm = highest;
Physician's Global Assessment of Disease Activity -measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest.
The CDAI score ranges from 0-76 where lower scores indicate less disease activity.
The following thresholds of disease activity have been defined for the CDAI:
Remission: ≤ 2.8 Low Disease Activity: > 2.8 and ≤ 10 Moderate Disease Activity: > 10 and ≤ 22 High Disease Activity: > 22"|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included. LOCF was used.||units on a scale||Standard Error|Least Squares Mean
837682|NCT01307423|Secondary|Change From Baseline in Dactylitis Severity Score at Week 16|Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet will be rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Baseline to Week 16|Full analysis set. Participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) and at least 1 postbaseline value at or prior to Week 16 are included. LOCF was used.||units on a scale||Standard Error|Least Squares Mean
837683|NCT01307423|Secondary|Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 16|"The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):
1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Achilles tendon left/right.
The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses."|Baseline and Week 16|Full analysis set; participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) and at least 1 postbaseline value at or prior to Week 16 are included; LOCF was used.||units on a scale||Standard Error|Least Squares Mean
837684|NCT01307423|Secondary|Change From Baseline in Patient’s Assessment of Pain at Week 16|"The participant was asked to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents no pain, and the right-hand boundary (score = 100 mm) represents pain as severe as can be imagined. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included; LOCF was used.||mm||Standard Error|Least Squares Mean
837685|NCT01307423|Secondary|Percentage of Participants With a Modified Psoriatic Arthritis Response Criteria (PsARC) Response at Week 16|"Modified PsARC response is defined as improvement in at least 2 of the 4 measures, at least one of which must be tender joint count or swollen joint count, and no worsening in any of the 4 measures:
78 tender joint count,
76 swollen joint count,
Patient global assessment of disease activity, measured on a 100 mm visual Analog scale (VAS), where 0=lowest disease activity and 100=highest;
Physician global assessment of disease activity, measured on a 100 mm VAS, where 0=lowest disease activity and 100=highest.
Improvement or worsening in joint counts is defined as decrease or increase, respectively, from baseline by ≥ 30%, and improvement or worsening in global assessments is defined as decrease or increase, respectively, from baseline by ≥ 20 mm VAS."|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
837686|NCT01307423|Secondary|Change From Baseline in 36-item Short Form Health Survey (SF-36) Physical Functioning Domain at Week 16|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). SF-36 domain scores were first calculated to range from 0 to100 and then transformed to norm-based scores (the norm-based scores in the US general population have an average of 50 and a standard deviation of 10). Norm-based scores were used in analyses, with higher scores indicating a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from baseline score indicates an improvement.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included; LOCF was used.||units on a scale||Standard Error|Least Squares Mean
837687|NCT01307423|Secondary|Change From Baseline in Health Assessment Questionnaire- Disability Index [HAQ-DI]) at Week 24|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16||units on a scale||Standard Error|Least Squares Mean
837688|NCT01307423|Secondary|Percentage of Participants With an ACR 20 Response at Week 24|"Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from baseline were met:
≥ 20% improvement in 78 tender joint count;
≥ 20% improvement in 76 swollen joint count; and
≥ 20% improvement in at least 3 of the 5 following parameters: Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Patient's global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); C-Reactive Protein."|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
837689|NCT01307423|Secondary|Change From Baseline in Health Assessment Questionnaire- Disability Index [HAQ-DI]) at Week 16|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative changes from baseline in the overall score indicate improvement in functional ability.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included; Last observation carried forward (LOCF) imputation was used.||units on a scale||Standard Error|Least Squares Mean
837706|NCT01307618|Primary|Frequency of Vaccine-induced CD8+ T Cells Assessed by Enzyme-linked Immunospot (ELISPOT)|Data before treatment and after 3 vaccines will be assessed using paired t-tests within each cohort as well as a two-sample t-test of the mean post-treatment levels between cohorts. Repeated measures analysis of variance or mixed effects models will be utilized to further characterize changes in the levels of circulating T cells over time.|Up to 4 years|Due to lack of clinical efficacy and lack of drug supply, trial was closed early and frequency of vaccine-induced CD8+T cells was not measured.|||||
837690|NCT01307423|Primary|Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 16|"A participant was a responder if the following 3 criteria for improvement from Baseline were met:
≥ 20% improvement in 78 tender joint count;
≥ 20% improvement in 76 swollen joint count; and
≥ 20% improvement in at least 3 of the 5 following parameters:
Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
Patient's global assessment of disease activity (measured on a 100 mm VAS);
Physician's global assessment of disease activity (measured on a 100 mm VAS);
Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));
C-Reactive Protein."|Baseline and Week 16|Full analysis set consisting of all participants randomized as specified in the protocol; one participant randomized in error and not receiving any dose of investigational product was excluded. Participants who withdrew early or did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
837691|NCT01307462|Secondary|Changes in Symptoms as Measured by Patient Self-report--Lee Chronic GVHD Symptom Scale|Lee symptom scale (LSS) has subscales with min=0, max=100; results are given as change in 6mo score compared to baseline score, not actual score, and a negative change is correlated with improvement in clinical outcome.|Baseline and 6 months|24 of 36 subjects were evaluable at 6mo due to missing patient survey data.||units on a scale||Full Range|Median
837692|NCT01307462|Secondary|Changes in Symptoms as Measured by Patient Self-report--Human Activities Profile (HAP)|"HAP subscales have min=0 and max=94; results are given as change in 6mo score compared to baseline score, not actual score, and a positive change is correlated with improvement in clinical outcome.
Maximum Activity Score (MAS) is highest item number answered still doing. Represents highest oxygen demanding activity that respondent still performs.
Adjusted Activity Score (AAS) is MAS minus total number of stopped doing responses below MAS. A measure of usual daily activities.
Modified AAS is MAS minus total number of stopped doing responses below MAS but not penalized for not doing activities not permitted post transplant. The following items are not counted against the score:11,15,19,20,22,25,34,41,42,47,49,50,52,53,54,57,72,73,77,78."|Baseline and 6 months|24 of 36 subjects were evaluable at 6mo due to missing patient survey data.||units on a scale||Full Range|Median
837693|NCT01307462|Secondary|Changes in Symptoms as Measured by Patient Self-report--Functional Assessment of Chronic Illness Therapy (FACT)|"FACT-BMT subscales have various min/max, see below; results are given as change in 6mo score compared to baseline score, not actual score, and a positive change is correlated with improvement in clinical outcome.
FACT physical well-being (0-28) FACT social/family well-being (0-28) FACT emotional well-being (0-24) FACT functional well-being (0-28) FACT Bone Marrow Transplant (BMT) subscale (0-40) FACT trial outcome index (0-96) FACT-General (G) (0-108) FACT-BMT total (0-148)"|Baseline and 6 months|24 of 36 subjects were evaluable at 6mo due to missing patient survey data.||units on a scale||Full Range|Median
837694|NCT01307462|Secondary|Changes in Symptoms as Measured by Patient Self-report--Short Form-36 (SF-36)|SF-36 subscales have min=0 and max=100; results are given as change in 6mo score compared to baseline score, not actual score, and a positive change is correlated with improvement in clinical outcome.|Baseline and 6 months|24 of 36 subjects were evaluable at 6mo due to missing patient survey data.||units on a scale||Full Range|Median
837695|NCT01307462|Secondary|Number of Subjects Were Able to Reduce Their Systemic Steroid Exposure by >=50%||Baseline to 6 months|24 out of 36 subjects were evaluable at 6mo due to missing data.||Participants|||Count of Participants
837696|NCT01307462|Secondary|Number of Subjects With Improvements in Other Chronic GVHD Characteristics|Only includes subjects who had complete or partial response according to the National Institute of Health (NIH) consensus criteria.|Baseline and 3 months|33 of 36 participants were evaluable at 3 months due to missing provider survey data||Participants|||Count of Participants
837697|NCT01307462|Secondary|Changes in Blood Molecular Markers: IL8 (Azithromycin), Cysteinyl and LTB4 (Monteleukast), and IL1B, TNF, and IL6, as Well as Neutrophil Count (Fluticasone)||Baseline to 6 months|Data were not collected|||||
837698|NCT01307462|Secondary|Number of Subjects Who Experienced Statistically Significant Changes in FVC, TLC, RV, DLCO||Baseline and 6 months|||Participants|||Count of Participants
837699|NCT01307462|Secondary|Number of Subjects Who Experienced Grade 3-5 SAEs Attributable to FAM and Number of Subjects Who Stopped FAM as a Result|National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) (v4.0)|From baseline to 6 months|||Participants|||Count of Participants
837700|NCT01307462|Primary|Number of Subjects Who Failed Treatment|Treatment failure is defined as sustained, absolute decrease (worsening) of the FEV1 by >= 10% predicted in comparison to the baseline FEV1. Must be confirmed by a second PFT 2 weeks after the first measurement.|Within 3 months after initiation of study medications|||Participants|||Count of Participants
837701|NCT01307618|Secondary|Gene Expression Profiles|Gene cluster analysis will be performed using deoxyribonucleic acid (DNA)-Chip Analyzer (dCHIP) software and comparisons will be made before and after treatment in each individual patient, and between responders and non-responders. Attempts will be made to identify gene expression profiles that correlate with clinical outcome.|Up to 4 years|Due to lack of clinical efficacy and lack of drug supply, trial was closed early and gene expression profiles was not measured.|||||
837702|NCT01307618|Secondary|Overall Survival Assessed by Modified WHO Criteria|Median overall survival and the associated 95% confidence limits will be derived using the procedure described in Brookmeyer and Crowley.|Up to 4 years|||days||95% Confidence Interval|Median
837703|NCT01307618|Secondary|Progression-free Survival Assessed by Modified World Health Organization (WHO) Criteria|"Median progression-free survival and the associated 95% confidence limits will be derived using the procedure described in Brookmeyer and Crowley.
The criteria for progressive disease are 1) appearance of new lesions, 2) 25% increase in the sum of the product of the largest perpendicular diameters of the indicator lesions, or 3) reappearance of any tumor."|Up to 4 years|||days||95% Confidence Interval|Median
837704|NCT01307618|Primary|Type and Grade of Toxicity Incidents Assessed by Common Toxicity Criteria Version 4.0 (CTCAE v4.0)||Up to 4 years|Patients who experienced any adverse event were counted.||participants|||Number
837707|NCT01307631|Other Pre-specified|Incidence of Adverse Events as Assessed by NCI CTCAE Version 4.0 [Time Frame: Up to 3 Years] [Designated as Safety Issue: Yes]|Data is reported in the Adverse Event table.|3 years||||||
837708|NCT01307631|Other Pre-specified|Association Between Select Biomarkers and Response to Akt Inhibitor MK2206 Such as Progression-free Survival and Objective Tumor Response, Assessed by Immunohistochemistry (IHC)||Up to 3 years||||||
837711|NCT01307631|Primary|Progression-free Survival According to RECIST|Activity will be ascertained by the proportion of patients who survive progression-free for at least 6 months after initiating therapy or who have objective tumor response. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to < 10 mm; Partial Response (PR), at least 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|From start of treatment to time of objective disease progression, assessed up to 6 months|Number of patients who had a PFS > 6 months.||Participants|||Count of Participants
837712|NCT01307631|Primary|Objective Tumor Response According to RECIST|Activity will be ascertained by the proportion of patients who survive progression-free for at least 6 months after initiating therapy or who have objective tumor response. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to < 10 mm; Partial Response (PR), at least 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Up to 6 months|Number of patients who had an objective response.||Participants|||Count of Participants
837713|NCT01307787|Secondary|Change in Health Status: Social Interaction|Self-reported health status was assessed using the Arthritis Impact-Measurement Scale-2, the Dutch version (Dutch-AIMS2).The questionnaire contains 77 items which represent 5 dimensions: physical functioning, psychological functioning, symptoms, social interaction and role functioning. Responses are recorded on a 5-point scale. All responses were recoded and calculated to a 0-10 scale. Scores were modified according to the number of co-morbidity complaints, as was recommended in the Dutch-AIMS2 manual. A low score indicates better health.|baseline, postintervention at 9 weeks,|per protocol,2 subjects( n=2) in the intervention fitprogram withdrew from the study.||units on a scale||Standard Deviation|Mean
837714|NCT01307787|Secondary|Change in Health Status: Psychological Health|Self-reported health status was assessed using the Arthritis Impact-Measurement Scale-2, the Dutch version (Dutch-AIMS2).The questionnaire contains 77 items which represent 5 dimensions: physical functioning, psychological functioning, symptoms, social interaction and role functioning. Responses are recorded on a 5-point scale. All responses were recoded and calculated to a 0-10 scale. Scores were modified according to the number of co-morbidity complaints, as was recommended in the Dutch-AIMS2 manual. A low score indicates better health.|baseline, postintervention at 9 weeks,|analysis per protocol,2 subjects( n=2) in the intervention fitprogram withdrew from the study.||units on a scale||Standard Deviation|Mean
837715|NCT01307787|Secondary|Change in Health Status: Physical Health|Self-reported health status was assessed using the Arthritis Impact-Measurement Scale-2, the Dutch version (Dutch-AIMS2).The questionnaire contains 77 items which represent 5 dimensions: physical functioning, psychological functioning, symptoms, social interaction and role functioning. Responses are recorded on a 5-point scale. All responses were recoded and calculated to a 0-10 scale. Scores were modified according to the number of co-morbidity complaints, as was recommended in the Dutch-AIMS2 manual. A low score indicates better health.|baseline, postintervention at 9 weeks,|per protocol,2 subjects( n=2) in the intervention fitprogram withdrew from the study.||units on a scale||Standard Deviation|Mean
837716|NCT01307787|Secondary|Change in Muscle Strength of the Lower Extremity|Muscle strength was assessed using a hand-held dynamometer (Microfet, Hoggan health Industries Inc.USA).Maximal voluntary isometric muscle strength of the knee-flexor and knee-extensors, was tested and recorded three times for each muscle group. All tests were performed bilaterally. The mean value of three measurements was computed. In addition a sum score of the mean values of the flexors and extensors on both sides for the lower extremity (LE)was computed and taken for analyses.|baseline, postintervention at 9 weeks,|per protocol,Lower extremity(LE) muscle strength data for one participant(n=1) in the WLC group is missing because knee problems prevented testing.||newton||Standard Deviation|Mean
837717|NCT01307787|Secondary|Change in Muscle Strength of the Upper Extremity|Muscle strength was assessed using a hand-held dynamometer (Microfet, Hoggan health Industries Inc.USA).Maximal voluntary isometric muscle strength of the elbow-flexors, elbow-extensors, was tested and recorded three times for each muscle group. All tests were performed bilaterally. The mean value of three measurements was computed. In addition a sum score of the mean values of the flexors and extensors on both sides for the upper extremity (UE)was computed and taken for analyses.|baseline, postintervention at 9 weeks,|per protocol, one subject (n=1) in the intervention fitprogram withdrew from the study.||newton||Standard Deviation|Mean
837718|NCT01307787|Secondary|Change in Self-efficacy Function|Self-efficacy function was assessed by the Arthritis-Self-efficacy Scale Dutch version The subscale self-efficacy function contains 8 items related to physical function. A five-point ordinal scale is used ranging from ‘totally disagree’ (1) to ‘totally agree’ (5). A mean score of 8 items was computed ranging from 1-5. A higher score refers to higher self-efficacy.|baseline, postintervention at 9 weeks,|analysis per protocol, 2 subjects(n=2) in the intervention fitprogram withdrew from the study.||units on a scale||Standard Deviation|Mean
837719|NCT01307787|Secondary|Change in Self-efficacy Pain and Other Symptoms|Self-efficacy was assessed by the Arthritis-Self-efficacy Scale Dutch version. This arthritis self-efficacy scale contains two sub scales: self-efficacy pain (5 items related to coping with pain, and self-efficacy other symptoms (6 items related to coping with other symptoms, such as depression, fatigue and frustrations.A five-point ordinal scale is used ranging from ‘totally disagree’ (1) to ‘totally agree’ (5). We computed a mean score of 11 items ranging from 1-5. A higher score refers to higher self-efficacy.|baseline, postintervention at 9 weeks,|per protocol 2 subjects( n=2) in the intervention fitprogram withdrew from the study||units on a scale||Standard Deviation|Mean
837736|NCT01308476|Secondary|Change From Baseline in Adherence to Spiriva HandiHaler Over Time|Adherence was defined as percentage of documented applications of Spiriva HandiHaler as compared to the regularly planned seven applications during the week before questioning the patients. Patients in the SMS reminder group and in the control group were asked via SMS how often they had used Spiriva HandiHaler during the last week and were requested to call the IVR system to provide their response. Baseline was defined as week 4.|Week 8, Week 12, Week 16, Week 20 and Week 24|FAS. Only subjects who responded to the SMS/ IVR system were considered in this analysis.||Percent change||Standard Deviation|Mean
837720|NCT01307787|Primary|Change in VO2 Max, Maximum Oxygen Uptake in ml/Min/kg is the Standard Index of Cardio-respiratory Fitness|maximum oxygen uptake(VO2max, in ml/min/kg)was determined using the Åstrand-Rhyming test.The workload on the cycle ergometer was increased every minute by 25 watts until a steady-state heart rate was achieved. Participants had to sustain cycling for about 6 minutes, the heart rate(HR) was taken every minute. Mean HR of the 5th and 6th minute was registered. With the given workload, observed HR and participants’weight, maximal oxygen uptake can be established using the Åstrand-Rhyming nomogram. Values vary from < 21( sedentary with disease) to > 57 ( very good physical condition).|baseline, postintervention at 9 weeks|Some VO2 max data (n=4 in the intervention group and n=2 in the WLC group)could not be collected because of specific participant conditions at different testing time points. 4 subjects did not reach the necessary heart rate to estimate the VO2 max. One subject had hypertension and one subject had knee problems.||ml/min/kg||Standard Deviation|Mean
837724|NCT01308424|Primary|Proportion of Subjects Who Experience a New Cold Sore Outbreak That Proceeds to the Lesion Stage. Of Those Subjects That Take Study Medication (Experience a New Emerging Cold Sore) Those That Proceed to Lesion Stage (Cold Sore Stage - 3 Vesicle or Above).|Subjects start a daily diary based on start of symptoms of a new emerging cold sore and start taking study medication. Subjects note the start time of study medication along with cold sore stage(s)for at least 7 days and up to 14 days. Subjects take study medication for 7 days. Cold Sore stages are 0=Dormant, 1=Prodrome, 2=Inflammation, 3=Vesicle, 4=Ulcer, 5=Crust, 6=Healed. If subjects do not experience a new cold sore outbreak within 7 days, they do not take study medication and are completed with the study.|7-14 days (depending on time of lesion outbreak - subjects had 7 days to experience a new emerging cold sore)|As randomized subjects waited until reoccurrence of cold sore lesions, 23/87 participants in the placebo treatment group and 9/84 in the BTL-TML-HSV group took study medication and were eligible for the primary outcome.||percentage of Participants|||Number
837725|NCT01308450|Primary|Well-screened, Non-ADHD Controls to Augment the Existing Adolescent and Adult Database Thus Expanding the Normative Reference Range of Performance of the Quotient® Adolescent and Adult Version Test.|"To increase the number of normal Adolescent and Adult tests to the existing Quotient System Database. To assure subjects are normal, participants will complete a standard battery of self assessment questionnaires to screen for the presence of mental health issues including: ADHD, Anxiety Disorder, Depressive Disorder or Bipolar Disorder using the following well established scales and their scoring guidelines:
ADHD Self Rating Scale (ASRS)
Zung Self-Rated Anxiety Scale (SAS)
Zung Self-Rated Depression Scale (SDS)
Mood Disorder Questionnaire (MDQ)
Quotient® ADHD System Test, Adolescent and version Each subject and their individual assessment scores will be evaluated by a physician. Those participants evaluated as normal(without ADHD) will have the results of their Quotient test added to the existing Quotient normative database of Non ADHD subjects."|12 to 18 weeks|||participants|||Number
837726|NCT01308463|Secondary|Survivorship Will be Measured by the Incidence of Revision or Removals|The consented Patient will answer specific questions about their elbow replacement such as; if the elbow replacement has been removed|10 years Post-op|This analysis cannot be conducted due to the low number of cases available with 10 year data. There is not sufficient data to calculate survivorship. This study is being terminated since the product has been sold to another company.|||Elbows||
837727|NCT01308463|Primary|Patient Derived American Shoulder and Elbow Society (ASES) Satisfaction|"This is the patient's perception of satisfaction with the elbow replacement surgery.
Maximum Score = 10 Minimum Score = 0 Maximum Score represents maximum satisfaction."|10 Years Post-op|The number of participants analyzed in this section is reflective of the number of participants/elbows with the complete data required to calculate this score. This is different than the number reflected in participant flow which is indicative of the number of participants/elbows with any data during the given interval.||units on a scale|Elbows|Standard Deviation|Mean
837728|NCT01308463|Primary|Patient Derived American Shoulder and Elbow Society (ASES) Function|This is the patient's perception of function. The maximum score is 36 and the minimum score is 0. The maximum score represents maximum function.|10 Years Post-op|The number of participants analyzed in this section is reflective of the number of participants/elbows with the complete data required to calculate this score. This is different than the number reflected in participant flow which is indicative of the number of participants/elbows with any data during the given interval.||units on a scale|Elbows|Standard Deviation|Mean
837729|NCT01308463|Primary|Patient Derived American Shoulder and Elbow Society (ASES) Pain Score|This is the patient's perception of pain related to the operative elbow. Maximum pain score = 50 (worst) Minimum pain score = 0 (best)|10 Years Post-op|The number of participants analyzed in this section is reflective of the number of participants/elbows with the complete data required to calculate this score. This is different than the number reflected in participant flow which is indicative of the number of participants/elbows with any data during the given interval.||units on a scale|Elbows|Standard Deviation|Median
837730|NCT01308476|Secondary|Patients Satisfaction With SMS System|Only patients in the SMS group were asked to assess their satisfaction with the SMS system by assigning German school grades 1=very good, 2=good, 3=satisfactory, 4=sufficient, 5=deficient, 6=insufficient.|Visit 2 (12 weeks) and visit 3 (24 weeks)|FAS for SMS reminder group only||Percantage of participants|||Number
837823|NCT01308788|Primary|2-year Change in OA PSV||Baseline and 24 month visits|one participant was unable to be measured for this outcome||cm/sec||Standard Error|Mean
837737|NCT01308476|Primary|Adherence to Spiriva HandiHaler Over Time|Adherence was defined as percentage of documented applications of Spiriva HandiHaler as compared to the regularly planned seven applications during the week before questioning the patients. Patients in the SMS reminder group and in the control group were asked via SMS how often they had used Spiriva HandiHaler during the last week and were requested to call the IVR system to provide their response. Baseline was defined as week 4.|Baseline, Week 8, Week 12, Week 16, Week 20 and Week 24|"Full Analysis Set (FAS) is defined as all treated patients who additionally met the study diagnosis (Chronic Obstructive Pulmonary Disease (COPD) requiring long-acting anticholinergics) and who had evaluable data in at least one effectiveness endpoint.
Only subjects who responded to the SMS/ IVR system were considered in this analysis."||Percentage of applications||Standard Deviation|Mean
837824|NCT01308788|Primary|6-month Change in Ocular Perfusion Pressures (OPP)||Baseline and 6 month visits|||mm Hg||Standard Error|Mean
837825|NCT01308788|Primary|6-month Change in Central Retinal Artery (CRA) Vascular Resistance (RI)||Baseline and 6 month visits|||unitless||Standard Error|Mean
837826|NCT01308788|Primary|6-month Change in Central Retinal Artery (CRA) End Diastolic Velocity (EDV)||Baseline and 6 month visits|||cm/sec||Standard Error|Mean
837749|NCT01308580|Secondary|Plasma Steady State Volume of Distribution (Vss) for Cabazitaxel|Blood samples for PK analysis were obtained from a subset of the study participants (approximately 150 participants/group, by protocol) according to a sparse sampling strategy.|Day 1 of Cycle 1: 5 minutes before the EOI, 15 minutes, 1 to 4 hour, 6 to 24 hours, 48 to 168 hour after EOI|Analysis was performed on PK population. Number of participants analyzed= participants with PK assessment at specified time-points.||litre||Standard Deviation|Mean
837750|NCT01308580|Secondary|Plasma Clearance (CL) for Cabazitaxel|Blood samples for pharmacokinetic (PK) analysis were obtained from a subset of the study participants (approximately 150 participants/group, by protocol) according to a sparse sampling strategy.|Day 1 of Cycle 1: 5 minutes before the end of infusion (EOI), 15 minutes, 1 to 4 hour, 6 to 24 hours, 48 to 168 hour after EOI|Analysis was performed on PK population that included participants who had evaluable PK data. Number of participants analyzed= participants with PK assessment at specified time-points.||Litre/hour||Standard Deviation|Mean
837751|NCT01308580|Secondary|Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)|Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an adverse event (AE) without regard to possibility of causal relationship with this treatment. TEAEs: AEs that developed or worsened or became serious during on-treatment period. On-treatment period: The time from the first dose of treatment to 30 days after the last dose of treatment (either Cabazitaxel or Prednisone). A serious adverse event: Any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs. National Cancer Institute Common Terminology Criteria (NCI-CTCAE) version 4.03 (Grade 3 [severe] and Grade 4 [life-threatening]) was used in this study to grade clinical AEs.|From first administration of study treatment until 30 days after the last administration of study treatment (Maximum duration: 48 months)|Safety population included all randomized participants who received at least one dose of the study drug during study treatment period.||percentage of participants|||Number
837752|NCT01308580|Secondary|Time to First Definitive Consumption of Narcotic Medication|Concomitant medications used were recorded for all participants, and time of first definitive consumption of narcotic medication (if it occurred) was determined. This measure summarizes the time from baseline to first definitive consumption of narcotic medication. Analysis was performed by Kaplan-Meier method.|From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months)|Analysis was performed on ITT population.||months||95% Confidence Interval|Median
837753|NCT01308580|Secondary|Time to Definitive Weight Loss by 5% and 10% From Baseline|Time to definitive weight loss was defined as the time to first occurrence of ≥5% or ≥10% decrease in body weight from baseline. Analysis was performed by Kaplan-Meier method.|From baseline until death or study cut-off date (maximum duration: 48 months)|Analysis was performed on ITT population.||months||95% Confidence Interval|Median
837754|NCT01308580|Secondary|Time to Definitive Deterioration of ECOG PS Score From Baseline|The ECOG PS was used to evaluate participant’s DP and the effect of the disease on the participant’s activities of daily living. It ranges on the scale from 0-5 (0= normal activity; 1= symptoms but ambulatory; 2= in bed for < 50 % of the time; 3= in bed for > 50% of the time; 4= 100% bedridden; 5= dead). Time to definitive deterioration in ECOG PS score from baseline was defined as a change from 0, 1 to ≥2, or from 2 to ≥3. Analysis was performed by Kaplan-Meier method.|From baseline until death or study cut-off date (maximum duration: 48 months)|Analysis was performed on ITT population.||months||95% Confidence Interval|Median
837755|NCT01308580|Secondary|Time to Definitive Deterioration of Score by 10% From Baseline on FACT-P Sub-Scales|The time to definitive deterioration (10% decrease in score from baseline) was assessed for the individual sub-scales (Physical Well-Being; Social/Family Well-Being; Emotional Well-Being; Functional Well-Being; Prostate-Specific Concerns). Analysis was performed by Kaplan-Meier method.|From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months)|Analysis was performed on FACT-P population.||months||95% Confidence Interval|Median
837756|NCT01308580|Secondary|Percentage of Participants With FACT-P Total Score Response|FACT-P is a 39-item participant questionnaire that measures the concerns of participants with prostate cancer. It consists of 5 sub-scales assessing physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and prostate-specific concerns (12 items). FACT-P Total Score sums all 5 sub-scales to give a score in the range of 0 to 156, where higher values represent better HRQoL. Responder of FACT-P was defined as at least one occurrence of 7-point improvement from baseline in FACT-P total score during treatment period.|From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months)|Analysis was performed on FACT-P population. Number of participants analyzed= participants with evaluable FACT-P total score for specified outcome measure.||percentage of participants||95% Confidence Interval|Number
837757|NCT01308580|Secondary|Change From Baseline in FACT-P:Total Score as a Measure of HRQoL|FACT-P is a 39-item participant questionnaire that measures the concerns of participants with prostate cancer. It consists of 5 sub-scales assessing physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and prostate-specific concerns (12 items). FACT-P Total Score sums all 5 sub-scales to give a score in the range of 0 to 156, where higher values represent better HRQoL.|Baseline, Day 1 of each Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 (each cycle 21-day); post-treatment follow up 1 (up to 12 weeks)|Analysis was performed on FACT-P population. Number of participants analyzed=participants with evaluable FACT-P Total Score for specified outcome measure. Here, ‘n’ signifies number of participants with available data for specified category.||units on a scale||95% Confidence Interval|Least Squares Mean
837758|NCT01308580|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P):Trial Outcome Index (TOI) as a Measure of Health Related Quality of Life (HRQoL)|FACT-P is a 39-item participant questionnaire that measures the concerns of participants with prostate cancer. It consists of 5 sub-scales assessing physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and prostate-specific concerns (12 items). FACT-P TOI combines physical well-being, functional well-being, and prostate-specific concerns sub-scales for a total possible score range of 0 to 104, where higher values represent better HRQoL.|Baseline, Day 1 of each Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 (each cycle 21-day); post-treatment follow up 1 (up to 12 weeks)|FACT-P population included randomized participants who completed FACT-P questionnaire at baseline & in at least one post-baseline assessment. Number of participants analyzed=participants with evaluable FACT-P TOI for specified outcome measure. Here, ‘n’ signifies number of participants with available data for specified category.||units on a scale||95% Confidence Interval|Least Squares Mean
837759|NCT01308580|Secondary|Percentage of Participants With Pain Response|Pain response was defined as either a ≥2-point decrease from baseline median PPI score without increase in AS, or a ≥50% decrease from baseline mean AS without increase in the PPI score, maintained for 2 consecutive evaluations at least 3 weeks apart. Increases in pain during the first 12 weeks were ignored in determining pain response.|From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months)|Analysis was performed on ITT population. Number of participants analyzed= participants evaluable for pain response with pain score with median PPI ≥2 and/or mean AS ≥10 points at baseline and at least one valid post-baseline value.||percentage of participants||95% Confidence Interval|Number
837760|NCT01308580|Secondary|Time to Pain Progression|Pain Progression was defined as an increase of ≥1 point in the median PPI from its nadir confirmed by a second assessment at least 3 weeks later or ≥25 % increase in the mean AS compared with the baseline score confirmed by a second assessment at least 3 weeks later or requirement for local palliative radiotherapy. PPI was rated by participant in a diary using a scale of 0=no pain, 1=mild, 2=discomforting, 3=distressing, 4=horrible 5=excruciating. Analgesic use was recorded by the participant in a diary. AS was calculated from the analgesic use data based on a table of analgesic medications, with non-narcotic medications assigned a value of 1 point and narcotic medications assigned a value of 4 points. Analysis was performed by Kaplan-Meier method.|From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months)|Analysis was performed on ITT population.||months||95% Confidence Interval|Median
837761|NCT01308580|Secondary|Percentage of Participants With PSA Response|PSA response was defined as ≥50% decrease from baseline in serum PSA levels, confirmed by a second PSA value at least 3 weeks later in participants with baseline PSA value ≥10 ng/mL.|From baseline up to PSA progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months)|Analysis was performed on ITT population. Number of participants analyzed= participants evaluable for PSA response with PSA value ≥10 ng/mL at baseline and at least one valid post-baseline value.||percentage of participants||95% Confidence Interval|Number
837827|NCT01308788|Primary|6-month Change in Central Retinal Artery (CRA) Peak Systolic Velocity (PSV)||Baseline and 6 month visits|||cm/sec||Standard Error|Mean
837828|NCT01308788|Primary|6-month Change in Phthalmic Artery (OA) Vascular Resistance (RI)||Baseline and 6 month visits|||unitless||Standard Error|Mean
837829|NCT01308788|Primary|6-month Change in Phthalmic Artery (OA) End Diastolic Velocity (EDV)||Baseline and 6 month visits|||cm/sec||Standard Error|Mean
837830|NCT01308788|Primary|6-month Change in Ophthalmic Artery (OA) Peak Systolic Velocity (PSV)||Baseline and 6 month visits|||cm/sec||Standard Error|Mean
837762|NCT01308580|Secondary|Time to PSA Progression|Time to PSA progression was time interval between randomization & first occurrence of PSA progression. PSA progression defined as: 1) PSA responders (>50% decline from baseline PSA ≥10 ng/mL): increase of ≥25% (≥2 ng/mL) over nadir value, confirmed by second PSA ≥3 weeks later; 2) PSA non-responders (did not achieve >50% decline from baseline PSA ≥10 ng/mL): increase of ≥25% (≥2 ng/mL) over baseline value, confirmed by second PSA ≥3 weeks later; 3) In participants not eligible for PSA response (baseline PSA <10 ng/mL): (a) participants with baseline PSA >0 ng/mL & <10 ng/mL: increase in PSA by 25% (≥2 ng/mL) above baseline level, confirmed by second PSA value ≥3 weeks apart; (b) participants with baseline value=0 ng/mL: post-baseline PSA value ≥2 ng/mL. Note (for 1-3): Rise in PSA in first 12 weeks was progression only if met definition above and was associated with other sign of DP or if it continued beyond 12 weeks. Analysis was performed by Kaplan-Meier method.|From baseline up to PSA progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months)|Analysis was performed on ITT population.||months||95% Confidence Interval|Median
837763|NCT01308580|Secondary|Percentage of Participants With Overall Objective Tumor Response|Overall objective tumor response was defined as either a partial response (PR) or complete response (CR) according to the RECIST 1.1 criteria, as assessed by the investigator. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must had reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|From baseline up to DP or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months)|Analysis was performed on ITT population. Number of participants analyzed= participants evaluable for tumor response with measurable disease at baseline and at least one valid post-baseline value.||percentage of participants||95% Confidence Interval|Number
837764|NCT01308580|Secondary|Time to Tumor Progression|Time to Tumor progression was defined as the first occurrence of radiological tumor progression according to RECIST 1.1. Radiological tumor progression was defined at least a 20% increase in sum of diameters of target lesions (sum must also demonstrate an absolute increase of ≥5 mm) taking as reference the smallest sum while on study, appearance of one or more new lesions, or unequivocal progression of existing non target-lesions. Analysis was performed by Kaplan-Meier method.|From baseline up to tumor progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months)|Analysis was performed on ITT population.||months||95% Confidence Interval|Median
837765|NCT01308580|Secondary|Progression Free Survival (PFS)|PFS was evaluated from date of randomization to date of first documentation of any of the events: 1) Radiological tumor progression: as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1: at least a 20% increase in sum of diameters of target lesions (sum must also demonstrate an absolute increase of ≥5 mm) taking as reference the smallest sum while on study, appearance of one or more new lesions, or unequivocal progression of existing non target lesions, 2) Prostate Specific Antigen (PSA) progression: ≥25% increase over baseline/nadir value if baseline PSA ≥10 ng/mL; or 25% increase above the baseline level if baseline PSA >0 ng/mL & <10 ng/mL; or post-baseline value of >=2 ng/mL, if baseline PSA=0 ng/mL, 3) Pain progression: increase of ≥1 point in median Present Pain Intensity (PPI) from nadir or ≥25% increase in mean analgesic score (AS) from baseline score or requirement of local palliative radiotherapy, 4) Death. Analysis was performed by Kaplan-Meier method.|From baseline up to tumor progression, PSA progression, pain progression, death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months)|Analysis was performed on ITT population.||months||95% Confidence Interval|Median
837766|NCT01308580|Primary|Overall Survival (OS)|OS was defined as the time interval from the date of randomization to the date of death due to any cause. In absence of confirmation of death, survival time was censored at the earlier of the last date the participant was known to be alive or the study cut-off date. The cut-off date for the final analysis of OS was the date when the 988th death had been observed. Analysis was performed by Kaplan-Meier method.|From baseline up to death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months)|Analysis was performed on Intent-to-Treat (ITT) population, which included all randomized participants.||months||95% Confidence Interval|Median
837767|NCT01308619|Secondary|Change From Baseline in Clinician's Erythema Assessment (CEA) Scores|Mean change in Clinician's Erythema Assessment (CEA) from baseline to week 12. Clinician's Erythema Assessment evaluates erythema on a scale from 0 - 4 (0 = None, 1 = Mild, 2 = Moderate, 3 = Significant and 4 = Severe) with 0 being best and 4 being worst.|baseline to week 12|||units on a scale||Standard Deviation|Mean
837768|NCT01308619|Secondary|Investigator's Global Assessment (IGA) Scores at Week 12|Number of participants in each category of the Investigator's Global Assessment (IGA) scores at week 12. Investigator's Global Assessment evaluates papules and pustules of rosacea on a scale from 0 - 4 (0 = Clear, 1 = Near Clear, 2 = Mild, 3 = Moderate and 4 = Severe) with 0 being best and 4 being worst.|Week 12|||participants|||Number
837769|NCT01308619|Secondary|Change From Baseline in Biochemical Markers of Rosacea From Tape Stripping and/or Skin Biopsy From Baseline to Week 12|Mean change from baseline to week 12 in biochemical markers of rosacea and expression in skin samples. A biological marker is a substance used as an indicator of a biological state such as rosacea. Biochemical markers are serine protease activity and expression, metalloprotease activity and expression, and production of leucine leucine-37 [LL-37] peptide.|baseline to week 12|Treatment success was defined as all subjects from either treatment group with a score of clear or near clear on the Investigator’s Global Assessment (IGA) scale. Treatment failure was defined as all subjects from either treatment group with a score of mild, moderate, or severe on the IGA scale.||micr grams protein||Standard Deviation|Mean
837770|NCT01308619|Primary|Change From Baseline in Inflammatory Lesion Counts|Mean change in inflammatory lesion counts from baseline to week 12|baseline to week 12|||inflammatory lesions||Standard Deviation|Mean
837771|NCT01296763|Secondary|Number of Years From Cycle 1, Day 1 On-Study to Date of Death|The overall survival of subjects with locally advanced and/or metastatic pancreatic cancer treated with Irinotecan, Cisplatin, Olaparib, with escalation to the addition of Mitomycin-C. Survival from cycle 1, day 1 on-study to date of death was assessed.|5 years|||years (survival) from C1D1 to death||Full Range|Mean
837843|NCT01308918|Secondary|Correlation Between the Difficult Intubation Score and a Successful Intubation||1 hour (Post intubation)||||||
837844|NCT01308918|Secondary|Number of Attempt to Obtain a Successful Intubation||1 hour (Post intubation)|||Attempts|||Number
837772|NCT01296763|Primary|Number of Participants Who Experienced a Dose Limiting Toxicity to Determine the Maximum Tolerated Dose (MTD)|"1.Phase I - Assess the safety and toxicities of IC with Olaparib escalating to ICM with Olaparib in patients with locally advanced and metastatic pancreatic cancer and determine the phase 2 dose. The number of subjects who experienced a dose limiting toxicity was assessed.Dose-limiting toxicity (DLT) is defined as any of the following study drug-related events experienced during Cycle 1:
Thrombocytopenia with platelets <25,000 x106/l > 7 days. Grade 4 neutropenia lasting ≥7 days. Grade 3 or 4 febrile neutropenia. Grade 3 or greater non-haematological toxicities; excluding grade 3 diarrhoea, nausea or vomiting despite adequate treatment and grade 3 fatigue, lethargy and GGT elevation.
Delay of >2 weeks for next scheduled IC/ICM for reasons of toxicity."|2 years|Number of subjects who experienced a dose limiting toxicity, as defined in the protocol.||participants|||Number
837773|NCT01296815|Secondary|Safety|Adverse events will be assessed according to the Council for International Organizations of Medical Sciences (CIOMS) I Working Group the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events.|12 months||||||
837774|NCT01296815|Primary|Number of Participants With Complete Response|Complete response will be assessed according to RECIST criteria|12 months|||participants|||Number
837775|NCT01296841|Secondary|Clinic Appointment Wait Time|The investigators recorded clinic appointment wait time duration in minutes|Clinic Visit|||minutes||Standard Deviation|Mean
837776|NCT01296841|Secondary|Clinic Appointment Duration|The investigators recorded appointment duration in minutes.|Clinic Visit|Pilot.||Minutes||Standard Deviation|Mean
837777|NCT01296841|Primary|Patient Clinical Experience|We used a validated Ware Specific Visit Questionnaire to assess patients’ satisfaction with their clinic-visit encounter. This is a 14-item questionnaire on doctor–patient interaction including factors such as attention to complaints, technical skills, and personal manner (courtesy,and ease of appointment scheduling and is based on a five-point Likert scale (1 excellent to 5 poor). Patients completed the questionnaire at the time of the visit. The 14 item scores were individually scored and then averaged to provide the final overall value.|Clinic Visit|per protocol||units on a scale||Standard Deviation|Mean
837778|NCT01302392|Secondary|Duration of Disease Control|Duration of Disease Control was calculated for subjects who achieved disease control. Duration of Disease Control was defined as the time in months from randomization to the earlier of documented progressive disease (PD) or death due to any cause. Participants who had not progressed or died were censored according to the censoring rules defined previously for progression-free survival.|From time of achieving disease control through the final analysis data cutoff with longest follow-up time of approximately 31 months.|The intent to treat (ITT) population comprised randomized participants who achieved disease control.||months||95% Confidence Interval|Median
837779|NCT01302392|Secondary|Disease Control|Number of participants who achieved confirmed stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), minimal response (MR), or stable disease (SD) lasting ≥ 8 weeks as their best response. Response was determined using the International Myeloma Working Group - Uniform Response Criteria (IMWG-URC). (MR was determined using European Group for Blood and Marrow Transplantation criteria)|From randomization through the final analysis data cutoff with longest follow-up time of approximately 31 months. Median follow up times were 26.6 months and 23.1 months for Carfilzomib and Best Supportive Care groups, respectively.|The intent to treat (ITT) analysis set comprised all randomized participants.||participants|||Number
837780|NCT01302392|Secondary|Duration of Clinical Benefit|Duration of Clinical Benefit was calculated for subjects who achieved a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR) or minimal response (MR). Duration of Clinical Benefit was defined as the time in months from the initial start of response (MR or better) to the earlier of documented progressive disease (PD) or death due to any cause. Participants who had not progressed or died were censored according to the censoring rules defined previously for progression-free survival.|From time of achieving clinical benefit through the final analysis data cutoff with longest follow-up time of approximately 30 months.|The intent to treat (ITT) population comprised randomized participants who achieved a best overall response of MR or better only.||months||95% Confidence Interval|Median
837781|NCT01302392|Secondary|Clinical Benefit Response|Number of participants who achieved confirmed stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), or minimal response (MR) as their best response. Response was determined using the International Myeloma Working Group - Uniform Response Criteria (IMWG-URC). (MR was determined using European Group for Blood and Marrow Transplantation criteria)|From randomization through the final analysis data cutoff with longest follow-up time of approximately 31 months. Median follow up times were 26.6 months and 23.1 months for Carfilzomib and Best Supportive Care groups, respectively.|The intent to treat (ITT) analysis set comprised all randomized participants.||participants|||Number
837782|NCT01302392|Secondary|Duration of Response|Duration of response (DOR) was calculated for subjects who achieved a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR). Duration of response was defined as the time in months from the initial start of response (PR or better) to the earlier of documented progressive disease (PD) or death due to any cause. Participants who had not progressed or died were censored according to the censoring rules defined previously for progression-free survival.|From the time achieving response through the final analysis data cutoff with longest follow-up time of approximately 29 months.|The intent to treat (ITT) population comprised randomized participants who achieved a best overall response of PR or better only.||months||95% Confidence Interval|Median
837783|NCT01302392|Secondary|Overall Response|Number of participants who achieved confirmed stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) as their best response. Response was determined using the International Myeloma Working Group - Uniform Response Criteria (IMWG-URC).|From randomization through the final analysis data cutoff with longest follow-up time of approximately 31 months. Median follow up times were 26.6 months and 23.1 months for Carfilzomib and Best Supportive Care groups, respectively.|The intent to treat (ITT) analysis set comprised all randomized participants.||participants|||Number
838091|NCT01311661|Secondary|Mean Pre-dose Evening FEV1 (FEV1 p.m.)|FEV1 p.m. was measured by patients at home using the AM3 device (overall means obtained during each period of randomised treatment will be compared). Means are adjusted for treatment, period, patient and study baseline.|0-3 weeks|FAS||mL||Standard Error|Mean
837784|NCT01302392|Secondary|Progression-free Survival|Kaplan-Meier estimate of median time from randomization to progressive disease (PD) or all-cause death. PD was assessed using International Myeloma Working Group-Uniform Response Criteria (IMWG-URC). 1 or more conditions were required to meet PD: 2 consecutive rising serum or urine M-protein from central lab; documented new bone lesion(s) or soft tissue plasmacytoma(s) or increased size of existing bone lesion(s) or plasmacytoma(s); or confirmed hypercalcemia due solely to plasma cell proliferative disorder (local lab greater than 11.5 mg/dL on 2 separate occasions). Censoring conditions (censoring dates) were: no post-baseline disease assessment (DA) (randomization date); started non-protocol systemic anticancer treatment before PD or death (last DA date before such treatment); died or had PD after more than 1 missed DA (last DA date without PD before the first missed visit); or were alive and without documentation of PD, including lost to follow-up without PD (last DA date).|From randomization through the final analysis data cutoff with longest follow-up time of approximately 31 months. Median follow up times were 26.6 months and 23.1 months for Carfilzomib and Best Supportive Care groups, respectively.|The intent to treat (ITT) analysis set comprised all randomized participants.||months||95% Confidence Interval|Median
837785|NCT01302392|Primary|Overall Survival|Time elapsed between the randomization date and the date of death. Participants who were still alive were censored at date when the subject is last known alive or the data cutoff date, whichever occurs earlier.|From randomization through the final analysis data cutoff with longest follow-up time of approximately 45 months. Median follow up times were 27.8 months and 29.8 months for Carfilzomib and Best Supportive Care groups, respectively.|The intent to treat (ITT) analysis set comprised all randomized participants.||months||95% Confidence Interval|Median
837786|NCT01302418|Primary|Detection of Respiratory Viruses|The presence of Influenza A or Influenza B virus.|Specimens will be taken within 5 days of the appearance of symptoms.|All subjects meeting inclusion/ exclusion criteria and who had sufficient specimen volume.||participants|||Number
837787|NCT01302444|Secondary|Change From Baseline in Pulmonary Arterial Systolic Pressure (PASP)as Assessed by Transthoracic Echocardiography Using Doppler Ultrasound||16 weeks|data not reported for one participant for anonymity|||||
837788|NCT01302444|Secondary|Plasma BNP (Brain Natriuretic Peptide)Level Change||16 weeks of therapy|data not reported for one participant for anonymity|||||
837789|NCT01302444|Secondary|Tei Index Change by Transthoracic Echocardiography||16 weeks of therapy|data not reported for one participant for anonymity|||||
837790|NCT01302444|Secondary|6 Minute Walking Distance Change Will Improve||16 weeks of therapy|data not reported for one participant for anonymity|||||
837791|NCT01302444|Primary|Hospitalizations||16 weeks|data not reported for one participant for anonymity|||||
837792|NCT01302444|Primary|WHO Functional Class Will Improve or Remain Stable||16 weeks|data not reported for one participant for anonymity|||||
837793|NCT01302444|Primary|Adverse Events Are no Greater Than With Treprostinil Infusion Alone||16 weeks|data not reported for one participant for anonymity|||||
837794|NCT01302444|Primary|All Cause Mortality||16 weeks|data not reported for one participant for anonymity|||||
837795|NCT01302483|Secondary|Maximum Change in Pulse Oximetry From Baseline|Maximum change from Baseline at any time point|Baseline, 15, 20, 30, 40, 50, 60, 120 minutes|Intent to Treat||SpO2||Standard Deviation|Mean
837796|NCT01302483|Secondary|Maximum Change in Blood Pressure From Baseline|Maximum change from Baseline at any time point.|Baseline, 15, 20, 30, 40 50, 60, 120 minutes|Intention to treat||mmHG||Standard Deviation|Mean
837797|NCT01302483|Secondary|Maximum Change in Pulse From Baseline|Maximum change from Baseline at any time point.|Baseline, 15, 20, 30, 40, 50, 60, 120 minutes|Intention to treat||beats per minute||Standard Deviation|Mean
837798|NCT01302483|Secondary|Soft Tissue Anesthesia Duration|"Assessment of pain using a Rotadent sensor probe, applying up to 20 grams/cm^2 at the tissue site. At each time point, participants were asked if they felt pain from the sensor probe at each site location in the mouth. The four sites were:
Site 1: Distal to the apex of the tooth in the position of the maxillary first premolar at the deepest point in the buccal vestibule
Site 2: Apical to the maxillary lateral incisor at the deepest point in the labial vestibule
Site 3: Incisive papilla
Site 4: At the confluence of the alveolar process and hard palate medial to the maxillary second premolar (near the greater palatine foramen)"|Baseline, 15, 20, 30, 40, 50, 60, 80, 100, 120 minutes|Intention to treat||Minutes||Standard Deviation|Mean
837799|NCT01302483|Primary|Pulpal Anesthesia|Number of participants who did not need rescue anesthesia to complete the study dental procedure, i.e. Kovacaine provided enough pulpal anesthesia to complete a dental procedure.|Continuous throughout dental treatment period (up to 60 minutes)|Intention to treat||participants|||Number
837800|NCT01302548|Secondary|Abscess Measurement Using a Abscess Measurement Scale in Methicillin-resistant Staphylococcus Aureus (MRSA) Positive Patients.|"The Abscess Measurement Scale was measured using a centimeter ruler.
Scale 8cm – 10cm = Severe 6cm – 8cm = Moderate/severe 4cm – 6cm = Moderate 2cm – 4cm = Mild/moderate 0cm – 2cm = Mild"|48 hours|Only participants that were MRSA-positive, were analyzed.||units on a scale||Standard Deviation|Mean
837801|NCT01302548|Secondary|Number of Patients Prescribed Oral Antibiotics|Number of patients prescribed oral antibiotics|48 hours|||participants|||Number
837802|NCT01302548|Primary|Abscess Healing Based on Abscess Measurement Scale|"The abscess healing process will use two methods: 1) usual method includes saline irrigation and/or incision & drainage, and 2) the use of IRRISEPT solution. The Abscess Measurement Scale was measured using a centimeter ruler.
Scale 8cm – 10cm = Severe 6cm – 8cm = Moderate/severe 4cm – 6cm = Moderate 2cm – 4cm = Mild/moderate 0cm – 2cm = Mild"|48 hours|||units on a scale||Standard Deviation|Mean
837803|NCT01308736|Primary|Cigarette Reduction|50% reduction in cigarettes per day as compared to baseline. Missing data are assumed to NOT have reduced.|At 6-month follow-up|||participants|||Number
837804|NCT01308749|Secondary|Mean Change in Temperature During Period 1|Temperature was collected on each participant via oral or temporal thermometer. The mean change in each group was assessed.|Week 0 to 8|||degrees fahrenheit||Standard Error|Mean
837805|NCT01308749|Secondary|Mean Change in Prolactin Levels Over Period 1|Serum prolactin levels were collected and analyzed in participants|Week 0 to 8|||nanograms per milliliter (ng/mL)||Standard Error|Mean
837806|NCT01308749|Secondary|Change in Mean Systolic Blood Pressure During Period 1|Change in mean systolic blood pressure during double blind phase|Week 0 to 8|The one subject who discontinued at week 1 did not have follow up data to include in the analysis.||millimeters of mercury (mmHg)||Standard Error|Mean
837807|NCT01308749|Secondary|Change in Mean Pervasive Developmental Disorder Behavior Inventory - Screening Version (PDDBI-SV) Total Score Over Both Periods|The PDDBI-SV examines both adaptive and maladaptive behaviors related to autism. It has normative scores for children between 2-11 years. For children 12 years and older, the norms (11 years, 11 months) will be used. Each item is scored on a scale from 0-3. For the first 9 items, the total of individual items is summed. For items 10-18, the scores are reversed and then summed (i.e.: 0=3, 1 =2, 2=2, 3 = 0). Then the total of 0-9 and then the reversed scored items 10-18 are summed for a final total score. Higher scores indicate more impairment. The range of total scores is 0-54. ASD/Social deficits unlikely: 0-6, More information needed/borderline: 7-10, autism spectrum disorder (ASD)/social deficits likely (mild):11-14, ASD/social deficits likely (moderate): 15-29, ASD/social deficits likely (severe): 30-37, ASD/social deficits likely (extreme): 38 or higher.|Baseline to 16 Weeks|used only subjects with all data points no data carried forward||scores on a scale||Standard Error|Mean
837808|NCT01308749|Secondary|Change in Mean Aberrant Behavior Checklist (ABC)-Social Withdrawal Subscale Score Over Both Periods|Efficacy measures included the Aberrant Behavior Checklist -Social Withdrawal subscale scor. The ABC which focuses on problem behaviors in five subdomains, including irritability, attention, repetitive behaviors, unusual speech, and lethargy. A modified version of the lethargy subscale was used. Typically the Lethargy subscale includes 16 items, however, for our purposes 3 items that were specifically related to lethargy (i.e.: listlessness) were removed so that the focus could primarily be on aberrant social behavior. Differences in only the Social Withdrawal domain were assessed.The is the sum of items, each rated among 0 = Not at all; 1 = Slight in degree; 2 = Moderately serious; and 3 = Severe in degree. The ABC- Social Withdrawal total score ranges from 0 to 39. Higher values represent greater severity of illness.|Baseline to 16 Weeks|population of participants with all data available for mixed models analysis no data carried forward||scores on a scale||Standard Error|Mean
837809|NCT01308749|Secondary|Change in Mean Autism Diagnostic Observation Schedule (ADOS) Total Score|The ADOS is a semi-structured assessment used to assess and diagnose individuals suspected of having autism of varying ages, developmental levels, and language skills (from no speech to verbally fluent). The ADOS includes four modules, each requiring just 35-40 minutes to administer. The individual being evaluated is given just one of 4 modules, depending on his or her expressive language level and chronological age. The rater will observe social and communication behaviors during various activities in the appropriate module. A rater then uses a 0-3 scale to rate each type of behavior. A select number of individual items will be summed for a total score representing communication and reciprocal social interaction. In scoring all 3's are collapsed to a 2. A higher score indicates more severe impairment. Ranges of scores are as follows: Module 1: 0-24, Module 2: 0-24, Module 3: 0-22, Module 4: 0-22.|Baseline to 16 Weeks|1 patient without post baseline measures is not included||scores on a scale||Standard Error|Mean
837810|NCT01308749|Secondary|Change in Mean Total Social Social Responsiveness Scale (SRS) T-score|The 65-item SRS is a standardized measure of the core symptoms of autism. Each item is scored on a 4-point Likert scale. The raw score of each individual item is summed to create a total raw score. The total raw score is then translated into a total T-scores (which are the equivalent of standard scores). Total T-scores results are as follows: 59 and below: within normal limits, 60-65: Mild range of impairment 66-75: Moderate range of impairment 76 or higher: Severe range of impairment.|0-8 weeks, blinded treatment, period 1|All participants with at least one post baseline assessment, 1 person from sequence 1 discontinued due to no post baseline measures||T-scores||Standard Error|Mean
837811|NCT01308749|Secondary|Change in Mean Weight|changes during period 1|between weeks 0 and 8|The subject who discontinued after 2 days did not have repeat assessments and is excluded from these analyses||pounds||Standard Error|Mean
837812|NCT01308749|Secondary|Change in Mean Plasma Oxytocin Level During Period 1 - Double Blind Phase|Blood samples will be collected to obtain proof of concept data regarding changes in afternoon plasma oxytocin levels|Week 0 to week 8|participants with oxytocin plasma levels at baseline and week 8||picograms/mL (pg/mL)||Standard Deviation|Mean
837813|NCT01308749|Primary|Number of Participants Who Could Tolerate Twice Daily Oxytocin|This study will help to determine tolerability of intranasal oxytocin treatment in children with autism by measuring the ability of at least 80% of the sample to tolerate twice daily intranasal administration of oxytocin.|Week 0 to week 16|all participants who recieved oxytocin at any time||Participants|||Count of Participants
837814|NCT01308749|Primary|Number of Participants Who Could Tolerate Twice Daily Oxytocin|This study will help to determine tolerability of intranasal oxytocin treatment in children with autism by measuring the ability of at least 80% of the sample to tolerate twice daily intranasal administration of oxytocin.|Week 0 to week 8|This is over period 1, the double blind phase (week 0 to week 8) only||Participants|||Count of Participants
837815|NCT01308762|Secondary|Administration Site Reactions|Local skin reactions are viewed as a normal and predicted reaction to exposure to a preparation of mycobacterial antigens. All patients experienced administration site reactions and all reactions were examined and characterised. However only those reported as adverse events are presented here.|Day -3 to Day 56|Safety population||Participants|||Number
837816|NCT01308762|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|"Safety and tolerability were measured with respect to:
Safety measurements
Local tolerability at the site of intradermal injection
Incidence of adverse events."|56 days|All analyses were based on the safety population, which comprised of all patients who received at least one dose of IMP. Safety measurements and nature and incidence of adverse events were reported for the Safety population||Participants|||Number
837817|NCT01308788|Primary|2-year Change in OPP||Baseline and 24 month visits|||mm Hg||Standard Error|Mean
837818|NCT01308788|Primary|2-year Change in CRA RI||Baseline and 24 month visits|one participant was unable to be measured for this outcome||unitless||Standard Error|Mean
837819|NCT01308788|Primary|2-year Change in CRA EDV||Baseline and 24 month visits|one participant was unable to be measured for this outcome||cm/sec||Standard Error|Mean
837820|NCT01308788|Primary|2-year Change in CRA PSV||Baseline and 24 month visits|one participant was unable to be measured for this outcome||cm/sec||Standard Error|Mean
837821|NCT01308788|Primary|2-year Change in OA RI||Baseline and 24 month visits|one participant was unable to be measured for this outcome||unitless||Standard Error|Mean
837822|NCT01308788|Primary|2-year Change in OA EDV||Baseline and 24 month visits|one participant was unable to be measured for this outcome||cm/sec||Standard Error|Mean
837831|NCT01308814|Secondary|Change in Baroreceptor Sensitivity|"A finometer noninvasive blood pressure devise (FMS) was used to collect a 10 minute recording of beat-to-beat blood pressure and pulse rate during spontaneous breathing under quiet recumbent conditions. baroreflex sensitivity was computed from the most stable 5-minute segment of this 10-minute period. Cross-spectral analysis was used to estimate the average transfer function modulus (i.e., gain) between systemic blood pressure oscillations and R-R interval oscillations in the frequency range of 0.07-0.14 Hz, also known as the low frequency band. The units of this baroreflex sensitivity (BRS) were msec/mmHg.
The outcome presented here is the 12 month BRS minus baseline BRS."|Baseline, month 12|The data presented here are based on individuals who completed the study and provided useable data for this particular measure at the time point reported.||msec/mmHg||Standard Deviation|Mean
837832|NCT01308814|Secondary|Change in Percentage of Brachial Artery Diameter|Change (from Baseline-to-12 Month) in flow mediated dilatation (FMD) test of the brachial artery, dilatation occurs following an acute increase in blood flow, induced by via circulatory arrest in the arm for a period of time. Measured using high resolution ultrasound, yielding a measure of endothelial-dependent vasodilatation. The increase in brachial arterial diameter as a consequence of reactive hyperemia is compared to the baseline diameter of the artery and expressed as a percentage of the baseline diameter (% FMD). Flow-mediated vasodilatation at each time point was calculated as diameter of the brachial artery under reactive hyperemia minus baseline diameter of the brachial artery. The change presented here is calculated as 12 month %FMD minus baseline month %FMD.|Baseline, month 12|The data presented here are based on individuals who completed the study and provided useable data for this particular measure at the time point reported.||percent flow mediated dilatation||Standard Deviation|Mean
837833|NCT01308814|Secondary|Percentage Meeting Criteria for Metabolic Risk [Baseline and Month 12]|Subjects will be classified as having metabolic risk if they either meet standard criteria for the metabolic syndrome (based on 3 of 5 risk factors: elevated blood pressure, fasting triglycerides, fasting glucose, waist circumference and low HDL-cholesterol) or they exhibit insulin resistance based on the homeostatic model assessment (HOMA) to derive HOMA-IR based on fasting insulin and glucose levels using the equation: HOMA-IR = fasting glucose (mmol/L) × fasting insulin (μU/mL)/22.5|Baseline, month 12|The data presented here are based on individuals who completed the study and provided useable data for this particular measure at the time point reported.||Participants|||Count of Participants
837834|NCT01308814|Secondary|Change in Functional Well-being as Assessed by the Medical Outcomes Study 36-item Short Form (SF-36)|The Medical Outcomes Study 36-item Short Form (SF-36) is a measure of functional well-being, including physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to emotional health problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. The range of this scale is 0-100, where higher scores indicates a more favorable health state.|Baseline, month 12|The data presented here are based on individuals who completed the study and provided useable data for this particular measure at the time point reported.||units on a scale||Standard Deviation|Mean
837835|NCT01308814|Primary|Change in Stress Reactivity During Laboratory Session Including Trier Social Stress Test|Primary measures reflecting stress reactivity will consist of mean arterial pressure (MAP), vascular resistance index (VRI), plasma cortisol, and plasma IL-6. For each of these four measures, a delta score (change from rest to stress) will be calculated and then standardized as Z scores. The individual Z scores will then be averaged to yield a single Stress Reactivity profile measure (average z score) - a composite Z score reflecting magnitude of activation in the four primary stress-responsive pathways. This composite z score at baseline will be subtracted from the composite z score at 12 months to yield this outcome measure.|Baseline, month 12|The data presented here are based on individuals who completed the study and provided useable data for this particular measure at the time point reported.||composite Z score||Standard Deviation|Mean
837836|NCT01308814|Primary|Change in Psychiatric Diagnosis as Assessed by the Structured Clinical Interview for DSM Disorders I/NP||Baseline and when prompted by CES-D score|These data were not collected because this measure is no longer the preferred method for characterizing change in depression risk. The preferred method is now to measure depressive symptoms continuously, which was done. These continuous results can be found for the CESD score in this record.|||||
837837|NCT01308814|Primary|Change in Depressive Symptoms as Indicated by The Center for Epidemiologic Studies Depression Scale (CES-D)|Change from pre-trial (baseline) to post-trial (month 12) in the Center for Epidemiologic Studies Depression Scale (CES-D). The CES-D has a Range from 0-60, with higher scores indicating the presence of more symptomatology. A score of 16 or greater is indicative of clinically significant symptoms of depression.|Baseline, month 12|The data presented here are based on individuals who completed the study and provided useable data for this particular measure at the time point reported.||units on a scale||Standard Deviation|Mean
837838|NCT01308840|Secondary|The Number of Participants Who Experience an Adverse Event|Any adverse event continuing after the study completion and considered potentially related to study treatment will be followed until resolution, stabilization or initiation of treatment that confounds the ability to assess the event|baseline to study completion|||participants|||Number
837839|NCT01308840|Secondary|Median Overall Survival|Death from any cause was used.|enrollment until date of death|||months||Full Range|Median
837840|NCT01308840|Secondary|Median Progression Free Survival|Progression-free survival was defined as the time from study enrollment to date of cancer progression or death, whichever occurred first. Progression was assessed using CT scans and the Response Evaluation Criteria In Solid Tumors criteria. Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|time to cancer progression or death|||months||Full Range|Median
837841|NCT01308840|Primary|The Number of Participants With Response to GEMOX-Panitumumab (GEMOX-P) in Chemotherapy naïve KRAS/ BRAF Wild Type Stage IV Biliary Tract Cancer Using the Response Evaluation Criteria In Solid Tumors (RECIST) Criteria.|Tumor measurement - same imaging modality used in pre-treatment evaluation - include radiological examination of all areas with affected disease. For pretreatment and at the end of cycle 2 CT scans (chest/abdomen/pelvis) will be used. For all subsequent cycles, CT of chest/abdomen/pelvis will be used every 8 weeks.|end of cycle 2 of treatment|||participants|||Number
837842|NCT01308918|Secondary|Number of Complications Associated to the GlideRite DLT Stylet® Utilization|Complications defined either as oxygen desaturation below 95%, oxygen desaturation below 90%, minor bleeding, anatomic lesion.|1 hour (Post intubation)|||Participants|||Number
837845|NCT01308918|Secondary|Duration of the Intubating Process|The timer was started when the GLS blade was inserted between the lips and stopped when the proximal part of the tracheal cuff was passed through the vocal cords. When a patient had teeth at the superior jaw, the DLT was first inserted into the mouth prior to the insertion of the GLS blade in order to avoid rupturing the tracheal cuff. For these cases, the timer was started when the DLT was inserted between the lips.|1 hour (Post intubation)|||Seconds||Standard Deviation|Mean
837846|NCT01308918|Primary|Number of Successfull Primary Placement of the Double Lumen Tube.|To evaluate the number of participants where GlideRite DLT Stylet® associated to the video laryngoscopy (GlideScope®)allowed the primary placement of the double lumen tube into their trachea.|1 hour (Post intubation)|||Participants|||Number
837847|NCT01309581|Secondary|Quick Inventory of Depressive Symptomatology, Self Report (QIDS-SR)|The QIDS-SR is a 16-item self-rated instrument designed to assess the severity of depressive symptoms present in the past seven days (Rush et al 2003). The 16 items cover the nine symptom domains of major depression, and are rated on a scale of 0-3. Total score ranges from 0 to 27, with ranges of 0-5 (normal), 6-10 (mild), 11-15 (moderate), 16-20 (moderate to severe), and 21+ (severe).|Change from beginning of ECT treatment to end; on average 3 weeks||||||
837848|NCT01309581|Primary|Hamilton Rating Scale for Depression-24 (HRSD24)|"The HDRS-24 is used to rate depressive symptoms. This instrument is considered one of the gold standard clinician-rated instruments for depressive symptoms. We have established procedures for the maintenance of inter-rater reliability."|Change from beginning of ECT treatment to end; on average 3 weeks||||||
837849|NCT01309646|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs).|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Month 0 to Month 7)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.||subjects|||Number
837850|NCT01309646|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs).|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = any unsolicited AE regardless of intensity or relationship to vaccination.|During the 31-day (Days 0-30) follow-up period after any vaccination with Infanrix™-IPV+Hib or Infanrix™ IPV + Hiberix™|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.||subjects|||Number
837851|NCT01309646|Secondary|Number of Subjects With Any Solicited General Symptoms.|Assessed solicited general symptoms were drowsiness, irritability/fussiness, loss of appetite and fever [defined as tympanic temperature ≥ 37.5 degrees Celsius (°C)]. Any = incidence of a particular symptom regardless of intensity grade.|During the 4-day (Days 0-3) follow-up period after any vaccination with Infanrix™-IPV+Hib or Infanrix™ IPV + Hiberix™|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet completed.||subjects|||Number
837852|NCT01309646|Secondary|Number of Subjects With Any Solicited Local Symptoms.|Assessed solicited local symptoms were pain, redness and swelling at the injection site. Any = incidence of a particular symptom regardless of intensity grade.|During the 4-day (Days 0-3) follow-up period after any vaccination with Infanrix™-IPV+Hib or Infanrix™ IPV + Hiberix™|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet completed.||subjects|||Number
837853|NCT01309646|Secondary|Number of Subjects With a Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN.|Vaccine response was defined as antibody concentration ≥ 5 EL.U/mL at post vaccination, for initially seronegative subjects, and at least maintenance of antibody concentration from pre to post-vaccination (i.e. antibody concentration at post vaccination ≥ 1 fold the pre-vaccination antibody concentration), for initially seropositive subjects.|At Month 5|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.||Subjects|||Number
837854|NCT01309646|Secondary|Concentrations of Anti-PRP Antibodies.|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.15 µg/mL.|At Month 0 and Month 5|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.||µg/mL||95% Confidence Interval|Geometric Mean
837855|NCT01309646|Secondary|Number of Seroprotected Subjects for Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibodies.|A seroprotected subject was defined as a vaccinated subject who had an anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (µg/mL).|At Month 0|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.||subjects|||Number
837856|NCT01309646|Secondary|Titres for Anti-polio Types 1, 2 and 3.|Titres were expressed as geometric mean titres (GMTs). The seroprotection cut-off of the assay was 8.|At Month 0 and Month 5|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.||titers||95% Confidence Interval|Geometric Mean
837857|NCT01309646|Secondary|Number of Seroprotected Subjects Anti-poliovirus (Anti-polio) Types 1, 2 and 3.|A seroprotected subject was defined as a vaccinated subject who had an anti-polio types 1, 2 and 3 antibody titres equal to or above (≥) 8, cut off corresponding to the effective dose for 50% of the vaccinated subjects.|At Month 0|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.||subjects|||Number
837858|NCT01309646|Secondary|Concentrations for Anti-D and Anti-T Antibodies.|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL.|At Month 0 and Month 5|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.||IU/mL||95% Confidence Interval|Geometric Mean
837859|NCT01309646|Secondary|Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.|A seroprotected subject was defined as a vaccinated subject who had an anti-D and anti-T antibody concentration equal to or above (≥) 0.1 international units per milliliter (IU/mL).|At Month 0|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.||subjects|||Number
837860|NCT01309646|Secondary|Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations|Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off of 5 EL.U/mL.|At Month 0|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
837861|NCT01309646|Secondary|Number of Seropositive Subjects for Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN).|A seropositive subjects was defined as a vaccinated subjects who had an anti-PRN, anti-PT and anti-FHA antibody concentration ≥ 5 ELISA units per milliliter (EL.U/mL).|At Month 0 and Month 5|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.||Subjects|||Number
837862|NCT01309646|Primary|Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations.|Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off of 5 ELISA units per milliliter (EL.U/mL).|At Month 5|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
837863|NCT01309646|Primary|Number of Seroprotected Subjects for Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibodies.|A seroprotected subject was defined as a vaccinated subject who had an anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (µg/mL).|At Month 5|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.||Subjects|||Number
837864|NCT01309646|Primary|Number of Seroprotected Subjects for Anti-poliovirus (Anti-polio) Types 1, 2 and 3.|A seroprotected subject was defined as a vaccinated subject who had an anti-polio types 1, 2 and 3 antibody titres equal to or above (≥) 8, cut off corresponding to the effective dose for 50% of the vaccinated subjects.|At Month 5|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.||subjects|||Number
837865|NCT01309646|Primary|Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.|A seroprotected subject was defined as a vaccinated subject who had an anti-D and anti-T antibody concentration equal to or above (≥) 0.1 international units per milliliter (IU/mL).|At Month 5|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.||Subjects|||Number
837866|NCT01309659|Secondary|Correlation Between Baseline Soluble Transferrin Receptor Index (Soluble Receptor/Log Ferritin) and the Change in the 6 Minute Walk Test Distance|Correlation between baseline soluble transferrin receptor index (soluble receptor/log ferritin) and the change in the 6 Minute Walk Test Distance from baseline to 12 weeks|baseline, 12 weeks|All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random. Four subjects were missing responses in the immediate intervention group and four subjects were missing responses in the wait list control group.||correlation coefficient|||Number
837867|NCT01309659|Secondary|Correlation Between Baseline Soluble Transferrin Receptor and the Change in the 6 Meter Walk Test Distance|Correlation between baseline soluble transferrin receptor and the change in the 6 Meter Walk Test distance from baseline to 12 weeks|baseline, 12 weeks|All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random. One subject was missing responses in the immediate intervention group and one subject was missing responses in the wait list control group.||correlation coefficient|||Number
837868|NCT01309659|Secondary|Correlation Between Baseline Serum Ferritin, Serum Iron, and Transferrin Saturation and the Change in 6 Minute Walk Test Distance|Correlation between baseline serum ferritin, serum iron, and transferrin saturation and the change in 6 Minute Walk Test distance from baseline to 12 weeks.|baseline, 12 weeks|All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random. One subject was missing responses from the wait list control group.||correlation coefficient|||Number
837869|NCT01309659|Secondary|Correlation Between Baseline Soluble Transferrin Receptor Index (Soluble Receptor/Log Ferritin) and the Change in Hemoglobin|Correlation between baseline soluble transferrin receptor index (soluble receptor/log ferritin) and the change in hemoglobin from baseline to 12 weeks.|baseline, 12 weeks|All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random. Four subjects were missing responses from both the immediate intervention group and the wait list control group.||correlation coefficient|||Number
837870|NCT01309659|Secondary|Correlation Between Baseline Soluble Transferrin Receptor and the Change in HB From Baseline to 12 Weeks|Correlation between baseline soluble transferrin receptor and the change in hemoglobin from the baseline to 12 weeks.|baseline, 12 weeks|All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random. One subject in both the immediate intervention and the wait list control groups were missing responses.||correlation coefficient|||Number
837871|NCT01309659|Secondary|Change in Frailty Component as Determined by the 4 Meter Walk Speed|"To quantify the impact of anemia treatment by IV iron sucrose on change in the speed of the 4 meter walk speed. Subjects are asked to walk as fast as they can for 4 meters. Frailty was determined by the subject's speed. (change from frail at baseline to not frail at week 12). 4 m walking speed is stratified by gender and height. For men, (height of <= 173 cm and a walking speed of <= 0.65 meter/sec) or a (height > 173, <= .76 meter/sec) were classified as frail. For women, (height of <= 159 cm and a walking speed of <=.65 meter/sec) or (height >159 cm <= 0.76 meter/sec) were classified as frail.The outcome is the number of participants who were classified as “frail” at baseline and changed to “not frail” at week 12."|Baseline, 12 weeks|All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random. Five subjects were missing responses in the immediate intervention group and four subjects were missing responses in the wait list control group.||participants|||Number
837872|NCT01309659|Secondary|Change in Frailty Component as Determined by Grip Strength|"To quantify the impact of anemia treatment by IV iron sucrose on change in the frailty as measured by change in grip strength. Subjects squeeze the grip strength machine 3 times with each hand. For the frailty outcome the maximum grip strength from the dominant hand is used. (change from frail at baseline to not frail at week 12). Grip strength is stratified by gender and BMI. For men with (BMI <= 24 and a grip strength (GS) <= 29) or (BMI 24.1-28 and grip strength <= 30) or (BMI >28 and a grip strength <= 32) were classified as frail. For women with (BMI <= 23 and a grip strength of <= 17) or (BMI 23.1-26 and a GS <= 17.3) or (BMI 26.1-29 and a GS <= 18) or (BMI > 29 and a GS <= 21) were classified as frail.The outcome is the number of participants who were classified as “frail” at baseline and changed to “not frail” at week 12."|Baseline, 12 weeks|All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random. Three subjects in both the immediate intervention group and the wait list control groups were missing responses.||participants|||Number
837873|NCT01309659|Secondary|Change in the Frailty Component as Determined by Self-reported Activity Level|To quantify the impact of anemia treatment by IV iron sucrose on change in the frailty as measured by change in self-reported activity level. Frailty for activity level is classified by subjects responses to 6physical activity questions on the short version of the Minnesota Leisure Time Activity Questionnaire , were related to walking for exercise, moderately strenuous outdoor chores, dancing, bowling, and regular exercise. The Women's Health And Aging Study (WHAS) scoring algorithm was used to define frailty for self-reported activity level. The answers to these questions were used to calculate kilocalories (Kcals) per week, using the WHAS algorithm, which is further satisfied by by gender. For men, Kcals < 128 per week is frail. For women, Kcals < 90 per week is frail. This is a categorical measurement of yes or no. The outcome is the number of participants who were classified as “frail” at baseline and changed to “not frail” at week 12.|Baseline, 12 week|All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random. Two subjects in the immediate intervention group and 5 subjects in the wait list group did not respond.||participants|||Number
837874|NCT01309659|Secondary|Change in Self Reported Outcomes Measures as Reported by FACIT-AN Total Score|To quantify the impact of anemia treatment by IV iron sucrose on self -reported outcomes measures by subjects answering 47 questions for patients with anemia and or fatigue. This test detects self-report functional changes and QoL. Change from baseline to 12 weeks. Scores range from 0-188 with higher scores indicating better function.|Baseline, 12 weeks|All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random.The number of participants analyzed is correct as for each of the groups there was missing responses for subjects.||change in the total score||Standard Deviation|Mean
837875|NCT01309659|Secondary|Change in Cognitive Outcome Measures as Determined by Composite Learning and Memory|To quantify the impact of anemia treatment by IV iron sucrose on cognitive outcomes based on Learning and memory was derived using the z-scores of the following three tests: (1) CogState ISL immediate recall score (total score from three learning trials), (2) CogState ISL immediate recall score from the first learning trial, and (3) CogState ISL delayed recall scores. The composite score for a subject at each time point was defined as the mean of the Z-scores for the three tests at the time point. For each subject, the Z-score for each test at time point was derived by subtracting the overall baseline mean of the test from the subject's score at the time point and then dividing by the overall baseline standard deviation of the test. Higher numbers indicated a better response.There is no scale, as the results are normalized variables.|Baseline, 12 week|All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random.The number of participants analyzed is correct as 2 subjects for each of the groups did not have a response for this data.||change in Z-score||Standard Deviation|Mean
837876|NCT01309659|Secondary|Change in Cognitive Outcome Measures as Determined by Composite Complex Attention/Executive Processing|To quantify the impact of anemia treatment by IV iron sucrose on cognitive outcomes based on Complex attention/executive processing was derived using the z-scores of the following three tests: (1) TMT Part B seconds per completed circle, (2) time score from the CogState One Back Task, and (3) accuracy score from the CogState One Back Task. The composite score for a subject at each time point was defined as the mean of the Z-scores for the three tests at the time point. For each subject, the Z-score for each test at time point was derived by subtracting the overall baseline mean of the test from the subject's score at the time point (accuracy score) or by subtracting the subject's score at the time point from the overall baseline mean of the test (TMT and time score) and then dividing by the overall baseline standard deviation of the test.|Baseline, 12 week|All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random.The number of participants analyzed is correct as 1 subject for the Wait List Control did not respond to this during their clinic visit.||change in Z-score||Standard Deviation|Mean
837877|NCT01309659|Secondary|Change in Cognitive Outcome Measures as Determined by Speed of Processing|To quantify the impact of anemia treatment by IV iron sucrose on cognitive outcomes based on speed of processing was derived using the z-scores of the following three tests: (1) TMT Part A seconds per completed circle, (2) simple reaction time from the CogState Detection Task, and (3) choice reaction time from the CogState Identification Task. The composite score for a subject at each time point was defined as the mean of the Z-scores for the three tests at the time point. For each subject, the Z-score for each test at time point was derived by subtracting the subject's score at the time point from the overall baseline mean of the test and then dividing by the overall baseline standard deviation of the test. Positive z-scores indicate a better performance compared to the baseline average.|Baseline, 12 Week|All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random.The number of participants analyzed is correct as 1 subject for the Immediate Intervention Group did not respond to this during their clinic visit.||change in Z-Score||Standard Deviation|Mean
837878|NCT01309659|Secondary|Change in Frailty Component Related to Fatigue/ Exhaustion|"Subjective fatigue/exhaustion: If any of the following three criteria are met, the patient will be classified as frail for fatigue/exhaustion:
“In the past month, on average, have you been feeling unusually tired during the day?” is answered “yes” and indicated as “all of the time” or “most of the time.”
“In the past month, on average, have you felt unusually weak?” is answered “yes” and indicated as “all of the time” or “most of the time.”
Energy level on a scale of 0 (no energy) to 10 (most energy) reported as ≤ 3. If the subject answers YES to any of the above noted 3 questions, then they are classified as FRAIL.
The change in frailty for fatigue/ exhaustion is defined as changing from frail at baseline to not frail at week 12 as reported by the subject."|baseline, 12 weeks|All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random. Results reported by number of participants reporting change from their baseline exhaustion, and low energy.||participants|||Number
837879|NCT01309659|Secondary|Correlation Between Baseline Serum Ferritin, Serum Iron, and Transferrin Saturation and the Change in Hemoglobin (HB)|Correlation between baseline serum ferritin, serum iron, and transferrin saturation and the change in HB from baseline to 12 weeks.|baseline, 12 weeks|All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random.||correlation coefficient|||Number
837880|NCT01309659|Secondary|Change in Self Reported Outcomes Measures as Reported by Short Form-36 (SF-36) Physical Component Score (PCS)|To quantify the impact of anemia treatment by IV iron sucrose on self-reported outcomes measures by change in SF36 physical component score. The SF-36 form identifies self-report physical function and global measure of quality of life and is a multi-purpose, short-form health survey consisting of 36 questions. The Physical Component Summary (PCS) is a subscale of the SF-36 that correlates with physical health domains of the SF-36 ( Physical Function, Role-Physical, and Bodily Pain). The change is calculated and compared from baseline to week 12. The SF-36 PCS score is a norm based sore with a mean of 50 and standard deviation of 10 where results above and below 50 are above and below the average, respectively, in the 2009 general US population.|Baseline, 12 weeks|All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random. Number of participants analyzed is correct- 2 subjects for Waitlist Group did not respond.||t score||Standard Deviation|Mean
837881|NCT01309659|Secondary|Change in Cognitive Outcome Measures as Determined by Trail Making Test Part B|To quantify the impact of anemia treatment by IV iron sucrose on cognitive outcomes based on the Trail Making Test (TMT) Part B as measured by subjects drawing a line from 25 circled numbers to letters in 300 seconds. The change in seconds per completed circle from baseline to week 12.|Baseline, 12 weeks|All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random. The number of participants analyzed is correct as 4 subjects for the wait list control group did not respond to this during their clinic visit.||change in seconds per completed circle||Standard Deviation|Mean
837882|NCT01309659|Secondary|Number of Participants Who Had a Hemoglobin Increase >= 1g/dL|To assess the efficacy of IV iron sucrose in improving Hemoglobin by at least 1 g/dL; an increase from baseline to week 12.|baseline, 12 weeks|||participants|||Number
837883|NCT01309659|Primary|Change in 6 Minute Walk Test Results|Subjects were asked to walk for 6 minutes, unassisted. The distance walked was recorded in meters at baseline (time of randomization) and 12 weeks after baseline (time of randomization). The change from baseline to 12 weeks, related to distance, is compared and documented.|Baseline, 12 weeks|All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random.||meters||Standard Deviation|Mean
837884|NCT01309672|Secondary|Number of Patients With Toxicity of Abiraterone Acetate|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Up to 3 years|All participants receiving at least some protocol treatment||Participants|||Number
837885|NCT01309672|Secondary|Overall Survival||3 years|||months||95% Confidence Interval|Median
837886|NCT01309672|Secondary|Objective Progression-free Survival|Progression defined as unequivocal progression of disease, progressive disease as defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), progressive disease as defined by the Prostate Cancer Clinical Trials Working Group bone scan progression criteria, or death due to disease.|3 years|||months||95% Confidence Interval|Median
837887|NCT01309672|Secondary|Number of Patients With PSA Partial Response|PSA reduction to < 4 ng/ml, but >0.2 ng/ml|12 months|||Participants|||Count of Participants
837888|NCT01309672|Primary|Number of Patients With Undetectable PSA|undetectable PSA defined as <= 0.2 ng/mL. Patients not responding in the first year were deemed non-responders.|12 months|All patients who received at least 1 dose of protocol treatment||Participants|||Count of Participants
837962|NCT01309841|Primary|Response (Responder/Non-responder) to Study Drug During Weeks 1 to 12|Responder was defined as having at least 3 spontaneous bowel movements (SBMs)/week with at least 1 SBM/week increase over baseline for at least 9 out of the 12 treatment weeks and 3 out of the last 4 treatment weeks during the double-blind treatment period. An SBM is a bowel movement occurring 24 hours or more since the last use of rescue medication.|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients, with the exception of patients who were found to have randomized multiple times within the program at different centers.||Number of patients|||Number
837963|NCT01309880|Secondary|Comfort|At 1-Week Follow-up, participants rated lens comfort on a scale of 0 to 100, with 100 being the most favorable score.|1 Weeks|||units on a scale|Participants|Standard Deviation|Least Squares Mean
837964|NCT01309880|Secondary|Slit Lamp Findings|Measured on a scale of 0-4 where 0=none, 1=trace, 2=mild, 3=moderate, and 4=severe for edema, microcysts, corneal staining, limbal injection, bulbar injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization and corneal infiltrates.|1 week|All Dispensed Eyes||eyes|Participants||Number
837965|NCT01309880|Primary|Visual Acuity|Distance high contrast logMAR lens visual acuity (VA) between the Air Optix Aqua lens and the Test Lens at Dispensing and at 1-Week Follow-up.|Dispensing & 1-week follow up|All Eligible, Dispensed Eyes||logMAR|Participants|Standard Deviation|Least Squares Mean
837966|NCT01309893|Secondary|Overall Comfort|Comfort measured by participant on a scale of 0-100 with 100 being the most favorable.|1 week|All eligible dispensed eyes||units on a scale|Participants|Standard Deviation|Least Squares Mean
838092|NCT01311661|Secondary|Mean Pre-dose Morning FEV1 (FEV1 a.m.)|FEV1 a.m. was measured by patients at home using the AM3 device (overall means obtained during each period of randomised treatment will be compared). Means are adjusted for treatment, period, patient and study baseline.|0-3 weeks|FAS||mL||Standard Error|Mean
838353|NCT01315158|Secondary|Number of Participants Who Experience Other Sedation Related Complications|Compare the number of participants who experience other sedation related complications such as hypotension, hypoxemia and need for termination of the procedure between the two groups|One day (during procedure)|||participants|||Number
838354|NCT01315158|Primary|Number of Participants Who Experience Airway Maneuvers|In high risk patients (meeting at least of 1 of 3 criteria: ASA ≥ 3, BMI ≥ 30, those at risk for OSA) undergoing advanced endoscopy procedures, compare the number of participants who experience airway maneuvers (AMs) when sedated with propofol alone versus propofol in combination with benzodiazepines and opioids.|One day (during procedure)|||participants|||Number
837942|NCT01309802|Secondary|EQ-5D A Standardised Patient Reported Measure of Health Status for Clinical and Economic Appraisal|A combined reported score measuring 5 dimensions; mobility, self care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels; no problems, some problems, extreme problems|baseline to 28 days|not were not collected|||||
837943|NCT01309802|Secondary|Tissue Perfusion|Doppler perfusion imager and Periscan image analysis software|baseline to 28 days|Data were not collected|||||
837944|NCT01309802|Secondary|Patient Satisfaction|The Optum SF-12v2® Health Survey - A Short Patient Reported Survey Measuring Health Using Excellent, Very Good, Good, Fair and Poor Indicators. On a scale from Excellent to Poor, Excellent being the maximum outcome. Good is scored as average. Patient satisfaction assessed as the percentage of participants who responded; Excellent, Very Good and Good on the health survey on average feeling between baseline and 28 days.|baseline to 28 days|||percentage of participants|||Number
837945|NCT01309802|Secondary|Hand Function|Quick-DASH (Disabilities of the Arm, Shoulder, and Hand) Outcome Measure|baseline to 28 days|Data were not collected|||||
837946|NCT01309802|Secondary|Quality of Life|SF-12v2® Health Survey - Pain Enhanced|change from baseline to 28 days|Data were not collected,|||||
837947|NCT01309802|Primary|Percentage of Patient Reported Pain-free Days|Subjective pain scales [visual analogue scale (VAS) and faces pain assessment]. Subjects reporting total number of pain free days within the time period of 0-28 days.|baseline to 28 days|||percentage of pain free days|||Number
837948|NCT01309828|Secondary|Percentage of Participants at Final Visit Who Achieved Both a Clinic Systolic and Diastolic Blood Pressure Response|Systolic/diastolic blood pressure is the arithmetic mean of the 3 serial sitting systolic/diastolic blood pressure measurements. Percentage of participants who achieved both a sitting clinic systolic and diastolic blood pressure response, defined as systolic blood pressure less than 130 mm Hg and diastolic blood pressure less than 80 mm Hg at Week 52.|Week 52|Full analysis set participants (all randomized participants who received at least 1 dose of open-label study drug) with both Baseline and a post-baseline value; last observation carried forward was used.||percentage of participants||95% Confidence Interval|Number
837949|NCT01309828|Secondary|Percentage of Participants at Final Visit Who Achieved Target Diastolic Blood Pressure <80 mm Hg|Diastolic blood pressure is the arithmetic mean of the 3 serial sitting diastolic blood pressure measurements. Percentage of participants at Week 52 who achieved a sitting clinic diastolic blood pressure response, defined as less than 80 mm Hg.|Week 52|Full analysis set participants (all randomized participants who received at least 1 dose of open-label study drug) with both Baseline and a post-baseline value; last observation carried forward was used.||percentage of participants||95% Confidence Interval|Number
837950|NCT01309828|Secondary|Percentage of Participants at Final Visit Who Achieve Target Systolic Blood Pressure <130 mm Hg|Systolic blood pressure is the arithmetic mean of the 3 serial sitting systolic blood pressure measurements. Percentage of participants who achieve a sitting clinic systolic blood pressure response defined as less than 130 mm Hg at Week 52.|Week 52|Full analysis set participants (all randomized participants who received at least 1 dose of open-label study drug) with both Baseline and a post-baseline value; last observation carried forward was used.||percentage of participants||95% Confidence Interval|Number
837951|NCT01309828|Primary|Number of Participants With at Least 1 Adverse Event (AE)|An AE is any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have a causal relationship with this treatment. A serious AE is defined as any untoward medical occurrence that resulted in death, was life threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability or incapacity, led to a congenital anomaly/birth defect or was an important medical event that may have required intervention to prevent any of items above.|From the first dose of open-label study drug until 14 days (or 30 days for a serious adverse event) after the last dose of open- label study drug (up to 56 weeks).|Safety analysis set - All participants who received at least 1 dose of open-label study drug.||participants|||Number
837967|NCT01309893|Secondary|Slit Lamp Findings ≥ Grade 2|Slit lamp findings are measured on a scale of 0-4, where 0=none, and 4=severe. The slit lamp exam is a routine procedure done to evaluate eye health and determine eligibility for clinical trial. It provides view of the different parts of the eye. During the exam, a doctor can look at the front parts of the eye, including the cornea, the lens, the iris and other parts of the anterior segment of the eye. Fluorescein dye may be used during a slit lamp examination to make it easier to detect inflammation, infections, or injured area on the cornea.|1 week|All dispensed eyes||eyes|Participants||Number
837952|NCT01309841|Secondary|Change From Baseline in Patient Assessment of Constipation Quality of Life (PAC-QOL) Satisfaction Domain|The PAC-QOL scale is a 28-item self-report instrument designed to evaluate the burden of constipation on patients’ everyday functioning and well-being in the 2 weeks (14 days) prior to assessment. Each item is rated on a 5-point Likert scale ranging from 0 (not at all) to 4 (extremely). The instrument can be used to generate an overall score, but is also reported to assess 4 specific constipation-related domains including: 1) Worries and concerns (11 items), 2) Physical discomfort (4 items), 3) Psychosocial discomfort (8 items), and 4) Satisfaction (5 items). Each domain score is the mean of the non-missing items for that domain. The total score is the mean of all non-missing items. The range of the domain or total score is 0 (response is 'not at all' for each item) to 4 (response is 'extremely' for each item). A negative change from baseline indicates improvement.|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients who had evaluable data at baseline and post-baseline, with the exception of patients who randomized multiple times at different centers. MMRM analysis includes all patients with baseline and at least 1 post-baseline assessment, while the Ns at Week 12 reflect patients providing data at Week 12.||units on a scale||Standard Error|Least Squares Mean
837953|NCT01309841|Secondary|Change From Baseline in Patient Assessment of Constipation Symptoms Questionnaire (PAC-SYM)|The PAC-SYM questionnaire is a 12-item questionnaire that evaluates the severity of symptoms of constipation in 3 domains (stool, rectal, and abdominal symptoms) on a 5-point Likert scale ranging from 0 (absent) to 4 (very severe) in the 2 weeks (14 days) prior to assessment. Each domain score is the mean of the non-missing items for that domain. The total score is the mean of all non-missing items (ie, symptoms). The range of the domain or total score is 0 (response is 'absent' for each item) to 4 (response is 'very severe' for each item). A negative change from baseline indicates improvement.|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients who had evaluable data at baseline and post-baseline, with the exception of patients who randomized multiple times at different centers. MMRM analysis includes all patients with baseline and at least 1 post-baseline assessment, while the Ns at Week 12 reflect patients providing data at Week 12.||units on a scale||Standard Error|Least Squares Mean
837954|NCT01309841|Secondary|Time (in Hours) to First Post-dose Laxation Without the Use of Rescue Laxatives Within the Previous 24 Hours in the Laxative Inadequate Response (LIR) Subgroup|Time to first post-dose laxation without the use of rescue laxatives within the last 24 hours was calculated in hours as: Date/Time of first post-dose laxation without rescue – First dose date/time.|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients, with the exception of patients who were found to have randomized multiple times within the program at different centers.||hours||95% Confidence Interval|Median
837955|NCT01309841|Secondary|Change From Baseline in Mean Spontaneous Bowel Movements/Week|The number of spontaneous bowel movements/week was determined from the patient's eDiary.|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients who had evaluable data at baseline and post-baseline, with the exception of patients who were found to have randomized multiple times within the program at different centers.||Number of SBMs/week||Standard Error|Least Squares Mean
837956|NCT01309841|Secondary|Change From Baseline in Percent Numbers of Days With a CSBM (Complete Spontaneous Bowel Movement)|A single-item question on the completeness of evacuation, developed and validated through 1:1 interviews with OIC patients, was asked via the eDiary: “Did you feel like your bowels were completely empty after the bowel movement?” Patients provided a yes or a no response. A positive change from baseline indicates improvement.|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients who had evaluable data at baseline and post-baseline, with the exception of patients who were found to have randomized multiple times within the program at different centers.||Percent days/week||Standard Error|Least Squares Mean
837957|NCT01309841|Secondary|Change From Baseline in Stool Consistency (Bristol Stool Scale)|Patients rated stool consistency through completion of the BSS after each BM. The 7 stool types are: 1. Separate hard lumps, like nuts (hard to pass); 2. Sausage-shaped, but lumpy; 3. Like sausage, but with cracks on its surface; 4. Like a sausage or snake, smooth and soft; 5. Soft blobs with clear cut edges (passed easily); 6. Fluffy pieces with ragged edges, a mushy stool; 7. Watery, no solid pieces. A positive change from baseline indicates improvement.|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients who had evaluable data at baseline and post-baseline, with the exception of patients who were found to have randomized multiple times within the program at different centers.||units on a scale||Standard Error|Least Squares Mean
837958|NCT01309841|Secondary|Change From Baseline in Degree of Straining|A single-item straining question was asked via the eDiary: “How much did you strain during your bowel movement?” Patients responded on a 5 point Likert scale: 1=Not at all; 2=A little bit; 3=A moderate amount; 4=A great deal; 5=An extreme amount. A negative change from baseline indicates improvement.|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients who had evaluable data at baseline and post-baseline, with the exception of patients who were found to have randomized multiple times within the program at different centers.||units on a scale||Standard Error|Least Squares Mean
837959|NCT01309841|Secondary|Change From Baseline in Mean Number of Days Per Week With at Least 1 SBM During Weeks 1 to 12||12 weeks|The ITT analysis set included all randomized patients who had evaluable data at baseline and post-baseline, with the exception of patients who were found to have randomized multiple times within the program at different centers.||Number of Days||Standard Error|Least Squares Mean
837960|NCT01309841|Secondary|Time (in Hours) to First Post-dose Laxation Without the Use of Rescue Laxatives Within the Previous 24 Hours||12 weeks|The ITT analysis set included all randomized patients, with the exception of patients who were found to have randomized multiple times within the program at different centers.||Hours||95% Confidence Interval|Median
837961|NCT01309841|Secondary|Response (Responder/Non-responder) to Study Drug in the LIR Subgroup During Weeks 1 to 12|Responder is defined as having at least 3 SBMs/week, with at least 1 SBM/week increase over baseline for at least 9 out of 12 weeks and at least 3 out of the last 4 weeks.|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients, with the exception of patients who were found to have randomized multiple times within the program at different centers. The LIR subgroup used 1 or more laxative classes for at least 4 days in the 2 weeks prior to entry and reported moderate to very severe symptoms.||Number of patients|||Number
837975|NCT01309997|Secondary|Baseline Histopathologic Score in the Two Treatment Arms|"Instrument: Nash dermal fibrosis grade. Measures extent of sclerosis in skin biopsies by histologic examination. Scale ranges from grade 0-5. Nash grade 5 is most severe fibrosis (0 is better outcome, 5 is worse outcome). No subscales are used in Nash grade. Please see table 1 in the reference for grading of dermal fibrosis.
Nash RA, McSweeney PA, Crofford LJ, Abidi M, Chen CS, Godwin JD, et al. High-dose immunosuppressive therapy and autologous hematopoietic cell transplantation for severe systemic sclerosis: long-term follow-up of the US multicenter pilot study. Blood 2007;110:1388-96."|Enrollment|Only patients with skin biopsies at enrollment are included.||units on a scale||Full Range|Median
837976|NCT01309997|Secondary|Number of Patients Achieving Improvement in Cutaneous Sclerosis|Assessed by decrease of >= 0.2 units (where 0 is best and 3.0 is worst ) in the Scleroderma Health Assessment Questionnaire (SHAQ).|6 months|Only patients evaluable at 6 mo are included.||participants|||Number
837977|NCT01309997|Secondary|Cumulative Incidence of Treatment Failure|Defined as discontinuation of randomized treatment due to chronic GVHD progression or treatment intolerance or no significant clinical response in sclerosis.|6 months|Only patients who were evaluable for SCR are included.||participants|||Number
837978|NCT01309997|Secondary|Patients Who Were Able to Taper Corticosteroids|Patients who achieved a greater than or equal to 50% reduction in the daily corticosteroid dose at 6mo compared to baseline|6 months|Patients with no corticosteroid dose data missing from baseline or 6mo.||participants|||Number
837979|NCT01309997|Primary|Significant Clinical Response|Assessed by decline in an affected area’s skin score as measured with the Vienna Skin Scale (from 4 [worst] to 2, 3 to 1, or 2 to 0 [best]) without a concurrent increase of two or more points in another area OR by an increase in the range of motion of the shoulders, elbows or wrists by two points (in a 1-7 scale where 1 is worst and 7 is best) or of the ankles by one point (in a 1 to 4 scale where 1 is worst and 4 is best) without a concurrent worsening in another area.|6 months|Patients were not eligible for evaluation if they discontinued participation or had missing 6 mo data.||participants|||Number
837980|NCT01310127|Primary|Macular Volume|Stratus OCT by experienced technician. Reviewed by principal investigator for quality of foveal centration and signal strength|6 weeks|||mm cubed||Standard Deviation|Mean
837981|NCT01310127|Primary|OCT Retinal Thickness|Stratus OCT scan retinal thickness/volume tabular output report. An experienced ophthalmic technician obtained two scan patterns. The first was the fast macular thickness using 6 radial line scans through a common central axis (fovea) with a retinal thickness/volume tabular output and a retinal-thickness output report. Central retinal thickness was defined as the distance between the inner limiting membrane of the retina and the inner border of the choriocapillaris in the central 1 mm area of the minimum 7 mm posterior pole scan. All scans were reviewed by the principal investigator for quality of foveal centration and signal strength. Macular volume is an objective indicator of macualr swelling and can illustrate the amount of inflammation following surgery. Only the study eye was assessed.|Week 6|||micrometers cubed||Standard Deviation|Mean
837982|NCT01310127|Primary|Summed Ocular Inflammation Score (SOIS)|An assessment of the cells and flare, signs of inflammation in ocular tissue. SOIS (summed ocular inflammation) = cells in the anterior chamber/1mmx1mm high powered field+flare/1mmx1mm high powered field. The score of the number of cells in the anterior chamber per 1mmx1mm high powered field ranges from 0-4: 0=no cells, 1=1-5 cell, 2=6-15 cells, 3=16-30 cells, 4>=30 cells.Flare scores range from 0-3:(0=none, 1=mild, 2=moderate, 3=severe). Cell+flare are added together (cell score + flare score=SOIS score) for a SOIS score (minimum score=0 and maximal score of 7). Higher numbers would indicate more inflammation.The SOIS scale could range from 0-7 with 0 indicating no cells, no flare and 7 reflecting maximal cell 4(>30 cell/high powered field +3 (severe flare).|Week 6|||units on a scale||Standard Deviation|Mean
837983|NCT01310127|Primary|Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuities|ETDRs visual acuities measured at week 6 following uncomplicated phacoemulsification (phaco). ETDRS charts are a standardized eye chart for visual acuity testing accepted by the National Eye Institute and the Food and Drug Administration. The scale is 30-90 letters with higher numbers signifying improved visual acuities.|Week 6|||letters||Standard Deviation|Mean
837984|NCT01310179|Secondary|Treatment Outcome and Percent Change in Tumor Volume|Measurement of tumor response to study drug, as measured by the percentage of change in tumor volume as measured by a physicial measurement using a ruler|Entry through Study Day 56|||participants|||Number
837985|NCT01310179|Primary|Number of Participants With Side Effects After Ad/PNP-F-araAMP Treatment|Number of participants who had the most frequently observed undesirable effects after exposure to study drug|Entry through Study Day 56|||participants|||Number
837986|NCT01310400|Secondary|Safety: Incidence of Solicited and Unsolicited Adverse Events|Safety assessements were made by the investigator at baseline and on Days 28 and 49, as well as by the subjects themselves (in Subjects Diaries) for the 4-day period following each vaccination.|Solicited AEs: Days 1-4 and 28-31, and Days 28 and 49; unsolicited AEs: until study end|||percentage of subjects with AEs|||Number
837987|NCT01310400|Secondary|Seroprotection|Seroprotection rate, defined as a post-vaccination HI titer of 1:40.|3 weeks after the 2nd vaccination|||percentage seroprotected subjects||95% Confidence Interval|Number
837988|NCT01310400|Secondary|Fold Increase in Geometric Mean Titer (GMT)|GMT-fold increase - calculated as the GMT on Day 49 divided by the baseline GMT value|3 weeks after the 2nd vaccination|||Fold (ratio)|||Number
837989|NCT01310400|Primary|Immunogenicity, Assessed by the Haemagglutination (HI) Test|Seroconversion rate post-immunization. Seroconversion is defined as a post-vaccination titer of ≥1:40 for those with a pre-vaccination HI titer of <1:10 and as ≥ four-fold increase in HI titer for those with a pre-vaccination HI titer of ≥1:10.|3 weeks after the 2nd vaccination|According-to-protocol population: subjects who received both doses of influenza vaccine, with available pre- and post-vaccination titers and without major protocol violations||percentage of participants||95% Confidence Interval|Number
837990|NCT01310413|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|A SAE was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|From Day U0 up to Day U385|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subject|||Number
837991|NCT01310413|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).|An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. “Any” was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. As the study is still ongoing and data per age group are not available, results are presented for the groups pooled by vaccine/placebo administered. This outcome measure will be amended when data by age group become available.|During the 42-day (Days U0-U41) post-vaccination period following Dose 1 of Influenza A (H5N1) Virus monovalent vaccine|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subject|||Number
837992|NCT01310413|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).|An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. “Any” was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 21-day (Days U21-U41) post-vaccination period following Dose 2 of Influenza A (H5N1) Virus monovalent vaccine|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subject|||Number
837993|NCT01310413|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).|An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. “Any” was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 21-day (Days U0-U20) post-vaccination period following Dose 1 of Influenza A (H5N1) Virus monovalent vaccine|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subject|||Number
837994|NCT01310413|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|A SAE was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|From Day 0 up to Day 385|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subject|||Number
837995|NCT01310413|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).|An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. “Any” was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 42-day (Days 0-41) post-vaccination period following Dose 1 of vaccine/placebo|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subject|||Number
837996|NCT01310413|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).|An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. “Any” was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 21-day (Days 21-41) post-vaccination period following Dose 2 of vaccine/placebo|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subject|||Number
837997|NCT01310413|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).|An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. “Any” was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 21-day (Days 0-20) post-vaccination period following Dose 1 of vaccine/placebo|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subject|||Number
837998|NCT01310413|Secondary|Number of Subjects With Normal and Abnormal Haematological Parameters Assessed With Respect to Red and White Blood Cells (RBC and WBC)|Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.|From Day 0 up to Day 385|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subject|||Number
837999|NCT01310413|Secondary|Number of Subjects With Normal and Abnormal Haematological Parameters Assessed With Respect to Lymphocytes (LYM) and Monocytes (MON)|Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.|From Day 0 up to Day 385|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subject|||Number
838355|NCT01315249|Secondary|Number of Participants With Adverse Events|The assessment of safety was based on Adverse Events. A summary of adverse events is presented with this outcome, additional details are provided in Adverse Events Section.|26 weeks|Safety set includes all participants who received at least one dose of study drug.||participants|||Number
838000|NCT01310413|Secondary|Number of Subjects With Normal and Abnormal Haematological Parameters Assessed With Respect to Neutrophils (NEU) and Platelets (PLA)|Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.|From Day 0 up to Day 385|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subject|||Number
838001|NCT01310413|Secondary|Number of Subjects With Normal and Abnormal Haematological Parameters Assessed With Respect to Haematocrit (Hcr) and Haemoglobin (Hgb)|Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.|From Day 0 up to Day 385|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subject|||Number
838002|NCT01310413|Secondary|Number of Subjects With Normal and Abnormal Haematological Parameters Assessed With Respect to Basophils (BAS) and Eosinophils (EOS)|Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.|From Day 0 up to Day 385|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subject|||Number
838003|NCT01310413|Secondary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Creatinine (CREA) and Blood Urea Nitrogen (BUN)|Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.|From Day 0 up to Day 385|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subject|||Number
838004|NCT01310413|Secondary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Total Bilirubin (T-BIL) and Bilirubin Conjugated/Direct (BIL-C/D)|Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.|From Day 0 up to Day 385|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subject|||Number
838005|NCT01310413|Secondary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALAT) and Aspartate Aminotransferase (ASAT)|Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.|From Day 0 up to Day 385|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subject|||Number
838006|NCT01310413|Secondary|Number of Subjects Reporting Pregnancies, and Outcomes of These Reported Pregnancies||From Day U0 to Day U385|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subject|||Number
838007|NCT01310413|Secondary|Number of Subjects Reporting Pregnancies, and Outcomes of These Reported Pregnancies||From Day 0 up to Day 385|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subject|||Number
838008|NCT01310413|Secondary|Number of Subjects With Any Potential Immune-Mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) were defined as a subset of adverse events that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which might or might not have an autoimmune aetiology. “Any pIMD” was defined as at least one pIMD experienced by the study subject.|From Day U0 to Day U385|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subject|||Number
838009|NCT01310413|Secondary|Number of Subjects With Any Potential Immune-Mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) were defined as a subset of adverse events that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which might or might not have an autoimmune aetiology. “Any pIMD” was defined as at least one pIMD experienced by the study subject.|From Day 0 up to Day 385|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subject|||Number
838010|NCT01310413|Secondary|Number of Subjects With Medically-attended Adverse Events (MAEs)|MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination. Any MAE was defined as atleast 1 MAE experienced.|From Day U0 up to Day U385|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subject|||Number
838011|NCT01310413|Secondary|Number of Subjects With Medically-attended Adverse Events (MAEs)|MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination. Any MAE was defined as atleast 1 MAE experienced.|From Day 0 up to Day 385|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subject|||Number
838012|NCT01310413|Secondary|Number of Subjects at Least 6 Years of Age Reporting Solicited General Symptoms.|Solicited general symptoms assessed in subjects of at least 6 years of age were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches, shivering, sweating and fever [axillary temperature (T) >= 38.0 degrees Celsius (°C)]. Gastrointestinal symptoms included nausea, vomiting, diaorrhea and/or abdominal pain. “Any” was defined as any occurrence of the specified solicited general symptom reported, regardless of intensity or relationship to vaccination. Grade 3 was defined as a general symptom that prevented normal activity. Related was defined as a general symptom assessed by the investigator as causally related to the study vaccination. Grade 3 fever was axillary temperature >= 39.0°C.|During the 7-day (Days U0-U6) post-vaccination periods post Doses 1 and 2 of vaccine/placebo, across doses (Year 2)|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subject|||Number
838093|NCT01311661|Secondary|PEF Daily Variability|PEF daily variability was assessed by patients at home using the AM3 device (overall means obtained during each period of randomised treatment will be compared). PEF daily variability is the absolute difference between the morning and the evening PEF value divided by the mean of these two values, expressed as a percent. Means are adjusted for treatment, period, patient and study baseline.|0-3 weeks|FAS||Percentage||Standard Error|Mean
838013|NCT01310413|Secondary|Number of Subjects at Least 6 Years of Age Reporting Solicited General Symptoms.|Solicited general symptoms assessed in subjects of at least 6 years of age were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches, shivering, sweating and fever [axillary temperature (T) >= 38.0 degrees Celsius (°C)]. Gastrointestinal symptoms included nausea, vomiting, diaorrhea and/or abdominal pain. “Any” was defined as any occurrence of the specified solicited general symptom reported, regardless of intensity or relationship to vaccination. Grade 3 was defined as a general symptom that prevented normal activity. Related was defined as a general symptom assessed by the investigator as causally related to the study vaccination. Grade 3 fever was axillary temperature >= 39.0°C.|During the 7-day (Days 0-6) post-vaccination periods post Doses 1 and 2 of vaccine/placebo, across doses (Year 1)|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subject|||Number
838014|NCT01310413|Secondary|Number of Subjects of Less Than 6 Years of Age Reporting Solicited General Symptoms.|Solicited general symptoms assessed in subjects of less than 6 years of age were drowsiness, irritability/fussiness, loss of appetite and fever [axillary temperature (T) higher than or equal to (>=) 38.0 degrees Celsius (°C)]. “Any” was defined as any occurrence of the specified solicited general symptom reported, regardless of intensity or relationship to vaccination. Grade 3 was defined as a general symptom that prevented normal activity. Related was defined as a general symptom assessed by the investigator as causally related to the study vaccination. Any fever was defined as axillary temperature above 38.0 degrees Celsius (°C). Grade 3 fever was axillary temperature >=39.0°C.|During the 7-day (Days U0-U6) post-vaccination periods post Doses 1 and 2 of vaccine/placebo, across doses (Year 2)|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subject|||Number
838015|NCT01310413|Secondary|Number of Subjects of Less Than 6 Years of Age Reporting Solicited General Symptoms.|Solicited general symptoms assessed in subjects of less than 6 years of age were drowsiness, irritability/fussiness, loss of appetite and fever [axillary temperature (T) higher than or equal to (>=) 38.0 degrees Celsius (°C)]. “Any” was defined as any occurrence of the specified solicited general symptom reported, regardless of intensity or relationship to vaccination. Grade 3 was defined as a general symptom that prevented normal activity. Related was defined as a general symptom assessed by the investigator as causally related to the study vaccination. Any fever was defined as axillary temperature above 38.0 degrees Celsius (°C). Grade 3 fever was axillary temperature >= 39.0°C.|During the 7-day (Days 0-6) post-vaccination periods post Doses 1 and 2 of vaccine/placebo, across doses (Year 1)|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subject|||Number
838016|NCT01310413|Secondary|Number of Subjects Reporting Solicited Local Symptoms.|Solicited local symptoms assessed were pain and swelling. “Any” was defined as any occurrence of the specified solicited local symptom reported, regardless of intensity. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 100 millimeter (mm).|During the 7-day (Days U0-U6) post-vaccination periods post Doses 1 and 2 of vaccine/placebo, across doses (Year 2)|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subject|||Number
838017|NCT01310413|Secondary|Number of Subjects Reporting Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling. “Any” was defined as any occurrence of the specified solicited local symptom reported, regardless of intensity. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 100 millimeter (mm).|During the 7-day (Days 0-6) post-vaccination periods post Doses 1 and 2 of vaccine/placebo, across doses (Year 1)|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented, solely on subjects with results available/accessible.||Subject|||Number
838018|NCT01310413|Secondary|Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the H5N1 A/Indonesia and H5N1 A/Vietnam Virus Strains.|VRR for MN was defined as as the incidence rate of vaccinees with a 4-fold increase in post vaccination reciprocal titer relative to Day 0.|At Day 42|Analysis was done on the Day 42 According-to-Protocol cohort for immunogenicity, that is, all evaluable subjects with 2 doses of vaccine/placebo administered and for whom assay results for antibodies against vaccine-homologous H5N1 haemagglutinin (HA) antigen were available for the Days 0 and 42 time points.||Subject|||Number
838019|NCT01310413|Secondary|Number of Subjects Seropositive for Microneutralization (MN) Antibodies Against the H5N1 A/Indonesia Virus Strain.||At Days 0 and 42|Analysis was done on the Day 42 According-to-Protocol cohort for immunogenicity, that is, all evaluable subjects with 2 doses of vaccine/placebo administered and for whom assay results for antibodies against vaccine-homologous H5N1 haemagglutinin (HA) antigen were available for the Days 0 and 42 time points.||Subject|||Number
838020|NCT01310413|Secondary|Microneutralization (MN) Antibody Titers Against the H5N1 A/Indonesia and H5N1 A/Vietnam Virus Strains.|MN HI antibody titers against the H5N1 A/Indonesia (A/INDO) and H5N1 A/Vietnam (A/VIET) virus strains were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of higher than or equal to (>=) 1:28.|At Days 0, 42, 182 and 385|Analysis was done on the Day 42, 182 and 385 ATP cohorts for immunogenicity, that is, 50 percent of the evaluable subjects with 2 doses of vaccine/placebo administered and for whom assay results for antibodies against vaccine-homologous H5N1 haemagglutinin (HA) antigen were available for the Days 0, 42, 182 and 385 time points.||Titer||95% Confidence Interval|Geometric Mean
838021|NCT01310413|Secondary|Geometric Mean Increase (GMI) for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain.|GMI also known as the seroconversion factor (SCF) or geometric mean fold rise (GMFR) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.|At Day 385.|The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 385, which included 50% of evaluable subjects who received 2 doses of the study vaccine/placebo at Days 0 and 21 and for whom assay results for antibodies against vaccine-homologous H5N1 HA antigen for the blood samples taken at Days 0 and 385 were available||Fold increase||95% Confidence Interval|Geometric Mean
839994|NCT01330394|Secondary|Cognitive Tasks|Cognitive tests comprised by Frontal Assessment Battery (FAB), verbal n-back task, visuospatial n-back task, go-no-go task, counting Stroop, will be done at the beginning of the session 1 and session 6 (one week after the 5 sessions of sham or tDCS).|one year and a half||||||
838022|NCT01310413|Secondary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain.|A subject seroconverted for HI antibodies against the H5N1 A/Indonesia virus strain (A/INDO) was defined as a vaccinee with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer higher than or equal to (>=) 1:40, or with a pre-vaccination titer >= 1:10 and at least a 4-fold increase in post-vaccination titer.|At Day 385|The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 385, which included 50% of evaluable subjects who received 2 doses of the study vaccine/placebo at Days 0 and 21 and for whom assay results for antibodies against vaccine-homologous H5N1 HA antigen for the blood samples taken at Days 0 and 385 were available||Subjects|||Number
838023|NCT01310413|Secondary|Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain.|"A seroprotected subject against the a/Indonesia/5/2005 (A/INDO) virus strain was defined as a subject with H5N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (>=) the seroprotection cut-off of 1:40.
As the analyses were performed and disclosed stepwise – i.e. as soon as a study phase was completed – several releases of the CTRS (result summaries) were published. To generate an integrated Clinical Study Report, one set of domain datasets covering all analyses was used and the Adapted ATP cohort for immunogenicity has been defined. As a consequence, some of the data previously disclosed and based on ATP cohort for immunogenicity at Day 42, Day 182 and Day 385 have been replaced in this summary with data generated with the Adapted ATP cohort for immunogenicity."|At Day 0 and Day 385|Adapted ATP cohort for immunogenicity included all evaluable subjects for which Day 21 and Day 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Day 182 data were obtained from the ATP cohort for immunogenicity at Day 182, and Day 385 data were obtained from the ATP cohort for immunogenicity at Day 385.||Subjects|||Number
838024|NCT01310413|Secondary|Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain.|"HI antibody titers against the H5N1 A/Indonesia virus strain (A/INDO) were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of higher than or equal to (>=) 1:10.
As the analyses were performed and disclosed stepwise – i.e. as soon as a study phase was completed – several releases of the CTRS (result summaries) were published. To generate an integrated Clinical Study Report, one set of domain datasets covering all analyses was used and the Adapted ATP cohort for immunogenicity has been defined. As a consequence, some of the data previously disclosed and based on ATP cohort for immunogenicity at Day 42, Day 182 and Day 385 have been replaced in this summary with data generated with the Adapted ATP cohort for immunogenicity."|At Day 0 and Day 385|Adapted ATP cohort for immunogenicity included all evaluable subjects for which Day 21 and Day 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Day 182 data were obtained from the ATP cohort for immunogenicity at Day 182, and Day 385 data were obtained from the ATP cohort for immunogenicity at Day 385.||Titer||95% Confidence Interval|Geometric Mean
838025|NCT01310413|Secondary|Geometric Mean Increase (GMI) for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain.|GMI also known as the seroconversion factor (SCF) or geometric mean fold rise (GMFR) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titre to the pre-vaccination reciprocal HI titre for the vaccine virus.|At Day 182|The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 182, which included 50% of evaluable subjects who received 2 doses of the study vaccine/placebo at Days 0 and 21 and for whom assay results for antibodies against vaccine-homologous H5N1 HA antigen for the blood samples taken at Days 0 and 182 were available||Ratio||95% Confidence Interval|Geometric Mean
838026|NCT01310413|Secondary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain.|A subject seroconverted for HI antibodies against the H5N1 A/Indonesia virus strain (A/INDO) was defined as a vaccinee with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer higher than or equal to (>=) 1:40, or with a pre-vaccination titer >= 1:10 and at least a 4-fold increase in post-vaccination titer.|At Day 182|The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 182, which included 50% of evaluable subjects who received 2 doses of the study vaccine/placebo at Days 0 and 21 and for whom assay results for antibodies against vaccine-homologous H5N1 HA antigen for the blood samples taken at Days 0 and 182 were available||Subject|||Number
838027|NCT01310413|Secondary|Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain|"HI antibody titers against the H5N1 A/Indonesia virus strain (A/INDO) were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of higher than or equal to (>=) 1:10.
As the analyses were performed and disclosed stepwise – i.e. as soon as a study phase was completed – several releases of the CTRS (result summaries) were published. To generate an integrated Clinical Study Report, one set of domain datasets covering all analyses was used and the Adapted ATP cohort for immunogenicity has been defined. As a consequence, some of the data previously disclosed and based on ATP cohort for immunogenicity at Day 42, Day 182 and Day 385 have been replaced in this summary with data generated with the Adapted ATP cohort for immunogenicity."|At Day 42.|The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who received 2 doses of the study vaccine/placebo at Days 0 and 21 and for whom assay results for antibodies against vaccine-homologous H5N1 HA antigen for the blood samples taken at Days 0 and 42 were available.||Titer||95% Confidence Interval|Geometric Mean
838028|NCT01310413|Secondary|Number of Subjects Seroprotected as Regards Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain.|"A seroprotected subject against the a/Indonesia/5/2005 (A/INDO) virus strain was defined as a subject with H5N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (>=) the seroprotection cut-off of 1:40.
As the analyses were performed and disclosed stepwise – i.e. as soon as a study phase was completed – several releases of the CTRS (result summaries) were published. To generate an integrated Clinical Study Report, one set of domain datasets covering all analyses was used and the Adapted ATP cohort for immunogenicity has been defined. As a consequence, some of the data previously disclosed and based on ATP cohort for immunogenicity at Day 42, Day 182 and Day 385 have been replaced in this summary with data generated with the Adapted ATP cohort for immunogenicity."|At Day 0 and Day 182|Adapted ATP cohort for immunogenicity included all evaluable subjects for which Day 21 and Day 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Day 182 data were obtained from the ATP cohort for immunogenicity at Day 182, and Day 385 data were obtained from the ATP cohort for immunogenicity at Day 385.||Subject|||Number
838029|NCT01310413|Secondary|Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain.|"HI antibody titers against the H5N1 A/Indonesia virus strain (A/INDO) were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of higher than or equal to (>=) 1:10.
Adapted ATP cohort for immunogenicity included all evaluable subjects for which Day 21 and Day 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Day 182 data were obtained from the ATP cohort for immunogenicity at Day 182, and Day 385 data were obtained from the ATP cohort for immunogenicity at Day 385."|At Day 0 and Day 182.|Adapted ATP cohort for immunogenicity included all evaluable subjects for which Day 21 and Day 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Day 182 data were obtained from the ATP cohort for immunogenicity at Day 182, and Day 385 data were obtained from the ATP cohort for immunogenicity at Day 385.||Titre||95% Confidence Interval|Geometric Mean
838030|NCT01310413|Secondary|Geometric Mean Increase (GMI) for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain.|GMI also known as the seroconversion factor (SCF) or geometric mean fold rise (GMFR) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titre to the pre-vaccination reciprocal HI titre for the vaccine virus.|At Days 21 and 42|The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who received 2 doses of the study vaccine/placebo at Days 0 and 21 and for whom assay results for antibodies against vaccine-homologous H5N1 HA antigen for the blood samples taken at Days 0 and 42 were available.||Ratio||95% Confidence Interval|Geometric Mean
838031|NCT01310413|Secondary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain.|"A subject seroconverted for HI antibodies against the H5N1 A/Indonesia virus strain (A/INDO) was defined as a vaccinee with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer higher than or equal to (>=) 1:40, or with a pre-vaccination titer >= 1:10 and at least a 4-fold increase in post-vaccination titer.
As the analyses were performed and disclosed stepwise – i.e. as soon as a study phase was completed – several releases of the CTRS (result summaries) were published. To generate an integrated Clinical Study Report, one set of domain datasets covering all analyses was used and the Adapted ATP cohort for immunogenicity has been defined. As a consequence, some of the data previously disclosed and based on ATP cohort for immunogenicity at Day 42, Day 182 and Day 385 have been replaced in this summary with data generated with the Adapted ATP cohort for immunogenicity."|At Days 21 and 42|Adapted ATP cohort for immunogenicity included all evaluable subjects for which Day 21 and Day 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Day 182 data were obtained from the ATP cohort for immunogenicity at Day 182, and Day 385 data were obtained from the ATP cohort for immunogenicity at Day 385.||Subject|||Number
838032|NCT01310413|Secondary|Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain.|A seroprotected subject against the a/Indonesia/5/2005 (A/INDO) virus strain was defined as a subject with H5N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (>=) the seroprotection cut-off of 1:40.|At Days 0 and 21|The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who received 2 doses of the study vaccine/placebo at Days 0 and 21 and for whom assay results for antibodies against vaccine-homologous H5N1 HA antigen for the blood samples taken at Days 0 and 42 were available.||Subject|||Number
838033|NCT01310413|Secondary|Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain.|HI antibody titers against the H5N1 A/Indonesia virus strain (A/INDO) were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of higher than or equal to (>=) 1:10.|At Days 0 and 21|The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who received 2 doses of the study vaccine/placebo at Days 0 and 21 and for whom assay results for antibodies against vaccine-homologous H5N1 HA antigen for the blood samples taken at Days 0 and 42 were available.||Titer||95% Confidence Interval|Geometric Mean
838034|NCT01310413|Primary|Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain.|A seroprotected subject against the a/Indonesia/5/2005 (A/INDO) virus strain was defined as a subject with H5N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (>=) the seroprotection cut-off of 1:40.|At Day 42.|The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who received 2 doses of the study vaccine/placebo at Days 0 and 21 and for whom assay results for antibodies against vaccine-homologous H5N1 HA antigen for the blood samples taken at Days 0 and 42 were available.||Subject|||Number
838035|NCT01310582|Secondary|Time to Discharge From PACU||At 30-45 minutes, following discontinuation of volatile anesthetic at the end of surgery and transfer to PACU|||Minutes||Standard Deviation|Mean
838036|NCT01310582|Primary|Time to Opening of Eyes||At 30-45 minutes, following discontinuation of volatile anesthetic at the end of surgery|||seconds||Standard Deviation|Mean
838037|NCT01310699|Secondary|Percentage of Nonpolypoid (Flat) Missed Lesions|Compare the number of missed non-polypoid lesions on the index examination using the new high definition narrow band imaging colonoscopy to the conventional high definition white light mode colonoscopy.|One week (time of procedure plus time for pathology of polyp to be analyzed by histology)|Adenoma by shape (i.e. Flat)||percentage of adenomas|||Number
838038|NCT01310699|Secondary|Percentage of Missed Lesions on Index Colonoscopy.|Compare the number of missed lesions on the index examination using the new high definition narrow band imaging colonoscopy to the conventional high definition white light mode colonoscopy, based on the tandem colonoscopy findings.|One week (time of procedure plus time for pathology of polyp to be analyzed by histology)|||percentage of adenomas|||Number
838039|NCT01310699|Primary|Number of Participants With Nonpolypoid (Flat and Depressed) Colorectal Neoplasm|Compare the nonpolypoid colorectal neoplasm detection characteristics of the new high definition narrow band imaging colonoscopy to conventional high definition white light mode colonoscopy.|One week (time of procedure plus time for pathology of polyp to be analyzed by histology)|||Participants|||Count of Participants
838094|NCT01311661|Secondary|Mean Pre-dose Evening PEF (PEF p.m.)|PEF p.m. was measured by patients at home using the AM3 device (overall means obtained during each period of randomised treatment will be compared). Means are adjusted for treatment, period, patient and study baseline.|0-3 weeks|FAS||Liter/min||Standard Error|Mean
838040|NCT01310777|Primary|Mean Diurnal IOP Change From Baseline at Month 3|Mean Diurnal IOP Change from Baseline at Month 3 (ie, the subject IOP change from baseline averaged over the 9 AM, + 2 h, and + 7 h time points at Month 3) was measured by Goldmann applanation tonometry. The study drug was instilled approximately 15 minutes after conducting the 9AM IOP measurement. One eye from each subject was chosen as the study eye, and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).|Baseline (Day 1), Month 3|The intent-to-treat (ITT) analysis set included all subjects who received study drug and completed at least 1 scheduled on-therapy study visit.||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
838041|NCT01310803|Secondary|To Evaluate the Safety and Tolerability of Maintenance Therapy With Valrubicin After Induction With Valrubicin, as Compared to Induction With Valrubicin Only in Subjects With CIS of the Bladder|The occurrence of serious adverse events (SAEs), occurrence of local adverse reactions (LARs), results of vital signs, physical exams and laboratory test, and study discontinuation due to inability to complete valrubicin instillations|2 years|No analysis completed due to limited enrollment (1 subject) prior to study termination.|||||
838042|NCT01310803|Primary|To Evaluate the Efficacy of Maintenance Therapy With Valrubicin After Induction With Valrubicin, as Compared to Induction With Valrubicin Only in Subjects With CIS of the Bladder.|time interval from randomization to an event. An event is defined as tumor recurrence (any stage or grade), tumor progression to muscle-invasive bladder cancer (MIBC), metastatic bladder cancer or death from any cause, whichever occurs first. Tumor recurrence or progression must be documented by biopsy/transurethral resection of bladder tumor (TURBT).|2 years|No analysis completed due to limited enrollment (1 subject) prior to study termination.|||||
838043|NCT01310855|Secondary|Safety and Tolerability||from date of randomisation to death||||||
838044|NCT01310855|Secondary|Time to Deterioration of Neurological Status||from date of randomization to the date of first neurological status worsening in comparison to baseline (first of 2 confirmatory reports at 2 consecutive visits, 6 weeks apart) as assessed by the clinician, or until date of death, whichever is first.||||||
838045|NCT01310855|Secondary|Steroid Use||from randomization to first increase in dexamethasone dose||||||
838046|NCT01310855|Secondary|Progression-free Survival Rate at 6 Months||from the date of randomisation to 6 months||||||
838047|NCT01310855|Secondary|Radiographic Response Rate||from baseline scan to six week and 12 week scans||||||
838048|NCT01310855|Secondary|Overall Survival||from date of randomization to date of Death due to any cause.||||||
838049|NCT01310855|Primary|Progression-free Survival|"Progression free survival (PFS) defined as the time from the date of randomisation to the date of first progression or death due to any cause, whichever one comes first.
The progression definition will be based on modified RANO criteria (Wen 2010), such that progression will be defined as the earliest time that at least one of the following occurs:
Clinical deterioration
Failure to return for evaluation as a result of death or deteriorating condition
Or, by retrospective radiographic central review:
Any new lesion
Increase in ≥25% of sum of the products of perpendicular diameters of enhancing lesions compared with baseline scan, on stable or increasing doses of steroids (dexamethasone) compared to baseline (T1 post-contrast scan)
Clear progression of non-measureable disease
Significant increase in T2/FLAIR non-enhancing lesion – on stable or increasing steroids (dexamethasone) compared with baseline or best response not caused by co-morbid events."|from the date of randomisation to the date of first progression or death due to any cause, until 6 months from the date the last patient finished trial treatment (the day after the date that the last trial drug was taken)|||months||90% Confidence Interval|Median
838050|NCT01310868|Secondary|Survival at 24 Months||from the date of surgery to 24 months|Patients receiving 5-ala and carmustine wafers during surgical resection for glioblastoma multiforme that was confirmed peri/post-operatively||months||95% Confidence Interval|Median
838051|NCT01310868|Secondary|Time to Clinical Progression||from the date of surgery to the date of the first MRI scan fitting the criteria for progression, or the date the clinical detrioration or death was first reported|Patients receiving 5-ala and carmustine wafers during surgical resection for glioblastoma multiforme that was confirmed peri/post-operatively||months||95% Confidence Interval|Median
838052|NCT01310868|Primary|Safety, Tolerability, and Feasibility of Combination Intra-operative 5-ALA and Gliadel Wafers Prior to Adjuvant Radiotherapy Plus Temozolomide|"Procedure compliance: Proportion of 5-ALA resected patients who received Carmustine wafer implants (e.g to take into account rates of patients who did not receive Carmustine wafer implants due to 1) ventricular breach, 2) inaccurate peri-operative diagnosis, 3) intra-operative surgical decision)
Post-operative complication rate: Proportion of patients with a new post-operative deficit or surgical complication (wound infection, CSF leakage, intracranial hypertension)
No. of patients with chemoRT delay (i.e number who do not begin chemoRT 6 weeks after surgery) due to surgical complications*
No. of patients failing to start chemoRT due to surgical complications rather than tumour progression
No. of patients failing to complete chemoRT without interruption (RT with concomitant chemotherapy, and RT with concomitant plus adjuvant chemotherapy)
Proportion of patients with a lower WHO performance status after surgery with Carmustine wafers (at first post-operative clinic visit)"|Date of surgery to end of temozolomide and radiotherapy treatment (up to 34 weeks)|of 72 patients recruited, 62 received 5-ALA and carmustine wafers. Of these 62 patients, 59 were found to be eligible and included in the final analysis||Participants|||Count of Participants
838060|NCT01311102|Primary|Pain During IUD Placement|"IUD was inserted following the manufacturer's instructions, and a pain score was immediately obtained. Pain was scored on 0-9 scale; with 0 being no pain and 9 being worst pain in life."|Immediately after IUD placement|||units on a scale of 0-9||Standard Deviation|Mean
838061|NCT01311102|Primary|Pain Measurement During Liquid Infusion/Sounding|"After liquid infused into three parts of the endometrial cavity: in the lower one third, the middle, and at the top of the cavity. Pain was scored on a 0-9 scale; with 0 being no pain and 9 being worst pain in life."|Recorded at the end of the infusion|||units on a scale of 0-9||Standard Deviation|Mean
838062|NCT01311102|Primary|Pain During Tenaculum Placement|"Pain score on 0-9 scale for tenaculum placement (without anesthesia); with 0 being no pain and 9 being worst pain in life. Taken to adjust for different pain thresholds among subjects"|Immediately following tenaculum placement|||units on a scale of 0-9||Standard Deviation|Mean
838063|NCT01311102|Primary|Pain Scores During Overall IUD Placement|"Pain score on 0-9 scale obtained just before the patient left the examination room; with 0 being no pain and 9 being worst pain in life."|Before patient left the examination room at conclusion of procedure|||units on a scale of 0-9||Standard Deviation|Mean
838064|NCT01311362|Primary|Cmax of Ambrisentan||after first dose, at steady-state and during St John's wort|||ng/ml||95% Confidence Interval|Geometric Mean
838065|NCT01311362|Primary|AUC of Ambrisentan||after first dose, at steady-state, during St John's wort|||h*ng/ml||95% Confidence Interval|Geometric Mean
838066|NCT01311505|Other Pre-specified|Number of Participants With Adverse Events (AEs)|Any untoward medical occurrence in a participant who received study treatment was considered an AE without regard to possibility of causal relationship.|Baseline (Day 0), Day 1 and Follow-up (1 week post-baseline)|Safety population included participants who received at least 1 dose of study medication.||participants|||Number
838067|NCT01311505|Other Pre-specified|Clinically Significant Change From Baseline Respiratory Rate|Mean change: vital sign value at observation (Day 1 and follow-up) minus vital sign value at baseline.|Baseline (Day 0), Day 1 (Hour 10), and follow-up (1 week post-baseline)|Data was not summarized since respiratory rate remained within normal limits throughout the study and there were no significant deviations from baseline.||respirations/minute||Standard Deviation|Mean
838068|NCT01311505|Other Pre-specified|Clinically Significant Change From Baseline Oral Temperature|Mean change: vital sign value at observation (Day 1 and follow-up) minus vital sign value at baseline.|Baseline (Day 0), Day 1 (Hour 10), and follow-up (1 week post-baseline)|Data was not summarized since oral temperature remained within normal limits throughout the study and there were no significant deviations from baseline.||Degrees Celsius||Standard Deviation|Mean
838069|NCT01311505|Other Pre-specified|Clinically Significant Change From Baseline Pulse Rate|Mean change: vital sign value at observation (Day 1 and follow-up) minus vital sign value at baseline.|Baseline (Day 0), Day 1 (Hour 10), and follow-up (1 week post-baseline)|Data was not summarized since pulse rate remained within normal limits throughout the study and there were no significant deviations from baseline.||beats per minute||Standard Deviation|Mean
838070|NCT01311505|Other Pre-specified|Clinically Significant Change From Baseline Supine Blood Pressure (BP)|Mean change: vital sign value at observation (Day 1 and follow-up) minus vital sign value at baseline.|Baseline (Day 0), Day 1 (Hour 10), and follow-up (1 week post-baseline)|Data was not summarized since supine systolic and diastolic BP remained within normal limits throughout the study and there were no significant deviations from baseline.||millimeters of mercury (mmHg)||Standard Deviation|Mean
838071|NCT01311505|Other Pre-specified|Number of Participants With Abnormal Safety Laboratory Test Values|Participants were evaluated for following safety laboratory tests: Hematology, chemistry, urinalysis.|Screening and Follow-up (1 week post-baseline)|Safety population included participants who received at least 1 dose of study medication.||participants|||Number
838072|NCT01311505|Secondary|Extrapolated Area Under the Curve (AUC Percent [%] Extrapolated)|AUC%extrapolated is the extrapolated area under the plasma concentration time profile following the last measured concentration. It is calculated as (AUC [0-∞] minus AUC[0-10])*100/ AUC (0-∞), where AUC (0-∞) = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-∞) and AUC(0-10) = area under the plasma concentration time-curve from zero (pre-dose) to the last quantifiable concentration.|0 (pre-dose), 1, 2, 3, 4, 6, 8 and 10 hrs post-dose|PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||Percent AUC||Geometric Coefficient of Variation|Geometric Mean
838073|NCT01311505|Secondary|Plasma Decay Half-life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 1, 2, 3, 4, 6, 8 and 10 hrs post-dose|PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||hrs||Standard Deviation|Mean
838074|NCT01311505|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0-∞])|AUC (0-∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|0 (pre-dose), 1, 2, 3, 4, 6, 8 and 10 hrs post-dose|PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||mcg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
838075|NCT01311505|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 (pre-dose), 1, 2, 3, 4, 6, 8 and 10 hrs post-dose|PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||hrs||Full Range|Median
838076|NCT01311505|Primary|Maximum Observed Plasma Concentration (Cmax)||0 (pre-dose), 1, 2, 3, 4, 6, 8 and 10 hrs post-dose|PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
838077|NCT01311505|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC [0-t])|AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)|0 (pre-dose), 1, 2, 3, 4, 6, 8 and 10 hours (hrs) post-dose|Pharmacokinetic (PK) parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||microgram*hour/milliliter (mcg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
838078|NCT01311557|Secondary|Percentage of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Injection With a Single Dose of Adacel Vaccine|Solicited injection-site: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever, Headache, Malaise, and Myalgia. Grade 3 Solicited Injection-site reactions: Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥50 mm. Grade 3 Solicited systemic reactions: Fever, ≥39.0˚C or ≥102.1˚F; Headache, Malaise, and Myalgia Significant, prevents daily activity.|Day 0 up to Day 7 post-vaccination|Solicited injection site and systemic reactions were assessed in the Safety Analysis Set.||Percentage of participants|||Number
838079|NCT01311557|Secondary|Summary of Anti-Pertussis Geometric Means of Titers Before and Post-Vaccination With a Single Dose of Adacel Vaccine|Anti-Pertussis titers (Pertussis toxoid [PT], Filamentous hemagglutinin [FHA], Pertactin [PRN], Fimbriae types 2 and 3 [FIM]) geometric mean titers were assessed by enzyme linked immunosorbent assay (ELISA).|Day 0 (pre-vaccination) and Day 30 post-vaccination|Geometric mean titers were assessed in the Per Protocol Analysis Set.||Titers (1/dilutions)||95% Confidence Interval|Geometric Mean
838080|NCT01311557|Secondary|Percentage of Participants With Seroprotection to Tetanus and Diphtheria Following a Single Dose of Adacel Vaccine|Anti-tetanus seroprotection rates were assessed by enzyme-linked immunosorbent assay (ELISA). Anti-diphtheria seroprotection was assessed by a toxin neutralization test. Seroprotection was defined as post-vaccination antibody titers ≥0.1 IU/mL.|Day 0 (pre-vaccination) and 30 days post-vaccination|Seroprotection rates were assessed in the Per Protocol Analysis Set.||Percentage of participants|||Number
838081|NCT01311557|Primary|Summary of Anti-Tetanus and Anti-Diphtheria Booster Response Following a Booster Dose of Adacel® Vaccine|Anti-tetanus booster responses were assessed by enzyme-linked immunosorbent assay (ELISA). Anti-diphtheria booster responses were assessed by a toxin neutralization test. Booster response rate was defined as a four-fold increase in pre- to post-vaccination for subjects with pre-vaccination titers ≤ 2.56 EU/mL for diphtheria and ≤ 2.7 EU/mL for tetanus. If the pre-vaccination titers were > 2.56 EU/mL for diphtheria or > 2.7 EU/mL for tetanus, then a two-fold increase in response rate was defined as a booster response.|30 days post-vaccination|Anti-Tetanus and anti-Diphtheria booster responses were assessed in the Per-protocol Analysis Set.||Percentage of participants|||Number
838082|NCT01311557|Primary|Summary of Anti-Pertussis Booster Response Following a Booster Dose of Adacel® Vaccine|Anti-Pertussis booster responses were assessed by enzyme linked immunosorbent assay (ELISA). For pertussis antigens (Pertussis toxoid [PT], filamentous hemagglutinin [FHA], pertactin [PRN], fimbriae types 2 and 3 [FIM]), a booster response rate was defined as a four-fold increase in pre- to post-vaccination titers for participants with pre vaccination titers ≤ 93 ELISA Unit (EU)/mL for PT, ≤ 170 EU/mL for FHA, ≤ 115 EU mL for PRN, and ≤ 285 EU/mL for FIM. If the pre-vaccination titers were > 93 EU/mL for PT, > 170 EU/mL for FHA, > 115 EU mL for PRN, or > 285 EU/mL for FIM then a two-fold increase in the antibody titer was defined as a booster response.|30 days post-vaccination|Anti-pertussis booster response were assessed in the Per-protocol Analysis Set.||Percentage of participants|||Number
838083|NCT01311557|Primary|Summary of Geometric Mean Titers of Anti-Pertussis Titers Following a Single Dose of Adacel® Vaccine|Anti-Pertussis titers (Pertussis toxoid [PT], Filamentous hemagglutinin [FHA], Pertactin [PRN], Fimbriae types 2 and 3 [FIM]) geometric mean titers were assessed by enzyme-linked immunosorbent assay (ELISA).|Day 30 post-vaccination|Geometric mean titers were assessed in the Per-protocol Analysis Set.||Titers (1/dilutions)||95% Confidence Interval|Geometric Mean
838084|NCT01311661|Secondary|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG|Clinical relevant abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events. Time frame for adverse event reporting includes 12 days into the subsequent washout or post-treatment period.|3 weeks + 12 days|Treated set||Participants|||Number
838085|NCT01311661|Secondary|Total Asthma Control Questionnaire (ACQ) Score|Control of asthma as assessed by the ACQ at the end of each 3-week treatment period.The ACQ contains 7 questions, each question has a 7 point scale from 0 (no symptoms) till 6 (highest intensity). Total score was defined as the sum of all items divided by the number of items.|3 weeks|FAS||Units on a scale||Standard Error|Mean
838086|NCT01311661|Secondary|Number of Patients Categorized by Worst Asthma Nighttime Symptoms (Overall)|Assessed by patients at home using the AM3 device during each period of randomised treatment.|0-3 weeks|FAS||Number of patients|||Number
838087|NCT01311661|Secondary|Number of Patients Categorized by Worst Asthma Daytime Symptoms (Overall)|Assessed by patients at home using the AM3 device during each period of randomised treatment .|0-3 weeks|FAS||Number of patients|||Number
838088|NCT01311661|Secondary|Number of Patients Categorized by Highest Number of Night Time Awakenings (Overall)|Assessed by patients at home using the AM3 device during each period of randomised treatment.|0-3 weeks|FAS||Number of patients|||Number
838089|NCT01311661|Secondary|Percentage of Asthma Symptom Free Days|Percentage of asthma-symptom free days of each treatment period was calculated as the number of symptom-free days divided by the number of days on treatment multiplied by 100. A symptom-free day was defined as a day in which no asthma symptoms were recorded, no rescue medication was recorded, activities during the day were not at all limited due to asthma, no shortness of breath during the day was recorded, no wheezing or coughing during the day and no night-time awakenings due to asthma were recorded. Assessed by patients at home using the AM3 device.|0-3 weeks|FAS||Percentage of asthma symptom free days||Standard Error|Mean
838090|NCT01311661|Secondary|Mean Number of Puffs of Rescue Medication During the Whole Day|Mean of daily use of salbutamol (albuterol) rescue medication as needed during the entire study period. Assessed by patients at home using the AM3 device (overall mean number obtained during each period of randomised treatment will be compared). Means are adjusted for treatment, period, patient and study baseline.|0-3 weeks|FAS||Puffs||Standard Error|Mean
838096|NCT01311661|Secondary|Trough PEF Response|Response was defined as change from baseline. Study baseline PEF was defined as the mean of the available pre-dose PEF values at the randomisation visit. Trough values were defined as the mean of 2 PEF values performed at 23 h and 23 h 50 min after the last morning trial drug inhalation at the end of each 3 week period of randomised treatment. Means are adjusted for treatment, period, patient and study baseline.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 23 h, and 23 h 50 min related to morning dose after 3 weeks|FAS||Liter/sec||Standard Error|Mean
838097|NCT01311661|Secondary|Peak PEF Within 24 Hours Post-dose Response|Response was defined as change from baseline. Study baseline PEF was defined as the mean of the available pre-dose PEF values at the randomisation visit. Peak PEF within 24 hours post dose measured following the morning trial drug inhalation at the end of each 3 week period of randomised treatment. Means are adjusted for treatment, period, patient and study baseline.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 30 min, 60 min, 2 h, 3 h, 4 h, 6 h, 8h, 10 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min related to morning dose after 3 weeks|FAS||Liter/sec||Standard Error|Mean
838098|NCT01311661|Secondary|Peak Expiratory Flow (PEF) Area Under Curve 0-24 Hours (AUC 0-24h) Response|Response was defined as change from baseline. Study baseline PEF was defined as the mean of the available pre-dose PEF values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. PEF AUC 0-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres/seconds.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 mins, 30 min, 60 min, 2 h, 3 h, 4 h, 6 h, 8h, 10 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min related to morning dose after 3 weeks|FAS||Liter/sec||Standard Error|Mean
838099|NCT01311661|Secondary|PEF Area Under Curve 12-24 Hours (AUC 12-24h) Response|Response was defined as change from baseline. Study baseline PEF was defined as the mean of the available pre-dose PEF values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. PEF AUC 12-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres/seconds.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 11 h 50 min, 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min related to morning dose after 3 weeks|FAS||Liter/sec||Standard Error|Mean
838100|NCT01311661|Secondary|Peak Expiratory Flow (PEF) Area Under Curve 0-12 Hours (AUC 0-12h) Response|Response was defined as change from baseline. Study baseline PEF was defined as the mean of the available pre-dose PEF values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. PEF AUC 0-12h was calculated using the trapezoidal rule, divided by the observation time to report in litres/seconds.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 mins, 30 min, 60 min, 2 h, 3 h, 4 h, 6 h, 8h, 10 h, 11 h 50 min related to morning dose after 3 weeks|FAS||Liter/sec||Standard Error|Mean
838101|NCT01311661|Secondary|Trough FVC Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Trough values were defined as the mean of 2 FVC values performed at 23 h and 23 h 50 min after the last morning trial drug inhalation at the end of each 3 week period of randomised treatment. Means are adjusted for treatment, period, patient and study baseline.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 23 h, and 23 h 50 min related to morning dose after 3 weeks|FAS||Liter||Standard Error|Mean
838102|NCT01311661|Secondary|Peak FVC Within 24 Hours Post-dose Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Peak FVC within 24 hours post-dose measured following the morning trial drug inhalation at the end of each 3 week period of randomised treatment. Means are adjusted for treatment, period, patient and study baseline.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 30 min, 60 min, 2 h, 3 h, 4 h, 6 h, 8h, 10 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min related to morning dose after 3 weeks|FAS||Liter||Standard Error|Mean
838103|NCT01311661|Secondary|FVC Area Under Curve 0-24 Hours (AUC 0-24h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FVC AUC 0-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 mins, 30 min, 60 min, 2 h, 3 h, 4 h, 6 h, 8h, 10 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min related to morning dose after 3 weeks|FAS||Liter||Standard Error|Mean
838104|NCT01311661|Secondary|FVC Area Under Curve 12-24 Hours (AUC 12-24h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FVC AUC 12-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 11 h 50 min, 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min related to morning dose after 3 weeks|FAS||Liter||Standard Error|Mean
838105|NCT01311661|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-12 Hours (AUC 0-12h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FVC AUC 0-12h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 mins, 30 min, 60 min, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 11 h 50 min related to morning dose after 3 weeks|FAS||Liter||Standard Error|Mean
838106|NCT01311661|Secondary|Trough FEV1 Response|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Trough values were defined as the mean of 2 FEV1 values performed at 23 h and 23 h 50 min after the last morning trial drug inhalation at the end of each 3 week period of randomised treatment. Means are adjusted for treatment, period, patient and study baseline.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 23 h, and 23 h 50 min related to morning dose after 3 weeks|FAS||Liter||Standard Error|Mean
838708|NCT01320683|Secondary|Overall Survival|Overall Survival is calculated for all patients from the date of initial treatment to date of death due to any cause. Patients who were still alive were censored at the date of last follow-up. Survival rates were estimates using the Kaplan-Meier method, and 95% confidence limits calculated for these estimates.|Up to 5 years||||||
838107|NCT01311661|Secondary|Peak FEV1 Within 24 Hours Post-dose Response|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Peak FEV1 within 24 hours post dose measured following the morning trial drug inhalation at the end of each 3 week period of randomised treatment. Means are adjusted for treatment, period, patient and study baseline.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 30 min, 60 min, 2 h, 3 h, 4 h, 6 h, 8h, 10 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min related to morning dose after 3 weeks|FAS||Liter||Standard Error|Mean
838108|NCT01311661|Secondary|FEV1 Area Under Curve 12-24 Hours (AUC 12-24h) Response at the End of Each Treatment Period|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FEV1 AUC 12-24h was calculated from 12-24 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 11 h 50 min, 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min related to morning dose after 3 weeks|FAS||Liter||Standard Error|Mean
838109|NCT01311661|Secondary|FEV1 Area Under Curve 0-12 Hours (AUC 0-12h) Response at the End of Each Treatment Period|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FEV1 AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 mins, 30 min, 60 min, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 11 h 50 min related to morning dose after 3 weeks|FAS||Liter||Standard Error|Mean
838110|NCT01311661|Primary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-24 Hours (AUC 0-24h) Response at the End of Each Treatment Period|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FEV1 AUC 0-24h was calculated from 0-24 hours post-dose using the trapezoidal rule, divided by the observation time (24h) to report in litres.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 mins, 30 min, 60 min, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min related to morning dose after 3 weeks|Full analysis set (FAS). FAS is defined as all patients in the treated set for whom the baseline (pre-dose) value is available, and who have a value for the primary endpoint for at least one crossover period.||Liter||Standard Error|Mean
838134|NCT01312038|Primary|Fraction of Middle Ear (ME) Pressure Equilibrated (FGE)|The proportion of the pressure chamber-ME pressure gradient equilibrated with 1 swallow|After achieving the desired ME-pressure chamber gradient at baseline and 30 min post treatment|ears pre-treatment/ears post-treatment||ratio|Participants|Standard Deviation|Mean
838135|NCT01305564|Secondary|Filter Penetration >3mm at Retrieval||Pre-retrieval|The denominator of 124 is equal to the number of subjects undergoing a retrieval procedure with imaging to confirm penetration.||percentage of participants||95% Confidence Interval|Number
838136|NCT01305564|Secondary|Filter Penetration >3mm at Placement||Post-placement|Penetration at Placement was measured immediately post-placement but prior to retrieval.||percentage of participants||95% Confidence Interval|Number
838137|NCT01305564|Secondary|Filter Tilt at Retrieval|Rate of filter indwell complications of: tilt >15°|Pre-retrieval imaging|All patients undergoing a retrieval procedure.||percentage of participants||95% Confidence Interval|Number
838138|NCT01305564|Secondary|Filter Tilt at Placement|Rate of filter indwell complications of: tilt >15°|Post-placement imaging|Tilt was measured post-placement with vena cavagram.||percentage of participants||95% Confidence Interval|Number
838139|NCT01305564|Secondary|Filter Migration|Rate of filter indwell complications of: migration >2cm.|6 months|The denominator of 186 is equal to the number of subjects that completed a 6 month follow-up or had their filter retrieved, with imaging completed to confirm lack of migration.||percentage of participants||95% Confidence Interval|Number
838140|NCT01305564|Secondary|Filter Fracture|Rate of filter fracture|6 months|The denominator of 186 is equal to the number of subjects that completed a 6 month follow-up or had their filter retrieved, with imaging completed to confirm lack of fracture.||percentage of participants||95% Confidence Interval|Number
838141|NCT01305564|Secondary|Rate of New or Worsening Deep Vein Thrombosis|Rate of new or worsening Deep Vein Thrombosis (DVT) from placement to the six month follow-up. Worsening DVT is defined as an extension of existing DVT to a new venous segment on ultrasound in patients that had DVT at the baseline visit.|6 months|The denominator of 188 is equal to the number of subjects completing the 6 month visit or with a filter retrieval procedure.||percentage of participants||95% Confidence Interval|Number
838142|NCT01305564|Secondary|Rate of Recurring Pulmonary Embolism|Rate of recurrent Pulmonary Embolism while the filter is indwelling or one month post-retrieval.|24 months|||percentage of participants||95% Confidence Interval|Number
838143|NCT01305564|Primary|Clinical Success of Retrieval|Clinical success for retrieval is defined as successful technical retrieval of the filter without retrieval complications requiring intervention. Only the 121 successful retrievals are counted here.|24 months|||percentage of participants||95% Confidence Interval|Number
838144|NCT01305564|Primary|Technical Success of Retrieval|Technical success for retrieval is defined as retrieval of the filter such that the entire filter is retrieved intact.|24 months|The denominator of 124 is equal to the number of subjects that had a filter retrieval procedure (successful and unsuccessful retrievals). Subjects were not required to have a retrieval procedure.||percentage of participants||95% Confidence Interval|Number
838145|NCT01305564|Primary|Clinical Success of Placement|Is the one-sided lower limit of the 95% confidence interval for the observed clinical success rate at least 80%? Clinical success of filter placement is defined as freedom from subsequent Pulmonary Embolism (PE), filter embolization, caval occlusion, filter and procedure related death, insertion adverse events (AEs), and technical failure of placement.|6 months|The denominator of 189 is equal to all of the subjects that completed the 6 month visit, had their filter retrieved, or experienced a component of the clinical success of placement endpoint regardless of follow-up duration.||percentage of participants||95% Confidence Interval|Number
838146|NCT01305564|Primary|Technical Success of Placement|Technical success of filter placement is defined as the deployment of the filter such that the physician judges the location to be suitable to provide sufficient mechanical protection against Pulmonary Embolism.|6 months|||percentage of participants||95% Confidence Interval|Number
838149|NCT01305577|Secondary|Change From Baseline in Self-rating of Attractiveness|"Self-rating of attractiveness assesses aspects of appearance from the participant's perspective by a series of 6 questions:
How attractive do you think your overall appearance (chin/neck, eyes, nose, mouth, entire face) is/are?” Each question was answered on a scale from 1 to 9 where 1 = Not at all attractive, 5 = Neither attractive nor unattractive and 9 = Extremely attractive.
A positive change from Baseline indicates improvement."|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)|Intent-to-treat population with available data||units on a scale||Standard Deviation|Mean
838150|NCT01305577|Secondary|Change From Baseline in Patient-Reported Submental Fat Impact Scale (PR-SMFIS)|The PR-SMFIS assesses the impact of submental fat on self-perception of 6 characteristics related to the appearance of submental fullness as evaluated by the participant. Each item is rated on an 11-point numeric scale from 0 to 10.|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)||01/2016||||
838151|NCT01305577|Secondary|Change From Baseline in Patient-reported Submental Fat Rating Scale (PR-SMFRS)|"The PR-SMFRS is based on the participant's response to the question How much fat do you currently have under your chin? answered on a 5-point ordinal scale (0-4) with 0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat. Improvement is defined as any decrease in score and worsened as any increase in score."|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)|Intent-to-treat population with available data||percentage of participants|||Number
838152|NCT01305577|Secondary|Change From Baseline in Submental Fat Thickness|Submental thickness was measured using caliper devices.|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)|Intent-to-treat population with available data||mm||Standard Deviation|Mean
838153|NCT01305577|Secondary|Change From Baseline in SSRS Scores|"The SSRS assesses participant's satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6: where 0 = Extremely dissatisfied, 1 = Dissatisfied, 2 = Slightly dissatisfied, 3 = Neither satisfied nor dissatisfied, 4 = Slightly satisfied, 5 = Satisfied and 6 = Extremely satisfied.
A positive change from Baseline indicates improvement."|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)|Intent-to-treat population with available data||units on a scale||Standard Deviation|Mean
838154|NCT01305577|Secondary|Change From Baseline in CR-SMFRS Scores|"The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.
A negative change from Baseline indicates improvement."|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)|Intent-to-treat population with available data||units on a scale||Standard Deviation|Mean
838155|NCT01305577|Primary|Percentage of Participants With a Subject Self Rating Scale (SSRS) Response|"A SSRS response is defined as an SSRS score that is 4 or greater 12 weeks after the last treatment.
The SSRS assesses participant's satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6: where 0 = Extremely dissatisfied, 1 = Dissatisfied, 2 = Slightly dissatisfied, 3 = Neither satisfied nor dissatisfied, 4 = Slightly satisfied, 5 = Satisfied and 6 = Extremely satisfied."|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)|Intent-to-treat population; LOCF method was used to impute missing data||percentage of participants|||Number
838156|NCT01305577|Secondary|Percentage of Participants With a CR-SMFRS 2-grade Response|"A CR-SMFRS 2-grade response is defined as at least a 2-point improvement (i.e. 2-point reduction) from Baseline 12 weeks after the last treatment.
The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme."|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)|Intent-to-treat population; LOCF method was used to impute missing data||percentage of participants|||Number
838157|NCT01305577|Primary|Percentage of Participants With a Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) 1-grade Response|"A CR-SMFRS response is defined as at least a 1-point improvement (i.e. 1-point reduction) from Baseline 12 weeks after the last treatment.
The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme."|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)|Intent-to-treat (ITT) population, which consisted of all randomized participants who had at least one efficacy assessment (CR-SMFRS or Subject Self Rating Scale) at Baseline. Last observation carried forward (LOCF) method was used to impute missing data.||percentage of participants|||Number
838158|NCT01305655|Secondary|Evaluate Time at Hospital and Health Costs||6 years 6 months||01/2017||||
838159|NCT01305655|Primary|Number of Participants With Adverse Event to HD-MTX Treatment in NOPHO ALL-2008 as a Measure of Toxic Mtx Concentrations in Blood, Nephrotoxicity, Hepatotoxicity, Mucositis, MTX Elimination Time and Permanent Kidney Damage.|"Glucarpidase was used in case of predefined toxic MTX values at defined time points and/or in combination with decreased renal function.
A total of 47 patients of the 1286 ALL-patients included in the protocol (3.7 %) were treated with Glucarpidase."|6 years 6 months|||participants|||Number
838160|NCT01305772|Secondary|Nine (9) Month Overall Survival (OS)|Overall survival (OS) was defined as from the time of enrollment to the date of death resulting from any cause. Time as censored at the date of the last follow-up visit for subjects who were still alive. The 9-month OS rate is a percentage, representing the fraction of treated subjects who, after 9 months, are alive.|9 months|||percentage of treated patients surviving||95% Confidence Interval|Number
838161|NCT01305772|Secondary|Nine (9) Month Progression Free Survival (PFS)|"Nine month progression-free survival (PFS) was defined from the time from enrollment to the first date of disease progression or death as a result of any cause. Progression was defined in the same manner as in RECIST 1.1: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5mm (the appearance of one or more new lesions is also considered progression).
Time was censored at the date of the last follow-up visit for subjects who were still alive and have not progressed. The 9 month PFS rate is a percentage, representing the fraction of treated subjects who, after 9 months, are disease free or alive."|9 months|||percentage of treated patients||95% Confidence Interval|Number
838735|NCT01320826|Secondary|Colonoscopy Procedure Time|Colonoscopic procedural time will be defined as the time from the first insertion of the colonoscope until it is removed from the anus.|At time of colonoscopy (DAY 1 of study)|||minutes||95% Confidence Interval|Mean
838162|NCT01305772|Primary|Change in Tumor (Primary Tumor and Lymph Node) Response and Progression Between Pre- and Post- Panitumumab Therapy|"The aim of this outcome measure was to identify a gene expression signature that predicts response to panitumumab in untreated locally advanced squamous cell cancer of the head / neck (SCCHN). Response and progression were evaluated using the largest percentage change among the cases: 1) Pre-panitumumab PET scan activity, and/or; 2) Pre-panitumumab radiologic measurement compared to post-panitumumab measurement and/or; 3) Pre-panitumumab direct measurement of tumor / lymph node compared to post-panitumumab direct measurement of tumor / lymph node. Response and progression were evaluated in this single study using the criteria changes in only the largest diameter (unidimensional measurement) of the tumor lesions were defined in the same manner as in RECIST 1.1.
No results are reported as only 2 of the 6 subjects had fresh tissue collected after the first dose of panitumumab. The study was amended to remove the biopsy procedure due to the potential risk for the participants."|Baseline to 2 years|No results will be reported for the primary outcome measure as only 2 of the 6 subjects had tissue collected after the first dose of panitumumab due to safety risk to the subject.|||||
838163|NCT01305811|Other Pre-specified|SF-36P|Ten items addressing physical functioning which are part of a short-form health survey with 36 questions. Scores range between 0 and 100 with higher scores indicating better function.|2 months|||units on a scale||Standard Deviation|Mean
838164|NCT01305811|Primary|SF-36P|Ten items addressing physical functioning which are part of a short-form health survey with 36 questions. Scores range between 0 and 100 with higher scores indicating better function.|6 months|||units on a scale||95% Confidence Interval|Mean
838165|NCT01306032|Secondary|Number of Participants With Deleterious Mutations in DNA Repair Genes|Gene expression profiling was performed in archival tumor tissue for a panel of 211 genes using deoxyribonucleic acid (DNA) array to determine deleterious mutations (i.e. nonsynonymous mutations at coding regions) of genes. Sequences were mapped to human genome reference hg19. Variants were identified with VarScan, annotated with AVIA, and masked to the exonic or exonic:splicing regions of the 211 interrogated DNA repair genes, with nonsynonymous/frameshift/stop-gain/stop-loss variants that have a population frequency of 1% or less in either 1000G (2014_04) or the ExomeSequencingProject (ESP6500si_all) with a minimum variant frequency of 10% and at least 20 reads. Lastly, variants were manually inspected for known platform and mapping errors.|Optional tumor biopsies were performed prior to start of treatment (baseline) and 6 months|Patients with sufficient tumor content in archival tissue (defined as ≥70% tumor after macrodissection) were analyzed for genetic alterations in DNA repair genes by whole-exome sequencing.||Participants|||Count of Participants
838166|NCT01306032|Secondary|Change in ϓH2AX- Positive Circulating Tumor Cells (CTCs) in Whole Blood|Number of CTCs (evaluable defined as ≥ 6 CTCs) were measured in whole blood during the course of treatment to determine drug-induced deoxyribonucleic acid damage in tumor cells.|At baseline (t=0h) and 24h post drug administration (t=24h)|Patients with sufficient CTC counts (defined as ≥6 total CTCs) pre- and post-drug administration were analyzed.||ϓH2AX- Positive CTCs||Full Range|Mean
838167|NCT01306032|Secondary|Change in Poly-ADP Ribose (PAR) Concentration Levels From Baseline|PAR levels (in pg/μg protein) were assessed in peripheral blood mononuclear cells (PBMCs) by immunoassay to assess poly (ADP-ribose) polymerase (PARP) activity. Significant inhibition of PARP activity is associated with 50% or greater reduction in PAR levels.|At baseline (t=0h) and 4h post drug administration (t=4h)|Patients with PBMCs data pre- and post-drug administration, and with PAR levels above the lower limit of quantitation (LLOQ) of 23 pg/μg protein were analyzed.||pg/μg protein||Full Range|Mean
838168|NCT01306032|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|up to 30 days following the last dose of study drug.|||Participants|||Count of Participants
838169|NCT01306032|Primary|Progression Free Survival|Time to progression for each participant for the initial intervention.|Ovarian cancer patients stayed on study for an average of 126 days and triple-negative breast cancer patients for an average of 71 days.|Participants evaluable for response.||Cycles of therapy||Full Range|Median
838170|NCT01306032|Primary|Percentage of Participants With an Overall Response Rate|Complete response (CR) + partial response (PR)) of the combination of ABT-888 with metronomic oral cyclophosphamide to the response rate (CR+PR) of metronomic oral cyclophosphamide in patients with deleterious BRCA mutations and refractory ovarian cancer or patients with primary peritoneal or ovarian high-grade serous carcinoma or fallopian tube cancer. CR + PR was determined by the Response Evaluation Criteria in Solid Tumors (RECIST). CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm). Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.|an average of 126 days for ovarian; 71 days for TNBC; for crossover intervention, pts stayed on study for an avg of 134 days for ovarian; 50 days for TNBC.|Participants evaluable for response.||percentage of participants|||Number
838171|NCT01306162|Secondary|Free Dabigatran: Maximum Measured Concentration (Cmax)|Maximum measured concentration of free dabigatran in plasma, per period.|1 h before drug administration and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration|PK set.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
838172|NCT01306162|Secondary|Free Dabigatran: Area Under the Curve 0 to Infinity (AUC0-∞)|Area under the concentration-time curve of free dabigatran in plasma over the time interval from 0 extrapolated to infinity.|1 h before drug administration and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration|PK set.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
838173|NCT01306162|Primary|Total Dabigatran: Maximum Measured Concentration (Cmax)|Maximum measured concentration of total dabigatran in plasma, per period.|1 h before drug administration and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration|PK set.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
838174|NCT01306162|Primary|Total Dabigatran: Area Under the Curve 0 to Infinity (AUC0-∞)|Area under the concentration-time curve of total dabigatran in plasma over the time interval from 0 extrapolated to infinity.|1 h before drug administration and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration|Pharmacokinetic (PK) set defined as all subjects randomised, treated and who provided evaluable data for at least one observation for at least one primary endpoint without important protocol violations relevant to the evaluation of PK.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
838175|NCT01306175|Secondary|Digoxin: Area Under the Curve 0 to Last Quantifiable Data Point (AUC0-tz)|Area under the concentration-time curve of digoxin in plasma over the time interval from 0 extrapolated to the time of the last quantifiable data point.|1.5 hours (h) prior to the first dose and 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h after the first dose|Pharmacokinetic (PK) set comprised all evaluable subjects who took at least 1 dose of study medication with at least 1 observation for at least 1 primary PK endpoint without any important protocol violations relevant to the PK evaluation. One subject was excluded from the PK set because the pre-dose plasma concentration of digoxin was >5% of Cmax.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
838176|NCT01306175|Primary|Digoxin: Maximum Measured Concentration (Cmax)|Maximum measured concentration of digoxin, per period.|1.5 hours (h) prior to the first dose and 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h after the first dose|Pharmacokinetic (PK) set comprised all evaluable subjects who took at least 1 dose of study medication with at least 1 observation for at least 1 primary PK endpoint without any important protocol violations relevant to the PK evaluation. One subject was excluded from the PK set because the pre-dose plasma concentration of digoxin was >5% of Cmax.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
838177|NCT01306175|Primary|Digoxin: Area Under the Curve 0 to Infinity (AUC0-∞)|Area under the concentration-time curve of digoxin in plasma over the time interval from 0 extrapolated to infinity.|1.5 hours (h) prior to the first dose and 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h after the first dose|Pharmacokinetic (PK) set comprised all evaluable subjects who took at least 1 dose of study medication with at least 1 observation for at least 1 primary PK endpoint without any important protocol violations relevant to the PK evaluation. One subject was excluded from the PK set because the pre-dose plasma concentration of digoxin was >5% of Cmax.||ng-h/mL||Geometric Coefficient of Variation|Geometric Mean
838178|NCT01306201|Post-Hoc|Calculate Covidien Respiration Rate Software Accuracy as Mean Error +/- Standard Deviation.||Overall average|||Breaths Per Minute (BrPM)||Standard Deviation|Mean
838179|NCT01306201|Secondary|The Covidien Nellcor Respiration Rate Software Shall Calculate Respiration Rate With a Root Mean Square Difference (RMSD) of < 3 Breaths Per Minute Compared With a End-Tidal Carbon Dioxide Waveforms, With 95% Confidence.|"The data used for analysis consisted of multiple simultaneous measures of RR_TTI, RR_V1.0 and RR_EtCO2 for each subject. Given N sets of simultaneous RR values for each of P patients, the simultaneous RR values were used to calculate a pair of RMSD values for each subject.
The two RMSD values, RMSDRR_V1.0_vs_EtCO2, and RMSDTTI_vs_EtCO2, quantify the mean absolute difference in simultaneous estimates of respiratory rate between RR_V1.0 compared with RR_EtCO2 and RR_TTI compared with RR_EtCO2, respectively for the subjects with 95% confidence of mean ± 3.38 BrPM. The Measure type is Number and represents the RMSD of Covidien Nellcor Respiration Rate Software"|Participants were monitored on average for 30 minutes|||Breaths Per Minute (BrPM)|||Number
838180|NCT01306201|Primary|The Covidien Nellcor Respiration Rate Software Shall Determine Respiration Rate Measured as Mean and Standard Deviation With Accuracy That is Non-inferior to Predicate Device.|Mean and standard deviations of respiration rates collected from patients in the hospital settings were compared between Covidien Respiration Rate Software, Transthoracic Impedance and End-Tidal Carbon Dioxide Waveforms. Each patient served as its own control.|Participants were monitored for average of 30 minutes|10 participants were excluded from data analysis due to following reasons: unreadable files,arrhythmia,electronic data files coud not be processed||BrPM (Breaths Per Minute)||Standard Deviation|Mean
838181|NCT01312129|Primary|% BOLD Response Increase Above Baseline|Test whether Sulfasalazine, as compared to placebo, diminishes blood-oxygen-level dependent (BOLD) response to alcohol cues in the striatum and prefrontal cortex (PFC). BOLD response refers to brain activation in response to the presence of oxygen in a particular part of the brain. To test the hypothesis, we will compare Sulfasalazine treatment with placebo treatment. During the fMRI scan session, participants will be presented with the alcohol cue task. We will compare the difference in BOLD response during the presence of alcohol vs. a novel substance during the alcohol cue task. Outcome data collected during the alcohol cue task will provide us with BOLD response data for each intervention period. We will analyze the outcome data using FSL (Oxford Centre for Functional MRI of the Brain (FMRIB) Software – a collection of functional and structural brain image analysis tools).|Over two weeks|||% BOLD Response increase above baseline||Standard Deviation|Mean
838182|NCT01312272|Secondary|Positive and Negative Syndrome Scale (PANSS) for Schizophrenia Total Score|"This is a frequently used instrument, initially developed by Kay, Opler, and Fiszbein, that assesses 30 different symptoms (categorized into positive, negative, and general psychopathology) on a scale from 1 to 7, based on clinical interview. It will be used to compare the psychopathology between the two treatment groups.
The maximum Total Score on the scale is 210 and the minimum score is 30, with higher values indicating more severe symptoms. The maximum scale of 210 is the sum of the scores from each symptom category (positive symptoms = range 7 to 49; negative symptoms = range 7 to 49; general psychopathology = range to 16 to 112).
Our outcome measure refers to the change in the PANSS Total Score. A greater decrease on the scale indicates greater improvement in symptoms (e.g., a participant with a change score of -20 improved more on the PANSS than a participant with a change score of -5)."|Visit 2 (baseline), Visit 3 (1 week following, post-treatment)|||change in units on scale||Standard Deviation|Mean
838183|NCT01312272|Secondary|Facial Affect Recognition (Low Level Social Cognition)|Participants are asked to identify facial expressions of emotion in still photographs from the standardized stimulus set developed by Ekman. The test includes digitized color photos of eight different posers displaying facial expressions of six basic emotions plus neutral expressions. On each trial, a photo and a list of the seven possible expressions are simultaneously presented on the screen. The participant verbally identifies the emotion he/she believes is correct and the experimenter enters the response. The dependent measure is the total number correct.|Visit 2 (baseline), Visit 3 (1 week following, post-treatment)|||Change in z-score||Standard Deviation|Mean
838184|NCT01312272|Secondary|Social Perception Assessment (Low Level Social Cognition)|We will assess social perception using the Half-Profile of Nonverbal Sensitivity (Half-PONS). Brief scenes are shown that include facial expressions, voice intonations, and/or body gestures. Subjects select a label that best describes the situation. The dependent measure is the total number of correct labels.|Visit 2 (baseline), Visit 3 (1 week following, post-treatment)|||Change in z-score||Standard Deviation|Mean
838185|NCT01312272|Secondary|Empathy|Empathy was assessed using the Emotional Perspective Taking Task (EPTT) (Derntl et al., 2009). In this task, subjects are presented with 60 digital images depicting two individuals in a social interaction, with one individual's face masked. Subjects are asked to infer the emotional expression of the masked face, selecting between two choices. Scenes portray 5 basic emotions as well as neutrality and each image is displayed for 4 s each.|Visit 2 (baseline), Visit 3 (1 week following, post-treatment)|||Change in z-score||Standard Deviation|Mean
838186|NCT01312272|Secondary|Theory of Mind Assessment (High Level Social Cognition)|The Awareness of Social Inference Test (TASIT Part III: Social Inference – Enriched) will be administered to assess theory of mind.|Visit 2 (baseline), Visit 3 (1 week following, post-treatment)|||Change in z-score||Standard Deviation|Mean
838187|NCT01312272|Primary|Social Cognition Composite Measure|"Our primary outcome measure will be a composite score created by calculating the mean of the four main social cognition measures assessed in this study (two high-level measures and two low-level measures). Because these measures are not on the same scale, we will first z-score (center and scale) each of the four measures at each time point using the baseline mean and standard deviation of the whole sample and then calculate the mean of the z-scores to create the composite social cognition score."|Visit 2 (baseline), Visit 3 (1 week following, post-treatment)|||Change in z-score||Standard Deviation|Mean
838188|NCT01313624|Secondary|Time to Protocol-Defined Exacerbation (PDE)|"Protocol-defined exacerbation was defined as an acute worsening of respiratory disease that triggered the initiation of a non-study antibiotic meeting at least 3 major criteria, or 2 major and at least 2 minor criteria.
Major Criteria: increased sputum production; increased discoloration of sputum; increased dyspnea; increased cough
Minor Criteria: fever (> 38º C) measured during clinic visit; increased malaise or fatigue; forced expiratory volume in 1 second (FEV1) (L) or forced vital capacity (FVC) decreased > 10% from baseline; new or increased hemoptysis"|Baseline to Day 112|ITT Analysis Set||days||95% Confidence Interval|Median
838189|NCT01313624|Secondary|Change in QOL-B Respiratory Symptoms Score at Day 84|The mean (SD) change in the Respiratory Symptoms score on the QOL-B was measured from baseline to the end of Course 2 (Day 84). The QOL-B respiratory symptoms score was transformed onto a scale of 0-100, with higher scores representing a better quality of life.|Baseline to Day 84|Participants in the ITT Analysis Set with scores at both baseline and Day 84 were analyzed.||units on a scale||Standard Deviation|Mean
838190|NCT01313624|Primary|Change in QOL-B Respiratory Symptoms Score at Day 28|The mean (SD) change in the Respiratory Symptoms score on the Quality of Life Questionnaire-Bronchiectasis (QOL-B) was measured from baseline to the end of Course 1 (Day 28). The QOL-B respiratory symptoms score was transformed onto a scale of 0-100, with higher scores representing a better quality of life.|Baseline to Day 28|Participants in the ITT Analysis Set with scores at both baseline and Day 28 were analyzed.||units on a scale||Standard Deviation|Mean
838195|NCT01313650|Other Pre-specified|Change From Baseline in the Mean Shortness of Breath With Daily Activities (SOBDA) Score for Week 24|The newly developed SOBDA questionnaire assesses dyspnea or shortness of breath (SOB) with daily activities. The SOBDA questionnaire is made up of 13 items completed by the participant (par.) each evening prior to bedtime, when the par. is instructed to reflect on the current day’s activities. The daily score is computed as the mean of the scores on the 13 items (>=7 items must have non-missing responses for this to be calculated). The par. is assigned a weekly mean SOBDA score ranging from 1 to 4 (greater scores indicate more severe breathlessness with daily activities) based on the mean of 7 days of data (>=4 of 7 days must be completed for a weekly mean to be calculated). Change from BL is the mean weekly SOBDA score minus BL. Analysis was performed using MMRM with covariates of treatment, BL (mean score in the week prior to treatment), smoking status, center group, week, week by BL and week by treatment interactions. This MMRM analysis only included Weeks 4, 8, 12, and 24.|Baseline and Week 24|Intent-to-Treat (ITT) Population: all par. randomized to trt. who received at least one dose of randomized study drug. Par. represents those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis.||Scores on a scale||Standard Error|Least Squares Mean
838196|NCT01313650|Secondary|Change From Baseline in Weighted Mean (WM) 0-6 Hour FEV1 Obtained Post-dose at Day 168|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The WM FEV1 was derived by calculating the area under the FEV1/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. The WM was calculated at Days 1, 28, 84, and 168 using the 0-6-hour post-dose FEV1 measurements collected on that day, which included pre-dose (Day 1: 30 minutes [min] and 5 min prior to dosing; other serial visits: 23 and 24 hours after the previous morning dose) and post-dose at 15 min, 30 min, 1 hour, 3 hours, and 6 hours. Change from Baseline at a particular visit was calculated as the WM at that visit minus Baseline. Analysis was performed using a repeated measures model with covariates of treatment, Baseline (mean of the two assessments made 30 min and 5 min pre-dose on Day 1), smoking status, center group, day, and day by Baseline and day by treatment interactions.|Baseline and Day 168|Intent-to-Treat (ITT) Population: all par. randomized to trt. who received at least one dose of randomized study drug. Par. represents those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis.||Liters||Standard Error|Least Squares Mean
838197|NCT01313650|Secondary|Mean Transition Dyspnea Index (TDI) Focal Score at Day 168 (Week 24)|Considered an 'other' endpoint by the FDA. The TDI is an interviewer-administered instrument which measures the changes in the participant's dyspnea from Baseline. This questionnaire was collected on Days 28, 84 and 168. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI scores ranged from -3 (major deterioration) to +3 (major improvement); total score = -9 to 9. Analysis was performed using a repeated measures model with covariates of treatment, Baseline dyspnea index (BDI) focal score,smoking status, center group, day, day by BDI focal score and day by treatment interactions.|Day 168 (Week 24)|Intent-to-Treat (ITT) Population: all par. randomized to trt. who received at least one dose of randomized study drug. Par. represents those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis.||Scores on a scale||Standard Error|Least Squares Mean
838198|NCT01313650|Primary|Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 169 (Week 24)|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 measurements were taken electronically by spirometry on Days 2, 28, 56, 84, 112, 168, and 169. Baseline is defined as the mean of the assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1. Trough FEV1 is defined as the mean of the FEV1 values obtained at 23 and 24 hours after the previous morning's dosing (ie., trough FEV1 on Day 169 is the mean of the FEV1 values obtained 23 and 24 hours after the morning dosing on Day 168). Change from Baseline at a particular visit was calculated as the trough FEV1 at that visit minus Baseline. Analysis was performed using a repeated measures model with covariates of treatment, Baseline , smoking status, center group, day, and day by Baseline and day by treatment interactions. ITT=Intent-to-Treat; par.=participants.|Baseline and Day 169|Intent-to-Treat (ITT) Population: all par. randomized to trt. who received at least one dose of randomized study drug. Par. represents those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis.||Liters||Standard Error|Least Squares Mean
838199|NCT01313663|Secondary|Number of Participants With the Indicated Changes From Baseline Value in Lactate Dehydrogenase (LDH)|"Change from Baseline in the laboratory parameter LDH was assessed as decrease to low, change to normal of no change, and increase to high. Participants with missing Baseline values were assumed to have a normal Baseline value. There is no standard normal range for LDH."|From the time of the first dose of study treatment until 28 days following discontinuation of study treatment (up to Study Week 55)|Safety Population||participants|||Number
838200|NCT01313663|Secondary|Number of Participants With the Indicated Grade Changes From Baseline Grade in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk. Phos.), and Total Bilirubin (TB)|The laboratory parameters AST, ALT, Alk. Phos., and TB were summarized according to NCI CTCAE grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3, Severe; Grade 4, Life-threatening or disabling; Grade 5, Death. Data are presented for any grade increase, increase to Grade 3, and increase to Grade 4. Participants with missing Baseline grades were assumed to have a Baseline grade of 0. AST/ALT: Grade 1, >upper limit of normal (ULN) - 3.0x ULN; Grade 2, >3.0 to 5.0x ULN; Grade 3, >5.0 - 20.0x ULN; Grade 4, >20.0x ULN; Grade 5, not available (NA). Alk. Phos.: Grade 1, >ULN - 2.5x ULN; Grade 2, >2.5 - 5.0x ULN; Grade 3, >5.0 - 20.0x ULN; Grade 4, >20.0x ULN; Grade 5, NA. TB: Grade 1, >ULN - >1.5x ULN; Grade 2, >1.5 - 3.0x ULN; Grade 3, >3.0 - 10.0x ULN; Grade 4, >10.0x ULN; Grade 5, NA.|From the time of the first dose of study treatment until 28 days following discontinuation of study treatment (up to Study Week 55)|Safety Population||participants|||Number
838201|NCT01313663|Secondary|Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Clinical Laboratory Parameters|Hematology and clinical chemistry data were summarized according to National Cancer Institutes (NCI) CTCAE grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3, Severe; Grade 4, Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to Grade 3 or Grade 4 occurred. Participants with missing Baseline grades were assumed to have a Baseline grade of 0. Lymphocyte count increased: Grade 3, <500 - 200/millimeters cubed (mm^3); <0.5 - 0.2x 10e9/Liters (L); Grade 4, <200/mm^3; <0.2x 10e9/L. Lymphocyte count decreased: Grade 3, >20000/mm^3; Grade 4, NA. Hyperglycemia; Grade 3, >250 - 500 milligrams per deciliter (mg/dL); >13.9 - 27.8 millimoles per Liter (mmol/L); hospitalization indicated; Grade 4, >500 mg/dL; >27.8 mmol/L; life-threatening consequences. Hypophosphatemia (inorganic phosphorus): Grade 3, <2.0 - 1.0 mg/dL, <0.6 - 0.3 mmol/L; Grade 4, <1.0 mg/dL, <0.3 mmol/L, life-threatening consequences.|From the time of the first dose of study treatment until 28 days following discontinuation of study treatment (up to Study Week 55)|Safety Population||participants|||Number
838202|NCT01313663|Secondary|Number of Participants With a Increase From Baseline in Bazett's QTc at the Indicated Time Points|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. In clinical studies with pazopanib, events of QT prolongation have occurred.|Baseline; Week 6; Week 15; every 9 weeks in the first 6 months; every 12 weeks in the next 6 months; and, after 1 year, every 6 months (up to Study Week 55)|Safety Population||participants|||Number
838203|NCT01313663|Secondary|Number of Participants With the Indicated Worst-case Change From Baseline in Blood Pressure|Systolic and diastolic blood pressure (BP) were measured. Categories correspond to the following Common Terminology Criteria for Adverse Events (CTCAE) grades: normal, <120/80 millimeters of mercury (mmHg); prehypertension, 120–139/80–89 mmHg, warranting intervention in participants with high risk; stage I hypertension, 140–159/90–99 mmHg, warranting intervention; and stage II hypertension >/=160/100, warranting immediate attentive intervention to prevent acute symptoms. An increase is defined as an increase in CTCAE grade relative to Baseline grade. Participants with a missing Baseline value were assumed to have a Baseline value of <120 for systolic BP (SBP) and <80 for diastolic BP (DBP).|From the time of the first dose of study treatment until 28 days following discontinuation of study treatment (up to Study Week 55)|Safety Population||participants|||Number
838204|NCT01313663|Secondary|Number of Participants With Any On-therapy AE (Serious or Non-serious) Leading to Dose Reductions (DRs) or Interruptions/Delays in the Study|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect. In addition, all Grade 4 laboratory abnormalities and other medically important events that require medical or surgical intervention to prevent one of the outcomes listed previously are considered to be SAEs. Refer to the general Adverse AE/SAE module for a complete list of AEs/SAEs. Management of AEs may require DRs/interruptions in study treatment. If necessary, the pazopanib dose should be reduced stepwise by 200 mg at each step. DRs for pemetrexed were 50-75% of prior dose based on the toxicity leading to DR.|From the time the first dose of study treatment was administered until discontinuation of treatment (up to Study Week 55)|Safety Population||participants|||Number
838205|NCT01313663|Secondary|Number of Participants With Any AE (Serious or Non-serious) Leading to Withdrawal From Study Treatment|An AE is defined as any untoward medical occurrence in a subject or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect. In addition, all Grade 4 laboratory abnormalities and other medically important events that require medical or surgical intervention to prevent one of the outcomes listed previously are considered to be SAEs. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs. A participant cold have been withdrawn fom study treatment due to an SAE or AE.|From the time the first dose of study treatment was administered until withdrawal from study treatment (up to Study Week 55)|Safety Population||participants|||Number
838206|NCT01313663|Secondary|Average Dose of Pemetrexed for All Cycles, as a Measure of Extent of Exposure|"The average dose of pemetrexed for all cycles, as a measure of extent of exposure, was assessed in all participants who received pemetrexed. The average dose was not measured in participants receiving pazopanib. For these participants, extent of exposure was measured as the time on study treatment and mean daily dose. See the outcome measures entitled Time on study treatment (pazopanib), as a measure of extent of exposure and Mean daily dose, as a measure of extent of exposure, respectively, for pazopanib data."|From the time the first dose of study treatment was administered until discontinuation of the study or death (average of 16 weeks)|Safety Population||milligrams per meters squared (m^2)||Standard Deviation|Mean
838385|NCT01316055|Primary|The Steady State Area Under the Drug Concentration Time Curve From 0 to 12 Hours Post Dose AUC(0-12).|AUC(0-12) was based on blood samples taken at specified outcome measure time frame for dalfampridine-ER 7.5 mg tablets in healthy adult volunteers and people with mild or moderate renal impairment.|0 and 1,2,3,4,5,6,8, and 12 hours after the last dose|Intention to treat (ITT)||hour*nanogram/milliliter||90% Confidence Interval|Geometric Mean
838207|NCT01313663|Secondary|Mean Number of Pemetrexed Dosing Cycles, as a Measure of Extent of Exposure|"Duration of therapy/time on study treatment, measured as the mean number of pemetrexed dosing cycles as a measure of extent of exposure, was assessed in all participants who received pemetrexed. The mean number of dosing cycles was not measured in participants receiving pazopanib. For these participants, extent of exposure was measured as the time on study treatment and mean daily dose. See the outcome measures entitled Time on study treatment (pazopanib), as a measure of extent of exposure and Mean daily dose, as a measure of extent of exposure, respectively, for pazopanib data."|From the time the first dose of study treatment was administered until discontinuation of the study or death (average of 16 weeks)|Safety Population||number of cycles||Standard Deviation|Mean
838208|NCT01313663|Secondary|Mean Daily Dose, as a Measure of Extent of Exposure|"Mean daily dose, as a measure of extent of exposure, was assessed in all participants who received pazopanib. Mean daily dose was not measured in participants receiving pemetrexed. For these participants, extent of exposure was measured as the mean number of dosing cycles and dose intensity. See the outcome measures entitled Mean number of dosing cycles, as a measure of extent of exposure and Average dose of pemetrexed for all cycles, as a measure of extent of exposure, respectively, for pemetrexed data."|From the first day to the last day of treatment (average of 8 weeks)|Safety Population||milligrams||Standard Deviation|Mean
838209|NCT01313663|Secondary|Time on Study Treatment (Pazopanib), as a Measure of Extent of Exposure|"Time on study treatment, as a measure of extent of exposure, was assessed in all participants who received pazopanib. Time on study treatment was not measured in participants receiving pemetrexed. For these participants, extent of exposure was measured as the mean number of dosing cycles and dose intensity. See the outcome measures entitled Mean number of dosing cycles, as a measure of extent of exposure and Average dose of pemetrexed for all cycles, as a measure of extent of exposure, respectively, for pemetrexed data."|From the first day to the last day of treatment (average of 8 weeks)|Safety Population||months||Standard Deviation|Mean
838210|NCT01313663|Secondary|Number of Participants With Any Non-serious On-therapy Adverse Event (AE: Occurring in >=5% Participants in Any Treatment Arm) and Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect. In addition, all Grade 4 laboratory abnormalities and other medically important events that require medical or surgical intervention to prevent one of the outcomes listed previously are considered to be SAEs. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.|From the time the first dose of study treatment was administered until 28 days following discontinuation of study treatment regardless of initiation of a new cancer therapy or transfer to hospice (up to Study Week 55)|Safety Population: all participants who were randomized and took at least one dose of study medication. This population was based on the actual treatment received, if it differed from that to which the participant was randomized.||participants|||Number
838211|NCT01313663|Secondary|Number of Participants (Par.) With the Indicated Best Overall Response|A par. was defined as a responder if s/he sustained a CR (The disappearance of all target lesions. Any pathological lymph node must be less than 10 millimeters [mm] in the short axis) or PR (At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters) that was confirmed after >=28 days. Response was evaluated by an investigator per RECIST, version 1.1. A par. without a post-Baseline assessment was considered a non-responder. Stable disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started). To qualify as a best response of SD, a response of SD had to be observed >=12 weeks after randomization. A par. who was not evaluable had no scans at all or did not have a confirmatory scan.|From randomization until the time of the first documented evidence of a confirmed complete response (CR) or partial response (PR) (average of 10 weeks)|ITT Population||participants|||Number
838212|NCT01313663|Secondary|Overall Survival|Overall survival is defined as the interval between the date of randomization and the date of death from any cause.|From randomization until disease progression or death (up to Study Week 78)|The study size (20 participants) and follow up were not adequate to assess overall survival. Participants who had not died at the time of the cut-off for the analysis were to be censored at the date the particpant was last known to be alive.|||||
838213|NCT01313663|Primary|Progression Free Survival (PFS)|PFS is defined as the interval between the date of randomization and the first documented sign of investigator-assessed (per Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1) disease progression (PD) or death, whichever occurs first. The date of documented PD is the date of lesion evaluation in the case of radiological PD and the date of symptomatic cancer progression in the case of symptomatic progression (radiological confirmation is required). PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started. If the participant received subsequent anti-cancer therapy prior to the date of documented progression or death, PFS was to be censored at the last adequate assessment (LAA) prior to the initiation of therapy. Otherwise, if the participant did not have a documented date of progression or death, PFS was to be censored at the date of the LAA.|From randomization until the first documented sign of investigator-assessed disease progression or death, whichever occurred first (average of 10 study weeks)|Intent-to-Treat (ITT) Population: all participants who were randomized to study treatment regardless of whether or not treatment was administered||weeks||90% Confidence Interval|Median
838237|NCT01313728|Primary|Expert Grader Assessment - Erythema|Ordinal erythema scores (on a scale of 0=none to 8=severe scaling and fissuring) were collected on weekdays for two weeks and the total daily score (for all subjects) was treated as a single interval measurement for comparative assessment between treatment regimens. Thus, for the total for the 25 Participants measured, minimum possible score reported below is 0 and maximum is 2000 (highest possible score of 8, times 10 days, times 25 subjects).|Baseline to 2 Weeks|Intention to Treat (ITT)||Scores on a Scale|||Number
838217|NCT01313689|Secondary|Mean Health Change Questionnaire (HCQ) Score|The HCQ consists of a single question in which the participant is asked if he/she has experienced any change in his/her health overall since beginning the study. For HCQ, values from 1 to 9 were assigned to the 9 responses in the HCQ questionnaire, ranging from 1 for ‘my health is a great deal better’ to 9 for ‘my health is a great deal worse’ since the beginning of the study. A score of 3 or less indicates improvement from Baseline. HCQ was assessed at Screening; Week (W) 12 (W4 of Cycle[C] 3), W24 (W4C6), W36 (W4C9), W48 (W4C13); during follow-up which was every month for Months 1-6, every 8 weeks for M7-12 and every 3 months up to M60; and then at PD..|From the randomization date up to 60 months post the randomization date.|ITT population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population. .||Unit on a scale||Standard Deviation|Mean
838218|NCT01313689|Secondary|Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)|The EORTC QLQ-CLL16 is comprised of 16 questions that address 5 domains of health-related quality of life (HRQoL) important in CLL. There are 4 multi-item scales – fatigue (2 items), treatment side effects ([TSE], 4 items), disease symptoms (disease effects scale [DES], 4 items), and infection (4 items) – and single item scales (social activities [Social Problems (SP) Scale] and future health worries[Future Health (FH) Scale].). These are measured on a four point scale where 1 = not at all and 4 = very much. These scores are transformed to give a rating from 0 – 100, where 0 =no symptoms or problems and 100 = a severe symptoms or problems. EORTC QLQ-CLL16 was assessed at Screening; Week (W) 12 (W4 of Cycle[C] 3), W24 (W4C6), W36 (W4C9), W48 (W4C13); during Follow-up which was every month for Months (M) 1-6, every 8 weeks for M7-12 and every 3 months up to M60; and then at PD.|From the randomization date up to 60 months post the randomization date.|ITT population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population.||unit on a scale||Standard Deviation|Mean
838219|NCT01313689|Secondary|Number of Participants Who Were Positive or Negative for Human Anti-Human Antibodies (HAHA) Post-OFA Therapy|The presence of HAHA in human serum was determined using a validated electrochemiluminescent assay in a multi-tier assay format. All samples were first assessed in a screening (SCR) assay, and the potential positive (Pos) samples were further tested in the confirmation (CNF) assays. Confirmed positives were reported as HAHA positive and titer was determined for each positive sample. The drug tolerance of the HAHA assay is 200 microgram/milliliter (µg/mL); thus, samples that tested negative in the assay and had ofatumumab concentrations no more than 200 µg/mL were considered as conclusive negative (Neg) results.|From the randomization date up to 60 months post the randomization date.|Safety Population. Only those participants with post-OFA treatment HAHA results were analyzed.||Participants|||Number
838238|NCT01313780|Secondary|Change in Bowel Habits.|The change of bowel habits from baseline (Visit 1) in bowel habits at Week 4 was investigated, and was categorized as ‘improved’, ‘unchanged’, and ‘worsened’.|4 weeks|FAS analysis, but Oxycodone/naloxone group was missed 15 patients data and Oxycodone group was missed 23 patients data.||participants|||Number
838239|NCT01313780|Primary|Change of Pain Intensity From Baseline(visit1) to 4weeks.(visit3)|Change of pain intensity from 0(No pain) to 10(worst pain imaginable) after 4 weeks treatment .|4weeks|Analysis of FAS: 117.||units on a scale||Standard Deviation|Mean
838220|NCT01313689|Secondary|Mean Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM Over Time|Immunoglobulins or antibodies are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Low levels indicate immuno-suppression. IgA, IgG, and IgM were measured in the blood samples of the participants. Immunoglobulin testing was performed at Screening (SCR), Cycle 3 Week 4 (C3W4), Cycle 7 Week 4 (C3W4) ,Cycle 9 Week 4 (C3W4), 6 Month Follow-up Visit (6M FU), 9 Month Follow-up (9M FU), 12 Month Follow-up (12M FU), 18 Month Follow-up (18M FU), 24 Month Follow-up (24M FU), 30 Month Follow-up (30M FU). A cycle is defined as the time between one round of treatment until the start of the next round.|Screening and every 3 months during treatment, every 6 months after last treatment until PD or until 30 Month Follow-up Visit|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.||Gram per liter||Standard Deviation|Mean
838221|NCT01313689|Secondary|Number of Participants With Any Adverse Event (AE) of Special Interest|AEs of special interest included cytopenias (neutropenia [decreased neutrophil count], anaemia [decreased hemoglobin], and thrombocytopenia [decreased platelet count]), autoimmune haematologic complications (autoimmune haemolytic anaemia and haemolytic anaemia), infusion reactions, infections, mucocutaneous reactions, Tumour Lysis Syndrome (TLS), cardiovascular events, and small bowel obstruction.|From the first dose of study medication to 60 days after the last dose of study medication and until follow-up for SAEs unless initiation of subsequent anti-CLL therapy (Median follow-up approximately 28.9 months)|Safety Population||Participants|||Number
838222|NCT01313689|Secondary|Number of Participants With Any Adverse Event (AE), Any Serious Adverse Event (SAE), Any Fatal Serious Adverse Event (FSAE), or Deaths|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, is a congenital anomaly or birth defect.|From the first dose of study medication to 60 days after the last dose of study medication and until follow-up for SAEs unless initiation of subsequent anti-CLL therapy (Median follow-up approximately 28.9 months)|Safety Population: all participants who received at least one dose of any study treatment (OFA or PC) at the first randomization.||Participants|||Number
838223|NCT01313689|Secondary|Duration of Response as Assessed by the IRC|DOR is defined as the time from the initial response (CR, CRi, nPR, or PR) to the first documented sign of PD or death due to any cause. PD requires at least one of the following: lymphadenopathy, appearance of any new lesion such as enlarged lymph nodes (>1.5 cm) spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site; an increase by 50% or more in the previously noted enlargement of the liver or spleen, an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter, transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukaemia. Par. who were alive and had not progressed at the time of analysis or if a progression event occurred after extensive lost-to-follow-up time (>= 12 weeks) were censored at the date of the last visit with adequate assessment. Par. with unknown or missing responses were considered as non-responders.|From the randomization date up to 60 months post the randomization date.|ITT population. Only those participants with data available at the indicated time points were analyzed. Only responders (CR, CRi, PR, nPR) were included in the analysis.||Months||95% Confidence Interval|Median
838224|NCT01313689|Secondary|Time to Response as Assessed by the IRC|Time to response is defined as the time from randomization to the first response (Complete Remission[CR], Complete Remission with incomplete bone marrow recovery[CRi], partial response[PR], or nodular PR[nPR]). CR(all the criteria at least 2 months after last treatment): no lymphadenopathy(Ly) > 1.5 cm/ hepatomegaly/ splenomegaly/ constitutional symptoms; neutrophils >1500 per microliter(µL), platelets(PL) >100,000/µL, hemoglobin(Hb) >11 grams/deciliter(g/dL), lymphocytes(LC) <4000/µL, bone marrow(BM) sample must be normocellular for age, <30% LC, no lymphoid nodule. CRi: CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to CLL but related to drug toxicity. PR: >=50% decrease in LC, Ly, size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline(BL), Hb >11 g/dL or 50% improvement over BL. nPR: persistent nodules BM. Participants with unknown or missing responses were considered as non-responders.|From the randomization date up to 60 months post the randomization date.|ITT population. Only responders (CR, CRi, PR, nPR) were included in the analysis. Response was measured using the International Workshop for CLL (IWCLL) updated National Cancer Institute-sponsored Working Group (NCI-WG) guidelines 2008.||Months||95% Confidence Interval|Median
838225|NCT01313689|Secondary|Time to Next Anti-cancer Therapy by Investigator|Time to next therapy is defined as the time from randomization until the start of the next line of treatment.|From the randomization date up to 60 months post the randomization date.|ITT population. Only those participants with data available were analyzed.||Months||95% Confidence Interval|Median
838226|NCT01313689|Secondary|Time to Progression as Assessed by IRC|Time to progression is defined as the time from the date of randomization to disease progression (PD). PD requires at least one of the following: lymphadenopathy, appearance of any new lesion such as enlarged lymph nodes (>1.5 cm) spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site; an increase by 50% or more in the previously noted enlargement of the liver or spleen, an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter, transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukaemia. Participants who were alive and had not progressed at the time of analysis or if a progression event occurred after extensive lost-to-follow-up time were censored at the date of the last visit with adequate assessment.|From the randomization date up to 60 months post the randomization date.|ITT population. Only those participants with data available were analyzed.||Months||95% Confidence Interval|Median
838227|NCT01313689|Secondary|Overall Survival|Overall survival (OS) is defined as the time from randomization to death due to any cause. Kaplan-Meier plots were used to estimate the reported median OS time.|From the randomization date up to 60 months post the randomization date.|ITT population. Only those participants with data available were analyzed, participants who had not died were censored at the date of last contact.||Months||95% Confidence Interval|Median
838228|NCT01313689|Secondary|Overall Response Rate (ORR) as Assessed by the Investigator|ORR is defined as the number of participants achieving either complete response (CR) or partial response (PR). Overall response was measured using the IWCLL updated NCI-WG guidelines 2008. CR requires all of the following criteria: no lymphadenopathy(Ly)/ hepatomegaly, splenomegaly, constitutional symptoms; neutrophils >1500 per microliter(µL), platelets(PL) >100,000/µL, hemoglobin(Hb) >11 grams/deciliter(g/dL), lymphocytes(LC) <4000/µL, bone marrow(BM) sample must be normocellular for age, <30% LC and no lymphoid nodules. PR requires the following criteria for at least 2 months: >=50% decrease in LC, reduction in Ly (i.e., >=50% decrease in lymph node size or no increase or new lymph nodes), >=50% decrease in the size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline(BL), Hb >11 g/dL or 50% improvement over BL, neutrophils>1500/μL. Nodular PR (nPR) indicates persistent nodules in the BM.|From the randomization date up to 60 months post the randomization date.|ITT Population. Not evaluable is defined as insufficient data present to classify into one of the other categories.||Participants|||Number
838229|NCT01313689|Secondary|Overall Response Rate (ORR) as Assessed by the IRC|ORR is defined as the number of participants achieving either complete response (CR) or partial response (PR). ORR was measured using the IWCLL updated NCI-WG guidelines 2008. CR requires all of the following criteria: no lymphadenopathy(Ly)/ hepatomegaly, splenomegaly, constitutional symptoms; neutrophils >1500 per microliter(µL), platelets(PL) >100,000/µL, hemoglobin(Hb) >11 grams/deciliter(g/dL), lymphocytes(LC) <4000/µL, bone marrow(BM) sample must be normocellular for age, <30% LC and no lymphoid nodules. PR requires the following criteria for at least 2 months: >=50% decrease in LC, reduction in Ly (i.e., >=50% decrease in lymph node size or no increase or new lymph nodes), >=50% decrease in the size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline(BL), Hb >11 g/dL or 50% improvement over BL, neutrophils>1500/μL. Nodular PR (nPR) indicates persistent nodules in the BM.|From the randomization date up to 60 months post the randomization date.|ITT Population. Not evaluable is defined as insufficient data present to classify into one of the other categories.||Participants|||Number
838230|NCT01313689|Secondary|Progression-free Survival (PFS) as Assessed by Investigator|PFS is the interval of time between the date of first randomization to the date of disease progression (PD) or death due to any reason, whichever occurred first. The date of PD was defined as the first occurrence of any criteria of progression. PD criteria requires at least one of the following: progression of lymphadenopathy, >=50% increase in liver or spleen size, >=50% increase in number of lymphocytes per microliter, more aggressive histology, occurence of cytopenia after treatment attributable to CLL. Disease progression was determined according to the 2008 International Workshop for Chronic Lymphocytic Leukaemia (IWCLL) update of the National Cancer Institute-sponsored Working Group CLL Guidelines for Response (NCI-WG). PFS was censored at the time of the last follow up for participants who have neither progressed or died.|From the randomization date up to 60 months post the randomization date.|Intent-to-treat (ITT) population: all participants who were randomised to receive OFA or PC at the first randomisation.||Months||95% Confidence Interval|Median
838231|NCT01313689|Primary|Progression-free Survival (PFS) as Assessed by Independent Review Committee (IRC)|PFS is the interval of time between the date of first randomization to the date of disease progression (PD) or death due to any reason, whichever occurred first. The date of PD was defined as the first occurrence of any criteria of progression. PD criteria requires at least one of the following: progression of lymphadenopathy, >=50% increase in liver or spleen size, >=50% increase in number of lymphocytes per microliter, more aggressive histology, occurence of cytopenia after treatment attributable to CLL. Disease progression was determined according to the 2008 International Workshop for Chronic Lymphocytic Leukaemia (IWCLL) update of the National Cancer Institute-sponsored Working Group CLL Guidelines for Response (NCI-WG). PFS was censored at the time of the last follow up for participants who have neither progressed or died.|From the randomization date up to 60 months post the randomization date.|Intent-to-treat (ITT) population: all participants who were randomised to receive OFA or PC at the first randomisation.||Months||95% Confidence Interval|Median
838232|NCT01313728|Secondary|Facial Tolerance|All interval measurements were combined for comparative assessment between treatment regimens. Facial tolerance is the sum of scores from Erythema, Dryness, Burning/Stinging, Itching, and Tightness assessments, reported in Outcome Measures 1-5. Thus, for the total for the 25 Participants measured, minimum possible score reported below is 0 and maximum is 6250 (highest possible combined score of 25, times 10 days, times 25 subjects).|Baseline to 2 Weeks|||Scores on a Scale|||Number
838233|NCT01313728|Secondary|Subject Assessment – Tightness|Ordinal tightness scores (on a scale of 0=none to 3=severe) were collected on weekdays for two weeks and the total daily score (for all subjects) was treated as a single interval measurement for comparative assessment between treatment regimens. Thus, for the total for the 25 Participants measured, minimum possible score reported below is 0 and maximum is 750 (highest possible score of 3, times 10 days, times 25 subjects).|Baseline to 2 Weeks|Intention to Treat (ITT)||Scores on a Scale|||Number
838234|NCT01313728|Secondary|Subject Assessment – Itching|Ordinal itching scores (on a scale of 0=none to 3=severe) were collected on weekdays for two weeks and the total daily score (for all subjects) was treated as a single interval measurement for comparative assessment between treatment regimens. Thus, for the total for the 25 Participants measured, minimum possible score reported below is 0 and maximum is 750 (highest possible score of 3, times 10 days, times 25 subjects).|Baseline to 2 Weeks|Intention to Treat (ITT)||Scores on a Scale|||Number
838235|NCT01313728|Secondary|Subject Assessment – Burning/Stinging|Ordinal burning/stinging scores (on a scale of 0=none to 3=severe) were collected on weekdays for two weeks and the total daily score (for all subjects) was treated as a single interval measurement for comparative assessment between treatment regimens. Thus, for the total for the 25 Participants measured, minimum possible score reported below is 0 and maximum is 750 (highest possible score of 3, times 10 days, times 25 subjects).|Baseline to 2 Weeks|Intention to Treat (ITT)||Scores on a Scale|||Number
838236|NCT01313728|Primary|Expert Grader Assessment - Dryness|Ordinal dryness scores (on a scale of 0=none to 8=deep) were collected on weekdays for two weeks and the total daily score (for all subjects) was treated as a single interval measurement for comparative assessment between treatment regimens. Thus, for the total for the 25 Participants measured, minimum possible score reported below is 0 and maximum is 2000 (highest possible score of 8, times 10 days, times 25 subjects).|Baseline to 2 Weeks|Intention to Treat (ITT)||Scores on a Scale|||Number
838253|NCT01313910|Primary|Number of Bowel Movements Per Day|self-reported bowel movement in diary|8 weeks (56 days)|||bowel movements/day||Inter-Quartile Range|Median
838240|NCT01313858|Primary|Number of Participants Who Experienced at Least One Serious Adverse Event|A serious adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure that results in death, life-threatening adverse event, permanent or significant disability / unfitness for work, hospital treatment (i.e., admission to hospital) or prolongation of a patient's length of stay, or congenital deformity or birth defect.|Up to 24 months|The safety population consists of all participants with at least one injection of Simponi®.||Participants|||Number
838241|NCT01313858|Primary|Number of Participants Who Experienced at Least One Adverse Event|An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.|Up to 24 months|The safety population consists of all participants with at least one injection of Simponi®.||Participants|||Number
838242|NCT01313858|Primary|Change From Baseline in EuroQol- 5 Dimension 3 Level Version (EQ-5D-3L) Questionnaire Score|"The EQ-5D-3L is a health profile questionnaire that assesses quality of life along 5 dimensions. Participants rate 5 aspects of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) by choosing from 3 answering options (1=no problems; 2=some problems; 3=extreme problems). The summed score ranges from 1-15 with 1 corresponding to no problems and 15 corresponding to severe problems in the 5 dimensions. Decrease from baseline in EQ-5D-3L signifies improvement."|Baseline and Months 6, 12, 18, 24|The mITT population consists of all participants who were treated with Simponi® and have a baseline assessment and at least one additional visit, regardless of any protocol violations during the study.||Units on a scale||Standard Deviation|Least Squares Mean
838243|NCT01313858|Primary|Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score|The FACIT-F scale assesses self-reported fatigue and its impact upon daily activities and function. 13 items consisting of fatigue, weakness, listlessness, tiredness, trouble with starting things, trouble with finishing things, energy, activity, sleep, eating, help doing activities, frustration, and social activities are scored on a scale of 0 (not at all) to 4 (very much), except energy and activity which are reversed scored. Individual item scores are then summed to provide the final FACIT-F score with range from 0 (lowest) to 52 (highest quality of life). Increase from baseline in FACIT-F score signifies improvement.|Baseline and Months 3, 6, 12, 18, 24|The mITT population consists of all participants who were treated with Simponi® and have a baseline assessment and at least one additional visit, regardless of any protocol violations during the study.||Units on a scale||Standard Deviation|Least Squares Mean
838244|NCT01313858|Primary|Change From Baseline in FFbH (Funktionsfragebogen Hannover) Questionnaire Score|The FFbH is a participant questionnaire assessing disability/functional impairment. Ability to perform 18 activities of daily living are scored on a 3 point scale (2=Yes, 1=Yes but with effort, and 0=No or with assistance) and summed. Remaining functional capacity is calculated as the percent of the maximum number of score points (FFbH[%] = (Attained score*100)/(2*n) where n is the number of completed responses) with range from 0 = total loss of functional capacity to 100 = maximal functional capacity. Increase from baseline in FFbH score signifies improvement. The FFbH is similar to Health Assessment Questionnaire (HAQ) but is more widely used in Germany.|Baseline and Months 3, 6, 9, 12, 15, 18, 21, 24|The mITT population consists of all participants who were treated with Simponi® and have a baseline assessment and at least one additional visit, regardless of any protocol violations during the study.||Units on a scale||Standard Deviation|Least Squares Mean
838245|NCT01313858|Primary|Clinical Global Impression (CGI) Disease Status|"The CGI is a non-disease-specific evaluation of participants' overall health status assessed on a 10 mm visual analogue scale (VAS) ranging from 0 (free of complaints) to 10 (strong discomfort). The closer the score to 0, the better the health status."|Baseline (BL; Month 0), Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21, Month 24|The mITT population consists of all participants who were treated with Simponi® and have a baseline assessment and at least one additional visit, regardless of any protocol violations during the study.||Units on a scale||Standard Deviation|Least Squares Mean
838246|NCT01313884|Secondary|Progression Free Survival||24 months||||||
838247|NCT01313884|Primary|Overall Response Rate (Partial and Complete Response)|"Response was evaluated every 12 weeks during treatment. Subjects who discontinue treatment for reasons other than disease progression or initiation of new anticancer therapy (excluding radiation therapy and surgery) response evaluated every 6 months following the last dose of study drug. Scans should be obtained every 6 months for 2 years or until progression of disease or initiation of new anticancer therapy.
Complete response (CR) Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
Partial response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as a reference the baseline sum diameters."|Up to 24 months|||Participants|||Count of Participants
838248|NCT01313897|Primary|Therapeutic Efficacy|Number of participants with an objective response of Partial Response (PR) or better according to European Society for Blood and Marrow Transplantation (EBMT) criteria within 180 days post Expanded Natural Killer Cell Infusion. The minimum criteria to meet the EBMT definition of PR or better included: >= 50% reduction in size of soft tissue plasmacytomas (if assessed); AND >= 50% reduction in plasma cells in bone marrow biopsy (if biopsy was performed and if >= 30% plasma cells at baseline); AND >=50% reduction in serum M protein and reduction in urine M protein >= 90% or to 200 mg/24hr OR >= 50% decrease in the difference between involved and uninvolved serum free light chain levels (if serum M protein < 1 g/dL, urine < 200 mg/24 hrs, and an involved serum free light chain level >= 10 mg/dL at baseline).|180 days|||Participants|||Count of Participants
838249|NCT01313910|Secondary|Duodenal Immune Reconstitution|changes in duodenal lamina propria CD3+/CD4+ density by immunohistochemistry|8 weeks|||CD3+/CD4+ per mm^2 lamina propria||Inter-Quartile Range|Median
838250|NCT01313910|Secondary|Systemic Immune Activation|CD8+ T-cells with an activated phenotype (HLA-DR/CD38+ coexpression)|8 weeks|||% CD8/HLA-DR/CD38+||Inter-Quartile Range|Median
838251|NCT01313910|Secondary|Measures of Gut Permeability|five-hour disaccharide absorption test|8 weeks|||percentage absorption||Inter-Quartile Range|Mean
838252|NCT01313910|Secondary|Frequency of Pro-inflammatory Bacterial Orders|16S rDNA sequencing for Bacteroidetes/Firmicutes ratio|8 weeks|||ratio of Bacteroidetes/Firmicutes %||Inter-Quartile Range|Median
838254|NCT01313923|Secondary|Statistical Measures|"The statistical goal is to observe success, an improvement in disease control while up-titrating sirolimus dosage. As there will be no control group, the subject or progress at the end of the study will be compared to their baseline at the beginning of the study. The subject and disease severity at the beginning of the study will be compared to the disease severity at each visit and be correlated with the dosage of sirolimus and corticosteroid. However, since no patient completed the study, the outcome and any data collected was not assessed."|Study early termination by investigator - no participant completed any visits of the study - no measurements taken||||||
838255|NCT01313923|Primary|Improvement of ABSIS Score While Reducing Steroid Dosage|"Measurement of disease severity will be quantified using ABSIS (Autoimmune Bullous Skin Disorder Intensity Score). Improvement in disease control is quantified by the maintenance or improvement of ABSIS score while reducing steroid dosage.
No results as study has been terminated early by the investigator."|Expected time line 24 months|This outcome was not assessed because no participant completed any visits of the study|||||
838256|NCT01313936|Secondary|Changes in Standardized Uptake Values on FDG-PET Scans|To describe changes in standardized uptake values (SUVs) obtained by 18FDG-PET scan at study entry and in response to one cycle of protocol therapy.|One year||||||
838257|NCT01313936|Secondary|Changes in Diarrhea|To describe the rate of protocol associated diarrhea according to UGT1A1 genotype.|One year||||||
838258|NCT01313936|Secondary|Therapeutic Response Rate in Patients|To estimate the therapeutic response rate to this regimen according to the NANT modified-version of the International Neuroblastoma Response Criteria.|6 weeks|||Responses|||Number
838259|NCT01313936|Primary|Number of Participants With Dose-limiting Toxicity as a Measure of Tolerability|To determine whether doses of 15 mCi/kg and 18 mCi/kg of 131I-MIBG are tolerable when given with irinotecan/vincristine on a 5-day schedule to children and young adults with high-risk refractory/relapsed neuroblastoma.|6 weeks|||participants with DLT|||Number
838260|NCT01314001|Secondary|Total Side-Effect Severity Index at Week 4|"The mean side-effect severity score by treatment group (placebo vs. nicotine patch vs. varenicline) and by NMR group (slow metabolizers vs. normal metabolizers).
Side-effect severity was calculated using a Side Effects Checklists (SEC). 29 common side-effects associated with transdermal nicotine or varenicline treatment were rated by participants on a 0 (none) to 3 (severe) scale. For each participant at this timepoint, these scores were summed to calculate a total score, with a range of 0 to 87; a higher score indicated a higher severity of side-effects."|Week 4|Intent-to-treat population (all subjects who received at least one dose of intervention).||units on a scale||Standard Deviation|Mean
838261|NCT01314001|Secondary|Total Side-Effect Severity Index at Week 1|"The mean side-effect severity score by treatment group (placebo vs. nicotine patch vs. varenicline) and by NMR group (slow metabolizers vs. normal metabolizers).
Side-effect severity was calculated using a Side Effects Checklists (SEC). 29 common side-effects associated with transdermal nicotine or varenicline treatment were rated by participants on a 0 (none) to 3 (severe) scale. For each participant at this timepoint, these scores were summed to calculate a total score, with a range of 0 to 87; a higher score indicated a higher severity of side-effects."|Week 1|Intent-to-treat population (all subjects who received at least one dose of intervention).||units on a scale||Standard Deviation|Mean
838262|NCT01314001|Secondary|Total Side-Effect Severity Index at Target Quit Date|"The mean side-effect severity score by treatment group (placebo vs. nicotine patch vs. varenicline) and by NMR group (slow metabolizers vs. normal metabolizers).
Side-effect severity was calculated using a Side Effects Checklists (SEC). 29 common side-effects associated with transdermal nicotine or varenicline treatment were rated by participants on a 0 (none) to 3 (severe) scale. For each participant at this timepoint, these scores were summed to calculate a total score, with a range of 0 to 87; a higher score indicated a higher severity of side-effects."|Target Quit Date (Week 0)|Intent-to-treat population (all subjects who received at least one dose of intervention).||units on a scale||Standard Deviation|Mean
838263|NCT01314001|Secondary|Total Side-Effect Severity Index at Pre-Quit|"The mean side-effect severity score by treatment group (placebo vs. nicotine patch vs. varenicline) and by NMR group (slow metabolizers vs. normal metabolizers).
Side-effect severity was calculated using a Side Effects Checklists (SEC). 29 common side-effects associated with transdermal nicotine or varenicline treatment were rated by participants on a 0 (none) to 3 (severe) scale. For each participant at this timepoint, these scores were summed to calculate a total score, with a range of 0 to 87; a higher score indicated a higher severity of side-effects."|Pre-Quit (Week -1/Baseline)|Intent-to-treat population (all subjects who received at least one dose of intervention).||units on a scale||Standard Deviation|Mean
838264|NCT01314001|Secondary|7-day Point Prevalence Quit Rate at 6-month Follow up Survey|The percentage of ITT subjects who were verified as abstinent at the 6-month follow up survey. Abstinence was defined as no self-reported smoking (not even a puff) for at least 7 days before the telephone assessment, with in-person verification for those self-reporting abstinence. In-person verification consisted of breath carbon monoxide analysis, with a reading of 8 parts-per-million or less confirming abstinence. Subjects who were lost to follow-up were considered smokers.|Week 24|Intent-to-treat population (all subjects who received at least one dose of intervention).||percentage of ITT subjects|||Number
838265|NCT01314001|Primary|7-day Point Prevalence Quit Rate at End-of-Treatment (EOT)|The percentage of ITT subjects who were verified as abstinent. Abstinence was defined as no self-reported smoking (not even a puff) for at least 7 days before the telephone assessment, with in-person verification for those self-reporting abstinence. In-person verification consisted of breath carbon monoxide analysis, with a reading of 8 parts-per-million or less confirming abstinence. Subjects who were lost to follow-up were considered smokers.|Week 11|Intent-to-treat population (all subjects who received at least one dose of intervention).||percentage of ITT subjects|||Number
838266|NCT01314014|Secondary|Median Time to Progression Free Survival in Participants With Relapsed/Refractory Indolent and Aggressive Lymphomas|Measured from start of treatment until disease progression or death from any cause.|up to 25 months|20 subjects were evaluable for response, 2 subjects discontinued therapy during cycle 1 due to progressive disease and grade 5 sepsis respectively.||months||Full Range|Median
838386|NCT01309100|Secondary|Comfort Throughout the Day (Investigational vs Air Optix Aqua Lens)|The mean differences in comfort between the investigational lens(RD2117-01) and the Air Optix Aqua control lens. Comfort was measured on a scale of 0 to 100, with 100 being the most favorable score.|1 week|All eligible, dispensed eyes||units on a scale|Participants|Standard Deviation|Least Squares Mean
838267|NCT01314014|Primary|Overall Response Rate of of Participants to Imexon in the Treatment of Relapsed/Refractory Indolent and Aggressive Lymphomas|CT, PET, or MRI scans for the assessment of objective tumor responses were performed at baseline, after cycle 2, and every 3 cycles thereafter until disease progression. Standard response criteria from the International Harmonization Project on Lymphoma were used for classification of objective tumor responses. Response was defined as PR (Regression of measuable disease and no new sites) if >= 50% decrease in sum of the product of the diameters of up to 6 largest dominant masses; no increase in size of other nodes (a) [18F]fluorodeoxyglucose (FDG)-avid or PET prior to therapy; one or more (PET) positive at previously involved site (b) Variably FDG-avid or PET negative; regression on CT.|One year|20 subjects were evaluable for response, 2 subjects discontinued therapy during cycle 1 due to progressive disease and grade 5 sepsis respectively.||percentage of participants||95% Confidence Interval|Number
838268|NCT01314105|Secondary|Change From Baseline in Safety Laboratory Parameters|"Change from baseline in safety laboratory parameters.
As the study is still ongoing, this endpoint has not yet been analysed."|From the first drug administration until 28 days after the last drug administration, up to 50 months|Treated set which included all patients who were administered at least one dose of any study medication|||||
838269|NCT01314105|Secondary|Frequency of All Adverse Events Graded by CTCAE (Common Terminology Criteria for Adverse Events) Version 3.0|"Frequency of all adverse events graded by CTCAE (Common Terminology Criteria for Adverse Events) version 3.0.
As the study is still ongoing, this endpoint has not yet been analysed."|From the first drug administration until 28 days after the last drug administration, up to 50 months|Treated set which included all patients who were administered at least one dose of any study medication|||||
838270|NCT01314105|Secondary|The Maximum Measured Plasma Concentration of Nintedanib|"The maximum measured plasma concentration (Cmax) of nintedanib.
As the study is still ongoing, this endpoint has not yet been analysed."|5 minutes (min) before drug administration and 1 hour (h) 2h, 3h, 4h, 6h, 8h, 10h, 24h, 144h, 312h and 456h after drug administration|PK set|||||
838271|NCT01314105|Secondary|Area Under the Curve of Nintedanib|"Area under the plasma concentration-time curve over the time interval from zero extrapolated to infinity (AUC 0-inf) and area under the plasma concentration-time curve over the time interval from zero to the time of the last quantifiable drug concentration (AUC0-tz) of nintedanib
As the study is still ongoing, this endpoint has not yet been analysed."|5 minutes (min) before drug administration and 1 hour (h) 2h, 3h, 4h, 6h, 8h, 10h, 24h, 144h, 312h and 456h after drug administration|PK set|||||
838272|NCT01314105|Secondary|The Maximum Measured Plasma Concentration of Carboplatin|"The maximum measured plasma concentration of carboplatin (determined as ultrafiltrable and total platinum)
As the study is still ongoing, this endpoint has not yet been analysed."|5 minutes (min) before drug administration and 30 min,59 min, 1 hour (h) 15 min, 1h 29min, 1h 45min, 2h 15min, 2h 45min, 4h, 6h, 7h 30min, 9h, 23h 55min, 25h, 26h, 27h, 28h, 30h, 32h, 34h, 48h, 168h, 336h and 480h after drug administration|PK set|||||
838273|NCT01314105|Secondary|Area Under the Curve of Carboplatin|"Area under the plasma concentration-time curve over the time interval from zero extrapolated to infinity (AUC 0-inf) and area under the plasma concentration-time curve over the time interval from zero to the time of the last quantifiable drug concentration (AUC0-tz) of Carboplatin (determined as ultrafiltrable and total platinum)
As the study is still ongoing, this endpoint has not yet been analysed."|5 minutes (min) before drug administration and 30 min,59 min, 1 hour (h) 15 min, 1h 29min, 1h 45min, 2h 15min, 2h 45min, 4h, 6h, 7h 30min, 9h, 23h 55min, 25h, 26h, 27h, 28h, 30h, 32h, 34h, 48h, 168h, 336h and 480h after drug administration|PK set|||||
838274|NCT01314105|Secondary|The Maximum Measured Plasma Concentration of PLD|"The maximum measured plasma concentration (Cmax) of pegylated liposomal doxorubicin (PLD) (Total Plasma Doxorubicin and Doxorubicinol)
As the study is still ongoing, this endpoint has not yet been analysed."|5 minutes (min) before drug administration and 30 min,59 min, 1 hour (h) 15 min, 1h 29min, 1h 45min, 2h 15min, 2h 45min, 4h, 6h, 7h 30min, 9h, 25h, 27h, 30h, 34h, 48h, 168h, 336h and 480h after drug administration|PK set|||||
838275|NCT01314105|Secondary|Area Under the Curve of PLD|"Area under the plasma concentration-time curve over the time interval from zero extrapolated to infinity (AUC 0-inf) and area under the plasma concentration-time curve over the time interval from zero to the time of the last quantifiable drug concentration (AUC0-tz) of pegylated liposomal doxorubicin (PLD) (total plasma doxorubicin and doxorubicinol)
As the study is still ongoing, this endpoint has not yet been analysed."|5 minutes (min) before drug administration and 30 min,59 min, 1 hour (h) 15 min, 1h 29min, 1h 45min, 2h 15min, 2h 45min, 4h, 6h, 7h 30min, 9h, 25h, 27h, 30h, 34h, 48h, 168h, 336h and 480h after drug administration|Pharmacokinetic set (PK set) which included all patients who were administered at least one dose of any study medication and who were documented to have received at least one dose of Nintedanib and who have at least one valid drug plasma concentration available.|||||
838276|NCT01314105|Primary|Maximum Tolerated Dose of Nintedanib Based on the Occurrence of DLTs During Treatment Course 1|Maximum Tolerated Dose (MTD) of Nintedanib in combination with carboplatin and pegylated liposomal doxorubicin based on the occurrence of dose limiting toxicities (DLTs) during treatment course 1. MTD will be determined among the first 6 evaluable patients in each dose level. MTD is the highest dose at which the incidence of DLT is less than 2/6.|28 days|MTD set which included patients in the dose escalation part of the trial who started treatment course 2 and/or took 1 dose of Carboplatin and PLD, started Nintedanib (Nin) and did not miss more than 13 doses of Nin and/or took 1 dose of Carboplatin and PLD, started Nin and discontinued treatment due to a dose limiting toxicity during the MTD period||participants|||Number
838387|NCT01309100|Primary|Visual Acuity (Investigational vs Acuvue Oasys Lens)|The mean difference in distance high contrast logMAR visual acuity(VA) between the investigational lens(RD2117-01) and the Acuvue Oasys control lens.|1 week|All eligible, dispensed eyes||LogMAR|Participants|Standard Deviation|Least Squares Mean
838281|NCT01314261|Secondary|Percentage of Participants With Extended Rapid Virologic Response (eRVR)|Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Extended RVR was defined as HCV RNA levels < the lower level of quantification (< 25 IU/mL) at Weeks 4 through 12. Data are reported as the percentage of participants with eRVR.|Week 4 through Week 12|All 37 participants enrolled in the study received at least 1 dose of study drug and were included in the intent-to-treat population for efficacy analyses.||percentage of participants|||Number
838282|NCT01314261|Primary|Serum Concentrations of Pegylated Interferon (pegIFN)|Blood samples were collected at each study visit from Week 1 to Week 12. The samples were analyzed for the concentration of pegIFN (measured in ng/mL) using validated analytical methods and pegIFN concentrations in serum were summarized at each visit. Data are reported as the median (range).|At each study visit from Week 1 to Week 12|Participants received at least 1 dose of study drug and had sufficient concentrations to characterize the pharmacokinetic parameters. When a different number of participants at a specific time point was used to analyze the data in the outcome measure, the n (number of participants) for each arm is denoted in the Category Title.||ng/mL||Full Range|Median
838283|NCT01314261|Primary|Plasma Concentrations of Ribavirin (RBV)|Blood samples were collected at each study visit from Week 1 to Week 12. The samples were analyzed for the concentration of RBV (measured in ng/mL) using validated analytical methods and RBV concentrations in plasma were summarized at each visit. Data are reported as the median (range).|At each study visit from Week 1 to Week 12|Participants received at least 1 dose of study drug and had sufficient concentrations to characterize the pharmacokinetic parameters. When a different number of participants at a specific time point was used to analyze the data in the outcome measure, the n (number of participants) for each arm is denoted in the Category Title.||ng/mL||Full Range|Median
838284|NCT01314261|Secondary|Median Time to Suppression of Hepatitis C Virus Ribonucleic Acid (HCV RNA)|Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Time to suppression was defined as the time (measured in days) to HCV RNA levels < the lower limit of quantification (< 25 IU/mL). Data are reported as the median number of days.|Approximately 12 weeks|All 37 participants enrolled in the study received at least 1 dose of study drug and were included in the intent-to-treat population for efficacy analyses.||Days||95% Confidence Interval|Median
838285|NCT01314261|Secondary|Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) Post-pegylated Interferon/Ribavirin (pegIFN/RBV) Dosing|Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Sustained virologic response was defined as HCV RNA levels < the lower limit of quantification (< 25 IU/mL) 24 weeks after the last dose of pegIFN/RBV. Data are reported as the percentage of participants with SVR24.|24 weeks after the last dose of pegIFN/RBV|All 37 participants enrolled in the study received at least 1 dose of study drug and were included in the intent-to-treat population for efficacy analyses.||percentage of participants|||Number
838286|NCT01314261|Secondary|Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-pegylated Interferon/Ribavirin (pegIFN/RBV) Dosing|Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Sustained virologic response was defined as HCV RNA levels < the lower limit of quantification (< 25 IU/mL) 12 weeks after the last dose of pegIFN/RBV. Data are reported as the percentage of participants with SVR12.|12 weeks after the last dose of pegIFN/RBV|All 37 participants enrolled in the study received at least 1 dose of study drug and were included in the intent-to-treat population for efficacy analyses.||percentage of participants|||Number
838287|NCT01314261|Secondary|Percentage of Participants With Complete Early Virologic Response (cEVR)|Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Complete EVR was defined as HCV RNA < the lower limit of quantification (< 25 IU/mL) at Week 12. Data are reported as the percentage of participants with cEVR.|Week 12|All 37 participants enrolled in the study received at least 1 dose of study drug and were included in the intent-to-treat population for efficacy analysis.||percentage of participants|||Number
838388|NCT01309100|Secondary|Comfort Throughout the Day (Investigational vs Acuvue Oasys Lens)|The mean differences in comfort between the investigational lens (RD2117-01) and the Acuvue Oasys control lens. Comfort was measured on a scale of 0 to 100, with 100 being the most favorable score.|1 week|1-Week Follow-up, All Eligible, Dispensed Eyes||units on a scale|Participants|Standard Deviation|Least Squares Mean
838288|NCT01314261|Primary|Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24) Post-dose of ABT-267|Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; prior to dose on Day 2 (24 hours after Day 1 dose); and at each subsequent study visit. The samples were analyzed for the concentration of ABT-267 using validated analytical methods. The area under the plasma concentration -time curve (AUC; measured in ng*hr/mL) is a method of measurement of the total exposure of a drug in blood plasma. The AUC24 of ABT-267 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; prior to dose on Day 2 (24 hours after Day 1 dose); and at each subsequent study visit up to Week 12|Participants received at least 1 dose of study drug and had sufficient concentrations to characterize the pharmacokinetic parameters.||ng*hr/mL||Standard Deviation|Mean
838289|NCT01314261|Primary|Time to Maximum Plasma Concentration (Tmax) of ABT-267|Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-267 using validated analytical methods. The time to maximum plasma concentration (Tmax; measured in hours) is the time it takes for a drug to achieve Cmax. The Tmax of ABT-267 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)|Participants received at least 1 dose of study drug and had sufficient concentrations to characterize the pharmacokinetic parameters.||Hours||Standard Deviation|Mean
838290|NCT01314261|Primary|Maximum Plasma Concentration (Cmax) of ABT-267|Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-267 using validated analytical methods. The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that a drug achieves in the plasma after administration in a dosing interval. The Cmax of ABT-267 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)|Participants received at least 1 dose of study drug and had sufficient concentrations to characterize the pharmacokinetic parameters.||ng/mL||Standard Deviation|Mean
838291|NCT01314261|Secondary|Percentage of Participants With Partial Early Virologic Response (pEVR)|Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Partial EVR was defined as HCV RNA levels that decreased > 2 log10 IU/mL at Week 12 as compared to baseline HCV RNA levels. Data are reported as the percentage of participants with pEVR.|Baseline and Week 12|All 37 participants enrolled in the study received at least 1 dose of study drug and were included in the intent-to-treat population for efficacy analyses.||percentage of participants|||Number
838292|NCT01314261|Primary|Percentage of Participants With 4-week Rapid Virologic Response (RVR)|Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Rapid virologic response was defined as HCV RNA levels < the lower limit of detection (< 15 IU/mL) at Week 4. Data are reported as percentage of participants with RVR.|Week 4|All 37 participants enrolled in the study received at least 1 dose of study drug and were included in the intent-to-treat population for efficacy and safety analyses.||percentage of participants|||Number
838293|NCT01314417|Secondary|Cytokine Analysis on Aqueous Samples to Assess Whether Intravitreal Injection of Methotrexate Affects Aqueous Inflammatory Cytokine Levels||Baseline and Week 74||||||
838294|NCT01314417|Secondary|Observation of Dose Reduction of Systemic Immunosuppression or Steroids Over the Course of the Study Period||Baseline and Week 74||||||
838295|NCT01314417|Secondary|Number of Participants Experiencing a Complete Resolution of Fluid as Seen on OCT at Any Time During the Study Period||Baseline and Week 74|||participants|||Number
838296|NCT01314417|Secondary|Number of Participants Presenting the Same Autofluorescence Patterns in the Study Eye as Seen on Fundus Autofluorescence (FAF) Imaging at Week 24 as Observed at Baseline|"Fundus autofluorescence patterns were assessed using fundus autofluorescence (FAF) imaging, a non-invasive technique that uses a confocal scanning ophthalmoscope to detect naturally-fluorescing lipofuscin.
The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 24|||participants|||Number
838297|NCT01314417|Secondary|Number of Participants Presenting the Same Autofluorescence Patterns in the Study Eye as Seen on Fundus Autofluorescence (FAF) Imaging at Week 12 as Observed at Baseline|"Fundus autofluorescence patterns were assessed using fundus autofluorescence (FAF) imaging, a non-invasive technique that uses a confocal scanning ophthalmoscope to detect naturally-fluorescing lipofuscin.
The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 12|||participants|||Number
838298|NCT01314417|Secondary|Number of Participants Presenting No Change in the Area of Leakage in the Study Eye as Seen on Fluorescein Angiography (FA) Imaging at Week 24 as Compared to Baseline|"Fluorescein angiography (FA) images were obtained via a standard digital imaging system (OIS, Sacramento, CA). Three retinal specialists independently graded the area of late fluorescein leakage (at approximately 10 minutes) in each eye using a region-of-interest tool in an image analysis software package (NIH ImageJ, Bethesda, MD).
The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 24|||participants|||Number
838389|NCT01309100|Primary|Visual Acuity (Investigational vs Air Optix Aqua Lens)|The mean difference in distance high contrast logMAR visual acuity(VA) between the investigational lens (RD2117-01) and the Air Optix Aqua control lens.|1 week|All eligible, dispensed eyes||LogMAR|Participants|Standard Deviation|Least Squares Mean
838299|NCT01314417|Secondary|Number of Participants Presenting No Change in the Area of Leakage in the Study Eye as Seen on Fluorescein Angiography (FA) Imaging at Week 12 as Compared to Baseline|"Fluorescein angiography (FA) images were obtained via a standard digital imaging system (OIS, Sacramento, CA). Three retinal specialists independently graded the area of late fluorescein leakage (at approximately 10 minutes) in each eye using a region-of-interest tool in an image analysis software package (NIH ImageJ, Bethesda, MD).
The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 12|||participants|||Number
838300|NCT01314417|Secondary|Changes in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) in the Study Eye at 20 Weeks Compared to Baseline|"Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.
The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 20|||ETDRS Letters|Participants|Standard Deviation|Mean
838301|NCT01314417|Secondary|Changes in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) in the Study Eye at 24 Weeks Compared to Baseline|"Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.
The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 24|||ETDRS Letters||Standard Deviation|Mean
838302|NCT01314417|Secondary|Changes in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) in the Study Eye at 16 Weeks Compared to Baseline|"Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.
The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 16|||ETDRS Letters|Participants|Standard Deviation|Mean
838303|NCT01314417|Secondary|Changes in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) in the Study Eye at 12 Weeks Compared to Baseline|"Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.
The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 12|||ETDRS Letters|Participants|Standard Deviation|Mean
838304|NCT01314417|Secondary|Changes in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) in the Study Eye at 8 Weeks Compared to Baseline|"Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.
The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 8|||ETDRS Letters|Participants|Standard Deviation|Mean
838305|NCT01314417|Secondary|Changes in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) in the Study Eye at 4 Weeks Compared to Baseline|"Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.
The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 4|||ETDRS Letters|Participants|Standard Deviation|Mean
838306|NCT01314417|Secondary|Change in Optical Coherence Tomography (OCT) Central Macular Thickness in the Study Eye at 24 Weeks Compared to Baseline|"Central-subfield macular thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.
The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 24|||µm|Participants|Standard Deviation|Mean
838307|NCT01314417|Secondary|Change in Optical Coherence Tomography (OCT) Central Macular Thickness in the Study Eye at 20 Weeks Compared to Baseline|"Central-subfield macular thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.
The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 20|||µm|Participants|Standard Deviation|Mean
838308|NCT01314417|Secondary|Change in Optical Coherence Tomography (OCT) Central Macular Thickness in the Study Eye at 16 Weeks Compared to Baseline|"Central-subfield macular thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.
The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 16|||µm|Participants|Standard Deviation|Mean
838309|NCT01314417|Secondary|Change in Optical Coherence Tomography (OCT) Central Macular Thickness in the Study Eye at 12 Weeks Compared to Baseline|"Central-subfield macular thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.
The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 12|||µm|Participants|Standard Deviation|Mean
838310|NCT01314417|Secondary|Change in Optical Coherence Tomography (OCT) Central Macular Thickness in the Study Eye at 8 Weeks Compared to Baseline|"Central-subfield macular thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.
The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 8|||µm|Participants|Standard Deviation|Mean
838311|NCT01314417|Secondary|Change in Optical Coherence Tomography (OCT) Central Macular Thickness in the Study Eye at 4 Weeks Compared to Baseline|"Central-subfield macular thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.
The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 4|||µm|Participants|Standard Deviation|Mean
838312|NCT01314417|Secondary|Change in Optical Coherence Tomography (OCT) Excess Retinal Thickening in the Study Eye at 24 Weeks Compared to Baseline|"Excess retinal thickening was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.
The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 24|||percentage of change from baseline||Standard Deviation|Mean
838313|NCT01314417|Secondary|Change in Optical Coherence Tomography (OCT) Excess Retinal Thickening in the Study Eye at 20 Weeks Compared to Baseline|"Excess retinal thickening was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.
The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 20|||percentage of change from baseline||Standard Deviation|Mean
838314|NCT01314417|Secondary|Change in Optical Coherence Tomography (OCT) Excess Retinal Thickening in the Study Eye at 16 Weeks Compared to Baseline|"Excess retinal thickening was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.
The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 16|||percentage of change from baseline||Standard Deviation|Mean
838315|NCT01314417|Secondary|Change in Optical Coherence Tomography (OCT) Excess Retinal Thickening in the Study Eye at 12 Weeks Compared to Baseline|"Excess retinal thickening was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.
The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 12|||percentage of change from baseline||Standard Deviation|Mean
838316|NCT01314417|Secondary|Change in Optical Coherence Tomography (OCT) Excess Retinal Thickening in the Study Eye at 8 Weeks Compared to Baseline|"Excess retinal thickening was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.
The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 8|||percentage of change from baseline||Standard Deviation|Mean
838805|NCT01313182|Primary|Surgical Site Infections Occurring Within 12 Months of Surgical Procedure|Measure the rate (number and percent of patients) with deep and superficial surgical site infections after primary orthopedic surgery and primary spinal fusion surgery requiring implantation of prosthetic material.|12 months|||participants|||Number
838317|NCT01314417|Secondary|Change in Optical Coherence Tomography (OCT) Excess Retinal Thickening in the Study Eye at 4 Weeks Compared to Baseline|"Excess retinal thickening was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.
The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 4|||percentage of change from baseline||Standard Deviation|Mean
838318|NCT01314417|Primary|Number of Participants Who Meet the Definition of Treatment Success Within 12 Weeks From Baseline.|"Treatment success is defined as achieving at least a 1-step decrease in the LogScore scale for central macular thickness.
A decrease of at least 1-step on the logOCT scale, where Change in logOCT=log(follow-up thickness/200) - log(baseline thickness/200) is considered clinically significant. A 1-step decrease is equivalent to at least a 20% improvement of central macular thickness and represents greater than twice the variability of retinal thickness measurements (approximately 25-30 µ).
Examples of OCT measurements with their corresponding LogScore, where LogScore=10xlogOCT are as follows:
LogScore 0 = OCT 200 µm, LogScore 1 = OCT 250 µm, LogScore 2 = OCT 320 µm, LogScore 3 = OCT 400 µm, LogScore 4 = OCT 500 µm, LogScore 5 = OCT 640 µm, LogScore 6 = OCT 800 µm, LogScore 7 = OCT 1000 µm"|12 weeks|||Participants|||Number
838319|NCT01314443|Secondary|Absolute Change From Baseline in Plasma Malondialdehyde at Day 7 From Day 0.|Plasma measurements of malondialdehyde, a marker of lipid peroxidation was assessed in response to smoking cessation and in combination with gamma-tocopherol (vitamin E) supplementation|Day 0 and 7 of intervention|||microM||Standard Error|Mean
838320|NCT01314443|Secondary|Absolute Change From Baseline in Plasma Gamma-tocopherol (Vitamin E) at Day 7 From Day 0.|Plasma measurements of gamma-tocopherol was assessed in response to smoking cessation and in combination with gamma-tocopherol (vitamin E) supplementation.|Day 0 and 7 of intervention|||microM||Standard Error|Mean
838321|NCT01314443|Primary|Absolute Change in Brachial Artery Flow-mediated Dilation at Day 7 From Day 0|Flow-mediated dilation (FMD) of the brachial artery is measured to assess vascular endothelial function. FMD is obtained by monitoring change in vessel diameter before and after brachial artery occlusion with a blood pressure cuff. The unit of FMD is % and is calculated using the following equation: FMD = [(peak dilation at post occlusion - vessel diameter at preocclusion)/vessel diameter at preocclusion]*100.|Day 0 and 7 of intervention|Analysis was performed on all participants completing the 7 d intervention||% of preocclusion diameter||Standard Error|Mean
838322|NCT01314703|Primary|Antimicrobial Efficacy Will be Measured by the Change (+/-) in Bacterial Count on the Skin 10 Minutes After a Single Application of Test Material Relative to the Baseline Bacterial Count.|the measure of antimicrobial efficacy was calculated by subtracting the 10 minute post test material application bacterial recovery from the baseline bacterial recovery.|10 minutes after single application of test material|27 subjects were treated with ChloraPrep on the abdomen and groin treatment sites. 26 of the 27 abdomen sites met the qualifying bacterial baseline count and were included in the analysis. 25 of the groin sites met the qualifying bacterial baseline count and were included in the analysis.||log 10 colony forming units||95% Confidence Interval|Mean
838323|NCT01314716|Secondary|Time to Protocol-Defined Exacerbation (PDE)|"Protocol-defined exacerbation was defined as an acute worsening of respiratory disease that triggered the initiation of a non-study antibiotic meeting at least 3 major criteria, or 2 major and at least 2 minor criteria.
Major Criteria: increased sputum production; increased discoloration of sputum; increased dyspnea; increased cough
Minor Criteria: fever (> 38º C) measured during clinic visit; increased malaise or fatigue; forced expiratory volume in 1 second (FEV1) (L) or forced vital capacity (FVC) decreased > 10% from baseline; new or increased hemoptysis"|Baseline to Day 112|ITT Analysis Set||days||95% Confidence Interval|Median
838324|NCT01314716|Secondary|Change in QOL-B Respiratory Symptoms Score at Day 84|The mean (SD) change in the Respiratory Symptoms score on the QOL-B was measured from baseline to the end of Course 2 (Day 84). The QOL-B respiratory symptoms score was transformed onto a scale of 0-100, with higher scores representing a better quality of life.|Baseline to Day 84|Participants in the ITT Analysis Set with scores at both baseline and Day 84 were analyzed.||units on a scale||Standard Deviation|Mean
838325|NCT01314716|Primary|Change in QOL-B Respiratory Symptoms Score at Day 28|The mean (SD) change in the Respiratory Symptoms score on the Quality of Life Questionnaire-Bronchiectasis (QOL-B) was measured from baseline to the end of Course 1 (Day 28). The QOL-B respiratory symptoms score was transformed onto a scale of 0-100, with higher scores representing a better quality of life.|Baseline to Day 28|Participants in the ITT Analysis Set with scores at both baseline and Day 28 were analyzed.||units on a scale||Standard Deviation|Mean
838326|NCT01314742|Primary|Duration of Mechanical Ventilation|Time on invasive mechanical ventilation will be measured in days|3 days|||ventilator-days||Standard Deviation|Mean
838327|NCT01314742|Primary|Feasibility|percentage of participants with retention|duration of study, for up to 30 months|||percentage of participants retained|||Number
838328|NCT01314872|Secondary|Extension Study: Change From Baseline in Average Daily Number of Strong Urge Episodes at Week 52|Participants were required to keep a voiding diary, recording the occurrence of each strong urge episode. The average daily number of strong urge episodes was calculated as the total number of times a participant experienced such an episode during 52-week Extension Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the value at Week 0 of the Base Study.|Baseline and Week 52 of Extension Study|Full analysis set population included all randomized participants who received at least one dose of study treatment and have either baseline data or at least one post-randomization observation for the analysis endpoint.||Strong urge episodes||95% Confidence Interval|Least Squares Mean
838338|NCT01314872|Primary|Base Study/Part 1 + Part 2: Number of Participants Who Experienced an Adverse Event (AE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.|Part 1: up to 8 weeks; Part 2: up to 4 weeks. The time frame was an additional 2 weeks for participants not continuing to the Extension Study.|All participants as treated population consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received.||Participants|||Number
838329|NCT01314872|Secondary|Extension Study: Change From Baseline in Average Daily Number of Total Incontinence Episodes at Week 52|Participants were required to keep a voiding diary, recording the occurrence of each total incontinence episode. The average daily number of total incontinence episodes was calculated as the total number of times a participant experienced such an episode during 52-week Extension Study, divided by the total divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the value at Week 0 of the Base Study.|Baseline and Week 52 of Extension Study|Full analysis set population included all randomized participants who received at least one dose of study treatment and have either baseline data or at least one post-randomization observation for the analysis endpoint. This outcome measure included OAB Wet participants only.||Incontinence episodes||95% Confidence Interval|Least Squares Mean
838330|NCT01314872|Secondary|Extension Study: Change From Baseline in Average Daily Number of Urge Incontinence Episodes at Week 52|Participants were required to keep a voiding diary, recording the occurrence of each urge incontinence episode. The average daily number of urge incontinence episodes was calculated as the total number of times a participant experienced such an episode during 52-week Extension Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the value at Week 0 of the Base Study.|Baseline and Week 52 of Extension Study|Full analysis set population included all randomized participants who received at least one dose of study treatment and have either baseline data or at least one post-randomization observation for the analysis endpoint. This outcome measure included OAB Wet participants only.||Urge incontinence episodes||95% Confidence Interval|Least Squares Mean
838331|NCT01314872|Secondary|Extension Study: Change From Baseline in Average Daily Micturitions at Week 52|Participants were required to keep a voiding diary, recording the daily occurrence of each micturition. The average daily number of micturitions was calculated as the total number of recorded micturitions that occurred during the 52-week Extension Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the value at Week 0 of the Base Study.|Baseline and Week 52 of Extension Study|Full analysis set population included all randomized participants who received at least one dose of study treatment and have either baseline data or at least one post-randomization observation for the analysis endpoint.||Micturitions||95% Confidence Interval|Least Squares Mean
838332|NCT01314872|Secondary|Base Study/Part 1: Change From Baseline in Average Daily Number of Strong Urge Episodes at Week 8|Participants were required to keep a voiding diary, recording the occurrence of each strong urge episode. The average daily number of strong urge episodes was calculated as the total number of times a participant experienced such an episode over a week (4 to 10 days) during the Base Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the average daily number of strong urge episodes that occurred during the week of placebo run-in prior to Week 0 visit.|Baseline and Week 8|Full analysis set population included all randomized participants who received at least one dose of study treatment and have either baseline data or at least one post-randomization observation for the analysis endpoint.||Strong urge episodes||95% Confidence Interval|Least Squares Mean
838333|NCT01314872|Secondary|Base Study/Part 1: Change From Baseline in Average Daily Number of Total Incontinence Episodes at Week 8|Participants were required to keep a voiding diary, recording the occurrence of each total incontinence episode. The average daily number of total incontinence episodes was calculated as the total number of times a participant experienced such an episode over a week (4 to 10 days) during the Base Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the average daily number of total incontinence episodes that occurred during the week of placebo run-in prior to Week 0 visit.|Baseline and Week 8|Full analysis set population included all randomized participants who received at least one dose of study treatment and have either baseline data or at least one post-randomization observation for the analysis endpoint. This outcome measure included OAB Wet participants only.||Incontinence episodes||95% Confidence Interval|Least Squares Mean
838334|NCT01314872|Secondary|Base Study/Part 1: Change From Baseline in Number of Urge Incontinence Episodes at Week 8|Participants were required to keep a voiding diary, recording the occurrence of each total incontinence episode. The average daily number of total incontinence episodes was calculated as the total number of times a participant experienced such an episode over a week (4 to 10 days) during the Base Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the average daily number of total incontinence episodes that occurred during the week of placebo run-in prior to Week 0 visit.|Baseline and Week 8|Full analysis set population included all randomized participants who received at least one dose of study treatment and have either baseline data or at least one post-randomization observation for the analysis endpoint. This outcome measure included OAB Wet participants only.||Urge incontinence episodes||95% Confidence Interval|Least Squares Mean
838335|NCT01314872|Primary|Extension Study: Number of Participants Who Had Study Medication Withdrawn Due to an AE|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.|Extension: up to 52 weeks|All participants as treated population consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received.||Participants|||Number
838336|NCT01314872|Primary|Extension Study: Number of Participants Who Experienced an Adverse Event (AE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.|Extension: up to 54 weeks (including 2-week follow-up)|All participants as treated population consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received.||Participants|||Number
838337|NCT01314872|Primary|Base Study/Part 1 + Part 2: Number of Participants Who Had Study Medication Withdrawn Due to an AE|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.|Part 1: up to 8 weeks; Part 2: up to 4 weeks|All participants as treated population consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received.||Participants|||Number
838339|NCT01314872|Primary|Base Study/Part 1: Change From Baseline in Average Daily Micturitions at Week 8|Participants were required to keep a voiding diary, recording the occurrence of each micturition. The average daily number of micturitions was calculated as the total number of micturitions that occurred over a week (4 to 10 days) during the Base Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the average daily number of daily micturitions that occurred during the week of placebo run-in prior to Week 0 visit.|Baseline and Week 8|Full analysis set population included all randomized participants who received at least one dose of study treatment and have either baseline data or at least one post-randomization observation for the analysis endpoint.||Micturitions||95% Confidence Interval|Least Squares Mean
838340|NCT01315002|Primary|Error Percentage in Antisaccade Task|Three hours after the application of a nicotine or a placebo patch, performance on the antisaccade task is assessed. In the antisaccade task participants visually fixate a central stimulus which is replaced by a sudden onset target that appears at some distance to the left or right. Participants are told to refrain from looking at the peripheral target, and direct their gaze instead in the opposite direction (i.e. they have to make an antisaccade). Participants typically fail to achieve this on a significant number of trials and instead make reflexive glances towards the target (i.e. making a so-called antisaccade error). Error percentage in the antisaccade task is the unit of measure in this task. Error percentage in the antisaccade task = number of antisaccade errors / total number of trials.|Three hours after patch application|||Error Percentage in Antisaccade Task||Standard Deviation|Mean
838341|NCT01315028|Secondary|Global Assessment of Functioning (GAF)|Participant functioning was assessed using the Global Assessment of Functioning (GAF) (APA, 1987). The Global Assessment of Functioning (GAF) is a numeric scale (0 through 100) used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of adults, e.g., how well or adaptively one is meeting various problems-in-living, with higher score indicating higher functioning. The score is often given as a range, from 1 - 10 Persistent danger of severely hurting self or others (e.g., recurrent violence) or persistent inability to maintain minimal personal hygiene or serious suicidal act with clear expectation of death, to 91 - 100 No symptoms. Superior functioning in a wide range of activities, life's problems never seem to get out of hand, is sought out by others because of his or her many positive qualities.|monthly until October 2011|||units on a scale||Standard Deviation|Mean
838342|NCT01315028|Secondary|The Internal State Scale (ISS) (Bauer et al, 1991)|"The Internal State Scale (ISS) (Bauer et al, 1991) is a 15 item self-report scale that utilizes 100 mm visual analogue scales to assess the presence and severity of symptoms, ranging from 'not at all / rarely' to 'very much so / much of the time' (score range per item 0 to 100). The ISS assesses depressive and hypomanic / manic symptoms across four factors: perceived conflict, activation, well-being and depression. Perceived Conflict is assessed across 5 items (score range 0 to 500), Activation across 5 items (score range 0 to 500), Well-being across 3 items (score range 0 to 300) and Depression across 2 items (score range 0 to 200).
The Well-being subscale is used in conjunction with the Activation subscale for mood state discrimination. The suggested scoring algorithm is as follows:
Mood State Activation Subscale Score Well-Being Subscale Score (Hypo)Mania >155 >125 Mixed State >155 <125 Euthymia <155 >125 Depression <155"|monthly until October 2011|||units on a scale||Standard Deviation|Mean
838343|NCT01315028|Primary|Bech-Rafaelsen Mania Rating Scale (BRMS) [Bech et al, 1979]|"The Bech-Rafaelsen Mania Rating Scale (BRMS) [Bech et al, 1979] provides a structured format for a clinician to assess the presence and severity of 11 core symptoms of hypomania or mania.Higher BRMS score indicates more severe symptoms of mania, and each item yields a score of 0 to 4. The overall score ranges from 0 to 44. Usual cutoff points are:
0 to 15 – normal /symptom absent 15 to 20 – mild 21 to 28 – moderate >34 – severe"|Baseline to End of Study|||units on a scale||Standard Deviation|Mean
838344|NCT01315028|Primary|Montgomery Asberg Depression Rating Scale (MADRS) (Montogomery and Asberg, 1979)|"The Montgomery Asberg Depression Rating Scale (MADRS) (Montgomery and Asberg, 1979) is a semi-structured interview designed to assess the presence and severity of 10 core symptoms of depression. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.
The questionnaire includes questions on the following symptoms 1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts. Usual cutoff points are:
0 to 6 – normal /symptom absent 7 to 19 – mild depression 20 to 34 – moderate depression >34 – severe depression"|Baseline to End of Study.|||units on a scale||Standard Deviation|Mean
838345|NCT01315145|Primary|Percentage of Participants With a 2-point Improvement in Visual Analogue Scale|The primary endpoint for evaluating effectiveness will be the proportion of subjects in each group achieving at least a 2-point improvement from baseline in the Visual Analog Scale.|16 weeks|All participants who reported 16 week outcomes are included in this analysis.||percentage of responders|||Number
838346|NCT01315158|Secondary|Number of Participants Who Experience Symptoms of Nausea and Vomiting Will be Compared Between the Two Groups|The number of participants who experience symptoms of nausea and vomiting in the two groups of patients will be recorded. This will be recorded during the follow-up phone call made 24-48 hours after the procedure.|24-48 hours|||participants|||Number
838347|NCT01315158|Secondary|Patient Tolerance as Assessed by Endoscopists|The frequency of symptoms of nausea and vomiting in the two groups of patients will be recorded. Patient tolerance of the procedure will be assessed independently by the endoscopist using a 100-mm visual analog scale (VAS, 0=unmanageable, 100=excellent). The patient will also score the level of tolerance using the same VAS at a routine follow-up phone call made 24-48 hours after the procedure.|24-48 hours|The data for this outcome measure was not collected and was not analyzed due to not having the necessary support to continue the study.|||||
838348|NCT01315158|Secondary|Predictors of Sedation Related Complications as Measured by Early Procedure Termination for an Alternative Sedation Related Complication||One year|||incidences|||Number
838349|NCT01315158|Secondary|Predictors of Sedation Related Complications as Measured by the Incidences of Hypotension (Defined as Systolic Blood Pressure of Less Than 90mmHg or a Decrease of More Than 25% From Baseline)||One year|||incidences|||Number
838350|NCT01315158|Secondary|Predictors of Sedation Related Complications as Measured by Hypopnea/Apnea (Defined as Fewer Than 6 Breaths/Minute Based on Capnography)||One year|||incidences|||Number
838356|NCT01315249|Secondary|Inspiratory Capacity (IC) at All-time Points (26 Weeks)|After 26 weeks of treatment, Inspiratory Capacity (IC) was measured via spirometry, conducted according to internationally accepted standards. The mean of 3 acceptable measurements was calculated and reported in liters.|26 weeks|"Inspiratory capacity was measured for a subset of patients QVA149 group: (78 patients (30.2%)) at baseline and 49-73 patients contributing observations at post-baseline visits.
flut/salm group: (86 patients (32.6%)) at baseline and 60-79 patients contributing observations at post-baseline visits."||Liters||Standard Error|Least Squares Mean
838357|NCT01315249|Secondary|Inspiratory Capacity (IC) at All-time Points (12 Weeks)|After 12 weeks of treatment, Inspiratory Capacity (IC) was measured via spirometry, conducted according to internationally accepted standards. The mean of 3 acceptable measurements was calculated and reported in liters.|12 weeks|"Inspiratory capacity was measured for a subset of patients QVA149 group: (78 patients (30.2%)) at baseline and 49-73 patients contributing observations at post-baseline visits.
flut/salm group: (86 patients (32.6%)) at baseline and 60-79 patients contributing observations at post-baseline visits."||Liters||Standard Error|Least Squares Mean
838358|NCT01315249|Secondary|Change From Baseline in Symptom Scores Reported Using the Ediary|"Participants maintained an ediary to record daily symptom scores (AM and PM) over 12 weeks and 26 weeks of treatment. This analysis compares the mean symptom scores over 12 weeks and 26 weeks compared to baseline. The diary records morning and evening daily clinical symptoms including cough, wheezing, shortness of breath, sputum volume, sputum purulence, night time awakenings and rescue medication use.
Scale ranges: ranges are 0 to 3 with varying scale descriptions that pertain to the question being asked.
0 is the minimum score = “none” or “No symptoms” or “never” or “No”
= mild, a little
= moderate
= severe For the scale range provided, high values represent a worse outcome."|12 weeks and 26 weeks|The Full Analysis Set (FAS) includes all randomized patients who received at least one dose of study drug. FAS were used to analyze all efficacy endpoints, unless otherwise stated. Following the intention-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to.||units on a scale||Standard Error|Least Squares Mean
838359|NCT01315249|Secondary|Mean Change From Baseline in Daily Number of Puffs of Rescue Medication|Participants maintained a diary to record the daily number of puffs of rescue medication used to treat COPD symptoms.|Baseline, 12 weeks and 26 weeks|The Full Analysis Set (FAS) includes all randomized patients who received at least one dose of study drug. FAS were used to analyze all efficacy endpoints, unless otherwise stated. Following the intention-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to.||puffs||Standard Error|Least Squares Mean
838360|NCT01315249|Secondary|Total Score of the St. George's Respiratory Questionnaire (SGRQ-C)|The total score of the St. George's Respiratory Questionnaire (SGRQ-C) is a health related quality of life questionnaire consisting of 51 items in three components: symptoms, activity, and impacts. The lowest possible value is zero and the highest 100. Higher values correspond to greater impairment in quality of life.|12 weeks and 26 weeks|The Full Analysis Set (FAS) includes all randomized patients who received at least one dose of study drug. FAS were used to analyze all efficacy endpoints, unless otherwise stated. Following the intention-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to.||units on a scale||Standard Error|Least Squares Mean
838361|NCT01315249|Secondary|Focal Score of the Transitional Dyspnea Index (TDI)|Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement.|12 weeks and 26 weeks|The Full Analysis Set (FAS) includes all randomized patients who received at least one dose of study drug. FAS were used to analyze all efficacy endpoints, unless otherwise stated. Following the intention-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to.||units on a scale||Standard Error|Least Squares Mean
838362|NCT01315249|Secondary|Forced Vital Capacity at All-time Points (Week 26)|"Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed via spirometry. A positive change from baseline in FVC indicates improvement in lung function.
This outcome measures absolute values at -45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose on week 26. Results are obtained from linear mixed model."|-45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose on week 26|The Full Analysis Set (FAS) includes all randomized patients who received at least one dose of study drug. FAS were used to analyze all efficacy endpoints, unless otherwise stated. Following the intention-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to.||liters||Standard Error|Least Squares Mean
838363|NCT01315249|Secondary|Forced Vital Capacity at All-time Points (Week 12)|"Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed via spirometry. A positive change from baseline in FVC indicates improvement in lung function.
This outcome measures absolute values at -45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose week 12. Results are obtained from linear mixed model."|-45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose on week 12|The Full Analysis Set (FAS) includes all randomized patients who received at least one dose of study drug. FAS were used to analyze all efficacy endpoints, unless otherwise stated. Following the intention-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to.||liters||Standard Error|Least Squares Mean
838364|NCT01315249|Secondary|Standardized Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12 Hours|Standardized Forced Expiratory Volume in 1 Second (FEV1) was measured with spirometry conducted according to internationally accepted standards. Measurements were made between 0 and 12 hours after treatment. FEV1 was normalized by 12 hours (divided by time). This outcome measures absolute values at week 12. Results are obtained from linear mixed model.|Week 12|The Full Analysis Set (FAS) includes all randomized patients who received at least one dose of study drug. FAS were used to analyze all efficacy endpoints, unless otherwise stated. Following the intention-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to.||liters||Standard Error|Least Squares Mean
840534|NCT01336894|Primary|3-year Overall Survival (OS) Rate|Overall survival is defined as the time from randomization until death from any cause.|Up to 3 years post-randomization|Study terminated prematurely. Planned analyses was not performed due to the nature of the closure endpoint data is not available.|||||
838365|NCT01315249|Primary|Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12|Forced Expiratory Volume in one second (FEV1) was calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. FEV1 was normalized by 12 hours (divided by time). This outcome measures absolute values at week 26. Results are obtained from linear mixed model.|Week 26|The Full Analysis Set (FAS) included all randomized patients who received at least one dose of study drug. FAS were used to analyze all efficacy endpoints, unless otherwise stated. Following the intention-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to.||liters||Standard Error|Least Squares Mean
838366|NCT01315574|Secondary|Tear Film Break-Up Time|Tear Film Break-Up Time (TBUT) is a clinical test used to quantify changes in dry eye symptoms. The Tear Film Break-Up time is the number of seconds between the subjects last blink and the detection of the first dry spot in the tear film.|At the 6 month follow-up time point|Two subjects in each arm/group did not complete 6-month follow up visit. Data was not collected and analysis not completed.||Seconds||Standard Deviation|Mean
838367|NCT01315574|Secondary|Corneal Fluorescein Staining Score|Corneal Fluorescein Staining score was used in this study to quantify changes in dry eye symptoms. Corneal fluorescein staining scores range from 0 to 4 points: 0=non-staining to 4 =regional whole staining of the cornea. Higher scores indicate worse eye condition.|At the 6 month follow-up time point|Two subjects in each arm/group did not complete 6-month follow up visit. Data was not collected and analysis not completed.||units on a scale (1-4)||Standard Deviation|Mean
838368|NCT01315574|Primary|Effectiveness in Lowering Intraocular Pressure|Applanation tonometry will be used to measure patients' intraocular pressure|At the 6 month follow-up time point|Two subjects in each arm/group did not complete 6-month follow up visit. Data was not collected and analysis not completed.||mmHg||Standard Deviation|Mean
838369|NCT01315665|Secondary|Measure of Neutrophil Migration Into the Gingival Crevices|Change in gingival neutrophils measured after 5 days of study treatment (consuming broccoli sprouts). Patients will perform mouthwashes with normal saline. Neutrophil counts will be performed on fresh samples. Acridine orange will be added to the saline rinses and neutrophils will be counted under the microscope.|Baseline and end of 5 day treatment period|||Neutrophils/mL (Log10)||Standard Deviation|Mean
838370|NCT01315665|Secondary|Measures of Oxidative Stress in Urine|Change in urine bromotyrosine (measured by mass spectrometry) will be measured after 5 days of study treatment (consuming broccoli sprouts).|Baseline and end of 5 day treatment period|||ng/mg creatinine (Log10)||Standard Deviation|Mean
838371|NCT01315665|Secondary|Measures of Glutathione From Blood Lymphocytes|Change in lymphocyte glutathione measurements after 5 days of study treatment (consuming broccoli sprouts).|Baseline and end of 5 day treatment period|Not enough blood could be obtained from one of the healthy volunteers. Therefore, glutathione from blood lymphocytes could not be evaluated from that healthy volunteer. With respect to this outcome measure, only results from 9 healthy volunteers are reported.||Micro Molar||Standard Deviation|Mean
838372|NCT01315665|Secondary|Measures of Lipid Peroxidation in Nasal Epithelial Cells|Products of lipid peroxidation will be determined by western blot analysis on nasal epithelial cells obtained by curettage after 5 days of study treatment (consuming broccoli sprouts)|End of 5 day treatment period|Data not collected and will not be analyzed.|||||
838373|NCT01315665|Primary|Nrf2 Activation in Nasal Epithelial Cells|Number of subjects with activated Nrf-2 in the cytoplasm of nasal epithelial cells after 5 days of study treatment (consuming broccoli sprouts)|Baseline and of end of 5 day treatment period|||participants|||Number
838374|NCT01315847|Primary|Brain CGRP RO Post Telcagepant Obtained by PET Imaging Using [11C]MK-4232 Tracer at Baseline and After a Therapeutic Dose of Telcagepant (140 mg) in Participants With Migraine During Period When Migraine is Absent (Interictal Phase)(Part III, Period 2)|Brain CGRP RO post telcagepant was determined by change in [11C]MK-4232 PET tracer biokinetics at baseline and post telcagepant administration. Using PET brain images acquired over ~0-90 minutes after [11C]MK-4232 dose, ROIs were drawn throughout the cerebral cortex and white matter, striatum, thalamus, cerebellum and pons. The ROIs were projected onto all frames of the dynamic PET scans in order to generate [11C]MK-4232 tissue TACs. Serial arterial blood samples for measurement of plasma radioactivity and [11C]MK-4232 concentrations were collected during the PET scans. These samples provided the arterial input function for a two-tissue compartmental model of [11C]MK-4232 tracer biokinetics. VT, an index of receptor density, was estimated by fitting the two-tissue compartmental model to the PET [11C]MK-4232 TACs. The change in VT between the baseline and post telcagepant PET studies was used to quantify the brain CGRP RO.|Part III, Period 2 Baseline, at ~0-90 minutes after [11C]MK-4232 dose; and Part III, Period 2 post telcagepant, at ~0-90 minutes after [11C]MK-4232 dose|Results could not be obtained for this measure. For Part III data, the curve fits were unsatisfactory (model curves did not pass through the TAC data points) precluding the quantification of the VT and RO|||||
838375|NCT01315847|Primary|Brain CGRP RO Post Telcagepant Obtained by PET Imaging Using [11C]MK-4232 Tracer at Baseline and After a Therapeutic Dose of Telcagepant (140 mg) in Participants With Migraine During a Migraine Attack (Ictal Phase)(Part III, Period 1)|Brain CGRP RO post telcagepant was determined by change in [11C]MK-4232 PET tracer biokinetics at baseline and post telcagepant administration. Using PET brain images acquired over ~0-90 minutes after [11C]MK-4232 dose, ROIs were drawn throughout the cerebral cortex and white matter, striatum, thalamus, cerebellum and pons. The ROIs were projected onto all frames of the dynamic PET scans in order to generate [11C]MK-4232 tissue TACs. Serial arterial blood samples for measurement of plasma radioactivity and [11C]MK-4232 concentrations were collected during the PET scans. These samples provided the arterial input function for a two-tissue compartmental model of [11C]MK-4232 tracer biokinetics. VT, an index of receptor density, was estimated by fitting the two-tissue compartmental model to the PET [11C]MK-4232 TACs. The change in VT between the baseline and post telcagepant PET studies was used to quantify the brain CGRP RO.|Part III, Period 1 Baseline, at ~0-90 minutes after [11C]MK-4232 dose; and Part III, Period 1 post telcagepant, at ~0-90 minutes after [11C]MK-4232 dose|Results could not be obtained for this measure. For Part III data, the curve fits were unsatisfactory (model curves did not pass through the TAC data points) precluding the quantification of the VT and RO|||||
838439|NCT01316224|Secondary|Percentage of Participants With Joint Symptoms|Joint symptoms were evaluated by presence or absence of peripheral arthritis, morning stiffness and participant reported joint symptoms.|At Baseline, Visit 3 (month 6) and Visit 4 (month 12)|Participants who completed the visits (visit 3 and visit 4) to the rheumatologist and for whom information was available.||Percentage of participants|||Number
838376|NCT01315847|Primary|Average Telcagepant Plasma Concentration During PET Imaging Using [11C]MK-4232 Tracer After a Therapeutic Dose of Telcagepant (140 mg) in Healthy Participants (Part I, Period 2)|In Part I, Period 2 blood samples for determination of plasma telcagepant concentrations were obtained prior to the telcagepant dose (time 0) and at 1, 2, 3 and 4 hours post telcagepant dose. The average plasma telcagepant concentration during the PET scan was determined, calculated as the area under the plasma telcagepant concentration versus time curve during the PET scanning interval divided by the duration of the PET scanning interval.|Part 1, Period 2 post telcagepant, at ~0-90 minutes after [11C]MK-4232 dose|Participants who received both telcagepant and [11C]MK-4232 during Part I, Period 2 of study, had evaluable data and were compliant with the the study protocol||μM||Standard Deviation|Mean
838377|NCT01315847|Primary|Brain CGRP RO Post Telcagepant Obtained by PET Imaging Using [11C]MK-4232 Tracer at Baseline and After a Therapeutic Dose of Telcagepant (140 mg) in Healthy Participants (Part I, Period 2)|Brain CGRP RO post telcagepant was determined by change in [11C]MK-4232 PET tracer biokinetics at baseline and post telcagepant administration. Using PET brain images acquired over ~0-90 miniutes after [11C]MK-4232 dose, ROIs were drawn throughout the cerebral cortex and white matter, striatum, thalamus, cerebellum and pons. The ROIs were projected onto all frames of the dynamic PET scans in order to generate [11C]MK-4232 tissue TACs. Serial arterial blood samples for measurement of plasma radioactivity and [11C]MK-4232 concentrations were collected during the PET scans. These samples provided the arterial input function for a two-tissue compartmental model of [11C]MK-4232 tracer biokinetics. VT, an index of receptor density, was estimated by fitting the two-tissue compartmental model to the PET [11C]MK-4232 TACs. The change in VT between the baseline and post telcagepant PET studies was used to quantify the brain CGRP RO.|Part I Baseline, at ~0-90 minutes after [11C]MK-4232 dose; and Part I, Period 2 post telcagepant, at ~0-90 minutes after [11C]MK-4232 dose|Participants who received both telcagepant and [11C]MK-4232 during Part I, Period 2 of study, had evaluable data and were compliant with the the study protocol||percent CGRP RO|||Number
838378|NCT01315847|Primary|Average Telcagepant Plasma Concentration During PET Imaging Using [11C]MK-4232 Tracer After a Maximum Dose of Telcagepant (1120 mg) in Healthy Participants (Part I, Period 1)|In Part I, Period 1 blood samples for determination of plasma telcagepant concentrations were obtained prior to the telcagepant dose (time 0) and at 2, 3, 4 and 5 hours post telcagepant dose. The average plasma telcagepant concentration during the PET scan was determined, calculated as the area under the plasma telcagepant concentration versus time curve during the PET scanning interval divided by the duration of the PET scanning interval.|Part I, Period 1 post telcagepant, at ~0-90 minutes after [11C]MK-4232 dose|Participants who received both telcagepant and [11C]MK-4232 during Part I, Period 1 of study, had evaluable data and were compliant with the the study protocol||μM||Standard Deviation|Mean
838379|NCT01315847|Primary|Brain Calcitonin Gene-related Peptide (CGRP) Receptor Occupancy (RO) Post Telcagepant Obtained by PET Imaging Using [11C]MK-4232 Tracer at Baseline and After a Maximum Dose of Telcagepant (1120 mg) in Healthy Participants (Part I, Period 1)|Brain CGRP RO post telcagepant was determined by change in [11C]MK-4232 PET tracer biokinetics at baseline and post telcagepant administration. Using PET brain images acquired over ~0-90 minutes after [11C]MK-4232 dose, regions of interest (ROIs) were drawn throughout cerebral cortex and white matter, striatum, thalamus, cerebellum and pons. The ROIs were projected onto all frames of the dynamic PET scans in order to generate [11C]MK-4232 tissue time-activity curves (TACs). Serial arterial blood samples for measurement of plasma radioactivity and [11C]MK-4232 concentrations were collected during the PET scans. These samples provided the arterial input function for a two-tissue compartmental model of [11C]MK-4232 tracer biokinetics. Total volume of distribution (VT), an index of receptor density, was estimated by fitting the two-tissue compartmental model to the PET [11C]MK-4232 TACs. Change in VT between baseline and post telcagepant PET studies was used to quantify the brain CGRP RO.|Part I Baseline, at ~0-90 minutes after [11C]MK-4232 dose; and Part I, Period 1 post telcagepant, at ~0-90 minutes after [11C]MK-4232 dose|Participants who received both telcagepant and [11C]MK-4232 during Part I, Period 1 of study, had evaluable data and were compliant with the the study protocol||percent CGRP RO|||Number
838380|NCT01315847|Primary|Number of Participants With AEs (Part III)|Any AEs occurring among participants (all were migraine patients) in Part III of study were recorded. An AE was defined as any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the administration of the study drug, was also an AE.|Up 14 days after the last dose of telcagepant and/or [11C]MK-4232 in Part III of study (Up to approximately 6 months)|All participants who received at least one dose of study medication (telcagepant and/or [11C]MK-4232) in Part III of study.||participants|||Number
838381|NCT01315847|Primary|Number of Participants With Adverse Events (AEs) (Part I)|Any AEs occurring among participants (all were healthy subjects) in Part I of study were recorded. An AE was defined as any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the administration of the study drug, was also an AE.|Up 14 days after the last dose of telcagepant and/or [11C]MK-4232 in Part I of study (Up to approximately 14 weeks)|All participants who received at least one dose of study medication (telcagepant and/or [11C]MK-4232) in Part I of study.||participants|||Number
838382|NCT01316042|Primary|Change in Serum DHEAS Levels|Change in DHEAS level was constructed per subject as the 1-year measurement minus the baseline measurement. Only descriptive statistics are provided, statistical tests were not conducted given the extremely small sample size per group.|1 year|||ug/dL||Full Range|Mean
838383|NCT01316055|Secondary|The Steady State Fractional Clearance, Calculated as the Dose / AUC(0-12) (CL/Fss) of Dalfampridine-ER 7.5 mg Tablets in Healthy Adult Volunteers and Those With Mild and Moderate Renal Impairment and Examine Between-group Differences.||7 days|ITT||liter/hour||90% Confidence Interval|Geometric Mean
838384|NCT01316055|Secondary|The Maximum Measured Plasma Concentration (Cmax) at Steady State, of Dalfampridine-ER 7.5 mg Tablets in Healthy Adult Volunteers and Those With Mild and Moderate Renal Impairment and Examine Between-group Differences.||7 days|ITT||nanogram/milliliter||90% Confidence Interval|Geometric Mean
838390|NCT01309204|Primary|Mean Diurnal IOP Change From Baseline at Month 3|Mean Diurnal IOP Change from Baseline at Month 3 (ie, the subject IOP change from baseline averaged over the 9 AM and + 2 h time points at Month 3) was measured by Goldmann applanation tonometry. The study drug was instilled approximately 15 minutes after conducting the 9AM IOP measurement. One eye from each subject was chosen as the study eye, and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).|Baseline (Day 1), Month 3|Per Protocol (PP): All subjects who received study medication, satisfied prerandomization inclusion/exclusion criteria, and completed at least 1 scheduled on-therapy study visit. In addition, individual subject visits and data points that did not satisfy the protocol criteria may have been excluded.||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
838391|NCT01309243|Secondary|Development of HIV-1 Drug Resistance Through Week 96, Participants With Viral Resistance|Resistance Analysis Set: participants with either suboptimal virologic response or virologic rebound were considered to have virologic failure and were analyzed. Suboptimal virologic response was assessed at Week 8 and was defined as having HIV-1 RNA ≥ 50 copies/mL and < 1-log10 reduction from baseline at the Week 8 visit, which was confirmed at the subsequent visit. Virologic rebound was defined as having 2 consecutive visits with HIV-1 RNA ≥ 400 copies/mL after achieving HIV-1 RNA < 50 copies/mL, or as having 2 consecutive visits with > 1 log10 increase in HIV-1 RNA from their nadir. In addition, subjects who were on study drugs, had not been analyzed previously, and who had HIV-1 RNA ≥ 400 copies/mL at Week 48, Week 96, or their last visit (at or after Week 8) were also analyzed for resistance at their last visit. Subsequent to the first resistance testing, subjects experiencing repeated confirmed virologic failure were assessed for resistance retesting on a case-by-case basis.|Baseline to Week 96|Resistance Analysis Set||participants|||Number
838392|NCT01309243|Secondary|Development of HIV-1 Drug Resistance Through Week 96, All Participants|Participants who experienced either suboptimal virologic response or virologic rebound were considered to have virologic failure and were analyzed for resistance. Suboptimal virologic response was assessed at Week 8 and was defined as having HIV-1 RNA ≥ 50 copies/mL and < 1-log10 reduction from baseline at the Week 8 visit, which was confirmed at the subsequent visit. Virologic rebound was defined as having 2 consecutive visits with HIV-1 RNA ≥ 400 copies/mL after achieving HIV-1 RNA < 50 copies/mL, or as having 2 consecutive visits with > 1 log10 increase in HIV-1 RNA from their nadir. In addition, subjects who were on study drugs, had not been analyzed previously, and who had HIV-1 RNA ≥ 400 copies/mL at Week 48, Week 96, or their last visit (at or after Week 8) were also analyzed for resistance at their last visit. Subsequent to the first resistance testing, subjects experiencing repeated confirmed virologic failure were assessed for resistance retesting on a case-by-case basis.|Baseline to Week 96|Full Analysis Set||percentage of participants|||Number
838393|NCT01309243|Secondary|Change From Baseline in Fasting Triglycerides at Week 48||Baseline to Week 48|Participants in the Safety Analysis Set with available data were analyzed using the missing = excluded method.||mg/dL||Standard Deviation|Mean
838394|NCT01309243|Secondary|Change From Baseline in Fasting Low-density Lipoprotein (LDL) Cholesterol at Week 48||Baseline to Week 48|Participants in the Safety Analysis Set with available data were analyzed using the missing = excluded method.||mg/dL||Standard Deviation|Mean
838395|NCT01309243|Secondary|Change From Baseline in Fasting High-density Lipoprotein (HDL) Cholesterol at Week 48||Baseline to Week 48|Participants in the Safety Analysis Set with available data were analyzed using the missing = excluded method.||mg/dL||Standard Deviation|Mean
838396|NCT01309243|Secondary|Change From Baseline in Fasting Total Cholesterol at Week 48||Baseline to Week 48|Participants in the Safety Analysis Set with available data were analyzed using the missing = excluded method.||mg/dL||Standard Deviation|Mean
838397|NCT01309243|Secondary|Change From Baseline in CD4 Cell Count at Week 96||Baseline to Week 96|Participants in the Full Analysis Set with available data were analyzed; the missing = excluded method was used in which all participants with missing data were excluded from analysis.||cells/μL||Standard Deviation|Mean
838398|NCT01309243|Secondary|Change From Baseline in CD4 Cell Count at Week 48||Baseline to Week 48|Participants in the Full Analysis Set with available data were analyzed; the missing = excluded method was used in which all participants with missing data were excluded from analysis.||cells/μL||Standard Deviation|Mean
838399|NCT01309243|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the US FDA snapshot algorithm.|Baseline to Week 96|Full Analysis Set||percentage of participants|||Number
838400|NCT01309243|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48|"The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the US FDA snapshot algorithm.
The snapshot algorithm defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time."|Week 48|Full Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug||percentage of participants|||Number
838401|NCT01309269|Primary|Average Methoxy Polyethylene Glycol-epoetin Beta Dose|Average methoxy polyethylene glycol-epoetin beta dose per application by study month. Mean values were taken when more than 1 application was documented for a participant during the time period considered.|Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24|Effectiveness Population I. N (number of participants analyzed) = participants evaluable for this measure. n = participants with methoxy polyethylene glycol-epoetin beta dose values during study period considered.||microgram (mcg)||Standard Deviation|Mean
838402|NCT01309269|Primary|Percentage of Participants Within Pre-defined Range of Hemoglobin Values|Percentage of participants with hemoglobin values within the following pre-defined ranges is presented: 11-12 gram/deciliter (g/dL), 10–12 g/dL, 11-13 g/dL, and 10-13 g/dL.|Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24|Effectiveness Population I. N (number of participants analyzed) = participants evaluable for this measure. n = participants with hemoglobin values during study period considered.||percentage of participants|||Number
838464|NCT01316315|Secondary|Measurement of Change in Methacholine PC20 From Baseline Compared With Placebo 8 Hours After Dosing|These assessments will be recorded at various times over the study - Methacholine PC20 at screening, and at 8, 24, 48 hours postdose and Day 7; spirometry assessments will be recorded at screening, at 2, 4, 6, 8, 24, 48 hours postdose and Day 7.|8 hours|Any patient that received a dose of N6022 or Placebo||mg/mL||Standard Error|Mean
838403|NCT01309269|Primary|Hemoglobin Levels at Monthly Intervals|Hemoglobin levels were measured as grams/deciliter (g/dL).|Prior to Day 1, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24|Effectiveness Population I: all participants for whom at least 1 hemoglobin value was documented after the first application of methoxy polyethylene glycol-epoetin beta during the study course. N (number of participants analyzed) = participants evaluable for this measure. n = participants with hemoglobin values during study period considered.||g/dL||Standard Deviation|Mean
838404|NCT01309282|Secondary|Number of Participants Who Experienced Any Adverse Events or Serious Adverse Events|An Adverse Events (AE) is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A Serious Adverse Events (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect|Up to Month 24|Safety population was used for the analysis which included all participants who received at least one dose of study drug, whether prematurely withdrawn from the study or not and who complied with the criteria for inclusion.||Participants|||Number
838405|NCT01309282|Secondary|Number of Participants With Incidence of Infectious Events|Follow-up of the infectious events was done after Month 6 visit, Month 12 visit and Month 24 visit.|At Months 6, 12 and 24|Safety population was used for the analysis which included all participants who received at least one dose of study drug, whether prematurely withdrawn from the study or not and who complied with the criteria for inclusion.||Participants|||Number
838406|NCT01309282|Secondary|Number of Participants With Incidence of Infusion Reactions or Injection Site Reactions|An infusion reaction or injection site reaction is an event that occurs after infusion or injection which may include hypersensitivity reactions or anaphylactic reactions.|At Months 6, 12 and 24|Safety population was used for the analysis which included all participants who received at least one dose of study drug, whether prematurely withdrawn from the study or not and who complied with the criteria for inclusion.||Participants|||Number
838407|NCT01309282|Secondary|Number of Participants on Each Pattern of Re-treatment|"There are two patterns of re-treatment, namely treat-to-target and according to the clinic.
Treat-to-target: a new cycle every 6 months if not in remission, with the participant receiving no new course of treatment as long as he is in remission.
On demand (according to clinic): a new cycle when, in an assessment performed at least 16 weeks after the last treatment cycle, the participant shows moderate or high disease activity [DAS28 > 3.2 or difference in DAS28 (ΔDAS28) > 0.6]"|Up to Month 24|The analysis was conducted with all 9 participants who complied with the inclusion and exclusion criteria, thus defining the full analysis set.||Participants|||Number
838408|NCT01309282|Secondary|Reason for Change From First TNF-inhibitor Therapy to Rituximab|Adverse event, primary and secondary insufficient responses and monoclonal gammopathy were the reasons for starting rituximab therapy.|At Screening|The analysis was conducted with all 9 participants who complied with the inclusion and exclusion criteria, thus defining the full analysis set.||Participants|||Number
838409|NCT01309282|Secondary|Mean Change Form Baseline in Functional Capacity at Month 24|The functional capacity was analyzed using Health Assessment Questionnaire-Disability Index (HAQ-DI). It is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 domains (dressing, arising, eating, walking, hygiene, reaching, gripping and activities of daily living). Responses in each domain are scored from 0 to 3 (0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do). Overall score was computed as sum of domain scores and divided by the number of domains. A total possible score ranged from 0 (best) to 3 (worst).|Baseline (Day 0) and Month 24|The analysis was conducted with all the participants who complied with the inclusion and exclusion criteria, thus defining full analysis set (n=9). However, the results are presented only for the participants with available data and who completed Month 24 visit (n=7).||Scores on a scale||Standard Deviation|Mean
838410|NCT01309282|Secondary|Mean Change From Baseline in Severity of Pain at Month 24|The patient's assessment of pain was performed using a 100 mm VAS ranging from no pain (0) to unbearable pain (100). The distance in mm from the left edge of the scale was measured. A negative change from Baseline score indicates improvement in pain intensity.|Baseline (Day 0) and Month 24|The analysis was conducted with all the participants who complied with the inclusion and exclusion criteria, thus defining full analysis set (n=9). However, data is presented only for those participants who completed Month 24 visit (n=8).||Scores on a scale||Standard Deviation|Mean
838411|NCT01309282|Secondary|Mean Change From Baseline in Patient's Global Assessment of Disease Activity at Month 24|The Patient’s Global Assessment of disease activity was assessed using VAS. The left-hand extreme of the line equals 0 mm, and is described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as “maximum disease activity” (maximum arthritis disease activity).Change from Baseline = score at observation minus score at Baseline. An increase in score from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.|Baseline (Day 0) and Month 24|The analysis was conducted with all the participants who complied with the inclusion and exclusion criteria, thus defining full analysis set (n=9). However, data is presented only for those participants who completed Month 24 visit (n=8).||Scores on a scale||Standard Deviation|Mean
838412|NCT01309282|Secondary|Mean Change From Baseline in Physician's Global Assessment of Disease Activity At Month 24|The Physician’s Global Assessment of disease activity was assessed using a Visual Analogue Scale (VAS). The left-hand extreme of the line equals 0 mm, and is described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as “maximum disease activity” (maximum arthritis disease activity).Change from Baseline = score at observation minus score at Baseline. An increase in score from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.|Baseline (Day 0) and Month 24|The analysis was conducted with all the participants who complied with the inclusion and exclusion criteria, thus defining full analysis set (n=9). However, data is presented only for those participants who completed Month 24 visit (n=8).||Scores on a scale||Standard Deviation|Mean
838413|NCT01309282|Secondary|Mean Change From Baseline in C-reactive Protein at Month 24|The C-reactive protein is an inflammation marker. High levels of this protein indicate inflammation in diseases such as RA. A negative change from baseline indicates improvement.|Baseline (Day 0) and Month 24|The analysis was conducted with all the participants who complied with the inclusion and exclusion criteria, thus defining full analysis set (n=9). However, data is presented only for those participants who completed Month 24 visit (n=8).||Milligrams/liter||Standard Deviation|Mean
838414|NCT01309282|Secondary|Mean Change From Baseline in ESR at Month 24|The ESR is an acute phase reactant and a measure of inflammation. A negative change from baseline indicates improvement.|Baseline (Day 0) and Month 24|The analysis was conducted with all the participants who complied with the inclusion and exclusion criteria, thus defining full analysis set (n=9). However, data is presented only for those participants who completed Month 24 visit (n=8).||Millimeter (mm)/hour||Standard Deviation|Mean
838415|NCT01309282|Secondary|Mean Change From Baseline in SJC at Month 24|A swollen joint count (SJC) is the most specific clinical method to quantify abnormalities in participants with RA. It reflects the amount of inflamed synovial tissue. Twenty-eight joints were assessed for swelling. Joints were classified as swollen (1)/ not swollen (0) giving a total possible SJC score of 0 to 28. A negative change from baseline indicates improvement.|Baseline (Day 0) and Month 24|The analysis was conducted with all the participants who complied with the inclusion and exclusion criteria, thus defining full analysis set (n=9). However, data is presented only for those participants who completed Month 24 visit (n=8).||Swollen joints||Standard Deviation|Mean
838416|NCT01309282|Secondary|Mean Change From Baseline in TJC at Month 24|A tender joint count (TJC) is the most specific clinical method to quantify abnormalities in participants with RA. It is associated with the level of pain. Twenty-eight joints were assessed for tenderness. Joints were classified as tender (1)/not tender (0) giving a total possible TJC score of 0 to 28. A negative change from baseline indicates improvement.|Baseline (Day 0) and Month 24|The analysis was conducted with all the participants who complied with the inclusion and exclusion criteria, thus defining full analysis set (n=9). However, data is presented only for those participants who completed Month 24 visit (n=8).||Tender joints||Standard Deviation|Mean
838417|NCT01309282|Primary|Mean Change From Baseline in Disease-activity Score 28-Erythrocyte Sedimentation Rate at Month 24|The disease-activity score 28 (DAS28) score is a measure of validated instrument for the assessment of the overall severity of RA disease activity calculated using the tender joint count (TJC), swollen joint count (SJC), patient's global assessment of disease activity, and erythrocyte sedimentation rate (ESR) for a total possible score of 2 to 10. Higher values indicate higher disease activity. A negative change from baseline indicates improvement.|Baseline (Day 0) and Month 24|The analysis was conducted with all the participants who complied with the inclusion and exclusion criteria, thus defining full analysis set (n=9). However, data is presented only for those participants who completed Month 24 visit (n=8).||Scores on a scale||Standard Deviation|Mean
838418|NCT01309308|Secondary|The Duration of Latency Until Labor|The period (in days) from the last cervical measurement to the start of second phase of labor.|15 days|||days||Standard Deviation|Mean
838419|NCT01309308|Primary|Cervical Shortening|Cervix 1 was measured at the sagittal plane of cervix from external to the internal os. Two days later cervix 2 was measured the same way. The cervical shortening was calculated from subtracting cervix 1 from cervix 2.|2days|analysis was per person who delivered||millimeters||Standard Deviation|Mean
838420|NCT01309360|Secondary|Number of Participants With Subjective Adverse Events as a Measure of Safety and Tolerability.|In groups A, B and C was determined the rate of subjective clinical signs of increased Met-Hb-Levels : headaches or dizziness, when correlated with the peak-Met-Hb-Level.|Outpatients were followed for the duration of hospital stay, an average of six hours.|||participants|||Number
838421|NCT01309360|Primary|Onset Time.|Time from beginning of administration of the local anesthetic until complete sensoric block.|within 60 minutes after administration of the local anesthetic|In some cases the investigators were not able to exactly determine an onset time, so in cases of block failure (supplementation needed) or emergency situations outside this study (onset time not examined). Therefore the number of participants analyzed concerning onset time is lower then the total number of outpatients in each group.||minutes||Standard Deviation|Mean
838422|NCT01309360|Primary|Number of Participants With Complete Motor Blocks|To examine the extent of the motor block the manual muscle function test after Vladimir Janda was used. As a complete motor block was defined, when no motion (grade zero after Janda) of muscles innervated by the four blocked nerves (musculocutaneous, median, radial and ulnar nerve) was observed within 60 minutes after administration of the local anesthetic.|Within 60 minutes after administration of the local anesthetic|The analysis was per protocol.||participants|||Number
838423|NCT01309360|Secondary|Number of Participants With Objective Adverse Events as a Measure of Safety and Tolerability|In groups A, B and C was determined the rate of objective clinical signs of increased Met-Hb-levels : drops in oxygen saturation <93% using pulseoximetry or lip cyanosis.|Outpatients were followed for the duration of hospital stay, an average of six hours.|||participants|||Number
838424|NCT01309360|Secondary|Maximum Concentrations of Methemoglobin|Concentration of Methemoglobin (Met-Hb) was measured using spectrophotometry prior to the anesthesia (baseline value) and then hourly after performing the block until a clear decrease became apparent. The maximum amount was reached in every case two or three hours after administration of the local anesthetic.|0,1,2,3,4 hours post-dose|Methemoglobin (Met-Hb) levels were measured using spectrophotometry prior to the anesthesia (baseline value) and then hourly after performing the block until a clear decrease became apparent.The mean maximum Met-Hb was estimated in each group.||percentage of methemoglobin||Standard Deviation|Mean
838425|NCT01309360|Primary|Number of Participants With Complete Sensory Block|The number of outpatients with complete sensory block of all 4 nerves (n.musculocutaneous, n.radialis, n.ulnaris,n.medianus) was registrated in each group.|60 minutes after administration of the local anesthetic|The analysis was per protocol.||participants|||Number
838465|NCT01316315|Primary|Measurement of Change in Methacholine PC20 From Baseline Compared With Placebo 24 Hours After Dosing|These assessments will be recorded at various times over the study - Methacholine PC20 at screening, and at 8, 24, 48 hours postdose and Day 7; spirometry assessments will be recorded at screening, at 2, 4, 6, 8, 24, 48 hours postdose and Day 7.|24 hours|Any patient that received a dose of N6022 or placebo.||mg/mL||Standard Error|Mean
838426|NCT01309386|Secondary|Average Change From Baseline in Amount of Rescue Medication Over Time|Rescue medications are medicines that are administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation. Supplemental analgesics (drug used to control pain) were used as rescue medication. Average amount was the averages of all doses recorded during the baseline period or during each week (Week 1, 2, 3, 4, 5, 6, 7 and 8).|Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8|Full analysis set (FAS) population included all participants who were randomly assigned, received at least 1 dose of study drug and had post-baseline efficacy data.||Milligram (mg)||Standard Deviation|Mean
838427|NCT01309386|Secondary|Number of Doses of Rescue Medication Over Time|Number of doses of rescue medication over time were assessed. Rescue medications are medicines that are administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation. Supplemental analgesics (drug used to control pain) were used as rescue medication.|Baseline up to Week 8|Full analysis set (FAS) population included all participants who were randomly assigned, received at least 1 dose of study drug and had post-baseline efficacy data.||Morphine-equivalent doses||Standard Deviation|Mean
838428|NCT01309386|Secondary|Total Number of Days of Rescue Medication Over Time|Total number of days of rescue medication over time were assessed. Rescue medications are medicines that are administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation. Supplemental analgesics (drug used to control pain) were used as rescue medication.|Baseline up to Week 8|Full analysis set (FAS) population included all participants who were randomly assigned, received at least 1 dose of study drug and had post-baseline efficacy data.||Days||Standard Deviation|Mean
838429|NCT01309386|Secondary|Number of Participants With Patient Global Impression of Change (PGIC)|"The PGIC is a single-item questionnaire designed to provide an overall assessment of treatment from the participant's perspective since the start of the study. It is measured on a 7-point scale, where 1=very much improved and 7=very much worse. A participant is considered a responder if they have a response of very much improved or much improved."|Week 1, 4 and 8|Full analysis set (FAS) population; here ‘N’ signifies those participants evaluable for this outcome measure and ‘n’ signifies those participants evaluable for this measure at the specified time point for each arm group, respectively.||Participants|||Number
838430|NCT01309386|Secondary|Number of Participants Who Discontinued Study Treatment Due to Lack of Efficacy|Number of participants who discontinued the treatment due to lack of efficacy were assessed throughout the study.|Baseline up to Week 8|Full analysis set (FAS) population included all participants who were randomly assigned, received at least 1 dose of study drug and had post-baseline efficacy data.||Participants|||Number
838431|NCT01309386|Secondary|Change From Baseline in Numerical Rating Scale (NRS) at Week 1, 2, 3, 4, 5, 6, 7 and 8|Average pain intensity was assessed using an 11-point NRS to measure the pain level for the past 24-hours where 0=no pain to 10=pain as bad as you can imagine.|Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8|Full analysis set (FAS) population included all participants who were randomly assigned, received at least 1 dose of study drug and had post-baseline efficacy data. Here ‘n’ signifies those participants evaluable for this measure at the specified time point for each arm group, respectively.||Unit on scale||Standard Deviation|Mean
838432|NCT01309386|Primary|Percentage of Participants Who Achieved Pain Control|Pain control was considered to be achieved for participants who met both of the following criteria for any consecutive 3 days during the first week of treatment period: a) Change from baseline of mean 24 hour numerical rating scale (NRS) (an 11-point NRS is used to measure the pain level where 0=no pain to 10=pain as bad as you can imagine) score less than +1.5, and b) when the frequency of rescue medication was twice or less per day.|Week 1|Full analysis set (FAS) population included all participants who were randomly assigned, received at least 1 dose of study drug and had post-baseline efficacy data.||Percentage of Participants||95% Confidence Interval|Number
838433|NCT01309451|Primary|OCT CST|change in optical coherence tomography central subfield thickness|change in OCT CST from baseline to twelve months|||microns||Standard Deviation|Mean
838434|NCT01309451|Primary|Change in Best Corrected Visual Acuity (BCVA) Measured Using Early Treatment of Diabetic Retinopathy Study (ETDRS) Methodology at Month 12 Compared to Baseline|Visual Acuity was measured with the Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity test. Unit of measure is based on the ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.|baseline to 12 month|The unit of measure is EYES rather than actual number of participants||letters||Standard Deviation|Mean
838435|NCT01316224|Secondary|Change in the Subject Proportion That Achieved a PASI (Psoriasis Area and Severity Index) Reduction of ≥50%|This outcome measure was not calculated.|At Baseline, Week 24, and Week 48||||||
838436|NCT01316224|Secondary|Incidence Rate of PsA Since Psoriasis Diagnosis|"The number of new PsA cases were determined by:
PsA defined by a rheumatologist; or
A participant with inflamed joints >0 and CASPAR score >=3; or
Participant meeting at least one of the two previous definitions occurring over person time (defined as the overall sum of Psoriasis disease duration without PsA)."|Baseline up to Visit 4 (month 12)|ITT population||new PsA cases per 100 person years||95% Confidence Interval|Number
838437|NCT01316224|Primary|Percentage of Participants Who Developed Signs or Symptoms of PsA|Signs or symptoms were defined as mentioning at the rheumatologist visit any joint symptoms prior to or during the visit or a total number of inflamed joints greater than 0.|At Baseline, Visit 3 (month 6) and Visit 4 (month 12)|Participants who completed the visits (visit 3 and visit 4) to the rheumatologist and for whom information was available.||Percentage of participants|||Number
838438|NCT01316224|Primary|Percentage of Participants Who Developed Psoriatic Arthritis (PsA)|"A participant is said to have PsA if they meet the following criteria:
PsA defined by a rheumatologist; or
A participant with inflamed joints >0 and CASPAR score >=3; or
Participant meeting at least one of the two previous definitions."|At Baseline, Visit 3 (month 6) and Visit 4 (month 12)|Participants who completed the visits (visit 3 and visit 4) to the rheumatologist and for whom information was available.||Percentage of participants|||Number
839186|NCT01324622|Primary|Improvement in Modified Japanese Orthopaedic Assessment (mJOA) Recovery Rate|"Participants who have mJOA Recovery Rate ≥0%. mJOA Recovery Rate is defined as:
mJOA Recovery Rate = ((PostOp Score-PreOp Score)/(17 - Pre-Op Score))*100"|12 months|Number of subject with 12-month follow-up data.||participants|||Number
838440|NCT01316224|Secondary|Percentage of Participants With Swollen Joint Count (SJC) and Tender Joint Count (TJC) Greater Than Zero|"Pressure and joint manipulation by physical examination on 68 or 66 joints or regions (34 or 32 per body side, hip joints excluded) were assessed for TJC or SJC, respectively. Both joint tenderness and swelling were classified as present (1), absent (0), replaced (9), or no assessment (NA). The total TJC or SJC was derived as the sum of the tender and swollen joints; the range for TJC and SJC was 0 - 68 and 0 - 66, respectively; with higher scores indicating worse conditions."|At Baseline, Visit 3 (month 6) and Visit 4 (month 12)|Participants who completed the visits (visit 3 and visit 4) to the rheumatologist and for whom information was available.||Percentage of participants|||Number
838441|NCT01316224|Secondary|Percentage of Participants With a CASPAR Score Greater Than or Equal to 3 at Each Visit to the Rheumatologist|The CASPAR criteria permits the diagnosis of PsA in spite of low rheumatoid factor positivity. To be classified as having PsA, a participant must have inflammatory articular disease (joint, spine, entheseal) with greater than or equal to 3 of the following 5 points: evidence of psoriasis (current, history of, or family history of); psoriatic nail dystrophy; a negative RF test result; dactylitis (history of or current); and radiographic evidence of juxa-articular new bone formation. Only current psoriasis (2 points) was weighted more heavily than the other features (1 point).|At Baseline, Visit 3 (month 6) and Visit 4 (month 12)|Participants who completed the visits (visit 3 and visit 4) to the rheumatologist and for whom information was available.||Percentage of participants|||Number
838442|NCT01316224|Secondary|Mean Change in ClASsification Criteria for Psoriatic ARthritis (CASPAR) Score|The CASPAR criteria permits the diagnosis of PsA in spite of low rheumatoid factor positivity. To be classified as having PsA, a participant must have inflammatory articular disease (joint, spine, entheseal) with greater than or equal to 3 of the following 5 points: evidence of psoriasis (current, history of, or family history of); psoriatic nail dystrophy; a negative RF test result; dactylitis (history of or current); and radiographic evidence of juxa-articular new bone formation. Only current psoriasis (2 points) was weighted more heavily than the other features (1 point). CASPER scores range from 1 to 6, with 6 indicating a more definitive diagnosis of PsA.|At Baseline, Visit 3 (month 6) and Visit 4 (month 12)|Participants who completed the visits (visit 3 and visit 4) to the rheumatologist and for whom information was available.||CASPAR score||Standard Deviation|Mean
838443|NCT01316224|Secondary|Mean Change in Quality of Life (QoL)|The Short Form-36 was a self-reported questionnaire used to measure the QoL of participants in eight main health dimensions (physical functioning; bodily pain; role limitations due to physical health, personal, and emotional problems; emotional well-being; social functioning; vitality; and general health perception). The score from each health dimension was added together for a QoL score on a scale of 0 - 100; a higher score indicated a better QoL.|At Baseline, Visit 3 (month 6) and Visit 4 (month 12)|ITT population||Score on scale||Standard Deviation|Mean
838444|NCT01316224|Secondary|Percentage of Participants With Comorbidities Who Did or Did Not Develop PsA|Percentage of participants with comorbidities (metabolic syndrome, hypertension, diabetes, atherosclerosis, obesity, alcohol and other associated comorbidities) was assessed.|Baseline up to Visit 4 (month 12)|Participants who completed at least one of the follow up visits to the rheumatologist.||Percentage of participants|||Number
838445|NCT01316224|Secondary|Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score|The PASI score was used to measure the severity of psoriasis. It combined the assessment of the severity of lesions and the area affected into a single score ranging from 0 (no disease) to 72 (maximal disease).|At Baseline, Visit 2 (month 2), Visit 3 (month 6) and Visit 4 (month 12)|ITT population||PASI score||Standard Deviation|Mean
838446|NCT01316224|Secondary|Mean Time to First Occurrence of PsA Signs or Symptoms|The measure of time from Psoriasis diagnosis to the appearance of PsA signs or symptoms.|Baseline up to Visit 4 (month 12)|Participants who completed at least one of the follow up visits to the rheumatologist.||Years||95% Confidence Interval|Mean
838447|NCT01316263|Secondary|Percentage of Participants With Human Anti-Olaratumab (IMC-3G3) Antibody Results|Participants with Treatment Emergent (TE) anti-olaratumab (IMC-3G3) antibodies were participants with a 4-fold increase (2 dilutions) increase over a positive baseline antibody titer or for a negative baseline titer, a participant with an increase from the baseline to a level of 1:20.|Day 1 of Cycles 1, 3, 6, 12 and 18 prior to infusion (14-day cycles)|All participants who received at least one dose of study drug and had evaluable baseline and evaluable post-baseline antibody data.||percentage of participants|||Number
838448|NCT01316263|Secondary|Volume of Distribution at Steady State (Vss)||Day 1 of Cycles 1 and 3 (14-day cycles)|Zero participants were analyzed. Vss was not reported. Vss could not be calculated due to an insufficient number of olaratumab serum concentrations.|||||
838449|NCT01316263|Secondary|Clearance (CL)||Day 1 of Cycles 1 and 3 (14-day cycles)|Zero participants were analyzed. CL was not reported. CL could not be calculated due to an insufficient number of olaratumab serum concentrations.|||||
838450|NCT01316263|Secondary|Half Life (t½)||Day 1 of Cycles 1 and 3 (14-day cycles)|Zero participants were analyzed. t1/2 was not reported. t1/2 could not be calculated due to an insufficient number of olaratumab serum concentrations.|||||
838451|NCT01316263|Secondary|Area Under the Curve (AUC)||Day 1 of Cycles 1 and 3 (14-day cycles)|Zero participants were analyzed. AUC was not reported. AUC could not be calculated due to an insufficient number of olaratumab serum concentrations.|||||
838452|NCT01316263|Secondary|Maximum Concentration (Cmax)||Day 1 of Cycles 1 and 3 (14-day cycles)|All participants who had evaluable pharmacokinetic (PK) Cmax results at the specific time point. Due to the limited data, Cmax is not representative of the study population.||nanograms per milliliter (ng/mL)||Full Range|Mean
838466|NCT01316341|Primary|Fasting Plasma Glucose (FPG) Change From Baseline|Fasting Plasma Glucose (FPG) change from baseline between day 1 and day 9.|Sampling intervals were 0-2 hours (h), 2-4h, 4-8h, 8-12h and 12-24h after drug administration|Pharmacodynamic analysis (PD) set included all patients documented to have taken at least one dose of investigational treatment, who received at least one dose of empagliflozin or placebo and who provided at least one baseline and post-treatment observation for at least one PD endpoint.||mg/dL||Standard Deviation|Mean
838594|NCT01319383|Secondary|Number of Participants With Confirmed Non-hematologic Toxicity >/= Grade 3 and Related to VOR Per Division of AIDS (DAIDS) Grading Table|DAIDS Grading Table- Grade 1- mild, Grade 2- moderate; Grade 3- severe Grade 4- potentially life-threatening. Pre specified to combine all participants into one arm.|24 hrs following single dose and 1 week after last of multiple dose sequence|All participants receiving one or more doses of VOR 400 mg PO in any and all Arms of the study.||Participants|||Count of Participants
838453|NCT01316263|Secondary|Percentage of Participants With CR, PR or SD [Disease Control Rate (DCR)]|DCR defined as CR, PR or SD using RECIST v1.1 criteria. CR was defined as the disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 mm. PR was defined as ≥30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify PD, taking as reference the smallest sum diameter since the treatment started. PD defined as ≥20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). Sum must also have demonstrated an absolute increase of ≥5 mm, or the appearance of 1 or more new lesions was considered progression. Percentage of participants=(number of participants with CR+PR+SD/number of participants in group) * 100.|Baseline up to 35.9 weeks|All participants who received any study drug.||percentage of participants||90% Confidence Interval|Number
838454|NCT01316263|Secondary|Number of Participants With Adverse Events (AE) and Participants Who Died|Clinically significant events were defined as serious AEs (SAEs) and other non-serious AEs, regardless of causality. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module. The number of participants who died due to an AE or disease progression are also reported.|Baseline up to 57.3 weeks and 30-day post study-discontinuation follow-up|All participants who received any study drug.||participants|||Number
838455|NCT01316263|Secondary|Overall Survival (OS)|OS was defined as the time from the date of first dose of study drug to the date of death from any cause. Participants who were alive at the end of the post-study follow-up or were lost to follow-up were censored on the last date the participant was known to be alive.|Date of first dose of study drug to the date of death from any cause up to 57.3 weeks|All participants who received any study drug. Participants censored: PDGFRα Mutant=4, PDGFRα Wild-type=4.||weeks||90% Confidence Interval|Median
838456|NCT01316263|Secondary|Percentage of Participants With CR or PR [Radiographic Objective Response Rate (ORR)]|The ORR was the best overall response of CR and PR using RECIST, v1.1 criteria. Participants who did not have a tumor response assessment for any reason were considered nonresponders and were included in the denominator that calculated the response rate. Percentage of participants = (number of participants achieving a response/total of participants treated) * 100.|Baseline up to 35.9 weeks and post study discontinuation 30-day follow-up|All participants who received any study drug.||percentage of participants||90% Confidence Interval|Number
838457|NCT01316263|Secondary|Progression-Free Survival (PFS)|PFS defined as the duration from date of first dose of study drug until first radiographic documentation of PD using RECIST, v1.1 criteria or death from any cause. PD defined as ≥20% increase in the sum of diameters of target lesions, taking as reference smallest sum on study (included baseline sum if that was the smallest on study); sum must have demonstrated an absolute increase of ≥5 mm and the appearance of ≥1 new lesions was progression. Participants who died with no prior PD were considered to have progressed on day of death. Participants who did not progress or were lost to follow-up were censored at date of last radiographic tumor assessment; if no assessment was available censoring was at date of registration. If death or PD occurred after 2 consecutive missing radiographic visits censoring was date of last radiographic visit prior to missed visits. Use of new anticancer therapy prior to PD, censoring was date of last radiographic assessment prior to new therapy.|Baseline to the first date of objectively determined PD or death from any cause up to 35.9 weeks|All participants who received any study drug. Censored participants: PDGFRα Mutant=2, PDGFRα Wild-Type=0.||weeks||90% Confidence Interval|Median
838458|NCT01316263|Primary|Percentage of Participants With Tumor Response of Stable Disease (SD), Partial Response (PR) or Complete Response (CR) (Clinical Benefit Rate) at 12 Weeks|Clinical benefit was defined as CR, PR, or SD using Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST, v1.1) criteria. CR: disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 millimeters (mm). PR: ≥30% decrease in sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter. SD: neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started. PD: increase ≥20% in sum of the diameters of target lesions, taking as reference the smallest sum on study (included baseline sum if that was the smallest on study). Sum must also have demonstrated an absolute increase of ≥5 mm, or appearance of 1 or more new lesions was considered progression. Percentage of participants=(participants with CR+PR+SD/participants in group) *100.|12 weeks|All participants who received any study drug.||percentage of participants||90% Confidence Interval|Number
838459|NCT01316302|Secondary|Patient Global Impression of Change|Subject-rated global outcome scale. Subjects who rated themselves as 1 (Very Much Improved) or 2 (Much Improved) on the PGIC were considered self-rated responders.|Baseline to study endpoint (Week 12)|||percentage of self-rated responders|||Number
838460|NCT01316302|Secondary|Clinical Global Impression of Improvement Scale (CGI-I)|CGI-I: one item, measuring overall improvement of illness; possible scores range from 1-7, with lower scores representing greater improvement. CGI-I responders: defined as having a CGI-I scores of 1 or 2 at Week 12/study endpoint.|Baseline to Week 12|||% of subjects who were CGI-I responders|||Number
838461|NCT01316302|Primary|Change in the Liebowitz Social Anxiety Scale (LSAS) Total Score|Liebowitz Social Anxiety Scale, measuring social anxiety symptoms; possible total scores ranging from 0-144, with higher scores indicating greater severity of symptoms.|Baseline to study endpoint (Week 12)|The number of participants for analysis was 29 subjects per arm; data analyzed at Week 12 or Last Observation Carried Forward for the 16 subjects who dropped out before completion. Five other randomized subjects (1 on drug, 4 on placebo) were excluded from the ITT sample because of insufficient data (n = 4) or poor compliance (n = 1).||Scores on a scale||Standard Deviation|Mean
838462|NCT01316315|Other Pre-specified|Measurement of Change in Methacholine PC20 From Baseline Compared With Placebo After 7 Days of Dosing||7 Days|Any patient that received a dose of N6022 or Placebo||mg/mL||Standard Error|Mean
838463|NCT01316315|Secondary|To Assess the Safety and Tolerability of Single Dose Administration of N6022 in Patients With Mild Asthma.|Adverse event (AE) reporting will begin upon signing of the consent and will continue until end-of-study (follow up phone call Day 28 +/- 2 days after dosing in the second treatment period). Number of patients with an adverse event will be documented and analyzed.|10 Weeks|Any patient that received a dose of N6022 or placebo||Adverse Events|||Number
838467|NCT01316341|Primary|Urinary Glucose Excretion (UGE) Change From Baseline|Change from day -1 in urinary glucose excretion in a 24 hour collection period per time point.|Sampling intervals were 0-2 hours (h), 2-4h, 4-8h, 8-12h and 12-24h after drug administration|Pharmacodynamic analysis (PD) set included all patients documented to have taken at least one dose of investigational treatment, who received at least one dose of empagliflozin or placebo and who provided at least one baseline and post-treatment observation for at least one PD endpoint.||mg||Standard Deviation|Mean
838468|NCT01316341|Secondary|Clinical Relevant Abnormalities for Protocol-Specified Significant Adverse Events, Hypoglycaemic Events, Vital Signs, Blood Chemistry, Rescue Therapy, Body Weight and Waist Circumference|"Clinically relevant abnormalities for protocol-specified significant adverse events, hypoglycaemic events, vital signs, blood chemistry, use of rescue therapy, change in body weight and change in waist circumference.
Results shown are for hypoglycaemic events, as this was the only event that occurred for this endpoint."|Drug administration until end of trial, up to 21 days|Treated set (TS) includes all patients who were documented to have taken at least one dose of investigational treatment.||participants|||Number
838469|NCT01316341|Primary|Predose Plasma Concentration Before Planned Dose x (Cpre,x)|"Predose plasma concentration of empagliflozin (empa) before planned dose by day.
This endpoint in steady state is identical to Cmin,ss."|5 minutes before drug administration|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
838470|NCT01316341|Primary|Accumulation Ratio Based on Cmax (R A,Cmax)|Accumulation ratio of empagliflozin (empa) based on Cmax, after multiple dosing|5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, and16h after drug administration between days 5 and 9|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.||Ratio||Geometric Coefficient of Variation|Geometric Mean
838471|NCT01316341|Primary|Accumulation Ratio Based on AUC (R A,AUC)|Accumulation ratio of empagliflozin (empa) based on AUC, after multiple dosing|5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, and16h after drug administration on days 1 and 9|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.||Ratio||Geometric Coefficient of Variation|Geometric Mean
838472|NCT01316341|Primary|Renal Clearance at Steady State (CL R,ss)|Renal clearance of empagliflozin (empa) in plasma after extravascular administration, after multiple dosing.|5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h 48h, 60h, 72h and 96h after drug administration on day 9|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.||mL/min||Geometric Coefficient of Variation|Geometric Mean
838473|NCT01316341|Primary|Fraction of Empagliflozin Excreted Unchanged in Urine at Steady State in the Time Interval 0 Hours to 24 Hours (fe 0-24,ss)|Fraction of empagliflozin (empa) excreted unchanged in urine at steady state in the time interval 0 hours to 24 hours, after multiple dosing.|Sampling intervals were 0-2 hours (h), 2-4h, 4-8h, 8-12h and 12-24h after drug administration|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.||percentage of empa||Geometric Coefficient of Variation|Geometric Mean
838474|NCT01316341|Primary|Amount of Analyte Eliminated in Urine at Steady State in Time Interval 0 Hours to 24 Hours (Ae 0-24,ss)|Amount of empagliflozin (empa) eliminated in urine at steady state in the time interval 0 hours to 24 hours, after multiple dosing.|Sampling intervals were 0-2 hours (h), 2-4h, 4-8h, 8-12h and 12-24h after drug administration|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.||nmol||Geometric Coefficient of Variation|Geometric Mean
838475|NCT01316341|Primary|Apparent Volume of Distribution During the Terminal Phase λz (Vz/Fss)|Apparent volume of distribution during the terminal phase λz at steady state following oral administration after multiple dosing|5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h 48h, 60h, 72h and 96h after drug administration on day 9|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.||L||Geometric Coefficient of Variation|Geometric Mean
838476|NCT01316341|Primary|Apparent Clearance of Empagliflozin After Extravascular Administration (CL/Fss)|Apparent clearance of empagliflozin (empa) in the plasma at steady state following multiple oral dose administration.|5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h 48h, 60h, 72h and 96h after drug administration on day 9|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.||mL/min||Geometric Coefficient of Variation|Geometric Mean
838477|NCT01316341|Primary|Mean Residence Time at Steady State (MRTpo,ss)|Mean residence time of empagliflozin (empa) in the body at steady state after multiple oral administrations|5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h 48h, 60h, 72h and 96h after drug administration on day 9|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.||hours||Geometric Coefficient of Variation|Geometric Mean
838478|NCT01316341|Primary|Terminal Half-life in Plasma at Steady State (t1/2,ss)|Terminal half-life of empagliflozin (empa) in plasma at steady state, after multiple dosing.|5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h 48h, 60h, 72h and 96h after drug administration on day 9|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.||hours||Geometric Coefficient of Variation|Geometric Mean
838479|NCT01316341|Primary|Terminal Rate Constant in Plasma at Steady State (λz,ss)|Terminal rate constant in plasma at steady state, after multiple dosing.|5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h 48h, 60h, 72h and 96h after drug administration on day 9|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.||1/h||Geometric Coefficient of Variation|Geometric Mean
838480|NCT01316341|Primary|Area Under the Concentration-time Curve in Plasma at Steady State Over a Uniform Dosing Interval (AUCτ,ss)|Area under the concentration-time curve of empagliflozin (empa) in plasma at steady state over a uniform dosing interval, after multiple dosing|5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h 48h, 60h, 72h and 96h after drug administration on day 9|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
838481|NCT01316341|Primary|Time From Last Dosing to Maximum Measured Concentration Over a Uniform Dosing Interval at Steady State (Tmax,ss)|Time from last dosing to maximum measured concentration of empagliflozin (empa) in plasma over a uniform dosing interval at steady state, after multiple dosing.|5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h 48h, 60h, 72h and 96h after drug administration on day 9|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.||hours||Geometric Coefficient of Variation|Geometric Mean
838482|NCT01316341|Primary|Maximum Measured Concentration Over a Uniform Dosing Interval (Cmax,ss)|Maximum measured concentration of empagliflozin (empa) in plasma at steady state over a uniform dosing interval.|5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h 48h, 60h, 72h and 96h after drug administration on day 9|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
838483|NCT01316341|Primary|Renal Clearance After Extravascular Administration (CL R,0-48)|Renal clearance of empagliflozin (empa) in plasma after extravascular administration, after the first dose on day 1.|5 minutes (min) before drug administration and 10 min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h after drug administration|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.||mL/min||Geometric Coefficient of Variation|Geometric Mean
838484|NCT01316341|Primary|Fraction of Empagliflozin Excreted Unchanged in Urine in the Time Interval 0 Hours to 24 Hours (fe 0-24).|Fraction of empagliflozin (empa) excreted unchanged in urine in the time interval 0 hours to 24 hours, after the first dose on day 1.|Sampling intervals were 0-2 hours (h), 2-4h, 4-8h, 8-12h and 12-24h after drug administration|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.||percentage of empa||Geometric Coefficient of Variation|Geometric Mean
838485|NCT01316341|Primary|Amount of Empagliflozin Eliminated in Urine in the Time Interval 0 Hours to 24 Hours (Ae 0-24)|Amount of empagliflozin (empa) eliminated in urine in the time interval 0 hours to 24 hours, after the first dose on day 1.|Sampling intervals were 0-2 hours (h), 2-4h, 4-8h, 8-12h and 12-24h after drug administration|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.||nmol||Geometric Coefficient of Variation|Geometric Mean
838486|NCT01316341|Primary|Apparent Volume of Distribution During the Terminal Phase λz (Vz/F)|Apparent volume of distribution during the terminal phase λz, after the first dose on day 1.|5 minutes (min) before drug administration and 10 min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h after drug administration|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.||L||Geometric Coefficient of Variation|Geometric Mean
838487|NCT01316341|Primary|Apparent Clearance of Empagliflozin After Extravascular Administration (CL/F)|Apparent clearance of empagliflozin (empa) in plasma after extravascular administration, after the first dose on day 1.|5 minutes (min) before drug administration and 10 min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h after drug administration|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.||mL/min||Geometric Coefficient of Variation|Geometric Mean
838488|NCT01316341|Primary|Mean Residence Time (MRTpo)|Mean residence time of empagliflozin (empa) in the body after the first dose on day 1.|5 minutes (min) before drug administration and 10 min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h after drug administration|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.||hours||Geometric Coefficient of Variation|Geometric Mean
838489|NCT01316341|Primary|Terminal Half-life (t1/2)|Terminal half-life of empagliflozin (empa) in plasma after the first dose on day 1|5 minutes (min) before drug administration and 10 min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h after drug administration|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.||hours||Geometric Coefficient of Variation|Geometric Mean
838490|NCT01316341|Primary|Terminal Rate Constant (λz)|Terminal Rate Constant in Plasma (λz), after the first dose on day 1|5 minutes (min) before drug administration and 10 min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h after drug administration|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.||1/h||Geometric Coefficient of Variation|Geometric Mean
838491|NCT01316341|Primary|Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)|Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 to the time of the last quantifiable data point, after the first dose on day 1.|5 minutes (min) before drug administration and 10 min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h after drug administration|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
838492|NCT01316341|Primary|Area Under the Curve 0 to Infinity (AUC0-∞) After Single Dosing|Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity, after the first dose on day 1|5 minutes (min) before drug administration and 10 min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h after drug administration|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
838493|NCT01316341|Primary|Time to Maximum Measured Concentration (Tmax)|Time from dosing to the maximum measured concentration of the analyte in plasma, after the first dose on day 1.|5 minutes (min) before drug administration and 10 min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h after drug administration|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.||hours||Geometric Coefficient of Variation|Geometric Mean
838494|NCT01316341|Primary|Maximum Measured Concentration (Cmax)|Maximum measured concentration of the analyte in plasma after the first dose on day 1.|5 minutes (min) before drug administration and 10 min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h after drug administration|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
838495|NCT01316380|Secondary|Use of Rescue Medication During Nighttime|"Use of PRN (pro re nata, or as necessary) salbutamol/albuterol rescue medication (puffs during nighttime), determined as a weekly mean response from baseline for each week during the treatment period as well as for the last 7 days before treatment stop/Visit 5.
The mean was adjusted for treatment, centre, week, baseline, treatment*week and baseline*week."|Baseline and 12 weeks|All patients from FAS.||puffs of rescue medication||Standard Error|Mean
838496|NCT01316380|Secondary|Use of Rescue Medication During Daytime|"Use of PRN (pro re nata, or as necessary) salbutamol/albuterol rescue medication (puffs during daytime), determined as a weekly mean response from baseline for each week during the treatment period as well as for the last 7 days before treatment stop/Visit 5.
The mean was adjusted for treatment, centre, week, baseline, treatment*week and baseline*week."|Baseline and 12 weeks|All patients from FAS.||puffs of rescue medication||Standard Error|Mean
838497|NCT01316380|Secondary|Use of Rescue Medication During 24h Period|"Use of PRN (pro re nata, or as necessary) salbutamol/albuterol rescue medication (puffs during 24 h period), determined as a weekly mean response from baseline for each week during the treatment period as well as for the last 7 days before treatment stop/Visit 5.
The mean was adjusted for treatment, centre, week, baseline, treatment*week and baseline*week."|Baseline and 12 weeks|All patients from FAS.||puffs of rescue medication||Standard Error|Mean
838498|NCT01316380|Secondary|Time to First Asthma Exacerbation During the 12-week Treatment.|An asthma exacerbation was defined as an episode of progressive increase in 1 or more asthma symptom that were outside the patient's usual range of day-to-day asthma symptoms and lasted for at least 2 consecutive days or as a decrease in a patient's best morning PEF of 30% or more from a patient's mean morning PEF for at least 2 consecutive days that may or may not have been accompanied by symptoms.|12 weeks|All patients from FAS.||Days||Inter-Quartile Range|Median
838499|NCT01316380|Secondary|Time to First Severe Asthma Exacerbation During the 12-week Treatment.|Severe asthma exacerbations are defined as all asthma exacerbations that required treatment with systemic (including oral) corticosteroids for at least 3 days.|12 weeks|All patients from FAS.||Days||Inter-Quartile Range|Median
838500|NCT01316380|Secondary|Asthma Control Questionnaire (ACQ) Responder After 12 Weeks of Treatment|For the ACQ, the total score was calculated as the mean of the responses to 6 self administered questions and one question which was completed by clinical staff based upon pre-bronchodilator FEV1. The score ranges from 0 (no impairment) to 6 (maximum impairment). Response was categorised as: responder (change from baseline <= -0.5), no change (-0.5 <change from baseline < 0.5) and worsening (change from baseline >= 0.5).|12 weeks|All patients from FAS.||Number of patients|||Number
838501|NCT01316380|Secondary|FVC (AUC0-3h) Response at the End of the 12-week Treatment Period.|The AUC0-3h was calculated as area under the curve from zero to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. The trough value was assigned to zero time. Response was defined as change from baseline in FVC AUC0-3h after a treatment period of 12 weeks. MMRM results. Means are adjusted for treatment, pooled centre, visit, baseline, treatment*visit baseline*visit.|Baseline and 12 weeks|All patients from FAS.||Liter||Standard Error|Least Squares Mean
838502|NCT01316380|Secondary|FEV1 Area Under the Curve (AUC0-3h) Response at the End of the 12-week Treatment Period.|The AUC0-3h was calculated as area under the curve from zero to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. The trough value was assigned to zero time. Response was defined as change from baseline in FEV1 AUC0-3h after a treatment period of 12 weeks. MMRM results. Means are adjusted for treatment, pooled centre, visit, baseline, treatment*visit baseline*visit.|Baseline and 12 weeks|All patients from FAS.||Liter||Standard Error|Least Squares Mean
838503|NCT01316380|Secondary|Peak (Within 3 Hours Post-dosing) Forced Vital Capacity (FVC) Response at the End of the 12-week Treatment Period.|Peak FVC 0-3h response was defined as the difference between the maximum FVC measured within the first 3 hours post dosing after a treatment period of 12 weeks and the FVC baseline measurement (10 minutes before the first dose of trial medication). Mixed Model Repeated Measure (MMRM) results. Means are adjusted for treatment, pooled centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 12 weeks|All patients from FAS.||Liter||Standard Error|Least Squares Mean
838504|NCT01316380|Secondary|Trough FEV1 Response Determined After a Treatment Period of 12 Weeks.|The trough FEV1 is defined as the pre-dose FEV1 measured 10 minutes before the last administration of randomised treatment. Trough FEV1 response was defined as the difference between the trough FEV1 measured after a treatment period of 12 weeks and the trough FEV1 baseline measurement. MMRM results. Means are adjusted for treatment, pooled centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 12 weeks|All patients from FAS.||Liter||Standard Error|Least Squares Mean
838505|NCT01316380|Primary|Peak Forced Expiratory Volume in 1 Second (FEV1) Response Within 3 Hours Post Dosing (0-3h) After a Treatment Period of 12 Weeks.|Peak FEV1 0-3h response was defined as the difference between the maximum FEV1 measured within the first 3 hours post dosing after a treatment period of 12 weeks and the FEV1 baseline measurement (10 minutes before the first dose of trial medication). Mixed Model Repeated Measure (MMRM) results. Means are adjusted for treatment, pooled centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 12 weeks|All patients from Full Analysis Set (FAS) FAS is defined as all patients in the treated set who received at least one dose of randomized trial medication.||Liter||Standard Error|Least Squares Mean
838506|NCT01316419|Secondary|Incidence and Severity of Reported Adverse Events.|Incidence as per the severity of reported adverse events is presented.|24±2 weeks|Patients having received at least one dose of Twynsta tablets||participants|||Number
838507|NCT01316419|Secondary|Percentage of Patients Who Complied With Each Category of Lifestyle Modification Recommendations at 24±2 Weeks|Percentage of patients who complied with each category of lifestyle modification recommendations at 12±2 weeks|24±2 weeks|Patients with a baseline and an endpoint BMI together with evaluation record on recommendations for lifestyle modifications.||percentage of participants|||Number
838508|NCT01316419|Secondary|Percentage of Patients Who Complied With Each Category of Lifestyle Modification Recommendations at 12±2 Weeks|Percentage of patients who complied with each category of lifestyle modification recommendations at 12±2 weeks|12±2 weeks|Patients with a baseline and an endpoint BMI together with evaluation record on recommendations for lifestyle modifications.||percentage of participants|||Number
838509|NCT01316419|Secondary|Percentage of Patients Achieving Normal Body Mass Index (BMI)|Percentage of patients achieving normal BMI (18.5 kg/sq.m to 24.9 kg/sq.m) are presented|24±2 weeks|Patients with a baseline and an endpoint BMI together with evaluation record on recommendations for lifestyle modifications.||percentage of participants|||Number
838510|NCT01316419|Secondary|Mean Blood Lipid Change - Total Cholesterol|Mean blood lipid change - Total Cholesterol|baseline and 24±2 weeks|Patients with medical history of hyperlipidemia and who have a baseline and an endpoint lipid profile measurement together with evaluation record on recommendations for lifestyle modifications.||mg/dl||Standard Deviation|Mean
838511|NCT01316419|Secondary|Mean Blood Lipid Change - Triglyceride|Mean blood lipid change - Triglyceride|baseline and 24±2 weeks|Patients with medical history of hyperlipidemia and who have a baseline and an endpoint lipid profile measurement together with evaluation record on recommendations for lifestyle modifications.||mg/dl||Standard Deviation|Mean
838512|NCT01316419|Secondary|Mean Blood Lipid Change - High Density Lipoprotein (HDL)-Cholesterol|Mean blood lipid change from baseline - high density lipoprotein (HDL)-Cholesterol|baseline and 24±2 weeks|Patients with medical history of hyperlipidemia and who have a baseline and an endpoint lipid profile measurement together with evaluation record on recommendations for lifestyle modifications.||mg/dl||Standard Deviation|Mean
838513|NCT01316419|Secondary|Mean Blood Lipid Change - Low Density Lipoprotein (LDL)-Cholesterol|Mean blood lipid change from baseline - low density lipoprotein (LDL)-Cholesterol|baseline and 24±2 weeks|Patients with medical history of hyperlipidemia and who have a baseline and an endpoint lipid profile measurement together with evaluation record on recommendations for lifestyle modifications.||mg/dl||Standard Deviation|Mean
838514|NCT01316419|Secondary|Percentage of Patients Achieving SBP/DBP < 130/80 mmHg Among Patients With Diabetes or Kidney Disease|Percentage of patients achieving SBP/DBP < 130/80 mmHg among patients with diabetes or kidney disease|24±2 weeks|All patients with diabetes, kidney disease or both (diabetes + kidney disease)||percentage of participants|||Number
838515|NCT01316419|Secondary|EuroQol (EQ) Visual Analogue Scale (VAS)|The EQ VAS records the respondent’s self-rated health on a vertical, visual analogue scale where the endpoints are labelled ‘best imaginable health state’ and ‘worst imaginable health state. The scale goes from 0 to 100, a low value shows better physical health.|baseline and 24±2 weeks|Patients with a baseline and an endpoint EQ VAS response||scores on a scale||Standard Deviation|Mean
838516|NCT01316419|Secondary|Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Overall|"WHOQOL-BREF, an abbreviated 26 item version of the WHOQOL-100 was developed to enable a brief but accurate assessment of the quality of life.
The Korean version of WHOQOL-BREF is valid and reliable in the assessment of quality of life in Koreans. The WHOQOL-BREF is based on the four domain structure (physical health, psychological, social relationships, and environment). It was designed to use 5-point scales for all questions (not at all, a little, moderately, mostly, and completely). The scale goes from 4 to 20 in each domain structure and 0 to 5 in overall score, a low value shows better physical health."|baseline and 24±2 weeks|Patients with a baseline and an endpoint WHOQOL-BREF response||scores on a scale||Standard Deviation|Mean
838517|NCT01316419|Secondary|Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Environment Domain|"WHOQOL-BREF, an abbreviated 26 item version of the WHOQOL-100 was developed to enable a brief but accurate assessment of the quality of life.
The Korean version of WHOQOL-BREF is valid and reliable in the assessment of quality of life in Koreans. The WHOQOL-BREF is based on the four domain structure (physical health, psychological, social relationships, and environment). It was designed to use 5-point scales for all questions (not at all, a little, moderately, mostly, and completely). The scale goes from 4 to 20 in each domain structure and 0 to 5 in overall score, a low value shows better physical health."|baseline and 24±2 weeks|Patients with a baseline and an endpoint WHOQOL-BREF response||scores on a scale||Standard Deviation|Mean
838570|NCT01318967|Secondary|Measurement of Regional Blood Oxygenation by MRI|Estimate of renal blood flow by using MRI scans before and after the administration of furosemide|One measure after furosemide (day 1)|||ml/min||Full Range|Mean
838571|NCT01318967|Primary|Measurement of Renal Blood Flow of the Kidney by the PAH Method|Renal blood flow is estimated by the PAH method.|Renal blood flow is estimated over 1 hour by PAH|||ml/min||Full Range|Mean
838518|NCT01316419|Secondary|Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Social Relationships Domain|"WHOQOL-BREF, an abbreviated 26 item version of the WHOQOL-100 was developed to enable a brief but accurate assessment of the quality of life.
The Korean version of WHOQOL-BREF is valid and reliable in the assessment of quality of life in Koreans. The WHOQOL-BREF is based on the four domain structure (physical health, psychological, social relationships, and environment). It was designed to use 5-point scales for all questions (not at all, a little, moderately, mostly, and completely). The scale goes from 4 to 20 in each domain structure and 0 to 5 in overall score, a low value shows better physical health."|baseline and 24±2 weeks|Patients with a baseline and an endpoint WHOQOL-BREF response||scores on a scale||Standard Deviation|Mean
838519|NCT01316419|Secondary|Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Psychological Domain|"WHOQOL-BREF, an abbreviated 26 item version of the WHOQOL-100 was developed to enable a brief but accurate assessment of the quality of life.
The Korean version of WHOQOL-BREF is valid and reliable in the assessment of quality of life in Koreans. The WHOQOL-BREF is based on the four domain structure (physical health, psychological, social relationships, and environment). It was designed to use 5-point scales for all questions (not at all, a little, moderately, mostly, and completely). The scale goes from 4 to 20 in each domain structure and 0 to 5 in overall score, a low value shows better physical health."|baseline and 24±2 weeks|All patients with a baseline and an endpoint blood pressure measurement.||scores on a scale||Standard Deviation|Mean
838520|NCT01316419|Secondary|Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Physical Health Domain|"WHOQOL-BREF, an abbreviated 26 item version of the WHOQOL-100 was developed to enable a brief but accurate assessment of the quality of life.
The Korean version of WHOQOL-BREF is valid and reliable in the assessment of quality of life in Koreans. The WHOQOL-BREF is based on the four domain structure (physical health, psychological, social relationships, and environment). It was designed to use 5-point scales for all questions (not at all, a little, moderately, mostly, and completely). The scale goes from 4 to 20 in each domain structure and 0 to 5 in overall score, a low value shows better physical health."|baseline and 24±2 weeks|Patients with a baseline and an endpoint WHOQOL-BREF response||scores on a scale||Standard Deviation|Mean
838521|NCT01316419|Secondary|Percentage of Patients Achieving SBP Response|Percentage of patients achieving SBP response (defined as mean seated SBP < 140 mmHg or a drop of ≥ 10 mmHg) is a key secondary endpoint.|24±2 weeks|All patients with a baseline and an endpoint blood pressure measurement.||percentage of participants|||Number
838522|NCT01316419|Primary|Mean Blood Pressure Change Diastolic Blood Pressure (DBP) From Baseline After 24±2 Weeks of Treatment or at the Last Observation in Case of Early Withdrawal.|"The primary endpoint is the mean blood pressure change DBP from baseline after 24±2 weeks of treatment or at the last observation in case of early withdrawal.
Baseline is defined as data collected on baseline visit."|baseline and 24±2 weeks|All patients with a baseline and an endpoint blood pressure measurement.||mmHg||Standard Deviation|Mean
838523|NCT01316419|Secondary|Percentage of Patients Achieving DBP Response|Percentage of patients achieving DBP response (defined as mean seated DBP < 90 mmHg or a drop of ≥ 10 mmHg) is a key secondary endpoint.|24±2 weeks|All patients with a baseline and an endpoint blood pressure measurement.||percentage of participants|||Number
838524|NCT01316419|Secondary|Percentage of Patients Achieving Target Blood Pressure SBP/DBP <140/90 mmHg.|Percentage of patients achieving target blood pressure SBP/DBP <140/90 mmHg is a key secondary endpoint.|24±2 weeks|All patients with a baseline and an endpoint blood pressure measurement.||percentage of participants|||Number
838525|NCT01316419|Primary|Mean Blood Pressure Change Systolic Blood Pressure (SBP) From Baseline After 24±2 Weeks of Treatment or at the Last Observation in Case of Early Withdrawal.|"The primary endpoint is the mean blood pressure change SBP from baseline after 24±2 weeks of treatment or at the last observation in case of early withdrawal.
Baseline is defined as data collected on baseline visit."|baseline and 24±2 weeks|All patients with a baseline and an endpoint blood pressure measurement.||mmHg||Standard Deviation|Mean
838526|NCT01318499|Other Pre-specified|Cumulative Percentage of Patients Pain Free by Visit|Ocular pain was assessed by the patient on a 6-unit scale from 0 (none; absence of positive sensation), to 5 (severe; intense ocular, periocular or radiating pain requiring prescription analgesic). Pain free was defined as an ocular pain assessment score of 0. To be included in the cumulative summary at a visit, a patient must have been declared pain free at the visit and remained pain free at all subsequent visits.|Day 1, Day 3, Day 7, Day 14|All randomized patients with at least one postoperative assessment (intent-to-treat), last observation carried forward.||Percentage of patients|||Number
838527|NCT01318499|Other Pre-specified|Cumulative Percentage of Patients Cured by Visit|Ocular inflammation was assessed by the investigator during slit lamp examination. Aqueous cells were scored on a 5-unit scale from 0 (none) to 4 (> 30 cells), and aqueous flare (protein escaping from dilated vessels) was scored on a 4-unit scale from 0 (no visible flare when compared with the normal eye) to 3 (severe - very dense flare). To be considered cured, the patient must have had a score of 0 for both aqueous cells and aqueous flare. To be included in the cumulative summary at a visit, a patient must have been declared cured at the visit and remained cured at all subsequent visits.|Day 1, Day 3, Day 7, Day 14|All randomized patients with at least one postoperative assessment (intent-to-treat), last observation carried forward.||Percentage of patients|||Number
838528|NCT01318499|Post-Hoc|Cumulative Percent Clinical Success by Visit|Ocular inflammation was assessed by the investigator during slit lamp examination. Aqueous cells were scored on a 5-unit scale from 0 (none) to 4 (> 30 cells), and aqueous flare (protein escaping from dilated vessels) was scored on a 4-unit scale from 0 (no visible flare when compared with the normal eye) to 3 (severe - very dense flare). Clinical success occurred when the cell grade was ≤ 1 (0-5 cells) and flare grade was = 0. To be included in the cumulative summary at a visit, a patient must have been declared a clinical success at the visit and remained a clinical success at all subsequent visits.|Day 1, Day 3, Day 7, Day 14|All randomized patients with at least one post-operative assessment (intent-to-treat).||Percentage of patients|||Number
838595|NCT01319383|Secondary|Number of Participants With Measurable Changes in Plasma HIV-1 RNA|Assess for detectible HIV-1 RNA > 150 copies/mL, confirmed by repeat evaluation, following VOR dose. By standard assay and single copy assay. Pre specified to combine all participants into one arm.|1 week after last VOR dose|All participants receiving one or more doses of VOR in any and all Arms of the study.||Participants|||Count of Participants
838529|NCT01318499|Secondary|Percentage of Patients Cured at Day 7, Nepafenac 0.3% vs. Nepafenac 0.1%|Ocular inflammation was assessed by the investigator during slit lamp examination. Aqueous cells were scored on a 5-unit scale from 0 (none) to 4 (> 30 cells), and aqueous flare (protein escaping from dilated vessels) was scored on a 4-unit scale from 0 (no visible flare when compared with the normal eye) to 3 (severe - very dense flare). To be considered cured, the patient must have had a score of 0 for both aqueous cells and aqueous flare.|Day 7 postoperative|All randomized patients with at least one postoperative assessment (intent-to-treat), last observation carried forward.||Percentage of patients|||Number
838530|NCT01318499|Primary|Percentage of Patients Cured at Day 14, Nepafenac 0.3% vs. Nepafenac Vehicle 0.3%|Ocular inflammation was assessed by the investigator during slit lamp examination. Aqueous cells were scored on a 5-unit scale from 0 (none) to 4 (> 30 cells), and aqueous flare (protein escaping from dilated vessels) was scored on a 4-unit scale from 0 (no visible flare when compared with the normal eye) to 3 (severe - very dense flare). To be considered cured, the patient must have had a score of 0 for both aqueous cells and aqueous flare.|Day 14 postoperative|All randomized patients with at least one postoperative assessment (intent-to-treat), last observation carried forward.||Percentage of patients|||Number
838531|NCT01318512|Primary|Average Dose of MIRCERA During Maintenance Period Month 6|The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.|Month 10 (Maintenance Period Month 6)|All participants who received at least one dose of MIRCERA during the maintenance period.||microgram (µg)||Standard Deviation|Mean
838532|NCT01318512|Primary|Average Dose of MIRCERA During Maintenance Period Month 5|The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.|Month 9 (Maintenance Period Month 5)|All participants who received at least one dose of MIRCERA during the maintenance period.||microgram (µg)||Standard Deviation|Mean
838533|NCT01318512|Primary|Average Dose of MIRCERA During Maintenance Period Month 4|The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.|Month 8 (Maintenance Period Month 4)|All participants who received at least one dose of MIRCERA during the maintenance period.||microgram (µg)||Standard Deviation|Mean
838534|NCT01318512|Primary|Average Dose of MIRCERA During Maintenance Period Month 3|The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.|Month 7 (Maintenance Period Month 3)|All participants who received at least one dose of MIRCERA during the maintenance period.||microgram (µg)||Standard Deviation|Mean
838535|NCT01318512|Primary|Average Dose of MIRCERA During Maintenance Period Month 2|The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.|Month 6 (Maintenance Period Month 2)|All participants who received at least one dose of MIRCERA during the maintenance period.||microgram (µg)||Standard Deviation|Mean
838536|NCT01318512|Primary|Average Dose of MIRCERA During Maintenance Period Month 1|The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.|Month 5 (Maintenance Period Month 1)|All participants who received at least one dose of MIRCERA during the maintenance period.||microgram (µg)||Standard Deviation|Mean
838537|NCT01318512|Primary|Average Dose of MIRCERA During Titration Period Month 4|The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the titration period was reported.|Month 4|All participants who received at least one dose of MIRCERA during titration period.||microgram (µg)||Standard Deviation|Mean
838538|NCT01318512|Primary|Average Dose of MIRCERA During Titration Period Month 3|The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the titration period was reported.|Month 3|All participants who received at least one dose of MIRCERA during titration period.||microgram (µg)||Standard Deviation|Mean
838539|NCT01318512|Primary|Average Dose of MIRCERA During Titration Period Month 2|The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the titration period was reported.|Month 2|All participants who received at least one dose of MIRCERA during titration period.||microgram (µg)||Standard Deviation|Mean
838540|NCT01318512|Primary|Average Dose of MIRCERA During Titration Period Month 1|The average dose of MIRCERA, measured in microgram (µg) at each month interval during the titration period was reported.|Month 1|All participants who received at least one dose of MIRCERA during titration period.||microgram (µg)||Standard Deviation|Mean
838541|NCT01318512|Secondary|The Mean Hemoglobin (Hb) Level During Maintenance Period|The hemoglobin level was measured in grams per liter (g/L) after each month of treatment with MIRCERA. The study did not distinguish between erythropoiesis stimulating agent naive and erythropoiesis stimulating agent treated participants, and collected the overall data (Hb level) before/after administration of MIRCERA|Month 5, 6, 7, 8, 9, 10|All participants who received at least one dose of MIRCERA during maintenance period.||g/L||Standard Deviation|Mean
838542|NCT01318512|Secondary|The Mean Hemoglobin (Hb) Level During Titration Period|The hemoglobin level was measured in grams per liter (g/L) at entry level and after each month of treatment with MIRCERA. The study did not distinguish between erythropoiesis stimulating agent naive and erythropoiesis stimulating agent treated participants, and collected the overall data (Hb level) before/after administration of MIRCERA.|Baseline, Month 1, 2, 3, 4|All participants who received at least one dose of MIRCERA during titration period.||g/L||Standard Deviation|Mean
838543|NCT01318512|Primary|Average Dose of MIRCERA at Entry Level|The average dose of MIRCERA, measured in micrograms (µg) at entry level was reported.|Baseline|All participants who received at least one dose of MIRCERA during the titration period.||microgram (µg)||Standard Deviation|Mean
838544|NCT01318538|Secondary|Change in Mean Drinks Per Drinking Day for Women|This represents the change from baseline in the mean number of drinks per drinking day. Drinks per drinking day was assessed using the Timeline Follow-Back at baseline and then monthly for 9 months. The In-Treatment phase includes months 1-3, the 3 Month Post-Treatment phase includes months 4-6, and the 6 Month Post-Treatment phase includes months 7-9. The in-treatment and 2 post-treatment phases were compared to baseline data of mean drinks per drinking day. Outcomes were analyzed using loglinear (negative binomial) regression models with estimation via generalized estimating equations (GEE). The models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction.|In-treatment (months 1-3), 3 Month Post-treatment (months 4-6), 6 Month Post-Treatment (months 7-9)|Only women were included in this analysis.||change in mean drinks per drinking day||95% Confidence Interval|Mean
838545|NCT01318538|Secondary|Percent Change in Mean Heavy Drinking Days for Women|This represents the percent change from baseline in the mean number of heavy drinking days for women. Number of heavy drinking days was assessed using the Timeline Follow-Back at baseline and then monthly for 9 months. The In-Treatment phase includes months 1-3, the 3 Month Post-Treatment phase includes months 4-6, and the 6 Month Post-Treatment phase includes months 7-9. The in-treatment and 2 post-treatment phases were compared to baseline data of mean heavy drinking days. Outcomes were analyzed using loglinear (negative binomial) regression models with estimation via generalized estimating equations (GEE). The models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction.|In-treatment (months 1-3), 3 Month Post-treatment (months 4-6), 6 Month Post-Treatment (months 7-9)|Only women were included in this analysis.||% change in mean heavy drinking days||95% Confidence Interval|Mean
838546|NCT01318538|Secondary|Percent Change in Mean Drug Use Days for Women|This represents the percent change from baseline in the mean number of drug use days (excluding alcohol) for women. Days of drug use was assessed using the Timeline Follow-Back at baseline and then monthly for 9 months. The In-Treatment phase includes months 1-3, the 3 Month Post-Treatment phase includes months 4-6, and the 6 Month Post-Treatment phase includes months 7-9. The in-treatment and 2 post-treatment phases were compared to baseline data of mean drug use days. Outcomes were analyzed using loglinear (negative binomial) regression models with estimation via generalized estimating equations (GEE). The models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction.|In-treatment (months 1-3), 3 Month Post-treatment (months 4-6), 6 Month Post-Treatment (months 7-9)|Only women were included in this analysis.||% change in mean drug use days||95% Confidence Interval|Mean
838547|NCT01318538|Other Pre-specified|Group Stability|Treatment group stability was calculated using the Percentage of Group Change Index which captures change in group membership composition from session to session separately for each individual within each group (specific to the calendar period that each person was in the group). The value can range from 0 (i.e., the exact same membership from one session to the next) to 1 (i.e., complete turnover in membership). The average values across all sessions were taken to get an overall sense of the amount of turnover each person experienced in the group during the period in calendar time they were in treatment.|In treatment (weeks 1-12)|Only women were included in this analysis.||units on a scale||Standard Deviation|Mean
838548|NCT01318538|Other Pre-specified|Group Attendance|Treatment attendance was calculated by summing the number of treatment sessions attended. Therefore, numbers range from 0-12.|In treatment (weeks 1-12)|Only women were included in this analysis.||sessions attended||Standard Deviation|Mean
838549|NCT01318538|Other Pre-specified|Therapist Adherence|All therapists were female to eliminate any therapist-patient gender matching effects. There were eight therapists in total: 4 who led WRG groups and 4 who led GDC groups. All group sessions were videotaped each week so that we could measure therapist adherence to the treatment they were assigned to. Two independent raters completed adherence scales for a random selection of 20% of WRG and 10%of GDC sessions. For both groups, the extensiveness to which the therapist engaged in a behavior during the session was rated with a 5-point Likert scale (0 = not at all; 4 = extensively). Adherence scores were calculated by averaging all scores for each question (25 questions for WRG; 18 for GDC) on the measure. The scores reported here represent the average of all WRG therapists scores from all session, and all GDC therapist scores from all sessions. Scores range from 0 to 4.|In treatment (weeks 1-12)|||units on a 0-4 adherence scale|Sessions|Standard Deviation|Mean
838550|NCT01318538|Primary|Change in Mean ASI Drug Composite Score for Women|"This represents the change from baseline in mean ASI Drug composite scores. The ASI was administered at baseline, at months 1-6, and then at month 9. The In-Treatment phase includes months 1-3, the 3 Month Post-Treatment phase includes months 4-6, and the 6 Month Post-Treatment phase includes months 7-9. The in-treatment and 2 post-treatment phases were compared to baseline ASI data. Outcomes were analyzed using linear mixed effect models. These models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction.
The ASI is a multidimensional assessment of substance-related problems which yields composite scores for alcohol use, drug use, psychiatric status, medical status, legal status, family/social relationships, and employment status. Composite scores range from 0 to 1, with higher scores indicating more significant problems."|In-treatment (months 1-3), 3 Month Post-treatment (months 4-6), 6 Month Post-Treatment (months 7-9)|Only women were included in this analysis.||change in ASI Drug composite score||95% Confidence Interval|Mean
838551|NCT01318538|Primary|Change in Mean ASI Alcohol Composite Score for Women|"This represents the change from baseline in mean ASI Alcohol composite scores. The ASI was administered at baseline, at months 1-6, and then at month 9. The In-Treatment phase includes months 1-3, the 3 Month Post-Treatment phase includes months 4-6, and the 6 Month Post-Treatment phase includes months 7-9. The in-treatment and 2 post-treatment phases were compared to baseline ASI data. Outcomes were analyzed using linear mixed effect models. These models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction.
The ASI is a multidimensional assessment of substance-related problems which yields composite scores for alcohol use, drug use, psychiatric status, medical status, legal status, family/social relationships, and employment status. Composite scores range from 0 to 1, with higher scores indicating more significant problems."|In-treatment (months 1-3), 3 Month Post-treatment (months 4-6), 6 Month Post-Treatment (months 7-9)|Only women were included in this analysis.||change in ASI Alcohol composite score||95% Confidence Interval|Mean
838552|NCT01318538|Secondary|Percent Change in Mean Alcohol Use Days for Women|This represents the percent change from baseline in the mean number of alcohol use days. Days of alcohol use was assessed using the Timeline Follow-Back at baseline and then monthly for 9 months. The In-Treatment phase includes months 1-3, the 3 Month Post-Treatment phase includes months 4-6, and the 6 Month Post-Treatment phase includes months 7-9. The in-treatment and 2 post-treatment phases were compared to baseline alcohol use data. Outcomes were analyzed using loglinear (negative binomial) regression models with estimation via generalized estimating equations (GEE). The models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction.|In-treatment (months 1-3), 3 Month Post-treatment (months 4-6), 6 Month Post-Treatment (months 7-9)|Some participants did not complete this measure at the specified time points. Only women were included in this analysis.||percent change in Alcohol Use Days||95% Confidence Interval|Mean
839187|NCT01324687|Secondary|Cost of Care|Comparison of cost of care between intervention and control groups.|Up to 36 months|The cost data was not available from the Finance Office from Rochester General Hospital or Thompson Hospital so this analysis was not performed.|||||
838553|NCT01318538|Primary|Percent Change in Mean Days of Any Substance Use for Women|This represents the percent change from baseline in the mean number of days per month of any substance use (i.e. drug and/or alcohol) for women. Days of substance use was assessed using the Timeline Follow-Back at baseline and then monthly for 9 months. The In-Treatment phase includes months 1-3, the 3 Month Post-Treatment phase includes months 4-6, and the 6 Month Post-Treatment phase includes months 7-9. The in-treatment and 2 post-treatment phases were compared to baseline data of mean days of any substance use. Outcomes were analyzed using loglinear (negative binomial) regression models with estimation via generalized estimating equations (GEE). The models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction.|In-treatment (months 1-3), 3 Month Post-treatment (months 4-6), 6 Month Post-Treatment (months 7-9)|Only women were included in this analysis.||% change in mean substance use days||95% Confidence Interval|Mean
838554|NCT01318694|Secondary|Percentage of Participants With Grade 3 or 4 Thrombocytopenia During Treatment Within 48 Weeks|Grading was according to the DMID Toxicity Tables (version 2.0). Participants with multiple abnormalities were counted only once in the worst category.|within 48 weeks|Participants in the Safety Set with available data||percentage of participants|||Number
838555|NCT01318694|Secondary|Percentage of Participants With Grade 3 or 4 Neutropenia During Treatment Within 48 Weeks|Grading was according to the DMID Toxicity Tables (version 2.0). Participants with multiple abnormalities were counted only once in the worst category.|within 48 weeks|Participants in the Safety Set with available data||percentage of participants|||Number
838556|NCT01318694|Secondary|Percentage of Participants With Grade 3 or 4 Anemia During Treatment Within 48 Weeks|"Grading was according to the Modified Division of Microbiology & Infectious Diseases (DMID) Toxicity Tables (version 2.0).
Participants with multiple abnormalities were counted only once in the worst category."|within 48 weeks|Participants in the Safety Set with available data||percentage of participants|||Number
838557|NCT01318694|Secondary|Percentage of Participants With Alanine Aminotransferase (ALT) Abnormalities Within 48 Weeks|"ALT abnormalities were summarized as participants who had either:
ALT > 2 x upper limit of normal (ULN) during the study and > 2 x ULN at baseline
ALT > 3 x ULN during the study and > 2 x ULN at baseline"|within 48 weeks|Participants in the Safety Set, defined as having received at least one dose of study medication, with available data||percentage of participants|||Number
838558|NCT01318694|Secondary|Percentage of Participants With End of Treatment Response (ETR) at Treatment End Within 48 Weeks|ETR was defined as serum HCV RNA < LOQ at treatment end (completed or prematurely discontinued).|at treatment end within 48 weeks|Participants in the Full Analysis Set with available data||percentage of participants|||Number
838559|NCT01318694|Secondary|Percentage of Participants With Extended Rapid Virologic Response (eRVR) From 4 to 12 Weeks of Treatment|eRVR was defined as achieving RVR4 and maintaining HCV RNA < LOQ until Week 12.|from 4 to 12 weeks of treatment|Participants in the Full Analysis Set with available data||percentage of participants|||Number
838560|NCT01318694|Secondary|Percentage of Participants With Complete Early Virologic Response (cEVR) After 12 Weeks of Treatment|cEVR was defined as serum HCV RNA < LOQ after 12 weeks of treatment.|after 12 weeks of treatment|Participants in the Full Analysis Set with available data||percentage of participants|||Number
838561|NCT01318694|Secondary|Percentage of Participants With Partial Early Virologic Response (pEVR) After 12 Weeks of Treatment|pEVR was defined as a ≥ 2 log10 decrease in HCV RNA and still detectable (≥ LOQ) after 12 weeks of treatment.|after 12 weeks of treatment|Participants in the Full Analysis Set with available data||percentage of participants|||Number
838562|NCT01318694|Secondary|Percentage of Participants With Early Virologic Response (EVR) After 12 Weeks of Treatment|EVR was defined as a ≥ 2 log10 decrease in HCV RNA or HCV RNA < LOQ after 12 weeks of treatment.|after 12 weeks of treatment|Participants in the Full Analysis Set with available data||percentage of participants|||Number
838563|NCT01318694|Secondary|Percentage of Participants With Rapid Virologic Response (RVR) After 4 Weeks of Treatment (RVR4)|RVR4 was defined as serum HCV RNA < LOQ after 4 weeks of treatment.|after 4 weeks of treatment|Participants in the Full Analysis Set with available data||percentage of participants|||Number
838564|NCT01318694|Secondary|Percentage of Participants Who Achieved SVR 24 Weeks After the End of Treatment (SVR24)|SVR24 was defined as HCV RNA laboratory value < LOQ 24 weeks after the end of treatment.|24 weeks after the end of treatment|Participants in the Full Analysis Set with available data||percentage of participants|||Number
838565|NCT01318694|Primary|Percentage of Participants Who Achieved Sustained Virologic Response (SVR) 12 Weeks After the End of Treatment (SVR12)|SVR12 was defined as hepatitis C virus (HCV) RNA laboratory value below the level of quantification (< LOQ; i.e., 25 IU/ml) 12 weeks after the end of treatment.|12 weeks after the end of treatment|Full Analysis Set||percentage of participants|||Number
838566|NCT01318733|Primary|Long Term Safety & Efficacy of CD07805/47 Gel 0.5% in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea.|"Static evaluation of erythema severity using the Clinician Erythema Assessment (CEA) - Grade/Description 0 / Clear Skin with no signs of erythema
/ Almost clear; slight redness
/ Mild erythema; definite redness
/ Moderate erythema; marked redness
/ Severe erythema; fiery redness
Change in CEA from Baseline CEA (T0 at Baseline visit Day 1) at T3 of each post-baseline visit, including Day 1."|Over 1 year|||scores on a scale||Standard Deviation|Mean
838567|NCT01318876|Primary|Number of Participants Who Had Experienced a New Health Problem or the Worsening of an Existing Health Condition That Resulted in Work Absenteeism.||day 8 and 29|||participants|||Number
838568|NCT01318876|Primary|Number of Participants Who Had Experienced a New Health Problem or the Worsening of an Existing Health Condition That Resulted in a Medical Consultation||at day 8 and 29|||participants|||Number
838569|NCT01318915|Primary|Percentage of Participants Successfully Withdrawn From Immunosuppression and Remain Off Immunosuppression for at Least 52 Weeks.|Participants are considered as successfully withdrawn from immunosuppression if they remain off immunosuppression for at least 52 weeks without evidence of rejection, as determined by a biopsy performed 52 weeks after completion of immunosuppression withdrawal. All participants who fail to complete immunosuppression withdrawal, regardless of reason, or fail to have a biopsy 52 weeks after completion of immunosuppression withdrawal will be considered to have failed. The endpoint will be summarized with a two-sided, 95% exact binomial confidence interval.|Transplantation through 52 weeks after stopping all immunosuppression.|Transplanted Participants||percentage of participants||95% Confidence Interval|Number
838572|NCT01318993|Secondary|Change From Baseline (Week 0) in Inflammatory Bowel Disease Questionnaire (IBDQ), Short Form Health Survey (SF-36) Version 2, EuroQol 5 Dimensional (EQ-5D), Work and Productivity Activity Impairment-Crohn's Disease (WPAI-CD) and Disability Over 112 Weeks|IBDQ, SF-36, EQ-5D, WPAI-CD, and disability scores were all health outcome related scores that were based on assessment of participants based on different questionnaire. Each scoring scale had different range and participants were planned to be rated separately based on each scale.|Baseline (Week 0) and up to 112 weeks|ITT population was planned to be analyzed for this study. However, this outcome measure was not analyzed due to termination of study and no data was collected for this outcome measure.|||||
838573|NCT01318993|Secondary|Percentage of Participants Achieving Response (CDAI Decrease of at Least 100 Points From Baseline ([Week 0] of Prior Induction Study) in the Sub-population of Non-responders at Study Entry Over 112 Weeks|The CDAI score was determined by interactive voice response relationship (IVRS) based on the combination of participant and investigator entries and standardized weight determination. Haematocrit values received from the central laboratory on the day of the visit were to be utilized for calculation of the CDAI scores. The Baseline (Week 0) CDAI score was defined as the last evaluation prior to or on the date the first dose of investigational product was taken. Remissions are defined as subjects with CDAI score of < 150 points. Percentages are based on the number of subjects with observed data. No imputation for missing data was performed.|Baseline (Week 0) and up to 112 weeks|ITT population was planned to be analyzed for this study.However, this outcome measure was not analyzed due to termination of study and no data was collected for this outcome measure.|||||
838574|NCT01318993|Secondary|Percentage of Participants in Clinical Remission (CDAI Score Less Than 150) for All Participants, for Participants in Remission at Baseline (Week 0), and for Participants Not in Remission at Baseline Over 108 Weeks|The CDAI score was determined by interactive voice response relationship (IVRS) based on the combination of participant and investigator entries and standardized weight determination. Haematocrit values received from the central laboratory on the day of the visit were to be utilized for calculation of the CDAI scores. The Baseline (Week 0) CDAI score was defined as the last evaluation prior to or on the date the first dose of investigational product is taken. The CDAI score was measured over 108 weeks although it was planned to be measured till 112 weeks. Remissions are defined as subjects with CDAI score of < 150 points. Percentages are based on the number of subjects with observed data. No imputation for missing data was performed. Combined data for participants with remission at Baseline and without remission at Baseline has been presented.|Baseline (Week 0) and up to 108 weeks|Safety population. Only the participants available at the time of assessment were analyzed.||Participants||95% Confidence Interval|Number
838575|NCT01318993|Secondary|Change From Baseline (Week 0) in Crohn’s Disease Activity Index (CDAI) Score Over 108 Weeks|The CDAI score was determined by interactive voice response relationship (IVRS) based on the combination of participant,investigator entries, standardized weight determination, and Hematocrit values received from the central laboratory. The Baseline CDAI score was recorded pre-dose on Week 0. Change from Baseline is the value at indicated time point minus the Baseline value. Remissions are defined as participants with CDAI score of < 150 points. No imputation for missing data was performed. The assessment was based on questionnaire like number of liquid stool in past 7 days, abdominal pain, other symptoms, antidiarrheal use, abdominal mass, anemia, and body weight. The total score is summation of all individual sub-scores. CDAI scoring scale ranges from 0-500 and a score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline (Week 0) and up to 108 weeks|Safety population. Only the participants available at the time of assessment were analyzed.||Scores on a scale||Standard Deviation|Mean
838576|NCT01318993|Secondary|Number of Participants With the Indicated Change From Baseline (Week 0) in Corrected QT Interval (QTc) Value|QTc is the corrected QT interval as measured by the electrocardiogram (ECG). ECG parameters including the change from Baseline in the QTc interval values QTcF and QTcB were summarised. The QTcF is Fridericia’s formula and defined as the QT interval/cubed root of the R-R interval. The QTcB is the Bazett’s formula defined as the QT/squared root of the R-R interval. The number of participants with change from Baseline in the QTcF and QTcB intervals of >30, 30 to <60 and >=60 milliseconds were assessed at Week 24, 48, 72, 108, and Week 112. The last value on or prior to the treatment start date was considered the Baseline value (Week 0). Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.|Baseline (week 0) and Weeks 24, 48, 72, 108, and 112 (4 weeks post treatment)|Safety Population. Only participants available at the specified time points were analyzed.||Participants|||Count of Participants
838577|NCT01318993|Secondary|Change From Baseline (Week 0) in Albumin|Change from Baseline in albumin was assessed to monitor liver function. Blood samples were taken at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72, 84, 96, 108, and 4 Weeks post treatment. The last value on or prior to the treatment start date (Week 0) was considered the Baseline value. Change from Baseline was calculated as the post-Baseline value at the time point indicated minus the value at Baseline.|Baseline (Week 0) and up to Week 112|Safety Population. Only participants available at the specified time points were analyzed.||Grams/Liter (G/L)||Standard Deviation|Mean
838578|NCT01318993|Secondary|Change From Baseline (Week 0) in Total Bilirubin|Changes from Baseline (Week 0) in total bilirubin (TB) was assessed to monitor liver function. Blood samples were taken at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72, 84, 96, 108, and 4 Weeks post-treatment. The last value on or prior to the treatment start date was considered the Baseline value. Change from Baseline was calculated as the post-Baseline value at the time point indicated minus the value at Baseline.|Baseline (Week 0) and up to Week 112|Safety Population. Only participants available at the specified time points were analyzed.||micromole/Liter||Standard Deviation|Mean
838579|NCT01318993|Secondary|Change From Baseline (Week 0) in ALT, AST, ALP, and GGT as a Function of Liver Function Test (LFT)|Changes in Baseline in ALP, ALT, AST, and GGT were assessed to monitor liver function. Blood samples were taken at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72, 84, 96, 108, and 4 Weeks post-treatment. The last value on or prior to the treatment start date was considered the Baseline value. Change from Baseline was calculated as the post-Baseline value at the time point indicated minus the value at Baseline.|Baseline (Week 0) and up to Week 112|Safety Population. Only participants available at the specified time points were analyzed.||International Unit per Liter (IU/L)||Standard Deviation|Mean
838580|NCT01318993|Secondary|Number of Participants With Shifts From Baseline (Week 0) for the Indicated Clinical Chemistry Parameters|Clinical chemistry parameters included platelets, total protein, phosphorous, albumin, sodium, potassium, chloride, calcium, glucose, gamma-glutamyl transferase, total bilirubin (TB), direct bilirubin (DB), alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen (BUN)/urea, creatinine, uric acid, bicarbonate, lactate dehydrogenase, cholesterol, alkaline phosphatase (ALP), gamma glutamyl transferases (GGT), and creatine kinase. The Baseline value is defined as the value obtained at Week 0. The number of participants with the indicated clinical chemistry parameters' data reference range shifts from Baseline (defined as shift to low, shift to normal or no change, or shift to high) until 4 weeks post-treatment are presented.|Baseline (Week 0) and up to Week 112|Safety Population. Only participants available at the specified time points were analyzed.||Participants|||Count of Participants
838581|NCT01318993|Secondary|Number of Participants With Shifts From Baseline (Week 0) for the Indicated Hematology Parameters|Hematology parameters measured included platelets, neutrophils (NL), lymphocytes, monocytes, eosinophils, basophils, hematocrit, band cells, red blood cell (RBC) count, hemoglobin, white blood cell (WBC) count, and segmented (seg) NL. The Baseline value is defined as the value obtained at Week 0. The number of participants with the indicated hematology parameters data reference range shifts from Baseline (defined as shift to low, shift to normal or no change, shift to high) until 4 weeks post treatment are presented.|Baseline (Week 0) and up to Week 112|Safety Population. Only the participants available at the time of analysis were included.||Participants|||Count of Participants
838582|NCT01318993|Secondary|Change From Baseline (Week 0) in Heart Rate (HR) Over Period|The HR values were obtained as part of vital sign monitoring and measured after the participant was at rest in the supine position for at least 5 minutes. Change from Baseline in HR was assessed at Week 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108 and 4 weeks post-treatment. The Baseline value is defined as the value at Week 0. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.|Baseline (week 0) and up to Week 112|Safety Population. Only participants available at the specified time points were analyzed.||beats per minute||Standard Deviation|Mean
838583|NCT01318993|Secondary|Change From Baseline (Week 0) in Systolic and Diastolic Blood Pressure (SBP and DBP) Over Period|The SBP and DBP values were obtained as part of vital sign monitoring and measured after the participant was at rest in the supine position for at least 5 minutes. Baseline value was recorded at Week 0. Change from Baseline measurements in SBP and DBP were assessed at Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108 and 4 weeks post-treatment. The Baseline value is defined as the value at Week 0. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.|Baseline (Week 0) and up to Week 112|Safety Population. Only participants available at the specified time points were analyzed.||millimeters of mercury (mmHg)||Standard Deviation|Mean
838584|NCT01318993|Primary|Number of Participants With Any Adverse Events (AE) and Any Serious Adverse Events (SAE)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect. The Safety population consisted of all participants who enrolled in the study except those who did not take >=1 dose of investigational product.|Up to Week 112|Safety Population||Participants|||Count of Participants
838585|NCT01319045|Secondary|Quality of Life|Change in quality of life as assessed by SF-36 QOL|3 months|unable to analyze because study was terminated prematurely and therefore follow up assessments were not obtained|||||
838586|NCT01319045|Secondary|Serum Brain Natriuretic Peptide (BNP)|Change in serum BNP level|3 months|unable to analyze because study was terminated prematurely and therefore follow up assessments were not obtained|||||
838587|NCT01319045|Secondary|Exercise Capacity|Change in exercise duration (modified Bruce protocol), maximal oxygen consumption (VO2 max), and/or VE/VCO2 ratio.|3 months|unable to analyze because study was terminated prematurely and therefore follow up assessments were not obtained|||||
838588|NCT01319045|Primary|Safety and Tolerability|Number of Participants with adverse events, specifically mortality and heart failure.|3 months|Number of adverse events.||participants|||Number
838589|NCT01319110|Secondary|Comparison of Serum CoQ10 Levels Randomized to Supplementation vs. Placebo|The secondary outcome will be to compare serum CoQ10 levels among those post-arrest patients randomized to CoQ10 supplementation vs placebo.|1 year|This data was not collected when the study was performed|||||
838590|NCT01319110|Primary|Prevalence of Low Serum CoQ10 Levels in Cardiac Arrest Patients|The primary outcome will be describing the prevalence of low serum CoQ10 levels compared to standard laboratory control values.|Baseline|||ug/mL||Standard Deviation|Mean
838591|NCT01319318|Primary|Percentage of Participants With Vitreous Cell Count of 0|The study eye was dilated and the investigator used an instrument to count the number of visible cells in the vitreous, the jelly-like fluid that fills the back of the eye, using the following scale: 0 (no cells) best, +1 (1-10 cells), +2 (11-30 cells), +3 (31-50 cells) and +4 (>50 cells) worst.|Week 4|Intent to treat population included all randomized participants.||Percentage of participants|||Number
838592|NCT01319383|Other Pre-specified|Number of Participants Developing Cancer Within 5 Years Following >/= 8 Vorinostat Dose Exposures|Development of a new cancer within the 5 years of taking their last dose of VOR 400 mg PO.All participants receiving one or more doses of VOR 400 mg PO in any and all Arms of the study. Pre-specified to be reported as one group.|From last dose Vorinostat to 5 years afterwards|At end of study, participants receiving >/= 8 doses of Vorinostat are enrolled in a 5-year cancer incidence database to be monitored for the occurrence of cancer.||Participants|||Count of Participants
838593|NCT01319383|Secondary|Number of Participants With Confirmed Hematologic Toxicity >/= Grade 2 and Related to VOR Per Division of AIDS (DAIDS) Grading Table|DAIDS Grading Table- Grade 1- mild, Grade 2- moderate; Grade 3- severe Grade 4- potentially life-threatening. Pre specified to combine all participants into one arm.|24 hrs following single dose and 1 week after last of multiple dose sequence|All participants receiving one or more doses of VOR 400 mg PO in any and all Arms of the study.||Participants|||Count of Participants
839188|NCT01324687|Primary|Emergency Department Use|Use of emergency department by individuals with access to care via telemedicine as compared to those without such access to care.|Up to 42 months|||Emergency dept use rate per person-month|||Number
838596|NCT01319383|Primary|Number of Participants Exhibiting an in Vivo Resting CD4+ T-cell-associated HIV RNA (Rc-RNA) Increase Following Multiple (n = 10) Interval Doses|Participants in Arm 2, Step 4 were analyzed for an in vivo increase in the resting CD4+ T cell- associated HIV RNA (RCVL) after administration of 10 doses of VOR 400 mg PO, given 72 hours apart.|Baseline, Visit 9|Participants who demonstrated a significant in vivo response after taking 2 doses of VOR 400 mg PO, each dose taken 72 hours apart were administered 10 doses of VOR based on the optimal dosing of 72 hours.||Participants|||Count of Participants
838597|NCT01319383|Primary|Number of Participants With a Significant in Vivo Response in Resting Cell Infection (RCI) and HIV RNA After Paired Doses|Induction of significant in vivo RCI and RCLV response after 2 doses of VOR 400 mg PO administered 48 hours apart or 72 hours apart|Baseline, Visit 6|Participants showing an in vivo response in resting CD4+ T cell- associated HIV RNA (RCVL) after a single dose of VOR were administered 2 doses of VOR 400 mg separated by either 48 or 72 hours to determine the optimal interval/spacing to observe a significant in vivo response in the RCVL after the paired doses.||Participants|||Count of Participants
838598|NCT01319383|Primary|Number of Participants Exhibiting an in Vivo Resting CD4+ T-cell-associated HIV RNA (Rc-RNA) Increase Following Each of Two Multiple Dose Cycles (11 Doses/Cycle)|Participants in Arm 1, Step 3 were analyzed for an in vivo increase in the resting CD4+ T cell- associated HIV RNA (RCVL) after 11 doses of VOR 400 mg PO. This cycle was repeated after a 5 - 8 week rest period for a 2nd series and measurement.|Baseline, Visit 18, Visit 29|Participants with resting CD4+ T-cell-associated HIV RNA (rc-RNA) increases after receiving daily VOR Monday through Wednesday for 8 weekly cycles were enrolled.||Participants|||Count of Participants
838599|NCT01319383|Primary|Number of Participants Exhibiting an in Vivo Resting CD4+ T Cell- Associated HIV RNA (RCVL) Increase After Receiving a Single Dose of VOR 400 mg PO|Participants in Arm 1 and 2 were analyzed in Step 2 for an in vivo increase in resting CD4+ T cell- associated HIV RNA (RCVL) after administration of a single dose of VOR 400 mg PO|Arm1: Baseline, Visit 5 and Arm 2: Baseline and Visit 3|||Participants|||Count of Participants
838600|NCT01319396|Primary|Accuracy of Breathing Rate Measurement|accuracy of breathing rate indicated by the BiancaMed BM07 device, compared to that indicated by Somnoscreen to be +/- 5 breaths per minute (95% confidence)|2 minutes|Each participant gives 8 test points, thus with 22+ participants, there are >160 test points, which is sufficient to give a standard deviation.||breaths per minute||Standard Deviation|Mean
838601|NCT01319422|Secondary|To Correlate Drug Induced Changes in F Actin With Cytokine Profile.|Correlation to be determined upon completion of study treatment|Research blood draw will be obtained at baseline, and at 2-4 hr (on day 1), 1 wk, and 4 wk after initiation of cycles 1 and 2.|The actin polymerization assay that was to be used for this outcome was not reproducible; hence, the cytokine profile of actin polymerized cells could not be pursued. Data were not analyzed.|||||
838602|NCT01319422|Secondary|To Correlate Drug Induced Changes in F Actin Polymerization With Adverse Effects and Clinical Responses.|Research bone marrow aspirate is obtained to assess response (optional, but recommended), and to document complete remission, if applicable. Correlation to be determined upon completion of study treatment|Research bone marrow aspirate is obtained at baseline and after completion of 2 cycles of therapy (approximately 56 days)|The actin polymerization assay that was to be used for this outcome was not reproducible and data were not analyzed.|||||
838603|NCT01319422|Secondary|To Compare the Effect of Continuous Versus Intermittent Regimens on F Actin Polymerization in Peripheral Blood Mononuclear Cells and Activation of Tumor Antigen-specific T Cells, as Well as Innate Lymphocytes (Natural Killer or Natural Killer T Cells).|Correlation to be determined upon completion of study treatment|Research blood draw will be obtained at baseline, and at 2-4 hr (on day 1), 1 wk, and 4 wk after initiation of cycles 1 and 2.|N/A: data were not collected on this outcome; initial F actin polymerization assay was unreliable and not reproducible; hence, this outcome could not be pursued.|||||
838604|NCT01319422|Primary|Percentage of Participants With Response, Analyzed Per International Myeloma Working Group Response Criteria|All partial and complete responses must be confirmed with another efficacy assessment in no less than 4 weeks apart.|After the initial efficacy assessment at the completion of cycle 2 (at approximately 56 days), efficacy assessments will be made after every other cycle (approximately every 56 days).|||percentage of participants|||Number
838605|NCT01319422|Primary|Percentage of Participants With Response, Analyzed Per International Myeloma Working Group Response Criteria|All partial and complete responses must be confirmed with another efficacy assessment in no less than 4 weeks apart.|Efficacy assessments will be made after the first two cycles of therapy (approximately 56 days--each cycle is 28 days)|||percentage of participants|||Number
838606|NCT01319500|Primary|Reasons for OC Prescriptions by Gynecologists and Dermatologists||February 2009 - March 2009|||number of participants|||Number
838607|NCT01319500|Primary|Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for Non-contraceptive Reasons Only)|"Exclusively non-contraceptive reasons for OC prescriptions (no contraception intended; category non-contraceptive reasons only"|February 2009 - March 2009|||number of participants|||Number
838608|NCT01319500|Primary|"Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for Contraceptive and Non-contraceptive and Non-contraceptive Only Reasons"|"Non-contraceptive reasons for OC prescriptions (including both categories: contraception plus non-contraceptive reasons and non-contraceptive reasons only"|February 2009 - March 2009|||number of participants|||Number
838609|NCT01319500|Primary|Reasons for OC Prescriptions|The main reasons for OC prescription: contraception only; contraception combined with non-contraceptive reasons; non-contraceptive reasons only.|February 2009 - March 2009|||percentage of participants||95% Confidence Interval|Number
838610|NCT01319500|Primary|OC Prescriptions by Treatment Group and Prescribing Medical Specialists|Prescriptions of Yasmin and Other OCs by different physicians (private gynecologists, public gynecologists and dermatologists)|February 2009 - March 2009|||Prescribing physicians|||Number
838611|NCT01319539|Secondary|Change in Ki-67 Expression|This is designed to evaluate response to therapy - comparing changes within group (example: invasive pre-MK-2206-treated core versus post-MK-2206-treated surgical tissue).|Baseline, 2 weeks (Day 0 - surgery)|Of the 12 participants enrolled and received study treatment, there were 7 participants with evaluable matched core and surgical specimen tissue.||percentage of cells||Standard Deviation|Mean
839189|NCT01324882|Primary|Time to Intubate the Cecum|The time in seconds that it required to intubate the cecum as defined in our protocol.|This outcome was measured the day of the procedure.|||seconds||Standard Deviation|Mean
838612|NCT01319539|Secondary|Change in pS6 Levels|This is designed to evaluate response to therapy - comparing changes within group (example: invasive pre-MK-2206-treated core versus post-MK-2206-treated surgical tissue).|Baseline, 2 weeks (Day 0 - surgery)|Of the 12 participants enrolled and received study treatment, there were 7 participants with evaluable matched core and surgical specimen tissue.||percentage of cells||Standard Deviation|Mean
838613|NCT01319539|Primary|Change in pAKT Levels|This is designed to evaluate response to therapy - comparing changes within group (example: invasive pre-MK-2206-treated core versus post-MK-2206-treated surgical tissue).|Baseline, 2 weeks (Day 0 - surgery)|Of the 12 participants enrolled and received study treatment, there were 7 participants with evaluable matched core and surgical specimen tissue.||percentage of cells||Standard Deviation|Mean
838614|NCT01319552|Primary|Measure of Non-transferrin-bound Iron|"Comparison of increase in non-transferrin-bound iron for each participant between his or her fresh and old blood transfusion four hours after transfusion."|four hours after transfusion|||μM||Standard Deviation|Mean
838615|NCT01319617|Primary|Ocular Discomfort|Ocular discomfort in the study eye is reported by patients on a 100-mm visual analog scale (left end 0 mm, no discomfort; right end 100 mm, very severe discomfort) as the distance from the left end to the patient's mark after wearing the device for 24 hours at two occasions separated by one week. Values for both sessions were averaged.|After 24 hours of device wear|||mm||Standard Deviation|Mean
838616|NCT01319721|Secondary|Postoperative Conjunctival Inflammation|The presence of conjunctival inflammation around the surgical site was assessed at 4 weeks post-operatively and graded as 0 (none), i (mild), ii (moderate), and iii (severe).|One month|||eyes|Participants||Number
838617|NCT01319721|Secondary|Eye Movement Amplitude (EMA)||One Year|||millimeter|Participants|Standard Deviation|Mean
838618|NCT01319721|Secondary|Healing Time of Corneal Epithelial Defect||Four Weeks|||days|Participants|Standard Deviation|Mean
838619|NCT01319721|Secondary|Complications||One year|||eyes|Participants||Number
838620|NCT01319721|Primary|Recurrence|Recurrence was defined as the presence of fibrovascular tissue in the surgical area and invasion onto the cornea. The appearance of the surgical bed in successful cases was graded as follows: grade A was defined as the operated eye being indistinguishable from a normal eye, grade B was defined as the presence of fine episcleral vessels without fibrous tissue in the surgical area extending up to the limbus but not beyond, and grade C was defined as the presence of fibrovascular tissue in the surgical area but without invasion onto the cornea.|One Year|||eyes|Participants||Number
838621|NCT01319773|Secondary|Number of Eyes With Ocular Symptoms Post-Dose During the Paired-Eye Phase (PEP) at Day 1|Number of eyes with ocular symptoms of any severity, post-dose in the paired-eye phase (PEP) at Day 1. Subjects evaluated the presence and severity of ocular symptoms in each eye. The severity of each symptom (blurring, foreign body sensation, pain, burning/stinging, tearing, and itching) were recorded on a 5-point scale (0=none, +0.5=very mild, +1=mild, +2=moderate, and +3=severe).|Day 1|Per Protocol: All randomized subjects who received their assigned study medication and closely followed the protocol.||Number of Eyes|Participants||Number
838622|NCT01319773|Secondary|Number of Subjects Who Reported Ocular Symptoms During the Parallel-Group Phase (PGP)|Number of subjects who reported ocular symptoms of any severity during the parallel-group phase (PGP) of the study. Subjects evaluated the presence and severity of ocular symptoms in each eye. The severity of each symptom (blurring, foreign body sensation, pain, burning/stinging, tearing, and itching) were recorded on a 5-point scale (0=none, +0.5=very mild,+1=mild, +2=moderate, and +3=severe).|3 Days|Per Protocol: All randomized subjects who received their assigned study medication and closely followed the protocol.||Number of Subjects|||Number
838623|NCT01319773|Primary|Concentration of Cyclosporine Measured in Blood at Day 1 in the Parallel-Group Phase (PGP)|Concentration of cyclosporine measured in blood at Day 1 of the parallel-group phase (PGP). Blood samples were collected up to 3 hours post-dose and concentrations of cyclosporine were measured.|Day 1|Safety Population: All randomized subjects who were treated with at least 1 dose of study medication.||Nanogram/milliliter (ng/mL)|||Number
838624|NCT01319799|Secondary|Cerebrospinal Fluid(CSF) Levels of S-100B(Microgram/Liter)|"Differences in preoperative vs postoperative CSF levels of S-100B in microgram/Liter
The assumption is that a cardiac open heart surgical procedure with cardiopulmonary bypass will influence the postoperative level of marker of neuronal cell damage in the central nerve system. An increase in the levels, compared to the preoperative values, indicates neuronal cell damage detectable in the CSF, namely the brains own extracellular fluid."|24 Hours after Surgery|||microgram/Liter||Standard Error|Mean
838625|NCT01319799|Primary|Transcranial Doppler(TCD) Microembolic Signals During Surgical Aortic Valve Replacement Surgery|Transcranial Doppler measurement of microembolic signals will be measured during the surgical procedure.Microembolic signals are detected by offline analysis of the Dopplerspectral analysis of the blood flow in the medial cerebral artery. Different intensities (dB),flow direction and time frame appearances in the Doppler spectral envelope is distinguishable for a neurosonolgist according to predefined criteria for an embolic signal-defined in previous litterature.The total amount of signals during one surgical procedure is counted. The appearance of microembolic signals related to specific procedures performed during cardiac surgery with cardiopulmonary bypass is noted. The exact time range is not possible to estimate in advance,due to the fact that each surgical procedure varies in time.The range of values for each individual patient, based on pilos, will vary from 50 to approximately 1500 embolic counts for one surgical procedure. A high value is negative for the patient.|(day 1) TCD will be performed from start of surgery till end of surgery-exact time cannot be stated in advance|||units on a scale||Standard Error|Mean
838626|NCT01319812|Secondary|Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - 30-day Clinical Success|Compare the 30-day clinical success results between evaluable subjects treated with standard length lesions (between 20 mm and 140 mm) and evaluable subjects treated for long lesions (between 141 mm and 190 mm) for the Pulsar stent group.|30 days|Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.||Percentage of participants|||Number
838627|NCT01319812|Secondary|Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Acute Procedure Success|Compare the acute procedure success results between evaluable subjects treated with standard length lesions (between 20 mm and 140 mm) and evaluable subjects treated for long lesions (between 141 mm and 190 mm) for the Pulsar stent group.|Acute / Date of Procedure|Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.||Percentage of participants|||Number
838628|NCT01319812|Secondary|Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Secondary Patency Rate at 12 Months|Compare the secondary patency rate at 12 months between evaluable subjects treated with standard length lesions (between 20 mm and 140 mm) and evaluable subjects treated for long lesions (between 141 mm and 190 mm) for the Pulsar stent group.|12 months|Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.||Percentage of participants|||Number
838629|NCT01319812|Secondary|Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Primary Assisted Patency at 12 Months|Compare the primary assisted patency rate at 12 months between evaluable subjects treated with standard length lesions (between 20 mm and 140 mm) and evaluable subjects treated for long lesions (between 141 mm and 190 mm) for the Pulsar stent group.|12 months|Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.||Percentage of participants|||Number
838630|NCT01319812|Secondary|Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Stent Fracture Rate at 12 Months|Compare the stent fracture rate at 12 months between evaluable subjects treated with standard length lesions (between 20 mm and 140 mm) and evaluable subjects treated for long lesions (between 141 mm and 190 mm) for the Pulsar stent group.|12 months|Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.||Percentage of participants|||Number
838631|NCT01319812|Secondary|Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Primary Patency at 12 Months|Compare the primary patency rate at 12 months between evaluable subjects treated with standard length lesions (between 20 mm and 140 mm) and evaluable subjects treated for long lesions (between 141 mm and 190 mm) for the Pulsar stent group.|12 months|Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.||Percentage of participants|||Number
838632|NCT01319812|Secondary|Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - MAE Rate|Compare the MAE rate results between evaluable subjects treated with standard length lesions (between 20 mm and 140 mm) and evaluable subjects treated for long lesions (between 141 mm and 190 mm) for the Pulsar stent group.|12 months|Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.||Percentage of participants|||Number
838633|NCT01319812|Secondary|Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - 30-Day Clinical Success|Compare the 30-day clinical success results between evaluable subjects treated for occlusive lesions (100% stenosis) and evaluable subjects treated for non-occlusive lesions (70% - 99% stenosis) for the Astron stent and the Pulsar stent group.|30 days|Includes all participants who underwent implantation.||Percentage of participants|||Number
838634|NCT01319812|Secondary|Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - Acute Procedure Success|Compare the acute procedure success results between evaluable subjects treated for occlusive lesions (100% stenosis) and evaluable subjects treated for non-occlusive lesions (70% - 99% stenosis) for the Astron stent and the Pulsar stent group.|Acute / Date of Procedure|Includes all participants who underwent implantation.||Percentage of participants|||Number
838635|NCT01319812|Secondary|Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - Secondary Patency Rate at 12-Months|Compare the secondary patency (freedom from bypass and amputation of the target limb) at 12-months results between evaluable subjects treated for occlusive lesions (100% stenosis) and evaluable subjects treated for non-occlusive lesions (70% - 99% stenosis) for the Astron stent and the Pulsar stent group.|12 months|Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.||Percentage of participants|||Number
838636|NCT01319812|Secondary|Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - Primary Assisted Patency at 12-Months|Compare the primary assisted patency (freedom from remote TVR) at 12-months results between evaluable subjects treated for occlusive lesions (100% stenosis) and evaluable subjects treated for non-occlusive lesions (70% - 99% stenosis) for the Astron stent and the Pulsar stent group.|12 months|Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.||Percentage of participants|||Number
838637|NCT01319812|Secondary|Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - Primary Patency at 12-months|Compare the primary patency at 12-months results between evaluable subjects treated for occlusive lesions (100% stenosis) and evaluable subjects treated for non-occlusive lesions (70% - 99% stenosis) for the Astron stent and the Pulsar stent group.|12 months|Includes all participants who underwent successful implantation and had a 12-month evaluable duplex ultrasound assessment.||Percentage of participants|||Number
838638|NCT01319812|Secondary|Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - 30 Day MAE Rate|Compare the 30 day MAE rate results between evaluable subjects treated for occlusive lesions (100% stenosis) and evaluable subjects treated for non-occlusive lesions (70% - 99% stenosis) for the Astron stent and the Pulsar stent group.|30 days|Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.||Percentage of participants|||Number
838639|NCT01319812|Secondary|Secondary Safety Assessment for Astron and Pulsar Stent: Adverse Event Rates|Evaluate the rates of all individual adverse event types that are not included in the primary endpoint analyses for the Astron stent and the Pulsar stent group. Please see the Serious Adverse Events and Other Adverse Events sections for event details.|12 month|Includes all participants who underwent implantation.||Participants with event|||Number
838640|NCT01319812|Secondary|Clinical Success|Evaluate the 30-day clinical success of the procedure. The 30-day clinical success is defined as completion of the assigned procedure, the stented lesion having less than 30% residual stenosis determined by angiography immediately after stent placement and no MAEs within 30 days of the index procedure.|30 days|The Astron stent group includes all participants who underwent implantation. The Pulsar stent group includes all participants who underwent implantation except for one, due to subject death occurring in the first 30 days.||Percentage of participants||95% Confidence Interval|Number
838641|NCT01319812|Secondary|Acute Procedural Success for Astron and Pulsar Stent|Evaluate the acute procedural success of the Astron and Pulsar stent. Acute procedural success is defined as completion of the assigned procedure, the stented lesion having less than 30% residual stenosis determined by angiography immediately after stent placement and no MAEs before hospital discharge.|30 days|Includes all participants who underwent implantation.||Percentage of participants||95% Confidence Interval|Number
838642|NCT01319812|Secondary|Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire Stair Climbing Score|"The purpose of this endpoint is to compare Walking Impairment Questionnaire Stair Climbing score between baseline and 12 months post-index procedure. The WIQ is a subjective questionnaire completed by participants at baseline and the 12 month visit which asks questions about mobility to assess walking impairment. Larger numbers indicate better outcomes, with a minimum score of 0 and a maximum score of 100. Please see the following publication for further information:
Hiatt WR, Hirsch AT, Regensteiner JG, et al. Clinical Trials for Claudication. Assessment of Exercise Performance, Functional Status, and Clinical Endpoints. Vascular Clinical Trialists. Circulation. 1995;92:614-621"|12 months|Analysis conducted on paired data. WIQ stair climbing scores were available for 142 participants from both baseline and the 12-month visit for the Astron stent group. WIQ stair climbing scores were available for 255 participants from both baseline and the 12-month visit for the Pulsar stent group.||Units on a scale (WIQ score)||Standard Deviation|Mean
838643|NCT01319812|Secondary|Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire Walking Speed Score|"The purpose of this endpoint is to compare Walking Impairment Questionnaire Walking Speed score between baseline and 12 months post-index procedure. The WIQ is a subjective questionnaire completed by participants at baseline and the 12 month visit which asks questions about mobility to assess walking impairment. Larger numbers indicate better outcomes, with a minimum score of 0 and a maximum score of 100.. Please see the following publication for further information:
Hiatt WR, Hirsch AT, Regensteiner JG, et al. Clinical Trials for Claudication. Assessment of Exercise Performance, Functional Status, and Clinical Endpoints. Vascular Clinical Trialists. Circulation. 1995;92:614-621"|12 months|Analysis conducted on paired data. WIQ walking speed scores were available for 143 participants from both baseline and the 12-month visit for the Astron stent group. WIQ walking speed scores were available for 263 participants from both baseline and the 12-month visit for the Pulsar stent group.||Units on a scale (WIQ score)||Standard Deviation|Mean
838644|NCT01319812|Secondary|Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire Walking Distance Score|"The purpose of this endpoint is to compare Walking Impairment Questionnaire Walking Distance score between baseline and 12 months post-index procedure. The WIQ is a subjective questionnaire completed by participants at baseline and the 12 month visit which asks questions about mobility to assess walking impairment. Larger numbers indicate better outcomes, with a minimum score of 0 and a maximum score of 100.. Please see the following publication for further information:
Hiatt WR, Hirsch AT, Regensteiner JG, et al. Clinical Trials for Claudication. Assessment of Exercise Performance, Functional Status, and Clinical Endpoints. Vascular Clinical Trialists. Circulation. 1995;92:614-621"|12 months|Analysis conducted on paired data. WIQ walking distance scores were available for 144 participants from both baseline and the 12-month visit for the Astron stent group. WIQ walking distance scores were available for 264 participants from both baseline and the 12-month visit for the Pulsar stent group.||Units on a scale (WIQ score)||Standard Deviation|Mean
838645|NCT01319812|Secondary|Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire PAD Specific Score|"The purpose of this endpoint is to compare Walking Impairment Questionnaire (WIQ) Peripheral Arterial Disease (PAD) specific score between baseline and 12 months post-index procedure. The WIQ is a subjective questionnaire completed by participants at baseline and the 12 month visit which asks questions about mobility to assess walking impairment. Larger numbers indicate better outcomes, with a minimum score of 0 and a maximum score of 100. Please see the following publication for further information:
Hiatt WR, Hirsch AT, Regensteiner JG, et al. Clinical Trials for Claudication. Assessment of Exercise Performance, Functional Status, and Clinical Endpoints. Vascular Clinical Trialists. Circulation. 1995;92:614-621"|12 months|Analysis conducted on paired data. WIQ PAD responses were available for 143 participants from both baseline and the 12-month visit for the Astron stent group. WIQ PAD responses were available for 265 participants from both baseline and the 12-month visit for the Pulsar stent group.||Units on a scale (WIQ score)||Standard Deviation|Mean
838646|NCT01319812|Secondary|Functional Assessments for Subjects With the Astron and Pulsar Stents - Six-Minute Walk Test|The purpose of this endpoint is to compare the distance walked during the 6-minute walk test between baseline and 12 months post-index procedure.|12 months|Analysis conducted on paired data. Six-minute walk test results were available for 131 participants from both baseline and the 12-month visit for the Astron stent group. Six-minute walk test results were available for 247 participants from both baseline and the 12-month visit for the Pulsar stent group.||Feet||Standard Deviation|Mean
838647|NCT01319812|Secondary|Functional Assessments for Subjects With the Astron and Pulsar Stents - Ankle - Brachial Index (ABI) Measurement|The purpose of this endpoint is to compare the ABI measurements between baseline and 12 months post-index procedure. ABI is the ratio of systolic blood pressure of ankle relative to systolic blood pressure of arm.|12 months|Analysis conducted on paired data. ABI measurements were available for 141 participants from both baseline and the 12-month visit for the Astron stent group. ABI measurements were available for 266 participants from both baseline and the 12-month visit for the Pulsar stent group.||Ratio (ABI score)||Standard Deviation|Mean
838648|NCT01319812|Secondary|Secondary Effectiveness Assessment for the Astron and Pulsar Stents - Secondary Patency|Evaluate the secondary patency rate (freedom from bypass and amputation of the target limb) for the Astron and Pulsar stent at 12 months post-index procedure.|12 months|Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.||Percentage of participants||95% Confidence Interval|Number
838649|NCT01319812|Secondary|Secondary Effectiveness Assessment for the Astron and Pulsar Stents - Primary Assisted Patency|Evaluate the primary assisted patency rate (freedom from remote Target Vessel Revascularization [TVR]) for the Astron and Pulsar stent at 12 months post-index procedure.|12 months|Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.||Percentage of participants||95% Confidence Interval|Mean
838650|NCT01319812|Secondary|Secondary Effectiveness Assessment for the Astron Stent - Primary Patency Rate|Evaluate the primary patency of the Astron stent at 12 months post-index procedure as measured by duplex ultrasound. Primary patency is defined as freedom from more than 50% restenosis based on the duplex ultrasound peak systolic velocity ratio, comparing data within the treated segment to the proximal normal segment or based on a clinically-indicated TLR with angiographic evidence of > 50% stenosis.|12 months|Includes all participants who underwent successful implantation and had a 12-month evaluable duplex ultrasound assessment.||Percentage of participants||95% Confidence Interval|Mean
838651|NCT01319812|Secondary|Secondary Safety Assessment for the Astron Stent - Distribution of MAE Rate|Evaluate the contribution of the individual rates of 30-day mortality and 12-month target lesion revascularization and index limb amputation rates to the primary endpoint for the Astron stent.|12 months|Includes all participants who underwent successful implantation and either met the 30-day mortality categorization or completed a 12-month evaluation.||Percentage of participants||95% Confidence Interval|Mean
838652|NCT01319812|Secondary|Stent Integrity Assessment for the Pulsar Stent: Stent Fracture Rate|Evaluate the Pulsar stent integrity as measured by x-ray at 12 months post-index procedure. An independent angiographic core laboratory reviewed x-ray imaging for presence or absence of a stent fracture. Fractures were assessed with Grade I indicating a single tine fracture, Grade II indicating multiple tine fracture, Grade III indicating stent fracture(s) with preserved alignment of the components, Grade IV indicating stent fracture(s) with mal-alignment of the components, and Grade V stent fracture(s) in a trans-axial spiral configuration. Generally, fractures of Grade I are least severe, increasing in severity to Grade V.|12 months|Participants with 12 month (395 day) diagnostic X-ray available for fracture evaluation.||Participants|||Count of Participants
838653|NCT01319812|Secondary|Long-Term Safety Assessment for the Pulsar Stent: Major Adverse Event Rate|Evaluate the long-term major adverse event rate of the Pulsar stent. Likewise, the endpoint will evaluate the contribution of the individual rates of 30-day mortality and 12-month target lesion revascularization and index limb amputation rates to this overall, long-term major adverse event rate.|12 months|Participants who reached at least 395 calendar days post procedure.||Percentage of participants||95% Confidence Interval|Number
838654|NCT01319812|Secondary|Secondary Safety Assessment for the Pulsar Stent: Individual Rates of Mortality, TLR, and Index Limb Amputation|Evaluate the contribution of the individual rates of mortality, target lesion revascularization (TLR) and index limb amputation at 30 days post-index procedure to the primary safety endpoint for the Pulsar stent.|30 days|All participants implanted with an Astron Pulsar or Pulsar-18 stent.||Percentage of participants||95% Confidence Interval|Number
838655|NCT01319812|Primary|Safety and Effectiveness Endpoint for the Astron Stent - Percentage of Participants With Major Adverse Events (MAE)|The primary endpoint for the Astron stent is a composite of the rate of procedure- or stent-related major adverse events at 12 months post-index procedure. The major adverse event rate includes 30-day mortality, along with 12-month rates of target lesion revascularization and index limb amputation. Success was measured against a performance goal of 15%, given a 7.5% expected 12-month MAE rate, with an assumed delta value of 7.5%.|12 months|Includes all participants who underwent successful implantation and either met the 30-day mortality categorization or completed a 12-month evaluation.||Percentage of participants||95% Confidence Interval|Mean
838656|NCT01319812|Primary|Safety Endpoint for the Pulsar Stent: Freedom From Procedure- or Stent-related Major Adverse Events|The primary safety endpoint for the Pulsar stent is the freedom from procedure- or stent-related major adverse events at 30 days post-index procedure. The major adverse event rate includes mortality, target lesion revascularization and index limb amputation.|30 days|All participants implanted with an Astron Pulsar or Pulsar-18 stent.||Percentage of participants||95% Confidence Interval|Number
838657|NCT01319812|Primary|Effectiveness Endpoint for the Pulsar Stent: Primary Patency|The primary effectiveness endpoint for the Pulsar stent group is the primary patency rate at 12 months post-index procedure. Primary patency is defined as freedom from more than 50% restenosis based on the duplex ultrasound peak systolic velocity ratio, comparing data within the treated segment to the proximal normal segment or based on a clinically-indicated TLR with angiographic evidence of > 50% stenosis.|12 months|Participants for whom patency could be confirmed at 12 months.||Percentage of participants||95% Confidence Interval|Number
838658|NCT01319851|Secondary|Number of Participants Who Experienced Chronic Graft-versus-host Disease (cGVHD), Measured by the NIH Criteria Consensus (NCC)|The severity criteria of chronic graft-versus-host disease (cGVHD) recommended by the NIH Criteria Consensus (NCC) was employed. The number of organs involved and the severity of the disease in these organs dictated the global summary score used to define the disease as mild, moderate, or severe. Mild disease indicates one or two organs involved each with a maximal score of 1. Moderate disease indicates three or more organs involved with a score of 2 in any individual organ, or lung involvement with a score of 1. Severe global GVHD is defined by a score of 3 in any organ, or a lung score of 2.|Day 100 post-transplant|||participants|||Number
838659|NCT01319851|Secondary|Number of Participants Who Experienced Acute Graft-versus-host Disease (aGVHD), Measured by NIH Consensus Criteria (NCC) Score: Grade II-IV|Cumulative Incidence of Grade II-IV aGVHD Score at 30 Days. The NIH Consensus grading and severity criteria includes physical assessments of skin, oral cavity, eyes, gynecological and laboratory data and patient reports. Each domain is scored from Grade 0 (no involvement) to Grade IV (severe involvement).|Day 30 post-transplant|||participants|||Number
838660|NCT01319851|Secondary|Incidence of 100% CD33 Donor Chimerism|CD33 chimerism was measured from peripheral blood lymphocytes 30 days post transplant. DNA chimerism analysis was performed by amplified fragment length polymorphism.|Day 30 post-transplant|||participants|||Number
838661|NCT01319851|Secondary|Incidence of Greater Than or Equal to 85% CD3 Donor Chimerism|CD3 chimerism was measured from peripheral blood lymphocytes 30 days post transplant. DNA chimerism analysis was performed by amplified fragment length polymorphism.|Day 30 post-transplant|||participants|||Number
838662|NCT01319851|Secondary|Number of Participants That Expressed Successful Neutrophil Engraftment|Neutrophil engraftment was assessed with absolute neutrophils >500*10^8/kg by 100 days post transplant. Neutrophils were counted by performing a complete blood cell count (CBC).|Day 100 post-transplant|||participants|||Number
839190|NCT01324882|Primary|Intubation of Cecum|The ability of endoscopist to intubate the cecum with enough control of the tip to abut the appendix or begin to retroflex in the cecum.|(day 1) Within time for performance of colonoscopy||||||
838663|NCT01319851|Secondary|Number of Participants That Expressed Grade 2 or 3 Regimen-Related Toxicity|Regimen-related toxicity was measured using the Bearman criteria. The Bearman criteria grades toxicity levels at Grade 1, Grade 2, Grade 3, and Grade 4. In this system, grade I toxicity is reversible without treatment and grade 2 is not life threatening, but requires treatment. Grade 3 requires life-support intervention and grade 4 is fatal. All regimen-related toxicities were determined to be unlikely attributable to the study drug.|Day 42 post-transplant|||participants|||Number
838664|NCT01319851|Primary|Feasibility of Alefacept Pre-conditioning, Measured by Number of Subjects With Full Donor Engraftment|All subjects received alefacept prior to hematopoietic stem cell transplantation and were followed up to at least two years after transplantation to ensure successful engraftment.|Two years post-transplant|||participants|||Number
838665|NCT01319877|Secondary|Quality of Life: European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire|Quality of life was assessed at baseline and every three months after treatment by the EORTC QLQ-C30 questionnaire. The possible score range was 0 to 100, with a higher score indicating better functioning.|Up to 36 Months|Evaluable participants.||score on a scale||Standard Deviation|Mean
838666|NCT01319877|Secondary|One-year Survival Rate by the Chemotherapy Regimen Subgroup||1 year|Participants with known prior chemotherapy regimens were evaluated||percentage of participants||95% Confidence Interval|Number
838667|NCT01319877|Secondary|One-year Progression-free Survival Rate Per Chemotherapy Regimen Subgroup|One year progression-free survival rate was defined as the percentage of participants who were free of progression or death from the date when the participant signed the informed consent form to one year. Results are reported per participants' chemotherapy regimen subgroup.|1 year|Participants with known prior chemotherapy regimens were evaluated.||percentage of participants||95% Confidence Interval|Number
838668|NCT01319877|Secondary|Percentage of Participants Achieving an Overall Response by the Chemotherapy Regimen Subgroup|Overall response was defined as complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR: Disappearance of all target lesions, all non-target lesions, and no new lesions. PR: At least a 30% decrease in the sum of the diameters of target lesions, no progression in non-target lesions, and no new lesions. Results are reported per participants' chemotherapy regimen subgroup.|Up to 36 Months|Participants with known prior chemotherapy regimens were evaluated||percentage of participants||95% Confidence Interval|Number
838669|NCT01319877|Secondary|One-year Survival Rate by the KRAS Subgroup||1 year|Participants with known KRAS status were evaluated||percentage of participants||95% Confidence Interval|Number
838670|NCT01319877|Secondary|One-year Progression-free Survival Rate Per KRAS Subgroup|One year progression-free survival rate was defined as the percentage of participants who were free of progression or death from the date when the participant signed the informed consent form to one year. Results are reported per participants' Kirsten Rat Sarcoma Viral (KRAS) oncogene subgroup.|1 year|Participants with known KRAS status were evaluated.||percentage of participants||95% Confidence Interval|Number
838671|NCT01319877|Secondary|Percentage of Participants Achieving an Overall Response Per Kirsten Rat Sarcoma Viral (KRAS) Oncogene Subgroup|Overall response was defined as complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR: Disappearance of all target lesions, all non-target lesions, and no new lesions. PR: At least a 30% decrease in the sum of the diameters of target lesions, no progression in non-target lesions, and no new lesions. Results are reported per participants' Kirsten Rat Sarcoma Viral (KRAS) oncogene subgroup.|36 months|Participants with known KRAS status were evaluated.||percentage of participants||95% Confidence Interval|Number
838672|NCT01319877|Secondary|One-year Survival Rate||1 year|||percentage of participants||95% Confidence Interval|Number
838673|NCT01319877|Secondary|One-year Progression-free Survival Rate|One year progression-free survival rate was defined as the percentage of participants who were free of progression or death from the date when the participant signed the informed consent form to one year.|1 year|||percentage of participants||95% Confidence Interval|Number
838674|NCT01319877|Secondary|Progression-free Survival|Progression-free-survival (PFS) was defined as the time from the date when the participant signed the informed consent form to the time of first documented disease progression or death, whichever occurred first.|36 months|||months||95% Confidence Interval|Median
838675|NCT01319877|Secondary|Percentage of Participants Achieving an Overall Response|Overall response was defined as complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR: Disappearance of all target lesions, all non-target lesions, and no new lesions. PR: At least a 30% decrease in the sum of the diameters of target lesions, no progression in non-target lesions, and no new lesions.|36 months|||percentage of participants||95% Confidence Interval|Number
838676|NCT01319877|Primary|Percentage of Participants With Bevacizumab-related Serious Adverse Events||36 months|||percentage of participants|||Number
838677|NCT01319877|Primary|Percentage of Participants With Bevacizumab-Related Adverse Events||36 months|||percentage of participants|||Number
838678|NCT01319877|Primary|Percentage of Participants With Adverse Events of Special Interest||36 months|||percentage of participants|||Number
838679|NCT01319877|Primary|Percentage of Participants With Serious Adverse Events|A Serious Adverse Event (SAE) was any untoward medical occurrence that at any dose was fatal, required inpatient hospitalization or prolongation of an existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was medically significant, or required intervention to prevent one or other of the outcomes listed above.|36 months|||percentage of participants|||Number
838680|NCT01319877|Primary|Percentage of Participants With Adverse Events|An adverse event (AE) is defined as any untoward medical occurrence in a participant after administration of a pharmaceutical product and which did not necessarily have a causal relationship with this treatment.|36 months|||percentage of participants|||Number
838684|NCT01320137|Secondary|Number of Subject Responders With Antigen-Th2 CD4+ T Cells Expressing IFN-γ - Amended Definition|Responders to a specific cytokine were defined as subjects with concentration for that respective cytokine after Bet v 1 stimulation above P95 of the concentration for that cytokine after medium only stimulation for all subjects (Total cohort), AND at least 5 times higher than their own respective concentration after medium only stimulation.|At Day 0|The According-To-Protocol (ATP) cohort, Bet v 1 BrdU+ subjects included all subjects from the ATP cohort for which proliferation of peripheral blood mononuclear cells (PBMCs) with the birch pollen allergen Bet v 1 was observed after 96 hours.||Subjects|||Number
838685|NCT01320137|Secondary|Number of Subject Responders With Antigen-Th2 CD4+ T Cells Expressing Interferon-gamma (IFN-γ)|Responders are defined as subjects with a concentration after Bet v 1 stimulation above P95 (determined on Bet v 1 BrdU+ subjects) of all concentrations after medium only stimulation|At Day 0|The According-To-Protocol (ATP) cohort, Bet v 1 BrdU+ subjects included all subjects from the ATP cohort for which proliferation of peripheral blood mononuclear cells (PBMCs) with the birch pollen allergen Bet v 1 was observed after 96 hours.||Subjects|||Number
838686|NCT01320137|Primary|Number of Subject Responders With Antigen Specific Th2 CD4+ T Cells Expressing Cytokines - Amended Definition|"Among cytokines expressed were IL-4, IL-5 and/or IL-13, as measured by flow cytometry and multiplex assays.
Responders to a specific cytokine were defined as subjects with concentration for that respective cytokine after Bet v 1 stimulation above P95 of the concentration for that cytokine after medium only stimulation for all subjects (Total cohort), AND at least 5 times higher than their own respective concentration after medium only stimulation."|At Day 0|The According-To-Protocol (ATP) cohort, Bet v 1 BrdU+ subjects included all subjects from the ATP cohort for which proliferation of peripheral blood mononuclear cells (PBMCs) with the birch pollen allergen Bet v 1 was observed after 96 hours.||Subjects|||Number
838687|NCT01320137|Primary|Number of Subject Responders With Antigen Specific Lymphocytes T Helper 2 (Th2) Cluster of Differentiation 4+ (CD4+) T Cells Expressing Cytokines|"Among cytokines expressed were interleukin-4 (IL-4), interleukin-5 (IL-5) and/or interleukin-13 (IL-13), as measured by flow cytometry and multiplex assays.
Responders were defined as subjects with a concentration after Bet v 1 stimulation above Percentile 95 (P95) (determined on Betula verucossa 1[Bet v 1] Bromodeoxyuridine + [BrdU+] subjects) of all concentrations after medium only stimulation"|At Day 0|The According-To-Protocol (ATP) cohort, Bet v 1 BrdU+ subjects included all subjects from the ATP cohort for which proliferation of peripheral blood mononuclear cells (PBMCs) with the birch pollen allergen Bet v 1 was observed after 96 hours.||Subjects|||Number
838688|NCT01320202|Primary|Change From Baseline Hemoglobin at End-of-Treatment: Mean Baseline and End-of-Treatment Hgb|Mean change from baseline Hgb (the average of the three most recent Hgb values preceding randomization) assessments during the last one-sixth of the treatment period for patients who prematurely withdraw from study treatment, but will include a minimum of at least the last two Hgb values. Values expressed are mean baseline and end-of-treatment Hgb, along with the mean difference (standard deviation).|Hgb measured weekly; up to 48 weeks from the date of randomization|modified intent-to-treat: all randomized patients who received at least one dose of study drug and had at least one post-dose hemoglobin measured.||grams per liter||Standard Deviation|Mean
838689|NCT01320202|Secondary|Variability of Hemoglobin Concentration: Residual Standard Deviation|The mean residual standard deviation of hemoglobin concentration value changes, as measured weekly from baseline until the end of participation in Stage 2.|Hgb measured weekly; up to 48 weeks from the date of randomization|modified intent to treat: all randomized subjects who received at least one dose of study medication and had at least one post-dose hemoglobin measured.||grams per liter||Standard Deviation|Mean
838690|NCT01320202|Secondary|Variability of Hemoglobin Concentration: Temporal Trend|The mean temporal trend of hemoglobin concentration value changes, as measured weekly from baseline until the end of participation in Stage 2.|Hgb measured weekly; up to 48 weeks from the date of randomization|modified intent to treat: all randomized subjects who received at least one dose of study medication and had at least one post-dose hemoglobin measured.||grams per liter per week||Standard Deviation|Mean
838691|NCT01320202|Secondary|Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin Saturation (TSAT)|The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin Saturation (TSAT) will be quantified.|Up to 48 weeks from the date of randomization|modified Intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin measured.||percentage of saturation||Standard Deviation|Mean
838692|NCT01320202|Secondary|Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin|The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin will be quantified.|Up to 48 weeks from the date of randomization|modified Intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin measured.||grams per liter||Standard Deviation|Mean
838693|NCT01320202|Secondary|Change From Baseline to End-of-Treatment (EoT) in Ferritin|The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Ferritin will be quantified.|Up to 48 weeks from the date of randomization|modified Intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin measured.||micrograms per liter||Standard Deviation|Mean
838694|NCT01320202|Secondary|Change From Baseline to End-of-Treatment (EoT) in Reticulocyte Hemoglobin Content (CHr)|The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Reticulocyte Hemoglobin Content (CHr) will be quantified.|Up to 48 weeks from the date of randomization|modified Intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin measured.||picograms||Standard Deviation|Mean
838695|NCT01320202|Secondary|Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Unsaturated Iron-Binding Capacity (UIBC), Serum Iron, and Total Iron-Binding Capacity (TIBC)|The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Pre-Dialysis Unsaturated Iron-Binding Capacity (UIBC), Pre-Dialysis Serum Iron, and Pre-Dialysis Total Iron-Binding Capacity (TIBC) will be quantified.|Up to 48 weeks from the date of randomization|modified Intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin measured.||micromoles per liter||Standard Deviation|Mean
840304|NCT01334957|Primary|To Determine the Safety of a Single Dose of Intravenous Ibuprofen Over 5-10 Minutes for the Reduction of Pain.|The incidence of treatment-emergent serious adverse events occurring in the six hours following administration of the first dose of intravenous ibuprofen|6 hours|||Number of Serious Adverse Events|||Number
838696|NCT01320202|Secondary|Percentage of Change From Baseline to End-of-Treatment (EoT) for: Reticulocyte Hemoglobin Content (CHr), Ferritin, and Pre-Dialysis Serum Iron Panel|A comparison of the lab values at the end-of-treatment (EoT) to baseline was performed, and the percentage of change from baseline was calculated for the following lab parameters: reticulocyte hemoglobin content (CHr), Ferritin, pre-dialysis unbound iron-binding capacity (UIBC), pre-dialysis serum iron, pre-dialysis transferrin, pre-dialysis total iron-binding capacity TIBC), and transferrin saturation (TSAT).|Up to 48 weeks from the date of randomization|modified intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin measured.||percentage of change||Standard Deviation|Mean
838697|NCT01320202|Secondary|Red Blood Cell or Whole Blood Transfusion: Number of Units Transfused|The total number of units of red blood cells or whole blood that were received by patients while in the randomized treatment stage (Stage 2). This number is the total number of units received across all randomized patients in each treatment group (it is not the average number of units received per patient). Patients remained in Stage 2 until they met protocol-defined criteria for Stage 2 completion or until they had participated in Stage 2 for 48 weeks (whichever came sooner). If a patient was transfused, they were withdrawn from Stage 2.|up to 48 weeks from the date of randomization|Intent-to-Treat (ITT): all patients randomized are included.||units of red blood cells or whole blood|||Number
838698|NCT01320202|Secondary|Red Blood Cell or Whole Blood Transfusion: Number of Patients Receiving Transfusion|The number of patients requiring red blood cell or whole blood transfusion while in the randomized treatment stage (Stage 2). Patients remained in Stage 2 until they met protocol-defined criteria for Stage 2 completion or until they had participated in Stage 2 for 48 weeks (whichever came sooner). If a patient was transfused, they were withdrawn from Stage 2.|up to 48 weeks from the date of randomization|Intent-to-Treat (ITT): all patients randomized are included.||participants|||Number
838699|NCT01320202|Secondary|Mean Change in Unsaturated Iron Binding Capacity (UIBC) From Pre- to Post-dialysis.|The mean difference between the pre-dialysis and post-dialysis unsaturated iron binding capacity (UIBC) was calculated, using all post-baseline values obtained during Stage 2. Subjects could participate in Stage 2 for up to 48 weeks, provided that they did not complete Stage 2 early due to a protocol-mandated change in anemia management or withdraw from the study entirely for other reasons.|Up to 48 weeks from the date of randomization|modified intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin measured.||micromole per liter||Standard Deviation|Mean
838700|NCT01320202|Secondary|Mean Change in TSAT (Transferrin) From Pre-dialysis to Post-dialysis.|The mean difference between the pre-dialysis and post-dialysis TSAT (transferrin) was calculated, using all post-baseline values obtained during Stage 2. Subjects could participate in Stage 2 for up to 48 weeks, provided that they did not complete Stage 2 early due to a protocol-mandated change in anemia management or withdraw from the study entirely for other reasons.|Up to 48 weeks from the date of randomization|modified intent-to treat: all randomized subjects who had at least one dose of study drug and had at least one post-dose hemoglobin measured.||percent||Standard Deviation|Mean
838701|NCT01320202|Secondary|Mean Change in Serum Iron From Pre-dialysis to Post-dialysis.|The mean difference between the pre-dialysis and post-dialysis serum iron was calculated, using all post-baseline values obtained during Stage 2. Subjects could participate in Stage 2 for up to 48 weeks, provided that they did not complete Stage 2 early due to a protocol-mandated change in anemia management or withdraw from the study entirely for other reasons.|Up to 48 weeks from the date of randomization|modified intent-to-treat population: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin measured.||micromoles per liter||Standard Deviation|Mean
838702|NCT01320202|Primary|Change From Baseline Hemoglobin at End-of-Treatment: Least-Squares Mean|Mean change from baseline Hgb (the average of the three most recent Hgb values preceding randomization) assessments during the last one-sixth of the treatment period for patients who prematurely withdraw from study treatment, but will include a minimum of at least the last two Hgb values. Value is expressed as least-squares mean with standard error.|Hgb measured weekly; up to 48 weeks from the date of randomization|modified intent-to-treat populations: all randomized subjects who received at least one dose of study medication and had at least one post-dose hemoglobin measurement obtained.||grams per liter||Standard Error|Least Squares Mean
838703|NCT01320293|Secondary|Changes in Adiponectin Profile Compared to Baseline|Adiponectin concentration in pg/ml measured at Baseline and end of treatment, 6 months.|24 weeks|17 of 18 participants completed these assessments at both time points due to one of them having an adverse event that required treatment and therefore end of treatment assessments could not be performed.||pg/ml||95% Confidence Interval|Mean
838704|NCT01320293|Secondary|Changes in IL-6 Profile Compared to Baseline|IL6 average concentration in pg/ml at Baseline compared to end of treatment, 6 months.|6 months|17 of 18 participants completed these assessments at both time points due to one of them having an adverse event that required treatment and therefore end of treatment assessments could not be performed.||pg/ml||95% Confidence Interval|Mean
838705|NCT01320293|Primary|Percentage Change in Endothelial Function Compared to Baseline.|Percentage change in endothelial function between baseline visit and end of treatment, 6 months. Endothelial function was measured by percent change in brachial artery diameter after flow mediated dilation (FMD%).|6 months|17 of 18 participants completed these assessments at both time points due to one of them having an adverse event that required treatment and therefore end of treatment assessments could not be performed.||percent change||95% Confidence Interval|Mean
838706|NCT01320553|Secondary|Ciliary Redness Evaluated by the Investigator|Ciliary redness and episcleral redness were evaluated by the investigator at 7, 15, and 20 minutes post-CAC using a 4-point (0 indicating none and 4 indicating extremely severe i.e. large, numerous, dilated blood vessels characterized by unusually severe deep red color, regardless of grade of chemosis, which involves the entire vessel bed) scale with half-unit (1-step) increments allowed.|Up to 4 weeks|||units on a scale||Standard Deviation|Mean
838707|NCT01320553|Primary|Ocular Itching|Ocular itching evaluated by the subject at 3, 5, and 7 minutes post-challenge (0-4 scale, allowing half unit increments with 0 representing none and 4 representing Incapacitating itch with an irresistible urge to rub) at Visit 5.|Up to 28 days|"Of the 122 subjects enrolled in the study, a total of 8 subjects did not complete the study: 1 in the 1334H 0.15% group, 4 in the 1334H 0.3% group, 2 in the 1334H 0.45% group and 1 in the vehicle treated group.
The Per Protocol population, comprised of all subjects who completed the study with no protocol violations, totaled 107 subjects."||units on a scale||Standard Deviation|Mean
838709|NCT01320683|Primary|Progression-free Survival|"Estimated using the product-limit method of Kaplan-Meier, and 95% confidence limits calculated for these estimates.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions."|Up to 24 months||||||
838710|NCT01320722|Secondary|Mean 24-Hour Ambulatory Blood Pressure (ABP) Nocturnal Dipping|A 24-hour mean ambulatory blood pressure was monitored using a 24 hour ABP device. The ABP device is a small box that is worn on the belt or pant/skirt line with a line that connect under the clothing to the cuff on the upper arm. Blood Pressure was recorded every 30 minutes during the day and every 60 minutes during the night for 24 hours. Nocturnal dipping is the percent change lower between the daytime and nighttime values.|Baseline and Week 8|All randomized enrolled participants with complete 24-hour ABP data available for analysis.||percent change||Standard Deviation|Mean
838711|NCT01320722|Secondary|Mean 24-Hour Ambulatory Blood Pressure (ABP)|A 24-hour mean ambulatory blood pressure was monitored using a 24 hour ABP device. The ABP device is a small box that is worn on the belt or pant/skirt line with a line that connect under the clothing to the cuff on the upper arm. Blood Pressure was recorded every 30 minutes during the day and every 60 minutes during the night for 24 hours.|Baseline and Week 8|All randomized enrolled participants with complete 24-hour ABP data available for analysis.||mmHg||Standard Deviation|Mean
838712|NCT01320722|Secondary|Change in Endothelium-Dependent Vasodilation (EDV)|Endothelial function was assessed by EDV using brachial artery ultrasonography. Measurements of brachial artery diameter were made under basal conditions and reactive hyperemia following ischaemic stimulus. A blood pressure cuff on the forearm was pumped up for 5 minutes then released. Images were taken at baseline and after reactive hyperemia (increased blood flow). The maximum diameter was determined by the investigator. Change in EDV was expressed as a percent of brachial luminal diameter calculated as post-ischaemic brachial artery diameter - pre-ischaemic brachial artery diameter/pre-ischaemic brachial artery diameter * 100.|Baseline and Week 8 (pre and post ischaemic stimulus)|All randomized enrolled participants.||percent of brachial luminal diameter||Standard Deviation|Mean
838713|NCT01320722|Primary|Angiotensin II (ATII) Concentration [Uric Acid]|ATII concentration is a measure of systemic renin angiotensin system (RAS) activation. Blood was collected and plasma ATII was analyzed using a double-antibody radioimmunoassay (RIA) laboratory test.|Week 8|All randomized enrolled participants with data available for analysis.||pg/mL||Inter-Quartile Range|Median
838714|NCT01320722|Primary|Plasma Renin Activity (PRA) [Uric Acid]|PRA is a measure of systemic renin angiotensin system (RAS) activation. Blood was collected and plasma PRA was analyzed using a competitive binding radioimmunoassay (RIA) laboratory test.|Week 8|All randomized enrolled participants with data available for analysis.||ng/mL per hour||Inter-Quartile Range|Median
838715|NCT01320722|Primary|Change in Renal Plasma Flow (RPF) Response to Captopril in High Sodium Balance [Uric Acid]|RPF in response to captopril iis a measure of the vasodilator effect from inhibiting angiotensin II (AngII)- mediated vascular tone and therefore the degree of kidney specific Renin Angiotensin System (RAS) activity. Participants consumed a high sodium diet 3 days prior to the test. Following an 8 hour fast, participants remained in a supine (lying down) position and had an intravenous (IV) catheter inserted in each arm, one for infusion and one for blood collection. An 8 milligrams (mg)/kilogram(kg) loading dose of para-aminohippuric acid (PAH) was given, immediately followed by a continuous PAH infusion at 12 mg/minute. After 60 minutes a single dose of 25 mg of captopril was administered. Three pre-captopril measurements and three post-captopril measurements of RPF were made. RPF was normalized to body surface area of 1.73 meters squared (m^2). The change in RPF was calculated as post-captopril RPF- pre-captopril RPF.|Week 8 (pre and post captopril)|All randomized enrolled participants with data available for analysis.||mL/min per 1.73 m^2||Inter-Quartile Range|Median
838716|NCT01320722|Primary|Angiotensin II (ATII) Concentration [Vitamin D]|ATII concentration is a measure of systemic renin angiotensin system (RAS) activation. Blood was collected and plasma ATII was analyzed using a double-antibody radioimmunoassay (RIA) laboratory test.|Week 8|All randomized enrolled participants included in the analysis.||pg/mL||Standard Deviation|Mean
838717|NCT01320722|Primary|Plasma Renin Activity (PRA) [Vitamin D]|PRA is a measure of systemic renin angiotensin system (RAS) activation. Blood was collected and plasma PRA was analyzed using a competitive binding radioimmunoassay (RIA) laboratory test.|Week 8|All randomized enrolled participants included in the analysis.||ng/mL per hour||Standard Deviation|Mean
838718|NCT01320722|Primary|Change in Renal Plasma Flow (RPF) in Response to Captopril in High Sodium Balance [Vitamin D]|Change in RPF in response to captopril is a measure of the vasodilator effect from inhibiting angiotensin II (AngII)- mediated vascular tone and therefore the degree of kidney specific Renin Angiotensin System (RAS) activity. Participants consumed a high sodium diet 3 days prior to the test. Following an 8 hour fast, participants remained in a supine (lying down) position and had an intravenous (IV) catheter inserted in each arm, one for infusion and one for blood collection. An 8 milligrams (mg)/kilogram(kg) loading dose of para-aminohippuric acid (PAH) was given, immediately followed by a continuous PAH infusion at 12 mg/minute. After 60 minutes a single dose of 25 mg of captopril was administered. Three pre-captopril measurements and three post-captopril measurements of RPF were made. RPF was normalized to body surface area of 1.73 meters squared (m^2). The change in RPF was calculated as post-captopril RPF- pre-captopril RPF.|Week 8 (pre and post captopril)|All randomized enrolled participants included in the analysis.||mL/min per 1.73 m^2||Standard Deviation|Mean
838719|NCT01320735|Secondary|Median Percentage of Time Off-treatment During 2 Years IAD Regimen|The total duration of leuprorelin free period was calculated as the sum of all leuprorelin free periods. The data are reported as median percentage of time off-treatment with full range.|Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit|Data are of measurements collected from participants who started IAD.||Percentage of time off-treatment||Full Range|Median
838720|NCT01320735|Primary|Number of Participants Who Switched to IAD Regimen by Visit|The data are reported as number of participants.|24 months|Data are of measurements collected from the safety analysis set, defined as all participants who signed an informed consent form and were administered at least one dose of leuprorelin.||Participants|||Number
839000|NCT01323010|Secondary|Changes in Respiratory Rate at at Discharge or Hospital Admission.|Changes in respiratory rate at discharge or hospital admission (up to 4 hours post treatment) in comparison with baseline.|at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) in comparison with baseline.|||breaths per minute||Standard Error|Mean
838721|NCT01320735|Secondary|Mean Duration of Treatment-off Time in IAD Regimen|Duration of each leuprorelin free period was calculated as (Date of first dose of leuprorelin [cycle N+1] minus last dose date [cycle N] minus 1)/30.4. If date of last dose of leuprorelin was before the date of study completion/discontinuation then the last leuprorelin free period was calculated as (Date of discontinuation/study completion minus last leuprorelin dose date)/30.4. The data are reported as mean months +/- standard deviation.|Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit|Data are of measurements collected from participants who started IAD.||Months||Standard Deviation|Mean
838722|NCT01320735|Primary|Percentage of Participants Who Discontinued From Leuprorelin Administration of IAD Regimen|The data are reported as percentage of participants.|24 months|Data are of measurements collected from the safety analysis set, defined as all participants who signed an informed consent form and were administered at least one dose of leuprorelin.||Percentage of participants|||Number
838723|NCT01320735|Other Pre-specified|Number of Participants Who Continued to Take Leuprorelin in IAD Regimen by the End of the Study|The data are reported as number of participants.|24 months|Data are of measurements collected from participants who started IAD.||Participants|||Number
838724|NCT01320735|Other Pre-specified|Number of Participants Who Received IAD Regimen During the Study|The data are reported as number of participants.|24 months|Data are of measurements collected from participants who started IAD.||Participants|||Number
838725|NCT01320735|Secondary|Median Survival Time|Time to survival was estimated as time from start of leuprorelin up to study completion/discontinuation from the study or date of death. The data are reported as median months with full range.|Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit|Participants who died while on study were used for analysis.||Months||Full Range|Median
838726|NCT01320735|Secondary|Median Time to Progression of HRPC in Participants Not Started on IAD Regimen|Time to progression of HRPC was calculated as date of progression minus date of first dose of leuprorelin. A Kaplan-Meier estimate of median time to progression to HRPC and 25% and 75% quartiles along with the 95% confidence interval for median were assessed.|Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit|Data are of measurements of participants who did not start on IAD regimen.||Months||95% Confidence Interval|Median
838727|NCT01320735|Secondary|Median Time to Progression of HRPC|Time to progression of HRPC was calculated as date of progression minus date of first dose of leuprorelin. The data are reported as median (full range).|Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit|Data are of measurements collected from the full analysis set, defined as all participants who received at least one dose of leuprorelin, signed informed consent, did not violate any inclusion/exclusion criteria and attended at least one post-baseline visit.||Months||Full Range|Median
838728|NCT01320735|Primary|Median Number of Leuprorelin Cycles|The Participants were on IAD regimen and the data are reported as number of cycles with full range.|24 months|Data are of measurements collected from the safety analysis set, defined as all participants who signed an informed consent form and were administered at least one dose of leuprorelin. However, one participant started continuous hormone therapy and was not included in the analysis.||Cycles||Full Range|Median
838729|NCT01320735|Secondary|Number of Participants Who Progressed to Hormone Refractory Prostate Cancer (HRPC)|Progression to HRPC was defined as castrate serum testosterone less than 50 ng/dL or 1.7 nmol/L plus either; biochemical progression (three consecutive rises in prostate specific antigen (PSA) levels one week apart resulting in two 50 % increases over the nadir, with PSA greater than 2 ng/ml) or radiological progression (the appearance of two or more new bone lesions on bone scan or enlargement of a soft tissue lesion using Response Evaluation Criteria in Solid Tumors (RECIST). Data are reported as number of participants with HRPC.|Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit|Data are of measurements collected from the full analysis set, defined as all participants who received at least one dose of leuprorelin, signed informed consent, did not violate any inclusion/exclusion criteria and attended at least one post-baseline visit.||Participants|||Number
838730|NCT01320735|Primary|Mean Duration of Each Leuprorelin Cycle|Duration of each cycle of leuprorelin IAD regimen was calculated as (Date of last dose of cycle of leuprorelin minus start date of cycle plus 1)/30.4. The data are reported as mean months +/- standard deviation.|24 months|Data are of measurements collected from the safety analysis set, defined as all participants who signed an informed consent form and were administered at least one dose of leuprorelin.||Months||Standard Deviation|Mean
838731|NCT01320735|Primary|Mean Duration of Leuprorelin Exposure|Total duration of leuprorelin Intermittent Androgen Deprivation (IAD) regimen was calculated as (Last dose date of Leuprorelin minus first dose date plus 1)/30.4. If the stop date of leuprorelin administration was missing then the date of last attended visit was used. Total duration may include gaps between the cycles. The data are reported as mean months +/- standard deviation.|24 months|Data are of measurements collected from the safety analysis set, defined as all participants who signed an informed consent form and were administered at least one dose of leuprorelin.||Months||Standard Deviation|Mean
838732|NCT01320735|Other Pre-specified|Duration of IAD Regimen Induction Phase|Time period between first injection of leuprorelin and stopping of treatment due to appropriate decrease of PSA as defined in the protocol. The data are reported as mean months +/- standard deviation.|At least 6-9 months after Baseline (enrollment)|Data are of measurements collected from participants who started IAD.||Months||Standard Deviation|Mean
838733|NCT01320826|Primary|Percentage of Females 50 Years and Older Undergoing First Time Colonoscopy With an Adenoma|"Percentage of patients with an adenoma = (number of patients who had at least one adenoma detected on colonoscopy / total number of colonoscopies attempted) x 100.
For this specific outcome: we explored this outcome for females 50 years and older undergoing first time colonoscopy."|[When pathology from colonoscopy available (on average 2-3 weeks after procedure)]|For this outcome, we only examined females ≥ 50 years old having their first colonoscopy||percentage of females||95% Confidence Interval|Mean
838734|NCT01320826|Secondary|Percentage of Patients Referred to a Specialist.|The percentage of patients who are anticipated to be referred to specialists, for the gastrointestinal complaint for which the colonoscopy was performed will be determined and the reason for referral will be tabulated. The referral percentage will be determined both from the time of colonoscopy (physician reported) and from the patient satisfaction phone survey (patient reported).|Within four (4) weeks of colonoscopy|||percentage of patients|||Number
838736|NCT01320826|Secondary|Patient Satisfaction With Hospital Experience for Colonoscopy|"Patient satisfaction with their hospital experience during their colonoscopy will be recorded by using a 7 point Likert scale at the time of the patient satisfaction phone survey.
7 = extremely satisfied
1 = extremely dissatisfied
Minimum score = 1 Maximum score = 7"|At patient satisfaction phone survey (on average 4 weeks after colonoscopy)|443 patients consented to and completed the post procedural satisfaction survey.||units on a scale||Inter-Quartile Range|Median
838737|NCT01320826|Secondary|Patient Satisfaction With Endoscopy Wait Time|"Patient satisfaction with endoscopy wait time will be recorded using a 7 point Likert scale at the time of the patient phone survey. 7 is extremely satisfied and 1 is extremely dissatisfied
minimum score = 1 maximum score = 7"|At patient satisfaction phone survey (on average 4 weeks after colonoscopy)|443 patients completed the post procedural satisfaction survey.||units on a scale||Inter-Quartile Range|Median
838738|NCT01320826|Secondary|Patient Comfort During Colonoscopy|"To determine the patients' comfort level during the colonoscopy, a five-item question used by the Joint Advisory Group on Gastrointestinal Endoscopy in the United Kingdom will be used.
Patient discomfort on the 5 point scale:
0 is no discomfort;
is one or two episodes of discomfort, well tolerated;
is more than two episodes of discomfort adequately tolerated;
is significant discomfort experienced several times during the procedure;
is extreme discomfort experienced frequency throughout the procedure.
Minimum value = 0, maximum value = 4 with 4 being worse."|At time of colonoscopy (DAY 1 of study)|||units on the scale||Standard Deviation|Mean
838739|NCT01320826|Secondary|Colonoscopy Withdraw Time in Cases Where no Lesions Found|Withdrawal time will be defined as the time from leaving the cecum until the colonoscope exits the anus. This will be calculated for cases in which no lesions were found.|At time of colonoscopy (DAY 1 of study)|Only examined patients in which no lesions were detected.||minutes||95% Confidence Interval|Mean
838740|NCT01320826|Secondary|Colonoscopy Complications: Bleeding, Perforation, Cardiopulmonary Complications Secondary to Conscious Sedation, and Death.|"Potential serious complications of colonoscopy include bleeding, perforation, cardiopulmonary complications secondary to conscious sedation and death.
Potential serious complications will be determined from the case report form (physician reported) and at patient satisfaction phone survey (on average four weeks after colonoscopy).
All potential serious complications of colonoscopy will be externally adjudicated."|Within four (4) weeks of colonoscopy|||patients undergoing colonoscopy|||Number
838741|NCT01320826|Primary|Percentage of Males 50 Years and Older Undergoing First Time Colonoscopy With an Adenoma|"Percentage of patients with an adenoma = (number of patients who had at least one adenoma detected on colonoscopy / total number of colonoscopies attempted) x 100.
For this specific outcome: we explored this outcome for males 50 years and older undergoing first time colonoscopy."|When pathology from colonoscopy available (on average 2-3 weeks after procedure)|We only examined this outcome for males 50 years and older having their first colonoscopy||percentage of males||95% Confidence Interval|Mean
838742|NCT01320826|Primary|Adenoma Detection Ratio|The adenoma detection ratio is the number of pathologically verified adenomas per number of colonoscopies performed. Adenoma detection ratio = total number of pathologically confirmed adenomas / number of colonoscopies attempted.|When pathology from colonoscopy available (on average 2-3 weeks after procedure)|Number of patients who underwent colonoscopy||adenomas / colonoscopy||95% Confidence Interval|Number
838743|NCT01320826|Primary|Percentage of Successful Cecal Intubations (Adjusted)|The percentage of successful cecal intubations (adjusted) = total number of colonoscopies performed where cecal intubation was achieved / (total number of colonoscopies attempted -incomplete colonoscopies due to poor bowel preparation, colonic stricture, equipment failure or severe endoscopic colitis)|At time of colonoscopy (DAY 1 of study)|||percentage of colonoscopies attempted||95% Confidence Interval|Number
838744|NCT01320826|Primary|Percentage of Successful Cecal Intubations (Crude)|The percentage of successful cecal intubations (crude) = (total # of colonoscopies performed where cecal intubation was achieved / total # of colonoscopies attempted) x 100|At time of colonoscopy (DAY 1 of study)|Prospective, observational study, all study participants were analyzed||percentage of colonoscopies performed||95% Confidence Interval|Number
838745|NCT01312428|Secondary|To Evaluate the Surgical Success of Achieving Preoperative Targets for Leg Length and Femoral Offset, or be Able to Document Changes to Pre-operative Leg Length and Offset, Using the PAL Compared to Surgeries Without Using the PAL Instrument.||6 week follow-up||||||
838746|NCT01312428|Primary|To Evaluate the Surgical Accuracy in Placing Acetabular Components at a Target of 45° Inclination and 20° Anteversion While Using the PAL Compared to Surgeries Without Using the PAL Instrument.||6 week follow-up|The study was terminated early, therefore, primary or secondary measures were not assessed.|||||
838747|NCT01312467|Secondary|Safety and Tolerability of Metformin Hydrochloride Treatment|"All participants will be evaluable for toxicity from the time of their first dose of metformin. Since toxicities in this study are measured as categorical data, primary analysis shall be by tests of binomial proportions (e.g., Mantel-Haenszel chi-squared statistic). This study will utilize the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting.
We are in the process of identifying and securing funding to complete the secondary and tertiary endpoints. Once the information is available, we will provide those results with any relevant post-hoc analyses."|Up to 16 weeks||||||
838748|NCT01312467|Secondary|Effects of Metformin Hydrochloride on Serum (Fasting and 2 Hour Postprandial Insulin and Glucose, Fasting IGF-1, IGFBP-1, IGFBP-3, Leptin, Adiponectin and Metformin Levels)|We are in the process of identifying and securing funding to complete the secondary and tertiary endpoints. Once the information is available, we will provide those results with any relevant post-hoc analyses.|Up to 16 weeks||||||
838749|NCT01312467|Secondary|Effects of Metformin Hydrochloride on Colorectal Mucosa Proliferation (Ki-67, Phosphorylated IGF-1 Receptor, Phosphorylated Insulin Receptor, Phosphorylated AKT, Phosphorylated mTOR, and Phosphorylated AMP Kinase)|We are in the process of identifying and securing funding to complete the secondary and tertiary endpoints. Once the information is available, we will provide those results with any relevant post-hoc analyses.|Up to 16 weeks||||||
838772|NCT01312844|Secondary|The Mean Levels of Physiological Measures of ECT (Heart Rate)|Heart rate was taken immediately post ECT administration at each ECT visit. We averaged heart rate for each participant at each ECT administration. The reported mean refers to the average among all participants in each group.|Duration of ECT treatment (usually 2 weeks)|Missing vitals forms for one participant in Scopolamine group (n=4), only reported data for 3 participants in Scopolamine group||Beats per minute||Standard Deviation|Mean
838750|NCT01312467|Primary|Change in Activated S6serine235 (i.e., the Ratio of pS6serine235/S6serine235)|Tissue S6Ser235 immunostaining was analyzed by the study pathologist using Histo Score (HScore) analysis at baseline and post- metformin (Week 12). The Hscore is determined by estimation of the percentage of cells positively stained with mild, moderate, or strong staining intensity. The final score is determined by weighted estimate, as follows: Hscore = (# cell stained with High intensity/total # cells)x3 + (# cells stained with median intensity/total # cells)x2 + (# cells stained with low intensity/total # cells)x1. Mean and standard deviation of the change in the histo score (H score) of pS6serine235 from baseline were calcuated.|From baseline to 12 weeks|The analysis is based on 32 participants who have evaluable data.||weighted ratio of staining cells||Standard Deviation|Mean
838751|NCT01312519|Secondary|Time Necessary to Perform the Bone Marrow Procedure|The time necessary to perform the procedure was measured as follows: Time started once the needle and skin came into contact and time stopped once the sample was collected and the needle was removed from the patient.|Day 1 needle insertion through needle removal|Per protocol, 50 patients were enrolled in the study and randomized to the manual bone marrow sampling device or the battery powered device.||seconds||Standard Deviation|Mean
838752|NCT01312519|Primary|Subject Reported Level of Pain During Procedure|Subjects were asked to rate the level of pain they experienced during the procedure for needle insertion, following penetration of the cortex. A 0 to 10 pain scale was used where 0=no pain and 10= worst possible pain.|Day 1 during the needle insertion|as per protocol, 50 patients were enrolled in the study and randomized to the manual bone marrow sampling device or the battery powered device.||units on a scale||Standard Deviation|Mean
838753|NCT01312766|Secondary|Live Birth Rate||9 months after treatment|||percentage of participants|||Number
838754|NCT01312766|Secondary|Number of Cleaved Embryos||two days after insemination|||embryos||Standard Deviation|Mean
838755|NCT01312766|Secondary|Total Number of Inseminated Oocytes (IVF and ICSI)|number of oocytes that were inseminated via IVF or injected via ICSI technique.|on the day of oocyte retrieval|||oocytes||Standard Deviation|Mean
838756|NCT01312766|Secondary|Ratio Mature/Total Number of Oocytes Retrieved.|Percentage of retrieved oocytes considered to be mature.|at the end of the stimulation.|||percentage of total oocytes retrieved|||Number
838757|NCT01312766|Secondary|Number of Mature (Grade III Metaphase II) Oocytes Retrieved.||at the end of the stimulation.|||oocytes||Standard Deviation|Mean
838758|NCT01312766|Secondary|Clinical Pregnancy Rate,|defined as a pregnancy showing ultrasound embryonic heart activity at 10 – 11 weeks after embryo transfer;|10 – 11 weeks after embryo transfer|||percentage of participants|||Number
838759|NCT01312766|Secondary|Implantation Rate|defined as the mean of the total number of implanted embryos (presence of gestational sac assessed by ultrasound) divided by the total number of transferred embryos x 100;|10-11 weeks after embryo transfer|||percentage of embryos transferred||Standard Deviation|Mean
838760|NCT01312766|Secondary|17-β Estradiol (E2) Serum Concentration on the Monitoring Day Before hCG Injection;||up to 23 days after treatment start|||pg/ml||Standard Deviation|Mean
838761|NCT01312766|Secondary|Controlled Ovarian Stimulation Duration (Days)||up to 23 days after treatment start|||days||Standard Deviation|Mean
838762|NCT01312766|Secondary|Positive b-hCG Test||up to 5 weeks after treatment start|||percentage of participants|||Number
838763|NCT01312766|Secondary|Embryo Quality (Percentage of Patients With at Least One Top Quality Embryo)|Assessed by counting the total number of embryos obtained, the number of embryos transferred, frozen and discarded.|up to 28 days after treatment start|The population analysed corresponds to the patients who had at least one embryo to be analysed (i.e 120 participants in the hMG-IBSA group and 123 in the Menopur group). Of this, 119 in the hMG-IBSA group and 121 in the Menopur group underwent embryo transfer.||percentage of participants|||Number
838764|NCT01312766|Secondary|Mean hMG Dose (Total);||up to 22 days after treatment start|||Internationa Units (IU)||Standard Deviation|Mean
838765|NCT01312766|Primary|Total Number of Oocytes Retrieved||up to 24 days after treatment start|||number of oocytes||Standard Deviation|Mean
838766|NCT01312805|Primary|Diagnosis Rate of Asthma||one year|We excluded those participants who had a previous diagnosis of asthma in the 14 months before the start of the study. This left the numbers seen above.||Participants|||Count of Participants
838767|NCT01312818|Secondary|Number of Subjects With Activated Caspases and Other Regulators of Apoptosis|Activation of caspases and other regulators of apoptosis in treated blast cells will be determined by Western analysis (correlative lab analysis).|From Day 1 to 30 Days After Last Dose|The trial was terminated early with only 2 patients so caspase samples were not sent for analysis.|||||
838768|NCT01312818|Secondary|Number of Subjects Experiencing Drug Related Adverse Events|To characterize the toxicities of bortezomib, vorinostat and dexamethasone when used in combination. Toxicity will be graded using the NCI’s Common Terminology Criteria for Adverse Events (CTCAE 4.0).|Day 1 of Treatment to 30 Days Post Treatment|||participants|||Number
838769|NCT01312818|Primary|Number of Subjects Who Achieved Complete Remission of Their Disease|Complete Remission (CR): A CR requires that the following be recorded concurrently: an absolute neutrophil count (segs and bands) > 1000/μL, no circulating blasts, platelets > 100,000/μL; adequate bone marrow cellularity with trilineage hematopoiesis, and < 5% marrow leukemia blast cells. All previous extramedullary manifestations of disease must be absent. If patients continue on with treatment, there can be no evidence of recurrence of ALL for at least 4 weeks.|Day 30|||participants|||Number
838770|NCT01312844|Secondary|The Mean Levels of Physiological Measures of ECT (Energy Needed)|Mean energy needed to induce the seizure for each participant at each ECT administration they received. The reported mean refers to the average among all participants in each group.|Duration of ECT treatment (usually 2 weeks)|Missing ECT forms for one participant in Scopolamine group (n=4), only reported data for 3 participants in Scopolamine group||joules||Standard Deviation|Mean
838771|NCT01312844|Secondary|The Mean Levels of Physiological Measures of ECT (Seizure Duration)|Mean duration in seconds of the seizure induced by ECT for each participant at each ECT administration they received.The reported mean refers to the average among all participants in each group.|Duration of ECT treatment (usually 2 weeks)|Missing ECT forms for one participant in Scopolamine group (n=4), only reported data for 3 participants in Scopolamine group||seconds||Standard Deviation|Mean
838802|NCT01313182|Secondary|Measure Rate of Staphylococcus Aureus Resistance to Mupirocin.|Lab will culture isolates when time and money permit|Isolates collected and frozen||||||
838773|NCT01312844|Secondary|The Mean Levels of Physiological Measures of ECT (Blood Pressure)|Blood pressure was taken immediately post ECT administration at each ECT visit. We averaged Blood pressure for each participant at each ECT administration. The reported mean refers to the average among all participants in each group.|Duration of ECT treatment (usually 2 weeks)|Missing vitals forms for one participant in Scopolamine group (n=4), only reported data for 3 participants in Scopolamine group||mmHg||Standard Deviation|Mean
838774|NCT01312844|Secondary|The Mean Number of Moderate to Severe Side Effects|The mean number of adverse events classified as moderate to severe.|Duration of ECT treatment (usually 2 weeks)|||number of side effects||Standard Deviation|Mean
838775|NCT01312844|Secondary|Number of ECT Treatments Withheld Due to Cognitive Impairment|The number of ECT treatments withheld during the course of the study due to cognitive impairment. In these cases, the participant would still be enrolled in the study but have a reduced # of ECTs. This outcome measure does not include patients who withdrew from the study.|Duration of ECT treatment (usually 2 weeks)|||ECT Treatments withheld||Standard Deviation|Mean
838776|NCT01312844|Primary|Number of ECT Treatments Received to Achieve Response/Remission|The number of ECT treatments needed to achieve response (defined as a HAM D score less than half of baseline) and remission (defined as a HAM D score of less than 8). If patients HAM D score rose above these markers at any point in the study, they were not considered as responding or remitting.The HAM D 17 measures severity of depression with 52 being most severe and 0 being no depression.|Duration of ECTtreatment (usually 2 weeks)|Only 3 (out of 4) Scopolamine patients and 2 (out of 3) placebo patients reached response and remission.||# of ECT administrations||Standard Deviation|Mean
838777|NCT01312844|Primary|Time to Response for Patients Receiving ECT|The number of days between baseline HAM D score and HAM D score showing response (defined as a HAM D score less than half of baseline). If patients HAM D score rose above this marker at any point in the study, they were not considered as responding.The HAM D 17 measures severity of depression with 52 being most severe and 0 being no depression. .|Duration of ECT treatment (usually 2 weeks)|Only 3 (out of 4) Scopolamine patients and 2 (out of 3) placebo patients reached response||days||Standard Deviation|Mean
838778|NCT01312844|Primary|Change in Ham D 17 Scores|Change in Ham D 17 scores measured by the difference between baseline HAM D score and HAM D score at last ECT administration. The HAM D 17 measures severity of depression with 52 being most severe and 0 being no depression. A negative change score refers to a decrease in HAM D score, while a positive change score would refer to an increase in HAM D score.|At the time of ECT completion (about 2 weeks)|||units on a scale||Standard Deviation|Mean
838779|NCT01312948|Secondary|Equivalence of Apnea-hypopnea Index (AHI) on the New Pixi Mask Compared With the Child's Usual Mask|Apnea-Hypopnea index (AHI) is a measure of the severity of sleep disordered breathing (SDB). It describes how many events of compromised breathing occur each hour of sleep. The higher the AHI, the more severe the SDB (mild 5-15, moderate 15-30, severe >30). In clinical practice an AHI <5 demonstrates efficacy of treatment. AHI was recorded during a monitored sleep study on the new Pixi mask, and compared with the AHI from a monitored sleep study on the child's usual mask. The outcome hypothesis was that the Pixi mask AHI would be equivalent or reduced compared to the patients usual mask|>4 hours monitored sleep study|Analysis was as per protocol||apnea hypopnoea index||Standard Deviation|Mean
838780|NCT01312948|Primary|Usability Ratings of the Pixi Paediatric Mask Compared With the Child's Current Mask|"Before trialling the Pixi mask, parents rated the usability of their child's usual mask using a 0-10 Likert Scale where 0 = poor and 10 = excellent. After trialling the Pixi mask, parents then completed the same questionnarie for the Pixi mask.
Usability was defined as a single overall score of mask performance. Parents considered mask seal, comfort, stability and red marks when scoring each mask for usability."|8 nights use|Analysis was as per protocol||units on a scale||Standard Deviation|Mean
838781|NCT01312961|Secondary|Change From Baseline in Number of Inhalations Per Day of Albuterol or Levalbuterol to Week 12|Number of Albuterol or Levalbuterol inhalations were recorded daily by the participants in their electronic diary as Albuterol or Levalbuterol was to be used only as needed for symptoms, not on a regular basis or prophylactically.|Baseline, Week 12|mITT population. Number of participants analyzed = participants with at least one post-baseline assessment.||number of inhalations/day||Standard Deviation|Mean
838782|NCT01312961|Secondary|Change From Baseline in Number of Nocturnal Awakenings Per Day to Week 12|Participants recorded every morning on awakening the number of asthma-related nocturnal awakenings requiring use of rescue medication that occurred during the previous night.|Baseline, Week 12|mITT population. Number of participants analyzed = participants with at least one post-baseline assessment.||number of awakenings/day||Standard Deviation|Mean
838783|NCT01312961|Secondary|Change From Baseline in Evening Asthma Symptom Scores to Week 12|PM (post meridiem) symptom scoring system rates were participant’s overall asthma symptoms experienced during the day. It ranges from 0 to 4 as: 0=very well, no asthma symptoms, 1=one episode of wheezing, cough, or breathlessness, 2=more than one episode of wheezing, cough, or breathlessness without interference of normal activities, 3=wheezing, cough, or breathlessness most of the day, which interfered to some extent with normal activities, 4=asthma very bad, unable to carry out daily activities as usual.|Baseline, Week 12|mITT population. Number of participants analyzed = participants with at least one post-baseline assessment.||units on a scale||Standard Deviation|Mean
838784|NCT01312961|Secondary|Change From Baseline in Morning Asthma Symptom Scores to Week 12|AM (ante meridiem) symptom scoring system rates were participant’s overall asthma symptoms experienced during the night. It ranges from 0 to 4 as: 0 = No asthma symptoms, slept through the night, 1= Slept well, but some complaints in the morning. No nighttime awakenings,2= Woke up once because of asthma (including early awakening),3= Woke up several times because of asthma (including early awakening), 4= Bad night, awake most of the night because of asthma.|Baseline, Week 12|mITT population. Number of participants analyzed = participants with at least one post-baseline assessment.||units on a scale||Standard Deviation|Mean
838785|NCT01312961|Secondary|Change From Baseline in 22-item Sinonasal Outcome Test (SNOT-22) Score to Week 12|The SNOT-22 is a validated measure of health related quality of life in sinonasal disease. It is a 22 item questionnaire with each item assigned a score ranging from 0-5. The total score may range from 0 (no disease) -110 (worst disease), lower scores represent better health related quality of life.|Baseline, Week 12|mITT population. Number of participants analyzed = participants with at least one post-baseline assessment.||units on a scale||Standard Deviation|Mean
838803|NCT01313182|Secondary|Measure Adverse Events Related to Mupirocin and Povidone-iodine.|Patients were given an adverse event log to complete after treatment|At time of treatment||||||
838786|NCT01312961|Secondary|Change From Baseline in Asthma Control Questionnaire (5-question Version [ACQ-5]) to Week 12|ACQ-5 questionnaire is a validated questionnaire comprising of 5 questions for asthma symptoms: woken at night by symptoms, wake in the mornings with symptoms, limitation of daily activities, shortness of breath, and wheeze. Participants were asked to rate their asthma symptoms during the previous week on a 7-point scale as 0=no impairment, 6=maximum impairment. ACQ-5 score is the mean of the 5 questions and range between 0 (disease totally controlled) and 6 (disease severely uncontrolled), a higher score indicated lower asthma control.|Baseline, Week 12|mITT population. Number of participants analyzed = participants with at least one post-baseline assessment.||units on a scale||Standard Deviation|Mean
838787|NCT01312961|Secondary|Change From Baseline in Peak Expiratory Flow (PEF) to Week 12|The PEF is a participant’s maximum speed of expiration, as measured with a peak flow meter. Peak flow testing for PEF was performed at home (morning and evening) while sitting or standing prior to using any medication (if needed) for asthma.|Baseline, Week 12|mITT population. Number analyzed = participants with at least one post-baseline assessment for each category.||liters/minute||Standard Deviation|Mean
838788|NCT01312961|Secondary|Change From Baseline in Forced Expiratory Flow in One Second (FEV1) to Week 12|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.|Baseline, Week 12|mITT population. Number of participants analyzed = participants with at least one post-baseline assessment.||Liters||Standard Deviation|Mean
838789|NCT01312961|Secondary|Percentage of Participants With Composite Asthma Events|Composite asthma event was defined as a 30% or greater reduction from baseline in morning PEF on 2 consecutive days together with 6 or more additional reliever puffs of albuterol or levalbuterol in a 24-hour period (compared to baseline) on 2 consecutive days.|Baseline up to Week 12|mITT population.||percentage of participants|||Number
838790|NCT01312961|Secondary|Time to First Asthma Exacerbation: Kaplan-Meier Estimates at Week 4, Week 8 and Week 12|The time-to-asthma exacerbation was defined as the time from the date of randomization to the date of the first asthma exacerbation event; for participants without asthma exacerbation, it was censored at the end of treatment visit date. The median time to first asthma exacerbation was not estimated because the number of asthma exacerbations was too low in the Dupilumab arm. Therefore, alternative Kaplan-Meier statistics, the probability of asthma exacerbation at Week 4, 8 and 12, are presented as the descriptive measure statistics.|Baseline up to Week 12|mITT population.||Probability of asthma exacerbation||95% Confidence Interval|Number
838791|NCT01312961|Primary|Percentage of Participants With Asthma Exacerbation|An asthma exacerbation was defined as the occurrence of any of the following: ≥30% reduction from baseline in morning PEF on 2 consecutive days; or ≥6 additional reliever puffs of albuterol or levalbuterol in a 24-hour period (compared to baseline) on 2 consecutive days; or deterioration of asthma, as determined by the investigator, requiring systemic steroid treatment, or an increase in inhaled corticosteroid (ICS) of ≥4 times the last dose received prior to discontinuation from the study, or hospitalization. The occurrence of asthma exacerbations by individual criteria are reported.|Baseline up to Week 12|Modified intent-to-treat (mITT) population that included all randomized participants who received at least one dose of study drug. Participants were analysed in the treatment group to which they were randomized.||percentage of participants|||Number
838792|NCT01313039|Secondary|In Vitro Tamoxifen Response in Tumors|To assess for in vitro tamoxifen response in tumors following therapy with AZD6244.|2 years||||||
838793|NCT01313039|Secondary|Rate of ER Promoter Methylation in ER-negative/Low Breast Cancer|To determine the rate of ER promoter methylation in ER-negative/low breast cancer tumors that do not attain an ER response following AZD6244 therapy.|2 years||||||
838794|NCT01313039|Secondary|Changes in ER-regulated Gene Expression in E-negative/Low Breast Cancer|To assess for changes in ER-regulated gene expression in ER-negative/low breast tumors following AZD6244 therapy through assessment of protein expression by immunhistochemistry in paraffin embedded tissues.|2 Years||||||
838795|NCT01313039|Primary|Increase of ER Protein Expression in ER-Negative/Low Breast Cancer|"To evaluate in a clinical neoadjuvant model whether MEK inhibitor AZD6244 can increase ER protein expression in ER-negative/low breast cancer, as measured by the ER response rate by both standard immunohistochemistry and Allred Score."|2 years|Only 1 subject had evaluable study data||participants|||Number
838796|NCT01313078|Primary|Evaluation of Safety in Patients With Ovarian, Fallopian Tube, and/or Primary Peritoneal Cancer.|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|11 months, 25 days|||Participants|||Number
838797|NCT01313078|Primary|6 Month Progression Free Survival|Proportion of patients able to attain a 6 month progression free survival. Progressive disease is defined as >20% increase in the sum of the longest diameter of all target lesions, or the unequivocal increase in size of non-measurable lesions agreed upon by two investigators, or the appearance of new lesions.|6 months|||Participants|||Number
838798|NCT01313117|Secondary|Total Neuropathy Score (TNS)|The Total Neuropathy score (TNS) is a validated score that combines signs, symptoms, and very limited nerve conduction studies (NCS). It was designed to assess peripheral nerve function and has been used as an endpoint in clinical trials of toxic neuropathy. The TNS is a composite scale with a range of values from 0 (normal) to 28 (severely affected). It includes data from 7 different categories. Patients are asked to assess the severity of sensory symptoms on a scale of 0 (no symptoms) to 4 (symptoms above knees or elbows, or functionally disabling). Next, 4 examination categories are assessed. These include pin sensation, vibration sensation, deep tendon reflexes, and strength. Signs are scored from 0 to 4 depending on severity. The nerve conduction portion of the scale consists of measurements of a motor (peroneal) and sensory (sural) nerve. Motor and sensory responses are graded on a scale of 0 to 4 depending on the severity of an abnormality.|4 months|Failure to reach the MTD precluded our ability to perform any meaningful analysis of the TNS.|||||
838799|NCT01313117|Secondary|Cumulative Rate of Adverse Events||4 months|||participants|||Number
838800|NCT01313117|Secondary|Proportion of Patients Who Complete the Proposed Regimen of Daily ALA||4 months|||participants|||Number
838801|NCT01313117|Primary|Identification of the Optimal Dose of ALA Based on Acceptable Adverse Event(AE) Profile|Based on acceptable adverse event (AE) profile and continual reassessment method dose escalation.|4 months|Although our dose finding analysis suggested a maximum tolerated dose of 500mg daily, it should be noted that we failed to fully complete the Continual Reassessment Method (CRM) dose finding portion of the study. As such, we can not make confident dose finding statements on the basis of this trial.||mg|||Number
838806|NCT01313208|Secondary|Medical Outcomes Study (MOS) Sleep Problems Index II at Each Time Point|The MOS-Sleep comprises 12 items and measures key sleep structures across 6 domains. These domains are Sleep Disturbance (4 items), Sleep Adequacy (2 items), Sleep Quantity (1 item), Daytime Somnolence (3 items), Snoring (1 item), and Awakening short of breath or with a headache, (1 item). The scale also produces two indices. Index-II uses 9 items from four domains including Sleep Disturbance (4 items), Sleep Adequacy (2 items), Shortness of Breath (1 item), and Daytime Somnolence (2 items). In MOS Sleep norm-based scoring, all scales are scored on the same metric, where 50 is the mean for the general U.S. population and 10 is the standard deviation. Higher scores indicate more severe sleep problems. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants included in the analyses at each time point."||scores on a scale||Standard Error|Least Squares Mean
838807|NCT01313208|Secondary|Medical Outcomes Study (MOS) Sleep Problems Index I at Each Time Point|The MOS-Sleep comprises 12 items and measures key sleep structures across 6 domains. These domains are Sleep Disturbance (4 items), Sleep Adequacy (2 items), Sleep Quantity (1 item), Daytime Somnolence (3 items), Snoring (1 item), and Awakening short of breath or with a headache, (1 item). The scale also produces two indices. The Sleep Problems Index-I is drawn from 6 items in the four domains including Sleep Disturbance (2 items), Sleep Adequacy (2 items), Shortness of Breath (1 item), and Daytime Somnolence (1 item). In MOS Sleep norm-based scoring, all scales are scored on the same metric, where 50 is the mean for the general U.S. population and 10 is the standard deviation. Higher scores indicate more severe sleep problems. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants included in the analyses at each time point."||scores on a scale||Standard Error|Least Squares Mean
838808|NCT01313208|Secondary|Medical Outcomes Study (MOS) Sleep Daytime Somnolence Scale at Each Time Point|The MOS-Sleep comprises 12 items and measures key sleep structures across 6 domains. These domains are Sleep Disturbance (4 items), Sleep Adequacy (2 items), Sleep Quantity (1 item), Daytime Somnolence (3 items), Snoring (1 item), and Awakening short of breath or with a headache, (1 item). Daytime somnolence measures drowsiness or sleepiness during the day. In MOS Sleep norm-based scoring, all scales are scored on the same metric, where 50 is the mean for the general U.S. population and 10 is the standard deviation. Higher scores indicate more severe sleep problems. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants included in the analyses at each time point."||scores on a scale||Standard Error|Least Squares Mean
838809|NCT01313208|Secondary|Medical Outcomes Study (MOS) Sleep Adequacy Scale at Each Time Point|The MOS-Sleep comprises 12 items and measures key sleep structures across 6 domains. These domains are Sleep Disturbance (4 items), Sleep Adequacy (2 items), Sleep Quantity (1 item), Daytime Somnolence (3 items), Snoring (1 item), and Awakening short of breath or with a headache, (1 item). Sleep Adequacy measures sleep sufficiency in terms of whether the participant sleeps enough to provide restoration of wakefulness. In MOS Sleep norm-based scoring, all scales are scored on the same metric, where 50 is the mean for the general U.S. population and 10 is the standard deviation. For sleep adequacy a higher score indicates better sleep quality. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants included in the analyses at each time point."||scores on a scale||Standard Error|Least Squares Mean
838810|NCT01313208|Secondary|Medical Outcomes Study (MOS) Sleep Snoring Scale at Each Time Point|The MOS-Sleep comprises 12 items and measures key sleep structures across 6 domains. These domains are Sleep Disturbance (4 items), Sleep Adequacy (2 items), Sleep Quantity (1 item), Daytime Somnolence (3 items), Snoring (1 item), and Shortness of Breath (1 item). In MOS Sleep norm-based scoring, all scales are scored on the same metric, where 50 is the mean for the general U.S. population and 10 is the standard deviation. Higher scores indicate more severe sleep problems. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants included in the analyses at each time point."||scores on a scale||Standard Error|Least Squares Mean
838811|NCT01313208|Secondary|Medical Outcomes Study (MOS) Sleep Shortness of Breath or Headache Scale at Each Time Point|The MOS-Sleep comprises 12 items and measures key sleep structures across 6 domains. These domains are Sleep Disturbance (4 items), Sleep Adequacy (2 items), Sleep Quantity (1 item), Daytime Somnolence (3 items), Snoring (1 item), and Awakening short of breath or with a headache, (1 item). In MOS Sleep norm-based scoring, all scales are scored on the same metric, where 50 is the mean for the general U.S. population and 10 is the standard deviation. Higher scores indicate more severe sleep problems. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants included in the analyses at each time point."||scores on a scale||Standard Error|Least Squares Mean
838812|NCT01313208|Secondary|Medical Outcomes Study (MOS) Sleep Disturbance Scale at Each Time Point|The MOS-Sleep comprises 12 items and measures key sleep structures across 6 domains. These domains are Sleep Disturbance (4 items), Sleep Adequacy (2 items), Sleep Quantity (1 item), Daytime Somnolence (3 items), Snoring (1 item), and Shortness of Breath (1 item). Sleep Disturbance measures the ability to fall asleep and to maintain restful sleep. In MOS Sleep norm-based scoring, all scales are scored on the same metric, where 50 is the mean for the general U.S. population and 10 is the standard deviation. Higher scores indicate more severe sleep problems. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants included in the analyses at each time point."||scores on a scale||Standard Error|Least Squares Mean
838813|NCT01313208|Secondary|Participant Assessment of Fatigue at Each Time Point|The participant's assessment of fatigue was collected using a single-item 100 mm visual analogue scale. The participant was asked to draw a vertical line through a horizontal line to indicate the degree of fatigue they experienced because of their condition over the past week. The horizontal line is 100 mm in length with ‘0’ and ‘no fatigue’ on the left end of the line and ‘100’ and ‘extreme fatigue’ on the right end of the line. Least squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants included in the analyses at each time point."||scores on a scale||Standard Error|Least Squares Mean
838814|NCT01313208|Secondary|Work Productivity and Activity Impairment Questionnaire (WPAI): Percent Overall Work Impairment at Each Time Point|This self-administered questionnaire is designed to address impairment to the work productivity and activity of participants due to rheumatoid arthritis in the past 7 days. Percent overall work impairment takes into account both hours missed due to rheumatoid arthritis symptoms and the participant’s assessment of the degree to which rheumatoid arthritis affected their productivity while working. A higher percentage indicates greater impairment and less productivity. Least squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants employed and included in the analyses at each time point."||percent overall work impairment||Standard Error|Least Squares Mean
838815|NCT01313208|Secondary|Work Productivity and Activity Impairment Questionnaire (WPAI): Percent Activity Impairment at Each Time Point|This self-administered questionnaire is designed to address impairment to the work productivity and activity of participants due to rheumatoid arthritis. Percent activity impairment is derived from the patient’s assessment of the degree to which rheumatoid arthritis affected their regular daily activities. A higher percentage indicates greater impairment and less productivity. Least squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants included in the analyses at each time point."||percent activity impairment||Standard Error|Least Squares Mean
838816|NCT01313208|Secondary|Work Productivity and Activity Impairment Questionnaire (WPAI): Percent Impairment While Working (Presenteeism) at Each Time Point|This self-administered questionnaire is designed to address impairment to the work productivity and activity of participants due to rheumatoid arthritis in the past 7 days. Percent impairment while working was derived from the participant’s assessment of the degree to which rheumatoid arthritis affected their productivity while working. A higher percentage indicates greater impairment and less productivity. Least squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants employed and included in the analyses at each time point."||percent impairment while working||Standard Error|Least Squares Mean
838817|NCT01313208|Secondary|Work Productivity and Activity Impairment Questionnaire (WPAI): Percent Work Time Missed (Absenteeism) at Each Time Point|This self-administered questionnaire is designed to address impairment to the work productivity and activity of participants due to rheumatoid arthritis in the past 7 days. Percent of work time missed is derived from the number of hours of work missed due to rheumatoid arthritis symptoms as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed. Least squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants employed and included in the analyses at each time point."||percent work time missed||Standard Error|Least Squares Mean
838818|NCT01313208|Secondary|Short Form 36 Health Survey (SF-36) Mental Health Domain Score at Each Time Point|The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better quality of life. The mental health sub-score assesses general mental health (psychological distress and well-being). Least squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants included in the analyses at each time point."||scores on a scale||Standard Error|Least Squares Mean
838819|NCT01313208|Secondary|Short Form 36 Health Survey (SF-36) Role-Emotional Domain Score at Each Time Point|The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better quality of life. The role-emotional subscale assesses limitations in usual role activities because of emotional problems. Least squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants included in the analyses at each time point."||scores on a scale||Standard Error|Least Squares Mean
838829|NCT01313208|Secondary|Patient's Global Assessment of Disease Activity at Each Time Point|The participant’s global assessment of their arthritis disease activity was assessed by the participant circling a number from 0 to 10 on a horizontal Likert scale ranging from “No Activity at All” (score = 0) to “Worst Activity Imaginable” (score = 10).|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants included in the analyses at each time point."||scores on a scale||Standard Deviation|Mean
838820|NCT01313208|Secondary|Short Form 36 Health Survey (SF-36) Social Functioning Domain Score at Each Time Point|The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning. The social functioning subscale assesses limitations in social activities because of physical or emotional problems. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants included in the analyses at each time point."||scores on a scale||Standard Error|Least Squares Mean
838821|NCT01313208|Secondary|Short Form 36 Health Survey (SF-36) General Health Perceptions Domain Score at Each Time Point|The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better quality of life. Least squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants included in the analyses at each time point."||scores on a scale||Standard Error|Least Squares Mean
838822|NCT01313208|Secondary|Short Form 36 Health Survey (SF-36) Bodily Pain Domain Score at Each Time Point|The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning (less pain). Least squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants included in the analyses at each time point."||scores on a scale||Standard Error|Least Squares Mean
838823|NCT01313208|Secondary|Short Form 36 Health Survey (SF-36) Role-Physical Domain Score at Each Time Point|The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning. The role-physical subscale assesses limitations in usual role activities because of physical health problems. Least squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants included in the analyses at each time point."||scores on a scale||Standard Error|Least Squares Mean
838824|NCT01313208|Secondary|Short Form 36 Health Survey (SF-36) Vitality Domain Score at Each Time Point|The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning. The vitality sub-score assesses energy and fatigue. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants included in the analyses at each time point."||scores on a scale||Standard Error|Least Squares Mean
838825|NCT01313208|Secondary|Short Form 36 Health Survey (SF-36) Physical Functioning Domain Score at Each Time Point|The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning. The physical functioning subscale assesses limitations in physical activities because of health problems. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants included in the analyses at each time point."||scores on a scale||Standard Error|Least Squares Mean
838826|NCT01313208|Secondary|C-reactive Protein Levels at Each Time Point|C-Reactive Protein (CRP) was measured from blood samples by a central laboratory as a marker for inflammation.|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants included in the analyses at each time point."||mg/L||Standard Deviation|Mean
838827|NCT01313208|Secondary|Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ-DI) at Each Time Point|The HAQ-DI asks about the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores). Responses in each functional area are scored from 0 indicating no difficulty to 3 indicating inability to perform a task in that area. The overall score is the average of each of the 8 category scores and ranges from 0 to 3, where zero represents no disability and three very severe, high-dependency disability.|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; N indicates the number of participants included in the analyses at each time point."||scores on a scale||Standard Deviation|Mean
838828|NCT01313208|Secondary|Physician Global Assessment of Disease Activity at Each Time Point|The global assessment of the participant’s arthritis was assessed by the physician circling a number from 0 to 10 on a horizontal Likert scale ranging from “No Activity at All” (score = 0) to “Worst Activity Imaginable” (score = 10).|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants included in the analyses at each time point."||scores on a scale||Standard Deviation|Mean
838830|NCT01313208|Secondary|Patient Global Assessment of Joint Pain at Each Time Point|"The severity of the participant’s joint pain was assessed using a visual analog scale (VAS). The participant was asked to draw a mark through a 100 mm horizontal line to indicate how much pain they were experiencing “today, from ‘0’ (no pain at all) on the left end of the line to 100 (worst pain imaginable) on the right end of the line."|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants included in the analyses at each time point."||scores on a scale||Standard Deviation|Mean
838831|NCT01313208|Secondary|Swollen 28-Joint Count (SJC28) at Each Time Point|Twenty-eight joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination.|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants included in the analyses at each time point."||swollen joints||Standard Deviation|Mean
838832|NCT01313208|Secondary|Tender 28-Joint Count (TJC28) at Each Time Point|Twenty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination.|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants included in the analyses at each time point."||tender joints||Standard Deviation|Mean
838833|NCT01313208|Secondary|Simplified Clinical Disease Activity Index (SDAI) Score at Each Time Point|"The simplified disease activity index (SDAI) is a composite measure that sums the total number of:
28 tender joint counts,
28 swollen joint counts,
Patient's Global Assessment of Disease Activity measured on a Likert scale from 0 to 10, where 0 = lowest disease activity and 10 = highest;
Physician's Global Assessment of Disease Activity measured on a Likert scale from 0 to 10, where 0 = lowest disease activity and 10 = highest, and
C-reactive protein (CRP) in mg/dL.
The SDAI score ranges from 0 to approximately 86 where lower scores indicate less disease activity."|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants included in the analyses at each time point."||scores on a scale||Standard Deviation|Mean
838834|NCT01313208|Secondary|Percentage of Participants Achieving SDAI Low Disease Activity at Each Time Point|The simplified disease activity index (SDAI) is a composite measure that sums the total number of: - 28 tender joint counts, - 28 swollen joint counts, - Patient's Global Assessment of Disease Activity measured on a Likert scale from 0 to 10 where 0 = lowest disease activity and 10 = highest; - Physician's Global Assessment of Disease Activity measured on a Likert scale from 0 to 10 where 0 = lowest disease activity and 10 = highest, and - C-reactive protein (CRP) in mg/dL. The SDAI score ranges from 0 to approximately 86 where lower scores indicate less disease activity. SDAI low disease activity is defined as a score ≤ 11.|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants included in the analyses at each time point."||percentage of participants|||Number
838835|NCT01313208|Secondary|Percentage of Participants Achieving SDAI Remission at Each Time Point|"The simplified disease activity index (SDAI) is a composite measure that sums the total number of:
28 tender joint counts,
28 swollen joint counts,
Patient's Global Assessment of Disease Activity measured on a Likert scale from 0 to 10 where 0= lowest disease activity and 10 = highest;
Physician's Global Assessment of Disease Activity measured on a Likert scale from 0 to 10, where 0 = lowest disease activity and 10 = highest, and
C-reactive protein (CRP) in mg/dL.
The SDAI score ranges from 0 to approximately 86 where lower scores indicate less disease activity. SDAI remission is defined as a score ≤ 3.3."|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants included in the analyses at each time point."||percentage of participants|||Number
838836|NCT01313208|Secondary|Clinical Disease Activity Index (CDAI) Score at Each Time Point|"The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:
28 tender joint count (TJC),
28 swollen joint count (SJC),
Patient's Global Assessment of Disease Activity measured on a Likert scale from 0 to 10 where 0 = lowest disease activity and 10 = highest;
Physician's Global Assessment of Disease Activity (measured on a Likert scale from 0 to 10 where 0 = lowest disease activity and 10 = highest).
The CDAI score ranges from 0 to 76 where lower scores indicate less disease activity."|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants included in the analyses at each time point."||scores on a scale||Standard Deviation|Mean
838837|NCT01313208|Secondary|Percentage of Participants Achieving CDAI Low Disease Activity at Each Time Point|"The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:
28 tender joint count (TJC),
28 swollen joint count (SJC),
Patient's Global Assessment of Disease Activity measured on a Likert scale form 0 to 10, where 0 = lowest disease activity and 10 = highest;
Physician's Global Assessment of Disease Activity -measured on a Likert scale from 0 to 10, where 0 = lowest disease activity and 10 = highest. The CDAI score ranges from 0 to 76 where lower scores indicate less disease activity. CDAI low disease activity is defined as a score ≤ 10."|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants included in the analyses at each time point."||percentage of participants|||Number
838838|NCT01313208|Secondary|Percentage of Participants Achieving CDAI Remission at Each Time Point|"The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:
28 tender joint count (TJC),
28 swollen joint count (SJC),
Patient's Global Assessment of Disease Activity measured on a likert scale from 0 to 10, where 0 = lowest disease activity and 10 = highest;
Physician's Global Assessment of Disease Activity measured on a Likert scale from 0 to 10, where 0 = lowest disease activity and 10 = highest.
The CDAI score ranges from 0-76 where lower scores indicate less disease activity. CDAI remission is defined as a score ≤ 2.8."|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants included in the analyses at each time point."||percentage of participants|||Number
838839|NCT01313208|Secondary|Percentage of Participants Achieving Count Remission at Each Time Point|"Count remission is achieved when a participant satisfies all of the following at any given time point: - 68 tender joint count ≤ 1, - 66 swollen joint count ≤ 1, - C-reactive protein (CRP) (in mg/dL) ≤1, and - patient global assessment of disease activity ≤ 1 (measured on a likert scale from 0 to 10 ranging from no activity at all to worst activity imaginable)."|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants included in the analyses at each time point."||percentage of participants|||Number
838840|NCT01313208|Secondary|Percentage of Participants With RAPID3 Remission or Low Severity at Each Time Point|"The Multi-Dimensional Health Assessment Questionnaire (MDHAQ) is adapted from the standard HAQ and is used for the computation of the Routine Assessment of Patient Index Data 3 (RAPID3). The RAPID 3 includes the 3 Core Data Set measures of physical function, pain, and patient global estimate. The score for physical function ranges from 0 to 10 and is calculated by adding the ten activities of daily living, each scored from 0 to 3 by the patient (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do) and dividing the total raw score by 3. Pain and global estimate of health are measured on a likert scale from 0 to 10, both scored 0 (best) to 10 (worst). The three 0-10 scores for physical function, pain, and global assesment of health are added together for a composite score of 0 to 30. The RAPID3 composite score includes 4 categories: High Severity > 12, Moderate Severity = 6.1 - 12, Low severity = 3.1 - 6, and Remission ≤ 3."|Baseline and Weeks 4, 12, and 24|"Primary analysis set; LOCF was used. N indicates the number of participants included in the analyses at each time point."||percentage of participants|||Number
838841|NCT01313208|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 70 Response at Each Timepoint|"A participant was a responder if the following 3 criteria for improvement from Baseline were met:
≥ 70% improvement in tender joint count;
≥ 70% improvement in swollen joint count; and
≥ 70% improvement in at least 3 of the 5 following parameters:
Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
Patient's global assessment of disease activity (measured on a likert scale from 0 to 10);
Physician's global assessment of disease activity (measured on a likert scale from 0 to 10);
Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);
C-reactive protein (CRP) level."|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants with available data at each time point."||percentage of participants|||Number
838842|NCT01313208|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Each Timepoint|"A participant was a responder if the following 3 criteria for improvement from Baseline were met:
≥ 50% improvement in tender joint count;
≥ 50% improvement in swollen joint count; and
≥ 50% improvement in at least 3 of the 5 following parameters:
Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
Patient's global assessment of disease activity (measured on a likert scale from 0 to 10);
Physician's global assessment of disease activity (measured on a likert scale from 0 to 10);
Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);
C-reactive protein (CRP) level."|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants with available data at each time point."||percentage of participants|||Number
838843|NCT01313208|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Each Timepoint|A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in tender joint count; • ≥ 20% improvement in swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a likert scale from 0 to 10); ◦ Physician's global assessment of disease activity (measured on a likert scale from 0 to 10); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); ◦ C-Reactive Protein level.|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants with available data at each time point."||percentage of participants|||Number
838844|NCT01313208|Secondary|Percentage of Participants Achieving DAS28 Remission at All Other Timepoints|"Remission is defined by a DAS28 score less than 2.6. The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables:
The number of swollen and tender joints assessed using the 28-joint count;
C-reactive protein (CRP)
Patient's global assessment of disease activity measured on a likert scale from 0 (no activity at all) to 10 (worst activity).
The DAS28 score ranges from zero to ten. A DAS28 above 5.1 indicates high disease activity."|Baseline and Weeks 2, 4, 8, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants included in the analyses at each time point."||percentage of participants|||Number
838845|NCT01313208|Secondary|Percentage of Participants Achieving DAS28 Low Disease Activity at All Other Timepoints|"Low disease activity is defined by a disease activity score (28 joint) calculated using the C-reactive protein formula (DAS28-CRP) of less than 3.2. The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables:
The number of swollen and tender joints assessed using the 28-joint count;
C-Reactive Protein (CRP) level
Patient's global assessment of disease activity measured on a likert scale from 0 (no activity at all) to 10 (worst activity).
The DAS28 score ranges from zero up to approximately ten. DAS28 scores above 5.1 indicate high disease activity."|Baseline and Weeks 2, 4, 8, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants included in the analysis at each time point."||percentage of participants|||Number
838846|NCT01313208|Secondary|Percentage of Participants Achieving DAS28 Remission at Week 12|"Remission is defined by a DAS28 score less than 2.6. The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables:
The number of swollen and tender joints assessed using the 28-joint count;
C-reactive protein (CRP)
Patient's global assessment of disease activity measured on a likert scale from 0 (no activity at all) to 10 (worst activity).
The DAS28 score ranges from zero to ten. DAS28 above 5.1 indicates high disease activity."|Week 12|Primary analysis set; LOCF was used||percentage of participants|||Number
838847|NCT01313208|Primary|Percentage of Participants Achieving DAS28 Low Disease Activity at Week 12|"Low disease activity is defined by a disease activity score (28 joint) calculated using the C-reactive protein formula (DAS28-CRP) of less than 3.2. The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables: • The number of swollen and tender joints assessed using the 28-joint count; • C-Reactive Protein (CRP) level • Patient's global assessment of disease activity measured on a likert scale from 0 (no activity at all) to 10 (worst activity).
The DAS28 score ranges from zero up to approximately ten. DAS28 scores above 5.1 indicate high disease activity."|Week 12|Primary analysis set (all randomized participants); last observation carried forward (LOCF) imputation was used.||percentage of participants|||Number
838848|NCT01313221|Secondary|Number of Participants With Adverse Events|An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant. A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria: • fatal, • life threatening, • requires in-patient hospitalization or prolongation of existing hospitalization, • results in persistent or significant disability/incapacity, • congenital anomaly/birth defect, and/or • other significant medical hazard.|32 weeks|Safety analysis was based on treatment received, regardless of group assignment. 177 patients are included in group A, including 144 patients randomized to group A, 23 patients who were non-randomized and 10 patients randomized to group B but never received topical agents; Group B includes 133 patients who received etanercept plus ≥1 topical agent.||participants|||Number
838849|NCT01313221|Secondary|Health Resource Utilization: Ability to Perform Daily Activities|Participants were asked: How much did your psoriasis affect your ability to do your daily activities or household chores? Possible answers were: a) A great deal; b) Quite a bit; c) Somewhat; d) Minimally; e) Not at all.|Baseline and 24 weeks|Full Analysis Set; LOCF was used.||participants|||Number
838850|NCT01313221|Secondary|Health Resource Utilization: Number of Participants With Missed Hours From Work|Participants who were employed answered the following question regarding the past 4 weeks: How many hours per week did you miss from work because of your psoriasis? The number of participants with one or more missed hours of work per week is reported.|Baseline and 24 weeks|Full Analysis Set who were employed and with available data; LOCF was used.||participants|||Number
838851|NCT01313221|Secondary|Health Resource Utilization: Productivity While Working|Participants who were employed were asked: How much did your psoriasis affect your productivity while you were working? Possible responses were: a) A great deal; b) Quite a bit; c) Somewhat; d) Minimally; e) Not at all.|Baseline and 24 weeks|Full Analysis Set who were employed and with available data at each time point; LOCF was used. For the Etanercept 50 mg BIW group there were 106 and 100 participants with available data at Baseline and Week 24 respectively. For the Etanercept + Topical group there were 93 and 85 participants respectively.||participants|||Number
838852|NCT01313221|Secondary|Health Resource Utilization: Employment Status|Participants completed a questionnaire to assess their health resource utilization (HRU) related to psoriasis. Participants were asked their employment status at Baseline and at Week 24.|Baseline and 24 weeks|Full Analysis Set; LOCF was used.||participants|||Number
838853|NCT01313221|Secondary|Health Resource Utilization: Out of Pocket Expenses|Participants completed a questionnaire to assess their health resource utilization (HRU) related to psoriasis. To assess out of pocket expenses, participants answered the following question regarding the past 4 weeks: Not counting study mandated visits, what out-of-pocket expenses did you spend for the management of psoriasis (i.e. costs due to travelling to doctor appointment, hospital or clinic parking costs, alternative medications)?|Baseline and 24 weeks|Full Analysis Set with available data; LOCF was used.||Canadian dollars||Inter-Quartile Range|Median
838854|NCT01313221|Secondary|Health Resource Utilization: Number of Participants Who Needed Friend or Family Care|Participants completed a questionnaire to assess their health resource utilization (HRU) related to psoriasis. Participants answered the following question regarding the past 4 weeks: How many hours have you had a friend or family member take time off work to provide care or transportation? The number of participants who had paid or non-paid help for one or more hours is reported.|Baseline and 24 weeks|Full Analysis Set with available data; LOCF was used.||participants|||Number
838855|NCT01313221|Secondary|Health Resource Utilization: Number of Participants Requiring Paid Help With Chores|Participants completed a questionnaire to assess their health resource utilization (HRU) related to psoriasis. To assess the number of participants who needed paid help with chores, participants answered the following question regarding the past 4 weeks: How many times have you paid someone to help you do chores around the house (cleaning, maintenance, lawn care)? The number of participants who paid for help one or more times is reported.|Baseline and 24 weeks|Full Analysis Set with available data; LOCF was used.||participants|||Number
838856|NCT01313221|Secondary|Health Resource Utilization: Number of Participants With Home Healthcare Visits|Participants completed a questionnaire to assess their health resource utilization (HRU) related to psoriasis. To assess the number of homecare visits, participants answered the following question regarding the past 4 weeks: How many times have you received care from a health professional in your home? The number of participants with one or more visits is reported.|Baseline and 24 weeks|Full Analysis Set with available data; LOCF was used.||participants|||Number
838857|NCT01313221|Secondary|Health Resource Utilization: Number of Participants With Visits to a Healthcare Provider|Participants completed a questionnaire to assess their health resource utilization (HRU) related to psoriasis. To assess the number of visits to a healthcare provider, participants answered the following questions regarding the past 4 weeks: How many times have you been to any physician’s office or urgent care clinic? How many times have you seen a nurse practitioner, a physician assistant, a psychologist, a naturopath, an acupuncturist, a chiropractor, or other healthcare professional (HCP)? The number of participants with one or more visits is reported.|Baseline and 24 weeks|Full Analysis Set with available data; LOCF was used.||participants|||Number
838858|NCT01313221|Secondary|Change in Treatment Satisfaction Questionnaire for Medications (TSQM) Scores From Baseline to Weeks 12 and 24|The TSQM is a validated questionnaire consisting of 14 questions regarding a participant's perception of the level of satisfaction or dissatisfaction with the medication they are taking. Four scales are generated: side effects, effectiveness, convenience, and global satisfaction. Optional responses are: Extremely Dissatisfied, Very Dissatisfied, Dissatisfied, Somewhat Satisfied, Satisfied, Very Satisfied, and Extremely Satisfied. From the responses, a scale score from 0 - 100 is calculated, with a higher score indicating greater satisfaction. Change was calculated as postbaseline value - Baseline value so that a positive change indicates improvement.|Baseline and Weeks 12 and 24|Full analysis set; LOCF was used; n indicates the number of patients with available data for each scale at each time point.||units on a scale||Standard Deviation|Mean
838910|NCT01313312|Primary|Mean Change From Baseline to End of Study/Early Withdrawal in White Blood Cell (WBC) Count, Neutrophils, Lymphocytes and Platelets|Blood samples for WBC count with differentials (neutrophils, lymphocytes) and platelet count were taken at baseline, at post treatment follow up visit Week 4, and at end of study or early withdrawal.|Up to Week 52|Subjects who entered the study and received at least one open label injection of Dysport® were evaluated for safety analysis. Only subjects with data available for analysis at the point of testing are reported.||Giga cells/L||Full Range|Mean
838859|NCT01313221|Secondary|Change in Treatment Satisfaction Questionnaire for Medications (TSQM) Scores From Week 12 to Week 24|TSQM is a validated questionnaire consisting of 14 questions regarding a participant's perception of the level of satisfaction or dissatisfaction with the medication they are taking. Four scales are generated: side effects, effectiveness, convenience, and global satisfaction. Optional responses are: Extremely Dissatisfied, Very Dissatisfied, Dissatisfied, Somewhat Satisfied, Satisfied, Very Satisfied, and Extremely Satisfied. From the responses, a scale score from 0 - 100 is calculated, with a higher score indicating greater satisfaction. Change was calculated as Week 24 - Week 12 so that a positive change indicates improvement over time. Change was adjusted for treatment using a mixed model.|Week 12 and Week 24|Efficacy Evaluable with available data; n indicates the number of patients with available data for each scale.||units on a scale||Standard Error|Least Squares Mean
838860|NCT01313221|Secondary|Change From Baseline to Weeks 12 and 24 in Dermatology Quality of Life Index (DQLI) Total Score|The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. Change from Baseline was calculated as Baseline value - postbaseline value so that a positive change indicates improvement.|Baseline and Week 12 and Week 24|Full analysis set with available data; LOCF was used||units on a scale||Standard Deviation|Mean
838861|NCT01313221|Secondary|Change From Week 12 to Week 24 in Dermatology Quality of Life Index (DQLI) Total Score|The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. Change from Week 12 to Week 24 is calculated as: Week 12 value - Week 24 value so that a positive change indicates improvement. Change was adjusted for treatment using a mixed model.|Week 12 and Week 24|Efficacy Evaluable set with available data||units on a scale||Standard Error|Least Squares Mean
838862|NCT01313221|Secondary|Percent Change in the Percentage of Body Surface Area (BSA) Involvement From Baseline to Weeks 12, 16, 20, and 24|"The percentage of body surface area involved with psoriasis was measured by the same blinded assessor performing the PASI assessments.
Change from Baseline \ is presented as a percentage of the Baseline value: Baseline value - postbaseline value / Baseline value * 100, so that a positive change indicates improvement."|Baseline and Weeks 12, 16, 20, and 24|Full analysis set with available data; LOCF was used||percent change||Standard Deviation|Mean
838863|NCT01313221|Secondary|Percent Change in the Percentage of Body Surface Area (BSA) Involvement From Week 12 to Weeks 16, 20, and 24|"The percentage of body surface area involved with psoriasis was measured by the same blinded assessor performing the PASI assessments. Change from Week 12 is presented as a percentage of the Week 12 value: Week 12 value - postbaseline value / Week 12 value * 100, so that a positive change indicates improvement.
Change was adjusted for treatment using a mixed model."|Weeks 12, 16, 20, and 24|Efficacy analysis set with available data||percent change||Standard Error|Least Squares Mean
838864|NCT01313221|Secondary|Percentage of Participants With a Static Physician’s Global Assessment (sPGA) of Psoriasis Score of 0 (Clear) or 1 (Almost Clear)|The sPGA scale is completed by the same blinded assessor performing the PASI assessments and is designed to evaluate the physician’s global assessment of the participant’s psoriasis based on severity of induration, scaling, and erythema. The sPGA is assessed on a scale of 0 to 5 (0 = clear, 5 = severe).|Weeks 12, 16, 20, and 24|Full Analysis Set, LOCF was used.||percentage of participants||95% Confidence Interval|Number
838865|NCT01313221|Secondary|Percentage of Participants With a PASI 90 Response|The percentage of participants with a 90% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI score is based on an assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and the percent area affected as observed on the day of examination. The score ranges from 0 (best outcome) to 72 (worst outcome).|Baseline and Weeks 12, 16, 20 and 24|Full analysis set with a non-missing response; LOCF was used.||percentage of participants||95% Confidence Interval|Number
838866|NCT01313221|Secondary|Percentage of Participants With a PASI 75 Response|The percentage of participants with a 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI score is based on an assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and the percent area affected as observed on the day of examination. The score ranges from 0 (best outcome) to 72 (worst outcome).|Baseline and Weeks 12, 16, 20 and 24|Full analysis set with a non-missing response; LOCF was used.||percentage of participants||95% Confidence Interval|Number
838867|NCT01313221|Secondary|Percentage of Participants With a PASI 50 Response|The percentage of participants with a 50% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI score is based on an assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and the percent area affected as observed on the day of examination. The score ranges from 0 (best outcome) to 72 (worst outcome).|Baseline and Weeks 12, 16, 20 and 24|Full analysis set with a non-missing response; LOCF was used.||percentage of participants||95% Confidence Interval|Number
838868|NCT01313221|Secondary|Percent Change in PASI From Baseline to Weeks 12, 16, 20, and 24|The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Change from Baseline is presented as a percentage of the Baseline value: Baseline value - postbaseline value / Baseline value * 100, so that a positive change indicates improvement.|Baseline and Weeks 12, 16, 20, and 24|Full analysis set, (all enrolled participants who had taken at least 1 dose of study treatment and had at least 1 post-baseline efficacy evaluation) and with available data. Last Observation Carried Forward (LOCF) imputation was used.||percent change||Standard Deviation|Mean
838869|NCT01313221|Secondary|Percent Change in PASI From Week 12 to Weeks 16 and 20|The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Change from Week 12 presented as a percentage of the Week 12 value: Week 12 value - postbaseline value / Week 12 value * 100, so that a positive change indicates improvement. Change was adjusted for treatment using a mixed model.|Week 12, Week 16 and Week 20|Efficacy Evaluable set with available data at each time point (indicated by n)||percent change||Standard Error|Least Squares Mean
838870|NCT01313221|Primary|Percent Change in Psoriasis Area and Severity Index (PASI) From Week 12 to Week 24|The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Change from Week 12 to Week 24 is presented as a percentage of the Week 12 value: Week 12 value - Week 24 value / Week 12 value * 100 so that a positive change indicates improvement. Change was adjusted for treatment using a mixed model.|Week 12 and Week 24|Efficacy Evaluable set, which included all randomized participants who had taken at least 1 dose of study drug and had at least 1 post-randomization efficacy evaluation, and with available data at Week 12 and Week 24.||percent change||Standard Error|Least Squares Mean
838871|NCT01313273|Secondary|Reduction in Chromogranin A Serum Levels||Baseline, Week 96|Study early terminated due to poor enrollment|||||
838872|NCT01313273|Secondary|Median Time to PSA Response||Week 96|Study early terminated due to poor enrollment|||||
838873|NCT01313273|Secondary|Prostate Specific Antigen (PSA) Response||Week 96|Study early terminated due to poor enrollment|||||
838874|NCT01313273|Primary|Progression-free Survival||Week 96|Study early terminated due to poor enrollment.|||||
838875|NCT01313299|Primary|Change From Baseline in MAS Score in the Primary Targeted Muscle Group (PTMG)|MAS scale is used to assess muscle tone using a 6-point scale where: 0=No increase in muscle tone, 1=Slight increase in muscle tone manifested by a catch and release or by minimal resistance at the end of the range of motion (ROM) when the part is flexed or extended, 1±Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the ROM, 2=Marked increase in muscle tone through most of the ROM but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part(s) rigid in flexion or extension. The MAS has been derived for analyses as follows: 0=0 ; 1=1; 1+=2; 2=3; 3=4 and 4=5.|From Baseline (Day 1) to Week 4|Intention to treat (ITT) population included all randomized subjects who received at least one injection of study drug and had a MAS score at baseline (pretreatment) and at week 4. Total 5 subjects were excluded from ITT population as they did not have MAS score at baseline or/and at week 4.||units on a scale||Standard Deviation|Mean
838876|NCT01313299|Secondary|Change From Baseline in DAS Score for the Principal Target of Treatment (PTT)|"DAS is a 4-point scale used to determine the extent of functional impairment in 4 functional domains (dressing, hygiene, limb position and pain). DAS scale rating: 0=No disability, 1=Mild disability (noticeable but does not interfere significantly with normal activities), 2=Moderate disability (normal activities require increased effort and/or assistance) and 3=Severe disability (normal activities limited).
If subject chose 'Hygiene' as PTT the score collected will be between 0 and 3."|From Baseline (Day 1) to Week 4|ITT population. Two subjects each from Placebo and Dysport 1000 U had missed DAS assessment at baseline and week 4.||units on a scale||Standard Deviation|Mean
838877|NCT01313299|Secondary|Physician's Global Assessment (PGA) of Treatment Response|PGA is a 9-point scale used to assess global overall treatment response by the investigator (-4: markedly worse, -3: much worse, -2: worse, -1: slightly worse, 0: no change, +1: slightly improved, +2: improved, +3: much improved and +4: markedly improved).|At Week 4|ITT population. Two subjects each from Placebo and Dysport 1000 U had missed PGA assessment at week 4||units on a scale||Standard Deviation|Mean
838878|NCT01313312|Secondary|Mean Change From Baseline in European 5 Dimensions, 5 Level (EQ-5D-5L) QoL at End of Study/Early Withdrawal Visit|Subjects were asked to complete the EQ-5D-5L QoL questionnaires prior to the study treatment at baseline and at the end of study/early withdrawal visit. The EQ-5D-5L index is a generic preference based measure of health related QoL producing utility scores that represent subject preferences for particular health states. This instrument rated subject health state looking at 5 specific dimensions such as mobility, self-care, usual activity, pain/discomfort and anxiety/depression and scored their general health state. Each dimension has 5 levels of severity (no problems, slight problems,moderate problems, severe problems and extreme problems). In addition, a visual analogue scale (VAS) ranging from 0 to 100 was also included for the patients to summarize their overall health status, where 0 is the worst and 100 the best possible health state. The mean values for each dimension and the VAS scores at baseline and at the end of-study /early withdrawal are reported.|Up to Week 52|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.||units on a scale||Standard Deviation|Mean
838891|NCT01313312|Secondary|Percentage of Subjects With at Least One Grade Reduction in DAS for Individual Domains at Week 4|The DAS is a 4-point scale. The extent of functional impairment in 4 functional domains (dressing, hygiene, limb position and pain) was rated as follows: 0=no disability, 1=mild disability (noticeable but does not interfere significantly with normal activities), 2=moderate disability (normal activities require increased effort and/or assistance) and 3=severe disability (normal activities limited). The percentage of subjects with at least one grade reduction in DAS for each of the individual domains at Week 4 is reported.|At Week 4|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.||percentage of subjects|||Number
838879|NCT01313312|Secondary|Mean Change From Baseline in Short Form (36) Health Survey (SF-36) Quality of Life (QoL) at End of Study/Early Withdrawal Visit|Subjects were asked to complete the SF-36 questionnaires prior to the study treatment at baseline and at the end of study/early withdrawal visit. The SF-36 is a generic non-preference based health status measure. This instrument assessed subject health across 8 variable dimensions, which are specific health domains such as physical functioning, social functioning and vitality. Each variable item score is coded and turned into a 0–100 scale where 0 indicates the worst and 100 indicates the best possible health state for both the Physical Component Summary (PCS) and Mental Component Summary (MCS) of the questionnaire. Baseline results and the change from baseline to end of study/early withdrawal for the PCS and MCS are reported.|Up to Week 52|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.||units on a scale||Standard Deviation|Mean
838880|NCT01313312|Secondary|Mean Change From Baseline in Modified Frenchay Scale (MFS) at Week 4|The MFS was used to measure upper limb active function. Each subject was video taped while performing specific tasks. The videos were sent to a central provider and were read and scored by two independent readers blinded to the timing of the video and to treatment. These central assessments were used for the analysis of efficacy endpoints. The MFS consists of 10 tasks asking the subject to reach, grasp, carry and release different objects of different sizes which subjects are likely to use in their daily life. Each of these tasks was rated on a 10 point scale ranging from no movement to normal movement; for each task, the score 5 is used to rate a task barely accomplished. Mean change in MFS from baseline to Week 4 was reported.|At Week 4|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.||units on a scale||Standard Deviation|Mean
838881|NCT01313312|Secondary|Mean Change From Baseline at Week 4 in Ease of Applying a Splint|The ease of applying a splint was evaluated on a 6-point scale (0= no splint needed, –1= splint needed and applied with no difficulty, –2= splint needed and applied with mild difficulty, –3= splint needed and applied with moderate difficulty, –4= splint needed and applied with severe difficulty, –5= splint needed,but unable to apply). Mean change in ease of applying a splint from baseline to Week 4 was reported.|At Week 4|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.||units on a scale||Standard Deviation|Mean
838882|NCT01313312|Secondary|Mean Change From Baseline in Active Range of Motion (AROM) at Week 4 in the 3 Possible PTMGs|The AROM was assessed by the range of extension achieved by the subject moving each joint in the PTMGs (extrinsic finger flexors, elbow flexors and wrist flexors) without assistance. A goniometer was used for measurements in the elbow and wrist flexors but not for measurements in the extrinsic finger flexors. Mean changes in AROM in the 3 possible PTMGs from baseline to Week 4 are reported.|At Week 4|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.||units on a scale||Standard Deviation|Mean
838883|NCT01313312|Secondary|Mean Change From Baseline to Week 4 for Spasticity Grade (Y) in Shoulder Extensors|The TS was used to measure spasticity in shoulder extensors. The TS is administered by applying passive stretch to a muscle group. The spasticity grade (Y) assesses quality of muscle reaction on a 5-point scale (measured at fast speed): 0 =No resistance throughout passive movement, 1=slight resistance throughout passive movement, 2=clear catch at precise angle, interrupting passive movement, followed by release, 3=fatigable clonus (less than 10 seconds when maintaining pressure) occurring at a precise angle, followed by release. 4=unfatigable clonus (more than 10 seconds when maintaining pressure) occurring at precise angle. Mean changes in spasticity grade (Y) from baseline to Week 4 are reported.|At Week 4|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.||units on a scale||Standard Deviation|Mean
838884|NCT01313312|Secondary|Mean Change From Baseline to Week 4 for Angle of Arrest (XV1), Angle of Catch (XV3) and Angle of Spasticity (X) in Shoulder Extensors|The TS was used to measure spasticity in shoulder extensors. The TS is administered by applying passive stretch to a muscle group at two velocities. Slow speed of muscle stretch measures the range of passive motion. During a slow stretching movement, the examiner determines the angle of movement arrest, either due to subject discomfort or a mechanical resistance. The same movement is repeated at high velocity (as fast as possible) to determine the angle of catch and release. The angle of movement arrest at slow velocity (XV1) and the angle of catch at fast speed (XV3) were recorded. The spasticity angle (X) was calculated as the difference between XV1 and XV3. Mean changes in Angles XV1, XV3 and X from baseline to Week 4 are reported.|At Week 4|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.||Degrees||Standard Deviation|Mean
838900|NCT01313312|Secondary|Percentage of Subjects With at Least 1 or 2 Grade Reduction in MAS for Extrinsic Finger Flexors at Week 4|The MAS consists of 6 grades: 0, 1, 1+, 2, 3, or 4 that can be applied to muscles of both the upper and lower limbs. The MAS was applied by the rater by stretching the joint through its full available range over 1 second. The percentage of subjects with at least a 1 grade reduction and at least a 2 grades reduction from baseline in mean MAS in the extrinsic finger flexors at Week 4 are reported.|At Week 4|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.||percentage of subjects|||Number
838885|NCT01313312|Secondary|Mean Change From Baseline to Week 4 for Spasticity Grade (Y) in Wrist Flexors as PTMG|The TS was used to measure spasticity in wrist flexors. The TS is administered by applying passive stretch to a muscle group. The spasticity grade (Y) assesses quality of muscle reaction on a 5-point scale (measured at fast speed): 0 =No resistance throughout passive movement, 1=slight resistance throughout passive movement, 2=clear catch at precise angle, interrupting passive movement, followed by release, 3=fatigable clonus (less than 10 seconds when maintaining pressure) occurring at a precise angle, followed by release. 4=unfatigable clonus (more than 10 seconds when maintaining pressure) occurring at precise angle. Mean changes in spasticity grade (Y) from baseline to Week 4 are reported.|At Week 4|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.||units on a scale||Standard Deviation|Mean
838886|NCT01313312|Secondary|Mean Change From Baseline to Week 4 for Angle of Arrest (XV1), Angle of Catch (XV3) and Angle of Spasticity (X) in Wrist Flexors as PTMG|The TS was used to measure spasticity in wrist flexors. The TS is administered by applying passive stretch to a muscle group at two velocities. Slow speed of muscle stretch measures the range of passive motion. During a slow stretching movement, the examiner determines the angle of movement arrest, either due to subject discomfort or a mechanical resistance. The same movement is repeated at high velocity (as fast as possible) to determine the angle of catch and release. The angle of movement arrest at slow velocity (XV1) and the angle of catch at fast speed (XV3) were recorded. The spasticity angle (X) was calculated as the difference between XV1 and XV3. Mean changes in Angles XV1, XV3 and X from baseline to Week 4 are reported.|At Week 4|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.||Degrees||Standard Deviation|Mean
838887|NCT01313312|Secondary|Mean Change From Baseline to Week 4 for Spasticity Grade (Y) in Elbow Flexors as PTMG|The TS was used to measure spasticity in elbow flexors.The TS is administered by applying passive stretch to a muscle group. The spasticity grade (Y) assesses quality of muscle reaction on a 5-point scale (measured at fast speed): 0 =No resistance throughout passive movement, 1=slight resistance throughout passive movement, 2=clear catch at precise angle, interrupting passive movement, followed by release, 3=fatigable clonus (less than 10 seconds when maintaining pressure) occurring at a precise angle, followed by release. 4=unfatigable clonus (more than 10 seconds when maintaining pressure) occurring at precise angle. Mean changes in spasticity grade (Y) from baseline to Week 4 are reported.|At Week 4|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.||units on a scale||Standard Deviation|Mean
838888|NCT01313312|Secondary|Mean Change From Baseline to Week 4 for Angle of Arrest (XV1), Angle of Catch (XV3) and Angle of Spasticity (X) in Elbow Flexors as PTMG|The TS was used to measure spasticity in elbow flexors. The TS is administered by applying passive stretch to a muscle group at two velocities. Slow speed of muscle stretch measures the range of passive motion. During a slow stretching movement, the examiner determines the angle of movement arrest, either due to subject discomfort or a mechanical resistance. The same movement is repeated at high velocity (as fast as possible) to determine the angle of catch and release. The angle of movement arrest at slow velocity (XV1) and the angle of catch at fast speed (XV3) were recorded. The spasticity angle (X) was calculated as the difference between XV1 and XV3. Mean changes in Angles XV1, XV3 and X from baseline to Week 4 are reported.|At Week 4|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.||Degrees||Standard Deviation|Mean
838889|NCT01313312|Secondary|Mean Change From Baseline to Week 4 for Spasticity Grade (Y) in Extrinsic Finger Flexors as PTMG|The TS was used to measure spasticity in extrinsic finger flexors. The TS is administered by applying passive stretch to a muscle group. The spasticity grade (Y) assesses quality of muscle reaction on a 5-point scale (measured at fast speed): 0 =No resistance throughout passive movement, 1=slight resistance throughout passive movement, 2=clear catch at precise angle, interrupting passive movement, followed by release, 3=fatigable clonus (less than 10 seconds when maintaining pressure) occurring at a precise angle, followed by release. 4=unfatigable clonus (more than 10 seconds when maintaining pressure) occurring at precise angle. Mean changes in spasticity grade (Y) from baseline to Week 4 are reported.|At Week 4|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.||units on a scale||Standard Deviation|Mean
838890|NCT01313312|Secondary|Mean Change From Baseline to Week 4 for Angle of Arrest (XV1), Angle of Catch (XV3) and Angle of Spasticity (X) in Extrinsic Finger Flexors as PTMG|The Tardieu Scale (TS) was used to measure spasticity in extrinsic finger flexors. The TS is administered by applying passive stretch to a muscle group at two velocities. Slow speed of muscle stretch measures the range of passive motion. During a slow stretching movement, the examiner determines the angle of movement arrest, either due to subject discomfort or a mechanical resistance. The same movement is repeated at high velocity (as fast as possible) to determine the angle of catch and release. The angle of movement arrest at slow velocity (XV1) and the angle of catch at fast speed (XV3) were recorded. The spasticity angle (X) was calculated as the difference between XV1 and XV3. Mean changes in Angles XV1, XV3 and X from baseline to Week 4 are reported.|At Week 4|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.||Degrees||Standard Deviation|Mean
840907|NCT01338636|Primary|Change From Baseline in Peak Exercise Pulmonary Vascular Resistance (PVR)|PVR is the resistance offered by the pulmonary circulatory system.|Baseline to Week 24|The analysis population included evaluable participants who completed the 24-week treatment period.||Woods units (WU)||Standard Deviation|Mean
838892|NCT01313312|Secondary|Percentage of Subjects With at Least 1 Grade Reduction in DAS for PTT at Week 4|At baseline the subject and investigator together selected one of the four DAS domains as the PTT. The selected domain was required to have a rating of moderate or severe (≥2) at baseline. The DAS is a 4-point scale, the extent of functional impairment in 4 functional domains (dressing, hygiene, limb position and pain) was rated as follows: 0=no disability, 1=mild disability (noticeable but does not interfere significantly with normal activities), 2=moderate disability (normal activities require increased effort and/or assistance) and 3=severe disability (normal activities limited). The percentage of subjects with at least 1 grade reduction from baseline in DAS for PTT at Week 4 are reported.|At Week 4|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.||Percentage of Subjects|||Number
838893|NCT01313312|Secondary|Mean Change From Baseline in Disability Assessment Scale (DAS) Score for the Principal Target of Treatment (PTT) at Week 4|At baseline the subject and investigator together selected one of the four DAS domains as the PTT. The selected domain was required to have a rating of moderate or severe (≥2) at baseline. The DAS is a 4-point scale, the extent of functional impairment in 4 functional domains (dressing, hygiene, limb position and pain) was rated as follows: 0=no disability, 1=mild disability (noticeable but does not interfere significantly with normal activities), 2=moderate disability (normal activities require increased effort and/or assistance) and 3=severe disability (normal activities limited). The mean changes in DAS at Week 4 are reported.|At Week 4|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.||units on a scale||Standard Deviation|Mean
838894|NCT01313312|Secondary|Physician's Global Assessment (PGA) of Treatment Response at Week 4|The PGA is a 9-point rating scale: -4=markedly worse, -3=much worse, -2=worse, -1=slightly worse, 0=no change, +1=slightly improved, +2=improved, +3=much improved, +4=markedly improved. An assessment of overall treatment response was conducted by the investigator and the mean PGA scores during long-term open label treatment with Dysport were reported.|At Week 4|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.||units on a scale||Standard Deviation|Mean
838895|NCT01313312|Secondary|Mean Change From Baseline MAS in the Shoulder Extensors at Week 4|The clinical assessment of muscle tone was performed using the MAS. The MAS consists of 6 grades: 0, 1, 1+, 2, 3, or 4 that can be applied to muscles of both the upper and lower limbs. The MAS was applied by the rater by stretching the joint through its full available range over 1 second. The mean changes from baseline to Week 4 in MAS in the shoulder extensors are reported.|At Week 4|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.||units on a scale||Standard Deviation|Mean
838896|NCT01313312|Secondary|Percentage of Subjects With at Least 1 or 2 Grade Reduction in MAS for Elbow Flexors at Week 4|The MAS consists of 6 grades: 0, 1, 1+, 2, 3, or 4 that can be applied to muscles of both the upper and lower limbs. The MAS was applied by the rater by stretching the joint through its full available range over 1 second. The percentage of subjects at least a 1 grade reduction and at least a 2 grades reduction from baseline in mean MAS in the elbow flexors at Week 4 are reported.|At Week 4|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.||percentage of subjects|||Number
838897|NCT01313312|Secondary|Mean Change From Baseline MAS in the Elbow Flexors at Week 4|The clinical assessment of muscle tone was performed using the MAS. The MAS consists of 6 grades: 0, 1, 1+, 2, 3, or 4 that can be applied to muscles of both the upper and lower limbs. The MAS was applied by the rater by stretching the joint through its full available range over 1 second. The mean changes from baseline to Week 4 in MAS in the elbow flexors are reported.|At Week 4|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.||units on a scale||Standard Deviation|Mean
838898|NCT01313312|Secondary|Percentage of Subjects With at Least 1 or 2 Grade Reduction in MAS for Wrist Flexors at Week 4|The MAS consists of 6 grades: 0, 1, 1+, 2, 3, or 4 that can be applied to muscles of both the upper and lower limbs. The MAS was applied by the rater by stretching the joint through its full available range over 1 second. The percentage of subjects with at least a 1 grade reduction and at least a 2 grades reduction in mean MAS in the wrist flexors at Week 4 are reported.|At Week 4|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.||percentage of subjects|||Number
838899|NCT01313312|Secondary|Mean Change From Baseline MAS in the Wrist Flexors at Week 4|The clinical assessment of muscle tone was performed using the MAS. The MAS consists of 6 grades: 0, 1, 1+, 2, 3, or 4 that can be applied to muscles of both the upper and lower limbs. The MAS was applied by the rater by stretching the joint through its full available range over 1 second. The mean changes from baseline to Week 4 in MAS in the wrist flexors are reported.|At Week 4|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.||units on a scale||Standard Deviation|Mean
838901|NCT01313312|Secondary|Mean Change From Baseline MAS in the Extrinsic Finger Flexors at Week 4|The clinical assessment of muscle tone was performed using the MAS. The MAS consists of 6 grades: 0, 1, 1+, 2, 3, or 4 that can be applied to muscles of both the upper and lower limbs. The MAS was applied by the rater by stretching the joint through its full available range over 1 second. The mean changes from baseline to Week 4 in MAS in the extrinsic finger flexors are reported.|At Week 4|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.||units on a scale||Standard Deviation|Mean
838902|NCT01313312|Secondary|Percentage of Subjects With at Least 1 or 2 Grade Reduction in MAS for Overall PTMG|The MAS consists of 6 grades: 0, 1, 1+, 2, 3, or 4 that can be applied to muscles of both the upper and lower limbs. The MAS was applied by the rater by stretching the joint through its full available range over 1 second. The percentage of subjects with at least a 1 grade reduction and at least a 2 grades reduction from baseline in mean MAS in the overall PTMG at Week 4 are reported.|At Week 4|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.||percentage of participants|||Number
838903|NCT01313312|Secondary|Mean Change From Baseline Modified Ashworth Scale (MAS) in the Overall Primary Targeted Muscle Group (PTMG) for Upper Limb at Week 4|The clinical assessment of muscle tone was performed using the MAS. The MAS consists of 6 grades: 0, 1, 1+, 2, 3, or 4 that can be applied to muscles of both the upper and lower limbs. The MAS was applied by the rater by stretching the joint through its full available range over 1 second. The mean changes from baseline to Week 4 in MAS in the overall PTMG (finger, wrist or elbow flexors) are reported.|At Week 4|The Intent-to-Treat (ITT) population was all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.||units on a scale||Standard Deviation|Mean
838904|NCT01313312|Primary|Number of Subjects With Botulinum Toxin A Binding and Neutralising Putative Antibodies|Blood samples were collected at baseline, Week 4 of each cycle, and at the end of study/early withdrawal to test for the presence of Botulinum Toxin A Binding antibodies. Samples positive for the presence of binding antibodies were then analysed for the presence of neutralising putative antibodies. The number of subjects who were either positive (+ve) or negative (-ve) at baseline and then positive post baseline for binding or neutralising antibodies were reported.|Up to Week 52|Binding and neutralising antibodies were evaluated at baseline for all 258 subjects (rollover and de novo) enrolled in Study 148. Only subjects with data available for analysis at the point of testing are reported.||Participants|||Number
838905|NCT01313312|Primary|Mean Change From Baseline to End of Study/Early Withdrawal in 12 Lead ECG - HR|HR was measured by 12-lead ECG tracing, performed at baseline, at post treatment follow up visit Week 4, and at the end of study or early withdrawal visit. The 12-lead ECG recordings were performed at a paper speed of 25 mm/s, recorded with the subject in a supine position after 5 minutes rest.|Up to Week 52|The ECG analysis was performed in the safety population among subjects who had at least one ECG measurement before injection and at least one ECG after injection. Only subjects with data available for analysis at the point of testing are reported.||bpm||Standard Deviation|Mean
838906|NCT01313312|Primary|Mean Change From Baseline to End of Study/Early Withdrawal in Blood Urea Nitrogen (BUN) and Fasting Blood Glucose|Blood samples for analysis of BUN and fasting blood glucose levels were taken at baseline, at post treatment follow up visit Week 4, and at end of study/early withdrawal.|Up to Week 52|Subjects who entered the study and received at least one open label injection of Dysport® were evaluated for safety analysis. Only subjects with data available for analysis at the point of testing are reported.||millimoles(mmol)/L||Full Range|Mean
838907|NCT01313312|Primary|Mean Change From Baseline to End of Study/Early Withdrawal in Total Bilirubin and Creatinine|Blood samples for clinical chemistry analysis of total bilirubin and creatinine were taken at baseline, at post treatment follow up visit Week 4, and at end of study/early withdrawal. Outcome measure is reported for number of subjects with data available for analysis.|Up to Week 52|Subjects who entered the study and received at least one open label injection of Dysport® were evaluated for safety analysis. Only subjects with data available for analysis at the point of testing are reported.||Micromole/L (μmol/L)||Full Range|Mean
838908|NCT01313312|Primary|Mean Change From Baseline to End of Study/Early Withdrawal in Alkaline Phosphatase (ALP), Gamma Glutamyl Transferase (GGT), Serum Glutamic Oxaloacetic Transaminase (SGOT) and Serum Glutamic Pyruvic Transaminase (SGPT)|Blood samples for analysis of the following clinical chemistry parameters: ALP, GGT, SGOT and SGPT were taken at baseline, at post treatment follow up visit Week 4, and at end of study/early withdrawal. Outcome measure is reported for number of subjects with data available for analysis.|Up to Week 52|Subjects who entered the study and received at least one open label injection of Dysport® were evaluated for safety analysis. Only subjects with data available for analysis at the point of testing are reported.||International Unit/L (IU/L)||Full Range|Mean
838909|NCT01313312|Primary|Mean Change From Baseline to End of Study/Early Withdrawal in 12-Lead Electrocardiogram (ECG)|12-lead ECG tracing was performed at baseline, post treatment at Week 4 and at the end of study/early withdrawal visit. The 12-lead ECG recordings were performed at a paper speed of 25 mm/s, recorded with the subject in a supine position after 5 minutes rest. The ECG parameters reported were QRS duration, PR duration, QT duration, QTcB (QT interval corrected for HR according to Bazett), and QTcF (QT interval corrected for HR according to Fridericia) at baseline and the change to end of study/early withdrawal visit (EOS).|Up to Week 52|The ECG analysis was performed in the safety population among subjects who had at least one ECG measurement before injection and at least one ECG after injection. Only subjects with data available for analysis at the point of testing are reported.||milliseconds (ms)||Standard Deviation|Mean
838922|NCT01313494|Secondary|Mean Rate of Moderate or Severe COPD Exacerbations Per Patient Per Year|The mean rate of COPD exacerbations per patient per year rate = (number of exacerbations per treatment group/time to study withdrawal per treatment group) * 365. COPD exacerbations were categorized as follows: - Severe: Requiring hospitalization and/or leading to death; - Moderate: Requiring oral or parenteral glucocorticosteroid therapy.|24 weeks|Intent-to-treat||exacerbations per patient per year|||Number
838911|NCT01313312|Primary|Mean Change From Baseline to End of Study/Early Withdrawal in Mean Corpuscular Volume (MCV)|Blood samples for MCV were taken at baseline, at post treatment follow up visit Week 4, and at end of study/early withdrawal. Outcome measure is reported for number of subjects with data available for analysis.|Up to Week 52|Subjects who entered the study and received at least one open label injection of Dysport® were evaluated for safety analysis. Only subjects with data available for analysis at the point of testing are reported.||femtoliters (fL)||Full Range|Mean
838912|NCT01313312|Primary|Mean Change From Baseline to End of Study/Early Withdrawal in Mean Corpuscular Haemoglobin (MCH)|Blood samples for MCH were taken at baseline, at post treatment follow up visit Week 4, and at end of study/early withdrawal. Outcome measure is reported for number of subjects with data available for analysis.|Up to Week 52|Subjects who entered the study and received at least one open label injection of Dysport® were evaluated for safety analysis. Only subjects with data available for analysis at the point of testing are reported.||picograms (pg)||Full Range|Mean
838913|NCT01313312|Primary|Mean Change From Baseline to End of Study/Early Withdrawal in Haematocrit|Blood samples for haematocrit were taken at baseline, at post treatment follow up visit Week 4, and at end of study/early withdrawal. Outcome measure is reported for number of subjects with data available for analysis.|Up to Week 52|Subjects who entered the study and received at least one open label injection of Dysport® were evaluated for safety analysis. Only subjects with data available for analysis at the point of testing are reported.||percentage of RBC in blood||Full Range|Mean
838914|NCT01313312|Primary|Mean Change From Baseline to End of Study/Early Withdrawal in Haemoglobin and Mean Corpuscular Haemoglobin Concentration (MCHC)|Blood samples for haemoglobin and MCHC were taken at baseline, at post treatment follow up visit Week 4, and at the end of study/early withdrawal. Outcome measure is reported for number of subjects with data available for analysis.|Up to Week 52|Subjects who entered the study and received at least one open label injection of Dysport® were evaluated for safety analysis. Only subjects with data available for analysis at the point of testing are reported.||grams(g)/L||Full Range|Mean
838915|NCT01313312|Primary|Mean Change From Baseline to End of Study/Early Withdrawal in Red Blood Cell (RBC) Count|Blood samples for RBC count were taken at baseline, at post treatment follow up visit Week 4, and at end of study/early withdrawal. Outcome measure is reported for number of subjects with data available for analysis.|Up to Week 52|Subjects who entered the study and received at least one open label injection of Dysport® were evaluated for safety analysis. Only subjects with data available for analysis at the point of testing are reported.||Tera cells/Litre (L)||Full Range|Mean
838916|NCT01313312|Primary|Mean Change From Baseline to End of Study/Early Withdrawal in Heart Rate (HR)|HR was recorded at screening, baseline and at each post baseline visit. Vital signs were measured with the subject in a sitting position after resting for 3 minutes. Outcome measure is reported for number of subjects with data available for analysis.|Up to Week 52|Subjects who entered the study and received at least one open label injection of Dysport® were evaluated for safety analysis. Only subjects with data available for analysis at the point of testing are reported.||Beats per minute (bpm)||Full Range|Mean
838917|NCT01313312|Primary|Mean Change From Baseline to End of Study/Early Withdrawal in Diastolic and Systolic Blood Pressure (BP)|Systolic and diastolic BP were recorded at screening, baseline and at each post baseline visit. Vital signs were measured with the subject in a sitting position after resting for 3 minutes. Outcome measure is reported for number of subjects with data available for analysis.|Up to Week 52|Subjects who entered the study and received at least one open label injection of Dysport® were evaluated for safety analysis. Only subjects with data available for analysis at the point of testing are reported.||Millimeters of Mercury (mm Hg)||Full Range|Mean
838918|NCT01313312|Primary|Assessment of the Long-term Safety of Dysport® Through the Collection of Treatment Emergent Adverse Events (TEAEs)|A TEAE was reported as emergent if it arose (i.e. started or worsened in severity) in the treatment phase after the subject received study medication. Adverse events of special interest (AESIs) were identified as those assessed as being due to remote spread of effect of Dysport®, or any adverse event (AE) that was assessed as a hypersensitivity reaction. TEAEs, AESIs, severe TEAEs, serious adverse events (SAEs), treatment related TEAEs, TEAEs leading to withdrawal and fatal SAEs are summarised by treatment cycle.|Up to Week 52|Subjects who entered the study and received at least one open label injection of Dysport® were evaluated for safety analysis. Only subjects with data available for analysis at the point of testing are reported.||Participants|||Number
838919|NCT01313494|Secondary|Number of Participants With Adverse Events|An adverse event (AE) is any untoward medical occurrence in a clinical trial participant regardless of causal relationship to study drug and regardless whether study drug has been administered. A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. A non-serious AE is any AE that does not meet the criteria above. Each AE was assessed by the Investigator as either 'related' or 'not related' to study drug.|24 weeks|Safety population, all randomized patients who took at least 1 dose of the trial treatment after randomization.||participants|||Number
838920|NCT01313494|Secondary|Time to Onset of Second Moderate or Severe COPD Exacerbation|Time to onset of a COPD exacerbation is defined as onset date of COPD exacerbation – date of first intake of study drug + 1 day. At least 10 days between the stop date of an exacerbation and the start date of the following exacerbation was required for these to be be considered as two separate COPD exacerbations. COPD exacerbations were categorized as follows: - Severe: Requiring hospitalization and/or leading to death; - Moderate: Requiring oral or parenteral glucocorticosteroid therapy.|24 weeks|Intent-to-treat population who experienced a second moderate to severe COPD exacerbation.||days||Full Range|Median
838921|NCT01313494|Secondary|Time to Onset of First Moderate or Severe COPD Exacerbation|Time to onset of a COPD exacerbation is defined as onset date of COPD exacerbation – date of first intake of study drug + 1 day. COPD exacerbations were categorized as follows: - Severe: Requiring hospitalization and/or leading to death; - Moderate: Requiring oral or parenteral glucocorticosteroid therapy.|24 weeks|Intent-to-treat population with at least one moderate or severe exacerbation||days||Full Range|Median
838923|NCT01313494|Secondary|Percentage of Participants With Moderate or Severe COPD Exacerbations|A COPD exacerbation is an event characterised by a worsening in the patient’s baseline dyspnoea, or cough and/or sputum beyond day-to-day variability sufficient to warrant a change in management, and may be accompanied by increased wheeze, chest tightness, purulent sputum and symptoms of cold and/or fatigue. COPD exacerbations were categorized as follows: - Severe: Requiring hospitalization and/or leading to death; - Moderate: Requiring oral or parenteral glucocorticosteroid therapy.|24 weeks|Intent-to-treat||percentage of participants|||Number
838924|NCT01313494|Secondary|Transition Dyspnoea Index (TDI) Total Score at Week 24|"The TDI is a recognized questionnaire to measure dyspnoea (shortness of breath) in patients with COPD. Questions from the TDI were used to assess the 3 components: change in functional impairment, change in magnitude of task and change in magnitude of effort. Transitions or changes from baseline are rated from -3 (major deterioration) to +3 (major improvement), and summed to give a total score ranging from -9 to +9. Least squares means (LSM) are from a repeated measures ANCOVA model with treatment, baseline value, time and a treatment-by-time interaction as independent variables."|Baseline to Week 24|Intent-to-treat population with available data.||units on a scale||Standard Error|Least Squares Mean
838925|NCT01313494|Secondary|Change From Baseline in Use of Rescue Medication|Salbutamol (given by metered dose inhaler and spacer) was used as rescue medication according to the individual needs of a patient. Each use was documented in the patient’s paper diary. Least squares means (LSM) are from a repeated measures ANCOVA model with treatment, baseline value, time and a treatment-by-time interaction as independent variables.|Baseline to Week 24|Intent-to-treat population with available data.||puffs/day||Standard Error|Least Squares Mean
838926|NCT01313494|Secondary|Change From Baseline in COPD Symptom Scores|Symptoms of chronic bronchitis with respect to cough and sputum production were assessed daily by the patient and recorded in a diary. Symptoms were assessed on a 4-point scale as follows: Cough: 0: no cough; 1: mild cough (at some time during the day); 2: moderate cough (regularly during the day); 3: severe cough (never free of cough or feeling free of need to cough). Sputum production: 0: no sputum production (unnoticeable); 1: mild sputum production (noticeable as a problem); 2: moderate sputum production (frequent inconvenience); 3: severe sputum production (constant problem). Change from Baseline is reported for cough and sputum separately, and for the sum of the 2 scores (range 0 - 6). Least squares means (LSM) are from a repeated measures ANCOVA model with treatment, baseline value, time and a treatment-by-time interaction as independent variables.|Baseline to Week 24|Intent-to-treat population with available data.||units on a scale||Standard Error|Least Squares Mean
838927|NCT01313494|Secondary|Change From Baseline in Post-bronchodilator Ratio of Forced Expiratory Volume After 1 Second to Forced Expiratory Volume After 6 Seconds|The FEV1/FEV6 ratio represents the percentage of the volume of air expired in the first six seconds that is expelled from the lungs during the first second of a forced exhalation. Pulmonary function testing was performed using centralized spirometry prior to taking study medication. Post-bronchodilator measurements were taken 30 minutes after four inhalations of 100 μg salbutamol.|Baseline and Week 24|Intent-to-treat population with available data; last observation carried forward (LOCF) was used.||percentage of FEV1/FEV6||Full Range|Mean
838928|NCT01313494|Secondary|Change From Baseline in Pre-bronchodilator Ratio of Forced Expiratory Volume After 1 Second to Forced Expiratory Volume After 6 Seconds|The FEV1/FEV6 ratio represents the percentage of the volume of air expired in the first six seconds that is expelled from the lungs during the first second of a forced exhalation. Pulmonary function testing was performed using centralized spirometry prior to taking study medication.|Baseline and Week 24|Intent-to-treat population with available data; last observation carried forward (LOCF) was used.||percentage of FEV1/FEV6||Full Range|Median
838929|NCT01313494|Secondary|Change From Baseline in Post-bronchodilator Ratio of Forced Expiratory Volume After 1 Second to Forced Vital Capacity|The FEV1/FVC ratio represents the percentage of vital capacity expelled from the lungs during the first second of a forced exhalation. Pulmonary function testing was performed using centralized spirometry prior to taking study medication. Post-bronchodilator measurements were taken 30 minutes after four inhalations of 100 μg salbutamol.|Baseline and Week 24|Intent-to-treat population with available data; last observation carried forward (LOCF) was used.||percent FEV1/FVC||Full Range|Median
838930|NCT01313494|Secondary|Change From Baseline in Pre-bronchodilator Ratio of Forced Expiratory Volume After 1 Second to Forced Vital Capacity|The FEV1/FVC ratio represents the percentage of vital capacity expelled from the lungs during the first second of a forced exhalation. Pulmonary function testing was performed using centralized spirometry prior to taking study medication.|Baseline and Week 24|Intent-to-treat population with available data; last observation carried forward (LOCF) was used.||percent FEV1/FVC||Full Range|Median
838931|NCT01313494|Secondary|Change From Baseline in Post-bronchodilator Peak Expiratory Flow Rate (PEF)|PEF is the maximal flow (or speed) achieved during the maximally forced expiration initiated at full inspiration. Pulmonary function testing was performed using centralized spirometry prior to taking study medication. Post-bronchodilator measurements were taken 30 minutes after four inhalations of 100 μg salbutamol. Change from baseline over 24 weeks of treatment was calculated from a repeated measures analysis of covariance (ANCOVA) model with treatment, baseline value, time and a treatment-by-time interaction as independent variables.|Baseline to Week 24|Intent-to-treat population with available data.||liters/minute||Standard Error|Least Squares Mean
838932|NCT01313494|Secondary|Change From Baseline in Pre-bronchodilator Peak Expiratory Flow Rate (PEF)|PEF is the maximal flow (or speed) achieved during the maximally forced expiration initiated at full inspiration. Pulmonary function testing was performed using centralized spirometry prior to taking study medication. Change from baseline over 24 weeks of treatment was calculated from a repeated measures analysis of covariance (ANCOVA) model with treatment, baseline value, time and a treatment-by-time interaction as independent variables.|Baseline to Week 24|Intent-to-treat population with available data.||liters/minute||Standard Error|Least Squares Mean
838943|NCT01313507|Primary|Percentage of Participants Who Experienced at Least 1 Adverse Event Temporally Related to the Study Drug|An adverse event was considered to be temporally related to the study drug if it started during an infusion or within 72 hours after the end of an infusion.|Baseline (follow-up visit of study NGAM-01) to the end of the study (follow-up visit of study NGAM-05) (up to 4 months)|Safety analysis set: All participants who received at least 1 dose of NewGam.||Percentage of participants|||Number
838933|NCT01313494|Secondary|Change From Baseline in Post-bronchodilator Forced Expiratory Volume in First Six Seconds (FEV6)|FEV6 is the amount of air which can be forcibly exhaled from the lungs in the first three seconds of a forced exhalation. Pulmonary function testing was performed using centralized spirometry prior to taking study medication. Post-bronchodilator measurements were taken 30 minutes after four inhalations of 100 μg salbutamol. Change from baseline over 24 weeks of treatment was calculated from a repeated measures analysis of covariance (ANCOVA) model with treatment, baseline value of post-bronchodilator FEV6, time and a treatment-by-time interaction as independent variables.|Baseline to Week 24|Intent-to-treat population with available data.||liters||Standard Error|Least Squares Mean
838934|NCT01313494|Secondary|Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in First Six Seconds (FEV6)|FEV6 is the amount of air which can be forcibly exhaled from the lungs in the first six seconds of a forced exhalation. Pulmonary function testing was performed using centralized spirometry prior to taking study medication. Change from baseline over 24 weeks of treatment was calculated from a repeated measures analysis of covariance (ANCOVA) model with treatment, baseline value of pre-bronchodilator FEV6, time and a treatment-by-time interaction as independent variables.|Baseline to Week 24|Intent-to-treat population with available data.||liters||Standard Error|Least Squares Mean
838935|NCT01313494|Secondary|Change From Baseline in Post-bronchodilator Forced Expiratory Volume in First Three Seconds (FEV3)|FEV3 is the amount of air which can be forcibly exhaled from the lungs in the first three seconds of a forced exhalation. Pulmonary function testing was performed using centralized spirometry prior to taking study medication. Post-bronchodilator measurements were taken 30 minutes after four inhalations of 100 μg salbutamol. Change from baseline over 24 weeks of treatment was calculated from a repeated measures analysis of covariance (ANCOVA) model with treatment, baseline value of post-bronchodilator FEV3, time and a treatment-by-time interaction as independent variables.|Baseline to Week 24|Intent-to-treat population with available data.||liters||Standard Error|Least Squares Mean
838936|NCT01313494|Secondary|Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in First Three Seconds (FEV3)|FEV3 is the amount of air which can be forcibly exhaled from the lungs in the first three seconds of a forced exhalation. Pulmonary function testing was performed using centralized spirometry prior to taking study medication. Change from baseline over 24 weeks of treatment was calculated from a repeated measures analysis of covariance (ANCOVA) model with treatment, baseline value of pre-bronchodilator FEV3, time and a treatment-by-time interaction as independent variables.|Baseline to Week 24|Intent-to-treat population with available data.||liters||Standard Error|Least Squares Mean
838937|NCT01313494|Secondary|Change From Baseline in Post-bronchodilator Forced Expiratory Flow 25-75%|Forced expiratory flow 25-75% (FEF25-75%) is the flow (or speed) of air coming out of the lung during the middle half of a forced expiration. Pulmonary function testing was performed using centralized spirometry prior to taking study medication. Post-bronchodilator measurements were taken 30 minutes after four inhalations of 100 μg salbutamol. Change from baseline over 24 weeks of treatment was calculated from a repeated measures analysis of covariance (ANCOVA) model with treatment, baseline value, time and a treatment-by-time interaction as independent variables.|Baseline to Week 24|Intent-to-treat population with available data.||liters/second||Standard Error|Least Squares Mean
838938|NCT01313494|Secondary|Change From Baseline in Pre-bronchodilator Forced Expiratory Flow 25-75%|Forced expiratory flow 25-75% (FEF25-75%) is the flow (or speed) of air coming out of the lung during the middle half of a forced expiration. Pulmonary function testing was performed using centralized spirometry prior to taking study medication. Change from baseline over 24 weeks of treatment was calculated from a repeated measures analysis of covariance (ANCOVA) model with treatment, baseline value, time and a treatment-by-time interaction as independent variables.|Baseline to Week 24|Intent-to-treat population with available data.||liters/second||Standard Error|Least Squares Mean
838939|NCT01313494|Secondary|Change From Baseline in Post-bronchodilator Forced Vital Capacity (FVC)|Vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Pulmonary function testing was performed using centralized spirometry prior to taking study medication. Post-bronchodilator measurements were taken 30 minutes after four inhalations of 100 μg salbutamol. Change from baseline over 24 weeks of treatment was calculated from a repeated measures analysis of covariance (ANCOVA) model with treatment, baseline value, time and a treatment-by-time interaction as independent variables.|Baseline to Week 24|Intent-to-treat population with available data.||liters||Standard Error|Least Squares Mean
838940|NCT01313494|Secondary|Change From Baseline in Pre-bronchodilator Forced Vital Capacity (FVC)|Vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Pulmonary function testing was performed using centralized spirometry prior to taking study medication. Change from baseline over 24 weeks of treatment was calculated from a repeated measures analysis of covariance (ANCOVA) model with treatment, baseline value, time and a treatment-by-time interaction as independent variables.|Baseline to Week 24|Intent-to-treat population with available data.||liters||Standard Error|Least Squares Mean
838941|NCT01313494|Secondary|Change From Baseline in Post-bronchodilator FEV1|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Pulmonary function testing was performed using centralized spirometry prior to taking study medication. Post-bronchodilator measurements were taken 30 minutes after four inhalations of 100 μg salbutamol. Change from baseline over 24 weeks of treatment was calculated from a repeated measures analysis of covariance (ANCOVA) model with treatment, baseline value of post-bronchodilator FEV1, time and a treatment-by-time interaction as independent variables.|Baseline to Week 24|Intent-to-treat population with available data.||liters||Standard Error|Least Squares Mean
838942|NCT01313494|Primary|Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1)|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Pulmonary function testing was performed using centralized spirometry prior to taking study medication. Change from baseline over 24 weeks of treatment was calculated from a repeated measures analysis of covariance (ANCOVA) model with treatment, baseline value of pre-bronchodilator FEV1, time and a treatment-by-time interaction as independent variables.|Baseline to Week 24|Intent-to-treat population included all randomly assigned patients who took at least 1 dose of trial treatment after randomization. Patients were assigned to the treatment group based on the treatment to which they were randomly assigned. Only patients with available data at Baseline and with at least 1 post-baseline measurement are included.||liters||Standard Error|Least Squares Mean
838944|NCT01313507|Primary|Percentage of Participants Who Experienced at Least 1 Adverse Event Causally Related to the Administration of the Study Drug|An adverse event was considered to be causally related to the administration of the study drug if it judged to be probably or possibly related to the study drug, as assessed by the investigator.|Baseline (follow-up visit of study NGAM-01) to the end of the study (follow-up visit of study NGAM-05) (up to 4 months)|Safety analysis set: All participants who received at least 1 dose of NewGam.||Percentage of participants|||Number
838945|NCT01313507|Secondary|Change From Baseline in the Quality of Life (QoL) at the End of the Study|QoL was assessed with the Child Health Questionnaire-Parent Form (CHQ-PF50), completed by a parent or guardian, in participants < 14 years of age at the start of the previous study NGAM-01 and with the Short Form-36 Health Survey (SF-36-HS) in participants ≥ 14 years of age. The CHQ-PF50 consists of 50 items organized into 15 subscales.The 15 subscales could be combined into 2 summary scores, physical and psychosocial. The calculated scores were transformed so that each scale had a range of 0-100. A higher score indicates better health. The SF-36-HS is composed of 36 items. Responses to the 36 items were combined to create 8 scales. The 8 scales could be further combined into 2 scores: Physical component summary and mental component summary. The item and scale scores were transformed to a range of 0-100 with a mean of 50 and a standard deviation of 10 in the general US population. A higher score indicates better health. For both instruments, a positive change indicates improvement.|Baseline (follow-up visit of study NGAM-01) to the end of the study (follow-up visit of study NGAM-05) (up to 4 months)|Safety analysis set: All participants who received at least 1 dose of NewGam.||Units on a scale||Standard Deviation|Mean
838946|NCT01313520|Secondary|Change From Baseline in Standardized Z-scores of Composite Endpoint Consisting of Clinical Disease Activity Measure DAS28 CRP + Rheumatoid Arthritis MRI Score (RAMRIS) Synovitis + RAMRIS Osteitis.|"DAS28 CRP is a composite index of the following: number of tender joints (28 joint count), number of swollen joints (28 joint count), GADP on a 100 mm VAS and concentration of CRP. RAMRIS Synovitis is an ordinal scoring system of hand synovitis that is scored from 0 to 3 in 8 locations, ranging from 0 to 24 total. RAMRIS Osteitis is an ordinal scoring system of hand osteitis that is scored from 0 to 3 in 25 locations, ranging from 0 to 75 total. The individual
endpoints are standardized using z-scores, then the z-scores are averaged to create a composite endpoint by use of O'Brien's global statistic."|Baseline and Week 14|Participants treated with Infliximab or placebo||Z-score||95% Confidence Interval|Least Squares Mean
838947|NCT01313520|Secondary|Change From Baseline in Standardized Z-scores of Composite Endpoint Consisting of Clinical Disease Activity Measure DAS28 CRP + Ktrans.|Clinical disease activity score (DAS28 CRP) is a composite index of the following: number of tender joints (28 joint count), number of swollen joints (28 joint count), Patient Global Assessment of Disease Status (GADP) on a 100 mm visual analog scale (VAS) and concentration of CRP. Ktrans is the volume transfer rate from the blood plasma to the enhancing synovium. The individual endpoints are standardized using z-scores, then the z-scores are averaged to create a composite endpoint by use of O'Brien's global statistic.|Baseline and Week 14|Participants treated with Infliximab or placebo||Z-score||95% Confidence Interval|Least Squares Mean
838948|NCT01313520|Other Pre-specified|Change From Baseline in RAMRIS Osteitis.|RAMRIS Osteitis is an ordinal scoring system of hand osteitis that is scored from 0 to 3 in 25 locations. The scores can range from 0 to 75, with higher values corresponding to higher disease activity, and lower values to better outcomes.|Baseline and Week 14|Participants treated with infliximab or placebo. One participant in the placebo group missing a baseline value was not included in the analysis.||units on a scale||Standard Deviation|Mean
838949|NCT01313520|Other Pre-specified|Change From Baseline in RAMRIS Synovitis.|RAMRIS Synovitis is an ordinal scoring system of hand synovitis that is scored from 0 to 3 in 8 locations. The scores can range from 0 to 24, with higher values corresponding to higher disease activity, and lower values to better outcomes.|Baseline and Week 14|Participants treated with infliximab or placebo||units on a scale||Standard Deviation|Mean
838950|NCT01313520|Other Pre-specified|Change From Baseline in DAS28 CRP.|DAS28 CRP is a composite index of the following: number of tender joints (28 joint count), number of swollen joints (28 joint count), GADP on a 100 mm VAS and concentration of serum CRP. Scores can range from 2-10; with higher values corresponding to higher disease activity, and lower values to better outcomes.|Baseline and Week 14|Participants treated with infliximab or placebo||units on a scale||95% Confidence Interval|Least Squares Mean
838951|NCT01313520|Secondary|Percentage of Responders With a 50% Improvement From Baseline in American College of Rheumatology (ACR) Responder Criteria for Tender and Swollen Joints (ACR50).|ACR50 requires that both tender and swollen joint counts improve by at least 50% from baseline, as well as a 50% improvement in at least 3 other core measures from the following: pain, patient's and physician's global assessment, physical disability and CRP.|Baseline and week 14|Participants treated with Infliximab or placebo||percentage of responders||90% Confidence Interval|Number
838952|NCT01313520|Secondary|Percentage of Responders With a 20% Improvement From Baseline in American College of Rheumatology (ACR) Responder Criteria for Tender and Swollen Joints (ACR20).|ACR20 requires that both tender and swollen joint counts improve by at least 20% from baseline, as well as a 20% improvement in at least 3 other core measures from the following: pain, patient's and physician's global assessment, physical disability and C-reactive protein (CRP).|Baseline and week 14|Participants treated with Infliximab or Placebo||percentage of responders||90% Confidence Interval|Number
838953|NCT01313520|Primary|Change From Baseline in the Volume Transfer Rate From the Blood Plasma to the Enhancing Synovium (Ktrans)|Dynamic Contrast Enhanced (DCE) Magnetic Resonance Imaging (MRI) was performed on one hand at baseline, and then at treatment week 14 to measure the rate constant of transfer of contrast (Ktrans).|Baseline and week 14|Participants treated with infliximab or placebo||min ^-1||95% Confidence Interval|Least Squares Mean
838954|NCT01320943|Secondary|Proportion of Participants With HBsAg Loss at Week 96 in Both Study Arms|HBsAg loss is defined as qualitative HBsAg result changing from positive at baseline (BL) to negative at any post-baseline visit. Proportions are based on a Kaplan-Meier estimate.|Week 96|HBsAg Loss and Seroconversion Full Analysis Set||Proportion of participants||95% Confidence Interval|Number
838969|NCT01322594|Primary|Incidence of Clinically Significant Vital Signs Results|Number of participants experiencing clinically significant vital signs results. A clinically significant vital signs result is defined as an abnormal vital signs result that results in a treatment-emergent adverse event.|Days 1 - 92|All 31 participants entered into the study received MEDI2338 or placebo and were included in the analysis||Participants|||Number
838955|NCT01320943|Secondary|Percentage of Participants With Alanine Aminotransferase (ALT) > Upper Limit of the Normal Range in the Stop TDF Arm (TDF-Free and Restart TDF)||Baseline to Week 144|Participants in the Full Analysis Set with available data were analyzed. Percentages are based on the number of participants with non-missing laboratory test results at each visit. One participant restarted TDF during Weeks 72 and 120 and thus was reported in both the Stop TDF and Re-Start TDF groups based on the date of TDF restart.||Percentage of participants|||Number
838956|NCT01320943|Secondary|Percentage of Participants With Viral Suppression in the Stop TDF Arm (TDF-Free and Re-Start TDF Groups)|Viral suppression is defined as 2 consecutive assessments of HBV DNA < 400 copies/mL (69 IU/mL) through Week 144.|Baseline to Week 144|Participants in the FAS with available data were analyzed. When participant randomized in the Stop TDF group restarted TDF therapy, that participant was considered part of the Restart TDF group from that point forward. 1 participant restarted TDF during Wk 72, thus was reported in both Stop TDF and Restart TDF arms based on the TDF restart date.||Percentage of participants|||Number
838957|NCT01320943|Secondary|Proportion of Participants Who Restart TDF Therapy in the Stop TDF Arm||Weeks 48, 96, and 144|Full Analysis Set (FAS): participants who were randomized to Stop TDF group and had a baseline visit or who were randomized to Continue TDF group and received at least 1 dose of study drug. Proportions are based on the Kaplan-Meier estimate.||Proportion of participants||95% Confidence Interval|Number
838958|NCT01320943|Secondary|Change From Baseline in Quantitative HBsAg (IU/mL) in Both Study Arms|"The analyses were summarized by 3 treatment subgroups: Stop TDF (TDF-Free), Restart TDF, and Continue TDF
When participant randomized in the Stop TDF group restarted TDF therapy, that participant was considered part of the Restart TDF group from that point forward. For Restart TDF group, baseline is defined as the last available record on or prior to the restart date of TDF."|Baseline to Week 144|Participants in the Full Analysis Set ( participants who were randomized to Stop TDF arm and had a baseline visit or who were randomized to Continue TDF arm and received at least 1 dose of study drug) with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
838959|NCT01320943|Secondary|Proportion of Participants With HBsAg Seroconversion in Both Study Arms at Weeks 96 and 144|HBsAg seroconversion is defined as qualitative HBsAb result changing from negative at baseline to positive at any postbaseline visit. Proportions are based on the Kaplan-Meier estimate.|Weeks 96 and 144|HBsAg Loss and Seroconversion Full Analysis Set: participants in the Full Analysis Set who had at least 1 post-baseline HBsAg value and with HBsAg positive and HBsAb negative or missing at baseline.||Proportion of participants||95% Confidence Interval|Number
838960|NCT01320943|Primary|Proportion of Participants With HBsAg Loss at Week 144 in Both Study Arms|HBsAg loss is defined as qualitative HBsAg result changing from positive at baseline (BL) to negative at any post-baseline visit. Proportions are based on a Kaplan-Meier estimate.|Week 144|HBsAg Loss and Seroconversion Full Analysis Set: participants in the Full Analysis Set who had at least one post-baseline HBsAg value and with HBsAg positive and HBsAb negative or missing at baseline.||Proportion of participants||95% Confidence Interval|Number
838961|NCT01321008|Primary|Progression-free Survival (PFS)|Progression-free survival (PFS) defined as time from treatment initiation day to first documented progressive disease or death due to disease. Reviewed with each 21-day treatment cycle, followed every 3-4 months for first 2 years, annually thereafter.|Day 1 to disease progression or death (up to 5+ years)|Study terminated early, no analysis available.|||||
838962|NCT01322594|Secondary|Clearance (CL)|CL of MEDI2338|Pre-dose (Day 1) and post-dose (Days 1 [end of infusion, and 30 minutes and 1, 3, 8, and 24 hours postinfusion], 2, 3, 5, 8, 10, 15, 22, 29, 36, 43, 57, 71, and 92)|Of the 31 participants who entered into the study and received MEDI2338 or placebo, 25 participants received only MEDI2338 and were included in the pharmacokinetic analysis||L/Days||Standard Deviation|Mean
838963|NCT01322594|Secondary|Apparent Terminal Elimination Phase Half-life (t1/2)|t1/2 of MEDI2338|Pre-dose (Day 1) and post-dose (Days 1 [end of infusion, and 30 minutes and 1, 3, 8, and 24 hours postinfusion], 2, 3, 5, 8, 10, 15, 22, 29, 36, 43, 57, 71, and 92)|Of the 31 participants who entered into the study and received MEDI2338 or placebo, 25 participants received only MEDI2338 and were included in the pharmacokinetic analysis||Days||Standard Deviation|Mean
838964|NCT01322594|Secondary|Observed Maximum Concentration (Cmax)|Cmax of MEDI2338|Pre-dose (Day 1) and post-dose (Days 1 [end of infusion, and 30 minutes and 1, 3, 8, and 24 hours postinfusion], 2, 3, 5, 8, 10, 15, 22, 29, 36, 43, 57, 71, and 92)|Of the 31 participants who entered into the study and received MEDI2338 or placebo, 25 participants received only MEDI2338 and were included in the pharmacokinetic analysis||ng/mL||Standard Deviation|Mean
838965|NCT01322594|Secondary|Incidence of Anti-drug Antibodies (ADA) to MEDI2338|Number of participants with ADA to MEDI2338|Days 1, 57, and 92|Of the 31 participants who entered into the study and received MEDI2338 or placebo, 25 participants received only MEDI2338 and were included in the analysis of ADA||Participants|||Number
838966|NCT01322594|Secondary|Area Under the Serum Concentration-Time Profile From Time Zero to the Last Measurable Time Point|Area under the serum concentration-time profile from time zero to the last measurable time point of MEDI2338|Pre-dose (Day 1) and post-dose (Days 1 [end of infusion, and 30 minutes and 1, 3, 8, and 24 hours postinfusion], 2, 3, 5, 8, 10, 15, 22, 29, 36, 43, 57, 71, and 92)|Of the 31 participants who entered into the study and received MEDI2338 or placebo, 25 participants received only MEDI2338 and were included in the pharmacokinetic analysis||ng x day/mL||Standard Deviation|Mean
838967|NCT01322594|Secondary|Area Under the Serum Concentration-Time Curve From Time Zero to Infinity|Area under the serum concentration-time curve from time zerio to infinity of MEDI2338|Pre-dose (Day 1) and post-dose (Days 1 [end of infusion, and 30 minutes and 1, 3, 8, and 24 hours postinfusion], 2, 3, 5, 8, 10, 15, 22, 29, 36, 43, 57, 71, and 92)|Of the 31 participants who entered into the study and received MEDI2338 or placebo, 25 participants received only MEDI2338 and were included in the pharmacokinetic analysis||ng x day/mL||Standard Deviation|Mean
838968|NCT01322594|Primary|Incidence of Clinically Significant Serum Chemistry Laboratory Results|Number of participants experiencing clinically significant serum chemistry laboratory results. A clinically significant serum chemistry laboratory result is defined as an abnormal serum chemistry laboratory result that results in a treatment-emergent adverse event.|Days 1 - 92|All 31 participants entered into the study received MEDI2338 or placebo and were included in the analysis||Participants|||Number
838970|NCT01322594|Primary|Incidence of Clinically Significant Electrocardiogram Results|Number of participants experiencing clinically significant electrocardiogram results. A clinically significant electrocardiogram result is defined as an abnormal electrocardiogram result that results in a treatment-emergent adverse event.|Days 1 - 92|All 31 participants entered into the study received MEDI2338 or placebo and were included in the analysis||Participants|||Number
838971|NCT01322594|Primary|Incidence of Clinically Significant Hematology Laboratory Results|Number of participants experiencing clinically significant hematology laboratory results. A clinically significant hematology laboratory result is defined as an abnormal hematology laboratory result that results in a treatment-emergent adverse event.|Days 1 - 92|All 31 participants entered into the study received MEDI2338 or placebo and were included in the analysis||Participants|||Number
838972|NCT01322594|Primary|Incidence of Serious Adverse Events|Number of participants experiencing serious adverse events|Days 1 - 92|All 31 participants entered into the study received MEDI2338 or placebo and were included in the analysis||Participants|||Number
838973|NCT01322594|Primary|Incidence of Adverse Events|Number of participants experiencing adverse events (includes both adverse events and serious adverse events)|Days 1 - 92|All 31 participants entered into the study received MEDI2338 or placebo and were included in the analysis||Participants|||Number
838974|NCT01322607|Secondary|Balance|Dynamic Gait Index - another measure related to balance and general function. It includes items of walking while changing speed, turning the head, pivot turning, walking over and around obstacles, and stair climbing. This index ranges from 0 - 24, with 24 representing a high level of balance and general function (the higher the score the better the balance).|3 months|||units on a scale||Standard Deviation|Mean
838975|NCT01322607|Secondary|Muscular Endurance|Muscular endurance performed on Leg Press and assessed by a force transducer, while seated. The longer the amount of time participant can maintain a force the better their muscular endurance.|3 months|||seconds||Standard Deviation|Mean
838976|NCT01322607|Secondary|Muscular Strength|Strength measured by torque of isokinetic maximal concentric knee extensor volitional contractions of paretic and non-paretic leg at multiple angular velocities (30, 90, and 120°/sec). The higher the number the higher the muscular strength. Also performed on resistance equipment for both the Leg Press and Leg Extension. The higher the number the stronger a person is.|3 months|||newtons (N)||Standard Deviation|Mean
838977|NCT01322607|Primary|Economy of Gait|Over-ground gait economy measured using a portable metabolic monitoring system, K4b2 during a 6 minute walk, with subjects walking at their comfortable self-selected walking speed while open circuit spirometry collects break-by-break data. The K4b2 consists of a small battery pack and portable gas analyser (weighing less than 1 kg) that participants wear on their chest. Attached to the portable system is a flexible rubber facemask with flowmeter used for breath-by-breath analysis. The mean rate of oxygen consumption (VO2) will be calculated based on the final 3 minutes of a 6-minute walk under steady state oxygen consumption conditions. A 6 minute walk is a distance most representative of community-based ambulatory capacity and is a sensitive outcome measure in exercise studies in chronic stroke subjects. The higher the VO2 used during the 6 minute walk, represents a less efficient economy of gait.|3 months|||ml/kg/min||Standard Deviation|Mean
838978|NCT01322633|Secondary|Incidence Rate of Overall Cancer|Incidence rate was expressed as cases per 100,000 person-years with 95 percent (%) confidence intervals. Incidence rates were estimated from 1 year after the index date and were censored at the earliest of following events: diagnosis of any type of cancer (excluding non-melanoma skin cancers), death, withdrawal from KPNC membership or end of the study, whichever occurred first for pantoprazole group. For other PPI group, data was also censored in case participants switched to pantoprazole group. Index date: the earliest date at which participant had achieved 240 days of study drug exposure within a 12 month time period before the study start date. Person-year was estimated by calculating all of the years that participants in a study were followed. Person-year calculations were adjusted for anticipated mortality based on United States (US) life tables.|1 year after index date up to diagnosis of any cancer, death, withdrawal from KPNC membership, date when other PPI participants switched to pantoprazole or end of the study (up to Year 7.5)|Analysis population included all participants who met the inclusion criteria.||incidence per 100000 person-years||95% Confidence Interval|Number
838979|NCT01322633|Secondary|Incidence Rate of Composite Gastrointestinal Cancers|Incidence rate was expressed as cases per 100,000 person-years with 95 percent (%) confidence intervals. Incidence rates were estimated from 1 year after the index date and were censored at the earliest of following events: diagnosis of cancer of colon, pancreas, liver or small intestine, death, withdrawal from KPNC membership or end of the study, whichever occurred first for pantoprazole group. For other PPI group, data was also censored in case participants switched to pantoprazole group. Index date: the earliest date at which participant had achieved 240 days of study drug exposure within a 12 month time period before the study start date. Person-year was estimated by calculating all of the years that participants in a study were followed. Person-year calculations were adjusted for anticipated mortality based on United States (US) life tables.|1 year after index date up to diagnosis of gastrointestinal cancer, death, withdrawal from KPNC membership, date when other PPI participants switched to pantoprazole or end of the study (up to Year 7.5)|Analysis population included all participants who met the inclusion criteria.||incidence per 100000 person-years||95% Confidence Interval|Number
838980|NCT01322633|Primary|Incidence Rate of Gastric Cancer|Incidence rate was expressed as cases per 100,000 person-years with 95 percent (%) confidence intervals. Incidence rates were estimated from 1 year after the index date and were censored at the earliest of following events: diagnosis of gastric cancer, death, withdrawal from KPNC membership or end of the study, whichever occurred first for pantoprazole group. For other PPI group, data was also censored in case participants switched to pantoprazole group. Index date: the earliest date at which participant had achieved 240 days of study drug exposure within a 12 month time period before the study start date. Person-year was estimated by calculating all of the years that participants in a study were followed. Person-year calculations were adjusted for anticipated mortality based on United States (US) life tables.|1 year after index date up to diagnosis of gastric cancer, death, withdrawal from KPNC membership, date when other PPI participants switched to pantoprazole or end of the study (up to Year 7.5)|Analysis population included all participants who met the inclusion criteria.||incidence per 100000 person-years||95% Confidence Interval|Number
838981|NCT01322815|Primary|Number of Participants Alive and Free of Progression at 4 Months (Patients Who Have Undergone Prior Therapy) and 10 Months (Untreated Patients)|Clinical benefit rate is defined as the proportion of patients alive and free of progression at 4 Months (Patients Who Have Undergone Prior Therapy) and 10 Months (Untreated Patients), assessed from first treatment with GI-4000. Progression is defined as CR (complete response) = disappearance of all target lesions; PR (partial response) = 30% decrease in the sum of the longest diameter of the target lesions; PD (progressive disease) = 20% increase in the sum of the longest diameter of the target lesions; or SD (stable disease) = small changes that do not meet the above criteria.|4 Months for patients who had undergone prior 1st-line therapy, and 10 months for previously untreated patients|Patients with RAS mutant positive metastatic colorectal cancer (CRC), either newly diagnosed, or having completed first line therapy with an oxaliplatin or irinotecan plus fluoropyrimidine and bevacizumab containing regimen.||participants|||Number
838982|NCT01322841|Secondary|Percentage of Patients Diagnosed With One of the Disorders||six months|||percentage of participants|||Number
838983|NCT01322841|Primary|Percentage of Patients Screened Positive for One of the Disorders||six months|||percentage of participants|||Number
838984|NCT01322945|Secondary|Test-retest Reliability of the ASK Nasal Inventory|First 12 endonasal and 10 control patients enrolled in the study completed the ASK Nasal Inventory at 90 days and 120 days post surgery to measure reliablity of the survey (they scored the 9-item instrument similarly at both time frames)comparing 5-point Likert scale scores. Pearson correlation was used to determine a correlation between each patient's responses at 90 days post op and 120 days post op.|90 days and 120 days post surgery|||Correlation Coefficient|||Number
838985|NCT01322945|Primary|Change in Mean Survey Response From Baseline to 90 Days Post Surgery|Mean survey response at 90 days post surgery between the control patients and the endonasal surgery patients using the Anterior skull base nasal inventory (ASK Nasal Inventory. A 5-point Likert scale for each question on the ASK Nasal inventory measures frequency of nasal symptoms where 1=never, 2= a little of the time, 3=some of the time, 4=most of the time, 5= all of the time. Total mean Likert scores were compared in the endonasal group to the control group after surgery. Scores range from minimum of 9 to maximum of 45. The lower the score the fewer the nasal complaints.|Baseline, 90 days post surgery|Power analyses were conducted to determine a sample size large enough to significantly detect change with 90% power using a pre- post research methodology.||units on a scale||Standard Deviation|Mean
838986|NCT01322971|Secondary|Infectious Morbidity (i.e. Chorioamnionitis, Neonatal Sepsis)||up to 2 years|No data were collected for this outcome|||||
838987|NCT01322971|Secondary|Miscarriage Rate (Loss of a Clinically Recognized Pregnancy)||up to 2 years|No data were collected for this outcome|||||
838988|NCT01322971|Secondary|Pregnancy Rate (Pregnancy Visible on Ultrasound)||up to 2 years|No data were collected for this outcome|||||
838989|NCT01322971|Primary|Biochemical Pregnancy Rate (Positive Pregnancy Test)|Biochemical pregnancy rate was defined as number of participants who had a positive pregnancy test|up to 2 years|No data were collected for this outcome|||||
838990|NCT01323010|Secondary|Admission Rates in Patients With the Arg16Gly Polymorphisms|Admission rates in patients with the Arg16Gly polymorphisms of the beta-2 adrenergic receptor (Arg16Gly, Arg16Arg and Gly16Gly genotypes).|at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment)|The sequencing of the beta-2 adrenergic receptor gene was performed in a subset of 60 patients, in the other samples these analysis were not feasible due to hemolysis.||participants|||Number
838991|NCT01323010|Secondary|Admission Rates in Patients With and Without Rhinovirus Detect|Admission rates in patients with and without rhinovirus detected by PCR in nasal lavage samples.|at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment)|We obtained nasal lavage samples from 117 individuals, in two patients it was not possible to collect nasal lavage samples.||percentage of participants|||Number
838992|NCT01323010|Secondary|Admission Rates in Patients With and Without Any Virus Detected|Admission rates in patients with and without any of the following viruses detected by PCR in nasal lavage samples: Adenovirus; Bocavirus; Coronavirus; Enterovirus (Echovirus); Influenza (A H3N2, A H1N1/2009, B and C); Metapneumovirus (subtypes A and B); Parainfluenza 1, 2, 3 and 4 (subtypes A and B); Rhinovirus; Respiratory Syncytial Virus type A and Respiratory Syncytial Virus type B.|at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment)|We obtained nasal lavage samples from 117 individuals, in two patients it was not possible to collect nasal lavage samples.||percentage of participants|||Number
838993|NCT01323010|Secondary|Lengths of Stay in the Emergency Room|lengths of stay in the emergency room for discharged patients|one to four hours|||hours||Inter-Quartile Range|Median
838994|NCT01323010|Secondary|Electrocardiogram at Discharge or Hospital Admission|Electrocardiogram at discharge or hospital admission to identify possible rhythm disturbances.|at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment)|No electrocardiographic abnormalities were detected in both groups.||participants with ECG abnormalities|||Number
838995|NCT01323010|Secondary|Electrocardiogram One Hour Post-treatment.|Electrocardiogram one hour post-treatment to identify possible rhythm disturbances.|One hour post-treatment|No electrocardiographic abnormalities were detected im both groups||participants with ECG abnormalities|||Number
838996|NCT01323010|Secondary|Changes in Heart Rate at Discharge or Hospital Admission|Changes in heart rate at discharge or hospital admission (up to 4 hours post treatment) in comparison with baseline.|at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment)|||beats per minute||Standard Error|Mean
838997|NCT01323010|Secondary|Changes in Heart Rate After One Hour|Change in heart rate one hour post-treatment in comparison with baseline.|One hour post-treatment in comparison with baseline|||beats per minute||Standard Error|Mean
838998|NCT01323010|Secondary|Changes in Pulse Oximetry at Discharge or Hospital Admission.|Changes in pulse oximetry at discharge or hospital admission (up to 4 hours post treatment) in comparison with baseline.|at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) in comparison with baseline.|||percentage of oxygen saturation||Standard Deviation|Mean
838999|NCT01323010|Secondary|Change in Pulse Oximetry One Hour Post-treatment|Change in pulse oximetry one hour post-treatment in comparison with baseline|One hour post-treatment in comparison with baseline|||percentage of oxygen saturation||Standard Error|Mean
839001|NCT01323010|Secondary|Changes in Bicarbonate Serum Levels|Changes in bicarbonate serum levels at discharge or hospital admission (up to 4 hours post treatment) in comparison with baseline.|at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) in comparison with baseline.|It was possible to obtain bicarbonate serum levels from 42 patients in the study group and 37 in the control group (in the other samples, this analysis was not feasible due to the long time to transport the samples to the laboratory in one of our centers).||mmol/L||Standard Error|Mean
839002|NCT01323010|Secondary|Changes in Potassium Serum Levels|Changes in potassium serum levels at discharge or hospital admission (up to 4 hours post treatment) in comparison with baseline.|at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) in comparison with baseline.|It was possible to obtain potassium serum levels from 54 patients in the study group and 56 in the control group (in the other samples, this analysis was not feasible due to hemolysis).||mEq/L||Standard Error|Mean
839003|NCT01323010|Secondary|Changes in PRAM Score at Discharge or Hospital Admission|"Change in the Pediatric Respiratory Assessment Measure (PRAM) score at discharge or hospital admission (up to 4 hours post treatment) in comparison with baseline.
The PRAM score is used to assess the severity of asthma attacks, it ranges from 0 to 15, and the higher the score, the greater the severity of the attack.
We calculated the difference between the PRAM score measured at discharge or admission and the PRAM score at baseline (PRAM score discharge or admission - PRAM score baseline).
The larger the absolute value of the difference, the better the outcome (e.g., a difference of -4 indicates a better outcome that a difference of -2).
minimum value of the difference (Albuterol - Higher Dose, experimental group): -9 maximum value of the difference (Albuterol - Higher Dose, experimental group): 0
minimum value of the difference (Albuterol - Lower Dose, control group): -9 maximum value of the difference (Albuterol - Lower Dose, control group): 1"|at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) in comparison with baseline.|||units on a scale||Inter-Quartile Range|Median
839004|NCT01323010|Secondary|Need for Additional Therapies|The need for additional therapies such as magnesium sulphate or intravenous albuterol were recorded|at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment)|no patients received magnesium sulphate or intravenous albuterol in both groups||participants|||Number
839005|NCT01323010|Secondary|Changes in Respiratory Rate After One Hour|Change in respiratory rate one hour post-treatment in comparison with baseline.|One hour post-treatment in comparison with baseline|||breaths per minute||Standard Error|Mean
839006|NCT01323010|Secondary|Electrocardiogram at Baseline|Electrocardiogram performed at baseline|at baseline|no electrocardiopraphic abnormalities were detected in both groups||participants with ECG abnormalities|||Number
839007|NCT01323010|Secondary|Changes in Glucose Serum Levels|Changes in glucose serum levels at discharge or hospital admission (up to 4 hours post treatment) in comparison with baseline.|at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) in comparison with baseline.|It was possible to obtain glucose serum levels from 57 patients in the study group and 55 in the control group (in the other samples, this analysis was not feasible due to hemolysis).||mg/dL||Standard Error|Mean
839008|NCT01323010|Secondary|Albuterol Determination in the Plasma|Albuterol determination in the plasma was carried out at at discharge or hospital admission (up to 4 hours post treatment), dosage was accomplished by High Performance Liquid Chromatography.|at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment)|It was possible to obtain albuterol plasma levels from 52 patients in the study group and 51 in the control group (in the other samples, this analysis was not feasible due to hemolysis).||ng/ml||Inter-Quartile Range|Median
839009|NCT01323010|Secondary|Change in PRAM Score After One Hour|"Change in the Pediatric Respiratory Assessment Measure (PRAM) score one hour post-treatment in comparison with baseline.
The PRAM score is used to assess the severity of asthma attacks, it ranges from 0 to 15, and the higher the score, the greater the severity of the attack.
We calculated the difference between the PRAM score measured one hour post treatment and the PRAM score at baseline (PRAM score 1 hour - PRAM score baseline).
The larger the absolute value of the difference, the better the outcome (e.g., a difference of -4 indicates a better outcome that a difference of -2).
minimum value of the difference (Albuterol - Higher Dose, experimental group): -8 maximum value of the difference (Albuterol - Higher Dose, experimental group): 0
minimum value of the difference (Albuterol - Lower Dose, control group): -8 maximum value of the difference (Albuterol - Lower Dose, control group): 0"|One hour post-treatment|||units on a scale||Inter-Quartile Range|Mean
839010|NCT01323010|Secondary|Forced Expiratory Volume in the First Second|Change in FEV1 one hour post-treatment in comparison with baseline. Spirometry was performed only in subjects older than 6 years and who could perform the maneuver properly.|One hour post-treatment in comparison with baseline|||percentage of predicted||Standard Deviation|Mean
839011|NCT01323010|Primary|Hospital Admission|Hospital admission was defined as the need to stay in the emergency room for more than 4 hours, due to the failure to meet the discharge criteria (PRAM score ≤ 3 and pulse oximetry, ≥ 92%)|Starting at 4 hours post-treatment|||participants|||Number
839012|NCT01323140|Primary|Percent of Subjects With Testosterone Levels in the Normal Range.|Testosterone serum concentration was determined on Day 29/30 and pharmacokinetic (PK) parameters including Cavg and Cmax were calculated for efficacy assessment. Acceptance was defined as at least 75% of subjects with Cavg in the normal range (>= 300 ng/dL to <= 1030 ng/dL), at least 85% of subjects with Cmax <= 1500 ng/dL, no more than 5% of subjects with Cmax between 1800 and 2500 ng/dL, and no subject with Cmax >= 2500 ng/dL.|Day 29/30|||percentage of participants||95% Confidence Interval|Number
839013|NCT01323192|Secondary|Mean Change From Baseline to Endpoint in Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) Total Scores|"Q-LES-Q-SF is a 16-item questionnaire in which each question is rated on a 5-point scale with scores ranging from 1 = very poor to 5 = very good. The total raw score is calculated by summing up the scores for the 16 items. The raw total score is transformed into a percentage maximum possible score using the following formula:(raw total score −minimum score) / (maximum possible raw score −minimum score). The minimum raw score on the Q-LES-Q-SF is 16 (worst), and the maximum score is 80 (best). A higher score indicates a better quality of life."|Baseline (Day 0) to Endpoint (Week 8)|Full analysis set: All participants who received at least 1 dose of study medication; and had baseline and at least 1 post-dose efficacy assessment. One participant in the placebo group was excluded from the full analysis set because no post-dose efficacy data was available.||Scores on a scale||Standard Deviation|Mean
839014|NCT01323192|Secondary|Mean Change From Baseline to Endpoint in the Conners' Adult Attention Deficit-Hyperactivity Disorder (ADHD) Rating Scales–Self Report: Screening Version (CAARS-S:SV) Score|CAARS-S:SV evaluates DSM-IV-oriented inattention, impulsivity and hyperactivity as well as measures of self-concept. The CAARS-S:SV comprises 30 items to measure symptoms for ADHD in adults. Each item is scored from 0 (not at all, never) to 3 (very much, very frequently) with higher scores corresponding to worse symptoms. The total score can range from 0 (best) to 90 (worst). Lower score indicates improvement in ADHD symptoms.|Baseline (Day 0) to Endpoint (Week 8)|Full analysis set: All participants who received at least 1 dose of study medication; and had baseline and at least 1 post-dose efficacy assessment. One participant in the placebo group was excluded from the full analysis set because no post-dose efficacy data was available.||Scores on a scale||Standard Deviation|Mean
839015|NCT01323192|Secondary|Clinical Global Impression of Change (CGI-C) Scores|The CGI-C is a assessment of change in global clinical status, defined as a sense of well-being and ability to function in daily activities. CGI-C scores range from 1 (very much improved) through to 7 (very much worse). Higher scores indicate worsening.|Endpoint (Week 8)|Full analysis set: All participants who received at least 1 dose of study medication; and had baseline and at least 1 post-dose efficacy assessment. One participant in the placebo group was excluded from the full analysis set because no post-dose efficacy data was available.||Scores on a scale||Full Range|Median
839016|NCT01323192|Secondary|Change From Baseline to Endpoint in Clinical Global Impression - Severity (CGI-S) Scores|The CGI-S rating scale is used to rate the severity of a patient's psychotic condition on a 7-point scale. It is rated as follows: 1=Normal, not at all ill, 2=Borderline mentally ill, 3=Mildly ill, 4=Moderately ill, 5=Markedly ill, 6=Severely ill, and 7=Among the most extremely ill. Higher scores indicate worsening.|Baseline (Day 0) to Endpoint (Week 8)|Full analysis set: All participants who received at least 1 dose of study medication; and had baseline and at least 1 post-dose efficacy assessment. One participant in the placebo group was excluded from the full analysis set because no post-dose efficacy data was available.||Scores on a scale||Full Range|Median
839017|NCT01323192|Secondary|Mean Change From Baseline to Endpoint in the Conners' Adult ADHD Rating Scale - Observer Screening Version (CAARS-O: SV) Total Score Other Than Total Attention Deficit-Hyperactivity Disorder (ADHD) Symptoms Score|CAARS-O: SV evaluates DSM-IV-oriented inattention, impulsivity and hyperactivity as well as measures of self-concept. The CAARS-O: SV comprises 30 items to measure symptoms for ADHD in adults. Each item is scored from 0 (not at all, never) to 3 (very much, very frequently) with higher scores corresponding to worse symptoms. The total score can range from 0 (best) to 90 (worst). Lower score indicates improvement in ADHD symptoms.|Baseline (Day 0) to Endpoint (Week 8)|Full analysis set: All participants who received at least 1 dose of study medication; and had baseline and at least 1 post-dose efficacy assessment.||Scores on a scale||Standard Deviation|Mean
839018|NCT01323192|Primary|Change From Baseline to Endpoint in the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Total Attention Deficit-Hyperactivity Disorder (ADHD) Symptoms Scores of Conners' Adult ADHD Rating Scale - Observer Screening Version (CAARS-O: SV)|CAARS-O: SV evaluates DSM-IV-oriented inattention, impulsivity and hyperactivity as well as measures of self-concept. The CAARS-O:SV comprises 30 items to measure symptoms for ADHD in adults. Each item is scored from 0 (not at all, never) to 3 (very much, very frequently) with higher scores corresponding to worse symptoms. The total score can range from 0 (best) to 90 (worst). Lower score indicates improvement in ADHD symptoms.|Baseline (Day 0) to Endpoint (Week 8)|Full analysis set: All participants who received at least 1 dose of study medication; and had baseline and at least 1 post-dose efficacy assessment. One participant in the placebo group was excluded from the full analysis set because no post-dose efficacy data was available.||Scores on a scale||Standard Deviation|Mean
839019|NCT01323270|Primary|Percentage of Participants With at Least One Adverse Event (AE)||Vaccination 1 up to 1 month after Vaccination 3|Summary was performed for participants as per vaccine administration.||percentage of participants|||Number
839020|NCT01323270|Other Pre-specified|Geometric Mean Fold-Rise (GMFR) for IgG||Before Vaccination 1, 1 month after Vaccination 2, 3|A decision was made, a priori, that the hSBA MnB immunogenicity assay will be used instead of the IgG assay originally planned . Therefore only hSBA assay results will be disclosed.|||||
839021|NCT01323270|Other Pre-specified|Immunoglobulin G (IgG) Measured by Geometric Mean Titer (GMT)||Before vaccination 1, 1 month after Vaccination 2, 3|A decision was made, a priori, that the hSBA MnB immunogenicity assay will be used instead of the IgG assay originally planned . Therefore only hSBA assay results will be disclosed.|||||
839022|NCT01323270|Secondary|Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal to (>=) Prespecified Titer Level||1 month after Vaccination 3|||percentage of participants|||Number
839023|NCT01323270|Secondary|Geometric Mean Titer (GMT) for Poliomyelitis Antigens||1 month after Vaccination 1|||titer||95% Confidence Interval|Geometric Mean
839024|NCT01323270|Secondary|GMC for Acellular Pertussis Antigens|Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EU/mL)|1 month after Vaccination 1|||EU/mL||95% Confidence Interval|Geometric Mean
839025|NCT01323270|Secondary|Geometric Mean Concentration (GMC) for Diphtheria and Tetanus Antigens||1 month after Vaccination 1|||International Units per milliliter||95% Confidence Interval|Geometric Mean
839026|NCT01323270|Primary|Percentage of Participants Achieving Prespecified Criteria for the Concomitant Antigen||1 month after Vaccination 1|||percentage of participants|||Number
839035|NCT01323478|Secondary|Risk of Suicidality Using C-SSRS Scores|The Columbia-Suicide Severity Rating Scale (C-SSRS) was developed by researchers at Columbia University as a tool to systematically assess suicidal ideation and behaviour in patients during participation in a clinical study. The C-SSRS is composed of questions that address suicidal behaviour and questions that address suicidal ideation, with subquestions that assess severity. The tool was administered via an interview with the patient. Different versions of the C-SSRS are available. In this study, the Since Last Visit Version was used at all visits. In order to assess the potential relationship between Vortioxetine and suicidality more accurately and systematically, C-SSRS data were collected during the Entire Study Period.|Up to 52 weeks|Suicidal Ideation and Behaviour Based on C-SSRS Scores by Columbia Classification Algorithm for Suicide Assessment (C-CASA) - APTS||participants|||Number
839036|NCT01323478|Secondary|ASEX Total Score After 52 Weeks of Treatment|"The Arizona Sexual Experience Scale (ASEX) is a 5-item, patient selfrated scale that evaluates a patient's recent sexual experience. Patients are asked to assess their own experience over the last week (for example, How strong is your sex drive?, Are your orgasms satisfying?) and respond on a 6-point scale for each item. The ASEX is used to identify individuals with sexual dysfunction. Possible total score ranges from 5 to 30, with the higher score indicating more patient sexual dysfunction."|Week 52|APTS, OC||units on a scale||Standard Error|Mean
839037|NCT01323478|Secondary|SDS Total Score After 52 Weeks of Treatment|The Sheehan Disability Scale (SDS) comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). The higher the score, the more severe.|Week 52|FAS, OC||units on a scale||Standard Deviation|Mean
839038|NCT01323478|Secondary|Proportion of Remitters at Week 52 (Remission Defined as a MADRS Total Score <=10)||Baseline and Week 52|FAS, OC||percentage of patients|||Number
839039|NCT01323478|Secondary|Proportion of Responders at Week 52 (Response Defined as a >=50% Decrease in MADRS Total Score)||Baseline from lead-in study 13267A (NCT01140906) and Week 52|FAS, OC||percentage of patients|||Number
839040|NCT01323478|Secondary|Change From Baseline in HAM-A Total Score After 52 Weeks of Treatment|The Hamilton Anxiety Rating Scale (HAM-A) consists of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behaviour at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic, and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total score from 0 to 56. The higher the score, the more severe.|Baseline and Week 52|FAS, OC||units on a scale||Standard Deviation|Mean
839041|NCT01323478|Secondary|Change From Baseline in CGI-S Score After 52 Weeks of Treatment|The Clinical Global Impression - Severity of Illness (CGI-S) is a 7-point scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The investigator should use his/her total clinical experience with this patient population to judge how mentally ill the patient is at the time of rating.|Baseline and Week 52|FAS, OC||units on a scale||Standard Deviation|Mean
839042|NCT01323478|Secondary|Change From Baseline in MADRS Total Score After 52 Weeks of Treatment|The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe.|Baseline and Week 52|full-analysis set (FAS), observed cases (OC)||units on a scale||Standard Deviation|Mean
839043|NCT01323478|Primary|Percentage of Patients Who Withdrew Due to Intolerance to Treatment||Baseline to Week 52|APTS||percentage of patients|||Number
839044|NCT01323478|Primary|Number of Patients With Adverse Events (AEs)||Baseline to end of the 4-week safety follow-up period|all-patients-treated set (APTS)||participants|||Number
839045|NCT01323582|Secondary|Does GCSI Score Improve (Lower) on Treatment, Pooling the AZ Patients Over Their Treatment Periods? Endpoint is Difference in Post-test Less Baseline|"This is a Validated instrument for measuring symptom severity in patients with gastroparesis. This scoring is based on a Likert Scale from (0-5) with zero being no symptom and five being very severe symptoms on 9 subscales, making the overall score range from 0-45. The higher the score, the more severe patient’s symptoms are. The scale is reported in the references.
This is a calculation taken with GCSI score at end of treatment minus baseline. Negative value reflects this change."|Baseline and end of treatment period|||units on a scale||Standard Deviation|Median
839046|NCT01323582|Secondary|Gastroparesis Cardinal Symptom Index (GCSI) Score Change From Baseline to Post Treatment|"This is a Validated instrument for measuring symptom severity in patients with gastroparesis. This scoring is based on a Likert Scale from (0-5) with zero being no symptom and five being very severe symptoms on 9 subscales, making the overall score range from 0-45. The higher the score, the more severe patient’s symptoms are. The scale is reported in the references. The change was calculated by measuring the end of treatment minus baseline GCSI score.
Negative value reflects this change."|Baseline and end of treatment period|One subject did not complete this part of analysis.||units on a scale||Standard Deviation|Mean
839047|NCT01323582|Secondary|Change in Time to 50% Emptying: Post Test Less Baseline Pooled Over Orderings|Patients will be given a standardized meal enriched with a labeled material and the breath samples are then collected and analyzed. The estimated time to reaching 50% of the accumulated contents is recorded.|at baseline before initiation of the treatment and after completion of each treatment period.|||minutes||Standard Deviation|Mean
839048|NCT01323582|Secondary|Change in Time to 50% Gastric Emptying: Post Test Less Baseline Pooled Over Orderings|Patients will be given a standardized meal enriched with a labeled material and the breath samples are then collected and analyzed. The estimated time to reaching 50% of the accumulated contents is recorded.|Baseline and end of treatment period|||Minutes||Standard Deviation|Mean
839049|NCT01323582|Secondary|TLAG (Time From Ingestion of Meal to Start of Gastric Emptying)|This is defined as the time from ingestion of the meal to the beginning of the emptying process in minutes. Because the difference is RX-B -RX A in one group and RX A -RX B in the other, the difference between these two estimates twice the effect size. Hence the Half is applied, as is standard in the two sample method for crossover studies.|Weeks 4 and 11 (end of periods)|||Minutes||Standard Deviation|Mean
839050|NCT01323582|Secondary|NDI Score|"Nepean Dyspepsia Index (NDI) is a measure of symptom status and quality of life in functional dyspepsia. This scale is scored using each subscale (Tension, interference with daily activities), Eating/drinking, Knowledge/control, work/study) and adding up the items for each of the five subscale score (2-10). Total score range would be 10-50).
For the NDI, a lower number is better meaning the symptom is not effecting quality of life and a higher score closer to 50 is worse meaning it is effecting patients quality of life.
Reference: Talley NJ, Verlinden M, Jones M. Quality of life in functional dyspepsia: responsiveness of the Nepean Dyspepsia Index and developement of a new 10-iten short form. Aliment Pharmacol Ther 2001: 15: 207-216.
Because the difference is RX-B -RX A in one group and RX A -RX B in the other, the difference between these two estimates twice the effect size. Hence the Half is applied, as is standard in the two sample method for crossover studies."|Weeks 4 and 11 (end of periods)|||units on a scale||Standard Deviation|Median
839051|NCT01323582|Primary|Gastroparesis Cardinal Symptom Index (GCSI) Score|"This is a Validated instrument for measuring symptom severity in patients with gastroparesis. This scoring is based on a Likert Scale from (0-5) with zero being no symptoms and five being very severe symptoms on 9 subscales, making the overall score range from 0-45. The higher the score, the more severe patient’s symptoms.
Reference for GCSI: Revicki DA, REntz AM, Dubois D, et al. Development and validation of a patient-assessed gastroparesis symptoms severity measure: the Gastroparesis Cardinal Symptom Index. Ailment Pharm Ther 2003; 18: 141:50.
Because the difference is RX-B -RX A in one group and RX A -RX B in the other, the difference between these two estimates twice the effect size. Hence the Half is applied, as is standard in the two sample method for crossover studies."|Weeks 4 and 11 (end of periods)|One subject did not complete this part of analysis.||units on a scale||Standard Deviation|Mean
839052|NCT01323582|Primary|Time in Minutes for 50% of the Ingested Meal to Empty the Stomach With a Standardized Breath Test: Half the of the Week 11 Value (Period 2) Less Half the of the Week 4 Value (Period 1). This Estimates the Effect Size.|Patients will be given a standardized meal enriched with a labeled material and the breath samples are then collected and analyzed. The estimated time to empty 50% (t 1/2) of the accumulated contents is recorded. Because the difference is RX-B -RX A in one group and RX A -RX B in the other, the difference between these two estimates twice the effect size. Hence the Half is applied, as is standard in the two sample method for crossover studies.|Weeks 4 and 11 (end of periods)|||Minutes||Standard Deviation|Mean
839053|NCT01323595|Secondary|Bleeding Complications|We will record whether there are any bleeding complications associated with treatment after surgery.|7 days after surgery||||||
839054|NCT01323595|Primary|Level of Pain|Patients will rate their pain for 7 days after surgery using an 11-point visual analog scale (0= no pain, 10=worst pain ever). Patients are asked to rate their pain up to four times a day during the post-operative period. Pain scores from each post-operative day each day will be averaged and reported as the pain score for that day.|1 week after surgery|||Analog pain scale||Standard Deviation|Mean
839055|NCT01323621|Secondary|Time to Onset on Treatment Day 1|Time to onset on Treatment Day 1 is defined as the time to an increase of 100 milliliters (mL) from Baseline in FEV1. Time to onset was calculated over 0 to 4 hours (5 min, 15 min, 30 min, 60 min, 120 min, and 240 min) post-dose.|Baseline and Day 1|ITT Population||Minutes||Full Range|Median
839056|NCT01323621|Primary|Change From Baseline Trough in 24-Hour Weighted Mean FEV1 on Treatment Day 84|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled in one second. The weighted mean was calculated from the pre-dose FEV1 and the post-dose FEV1 measurements at 5, 15, 30, and 60 minutes (min) and 2, 4, 6, 8, 12, 13, 14, 16, 20, and 24 hours post-dose on Treatment Day 84. Baseline trough FEV1 was calculated as the mean of the two assessments made 30 and 5 minutes pre-dose on Treatment Day 1. Change from Baseline was calculated as the average of the Day 84 values minus the Baseline value. Analysis of covariance (ANCOVA) was conducted with covariates for country, smoking status, reversibility, and Baseline FEV1.|Baseline (Day 1) and Day 84|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study drug. Only those participants available at the indicated time points were assessed.||Liters||Standard Error|Least Squares Mean
839057|NCT01323634|Secondary|Time to Onset on Treatment Day 1|Time to onset on Treatment Day 1 is defined as the time to an increase of 100 milliliters (mL) from Baseline in FEV1. Time of onset was calculated over 0 to 4 hours (5 min, 30 min, 60 min, 120 min, and 240 min) post-dose.|Day 1|ITT Population. Only participants available at the indicated time point were assessed.||Minutes||Full Range|Median
839058|NCT01323634|Primary|Change From Baseline Trough in 24-hour Weighted-mean FEV1 on Treatment Day 84|Pulmonary function was measured by forced expiratory volume in one second (FEV1). The weighted mean was calculated from the pre-dose FEV1 and the post-dose FEV1 measurements at 5, 15, 30, and 60 minutes (min) and 2, 4, 6, 8, 12, 13, 14, 16, 20, and 24 hours on Treatment Day 84. Baseline trough FEV1 was the mean of the two assessments made 30 and 5 minutes pre-dose on Treatment Day 1. Change from Baseline was calculated as the average of the Day 84 values minus the Baseline value.|Baseline (Day 1) and Day 84|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study drug. Only participants available at the indicated time point were assessed.||Liters||Standard Error|Least Squares Mean
839059|NCT01323647|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.|During the entire study period (Day 0 to Month 01).|The Total Cohort, including all subjects enrolled in the study.||Subjects|||Number
839060|NCT01323647|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Event (AE)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. This outcome measure concerns subjects in the Poliorix Group only.|Within the 31-day follow-up period after the Poliorix™ booster vaccination.|The Total Vaccinated cohort will include all subjects, with booster dose administration documented and for whom data are available.||Subjects|||Number
839061|NCT01323647|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed include drowsiness, irritability, loss of appetite and fever (defined as axillary temperature ≥37.0°C). Any was defined as incidence of the specified symptoms regardless of intensity or relationship to study vaccine. Grade 3 drowsiness was defined as drowsiness that prevents normal activities. Grade 3 fever was defined as fever (axillary temperature) >39.0°C. Grade 3 irritability was defined as crying more than usual/ interferes with normal activities. Grade 3 loss of appetite was defined as not eating at all. Related = symptom assessed by the investigator as related to the vaccination. This outcome measure concerns subjects only in the Poliorix Group.|Within 4-days (Days 0-3) post Poliorix™ booster vaccination.|The Total Vaccinated cohort will include all subjects, with booster dose administration documented and for whom data are available.||Subjects|||Number
839062|NCT01323647|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 pain = Cry when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site. This outcome measure concerns subjects in the Poliorix Group only.|Within 4-days (Days 0-3) post Poliorix™ booster vaccination.|The Total Vaccinated cohort will include all subjects, with booster dose administration documented and for whom data are available.||Subjects|||Number
839063|NCT01323647|Primary|Antibody Titres Against Poliovirus Type 1, 2 and 3.|Antibody titers were summarized by geometric mean titers (GMTs) with their 95% CIs.|Before booster vaccination.|The ATP cohort for antibody persistence included all subjects who completed their full 3-dose primary vaccination course in the primary study and who have not received an additional dose of IPV vaccine since the primary study.Those who had no history of poliovirus infection,and for whom serological results are available at the persistence timepoint||Titres||95% Confidence Interval|Geometric Mean
839064|NCT01323647|Primary|Antibody Titres Against Poliovirus Type 1, 2 and 3|Antibody titers were summarized by geometric mean titers (GMTs) with their 95% CIs. This outcome measure concerns subjects in the Poliorix Group only.|One month after Poliorix™ booster vaccination.|The ATP cohort for immunogenicity included all evaluable subjects who did not receive a product or present a medical condition leading to exclusion from an ATP analysis as listed in protocol and for whom data concerning immunogenicity outcome variables were available.||Titres||95% Confidence Interval|Geometric Mean
839065|NCT01323647|Primary|Number of Subjects Seroprotected for Poliovirus Types 1, 2 and 3 Antibodies Above the Cut-off Value|A seroprotected subject was defined as a vaccinated subject whose antibody titer is greater than or equal to (≥) 8 ED50.|Before booster vaccination.|The ATP cohort for immunogenicity included all evaluable subjects who did not receive a product or present a medical condition leading to exclusion from an ATP analysis as listed in protocol and for whom data concerning immunogenicity outcome variables were available.||Subjects|||Number
839066|NCT01323647|Primary|Number of Subjects Seroprotected for Poliovirus Types 1, 2 and 3 Antibodies Above the Cut-off Value|A seroprotected subject was defined as a vaccinated subject whose antibody titer is greater than or equal to (≥) 8 ED50. This outcome measure concerns subjects in the Poliorix Group only.|One month after Poliorix™ booster vaccination.|The ATP cohort for immunogenicity included all evaluable subjects who did not receive a product or present a medical condition leading to exclusion from an ATP analysis as listed in protocol and for whom data concerning immunogenicity outcome variables were available.||Subjects|||Number
839067|NCT01323660|Secondary|Change From Baseline in 3-hours Post-dose FEV1 at Week 12 of Each Treatment Period|FEVI is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Baseline is the FEV1 value recorded pre-dose on Day 1 of each treatment period, mean Baseline is the mean of the Baselines for each participant, and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Clinic visit post-dose FEV1 at Week 12 (Treatment Day 85) is defined as the FEV1 value obtained 3 hours after dosing on Treatment Day 85. Analysis performed using a repeated measures model with covariates of period Baseline, mean Baseline, period, treatment, visit, smoking status, center group, visit by period Baseline, visit by mean Baseline and visit by treatment interactions 3 hour post-dose FEV1 measurements were taken electronically by spirometry on Day 2, Week 6 and Week 12.|Week 12 of each treatment period (up to Study Week 30)|Intent-to-Treat (ITT) population: all par. randomized to treatment who received at least one dose of study drug in either treatment period. Number of par. represent those with data available at the time point; however, all par. in the ITT population without missing covariate information and with at least one post Baseline measurement are included.||Liters||Standard Error|Least Squares Mean
839068|NCT01323660|Secondary|Change From Baseline in Residual Volume (Trough and 3-hours Post-dose) at Week 12 of Each Treatment Period|Residual Volume (RV) is defined as the air that remains in the lungs after breathing out as fully as possible. Baseline is the RV value recorded pre-dose on Day 1 of each treatment period, mean Baseline is the mean of the Baselines for each participant, and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Trough RV is measured pre-dose on Treatment Week 12. RV 3-hours post-dose is measured from the value obtained 3 hours after dosing on Treatment Week 12. Analysis performed using a repeated measures model with covariates of period Baseline, mean Baseline, period, treatment, visit, smoking status, center group, visit by period Baseline, visit by mean Baseline and visit by treatment interactions. RV measurements were taken electronically by plethysmography on Day 2, Week 6 and Week 1.|Week 12 of each treatment period (up to Study Week 30)|Intent-to-Treat (ITT) population: all par. randomized to treatment who received at least one dose of study drug in either treatment period. Number of par. represent those with data available at the time point; however, all par. in the ITT population without missing covariate information and with at least one post Baseline measurement are included.||Liters||Standard Error|Least Squares Mean
839069|NCT01323660|Secondary|Change From Baseline in Functional Residual Capacity (Trough and 3-hours Post-dose) at Week 12 of Each Treatment Period|Functional Residual Capacity (FRC) is defined as the amount of air still left in the lungs after breathing out normally. Baseline is the FRC value recorded pre-dose on Day 1 of each treatment period, mean Baseline is the mean of the Baselines for each participant, and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Trough FRC is measured pre-dose on Treatment Week 12. FRC 3-hours post-dose is measured from the value obtained 3 hours after dosing on Treatment Week 12. Analysis performed using a repeated measures model with covariates of period Baseline, mean Baseline, period, treatment, visit, smoking status, center group, visit by period Baseline, visit by mean Baseline and visit by treatment interactions. FRC measurements were taken electronically by plethysmography on Day 2, Week 6 and Week 12.|Week 12 of each treatment period (up to Study Week 30)|Intent-to-Treat (ITT) population: all par. randomized to treatment who received at least one dose of study drug in either treatment period. Number of par. represent those with data available at the time point; however, all par. in the ITT population without missing covariate information and with at least one post Baseline measurement are included.||Liters||Standard Error|Least Squares Mean
839070|NCT01323660|Secondary|Change From Baseline in Inspiratory Capacity (Trough and 3-hours Post-dose) at Week 12 of Each Treatment Period|Inspiratory capacity (IC) is defined as the maximum amount of air that can be inhaled into the lungs from the normal resting position after breathing out normally. Baseline is the IC value recorded pre-dose on Day 1 of each treatment period, mean Baseline is the mean of the Baselines for each participant, and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Trough IC is measured pre-dose on Treatment Week 12 of each treatment period. IC 3-hours post-dose is measured from the value obtained 3 hours after dosing on Treatment Week 12 of each treatment period. Analysis performed using a repeated measures model with covariates of period Baseline, mean Baseline, period, treatment, visit, smoking status, center group, visit by period Baseline, visit by mean Baseline and visit by treatment interactions. IC measurements were taken electronically by plethysmography on Day 2, Week 6 and Week 12.|Week 12 of each treatment period (up to Study Week 30)|Intent-to-Treat (ITT) population: all par. randomized to treatment who received at least one dose of study drug in either treatment period. Number of par. represent those with data available at the time point; however, all par. in the ITT population without missing covariate information and with at least one post Baseline measurement are included.||Liters||Standard Error|Least Squares Mean
839071|NCT01323660|Primary|Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Week 12 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 measurements were taken electronically by spirometry on Day 2, Week 6 and Week 12. Baseline is the FEV1 value recorded pre-dose on Day 1 of each treatment period, mean Baseline is the mean of the Baselines for each participant, and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Clinic visit trough (pre-bronchodilator and pre-dose) FEV1 at Week 12 (Treatment Day 85) is defined as the FEV1 value obtained 24 hours after dosing on Treatment Day 84. Analysis performed using a repeated measures model with covariates of period Baseline, mean Baseline, period, treatment, visit, smoking status, center group, visit by period Baseline, visit by mean Baseline and visit by treatment interactions.|Week 12 of each treatment period (up to Study Week 30)|Intent-to-Treat (ITT) Population: all par. randomized to treatment who received at least one dose of study drug in either treatment period. Number of par. represent those with data available at the time point; however, all par. in the ITT population without missing covariate information and with at least one post Baseline measurement are included.||Liters||Standard Error|Least Squares Mean
839072|NCT01323660|Primary|Change From Baseline in Exercise Endurance Time Post-dose at Week 12 of Each Treatment Period|Exercise endurance time (EET) post-dose at Week 12 is defined as the EET obtained 3 hours after dosing at Week 12. EET was measured using the externally paced field walking test called the endurance shuttle walk test (ESWT). Analysis performed using a repeated measures model with covariates of period walking speed, mean walking speed, period, treatment, visit, smoking status, center group, visit by period walking speed, visit by mean walking speed and visit by treatment interactions. The model used all available 3-hour post-dose change from baseline EET values recorded on Day 2, Week 6 and Week 12. Baseline was the EET assessment obtained prior to dosing on Day 1 of each period. The mean walking speed for each participant is the mean of the levels used for the ESWT in each of the two treatment periods. The period walking speed for each participant and treatment period is the difference between the level for that participant and period and the mean walking speed for that participant.|Week 12 of each treatment period (up to Study Week 30)|Intent-to-Treat (ITT) Population: all par. randomized to treatment who received at least one dose of study drug in either treatment period. Number of par. represent those with data available at the time point; however, all par. in the ITT population without missing covariate information and with at least one post Baseline measurement are included.||Seconds||Standard Error|Least Squares Mean
839091|NCT01323790|Secondary|Time (in Hours) to First Post-dose Laxation Without the Use of Rescue Laxatives Within the Previous 24 Hours||12 weeks|The ITT analysis set included all randomized patients, with the exception of patients who were found to have randomized multiple times within the program at different centers.||Hours||95% Confidence Interval|Median
839073|NCT01323673|Secondary|Percent Change From Baseline in Pruritus, Stinging, Burning, and Pain Scores (Target Hand) at Days 3, 8, and 15|On Days 1, 3, 8, and 15, participants assessed the pruritis (itching), stinging (piercing pain), burning, and pain of the target hand. Participants were instructed to assess the level/severity of the indicated symptoms over the previous 24 hours using a scale ranging from 0 (none) to 10 (unbearable). Percent change from baseline was calculated as value at Days 3, 8, and 15 minus the value at Baseline divided by the Baseline value * 100.|Baseline (Day 1) and Days 3, 8, and 15|ITT Population. Only those participants contributing data at the indicated time points were analyzed.||Percent change in scores on a scale||Standard Deviation|Mean
839074|NCT01323673|Secondary|Number of Participants With an SGA (Target Hand) Score of 0 or 1 at Days 3, 8, and 15|On Days 1, 3, 8, and 15 prior to the investigator assessment, participants rated chronic hand dermatitis of the target hand using the 5-point SGA: 0=skin is clear; 1=dermatitis in minimal, there may be a few light-pink areas; 2=dermatitis is mild, there may be occasional light-pink areas; 3=dermatitis is moderate, there may be easily noticeable pink-red areas; 4=dermatitis is severe, there may be deep or bright-red areas that may be warm to the touch.|Days 3, 8, and 15|ITT Population. Missing values were imputed using LOCF (i.e., the last available observation, including Baseline, for a participant was used to estimate subsequent missing data points).||participants|||Number
839075|NCT01323673|Secondary|Number of Participants With an Improvement of at Least 1 Grade in the Subject Global Assessment (SGA) (Target Hand) Score From Baseline to Days 3, 8, and 15|On Days 1, 3, 8, and 15 prior to the investigator assessment, participants rated chronic hand dermatitis of the target hand using the 5-point SGA: 0=skin is clear; 1=dermatitis in minimal, there may be a few light-pink areas; 2=dermatitis is mild, there may be occasional light-pink areas; 3=dermatitis is moderate, there may be easily noticeable pink-red areas; 4=dermatitis is severe, there may be deep or bright-red areas that may be warm to the touch.|Baseline (Day 1) and Days 3, 8, and 15|ITT Population. Missing values were imputed using LOCF (i.e., the last available observation, including Baseline, for a participant was used to estimate subsequent missing data points).||participants|||Number
839076|NCT01323673|Secondary|Number of Participants With an ISGA (Target Hand) Score of 0 or 1 at Days 3, 8, and 15|The investigator rated chronic hand dermatitis of the participants' target hand using the 5-point ISGA: 0=clear, minor residual discoloration, no erythema (redness of skin)/induration (skin hardening)/papulation (eruption of small, rounded solid bumps on skin), no oozing/crusting; 1=almost clear, trace faint pink erythema, no induration/papulation and no oozing/crusting; 2=mild, faint pink erythema, mild induration/papulation; 3=moderate, pink-red erythema, moderate induration/papulation, some oozing/crusting; 4=Severe, bright-red erythema, severe induration/papulation, oozing/crusting.|Days 3, 8, and 15|ITT Population. Missing values were imputed using LOCF (i.e., the last available observation, including Baseline, for a participant was used to estimate subsequent missing data points).||participants|||Number
839077|NCT01323673|Secondary|Number of Participants With an Improvement of at Least 1 Grade in the ISGA (Target Hand) Score From Baseline to Day 3 and and to Day 8|The investigator rated chronic hand dermatitis of the participants' target hand using the 5-point ISGA: 0=clear, minor residual discoloration, no erythema (redness of skin)/induration (skin hardening)/papulation (eruption of small, rounded solid bumps on skin), no oozing/crusting; 1=almost clear, trace faint pink erythema, no induration/papulation and no oozing/crusting; 2=mild, faint pink erythema, mild induration/papulation; 3=moderate, pink-red erythema, moderate induration/papulation, some oozing/crusting; 4=Severe, bright-red erythema, severe induration/papulation, oozing/crusting.|Baseline (Day 1), Day 3, and Day 8|ITT Population. Missing values were imputed using LOCF (i.e., the last available observation, including Baseline, for a participant was used to estimate subsequent missing data points).||participants|||Number
839078|NCT01323673|Secondary|Number of Participants With an Improvement of at Least 2 Grades in the ISGA (Target Hand) Score From Baseline to Day 3 and to Day 8|The investigator rated chronic hand dermatitis of the participants' target hand using the 5-point ISGA: 0=clear, minor residual discoloration, no erythema (redness of skin)/induration (skin hardening)/papulation (eruption of small, rounded solid bumps on skin), no oozing/crusting; 1=almost clear, trace faint pink erythema, no induration/papulation and no oozing/crusting; 2=mild, faint pink erythema, mild induration/papulation; 3=moderate, pink-red erythema, moderate induration/papulation, some oozing/crusting; 4=Severe, bright-red erythema, severe induration/papulation, oozing/crusting.|Baseline (Day 1), Day 3, and Day 8|ITT Population. Missing values were imputed using LOCF (i.e., the last available observation, including Baseline, for a participant was used to estimate subsequent missing data points).||participants|||Number
839079|NCT01323673|Secondary|Number of Participants With an Improvement of at Least 1 Grade in the ISGA (Target Hand) Score From Baseline to Day 15|The investigator rated chronic hand dermatitis of the participants' target hand using the 5-point ISGA: 0=clear, minor residual discoloration, no erythema (redness of skin)/induration (skin hardening)/papulation (eruption of small, rounded solid bumps on skin), no oozing/crusting; 1=almost clear, trace faint pink erythema, no induration/papulation and no oozing/crusting; 2=mild, faint pink erythema, mild induration/papulation; 3=moderate, pink-red erythema, moderate induration/papulation, some oozing/crusting; 4=Severe, bright-red erythema, severe induration/papulation, oozing/crusting.|Baseline (Day 1) and Day 15|ITT Population. Missing values were imputed using LOCF (i.e., the last available observation, including Baseline, for a participant was used to estimate subsequent missing data points).||participants|||Number
839080|NCT01323673|Primary|Number of Participants With Improvement of at Least 2 Grades in the Investigator's Static Global Assessment (ISGA) (Target Hand) Score From Baseline to Day 15|The investigator rated chronic hand dermatitis of the participants' target hand using the 5-point ISGA: 0=clear, minor residual discoloration, no erythema (redness of skin)/induration (skin hardening)/papulation (eruption of small, rounded solid bumps on skin), no oozing/crusting; 1=almost clear, trace faint pink erythema, no induration/papulation and no oozing/crusting; 2=mild, faint pink erythema, mild induration/papulation; 3=moderate, pink-red erythema, moderate induration/papulation, some oozing/crusting; 4=Severe, bright-red erythema, severe induration/papulation, oozing/crusting.|Baseline (Day 1) and Day 15|Intent-to-Treat (ITT) Population: all randomized participants who were dispensed study product. Missing values were imputed using last observation carried forward (LOCF, i.e., the last available observation, including Baseline, for a participant was used to estimate subsequent missing data points).||participants|||Number
839081|NCT01323777|Primary|Monocular Uncorrected Near Decimal VA|VA was tested monocularly unaided at a distance of 40 centimeters (cm) using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.|Day 30-60, Day 120-180, Day 330-420|This analysis population includes all implanted subjects.||participants|||Number
839082|NCT01323777|Primary|Monocular Uncorrected Distance Decimal Visual Acuity|Visual acuity (VA) was tested monocularly (each eye separately) unaided at a distance of 5 meters (m) using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.|Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420|This analysis population includes all implanted subjects.||participants|||Number
839083|NCT01323790|Secondary|Change From Baseline in Patient Assessment of Constipation Quality of Life (PAC-QOL) Satisfaction Domain|The PAC-QOL scale is a 28-item self-report instrument designed to evaluate the burden of constipation on patients’ everyday functioning and well-being in the 2 weeks (14 days) prior to assessment. Each item is rated on a 5-point Likert scale ranging from 0 (not at all) to 4 (extremely). The instrument can be used to generate an overall score, but is also reported to assess 4 specific constipation-related domains including: 1) Worries and concerns (11 items), 2) Physical discomfort (4 items), 3) Psychosocial discomfort (8 items), and 4) Satisfaction (5 items). Each domain score is the mean of the non-missing items for that domain. The total score is the mean of all non-missing items. The range of the domain or total score is 0 (response is 'not at all' for each item) to 4 (response is 'extremely' for each item). A negative change from baseline indicates improvement.|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients who had evaluable data at baseline and post-baseline, with the exception of patients who randomized multiple times at different centers. MMRM analysis includes all patients with baseline and at least 1 post-baseline assessment, while the Ns at Week 12 reflect patients providing data at Week 12.||units on a scale||Standard Error|Least Squares Mean
839084|NCT01323790|Secondary|Change From Baseline in Patient Assessment of Constipation Symptoms Questionnaire (PAC-SYM)|The PAC-SYM questionnaire is a 12-item questionnaire that evaluates the severity of symptoms of constipation in 3 domains (stool, rectal, and abdominal symptoms) on a 5-point Likert scale ranging from 0 (absent) to 4 (very severe) in the 2 weeks (14 days) prior to assessment. Each domain score is the mean of the non-missing items for that domain. The total score is the mean of all non-missing items (ie, symptoms). The range of the domain or total score is 0 (response is 'absent' for each item) to 4 (response is 'very severe' for each item). A negative change from baseline indicates improvement.|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients who had evaluable data at baseline and post-baseline, with the exception of patients who randomized multiple times at different centers. MMRM analysis includes all patients with baseline and at least 1 post-baseline assessment, while the Ns at Week 12 reflect patients providing data at Week 12.||units on a scale||Standard Error|Least Squares Mean
839085|NCT01323790|Secondary|Time (in Hours) to First Post-dose Laxation Without the Use of Rescue Laxatives Within the Previous 24 Hours in the Laxative Inadequate Response (LIR) Subgroup|Time to first post-dose laxation without the use of rescue laxatives within the last 24 hours was calculated in hours as: Date/Time of first post-dose laxation without rescue – First dose date/time.|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients, with the exception of patients who were found to have randomized multiple times within the program at different centers.||hours||95% Confidence Interval|Median
839086|NCT01323790|Secondary|Change From Baseline in Mean Spontaneous Bowel Movements/Week|The number of spontaneous bowel movements/week was determined from the patient's eDiary.|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients who had evaluable data at baseline and post-baseline, with the exception of patients who were found to have randomized multiple times within the program at different centers.||Number of SBMs/week||Standard Error|Least Squares Mean
839087|NCT01323790|Secondary|Change From Baseline in Percent Numbers of Days With a CSBM (Complete Spontaneous Bowel Movement)|A single-item question on the completeness of evacuation, developed and validated through 1:1 interviews with OIC patients, was asked via the eDiary: “Did you feel like your bowels were completely empty after the bowel movement?” Patients provided a yes or a no response. A positive change from baseline indicates improvement.|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients who had evaluable data at baseline and post-baseline, with the exception of patients who were found to have randomized multiple times within the program at different centers.||Percent days/week||Standard Error|Least Squares Mean
839088|NCT01323790|Secondary|Change From Baseline in Stool Consistency (Bristol Stool Scale)|Patients rated stool consistency through completion of the BSS after each BM. The 7 stool types are: 1. Separate hard lumps, like nuts (hard to pass); 2. Sausage-shaped, but lumpy; 3. Like sausage, but with cracks on its surface; 4. Like a sausage or snake, smooth and soft; 5. Soft blobs with clear cut edges (passed easily); 6. Fluffy pieces with ragged edges, a mushy stool; 7. Watery, no solid pieces. A positive change from baseline indicates improvement.|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients who had evaluable data at baseline and post-baseline, with the exception of patients who were found to have randomized multiple times within the program at different centers.||units on a scale||Standard Error|Least Squares Mean
839089|NCT01323790|Secondary|Change From Baseline in Degree of Straining|A single-item straining question was asked via the eDiary: “How much did you strain during your bowel movement?” Patients responded on a 5 point Likert scale: 1=Not at all; 2=A little bit; 3=A moderate amount; 4=A great deal; 5=An extreme amount. A negative change from baseline indicates improvement.|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients who had evaluable data at baseline and post-baseline, with the exception of patients who were found to have randomized multiple times within the program at different centers.||units on a scale||Standard Error|Least Squares Mean
839090|NCT01323790|Secondary|Change From Baseline in Mean Number of Days Per Week With at Least 1 SBM During Weeks 1 to 12||12 weeks|The ITT analysis set included all randomized patients who had evaluable data at baseline and post-baseline, with the exception of patients who were found to have randomized multiple times within the program at different centers.||Number of Days||Standard Error|Least Squares Mean
839092|NCT01323790|Secondary|Response (Responder/Non-responder) to Study Drug in the LIR Subgroup During Weeks 1 to 12|Responder is defined as having at least 3 SBMs/week, with at least 1 SBM/week increase over baseline for at least 9 out of 12 weeks and at least 3 out of the last 4 weeks.|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients, with the exception of patients who were found to have randomized multiple times within the program at different centers. The LIR subgroup used 1 or more laxative classes for at least 4 days in the 2 weeks prior to entry and reported moderate to very severe symptoms.||Number of patients|||Number
839093|NCT01323790|Primary|Response (Responder/Non-responder) to Study Drug During Weeks 1 to 12|Responder was defined as having at least 3 spontaneous bowel movements (SBMs)/week with at least 1 SBM/week increase over baseline for at least 9 out of the 12 treatment weeks and 3 out of the last 4 treatment weeks during the double-blind treatment period. An SBM is a bowel movement occurring 24 hours or more since the last use of rescue medication.|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients, with the exception of patients who were found to have randomized multiple times within the program at different centers.||Number of patients|||Number
839094|NCT01323855|Primary|AUC0-∞ After Single Dosing With Preladenant for Participants With Mild CRI Versus Healthy Matched Controls|Blood samples were taken at the following timepoints: pre-dose, 0.25, 0.50, 0.75, 1, 2, 4, 6, 12, 16, 24, 30, 36 and 48 hours postdose in order to determine the AUC0-∞ of preladenant|Pre-dose to 48 hours post-dose|One participant with mild CRI, and two matched healthy participants with insufficient terminal phase data to allow adequate characterization, were not analyzed. As only participants with mild CRI are presented, participants with severe or moderate CRI or their corresponding healthy matched controls were not analyzed in this outcome measure||ng.hr/mL||95% Confidence Interval|Geometric Mean
839095|NCT01323855|Primary|AUC0-∞ After Single Dosing With Preladenant for Participants With Moderate CRI Versus Healthy Matched Controls|Blood samples were taken at the following timepoints: pre-dose, 0.25, 0.50, 0.75, 1, 2, 4, 6, 12, 16, 24, 30, 36 and 48 hours postdose in order to determine the AUC0-∞ of preladenant|Pre-dose to 48 hours post-dose|One participant with moderate CRI, and two matched healthy participants with insufficient terminal phase data to allow adequate characterization, were not analyzed. As only participants with moderate CRI are presented, participants with mild or severe CRI or their corresponding healthy matched controls were not analyzed in this outcome measure||ng.hr/mL||95% Confidence Interval|Geometric Mean
839096|NCT01323855|Primary|Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞) After Single Dosing With Preladenant for Participants With Severe CRI Versus Healthy Matched Controls|Blood samples were taken at the following timepoints: pre-dose, 0.25, 0.50, 0.75, 1, 2, 4, 6, 12, 16, 24, 30, 36 and 48 hours postdose in order to determine the AUC0-∞ of preladenant|Pre-dose to 48 hours post-dose|Four participants with severe CRI, and two matched healthy participants with insufficient terminal phase data to allow adequate characterization, were not analyzed. As only participants with severe CRI are presented, participants with mild or moderate CRI or their corresponding healthy matched controls were not analyzed in this outcome measure||ng.hr/mL||95% Confidence Interval|Geometric Mean
839097|NCT01323920|Secondary|The Cumulative Incidence of Chronic GVHD Requiring Systemic Immune Suppression up to 1 Year After Stem Cell Infusion||1 year|One participant signed consent and was enrolled onto study, however, was immediately taken off study because it became evident that the participant needed further therapy and was not ready to proceed to transplant.||Percentage of participants|||Number
839098|NCT01323920|Secondary|The Non-relapse Mortality, Progression-free and Overall Survival up to 1 Year After Stem Cell Infusion|Progression free and overall survival by 1 year after stem cell infusion will be assessed using the method of Kaplan and Meier. Progression-free survival will be defined as the time from stem cell infusion to the time of disease progression or death from any cause. Overall survival will be defined as the time from stem cell infusion to the time to death from any cause. Patients will be censored at the time last documented alive. Cumulative incidence and Kaplan-Meier curves will be constructed as appropriate. Progression is defined per clinical presentation, not protocol specified, and vary per disease, e.g. blasts in bone marrow or peripheral blood for AML/MDS; lymphoma + on PET/CT re-staging etc.|1 year|One participant signed consent and was enrolled onto study, however, was immediately taken off study because it became evident that the participant needed further therapy and was not ready to proceed to transplant.||Percent of participants|||Number
839099|NCT01323920|Secondary|The Percentage Donor Engraftment up to Day 30 Post Stem Cell Infusion|To assess the percentage donor engraftment up to day 30 post stem cell infusion, defined as the first of 3 consecutive days tested of documented absolute netrophil count (ANC) >/= 500 cells/u/L|Day 30|One participant signed consent and was enrolled onto study, however, was immediately taken off study because it became evident that the participant needed further therapy and was not ready to proceed to transplant.||Percentage of participants|||Number
839100|NCT01323920|Primary|The Cumulative Incidence of Grade II-IV Acute GVHD up to Day 100 After Stem Cell Infusion|The primary outcome of this study is the cumulative incidence of grade II-IV acute GVHD up to Day 100 after stem cell infusion. Acute GHVD is graded according to the modified Glucksberg criteria (adapted from Thomas et al., NEJM ,1975, pp. 895-90), which is based on criteria by which the provider classifies acute GVHD per its objective organ staging. Acute GVHD is assessed in weekly standard of care visits post stem cell infusion and is captured in the protocol EDC upon evaluation of clinical notes up to Day 100. Data for acute GVHD organ staging and etiologies are collected in an acute GVHD separate case report form and do not include system organ class, expectedness or attribution.|Day 100|One participant signed consent and was enrolled onto study, however, was immediately taken off study because it became evident that the participant needed further therapy and was not ready to proceed to transplant.||Percentage of participants|||Number
839101|NCT01323959|Secondary|Number of Subjects With Serious Adverse Events (SAEs).|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Month 0 – Month 1|The analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of the study booster vaccine, for whom data was available.||Subjects|||Number
839747|NCT01321710|Primary|Maternal Sleep Quantity (Objective)|Maternal sleep quantity is defined as total night-time sleep in hours as measured by wrist actigraphy over 3 nights.|1-month postpartum (approximately)|ITT analysis. Because this was a repeated measures analysis at 1 and 3 months postpartum, subjects missing outcome data at either point were excluded from the analysis.||hours||Standard Deviation|Mean
839102|NCT01323959|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs).|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Day 0–Day 30) follow-up period after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of the study booster vaccine, for whom data was available and the symptom sheet filled in.||Subjects|||Number
839103|NCT01323959|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.|Assessed solicited general symptoms were fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache and gastrointestinal symptoms. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 4-day (Day 0–Day 3) follow-up period after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of the study booster vaccine, for whom data was available and the symptom sheet filled in.||Subjects|||Number
839104|NCT01323959|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.|During the 4-day (Day 0–Day 3) follow-up period after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of the study booster vaccine, for whom data was available.||Subjects|||Number
839105|NCT01323959|Secondary|Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in expressed in ELISA units per millilitre (EL.U/mL)|At Month 1|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
839106|NCT01323959|Secondary|Anti-polio 1, Anti-polio 2 and Anti-polio 3 Antibody Titers|Titers are presented as geometric mean titers (GMTs).|At Month 1|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available.||Titers||95% Confidence Interval|Geometric Mean
839107|NCT01323959|Secondary|Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per millilitre (IU/mL)|At Month 1|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available.||IU/mL||95% Confidence Interval|Geometric Mean
839108|NCT01323959|Secondary|Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Above the Cut-off|Cut-off values assessed were greater than or equal to ≥ 5 Enzyme Linked Immunosorbent Assay (ELISA) units per millilitre (EL.U/ml)|At Month 1|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available.||Subjects|||Number
839109|NCT01323959|Secondary|Number of Subjects With Booster Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), Pertactin (PRN)|Booster response was defined as: for initially seronegative subjects: antibody concentration ≥ 20 EL.U/mL at post booster vaccination; for initially seropositive subjects with pre-vaccination antibody concentration < 20 EL.U/mL: antibody concentration at post booster ≥ 4 fold the pre-vaccination antibody concentration; and for initially seropositive subjects with pre-vaccination antibody concentration ≥ 20 EL.U/mL: antibody concentration at post booster ≥ 2 fold the pre-vaccination antibody concentration.|At Month 1|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available.||Subjects|||Number
839110|NCT01323959|Primary|Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in expressed in ELISA units per millilitre (EL.U/mL)|At Day 0|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
839111|NCT01323959|Primary|Anti-polio 1, Anti-polio 2 and Anti-polio 3 Antibody Titers|Titers are presented as geometric mean titers (GMTs).|At Day 0|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available.||Titers||95% Confidence Interval|Geometric Mean
839123|NCT01323972|Primary|Anti-Circumsporozoite (Anti-CS) Antibody Titers|Antibody titers are presented as geometric mean titers (GMTs) and are measured in titers.|One month post-dose 3 (Month 3)|The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||Titers||95% Confidence Interval|Geometric Mean
839112|NCT01323959|Primary|Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per millilitre (IU/mL)|At Day 0|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available.||IU/mL||95% Confidence Interval|Geometric Mean
839113|NCT01323959|Primary|Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies|Cut-off values assessed were greater than or equal to ≥ 5 Enzyme Linked Immunosorbent Assay (ELISA) units per millilitre (EL.U/ml)|At Day 0|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available.||Subjects|||Number
839114|NCT01323959|Primary|Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3|A seroprotected subject is defined as a vaccinated subject with anti-poliovirus types 1, 2 and 3 antibody concentration greater than or equal to (≥) 8 Effective Dose 50 (ED50)|At Day 0|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available.||Subjects|||Number
839115|NCT01323959|Primary|Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens|A seroprotected subject is defined as a vaccinated subject with anti-D and anti-T antibody concentration greater than or equal to (≥) 0.1 international units per millilitre (IU/mL)|At Day 0|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available.||Subjects|||Number
839116|NCT01323959|Primary|Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3|A seroprotected subject is defined as a vaccinated subject with anti-poliovirus types 1, 2 and 3 antibody concentration greater than or equal to (≥) 8 Effective Dose 50 (ED50)|At Month 1|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available.||Subjects|||Number
839117|NCT01323959|Primary|Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens|A seroprotected subject is defined as a vaccinated subject with anti-D and anti-T antibody concentration greater than or equal to (≥) 0.1 international units per millilitre (IU/mL).|At Month 1|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available.||Subjects|||Number
839118|NCT01323972|Secondary|Number of Subjects With Serious Adverse Events|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Up to 8 months post-dose 1|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Participants|||Count of Participants
839119|NCT01323972|Secondary|Number of Subjects With Unsolicited Adverse Events|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within the 30-day (Days 0-29) post-vaccination period|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Participants|||Count of Participants
839120|NCT01323972|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 loss of appetite = not eating at all. Grade 3 irritability = crying that could not be comforted/prevented normal activity. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 fever = fever higher than (>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|Over a 7-day (Days 0-6) post-vaccination period after each dose and across doses|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with their symptom sheets filled in, for whom data were available.||Participants|||Count of Participants
839121|NCT01323972|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.|Over a 7-day (Days 0-6)post-vaccination period after each dose and across doses|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with their symptom sheets filled in, for whom data were available.||Participants|||Count of Participants
839122|NCT01323972|Secondary|Anti-hepatitis B (Anti-HB) Antibody Concentrations|Antibody concentrations are presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL).|One month post-dose 3 (Month 3)|The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||mIU/mL||95% Confidence Interval|Geometric Mean
839167|NCT01324440|Primary|Geometric Mean Antibody Concentrations (GMC)|Immunoglobulin G (IgG) antibodies were measured by a LUMINEX(TM) assay.|Day 14 postvaccination|The per-protocol analysis excluded patients who had missing baseline and/or postvaccination (Day 14) serology data and patients who developed a S. aureus infection during the 14 days postvaccination.||mcg/mL||95% Confidence Interval|Geometric Mean
839124|NCT01323998|Primary|Number of Participants by Treatment Cohort With and Without a Benign Prostatic Hypertrophy (BPH) Diagnosis|The number of participants treated with alpha-blocker (AB) and 5a lpha reductase inhibitor (5ARI) as monotherapy or in combination reported by the presence or absence of a diagnosis code for BPH (International Classification of Disease, Ninth Revision, Clinical Modification codes: 222.2 and 600.xx). Early combination therapy was defined as the addition of 5ARI to existing AB therapy within 30 days of the initial AB pharmacy claim. Delayed combination therapy was defined as the addition of 5ARI to AB therapy after 30 day but within one year of the initial AB pharmacy claim.|4 years|Males aged 50 and older with a new pharmacy claim for AB, 5ARI or a combination of both. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 milligram, or a procedure code for prostate surgery.||participants|||Number
839125|NCT01324024|Secondary|NYU Paragraph Recall Task|Subjects hear 2 brief narratives, each containing 19-21 informational bits, and are asked to recall as many details as possible immediately after hearing each paragraph (A and B) and again following a 30 minute delay. Subjects receive credit for each informational bit recalled verbatim. Different paragraphs were read at each assessment. The maximum number of correct responses for paragraph A is 19 and the maximum number of correct responses for paragraph B is 21.|Baseline, end of first Intervention (4 weeks) and end of second Intervention (4 weeks)|The numbers in the lisdexamphetamine and placebo arms reflect the fact that 32 subjects completed both arms; 16 participants in each arm. 35 total participant data was analyzed for the baseline arm.||units on a scale||Standard Deviation|Mean
839126|NCT01324024|Secondary|Penn Continuous Performance Test|The Penn Continuous Performance Test is a measure of visual attention and vigilance. In this task, a series of red vertical and horizontal lines flash in a digital numeric frame. The participant must press the spacebar whenever the lines form complete numbers or complete letters. The minimum to maximum score range for this task is 0-60 correct responses, with 60 being a perfect score. This data presented in the outcome measure table reflects the total number of correct responses.|Baseline, end of first Intervention (4 weeks) and end of second Intervention (4 weeks)|The numbers in the lisdexamphetamine and placebo arms reflect the fact that 32 subjects completed both arms; 16 participants in each arm. 35 total participant data was analyzed for the baseline arm.||units on a scale||Standard Deviation|Mean
839127|NCT01324024|Primary|Brown Attention Deficit Disorder Scale (BADDS)|The BADDS questionnaire is a clinician administered questionnaire that assesses the frequency and severity of five clusters of symptoms reflective of executive dysfunction reported by individuals with ADHD. Participants are asked to rate the frequency and severity of a symptom on a scale from 0 to 3, with 0 meaning that the problem described does not relate to them and 3 indicating that the problem is very true for them and occurs almost daily. The range of severity for the total BADDS score is 0 to 120, with scores of 55 and above being consistent with full-syndrome ADHD.|Baseline, end of first Intervention (4 weeks) and end of second Intervention (4 weeks)|Of the 55 participants who were consented for screening, 20 were excluded. Of the remaining 35 subjects, 32 completed both active and placebo treatment trials. The numbers in the lisdexamphetamine and placebo arms reflect the fact that 32 subjects completed both arms. 35 total participant data was analyzed for the baseline arm.||units on a scale||Standard Deviation|Mean
839128|NCT01324102|Primary|Patient-Reported Outcomes Measurement System Scale, a Scale Developed by the National Institute of Health to Assess Outcomes Across Different Trials.|The investigators will use the Patient-Reported Outcomes Measurement System which can be found on the National Institutes of Health website. It measures changes in scale levels of Depression, Anxiety, Fatigue, Sleep Disturbance before and after the intervention. The measure is developed by National Institutes of Health to permit comparison across studies, and is reliable and valid. This is measured at baseline, and to assess for change, after the 8 week yoga intervention. There are six items in each subscale with four points each, with a range from 1-5. The full subscale range is 6-30. Anxiety was assessed by anxiety subscale, ranging from 6 ( no anxiety) to 30 (worst possible anxiety); Insomnia was assessed by the anxiety subscale, ranging from 6 ( no anxiety) to 30 (worst possible anxiety).|Primary outcome is measured at baseline and after the 8 week yoga intervention.|This is a small scale pilot study. Due to small sample size, we did pre-post analysis of the total groups, separated by those with and without initial impairment.||units on a scale||Full Range|Mean
839129|NCT01324128|Secondary|Change in Serum Phosphorus Levels From Baseline to Week 12|Change in serum phosphorus levels from baseline to Week 12 in the PA21 group versus the sevelamer group.|Week 12 post Baseline|For the Secondary Outcome, data from the Per Protocol Set (PPS) was used. The PPS consists of all subjects who had completed the analysis dose titration period (baseline to Week 12), had at least 1 evaluable serum phosphorus result at or after Week 12, and had no major protocol deviations.||mg/dL||Standard Error|Least Squares Mean
839130|NCT01324128|Primary|Change in Serum Phosphorus Levels From Week 24 to Week 27|Change in serum phosphorus levels compared between PA21 Maintenance Dose (MD) and PA21-1 Low Dose (LD) in Stage 2 from Week 24 to Week 27|Week 24, Week 27|For the Primary Outcome, data from the Primary Efficacy Set (PES) was used. The PES consists of subjects who were randomized to Stage 2 and received at least 1 dose of study medication during Stage 2 and had at least 1 post-baseline (Stage 2) efficacy assessment in Stage 2.||mg/dL||Standard Deviation|Least Squares Mean
839131|NCT01324271|Secondary|Number of Retained (TTDS-placed) Tubes|Tube retention is the presence of a TT placed successfully by the TTDS device across the tympanic membrane at the two week follow-up visit. Tube retention was confirmed by physician investigator evaluation. N=74 tubes were successfully placed intraprocedurally. Analysis population includes office/clinical subjects only.|14 days|Total in-office (IO) subjects.||tubes|Participants||Number
839132|NCT01324271|Primary|Percentage of Tubes Successfully Placed Using a TTDS Device|"Device (TTDS) success is defined as the successful delivery of a pre-loaded TT tube across the tympanic membrane using the TTDS. Device success will be evaluated per device attempted. Office/clinical subjects only.
A Device (Type of Unit analyzed) is defined as a TDS attempt. This is not synonymous with “tube.” Tube is the outcome of the device use."|Day 0|All enrolled subjects for which a tympanostomy tube was attempted to be placed using a Tympanostomy Tube Delivery System (TTDS) under local anesthesia in office/clinical setting||percentage of devices|Participants|95% Confidence Interval|Number
839836|NCT01328548|Other Pre-specified|Assessment of Immune Parameters Compatible With Inflammaging: High CD8+CD28CD45RA+T Cells|Characterization of Tcell populations will be conducted on whole blood using multiparametric flow cytometry prior to immunization to characterize the immunological function of circulating Tcells in each participant.|Baseline|Data not collected.|||||
839133|NCT01324271|Primary|Percentage of Subjects With In-office Tube Placement Procedure Success|Procedure Success is defined as the successful placement of any tympanostomy tube in all enrolled ears in a given subject. Procedure Success is determined on a per subject basis: the rate was calculated based on the number of subjects achieving Procedure Success out of the total number of enrolled subjects. Only subjects for whom tubes were placed under local anesthesia were evaluated for Procedure Success.|Day 0|||Percentage of Subjects||95% Confidence Interval|Number
839134|NCT01324310|Secondary|Summary of Participants With Treatment Emergent Adverse Events (TEAEs)|All 15 subjects in the safety population received at least 1 dose of romidepsin. AEs were considered related if assessed by the Investigator as possibly, probably or definitely related to study drug. Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above.|Day 1 up to Day 36 (28 days after last treatment)|The safety population consisted of all participants who received at least 1 dose of study drug. The Day 8 analysis population included 13 participants because two participants discontinued from the study prior to Day 8 (one due to an AE, the other due to disease progression).||participants|||Number
839135|NCT01324310|Primary|Apparent Total Volume of Distribution (Vz)|Vz: apparent total volume of distribution, calculated as [(CL)/λz].|Days 1 and 8, At 0 (predose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion.|Assess the influence of multiple doses of ketoconazole on the PK of romidepsin; the PK population included participants who received at least 1 dose of study drug and had evaluable PK profiles. The reasons for study discontinuation: 1 subject withdrew due to an AE while another subject had disease progression.||Liter||Geometric Coefficient of Variation|Geometric Mean
839136|NCT01324310|Primary|Apparent Total Plasma Clearance (CL)|Apparent total plasma clearance, (CL) calculated as [Dose/AUC 0-∞].|Days 1 and 8; at 0 (pre-dose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion.|Assess the influence of multiple doses of ketoconazole on the PK of romidepsin; the PK population included participants who received at least 1 dose of study drug and had evaluable PK profiles. The reasons for study discontinuation: 1 subject withdrew due to an AE while another subject had disease progression.||L/hr||Geometric Coefficient of Variation|Geometric Mean
839137|NCT01324310|Primary|Estimate of the Terminal Elimination Half-life in Plasma (t1/2)|Terminal elimination half-life (t1/2) in plasma, was calculated as [(ln 2)/λz]|Days 1 and 8; at 0 (pre-dose),1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion.|Assess the influence of multiple doses of ketoconazole on the PK of romidepsin; the PK population included participants who received at least 1 dose of study drug and had evaluable PK profiles. The reasons for study discontinuation: 1 subject withdrew due to an AE while another subject had disease progression.||hours||Geometric Coefficient of Variation|Geometric Mean
839138|NCT01324310|Primary|Time to Maximum Observed Plasma Concentration (Tmax)|Tmax: time to maximum observed Tmax, obtained directly from the observed concentration versus time data|Days 1 and 8; at 0 (pre-dose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion.|Assess the influence of multiple doses of ketoconazole on the PK of romidepsin; the PK population included participants who received at least 1 dose of study drug and had evaluable PK profiles. The reasons for study discontinuation: 1 subject withdrew due to an AE while another subject had disease progression.||hours||90% Confidence Interval|Median
839139|NCT01324310|Primary|Maximum Observed Plasma Concentration (Cmax)|Cmax: maximum observed plasma concentration, obtained directly from the observed concentration versus time data; for Cmax, an analysis of variance (ANOVA) model was used to estimate the ratio of geometric means and its 90% confidence interval (CI) between romidepsin alone and romidepsin in the presence of ketoconazole|Days 1 and 8; at 0 (pre-dose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion.|Assess the influence of multiple doses of ketoconazole on the PK of romidepsin. The PK population included participants who received at least 1 dose of study drug and had evaluable PK profiles. The reasons for study discontinuation: 1 subject withdrew due to an AE while another subject had disease progression.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
839140|NCT01324310|Primary|Area Under the Plasma Concentration Time-curve From Time 0 Extrapolated to Infinity (AUC0-∞)|AUC0-∞: area under the plasma concentration time-curve from Time 0 extrapolated to infinity, calculated as [AUCt + Ct/λz].|Days 1 and 8; at 0 (pre-dose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion.|Assess the influence of multiple doses of ketoconazole on the PK of romidepsin. The PK population included participants who received at least 1 dose of study drug and had evaluable PK profiles. The reasons for study discontinuation: 1 subject withdrew due to an AE while another subject had disease progression.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
839141|NCT01324310|Primary|Area Under the Plasma Concentration Time-curve From Time 0 to 24-hour (AUC 0-24)|AUC 0-24: area under the plasma concentration time-curve from Time 0 to 24 hours, calculated by linear trapezoidal method when concentrations are increasing and the logarithmic trapezoidal method when concentrations are decreasing; for AUC 0-24 an analysis of variance (ANOVA) model was used to estimate the ratio of geometric means and its 90% confidence interval (CI) between romidepsin alone and romidepsin in the presence of ketoconazole|Days 1 and 8; at 0 (predose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion|Assess the influence of multiple doses of ketoconazole on the pharmacokinetic (PK) of romidepsin; the PK population included participants who received at least 1 dose of study drug and had evaluable PK profiles. The reasons for study discontinuation: 1 subject withdrew due to an AE while another subject had disease progression.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
839168|NCT01324440|Primary|Number of Participants With a Positive Immune Response, Defined as a Change in Antibody Level Greater Than or Equal to a 2-fold-rise at Day 14 Compared to Baseline|Immunoglobulin G (IgG) antibodies were measured by a LUMINEX(TM) assay.|Baseline and Day 14 postvaccination|The per-protocol analysis excluded patients who had missing baseline and/or postvaccination (Day 14) serology data and patients who developed a S. aureus infection during the 14 days postvaccination.||participants|||Number
839142|NCT01324310|Primary|Area Under the Plasma Concentration Time-curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-t)of Romidepsin|AUC0-t: area under the plasma concentration time-curve from Time 0 to the time of the last quantifiable concentration (Ct), calculated by linear trapezoidal method when concentrations are increasing and the logarithmic trapezoidal method when concentrations are decreasing. For AUC0-t, an analysis of variance (ANOVA) model was used to estimate the ratio of geometric means and its 90% CI between romidepsin alone and romidepsin in the presence to ketoconazole.|Days 1 and 8; at 0 (pre-dose) 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion.|Assessment on the influence of multiple doses of ketoconazole on the Pharmacokinetic (PK) of romidepsin; the PK population included participants who received at least 1 dose of study drug and had evaluable PK profiles. The reasons for study discontinuation: 1 subject withdrew due to an AE while another subject had disease progression.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
839143|NCT01324323|Secondary|Summary of Participants With Treatment Emergent Adverse Events (TEAEs)|AEs were considered related if assessed by the Investigator as possibly, probably or definitely related to study drug. Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above.|Day 1 up to Day 36 (28 days after the last treatment)|The safety population included all subjects who received at least 1 dose of study drug.||participants|||Number
839144|NCT01324323|Primary|Apparent Total Volume of Distribution (Vz).|Apparent total volume of distribution (Vz) was calculated as [(CL)/λz] for Romidepsin and co-administered with Rifampin.|Days 1 and 8; at 0 (predose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion.|The PK population was to consist of all participants who received at least 1 dose of study drug and had evaluable PK profiles.||Liters||Geometric Coefficient of Variation|Geometric Mean
839145|NCT01324323|Primary|Clearance (CL): Apparent Total Plasma Clearance.|The apparent total plasma clearance (CL) was calculated as [Dose/AUC0-∞] for Romidepsin alone and co-administered with rifampin plasma concentrations.|Days 1 and 8; at 0 (predose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion.|The primary objective was to assess the influence of multiple doses of rifampin on the PK of romidepsin. The PK population included all participants who received at least 1 dose of study drug and had evaluable PK profiles. The primary reason for study discontinuation for the 1 participant was due to withdrawal of consent.||L/hr||Geometric Coefficient of Variation|Geometric Mean
839146|NCT01324323|Primary|Estimate of the Terminal Elimination Half-life in Plasma (t1/2)|The terminal elimination half-life (t1/2) in plasma, was calculated as [(ln 2)/λz]. This was only calculated when a reliable estimate for λz could be obtained.|Days 1 and 8; at 0 (predose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion.|The primary objective was to assess the influence of multiple doses of rifampin on the PK of romidepsin. The PK population included all participants who received at least 1 dose of study drug and had evaluable PK profiles. The primary reason for study discontinuation for the 1 participant was due to withdrawal of consent.||hours||Geometric Coefficient of Variation|Geometric Mean
839147|NCT01324323|Primary|Time to Maximum Observed Plasma Concentration (Tmax)|Time to maximum observed plasma concentration (Tmax) was obtained directly from the observed concentration versus time data.|Days 1 and 8; at 0 (predose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion.|The primary objective was to assess the influence of multiple doses of rifampin on the PK of romidepsin. The PK population included all participants who received at least 1 dose of study drug and had evaluable PK profiles. The primary reason for study discontinuation for the 1 participant was due to withdrawal of consent.||hours||Full Range|Median
839148|NCT01324323|Primary|Maximum Observed Plasma Concentration (Cmax)of Romidepsin|Maximum observed plasma concentration (Cmax)was obtained directly from the observed concentration versus time data.|Days 1 and 8; at 0 (predose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion.|The primary objective was to assess the influence of multiple doses of rifampin on the PK of romidepsin. The PK population included all participants who received at least 1 dose of study drug and had evaluable PK profiles. The primary reason for study discontinuation for the 1 participant was due to withdrawal of consent.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
839149|NCT01324323|Primary|Area Under the Plasma Concentration Time-curve From Time Zero Extrapolated to Infinity (AUC0-∞).|AUC0-∞: area under the plasma concentration time-curve from Time 0 extrapolated to infinity, calculated as [AUCt + Ct/λz]. λz is the apparent terminal rate constant. No AUC extrapolation was performed with unreliable λz. If the percentage of AUC extrapolated is ≥ 25%, AUC0–∞ will not be reported.|Days 1 and 8; at 0 (predose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion.|The primary objective was to assess the influence of multiple doses of rifampin on the PK of romidepsin. The PK population included all participants who received at least 1 dose of study drug and had evaluable PK profiles. The primary reason for study discontinuation for the 1 participant was due to withdrawal of consent.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
839150|NCT01324323|Primary|Area Under the Plasma Concentration Time-curve From Time 0 to 24-hour (AUC0-24) for Romidepsin|Individual and mean romidepsin plasma concentrations by treatment and scheduled time data were collected. AUC0-24: area under the plasma concentration time-curve from Time 0 to 24 hours, calculated by linear trapezoidal method when concentrations are increasing and the logarithmic trapezoidal method when concentrations are decreasing.|Day 1 and Day 8; at 0 (predose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion.|The PK population included all participants who received at least 1 dose of study drug and had evaluable PK profiles. The primary reason for study discontinuation for the 1 participant was due to withdrawal of consent.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
839178|NCT01324622|Secondary|Sensory Deficit||up to 24 months|Due to the study’s early termination, no data were collected for this outcome|||||
839179|NCT01324622|Secondary|Reflex Evaluation||up to 24 months|Due to the study’s early termination, no data were collected for this outcome|||||
839151|NCT01324323|Primary|Area Under the Plasma Concentration Time-curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-t)of Romidepsin|AUC0-t: area under the plasma concentration time-curve from Time 0 to the time of the last quantifiable concentration (Ct), calculated by linear trapezoidal method when concentrations are increasing and the logarithmic trapezoidal method when concentrations are decreasing.|Days 1 and 8; at 0 (pre-dose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion.|The PK population included all participants who received at least 1 dose of study drug and had evaluable PK profiles. The primary reason for study discontinuation for the 1 participant was due to withdrawal of consent.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
839152|NCT01324349|Secondary|Number of Subjects With Treatment-emergent Adverse Events||Up to 30 days post surgery.|All treated subjects are included in the Safety population.||Participants|||Number
839153|NCT01324349|Secondary|Number of Subjects to Achieve Hemostasis Within 3 Minutes of Study Treatment Application|Stopwatches will be provided to document time to hemostasis. Hemostasis will be assessed every 30 seconds until the 5-minute time point, at which point the visual inspection will continue at one-minute intervals up to 10 minutes or until hemostasis is achieved.|Intra-operative (day 1)|Per the study protocol, the ITT population will serve as the primary analysis population for effectiveness and will be discussed in this report. One randomized subject, Subject 1104, did not receive the assigned treatment (TachoSil).||Participants|||Number
839154|NCT01324349|Primary|Median Time to Achieve Hemostasis Following Application of Study Treatment.|Stopwatches will be provided to document time to hemostasis. Hemostasis will be assessed every 30 seconds until the 5-minute time point, at which point the visual inspection will continue at one-minute intervals up to 10 minutes or until hemostasis is achieved.|Intra-operative (day 1)|Per the study protocol, the ITT population will serve as the primary analysis population for effectiveness. One randomized subject, Subject 1104, did not receive the assigned treatment (TachoSil®).||Minutes||Full Range|Median
839155|NCT01324388|Primary|Mean, 24-hour Blood Pressure (Collected by Ambulatory Blood Pressure Monitoring [ABPM]) in Response to Co-administration of LY2189265 and Metoprolol||Day -1, Day 4, Day 7 of Treatment 2 in Part 2|Participants who received at least one dose of study drug (LY2189265 or metoprolol) with evaluable Part 2 ABPM blood pressure data.||millimeter of mercury (mm Hg)||Standard Deviation|Mean
839156|NCT01324388|Primary|Mean, 24-hour Heart Rate (Collected by Ambulatory Blood Pressure Monitoring [ABPM]) in Response to Co-administration of LY2189265 and Metoprolol||Day -1, Day 4, Day 7 of Treatment 2 in Part 2|Participants who received at least one dose of study drug (LY2189265 or metoprolol) with evaluable Part 2 ABPM heart rate data.||beats per minute (bpm)||Standard Deviation|Mean
839157|NCT01324388|Primary|Pharmacokinetics, Maximum Concentration (Cmax) of Lisinopril||Day -1, Day 3, Day 24 in Part 1|Participants who received at least one dose of study drug (LY2189265 or placebo) with evaluable lisinopril Cmax data.||(nanograms per milliliter) per milligram||Geometric Coefficient of Variation|Geometric Mean
839158|NCT01324388|Secondary|Pharmacokinetics, Maximum Concentration (Cmax) of Metoprolol When Administered With LY2189265||Day 4 and Day 7 of Treatment 2 in Part 2|Participants who received at least one dose of study drug (LY2189265 or metoprolol) with evaluable Part 2 metoprolol Cmax data.||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
839159|NCT01324388|Secondary|Pharmacokinetics, Area Under the Concentration Curve (AUC) of Metoprolol When Administered With LY2189265||Day 4 and Day 7 of Treatment 2 in Part 2|Participants who received at least one dose of study drug (LY2189265 or metoprolol) with evaluable Part 2 metoprolol AUC data.||nanograms*hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
839160|NCT01324388|Secondary|Mean, 24-hour Blood Pressure (Collected by Ambulatory Blood Pressure Monitoring [ABPM]) in Response to Co-administration of LY2189265 and Lisinopril||Day -1, Day 3, Day 24 of Part 1|Participants who received at least one dose of study drug (LY2189265 or placebo) with evaluable Part 1 ABPM blood pressure data.||millimeter of mercury (mm Hg)||Standard Deviation|Mean
839161|NCT01324388|Secondary|Mean, 24-hour Heart Rate (Collected by Ambulatory Blood Pressure Monitoring [ABPM]) in Response to Co-administration of LY2189265 and Lisinopril||Day -1, Day 3, Day 24 of Part 1|Participants who received at least one dose of study drug (LY2189265 or placebo) with evaluable Part 1 ABPM heart rate data.||beats per minute (bpm)||Standard Deviation|Mean
839162|NCT01324388|Primary|Pharmacokinetics, Area Under the Concentration Curve (AUC) of Lisinopril||Day -1, Day 3, Day 24 of Part 1|Participants who received at least one dose of study drug (LY2189265 or placebo) with evaluable lisinopril AUC data.||(nanograms*hours/milliliter)/milligram||Geometric Coefficient of Variation|Geometric Mean
839163|NCT01324401|Secondary|Desensitization|The consumption of 5 grams of peanut protein during an open food challenge without objective symptoms immediately post treatment|at least 36 months|||Participants|||Count of Participants
839164|NCT01324401|Primary|Tolerance or Sustained Unresponsiveness|The consumption of 5 grams of peanut protein during a double-blind placebo controlled food challenge without objective symptoms after one month of post treatment avoidance|at least 36 months|||Participants|||Count of Participants
839165|NCT01324440|Primary|Number of Vaccine-related Serious Adverse Experiences|"Investigators were instructed to determine the seriousness and causality (relatedness to test vaccine) of each AE based on criteria defined in the protocol:
A serious adverse event (SAE) is any AE that:
results in death,
is life threatening,
results in a persistent or significant disability/incapacity,
results in or prolongs an existing inpatient hospitalization,
is a congenital anomaly/birth defect,
is a cancer,
is an overdose,
or is another important medical event that may require medical or surgical intervention to prevent one of the outcomes listed above."|Up to Day 360 postvaccination|Any subject who received clinical material and had at least 1 day of safety follow-up was included in the safety summary.||participants|||Number
839166|NCT01324440|Primary|Change in Antibody Concentration (Titer) at Day 14 Compared to Baseline, Expressed as the Geometric Mean Fold-rise (GMFR)|"Immunoglobulin G (IgG) antibodies were measured by a LUMINEX(TM) assay.
The GMFR is the ratio of the antibody concentration at Day 14 to the antibody concentration at baseline."|Baseline and Day 14 postvaccination|The per-protocol analysis excluded patients who had missing baseline and/or postvaccination (Day 14) serology data and patients who developed a S. aureus infection during the 14 days postvaccination.||ratio of IgG titer at Day 14 to baseline||95% Confidence Interval|Geometric Mean
839180|NCT01324622|Secondary|Motor Deficit||up to 24 months|Due to the study’s early termination, no data were collected for this outcome|||||
839169|NCT01324570|Primary|Pharmacokinetics (PK) of Buprenorphine Following Transdermal Administration: Apparent Volume of Distribution (Vc/F)|The population PK (PopPK) of BTDS buprenorphine in pediatric patients ages 7 to 16 years was described by a 2-compartment model with sequential zero- and first-order absorption from the patch. A fixed allometric relationship was used to describe the effects of changes in ideal body weight (IBW) across pediatric patients on all clearance and volume parameters. Given the sparse sample collections, small sample size, and complexity of the absorption process with the patch formulation, this PopPK model was fit to the pediatric data using nonlinear mixed effects modeling (NONMEM) Bayes method with selective use of priors from previous adult PopPK results. Estimates of fixed effects from the final model were used to calculate the Vc/F after patch dosing given the covariate distribution in the PopPK dataset and the typical weights from children in the National Health and Nutrition Examination Survey (NHANES) dataset.|Day 1, end of week 1, days 9/10, end of week 2, and end of week 4 or at discontinuation prior to end of study visit|The full analysis population (FAP) for PK consisted of patients who received study drug and had at least 1 valid quantifiable PK blood sample (N=41).Three patients had no quantifiable plasma buprenorphine concentration measurements and were not included in the PK analysis.The final buprenorphine pediatric PK analysis dataset comprised 38 patients.||Liters||95% Confidence Interval|Mean
839170|NCT01324570|Secondary|Parent/Caregiver-assessed Global Impression of Change (PGIC)|The PGIC rating score variable was collected on a 7-point scale ranging from 1 to 7 (where 1 = very much improved; and 7 = very much worse). The PGIC is designed to assess overall satisfaction with the treatment. The PGIC score was summarized using the number and percent of patients in each of the 7 possible response categories overall and by age group. PGIC was assessed by the parent/caregiver at the end of treatment visit or early discontinuation visit.|End of treatment (week 24) or early discontinuation visit|The full analysis population (FAP) (N=40) was the group of patients who received at least 1 dose of the study drug during the study; however data was provided for only 38 patients for this outcome measure.||Participants|||Count of Participants
839171|NCT01324570|Secondary|Pain Right Now Assessment by Patients Aged 12 to 16 Years, Inclusive|"Pain right now was assessed using a 100-mm visual analogue scale (VAS). The 100-mm VAS is a 100-mm line with 1 end marked as “no pain” and the other marked as “pain as bad as it could be.” The patient was asked to make a mark on that line indicating his or her level of pain. Pain right now score was defined as the distance (in mm) from the “no pain” end to the patient’s mark; 0=no pain and bigger numbers indicate more pain. For screening to week 4, pain right now was assessed 30 minutes before initial BTDS application on day 1; one hour after initial BTDS application on day 1; thereafter, once daily at approximately 8 PM for the first 4 weeks. Baseline was the last assessment prior to the first dose. For weeks 1-4, weekly averages of the pain right now scores were calculated using the sum of all available pain right now scores recorded daily during a given week divided by the number of available scores.
For weeks 6-24, pain right now was measured once a week at approximately 8 PM."|Up to 24 weeks|The FAP was the group of patients who received at least 1 dose of the study drug during the study.||units on a scale||Standard Error|Mean
839172|NCT01324570|Secondary|Pain Right Now Assessment by Patients Aged 7 to 11 Years, Inclusive|"Pain right now was assessed using the Faces of Pain Scale-Revised (FPS-R). The FPS-R is a horizontal row of 6 faces representing pain intensity, with “no hurt” at the far left and “hurts worst” at the far right; the intensities are scored as 0, 2, 4, 6, 8, or 10. A score of 0=no pain, and 10=very much pain. For screening to week 4, pain right now was assessed at 30 minutes before initial BTDS application on day 1; one hour after initial BTDS application on day 1; thereafter, once daily at approximately 8 PM for the first 4 weeks. Baseline score was the last assessment prior to the first dose. For weeks 1-4, weekly averages of the pain right now scores were calculated using the sum of all available pain right now scores recorded daily during a given week divided by the number of available scores.
The study measured pain right now for weeks 6-24 once a week at approximately 8 PM while on treatment; however, no patients in this age group were treated beyond week 12."|Up to 24 weeks|The full analysis population (FAP) was the group of patients who received at least 1 dose of the study drug during the study.||units on a scale||Standard Error|Mean
839173|NCT01324570|Primary|Pharmacokinetics (PK) of Buprenorphine Following Transdermal Administration: Apparent Clearance (CL/F)|The population PK (PopPK) of BTDS buprenorphine in pediatric patients ages 7 to 16 years was described by a 2-compartment model with sequential zero- and first-order absorption from the patch. A fixed allometric relationship was used to describe the effects of changes in ideal body weight (IBW) across pediatric patients on all clearance and volume parameters. Given the sparse sample collections, small sample size, and complexity of the absorption process with the patch formulation, this PopPK model was fit to the pediatric data using nonlinear mixed effects modeling (NONMEM) Bayes method with selective use of priors from previous adult PopPK results. Estimates of fixed effects from the final model were used to calculate the CL/F after patch dosing given the covariate distribution in the PopPK dataset and the typical weights from children in the National Health and Nutrition Examination Survey (NHANES) dataset.|Day 1, end of week 1, days 9/10, end of week 2, and end of week 4 or at discontinuation prior to end of study visit|The full analysis population (FAP) for PK consisted of patients who received study drug and had at least 1 valid quantifiable PK blood sample (N=41).Three patients had no quantifiable plasma buprenorphine concentration measurements and were not included in the PK analysis.The final buprenorphine pediatric PK analysis dataset comprised 38 patients.||Liters/hour||95% Confidence Interval|Mean
839174|NCT01324570|Primary|The Number of Participants With Adverse Events as a Measure of Safety|Safety assessments consisted of reports of AEs, vital signs (blood pressure, pulse rate, respiratory rate, and temperature), weight, hemoglobin-oxygen saturation measured by pulse oximetry (SpO2), clinical laboratory tests, somnolence (assessed by the University of Michigan Sedation Scale [UMSS]), conventional 12-lead electrocardiograms (ECGs), and 24-hour digital 12-lead ECGs (Holter monitor). Safety variables were summarized descriptively within age group for the safety population.|Up to 28 weeks|The safety population (N=41) was the group of patients who received at least 1 dose of study drug during the study.||Participants|||Count of Participants
839175|NCT01324622|Secondary|Extent of Spinal Canal/Cord Decompression||up to 24 months|Due to the study’s early termination, no data were collected for this outcome|||||
839176|NCT01324622|Secondary|Sagittal Canal Diameter||up to 24 months|Due to the study’s early termination, no data were collected for this outcome|||||
839177|NCT01324622|Secondary|Range of Motion||up to 24 months|Due to the study’s early termination, no data were collected for this outcome|||||
839191|NCT01324947|Secondary|Time to Response Based on IMWG and Assessed by the Investigator|Time to Response was calculated as the time from enrollment to the initial response (PR or better) based on IMWG and assessed by the investigator.|From randomization through the follow-up phase; up to the data-cut off of 31 July 2014; Maximum time to response was 23.1 weeks|Includes those who had at least a partial response or better; Intent to Treat||weeks||Full Range|Median
839192|NCT01324947|Secondary|Kaplan-Meier Estimate for Overall Survival|Overall survival was calculated as the time from randomization to death from any cause. Overall survival was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented.|From randomization through the follow-up phase; Maximum time on follow-up was 141.1 weeks.|Intent to Treat population included all participants enrolled into the study||weeks||95% Confidence Interval|Median
839193|NCT01324947|Secondary|Kaplan-Meier Estimate Duration of Response Based on Investigator Assessment Using IMWG Criteria|Duration of Response (calculated for responders only) is defined as the time from the initial documented response (partial response or better) to confirmed disease progression by the investigator based on IMWG criteria.|From randomization through the study follow-up phase; up to the data cut-off of 31 July 2014; Maximum duration of response follow-up was 90.3 weeks.|Includes those who had a partial response or better.||weeks||95% Confidence Interval|Median
839194|NCT01324947|Secondary|Kaplan-Meier Estimate for Time to Progression (TTP) Based on Investigator Assessment Using IMWG Criteria|"Time to progression (TTP) was calculated as the time from randomization to the first documented progression confirmed by the investigator and based on the International Myeloma Working Group Uniform Response criteria (IMWG).
Progressive disease requires 1 of the following:
Increase of ≥ 25% from nadir in:
Serum M-component (absolute increase ≥ 0.5 g/dl)
Urine M-component (absolute increase ≥ 200 mg/24 hours)
In patients without measurable serum and urine M-protein levels the difference between involved and uninvolved free light chain (FLC) levels (absolute increase > 100 mg/dl)
Bone marrow plasma cell percentage (absolute % ≥ 10%)
Development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas.
Development of hypercalcemia (corrected serum calcium > 11.5 mg/dl) attributed solely to plasma cell proliferative disease."|From randomization through the follow-up phase; up to the data-cut off of 31 July 2014; Maximum time to progression follow-up was 90.3 weeks.|Intent to Treat includes all participants enrolled||weeks||95% Confidence Interval|Median
839195|NCT01324947|Secondary|Kaplan Meier Estimates for Progression Free Survival (PFS) by Investigator Based on IMWG|"Progression-free survival was calculated as the time from randomization to disease progression as determined by the Investigator based on the International Myeloma Working Group Uniform Response criteria (IMWG), or death on study, whichever occurred earlier.
Progressive disease requires 1 of the following:
Increase of ≥ 25% from nadir in:
Serum M-component (absolute increase ≥ 0.5 g/dl)
Urine M-component (absolute increase ≥ 200 mg/24 hours)
In patients without measurable serum and urine M-protein levels the difference between involved and uninvolved free light chain (FLC) levels (absolute increase > 100 mg/dl)
Bone marrow plasma cell percentage (absolute % ≥ 10%)
Development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas."|From randomization through the follow-up phase; Maximum duration of follow-up for PFS was 90.3 weeks.|Intent to Treat included all participants enrolled.||weeks||95% Confidence Interval|Median
839196|NCT01324947|Secondary|Number of Participants With Adverse Events and Type of Adverse Events|"An adverse event is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. A serious AE is any AE occurring at any dose that:
Results in death;
Is life-threatening;
Requires or prolongs existing inpatient hospitalization;
Results in persistent or significant disability/incapacity;
Is a congenital anomaly/birth defect;
Constitutes an important medical event.
The Investigator assessed the relationship of each AE to study drug and graded the severity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0):
Grade 1 = Mild (no limitation in activity or intervention required); Grade 2 = Moderate (some limitation in activity; no/minimal medical intervention required);-Grade 3 = Severe (marked limitation in activity; medical intervention required, hospitalization possible); Grade 4 = Life-threatening; Grade 5 = Death"|From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.|Safety population includes all participants who received at least one dose of study drug.||participants|||Number
839197|NCT01324947|Secondary|Percentage of Participants With Objective Response According to European Group for Blood and Marrow Transplantation (EBMT) Criteria Based on Investigator Assessment|"Objective response defined as a best overall response of complete response (CR) or partial response (PR) based on the CR and requires all of the following:
Absence of original monoclonal paraprotein in serum and urine by immunofixation maintained at least 42 days.
<5% plasma cell in bone marrow aspirate and on bone marrow biopsy, if performed.
No increase in size or number of lytic bone lesions.
Disappearance of soft tissue plasmacytomas.
PR requires all of the following:
≥50% reduction in level of serum monoclonal paraprotein, maintained at least 42 days.
Reduction in 24-hour urinary light chain extraction by ≥90% or to <200 mg, maintained at least 42 days.
For patients with non-secretory myeloma, ≥50% reduction in plasma cells in bone marrow aspirate and on biopsy, if performed, for at least 42 days."|From randomization through the study follow-up phase; up to the data cut-off of 31 July 2014; Maximum time on follow-up was 141.1 weeks.|Intent to treat population includes all participants enrolled.||percentage of participants|||Number
839225|NCT01316887|Secondary|Change From Baseline in the Mean Number of Puffs of Rescue Medication (Salbutamol and/or Ipratropium Bromide) Per Day Over the Course of the 52-week Treatment Period|Participants recorded the number of puffs and/or the number of nebules of rescue albuterol/salbutamol and/or ipratropium bromide used in the past 24 hours for the relief of COPD symptoms in the daily diary. The total puffs of rescue medication for each day was calculated as follows: (number of salbutamol puffs + number of ipratropium puffs + [2 * number of salbutamol nebules] + [2 * number of ipratropium nebules]). Baseline is the mean during the week prior to Day 1. Change from Baseline was calculated as the mean number of puffs/day over Weeks 1-52 minus the mean number of puffs/day at Baseline. Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, Baseline (mean during the week prior to Day 1), smoking status, and center group.|Baseline; from the start of study drug up to 52 weeks|ITT Population. Only those participants who had rescue data available on at least 50% of the days in the 52-week treatment period were included in the analysis.||Number of puffs per day||Standard Error|Least Squares Mean
839198|NCT01324947|Primary|Percentage of Participants With an Objective Response According to International Myeloma Working Group (IMWG) Uniform Response Criteria Based on Investigator Assessment|"Objective response defined as a best overall response of stringent complete response (SCR), complete response (CR), very good partial response (VGPR) or partial response (PR) based on Investigator Assessment.
SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; PR: ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. A ≥50% decrease in the difference between involved and uninvolved FLC levels in place of the M-protein criteria or a ≥50% reduction in plasma cells in place of M-protein if baseline was ≥30%. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas."|From randomization through the study follow-up phase; up to the data cut-off of 31 July 2014; Maximum time on follow-up was 141.1 weeks.|Intent to Treat Population was defined as all enrolled participants.||percentage of participants|||Number
839199|NCT01324999|Secondary|Number of Participants With Change in WHO Functional Class (WHO FC)|The WHO functional classification ranges from I (patient's disease does not affect daily activities) to IV (patient's disease causes severe impairment). Higher scores indicate more severe impairment.|Baseline, Week 24|||participants|||Number
839200|NCT01324999|Secondary|St. George's Respiratory Questionnaire (SGRQ) Score|The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life)|Baseline, Week 8, Week 16, Week 24|||units on a scale||Standard Deviation|Mean
839201|NCT01324999|Secondary|Short Form-36 Global Score|SF- 36 investigates the standard of quality of life through a general health assessment and not specific to a particular disease, age or treatment group. It is a 36-item questionnaire measuring 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Each domain score ranges from 0 (worst) to 100 (best), with higher scores reflecting better health-related functional status. The global score is determined by taking an average of the individual domain scores. The global score range is from 0 (worst) to 100 (best).|Baseline, Week 8, Week 16, Week 24|||units on a scale||Standard Deviation|Mean
839202|NCT01324999|Secondary|Brain Natriuretic Peptide Level||Baseline, Week 8, Week 16, Week 24|||pg/mL||Standard Deviation|Mean
839203|NCT01324999|Secondary|Maximum Borg Dyspnea Score During 6 Minute Walk Test|The modified Borg scale consists of a vertical scale labelled 0 to10 with corresponding verbal expressions of progressively increasing sensation (shortness of breath) intensity. 0 represents no dyspnea, and 10 is the highest level of perceived dyspnea.|Baseline, Week 8, Week 16, Week 24|Only 6 of the 7 study completers performed 6 minute walk test through the end of the study.||units on a scale||Standard Deviation|Mean
839204|NCT01324999|Secondary|Oxygen Desaturation During 6 Minute Walk Test|Change (decrease) in oxygen saturation from start of 6 minute walk to nadir during the 6 minute walk test|Baseline, Week 24|Only 6 of the 7 study completers performed the 6 minute walk test through week 24||oxygen saturation percentage points||Standard Deviation|Mean
839205|NCT01324999|Secondary|Resting Oxygen Saturation|Percent oxygen saturation of hemoglobin as measured by pulse oximetry in the resting state.|Baseline, Week 24|only 6 of the 7 study completers performed the 6 minute walk test through week 24.||percent||Standard Deviation|Mean
839206|NCT01324999|Primary|6 Minute Walk Distance||Baseline, Week 8, Week 16, Week 24|Only 6 of the 7 study completers performed 6 minute walk test through week 24||meters||Standard Deviation|Mean
839207|NCT01316575|Secondary|Length of Stay in Hospital||Up to 2 weeks|||days||Standard Deviation|Mean
839208|NCT01316575|Secondary|Number of Participants Requiring Admission to ICU||Up to 2 weeks|||participants|||Number
839209|NCT01316575|Secondary|Number of Participants Requiring Reintubation||Up to 2 weeks|||participants|||Number
839210|NCT01316575|Primary|Alveolar - Arterial Gradient|Alveolar - arterial gradient|1 hour following admission to PACU|From the literature, a sample size of 19 subjects per group is required for a power >0.9 and alpha <0.05 assuming a normalised difference in A-a gradient between groups of 0.33 and a Standard Deviation (SD) of 0.33||torr||Standard Deviation|Mean
839211|NCT01316614|Secondary|Amount of Blood||At the time of EUS-FNA procedure (Day 1)|100 participants were analyzed. Each participant had an equal number of passes with a stylet and without a stylet. 275 passes were performed with a stylet and 275 passes were performed without a stylet. The actual passes are represented in the table.||passes|||Number
839212|NCT01316614|Secondary|Contamination|Percentage of area of slide that represents GI contamination|At the time of EUS-FNA procedure (Day 1)|100 participants were analyzed. Each participant had an equal number of passes with a stylet and without a stylet. 275 passes were performed with a stylet and 275 passes were performed without a stylet. The actual passes are represented in the table.||passes|||Number
839213|NCT01316614|Secondary|Adequacy of Specimen||At the time of EUS-FNA procedure (Day 1)|100 participants were analyzed. Each participant had an equal number of passes with a stylet and without a stylet. 275 passes were performed with a stylet and 275 passes were performed without a stylet. The actual passes are represented in the table.||passes|||Number
839214|NCT01316614|Secondary|Degree of Cellularity|Number of cells per slide|At the time of EUS-FNA procedure (Day 1)|100 participants were analyzed. Each participant had an equal number of passes with a stylet and without a stylet. 275 passes were performed with a stylet and 275 passes were performed without a stylet. The actual passes are represented in the table.||passes|||Number
839215|NCT01316614|Secondary|Degree of Cellularity|Percentage of area of slide that contains cells of the representative lesion|At the time of EUS-FNA procedure (Day 1)|100 participants were analyzed. Each participant had an equal number of passes with a stylet and without a stylet. 275 passes were performed with a stylet and 275 passes were performed without a stylet. The actual passes are represented in the table.||passes|||Number
839326|NCT01317797|Primary|Number of Participants With Clinically Significant Physical Examination Findings|The physical examination included body system assessments: eyes, head and neck (including thyroid), ears, nose and throat, lymph nodes, cardiovascular, lungs, mammae, abdomen (liver, spleen), genitals, limbs, central and peripheral nervous system, musculoskeletal system, skin & nails, mucosae. The Investigator classified abnormal findings as either clinically significant or not clinically significant.|From Day 1 Up to Day 118|Safety population included all randomized participants who received study drug.||participants|||Number
839216|NCT01316614|Primary|Compare Adequacy of Diagnoses in Passes With and Without a Stylet|"The number of passes was determined by the lesion site and mirrored clinical practice (6 passes for pancreatic/other lesions and 4 passes for lymph nodes). The order of these passes was determined by a preprinted randomization sequence kept in an opaque sealed envelope that was opened by the research coordinator or EUS technologist after enrollment. Each participant had an equal number of passes with stylet and without stylet.
There was no communication between the endosonographer and the cytopathologist regarding the adequacy of the specimen or diagnosis until all passes had been completed. The on-site evaluation of smears was performed to assess cellular adequacy and to assess the need for any additional passes. Additional passes were made at the discretion of the endosonographer as clinically indicated but were not included in the final analysis. The cytology slides were evaluated by 3 experienced cytopathologists who were all blinded to the stylet status of the passes."|At the time of EUS-FNA procedure (Day 1)|100 participants were analyzed. Each participant had an equal number of passes with a stylet and without a stylet. 275 overall passes were performed with a stylet and 275 passes were performed without a stylet. The actual passes are represented in the table.||passes|||Number
839217|NCT01316692|Other Pre-specified|Correlation Between MLN8237-induced Selective Aurora Kinase A Inhibition in Post-treatment Tumor Sites and Clinical Benefit of MLN8237|In stage 2 patients: tumor biopsies are taken before initiation of treatment and on the 8th day of the first cycle of treatment. Post-treatment tumor tissue will be assayed for MLN8237-induced selective Aurora Kinase A inhibition and compared to pre-treatment tumor tissue and the results will be compared and contrasted with patients’ objective clinical responses, as determined by RECIST 1.1, after 18 weeks of treatment|At 24 weeks|unable to collected the required number of tumor samples|||||
839218|NCT01316692|Other Pre-specified|Characterize the de Novo Molecular Mutation Profile of the Melanomas for Association Between Objective Responses to MLN8237 in Patients With Pre-treatment Melanoma Tissue.|In stage 1 patients: tumor biopsies are taken before initiation of treatment and on the 8th day of the first cycle of treatment. Tissue will be assayed for mutations that are neither parent-possessed, nor able to be transmitted, in pre- and in post-treatment tissue and the results will be compared and contrasted with patients’ objective clinical responses, as determined by RECIST 1.1, after 18 weeks of treatment|At 24 weeks|Collected samples of tumors were very limited. It did not allow us to perform the described assays|||||
839219|NCT01316692|Secondary|Number of Grade 3 and 4 Study-related Toxicities|Event are graded using National Cancer Institute Common Toxicity Criteria with grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life-threatening/disabling, 5 = death. toxicities measured on day 1 of each 21-day cycle. Treatment continues to disease progression, toxicity, or withdrawal for other reasons.|at 18 weeks|total numbers of adverse events, patients experiencing grade 3 and 4 related to study treatment||toxicities|||Number
839220|NCT01316692|Secondary|Overall Survival|Estimated probable duration of life from on‐study date to date of death from any cause, using the Kaplan‐Meier method with censoring (see analysis population description for additional details) Evaluated every 3 months for 12 months, then every 6 months|On treatment date to last follow-up or death for any reason, up to 5 years|All patients are included in the analysis on intention‐to-treat basis. Analysis is by Kaplan‐Meier method, where death is an event, with censoring for non‐expired patients at greater of off‐study date or last known alive date.||days||95% Confidence Interval|Median
839221|NCT01316692|Secondary|Progression-free Survival|Progression-free survival (PFS) is defined as the duration in time from start of therapy to last follow-up, disease progression, or death for any reason.measured every 6 weeks for 24 weeks, and then every 12 weeks or to last date known alive or death, determined every 6 months for up to 5 years. For those who are alive and without progression, they are censored at the last date known alive.|On treatment date to last follow-up, disease progression or death for any reason, up to 5 years|All patients are included in the analysis on intention‐to treat basis. Analysis is by Kaplan‐Meier method, where death is an event, with censoring for non‐expired patients at greater of off‐study date or last known alive date.||days||95% Confidence Interval|Median
839222|NCT01316692|Primary|Overall Response Rate|If 2 or more of 23 pts show CR/PR in stage 1, then an additional 33 pts will be enrolled in stage 2. If 6 or more of the total 56 pts show CR/PR at 18 weeks, then further clinical trials will be warranted. Per Response Evaluation Criteria in Solid Tumor (RECIST)1.1: Complete response (CR): disappearance of all target lesions. Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR>PR>SD>PD.|At 18 weeks|All patients with Objective Response, defined as a complete or partial response.||participants||95% Confidence Interval|Number
839223|NCT01316887|Secondary|Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) at Months 1, 3, 6, 9, and 12|FEV1 and FVC are measures of lung function. FEV1 is defined as the maximal amount of air that can be forcefully exhaled in one second. FVC is defined as the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. Trough FEV1 and FVC were the values obtained approximately 24 hours after the previous morning’s dose of study medication. Baseline is the value recorded pre-dose on Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using a repeated measures model with covariates of treatment, Baseline (assessment made immediately pre-dose on Day 1), smoking status, center group, month, and month by Baseline and month by treatment interactions.|Baseline; Months 1, 3, 6, 9, and 12|ITT Population. The overall number of participants reflects all participants who provided at least one post-treatment assessment. Participants who provided data the specified time points are represented by n=X, X, X in the category titles.||Liters||Standard Error|Least Squares Mean
839224|NCT01316887|Secondary|Change From Baseline in the Percentage of Rescue-free Days Over the Course of the 52-week Treatment Period|Rescue-free days are defined as days on which albuterol/salbutamol and/or ipratropium bromide was not used. Baseline is the percentage during the week prior to Day 1. Change from Baseline was calculated as the mean percentage of rescue-free days over Weeks 1-52 minus the mean percentage of rescue-free days at Baseline.|From the start of study drug up to 52 weeks|ITT Population. Only those participants who had rescue data available on at least 50% of the days in the 52-week treatment period were included in the summary.||Percentage of rescue-free days||Standard Deviation|Mean
839226|NCT01316887|Secondary|Number of Participants With the Indicated Change From Screening to Any Time Post-Baseline in Holter ECG Interpretation|"Twenty-four hour Holter monitor (12-lead) evaluations were obtained. Holter Baseline values were those recorded at Screening. An any time post-Baseline Holter evaluation was derived as the worst evaluation recorded at any scheduled, unscheduled, or early withdrawal visit made after the start of study treatment. Change from Screening was calculated as the post-Screening value minus the Screening value. The order of severity for change from Screening Holter evaluation from worst to best is: clinically significant change: unfavorable; no change or insignificant change; clinically significant change: favorable, unable to compare, based on the assessment of the independent cardiologists."|Screening; from the start of study drug up to 52 weeks|ITT Population. Only those participants providing at least one post-Baseline interpretation were summarized.||Participants|||Number
839227|NCT01316887|Secondary|Number of Participants With the Indicated ECG Result Interpretations at Any Time Post-Baseline|Post-Baseline visits include scheduled, unscheduled, and Early Withdrawal visits. Only the worst-case interpretation was counted for each participant. Clinical significance and abnormal/normal findings are based on the assessment of the independent cardiologists.|From the start of study drug up to 52 weeks|ITT Population||participants|||Number
839228|NCT01316887|Secondary|Maximum Change From Baseline in the ECG Parameter of Heart Rate Over the Course of the 52-week Treatment Period|12-lead ECG measurements were obtained. Baseline is defined as the most recent recorded value before dosing on Day 1. The maximum post-Baseline value for heart rate was derived using any scheduled, unscheduled, or early withdrawal visit made after the start of study treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; from the start of study drug up to 52 weeks|ITT Population||Beats per minute||Standard Deviation|Mean
839229|NCT01316887|Secondary|Maximum Change From Baseline in the Electrocardiogram (ECG) Parameters of QT Interval Corrected for Heart Rate by Bazett’s Formula (QTcB), QT Interval Corrected for Heart Rate by Fridericia’s Formula (QTcF), and PR Interval Over the Course of the 52-week|12-lead ECG measurements were obtained. Baseline is defined as the most recent recorded value before dosing on Day 1. The maximum post-Baseline values for QTcF, QTcB, and PR interval were derived using any scheduled, unscheduled, or early withdrawal visit made after the start of study treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; from the start of study drug up to 52 weeks|ITT Population||Milliseconds||Standard Deviation|Mean
839230|NCT01316887|Secondary|Maximum Change From Baseline in Pulse Rate Over the Course of the 52-week Treatment Period|Baseline is defined as the most recent recorded value before dosing on Day 1. The maximum post-Baseline value for pulse rate was derived using any scheduled, unscheduled, or early withdrawal visit made after the start of study treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; from the start of study drug up to 52 weeks|ITT Population||Beats per minute||Standard Deviation|Mean
839231|NCT01316887|Secondary|Change From Baseline to Maximum Systolic Blood Pressure (SBP) and Change From Baseline to Minimum Diastolic Blood Pressure (DBP) Over the Course of the 52-week Treatment Period|Baseline is defined as the most recent recorded value before dosing on Day 1. The maximum post-Baseline value for SBP and the minimum post-Basline value for DBP were derived using any scheduled, unscheduled, or early withdrawal visit made after the start of study treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; from the start of study drug up to 52 weeks|ITT Population||Millimeters of mercury (mmHg)||Standard Deviation|Mean
839232|NCT01316887|Secondary|Change From Baseline in Hematocrit at Months 3, 6, 9, and 12|"Blood samples were collected for the measurement of hematocrit at Baseline and Months 3, 6, 9, and 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The value defined as the Baseline value is the most recent value collected prior to the start of treatment. For most participants, the Baseline value is the value collected at the Screening visit; however, for some participants, the Baseline value may have been collected at an unscheduled visit."|Baseline; Months 3, 6, 9, and 12|ITT Population. Only those participants available at the specified time points were summarized (represented by n=X, X, X in the category titles). Different participants may have been summarized at different time points, so the overall number of participants summarized reflects everyone in the ITT Population.||Proportion of red blood cells in blood||Standard Deviation|Mean
839233|NCT01316887|Secondary|Change From Baseline in Eosinophil Count, Platelet Count, and White Blood Cell (WBC) Count at Months 3, 6, 9, and 12|"Blood samples were collected for the measurement of eosinophils, platelets, and WBC count at Baseline and Months 3, 6, 9, and 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The value defined as the Baseline value is the most recent value collected prior to the start of treatment. For most participants, the Baseline value is the value collected at the Screening visit; however, for some participants, the Baseline value may have been collected at an unscheduled visit."|Baseline; Months 3, 6, 9, and 12|ITT Population. Only those participants available at the specified time points were summarized (represented by n=X, X, X in the category titles). Different participants may have been summarized for different parameters/at different time points, so the overall number of participants summarized reflects everyone in the ITT Population.||10^9 cells per liter (GI/L)||Standard Deviation|Mean
839234|NCT01316887|Secondary|Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12|"Blood samples were collected for the measurement of the percentage of basophils, eosinophils, lymphocytes, monocytes, and segmented neutrophils at Baseline and Months 3, 6, 9, and 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The value defined as the Baseline value is the most recent value collected prior to the start of treatment. For most participants, the Baseline value is the value collected at the Screening visit; however, for some participants, the Baseline value may have been collected at an unscheduled visit."|Baseline; Months 3, 6, 9, and 12|ITT Population. Only those participants available at the specified time points were summarized (represented by n=X, X, X in the category titles). Different participants may have been summarized for different parameters/at different time points, so the overall number of participants summarized reflects everyone in the ITT Population.||Percentage in blood||Standard Deviation|Mean
839327|NCT01317797|Primary|Number of Participants With Clinically Significant Pulmonary Function Tests|Pulmonary function was determined by forced expiratory volume in the first second (FEV1), forced vital capacity (FVC) and peak flow.|From Day 1 Up to Day 118|Safety population included all randomized participants who received study drug.||participants|||Number
839235|NCT01316887|Secondary|Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12|"Blood samples were collected for the measurement of creatinine, direct bilirubin, indirect bilirubin, total bilirubin, and uric acid at Baseline and Months 3, 6, 9, and 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The value defined as the Baseline value is the most recent value collected prior to the start of treatment. For most participants, the Baseline value is the value collected at the Screening visit; however, for some participants, the Baseline value may have been collected at an unscheduled visit."|Baseline; Months 3, 6, 9, and 12|ITT Population. Only those participants available at the specified time points were summarized (represented by n=X, X, X in the category titles). Different participants may have been summarized for different parameters/at different time points, so the overall number of participants summarized reflects everyone in the ITT Population.||Micromoles per liter (µmol/L)||Standard Deviation|Mean
839236|NCT01316887|Secondary|Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate, Chloride, Glucose, Inorganic Phosphorus (IP), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Months 3, 6, 9, and 12|"Blood samples were collected for the measurement of calcium, CO2 content/bicarbonate, chloride, glucose, IP, potassium, sodium, and urea/BUN at Baseline and Months 3, 6, 9, and 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The value defined as the Baseline value is the most recent value collected prior to the start of treatment. For most participants, the Baseline value is the value collected at the Screening visit; however, for some participants, the Baseline value may have been collected at an unscheduled visit."|Baseline; Months 3, 6, 9, and 12|ITT Population. Only those participants available at the specified time points were summarized (represented by n=X, X, X in the category titles). Different participants may have been summarized for different parameters/at different time points, so the overall number of participants summarized reflects everyone in the ITT Population.||Millimoles per liter (mmol/L)||Standard Deviation|Mean
839237|NCT01316887|Secondary|Change From Baseline in Albumin, Total Protein, and Hemoglobin at Months 3, 6, 9, and 12|"Blood samples were collected for the measurement of albumin, total protein, and hemoglobin at Baseline and Months 3, 6, 9, and 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The value defined as the Baseline value is the most recent value collected prior to the start of treatment. For most participants, the Baseline value is the value collected at the Screening visit; however, for some participants, the Baseline value may have been collected at an unscheduled visit."|Baseline; Months 3, 6, 9, and 12|ITT Population. Only those participants available at the specified time points were summarized (represented by n=X, X, X in the category titles). Different participants may have been summarized for different parameters/at different time points, so the overall number of participants summarized reflects everyone in the ITT Population.||Grams per liter (G/L)||Standard Deviation|Mean
839238|NCT01316887|Secondary|Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) at Months 3, 6, 9, and 12|"Blood samples were collected for the measurement of ALT, ALP, AST, CK, and GGT at Baseline and Months 3, 6, 9, and 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The value defined as the Baseline value is the most recent value collected prior to the start of treatment. For most participants, the Baseline value is the value collected at the Screening visit; however, for some participants, the Baseline value may have been collected at an unscheduled visit."|Baseline; Months 3, 6, 9, and 12|ITT Population. Only those participants available at the specified time points were summarized (represented by n=X, X, X in the category titles). Different participants may have been summarized for different parameters/at different time points, so the overall number of participants summarized reflects everyone in the ITT Population.||International units per liter (IU/L)||Standard Deviation|Mean
839239|NCT01316887|Secondary|Time to the First On-treatment COPD Exacerbation|An on-treatment COPD exacerbation is defined as worsening symptoms of COPD requiring a systemic corticosteroid, an antibiotic, and/or hospitalization at any time during the 52-week Treatment Period. The time to the first on-treatment exacerbation was calculated as the exacerbation onset date of the first on-treatment exacerbation minus the date of the start of treatment + 1. The median time to the first on-treatment exacerbation was derived from the Kaplan-Meier analysis. A participant who did not experience an exacerbation prior to completing the study or withdrawal is considered censored; a time to first COPD exacerbation cannot be calculated for these participants.|From the start of study drug up to 52 weeks|ITT Population||Days||Full Range|Median
839240|NCT01316887|Secondary|Number of Participants With at Least One Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Over the Course of the 52-week Treatment Period|A COPD exacerbation is defined as worsening symptoms of COPD requiring a systemic corticosteroid, an antibiotic, and/or hospitalization.|From the start of study drug up to 52 weeks|ITT Population||Participants|||Number
839241|NCT01316887|Primary|Number of Participants With Any On-treatment Adverse Event (AE) or Any Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury with hyperbilirubinaemia. Medical or scientific judgment was to have been exercised in other important medical events. AEs with an onset on or after the date of the first dose of study drug and up to 1 day after the date of the last recorded dose of study drug were considered to be on-treatment AEs, Refer to the general AE/SAE module for a complete list of AEs and SAEs.|From the start of study drug up to 52 weeks|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study drug||Participants|||Number
839265|NCT01316939|Secondary|Change From Baseline in Vital Sign Systolic Blood Pressure Systolic (SBP) and Diastolic Blood Pressure (DBP) Upto Week 56|Vital sign assessments included SBP and DBP collected in supine position following 5 minutes of rest. Assessments were carried out at Weeks 4, 8, 12, 20, 28, 36, 44, 52 and Week 56. Baseline was defined as value at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at the time of assessment.|Baseline (Week 0) and Weeks 4, 8, 12, 20, 28, 36, 44, 52, 56|Safety Population. Only those participants available at the specified time points were analyzed.||Millimeters of mercury||Standard Deviation|Mean
839242|NCT01316900|Other Pre-specified|Change From Baseline (BL) in the Mean Shortness of Breath With Daily Activities (SOBDA) Score for Week 24|The newly developed SOBDA questionnaire assesses dyspnea or shortness of breath (SOB) with daily activities. The SOBDA questionnaire is made up of 13 items completed by the participant (par.) each evening prior to bedtime, when the par. is instructed to reflect on the current day’s activities. The daily score is computed as the mean of the scores on the 13 items (>=7 items must have non-missing responses for this to be calculated). The par. is assigned a weekly mean SOBDA score ranging from 1 to 4 (greater scores indicate more severe breathlessness with daily activities) based on the mean of 7 days of data (>=4 of 7 days must be completed for a weekly mean to be calculated). Change from BL is the mean weekly SOBDA score minus BL. Analysis was performed using MMRM with covariates of treatment, BL (mean score in the week prior to treatment), smoking status, center group, week, week by BL and week by treatment interactions. This MMRM analysis only included Weeks 4, 8, 12, and 24.|Baseline and Week 24|ITT Population excluding participants from Investigator 040688. Participants analyzed are those with data available at the presented time point; but, all participants without missing covariate information and with >=1 post-Baseline measurement were included in the analysis.||Scores on a scale||Standard Error|Least Squares Mean
839243|NCT01316900|Secondary|Change From Baseline (BL) in Weighted Mean (WM) 0-6 Hour FEV1 Obtained Post-dose at Day 168|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The WM FEV1 was derived by calculating the area under the FEV1/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. The WM was calculated at Days 1, 84, and Day 168 using the 0-6-hour post-dose FEV1 measurements collected on that day, which included pre-dose (Day 1: 30 minutes [min] and 5 min prior to dosing; other serial visits: 23 and 24 hours after the previous morning dose) and post-dose at 15 minutes, 30 minutes, 1 hour, 3 hours, and 6 hours. Change from BL at a particular visit was calculated as WM at that visit minus BL. Analysis was performed using a repeated measures model with covariates of treatment, BL (mean of the two assessments made 30 minutes and 5 minutes pre-dose on Day 1), smoking status, center group, day, and day by BL and day by treatment interactions.|Baseline and Day 168|ITT Population excluding participants from Investigator 040688. Par. analyzed are those with data available at the presented time point; but, all par. without missing covariate information and with >=1 post-Baseline measurement were included in the analysis.||Liters||Standard Error|Least Squares Mean
839244|NCT01316900|Primary|Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 169 (Week 24)|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 measurements were taken electronically by spirometry on Days 2, 28, 56, 84, 112, 168, and 169. Baseline is defined as the mean of the assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1. Trough FEV1 is defined as the mean of the FEV1 values obtained at 23 and 24 hours after the previous morning's dosing (ie., trough FEV1 on Day 169 is the mean of the FEV1 values obtained 23 and 24 hours after the morning dosing on Day 168). Change from Baseline at a particular visit was calculated as the trough FEV1 at that visit minus Baseline. Analysis was performed using a repeated measures model with covariates of treatment, Baseline , smoking status, center group, day, and day by Baseline and day by treatment interactions. ITT=Intent-to-Treat; par.=participants. .|Baseline and Day 169|ITT Population excluding par. from Investigator 040688: all randomized par. who received >=1 dose of study drug, except for those from Investigator 040688. Par. analyzed are those with data available at the presented time point; but, all par. without missing covariate information and with >=1 post-BL measurement were included in the analysis.||Liters||Standard Error|Least Squares Mean
839245|NCT01316913|Other Pre-specified|Change From Baseline (BL) in the Mean Shortness of Breath With Daily Activities (SOBDA) Score for Week 24|The newly developed SOBDA questionnaire assesses dyspnea or shortness of breath (SOB) with daily activities. The SOBDA questionnaire is made up of 13 items completed by the participant (par.) each evening prior to bedtime, when the par. is instructed to reflect on the current day’s activities. The daily score is computed as the mean of the scores on the 13 items (>=7 items must have non-missing responses for this to be calculated). The par. is assigned a weekly mean SOBDA score ranging from 1 to 4 (greater scores indicate more severe breathlessness with daily activities) based on the mean of 7 days of data (>=4 of 7 days must be completed for a weekly mean to be calculated). Change from BL is the mean weekly SOBDA score minus BL. Analysis was performed using MMRM with covariates of treatment, BL (mean score in the week prior to treatment), smoking status, center group, week, week by BL and week by treatment interactions. This MMRM analysis only included Weeks 4, 8, 12, and 24.|Baseline and Week 24|ITT Population. Participants analyzed are those with data available at the presented time point; but, all participants without missing covariate information and with >=1 post-Baseline measurement were included in the analysis.||scores on a scale||Standard Error|Least Squares Mean
839246|NCT01316913|Secondary|Change From Baseline (BL) in Weighted Mean (WM) 0-6 Hour FEV1 Obtained Post-dose at Day 168|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The WM FEV1 was derived by calculating the area under the FEV1/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. The WM was calculated at Days 1, 84, and Day 168 using the 0-6-hour post-dose FEV1 measurements collected on that day, which included pre-dose (Day 1: 30 minutes [min] and 5 min prior to dosing; other serial visits: 23 and 24 hours after the previous morning dose) and post-dose at 15 minutes, 30 minutes, 1 hour, 3 hours, and 6 hours. Change from BL at a particular visit was calculated as WM at that visit minus BL. Analysis was performed using a repeated measures model with covariates of treatment, BL (mean of the two assessments made 30 minutes and 5 minutes pre-dose on Day 1), smoking status, center group, day, and day by BL and day by treatment interactions.|Baseline and Day 168|ITT Population. Par. analyzed are those with data available at the presented time point; but, all par. without missing covariate information and with >=1 post-Baseline measurement were included in the analysis.||Liters||Standard Error|Least Squares Mean
839311|NCT01317667|Secondary|Over Response Rates and Comparisons for ELISA and TNA Titers|Overall response is defined as a subject having a response at any time after vaccination. A response is defined as subjects who developed total ELISA IgG titers (≥ 1:500) and TNA anti-ricin toxin-neutralizing antibody titers (≥ 1:50) at each scheduled time point for which blood samples were taken for each group and over the entire study period to study completion.|Day 7, 14, 28, 35, 42, 56, 63, 70, 84, month 6, 9, and 12|Per-protocol population. Only observations or specimens collected according to the protocol were included in the immunogenicity analyses.||participants|||Number
839247|NCT01316913|Primary|Change From Baseline in Clinic Visit Trough Forced Expiratory Volume in One Second (FEV1) at Day 169|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 measurements were taken electronically by spirometry on Days 2, 28, 56, 84, 112, 168, and 169. Baseline is defined as the mean of the assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1. Trough FEV1 is defined as the mean of the FEV1 values obtained at 23 and 24 hours after the previous morning's dosing (i.e., trough FEV1 on Day 169 is the mean of the FEV1 values obtained 23 and 24 hours after the morning dosing on Day 168). Change from Baseline at a particular visit was calculated as the trough FEV1 at that visit minus Baseline. Analysis was performed using a repeated measures model with covariates of treatment, Baseline, smoking status, center group, day, and day by Baseline and day by treatment interactions. ITT=Intent-to-Treat.|Baseline and Day 169|ITT Population: all participants randomized to treatment who received at least one dose of randomized study drug in the Treatment Period. Participants analyzed are those with data available at the presented time point; but, all participants without missing covariate information and with >=1 post-Baseline measurement were included in the analysis.||Liters||Standard Error|Least Squares Mean
839248|NCT01316926|Primary|Cmax_steady-state|Cmax_steady-state (ss) is defined as the maximum or “peak” concentration of a drug observed after its administration, in steady-state. Cmax_ss is one of the parameters of particular use in estimating the bioavailability of drugs, by measuring the total amount of drug absorbed.|Days 14 to 17 (Period 1) and Days 23 to 24 (Period 2)|Participants who completed the study||ng/ml||Standard Deviation|Mean
839249|NCT01316926|Primary|Cmin_steady-state|Cmin_steady-state (ss) is defined as the minimum concentration of a drug observed after its administration in steady-state. Cmin_ss is one of the parameters of particular use in estimating the bioavailability of drugs, for studies employing multiple doses.|Days 14 to 17 (Period 1) and Days 23 to 24 (Period 2)|Participants who completed the study||ng/ml||Standard Deviation|Mean
839250|NCT01316926|Primary|Area Under the Curve_steady-state|The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC_steady-state (ss) is the area under the curve during the steady-state period. The AUC_ss is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. ng, nanogram; h, hour; ml, milliliter. ng.h/ml, nanograms per hour per milliliter.|Days 14 to 17 (Period 1) and Days 23 to 24 (Period 2)|Participants who completed the study||ng/h/ml||Standard Deviation|Mean
839251|NCT01316939|Secondary|Change From Baseline in Faecal Calprotectin at Weeks 28 and 52|Stool sample for faecal calprotectin were to be collected at Weeks 28 and 52 visit if applicable. Data for Change from baseline in faecal calprotectin at Weeks 28 and 52 was not collected following early termination of this study. Baseline was defined as value at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at the time of assessment.|Baseline (Week 0) and Weeks 28 and 52|ITT Population. Following early termination of study CCX114157 data for Change from Baseline in faecal calprotectin at Weeks 28 and 52 was not collected.|||||
839252|NCT01316939|Secondary|Change From Baseline in C Reactive Protein (CRP) at Weeks 28 and 52|C-reactive protein (CRP) at was to be assessed at Weeks 4, 8, 12, 20, 28, 36, 44, 52 visit if applicable. Data for Change from Baseline in C reactive protein (CRP) at Weeks 28 and 52 was not collected following early termination of this study. Baseline was defined as value at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at the time of assessment.|Baseline (Week 0 and Weeks 28 and 52|ITT Population. Following early termination of study CCX114157 data for Change from Baseline in C reactive protein (CRP) at Weeks 28 and 52 was not collected.|||||
839253|NCT01316939|Secondary|Change From Baseline in Health-related Resource Utilization at Weeks 28 and 52|Healthcare related resource utilization was to include: Hospitalizations (all cause and Crohn’s disease related), Length of stay, Surgical procedures (all cause and Crohn’s disease related), Outpatient visits (all cause and Crohn’s disease related ). The frequency of hospitalizations, surgical procedures and hospital out-patient visits were to be recorded at Weeks 28 and 52. The number and percentage of participants reporting all cause and Crohn’s disease -related hospitalizations, surgeries, and hospital out-patient visits were to be summarized and compared between each GSK1605786A dose group and placebo using Fisher’s exact test. Data for Change from Baseline in health-related resource utilization at Weeks 28 and 52 was not collected following early termination of this study. Baseline was defined as value at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at the time of assessment.|Baseline (Week 0) and Weeks 28 and 52|ITT Population. Following early termination of study CCX114157 data for Change from Baseline in health-related resource utilization at Weeks 28 and 52 was not collected.|||||
839254|NCT01316939|Secondary|Receipt of Disability Benefits at Weeks 28 and 52|Receipt of disability benefits (Yes/No) was to be recorded at Weeks 0, 28 and 52 and Early Withdrawal visit if applicable. Change from baseline in receipt of disability benefits was to be compared between participants in remission versus participants not in remission using a Wilcoxon rank sum test. Data for Receipt of disability benefits at Weeks 28 and 52 was not collected following early termination of this study.|Weeks 28 and 52|ITT population. Following early termination of study CCX114157 data for Receipt of disability benefits at Weeks 28 and 52 was not collected.|||||
839255|NCT01316939|Secondary|Change From Baseline in Work Productivity & Activity Impairment – Crohn’s Disease (WPAI-CD) at Weeks 28 and 52|WPAI measures the effect of your CD on your ability to work and perform regular activities. 6-items assess impairment in work productivity and daily activity during the 7 days before the assessment. It measures the percentage of overall impairment in work productivity and daily activity due to CD. A WPAI score of 0% = no impairment and a score of 100% = total loss of work productivity or activity. An absolute change in WPAI score of 7% is considered the minimum clinically important difference (MCID). Data for change from Baseline in WPAI-CD at Weeks 28 and 52 was not collected following early termination of this study. Baseline was defined as value at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at the time of assessment.|Baseline (Week 0) and Weeks 28 and 52|ITT Population. Following early termination of study CCX114157 data for Change from Baseline in Work productivity & activity impairment – Crohn’s disease (WPAI-CD) at Weeks 28 and 52 was not collected.|||||
839312|NCT01317667|Primary|Number of Vaccinated Subjects Any Averse Events and by Location and Severity||Days 1, 3, 7, 14, and 28 after each vaccination and at 6 and 9 months|Safety population: any subject receiving a vaccination||participants|||Number
839256|NCT01316939|Secondary|Change From Baseline in European Quality of Life (EuroQol ) Five Dimensions Questionnaire (EQ-5D) at Weeks 28 and 52|EQ-5D self-reported questionnaire is used to measure health-related quality of life by measuring 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D questionnaire includes a visual analog scale (VAS) which records participants self-rated health status on a graduated (0–100) scale with higher scores indicating higher Health-Related Quality of Life (HRQoL). Data for Change from Baseline in EuroQol five dimensions questionnaire (EQ-5D) at Weeks 28 and 52 was not collected following early termination of this study. Baseline was defined as value at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at the time of assessment.|Baseline (Week 0) and Weeks 28 and 52|ITT Population. Following early termination of study CCX114157 data for Change from Baseline in European Quality of Life (EuroQol ) five dimensions questionnaire (EQ-5D) at Weeks 28 and 52 was not collected.|||||
839257|NCT01316939|Secondary|Change From Baseline in Short Form – 36 Version 2 (SF-36 v2) at Weeks 28 and 52|The SF-36v2 health survey is a self-administered, generic, 36-item questionnaire designed to measure 8 domains of functional health status and well-being: physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. Each domain is scored from 0 (poorer health) to 100 (better health). SF-36 v2 items are scored such that a higher score indicates a better health state and better functioning. Data for change from Baseline in SF-36 v2 at Weeks 28 and 52 was not collected following early termination of this study. Baseline was defined as value at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at the time of assessment.|Baseline (Week 0) and Weeks 28 and 52|ITT Population. Following early termination of study CCX114157 data for change from Baseline in SF-36 v2 at Weeks 28 and 52 was not collected.|||||
839258|NCT01316939|Secondary|Number of Participants With 12 Lead Electocardiogram (ECG) Abnormalities at Week 28 and 52|A 12 lead ECG was collected at Weeks 28 and 52. ECG abnormalities were characterized as abnormal-not clinically significant (A-NCS) and abnormal-clinically significant (A-CS). A-NCS data for Week 28 and 52 have been presented.|Week 28 and 52|Safety population. Only those participants available at the specified time points were analyzed.||Participants|||Number
839259|NCT01316939|Secondary|Change From Baseline in Liver Function Test Parameter Alanine Amino Transferase, Aspartate Amino Transferase, Alkaline Phosphatase and Gamma Glutamyl Transferase at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 56|Liver function test parameters included alanine amino transferase, aspartate amino transferase, alkaline phosphatase and gamma glutamyl transferase. Assessments were carried out at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 56. Baseline was defined as value at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at the time of assessment.|Baseline (Week 0) and Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 56|Safety Population. Only those participants available at the specified time points were analyzed.||units per liter||Standard Deviation|Mean
839260|NCT01316939|Secondary|Change From Baseline in Liver Function Test Parameter Albumin at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 56|Liver function test parameter included albumin. Assessments were carried out at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 56.Baseline was defined as value at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at the time of assessment.|Baseline (Week 0) and Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 56|Safety Population. Only those participants available at the specified time points were analyzed.||grams per liter||Standard Deviation|Mean
839261|NCT01316939|Secondary|Change From Baseline in Liver Function Test Parameter Total Bilirubin at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 and 56.|Liver function test parameter included total bilirubin. Assessments were carried out at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 and 56. Baseline was defined as value at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at the time of assessment.|Baseline (Week 0) and Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 and 56.|Safety Population. Only those participants available at the specified time points were analyzed||micromoles per liter||Standard Deviation|Mean
839262|NCT01316939|Secondary|Number of Participants With Shift From Baseline in Clinical Chemistry Parameters|Clinical chemistry parameters included total protein, phosphorous, albumin, sodium, potassium, chloride, calcium, glucose, gamma glutamyl transferase, total bilirubin, direct bilirubin, alkaline phosphatase, alanine amino transferase, aspartate amino transferase, blood urea nitrogen (BUN)/Urea, creatinine, uric acid, lactate dehydrogenase, bicarbonate, cholesterol and creatinine kinase. Assessments were carried out at Weeks 4, 8, 12, 20, 28, 36, 44, 52 and 56. The consolidated data for number of participants with shift from Baseline (change from Baseline) in clinical chemistry parameters characterized as high and low have been presented.|Upto Week 56|Safety Population. Only those participants available at the specified time points were analyzed.||Participants|||Count of Participants
839263|NCT01316939|Secondary|Number of Participants With Shift From Baseline in Hematology Parameters|Hematology parameters included platelets, neutrophils, lymphocytes, monocytes, eosinophils, basophils, hematocrit, red blood cell count, hemoglobin, white blood cell count and segmented neutrophils . Assessments were carried out at Weeks 4, 8, 12, 20, 28, 36, 44 and 52 and 56. The consolidated data for number of participants with shift from Baseline (change from Baseline) in hematology parameters characterized as high and low have been presented.|Upto Week 56|Safety Population. Only those participants available at the specified time points were analyzed.||Participants|||Count of Participants
839264|NCT01316939|Secondary|Change From Baseline in Vital Sign Heart Rate Upto Week 56|Vital sign assessment included heart rate collected in supine position following 5 minutes of rest. Assessments were carried out at Weeks 4, 8, 12, 20, 28, 36, 44, 52 and 56. Baseline was defined as value at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at the time of assessment.|Baseline (Week 0) and Weeks 4, 8, 12, 20, 28, 36, 44, 52 and 56|Safety Population. Only those participants available at the specified time points were analyzed.||beats per minute||Standard Deviation|Mean
839370|NCT01318122|Secondary|Change From Baseline in Fasting Blood Glucose (Week 28).|The change between the value of fasting blood glucose collected at week 28 and baseline.|Baseline and Week 28.|Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
839266|NCT01316939|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury.|Upto 56 weeks|The Safety Population comprised of all participants in the ITT population except those who did not take at least one dose of investigational product.||Participants|||Count of Participants
839267|NCT01316939|Secondary|Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 52|The IBDQ consists of a self-administered 32-item questionnaire that evaluates quality of life across 4 dimensional scores: Bowel, Systemic, Social and Emotional. The IBDQ questionnaire was to be completed by each participant at baseline and at Weeks 28, and 52. The response to each question can range from 1 to 7, with 1 indicating severe problem and 7 indicating normal health. The total IBDQ is computed as the sum of the responses to the individual IBDQ questions. The total score can range between 32 to 224 with higher scores indicating a better quality of life. The limited data resulting from early termination of Study CCX114157 did not allow any conclusions to be drawn about the efficacy of GSK1605786A in the maintenance of clinical remission in participants with Crohn’s disease. Baseline was defined as value at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at the time of assessment.|Baseline (Week 0) and Week 52|ITT Population. Following early termination of study CCX114157 data for Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) total score at Week 52 was not collected.|||||
839268|NCT01316939|Secondary|Change From Baseline in CDAI Score at Weeks 4, 8, 12, 20, 28, 36, 44, and 52|The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity. CDAI scores and changes in CDAI scores during the 52-week treatment period were to be summarized by treatment group at Weeks 4, 8, 12, 20, 28, 36, 44, and 52. The limited data resulting from early termination of Study CCX114157 did not allow any conclusions to be drawn about the efficacy of GSK1605786A in the maintenance of clinical remission in participants with Crohn’s disease. Baseline was defined as value at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at the time of assessment.|Baseline (Week 0) and Weeks 4, 8, 12, 20, 28, 36, 44, and 52|ITT Population. Following early termination of study CCX114157 data for Change from Baseline in CDAI score at Weeks 4, 8, 12, 20, 28, 36, 44, and 52 was not collected.|||||
839269|NCT01316939|Secondary|Time to Induction of Clinical Remission in Participants Who Had Achieved Clinical Response During Induction Therapy But Were Not in Clinical Remission at Baseline|The duration of time participants maintained clinical remission during the 52-week treatment period was to be defined as the time between Week 0 and the first visit where remission was not observed in those participants in remission at baseline. These time periods were to be summarized by treatment group using quartiles and their corresponding confidence intervals. Comparisons between each GSK1605786A dose group and placebo were to be made using log-rank tests. The limited data resulting from early termination of Study CCX114157 did not allow any conclusions to be drawn about the efficacy of GSK1605786A in the maintenance of clinical remission in participants with Crohn’s disease.|Upto Week 52|ITT Population. Following early termination of study CCX114157 data for Time to induction of clinical remission in participants who had achieved clinical response during induction therapy but were not in clinical remission at Baseline was not collected.|||||
839270|NCT01316939|Secondary|Percentage of Participants With a Clinical Response (CDAI Decrease >=100 Points) at Both Weeks 28 and 52 of the 52-week Treatment Period|Clinical response is defined as a reduction from the induction study baseline CDAI score of >=100 points. The percentage of participants with a clinical response at both Weeks 28 and 52 of the 52-week maintenance treatment period in the ITT population using the no effect imputation for missing data were to be compared between each GSK1605786A dose group and placebo using Fisher’s exact test. Participants with missing CDAI scores were to be considered non-responders according to the missing=no effect imputation. The limited data resulting from early termination of Study CCX114157 did not allow any conclusions to be drawn about the efficacy of GSK1605786A in the maintenance of clinical remission in participants with Crohn’s disease.|Week 28 and 52|ITT Population. Following early termination of study CCX114157 data for Percentage of participants with a clinical response (CDAI decrease >=100 points) at both Weeks 28 and 52 of the 52-week treatment period was not collected.|||||
839271|NCT01316939|Secondary|Percentage of Participants in Clinical Remission at Week 52|The limited data resulting from early termination of Study CCX114157 did not allow any conclusions to be drawn about the efficacy of GSK1605786A in the maintenance of clinical remission in participants with Crohn’s disease.|Week 52|ITT Population. Following early termination of study CCX114157 data for Percentage of participants in clinical remission at Week 52 was not collected.|||||
839272|NCT01316939|Secondary|Percentage of Participants in Clinical Remission at All Visits (Continuous Clinical Remission) During the 52-week Treatment Period Among Participants in Clinical Remission at Baseline|The percentage of participants with clinical remission at all visits during the 52-week treatment period were to be summarized by treatment group for the subset of participants in remission at baseline, using the no effect imputation for missing data. Participants with missing CDAI scores were to be considered not to be in remission according to the missing=no effect imputation. Comparisons between each GSK1605786A dose group and placebo were to be made using Fisher’s exact test.The limited data resulting from early termination of Study CCX114157 did not allow any conclusions to be drawn about the efficacy of GSK1605786A in the maintenance of clinical remission in participants with Crohn’s disease.|Upto Week 52|ITT Population. Following early termination of study CCX114157 data for Percentage of participants in clinical remission at all visits (continuous clinical remission) during the 52-week treatment period among participants in clinical remission at Baseline was not collected.|||||
839273|NCT01316939|Secondary|Percentage of Participants in Clinical Remission at Both Weeks 28 and 52 of the 52-week Treatment Period Among Those Participants Who Were in Clinical Remission at Baseline|Clinical remission is defined as a CDAI score <150 points. Among participants in remission at baseline, the percentage of participants with clinical remission at both Weeks 28 and 52 of the treatment period using the no effect imputation for missing data were to be compared between each GSK1605786A dose group and placebo using Fisher’s exact test. Participants with missing CDAI scores were to be considered not to be in remission according to the missing=no effect imputation. The limited data resulting from early termination of Study CCX114157 did not allow any conclusions to be drawn about the efficacy of GSK1605786A in the maintenance of clinical remission in participants with Crohn’s disease.|Week 28 and 52|ITT Population. Following early termination of study CCX114157 data for Percentage of participants in clinical remission at both Weeks 28 and 52 of the 52-week treatment period among those participants who were in clinical remission at Baseline was not collected.|||||
839274|NCT01316939|Secondary|Percentage of Participants in Clinical Remission (CDAI Score <150 Points) and Not Taking Corticosteroids at Both Weeks 28 and 52 of the 52-week Treatment Period|Clinical remission is defined as a CDAI score <150 points. A participant was considered to be not taking corticosteroids at Weeks 28 and 52 if the participant had not taken a corticosteroid for the 8 days prior to and the day of the CDAI assessment for each of Weeks 28 and 52. In the missing=no effect imputation, participants with missing CDAI scores was considered not to be in clinical remission. Data for percentage of participants in clinical remission and not taking corticosteroids at both Weeks 28 and 52 of the 52-week treatment period have been presented.|Week 28 and 52|ITT Population.||Percentage of Participants|||Number
839275|NCT01316939|Primary|Percentage of Participants in Clinical Remission (Crohn’s Disease Activity Index , CDAI Score <150 Points) at Both Weeks 28 and 52 of the 52-week Treatment Period|Clinical remission is defined as a CDAI score <150 points. In the missing=no effect imputation, participants with missing CDAI scores was considered not to be in clinical remission. Data for percentage of participants in at both Weeks 28 and 52 of the 52-week treatment period have been presented.|Week 28 and 52|The Intent-to-Treat (ITT) Population comprised of all participants randomized to treatment who achieved a clinical response (CDAI decrease from baseline of >=100 points) or achieved clinical remission (CDAI <150 points).||Percentage of Participants|||Number
839276|NCT01317004|Secondary|Physician-reported Clinical Global Impression of Improvement (CGI-I)|The CGI-I is a rating scale allowing a physician-reported global evaluation of the subject's improvement over time. The Investigator assessed the subject's clinical change relative to the symptoms at baseline on the CGI-I, a seven-point scale, with rating as follows: 1=Very much improved, 2=Much improved, 3=Minimally improved, 4=No change, 5=Minimally worse, 6=Much worse, 7=Very much worse. A lower score and a negative change from baseline indicate improvement.|6 months|Participants from the safety set, who had values at month 6, were included in the analysis. The safety set included randomized participants who received at least one dose of study medication.||Percentage of participants|||Number
839277|NCT01317004|Secondary|Change From Baseline in Patient-reported Health Related Quality of Life (QOL)|The SF-36v2 is a validated health-related quality of life instrument used in numerous disease states, including MS. It is a self-administered survey that measures 8 domains of health including: physical functioning, role limitations due to physical health, pain, general health, energy/fatigue, social functioning, role limitations due to emotional problems and emotional well-being. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). If half or more questions within a domain were answered, then a score was calculated for that domain. Otherwise, the patient score for that domain was set to missing. If the patient was missing any 1 of the 8 scale scores, then the physical and mental component scores were set to missing. An algorithm was used to create a score from 0 to 100 for each domain score and component score. A positive change from baseline indicates improvement.|6 months|Participants from the safety set, who had values at both baseline and month 6, were included in the analysis. The safety set included randomized participants who received at least one dose of study medication.||score on a scale||Standard Deviation|Mean
839278|NCT01317004|Secondary|Change From Baseline in Patient-reported Depression|The Beck Depression Inventory Fast Screen (BDI-FS) is a brief, multiple choice, self reported inventory designed to evaluate depression in patients with medical illness. The BDI-FS score was calculated summing the 7 items of the questionnaire. Each item ranged from 0 (not present) to 3 (severe). The total score ranges from 0-3 (minimal depression), 4-8 (mild depression), 9-12 (moderate depression) and 13-21 (severe depression). A negative change from baseline indicates improvement.|6 months|Participants from the safety set, who had values at both baseline and month 6, were included in the analysis. The safety set included randomized participants who received at least one dose of study medication.||score on a scale||Standard Deviation|Mean
839279|NCT01317004|Secondary|Change From Baseline in Patient–Reported Effectiveness and Convenience|The Treatment Satisfaction Questionnaire for Medication (TSQM-9) is a psychometric measure of a patient's satisfaction with medication. It consists of 3 subscales: effectiveness, convenience and global satisfaction. The scores were computed by adding items for each domain, i.e. 1 to 3 for effectiveness, 4 - 6 for convenience and 7 to 9 for global satisfaction. The lowest possible score (1 for each item and 3 for all 3 subscales) was subtracted from the composite score and divided by the greatest possible score range. The greatest range was (7-1) X 3 items = 18 for the effectiveness and convenience, and (5-1) x 3 items = 12 for global satisfaction. This provided a transformed score between 0 and 1 that was then multiplied by 100. A positive change from baseline indicates improvement.|6 months|Participants from the safety set, who had values at both baseline and month 6, were included in the analysis. The safety set included randomized participants who received at least one dose of study medication.||score on a scale||Standard Deviation|Mean
839280|NCT01317004|Secondary|Change From Baseline in Patient-reported Fatigue|The fatigue Severity Scale (FSS) is a 9-item scale used to assess fatigue. The FSS score was calculated summing the 9 items of the questionnaire and dividing by the number of non-missing items (each item is based on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree)). A negative change from baseline indicates improvement.|6 months|Participants from the safety set, who had values at both baseline and month 6, were included in the analysis. The safety set included randomized participants who received at least one dose of study medication.||score on a scale||Standard Deviation|Mean
839281|NCT01317004|Secondary|Change From Baseline in Patient-reported Activities of Daily Living (ADL)|The PRIMUS activity measure is a 15-item assessment used to evaluate patient-reported activities of daily living. The PRIMUS activities score was calculated summing the 15 items, after recoding the responses from 1 - 3 to 0 - 2. Therefore, the total score ranged from 0 - 3-, where high scores were indicative of greater function limitation. A negative change from baseline indicates improvement.|baseline, 6 months|Participants from the safety set, who had values at both baseline and month 6, were included in the analysis. The safety set included randomized participants who received at least one dose of study medication.||score on a scale||Standard Deviation|Mean
839282|NCT01317004|Primary|Change From Baseline in Patient-reported Treatment Satisfaction|The Treatment Satisfaction Questionnaire for Medication (TSQM-9) is a psychometric measure of a patient's satisfaction with medication. It consists of 3 subscales: effectiveness, convenience and global satisfaction. The scores were computed by adding items for each domain, i.e. 1 to 3 for effectiveness, 4 - 6 for convenience and 7 to 9 for global satisfaction. The lowest possible score (1 for each item and 3 for all 3 subscales) was subtracted from the composite score and divided by the greatest possible score range. The greatest range was (7-1) X 3 items = 18 for the effectiveness and convenience, and (5-1) x 3 items = 12 for global satisfaction. This provided a transformed score between 0 and 1 that was then multiplied by 100. A positive change from baseline indicates improvement.|baseline, 6 months|Participants from the safety set, who had values at both baseline and month 6, were included in the analysis. The safety set included randomized participants who received at least one dose of study medication.||score on a scale||Standard Deviation|Mean
839283|NCT01317160|Secondary|Microdialysis|At 2 weeks postoperatively in-vivo microdialysis will be performed on as described by Greve et al 2012 (DOI: 10.1111/j.1600-0838.2012.01475.x). In the microdialysate different substances will be assessed, eg. markers of tendon callus production, procollagen type I (PINP) and type III (PIIINP) N-Terminal propeptide by enzymatic quantification.|2 weeks||||||
839284|NCT01317160|Secondary|Patient-reported Outcome and Physical Activity|The patients’ symptoms and physical activity levels were assessed using four reliable and valid scores; the Achilles tendon Total Rupture Score (ATRS), Physical Activity scale (PAS), Foot and Ankle Outcome Score (FAOS) and EuroQol Group’s questionnaire (EQ-5D).|One year||||||
839285|NCT01317160|Secondary|Venous Thromboembolic Events (VTE)|"At 6 weeks postoperatively the number of participants with VTE events will be assessed by:
1) DVT detected by compression duplex ultrasound (CDU) , 2) isolated calf muscle vein thrombosis (ICMVT) detected by CDU, 3) symptomatic DVT or ICMVT detected by CDU, 4) symptomatic pulmonary embolism detected by computer tomography."|6 weeks|||participants|||Number
839286|NCT01317160|Secondary|Functional Outcome - Muscular Endurance Tests (Heel-rise)|The functional outcome will be assessed at 52 weeks post-operatively by validated muscular endurance test, i.e. heel rise test.|one year||||||
839287|NCT01317160|Primary|Venous Thromboembolic Events (VTE)|"At 2 weeks postoperatively the number of participants with VTE events will be assessed by:
1) DVT detected by compression duplex ultrasound (CDU) , 2) isolated calf muscle vein thrombosis (ICMVT) detected by CDU, 3) symptomatic DVT or ICMVT detected by CDU, 4) symptomatic pulmonary embolism detected by computer tomography."|2 weeks|Non-compliance was defined by exposure to less than ten hours of IPC. Therefore, two patients were withdrawn on this basis and the treatment group comprised 67 patients at final analysis.||participants|||Number
839288|NCT01317615|Secondary|Overall Survival (OS)|OS was defined as the time from date of start of treatment to date of death due to any cause.|12 months|All participants were included in the analysis.||Days||95% Confidence Interval|Median
839289|NCT01317615|Secondary|Progression Free Survival (PFS)|PFS was defined as the time from the date of start of treatment to date of event defined as the first documented progression or death due to any cause.|6 months|All participants were included in the analysis.||Days||95% Confidence Interval|Median
839290|NCT01317615|Secondary|Percentage of Participants With Disease Control Rate (DCR)|DCR was defined as is the percentage of participants with a best overall response of CR or PR or SD. Complete response (CR) is disappearance of all lesions (i.e. all evidence of disease, not just the target lesions) determined by 2 observations not less than 4 weeks apart; Partial response (PR) is > 30% decrease in the sum of longest diameters of target lesions compared to baseline, with response or stable disease observed in non-target lesions, and no new lesions; Stable disease (SD) is neither sufficient shrinkage to qualify for response or sufficient increase to qualify for progressive disease in target lesions, with response or stable disease observed in non-target lesions, and no new lesions; and Progressive disease (PD is: > 20% increase in the sum of longest diameters of target lesions compared to smallest sum longest diameter recorded. In addition, the sum must also demonstrate an absolute increase of at least 5mm.|3 months|All participants were included in the analysis.||Percentage of participants|||Number
839291|NCT01317615|Secondary|Percentage of Participants With Overall Response Rate (ORR)|ORR was defined as is the proportion of participants with a best overall response of CR or PR. CR is disappearance of all lesions (i.e. all evidence of disease, not just the target lesions) determined by 2 observations not less than 4 weeks apart; Partial response. PR is > 30% decrease in the sum of longest diameters of target lesions compared to baseline, with response or stable disease observed in non-target lesions, and no new lesions.|3 months|All participants were included in the analysis.||Percentage of participants|||Number
839292|NCT01317615|Secondary|Percentage of Participants Progression-free|Tumors were assessed according to Response Evaluation Criteria in Solid tumors (RECIST) to determine progression-free status. Complete response (CR) is disappearance of all lesions (i.e. all evidence of disease, not just the target lesions) determined by 2 observations not less than 4 weeks apart; Partial response (PR) is > 30% decrease in the sum of longest diameters of target lesions compared to baseline, with response or stable disease observed in non-target lesions, and no new lesions; Stable disease (SD) is neither sufficient shrinkage to qualify for response or sufficient increase to qualify for progressive disease in target lesions, with response or stable disease observed in non-target lesions, and no new lesions; and Progressive disease (PD is: > 20% increase in the sum of longest diameters of target lesions compared to smallest sum longest diameter recorded. In addition, the sum must also demonstrate an absolute increase of at least 5mm.|6 months|All participants were included in the analysis.||Percentage of participants|||Number
839371|NCT01318122|Secondary|Change From Baseline in Fasting Blood Glucose (Week 24).|The change between the value of fasting blood glucose collected at week 24 and baseline.|Baseline and Week 24.|Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
839293|NCT01317615|Primary|Percentage of Participants Progression-free|Tumors were assessed according to Response Evaluation Criteria in Solid tumors (RECIST) to determine progression-free status. Complete response (CR): disappearance of all lesions (i.e. all evidence of disease, not just the target lesions) determined by 2 observations not less than 4 weeks apart; Partial response (PR): > 30% decrease in the sum of longest diameters of target lesions compared to baseline, with response or stable disease observed in non-target lesions, and no new lesions; Stable disease (SD): neither sufficient shrinkage to qualify for response or sufficient increase to qualify for progressive disease in target lesions, with response or stable disease observed in non-target lesions, and no new lesions; Progressive disease (PD): > 20% increase in the sum of longest diameters of target lesions compared to smallest sum longest diameter recorded. In addition, the sum must also demonstrate an absolute increase of at least 5mm.|3 months|All participants were included in the analysis.||Percentage of participants|||Number
839294|NCT01317641|Secondary|Phase 1: Time to Reach the Maximum Observed Concentration (Tmax) of Major Metabolite ORM-15341 at Day 1||1 day|PK population (Day 1)||h||Standard Deviation|Median
839295|NCT01317641|Secondary|Phase 1: Maximum Plasma Concentration (Cmax) of Major Metabolite ORM-15341 at Steady-state||Day 8 predose 0 h and 0.5, 1, 1.5, 2, 4, 6 and 8 h postdose|PK population (Day 8)||ng/mL||Standard Deviation|Mean
839296|NCT01317641|Secondary|Phase 1: Area Under the Plasma-Concentration-time Curve (AUCt) of Major Metabolite ORM-15341 at Steady-state|AUC(0-8h)|Day 8 predose 0 h and 0.5, 1, 1.5, 2, 4, 6 and 8 h postdose|PK population (Day 8)||h*ng/mL||Standard Deviation|Mean
839297|NCT01317641|Secondary|Phase 1: Time to Reach the Maximum Observed Concentration (Tmax) of ODM-201 at Day 1||1 day|PK population (Day 1)||h||Standard Deviation|Median
839298|NCT01317641|Secondary|Phase 1: Maximum Plasma Concentration (Cmax) of ODM-201 at Steady-state||Day 8 predose 0 h and 0.5, 1, 1.5, 2, 4, 6 and 8 h postdose|PK population (Day 8)||ng/mL||Standard Deviation|Mean
839299|NCT01317641|Secondary|Phase 1: Area Under the Plasma-Concentration-time Curve (AUCt) of ODM-201 at Steady-state|AUC(0-8h)|Day 8 predose 0 h and 0.5, 1, 1.5, 2, 4, 6 and 8 h postdose|PK population (Day 8)||h*ng/mL||Standard Deviation|Mean
839300|NCT01317641|Secondary|Phase 1 and 2: Participants With Stable Bone Disease in Post-CYP17i Group|Number of participants with stable bone disease (no change). Radiographic bone progression was defined by the appearance of two or more new lesions on bone scan|3 months|Evaluable post-CYP17i patients with bone metastasis at baseline||participants|||Number
839301|NCT01317641|Secondary|Phase 1 and 2: Participants With Stable Bone Disease in Post-chemotherapy and CYP17i-naïve Group|Number of participants with stable bone disease (no change). Radiographic bone progression was defined by the appearance of two or more new lesions on bone scan|3 months|Evaluable Post-chemotherapy and CYP17i-naïve patients with bone metastasis at baseline||participants|||Number
839302|NCT01317641|Secondary|Phase 1 and 2: Participants With Stable Bone Disease in Chemotherapy-naïve and CYP17i-naïve Group|Number of participants with stable bone disease (no change). Radiographic bone progression was defined by the appearance of two or more new lesions on bone scan|3 months|Evaluable chemotherapy-naïve and CYP17i-naïve patients with bone metastasis at baseline||participants|||Number
839303|NCT01317641|Secondary|Phase 1 and 2: Participants With RECIST Responses in Soft Tissue in Post-CYP17i Group|Number of participants with overall complete response (CR), partial response (PR) or stable (SD) soft tissue disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) in chest, abdomen, and pelvic CT or MRI scans.|3 months|Evaluable Post-CYP17i patients||participants|||Number
839304|NCT01317641|Secondary|Phase 1 and 2: Participants With RECIST Response in Soft Tissue in Post-chemotherapy and CYP17i-naive Group|Number of participants with overall complete response (CR), partial response (PR) or stable (SD) soft tissue disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) in chest, abdomen, and pelvic CT or MRI scans.|3 months|Evaluable Post-chemotherapy and CYP17i-naïve patients||participants|||Number
839305|NCT01317641|Secondary|Phase 1 and 2: Participants With RECIST Response in Soft Tissue in Chemotherapy-naïve and CYP17i-naïve Group|Number of participants with overall complete response (CR), partial response (PR) or stable (SD) soft tissue disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) in chest, abdomen, and pelvic CT or MRI scans.|3 months|Evaluable Chemotherapy-naïve and CYP17i-naïve patients||participants|||Number
839306|NCT01317641|Secondary|Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Post-CYP17i Group|Number of participants with greater than or equal to 50% decrease in serum PSA from baseline at 12 weeks in group of participants previously treated with CYP17 inhibitor|3 months|Evaluable post-CYP17 inhibitor patients||participants|||Number
839307|NCT01317641|Secondary|Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Post-chemotherapy and CYP17i-naïve Group|Number of participants with greater than or equal to 50% decrease in serum PSA from baseline at 12 weeks in group of participants previously treated with chemotherapy but not CYP17 inhibitor|3 months|Evaluable post-chemotherapy and CYP17i-naïve patients||participants|||Number
839308|NCT01317641|Secondary|Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Chemotherapy-naïve and CYP17i-naïve Group|Number of participants with greater than or equal to 50% decrease in serum PSA from baseline at 12 weeks in group of participants who were naïve to both chemotherapy and CYP17 inhibitor|3 months|Evaluable chemotherapy-naïve and CYP17i-naïve patients||participants|||Number
839309|NCT01317641|Primary|Phase 1: Number of Dose Limiting Toxicities Used to Determine the Maximum Tolerated Dose|The MTD is defined as dose level at which 2 or more out of 6 participants experience a dose limiting toxicity (DLT)|Up to 28 days for each cohort|Safety population included all participants in Phase 1 who received any study drug.||DLTs|||Number
839310|NCT01317641|Primary|Phase 1: Number of Participants Who Experienced Dose Limiting Toxicity (DLT)|A DLT was any Grade 3 or more toxicity (by National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE version 4.03]) excluding less than Grade 4 neutropenia or thrombocytopenia, hematological toxicity lasting less than 7 days, and nausea, vomiting, diarrhea controlled with antiemetic and/or anti-diarrheal treatment.|Up to 28 days for each cohort|Safety population included all participants in Phase 1 who received any study drug.||events|||Number
839372|NCT01318122|Secondary|Change From Baseline in Fasting Blood Glucose (Week 20).|The change between the value of fasting blood glucose collected at week 20 and baseline.|Baseline and Week 20.|Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
839313|NCT01317797|Secondary|Change From Baseline in the Disease Activity Score 44-Erythrocyte Sedimentation Rate (DAS44-ESR)|Ritchie articular index (RAI); a joint count that grades the tenderness of 26 joints on a scale of 0-3); the number of swollen joints from 44 joints (swollen44); ESR in mm/hour after 1 hour and the patient’s global disease activity on a Visual Analogue Scale (VAS) of 100 mm (0=no disease activity to right end of the line 100=maximum disease activity) were used to calculate DAS44-ESR using the following formula: DAS44-ESR = 0.54*sqrt(RAI) + 0.065*(swollen44) + 0.33*ln(ESR) + 0.0072*VAS. Lower numbers were better. A negative change from Baseline indicated improvement.|Baseline and Days 13,27,43,56,71,99 and EOT Up to Day 118|All randomized participants with data available for analysis.||score on a scale||Standard Deviation|Mean
839314|NCT01317797|Secondary|Percentage of Participants With American College of Rheumatology (ACR 20) Response|ACR20 response is defined as a ≥ 20% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient’s Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient’s Global Assessment of Disease Activity and Physician’s Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant Erythrocyte Sedimentation Rate.|Baseline and Days 13,27,43,56,71,99 and EOT Up to Day 118|All randomized participants with data available for analysis.||percentage of participants|||Number
839315|NCT01317797|Secondary|Number of Participants With Anti-MT203 Antibodies|Serum samples were tested for the presence of anti-MT203 antibodies by a bridging Electro-chemi-luminescent assay (ECL-assay).|From Day 1 Up to Day 118|Safety population included all randomized participants who received study drug.||participants|||Number
839316|NCT01317797|Secondary|Change From Baseline in MT203/GM-CSF Complexes in Plasma|MT203/GM-CSF complexes were analysed using a procedure that quantified GM-CSF after dissociation from the complex. The determined concentrations corresponded to the amount of total (free and complexed) GM-CSF in the plasma sample. A positive change from Baseline indicated improvement.|Baseline and Days 2, 4, 6, 8 15, 29, 30, 35, 43, 56, 71, 99, EOT Up to Day 118|All randomized participants with data available for analysis.||pg/mL||Standard Deviation|Mean
839317|NCT01317797|Secondary|Change From Baseline in Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in Plasma|MT203/GM-CSF complexes were analysed using a procedure that quantified GM-CSF after dissociation from the complex. The determined concentrations corresponded to the amount of total (free and complexed) GM-CSF in the plasma sample. A positive change from Baseline indicated improvement.|Baseline and Days 2, 4, 6, 8 15, 29, 30, 35, 43, 56, 71, 99, End of trial (EOT) Up to Day 118|All randomized participants with data available for analysis.||pg/mL||Standard Deviation|Mean
839318|NCT01317797|Secondary|Ctrough: Maximum Observed Plasma Concentration Pre-Dose||Days 1, 15 and 29 Pre-dose|PK Analysis set included all 15 participants who were exposed to study drug for whom any PK parameters could be calculated. Method of Dispersion is the 68% range.||μg/mL||Full Range|Geometric Mean
839319|NCT01317797|Secondary|Terminal Phase Elimination Half-life (T1/2) for MT203|Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.|Day 29 (Pre-dose and 2 and 6 hours post-dose)|PK Analysis set included all 15 participants who were exposed to study drug for whom any PK parameters could be calculated.||days||Full Range|Mean
839320|NCT01317797|Secondary|AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for MT203|Area under the plasma concentration-time curve during a dosing interval, where tau is the length of the dosing interval.|Day 29 (Pre-dose and 2 and 6 hours post-dose)|PK Analysis set included all 15 participants who were exposed to study drug for whom any PK parameters could be calculated. Method of Dispersion is the 68% range.||day*μg/mL||Full Range|Geometric Mean
839321|NCT01317797|Secondary|AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for MT203|AUC(0-inf) is measure of area under the curve over the dosing interval (tau) (AUC(0-tau]), where tau is the length of the dosing interval in this study).|Day 29 (Pre-dose and 2 and 6 hours post-dose)|PK Analysis set included all 15 participants who were exposed to study drug for whom any PK parameters could be calculated. Method of Dispersion is the 68% range.||day*μg/mL||Full Range|Geometric Mean
839322|NCT01317797|Secondary|AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for MT203|AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]).|Day 1 and 29 (Pre-dose and 2 and 6 hours post-dose)|PK Analysis set included all 15 participants who were exposed to study drug for whom any PK parameters could be calculated. Method of Dispersion is the 68% range.||day*μg/mL||Full Range|Geometric Mean
839323|NCT01317797|Secondary|Cmax: Maximum Observed Plasma Concentration for MT203|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Day 1 and 29 (Pre-dose and 2 and 6 hours post-dose)|PK Analysis set included all 15 participants who were exposed to study drug for whom any PK parameters could be calculated. Method of Dispersion is the 68% range.||μg/mL||Full Range|Geometric Mean
839324|NCT01317797|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for MT203|Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax|Day 1 and 29 (Pre-dose and 2 and 6 hours post-dose)|||days||Full Range|Median
839325|NCT01317797|Primary|Number of Participants Reporting One or More Treatment Emergent Adverse Events|An Adverse Event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|From Day 1 Up to Day 118|Safety population included all randomized participants who received study drug.||participants|||Number
839373|NCT01318122|Secondary|Change From Baseline in Fasting Blood Glucose (Week 16).|The change between the value of fasting blood glucose collected at week 6 and baseline.|Baseline and Week 16.|Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
839328|NCT01317797|Primary|Number of Participants With Clinically Significant Vital Signs|Vital signs included Systolic Blood Pressure (BP), Diastolic BP, body temperature, heart rate. Alert values were: BP systolic > 170 mmHg or < 85 mmHg, BP diastolic > 105 mmHg, Difference BP systolic vs. Baseline (pre-treatment) > 40 mmHg or Pulse rate < 35 bpm or > 120 beats per minute (bpm).|From Day 1 Up to Day 118|Safety population included all randomized participants who received study drug.||participants|||Number
839329|NCT01317797|Primary|Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings|Alert values for ECG were: Heart rate < 35 bpm or > 120 bpm, QTc acc. to Bazett (absolute value)> 500 ms or QTc acc. to Bazett (increase versus Baseline (pre-treatment).|From Day 1 Up to Day 118|Safety population included all randomized participants who received study drug.||participants|||Number
839330|NCT01317797|Primary|Number of Participants With Clinically Significant Clinical Laboratory Results|Blood was collected for Haematology, Chemistry and Coagulation. Urine was collected for Urinalysis. Alert values for laboratory results include the following: Aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT), gamma-glutamyl-transpeptidase (GGT), alkaline phosphatase (AP), total bilirubin (TBil): > 3 times upper limit of normal (ULN). Creatinine and Glucose: > 2 times ULN. Potassium > 6.0 or < 3.0 mmol/L. Haemoglobin: Male < 8.0 ;Female < 7.0 g/dL. Erythrocytes :Male < 3.5 x 10^12/L or > 7 x 10^12/L;Female < 3.0 x 10^12/L or > 6.5 x 10^12/L. White Blood Cells (WBC): < 2.8 x10^9/L or > 16.0 x 10^9/L. Eosinophils > 20 % of cells in the WBC differential. Platelet Count < 75 x 10^9/L or 600 x 10^9/L. No alert values were identified for Coagulation or Urinalysis.|From Day 1 Up to Day 118|Safety population included all randomized participants who received study drug.||participants|||Number
839331|NCT01317901|Primary|Response|Response was assessed by the investigator on the basis of clinical, radiological, and pathological (i.e., bone marrow) criteria, using the IWG criteria (Cheson et al 2007). A CR is a complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A PR is at least a 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase should be observed in the size of other nodes, liver or spleen, and no new sites of disease should be observed.|Day 15 and Day 28 of even-numbered cycles|All treated subjects||participants|||Number
839332|NCT01318070|Primary|Change From Baseline in Glycosylated Hemoglobin (Week 12).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 and glycosylated hemoglobin collected at baseline.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
839333|NCT01318070|Secondary|Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 12).|The change between the value of blood glucose measured by the meal tolerance test collected at week 12 or final visit and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
839334|NCT01318070|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 12).|The change between the value of fasting plasma glucose collected at week 12 or final visit and glycosylated hemoglobin collected at baseline.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
839335|NCT01318070|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 8).|The change between the value of fasting plasma glucose collected at week 8 and glycosylated hemoglobin collected at baseline.|Baseline and Week 8.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
839336|NCT01318070|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 4).|The change between the value of fasting plasma glucose collected at week 4 and glycosylated hemoglobin collected at baseline.|Baseline and Week 4.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
839337|NCT01318070|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 2).|The change between the value of fasting plasma glucose collected at week 2 and glycosylated hemoglobin collected at baseline.|Baseline and Week 2.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
839338|NCT01318070|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 8).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and glycosylated hemoglobin collected at baseline.|Baseline and Week 8.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
839339|NCT01318070|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 4).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 4 and glycosylated hemoglobin collected at baseline.|Baseline and Week 4.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
839374|NCT01318122|Secondary|Change From Baseline in Fasting Blood Glucose (Week 12).|The change between the value of fasting blood glucose collected at week 12 and baseline.|Baseline and Week 12.|Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
839340|NCT01318070|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 2).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 2 and glycosylated hemoglobin collected at baseline.|Baseline and Week 2.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
839341|NCT01318083|Secondary|Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 12).|The change between the value of blood glucose measured by the meal tolerance test collected at week 12 or final visit and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
839342|NCT01318083|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 12).|The change between the value of fasting plasma glucose collected at week 12 or final visit and baseline.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
839343|NCT01318083|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 8).|The change between the value of fasting plasma glucose collected at week 8 and baseline.|Baseline and Week 8.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
839344|NCT01318083|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 4).|The change between the value of fasting plasma glucose collected at week 4 and baseline.|Baseline and Week 4.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
839345|NCT01318083|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 2).|The change between the value of fasting plasma glucose collected at week 2 and baseline.|Baseline and Week 2.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
839346|NCT01318083|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 8).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and glycosylated hemoglobin collected at baseline.|Baseline and Week 8.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
839347|NCT01318083|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 4).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 4 and glycosylated hemoglobin collected at baseline.|Baseline and Week 4.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
839348|NCT01318083|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 2).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 2 and glycosylated hemoglobin collected at baseline.|Baseline and Week 2.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
839349|NCT01318083|Primary|Change From Baseline in Glycosylated Hemoglobin (Week 12).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 or final visit and glycosylated hemoglobin collected at baseline.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
839350|NCT01318109|Secondary|Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 12).|The change between the value of blood glucose measured by the meal tolerance test collected at week 12 or final visit and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
839351|NCT01318109|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 12).|The change between the value of fasting plasma glucose collected at week 12 or final visit and baseline.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
839352|NCT01318109|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 8).|The change between the value of fasting plasma glucose collected at week 8 and baseline.|Baseline and Week 8.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
839353|NCT01318109|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 4).|The change between the value of fasting plasma glucose collected at week 4 and baseline.|Baseline and Week 4.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
839354|NCT01318109|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 2).|The change between the value of fasting plasma glucose collected at week 2 and baseline.|Baseline and Week 2.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
839355|NCT01318109|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 8).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and glycosylated hemoglobin collected at baseline.|Baseline and Week 8.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
839356|NCT01318109|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 4).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 4 and glycosylated hemoglobin collected at baseline.|Baseline and Week 4.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
839357|NCT01318109|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 2).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 2 and glycosylated hemoglobin collected at baseline.|Baseline and Week 2.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
839358|NCT01318109|Primary|Change From Baseline in Glycosylated Hemoglobin (Week 12).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 or final visit and glycosylated hemoglobin collected at baseline.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
839359|NCT01318122|Secondary|Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Final Visit).|The change between the value of blood glucose measured by the meal tolerance test collected at week 52 or end of study and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.|Baseline and Final Visit (up to Week 52).|Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
839360|NCT01318122|Secondary|Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 52).|The change between the value of blood glucose measured by the meal tolerance test collected at week 52 or final visit and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.|Baseline and Week 52.|Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
839361|NCT01318122|Secondary|Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 24).|The change between the value of blood glucose measured by the meal tolerance test collected at week 24 and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.|Baseline and Week 24.|Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
839362|NCT01318122|Secondary|Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 12).|The change between the value of blood glucose measured by the meal tolerance test collected at week 12 and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.|Baseline and Week 12.|Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
839363|NCT01318122|Secondary|Change From Baseline in Fasting Blood Glucose (Final Visit).|The change between the value of fasting blood glucose collected at week 52 or final visit and baseline.|Baseline and Final Visit (up to Week 52).|Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
839364|NCT01318122|Secondary|Change From Baseline in Fasting Blood Glucose (Week 52).|The change between the value of fasting blood glucose collected at week 52 and baseline.|Baseline and Week 52.|Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
839365|NCT01318122|Secondary|Change From Baseline in Fasting Blood Glucose (Week 48).|The change between the value of fasting blood glucose collected at week 48 and baseline.|Baseline and Week 48.|Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
839366|NCT01318122|Secondary|Change From Baseline in Fasting Blood Glucose (Week 44).|The change between the value of fasting blood glucose collected at week 44 and baseline.|Baseline and Week 44.|Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
839367|NCT01318122|Secondary|Change From Baseline in Fasting Blood Glucose (Week 40).|The change between the value of fasting blood glucose collected at week 40 and baseline.|Baseline and Week 40.|Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
839368|NCT01318122|Secondary|Change From Baseline in Fasting Blood Glucose (Week 36).|The change between the value of fasting blood glucose collected at week 36 and baseline.|Baseline and Week 36.|Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
839369|NCT01318122|Secondary|Change From Baseline in Fasting Blood Glucose (Week 32).|The change between the value of fasting blood glucose collected at week 32 and baseline.|Baseline and Week 32.|Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
839376|NCT01318122|Secondary|Change From Baseline in Glycosylated Hemoglobin (Final Visit).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 52 or final visit and glycosylated hemoglobin collected at baseline.|Baseline and Final Visit (up to Week 52).|Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
839377|NCT01318122|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 52).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 52 and glycosylated hemoglobin collected at baseline.|Baseline and Week 52.|Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
839378|NCT01318122|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 48).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 48 and glycosylated hemoglobin collected at baseline.|Baseline and Week 48.|Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
839379|NCT01318122|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 44).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 44 and glycosylated hemoglobin collected at baseline.|Baseline and Week 44.|Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
839380|NCT01318122|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 40).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 40 and glycosylated hemoglobin collected at baseline.|Baseline and Week 40.|Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
839381|NCT01318122|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 36).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 36 and glycosylated hemoglobin collected at baseline.|Baseline and Week 36.|Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
839382|NCT01318122|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 32).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 32 and glycosylated hemoglobin collected at baseline.|Baseline and Week 32.|Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
839383|NCT01318122|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 28).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 28 and glycosylated hemoglobin collected at baseline.|Baseline and Week 28.|Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
839384|NCT01318122|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 24).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 24 and glycosylated hemoglobin collected at baseline.|Baseline and Week 24.|Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
839385|NCT01318122|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 20).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 20 and glycosylated hemoglobin collected at baseline.|Baseline and Week 20.|Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
839386|NCT01318122|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 16).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 16 and glycosylated hemoglobin collected at baseline.|Baseline and Week 16.|Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
839387|NCT01318122|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 12).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 and glycosylated hemoglobin collected at baseline.|Baseline and Week 12.|Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
839388|NCT01318122|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 8).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and glycosylated hemoglobin collected at baseline.|Baseline and Week 8.|Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
839389|NCT01318122|Primary|Number of Participants With Adverse Events.|Treatment-emergent adverse events (TEAE) are adverse events with an onset that occurs after receiving study drug and within 30 days after receiving the last dose of study drug. A TEAE may also be a pre-treatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing.|52 Weeks.|Full Analysis Set was defined as the population of participants randomized in the core phase 2/3 thiazolidine add on study (SYR-322/CCT-004 study; NCT01318070) and received at least 1 dose of the investigational products (SYR-322DB in combination with pioglitazone) for the treatment period.||participants|||Number
839390|NCT01318135|Secondary|Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Final Visit).|The change between the value of blood glucose measured by the meal tolerance test collected at final visit and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.|Baseline and Final Visit (up to Week 52).|Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
839391|NCT01318135|Secondary|Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 52).|The change between the value of blood glucose measured by the meal tolerance test collected at week 52 and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.|Baseline and Week 52.|Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
839392|NCT01318135|Secondary|Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 24).|The change between the value of blood glucose measured by the meal tolerance test collected at week 24 and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.|Baseline and Week 24.|Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
839393|NCT01318135|Secondary|Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 12).|The change between the value of blood glucose measured by the meal tolerance test collected at week 12 and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.|Baseline and Week 12.|Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
839394|NCT01318135|Secondary|Change From Baseline in Fasting Blood Glucose (Final Visit).|The change between the value of fasting blood glucose collected at final visit and baseline.|Baseline and Final Visit (up to Week 52).|Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
839395|NCT01318135|Secondary|Change From Baseline in Fasting Blood Glucose (Week 52).|The change between the value of fasting blood glucose collected at week 52 and baseline.|Baseline and Week 52.|Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
839396|NCT01318135|Secondary|Change From Baseline in Fasting Blood Glucose (Week 48).|The change between the value of fasting blood glucose collected at week 48 and baseline.|Baseline and Week 48.|Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
839397|NCT01318135|Secondary|Change From Baseline in Fasting Blood Glucose (Week 44).|The change between the value of fasting blood glucose collected at week 44 and baseline.|Baseline and Week 44.|Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
839398|NCT01318135|Secondary|Change From Baseline in Fasting Blood Glucose (Week 40).|The change between the value of fasting blood glucose collected at week 40 and baseline.|Baseline and Week 40.|Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
839399|NCT01318135|Secondary|Change From Baseline in Fasting Blood Glucose (Week 36).|The change between the value of fasting blood glucose collected at week 36 and baseline.|Baseline and Week 36.|Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
839400|NCT01318135|Secondary|Change From Baseline in Fasting Blood Glucose (Week 32).|The change between the value of fasting blood glucose collected at week 32 and baseline.|Baseline and Week 32.|Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
839401|NCT01318135|Secondary|Change From Baseline in Fasting Blood Glucose (Week 28).|The change between the value of fasting blood glucose collected at week 28 and baseline.|Baseline and Week 28.|Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
839402|NCT01318135|Secondary|Change From Baseline in Fasting Blood Glucose (Week 24).|The change between the value of fasting blood glucose collected at week 24 and baseline.|Baseline and Week 24.|Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
839403|NCT01318135|Secondary|Change From Baseline in Fasting Blood Glucose (Week 20).|The change between the value of fasting blood glucose collected at week 20 and baseline.|Baseline and Week 20.|Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
839404|NCT01318135|Secondary|Change From Baseline in Fasting Blood Glucose (Week 16).|The change between the value of fasting blood glucose collected at week 6 and baseline.|Baseline and Week 16.|Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
839405|NCT01318135|Secondary|Change From Baseline in Fasting Blood Glucose (Week 12).|The change between the value of fasting blood glucose collected at week 12 and baseline.|Baseline and Week 12.|Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
839406|NCT01318135|Secondary|Change From Baseline in Fasting Blood Glucose (Week 8).|The change between the value of fasting blood glucose collected at week 8 and baseline.|Baseline and Week 8.|Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
839407|NCT01318135|Secondary|Change From Baseline in Glycosylated Hemoglobin (Final Visit).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at final visit and glycosylated hemoglobin collected at baseline.|Baseline and Final Visit (up to 52).|Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
839408|NCT01318135|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 52).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 52 and glycosylated hemoglobin collected at baseline.|Baseline and Week 52.|Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
839409|NCT01318135|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 48).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 48 and glycosylated hemoglobin collected at baseline.|Baseline and Week 48.|Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
839410|NCT01318135|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 44).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 44 and glycosylated hemoglobin collected at baseline.|Baseline and Week 44.|Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
839411|NCT01318135|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 40).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 40 and glycosylated hemoglobin collected at baseline.|Baseline and Week 40.|Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
839412|NCT01318135|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 36).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 36 and glycosylated hemoglobin collected at baseline.|Baseline and Week 36.|Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
839413|NCT01318135|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 32).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 32 and glycosylated hemoglobin collected at baseline.|Baseline and Week 32.|Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
839414|NCT01318135|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 28).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 28 and glycosylated hemoglobin collected at baseline.|Baseline and Week 28.|Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
839415|NCT01318135|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 24).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 24 and glycosylated hemoglobin collected at baseline.|Baseline and Week 24.|Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
839416|NCT01318135|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 20).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 20 and glycosylated hemoglobin collected at baseline.|Baseline and Week 20.|Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
839417|NCT01318135|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 16).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 16 and glycosylated hemoglobin collected at baseline.|Baseline and Week 16.|Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
839418|NCT01318135|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 12).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 and glycosylated hemoglobin collected at baseline.|Baseline and Week 12.|Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
839419|NCT01318135|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 8).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and glycosylated hemoglobin collected at baseline.|Baseline and Week 8.|Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
839420|NCT01318135|Primary|Number of Participants With Adverse Events.|Treatment-emergent adverse events (TEAE) are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug. A TEAE may also be a pretreatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing.|52 Weeks.|Full Analysis Set was defined as the population of participants randomized in the core phase 2/3 SYR-322/CCT-005 (NCT01318083) or SYR-322/CCT-006 (NCT01318109) add-on studies and received at least 1 dose of the investigational products (SYR-322DB in combination with glimepiride or metformin) for the treatment period were identified for analysis.||participants|||Number
839421|NCT01318278|Secondary|All Cause Mortality||admission to hospital discharge, up to 15 months|||participants|||Number
839422|NCT01318278|Secondary|Neurodevelopmental Outcomes||hospital discharge to follow up at 18-24 months of age||||||
839423|NCT01318278|Secondary|Presence of Bronchopulmonary Dysplasia (BPD)|Infants were evaluated for oxygen need at 36 weeks postmenstrual age. If they required supplemental oxygen, they were diagnosed with BPD|36 weeks postmenstrual age|||participants|||Number
839424|NCT01318278|Secondary|Retinopathy of Prematurity Stage 3 or Higher|"All subjects were followed by an ophthalmologist with initial exam at 4-6 weeks of age. The Stages describe the ophthalmoscopic findings at the junction between the vascularized and avascular retina. Each subject is followed until cleared by ophthalmology. For this outcome measure, the most severe stage of disease was used in analysis.
Stage 1 is a faint demarcation line. Stage 2 is an elevated ridge. Stage 3 is extraretinal fibrovascular proliferation (neovascularization). Stage 4 is sub-total retinal detachment. Stage 5 is total retinal detachment. Stages 1 and 2 do not lead to blindness. However, they can progress to the more severe stages."|Until hospital discharge, up to 15 months|||participants|||Number
839425|NCT01318278|Secondary|Grade 3 Intraventricular Hemorrhage or Worse on Head Ultrasound||Until hospital discharge, up to 15 months|||participants|||Number
839426|NCT01318278|Secondary|Presence of Patent Ductus Arteriosus (PDA)||until hospital discharge, up to 12 weeks|||participants|||Number
839427|NCT01318278|Secondary|Ventilator Days||Until hospital discharge, up to 15 months|||days||Inter-Quartile Range|Median
839428|NCT01318278|Secondary|Necrotizing Enterocolitis||until hospital discharge, up to 12 weeks|||participants|||Number
839429|NCT01318278|Secondary|Evidence of Ischemic Changes|Physical examinations were done on at least a twice daily basis to evaluate for any ischemic lesions (especially on the limbs) of all subjects. The presence of any lesion considered to be due to ischemia would have been reported in this data.|96 hours or until medication completely stopped|||participants|||Number
839430|NCT01318278|Secondary|Urine Output||96 hours or until hypotension resolved and medication completely stopped|||ml/kg/hr||Standard Deviation|Mean
839431|NCT01318278|Secondary|Hyponatremia||96 hours or until medication completely stopped|||participants|||Number
839432|NCT01318278|Secondary|Acid-base Status||96 hours or until hypotension resolved and medication completely stopped|Treatment groups during study drug administration. Comparison group during first 96 hours of life. For all- only arterial gases||pH||Standard Deviation|Mean
839433|NCT01318278|Secondary|Heart Rate Change From Baseline|Heart rate change from baseline during study drug administration|96 hours or until hypotension completely resolved and medications stopped|This outcome is only reportable in the two treatment groups as it evaluates the change in heart rate in those who received study drug. The comparison group infants were not hypotensive within the 24 hours and did not receive study drug, therefore, they are omitted from this outcome measure.||beats per minute||Standard Deviation|Mean
839434|NCT01318278|Primary|Number of Subjects in Each Group Who Have Achieved an Optimal Mean Blood Pressure Value at 24 Hours of Life|Optimal mean blood pressure (OMBP) will be defined as either a 10% increase in mean blood pressure value or a 2-3 mmHg rise in mean blood pressure value AND an improvement in tissue perfusion as demonstrated by a resolution in the specified clinical symptom (designated upon enrollment) within 4-6 hours of having reached OMBP|24 hours of life|This outcome is only reportable in the two treatment groups as it evaluates the response to treatment of hypotension in those who received study drug. The comparison group infants were not hypotensive within the 24 hours and did not receive study drug, therefore, they are omitted from this outcome measure.||participants|||Number
839435|NCT01318382|Secondary|Percentage of Participants With Residual NMB at Various TOF Ratios (<0.6, ≥ 0.6 to <0.7, ≥ 0.7 to <0.8, ≥0.8 to <0.9) Upon Arrival to the PACU|Neuromuscular functioning was monitored at time of PACU arrival by applying three TOF electrical stimulations to the ulnar nerve and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (height) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB, with a higher ratio indicating greater recovery from NMB.|Up to 2 minutes prior to PACU arrival|The PACU Population was defined as all enrolled participants for whom TOF-Watch SX® measurements were collected and had an evaluable TOF Ratio at time of PACU arrival.||percentage of participants||95% Confidence Interval|Number
839436|NCT01318382|Secondary|Percentage of Participants With Residual NMB at Various TOF Ratios (<0.6, ≥0.6 to <0.7, ≥0.7 to <0.8, ≥0.8 to <0.9) at Tracheal Extubation|Neuromuscular functioning was monitored at time of tracheal extubation by applying three TOF electrical stimulations to the ulnar nerve and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (height) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB, with a higher ratio indicating greater recovery from NMB.|Up to 1 minute prior to tracheal extubation|The Per-Protocol Population was defined as all enrolled participants for whom TOF-Watch SX® measurements were collected and had an evaluable TOF Ratio at time of tracheal extubation.||percentage of participants||95% Confidence Interval|Number
839437|NCT01318382|Secondary|Percentage of Participants With Residual NMB (TOF Ratio <0.9) Upon Arrival to the Post-anesthesia Care Unit (PACU)|Neuromuscular functioning was monitored at time of PACU arrival by applying three TOF electrical stimulations to the ulnar nerve and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (height) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB, with a higher ratio indicating greater recovery from NMB. A T4/T1 Ratio of <0.9 is indicative of residual NMB.|Up to 2 minutes prior to PACU arrival|The PACU Population was defined as all enrolled participants for whom TOF-Watch SX® measurements were collected and had an evaluable TOF Ratio at time of PACU arrival.||percentage of participants||95% Confidence Interval|Number
839438|NCT01318382|Primary|Percentage of Participants With Residual Neuromuscular Blockade (NMB)(Train of Four [TOF] Ratio <0.9) at Time of Tracheal Extubation|Neuromuscular functioning was monitored at time of tracheal extubation by applying three TOF electrical stimulations to the ulnar nerve and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (height) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB, with a higher ratio indicating greater recovery from NMB. A T4/T1 Ratio of <0.9 is indicative of residual NMB.|Up to 1 minute prior to tracheal extubation|Per-Protocol Population was defined as all enrolled participants for whom TOF-Watch SX® measurements were collected and had an evaluable TOF Ratio at time of tracheal extubation.||percentage of participants||95% Confidence Interval|Number
839439|NCT01318408|Primary|ADAS-cog at Baseline and at 3 Months.|"ADAScog (Alzheimer's Disease Assessment Scale-cognitive subscale) consists of 11 tasks measuring the disturbances of memory, language, praxis, attention and other cognitive abilities which are often referred to as the core symptoms of AD. Score ranges from 0 - 70.
Lower scores (negative change) indicate improvements on the Alzheimer’s Disease Assessment Scale–Cognitive (ADAS-cog)."|Baseline and Three (3) months|||units on a scale||Standard Deviation|Mean
839440|NCT01318408|Secondary|Several Ratings Such as Activities of Daily Living, Behavior and Motor Activity Will Also be Evaluated.||three months||||||
839441|NCT01318408|Primary|MMSE at Baseline and at Three (3) Months.|The MMSE (Folstein et al 1975) is a brief cognitive test assessing general cognitive function that has been employed in numerous clinical trials of Food and Drug Administration (FDA) products approved for the treatment of AD. The MMSE consists of five components; 1) orientation to time and place, 2) registration of three words, 3) attention and calculation, 4) recall of three words, and 5) language. The scores from each of the five components are summed to obtain the overall MMSE score. The score can range from 0 to 30, with lower scores indicating greater impairment in function.|Baseline and Three months|||units on a scale||Standard Deviation|Mean
839442|NCT01325181|Secondary|Number of Participants With Adverse Event|number of participants with adverse event throughout the follow-up period including procedure and drug-related adverse events|12 months||||||
839443|NCT01325181|Secondary|Number of Participants Who Underwent Rescue Treatment|number of participants who underwent rescue treatment: ranibizumab injections for the low-fluence PDT group and low-fluence PDT for the ranibizumab group|12 months||||||
839444|NCT01325181|Secondary|Change From Baseline in Choroidal Hyperpermeability on Indocyanine Green Angiography|change from baseline in the status of choroidal perfusion and hyperpermeability on indocyanine green angiography throughout the follow-up period|12 months||||||
839445|NCT01325181|Secondary|Number of Participants With Leakage on Fluorescein Angiography|number of participants who showed fluorescein leakage after primary or rescue treatment throughout the follow-up period|12 months||||||
839446|NCT01325181|Secondary|Change From Baseline in Central Foveal Thickness on OCT|the change from baseline in central foveal thickness measured by OCT throughout the follow-up period|12 months||||||
839447|NCT01325181|Primary|Number of Participants That Achieved Complete Resolution of Subretinal Fluid on OCT Without Rescue Treatment|number of participants who achieved complete resolution of subretinal fluid on OCT without rescue treatment until the end of the study|12 months|All study eyes were analyzed using intention to treat principle and the last observation forward method||participants|||Number
839450|NCT01325311|Secondary|Immunohistochemistry Measurements in Prostate Cancer Tissue (PCA)|"The Immunohistochemistry measurement for: AR (Nucleus), VDR (Cytoplasm), p21 (Nucleus), PGE2 (Cytoplasm), TUNEL Pos (Nucleus), Caspase 3 (Cytoplasm), PSMA (Cytoplasm), IGF-1 and IGF-2 (Cytoplasm), Akt (Nucleus and Cytoplasm), and pAkt (nucleus and Cytoplasm)
This is to serve as normalized case data to determine expression of protein.
The normalized optical densities were measured as optical density per unit area by densitometric scanning using Vectra imaging system (Perkin Elmer).
This Optical Density is based on fluorescence."|Up to day Day 35|Due to sample in Arm II one participants data was not analyzed.||Normalized Optical Density||Standard Deviation|Mean
839451|NCT01325311|Secondary|Immunohistochemistry Measurements in Benign Prostate Tissue (BPT)|"The Immunohistochemistry measurement for: AR (Nucleus), VDR (Cytoplasm), p21 (Nucleus), PGE2 (Cytoplasm), TUNEL Pos (Nucleus), Caspase 3 (Cytoplasm), PSMA (Cytoplasm), IGF-1 and IGF-2 (Cytoplasm), Akt (Nucleus and Cytoplasm), and pAkt (nucleus and Cytoplasm)
This is to serve as normalized control data to determine expression of protein.
The normalized optical densities were measured as optical density per unit area by densitometric scanning using Vectra imaging system (Perkin Elmer).
This Optical Density is based on fluorescence."|Up to Day 35|||Normalized Optical Density||Standard Deviation|Mean
839452|NCT01325311|Secondary|Total PTH in Serum at Baseline and Pre-Surgery|This is measuring the concentration of the Biomarker PTH in blood serum at Baseline and at the end of the study|Baseline and Up to Day 35|Due to sample one participant in Arm I was not analyzed.||ng/mL||Standard Deviation|Mean
839453|NCT01325311|Secondary|Total IGFBP-3 in Serum at Baseline and Pre-Surgery|This is measuring the concentration of the Biomarker IGFBP-3 in blood serum at Baseline and at the end of the study.|Baseline and Up to Day 35|Due to sample one participant from Arm 1 was not analyzed.||ng/mL||Standard Deviation|Mean
839454|NCT01325311|Secondary|Total IGF-2 in Serum at Baseline and Pre-Surgery|This is measuring the concentration of the Biomarker IGF-2 in blood serum at Baseline and at the end of the study|Baseline and Up to Day 35|Due to sample one participant in Arm 1 was not analyzed.||ng/mL||Standard Deviation|Mean
839455|NCT01325311|Secondary|Total IGF-1 in Serum at Baseline and Pre-Surgery|This is measuring the concentration of the Biomarker IGF-1 in blood serum at Baseline and at the end of the study.|Baseline and up to Day 35|Due to sample one participant in Arm I was not analyzed for this Outcome.||ng/mL||Standard Deviation|Mean
839456|NCT01325311|Secondary|Serum Calcium Levels at Baseline and Pre-Surgery|This is a measurement of calcium in the Blood serum at baseline and at the end of the study.|Baseline and Day 35|Due to sample one participant in Arm I was not analyzed for this Outcome.||ng/mL (absolute change)||Standard Deviation|Mean
839457|NCT01325311|Secondary|Total PSA in Serum|This is a measure of the concentration of PSA in the blood serum at baseline and at the end of study.|at Baseline and up to Day 35|Due to sample one participant in Arm I was not analyzed for this Outcome.||ng/mL||Standard Deviation|Median
839458|NCT01325311|Secondary|PBMC CYP mRNA Expression of CYP27B1|This is a measure of expression of CYP27B1 in comparing placebo to Cholecalciferol/genistein.|Up to Day 35|||Ratio to Baseline||Standard Deviation|Geometric Mean
839459|NCT01325311|Secondary|PBMC CYP mRNA Expression of CYP24|This is a measure of expression of CYP24 in comparing placebo to Cholecalciferol/genistein.|Baseline and Up to Day 35|Due to sample two participant in Arm I and 2 participants in Arm II were not analyzed for this Outcome.||Ratio to Baseline||Standard Deviation|Geometric Mean
839460|NCT01325311|Secondary|Levels of Calcitriol in Participants Serum|This is measuring the amount of Calcitriol that was found in the participants blood Serum at baseline and end of study.|baseline and Up to Day 35|Due to sample one participant in Arm 1 was not analyzed for this Outcome.||ng/mL||Standard Deviation|Mean
839461|NCT01325311|Primary|Detectability of Calcitriol Levels in Tissue Between the Placebo and Cholecalciferol/Genistein Arms|To identify the amount of Calcitriol that is found in the tissue comparing Placebo and Cholecalciferol/Genistein|up to 35 days|||participants|||Number
839462|NCT01325311|Secondary|Levels of Calcidiol in the Participants Serum|This is measuring the amount of Calcidiol that was found in the participants blood Serum at baseline and end of study|Baseline and up to day 35|Due to sample one participant in Arm 1 was not analyzed for this Outcome.||ng/mL||Standard Deviation|Mean
839463|NCT01325311|Primary|Tissue Levels of Calcitriol Between the Placebo and Cholecalciferol/Genistein Arms|This is a measure of calcitriol in prostate tissue comparing placebo and cholecalciferol/genistein|up to Day 35|||ng/mL||Standard Deviation|Mean
839464|NCT01325337|Secondary|Change From Baseline in Target Area Hair Darkness (TAHD)|Digital imaging analysis was used to measure TAHD. The darkness of all terminal hairs (individual hairs ≥ 30 microns in width) in the target area were summed and divided by total number of terminal hairs in the same target area and was reported as intensity units. A positive change from Baseline indicated improvement (increase in the darkness of terminal hairs).|Baseline, Month 6|Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure.||Intensity units||Standard Deviation|Mean
839465|NCT01325337|Secondary|Change From Baseline in Target Area Hair Width (TAHW)|Digital imaging analysis was used to measure TAHW in millimeters/centimeters squared (mm/cm^2). The diameters of all terminal hairs (individual hairs ≥ 30 microns in width) in the target area were summed and reported together. A positive change from Baseline indicated improvement (increase in the diameter of terminal hairs).|Baseline, Month 6|Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure.||mm/cm^2||Standard Deviation|Mean
839466|NCT01325337|Secondary|Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score|"At the completion of the study, 3 independent dermatologists using the 7-point GPR score compared photographs of the participant's scalp hair growth at Month 6 to Baseline and answered the question: Compared with the baseline image, the amount of the subject’s hair has?: Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented."|Baseline, Month 6|Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure.||Percentage of participants|||Number
839467|NCT01325337|Secondary|Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score|"The investigator compared the participant's scalp hair growth at Month 6 to a photograph of the scalp taken at Baseline and using the 7-point IGA score, the investigator answered the question: Since the start of the study, the amount of the subject’s hair has?: Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented."|Baseline, Month 6|Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure.||Percentage of participants|||Number
839468|NCT01325337|Primary|Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score|"The SSA score measured scalp hair growth. Using a 7-point scale, participants answered the Question: Since the start of the study, the amount of my hair has?: Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented."|Baseline, Month 6|Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure.||Percentage of participants|||Number
839469|NCT01325337|Primary|Change From Baseline in Target Area Hair Count (TAHC)|TAHC was measured using digital imaging analysis and was reported in terminal hairs/centimeters squared (cm^2). A positive change from Baseline indicated improvement (increase in the number of terminal hairs).|Baseline, Month 6|Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure.||terminal hairs/cm^2||Standard Deviation|Mean
839470|NCT01325350|Secondary|Change From Baseline in Target Area Hair Darkness (TAHD)|Digital imaging analysis was used to measure TAHD. The darkness of all terminal hairs (individual hairs ≥ 30 microns) in the target area were summed and divided by total number of terminal hairs in the same target area and was reported as intensity units. A positive change from Baseline indicated improvement (increase in the darkness of terminal hairs).|Baseline, Month 6|Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure.||Intensity units||Standard Deviation|Mean
839471|NCT01325350|Secondary|Change From Baseline in Target Area Hair Width (TAHW)|Digital imaging analysis was used to measure TAHW in millimeters/centimeters squared (mm/cm^2). The diameters of all terminal hairs (individual hairs ≥ 30 microns) in the target area were summed and reported together. A positive change from Baseline indicated improvement (increase in the diameter of terminal hairs). A negative change from Baseline indicated worsening (decrease in the diameter of terminal hairs).|Baseline, Month 6|Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure.||mm/cm^2||Standard Deviation|Mean
839472|NCT01325350|Secondary|Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score|"At the completion of the study, 3 independent dermatologists using the 7-point GPR score compared photographs of the participant's scalp hair growth at Month 6 to Baseline and answered the question: Compared with the baseline image, the amount of the subject’s hair has?: Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented."|Baseline, Month 6|Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure.||Percentage of participants|||Number
839473|NCT01325350|Secondary|Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score|"The investigator compared the participant's scalp hair growth at Month 6 to a photograph of the scalp taken at Baseline and using the 7-point IGA score, the investigator answered the question: Since the start of the study, the amount of the subject’s hair has?: Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented."|Baseline, Month 6|Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure.||Percentage of participants|||Number
839474|NCT01325350|Primary|Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score|"The SSA score measured scalp hair growth. Using a 7-point scale, participants answered the Question: Since the start of the study, the amount of my hair has?: Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented."|Baseline, Month 6|Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure.||Percentage of participants|||Number
839475|NCT01325350|Primary|Change From Baseline in Target Area Hair Count (TAHC)|TAHC was measured using digital imaging analysis and was reported in terminal hairs/centimeters squared (cm^2). A positive change from Baseline indicated improvement (increase in the number of terminal hairs). A negative change from Baseline indicated worsening (decrease in the number of terminal hairs).|Baseline, Month 6|Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure.||terminal hairs/cm^2||Standard Deviation|Mean
839476|NCT01325714|Secondary|Caregiver-perceived Mutuality|"Caregiver-Perceived Total Mutuality (with patient), based on the Mutuality Scale.
Fifteen items about the caregivers' relationship with the patient with dementia were responded to on a 0-4 scale, where 0 = not at all, 1 = a little, 2 = some, 3 = quite a bit, and 4 = a great deal.
responses to all 15 items were averaged, so total scores range from 0-4, with higher values indicating greater mutuality."|Baseline, 3, 6, 12 months|Growth curve models were conducted (n = 203) to examine whether there were treatment group differences in change over time in caregiver-reported mutuality.||units on a scale||Standard Deviation|Mean
839477|NCT01325714|Secondary|Caregiver Burden|"Caregiver-reported burden, according to the Burden Inventory. 22 items are responded to on a 0-4 scale where 0 = never, 1 = rarely, 2 = sometimes, 3 = quite frequently, and 4 = nearly always.
Scores are then summed so that the total range is from 0 to 88. Higher scores indicate greater caregiver burden."|Baseline, 3, 6, 12 months|Growth curve models were conducted (n = 203) to examine whether there were treatment group differences in change over time in caregiver burden.||units on a scale||Standard Deviation|Mean
839478|NCT01325714|Secondary|Pleasant Events - Short Form - Alzheimer's Disease|"The frequency of engagement in pleasant events, according to the Pleasant Events Schedule - Alzheimer's Disease.
For each of 20 events, participants answered the frequency (0 = not at all, 1 = 1-6 times, 2 = 7+ times) they engaged in the event and whether they enjoyed the event (1 = yes, 0 = no).
For each item, frequency x enjoyment were multiplied. Then scores for each of the 20 items were added together.
The possible range of scores on the PES frequency of engagement in pleasant events is from 0 - 40, with higher scores indicating more frequent engagement in pleasant events."|Baseline, 0, 3, 6, 12 months|Growth curve models were conducted (n = 203) to examine whether there were treatment group differences in change over time in frequency of pleasant events.||units on a scale||Standard Deviation|Mean
839479|NCT01325714|Secondary|Depression|"Geriatric Depression Scale. 30 item scale with response options of yes = 1 and no = 0 to each item.
Total GDS scores range from 0 to 30, with greater scores indicating greater depression."|Baseline, 3, 6, and 12 months|Growth curve models were conducted (n = 203) to examine whether there were treatment group differences in change over time in caregiver-reported worst pain.||units on a scale||Standard Deviation|Mean
839480|NCT01325714|Secondary|Patient-reported Overall Pain Over the Last Several Weeks|"This is one item on the Philadelphia Pain Intensity Scale. One item on a 0-5 scale, where 0 = no pain, 1 = little pain, 2= moderate pain, 3 = quite bad pain, 4 = very bad pain, 5 = the pain is almost unbearable.
Higher scores = greater pain severity."|Baseline, 3, 6, and 12 months|Growth curve models were conducted (n = 203) to examine whether there were treatment group differences in change over time in caregiver-reported worst pain.||units on a scale||Standard Deviation|Mean
839481|NCT01325714|Secondary|Caregiver Reported Overall Pain Over the Last Several Weeks|"This is one item on the Philadelphia Pain Intensity Scale. One item on a 0-5 scale, where 0 = no pain, 1 = little pain, 2= moderate pain, 3 = quite bad pain, 4 = very bad pain, 5 = the pain is almost unbearable.
Higher scores = greater pain severity."|Baseline, 3, 6, and 12 months.|Growth curve models were conducted (n = 203) to examine whether there were treatment group differences in change over time in caregiver-reported worst pain.||units on a scale||Standard Deviation|Mean
839482|NCT01325714|Secondary|Patient-reported Worst Pain.|"This is one item on the Philadelphia Pain Intensity Scale. One item on a 0-5 scale, where 0 = no pain, 1 = little pain, 2= moderate pain, 3 = quite bad pain, 4 = very bad pain, 5 = the pain is almost unbearable.
Higher scores = greater pain severity."|Baseline, 3, 6, and 12 months|Growth curve models were conducted (n = 203) to examine whether there were treatment group differences in change over time in patient-reported worst pain.||units on a scale||Standard Deviation|Mean
839483|NCT01325714|Secondary|Caregiver-Reported Worst Pain|"This is one item on the Philadelphia Pain Intensity Scale. One item with scores from 0 to 5, where 0 = no pain, 1 = little pain, 2 = moderate pain, 3 = quite bad pain, 4 = very bad pain, 5 = the pain is almost unbearable.
Higher scores = greater pain severity"|Baseline, 3 months, 6 months, and 12 months|Growth curve models were conducted (n = 203) to examine whether there were treatment group differences in change over time in caregiver-reported worst pain.||units on a scale||Standard Deviation|Mean
839484|NCT01325714|Primary|Number of Participants With Aggression as Determined by the Cohen-Mansfield Agitation Inventory (Aggression Subscale)|"The CMAI lists 13 behaviors (2 verbal and 11 nonverbal) and for each behavior the participant indicates how frequently the behavior occurs (1-5, higher values = greater frequency) and how disruptive the behavior is (1-5, higher values = greater disruptiveness). For any given behavior, if a participant scored a 2 or higher on BOTH frequency (i.e., it occurred less than once a week or more often) and disruptiveness (i.e., it was a little disruptive or more), he/she was considered aggressive.
Overall aggression takes into account all 13 behaviors, whereas verbal aggression only pertains to two behaviors and non-verbal aggression pertains to 11 behaviors.
One is considered verbally aggressive if he/she responds with a 2 or higher on both frequency and disruptiveness for either of the two verbal behaviors.
One is considered non-verbally aggressive if he/she responds with a 2 or higher on both frequency and disruptiveness for any of the 11 non-verbal behaviors."|Three Months, Six Months, Twelve Months Post Intervention|203 community-dwelling Veterans with pain and dementia and their caregivers||participants|||Number
839485|NCT01325792|Secondary|Early and Long-term Complication Rates|Surgical site abdominal wound event rate|after surgery (day 1) to 24 months|||% of subjects with events|||Number
839486|NCT01325792|Primary|Hernia Recurrence Rate|Investigator confirmed hernia recurrence by physical examination|at about 24 months|||% of subjects with recurrent hernia||95% Confidence Interval|Number
839487|NCT01325870|Secondary|Mean Intrathoracic Pressure (Airway Pressure)|Intrathoracic pressures are reported relative to atmospheric pressure|during CPR (day 1)|||mmHg||Standard Deviation|Mean
839488|NCT01325870|Primary|Serious Adverse Events|Serious adverse events include: death, internal thoracic and abdominal injuries, device malfunction preventing use during CPR|during the index CPR procedure (day 1), at hospital discharge, at 30 days, at three months, and at six months of follow-up|||events|||Number
839489|NCT01325870|Primary|Mean Systolic and Diastolic Blood Pressures||during CPR (day 1)|||mmHg||Standard Deviation|Mean
839490|NCT01326026|Secondary|Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Observed rate of nocturnal confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.|Week 0 to Week 26 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product.||Episodes/100 years of patient exposure|||Number
841672|NCT01347255|Primary|Absolute Change in Total Clinical Score (TCS) of Clinical Signs (Sum of Erythema, Scaling and Infiltration) at End of Treatment Compared to Baseline|TCS range from 0 (all signs absent) to 9 (all signs severe).|Day 1 (Baseline)/Day 29|Intra-individual analysis population||Scores on a scale||Standard Deviation|Mean
839491|NCT01326026|Secondary|Rate of Confirmed Hypoglycaemic Episodes|Observed rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 26 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product.||Episodes/100 years of patient exposure|||Number
839492|NCT01326026|Secondary|Rate of Treatment Emergent Adverse Events (AEs)|Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.|Week 0 to Week 26 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product.||Events/100 years of patient exposure|||Number
839493|NCT01326026|Secondary|Change in Fasting Plasma Glucose (FPG)|Change from baseline in FPG after 26 weeks of treatment.|Week 0, Week 26|The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF). For 7 subjects baseline values were missing.||mmol/L||Standard Deviation|Mean
839494|NCT01326026|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Change from baseline in HbA1c after 26 weeks of treatment.|Week 0, Week 26|The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF).||percentage of glycosylated haemoglobin||Standard Deviation|Mean
839495|NCT01326533|Secondary|Beta Cell Function|Change from baseline in the disposition index (DI)|13 weeks after baseline measurement|all randomized with last observation carried forward for missing data||arbitrary units||Standard Error|Mean
839496|NCT01326533|Primary|Insulin Sensitivity|Change from baseline in the insulin sensitivity index (Si)|13 weeks after baseline measurement|all randomized with last observation carried forward for missing data||10^-4/pmol*l/min||Standard Error|Mean
839497|NCT01326845|Secondary|Difference in Reducing Serum Ferritin After Each Month of Study Drug Administration Between the Two Groups|Study was prematurely terminated and not powered for efficacy.|3 months, 6 months||||||
839498|NCT01326845|Secondary|Difference in Severity of GI Symptoms, Bowel Habits and Level of Satisfaction From the Patient's Perspective Between the Two Treatment Groups||3 months, 6 months||||||
839499|NCT01326845|Secondary|the Difference Between the Time From Baseline to the First Occurrence of GI AEs Between the Two Treatment Groups|Study was prematurely terminated and not powered for efficacy.|3 months, 6 months||||||
839500|NCT01326845|Secondary|Difference in Frequency and Severity of All Non-GI AEs Between the Two Treatment Groups|Study was prematurely terminated and not powered for efficacy.|months 3 and 6||||||
839501|NCT01326845|Secondary|Difference in Severity of Specific Commonly Reported GI Symptoms Between the Two Treatment Groups|Study was prematurely terminated and not powered for efficacy.|months 3 and 6||||||
839502|NCT01326845|Secondary|Difference in Severity of Overall GI AEs Between the Two Treatment Groups|Study was prematurely terminated and not powered for efficacy.|months 3 and 6.||||||
839503|NCT01326845|Secondary|Difference in Frequency of Specific Commonly Reported GI AEs Between the Two Treatment Groups|Study was prematurely terminated and not powered for efficacy.|months 3 and 6.||||||
839504|NCT01326845|Secondary|Difference in Frequency of Overall Newly Occurring GI AEs Between the Two Treatment Groups at Month 6.|Study was prematurely terminated and not powered for efficacy.|6 months||||||
839505|NCT01326845|Primary|Difference in the Frequency of Overall Newly Occurring GI Adverse Events (AEs) in the Two Treatment Arms|Study was prematurely terminated and not powered for efficacy. Frequency of GI AEs during the overall study period is available in the AE tables reported in the safety section.|3 months||||||
839506|NCT01326910|Secondary|Investigator's Global Atopic Dermatitis Assessment (IGADA)|An assessment of Atopic Dermatitis based on a 4 point scale where 0 (none) and 3 (severe) are used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating will be 0-clear, 1-almost clear, 2-mild, 3-moderate, 4-severe, or 5-very severe.|through Week 3|Intention to Treat (ITT)||units on a scale||Standard Deviation|Mean
839507|NCT01326910|Secondary|Assessment of Itch|Subject’s or caregiver’s assessment of itch, on a 10-cm Visual Analogue Scale (VAS), where 0-no itch, 10-worst itch imaginable|through Week 3|Intention to Treat (ITT)||units on a scale||Standard Deviation|Mean
839508|NCT01326910|Secondary|Interim Eczema Area and Severity Index (EASI)|Number of subjects improved at Week 2 compared to Baseline in EASI. Improved is defined as post baseline EASI score smaller than baseline score.|Week 2|Intention to Treat||participants|||Number
839509|NCT01326910|Primary|Eczema Area and Severity Index (EASI)|A regional body surface area tabulation based on severity ranging from 0 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72|3 weeks|Intention to Treat (ITT)||units on a scale||Standard Deviation|Mean
839510|NCT01326962|Secondary|Number of Participants With Erythrocyte Sedimentation Rate Abnormality|ESR is an acute phase reactant and is a measure of inflammation. It is measured in millimeter per hour (mm/hr).|Up to 1 year|ITT population consisted of all consented participants enrolled in the study, who had received any part of an infusion of study medication. Where, 'n' = number of participants analyzed at particular point of time.||participants|||Number
839511|NCT01326962|Secondary|Number of Participants With C-Reactive Protein Abnormality|CRP is a biological marker of inflammation. A reduction in CRP indicates improvement. It is measured in milligram per liter (mg/L).|Up to 1 year|ITT population consisted of all consented participants enrolled in the study, who had received any part of an infusion of study medication. Where, 'n' = number of participants analyzed at particular point of time.||mg/L|||Number
839837|NCT01328548|Other Pre-specified|Assessment of Immune Parameters Compatible With Inflammaging: TEMRA Cells|Characterization of Tcell populations will be conducted on whole blood using multiparametric flow cytometry prior to immunization to characterize the immunological function of circulating Tcells in each participant.|Baseline|Data not collected.|||||
839512|NCT01326962|Secondary|Number of Participants Who Achieved ACR20, ACR50, ACR70 and ACR90 Response|ACR20, ACR50, ACR70, and ACR90 are defined as greater than or equal to (≥)20 percent (%), ≥50%, ≥70%, or ≥90% improvement, respectively, in swollen joint count (SJC; 66 joints) and tender joint count (TJC; 68 joints). It also comprises ≥20%, ≥50%, ≥70%, or ≥90% improvement, respectively, in 3 of the following 5 assessments: Patient’s Global Assessment of Pain (VAS); Patient’s Global Assessment of Disease Activity (VAS); Investigator/Physician’s Global Assessment of Disease Activity (VAS); participant’s assessment of disability measured by the Health Assessment Questionnaire Disability Index (HAQ-DI); or acute phase reactant (ESR or C-reactive protein [CRP]).|Up to 1 year|ITT population consisted of all consented participants enrolled in the study, who had received any part of an infusion of study medication. Where, 'n' = number of participants analyzed at particular point of time.||participants|||Number
839513|NCT01326962|Secondary|Number of Participants With AE or SAE Related Discontinuation of Tocilizumab|It included participants who discontinued from the study due to occurrence of AE or SAE.|Up to 1 year|Safety population included all participants who had received at least one dose of study medication.||participants|||Number
839514|NCT01326962|Secondary|Number of Participants With Any Adverse Event and Serious Adverse Event|An adverse event (AE) is defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event.|Up to 1 year|Safety population included all participants who had received at least one dose of study medication.||participants|||Number
839515|NCT01326962|Primary|Change in Fatigue as Measured Using the Fatigue Visual Analog Scale|The VAS for Fatigue (VAS-F) consists of a 100 mm line, with 0 (No Fatigue) on one end, and 100 (Extreme Fatigue) on the other end, which a participant marks to indicate how much fatigue he or she feels. The marked point in mm is converted into a numeric value from 0 to 100, where 0=no fatigue and 100=maximum fatigue. Increasing numbers=increasing fatigue.|Up to 1 year|ITT population consisted of all consented participants enrolled in the study, who had received any part of an infusion of study medication. Where, 'n' = number of participants analyzed at particular point of time.||units on a scale|||Number
839516|NCT01326962|Primary|Changes in Participant’s Fatigue Assessed Using the Mean FACIT-Fatigue Score|The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participants fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score).|Up to 1 year|ITT population consisted of all consented participants enrolled in the study, who had received any part of an infusion of study medication. Where, ‘n’ = number of participants analyzed at particular point of time.||Units on a scale|||Number
839517|NCT01326962|Primary|Number of Participants Who Achieved Clinically Meaningful Health Assessment Questionnaire Response|Health Assessment Questionnaire (HAQ) is a self-completed participant questionnaire specific for Rheumatoid Arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities. Each domain has at least 2 component questions. There are 4 possible responses for each component 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. To calculate HAQ, the participant must have a domain score for at least 6 out of 8 domains. The HAQ is the sum of the scores, divided by the number of domains that have a score (in range 6-8) for a total possible score minimum/maximum 0 (best) to 3 (worst). A negative change from baseline indicated improvement. Clinically meaningful HAQ response was defined as an improvement of at least 0.22 units from baseline in the HAQ Disability Index.|Up to 1 year|ITT population consisted of all consented participants enrolled in the study, who had received any part of an infusion of study medication. Where, 'n' = number of participants analyzed at particular point of time.||participants|||Number
839518|NCT01326962|Primary|Number of Participants Who Achieved Low Disease Activity (DAS28 < 3.2)|DAS28 low disease activity was defined as a DAS28 score reduction of at least 3.2 units from Baseline. The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.|Up to 1 year|ITT population consisted of all consented participants enrolled in the study, who had received any part of an infusion of study medication. Where, 'n' = number of participants analyzed at particular point of time.||participants|||Number
839519|NCT01326962|Primary|Number of Participants Who Achieved a Clinically Meaningful Improvement in DAS28 (Reduction of At Least 1.2 Units)|DAS28 Clinically Significant Improvement was defined as a DAS28 score reduction of at least 1.2 units from Baseline. The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.|Up to 1 year|ITT population consisted of all consented participants enrolled in the study, who had received any part of an infusion of study medication. Where, 'n' = number of participants analyzed at particular point of time.||participants|||Number
839536|NCT01327313|Secondary|Percentage Peak-Trough Fluctuation (PTF)|The peak trough fluctuation over one dosing interval at steady state, calculated as PTF (%) = ( [Cmax - Cmin] / Cav ) multiplied by 100.|Pre-dose, EOI, 4, 8, 24, 48, and 96 hours after start of infusion at Week 5|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797. Here N (number of subjects analyzed) signifies the total number of subjects evaluable for this outcome measure.||percentage fluctuation||Geometric Coefficient of Variation|Geometric Mean
839520|NCT01326962|Primary|Time to Das28 Remission|Time to DAS28 Remission was the Time in days from the first infusion of study drug to the achievement of a DAS28 score < 2.6 units. The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.|Up to 1 year|The intent-to-treat population (ITT) consisted of all consented participants enrolled in the study, who had received any part of an infusion of study medication. Where, 'n' is equal to (=) number of participants analyzed at particular point of time.||Day||Standard Error|Mean
839521|NCT01326962|Primary|Number of Participants Who Achieved Remission (DAS28 < 2.6)|The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.|Up to 1 year|ITT consisted of all consented participants enrolled in the study, who had received any part of an infusion of study medication. Where, 'n' = number of participants analyzed at particular point of time.||participants|||Number
839522|NCT01326962|Primary|Disease Activity as Measured by Disease Activity Score 28 (DAS28)|The DAS28 is a combined index for measuring disease activity in rheumatoid arthritis (RA). The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (erythrocyte sedimentation rate [ESR] in millimeters per hour [mm/hr]), and general health status (participant global assessment of disease activity using visual analog scale [VAS], range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.|Up to 1 year|The intent-to-treat population (ITT) consisted of all consented participants enrolled in the study, who had received any part of an infusion of study medication. Where, 'n' is equal to (=) number of participants analyzed at particular point of time.||units on a scale||Inter-Quartile Range|Median
839523|NCT01327053|Secondary|Complete Response Rate (CRR) Per Central Review - Per FAS|Rate of complete response is the proportion of patients with best overall response of complete response (CR) after starting LDE225 treatment. The rate of CR will be determined according to mRECIST for laBCC and RECIST 1.1 for mBCC. Patients with best overall response of ‘Unknown” will be treated as non responders|6 months|The full analysis set (FAS) comprised all patients who were assigned study treatment irrespective of receiving it (all randomized patients). Patients were classified according to the treatment they were assigned in accordance with the intention-to-treat (ITT) principle.||Percentage of participants||95% Confidence Interval|Number
839524|NCT01327053|Secondary|Complete Response Rate (CRR) Per Central Review - Per pEAS|Rate of complete response is the proportion of patients with best overall response of complete response (CR) after starting LDE225 treatment. The rate of CR will be determined according to mRECIST for laBCC and RECIST 1.1 for mBCC. Patients with best overall response of ‘Unknown” will be treated as non responders|6 months|The primary efficacy analysis set (pEAS) was a subset of the FAS including patients with laBCC with tumors that were adequately assessed by MRI or photography or both, and including all patients with mBCC included in the FAS.||Percentage of participants||95% Confidence Interval|Number
839525|NCT01327053|Secondary|Duration of Response (DoR) Per Central Review Using mRECIST for laBCC and RECIST 1.1 for mBCC Per FAS|"Duration of response is the time from the first observed confirmed response (CR or PR) to disease progression or death due to any reason.
Median DoR for patients with laBCC was non-estimable for both treatment arms. Median DoR was non-estimable for patients with mBCC receiving treatment with sonidegib 200 mg.
Duration of response was for participants with ORR."|6 months|The full analysis set (FAS) comprised all patients who were assigned study treatment irrespective of receiving it (all randomized patients). Patients were classified according to the treatment they were assigned in accordance with the intention-to-treat (ITT) principle.||Months||95% Confidence Interval|Median
839526|NCT01327053|Secondary|Duration of Response (DoR) Per Central Review Using mRECIST for laBCC and RECIST 1.1 for mBCC -Per pEAS|"Duration of response is the time from the first observed confirmed response (CR or PR) to disease progression or death due to any reason.
Median DoR for patients with laBCC was non-estimable for both treatment arms as limited numbers of progressive disease (PD) or deaths were observed as of the 28-Jun-2013 data cut-off date. Median DoR was non-estimable for patients with mBCC receiving treatment with sonidegib 200 mg.
Duration of response was for participants with ORR."|6 months|The primary efficacy analysis set (pEAS) was a subset of the FAS including patients with laBCC with tumors that were adequately assessed by MRI or photography or both, and including all patients with mBCC included in the FAS.||Months||95% Confidence Interval|Median
839527|NCT01327053|Primary|Objective Response Rate (ORR) Based on Central Review According to mRECIST (for Locally Advanced Basal Cell Carcinoma (laBCC)) and RECIST 1.1 (Metastatic Basal Cell Carcinoma (mBCC)) Per Primary Efficacy Analysis Set (pEAS)|ORR is the proportion of patient’s objective response (ORR) by 6 months after starting LDE225 treatment. A responder will be defined as a subject with confirmed partial response (PR) or confirmed complete response (CR) 6 months after starting LDE225 treatment.Treatment with sonidegib was to be considered sufficiently efficacious if the observed ORR on any treatment arm at the end of the study was 30% or higher.|6 months|The primary efficacy analysis set (pEAS) was a subset of the FAS including patients with laBCC with tumors that were adequately assessed by magnetic resonance imaging (MRI) or photography or both, and including all patients with mBCC included in the full analysis set (FAS).||Percentage of participants||95% Confidence Interval|Number
839546|NCT01327313|Secondary|Average Serum Concentration at Steady State (Cav)|The Cav was calculated by dividing the area under the serum concentration-time curve within one complete dosing interval (AUCtau) by the dosing interval (2 weeks or 336 hoursi.e. Cav =AUCtau/tau).|Pre-dose, EOI, 4, 8, 24, 48, and 96 hours after start of infusion at Week 5|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797. Here N (number of subjects analyzed) signifies the total number of subjects evaluable for this outcome measure.||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
841673|NCT01347554|Secondary|Any Bleeding||Two year|||participants|||Number
839528|NCT01327053|Primary|Objective Response Rate (ORR) Based on Central Review According to mRECIST (for Locally Advanced Basal Cell Carcinoma (laBCC)) and RECIST 1.1 (Metastatic Basal Cell Carcinoma (mBCC)) Per Full Analysis Set (FAS).|ORR is the proportion of patient’s objective response (ORR) by 6 months after starting LDE225 treatment. A responder will be defined as a subject with confirmed partial response (PR) or confirmed complete response (CR) 6 months after starting LDE225 treatment.Treatment with sonidegib was to be considered sufficiently efficacious if the observed ORR on any treatment arm at the end of the study was 30% or higher.|6 months|The full analysis set (FAS) comprised all patients who were assigned study treatment irrespective of receiving it (all randomized patients). Patients were classified according to the treatment they were assigned in accordance with the intention-to-treat (ITT) principle.||Percentage of participants||95% Confidence Interval|Number
839529|NCT01327300|Secondary|Intestinal Permeability Testing|"Ability of test substances to permeate the intestinal mucosa. The Lactulose/Mannitol test (Genova Diagnostics®, Ashville, NC) directly measures the ability of mannitol and lactulose to permeate the intestinal mucosa. Patient ingests 5 grams of lactulose and 2 grams of mannitol dissolved in a 100 ml of water. Urine is then collected for 24 hours and the ratio of the urinary excretion of lactulose to mannitol is measured. This testing is performed only after completion of each treatment period , after 12 weeks of mesalamine and after 12 weeks of placebo.
Normal ratio of lactulose/mannitol is any value <0.7. An abnormal ratio is defined as >0.7 ratio. The lactulose is measured in the urine as g/kg and the urinary excretion of mannitol is also measures as g/kg."|At the completion of each 12-week treatment period, all of which are during the time period from 03/25/2010 to 02/01/2012 (up to 2 years)|||ratio||Full Range|Mean
839530|NCT01327300|Secondary|Hospital Anxiety and Depression Scale (HADS)|"A questionnaire is given to each patient with scoring done on a Likert scale ranking from 0-42 which combines anxiety and depression scales. Each of these are scored from 0-21 depending on anxiety versus the depression parameters. Comparison of change in HADs after 12 weeks of intervention with either mesalamine or placebo is provided here with only the total value provided-range is from 0-42.
Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 3 with zero being none at all or occasional and 3 as most of the time. The scale used is a Likert scale and therefore the data returned from the HADS is ordinal.
The best score for the HADS therefore is a 0 with the worst score a 42 for combined anxiety and depression scores.
For the subscales of depression and anxiety, the best score is a 0 and the worst is a 21. This data is not provided here.
Data below includes the change from baseline in the HADS scores."|at the time of recruitment and after completion of each 12-week treatment period, all of which are during the time period from 03/25/2010 to 02/01/2012 (up to 2 years)|||units on a scale||Standard Deviation|Mean
839531|NCT01327300|Secondary|IBS - Quality of Life (IBS-QOL)Score.|A questionnaire is given to each patient and was completed at baseline then after 12 weeks of intervention with mesalamine and then placebo in the cross-over study. The IBS-QOL comprises 34 items with 5-point response scales (0 to 4) that cover eight dimensions of HRQL: dysphoria (8 items), interference with activity (7 items), body image (4 items), health worry (3 items),food avoidance (3 items), social reaction (4 items), sexual concerns (2 items) and relationships (3 items). Higher values indicate better HRQL after converting the raw score on the IBS-QOL into 0 to 100 points.|at the time of recruitment and after completion of each 12-week treatment period, all of which are during the time period from 03/25/2010 to 02/01/2012 (up to 2 years)|Data are the mean change in IBS-QOL between baseline and intervention||units on a scale||Standard Deviation|Mean
839532|NCT01327300|Secondary|Functional Bowel Disorder Severity Index (FBDSI)|Subjects rate pain on a standardized scale. This is a standardized test used to evaluate patients with IBS. Baseline values are compared to 12 weeks after mesalamine and 12 weeks after placebo treatments. The FBDSI is score is interpreted as such: Severity of IBS is rated as none (0 points), mild (1-36 points), moderate as 37-110 points and severe as >110 points. Therefore patients can have a score higher than 110.|An FBDSI score is administered at the beginning of each 12-week treatment period (baseline) and at the end of each 12-week treatment period.|Change in Functional Bowel Disorder Severity Index (FBDSI)after 12 weeks of intervention.||units on a scale||Standard Deviation|Mean
839533|NCT01327300|Secondary|Number of Participants Who Had Evidence of Increased Levels of Pathologic Indicators of Colonic Mucosal Inflammation at 12 Weeks Compared to Baseline.|"Colonoscopy/flexible sigmoidoscopy will be performed and mucosal biopsies will be obtained. Each biopsy was stained for activated t lymphocytes, mast cells and eosinophils .
CD117 staining was done for Mast cells. H and E staining was used to identify lymphocytes and eosinophils. Each path specimen was then noted to have increased versus normal number of these inflammatory cells."|For 2 times: First time: at the time of patient recruitment in the study Second time: after the completion of first 12-week treatment period, all of which are during the time period from 02/25/2010 to 02/01/2012 (up to 2 years)|||participants|||Number
839534|NCT01327300|Primary|Changes in GIS Scores Between Baseline and After a 12 Week Intervention With Mesalamine or Placebo|Patients rated the severity of their GI symptoms. The GIS scale goes from 1 to 7 with 1 being the worse and 7 as the best score showing improvement in symptoms. The GIS was performed at week one and at week 12 during each of the interventions. The comparisons below list the mean difference for each intervention from baseline (BL) with standard deviations then we list the p-value for the differences of baseline to intervention are reported using the Mann-Whitney test with a two-tailed p value provided.|Baseline and at 12 weeks post-intervention|The first part of the analysis compares the differences between baseline and mesalamine to baseline and placebo. The P value provided below list the comparison of baseline-placebo to baseline-mesalamine using the Mann-Whitney statistical analysis.||units on a scale||Standard Deviation|Mean
839535|NCT01327313|Secondary|Accumulation Ratio (Rac)|Accumulation ratio for AUC, calculated as area under the serum concentration-time curve within one complete dosing interval at 3rd infusion divided by area under the serum concentration-time curve within one complete dosing interval at 1st infusion.|Pre-dose, end of infusion (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 1 and Week 5|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797. Here N (number of subjects analyzed) signifies the total number of subjects evaluable for this outcome measure.||ratio||Geometric Coefficient of Variation|Geometric Mean
839584|NCT01327508|Primary|Radiation Exposure Measurement|"Radiation exposure measured in two ways:
Whole body badge TLD ring badge"|Intraoperative|Primary endpoint voided. Dosimeters did not capture radiation dose as expected.|||||
839537|NCT01327313|Secondary|Mean Residence Time at Steady State (MRTss)|MRTss = (AUMCtau + tau(AUCinf – AUCtau))/ AUCtau) - T/2, where AUMCtau was the area under the first moment curve within one complete dosing interval and T was the infusion duration. Area under the serum concentration-time curve from time zero to infinity, calculated as AUC0-t + AUCextra. AUCextra represents an extrapolated value obtained by Clast / λz, where Clast is the calculated serum concentration at the last sampling time point at which the measured serum concentration is at or above LLQ and λz is the elimination rate constant.|Pre-dose, EOI, 4, 8, 24, 48, and 96 hours after start of infusion at Week 5|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797. Here N (number of subjects analyzed) signifies the total number of subjects evaluable for this outcome measure.||hour||Geometric Coefficient of Variation|Geometric Mean
839538|NCT01327313|Secondary|Mean Residency Time (MRT0-inf)|MRT0-inf of drug in the body was calculated by dividing the area under the first moment curve from time zero to infinity with area under the first moment curve from time zero to infinity minus half of infusion of duration (MRT0-inf = AUMC0-inf/AUMC0-inf - T/2).|Pre-dose, end of infusion (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 1|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797.||hour||Geometric Coefficient of Variation|Geometric Mean
839539|NCT01327313|Secondary|Volume of Distribution at Steady State (Vss)|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) was the apparent volume of distribution at steady-state.|Pre-dose, EOI, 4, 8, 24, 48, and 96 hours after start of infusion at Week 5|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797. Here N (number of subjects analyzed) signifies the total number of subjects evaluable for this outcome measure.||liter||Geometric Coefficient of Variation|Geometric Mean
839540|NCT01327313|Primary|Apparent Volume of Distribution: After Multiple Dose|Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/(Area under the serum concentration-time curve within one complete dosing interval [AUCtau]* λz) following multiple dose.|Pre-dose, hour 1 (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 5|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797. Here N (number of subjects analyzed) signifies the total number of subjects evaluable for this outcome measure.||liter||Geometric Coefficient of Variation|Geometric Mean
839541|NCT01327313|Primary|Pharmacokinetics of EMD 525797 - Trough Values|The observed serum concentration immediately before next dosing determined directly from the serum concentration-time profile of each subject (= trough concentration).|Pre-dose, hour 1 (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 5|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797. Here N (number of subjects analyzed) signifies the total number of subjects evaluable for this outcome measure.||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
839542|NCT01327313|Primary|Apparent Volume of Distribution (Vz): After Single Dose|Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/AUC0-inf multiplied by elimination rate constant [λz]) following single dose. Area under the serum concentration-time curve from time zero to infinity, calculated (AUC0-inf) as AUC0-t + AUCextra. AUCextra represents an extrapolated value obtained by Clast / λz, where Clast is the calculated serum concentration at the last sampling time point at which the measured serum concentration is at or above LLQ and λz is the elimination rate constant. And the elimination rate constant obtained from linear regression of the terminal phase of the log transformed concentration-time data. A minimum of three points is required to calculate λz.|Pre-dose, hour 1 (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 1|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797.||liter||Geometric Coefficient of Variation|Geometric Mean
839543|NCT01327313|Primary|Total Body Clearance at Steady State (CLss) of EMD 525797|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. CL of drug in serum was calculated as : CL= Dose/ AUC0-inf. Area under the serum concentration-time curve from time zero to infinity (AUC0-inf), calculated as AUC0-t + AUCextra. AUCextra represents an extrapolated value obtained by Clast / λz, where Clast is the calculated serum concentration at the last sampling time point at which the measured serum concentration is at or above LLQ and λz is the elimination rate constant.|Pre-dose, hour 1 (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 5|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797. Here N (number of subjects analyzed) signifies the total number of subjects evaluable for this outcome measure.||liter per hour||Geometric Coefficient of Variation|Geometric Mean
839544|NCT01327313|Secondary|Area Under the Serum Concentration-time Curve Within One Complete Dosing Interval( AUCtau): After Multiple Dose||Pre-dose, EOI, 4, 8, 24, 48, and 96 hours after start of infusion at Week 5|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797. Here N (number of subjects analyzed) signifies the total number of subjects evaluable for this outcome measure.||hour*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
839545|NCT01327313|Secondary|Area Under the Serum Concentration-time Curve Within One Complete Dosing Interval( AUCtau): After Single Dose||Pre-dose, end of infusion (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 1|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797.||hour*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
839596|NCT01327547|Secondary|Time to Development of Grade 3 and Grade 4 ALT Abnormalities at Week 48 Associated With a Change From Baseline ALT >100 IU/L|Time to development of Grade 3 and Grade 4 ALT abnormalities associated with a change from baseline ALT >100 IU/L during the 48-week period. Baseline will be defined as the last measurement prior to Day 1 dosing.|48 weeks|The analysis was performed on the FAS which included participant who had received at least one dose of study drug. For calculating proportions at the analysis timepoint of interest, ie week 48, LOCF was used if the value at that timepoint was missing.||Days|||Number
839547|NCT01327313|Secondary|Observed Serum Concentration Immediately Before Next Dosing (Cpre)|The observed serum concentration immediately before next dosing determined directly from the serum concentration-time profile of each subject (= trough concentration)|Pre-dose, EOI, 4, 8, 24, 48, and 96 hours after start of infusion at Week 5|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797. Here N (number of subjects analyzed) signifies the total number of subjects evaluable for this outcome measure.||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
839548|NCT01327313|Secondary|Minimum Observed Serum Concentration (Cmin) After Multiple Doses|The observed minimum serum concentration determined directly from the serum concentration-time profile of each subject.|Pre-dose, EOI, 4, 8, 24, 48, and 96 hours after start of infusion at Week 5|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797. Here N (number of subjects analyzed) signifies the total number of subjects evaluable for this outcome measure.||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
839549|NCT01327313|Secondary|Elimination Rate Constant ( λ z): After Multiple Dose|The elimination rate constant obtained from linear regression of the terminal phase of the log transformed concentration-time data.|Pre-dose, EOI, 4, 8, 24, 48, and 96 hours after start of infusion at Week 5|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797. Here N (number of subjects analyzed) signifies the total number of subjects evaluable for this outcome measure.||per hour||Geometric Coefficient of Variation|Geometric Mean
839550|NCT01327313|Secondary|Elimination Rate Constant (λz): After Single Dose|The elimination rate constant obtained from linear regression of the terminal phase of the log transformed concentration-time data.|Pre-dose, end of infusion (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 1|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797.||per hour||Geometric Coefficient of Variation|Geometric Mean
839551|NCT01327313|Secondary|Time to Maximum Observed Serum Concentration (Tmax): After Multiple Dose||Pre-dose, EOI, 4, 8, 24, 48, and 96 hours after start of infusion at Week 5|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797. Here N (number of subjects analyzed) signifies the total number of subjects evaluable for this outcome measure.||hour||Full Range|Median
839552|NCT01327313|Secondary|Time to Maximum Observed Serum Concentration (Tmax): After Single Dose||Pre-dose, end of infusion (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 1|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797.||hour||Full Range|Median
839553|NCT01327313|Secondary|Apparent Terminal Half Life (t1/2): After Multiple Dose||Pre-dose, EOI, 4, 8, 24, 48, and 96 hours after start of infusion at Week 5|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797. Here N (number of subjects analyzed) signifies the total number of subjects evaluable for this outcome measure.||hour||Full Range|Median
839554|NCT01327313|Secondary|Apparent Terminal Half Life (t1/2): After Single Dose||Pre-dose, end of infusion (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 1|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797.||hour||Full Range|Median
839555|NCT01327313|Secondary|Progression-free Survival (PFS)|PFS time was defined as the time (in months) from the first dosing date to the date of first documentation of disease progression as reported and documented by the Investigator (i.e. radiological progression per RECIST version 1.0) or death for any cause within 12 weeks after last tumor assessment. Subjects without event are censored on the date of last tumor assessment.|From first dosing date until disease progression or death, maximum up to Week 36|Full analysis set included all subjects who received at least one (non-zero) administration of the trial medication.||months||Full Range|Median
839556|NCT01327313|Secondary|Number of Subjects With Clinical Benefit|Clinical benefit was defined as presence of at least one confirmed CR, PR, or stable disease (SD) lasting at least 12 weeks according to RECIST v1.0. Per RECIST v1.0: CR was defined as disappearance of all target and non-target lesions and normalization of serum levels of tumor markers . PR was defined as >=30% decrease in sum of longest diameters of target lesions taking as reference baseline sum longest diameters associated to non-progressive disease response for non-target lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference smallest sum of longest dimensions since treatment started associated to non-progressive disease response for non-target lesions.|Baseline up to Week 36|Full analysis set included all subjects who received at least one (non-zero) administration of the trial medication.||subjects|||Number
839557|NCT01327313|Secondary|Number of Subjects With Overall Tumor Response|Overall tumor response was defined as the presence of at least one confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0. Complete response was defined as the disappearance of all target and non-target lesions and normalization of serum levels of tumor markers. PR is at least a 30 percent (%) decrease in the sum of the longest diameter (LD) of target lesions, taking as a reference the baseline sum LD.|Baseline up to Week 36|Full analysis set included all subjects who received at least one (non-zero) administration of the trial medication.||subjects|||Number
839558|NCT01327313|Primary|Total Body Clearance (CL) of EMD 525797: After Single Dose|Total body clearance of drug in serum was calculated: as CL= Dose divided by Area under the serum concentration-time curve from time zero to infinity (AUC0-inf).|Pre-dose, hour 1 (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 1|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797.||liter per hour||Geometric Coefficient of Variation|Geometric Mean
839631|NCT01327703|Secondary|Total Weight of Stools|Mean total weight of stools was calculated for Day 12 to Day 15 in first and second treatment periods.|Day 12 up to Day 15 in first and second treatment periods|ITT population included all randomized participants. Here, ‘N’ (number of participants analyzed) signifies those participants who had 1 or more bowel movements over the 72-hour collection period.||gram||Standard Deviation|Mean
839559|NCT01327313|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration(AUC0-t) of EMD 525797: After Multiple Dose|Area under the serum concentration-time curve from time zero to the last sampling time at which the concentration is at or above LLQ.|Pre-dose, hour 1 (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 5|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797. Here N (number of subjects analyzed) signifies the total number of subjects evaluable for this outcome measure.||hour*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
839560|NCT01327313|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration(AUC0-t) of EMD 525797: After Single Dose|Area under the serum concentration-time curve from time zero to the last sampling time at which the concentration is at or above Lower limit of quantification (LLQ).|Pre-dose, hour 1 (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 1|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797.||hour*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
839561|NCT01327313|Primary|Maximum Observed Serum Concentration (Cmax) of EMD 525797:After Multiple Dose||Pre-dose, hour 1 (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 5|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797. Here N (number of subjects analyzed) signifies the total number of subjects evaluable for this outcome measure.||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
839562|NCT01327313|Primary|Maximum Observed Serum Concentration (Cmax): After Single Dose||Pre-dose, hour 1(end of infusion [EOI]), 4, 8, 24, 48, and 96 hours after start of infusion at Week 1|The pharmacokinetic (PK) analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797.||microgram per milliliter (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
839563|NCT01327313|Primary|Number of Subjects With Dose-limiting Toxicities (DLTs)|DLT was defined as any Grade 3 or 4 haematological or non-haematological toxicity occurring at any dose level until the end of Week 4, and suspected to be reasonably related to the investigational medicinal product by the Investigator and/or Sponsor. Toxicities not considered to be DLTs are as follows- Allergic reactions or anaphylaxis; any Grade 3 or 4 out-of-range laboratory values without any clinical correlate, which were reversible within 7 days, unless the Investigator decided this event is clinically significant. For this reason Grade 3 or 4 out-of-range laboratory values must be re-assessed within 7 days. In case the Investigator provides the subject any treatment(s) due to the out-of-range laboratory values, the event was regarded as a DLT.|Baseline up to Week 4|Dose escalation analysis set/DLT analysis set included all subjects who experienced a DLT or subjects who did not experience a DLT and had a relative dose intensity of >= 75 percent (%) during the DLT observation period.||subjects|||Number
839564|NCT01327339|Secondary|Number of Participants With the Indicated Unexpected Adverse Events|An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Unexpected adverse events include those not listed in the approved product information and not described as precautions or warnings.|one month|ITT Population||participants|||Number
839565|NCT01327339|Secondary|Number of Participants With Any Serious Adverse Event|"A serious adverse event is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening , requires hospitalization or results in prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. For a list of all serious adverse events occurring during the course of the study, see the table entitled Serious Adverse Events in the Adverse Event section of the results record."|one month|ITT Population||participants|||Number
839566|NCT01327339|Primary|Number of Participants With Any Adverse Event|An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|one month|Intent-to-Treat (ITT) Population: all participants who had been administered the investigational drug at least once and had completed all safety assessments.||participants|||Number
839567|NCT01327482|Secondary|Plasma Raltegravir Concentrations|Mean trough concentration from all 3 days|7, 14, 21 days|||ng/mL||Standard Deviation|Mean
839568|NCT01327482|Primary|Tissue Raltegravir Concentrations|Mean trough concentration from all three days. Tissue concentrations are measured from cervical biopsy homogenate using a mass-spectroscopy-based method.|7, 14, 21 days|||ng/mL||Standard Deviation|Mean
839569|NCT01327495|Other Pre-specified|Progesterone||12 weeks|||ng/g||Inter-Quartile Range|Median
839570|NCT01327495|Other Pre-specified|Pregnenolone||12 weeks|||ng/g||Inter-Quartile Range|Median
839571|NCT01327495|Other Pre-specified|DHEA||12 weeks|||ng/g||Inter-Quartile Range|Median
839572|NCT01327495|Other Pre-specified|Androsterone||12 weeks|||ng/g||Inter-Quartile Range|Median
839573|NCT01327495|Other Pre-specified|Androstenedione||12 weeks|||ng/g||Inter-Quartile Range|Median
839574|NCT01327495|Other Pre-specified|17-OHP||12 weeks|||ng/g||Inter-Quartile Range|Median
839575|NCT01327495|Other Pre-specified|17-OHPreg||12 weeks|||ng/g||Inter-Quartile Range|Median
839576|NCT01327495|Secondary|International Prostate Symptom Score (IPSS)|IPSS score: 0-7 mildly symptomatic, 8-19 moderately symptomatic, 20-35 severely symptomatic|12 weeks|||units on a scale||Inter-Quartile Range|Median
839577|NCT01327495|Secondary|Prostate Volume||12 weeks|||cm^3||Inter-Quartile Range|Median
839578|NCT01327495|Secondary|Prostate Specific Antigen||12 weeks|||ng/dL||Inter-Quartile Range|Median
839579|NCT01327495|Primary|Prostate Tissue Testosterone Concentrations After Treatment|To measure intraprostatic testosterone levels|12 weeks|||ng/g||Inter-Quartile Range|Median
839580|NCT01327495|Primary|Dihydrotestosterone (DHT)||12 weeks|||ng/mL||Inter-Quartile Range|Median
839581|NCT01327495|Primary|Serum Testosterone||12 weeks|||ng/mL||Inter-Quartile Range|Median
839582|NCT01327495|Primary|Prostate Tissue DHT Concentrations After Treatment|To measure intraprostatic dihydrotestosterone [DHT] levels|12 weeks|||ng/g||Inter-Quartile Range|Median
839583|NCT01327508|Secondary|Distal Locking Time|Distal locking time is defined as the period between successful nail insertion without locking and the confirmation of accurate insertion of both distal screws.|Intraoperative|||minutes||Standard Deviation|Mean
839585|NCT01327547|Secondary|Change From Baseline in the Hepatic Elastography (FibroscanTM) at Week 48|Participants had transient hepatic elastography using FibroScan technology. It rapidly and non invasively measures hepatic tissue stiffness. Through a probe, a low frequency vibration of low amplitude is transmitted to the liver. The velocity of the wave that is generated during the procedure correlates directly with tissue stiffness as it passes through the liver; the harder or stiffer the liver, the faster the shear wave propagates. Results are reported in kilopascals (kPa). A negative change in the fibroscan values (i.e. decrease in liver stiffness) correlates with a decrease in fibrosis and thus improved outcome.|48 weeks|The analysis was performed on the FAS which included participant who had received at least one dose of study drug. For calculating proportions at the analysis timepoint of interest, ie week 48, LOCF was used if the value at that timepoint was missing.||kPa||Standard Deviation|Mean
839586|NCT01327547|Secondary|Change From Baseline in Enhanced Liver Fibrosis (ELF) Test at Week 48|"The markers of fibrosis assessed in this test comprised hyaluronic acid (CHA), tissue inhibitor of metalloproteinase (CTIMP1) and procollagen III N-terminal peptide (CP3NP); these are components of the extracellular matrix and basement sinusoidal membrane of the liver and are elevated during activation of the stellate cell. The ELF tests were performed on an ADVIA Centaur XP and the composite score was calculated as follows: ELF score = 2.278 + 0.851 ln(CHA) + 0.751 ln (CP3NP) + 0.394 ln(CTIMP1).
ELF score < 7.7: no to mild fibrosis; ≥ 7.7 — < 9.8: Moderate fibrosis; ≥ 9.8 — < 11.3: Severe fibrosis; ≥ 11.3: Cirrhosis."|48 weeks|The analysis was performed on the FAS which included participant who had received at least one dose of study drug. For calculating proportions at the analysis timepoint of interest, ie week 48, LOCF was used if the value at that timepoint was missing.||ELF score||Standard Deviation|Mean
839587|NCT01327547|Secondary|Change From Baseline in Plasma Hepatitis B Virus (HBV) DNA at Week 48|Plasma samples were used to determine HBV DNA using the Roche COBAS Taqman HBV assay. Baseline value for HCV RNA/HBV DNA is defined as the pre-dose measurement taken at Day 1 visit.|48 weeks|The analysis was performed on the FAS which included participant who had received at least one dose of study drug. For calculating proportions at the analysis timepoint of interest, ie week 48, LOCF was used if the value at that timepoint was missing.||IU/L||Standard Deviation|Mean
839588|NCT01327547|Secondary|Change From Baseline in Plasma Hepatitis C Virus (HCV) RNA at Week 48|Plasma samples were used to determine HCV RNA using the Roche COBAS Ampliprep/COBAS HCV Taqman assay, RUO version (LOD=15 IU/mL).Baseline value for HCV RNA/HBV DNA is defined as the pre-dose measurement taken at Day 1 visit.|48 weeks|The analysis was performed on the FAS which included participant who had received at least one dose of study drug. For calculating proportions at the analysis timepoint of interest, ie week 48, LOCF was used if the value at that timepoint was missing.||IU/L||Standard Deviation|Mean
839589|NCT01327547|Secondary|Change From Baseline in Markers of Immune Activation: Transforming Growth Factor-beta (TGF Beta) - Week 48|Plasma samples were used to determine markers of immune activation namely TGF beta.|48 weeks|The analysis was performed on the FAS which included participant who had received at least one dose of study drug. For calculating proportions at the analysis timepoint of interest, ie week 48, LOCF was used if the value at that timepoint was missing.||ng/L||Standard Deviation|Mean
839590|NCT01327547|Secondary|Change From Baseline in Markers of Immune Activation: D Dimer - Week 48|Plasma samples were used to determine markers of immune activation namely D-Dimer.|48 weeks|The analysis was performed on the FAS which included participant who had received at least one dose of study drug. For calculating proportions at the analysis timepoint of interest, ie week 48, LOCF was used if the value at that timepoint was missing.||ng/dL||Standard Deviation|Mean
839591|NCT01327547|Secondary|Change From Baseline in Markers of Immune Activation: C-reactive Protein (CRP) - Week 48|Plasma samples were used to determine markers of immune activation namely CRP.|48 weeks|||mg/dL||Standard Deviation|Mean
839592|NCT01327547|Secondary|Change From Baseline in Markers of Immune Activation: CD38 Expression on CD4 and CD8 Cells - Week 48|Plasma samples were used to determine markers of immune activation namely CD38 expression on CD4 and CD8 cells.|48 weeks|The analysis was performed on the FAS which included participant who had received at least one dose of study drug. For calculating proportions at the analysis timepoint of interest, ie week 48, LOCF was used if the value at that timepoint was missing.||cell/mm³||Standard Deviation|Mean
839593|NCT01327547|Secondary|Change From Baseline in CD4+ and CD8+ Cell Counts at Week 48|Immunologic response (magnitude of change in CD4+ and CD8+ cell counts from baseline) was measured. Baseline value for CD4 and CD8 is defined as the pre-dose measurement taken at Day 1 visit.|48 weeks|The analysis was performed on the FAS which included participant who had received at least one dose of study drug. For calculating proportions at the analysis timepoint of interest, ie week 48, LOCF was used if the value at that timepoint was missing.||Cells/µL||Standard Deviation|Mean
839594|NCT01327547|Secondary|Percentage of Participants With Plasma Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Concentration <40 Copies/mL at Week 48|The Food and Drug Administration (FDA’s) snapshot algorithm was used to derive the efficacy endpoint of the proportion of participants with HIV-1 RNA <40 copies/mL at Week 48. This algorithm included the missing data imputation method and used the plasma HIV-1 RNA concentration in the visit window only, followed the “virology-first principle” and considered a participant who had a missing plasma HIV-1 RNA concentration, or switched to a prohibited background anti-retroviral regimen or discontinues from the study or study drug as a failure (MSDF).|48 weeks|The analysis was performed on the FAS which included participant who had received at least one dose of study drug. For calculating proportions at the analysis timepoint of interest, ie week 48, LOCF was used if the value at that timepoint was missing.||Percentage of participants|||Number
839595|NCT01327547|Secondary|Percentage of Participants With Hy's Law Abnormalities at Week 48|Hy’s law was defined as a total bilirubin >2x ULN with a simultaneous ALT or aspartate transaminase (AST)>3x ULN, excluding participants with an alkaline phosphatase>3x ULN|48 weeks|The analysis was performed on the FAS which included participant who had received at least one dose of study drug. For calculating proportions at the analysis timepoint of interest, ie week 48, LOCF was used if the value at that timepoint was missing.||Percentage of participants|||Number
839748|NCT01321723|Secondary|% Change From Baseline in Bone Formation Marker (P1NP) at Week 24||24 weeks from baseline|mITT Population: all subjects who received at least one dose of treatment and at least one post-baseline BMD value. Missing data imputation for patients who completed Week 12 but not the full 24-week period, data was imputed using the LOCF. No data imputation was performed for Week 24, if the Week 12 data was missing.||percentage of change||Standard Deviation|Mean
839597|NCT01327547|Secondary|Percentage of Participants With Grade 3 and Grade 4 ALT Abnormalities Associated With a Change From Baseline ALT >100 IU/L at Week 48|Percentage of participants who had Grade 3 and Grade 4 ALT abnormalities associated with a change from baseline ALT >100 IU/L during the 48-week period. Baseline will be defined as the last measurement prior to Day 1 dosing.|48 weeks|The analysis was performed on the FAS which included participant who had received at least one dose of study drug. For calculating proportions at the analysis timepoint of interest, ie week 48, LOCF was used if the value at that timepoint was missing.||Percentage of participants|||Number
839598|NCT01327547|Secondary|Time to Development of Grade 3 and Grade 4 ALT Abnormalities at Week 48|Time taken in days to development of Grade 3 and Grade 4 ALT abnormalities defined as >5x ULN for subjects whose baseline ALT ≤ULN, or >3.5x baseline for subjects whose baseline ALT >ULN, at Week 48.|48 weeks|The analysis was performed on the FAS which included participant who had received at least one dose of study drug. For calculating proportions at the analysis timepoint of interest, ie week 48, LOCF was used if the value at that timepoint was missing.||Days||95% Confidence Interval|Median
839599|NCT01327547|Primary|Percentage of Participants With Grade 3 and Grade 4 Alanine Aminotransferase (ALT) Abnormalities at Week 48|Percentage of participants with Grade 3 or Grade 4 ALT abnormalities defined as >5x upper limit of normal (ULN) for participants whose baseline ALT ≤ULN, or >3.5x baseline for participants whose baseline ALT >ULN, at Week 48 in the maraviroc arm versus the placebo arm. The baseline was defined as the last measurement prior to Day 1 dosing.|48 weeks|The analysis was performed on the Full Analysis Set (FAS) which included participants who had received at least one dose of study drug. For calculating proportions at the analysis timepoint of interest, ie week 48, last observation carried forward (LOCF) was used if the value at that timepoint was missing.||Percentage of participants|||Number
839600|NCT01327599|Secondary|Mean Change From Baseline in IOP at Week 4 in Subjects Using Ganfort® at Baseline|IOP (fluid pressure in the eye) was measured with Goldmann applanation tonometry. A positive number change from baseline indicates an increase in intraocular pressure, which may be a risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye was chosen as the study eye, and only the study eye was used for analysis.|Week 4|All subjects using Ganfort at baseline who received study medication and attended Week 4 visit.||millimeters mercury (mmHg)||Standard Deviation|Mean
839601|NCT01327599|Secondary|Percentage of Subjects Who Reach Target IOP of ≤ 18 mmHg in Subjects Using Ganfort® at Baseline|IOP (fluid pressure in the eye) was measured with Goldmann applanation tonometry. An increase in intraocular pressure may be a risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye was chosen as the study eye, and only the study eye was used for analysis.|Week 4, Week 12|ITT: All subjects using Ganfort at baseline who received study medication and had at least one on-therapy study visit, minus missing responses.||percentage of participants|||Number
839602|NCT01327599|Secondary|Mean Change From Baseline in Ocular Hyperemia Score at Week 12 in Subjects Using Ganfort® at Baseline|Ocular hyperemia (visible eye redness) was assessed during slit lamp examination and graded on a 5-point scale (0=none, 4=severe). A positive number change from baseline indicates an increase in ocular redness. One eye was chosen as the study eye, and only the study eye was used for analysis.|Week 12|ITT: All subjects using Ganfort at baseline who received study medication and had at least one on-therapy study visit, minus missing responses.||units on a scale||Standard Deviation|Mean
839603|NCT01327599|Secondary|Mean Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Week 12 in Subjects Using Ganfort® at Baseline|The OSDI is a 12-item quality of life questionnaire designed to assess ocular surface symptoms, their severity, and their impact on the subject's ability to function. Each item was scored by the subject on a 0-4 Likert-type scale (0=None, 4=All of the Time), with a resultant overall score of 0-100 (0=no disability, 100=complete disability). A negative number change from baseline represents a perceived improvement in ocular health.|Week 12|ITT: All subjects using Ganfort at baseline who received study medication and had at least one on-therapy study visit, minus missing responses.||Units on a scale||Standard Deviation|Mean
839604|NCT01327599|Primary|Mean Change From Baseline in IOP at Week 12 in Subjects Using Ganfort® at Baseline|IOP (fluid pressure in the eye) was measured with Goldmann applanation tonometry. A positive number change from baseline indicates an increase in intraocular pressure, which may be a risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye was chosen as the study eye, and only the study eye was used for analysis.|Week 12|All subjects using Ganfort at baseline who received study medication and attended Week 12 visit.||millimeters mercury (mmHg)||Standard Deviation|Mean
839605|NCT01327651|Secondary|A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study|Only the listing of drug resistance test by arm among all participants who seroconvert while on study are presented here. See outcome measure 11 for the listing of plasma HIV RNA levels|From Enrollment to week 30 (end of self-administered dosing)|Below, each seroconverted participants' drug resistance test availability was presented. If the number analyzed equal to 0 then it means the resistance test was not done. When the number analyzed equal to 1 and outcome value is 0 then it means no drug resistance was detected, but if the outcome value is 1 then it means drug resistance was detected.||viral load|||Number
839606|NCT01327651|Secondary|A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study|Only the listing of plasma HIV RNA levels among all participants who seroconvert while on study are presented here. See outcome measure 12 for the listing of drug resistance test by arm.|From Enrollment to week 30 (end of self-administered dosing)|Below, each seroconverted participants' plasma HIV RNA levels at all visits with test results are presented||viral load|||Number
839607|NCT01327651|Secondary|A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm|Only the listing of AE related to study product are presented here. See outcome measure 6 for the listing of adverse events (AEs) by grade and arm.|From week 6 (randomization week) to week 30 (end of self-administered dosing)|"Below Number analyzed population only included the participants who had below adverse events, and the number next to it represent the number of participants had the corresponding AE that was related to the study product"||Participants|||Count of Participants
839608|NCT01327651|Secondary|The Proportion of Participants Who Discontinue All PrEP Use Based on Self-report Via CASI or Weekly Interviews||From Week 6 to Week 30|Number of participants had product hold or product discontinuation log||Participants|||Count of Participants
839609|NCT01327651|Secondary|The Percentage of Correctly Timed Adherence (Number of Pills Taken Within the Recommended Time Frame/Number of Pills Recommended) During 24 Weeks of Follow-up Based on Weekly Interviews and Adjusted EDM (Electronic Drug Monitoring) Data||From week 6 (randomization week) to week 30 (end of self-administered dosing)|For Cape Town daily dosing arm, there are originally 60 participants, but 1 participant was later found to be HIV infected on or before randomization visit, which should make this participant not eligible for the study analysis, so we removed this participant from this table. Given this, we left 59 participants in Cape Town daily dosing arm||% of Correctly Timed Adherence|||Number
839610|NCT01327651|Secondary|A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study|Only the cross table between drug resistance by arm are presented here. See outcome measure 11 for the listing of plasma HIV RNA levels, and outcome measure 12 for the listing of drug resistance test by arm among all participants who seroconvert while on study.|From enrollment to week 30 (end of self-administered dosing)|Data is collected for plasma HIV RNA levels among all participants who seroconvert while on study, but this secondary analysis has not been carried out yet, so no outcome measure is presented here||Participants|||Count of Participants
839611|NCT01327651|Secondary|A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm|Only the listing of adverse events (AEs) by grade and arm are presented here. See outcome measure 10 for the listing of AE by relationship to study product|From week 6 (randomization week) to week 30 (end of self-administered dosing)|||Participants|||Count of Participants
839612|NCT01327651|Secondary|Measurement of TFV-DP (Tenofovir Diphosphate) in PBMC (Peripheral Blood Mononuclear Cell)|Below we presented the percentages of total cohort with TFV-DP concentrations consistent with >=2 pills/week in women who also report sex in the last 7 day for each arm. For Cape Town and Bangkok, TFV-DP in PBMC was analyzed, for Harlem site, the TFV-DP in DBS (dried blood spot) was analyzed. Note: PBMC >5.2 fmol/10^6 cells is considered as participants taken >=2 tablets per week; DBS >=326 fmol/punch is considered as participants taken >=2 tablets per week|week 10, 18 and 30, which is 4 weeks, 12 weeks, and 24 weeks after randomization|Note: Not all participants were available to be analyzed at each visits below, this could be due to missed visit, drug concentration was missing, or participants did not report to have any sex in the last 7 days||Participants|||Count of Participants
839613|NCT01327651|Primary|Self-reported Side Effect or Symptom Scores|The self-reported symptom/side effect scores for common symptoms/side effects including headache, dizziness, cramping, abdominal pain, and flatulence. Collected during clinic visits. All the presented numbers are the percent of visits with each side effects|From week 6 (randomization week) to week 30 (end of self-administered dosing)|For Cape Town daily dosing arm, there are originally 60 participants, but 1 participant was later found to be HIV infected on or before randomization visit, which should make this participant not eligible for the study analysis, so we removed this participant from this table. Given this, we left 59 participants in Cape Town daily dosing arm||percent of visits between week 6 to 30|||Number
839614|NCT01327651|Primary|The Total Pills Actually Used Over the Follow-up Period|The total pills actually used over the follow-up period was calculated based on the adjusted electronic and self-reported pill-use data. It could be more or less than required by study design|From week 6 (randomization week) to week 30 (end of self-administered dosing)|For Cape Town daily dosing arm, there are originally 60 participants, but 1 participant was later found to be HIV infected on or before randomization visit, which should make this participant not eligible for the study analysis, so we removed this participant from this table. Given this, we left 59 participants in Cape Town daily dosing arm||Number of pills actually used|||Number
839615|NCT01327651|Primary|The (Minimum) Total Number of Pills Needed for 100% Coverage Over the Follow-up Period (Based on Randomization Arm and Self-reported Sexual History in the Weekly Interviews)|Below I reported the number of sex acts as reported based on the adjusted electronic and self-reported sexual activity data, also the number of pills needed for 100% coverage. 100% coverage means all sex events (excluding oral sex) are “covered”; Note: sex act is considered as “covered” if at least one pill is taken 96 hours prior the sexual activity and at least one additional pill is taken within 24 hours after the sexual activity (same coverage definition for all three arms)|From week 6 (randomization week) to week 30 (end of self-administered dosing)|For Cape Town daily dosing arm, there are originally 60 participants, but 1 participant was later found to be HIV infected on or before randomization visit, which should make this participant not eligible for the study analysis, so we removed this participant from this table. Given this, we left 59 participants in Cape Town daily dosing arm||Number of pills needed for 100% coverage|sexual exposure||Number
839616|NCT01327651|Primary|Proportion of Sexual Exposures Covered by Pre- and Post-exposure Dosing|Coverage will be determined based on the adjusted electronic and self-reported pill-use data. Specifically, a sex act will be considered as “covered” if at least one pill is taken 96 hours prior the sexual activity and at least one additional pill is taken within 24 hours after the sexual activity. If participant only took pill before the sexual activity (within 96 hours), but no pill taken after sexual activity (within 24 hours), then we considered it as pre-exposure covered. likewise, if participant only took pill after sexual activity (within 24 hours), but did not taken pill before sexual activity (within 96 hours), then we considered it as post-exposure covered. If participant did not taken pill before and after sexual activity, then it was considered as not covered. Note that the same pill can be both pre-exposure dose and a post-exposure dose if events are closely spaced. At no time should a participant in the intermittent arm be taking more pills than the daily arm.|From week 6 (randomization week) to week 30 (end of self-administered dosing)|For Cape Town daily dosing arm, there are originally 60 participants, but 1 participant was later found to be HIV infected on or before randomization visit, which should make this participant not eligible for the study analysis, so we removed this participant from this table. Given this, we left 59 participants in Cape Town daily dosing arm||percentage of sexual exposures|sexual exposures||Number
839617|NCT01327677|Other Pre-specified|Mean Fentanyl Consumption|Amount of cumulative fentanyl consumed in mcg|up to 24 hours postoperatively|||micrograms/ hour||Standard Error|Mean
839618|NCT01327677|Secondary|Hypoxia|Defined by minimum oxygen saturation (SaO2)|up to 24 hours postoperatively|||Percent Oxygen Saturation||Standard Error|Mean
839619|NCT01327677|Primary|Respiratory Depression|Defined by maximal End Tidal CO2 (mmHg)|Up to 24 hours postoperatively.|||mmHg||Standard Error|Mean
839620|NCT01327677|Primary|Respiratory Depression|Defined by minimum respiratory rate (breaths/minute).|up to 24 hours postoperatively|||breaths/minute||Standard Error|Mean
839621|NCT01327703|Secondary|Nutritional Status as Assessed by Hematocrit Level|Nutritional status of participants was assessed by determining their hematocrit level. Mean hematocrit level was calculated at end of treatment (within 3 days after Day 15 of first and second treatment periods).|Baseline, end of treatment (within 3 days after Day 15 of first and second treatment periods) or early discontinuation|Safety population included all randomized participants who received at least 1 dose of study drug. Here, 'N' specifies number of participants who were evaluable for this outcome measure.||proportion of hematocrit||Standard Deviation|Mean
839622|NCT01327703|Secondary|Nutritional Status as Assessed by Albumin, Serum Transferrin and Hemoglobin Level|Nutritional status of participants was assessed by determining their albumin, serum transferrin and hemoglobin level. Mean albumin, serum transferrin and hemoglobin level was calculated at end of treatment (within 3 days after Day 15 of first and second treatment periods).|Baseline, end of treatment (within 3 days after Day 15 of first and second treatment periods) or early discontinuation|Safety population included all randomized participants who received at least 1 dose of study drug. Here, 'N' specifies number of participants who were evaluable for this outcome measure and 'n' specifies number of participants who were evaluable for specific categories at each time point for each arm group, respectively.||gram/L (g/L)||Standard Deviation|Mean
839623|NCT01327703|Secondary|Nutritional Status as Assessed by Electrolytes Level|Nutritional status of participants was assessed by determining their electrolytes (sodium, potassium and chloride) level. Mean electrolytes level was calculated at end of treatment (within 3 days after Day 15 of first and second treatment periods).|Baseline, end of treatment (within 3 days after Day 15 of first and second treatment periods) or early discontinuation|Safety population included all randomized participants who received at least 1 dose of study drug. Here, 'N' specifies number of participants who were evaluable for this outcome measure and 'n' specifies number of participants who were evaluable for specific categories at each time point for each arm group, respectively.||millimole/L (mmol/L)||Standard Deviation|Mean
839624|NCT01327703|Secondary|Nutritional Status as Assessed by Body Mass Index (BMI)|Nutritional status of participants was assessed by determining their BMI. BMI was calculated by dividing body weight (kg) by square of height in meter (m). Mean BMI was calculated at end of treatment (within 3 days after Day 15 of first and second treatment periods).|Baseline, end of treatment (within 3 days after Day 15 of first and second treatment periods) or early discontinuation|Safety population included all randomized participants who received at least 1 dose of study drug. Here, 'N' specifies number of participants who were evaluable for this outcome measure.||kg/m^2||Standard Deviation|Mean
839625|NCT01327703|Secondary|Nutritional Status as Assessed by Body Weight|Mean body weight was calculated at end of treatment (within 3 days after Day 15 of first and second treatment periods).|Baseline, end of treatment (within 3 days after Day 15 of first and second treatment periods) or early discontinuation|Safety population included all randomized participants who received at least 1 dose of study drug. Here, 'N' specifies number of participants who were evaluable for this outcome measure.||kg||Standard Deviation|Mean
839626|NCT01327703|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs)|An AE was defined as any untoward medical occurrence regardless of its causal relationship to study drug. A TEAE was defined as any event not present prior to exposure to study drug or any event already present that worsens in either intensity or frequency following exposure to test drug. A SAE was defined as any event that results in death, is immediately life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect or is assessed as medically important.|Baseline up to 30 days after last dose|Safety population included all randomized participants who received at least 1 dose of study medication. Here, ‘N’ (number of participants analyzed) specifies number of participants who were evaluable for this measure.||participants|||Number
839627|NCT01327703|Secondary|Percent Coefficient of Fat Absorption (CFA) Based on Concomitant Use of Proton Pump Inhibitors (PPIs)|Percent CFA was calculated as ([fat intake - fat excretion]/fat intake)*100, determined in the stools which were collected over a 3-day period (Day 12 to morning of Day 15) during each treatment period. Least squares mean percent (%) CFA was calculated for Day 12 to Day 15 in first and second treatment periods. Percent CFA was based on log transformed data. Percent CFA was calculated separately for participants who used and did not use acid suppressing therapy (PPIs) during the study.|Day 12 up to Day 15 in first and second treatment periods|Per protocol population. Here, 'n' specifies number of participants who were evaluable for specific categories for each arm group, respectively.||percent CFA||Standard Error|Least Squares Mean
839628|NCT01327703|Secondary|Percentage of Participants With Abdominal Distension|Abdominal distension is a sense of increased abdominal pressure by the participant that involves an actual measurable change in the circumference of a participant’s abdomen on physical examination. Percentage of participants with abdominal distension was calculated for each treatment period (Day 1 to Day 15).|Day 1 up to Day 15 in first and second treatment periods|ITT population included all randomized participants. Here, ‘N’ specifies number of participants who had abdominal distension assessment at screening and end of specified treatment.||percentage of participants|||Number
839629|NCT01327703|Secondary|Relative Frequency of Days With Abdominal Symptoms|Abdominal symptoms included abdominal pain and flatulence. Symptoms were classified by severity as mild (no impairment of daily activities), moderate (slight impairment of daily activities), or severe (unable to perform daily activities). For each type of abdominal symptom, the relative frequency of days with the symptom for each participant in a treatment period was calculated as the number of days in which the symptom was reported divided by the total number of days in which the abdominal symptom case report form (CRF) was completed. Mean relative frequency of days with abdominal symptoms was calculated during each treatment period (Day 1 to Day 15).|Day 1 up to Day 15 in first and second treatment periods|ITT population included all randomized participants. Here, ‘N’ specifies number of participants who were evaluable for this outcome measure and 'n' specifies the number of participants with at least one report of the symptom at that severity level during a treatment period.||days||Standard Deviation|Mean
839630|NCT01327703|Secondary|Mean Weight Per Stool Sample|Mean weight per stool sample was calculated for Day 12 to Day 15 in first and second treatment periods.|Day 12 up to Day 15 in first and second treatment periods|ITT population included all randomized participants. Here, 'N' (number of participants analyzed) signifies those participants who had 1 or more bowel movements over the 72-hour collection period.||gram||Standard Deviation|Mean
839632|NCT01327703|Secondary|Percentage of Stools With Normal Consistency|Normal consistency of stool was defined as formed hard, normal or soft stool and abnormal consistency was defined as loose and unformed, liquid stool and diarrhea. Percentage of stools with normal consistency of each participant was calculated as the number of stools with normal consistency relative to the total number of stools during the collection period. Mean percentage of stool with normal consistency during the collection period (Day 12 to Day 15 in first and second treatment periods) for total participants was summarized.|Day 12 up to Day 15 in first and second treatment periods|ITT population included all randomized participants. Here, ‘N’ (number of participants analyzed) specify signifies those participants who were evaluable for this outcome measure.||percentage of stools||Standard Deviation|Mean
839633|NCT01327703|Secondary|Mean Daily Number of Stools|Mean daily number of stools of each participant was calculated from frequency of stools by the participant per day. Mean daily number of stools during the collection period (Day 12 to Day 15 in first and second treatment periods) for total participants was summarized.|Day 12 up to Day 15 in first and second treatment periods|Intent-to-treat (ITT) population included all randomized participants. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||stools per day||Standard Deviation|Mean
839634|NCT01327703|Primary|Percent Coefficient of Fat Absorption (CFA)|Percent CFA was calculated as ([fat intake - fat excretion]/fat intake)*100, determined in the stools which were collected over a 3-day period (Day 12 to morning of Day 15) during each treatment period. Least squares mean percent (%) CFA was calculated for Day 12 to Day 15 in first and second treatment periods. Percent CFA was based on log transformed data.|Day 12 up to Day 15 in first and second treatment periods|Per protocol population included all randomized participants who completed both treatment periods and had all bowel movements appropriately collected with no major protocol violations/deviations or other events considered to potentially bias the study evaluations.||percent CFA||Standard Error|Least Squares Mean
839635|NCT01327885|Secondary|Clinical Benefit Rate (CBR)|CBR was defined as the percentage of participants who have best overall response (BOR) of CR, or PR, or duration of stable disease (dSD) greater than or equal to 11 weeks, between Arm A and Arm B. CBR was estimated by treatment arm based on the tumor response evaluation performed by the PI or designee according to RECIST 1.1. CR was defined as disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameter.|From date of treatment start (Day 1) until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice to stop study treatment, or up to data cutoff (02 Jan 2015), for up to approximately 3 years 11 months|FAS (ITT analysis set) included all participants who were randomized.||Percentage of participants||95% Confidence Interval|Number
839636|NCT01327885|Secondary|Progression-Free Rate at 12 Weeks (PFR12wks)|The PFR12wks was defined as the percentage of participants who were still alive without disease progression at 12 weeks from the date of randomization. Tumor assessment by the investigator or designee was based on RECIST criteria 1.1.|From date of treatment start until Week 12|FAS (ITT analysis set) included all participants who were randomized.||Percentage of participants||95% Confidence Interval|Number
839637|NCT01327885|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time from the date of randomization to the date of first documentation of disease progression, or date of death (whichever occurred first). The date of disease progression was defined as the date of radiologic disease progression as assessed by the investigator or designee based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Participants who did not have an event (i.e., participants who were lost to follow-up or who did not progress or die at the date of data cut-off), were censored. Participants who discontinued study treatment without disease progression were censored on the date of their last radiological assessment (scan date).|Randomization (day 1) to the date of first documentation of disease progression, or date of death (whichever occurred first)|FAS (ITT analysis set) included all participants who were randomized.||Months||95% Confidence Interval|Median
839638|NCT01327885|Primary|Overall Survival (OS)|OS was defined as the time in months from the date of treatment start until death, regardless of cause. In the absence of confirmation of death, participants were censored either at the date that participant was last known to be alive or the date of study cut-off, whichever was earlier. Participants who died on the date of randomization had a survival time of 0.5 day. Allocation of randomization numbers were performed based upon the following stratification factors: (a) Histology (ADI or LMS), (b) Region (Region 1: USA and Canada; or Region 2: Western Europe, Australia, Israel; or Region 3: Eastern Europe, Latin America, and Asia), and (c) Number of prior regimens for advanced soft tissue sarcoma (STS) (2 or >2 prior regimens).|From date of treatment start until date of death from any cause, assessed up to data cutoff date (02 Jan 2015), for up to approximately 3 years 11 months|Full analysis set (FAS) (Intent-to-Treat (ITT) analysis set) included all participants who were randomized.||Months||95% Confidence Interval|Median
839639|NCT01327976|Primary|Percentage Responder Rate in the Treatment Arm.|The second co-primary effectiveness endpoint was based on responder rates with the following two requirements: (i) at least 55% of vBloc subjects would achieve a %EWL of at least 20%; and (ii) at least 45% of vBloc subjects would achieve a %EWL of at least 25%.|12 months|||percentage of subjects|||Number
839640|NCT01327976|Primary|Percentage of Excess Weight Loss (EWL) by Body Mass Index (BMI) Method.|Observe at least a 10% greater excess body weight loss (EWL) from randomization with the Maestro System after 12 months of vBloc Therapy compared to Sham by body mass index (BMI) method. (Body mass index is calculated by dividing body weight (kg) by body height (m) squared (BMI=kg/m2)).|12 months|||percentage of excess weight loss||95% Confidence Interval|Mean
839641|NCT01327976|Primary|Percentage of Subjects Experiencing Implant/Revision Procedure, Device or Therapy Related Serious Adverse Events (SAEs).|To demonstrate that the implant/revision procedure, device and therapy related serious adverse event rate in the vBloc group at 12 months post-implant is significantly lower than 15%.|12 months|An intent-to-treat analysis was performed in the vBloc group.||percentage of participants||95% Confidence Interval|Number
839642|NCT01327989|Primary|Incidence of Device-related and Procedure-related Serious Adverse Events (SAEs).|Device-related and procedure-related Serious Adverse Events (SAEs). A clinically significant procedure complication is defined as a decline in NIHSS of ≥4 or access vessel complication requiring surgery or blood transfusion.|90 Days|||percentage of events|||Number
839749|NCT01321723|Secondary|Systemic Absorption of PTH at Week 24|AUC: (PTH analog tablets timepoints - baseline to 5.75 hours) (Forsteo injection timepoints - baseline to 2 hours)|24 weeks|||pg* hr/mL||Standard Deviation|Mean
839643|NCT01327989|Secondary|Immediate Flow Reperfusion|"Immediate reperfusion observed when the Solitaire™ FR device is deployed within the thrombus – Thrombolysis in Cerebral Infarction (TICI) score 2b or 3.
Grade 0- No perfusion Grade 1- Penetration with Minimal Perfusion Grade 2- Partial Perfusion Grade 2a- Only partial filling (<2/3) of the entire vascular territory is visualized Grade 2b - Complete filling of all of the expected vascular territory is visualized, but the filling is slower than normal Grade 3- Complete Perfusion"|procedure|Due to insufficient imaging, the Core Lab was able to evaluated data from 190 subjects.||percentage of participants|||Number
839644|NCT01327989|Secondary|Incidence of Symptomatic Intracranial Hemorrhage|"Symptomatic intracranial hemorrhage, defined as any parenchymal hematoma 1 (PH1), parenchymal hematoma 2 (PH2), intraparenchymal hemorrhage remote from the ischemic field (RIH), intraventricular hemorrhage (IVH), and subarachnoid hemorrhage (SAH) associated with a decline in National Institutes of Health Stroke Scale (NIHSS) ≥ 4 within 24 hrs.
PH1 – Hematoma within ischemic field with some mild space occupying effect but involving ≤ 30% PH2 – Hematoma within ischemic field with space-occupying effect involving > 30% of the infarcted area RIH – Any intraparenchymal hemorrhage remote from the ischemic field IVH – Intraventricular hemorrhage SAH – Subarachnoid hemorrhage"|24 hours|||percentage of particpants|||Number
839645|NCT01327989|Secondary|Rate of Mortality||90 Days|||percentage of particpants|||Number
839646|NCT01327989|Secondary|Rate of Morbidity||90 Days|||percentage of particpants|||Number
839647|NCT01327989|Secondary|Good Neurological Condition|Good neurological outcome (GNO), as defined in the protocol, is a modified Rankin Scale (mRS) score of less than or equal to 2, or National Institutes of Health Stroke Scale (NIHSS) score 0-1, or NIHSS score improvement of 10 points or more from the pre-procedure evaluation|90 Days|Unavailability of data contributed to fewer subjects analyzed compared to the cohort sample size.||percentage of particpants|||Number
839648|NCT01327989|Secondary|Time to Achieve Revascularization - After First Ipsilateral Angiogram to Final Solitaire™ FR Angiogram|"Time after first ipsilateral angiogram to final Solitaire™ FR angiogram with Thrombolysis in Cerebral Infarction (TICI) score 2b or 3 flow
Thrombolysis in Cerebral Infarction (TICI) score
Grade 0- No perfusion Grade 1- Penetration with Minimal Perfusion Grade 2- Partial Perfusion Grade 2a- Only partial filling (<2/3) of the entire vascular territory is visualized Grade 2b - Complete filling of all of the expected vascular territory is visualized, but the filling is slower than normal Grade 3- Complete Perfusion"|During Procedure|Unavailability of data contributed to fewer subjects analyzed compared to the cohort sample size.||Minutes||Standard Deviation|Mean
839649|NCT01327989|Secondary|Time to Achieve Revascularization - Groin Stick to Initial Angiogram and Final Solitaire™ FR Angiogram|"Time from groin stick to initial angiogram and final Solitaire™ FR angiogram with Thrombolysis in Cerebral Infarction (TICI) score 2b or 3 flow
Thrombolysis in Cerebral Infarction (TICI) score
Grade 0- No perfusion Grade 1- Penetration with Minimal Perfusion Grade 2- Partial Perfusion Grade 2a- Only partial filling (<2/3) of the entire vascular territory is visualized Grade 2b - Complete filling of all of the expected vascular territory is visualized, but the filling is slower than normal Grade 3- Complete Perfusion"|During procedure|Unavailability of data contributed to fewer subjects analyzed compared to the cohort sample size.||Minutes||Standard Deviation|Mean
839650|NCT01327989|Primary|Arterial Recanalization of the Occluded Target Vessel Measured by Thrombolysis in Cerebral Infarction (TICI) Score Equal or Superior to 2b Following the Use of the Study Device.|"Thrombolysis in Cerebral Infarction (TICI) score
Grade 0- No perfusion Grade 1- Penetration with Minimal Perfusion Grade 2- Partial Perfusion Grade 2a- Only partial filling (<2/3) of the entire vascular territory is visualized Grade 2b - Complete filling of all of the expected vascular territory is visualized, but the filling is slower than normal Grade 3- Complete Perfusion"|Immediately post procedure|Due to insufficient imaging, the Core Lab was able to evaluate data from 190 subjects.||percentage of particpants|||Number
839651|NCT01328041|Secondary|Number of Participants With the Indicated Fold Increase in DTG FC (Fold Change in IC50 Relative to Wild-type Virus) Between Baseline and the Time of PDVF, as a Measure of Post-Baseline Phenotypic Resistance|The FC in IC50 (50% inhibitory concentration) for DTG relative to wild-type virus was determined for virus isolated at Baseline and at the time of PDVF. The number of participants with the indicated change (ratio) in the two values at the time of PDVF is presented. PDVF is defined as a <0.5 log10 copies/mL decrease in plasma HIV-1 RNA at Day 8 unless the absolute value is <400 copies/mL. PDVF after Day 8 was defined for virological non-response (decrease in plasma HIV-1 RNA of less than 1 log10 copies/mL by Week 16, with subsequent confirmation, unless plasma HIV-1 RNA <400 copies/mL and confirmed plasma HIV-1 RNA levels >=400 copies/mL on or after Week 24) and virological rebound (confirmed rebound in plasma HIV-1 RNA levels to >=400 copies/mL after prior confirmed suppression to <400 copies/mL and confirmed plasma HIV-1 RNA levels >1 log10 copies/mL above the nadir value, where nadir is >=400 copies/mL).|From the day of the first dose of study drug until end of treatment visit for each participant, up to Week 180 (median of 758 days)|PDVF Phenotypic Resistance Populations. Only participants with Baseline DTG IC50 with PDVF who had paired Baseline and time of virological failure samples were considered for analysis.||Participants|||Number
839652|NCT01328041|Secondary|Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Protocol-defined Virologic Failure (PDVF) as a Measure of Genotypic Resistance|An analysis of changes at specific amino acids in the IN coding region associated with resistance to raltegravir, elvitegravir, or DTG was performed at Day 1 and at the time of PDVF. PDVF is a <0.5 log10 copies(c)/mL decrease in plasma HIV-1 RNA at Day 8 unless the absolute value is <400 c/mL. PDVF after Day 8 is defined as virological non-respones (decrease in plasma HIV-1 RNA of <1 log10 c/mL by Week 16, with subsequent confirmation, unless plasma HIV-1 RNA <400 c/mL and confirmed plasma HIV-1 RNA levels >=400 c/mL on or after Week 24) and virological rebound (confirmed rebound in plasma HIV-1 RNA levels to >=400 c/mL after prior confirmed suppression to <400 c/mL and confirmed plasma HIV-1 RNA levels >1 log10 c/mL above the nadir value [nadir: >=400 c/mL]).|From the day of the first dose of study drug until end of treatment visit for each participant, up to Week 180 (median of 758 days)|PDVF Genotypic Resistance Populations: all participants in the ITT-E Population with available on-treatment genotypic resistance data at the time of PDVF. Only participants with Baseline IN mutations with PDVF who had paired Baseline and time of PDVF samples were considered for analysis.||participants|||Number
841674|NCT01347554|Secondary|Stent Thrombosis|Definite and probable stent thrombosis|Two years|||participants|||Number
839653|NCT01328041|Secondary|C0 Assessment of DTG|The plasma DTG concentration immediately prior to dosing at steady state (C0) was assessed at Day 8, Week 4, and Week 24. Blood samples for pharmacokinetic assessments were collected pre-dose and 1-3 hours post-dose on Day 8 and at Week 4 and 4-12 hours post-dose at Week 24. Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Pharmacokinetic Parameter Population.|Day 8, Week 4, and Week 24|Pharmacokinetic (PK) Parameter Population: all participants who received DTG, underwent PK sampling during the study, and provided an evaluable estimate of C0. Only participants with data available at the indicated time points were considered for analysis.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
839654|NCT01328041|Secondary|AUC(0-tau) and AUC(0-24) of DTG|The area under the time concentration curve over the dosing interval (AUC[0-tau]) and from 0 to 24 hours (AUC[0-24]) of DTG was assessed by a population PK modeling approach using pooled DTG PK data from multiple studies. For this study, blood samples for pharmacokinetic assessments were collected pre-dose on Day 8 and at Weeks 4 and 24, at 1-3 hours post-dose on Day 8, and at 1-3 hours or 4-12 hours post-dose at Weeks 4 and 24.|Day 8, Week 4, and Week 24|The Pharmacokinetic (PK) Concentration Population: all subjects who received DTG, had undergone PK sampling during the study, and provided evaluable DTG plasma concentration data.||µg*hour/mL||95% Confidence Interval|Geometric Mean
839655|NCT01328041|Secondary|Cmax and Ctau of DTG|The maximum plasma concentration (Cmax) and the concentration at the end of a dosing interval (Ctau) of DTG were assessed by a population pharmacokinetic (PK) modeling approach using pooled DTG PK data from multiple studies. For this study, blood samples for pharmacokinetic assessments were collected pre-dose on Day 8 and at Weeks 4 and 24, at 1-3 hours post-dose on Day 8, and at 1-3 hours or 4-12 hours post-dose at Weeks 4 and 24.|Day 8, Week 4, and Week 24|The Pharmacokinetic (PK) Concentration Population: all subjects who received DTG, had undergone PK sampling during the study, and provided evaluable DTG plasma concentration data.||Micrograms per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
839656|NCT01328041|Secondary|Number of Participants With HIV-1 Disease Progression (Acquired Immune Deficiency Syndrome [AIDS] or Death)|The number of participants with HIV-1 disease progression (AIDS or death) was assessed per the Centers for Disease Control and Prevention (CDC) 1993 revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescents and adults. The CDC classifies HIV infection as Category A (participants with asymptomatic HIV infection, acute HIV infection with accompanying illness, or persistent generalized lymphadenopathy), Category B (participants with symptomatic non-AIDS condition, i.e., conditions that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or conditions are considered by physicians to have a clinical course or to require management that is complicated by HIV infection), and Category C (includes AIDS indicator conditions as defined by diagnostic or presumptive measures).|From the day of the first dose of study drug until end of treatment visit for each participant, up to Week 180 (median of 758 days)|ITT-E Population||Participants|||Number
839657|NCT01328041|Secondary|Ratio of CD4+/CD8+ Cell Count at Baseline and Weeks 4, 12, 24, and 48|The ratio of CD4+/CD8+ cell count (measured in cells/mm^3) was assessed at Baseline and at Weeks 4, 12, 24, and 48. The ratio was calculated as the CD4+ cell count divided by CD8+ cell count.|Baseline; Weeks 4, 12, 24, and 48|ITT-E Population. Only those participants with data available at the indicated time points were considered for analysis (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT-E Population.||ratio||Inter-Quartile Range|Median
839658|NCT01328041|Secondary|Median Change From Baseline in CD4+ Cell Counts at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and From Week 48 Every 12 Weeks Until Study Completion|Median change from Baseline in CD4+ cell counts was assessed at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, and 180. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; Day 8; Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168 and 180. v|ITT-E Population. Only those participants with data available at the indicated time points were considered for analysis (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT-E Population.||Cells per millimeters cubed (cells/mm^3)||Inter-Quartile Range|Median
839659|NCT01328041|Secondary|Absolute Values for CD4+ Cell Counts at Baseline, Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and 48 and for CD8+ Cell Counts at Baseline and Weeks 4, 12, 24, and 48|Absolute values for CD4+ cell counts were assessed at Baseline, Day 8 and Weeks 4, 8, 12, 16, and 24, and absolute values for CD8+ cell counts were assessed at Baseline and Weeks 4, 12, 24, and 48.|Baseline, Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and 48|ITT-E Population. Only those participants with data available at the indicated time points were considered for analysis (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT-E Population.||Cells per millimeters cubed (cells/mm^3)||Inter-Quartile Range|Median
839660|NCT01328041|Secondary|Mean Change From Baseline in Plasma HIV-1 RNA at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and From Week 48 Every 12 Weeks up to Study Completion|Mean change from Baseline in plasma HIV-1 RNA was assesseed at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, 48 , 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, and 180 using data of the observed cases. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; Day 8; Weeks 4, 8, 12, 16, 24, 32, 40, and From Week 48 Every 12 Weeks up to Study completion (Up to Week 180)|ITT-E Population. Only those participants with data available at the indicated time points were considered for analysis (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT-E Population.||Log10 copies/mL||Standard Deviation|Mean
839661|NCT01328041|Secondary|Number of Participants With Plasma HIV-1 RNA Less Than 400 and 50 Copies/mL From Week 48 Every 12 Weeks up to Study Completion|The number of participants with plasma HIV-1 RNA less than 400 and 50 copies (c)/mL was assessed at Weeks 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168 and 180 using data of observed cases. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|From Week 48 every 12 weeks up to study completion.|ITT-E Population||Participants|||Number
839662|NCT01328041|Secondary|Number of Participants With Plasma HIV-1 RNA Less Than 400 and 50 Copies/mL at Baseline; Day 8; and Weeks 4, 8, 12, 16, 24, 32, 40, and 48|The number of participants with plasma HIV-1 RNA less than 400 and 50 copies (c)/mL at Baseline; Day 8; and Weeks 4, 8, 12, 16, 24, 32, 40 and 48 based on the Food and Drug Administration's Snapshot algorithm was assessed. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (VOI [due to missing data/discontinuation of investigational product prior to the visit window]) as nonresponders, as well as participants who switched their concomitant antiretroviral (ART) prior to the VOI as follows: background ART substitutions not permitted per protocol; background ART substitutions permitted per protocol, however the decision to switch was not documented as being before or at the first on-treatment visit after switching to optimized background regimen (i.e., Week 4) where HIV-1 RNA was assessed. Otherwise, virologic success/failure was to be determined by the last available HIV-1 RNA assessment while the par. was on treatment within the VOI analysis window|Baseline; Day 8; and Weeks 4, 8, 12, 16, 24, 32, 40, and 48|ITT-E Population||participants|||Number
839663|NCT01328041|Primary|Number of Participants With the Maximum Post-Baseline-emergent Hematology Toxicities of the Indicated Grade|The severity of hematology toxicities was graded according to the DAIDS. The DAIDS displays events as Grades 1-5 based on this general guideline: Grade (G) 1, mild; G2, moderate; G3, severe; G4, life threatening; G5, death related to toxicity.|From the day of the first dose of study drug until end of treatment visit for each participant, up to Week 180 (median of 758 days)|Safety Population||Participants|||Number
839664|NCT01328041|Primary|Number of Participants With the Maximum Post-Baseline-emergent Clinical Chemistry Toxicities of the Indicated Grade|The severity of clinical chemistry toxicities was graded according to the DAIDS toxicity scale. The DAIDS displays events as Grades 1-5 based on this general guideline: Grade (G) 1, mild; G2, moderate; G3, severe; G4, life threatening; G5, death related to toxicity.|From the day of the first dose of study drug until end of treatment visit for each participant, up to Week 180 (median of 758 days)|Safety Population||participants|||Number
839665|NCT01328041|Primary|Number of Participants With Adverse Events of the Indicated Severity, Per the Division of Acquired Immune Deficiency Syndrome (DAIDS) Grading Scale|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. AE/SAE severity was graded according to the DAIDS grading scale. The DAIDS displays events as Grades 1-4 based on this general guideline: Grade (G) 1, mild; G2, moderate; G3, severe; G4, potentially life threatening.|From the day of the first dose of study drug until end of treatment visit for each participant, up to Week 180 (median of 758 days)|Safety Population||participants|||Number
839666|NCT01328041|Primary|Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury.|From the day of the first dose of study drug until end of treatment visit for each participant, up to Week 180 (median of 758 days)|Safety Population: all participants who received at least one dose of study drug||participants|||Number
839667|NCT01328041|Primary|Number of Participants With HIV-1 RNA Less Than 50 Copies/mL at Week 48|The number of participants who had viral load <50 copies/mL at Week 48 based on the Food and Drug Administration's Snapshot algorithm was assessed. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (VOI [due to missing data/discontinuation of investigational product prior to the visit window]) as nonresponders, as well as participants who switched their concomitant antiretroviral (ART) prior to the VOI as follows: background ART substitutions not permitted per protocol; background ART substitutions permitted per protocol, however the decision to switch was not documented as being before or at the first on-treatment visit after switching to optimized background regimen (i.e., Week 4) where HIV-1 RNA was assessed. Otherwise, virologic success/failure was to be determined by the last available HIV-1 RNA assessment while the participant was on treatment within the VOI analysis window.|Week 48|ITT-E Population||participants|||Number
839668|NCT01328041|Primary|Number of Participants With HIV-1 RNA Less Than 50 Copies/mL at Week 24|The number of participants who had viral load <50 copies/mL at Week 24 based on the Food and Drug Administration's Snapshot algorithm was assessed. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (VOI [due to missing data/discontinuation of investigational product prior to the visit window]) as nonresponders, as well as participants who switched their concomitant antiretroviral (ART) prior to the VOI as follows: background ART substitutions not permitted per protocol; background ART substitutions permitted per protocol, however the decision to switch was not documented as being before or at the first on-treatment visit after switching to optimized background regimen (i.e., Week 4) where HIV-1 RNA was assessed. Otherwise, virologic success/failure was to be determined by the last available HIV-1 RNA assessment while the participant was on treatment within the VOI analysis window.|Week 24|ITT-E Population||participants|||Number
839669|NCT01328041|Primary|Mean Change From Baseline in Plasma HIV-1 RNA at Day 8|Mean change from Baseline in Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) at Day 8 was calculated as the Day 8 value minus the Baseline value. The last observation was carried forward if a participant had missed the Day 8 visit. The Baseline observation was carried forward if a participant had discontinued the treatment before Day 8. Blood samples for assessment of HIV-1 RNA levels were collected at Baseline and Day 8.|Baseline and Day 8|Intent-to-Treat-Exposed (ITT-E) Population: all participants who received at least one dose of study drug. Only participants who had Day 8 observations were considered for analysis.||log10 copies/milliliter (mL)||Standard Deviation|Mean
839670|NCT01328054|Secondary|Median Time to Cmax (Tmax) and the Time Prior to the First Quantifiable (Non-zero) Lapatinib Plasma Concentration (Tlag) Following the Last (3rd) Lapatinib Dose|For each participant, the time at which Cmax was observed (tmax) was determined directly from the raw concentration-time data. For each participant, the time prior to the first quantifiable (non-zero) concentration (tlag) was determined directly from the raw concentration-time data. Since all participants received 2 doses of study medication prior to the collection of the first (pre-dose) blood sample on Day 4, tlag was expected to be zero. For PK analysis, one blood sample was collected on Day 1 for placebo Baseline. The 24 hour blood sample on Day 2 also served for lapatinib Baseline. Pre-dose blood samples were collected 30 minutes prior to the administration of study medication on Day 2 (placebo) and Day 4 (lapatinib). Serial blood samples were collected on Day 2 (for placebo) and on Day 4 (for lapatinib) at the following post-last-dose time points 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours.|Day 1 pre-dose; on Day 2 (at pre-dose, then 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose), and on Day 4 (at pre-dose, then 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose)|PK Population||Hours||Full Range|Median
839671|NCT01328054|Secondary|Mean Maximum Plasma Concentration (Cmax) and Observed Plasma Concentration at 24 Hours Post-dose (C24) of Lapatinib|The first occurrence of Cmax and C24 was determined directly from the raw concentration-time data. For PK analysis, one blood sample was collected on Day 1 for placebo Baseline. The 24 hour blood sample on Day 2 also served for lapatinib Baseline. Pre-dose blood samples were collected 30 minutes prior to the administration of study medication on Day 2 (placebo) and Day 4 (lapatinib). Serial blood samples were collected on Day 2 (for placebo) and on Day 4 (for lapatinib) at the following post-last-dose time points 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours.|Day1 pre-dose; on Day 2 (at pre-dose, then 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose), and on Day 4 (at pre-dose, then 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose)|PK Population||Nanograms per mL||Geometric Coefficient of Variation|Geometric Mean
839672|NCT01328054|Secondary|Mean Area Under the Plasma Drug Concentration-time Curve (AUC) From Time Zero (Pre-dose) to the Last Time of Quantifiable Concentration (AUC[0-t]) and From Time Zero (Pre-dose) to 24 Hours Post Dose (AUC[0-24]) for Lapatinib|AUC is defined as the area under the lapatinib concentration-time curve as a measure of drug exposure. AUC(0-t) and AUC(0-24) were determined from the plasma concentration-time data using the linear trapezoidal rule for increased concentrations and the logarithmic trapezoidal rule for decreased concentrations. For PK analysis, one blood sample was collected on Day 1 for placebo Baseline. The 24 hour blood sample on Day 2 also served for lapatinib Baseline. Pre-dose blood samples were collected 30 minutes prior to the administration of study medication on Day 2 (placebo) and Day 4 (lapatinib). Serial blood samples were collected on Day 2 (for placebo) and on Day 4 (for lapatinib) at the following post-last-dose time points 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours.|Day 1 pre-dose; on Day 2 (at pre-dose, then 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-last-dose), and on Day 4 (at pre-dose, then 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-last-dose)|Pharmacokinetic (PK) Population: all participants in the ATS Population for whom at least one PK sample was obtained and analyzed. Only participants available at the specified time point (represented as n=X in the category title) were analyzed.||Nanograms hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
839673|NCT01328054|Secondary|Number of Participants With 12-lead ECG Findings at Indicated Time Points|The number of participants with the 12-lead ECG findings normal (NL), abnormal not clinically significant (Abn NCS), and abnormal clinically significant (Abn CS) are reported. Clinical significance was based on the medical and scientific judgement of the investigator or qualified designee. A single safety 12-lead ECG was performed using a standard 12-lead ECG machine at Baseline; on Day 1 (at pre-dose); on Day 2 (at pre-dose, 4, 8, 12 and 24 hours post-last- dose); on Day 4 (at pre-dose, 4, 8, 12 and 24 hours post-last-dose); at the End of Study visit (Day 8-11); and at the post-treatment Follow-up visit (if applicable).|BL;Day 1 (at pre-dose);Day 2 (at pre-dose, 4, 8, 12 and 24 hr post dose);Day 4 (at pre-dose, 4, 8, 12 and 24 hr post dose);End of Study visit (Day 8-11); and Follow-up (within approx 28 days following last dose of study trt [up to end of Study Week 4])|ATS Population. Only participants available at the specified time point (represented as n=X in the category title) were analyzed.||Participants|||Number
839674|NCT01328054|Secondary|Change From Baseline in Heart Rate at the Indicated Time Points|Heart rate were measured at Baseline; on Day 2 (at pre-dose, 4, 8, 12 and 24 hours post dose), and on Day 4 (at pre-dose, 4, 8, 12 and 24 hours post dose. Baseline is defined as the most recent, non-missing value prior to or on the first study treatment dose date. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; on Day 2 (at pre-dose, 4, 8, 12 and 24 hours post dose), and on Day 4 (at pre-dose, 4, 8, 12 and 24 hours post dose|ATS Population. Only participants available at the specified time point (represented as n=X in the category title) were analyzed.||Beats per minute||Standard Deviation|Mean
839675|NCT01328054|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points|Blood pressure measurements included SBP and DBP and were obtained at Baseline; on Day 2 (at pre-dose, 4, 8, 12 and 24 hours post dose), and on Day 4 (at pre-dose, 4, 8, 12 and 24 hours post dose). Baseline is defined as the most recent, non-missing value prior to or on the first study treatment dose date. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; on Day 2 (at pre-dose, 4, 8, 12 and 24 hours post-dose), and on Day 4 (at pre-dose, 4, 8, 12 and 24 hours post-dose)|ATS Population. Only participants available at the specified time point (represented as n=X in the category title) were analyzed.||Millimeter of mercury (mmHg)||Standard Deviation|Mean
839676|NCT01328054|Secondary|Mean Total Neutrophils (ANC [Absolute Neutrophil Count]), Platelets and Leukocyte Count at the Indicated Time Points|Blood samples were collected for the measurement of total neutrophils (ANC), platelets, and leukocyte count at Baseline; Days 5 and 8-11. Baseline was defined as the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date.|Baseline; Day 5 and end of study visit on Day 8-11|ATS Population. Only participants available at the specified time point (represented as n=X in the category title) were analyzed.||10^9 cells per liter (GI/L)||Standard Deviation|Mean
839677|NCT01328054|Secondary|Mean Calcium, Chloride, Carbon Dioxide (CO2), Potassium, Sodium, Magnesium and Urea at the Indicated Time Points|Blood samples were collected for the measurement of calcium, chloride, CO2, potassium, sodium, magnesium and urea at Baseline; at Days 5 and 8-11. Baseline is defined as the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date.|Baseline; Day 5 and end of study visit on Day 8-11|ATS Population. Only participants available at the specified time point (represented as n=X in the category title) were analyzed.||Millimoles per liter (mmol/L)||Standard Deviation|Mean
839678|NCT01328054|Secondary|Mean Direct Bilirubin, Total Bilirubin, and Creatinine at the Indicated Time Points|Blood samples were collected for the measurement of direct bilirubin, total bilirubin, and creatinine at Baseline; Days 5 and 8-11; Baseline is defined as the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date.|Baseline; Day 5 and end of study visit on Day 8-11|ATS Population. Only participants available at the specified time point (represented as n=X in the category title) were analyzed.||Micromoles per liter (µmol/L)||Standard Deviation|Mean
839679|NCT01328054|Secondary|Mean Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST) at the Indicated Time Points|Blood samples were collected for the measurement of ALP, ALT, and AST at Baseline; Days 5 and 8-11. Baseline is defined as the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date.|Baseline; Day 5 and end of study visit on Day 8-11|ATS Population. Only participants available at the specified time point (represented as n=X in the category title) were analyzed.||International units per liter (IU/L)||Standard Deviation|Mean
839680|NCT01328054|Secondary|Mean Albumin, and Hemoglobin at the Indicated Time Points|Blood samples were collected for the measurement of albumin and hemoglobin at Baseline; Days 5 and 8-11. Baseline is defined as the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date.|Baseline; Day 5 and end of study visit on Day 8-11|ATS Population. Only participants available at the specified time point (represented as n=X in the category title) were analyzed.||Grams per liter (g/L)||Standard Deviation|Mean
839681|NCT01328054|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect, or is an important medical eventsthat jeopardizes the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, new primary cancers, liver events, cardiac dysfunction, pneumonitis, and laboratory abnormalities.|From the start of study treatment until follow-up (within approximately 28 days following the last dose of study medication [up to end of Study Week 4])|ATS Population||Participants|||Number
839682|NCT01328054|Secondary|Number of Participants With the Worst-case Post-Baseline 12-lead Holter ECG Findings With Significant ST, T Wave, and U Wave Abnormalities|Abnormal ECG findings or change in ECG morphological patterns were based on the ECG interpretations provided by the ECG core lab. Three replicate Holter ECGs were collected at 30, 15, and 0 minutes prior to the administration of study treatment on Days 1 (Baseline for placebo) and 3 (Baseline for lapatinib) and pre-dose and 1, 2, 3, 4, 6, 8, 10, and 24 hours post dose on Days 2 and 4. The three readings at each time point were averaged prior to any analysis. Baseline is the pre-dose ECGs (triplicate) taken on Day 1 for placebo and Day 3 for lapatinib. The number of participants with the worst-case post-Baseline 12-lead Holter ECG findings with significant ST, T wave, and U wave abnormalities were analyzed.|Baseline (Day1) and pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24-hours post-dose on Day 2 for placebo. Baseline (Day 3) and pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24-hours post-dose on Day 4 for lapatinib.|Pharmacodynamic (PD) Population: all participants from the All Treated Subjects Population (ATS) who completed the ECG acquisition via Holter monitoring of at least one time point on Days 1, 2, 3 and 4.||Participants|||Number
839683|NCT01328054|Secondary|Number of Participants With 12-lead Holter ECG Findings at the Indicated Time Points|The number of participants with 12-lead Holter ECG findings of normal (NL), abnormal not clinically significant (Abn NCS), and abnormal clinically significant (Abn CS) are reported. Abnormal ECG findings or change in ECG morphological patterns were based on the ECG interpretations provided by the ECG core lab. Three replicate 12-lead Holter ECGs were collected at -30, -15, and 0 minutes prior to the administration of study treatment on Days 1 (Baseline for placebo) and 3 (Baseline for lapatinib) and pre-dose and 1, 2, 3, 4, 6, 8, 10,12, and 24 hours post dose on Days 2 and 4. The three readings at each time point were averaged prior to any analysis. Baseline is the pre-dose ECGs (triplicate) taken on Day 1 for placebo and on Day 3 for lapatinib.|Baseline (Day1) and pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24-hours post-dose on Day 2 for placebo. Baseline (Day 3) and pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24-hours post-dose on Day 4 for lapatinib.|Evaluable Population. Only participants available at the specified time point (represented as n=X, X in the category title) were analyzed.||Participants|||Number
839684|NCT01328054|Secondary|Change From Baseline in the Holter ECG Parameters of QT Interval, Corrected QT Interval (QTc), Bazett Corrected QTc Interval (QTcB), Individual-corrected QT Interval (QTcI), RR Interval, PR Interval, and QRS Duration at Indicated Time Points|A Holter monitor is an ambulatory portable device for continuously monitoring the cardiovascular system. Change from Baseline in QT interval, QTc interval, QTcB interval, QTcI interval, RR interval, PR interval, and QRS duration at each time point for lapatinib was assessed in comparison with time-matched placebo. Three replicate ECGs were collected at 30, 15, and 0 minutes prior to the administration of study treatment on Days 1 and 3 and pre-dose and 1, 2, 3, 4, 6, 8, 10, and 24 hours post dose on Days 2 and 4. The three readings at each time point were averaged prior to any analysis. Baseline is the average of the pre-dose ECGs (triplicate) taken on Day 1 for placebo and Day 3 for lapatinib. Change from Baseline was calculated by subtracting the Baseline values from individual post-Baseline values for each time point.|Baseline (Day1) and pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24-hours post-dose on Day 2 for placebo. Baseline (Day 3) and pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24-hours post-dose on Day 4 for lapatinib.|Evaluable Population. Only participants available at the specified time point (represented as n=X, X in the category title) were analyzed.||Milliseconds||Standard Deviation|Mean
839696|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Types of Concomitant Anti-HIV Drugs|Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”. Abbreviations for the following terminologies are used to represent results in below table: NRTIs: Nucleoside Reverse Transcriptase Inhibitors, NNRTIs: Non-Nucleoside Reverse Transcriptase Inhibitors.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.||participants|||Number
839685|NCT01328054|Primary|Treatment Difference in Duration of Cardiac Ventricular Depolarization and Repolarization Interval (QT) in Fridericia-corrected QT Interval (QTcF) Values Between Placebo and Lapatinib 2000mg|A Holter monitor is an ambulatory portable device used for continuously monitoring the cardiovascular system. Three replicate electrocardiograms (ECGs) were collected at 30, 15, and 0 minutes prior to the administration of study treatment (trt) on Days 1 and 3 and pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 2 and 4. The 3 readings at each time point (TP) were averaged prior to any analysis. BL is the average of the pre-dose QTcF values (triplicate) taken on Day 1 for PBO and on Day 3 for LAP. Mean change from BL was calculated by subtracting the BL values from individual QTcF for each TP. BL adjusted mean difference in absolute QTcF between LAB and PBO (trt difference) with the corresponding 90% confidence interval (CI) was estimated for each TP (pre-dose and 1, 2, 3, 4, 6, 8, 10, 12, and 24-hr post-dose). Trt difference analysis was performed by a repeated measures analysis of variance adjusted for trt group, TP, and trt group*TP interaction.|Baseline (BL) (Day1) and pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24-hours (hr) post-dose on Day 2 for placebo (PBO). Baseline (Day 3) and pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24-hours post-dose on Day 4 for lapatinib (LAP).|Evaluable Population: all participants in the All-Treated Subjects (ATS) Population who met the criteria for dosing compliance, ECG acquisition, and Baseline ECG acquisition. The ATS Population is comprised of all participants who received at least one dose of study medication (placebo or lapatinib).||Milliseconds||Standard Error|Least Squares Mean
839686|NCT01328080|Primary|Percentage Change in Total AKN Lesions From Baseline to Week 16.|To determine if treatment of AKN with targeted ultraviolet B radiation will improve the clinical appearance of lesions.|Baseline to Week 16|||percentage of lesion count reduction||Full Range|Mean
839687|NCT01328158|Secondary|Percentage of Participants With Plasma HIV-1 RNA Levels Less Than 400 Copies/Milliliter [mL]) by Duration in Treatment-Experienced Participants|Participants whose number of plasma HIV-1 RNA copies was less than 400 copies/mL after the start of treatment were handled as responders. For subjects with plasma HIV-1 RNA quantified as < 400 copies/mL, the result was recorded as 399 copies/mL.|Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir|Participants who had both a baseline and at least one post-baseline HIV-1 RNA value were included in the effectiveness analysis set.||percentage of participants|||Number
839688|NCT01328158|Secondary|Percentage of Participants With Plasma HIV-1 RNA Levels Less Than 400 Copies/Milliliter [mL]) by Duration in Treatment-Naive Participants|Participants whose number of plasma HIV-1 RNA copies was less than 400 copies/mL after the start of treatment were handled as responders. For subjects with plasma HIV-1 RNA quantified as < 400 copies/mL, the result was recorded as 399 copies/mL.|Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir|Participants who had both a baseline and at least one post-baseline HIV-1 RNA value were included in the effectiveness analysis set.||percentage of participants|||Number
839689|NCT01328158|Secondary|Number of Participants in Each CDC Classification Category of HIV-infection Over Time|CDC Categories include Category A: asymptomatic acute phase, Category B: symptomatic other than A or C, and Category C: having an AIDS-indicator disease.|Up to Month 60 after first dose of Lopinavir/Ritonavir|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.||participants|||Number
839690|NCT01328158|Secondary|Mean HIV RNA Amount in Treatment-Experienced Participants at Each Time Point of Observation|For subjects with plasma HIV-1 RNA quantified as < 400 copies/mL, the result was recorded as 399 copies/mL.|Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir|Participants who had both a baseline and at least one post-baseline HIV RNA value were included in the effectiveness analysis set.||Log10 copies/mL||Standard Deviation|Mean
839691|NCT01328158|Secondary|Mean HIV Ribonucleic Acid (RNA) Amount in Treatment-Naive Participants at Each Time Point of Observation|For subjects with plasma HIV-1 RNA quantified as < 400 copies/mL, the result was recorded as 399 copies/mL.|Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir|Participants who had both a baseline and at least one post-baseline HIV RNA value were included in the effectiveness analysis set.||Log10 copies/mL||Standard Deviation|Mean
839692|NCT01328158|Secondary|Mean CD4 Cell Count in Treatment-Experienced Participants at Each Time Point of Observation||Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir|Participants who had both a baseline and at least one post-baseline CD4 cell count value were included in the effectiveness analysis set.||cells/mm^3||Standard Deviation|Mean
839693|NCT01328158|Secondary|Mean Cluster of Differentiation 4 (CD4) Cell Count in Treatment-Naive Participants at Each Time Point of Observation||Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir|Participants who had both a baseline and at least one post-baseline CD4 cell count value were included in the effectiveness analysis set.||cells/mm^3||Standard Deviation|Mean
839694|NCT01328158|Secondary|Number of Participants With Serious Adverse Events|A serious adverse event is an adverse event that 1. requires in patient hospitalization or prolongation of existing hospitalization, 2. results in persistent or significant disability/incapacity, 3. is life-threatening, 4. results in death, 5. is a congenital anomaly/birth defect, or 6. is an important medical event other than the above.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.||participants|||Number
839695|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Drugs Other Than Anti-HIV Drugs|Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.||participants|||Number
839697|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Anti-HIV Concomitant Non-Drug Treatments|Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.||participants|||Number
839698|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Anti-HIV Concomitant Drugs|Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.||participants|||Number
839699|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Use Duration of Lopinavir/Ritonavir|Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.||participants|||Number
839700|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Mean Daily Dose of Lopinavir/Ritonavir|Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.||participants|||Number
839701|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Administration Method of Lopinavir/Ritonavir|Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.||participants|||Number
839702|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Center for Disease Control (CDC) Classification Category of Severity Before Treatment|Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.||participants|||Number
839703|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Haemophilia With/Without Hepatitis C|Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.||participants|||Number
839704|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Haemophilia|Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.||participants|||Number
839705|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Liver Disorder|Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.||participants|||Number
839706|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Renal Disorder|Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.||participants|||Number
839707|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Diseases|Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.||participants|||Number
839708|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Allergy|Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.||participants|||Number
839709|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Past Medical History|Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months|||participants|||Number
839897|NCT01329939|Secondary|Spirometric Measures|Breathing maneuvers which help to measure obstruction of airways. We did not perform percent change from baseline since in a randomized clinical trial, where the groups are comparable at baseline, we can use only the post-treatment (week 24) data in the analysis.|24 weeks|||percent predicted||95% Confidence Interval|Mean
839710|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Disease Duration|Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.||participants|||Number
839711|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Route of Infection|Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.||participants|||Number
839712|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Races|Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.||participants|||Number
839713|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Previous Treatment of Human Immunodeficiency Virus (HIV)-Infection|Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.||participants|||Number
839714|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Inpatient/Outpatient|Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.||participants|||Number
839715|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Age|Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.||participants|||Number
839716|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Pregnancy|Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months|All female participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.||participants|||Number
839717|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Gender|Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.||participants|||Number
839718|NCT01328158|Primary|Number of Adverse Drug Reactions|Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period..||number of adverse drug reaction|||Number
839719|NCT01328158|Primary|Percentage of Participants With Adverse Drug Reactions|Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.||percentage of participants|||Number
839720|NCT01328184|Secondary|Assessment of Tolerability|Tolerability will be assessed by the investigator according to the categories good, satisfactory, not satisfactory, bad and not assessable.|Within Day 24 to Day 31|Treated set (TS) included all subjects who took at least one dose of study medication.||percentage of participants|||Number
839721|NCT01328184|Secondary|Number of Participants With Clinically Relevant Abnormalities in Physical Examination, Vital Signs, ECG and Clinical Laboratory Tests.|Number of participants with clinically relevant abnormalities in physical examination, vital signs and clinical laboratory tests. Relevant findings or worsenings of baseline conditions were reported as adverse events.|Day 1 to day 17|Treated set (TS) included all subjects who took at least one dose of study medication.||participants|||Number
839722|NCT01328184|Secondary|Levonorgestrel: Mean Residence Time at Steady State (MRTpo,ss)|Mean residence time of levonorgestrel in the body at steady state after oral administration|Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.|Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.||hours(h)||Geometric Coefficient of Variation|Geometric Mean
841675|NCT01347554|Secondary|Device-oriented Composite Outcome|defined as a composite of all-cause mortality, any MI (includes non-target vessel territory) and repeat revascularization (includes all target and non-target vessel)|Two years|||participants|||Number
839723|NCT01328184|Secondary|Ethinylestradiol: Mean Residence Time at Steady State (MRTpo,ss)|Mean residence time of ethinylestradiol in the body at steady state after oral administration|Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.|Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.||hours(h)||Geometric Coefficient of Variation|Geometric Mean
839724|NCT01328184|Secondary|Levonorgestrel: Terminal Rate Constant at Steady State (λz,ss)|Terminal rate constant of levonorgestrel in plasma at steady state|Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.|Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.||1/h||Geometric Coefficient of Variation|Geometric Mean
839725|NCT01328184|Secondary|Ethinylestradiol: Terminal Rate Constant at Steady State (λz,ss)|Terminal rate constant of ethinylestradiol in plasma at steady state|Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.|Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.||1/h||Geometric Coefficient of Variation|Geometric Mean
839726|NCT01328184|Secondary|Levonorgestrel: Terminal Half-life at Steady State (t1/2,ss)|Terminal half-life of levonorgestrel in plasma at steady state|Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.|Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.||hours(h)||Geometric Coefficient of Variation|Geometric Mean
839727|NCT01328184|Secondary|Ethinylestradiol: Terminal Half-life at Steady State (t1/2,ss)|Terminal half-life of ethinylestradiol in plasma at steady state|Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.|Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.||hours(h)||Geometric Coefficient of Variation|Geometric Mean
839728|NCT01328184|Secondary|Levonorgestrel: Apparent Volume of Distribution During the Terminal Phase at Steady State (Vz/Fss)|Apparent volume of distribution during the terminal phase at steady state after oral administration|Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.|Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.||L||Geometric Coefficient of Variation|Geometric Mean
839729|NCT01328184|Secondary|Ethinylestradiol: Apparent Volume of Distribution During the Terminal Phase at Steady State (Vz/Fss)|Apparent volume of distribution during the terminal phase at steady state after oral administration|Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.|Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.||L||Geometric Coefficient of Variation|Geometric Mean
839730|NCT01328184|Secondary|Levonorgestrel: Apparent Clearance at Steady State (CL/Fss)|Apparent clearance of levonorgestrel in the plasma at steady state after oral administration|Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.|Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.||mL/min||Geometric Coefficient of Variation|Geometric Mean
839731|NCT01328184|Secondary|Ethinylestradiol: Apparent Clearance at Steady State (CL/Fss)|Apparent clearance of ethinylestradiol in the plasma at steady state after oral administration|Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.|Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.||mL/min||Geometric Coefficient of Variation|Geometric Mean
839732|NCT01328184|Secondary|Levonorgestrel: Time From Last Dosing to Maximum Measured Concentration (Tmax,ss)|Time from last dosing to the maximum measured concentration of levonorgestrel in plasma at steady state|Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.|Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.||hours(h)||Full Range|Median
839733|NCT01328184|Secondary|Ethinylestradiol: Time From Last Dosing to Maximum Measured Concentration (Tmax,ss)|Time from last dosing to the maximum measured concentration of ethinylestradiol in plasma at steady state|Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.|Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.||hours(h)||Full Range|Median
839734|NCT01328184|Primary|Levonorgestrel: Maximum Measured Concentration (Cmax,ss)|Maximum measured concentration of levonorgestrel in plasma at steady state over the uniform dosing interval τ.|Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.|Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
839735|NCT01328184|Primary|Ethinylestradiol: Maximum Measured Concentration (Cmax,ss)|Maximum measured concentration of ethinylestradiol in plasma at steady state over the uniform dosing interval τ.|Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.|Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.||pg/mL||Geometric Coefficient of Variation|Geometric Mean
839736|NCT01328184|Primary|Levonorgestrel: Area Under the Curve at Steady State Over the Uniform Dosing Interval τ (AUCτ,ss)|Area under the concentration-time curve of levonorgestrel in plasma at steady state over the uniform dosing interval τ.|Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.|Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
839737|NCT01328184|Primary|Ethinylestradiol: Area Under the Curve at Steady State Over the Uniform Dosing Interval τ (AUCτ,ss)|Area under the concentration-time curve of ethinylestradiol in plasma at steady state over the uniform dosing interval τ.|Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.|Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
839738|NCT01321554|Secondary|Pharmacokinetic (PK) Profile of Lenvatinib: Area Under the Plasma Concentration Curve|AUC was used to determine the total exposure of lenvatinib in blood plasma. From each participant, a total of up to 12 blood samples were collected at the following specified time points: predose, 0.5 to 4 hours postdose, and 6 to 10 hours postdose on Cycle 1/Day 1 and Cycle 1/Day 15; predose and 2 to 12 hours postdose on Cycle 2/Day 1; and predose only on Day 1 of Cycles 3 to 6. The samples were analyzed for the concentration of lenvatinib using validated analytical methods. Population PK model and observed concentration data were used to derive model-predicted lenvatinib PK parameters and lenvatinib exposure (AUC) based on the 24 mg starting dose.|Cycle 1 Day 1 through Cycle 6 Day 1|PK Analysis Set - All the subjects who received at least one dose of study drug and had evaluable PK data||ng*h/mL||Full Range|Median
839739|NCT01321554|Secondary|Overall Survival (OS)|Overall survival measured from the date of randomization until date of death from any cause. Overall survival is adjusted with rank preserving structural failure time.|Date of randomization until date of death from any cause, assessed up to data cutoff date (15 Nov 2013) or up to approximately 2.5 years|Full Analysis Set||months||95% Confidence Interval|Median
839740|NCT01321554|Secondary|Overall Response Rate (ORR)|ORR, defined as the proportion of participants who had best overall response (BOR) of complete response (CR) or partial response (PR) as determined by blinded IIR using RECIST 1.1 for target lesions and assessed by MRI/CT scans (for double blind treatment period i.e. Randomization Phase). CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR = CR + PR.|Date of randomization to the date of disease progression or death (whichever occurred first), assessed up to data cutoff date (15 Nov 2013) or up to approximately 2.5 years|Full Analysis Set||percentage of participants||95% Confidence Interval|Number
839741|NCT01321554|Primary|Progression Free Survival (PFS)|PFS was defined as the time from the date of randomization to the date of first documentation of disease progression or death (whichever occurred first), as determined by blinded independent imaging review (IIR) using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 for the double-blind treatment period (Randomization Phase). Disease progression per RECIST v1.1 was defined as at least a 20% relative increase and 5 mm absolute increase in the sum of diameters of target lesions (taking as reference the smallest sum on study), recorded since the treatment started or the appearance of 1 or more new lesions.|Date of randomization to the date of disease progression or death (whichever occurred first), assessed up to data cutoff date (15 Nov 2013) or up to approximately 2.5 years|Full Analysis Set (Intent-to-Treat Analysis Set) included all randomized subjects.||months||95% Confidence Interval|Median
839742|NCT01321697|Primary|Successful Identification of Vulvar Sentinel Lymph Nodes Via Gamma Probe.||at time of surgery|Data were not collected/analyzed due to study termination.|||||
839743|NCT01321710|Primary|Change in Infant Sleep Quantity (Objective)|Change in infant sleep quantity is defined as the difference between the number of hours slept in the 24 hours prior to immunization and the the number of hours slept after immunization (positive numbers indicate more sleep following immunization). Infant sleep was measured by ankle actigraphy.|24 hours before and 24 hours after immunizations at approximately 2 months of age|ITT analysis. Infants who were not immunized or did not have valid outcome data were excluded from the analysis.||minutes||Standard Deviation|Mean
839744|NCT01321710|Secondary|Maternal Well-being|Maternal well-being was measured by the total score on the Center for Epidemiologic Studies - Depression Scale (CES-D). The CES-D measures depressive symptoms in the past week. CES-D scores can range 0 to 60, with higher scores indicating more symptoms of depression.|1 month postpartum (approximately)|ITT analysis.||Scores on a scale||Standard Deviation|Mean
839745|NCT01321710|Secondary|Maternal Sleep Disturbance (Subjective)|Maternal sleep disturbance is measured by the total score on the General Sleep Disturbance Scale (GSDS). The GSDS is a self-report questionnaire that measures perceived sleep disturbance in the past week. GSDS scores range from 0 to 147, with higher scores indicating more sleep disturbance.|1 month postpartum (approximately)|ITT analysis.||Scores on a scale||Standard Deviation|Mean
839746|NCT01321710|Primary|Maternal Sleep Quality (Objective)|Maternal sleep quality is defined as sleep efficiency (percent sleep per time in bed averaged across 3 nights) as measured by wrist actigraphy.|1 month postpartum (approximately)|ITT analysis. Because this was a repeated measures analysis at 1 and 3 months postpartum, subjects missing outcome data at either point were excluded from the analysis.||percentage of sleep per time in bed||Standard Deviation|Mean
841676|NCT01347554|Primary|Device-oriented Composite Outcome|defined as a composite of cardiac death, Myocardial infarction not clearly attributable to a nontarget vessel and target lesion revascularization|Two year|||participants|||Number
839750|NCT01321723|Secondary|% Change From Baseline in Bone Resorption Marker (CTx-1) at Week 24|Serum collagen type I (CTx-1) fragments generated during osteoclastic bone turnover are biomarkers for bone resorption. β-CrossLaps electrochemiluminescent sandwich immunoassay was used.|24 weeks from baseline|mITT Population: all subjects who received at least one dose of treatment and at least one post-baseline BMD value. Missing data imputation for patients who completed Week 12 but not the full 24-week period, data was imputed using the LOCF. No data imputation was performed for Week 24, if the Week 12 data was missing.||percentage of change||Standard Deviation|Mean
839751|NCT01321723|Post-Hoc|Number of Participants With AEs as a Measure of Safety and Tolerability||24 weeks|Overall Summary of Adverse Events - Each subject with an event is counted only once although they may have several events.||participants|||Number
839752|NCT01321723|Primary|% Change From Baseline BMD in L1-L4 Axial Lumbar Spine at Week 24||24 weeks from baseline|mITT Population: all subjects who received at least one dose of treatment and at least one post-baseline BMD value. Missing data imputation for patients who completed Week 12 but not the full 24-week period, data was imputed using the LOCF. No data imputation was performed for Week 24, if the Week 12 data was missing.||percentage of change||Standard Deviation|Mean
839753|NCT01321749|Secondary|Brain Perfusion Improvement Are Evaluated With SPECT and TCD|Brain perfusion status were evalvated by SPECT SPECT scanning was performed using a dual headed rotating gamma camera at 30 minutes after intravenous 99mTc-ECD (25mCi) bolus injection and at 40 minutes after 18F -FDG bolus injection.|300-day after treatment||||||
839754|NCT01321749|Secondary|The Time Point Until the First Stroke Recurrence,|These patients underwent MRI/DWI at the time of first recurrence; patients without symptoms recurrence underwent follow-up MRI/DWI at 300 days.|At the 300-day after the initial treatment||||||
839755|NCT01321749|Primary|Number of Patients Who Got New Brain Lesions|We compared the number of patients who got new lesions in the Diffusion-weighted magnetic resonance imaging (DWI-MRI)|300 days after treatment|||participants|||Number
839756|NCT01321749|Primary|Plasma Biomarkers of Coagulation and Fibrinolysis|blood samples were collected one hour after every times of BLIPC procedure ended, and assayed with the immuno-turbidimetry assay on the coagulation laboratory autoanalyzer|the time points of baseline and 1, 15 and 30 days after BLIPC treatment||||||
839757|NCT01321749|Primary|Blood Pressure and Heart Rates;||at the time points of baseline and 1, 15 and 30 days after BLIPC treatment||||||
839758|NCT01322009|Secondary|Antioxidant Reserve|Antioxidant reserves in CSF and serum will be calculated in both treatment arms and compared.|Within 5 days of injury|||reactive oxygen species scavenged||Standard Error|Mean
839759|NCT01322009|Primary|Number of Participants Who Experienced Adverse Events|"The number of patients experiencing one or more of the following adverse events:
Acute renal failure Anaphylaxis Acute respiratory distress syndrome Intracranial infection/abscess Arrhythmia, atrial Arrhythmia, ventricular Bradycardia Cardiac arrest Catheter positive culture Cerebrospinal fluid leak Decubitis Deep vein thrombosis Diabetes Insipidus Emesis Extraaxial hematoma Gastrointestinal bleed Gastritis Hematuria Hemorrhage, other Hemoperitonium Hemothorax Hepatitis Hydrocephalus Hypotension Hypoxemia Infection, other Intraparenchymal hemorrhage Intraventricular hemorrhage Meningitis/ventriculitis Multiorgan dysfunction syndrome Myocardial ischemia Pancreatitis Pericarditis Peritonitis Pneumothorax Pulmonary edema Pulmonary embolism Respiratory arrest Seizures Sepsis Syndrome of inappropriate antidiuretic hormone Transtentorial herniation Withdrawal of Life Support Other SAE causing re-hospitalization Other SAE"|14 days after drug administration|||participants|||Number
839760|NCT01322022|Primary|Actigraphy - Sleep Latency|Measure of sleep latency defined by the time from lights off to sleep onset.|Baseline, Week 4, Week 8|||minutes||Standard Deviation|Mean
839761|NCT01322022|Primary|Actigraphy - Sleep Efficiency|Measure of sleep efficiency defined as the percentage of time sleeping while in bed with lights off|Baseline, Week 4, Week 8|||Percentage of Time Sleeping||Standard Deviation|Mean
839762|NCT01322022|Secondary|Actigraphy - Total Sleep Time|Measure of total time spent asleep using Motionlogger model actigraph by Ambulatory Monitoring, Inc. (www.ambulatory-monitoring.com) and algorithms in associated software.|Baseline, Week 4, Week 8|||minutes||Standard Deviation|Mean
839763|NCT01322022|Primary|Modified Simond & Parraga Sleep Questionnaire (MSPSQ) - Composite Sleep Index|The MSPSQ used by Wiggs and colleagues (Wiggs & Stores, 1996 ; Wiggs & Stores, 1999 : Wiggs & Stores, 2004) was used to assess the child's sleep quality. It was completed by the primary caregiver for both groups at baseline and at weeks 4 and 8. Using Wiggs & Stores earlier-described conventions for determining the Composite Sleep Index (CSI) score, the CSI was calculated by assigning a score to the frequency of the targeted sleep problems: bedtime resistance, night awakening, early awakening, and sleeping in places other than bed. In addition, scores were assigned for the duration of sleep latency and night awakenings. The total CSI score ranged from 0 to 12, with higher scores indicating more severe bedtime and sleep patterns.|Baseline, Week 4, and Week 8|||units on a scale||Standard Deviation|Mean
839764|NCT01322048|Secondary|Plasma Norepinephrine Levels||Post-treatment (t=Day 8)|Of those surviving treatment period||pg/mL||Inter-Quartile Range|Median
839765|NCT01322048|Primary|Ventilator-free Days||Baseline to day 28|||days||Inter-Quartile Range|Median
839766|NCT01322347|Primary|Change From Baseline Hemoglobin at End-of-Treatment: Mean Baseline and End-of-Treatment Hemoglobin|Mean change from baseline Hgb (the average of the three most recent Hgb values preceding randomization) assessments during the last one-sixth of the treatment period for patients who prematurely withdraw from study treatment, but will include a minimum of at least the last two Hgb values. Values expressed are mean baseline and end-of-treatment Hgb, along with the mean difference (standard deviation).|Hgb measured weekly; up to 48 weeks from date of randomization|modified intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin value measured.||grams per liter||Standard Deviation|Mean
839767|NCT01322347|Secondary|Variability of Hemoglobin Concentration: Residual Standard Deviation|The mean residual standard deviation of the hemoglobin concentration changes, as measured weekly from baseline until the end of participation in Stage 2.|up to 48 weeks from date of randomization|modified intent-to-treat: all randomized subjects who received at least one dose of study medication and had at least one post dose hemoglobin measured.||grams per liter||Standard Deviation|Mean
839972|NCT01330355|Primary|Clinical Resolution|Clinical resolution defined as the absence of both conjunctival discharge and conjunctival hyperemia.|Visit 5 (Day 8+1)|The analysis population only includes those for whom the outcome was measured within the specified time frame.||participants|||Number
839768|NCT01322347|Secondary|Variability of Hemoglobin Concentration: Temporal Trend|The mean temporal trend of hemoglobin concentration value changes, as measured weekly from baseline until the end of participation in Stage 2.|up to 48 weeks from date of randomization|modified intent-to-treat: all randomized subjects who received at least one dose of study medication and had at least one post dose hemoglobin measured.||grams per liter per week||Standard Deviation|Mean
839769|NCT01322347|Secondary|Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin Saturation (TSAT)|The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin Saturation (TSAT)|Up to 48 weeks from date of randomization|modified intent-to-treat: all randomized subjects who received at least one dose of study medication and had at least one post-dose hemoglobin measured.||percentage||Standard Deviation|Mean
839770|NCT01322347|Secondary|Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin|The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin|Up to 48 weeks from date of randomization|modified intent-to-treat: all randomized subjects who received at least one dose of study medication and had at least one post-dose hemoglobin measured.||grams per liter||Standard Deviation|Mean
839771|NCT01322347|Secondary|Change From Baseline to End-of-Treatment (EoT) in Ferritin|The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Ferritin|Up to 48 weeks from date of randomization|modified intent-to-treat: all randomized subjects who received at least one dose of study medication and had at least one post-dose hemoglobin measured.||micrograms per liter||Standard Deviation|Mean
839772|NCT01322347|Secondary|Change From Baseline to End-of-Treatment (EoT) in Reticulocyte Hemoglobin (CHr)|The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Reticulocyte Hemoglobin (CHr)|Up to 48 weeks from date of randomization|modified intent-to-treat: all randomized subjects who received at least one dose of study medication and had at least one post-dose hemoglobin measured.||picograms||Standard Deviation|Mean
839773|NCT01322347|Secondary|Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Unsaturated Iron-Binding Capacity (UIBC), Pre-Dialysis Serum Iron, and Pre-Dialysis Total Iron-Binding Capacity (TIBC)|The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Pre-Dialysis Unsaturated Iron-Binding Capacity (UIBC), Pre-Dialysis Serum Iron, and Pre-Dialysis Total Iron-Binding Capacity (TIBC) will be quantified.|Up to 48 weeks from date of randomization|modified intent-to-treat: all randomized subjects who received at least one dose of study medication and had at least one post-dose hemoglobin measured.||micromoles per liter||Standard Deviation|Mean
839774|NCT01322347|Secondary|Percentage of Change From Baseline to End-of-Treatment for: Reticulocyte Hemoglobin Content (CHr), Ferritin, and the Pre-Dialysis Serum Iron Panel|A comparison of the lab values at the end-of-treatment (EoT) to baseline was performed, and the percentage of change from baseline was calculated for the following lab parameters: reticulocyte hemoglobin content (CHr), Ferritin, pre-dialysis unbound iron-binding capacity (UIBC), pre-dialysis serum iron, pre-dialysis transferrin, pre-dialysis total iron-binding capacity TIBC), and transferrin saturation (TSAT).|up to 48 weeks from date of randomization|modified intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin measured.||percentage of change from baseline||Standard Deviation|Mean
839775|NCT01322347|Secondary|Red Blood Cell or Whole Blood Transfusion: Number of Units Transfused|The total number of units of red blood cells or whole blood that were received by patients while in the randomized treatment stage (Stage 2). This number is the total number of units received across all randomized patients in each treatment group (it is not the average number of units received per patient). Patients remained in Stage 2 until they met protocol-defined criteria for Stage 2 completion or until they had participated in Stage 2 for 48 weeks (whichever came sooner). If a patient was transfused, they were withdrawn from Stage 2.|Up to 48 weeks from date of randomization|intent-to-treat: all randomized subjects||units of red blood cells or whole blood|||Number
839776|NCT01322347|Secondary|Red Blood Cell or Whole Blood Transfusion: Number of Patients Who Received a Transfusion|The number of patients requiring red blood cell or whole blood transfusion while in the randomized treatment stage (Stage 2). Patients remained in Stage 2 until they met protocol-defined criteria for Stage 2 completion or until they had participated in Stage 2 for 48 weeks (whichever came sooner). If a patient was transfused, they were withdrawn from Stage 2.|Up to 48 weeks from date of randomization|intent-to-treat: all randomized subjects||participants|||Number
839777|NCT01322347|Secondary|Mean Change in Unsaturated Iron-Binding Capacity (UIBC) From Pre-Dialysis to Post-Dialysis|The mean difference between the pre-dialysis and post-dialysis unsaturated iron binding capacity (UIBC) was calculated, using all post-baseline values obtained during Stage 2. Subjects could participate in Stage 2 for up to 48 weeks, provided that they did not complete Stage 2 early due to a protocol-mandated change in anemia management or withdraw from the study entirely for other reasons.|Up to 48 weeks from date of randomization|modified intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin measured.||micromole per liter||Standard Deviation|Mean
839778|NCT01322347|Secondary|Mean Change in Transferrin Saturation From Pre-Dialysis to Post-Dialysis|The mean difference between the pre-dialysis and post-dialysis TSAT (transferrin) was calculated, using all post-baseline values obtained during Stage 2. Subjects could participate in Stage 2 for up to 48 weeks, provided that they did not complete Stage 2 early due to a protocol-mandated change in anemia management or withdraw from the study entirely for other reasons.|Up to 48 weeks from date of randomization|modified intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin measured.||percent||Standard Deviation|Mean
839779|NCT01322347|Secondary|Mean Change in Serum Iron From Pre-Dialysis to Post-Dialysis|The mean difference between the pre-dialysis and post-dialysis serum iron was calculated, using all post-baseline values obtained during Stage 2. Subjects could participate in Stage 2 for up to 48 weeks, provided that they did not complete Stage 2 early due to a protocol-mandated change in anemia management or withdraw from the study entirely for other reasons.|Up to 48 weeks from date of randomization|modified intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dialysis hemoglobin measured.||micromoles per liter||Standard Deviation|Mean
839973|NCT01330381|Secondary|Convenience of Treatment for Final On Treatment Assessment in Open-Label Treatment Period||Over the 16 week open label treatment period|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome.||percentage of subjects|||Number
839780|NCT01322347|Primary|Change From Baseline Hemoglobin at End-of-Treatment: Least-Squares Mean|Mean change from baseline Hgb (the average of the three most recent Hgb values preceding randomization) assessments during the last one-sixth of the treatment period for patients who prematurely withdraw from study treatment, but will include a minimum of at least the last two Hgb values. Value is expressed as least-squares mean, along with standard error.|Hgb measured weekly; up to 48 weeks from date of randomization|modified intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin value measured.||grams per liter||Standard Error|Least Squares Mean
839781|NCT01322360|Secondary|Number of Subjects Who Experienced Adverse Events of Moderate to Severe Intensity / Grade|Subjects who experienced any AEs of special interest, which included sedation, respiratory depression, nausea, vomiting, and pruritus of moderate to severe intensity/grade|Up to 21 days|||participants|||Number
839782|NCT01322360|Primary|Number of Subjects Who Experienced Adverse Events That Led to Study Discontinuation|"The primary safety endpoints were the percentage of subjects who experienced any AEs that led to study discontinuation, percentage of subjects with SAEs and those with a sedation score of 4. Secondary safety endpoints included the percentage of subjects who experienced any AEs of special interest, which included sedation, respiratory depression, nausea, vomiting, and pruritus of moderate to severe intensity/grade.
Additional secondary endpoints were the incidence, type, relationship to study drug, and severity of AEs, and the percentage of subjects with clinically significant decreases in SpO2 and respiratory rate, as assessed by the investigator."|Up to 21 days|75 subjects were screened and 50 subjects took at least one dose of oral morphine sulfate.||participants|||Number
839783|NCT01322386|Primary|Determine the Benefit of Oral Vancomycin Therapy for Primary Sclerosing Cholangitis and Biliary Atresia|Determine the benefit of oral vancomycin therapy for Primary Sclerosing Cholangitis and Biliary Atresia through improvement of Liver function tests (LFTs) within 3 months of initiating therapy. In addition for PSC, we looked at 25% reduction of abnormal ALT & GGT, reduction in biliary strictures and beading, and reduction of inflammation in liver biopsies and colon biopsies.|Within 3 months of therapy|Ten BA participants had surgery (Kasai portoenterostomyprocedure) at 1 week before starting the Vancomycin so we could not determine if they benefited from the therapy. On oral vancomycin, 9 PSC patients had improvement of LFTs, 8 had improvement of liver biopsies and/or MRI, and colon biopsies,and 1 pt. refused to have these additional studies.||participants|||Number
839784|NCT01328366|Secondary|International Index of Erectile Function Score|The International Index of Erectile Function (IIEF) was a participant-reported questionnaire used to measure a male’s erection function. Scores range from 5-75, higher scores indicated better erection quality. Data are reported as the mean IIEF score ± standard deviation.|Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation|Male participants who completed the IIEF questionnaire at Baseline, 4 Week, 16 Week, or their 6 Month assessment.||units on a scale||Standard Deviation|Mean
839785|NCT01328366|Secondary|Mean Change in Female Sexual Function Index (FSFI) Score From Baseline|The Female Sexual Function Index was a participant-reported questionnaire used to measure a female’s sexual function. Scores range from 2-36, higher scores indicated better sexual function. Data are reported as the mean change in FSFI score ± standard deviation.|4 week, 16 weeks, and 6 months following adalimumab initiation|Female participants who completed the FSFI questionnaire at baseline and at the 4 Week, 16 Week, or 6 Month assessment. Participants who did not complete a Baseline and 4 Week, 16 Week, or 6 Month assessment were not included in the analysis.||units on a scale||95% Confidence Interval|Mean
839786|NCT01328366|Secondary|Female Sexual Function Index (FSFI) Score|The Female Sexual Function Index (FSFI) was a participant-reported questionnaire used to measure a female’s sexual function. Scores range from 2-36, higher scores indicated better sexual function. Data are reported as the mean FSFI score ± standard deviation.|Baseline; 16 weeks, and 6 months following adalimumab initiation|Female participants who completed the FSFI questionnaire at Baseline, 4 Week, 16 Week, or their 6 Month assessment.||units on a scale||Standard Deviation|Mean
839787|NCT01328366|Secondary|Change in 12-item Short Form Survey (SF-12) Score From Baseline|The 12-item Short Form Survey (SF-12) was a participant-reported questionnaire use to measure the functional health and well-being of a participant to include both physical and mental health domains. Scores range from 0-100 for each domain, higher scores indicated better physical or mental health. Data are reported as the mean change SF-12 score physical or mental ± standard deviation.|4 weeks, 16 weeks, and 6 months following adalimumab initiation|Participants who completed the SF-12 questionnaire at baseline and at the 4 Week, 16 Week, or 6 Month assessment. Participants who did not complete a Baseline and 4 Week, 16 Week, or 6 Month assessment were not included in the analysis.||units on a scale||95% Confidence Interval|Mean
839788|NCT01328366|Secondary|12-item Short Form Survey (SF-12) Score|The 12-item Short Form Survey (SF-12) was a participant-reported questionnaire use to measure the functional health and well-being of a participant to include both physical and mental health domains. Scores range from 0-100 for each domain, higher scores indicated better physical or mental health. Data are reported as the mean SF-12 score physical or mental ± standard deviation.|Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation|Participants who completed the SF-12 questionnaire at Baseline, 4 Week, 16 Week, or their 6 Month assessment.||units on a scale||Standard Deviation|Mean
839789|NCT01328366|Secondary|Mean Change in Cutaneous Body Image (CBI) Scale Scores From Baseline|The Cutaneous Body Image (CBI) Scale was a participant-reported questionnaire used to measure a participant’s satisfaction with their hair, nails, and skin. Scores range from 0-9, higher scores indicated a higher level of satisfaction. Data are reported as the mean change in CBI score ± standard deviation.|4 weeks, 16 weeks, and 6 months following adalimumab initiation|Participants who completed the CBI questionnaire at baseline and at the 4 Week, 16 Week, or 6 Month assessment. Participants who did not complete a Baseline and 4 Week, 16 Week, or 6 Month assessment were not included in the analysis.||units on a scale||95% Confidence Interval|Mean
839790|NCT01328366|Secondary|Cutaneous Body Image Scale (CBI) Scores|The Cutaneous Body Image (CBI) Scale was a participant-reported questionnaire used to measure a participant’s satisfaction with their hair, nails, and skin. Scores range from 0-9, higher scores indicated a higher level of satisfaction. Data are reported as the mean CBI score ± standard deviation.|Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation|Participants who completed the CBI questionnaire at Baseline, 4 Week, 16 Week, or their 6 Month assessment.||units on a scale||Standard Deviation|Mean
841677|NCT01347580|Secondary|Minor and Major Bleeds After 48 Hours|non CABG related bleeds (PLATO definition)|after 48 hours post first dose|safety||patients|||Number
839791|NCT01328366|Secondary|Mean Change in Hospital Anxiety and Depression Scale (HADS) Scores From Baseline|The Hospital Anxiety and Depression Scale (HADS) was a patient-reported questionnaire used to assess the level of anxiety and depression in the setting of a hospital medical outpatient clinic. The anxiety and depression subscales each have a range from 0-21, higher scores indicated higher levels of anxiety and depression, respectively. Data are reported as the mean change in anxiety or depression score ± standard deviation.|4 weeks, 16 weeks, and 6 months following adalimumab initiation|Participants who completed the HADS questionnaire at baseline and at the 4 Week, 16 Week, or 6 Month assessment. Participants who did not complete a Baseline and 4 Week, 16 Week, or 6 Month assessment were not included in the analysis. HADS-A refers to the anxiety, while HADS-D refers to the depression portion of the survey.||units on a scale||95% Confidence Interval|Mean
839792|NCT01328366|Secondary|Hospital Anxiety and Depression Scale (HADS) Scores|The Hospital Anxiety and Depression Scale (HADS) was a patient-reported questionnaire used to assess the level of anxiety and depression in the setting of a hospital medical outpatient clinic. The anxiety and depression subscales each have a range from 0-21, higher scores indicated higher levels of anxiety and depression, respectively. Data are reported as the mean anxiety or depression score ± standard deviation.|Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation|Participants who completed the HADS questionnaire at Baseline, 4 Week, 16 Week, or their 6 Month assessment. HADS-A refers to the anxiety, while HADS-D refers to the depression portion of the survey.||units on a scale||Standard Deviation|Mean
839793|NCT01328366|Secondary|Mean Change in Psoriasis Area and Severity Index (PASI) Scores From Baseline|The Psoriasis Area and Severity Index (PASI) questionnaire was used by the clinical staff to measure the severity of a participant’s psoriasis, taking into account the area of psoriasis legions on the body and the characteristics of these legions (redness, thickness, scaliness). Scores range from 0-72, a higher score indicating more severe psoriasis. Data are reported as the mean change in PASI score ± standard deviation.|4 weeks, 16 weeks, and 6 months following adalimumab initiation|Participants who completed the PASI questionnaire at Baseline, 4 Weeks, 16 Weeks, or their 6 Month assessment. Participants who did not complete a Baseline and 4 Week, 16 Week, or 6 Month assessment were not included in the analysis.||units on a scale||95% Confidence Interval|Mean
839794|NCT01328366|Secondary|Psoriasis Area and Severity Index (PASI) Scores|The Psoriasis Area and Severity Index (PASI) questionnaire was used by the clinical staff to measure the severity of a participant’s psoriasis, taking into account the area of psoriasis legions on the body and the characteristics of these legions (redness, thickness, scaliness). Scores ranged from 0-72, a higher score indicated more severe psoriasis. Data are reported as the mean PASI score ± standard deviation.|Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation|Participants who completed the PASI questionnaire at Baseline, 4 Weeks, 16 Weeks, or their 6 Month assessment.||units on a scale||Standard Deviation|Mean
839795|NCT01328366|Secondary|Mean Change in Self-assessed Psoriasis Area and Severity Index (SAPASI) Scores From Baseline|The Self-assessed Psoriasis Area and Severity Index (SAPASI) questionnaire was used to objectively measure the severity of a participant’s psoriasis, taking into account the area of psoriasis legions on the body and the characteristics of these legions (redness, thickness, scaliness). Scores ranged from 0-72, a higher score indicated more severe psoriasis. Data are reported as the mean change in SAPASI score ± standard deviation.|4 weeks, 16 weeks, and 6 months after adalimumab initiation|Participants who completed the SAPASI questionnaire at Baseline, 4 Weeks, 16 Weeks, or their 6 Month assessment. Participants who did not complete a Baseline and 4 Week, 16 Week, or 6 Month assessment were not included in the analysis.||units on a scale||95% Confidence Interval|Mean
839796|NCT01328366|Secondary|Self-assessed Psoriasis Area and Severity Index (SAPASI) Scores|The Self-assessed Psoriasis Area and Severity Index (SAPASI) questionnaire was used to objectively measure the severity of a participant’s psoriasis, taking into account the area of psoriasis legions on the body and the characteristics of these legions (redness, thickness, scaliness). Scores ranged from 0-72, a higher score indicated more severe psoriasis. Data are reported as the mean SAPASI score ± standard deviation.|Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation|Participants who completed the SAPASI questionnaire at Baseline, 4 Weeks, 16 Weeks, or their 6 Month assessment.||units on a scale||Standard Deviation|Mean
839797|NCT01328366|Primary|Mean Change in Dermatology Life Quality Index (DLQI) Scores From Baseline|The Dermatology Life Quality Index (DLQI) was a participant-reported questionnaire used to measure the health-related quality of life (QOL) of adults suffering from a skin disease. Scores ranged from 0-30, a higher score indicated a greater impact on a participant’s QOL. “Responders” to adalimumab had a ≥5 point reduction in DLQI scores or DLQI score of 0. Data are reported as the mean DLQI score ± standard deviation.|4 weeks, 16 weeks, and 6 months following adalimumab initiation|Participants who completed the DLQI questionnaire at baseline and at the 4 Week, 16 Week, or 6 Month assessment. Participants who did not complete a Baseline and 4 Week, 16 Week, or 6 Month assessment were not included in the analysis.||units on a scale||95% Confidence Interval|Mean
839798|NCT01328366|Primary|Dermatology Life Quality Index (DLQI) Scores|The Dermatology Life Quality Index (DLQI) was a participant-reported questionnaire used to measure the health-related quality of life (QOL) of adults suffering from a skin disease. Scores ranged from 0-30, a higher score indicating a greater impact on a participant’s QOL. Data are reported as the mean DLQI score ± standard deviation.|Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation|Participants who completed the DLQI questionnaire at Baseline, 4 Week, 16 Week, or their 6 Month assessment.||units on a scale||Standard Deviation|Mean
839799|NCT01328379|Secondary|Change From Baseline in EQ-5D Visual Analogue Self-rating (VAS) Score at Visit 3.|The EQ-5D is a brief questionnaire that asks patients to rate general state of health. The VAS score rates the general state of health of a patient with 100 for the best imaginable health state and 0 for the worst imaginable health state.|Baseline Visit 1 (double-blind study day 1) and Visit 3 (end of double-blind week 4)|Full Analysis Population. The number of participants analyzed corresponds with number of subjects who completed the questionnaire in each treatment group.||units on a scale||Standard Error|Mean
839811|NCT01328431|Secondary|Health Care Service Utilization|A version of the Treatment Services Review (TSR) will be used to assess health care utilization during follow-ups. The TSR is a self-report instrument that asks about hospitalizations, emergency room visits, and outpatient medical and psychiatric care. The version used in this study also asks about how often the subject called the CT Smoker's Quitline, use of NRT or other medications for smoking cessation, and participation in other smoking cessation treatments.|12 months post enrollment||||||
839800|NCT01328379|Secondary|Change From Baseline in EuroQol Group 5 Dimensions (EQ-5D) Scores at Visit 3.|"Patients completed a brief, generic health status questionnaire: The five specific dimensional scores value patients’ health related to mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each question has 3 distinguishable choices that can be analyzed using a 3-point scale (i.e. 1 = no problem, 2=some problems and 3= extreme problems).
A response of 1 indicates that the patient has no problem with the dimension tested and a response of 3 indicates that the patient has extreme problems with the dimension tested. For each visit, the average score of 5 dimensions was calculated by averaging the scores of 5 dimensions. EQ-5D final score ranges from 1-3."|Baseline Visit 1 (double-blind study day 1) and Visit 3 (end of double-blind week 4)|Full Analysis Population||units on a scale||Standard Error|Mean
839801|NCT01328379|Secondary|Change From Baseline in Six-Minute Walk Distance at Visit 2|The Six-Minute Walk, a test of endurance, measures the distance that a patient can walk in a period of 6 minutes. Six-minute walk distance will be reported in feet.|Visit 1 (Baseline) and Visit 2 (start of third week double-blind treatment period )|Full Analysis Population||Feet||Standard Error|Mean
839802|NCT01328379|Secondary|Change From Baseline in MSWS-12 at Visit 2|"The MSWS-12 is a multi-item rating scale that asks patients to rate limitations of their mobility due to MS during the preceding two weeks on a 5-point scale (from 1= not at all to 5=extremely). The scale assesses a range of activities of daily life that rely on walking, such as climbing stairs, moving around the home and walking distances outdoors. The MSWS-12 also addresses the quality of walking, with questions on the smoothness, speed, distance, effort, and mental concentration involved in walking, as well as the need for assistive devices.
For each visit, the MSWS-12 score was calculated by summing the 12 components and transforming into a scale with a range of 0 to 100.
MSWS-12 Score = 100 * [(Sum of Items 1-12) – 12]/48"|Visit 1 (Baseline) and Visit 2 (start of third week double-blind treatment period )|Full Analysis Population||scores on a scale||Standard Error|Mean
839803|NCT01328379|Secondary|Change From Baseline in 12-item MS Walking Scale (MSWS-12) at Visit 3|"The MSWS-12 is a multi-item rating scale that asks patients to rate limitations of their mobility due to MS during the preceding two weeks on a 5-point scale (from 1= not at all to 5=extremely). The scale assesses a range of activities of daily life that rely on walking, such as climbing stairs, moving around the home and walking distances outdoors. The MSWS-12 also addresses the quality of walking, with questions on the smoothness, speed, distance, effort, and mental concentration involved in walking, as well as the need for assistive devices.
For each visit, the MSWS-12 score was calculated by summing the 12 components and transforming into a scale with a range of 0 to 100.
MSWS-12 Score = 100 * [(Sum of Items 1-12) – 12]/48"|Baseline Visit 1 (double-blind study day 1) and Visit 3 (end of double-blind week 4)|Full Analysis Population||scores on a scale||Standard Error|Mean
839804|NCT01328379|Secondary|Change From Baseline in Walking Speed Near Minimum Plasma Concentration at Steady State (CminSS) of Placebo, Dalfampridine-ER (5mg and 10mg), Using the Timed 25 Foot Walk (T25FW).|"The T25FW test is a quantitative measure of ambulatory function that is widely used by MS specialists to assess the global impact of the disease and its progression on the patient’s physical disability.
A patient will stand with the toes of his/her shoes on the starting line (identified by a taped mark on the floor) and timing will begin when any part of the patient’s foot crosses the tape. Timing will end when any part of the patient’s foot crosses the finish line (identified by a taped mark on the floor). Time will be recorded in seconds and rounded to the nearest tenth of a second using a stopwatch provided for this study."|Baseline Visit 1 (double-blind study day 1) and approximately 12 hours post dose at Visit 3 (end of double-blind week 4)|Full Analysis Population||feet per second||Standard Error|Mean
839805|NCT01328379|Primary|Change From Baseline in Walking Speed Near Maximum Plasma Concentration at Steady State (CmaxSS) of Placebo and Dalfampridine-ER (5mg and 10mg), Using the Timed 25 Foot Walk (T25FW).|"The T25FW test is a quantitative measure of ambulatory function that is widely used by MS specialists to assess the global impact of the disease and its progression on the patient’s physical disability.
A patient will stand with the toes of his/her shoes on the starting line (identified by a taped mark on the floor) and timing will begin when any part of the patient’s foot crosses the tape. Timing will end when any part of the patient’s foot crosses the finish line (identified by a taped mark on the floor). Time will be recorded in seconds and rounded to the nearest tenth of a second using a stopwatch provided for this study."|Baseline Visit 1 (double-blind study day 1) and approximately 3-4 hours post dose at Visit 3 (end of double-blind week 4)|Full Analysis Population (FAP): All randomized patients who took at least one dose of double-blind investigational medication and who have a baseline Timed 25 Foot Walk (T25FW) assessment and at least one post-baseline T25FW assessment.||feet per second||Standard Error|Mean
839806|NCT01328405|Secondary|Airway Pathology|The patient will be called 24 hours later by the data collector who will administer a standard oral questionnaire to the patient to determine if a sore throat is present.|Postoperative Day Two|||participants|||Number
839807|NCT01328405|Secondary|Airway Pathology|In the recovery area, once the patient is fully awake, as judged by the recovery staff, an observer will administer a standard oral questionnaire to the patient to determine if a sore throat is present.|Postoperative (day 1) in recovery room|||participants|||Number
839808|NCT01328405|Secondary|Glottic View|Once the LMA has been placed and secured and the patient is stable from an anesthetic point of view, a flexible fiberoptic camera will be place into the airway tube of the LMA and the view of the patient's vocal cords in relation to the cuff of the LMA will be assessed.|Intraoperative (day 1)|||participants with grade 1 glottic view|||Number
839809|NCT01328405|Secondary|Grossly Visible Blood or Bile on LMA|At the conclusion of the case, when the patient is breathing on their own and is awake enough, as judged by the anesthesia provider, the LMA will be removed, as would be otherwise done as standard of care. The study LMA will be examined by a data collector for the presence of grossly visible blood or bile, and its presence or absence will be recorded.|Upon LMA removal|||participants|||Number
839810|NCT01328405|Primary|Airway Seal Pressure|The airway seal pressure will then be assessed by closing the APL valve on the anesthesia machine with a fresh gas flow of 5 liters/minute until an audible leak is observed.|Intraoperative (day 1)|||cmH2O||Standard Deviation|Mean
839833|NCT01328496|Primary|Event Free Survival (EFS) for Research Participants|Estimate EFS for research participants at one-year post transplant by using single unit umbilical cord blood. The event is defined as relapse, graft failure, death due to any cause. The number of participants who did not experience any of those events (relapse, graft failure, death due to any cause) at year 1 post-transplant was given.|1 year post-transplant|||Participants|||Count of Participants
839812|NCT01328431|Secondary|Health Care Service Utilization|A version of the Treatment Services Review (TSR) will be used to assess health care utilization during follow-ups. The TSR is a self-report instrument that asks about hospitalizations, emergency room visits, and outpatient medical and psychiatric care. The version used in this study also asks about how often the subject called the CT Smoker's Quitline, use of NRT or other medications for smoking cessation, and participation in other smoking cessation treatments.|3 months post enrollment||||||
839813|NCT01328431|Secondary|Self-reported Tobacco Reduction or Abstinence|self-report questionnaires are completed over the phone to assess reduction in cigarette use or abstinence from cigarette use.|12 months post enrollment||||||
839814|NCT01328431|Secondary|Health Care Service Utilization|A version of the Treatment Services Review (TSR) will be used to assess health care utilization during follow-ups. The TSR is a self-report instrument that asks about hospitalizations, emergency room visits, and outpatient medical and psychiatric care. The version used in this study also asks about how often the subject called the CT Smoker's Quitline, use of NRT or other medications for smoking cessation, and participation in other smoking cessation treatments.|1 month post enrollment||||||
839815|NCT01328431|Secondary|Self-reported Tobacco Reduction or Abstinence|self-report questionnaires are completed over the phone to assess reduction in cigarette use or abstinence from cigarette use.|1 month post enrollment||||||
839816|NCT01328431|Primary|Self-report of Tobacco Abstinence or Reduction|Questionnaires to assess self reported tobacco abstinence|3 months|This is the # of participants in each group.||participants|||Number
839817|NCT01328431|Primary|Biochemical Verification of Tobacco Abstinence|Biochemical verification means a breathalyzer reading for carbon monoxide.|3 months after enrollment|This is the # of participants in each group.||participants|||Number
839834|NCT01328548|Other Pre-specified|Assessment of Immune Parameters Compatible With Inflammaging: CD4 Cell Frequency|Characterization of T-cell populations will be conducted on whole blood using multi-parametric flow cytometry prior to immunization to characterize the immunological function of circulating T-cells in the nursing home vaccine group.|Baseline|Predictor variables were assessed only among the frail elderly, the community control group served as a control for immunogenicity only.||% of peripheral blood mononuclear cell||Standard Deviation|Mean
839835|NCT01328548|Other Pre-specified|Testing 150 Candidate Immune Response Genes for SNP Analysis|These will include Tolllike receptors, cytokines, chemokines, chemokine receptors, interferons and interferon receptors. Tolllike receptors: TLR1TLR9 Cytokines: ILI1A, ILI1B, IL1RN, IL4, IL5, IL12B, IL13, CSF2 Chemokines: CCL1CCL3, CCL3L1, CCL4CCL8, CCL11, CCL13, CCL15CCL28, CXCL1CXCL14, CXCL16, CX3CL1 Chemokine receptors: CCR1CCR10, CXCR1CXCR6, CX3CR1, XCR1XCR2 Interferons: IFNA1IFNA2, IFNA4IFNA8, IFNA10, IFNA13, IFNA14, IFNA16IFNA17, IFNA21, IFNB1, IFNB3, IFNG, IFNK, IFNW1 Interferon receptors: IFNAR1, IFNAR2, IFNGR1, IFNGR2|Baseline|Genotyping was not conducted because of insufficient resources.|||||
839824|NCT01328496|Secondary|The Number of Participants With Transplant-related Morbidity|Any patient who had adverse events listed either as probable or definite in the first 100 days post-transplant are counted as transplant related morbidity. The number of patients with transplant-related morbidity was given.|first 100 days post transplant|||Participants|||Count of Participants
839825|NCT01328496|Secondary|Incidence of Transplant-related Mortality (TRM)|TRM is death occurring in patients in continuous complete remission. The numbers of patients with TRM was given.|first 100 days post transplant|||Participants|||Count of Participants
839826|NCT01328496|Secondary|Time to Engraftment of Research Arm Participants|Platelet engraftment was defined as platelet count ≥20,000/mm^3 for 3 consecutive tests performed on different days with no platelet transfusions in the preceding 7 days. Neutrophil engraftment will be defined as achieving ANC ≥ 500/mm3 for 3 consecutive tests performed on different days with evidence of donor cell engraftment. Descriptive statistics are provided.|first 100 days post transplant|Those patients who did not reach engraftment are not included in the results provided below.||Days||Standard Deviation|Mean
839827|NCT01328496|Secondary|Number of Participants With Chronic GVHD|Due to the small sample size, cumulative incidence analysis was not done. The incidence of chronic GVHD was evaluated using NIH Consensus Global Severity Scoring. The number of patients with incidence of chronic GVHD by severity was provided.|1 year|||Participants|||Count of Participants
839828|NCT01328496|Secondary|Number of Participants With Acute GVHD|The number of participants with incidence of acute GVHD by grade was given. Participants are graded on a scale from 1 to 4, with 1 being mild and 4 being severe.|1 year|||Participants|||Count of Participants
839829|NCT01328496|Secondary|Number of Observational Arm Patients With Transplant-related Mortality (TRM)|The number of patients with TRM within the first 100 days post transplant was given.|First 100 days|||Participants|||Count of Participants
839830|NCT01328496|Secondary|Number of Deaths of Observational Arm Patients|The number of observational arm patients who died was given.|1 year|||Participants|||Count of Participants
839831|NCT01328496|Secondary|Number of Observational Arm Patients Who Relapsed|The number of observational arm patients who relapsed was given.|1 year|||Participants|||Count of Participants
839832|NCT01328496|Secondary|Number of Observational Arm Participants Engrafted|For patients enrolled in the observational arm (undergoing a double unit UCBT), the number of patients engrafted was given.|1 year|||Participants|||Count of Participants
841678|NCT01347580|Secondary|Major Bleeds After 48 Hours|non CABG related bleeds (PLATO definition) include life threatening and other major bleedings|after 48hours post-first dose|safety||patients|||Number
839838|NCT01328548|Primary|Assessment of Immune Parameters Compatible With Inflammaging: High T Regulatory Cells|Characterization of T-cell populations will be conducted on whole blood using multi-parametric flow cytometry prior to immunization to characterize the immunological function of circulating T-cells in the nursing home vaccine group.|Baseline|Predictor variables were assessed only among the frail elderly, the community control group served as a control for immunogenicity only.||% of peripheral blood mononuclear cell||Standard Deviation|Mean
839839|NCT01328548|Primary|Assessment of Immune Parameters Compatible With Inflammaging: CD4+/CD8+ Ratio|Characterization of T-cell populations will be conducted on whole blood using multi-parametric flow cytometry prior to immunization to characterize the immunological function of circulating T-cells in the nursing home vaccine group.|Baseline|Predictor variables were assessed only among the frail elderly, the community control group served as a control for immunogenicity only.||T-cell ratio||Standard Deviation|Mean
839840|NCT01328548|Primary|Change From Baseline in T-cell Response to the VZV Vaccine in the Frail Elderly|As the primary phenotype, we will compare change in Enzyme-linked immunosorbent spot (ELISPOT) from baseline (i.e., pre and post vaccination). A high baseline T cell response will be defined as ELISPOT = >50 spots and a low baseline response will be ELISPOT = <10 spots.|6 weeks|IFN-gamma T cell ELISpot assay (sfu) against VZV taken prior to vaccination and 6 weeks post vaccination||Spot Forming Units per 10^6 PBMC||Standard Deviation|Mean
839841|NCT01328574|Secondary|Incidence of TRC-105-Related Adverse Events|Adverse events by grade, (e.g. 1 is mild, 2 is moderate, 3 is severe and 4 is life threatening) related to TRC-105.|24 months|||participants|||Number
839842|NCT01328574|Secondary|Median Overall Survival|Date of on-study to the date of death from any cause or last follow up.|up to 25 months|||Months||95% Confidence Interval|Median
839843|NCT01328574|Secondary|Objective Response|Objective response is defined as the number of participants who meet the criteria for a complete response (CR) or a partial response (PR) per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.|up to 25 months|||participants|||Number
839844|NCT01328574|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|24 months|||participants|||Number
839845|NCT01328574|Primary|Progression Free Survival|Time interval from start of treatment to documented evidence of disease progression. Progressive disease is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (Note: the appearance of one or more new lesions is also considered progression).-|after 6 months on study|||Months||95% Confidence Interval|Median
839846|NCT01329185|Primary|Incidence of EBV or CMV Related Disease in Transplant Recipient|Incidence of EBV or CMV related disease in the transplant recipients of enrolled donors.|At least 1 year|||participants|||Number
839847|NCT01329198|Secondary|Correlation of Tics and Neural Physiology|Electrical recordings of electroencephalography activity were taken from each subject's implanted leads at each visit from baseline to 6 months. At baseline, the recordings were taken with the device in the off state (not stimulating), while at the 6 month visits the recordings were taken with the subject's device set to optimal parameters for tic control. Using Pearson's correlation coefficient, the variations in frequency and power which were observed were correlated with the Yale Global Tic Severity (YGTSS) scores obtained during primary outcome testing.|Baseline to 6 Months|||Pearson Correlation Coefficient|||Number
839848|NCT01329198|Primary|Mean Change in Yale Global Tic Severity Scale (YGTSS) Scores From Baseline to 6 Months Across All Study Participants Presented|"The Yale Global Tic Severity Scale (YGTSS) is a semistructured clinician-rated instrument that assesses the severity and frequency of motor and phonic tics over the previous week. Five index scores are obtained during the assessment, where higher scores indicate greater frequency or severity. These indices are:
Total Motor Tic Score (0-25)
Total Phonic Tic Score (0-25
Total Tic Score (0-50)
Overall Impairment Rating (0-50)
Global Severity Score (0-7)
The YGTSS Total Score is obtained by adding the Total Tic Score to the Overall Impairment Rating. The efficacy of the intervention will be assessed by comparing each subject's 6-month YGTSS Total Score to the pre-operative value for the same patient. Efficacy is considered 50% or greater reduction in this score."|Baseline to 6 Months|||units on a scale||95% Confidence Interval|Mean
839849|NCT01329263|Primary|Subjective Rating of Cigarettes|Subjects completed a visual analog scale rating each cigarette smoked at each session. Subjects rated characteristics of the cigarette on a scale represented as a continuous horizontal line 10 cm long. Subjects drew an intersecting line to represent their rating. The rating reported is for the taste of the cigarette at the end of the period averaged across subjects in the group. A rating of 0 corresponds to Very Bad and a rating of 100 to Very Good for taste. There is no better or worse outcome for higher or lower ratings for taste.|Immediately after a cigarette smoked at the study session|Completed measure||units on a scale||Standard Error|Mean
839850|NCT01329263|Primary|Nicotine Levels|Urine nicotine levels will be measured to examine the effect of cigarette menthol on harm exposure measures. Participants provided samples on the final day of each period. NNK and 1-hop were not analyzed, total nicotine metabolites were assayed.|35 days|Those completing Day 5, returning sample for assay||micrograms/mL||Standard Error|Mean
839851|NCT01329263|Primary|Smoking Topography- Carbon Monoxide Boost|Carbon monoxide content in exhaled breath samples is measured before and after each cigarette smoked during study sessions. CO boost is the amount in parts per million that the subject's CO increases.|Measured before and after each cigarette smoked at study sessions|||parts per million||Standard Error|Mean
839852|NCT01329263|Primary|Smoking Topography- Puff Volume|The total puff volume for a single subject is the sum of puff volumes for a subject's cigarette smoked during the study session. The mean puff volume for the subjects will be used to examine the effect of cigarette menthol on smoking topography. The values provided are the average of subjects at study Day 5 (completion of baseline smoking own cigarettes), Day 20 and Day 35.|over 35 day study period|Those completing Study session 2 at Day 5.||mL||Standard Error|Mean
841679|NCT01347580|Secondary|Minor and Major Bleedings Within 48 Hours|non CABG related bleeds (PLATO definition)|within 48 hours of first dose|Safety||patients|||Number
839853|NCT01329419|Secondary|Number of Participants With the Indicated Unexpected Adverse Events|An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Unexpected adverse events include those not listed in the approved product information and not described as precautions or warnings.|12 weeks|ITT Population||participants|||Number
839854|NCT01329419|Secondary|Number of Participants With a Serious Adverse Event|"A serious adverse event is any untoward medical occurrence that, at any dose: results in death /is life-threatening; requires hospitalization or prolongation of exixting hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is another medically significant event. For a list of all serious adverse events occurring during the course of the study, please see the table entitled Serious Adverse Events in the Adverse Event section of the results record."|12 weeks|ITT Population||participants|||Number
839855|NCT01329419|Primary|Number of Participants With an Adverse Event|"An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. For a list of all adverse events occurring during the course of the study, please see the table entitled Other (non-serious) adverse events in the Adverse Event section of the results record."|12 weeks|Intent-to-Treat (ITT) Population: all participants who had been administered the investigational drug at least once and had undergone all safety assessments||participants|||Number
839856|NCT01329549|Secondary|Apparent Volume of Distribution at Steady State (Vss)|"Vss was evaluated for doxorubicin, free platinum, total platinum. Descriptive statistics were not calculated in the study report.
total platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31, 46.917,166.917, 334.917, and 502.917 hours after start of infusion of carboplatin in Cycle 1 and 2
free platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31 hours after start of infusion of carboplatin in Cycle 1 and 2
PLD: pre-dose, 0.5, 1, 1.5, 2, 2.25, 2.75, 3.25, 4.5, 6.5, 8, 9.5, 25, 27, 30, 34, 47.917, 167.917, 335.917, and 503.917 hours after start of infusion of PLD in Cycle 1 and 2"|0.5h after the start of the infusion up to 56 days|Treated set|||||
839857|NCT01329549|Secondary|Total Plasma Clearance (CL)|"CL was evaluated for doxorubicin, free platinum, total platinum. Descriptive statistics were not calculated in the study report.
Detailed outcome measure time frame:
total platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31, 46.917,166.917, 334.917, and 502.917 hours after start of infusion of carboplatin in Cycle 1 and 2
free platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31 hours after start of infusion of carboplatin in Cycle 1 and 2
PLD: pre-dose, 0.5, 1, 1.5, 2, 2.25, 2.75, 3.25, 4.5, 6.5, 8, 9.5, 25, 27, 30, 34, 47.917, 167.917, 335.917, and 503.917 hours after start of infusion of PLD in Cycle 1 and 2"|0.5h after the start of the infusion up to 56 days|Treated set|||||
839858|NCT01329549|Secondary|Terminal Half-life (t1/2)|"t1/2 was evaluated for nintedanib (BIBF 1120 BS, BIBF 1202 ZW), PLD (doxorubicin), and carboplatin (free platinum, total platinum). Descriptive statistics were not calculated in the study report.
Detailed outcome measure time frame:
total platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31, 46.917,166.917, 334.917, and 502.917 hours after start of infusion of carboplatin in Cycle 1 and 2
free platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31 hours after start of infusion of carboplatin in Cycle 1 and 2
PLD: pre-dose, 0.5, 1, 1.5, 2, 2.25, 2.75, 3.25, 4.5, 6.5, 8, 9.5, 25, 27, 30, 34, 47.917, 167.917, 335.917, and 503.917 hours after start of infusion of PLD in Cycle 1 and 2
nintedanib and its metabolites: pre-dose, 1, 2, 3, 4, 6, 8, 10, 23.917 hours after first administration of nintedanib in Cycle 1 and 2"|0.5h after the start of the infusion up to 56 days|Treated set|||||
839859|NCT01329549|Secondary|Time From Dosing to the Maximum Plasma Concentration (Tmax)|"tmax was evaluated for nintedanib (BIBF 1120 BS, BIBF 1202 ZW, BIBF 1202 glucuronide), PLD (doxorubicin), and carboplatin (free platinum, total platinum). Descriptive statistics were not calculated in the study report.
Detailed outcome measure time frame:
total platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31, 46.917,166.917, 334.917, and 502.917 hours after start of infusion of carboplatin in Cycle 1 and 2
free platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31 hours after start of infusion of carboplatin in Cycle 1 and 2
PLD: pre-dose, 0.5, 1, 1.5, 2, 2.25, 2.75, 3.25, 4.5, 6.5, 8, 9.5, 25, 27, 30, 34, 47.917, 167.917, 335.917, and 503.917 hours after start of infusion of PLD in Cycle 1 and 2
nintedanib and its metabolites: pre-dose, 1, 2, 3, 4, 6, 8, 10, 23.917 hours after first administration of nintedanib in Cycle 1 and 2"|0.5h after the start of the infusion up to 56 days|Treated set|||||
839860|NCT01329549|Secondary|Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero Extrapolated to Infinity (AUC0-∞)|"AUC0-∞ was evaluated for nintedanib (BIBF 1120 BS, BIBF 1202 ZW), PLD (doxorubicin), and carboplatin (free platinum, total platinum). Descriptive statistics were not calculated in the study report.
Detailed outcome measure time frame
total platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31, 46.917,166.917, 334.917, and 502.917 hours after start of infusion of carboplatin in Cycle 1 and 2
free platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31 hours after start of infusion of carboplatin in Cycle 1 and 2
PLD: pre-dose, 0.5, 1, 1.5, 2, 2.25, 2.75, 3.25, 4.5, 6.5, 8, 9.5, 25, 27, 30, 34, 47.917, 167.917, 335.917, and 503.917 hours after start of infusion of PLD in Cycle 1 and 2
nintedanib and its metabolites: pre-dose, 1, 2, 3, 4, 6, 8, 10, 23.917 hours after first administration of nintedanib in Cycle 1 and 2"|0.5h after the start of the infusion up to 56 days|Treated set|||||
839861|NCT01329549|Secondary|Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to the Time of the Last Quantifiable Drug Concentration (AUC0-tz)|"AUC0-tz was evaluated for nintedanib (BIBF 1120 BS, BIBF 1202 ZW, BIBF 1202 glucuronide), PLD (doxorubicin), and carboplatin (free platinum, total platinum). Descriptive statistics were not calculated in the study report.
Detailed outcome measure time frame:
total platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31, 46.917,166.917, 334.917, and 502.917 hours after start of infusion of carboplatin in Cycle 1 and 2
free platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31 hours after start of infusion of carboplatin in Cycle 1 and 2
PLD: pre-dose, 0.5, 1, 1.5, 2, 2.25, 2.75, 3.25, 4.5, 6.5, 8, 9.5, 25, 27, 30, 34, 47.917, 167.917, 335.917, and 503.917 hours after start of infusion of PLD in Cycle 1 and 2
nintedanib and its metabolites: pre-dose, 1, 2, 3, 4, 6, 8, 10, 23.917 hours after first administration of nintedanib in Cycle 1 and 2"|0.5h after the start of the infusion up to 56 days|Treated set|||||
839862|NCT01329549|Secondary|Maximum Measured Plasma Concentration (Cmax)|"Cmax was evaluated for nintedanib (BIBF 1120 BS, BIBF 1202 ZW, BIBF 1202 glucuronide), PLD (doxorubicin), and carboplatin (free platinum, total platinum). This endpoint has not been statistically analyzed in the study report.
Detailed outcome measure time frame:
total platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31, 46.917,166.917, 334.917, and 502.917 hours after start of infusion of carboplatin in Cycle 1 and 2
free platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31 hours after start of infusion of carboplatin in Cycle 1 and 2
PLD: pre-dose, 0.5, 1, 1.5, 2, 2.25, 2.75, 3.25, 4.5, 6.5, 8, 9.5, 25, 27, 30, 34, 47.917, 167.917, 335.917, and 503.917 hours after start of infusion of PLD in Cycle 1 and 2
nintedanib and its metabolites: pre-dose, 1, 2, 3, 4, 6, 8, 10, 23.917 hours after first administration of nintedanib in Cycle 1 and 2"|0.5h after the start of the infusion up to 56 days|Treated set|||||
839863|NCT01329549|Primary|Dose Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD) of Nintedanib|to determine the MTD of nintedanib in combination with carboplatin (AUC 5 mg/mL·min) and PLD (30 mg/m2) reflected by the number of DLTs per dose level. This endpoint has not been statistically analyzed in the study report.|28 days|Treated set|||||
839864|NCT01329562|Secondary|Correlation of Mean Estrogen Levels in Saliva and Urine Estradiol at Mid-Luteal and at Menstrual Migraine Headache Free in Responders vs Non-Responders|"Correlation of mean estrogen levels in saliva and urine estradiol at mid-luteal, menstrual migraine headache onset* and at migraine headache free following treatment in responders vs. non-responders**.
*Urine estradiol levels were not collected at migraine onset, therefore; correlations could not be completed for that time point.
***A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment.
A non-responder is one that fails to meet the responder criteria."|From mid luteal phase and for the duration of 1 menstrual migraine until headache free.|Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors.||pg/mL||Standard Deviation|Mean
839865|NCT01329562|Secondary|α-Amylase Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders|"α-Amylase levels collected for 1 menstrual migraine at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders**.
*This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure.
**A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment.
A non-responder is one that fails to meet the responder criteria."|From Baseline from 24 hours post migraine gone for 1 menstrual migraine.|Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors.||U/L||Standard Deviation|Mean
839866|NCT01329562|Secondary|CGRP Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders|"CGRP levels collected for 1 menstrual migraine headache at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders**.
*This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure.
**A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment.
A non-responder is one that fails to meet the responder criteria."|From Baseline to 24 hours post headache gone for 1 menstrual migraine.|Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors.||pmol/mg||Standard Deviation|Mean
839867|NCT01329562|Secondary|Biomarkers Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders|"VIP, PGE2, Cortisol, PGI2, Estradiol, and β-endorphin** levels collected for 1 menstrual migraine headache at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders***.
*This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure. CGRP and α-amylase both have their own outcome measure reported individually.
**β-endorphin levels were not assayed due to limitations on saliva sample volumes.
***A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment. A non-responder is one that fails to meet the responder criteria."|From Baseline for the duration of 1 menstrual migraine headache, an estimated 7 days|Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors.||pg/mL||Standard Deviation|Mean
839868|NCT01329562|Primary|Correlation of Mean Estrogen Levels in Saliva and Urine Estradiol at Mid Luteal and at Menstrual Migraine Headache Free.|"Correlation of mean estrogen levels in saliva and urine estradiol at mid luteal, menstrual migraine headache onset*, and at migraine headache free following treatment with Treximet vs. Placebo for 1 menstrual migraine headache
*Urine estradiol levels were not collected at migraine onset, therefore; correlations could not be completed for that time point."|From mid luteal phase and for the duration of 1 menstrual migraine headache and until headache free|Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors.||pg/mL||Standard Deviation|Mean
839869|NCT01329562|Primary|α-Amylase Measured at Menstrual Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free.|"α-Amylase levels collected at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Treximet vs. Placebo arm for 1 menstrual migraine headache
* This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure."|From baseline to 24 hours post headache gone for 1 menstrual migraine headache|In Group B, one subject's sample was unable to be analyzed by the laboratory, therefore Group B has one less subject in the placebo arm (N=10) for all biomarker data.||U/L||Standard Deviation|Mean
839896|NCT01329939|Secondary|Serum Leptin Levels|Leptin levels, measured through blood, mediate appetite and are elaborated by adipose tissue. Levels correlate positively with body fat percentage. In addition, leptin plays a role in producing an inflammatory state. Adiponectin, which is also secreted by adipose tissue, regulates metabolism, however its levels are inversely correlated with body fat percentage.|24 weeks|||ng/mL||95% Confidence Interval|Mean
839870|NCT01329562|Primary|CGRP Measured at Menstrual Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free.|"CGRP levels collected at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Treximet vs. Placebo arm for 1 menstrual migraine headache.
* This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure."|From baseline to 24 hours post headache gone for 1 menstrual migraine headache|In Group B, one subject's sample was unable to be analyzed by the laboratory, therefore Group B has one less subject in the placebo arm (N=10) for all biomarker data.||pmol/mg||Standard Deviation|Mean
839871|NCT01329562|Primary|Biomarkers Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free.|"VIP, PGE2, Cortisol, PGI2, Estradiol, and β-endorphin** levels collected at Menstrual Migraine Headache Onset, Migraine Headache Free and 24 Hours Migraine Headache Free in Treximet vs. Placebo arm for 1 menstrual migraine headache.
* This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure. CGRP and α-amylase both have their own outcome measure reported individually.
**β-endorphin levels were not assayed due to limitations on saliva sample volumes."|From baseline to 24 hours post headache gone for 1 menstrual migraine headache.|In Group B, one subject's sample was unable to be analyzed by the laboratory, therefore Group B has one less subject in the placebo arm (N=10) for all biomarker data.||pg/mL||Standard Deviation|Mean
839872|NCT01329562|Secondary|α-Amylase Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment in Responders vs Non-Responders|"α-Amylase levels collected at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment in Responders vs Non-Responders*.
*A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment.
A non-responder is one that fails to meet the responder criteria."|From Baseline until 2 hours post treatment of 1 menstrual migraine headache.|Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors.||U/L||Standard Deviation|Mean
839873|NCT01329562|Secondary|CGRP Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post-Treatment in Responders vs Non-Responders|"CGRP levels collected for 1 menstrual migraine headache at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post-Treatment in Responders vs Non-Responders**.
*This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure.
**A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment.
A non-responder is one that fails to meet the responder criteria."|From Baseline until 2 Hours post menstrual migraine treatment for 1 menstrual migraine headache.|Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors.||pmol/mg||Standard Deviation|Mean
839874|NCT01329562|Secondary|Biomarkers Measured at Baseline, Menstrual Migraine Onset, and 2 Hours Post Treatment in Responders vs Non-Responders|"VIP, PGE2, Cortisol, PGI2, Estradiol, and β-endorphin** levels collected for 1 menstrual migraine headache at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment in Treximet vs. Placebo arms in responders vs. non-responders***.
*This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same unit of measure. CGRP and α-amylase both have their own outcome measure reported individually.
**β-endorphin levels were not assayed due to limitations on saliva sample volumes.
***A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment.
A non-responder is one that fails to meet the responder criteria."|From Baseline until 2 Hours post menstrual migraine treatment for 1 menstrual migraine headache.|Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors.||pg/mL||Standard Deviation|Mean
839875|NCT01329562|Secondary|Time to Pain-Free in Responders vs Non-Responders|"Duration of time from treatment at menstrual migraine headache onset until pain-free in Treximet vs. Placebo arms in responders* vs. non-responders for 1 menstrual migraine.
0-3 Pain Scale, with 0=No Pain, 1=Mild, 2=Moderate, and 3=Severe.
*A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment.
A non-responder is one that fails to meet the responder criteria."|From the onset of 1 menstrual migraine headache until pain-free.|||hours||Standard Deviation|Mean
839876|NCT01329562|Secondary|Migraine Recurrence Responders vs Non-Responders|"Number of subjects either pain-free or mild at 2 hours then pain level increases within 24 hours following treatment in Treximet vs. Placebo arm for 1 menstrual migraine headache with Treximet vs. Placebo in responders* vs. non-responders.
0-3 Pain Scale with 0=No Pain, 1=Mild, 2=Moderate, and 3=Severe
*A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment.
A non-responder is one that fails to meet the responder criteria."|From the onset of 1 menstrual migraine until 24 hours post treatment.|||participants|||Number
839877|NCT01329562|Primary|α-Amylase Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment|"α-Amylase levels collected at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment in Treximet vs. Placebo arm for 1 menstrual migraine headache
* This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure."|From Baseline until 2 hours post treatment for 1 menstrual migraine headache|In Group B, one subject's sample was unable to be analyzed by the laboratory, therefore Group B has one less subject in the placebo arm (N=10) for all biomarker data. Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors.||U/L||Standard Deviation|Mean
839895|NCT01329939|Secondary|Urinary Leukotriene E4 (LTE4) Levels|LTE4 levels, measured in the urine, reflect the degree of inflammation in the asthmatic airway. We did not perform percent change from baseline since in a randomized clinical trial, where the groups are comparable at baseline, we can use only the post-treatment (week 24) data in the analysis.|24 weeks|One subject in the normal weight atopic asthmatic group who was receiving placebo did not provide a urine sample at 24 weeks.||pg/mL||95% Confidence Interval|Mean
839878|NCT01329562|Primary|CGRP Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment|"CGRP levels collected at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment in Treximet vs. Placebo arms for 1 menstrual migraine headache
* This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure."|From Baseline until 2 hours post treatment for 1 menstrual migraine headache|In Group B, one subject's sample was unable to be analyzed by the laboratory, therefore Group B has one less subject in the placebo arm (N=10) for all biomarker data. Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors.||pmol/mg||Standard Deviation|Mean
839879|NCT01329562|Primary|Biomarkers Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment|"Vasoactive Intestinal Peptide (VIP), Prostaglandin E2 (PGE2), Cortisol, Prostaglandin I2 (PGI2), Estradiol, and β-endorphin** levels collected at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment in Treximet vs. Placebo arms for 1 menstrual migraine headache * This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure. Calcitonin Gene-Related Peptide (CGRP) and α-amylase both have their own outcome measure reported individually.
**β-endorphin levels were not assayed due to limitations on saliva sample volumes."|From Baseline until 2 hours post treatment of 1 menstrual migraine headache|In Group B, one subject's sample was unable to be analyzed by the laboratory, therefore Group B has one less subject in the placebo arm (N=10) for all biomarker data. Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors.||pg/mL||Standard Deviation|Mean
839880|NCT01329562|Primary|Time to Pain Free|"Duration of 1 menstrual migraine from time of treatment at menstrual migraine headache onset until pain free in Treximet vs. Placebo arms.
0-3 pain scale with 0=No Pain, 1=Mild, 2=Moderate, and 3=Severe."|From onset of 1 menstrual migraine headache until pain free.|In Group B, one subject did not report when their headache resolve, therefore a duration for this subject could not be calculated.||hours||Standard Deviation|Mean
839881|NCT01329562|Primary|Migraine Recurrence|"Number of subjects either pain free or mild at 2 hours then pain level increases within 24 hours following treatment with Treximet versus (vs.) Placebo for 1 menstrual migraine.
0-3 pain scale with 0=No Pain, 1=Mild, 2=Moderate,and 3=Severe."|From onset of a single menstrual migraine episode to 24 hours post menstrual migraine treatment.|||participants|||Number
839882|NCT01329679|Secondary|Max QTc Interval After a Single Energy Shot or Placebo Consumption After Day 1 and After Chronic Consumption After Day 7||At baseline and 7 days post energy drink and placebo consumption|||msec||Standard Deviation|Mean
839883|NCT01329679|Secondary|Max QT Interval After a Single Energy Shot or Placebo Consumption After Day 1 and After Chronic Consumption After Day 7||At baseline and 7 days post energy drink and placebo consumption|||msec||Standard Deviation|Mean
839884|NCT01329679|Secondary|Max QRS Duration After a Single Shot and After Chronic Consumption||At baseline and 7 days post energy drink and placebo consumption|||msec||Standard Deviation|Mean
839885|NCT01329679|Secondary|Max PR-interval After a Single Shot and After Chronic Consumption||At baseline and 7 days post energy drink and placebo consumption|||msec||Standard Deviation|Mean
839886|NCT01329679|Secondary|Max Heart Rate After a Single Shot and After Chronic Consumption||At baseline and 7 days post energy drink and placebo consumption|||beats per minute||Standard Deviation|Mean
839887|NCT01329679|Secondary|Office DBP After a Single Energy Shot and After Chronic Consumption|Office diastolic blood pressure (DBP)|At baseline and 7 days post energy drink and placebo consumption|||mmHg||Standard Deviation|Mean
839888|NCT01329679|Primary|Change in Office Systolic Blood Pressure|SBP = Systolic Blood Pressure measured at baseline (after a single energy shot or placebo consumption) and after chronic consumption for 7 days.|At baseline and 7 days post energy drink and placebo consumption|||mmHg||Standard Deviation|Mean
839889|NCT01329848|Secondary|Conlon Symptom Survey|Measures visual discomfort symptoms while doing near work. 23 item survey using a 4-point rating scale (never, occasionally, often, almost always). Total raw score reported on a range from 0 to 69 with higher scores indicating more frequent symptoms.|3 weeks|||units on a scale||Standard Deviation|Mean
839890|NCT01329848|Primary|Accommodation Lag 5D|Lag will be measured at different viewing distances and durations using autorefraction. Accommodation error refers to the difference between the distance where the target is located and where the eyes focus. Lag refers error that is under focussed; lead is error that is over focussed. This distance is measured in diopters, or 1/meter.|3 week period|||diopters||Standard Deviation|Mean
839891|NCT01329939|Secondary|Urinary Creatinine (Cr) Levels/Leukotriene E4 (LTE4) Ratio|The ratio of urinary LTE4 to Cr provides a standardization of the LTE4 level based on the patients weight and muscle mass, therefore normalizing it across the different subjects. We did not perform percent change from baseline since in a randomized clinical trial, where the groups are comparable at baseline, we can use only the post-treatment (week 24) data in the analysis.|24 weeks|One subject in the normal weight atopic asthmatic group who was receiving placebo did not provide a urine sample at 24 weeks.||pg/mg||95% Confidence Interval|Mean
839892|NCT01329939|Secondary|Urinary Creatinine (Cr) Levels|Creatinine, measured in the urine, reflects how well the kidneys are working, and provide a standard to which one can compare other metabolites in the urine. We did not perform percent change from baseline since in a randomized clinical trial, where the groups are comparable at baseline, we can use only the post-treatment (week 24) data in the analysis.|24 weeks|One subject in the normal weight atopic asthmatic group who was receiving placebo did not provide a urine sample at 24 weeks.||mg/mL||95% Confidence Interval|Mean
839893|NCT01329939|Secondary|Beclomethasone Equivalents|The total daily dose of inhaled corticosteroids in beclomethasone equivalents. We did not perform percent change from baseline since in a randomized clinical trial, where the groups are comparable at baseline, we can use only the post-treatment (week 24) data in the analysis.|24 weeks|||micrograms||95% Confidence Interval|Mean
839894|NCT01329939|Secondary|Exhaled Nitric Oxide Measurement|A non-invasive measure of eosinophilic airway inflammation. We did not perform percent change from baseline since in a randomized clinical trial, where the groups are comparable at baseline, we can use only the post-treatment (week 24) data in the analysis.|24 weeks|||ppb||95% Confidence Interval|Mean
841680|NCT01347580|Secondary|Major Bleeds Within 48 Hours|non CABG related bleeds, (PLATO definition) include Life threatening and other major bleeds|within 48 hours of first dose|Safety||patients|||Number
839898|NCT01329939|Primary|Asthma Control Test (ACT) Scores|The ACT is a validated questionaire-based tool designed to assess asthma control. Scale range for 7-11 year olds is 0-27 and for 12 years and older 5-25, with lower scores indicating poorer asthma control for all ages. We did not perform percent change from baseline since in a randomized clinical trial, where the groups are comparable at baseline, we can use only the post-treatment (week 24) data in the analysis.|24 weeks|||units on a scale||95% Confidence Interval|Mean
839899|NCT01329978|Secondary|Percentage of Participants With Virologic Failure Following Treatment (Viral Relapse).|Viral relapse was defined as HCV RNA < 15 IU/mL at end of treatment, confirmed with 2 consecutive values or last available measurement.|End of treatment to Post-treatment Week 24|Participants in the Safety Analysis Set with available data were analyzed.||percentage of participants|||Number
839900|NCT01329978|Secondary|Percentage of Participants With Virologic Failure During Treatment|"Virologic failure was defined as either
HCV RNA ≥ 15 IU/mL after having previously had HCV RNA < 15 IU/mL while on treatment, confirmed with 2 consecutive values or last available measurement (ie, breakthrough);
> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values or last available measurement (ie, rebound);or
HCV RNA persistently ≥ 15 IU/mL through 8 weeks of treatment (ie, nonresponse)
Baseline was Day 1 for all groups."|Baseline (Day 1) to Week 24|Safety Analysis Set||percentage of participants|||Number
839901|NCT01329978|Secondary|Percentage of Participants With ALT Normalization at Post-treatment Week 4|ALT normalization was defined as ALT > ULN at baseline (Day 1 for all groups) and ALT ≤ ULN at Post-treatment Week 4.|Baseline (Day 1) to Post-treatment Week 4|Participants in the Safety Analysis Set with ALT > ULN at baseline and with available data were analyzed.||percentage of participants|||Number
839902|NCT01329978|Secondary|Percentage of Participants With ALT Normalization at Week 24|ALT normalization was defined as ALT > ULN at baseline (Day 1 for all groups) and ALT ≤ ULN at Week 24.|Baseline (Day 1) to Week 24|Participants in the Safety Analysis Set with ALT > ULN at baseline and with available data were analyzed. No participants in the SOF+PEG+RBV 12 weeks group were analyzed because they received only 12 weeks of treatment.||percentage of participants|||Number
839903|NCT01329978|Secondary|Percentage of Participants With ALT Normalization at Week 12|ALT normalization was defined as ALT > ULN at baseline and ALT ≤ ULN at Week 12.|Baseline (Day 1) to Week 12|Participants in the Safety Analysis Set with ALT > ULN at baseline and with available data were analyzed.||percentage of participants|||Number
839904|NCT01329978|Secondary|Percentage of Participants With HCV RNA Below < LOD at Week 24||Week 24|Participants in the Safety Analysis Set with Available data were analyzed. No participants in the SOF+PEG+RBV 12 weeks group were analyzed because they received only 12 weeks of treatment.||percentage of participants|||Number
839905|NCT01329978|Secondary|Percentage of Participants With HCV RNA Below < LOD at Week 12||Week 12|Participants in the Safety Analysis Set with Available data were analyzed.||percentage of participants|||Number
839906|NCT01329978|Secondary|Percentage of Participants With HCV RNA Below < LOD at Week 8||Week 8|Participants in the Safety Analysis Set with Available data were analyzed.||percentage of participants|||Number
839907|NCT01329978|Secondary|Percentage of Participants With HCV RNA Below < LOD at Week 4||Week 4|Participants in the Safety Analysis Set with Available data were analyzed.||percentage of participants|||Number
839908|NCT01329978|Secondary|Percentage of Participants With HCV RNA < LOD at Week 2||Week 2|Participants in the Safety Analysis Set with Available data were analyzed.||percentage of participants|||Number
839909|NCT01329978|Secondary|Change in HCV RNA at Week 12||Baseline (Day 1) to Week 12|Participants in the Safety Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
839910|NCT01329978|Secondary|Change in HCV RNA at Week 8||Baseline (Day 1) to Week 8|Participants in the Safety Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
839911|NCT01329978|Secondary|Change in HCV RNA at Week 4||Baseline (Day 1) to Week 4|Participants in the Safety Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
839912|NCT01329978|Secondary|Change in HCV RNA at Week 2||Baseline (Day 1) to Week 2|Participants in the Safety Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
839913|NCT01329978|Secondary|Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12)|SVR12 was defined as HCV RNA < LOD 12 weeks after the last dose of study drug.|Post-treatment Week 12|Participants in the Safety Analysis Set with available data were analyzed.||percentage of participants||95% Confidence Interval|Number
839914|NCT01329978|Primary|Percentage of Participants Who Experienced Adverse Events|Adverse events (AEs) occurring from baseline (Day 1 for all groups) to 30 days following the last dose of study drug were summarized across the participant population. A participant was counted once if they had a qualifying event.|Baseline (Day 1) to post-treatment Day 30|Safety Analysis Set||percentage of participants|||Number
839915|NCT01329978|Primary|Percentage of Participants With Sustained Virologic Response 24 Weeks Following Completion of Treatment (SVR24)|SVR24 was defined as HCV RNA < the limit of detection (LOD; < 15 IU/mL) 24 weeks after the last dose of study drug.|Post-treatment Week 24|Participants in the Safety Analysis Set (participants who were randomized and received at least 1 dose of study drug) with genotype 1 and who had available data were analyzed.||percentage of participants||95% Confidence Interval|Number
839916|NCT01330017|Secondary|Change From Baseline for the Instantaneous Nasal Symptom Assessment Score at Day 7|The magnitude of effect was measured as the change from baseline for the instantaneous nasal symptom assessment score at Day 7. Instantaneous assessment of nasal symptoms was performed once daily before the morning dose. The instantaneous assessment was a composite score of four nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing and is rated on a 0-3 scale of severity with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms.|Baseline, Day 7|The ITT population included all randomized participants who received at least 1 dose of study medication.||Units on a Scale||Standard Deviation|Mean
839974|NCT01330381|Secondary|Efficacy of Treatment for Final On Treatment Assessment in Open-Label Treatment Period||Over the 16 week open label treatment period|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome.||percentage of subjects|||Number
839917|NCT01330017|Secondary|Time to Maximal Effect|Time to maximal effect is defined as the earliest time that the nasal congestion symptom score demonstrates the greatest numerical difference from the placebo in change from baseline. The mean change from baseline scores for a treatment arm and for the placebo arm at each day and timepoint of the treatment period (Day 1 morn, Day 1 eve, etc) were calculated. Then the difference between the placebo and treatment arm means at each day/timepoint of the treatment period was calculated and recorded the day/timepoint that the difference between the treatment arm and the placebo was highest.|Baseline up to Day 7|The ITT population included all randomized participants who received at least 1 dose of study medication.||Days|||Number
839918|NCT01330017|Secondary|Mean Change From Baseline for the Instantaneous Nasal Symptom Assessment Score By Study Day of the Treatment Period|"Instantaneous assessment of nasal symptoms was performed once daily before the
morning dose. The instantaneous assessment was a composite score of four nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing and is rated on a 0-3 scale of severity with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms."|Baseline and Days 1, 2, 3, 4, 5, 6, and 7|The ITT population included all randomized participants who received at least 1 dose of study medication.||Units on a Scale||Standard Deviation|Mean
839919|NCT01330017|Secondary|Mean Change From Baseline for the Daily Reflective Nasal Symptom Assessment Score by Study Day of the Treatment Period|The reflective nasal congestion score was captured in participant diaries just before the 8:00 a.m. dose and 12 hours later just before the 8:00 p.m. dose. It is a composite score including four nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing and is rated on a 0-3 scale of severity with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms. The daily reflective nasal congestion symptom score was defined as the average of the morning and evening reflective nasal congestion score for the entire treatment period.|Baseline and Days 1, 2, 3, 4, 5, 6, and 7|The ITT population included all randomized participants who received at least 1 dose of study medication.||Units on a Scale||Standard Deviation|Mean
839920|NCT01330017|Secondary|Mean Change From Baseline in the a.m. Symptom Score for the Instantaneous Nasal Symptom Assessment by Study Day of the Treatment Period|"Instantaneous assessment of nasal symptoms was performed once daily before the
morning dose. The instantaneous assessment was a composite score of four nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing and is rated on a 0-3 scale of severity with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms."|Baseline and Day 2, 3, 4, 5, 6, and 7|The ITT population included all randomized participants who received at least 1 dose of study medication.||Units on a Scale||Standard Deviation|Mean
839921|NCT01330017|Secondary|Mean Change From Baseline in the Evening (p.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period|The evening reflective nasal congestion score was captured in participant diaries just before the 8;00 p.m. dose. It is a composite score including four nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing and is rated on a 0-3 scale of severity with 0 = absent, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms.|Baseline and Days 1, 2, 3, 4, 5, 6, and 7|The ITT population included all randomized participants who received at least 1 dose of study medication.||Units on a Scale||Standard Deviation|Mean
839922|NCT01330017|Secondary|Mean Change From Baseline in the Morning (a.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period|The morning reflective nasal congestion score was captured in participant diaries just before the 8:00 am dose. It is a composite score including four nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing and it is rated on a 0-3 scale of severity with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms.|Baseline and Days 2, 3, 4, 5, 6, and 7|The ITT population included all randomized participants who received at least 1 dose of study medication.||Units on a Scale||Standard Deviation|Mean
839923|NCT01330017|Primary|Mean Change From Baseline Over the Entire Treatment Period in the Daily Reflective Nasal Congestion Score|The reflective nasal congestion score was captured in participant diaries just before the 8:00 a.m. dose and 12 hours later just before the 8:00 p.m. dose. Participants rated congestion on a 4-point scale of severity from 0 (best) to 3 (worst), with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms. The daily reflective nasal congestion symptom score was defined as the average of the morning and evening reflective nasal congestion score for the entire treatment period. Baseline was defined as the average of the daily scores over the 4 consecutive 24-hour periods before randomization.|Baseline, Day 7|The Intent-to-Treat (ITT) population included all randomized participants who received at least 1 dose of study medication.||Units on a Scale||Standard Deviation|Mean
839924|NCT01330030|Primary|Expired-air Carbon Monoxide Confirmed Smoking Abstinence|expired-air carbon monoxide confirmed smoking abstinence at 52 weeks|52 weeks|intention to treat||participants not smoking|||Number
839925|NCT01330043|Secondary|Expired-air CO Verified Point-prevalence Abstinence|Self-reported no smoking in last 7 days verified by CO<10 ppm|104 weeks|||participants|||Number
839926|NCT01330043|Primary|Expired-air CO Verified Point-prevalence Abstinence|Self-reported no smoking in last 7 days verified by CO<10 ppm|52 weeks|||participants|||Number
839927|NCT01330108|Secondary|Mean Change in Distance for a Six Minute Walk at 12 Weeks Post Start of Ambrisentan|Evaluate the change in exercise tolerance. Measured the distance a subject was capable of walking in 6 minutes at basline compared to the distance at 12 weeks. The distance was measured in meters. A postive result reflects the distance increased at 12 weeks, a negative result reflects how much shorter the distance was.|baseline to 12 weeks|||meters||Full Range|Mean
839928|NCT01330108|Primary|Number of Subjects Not Able to Tolerate Ambrisentan|If a subject was not able tolerate ambrisentan, subject was returned to use of bosentan and ambrisentan was withdrawn within first 12 weeks of start. A subject was considered to not be able to tolerate ambrisentan if they experienced an adverse event or side effect that was not acceptable to the subject.|baseline to 12 weeks|||participants|||Number
839975|NCT01330381|Secondary|Efficacy of Treatment for Final On Treatment Assessment in Double-Blind Treatment Period||Over the 8 week double blind treatment period|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome.||percentage of subjects|||Number
841681|NCT01347580|Secondary|Thrombotic Bail-out With GPIIb/IIIa Inhibitors at Initial PCI|Glycoprotein (GP) IIb/IIIa inhibitors are often used as a rescue or bailout therapy to manage complications arising during percutaneous coronary intervention.|during PCI|mITT||patients|||Number
839929|NCT01330290|Secondary|Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Care-giving Efforts|"This individual question from the caregivers' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.
Each caregiver could have assessed one or multiple participants. The scores from each caregiver were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the caregivers."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct caregiver was calculated and used for analysis.||units on a scale|Participants|Standard Deviation|Mean
839930|NCT01330290|Secondary|Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication With Regard to Sleeping Patients|"This individual question from the caregivers' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.
Each caregiver could have assessed one or multiple participants. The scores from each caregiver were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the caregivers."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct caregiver was calculated and used for analysis.||units on a scale|Participants|Standard Deviation|Mean
839931|NCT01330290|Secondary|Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication With Regard to Independency of Food Administration|"This individual question from the caregivers' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.
Each caregiver could have assessed one or multiple participants. The scores from each caregiver were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the caregivers."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct caregiver was calculated and used for analysis.||units on a scale|Participants|Standard Deviation|Mean
839932|NCT01330290|Secondary|Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Multiple Medication in Patients With Multiple Medication|"This individual question from the caregivers' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.
Each caregiver could have assessed one or multiple participants. The scores from each caregiver were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the caregivers."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct caregiver was calculated and used for analysis.||units on a scale|Participants|Standard Deviation|Mean
839933|NCT01330290|Secondary|Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Control of Compliance|"This individual question from the caregivers' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.
Each caregiver could have assessed one or multiple participants. The scores from each caregiver were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the caregivers."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct caregiver was calculated and used for analysis.||units on a scale|Participants|Standard Deviation|Mean
839934|NCT01330290|Secondary|Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Nausea and/or Vomiting in Patients With Nausea and/or Vomiting|"This individual question from the caregivers' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.
Each caregiver could have assessed one or multiple participants. The scores from each caregiver were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the caregivers."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct caregiver was calculated and used for analysis.||units on a scale|Participants|Standard Deviation|Mean
841682|NCT01347580|Secondary|ST Segment Elevation Resolution Post-PCI >= 70%|ST segment elevation resolution post PCI >=70% is defined as complete resolution|Between baseline and ECG 60 mn post-PCI|mITT on patients with non missing ECG values||patients|||Number
839935|NCT01330290|Secondary|Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Dysphagia in Patients With Dysphagia|"This individual question from the caregivers' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.
Each caregiver could have assessed one or multiple participants. The scores from each caregiver were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the caregivers."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct caregiver was calculated and used for analysis.||units on a scale|Participants|Standard Deviation|Mean
839936|NCT01330290|Secondary|Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Resorption|"This individual question from the physicians' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.
Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct physician was calculated and used for analysis.||units on a scale|Participants|Standard Deviation|Mean
839937|NCT01330290|Secondary|Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Risk of Interaction With Other Treatments|"This individual question from the physicians' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.
Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct physician was calculated and used for analysis.||units on a scale|Participants|Standard Deviation|Mean
839938|NCT01330290|Secondary|Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication With Regard to Sleeping Patients|"This individual question from the physicians' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.
Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct physician was calculated and used for analysis.||units on a scale|Participants|Standard Deviation|Mean
839939|NCT01330290|Secondary|Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication With Regard to Independency of Food Administration|"This individual question from the physicians' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.
Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct physician was calculated and used for analysis.||units on a scale|Participants|Standard Deviation|Mean
839940|NCT01330290|Secondary|Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Dose Adaption|"This individual question from the physicians' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.
Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct physician was calculated and used for analysis.||units on a scale|Participants|Standard Deviation|Mean
841683|NCT01347580|Secondary|TIMI Flow Grade 3 Post -PCI|TIMI) flow grade 3 is complete perfusion post-PCI.|at coroangiography post-PCI|mITT, on patients with non missing TIMI flow grade values||patients|||Number
839941|NCT01330290|Secondary|Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Surgery Requiring General Anaesthesia|"This individual question from the physicians' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.
Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct physician was calculated and used for analysis.||units on a scale|Participants|Standard Deviation|Mean
839942|NCT01330290|Secondary|Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Multiple Medication in Patients With Multiple Medication|"This individual question from the physicians' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.
Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct physician was calculated and used for analysis.||units on a scale|Participants|Standard Deviation|Mean
839943|NCT01330290|Secondary|Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Control of Compliance|"This individual question from the physicians' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.
Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct physician was calculated and used for analysis.||units on a scale|Participants|Standard Deviation|Mean
839944|NCT01330290|Secondary|Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Nausea and/or Vomiting in Patients With Nausea and/or Vomiting.|"This individual question from the physicians' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.
Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct physician was calculated and used for analysis.||units on a scale|Participants|Standard Deviation|Mean
839945|NCT01330290|Secondary|Score for the Physicians’ Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Dysphagia in Patients With Dysphagia|"This individual question from the caregivers' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.
Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct physician was calculated and used for analysis.||units on a scale|Participants|Standard Deviation|Mean
839946|NCT01330290|Secondary|Assessment of the Physicians' Rationale for the Choice of Neupro® Due to Application Form in Idiopathic Parkinsons Disease Patients Requiring Caregiver Support|"The physician was asked if he / she prescribed Neupro® due to application form in idiopathic Parkinson's Disease patients requiring caregiver support. The possible answers were applicable and not applicable."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires.||participants|||Number
839976|NCT01330381|Secondary|Severity of Constipation Over the Past 2 Weeks for the Final On Treatment Assessment in the Open-Label Treatment Period||2 weeks|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome.||percentage of subjects|||Number
839947|NCT01330290|Secondary|Assessment of the Physicians' Rationale for the Choice of Neupro® Due to Substance in Idiopathic Parkinsons Disease Patients Requiring Caregiver Support|"The physician was asked if he / she prescribed Neupro® due to substance in idiopathic Parkinson's Disease patients requiring caregiver support. The possible answers were applicable and not applicable."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires.||participants|||Number
839948|NCT01330290|Primary|Mean Score of the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication|"The physicians were asked to fill out a questionnaire composed of 10 questions covering medical and caregiving aspects. The mean score is calculated from the scores for the single responses which are rated from 'great disadvantages' to 'great advantages' and scored on a 5-point scale from -2 to +2.
Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct physician was calculated and used for analysis.||units on a scale|Participants|Standard Deviation|Mean
839949|NCT01330290|Primary|Mean Score of the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication|"The caregivers were asked to fill out a questionnaire composed of 7 questions covering caregiving aspects. The mean score is calculated from the scores for the single responses which are rated from 'great disadvantages' to 'great advantages' and scored on a 5-point scale from -2 to +2.
Each caregiver could have assessed one or multiple participants. The scores from each caregiver were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the caregivers."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct caregiver was calculated and used for analysis.||units on a scale|Participants|Standard Deviation|Mean
839950|NCT01330303|Primary|Cmax|Cmax is defined as the maximum or “peak” concentration of a drug observed after its administration. Cmax is one of the parameters of particular use in estimating the bioavailability of drugs, by measuring the total amount of drug absorbed.|Day 1 (day that blood collections started) to Day 4 (Period 1) and Days 8 to 11 (Period 2)|Participants who completed the study||ng/ml||Standard Deviation|Mean
839951|NCT01330303|Primary|AUC0-infinity|The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC from time 0 (prior to administration of medication) to infinity (the time of complete elimination of the drug) was calculated using the trapezoidal method. This method consists of the sum of the trapezoids' areas, determined by the collection times and their concentrations. The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption.|Day 1 (day that blood collections started) to Day 4 (Period 1) and Days 8 to 11 (Period 2)|Participants who completed the study||ng.h/ml||Standard Deviation|Mean
839952|NCT01330303|Primary|AUC 0-t|The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC from time 0 (prior to administration of medication) to time t (the time of the last quantifiable concentration) was calculated using the trapezoidal method. This method consists of the sum of the trapezoids' areas, determined by the collection times and their concentrations. The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. ng, nanograms; ml, milliliter.|Day 1 (day that blood collections started) to Day 4 (Period 1) and Days 8 to 11 (Period 2)|Participants who completed the study||ng per hour per ml (ng.h/ml)||Standard Deviation|Mean
839953|NCT01330316|Secondary|Changes From Baseline in Laboratory Test Values Over Time [Bilirubin Total]|"This outcome measure will be presented as the mean value and the standard deviation at baseline, week 4, week 12, the minimum (min) value on treatment, maximum (max) value on treatment and last measured value on treatment. Analytes with particular relevance for patients with HCF have been selected: Haemoglobin, Alanine aminotransaminase (ALT), Aspartate aminotransaminase (AST) and Bilirubin total.
In this outcome measure Bilirubin total is presented."|baseline (the last observed measurement prior to administration of any randomised study medication), week 4, week 12 (after start of treatment)|FAS||milligram (mg)/dL||Standard Deviation|Mean
839954|NCT01330316|Secondary|Changes From Baseline in Laboratory Test Values Over Time [AST]|"This outcome measure will be presented as the mean value and the standard deviation at baseline, week 4, week 12, the minimum (min) value on treatment, maximum (max) value on treatment and last measured value on treatment. Analytes with particular relevance for patients with HCF have been selected: Haemoglobin, Alanine aminotransaminase (ALT), Aspartate aminotransaminase (AST) and Bilirubin total.
In this outcome measure AST is presented."|baseline (the last observed measurement prior to administration of any randomised study medication), week 4, week 12 (after start of treatment)|FAS||U/L||Standard Deviation|Mean
839955|NCT01330316|Secondary|Changes From Baseline in Laboratory Test Values Over Time [ALT]|"This outcome measure will be presented as the mean value and the standard deviation at baseline, week 4, week 12, the minimum (min) value on treatment, maximum (max) value on treatment and last measured value on treatment. Analytes with particular relevance for patients with HCF have been selected: Haemoglobin, Alanine aminotransaminase (ALT), Aspartate aminotransaminase (AST) and Bilirubin total.
In this outcome measure ALT is presented."|baseline (the last observed measurement prior to administration of any randomised study medication), week 4, week 12 (after start of treatment)|FAS||Units (U)/Litre (L)||Standard Deviation|Mean
839956|NCT01330316|Secondary|Changes From Baseline in Laboratory Test Values Over Time [Haemoglobin]|"This outcome measure will be presented as the mean value and the standard deviation at baseline, week 4, week 12, the minimum (min) value on treatment, maximum (max) value on treatment and last measured value on treatment. Analytes with particular relevance for patients with HCF have been selected: Haemoglobin, Alanine aminotransaminase (ALT), Aspartate aminotransaminase (AST) and Bilirubin total.
In this outcome measure Haemoglobin is presented."|baseline (the last observed measurement prior to administration of any randomised study medication), week 4, week 12 (after start of treatment)|FAS||gram (g)/decilitre (dL)||Standard Deviation|Mean
839957|NCT01330316|Secondary|Laboratory Test Abnormalities by DAIDS Grades|This Outcome measure will be presented as summary of the percentage of patients with worst on-treatment Division of Acquired Immunodeficiency Syndrome (DAIDS) grade laboratory abnormalities for selected analytes (Haemoglobin, Alanine aminotransaminase (ALT), Aspartate aminotransaminase (AST) and Bilirubin total) with particular relevance to patients with HCV.|baseline (day 1, after first dose of randomised treatment) up to 7 days after the last intake of study|FAS||percentage of participants|||Number
839958|NCT01330316|Secondary|Occurrence of Drug-related AEs as Assessed by the Investigator|This outcome measure will be presented as the percentage of subjects with any drug-related AEs as assessed by the investigator. Percentages are calculated using total number of subjects per treatment cohort as the denominator.|from first intake of study medication until 30 days after discontinuing faldaprevir, up to a maximum of 213 days|FAS||percentage of participants|||Number
839959|NCT01330316|Secondary|Occurrence of Serious Adverse Events (SAEs)|This outcome measure will be presented as the percentage of subjects with any serious adverse event (SAE). Percentages are calculated using total number of subjects per treatment cohort as the denominator.|from first intake of study medication until 30 days after discontinuing faldaprevir, up to a maximum of 213 days|FAS||percentage of participants|||Number
839960|NCT01330316|Secondary|Occurrence of Adverse Events Leading to Treatment Discontinuation|This outcome measure will be presented as the percentage of subjects with adverse events leading to discontinuation of Faldaprevir and all study medication. Percentages are calculated using total number of subjects per treatment cohort as the denominator.|from first intake of study medication until 30 days after discontinuing faldaprevir, up to a maximum of 213 days|FAS||percentage of participants|||Number
839961|NCT01330316|Secondary|Occurrence of Adverse Events (Overall and by DAIDS Grade)|"This outcome measure will be presented as the percentage of subjects with any adverse event (AE).
Percentages are calculated using total number of subjects per treatment cohort as the denominator.
The intensity of all AEs was evaluated according to the DAIDS (Division of Acquired Immunodeficiency Syndrome) grading scale with AEs of mild, moderate, or severe intensity receiving Grades 1, 2, or 3, respectively. Adverse events judged potentially life threatening received a Grade 4 assessment."|from first intake of study medication until 30 days after discontinuing faldaprevir, up to a maximum of 213 days|FAS||percentage of participants|||Number
839962|NCT01330316|Secondary|Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at 12 Weeks Post-treatment.|This will be presented as the number of patients in/not in normal range from baseline to 12 weeks post treatment. SVR12 is sustained virological response 12 weeks post-treatment.|Week 48 for relapsers with ETS; Week 48 for relapsers without ETS, and non-relapsers|FAS||participants|||Number
839963|NCT01330316|Secondary|Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EoT)|This will be presented as the number of patients in/not in normal range from baseline to EoT. SVR12 is sustained virological response 12 weeks post-treatment.|Week 24 for relapsers with ETS; Week 48 for relapsers without ETS, and non-relapsers.|FAS||participants|||Number
839964|NCT01330316|Secondary|Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at 12 Weeks Post-treatment.|This will be presented as the number of patients in/not in normal range from baseline to 12 weeks post treatment. SVR12 is sustained virological response 12 weeks post-treatment.|48 weeks for relapsers with ETS; 60 weeks for non-relapsers and relapsers without ETS|FAS||participants|||Number
839965|NCT01330316|Secondary|Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EoT)|This will be presented as the number of patients in/not in normal range from baseline EoT. SVR12 is sustained virological response 12 weeks post-treatment.|Week 24 for relapsers with ETS; Week 48 for relapsers without ETS, and non-relapsers|FAS||participants|||Number
839966|NCT01330316|Secondary|Early Treatment Success (ETS)|ETS, defined as a plasma HCV RNA level <25 IU/mL (detected or undetected) at week 4 and HCV RNA <25 IU/mL (undetected) at week 8.|week 4 and week 8|FAS||percentage of participants|||Number
839967|NCT01330316|Secondary|Sustained Virological Response After 24 Weeks of Treatment Discontinuation (SVR24)|Sustained virologic response 24 weeks, defined as a plasma HCV RNA level < 25 IU/mL (undetected) 24 weeks after the originally planned treatment duration.|24 weeks post treatment, up to 72 weeks|FAS||percentage of participants||95% Confidence Interval|Number
839968|NCT01330316|Primary|Sustained Virological Response (SVR): Plasma HCV RNA Level < 25 IU/mL|The primary endpoint was SVR12, defined as a plasma Hepatitis C virus (HCV) Ribonucleic acid (RNA) level <25 IU/mL (undetected) 12 weeks after the originally planned treatment duration.|12 weeks post treatment, up to 60 weeks|FAS||percentage of participants||95% Confidence Interval|Number
839969|NCT01330355|Secondary|Microbial Outcome|"Microbial outcome for the following groups of accepted ocular bacterial species that were present at or above threshold at baseline:
over all bacterial species
over all and individual gram-positive bacterial species
over all and individual gram-negative bacterial species"|Visit 3 (Day 3) and Visit 5 (Day 8+1)|The analysis population only includes those for whom the outcome was measured within the specified time frame. A subject may have tested positive for multiple bacterial species (up to 5 species).||events|||Number
839970|NCT01330355|Secondary|Microbial Eradication|Eradication defined as the absence of all accepted ocular bacterial species (as measured on the ordinal scale) that were present at or above threshold at baseline|Visit 5 (Day 8+1)|The analysis population only includes those for whom the outcome was measured within the specified time frame.||participants|||Number
839971|NCT01330355|Secondary|Clinical Resolution|Clinical resolution defined as the absence of both conjunctival discharge and conjunctival hyperemia.|Visit 3 (Day 3)|The analysis population only includes those for whom the outcome was measured within the specified time frame.||participants|||Number
841684|NCT01347580|Secondary|Definite Stent Thrombosis|Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. It is an adjudicated endpoint|during 30 days of treatment|mITT||patients|||Number
839977|NCT01330381|Secondary|Severity of Constipation Over the Past 2 Weeks for the Final On Treatment Assessment in the Double-Blind Treatment Period||2 weeks|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome.||percentage of subjects|||Number
839978|NCT01330381|Secondary|Change From Baseline in the Number of SBM Per Week Over the 8 Week Double Blind Treatment Period||Baseline and over the 8 week double blind treatment period|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome.||SBM/week||Standard Deviation|Mean
839979|NCT01330381|Secondary|Number of SBM Per Week in the Double-Blind Treatment Period||Over the 8 week double blind treatment period|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome.||SBM/week||Standard Deviation|Mean
839980|NCT01330381|Secondary|Time to First SBM in the Double-Blind Treatment Period|After intake of the trial medication on Day 1.|Day 1 onwards|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product.||hours||95% Confidence Interval|Median
839981|NCT01330381|Secondary|Number of Rescue Medications Taken in the Double-Blind Treatment Period||Over the 8 week double blind treatment period|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome.||rescue medications/week||Standard Deviation|Mean
839982|NCT01330381|Secondary|Frequency of Toilet Training in the Double-Blind Treatment Period|Only for subjects after acquisition of toileting skills.|Over the 8 week double blind treatment period|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome.||toilet trainings/week||Standard Deviation|Mean
839983|NCT01330381|Secondary|Abdominal Pain Score in Double-Blind Treatment Period|Pain was rated on a 6-point scale (0=no hurt, 1=hurts little bit, 2=hurts little more, 3=hurts even more, 4=hurts whole lot, 5=hurts worst) in subjects of 3 years and older. Lower scores represent less pain.|Over the 8 week double blind treatment period|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome.||units on a scale||Standard Deviation|Mean
839984|NCT01330381|Secondary|Large Diameter Stools in the Double-Blind Treatment Period|Large diameter stools make defecation more difficult. Small diameter stools are better.|Over the 8 week double blind treatment period|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome.||large diameter stools/week||Standard Deviation|Mean
839985|NCT01330381|Secondary|Stool Consistency Per SBM Score in Children With Diapers in the Double-Blind Treatment Period|Measured on a 4-point scale where 1 is constipation, 2-3 is ideal, and 4 is diarrhea.|Over the 8 week double blind treatment period|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome.||units on a scale||Standard Deviation|Mean
839986|NCT01330381|Secondary|Stool Consistency Per SBM Score in Children Without Diapers in the Double-Blind Treatment Period|Measured using the 7-point Bristol scale where 1-2 indicate constipation, 3-4 are ideal stools, and 5-7 tending toward diarrhea.|Over the 8 week double blind treatment period|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome.||units on a scale||Standard Deviation|Mean
839987|NCT01330381|Secondary|Painful Bowel Movements Score in the Double-Blind Treatment Period|Pain was rated on a 6-point scale (0=no hurt, 1=hurts little bit, 2=hurts little more, 3=hurts even more, 4=hurts whole lot, 5=hurts worst) in subjects of 3 years and older. Lower scores represent less pain.|Over the 8 week double blind treatment period|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome.||units on a scale||Standard Deviation|Mean
839988|NCT01330381|Secondary|Number of Retentive Posturing or Excessive Volitional Stool Retention in the Double-Blind Treatment Period|Purposefully avoiding defecation.|Over the 8 week double blind treatment period|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome.||retentions/week||Standard Deviation|Mean
839989|NCT01330381|Secondary|Percent of Subjects With Fecal Incontinence Episodes of 1 or Less Per 2 Weeks in the Last Four Weeks of the Double-Blind Treatment Period|Fecal incontinence is a lack of control over defecation, leading to involuntary loss of bowel contents (only for subjects after acquisition of toileting skills).|Last 4 weeks of double-blind treatment period|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome.||percentage of subjects|||Number
839990|NCT01330381|Secondary|Percent of Subjects With Bowel Frequency of 3 or More Spontaneous Bowel Movements (SBM) Per Week in the Last Four Weeks of the Double-Blind Treatment Period|Spontaneous Bowel Movements defined as a bowel movement that is not preceded within a period of 24 hours by the intake of a laxative agent or by the use of an enema.|Last 4 weeks of double-blind treatment period|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product.||percentage of subjects|||Number
839991|NCT01330381|Primary|Percent of Responders in the Last Four Weeks of the Double-Blind Treatment Period|Responders are defined as subjects with an average spontaneous defecation frequency is ≥3 times per week AND the average number of fecal incontinence episodes per 2 weeks is ≤ 1 episode (only for subjects after acquisition of toileting skills).|Last 4 weeks of double-blind treatment period|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product.||percentage of subjects|||Number
839992|NCT01330394|Secondary|Effort to Control the Urge for Use Alcohol|Obsessive Compulsive Drinking Scale will be applied before and after ERP procedures|one year and a half||||||
839993|NCT01330394|Secondary|Quality of Life|Quality of life scale will be applied at the end of the protocol|one year and a half||||||
841685|NCT01347580|Secondary|2nd Composite Clinical Endpoint|Death/MI/urgent revascularization. Adjudicated events except death|within 30 days of study|mITT||patients|||Number
839995|NCT01330394|Secondary|Event-related Potentials|Event-related potential (ERPs) was recorded under the presentation of 120 sounds [60 of 3 types related to the use of alcoholic beverages (open a can of beer, fill a glass of beer, opening and fall of the lid of a bottle of beer), and 3 types of 60 neutral sounds (open a door, typing a keyboard, shower water)] lasted for 384 s for each period before and after transcranial Direct Current Stimulation|one year and a half||||||
839996|NCT01330394|Primary|Use of Alcohol|Relapse to the use of alcohol to a usual pattern observed before treatment (for example, if a patient was used to have 10 drinks/day before treatment and start to have about this amount of drinks/day with similar behavior seen before treatment, it would be considered a relapse).|6 months after treatment|||participants|||Number
839997|NCT01330420|Secondary|The Health Promoting Lifestyle Profile II (HPLP-II)|"The Health Promoting Lifestyle Profile II (HPLP-II) was used to assess health promoting behaviors. Based on the Health Promoting Model (Pender, 1982) this 52-item instrument measures self-initiated health behaviors that serve to maintain or enhance the level of self-actualization and wellness. Included are subscales for physical activity, spiritual growth, health responsibility, interpersonal relations, nutrition, and stress management. It is self-administered and uses a 4-point response format. Both English and Spanish versions are available.
A score for overall health-promoting lifestyle is obtained by calculating a mean of the individual's responses to all 52 items; six subscale scores are obtained similarly by calculating a mean of the responses to subscale items. Scores range from 1 = Never to 4 = Routinely, with a higher score corresponding to a more health promoting lifestyle."|comparison pre program initiation and post program completion time points (6 weeks)|24 patients met completer status, defined as patients who attended all or part of the six sessions. Not all 24 patients had complete pre-/post-intervention questionnaires sets. Therefore, patients may have missed some of the questionnaires, either pre- or post-intervention, and thus the number of patients analyzed maybe less than 24.||units on a scale||Standard Deviation|Mean
839998|NCT01330420|Primary|Satisfaction With Care (PSQ-18)|Patient Satisfaction Questionnaire Short Form (PSQ-18) takes approximately 3-4 minutes to complete, containing 18 items examining seven dimensions of satisfaction with medical care: general satisfaction (2 questions, Mean =3.58, SD =0.94), technical quality (3 questions, Mean = 3.68, SD = 0.76), interpersonal manner (2 questions, Mean = 4.09, SD = 0.69), communication (2 questions, Mean = 3.74, SD = 0.87), financial aspects (2 questions, Mean = 3.78, SD = 0.94), time spent with doctor (2 questions, Mean = 3.59, SD = 0.94), and accessibility and convenience (4 questions, Mean = 3.76, SD = 0.74). Responses to each item are given on a 5-point scale ranging from 1 - strongly agree to 5 - strong disagree, therefore higher scores correspond to less satisfaction. PSQ-18 subscale scores are substantially correlated with their full-scale counterparts and possess generally adequate internal consistency reliability.|comparison pre program initiation and post program completion time points (6 weeks)|24 patients met completer status, defined as patients who attended all or part of the six sessions. Not all 24 patients had complete pre-/post-intervention questionnaires sets. Therefore, patients may have missed some of the questionnaires, either pre- or post-intervention, and thus the number of patients analyzed maybe less than 24.||units on a scale||Standard Deviation|Mean
839999|NCT01330420|Primary|Quality of Life (QOL-5)|The QOL-5 is a short, global, and generic quality of life (QoL) questionnaire for clinical databases. The QOL-5 item tool is used to compare various population groups using generic factors common to people everywhere irrespective of age, sex, culture, and state of health. Scores on the QOL-5 ranges from 0 = lowest quality to 100 = highest quality.|comparison pre program initiation and post program completion time points (6 weeks)|||units on a scale||Standard Deviation|Mean
840000|NCT01330420|Primary|Health Status (SF-12)|The SF-12 was used to assess health status. It is the shortened version of the well-validated SF-36, directed at monitoring overall physical and mental health outcomes. It is available in both English and Spanish. Scoring algorithms involve weighted-item responses, all 8 scales to use the same standardization for easy comparison. All scores range from 0–100 where higher scores indicated better QOL. The mean = 50 and the SD = 10.|comparison pre program initiation and post program completion time points (6 weeks)|24 patients met completer status, defined as patients who attended all or part of the six sessions. Not all 24 patients had complete pre-/post-intervention questionnaires sets. Therefore, patients may have missed some of the questionnaires, either pre- or post-intervention, and thus the number of patients analyzed maybe less than 24.||units on a scale||Standard Deviation|Mean
840001|NCT01330420|Primary|Depression Severity (CEDS-10)|The Center for Epidemiologic Studies Depression Scale (CES-D 10) was used to assess depression severity pre-and post-intervention. This is the shorter 10-item, modified version of the 20-item CES-D. The total score is the sum of the 10 item weights, with the lowest possible score being 0 and the highest possible score being 30, and a higher score indicating more depressive symptoms. Developed from other well-validated depression scales, this instrument measures the experience of depressive symptoms over the past week. This instrument is shown to be better than the CES-D 20 in combining data from different ethnic and cultural groups, and is available in both English and Spanish. This scale has been reported to have good internal consistency and validity.|comparison pre program initiation and post program completion time points (6 weeks)|24 patients met completer status, defined as patients who attended all or part of the six sessions. Not all 24 patients had complete pre-/post-intervention questionnaires sets. Therefore, patients may have missed some of the questionnaires, either pre- or post-intervention, and thus the number of patients analyzed maybe less than 24.||units on a scale||Standard Deviation|Mean
840002|NCT01330433|Secondary|Hospital Stay|Number of days post surgery.|Length of stay after second surgery up to 1 month|The difference in the number of participants analyzed and the total number of participants is due to feeding issues unrelated to the surgery or the device that required the subject to remain hospitalized longer than anticipated.||days||Standard Deviation|Mean
840003|NCT01330433|Primary|Adhesion Burden|Skin to bypass time as an indicator of adhesion burden.|Time it takes for patient to be put on bypass (an average time between 0 and 120 minutes)|||minutes||Standard Deviation|Mean
840004|NCT01330433|Primary|Post-operative Bleeding|Post-operative bleeding through surgical site drainage output.|Post-operative bleeding data will be collected on average, during the first 36 hours after the surgery|The difference in the number of participants analyzed and the total number of participants is due to the information not being properly collected at the time of the surgery. Because there was a lack of confidence in the data, it was discarded.||cm^3||Standard Deviation|Mean
840005|NCT01330433|Primary|Severity of Adhesions at the Right Lateral Site|Severity of adhesions at five predefined sites (retrosternal, diaphragmatic region, right lateral, left lateral, arterial base). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites).|Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery|||percentage of participants|||Number
840006|NCT01330433|Primary|Severity of Adhesions at the Left Lateral Site|Severity of adhesions at five predefined sites (retrosternal, diaphragmatic region, right lateral, left lateral, arterial base). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites).|Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery|||percentage of participants|||Number
840007|NCT01330433|Primary|Severity of Adhesions at the Diaphragm Site|Severity of adhesions at five predefined sites (retrosternal, diaphragmatic region, right lateral, left lateral, arterial base). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites).|Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery|||percentage of participants|||Number
840008|NCT01330433|Primary|Severity of Adhesions at the Arterial Base Site.|Severity of adhesions at five predefined sites (retrosternal, diaphragmatic region, right lateral, left lateral, arterial base). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites).|Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery|||percentage of participants|||Number
840009|NCT01330433|Primary|Severity of Adhesions at the Retrosternal Site|Severity of adhesions at seven predefined sites (pericardial or retrosternal, inferior or diaphragmatic region, right lateral or arterial region, region around great vessels). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites).|Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery|||percentage of participants|||Number
840010|NCT01330628|Primary|Freedom From Major Adverse Events (MAE)|Number of participants free from Major Adverse Events (MAE) at 30 days. MAE are defined all cause death, major amputation in the target limb, or target lesion revascularization (TLR) from procedure to 30 days (±7 days).|30 days|The number of participants analyzed for this endpoint does not match with the Participant Flow 30 Day Follow-up population. If a subject did not complete a 30 Day Follow-up due to missing the visit or lost to follow-up, but had an MAE prior to this time point, they would still be included in this outcome analysis.||# of participants free from MAE|||Number
840011|NCT01330628|Primary|Freedom From Target Lesion Revascularization (TLR)|Number of participants free from Target Lesion Revascularization (TLR) through 6 months follow-up.|6 months|The number of participants analyzed for this endpoint does not match with the Participant Flow 6 Month Follow-up population. A subject may not complete a 6 Month Follow-up due to missing the visit, being lost to follow-up, etc., but if they had a TLR prior to this time point, they would still be included in this outcome analysis.||# of participants free from TLR|||Number
840012|NCT01330914|Secondary|Bone Structure|Trabecular and cortical bone microstructure by HR-pQCT|pre-operatively and 6 and 12 months post-operatively||||||
840013|NCT01330914|Secondary|Bone Mineral Density (BMD, Areal and Volumetric)|Areal BMD at the spine, proximal femur, and forearm by dual-energy X-ray absorptiometry (DXA); volumetric BMD at the spine and hip by quantitative computed tomography (QCT); volumetric BMD at the ultradistal radius and ultradistal tibia by high-resolution peripheral QCT (HR-pQCT)|pre-operatively and 6 and 12 months post-operatively||||||
840014|NCT01330914|Primary|Change in Intestinal Calcium Absorption|"Change in fractional calcium absorption, determined by dual stable isotope method.
Fractional calcium absorption is the fraction of ingested calcium that is absorbed, which is expressed here as the percentage of ingested calcium that is absorbed. The 6-month change is the mean difference in percentage absorption between time points. For example, if fractional calcium absorption were to decrease from 30% preoperatively to 25% at the 6-month postoperative time point, the change in fractional calcium absorption would be -5%."|6 months|Participants from the cohort who underwent assessment of fractional calcium absorption preoperatively and 6 months postoperatively||% of ingested calcium that is absorbed||Standard Deviation|Mean
840015|NCT01331005|Secondary|Change in Level of Diabetic Retinopathy on Stereoscopic Fundus Photographs|95% CI will be obtained in each treatment group and compared between treatment groups at 1 year. For eyes that have received treatment for DME before 1 year, visual acuity and OCT measurements obtained at time of failure will be used instead of measurements at 1 year.|Baseline to 12 months||||||
840016|NCT01331005|Secondary|Change in Number of Thickened Subfields on OCT|95% CI will be obtained in each treatment group and compared between treatment groups at 1 year. For eyes that have received treatment for DME before 1 year, visual acuity and OCT measurements obtained at time of failure will be used instead of measurements at 1 year.|Baseline to 12 months||||||
840017|NCT01331005|Secondary|Change in OCT Central Subfield Thickness|95% CI will be obtained in each treatment group and compared between treatment groups at 1 year. For eyes that have received treatment for DME before 1 year, visual acuity and OCT measurements obtained at time of failure will be used instead of measurements at 1 year.|baseline to 12 months||||||
841686|NCT01347580|Secondary|1st Composite Clinical Endpoint|death/MI/stroke/urgent revascularization/stent thrombosis. Adjudicated events except death|during the 30 days of treatment|mITT||patients|||Number
840018|NCT01331005|Secondary|Mean Change in Visual Acuity|The 95% CI will be obtained in each treatment group and compared between treatment groups at 1 year. For eyes that have received treatment for diabetic macular edema(DME) before 1 year, visual acuity and optical coherence tomography (OCT) measurements obtained at time of failure will be used instead of measurements at 1 year.|baseline to 12 months||||||
840019|NCT01331005|Secondary|Irritation||Baseline to 12 months||||||
840020|NCT01331005|Secondary|Corneal Melting||Baseline to 12 months||||||
840021|NCT01331005|Secondary|Corneal Ulceration||Baseline to 12 months||||||
840022|NCT01331005|Primary|Mean Change in Optical Coherence Tomography Measure Retinal Volume, mm3||From Baseline to 12 months|||mm3||95% Confidence Interval|Mean
840023|NCT01331109|Other Pre-specified|Number of Patients Who Experienced Any Suicidal Behavior as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS)|"The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) is a validated, self-rated version of the C-SSRS designed to uniquely assess both suicidal behavior and ideation. Suicidal behaviors as defined by the eC-SSRS are:
Preparatory acts or behavior
Aborted attempt
Interrupted attempt
Actual attempt
Completed suicide attempt"|Baseline (Visit 1) to Week 53 (Visit 9)|57 patients who took at least 1 dose of open-label milnacipran were included in the safety population.||participants|||Number
840024|NCT01331109|Other Pre-specified|Number of Patients Who Experienced Level 1 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS).|"The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) is a validated, self-rated version of the C-SSRS designed to uniquely assess both suicidal behavior and ideation. Suicidal ideation is assessed at 5 distinct levels of increasing severity:
Level 1: Wish to be Dead
Level 2: Non-Specific Active Suicidal Thoughts
Level 3: Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act
Level 4: Active Suicidal Ideation with Some Intent to Act, without Specific Plan
Level 5: Active Suicidal Ideation with Specific Plan and Intent"|Baseline (Visit 1) to Week 53 (Visit 9)|57 patients who took at least 1 dose of open-label milnacipran were included in the safety population.||participants|||Number
840025|NCT01331109|Other Pre-specified|Number of Patients Who Experienced Level 2 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS).|"The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) is a validated, self-rated version of the C-SSRS designed to uniquely assess both suicidal behavior and ideation. Suicidal ideation is assessed at 5 distinct levels of increasing severity:
Level 1: Wish to be Dead
Level 2: Non-Specific Active Suicidal Thoughts
Level 3: Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act
Level 4: Active Suicidal Ideation with Some Intent to Act, without Specific Plan
Level 5: Active Suicidal Ideation with Specific Plan and Intent"|Baseline (Visit 1) to Week 53 (Visit 9)|57 patients who took at least 1 dose of open-label milnacipran were included in the safety population.||participants|||Number
840026|NCT01331109|Other Pre-specified|Number of Patients Who Experienced Level 3 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS).|"The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) is a validated, self-rated version of the C-SSRS designed to uniquely assess both suicidal behavior and ideation. Suicidal ideation is assessed at 5 distinct levels of increasing severity:
Level 1: Wish to be Dead
Level 2: Non-Specific Active Suicidal Thoughts
Level 3: Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act
Level 4: Active Suicidal Ideation with Some Intent to Act, without Specific Plan
Level 5: Active Suicidal Ideation with Specific Plan and Intent"|Baseline (Visit 1) to Week 53 (Visit 9)|57 patients who took at least 1 dose of open-label milnacipran were included in the safety population.||participants|||Number
840027|NCT01331109|Primary|Adverse Events|Number of Patients who experience one or more treatment emergent adverse event (TEAE)|Baseline (Visit 1) to Week 53 (Visit 9)|57 patients who took at least 1 dose of open-label milnacipran were included in the safety population.||participants|||Number
840028|NCT01331109|Other Pre-specified|Number of Patients Who Experienced Level 4 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS).|"The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) is a validated, self-rated version of the C-SSRS designed to uniquely assess both suicidal behavior and ideation. Suicidal ideation is assessed at 5 distinct levels of increasing severity:
Level 1: Wish to be Dead
Level 2: Non-Specific Active Suicidal Thoughts
Level 3: Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act
Level 4: Active Suicidal Ideation with Some Intent to Act, without Specific Plan
Level 5: Active Suicidal Ideation with Specific Plan and Intent"|Baseline (Visit 1) to Week 53 (Visit 9)|57 patients who took at least 1 dose of open-label milnacipran were included in the safety population.||participants|||Number
840029|NCT01331109|Other Pre-specified|Number of Patients Who Experienced Level 5 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS).|"The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) is a validated, self-rated version of the C-SSRS designed to uniquely assess both suicidal behavior and ideation. Suicidal ideation is assessed at 5 distinct levels of increasing severity:
Level 1: Wish to be Dead
Level 2: Non-Specific Active Suicidal Thoughts
Level 3: Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act
Level 4: Active Suicidal Ideation with Some Intent to Act, without Specific Plan
Level 5: Active Suicidal Ideation with Specific Plan and Intent"|Baseline (Visit 1) to Week 53 (Visit 9)|57 patients who took at least 1 dose of open-label milnacipran were included in the safety population.||participants|||Number
840069|NCT01325493|Secondary|Sedation Score|"Sedation scores 0 = completely awake
= sleepy but responds appropriately
= somnolent but arouses to light stimuli
= asleep but responsive to deeper physical stimuli
= asleep and not responsive to any stimuli Values are for each 24 hour time period and displayed as hours post surgery."|24, 48, 72, 96 hours post operatively|||Sedation Score||Standard Deviation|Mean
840032|NCT01331213|Secondary|Post-treatment Sensory Threshold for Gas|The sensory threshold for first perception of gas was measured by stepwise inflation of the balloon in increments of 4 mm Hg at 60 second intervals. The balloon was placed in the mid-descending or junction of the sigmoid and descending colon. During this assessment participants were asked to report when they had the first perception of gas. The investigator recorded the threshold pressure at which the participants reported this sensation.|Approximately 60 minutes after drug administration|||mm Hg||Standard Deviation|Mean
840033|NCT01331213|Secondary|Colonic Motility Index|The postprandial motility index (MI)=log_e[number of contractions * sum of amplitudes) + 1] A normal fasting average motility index (MI) would be about 12. An increase in MI means an increase in the phasic contractions (in contrast to tone) which is measured as a change in volume of the barostatically-controlled balloon. (Therefore, an increase in MI means that the meal is moving more quickly through the colon.)|Approximately 1 hour after meal|||log mm Hg||Standard Deviation|Mean
840034|NCT01331213|Secondary|Fasting Colonic Tone|Colonic tone is a measurement of the volume of the colon. Colonic tone was assessed by noting the changes in the balloon volume in the presence of a constant operating pressure in the balloon (in the barostat-manometric assembly placed in the colon.)|Approximately 60 minutes after drug administration|||mL||Standard Deviation|Mean
840035|NCT01331213|Primary|Overall Sensory Ratings in Response to 16, 24, 30 and 36 mm Hg Distensions.|The mm Hg distensions refer to the barostat balloon, which was placed in the mid-descending or junction of the sigmoid and descending colon. Pain sensation was measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes. For the pain VAS, 0 means no pain and 100 mm means extreme pain. The investigator measures the mark made by the participant in mm and records this for the value of pain.|Approximately 60 minutes after drug administration|||mm||Standard Deviation|Mean
840036|NCT01331213|Primary|Sensory Threshold for Pain|The sensory threshold for first perception of pain was measured by stepwise inflation of the balloon in increments of 4 mm Hg at 60 second intervals. The balloon was placed in the mid-descending or junction of the sigmoid and descending colon. During this assessment participants were asked to report when they had the first perception of pain. The investigator recorded the threshold pressure at which the participants reported this sensation.|approximately 60 minutes after drug administration|||mm Hg||Standard Deviation|Mean
840037|NCT01331213|Primary|Postprandial Colonic Tone [Reported as the Symmetric Percent [Change} in Baseline Colonic Barostat Balloon Volume|The symmetric percent reduction in baseline colonic barostat balloon volume during the first 30 minutes postprandially (PP) corrected for the preprandial (30 min) tone, (symmetric percent change= 100*log_e[fasting/PP]). A positive symmetric percent change reflects a decrease in barostat balloon volume indicating a reduction in colonic tone. (The balloon was placed in the mid-descending or junction of the sigmoid and descending colon.)|The first 30 minutes postprandially, and preprandial (30 minutes)|||Symmetric percentage change||Standard Deviation|Mean
840038|NCT01331213|Primary|Colonic Compliance|"Colonic compliance is a measure of the stiffness of the colon, that is, what pressure was needed to reach half the maximum volume of the colon. After the barostat balloon catheter was inserted in the mid-descending or junction of the sigmoid and descending colon, the balloon was inflated. After an initial conditioning distension to 20 mm Hg, colonic compliance was measured by step-wise inflation with increments of 4 mm Hg. Colonic compliance was analyzed by a validated linear interpolation method. The pressure at half maximum volume serves as a summary of colonic compliance."|baseline (1 hour before drug administration), post-treatment (1 hour after drug administration)|||mm Hg||Standard Deviation|Mean
840039|NCT01331291|Secondary|Anti-tumor Response|Assess anti-tumor response in patients in Arm B using MacDonald criteria. There are four possible responses: complete response, partial response, stable disease, or progressive disease. Criteria are based on measurements of tumor dimension as visualized with a contrast-enhanced MRI.|2 years|Only Arm B participants were evaluable for this outcome measure||participants|||Number
840040|NCT01331291|Secondary|Safety Profile|Overall safety profile will be characterized by type, frequency, severity (as graded by NCI CTCAE), timing and relationship of study therapy of adverse events and laboratory abnormalities. Safety and tolerability will be measured by the proportion of patients who experience Grade 3 or higher Adverse Events that are possibly, probably or definitely related to bosutinib and the number of same Adverse Events per patient. Adverse Events will be summarized by treatment for each arm by the frequency of patients experiencing treatment emergent adverse events.|2 years|||participants|||Number
840041|NCT01331291|Secondary|Intratumoral Concentration|Assess the intratumoral concentration of bosutinib in recurrent glioblastoma patients who are candidates for surgical re-resection (ARM A).|2 years|Participants in Arm B were never eligible for this outcome measure. Because only two participants were enrolled to Arm A, this analysis was not done as there were not sufficient tumor samples to generate meaningful results.|||||
840042|NCT01331291|Primary|Progression-Free Survival|Assess progression-free survival at six months in patients with recurrent glioblastoma at first or second recurrence who are treated with continuous daily dosing of bosutinib (Arm B). Progression-free survival is measured from initiation of study treatment to date of progression.|2 years|This outcome was only applicable to participants enrolled on Arm B.||weeks||95% Confidence Interval|Median
840043|NCT01331304|Primary|Necessary Clinical Adjustments|Necessary Clinical Adjustment (NCA): The Medication Recommendation Tracking Form was developed and successfully implemented in a previous study to capture recommended medication changes at each study visit 17. Clinicians record dosage changes, missed doses, new medications added or discontinued, and specify the reason for each change. Any change in psychotropic medications, or medications used to treat side effects, is coded along with the reason for the change. NCAs include those changes made for lack of effectiveness or intolerance, but not changes for planned dose titrations.|6 Months|||Mean NCAs per month||Standard Deviation|Mean
840044|NCT01331304|Secondary|Longitudinal Interval Follow up Evaluation Range of Impaired Functioning Tool (LIFE-RIFT)|The LIFE-RIFT asses the extent to which psychopathology has impacted current functioning in work, household chores, interpersonal relationships with partner, family, and friends, recreational activities, and life, satisfaction, leisure activities and social relationships.|6 months||||||
840045|NCT01331304|Secondary|Risk of Cardiovascular Disease - Framingham Risk Score|The Framingham risk score captures the classic risk factors for cardiovascular disease, including age, sex, systolic blood pressure, total and high density lipoprotein cholesterol, diabetes mellitus, and smoking. The Framingham risk score is used as a simple predictive tool to determine 10-year (short term) risk for developing cardiovascular disease (CHD).|6 months||||||
840046|NCT01331304|Primary|Clinical Global Impression-Efficacy Index (CGI-EI)|The CGI-EI integrates benefits and harms and yields a score that can be compared across interventions. It is made up of 2 subscales: therapeutic effects and side effects. Each rating is on a scale from 1 to 4. To combine these two subscales into the CGI-EI we report as our primary outcome, we subtracted the side effects subscale from the therapeutic effects subscale. Thus, the CGI-EI we report ranges the integers from -3 to +3 (i.e. possible scores are -3,-2,-1,0,1,2,3). A score of -3 is the most burdensome side effect score (4) and the least therapeutic effect score (1) and a score of +3 is the least burdensome side effect score (1) and the highest therapeutic effect score (4). Higher CGI-EI signifies better outcome (minimal side effects, maximal therapeutic effect). Lower CGI-EI signifies worse outcome (maximal side effects, minimal therapeutic effect).To compute CGI-EI score, we subtract the side effect score from the therapeutic effect score.|Average 6 month score minus Average baseline score|||Units on the scale||95% Confidence Interval|Mean
840047|NCT01331681|Secondary|Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Distance Activities Subscale at Week 52 - LOCF|The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales that are all scored from 0-100. Distance activities are defined as reading street signs or names on stores, and going down stairs, steps, or curbs.|Baseline up to Week 52|Full-Analysis Set with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
840048|NCT01331681|Secondary|Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Near Activities Subscale at Week 52 - LOCF|The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales that are all scored from 0-100. Near activities are defined as reading ordinary print in newspapers, performing work or hobbies requiring near vision, or finding something on a crowded shelf.|Baseline up to Week 52|Full-Analysis Set with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
840049|NCT01331681|Secondary|Change From Baseline in Central Retinal Thickness (CRT) at Week 52 as Assessed on Optical Coherence Tomography (OCT) - LOCF||Baseline up to Week 52|Full-Analysis Set with assessment for this outcome measure.||micrometer||Standard Deviation|Mean
840050|NCT01331681|Secondary|Percentage of Participants With a ≥2-step Improvement From Baseline in the ETDRS DRSS (Diabetic Retinopathy Severity Score) as Assessed by FP (Fundus Photography) at Week 52 - LOCF|Baseline ETDRS DRSS: None (level 10); Mild to moderate nonproliferative DR (levels 14, 15, 20, 35, and 43); Moderately severe/severe nonproliferative DR (levels 47 and 53); Mild/moderate/high-risk/advanced proliferative DR (levels 61, 65, 71,75, 81, and 85)|Baseline up to Week 52|Full-Analysis Set with assessment for this outcome measure.||Percentage of participants|||Number
840051|NCT01331681|Secondary|Percentage of Participants Who Gained at Least 15 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF|Visual function of the study eye was assessed using the ETDRS protocol. A higher score represents better functioning.|Baseline up to Week 52|FAS.||Percentage of participants|||Number
840052|NCT01331681|Secondary|Percentage of Participants Who Gained at Least 10 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF|Visual function of the study eye was assessed using the ETDRS protocol. A higher score represents better functioning.|Baseline up to Week 52|FAS.||Percentage of participants|||Number
840053|NCT01331681|Primary|Change From Baseline in BCVA (Best Corrected Visual Acuity) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 52 - Last Observation Carried Forward (LOCF)|Visual function of the study eye was assessed using the ETDRS protocol. A higher score represents better functioning.|Baseline up to Week 52|Full analysis set (FAS) included all randomized participants who received any study treatment, had a baseline measurement of BCVA, and had at least 1 post-baseline assessment of BCVA.||Letters correctly read||Standard Deviation|Mean
840054|NCT01331694|Secondary|Average Annual Adjusted Post-Index COPD-Related Costs|Medical costs are associated with COPD-related medical care (claims submitted with a primary International Classification of Diseases, 9th Revision, Clinical Modification diagnosis of COPD) and pharmaceutical care (treatment arm medications, oral corticosteroids, oral antibiotics, short-acting beta-agonists, long-acting beta-agonists [LABA], inhaled corticosteroids [ICS], ICS/LABA combinations, etc.. Means are adjusted for age, sex, geographic region, pre-initial treatment comorbidities, and COPD-related utilization. Total costs are the sum of medical care and pharmacy costs.|Incurred over the 12 month period after initial treatment arm prescription|All participants from a large database comprised of information from enrollment files and facility, professional service, and outpatient pharmacy claims from a variety of private healthcare benefit plans covering over 40 million patients enrolled in over 70 health plans (providing data continuously) across the United States||United States dollars||Standard Deviation|Mean
840055|NCT01331694|Primary|Time to First Chronic Obstructive Pulmonary Disease (COPD) Event|The first COPD event occurring after 30 days from initial treatment arm prescription was measured. Four categories of COPD events were analyzed; either a hospitalization or emergency department visit; an emergency department visit; an outpatient visit followed by an oral corticosteroid prescription claim within 10 days; an outpatient visit followed by an oral antibiotic prescription claim within 10 days.|Anytime from 30 days to 12 months after initial treatment arm prescription|All participants from a large database comprised of information from enrollment files and facility, professional service, and outpatient pharmacy claims from a variety of private healthcare benefit plans covering over 40 million patients enrolled in over 70 health plans (providing data continuously) across the United States.||days||Standard Error|Mean
840056|NCT01325428|Secondary|Progression Free Survival Over the Whole Sudy.|PD was evaluated according to the RECIST version 1.1. Number of days from the start of monotherapy to the date of second PD.|From first drug administration until end of study, up to 700 days.|"TRT A Treated Set (Part A): All patients who were documented to have taken at least one dose of Afatinib in Part A.
TRT B Treated set (Part B): All patients who received at least one dose each of Afatinib and Vinorelbine in Part B."||Days||95% Confidence Interval|Median
840070|NCT01325493|Primary|Morphine Equivalent Consumption (mg/kg)|Morphine consumption (mg/kg) was measured over time in the Ketamine group and compared to the Control (saline) group. Values are for each 24 hour time period and displayed as hours post surgery.|at 24, 48, 72, 96 hours post operatively|||mg/kg||Standard Deviation|Mean
840057|NCT01325428|Secondary|Part B: Progression Free Survival.|PD was evaluated according to the RECIST version 1.1. For patients with a known date of progression (or death), PFS was the earlier of date of progression or death - date of first administration + 1. The date of progression and date of first administration referred to the respective part of the study B.|From first drug administration until end of Part B, up to 230 days.|TRT B Treated set (Part B): All patients who received at least one dose each of Afatinib and Vinorelbine in Part B.||Days||95% Confidence Interval|Median
840058|NCT01325428|Secondary|Part A: Progression Free Survival.|PD was evaluated according to the RECIST version 1.1. For patients with a known date of progression (or death), PFS was the earlier of date of progression or death - date of first administration + 1. The date of progression and date of first administration referred to the respective part of the study A.|From first drug administration until end of Part A, up to 713 days.|TRT A Treated Set (Part A): All patients who were documented to have taken at least one dose of Afatinib in Part A.||Days||95% Confidence Interval|Median
840059|NCT01325428|Secondary|Part B: Duration of Unconfirmed Objective Response.|Objective response was defined on a patient level as a best response of CR or PR. Duration of objective response was measured from the time of first unconfirmed objective response to the time of progression or death (or date of censoring for PFS).|From first drug administration until end of Part B, up to 929 days.|TRT B Treated set (Part B): All patients who received at least one dose each of Afatinib and Vinorelbine in Part B.||Days||95% Confidence Interval|Median
840060|NCT01325428|Secondary|Part A: Duration of Unconfirmed Objective Response.|Objective Response (OR) was defined on a patient level as a best response of Complete Response (CR) or Partial Response (PR). Duration of objective response was measured from the time of first unconfirmed objective response to the time of progression or death (or date of censoring for Progression Free Survival (PFS)).|From first drug administration until end of Part A, up to 929 days.|TRT A Treated Set (Part A): All patients who were documented to have taken at least one dose of Afatinib in Part A.||Days||95% Confidence Interval|Median
840061|NCT01325428|Secondary|Part B: Unconfirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1 ).|Objective response was defined on a patient level as a best response of CR or PR.|This endpoint was recorded from first administration of trial medication in Part B and until the earliest of PD, death or start of new anti-cancer therapy up to 929 days.|TRT B Treated set (Part B): All patients who received at least one dose each of Afatinib and Vinorelbine in Part B.||Percentage of participants||95% Confidence Interval|Number
840062|NCT01325428|Secondary|Part A: Unconfirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1).|Objective response was defined on a patient level as a best response of CR or PR.|This endpoint was recorded from first administration of trial medication until the earliest of PD, death or start of next treatment (either Part B combination therapy or new anti-cancer therapy) up to 929 days.|TRT A Treated Set (Part A): All patients who were documented to have taken at least one dose of Afatinib in Part A.||Percentage of participants||95% Confidence Interval|Number
840063|NCT01325428|Secondary|Part B: Confirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1).|Objective response was defined on a patient level as a best response of CR or PR.|This endpoint was recorded from first administration of trial medication in Part B and until the earliest of disease progression, death or start of new anti-cancer therapy up to 929 days.|TRT B Treated set (Part B): All patients who received at least one dose each of Afatinib and Vinorelbine in Part B.||Percentage of participants||95% Confidence Interval|Number
840064|NCT01325428|Secondary|Part A: Confirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1).|Objective response was defined on a patient level as a best response of CR or PR.|This endpoint was recorded from first administration of trial medication until the earliest of disease progression, death or start of next treatment (either Part B combination therapy or new anti-cancer therapy) up to 929 days.|TRT A Treated Set (Part A): All patients who were documented to have taken at least one dose of Afatinib in Part A.||Percentage of participants||95% Confidence Interval|Number
840065|NCT01325428|Primary|Part B: Clinical Benefit (CB) Assessed by Complete Response (CR), Partial Response (PR) or Stable Disease (SD) for at Least 6 Months Using the Response Evaluation Criteria in Solid Tumours (RECIST 1.1).|Tumour response was assessed separately for Part B according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The primary endpoint of this study was confirmed clinical benefit, as assessed by Stable Disease (SD) for at least 6 months (defined as >182 days), Partial Response (PR), or Complete Response (CR) according to RECIST version 1.1 (only confirmed responses were considered).|This endpoint was recorded from first administration of trial medication in Part B until the earliest of PD, death or start of new anti-cancer therapy up to 929 days.|TRT B Treated set (Part B): All patients who received at least one dose each of Afatinib and Vinorelbine in Part B.||Percentage of participants||95% Confidence Interval|Number
840066|NCT01325428|Primary|Part A: Clinical Benefit (CB) Assessed by Complete Response (CR), Partial Response (PR) or Stable Disease (SD) for at Least 6 Months Using the Response Evaluation Criteria in Solid Tumours (RECIST 1.1).|Tumour response was assessed separately for Part A and Part B according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The primary endpoint of this study was confirmed clinical benefit, as assessed by Stable Disease (SD) for at least 6 months (defined as >182 days), Partial Response (PR), or Complete Response (CR) according to RECIST version 1.1 (only confirmed responses were considered).|This endpoint was assessed between the from first administration of trial medication in Part A and the earliest of PD, death or start of next treatment (either Part B combination therapy or new anti-cancer therapy) up to 929 days.|TRT A Treated Set (Part A): All patients who were documented to have taken at least one dose of Afatinib in Part A.||Percentage of participants||95% Confidence Interval|Number
840067|NCT01325493|Secondary|Pain Score During Cough.|Patient volunteered response during a cough, 1-10 scale (where a higher score indicates more pain and a lower score indicates less pain). Values are for each 24 hour time period and displayed as hours post surgery.|24, 48, 72, 96 hours post operatively|||pain score at cough||Standard Deviation|Mean
840068|NCT01325493|Secondary|Pain Score at Rest|Patient volunteered response at rest, 1-10 scale (where a higher score indicates more pain and a lower score indicates less pain). Values are for each 24 hour time period and displayed as hours post surgery.|24, 48, 72, 96 hours post operatively|||pain score at rest||Standard Deviation|Mean
840071|NCT01325532|Secondary|Change in Global Sleep Scores on the Pittsburgh Sleep Quality Index (PSQI) From Baseline to Week 3.|The Pittsburgh Sleep Quality Index (PSQI) is a patient-rated instrument to assess sleep quality and quantity and its changes throughout the study. Scoring is based on 7 individual components. Each component is scored from 0-3. Higher scores indicate worse sleep. Total global sleep score ranges from zero (0) to 21. We report here the overall change in global sleep score for each treatment arm, i.e. the change in overall score between baseline visit and week 3 visit. Change can occur in either direction (i.e. improvement or worsening). A score of greater than zero indicates a reduction of sleep disturbance (improvement), whereas a score of less than zero indicates an increase in sleep disturbance (worsening).|Baseline-Week 3|This is an intent to treat (ITT) analysis of all patients randomized.||units on a scale||Standard Deviation|Mean
840072|NCT01325532|Primary|Reported Side Effects Based on PRISE AE Scores|This measures the emergence of different adverse (side) effects from treatment during the study. This section will describe the most commonly reported adverse effects. The section on adverse events will describe and detail the full range of AEs reported.|Baseline-Week 3|Intent to treat sample with all subjects randomized.||number of subjects reporting|||Number
840073|NCT01325532|Primary|Change in Hamilton Depression Rating Scale (HAM-D 17) Score From Baseline to Week 3|The Hamilton Depression Rating Scale (HAM-D-17) used here is a 17-item scale that measures severity of depression. Items are individually scored from 0-4 or from 0-2 depending on the item, and the individual scores for each item are added to comprise one score. Higher scores indicate greater severity of depression. Possible scores on the scale range from a minimum of zero (0) to a maximum of 52. This section reports the improvement in depressive symptoms during the course of treatment, i.e. the change in overall score between baseline visit and week 3 visit. Change can occur in either direction (i.e. improvement or worsening). A score of greater than zero indicates a reduction of depressive symptoms (improvement), whereas a score of less than zero indicates an increase in depressive symptoms (worsening).|Baseline-Week 3|Intent to treat sample with last observation carried forward for all randomized subject.||units on a scale||Standard Deviation|Mean
840074|NCT01325623|Secondary|Post-stimulation Heart Rate Changes|During a 1 hour period during the EMU stay, the VNS Therapy device was programmed to normal mode stimulation ON time 30 seconds, OFF time 5 minutes. AutoStim and Magnet Mode were programmed OFF. In this hour, 10 to 11 normal mode stimulations can be expected. Around each of these stimulations, ECG data were collected to assess potential stimulation related heart rate changes (during stimulation, after stimulation and after black-out time). A black-out time is a period after stimulation during which no seizure detections can occur, to ensure that potential stimulation related heart rate changes were not seen as ictal tachycardia that would trigger false positive detection. During the trial, the black-out time was programmed to 30 seconds. The heart rate changes for all stimulations and all patients were averaged.|EMU stay|ITT population||percentage change||Standard Deviation|Mean
840075|NCT01325623|Secondary|Overall Summary of Seizure Intensity by Subgroup|Quantitative evaluation of EEG was used to characterize the seizures that were treated with Automatic Stimulation. Intensity was evaluated by surveying the average power level from the 10-20 system EEG channel of maximum output during the course of the seizure. Intensity was only reported for seizures with intensity annotated and >= 20% Heart Rate Rise. The relative intensity was calculated by normalizing the power calculations to the pre-seizure state, and thus the reported changes are dimensionless. n= number of seizures|Historical Seizures and Seizures during Epilepsy Monitoing Unit Stay|Patients from the ITT population who had at least one seizure during EMU stay and who had at least one historical seizure recorded. n=total number of seizures||unitless||Standard Deviation|Mean
840076|NCT01325623|Secondary|Changes in Quality of Life on Patient Reported Questionnaire (QOLIE-31-P)|Quality of life data was collected using patient‐completed QOLIE‐31‐P surveys and compared between baseline and follow‐up visits. The MIC score for each subscale defines the threshold for Minimally Important Change. If a score exceeds the MIC Score, the improvement from baseline is considered clinically significant. The range for QOLIE-31-P (all sub-scores) is 0-100 with higher scores reflecting greater well-being.Subscale scores were averaged to compute the QOLIE Total Score.|up to 24 Months Visit|ITT Population||units on a scale||Standard Deviation|Mean
840077|NCT01325623|Secondary|Summary of Post Ictal Duration (Seconds) for All Seizure Types (ITT Population) (Only Seizures With Post Ictal Duration (Seconds) Annotated)|Post-ictal duration was quantified by identifying the time at which the number of EEG channels within the 95% confidence interval of relative power reaches a number that is consistent with that during the pre-seizure period. This measure represents the amount of time required following a seizure until the EEG recovers to the pre-seizure state. It is used to objectively estimate patient recovery time. Historical seizures were baseline EEG recordings measured during monitoring prior to implantation. Post-ictal duration is only reported for seizures with Post Ictal Duration (seconds) annotated and >= 20% Heart Rate Rise|Historical Seizures and Seizures during Epilepsy Monitoring Unit Stay|Patients from the ITT population who had at least one seizure during the EMU stay and who had at least one historical seizure recorded (and duration was annotated). n=total number of seizures||Seconds||Standard Deviation|Mean
840078|NCT01325623|Secondary|Summary of Seizure Duration (Seconds) for All Seizure Types by Subgroup(ITT Population) (Only Seizures With Post Ictal Duration (Seconds) Annotated)|Seizure duration was calculated using historical EEG data from patients enrolled in the trial and compared to the duration of seizures that occurred during the study EMU stay. The seizure start and end times were determined via clinical observation and/or through an adjudication process with qualified EEG reviewers.|Historical Seizures and Seizures during Epilepsy Monitoring Unit Stay|Patients from the ITT population who had at least one seizure during the EMU stay and who had at least one historical seizure recorded (and duration was annotated). n=total number of seizures||Seconds||Standard Deviation|Mean
840079|NCT01325623|Secondary|Proportion of Seizures Ending During Stimulation by Type|Clinical outcomes including seizure duration and cessation were assessed with vEEG during EMU stay. Number of seizures treated with Automatic Stimulation during EMU were evaluated. Of these seizures, those ending during the 60 second course of Automatic Stimulation were assessed and tabulated by seizure type.|Epilepsy Monitoring Unit (EMU) Stay|ITT Population; All Treated Seizures n=total number of seizures||Percentage of Seizures Ending|||Number
840102|NCT01331837|Secondary|Time to First Occurrence of Individual Component of Primary Endpoint: Cardiovascular Death|Prospective comparison of time to first occurrence of Individual component of primary endpoint: cardiovascular death|From baseline up to 4.9 years|Analysis was conducted on the ITT population||Months||95% Confidence Interval|Median
840080|NCT01325623|Secondary|Changes in Seizures Severity, Intensity & Post-Ictal Recovery Based on Patient Completed Seizure Severity Questionnaire (SSQ)|"Clinical outcomes such as seizure severity, intensity and post-ictal duration were also assessed during the long-term follow-up visits (3, 6, 12, 18 and 24 months) with patient reported questionnaires (SSQ; Seizure Severity Questionnaire). The range for SSQ (all sub-scores) is 1-7 with 1 being the least severe and 7 being the most severe.
Mean SSQ scores at 3, 6, 12, 18 and 24 months were compared to baseline. A change from baseline is calculated as baseline minus follow-up visit score to correspond to the Minimally Important Change (MIC) criteria as defined in the Scoring Scheme for SSQ v2. Questionnaire. Subscale scores were averaged to compute the SSQ Total Score"|Up to 24 Month visit|ITT Population||Units on a scale||Standard Deviation|Mean
840081|NCT01325623|Secondary|Changes in Seizure Severity Based on Physician Reported Questionnaire (NHS3)|"Investigators completed the National Hospital Seizure Severity Scale (NHS3) questionnaire at screening, at the end of the EMU stay (provided a seizure occurred during the EMU stay), and at follow‐up visits. Severity was evaluated by seizure type. The range of NHS3 scale is 1-27 with 1 being the least severe and 27 being the most severe.
Negative median value means improvement."|up to 24 Months Visit|ITT Population||Units on a scale||Full Range|Median
840082|NCT01325623|Secondary|Changes From Baseline in Seizure Frequency|Seizure frequency was calculated at 3, 6, 12, 18 and 24 month follow-up visits based on seizure diary information and compared to baseline estimates. Response rate was computed and summarized for partial seizures (SPS, CPS and CPS with 2nd GTCs) and overall seizure types as the percentage of patients that achieved ≥50% seizure reduction per month from baseline by visit.|Up to 24 Month visit|ITT population||Percentage of participants||95% Confidence Interval|Number
840083|NCT01325623|Secondary|Human Factors and Usability of the AspireSR® VNS Therapy® System.|"Usability survey data were collected from all site personnel who used the handheld programmer to evaluate the usability of the AspireSR® VNS Therapy® System.The device usability survey contained 17 questions that measure usability on a five-point Likert scale ranging from Extremely Difficult (5) to Extremely Easy (1). Site personnel were asked to assess usability of the software features, instructions for use, training materials, and overall usability of the system at four different time points. The time points include implant/recovery and the end of EMU.
Usability was calculated as percentage of the users who found the usability of system to be easy-2 or extremely easy-1."|At implant/recovery up to EMU Discharge (2 to 4 weeks)|ITT Population||Percentage of participants rated 1 or 2|||Number
840084|NCT01325623|Secondary|Characterization of Latency Period: Analysis of Observed Latency for True Positive Detections by Randomized SDA Setting|Latency is defined as the time difference between SDA detection time and the annotated seizure onset time. The earliest SDA detection was considered for each seizure. Seizure onset times were compared with M106 device detections at the randomized SDA setting. Negative latencies indicate that the SDA detection preceded the seizure onset time. The median latency is presented for seizures which met the definition of ictal tachycardia as well as all seizure types and indicate the observed latency range.|Epilepsy Monitoring Unit (EMU) Stay|ITT Population n=total number of seizures in each category||seconds||Full Range|Median
840085|NCT01325623|Secondary|Validation of Cardiac R-Wave Detection|Cardiac R‐wave detection was evaluated against concurrent ECG data (i.e. detailed R‐wave test) collected during implant, the first titration visit, at the beginning of the EMU stay, and at the 12 month visit. R‐R intervals were calculated using detected R‐waves from the Implantable Pulse Generator (IPG) and from a standard ECG monitor during a pre‐specified time interval. A time series 10 seconds was recorded using the IPG SyncPulse feature. Simultaneously, a corresponding time series over the same interval was recorded using a standard ECG monitor. The total number of beats accurately detected in the entire study population is reported.|At Implant, First Titration Visit, Day 1 EMU and 12 Months|ITT population||percentage of beats accurately detected|||Number
840086|NCT01325623|Primary|Potential False Positives Based on Heart Rate Increase Associated With Seizures by Randomized SDA Setting|"Potential false positive rate is defined as the sum across all patients of the total number of potential false positive detections divided by the sum across all patients of the appropriate monitoring time during the EMU stay. Data used to support the potential false positive rate analyses included digital ECG/EEG files retrieved from the EMU evaluation, corresponding M106 device downloads, and triple review results of EEG recordings.
The evaluated EMU monitoring time includes a daily 3 minutes stepping exercise during which patients stepped up and down on a step stool at a submaximal effort leve."|Epilepsy Monitoring Unit (EMU) Stay|"ITT Population: all patients implanted with Model 106 VNS Therapy System Version 2 and who have any EMU record.
10 participants analyzed for >=60% setting, 12 participants analyzed for >=40% setting, 8 participants analyzed for >=20% setting."||Potential False Positive per Hour||95% Confidence Interval|Number
840087|NCT01325623|Primary|Modeled Sensitivity Based on Heart Rate Increase Associated With Seizures by SDA Setting Post-Processed Through Bench-top Device Simulant|"Sensitivity is defined as the total number of seizures detected divided by the total number of seizures during the EMU stay. Data used to support sensitivity analyses included digital ECG/EEG files, corresponding M106 device downloads, and CRF data. Seizure onset times were compared with modeled M106 device detections at the least sensitive setting capable of detecting the seizure based on the corresponding change in heart rate. The participants' surface ECG data collected during the trial and passed through DMSDAT, a validated bench‐top simulant of the Automatic Stimulation feature, was used to produce modeled results for each threshold for AutoStim setting (1;70%, 2;60%, 3;50%, 4;40%, 5;30% and 6;20%). Number of participants is total number of subjects who experienced seizures during the EMU stay.
Bootstrap confidence intervals using 3000 bootstrap samples."|Epilepsy Monitoring Unit (EMU) Stay|Patients from the ITT population who completed the EMU evaluation and that had at least one reported seizure during the EMU evaluation that was confirmed by triple review; (Investigator Reported Seizures + Triple Review).||percentage of True Positive Detections||95% Confidence Interval|Mean
840103|NCT01331837|Secondary|Percentage of Patients With Individual Component of Primary Endpoint: Non-fatal Myocardial Infarction|Percentage of patients reporting Individual component of primary endpoint: non-fatal Myocardial Infarction|From baseline up to 4.9 years|Anlysis was conducted on the ITT population||Percentage of patients|||Number
840104|NCT01331837|Secondary|Time to First Occurrence of Individual Component of Primary Endpoint: Non-fatal Myocardial Infarction|Prospective comparison of time to first occurrence of Individual component of primary endpoint: non-fatal Myocardial Infarction|From baseline up to 4.9 years|Anlysis was conducted on the ITT population.||Months||95% Confidence Interval|Median
840088|NCT01325623|Primary|Observed Sensitivity Based on Heart Rate Increase Associated With Seizures by Randomized SDA Setting|"Sensitivity is the total number of seizures detected divided by the total number of seizures during EMU stay.Data used to support sensitivity analyses included digital ECG/EEG files,corresponding M106 device downloads,and CRF data.Seizure and non-seizure EEG segments were provided to independent reviewers to confirm seizure occurrence and define EEG seizure onset times.Seizure onset times were then compared with observed M106 device detections at the detection threshold setting for AutoStim that the patient was randomized to(SDA 2;60%,SDA 4;40%,SDA 6;20%).Sensitivity is only reported if the heart rate surpassed the programmed detection threshold.Number of participants is total number of subjects who had seizures during the EMU stay.
An Ictal tachycardia Seizure is a seizure with Ictal Heart rate >= 100 bpm & at least 55% increase, or 35 bpm increase from baseline) Bootstrap confidence intervals using 3000 bootstrap samples. n=total number of seizures; N= number of participants"|Epilepsy Monitoring Unit (EMU) Stay|Patients from the ITT population who completed the EMU evaluation and that had at least one reported seizure during the EMU evaluation that was confirmed by triple review; (Investigator Reported Seizures + Triple Review).||percentage of True Positive Detections||95% Confidence Interval|Mean
840089|NCT01325623|Primary|Summary of Seizures Reported by Investigators and Triple Review|"Subjects were admitted to the EMU and underwent standard continuous data collection of vEEG and ECG for 3 to 5 days. If a seizure occurred during the EMU stay, clinical investigators annotated the start and stop times, the type of seizure, the presumed seizure onset location, and the lobe of origin as applicable.
Following the EMU data collection phase of the trial, the de-identified, continuous electronic records (per patient) from the EMU period were provided to an independent and blinded triple review panel. This panel evaluated the EEG data and annotated seizure onset, seizure offset, and a description of seizure type. In the absence of video, seizure types could only be specified as: partial (particular type not denoted), generalized (non-absence), absence, or partial with secondary generalization."|Epilepsy Monitoring Unit Stay|ITT Population: consists of all patients implanted with the AspireSR VNS Therapy System version 2 and who have any EMU record.||Seizures|||Number
840090|NCT01325701|Secondary|Ibrutinib and Its Metabolite (PCI-45227) AUC0-24h After Repeat Dosing of PCI-32765|"Treatment Group 1 PK collection schedule:
Cycle 1 Day 1: Pre-dose, 1, 2, 4, 7, and 24 hours post-dose Cycle 1 Day 8: Pre-dose, 1, 2, 4, 7, and 24 hours post-dose Cycle 1 Day 15: Pre-dose and 2 hours post-dose Cycle 1 Day 22: Pre-dose and 2 hours post-dose
Treatment Group 2 PK collection schedule:
Cycle 1 Day 8: Pre-dose, 1, 2, 4 and 7 hours post-dose Cycle 1 Day 15: Pre-dose and 2 hours post-dose Cycle 1 Day 22: Pre-dose and 2 hours post-dose Cycle 3 Day 1: Pre-dose, 1, 2, and 4 hours post-dose"|Performed during the first month of receiving study drug.|PK samples were collected in all participants (n=70 and 8 in PCI-32765: 560 mg and 840 mg, respectively). Of these, 59 participants in PCI-32765: 560 mg and 7 in PCI-32765: 840 mg on Cycle 1 Day 8 were evaluable for PK.||ng*h/mL||Standard Deviation|Mean
840091|NCT01325701|Secondary|Number of Patients With Adverse Events as a Measure of Safety and Tolerability|Participants will be followed until progression of the disease or start of another anticancer treatment. The clinical database captured all AEs from baseline through end of treatment. Treatment Emergent AEs were collected pre-dose, at the beginning of each cycle and 30 days post last dose of study drug, unless related to study drug.|Adverse events determined to be related to study drug are collected from first dose until study exit (approximately 3 years).|||participants|||Number
840092|NCT01325701|Primary|Percentage of Patients With an Overall Response to Study Drug|The primary endpoint of the study was overall response rate (ORR), defined as the proportion of participants who achieved a best overall response of complete response (CR) or partial response (PR), according to the revised International Working Group Criteria for non-Hodgkin’s lymphoma (Cheson et al, 2007), as assessed by the investigator.|The median follow up time on the study for all treated participants is 1.7 months (range 0.1- 32.3 months)|||percentage of participants|||Number
840093|NCT01331824|Secondary|Safety as Measured by the Frequency and Type of Adverse Events as Per the Common Terminology for Adverse Events (CTCAE) Version 4.0.||Day 1 of each treatment cycle; and 21 days after the last dose of amrubicin||||||
840094|NCT01331824|Secondary|Overall Survival|The median overall survival|1 year|||months||95% Confidence Interval|Median
840095|NCT01331824|Secondary|Progression-free Survival|"The median progression-free survival
After the last dose of Amrubicin, patients will have follow-up every 3 months with a repeat CT scan of the chest, abdomen, and pelvis until the time of disease progression is documented."|Every 3 months post Amrubicin administration|||months||95% Confidence Interval|Median
840096|NCT01331824|Primary|Objective Response Rate as Measured by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)|"Response to treatment based on tumor measurements via CT chest, abdomen, and pelvis for restaging after every 2 cycles.
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study."|6 weeks|||percentage of participants||95% Confidence Interval|Number
840097|NCT01331837|Secondary|Percentage of Patients With Individual Component of Primary Endpoint: All-cause Mortality|Percentage of patients reporting Individual component of primary endpoint: All-cause mortality|From baseline up to 4.9 years|Analysis was conducted on the ITT population.||Percentage of patients|||Number
840098|NCT01331837|Secondary|Time to First Occurrence of Individual Component of Primary Endpoint: All-cause Mortality|Prospective comparison of time to first occurrence of Individual component of primary endpoint: All-cause mortality|From baseline up to 4.9 years|Analysis was conducted on the ITT population.||Months||95% Confidence Interval|Median
840099|NCT01331837|Secondary|Percentage of Patients With Individual Component of Primary Endpoint: Non-fatal Stroke||From baseline up to 4.9 years|Analysis was conducted on the ITT population||Percentage of patients|||Number
840100|NCT01331837|Secondary|Time to First Occurrence of Individual Component of Primary Endpoint: Non-fatal Stroke|Prospective comparison of time to first occurrence of Individual component of primary endpoint: non-fatal stroke|From baseline up to 4.9 years|Analysis was conducted on the ITT population||Months||95% Confidence Interval|Median
840101|NCT01331837|Secondary|Percentage of Patients With Individual Component of Primary Endpoint: Cardiovascular Death|Percentage of patients reporting Individual component of primary endpoint: cardiovascular death|From baseline up to 4.9 years|Analysis was conducted on the ITT population||Percentage of patients|||Number
840105|NCT01331837|Secondary|Percentages of Participants With an Expanded CV Composite Endpoint|Percentages of participants with the expanded CV composite endpoint. The expanded composite endpoint is defined as the CV composite of the primary endpoint with the addition of non-elective coronary revascularization procedures and hospitalization for unstable angina.|From baseline up to 4.9 years|Analysis was conducted on the ITT population.||Percentages of participants|||Number
840106|NCT01331837|Secondary|The Time to First Occurrence of an Expanded CV Composite Endpoint|Prospective comparison of the time to first ccurrence of the expanded composite endpoint. The expanded composite endpoint is defined as the CV composite of the primary endpoint with the addition of non-elective coronary revascularization procedures and hospitalization for unstable angina.|From baseline up to 4.9 years|Analysis was conducted on the ITT population.||Months||95% Confidence Interval|Median
840107|NCT01331837|Primary|Percentage of Participants With a CV-EAC Adjudicated Event Before Last Direct Contact Date|Percentage of participants with any component of the composite of CV death (including events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke before last direct contact date (i.e., latest date of visit, IVRS call, or site call).|From Baseline up to 4.9 years|Analysis was conducted on the ITT population||Percentage of participants with event|||Number
840108|NCT01331837|Primary|Time to First CV-EAC Adjudicated Event Before Last Direct Contact Date|Prospective comparison of time to first occurrence of any component of the composite of CV death (including events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke before last direct contact date (i.e., latest date of visit, IVRS call, or site call).|From Baseline up to 4.9 years|Analysis was conducted on the ITT population||Months||95% Confidence Interval|Median
840109|NCT01331837|Primary|Percentage of Patients With a CV-EAC Adjudicated Event Excluding Undetermined Cause of Death - Sensitivity Analysis|Percentage of patients with any component of the composite of CV death (excluding events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke - Sensitivity Analyses|From baseline up to 4.9 years|Analysis was conducted on the ITT population||Percentage of patients with event|||Number
840110|NCT01331837|Primary|Time to First CV-EAC Adjudicated Event Excluding Undetermined Cause of Death - Sensitivity Analysis|Prospective comparison of time to first occurrence of any component of the composite of CV death (excluding events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke - Sensitivity Analyses|From baseline up to 4.9 years|Analysis was conducted on the ITT population||Months||95% Confidence Interval|Median
840111|NCT01331837|Primary|Percentage of Patients With a CV-EAC Adjudicated Event - Sensitivity Analysis|Percentage of patients with any component of the composite of CV death (including events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke - Sensitivity Analysis|From Baseline up to 4.9 years|Analyses was conducted on the On-treatment (OT) population, i.e. patients who switched from randomized treatment were censored at the time of treatment switching.||Percentage of patients with event|||Number
840112|NCT01331837|Primary|Time to First CV-EAC Adjudicated Event - Sensitivity Analysis|Prospective comparison of time to first occurrence of any component of the composite of CV death (including events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke - Sensitivity Analysis|From Baseline up to 4.9 years|Analyses was conducted on the On-treatment (OT) population, i.e. patients who switched from randomized treatment were censored at the time of treatment switching.||Months||95% Confidence Interval|Median
840113|NCT01331837|Primary|Percentage of Patients Reporting a Cardiovascular (CV) Events Adjudication Committee (EAC) (CV-EAC) Adjudicated Event|Percentage of patients reporting any component of the composite of CV death (including events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke|From baseline up to 4.9 years|Analysis was conducted on the Intention to treat (ITT) population, i.e. all patients randomized who have taken at least one dose of study medication||Percentage of patients with event|||Number
840114|NCT01331837|Primary|Time to First Cardiovascular (CV) Events Adjudication Committee (EAC) (CV-EAC) Adjudicated Event|Prospective comparison of time to first occurrence of any component of the composite of CV death (including events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke.|From baseline up to 4.9 years|Analysis was conducted on the Intention to treat (ITT) population, i.e. all patients randomized who have taken at least one dose of study medication||Months||95% Confidence Interval|Median
840115|NCT01332019|Secondary|Summary of Participant-Reported Treatment Satisfaction: Main Reason for Missed Injections|"Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant’s perception of treatment satisfaction at the end of each year of treatment. For the question Main reason for missed injections? answer choices were given as medication side effects, injection pain, forget to take medication, tired of taking injections, don't think medication is working, or other. Data after Amendment 3 took effect are excluded."|Year 1, Year 2, Year 3|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment who missed at least 1 injection at given timepoint.||participants|||Number
840116|NCT01332019|Secondary|Summary of Participant-Reported Treatment Satisfaction: Over the Past 4 Weeks, Did You Miss Any of Your Injections?|"Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant’s perception of treatment satisfaction at the end of each year of treatment. For the question Over the past 4 weeks, did you miss any of your injections? answer choices were given as none missed, miss 1 injection, or miss 2 injections. Data after Amendment 3 took effect are excluded."|Year 1, Year 2, Year 3|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.||participants|||Number
840117|NCT01332019|Secondary|Summary of Participant-Reported Treatment Satisfaction: I Am Satisfied With the Dosing Frequency of This Medication.|"Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant’s perception of treatment satisfaction at the end of each year of treatment. For the statement I am satisfied with the dosing frequency (2 times per month) of this medication answers were numerically rated from 1 (strongly disagree) to 10 (strongly agree). Data after Amendment 3 took effect are excluded."|Year 1, Year 2, Year 3|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.||units on a scale||Standard Deviation|Mean
840118|NCT01332019|Secondary|Summary of Participant-Reported Treatment Satisfaction: This Medication Improves My Self-Confidence and Self-Reliance.|"Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant’s perception of treatment satisfaction at the end of each year of treatment. For the statement This medication improves my self-confidence and self-reliance, answers were numerically rated from 1 (strongly disagree) to 10 (strongly agree). Data after Amendment 3 took effect are excluded."|Year 1, Year 2, Year 3|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.||units on a scale||Standard Deviation|Mean
840119|NCT01332019|Secondary|Summary of Participant-Reported Treatment Satisfaction: The Twice a Month Dosing Enables Me to Be More Spontaneous and Flexible.|"Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant’s perception of treatment satisfaction at the end of each year of treatment. For the statement The twice a month dosing enables me to be more spontaneous and flexible, answers were numerically rated from 1 (strongly disagree) to 10 (strongly agree). Data after Amendment 3 took effect are excluded."|Year 1, Year 2, Year 3|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.||units on a scale||Standard Deviation|Mean
840120|NCT01332019|Secondary|Summary of Participant-Reported Treatment Satisfaction: The Twice a Month Dosing Makes It More Convenient for Me to Travel/Vacation.|"Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant’s perception of treatment satisfaction at the end of each year of treatment. For the statement The twice a month dosing makes it more convenient for me to travel/vacation, answers were numerically rated from 1 (strongly disagree) to 10 (strongly agree). Data after Amendment 3 took effect are excluded."|Year 1, Year 2, Year 3|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.||units on a scale||Standard Deviation|Mean
840121|NCT01332019|Secondary|Summary of Participant-Reported Treatment Satisfaction: This Medication Makes It Easy For Me to Carry Out My Daily Responsibilities.|"Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant’s perception of treatment satisfaction at the end of each year of treatment. For the statement This medication makes it easy for me to carry out my daily responsibilities (ie, going to work, doing household chores or caring for my family), answers were numerically rated from 1 (strongly disagree) to 10 (strongly agree). Data after Amendment 3 took effect are excluded."|Year 1, Year 2, Year 3|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.||units on a scale||Standard Deviation|Mean
840122|NCT01332019|Secondary|Summary of Participant-Reported Treatment Satisfaction: This Medication Enables Me to Focus More on Myself and My Family Rather Than My MS.|"Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant’s perception of treatment satisfaction at the end of each year of treatment. For the statement This Medication Enables Me to Focus More on Myself and My Family Rather Than My MS, answers were numerically rated from 1 (strongly disagree) to 10 (strongly agree). Data after Amendment 3 took effect are excluded."|Year 1, Year 2, Year 3|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.||units on a scale||Standard Deviation|Mean
840123|NCT01332019|Secondary|Summary of Participant-Reported Treatment Satisfaction: How Likely Would You Be to Continue to Use This Medication?|"Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant’s perception of treatment satisfaction at the end of each year of treatment. For the question How likely would you be to continue to use this medication? answers were numerically rated from 1 (extremely unlikely) to 10 (extremely likely). Data after Amendment 3 took effect are excluded."|Year 1, Year 2, Year 3|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.||units on a scale||Standard Deviation|Mean
840124|NCT01332019|Secondary|Summary of Participant-Reported Treatment Satisfaction: How Satisfied or Dissatisfied Are You With the Injection Frequency (Every 2 Weeks)?|"Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant’s perception of treatment satisfaction at the end of each year of treatment. For the question How satisfied or dissatisfied are you with the injection frequency (every 2 weeks)? answers were numerically rated from 1 (extremely dissatisfied) to 10 (extremely satisfied). Data after Amendment 3 took effect are excluded."|Year 1, Year 2, Year 3|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.||units on a scale||Standard Deviation|Mean
840125|NCT01332019|Secondary|Summary of Participant-Reported Treatment Satisfaction: Overall, How Satisfied or Dissatisfied Are You With This Medication?|"Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant’s perception of treatment satisfaction at the end of each year of treatment. For the question Overall, how satisfied or dissatisfied are you with this medication? answers were numerically rated from 1 (extremely dissatisfied) to 10 (extremely satisfied). Data after Amendment 3 took effect are excluded."|Year 1, Year 2, Year 3|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.||units on a scale||Standard Deviation|Mean
840126|NCT01332019|Secondary|Summary of Participant-Reported Treatment Satisfaction: How Convenient or Inconvenient Is It to Take Your Medication Every 2 Weeks?|"Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant’s perception of treatment satisfaction at the end of each year of treatment. For the question How convenient or inconvenient is it to take your medication every 2 weeks? answers were numerically rated from 1 (extremely inconvenient) to 10 (extremely convenient). Data after Amendment 3 took effect are excluded."|Year 1, Year 2, Year 3|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.||units on a scale||Standard Deviation|Mean
840244|NCT01333956|Secondary|Self-assessed Sedation and Confusion|Self-assessed sedation and confusion (POD1). Confusion Assessment Method (CAM score) (pre-operative and on POD1)|1 day postoperatively|||percentage of patients|||Number
840127|NCT01332019|Secondary|Summary of Participant-Reported Treatment Satisfaction: How Convenient or Inconvenient Is It to Take Your Medication as Instructed?|"Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant’s perception of treatment satisfaction at the end of each year of treatment. For the question How convenient or inconvenient is it to take your medication as instructed? answers were numerically rated from 1 (extremely inconvenient) to 10 (extremely convenient). Data after Amendment 3 took effect are excluded."|Year 1, Year 2, Year 3|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.||units on a scale||Standard Deviation|Mean
840128|NCT01332019|Secondary|Summary of Participant-Reported Treatment Satisfaction: How Tolerable or Intolerable Do You Find the Medication?|"Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant’s perception of treatment satisfaction at the end of each year of treatment. For the question How tolerable or intolerable do you find the medication? answers were numerically rated from 1 (extremely intolerable) to 10 (extremely tolerable). Data after Amendment 3 took effect are excluded."|Year 1, Year 2, Year 3|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.||units on a scale||Standard Deviation|Mean
840129|NCT01332019|Secondary|Number of MS-Related Hospitalizations|Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.|up to 4 years|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment||hospitalizations|||Number
840130|NCT01332019|Secondary|Number of Relapses Requiring IV Steroid Use|Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.|up to 4 years|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment||relapses|||Number
840131|NCT01332019|Secondary|Change From Baseline in EQ-5D Visual Analogue Scale (VAS)|The EQ-5D VAS records the participant's self-rated health on a scale from 0-100 where 100 is the 'best imaginable health state' and 0 is the 'worst imaginable health state.' The scale was normalized to a scale of 0 to 1, with higher values indicating a better health state. Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.|Baseline (start of 105MS302), Weeks 24, 48, 72, 96, 120, 144, 168|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.||units on a scale||Standard Deviation|Mean
840132|NCT01332019|Secondary|Change From Baseline in Euro Quality of Life (EQ-5D) Index Score|The EQ-5D is a participant-answered questionnaire scoring 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Scores of 1, 2, or 3 are possible responses for each of 5 questions (1=no problems, 2=some problems, 3=severe problems). A scoring formula developed by the EuroQol Group is then used to assign utility values for each participant’s Health State Profile. A summary index score (EQ-5D index score) is derived from the 5 questions by conversion with this scoring formula and a table of scores. EQ-5D Summary Index values ranged from -0.6 (worst health state) to 1.00 (perfect health state). Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.|Baseline (start of 105MS302), Weeks 24, 48, 72, 96, 120, 144, 168|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.||units on a scale||Standard Deviation|Mean
840133|NCT01332019|Secondary|Change From Baseline in SF-12 Physical Component Score (PCS)|The SF-12 is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey. The questions were combined, scored, and weighted to create two scales that provide glimpses into mental and physical functioning and overall health-related-quality of life. PCS was computed using the scores of 12 questions and range from 0 to 100, where a 0 score indicates the lowest level of health and 100 indicates the highest level of health. Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.|Baseline (start of 105MS302), Weeks 24, 48, 72, 96, 120, 144, 168|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.||units on a scale||Standard Deviation|Mean
840134|NCT01332019|Secondary|Change From Baseline in 12-Item Short Form Health Survey (SF-12) Mental Component Score (MCS)|The SF-12 is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey. The questions were combined, scored, and weighted to create two scales that provide glimpses into mental and physical functioning and overall health-related-quality of life. MCS computed using the scores of 12 questions and range from 0 to 100, where a 0 score indicates the lowest level of health and 100 indicates the highest level of health. Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.|Baseline (start of 105MS302), Weeks 24, 48, 72, 96, 120, 144, 168|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.||units on a scale||Standard Deviation|Mean
840135|NCT01332019|Secondary|Change From Baseline in Multiple Sclerosis Impact Scale (MSIS)-29 Physical Score|The 29-item MSIS-29 is a disease-specific participant-reported outcome measure that has been developed and validated to examine the physical and psychological impact of MS from a patient’s perspective; it measures 20 physical items and 9 psychological items. Responses use a 5-point Likert scale ranging from 1 to 5. All questions are to be answered. The physical well being assessment portion of the MSIS-29 consists of 20 questions in which participants rate the impact of MS on their day-to-day life during the past two weeks from 1=no impact to 5=extreme impact for a total score of 20-100. A lower total score indicates less physically-related impact while a higher total score indicates greater physically-related impact on a participant's functioning. Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.|Baseline (start of 105MS302), Weeks 24, 48, 72, 96, 120, 144, 168|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.||units on a scale||Standard Deviation|Mean
840248|NCT01334125|Secondary|Baseline Adjusted Changes in Adiponectin/Leptin Ratio Over Time|Comparison of the baseline-adjusted differences in adiponectin/leptin ratio over time between the metformin and the placebo groups. The reported values represented mean adjusted for baseline values, age, gender, and BMI using repeated measures ANOVA (General Linear Model).|Baseline, 3mo, 6 mo, and 9 months|||ratio||95% Confidence Interval|Mean
840136|NCT01332019|Secondary|Change From Baseline in Symbol Digit Modalities Test (SDMT)|SDMT is a screening test for cognitive impairment. Participants are given 90 seconds in which to pair specific numbers with given geometric figures using a key. Scores range from 0 (worst) to 110 (best).|Baseline (start of 105MS302), Weeks 24, 48, 72, 96, 120, 144, 168|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.||units on a scale||Standard Deviation|Mean
840137|NCT01332019|Secondary|Time to Sustained Disability Progression|Estimated proportion of participants with progression and time to progression based on the Kaplan-Meier product limit method. Sustained disability progression is defined as: at least a 1.0 point increase on the EDSS from 105MS302 baseline EDSS ≥ 1.0 that is sustained for 24 weeks, or at least a 1.5 point increase on the EDSS from 105MS302 baseline EDSS = 0 that is sustained for 24 weeks. The EDSS measures the disability status of people with multiple sclerosis on a scale that ranges from 0 to 10. The range of main categories include (0) = normal neurologic exam; to (5) = ambulatory without aid or rest for 200 meters; disability severe enough to impair full daily activities; to (10) = death due to MS. Participants were censored at the time of withdrawal/switch/A3 effective date if they withdrew from study, switched to alternative MS medication, or Amendment 3 took effect without a progression.|Weeks 12, 24, 28, 72, 96, 120, 144, 168|Participants in the ITT population (all participants who were assigned a treatment and received at least 1 dose of study treatment) with disability progression.||proportion of participants|||Number
840138|NCT01332019|Secondary|Change From Baseline in Expanded Disability Status Scale (EDSS)|Change from Baseline in disability as measured by the Expanded Disability Status Scale (EDSS). The EDSS measures the disability status of people with multiple sclerosis on a scale that ranges from 0 to 10. The range of main categories include (0) = normal neurologic exam; to (5) = ambulatory without aid or rest for 200 meters; disability severe enough to impair full daily activities; to (10) = death due to MS. Data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.|Baseline (start of 105MS302), Weeks 12, 24, 48, 72, 96, 120, 144, 168|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=number of participants with an assessment at given timepoint.||units on a scale||Standard Deviation|Mean
840139|NCT01332019|Secondary|Percentage Change of Whole Brain Volume|Percentage change of whole brain volume as assessed by MRI. Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.|Baseline (start of 105MS302), Week 48, Week 96|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=number of participants with an assessment at given timepoint.||percentage change||Standard Deviation|Mean
840140|NCT01332019|Secondary|Volume of Gd-Enhancing Lesions|The volume of Gd-enhancing lesions as assessed by MRI. Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.|Baseline (start of 105MS302), Week 48, Week 96|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=number of participants with an assessment at given timepoint.||cm^3||Standard Deviation|Mean
840141|NCT01332019|Secondary|Volume of T1 Hypointense Lesions|The volume of T1 hypointense lesions as assessed by MRI. Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.|Baseline (start of 105MS302), Week 48, Week 96|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=number of participants with an assessment at given timepoint.||cm^3||Standard Deviation|Mean
840142|NCT01332019|Secondary|Volume of T2 Hyperintense Lesions|The volume of T2 hyperintense lesions as assessed by MRI. Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.|Baseline (start of 105MS302), Week 48, Week 96|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=number of participants with an assessment at given timepoint.||cm^3||Standard Deviation|Mean
840143|NCT01332019|Secondary|Number of Gd-Enhancing Lesions|The number of Gd-enhancing lesions as assessed by MRI. Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.|Baseline (start of 105MS302), Week 48, Week 96|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=number of participants with an assessment at given timepoint.||lesions||Standard Deviation|Mean
840144|NCT01332019|Secondary|Number of New T1 Hypointense Lesions|The total number of new T1 hypointense lesions as assessed by MRI.|Week 48, Week 96|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=number of participants with an assessment at given timepoint.||lesions||Standard Deviation|Mean
840145|NCT01332019|Secondary|Number of New Active Lesions|The number of new active lesions as assessed by MRI. Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.|Week 48, Week 96|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=number of participants with an assessment at given timepoint.||lesions||Standard Deviation|Mean
840146|NCT01332019|Secondary|Number of New or Newly Enlarging T2 Hyperintense Lesions|The total number of new or newly enlarging T2 hyperintense lesions (from Study 105MS302 Baseline) as assessed by magnetic resonance imaging (MRI). Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.|Week 48, Week 96|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=number of participants with an assessment at given timepoint.||lesions||Standard Deviation|Mean
840147|NCT01332019|Secondary|Percentage of Participants Who Relapsed|Relapses are defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the examining neurologist. New or recurrent neurologic symptoms that occur less than 30 days following the onset of a relapse were considered part of the same relapse. Participants who did not experience a relapse prior to switching to alternative MS medications, withdrew from study, or Amendment 3 (A3) took effect were censored at the time of switch/withdrawal/A3 effective date.|Up to 4 years|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment.||percentage of participants|||Number
840148|NCT01332019|Secondary|Annualized Relapse Rate (ARR)|Relapses are defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the examining neurologist. The annualized relapse rate is calculated as the total number of relapses occurred during the period for all participants, divided by the total number of person-years followed in the period.|up to 4 years|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment.||relapses per person-years|Relapses|95% Confidence Interval|Number
840149|NCT01332019|Primary|Number of Participants With Shifts From Baseline: Urinalysis|Shift to low includes normal to low, high to low, and unknown to low. Shift to high/positive includes normal to high/positive, low to high/positive, negative to high/positive, and unknown to high/positive. For participants who switched to alternative MS medications, data after switch and 14 days after last dose of study treatment are excluded. Data collected after Amendment 3 took effect were excluded for participants enrolled into study 105MS302 on every 4 week dosing, but not excluded for participants enrolled on every 2 week dosing. Pos=positive; RBC=red blood cells; WBC=white blood cells.|Baseline (BIIB017 Treatment Baseline from Study 105MS301) up to 4 years|Safety population: all participants who received at least 1 dose of study drug; n=number of participants whose baseline value was not low or high/positive and who had at least 1 post-baseline value.||participants|||Number
840150|NCT01332019|Primary|Number of Participants With Shifts From Baseline: Kidney Function and Other Blood Chemistry|Shift to low includes normal to low, high to low, and unknown to low. Shift to high includes normal to high, low to high, and unknown to high. For participants who switched to alternative MS medications, data after switch and 14 days after last dose of study treatment are excluded. Data collected after Amendment 3 took effect were excluded for participants enrolled into study 105MS302 on every 4 week dosing, but not excluded for participants enrolled on every 2 week dosing. TSH=thyroid stimulating hormone.|Baseline (BIIB017 Treatment Baseline from Study 105MS301) up to 4 years|Safety population: all participants who received at least 1 dose of study drug; n=number of participants whose baseline value was not low (or high) and who had at least 1 post-baseline value.||participants|||Number
840151|NCT01332019|Primary|Number of Participants With Shifts From Baseline: Liver Function Laboratory Values|Shift to low includes normal to low, high to low, and unknown to low. Shift to high includes normal to high, low to high, and unknown to high. For participants who switched to alternative MS medications, data after switch and 14 days after last dose of study treatment are excluded. Data collected after Amendment 3 took effect were excluded for participants enrolled into study 105MS302 on every 4 week dosing, but not excluded for participants enrolled on every 2 week dosing. ALT=alanine aminotransferase; AST=aspartate aminotransferase; GGT=gamma-glutamyl transferase.|Baseline (BIIB017 Treatment Baseline from Study 105MS301) up to 4 years|Safety population: all participants who received at least 1 dose of study drug; n=number of participants whose baseline value was not low (or high) and who had at least 1 post-baseline value.||participants|||Number
840152|NCT01332019|Primary|Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities|Data collected after Amendment 3 took effect were excluded for participants enrolled into study 105MS302 on every 4 week dosing, but not excluded for participants enrolled on every 2 week dosing.|up to 4 years|Safety population: all participants who received at least 1 dose of study drug and at least 1 post-baseline value for given parameter.||participants|||Number
840153|NCT01332019|Primary|Number of Participants Experiencing Adverse Events (AEs) Serious AEs, and Discontinuations Due to AEs|AE: any untoward medical occurrence that did not necessarily have a causal relationship with study treatment. SAE: any untoward medical occurrence that at any dose: resulted in death; in the view of the Investigator, placed the participant at immediate risk of death (a life threatening event); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigator, could have jeopardized the participant or may have required intervention to prevent one of the other outcomes listed in the definition above. Data collected after Amendment 3 took effect were excluded for participants enrolled into study 105MS302 on every 4 week dosing, but not excluded for participants enrolled on every 2 week dosing.|up to 4 years|Safety population: all participants who received at least 1 dose of study drug. For participants who switched to alternative MS medications, data after switch and 14 days after last dose of study treatment are excluded.||participants|||Number
840154|NCT01333111|Secondary|Host Cell Proteins (HCP) Antibodies|Subjects who were positive for anti-HCP antibodies.|28 weeks after treatment start on on-demand treatment|Safety analysis set included all subjects exposed to nonacog beta pegol. Subjects in on-demand arm were included for this analysis.||number of subjects|||Number
840155|NCT01333111|Secondary|Host Cell Proteins (HCP) Antibodies|Subjects who were positive for anti-Host Cell Protein (HCP) antibodies.|52 weeks after treatment start for patients on prophylaxis|Safety analysis set included all subjects exposed to nonacog beta pegol. Subjects in prophylaxis arm were included for this analysis.||number of subjects|||Number
840156|NCT01333111|Secondary|Incidence of Serious Adverse Events (SAEs)|SAE was defined as an AE that resulted in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect. The incidence of SAEs were summarised by the rate of SAEs (number of SAEs per PYE). Number of SAEs per PYE is number of SAEs/total time in trial. All SAEs reported are treatment emergent (any serious adverse events which occurred after trial product administration).|at 32 weeks ±2 weeks for patients on on-demand treatment|Safety analysis set included all subjects exposed to nonacog beta pegol. Subjects in on-demand arm were included for this analysis.||number of SAEs per PYE|||Number
840157|NCT01333111|Secondary|Incidence of Serious Adverse Events (SAEs)|SAE was defined as an AE that resulted in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect. The incidence of SAEs were summarised by the rate of SAEs (number of SAEs per PYE). Number of SAEs per PYE is number of SAEs/total time in trial. All SAEs reported are treatment emergent (any serious adverse events which occurred after trial product administration).|at 56 weeks ±2 weeks for patients on prophylaxis|Safety analysis set included all subjects exposed to nonacog beta pegol. Subjects in prophylaxis arm were included for this analysis.||number of SAEs per PYE|||Number
840158|NCT01333111|Secondary|Incidence of Adverse Events (AEs)|The incidence of adverse events were summarised by the rate of AEs (number of AEs per PYE). Number of adverse events per PYE is number of adverse events /total time in trial. All adverse events reported are treatment emergent (any adverse events which occurred after trial product administration).|at 32 weeks ±2 weeks for patients on on-demand treatment|Safety analysis set included all subjects exposed to nonacog beta pegol.Subjects in on-demand arm were included for this analysis.||number of AEs per PYE|||Number
840159|NCT01333111|Secondary|Incidence of Adverse Events (AEs)|The incidence of adverse events were summarised by the rate of AEs (number of AEs per patient years of exposure [PYE]). Number of adverse events per PYE is number of adverse events /total time in trial. All adverse events reported are treatment emergent (any adverse events which occurred after trial product administration).|at 56 weeks ±2 weeks for patients on prophylaxis|Safety analysis set included all subjects exposed to nonacog beta pegol. Subjects in prophylaxis arm were included for this analysis.||number of AEs per PYE|||Number
840160|NCT01333111|Secondary|Factor IX Trough Levels|The mean pre-dose factor IX levels was measured with the one-stage clotting assay during the trial. Lowest factor IX activity recorded during single-dose and steady state, immediately before next dose was given. The analysis was based on a mixed model on the log-transformed plasma factor IX activity with subject as a random effect. The estimated mean factor IX trough level was presented back-transformed to the natural scale.|52 weeks after treatment start for patients on prophylaxis|Full analysis set included all subjects exposed to nonacog beta pegol. Subjects in prophylaxis arm were included for this analysis.||U/mL||95% Confidence Interval|Mean
840161|NCT01333111|Secondary|Number of Bleeding Episodes Per Patient During Routine Prophylaxis|The number of bleeding episodes per patient during routine prophylaxis was assessed using the individual annualised bleeding rates (spontaneous and traumatic bleeding episodes per patient per year).|52 weeks after treatment start for patients on prophylaxis|Full analysis set included all subjects exposed to nonacog beta pegol. Subjects in prophylaxis arm were included for this analysis.||bleeds/patient/year||Inter-Quartile Range|Median
840162|NCT01333111|Secondary|Haemostatic Effect of NNC-0156-0000-0009 When Used for Treatment of Bleeding Episodes, Assessed as Success/Failure Based on a Four-point Scale for Haemostatic Response|"Haemostatic response after treatment of a bleed with nonacog beta pegol was evaluated on a 4 point scale as excellent, good, moderate or poor. A success rate was calculated based on counting good or excellent as successes and poor and moderate as failures.
Excellent – abrupt pain relief and/or clear improvement in objective signs of bleeding within 8 hours after a single injection
Good – noticeable pain relief and/or improvement in signs of bleeding within 8 hours after a single injection
Moderate – probable or slight beneficial effect within the first 8 hours after the first injection but requiring more than one injection within 8 hours
Poor – no improvement, or worsening of symptoms within 8 hours after two injections.
The success rate and 95% confidence interval (CI) are reported here."|28 weeks after treatment start on on-demand treatment|Full analysis set included all subjects exposed to nonacog beta pegol. Subjects in on-demand arm were included for this analysis.||percentage of bleeding episodes||95% Confidence Interval|Number
840163|NCT01333111|Secondary|Haemostatic Effect of NNC-0156-0000-0009 When Used for Prophylaxis of Bleeding Episodes, Assessed as Success/Failure Based on a Four-point Scale for Haemostatic Response|"Haemostatic response after treatment of a bleed with nonacog beta pegol was evaluated on a 4 point scale as excellent, good, moderate or poor. A success rate was calculated based on counting good or excellent as successes and poor and moderate as failures.
Excellent – abrupt pain relief and/or clear improvement in objective signs of bleeding within 8 hours after a single injection
Good – noticeable pain relief and/or improvement in signs of bleeding within 8 hours after a single injection
Moderate – probable or slight beneficial effect within the first 8 hours after the first injection but requiring more than one injection within 8 hours
Poor – no improvement, or worsening of symptoms within 8 hours after two injections.
The success rate and 95% confidence interval (CI) are reported here."|52 weeks after treatment start for patients on prophylaxis|Full analysis set included all subjects exposed to nonacog beta pegol. Subjects in prophylaxis arm were included for this analysis.||percentage of bleeding episodes||95% Confidence Interval|Number
840164|NCT01333111|Primary|Incidence of Inhibitory Antibodies Against Factor IX Defined as Titre Equal to or Above 0.6 BU (Bethesda Units)|Inhibitors were analysed with either the Nijmegen modified factor IX Bethesda assay or a heat/cold Nijmegen modified factor IX Bethesda assay. Number of subjects who developed inhibitory antibodies against factor IX are reported.|28 weeks after treatment start on on-demand treatment|Full analysis set included all subjects exposed to nonacog beta pegol. Subjects in on-demand arm were included for this analysis.||number of subjects|||Number
840165|NCT01333111|Primary|Incidence of Inhibitory Antibodies Against Factor IX Defined as Titre Equal to or Above 0.6 BU (Bethesda Units)|Inhibitors were analysed with either the Nijmegen modified factor IX Bethesda assay or a heat/cold Nijmegen modified factor IX Bethesda assay. Number of subjects who developed inhibitory antibodies against factor IX are reported.|52 weeks after treatment start for patients on prophylaxis|Full analysis set included all subjects exposed to nonacog beta pegol. Subjects in prophylaxis arm were included for this analysis.||Number of subjects|||Number
840166|NCT01333189|Secondary|Hip, Knee, and Ankle Moments During Walking|Internal joint moments at the hip, knee, and ankle were calculated using an inverse dynamics approach from data collected using embedded force plates and a 6-camera motion analysis system to assess reflective marker positions placed at landmarks of the upper limbs, trunk, and lower limbs.|26 weeks post-operative|At the long-term follow up time point (26 weeks post-operative), a total of two patients from each group had dropped out of the study due to time constraints, transportation difficulties, late infection, or moving away from the area.||Newton-meters per kilogram (Nm/kg)||Standard Error|Mean
840167|NCT01333189|Secondary|Walking Speed|Self-selected walking speed was recorded for three passes across the middle 6 meter section of a walkway. The average of the 3 passes is reported.|26 weeks post-operative|At the long-term follow up time point (26 weeks post-operative), a total of two patients from each group had dropped out of the study due to time constraints, transportation difficulties, late infection, or moving away from the area.||meters/second||Standard Deviation|Mean
840249|NCT01334125|Secondary|Baseline Adjusted Changes in Lipid Profile Over Time|Comparison of the baseline-adjusted differences in total cholesterol/high density cholesterol index over time between the metformin and the placebo groups. The reported values represented means adjusted for baseline values, age, gender, and BMI using repeated measures ANOVA (General Linear Model).|Baseline, 3mo, 6mo, and 9 months|||ratio||95% Confidence Interval|Mean
840168|NCT01333189|Secondary|Hip, Knee, and Ankle Joint Moments During Five Times Sit-to-Stand Test|Internal joint moments at the hip, knee, and ankle were calculated using an inverse dynamics approach from data collected using embedded force plates and a 6-camera motion analysis system to assess reflective marker positions placed at landmarks of the upper limbs, trunk, and lower limbs.|26 weeks post-operative|At the long-term follow up time point (26 weeks post-operative), a total of two patients from each group had dropped out of the study due to time constraints, transportation difficulties, late infection, or moving away from the area.||Newton-meters per kilogram (Nm/kg)||Standard Deviation|Mean
840169|NCT01333189|Secondary|Five Times Sit-to-Stand Test (FTSST)|The Five Times Sit-to-Stand Test is quantified as the total time required for an individual to rise from and return to a chair five times in a row.|26 weeks post-operative|At the long-term follow up time point (26 weeks post-operative), a total of two patients from each group had dropped out of the study due to time constraints, transportation difficulties, late infection, or moving away from the area.||seconds||Standard Deviation|Mean
840170|NCT01333189|Secondary|Weight-bearing Ratio During Walking|Weight-bearing ratio is measured during walking as the ratio between lower limbs in peak vertical ground reaction force (vGRF) during the loading response phase of the stance period of gait. Ratios reported are (vGRF of the Surgical Limb):(vGRF Non-Surgical Limb).|26 weeks post-operative|At the long-term follow up time point (26 weeks post-operative), a total of two patients from each group had dropped out of the study due to time constraints, transportation difficulties, late infection, or moving away from the area.||ratio||Standard Deviation|Mean
840171|NCT01333189|Secondary|Weight-bearing Ratio During Five Times Sit-to-Stand Test (FTSST)|Weight-bearing ratio is measured during transitions between sitting and standing and is indicated by symmetry in vertical ground reaction force (vGRF) between lower limbs. Ratios reported are (vGRF of the Surgical Limb):(vGRF Non-Surgical Limb).|26 weeks post-operative|At the long-term follow up time point (26 weeks post-operative), a total of two patients from each group had dropped out of the study due to time constraints, transportation difficulties, late infection, or moving away from the area.||ratio||Standard Deviation|Mean
840172|NCT01333189|Secondary|Hip, Knee, and Ankle Joint Moments During Walking|Internal joint moments at the hip, knee, and ankle were calculated using an inverse dynamics approach from data collected using embedded force plates and a 6-camera motion analysis system to assess reflective marker positions placed at landmarks of the upper limbs, trunk, and lower limbs.|6 weeks post-operative|At the completion of the intervention (6 weeks post-operative), one patient from each group had dropped out of the study due to either time constraints or transportation difficulties.||Newton-meters per kilogram (Nm/kg)||Standard Deviation|Mean
840173|NCT01333189|Secondary|Walking Speed|Self-selected walking speed was recorded for three passes across the middle 6 meter section of a walkway. The average of the 3 passes is reported.|6 weeks post-operative|At the completion of the intervention (6 weeks post-operative), one patient from each group had dropped out of the study due to either time constraints or transportation difficulties.||meters/second||Standard Deviation|Mean
840174|NCT01333189|Secondary|Hip, Knee, and Ankle Joint Moments During Five Times Sit-to-Stand Test|Internal joint moments at the hip, knee, and ankle were calculated using an inverse dynamics approach from data collected using embedded force plates and a 6-camera motion analysis system to assess reflective marker positions placed at landmarks of the upper limbs, trunk, and lower limbs.|6 weeks post-operative|At the completion of the intervention (6 weeks post-operative), one patient from each group had dropped out of the study due to either time constraints or transportation difficulties.||Newton-meters per kilogram (Nm/kg)||Standard Deviation|Mean
840175|NCT01333189|Secondary|Five Times Sit-to-Stand Test (FTSST)|The Five Times Sit-to-Stand Test is quantified as the total time required for an individual to rise from and return to a chair five times in a row.|6 weeks post-operative|At the completion of the intervention (6 weeks post-operative), one patient from each group had dropped out of the study due to either time constraints or transportation difficulties.||seconds||Standard Deviation|Mean
840176|NCT01333189|Secondary|Weight-bearing Ratio During Walking|Weight-bearing ratio is measured during walking as the ratio between lower limbs in peak vertical ground reaction force (vGRF) during the loading response phase of the stance period of gait. Ratios reported are (vGRF of the Surgical Limb):(vGRF Non-Surgical Limb).|6 weeks post-operative|At the completion of the intervention (6 weeks post-operative), one patient from each group had dropped out of the study due to either time constraints or transportation difficulties.||ratio||Standard Deviation|Mean
840177|NCT01333189|Primary|Weight-bearing Ratio During Five Times Sit-to-Stand Test (FTSST)|Weight-bearing ratio is measured during transitions between sitting and standing and is indicated by symmetry in vertical ground reaction force (vGRF) between lower limbs. Ratios reported are (vGRF of the Surgical Limb):(vGRF Non-Surgical Limb).|6 weeks post-operative|At the completion of the intervention (6 weeks post-operative), one patient from each group had dropped out of the study due to either time constraints or transportation difficulties.||ratio||Standard Deviation|Mean
840178|NCT01333397|Secondary|Percentage of Subjects as Responders at Day 29 by the Investigator’s Live Assessment and by Subject’s Self Assessment of Glabellar Lines at Maximum Frown (Assay Sensitivity)||Day 29|ITT Population; N’=number of subjects with an assessment at Day 29||percentage of subjects|||Number
840179|NCT01333397|Secondary|Percentage of Subjects as Responders, as Measured by the Investigator’s Live Assessment at Rest (Comparison With Dysport 50 U)||Days 8, 15, 29, 57, 85 and 113|ITT Population; N’=number of subjects with an Investigator's live assessment of glabellar lines at rest of moderate or severe at Baseline and with an assessment at the given post-Baseline visit||percentage of subjects|||Number
840180|NCT01333397|Secondary|Percentage of Subjects as Responders, as Measured by the Subject’s Self Assessment at Maximum Frown (Comparison With Dysport 50 U)||Days 8, 15, 29, 57, 85 and 113|ITT Population; N’=number of subjects with assessment||percentage of subjects|||Number
840181|NCT01333397|Secondary|Percentage of Subjects as Responders, as Measured by the Investigator’s Live Assessment at Maximum Frown (Comparison With Dysport 50 U)||Days 8, 15, 29, 57, 85 and 113|ITT Population; N’=number of subjects with assessment||percentage of subjects|||Number
840182|NCT01333397|Other Pre-specified|Number of Subjects Reporting at Least One Treatment Emergent Adverse Event During the Study|Treatment Emergent Adverse Event (TEAE)|Up to Day 113 (±3 days)|Safety Population: The safety population included all randomised subjects who received study treatment, regardless of the actual amount injected||participants|||Number
840183|NCT01333397|Secondary|Percentage of Subjects With a Reduction of Two or More Grades in the Severity of Glabellar Lines at Maximum Frown as Measured by the Subject's Self-assessment|A reduction of two or more grades in the severity of glabellar lines at maximum frown was a change from Visit 2 severity of glabellar lines from severe to mild/no wrinkles or from Visit 2 severity of moderate to no wrinkles after treatment as measured by the subjects self assessment.|Days 8, 15, 29, 57, 85 and 113|ITT Population; N’= number of subjects with a subject's self assessment of glabellar lines at maximum frown for the given post-Baseline visit||percentage of subjects|||Number
840184|NCT01333397|Secondary|Percentage of Subjects With a Reduction of Two or More Grades in the Severity of Glabellar Lines at Rest as Measured by the Investigator's Live Assessment|A reduction of two or more grades in the severity of glabellar lines at rest was a change from Visit 2 severity of glabellar lines from severe to mild or from Visit 2 severity of moderate to none after treatment as measured by the Investigator’s live assessment.|Days 8, 15, 29, 57, 85 and 113|ITT Population; N’= number of subjects with an Investigator's live assessment of glabellar lines at rest of moderate or severe at Baseline and with an assessment at the given post-Baseline visit||percentage of subjects|||Number
840185|NCT01333397|Secondary|Percentage of Subjects With a Reduction of Two or More Grades in the Severity of Glabellar Lines at Maximum Frown as Measured by the Investigator's Live Assessment|A reduction of two or more grades in the severity of glabellar lines at maximum frown was a change from Visit 2 severity of glabellar lines from severe to mild/none or from Visit 2 severity of moderate to none after treatment as measured by the Investigator’s live assessment|Days 8, 15, 29, 57, 85 and 113|ITT Population; N’= number of subjects with an Investigator's live assessment of glabellar lines at maximum frown for the given post-Baseline visit||percentage of subjects|||Number
840186|NCT01333397|Secondary|Percentage of Subjects as Responders at Maximum Frown on Day 29 Who Remain Responders|A responder at maximum frown was defined as a subject having a severity grade of none or mild at maximum frown on the visit day and a severity grade of moderate or severe at maximum frown at Visit 2.|Day 113|ITT Population; N’=number of responders at Day 29||percentage of subjects|||Number
840187|NCT01333397|Secondary|Percentage of Subjects as Responders at Rest as Measured by the Investigator's Live Assessment.|A responder at rest was defined as a subject having a severity grade of none or mild at rest on the visit day and a severity grade of moderate or severe at rest at Visit 2.|Days 8, 15, 29, 57, 85 and 113|ITT Population; N’= number of subjects with an Investigator's live assessment of glabellar lines at rest of moderate or severe at Baseline and with an assessment at the given post-Baseline visit;||percentage of subjects|||Number
840188|NCT01333397|Secondary|Percentage of Subjects Assessed as Responders, by Both the Investigator’s Live Assessment and the Subject’s Self-assessment at Maximum Frown.||Days 8, 15, 57, 85 and 113|ITT Population; N’= number of subjects with an Investigator's live assessment and a subject's self assessment of glabellar lines at maximum frown for the given post-Baseline visit||percentage of subjects|||Number
840189|NCT01333397|Secondary|Percentage of Subjects as Responders at Maximum Frown as Measured by the Subject’s Self-assessment.||Days 8, 15, 57, 85 and 113|ITT Population; N’= number of subjects with a subject's self assessment of glabellar lines at maximum frown for the given post-Baseline visit||percentage of subjects|||Number
840190|NCT01333397|Secondary|Percentage of Subjects as Responders at Maximum Frown as Measured by the Investigator’s Live Assessment.||Days 8, 15, 57, 85 and 113|ITT Population; N’=number of subjects with an Investigator's live assessment of glabellar lines at maximum frown for the given post-Baseline visit||percentage of subjects|||Number
840191|NCT01333397|Secondary|Percentage of Subjects as Assessed as Responders, by Both Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown.|A responder at maximum frown was defined as a subject having a severity grade of none or mild at maximum frown on the visit day and a severity grade of moderate or severe at maximum frown at Visit 2.|Day 29|ITT Population; Day 29 (N'=34,36,35,33,35); N’= number of subjects with an Investigator's live assessment and a subject's self assessment of glabellar lines at maximum frown for the given post-Baseline visit||percentage of subjects|||Number
840192|NCT01333397|Primary|Percentage of Subjects as Responders in the ILA (Using Validated 4-point Photographic Scale) and the SSA of Glabellar Lines at Maximum Frown|"Investigator’s live assessment (ILA), subject’s self assessment (SSA), Next Generation (NG)
4-point photographic scale: Investigator's live assessment: None - 0; Mild - 1; Moderate - 2; Severe - 3;
4-point photographic scale: Subject's Self assessment: No wrinkles - 0; Mild wrinkles - 1; Moderate wrinkles - 2; Severe wrinkles - 3;
A responder at maximum frown was defined as a subject having a severity grade of none or mild at maximum frown on Day 29 and a severity grade of moderate or severe at maximum frown at Visit 2."|Day 29|Intent-to-Treat Population: The intent-to-treat (ITT) population included all randomised subjects who received study treatment, regardless of the actual amount injected. N’=number of subjects with assessment||percentage of subjects|||Number
840193|NCT01333436|Secondary|Fasting ApoB-48 Levels|ApoB-48 levels measured after at least a 12-hour fast and prior to administration of test meal (Hour 0).|Baseline (Hour 0)|Full-Analysis-Set (FAS) population defined as all participants who had valid postprandial ApoB-48 measurements for all specified time points to calculate iAUC.||μg/mL||Standard Deviation|Mean
840194|NCT01333436|Secondary|Postprandial Mean ApoB-48 Peak Levels|ApoB-48 levels measured at 1, 2, 3, 4, and 6 hours after the administration of test meal. Peak was the highest ApoB-48 level recorded during this timeframe.|up to 6 hours after Test Meal|Full-Analysis-Set (FAS) population defined as all participants who had valid postprandial ApoB-48 measurements for all specified time points to calculate iAUC.||μg/mL||Standard Deviation|Mean
840195|NCT01333436|Primary|Postprandial Incremental Area Under the Curve From 0-6 Hours (iAUC)[0-6] of Apolipoprotein B-48 (ApoB-48)|ApoB-48 levels were measured at 1, 2, 3, 4, and 6 hours after the administration of the test meal.|up to 6 hours after Test Meal|Full-Analysis-Set (FAS) population defined as all participants who had valid postprandial ApoB-48 measurements for all specified time points to calculate iAUC.||μg/mL x h||Standard Deviation|Mean
840196|NCT01333475|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events, see the adverse event module.|29 months, 23 days|||participants|||Number
840372|NCT01335477|Secondary|Absolute Change From Baseline in Forced Vital Capacity (FVC) Over 52 Weeks|Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52).|Baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)||mL||Standard Error|Mean
840197|NCT01333475|Primary|pERK and pAKT Levels in Tumor Biopsies on C1D1 and C1D22 Post-administration of the Combination of AZD6244 Hydrogen Sulfate and MK-2206 in Participants With Advanced Colorectal Cancer|A predetermined target inhibition reduction of 70% of both pERK and pAKT was deemed significant, thus tumor biopsies were performed at C1D1 or C1D22 post administration and evaluated using quantitative chemiluminescence immunoassay to measure pERK and pAKT levels in human tissue.|C1D1 and C1D22 post administration of the combination of AZD6244 hydrogen sulfate and MK-2206|||pg/ µg of protein||Full Range|Mean
840198|NCT01333488|Secondary|Vasospasm|as measured by TCD (Transcranial Doppler)|up to 3 months|||Percentage of participants|||Number
840199|NCT01333488|Secondary|GOS|GOS score|12 months after injury|||GOS score||Full Range|Mean
840200|NCT01333488|Primary|GOS (Glasgow Outcome Score)|"GOS=5 (Good Recovery) - Capacity to resume normal occupational and social activities, although some there may be some minor physical or mental deficits or symptoms.
GOS=4 (Moderate Disability) - Independent and can resume almost all activities of daily living.
GOS=3 (Severe Disability) - No longer capable of engaging in most previous personal, social or work activities. Typically are partially or totally dependent on assistance from others in daily living.
GOS=2 ( Persistent Vegetative State ) GOS=1 (Dead)"|Discharge from Hospital - Within 2 months from Injury|||units on a scale||Full Range|Mean
840201|NCT01333501|Secondary|Changes in the Environmental Status Scale Score (ESS)|The Environmental Status Scale (ESS) is used to quickly evaluate a patient for handicap. It was derived from a measure of socio-economic status. It consists of seven parameters: (1) actual work status, (2) financial and economic status, (3) personal residence or home, (4) personal assistance required, (5) transportation, (6) community services, (7) social activity. Each parameter has a single score from minimum 0 to maximum 5. ESS score is the sum of the points for all 7 parameters: minimum score: 0; maximum score: 35. The higher the score the greater the handicap|Baseline, 18 month|Full analysis set (FAS) - all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of both primary efficacy variables (i.e. non-missing information about the BRB and DKEFS – Sorting test) without any major protocol violations||Score||Standard Deviation|Mean
840202|NCT01333501|Secondary|Change From Screening in the Percentage of Brain Volume Change|Calculations of brain volume change were performed using the structural image evaluation of normalized atrophy (SIENA), software included in the Functional Magnetic Resonance Imaging of the Brain (FMRIB) software library. SIENA is a fully automated method for estimating temporal brain volume change.|Screening (-1month), 18 month|Full analysis set (FAS) - all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of both primary efficacy variables (i.e. non-missing information about the BRB and DKEFS – Sorting test) without any major protocol violations||percentage of brain volume||Standard Deviation|Mean
840203|NCT01333501|Secondary|Change From Screening in the Number of T1 Gd+ Enhancing Lesions|Total number of post-baseline Gd-enhanced lesions is calculated as a sum of all Gd-enhanced lesions seen on post-baseline scans per visit. Real (not per slice) lesions are counted in this analysis|Screening (-1month), 18 month|Full analysis set (FAS) - all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of both primary efficacy variables (i.e. non-missing information about the BRB and DKEFS – Sorting test) without any major protocol violations||Number of new lesions||Standard Deviation|Mean
840204|NCT01333501|Secondary|Change From Screening in the Volume of Total T1 Hypointense Lesions|Volume of hypointense post-gadolinium T1 lesion component was measured by MRI scan. Means were estimated using a Mixed-effect model with repeated measures (MMRM) by-visit interaction.|Screening (-1month), 18 month|Full analysis set (FAS) - all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of both primary efficacy variables (i.e. non-missing information about the BRB and DKEFS – Sorting test) without any major protocol violations||mm^3||Standard Deviation|Mean
840205|NCT01333501|Secondary|Change From Screening in the Number of New T2 Lesions|New T2 lesions at a specific visit were assessed relative to the previous visit scan. The total number of lesions (visit 8 to 18 month) is calculated as the sum of the number of lesions.|Screening (-1month), 18 month|Full analysis set (FAS) - all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of both primary efficacy variables (i.e. non-missing information about the BRB and DKEFS – Sorting test) without any major protocol violations||Number of new lesions||Standard Deviation|Mean
840206|NCT01333501|Secondary|Changes From Baseline in Fatigue Impact Scale (mFIS, Total Score and Scores of the 3 Individual Domains).|Modified Fatigue Impact Scale (mFIS) questionnaire is described at each time point to evaluate fatigue by means of usual descriptive statistics. Three domains were also defined: Physical Subscale (sum of items 4, 6, 7, 10, 13, 14, 17, 20, 21 and therefore ranging from 0 to 36), Cognitive Subscale (sum of items 1, 2, 3, 5, 11, 12, 15, 16, 18, 19 and therefore ranging from 0 to 40) and Psychosocial Subscale (sum of items 8, 9 and therefore ranging from 0 to 8). Finally, mFIS - overall score ranged from 0 to 80. The mFIS total score was computed as the sum of scores for each item. Lower values represent a better outcome.|Baseline, 18 months|Full analysis set (FAS) - all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of both primary efficacy variables (i.e. non-missing information about the BRB and DKEFS – Sorting test) without any major protocol violations||Score||Standard Error|Least Squares Mean
840207|NCT01333501|Secondary|Changes in Quality of Life, by Means of the Multiple Sclerosis Quality of Life (MSQoL-54)|A 54 question measure covers 12 domains; assesses mental and physical health. The physical health composite score is a weighted average of the physical health scales, such as physical function, health perceptions, and energy. The mental health composite score is a weighted average of the mental health scales, such as overall quality of life, cognitive function, and health distress. Each domain has a range from 0 to 100 where higher means better.|Baseline, 18 months|Full analysis set (FAS) - all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of both primary efficacy variables (i.e. non-missing information about the BRB and DKEFS – Sorting test) without any major protocol violations||Score||Standard Error|Least Squares Mean
840245|NCT01333956|Secondary|Opioid-Related Symptom Distress Score|Opioid-Related Symptom Distress score (ORSDS) measured at POD1 and POD14. The ORSDS is a 4-point scale that evaluates 3 symptom distress dimensions (frequency, severity, bothersomeness) for 12 symptoms. The symptom-specific ORSDS is the average of the 3 symptom distress dimensions. The composite ORSDS is the average of 12 symptom-specific scores. (0=low; 4=high).|2 weeks postoperatively|||units on a scale||Inter-Quartile Range|Median
840208|NCT01333501|Secondary|Change From Screening in Montgomery-Asberg Depression Rating Scale (MADRS)|MADRS measures the overall severity of depressive symptoms. The MADRS had a 10-item checklist. Items are rated on a scale of 0-6, for a total numeric range of scores from 0 (depressive symptoms absent) to 60 (numerically highest level of depressive symptoms).|Screening (-1month), 18 month|Full analysis set (FAS) - all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of both primary efficacy variables (i.e. non-missing information about the BRB and DKEFS – Sorting test) without any major protocol violations||Raw score||Standard Error|Least Squares Mean
840209|NCT01333501|Secondary|Change From Screening in the Volume of Total T2 Lesions|Change in volume of total T2-weighted lesions by visit were summarized. Negative values indicate improvement (reduction in lesion volume) and positive values worsening (increase in lesion volume|Screening (-1 month), 18 months|||mm^3||Standard Deviation|Mean
840210|NCT01333501|Primary|Change From Screening in DKEFS Condition 2: Sort Recognition, Sort Recognition Description Score- Card Set 1+2|The Delis-Kaplan Executive Function System – Sorting Test is one of the nine tests presented in the DKEFS manual and explores the patient’s executive abilities. It has a standard form (version A, administered at screening and Month-18 visit) and an alternate form (version B, administered at Month-9 visit). The standard form consists of the practice card set, card set 1 and card set 2. The alternate form consists of the same practice card set, card set 3 and card set 4. Free sorting and sort recognition. In free sorting, six scores were obtained: Confirmed Correct sorts for card sets 1 and 2 (or 3 and 4 for version B), sum of confirmed Correct Sorts, Free Sorting Description score for card set 1 and 2 (or 3 and 4 for version B) and sum of Free Sorting Description scores. The total score ranged from 0 to 64. Higher values represent a better outcome.|Screening (-1month), 18 month|Full analysis set (FAS) - all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of both primary efficacy variables (i.e. non-missing information about the BRB and DKEFS – Sorting test) without any major protocol violations||Raw score||Standard Error|Least Squares Mean
840211|NCT01333501|Primary|Change From Screening in DKEFS Condition 1: Free Sorting, Free Sorting, Description Score, Card Set 1+2|The Delis-Kaplan Executive Function System – Sorting Test is one of the nine tests presented in the DKEFS manual and explores the patient’s executive abilities. It has a standard form (version A, administered at screening and Month-18 visit) and an alternate form (version B, administered at Month-9 visit). The standard form consists of the practice card set, card set 1 and card set 2. The alternate form consists of the same practice card set, card set 3 and card set 4. In free sorting, six scores were obtained: Confirmed Correct sorts for card sets 1 and 2 (or 3 and 4 for version B), sum of confirmed Correct Sorts, Free Sorting Description score for card set 1 and 2 (or 3 and 4 for version B) and sum of Free Sorting Description scores. In sort recognition, a description score for card set 1 and 2 (or 3 and 4 for version B) was obtained, as well as the sum of description scores of both sets. The total score ranged from 0 to 64. Higher values represent a better outcome|Screening (-1month), 18 month|Full analysis set (FAS) - all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of both primary efficacy variables (i.e. non-missing information about the BRB and DKEFS – Sorting test) without any major protocol violations||Raw score||Standard Error|Least Squares Mean
840212|NCT01333501|Primary|Change From Screening in Delis-Kaplan Executive Function System (DKEFS) Condition 1: Free Sorting, Confirmed Correct Sort- Card Set 1+2|The Delis-Kaplan Executive Function System – Sorting Test is one of the nine tests presented in the DKEFS manual and explores the patient’s executive abilities. It has a standard form (version A, administered at screening and Month-18 visit) and an alternate form (version B, administered at Month-9 visit). The standard form consists of the practice card set, card set 1 and card set 2. The alternate form consists of the same practice card set, card set 3 and card set 4. The DKFES test consisted of two testing procedures: free sorting and sort recognition. In free sorting, six scores were obtained: Confirmed Correct sorts for card sets 1 and 2 (or 3 and 4 for version B), sum of confirmed Correct Sorts. In sort recognition, a description score for card set 1 and 2 (or 3 and 4 for version B) was obtained, as well as the sum of description scores of both sets. The total score ranged from 0 to 16. Higher values represent a better outcome|Screening (-1month), 18 month|Full analysis set (FAS) - all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of both primary efficacy variables (i.e. non-missing information about the BRB and DKEFS – Sorting test) without any major protocol violations||Raw score||Standard Error|Least Squares Mean
840213|NCT01333501|Primary|Change From Screening in Word List Generation (WLG)|Word List Generation (COWAT/WLG): The COWAT assesses verbal fluency on semantic stimulus by asking the patient to produce as many words as possible belonging to a semantic category. The test assessed the verbal fluency, recorded all the possible correct word that a patients should give in 90 sec. No maximum range is available. Higher values represent a better outcome. The score was the number of correct words. The more words the patient pronounces, the better it is. We can imagine that the minimum value might be zero words, , but it is not a score scale.|Screening (-1month), 18 month|Full analysis set (FAS) - all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of both primary efficacy variables (i.e. non-missing information about the BRB and DKEFS – Sorting test) without any major protocol violations||Raw score||Standard Error|Least Squares Mean
840214|NCT01333501|Primary|Change From Screening in Spatial Recall Test – Delayed Recall (SPART-D)|Spatial Recall Test (SPART) for visuospatial learning and delayed recall.Spatial Recall Test (10/36): The spatial recall test assesses visuospatial learning and delayed recall (10/36-D). A checkerboard with ten checkers arranged in a pattern was shown to the subject for ten seconds. The subject was then asked to reproduce the same pattern with ten checkers on an empty checkerboard. The test includes three consecutive trials. The score was the total number of correct responses for the tree trials. The total score ranged from 0 to 10. Higher values represent a better outcome.|Screening (-1month), 18 month|Full analysis set (FAS) - all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of both primary efficacy variables (i.e. non-missing information about the BRB and DKEFS – Sorting test) without any major protocol violations||Raw score||Standard Error|Least Squares Mean
840246|NCT01333956|Primary|Postoperative Pain|Pain assessment scale (Numeric Rating Scale) (0=no pain; 10=worst pain imaginable).|2 weeks postoperatively|||units on a scale||Standard Deviation|Mean
840215|NCT01333501|Primary|Change From Screening in Selective Reminding Test – Delayed Recall (SRT-D) Raw Score|The tests SRT (Selective Reminding Test) for episodic memory (verbal learning and delayed recall). The Delayed SRT test is the total number of words recalled after a delayed period. The total score ranged from 0 to 12. Higher values represent a better outcome.|Screening (-1month), 18 month|Full analysis set (FAS) - all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of both primary efficacy variables (i.e. non-missing information about the BRB and DKEFS – Sorting test) without any major protocol violations||Raw score||Standard Error|Least Squares Mean
840216|NCT01333501|Primary|Change From Screening in Paced Auditory Serial Addition Test – 2 (PASAT 2) Raw Score|Paced Auditory Serial Addition Test (PASAT) for working memory (and sustained attention and information processing speed). The patient hears a series of numbers from recordings that are presented at the rate of one every 2 seconds in the second part of the test (PASAT-2). The patient was asked to add each consecutive digit to the one immediately preceding it. Sixty-one digits are presented for each part, and each part has a maximum of 60 correct answers. The total score ranged from 0 to 60. Higher values represent a better outcome.|Screening (-1month), 18 month|Full analysis set (FAS) - all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of both primary efficacy variables (i.e. non-missing information about the BRB and DKEFS – Sorting test) without any major protocol violations||Raw score||Standard Error|Least Squares Mean
840217|NCT01333501|Primary|Change From Screening in Paced Auditory Serial Addition Test – 3 Seconds (PASAT 3) Raw Score|Paced Auditory Serial Addition Test (PASAT) for working memory (and sustained attention and information processing speed). The patient hears a series of numbers from recordings that are presented at the rate of one every 3 seconds in the first part of the test (PASAT-3). The patient is asked to add each consecutive digit to the one immediately preceding it. Sixty-one digits are presented for each part, and each part has a maximum of 60 correct answers. The total score ranged from 0 to 60. Higher values represent a better outcome.|Screening (-1month), 18 month|Full analysis set (FAS) - all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of both primary efficacy variables (i.e. non-missing information about the BRB and DKEFS – Sorting test) without any major protocol violations||Raw score||Standard Error|Least Squares Mean
840218|NCT01333501|Primary|Change From Screening in Symbol Digit Modalities Test (SDMT) Raw Score|Symbol Digit Modality Test (SDMT) for sustained attention and information processing speed. It presents a series of nine symbols, each of which is paired with a single digit labeled 1-9 in a key at the top of the sheet. The reminder of the page has a pseudo-randomized sequence of symbols, and the patient must respond with the digit associated with each of these as quickly as possible. The score is the number of correct answers in 90 seconds. The total score ranged from 0 to 110. Higher values represent a better outcome.|Screening (-1month), 18 month|Full analysis set (FAS) - all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of both primary efficacy variables (i.e. non-missing information about the BRB and DKEFS – Sorting test) without any major protocol violations||Raw score||Standard Error|Least Squares Mean
840219|NCT01333501|Primary|Change From Screening in Spatial Recall Test (SPART) Raw Score|Spatial Recall Test (SPART) for visuospatial learning and delayed recall.Spatial Recall Test (10/36): The spatial recall test assesses visuospatial learning and delayed recall (10/36-D). A checkerboard with ten checkers arranged in a pattern is shown to the subject for ten seconds. The subject is then asked to reproduce the same pattern with ten checkers on an empty checkerboard. The test includes three consecutive trials. The score is the total number of correct responses for the tree trials. The total score ranged from 0 to 30. Higher values represent a better outcome.|Screening (-1month), 18 month|Full analysis set (FAS) - all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of both primary efficacy variables (i.e. non-missing information about the BRB and DKEFS – Sorting test) without any major protocol violations||Raw score||Standard Error|Least Squares Mean
840220|NCT01333501|Primary|Change From Screening in Selective Reminding Test – Consistent Long Term Retrieval (SRT-CLTR) Raw Score|Brief Repeatable Battery (BRB)- widely used as a clinical and research tool, with 68% sensitivity and 85% specificity. It consists of the serial administration of 5 tests. One of the tests is SRT (Selective Reminding Test) for episodic memory (verbal learning and delayed recall). A word recalled on two consecutive trials is considered to have entered long-term storage (LTS) on the first of these trials and scored as LTS on all following trials. The total of the words in LTS of all six trials is then summed. If a word in LTS is consistently recalled on all subsequent trials, it is then scored as Consistent Long Term Retrieval (CLTR). The total of the words in CLTR of all six trials is summed. The total score ranged from 0 to 72. Higher values represent a better outcome.|Screening (-1month), 18 month|Full analysis set (FAS) - all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of both primary efficacy variables (i.e. non-missing information about the BRB and DKEFS – Sorting test) without any major protocol violations.||Raw score||Standard Error|Least Squares Mean
840221|NCT01333501|Primary|Change From Screening in Selective Reminding Test – Long-Term Storage (SRT-LTS) Raw Score|Brief Repeatable Battery (BRB)- widely used as a clinical and research tool, with 68% sensitivity and 85% specificity. It consists of the serial administration of 5 tests. One of the tests is SRT (Selective Reminding Test) for episodic memory (verbal learning and delayed recall). A word recalled on two consecutive trials is considered to have entered long-term storage (LTS) on the first of these trials and scored as LTS on all following trials. The total of the words in LTS of all six trials is then summed. The total score ranged from 0 to 72. Higher values represent a better outcome.|Screening (-1month), 18 month|Full analysis set (FAS) - all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of both primary efficacy variables (i.e. non-missing information about the BRB and DKEFS – Sorting test) without any major protocol violations.||raw score||Standard Error|Least Squares Mean
840222|NCT01333592|Primary|Incidences of Adverse Events||52 weeks|||Participants|||Number
840223|NCT01333592|Secondary|Change From Baseline in HbA1c at 52 Weeks||at week 0 and week 52|||percentage of HbA1c||Standard Deviation|Mean
840224|NCT01333722|Secondary|Time to Perceptible and Meaningful Pain Relief|The median time (minutes) from first perceptible pain relief (onset of pain relief) and time until first meaningful pain relief.|From time of first study drug administration to 12 hours following first study drug administration|All randomized participants who received at least 1 dose of study drug.||minutes||95% Confidence Interval|Median
840225|NCT01333722|Secondary|SPRID (Pain Relief and Pain Intensity Difference)|"SPRID was defined as the sum of Pain Relief score (TOTPAR, See Outcome Measure 2 for details*) plus the Pain Intensity Difference (SPID) Categorical score, where participants assessed pain intensity on a Categorical Pain Intensity Scale by answering the following question: My pain at this time is… with one of the following responses: no pain or none, mild pain, moderate pain, or severe pain). Higher mean SPRID scores indicated better pain control. The SPRID score is a measure of the cumulative pain intensity difference during treatment and the area under the curve was estimated using the linear trapezoidal rule."|From time of first study drug administration to 12 hours following first study drug administration|All randomized participants who received at least 1 dose of study drug.||scores on a scale||Standard Error|Least Squares Mean
840226|NCT01333722|Secondary|TOTPAR (Total Pain Relief)|TOTPAR was the time-interval weighted sum of pain relief. Pain relief was assessed by participants’ responses to how their pain relief was compared with the pain they had just before receiving the first dose of study drug: no relief, a little relief, some relief, a lot of relief, or complete relief. Higher mean TOTPAR scores indicate better pain relief. The TOTPAR score is a measure of the cumulative pain intensity difference during treatment and the area under the curve was estimated using the linear trapezoidal rule.|From time of first study drug administration to 12 hours following first study drug administration|All randomized participants who received at least 1 dose of study drug.||scores on a scale||Standard Error|Least Squares Mean
840227|NCT01333722|Primary|Sum of Pain Intensity Difference (SPID) Using the Pain Intensity Visual Analog Scale (VAS)|"Participants assessed pain intensity on a 100 mm visual analogue scale (VAS) with 0 meaning no pain and 100 meaning the worst pain imaginable. The SPID VAS score for 0 to 12 hours following initial study drug dose measured the cumulative pain intensity difference during treatment with higher mean SPID VAS scores indicating greater improvement from Baseline. The SPID score is a measure of the cumulative pain intensity difference during treatment and the area under the curve was estimated using the linear trapezoidal rule."|From time of first study drug administration to 12 hours following first study drug administration|All randomized participants who received at least 1 dose of study drug.||scores on a scale||Standard Error|Least Squares Mean
840228|NCT01333813|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination.|After the challenge dose of Engerix-B Kinder vaccine up to the study end (Day 0 to Month 1)|Analysis was performed on Total Vaccinated cohort which included all subjects who received the challenge dose of Engerix-B Kinder vaccine.||subjects|||Number
840229|NCT01333813|Secondary|Number of Subjects Reporting Any Unsolicited AEs|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 31-day (Day 0-30) follow-up period after the challenge dose of Engerix-B Kinder vaccine|Analysis was performed on Total Vaccinated cohort which included all subjects who received the challenge dose of Engerix-B Kinder vaccine.||subjects|||Number
840230|NCT01333813|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs|"Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache and temeperature.
Any temperature was defined as axillary temperature ≥ 37.5 degree centigrade (°C), grade 3 temperature was axillary temperature > 39.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relation to vaccination and grade 3 was defined as a general symptom that prevented normal activity. Related was a general symptom assessed by the investigator as causally related to the study vaccination."|During the 4-day (Day 0-3) follow-up period after the challenge dose of Engerix-B Kinder vaccine|Analysis was performed on Total Vaccinated cohort which included all subjects who received the challenge dose of Engerix-B Kinder vaccine.||subjects|||Number
840231|NCT01333813|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)|Solicited local symptoms assessed were pain, redness and swelling. Any was occurrence of any local symptom regardless of their intensity grade. Grade 3 pain was considerable pain at rest that prevented normal everyday activities. Grade 3 redness and swelling was > 50 millimeter (mm).|During the 4-day (Day 0-3) follow-up period after the challenge dose of Engerix-B Kinder vaccine|Analysis was performed on Total Vaccinated cohort which included all subjects who received the challenge dose of Engerix-B Kinder vaccine .||subjects|||Number
840232|NCT01333813|Secondary|Number of Subjects Demonstrating an Anamnestic Response to the Engerix-B Kinder Challenge Dose|The anamnestic response is defined as an antibody concentration ≥ 10 mIU/mL at post Engerix-B Kinder challenge dose time point for initially seronegative subjects ,and as an antibody concentration at post Engerix-B Kinder challenge dose time point ≥ 4 fold the pre-vaccination antibody concentration for initially seropositive subjects. A seropositive/seronegative subject was defined as subject with HBs antibody concentration below/greater than or equal to the seropositivity cut-off of 6.2 mIU/mL. A decrease in the specificity of the anti-HBs ELISA had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis and the initial 3.3 mIU/mL seropositivity cut-off was revised into the new 6.2 mIU/mL cut-off.|After Engerix-B Kinder challenge dose (Month 1)|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who had received a challenge dose of Engerix-B Kinder vaccine and for whom immunogenicity data were available at the post- Engerix-B Kinder challenge time point.||subjects|||Number
840247|NCT01334125|Secondary|Number of Participants With Minor, Major, and Nocturnal Hypoglycemia|Comparison of the occurrence of hypoglycemic event requiring a third party assistance (major hypoglycemia) per subject during the study, and minor hypoglycemia (plasma glucose of <60 mg/dL or no measurement), as well as nocturnal hypoglycemia (plasma glucose of ≤60 mg/dL between 11PM and 6AM).|12 months|||participants|||Number
840385|NCT01328756|Primary|Change From Baseline in Body Mass Index (BMI) at Last On-treatment Assessment (LOTA)|BMI was calculated as (weight [kilogram] per height [square meter]).|Baseline (Week 0), LOTA (Week 104)|Safety population with participants evaluable for this outcome||kilogram per square meter||Standard Deviation|Mean
840233|NCT01333813|Secondary|Anti-HBs Antibody Concentrations|Antibody concentrations are expressed as Geometric mean antibody concentrations (GMCs) in mIU/mL. A decrease in the specificity of the anti-HBs had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi-Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis.|One month (Month 1) after a challenge dose of Engerix-B Kinder vaccine|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who had received a challenge dose of Engerix-B Kinder vaccine and for whom immunogenicity data were available at the post- Engerix-B Kinder challenge time point.||mIU/mL||95% Confidence Interval|Geometric Mean
840234|NCT01333813|Secondary|Number of Subjects With Anti-HBs Antibody Concentrations Equal to or Above Protocol Specified Cut-off Values|Anti-HBs antibody concentrations cut-off values assessed were ≥ 6.2 mIU/mL (previously 3.3 mIU/mL) and ≥ 10 mIU/mL. A decrease in the specificity of the anti-HBs ELISA had been observed in some studies for low levels of anti-HBs antibodies (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi-Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis and the initial 3.3 mIU/mL seropositivity cut-off was revised into the new 6.2 mIU/mL cut-off.|One month (Month 1) after a challenge dose of Engerix-B Kinder vaccine|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who had received a challenge dose of Engerix-B Kinder vaccine and for whom immunogenicity data were available at the post- Engerix-B Kinder challenge time point.||subjects|||Number
840235|NCT01333813|Secondary|Number of Subjects With Anti-HBs Antibody Concentrations Equal to or Above the Protocol Specified Cut-off Values After Previous Vaccination With Infanrix Hexa Vaccine|Anti-HBs antibody concentrations cut-off values assessed were ≥ 6.2 mIU/mL (previously 3.3 mIU/mL), ≥ 10 mIU/mL, ≥ 10 mIU/mL to <100 mIU/mL and ≥ 100 mIU/mL. A decrease in the specificity of the anti-HBs ELISA had been observed in some studies for low levels of anti-HBs antibodies (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi-Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis and the initial 3.3 mIU/mL seropositivity cut-off was revised into the new 6.2 mIU/mL cut-off.|Before (Day 0) a challenge dose of Engerix-B Kinder vaccine|Analysis was performed on According-to-Protocol (ATP) cohort for persistence which included all subjects previously primed and boosted with 4 doses of Infanrix hexa in the first 2 years of life; with no evidence of hepatitis B infection or disease and for whom serological results were available at the pre- Engerix-B Kinder challenge time point.||subjects|||Number
840236|NCT01333813|Secondary|Anti-HBs Antibody Concentrations After Previous Vaccination With Infanrix Hexa Vaccine.|"Antibody concentrations are expressed as Geometric mean antibody concentrations (GMCs) in mIU/mL.
A decrease in the specificity of the anti-HBs ELISA had been observed in some studies for low levels of anti-HBs antibodies (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi-Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis."|Before (Day 0) a challenge dose of Engerix-B Kinder vaccine|Analysis was performed on According-to-Protocol (ATP) cohort for persistence which included all subjects previously primed and boosted with 4 doses of Infanrix hexa in the first 2 years of life; with no evidence of hepatitis B infection or disease and for whom serological results were available at the pre- Engerix-B Kinder challenge time point.||mIU/mL||95% Confidence Interval|Geometric Mean
840237|NCT01333813|Primary|Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 100 Milli-International Units Per Milliliter (mIU/mL)|A decrease in the specificity of the anti-HBs enzyme-linked immunosorbent assay (ELISA) had been observed in some studies for low levels of anti-HBs antibodies (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi-Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis.|One month (Month 1) after a challenge dose of Engerix-B Kinder vaccine|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who had received a challenge dose of Engerix-B Kinder vaccine and for whom immunogenicity data were available at the post- Engerix-B Kinder challenge time point.||subjects|||Number
840238|NCT01333865|Secondary|Number of Participants With Reduction in ASD Symptom Severity as Defined by the NIMH Clinical Global Impression for Pervasive Developmental Disorders (CGI-PDD) Improvement Score|Number of participants with reduction in ASD symptom severity defined as an NIMH Clinical Global Impression (CGI) Pervasive Developmental Disorder (PDD) Improvement score less than or equal to 2. The CGI-Improvement is a clinician-rated measure of improvement. Scores range from 1 (very much improved) to 7 (very much worse) for PDD.|Pre-treatment - 12 weeks|19 participants were exposed to the medication, but 1 withdrew due to feeling mildly sedated which affected his driving. This occurred too early in the study for him to be analyzed.||participants|||Number
840239|NCT01333865|Primary|Number of Participants With Reduction in ASD Symptom Severity as Defined by the Social Responsiveness Scale (SRS)|"Number of participants with reduction in ASD symptom severity defined as a reduction in Social Responsiveness Scale (SRS) score from baseline of greater than or equal to 30%.
The SRS is a 65-item rating scale completed by an informant to measure the severity of autism spectrum symptoms as they occur in natural settings."|Week 12|19 participants were exposed to the medication, but 1 withdrew due to feeling mildly sedated which affected his driving. This occurred too early in the study for him to be analyzed.||participants|||Number
840240|NCT01333956|Secondary|Satisfaction|Satisfaction with pain management (1-10 scale; 1 = very dissatisfied, 10 = very satisfied)|2 weeks|||units on a scale||Inter-Quartile Range|Median
840241|NCT01333956|Secondary|Opioid Usage|Opioid Usage (POD1, POD 3, 2 weeks, 3 months)|3 months|||mg||95% Confidence Interval|Mean
840242|NCT01333956|Secondary|Neuropathic Pain|Neuropathic pain incidence: Leeds assessment of neuropathic symptoms and signs (LANSS) score (3 months). Scale of 0 to 24. Higher values represent worse outcomes.|3 months|||units on a scale||Inter-Quartile Range|Median
840243|NCT01333956|Secondary|Numeric Rating Scale (NRS)|NRS Pain (pre-operative, POD1, POD3, 2 weeks, 3 months, at orthopedic visits). Neuropathic pain incidence: Leeds assessment of neuropathic symptoms and signs (LANSS) score (3 months)|3 months|||units on a scale||95% Confidence Interval|Mean
840250|NCT01334125|Primary|Baseline Adjusted Hemoglobin A1c Over Time|Comparison of the baseline-adjusted differences in HbA1c between the metformin and placebo groups during the trial. Hemoglobin A1c is a marker of glycemic control. The reported values represented means adjusted for baseline values, age, gender, and BMI using repeated measures ANOVA (General Linear Model).|Baseline, 3mo, 6mo, and 9 months|||percentage of HbA1c||95% Confidence Interval|Mean
840251|NCT01334216|Primary|Parental Smoking Quit Rate|This is the number of participants who quit smoking|one year|||Participants|||Count of Participants
840252|NCT01334229|Secondary|Measurement of Apolipoprotein B48 and Apolipoprotein B100 Fractional Catabolic Rates With Stable Isotope During Postprandial Period||6 weeks|||pools/day||Standard Deviation|Mean
840253|NCT01334229|Secondary|Measurement of Apolipoprotein B48 and Apolipoprotein B100 Pool Sizes With Stable Isotope During Postprandial Period||6 weeks|||mg||Standard Deviation|Mean
840254|NCT01334229|Secondary|Measurement of Insulin||6 weeks|||pmol/L||Standard Deviation|Mean
840255|NCT01334229|Secondary|Measurement of Glucose||6 weeks|||mmol/L||Standard Deviation|Mean
840256|NCT01334229|Secondary|Measurement of Glucagon-like Peptide-1 by ELISA||6 weeks|||pmol/L||Standard Deviation|Mean
840257|NCT01334229|Primary|Measurement of Apolipoprotein B48 and Apolipoprotein B100 Production Rates With Stable Isotope During Postprandial Period||6 weeks|||mg/kg/day||Standard Deviation|Mean
840258|NCT01334515|Secondary|Overall Response Evaluated in This Study Using the New International Criteria Proposed by the Revised Response Evaluation Criteria in Solid Tumors (RECIST)|Number of patients where best overall response is a complete response (CR)-[disappearance of all target lesions and disappearance of any other measureable disease], a very Good Partial Response (VGPR)- [>90% decrease of the disease measurement for CT/MRI lesions, taking as reference the disease measurement done to confirm measurable disease at study entry. Non-target CT/MRI lesions stable to smaller in size], or partial Response (PR)- [>= 30% decrease in the disease measurement, taking as reference the disease measurement done to confirm measurable disease at study entry. Non-target CT/MRI lesions stable to smaller in size], and maintains the response. It is possible that a subject’s response to therapy may not occur until after several months of treatment. In order to prevent bias, the maximum duration of time/treatment over which a subject’s response is to be assessed for determination of the best overall response is after the completion of up to 10 courses.|Every two cycles (each cycle lasts 28 days)|Patients will be evaluable for inclusion in the analysis of response if they have an event at any time on the study or if they complete at least 2 cycles of hu14.18-IL2 therapy. Patients who go off-protocol therapy prior to the completion of 2 cycles due to parent/family choice and/or due to toxicity will not be considered evaluable for response.||participants|||Number
840259|NCT01334515|Primary|Number of Patients With Unacceptable Dose Limiting Toxicities (DLTs)|Test for tolerability and monitor for the occurrence of too many unacceptable DLTs using a two-stage stopping rule: (Stage 1) Accrue 10 patients. If more than 1 experience at least one unacceptable DLT during the first treatment cycle, the regimen will be considered to have unacceptable toxicity, and accrual will be temporarily closed, to review all relevant data and consider modifying the regimen to improve safety. If 1 or no patients have an unacceptable DLT in the first treatment cycle, then continue. (Stage 2) Accrue 20 more patients. If 7 or more experience at least one unacceptable DLT in the first treatment cycle, temporarily close the study for possible dosing-safety modifications. If 6 or fewer have an unacceptable DLT in the first treatment cycle, it is reasonable to assume that the combination therapy is safe.|Up to 10 courses|This outcome measure evaluates the first 30 patients to enroll and who receive at least one dose of hu14.18-IL2.||participants|||Number
840260|NCT01334554|Secondary|Endothelial Function|Endothelial function was measured with flow mediated dilation, percent change|Difference between FMD at baseline and 4 weeks|We detected problems with the ultrasound images obtained to measure flow mediated dilation and therefore only data in 14 subjects in the sildenafil group and in 16 subjects in the placebo were analyzed.||percentage of brachial artery diameter|percent change of brachial artery diamet|Standard Deviation|Mean
840261|NCT01334554|Primary|Insulin Sensitivity|insulin sensitivity as measured by frequently sampled intravenous glucose tolerance test|Insulin sensitivity measured at baseline and 4 weeks after the intervention|||min-1/pmol/mlx10-5||Standard Deviation|Median
840262|NCT01334606|Secondary|User Acceptability|"After using each pen needle for three weeks, subjects will be asked to respond Yes or No to the question Were the pen needles used for long acting insulin injections at doses greater than 40 units during this past study period acceptable to you? This outcome measure will be determined for the total subject population as well as for the subset of Lantus users."|End of Period 1 (three weeks) and Period 2 (six weeks)||||||
840263|NCT01334606|Secondary|Relative Injection Pain|"Subjects will complete a 150 mm Visual Analog Scale (VAS). The VAS is a measure of the pain perceived with the needle they are using at that point in the study relative to the needle they used the previous period. The VAS is anchored at the center (0mm) with as painful and at each extreme with much less painful (-75mm) and much more painful (+75mm). The sign of each VAS score will be adjusted for the order of pen needle (PN) use, such that the 8mm short PN is always considered the reference."|End of Period 2 (six weeks)||||||
840264|NCT01334606|Secondary|Percentage of Subjects With at Least One Leakage Event|Leakage will be assessed by the subject after any injections of long-acting insulin of greater than 40 units. Subjects will record in their study diary if they observed insulin leakage from the injection site.|3 weeks per pen needle||||||
840265|NCT01334606|Secondary|Glycemic Control as Measured by Fasting Blood Glucose|The measure of glycemic control will be the percent difference in fasting blood glucose (FBG) assessed at the end of Period 1 and Period 2. The average percent difference in FBG between the Nano and Short pen needles, with the Short as a reference, must be shown to be no more than +/- 20% with 95% confidence. General linear models will be used, adjusted for baseline FBG. This outcome measure will be determined for the total subject population as well as for the subset of Lantus users.|3 weeks per pen needle||||||
840277|NCT01334866|Secondary|Composite Major Adverse Event Rate (Late)|"Characterize the composite major adverse event rate after 30 days post-procedure or hospital discharge, whichever is longer through the 6-Month evaluation. The major adverse events will include:
Major hemorrhage/bleeding requiring surgical intervention
Aortic complications
Graft vessel revision (GVR)
Transient ischemic attacks (TIA)
Cerebrovascular accidents (CVA)/stroke
Myocardial infarction (MI)
Death"|After 30 days post-procedure or hospital discharge, whichever is longer through the 6-Month evaluation|||percentage of subjects|||Number
840266|NCT01334606|Primary|Glycemic Control as Measured by Percent (%) Absolute Change in Fructosamine|The measure of glycemic control will be the percent difference in FRU assessed at the end of Period 1 compared to FRU assessed at the end of Period 2. The average percent difference in FRU between the Nano and Short pen needles, with the Short as a reference, must be shown to be no more than +/- 20% with 95% confidence. General linear models will be used, adjusting for baseline FRU. This outcome measure was to be determined for the total subject population as well as for the subset of Lantus users.|3 weeks per pen needle|No analysis was performed. The study was terminated due to slow enrollment. The same endpoint was studied and reported in a similar subject population, including Lantus users, in study DBC-11-SQUIR05(NCT01231984)which had a similar design.|||||
840267|NCT01334710|Secondary|Toxicity Assessment|Evaluate the proportion of participants treated with OSI-906 and sorafenib who develop serious adverse events.|28 days from study entry||||||
840268|NCT01334710|Primary|Comparison of MRI/CT Scans to Pre-treatment Scan|Efficacy will be measured by evaluating the number of patients who do not have disease progression (measured by CT or MRI scan) 5 months after starting treatment. Assessment of the endpoint of disease progression will be performed every 2 months using either CT or MRI scan. Participants will remain on the study until either evidence of disease progression or unacceptable side effects develop. This period is expected to be on the average 6 months long.|6 months||||||
840269|NCT01334723|Secondary|BPH-Related Costs for Every 30 Days of 5-ARI Therapy|In this analysis, we evaluated mean BPH-related costs for every 30 days of 5-ARI therapy. Mean costs were evaluated by month on therapy for BPH-related medical costs (defined as any claim with a primary ICD-9-CM code of 222.2 or 600.xx).|Up to one year following the first pharmacy claim for 5ARI therapy or medical encounter for AUR or prostate surgery in the 5 and a half year period from January 1, 2000 to June 30, 2006|Enrolled Population||United States dollars per month||Standard Deviation|Mean
840270|NCT01334723|Secondary|Mean BPH-Related Costs for Participants With an MPR >=80% Versus <80%|In this analysis, we evaluated mean BPH-related costs per month for participants with an MPR of >=80% versus <80%. Mean costs were evaluated by month on therapy for BPH-related medical costs (defined as any claim with a primary ICD-9-CM code of 222.2 or 600.xx).|Up to one year following the first pharmacy claim for 5ARI therapy or medical encounter for AUR or prostate surgery in the 5 and a half year period from January 1, 2000 to June 30, 2006|Enrolled Population||United States dollars per month||Standard Deviation|Mean
840271|NCT01334723|Secondary|Mean BPH-Related Costs for Participants With an MPR >=75% Versus <75%|In this analysis, we evaluated mean BPH-related costs per month for participants with an MPR of >=75% versus <75%. Mean costs were evaluated by month on therapy for BPH-related medical costs (defined as any claim with a primary ICD-9-CM code of 222.2 or 600.xx).|Up to one year following the first pharmacy claim for 5ARI therapy or medical encounter for AUR or prostate surgery in the 5 and a half year period from January 1, 2000 to June 30, 2006|Enrolled Population||United States dollars per month||Standard Deviation|Mean
840272|NCT01334723|Secondary|Mean BPH-Related Costs for Participants With an MPR >=70% Versus <70%|In this analysis, we evaluated mean BPH-related costs per month for participants with an MPR of >=70% versus <70%. Mean costs were evaluated by month on therapy for BPH-related medical costs (defined as any claim with a primary ICD-9-CM code of 222.2 or 600.xx).|Up to one year following the first pharmacy claim for 5ARI therapy or medical encounter for AUR or prostate surgery in the 5 and a half year period from January 1, 2000 to June 30, 2006|Enrolled Population||United States dollars per month||Standard Deviation|Mean
840273|NCT01334723|Secondary|Mean Length of 5-ARI Therapy|In this analysis, we evaluated the association between 5-ARI length of therapy and risk of acute urinary retention and prostate surgery.|Up to one year following the first pharmacy claim for 5ARI therapy or medical encounter for AUR or prostate surgery in the 5 and a half year period from January 1, 2000 to June 30, 2006|Enrolled Population||days||Standard Deviation|Mean
840274|NCT01334723|Primary|Number of Participants With Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 80%|Claims-based definition of AUR and surgery based on the presence of an ICD-9-CM code of 599.6x, 788.20, or 788.29 and CPT procedure codes, respectively. For this analysis, we evaluated the association between compliance with 5-ARI therapy (measured by medication possession ratio [MPR]) and risk of AUR and surgery. MPR was calculated as the number of days that 5-ARI therapy was taken divided by the total number of follow-up days. For this analysis, the threshold for compliance was set at MPR = 80%.|Up to one year following the first pharmacy claim for 5ARI therapy or medical encounter for AUR or prostate surgery in the 5 and a half year period from January 1, 2000 to June 30, 2006|Enrolled Population||participants|||Number
840275|NCT01334723|Primary|Number of Participants With Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 75%|Claims-based definition of AUR and surgery based on the presence of an ICD-9-CM code of 599.6x, 788.20, or 788.29 and CPT procedure codes, respectively. For this analysis, we evaluated the association between compliance with 5-ARI therapy (measured by medication possession ratio [MPR]) and risk of AUR and surgery. MPR was calculated as the number of days that 5-ARI therapy was taken divided by the total number of follow-up days. For this analysis, the threshold for compliance was set at MPR = 75%.|Up to one year following the first pharmacy claim for 5ARI therapy or medical encounter for AUR or prostate surgery in the 5 and a half year period from January 1, 2000 to June 30, 2006|Enrolled Population||participants|||Number
840276|NCT01334723|Primary|Number of Participants With Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 70%|Claims-based definition of acute urinary retention (AUR) and surgery based on the presence of an ICD-9-CM code of 599.6x, 788.20, or 788.29 and CPT procedure codes, respectively. For this analysis, we evaluated the association between compliance with 5-ARI therapy (measured by medication possession ratio [MPR]) and risk of AUR or surgery. MPR was calculated as the number of days that 5-ARI therapy was taken divided by the total number of follow-up days. For this analysis, the threshold for compliance was set at MPR = 70%.|The 5 and a half year period from January 1, 2000 to June 30, 2006|Enrolled Population: participants in the IHCIS database with a diagnosis of benign prostate hyperplasia or enlarged prostate as indicated by ICD-9-CM code on claims (222.2x or 600.xx). Participants were included if they had at least 60 days of 5-ARI therapy during the enrollment period, 6 months of continuous enrollment, and no prior surgery.||participants|||Number
840303|NCT01334957|Primary|To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Reduction of Post-operative Pain.|The incidence of treatment-emergent adverse events occurring in the six hours following administration of the first dose of intravenous ibuprofen|6 hours|||Number of Adverse Events|||Number
840278|NCT01334866|Primary|Composite Major Adverse Event Rate (Early)|"During procedure and within 30 days post-procedure or hospital discharge, whichever is longer. The adverse events will include:
Major hemorrhage/bleeding requiring surgical intervention
Aortic complications
Graft vessel revision (GVR)
Transient ischemic attacks (TIA)
Cerebrovascular accidents (CVA)/stroke
Myocardial infarction (MI)
Death"|During procedure (day 1) and within 30 days post-procedure or hospital discharge, whichever is longer (throughout 6 month evaluation)|||percentage of subjects||95% Confidence Interval|Number
840279|NCT01334866|Primary|Patency of the Index Graft at 6 Months|"For each subject, the endpoint is the percent of stenosis collected on the subject's 6 month angiography form. This will be characterized for each graft using the FitzGibbon scoring system based on the 64-Slice CT Angiography results.
The FitzGibbon Scoring system is as follows:
A:Excellent graft with unimpaired runoff (< 50% stenosis) B:Stenosis reducing caliber of proximal or distal anastomoses or trunk to <50% of the grafted coronary artery.
O:Occluded (100% stenosed)"|6 months post-procedure|||percentage of grafts|Participants||Number
840280|NCT01334866|Primary|Procedural Success in a MICS Approach|A successful procedure can be defined as a procedures not requiring conversion (sternotomy). This will be characterized by whether the graft procedure can be completed through the minimally invasive thoracotomy without having to convert to a sternotomy in order to complete the grafting.|At time of procedure (day 1)|||percentage of subjects|||Number
840281|NCT01334866|Primary|Technical Success (Graft Patency) in a MICS Approach|For each subject, the endpoint for technical success (graft patency) in a MICS approach is defined as acceptable flow for graft size for an anastamosis. This will be characterized by the surgeon's assessment/angiography after the graft is complete.|At time of procedure (day 1)|||percentage of grafts|Participants||Number
840282|NCT01334918|Secondary|Percentage of Participants With Two or More Ischemic Segments on SPECT, But Less on CT|Using SPECT as the reference standard, the false negative percentage was calculated as the percentage of participants with two or more ischemic segments on SPECT, but less on CT.|Day 1 and Day 2|Full analysis set participants with two or more reversible defects.||percentage of participants|||Number
840283|NCT01334918|Secondary|Number of Participants With Fixed Defects|"Using the 17-segment scoring system, a segment scored above 1 (i.e., 2 to 4) and equal at rest and stress was counted as having a fixed defect.
At rest and stress, each segment was scored on a 0 to 4 scale according to the amount of contrast or radiotracer the myocardium in the segment absorbed:
0: normal perfusion
1: slightly reduced contrast/radiotracer uptake
2: moderately reduced contrast/radiotracer uptake
3: severely reduced contrast/radiotracer uptake
4: absent contrast/radiotracer uptake."|Day 1 and Day 2|The number of participants analyzed represents the full analysis set.||participants|||Number
840284|NCT01334918|Secondary|Number of Participants With Reversible Defects in the Left Circumflex Coronary Artery (LCX)|"The number of reversible defects in the LCX categorized into absence or presence of ischemia (0-1 versus ≥2), as assessed by the central imaging laboratory for both SPECT and MDCT.
The 17-segment model for standardized myocardial segmentation was used for myocardial perfusion readings for SPECT and MDCT. At rest and stress, each segment was scored on a 0 to 4 scale according to the amount of contrast or radiotracer the myocardium in the segment absorbed:
0: normal perfusion
1: slightly reduced contrast/radiotracer uptake
2: moderately reduced contrast/radiotracer uptake
3: severely reduced contrast/radiotracer uptake
4: absent contrast/radiotracer uptake.
The median score from 3 blinded readers for each segment was used. If the stress score was ≥ 2 and the rest score was less than the stress score, the segment was counted as having a reversible defect. A participant was classified as ischemic in the presence of ≥ 2 segments with reversible defects, excluding segment 17."|Day 1 and Day 2|The number of participants analyzed represents the full analysis set where scans were available.||participants|||Number
840285|NCT01334918|Secondary|Number of Participants With Reversible Defects in the Right Coronary Artery (RCA)|"The number of reversible defects in the RCA categorized into absence or presence of ischemia (0-1 versus ≥2), as assessed by the central imaging laboratory for both SPECT and MDCT.
The 17-segment model for standardized myocardial segmentation was used for myocardial perfusion readings for SPECT and MDCT. At rest and stress, each segment was scored on a 0 to 4 scale according to the amount of contrast or radiotracer the myocardium in the segment absorbed:
0: normal perfusion
1: slightly reduced contrast/radiotracer uptake
2: moderately reduced contrast/radiotracer uptake
3: severely reduced contrast/radiotracer uptake
4: absent contrast/radiotracer uptake.
The median score from 3 blinded readers for each segment was used. If the stress score was ≥ 2 and the rest score was less than the stress score, the segment was counted as having a reversible defect. A participant was classified as ischemic in the presence of ≥ 2 segments with reversible defects, excluding segment 17."|Day 1 and Day 2|The number of participants analyzed represents the full analysis set where scans were available.||participants|||Number
840286|NCT01334918|Secondary|Number of Participants With Reversible Defects in the Left Anterior Descending Coronary Artery (LAD)|"The number of reversible defects in the LAD categorized into absence or presence of ischemia (0–1 versus ≥2), as assessed by the central imaging laboratory for both SPECT and MDCT.
The 17-segment model for standardized myocardial segmentation was used for myocardial perfusion readings for SPECT and MDCT. At rest and stress, each segment was scored on a 0 to 4 scale according to the amount of contrast or radiotracer the myocardium in the segment absorbed:
0: normal perfusion
1: slightly reduced contrast/radiotracer uptake
2: moderately reduced contrast/radiotracer uptake
3: severely reduced contrast/radiotracer uptake
4: absent contrast/radiotracer uptake.
The median score from 3 blinded readers for each segment was used. If the stress score was ≥ 2 and the rest score was less than the stress score, the segment was counted as having a reversible defect. A participant was classified as ischemic in the presence of ≥ 2 segments with reversible defects, excluding segment 17."|Day 1 and Day 2|The number of participants analyzed represents the full analysis set where scans were available.||participants|||Number
840287|NCT01334918|Secondary|Overall Image Quality of Scans by Modality and Reviewer|Overall image quality was assessed by three independent blinded readers for each modality (single photon emission computed tomography (SPECT) and multidetector computed tomography (MDCT)). Image quality was rated on a 4-point scale as either excellent, good, fair or poor at rest using SPECT and MDCT and under stress using regadenoson SPECT and regadenoson stress computed tomography perfusion (CTP).|Day 1 and Day 2|The number of participants analyzed represents the full analysis set.||participants|||Number
840386|NCT01328756|Primary|Change From Baseline in Height at Last On-treatment Assessment (LOTA)||Baseline (Week 0), LOTA (Week 104)|Safety population with participants evaluable for this outcome||centimeter(s)||Standard Deviation|Mean
840288|NCT01334918|Primary|Number of Participants With Reversible Defects|"The number of reversible defects categorized into absence or presence of ischemia (0–1 versus ≥2), as assessed by the central imaging laboratory for both SPECT and MDCT.
The 17-segment model for standardized myocardial segmentation was used for myocardial perfusion readings for SPECT and MDCT. At rest and stress, each segment was scored on a 0 to 4 scale according to the amount of contrast or radiotracer the myocardium in the segment absorbed:
0: normal perfusion
1: slightly reduced contrast/radiotracer uptake
2: moderately reduced contrast/radiotracer uptake
3: severely reduced contrast/radiotracer uptake
4: absent contrast/radiotracer uptake.
The median score from the 3 blinded readers for each segment was used. If the stress score was ≥ 2 and the rest score was less than the stress score, the segment was counted as having a reversible defect. A participant was classified as ischemic in the presence of 2 or more segments with reversible defects, excluding segment 17."|Day 1 and Day 2|The number of participants analyzed represents the full analysis set, defined as all randomized patients with interpretable SPECT and CTP scans as determined by at least two of the three blinded readers.||participants|||Number
840289|NCT01334944|Secondary|To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain|The incidence of treatment-emergent adverse events occurring through extended dosing.|24 hours|||Number of Events|||Number
840290|NCT01334944|Secondary|To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain|The incidence of treatment-emergent serious adverse events occurring through extended dosing.|24 hours|||Number of Serious Adverse Events|||Number
840291|NCT01334944|Secondary|To Determine the Efficacy of a Single Dose of 800 mg Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Pain (Mild to Moderate or Moderate to Severe).|"The change in patient self-assessment of pain utilizing the visual analog scale (VAS) from baseline over the 4 hours following intravenous ibuprofen administration. The VAS is a continuous scale compromised of a horizontal line, one hundred millimeters in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the No Pain anchor and the subject's mark. The score would be between o and 100."|4 hours|||units on a scale||95% Confidence Interval|Mean
840292|NCT01334944|Secondary|To Determine the Efficacy of a Single Dose of 400 mg Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever|The change in temperature from baseline over the 4 hours following intravenous ibuprofen administration|4 hours|||Degree Fahrenheit||95% Confidence Interval|Mean
840293|NCT01334944|Primary|To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting.|The change from baseline to one hour post administration of intravenous ibuprofen in vital sign assessments (Diastolic Blood Pressure).|1 hour|||mm Hg||95% Confidence Interval|Mean
840294|NCT01334944|Primary|To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting.|The change from baseline to one hour post administration of intravenous ibuprofen in vital sign assessments (Systolic Blood Pressure).|1 hour|||mm Hg||95% Confidence Interval|Mean
840295|NCT01334944|Primary|To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting.|The change from baseline to one hour post administration of intravenous ibuprofen in vital sign assessments (Respiratory Rate).|1 hour|||Breaths Per Minute||95% Confidence Interval|Mean
840296|NCT01334944|Primary|To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting.|The change from baseline to one hour post administration of intravenous ibuprofen in vital sign assessments (Heart Rate).|1 hour|||Beats Per Minute||95% Confidence Interval|Mean
840297|NCT01334944|Primary|To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting|The change from baseline to one hour post administration of intravenous ibuprofen in vitals sign assessments (Temperature)|1 hour|||Degree Fahrenheit||95% Confidence Interval|Mean
840298|NCT01334944|Primary|To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting.|The incidence of treatment-emergent adverse events occurring in the six hours following administration of intravenous ibuprofen.|6 hours|This analysis was conducted on participants treated with a fever or pain indication that received only a single dose of intravenous ibuprofen||Number of Events|||Number
840299|NCT01334944|Primary|To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting.|The incidence of treatment-emergent serious adverse events occurring in the six hours following administration of the last dose of intravenous ibuprofen|6 hours|||Number of Serious Adverse Events|||Number
840300|NCT01334957|Secondary|To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Reduction of Post-operative Pain.|"Visual Analog Scale (VAS) assessments following surgery. The VAS is a continuous scale compromised of a horizontal line, one hundred millimeters in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the No Pain anchor and the subject's mark. The score would be between o and 100."|6 hours|||units on a scale||95% Confidence Interval|Mean
840301|NCT01334957|Secondary|To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Reduction of Post-operative Pain.|The incidence of treatment-emergent adverse events occurring in the six hours following administration of the last dose of intravenous ibuprofen|6 hours|||Number of Adverse Events|||Number
840302|NCT01334957|Secondary|To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Over 5-10 Minutes for the Reduction of Pain.|The incidence of treatment-emergent serious adverse events occurring in the six hours following administration of the last dose of intravenous ibuprofen|6 hours|||Number of Serious Adverse Events|||Number
840305|NCT01335061|Secondary|Incidence of Less Than Expected Therapeutic Effect (LETE)|The following criteria are the definitions for LETE in this study: 1. LETE in the On-Demand Setting: LETE occurs in the on-demand setting if 2 successive “No Response” ratings are recorded after 2 successive BeneFIX drug infusions in the absence of confounding factors. 2. LETE in the Prophylaxis Setting: LETE occurs in the prophylaxis setting if there is a spontaneous bleed within 48 hours (≤ 48 hours) after a regularly scheduled prophylactic dose of BeneFIX in the absence of confounding factors. 3. LETE (Low Recovery): LETE can also be lower than expected recovery of FIX in the opinion of the investigator following infusion of BeneFIX in the absence of confounding factors. Each reported occurrence of low recovery LETE was listed.|2 years|The safety analysis set (SAS) was any participant who received at least one dose of BeneFIX, including the dose given during the enrollment visit (Visit 2) for the factor IX (FIX) recovery study.||Percentage of occurence|||Number
840306|NCT01335061|Secondary|Total Factor Consumption.|The total amount (IU) infused for each infusion recorded were summed to calculate the total factor consumption for each participant. For each infusion, IU/kg was calculated, using the most recently recorded weight measurement and the total factor consumption, divided by number of infusions, and was summarized similarly to average infusion dose (IU). Annualized TFC by weight was reported. Annualized TFC by weight = (Total IU/kg / treatment interval duration)*365.25.|2 years|The safety analysis set (SAS) was any participant who received at least one dose of BeneFIX, including the dose given during the enrollment visit (Visit 2) for the factor IX (FIX) recovery study.||IU/Kg||Standard Deviation|Mean
840307|NCT01335061|Secondary|Average Infusion Dose.|The mean dose by per infusion by weight (IU/kg) was reported for both prophylaxis and on demand infusions|2 years|The safety analysis set (SAS) was any participant who received at least one dose of BeneFIX, including the dose given during the enrollment visit (Visit 2) for the factor IX (FIX) recovery study.||IU/Kg||Standard Deviation|Mean
840308|NCT01335061|Secondary|Number of Breakthrough (Spontaneous/Non-Traumatic) Bleeds Within 48 Hours of a Prophylaxis Dose of BeneFIX.|The number of spontaneous, non-traumatic breakthrough bleeds within 48 hours following a prophylaxis dose of BeneFIX were summarized. If there was more than one bleed location (eg, ankle and joint) with identical bleed start date and time, it was treated as one bleed occurrence.|2 years|The safety analysis set (SAS) was any participant who received at least one dose of BeneFIX, including the dose given during the enrollment visit (Visit 2) for the factor IX (FIX) recovery study. Three participants experienced 1 spontaneous bleeding episode each within 48 hours of a previous prophylaxis infusion.||Number of breakthrough bleeds|Participants|Standard Deviation|Mean
840309|NCT01335061|Secondary|Number of Nonacog Alfa, Recombinant Factor IX (BeneFIX) Infusions Used to Treat Each Bleeding Episode.|The number of study drug infusions administered to treat a bleed will be calculated by adding the initial (on-demand) infusion to any subsequent (on-demand) infusions for the same bleed (same bleed start date/time). The number of infusions needed to treat a bleed will be classified into the following categories: 1, 2, 3, 4 and >4 infusions. If there were more than one bleed location (e.g., ankle and joint) with identical bleed start date and time, it was treated as one bleed occurrence.|2 years|The safety analysis set (SAS) was any participant who received at least one dose of BeneFIX, including the dose given during the enrollment visit (Visit 2) for the factor IX (FIX) recovery study.||Number of bleeds requiring infusion|Participants||Number
840310|NCT01335061|Secondary|Response to On-Demand Treatment for All Bleeding Episodes.|Assessment scores on a 4-point Response Scale for an on-demand bleeding episode, as assessed by participant/caregiver or investigator/qualified staff. The 4-point scale assessments are Excellent, Good, Moderate or No response. Responses to number of observations were noted.|2 years|The safety analysis set (SAS) was any participant who received at least one dose of BeneFIX, including the dose given during the enrollment visit (Visit 2) for the factor IX (FIX) recovery study. Follow-up infusion was only required for 18 participants.||Number of observations with response|Participants||Number
840311|NCT01335061|Primary|Annualized Number of Bleeding Episodes.|The annualized bleed rate (ABR) or the annualized number of bleeding episodes per year, will be derived for each participant for each treatment period by using the following formula: ABR = number of bleeds / (Days on treatment period / 365.25) The number of bleeds for the ABR calculation includes all bleeds requiring treatment with factor IX product during the time on treatment.|2 years|The efficacy analysis set (EAS) was used for the primary efficacy analyses with respect to ABR. It includes all participants who participated in at least one day of the routine prophylaxis period (ie, in the study through at least Visit 4).||Number of bleeds per year||Standard Deviation|Mean
840312|NCT01335191|Primary|Anti-Tat Antibody Titer|ELISA based chemiluminescent assay to determine the anti-Tat antibody response|54 weeks|all subjects enrolled||ng/mL||Full Range|Mean
840313|NCT01335230|Primary|Exploring the Role of Gut-associated Th17 in Microbial Translocation in HIV and HCV/HIV Coinfected Patients.|We measure gene transcription of the colon tissues (relative expression fold changes of gene transcription compared to control). No preselected criteria were used to assess the participants. Data were analyzed and compared among each group. Relative expression levels of LEAP-2 (Liver expressed anti-microbial peptide-2) in the four groups were shown in the table below. Detailed of other genes had been published in Shata MT, et al, J. Clin Pathology 2013, Nov 66(11):967-75. PMID 23940131, and Abdel-Hameed et al, J. Acquir Immune Defic Syndr. 2013 Jul 10 PMID: 23846566|One year|All the samples were analyzed for gene array transcriptions and cytokines profiles||relative expression levels||Standard Deviation|Mean
840314|NCT01335308|Secondary|Change in Physical Activity||2 years after enrollment|||Adjusted posttest hours per day||Standard Error|Mean
840315|NCT01335308|Secondary|Sweetened Beverage Consumption||2 years after enrollment|||Adjusted posted test servings per day||Standard Error|Mean
840316|NCT01335308|Secondary|Fruit/Vegetable Consumption||2 years after enrollment|||Post test adjuste, servings per day||Standard Error|Mean
840317|NCT01335308|Primary|Child BMI Percentile||2 years after recruitment|||BMI Percentile||Standard Error|Mean
840318|NCT01335464|Secondary|Change From Baseline in Carbon Monoxide Diffusion Capacity (DLCO) at Rest Over 52 Weeks|Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52).|Baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)||mmol/min/kPa||Standard Error|Mean
840387|NCT01328756|Primary|Change From Baseline in Body Weight at Last On-treatment Assessment (LOTA)||Baseline (Week 0), LOTA (Week 104)|Safety population with participants evaluable for this outcome||kilogram(s)||Standard Deviation|Mean
840319|NCT01335464|Secondary|Change From Baseline in SpO2 (Oxygen Saturation, Expressed in Percent) at Rest up Over 52 Weeks|Means presented are the adjusted means. Adjusted mean is based on all analyzed patients in the model (not only patients with a change from baseline to week 52)|Baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)||percent of oxygen saturation||Standard Error|Mean
840320|NCT01335464|Secondary|Time to Death or Lung Transplant or Qualifying for Lung Transplant Over 52 Weeks.|"Due to rare events, the median of time to event is not calculable, thus the percentages of participants who did or did not experienced death or lung transplant or qualifying for lung transplant over 52 weeks are reported. A patient was considered qualifying for lung transplant by the investigator if he or she fulfilled the following criteria:
FVC <45% predicted or Carbon monoxide diffusion capacity (DL(CO)) <30% pred or Oxygen saturation on pulse oximetry (SpO2) <88% at rest, at sea level (to be adapted for other heights).
These criteria were evaluated by investigators judgement. Failure is the proportion of patients who died or had lung transplant or qualified for lung transplant over 52 weeks (373 days time-period)."|52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)||percentage of participants|||Number
840321|NCT01335464|Secondary|Time to Death or Lung Transplant Over 52 Weeks|"Due to rare events, the median of time to event is not calculable, thus the percentages of participants who did or did not experience event (death or lung transplant) before or at 372 days after randomisation or last contact date (whichever occurs first) are reported.
Failure is the proportion of patients who died or had lung transplant over 52 weeks (373 days time-period)."|52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)||percentage of participants|||Number
840322|NCT01335464|Secondary|Time to On-treatment Death|"Due to rare events, the median of time to event is not calculable, thus the percentages of participants who did or did not die before or at last trial medication intake + 28 days were censored at last trial medication intake + 28 days and reported.
Failure is the the proportion of patients who died on-treatment."|52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)||percentage of participants|||Number
840323|NCT01335464|Secondary|Time to Death Due to Respiratory Cause Over 52 Weeks (Adjudicated)|"Due to rare events, the median of time to event is not calculable, thus the percentages of participants who did or did not experienced death due to respiratory causes before or at 372 days after randomisation or last contact date (whichever occurs first) are reported.
Failure is the the proportion of patients who died due to respiratory causes over 52 weeks (373 days time-period)."|52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)||percentage of participants|||Number
840324|NCT01335464|Secondary|Time to Death Over 52 Weeks|"Due to rare events, the median of time to event is not calculable, thus the percentages of patients who did or did not experienced death before or at 372 days after randomisation or last contact date (whichever occurs first) are reported.
Failure is the proportion of patients who died over 52 weeks (373 days time-period) ."|52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)||percentage of participants|||Number
840325|NCT01335464|Secondary|Risk of an Acute IPF Exacerbation Over 52 Weeks|The incidence rate of exacerbations (calculated as the number of patients with at least 1 acute IPF exacerbation divided by the total number of years at risk in years*100)|52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)||Participants/Year *100|||Number
840326|NCT01335464|Secondary|Change From Baseline in EuroQol 5-Dimensional Quality of Life Questionnaire (EQ-5D) Health State up to 52 Weeks : Patient Reported Outcomes (PROs)|The EuroQol 5-dimensional Health State is based on a visual analog scale (EQ-VAS) representing the general patient’s health state labelled from 100 (best imaginable health state) to 0 (worst imaginable health state). A higher score indicating a better health state. Change from baseline is calculated as the difference between health state at week 12, 24 and 52 respectively and health state at baseline as measured by the scale.|baseline, 12 weeks, 24 weeks and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)||points on a scale||Standard Deviation|Mean
840327|NCT01335464|Secondary|Proportion of Patient’s Global Impression of Change (PGI-C) Responders at 52 Weeks: Patient Reported Outcomes (PROs)|Patient's Global Impression of Change (PGI-C) responders are defined as 'Very much better'/ 'Much better'/ 'A little better'/ 'No change'.|52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)||percentage of participants||95% Confidence Interval|Number
840328|NCT01335464|Secondary|Change From Baseline in Cough Impact Score of the Cough and Sputum Assessment Questionnaire (CASA-Q) Score at 52 Weeks : Patient Reported Outcomes (PROs)|"The cough domains of the Cough and Sputum Assessment Questionnaire (CASA-Q) assess the frequency and severity of cough and sputum and their impact on everyday life. It contains 4 domains cough/sputum symptom and impact with each scale ranging from 0 to 100 with lower scores indicating higher symptoms/impact levels (worst outcome).
Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)."|Baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)||points on a scale||Standard Error|Mean
840329|NCT01335464|Secondary|Change From Baseline in Cough Symptoms Score of the Cough and Sputum Assessment Questionnaire (CASA-Q) Score at 52 Weeks: Patient Reported Outcomes (PROs)|"The cough domains of the Cough and Sputum Assessment Questionnaire (CASAQ(CD)) assess the frequency and severity of cough and sputum and their impact on everyday life. It contains 4 domains cough/sputum symptom and impact with each scale ranging from 0 to 100 with lower scores indicating higher symptoms/impact levels (worst outcome).
Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)."|Baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)||points on a scale||Standard Error|Mean
840330|NCT01335464|Secondary|Change From Baseline in Shortness of Breath Questionnaire (SOBQ) at 52 Weeks: Patient Reported Outcomes (PROs)|"Shortness of Breath Questionnaire measures the shortness of breath. It comprises of 24 items. Each item is scored on a scale between 0-5 where 5 represents maximal breathlessness. The responses to all items are summed up to provide the overall score that can range from 0 (best outcome) to 120 (worst outcome).
Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)."|baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)||points on a scale||Standard Error|Mean
840331|NCT01335464|Secondary|Change From Baseline in Idiopathic Pulmonary Fibrosis (IPF) Specific Version of SGRQ (SGRQ-I) Total Score at 52 Weeks (Points): Patient Reported Outcomes (PROs)|"SGRQ-I is the IPF specific version of SGRQ comprises of selected items from the SGRQ divided into three components, Symptoms, Activity and Impact. Each component is scored separately. The weights for all items with a positive responses are summed and the weights from missed items are deducted from the maximum possible weight for the total score.
The total score is calculated by dividing the summed weights from positive items in the questionnaire by maximum possible weight for all items in the questionnaire. The total score can range from 0 to 100 with a lower score denoting a better health-related quality of life. Change from baseline is calculated as the difference between total score at week 52 and total score at baseline as measured by the scale."|Baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)||points on a scale||Standard Error|Mean
840332|NCT01335464|Secondary|Change From Baseline in SGRQ Activity Score at 52 Weeks (Points): Patient Reported Outcomes (PROs)|"SGRQ Activity score is a sub-component of SGRQ total score and concerned with activities that cause or are limited by breathlessness. This score calculated as summed weights ranges from 0 to 100 with lower score denoting a better activity-related quality of life.
Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)."|baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)||points on scale||Standard Error|Mean
840333|NCT01335464|Secondary|Change From Baseline in SGRQ Impact Score at 52 Weeks (Points): Patient Reported Outcomes (PROs)|"SGRQ Impact score is a sub-component of SGRQ total score and covers a range of aspects concerned with social functioning and psychological disturbances resulting from airway disease. This score calculated as summed weights ranges from 0 to 100 with lower score denoting a better impact-related quality of life.
Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)."|Baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)||points on a scale||Standard Error|Mean
840334|NCT01335464|Secondary|Change From Baseline in SGRQ Symptom Score at 52 Weeks: Patient Reported Outcomes (PROs)|"SGRQ Symptom score is a sub-component of SGRQ total score and is concerned with the effect of respiratory symptoms, their frequency and severity. This score calculated as summed weights ranges from 0 to 100 with lower score denoting a better symptom-related quality of life.
Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)."|Baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)||points on a scale||Standard Error|Mean
840335|NCT01335464|Secondary|Proportion of SGRQ Responders at 52 Weeks: Patient Reported Outcomes (PROs)|"Proportion of SGRQ responders at 52 weeks
Responders defined as <= -4 points change in change from baseline in SGRQ total score at 52 weeks."|Baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)||percentage of participants||95% Confidence Interval|Number
840336|NCT01335464|Secondary|Proportion of FVC Responders Using 5% Threshold at 52 Weeks|Proportion of FVC responders using 5% threshold at 52 weeks, defined as patients with absolute decline in FVC% predicted no greater than 5% and with an FVC evaluation at 52 weeks.|52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)||percentage of participants||95% Confidence Interval|Number
840337|NCT01335464|Secondary|FVC Responders Using 10% Threshold at 52 Weeks|FVC responders using 10% threshold at 52 weeks, defined as patients with absolute decline in FVC% predicted no greater than 10% and with an FVC evaluation at 52 weeks.|52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)||percentage of participants||95% Confidence Interval|Number
840338|NCT01335464|Secondary|Absolute Categorical Change of FVC (% Predicted) by Categories Over 52 Weeks - 10% Threshold|Absolute categorical change of FVC (% predicted) by categories over 52 weeks - 10% threshold (decrease by 10%, increase by >10%, and change within ≤10%)|Baseline and 52 weeks|TS (for patients with change from baseline in FVC (%predicted) at Week 52)||percentage of participants|||Number
840339|NCT01335464|Secondary|Absolute Categorical Change of FVC (% Predicted) by Categories Over 52 Weeks - 5% Threshold|Absolute categorical change of FVC (% predicted) by categories over 52 weeks - 5% threshold (decrease by >5%, increase by >5%, and change within ≤5%).|Baseline and 52 weeks|TS (for patients with change from baseline in FVC (%predicted) at Week 52)||percentage of participants|||Number
840340|NCT01335464|Secondary|Relative Change From Baseline in Forced Vital Capacity (FVC) (% Predicted) Over 52 Weeks|Percentage change from baseline in FVC (% predicted) at 52 weeks. Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52).|Baseline and 52 weeks|TS (Only patients with observed cases (OC) values were analysed)||percent change||Standard Error|Mean
840341|NCT01335464|Secondary|Absolute Change From Baseline in Forced Vital Capacity (FVC) (% Predicted) Over 52 Weeks|Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52).|Baseline and 52 weeks|TS (Only patients with observed cases (OC) values were analysed)||% predicted||Standard Error|Mean
840342|NCT01335464|Secondary|Relative Change From Baseline in Forced Vital Capacity (FVC) Over 52 Weeks|Percentage change from baseline in FVC over 52 weeks. Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52).|Baseline and 52 weeks|TS (Only patients with observed cases (OC) values were analysed)||percent change||Standard Error|Mean
840343|NCT01335464|Secondary|Absolute Change From Baseline in Forced Vital Capacity (FVC) Over 52 Weeks|Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52).|Baseline and 52 weeks|TS (Only patients with observed cases (OC) values were analysed)||mL||Standard Error|Mean
840357|NCT01335477|Secondary|Change From Baseline in Cough Impact Score of the Cough and Sputum Assessment Questionnaire (CASA-Q) Score at 52 Weeks: Patient Reported Outcomes (PROs)|"The cough domains of the Cough and Sputum Assessment Questionnaire (CASA- Q) assess the frequency and severity of cough and sputum and their impact on everyday life. It contains 4 domains cough/sputum symptom and impact with each scale ranging from 0 to 100 with lower scores indicating higher symptoms/impact levels (worst outcome).
Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)."|baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)||points on a scale||Standard Error|Mean
840344|NCT01335464|Secondary|Time to First Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation|"Due to rare events, the median of time to event is not calculable, thus the percentages of patients with (IPF) exacerbation are reported and represented as a key secondary endpoint. An acute exacerbation (reported as an AE by the investigator) was defined as follows:
Otherwise unexplained clinical features including all of the following:
Unexplained worsening or development of dyspnoea within 30 days
New diffuse pulmonary infiltrates on chest X-ray, and/or new HRCT parenchymal abnormalities with no pneumothorax or pleural effusion (new ground-glass opacities) since the last visit
Exclusion of infection as per routine clinical practice and microbiological studies
Exclusion of alternative causes as per routine clinical practice including left heart failure, pulmonary embolism and identifiable cause of acute lung injury.
Failure is the proportion of patients with at least one acute IPF exacerbation over 52 weeks, based on all investigator-reported AEs ."|52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)||percentage of participants|||Number
840345|NCT01335464|Secondary|Change From Baseline in Saint-George's Respiratory Questionnaire (SGRQ) Total Score at 52 Weeks|"This is a key secondary endpoint.
SGRQ is a health-related quality of life questionnaire divided into 3 components : symptoms, activity and impact.
The total score (summed weights) can range from 0 to 100 with a lower score denoting a better health status.
Means provided are the adjusted means based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)."|baseline and 52 weeks|TS (Only patients with observed cases (OC) values were analysed)||points on a scale||Standard Error|Mean
840346|NCT01335464|Primary|Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks|"Forced vital capacity (FVC) is the total amount of air exhaled during the lung function test.
For this endpoint reported means represent the adjusted rate"|52 weeks|TS (Only patients with observed cases (OC) values were analysed)||mL/year||Standard Error|Mean
840347|NCT01335477|Secondary|Change From Baseline in Carbon Monoxide Diffusion Capacity (DLCO) at Rest Over 52 Weeks|Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52).|baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)||mmol/min/kPa||Standard Error|Mean
840348|NCT01335477|Secondary|Change From Baseline in SpO2 (Oxygen Saturation, Expressed in Percent) at Rest up Over 52 Weeks|Means presented are the adjusted means. Adjusted mean is based on all analyzed patients in the model (not only patients with a change from baseline to week 52)|baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)||percent of oxygen saturation||Standard Error|Mean
840349|NCT01335477|Secondary|Time to Death or Lung Transplant or Qualifying for Lung Transplant Over 52 Weeks.|"Due to rare events, the median of time to event is not calculable, thus the percentages of participants who did or did not experienced death or lung transplant or qualifying for lung transplant over 52 weeks are reported. A patient was considered qualifying for lung transplant by the investigator if he or she fulfilled the following criteria:
FVC <45% predicted or Carbon monoxide diffusion capacity (DL(CO)) <30% pred or Oxygen saturation on pulse oximetry (SpO2) <88% at rest, at sea level (to be adapted for other heights).
These criteria were evaluated by investigators judgement. Failure is the proportion of patients who died or had lung transplant or qualified for lung transplant over 52 weeks (373 days time-period)."|52 weeks|Treated Set||percentage of participants|||Number
840350|NCT01335477|Secondary|Time to Death or Lung Transplant Over 52 Weeks|Due to rare events, the median of time to event is not calculable, thus the percentages of participants who did or did not experience event (death or lung transplant) before or at 372 days after randomisation or last contact date (whichever occurs first) are reported. Failure is the proportion of patients who died or had lung transplant over 52 weeks (373 days time-period).|52 weeks|Treated Set||percentage of participants|||Number
840351|NCT01335477|Secondary|Time to On-treatment Death|"Due to rare events, the median of time to event is not calculable, thus the percentages of participants who did or did not die before or at last trial medication intake + 28 days were censored at last trial medication intake + 28 days and reported.
Failure is the the proportion of patients who died on-treatment."|52 weeks|Treated Set||percentage of participants|||Number
840352|NCT01335477|Secondary|Time to Death Due to Respiratory Cause Over 52 Weeks (Adjudicated)|"Due to rare events, the median of time to event is not calculable, thus the percentages of participants who did or did not experienced death due to respiratory causes before or at 372 days after randomisation or last contact date (whichever occurs first) are reported.
Failure is the the proportion of patients who died due to respiratory causes over 52 weeks (373 days time-period)."|52 weeks|Treated Set||percentage of participants|||Number
840353|NCT01335477|Secondary|Time to Death Over 52 Weeks|"Due to rare events, the median of time to event is not calculable, thus the percentages of patients who did or did not experienced death before or at 372 days after randomisation or last contact date (whichever occurs first) are reported.
Failure is the proportion of patients who died over 52 weeks (373 days time-period)."|52 weeks|Treated Set||percentage of participants|||Number
840354|NCT01335477|Secondary|Risk of an Acute IPF Exacerbation Over 52 Weeks|The incidence rate of exacerbations (calculated as the number of patients with at least 1 acute IPF exacerbation divided by the total number of years at risk in years*100)|52 weeks|Treated Set||Participants/Year *100|||Number
840355|NCT01335477|Secondary|Change From Baseline in EuroQol 5-Dimensional Quality of Life Questionnaire (EQ-5D) Health State up to 52 Weeks : Patient Reported Outcomes (PROs)|The EuroQol 5-dimensional Health State is based on a visual analog scale (EQ-VAS) representing the general patient's health state labelled from 100 (best imaginable health state) to 0 (worst imaginable health state). A higher score indicating a better health state. Change from baseline is calculated as the difference between health state at week 12, 24 and 52 respectively and health state at baseline as measured by the scale.|baseline, 12 weeks, 24 weeks and 52 weeks|Treated Set||points on a scale||Standard Deviation|Mean
840356|NCT01335477|Secondary|Proportion of Patient’s Global Impression of Change (PGI-C) Responders at 52 Weeks: Patient Reported Outcomes (PROs)|Patient's Global Impression of Change (PGI-C) responders are defined as 'Very much better'/ 'Much better'/ 'A little better'/ 'No change'.|52 weeks|Treated Set||percentage of participants||95% Confidence Interval|Number
840371|NCT01335477|Secondary|Relative Change From Baseline in Forced Vital Capacity (FVC) Over 52 Weeks|Percentage change from baseline in FVC over 52 weeks. Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52).|Baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)||percent change||Standard Error|Mean
840358|NCT01335477|Secondary|Change From Baseline in Cough Symptom Score of the Cough and Sputum Assessment Questionnaire (CASA-Q) Score at 52 Weeks: Patient Reported Outcomes (PROs)|"The cough domains of the Cough and Sputum Assessment Questionnaire (CASAQ(CD)) assess the frequency and severity of cough and sputum and their impact on everyday life. It contains 4 domains cough/sputum symptom and impact with each scale ranging from 0 to 100 with lower scores indicating higher symptoms/impact levels (worst outcome).
Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)."|baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)||points on a scale||Standard Error|Mean
840359|NCT01335477|Secondary|Change From Baseline in Shortness of Breath Questionnaire (SOBQ) at 52 Weeks: Patient Reported Outcomes (PROs)|"Shortness of Breath Questionnaire measures the shortness of breath. It comprises of 24 items. Each item is scored on a scale between 0-5 where 5 represents maximal breathlessness. The responses to all items are summed up to provide the overall score that can range from 0 (best outcome) to 120 (worst outcome).
Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)."|baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)||points on a scale||Standard Error|Mean
840360|NCT01335477|Secondary|Change From Baseline in Idiopathic Pulmonary Fibrosis (IPF) Specific Version of SGRQ (SGRQ-I) Total Score at 52 Weeks (Points): Patient Reported Outcomes (PROs)|"SGRQ-I is the IPF specific version of SGRQ comprises of selected items from the SGRQ divided into three components, Symptoms, Activity and Impact. Each component is scored separately. The weights for all items with a positive responses are summed and the weights from missed items are deducted from the maximum possible weight for the total score.
The total score is calculated by dividing the summed weights from positive items in the questionnaire by maximum possible weight for all items in the questionnaire. The total score can range from 0 to 100 with a lower score denoting a better health-related quality of life. Change from baseline is calculated as the difference between total score at week 52 and total score at baseline as measured by the scale."|baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)||points on a scale||Standard Error|Mean
840361|NCT01335477|Secondary|Change From Baseline in SGRQ Activity Score at 52 Weeks (Points): Patient Reported Outcomes (PROs)|"SGRQ Activity score is a sub-component of SGRQ total score and concerned with activities that cause or are limited by breathlessness. This score calculated as summed weights ranges from 0 to 100 with lower score denoting a better activity-related quality of life.
Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)."|baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)||points on a scale||Standard Error|Mean
840362|NCT01335477|Secondary|Change From Baseline in SGRQ Impact Score at 52 Weeks (Points): Patient Reported Outcomes (PROs)|"SGRQ Impact score is a sub-component of SGRQ total score and covers a range of aspects concerned with social functioning and psychological disturbances resulting from airway disease. This score calculated as summed weights ranges from 0 to 100 with lower score denoting a better impact-related quality of life.
Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)."|baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)||points on a scale||Standard Error|Mean
840363|NCT01335477|Secondary|Change From Baseline in SGRQ Symptom Score at 52 Weeks (Points): Patient Reported Outcomes (PROs)|"SGRQ Symptom score is a sub-component of SGRQ total score and is concerned with the effect of respiratory symptoms, their frequency and severity. This score calculated as summed weights ranges from 0 to 100 with lower score denoting a better symptom-related quality of life.
Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)."|baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)||points on a scale||Standard Error|Mean
840364|NCT01335477|Secondary|Proportion of SGRQ Responders at 52 Weeks: Patient Reported Outcomes (PROs)|"Proportion of SGRQ responders at 52 weeks.
Responders defined as <= -4 points change in change from baseline in SGRQ total score at 52 weeks."|baseline and 52 weeks|Treated Set||percentage of participants||95% Confidence Interval|Number
840365|NCT01335477|Secondary|Proportion of FVC Responders Using 5% Threshold at 52 Weeks|Proportion of FVC responders using 5% threshold at 52 weeks, defined as patients with absolute decline in FVC% predicted no greater than 5% and with an FVC evaluation at 52 weeks.|52 weeks|Treated Set||percentage of participants||95% Confidence Interval|Number
840366|NCT01335477|Secondary|FVC Responders Using 10% Threshold at 52 Weeks|FVC responders using 10% threshold at 52 weeks, defined as patients with absolute decline in FVC% predicted no greater than 10% and with an FVC evaluation at 52 weeks.|52 weeks|Treated Set||percentage of participants||95% Confidence Interval|Number
840367|NCT01335477|Secondary|Absolute Categorical Change From Baseline of FVC (% Predicted) by Categories Over 52 Weeks - 10% Threshold|Absolute categorical change of FVC (% predicted) by categories over 52 weeks - 10% threshold (decrease by 10%, increase by >10%, and change within ≤10%)|Baseline and 52 weeks|Treated Set (for patients with change from baseline in FVC (% predicted) at Week 52)||percentage of participants|||Number
840368|NCT01335477|Secondary|Absolute Categorical Change From Baseline of FVC (% Predicted) by Categories Over 52 Weeks - 5% Threshold|Absolute categorical change of FVC (% predicted) by categories over 52 weeks - 5% threshold (decrease by >5%, increase by >5%, and change within ≤5%).|Baseline and 52 weeks|Treated Set (for patients with change from baseline in FVC (% predicted) at Week 52)||percentage of participants|||Number
840369|NCT01335477|Secondary|Relative Change From Baseline in Forced Vital Capacity (FVC) (% Predicted) Over 52 Weeks|Percentage change from baseline in FVC (% predicted) at 52 weeks. Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52).|Baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)||percent change||Standard Error|Mean
840370|NCT01335477|Secondary|Absolute Change From Baseline in Forced Vital Capacity (FVC) (% Predicted) Over 52 Weeks|Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52).|Baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)||%predicted||Standard Error|Mean
840373|NCT01335477|Secondary|Time to First Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation|"Due to rare events, the median of time to event is not calculable, thus the percentages of patients with (IPF) exacerbation are reported and represented as a key secondary endpoint. An acute exacerbation (reported as an AE by the investigator) was defined as follows:
Otherwise unexplained clinical features including all of the following:
Unexplained worsening or development of dyspnoea within 30 days New diffuse pulmonary infiltrates on chest X-ray, and/or new HRCT parenchymal abnormalities with no pneumothorax or pleural effusion (new ground-glass opacities) since the last visit Exclusion of infection as per routine clinical practice and microbiological studies Exclusion of alternative causes as per routine clinical practice including left heart failure, pulmonary embolism and identifiable cause of acute lung injury.
Failure is the proportion of patients with at least one acute IPF exacerbation over 52 weeks, based on all investigator-reported AEs ."|52 weeks|Treated Set||percentage of participants|||Number
840374|NCT01335477|Secondary|Change From Baseline in Saint George’s Respiratory Questionnaire (SGRQ) Total Score at 52 Weeks|"This is a key secondary endpoint. SGRQ is a health-related quality of life questionnaire divided into 3 components : symptoms, activity and impact.
The total score (summed weights) can range from 0 to 100 with a lower score denoting a better health status.
Means provided are the adjusted means based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)."|Baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)||points on a scale||Standard Error|Mean
840375|NCT01335477|Primary|Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks.|"Forced vital capacity (FVC) is the total amount of air exhaled during the lung function test.
For this endpoint reported means represent the adjusted rate."|52 weeks|Treated Set||mL/year||Standard Error|Mean
840376|NCT01328717|Secondary|Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Evaluation)|Subjects read User Guide(UG)to learn to use the system and performed meter tasks. Study staff observed, then rated subjects' success (1 to 4) at performing tasks. Scale: 1.Performed tasks correctly without assistance. 2.Performed tasks correctly, but was directed to a specific part of the UG by the study staff as in a Customer Service call. 3.Performed tasks correctly, but required additional review/assistance similar to review of a specific function during a Customer Service call. 4.Subject incorrectly performed part of the testing regimen and was unaware of the error.|1 hour|Per protocol||Number of Participants|||Number
840377|NCT01328717|Primary|Percent of Fingerstick Blood Glucose (BG) Results Within +/-20%(>=75 mg/dL) and Within +/- 15mg/dL (<75 mg/dL) of Laboratory Glucose Method|Subjects with diabetes and study staff tested subject fingerstick blood using an investigational blood glucose meter (BGM). BGM results were compared to a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were used to calculate the number of BG results within +/- 20% (for reference BG results >=75mg/dL) and within +/- 15mg/dL(for reference BG results <75mg/dL) of the reference method results.|1 hour|As a result of one subject's low blood sugar (and thus rapidly changing glucose values) during the study, one subject did not complete the study. The remaining 77 subjects tested 2 test strip lots on the system. 2x77(154) test results were available.||Percentage of BG test results|Participants||Number
840378|NCT01328756|Secondary|Number of Participants With Clinical Global Impression-Severity of Illness (CGI-S) at Last On-treatment Assessment (LOTA)|The Clinical Global Impressions (CGI) Scale permits a global evaluation of the participants' severity and improvement over time. This assessment will help guide the clinician on dosing adjustments. The CGI has been used extensively in clinical studies of ADHD. CGI-S was a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants), evaluated by the Investigator.|LOTA (Week 104)|FAS population||participants|||Number
840379|NCT01328756|Secondary|Number of Participants With Clinical Global Impression-Global Improvement (CGI-I) at Last On-treatment Assessment (LOTA)|The Clinical Global Impressions (CGI) Scale permits a global evaluation of the participants' severity and improvement over time. This assessment will help guide the clinician on dosing adjustments. The CGI has been used extensively in clinical studies of ADHD. CGI-I was a 7-point scale ranging from 1 (very much improved) to 7 (very much worse), evaluated by the Investigator.|LOTA (Week 104)|FAS population||participants|||Number
840380|NCT01328756|Secondary|Change From Baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) Total Score at Last On-treatment Assessment (LOTA)|ADHD-RS-IV consisted of 18 items designed to reflect current symptomatology of ADHD based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition - Text Revision (DSM-IV-TR) criteria, completed by the Investigator. Each item was scored from a range of 0 (reflecting no symptoms) to 3 (reflecting severe symptoms) with total scores ranging from 0-54. The 18 items were grouped into 2 sub-scales: hyperactivity/impulsivity (even number items 2-18 with score range of 0 to 27) and inattention (odd number items 1-17 with score range of 0 to 27). Higher scores depicted worse symptoms.|Baseline (Week 0), LOTA (Week 104)|Full Analysis Set (FAS) population included all participants who took at least 1 dose of SPD489 and had at least 1 on-treatment post baseline efficacy assessment.||Scores on a scale||Standard Deviation|Mean
840381|NCT01328756|Primary|Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRSC) Total Scores at Last On-treatment Assessment (LOTA)|The BPRS-C that was designed to provide a characterization of the child and adolescent psychopathology, was used to monitor participant's safety. The BPRS-C assessed 7 independent factors (3 items each), for a total of 21 items that represented behavioural disorders, depression, thinking disturbance, psychomotor excitation, withdrawal retardation, anxiety, and organicity. Each item was rated using a 7-point scale including 0 (not present), 1 (very mild), 2 (mild), 3 (moderate), 4 (moderately severe), 5 (severe), and 6 (extremely severe). Total score is the sum of each item score; range from 0 to 126. Higher score indicated worse psychology.|Baseline (Week 0), LOTA (Week 104)|Safety population with participants evaluable for this outcome||scores on a scale||Standard Deviation|Mean
840382|NCT01328756|Primary|Change From Baseline in QT Interval Corrected Using Fridericia's Formula (QTcF) at Last On-treatment Assessment (LOTA)||Baseline (Week 0), LOTA (Week 104)|Safety population with participants evaluable for this outcome||milliseconds||Standard Deviation|Mean
840383|NCT01328756|Primary|Change From Baseline in QT Interval at Last On-treatment Assessment (LOTA)||Baseline (Week 0), LOTA (Week 104)|Safety population with participants evaluable for this outcome||milliseconds||Standard Deviation|Mean
840384|NCT01328756|Primary|Change From Baseline in Heart Rate at Last On-treatment Assessment (LOTA)||Baseline (Week 0), LOTA (Week 104)|Safety population with participants evaluable for this outcome||beats per minute||Standard Deviation|Mean
840391|NCT01328756|Primary|Number of Participants With All Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. It included both serious and non-serious adverse event. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs were defined as treatment-emergent if they started or worsened during the period between the day of a participant’s first dose of investigational product in this study and the 3 days following cessation of treatment.|Baseline up to 3 days after the last dose of study treatment (up to 2 years)|Safety population included all participants who took at least 1 dose of Lisdexamfetamine dimesylate during this study.||participants|||Number
840392|NCT01328769|Secondary|Change in Endothelial Function|Endothelial function was calculated by software from the manufacturer VENDYS. The measurement was taken by using the index of area under the curve of the finger temperature recovery curve just after releasing a blood pressure cuff. The blood pressure cuff occluded blood flow for 5 minutes as compared to the temperature curve in the non-occluded arm.|Baseline to 6 weeks|||ratio of finger temperature||Standard Deviation|Mean
840393|NCT01328769|Primary|Change in Renal Plasma Flow in Response to Infused Angiotensin II||Baseline to 6 weeks|||ml/minute||Standard Error|Mean
840394|NCT01328782|Secondary|Need for IV Morphine of Fentanyl|Indicates that number of subjects that were in severe pain and thus required IV morphine and/or fentanyl.|First 120 minutes after the end of surgery (surgery close time)|All subjects were included in the analysis.||participants|||Number
840395|NCT01328782|Secondary|Total Dosage in Morphine Equivalents (mg/kg) of All Analgesics Received in Prior to Discharge||Analgesic data collected during first four hours following the end of surgery (surgery close)|All subjects were included in the analysis.||Morphine (po) equivalents [mg*kg-1]||Standard Deviation|Mean
840396|NCT01328782|Secondary|Time (in Minutes) to First Narcotic Administration||first 72 hours after surgery close time|All subjects were included in the analysis.||Minutes||Inter-Quartile Range|Median
840397|NCT01328782|Secondary|Total Quality Pain Management Survey (TQPM) Scores for Questions # 16: Child’s Current Level of Pain, Question # 17: Child’s Worst Level of Pain When Moving Around After Surgery and Question # 18: Child’s Worst Level of Pain While Resting|Total quality pain management survey is validated survey used to assess parents’ perceptions of their child’s pain. Pain is assessed on a dimensionless 10 pt likert scale from 0 (no pain) to 10 (severe pain). Greater pain scores are indicative or more severe pain.|Will be obtained from parent(s) 120 minutes after arrival to the recovery room|Based on number of participants and their parents/legal guardians that completed the survey.||Scores on a scale||Standard Deviation|Mean
840398|NCT01328782|Primary|The Faces Pain Scale-Revised (FSP-R) Scores (Scored 0-10).|The Faces Pain Scale Revised is a dimensionless 10 point likert scale used to assess self-reported pain intensity on a scale from 0 (no pain) to 10 (most pain you can imagine). Greater pain scores are indicative of more severe pain.|Will be obtained 30 - 60 minutes after arrival to the recovery room|Based on the number of participants that self-reported their pain score.||Scores on a scale||Standard Deviation|Mean
840399|NCT01328873|Secondary|Number of Participants With Positive Myocbacteria Results by Culture|To describe the microbiological findings in HSCT and leukemia patients with fever, respiratory symptoms, and pulmonary infiltrates|24-48 hours|||participants|||Number
840400|NCT01328873|Secondary|Number of Participants With Positive Viral Results by PCR|To describe the microbiological findings in HSCT and leukemia patients with fever, respiratory symptoms, and pulmonary infiltrates|24-48 hours|||participants|||Number
840401|NCT01328873|Secondary|Number of Patients With Positive Fungal Results by PCR|To describe the microbiological findings in HSCT and leukemia patients with fever, respiratory symptoms, and pulmonary infiltrates|24-48 hours|||participants|||Number
840402|NCT01328873|Secondary|Number of Participants With Positive Bacterial Results by PCR|To describe the microbiological findings in HSCT and leukemia patients with fever, respiratory symptoms, and pulmonary infiltrates|24-48 hours|||participants|||Number
840403|NCT01328873|Secondary|Number of Patients With Positive CT Result|"To correlate specific types of pulmonary infiltrates (focal, multifocal, or diffuse interstitial or alveolar infiltrates) with microbiological findings. Patients were evaluated by changes on the CT and categorized as follows:
Air space
ground glass/reticular nodular
nodular/cavitary
single patchy infiltrate"|30 days|||participants|||Number
840404|NCT01328873|Primary|Number of Patients With Positive Culture or Molecular Results After Brochoscopy|To determine the diagnostic yield related to fiberoptic bronchoscopy (FOB) with bronchoalveolar lavage (BAL) in hematopoietic stem cell transplant (HSCT) and leukemia patients with acute respiratory symptoms and pulmonary infiltrates utilizing both current standard of care microbiology testing and emerging molecular genetic laboratory assessments.|30 days|||participants|||Number
840405|NCT01328951|Secondary|Percentage of Participants With CR, PR, or SD According to RECIST During Blinded Treatment|Tumor response was evaluated using RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as a ≥30% decrease in the sum of target lesion diameters in reference to the Baseline sum. SD was defined as neither sufficient shrinkage in target lesions to qualify for PR nor sufficient growth to qualify for disease progression. The percentage of participants with a best overall response of CR, PR, or SD (i.e., the disease control rate [DCR]) during the BP was calculated, and corresponding 95% CI was constructed using the Pearson-Clopper method.|Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP)|ITT Population.||percentage of participants||95% Confidence Interval|Number
840428|NCT01329029|Secondary|Time to Mortality Due to COPD Exacerbation During the Treatment Period|Time to event will be calculated as date of onset of event — date of first intake of double-blind study drug + 1 day.|52 Weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized.||days||Full Range|Median
840504|NCT01336296|Secondary|Difference in Renal Function|"Difference in renal function between groups at listed time points assessed by mean serum creatinine. Increased serum creatinine could indicate worsening renal function. A normal serum creatinine range for the transplant population varies by patient, but a typical range for Scr would be 1-2 mg/dL."|Difference at 1 month, 3 months, 6 months, 1 year|||mg/L||Standard Deviation|Mean
840406|NCT01328951|Secondary|Percentage of Participants by Best Overall Response According to RECIST During Blinded Treatment|Tumor response was evaluated using RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as a ≥30% decrease in the sum of target lesion diameters in reference to the Baseline sum. Stable disease (SD) was defined as neither sufficient shrinkage in target lesions to qualify for PR nor sufficient growth to qualify for disease progression. Disease progression (progressive disease/PD) was defined as a ≥20% and ≥5-mm increase in the sum of target lesion diameters in reference to the smallest sum on study and/or substantial worsening in non-target disease. The percentage of participants with each level of best tumor response during the BP was calculated, and corresponding 95% CI was constructed using the Pearson-Clopper method.|Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP)|ITT Population.||percentage of participants||95% Confidence Interval|Number
840407|NCT01328951|Secondary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) According to RECIST During Blinded Treatment|Tumor response was evaluated using RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions and short-axis reduction to less than (<) 10 mm of any pathological lymph nodes. PR was defined as a ≥30% decrease in the sum of target lesion diameters in reference to the Baseline sum. The percentage of participants with a best overall response of either CR or PR (i.e., the objective response rate [ORR]) during the BP was calculated, and corresponding 95% CI was constructed using the Pearson-Clopper method.|Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP)|ITT Population.||percentage of participants||95% Confidence Interval|Number
840408|NCT01328951|Secondary|Percentage of Participants Event-Free (Alive and No Disease Progression) at 6 Months During Blinded Treatment|Tumor response was evaluated using RECIST version 1.1. Disease progression was defined as a ≥20% and ≥5-mm increase in the sum of target lesion diameters in reference to the smallest sum on study and/or substantial worsening in non-target disease. The percentage of participants event-free (i.e., still alive and without disease progression) at 6 months during the BP was calculated.|At 6 months|ITT Population.||percentage of participants||95% Confidence Interval|Number
840409|NCT01328951|Secondary|Progression-Free Survival (PFS) as Median Time to Event During Blinded Treatment|Tumor response was evaluated using RECIST version 1.1. Disease progression was defined as a ≥20% and ≥5-mm increase in the sum of target lesion diameters in reference to the smallest sum on study and/or substantial worsening in non-target disease. PFS was defined as the interval between date of randomization and date of first documented death or disease progression. Median time to event during the BP was estimated using the Kaplan-Meier method and expressed in weeks.|Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP)|ITT Population.||weeks||95% Confidence Interval|Median
840410|NCT01328951|Secondary|Percentage of Participants Who Died or Experienced Disease Progression During Blinded Treatment|Tumor response was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Disease progression was defined as a greater than or equal to (≥) 20 percent (%) and ≥5-millimeter (mm) increase in the sum of target lesion diameters in reference to the smallest sum on study and/or substantial worsening in non-target disease. The percentage of participants who died or experienced disease progression during the BP was calculated.|Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP)|ITT Population.||percentage of participants|||Number
840411|NCT01328951|Primary|Percentage of Participants Event-Free (Alive) at 1 Year During the Overall Study|Participants were followed for survival until death or premature withdrawal. The percentage of participants event-free (i.e., still alive) at 1 year during the Overall Study was calculated.|At 1 year|ITT Population.||percentage of participants||95% Confidence Interval|Number
840412|NCT01328951|Primary|Overall Survival (OS) as Median Time to Event During the Overall Study|Participants were followed for survival until death or premature withdrawal. OS was defined as the interval between date of randomization and date of death from any cause. Median time to event during the Overall Study (BP, OLP, or SFU) was estimated using the Kaplan-Meier method and expressed in months.|Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP; per local standards during OLP; then every 12 weeks during SFU until death)|ITT Population.||months||95% Confidence Interval|Median
840413|NCT01328951|Primary|Percentage of Participants Who Died During the Overall Study|Participants were followed for survival until death or premature withdrawal. The percentage of participants who died during the Overall Study (BP, OLP, or SFU) was calculated.|Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP; per local standards during OLP; then every 12 weeks during SFU until death)|ITT Population.||percentage of participants|||Number
840414|NCT01328964|Secondary|Mean Monthly Asthma-related Costs (Pharmacy and Medical) During the Post-index Period|The mean total asthma costs are a sum of pharmacy and medical costs. Costs were determined monthly from the pharmacy and medical encounters recorded in the managed care insurance database. All costs were summed for each participant over the 3-12 month follow-up period (post-index period), and a mean monthly cost was calculated by dividing by the follow-up for each participant.|12 months prior to January 1, 2000 to June 30, 2008|Members of the IMS Life Link Health Plans Claims Database (containing data from >=90 managed healthcare plans, encompassing >=60 million lives) who had >=1 pharmacy claim during the study period. FSC participants were matched 1:2 to budesonide and montelukast separately, leading to different numbers analyzed for FSC dependent on cohort of interest.||United States dollars||Standard Deviation|Mean
840415|NCT01328964|Secondary|Number of Asthma-related Hospitalizations, Asthma-related Emergency Department (ED) Visits, and Combined Hospitalizations/ED Visits Represented Per 100 Person Years|The number of participants with an asthma-related event was computed during the follow-up period and was standardized by dividing by the total days of follow-up in each cohort since participants had different lengths of follow-up. Per 100 person years is equal to the percent of events that occurred during the observed time period of the study.|12 months prior to January 1, 2000 to June 30, 2008|Members of the IMS Life Link Health Plans Claims Database (containing data from >=90 managed healthcare plans, encompassing >=60 million lives) who had >=1 pharmacy claim during the study period. FSC participants were matched 1:2 to budesonide and montelukast separately, leading to different numbers analyzed for FSC dependent on cohort of interest.||Asthma related events per100 person year|||Number
840416|NCT01328964|Secondary|Mean Monthly Asthma-related Costs (Pharmacy and Medical) During the Post-index Period|The mean total asthma costs are a sum of pharmacy and medical costs. Costs were determined monthly from the pharmacy and medical encounters recorded in the managed care insurance database. All costs were summed for each participant over the 3-12 month follow-up period (post-index period), and a mean monthly cost was calculated by dividing by the follow-up for each participant.|12 months prior to January 1, 2000 to June 30, 2008|Members of the IMS Life Link Health Plans Claims Database (containing data from >=90 managed healthcare plans, encompassing >=60 million lives) who had >=1 pharmacy claim during the study period. FSC participants were matched 1:2 to budesonide and montelukast separately, leading to different numbers analyzed for FSC dependent on cohort of interest.||United States dollars||Standard Deviation|Mean
840417|NCT01328964|Primary|Number of Asthma-related Hospitalizations, Asthma-related Emergency Department (ED) Visits, and Combined Hospitalizations/ED Visits Represented Per 100 Person Years|The number of participants with an asthma-related event was computed during the follow-up period and was standardized by dividing by the total days of follow-up in each cohort since participants had different lengths of follow-up. Per 100 person years is equal to the percent of events that occurred during the observed time period of the study.|January 1, 2000 to June 30, 2008|Members of the IMS Life Link Health Plans Claims Database (containing data from >=90 managed healthcare plans, encompassing >=60 million lives) who had >=1 pharmacy claim during the study period. FSC participants were matched 1:2 to budesonide and montelukast separately, leading to different numbers analyzed for FSC dependent on cohort of interest.||asthma events per 100 person years|||Number
840418|NCT01329029|Secondary|Change From Baseline in Body Mass Index (BMI)|Body mass index (BMI) is a measure of body fat based on height and weight. Least Square Means was from an ANCOVA model including LOCF.|Baseline and Week 52|Participants from the Safety Population, all randomized participants who received at least one dose of study drug, with data available for analysis.||kg/m^2||Standard Error|Least Squares Mean
840419|NCT01329029|Secondary|Change From Baseline in Body Weight|Least Square Means was from an ANCOVA model including Last Observation Carried Forward (LOCF).|Baseline and Week 52|Participants from the Safety Population, all randomized participants who received at least one dose of study drug, with data available for analysis.||kilogram (kg)||Standard Error|Least Squares Mean
840420|NCT01329029|Secondary|Percentage of Participants Who Experienced at Least 1 Treatment Emergent Adverse Event (TEAE)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|52 Weeks|Safety Population included all randomized participants who received at least one dose of study drug.||percentage of participants|||Number
840421|NCT01329029|Secondary|Time to Trial Withdrawal Due to an Adverse Event|Time to event will be calculated as date of onset of event — date of first intake of double-blind study drug + 1 day.|52 Weeks (some participants extended treatment beyond 52 Weeks and are included in the analysis)|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with events.||days||Full Range|Median
840422|NCT01329029|Secondary|Time to First Hospitalisation Due to Any Cause During the Treatment Period|Time to event will be calculated as date of onset of event — date of first intake of double-blind study drug + 1 day.|52 Weeks (some participants extended treatment beyond 52 Weeks and are included in the analysis)|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with events.||days||95% Confidence Interval|Median
840423|NCT01329029|Secondary|Percentage of Participant With All-Cause Hospitalisation During the Treatment Period|Percentage of patients with at least one hospital admission due to any cause.|52 Weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.||percentage of participants|||Number
840424|NCT01329029|Secondary|Time to First Major Adverse Cardiovascular Event (MACE) During the Treatment Period|Composite MACE is a combined endpoint(cardiovascular death [including death due to undetermined cause], nonfatal myocardial infarction, and nonfatal stroke). Time to event was calculated as date of onset of event — date of first intake of double-blind study drug + 1 day.|52 Weeks (some participants extended treatment beyond 52 Weeks and are included in the analysis)|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized.||days||Full Range|Median
840425|NCT01329029|Secondary|Percentage of Participants With Major Adverse Cardiovascular Event (MACE) During the Treatment Period|Composite MACE is a combined endpoint (cardiovascular death [including death due to undetermined cause], nonfatal myocardial infarction, and nonfatal stroke).|52 Weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.||percentage of participants|||Number
840426|NCT01329029|Secondary|Time to Withdrawal Due to COPD Exacerbation During the Treatment Period|Time to event will be calculated as date of onset of event — date of first intake of double-blind study drug + 1 day.|52 Weeks (some participants extended treatment beyond 52 Weeks and are included in the analysis)|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized.||days||Full Range|Median
840427|NCT01329029|Secondary|Time to Withdrawal During the Treatment Period|Time to event will be calculated as date of onset of event — date of first intake of double-blind study drug + 1 day.|52 Weeks (some participants extended treatment beyond 52 Weeks and are included in the analysis)|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized.||days||Full Range|Median
840460|NCT01335724|Secondary|Neck Disability Index|"Neck Disability Index total score. Minimum = 0 Best. Maximum = 50 Worst"|96h|||Total Score||Standard Deviation|Mean
840461|NCT01335724|Secondary|Pain at Rest|"Pain at Rest on a 100 mm visual analog scale. Minimum score =0 mm no pain. Maximum score =100 mm extreme pain."|96h|||mm||Standard Deviation|Mean
840429|NCT01329029|Secondary|Time to Mortality Due to Any Reason During the Treatment Period Score|Time to event will be calculated as date of onset of event — date of first intake of double-blind study drug + 1 day.|52 Weeks (some participants extended treatment beyond 52 Weeks and are included in the analysis)|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized.||days||Full Range|Median
840430|NCT01329029|Secondary|Percentage of Participants With Improvement in CAT|Participants completed the CAT questionnaire at Baseline and after 52 Weeks of treatment. The CAT questionnaire measures the impact of COPD on wellbeing and daily life. Participants answer 8 questions on a scale from 0 (best) to 5 (worst). The total score ranges from 0 to 40 with higher scores indicating more impact. Improvement was defined as a CAT Total Score reduction from Baseline > 1.6.|Baseline and Week 52|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.||percentage of participants|||Number
840431|NCT01329029|Secondary|Change From Baseline in COPD Assessment Test (CAT) Total Score|Participants completed the CAT questionnaire at Baseline and after 52 Weeks of Treatment. The CAT questionnaire measures the impact of COPD on wellbeing and daily life. Participants answer 8 questions on a scale from 0 (best) to 5 (worst). The total score ranges from 0 to 40 with higher scores indicating more impact. A negative change from Baseline indicates improvement. Least-squares means from ANCOVA including treatment by time interaction.|Baseline and Week 52|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.||score on a scale||Standard Error|Mean
840432|NCT01329029|Secondary|Percentage of Rescue Medication-Free Days|Participants recorded their use of rescue medication in a daily diary. The percentage of days without rescue medication use.|52 Weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.||percentage of days||Standard Deviation|Mean
840433|NCT01329029|Secondary|Percentage of Symptom-Free Days|Symptoms of COPD (cough, sputum) were recorded in a daily diary. The percentage of days without symptoms is reported.|52 Weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.||percentage of days||Standard Deviation|Mean
840434|NCT01329029|Secondary|Change From Baseline in COPD Symptom Score From Daily Diary|Participants recorded COPD symptoms cough and sputum production in a daily diary. Cough was assessed using a 4-point scale where 0=No cough to 3=severe cough and sputum was assessed using a 4-point scale where 0=no sputum production to 3=severe sputum production. Least-squares means from ANCOVA including treatment by time interaction. A negative change from Baseline indicates improvement. Total symptom score is the sum of cough and sputum scores, ranging from 0 (best possible outcome) to 6 (worst possible outcome).|52 weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.||score on a scale||Standard Error|Least Squares Mean
840435|NCT01329029|Secondary|Change From Baseline in Use of Rescue Medication From Daily Diary|Salbutamol metered dose inhaler was available as rescue medication during the study. The participant recorded the use of rescue medication in a daily diary. A negative change from Baseline indicates an improvement.|Baseline and Week 52|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data included in the repeated measurements analysis.||puffs per day||Standard Error|Least Squares Mean
840436|NCT01329029|Secondary|Change From Baseline in Post-Bronchodilator FEV1/FVC|The FEV1/FVC ratio represents the percentage of vital capacity expelled from the lungs during the first second of a forced exhalation. Pulmonary function testing was performed using centralized spirometry. A positive change from Baseline indicates improvement.|52 weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.||percent||Standard Deviation|Mean
840437|NCT01329029|Secondary|Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in the First 6 Seconds (FEV6)|FEV6 is the amount of air which can be forcibly exhaled from the lungs in the first six seconds of a forced exhalation. Pulmonary function testing was performed using centralized spirometry. A positive change from Baseline indicates improvement.|52 weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.||liters||Standard Error|Least Squares Mean
840438|NCT01329029|Secondary|Change From Baseline in Post-Bronchodilator Forced Expiratory Flow at 25% to 75% of Vital Capacity (FEF25-75%)|Forced expiratory flow 25-75% (FEF25-75%) is the flow (or speed) of air coming out of the lung during the middle half of a forced expiration. Pulmonary function testing was performed using centralized spirometry. Least-squares means was from ANCOVA including treatment by time interaction. A positive change from Baseline indicates improvement.|52 weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.||liters/second||Standard Error|Least Squares Mean
840439|NCT01329029|Secondary|Change From Baseline in Post-Bronchodilator Forced Vital Capacity (FVC)|Forced vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Least-squares means was from ANCOVA including treatment by time interaction. A positive change from Baseline indicates improvement.|52 weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.||liters||Standard Error|Least Squares Mean
840462|NCT01335724|Primary|Pain on Movement|"Pain on movement on a 100 mm visual analog scale. Minimum score =0 mm no pain. Maximum score =100 mm extreme pain."|48 h|||mm||Standard Deviation|Mean
840516|NCT01336712|Secondary|Disease Free Survival (DFS) Percentage||2 year|||percentage of patients analyzed|||Number
840517|NCT01336712|Secondary|Percentage of Participatns With Donor Chimerism Post-transplant|Characterize donor hematopoietic chimerism in peripheral blood at day 30 after HSCT.|Day 30|||percentage of patients|||Number
840440|NCT01329029|Secondary|Duration of Moderate or Severe COPD Exacerbations Per Participant|A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient’s baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management.|52 Weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis. n in each of the categories is the number of participants with exacerbations.||days||Standard Deviation|Mean
840441|NCT01329029|Secondary|Number of Moderate or Severe COPD Exacerbation Days|A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient’s baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management. The number of exacerbation days per patient is the sum of durations (stop date of exacerbation — start date of exacerbation + 1) of all exacerbations within the category.|52 Weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.||days||Standard Deviation|Mean
840442|NCT01329029|Secondary|Number of Patients Needed to Treat to Avoid 1 Moderate or Severe COPD Exacerbation Derived From Exacerbation Per Patient Per Year|The number needed to treat (NNT) analysis is a simple, concise method to quantify directly the benefits that alternative treatment options have on disease outcomes in terms of the number of patients who need to be treated before a benefit is observed. Risk reduction: Rate(Placebo)— Rate (Roflumilast 500 μg), Number needed to treat for benefit (NNTB): 1/(Risk reduction). A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient's baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management. COPD exacerbations were categorized as Severe: Requiring hospitalization and/or leading to death; Moderate: Requiring oral or parenteral glucocorticosteroid therapy.|52 Weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.||participants|||Number
840443|NCT01329029|Secondary|Time to Third Moderate or Severe COPD Exacerbation|Time to event was calculated as date of onset of event — date of first intake of double-blind study drug + 1 day for events: moderate or severe. A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient’s baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management. COPD exacerbations were categorized as Severe: Requiring hospitalization and/or leading to death; Moderate: Requiring oral or parenteral glucocorticosteroid therapy.|52 Weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized.||days||Full Range|Median
840444|NCT01329029|Secondary|Time to Second Moderate or Severe COPD Exacerbation|Time to event was calculated as date of onset of event — date of first intake of double-blind study drug + 1 day for events: moderate or severe. A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient’s baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management. COPD exacerbations were categorized as Severe: Requiring hospitalization and/or leading to death; Moderate: Requiring oral or parenteral glucocorticosteroid therapy.|52 Weeks (some participants extended treatment beyond 52 Weeks and are included in the analysis)|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized.||days||95% Confidence Interval|Median
840445|NCT01329029|Secondary|Time to First COPD Exacerbation All Categories|Time to event was calculated as date of onset of event — date of first intake of double-blind study drug + 1 day for all events: mild, moderate or severe. A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient’s baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management.|52 Weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized.||days||95% Confidence Interval|Median
840446|NCT01329029|Secondary|Percentage of Participants Experiencing at Least 1 COPD Exacerbation|A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient’s baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management.|52 weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.||percentage of participants|||Number
840447|NCT01329029|Secondary|Rate of COPD Exacerbations Per Patient Per Year All Categories|A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient’s baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management. COPD exacerbations were categorized as follows: Severe=Requiring hospitalization and/or leading to death; Moderate=Requiring oral or parenteral glucocorticosteroid therapy. The defined number of days a patient was in the trial was divided by 365.25, in order to express the duration as a fraction of 1 year.|52 weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.||exacerbations per patient per year||95% Confidence Interval|Mean
840448|NCT01329029|Secondary|Rate of Severe COPD Exacerbations Per Patient Per Year|A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient’s baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management. Severe COPD exacerbations were categorized as requiring hospitalization and/or leading to death. The defined number of days a patient was in the trial was divided by 365.25, in order to express the duration as a fraction of 1 year.|52 weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.||exacerbations per patient per year||95% Confidence Interval|Mean
840518|NCT01336712|Secondary|Survival|To obtain estimate of overall survival (OS)|2 year|||percentage of patients analyzed|||Number
840449|NCT01329029|Secondary|Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in the First Second (FEV1)|Pulmonary function testing was performed using centralised spirometry. FEV1 is the maximum amount of air that can be forcefully exhaled in one second. Least-squares means is from Analysis of Covariance (ANCOVA) including treatment by time interaction. A positive change from Baseline indicates improvement.|Baseline and Week 52|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.||liters||Standard Error|Least Squares Mean
840450|NCT01329029|Primary|Rate of Moderate or Severe COPD Exacerbations Per Patient Per Year|A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient’s baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management. COPD exacerbations were categorized as follows: Severe=Requiring hospitalization and/or leading to death; Moderate=Requiring oral or parenteral glucocorticosteroid therapy. The defined number of days a patient was in the trial was divided by 365.25, in order to express the duration as a fraction of 1 year.|52 weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.||exacerbations per patient per year||95% Confidence Interval|Mean
840451|NCT01335542|Primary|"The Primary Outcome is Time Until a Patient is Ready for Discharge."|"The primary outcome is time until a patient is ready for discharge. Discharge criteria are:
PCA (if present) has been discontinued
Not experiencing moderate or severe nausea (within last 4 hours).
Solid food diet
Able to urinate (Foley catheter removed)
Pain: NRS <4.
Surgical wound dry
No acute medical problems
Physical Therapy Criteria
Independently transfer from supine to sit, from sitting to standing
Ambulate 40 ft. without assistance
Extension range of motion (< 10 degrees)"|Participants will be followed for the duration of their hospital stay, an expected average of 3 days|||days||Inter-Quartile Range|Mean
840452|NCT01335698|Secondary|Number of Participants With Emergent Genotypic Substitutions|Newly emergent substitutions are on-treatment substitutions that were not detected at baseline.Viral rebound in the resistance analysis was defined as: Less than a 1 log10 drop from baseline in plasma HIV RNA level by Week 16, confirmed by a second plasma HIV RNA level redrawn within 2 and 4 weeks from original sample. Or, a plasma HIV RNA level >200 c/mL after Week 24, confirmed by a second plasma HIV RNA level redrawn within 2 and 4 weeks from original sample. Or, repeated plasma HIV RNA level ≥50 c/mL after Week 48. Viral rebound was defined as a plasma HIV RNA level ≥400 c/mL at any time in a patient who had previously achieved a plasma HIV RNA level <50 c/mL. Or, a plasma HIV RNA level ≥50 c/mL and <1,000 c/mL followed by a return to virologic suppression was considered a viral blip and not a viral rebound. NRTI=nucleoside reverse transcriptase inhibitor|Baseline through Week 48|All participants with virologic failure.||Participants|||Number
840453|NCT01335698|Secondary|CD4 Cell Count Changes From Baseline|Last observation carried forward: missing values are replaced with the last on-treatment value in the previous visit window;if a patient does not have an on-treatment value, baseline value is carried forward. Baseline observation carried forward: missing values are replaced with the baseline value; if a patient does not have a baseline the first on-treatment value is carried forward.|Baseline to Weeks 24 and 48|All participants with both baseline and time point results||Cells/mm^3||Standard Error|Mean
840454|NCT01335698|Primary|Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality|Criteria of the Division of AIDS for grading the severity of adult and pediatric adverse events as follows: Grade (Gr) 1=mild; Gr 2=moderate; Gr 3=severe; Gr 4=potentially life-threatening. Neutrophils (absolute) (adult and infants >7 days): Gr 1=1.000-1300/mm^3; Gr 2=750-999 mm^3; Gr 3=500-749 mm^3; Gr 4= <500 mm^3. Alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase: Gr 1=1.25-2.5*upper limit of normal (ULN); Gr 2=2.6-5.0*ULN; Gr 3=5.1-10.0*ULN; Gr 4= >10.0*ULN. Bilirubin, total (adults and infants >14 days): Gr 1=1.1-1.5*ULN; Gr 2=1.6-2.5*ULN; Gr 3=2.6-5.0*ULN; Gr 4= >5.0*ULN. Lipase: Gr 1=1.1-1.5*ULN; Gr 2=1.6-3.0*ULN; Gr 3=3.1-5.0*ULN; Gr 4= >5.0*ULN. Bicarbonate, serum low: Gr 1=16.0 mEq/L-<lower limit of normal; Gr 2=11.0-15.9 mEq/L; Gr 3=8.0-10.9 mEq/L; Gr 4= <8 mEq/L. By criteria of the World Health Organization: Amylase: Gr 1=1.0-1.39*ULN; Gr 2=1.40-2.09*ULN; Gr 3.=2.10-5.0*ULN; Gr 4= >5.0*ULN.|Day 1 of treatment through Week 48|All participants who received at least 1 dose of study drug. n=number of participants evaluable||Participants|||Number
840455|NCT01335698|Primary|Number of Participants With A Center of Disease Control and Prevention (CDC) Class C AIDS Event|The CDC disease staging system assesses the severity of HIV disease by CD4 cell counts and by the presence of specific HIV-related conditions. CD4 counts are classified as 1: ≥500 cells/µL, 2: 200-499 cells/µL, and 3: <200 cells/µL. Children with HIV infection are also classified in each of several categories. Category N: Not symptomatic. Category A: Mildly symptomatic. Category B: Moderately symptomatic. Category C: Severely symptomatic.|Day 1 of treatment through Week 48|All participants who received at least 1 dose of study drug.||Participants|||Number
840456|NCT01335698|Primary|Number of Participants Who Died and With Adverse Events (AEs) Leading to Discontinuation, Hyperbilirubinemia, Jaundice, First-degree Arterioventricular Block, Tachycardia, and Rash|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment.|Day 1 of treatment through Week 48|All participants who received at least 1 dose of study drug||Participants|||Number
840457|NCT01335698|Secondary|CD4 Percent Changes From Baseline||Baseline to Weeks 24 and 48|All participants with both baseline and time point results; n=number of participants evaluable at time point||Percent change||Standard Error|Mean
840458|NCT01335698|Secondary|HIV RNA Changes From Baseline||Baseline to Weeks 24 and 48|All participants who received at least 1 dose of study drug. n=participants with both baseline and time point results||Log copies per millileter||Standard Error|Mean
840459|NCT01335698|Secondary|Number of Participants With HIV RNA <50 Copies/mL and <400 Copies/mL in the Week 24 Atazanavir Powder Cohort and the Eligible Week 48 Atazanavir Powder Cohort|Virologic success includes patients with HIV RNA <50 copies/mL. Two cohorts were assess: The Atazanavir Powder Cohort=patients who received treatment and did not switch to capsule before analysis Week 24 or before their HIV RNA Week 24 assessment, and the Eligible Week 48 Atazanavir Powder Cohort=patients who initiated study treatment at least 48 weeks before last person last visit and did not switch to capsule before analysis Week 48 or before their HIV RNA Week 48 assessment.|Day 1 of treatment to Weeks 24 and 48|For efficacy of atazanavir powder to Week 24: Atazanavir Powder Cohort. For efficacy of atazanavir powder efficacy to Week 48 (n): Eligible Week 48 Atazanavir Powder Cohort||Participants|||Number
840463|NCT01335750|Primary|Corneal Staining Area|Analysis of staining area was performed by averaging the values from the five regions for each eye and then identifying the subject's worse eye at each visit. Mean total area was calculated from all identified eyes for each visit.|Baseline, 2 Hour Period, 4 Hour Period|Analysis of staining area was performed by averaging the values from the five regions for each eye and then identifying the subject's worse eye at each visit. Mean total area was calculated from all identified eyes for each visit.||units on a scale||Standard Deviation|Mean
840464|NCT01335750|Primary|Corneal Staining Severity|Severity of staining was recorded for each region using a scale of 0-none to 4-patch >/=1mm. Analysis of staining was performed by averaging the scores from the five regions for each eye, then identifying the subject's worse eye at each visit. Mean total severity was calcuated from all identified eyes for each visit.|Baseline, 2 Hour Period, 4 Hour Period|Severity of staining was recorded for each region using a scale of 0-none to 4-patch >/=1mm. Analysis of staining was performed by averaging the scores from the five regions for each eye, then identifying the subject's worse eye at each visit. Mean total severity was calcuated from all identified eyes for each visit.||units on a scale||Full Range|Mean
840465|NCT01335750|Secondary|Subjective Dryness|Subjective dryness ratings 0-100 (0=extremely dry, 100=extremely moist)|Visit 1: Baseline; Visit 2: 2 hours, Visit 3: 4 hours|Subjective dryness ratings 0-100 (0=extremely dry, 100=extremely moist)||units on a scale||Standard Deviation|Mean
840466|NCT01335750|Secondary|Subjective Comfort|Subjective comfort ratings 0-100 (0=causes pain, 100=excellent comfort)|Visit 1: Baseline; Visit 2: 2 hours, Visit 3: 4 hours|Subjective comfort ratings 0-100 (0=causes pain, 100=excellent comfort)||units on a scale||Standard Deviation|Mean
840467|NCT01335789|Primary|Stress (as Measured by Subjective Report)|Subjective report of stress was measured using a 0-10 Likert Scale (0=not at all, 10=extremely). Reported here is subjective stress level 5 minutes following exposure to the Trier Social Stress Task (approximately 60 minutes post study drug/placebo administration). Trier Social Stress Task is a psychosocial laboratory stress task in which subjects deliver a speech and perform a math problem in front of a stranger audience.|5 minutes following Trier Social Stress Task completion|||units on a scale||95% Confidence Interval|Mean
840468|NCT01335789|Secondary|Craving (as Measured by the Marijuana Craving Questionnaire)|The MCQ is intended to measure marijuana craving in adults. It measures symptoms on four subscales: expectancy, purposefulness, emotionality, and compulsivity. The scale rates individual items from 1–7 with a composite scoring range of 12-84 and possible subscale scoring range of 3-21. Reported here is MCQ composite score 5 minutes following Trier Social Stress Task exposure (approximately 60 minutes post study drug/placebo administration). Trier Social Stress Task is a psychosocial laboratory stress task in which subjects deliver a speech and perform a math problem in front of a stranger audience.|5 minutes following Trier Social Stress Task completion|||units on a scale||95% Confidence Interval|Mean
840469|NCT01335789|Primary|Stress (as Measured by Cortisol)|Salivary cortisol samples were collected via passive drool to provide empirical assessment of stress reactivity. Reported here is salivary cortisol level 5 minutes following Trier Social Stress Task exposure (approximately 60 minutes post study drug/placebo administration). Trier Social Stress Task is a psychosocial laboratory stress task in which subjects deliver a speech and perform a math problem in front of a stranger audience.|5 minutes following Trier Social Stress Task completion|||nmol/L||95% Confidence Interval|Mean
840470|NCT01335932|Secondary|Functional Assessment|Patient survey|at 1 and 180 days post-randomization||||||
840471|NCT01335932|Secondary|Safety|"Number and severity of AEs and SAEs as defined in the Adverse Event section of the protocol
Time to neutropenia (absolute neutrophil count [ANC] < 1000, <500 per mm3)
Use of G-CSF
Time to renal insufficiency (creatinine clearance < 60, < 30 ml/min)
Time to thrombocytopenia (platelet count < 50,000, < 20,000 per mm3)
Number of red cell and platelets products between randomization and day 35 after randomization"|by 35 days post-randomization||||||
840472|NCT01335932|Secondary|CMV Disease|Need to be biopsy-proven|by 180 days post-randomization||||||
840473|NCT01335932|Secondary|Length of Stay|"ICU (days alive and not in the ICU by day 28)
Hospital (days alive and not hospitalized by day 28 and 180)"|by 28 and 180 days post-randomization||||||
840474|NCT01335932|Secondary|Clinical Outcomes|"Organ system failure at 14 and 28 days
Duration of mechanical ventilation (as assessed by ventilator days and ventilator-free days alive)
Lung injury score
Bacteremia and/or fungemia
Mortality at 60 and 180 days after randomization
Composite of survival status, ventilation status, and IL-6 levels
Subset analysis of laboratory and clinical outcomes amongst subjects who survive at least 7 days after randomization
Subset analysis of laboratory and clinical outcomes amongst subjects who are mechanically ventilated for at least 7 through 14 days after randomization"|at 7, 14, 28, 60, and 180 days post-randomization||||||
840475|NCT01335932|Secondary|Additional Cytokine Levels|"Additional cytokines with proven association with ALI and CMV will be compared between the groups.
BAL levels of IL-6, IL-8, TNF-alpha & TGF-β
Plasma IL-6, IL-8, IL-10, TNF-alpha & soluble ICAM-1
Cytokines will be analyzed at each time point and over time (area under the curve), and peak levels will be compared between randomization and Day 28 (end of treatment)."|at 7 and 28 days post-randomization||||||
840476|NCT01335932|Secondary|Incidence of CMV Reactivation at 28 Days (Blood, Throat)|"The following virologic parameters will be compared between the groups:
Time to CMV reactivation at any level
Time to > 1,000 copies per mL
Time to > 10,000 copies per mL
Area under the curve
Peak viral load
Initial viral load"|at 28 days post-randomization||||||
840477|NCT01335932|Primary|Serum IL-6 Level|Change between baseline and 14 days post-randomization between placebo & ganciclovir groups|Baseline and Day 14|||pg/mL||Standard Deviation|Mean
840478|NCT01335971|Secondary|Fold-change in Plasma Inflammatory Marker Concentrations (Follow-up to Baseline)|Inflammatory markers were measured in plasma at baseline and 4 weeks. Thiobarbituric acid reactive substances were measured in nmol malondialdehyde (MDA)/mL.|Baseline and 4 weeks|Number of participants analyzed is based on number of participants that had plasma samples available. Samples were missing for one participant in the 25 micromole group.||fold change||Inter-Quartile Range|Median
840490|NCT01336023|Secondary|Mean Actual Daily Insulin Dose|Mean of the actual doses recorded at visit 28 (Week 26).|Week 26|The FAS included all randomised subjects. Missing data was imputed using LOCF. For 34 subjects, the dose values were missing hence did not contribute to the analysis. The comparison was made between the insulin products IDeg and IDeglira.||units||Standard Deviation|Mean
840479|NCT01335971|Secondary|Fold-change in Inflammatory Marker Concentrations in Bronchial Alveolar Lavage (Follow-up to Baseline) by Treatment Group|Inflammatory markers were measured in bronchial alveolar lavage samples at baseline and 4 weeks in the participants of this trial who had bronchoalveolar lavage samples obtained.Three participants - one from each treatment group - were unable to complete follow-up bronchoalveolar lavage.|Baseline and 4 weeks|Number of participants analyzed is based on number of participants that had bronchial alveolar lavage samples available. Samples were missing for two participants in the placebo group.||fold change||Inter-Quartile Range|Median
840480|NCT01335971|Secondary|Fold-change in Serum Inflammatory Marker Concentrations (Follow-up to Baseline)|Inflammatory markers were measured in serum samples derived from venipuncture at baseline and 4 weeks in the serum of the participants of the trial.|Baseline and 4 weeks|Number of participants analyzed is based on number of participants that had plasma samples available. Samples were missing for one participant in the 25 micromole group.||fold change||Inter-Quartile Range|Median
840481|NCT01335971|Secondary|Fold-change in Isoprostane Concentrations (Follow-up to Baseline)|Isoprostane, an oxidant stress indicator, was measured in expired breath condensate at baseline and 4 weeks.|Baseline and 4 weeks|Number of participants analyzed based on number of individuals with expired breath condensate samples in which testing could be successfully performed. Samples were missing for two participants in the 25 micromole group and one participant in the 150 micromole group.||fold change||Inter-Quartile Range|Median
840482|NCT01335971|Primary|Change From Baseline in Bronchial Epithelial Cell Expression of AKR1C3 at 4 Weeks|The sixth primary design variable is the change from baseline in expression of Aldo-Keto Reductase Family 1 Member C3 (AKR1C3) in bronchial epithelial cells (BEC) at 4 weeks. Three participants - one from each treatment group - were unable to complete follow-up bronchoalveolar lavage for primary outcome data.|Baseline and 4 weeks|Number of participants analyzed based on number of individuals with bronchial epithelial samples in which assays could be successfully performed. Assays failed for two participants in the placebo group, one participant in the 25 micromole group, and one participant in the 150 micromole group.||fold change||Inter-Quartile Range|Median
840483|NCT01335971|Primary|Change From Baseline in Bronchial Epithelial Cell Expression of AKR1C1 at 4 Weeks|The fifth primary design variable is the change from baseline in expression of Aldo-Keto Reductase Family 1 Member C1 (AKR1C1) in bronchial epithelial cells (BEC) at 4 weeks. Three participants - one from each treatment group - were unable to complete follow-up bronchoalveolar lavage for primary outcome data.|Baseline and 4 weeks|Number of participants analyzed based on number of individuals with alveolar macrophage samples in which assays could be successfully performed. Assays failed for two participants in the placebo group and two in the 150 micromole group.||fold change||Inter-Quartile Range|Median
840484|NCT01335971|Primary|Change From Baseline in Bronchial Epithelial Cell Expression of HO1 at 4 Weeks|The fourth primary design variable is the change from baseline in expression of Heme Oxygenase 1 (HO1) in bronchial epithelial cells (BEC) at 4 weeks. Three participants - one from each treatment group - were unable to complete follow-up bronchoalveolar lavage for primary outcome data.|Baseline and 4 weeks|Number of participants analyzed based on number of individuals with bronchial epithelial samples in which assays could be successfully performed. Assays failed for one participant in the placebo group.||fold change||Inter-Quartile Range|Median
840485|NCT01335971|Primary|Change From Baseline in Bronchial Epithelial Cell Expression of NQ01 and Keap1 at 4 Weeks|The third primary design variable is the change from baseline in NAD(P)H Quinone Dehydrogenase 1 (NQ01) and Kelch Like ECH Associated Protein 1 (Keap1) expression in bronchial epithelial cells (BEC) at 4 weeks. Three participants - one from each treatment group - were unable to complete follow-up bronchoalveolar lavage for primary outcome data.|Baseline and 4 weeks|Number of participants analyzed based on number of individuals with bronchial epithelial samples in which assays could be successfully performed. Assays failed for two participants in the placebo group and one in the 150 micromole group.||fold change||Inter-Quartile Range|Median
840486|NCT01335971|Primary|Change From Baseline in Bronchial Epithelial Cell Expression of Nrf2 at 4 Weeks|The second primary design variable is the change from baseline in nuclear factor erythroid 2 like 2 (Nrf2) expression in bronchial epithelial cells (BEC) at 4 weeks by analysing Nrf2 protein. Three participants - one from each treatment group - were unable to complete follow-up bronchoalveolar lavage for primary outcome data.|Baseline and 4 weeks|Number of participants analyzed based on number of individuals with bronchial epithelial samples in which assays could be successfully performed. Assays failed for one participant in the placebo group and one in the 25 micromole group..||fold change||Inter-Quartile Range|Median
840487|NCT01335971|Primary|Change From Baseline in Alveolar Macrophage Expression of Nrf2 and Associated Genes at 4 Weeks|The first primary design variable is the change from baseline in nuclear factor erythroid 2 like 2 (Nrf2) expression in alveolar macrophages (AM) at 4 weeks by analysing Nrf2 protein and expression of a panel of Nrf2 regulated genes.Three participants - one from each treatment group - were unable to complete follow-up bronchoalveolar lavage for primary outcome data.|Baseline and 4 weeks|Number of participants analyzed based on number of individuals with alveolar macrophage samples in which assays could be successfully performed. Assays failed for two participants in the placebo group, one in the 25 micromole group, and one in the 150 micromole group.||fold change||Inter-Quartile Range|Median
840488|NCT01335997|Secondary|Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) Blood Levels|Due to study termination caused by the decision to stop the development of the combination tablet, sufficient data were not available to perform the planned efficacy analysis, which is based on the cross-over data collected in period II and III.|Baseline and Week 12 and Week 20|Completers Population - participants that completed the study, have respective endpoint data available at baseline, end of period II and end of period III and were not off study drug more than 3 days prior to their period II and period III observations.|||||
840489|NCT01335997|Primary|Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) Blood Levels|Due to study termination caused by the decision to stop the development of the combination tablet, sufficient data were not available to perform the planned efficacy analysis, which is based on the cross-over data collected in period II and III.|Baseline and Week 12 and Week 20|Completers Population - participants that completed the study, have respective endpoint data available at baseline, end of period II and end of period III and were not off study drug more than 3 days prior to their period II and period III observations.|||||
840491|NCT01336023|Secondary|Change From Baseline in Incremental Area Under the Curve 0-4h (iAUC0-4h) Derived From the Glucose Concentration Profile During Meal Test|Values of mean change in normalised iAUC0-4h values based on LOCF data derived from the glucose concentration profiles during a meal test. The meal test was performed at selected sites at baseline and after 26 weeks of treatment in the main trial period. The incremental AUC was calculated using the trapezoidal method and the resulting area was divided length of the observation period to yield the (normalised) prandial increment in mmol/L using the available valid glucose observations and the associated actual elapsed time point.|Week 0, Week 26|The number of subjects analysed were equal to study population in which the meal test was perfomed at selected sites. The subjects in each arm were 63, 128 and 61 at week 26. Missing data was imputed using LOCF.||mmol/L||Standard Deviation|Mean
840492|NCT01336023|Secondary|Number of Hypoglycaemic Episodes|Reported hypoglycemaic episodes are number of hypoglycemic events per 100 patient years of exposure.|Weeks 0-26|The Safety Analysis Set (SAS) included all subjects receiving at least one dose of the investigational product or comparators. The missing data was imputed using LOCF. Three subjects did not have their case book signed off due to discontinuation of an investigator’s participation in the trial; hence 1 subject from each arm was excluded from the SAS||Events per 100 patient years of exposure|||Number
840493|NCT01336023|Secondary|Mean Change From Baseline in Body Weight at Week 26|Values of mean change in body weight.|Week 0, Week 26|The FAS included all randomised subjects and missing data was imputed using LOCF. Three subjects did not have their case book signed off due to discontinuation of an investigator’s participation in the trial; hence 1 subject from each arm was excluded from the FAS.||kg||Standard Deviation|Mean
840494|NCT01336023|Primary|Mean Change From Baseline in HbA1c (Glycosylated Haemoglobin) at Week 26.|Values of mean change in HbA1c.|Week 0, week 26|The FAS included all randomised subjects and missing data was imputed using LOCF. Three subjects did not have their case book signed off due to discontinuation of an investigator’s participation in the trial; hence 1 subject from each arm was excluded from the FAS.||Percentage of glycosylated haemoglobin||Standard Deviation|Mean
840495|NCT01336140|Secondary|Patients With Recorded Aminophylline Related Major Adverse Events|Aminophylline related adverse effects include: systemic hypotension (systolic blood pressure < 90 mmHg), any thachyarrhythmia (ventricular or supraventricular) and seizure.|Within 24 hours from the intervention.|All patients.||participant|||Number
840496|NCT01336140|Secondary|Global Symptom Score (GSS) of Regadenoson Related Adverse-effects|"GSS is the sum of severity-weighted (0 = none, 1 = mild, 2 = moderate, 3 = severe) regadenosnon-related adverse-effects of flushing, feeling hot, chest pain, chest discomfort, angina, headache, dizziness, abdominal cramps or discomfort, diarrhea, nausea.
GSS is calculated by weighting each side effect from 0 - 3 (as above) then add the severity weighted scores of all adverse effects (total of 10 as above).
The number of adverse effects contributing to the score is 10, each has a potential severity weight of 0 (absent) to 3 (severe). Thus:
Minimum possible Global Symptom Score (GSS) = 0 Maximum possible Global Symptom Score (GSS) = 30"|Within 2 hours from the intervention.|All patients.||Global Symptom Score||Standard Deviation|Mean
840497|NCT01336140|Secondary|Number of Patients With Any (One or More) Regadenoson-related Adverse-effect|"Regadenoson-related adverse-effects include: flushing, feeling hot, chest pain, chest discomfort, angina, headache, dizziness, abdominal cramps or discomfort, diarrhea, nausea.
When multiple adverse effects are reported, only one event is counted."|Within 2 hours from the intervention.|All patients.||Participants|||Number
840498|NCT01336140|Primary|Diarrhea (as Reported by the Patient)|"Number of patients who report any incident of diarrhea. Patients will be surveyed for incidents of diarrhea following to the completion of the cardiac stress testing procedure and prior to discharge from the laboratory (typically within 2 hours from stress completion).
The primary endpoint encompasses the number of patients with reported symptoms of diarrhea, not the number of bowel movements."|Within 2 hours from the intervention|All patients.||participants|||Number
840499|NCT01336205|Primary|Incidence of Patients Experiencing Severe Adverse Events (SAEs)|The incidence of patients experiencing SAEs during the randomized treatment and follow-up periods was calculated.|Baseline (Week 0) to end of the follow-up period|The Safety analysis set included all randomized patients who received at least 1 dose of IP and patients who received Usual Care, with the exception of patients who were randomized multiple times within the program at different centers or patients who were randomized at sites where data integrity issues were identified.||Participants|||Number
840500|NCT01336205|Primary|Incidence of Patients Experiencing AEs That Resulted in Discontinuation of Investigational Product (IP)|The incidence of patients experiencing AEs that resulted in discontinuation of IP during the randomized treatment or follow-up periods was calculated.|Baseline (Week 0) to end of the follow-up period|The Safety analysis set included all randomized patients who received at least 1 dose of IP and patients who received Usual Care, with the exception of patients who were randomized multiple times within the program at different centers or patients who were randomized at sites where data integrity issues were identified.||Participants|||Number
840501|NCT01336205|Primary|Incidence of Patients Experiencing at Least One Adverse Event (AE)|The incidence of patients experiencing at least one AE during the randomized treatment and follow-up periods was calculated.|Baseline (Week 0) to end of the follow-up period|The Safety analysis set included all randomized patients who received at least 1 dose of IP and patients who received Usual Care, with the exception of patients who were randomized multiple times within the program at different centers or patients who were randomized at sites where data integrity issues were identified.||Participants|||Number
840502|NCT01336296|Secondary|Number of Patients Requiring Anti-lymphocyte Therapy for Acute Rejection||1 year|||participants|||Number
840503|NCT01336296|Secondary|Incidence of Chronic Alloantibody Rejection or Chronic Allograft Arteriopathy by Banff ‘97|The Banff features suggestive of chronic rejection were: a) chronic transplant glomerulopathy: Glomerular basement membrane duplication and mesangial cell proliferation, and b) vasculopathy: Fibrous intimal thickening often with fragmentation of internal elastic lamina. Chronic changes in the interstitium (ci), tubules (ct), vessels (cv), and glomerulus (cg) were likewise graded into 0, 1, 2, and 3. The severity of interstitial fibrosis and tubular atrophy, as also chronic transplant glomerulopathy and vasculopathy were used to grade chronic allograft changes.|1 year|||participants|||Number
840519|NCT01336712|Primary|Percentage of Patients Experiencing Hemorrhagic Cystitis Post Transplant|1.1 To estimate the incidence of BK virus-associated hemorrhagic cystitis following a TBI-based myeloablative haploidentical HSCT in patients with high risk hematologic malignancies.|6 months|||percentage of patients|||Number
840505|NCT01336296|Secondary|Severity of Acute Rejection by Banff '97 Criteria|"Severity of biopsy-confirmed acute rejection by Banff '97 Criteria (updated 2007) at 1 year. The acute form of T-cell mediated rejection is furthermore subclassified as follows. Since this is the most common form of rejection, it is useful to know:
As with humoral rejection, there are both acute & chronic forms:
The acute form of T-cell mediated rejection is furthermore subclassified as follows. Since this is the most common form of rejection, it is useful to know:
Class IA: there is at least 25% of parenchymal showing interstitial infiltration and foci of moderate tubulitis (defined as a certain number of immune cells present in tubular cross-sections).
Class IB: just like Class IA except there is more severe tubulitis.
Class IIA: there is mild-to-moderate intimal arteritis.
Class IIB: there is severe intimal arteritis comprising at least 25% of the lumenal area.
Class III: there is transmural (e.g. the full vessel wall thickness) arteritis."|Severity 1 year post transplant|||participants|||Number
840506|NCT01336296|Primary|Incidence of Biopsy-confirmed Acute Rejection by Banff '97 Criteria (Updated 2007) 3, 6 and 12 Months Post Transplant|"Incidence of biopsy-confirmed acute rejection by Banff '97 Criteria (updated 2007) post transplant. The acute form of T-cell mediated rejection is furthermore subclassified as follows. Since this is the most common form of rejection, it is useful to know:
As with humoral rejection, there are both acute & chronic forms:
The acute form of T-cell mediated rejection is furthermore subclassified as follows. Since this is the most common form of rejection, it is useful to know:
Class IA: there is at least 25% of parenchymal showing interstitial infiltration and foci of moderate tubulitis (defined as a certain number of immune cells present in tubular cross-sections).
Class IB: just like Class IA except there is more severe tubulitis.
Class IIA: there is mild-to-moderate intimal arteritis.
Class IIB: there is severe intimal arteritis comprising at least 25% of the lumenal area.
Class III: there is transmural (e.g. the full vessel wall thickness) arteritis."|3, 6 and 12 months post transplant|||participants|||Number
840507|NCT01336569|Primary|Mean Intraocular Pressure (IOP) Change at the Final Visit From Baseline (Prior Beta-blocker Monotherapy)|As measured by Goldmann applanation tonometry. High IOP (outside the normal range) can be a risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement.|Baseline, up to 6 weeks|Intent-to-Treat (ITT): All participants who received study medication and had at least one on-therapy study visit.||millimeters mercury (mmHg)||Standard Deviation|Mean
840508|NCT01336608|Secondary|Mean Number of Occasions Rescue Medication [Albuterol (Salbutamol)] Used During a 24-hour Period Averaged Over the Entire 24-week Treatment Period|Participants were given daily record cards for daily completion from BL (Week -1) through Week 24 (Visit 6) each morning and prior to taking study medication (i.e., single-blind and double-blind study medication) supplemental medication (albuterol [salbutamol] if received) and ipratropium bromide (if received). Participants recorded number of occasions supplemental albuterol/salbutamol (MDI and/or nebules) used over the previous 24 hours and any medical problems that they had experienced and any medication used to treat these medical problems over the previous 24 hours. Analysis was performed using an analysis of covarience (ANCOVA) model with covariates of treatment, BL mean of occasions of rescue medication use (Week -1), history of exacerbation, and geographical region.|BL (Week -1), Week 1 to Week 24|ITT Population: all randomized participants who received at least one dose of study medication. Only those participants with at least 1 on treatment rescue medication measurement during the treatment period and without missing covariate information were analyzed.||Occasions per 24 hours||Standard Error|Least Squares Mean
840509|NCT01336608|Secondary|Change From BL in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) FEV1 at Day 168|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. Trough FEV1 measurements were taken electronically by spirometry at Screening, Days 1, 28, 84, 126, and 168. BL FEV1 was defined as the mean of the assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1. Trough FEV1 was defined as the mean of the FEV1 values obtained 24 hours after previous morning's dosing. Change from BL was calculated as the average at each visit minus the BL value. Analysis was preformed using a repeated measures model with covariates of visit, treatment, history of exacerbation strata, geographical region, BL FEV1 and interaction terms of BL by visit and treatment by visit.|BL to Day 168|ITT Population. Number of par. presented represent those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis.||Liters (L)||Standard Error|Least Squares Mean
840510|NCT01336608|Primary|Mean Change From Baseline (BL) in Aortic Pulse Wave Velocity (aPWV) at the End of the 24-week Treatment Period (Day 168)|PWV is defined as the speed of travel of the pressure pulse along an arterial segment and can be obtained for any arterial segment accessible to palpation. aPWV is measured with tonometers positioned transcutaneously at the base of the common carotid artery and over the femoral artery. PWV increases with arterial stiffness and is defined by the Moens-Korteweg equation: PWV=square root of (Eh/2ρR), where E is Young’s modulus of the arterial wall, h is the wall thickness, R is the arterial radius at the end of diastole, and ρ is the blood density. Change from BL was calculated as the Day 168 value minus the BL value. The analysis was performed using a repeated measures model with covariates of treatment, visit, age, gender, smoking history, history of exacerbation strata, geographical region, BL aPWV and interaction terms of BL by visit and treatment by visit.|BL to Day 168|ITT Population: all randomized par. who received at least one dose of study medication. Number of par. presented represent those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis.||meters per second (m/sec)||Standard Error|Least Squares Mean
840511|NCT01336647|Secondary|Safety and Tolerability of Ha44 Gel|The number of subjects with Treatment emergent AEs (TEAEs) related to the study medication will be reported by treatment group.|From treatment to last visit of the study at 14 days|All subjects who participated||participants with treatment related AEs|||Number
840512|NCT01336647|Primary|Number of Participants Who Are Lice Free at All Follow-up Visits (Day 1, 7 and 14) Through the Day 14 Visit||Follow up visit at days 1, 7 and 14 days|Intent to Treat||participants|||Number
840513|NCT01336712|Secondary|Cumulative Incidence of Chronic Graft-versus-host Disease||2 year|||percentage of patients analyzed|||Number
840514|NCT01336712|Secondary|Relapse Rate||2 year|||percentage of patients analyzed|||Number
840515|NCT01336712|Secondary|Non-relapsed Mortality (NRM) Percentage||2 year|||percentage of patients|||Number
840520|NCT01336738|Secondary|Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Body Weight Loss From Baseline|The treatment of diabetes has been the recommendation to lose weight. As weight loss progresses and is maintained, an improvement of glycemia may be evidenced by a reduction in HbA1c. Participants with >= 1% or >= 2% body weight loss from baseline signifies an improvement of glycemia.|Week 12|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signify those who were evaluable for this measure.||percentage of participants|||Number
840521|NCT01336738|Secondary|Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Body Weight Gain From Baseline|Overweight or obesity increases the risk for developing diabetes. Participants with >= 1% or >= 2% body weight gain from baseline signifies a higher risk of diabetes.|Week 12|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signify those who were evaluable for this measure.||percentage of participants|||Number
840522|NCT01336738|Secondary|Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12|Overweight or obesity increases the risk for developing diabetes. The treatment of diabetes has been the recommendation to lose weight. As weight loss progresses and is maintained, an improvement of glycemia may be evidenced by a reduction in HbA1c.|Baseline, Week 1, 2, 4, 8, 12|FAS included all randomized participants who received at least 1 dose of study medication. Here ‘n’ signifies participants who were evaluable at specific time point for each treatment arm, respectively.||kilogram (kg)||Standard Deviation|Mean
840523|NCT01336738|Secondary|Percentage of Participants Achieving Less Than (<) 6.5% or <7% Glycosylated Hemoglobin (HbA1c) Levels|HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The normal range for the HbA1c test is between 4% and 5.6%. HbA1c levels between 5.7% and 6.4% indicate increased risk of diabetes and levels of 6.5% or higher indicate diabetes.|Week 12|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signify those who were evaluable for this measure.||percentage of participants|||Number
840524|NCT01336738|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 1, 2, 4 and 8|HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The normal range for the HbA1c test is between 4% and 5.6%. HbA1c levels between 5.7% and 6.4% indicate increased risk of diabetes and levels of 6.5% or higher indicate diabetes.|Baseline, Week 1, 2, 4, 8|FAS included all randomized participants who received at least 1 dose of study medication. Here ‘n’ signifies participants who were evaluable at specific time point for each treatment arm, respectively.||percentage of hemoglobin||Standard Deviation|Mean
840525|NCT01336738|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12||Baseline, Week 1, 2, 4, 8, 12|FAS included all randomized participants who received at least 1 dose of study medication. Here ‘n’ signifies participants who were evaluable at specific time point for each treatment arm, respectively.||milligram/deciliter (mg/dL)||Standard Deviation|Mean
840526|NCT01336738|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12|HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The normal range for the HbA1c test is between 4 percent (%) and 5.6%. HbA1c levels between 5.7% and 6.4% indicate increased risk of diabetes and levels of 6.5% or higher indicate diabetes.|Baseline, Week 12|Full analysis set (FAS) included all randomized participants who received at least 1 dose of study medication. Here ‘n’ signifies participants who were evaluable at specific time point for each treatment arm, respectively.||percentage of hemoglobin||Standard Deviation|Mean
840527|NCT01336764|Primary|Reduced Heart Rate During Driving (Aggregated Over Sessions)|averaged over sessions|during 60-90 min driving intervention over the 3 intervention visits which were approximately one week apart|||beats per minute||Standard Deviation|Mean
840528|NCT01336894|Secondary|Pulmonary Function Test Values|Pulmonary function test values include forced expiratory volume 1 (FEV1), carbon monoxide diffusion (DLCO) and forced vital capacity (FVC).|Up to 12 months post-therapy|Study terminated prematurely. Planned analyses was not performed due to the nature of the closure endpoint data is not available.|||||
840529|NCT01336894|Secondary|Disease-free Survival|Disease free survival is defined as the time from randomization until documented disease recurrence or death, whichever occurs first. Patient who are disease free and alive at the time of analysis will be censored at the time of their last follow up.|Up to 5 years post-randomization|Study terminated prematurely. Planned analyses was not performed due to the nature of the closure endpoint data is not available.|||||
840530|NCT01336894|Secondary|Adverse Event Profiles at 12 Months Post-therapy|"Adverse events are described and graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 4.0.
Grading: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death."|12 months post-therapy|Study terminated prematurely. Planned analyses was not performed due to the nature of the closure endpoint data is not available.|||||
840531|NCT01336894|Secondary|Adverse Event Profiles at 3 Months Post-therapy|"Adverse events are described and graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 4.0.
Grading: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death."|3 months post-therapy|All enrolled participants who received protocol interventions and had adverse event reported at months 3 post-therapy.||Participants|||Count of Participants
840532|NCT01336894|Secondary|Adverse Event Profiles at 1 Month Post-therapy|"Adverse events are described and graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 4.0.
Grading: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death."|1 month post-therapy|All enrolled participants who received protocol interventions and had adverse events reported at 1 month post-therapy.||Participants|||Count of Participants
840533|NCT01336894|Secondary|Loco-regional Recurrence-free Survival|Loco-regional recurrence is defined as recurrence within the same lobe or hilum (N1 nodes), or within 2 cm of the staple line or within 2 cm of the PTV after treatment effects such as scarring have subsided.|Up to 5 years post-randomization|Study terminated prematurely. Planned analyses was not performed due to the nature of the closure endpoint data is not available.|||||
840535|NCT01336972|Secondary|Mean Change From Baseline in 2 Hour Urine Volume After 3 Weeks Tolvaptan Treatment and at 3 Weeks Post Treatment.|The volume of urine from each 2-hour urine collection in the renal function tests at Baseline, Final Treatment, and Post Treatment was recorded. Individual voids in a collection interval were pooled before determination of total volume.|2 hours|All participants who took any trial medication and had a postbaseline renal function test.||mL||Standard Deviation|Mean
840536|NCT01336972|Secondary|Mean Change From Baseline in 24 Hour Urine Volume After 3 Weeks Tolvaptan Treatment and at 3 Weeks Post Treatment.|A 24-hour split urine sample (approximate times: 0700 to 1700 hours, 1700 hours to bedtime, and bedtime to 0700 hours) was collected beginning the day before the Baseline, Final Treatment, and Post Treatment visits and ending at admission to the renal function ward. Individual voids in a collection interval were pooled and the total volume determined.|24 hours|All participants who took any trial medication and had a postbaseline renal function test.||mL||Standard Deviation|Mean
840537|NCT01336972|Secondary|Percentage Change From Baseline in Total Kidney Volume (TKV) After 3 Weeks of Tolvaptan Treatment and at 3 Weeks Post Treatment.|TKV was measured using magnetic resonance imaging.|After 3 weeks of treatment and 3 weeks post treatment|All participants who took any trial medication and had a postbaseline renal function test.||Percent||Standard Deviation|Mean
840538|NCT01336972|Secondary|Area Under the Concentration-time Curve From 0 to 5 Hours (AUC0-5) After 3 Weeks of Tolvaptan Treatment.|"Blood sampling for determination of tolvaptan concentrations took place at the Baseline, Final Treatment, and the Post Treatment or Early Termination visits.
At the Final Treatment visit (Day 21 [+/- 1 day)]), blood samples were collected prior to the start of infusion of study treatment and at 1, 2, 3, 4, and 5 hours postdose.
At the Baseline (Day 0), and Post Treatment visit (3 weeks [+/-3 days] after last dose), a blood sample was collected prior to the start of infusion of study treatment."|Day 0: 0 hour, Day 21: (0, 1, 2, 3, 4 and 5 hours postdose), 3 Weeks after last dose: 0 hour|All participants who took any trial medication and had a postbaseline renal function test.||ng.h/mL||Standard Deviation|Mean
840539|NCT01336972|Secondary|Time to Peak Plasma Concentration (Tmax) After 3 Weeks of Tolvaptan Treatment.|"Blood sampling for determination of tolvaptan concentrations took place at the Baseline, Final Treatment, and the Post Treatment or Early Termination visits.
At the Final Treatment visit (Day 21 [+/- 1 day)]), blood samples were collected prior to the start of infusion of study treatment and at 1, 2, 3, 4, and 5 hours postdose.
At the Baseline (Day 0), and Post Treatment visit (3 weeks [+/-3 days] after last dose), a blood sample was collected prior to the start of infusion of study treatment."|Day 0: 0 hour, Day 21: (0, 1, 2, 3, 4 and 5 hours postdose), 3 Weeks after last dose: 0 hour|All participants who took any trial medication and had a postbaseline renal function test.||hours||Full Range|Median
840540|NCT01336972|Secondary|Time to Peak Plasma Concentration (Cmax) After 3 Weeks of Tolvaptan Treatment.|"Blood sampling for determination of tolvaptan concentrations took place at the Baseline, Final Treatment, and the Post Treatment or Early Termination visits.
At the Final Treatment visit (Day 21 [+/- 1 day)]), blood samples were collected prior to the start of infusion of study treatment and at 1, 2, 3, 4, and 5 hours postdose.
At the Baseline (Day 0), and Post Treatment visit (3 weeks [+/-3 days] after last dose), a blood sample was collected prior to the start of infusion of study treatment."|Day 0: 0 hour, Day 21: (0, 1, 2, 3, 4 and 5 hours postdose), 3 Weeks after last dose: 0 hour|All participants who took any trial medication and had a postbaseline renal function test.||ng/mL||Standard Deviation|Mean
840541|NCT01336972|Secondary|Mean Change From Baseline in Free Water Clearance After 3 Weeks of Tolvaptan Treatment and at 3 Weeks Post Treatment|Renal function measurements were performed using the constant infusion method with 125I-iothalamate and 131I-hippuran. A priming solution containing 20 mL infusion solution (0.04 MBq of 125I-iothalamate and 0.03 MBq of 131I-hippuran) was given at 08:00 hours, followed by a constant infusion of 6 to 12 mL/h, with the lowest infusion rates in subjects with impaired renal function, based on previously known serum creatinine concentrations. Plasma concentrations of both tracers were allowed to stabilize during a 1.5-hour equilibration, which was followed by two 2-hour periods (09:30 to 11:30 hours and 11:30 to 13:30 hours) for simultaneous clearances of 125I-iothalamate and 131I-hippuran. Blood was drawn at 1, 2, 3, 4, and 5 hours post consumption of water/tolvaptan (08:30 hours).|After 3 weeks of treatment and 3 weeks post treatment|All participants who took any trial medication and had a postbaseline renal function test.||mL/min||Standard Deviation|Mean
840542|NCT01336972|Primary|Mean Change From Baseline in Filtration Fraction (GFR/ERFP) After 3 Weeks of Tolvaptan Treatment and at 3 Weeks Post Treatment.|Renal function measurements were performed using the constant infusion method with 125I-iothalamate and 131I-hippuran. A priming solution containing 20 mL infusion solution (0.04 MBq of 125I-iothalamate and 0.03 MBq of 131I-hippuran) was given at 08:00 hours, followed by a constant infusion of 6 to 12 mL/h, with the lowest infusion rates in subjects with impaired renal function, based on previously known serum creatinine concentrations. Plasma concentrations of both tracers were allowed to stabilize during a 1.5-hour equilibration, which was followed by two 2-hour periods (09:30 to 11:30 hours and 11:30 to 13:30 hours) for simultaneous clearances of 125I-iothalamate and 131I-hippuran. Blood was drawn at 1, 2, 3, 4, and 5 hours post consumption of water/tolvaptan (08:30 hours).|After 3 weeks of treatment and 3 weeks post treatment|All participants who took any trial medication and had a postbaseline renal function test.||Ratios||Standard Deviation|Mean
840543|NCT01336972|Primary|Mean Change From Baseline in Effective Renal Plasma Flow (ERPF) After 3 Weeks of Tolvaptan Treatment and at 3 Weeks Post Treatment.|Renal function measurements were performed using the constant infusion method with 125I-iothalamate and 131I-hippuran. A priming solution containing 20 mL infusion solution (0.04 MBq of 125I-iothalamate and 0.03 MBq of 131I-hippuran) was given at 08:00 hours, followed by a constant infusion of 6 to 12 mL/h, with the lowest infusion rates in subjects with impaired renal function, based on previously known serum creatinine concentrations. Plasma concentrations of both tracers were allowed to stabilize during a 1.5-hour equilibration, which was followed by two 2-hour periods (09:30 to 11:30 hours and 11:30 to 13:30 hours) for simultaneous clearances of 125I-iothalamate and 131I-hippuran. Blood was drawn at 1, 2, 3, 4, and 5 hours post consumption of water/tolvaptan (08:30 hours).|After 3 weeks of treatment and 3 weeks post treatment|All participants who took any trial medication and had a postbaseline renal function test.||mL/min||Standard Deviation|Mean
840610|NCT01337609|Secondary|Adequate Relief of IBS Pain (AR-IBS)|The AR-IBS is a self-administered measure of the adequacy of the relief of IBS pain.|Adminstered at each of 8 visits (every 10 days), Endpoint is Final Visit|Because the study sponsor chose to discontinue funding for this protocol following a change in leadership, the study was terminated early and this outcome measure was not analyzed.|||||
840544|NCT01336972|Primary|Mean Change From Baseline in Measured Glomerular Filtration Rate (mGFR) After 3 Weeks of Tolvaptan Treatment and at 3 Weeks Post Treatment.|Renal function measurements were performed using the constant infusion method with 125I-iothalamate and 131I-hippuran. A priming solution containing 20 mL infusion solution (0.04 MBq of 125I-iothalamate and 0.03 MBq of 131I-hippuran) was given at 08:00 hours, followed by a constant infusion of 6 to 12 mL/h, with the lowest infusion rates in subjects with impaired renal function, based on previously known serum creatinine concentrations. Plasma concentrations of both tracers were allowed to stabilize during a 1.5-hour equilibration, which was followed by two 2-hour periods (09:30 to 11:30 hours and 11:30 to 13:30 hours) for simultaneous clearances of 125I-iothalamate and 131I-hippuran. Blood was drawn at 1, 2, 3, 4, and 5 hours post consumption of water/tolvaptan (08:30 hours). The mGFR was corrected for voiding errors.|After 3 weeks of treatment and 3 weeks post treatment|All participants who took any trial medication and had a postbaseline renal function test.||mL/min||Standard Deviation|Mean
840545|NCT01337050|Secondary|Progression Free Survival (PFS)|PFS was defined as the time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first. PFS calculated as (Months) = (first event date minus randomization or the first dose date plus 1) divided by 30.44). PFS was calculated using the median, and 95% Confidence Intervals (CIs) and Progressive disease (PD):>=20% (>= 5 mm increase) increase sum of LD of TL taking as a reference smallest sum of LD recorded since treatment start, appearance of >=1 new lesions, unequivocal progression of existing non-TL, or appearance of >=1 new lesion.|Baseline, thereafter every 6 weeks up to end of treatment (up to Cycle 30)|Response evaluable population included all enrolled participants with measurable disease who received at least 1 dose of PF-03446962 and had an adequate baseline tumor assessment. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||months||95% Confidence Interval|Median
840546|NCT01337050|Secondary|Number of Participants With Clinical Benefit Response (CBR)|Number of participant with clinical benefit response (CBR): CBR was defined as CR, PR, SD >12 weeks, SD<12weeks or PD according to RECIST criteria; Complete response (CR): disappearance of all lesions, Pathological lymph nodes’ reduction in short axis (SA) to <10 mm; Partial response (PR): >=30% decrease in sum of longest dimensions (LD) of Target Lesions (TL) taking reference baseline sum LD; Progressive disease (PD):>=20% (>= 5 mm increase) increase sum of LD of TL taking as a reference smallest sum of LD recorded since treatment start, appearance of >=1 new lesions, unequivocal progression of existing non-TL, or appearance of >=1 new lesion; Stable disease (SD): insufficient shrinkage to qualify for PR, insufficient increase to qualify for PD taking reference smallest sum of the LD since treatment start.|Baseline, thereafter every 6 weeks up to end of treatment (up to Cycle 30)|Response evaluable population included all enrolled participants with measurable disease who received at least 1 dose of PF-03446962 and had an adequate baseline tumor assessment. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||participants|||Number
840547|NCT01337050|Secondary|Number of Participants With Best Overall Response (BOR)|Number of participants with best overall response according to Response Evaluation Criteria in Solid Tumors (RECIST); Complete response (CR): disappearance of all lesions, Pathological lymph nodes’ reduction in short axis (SA) to less than (<)10 millimeter (mm); Partial response (PR): greater than equal to (>=) 30% decrease in sum of longest dimensions (LD) of Target Lesions (TL) taking reference baseline sum LD; Progressive disease (PD):>=20% (>= 5 mm increase) increase sum of LD of TL taking as a reference smallest sum of LD recorded since treatment start, appearance of >=1 new lesions, unequivocal progression of existing non-TL, or appearance of >=1 new lesion; Stable disease (SD): insufficient shrinkage to qualify for PR, insufficient increase to qualify for PD taking reference smallest sum of the LD since treatment start. Confirmed response=that persist at least 4 weeks after initial documentation.|Baseline, thereafter every 6 weeks up to end of treatment (up to Cycle 30)|Response evaluable population included all enrolled participants with measurable disease who received at least 1 dose of PF-03446962 and had an adequate baseline tumor assessment. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||participants|||Number
840548|NCT01337050|Secondary|Number of Participants With Human Anti-Human Antibody (HAHA)|HAHA analysis was performed using validated, sensitive and specific chemiluminescence enzyme-linked immunosorbent assay (ELISA) methodology.|Baseline, Post-dose (Day 1 of every Cycle up to 28 days after last dose) up to Cycle 30|Safety analysis set included all enrolled participants who received at least 1 dose of study medication.||participants|||Number
840549|NCT01337050|Secondary|Soluble Proteins Level|Soluble proteins related to Activin Receptor-Like Kinase 1 (ALK-1) signaling and angiogenesis signaling including Vascular adhesion molecule (VAM), Monocyte chemotactic protein 1 (MCP-1), Angiopoietin 2, Tear intercellular adhesive molecule 1 (ICAM-1), Soluble intracellular adhesion molecule 1 (SIAM-1), Soluble vascular adhesion molecule 1 (SVAM-1), Vascular endothelial growth factor A (VEGF-A), Vascular endothelial growth factor C (VEGF-C), Vascular endothelial growth factor D (VEGF-D), Soluble vascular endothelial growth factor- Receptor 1 (REC 1) (SVEGF-REC 1), Soluble vascular endothelial growth factor- REC 2 (SVEGF-REC 2), Soluble vascular endothelial growth factor- REC 3 (SVEGF-REC 3), Bone morphogenetic protein-9 (BMP-9), Endoglin, Transforming growth factor- beta 1 (TGF- Beta 1), Placental growth factor (PGF) was evaluated.|Baseline, Day 1, 0 hour (H), 6 H Cycle 1 Day 1, Day 22 of Cycle 1, Day 1 Cycle 2, Day 1 Cycle 3 and end of treatment (up to cycle 30)|Biomarker analysis population included all enrolled and treated participants with baseline and on-treatment biomarker sample analyzed. Here “n”= participants who were evaluable for specified biomarker at given time point for each arm, respectively.||picogram per milliliter (pg/mL)||Standard Deviation|Mean
840550|NCT01337050|Secondary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre dose), 0.5, 1 (right before the end of infusion), 1.5, 2, 5, 8, 24 hours after the start of infusion of the first dose on Day 1; Day 3, 5, 8, 11, 15, 22 of Cycle 1|PK parameter analysis population included all participants treated who had at least 1 of the PK parameters of interest. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||days||Standard Deviation|Mean
840611|NCT01337609|Secondary|Visual Analog Scale (VAS)|The VAS is a self-administered measure of abdominal pain, discomfort, and bloating. The change in total score from baseline to study endpoint will be assessed.|Administered at each of 8 study visits (every 10 days), Endpoint is Final Visit|Because the study sponsor chose to discontinue funding for this protocol following a change in leadership, the study was terminated early and this outcome measure was not analyzed.|||||
840551|NCT01337050|Secondary|Volume of Distribution (Vd)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.|0 (pre dose), 0.5, 1 (right before the end of infusion), 1.5, 2, 5, 8, 24 hours after the start of infusion of the first dose on Day 1; Day 3, 5, 8, 11, 15, 22 of Cycle 1|PK parameter analysis population included all participants treated who had at least 1 of the PK parameters of interest. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||liter (L)||Geometric Coefficient of Variation|Geometric Mean
840552|NCT01337050|Secondary|Systemic Clearance (CL)|CL is a quantitative measure of the rate at which a drug substance is removed from the body.|0 (pre dose), 0.5, 1 (right before the end of infusion), 1.5, 2, 5, 8, 24 hours after the start of infusion of the first dose on Day 1; Day 3, 5, 8, 11, 15, 22 of Cycle 1|PK parameter analysis population included all participants treated who had at least 1 of the PK parameters of interest. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||liter per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
840553|NCT01337050|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) for drug.|0 (pre dose), 0.5, 1 (right before the end of infusion), 1.5, 2, 5, 8, 24 hours after the start of infusion of the first dose on Day 1; Day 3, 5, 8, 11, 15, 22 of Cycle 1|PK parameter analysis population included all participants treated who had at least 1 of the PK parameters of interest.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
840554|NCT01337050|Secondary|Area Under the Curve From Time Zero to 28 Days [AUC (0-28)]|AUC (0-28)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-28).|0 (pre dose), 0.5, 1 (right before the end of infusion), 1.5, 2, 5, 8, 24 hours after the start of infusion of the first dose on Day 1; Day 3, 5, 8, 11, 15, 22 of Cycle 1|PK parameter analysis population included all participants treated who had at least 1 of the PK parameters of interest. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||nanogram*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
840555|NCT01337050|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 (pre dose), 0.5, 1 (right before the end of infusion), 1.5, 2, 5, 8, 24 hours after the start of infusion of the first dose on Day 1; Day 3, 5, 8, 11, 15, 22 of Cycle 1|PK parameter analysis population included all participants treated who had at least 1 of the PK parameters of interest.||hours (hr)||Full Range|Median
840556|NCT01337050|Secondary|Minimum Observed Serum Trough Concentration (Cmin)||0 (pre dose), 0.5, 1 (right before the end of infusion), 1.5, 2, 5, 8, 24 hours after the start of infusion of the first dose on Day 1; Day 3, 5, 8, 11, 15, 22 of Cycle 1|PK parameter analysis population included all participants treated who had at least 1 of the PK parameters of interest. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
840557|NCT01337050|Secondary|Maximum Observed Serum Concentration (Cmax)||0 (pre dose), 0.5, 1 (right before the end of infusion), 1.5, 2, 5, 8, 24 hours after the start of infusion of the first dose on Day 1; Day 3, 5, 8, 11, 15, 22 of Cycle 1|Pharmacokinetic (PK) parameter analysis population included all participants treated who had at least 1 of the PK parameters of interest.||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
840558|NCT01337050|Secondary|Number of Participants With Laboratory Abnormalities|Laboratory abnormalities were segregated into hematology, chemistry, coagulation and urinalysis test. It had been graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) into Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Life-threatening). Participants with abnormality of any of these grades are reported.|Baseline up to 28 days after last dose|Safety analysis set included all participants who received at least 1 dose of study medication.||participants|||Number
840559|NCT01337050|Secondary|Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious adverse events (non-SAEs). Relatedness to study drug was assessed based on investigator's discretion.|Baseline up to 28 days after last dose|Safety analysis set included all enrolled participants who received at least 1 dose of study medication.||participants|||Number
840560|NCT01337050|Secondary|Number of Participants With Treatment Emergent Adverse Events (AEs) Based on Severity|Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed according to severity; Grade 1 (Mild Adverse Event), Grade 2 (Moderate Adverse Event), Grade 3 (Severe Adverse Event), Grade 4 (Life- Threatening or Disabling Adverse Event), Grade 5 (Death Related to Adverse Event).|Baseline up to 28 days after last dose|Safety analysis set included all enrolled participants who received at least 1 dose of study medication.||participants|||Number
840561|NCT01337050|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-serious adverse events (non-SAEs).|Baseline up to 28 days after last dose|Safety analysis set included all enrolled participants who received at least 1 dose of study medication.||participants|||Number
840562|NCT01337050|Primary|Recommended Phase-2 Dose (RP2D)|RP2D was determined by a comprehensive assessments based on all the safety data, efficacy data, pharmacokinetics profile and biomarker data using blood and tumor samples.|Baseline up to 28 days after last dose of study medication|Safety analysis set included all enrolled participants who received at least 1 dose of study medication.||mg/kg|||Number
840563|NCT01337050|Primary|Maximum Tolerated Dose (MTD)|The MTD was defined as the highest dose of PF-03446962 associated with the occurrence of Dose Limiting Toxicities (DLTs) in at most 1 of 6 participants with the next higher dose having at least 2/3 or 2/6 participants experiencing DLTs (that is (i.e.) Maximum Administrated Dose). DLT is defined if the participants meets the following criteria during the first 6 weeks of treatment, possibly attributable to PF-03446962. Neutropenia grade 4 (less than [< ])500/cubic millimeter [mm^ 3]) lasting for greater than equal to (>=) 8 days; Febrile Neutropenia >= Grade 3; Neutropenic Infection >= Grade 3; Grade 4 thrombocytopenia (<25,000/mm^3); Grade 3 thrombocytopenia (<50,000/mm^3) with active bleeding; Grade 3 or higher non-hematological toxicity.|Baseline up to Week 6|Safety analysis set included all enrolled participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||mg/kg|||Number
840564|NCT01337076|Primary|CNC Monosyllabic Word Score - Treated Ear|"The primary study endpoint was to test whether a statistically significant difference could be obtained between the mean, preoperative Consonant Nucleus Consonant (CNC) monosyllabic word score in the ear to be implanted compared to the postoperative CNC word score in the cochlear implant alone condition at 6 months postimplant activation for candidates who currently perform outside the approved Nucleus® cochlear implant candidacy requirements.
CNC Word Test is a validated test of open-set word recognition. The test consists of 10 lists with 50 monosyllabic words in each list. Subject responses are scored for both words and phonemes correct in the correct sequence. Subjects will be tested using a configuration of speech at 0º azimuth in quiet."|Six months|||percent correct||Full Range|Mean
840565|NCT01337115|Primary|VAS Results - Pain Scores Measured in mm (0-100)|"VAS pain scores are measured by blinded investigators 24h after surgery .
VAS scale:
0 - no pain 100 - worst possible pain"|24h after surgery|In the CFNB group 2 patients did not complete the protocol. Analysis was made in an ITT manner and Last Observational Carried Forward (LOCF) was the imputation technique used. In the SNB group, all 25 patients completed the protocol||units on a scale||Standard Deviation|Mean
840566|NCT01337115|Primary|VAS Results - Pain Measured in mm (0-100)|"VAS pain scores are measured by blinded investigators 12h after surgery .
VAS scale:
0 - no pain 100 - worst possible pain"|12h after surgery|All 25 patients in each arm completed the protocol. Analysis was made in an ITT manner.||units on a scale||Standard Deviation|Mean
840567|NCT01337115|Secondary|Satisfaction With Anesthesia Technique in Each Arm of the Study|"Satisfaction with the anesthesia technique using a categorical scale with three levels:
Bad Reasonable Good/Very Good A Fisher's Exact test is made to asses any differences in the distribution of patients in each arm to each level of the categorical scale"|1 month after surgery|Analysis was performed on Participants available for telephone contact one month after surgery and was made per protocol.||participants|||Number
840568|NCT01337115|Primary|Visual Analogue Scores (VAS) - Pain Scores Measured in mm (0-100)|Pain scores measured by Visual Analogue Score (VAS) scale at 15-30min after Post anesthesia care unit (PACU) arrival VAS is a 100mm scale to measure pain. 0mm - no pain 100mm - worst possible pain|15-30 min after arrival on post anesthesia care unit (PACU)|Participants were analyzed in an Intention to treat (ITT) manner. All randomized subjects (25 in each arm) completed the protocol so all were included for analysis as planned.||units on a scale||Standard Deviation|Mean
840569|NCT01337167|Secondary|Percentage of Participants With Pyrexia, Febrile Convulsion, or Convulsion|The percentage of participants with one or more adverse events (AE), serious adverse events (SAE), and vaccine-related SAE (pyrexia, febrile convulsion, and convulsion) is reported.|Up to 181 days after any infant vaccination (up to 12 months)|Participants included in this analyses were All Subjects as Treated population and were defined as all vaccinated participants with safety follow up.||Percentage of participants|||Number
840570|NCT01337167|Secondary|Percentage of Participants With Pyrexia, Febrile Convulsion, or Convulsion|The percentage of participants with one or more adverse events (AE), serious adverse events (SAE), and vaccine-related SAE (pyrexia, febrile convulsion, and convulsion) is reported.|Up to 15 days after any infant vaccination (up to 6 months)|Participants included in this analyses were All Subjects as Treated population and were defined as all vaccinated participants with safety follow up.||Percentage of participants|||Number
840571|NCT01337167|Secondary|Percentage of Participants With Elevated Temperature by Severity|Maximum temperature (all routes) was based on actual temperatures recorded with no adjustments to the measurement route. Maximum temperature (rectal) was required of all participants if the reading by another method was >=38.0°C.|Up to 5 days after any infant vaccination (up to 6 months)|Participants included in this analyses were All Subjects as Treated population and were defined as all vaccinated participants with safety follow up and temperature data.||Percentage of participants|||Number
840572|NCT01337167|Secondary|Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug|Solicited systemic adverse events: pyrexia, vomiting, crying abnormal, somnolence, decreased appetite, and irritability. Adverse events deemed related to study drug were those judged to be definitely related, probably related, or possibly related by the investigator.|Up to 5 days after each infant vaccination (up to 6 months)|Participants included in this analyses were All Subjects as Treated population and were defined as all vaccinated participants with safety follow up.||Percentage of participants|||Number
840573|NCT01337167|Secondary|Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug|Solicited systemic adverse events: pyrexia, vomiting, crying abnormal, somnolence, decreased appetite, and irritability. Adverse events deemed related to study drug were those judged to be definitely related, probably related, or possibly related by the investigator.|Up to 5 days after any infant vaccination (up to 6 months)|Participants included in this analyses were All Subjects as Treated population and were defined as all vaccinated participants with safety follow up.||Percentage of participants|||Number
840585|NCT01337167|Primary|Geometric Mean Concentration of Antibodies to Pertussis Fimbriae|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||EU/mL||95% Confidence Interval|Geometric Mean
840684|NCT01332188|Secondary|Tearing at Duration of Action (24 Hours Post-dose)|A treatment efficacy CAC was performed 24 hours after drop instillation. Tearing was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of tearing score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)||units on a scale||Standard Deviation|Mean
840574|NCT01337167|Secondary|Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions|Solicited injection-site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Pyrexia, Vomiting, Crying abnormal, Somnolence, Decreased appetite, and Irritability. Grade 3 Solicited injection site reaction: Pain, Cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, >5 cm. Grade 3 Solicited systemic reactions: Pyrexia, >=39.5°C (>=103.1°F) rectal; Vomiting, >=6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, >3 hours; Somnolence, Sleeping most of the time or difficult to wake up; Decreased appetite, Refuses >=3 feeds or refuses most feeds; Irritability, Inconsolable.|Up to 5 days after any infant vaccination (up to 6 months)|Participants included in these analyses were All Subjects as Treated population and were defined as all vaccinated participants with safety follow up.||Percentage of participants|||Number
840575|NCT01337167|Secondary|Geometric Mean Concentration of Immunoglobulin A (IgA) Antibodies to Rotavirus|Participant serum samples were collected for testing with an Enzyme-linked Immunosorbent assay for IgA antibodies to rotavirus.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||units/mL||95% Confidence Interval|Geometric Mean
840576|NCT01337167|Secondary|Geometric Mean Concentration of Antibodies to Polyribosylribitol Phosphate Antigen|Participant serum samples were collected for testing with a radioimmunoassay for antibodies to Haemophilus influenza type b capsular polysaccharide polyribosylribitol phosphate.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||μg/mL||95% Confidence Interval|Geometric Mean
840577|NCT01337167|Primary|Geometric Mean Concentration of Antibodies to Pertussis Fimbriae|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae.|Postdose 4 (Month 16)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.||EU/mL||95% Confidence Interval|Geometric Mean
840578|NCT01337167|Primary|Geometric Mean Concentration of Antibodies to Pertussis Pertactin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin.|Postdose 4 (Month 16)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.||EU/mL||95% Confidence Interval|Geometric Mean
840579|NCT01337167|Primary|Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin.|Postdose 4 (Month 16)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.||EU/mL||95% Confidence Interval|Geometric Mean
840580|NCT01337167|Primary|Geometric Mean Concentration of Antibodies to Pertussis Toxin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin.|Postdose 4 (Month 16)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.||EU/mL||95% Confidence Interval|Geometric Mean
840581|NCT01337167|Primary|Percentage of Participants Responding to Pertussis Fimbriae|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae. Response was defined as follows: 1) if the predose titer was <4 times the lower limit of quantitation (4X LLOQ) then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer.|Postdose 4 (Month 16)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.||Percentage of participants||95% Confidence Interval|Number
840582|NCT01337167|Primary|Percentage of Participants Responding to Pertussis Pertactin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin. Response was defined as follows: 1) if the predose titer was <4 times the lower limit of quantitation (4X LLOQ) then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer.|Postdose 4 (Month 16)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.||Percentage of participants||95% Confidence Interval|Number
840583|NCT01337167|Primary|Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin. Response was defined as follows: 1) if the predose titer was <4 times the lower limit of quantitation (4X LLOQ) then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer.|Postdose 4 (Month 16)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.||Percentage of participants||95% Confidence Interval|Number
840584|NCT01337167|Primary|Percentage of Participants Responding to Pertussis Toxin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin. Response was defined as follows: 1) if the predose titer was <4 times the lower limit of quantitation (4X LLOQ) then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer.|Postdose 4 (Month 16)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.||Percentage of participants||95% Confidence Interval|Number
840586|NCT01337167|Primary|Geometric Mean Concentration of Antibodies to Pertussis Pertactin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||EU/mL||95% Confidence Interval|Geometric Mean
840587|NCT01337167|Primary|Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||EU/mL||95% Confidence Interval|Geometric Mean
840588|NCT01337167|Primary|Geometric Mean Concentration of Antibodies to Pertussis Toxin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin. The unit of measure is ELISA units/mL (EU/mL).|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||EU/mL||95% Confidence Interval|Geometric Mean
840589|NCT01337167|Primary|Percentage of Participants Responding to Poliovirus Type 3|Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 3. Response is defined as a titer >=8.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||Percentage of participants||95% Confidence Interval|Number
840590|NCT01337167|Primary|Percentage of Participants Responding to Poliovirus Type 2|Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 2. Response is defined as a titer >=8.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||Percentage of participants||95% Confidence Interval|Number
840591|NCT01337167|Primary|Percentage of Participants Responding to Poliovirus Type 1|Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 1. Response is defined as a titer >=8.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||Percentage of participants||95% Confidence Interval|Number
840592|NCT01337167|Primary|Percentage of Participants Responding to Pertussis Fimbriae|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae. Response was defined as follows: 1) if the predose titer was <4X LLOQ then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||Percentage of participants||95% Confidence Interval|Number
840593|NCT01337167|Primary|Percentage of Participants Responding to Pertussis Pertactin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin. Response was defined as follows: 1) if the predose titer was <4X LLOQ then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||Percentage of participants||95% Confidence Interval|Number
840594|NCT01337167|Primary|Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin. Response was defined as follows: 1) if the predose titer was <4X LLOQ then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||Percentage of participants||95% Confidence Interval|Number
840595|NCT01337167|Primary|Percentage of Participants Responding to Pertussis Toxin|Participant serum samples were collected for testing with an Enzyme-linked Immunosorbent Assay (ELISA) for antibodies to pertussis toxin. Response was defined as follows: 1) if the predose titer was <4 times the lower limit of quantitation (4X LLOQ) then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||Percentage of participants||95% Confidence Interval|Number
840596|NCT01337167|Primary|Percentage of Participants Responding to Tetanus Toxin|Participant serum samples were collected for testing with an ELISA for anti-tetanus antibodies. Response was defined as a titer >=0.1 IU/mL.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||Percentage of participants||95% Confidence Interval|Number
840597|NCT01337167|Primary|Percentage of Participants Responding to Diphtheria Toxin|Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to diphtheria toxin. Response was defined as a titer >=0.1 International unit (IU)/mL.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||Percentage of participants||95% Confidence Interval|Number
840598|NCT01337167|Primary|Percentage of Participants Responding to Hepatitis B Surface Antigen|Participant serum samples were collected for testing with an enhanced chemiluminescence assay for antibodies to Hepatitis B Surface Antigen. Response was defined as a titer >=10 milli International units (mIU)/mL.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||Percentage of participants||95% Confidence Interval|Number
840599|NCT01337167|Primary|Percentage of Participants Responding to Polyribosylribitol Phosphate Antigen|Participant serum samples were collected for testing with a radioimmunoassay for antibodies to Haemophilus influenza type b capsular polysaccharide polyribosylribitol phosphate. Response was evaluated for titer >=0.15 μg/mL and >=1.0 μg/mL.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||Percentage of participants||95% Confidence Interval|Number
840600|NCT01337297|Secondary|State of Depression|It will be applied Hamilton Scale for Depression, a structured multiple choice questionnaire used to assess the severity of the symptoms of depression. It will be applied with cognitive tests.|Before the first experimental session, in the middle of the treatment and after the last experimental session.||||||
840601|NCT01337297|Secondary|Cognitive Tests|Cognitive tests are comprised by frontal assessment battery (FAB), Mini-Mental Status Examination (MMSE), verbal n-back task, visuospatial n-back task, go/no-go test.|Before the first experimental session, in the middle of the protocol and two days after the last experimental session||||||
840602|NCT01337297|Secondary|Event Related Potentials|Event Related Potentials (ERPs) elicited by random presentation of three related images and three non-related images to crack use every Monday and Friday over the two-weeks period of active-tDCS or sham-tDCS.|twice a week over two consecutive weeks during the treatment||||||
840603|NCT01337297|Secondary|Intensity of the Urge to the Use of Crack-cocaine|The intensity of craving will be examined by a short scale, the Brief Cocaine Craving Questionnaire.|before and after ERP in two weekly sessions over two weeks||||||
840604|NCT01337297|Primary|Abstinence|abstinence to the use of crack-cocaine up to 3 months after the completion of two-weeks of treatment sessions with active-tDCS or sham-tDCS.|Two days after the end of tDCS treatment (one session every other day, 5 sessions), that is, on the 12nd day from the beginning.|||percentage of participants|||Number
840605|NCT01337336|Secondary|Number of the Indicated COPD-related Exacerbations|The number of COPD-related exacerbations was identified during the follow-up period. Five types of COPD-related exacerbations were defined: -COPD-related hospitalization, ER visit, physician visit with a prescription (Rx) for oral corticosteroid or antibiotic within 5 days of the visit, combined occurrence of COPD-related hospitalization/ER visit, or combined occurrence of any COPD-related exacerbation. The index date is defined as the date of first chronologically occurring COPD maintenance medication of interest during an identification period spanning January 1, 2004 to June 30, 2008.|Maximum of 1 year after index date (January 1, 2004 through June 30, 2009)|Managed care enrollees (aged >=40 years) diagnosed with COPD (ICD code 491.xx, 492.xx, and 496.xx) and depression/anxiety before or within 60 days of the date of first prescription for a maintenance medication for COPD (index date).||number of exacerbations||Standard Deviation|Mean
840606|NCT01337336|Secondary|Mean Annual COPD-related Costs Per Participant|Cost categories included medical, pharmacy, and total (calculated as the sum of medical and pharmacy). COPD-related medical costs were computed using claims with a primary diagnosis of COPD, and COPD-related pharmacy costs were computed using the paid amounts of pharmacy claims for prescription medication used for COPD.The index date is defined as the date of first chronologically occurring COPD maintenance medication of interest during an identification period spanning January 1, 2004 to June 30, 2008.|Maximum of 1 year after index date (January 1, 2004 through June 30, 2009)|Managed care enrollees (aged >=40 years) diagnosed with COPD (ICD code 491.xx, 492.xx, and 496.xx) and depression/anxiety before or within 60 days of the date of first prescription for a maintenance medication for COPD (index date).||United States (US) dollars||Standard Deviation|Mean
840607|NCT01337336|Secondary|Number of Participants With the Indicated COPD-related Exacerbations|The number of participants with a COPD-related exacerbation was identified during the follow-up period. Four types of COPD-related exacerbations were defined: COPD-related hospitalization, ER visit, physician visit with a prescription (Rx) for oral corticosteroid or antibiotic within 5 days of the visit, or combined occurrence of COPD-related hospitalization/ER visit. The index date is defined as the date of first chronologically occurring COPD maintenance medication of interest during an identification period spanning January 1, 2004 to June 30, 2008.|Maximum of 1 year after index date (January 1, 2004 through June 30, 2009)|Managed care enrollees (aged >=40 years) diagnosed with COPD (ICD code 491.xx, 492.xx, and 496.xx) and depression/anxiety before or within 60 days of the date of first prescription for a maintanance medication for COPD (index date).||participants|||Number
840608|NCT01337336|Primary|Number of Participants With Any Chronic Obstructive Pulmonary Disease (COPD)-Related Exacerbation|The number of participants with any of the following COPD-related exacerbations during the follow-up period was computed: COPD-related hospitalization, emergency room (ER) visit, or physician visit with a prescription (Rx) for oral corticosteroid (OCS) or antibiotic within 5 days of the visit. The index date is defined as the date of first chronologically occurring COPD maintenance medication of interest during an identification period spanning January 1, 2004 to June 30, 2008.|Maximum of 1 year after index date (January 1, 2004 to June 30, 2009)|Managed care enrollees (aged >=40 years) diagnosed with COPD (ICD code 491.xx, 492.xx, and 496.xx) and depression/anxiety before or within 60 days of the date of first prescription for a maintenance medication for COPD (index date).||participants|||Number
840609|NCT01337609|Secondary|Patient Global Impression of Change (PGI-C) - IBS Symptoms|The PGI-C is a self-administered measure of the degree of improvement in IBS symptoms compared to the first study visit. Degree of improvement in IBS symptoms from first to final visit will be assessed using this scale.|Administered at each of 8 visits (every 10 days), Endpoint is Final Visit|Because the study sponsor chose to discontinue funding for this protocol following a change in leadership, the study was terminated early and this outcome measure was not analyzed.|||||
840612|NCT01337609|Secondary|IBS Severity Scoring System (IBS-SSS)|The IBS-SSS is a validated instrument used to assess common IBS symptoms over the past 10 days including abdominal pain, distention, bowel habit, and global function. The IBS-SSS will be used to assess the absolute change in specific IBS symptoms at endpoint, namely the bloating/distension score.|Adminsitered at each of 8 study visits (every 10 days), Endpoint is Final Visit|Because the study sponsor chose to discontinue funding for this protocol following a change in leadership, the study was terminated early and this outcome measure was not analyzed.|||||
840613|NCT01337609|Primary|Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)|The Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)is a self report measure that addresses depressive symptoms. MDD responders will be defined as those exhibiting a 50% decrease in the QIDS SR at study endpoint.|Administered at each of 8 study visits (every 10 days), Endpoint is Final Visit|Because the study sponsor chose to discontinue funding for this protocol following a change in leadership, the study was terminated early and this outcome measure was not analyzed.|||||
840614|NCT01337635|Secondary|Time to Restart Topical Steroids|The time to restart topical steroids and the SCORAD score at time of restart will be secondary study endpoints.|2 years||||||
840615|NCT01337635|Primary|Atopic Dermatitis Severity at the Completion of Treatment|The SCORAD (Severity Scoring of Atopic Dermatitis) is a clinical measurement tool assessing the severity of atopic dermatitis. The range of SCORAD measurements is 0 (best possible outcome) - 103 (worst possible outcome). The primary study endpoint will be the SCORAD score at the end of the 6 week treatment period.|6 weeks|||units on a scale||Full Range|Mean
840616|NCT01337674|Secondary|Steady-state Area Under the Plasma Concentration Versus Time Curve (AUC0-24hr) for MK-4618|Blood samples were collected on Day 7 predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours postdose for the determination of plasma MK-4618 concentration. The hypothesis for this outcome is that the steady-state AUC0-24hr for MK-4618 is >=0.47 uM*hr.|Predose and up to 24 hours postdose on Day 7|The Per Protocol population included participants who complied with the protocol sufficiently to ensure that the data will likely exhibit the effects of treatment, according to the underlying scientific model.||uM*hr||90% Confidence Interval|Geometric Mean
840617|NCT01337674|Primary|Maximum Change From Baseline in Semi-recumbent and Standing Systolic Blood Pressure: Panel B|Semi-recumbent and standing systolic blood pressure was measured predose and at intervals up to 24 hours postdose on Day 1 and Day 7. The baseline value is the average of measurements taken in the hour before dosing. Participants were to rest quietly in a semi-recumbent position for at least 10 minutes before each semi-recumbent measurement.|Baseline (predose) and up to 24 hours postdose on Day 1 and Day 7|The All Subjects as Treated population included all participants who received >=1 dose of study drug.||mmHg||95% Confidence Interval|Mean
840618|NCT01337674|Primary|Maximum Change From Baseline in Semi-recumbent and Standing Systolic Blood Pressure: Panel A|Semi-recumbent and standing systolic blood pressure was measured predose and at intervals up to 24 hours postdose on Day 1 and Day 7. The baseline value is the average of measurements taken in the hour before dosing. Participants were to rest quietly in a semi-recumbent position for at least 10 minutes before each semi-recumbent measurement.|Baseline (predose) and up to 24 hours postdose on Day 1 and Day 7|The All Subjects as Treated population included all participants who received >=1 dose of study drug.||mmHg||95% Confidence Interval|Mean
840619|NCT01337674|Primary|Percentage of Participants With a Clinical or Laboratory Adverse Experience|An adverse experience was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor’s product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor’s product is also an adverse experience. The percentage of participants with a clinical or laboratory adverse experience was recorded.|Up to 42 days|The All Subjects as Treated population included all participants who received >=1 dose of study drug||Percentage of participants|||Number
840620|NCT01337739|Secondary|Time to Discharge|Time to discharge from the Post Anesthesia Care Unit or home or to hospital room.|24 Hours|||minutes||Standard Deviation|Mean
840621|NCT01337739|Primary|The Primary Outcome Will be the Difference in Intraoperative Opioid (Fentanyl) Administration Between Patients Receiving Dexmedetomidine and Those Receiving Propofol.|The primary outcome will be the difference in intraoperative opioid (fentanyl) administration between patients receiving dexmedetomidine and those receiving propofol. As described by mean and standard deviation.|Interoperative period|||Total Morphine Equivalents mg||Standard Deviation|Mean
840622|NCT01337960|Secondary|Anticipatory Postural Adjustments|During gait initiation two force plates measure ground reaction forces and impulses for the postural shifts made in preparation to begin walking.|Baseline, Post-test training at 6 weeks; Retention at 12 weeks (note TMO control has no retention period)|These data were not collected due to technical issues.|||||
840623|NCT01337960|Secondary|Dynamic Gait Index|The Dynamic Gait Index (DGI) assesses individual’s ability to modify balance while walking in the presence of external demands. Performed with a marked distance of 20 feet . The DGI can be performed with or without an assistive device. Scores are based on a 4-point scale: 3 = No gait dysfunction; 2 = Minimal impairment; 1 = Moderate impairment; 0 = Severe impairment. The highest possible score is 24 points. asks include: Steady state walking; Walking with changing speeds; Walking with head turns both horizontally and vertically; Walking while stepping over and around obstacles; Pivoting while walking; Stair climbing.|Baseline, Post-test training at 6 weeks; Retention at 12 weeks (note TMO control has no retention period)|Nonparametric Fisher's exact test was applied to compare between group changes at retention.||units on a scale||Standard Error|Mean
840624|NCT01337960|Secondary|Berg Balance Scale|14-item scale to assess balance function and fall risk, 56 is top score possible (0-56); higher scores indicate higher balance function. Items assess static and dynamic activities of varying difficulty; they are performed to evaluate global level of balance function. Item-level scores range from 0-4, determined by ability to perform the assessed activity; item scores are summed to create the overall score. Subscales are not analyzed.|Baseline, Post-test training at 6 weeks; Retention at 12 weeks (note TMO control has no retention period)|Nonparametric Fisher's exact test was applied to compare between group changes at retention.||units on a scale||Standard Error|Mean
840685|NCT01332188|Secondary|Tearing at Duration of Action (16 Hours Post-dose)|A treatment efficacy CAC was performed 16 hours after drop instillation. Tearing was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of tearing score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)||units on a scale||Standard Deviation|Mean
840625|NCT01337960|Secondary|Gait Kinetics|Anterior-posterior and medio-lateral ground reaction forces during walking to assess propulsive impulses from paretic and nonparetic sides.|Baseline, Post-test training at 6 weeks; Retention at 12 weeks (note TMO control has no retention period)|Nonparametric Fisher's exact test was applied to compare between group changes at retention.||Newton-seconds||Standard Error|Mean
840626|NCT01337960|Primary|Self-selected Floor Walking Velocity Change From Baseline to Post-training and Retention|Velocity and associated spatio-temporal gait parameters from self-selected most comfortable and fastest floor walking over 10m.|Baseline, Post-test training at 6 weeks; Retention at 12 weeks (note TMO control has no retention period)|Nonparametric Fisher's exact test was applied to compare between group changes at retention.||cm/sec||Standard Error|Mean
840627|NCT01338012|Primary|Number of Study Participants Enrolled and Treated Prior to Study Termination|Number of study participants that were enrolled and treated in this trial following completion of study P-11 and prior to study termination.|Study duration: date of first subject registration Dec 2011 and date of last subject visit April 2015|This study was terminated early due to administrative reasons. Only eight subjects out of the ninety subjects planned were enrolled and treated. Given the small number of patients enrolled, results should be interpreted with caution.||Participants|||Count of Participants
840628|NCT01338025|Secondary|Number of Participants Non-adherent as Measured by 3-day Recall|Number of participants reporting a missed medication dose in the past 3 days.|28 Weeks|All eligible participants with adherence data available at week 28.||participants|||Number
840629|NCT01338025|Secondary|Change in HIV-1 RNA Levels|Change in HIV-1 RNA levels from Entry to Week 28|28 Weeks|All eligible participants with HIV-1 RNA results available at entry and at week 28.||copies/mL||Inter-Quartile Range|Median
840630|NCT01338025|Secondary|Change in CD4+ T Cell Count|Change in CD4+ T cell count from entry to Week 28 (CD4+ at entry - CD4+ at Week 28).|Entry to week 28|All eligible participants with CD4+ cell count results available at entry and at week 28.||CD4+ T cell count/mL||Inter-Quartile Range|Median
840631|NCT01338025|Primary|Number of Participants With Immunologic Deterioration|"Immunologic deterioration was declared for a participant if any one of the following conditions is observed within the first 28 weeks:
greater than or equal to 30% decline in absolute CD4+ T cell count from entry, or
development of CDC class C events.
Results report number of participants with immunologic deterioration at week 28 calculated."|From entry to week 28|All eligible participants who entered the study were included in analyses. One participant on Arm A did not meet entry eligibility criteria; was taken off study after the entry visit, and is therefore excluded from all analyses.||participants|||Number
840632|NCT01338493|Secondary|Relief of Back Pain at 6 Months Versus Baseline Using the Back Pain Intensity Score Assessed on a 10 cm Visual Analogue Scale (VAS)|"Back Pain was documented in a Visual Analogue Scale where the patients marked the location on the 10-centimeter line corresponding to the amount of pain they experienced.
0 = no pain, 10 = worst possible pain"|6 months|Reduction of disability was calculated for patients having available data at both baseline and 6 months.||units on a scale||95% Confidence Interval|Mean
840633|NCT01338493|Primary|Reduction of Disability at 6 Months Versus Baseline Using the Oswestry Disability Index (ODI)|The Oswestry Disability Index (ODI) derives from the Oswestry Low Back Pain Questionnaire, it is used to measure disability for low back pain. The index is scored from 0 to 100; 0 meaning 'no disability' and 100 meaning 'maximum disability'.|6 months|Reduction of disability was calculated for patients having available data at both baseline and 6 months.||units on a scale||95% Confidence Interval|Mean
840634|NCT01332071|Primary|Cmax of Metformin Hydrochloride|Cmax is defined as the maximum or “peak” concentration of a drug observed after its administration. Cmax is one of the parameters of particular use in estimating the bioavailability of drugs, by measuring the total amount of drug absorbed.|Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)|Participants who completed the study||ng/ml||Standard Deviation|Mean
840635|NCT01332071|Primary|AUC0-infinity of Metformin Hydrochloride|The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC0-infinity is calculated from time 0 (prior to administration of medication) to infinity (the time of complete elimination of the drug). The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption.|Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)|Participants who completed the study||ng.h/ml||Standard Deviation|Mean
840636|NCT01332071|Primary|AUC0-t of Metformin Hydrochloride|The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC0-t is calculated from time 0 (prior to administration of medication) to time t (the time of the last quantifiable concentration). The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. ng, nanograms; ml, milliliter.|Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)|Participants who completed the study||ng.h/ml||Standard Deviation|Mean
840637|NCT01332071|Primary|AUC0-infinity of Rosiglitazone Maleate|The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC0-infinity is calculated from time 0 (prior to administration of medication) to infinity (the time of complete elimination of the drug). The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption.|Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)|Participants who completed the study||ng.h/ml||Standard Deviation|Mean
840638|NCT01332071|Primary|Cmax of Rosiglitazone Maleate|Cmax is defined as the maximum or “peak” concentration of a drug observed after its administration. Cmax is one of the parameters of particular use in estimating the bioavailability of drugs, by measuring the total amount of drug absorbed.|Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)|Participants who completed the study||ng/ml||Standard Deviation|Mean
840639|NCT01332071|Primary|AUC0-t of Rosiglitazone Maleate|The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC 0-t is calculated from time 0 (prior to administration of medication) to time t (the time of the last quantifiable concentration). The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. ng, nanograms; ml, milliliter.|Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)|Participants who completed the study||ng per hour per ml (ng.h/ml)||Standard Deviation|Mean
840640|NCT01332123|Secondary|Heart Rate Change|Subjects were wearing a wireless heart rate monitor. The respective readings were noted and assessed during and immediately following the trials to estimate individual exertion rates. Changes in heart rate between resting and exertion across the sample were investigated to be able to interpret the primary outcome measures and to discuss limitations of the protocol. Unequal exertion rates within the sample would cause uneven trends biomechanical changes that are related to exertion.|1 hour|||beats/minute||Full Range|Mean
840641|NCT01332123|Primary|Overall Asymmetry Index|"Gait data was continuously recorded and was post processed to determine symmetry between left and right legs. Symmetry was computed by dividing the difference between legs by the average of both legs. 0 marks perfect symmetry and greater values higher asymmetry. There is no maximum limit.
The overall asymmetry index was calculated as the mean of the following: max knee flex, dorsi flexion, plantar flexion (1st and 2nd peak), knee moment, dorsi-flexion moment, plantar-flexion moment, times of max in % of the gait cycle, Stance phase % of gait cycle and step length.
The kinematics asymmetry index was calculated as the mean of the following: maximal knee flex, dorsi flexion, plantar flexion (1st and 2nd peak), the times of max in % of the gait cycle, Stance phase % of gait cycle and step length.
The kinetics asymmetry index was calculated as the mean of the following variables: knee moment, dorsi-flexion moment, plantar-flexion moment, the times of max in % of the gait cycle."|1 hour|Two of the recruited participants were not included in the analysis, as they had bilateral amputations. Bilateral amputation was not posted as an exclusion criteria initially, but posted unanticipated limitations during data collection and analysis.||unit-less index (0 = perfect symmetry)||Standard Deviation|Mean
840642|NCT01332149|Secondary|Change From Baseline in HADS Depression Total Score at Endpoint|The HADS was a self-administered questionnaire that consisted of 2 subscales, 1 measuring anxiety (HADS-A Scale) and the other measuring depression (HADS-D Scale). Each subscale was comprised of 7 items; participants assessed how each item applied to them on a scale of 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Subscores from HADS-A (Anxiety) and HADS-D (Depression) were not to be combined. The interpretation of each HADS subscales was as follows: 0-7 normal, 8-10 mild, 11-14 moderate and 15-21 severe.|Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.||units on a scale||Standard Error|Least Squares Mean
840643|NCT01332149|Secondary|Change From Baseline in HADS Anxiety Total Score at Endpoint|The HADS was a self-administered questionnaire that consisted of 2 subscales, 1 measuring anxiety (HADS-A Scale) and the other measuring depression (HADS-D Scale). Each subscale was comprised of 7 items; participants assessed how each item applied to them on a scale of 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Subscores from HADS-A (Anxiety) and HADS-D (Depression) were not to be combined. The interpretation of each HADS subscales was as follows: 0-7 normal, 8-10 mild, 11-14 moderate and 15-21 severe.|Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.||units on a scale||Standard Error|Least Squares Mean
840644|NCT01332149|Secondary|Baseline Hospital Anxiety and Depression Scale (HADS) Scores|The HADS was a self-administered questionnaire that consisted of 2 subscales, 1 measuring anxiety (HADS-A Scale) and the other measuring depression (HADS-D Scale). Each subscale comprised of 7 items; participants assessed how each item applied to them on a scale of 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Subscores from HADS-A (Anxiety) and HADS-D (Depression) were not to be combined. The interpretation of each HADS subscales was as follows: 0-7 normal, 8-10 mild, 11-14 moderate and 15-21 severe.|Baseline|All participants in the FAS population, consisting of all participants randomized to treatment that received at least 1 dose of study medication.||units on a scale||Standard Deviation|Mean
840645|NCT01332149|Secondary|Patient Global Impression of Change (PGIC) Score at Endpoint|The PGIC was a participant-rated global measure that provided a clinically relevant and easy to interpret account of a participant’s perception of the clinical importance of their own improvement or worsening during their involvement in a clinical study. Participants rated their overall improvement on a 7-point scale where scores ranged from 1 (very much improved) to 7 (very much worse).|Day 63 (Week 9)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.||units on a scale||Standard Error|Least Squares Mean
840646|NCT01332149|Secondary|Clinical Global Impression of Change (CGIC) at Endpoint|The CGIC was a clinician-rated global measure that provided a clinically relevant and easy to interpret account of a clinician’s perception of the clinical importance of the participant's improvement or worsening during their involvement in a clinical study. Clinicians rated the participant's overall improvement on a 7-point scale where scores ranged from 1 (very much improved) to 7 (very much worse).|Day 63 (Week 9)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.||units on a scale||Standard Error|Least Squares Mean
840647|NCT01332149|Secondary|Change From Baseline in MOS-Sleep Scale, Sleep Problems Index Score at Endpoint|The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The sleep problems index subscale score also ranged from 0 to 100, with lower scores indicating fewer sleep problems.|Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.||units on a scale||Standard Error|Least Squares Mean
840656|NCT01332149|Secondary|Change From Baseline in PPI Scale From the SF-MPQ at Endpoint|The PPI was part of the SF-MPQ scale and measured the participant's present pain intensity on a 6-point scale ranging from 0 (no pain) to 5 (excruciating).|Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.||units on a scale||Standard Error|Least Squares Mean
840648|NCT01332149|Secondary|Change From Baseline in MOS-Sleep Scale, Somnolence Score at Endpoint|The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The somnolence subscale score also ranged from 0 to 100, with lower scores indicating less somnolence.|Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.||units on a scale||Standard Error|Least Squares Mean
840649|NCT01332149|Secondary|Change From Baseline in MOS-Sleep Scale, Sleep Adequacy Score at Endpoint|The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The sleep adequacy subscale also ranged from 0 to 100, with higher scores indicating greater sleep adequacy.|Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.||units on a scale||Standard Error|Least Squares Mean
840650|NCT01332149|Secondary|Percentage of Participants Who Had Optimal Sleep at Endpoint|The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The MOS optimal sleep subscale was a binary outcome derived from the sleep quantity responses: the response was YES if sleep quantity was 7 or 8 hours per night.|Day 63 (Week 9)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.||percentage of participants|||Number
840651|NCT01332149|Secondary|Change From Baseline in MOS-Sleep Scale, Quantity of Sleep Score at Endpoint|The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The MOS Sleep Quantity sub-scale scores ranged from 0 to 24 (number of hours slept).|Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.||units on a scale||Standard Error|Least Squares Mean
840652|NCT01332149|Secondary|Change From Baseline in MOS-Sleep Scale, Awaken Short of Breath Score at Endpoint|The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The awaken short of breath subscale also ranged from 0 to 100, with lower scores indicating less difficulty in breathing.|Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.||units on a scale||Standard Error|Least Squares Mean
840653|NCT01332149|Secondary|Change From Baseline in MOS-Sleep Scale, Snoring Score at Endpoint|The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The snoring subscale score also ranged from 0 to 100, with lower scores indicating less snoring.|Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.||units on a scale||Standard Error|Least Squares Mean
840654|NCT01332149|Secondary|Change From Baseline in MOS-Sleep Scale, Sleep Disturbance Score at Endpoint|The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. For sleep disturbance, the subscale score also ranged from 0 to 100, with higher scores representing greater sleep disturbance.|Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.||units on a scale||Standard Error|Least Squares Mean
840655|NCT01332149|Secondary|Baseline Medical Outcomes Study (MOS)-Sleep Scale Scores|The MOS-Sleep Scale was a participant-rated instrument which assesses sleep quantity and quality with 12 items (7 subscale scores: sleep disturbance, snoring, awakening short of breath/with headache, sleep adequacy, somnolence, sleep quantity, optimal sleep; and a 9-item overall sleep problems index). Subscale scores total range: 0-100 (except sleep quantity [range 0-24 hours], optimal sleep [yes:1, no:0]). Higher scores=poorer sleep outcomes (except sleep quantity, adequacy, and optimal sleep).|Baseline|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. N=number of evaluable participants for each category||units on a scale||Standard Deviation|Mean
840683|NCT01332188|Secondary|Tearing at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Tearing was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of tearing score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)||units on a scale||Standard Deviation|Mean
840657|NCT01332149|Secondary|Change From Baseline in Pain VAS From the SF-MPQ at Endpoint|The VAS was part of the SF-MPQ scale and reflected the overall pain intensity score. The pain VAS was a horizontal line; 100 mm in length, was self-administered by the participant in order to rate pain from 0 (no pain) to 100 (worst possible pain).|Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.||units on a scale||Standard Error|Least Squares Mean
840658|NCT01332149|Secondary|Baseline Pain Visual Analogue Scale (VAS) and Present Pain Intensity (PPI) Scale|The VAS was part of the Short Form McGill Pain Questionnaire (SF-MPQ) scale and reflected the overall pain intensity score, The pain VAS was a horizontal line; 100 millimeters (mm) in length, was self-administered by the participant in order to rate pain from 0 (no pain) to 100 (worst possible pain). The PPI was part of the SF-MPQ scale and measured the participant's present pain intensity on a 6-point scale ranging from 0 (no pain) to 5 (excruciating).|Baseline|All participants in the FAS population, consisting of all participants randomized to treatment that received at least 1 dose of study medication.||units on a scale||Standard Deviation|Mean
840659|NCT01332149|Secondary|Change From Baseline in Short Form McGill Pain Questionnaire (SF-MPQ) Score at Weeks 1, 5, and 9|SF-MPQ was assessed according to the participant’s answer to the SF-MPQ questionnaire. The score for each composite scale (sensory, affective, and total) was derived by summing the reported intensity value for each item within a particular scale where None=0, Mild=1, Moderate=2, and Severe=3. The sensory score was the sum of the scores of the first 11 pain descriptors (throbbing, shooting, stabbing, sharp, cramping, gnawing, hot-burning, aching, heavy, tender, and splitting) and could range from 0-33. The affective score was the sum of the scores of the last 4 pain descriptors (tiring-exhausting, sickening, fearful, and punishing-cruel) and could range from 0-12. The total score was the sum of the scores of all 15 pain descriptors and could range from 0 to 45. Higher scores indicated greater pain.|Baseline; Weeks 1, 5, and 9|The FAS population consisted of all participants randomized to treatment that received at least 1 dose of study medication. N=number of evaluable participants at the specified time point. No inferential analyses were performed.||units on a scale||Standard Deviation|Mean
840660|NCT01332149|Secondary|Percentage of 30 Percent (%) Responders at Endpoint|The DPRS consists of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. A 30% responder was a participant who had 30% reduction or more in mean pain score at the end of the fixed dose phase (Day 63/Week 9) (Study Endpoint) compared to baseline.|End of fixed dose phase (Day 63/Week 9)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.||percentage of participants|||Number
840661|NCT01332149|Secondary|Change From Baseline in Weekly Mean Sleep Interference Score at Weeks 1 to 9|Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]). Participants were to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10. The weekly mean score was the sum of the daily scores divided by the number of diary entries during that week. The overall change is the average change from Weeks 1 to 9.|Baseline and weekly from Weeks 1 to 9|The FAS population consisted of all participants randomized to treatment that received at least 1 dose of study medication. N=number of evaluable participants at the specified time point.||units on a scale||Standard Error|Least Squares Mean
840662|NCT01332149|Secondary|Change From Baseline in Mean Sleep Interference Score at Endpoint|Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]). Participants were to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10. The mean endpoint score was obtained from the last 7 available scores of the daily diary while the participant was on study medication, up to and including the day after the last Week 9 (Day 63) dose.|Baseline and end of fixed dose phase (Day 63/Week 9)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.||units on a scale||Standard Error|Least Squares Mean
840663|NCT01332149|Secondary|Baseline Mean Sleep Interference Score|Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]). Participants were to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10.|Baseline|All participants in the Full Analysis Set (FAS) population, consisting of all participants randomized to treatment that received at least 1 dose of study medication.||units on a scale||Standard Deviation|Mean
840664|NCT01332149|Secondary|Change From Baseline in Weekly Mean Pain Score at Weeks 1 to 9|The DPRS consists of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. The weekly mean pain score was the sum of the daily scores divided by the number of diary entries during that week. The overall change is the average change from Weeks 1 to 9.|Baseline and weekly from Weeks 1 to 9|The FAS population consisted of all participants randomized to treatment that received at least 1 dose of study medication. N=number of evaluable participants at the specified time point.||units on a scale||Standard Error|Least Squares Mean
840665|NCT01332149|Primary|Change From Baseline in Mean Pain Score at Endpoint|The daily pain rating scale (DPRS) consists of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. The mean endpoint pain score was obtained from the last 7 available DPRS scores of the daily pain diary while the participant was on study medication, up to and including the day after the last Week 8 (Day 57) dose.|Baseline and end of fixed dose phase (Day 63/Week 9)/Early Termination (Study Endpoint)|All participants in the Full Analysis Set (FAS) population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The Last Observation Carried Forward (LOCF) method was used.||units on a scale||Standard Error|Least Squares Mean
840666|NCT01332149|Primary|Baseline Mean Pain Score|The daily pain rating scale (DPRS) consists of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10.|Baseline|All participants in the Full Analysis Set (FAS) population, consisting of all participants randomized to treatment that received at least 1 dose of study medication.||units on a scale||Standard Deviation|Mean
840667|NCT01332188|Secondary|Tolerability of Study Medication at Visit 3A|Subjects were asked to rate the comfort of the drop in each eye upon instillation, at 1 minute, and at 2 minutes after instillation of study medication. The assessment used a 10-point scale with 0 as very comfortable and 10 as very uncomfortable. Higher scores represent a worse outcome..|upon instillation, 1 minute and 2 minutes post instillation|Intent to Treat (ITT)||units on a scale||Standard Deviation|Mean
840668|NCT01332188|Secondary|Nasal Composite Score at Onset of Action (15 Minutes Post-dose)|A nasal composite score was summed for each patient based on the presence of at least one of the following four nasal symptoms on a 0-4 scale (0=none to 4=severe): rhinorrhea; nasal pruritus; ear or palate pruritus; and nasal congestion. The percentage of subjects with at least one nasal symptom present was calculated for each time point.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)||percentage of subjects|||Number
840669|NCT01332188|Secondary|Nasal Composite Score at Duration of Action (24 Hours Post-dose)|A nasal composite score was summed for each patient based on the presence of at least one of the following four nasal symptoms on a 0-4 scale (0=none to 4=severe): rhinorrhea; nasal pruritus; ear or palate pruritus; and nasal congestion. The percentage of subjects with at least one nasal symptom present was calculated for each time point.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)||percentage of subjects|||Number
840670|NCT01332188|Secondary|Nasal Composite Score at Duration of Action (16 Hours Post-dose)|A nasal composite score was summed for each patient based on the presence of at least one of the following four nasal symptoms on a 0-4 scale (0=none to 4=severe): rhinorrhea; nasal pruritus; ear or palate pruritus; and nasal congestion. The percentage of subjects with at least one nasal symptom present was calculated for each time point.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)||percentage of subjects|||Number
840671|NCT01332188|Secondary|Nasal Congestion at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Nasal Congestion was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Congestion score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)||units on a scale||Standard Deviation|Mean
840672|NCT01332188|Secondary|Nasal Congestion at Duration of Action (24 Hours Post-dose)|A treatment efficacy CAC was performed 24 hours after drop instillation. Nasal Congestion was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Congestion score for each time point was analyzed.|7, 15, 20 minutes post-CAC|||units on a scale||Standard Deviation|Mean
840673|NCT01332188|Secondary|Nasal Congestion at Onset of Action (16 Hours Post-dose)|A treatment efficacy CAC was performed 16 hours after drop instillation. Nasal Congestion was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Congestion score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)||units on a scale||Standard Deviation|Mean
840674|NCT01332188|Secondary|Ear or Palate Pruritus at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Ear or Palate Pruritus was assessed by the patient on a single 0-4 scale (0=none to 4=severe). Ear or Palate Pruritus score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)||units on a scale||Standard Deviation|Mean
840675|NCT01332188|Secondary|Ear or Palate Pruritus at Duration of Action (24 Hours Post-dose)|A treatment efficacy CAC was performed 24 hours after drop instillation. Ear or Palate Pruritus was assessed by the patient on a single 0-4 scale (0=none to 4=severe). Ear or Palate Pruritus score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)||units on a scale||Standard Deviation|Mean
840676|NCT01332188|Secondary|Ear or Palate Pruritus at Duration of Action (16 Hours Post-dose)|A treatment efficacy CAC was performed 16 hours after drop instillation. Ear or Palate Pruritus was assessed by the patient on a single 0-4 scale (0=none to 4=severe). Ear or Palate Pruritus score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)||units on a scale||Standard Deviation|Mean
840677|NCT01332188|Secondary|Nasal Pruritus at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Nasal Pruritus was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Pruritus score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)||units on a scale||Standard Deviation|Mean
840678|NCT01332188|Secondary|Nasal Pruritus at Duration of Action (24 Hours Post-dose)|A treatment efficacy CAC was performed 24 hours after drop instillation. Nasal Pruritus was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Pruritus score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)||units on a scale||Standard Deviation|Mean
840679|NCT01332188|Secondary|Nasal Pruritus at Duration of Action (16 Hours Post-dose)|A treatment efficacy CAC was performed 16 hours after drop instillation. Nasal Pruritus was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Pruritus score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)||units on a scale||Standard Deviation|Mean
840680|NCT01332188|Secondary|Rhinorrhea at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Rhinorrhea was assessed by the patient on a 0-4 scale (0=none to 4=severe). Rhinorrhea score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)||units on a scale||Standard Deviation|Mean
840681|NCT01332188|Secondary|Rhinorrhea at Duration of Action (24 Hours Post-dose)|A treatment efficacy CAC was performed 24 hours after drop instillation. Rhinorrhea was assessed by the patient on a 0-4 scale (0=none to 4=severe). Rhinorrhea score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)||units on a scale||Standard Deviation|Mean
840682|NCT01332188|Secondary|Rhinorrhea at Duration of Action (16 Hours Post-dose)|A treatment efficacy CAC was performed 16 hours after drop instillation. Rhinorrhea was assessed by the patient on a 0-4 scale (0=none to 4=severe). Rhinorrhea score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)||units on a scale||Standard Deviation|Mean
840686|NCT01332188|Secondary|Eyelid Swelling at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Eyelid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of eyelid swelling score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)||units on a scale||Standard Deviation|Mean
840687|NCT01332188|Secondary|Eyelid Swelling at Duration of Action (24 Hours Post-dose)|A treatment efficacy CAC was performed 24 hours after drop instillation. Eyelid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of eyelid swelling score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)||units on a scale||Standard Deviation|Mean
840688|NCT01332188|Secondary|Eyelid Swelling at Duration of Action (16 Hours Post-dose)|A treatment efficacy CAC was performed 16 hours after drop instillation. Eyelid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of eyelid swelling score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)||units on a scale||Standard Deviation|Mean
840689|NCT01332188|Secondary|Chemosis at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Chemosis was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of chemosis score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)||units on a scale||Standard Deviation|Mean
840690|NCT01332188|Secondary|Chemosis at Duration of Action (24 Hours Post-dose)|A treatment efficacy CAC was performed 24 hours after drop instillation. Chemosis was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of chemosis score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)||units on a scale||Standard Deviation|Mean
840691|NCT01332188|Secondary|Chemosis at Duration of Action (16 Hours Post-dose)|A treatment efficacy CAC was performed 16 hours after drop instillation. Chemosis was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of chemosis score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)||units on a scale||Standard Deviation|Mean
840692|NCT01332188|Secondary|Episcleral Redness at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Episcleral Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of episcleral redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)||units on a scale||Standard Deviation|Mean
840693|NCT01332188|Secondary|Episcleral Redness at Duration of Action (24 Hours Post-dose)|A treatment efficacy CAC was performed 24 hours after drop instillation. Episcleral Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of episcleral redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)||units on a scale||Standard Deviation|Mean
840694|NCT01332188|Secondary|Episcleral Redness at Duration of Action (16 Hours Post-dose)|A treatment efficacy CAC was performed 16 hours after drop instillation. Episcleral Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of episcleral redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)||units on a scale||Standard Deviation|Mean
840695|NCT01332188|Secondary|Ciliary Redness at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Ciliary Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ciliary redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT). Number of analyzed subjects differ due to subject discontinuation during the study.||units on a scale||Standard Deviation|Mean
840696|NCT01332188|Secondary|Ciliary Redness at Duration of Action (24 Hours Post-dose)|A treatment efficacy CAC was performed 24 hours after drop instillation. Ciliary Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ciliary redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)||units on a scale||Standard Deviation|Mean
840697|NCT01332188|Secondary|Ciliary Redness at Duration of Action (16 Hours Post-dose)|A treatment efficacy CAC was performed 16 hours after drop instillation. Ciliary Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ciliary redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)||units on a scale||Standard Deviation|Mean
840698|NCT01332188|Primary|Conjunctival Redness at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)||units on a scale||Standard Deviation|Mean
840699|NCT01332188|Primary|Conjunctival Redness at Duration of Action (24 Hours Post-dose)|A treatment efficacy CAC was performed 24 hours after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)||units on a scale||Standard Deviation|Mean
840700|NCT01332188|Primary|Conjunctival Redness at Duration of Action (16 Hours Post-dose)|A treatment efficacy CAC was performed 16 hours after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)||units on a scale||Standard Deviation|Mean
840701|NCT01332188|Primary|Ocular Itching at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.|3, 5, 7 minutes post-CAC|Intent to Treat (ITT)||units on a scale||Standard Deviation|Mean
840702|NCT01332188|Primary|Ocular Itching at Duration of Action (24 Hours Post-dose)|A treatment efficacy CAC was performed 24 hours after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.|3, 5, 7 minutes post-CAC|Intent to Treat (ITT)||units on a scale||Standard Deviation|Mean
840703|NCT01332188|Primary|Ocular Itching at Duration of Action (16 Hours Post-dose)|A treatment efficacy CAC was performed 16 hours after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.|3, 5, 7 minutes post-CAC|Intent to Treat (ITT)||units on a scale||Standard Deviation|Mean
840704|NCT01332227|Secondary|Mean Changes in Fasting Lipid Levels From Baseline to Week 48|LD=low-density lipoprotein; HDL=high-density lipoprotein.|From Baseline to Week 48|All participants who received study drug||mg/dL||Standard Error|Mean
840705|NCT01332227|Secondary|Number of Patients With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Treatment-emergent Adverse Events (AEs) Leading to Discontinuation, and Treatment-emergent AEs|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or unknown relationship to study drug.|Day 1 to Week 48|All participants who received study drug||Particpants|||Number
840706|NCT01332227|Secondary|Number of Participants With Genotypable/Phenotypable Isolates, Emergent Genotypic Substitutions in Patients With Genotypable Isolates, and Phenotypic Resistance in Patients With Phenotypable Isolates at Week 48|Viral genotypic and phenotypic resistance profiles were assessed for virologic rebound (HIV-1 RNA level ≥40 c/mL). Only patients with HIV-1 RNA levels ≥500 c/mL met the criteria for resistance testing. Genotypic substitutions at baseline were summarized for virologic rebound. The genotypic resistance profile presented patients with genotypable isolates, those with protease inhibitor substitutions from genotypable isolates, those with integrase substitutions from genotypable isolates, and those with selected reverse transcriptase substitutions from genotypable isolates using the most current version of the International AIDS Society-USA list and Stanford HIV Drug Resistance Database. Newly emergent genotypic substitutions were summarized analogously for virologic rebound without baseline phenotypic resistance to atazanavir, ritonavir, or raltegravir, using all on-treatment isolates. pts=patients|Day 1 to Week 48|Participants with virologic rebound||Participants|||Number
840707|NCT01332227|Secondary|Number of Participants With Genotypable/Phenotypable Isolates, Emergent Genotypic Substitutions in Patients With Genotypable Isolates, and Phenotypic Resistance in Patients With Phenotypable Isolates at Week 24|Viral genotypic and phenotypic resistance profiles were assessed for virologic rebound (HIV-1 RNA level ≥40 c/mL). Only patients with HIV-1 RNA levels ≥500 c/mL met the criteria for resistance testing. Genotypic substitutions at baseline were summarized for virologic rebound. The genotypic resistance profile presented patients with genotypable isolates, those with protease inhibitor substitutions from genotypable isolates, those with integrase substitutions from genotypable isolates, and those with selected reverse transcriptase substitutions from genotypable isolates using the most current version of the International AIDS Society-USA list and Stanford HIV Drug Resistance Database. Newly emergent genotypic substitutions were summarized analogously for virologic rebound without baseline phenotypic resistance to atazanavir, ritonavir, or raltegravir, using all on-treatment isolates. pts=patients|Day 1 to Week 24|Patients who received study drug, who had an HIV-1 RNA measurement at the analysis week and who experienced virologic rebound.||Participants|||Number
840708|NCT01332227|Secondary|Number of Participants With Virologic Rebound at Weeks 24 and 48|Viral genotypic and phenotypic resistance profiles were assessed for virologic rebound (HIV-1 RNA level ≥40 c/mL). Only patients with HIV-1 RNA levels ≥500 c/mL met the criteria for resistance testing. Genotypic substitutions at baseline were summarized for virologic rebound. The genotypic resistance profile presented patients with genotypable isolates, those with protease inhibitor substitutions from genotypable isolates, those with integrase substitutions from genotypable isolates, and those with selected reverse transcriptase substitutions from genotypable isolates using the most current version of the International AIDS Society-USA list and Stanford HIV Drug Resistance Database. Newly emergent genotypic substitutions were summarized analogously for virologic rebound without baseline phenotypic resistance to atazanavir, ritonavir, or raltegravir, using all on-treatment isolates.|Day 1 to Weeks 28 and 48|All patients who received study drug and who had an HIV-1 RNA measurement at the analysis week.||Participants|||Number
840709|NCT01332227|Secondary|Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 48|Percentages of patients with HIV-1 RNA levels <40 c/mL were summarized at each scheduled visit. Longitudinal plots were created to display proportion versus visit week through Weeks 24 and 48 with error bars representing 95% confidence intervals.|From Day 1 to Week 48|All patients who received study drug and who had an HIV-1 RNA measurement at the analysis week.||Percentage of participants||95% Confidence Interval|Number
840710|NCT01332227|Primary|Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 24|HIV-1 RNA level was measured with the Abbott m2000rt® polymerase chain reaction assay. Response rates were assessed using an intent-to-treat algorithm, with numerator representing patients meeting the response criteria, and denominator representing all randomized patients. Randomized patients not meeting the criteria for treatment failure (eg, discontinuation of study therapy or virologic rebound at or before Week 24) were considered responders. Virologic rebound was defined as 2 consecutive on-treatment HIV-1 RNA levels ≥40 c/mL or the last on-treatment HIV-1 RNA level ≥40 c/mL followed by discontinuation. Patients who experienced treatment failure or had missing Week 24 HIV-1 RNA levels were considered failures. RNA=ribonucleic acid; HIV=human immunodeficiency virus.|From Day 1 to Week 24|All patients who received study drug and who had an HIV-1 RNA measurement at the analysis week.||Percentage of participants||95% Confidence Interval|Number
840711|NCT01332253|Secondary|Blood Loss During Surgery|Amount of Blood Lost During Surgery in milliliters|End of Surgery|Blood loss during surgery in milliliters||milliliters||Standard Deviation|Mean
840712|NCT01332253|Secondary|Parental Satisfaction With Vomiting Control in the Post-Operative Period.|"To evaluate the secondary objective of pain, parental satisfaction during the post-operative period will be measured with regards to vomiting control. The Parental Satisfaction Survey asked the parent to base their response on their child's management from the time they arrive in the recovery room until they were discharged. Question 3 asked How satisfied were you with your child's vomiting management during the study?"|Discharge|Summary of Satisfaction Post-Procedure with Vomiting Control.||participants|||Number
840713|NCT01332253|Secondary|Parent Satisfaction With Regards to Nausea Management Post Procedure.|"To evaluate the secondary objective of pain, parental satisfaction during the post-operative period will be measured with regards to nausea management. The Parental Satisfaction Survey asked the parent to base their response on their child's management from the time they arrive in the recovery room until they were discharged. Question 2 asked How satisfied were you with your child's nausea management during the study?"|Discharge|Summary of Satisfaction Post-Procedure with nausea management during the study||participants|||Number
840714|NCT01332253|Secondary|Parent Satisfaction With Regards to Pain Management Post Procedure.|"To evaluate the secondary objective of pain, parental satisfaction during the post-operative period will be measured with regards to pain management. The Parental Satisfaction Survey asked the parent to base their response on their child's management from the time they arrive in the recovery room until they were discharged. Question 1 asked How satisfied were you with your child's pain management at the time of discharge?"|Discharge|Summary of Parent Satisfaction Post-Procedure with Pain Management at the time of discharge?||participants|||Number
840715|NCT01332253|Secondary|Time to Swallow Post Procedure.|Swallowing will be assessed every 15 minutes following arrival to the recovery room; the time to first swallow will be recorded.|every 15 minutes until able to swallow|||hours||Standard Error|Mean
840716|NCT01332253|Secondary|Time to Discharge Post Procedure.|To evaluate the secondary objective of pain, the time to participant discharge will be measured.|Discharge|||hours||Standard Error|Mean
840717|NCT01332253|Secondary|Postoperative Pain as Measured by the Visual Analog Scale (VAS) 120 Minutes Post-procedure.|"To evaluate the secondary objective of pain, the patient's self-reported pain at 120 minutes post-procedure will be measured using a VAS scale. The VAS is a continuous scale made up of a horizontal line, 100 mm in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The subject is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the No Pain anchor and the subject's mark. The score would be between 0 and 100. A lower score represents less pain while a higher score represents more pain."|120 minutes post-procedure|Patient reported pain was evaluated utilizing a visual analog scale (VAS) 120 minutes post-procedure.||millimeters||Standard Deviation|Mean
840718|NCT01332253|Secondary|Postoperative Pain as Measured by the Visual Analog Scale (VAS) 90 Minutes Post-procedure.|"o evaluate the secondary objective of pain, the patient's self-reported pain at 90 minutes post-procedure will be measured using a VAS scale. The VAS is a continuous scale made up of a horizontal line, 100 mm in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The subject is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the No Pain anchor and the subject's mark. The score would be between 0 and 100. A lower score represents less pain while a higher score represents more pain."|90 minutes post-procedure|Patient reported pain was evaluated utilizing a visual analog scale (VAS) 90 minutes post-procedure.||millimeters||Standard Deviation|Mean
840719|NCT01332253|Secondary|Postoperative Pain as Measured by the Visual Analog Scale (VAS) 60 Minutes Post-procedure.|"To evaluate the secondary objective of pain, the patient's self-reported pain at 60 minutes post-procedure will be measured using a VAS scale. The VAS is a continuous scale made up of a horizontal line, 100 mm in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The subject is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the No Pain anchor and the subject's mark. The score would be between 0 and 100. A lower score represents less pain while a higher score represents more pain."|60 minutes post-procedure|Patient reported pain was evaluated utilizing a visual analog scale (VAS) 60 minutes post-procedure.||millimeters||Standard Deviation|Mean
840720|NCT01332253|Secondary|Postoperative Pain as Measured by the Visual Analog Scale (VAS) 30 Minutes Post-procedure.|"The patient's self-reported pain at 30 minutes post-procedure will be measured using a VAS scale. The VAS is a continuous scale made up of a horizontal line, 100 mm in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The subject is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the No Pain anchor and the subject's mark. The score would be between 0 and 100. A lower score represents less pain while a higher score represents more pain."|30 minutes post-procedure|Patient reported pain was evaluated utilizing a visual analog scale (VAS) 30 minutes post-procedure.||millimeters||Standard Deviation|Mean
840721|NCT01332253|Primary|Number of Doses of Fentanyl Administered in the Postoperative Period Prior to Discharge.|To evaluate the primary objective of reduced fentanyl use in the post-operative period, the number of fentanyl doses (0.5 mcg/kg IV) administered in the post-operative period prior to discharge will be measured.|4 hours|||fentanyl doses||Standard Deviation|Mean
840722|NCT01332292|Primary|Change From Baseline in the Indicated Electrocardiographic (ECG) Parameters at the Indicated Time Points on Day 14 of the Respective Treatment Period|PR, QRS, QT, QTcB, QTcF, and RR were measured at Baseline and Day 14 of the respective treatment period. Baseline is defined as the pre-dose measurement at Day 1 for each period. Change from Baseline was calculated as the value at Day 14 minus the Baseline value. QTcB is the QT duration corrected for heart rate by Bazett’s formula. QTcF is the QT duration corrected for heart rate by Fridericia’s formula.|Baseline and Day 14 of the respective treatment period (up to Study Day 44)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||milliseconds (msec)||Standard Deviation|Mean
840723|NCT01332292|Secondary|Ex-throat Dose (ETD) and ETD <2 Microns on Days 1 and 14 of the Respective Treatment Period|The ex-throat dose (ETD) and the “nominal ETD” is the mass (micrograms) of active investigational material that passes beyond the throat, nominal being the mean.The recorded inhalation profiles of the participants and the mouth-throat (oropharyngeal) models of the sizes that approximated to pharyngometry measurements of the participants were used in conjunction with the electronic Lung (eLung) for in vitro assessment. The eLung is a breathing simulator that replicates the selected inhalation profile with an active inhaler placed at the lips end of the selected ororpharyngeal model. After the dose is emitted from the inhaler, the analysis and assay of throat deposition and material passing beyond the throat was used to derive the nominal, minimum, and maximum predicted ETD and ETD <2 microns.|Day 1 and Day 14 of the respective treatment period|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||micrograms||Standard Deviation|Mean
840724|NCT01332292|Secondary|Total Emitted Dose (TED) on Days 1 and 14 of the Respective Treatment Period|The total emitted dose (TED) is defined as the mass (micrograms) of the nominal dose that passes beyond the throat. The recorded inhalation profiles of the participants and the mouth-throat (oropharyngeal) models of the sizes that approximated to pharyngometry measurements of the participants were used in conjunction with the electronic Lung (eLung) for in vitro assessment. The eLung is a breathing simulator that replicates the selected inhalation profile with an active inhaler placed at the lips end of the selected ororpharyngeal model. After the dose is emitted from the inhaler, the analysis and assay of throat deposition and material passing beyond the throat was used to derive the nominal, minimum, and maximum predicted total emitted dose.|Day 1 and Day 14 of the respective treatment period|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||micrograms||Standard Deviation|Mean
840725|NCT01332292|Secondary|Peak Pressure Drop on Days 1 and 14 of the Respective Treatment Period|During the inhalation profile assessment, participants inhaled through a mouthpiece from a device with a similar resistance to the dry powder inhaler used for this study. Peak pressure drop is defined as the maximum pressure drop (kilopascal [kPa]) achieved during inhalation across the resistance of the inhaler. The pressure drop during the inhalation was measured, and the inhalation profiles (pressure drop versus time profile) of the participants were obtained. The mean of the two inhalation profile measurements was calculated for each day (Days 1 and 14 of the respective treatment period), and used for subsequent modeling and prediction of dose emission attributes.|Day 1 and Day 14 of the respective treatment period|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Kilopascal (kpa)||Standard Deviation|Mean
840726|NCT01332292|Secondary|Inhaled Volume on Days 1 and 14 of the Respective Treatment Period|"During the inhalation profile assessment, participants inhaled through a mouthpiece from a device with a similar resistance to the dry powder inhaler used for this study. Inhaled volume is defined as the volume of air (Liters) inhaled during the inhalation across the resistance of the inhaler.
The pressure drop during the inhalation was measured, and the inhalation profiles (pressure drop versus time profile) of the participants were obtained. The mean of the two inhalation profile measurements was used for each day (Days 1 and 14 of the respective treatment period), and the inhalaled volume was determined."|Day 1 and Day 14 of the respective treatment period|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Liters||Standard Deviation|Mean
840727|NCT01332292|Secondary|Inhalation Time on Days 1 and 14 of the Respective Treatment Period|During the inhalation profile assessment, participants inhaled through a mouthpiece from a device with a similar resistance to the dry powder inhaler used for this study. Inhalation time is defined as the duration of the inhalation(s) when inhaling across the resistance of the inhaler. The pressure drop during the inhalation was measured, and the inhalation profiles (pressure drop versus time profile) of the participants were obtained. The mean of the two inhalation profile measurements was used for each day (Days 1 and 14 of the respective treatment period), and the inhalation time was determined.|Day 1 and Day 14 of the respective treatment period|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Seconds||Standard Deviation|Mean
840728|NCT01332292|Secondary|Average Flow Rate and Peak Inspiratory Flow Rate (PIFR) on Days 1 and 14 of the Respective Treatment Period|During the inhalation profile assessment, participants inhaled through a mouthpiece from a device with a similar resistance to the dry powder inhaler used for this study. Average flow rate is defined as the average inspiratory flow rate (Liters [L]/min) across the inhalation profile when inhaling across the resistance of the inhaler. PIFR is defined as the Peak Inspiratory Flow Rate (L/min) of the inhalation profile when inhaling across the resistance of the inhaler.The pressure drop during the inhalation was measured, and the inhalation profiles (pressure drop versus time profile) of the participants were obtained. The mean of the two inhalation profile measurements was used for each day (Days 1 and 14 of the respective treatment period), and the average flow rate and PIFR were determined.|Day 1 and Day 14 of the respective treatment period|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Liters per minute (L/min)||Standard Deviation|Mean
840729|NCT01332292|Secondary|Oropharyngeal Volume on Days 1 and 14 of the Respective Treatment Period|During the pharyngometry assessment, participants inhaled through a wavetube, which had a mouthpiece with the same dimensions as the mouthpiece on the dry powder inhaler used for this study. This technique was used to measure the size of the throat and mouth (oropharynx) in the form of pharyngograms. Oropharyngeal volume is defined as the volume (cm^3) of the mouth and throat estimated to be from the lips to the larynx. Pharyngometry data were recorded for each day (Days 1 and 14 of the respective treatment period) using the mean of four measurements (pharyngograms), and the average oropharyngeal cross-sectional area was calculated.|Days 1 and 14 of the respective treatment period|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||cubic centimeters (cm^3)||Standard Deviation|Mean
840761|NCT01332318|Secondary|Number of Participants in Each Category of the Participant-Rated Clinician Global Impression of Improvement (CGI-I) Scale at Day 14|"The participant-rated CGI-I scale is a self-rated assessment designed to allow participants to rate the change of their disease severity over time based on a seven-point scale, with a score of 1 being “very much improved” and a score of 7 being “very much worse."|Day 14|"Modified Intent-to-Treat (MITT) Population. Participants in the GEn placebo and DPH placebo and the GEn placebo and DPH 50 mg on Day 16 arms have been combined into the GEn placebo and DPH group."||participants|||Number
840730|NCT01332292|Secondary|Distance of Assessment on Days 1 and 14 of the Respective Treatment Period|During the pharyngometry assessment, participants inhaled through a wavetube, which had a mouthpiece with the same dimensions as the mouthpiece on the dry powder inhaler used for this study. This technique was used to measure the size of the throat and mouth (oropharynx) in the form of pharyngograms. Distance of assessment is defined as the distance (length measured in centimeters [cm]) estimated to be from the lips to the larynx. Pharyngometry data were recorded for each day (Days 1 and 14 of each treatment period) using the mean of four measurements (pharyngograms), and the average oropharyngeal cross-sectional area was calculated.|Days 1 and 14 of the respective treatment period|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||centimeters (cm)||Standard Deviation|Mean
840731|NCT01332292|Secondary|Average Oropharyngeal Cross-sectional Area on Days 1 and 14 of the Respective Treatment Period|During the pharyngometry assessment, participants inhaled through a wavetube, which had a mouthpiece with the same dimensions as the mouthpiece on the dry powder inhaler used for this study. This technique was used to measure the size of the throat and mouth (oropharynx) in the form of pharyngograms. Pharyngometry data were recorded for each day (Days 1 and 14 of the respective treatment period) using the mean of four measurements (pharyngograms), and the average oropharyngeal cross-sectional area was calculated.|Days 1 and 14 of the respective treatment period|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||centimeters squared (cm^2)||Standard Deviation|Mean
840732|NCT01332292|Secondary|Serum Cortisol Weighted Mean (0–12 Hours) on Day 14 of the Respective Treatment Period|Serum cortisol weighted mean was determined for each participant over the time period 0-12 hours on Day 14 of the respective treatment period. Samples were collected at the following times: pre-dose; 30 minutes, 1, 2, 4, 7, and 12 hours post-dose on Day 14 of the respective treatment period.|Day 14 of the respective treatment period|All Subjects Population. Only those participants available at the specified time point were analyzed.||nanomoles per Liter||95% Confidence Interval|Geometric Mean
840733|NCT01332292|Secondary|Tmax and t at Day 14 of the Respective Treatment Period|tmax is defined as the time to reach the observed maximum concentration, and t is defined as the time of the last observed quantifiable concentration on Day 14 of the respective treatment period. Samples were collected at the following times: pre-dose; 30 minutes, 1, 2, 4, 7, and 12 hours post-dose on Day 14 of the respective treatment period.|Day 14 of the respective treatment period|PK Population. Only those participant who had quantifiable FF concentrations were analyzed.||hours||Standard Deviation|Mean
840734|NCT01332292|Secondary|Cmax on Day 14 of the Respective Treatment Period|Cmax is defined as the maximum observed concentration on Day 14 of the respective treatment period. Samples were collected at the following times: pre-dose; 30 minutes, 1, 2, 4, 7, and 12 hours post-dose on Day 14 of the respective treatment period.|Day 14 of the respective treatment period|PK Population||picograms per milliliter (pg/mL)||95% Confidence Interval|Geometric Mean
840735|NCT01332292|Secondary|AUC(0-t) on Day 14 of the Respective Treatment Period|Area under the concentration-time (AUC(0-t)) curve from time zero (pre-dose) to the last time of quantifiable concentration of FF on Day 14 of the respective treatment period was measured. Samples were collected at the following times: pre-dose; 30 minutes, 1, 2, 4, 7, and 12 hours post-dose on Day 14 of the respective treatment period. Due to non-quantifiable values, it was not possible to derive AUC(0-12).|Day 14 of the respective treatment period|Pharmacokinetic (PK) Population: all participants in the All Subjects Population for whom a PK sample was obtained and analyzed||picograms*hour per milliliter (pg*hr/mL)||95% Confidence Interval|Geometric Mean
840736|NCT01332292|Primary|Heart Rate at Baseline and Day 14 of the Respective Treatment Period|Heart rate (HR) was measured at Baseline and Day 14 of the respective treatment period. Baseline is defined as the pre-dose measurement at Day 1 for each period.|Baseline and Day 14 of the respective treatment period (up to Study Day 44)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Beats per minute||Standard Deviation|Mean
840737|NCT01332292|Primary|Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Baseline and Day 14 of the Respective Treatment Period|SBP and DBP were measured at Baseline and Day 14 of the respective treatment period. Baseline is defined as the pre-dose measurement at Day 1 for each period.|Baseline and Day 14 of the respective treatment period (up to Study Day 44)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Millimeters of mercury (mmHg)||Standard Deviation|Mean
840738|NCT01332292|Primary|Peak Expiratory Flow on Day 1 and Day 14 of the Respective Treatment Period|Peak Expiratory Flow (PEF) is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF is calculated as the maximum of three readings taken at each timepoint for each participant. Baseline is defined as the maximum pre-dose measurement at Day 1 for each period.|Day 1 and Day 14 of the respective treatment period (up to Study Day 44)|All Subjects Population, Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||liters/minute||Standard Deviation|Mean
840739|NCT01332292|Primary|Total Bilirubin, Creatinine, and Uric Acid Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of total bilirubin, creatinine, and uric acid at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 44)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Micromoles per liter (µmol/L)||Standard Deviation|Mean
840740|NCT01332292|Primary|Calcium, Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of calcium, chloride, carbon dioxide content/bicarbonate (CO2/BI), glucose, potassium, sodium, and urea/BUN at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 44)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Millimoles per liter (mmol/L)||Standard Deviation|Mean
840741|NCT01332292|Primary|Albumin and Total Protein Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of albumin and total protein at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 44)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Grams per liter||Standard Deviation|Mean
840742|NCT01332292|Primary|Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), and Gamma Glutamyl Transferase (GGT) Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of ALT, ALP, AST, and GGT at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 44)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||International units per liter (IU/L)||Standard Deviation|Mean
840743|NCT01332292|Primary|Mean Corpuscle Hemoglobin (MCH) Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of MCH at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 44)|All Subjects Population. Only those participants available at the specified time points were analyzed.||10^12 picograms (pg) per cell||Standard Deviation|Mean
840744|NCT01332292|Primary|Mean Corpuscle Volume (MCV) Value at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of MCV at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 44)|All Subjects Population. Only those participants available at the specified time points were analyzed .||10^15 femtoliters (fL) per cell||Standard Deviation|Mean
840745|NCT01332292|Primary|Hematocrit Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of hematocrit at Day 14 of the respective treatment period. Hematocrit is a measure of the percentage of the volume of the whole blood that is composed of red blood cells, as determined by separation of red blood cells from the plasma (usually by centrifugation).|Day 14 of the respective treatment period (up to Study Day 44)|All Subjects Population. Only those participants available at the specified time points were analyzed.||percentage of red blood cells in blood||Standard Deviation|Mean
840746|NCT01332292|Primary|Reticulocyte and Red Blood Cell (RBC) Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of reticulocyte and RBCs at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 44)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||10^12 cells per liter (TI/L)||Standard Deviation|Mean
840747|NCT01332292|Primary|Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of hemoglobin and MCHC at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 44)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Grams per liter (g/L)||Standard Deviation|Mean
840748|NCT01332292|Primary|Basophil, Eosinophil, Lymphocyte, Monocyte, Total Neutrophil, Platelet, and White Blood Cell Count Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelets, and white blood cell (WBC) count at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 44)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||10^9 cells per liter (GI/L)||Standard Deviation|Mean
840749|NCT01332292|Primary|Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in deciding whether reporting is appropriate in other situations. Refer to the General Adverse AE/SAE module for a complete list of AEs and SAEs.|From the start of study medication until Week 11 (Visit 6)/Early Withdrawal|All Subjects Population: all participants who received at least one dose of study medication||participants|||Number
840750|NCT01332305|Primary|Mean AUCss|The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUCss is the area under the curve during the steady-state period. The AUCss is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. AUCss used concentration data from 0 to 24 hours at steady-state for Weeks 4 and 12.|Weeks 4 and 12|Safety Population. Placebo participants were not included in the PK assessments, as they had no exposure to GEn. Of participants who completed the study, some were not included at Week 12 (sample not taken or below limit of quantitation).||ng*hour/ml||Standard Deviation|Mean
840751|NCT01332305|Primary|Mean Tmax and T1/2|Tmax is defined as the time to the maximum or “peak” concentration of a drug observed after multiple administration. T1/2 is defined as the time to when half of the total amount of a particular substance is eliminated from the body.|Weeks 4 and 12|Safety Population. Placebo participants (par.) were not included in the PK assessments, as they had no exposure to GEn. At W4, there were two par. excluded from the T1/2, as a result of no sample taken or a PK profile not possible. Of par. who completed the study, some were not included at W12 (sample not taken or below limit of quantitation).||hours||Standard Deviation|Mean
840752|NCT01332305|Primary|Mean Css, Max and Css, Min|Css, max is defined as the maximum or “peak” concentration of a drug observed after multiple administration, at steady state. Css, max is one of the parameters of particular use in estimating the bioavailability of drugs, by measuring the total amount of drug absorbed. Css, min is defined as the minimum concentration of a drug observed after its administration, in steady state. ng, nanograms; PK, pharmacokinetic; W, week; BLQ, below limit of quantitation.|Weeks 4 and 12|Safety Population: all participants (par.) who were randomized and received at least one (or any portion of a) dose of study drug. Population was analyzed as randomized. Placebo par. had no exposure to GEn and were not included in the PK assessments. Of par. who completed the study, some were not included at W12 (sample not taken or BLQ).||nanograms per milliliter (ng/ml)||Standard Deviation|Mean
840753|NCT01332318|Secondary|Mean Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) in the Pittsburgh Sleep Diary (PghSD) Sleep Quality|"The PghSD assessed a participant's previous night's sleep. Sleep quality was assessed using a Visual Analogue Scale (VAS). Participants indicated their sleep quality by marking a vertical line on a horizontal scale anchored by responses very bad and very good. VAS score was determined by measuring the distance in millimeters (mm) from the left hand end of the line to the point that the participant marked. Scores ranged from 0 to 100 mm with higher scores indicating better sleep quality and lower scores indicating worse sleep quality."|Baseline (Day -1and 1) and Days 14, 15, and 16|"Modified Intent-to-Treat (MITT) Population. Participants in the GEn placebo and DPH placebo and the GEn placebo and DPH 50 mg on Day 16 arms have been combined into the GEn placebo and DPH group. The number of participants assessed for each PghSD question at each study day varies due to incomplete/missing data."||millimeters||Standard Deviation|Mean
840754|NCT01332318|Secondary|Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) in the Pittsburgh Sleep Diary (PghSD) Total Sleep Time Item|The PghSD assessed a participant's previous night's sleep. Change from baseline was calculated as the Day 14 (in the evening), 15 (in the morning after dose), and 16 (at Tmax)value minus the Baseline (Days -1 and 1) value. Total sleep time is expressed in hours.|Baseline (Days -1 and 1) and Days 14, 15, and 16|"Modified Intent-to-Treat (MITT) Population. Participants in the GEn placebo and DPH placebo and the GEn placebo and DPH 50 mg on Day 16 arms have been combined into the GEn placebo and DPH group. The number of participants assessed for each PghSD question at each study day varies due to incomplete/missing data."||hours||Standard Deviation|Mean
840755|NCT01332318|Secondary|Mean Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) on the Pittsburgh Sleep Diary (PghSD) Sleep Onset Items|The PghSD assessed participant's previous night's sleep. Change from baseline was calculated as the Day 14 (in the evening), 15 (in the morning), and 16 (at Tmax of GEn and DPH) value minus the Baseline (Days -1 and 1) value. Latency to sleep onset (time to fall asleep) and wake time after sleep onset are expressed in minutes.|Baseline (Days -1and 1) and Days 14, 15, and 16|"Modified Intent-to-Treat (MITT) Population. Participants in the GEn placebo and DPH placebo and the GEn placebo and DPH 50 mg on Day 16 arms have been combined into the GEn placebo and DPH group. The number of participants assessed for each PghSD question at each study day varies due to incomplete/missing data."||minutes||Standard Deviation|Mean
840756|NCT01332318|Secondary|Number of Participants With the Indicated Post Sleep Questionnaire (PSQ) Responses at Day 14|The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep.|Day 14|"Modified Intent-to-Treat (MITT) Population. Participants in the GEn placebo and DPH placebo and the GEn placebo and DPH 50 mg on Day 16 arms have been combined into the GEn placebo and DPH group."||participants|||Number
840757|NCT01332318|Secondary|Number of Participants With no Reported RLS Symptoms During Each of the 4-hour Periods From the 24-hour RLS Record at Day 14|The 24-Hour RLS Record is a diary in which participants report the presence and severity of RLS symptoms (none, mild, moderate, or severe) for a 24-hour period, in 30-minute increments. The period was divided into 7 four-hour intervals (8 AM to 12 PM, 12 PM to 4 PM, 4 PM to 8 PM, 6 PM to 10 PM, 8 PM to 12 Midnight, Midnight to 4 AM, and 4 AM to 8 AM).|Day 14|"Modified Intent-to-Treat (MITT) Population. Participants in the GEn placebo and DPH placebo and the GEn placebo and DPH 50 mg on Day 16 arms have been combined into the GEn placebo and DPH group."||participants|||Number
840758|NCT01332318|Secondary|Percentage of Participants With no Reported RLS Symptoms During the 24-hour RLS Record at Day 14|The 24-Hour RLS Record is a diary in which participants report the presence and severity of RLS symptoms (none, mild, moderate, or severe) for a 24-hour period, in 30-min increments beginning at 8AM on the day prior to the visit.|Day 14|Modified Intent-to-Treat (MITT) Population. Participants in the||percentage of participants|||Number
840759|NCT01332318|Secondary|Median Time to Onset of a Participant's First RLS Symptoms Using the 24-hour RLS Symptom Record at Day 14|The 24-Hour RLS Record is a diary in which participants report the presence and severity of RLS symptoms (none, mild, moderate, or severe) for a 24-hour period, in 30-min increments beginning at 8AM on the day prior to the visit. For Arms 2 and 3, upper limits of the confidence intervals are not available, as they are beyond the 24-hour time frame.|Day 14|Modified Intent-to-Treat (MITT) Population. Participants in the||participants||95% Confidence Interval|Median
840760|NCT01332318|Secondary|Number of Participants Who Responded to Treatment Based on Scores on the Participant-Rated CGI-I at Day 14|"The participant-rated CGI-I is a self-rated assessment designed to allow participants to rate the change of their disease severity over time based on a seven-point scale, with a score of 1 being very much improved, and a score of 7 being very much worse. Response was defined as a rating of very much improved or much improved (score of 1 or 2 on the scale)."|Day 14|"Modified Intent-to-Treat (MITT) Population. Participants in the GEn placebo and DPH placebo and the GEn placebo and DPH 50 mg on Day 16 arms have been combined into the GEn placebo and DPH group."||participants|||Number
840762|NCT01332318|Secondary|Number of Participants Who Responded to Treatment Based on Scores on the Investigator-Rated CGI-I at Day 14|"The investigator-rated CGI-I is a clinician-rated assessment designed to allow clinicians to rate the change of their participant's disease severity over time based on a seven-point scale, with a score of 1 being very much improved, and a score of 7 being very much worse compared to baseline. For this endpoint, response was defined as a rating of very much improved or much improved (score of 1 or 2 on the scale) compared to baseline."|Day 14|"Modified Intent-to-Treat (MITT) Population. Participants in the GEn placebo and DPH placebo and the GEn placebo and DPH 50 mg on Day 16 arms have been combined into the GEn placebo and DPH group."||participants|||Number
840763|NCT01332318|Secondary|Number of Participants in Each Category of the Investigator-Rated Clinician Global Impression of Improvement (CGI-I) Scale at Day 14|The CGI scale is a widely used tool designed to allow clinicians to rate the severity of illness and the change of the disease severity over time based on a seven-point rating scale, with a score of 1 being “very much improved” and a score of 7 being “very much worse” compared to baseline.|Day 14|"Modified Intent-to-Treat (MITT) Population. Participants in the GEn placebo and DPH placebo and the GEn placebo and DPH 50 mg on Day 16 arms have been combined into the GEn placebo and DPH group."||participants|||Number
840764|NCT01332318|Secondary|Mean Change From Baseline (Day -1) at Day 14 in the International Restless Legs Syndrome (IRLS) Rating Scale Total Score|The IRLS Rating scale is a measure of RLS disease severity and reflects the participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. Items are included that assess the impact of symptoms on participants’ mood, daily life, and activities. The total score ranges from 0-40 points, with 40 being the most severe. The scale assesses symptoms over the week prior to measurement.|Baseline (Day -1) and Day 14|"Modified Intent-to-Treat (MITT) Population. Participants in the GEn placebo and DPH placebo and the GEn placebo and DPH 50 mg on Day 16 arms have been combined into the GEn placebo and DPH group."||scores on a scale||Standard Deviation|Mean
840765|NCT01332318|Secondary|Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) on the Brief Assessment of Cognition (BAC) Scaled Tower of London (TOL) Score|Participants (par.) were asked to look at 2 pictures simultaneously; each picture showed 3 different colored balls arranged on 3 pegs. Par. were to estimate the number of times the balls in 1 picture would have to be moved to make the arrangement of balls identical to that of the second picture. Par. were allowed 20 seconds to respond to each pair of pictures. The number of correct items was the TOL Score (range: 0-22). The TOL scaled test score was calculated as indicated for the Verbal Memory Test. The scaled test score range is -7.53 to 2.76; higher scaled scores indicate better cognition.|Baseline (Days -1and 1) and Days 14, 15, and 16|Modified Intent-to-Treat (MITT) Population. The number of participants assessed at each study day varies due to incomplete/missing data.||scores on a scale||Standard Deviation|Mean
840766|NCT01332318|Secondary|Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) on the Brief Assessment of Cognition (BAC) Scaled Symbol Coding Test Score|Participants were given a list of numbers (numerals 1-9) that were each associated with a unique symbol. Participants decoded a list of 110 symbols as quickly as possible in 90 seconds. The total number of symbols correctly decoded was the Symbol Coding Score (range: 0-110). The Symbol Coding scaled test score was calculated as indicated for the Verbal Memory Test. Change from baseline was calculated as the Day composite score minus the Baseline composite score. The scaled test score range is -7 to 10.08, with higher scaled scores indicating better cognition.|Baseline (Days -1and 1) and Days 14, 15, and 16|Modified Intent-to-Treat (MITT) Population. The number of participants assessed at each study day varies due to incomplete/missing data.||scores on a scale||Standard Deviation|Mean
840767|NCT01332318|Secondary|Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) on the Brief Assessment of Cognition (BAC) Scaled Verbal Fluency Test Score|Verbal Fluency included one semantic fluency and two letter fluency tasks. Participants were given 60 seconds to name as many words as possible within a given semantic category (supermarket items), and in two separate trials, participants were given 60 seconds to generate as many words as possible that began with a given letter. The total number of words from all of the 3 trials was the Verbal Fluency score (range: 0-150). The scaled test score was calculated as indicated for the Verbal Memory Test. The scaled test score range is -5 to 10.83; higher scaled scores indicate better cognition.|Baseline (Days -1 and 1) and Days 14, 15, and 16|Modified Intent-to-Treat (MITT) Population. The number of participants assessed at each study day varies due to incomplete/missing data.||scores on a scale||Standard Deviation|Mean
840768|NCT01332318|Secondary|Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) on the Brief Assessment of Cognition (BAC) Scaled Token Motor Task Test Score|Participants were given 100 plastic tokens and asked to place them in a container, 2 at a time, as quickly as possible for 60 seconds. The number of tokens correctly placed in the container was the Token Motor Task score (range: 0-100). The BAC was conducted prior to each simulated driving test. The Token Motor Task scaled test score was calculated as indicated for the Verbal Memory Test. Change from baseline was calculated as the Day composite score minus the Baseline composite score. The scaled test score range is -6.95 to 3.35, with higher scaled scores indicating better cognition.|Baseline (Days -1and 1) and Days 14, 15, and 16|Modified Intent-to-Treat (MITT) Population. The number of participants assessed at each study day varies due to incomplete/missing data.||scores on a scale||Standard Deviation|Mean
840769|NCT01332318|Secondary|Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) on the Brief Assessment of Cognition (BAC) Scaled Digit Sequencing Score (DSS)|Participants (par.) were presented with sets of numbers of increasing length and asked to tell the experimenter the numbers in order from lowest to highest. The task has 7 levels; the first level had 2 digits in the set (e.g., 5, 2); the second level had 3 digits in the set, etc. The number of times the par. correctly arranged the numbers was recorded as the score for each level. The DSS is the sum of the 7 level scores (range: 0-28). The scaled test score was calculated as indicated for the Verbal Memory Test and ranges from -6.68 to 2.73; higher scaled scores indicate better cognition.|Baseline (Days -1and 1) and Days 14, 15, and 16|Modified Intent-to-Treat (MITT) Population. The number of participants assessed at each study day varies due to incomplete/missing data.||scores on a scale||Standard Deviation|Mean
840770|NCT01332318|Secondary|Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) on the Brief Assessment of Cognition (BAC) Scaled Verbal Memory Test Score|Participants were presented with 15 words and asked to recall as many as possible; the procedure was repeated 5 times. The total number of words recalled correctly across the 5 administrations of the list was the participant’s Verbal Memory Recall score (range: 0-75). The scaled test score was calculated as ((BAC component raw test score - healthy control sample test mean)/healthy control sample test standard deviation); a healthy control sample was matched to the participant's sex and age category. The scaled test score range is -7.37 to 4.86; higher scaled scores indicate better cognition.|Baseline (Days -1and 1) and Days 14, 15, and 16|Modified Intent-to-Treat (MITT) Population. The number of participants assessed at each study day varies due to incomplete/missing data.||scores on a scale||Standard Deviation|Mean
840771|NCT01332318|Secondary|Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) on the Brief Assessment of Cognition (BAC) Composite Score|The BAC was designed as a comprehensive measure of cognitive function, including 6 individual tests: Verbal Memory Recall, Digit Sequencing, Token Motor Task, Verbal Fluency, Symbol Coding, and Tower of London. The composite/total BAC score is calculated by scoring each individual test, comparing each score to a healthy control sample (matched for sex and age category) to create z-scores, summing the z-scores, and rescaling the sum. The composite score range is -2127.8 to 1878.8, with higher scores indicating better cognition.|Baseline (Days -1 and 1) and Days 14, 15, and 16|Modified Intent-to-Treat (MITT) Population. The number of participants assessed at each study day varies due to incomplete/missing data.||scores on a scale||Standard Deviation|Mean
840772|NCT01332318|Secondary|Change From Baseline (Day -1) to Day 14 (Evening) in the Epworth Sleepiness Scale (ESS) Total Score|"The Epworth Sleepiness Scale (ESS) is a questionnaire designed to evaluate daytime sleepiness. Participants were asked to rate how likely they were to doze or fall asleep during 8 activities on a scale of 0 (would never do) to 3 (high chance of dozing). The total score ranges from 0-24, with a score greater than 10 representing excessive daytime sleepiness (an increased chance of dozing). Change from baseline was calculated as the Day 14 total score minus the Baseline total score."|Baseline (Day -1) and Day 14|Modified Intent-to-Treat (MITT) Population||scores on a scale||Standard Deviation|Mean
840773|NCT01332318|Secondary|Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) in the Alertness Visual Analog Scale (VAS) Score|"Alertness VAS was completed immediately before and after each simulated driving assessment. Participants indicated their alertness by marking a vertical line on a horizontal scale anchored by responses extremely sleepy and extremely alert. VAS score was determined by measuring the distance in millimeters (mm) from the left hand end of the line to the point the participant marked. Scores ranged from 0-100 mm, with higher scores indicating more alertness and lower scores indicating more sleepiness. Change score was calculated as the Day 14, 15, or 16 VAS score minus the Baseline VAS score."|Baseline (Days -1 and 1) and Days 14, 15, and 16|Modified Intent-to-Treat (MITT) Population. Varying numbers of participants did not complete either the pre- or post-drive VAS at either Baseline or the day of assessment; as such, the number of participants analyzed varies by day.||millimeters||Standard Deviation|Mean
840774|NCT01332318|Secondary|Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) in Brake Reaction Time|Brake reaction time was assessed as the time it took for each participant to move their foot off the accelerator and onto the brake pedal after the appearance of a stop sign on the simulation screen. Change from baseline was calculated as the Day 14, 15, or 16 mean reaction time minus the Baseline (Days -1 and 1) mean reaction time.|Baseline (Days -1 and 1) and Days 14, 15, and 16|Modified Intent-to-Treat (MITT) Population. The number of participants assessed at each study day varies due to incomplete/missing data.||seconds||Standard Deviation|Mean
840775|NCT01332318|Secondary|Number of Participants With the Indicated Number of Simulated Crashes on Days 14 (Evening), 15 (Morning After Dose), and 16 (Tmax)|A simulated crash was defined as a collision with an oncoming car or obstacle (e.g., tree) or when the distance to the center line was greater than 18 feet on either side of the road.|Days 14, 15, and 16|Modified Intent-to-Treat (MITT) Population. The number of participants assessed at each study day varies due to incomplete/missing data.||participants|||Number
840776|NCT01332318|Secondary|Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) in Overall Average Speed|Participants were instructed to maintain a speed of 55 miles per hour during the driving assessment. Change from baseline in overall average speed was calculated as the Day 14 (in the evening), 15 (in the morning), or 16 (at Tmax of GEn and DPH) mean speed over the 1-hour drive minus the Baseline (Days -1 and 1) mean speed over the 1-hour drive.|Baseline (Days -1 and 1) and Days 14, 15, and 16|Modified Intent-to-Treat (MITT) Population. The number of participants assessed at each study day varies due to incomplete/missing data.||miles per hour||Standard Deviation|Mean
840777|NCT01332318|Secondary|Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) in Overall Speed Variability|Speed variability was defined as the standard deviation of the speed (measured in miles per hour). Participants were instructed to maintain a speed of 55 miles per hour during the test drive. Change from baseline in overall speed variability was calculated as the Day 14 (in the evening), 15 (in the morning), or 16 (at Tmax of GEn and DPH) mean speed variability over the 1-hour drive minus the Baseline (Days -1 and 1) mean speed variability over the 1-hour drive.|Baseline (Day -1) and Days 14 and 16; baseline (Day 1) and Day 15|Modified Intent-to-Treat (MITT) Population. The number of participants assessed at each study day varies due to incomplete/missing data.||miles per hour||Standard Deviation|Mean
840778|NCT01332318|Secondary|Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) in Overall Average Lane Position|Lane position was measured from the center line of the 26 foot wide 2-lane paved road to the center of the vehicle. Change from baseline in overall average lane position was calculated as the Day 14 (in the evening), 15 (in the morning after GEn dosed at 5 PM), or 16 (assessment at Tmax of GEn and DPH) mean lane position over the 1-hour drive minus the Baseline (Days -1 and 1) mean lane position over the 1-hour drive.|Baseline (Days -1 and 1) and Days 14, 15, and 16|Modified Intent-to-Treat (MITT) Population. The number of participants assessed at each study day varies due to incomplete/missing data.||feet||Standard Deviation|Mean
840779|NCT01332318|Secondary|Change From Baseline (Day -1) to Day 14 (Evening) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) in Overall Lane Position Variability (LPV)|Lane position variability (LPV) was defined as the standard deviation of lane position, and was measured from the center line of the 26 foot wide 2-lane paved road to the center of the vehicle. Change from baseline in overall LPV was calculated as the Day 14 (in the evening) or Day 15 (in the morning after GEn dosed at 5 PM) mean LPV over the 1-hour drive minus the Baseline (Day -1 or Day 1) mean LPV over the 1-hour drive.|Baseline (Days -1 and 1) and Days 14 and 15|Modified Intent-to-Treat (MITT) Population. The number of participants assessed at each study day varies due to incomplete/missing data.||feet||Standard Deviation|Mean
840780|NCT01332318|Primary|Change From Baseline (Day -1) in Overall Lane Position Variability (LPV) on Day 16 (Tmax)|Lane position variability (LPV) was defined as the standard deviation of lane position, and was measured from the center line of the 26 foot wide 2-lane paved road to the center of the vehicle. Change from baseline in overall LPV was calculated as the Day 16 mean LPV over the 1-hour drive minus the Baseline mean LPV over the 1-hour drive. The Day 16 measurement is at the time of maximum concentration (Tmax) for both GEn and DPH.|Baseline (Day -1) and Day 16|Modified Intent-to-Treat (MITT) Population: all participants in the Safety Population who completed at least one Baseline and one End of Study (Days 14-16) simulated driving assessment. The number of participants assessed at each study day varies due to incomplete/missing data.||feet||Standard Error|Least Squares Mean
840781|NCT01332357|Primary|Number of Participants With an Asthma-related Event Occurring Between 1 and 6 Months Following the Index Event|A subsequent asthma-related inpatient (IP) visit or emergency department (ED) visit were defined as visits within 6 months of the index event. The index event was defined as an asthma-related hospitalization or ED visit occuring between 2004 and 2008.|Data were collected during a 4-year period from January 1, 2004 to December 31, 2008.|Adult and pediatric participants with persistent asthma were identified from commercially-insured and Medicaid health plan members with both medical and pharmacy benefits who had data in one of two healthcare claims databases.||participants|||Number
840782|NCT01332435|Secondary|BPH-related Pharmacy Costs|Pharmacy costs related to BPH were defined by claims costs associated with a ICD-9CM diagnosis code for BPH (222.2, 600.xx).|Day 1 of a 1-day study|Enrolled Population||United States dollars||Standard Deviation|Mean
840783|NCT01332435|Secondary|BPH-related Medical Costs|Medical costs related to BPH were defined by claims costs associated with a ICD-9CM diagnosis code for BPH (222.2, 600.xx).|Day 1 of a 1-day study|Enrolled Population||United States dollars||Standard Deviation|Mean
840784|NCT01332435|Secondary|Total BPH-related Costs|All costs related to BPH were defined by claims costs associated with a ICD-9CM diagnosis code for BPH (222.2, 600.xx).|Day 1 of a 1-day study|Enrolled Population||United States dollars||Standard Deviation|Mean
840785|NCT01332435|Primary|Number of Participants Who Needed Prostate-Related Surgery|Prostate-related surgery was identified by relevant CPT procedure codes and ICD-9CM diagnosis codes.|Day 1 of a 1-day study|Enrolled Population||participants|||Number
840786|NCT01332435|Primary|Number of Participants With Acute Urinary Retention|Acute urinary retention was identified by relevant CPT procedure codes and ICD-9CM diagnosis codes.|Day 1 of a 1-day study|Enrolled Population||participants|||Number
840787|NCT01332435|Primary|Number of Participants With Clinical Progression|Clinical progression was identified as the occurrence of acute urinary retention and/or surgery as identified by relevant Common Procedure Terminology (CPT) procedure codes and International Classification of Diseases (ICD)-9CM diagnosis codes.|Day 1 of a 1-day study|Enrolled Population: Men aged >=50 years old between 7/1/2000 and 12/31/2006 with a diagnosis of benign prostatic hyperplasia and who were treated with an AB and concomitant 5-ARI therapy within 6 months of starting AB therapy||participants|||Number
840788|NCT01332461|Secondary|Mean Monthly COPD-related Costs Per Participant|Cost categories included medical, pharmacy, and total calculated as the sum of medical and pharmacy. Costs were computed during a variable follow-up period and were standardized on a per-month basis. COPD-related medical costs were computed using claims with a primary diagnosis of COPD, and COPD-related pharmacy costs were computed using the paid amounts of pharmacy claims for prescription medication used for COPD.|Maximum of 1 year after index date (Jan 1, 2004 through May 30, 2008)|Managed care enrollees with at least 1 inpatient hospitalization (IP) with primary or secondary diagnosis of COPD (International Classification of Disease (ICD) code 491.xx, 492.xx, and 496.xx) or at least one ER visit with primary diagnosis of COPD during the study period with maintenance medication within 60 days post-discharge||United States (US) dollars||Standard Deviation|Mean
840789|NCT01332461|Secondary|Number of Participants Having a COPD-related Event Related to Chronic Obstructive Pulmonary Disease (COPD) Represented Per 100 Person-years|The number of participants having a COPD-related event was computed during the follow-up and was standardized by dividing by the total days of follow-up in each cohort since patients had different lengths of follow-up. Four types of COPD events were defined: COPD-related hospitalization, emergency room (ER) visit, physician visit with a prescription (Rx) for oral corticosteroid or antibiotic within 3 days of the visit, or combined occurrence of any of the aforementioned three types.|Maximum of 1 year after index date (Jan 1, 2004 through May 30, 2008)|Managed care enrollees with at least 1 inpatient hospitalization (IP) with primary or secondary diagnosis of COPD (International Classification of Disease (ICD) code 491.xx, 492.xx, and 496.xx) or at least one ER visit with primary diagnosis of COPD during the study period with maintenance medication within 60 days post-discharge||participants per 100 person-years|||Number
840790|NCT01332461|Primary|Number of Participants Having a Hospitalization or Emergency Room (ER) Visit Related to Chronic Obstructive Pulmonary Disease (COPD) Represented Per 100 Person-years|The number of participants (par.) with a COPD-related hospitalization/ ER visit was computed during follow-up (FU) and was standardized by dividing by the total days of FU in each cohort since par. had different lengths of FU. The number of par. per 100 person-years was computed as: numerator = total number of par. with a COPD-related hospitalization/ER visit; denominator = sum of the time of FU in years across all par./100. The index date is defined as the date of discharge from a hospitalization/ER visit for COPD that had a maintenance medication dispensed within 60 days post-discharge.|Maximum of 1 year after index date (Jan 1, 2004 through May 30, 2008)|Managed care enrollees with at least 1 inpatient hospitalization (IP) with primary or secondary diagnosis of COPD (International Classification of Disease (ICD) code 491.xx, 492.xx, and 496.xx) or at least one ER visit with primary diagnosis of COPD during the study period with maintenance medication within 60 days post-discharge||participants per 100 person-years|||Number
840791|NCT01332487|Secondary|Number of Participants With the Indicated Time Between Acute Urinary Retention and Subsequent Surgery||6 months|Male participants age 50 years and older with a diagnosis of benign prostatic hyperplasia (BPH) or enlarged prostate (EP). Only those participants who were treated with surgery within 182 days of the first prescription of 5ARI were analyzed.||participants|||Number
840792|NCT01332487|Primary|Number of Participants Who Experienced Progression of Disease|The number of participants in each study group with a treatment code for acute urinary retention, surgery, or emergency surgery (defined as surgery within 30 days following a diagnosis of acute urinary retention) was measured.|Up to 5 months|Male participants age 50 years and older with a diagnosis of benign prostatic hyperplasia (BPH) or enlarged prostate (EP)||participants|||Number
840793|NCT01332500|Primary|Mean Total Cost (Health Plan Plus Participant Copay Costs) Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-switch Analysis|Mean Total Cost was defined as the pharmacy cost plus the participant copay. Pharmacy costs were computed corresponding to the use of triptans, non-steroidal anti-inflammatory drugs, opioids, and other migraine therapy tablets (ergots and others). .Pharmacy cost plus participant copay was calculated as the mean of the total costs (pharmacy cost plus participant copay) of the five drug categories.|6-months from the index date (from January 1, 2009 to May 31, 2009; index date was defined as the first switch date to oral triptan/sumatriptan-naproxen sodium prescription)|The SourceLx dataset from the family of Wolters Kluwer databases was used for this study. The database contains 30% of prescription claims filled in the United States, corresponding to approximately 160 million lives.||United States dollars||Standard Deviation|Mean
840794|NCT01332500|Primary|Mean Health Plan Cost Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-switch Analysis|Health Pan Cost was defined as the pharmacy costs. Pharmacy costs were computed corresponding to the use of triptans, non-steroidal anti-inflammatory drugs, opioids, and other migraine therapy tablets (ergots and others). Pharmacy costs were calculated as the mean of the total costs of the five drug categories.|6-months from the index date (from January 1, 2009 to May 31, 2009; index date was defined as the first switch date to oral triptan/sumatriptan-naproxen sodium prescription)|The SourceLx dataset from the family of Wolters Kluwer databases was used for this study. The database contains 30% of prescription claims filled in the United States, corresponding to approximately 160 million lives.||United States dollars||Standard Deviation|Mean
840795|NCT01332500|Primary|Mean Number of Triptan Tablets Per Participant in 6-month Follow-up Period: Treatment-switch Analysis|"The mean number of tablets per participant was computed using prescription fills dispensed in the 6-month follow-up period. Other represents APAP/isometheptene/dichlorphenazone and APAP/isometheptene/caffeine, for example. The number of tablets dispensed was obtained from the quantity dispensed field in the claims data. Triptan tablets were classified as index and non-index medication (if a different oral triptan was filled from that of the index medication); only oral triptans were considered (i.e., excluded injectable triptans)."|6-months from the index date (from January 1, 2009 to May 31, 2009; index date was defined as the first switch date to oral triptan/sumatriptan-naproxen sodium prescription)|The SourceLx dataset from the family of Wolters Kluwer databases was used for this study. The database contains 30% of prescription claims filled in the United States, corresponding to approximately 160 million lives.||tablets per participant||Standard Deviation|Mean
840796|NCT01332500|Primary|Mean Total Cost (Health Plan Plus Participant Copay Costs) Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-naïve Analysis|Mean Total Cost was defined as the pharmacy cost plus the participant copay. Pharmacy costs were computed corresponding to the use of triptans, non-steroidal anti-inflammatory drugs, opioids, and other migraine therapy tablets (ergots and others). Pharmacy cost plus participant copay was calculated as the mean of the total costs (pharmacy cost plus participant copay) of the five drug categories.|6-months from the index date (from January 1, 2009 to May 31, 2009; the index date was defined as the first date of oral triptan/sumatriptan-naproxen sodium prescription)|The SourceLx dataset from the family of Wolters Kluwer databases was used for this study. The database contains 30% of prescription claims filled in the United States, corresponding to approximately 160 million lives.||United States dollars||Standard Deviation|Mean
840797|NCT01332500|Primary|Mean Health Plan Cost Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-naïve Analysis|Health plan cost was defined as the pharmacy costs. Pharmacy costs were computed corresponding to the use of triptans, non-steroidal anti-inflammatory drugs, opioids, and other migraine therapy tablets (ergots and others). Pharmacy costs were calculated as the mean of the total costs of the five drug categories.|6-months from the index date (from January 1, 2009 to May 31, 2009; the index date was defined as the first date of oral triptan/sumatriptan-naproxen sodium prescription)|The SourceLx dataset from the family of Wolters Kluwer databases was used for this study. The database contains 30% of prescription claims filled in the United States, corresponding to approximately 160 million lives.||United States dollars||Standard Deviation|Mean
840798|NCT01332500|Primary|Mean Number of Triptan Tablets Per Participant in 6-month Follow-up Period: Treatment-naïve Analysis|"The mean number of tablets per participant was computed using prescription fills dispensed in the 6-month follow-up period. Other represents acetaminophen (APAP)/isometheptene/dichlorphenazone and APAP/isometheptene/caffeine, for example. The number of tablets dispensed was obtained from the quantity dispensed field in the claims data. Triptan tablets were classified as index and non-index medication (if a different oral triptan was filled from that of the index medication); only oral triptans were considered (i.e., excluded injectable triptans)."|6-months from the index date (from January 1, 2009 to May 31, 2009; the index date was defined as the first date of oral triptan/sumatriptan-naproxen sodium prescription)|The SourceLx dataset from the family of Wolters Kluwer databases was used for this study. The database contains 30% of prescription claims filled in the United States, corresponding to approximately 160 million lives.||tablets per participant||Standard Deviation|Mean
840799|NCT01332578|Secondary|Time to Onset and Completion of Disintegration of Reference Tablets|Qualitative onset and completion of tablet disintegration was determined using Gamma scintigraphy images and WebLink image analysis program.|Baseline to 10 hours post dose|Period Level MITT population: all randomized participants with any post baseline pharmacokinetic measurement or scintigraphic measurement, and had evaluable data in one of the two study periods. Tablet Disintegration endpoints were only measured in the first period for each participant.||minutes||Standard Deviation|Mean
840800|NCT01332578|Secondary|Time to Completion of Gastric Emptying|Time to completion of gastric emptying of hot drink remedy and standard paracetamol tablets was assessed using Gamma Scintigraphy images and WebLink image analysis program. Completion of gastric emptying was confirmed by two consecutive images with negligible gastric activity.|Baseline to 10 hours|Period Level MITT population: all randomized participants with any post baseline pharmacokinetic measurement or scintigraphic measurement, and had evaluable data in one of the two study periods. Gastric emptying endpoints were only measured in the first period for each participant.||minutes||Standard Error|Least Squares Mean
840801|NCT01332578|Secondary|Time to Onset of Gastric Emptying|The individual anterior and posterior images were assessed using Gamma Scintigraphy images and WebLink Image Analysis program to determine the time to onset of gastric emptying of hot drink remedy and standard paracetamol tablets.|Baseline to 10 hours|Period Level MITT population: all randomized participants with any post baseline pharmacokinetic measurement or scintigraphic measurement, and had evaluable data in one of the two study periods. Gastric emptying endpoints were only measured in the first period for each participant.||minutes||Standard Error|Least Squares Mean
840802|NCT01332578|Secondary|Time to Maximum Plasma Concentration (Tmax)|Time after administration when the maximum plasma concentration was reached.|Blood samples taken within 15-30 min prior to dosing and at 3, 5, 7, 9, 11, 15, 20, 30, 45, 90, 120 and 180 minutes post-dose|MITT population: all randomized participants with any post baseline pharmacokinetic measurement or scintigraphic measurement, and had evaluable data in at least one of the two study periods.||hours||Full Range|Median
840803|NCT01332578|Secondary|Maximum Plasma Concentration (Cmax)|Cmax was determined using plasma paracetamol concentration time profile.|Blood samples taken within 15-30 min prior to dosing and at 3, 5, 7, 9, 11, 15, 20, 30, 45, 90, 120 and 180 minutes post-dose|MITT population: all randomized participants with any post baseline pharmacokinetic measurement or scintigraphic measurement, and had evaluable data in at least one of the two study periods.||ng/mL||Standard Deviation|Mean
840804|NCT01332578|Secondary|AUC (0-60 Min)|AUC (0-60 min) was determined from paracetamol plasma concentration time profiles using trapezoidal method.|Blood samples taken within 15-30 min prior to dosing and at 3, 5, 7, 9, 11, 15, 20, 30, 45, 90, 120 and 180 minutes post-dose|MITT population: all randomized participants with any post baseline pharmacokinetic measurement or scintigraphic measurement, and had evaluable data in at least one of the two study periods.||ng*h/mL||Standard Deviation|Mean
840805|NCT01332578|Secondary|Area Under the Concentration/Time Curve From 0 to 30 Minutes (Min) (AUC 0-30 Min)|AUC (0-30 min) was determined from paracetamol plasma concentration time profiles using trapezoidal rule.|Blood samples taken within 15-30 min prior to dosing and at 3, 5, 7, 9, 11, 15, 20, 30, 45, 90, 120 and 180 minutes post-dose|MITT population: all randomized participants with any post baseline pharmacokinetic measurement or scintigraphic measurement, and had evaluable data in at least one of the two study periods.||nanograms (ng)*hours (h)/mL||Standard Deviation|Mean
840806|NCT01332578|Primary|Time to Reach Plasma Paracetamol Concentration of 0.25 μg/mL (Microgram Per Milliliter)|Time to reach plasma paracetamol concentration of 0.25 μg/mL was determined using plasma concentration time profiles.|Blood samples taken within 15-30 minutes prior to dosing and at 3, 5, 7, 9, 11, 15, 20, 30, 45, 90, 120 and 180 minutes post-dose|Modified Intent-To-Treat (MITT) population: all randomized participants with any post baseline pharmacokinetic measurement or scintigraphic measurement, and had evaluable data in at least one of the two study periods.||minutes||Full Range|Median
840807|NCT01332721|Secondary|Objective Response According to RECIST 1.1|The best response according to RECIST 1.1 for each patient with measurable disease and who received at least one dose of study drug will be listed by cohort and tumor type|1.5 years|||participants|||Number
840808|NCT01332721|Secondary|Immune Response to TRC105|HAMA and HACA titers will be measured at specified time-points.|1.5 years|||participants|||Number
840809|NCT01332721|Secondary|TRC105 Pharmacokinetic Concentrations|Plasma TRC105 concentrations will be measured at specified timepoints.|1.5 years||||||
840810|NCT01332721|Primary|Determine Maximum Tolerated Dose of TRC105 in Combination With Bevacizumab|Safety and dose limiting toxicity will be assessed by dose cohort.|1.5 years|||mg/kg|||Number
840811|NCT01332968|Secondary|Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Follow Up Phase|The EQ-5D is a quality of life questionnaire with five questions, each with three categories (no problem, moderate problem, severe problems) and a visual analogue scale (VAS) from 0 (worst possible health state) to 100 (best possible health state. Summary score ranges from 0 to 1. Higher scores indicate better outcomes. A positive change from baseline indicates an improvement. Maintenance/Observation is indicated as Maint/Obs in data categories. Completion includes completion visit and early termination visit.|Induction: Cycle 1 Day 1 (Baseline), Cycle 3 Day 1, End of Induction (up to 7 months); Maintenance: 2, 12 after Day 1 of last induction cycle, Follow-up: every year for up to data cut-off (up to 4 years and 7 months)|The FL ITT population, defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received.||units on a scale||Standard Deviation|Mean
840812|NCT01332968|Secondary|Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Maintenance/Observation Phase|The EQ-5D is a quality of life questionnaire with five questions, each with three categories (no problem, moderate problem, severe problems) and a visual analogue scale (VAS) from 0 (worst possible health state) to 100 (best possible health state. Summary score ranges from 0 to 1 Higher scores indicate better outcomes. A positive change from baseline indicates an improvement. Maintenance/Observation is indicated as Maint/Obs. Completion includes completion visit and early termination visit.|Induction: Cycle 1 Day 1 (Baseline), Cycle 3 Day 1, End of Induction (up to 7 months); Maintenance: 2, 12 months after Day 1 of last induction cycle, Follow-up: every year up to data cut-off (up to 4 years and 7 months)|The FL ITT population, defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received.||units on a scale||Standard Deviation|Mean
840910|NCT01338649|Secondary|Actigraphy Measures Including Total Sleep Time, Sleep Efficiency, Sleep Fragmentation Index, Frequency of Naps, and Mean Activity Level (a Measurement of Daytime Function) Will be Collected.|Actigraphy measures including total sleep time, sleep efficiency, sleep fragmentation index, frequency of naps, and mean activity levelwill be completed for 3 - 2 week intervals by the subjects at home. Actigraphy measures will be collected at weeks 2, 4 and 6.|6 weeks||||||
840813|NCT01332968|Secondary|Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Induction Phase|The EQ-5D is a quality of life questionnaire with five questions, each with three categories (no problem, moderate problem, severe problems) and a visual analogue scale (VAS) from 0 (worst possible health state) to 100 (best possible health state. Summary score ranges from 0 to 1. Higher scores indicate better outcomes. A positive change from baseline indicates an improvement. Completion (Compl) includes completion visit and early termination visit. Maintenance/Observation is indicated as Maint/Obs.|Induction: Cycle 1 Day 1 (Baseline), Cycle 3 Day 1, End of Induction (up to 7 months); Maintenance: 2, 12 months after Day 1 of last induction cycle, Follow-up: every year up to data cut-off (up to 4 years and 7 months)|The FL ITT population, defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received.||units on a scale||Standard Deviation|Mean
840814|NCT01332968|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Total Score (Follicular Population)|The FACT-Lym Total Score for the follicular lymphoma population was derived from the following 5 individual FACT-Lym questionnaire subscale scores: Physical Well-being (range: 0-28), Social/Family Well-being (range: 0-28), Emotional Well-being (range: 0-24),Functional Well-being (range: 0-28) and Lymphoma (range: 0-60). The FACT-Lym Total Score is the sum of all 5 individual subscales (range 0-168). Higher scores indicate better outcomes. A positive change from baseline indicates an improvement.|Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 4 years and 7 months)|The FL ITT population was defined as all randomized participants with follicular histology grouped according to their randomized treatment arm regardless of what treatments were actually received.||units on a scale||Standard Deviation|Mean
840815|NCT01332968|Secondary|Change From Baseline in FACT-Lym Individual Subscale Lymphoma Score (Follicular Population)|The FACT-Lym Individual Subscale Lymphoma Score for the follicular lymphoma population was derived from the Lymphoma subscale questionnaire (range: 0-60). Higher scores indicate better outcomes. A positive change from baseline indicates an improvement.|Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 4 years and 7 months)|The FL ITT population was defined as all randomized participants with follicular histology grouped according to their randomized treatment arm regardless of what treatments were actually received.||units on a scale||Standard Deviation|Mean
840816|NCT01332968|Secondary|Change From Baseline in FACT-Lym Total Outcome Index (TOI) Score (Follicular Lymphoma Population)|The FACT-Lym TOI Score for the follicular lymphoma population was derived from the following 3 individual FACT-Lym questionnaire subscale scores: Physical Well-being (range: 0-28), Functional Well-being (range: 0-28) and Lymphoma (range: 0-60). The FACT-Lym TOI Score is the sum of the 3 individual subscales (range 0-116). Higher scores indicate better outcomes. A positive change from baseline indicates an improvement.|Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 4 years and 7 months)|The FL ITT population was defined as all randomized participants with follicular histology grouped according to their randomized treatment arm regardless of what treatments were actually received.||units on a scale||Standard Deviation|Mean
840817|NCT01332968|Secondary|Change From Baseline in All Domains of FACT-G (Follicular Lymphoma Population)|FACT-G consists of the following 4 FACT-Lym sub-questionnaires: Physical Well-being (range: 0-28), Social/Family Well-being (range: 0-28), Emotional Well-being (range: 0-24) and Functional Well-being (range: 0-28). Higher scores indicate better outcomes. A positive change from baseline indicates improvement. Maint = Maintenance period.|Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 4 years and 7 months)|The FL ITT population was defined as all randomized participants with follicular histology grouped according to their randomized treatment arm regardless of what treatments were actually received.||units on a scale||Standard Deviation|Mean
840818|NCT01332968|Secondary|Percentage of Participants With Adverse Events|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|Baseline up to data cut-off (up to approximately 4 years and 7 months)|The safety analysis population included all participants who received any amount of any study drug and participants were analyzed according to the treatment received.||percentage of participants|||Number
840819|NCT01332968|Secondary|Time to Next Anti-Lymphoma Treatment (Overall Study Population)|Time to next anti-lymphoma treatment was defined as the time from the date of randomization to the start date of the next anti-lymphoma treatment or death from any cause. Reported is the percentage of participants with event.|Baseline up to data cut-off (up to approximately 4 years and 7 months)|The ITT population defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received.||percentage of participants with event|||Number
840820|NCT01332968|Secondary|Time to Next Anti-Lymphoma Treatment (Follicular Lymphoma Population)|Time to next anti-lymphoma treatment was defined as the time from the date of randomization to the start date of the next anti-lymphoma treatment or death from any cause. Reported is the percentage of participants with event.|Baseline up to data cut-off (up to approximately 4 years and 7 months|The FL ITT population, defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received.||percentage of participants with event|||Number
840835|NCT01332968|Secondary|Overall Response (Overall Study Population), Investigator-Assessed|Overall response in the overall study population was defined as percentage of participants with partial response (PR) or complete response (CR) determined on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without positron emission tomography (PET). CR was defined as disappearance of all target lesions; PR was defined as >=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by >/= 50%; Overall Response (OR) = CR + PR.|Baseline up to end of induction period (up to approximately 7 months)|The ITT population defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received.||percentage of participants with event|||Number
840821|NCT01332968|Secondary|Duration of Response (DOR) (Overall Study Population), Investigator-Assessed|DOR was defined as the time from first occurrence of a documented CR or PR to disease progression/relapse, or death from any cause for participants with a response of CR or PR any time prior to NALT based on RRCML. Tumor assessments were performed with CT/MRI. CR was defined as disappearance of all target lesions. PR was defined as >/=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by >/= 50%. Progression/relapse was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm.|From first occurrence of documented CR or PR to data cut-off (up to approximately 4 years and 7 months)|Participants with CR or PR within the ITT population were included in the analysis. The ITT population defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received.||percentage of participants with event|||Number
840822|NCT01332968|Secondary|Duration of Response (DOR) (Follicular Lymphoma Population), Investigator-Assessed|DOR was defined as the time from first occurrence of a documented CR or PR to disease progression/relapse, or death from any cause for participants with a response of CR or PR any time prior to NALT based on RRCML. Tumor assessments were performed with CT/MRI. CR was defined as disappearance of all target lesions. PR was defined as >/=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by >/= 50%. Progression/relapse was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm.|From first occurrence of documented CR or PR to data cut-off (up to approximately 4 years and 7 months|Participants with CR or PR within the FL ITT population were included in the analysis.The FL ITT population, defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received.||percentage of participants with event|||Number
840823|NCT01332968|Secondary|Disease-Free Survival (Overall Study Population)|Disease-free survival in the overall study population was defined as the time from the date of the first occurrence of a documented CR to the date of disease progression/ relapse, or death from any cause for the subgroup of participants with a response of CR at any time prior to NALT on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI. CR was defined as disappearance of all target lesions. Progression/relapse was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. Reported is the percentage of participants with event.|From first occurrence of documented CR to data cut-off (up to approximately 4 years and 7 months|Participants with CR within the ITT population were included in the analysis.The ITT population was defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received.||percentage of participants with event|||Number
840824|NCT01332968|Secondary|Disease-Free Survival (Follicular Lymphoma Population)|Disease-free survival in the follicular lymphoma population was defined as the time from the date of the first occurrence of a documented CR to the date of disease progression/ relapse, or death from any cause for the subgroup of participants with a response of CR at any time prior to NALT on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma (RRCML). Tumor assessments were performed with CT/MRI. CR was defined as disappearance of all target lesions. Progression/relapse was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. Reported is the percentage of participants with event.|From first occurrence of documented CR to data cut-off (up to approximately 4 years and 7 months)|Participants with CR within the FL ITT population were included in the analysis.The FL ITT population, defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received.||percentage of participants with event|||Number
840825|NCT01332968|Secondary|Event-Free Survival (Overall Study Population)|Event-free survival in the overall study population was defined as the time from the date of randomization to the date to disease progression/relapse, death from any cause, or initiation of a new anti-lymphoma treatment (NALT) on the basis of investigator assessment assessments with the use of Revised Response Criteria for Malignant Lymphoma. Disease progression/relapse was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. Tumor measurements were obtained by CT/MRI. Reported is the percentage of participants with event.|Baseline up to data cut-off (up to approximately 4 years and 7 months|The ITT population defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received.||percentage of participants with event|||Number
840876|NCT01332994|Secondary|Change From Baseline in Hemoglobin at Weeks 4, 8, 12, and 16|Blood samples for laboratory assessments, including hemoglobin level, were collected prior to each dose of study medication. The mean hemoglobin level was determined at Baseline and for assessment visits by averaging the observed hemoglobin level among all participants providing evaluable blood samples. Change from Baseline was calculated as [mean hemoglobin at the assessment visit minus mean hemoglobin at Baseline] and expressed in grams per liter (g/L).|Baseline and Weeks 4, 8, 12, and 16|Main ITT Population. Participants with evaluable data at the designated visit (number shown = n) were included.||g/L||Standard Deviation|Mean
840826|NCT01332968|Secondary|Event-Free Survival (Follicular Lymphoma Population)|Event-free survival in the follicular lymphoma population was defined as the time from the date of randomization to the date to disease progression/relapse, death from any cause, or initiation of a new anti-lymphoma treatment (NALT) on the basis of investigator assessment assessments with the use of Revised Response Criteria for Malignant Lymphoma. Disease progression/relapse was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. Tumor measurements were obtained by CT/MRI. Reported is the percentage of participants with an event.|Baseline up to data cut-off (up to approximately 4 years and 7 months)|The FL ITT population, defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received.||percentage of participants with event|||Number
840827|NCT01332968|Secondary|Overall Survival (Overall Study Population)|Overall survival in the overall study population was defined as the time from the date of randomization to the date of death from any cause. Reported is the percentage of participants with event.|Baseline up to data cut-off (up to approximately 4 years and 7 months|The ITT population defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received.||percentage of participants with event|||Number
840828|NCT01332968|Secondary|Overall Survival (Follicular Lymphoma Population)|Overall survival in the follicular lymphoma population was defined as the time from the date of randomization to the date of death from any cause. Reported is the percentage of participants with event.|Baseline up to data cut-off (up to approximately 4 years and 7 months|The FL ITT population, defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received.||percentage of participants with event|||Number
840829|NCT01332968|Secondary|Complete Response (Overall Study Population), IRC-Assessed|Percentage of participants with complete response in the overall study population was determined on the basis of IRC assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions.|Baseline up to end of induction period (up to approximately 7 months)]|The ITT population defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received.||percentage of participants with event|||Number
840830|NCT01332968|Secondary|Complete Response (Follicular Lymphoma Population), IRC-Assessed|Percentage of participants with complete response in the follicular lymphoma population was determined on the basis of IRC assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions.|Baseline up to end of induction period (up to approximately 7 months)|The FL ITT population, defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received.||percentage of participants with event|||Number
840831|NCT01332968|Secondary|Overall Response (Overall Study Population), IRC-Assessed|Overall response in the overall study population was defined as percentage of participants with PR or CR determined on the basis of IRC assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions; PR was defined as >=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by >/= 50%; Overall Response (OR) = CR + PR.|Baseline up to end of induction period (up to approximately 7 months)|The ITT population defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received.||percentage of participants with event|||Number
840832|NCT01332968|Secondary|Overall Response (Follicular Lymphoma Population), IRC-Assessed|Overall response in the follicular lymphoma population was defined as percentage of participants with PR or complete response CR determined on the basis of IRC assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions; PR was defined as >=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by >/= 50%. Overall Response (OR) = CR + PR.|Baseline up to end of induction period (up to approximately 7 months)|The FL ITT population, defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received.||percentage of participants with event|||Number
840833|NCT01332968|Secondary|Complete Response (Overall Study Population), Investigator-Assessed|Percentage of participants with complete response in the overall study population was determined on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions.|Baseline up to end of induction period (up to approximately 7 months)|The ITT population defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received.||percentage of participants with event|||Number
840834|NCT01332968|Secondary|Complete Response (Follicular Lymphoma Population), Investigator-Assessed|Percentage of participants with complete response in the follicular lymphoma population was determined on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions.|Baseline up to end of induction period (up to approximately 7 months)|The FL ITT population, defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received.||percentage of participants with event|||Number
840911|NCT01338649|Secondary|The Global PSQI Score and PDSS Score Will be Compared.|The global PSQI and PDSS scores will be taken and compared at screening, week 4 and week 6 visits.|6 weeks||||||
840836|NCT01332968|Secondary|Overall Response (Follicular Lymphoma Population), Investigator-Assessed|Overall response in the follicular lymphoma population was defined as percentage of participants with PR or complete response CR determined on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with and without PET. CR was defined as disappearance of all target lesions; PR was defined as >=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by >/= 50%. Overall Response (OR) = CR + PR.|Baseline up to end of induction period (up to approximately 7 months)|The FL ITT population, defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received.||percentage of participants with event|||Number
840837|NCT01332968|Secondary|Progression-Free Survival (Overall Study Population), Assessed by Independent Review Committee (IRC)|Progression-free survival in the overall study population was defined as the time from randomization until the first documented day of disease progression or death from any cause, whichever occurred first, on the basis of IRC assessments according to the Revised Response Criteria for Malignant Lymphoma. Progression was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. Tumor measurements were obtained by CT/MRI.|Baseline up to data cut-off (up to approximately 4 years and 7 months)|The ITT population defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received.||percentage of participants with event|||Number
840838|NCT01332968|Secondary|Progression-Free Survival (Follicular Lymphoma Population), IRC-Assessed|Progression-free survival in the participants with follicular lymphoma was defined as the time from randomization until the first documented day of disease progression or death from any cause, whichever occurred first, on the basis of IRC assessments according to the Revised Response Criteria for Malignant Lymphoma. Progression was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. Tumor measurements were obtained by CT/MRI. In the first 170 patients with follicular lymphoma, an FDG-PET was mandatory where a PET scanner was available.|Baseline up to data cut-off (up to approximately 4 years and 7 months)|The FL ITT population, defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received.||percentage of participants with event|||Number
840839|NCT01332968|Secondary|Progression-Free Survival in the Overall Study Population, Investigator-Assessed|Progression-free survival in the overall study population was defined as the time from randomization until the first documented day of disease progression or death from any cause, whichever occurred first, on the basis of investigator assessments according to the Revised Response Criteria for Malignant Lymphoma. Progression was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. Tumor measurements were obtained by CT/MRI.|Baseline up to data cut-off (up to approximately 4 years and 7 months)|The ITT population defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received.||percentage of participants with event|||Number
840840|NCT01332968|Primary|Progression-Free Survival in the Follicular Lymphoma Population, Investigator-Assessed|Progression-free survival in participants with follicular lymphoma was defined as the time from randomization until the first documented day of disease progression or death from any cause, whichever occurred first, on the basis of investigator assessments according to the Revised Response Criteria for Malignant Lymphoma. Progression was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. Tumor measurements were obtained by computed tomography (CT) or magnetic resonance imaging (MRI).|Baseline up to data cut-off (up to approximately 4 years and 7 months)|The intent-to-treat follicular lymphoma population (FL ITT), defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received.||percentage of participants with event|||Number
840841|NCT01332981|Secondary|Prognostic Factors For Time to Progression|Prognostic factors for TTP were searched by using Cox regression model. First, all parameters were analysed in univariate models, and the hypothesis of proportional risks was tested. Significant parameters at 15% level were retained for multivariate model. For multivariate analyses, 2 models were built for prognostic factor of TTP. In Model 1, stepwise selection method was used on all parameters that were significant in the univariate analyses, whatever the significance level of the associations between parameters. In Model 2, stepwise selection was used on the significant parameters that were not correlated. The significance level for entry was 10% and the significance level for exit was 5%. Six parameters remained in the Model 1 to search for prognostic factors of TTP. Once the correlated variables were removed, there were only 3 variables left in Model 2: the age was not kept by the stepwise selection. Results below are for Model 1 and similar results were obtained for Model 2|Up to 7 years|Participants with HER2+ metastatic breast cancer included in HERMINE study and treated with trastuzumab as first line therapy.||Hazard Ratio||95% Confidence Interval|Number
840912|NCT01338649|Primary|Change in the Epworth Sleepiness Scale (ESS) Scores Comparing the Bright Light Exposure With Dim-red Light Exposure.|ESS score range is 0-24; lower ESS scores indicate less daytime sleepiness; higher ESS scores indicate more severe sleepiness ESS will be taken and compared at screening and week 4 visits between the bright light exposure and dim-red light exposure groups.|baseline and 4 weeks|||score||Standard Deviation|Mean
840842|NCT01332981|Secondary|Prognostic Factors for Overall Survival|Search for prognostic factors for OS was performed using Cox regression model. First, all parameters were analyzed in univariate models, and the hypothesis of proportional risks was tested. Significant parameters at 15%-level were retained for the multivariate model. For the multivariate analysis, two models were built for prognostic factors for OS. In the first one (Model 1), a stepwise selection method was used on all parameters that were significant in the univariate analyses, whatever the significance level of the associations between parameters. In the second one (Model 2), a stepwise selection was used on the significant parameters that were not correlated. The significance level for entry was 10% and the significance level for removal was 5%. The variables n°5 and n°6 were found to be significantly associated, thus only the variable n°6 was tested in the Model 2. This variable was not retained by the stepwise selection in the Model 1, contrary to the variable n°5.|Up to 7 years|Participants with HER2+ metastatic breast cancer included in HERMINE study and treated with trastuzumab as first line therapy.||Hazard Ratio||95% Confidence Interval|Number
840843|NCT01332981|Secondary|Median Treatment Duration and the Duration of Exposure to Trastuzumab|Treatment duration was defined as the time between the first and the last infusion of trastuzumab. Exposure duration was defined only for the participants who continued trastuzumab after HERMINE study, as the sum of treatment duration as part of HERMINE study and of the treatment durations as part of post-HERMINE study taking into account temporary treatment discontinuations. For analyses of treatment and exposure duration , dates of infusion of trastuzumab were missing for 18 participants, so treatment and exposure durations were calculated for only 202 participants.|Up to 7 years|Participants with HER2+ metastatic breast cancer included in HERMINE study and treated with trastuzumab as first line therapy.||Years||Full Range|Median
840844|NCT01332981|Secondary|Median Time to Progression|The Time to Progression (TTP) was defined as the time between the treatment start date (date of the first trastuzumab infusion) and the date of the first disease progression or disease-related death. Participants who had not progressed at the end of the post-HERMINE study were censored at the last date they were known to be alive. If the cause of death was unknown, the death was considered for this analysis as due to the disease. All participants who did not progress, the death was considered to be due to the disease.|Up to 7 years|Participants with HER2+ metastatic breast cancer included in HERMINE study and treated with trastuzumab as first line therapy.||Years||95% Confidence Interval|Median
840845|NCT01332981|Secondary|Median Time to Progression-Free Survival|The Progression-Free Survival (PFS) was defined as the time between the treatment start date (date of the first trastuzumab infusion) and the date of the first disease progression or disease-related death. Participants who had not progressed at the end of the post-HERMINE study were censored at the last date they were known to be alive. Progression-Free Survival was estimated by using Kaplan-Meier method.|Up to 7 years|Participants with HER2+ metastatic breast cancer included in HERMINE study and treated with trastuzumab as first line therapy.||Years||95% Confidence Interval|Median
840846|NCT01332981|Primary|Median Overall Survival|The time between the first infusion of trastuzumab and the date of death from any cause. Participants who were still alive at the end of the post-HERMINE study or lost to follow-up were censored at the last date they were known to be alive.|Up to 7 years|Participants with HER2+ metastatic breast cancer included in HERMINE study and treated with trastuzumab as first line therapy.||Years||95% Confidence Interval|Median
840847|NCT01332994|Secondary|Change From Week 16 to 32 in Quality of Life as Assessed Using FACIT Among Nonresponding Participants Treated With Rituximab|The FACIT-F evaluates quality of life using 5 categories: PWB, SWB, EWB, FWB, and FS. Participants answer each item on a 5-point scale from 0 to 4. The total score is the sum of individual responses across all 5 categories and may range from 0 to 160. The FACIT-G (range 0 to 108) is the sum of scores for PWB, SWB, EWB, and FWB; the FACIT-F TOI (range 0 to 108) is the sum of scores for PWB, FWB, and FS; and the FACIT-F fatigue (range 0 to 52) is the sum of scores for the FS only. For derivations of the FACIT-F reported here, higher scores indicate better quality of life. The mean score at each timepoint was determined by averaging scores among all participants, and the change in score was calculated as [mean score at Week 32 minus mean score at Week 16].|Weeks 16 and 32|ITT3 Population. Participants with evaluable data at the designated visit were included.||units on a scale||Standard Deviation|Mean
840848|NCT01332994|Secondary|Change From Week 16 to 32 in Quality of Life as Assessed Using FACIT Among Participants Treated With 8 Courses of Tocilizumab|The FACIT-F evaluates quality of life using 5 categories: PWB, SWB, EWB, FWB, and FS. Participants answer each item on a 5-point scale from 0 to 4. The total score is the sum of individual responses across all 5 categories and may range from 0 to 160. The FACIT-G (range 0 to 108) is the sum of scores for PWB, SWB, EWB, and FWB; the FACIT-F TOI (range 0 to 108) is the sum of scores for PWB, FWB, and FS; and the FACIT-F fatigue (range 0 to 52) is the sum of scores for the FS only. For derivations of the FACIT-F reported here, higher scores indicate better quality of life. The mean score at each timepoint was determined by averaging scores among all participants, and the change in score was calculated as [mean score at Week 32 minus mean score at Week 16].|Weeks 16 and 32|ITT2 Population. Participants with evaluable data at the designated visit (number shown = n) were included.||units on a scale||Standard Deviation|Mean
840849|NCT01332994|Secondary|Change From Baseline in Quality of Life as Assessed Using FACIT at Week 16|The FACIT-F evaluates quality of life using 5 categories: PWB, SWB, EWB, FWB, and FS. Participants answer each item on a 5-point scale from 0 to 4. The total score is the sum of individual responses across all 5 categories and may range from 0 to 160. The FACIT-G (range 0 to 108) is the sum of scores for PWB, SWB, EWB, and FWB; the FACIT-F TOI (range 0 to 108) is the sum of scores for PWB, FWB, and FS; and the FACIT-F fatigue (range 0 to 52) is the sum of scores for the FS only. For derivations of the FACIT-F reported here, higher scores indicate better quality of life. The mean score at each timepoint was determined by averaging scores among all participants, and the change in score was calculated as [mean score at Week 16 minus mean score at Baseline].|Baseline and Week 16|Main ITT Population. Participants with evaluable data at the designated visit (number shown = n) were included.||units on a scale||Standard Deviation|Mean
840908|NCT01338636|Primary|Changes From Baseline in Peak Exercise Mean Pulmonary Artery Pressure (mPAP), Transpulmonary Pressure Gradient (TPG), and Pulmonary Capillary Wedge Pressure (PCWP)|mPAP is measure of the blood pressure found in the main artery of the lung. TPG is the difference between mean pulmonary arterial pressure and left atrial pressure. PCWP is the pressure measured by wedging a pulmonary catheter with an inflated balloon into a small pulmonary arterial branch.|Baseline to Week 24|The analysis population included evaluable participants who completed the 24-week treatment period.||mmHg||Standard Deviation|Mean
840850|NCT01332994|Secondary|Quality of Life as Assessed Using Functional Assessment of Chronic Illness Therapy (FACIT)|The FACIT-F evaluates quality of life using 5 categories: physical well-being (PWB), social/family well-being (SWB), emotional well-being (EWB), functional well-being (FWB), and fatigue (FS). Participants answer each item on a 5-point scale from 0 to 4. The total score is the sum of individual responses across all 5 categories and may range from 0 to 160. The FACIT-General (FACIT-G; range 0 to 108) is the sum of scores for PWB, SWB, EWB, and FWB; the FACIT-Fatigue (FACIT-F) trial outcome index (TOI; range 0 to 108) is the sum of scores for PWB, FWB, and FS; and the FACIT-F fatigue (range 0 to 52) is the sum of scores for the FS only. For derivations of the FACIT-F reported here, higher scores indicate better quality of life. The mean score at each timepoint was determined by averaging scores among all participants.|Baseline and Week 16|Main ITT Population. Participants with evaluable data at the designated visit (number shown = n) were included.||units on a scale||Standard Deviation|Mean
840851|NCT01332994|Secondary|Percentage of Participants Achieving a Response According to HAQ-DI Criteria|The HAQ-DI evaluates participant-reported quality of life using 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other common activities such as running errands and performing household chores. Each category contains multiple questions, which are answered using a 4-point scale from 0 to 3. The overall index score is taken as an average of the individual item responses and may range from 0 to 3, where higher scores indicate more difficulty in daily living activities. Response was defined as a change in index score >0.22 from Baseline to Week 16.|Baseline and Week 16|Main ITT Population||percentage of participants|||Number
840852|NCT01332994|Secondary|Change From Week 16 to 32 in Quality of Life as Assessed Using HAQ-DI Among Nonresponding Participants Treated With Rituximab|The HAQ-DI evaluates participant-reported quality of life using 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other common activities such as running errands and performing household chores. Each category contains multiple questions, which are answered using a 4-point scale from 0 to 3. The overall index score is taken as an average of the individual item responses and may range from 0 to 3, where higher scores indicate more difficulty in daily living activities. The mean index score at each timepoint was determined by averaging the scores among all participants, and the change in score was calculated as [mean score at Week 32 minus the mean score at Week 16].|Weeks 16 and 32|ITT3 Population. Participants with evaluable data at the designated visit were included.||units on a scale||Standard Deviation|Mean
840853|NCT01332994|Secondary|Change From Week 16 to 32 in Quality of Life as Assessed Using HAQ-DI Among Participants Treated With 8 Courses of Tocilizumab|The HAQ-DI evaluates participant-reported quality of life using 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other common activities such as running errands and performing household chores. Each category contains multiple questions, which are answered using a 4-point scale from 0 to 3. The overall index score is taken as an average of the individual item responses and may range from 0 to 3, where higher scores indicate more difficulty in daily living activities. The mean index score at each timepoint was determined by averaging the scores among all participants, and the change in score was calculated as [mean score at Week 32 minus the mean score at Week 16].|Weeks 16 and 32|ITT2 Population. Participants with evaluable data at the designated visit were included.||units on a scale||Standard Deviation|Mean
840854|NCT01332994|Secondary|Change From Baseline in Quality of Life as Assessed Using HAQ-DI at Week 16|The HAQ-DI evaluates participant-reported quality of life using 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other common activities such as running errands and performing household chores. Each category contains multiple questions, which are answered using a 4-point scale from 0 to 3. The overall index score is taken as an average of the individual item responses and may range from 0 to 3, where higher scores indicate more difficulty in daily living activities. The mean index score at each timepoint was determined by averaging the scores among all participants, and the change in score was calculated as [mean score at Week 16 minus mean score at Baseline].|Baseline and Week 16|Main ITT Population. Participants with evaluable data at the designated visit were included.||units on a scale||Standard Deviation|Mean
840855|NCT01332994|Secondary|Quality of Life as Assessed Using HAQ-DI|The HAQ-DI evaluates participant-reported quality of life using 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other common activities such as running errands and performing household chores. Each category contains multiple questions, which are answered using a 4-point scale from 0 to 3. The overall index score is taken as an average of the individual item responses and may range from 0 to 3, where higher scores indicate more difficulty in daily living activities. The mean index score at each timepoint was determined by averaging the scores among all participants.|Baseline and Week 16|Main ITT Population. Participants with evaluable data at the designated visit (number shown = n) were included.||units on a scale||Standard Deviation|Mean
840856|NCT01332994|Secondary|Change From Week 16 to 32 in Quality of Life as Assessed Using SF-36 Scores Among Nonresponding Participants Treated With Rituximab|The SF-36 evaluates participant-rated quality of life using 8 domains: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, and mental health. The score for each section is the average of the individual question scores, which are scaled from 0 to 100, with higher scores indicating better functioning. The mean score at each timepoint was determined by averaging the scores among all participants, and the change in each domain score was calculated as [mean score at Week 32 minus mean score at Week 16].|Weeks 16 and 32|ITT3 Population. Participants with evaluable data at the designated visit (number shown = n) were included.||units on a scale||Standard Deviation|Mean
840857|NCT01332994|Secondary|Change From Week 16 to 32 in Quality of Life as Assessed Using SF-36 Scores Among Participants Treated With 8 Courses of Tocilizumab|The SF-36 evaluates participant-rated quality of life using 8 domains: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, and mental health. The score for each section is the average of the individual question scores, which are scaled from 0 to 100, with higher scores indicating better functioning. The mean score at each timepoint was determined by averaging the scores among all participants, and the change in each domain score was calculated as [mean score at Week 32 minus mean score at Week 16].|Weeks 16 and 32|ITT2 Population. Participants with evaluable data at the designated visit (number shown = n) were included.||units on a scale||Standard Deviation|Mean
840909|NCT01338649|Secondary|MSLT and Polysomnograph (PSG) Testing Will be Compared.|MSLT and PSG testing will take place prior to light intervention at screening 2 and post light intervention at week 4.|4 weeks||||||
840858|NCT01332994|Secondary|Change From Baseline in Quality of Life as Assessed Using SF-36 at Week 16|The SF-36 evaluates participant-rated quality of life using 8 domains: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, and mental health. The score for each section is the average of the individual question scores, which are scaled from 0 to 100, with higher scores indicating better functioning. The mean score at each timepoint was determined by averaging the scores among all participants, and the change in each domain score was calculated as [mean score at Week 16 minus mean score at Baseline].|Baseline and Week 16|Main ITT Population. Participants with evaluable data at the designated visit (number shown = n) were included.||units on a scale||Standard Deviation|Mean
840859|NCT01332994|Secondary|Quality of Life as Assessed Using Short Form 36 (SF-36)|The SF-36 evaluates participant-rated quality of life using 8 domains: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, and mental health. The score for each section is the average of the individual question scores, which are scaled from 0 to 100, with higher scores indicating better functioning. The mean score at each timepoint was determined by averaging the scores among all participants.|Baseline and Week 16|Main ITT Population. Participants with evaluable data at the designated visit (number shown = n) were included.||units on a scale||Standard Deviation|Mean
840860|NCT01332994|Secondary|Mean Number of Work Days Missed Per Week|Work days missed were documented by reason (either rheumatoid arthritis [RA] or other reasons) for each participant over the preceding 7-day period. The mean number of work days missed was calculated by averaging the number of days missed per week among all participants.|Baseline and Week 16|Main ITT Population. Employed participants with evaluable data at the designated visit (number shown = n) were included.||days||Standard Deviation|Mean
840861|NCT01332994|Secondary|Spearman's Rank Correlation Coefficient Between Percentage of B-Cells at Baseline and Difference in DAS28 Scores Between Baseline and Weeks 16, 32, 40, 48, and 66 Among Nonresponding Participants Treated With Rituximab|Blood samples were collected to analyze total B-cell panel via immunophenotyping. Subpopulations were as follows: transitional, naïve, pre-switch memory, post-switch memory, IgG-positive class-switched, IgA-positive class-switched, double-negative memory, and plasmablasts. Naive B-cell compartment was defined as the sum of transitional and naive B-cells. The sum of memory B-cell subsets with or without double-negative B-cells was also determined. Extent of disease response, using change from Baseline in DAS28 score, was correlated to the percentage of B-cells within each subpopulation at Baseline. Correlation is indicated by a correlation coefficient (r) >0.2, with greater values indicating a stronger correlation.|Baseline and Weeks 16, 32, 40, 48, and 66|ITT3 Population; n = number of data pairs included in the analysis.||coefficient|Participants||Number
840862|NCT01332994|Secondary|Spearman's Rank Correlation Coefficient Between Percentage of B-Cells at Baseline and Difference in DAS28 Scores Between Baseline and Weeks 16, 24, and 32 Among Participants Treated With 8 Courses of Tocilizumab|Blood samples were collected to analyze total B-cell panel via immunophenotyping. Subpopulations were as follows: transitional, naïve, pre-switch memory, post-switch memory, IgG-positive class-switched, IgA-positive class-switched, double-negative memory, and plasmablasts. Naive B-cell compartment was defined as the sum of transitional and naive B-cells. The sum of memory B-cell subsets with or without double-negative B-cells was also determined. Extent of disease response, using change from Baseline in DAS28 score, was correlated to the percentage of B-cells within each subpopulation at Baseline. Correlation is indicated by a correlation coefficient (r) >0.2, with greater values indicating a stronger correlation.|Baseline and Weeks 16, 24, and 32|ITT2 Population; n = number of data pairs included in the analysis.||coefficient|Participants||Number
840863|NCT01332994|Secondary|Spearman's Rank Correlation Coefficient Between Percentage of B-Cells at Baseline and Difference in DAS28 Scores Between Baseline and Week 16 Among Participants With Early Remission|Blood samples were collected to analyze total B-cell panel via immunophenotyping. Subpopulations were as follows: transitional, naïve, pre-switch memory, post-switch memory, IgG-positive class-switched, IgA-positive class-switched, double-negative memory, and plasmablasts. Naive B-cell compartment was defined as the sum of transitional and naive B-cells. The sum of memory B-cell subsets with or without double-negative B-cells was also determined. Extent of disease response, using change from Baseline to Week 16 in DAS28 score, was correlated to the percentage of B-cells within each subpopulation at Baseline. Correlation is indicated by a correlation coefficient (r) >0.2, with greater values indicating a stronger correlation.|Baseline and Week 16|ITT1 Population; n = number of data pairs included in the analysis.||coefficient|Participants||Number
840864|NCT01332994|Secondary|Percentage of B-Cells at Baseline by B-Cell Subpopulation Among Nonresponding Participants Treated With Rituximab|Blood samples were collected to analyze total B-cell panel via immunophenotyping. Subpopulations were as follows: transitional (cluster of differentiation [CD] 19-positive, immunoglobulin (Ig) D-positive, CD38 medium, CD10-positive); naive (CD19-positive, IgD-positive, CD38 medium, CD27-negative); pre-switch memory (CD19-positive, CD27-positive, IgD-positive); post-switch memory (CD19-positive, CD27-positive, IgD-negative); IgG-positive class-switched (CD19-positive, IgG-positive); IgA-positive class-switched (CD19-positive, IgA-positive); double-negative memory (CD19-positive, IgD-negative, CD27-negative); and plasmablasts (CD19-positive, IgD-negative, CD38 high, CD27 high). Naive B-cell compartment was defined as the sum of transitional and naive B-cells. The sum of memory B-cell subsets with or without double-negative B-cells was also determined.|Baseline|ITT3 Population. Participants with evaluable data at the designated visit (number shown = n) were included.||percentage of B-cells||Full Range|Median
840865|NCT01332994|Secondary|Percentage of B-Cells at Baseline by B-Cell Subpopulation Among Participants Treated With 8 Courses of Tocilizumab|Blood samples were collected to analyze total B-cell panel via immunophenotyping. Subpopulations were as follows: transitional (cluster of differentiation [CD] 19-positive, immunoglobulin (Ig) D-positive, CD38 medium, CD10-positive); naive (CD19-positive, IgD-positive, CD38 medium, CD27-negative); pre-switch memory (CD19-positive, CD27-positive, IgD-positive); post-switch memory (CD19-positive, CD27-positive, IgD-negative); IgG-positive class-switched (CD19-positive, IgG-positive); IgA-positive class-switched (CD19-positive, IgA-positive); double-negative memory (CD19-positive, IgD-negative, CD27-negative); and plasmablasts (CD19-positive, IgD-negative, CD38 high, CD27 high). Naive B-cell compartment was defined as the sum of transitional and naive B-cells. The sum of memory B-cell subsets with or without double-negative B-cells was also determined.|Baseline|ITT2 Population. Participants with evaluable data at the designated visit (number shown = n) were included.||percentage of B-cells||Full Range|Median
840866|NCT01332994|Secondary|Percentage of B-Cells at Baseline by B-Cell Subpopulation Among Participants With Early Remission|Blood samples were collected to analyze total B-cell panel via immunophenotyping. Subpopulations were as follows: transitional (cluster of differentiation [CD] 19-positive, immunoglobulin (Ig) D-positive, CD38 medium, CD10-positive); naive (CD19-positive, IgD-positive, CD38 medium, CD27-negative); pre-switch memory (CD19-positive, CD27-positive, IgD-positive); post-switch memory (CD19-positive, CD27-positive, IgD-negative); IgG-positive class-switched (CD19-positive, IgG-positive); IgA-positive class-switched (CD19-positive, IgA-positive); double-negative memory (CD19-positive, IgD-negative, CD27-negative); and plasmablasts (CD19-positive, IgD-negative, CD38 high, CD27 high). Naive B-cell compartment was defined as the sum of transitional and naive B-cells. The sum of memory B-cell subsets with or without double-negative B-cells was also determined.|Baseline|ITT1 Population: All participants who received at least one dose of TCZ in the first treatment period and who completed the study reaching remission at Week 16. Participants with evaluable data at the designated visit (number shown = n) were included.||percentage of B-cells||Full Range|Median
840867|NCT01332994|Secondary|Percentage of Participants Withdrawing From the Study for Insufficient Therapeutic Response|Study discontinuation was documented by reason for each participant prematurely withdrawing from the study. The percentage of participants was calculated as the number withdrawing for insufficient therapeutic response divided by the total number of participants who began treatment.|Baseline to Week 16|Main ITT Population. Participants who withdrew for reasons other than insufficient therapeutic response were not included in the analysis.||percentage of participants||95% Confidence Interval|Number
840868|NCT01332994|Secondary|Change From Baseline in ESR at Weeks 20, 24, 28, and 32 Among Participants Treated With 8 Courses of Tocilizumab|Blood samples for laboratory assessments, including ESR, were collected prior to each dose of study medication. The mean ESR was determined at Baseline and for assessment visits by averaging the observed ESR among all participants providing evaluable blood samples. Change from Baseline was calculated as [mean ESR at the assessment visit minus mean ESR at Baseline] and expressed in mm/h.|Baseline and Weeks 20, 24, 28, and 32|ITT2 Population. Participants with evaluable data at the designated visit (number shown = n) were included.||mm/h||Standard Deviation|Mean
840869|NCT01332994|Secondary|Change From Baseline in CRP at Weeks 20, 24, 28, and 32 Among Participants Treated With 8 Courses of Tocilizumab|Blood samples for laboratory assessments, including CRP level, were collected prior to each dose of study medication. The mean CRP level was determined at Baseline and for assessment visits by averaging the observed CRP level among all participants providing evaluable blood samples. Change from Baseline was calculated as [mean CRP at the assessment visit minus mean CRP at Baseline] and expressed in mg/dL.|Baseline and Weeks 20, 24, 28, and 32|ITT2 Population. Participants with evaluable data at the designated visit (number shown = n) were included.||mg/dL||Standard Deviation|Mean
840870|NCT01332994|Secondary|Change From Baseline in Hemoglobin at Weeks 20, 24, 28, and 32 Among Participants Treated With 8 Courses of Tocilizumab|Blood samples for laboratory assessments, including hemoglobin level, were collected prior to each dose of study medication. The mean hemoglobin level was determined at Baseline and for assessment visits by averaging the observed hemoglobin level among all participants providing evaluable blood samples. Change from Baseline was calculated as [mean hemoglobin at the assessment visit minus mean hemoglobin at Baseline] and expressed in g/L.|Baseline and Weeks 20, 24, 28, and 32|ITT2 Population. Participants with evaluable data at the designated visit (number shown = n) were included.||g/L||Standard Deviation|Mean
840871|NCT01332994|Secondary|Change in ESR From Week 16 to 32 Among Nonresponding Participants Treated With Rituximab|Blood samples for laboratory assessments, including ESR, were collected prior to each dose of study medication. The mean ESR was determined at Baseline and for assessment visits by averaging the observed ESR among all participants providing evaluable blood samples. Change was calculated as [mean ESR at Week 32 minus mean ESR at Week 16] and expressed in mm/h.|Weeks 16 and 32|ITT3 Population. Participants with evaluable data at the designated visit were included.||mm/h||Standard Deviation|Mean
840872|NCT01332994|Secondary|Change in CRP From Week 16 to 32 Among Nonresponding Participants Treated With Rituximab|Blood samples for laboratory assessments, including CRP level, were collected prior to each dose of study medication. The mean CRP level was determined at Baseline and for assessment visits by averaging the observed CRP level among all participants providing evaluable blood samples. Change was calculated as [mean CRP at Week 32 minus mean CRP at Week 16] and expressed in mg/dL.|Weeks 16 and 32|ITT3 Population. Participants with evaluable data at the designated visit were included.||mg/dL||Standard Deviation|Mean
840873|NCT01332994|Secondary|Change in Hemoglobin From Week 16 to 32 Among Nonresponding Participants Treated With Rituximab|Blood samples for laboratory assessments, including hemoglobin level, were collected prior to each dose of study medication. The mean hemoglobin level was determined at Baseline and for assessment visits by averaging the observed hemoglobin level among all participants providing evaluable blood samples. Change was calculated as [mean hemoglobin at Week 32 minus mean hemoglobin at Week 16] and expressed in g/L.|Weeks 16 and 32|ITT3 Population. Participants with evaluable data at the designated visit were included.||g/L||Standard Deviation|Mean
840874|NCT01332994|Secondary|Change From Baseline in ESR at Weeks 4, 8, 12, and 16|Blood samples for laboratory assessments, including ESR, were collected prior to each dose of study medication. The mean ESR was determined at Baseline and for assessment visits by averaging the observed ESR among all participants providing evaluable blood samples. Change from Baseline was calculated as [mean ESR at the assessment visit minus mean ESR at Baseline] and expressed in millimeters per hour (mm/h).|Baseline and Weeks 4, 8, 12, and 16|Main ITT Population. Participants with evaluable data at the designated visit (number shown = n) were included.||mm/h||Standard Deviation|Mean
840875|NCT01332994|Secondary|Change From Baseline in CRP at Weeks 4, 8, 12, and 16|Blood samples for laboratory assessments, including CRP level, were collected prior to each dose of study medication. The mean CRP level was determined at Baseline and for assessment visits by averaging the observed CRP level among all participants providing evaluable blood samples. Change from Baseline was calculated as [mean CRP at the assessment visit minus mean CRP at Baseline] and expressed in milligrams per deciliter (mg/dL).|Baseline and Weeks 4, 8, 12, and 16|Main ITT Population. Participants with evaluable data at the designated visit (number shown = n) were included.||mg/dL||Standard Deviation|Mean
840913|NCT01338792|Secondary|Number of Participants With Serious Adverse Events (SAEs)|Safety evaluation according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|Baseline, days 1 and 7 of each course, and at last evaluation, up to 1 year|All participants who started treatment were included.||Participants|||Number
840877|NCT01332994|Secondary|Change From Baseline in CDAI and SDAI Scores at Weeks 20, 24, 28, and 32 Among Participants Treated With 8 Courses of Tocilizumab|The CDAI was calculated as [SJC + TJC + VAS patient global assessment of disease activity + VAS physician global assessment of disease activity]. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.' CDAI scores ranged from 0 to 76, with higher scores indicating increased disease activity. The SDAI was determined by adding CRP level to the CDAI score. Scores ranged from 0 to 86, with higher scores also indicating increased disease activity. A reduction in either score at the assessment visit reflects improvement in disease.|Baseline and Weeks 20, 24, 28, and 32|ITT2 Population. Participants with evaluable data at the designated visit (number shown = n) were included.||units on a scale||Standard Deviation|Mean
840878|NCT01332994|Secondary|Change From Week 16 to 32 in CDAI and SDAI Scores Among Nonresponding Participants Treated With Rituximab|The CDAI was calculated as [SJC + TJC + VAS patient global assessment of disease activity + VAS physician global assessment of disease activity]. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.' CDAI scores ranged from 0 to 76, with higher scores indicating increased disease activity. The SDAI was determined by adding CRP level to the CDAI score. Scores ranged from 0 to 86, with higher scores also indicating increased disease activity. A reduction in either score at the assessment visit reflects improvement in disease.|Weeks 16 and 32|ITT3 Population. Participants with evaluable data at the designated visit (number shown = n) were included.||units on a scale||Standard Deviation|Mean
840879|NCT01332994|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) Scores at Weeks 4, 8, 12, and 16|The CDAI was calculated as [SJC + TJC + VAS patient global assessment of disease activity + VAS physician global assessment of disease activity]. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.' CDAI scores ranged from 0 to 76, with higher scores indicating increased disease activity. The SDAI was determined by adding CRP level to the CDAI score. Scores ranged from 0 to 86, with higher scores also indicating increased disease activity. A reduction in either score at the assessment visit reflects improvement in disease.|Baseline and Weeks 4, 8, 12, and 16|Main ITT Population. Participants with evaluable data at the designated visit (number shown = n) were included.||units on a scale||Standard Deviation|Mean
840880|NCT01332994|Secondary|Percentage of Participants Achieving a Response According to ACR Criteria at Weeks 20, 24, 28, and 32 Among Participants Treated With 8 Courses of Tocilizumab|Response was determined using ACR criteria based upon assessment of 66 joints for swelling and 68 joints for tenderness; joints were classified dichotomously as swollen or not swollen and tender or not tender. Respectively, these assessments were used to generate an SJC ranging from 0 to 66 swollen joints and a TJC ranging from 0 to 68 tender joints. Response was defined as a reduction from Baseline of at least 20% for one of the following: VAS scores for patient-reported pain, patient global assessment of disease activity, or physician global assessment of disease activity, HAQ-DI, or CRP; plus a reduction in individual SJC and TJC of 20% (ACR20), 50% (ACR50), or 70% (ACR70). VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.'|Baseline and Weeks 20, 24, 28, and 32|ITT2 Population||percentage of participants||95% Confidence Interval|Number
840881|NCT01332994|Secondary|Percentage of Participants Achieving a Response According to ACR Criteria at Week 32 Compared to Week 16 Among Nonresponding Participants Treated With Rituximab|Response was determined using ACR criteria based upon assessment of 66 joints for swelling and 68 joints for tenderness; joints were classified dichotomously as swollen or not swollen and tender or not tender. Respectively, these assessments were used to generate an SJC ranging from 0 to 66 swollen joints and a TJC ranging from 0 to 68 tender joints. Response was defined as a reduction from the reference visit (Week 16) of at least 20% for one of the following: VAS scores for patient-reported pain, patient global assessment of disease activity, or physician global assessment of disease activity, HAQ-DI, or CRP; plus a reduction in individual SJC and TJC of 20% (ACR20), 50% (ACR50), or 70% (ACR70). VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.'|Weeks 16 and 32|ITT3 Population||percentage of participants||95% Confidence Interval|Number
840882|NCT01332994|Secondary|Percentage of Participants Achieving a Response According to American College of Rheumatology (ACR) Criteria at Weeks 4, 8, 12, and 16|Response was determined using ACR criteria based upon assessment of 66 joints for swelling and 68 joints for tenderness; joints were classified dichotomously as swollen or not swollen and tender or not tender. Respectively, these assessments were used to generate a swollen joint count (SJC) ranging from 0 to 66 swollen joints and a tender joint count (TJC) ranging from 0 to 68 tender joints. Response was defined as a reduction from Baseline of at least 20% for one of the following: VAS scores for patient-reported pain, patient global assessment of disease activity, or physician global assessment of disease activity, Health Assessment Questionnaire Disability Index (HAQ-DI), or C-reactive protein (CRP); plus a reduction in individual SJC and TJC of 20% (ACR20), 50% (ACR50), or 70% (ACR70). VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.'|Baseline and Weeks 4, 8, 12, and 16|Main ITT Population||percentage of participants||95% Confidence Interval|Number
840883|NCT01332994|Secondary|Percentage of Participants Achieving a Response According to EULAR Criteria at Weeks 20, 24, 28, and 32 Among Participants Treated With 8 Courses of Tocilizumab|Response was determined using EULAR criteria based upon DAS28 absolute scores at the assessment visit and the DAS28 reduction from Baseline. Participants with a score ≤3.2 and reduction of >1.2 points were assessed as having a 'good' response. Participants with a score >3.2 with reduction of >1.2 points, or a score ≤5.1 with reduction of >0.6 to ≤1.2 points, were assessed as having a 'moderate' response. Participants with a score >5.1 with reduction of >0.6 to ≤1.2 points, or any score with reduction ≤0.6 points, were assessed as nonresponders with response recorded as 'none.'|Baseline and Weeks 20, 24, 28, and 32|ITT2 Population||percentage of participants||95% Confidence Interval|Number
840893|NCT01332994|Secondary|Percentage of Participants Achieving LDAS According to DAS28 Among Among Nonresponding Participants Treated With Rituximab|The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x the patient global assessment of disease activity using a VAS]. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.' DAS28 scores ranged from 0 to 10, with higher scores indicating increased disease activity. LDAS was defined as a DAS28 score <3.2 at the assessment visit.|Week 32|ITT3 Population||percentage of participants||95% Confidence Interval|Number
840884|NCT01332994|Secondary|Percentage of Participants Achieving a Response According to EULAR Criteria at Week 32 Compared to Week 16 Among Nonresponding Participants Treated With Rituximab|Response was determined using EULAR criteria based upon DAS28 absolute scores at the assessment visit and the DAS28 reduction from the reference visit (Week 16). Participants with a score ≤3.2 and reduction of >1.2 points were assessed as having a 'good' response. Participants with a score >3.2 with reduction of >1.2 points, or a score ≤5.1 with reduction of >0.6 to ≤1.2 points, were assessed as having a 'moderate' response. Participants with a score >5.1 with reduction of >0.6 to ≤1.2 points, or any score with reduction ≤0.6 points, were assessed as nonresponders with response recorded as 'none.'|Weeks 16 and 32|ITT3 Population||percentage of participants||95% Confidence Interval|Number
840885|NCT01332994|Secondary|Percentage of Participants Achieving a Response According to European League Against Rheumatism (EULAR) Criteria at Weeks 4, 8, 12 and 16|Response was determined using EULAR criteria based upon DAS28 absolute scores at the assessment visit and the DAS28 reduction from Baseline. Participants with a score ≤3.2 and reduction of >1.2 points were assessed as having a 'good' response. Participants with a score >3.2 with reduction of >1.2 points, or a score ≤5.1 with reduction of >0.6 to ≤1.2 points, were assessed as having a 'moderate' response. Participants with a score >5.1 with reduction of >0.6 to ≤1.2 points, or any score with reduction ≤0.6 points, were assessed as nonresponders with response recorded as 'none.'|Baseline and Weeks 4, 8, 12, and 16|Main ITT Population||percentage of participants||95% Confidence Interval|Number
840886|NCT01332994|Secondary|DAS28 Scores During Safety Follow-Up Among Nonresponding Participants Treated With Rituximab|The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x VAS patient global assessment of disease activity]. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.' DAS28 scores ranged from 0 to 10, with higher scores indicating increased disease activity.|Weeks 40, 48, 56, and 66|ITT3 Population. Participants with evaluable data at the designated visit (number shown = n) were included.||units on a scale||Standard Deviation|Mean
840887|NCT01332994|Secondary|DAS28 Scores During and After Treatment Among Nonresponding Participants Treated With Rituximab|The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x VAS patient global assessment of disease activity]. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.' DAS28 scores ranged from 0 to 10, with higher scores indicating increased disease activity.|Baseline and Weeks 4, 8, 12, 16, 24, and 32|ITT3 Population. Participants with evaluable data at the designated visit (number shown = n) were included.||units on a scale||Standard Deviation|Mean
840888|NCT01332994|Secondary|DAS28 Scores During and After Treatment Among Participants Treated With 8 Courses of Tocilizumab|The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x VAS patient global assessment of disease activity]. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.' DAS28 scores ranged from 0 to 10, with higher scores indicating increased disease activity.|Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, and 32|ITT2 Population. Participants with evaluable data at the designated visit (number shown = n) were included.||units on a scale||Standard Deviation|Mean
840889|NCT01332994|Secondary|DAS28 Scores During and After Treatment|The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x VAS patient global assessment of disease activity]. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.' DAS28 scores ranged from 0 to 10, with higher scores indicating increased disease activity.|Baseline and Weeks 4, 8, 12, 16|Main ITT Population. Participants with evaluable data at the designated visit (number shown = n) were included.||units on a scale||Standard Deviation|Mean
840890|NCT01332994|Secondary|Percentage of Participants Achieving a Clinically Relevant Reduction in DAS28 From Week 16 to Week 32 Among Nonresponding Participants Treated With Rituximab|The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x VAS patient global assessment of disease activity]. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.' DAS28 scores ranged from 0 to 10, with higher scores indicating increased disease activity. Reductions >1.2 points from the reference visit (Week 16) to the assessment visit were considered clinically relevant.|Weeks 16 and 32|ITT3 Population: All participants who received at least one dose of TCZ in the first treatment period and at least one dose of RTX in the second treatment period with at least one efficacy measurement under RTX.||percentage of participants||95% Confidence Interval|Number
840891|NCT01332994|Secondary|Percentage of Participants Achieving a Clinically Relevant Reduction From Baseline in DAS28 at Weeks 4, 8, and 12|The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x VAS patient global assessment of disease activity]. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.' DAS28 scores ranged from 0 to 10, with higher scores indicating increased disease activity. Reductions >1.2 points from Baseline to the assessment visit were considered clinically relevant.|Baseline and Weeks 4, 8, and 12|Main ITT Population||percentage of participants||95% Confidence Interval|Number
840892|NCT01332994|Secondary|Percentage of Participants Achieving a Clinically Relevant Reduction From Baseline in DAS28 at Week 16|The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x VAS patient global assessment of disease activity]. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.' DAS28 scores ranged from 0 to 10, with higher scores indicating increased disease activity. Reductions >1.2 points from Baseline to the assessment visit were considered clinically relevant.|Baseline and Week 16|Main ITT Population||percentage of participants||95% Confidence Interval|Number
840906|NCT01338636|Primary|Change From Baseline in Peak Exercise Pulmonary Vascular Compliance (PVC )|PVC is a measure of a pulmonary vein's ability to expand.|Baseline to Week 24|The analysis population included evaluable participants who completed the 24-week treatment period.||mL/mmHg||Standard Deviation|Mean
840894|NCT01332994|Secondary|Percentage of Participants Achieving Low Disease Activity Score (LDAS) According to DAS28|The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x the patient global assessment of disease activity using a VAS]. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.' DAS28 scores ranged from 0 to 10, with higher scores indicating increased disease activity. LDAS was defined as a DAS28 score <3.2 at the assessment visit.|Week 16|Main ITT Population||percentage of participants||95% Confidence Interval|Number
840895|NCT01332994|Secondary|Percentage of Participants Achieving Remission According to DAS28 at Week 32 Among Nonresponding Participants Treated With Rituximab|The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x VAS patient global assessment of disease activity]. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.' DAS28 scores ranged from 0 to 10, with higher scores indicating increased disease activity. Remission was defined as a DAS28 score <2.6 at the assessment visit.|Week 32|ITT3 Population||percentage of participants||95% Confidence Interval|Number
840896|NCT01332994|Secondary|Percentage of Participants Achieving Remission According to DAS28 at Week 32 Among Participants Treated With 8 Courses of Tocilizumab|The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x VAS patient global assessment of disease activity]. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.' DAS28 scores ranged from 0 to 10, with higher scores indicating increased disease activity. Remission was defined as a DAS28 score <2.6 at the assessment visit.|Week 32|ITT2 Population||percentage of participants||95% Confidence Interval|Number
840897|NCT01332994|Secondary|Percentage of Participants Achieving Remission According to DAS28 at Weeks 16, 20, 24, and 28 Among Participants Treated With 8 Courses of Tocilizumab|The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x VAS patient global assessment of disease activity]. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.' DAS28 scores ranged from 0 to 10, with higher scores indicating increased disease activity. Remission was defined as a DAS28 score <2.6 at the assessment visit.|Weeks 16, 20, 24, and 28|ITT2 Population: All participants who received at least one dose of TCZ in the first treatment period with at least one efficacy measurement under TCZ, receiving TCZ in the second treatment period.||percentage of participants||95% Confidence Interval|Number
840898|NCT01332994|Secondary|Percentage of Participants Achieving Remission According to DAS28 at Weeks 4, 8, and 12|The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x VAS patient global assessment of disease activity]. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.' DAS28 scores ranged from 0 to 10, with higher scores indicating increased disease activity. Remission was defined as a DAS28 score <2.6 at the assessment visit.|Weeks 4, 8, and 12|Main ITT Population||percentage of participants||95% Confidence Interval|Number
840899|NCT01332994|Primary|Percentage of Participants Achieving Remission at Week 16 According to DAS28|The DAS28 was calculated as [0.28 times (x) the square root of number of swollen joints] plus (+) [0.56 x the square root of number of tender joints] + [0.7 x the natural log of erythrocyte sedimentation rate (ESR)] + [0.014 x Visual Analog Scale (VAS) patient global assessment of disease activity]. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.' DAS28 scores ranged from 0 to 10, with higher scores indicating increased disease activity. Remission was defined as a DAS28 score <2.6 at the assessment visit.|Week 16|Main ITT Population||percentage of participants||95% Confidence Interval|Number
840900|NCT01338610|Primary|Visual Analog Scale (VAS) Global Ocular Discomfort Score, Area Under the Curve, Day 0 to Day 28|An electronic Visual Analog Scale (eVAS) was used by the subject to assess ocular discomfort, both frequency and severity, at Day 0 (pre-treatment) and daily thereafter for 28 days. Assessments were entered into a LogPad® (handheld electronic device). The VAS frequency score ranged from 0 (rarely) to 100 (all the time), and the VAS severity score ranged from 0 (very mildly uncomfortable) to 100 (very severely uncomfortable). The Global Ocular Discomfort Score is a composite of the frequency and severity VAS scores (0-100).|Up to 28 days|All subjects randomized to treatment and receiving at least 1 administration of study medication (intent-to-treat). Mixed model repeated measure (MMRM) approach was used to handle missing data during randomized treatment period.||Units on a scale x days||Standard Error|Least Squares Mean
840901|NCT01338636|Secondary|World Health Organization Functional Class (WHO FC)|The WHO FC categorizes cardiac disability using four classes, ranging from Class 1 (without limitation of physical activity) to Class 4 (inability to carry on any physical activity without discomfort).|Baseline and Week 24|The analysis population included evaluable participants who completed the 24-week treatment period.||class||Standard Deviation|Mean
840902|NCT01338636|Secondary|Borg Dyspnea Scale Score|The Borg Dyspnea Scale measures how breathless the participant feels. Scores range from 0 (no shortness of breath) to 10+ (more short of breath than ever experienced). A score greater that 10 represents very extreme shortness of breath.|Baseline and Week 24|The analysis population included evaluable participants who completed the 24-week treatment period.||score on a scale||Standard Deviation|Mean
840903|NCT01338636|Secondary|Change From Baseline in 6-minute Walk Distance (6MWD)|6MWD is the distance walked by the participant in 6 minutes.|Baseline to Week 24|The analysis population included evaluable participants who completed the 24-week treatment period.||meters||Standard Deviation|Mean
840904|NCT01338636|Primary|Change From Baseline in Peak Exercise Maximum Oxygen Uptake (VO2max)|VO2max is the measurement of the maximum amount of oxygen that an individual can utilize during intense or maximal exercise.|Baseline to Week 24|The analysis population included evaluable participants who completed the 24-week treatment period.||percent predicted||Standard Deviation|Mean
840905|NCT01338636|Primary|Change From Baseline in Peak Exercise Cardiac Output (CO)|CO is the amount of blood pumped by the heart per minute.|Baseline to Week 24|The analysis population included evaluable participants who completed the 24-week treatment period.||L/min||Standard Deviation|Mean
840914|NCT01338792|Secondary|Time to Disease Progression and Overall Survival|Progression-free survival was defined as the time from the first infusion of study treatment to the date of radiographic disease progression according to RECIST 1.0, or until two consecutive PSA rises occurred with an absolute increase of 5 ng/mL and a 50% relative increase over baseline. For patients without documented disease progression, the date of death or last follow-up without disease progression was used.|Baseline, after every 2 courses, and then every 6 months after off-study (RECIST) until progression; or baseline, day 1 of each course, at the final evaluation, and then every 6 months after off-study (PSA) until progression|Participants who received at least the first infusion of treatment were included.||Months||95% Confidence Interval|Mean
840915|NCT01338792|Primary|Best Overall Response|For patients with measurable disease, the RECIST 1.0 criteria was used to determine response. Complete Response = disappearance of all target lesions, Partial Response = greater or equal to 30% decrease in sum of longest diameter or target lesions, Stable Disease = <30% decrease or <20% increase, Progressive Disease = greater or equal to 20% increase in longest diameter of target lesions. For patients who do not have measurable disease by RECIST, the response was based on PSA response defined by Prostate Cancer Working Group criteria (1999) as 50% reduction in PSA confirmed on a second measurement at least 4 weeks later.|RECIST evaluation: Baseline, after every 2 courses, and then every 6 months after off-study, up to 1 year. PSA evaluation: baseline, day 1 of each course, final evaluation, and then every 6 months after off-study, up to 1 year|All participants who received at least 1 cycle of treatment were included.||Participants|||Number
840916|NCT01338818|Secondary|Change From Extension Baseline (Week 40) to End of Study (Week 66) on Sheehan Disability Scale (SDS) Total Score|SDS,5-self-rated questionnaire to measure the extent a pt’s disability due to an illness/health problem interferes with work/school,social life/leisure,family life/home. First 3 items, pts are asked how their symptoms disrupted their regular activities over the past 7d in each using a scale from 0(not at all)-10(extremely) Each subscale(work disability, social life disability, family life disability)can be scored independently or combined into a total score(sum of the non-missing responses for items 1-3)from 0-30,higher scores indicate significant functional impairment. Subscale scores>5 suggest impairment in that subscale area. Final 2 items ask pts about the # of days their symptoms caused them to miss school/work and # of days their symptoms caused them to be underproductive at school/work.(These items were not included in the total score.) Before responding to SDS items 1-3, pts were verbally instructed to recall the past 7d, items 4-5 refer to the last week w/in the item wording.|week 40 - week 66|All Extension Patients(AEP) analysis set was used for all efficacy and safety analyses of the extension study. AEP was ALL patients who had entered the extension study & received at least 1 dose of Ritalin LA. Enrolment was 299, but 1 pt entered the extension but didn’t receive 1 dose of Ritalin LA and was excluded from AEP Population analysis.||Scores on a scale||Standard Deviation|Mean
840917|NCT01338818|Secondary|Change From Extension Baseline (Week 40) to End of Study (Week 66) in on DSM-IV Attention-Deficit/Hyperactivity Disorder Rating Scale (DSM-IV ADHD RS) Total Score.|"Attention-Deficit/Hyperactivity Disorder Rating Scale (DSM-IV ADHD RS) total score consists of 18 items directly adapted from the ADHD symptom list according to the DSM-IV. The DSM-IV ADHD RS total score was calculated as the sum of the Inattentive and the Hyperactive-Impulsive subscores. The 18 items are rated from 0 (rarely or never) to 3 (Very often). The total score ranges from 0 to 54. Decrease in the DSM-IV ADHD RS total score indicates improvement, therefore a greater decrease (change at Final Visit compared to baseline) indicates a greater improvement in ADHD symptoms. Last Observation Carried Forward (LOCF) applied for each patient with data in extension period. If no post-baseline is available, it is considered as missing."|week 40 - week 66|All Extension Patients(AEP) analysis set was used for all efficacy and safety analyses of the extension study. AEP was ALL patients who had entered the extension study & received at least 1 dose of Ritalin LA. Enrolment was 299, but 1 pt entered the extension but didn’t receive 1 dose of Ritalin LA and was excluded from AEP Population analysis.||scores on a scale||Standard Deviation|Mean
840918|NCT01338818|Primary|Number of Participants With Adverse Events, Serious Adverse Events and Deaths.|Adverse Events, Serious Adverse Events and Deaths were monitored from week 40 to week 66.|Week 40 - Week 66|All Extension Patients(AEP) analysis set was used for all efficacy and safety analyses of the extension study. AEP was ALL patients who had entered the extension study & received at least 1 dose of Ritalin LA. Enrolment was 299, but 1 pt entered the extension but didn’t receive 1 dose of Ritalin LA and was excluded from AEP Population analysis.||participants|||Number
840919|NCT01338857|Primary|Objective Response Rates|Determination of tumor response (CR, PR, SD) will be defined based on the comparison of the baseline MRI performed at study entry to the subsequent MRI which demonstrated best response. PR will be defined by a >15% decrease in tumor volume, as measured by 3D volumetric analysis.|MRIs performed after every 3rd 28-day cycle and off-study|Study terminated and 1/12 participants completed and data was analyzed||participants|||Number
840920|NCT01338857|Primary|Response Rate to Sorafenib|To estimate the objective response rates to sorafenib in children and young adults with low-grade astrocytomas, including optic pathway gliomas.|one year|Study terminated and 1/12 participants completed and data was analyzed||participants|||Number
840921|NCT01338870|Secondary|Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Loss in Body Weight From Baseline|The treatment of diabetes has been the recommendation to lose weight. As weight loss progresses and is maintained, an improvement of glycemia may be evidenced by a reduction in HbA1c. Participants with >= 1% or >= 2% loss in body weight from baseline signifies an improvement of glycemia.|Week 12|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signify those who were evaluable for this measure.||percentage of participants|||Number
840922|NCT01338870|Secondary|Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Gain in Body Weight From Baseline|Overweight or obesity increases the risk for developing diabetes. Participants with >= 1% or >= 2% gain in body weight from baseline signifies a higher risk of diabetes.|Week 12|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signify those who were evaluable for this measure.||percentage of participants|||Number
840972|NCT01339923|Secondary|Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination - Groups B_02_2_5 and B_02_6_10|Safety was assessed in terms of number of subjects with solicited local and systemic AEs after any vaccination in subjects aged 2 - 10 years who received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Analysis was done on solicited safety set.|Within 30 minutes after any vaccination|Solicited safety set||Number of subjects|||Number
840923|NCT01338870|Secondary|Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12|Overweight or obesity increases the risk for developing diabetes. The treatment of diabetes has been the recommendation to lose weight. As weight loss progresses and is maintained, an improvement of glycemia may be evidenced by a reduction in HbA1c.|Baseline, Week 1, 2, 4, 8, 12|FAS included all randomized participants who received at least 1 dose of study medication. Here ‘n’ signifies participants who were evaluable at specific time point for each treatment arm respectively.||kilogram (kg)||Standard Deviation|Mean
840924|NCT01338870|Secondary|Percentage of Participants Achieving Less Than (<) 6.5% or <7% Glycosylated Hemoglobin (HbA1c) Levels|HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The normal range for the HbA1c test is between 4% and 5.6%. HbA1c levels between 5.7% and 6.4% indicate increased risk of diabetes, and levels of 6.5% or higher indicate diabetes.|Week 12|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signify those who were evaluable for this measure.||percentage of participants|||Number
840925|NCT01338870|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 1, 2, 4 and 8|HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The normal range for the HbA1c test is between 4% and 5.6%. HbA1c levels between 5.7% and 6.4% indicate increased risk of diabetes and levels of 6.5% or higher indicate diabetes.|Baseline, Week 1, 2, 4, 8|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signify those who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specific time point for each treatment arm respectively.||percentage of hemoglobin||Standard Deviation|Mean
840926|NCT01338870|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12||Baseline, Week 1, 2, 4, 8, 12|FAS included all randomized participants who received at least 1 dose of study medication. Here ‘n’ signifies participants who were evaluable at specific time point for each treatment arm respectively.||milligram/deciliter (mg/dL)||Standard Deviation|Mean
840927|NCT01338870|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12|HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The normal range for the HbA1c test is between 4 percent (%) and 5.6%. HbA1c levels between 5.7% and 6.4% indicate increased risk of diabetes and levels of 6.5% or higher indicate diabetes.|Baseline, Week 12|Full analysis set (FAS) included all randomized participants who received at least 1 dose of study medication. Here ‘n’ signifies participants who were evaluable at specific time point for each treatment arm respectively.||percentage of hemoglobin||Standard Deviation|Mean
840928|NCT01339247|Primary|Cmax_ss|Cmax_ss is defined as the maximum or “peak” concentration of a drug observed after its administration, in steady-state. Cmax_ss is one of the parameters of particular use in estimating the bioavailability of drugs, by measuring the total amount of drug absorbed.|Days 14 to 17 (period 1) and Days 23 to 24 (Period 2)|Entire study population||ng/ml||Standard Deviation|Mean
840929|NCT01339247|Primary|Cmin_ss|Cmin_ss is defined as the minimum concentration of a drug observed after its administration, in steady-state. Cmin_ss is one of the parameters of particular use in estimating the bioavailability of drugs, for studies employing multiple doses.|Days 14 to 17 (period 1) and Days 23 to 24 (Period 2)|Entire study population||ng/ml||Standard Deviation|Mean
840930|NCT01339247|Primary|AUC_ss|The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC_ss is the area under the curve during the steady-state period. The AUC_ss is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. ng, nanograms; h, hour; ml, milliliter; ng.h/ml, nanograms per hour per milliliter.|Days 14 to 17 (period 1) and Days 23 to 24 (Period 2)|Entire study population||ng.h/ml||Standard Deviation|Mean
840931|NCT01339260|Secondary|Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, at Cycle 1||0-120 hours|FAS||percentage of responders||95% Confidence Interval|Number
840932|NCT01339260|Secondary|Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication at Cycle 1||0-24 hours|FAS||percentage of responders||95% Confidence Interval|Number
840933|NCT01339260|Primary|Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, at Cycle 1||25-120 hours|FAS||percentage of responders||95% Confidence Interval|Number
840934|NCT01339299|Primary|The Oestradiol Concentration on the Day of Ovulation Induction||treatment day 10 to 14|||pmol/L||Standard Deviation|Mean
840935|NCT01339390|Primary|Change in Weight (From Baseline)|Weight as recorded in the medical record during a 6-month period around the follow-up point.|Measured at 12 and 24 months|For the analysis, we included those lost to follow up by using the last observation carried forward to impute missing values||Pounds||Standard Deviation|Least Squares Mean
840936|NCT01339403|Primary|Incidence Rate of Viral Encephalitis|Incidence rate of viral encephalitis (VE) was calculated as the number of events divided by person-time. Only the first diagnosis of each event per participant was included. Person-time was calculated as the sum of all time contributed by each individual who were KP member from the date of HIV care initiation at that institution or January 1, 1996 for KPNC and January 1, 2000 for KPSC if in care prior to this date. Incidence rate was computed as the number of events per 100,000 person-years. The participants with viral encephalitis were followed-up up to 31st December 2009 (730 Weeks).|Up to Week 730|Analysis population included all participants enrolled in the study.||VE per 100,000 person-years|||Number
840937|NCT01339403|Primary|Incidence Rate of All-Cause Mortality|Incidence rate of all-cause mortality was calculated as the number of events divided by person-time. Only the first diagnosis of each event per participant was included. Person-time was calculated as the sum of all time contributed by each individual who were KP member from the date of HIV care initiation at that institution or January 1, 1996 for KPNC and January 1, 2000 for KPSC if in care prior to this date. Incidence rate was computed as the number of events per 100,000 person-years.|Up to Week 835|Analysis population included all participants enrolled in the study.||death per 100,000 person-years|||Number
841039|NCT01340209|Secondary|Weekly Mean Score of Asthma Symptoms During the Day (Response)|"Response of weekly mean score of asthma symptoms during the day at week 52. Response was defined as change from baseline.
5-point verbal rating scale, with answer 1 representing no impairment at all and answer 5 representing the greatest impairment."|baseline and week 52|Full analysis set||Scores on a scale||Standard Deviation|Mean
840938|NCT01339403|Primary|Incidence Rate of Rhabdomyolysis|Incidence rate of Rhabdomyolysis was calculated as the number of events divided by person-time. Only the first diagnosis of each event per participant was included. Person-time was calculated as the sum of all time contributed by each individual who were KP member from the date of HIV care initiation at that institution or January 1, 1996 for KPNC and January 1, 2000 for KPSC if in care prior to this date. Incidence rate was computed as the number of events per 100,000 person-years.|Up to Week 835|Analysis population included all participants enrolled in the study.||rhabdomyolysis per 100,000 person-years|||Number
840939|NCT01339403|Primary|Incidence Rate of Liver Related Death|Incidence rate of liver related death was calculated as the number of events divided by person-time. Only the first diagnosis of each event per participant was included. Person-time was calculated as the sum of all time contributed by each individual who were KP member from the date of HIV care initiation at that institution or January 1, 1996 for KPNC and January 1, 2000 for KPSC if in care prior to this date. Incidence rate was computed as the number of events per 100,000 person-years.|Up to Week 835|Analysis population included all participants enrolled in the study.||death per 100,000 person-years|||Number
840940|NCT01339403|Primary|Incidence Rate of Liver Failure|Incidence rate of liver failure was calculated as the number of events divided by person-time. Only the first diagnosis of each event per participant was included. Person-time was calculated as the sum of all time contributed by each individual who were KP member from the date of HIV care initiation at that institution or January 1, 1996 for KPNC and January 1, 2000 for KPSC if in care prior to this date. Incidence rate was computed as the number of events per 100,000 person-years.|Up to Week 835|Analysis population included all participants enrolled in the study.||liver failure per 100,000 person-years|||Number
840941|NCT01339403|Primary|Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections|Incidence rate of AIDS-defining opportunistic infections (OI) was calculated as the number of events divided by person-time.Only the first diagnosis of each event per participant was included.Person-time was calculated as the sum of all time contributed by each individual who were KP member from the date of HIV care initiation at that institution or January 1,1996 for KPNC and January 1,2000 for KPSC if in care prior to this date.OI were those that occurred on immune-compromised participants.AIDS-defining infections included:wasting syndrome;pneumocystis jirovecii pneumonia;recurrent pneumonia;cytomegalovirus;HIV-related encephalopathy;esophageal candidiasis;mycobacterium avium complex;cryptococcosis;mycobacterium tuberculosis;progressive multifocal leukoencephalopathy;lung candidiasis;toxoplasmosis of brain;coccidiomycosis;histoplasmosis;recurrent salmonella septicemia;chronic isosporiasis;cryptosporidiosis.Incidence rate was computed as the number of events per 100,000 person-years.|Up to Week 835|Analysis population included all participants enrolled in the study.||infections per 100,000 person-years|||Number
840942|NCT01339403|Primary|Incidence Rate of Myocardial Infarction and Ischemia|Incidence rate of cardiovascular (CVS)events including myocardial infarction (MI) and ischemia was calculated as the number of events divided by person-time. Only the first diagnosis of each event per participant was included. Person-time was calculated as the sum of all time contributed by each individual who were KP member from the date of HIV care initiation at that institution or January 1, 1996 for KPNC and January 1, 2000 for KPSC if in care prior to this date. Incidence rate was computed as the number of events per 100,000 person-years.|Up to Week 835|Analysis population included all participants enrolled in the study.||CVS events per 100,000 person-years|||Number
840943|NCT01339403|Primary|Incidence Rate of Malignancies|Incidence rate of malignancies was calculated as the number of events divided by person-time. Only the first diagnosis of each event per participant was included.Person-time was calculated as the sum of all time contributed by each individual who were Kaiser Permanente (KP) member from the date of HIV care initiation at that institution or January 1, 1996 for KP Northern California(KPNC) and January 1, 2000 for KP Southern California(KPSC) if in care prior to this date. Malignancies included acquired immunodeficiency syndrome (AIDS)-defining malignancies and non-AIDS defining malignancies.AIDS-defining malignancies included invasive cervical cancer,invasive non-Hodgkin's lymphoma and kaposi's sarcoma;non-AIDS defining malignancies cancers ascertained from the KP cancer registries.Overall data for non-AIDS and AIDS defining malignancies, along with individual data for AIDS-defining malignancies was reported. Incidence rate was computed as the number of events per 100,000 person-years.|Up to Week 835|Analysis population included all participants enrolled in the study.||malignancies per 100,000 person-years|||Number
840944|NCT01339416|Secondary|Incidence Rate of Death|Incidence rate of death was calculated as the number of events divided by person-time. Person-time was calculated as the sum of all time contributed by each individual from the date of HIV care initiation at that institution or January 1, 2000 if in care prior to this date. All-cause mortality was used for the analyses.|Up to Week 626|Analysis population included all participants enrolled in the study.||death per 100 person-years||95% Confidence Interval|Number
840945|NCT01339416|Secondary|Incidence Rate of Rhabdomyolysis|Incidence rate of rhabdomyolysis was calculated as the number of events divided by person-time. Only first diagnosis of the event per participant was included. Person-time was calculated as the sum of all time contributed by each individual from the date of HIV care initiation at that institution or January 1, 2000 if in care prior to this date. Rhabdomyolysis was a condition of muscle fibers breakdown.|Up to Week 626|Analysis population included all participants enrolled in the study.||rhabdomylosis per 100 person-years||95% Confidence Interval|Number
840946|NCT01339416|Primary|Incidence Rate of Viral Encephalitis|Incidence rate of viral encephalitis was calculated as the number of events divided by person-time. Only first diagnosis of the event per participant was included. Person-time was calculated as the sum of all time contributed by each individual from the date of HIV care initiation at that institution or January 1, 2000 if in care prior to this date. Viral encephalitis was defined as inflammation of the brain due to virus.|Up to Week 626|Analysis population included all participants enrolled in the study.||viral encephalitis per 100 person-years||95% Confidence Interval|Number
840947|NCT01339416|Primary|Incidence Rate of Liver Failure|Incidence rate of liver failure was calculated as the number of events divided by person-time. Only first diagnosis of the event per participant was included. Person-time was calculated as the sum of all time contributed by each individual from the date of HIV care initiation at that institution or January 1, 2000 if in care prior to this date.|Up to Week 626|Analysis population included all participants enrolled in the study.||liver failure per 100 person-years||95% Confidence Interval|Number
840948|NCT01339416|Primary|Incidence Rate of Myocardial Infarction|Incidence rate of myocardial infarction (MI) was calculated as the number of events divided by person-time. Only first diagnosis of the event per participant was included. Person-time was calculated as the sum of all time contributed by each individual from the date of HIV care initiation at that institution or January 1, 2000 if in care prior to this date.|Up to Week 626|Analysis population included all participants enrolled in the study.||MI per 100 person-year||95% Confidence Interval|Number
840949|NCT01339416|Primary|Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections|Incidence rate of AIDS-defining opportunistic infections was calculated as the number of events divided by person-time. Only the first diagnosis of each event per participant was included. Person-time was calculated as the sum of all time contributed by each individual from the date of HIV care initiation at that institution or January 1, 2000 if in care prior to this date. Opportunistic infections were those that occurred on immune-compromised participants. AIDS-defining infections included: esophageal candidiasis; pneumocystes jiroveci; non-tuberculous mycobacterium infection; AIDS dementia complex; disseminated cryptococcosis; cytomegalovirus (all sites); wasting syndrome; toxoplasmosis; cytomegalovirus retinitis; mycobacterium tuberculosis; Progressive (Prog.) multifocal leukoencephalopathy; histoplasmosis; cryptosporidiosis; recurrent pneumonia; herpes simplex infection; extra-pulmonary coccidioidomycosis; salmonella septicemia; isosporiasis.|Up to Week 626|Analysis population included all participants enrolled in the study.||infections per 100 person-years||95% Confidence Interval|Number
840950|NCT01339416|Primary|Incidence Rate of Malignancies|Incidence rate of malignancies was calculated as the number of events divided by person-time. Only the first diagnosis of each event per participant was included. Person-time was calculated as the sum of all time contributed by each individual from the date of HIV care initiation at that institution or January 1, 2000 if in care prior to this date. Malignancies included acquired immunodeficiency syndrome (AIDS)-defining malignancies and non-AIDS defining malignancies. AIDS-defining malignancies included invasive cervical cancer, non-Hodgkin's lymphoma and kaposis sarcoma; non-AIDS defining malignancies included but not limited to Hodgkin’s disease, lung cancer, liver cancer, anal cancer, melanoma of the skin, leukemia, renal cancer, and prostate cancer. Overall data for non-AIDS defining malignancies and individual data for AIDS-defining malignancies was reported. Incidence rate was computed as the number of events per 100 person-years.|Up to Week 626|Analysis population included all participants enrolled in the study. Here, n=participants who were evaluable for this measure at given time points for each group, respectively.||malignancies per 100 person-years||95% Confidence Interval|Number
840951|NCT01339429|Secondary|Number of Participants With Serious Adverse Events|Any adverse events, including bleeding, wound complication, or change in patient condition during the trial period will be recorded.|3 days|||participants|Participants||Number
840952|NCT01339429|Primary|Maintenance of Negative Pressure|The negative pressure being delivered by the device was measured on a daily basis for three days. Maintenance of negative pressure was defined as negative pressure delivery within 75% of the starting negative pressure amount.|3 days|85 dressings were applied. 5 applications excluded due to a change in patient condition, unrelated to sNPWT. 9 dressings excluded due to occlusion of the drainage tube. 71 dressings were analyzed in total.||hours|Participants|Standard Deviation|Mean
840953|NCT01339832|Secondary|Incidence of Adverse Event (AE) and Serious Adverse Event (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes|Up to 5 years|Full Analysis Set (FAS) included all the participants who fulfilled the inclusion criteria for this study. This population includes participants who gave informed consent and also those who died or were lost to follow-up before start of ML21875 study.||participants|||Number
840954|NCT01339832|Secondary|Long Term Side Effects|Long term side effects for bowel and urinary function was assessed. Bowel function was assessed in terms of mean bowel frequency, regular use of constipating agents as well as fecal incontinence. Urinary function was evaluated according to the presence (YES or NO) of incontinence. Overall participant satisfaction was assessed in terms of satisfaction with bowel, stoma and urinary function on a 4-stage scale (very good, good, poor, and very poor). In case of different assessment(s) of bowel or urinary function within the same surveillance period, the assessment with worst grade was documented and reported.|Up to 5 years|Full Analysis Set (FAS) included all the participants who fulfilled the inclusion criteria for this study. This population includes participants who gave informed consent and also those who died or were lost to follow-up before start of ML21875 study.||participants|||Number
840955|NCT01339832|Secondary|Compliance to Diagnostic Procedures in Surveillance|The surveillance compliance was calculated per participant in percent and frequencies for methods of diagnostic procedure adhered to, taking into account all expected procedures in the time span the participant participated and was based on the Swiss Society of Gastroenterology (SGG) follow-up care recommendations|Up to 5 years|Full Analysis Set (FAS) included all the participants who fulfilled the inclusion criteria for this study. This population includes participants who gave informed consent and also those who died or were lost to follow-up before start of ML21875 study.||participants|||Number
840956|NCT01339832|Secondary|Length of Adjuvant Chemotherapy|The length of adjuvant chemotherapy was defined as time between first start date to last stop date of adjuvant chemotherapy regimen. Length of adjuvant chemotherapy was calculated as length [days] = last stop date - first start date + 1, missing day of start and stop date was replaced by 1.|Up to 5 years|Full Analysis Set (FAS) included all the participants who fulfilled the inclusion criteria for this study. This population includes participants who gave informed consent and also those who died or were lost to follow-up before start of ML21875 study.||days||Full Range|Median
840957|NCT01339832|Secondary|Type of Adjuvant Chemotherapy|The type of therapies administered after primary treatments (chemotherapy, surgery or radiation) was reported|Up to 5 years|Full Analysis Set (FAS) included all the participants who fulfilled the inclusion criteria for this study. This population includes participants who gave informed consent and also those who died or were lost to follow-up before start of ML21875 study.||participants|||Number
840958|NCT01339832|Secondary|Tumor Recurrence Rate (Local and Distant)|Participant with tumor recurrence were determined by the presence or absence of date of tumor recurrence detection. In case of absence of empty tumor recurrence date it was considered that the participant had not experienced tumor recurrence. Participants with local tumor recurrence (’Was it local to the primary tumor?’ answered ‘yes’.) compared to participants with distant tumor recurrence (specification for other tumor location given).|Up to 5 years|Full Analysis Set (FAS) included all the participants who fulfilled the inclusion criteria for this study. This population includes participants who gave informed consent and also those who died or were lost to follow-up before start of ML21875 study.||participants|||Number
840959|NCT01339832|Secondary|Overall Survival|Overall survival (OS) was defined as time from date of first administration of the study medication in ML18280 study to date of death from any cause. Participants without documented date of death were assumed to be alive and were censored at the latest of the following dates: last date alive on survival status pages, last date known to be alive on survival status pages, and last date of tumor assessment (diagnostic procedures or markers) on surveillance pages. OS time in days was calculated as OS [days] =date of death date of first intake+ 1, for participants who died, OS [days]= censoring date date of first intake+ 1, for participants alive, and OS time in months was calculated as OS [months]= 12 *OS [days] /365.25|Up to 5 years|Full Analysis Set (FAS) included all the participants who fulfilled the inclusion criteria for this study. This population includes participants who gave informed consent and also those who died or were lost to follow-up before start of ML21875 study.||months||Full Range|Median
840960|NCT01339832|Primary|Progression-free Survival|Progression free survival (PFS) was measured from the date of first administration of study medication in ML18280 study to the date of progression or death, whatever the cause. In participants with measurable disease, progression was defined according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.0. Participants with neither tumor recurrence nor death were censored at the last tumor assessment date they were known to have not progressed (last date of diagnostic procedure or diagnostic marker reported in the surveillance). PFS time in days was calculated as PFS [days]= date of tumor recurrence/death date of first intake + 1, if participant had tumor recurrence confirmed by diagnostic imaging or participant died, then PFS [days] =last diagnostic procedure/marker date- date of first intake+ 1, and if participant survived without tumor recurrence PFS time in months was calculated as PFS [months]= 12 * PFS [days] /365.25|Up to 5 years|Full Analysis Set (FAS) included all the participants who fulfilled the inclusion criteria for this study. This population includes participants who gave informed consent and also those who died or were lost to follow-up before start of ML21875 study.||months||Full Range|Median
840961|NCT01339897|Secondary|Pharmacokinetics of N6022 Cmax Values on Study Day 7|Pharmacokinetic Analysis of N6022 Cmax values on Study Day 7|Day 7, 24 hours|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
840962|NCT01339897|Secondary|Pharmacokinetics of N6022 on Study Day 1|Analysis of N6022 Cmax values on Study Day 1|Day 1, 24 hours|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
840963|NCT01339897|Secondary|Pharmacokinetics of N6022 Over 7 Days|Analysis of N6022 AUC0-tau values from Study Day 7|Day 7, 24 hours|N6022 AUC0-tau values from Study Day 7||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
840964|NCT01339897|Secondary|Pharmacokinetics of N6022|N6022 AUC0-tau measurements from Day 1|Day 1, 24 hours|Any subject that completed N6022 or placebo PK sampling||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
840965|NCT01339897|Primary|Safety of Escalating Multiple Doses of N6022 in Healthy Subjects|Safety variables (adverse events, vital signs, physical examination, telemetry, 12-lead ECG, infusion site reactions, O2 saturation, and clinical laboratory assessments)|Over 7 days|Any subject that received any dose of N6022 or placebo.||participants|||Number
840966|NCT01339923|Secondary|Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Group BC_35_12 and C_35_12|Safety was assessed in terms of number of subjects reporting any unsolicited AEs (day 1-7 after any vaccination), serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal from the study (collected throughout the study period) following any vaccination with rMenB+OMV NZ or MenC-CRM. Analysis was done on unsolicited safety set.|Day 1 to Day 301 for BC_35_12 and C_35_12, Day 302 to Day 391 for C_35_12; Day 1 to day 7 (All AEs)|Unsolicited safety set||Number of subjects|||Number
840967|NCT01339923|Secondary|Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Groups B_02_2_5 and B_02_6_10|Safety was assessed in terms of number of subjects reporting any unsolicited AEs (day 1-7 after any vaccination), serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal from the study (collected throughout the study period) following any vaccination with rMenB+OMV NZ. Analysis was done on unsolicited safety set.|Day 1 to day 7 (All AEs). Throughout the study period (SAEs, medically attended or leading to premature withdrawal AEs)|Unsolicited safety set||Number of subjects|||Number
840968|NCT01339923|Secondary|Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Groups B_2h3h5_11, B_3h5_11 and B_68_11|Safety was assessed in terms of number of subjects reporting any unsolicited AEs (day 1-7 after any vaccination), serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal from the study (collected throughout the study period) following any vaccination with rMenB+OMV. Analysis was done on unsolicited safety set.|Until 12 months of age; Day 1 to day 7 (All AEs)|Unsolicited safety set||Number of subjects|||Number
840969|NCT01339923|Secondary|Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination|Safety was assessed in terms of number of subjects with solicited local and systemic AEs after any vaccination with rMenB+OMV NZ or MenC-CRM. Analysis was done on solicited safety set.|Day 1 to day 7 after any vaccination|Solicited safety set||Number of subjects|||Number
840970|NCT01339923|Secondary|Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any rMenB+OMV NZ or MenC-CRM Vaccination|Safety was assessed in terms of number of subjects with solicited local and systemic AEs after any vaccination with rMenB+OMV NZ or MenC-CRM. Analysis was done on solicited safety set.|Within 30 minutes after any vaccination|Solicited safety set||Number of subjects|||Number
840971|NCT01339923|Secondary|Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10|Safety was assessed in terms of number of subjects with solicited local and systemic AEs after any vaccination in subjects aged 2- 10 years who received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Analysis was done on solicited safety set.|Day 1 to day 7 after any vaccination|Solicited safety set||Number of subjects|||Number
840973|NCT01339923|Secondary|Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ|Safety was assessed in terms of number of subjects with solicited local and systemic AEs after any vaccination following a 4-dose regimen (2.5, 3.5, 5 and 11 months) or as a 3-dose regimen (3.5, 5 and 11 months or 6, 8 and 11 months) of rMenB+OMV NZ. Analysis was done on solicited safety set.|Day 1 to day 7 after any vaccination|Solicited safety set||Number of subjects|||Number
840974|NCT01339923|Secondary|Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ|Safety was assessed in terms of number of subjects who reported immediate reactions within 30 minutes following a 4-dose regimen (2.5, 3.5, 5 and 11 months) or a 3-dose regimen (3.5, 5 and 11 months or 6, 8 and 11 months) of rMenB+OMV NZ. Analysis was done on solicited safety set.|Within 30 minutes after any vaccination|Solicited safety set.||Number of subjects|||Number
840975|NCT01339923|Secondary|Geometric Mean ELISA Concentrations Against Vaccine Antigen 287-953 Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM - Persistence|Immunogenicity was assessed in terms of GMTs against Geometric mean ELISA concentrations against N meningitidis serogroup B vaccine antigen 287-953, following co-administration of MenC-CRM and rMenB+OMV NZ at 3 and 5 months and booster dose at 12 months. Analysis was done on FAS-persistence.|Pre-booster vaccination (persistence; 12 months of age)|FAS-persistence||IU/mL||95% Confidence Interval|Geometric Mean
840976|NCT01339923|Secondary|Geometric Mean ELISA Concentrations Against Vaccine Antigen 287-953 Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM|Immunogenicity was assessed in terms of Geometric mean ELISA concentrations against N meningitidis serogroup B vaccine antigen 287-953, following co-administration of MenC-CRM and rMenB+OMV NZ at 3 and 5 months and booster dose at 12 months. Analysis was done on FAS-primary and FAS-booster.|1 month after second vaccination, pre-booster vaccination and 1 month after booster vaccination|FAS-primary and FAS-booster||IU/mL||95% Confidence Interval|Geometric Mean
840977|NCT01339923|Secondary|GMTs Against N. Meningitidis Serogroup B Strains Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM|Immunogenicity was assessed in terms of GMTs against N meningitidis serogroup C strain following co-administration of MenC-CRM and rMenB+OMV NZ at 3 and 5 months and booster dose at 12 months. Analysis was done on FAS-persistence and FAS-booster.|1 month after second vaccination, pre-booster vaccination and 1 month after booster vaccination|FAS-persistence and FAS-booster||Titers||95% Confidence Interval|Geometric Mean
840978|NCT01339923|Secondary|Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM|Immunogenicity was assessed in terms of percentages of subjects with hSBA titers ≥ 4 against N meningitidis serogroup B strains H44/76, 5/99, NZ98/254; hSBA titers ≥ 5 against strain M10713; hSBA titers ≥ 8 against strains H44/76, 5/99, NZ98/254, M10713; following co-administration of MenC-CRM and rMenB+OMV NZ at 3 and 5 months and a booster at 12 months. Analysis was done on FAS-primary series and FAS-booster.|1 month after second vaccination and 1 month after booster vaccination|FAS-primary series and FAS-booster||Percentages of subjects||95% Confidence Interval|Number
840979|NCT01339923|Secondary|GMTs Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM or MenC-CRM Alone - Persistence|Immunogenicity was assessed in terms of GMTs against N meningitidis serogroup C strain following co-administration of MenC-CRM and rMenB+OMV NZ or MenC-CRM alone at 3 and 5 months and booster dose at 12 months. Analysis was done on FAS-persistence.|Pre-booster vaccination (persistence; 12 months of age)|FAS-persistence||Titers||95% Confidence Interval|Geometric Mean
840980|NCT01339923|Secondary|GMTs Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM or MenC-CRM Alone|Immunogenicity was assessed in terms of GMTs against N meningitidis serogroup C strain following co-administration of MenC-CRM and rMenB+OMV NZ or MenC-CRM alone at 3 and 5 months and booster dose at 12 months. Analysis was done on FAS-primary series and FAS-booster.|1 month after second vaccination, 1 month after booster vaccination|FAS-primary series and FAS-booster||Titers||95% Confidence Interval|Geometric Mean
840981|NCT01339923|Secondary|Percentages of Subjects With hSBA Titers ≥ 8 Against Serogroup C Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM or MenC-CRM Alone|Non-inferiority of MenC-CRM was determined following co-administration of MenC-CRM and rMenB+OMV NZ or MenC-CRM alone at 3 and 5 months and booster dose at 12 months, as measured by the percentages of subjects achieving hSBA titers ≥ 8 against serogroup C. Analysis was done on PPS-primary series and PPS-booster.|Baseline, 1 month after second vaccination and 1 month after booster vaccination|PPS-primary series and PPS-booster.||Percentages of subjects||95% Confidence Interval|Number
840982|NCT01339923|Secondary|Geometric Mean ELISA Concentrations Against Vaccine Antigen 287-953 After a Two Dose Catch-up rMenB+OMV NZ Immunization Series in Children 2-10 Years of Age|Immunogenicity was assessed in terms of Geometric mean ELISA concentrations (GMCs) against N meningitidis serogroup B vaccine antigen 287-953, after a two dose catch-up immunization series with rMenB+OMV NZ in children 2-10 years of age. Analysis was done on FAS-primary series.|1 month after second vaccination|FAS-primary series||IU/mL||95% Confidence Interval|Geometric Mean
840983|NCT01339923|Secondary|Geometric Mean ELISA Concentrations Against Vaccine Antigen 287-953 Following 2 or 3-dose Primary Series and Booster Dose of Vaccination With rMenB+OMV NZ|Immunogenicity was assessed in terms of Geometric mean ELISA concentrations (GMCs) against N meningitidis serogroup B vaccine antigen 287-953, following 2 or 3 dose primary series and booster dose of rMenB+OMV NZ. Analysis was done on FAS-persistence and FAS-booster.|1 month after primary vaccination, pre-booster vaccination (persistence) and 1 month after booster vaccination|FAS-persistence and FAS-booster||IU/mL||95% Confidence Interval|Geometric Mean
840984|NCT01339923|Secondary|Antibody Persistence in Terms of Geometric Mean Titers Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ|Persistence of bactericidal antibodies at 11 months of age was assessed in terms of GMTs against N meningitidis serogroup B indicator strains in subjects who previously received a primary series of 2 or 3-doses of rMenB+OMV NZ. Analysis was done on FAS-persistence.|11 months of age (persistence)|FAS-persistence||Titers||95% Confidence Interval|Geometric Mean
841040|NCT01340209|Secondary|Weekly Mean Score of Asthma Symptoms in the Morning (Response)|"Response of weekly mean score of asthma symptoms in the morning at week 52. Response was defined as change from baseline.
5-point verbal rating scale, with answer 1 representing no impairment at all and answer 5 representing the greatest impairment."|baseline and week 52|Full analysis set||Scores on a scale||Standard Deviation|Mean
840985|NCT01339923|Secondary|Antibody Persistence in Terms of Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ|Persistence of bactericidal antibodies at 11 months of age was assessed in terms of percentages of subjects with hSBA titers ≥ 4 against N meningitidis serogroup B strains H44/76, 5/99, NZ98/254; hSBA titers ≥ 5 against strain M10713; hSBA titers ≥ 8 against strains H44/76, 5/99, NZ98/254, M10713 in subjects who previously received a primary series of 2 or 3-doses of rMenB+OMV NZ vaccine. Analysis was done on FAS-persistence.|11 months of age (persistence)|FAS-persistence||Percentages of subjects||95% Confidence Interval|Number
840986|NCT01339923|Secondary|Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 Following a Booster Dose of rMenB+OMV Vaccination|Immunogenicity was assessed in terms of percentages of subjects with hSBA titers ≥ 4 against N meningitidis serogroup B strains H44/76, 5/99, NZ98/254; hSBA titers ≥ 5 against strain M10713; hSBA titers ≥ 8 against strains H44/76, 5/99, NZ98/254, M10713; following a booster dose of rMenB+OMV NZ given at 11 months of age (4th dose for B_2h3h5_11 and 3rd dose for B_3h5_11 and B_68_11). Analysis was done on FAS-booster.|1 month post-booster dose|FAS-booster||Percentages of subjects||95% Confidence Interval|Number
840987|NCT01339923|Secondary|Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 After First Infant Vaccination With rMenB+OMV|Immunogenicity was assessed in terms of percentages of subjects with hSBA titers ≥ 4 against N meningitidis serogroup B strains H44/76, 5/99, NZ98/254, hSBA titers ≥ 5 against strain M10713 and hSBA titers ≥ 8 against strains H44/76, 5/99, NZ98/254, M10713 after the first infant vaccination in groups B_2h3h5_11b, B_3h5_11b and B_68_11b (at 3.5, 5, and 8 months of age respectively). Analysis was done on FAS-post first dose.|Post- first dose (1 month for B_2h3h5_11b, 1.5 month for B_3h5_11b and 2 months for B_68_11b after 1st vaccination)|FAS-post first dose||Percentages of subjects||95% Confidence Interval|Number
840988|NCT01339923|Secondary|Geometric Mean hSBA Titers (GMTs) After First Infant Vaccination With rMenB+OMV.|Immunogenicity was assessed in terms of Geometric mean hSBA titers (GMTs) against N meningitidis serogroup B indicator strains after the first infant vaccination in groups B_2h3h5_11b, B_3h5_11b and B_68_11b (after 1 month for group B_2h3h5_11b, 1.5 months for group B_2h3h5_11b and 2 months for group B_68_11b). Analysis was done on FAS-post first dose.|1, 1.5 or 2 months after first infant vaccination|FAS-post first dose||Titers||95% Confidence Interval|Geometric Mean
840989|NCT01339923|Secondary|Geometric Mean hSBA Titers (GMTs) Following 2 or 3 Dose Primary Series of Vaccination With rMenB+OMV|"Immunogenicity was assessed in terms of Geometric mean hSBA titers (GMTs) against N meningitidis serogroup B indicator strains following 2 or 3 dose primary series of vaccination rMenB+OMV NZ (1 month after 3rd infant vaccination in B_2h3h5_11 and 1 month after 2nd infant vaccination in B_3h5_11, B_68_11 and B_02).
Analysis was done on FAS-primary series."|1 month after primary series vaccination|FAS-primary series||Titers||95% Confidence Interval|Geometric Mean
840990|NCT01339923|Secondary|Percentages of Subjects Achieving Four-fold Rise Over Baseline hSBA Titers Following a 2-dose Catch-up Series of rMenB+OMV Vaccination|"Immunogenicity was assessed in terms of percentages of subjects achieving 4-fold increase in hSBA titers as compared to baseline against N meningitidis serogroup B strains H44/76, 5/99, NZ98/254, M10713; following 2-dose catch-up series of vaccination with rMenB+OMV NZ in healthy children aged 2-10 years (0, 2 month schedule).
Analysis was done on FAS- primary series."|1 month after second vaccination|FAS- primary series||Percentages of subjects||95% Confidence Interval|Number
840991|NCT01339923|Secondary|Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (Strain M10713) and hSBA ≥ 8 Following a 2-dose Catch-up Series of rMenB+OMV Vaccination|Immunogenicity was assessed in terms of percentages of subjects with hSBA titers ≥ 4 against N meningitidis serogroup B strains H44/76, 5/99, NZ98/254; hSBA titers ≥ 5 against strain M10713 and hSBA titers ≥ 8 against strains H44/76, 5/99, NZ98/254, M10713; following 2-dose catch-up series of vaccination with rMenB+OMV NZ in healthy children aged 2-10 years (0, 2 month schedule). Analysis was done on FAS-primary series.|1 month after second vaccination|FAS-primary series||Percentages of subjects||95% Confidence Interval|Number
840992|NCT01339923|Secondary|Percentages of Subjects With hSBA Titers ≥ 4, hSBA Titers ≥ 5 (Strain M10713) and hSBA ≥ 8 Following a 3-dose Primary Series of rMenB+OMV Vaccination|Immunogenicity was assessed in terms of percentages of subjects with hSBA titers ≥ 4 against N meningitidis serogroup B strains H44/76, 5/99, NZ98/254; hSBA titers ≥ 5 against strain M10713 and hSBA titers ≥ 8 against strains H44/76, 5/99, NZ98/254, M10713, following 3-dose primary series of vaccination with rMenB+OMV NZ at 2.5, 3.5 and 5 months of age. Analysis was done on FAS-primary series.|1 month after third vaccination|FAS-primary series||Percentages of subjects||95% Confidence Interval|Number
840993|NCT01339923|Primary|Percentages of Subjects With Serum Bactericidal Activity Using Human Serum (hSBA) Titers ≥ 4 or hSBA Titers ≥ 5 (Strain M10713) Following a 2-dose Primary Series of rMenB+OMV Vaccination.|Immunogenicity was assessed in terms of percentages of subjects with hSBA titers ≥ 4 against N meningitidis serogroup B strains H44/76, 5/99, NZ98/254 and hSBA titers ≥ 5 against strain M10713 following 2-dose primary series of vaccination with rMenB+OMV NZ at 3.5 and 5 months of age or at 6 and 8 months of age. Analysis was done on Full analysis set (FAS)-Primary series.|1 month after second vaccination|FAS-Primary series||Percentages of subjects||97.5% Confidence Interval|Number
840994|NCT01339936|Secondary|Ocular Surface Disease Index Score|"The OSDI is a 12-item patient-reported outcomes questionnaire designed to assess the range of ocular surface symptoms, their severity, and their impact on the patient’s ability to function.
The OSDI items are scored on a 0 to 4 Likert-type scale, where 0 = None of the time, 1 = Some of the time, 2 = Half of the time, 3 = Most of the time, and 4 = All of the time. Using individual item responses, an overall OSDI score is calculated. The overall OSDI score ranges from 0 to 100, where a score of 100 corresponds to complete disability while a score of 0 corresponds to no disability."|after 30 days of eye drop usage|||points||Standard Deviation|Mean
840995|NCT01339936|Secondary|Tear Break Up Time|The tear film break-up-time (BUT) is the time elapsed between eye opening after a blink, and the appearance of the first dark spot within the tear film when observed with a wide diffuse light source of the Tearscope. This measurement is indicative of the tear film stability. Three independent measurements were recorded in each case and the median value over the three measurements calculated. The latter value constituted the secondary endpoint used in the analysis.|after 30 days of eyedrop usage|The analysis was carried out on subjects having completed the study according to the protocol e.g. 35||seconds||Standard Deviation|Mean
840996|NCT01339936|Primary|Tear Film Evaporation Rate|The rate of evaporation of the tears from the ocular surface was measured. To do so the participant was required to wear a sealed goggle over the eye, which served to isolate the air surrounding the ocular surface. The temperature and humidity were measured within the sealed goggle during closed eye and open eye situations. The evaporation from the ocular surface was calculated by taking the difference between the evaporation rate of the skin taken during the closed eye measurement and the evaporation rate taken during the open eye measurement. The rate of evaporation was measured in 10^-7 g/cm^2 /s and recorded for relative humidity of 25% to 35%.|after 30 days of eyedrop usage|The analysis was carried out on subjects having completed the study according to the protocol e.g. 35||10^-7g/cm^2/sec||Standard Deviation|Mean
840997|NCT01340014|Secondary|Ocular Discomfort|Ocular discomfort was assessed by the participant 1 minute after instillation of the study medication. Ocular discomfort was rated on a 10-point scale (0=no discomfort, 9=substantial discomfort).|Day 7 of each period|This reporting group includes all participants who completed both treatment periods and completed the preference questionnaire, as treated, minus any missing responses.||Units on a scale||Standard Deviation|Mean
840998|NCT01340014|Primary|Preferred Treatment|"The participant completed a questionnaire on the Day 15 visit (ie, after administration of both study medications) consisting of a single preference question: Thinking about the comfort of the two medications (1st and 2nd) that you took during this study, which medication do you prefer? Preferred treatment is presented as a percentage."|At the end of both periods, Day 15|This reporting group includes all participants who completed both treatment periods and completed the preference questionnaire, as treated.||Percentage of participants|||Number
840999|NCT01340027|Secondary|Change From Baseline to End of Treatment in Treatment Satisfaction on Visual Analog Scale (TS-VAS)|The TS-VAS is a visual analog scale (VAS) that asks patients to rate their satisfaction with treatment by placing a vertical mark on a 10 cm line where the endpoints are labeled 'No, not at all' on the left (=0) to 'Yes, completely satisfied' on the right (=10). A positive change from Baseline indicates improvement.|Baseline and Week 12|Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used||units on a scale||Standard Error|Least Squares Mean
841000|NCT01340027|Secondary|Change From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI)|This 6-item assessment measures productivity losses during the past 7 days and includes measures on work time missed due to health, impairment while working due to health (the participant’s assessment of the degree to which health affected their productivity while working), overall work impairment due to health (takes into account both hours missed due to health and the participant’s assessment of the degree to which health affected their productivity while working) and activity impairment due to health (the degree in which health problems affected their ability to do regular daily activities). Scores for each measure are expressed from 0 to 100 with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicates improvement.|Baseline and Week 12|Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used.||units on a scale||Standard Deviation|Mean
841001|NCT01340027|Secondary|Change From Baseline to End of Treatment in European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)|The EQ-5D is an international, standardized, generic instrument for describing and evaluating health status. Health status is assessed by patients evaluating their health on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (=0) and 'Best imaginable health state' (=100). On the EQ-5D VAS, a positive change from baseline indicates improvement.|Baseline and Week 12|Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used||units on a scale||Standard Deviation|Mean
841002|NCT01340027|Secondary|Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:
I am not anxious or depressed; I am moderately anxious or depressed; I am extremely anxious or depressed. In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of patients in that category."|Baseline and Week 12|Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used||participants|||Number
841003|NCT01340027|Secondary|Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:
I have no pain or discomfort; I have moderate pain or discomfort; I have extreme pain or discomfort. In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of participants in that category."|Baseline and Week 12|Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used||participants|||Number
841004|NCT01340027|Secondary|Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score|"The EQ-5D is a standardized, nondisease-specific instrument for describing health status. Participants were asked which statement best describes their health state with regard to usual activities (work, study or leisure): I have no problems performing my usual activities; I have some problems performing my usual activities; I am unable to perform my usual activities.
In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of patients in that category."|Baseline and Week 12|Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used||participants|||Number
841005|NCT01340027|Secondary|Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:
I have no problems with self-care; I have some problems washing or dressing myself; I am unable to wash or dress myself.
In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of patients in that category."|Baseline and Week 12|Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used||participants|||Number
841006|NCT01340027|Secondary|Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:
I have no problems in walking about; I have some problems in walking about; I am confined to bed.
In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of patients in that category."|Baseline and Week 12|Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used||participants|||Number
841007|NCT01340027|Secondary|Percentage of Participants With a Health-related Quality of Life Total Score Response|Health-related quality of life was assessed by the HRQL subscales (coping, concern, sleep and social interaction) of the overactive bladder questionnaire (OABq). The HRQL total score was calculated by adding the 4 HRQL subscale scores, and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. HRQL response is defined as improvement (decrease) of at least 10 points from Baseline.|Baseline and Week 12|Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used||percentage of participants|||Number
841008|NCT01340027|Secondary|Change From Baseline to End of Treatment in Health-related Quality of Life (HRQL) Total Score|Health-related quality of life was assessed by the HRQL subscales (coping, concern, sleep and social interaction) of the overactive bladder questionnaire (OABq). The HRQL total score was calculated by adding the 4 HRQL subscale scores, and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from Baseline in HRQL score indicates improvements.|Baseline and Week 12|Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used||units on a scale||Standard Error|Least Squares Mean
841009|NCT01340027|Secondary|Percentage of Participants With a Symptom Bother Response|Overactive bladder symptoms were assessed using the symptom bother scale of the overactive bladder questionnaire. The symptom bother scale consists of 8 questions answered by the participant on a scale from 1-6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. Symptom bother response is defined as improvement (decrease) of at least 10 points from Baseline.|Baseline and Week 12|Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used||percentage of participants|||Number
841010|NCT01340027|Secondary|Change From Baseline to End of Treatment in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q)|Overactive bladder symptoms were assessed using the symptom bother scale of the overactive bladder questionnaire. The symptom bother scale consists of 8 questions answered by the participant on a scale from 1-6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from Baseline in symptom bother score indicates improvements.|Baseline and Week 12|Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used||units on a scale||Standard Error|Least Squares Mean
841011|NCT01340027|Secondary|Percentage of Participants With Deterioration in PPBC|The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Deterioration was defined as at least a 1 point increase from Baseline in PPBC score.|Baseline and Week 12|Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used.||percentage of participants|||Number
841012|NCT01340027|Secondary|Percentage of Participants With Major Improvement in PPBC|The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Major improvement was defined as at least a 2-point improvement (decrease) from Baseline in PPBC score.|Baseline and Week 12|Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used.||percentage of participants|||Number
841013|NCT01340027|Secondary|Percentage of Participants With Improvement in PPBC|The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Improvement was defined as at least a 1-point improvement (decrease) from Baseline in PPBC score.|Baseline and Week 12|Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used.||percentage of participants|||Number
841014|NCT01340027|Secondary|Change From Baseline to End of Treatment in Patient Perception of Bladder Condition (PPBC)|The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems’; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. A negative change from Baseline score indicates improvement.|Baseline and Week 12|Full Analysis Set participants with available Baseline and post-baseline data; LOCF imputation was used||units on a scale||Standard Error|Least Squares Mean
841015|NCT01340027|Secondary|Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours|Nocturia is defined as waking at night one or more times to void. The average number of times a participant urinated (excluding incontinence only episodes) during sleeping time per day was derived from the 3-day micturition diary.|Baseline and Weeks 2, 4, 8 and 12|"Full analysis set participants who had at least one nocturia episode at baseline, and including participants with available data at Baseline and each post-baseline visit (indicated by n). LOCF was used for the End of Treatment (EOT) analysis."||nocturia episodes||Standard Error|Least Squares Mean
841016|NCT01340027|Secondary|Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours|The average number of times a participant recorded a new pad used per day during the 3-day micturition diary period.|Baseline and Weeks 2, 4, 8 and 12|"Full analysis set participants who had at least one use of pad at baseline, and including participants with available data at Baseline and each post-baseline visit (indicated by n). LOCF was used for the End of Treatment (EOT) analysis."||pads||Standard Error|Least Squares Mean
841017|NCT01340027|Secondary|Change From Baseline to Each Visit in Mean Level of Urgency|Average of participants’ ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in the 3-day micturition diary according to the Patient Perception of Intensity of Urgency Scale: 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet.|Baseline and Weeks 2, 4, 8 and 12|"Full analysis set including participants with available data at Baseline and each post-baseline visit (indicated by n). LOCF was used for the End of Treatment (EOT) analysis."||units on a scale||Standard Error|Least Squares Mean
841018|NCT01340027|Secondary|Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours|The average number of urgency episodes (the sudden, compelling desire to pass urine, which is difficult to defer), derived from urgency episodes classified by the participant in the 3-day micturition diary as grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet.|Baseline and Weeks 2, 4, 8 and 12|"Full analysis set including participants with available data at Baseline and each post-baseline visit (indicated by n). LOCF was used for the End of Treatment (EOT) analysis."||urgency episodes||Standard Error|Least Squares Mean
841019|NCT01340027|Secondary|Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours|Urgency incontinence is the involuntary leakage of urine accompanied by or immediately preceded by urgency, and was derived from the number of incontinence episodes classified by the participant in a 3-day micturition diary as Grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet.|Baseline and Weeks 2, 4, 8 and 12|"Full Analysis Set-Incontinence participants who had at least 1 urgency (grade 3 or 4) incontinence episode at Baseline, including participants with available data at Baseline and each post-baseline visit (indicated by n). LOCF was used for the End of Treatment (EOT) analysis."||urgency incontinence episodes||Standard Error|Least Squares Mean
841020|NCT01340027|Secondary|Percentage of Participants With 50% Reduction in Incontinence Episodes|The percentage of participants with at least a 50% decrease from Baseline in mean number of incontinence episodes per 24 hours during the 3 days prior to each clinic visit derived from the participant's micturition diary.|Baseline and Weeks 2, 4, 8 and 12|"Full Analysis Set-Incontinence including participants with available data at Baseline and each post-baseline visit (indicated by n); LOCF imputation was used for the End of Treatment (EOT) analysis."||percentage of participants|||Number
841021|NCT01340027|Secondary|Percentage of Participants With Zero Incontinence Episodes Post-baseline|The percentage of participants with no incontinence episodes for the 3 days prior to each clinic visit derived from the micturition diary recorded by the participant.|Weeks 2, 4, 8 and 12|"Full Analysis Set-Incontinence including participants with available data at Baseline and each post-baseline visit (indicated by n); LOCF imputation was used for the End of Treatment (EOT) analysis."||percentage of participants|||Number
841022|NCT01340027|Secondary|Change From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours|The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the participant in the micturition diary for 3-days before the Baseline and each post-baseline clinic visit.|Baseline and Weeks 2, 4, 8 and 12|"Full Analysis Set-Incontinence including participants with available data at Baseline and each post-baseline visit (indicated by n)."||incontinence episodes||Standard Error|Least Squares Mean
841023|NCT01340027|Secondary|Percentage of Participants With a Micturition Response|A responder is defined as a participant with at most 8 micturitions per 24 hours post-baseline and a negative change (i.e. an improvement) from Baseline.|Baseline and Weeks 2, 4, 8 and 12|"Full analysis set participants with at least 8 micturitions per 24 hours at Baseline and including participants with available data at Baseline and each post-baseline visit (indicated by n); LOCF imputation was used for the End of Treatment (EOT) analysis."||percentage of participants|||Number
841024|NCT01340027|Secondary|Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours|The average number of micturitions (urinations) per 24 hours was derived from the number of urinations (excluding incontinence only episodes) per day recorded by the participant in the micturition diary for 3-days before the Baseline and each post-baseline clinic visit.|Baseline and Weeks 2, 4, 8 and 12|"Full analysis set including participants with available data at Baseline and each post-baseline visit (indicated by n)."||micturitions||Standard Error|Least Squares Mean
841025|NCT01340027|Secondary|Change From Baseline to Each Visit in Mean Volume Voided Per Micturition|The average volume voided per micturition was calculated from the volume of each micturition measured by the participant and recorded in a micturition diary for 3 days before the Baseline and each post-baseline clinic visit.|Baseline and Weeks 2, 4, 8 and 12|"Full analysis set including participants with available data at Baseline and each post-baseline visit (indicated by n).."||mL||Standard Error|Least Squares Mean
841026|NCT01340027|Secondary|Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours|The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the participant in the micturition diary for 3-days before the Baseline and Week 12 clinic visits.|Baseline and Week 12|The Full Analysis Set-Incontinence comprised participants in the FAS who reported at least 1 incontinence episode in the baseline diary. LOCF was used.||incontinence episodes||Standard Error|Least Squares Mean
841027|NCT01340027|Secondary|Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours|The average number of micturitions (urinations) per 24 hours was derived from the number of urinations (excluding incontinence only episodes) per day recorded by the participant in the micturition diary for 3-days before the Baseline and Week 12 clinic visits.|Baseline and Week 12|Full analysis set; LOCF was used.||micturitions||Standard Error|Least Squares Mean
841041|NCT01340209|Secondary|Weekly Mean Number of Puffs of Rescue Medication During the Whole Day (Response)|Response of weekly mean number of puffs of rescue medication during the whole day at week 52. Response was defined as change from baseline.|baseline and week 52|Full analysis set||Puffs||Standard Deviation|Mean
841028|NCT01340027|Primary|Change From Baseline to End of Treatment (EOT) in Mean Volume Voided Per Micturition|The average volume voided per micturition was calculated from the volume of each micturition measured by the participant and recorded in a micturition diary for 3 days before the Baseline and Week 12 clinic visits.|Baseline and Week 12|The Full Analysis Set (FAS) comprised all participants took at least 1 dose of double-blind study medication after randomization and had primary efficacy data (mean volume voided) derived from the diary at Baseline and at least 1 post-baseline visit. Last observation carried forward imputation (LOCF) was utilized.||mL||Standard Error|Least Squares Mean
841029|NCT01340066|Primary|Percentage of Participants With a Decrease in Leakage Events of 30% or More.|Incontinence events were recorded on a daily diary. Leaks were scored and tabulated for a daily score. These values were utilized to come up with total of leakage events during the double-blind treatment period.|Change from baseline after 4 weeks of treatment.|||Percentage of participants|||Number
841030|NCT01340144|Primary|Evaluate for the Incidence of Patellar Crepitus Requiring Non-operative vs. Operative Treatment of Both the Study and Control Groups at a Minimum of 12 Months Following the TKA (Total Knee Arthroplasty) Procedure in Each Subject.|The incidence of patellar crepitus and clunk will be statistically compared between the study (PFC Sigma HP PS TKA) and control (PFC Sigma PS TKA groups). Based on a strength analysis to determine a theoretical reduction in the incidence of patellar crepitus from 5% to 2%, a study group of 625 subjects in both the control and study ggroups will be required. Each group will also be statistically analyzed using the following variables: overall crepitus incidence, incidence of crepitus requiring only non-operative treatment vs. those requiring operative treatment to manage this complication.|Two years after TKA (Total Knee Arthroplasty) procedure|||participants|||Number
841031|NCT01340196|Secondary|Clinical Relevant Abnormalities for Physical Examination, Vital Signs, Safety Laboratory Tests and 12-lead ECG|"Clinical relevant abnormalities for physical examination, vital signs, safety laboratory tests and 12-lead ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.
Preferred term of relevant AE: Presyncope"|From drug administration up to 32 days.|All subjects who were dispensed study medication and were documented to have taken at least one dose of study drug were included in the safety evaluation (treated set).||participants|||Number
841032|NCT01340196|Secondary|Number of Patients With Drug Related Adverse Events During the Trial|Outcome data are the numbers of subjects with investigator defined drug-related AEs|From drug administration up to 32 days.|All subjects who were dispensed study medication and were documented to have taken at least one dose of study drug were included in the safety evaluation (treated set).||participants|||Number
841033|NCT01340196|Primary|Steady-state Pharmacokinetics of C12hr of Faldaprevir on Day 15 and on Day 22|Measured concentration of the analyte in plasma at 12 h (C12hr) after dosing, at steady state.|168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00, 192:00 hours on day 15 and 144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00 hours on day 22|All participants from the pharmacokinetic analysis set (PK set), including all subjects in the treated set who provided evaluable data for at least 1 observation for at least 1 primary PK endpoint without important protocol violations relevant to the evaluation of PK.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
841034|NCT01340196|Primary|Steady-state Pharmacokinetics of Cmax of Faldaprevir on Day 15 and Day 22|Maximum measured concentration of analyte in plasma (Cmax), at steady state.|168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00, 192:00 hours on day 15 and 144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00 hours on day 22|All participants from the pharmacokinetic analysis set (PK set), including all subjects in the treated set who provided evaluable data for at least 1 observation for at least 1 primary PK endpoint without important protocol violations relevant to the evaluation of PK.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
841035|NCT01340196|Primary|Steady-state Pharmacokinetics of AUC0-12 of Faldaprevir on Day 15 and on Day 22|Area under the concentration-time curve (AUC) of the analyte in plasma over the time interval 0-12 hours, at steady state.|168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00, 192:00 hours on day 15 and 144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00 hours on day 22|All participants from the pharmacokinetic analysis set (PK set), including all subjects in the treated set who provided evaluable data for at least 1 observation for at least 1 primary PK endpoint without important protocol violations relevant to the evaluation of PK.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
841036|NCT01340196|Primary|Steady-state Pharmacokinetics of C24hr of Tenofovir on Day 7 and on Day 15|Measured concentration of the analyte in plasma at 24 h (C24hr) after dosing, at steady state.|144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00, 168:00 hours on day 7 and 168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00, 192:00 hours on day 15|All participants from the pharmacokinetic analysis set (PK set), including all subjects in the treated set who provided evaluable data for at least 1 observation for at least 1 primary PK endpoint without important protocol violations relevant to the evaluation of PK.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
841037|NCT01340196|Primary|Steady-state Pharmacokinetics of Cmax of Tenofovir on Day 7 and on Day 15|Maximum measured concentration of analyte in plasma (Cmax), at steady state.|144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00, 168:00 hours on day 7 and 168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00. 192:00 hours on day 15|All participants from the pharmacokinetic analysis set (PK set), including all subjects in the treated set who provided evaluable data for at least 1 observation for at least 1 primary PK endpoint without important protocol violations relevant to the evaluation of PK.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
841038|NCT01340196|Primary|Steady-state Pharmacokinetics of AUC0-24 of Tenofovir on Day 7 and on Day 15|Area under the concentration-time curve (AUC) of the analyte in plasma over the time interval 0-24 hours, at steady state.|144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00, 168:00 hours on day 7 and 168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00, 192:00 hours on day 15|All participants from the pharmacokinetic analysis set (PK set), including all subjects who were documented to have taken at least one dose of trial medication (treated set) who provided evaluable data for at least 1 observation for at least 1 primary PK endpoint without important protocol violations relevant to the evaluation of PK.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
841042|NCT01340209|Secondary|Weekly Mean PEF Variability Response|"Weekly mean PEF variability response was defined as change from baseline at week 52.
The PEF variability is the absolute difference between morning and evening PEF value, divided by their mean, expressed as a percent. Response was defined as change from baseline."|baseline and week 52|Full analysis set||percentage||Standard Error|Least Squares Mean
841043|NCT01340209|Secondary|Weekly Mean PEFpm Response|Weekly mean PEFpm response was defined as change from baseline at week 52|baseline and week 52|Full analysis set||L/min||Standard Error|Least Squares Mean
841044|NCT01340209|Secondary|Weekly Mean PEFam Response|Weekly mean PEFam response was defined as change from baseline at week 52|baseline and week 52|Full analysis set||L/min||Standard Error|Least Squares Mean
841045|NCT01340209|Secondary|Trough PEF Response|Trough PEF response was defined as change from baseline at week 52|baseline and week 52|Full analysis set||L/min||Standard Error|Least Squares Mean
841046|NCT01340209|Secondary|Trough FVC Response|Trough FVC response was defined as change from baseline at week 52|baseline and week 52|Full analysis set||Liter||Standard Error|Least Squares Mean
841047|NCT01340209|Secondary|Trough FEV1 Response|Trough FEV1 response was defined as change from baseline at week 52|baseline and week 52|Full analysis set: all patients of the treated set for which baseline and at least 1 post-baseline efficacy measurement were available||Liter||Standard Error|Least Squares Mean
841048|NCT01340209|Primary|Number of Patients With Drug-related Adverse Events|The primary endpoint is the number of patients with drug-related adverse events|after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409|Treated set: all randomised patients who received at least 1 dose of study medication||participants|||Number
841055|NCT01340573|Secondary|Participants' Overall Rating of Satisfaction and the Use of Training Materials for the Pegintron Pen, as Provided in a Study Questionnaire|Participants will complete a single questionnaire during the first follow-up visit (Week 12). The questionnaire will measure the participant's satisfaction and the use of training materials for the PegIntron Pen during the course of study therapy, as measured by the participant using a 1- 5 score system provided in the questionnaire.|Week 12|The study was terminated early due to low enrollment. This analysis was not performed.|||||
841056|NCT01340573|Secondary|Number of Genotype-1 Participants Who Have Achieved Sustained Virologic Response (SVR) at Week-24 Follow-up||Week-24 follow-up|The study was terminated early due to low enrollment. This analysis was not performed.|||||
841057|NCT01340573|Secondary|Number of Genotype-1 Participants Who Have Achieved Sustained Virologic Response (SVR) at Week-48 of Study Treatment||Week-48|The study was terminated early due to low enrollment. This analysis was not performed.|||||
841058|NCT01340573|Secondary|Number of Non-genotype-1 Participants Who Have Achieved Sustained Virologic Response (SVR) at Week-24 Follow-up||Week-24 follow-up|The study was terminated early due to low enrollment. This analysis was not performed.|||||
841059|NCT01340573|Secondary|Number of Non-genotype-1 Participants Who Have Achieved Sustained Virologic Response (SVR) at Week-24 of Study Treatment|Sustained virologic response (SVR) is the absence of detectable HCV RNA in serum after end of treatment.|Week-24|The study was terminated early due to low enrollment. This analysis was not performed.|||||
841060|NCT01340573|Primary|Number of Non-genotype 1 Participants Who Experienced Serious Adverse Events (SAE) on Week-24 Follow-up|Collection of all safety reports (serious adverse events) from Non-genotype-1 population at week-24 non-treatment follow-up, from participants on pegylated interferon (PegIntron) pen plus ribavirin.|Week-24 follow-up|The study was terminated early due to low enrollment. This analysis was not performed.|||||
841061|NCT01340573|Primary|Number of Non-genotype-1 Participants Who Experienced Serious Adverse Events (SAE) at Week-24 of Study Treatment|Collection of all safety reports (serious adverse events) from Non-genotype-1 population at week-24 of study treatment, from participants on pegylated interferon (PegIntron) pen plus ribavirin.|Week-24|The study was terminated early due to low enrollment. This analysis was not performed.|||||
841062|NCT01340573|Primary|Number of Genotype-1 Participants Who Experienced Serious Adverse Events (SAE) at Week-24 Follow-up|Collection of all safety reports (serious adverse events) from genotype-1 population at week-24 non-treatment follow-up, from participants on pegylated interferon (PegIntron) pen plus ribavirin.|Week-24 follow-up|The study was terminated early due to low enrollment. This analysis was not performed.|||||
841063|NCT01340573|Primary|Number of Genotype-1 Participants Who Experienced Serious Adverse Events (SAE) at Week-48 of Study Treatment|Collection of all safety reports (serious adverse events) from genotype-1 population at week-48 of treatment, from participants on pegylated interferon (PegIntron) pen plus ribavirin.|Week-48|The study was terminated early due to low enrollment. This analysis was not performed.|||||
841064|NCT01340586|Other Pre-specified|Number of Participants Who Died or Experienced Serious Adverse Events (SAEs) or Adverse Events Leading to Discontinuation|"The number of participants who died or experienced SAEs or AEs leading to discontinuation was reported for each arm.
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling."|From Day 1 to 30 days post study discontinuation|All treated participants||participants|||Number
841065|NCT01340586|Other Pre-specified|Number of Participants With Laboratory Marked Abnormalities|"ULN=Upper Limit of Normal, LLN=Lower Limit of Normal, Pre-Rx= Baseline value. BUN=Blood Urea Nitrogen (mmol/L=millimoles per Liter): High if BUN > 1.1*ULN (if Pre-Rx>ULN: >1.25*Pre-Rx).
Platelet count (*10^9 cell/L): Low if Platelet Count < 0.85*LLN (if Pre-Rx<LLN: <0.85*Pre-Rx).
Creatine (umol/L=micromoles per Liter): High if Creatine > 1.5*ULN (if Pre-Rx>ULN: >1.33*Pre-Rx).
Calcium, Total (mmol/L): High if Calcium > 1.5*ULN (if Pre-Rx>ULN: >1.33*Pre-Rx).
Potassium, serum (mmol/L): High if Potassium > 1.1*ULN (if Pre-Rx>ULN: >1.1*Pre-Rx; if Pre-Rx<LLN: >ULN).
Phosphorus, Inorganic (mmol/L): Low if Phosphate < 0.85*LLN (if Pre-Rx>ULN: <LLN).
Lactate dehydrogenase (U/L=Units per Liter): High if Lactate Dehydrogenase > 1.25*ULN (if Pre-Rx>ULN: >1.5*Pre-Rx)."|From 24 hours pre-dose to 72 hours post-dose|All treated participants||participants|||Number
841066|NCT01340586|Secondary|Mean Peak Anti-FXa Activity Following a Single Oral Dose of 5 mg Apixaban|Anti-FXa activity was assessed from an activity-time profile for doses both before and after hemodialysis. Maximal means were reported in International Units per milliliter (IU/mL).|From 24 hours pre-dose to 72 hours post-dose|All treated participants||IU/mL||Standard Deviation|Mean
841067|NCT01340586|Secondary|Mean Maximum Percent Change From Baseline Activated Partial Thromboplastin Time (aPTT) Following a Single Oral Dose of 5 mg Apixaban|The mean maximum percent change in Activated Partial Thromboplastin Time (aPTT) from baseline was reported for all treated participants. Baseline measurements were assessed up to 24 hours prior to Day 1 dosing.|From 24 hours pre-dose to 72 hours post-dose|All treated participants||maximum percent change from baseline||Standard Deviation|Mean
841068|NCT01340586|Secondary|Mean Maximum Percent Change From Baseline Prothrombin Time (PT) Following a Single 5 mg Oral Dose of Apixaban|The mean maximum percent change in Prothrombin Time (PT) from baseline was reported for all treated participants. Baseline measurements were assessed up to 24 hours prior to Day 1 dosing.|From 24 hours pre-dose to 72 hours post-dose|All treated participants||maximum percent change from baseline||Standard Deviation|Mean
841069|NCT01340586|Secondary|Mean Maximum Percent Change From Baseline International Normalized Ratio (INR) Following a Single 5 mg Oral Dose of Apixaban|The mean maximum percent change in baseline for INR was reported for each arm. Baseline measurements were assessed up to 24 hours prior to Day 1 dosing.|From 24 hours pre-dose to 72 hours post-dose|All treated participants||maximum percent change from baseline||Standard Deviation|Mean
841070|NCT01340586|Primary|Percentage of BMS-730823 Extracted During Hemodialysis|The percentage of BMS-730823 extracted during hemodialysis (extraction ratio) was calculated using the formula [plasma AUC(2-6)exiting - AUC(2-6)entering] / [AUC(2-6) entering] and converted to a percentage. The extraction ratio was measured in period 1 only, and was reported as a percentage.|2 to 6 hours post-dose|All treated participants with ESRD maintained with hemodialysis||percentage of BMS-730823 extracted||Standard Deviation|Mean
841071|NCT01340586|Primary|Percentage of Apixaban Extracted During Hemodialysis|The percentage of apixaban extracted during hemodialysis (extraction ratio) was calculated using the formula [plasma AUC(2-6) exiting - AUC(2-6) entering] / [AUC(2-6) entering] and converted to a percentage. The extraction ratio was measured in period 1 only, and was reported as a percentage.|2 to 6 hours post-dose|All treated participants with ESRD maintained with hemodialysis||percentage of apixaban extracted||Standard Deviation|Mean
841072|NCT01340586|Primary|Mean Hemodialysis Clearance (CLD) of BMS-730823|Hemodialysis clearance (CLD) was calculated by dividing the cumulative amount of BMS-730823 excreted in dialysate by the respective cumulative plasma AUC over the same dialysate collection interval (AUC(2-6) entering). CLD measurements occurred only in period 1. Geometric means were reported in milliliters per minute (mL/min).|2 to 6 hours post-dose|All participants with ESRD maintained with hemodialysis||mL/min||Standard Deviation|Mean
841073|NCT01340586|Primary|Mean Hemodialysis Clearance (CLD) of Apixaban|Hemodialysis clearance (CLD) was calculated by dividing the cumulative amount of apixaban excreted in dialysate by the respective cumulative plasma AUC over the same dialysate collection interval (AUC(2-6) entering). CLD measurements occurred only in period 1. Geometric means were reported in milliliters per minute (mL/min).|2 to 6 hours post-dose|All treated participants with ESRD maintained with hemodialysis||mL/min||Geometric Coefficient of Variation|Geometric Mean
841074|NCT01340586|Primary|Mean Renal Clearance (CLR) of BMS-730823|Renal clearance (CLR) was calculated by dividing the cumulative amount of BMS-730823 excreted in urine by the respective cumulative plasma AUC over the same urine collection interval. Geometric means were reported in milliliters per minute (mL/min).|24 hours pre-dose to 72 hours post-dose|All treated participants||mL/min||Geometric Coefficient of Variation|Geometric Mean
841075|NCT01340586|Primary|Mean Renal Clearance (CLR) of Apixaban|Renal clearance (CLR) was calculated by dividing the cumulative amount of apixaban excreted in urine by the respective cumulative plasma AUC over the same urine collection interval. Geometric means were reported in milliliters per minute (mL/min).|24 hours pre-dose to 72 hours post-dose|All treated participants||mL/min||Geometric Coefficient of Variation|Geometric Mean
841076|NCT01340586|Primary|Mean Percent Dose of Apixaban Recovered in Dialysate (%DR)|Percent dose of Apixaban recovered in dialysate (%DR) was calculated by dividing the cumulative amount of apixaban excreted in each dialysate collection over 2-6 hours (DR(2-6)) by the apixaban dose. %DR was recorded only in period 1.|2 to 6 hours post-dose|All treated participants with ESRD maintained with hemodialysis||percent of dose recovered in dialysate||Standard Deviation|Mean
841077|NCT01340586|Primary|Mean Percent Dose of Apixaban Recovered in Urine (%UR)|The percent dose recovered in urine was calculated by dividing the cumulative amount of unchanged apixaban excreted in urine from the time of dose up to 72 hours post-dose by the apixaban dose administered.|24 hours pre-dose to 72 hours post-dose|All treated participants||percent of dose recovered in urine||Standard Deviation|Mean
841078|NCT01340586|Primary|Geometric Mean of Area Under the Plasma Concentration-Time Curve From 2 to 6 Hours (AUC(2-6)) for BMS-730823|Area under the plasma concentration-time curve from 2 hours to 6 hours (AUC(2-6) for BMS-730823 was measured in participants with ESRD during dialysis in Period 1 only. Geometric Means were reported in nanogram hours per milliliter (ng*hr/mL) and were determined from blood samples both entering and exiting the dialyzer.|2 to 6 hours post-dose|All participants with ESRD maintained with hemodialysis||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
841079|NCT01340586|Primary|Geometric Mean of Area Under the Plasma Concentration-Time Curve From 2 to 6 Hours (AUC(2-6)) for Apixaban|Area under the plasma concentration-time curve from 2 hours to 6 hours (AUC(2-6) for Apixaban was measured in participants with ESRD during dialysis in Period 1 only. Geometric Means were reported in nanogram hours per milliliter (ng*hr/mL) and were determined from blood samples both entering and exiting the dialyzer.|2 to 6 hours post-dose|All participants with ESRD maintained with hemodialysis||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
841080|NCT01340586|Primary|Median Time of Maximum Observed Plasma Concentration (Tmax) of Metabolite BMS-730823|Time of maximum observed plasma concentration (Tmax) for BMS-730823 was derived from plasma concentrations versus time data. Medians were reported in hours.|From 24 hours pre-dose to 72 hours post-dose|All treated participants||hours||Full Range|Median
841081|NCT01340586|Primary|Median Time of Maximum Observed Plasma Concentration (Tmax) of a Single 5 mg Oral Dose of Apixaban|Time of maximum observed plasma concentration (Tmax) for apixaban was derived from plasma concentrations versus time data. Medians were reported in hours.|From 24 hours pre-dose to 72 hours post-dose|All treated participants||hours||Full Range|Median
841082|NCT01340586|Primary|Mean Plasma Terminal Half-life (T-Half) of BMS-730823|Mean plasma terminal half-life (T-Half) for BMS-730823 was derived from plasma concentrations versus time data.|24 hours pre-dose to 72 hours post-dose|All treated participants with ESRD maintained with hemodialysis||hours||Standard Deviation|Mean
841083|NCT01340586|Primary|Mean Plasma Terminal Half-life (T-Half) of Single 5mg Oral Dose of Apixaban|Plasma terminal half-life (T-Half) for apixaban was derived from plasma concentrations versus time data. Means were reported in hours.|From 24 hours pre-dose to 72 hours post-dose|All treated participants||hours||Standard Deviation|Mean
841084|NCT01340586|Primary|Geometric Mean of Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) of BMS-730823|The area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) was measured by plasma concentration of BMS-730823 over time. The geometric means are reported in nanogram hours per milliliter (ng*h/mL).|24 hours pre-dose to 72 hours post-dose|All treated participants||ng*h/mL||Standard Deviation|Mean
841085|NCT01340586|Primary|Geometric Mean of Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) of Single 5mg Oral Dose of Apixaban|The area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) was measured by plasma concentration of apixaban over time. The geometric means are reported in nanogram hours per milliliter (ng*h/mL).|From 24 hours pre-dose to 72 hours post-dose|All treated participants||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
841086|NCT01340586|Primary|Geometric Mean of Area Under the Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC(0-T)) of Metabolite BMS-730823|Area under the concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)) was measured by plasma concentration of BMS-730823 over time. The geometric means are reported in nanogram hours per milliliter (ng*h/mL).|From 24 hours pre-dose to 72 hours post-dose|All treated participants||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
841087|NCT01340586|Primary|Geometric Mean of Area Under the Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC(0-T)) of Single 5mg Oral Dose of Apixaban|Area under the concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)) was measured by plasma concentration of apixaban over time. The geometric means are reported in nanogram hours per milliliter (ng*h/mL).|24 hours pre-dose to 72 hours post-dose|All treated participants||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
841088|NCT01340586|Primary|Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Metabolite BMS-730823|Maximum observed plasma concentration (Cmax) was measured by plasma concentration of BMS-730823 over time. The geometric means are reported in nanograms per milliliter (ng/mL).|From 24 hours pre-dose to 72 hours post-dose|All treated participants||ng/mL||Geometric Coefficient of Variation|Geometric Mean
841089|NCT01340586|Primary|Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Single 5mg Oral Dose of Apixaban|Maximum observed plasma concentration (Cmax) was measured by plasma concentration of apixaban over time. The geometric means are reported in nanograms per milliliter (ng/mL).|24 hours pre-dose to 72 hours post-dose|All treated participants||ng/mL||Geometric Coefficient of Variation|Geometric Mean
841090|NCT01340625|Primary|AUC0-inf of Ethinyl Estradiol|Bioequivalence based on Ethinyl Estradiol AUC0-inf (area under the concentration-time curve from time zero to infinity).|Blood samples collected over a 60 hour period.|34 out of 36 subjects completed the study. Subjects 13 & 35 were excluded from the statistical analysis for Ethinyl Estradiol due to pre-dose concentrations greater than 5% of Cmax; therefore analysis included 32 data sets.||pg*h/mL||Standard Deviation|Mean
841091|NCT01340625|Primary|AUC0-t of Ethinyl Estradiol|Bioequivalence based on Ethinyl Estradiol AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).|Blood samples collected over a 60 hour period.|34 out of 36 subjects completed the study. Subjects 13 & 35 were excluded from the statistical analysis for Ethinyl Estradiol due to pre-dose concentrations greater than 5% of Cmax; therefore analysis included 32 data sets.||pg*h/mL||Standard Deviation|Mean
841092|NCT01340625|Primary|Cmax of Ethinyl Estradiol|Bioequivalence based on Ethinyl Estradiol Cmax (maximum observed concentration of drug substance in plasma).|Blood samples collected over a 60 hour period.|34 out of 36 subjects completed the study. Subjects 13 & 35 were excluded from the statistical analysis for Ethinyl Estradiol due to pre-dose concentrations greater than 5% of Cmax; therefore analysis included 32 data sets.||pg/mL||Standard Deviation|Mean
841093|NCT01340625|Primary|AUC0-inf of Norethindrone|Bioequivalence based on Norethindrone AUC0-inf (area under the concentration-time curve from time zero to infinity).|Blood samples collected over a 60 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
841094|NCT01340625|Primary|AUC0-t of Norethindrone|Bioequivalence based on Norethindrone AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).|Blood samples collected over a 60 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
841095|NCT01340625|Primary|Cmax of Norethindrone|Bioequivalence based on Norethindrone Cmax (maximum observed concentration of drug substance in plasma).|Blood samples collected over a 60 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
841096|NCT01340651|Secondary|Area Under the Plasma Concentration-time Curve (AUC) of Ruxolitinib 25 mg SR on Day 1|Blood samples were collected prior to and at 0.5, 1, 2, 3, 4, 6, and 9 hours after administration of ruxolitinib 25 mg SR on Day 1 of the study. The concentration of ruxolitinib was determined in plasma samples by a validated LC/MS/MS assay. The area under the plasma concentration-time curve (AUC) was derived from the plasma concentrations using a non-compartmental method and computed using the linear trapezoidal rule for increasing concentrations and the log-trapezoidal rule for decreasing concentrations with the software WinNonlin® version 6.0.0 (Pharsight Corporation, Mountain View, CA).|Day 1|Pharmacokinetic evaluable participants: All enrolled participants who received at least 1 dose of study medication and provided at least 1 plasma sample.||nM*h||Standard Deviation|Mean
841097|NCT01340651|Secondary|Time to Reach the Maximum Plasma Concentration (Tmax) of Ruxolitinib 25 mg SR on Day 1|Blood samples were collected prior to and at 0.5, 1, 2, 3, 4, 6, and 9 hours after administration of ruxolitinib 25 mg SR on Day 1 of the study. The concentration of ruxolitinib was determined in plasma samples by a validated LC/MS/MS assay. Standard noncompartmental pharmacokinetic methods were used to analyze the ruxolitinib plasma concentration data using WinNonlin® version 6.0.0 (Pharsight Corporation, Mountain View, CA). Tmax was taken directly from the observed plasma concentration data.|Day 1|Pharmacokinetic evaluable participants: All enrolled participants who received at least 1 dose of study medication and provided at least 1 plasma sample.||h||Full Range|Median
841098|NCT01340651|Secondary|Maximum Observed Plasma Concentration (Cmax) of Ruxolitinib 25 mg SR on Day 1|Blood samples were collected prior to and at 0.5, 1, 2, 3, 4, 6, and 9 hours after administration of ruxolitinib 25 mg SR on Day 1 of the study. The concentration of ruxolitinib was determined in plasma samples by a validated LC/MS/MS assay. Standard non-compartmental pharmacokinetic methods were used to analyze the ruxolitinib plasma concentration data using WinNonlin® version 6.0.0 (Pharsight Corporation, Mountain View, CA). Cmax was taken directly from the observed plasma concentration data.|Day 1|Pharmacokinetic evaluable participants: All enrolled participants who received at least 1 dose of study medication and provided at least 1 plasma sample.||nM||Standard Deviation|Mean
841099|NCT01340651|Secondary|Percentage of Participants With a ≥ 50% Reduction From Baseline in the Total Symptom Score at Week 16|Symptoms of myelofibrosis were assessed using the modified Myelofibrosis Symptom Assessment Form v2.0 diary that was to be completed by participants each night. The 7 symptoms (night sweats, itchiness, abdominal pain, pain under the ribs on left side, feeling of fullness [early satiety], bone/muscle pain, inactivity) were each rated on a scale from 0 (absent) to 10 (worst imaginable). The total symptom score was the sum of 6 of the 7 symptoms (inactivity was not included) and ranged from 0 to 60. A lower score indicated fewer symptoms.|Baseline to Week 16|Intent-to-treat population: All enrolled participants.||Percentage of participants||95% Confidence Interval|Number
841100|NCT01340651|Secondary|Change From Baseline in the Total Symptom Score at Week 16|Symptoms of myelofibrosis were assessed using the modified Myelofibrosis Symptom Assessment Form v2.0 diary that was to be completed by participants each night. The 7 symptoms (night sweats, itchiness, abdominal pain, pain under the ribs on left side, feeling of fullness [early satiety], bone/muscle pain, inactivity) were each rated on a scale from 0 (absent) to 10 (worst imaginable). The total symptom score was the sum of 6 of the 7 symptoms (inactivity was not included) and ranged from 0 to 60. A lower score indicated fewer symptoms. A negative change score indicated improvement.|Baseline to Week 16|Intent-to-treat population: All enrolled participants.||Percentage change||Standard Deviation|Mean
841101|NCT01340651|Secondary|Percentage of Participants With ≥ 35% Reduction in Spleen Volume at Week 16 From Baseline|Spleen volume was measured by magnetic resonance imaging (or by computed tomography [CT] in applicable participants). Scans were read by a central reader. Spleen volume was obtained by outlining the circumference of the organ and determining the volume using the validated technique of least squares.|Baseline to Week 16|Intent-to-treat population: All enrolled participants.||Percentage of participants||95% Confidence Interval|Number
841102|NCT01340651|Secondary|Change From Baseline in Spleen Length at Week 16|Spleen length was measured in centimeters by palpation.|Baseline to Week 16|Intent-to-treat population: All enrolled participants.||Percentage change||Standard Deviation|Mean
841103|NCT01340651|Secondary|Change From Baseline in Spleen Volume at Week 16|Spleen volume was measured by magnetic resonance imaging (or by computed tomography [CT] in applicable participants). Scans were read by a central reader. Spleen volume was obtained by outlining the circumference of the organ and determining the volume using the validated technique of least squares.|Baseline to Week 16|Intent-to-treat population: All enrolled participants.||Percentage change||Standard Deviation|Mean
841114|NCT01340794|Secondary|Overall Survival Time|Overall survival time is defined as the time from registration to death due to any cause and will be estimated using the Kaplan-Meier method.|The time from registration to death due to any cause, assessed up to 5 years|One of the two patients that initiated treatment with no run-in was found to be ineligible for this endpoint, leaving one patient evaluable for this endpoint in this treatment group. For patient confidentiality, results are not entered for endpoints based on 1 patient measures. All 4 patients that initiated treatment with a run-in were evaluable||months||95% Confidence Interval|Median
841104|NCT01340651|Primary|Overall Response (OR) at Week 16|The investigator graded OR according to the International Working Group for Myelofibrosis Research and Therapy criteria for treatment response. As bone marrow biopsies were not taken after baseline, the best achievable response was clinical improvement which required 1 of the following in the absence of progressive disease (PD): (1) A ≥ 2 g/dL increase in hemoglobin level or (2) either a palpable ≥ 50% reduction of splenomegaly of a spleen ≥ 10 cm at baseline or a spleen palpable at > 5 cm at baseline becoming not palpable. PD required 1 of the following: (1) Progressive splenomegaly defined by the appearance of previously absent splenomegaly that was palpable at > 5 cm below the left costal margin or a ≥ 100% increase in palpable distance for baseline splenomegaly of 5-10 cm or a ≥ 50% increase in palpable distance for baseline splenomegaly of > 10 cm or (2) an increase in peripheral blood blast percentage to ≥ 20% that lasted for ≥ 8 weeks. Stable disease: None of the above.|Baseline to Week 16|Intent-to-treat population: All enrolled participants.||Percentage of participants|||Number
841105|NCT01340651|Primary|Percentage of Participants With at Least 1 Adverse Event From Baseline Through Week 16||Baseline to Week 16|Safety population: All enrolled participants who took at least 1 dose of study drug.||Percentage of participants|||Number
841106|NCT01340664|Secondary|Percentage of Patients With HbA1c <7% at Week 18|The table below shows the percentage of patients with HbA1c <7% at Week 18 in each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage.|Week 18|This analysis used the modified intent-to-treat analysis set (all patients who were randomly assigned to a treatment group and received at least 1 dose of study drug). The last-observation-carried-forward method was applied when Week 18 values were missing. The table includes only patients with both baseline and post baseline values.||Percentage of Participants|||Number
841107|NCT01340664|Secondary|Percent Change in Body Weight From Baseline to Week 18|The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 18 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.|Day 1 (Baseline) and Week 18|This analysis used the modified intent-to-treat analysis set (all patients who were randomly assigned to a treatment group and received at least 1 dose of study drug). The last-observation-carried-forward method was applied when Week 18 values were missing. The table includes only patients with both baseline and post baseline values.||Percent change||Standard Error|Least Squares Mean
841108|NCT01340664|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 18|The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 18 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 18|This analysis used the modified intent-to-treat analysis set (all patients who were randomly assigned to a treatment group and received at least 1 dose of study drug). The last-observation-carried-forward method was applied when Week 18 values were missing. The table includes only patients with both baseline and post baseline values.||mg/dL||Standard Error|Least Squares Mean
841109|NCT01340664|Primary|Change in HbA1c From Baseline to Week 18|The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 18 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 18|This analysis used the modified intent-to-treat analysis set (all patients who were randomly assigned to a treatment group and received at least 1 dose of study drug). The last-observation-carried-forward method was applied when Week 18 values were missing. The table includes only patients with both baseline and post baseline values.||Percent||Standard Error|Least Squares Mean
841110|NCT01340768|Secondary|Percentage of Participants With at Least One Symptomatic or Asymptomatic Hypoglycemic Event|Symptomatic hypoglycemic events were based on the participants own self-reported symptoms (for example but not limited to the following: faintness, headache, confusion, anxiety, sweating, tremor, palpitations, nausea, pallor, dizziness, hunger, sudden behavioral change). Asymptomatic hypoglycemic events were based on self-monitored finger-stick blood glucose level.|Up to 30 days (Day 1 through last day of Ramadan)|All participants as treated population defined as all randomized participants who received at least one dose of study drug.||percentage of participants|||Number
841111|NCT01340768|Primary|Percentage of Participants With at Least One Symptomatic Hypoglycemic Event|Symptomatic hypoglycemic events were based on the participants own self-reported symptoms (for example, but not limited to the following: faintness, headache, confusion, anxiety, sweating, tremor, palpitations, nausea, pallor, dizziness, hunger, sudden behavioral change).|Up to 30 days (Day 1 through last day of Ramadan)|All participants as treated population defined as all randomized participants who received at least one dose of study drug.||percentage of participants|||Number
841112|NCT01340794|Secondary|Time to Treatment Failure|The time from the date of registration to the date at which the patient is removed from treatment due to progression, toxicity, or refusal, assessed up to 5 years.|Up to 5 years from registration|One of the two patients that initiated treatment with no run-in was found to be ineligible for this endpoint, leaving one patient evaluable for this endpoint in this treatment group. For patient confidentiality, results are not entered for endpoints based on 1 patient measures. All 4 patients that initiated treatment with a run-in were evaluable.||months||95% Confidence Interval|Median
841113|NCT01340794|Secondary|Progression-free Survival Time|Progression-free survival is defined as the time from registration to documentation of disease progression. If a patient dies without a documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death. Progression-free survival time will be estimated using the Kaplan-Meier method.|The time from registration to documentation of disease progression or death, whichever occurs first, assessed up to 5 years|One of the two patients that initiated treatment with no run-in was found to be ineligible for this endpoint, leaving one patient evaluable for this endpoint in this treatment group. For patient confidentiality, results are not entered for endpoints based on 1 patient measures. All 4 patients that initiated treatment with a run-in were evaluable||months||95% Confidence Interval|Median
841169|NCT01341782|Secondary|Percentage of Participants With Target Intact Parathyroid Hormone (iPTH)|The target iPTH range was 60-180 pg/mL, based on the average of the last 3 weeks of treatment. iPTH was measured before the first dialysis session of each week and analyzed by the central laboratory.|The last three weeks of treatment (Weeks 11, 12, and 13)|Full analysis set||percentage of participants||95% Confidence Interval|Number
841115|NCT01340794|Secondary|Duration of Tumor Response|Defined for all patients whose tumor met the criteria of CR or PR (using the RECIST criteria) as the date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented.|Up to 5 years|One of the two patients that initiated treatment with no run-in was found to be ineligible for this endpoint, leaving one patient evaluable for this endpoint in this treatment group. For patient confidentiality, results are not entered for endpoints based on 1 patient measures. None of the 4 patients that initiated treatment with a run-in responded|||||
841116|NCT01340794|Primary|Response Rate (RR) (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.1|"Response and progression are evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1) Ninety-five percent confidence intervals for the true response proportion was calculated using the exact binomial test.
Complete Response (CR): All of the following must be true:
Disappearance of all target and non-target lesions.
Each lymph node must have reduction in short axis to <1.0 cm.
Partial Response (PR):
At least a 30% decrease in PBSD (sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes at current evaluation) taking baseline measures as reference.
Overall Response (OR) was calculated by summing the number of patients with a CR or PR."|Up to 5 years|One of the two patients that initiated treatment with no run-in was found to be ineligible for this endpoint, leaving one patient evaluable for this endpoint in this treatment group. For patient confidentiality, results are not entered for endpoints based on 1 patient measures. All 4 patients that initiated treatment with a run-in were evaluable||percentage of participants||95% Confidence Interval|Number
841117|NCT01340937|Secondary|Percentage of Participants With Elevated Temperature by Severity|Maximum temperature (all routes) was based on actual temperatures recorded with no adjustments to the measurement route. Maximum temperature (rectal) was required of all participants if the reading by another method was >=38.0°C.|Up to 5 days after any infant vaccination (up to 6 months)|Participants included in this analyses were All Subjects as Treated population defined as all vaccinated participants with safety follow up and temperature data. This outcome applied only to V419 Lots A, B, and C Combined and Control; therefore, data for the individual V419 lots are not reported.||Percentage of participants|||Number
841118|NCT01340937|Secondary|Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions|Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3 Solicited injection site reaction: Pain, Cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, >5 cm. Grade 3 Solicited systemic reactions: Fever (Pyrexia), >=39.5°C rectal; Vomiting, >=6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, >3 hours; Drowsiness (Somnolence), Sleeping most of the time or difficult to wake up; Appetite lost, Refuses >=3 feeds or refuses most feeds; Irritability, Inconsolable.|Up to 5 days after any infant vaccination (up to 6 months)|Participants included in these analyses were All Subjects as Treated population and were defined as all vaccinated participants with safety follow up. This outcome applied only to V419 Lots A, B, and C Combined and Control; therefore, data for the individual V419 lots are not reported.||Percentage of participants|||Number
841119|NCT01340937|Secondary|Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes|Participant serum samples were collected for testing with a multiplex electrochemiluminescence-based detection assay for serotype-specific pneumococcal polysaccharide antibodies. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||µg/mL||95% Confidence Interval|Geometric Mean
841120|NCT01340937|Secondary|Percentage of Participants Responding to Pertussis Fimbriae|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae. Response was defined as follows: 1) if the predose titer was <4X LLOQ then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.|Postdose 4 (Month 16)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.||Percentage of participants||95% Confidence Interval|Number
841121|NCT01340937|Secondary|Percentage of Participants Responding to Pertussis Pertactin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin. Response was defined as follows: 1) if the predose titer was <4X LLOQ then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.|Postdose 4 (Month 16)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.||Percentage of participants||95% Confidence Interval|Number
841122|NCT01340937|Secondary|Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin. Response was defined as follows: 1) if the predose titer was <4X LLOQ then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.|Postdose 4 (Month 16)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.||Percentage of participants||95% Confidence Interval|Number
841147|NCT01340937|Primary|Geometric Mean Concentration of Antibodies to Hepatitis B Surface Antigen|Participant serum samples were collected for testing with an enhanced chemiluminescence assay for antibodies to Hepatitis B Surface Antigen. The unit of measure is milli International Units/mL (mIU/mL).|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||mIU/mL||95% Confidence Interval|Geometric Mean
841123|NCT01340937|Secondary|Percentage of Participants Responding to Pertussis Toxin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin. Response was defined as follows: 1) if the predose titer was <4X LLOQ then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.|Postdose 4 (Month 16)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.||Percentage of participants||95% Confidence Interval|Number
841124|NCT01340937|Secondary|Geometric Mean Concentration of Antibodies to Pertussis Fimbriae|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.|Postdose 4 (Month 16)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.||EU/mL||95% Confidence Interval|Geometric Mean
841125|NCT01340937|Secondary|Geometric Mean Concentration of Antibodies to Pertussis Pertactin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.|Postdose 4 (Month 16)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.||EU/mL||95% Confidence Interval|Geometric Mean
841126|NCT01340937|Secondary|Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.|Postdose 4 (Month 16)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.||EU/mL||95% Confidence Interval|Geometric Mean
841127|NCT01340937|Secondary|Geometric Mean Concentration of Antibodies to Pertussis Toxin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.|Postdose 4 (Month 16)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.||EU/mL||95% Confidence Interval|Geometric Mean
841128|NCT01340937|Secondary|Percentage of Participants Responding to Poliovirus Type 3|Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 3. Response is defined as a titer >=8.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||Percentage of participants||95% Confidence Interval|Number
841129|NCT01340937|Secondary|Percentage of Participants Responding to Poliovirus Type 2|Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 2. Response is defined as a titer >=8.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||Percentage of participants||95% Confidence Interval|Number
841130|NCT01340937|Secondary|Percentage of Participants Responding to Poliovirus Type 1|Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 1. Response is defined as a titer >=8.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||Percentage of participants||95% Confidence Interval|Number
841131|NCT01340937|Secondary|Percentage of Participants Responding to Pertussis Fimbriae|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae. Response was defined as follows: 1) if the predose titer was <4X LLOQ then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||Percentage of participants||95% Confidence Interval|Number
841132|NCT01340937|Secondary|Percentage of Participants Responding to Pertussis Pertactin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin. Response was defined as follows: 1) if the predose titer was <4X LLOQ then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||Percentage of participants||95% Confidence Interval|Number
841133|NCT01340937|Secondary|Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin. Response was defined as follows: 1) if the predose titer was <4X LLOQ then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||Percentage of participants||95% Confidence Interval|Number
841134|NCT01340937|Secondary|Percentage of Participants Responding to Pertussis Toxin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin. Response was defined as follows: 1) if the predose titer was <4 times the lower limit of quantitation (4X LLOQ) then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||Percentage of participants||95% Confidence Interval|Number
841135|NCT01340937|Secondary|Percentage of Participants Responding to Tetanus Toxin|Participant serum samples were collected for testing with an ELISA for anti-tetanus antibodies. Response was defined as a titer >=0.1 IU/mL.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||Percentage of participants||95% Confidence Interval|Number
841136|NCT01340937|Secondary|Percentage of Participants Responding to Diphtheria Toxin|Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to diphtheria toxin. Response was defined as a titer >=0.1 IU/mL.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||Percentage of participants||95% Confidence Interval|Number
841137|NCT01340937|Secondary|Percentage of Participants Responding to Hepatitis B Surface Antigen|Participant serum samples were collected for testing with an enhanced chemiluminescence assay for antibodies to Hepatitis B Surface Antigen. Response was defined as a titer >=10 mIU/mL.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||Percentage of participants||95% Confidence Interval|Number
841138|NCT01340937|Primary|Geometric Mean Titer for Antibodies to Poliovirus Type 3|Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 3.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||Titer||95% Confidence Interval|Geometric Mean
841139|NCT01340937|Primary|Geometric Mean Titer for Antibodies to Poliovirus Type 2|Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 2.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||Titer||95% Confidence Interval|Geometric Mean
841140|NCT01340937|Primary|Geometric Mean Titer for Antibodies to Poliovirus Type 1|Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 1. The unit of measure is titer (reciprocal of highest dilution with neutralizing activity).|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||Titer||95% Confidence Interval|Geometric Mean
841141|NCT01340937|Primary|Geometric Mean Concentration of Antibodies to Pertussis Fimbriae|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||EU/mL||95% Confidence Interval|Geometric Mean
841142|NCT01340937|Primary|Geometric Mean Concentration of Antibodies to Pertussis Pertactin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||EU/mL||95% Confidence Interval|Geometric Mean
841143|NCT01340937|Primary|Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||EU/mL||95% Confidence Interval|Geometric Mean
841144|NCT01340937|Primary|Geometric Mean Concentration of Antibodies to Pertussis Toxin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin. The unit of measure is ELISA units/mL (EU/mL).|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||EU/mL||95% Confidence Interval|Geometric Mean
841145|NCT01340937|Primary|Geometric Mean Concentration of Antibodies to Tetanus Toxin|Participant serum samples were collected for testing with an Enzyme-linked Immunosorbent Assay (ELISA) for anti-tetanus antibodies.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||IU/mL||95% Confidence Interval|Geometric Mean
841146|NCT01340937|Primary|Geometric Mean Concentration of Antibodies to Diphtheria Toxin|Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to diphtheria toxin. The unit of measure is International Units/mL (IU/mL).|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||IU/mL||95% Confidence Interval|Geometric Mean
841148|NCT01340937|Secondary|Percentage of Participants Responding to Polyribosylribitol Phosphate Antigen|Participant serum samples were collected for testing with a radioimmunoassay for antibodies to Haemophilus influenza type b capsular polysaccharide polyribosylribitol phosphate. Response was evaluated for a titer >=0.15 µg/mL and >=1.0 µg/mL.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||Percentage of participants||95% Confidence Interval|Number
841149|NCT01340937|Primary|Geometric Mean Concentration of Antibodies to Polyribosylribitol Phosphate Antigen|Participant serum samples were collected for testing with a radioimmunoassay for antibodies to Haemophilus influenza type b capsular polysaccharide polyribosylribitol phosphate.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||µg/mL||95% Confidence Interval|Geometric Mean
841150|NCT01341067|Secondary|Change in Basal Insulin Dose From Baseline Values||Assessed at baseline and 6 months|||units of insulin||Standard Deviation|Mean
841151|NCT01341067|Secondary|Change in Percentage of Time Spent at Glycemic Levels >180 mg/dl||Measured at baseline and 6 months|||percentage of time spent >180 mg/dl||Standard Deviation|Mean
841152|NCT01341067|Secondary|Percentage of Time Spent at Glycemic Levels <65 mg/dl||Measured at baseline and at 6 months|||percentage of time spent < 65 mg/dl||Standard Deviation|Mean
841153|NCT01341067|Primary|Change in HgbA1c||Measured at 6 months|||percentage of glycosylated hemoglobin||Standard Deviation|Mean
841154|NCT01341444|Primary|Number of Participants With Surgical Site Complications (SSCs)|The primary objective to compare short-term surgical incision-related clinical outcomes in Subjects undergoing open renal transplant surgery when treated with Prevena vs. the standard-of-care wound dressing. Clinical outcomes of interest are defined as Surgical Site Complications (SSCs) that include incisional fluid accumulation (i.e. seroma, hematoma, abscess), dehiscence, surgical site infection (SSI). These outcomes will be compared to a control group consisting of subjects screened for the same inclusion/exclusion criteria but treated with standard-of-care incision dressing.|62 Days|Analysis of this endpoint was based on the Full analysis Set (FAS population). The FAS population consists of participants who met all of the pre- and intra-operative eligibility criteria, were randomized and received treatment. Subjects without SSC must have received 5 days of Prevena or at least 3 days of SOC dressing and completed 30 day visit.||Participants|||Count of Participants
841155|NCT01341600|Primary|Change in Platelet Aggregation Following Therapy With Clopidogrel|ADP mediated platelet aggregation measured 4 hours post Day 8 clopidogrel dose|4 hours post Day 8 dose|||percentage of aggregation||Standard Deviation|Mean
841156|NCT01341600|Secondary|Level of Active Clopidogrel Metabolite|The level of the active clopidogrel metabolite will be measured at at 0.25, 0.5, 1, 2, and 4 hours after the Day One dose is administered for pharmacokinetic analysis. The analysis will measure the Area Under the Curve.|Baseline, 0.25, 0.5, 1, 2, and 4 hours|||ng h/mL||Standard Deviation|Mean
841157|NCT01341600|Secondary|Change in Platelet Aggregation Following Therapy With Clopidogrel and Omeprazole|The change in maximum platelet aggregation in response to ADP 4-hours post dose on day 8 of therapy with clopidogrel and omeprazole will be compared to the baseline measure of platelet aggregation at day 1 prior to drug therapy|Baseline, Day 8|||percentage of aggregation||Standard Deviation|Mean
841158|NCT01341600|Primary|Change in Platelet Aggregation Following Therapy With Clopidogrel|Adenosine diphosphate (ADP) mediated platelet aggregation measured 4 hours post-dose of clopidogrel on Day 1.|Day 1, 4 hours post clopidogrel dose|||percentage of aggregation||Standard Deviation|Mean
841159|NCT01335867|Secondary|Depression and Anxiety|Measures of depression and anxiety will be assessed using the Hamilton Depression Rating Scale and Hamilton Anxiety Rating Scale|8 weeks||||||
841160|NCT01335867|Secondary|Alcohol and Cocaine Withdrawal Severity|Measures of alcohol and cocaine withdrawal severity will include Clinical Institutes Withdrawal Scale for Alcohol and Cocaine Selective Severity Assessment|8 weeks||||||
841161|NCT01335867|Secondary|Disease Severity and Improvement|Measures of disease severity and improvement will include the Clinical Global Impression Scale|8 weeks||||||
841162|NCT01335867|Secondary|Addiction Severity|Measures of addiction severity will include the Addiction Severity Index (ASI)|8 weeks||||||
841163|NCT01335867|Secondary|Measures of Cocaine and Alcohol Craving|Measures of cocaine and alcohol craving will be measured using the Minnesota Cocaine Craving Scale and the Penn Alcohol Craving Scale|8 weeks||||||
841164|NCT01335867|Primary|More Alcohol Abstinent Days and Fewer Heavy Drinking Days|The primary outcome measure for reduction in alcohol use will be recorded using the Timeline Followback method.|8 weeks|||Days Heavy Drinking|||Number
841165|NCT01335867|Primary|Number of Participants With a Reduction in Cocaine Use|The primary outcome measure for reduction in cocaine use will be the number of benzoylecgonine (BE) negative urine samples.|3 weeks|||participants|||Number
841166|NCT01341782|Secondary|Number of Visits at Which Participants Achieved iPTH Control in the Target Range of 60 to 180 pg/mL|iPTH control was defined as being within the target range of 60 to 180 pg/mL. iPTH was measured before the first dialysis session of the week, once a week during the treatment phase and analyzed by the central laboratory.|Weeks 2 to 13|Full analysis set||visits||Standard Deviation|Mean
841167|NCT01341782|Secondary|Number of Visits at Which Participants Achieved iPTH Control With ≥ 50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline|iPTH control was defined as a ≥ 50% reduction from baseline. iPTH was measured before the first dialysis session of the week, each week during the treatment phase and analyzed by the central laboratory.|Weeks 2 to 13|Full analysis set||visits||Standard Deviation|Mean
841168|NCT01341782|Secondary|Percentage of Participants With ≥ 50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline|The percentage of participants with a greater than or equal to 50% reduction in intact parathyroid hormone (iPTH) from baseline to the average of the last 3 weeks of treatment. iPTH was measured before the first dialysis session of each week and analyzed by the central laboratory.|Baseline to the last three weeks of treatment (Weeks 11, 12, and 13)|Full analysis set||percentage of participants||95% Confidence Interval|Number
841170|NCT01341782|Secondary|Percentage of Participants With ≥ 50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline and With No Hypercalcemia|The percentage of participants with greater than or equal to 50% reduction in intact parathyroid hormone (iPTH) from baseline to the average of the last 3 weeks of treatment and with no hypercalcemia during the treatment phase. iPTH was measured before the first dialysis session of each week and analyzed by the central laboratory. Hypercalcemia was defined as at least 1 corrected calcium value > 11.0 mg/dL or at least 2 corrected calcium values ≥ 10.5 mg/dL.|Baseline to the last three weeks of treatment (Weeks 11, 12, and 13) for iPTH. Calcium measured throughout the study (Weeks 1-13).|The Full Analysis Set (FAS) consists of all randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline iPTH measurement.||percentage of participants||95% Confidence Interval|Number
841171|NCT01341782|Primary|Percentage of Participants With Target Intact Parathyroid Hormone (iPTH) and Without Hypercalcemia|The target iPTH range was 60-180 pg/mL, based on the average of the last 3 weeks of treatment, and with no hypercalcemia during the treatment phase. Hypercalcemia was defined as at least 1 corrected calcium value > 11.0 mg/dL or at least 2 corrected calcium values ≥ 10.5 mg/dL. iPTH was measured before the first dialysis session of each week and analyzed by the central laboratory.|iPTH measured during the last three weeks of treatment (Weeks 11, 12, and 13). Calcium measured throughout the study (Weeks 1-13).|The per-protocol set (PPS) consists of all randomized patients who completed at least 8 weeks of treatment and met the conditions specified by the subject classification (i.e., no violation of inclusion/exclusion criteria) that occurred before the study blind was broken.||percentage of participants||95% Confidence Interval|Number
841172|NCT01341912|Secondary|To Determine Long-term Efficacy of Human-cl rhFVIII in the Treatment of Bleeding Episodes and in Surgical Prophylaxis|"The efficacy of human-cl rhFVIII will be determined using a 4 point efficacy assessment scale.
After each infusion of IMP and at the end of a BE, the following efficacy assessment is made by the subject (together with the Investigator in case of on-site treatment):
Excellent: Abrupt pain relief and/or unequivocal improvement in objective signs of bleeding within approximately 8 hours after a single infusion.
Good: Definite pain relief and/or improvement in signs of bleeding within approximately 8 - 12 hours after an infusion requiring up to 2 infusions for complete resolution.
Moderate: Probable or slight beneficial effect within approximately 12 hours after the first infusion requiring more than two infusions for complete resolution.
None: No improvement within 12 hours, or worsening of symptoms, requiring more than 2 infusions for complete resolution.
The assessment was made at the end of a BE in case more than one infusion was needed."|up to 3 years|||percentage of bleeding episodes|Participants||Number
841173|NCT01341912|Primary|Long-term Immunogenicity|Patients will be monitored for inhibitors against FVIII every 3 months. Blood samples were drawn and inhibitor activity was determined by the modified Bethesda assay (Nijmegen modification) in the central lab.|up to 3 years|||occurrence of inhibitors|||Number
841174|NCT01341977|Primary|Subjective Acceptance|Lens Moisture Subject Rated Likert Item (1-Strongly Agree to 5-Strongly Disagree)|Day 90|||Subjective Rating||Standard Deviation|Mean
841175|NCT01341977|Primary|Subjective Acceptance|Lens Moisture Subject Rated Likert item|Day 90||||||
841176|NCT01342094|Primary|Change From Baseline in Mean Diurnal IOP (Intraocular Pressure) at End of Study|Mean diurnal IOP (intraocular pressure) was calculated as an average of IOP (intraocular pressure) at 9:30 (pre-dose), 11:30 and 17:30.|Week 0(Baseline) and Week 4(End of Study)|||mmHg||Standard Deviation|Mean
841177|NCT01342107|Primary|Lens Wettability|As assessed by the investigator during slit-lamp exam and rated on a 0-4 scale, with 0 = a smooth uniformly reflecting wettable surface; 1 = a coarse hazy wettable surface which seems resolved momentarily with each blink and becomes exacerbated with staring; 2 = one stable dry (non-wetting) area of some magnitude; 3 = more than one stable dry (non-wetting) area of some magnitude; 4 = non-wettable lens surface of severe magnitude. Lenses with a Grade 0 or 1 were rated as wettable and reported as a percentage of total lenses evaluated.|16 hours|Intent to treat. All subject-eyes that received contact lenses pre-soaked per treatment regimen and completed Visit 2 (Day 1 - Exit at 16 hours) were included in the ITT data set.||percentage of lenses||95% Confidence Interval|Number
841178|NCT01342172|Secondary|To Determine the Impact of Treatment on Circulating Tumor Cells|Circulating epithelial tumor cells (CTC) will be investigated as an experimental endpoint using immunofluorescence techniques and CTC identification by positive expression of epithelial markers and a viability marker and negative expression of hematopoietic markers. These analyses will only be done in the phase II portion of the protocol.|Day 1 of Cycles 0, 1 and 2 (each Cycle is 21 days)||||||
841179|NCT01342172|Secondary|To Determine the Impact of Treatment on Peripheral Blood Immune Cell Subsets|We plan to determine the changes in cellular immunity with lenalidomide in peripheral blood mononuclear cells including Tregs, NK, NKT cells (Berg et al JCO 2010), sIl-2R, TNF alpha (Bartlett et al BJC 2004) and markers indicative of activation, i.e. CD107a. These analyses will only be done in the phase II portion of the protocol.|Day 1 of Cycle 0 and Day 1 of Cycle 2 (each Cycle is 21 days)||||||
841180|NCT01342172|Secondary|To Evaluate Lenalidomide as Maintenance Treatment in Patients Achieving an Objective Response or Stable Disease Following Completion of 6 Cycles of Combination Therapy.||168 days||||||
841181|NCT01342172|Secondary|To Determine the Safety of Combination Therapy With Gemcitabine, Cisplatin, and Lenalidomide|The safety of combination therapy with gemcitabine, cisplatin plus lenalidomide as determined by the frequency and severity of adverse events as per the NCI Common Terminology for Adverse Events (CTCAE) version 4.0.|Day 1 and Day 8 of each treatment cycle; 21 days after the last dose of Lenalidomide||||||
841182|NCT01342172|Secondary|To Determine the Objective Response Rate to Treatment With Gemcitabine, Cisplatin, Plus Lenalidomide|The objective response rate as determined by Response Evaluation Criteria in Solid Tumors (RECIST). Restaging CT scans will be performed after every 2 cycles (after cycles 2, 4, and 6). Each cycle is 21 days.|After every 2 cycles (a cycle is 21 days)||||||
841183|NCT01342172|Primary|Phase II: Progression-free Survival at 1 Year||1 year||||||
841184|NCT01342172|Primary|Phase I: To Determine the Recommended Phase II Dose of the Combination of Gemcitabine, Cisplatin, Plus Lenalidomide|Safety as measured by the frequency and type of adverse event as per the NCI Common Terminology for Adverse Events (CTCAE) version 4 on Day 1 of each cycle (Cycle is 21 days).|Day 1 of each 21 day cycle|The dose of lenalidomide was not escalated beyond 10 mg because of cytopenias requiring repeated dose delays and reductions.|||||
841185|NCT01342341|Primary|Alcohol Consumption in Drinks/Week.|Each subject will record how many drinks/week they are consuming while on the study drug and placebo during the 45-day study. The primary outcome of this study is to determine the effect of chlorzoxazone on alcohol consumption. Reduction in alcohol consumption is measured utilizing behavioral inventories, electronic diaries, urine, and ethyl glucuronide.|45 days|||number of drinks||Standard Deviation|Mean
841186|NCT01342445|Primary|Behavior Rating Inventory of Executive Function - Adult (BRIEF-A)|BRIEF-A is a standardized self-report measure that captures adults’ views of their own self-regulation in their everyday environment. Metacognition Index T-scores (mean = 50; standard deviation = 10) were used as dependent measures with higher scores representing greater deficit in planning/organizational skills critical for college success.|after receiving Placebo or LDX for 1 week|||T score||Standard Deviation|Mean
841187|NCT01342445|Primary|Conners Adult ADHD Rating Scale - Short Version (CAARS)|CAARS ADHD Index, adult self-report measure of ADHD symptoms. T-scores (mean = 50; standard deviation = 10) for all subscales on the short version were used as dependent measures with higher scores representing greater ADHD symptomatology (and ultimately a worse outcome in this study).|after receiving Placebo or LDX for 1 week|||T score||Standard Deviation|Mean
841188|NCT01342458|Secondary|Paracetamol Intake|Paracetamol intake (500 mg), number of tablets per month.|6 month|||tablets per month||Inter-Quartile Range|Median
841189|NCT01342458|Secondary|First Peak of the Knee Adduction Moment (KAM) During Gait.|The first peak of the external knee moment was calculated by mean inverse dynamics approach. To this procedure, we used the kinematics data of the lower limbs assessed with six infrared cameras and the ground reaction force evaluated by mean a force platform. This is a continuous measure.|6 month|||% body weight x height in centimeters||Standard Deviation|Mean
841190|NCT01342458|Secondary|Six-minute Walk Test|The six-minute walk test assesses distance in meters walked over 6 minutes.|6 month|||meter||Standard Deviation|Mean
841191|NCT01342458|Secondary|Global Score of the Lequesne´s Questionaire Algo-functional.|This questionaire consists of three sections (eleven questions): about pain or discomfort, the maximum distance that the patient can walk, and activities of daily living. Scores range from zero to twenty-four, meaning cases without involvement and with extremely severe impairment, respectively.|6 month|||score||Standard Deviation|Mean
841192|NCT01342458|Secondary|WOMAC Total Score|The WOMAC total score is the sum of all subscale (pain, function and stiffness) (Likert Scale) relating to the patient's physical activities, or skills to move out and take care of themselves. The Likert Scale version used for all WOMAC items are: none, mild, moderate, severe, and extreme. The sum of all items ranges from 0 to 96. Higher scores on the WOMAC total score indicate worse condition.|6 month|||score||Standard Deviation|Mean
841193|NCT01342458|Secondary|WOMAC Physical Function Subscale|The physical function subscale included in the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) index consists of seventeen questions (Likert Scale) relating to the patient's physical activities, or skills to move out and take care of themselves. The Likert Scale version used for all WOMAC items are: none, mild, moderate, severe, and extreme. The sum of all items of physical function subscale ranges from 0 to 68. Higher scores on the physical function WOMAC subscale indicate worse functional limitations.|6 month|||score||Standard Deviation|Mean
841194|NCT01342458|Secondary|WOMAC Stiffness Subscale|The stiffness subscale included in the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) index consists of two questions (Likert Scale) relating articular function of the patient. The Likert Scale version used for all WOMAC items are: none, mild, moderate, severe, and extreme. The sum of all items of the stiffness subscale ranges from 0 to 8. Higher scores on the stiffness WOMAC subscale indicate worse articular function.|6 month|||score||Standard Deviation|Mean
841195|NCT01342458|Primary|Western Ontario and McMaster Universities (WOMAC) Pain Subscale|The WOMAC (Western Ontario and McMaster Universities) pain subscale consists of five questions (Likert Scale) relating to the patient's pain in everyday situations. The Likert Scale version used for all WOMAC items are: none, mild, moderate, severe, and extreme. The sum of all items of pain subscale ranges from 0 to 20. Higher scores indicate worse pain.|6 month|An intention-to-treat analysis was performed, and the missing data were treated as missing completely at random (MCAR) using the Mahalanobis imputation method (SOLAS software version 4.0; Statistical Solutions Ltd., Cork, Ireland).||score||Standard Deviation|Mean
841196|NCT01342471|Secondary|TV Viewing Time|Change in self-reported TV viewing time per day between 0 and 6 months|0 and 6 months|||hr/day||Standard Deviation|Mean
841197|NCT01342471|Secondary|Weight|Change in weight in kgs between 0 and 6 months|0 and 6 months|||kg||Standard Deviation|Mean
841198|NCT01342471|Secondary|TV Related Energy Intake|Change in energy intake (kcals/day) while watching TV between 0 and 6 months|0 and 6 months|||kcals/day||Standard Deviation|Mean
841199|NCT01342471|Secondary|Total Energy Intake|Change in total energy intake(kcals/day) between 0 and 6 months|0 and 6 months|||kcals/day||Standard Deviation|Mean
841200|NCT01342471|Primary|Physical Activity (Steps/Day)|Change in pedometer measured steps per day between 0 and 6 months|0 and 6 months|||steps/day||Standard Deviation|Mean
841201|NCT01342484|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) After 12 Weeks of Treatment|Change from baseline in FPG (mmol/L) after 12 weeks of treatment with double-blind trial medication. The number of participants analysed displays the number of participants with available data at the timepoint of interest.|Baseline and 12 weeks|Full analysis set (FAS) including all randomised patients who were treated with at least one dose of study drug and had a baseline and at least one on-treatment HbA1c assessment. Observed Case (OC): In the OC analysis, values after the use of rescue medication were set to missing.||mmol/L||Standard Error|Least Squares Mean
841202|NCT01342484|Secondary|Dipeptidyl-peptidase-4 (DPP-4) Inhibition (%) at Trough at Steady State|DPP-4 inhibition (%) at trough at steady state is the relative change between the measurement of DPP-4 activity taken 0.5 hours before dosing at baseline and the first available on-treatment measurement of DPP-4 activity taken 0.5 hour before dosing at week 4, 8 or 12: DPP-4 inhibition (%) = 100 - (DPP-4 activity at week X / DPP-4 activity at baseline) x 100.|Baseline and 4 weeks or 8 weeks or 12 weeks|Full analysis set (FAS) including all randomised patients who were treated with at least one dose of study drug and had a baseline and at least one on-treatment HbA1c assessment. OR (Original Results). The analysis excludes placebo patients and 1 FAS patient from Linagliptin 1 mg group.||Percentage of DPP-4 inhibition||Inter-Quartile Range|Median
841203|NCT01342484|Primary|Change From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 12 Weeks of Treatment|Change from baseline in Glycosylated haemoglobin (HbA1c) [%] after 12 weeks of treatment with double-blind trial medication. Baseline was defined as the last observation before the first intake of any double-blind randomised trial medication. The number of participants analysed displays the number of participants with available data at the timepoint of interest.|Baseline and 12 weeks|Full analysis set (FAS) including all randomised patients who were treated with at least one dose of study drug and had a baseline and at least one on-treatment HbA1c assessment. Observed Case (OC): In the OC analysis, values after the use of rescue medication were set to missing.||Percentage of HbA1c||Standard Error|Least Squares Mean
841204|NCT01342510|Primary|Number of Patients With Pain Associated With Injection of Propofol.|Ten seconds following injection of propofol, subjects were asked “Are you having pain at your IV site?” Any behavioral signs were noted. Injection pain was assessed using the following four point scale: 0 = no pain; 1 = mild pain (pain reported only in response to questioning and without behavioral signs); 2 = moderate pain (pain reported in response to questioning and accompanied by a behavioral sign, or pain reported spontaneously without questioning); and 3 = severe pain (strong vocal response or response accompanied by facial grimacing, arm withdrawal, or tears).|< 1 minute.|||participants|||Number
841205|NCT01342510|Primary|Pain With Injection of Propofol|Following injection of the study drug, 50 mg of propofol will be injected. Ten seconds after propofol, subjects will be asked a standard question about pain. Behavioral signs will be noted. Pain will be assessed using a four point scale: 0=no pain, 1=mild pain (pain reported only in response to questioning and without behavioral signs), 2=moderate pain (pain reported in response to questioning and a behavioral sign, or pain reported without questioning), 3=severe pain (strong vocal response or behavioral response).|Approximately one minute following administration of propofol.||||||
841206|NCT01342523|Secondary|Increased Quit Attempts|Quit attempts will be defined in two ways: self-report of a serious attempt to quit, and occurrence of at least a 24 hr period of abstinence that was for the purpose of cessation.|Measured at the 1 month, 3 month and 7 month follow up assessments.||||||
841207|NCT01342523|Secondary|Treatment Satisfaction|We will measure how satisfied participants were with the resources they were given as well as what might have made their quit attempts easier or more successful.|Measured at the 1 month, 3 month and 7 month follow up assessments||||||
841208|NCT01342523|Secondary|Perceived Support|We will measure perceived support from both treatment and non-treatment resources.|Measured at the1 month, 3 month and 7 month follow up assessments.||||||
841209|NCT01342523|Secondary|Withdrawal Symptoms|We will measure the manifestation and severity of withdrawal symptoms of participants in each treatment group.|Measured at the1 week, 2 week, 3 week, 1 month, 3 month and 7 month follow up assessments.||||||
841210|NCT01342523|Secondary|Effectiveness of the Experimental Resources.|We will measure how these experimental resources (as well as combinations of resources) aid in quit attempts and abstinence outcomes.|Data collected at all assessments (Measured at the1 week, 2 week, 3 week, 1 month, 3 month and 7 month follow ups), during web use measurements (6 months), and counseling calls measurements (4 weeks). Analyzed after the study.||||||
841211|NCT01342523|Secondary|Resource Use/Engagement|We will measure participants' use the experimental resources compared to the non-experimental resources. Particularly with the study websites, we will be tracking how often and how long participants use the regular smokefree.gov website versus the placebo website as well as what parts of the websites they are using for 6 months.|Assessed at the 7 month follow up assessment. Furthermore, Website use will be collected as pages viewed, time viewed, use occasions, and composite measures. Counseling use will be measured by number of counseling calls.||||||
841212|NCT01342523|Secondary|Smoking Outcomes|Inclusive of smoking rate amongst those smoking, smoking cessation milestones: initial cessation, lapse latency, lapse-relapse latency; and setting a quit date.|Measured at the1 week, 2 week, 3 week, 1 month, 3 month and 7 month follow up assessments.||||||
841213|NCT01342523|Primary|7-Day Point-Prevalence Abstinence From Smoking|Abstinence will be defined as 7-day point prevalence.|Measured after the 3 month follow up assessment|"Intention to treat (ITT)"||percentage of participants not smoking|||Number
841214|NCT01342549|Primary|Time to Relapse to Heavy Drinking as Defined by Having 5 or More Drinks in a Sitting for Men and Will be Assessed Using the Time Line Follow Back for Recent Drinking Method. A Structured Questionnaire Will Review Alcohol Consumed on the Previous Week.||24 weeks|||Weeks||Standard Deviation|Mean
841215|NCT01342640|Primary|Change From Baseline in Mean Hb Concentration at Week 28|PP Population: All participants in the safety population (all enrolled participants) except participants with less than 3 recorded Hb values in Weeks 20 to 28; who missed methoxy polyethylene glycol-epoetin beta dose in Weeks 20 to 28; who withdrew before efficacy evaluation period (Weeks 20 to 28); and participants with inadequate iron status (defined as mean serum ferritin ≤ 100 ng/mL or TSAT ≤20% or mean hypochromic RBCs ≥ 10% during efficacy evaluation period [Weeks 20 to 28]).|Baseline (Week 0), Week 28|PP Population. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome||gm/dL||Standard Deviation|Mean
841216|NCT01342640|Primary|Change From Baseline in Mean Hb Concentration at Week 24|PP Population: All participants in the safety population (all enrolled participants) except participants with less than 3 recorded Hb values in Weeks 20 to 28; who missed methoxy polyethylene glycol-epoetin beta dose in Weeks 20 to 28; who withdrew before efficacy evaluation period (Weeks 20 to 28); and participants with inadequate iron status (defined as mean serum ferritin ≤ 100 ng/mL or TSAT ≤20% or mean hypochromic RBCs ≥ 10% during efficacy evaluation period [Weeks 20 to 28]).|Baseline (Week 0), Week 24|PP Population. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome.||gm/dL||Standard Deviation|Mean
841231|NCT01342770|Secondary|Number of Participants With Clinical Response, Based on Response Evaluation Criteria in Solid Tumors ( RECIST) Version 1.1|Clinical response rates will be summarized. Complete response (CR) is the disappearance of all non-nodal target lesions (TL) and each target lymph node (LN) must have reduction in short axis to <1.0cm. Partial Response (PR) is at least a 30% decrease in the sum of the longest diameters (LD) of the non-nodal TR and the short axis of the target LN with the baseline sum diameters (BSD) as reference. Progression (PD) is at least 1 new malignant lesion or LN whose short axis increased to >1.5 cm or at least a 20% increase in the sum of TL diameters with the minimum sum of diameters as reference.|Up to the time of surgery||||||
841217|NCT01342640|Primary|Change From Baseline in Mean Hb Concentration at Week 20|Per Protocol (PP) Population: All participants in the safety population (all enrolled participants) except participants with less than 3 recorded Hb values in Weeks 20 to 28; who missed methoxy polyethylene glycol-epoetin beta dose in Weeks 20 to 28; who withdrew before efficacy evaluation period (Weeks 20 to 28); and participants with inadequate iron status (defined as mean serum ferritin less than or equal to [≤] 100 nanogram per milliliter [ng/mL] or mean transferrin saturation [TSAT] ≤20% or mean hypochromic red blood cells [RBCs] greater than or equal to [≥] 10% during efficacy evaluation period [Weeks 20 to 28]).|Baseline (Week 0), Week 20|PP Population. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome and n signifies those participants who were evaluable for specified time-point.||Grams per deciliter (gm/dL)||Standard Deviation|Mean
841218|NCT01342666|Primary|High Density Lipoprotein Cholesterol (HDL-c)|To evaluate the effect of two daily tomatoes consumption on HDL-c levels.|Baseline and after one month|The sample size was calculated using the formula for means for two-tailed comparisons. According to a previous report, we expected a minimal change of 5 mg/dL in HDL-c after one month of consumption. Using a SD of 9 mg/dL with alfa of 0.05 and study power of 80%, a total of 48 subjects were calculated.||mg/dL||Standard Deviation|Mean
841219|NCT01342757|Primary|Measurable Change on Magnetic Resonance Spectroscopy Imaging After Vorinostat Administration|Changes in magnetic resonance spectroscopic imaging signal and semiquantitative analysis of inositol, choline, lactate, and NAA signal are measured. The values for each of these metabolites are normalized to baseline at one and nine weeks. The values of all the metabolites at one week are added and this is the magnetic resonance spectroscopic index for one week. This is done again at nine weeks. The number is unitless and there is no range limit. Positive values represent normalization of tumor metabolism and negative values suggest no improvement or worsening of metabolic character.|9 weeks|Patients collected until measurable spectroscopic indexes were available in at least three cases with metabolic response and three without metabolic response||Spectroscopic index||Standard Deviation|Mean
841220|NCT01342757|Secondary|Mean (or Median) Change in Metabolite Levels||Baseline to 1 week||||||
841221|NCT01342757|Primary|Proportion of Patients Who Experience Metabolic Restoration Between the Responders and Non-responder Groups by MRS Scans||After 1 week||||||
841222|NCT01342757|Primary|Proportion of Patients With Magnetic Resonance Spectroscopy Response to Initial Vorinostat by MRI and MRS Scans as Determined by Spectroscopic Index|Changes in magnetic resonance spectroscopic imaging signal and semiquantitative analysis of inositol, choline, lactate, and N-acetylaspartate signal are measured. The values for each of these metabolites are normalized to baseline at one and nine weeks. The values of all the metabolites at one week are added and this is the magnetic resonance spectroscopic index for one week. This is done again at nine weeks. The number is unitless and there is no range limit. Positive values represent normalization of tumor metabolism and negative values suggest no improvement or worsening of metabolic character.|9 weeks|||participants|||Number
841223|NCT01342770|Secondary|Post-intervention SUV of PET Scan|The pre- and post-intervention SUV will be summarized using descriptive statistics and simple graphical plots.|Time of surgery|Includes registered eligible participants with pre- and post-intervention PET/CT images obtained||SUV||Full Range|Median
841224|NCT01342770|Secondary|Pre-intervention SUV of PET Scan|The pre- and post-intervention SUV will be summarized using descriptive statistics and simple graphical plots.|Baseline|Includes registered eligible participants with pre- and post-intervention PET/CT images obtained||SUV||Full Range|Median
841225|NCT01342770|Secondary|Percent Change in SUVmax From the PET Scan|The percent change from pre to post-intervention in SUV max values will be summarized using descriptive statistics and simple graphical plots.|Baseline to the time of surgery|Includes registered eligible participants with pre- and post-intervention PET/CT images obtained||Percent change in tumor SUV max values||Full Range|Median
841226|NCT01342770|Secondary|Percent Change in PPARy|Changes in the expression levels from baseline (prior to intervention) to post intervention (resected tumor sample) will be plotted graphically as well as formally assessed using Wilcoxon signed rank tests.|Baseline to the time of surgery|Includes all registered participants with pre- and post-intervention tumor tissue samples except one participant who was deemed ineligible post-registration||Percent change in PPARy measurements||Full Range|Median
841227|NCT01342770|Secondary|Percent Change in p21|Changes in the expression levels from baseline (prior to intervention) to post intervention (resected tumor sample) will be plotted graphically as well as formally assessed using Wilcoxon signed rank tests.|Baseline to the time of surgery|Includes all registered participants with pre- and post-intervention tumor tissue samples except one participant who was deemed ineligible post-registration||Percent change in p21 measurements||Full Range|Median
841228|NCT01342770|Secondary|Percent Change in MUC1|Changes in the expression levels from baseline (prior to intervention) to post intervention (resected tumor sample) will be plotted graphically as well as formally assessed using Wilcoxon signed rank tests.|Baseline to the time of surgery|Includes all registered participants with pre- and post-intervention tumor tissue samples except one participant who was deemed ineligible post-registration||Percent change in MUC1 measurements||Full Range|Median
841229|NCT01342770|Secondary|Percent Change in Cyclin D1|Changes in the expression levels from baseline (prior to intervention) to post intervention (resected tumor sample) will be plotted graphically as well as formally assessed using Wilcoxon signed rank tests.|Baseline to the time of surgery|Includes all registered participants with pre- and post-intervention tumor tissue samples except one participant who was deemed ineligible post-registration||Percent change in Cyclin D1 measurements||Full Range|Median
841230|NCT01342770|Secondary|Number of Participants With Complete Pathologic Response|Complete pathologic response was defined as no viable residual tumor cells. Acellular residual mucin pools also considered a pathologic complete response.|Up to the time of surgery|Includes all registered participants||participants|||Number
841232|NCT01342770|Secondary|Incidence of Adverse Events Graded According to Common Terminology Criteria for Adverse Events Version 4.0|To evaluate the adverse events profile, the maximum grade for each type of adverse event will be recorded for each participant and frequency tables will be reviewed to determine the overall patterns. The number and severity of adverse events (both regardless of attribution as well as those that are at least possibly, probably, or definitely related) will be tabulated and summarized.|Up to the time of surgery|Includes all registered eligible participants||participants|||Number
841233|NCT01342770|Secondary|Gene Expression Analysis of RNA From Bronchial Brush Cells|For the gene expression profiles obtained from the data from normal bronchial brush cells, each participant’s pre- and post gene expression will be graphically represented and the mean expression levels analyzed using a paired t-test or Wilcoxon signed rank test, if the assumptions of the t-test are not met.|Up to the time of surgery||||||
841234|NCT01342770|Secondary|Change in Levels of Serum CRP|Each participant’s pre- and post serum levels of CRP will be graphically represented and the mean levels analyzed using a paired t-test or Wilcoxon signed rank test, if the assumptions of the t-test are not met.|Baseline to the time of surgery||||||
841235|NCT01342770|Secondary|Change in Levels of Serum CA-153|Each participant’s pre- and post serum levels of CA-153 will be graphically represented and the mean levels analyzed using a paired t-test or Wilcoxon signed rank test, if the assumptions of the t-test are not met.|Baseline to the time of surgery||||||
841236|NCT01342770|Secondary|Change in Apoptosis Assessment (e.g., Caspase-3)|Changes in the expression levels (or grades) from baseline (prior to intervention) to post-intervention (resected tumor sample) will be plotted graphically as well as formally assessed using the McNemar’s tests (for categorical variables) or Wilcoxon signed rank tests (for continuous variables) respectively.|Baseline to the time of surgery||||||
841237|NCT01342770|Primary|Percent Change in Ki-67 by Immunohistochemistry (IHC)|Changes in the expression levels of Ki-67 will be plotted graphically, and percent change in expression levels will be formally assessed using the paired t-test or the Wilcoxon signed rank test, if the assumptions of the t-test (i.e. normality) are not met.|Baseline to the time of surgery|Includes all registered participants with pre- and post-intervention tumor tissue samples except one participant who was deemed ineligible post-registration||Percent change in Ki-67 measurements||Full Range|Median
841238|NCT01342887|Secondary|Frequency and Severity of Regimen-associated Toxicities|Estimate the frequency and severity of regimen-associated toxicities, along with 28-day mortality after start of study treatment|At 28 days|||Participants|||Count of Participants
841239|NCT01342887|Secondary|Disease-free Survival of Patients That Achieve CR/CRi|Describe the disease-free survival of patients that achieve CR/CRi.|Up to 4.5 years|||Participants|||Count of Participants
841240|NCT01342887|Secondary|CR/CRi|"Describe the disease-free survival of patients that achieve Complete Remission (CR)/CR with inadequate recovery of peripheral blood cell counts (CRi).
Categorized according to criteria recommended by an International Working Group."|After completion of first 2 courses, up to 22 weeks|||Participants|||Count of Participants
841241|NCT01342887|Primary|Maximum Tolerated Doses Mitoxantrone Hydrochloride and Etoposide When Combined With Cyclosporine and Pravastatin Sodium|"Determine the doses of mitoxantrone and etoposide that, when combined with CSA and pravastatin, meet minimum standards for both efficacy and toxicity and have the highest efficacy rate among several mitoxantrone and etoposide doses.
Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0."|After completion of first 2 courses, up to 22 weeks|||doses tolerated|||Number
841242|NCT01342913|Secondary|Change From Baseline in Trough FEV1 on Treatment Day 85|Pulmonary function was measured by forced expiratory volume in one second (FEV1). Trough FEV1 was defined as the 24-hour FEV1 assessment, which was obtained on Day 85. Baseline is defined as the mean of the two assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1.Change from Baseline was calculated as the average of the Day 85 values minus the Baseline value.|Baseline and Day 85|Only participants available at the indicated time point were assessed.||Liters||Standard Error|Least Squares Mean
841243|NCT01342913|Secondary|Time to Onset on Treatment Day 1|Time to onset on Treatment Day 1 is defined as the time to an increase of 100 milliliters (mL) from Baseline in FEV1. Time of onset was calculated over 0 to 4 hours (5 min, 15 min, 30 min, 60 min, 120 min, and 240 min) post-dose.|Day 1|ITT Population. Only participants available at the indicated time point were assessed.||Minutes||Full Range|Median
841244|NCT01342913|Primary|Change From Baseline Trough in 24-hour Weighted-mean FEV1 on Treatment Day 84|Pulmonary function was measured by forced expiratory volume in one second (FEV1). The weighted mean was calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5, 15, 30, and 60 minutes (min) and 2, 4, 6, 8, 12, 13, 14, 16, 20, and 24 hours on Treatment Day 84. Baseline trough FEV1 was the mean of the two assessments made 30 and 5 minutes pre-dose on Treatment Day 1. Change from Baseline was calculated as the average of the Day 84 values minus the Baseline value.|Baseline and Day 84|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least 1 dose of double-blind medication. Randomized participants were assumed to have received double-blind medication unless definitive evidence to the contrary existed. Only participants available at the indicated time point were assessed.||Liters||Standard Error|Least Squares Mean
841245|NCT01342926|Secondary|The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22)|Blood samples were collected at the indicated time points on Baseline, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15 and Month 18. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15 and Month 18|PD Concentration Population: all participants in the ITT Population with at least one PD sample||picogram (PG)/ML||Standard Deviation|Mean
841246|NCT01342926|Secondary|Volume of Distribution at Steady-state (Vdss) of GSK933776 in Geographic Atrophy Participants Estimated From Population PK Modeling|Blood samples were collected at the indicated time points on Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476.|Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476|PK Parameter Population||mL||95% Confidence Interval|Geometric Mean
841247|NCT01342926|Secondary|Estimation of Terminal Phase Half-life (T1/2) of GSK933776 in Geographic Atrophy Participants|Blood samples were collected at the indicated time points on Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476.|Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476|PK Parameter Population||Days||95% Confidence Interval|Geometric Mean
841248|NCT01342926|Secondary|Clearance (CL) of GSK933776 in Geographic Atrophy Participants|Blood samples were collected at the indicated time points on Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476.|Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476|PK Parameter Population||mL/h||95% Confidence Interval|Geometric Mean
841249|NCT01342926|Secondary|Maximum Observed Plasma Concentration (Cmax) and Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ctau) of GSK933776 in Geographic Atrophy Participants|Blood samples were collected at the indicated time points on Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476|Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476|PK Parameter Population||nanogram (ng)/mL||95% Confidence Interval|Geometric Mean
841250|NCT01342926|Secondary|Area Under the Plasma Concentration-time Curve From Time 0 to the End of Dosing Interval at Steady-state (AUC0-28d) of GSK933776 in Geographic Atrophy Participants|Area under the plasma concentration-time curve from time 0 to the end of dosing interval at steady-state; derived from dose and clearance parameters was evaluated. Blood samples were collected at the indicated time points on Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476.|Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476|Pharmacokinetic (PK) Parameter Population: all participants in the ITT Population with derived PK parameters||microgram (mcg)*hours (h)/mL||95% Confidence Interval|Geometric Mean
841251|NCT01342926|Secondary|Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18|Participants enrolled into the study were required to have a best-corrected ETDRS visual acuity score of at least 35 letters as determined by ETDRS-BCVA evaluation. ETDRS-BCVA score was assessed as change from baseline in the mean best-corrected ETDRS visual acuity score at 18 months. Change from Baseline is defined as post-dose visit value minus Baseline value. Note that screening occurs before baseline. Values were truncated to one decimal place and negative sign retained where value is negative and the truncated value is zero. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and every month up to Month 18|ITT Population||Scores on a scale||Standard Deviation|Mean
841252|NCT01342926|Secondary|Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye|Participants enrolled into the study were required to have a best-corrected ETDRS visual acuity score of at least 35 letters as determined by ETDRS-BCVA evaluation. ETDRS-BCVA score was assessed at the indiated time points at: Month 12 and Month 18 with categorical changes in the number of participants losing >30, >=15, >=10, >=5 and <5 letters.|Month 12 and Month 18|ITT Population||Participants|||Number
841253|NCT01342926|Secondary|Change From Baseline in Area of Total hypoAF in Study Eye|Atrophic AMD also called as GA is characterized by thinning of the retinal pigment epithelium (RPE) and underlying choriocapillaris, as well as overlying photoreceptors in the macula. GA was evaluated by fundus autofluorescence at the indicated time points: screening, 6 months, 12 months and at 18 months. Change from Baseline: (Month 6, 12, 18 value minus Baseline value, respectively. Note screening occurs before baseline). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, 6 months, 12 months and 18 months|Efficacy Population||mm^2||90% Confidence Interval|Mean
841254|NCT01342926|Secondary|Change From Baseline in Area of GA Assessed by Fundus Autofluorescence Images (hypoAF) Corresponding to GA in Study Eye|Atrophic AMD also called as GA is characterized by thinning of the retinal pigment epithelium (RPE) and underlying choriocapillaris, as well as overlying photoreceptors in the macula. GA was evaluated by fundus autofluorescence images in the study eye at the indicated time points: screening, 6 months, 12 months and at 18 months. Change from Baseline: (months 6, 12,18 value minus Baseline value, respectively. Note screening occurs before baseline). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, 6 months, 12 months and 18 months|Efficacy Population||mm^2||90% Confidence Interval|Mean
841255|NCT01342926|Primary|Number of Participants With Abnormal Magnetic Resonance Imaging (MRI)|Magnetic Resonance Imaging (MRI) was used as a safety assessment to monitor for amyloid related imaging abnormalities (ARIA) events in the brain. MRIs were performed at Baseline and before dose 2, before dose 3, before dose 4, before dose 6, before dose 12, before dose 18 and at follow-up. ARIA-edema/effusions (ARIA-E) and ARIA hemosiderin deposition (ARIA-H) events at any visit are reported.|Month 2, Month 3, Month 4, Month 6, Month 12, Month 18 and at early withdrawal|ITT Population||Participants|||Number
841256|NCT01342926|Primary|Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI)|The following laboratory parameters were assessed: Hematology: Platelet Count, Red Blood Cell Count, White Blood Cell (WBC) Count, Reticulocyte Count, Hemoglobin, Hematocrit, Prothrombin time-International Normalized Ratio, Activated partial thromboplastin time, Mean corpuscular volume, Mean corpuscular haemoglobin, Mean corpuscular hemoglobin concentration, Neutrophils (ANC), Lymphocytes, Monocytes, Eosinophils, and Basophils. Clinical chemistry: Blood urea nitrogen, Potassium, Aspartate aminotransferase, Total and direct bilirubin Creatinine, Chloride, Alanine aminotransferase, Uric Acid, Glucose (fasting), Total Carbon dioxide , Gamma glutamyltransferase, Albumin, Sodium, Calcium, Alkaline phosphatase, Total Protein, and HbA1c. Urine: Specific gravity, pH, glucose, protein, blood and ketones and Microscopic examination. Only those with PCIs are displayed.|At any point from Baseline through follow-up visit.|ITT Population||Participants|||Number
841257|NCT01342926|Primary|Number of Participants With 12-lead Electrocardiogram (ECG) of Potential Clinical Importance (PCI)|12-lead ECG was obtained after 10 minutes rest in a supine position using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QT interval corrected using the Fridericia's formula (QTcF). Abnormal-clinically significant (CS) ECG measurements are presented at indicated time points: Baseline, Month 6, Month 12, Month 18, early withdrawal and at follow-up visit. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Month 6, Month 12, Month 18, early withdrawal and at follow-up visit|ITT Population||Participants|||Number
841284|NCT01343082|Primary|Change From Baseline in IOP (Intraocular Pressure) at End of Study||Treatment period: Week 0 (Baseline) and Week 52 (End of Study)|||mmHg||Standard Deviation|Mean
841285|NCT01343251|Secondary|Hospitalization Rate (Percentage of Participants Who Were Hospitalized at Least Once While on Study)|Compare incidence of hospitalization (for any reason) between study arms. Reasons for hospitalizations included: infection, cardiac problems, bleeding, vascular access thrombosis, fall (injury), hematuria, fluid overload, peripheral neuropathy, pulmonary embolism, edema, and shortness of breath.|1 year|||Percentage of patients|||Number
841258|NCT01342926|Primary|Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Heart Rate (HR)|Vital signs included HR of CCR at the indicated time points: Baseline, Month 0, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15, Month 16, Month 17, Month 18, early withdrawal and at follow-up visit in sitting position. 'General' is an assessment time not relative to dosing. HR was defined as: low:< 40 beats per minute (bpm) and high: >100 bpm. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Only categories with at least one PCI value are presented.|Baseline, Month 0, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15, Month 16, Month 17, Month 18, early withdrawal and at follow-up visit|ITT Population||Participants|||Number
841259|NCT01342926|Primary|Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Vital signs included SBP and DBP of Potential Clinical Importance (PCI) at the indicated time points: Baseline, month 0, month 1, month 2, month 3, month 4, month 5, month 6, month 7, month 8, month 9, month 10, month 11, month 12, month 13, month 14, month 15, month 16, month 17, month 18, early withdrawal and at follow-up visit in sitting position. 'General' is an assessment time not relative to dosing. SBP was defined as: low: <85 millimeter of mercury (mmHg) and high: >160 mmHg and DBP was defined as: low:<45 mmHg and high: >100 mmHg. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Only categories with at least one PCI value are presented.|Up to 21 months|ITT Population||Participants|||Number
841260|NCT01342926|Primary|Number of Participants With Ocular or Non-ocular Serious Adverse Events (SAEs) During the Treatment Period||Up to 21 months|ITT Population||Participants|||Number
841261|NCT01342926|Primary|Number of Participants With Ocular or Non-ocular Adverse Events (AEs) During the Treatment Period|An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. It includes:1. Any abnormal laboratory test results or other safety assessments including those that worsen from Baseline, and felt to be clinically significant in the medical and scientific judgment of the Investigator 2.Exacerbation (increase in frequency/intensity) of a chronic or intermittent pre-existing condition 3. New conditions detected or diagnosed after screening visit 4. Signs, symptoms, or the clinical sequelae of a suspected interaction/suspected overdose of investigational product or a concomitant medication. AEs were presented as non-ocular and ocular AEs.|Up to 21 months|ITT Population: all participants that completed the observation period and Baseline visit, and were subsequently randomized to treatment and were administered at least one IV dose.||Participants|||Number
841262|NCT01342926|Primary|Change From Baseline in the Area of Geographic Atrophy (GA) Assessed by Color Fundus Photographs (FP) in the Study Eye|Atrophic age-related macular degeneration (AMD) also called GA is characterized by thinning of the retinal pigment epithelium (RPE) and underlying choriocapillaris, as well as overlying photoreceptors in the macula. GA was evaluated by color FP at the indicated time points: screening, 6 months, 12 months and 18 months. Change from BL: (screening, month 6, 12 or 18 value minus BL value. Note screening occurs prior to BL). Only participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Efficacy Population: all participants in the Intent-to-Treat (ITT) Population who met the protocol defined inclusion criterion for area of GA assessed by color FP in the study eye in at least one visit from screening visit through BL visit, inclusive and had data of area of GA assessed by fundus autofluorescence images in the study eye for at least 75% of the visits (>=14 visits) from post-BL treatment month 2 visit to treatment month 19 visit.|Baseline (BL), 6 months, 12 months and 18 months|Efficacy Population. Participants who developed CNV in the study eye during the treatment period are excluded from Efficacy Population per protocol.||square millimeter (m^2)||90% Confidence Interval|Mean
841263|NCT01342965|Secondary|Quality of Life: Functional Assessment of Chronic Illness Therapy - Lung (FACIT-L) Questionnaire||approximately 21 months||||||
841264|NCT01342965|Secondary|Safety: Incidence of Adverse Events||36 months||||||
841265|NCT01342965|Secondary|Overall Survival|Overall survival was defined as the time from the date of randomization to the date of death from any cause.|Baseline to the end of the study (3 years, 1 month)|Full analysis set: All randomized participants.||Months||95% Confidence Interval|Median
841266|NCT01342965|Secondary|Duration of Response|Duration of response was defined as the time from the first documented complete response (CR) or partial response (PR) to the first documented disease progression (PD) or death, whichever occurs first. A CR was defined as the disappearance of all target lesions (TL). A PR was defined as at least a 30% decrease in the sum of the longest diameter (SLD) of TLs taking as reference the Baseline SLD. PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since treatment started or the unequivocal progression of existing non-TLs.|Baseline to the data cut-off date of 19 Nov 2012 (1 year, 8 months)|Full analysis set: All randomized participants. Only participants who had a complete response or partial response were included in the analysis.||Months||95% Confidence Interval|Median
841267|NCT01342965|Secondary|Percentage of Participants With Disease Control|A participant with disease control was defined as a participant with either a complete response (CR), a partial response (PR), or stable disease (SD), as determined using RECIST v1.1. A CR was defined as the disappearance of all target lesions (TL). A PR was defined as at least a 30% decrease in the sum of the longest diameter of TLs taking as reference the Baseline sum longest diameter (SLD). SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest SLD since treatment started. For non-TLs, SD was defined as the persistence of 1 or more lesions. PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since treatment started or the unequivocal progression of existing non-TLs. A SLD for all TLs will be calculated and reported as the Baseline SLD.|Baseline to the data cut-off date of 19 Nov 2012 (1 year, 8 months)|Full analysis set: All randomized participants.||Percentage of participants|||Number
841297|NCT01343368|Secondary|Comparison of Antimullerian Hormone (AMH) Levels After Transplant|Comparison of treatment arms; interventional versus observational average AMH levels after receiving transplant.|Day Prior to Transplant|Six patients on the Observational arm never had any follow-up AMH levels drawn and were removed from this analysis.||ng/ml||Standard Deviation|Mean
841268|NCT01342965|Secondary|Percentage of Responders as Assessed by the Investigator|A responder was defined as a participant with either a complete response (CR) or a partial response (PR), as determined using the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. A CR was defined as: (1) The disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to < 10 mm. (2) The disappearance of all non-target lesions and normalization of tumor marker levels. All lymph nodes must be non-pathological in size (< 10 mm in the short axis). A PR was defined as: (1) At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. (2) The persistence of 1 or more non-target lesion(s) and/or maintenance of tumor marker levels above normal limits.|Baseline to the data cut-off date of 19 Nov 2012 (1 year, 8 months)|Full analysis set: All randomized participants.||Percentage of responders|||Number
841269|NCT01342965|Primary|Investigator-assessed Duration of Progression-free Survival|The duration of progression-free survival was defined as the time from randomization to disease progression (PD) or death from any cause, whichever occurs first. PD was defined as: (1) At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this may include the baseline sum). The sum must also demonstrate an absolute increase of at least 5 mm. (2) An unequivocal progression of existing non-target lesions. When the patient has measurable disease, the overall tumor burden must have increased sufficiently to merit discontinuation of therapy. When the patient has only non-measurable disease, the increase in overall disease burden should be comparable in magnitude to the increase that would be required to declare PD for measurable disease. (3) The appearance of new malignant lesions.|Baseline to the data cut-off date of 20 Jul 2012 (1 year, 4 months)|Full analysis set: All randomized participants.||Months||95% Confidence Interval|Median
841270|NCT01343004|Secondary|Number of Treatment-Emergent Adverse Events Associated With Hypercalcemia at 18 Months||18 months|Safety population included all patients who received 1 or more doses of study medication||Hypercalcemic events|||Number
841271|NCT01343004|Secondary|Number of Participants With Non-vertebral Fractures at 18 Months||18 months|Intent-to-treat population included all patients who were randomized into the study by assigning the randomized study medication kit on Day 1.||Participants|||Number
841272|NCT01343004|Secondary|Percent Change in Bone Mineral Density (BMD) of Femoral Neck From Baseline to Month 18||Baseline and 18 months|Intent-to-treat population included all patients who were randomized into the study by assigning the randomized study medication kit on Day 1. Baseline BMD data were missing for some patients; the method of last observation carried forward (LOCF) was used to impute missing data.||percent change||Standard Deviation|Mean
841273|NCT01343004|Secondary|Percent Change in Bone Mineral Density (BMD) of Total Hip From Baseline to Month 18||Baseline and 18 months|Intent-to-treat population included all patients who were randomized into the study by assigning the randomized study medication kit on Day 1. Baseline BMD data were missing for some patients; the method of last observation carried forward (LOCF) was used to impute missing data.||percent change||Standard Deviation|Mean
841274|NCT01343004|Secondary|Percent Change in Bone Mineral Density (BMD) of Lumbar Spine From Baseline to 18 Months||Basline and 18 months|Intent-to-treat population included all patients who were randomized into the study by assigning the randomized study medication kit on Day 1. Baseline BMD data were missing for some patients; the method of last observation carried forward (LOCF) was used to impute missing data.||percent change from baseline||Standard Deviation|Mean
841275|NCT01343004|Primary|Number of Participants With New Vertebral Fractures at 18 Months||18 months|Modified intent-to-treat (MITT) population included all patients with pre-treatment and end-of-treatment evaluable radiologic assessment (spine X-ray).||participants|||Number
841276|NCT01343056|Secondary|Systolic Blood Pressure|Systolic blood pressure is the pressure when the heart beats while pumping blood.|6 months|Number of participants analyzed represents the number of participants who completed a 6 month follow up visit and, therefore, differs from numbers reported in the Participant Flow Module.||mmHg||Full Range|Median
841277|NCT01343056|Secondary|Diastolic Blood Pressure|Diastolic blood pressure is the pressure when the heart is at rest between beats.|6 months|Number of participants analyzed represents the number of participants who completed a 6 month follow up visit and, therefore, differs from numbers reported in the Participant Flow Module.||mmHg||Full Range|Median
841278|NCT01343056|Secondary|Body Mass Index|Body Mass Index is a weight-to-height ratio, calculated by dividing one's weight in kilograms by the square of one's height in meters and used as an indicator of obesity and underweight.|6 months|Number of participants analyzed represents the number of participants who completed a 6 month follow up visit and, therefore, differs from numbers reported in the Participant Flow Module.||kg/m^2||Full Range|Median
841279|NCT01343056|Secondary|Change in Diabetes Empowerment Scale- Short Form (DES-SF) Scores|"The DES-SF is a validated, 8 item scale that measures the self-efficacy of patients with diabetes. Responses are selected from a 5-point Likert scale (Strongly Disagree (1), Somewhat Disagree (2), Neutral (3), Somewhat Agree (4), Strongly Agree (5)). The scale is scored by averaging the scores of all completed items (sum of scores divided by 8).
A positive number represents an improvement in overall patient self-efficacy (empowerment) from the baseline score and 6 month follow up time point."|6 months|Number of participants analyzed represents the number of participants who completed a 6 month follow up visit and, therefore, differs from numbers reported in the Participant Flow Module.||units on a scale||Standard Deviation|Mean
841280|NCT01343056|Secondary|Low Density Lipoprotein (LDL, mg/dL)||6 months|Number of participants analyzed represents the number of participants who completed a 6 month follow up visit and, therefore, differs from numbers reported in the Participant Flow Module.||mg/dL||Full Range|Median
841281|NCT01343056|Secondary|High Density Lipoprotein (HDL, mg/dL)||6 months|Number of participants analyzed represents the number of participants who completed a 6 month follow up visit and, therefore, differs from numbers reported in the Participant Flow Module.||mg/dL||Full Range|Median
841282|NCT01343056|Secondary|Total Cholesterol (mg/dL)||6 months|Number of participants analyzed represents the number of participants who completed a 6 month follow up visit and, therefore, differs from numbers reported in the Participant Flow Module.||mg/dL||Full Range|Median
841283|NCT01343056|Primary|Hemoglobin A1C (HbA1C, %)||6 months|Number of participants analyzed represents the number of participants who completed a 6 month follow up visit and, therefore, differs from numbers reported in the Participant Flow Module.||percentage of glycosolated hemoglobin||Full Range|Median
841286|NCT01343251|Secondary|Intervention Rate (Percentage of Participants Who Required at Least One Intervention While on Study)|Compare vascular intervention rates between study arms. The vascular interventions which were included were: Angioplasty, Thrombectomy, Arteriovenous (AV) Fistulogram/Diagnostic Angiogram, Banding, Access Removal, Access Exchange, Access Revision, Creation of New Access, and any combination of these interventions which were performed simultaneously.|1 year|||percentage of participants|||Number
841287|NCT01343251|Secondary|Quality of Life|Compare the RAND Short Form (SF)-36 Health Survey, Total Test Scores at baseline, 3, 6, and 12 months between study arms. Total test scores range on a scale from 0-100, with the lower the score equating to more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. The total score is calculated using a methodology described by the RAND Corporation, which assigns a recoded value to each survey item. Recoded items are averaged amongst scales and the total score is an average of the eight sections. (http://www.rand.org/content/dam/rand/www/external/health/surveys_tools/mos/mos_core_36item_scoring.pdf).|1 year|The number of completed tests varied by time point and study group. The number of completed tests for Test 1, Test 2, Test 3, and Test 4 was 14, 13, 10, and 8 for the HeRO Graft group and 17, 13, 7, and 4 for the Control group, respectively. Only completed tests were included in the analysis.||units on a scale||Standard Deviation|Mean
841288|NCT01343251|Secondary|Infection Rate (Percentage of Participants With at Least One Infection)|Compare incidence of infection between study arms|1 year|||Percentage of Patients|||Number
841289|NCT01343251|Primary|Mortality|Compare mortality rate between study arms|1 year|||percentage of participants who died|||Number
841290|NCT01343277|Primary|Overall Survival (OS)|The OS is defined as the time from the date of first dose of study drug to date of death from any cause. If the participant is alive or the vital status is unknown, the participant will be censored at the date the participant will be last known to be alive.|approximately 3 years 8 months (From Study start date [27 May 2011] up to final analysis data cut-off [05 January 2015]|Analysis population included all the randomized participants up to up to final analysis cut-off date (05 January 2015).||Months||95% Confidence Interval|Median
841291|NCT01343277|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|approximately 3 years 8 months (From Study start date [27 May 2011] up to final analysis data cut-off [05 January 2015])|Safety population included all the treated participants.||Participants|||Number
841292|NCT01343277|Secondary|Duration of Response|"Duration of response is defined as the time from the date of initial documentation of a response (CR or PR) to the date of first documented evidence of progressive disease (or relapse for participants who experience CR during the study) or death.
Independent Data Monitoring Committee performed ongoing safety monitoring and conducted the interim analysis after 189 death events and 329 PFS events were observed."|approximately 2 years 4 months (From Study start date [27 May 2011] up to interim analysis data cut-off [16 September 2013])|"Analysis population included all the randomized participants up to interim analysis cut-off date (16 September 2013). N (number of participants analyzed) signifies the participants evaluable for this measure."||Months||95% Confidence Interval|Median
841293|NCT01343277|Secondary|Objective Response Rate|The objective response rate (ORR) is defined as the percentage of participants who achieved a Complete response (CR) or partial response (PR) as best responses. according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST). CR defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to less than 10 millimeter (mm). PR defined as at least 30 percent (%) decrease in sum of the diameters of the target lesions taking as reference the Baseline sum diameters. Confirmed responses are those that persist on repeat imaging study for at least 4 weeks after initial documentation of response. Independent Data Monitoring Committee performed ongoing safety monitoring and conducted the interim analysis after 189 death events and 329 PFS events were observed.|approximately 2 years 4 months (From Study start date [27 May 2011] up to interim analysis data cut-off [16 September 2013])|"Analysis population included all the randomized participants up to interim analysis cut-off date (16 September 2013). N (number of participants analyzed) signifies the participants evaluable for this measure."||Percentage of Participants||95% Confidence Interval|Number
841294|NCT01343277|Secondary|Time to Progression|"Time interval in months between the date of randomization and the date of disease progression or death due to progression, whichever occurred first.
Independent Data Monitoring Committee performed ongoing safety monitoring and conducted the interim analysis after 189 death events and 329 PFS events were observed."|approximately 2 years 4 months (From Study start date [27 May 2011] up to interim analysis data cut-off [16 September 2013])|"Analysis population included all the randomized participants up to interim analysis cut-off date (16 September 2013). N (number of participants analyzed) signifies the participants evaluable for this measure."||Months||95% Confidence Interval|Median
841295|NCT01343277|Secondary|Progression-Free Survival (PFS)|The Progression-Free Survival (PFS) was assessed as median number of months from baseline until the first documented sign of disease progression (increase in disease; radiographic, clinical, or both) or death due to any cause, whichever occurred earlier. Independent Data Monitoring Committee performed ongoing safety monitoring and conducted the interim analysis after 189 death events and 329 PFS events were observed.|approximately 2 years 4 months (From Study start date [27 May 2011] up to interim analysis data cut-off [16 September 2013])|"Analysis population included all the randomized participants up to interim analysis cut-off date (16 September 2013). N (number of participants analyzed) signifies the participants evaluable for this measure."||Months||95% Confidence Interval|Median
841296|NCT01343368|Secondary|Comparison of Antimullerian Hormone (AMH) Levels After Transplant|Comparison of treatment arms; interventional versus observational average AMH levels after receiving transplant.|Day 180 after Transplant|Four patients on the Observational and 10 patients on the Observational arm never had any follow-up AMH levels drawn and were removed from this analysis.||ng/ml||Standard Deviation|Mean
841298|NCT01343368|Secondary|Comparison of Leuprolide Hormone (LH) Levels|Comparison of treatment arms; interventional versus observational average LH levels during study.|2 years|Four patients on the Observational arm never had any follow-up FSH levels drawn and were removed from this analysis. All 7 patients on the Interventional arm and 8 patients on the Observational arm were lost to follow-up.||IU/L||Standard Deviation|Mean
841299|NCT01343368|Secondary|Comparison of Luteinizing Hormone (LH) Levels|Comparison of treatment arms; interventional versus observational average LH levels during study.|1 year|Four patients on the Observational arm never had any follow-up LH levels drawn and were removed from this analysis. Three patients on the Interventional arm and 8 patients on the Observational arm were lost to follow-up.||IU/L||Standard Deviation|Mean
841300|NCT01343368|Secondary|Comparison of Luteinizing Hormone (LH) Levels|Comparison of treatment arms; interventional versus observational average LH levels during study.|Day 180|Four patients on the Observational arm never had any follow-up LH levels drawn and were removed from this analysis. One patient on the Interventional arm and 7 on the Observational arm were lost to follow-up.||IU/L||Standard Deviation|Mean
841301|NCT01343368|Secondary|Comparison of Luteinizing Hormone (LH) Levels|Comparison of treatment arms; interventional versus observational average LH levels during study.|Day 100|Four patients on the Observational arm never had any follow-up LH levels drawn and were removed from this analysis. One patient on the Interventional arm and 7 on the Observational arm were lost to follow-up.||IU/L||Standard Deviation|Mean
841302|NCT01343368|Secondary|Comparison of Lutineizing Hormone (LH) Levels|Comparison of treatment arms; interventional versus observational average LH levels during study.|Baseline|Four patients on the Observational arm never had any follow-up LH levels drawn and were removed from this analysis.||IU/L||Standard Deviation|Mean
841303|NCT01343368|Secondary|Comparison of Number of Patients Who Resumed Menstrual Cycles|Comparison of treatment arms; interventional versus observational. Count of patients who resumed menses after hematopoietic cell transplant|Day 365 Post Transplant|Only 6 of the 10 patients that started on the Observational Arm were evaluable. The 2 patients were lost to follow-up.||Participants|||Count of Participants
841304|NCT01343368|Secondary|Comparison of Follicle Stimulating Hormone (FSH) Levels|Comparison of treatment arms; interventional versus observational average FSH levels.|2 years|Four patients on the Observational arm never had any follow-up FSH levels drawn and were removed from this analysis. All 7 patients on the Interventional arm and 8 patients on the Observational arm were lost to follow-up.||IU/L||Standard Deviation|Mean
841305|NCT01343368|Secondary|Comparison of Follicle Stimulating Hormone (FSH) Levels|Comparison of treatment arms; interventional versus observational average FSH levels.|1 year|Four patients on the Observational arm never had any follow-up FSH levels drawn and were removed from this analysis. Three patients on the Interventional arm and 8 patients on the Observational arm were lost to follow-up.||IU/L||Standard Deviation|Mean
841306|NCT01343368|Secondary|Comparison of Follicle Stimulating Hormone (FSH) Levels|Comparison of treatment arms; interventional versus observational average FSH levels.|Day 180|Four patients on the Observational arm never had any follow-up FSH levels drawn and were removed from this analysis. One patient on the Interventional arm and 7 on the Observational arm were lost to follow-up.||IU/L||Standard Deviation|Mean
841307|NCT01343368|Secondary|Comparison of Follicle Stimulating Hormone (FSH) Levels|Comparison of treatment arms; interventional versus observational average FSH levels.|Day 100|Four patients on the Observational arm never had any follow-up FSH levels drawn and were removed from this analysis. One patient on the Interventional arm and 7 on the Observational arm were lost to follow-up.||IU/L||Standard Deviation|Mean
841308|NCT01343368|Secondary|Comparison of Follicle Stimulating Hormone (FSH) Levels|Comparison of treatment arms; interventional versus observational average FSH levels.|Baseline|Four patients on the Observational arm never had any follow-up FSH levels drawn and were removed from this analysis.||IU/L||Standard Deviation|Mean
841309|NCT01343368|Secondary|Comparison of Number of Patients Who Stopped Menstrual Bleeding|Comparison of treatment arms; interventional versus observational. Count of patients who stopped menstrual bleeding; to determine how the effect of GnRH agonists are at suppressing menses during hematopoietic cell transplant|From Baseline Through Day 365|Five patients on the Interventional arm and 10 patients on the Observational arm were lost to follow-up by Day 365.||Participants|||Count of Participants
841310|NCT01343368|Primary|Comparison of Number of Patients With Ovarian Failure|Comparison of treatment arms; interventional versus observational. Ovarian failure rate is based on FSH measured at 180 days after HCT; to determine the effect of GnRH agonists on the incidence of ovarian failure (i.e. FSH >40 IU/L) after transplant.|Through Day 180 Post Transplant|||Participants|||Count of Participants
841311|NCT01343485|Primary|On-time Completion of the Human Papillomavirus Vaccine Series||32 weeks after receipt of initial vaccine|||participants|||Number
841312|NCT01343667|Primary|Major Adverse Events (MAE)|Major Adverse Events include death, stroke and myocardial infarction|Onset from start of index procedure to 30-day follow-up assessment|Enrolled subjects with successful procedure and sufficient follow-up||participants|||Number
841313|NCT01343823|Secondary|Time to Symptom Resolution Based on the Visual Analog Scale (VAS)|"Compare the time to onset of symptom resolution between the ecallantide-treated and placebo-treated groups.
The patient assessed severity of the angioedema attack using a VAS at baseline and following study drug administration every 15 minutes for the first 2 hours and then every 30 minutes through 6 hours post dosing or until the time of discharge from the ER (whichever occurred first). The scale ranged from totally resolved to very severe."|6 hours|Time to Symptom Resolution Based on the VAS (Safety Population)||hours||95% Confidence Interval|Median
841314|NCT01343823|Primary|Safety and Efficacy of Ecallantide|"Compare the proportion of patients meeting prespecified discharge criteria in the group receiving ecallantide with conventional therapy to patients receiving placebo with conventional therapy.
Patients were evaluated against 6 discharge eligibility criteria at 1,2,3,4,5, and 6 hours after study drug administration or until discharged from the ER.
A responder was defined as a patient meeting all six discharge eligibility criteria as below:
Improvement of edema to “a little better” or “a lot better” as assessed by health care provider using a five point scale
Stable vital signs (within an acceptable range)
Absence of stridor
Absence of dyspnea or use of accessory muscles during respiration
Absence of drooling
Able to drink without difficulty"|6 hours|Safety Population||participants||95% Confidence Interval|Number
841332|NCT01343901|Secondary|Percentage of Participants Who Died||Baseline until death; assessed up to 36 months|Efficacy population||Percentage of participants|||Number
841315|NCT01343888|Secondary|Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO|This will be presented as the number of patients. BL = Baseline|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.||participants|||Number
841316|NCT01343888|Secondary|Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES|This will be presented as the number of patients. BL = Baseline|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.||participants|||Number
841317|NCT01343888|Secondary|Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EoT) When SVR12=NO|This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.||participants|||Number
841318|NCT01343888|Secondary|Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EoT) When SVR12=YES|This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.||participants|||Number
841319|NCT01343888|Secondary|Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO|This will be presented as the number of patients. BL = Baseline|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.||participants|||Number
841320|NCT01343888|Secondary|Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES|This will be presented as the number of patients. BL = Baseline|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.||participants|||Number
841321|NCT01343888|Secondary|Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EoT) When SVR12= NO|This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.||participants|||Number
841322|NCT01343888|Secondary|Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EoT) When SVR12=YES|This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.||participants|||Number
841323|NCT01343888|Secondary|Early Treatment Success (ETS)|Early treatment success (ETS), defined as a plasma HCV RNA level <25 IU/mL (detected or undetected) at week 4 and HCV RNA <25 IU/mL (undetected) at week 8.|week 4 and week 8|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.||percentage of participants|||Number
841324|NCT01343888|Secondary|Sustained Virological Response 24 Weeks Post-treatment (SVR24)|Sustained Virological Response 24 weeks post-treatment (SVR24), defined as plasma HCV RNA level < 25 IU/mL (undetected) 24 weeks after the originally planned treatment duration.|24 weeks post treatment, up to 72 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.||percentage of participants||95% Confidence Interval|Number
841325|NCT01343888|Primary|Sustained Virological Response 12 Weeks Post-treatment (SVR12)|Sustained Virological Response 12 weeks post-treatment (SVR12), defined as plasma Hepatitis C virus (HCV) Ribonucleic acid (RNA) level < 25 IU/mL (undetected) 12 weeks after the originally planned treatment duration.|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.||percentage of participants||95% Confidence Interval|Number
841326|NCT01343901|Secondary|Percentage of Participants With Unresectability Criteria||Day 0|Efficacy population. Here number of participants analyzed represents the number of participants evaluable for this outcome measure.||Percentage of participants|||Number
841327|NCT01343901|Secondary|Total Duration of First Line Bevacizumab Treatment at Day 0||Day 0|Efficacy population. Here number of participants analyzed represents the number of participants evaluable for this outcome measure.||months||Full Range|Median
841328|NCT01343901|Secondary|Percentage of Participants With Different Doses of First Line Bevacizumab at Day 0||Day 0|Efficacy population. Here, number of participants analyzed represents the number of participants evaluable for this outcome measure.||Percentage of participants|||Number
841329|NCT01343901|Secondary|Number of Cumulated Cycles of First Line Bevacizumab at Day 0||Day 0|Efficacy population. Here number of participants analyzed represents the number of participants evaluable for this outcome measure.||cycles||Standard Deviation|Mean
841330|NCT01343901|Secondary|Percentage of Participants With Histologically Viable Tumor Cells With Resected Non Detectable Hepatic and Pulmonary Metastases Post Surgery|For the non-detectable liver and lung metastases the categorization based on rate of viable cells were as follows (no viable cells =0%, minimum =1 to 49%, maximum =50 to 100%).|Baseline up to 36 months|Efficacy population. Here number of participants analyzed represents the overall number of participants evaluable for this outcome and ‘n’ represents the number of participants available for assessment at a given category.||Percentage of participants|||Number
841331|NCT01343901|Secondary|Overall Survival (OS)|OS time is defined as time between start of therapy and date of death. Kaplan-Meier estimate was used for evaluation.|Baseline until death, assessed up to 36 months|Efficacy population||months||95% Confidence Interval|Median
841333|NCT01343901|Secondary|Relapse-free Survival (RFS)|RFS was defined as the time elapsed between the last surgery removing all detectable metastases (A1 criterion [participants without DMD after secondary resection removing all detectable metastases at surgery {including participants with missing metastases}]) and the date of first PD or death. PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions, or appearance of one or more new lesions.|Baseline until disease progression or death, whichever occurred first, assessed up to 36 months|Efficacy population. Here number of participants analyzed signifies efficacy population with surgery removing all the detectable metastases.||Months||95% Confidence Interval|Median
841334|NCT01343901|Secondary|Percentage of Participants With Disease Relapse|Relapse was defined as the presence of metastases post last surgery removing all detectable metastases (A1 criterion [participants without detectable metastatic disease {DMD} after secondary resection removing all detectable metastases at surgery {including participants with missing metastases}]) and the date of first PD or death. PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions, or appearance of one or more new lesions.|Baseline until disease progression or death, whichever occurred first, assessed up to 36 months|Efficacy population. Here number of participants analyzed signifies efficacy population with surgery removing all the detectable metastases.||Percentage of participants|||Number
841335|NCT01343901|Secondary|Progression-free Survival (PFS)|Progression-free survival defined as the time elapsed between the Avastin start date and the date of first progressive disease (PD) or death. Kaplan-Meier estimate was used for evaluation. PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions or appearance of one or more new lesions.|Baseline until disease progression or death, whichever occurred first, assessed up to 36 months|Efficacy population.||Months||95% Confidence Interval|Median
841336|NCT01343901|Secondary|Percentage of Participants With Disease Progression or Death|Disease progression is defined at least a 20 percent (%) increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 millimeter (mm) or persistence of non-target lesions, or appearance of one or more new lesions.|Baseline until disease progression or death, whichever occurred first, assessed up to 36 months|Efficacy population||Percentage of participants|||Number
841337|NCT01343901|Secondary|Percentage of Participants With at Least One Comorbidity Post Bevacizumab Treatment|Percentage of participants who had any concurrent disease (comorbidity) was reported. Comorbidities included gastrointestinal disease, other cardiovascular disease, and other medical history and comorbidities (other than those which are specified above). Same participant may be counted in more than one category.|Baseline up to 36 months|Analysis population consisted of participants with disappeared metastasis left in place with or without surgery. Here number of participants analyzed represents the number of participants evaluable for this outcome and ‘n’ represents the number of participants available for assessment at a given category.||Percentage of participants|||Number
841338|NCT01343901|Secondary|Percentage of Participants Who Received at Least One Chemotherapy Over the Study Period||Baseline up to 36 months|Efficacy population. Here number of participants analyzed represents the number of participants evaluable for this outcome measure.||Percentage of participants|||Number
841339|NCT01343901|Secondary|Mean Number of Cumulated Cycles of Bevacizumab Over the Study Period||Baseline up to 36 months|Efficacy population. Here number of participants analyzed represents the number of participants evaluable for this outcome measure.||Cycles||Standard Deviation|Mean
841340|NCT01343901|Secondary|Percentage of Participants With Different Previous Therapies at Day 0|Previous therapies included neoadjuvant treatment (chemotherapy or chemotherapy + radiotherapy) and adjuvant treatment (FOLFOX [folinic acid+5-fluorouracil+oxaliplatin], LV5FU2 [leucovorin+5-Fluorouracil], capecitabine, or any other adjuvant treatment). Only participants who received neoadjuvant treatment and adjuvant treatment was reported.|Day 0|Efficacy population. Here number of participants analysed represents the number of participants evaluable for this outcome measure.||Percentage of participants|||Number
841341|NCT01343901|Secondary|Percentage of Participants With at Least One Disease and Comorbidity at Day 0|Percentage of participants who had any concurrent disease (comorbidity) at Day 0 was reported. Comorbidities included gastrointestinal disease, hypertension, other cardiovascular disease, and other medical history and comorbidities (other than those specified above). Same participant may be counted in more than one category.|Day 0|Efficacy population. Here number of participants analyzed represents the number of participants evaluable for this outcome and ‘n’ represents the number of participants available for assessment at a given category.||Percentage of participants|||Number
841342|NCT01343901|Primary|Percentage of Participants Without Detectable Metastatic Disease After a Complete Response Without Surgery|The percentage of participants with no detectable metastatic disease after a complete response without surgery (missing metastasis) was reported.|Baseline up to 36 months|Efficacy population. Here number of participants analyzed represents the number of participants evaluable for this outcome measure.||Percentage of participants|||Number
841343|NCT01343901|Primary|Percentage of Participants Without Detectable Metastatic Disease After Secondary Resection Post Surgery|Secondary resection involves removal of all detectable metastases at surgery including participants with missing metastases left in place. Percentage of participants without detectable metastatic disease after secondary resection removing all detectable metastases at surgery (including participants with disappeared metastases left in place [missing metastases]) was reported. Metastases was detected using computed tomography (CT) scan or magnetic resonance imaging (MRI).|Baseline up to 36 months|Efficacy population. Here number of participants analyzed represents the number of participants evaluable for this outcome measure.||Percentage of participants|||Number
841344|NCT01344057|Primary|Percentage of Participants Who Achieved SRH Area ≥25mm2 Against Each of the Three Vaccine Strains After One Vaccination of FLUAD|"Immunogenicity was measured as the percentage of participants achieving SRH area ≥25 mm2 against each of the three vaccine strains at baseline (day 1) and three weeks after FLUAD vaccination (day 22).
This criterion is met according to CHMP guideline if percentage of participants achieving SRH area ≥25 mm2 is 60% (≥65 years)."|day 22|Analysis was done using PP set.||Percentage of participants||95% Confidence Interval|Number
841345|NCT01344057|Primary|Geometric Mean Ratio of Participants Against Each of the Three Vaccine Strains After One Vaccination of FLUAD|"Geometric mean ratio (GMR) of participants was calculated as the ratio of post-vaccination to pre-vaccination SRH geometric mean areas (GMAs), directed against each of the three vaccine strains, three weeks after FLUAD vaccination (day 22).
The CHMP criterion was met if the geometric mean increase (GMR, day 22/day 1) in SRH antibody area is >2.0 (≥65 years)."|day 22|Analysis was done using PP set.||Ratio||95% Confidence Interval|Geometric Mean
841346|NCT01344057|Secondary|Number of Participants Who Reported Solicited Local and Systemic Reactions|Safety was assessed for participants who reported solicited local and systemic reactions from day 1 up to and including day 4 after the FLUAD vaccination.|1 to 4 days post-vaccination|Analysis was done using the safety dataset; participants who received study vaccination and who provided post-vaccination safety data.||Number of participants|||Number
841347|NCT01344057|Primary|Percentage of Participants Who Achieved Seroconversion or Significant Increase in Single Radial Hemolysis (SRH) Area Against Each of Three Vaccine Strains After One Vaccination of FLUAD|"Immunogenicity was measured as the percentage of participants who achieved seroconversion or significant increase in single radial hemolysis (SRH) area, against each of the three vaccine strains, three weeks after vaccination (day 22), evaluated using SRH assay.
Seroconversion: proportion of participants with negative pre-vaccination serum and a post-vaccination serum area ≥ 25 mm2. Significant increase: proportion of participants with at least a 50% increase in area from positive pre-vaccination serum. Seroconversion or significant increase: proportion of participants with either seroconversion or significant increase.
The European (Committee for Medicinal Products for Human Use [CHMP]) criterion is met, if percentage of participants achieving seroconversion or significant increase in SRH area is 30% (≥65 years)."|day 22|Per protocol (PP) analysis set included all enrolled participants who had correctly received the vaccine, provided evaluable serum samples before and after vaccination, and had no major protocol violations.||Percentage of participants||95% Confidence Interval|Number
841348|NCT01344161|Primary|Change in Insulin Concentrations||3 months minus baseline|||pmol/L||Standard Deviation|Mean
841349|NCT01344161|Primary|Change in Post Load Glucose Concentrations|It was performed 2 hours after 75g oral glucose tolerance test (75-OGTT).|3 months minus baseline|||mmol/L||Standard Deviation|Mean
841350|NCT01344161|Primary|Change in Glucose Concentrations||3 months minus baseline|||mmol/L||Standard Deviation|Mean
841351|NCT01344161|Primary|Change in Body Fat Mass|Body composition was assessed by Bioelectrical Impedance Analysis (model 4000; Body Stat Quad Scan, Douglas Isle of Man, British Isles).The principle of measuring the flow of current through the body is dependent on the frequency applied. At low frequencies, the current cannot bridge the cellular membrane and will pass predominantly through the extra-cellular space. At higher frequencies penetration of the cell membrane occurs and the current is conducted by both the extra-cellular water (ECW) and intra-cellular water (ICW).FFM can be estimated because FFM is primarily composed of water.|3 months minus baseline|We assessed body composition by Bioelectrical Impedance Analysis (model 4000; Body Stat Quad Scan, Douglas Isle of Man, British Isles).||kg||Standard Deviation|Mean
841352|NCT01344369|Primary|AUC0-inf of Ethinyl Estradiol|Bioequivalence based on Ethinyl Estradiol AUC0-inf (area under the concentration-time curve from time zero to infinity).|Blood samples collected over a 60 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
841353|NCT01344369|Primary|AUC0-t of Ethinyl Estradiol|Bioequivalence based on Ethinyl Estradiol AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).|Blood samples collected over a 60 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
841354|NCT01344369|Primary|Cmax of Ethinyl Estradiol|Bioequivalence based on Ethinyl Estradiol Cmax (maximum observed concentration of drug substance in plasma).|Blood samples collected over a 60 hour period.|All participants that completed the study had their samples analyzed.||pg/mL||Standard Deviation|Mean
841355|NCT01344369|Primary|AUC0-inf of Norethindrone|Bioequivalence based on Norethindrone AUC0-inf (area under the concentration-time curve from time zero to infinity).|Blood samples collected over a 60 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
841356|NCT01344369|Primary|AUC0-t of Norethindrone|Bioequivalence based on Norethindrone AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).|Blood samples collected over a 60 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
841357|NCT01344369|Primary|Cmax of Norethindrone|Bioequivalence based on Norethindrone Cmax (maximum observed concentration of drug substance in plasma).|Blood samples collected over a 60 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
841358|NCT01344447|Secondary|Types of Additional Imaging Studies Recommended by the Clinical Investigator After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images|An additional imaging study recommended was specified from the following list: Non-contrast MRA, Contrast-enhanced MRA, CTA, Ultrasound, Digital subtraction catheter angiogram (DSCA), and Nuclear medicine study.|Images were taken pre-injection and post-injection|Participants in FAS who were recommended for additional imaging studies.||participants|||Number
841359|NCT01344447|Secondary|Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images – Blinded Reader 3|An additional imaging study recommended was specified from the following list: Non-contrast MRA, Contrast-enhanced MRA, CTA, Ultrasound, Digital subtraction catheter angiogram (DSCA), and Nuclear medicine study.|Images were taken pre-injection and post-injection|Participants in FAS who were recommended for additional imaging studies.||participants|||Number
841360|NCT01344447|Secondary|Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images – Blinded Reader 2|An additional imaging study recommended was specified from the following list: Non-contrast MRA, Contrast-enhanced MRA, CTA, Ultrasound, Digital subtraction catheter angiogram (DSCA), and Nuclear medicine study.|Images were taken pre-injection and post-injection|Participants in FAS who were recommended for additional imaging studies.||participants|||Number
841361|NCT01344447|Secondary|Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images – Blinded Reader 1|An additional imaging study recommended was specified from the following list: Non-contrast MRA, Contrast-enhanced MRA, CTA, Ultrasound, Digital subtraction catheter angiogram (DSCA), and Nuclear medicine study.|Images were taken pre-injection and post-injection|Participants in FAS who were recommended for additional imaging studies.||participants|||Number
841362|NCT01344447|Secondary|The Percentage of Participants With Additional Imaging Studies Recommended by the Blinded Readers and the Clinical Investigator After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images|A measure of diagnostic value was the reduction in the number of additional diagnostic imaging studies recommended/ordered. The clinical investigators and the blinded readers were asked if they would have recommended an additional imaging study for each participant and was recorded.|Images were taken pre-injection and post-injection|FAS||percentage of participants|||Number
841363|NCT01344447|Secondary|Diagnostic Confidence by the Blinded Readers Using Gadobutrol-Enhanced MRA and Unenhanced MRA|Diagnostic confidence was evaluated to determine the level of certainty that the blinded readers assigned to a diagnosis for each segment. This was defined as the degree of confidence that the information on the MRA images represented the true and complete clinical picture of a particular segment. The degree of confidence was rated on a 4-point scale: 1 = Not confident, 2 = Somewhat confident, 3 = Confident, and 4 = Very confident.|Images were taken pre-injection and post-injection|"Evaluable participants in FAS; this outcome measure was analyzed on a segment basis, in below table, n signifies number of segments that were evaluable for the specified category of each group."||units on a scale||Standard Deviation|Mean
841364|NCT01344447|Secondary|Type of Secondary Radiologic Indicators for Diagnosis of Clinically Relevant Disease|Each segment was assessed for secondary signs of stenosis for diagnosis of clinically significant disease. The following indicators were considered for the MRA studies: - post-stenotic dilation or ulceration (segmental), - post-stenotic signal dropout, narrowing and intensity reduction, and - thrombus. Each of the three parameters were assessed as present or absent in the region distal to the stenosis. If they were found in any segment distal to the stenosis then they were assessed as present. If there were tandem (serial) stenosis in a vessel then the secondary signs were assigned to the stenosis of >=70% that was proximal and closest in proximity to the secondary sign.|Images were taken pre-injection and post-injection|"Evaluable participants in FAS; this outcome measure was analyzed on a segment basis, in below table, n signifies number of segments with presence of secondary radiologic indicators for the specified category of each group."||percentage of segments|||Number
841365|NCT01344447|Secondary|The Percentage of Presence of Secondary Radiologic Indicators for Diagnosis of Clinically Relevant Disease|Each segment was assessed for secondary signs of stenosis for diagnosis of clinically significant disease. The following indicators were considered for the MRA studies: - post-stenotic dilation or ulceration (segmental), - post-stenotic signal dropout, narrowing and intensity reduction, and - thrombus. Each of the three parameters were assessed as present or absent in the region distal to the stenosis. If they were found in any segment distal to the stenosis then they were assessed as present.|Images were taken pre-injection and post-injection|"Evaluable participants in FAS; this outcome measure was analyzed on a segment basis, in below table, n signifies segments that were evaluable for the specified category of each group."||percentage of radiologic indicator|||Number
841366|NCT01344447|Secondary|Length of Stenosis (>=70%) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA|The length of stenosis was based on the most proximal (first point) in a segment where a stenosis exceeded 10% and the most distal point (last point) in the segment where a stenosis exceeded 10%. If a stenosis spanned more than one segment then the measurement was only included to the beginning or end (boundary) of the segment being evaluated. If there was no stenosis of >=70% in a segment then the length was designated as 0.|Images were taken pre-injection and post-injection|"Evaluable participants in FAS; this outcome measure was analyzed on a segment basis, in the below table, n signifies number of segments that were evaluable for the specified category of each group."||millimeter(s)||Standard Deviation|Mean
841367|NCT01344447|Secondary|The Percentage of Location of Stenosis (>=70%) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA|Location within a segment was based on the point of greatest stenosis and was recorded for stenosis >=70% (including occlusions) as: - At the bifurcation or proximal origin of a segment (occlusion proximal to the origin of the segment); - Within 5 mm of the bifurcation or proximal origin of a segment; - Beyond 5 mm from the bifurcation or proximal origin of a segment.|Images were taken pre-injection and post-injection|"Evaluable participants in FAS; in the below table, n signifies number of locations that were evaluable for the specified category of each group."||pecentage of location|||Number
841368|NCT01344447|Secondary|Types of Artifacts on a Segment Basis by Blinded Reader 3|The following types of artifacts were considered: Motion artifact (including pulsatility, breathing, swallowing), venous opacification, saturation artifact (for example [eg], in-plane flow, turbulence, dephasing, saturation band), susceptibility artifacts (including devices, eg, stents), ringing artifact (eg, bands), bolus timing error, and other (artifact not specified above or no artifact).|Images were taken pre-injection and post-injection|Participants in FAS with artifacts presence.||percentage of segments|Participants||Number
841369|NCT01344447|Secondary|Types of Artifacts on a Segment Basis by Blinded Reader 2|The following types of artifacts were considered: Motion artifact (including pulsatility, breathing, swallowing), venous opacification, saturation artifact (for example [eg], in-plane flow, turbulence, dephasing, saturation band), susceptibility artifacts (including devices, eg, stents), ringing artifact (eg, bands), bolus timing error, and other (artifact not specified above or no artifact).|Images were taken pre-injection and post-injection|Participants in FAS with artifacts presence.||percentage of segments|Participants||Number
841370|NCT01344447|Secondary|Types of Artifacts on a Segment Basis by Blinded Reader 1|The following types of artifacts were considered: Motion artifact (including pulsatility, breathing, swallowing), venous opacification, saturation artifact (for example [eg], in-plane flow, turbulence, dephasing, saturation band), susceptibility artifacts (including devices, eg, stents), ringing artifact (eg, bands), bolus timing error, and other (artifact not specified above or no artifact).|Images were taken pre-injection and post-injection|Participants in FAS with artifacts presence.||percentage of segments|Participants||Number
841371|NCT01344447|Secondary|The Percentage of Segments With Artifacts Presence|Artifacts were collected for the MRA images on a segmental basis.|Images were taken pre-injection and post-injection|Evaluable participants in FAS||percentage of segments|Participants||Number
841372|NCT01344447|Secondary|Vessel Diameter (Millimeter [mm]) at the Normal Point and the Narrowest Point in Gadobutrol-Enhanced MRA, Unenhanced MRA and CTA Images|The segment reduction in diameter (DIA) of greater than 10% was considered abnormal and measured. The diameter of each of these abnormal segments was measured using electronic calipers (perpendicular to the long axis of the vessel) at the point of most severe stenosis within each segment. Mean of vessel diameters was calculated by segment separately for CTA and MRA readers. For ease of expression, the following abbreviations will be used: Diameter (DIA), Blinded Reader (BR), Clinical Investigator (CI).|Images were taken pre-injection and post-injection|FAS; Number of participants/segments analyzed in below ordered categories (Normal-BRs; Narrowest-BRs; Normal-CIs; Narrowest-CIs) in Enhanced MRA group was 457/6182, 457/6182, 419/1361, 419/1352 respectively; in Unenhanced MRA group was 455/4776, 455/4776, 367/989, 367/980 respectively; in CTA was 442/3158, 442/3158, 419/1569, 419/1555 respectively.||millimeter(s) (mm)||Standard Deviation|Mean
841373|NCT01344447|Primary|Minimum Gadobutrol Performance for Specificity: Specificity > 50%|Clinically significant disease was defined as 70 to 99% stenosis of a segment, but not occluded as assessed by the SoR (CTA; blinded readers). For each segment, the most severe stenosis/narrowing was identified and considered for the evaluation of clinically significant disease. Gadobutrol minimum performance criteria was based on a stenosis of 50% calculated from the native vessel diameter.|Images were taken pre-injection and post-injection|"FAS; in below table, n/n signifies the number of participants/segments that were evaluable in specified category."||percentage of specificity|Participants||Number
841374|NCT01344447|Primary|Minimum Gadobutrol Performance for Sensitivity: Sensitivity > 50%|Clinically significant disease was defined as 70 to 99% stenosis of a segment, but not occluded as assessed by the SoR (CTA; blinded readers). For each segment, the most severe stenosis/narrowing was identified and considered for the evaluation of clinically significant disease. Gadobutrol minimum performance criteria was based on a stenosis of 50% calculated from the native vessel diameter.|Images were taken pre-injection and post-injection|"FAS; in below table, n/n signifies the number of participants/segments that were evaluable in specified category."||percentage of sensitivity|Participants||Number
841375|NCT01344447|Primary|Specificity for Exclusion of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA|Clinically significant disease was defined as 70 to 99% stenosis of a segment, but not occluded, as assessed by the SoR (CTA; blinded readers). This was determined using the NASCET criteria. For each segment, the most severe stenosis/narrowing was identified and considered for the evaluation of clinically significant disease. In case of multiple stenosis in any one segment, the most severe stenosis in the segment was recorded.|Images were taken pre-injection and post-injection|"FAS; in below table, n/n signifies the number of participants/segments that were evaluable in specified category of each group if it varies from Number of participants/segments analyzed."||percentage of specificity|Participants||Number
841376|NCT01344447|Primary|Sensitivity for Detection of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA|Clinically significant disease was defined as 70 to 99% stenosis of a segment, but not occluded, as assessed by the standard of reference (SoR) (computed tomographic angiography [CTA]; blinded readers). This was determined using the North American Symptomatic Carotid Endarterectomy Trial (NASCET) criteria. For each segment, the most severe stenosis/narrowing was identified and considered for the evaluation of clinically significant disease. In case of multiple stenosis in any one segment, the most severe stenosis in the segment was recorded.|Images were taken pre-injection and post-injection|"FAS; in below table, n/n signifies the number of participants/segments that were evaluable in specified category of each group."||percentage of sensitivity|Participants||Number
841377|NCT01344447|Primary|Percentage of Assessable Vascular Segments Using Gadobutrol-Enhanced MRA and Unenhanced MRA|Each vascular segment was visualized using unenhanced MRA and gadobutrol-enhanced MRA, characterized by the on-site investigators, three independent blinded readers (BR) (BR 1, BR 2 and BR 3) and majority readers (the outcome determined by at least two of the blinded readers). A segment was assessable if it was visualized along its entire length and if any region of stenosis, was measured reliably. There were 21 segments of the supra-aortic arteries assessed per participant.|Images were taken pre-injection and post-injection|FAS||percentage of segments|Participants||Number
841378|NCT01344460|Secondary|Types of Additional Imaging Studies Recommended by the Clinical Investigator After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images|An additional imaging study recommended was specified from the following list: Non-contrast MRA, Contrast-enhanced MRA, CTA, Ultrasound, Digital subtraction catheter angiogram (DSCA), and Nuclear medicine study.|Images were taken pre-injection and post-injection|FAS with participants who were recommended for additional imaging studies.||participants|||Number
841379|NCT01344460|Secondary|Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Gadobutrol-Enhanced and Unenhanced MRA Images – Blinded Reader 3|An additional imaging study recommended was specified from the following list: Non-contrast MRA, Contrast-enhanced MRA, CTA, Ultrasound, Digital subtraction catheter angiogram (DSCA), and Nuclear medicine study.|Images were taken pre-injection and post-injection|FAS with participants who were recommended for additional imaging studies.||participants|||Number
841380|NCT01344460|Secondary|Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Gadobutrol-Enhanced and Unenhanced MRA Images – Blinded Reader 2|An additional imaging study recommended was specified from the following list: Non-contrast MRA, Contrast-enhanced MRA, CTA, Ultrasound, Digital subtraction catheter angiogram (DSCA), and Nuclear medicine study.|Images were taken pre-injection and post-injection|FAS with participants who were recommended for additional imaging studies.||participants|||Number
841381|NCT01344460|Secondary|Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Gadobutrol-Enhanced and Unenhanced MRA Images – Blinded Reader 1|An additional imaging study recommended was specified from the following list: Non-contrast MRA, Contrast-enhanced MRA, CTA, Ultrasound, Digital subtraction catheter angiogram (DSCA), and Nuclear medicine study.|Images were taken pre-injection and post-injection|FAS with participants who were recommended for additional imaging studies.||participants|||Number
841407|NCT01339052|Secondary|Grade 3-5 Treatment-Related Toxicity Rate|The percentage of patients who experienced any grade 3-5 treatment-related adverse event based on CTCAEv4 as reported on case report forms.|Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.|The analysis dataset is comprised of all treated patients.||percentage of patients||90% Confidence Interval|Number
841382|NCT01344460|Secondary|The Percentage of Participants With Additional Imaging Studies Recommended by the Blinded Readers and the Clinical Investigator After Evaluation of the Gadobutrol-Enhanced and Unenhanced MRA Images|A measure of diagnostic value was the reduction in the number of additional diagnostic imaging studies recommended/ordered. The clinical investigators and the blinded readers were asked if they had recommended an additional imaging study for each participant, and the data were recorded.|Images were taken pre-injection and post-injection|FAS||percentage of participants|||Number
841383|NCT01344460|Secondary|Diagnostic Confidence by the Blinded Readers Using Gadobutrol-Enhanced MRA and Unenhanced MRA|Diagnostic confidence was evaluated to determine the level of certainty that the blinded readers assigned to a diagnosis for each segment. This was defined as the degree of confidence that the information on the MRA images represented the true and complete clinical picture of a particular segment. The degree of confidence was rated on a 4-point scale: 1=Not confident; 2=Somewhat confident; 3=Confident; 4=Very confident.|Images were taken pre-injection and post-injection|"FAS; In the below table, n signifies the number of segments that were evaluable in specified category."||Units on scale||Standard Deviation|Mean
841384|NCT01344460|Secondary|The Percentage of Participants With Diagnosis of Fibromuscular Dysplasia and Arteriosclerosis Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA|Any focal dilatation (aneurysmal dilatation) of a segment was recorded. The diameter at the widest point was measured with the electronic calipers if a dilatation was present in any segment. The number of participants with an aneurysmal dilatation in each segment (proximal, mid- and distal) in the right and the left renal arteries assessed by gadobutrol-enhanced MRA and unenhanced MRA were reported.|Images were taken pre-injection and post-injection|FAS||percentage of participants|||Number
841385|NCT01344460|Secondary|The Presence of Any Aneurysmal Dilatation in Each Segment (Proximal, Mid- and Distal) in the Right and the Left Renal Arteries Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA|Any focal dilatation (aneurysmal dilatation) of a segment was recorded. The diameter at the widest point was measured with the electronic calipers if a dilatation was present in any segment. The number of participants with an aneurysmal dilatation in each segment (proximal, mid- and distal) in the right and the left renal arteries assessed by gadobutrol-enhanced MRA and unenhanced MRA were reported.|Images were taken pre-injection and post-injection|FAS||percentage of participants|||Number
841386|NCT01344460|Secondary|The Percentage of Accessory (Non-dominant) Renal Artery Presence Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA|An accessory renal artery was defined as an additional, non-dominant, renal artery typically emanating from the aorta and anastomosing distal to the proximal third, segment of that renal artery. It was recorded only as present or absent on the right and left, regardless of how many accessory renal arteries were present.|Images were taken pre-injection and post-injection|FAS||percentage of accessory|||Number
841387|NCT01344460|Secondary|Types of Artifacts Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA by Blinded Reader 3|The following types of artifacts were considered: Motion artifact (including pulsatility, breathing, swallowing), venous opacification, saturation artifact (for example [eg], in-plane flow, turbulence, dephasing, saturation band), susceptibility artifacts (including devices, eg, stents), ringing artifact (eg, bands), bolus timing error, and other (artifact not specified above or no artifact).|Images were taken pre-injection and post-injection|Participants in FAS with artifacts presence.||percentage of segments|||Number
841388|NCT01344460|Secondary|Types of Artifacts Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA by Blinded Reader 2|The following types of artifacts were considered: Motion artifact (including pulsatility, breathing, swallowing), venous opacification, saturation artifact (for example [eg], in-plane flow, turbulence, dephasing, saturation band), susceptibility artifacts (including devices, eg, stents), ringing artifact (eg, bands), bolus timing error, and other (artifact not specified above or no artifact).|Images were taken pre-injection and post-injection|Participants in FAS with artifacts presence.||percentage of segments|||Number
841389|NCT01344460|Secondary|Types of Artifacts Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA by Blinded Reader 1|The following types of artifacts were considered: Motion artifact (including pulsatility, breathing, swallowing), venous opacification, saturation artifact (for example [eg], in-plane flow, turbulence, dephasing, saturation band), susceptibility artifacts (including devices, eg, stents), ringing artifact (eg, bands), bolus timing error, and other (artifact not specified above or no artifact).|Images were taken pre-injection and post-injection|Participants in FAS with artifact presence.||percentage of segments|||Number
841390|NCT01344460|Secondary|The Percentage of Segments With Artifacts Presence|Artifacts were collected for the MRA images on a segmental basis.|Images were taken pre-injection and post-injection|Evaluable participants in FAS||percentage of segments|||Number
841391|NCT01344460|Secondary|The Percentage of Location of Stenosis >= 50% (Within and Beyond 5 Millimeter From the Aorta) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA|Location within the right and left proximal segment was based on the point of greatest stenosis and was recorded for stenosis >=50% as: - Within 5 mm of the aorta (or occlusion proximal to the origin of the segment); - Beyond 5 mm from the aorta.|Images were taken pre-injection and post-injection|"Participants in FAS that were evaluable; in below table, n signifies the number of segments that were evaluable in specified category."||Percentage of location|||Number
841392|NCT01344460|Secondary|Vessel Diameter (Millimeter [mm]) at the Normal Point and the Narrowest Point in Gadobutrol-Enhanced MRA, Unenhanced MRA and CTA Images|The segment reduction in diameter (DIA) of greater than 10% was considered abnormal and measured. The diameter of each of these abnormal segments was measured using electronic calipers (perpendicular to the long axis of the vessel) at the point of most severe stenosis within each segment. Mean of vessel diameters was calculated by segment separately for CTA and MRA readers. For the ease of expression, the following abbreviations will be used: Diameter (DIA), Blinded Reader (BR).|Images were taken pre-injection and post-injection|Evaluable participants in FAS||mm|Participants|Standard Deviation|Mean
841393|NCT01344460|Secondary|Length of the Right and Left Renal Arteries Assessed by Computed Tomographic Angiography (CTA) - Blinded Reader|The length of the left and right renal arteries were measured from the origin at the aorta to the bifurcation into the upper and lower pole arteries or the most distal point of the renal artery which could be visualized. This distal margin was the point where the diameter was still assessable. If there were more than 2 distal branches then the first large branch that was the dominant supply to a renal pole was used as the distal point.|Images were taken pre-injection and post-injection|Evaluable participants in FAS||millimeter(s) (mm)||Standard Deviation|Mean
841394|NCT01344460|Secondary|Length of the Right and Left Renal Arteries Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA - Blinded Reader|The length of the left and right renal arteries were measured from the origin at the aorta to the bifurcation into the upper and lower pole arteries or the most distal point of the renal artery which could be visualized. This distal margin was the point where the diameter was still assessable. If there were more than 2 distal branches then the first large branch that was the dominant supply to a renal pole was used as the distal point.|Images were taken pre-injection and post-injection|Evaluable participants in FAS||millimeter(s) (mm)||Standard Deviation|Mean
841395|NCT01344460|Primary|Minimum Gadobutrol Performance for Specificity: Specificity > 50%|Clinically significant disease (stenosis) was defined as >50% stenosis of a segment, but not occluded as assessed by the SoR. For each segment, the most severe stenosis/narrowing was identified and considered for the evaluation of clinically significant disease. Gadobutrol minimum performance criteria was based on a stenosis of 50% calculated from the native vessel diameter.|Images were taken pre-injection and post-injection|"FAS; in below table, n/n signifies the number of participants/segments that were evaluable in specified category."||percentage of specificity|Participants||Number
841396|NCT01344460|Primary|Minimum Gadobutrol Performance for Sensitivity: Sensitivity More Than (>) 50%|Clinically significant disease was defined as >50% stenosis of a segment, but not occluded as assessed by the SoR. For each segment, the most severe stenosis/narrowing was identified and considered for the evaluation of clinically significant disease. Gadobutrol minimum performance criteria was based on a stenosis of 50% calculated from the native vessel diameter.|Images were taken pre-injection and post-injection|"FAS; in below table, n/n signifies the number of participants/segments that were evaluable in specified category."||percentage of sensitivity|Participants||Number
841397|NCT01344460|Primary|Specificity for Exclusion of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA|Clinically significant disease (stenosis) was defined as 50 to 99 percent (%) stenosis of a segment, but not occluded as assessed by the SoR. For each segment, the most severe stenosis/narrowing was identified and considered for the evaluation of clinically significant disease. Specificity = percentage of participants for which the imaging modalities (unenhanced or gadobutrol-enhanced) in the detection and exclusion of clinically significant stenosis.|Images were taken pre-injection and post-injection|"FAS; in below table, n/n signifies the number of participants/segments that were evaluable in specified category."||percentage of specificity|Participants||Number
841398|NCT01344460|Primary|Sensitivity for Detection of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA|Clinically significant disease was defined as 50 to 99 percent (%) stenosis of a segment, but not occluded as assessed by the SoR. For each segment, the most severe stenosis/narrowing was identified and considered for the evaluation of clinically significant disease.|Images were taken pre-injection and post-injection|"FAS; in below table, n/n signifies the number of participants/segments that were evaluable in specified category."||percentage of sensitivity|Participants||Number
841399|NCT01344460|Primary|Percentage of Assessable Vascular Segments Using Gadobutrol-Enhanced MRA and Unenhanced MRA|Each vascular segment was visualized using unenhanced MRA and gadobutrol-enhanced MRA, characterized by the on-site investigators, three independent blinded readers (reader 1, 2 and 3) and majority readers (the outcome determined by at least two of the blinded readers). The segments were predefined to standardize the blinded reader evaluations. A segment was assessable if it was visualized along its entire length and if any region of stenosis, was measured reliably. There were 6 segments assessed per participant (3 segments in the right renal artery and 3 segments in the left renal artery) and up to 9 segments in participants with renal transplant.|Images were taken pre-injection and post-injection|"FAS; in below table, n/n signifies the number of participants/segments that were evaluable in specified category for both groups."||Percentage of segments|Participants||Number
841400|NCT01344538|Primary|Evaluate Whether 2.0g of Ginger Taken Daily, Standardized to 5%-Gingerols for Four Weeks Will Result in Bioactive Levels in Colonic Tissue Sufficient to Reduce Mucosal Prostaglandin E2 (PGE2), a Marker of Cyclooxygenase Function Versus Placebo.|% Change between baseline and day 28 in PGE2 levels standardized by protein|Baseline and day 28|||percentage of change from baseline||Standard Deviation|Mean
841401|NCT01339000|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|12 months|||participants|||Number
841402|NCT01339000|Secondary|Based on the First Two Primary Objectives, Consider and Discuss the Need for Larger Studies to Evaluate the Potential Benefit of Interleukin-7 (CYT107) Administration in a Broad, Mass Protection Strategy for an Aging Population||1 year|Insufficient data was collected for any analysis to take place. The study was closed due to lack of drug supply.|||||
841403|NCT01339000|Secondary|Evaluate the Effects of Interleukin-7 (CYT107) Therapy on the Quality of T Cell Specific Responses by Multiparameter Flow Cytometry||8 weeks|Insufficient data was collected for any analysis to take place. The study was closed due to lack of drug supply.|||||
841404|NCT01339000|Secondary|Evaluate and Quantify the Impact of Interleukin-7 (CYT107) Therapy on the T Cell Receptor Diversity in Older Subjects Following Chemotherapy||10 weeks|Insufficient data was collected for any analysis to take place. The study was closed due to lack of drug supply.|||||
841405|NCT01339000|Primary|Evaluate and Quantify the Impact of Interleukin-7 (CYT107) Therapy on Specific Immune Responses to Vaccines (in Particular to Neo Antigens) in Older Subjects Following Chemotherapy||8 weeks|Insufficient data was collected for any analysis to take place. The study was closed due to lack of drug supply.|||||
841406|NCT01339013|Primary|Airway Dead Space With Devices for Heat and Moisture Exchange of Respiratory Gas.|A conventional heat and moisture exchanger used in a respiratory circuit during anasthesia was exchanged by an AnaConDa. The AnaConDa causes re-breathing of carbon dioxide which clinically is equivalent to an increased airway dead space. The total airway dead space effect of the AnaConDa, i.e. volume of the device plus rebreathing from the charcoal filter was measured using the Single Breath Test for carbon dioxide, as was airway deadspace of the conventional Heat and Moisture Exchanger. Airway dead space differences between devices was calculated by subtraction of volumes thus achieved. Difference= Airway dead space AnaConDa - Airway dead space conventional Heat and Moisture Exchanger.|1 hour|||mL||95% Confidence Interval|Median
841408|NCT01339052|Secondary|Progression-Free Survival (PFS) [Cohort 2]|PFS is defined as the time from first dose to the earliest documentation of disease progression or death. Participants alive without evidence of PD were censored at the date of last disease assessment. Progressive disease was established based on Response Assessment in Neuro-Oncology (RANO) criteria (Wen et al JCO 2010). See outcome measure #2.|Participants were assessed radiologically every other cycle on treatment and off-treatment via medical record review until death. Cohort 2 participants were followed for progression-free survival up to 12 months in this study cohort.|The analysis dataset is comprised of all treated participants.||months||95% Confidence Interval|Median
841409|NCT01339052|Secondary|Overall Survival (OS) [Cohort 2]|Overall survival is defined as the time from date of first dose to death or date last known alive and estimated using Kaplan-Meier (KM) methods.|Participants were followed long-term for survival via medical record review. Cohort 2 participants were followed for survival up to 52 months in this study cohort.|The analysis dataset is comprised of all treated participants.||months||95% Confidence Interval|Median
841410|NCT01339052|Secondary|Time to Maximum Observed Plasma Concentration (Tmax) of BKM120 Day 1 and Day 8 [Cohort 1]|Plasma concentrations of BKM120 were analyzed by a validated liquid chromatography-tandem mass spectrometry assay developed by Novartis Pharma AG. Standard Pk parameters were determined using non-compartmental methods.|On days 1 and 8 (+/- 1 day) prior to surgery, 5 blood samples were collected at the following timepoints: pre-dose, and at 0.5, 1.5, 3, and 5 hours post-dose.|The analysis dataset is comprised of all treated patients.||hours||Full Range|Median
841411|NCT01339052|Secondary|AUC0-5h Accumulation Ratio of BKM120 Day 1 and Day 8 [Cohort 1]|"Plasma concentrations of BKM120 were analyzed by a validated liquid chromatography-tandem mass spectrometry assay developed by Novartis Pharma AG. Standard Pk parameters were determined using non-compartmental methods.
The accumulation ratio is day 8/day 1."|On days 1 and 8 (+/- 1 day) prior to surgery, 5 blood samples were collected at the following timepoints: pre-dose, and at 0.5, 1.5, 3, and 5 hours post-dose.|The analysis dataset is comprised of all treated patients.||ratio day 8/day 1||Full Range|Mean
841412|NCT01339052|Secondary|Area Under the Concentration Curve From Time 0 to Last Concentration (AUC0-5h) of BKM120 Day 1 and Day 8 [Cohort 1]|"Plasma concentrations of BKM120 were analyzed by a validated liquid chromatography-tandem mass spectrometry assay developed by Novartis Pharma AG. Standard Pk parameters were determined using non-compartmental methods.
NOTE: This outcome measure was previously titled: Investigate Pharmacokinetics of BKM120 in This Population by Comparing the Drug Exposure Area Under the Curve (AUC0-5h) From Day 1 to Day 8”"|On days 1 and 8 (+/- 1 day) prior to surgery, 5 blood samples were collected at the following timepoints: pre-dose, and at 0.5, 1.5, 3, and 5 hours post-dose.|The analysis dataset is comprised of all treated patients.||ug*h/mL||Standard Deviation|Mean
841413|NCT01339052|Secondary|Cmax Accumulation Ratio of BKM120 Day 1 and Day 8 Ratio [Cohort 1]|Plasma concentrations of BKM120 were analyzed by a validated liquid chromatography-tandem mass spectrometry assay developed by Novartis Pharma AG. Standard Pk parameters were determined using non-compartmental methods. The accumulation ratio is day 8/day 1.|On days 1 and 8 (+/- 1 day) prior to surgery, 5 blood samples were collected at the following timepoints: pre-dose, and at 0.5, 1.5, 3, and 5 hours post-dose.|The analysis dataset is comprised of all treated patients.||ratio day 8/day 1||Full Range|Mean
841414|NCT01339052|Secondary|Maximum Observed Plasma Concentrations (Cmax) of BKM120 Day 1 and Day 8 [Cohort 1]|"Plasma concentrations of BKM120 were analyzed by a validated liquid chromatography-tandem mass spectrometry assay developed by Novartis Pharma AG. Standard Pk parameters were determined using non-compartmental methods.
NOTE: This outcome measure was previously titled: Investigate Pharmacokinetics of BKM120 in This Population by Comparing Maximum Plasma Concentrations (Cmax) From Day 1 to Day 8”"|On days 1 and 8 (+/- 1 day) prior to surgery, 5 blood samples were collected at the following timepoints: pre-dose, and at 0.5, 1.5, 3, and 5 hours post-dose.|The analysis dataset is comprised of all treated patients.||ng/mL||Standard Deviation|Mean
841415|NCT01339052|Secondary|Radiographic Response [Cohort 2]|Radiographic response was based on RANO (Response Assessment in Neuro-Oncology) criteria. Per RANO, complete response (CR): 1) Complete disappearance of all enhancing measurable and non-measurable disease sustained for at least 4 weeks, 2) No new lesions, 3) All lesions assessed using the same techniques as baseline, 4) No steroid use (or on physiologic replacement doses only), 5) Stable or improved non-enhancing (T2/FLAIR) lesions and 6) Stable or improved clinically; partial response (PR): 1) >/= 50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions (sum LD) sustained for at least 4 weeks and 2) No progression; progressive disease (PD): 1) > 25% increase sum LD and/or 2) significant increase in T2/FLAIR, 3) any new lesion, 4) clear clinical deterioration; stable disease (SD): none of the above.|Participants were assessed radiologically every other cycle on treatment. Cohort 2 participants were on treatment up to 9.2 months.|Only those participants who had measurable disease present at baseline and received at least one dose of therapy are considered evaluable for radiographic response||Participants|||Count of Participants
841416|NCT01339052|Secondary|% Ki-67 Reduction Using Immunohistochemistry (IHC) [Cohort 1]|Tumor cell proliferation and tumor cell death was using immunohistochemistry for Ki-67 based on established methods. Percent reduction was based on Ki-67 levels at baseline and at surgery.|Samples were collected at baseline (archival tumor specimen) and at surgery (surgical tumor specimen) which occurred after up to 12 days of BTK120 treatment.|The analysis dataset is comprised of all participants with a resected surgical tumor specimen (evaluable).||% reduction||Full Range|Median
841417|NCT01339052|Primary|BKM120 Plasma Concentration at Time of Surgery [Cohort 1]|Levels of BKM120 were determined by liquid chromatography coupled with tandem mass spectrometry.|Samples were collected at surgery which occurred after up to 12 days of BKM120 treatment.|The analysis dataset is comprised of all participants with a plasma sample at surgery (evaluable).||ng/mL||Standard Deviation|Mean
841418|NCT01339052|Primary|BKM120 Tumor Tissue Concentration at Time of Surgery [Cohort 1]|Levels of BKM120 were determined by liquid chromatography coupled with tandem mass spectrometry.|Samples were collected at surgery (resected surgical tumor specimen) which occurred after up to 12 days of BKM120 treatment.|The analysis dataset is comprised of all participants with a resected surgical tumor specimen (evaluable).||ng/gm||Full Range|Geometric Mean
841419|NCT01339052|Primary|BKM120 Brain-to-Plasma Ratio at Time of Surgery [Cohort 1]|Levels of BKM120 were determined by liquid chromatography coupled with tandem mass spectrometry. BKM120 tumor-to-plasma ratio at time of surgery was calculated based on these levels.|Samples were collected at surgery (surgical tumor specimen and plasma sample) which occurred after up to 12 days of BKM120 treatment.|The analysis dataset is comprised of participants with a paired plasma and brain tumor sample (evaluable). Participants missing a brain tumor sample (n=1) or plasma sample (n=2) are excluded from the calculation.||ratio tumor-to-plasma||Full Range|Geometric Mean
841420|NCT01339052|Primary|6-Month Progression-Free Survival (PFS6) [Cohort 2]|PFS6 is the proportion of participants remaining alive and progression-free at 6-months from cycle 1 day 1 of BKM120 treatment. Progressive disease is defined using RANO (Response Assessment in Neuro-Oncology) criteria (Wen et al JCO 2010), which takes modified Macdonald Criteria and adds assessment of non-enhancing lesions. Per RANO, progressive disease (PD) is defined either as > 25% increase in sum of the products of perpendicular diameters of enhancing lesions on stable or increasing doses of corticosteroids, or one or more of the of the following: 1) Significant increase in T2/FLAIR non-enhancing lesion on stable or increasing doses of corticosteroids steroids not due to co-morbid events; 2) Any new lesion; 3) Clear clinical deterioration not attributable to other causes apart from the tumor; or 4) Failure to return for evaluation due to death or deteriorating condition.|Participants were assessed radiologically every other cycle on treatment; Relevant for this outcome is up to month 6 evaluation.|The analysis dataset is comprised of all treated participants.||proportion of participants||90% Confidence Interval|Number
841421|NCT01339052|Primary|Change in pAKT (S473) Immunohistochemistry (IHC) Score From Baseline to Surgery [Cohort 1]|pAKT response was determined by pathologist-performed semi-quantitative IHC scoring for pAKT using previously established methods for glioblastoma (GBM) patients. Sample staining scored for intensity on a 0-2+ scale (0 none, 1+ weak positive, 2+ strong positive). Change in pAKT IHC score was the difference in score from baseline to surgery. Participants were classified into 3 groups: a reduction of staining score of one degree or more (considered a response), an increase in score and no change in score.|Samples were collected at baseline and at surgery (resected surgical tumor specimen) which occurred after up to 12 days of BKM120 treatment.|The analysis dataset is comprised of all treated participants.||Participants|||Count of Participants
841422|NCT01339091|Secondary|Clinical Status|Compare the clinical efficacy at the day 28 follow-up visit of dalbavancin to the comparator regimen based on lesion size, local signs, temperature and receipt of non-study antibiotics|Follow-Up Visit (day 28)|Clinical Evaluable Population based on certain inclusion/exclusion criteria, length of study therapy, concomitant antibacterials, concomitant surgical procedure and non-missing data.||participants|||Number
841423|NCT01339091|Secondary|Clinical Status|Compare the clinical efficacy at end of treatment visit of dalbavancin to the comparator regimen based on lesion size, local signs, temperature and receipt of non-study antibiotics|End of Treatment Visit (Day 14-15)|Clinical Evaluable Population based on certain inclusion/exclusion criteria, length of study therapy, concomitant antibacterials, concomitant surgical procedure and non-missing data.||participants|||Number
841424|NCT01339091|Secondary|>= 20% Reduction in Lesion Area|Clinical response at 48-72 hours post study drug initiation, based on measurements of acute bacterial skin and skin structure infections (ABSSSI) lesion size|48-72 hours after the initiation of study therapy|The ITT population consisted of all randomly assigned patients regardless of whether or not they received study drug.||participants|||Number
841425|NCT01339091|Primary|Early Clinical Efficacy|Clinical response at 48-72 hours post study drug initiation, based on measurements of acute bacterial skin and skin structure infections (ABSSSI) lesion size and temperature|48-72 hours after the initiation of study therapy|The ITT population consisted of all randomly assigned patients regardless of whether or not they received study drug.||participants|||Number
841426|NCT01344616|Secondary|Gestational Weight||9 months||||||
841427|NCT01344616|Primary|Birthweight|Birth weight < 2500 grams|9 months|One Set of twins in the lifestyle counseling arm and 4 sets of twins in the usual clinical care arm||participants|||Number
841428|NCT01344629|Secondary|MRTpo|mean residence time of Telmisartan in the body after oral administration|Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration|One subject who discontinued the study on period 2 was excluded from Pharmacokinetic data set. In analysis only used data which the parameter can be calculated.||hour||Geometric Coefficient of Variation|Geometric Mean
841429|NCT01344629|Secondary|t1/2|terminal half-life of Telmisartan in plasma|Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration|One subject who discontinued the study on period 2 was excluded from Pharmacokinetic data set. In analysis only used data which the parameter can be calculated.||hour||Geometric Coefficient of Variation|Geometric Mean
841430|NCT01344629|Secondary|λz|terminal rate constant of Telmisartan in plasma|Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration|One subject who discontinued the study on period 2 was excluded from Pharmacokinetic data set. In analysis only used data which the parameter can be calculated.||/hour||Geometric Coefficient of Variation|Geometric Mean
841431|NCT01344629|Secondary|Tmax|time from dosing to the maximum concentration of Telmisartan in plasma|Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration|One subject who discontinued the study on period 2 was excluded from Pharmacokinetic data set. Therefore, the number of observed PK parameter were 32+32+31+31=126 in T80/A5 FDC tablet and T80 + A5, respectively.||hour||Full Range|Mean
841432|NCT01344629|Secondary|AUC0-∞|area under the concentration-time curve of Telmisartan in plasma over the time interval from 0 extrapolated to infinity|Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration|One subject who discontinued the study on period 2 was excluded from Pharmacokinetic data set. In analysis only used data which the parameter can be calculated.||ng*hour/mL||Geometric Coefficient of Variation|Geometric Mean
841433|NCT01344629|Primary|Cmax|maximum measured concentration of Telmisartan in plasma|Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration|One subject who discontinued the study on period 2 was excluded from Pharmacokinetic data set. Therefore, the number of observed PK parameter were 32+32+31+31=126 in T80/A5 FDC tablet and T80 + A5, respectively.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
841434|NCT01344629|Primary|AUC0-tz|Area under the concentration-time curve of Telmisartan in plasma over the time interval from 0 to the time of the last quantifiable data point|Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration|One subject who discontinued the study on period 2 was excluded from Pharmacokinetic data set. Therefore, the number of observed PK parameter were 32+32+31+31=126 in T80/A5 FDC tablet and T80 + A5, respectively.||ng*hour/mL||Geometric Coefficient of Variation|Geometric Mean
841435|NCT01344759|Secondary|Room Air SpO2|The patient's oxygen saturation on room air.|During MRI and until recovery room discharge - approximately 30-250 minutes|||percentage of SpO2||Inter-Quartile Range|Mean
841436|NCT01344759|Secondary|Needed Artificial Airway|This is the count of the number of patients who needed an artificial airway.|During MRI and until recovery room discharge - approximately 30-250 minutes|||Number of artifical airway events|||Number
841437|NCT01344759|Secondary|Respiratory Disturbance Index|The respiratory disturbance index is a count of respiratory disturbance events per hour of sleep.|During MRI and until recovery room discharge - approximately 30-250 minutes|||respir.disturbance events/hr of sleep||Inter-Quartile Range|Mean
841438|NCT01344759|Secondary|Obstructive Index Until Recovery Room Discharge|The Obstructive Index is a count of the obstructive apnea events per hour of sleep|During MRI and until recovery room discharge - approximately 30-250 minutes|||Apnea events/hour of sleep||Inter-Quartile Range|Mean
841439|NCT01344759|Primary|Cross Sectional Area of the Pharyngeal Airway|The primary outcome measures will be the cross sectional area of the pharyngeal airway of the patients measured at two levels soft palate (nasopharyngeal) and base of the tongue (retroglossal). Magnetic resonance images of the airway were obtained during low (1 mcg/kg/hr) and high (3 mcg/kg/hr) doses of DEX or low (100 mcg/kg/m) and high (200 mcg/kg/m) doses of Propofol. All were administered through an intravenous (IV) catheter.|during MRI within first 10 minutes of scanning|||mm^2||95% Confidence Interval|Median
841443|NCT01344876|Primary|Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)|DLT was defined as adverse events occurring during Cycle 1 and: (1) Grade 3 or higher nausea, vomiting, or diarrhea despite the use of anti-emetic or antidiarrheal drugs, (2) Grade 3 or higher non-hematologic toxicity, excluding alopecia, (3) AEs requiring interruption of the IMP for a total of 8 days or longer, (4) Grade 4 neutropenia lasting ≥ 8 days (not applicable for leukemia), (5) Grade 3 or higher febrile neutropenia or infection due to neutropenia (not applicable for leukemia), (6) Grade 4 thrombocytopenia or Grade 3 thrombocytopenia requiring platelet transfusion (not applicable for leukemia).|From first study medication to on Day 31 (after repeated 28 days medication from Day 4 to 31)|DLT evaluated subjects who had achieved ≧75% study drug compliance during a 4-week (28-day) treatment period starting from Day 4. No statistical analysis provided for Subjects With DLTs.||participants|||Number
841444|NCT01344876|Secondary|Treatment Response|"Assessment of the treatment response was evaluated according to internationally recognized response criteria for multiple myeloma, non-Hodgkin’s lymphoma, acute myeloid leukemia, chronic myeloid leukemia.
“Response” was defined as at least partial response or partial remission (PR) according to the criteria for efficacy assessment."|From first dose of study medication to withdrawal examination|"Efficacy population included all treated subjects who had received at least 1 dose of study drug.
No statistical analysis provided for treatment response."||participants|||Number
841445|NCT01344876|Primary|Subjects With Treatment Emergent Adverse Events|Treatment emergent adverse events observed during outcome measure time frame. A Treatment Emergent Adverse Event was defined as an AE occurring after the start of IMP administration.|From first study medication to on Day 31 (after repeated 28 days medication from Day 4 to 31)|Safety population No statistical analysis provided for Subjects With Treatment Emergent Adverse Events.||participants|||Number
841446|NCT01345240|Secondary|Number of Subjects With Any and Fatal Serious Adverse Events (SAEs)|A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or a reported adverse event of specific interest such as seizures occurring within a 30-day period of vaccination, immune-mediated disorders, and specific autoimmune diseases. A fatal SAE was defined as a SAE resulting in the death of the study subject.|Up to Study End at Month 51||12/2017||||
841447|NCT01345240|Secondary|Number of Subjects With Any and Fatal Serious Adverse Events (SAEs)|A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or a reported adverse event of specific interest such as seizures occurring within a 30-day period of vaccination, immune-mediated disorders, and specific autoimmune diseases. A fatal SAE was defined as a SAE resulting in the death of the study subject.|From Day 0 to Month 26|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Participants|||Count of Participants
841613|NCT01346592|Secondary|The HI GMTs Against Heterologous Strains, by Vaccine Group (6 to <72 Months Age Group)|The HI antibody titers against the heterologous strains following vaccination with either aTIV, licensed comparator or TIV, at three weeks and at six months after vaccination are reported as GMTs.|Day 1, Day 50, Day 209|Analysis was done on the FAS Persistence||Titers||95% Confidence Interval|Geometric Mean
841448|NCT01345240|Secondary|Number of Subjects With Any and Fatal Serious Adverse Events (SAEs)|A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or a reported adverse event of specific interest such as seizures occurring within a 30-day period of vaccination, immune-mediated disorders, and specific autoimmune diseases. A fatal SAE was defined as a SAE resulting in the death of the study subject.|From Day 0 to Month 8|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Participants|||Count of Participants
841449|NCT01345240|Secondary|Number of Subjects With Any and Fatal Serious Adverse Events (SAEs)|A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or a reported adverse event of specific interest such as seizures occurring within a 30-day period of vaccination, immune-mediated disorders, and specific autoimmune diseases. A fatal SAE was defined as a SAE resulting in the death of the study subject.|Within the 30-day follow-up periods (Days 0-29) after vaccination with RTS,S vaccine or Engerix-B™|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Participants|||Count of Participants
841450|NCT01345240|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within the 30-day follow-up periods (Days 0-29) after vaccination with RTS,S vaccine or Engerix-B™|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Participants|||Count of Participants
841451|NCT01345240|Secondary|Number of Subjects With Potential Immune Mediated Disorders (pIMDs)|A potential immune mediated disorder (pIMD) was defined as an event about which concerns arose that vaccination may have interfered with immunological self-tolerance of the subjects. IMDs assessed included among others neuroinflammatory disorders (such as optic neuritis, multiple sclerosis, or encephalitis), musculoskeletal disorders (such as cutaneous lupus, rheumatoid arthritis, juvenile arthritis, or psoriatic arthropathy), gastrointestinal disorders (ulcerative colitis and ulcerative proctitis, celiac disease), metabolic diseases (such as autoimmune thyroiditis, or diabetes Mellitus Type 1, Addison’s disease), skin disorders (such as psoriasis or vitiligo), and other disorders such as vasculitis, pernicious anemia, or, sarcoidosis.|Up to Study End at Month 51||12/2017||||
841452|NCT01345240|Secondary|Number of Subjects With Potential Immune Mediated Disorders (pIMDs)|A potential immune mediated disorder (pIMD) was defined as an event about which concerns arose that vaccination may have interfered with immunological self-tolerance of the subjects. IMDs assessed included among others neuroinflammatory disorders (such as optic neuritis, multiple sclerosis, or encephalitis), musculoskeletal disorders (such as cutaneous lupus, rheumatoid arthritis, juvenile arthritis, or psoriatic arthropathy), gastrointestinal disorders (ulcerative colitis and ulcerative proctitis, celiac disease), metabolic diseases (such as autoimmune thyroiditis, or diabetes Mellitus Type 1, Addison’s disease), skin disorders (such as psoriasis or vitiligo), and other disorders such as vasculitis, pernicious anemia, or, sarcoidosis.|From Day 0 to Month 26|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Participants|||Count of Participants
841453|NCT01345240|Secondary|Number of Subjects With Potential Immune Mediated Disorders (pIMDs)|A potential immune mediated disorder (pIMD) was defined as an event about which concerns arose that vaccination may have interfered with immunological self-tolerance of the subjects. IMDs assessed included among others neuroinflammatory disorders (such as optic neuritis, multiple sclerosis, or encephalitis), musculoskeletal disorders (such as cutaneous lupus, rheumatoid arthritis, juvenile arthritis, or psoriatic arthropathy), gastrointestinal disorders (ulcerative colitis and ulcerative proctitis, celiac disease), metabolic diseases (such as autoimmune thyroiditis, or diabetes Mellitus Type 1, Addison’s disease), skin disorders (such as psoriasis or vitiligo), and other disorders such as vasculitis, pernicious anemia, or, sarcoidosis.|From Day 0 to Month 8.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Participants|||Count of Participants
841454|NCT01345240|Secondary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms were fever, irritability/fussiness, drowsiness, and loss of appetite. Fever was defined as axillary temperature higher than (>) 37.5 degrees Celsius (°C). Analysis for this outcome was performed solely for the 7-days follow-up periods following the primary vaccination with RTS,S vaccine or Engerix-B™ (at Day 0, and Months 1 and 2). Data presented are those for any occurrence of the assessed solicited general symptoms, that is, the occurrences of these symptoms regardless of their intensity grade or relationship to vaccination.|Within the 7-day follow-up period (Days 0-6) after administration of Dose (D) 1, 2 and 3, respectively, with RTS,S or Engerix-B™ vaccine|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Participants|||Count of Participants
841455|NCT01345240|Secondary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling at the site of injection. All solicited local symptoms assessed were considered by the investigator as causally related to the study vaccination. Analysis for this outcome was performed solely for the 7-days follow-up periods following the primary vaccination with RTS,S vaccine or Engerix-B™ (at Day 0, and Months 1 and 2). Data presented are those for any occurrence of the assessed solicited local symptoms, that is, the occurrences of these symptoms regardless of their intensity grade.|Within the 7-day follow-up period (Days 0-6) after administration of Dose (D) 1, 2 and 3, respectively, with RTS,S or Engerix-B™ vaccine|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Participants|||Count of Participants
841527|NCT01345682|Secondary|Overall Survival (OS)|Overall survival (OS) was a key secondary endpoint of this trial. OS was defined as the time from randomisation to death (irrespective of the cause of death). Patients for whom there was no evidence of death at the cut-off date (30 Jun 2014) were to be censored on the date that they were last known to be alive.|From randomization until death or data cut-off (30Jun2014); Up to 29 months|RS||months||95% Confidence Interval|Median
841456|NCT01345240|Secondary|Anti-Rotavirus (Anti-RV) Antibody Concentrations|Anti-Rotavirus (anti-RV) antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs). The cut-off of the assay was the seropositive cut-off value of greater than or equal to (>=) 20 units per milliliter (U/mL). This outcome measure was assessed in subjects who were administered Rotarix™ as part of an EPI regimen, with and without RTS,S vaccine co-administration. This outcome concerns the subjects who received the RTS,S or Engerix-B™ vaccine co-administered with Rotarix™. Results presented are for the study groups pooled by RTS,S or Engerix-B™ vaccine co-administration, that is, for the RTS,S Regimen B and Engerix-B Regimen B groups.|At Month 3, aka one month post Dose 2 of Rotarix™|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.||U/mL||95% Confidence Interval|Geometric Mean
841457|NCT01345240|Secondary|Concentrations of Antibodies Against Acellular B-pertussis (BPT)|The antibodies against BPT assessed were against pertussis toxoid (anti-PT), against filamentous haemagglutinin (anti-FHA), and against pertactin (anti-PRN). Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs), in ELISA units per milliliter (EL.U/mL). The cut-off of the assay was the seropositivity cut-off value of greater than or equal to (>=) 5 EL.U/mL.|At Day 0 and at Month 3 (one month post Dose 3 of Infanrix™-Hib)|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
841458|NCT01345240|Secondary|Anti-protein D (PD) Antibody Concentrations|Anti-PD antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs), in ELISA units per milliliter (EL.U/mL). The cut-off of the assay was the seropositivity cut-off value of greater than or equal to 100 EL.U/mL. .|At Month 17, aka one month post the Month 16 booster dose of Synflorix™|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
841459|NCT01345240|Secondary|Anti-protein D (PD) Antibody Concentrations|Anti-PD antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs), in ELISA units per milliliter (EL.U/mL). The cut-off of the assay was the seropositivity cut-off value of greater than or equal to 100 EL.U/mL. This outcome concerns the subjects who received the RTS,S or Engerix-B™ vaccine co-administered with Synflorix™. Results presented are for the study groups pooled by co-administration, that is, for the RTS,S Regimen A and Engerix-B Regimen A groups.|At Month 3, aka at one month post Dose 3 of Synflorix™|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
841460|NCT01345240|Secondary|Titers for Opsonophagocytic Activity Against Synflorix™ Pneumococcal Vaccine Serotypes.|The pneumococcal vaccine serotypes assessed were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Streptococcus pneumoniae opsonophagocytic activity was presented as the dilution of serum (opsonic titer) able to sustain 50 % killing of live pneumococci under the assay conditions, expressed as geometric mean titers (GMTs). The cut-off of the assay was an opsonic dilution >= 8.|At Month 17, aka one month post the Month 16 booster dose of Synflorix™|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.||Titer||95% Confidence Interval|Geometric Mean
841461|NCT01345240|Secondary|Titers for Opsonophagocytic Activity Against Synflorix™ Pneumococcal Vaccine Serotypes.|"The pneumococcal vaccine serotypes assessed were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Streptococcus pneumoniae opsonophagocytic activity was presented as the dilution of serum (opsonic titer) able to sustain 50 % killing of live pneumococci under the assay conditions, expressed as geometric mean titers (GMTs). The cut-off of the assay was an opsonic dilution >= 8.
This outcome concerns the subjects who received the RTS,S or Engerix-B™ vaccine co-administered with Synflorix™. Results presented are for the study groups pooled by co-administration, that is, for the RTS,S Regimen A and Engerix-B Regimen A groups."|At Month 3, aka at one month (1M) post Dose 3 of Synflorix™|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.||Titer||95% Confidence Interval|Geometric Mean
841462|NCT01345240|Secondary|Pneumococcal Antibody Concentrations Against Synflorix™ Pneumococcal Vaccine Serotypes.|Antibody concentrations were measured by GSK assay, and expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The pneumococcal vaccine serotypes assessed were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The cut-off of the assay, by GSK assay, was greater than or equal to (>=) 0.2 μg/mL. This corresponds to a cut-off value of 0.35μg/mL by enzyme-linked immunosorbent assay (ELISA).|At Month 17, aka one month post the Month 16 booster dose of Synflorix™|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.||μg/mL||95% Confidence Interval|Geometric Mean
841640|NCT01347008|Primary|Digital Skin Microvascular Blood Flow Measured by Laser Doppler Imaging (LDI) Before Cold Stimulus|Finger blood flow of the four medial fingers, measured by laser Doppler imaging and expressed in arbitrary perfusion units (p.u.).|8 weeks|||perfusion units||Standard Deviation|Mean
841463|NCT01345240|Secondary|Pneumococcal Antibody Concentrations Against Synflorix™ Pneumococcal Vaccine Serotypes.|Antibody concentrations were measured by enzyme-linked immunosorbent assa y (ELISA), and expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The pneumococcal vaccine serotypes assessed were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The cut-off of the assay, by GSK assay, was greater than or equal to (>=) 0.2 µg/mL. This corresponds to a cut-off value of 0.35μg/mL. This outcome concerns the subjects who received the RTS,S or Engerix-B™ vaccine co-administered with Synflorix™. Results presented are for the study groups pooled by co-administration, that is, for the RTS,S Regimen A and Engerix-B Regimen A groups.|At Month 3, aka at one month post Dose 3 of Synflorix™|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.||µg/mL||95% Confidence Interval|Geometric Mean
841464|NCT01345240|Secondary|Anti-circumsporozoite Protein (Anti-CS) Antibody Concentrations .|Anti-CS antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean concentrations (GMCs) expressed in ELISA units per milliliter (EL.U/mL). The assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 0.5 EL.U/mL.|At Month 14, aka at 12 months post Dose 3 of RTS,S vaccine or Engerix-B™.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
841465|NCT01345240|Secondary|Anti-circumsporozoite Protein (Anti-CS) Antibody Concentrations|Anti-CS antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean concentrations (GMCs) expressed in ELISA units per milliliter (EL.U/mL). The assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 0.5 EL.U/mL. The table shows results with study groups pooled by vaccination regimen received.|At Month 3, aka at one month post Dose 3 of RTS,S vaccine or Engerix-B™|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
841466|NCT01345240|Secondary|Concentrations of Antibodies to the Hepatitis B RF1 Surface Antigen (Anti-HBs RF1).|Anti-HBs RF1 antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean concentrations (GMCs) expressed in ELISA units per milliliter (EL.U/mL). The assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 33 EL.U/mL. Results will be posted when they become available.|At Month 51, aka one month post the Month 50 booster dose of Engerix-B™||12/2017||||
841467|NCT01345240|Secondary|Concentrations of Antibodies to the Hepatitis B RF1 Surface Antigen (Anti-HBs RF1).|Anti-HBs RF1 antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean concentrations (GMCs) expressed in ELISA units per milliliter (EL.U/mL). The assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 33 EL.U/mL.|At Month 3, aka at one month post Dose 3 of RTS,S vaccine or Engerix-B™|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
841468|NCT01345240|Secondary|Anti-Hepatitis B (HBs) Antibody Concentrations.|Concentrations, by enzyme-linked immunosorbent assay (ELISA), were presented as geometric mean concentrations (GMCs), and expressed in milli-international units per milliliter (mIU/mL). The assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 10 mIU/mL. Results will be posted when they become available.|At Months 38, 50 and 51, aka 36 and 48 months post Dose 3 of RTS,S vaccine or Engerix-B™ and one month post the Month 50 booster dose of Engerix-B™||12/2017||||
841469|NCT01345240|Secondary|Anti-Hepatitis B (HBs) Antibody Concentrations.|Concentrations, by enzyme-linked immunosorbent assay (ELISA), were presented as geometric mean concentrations (GMCs), and expressed in milli-international units per milliliter (mIU/mL). The assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 10 mIU/mL.|At Months 14 and 26, aka at 12 and 24 months post Dose 3 of RTS,S vaccine or Engerix-B™|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.||mIU/mL||95% Confidence Interval|Geometric Mean
841470|NCT01345240|Secondary|Anti-Hepatitis B (HBs) Antibody Concentrations|Concentrations, by enzyme-linked immunosorbent assay (ELISA), were presented as geometric mean concentrations (GMCs), and expressed in milli-international units per milliliter (mIU/mL). The assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 10 mIU/mL. A decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis. Results presented are for the study groups receiving the RTS,S vaccine, pooled by vaccine lot, that is, for the RTS,S Lot 1, RTS,S Lot 2, and RTS,S Lot 3 groups, as defined below.|At Month 3, aka at one month post Dose 3 of RTS,S vaccine or Engerix-B™|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.||mIU/mL||95% Confidence Interval|Geometric Mean
841486|NCT01345318|Primary|Percentage of Participants Developing Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs)|Samples were analyzed using the semi-quantitative electrochemiluminescent (ECL) immunoassay method, a validated analytical method in compliance with sponsor's standard operating procedures. ADA positive is defined as ADA titer greater than or equal to (>=) 4.32. Any positive ADA sample was further tested for NAbs.|At Baseline and Weeks 8, 16, 24, 32, 40, 48, 56, 64, 72 and 76.|The safety analysis set was defined as all participants who received at least one dose of PF-04236921during the study.||percentage of participants|||Number
841471|NCT01345240|Primary|Anti-Hepatitis B (HBs) Antibody Concentrations.|Concentrations, by enzyme-linked immunosorbent assay (ELISA), were presented as geometric mean concentrations (GMCs), and expressed in milli-international units per milliliter (mIU/mL). The assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 10 mIU/mL. A decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis, with study groups pooled by RTS,S or Engerix-B™ vaccination regimen received.|At Month 3, aka at one month post Dose 3 of RTS,S vaccine or Engerix-B™|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.||mIU/mL||95% Confidence Interval|Geometric Mean
841472|NCT01345240|Primary|Anti-Hepatitis B (HBs) Antibody Concentrations|Concentrations, by enzyme-linked immunosorbent assay (ELISA), were presented as geometric mean concentrations (GMCs), and expressed in milli-international units per milliliter (mIU/mL). The assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 10 mIU/mL. A decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis, with study groups pooled by primary vaccine administered (RTS,S vs Engerix-B™).|At Month 3, aka at one month post Dose 3 of RTS,S vaccine or Engerix-B™|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.||mIU/mL||95% Confidence Interval|Geometric Mean
841478|NCT01345292|Secondary|Global Subjective VAS Score at Week 4|"At each visit, participants rated their perception of the pain/discomfort experienced by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. Participants were instructed as follows: Please rate the intensity of the pain/discomfort you have experienced in the last two weeks when drinking cold/hot beverages and/or foods, eating sweet and sour foods, breathing cold air, brushing your teeth or performing any habits/behaviors that solicit your dentinal hypersensitivity pain/discomfort since you first started using the product. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm."|4 weeks|Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||units on a scale (mm)||Standard Error|Least Squares Mean
841479|NCT01345292|Secondary|Global Subjective VAS Score at Week 2|"At each visit, participants rated their perception of the pain/discomfort experienced by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. Participants were instructed as follows: Please rate the intensity of the pain/discomfort you have experienced in the last two weeks when drinking cold/hot beverages and/or foods, eating sweet and sour foods, breathing cold air, brushing your teeth or performing any habits/behaviors that solicit your dentinal hypersensitivity pain/discomfort since you first started using the product. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm."|2 weeks|Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||units on a scale (mm)||Standard Error|Least Squares Mean
841480|NCT01345292|Secondary|Mean Cold Air Stimulus VAS Score at Week 4|Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|4 weeks|Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||units on a scale (mm)||Standard Error|Least Squares Mean
841481|NCT01345292|Secondary|Mean Cold Air Stimulus VAS Score at Week 2|Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|2 weeks|Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||units on a scale (mm)||Standard Error|Least Squares Mean
841482|NCT01345292|Secondary|Mean Tactile Sensitivity VAS Score at Week 4|Tooth sensitivity was measured using a VAS. At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|4 weeks|Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||units on a scale (mm)||Standard Error|Least Squares Mean
841483|NCT01345292|Secondary|Mean Tactile Sensitivity Visual Analog Scale (VAS) Score at Week 2|Tooth sensitivity was measured using a VAS. At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|2 weeks|Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||units on a scale (mm)||Standard Error|Least Squares Mean
841484|NCT01345292|Primary|Mean Tactile Sensitivity Score at Week 2|Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|2 weeks|Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||grams of force||Standard Error|Least Squares Mean
841485|NCT01345292|Primary|Mean Tactile Sensitivity Score at Week 4|Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|4 weeks|Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||grams of force||Standard Error|Least Squares Mean
841539|NCT01345786|Secondary|Volume of Distribution (Calculated for NOMAC Only)||blood samples were collected for NOMAC evaluation up to 144 hours postdose|"The # of plasma profiles analyzed is based on the # of single-dose administration periods actually completed (some participants discontinued without completing all 4 dosing periods).
Part 1 analyses also excluded certain data from participants who were misdosed, and Part 2 analyses excluded participants who did not receive drug."||L|Participants|Standard Deviation|Mean
841487|NCT01345318|Primary|Number of Participants With On-Treatment Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs|An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of death); persistent or significant disability/incapacity; congenital anomaly. Lack of efficacy was reported as an AE when it was associated with a SAE. An AE was considered treatment emergent if it started for the first time in a participant on or after the first day of active treatment, or the event started before the first day of active treatment but increased in severity during active treatment. AEs included both SAEs and non-serious AEs.|Baseline up to Week 48|The safety analysis set was defined as all participants who received at least one dose of PF-04236921during the study.||participants|||Number
841488|NCT01345591|Secondary|SWAP, COPE and CSQ-8|three questionnaires were evaluated: 1) SWAP (satisfaction with appearance scale) is a psychological test for personality diagnosis and clinical case formulation; 14 questions are asked on a scale of 0-7 where 7 indicates descriptive of the subjects and 0 is irrelevant to the subject for a total score range of 0-98. 2) COPE scale assesses a broad range of coping responses over 28 questions scaled from 1-4 with a total score range of 28-112 where the higher score indicates higher frequency of coping mechanisms used by the subject. 3) CSQ-8 assesses patient satisfaction with the treatment through 8 questions ranked 1-4 on a total scale from 8-32 where higher scores indicate greater satisfaction.|as assessed at baseline, 7-21 days, 3 months and 9 months post op.|||units on a scale||Standard Deviation|Mean
841489|NCT01345591|Primary|Volume|fat graft volume|3 months and 9 months post op.|||milliliters||Standard Deviation|Mean
841490|NCT01345630|Secondary|Change in Bone Turnover Markers From Baseline and at Week 48 - Type 1 Collagen Peptide (CTX-1)|Bone turnover marker, C-telopeptide of type 1 collagen (CTx), was collected in the subset of participants participating in the DEXA scan sub-study.|Week 48|Safety Analysis Set was the same as the FAS consisting of all randomized participants who received at least one dose of the study drug but analyzed as realized for tropism assay and treatment. Missing values were imputed using LOCF approach.||pg/mL||Standard Deviation|Mean
841491|NCT01345630|Secondary|Change in Bone Turnover Markers From Baseline and at Week 48 - Blood Osteocalcin|Bone turnover marker, osteocalcin, was collected in the subset of participants participating in the DEXA scan sub-study.|Week 48|Safety Analysis Set was the same as the FAS consisting of all randomized participants who received at least one dose of the study drug but analyzed as realized for tropism assay and treatment. Missing values were imputed using LOCF approach.||ng/mL||Standard Deviation|Mean
841492|NCT01345630|Secondary|Changes in Bone Mineral Density (Using DEXA Scan and Serum Markers) From Baseline and at Week 48 - AP Lumbar Spine (L1 - L4) BMD|Bone mineral density was evaluated by DEXA scan in a subset of participants who consented to these evaluations. The effects on BMD were addressed by providing LSMs of change from baseline bone mineral density of the lumbar spine (L1-L4) as measured by the DEXA scan.|Week 48|Safety Analysis Set was the same as the FAS consisting of all randomized participants who received at least one dose of the study drug but analyzed as realized for tropism assay and treatment. Missing values were imputed using LOCF approach.||g/cm^2||Standard Error|Least Squares Mean
841493|NCT01345630|Secondary|Changes in Bone Mineral Density (Using DEXA Scan and Serum Markers) From Baseline and at Week 48 - Femoral Neck BMD|Bone mineral density was evaluated by DEXA scan in a subset of participants who consented to these evaluations. The effects on BMD were addressed by providing LSMs of change from Baseline bone mineral density femoral neck as measured by the DEXA scan.|Week 48|Safety Analysis Set was the same as the FAS consisting of all randomized participants who received at least one dose of the study drug but analyzed as realized for tropism assay and treatment. Missing values were imputed using LOCF approach.||g/cm^2||Standard Error|Least Squares Mean
841494|NCT01345630|Secondary|Changes in Bone Mineral Density (Using DEXA Scan and Serum Markers) From Baseline and at Week 48 - Total Hip BMD|Bone mineral density was evaluated by DEXA scan in a subset of participants who consented to these evaluations. The effects on BMD were addressed by providing LSMs of change from baseline bone mineral density of the lumbar spine (L1-L4), left total hip and femoral neck as measured by the DEXA scan.|Week 48|Safety Analysis Set was the same as the FAS consisting of all randomized participants who received at least one dose of the study drug but analyzed as realized for tropism assay and treatment. Missing values were imputed using LOCF approach.||g/cm^2||Standard Error|Least Squares Mean
841495|NCT01345630|Secondary|Changes in Trunk to Limb Fat Distribution Using DEXA Scan From Baseline and at Week 48|A sub-study was conducted in which the participants underwent whole-body DEXA scans to evaluate peripheral fat tissue estimates for left and right arms and legs and truncal fat mass and truncal lean mass. Truncal abdominal fat were estimated from the DEXA scan field set on the torso. The effects on estimates of fat mass and lean mass were addressed by providing LSMs of change from baseline.|Week 48|Safety Analysis Set was the same as the FAS consisting of all randomized participants who received at least one dose of the study drug but analyzed as realized for tropism assay and treatment. Missing values were imputed using LOCF approach.||ratio||Standard Error|Least Squares Mean
841496|NCT01345630|Secondary|Changes in Peripheral Fat Distribution Using Dual Energy X-ray Absorptiometry [DEXA] Scan From Baseline and at Week 48.|A sub-study was conducted in which the participants underwent whole-body DEXA scans to evaluate peripheral fat tissue estimates for left and right arms and legs and truncal fat mass and truncal lean mass. Truncal abdominal fat were estimated from the DEXA scan field set on the torso. The effects on estimates of fat mass and lean mass were addressed by providing LSMs of change from baseline.|Week 48|Safety Analysis Set was the same as the FAS consisting of all randomized participants who received at least one dose of the study drug but analyzed as realized for tropism assay and treatment. Missing values were imputed using LOCF approach.||gram||Standard Error|Least Squares Mean
841497|NCT01345630|Secondary|Absolute Change in CD4+/CD8+ Ratio From Baseline to Week 48|The differences in the magnitude of changes in CD4+/CD8+ ratio from Baseline through Weeks 48 for maraviroc versus emtricitabine/tenofovir were compared.|Baseline, Week 48|The FAS consisted of all randomized participants who received at least one dose of the study drug. Missing values were imputed using LOCF approach. Baseline was calculated as the average of all the pre-dose measurements excluding the screening value. If all pre-dose values were missing, screening value was considered as the baseline.||Ratio||Standard Deviation|Mean
841552|NCT01346059|Secondary|Mortality|Death within 30 days of enrollment, in or out of hospital|30 day|||Participants|||Count of Participants
841498|NCT01345630|Secondary|Percent Change From Baseline in Immune Cell Function at Week 48: Lymphocyte Activation Marker CD8 (%)|The differences in the magnitude of changes in CD8+ cell counts from Baseline through Week 48 for maraviroc versus emtricitabine/tenofovir were compared.|Baseline, Week 48|The FAS consisted of all randomized participants who received at least one dose of the study drug. Missing values were imputed using LOCF approach. Baseline was calculated as the average of all the pre-dose measurements excluding the screening value. If all pre-dose values were missing, screening value was considered as the baseline.||Percentage of lymphocytes||Standard Deviation|Mean
841499|NCT01345630|Secondary|Absolute Change From Baseline in Immune Cell Function at Week 48: Lymphocyte Marker Cluster of Differentiation 8 (CD8, Cell/mm^3)|The differences in the magnitude of changes in CD8+ cell counts from baseline through Week 48 for maraviroc versus emtricitabine/tenofovir were compared.|Baseline, Week 48|The FAS consisted of all randomized participants who received at least one dose of the study drug. Missing values were imputed using LOCF approach. Baseline was calculated as the average of all the pre-dose measurements excluding the screening value. If all pre-dose values were missing, screening value was considered as the baseline.||cell/mm^3||Standard Deviation|Mean
841500|NCT01345630|Secondary|Percent Change From Baseline in Immune Cell Function at Week 48: Lymphocyte Activation Marker CD4 (%)|The differences in the magnitude of changes in CD4+ from Baseline through Week 48 for maraviroc versus emtricitabine/tenofovir were compared.|Baseline, Week 48|The FAS consisted of all randomized participants who received at least one dose of the study drug. Missing values were imputed using LOCF approach. Baseline was calculated as the average of all the pre-dose measurements excluding the screening value. If all pre-dose values were missing, screening value was considered as the baseline.||Percentage of lymphocytes||Standard Deviation|Mean
841501|NCT01345630|Secondary|Absolute Change From Baseline in Immune Cell Function at Week 48: Lymphocyte Marker Cluster of Differentiation 4 (CD4, Cell/mm^3)|The differences in the magnitude of changes in CD4+ at Baseline and at Week 48 for maraviroc versus emtricitabine/tenofovir were compared.|Baseline, Week 48|The FAS consisted of all randomized participants who received at least one dose of the study drug. Missing values were imputed using LOCF approach. Baseline was calculated as the average of all the pre-dose measurements excluding the screening value. If all pre-dose values were missing, screening value was considered as the baseline.||cell/mm^3||Standard Deviation|Mean
841502|NCT01345630|Secondary|Number of Participants With Resistance to Nucleoside/Nucleotide Reverse Transcriptase Inhibitors (NRTI), Non-nucleoside Reverse Transcriptase Inhibitors (NNRTI), and Protease Inhibitors (PI) in Participants Meeting PDTF Criteria|For participants meeting the PDTF criteria, viral resistance (both genotypic and phenotypic) to NRTI, NNRTI, and PI’s were assessed at Baseline and on-treatment. The assessment was performed using the overall (i.e. net) susceptibility score provided using the PhenoSense GT assay. The number of participants with successful assessments were 15/17 for the MVC+DRV/r arm and 3/3 for the FTC/TDF+DRV/r arm.|Week 48|The FAS consisted of all randomized participants who received at least one dose of the study drug. The assessment was performed using the overall (ie. net) susceptibility score provided using the PhenoSense GT assay. The number of participants with successful assessments were 15 for the MVC+DRV/r arm and 3 for the FTC/TDF+DRV/r arm.||participants|||Number
841503|NCT01345630|Secondary|Number of Participants With Viral Resistance to Maraviroc (Maraviroc Treated Participants Only) in Participants Meeting PDTF Criteria.|For participants meeting the PDTF criteria, viral resistance to maraviroc for maraviroc treated participants was assessed in patients with R5 virus at failure. The resistance level is calculated by reference to a laboratory strain of virus that is analyzed in parallel with the clinical isolate to identify 50% inhibitory concentrations (IC50). The maximal percent inhibition is the percent inhibition that is achieved in a titration of the drug at high concentrations when the addition of more drug does not result in increased inhibition. Maximal percent inhibition is obtained in the same way as the titration for IC50, but the key measure is of the plateau height of percent inhibition, where increased concentration of maraviroc does not result in additional inhibition. This is consistent with the virus developing some ability to use maraviroc-bound CCR5 for entry. A significant change in IC50 is not required for this mechanism.|Week 48|The FAS consisted of all randomized participants who received at least one dose of the study drug.||participants|||Number
841504|NCT01345630|Secondary|Tropism Change Between Screening or Baseline and PDTF|For participants meeting the PDTF criteria, tropism was assessed using the original randomized and alternate assays (ie, both genotype testing and ESTA). Data reported here corresponds to the timepoint at or after PDTF.|Week 48|Number of Evaluable PDTF = Virology Analysis Population (VAP) 'Evaluability' is determined by the on-treatment viral load (≥400 copies/mL at sample time point).||participants|||Number
841505|NCT01345630|Secondary|Virologic Outcomes at Week 48 Using Protocol-Defined Treatment Failure (PDTF).|Per the protocol participants who meet the following criteria were regarded as PDTFs requiring a confirmatory plasma HIV-1 RNA determination: • Decrease in plasma HIV-1 RNA <1 log10 from baseline after Week 4 unless plasma HIV-1 RNA is <50 copies/mL, or • Plasma HIV-1 RNA >1.0 log10 above the nadir value after Week 4 where the nadir is the lowest plasma HIV-1 RNA concentration, or • Plasma HIV-1 RNA ≥50 copies/mL at any time after Week 24, or • Plasma HIV-1 RNA ≥50 copies/mL after suppression to <50 copies/mL on two consecutive visits, or • Decrease in plasma HIV-1 RNA ≤2 log10 from baseline on or after Week 12 unless plasma HIV-1 RNA is <400 copies/mL. Decrease in plasma HIV-1 RNA ≤2 log10 from baseline on or after Week 12 unless plasma HIV-1 RNA is <50 copies/mL (before August 30 2012) or <400 copies/mL (after August 30 2012).|Week 48|The FAS consisted of all randomized participants who received at least one dose of the study drug. No imputation for missing values was performed for this endpoint. 'Evaluability' is determined by the on-treatment viral load (≥400 copies/mL at sample time point).||Number of participants|||Number
841519|NCT01345682|Secondary|Status Change in Swallowing Scale|Distribution of patients with improved, stable or worsened HRQOL: Improvement was defined as a score improved by at least 10 points from baseline (on the 0-100 point scale) at any time during the trial. If a patient had not improved, worsening was defined as a 10-point worsening at any time during the trial. Otherwise, a patient was considered as stable.|From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.|RS (Only patients with observed cases (OC) values were analysed)||percentage of participants|||Number
841553|NCT01346059|Primary|Resolution of Diarrhea and White Blood Cell Count Elevation|If the patient has resolution of diarrhea, white blood cell count, and abdominal pain, the protocol will be stopped.|14 days|||Participants|||Count of Participants
841506|NCT01345630|Secondary|The Relationship Between the Proportion of Participants With Plasma HIV-1 RNA <50 Copies/mL at the Week 48 and the Screening Tropism Test (Genotype Test or ESTA).|The relationship of the proportion of participants achieving HIV-1 RNA <50 copies/mL at Week 48 with the screening tropism test for the MVC containing regimen was analyzed. Virologic response for a participant at Week 48 was derived using the FDA’s Snapshot MSDF algorithm. Difference in proportions of patients with plasma HIV-1 RNA <50 copies/mL at week 48 between the maraviroc and the emtricitabine/tenofovir treatment arms, with two-sided 95% confidence interval, among patients who are R5 by genotype (including some who were originally randomized to ESTA and are R5 by genotype upon retesting), were calculated via the Maximum Likelihood method. The estimate was adjusted for the screening plasma HIV RNA level (<100,000 vs. ≥100,000) copies/mL via the Mantel Haenszel (MH) method.|Week 48|The FAS consisted of all randomized participants who received at least one dose of the study drug.||proportion of participants|||Number
841507|NCT01345630|Secondary|Severity of Abnormal Laboratory Values|Number of participants who had clinically significant laboratory abnormalities of Grade 3 and Grade 4 according to DAIDS. Abnormality incidence of highest grade was reported for a labcode for each individual participant.|Week 96|Safety Analysis Set was the same as the FAS consisting of all randomized participants who received at least one dose of the study drug but analyzed as realized for tropism assay and treatment.||participants|||Number
841508|NCT01345630|Secondary|Number of Participants With Abnormal Laboratory Values|Number of participants with laboratory abnormalities are reported|Week 96|Safety Analysis Set was the same as the FAS consisting of all randomized participants who received at least one dose of the study drug but analyzed as realized for tropism assay and treatment. One participant was not analyzed for laboratory data as the collection date for all lab data was less than the first active therapy date.||participants|||Number
841509|NCT01345630|Secondary|Number of Participants With Treatment-emergent Serious Adverse Events|Total number of participants with treatment-emergent serious adverse events are reported|Week 96|Safety Analysis Set was the same as the FAS consisting of all randomized participants who received at least one dose of the study drug but analyzed as realized for tropism assay and treatment.||participants|||Number
841510|NCT01345630|Secondary|Number of Treatment-related AEs|Number of treatment-related AEs are presented here.|Week 96|Safety Analysis Set was the same as the FAS consisting of all randomized participants who received at least one dose of the study drug but analyzed as realized for tropism assay and treatment.||events|||Number
841511|NCT01345630|Secondary|Number of Participants Who Discontinued Due to AEs|Number of participants who discontinued due to AEs are reported here. Three participants (two from the MVC+DRV/r arm and one from the FTC/TDF+DRV/r arm) were not considered as discontinued due to AE because other reasons for discontinuation were prioritized for these participants.|Week 96|Safety Analysis Set was the same as the FAS consisting of all randomized participants who received at least one dose of the study drug but analyzed as realized for tropism assay and treatment.||participants|||Number
841512|NCT01345630|Secondary|Number of Participants With Grade 3 or 4 AEs|Number of participants with grade 3 or 4 AEs are presented here.|Week 96|Safety Analysis Set was the same as the FAS consisting of all randomized participants who received at least one dose of the study drug but analyzed as realized for tropism assay and treatment.||participants|||Number
841513|NCT01345630|Secondary|Frequency of Adverse Events (AE).|Number of participants with treatment-emergent non serious AEs|Week 96|Safety Analysis Set was the same as the FAS consisting of all randomized participants who received at least one dose of the study drug but analyzed as realized for tropism assay and treatment.||participants|||Number
841514|NCT01345630|Primary|Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL.|The proportion of participants who achieved HIV-1 RNA <50 copies/mL at week 48 was assessed according to Food and Drug Administration’s (FDA’s) Missing, Switch, Discontinuation’=Failure (MSDF) Snapshot algorithm. The algorithm used the plasma HIV-1 RNA in the Week 48 visit window, followed the “virology-first principle” and considers a participant who has a missing plasma HIV-1 RNA, or switches to prohibited ARV regimen or discontinues from the study or study drug for any reason, or dies, as a failure.|Week 48|The Full Analysis Set (FAS) consisted of all randomized participants who received at least one dose of the study drug. The missing value was imputed per FDA’s MSDF Snapshot algorithm as described under “Outcome Measure Description” above.||Percentage of participants|||Number
841515|NCT01345682|Secondary|Time to Deterioration in Global Health Status|The time to deterioration was defined as the time from randomisation to a score decreased (i.e. worsened) by at least 10 points from baseline (0-100 point scale). If score is missing, and patient died within 28 days after scheduled time for completion, the patient was considered deteriorated. In this case, time to deterioration is time to death.|From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.|RS||months||95% Confidence Interval|Median
841516|NCT01345682|Secondary|Time to Deterioration in Swallowing|The time to deterioration was defined as the time from randomisation to a score increased (i.e. worsened) by at least 10 points from baseline (0-100 point scale). If score is missing, and patient died within 28 days after scheduled time for completion, the patient was considered deteriorated. In this case, time to deterioration is time to death.|From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.|RS||months||95% Confidence Interval|Median
841517|NCT01345682|Secondary|Time to Deterioration in Pain|The time to deterioration was defined as the time from randomisation to a score increased (i.e. worsened) by at least 10 points from baseline (0-100 point scale). If score is missing, and patient died within 28 days after scheduled time for completion, the patient was considered deteriorated. In this case, time to deterioration is time to death.|From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.|RS||months||95% Confidence Interval|Median
841518|NCT01345682|Secondary|Status Change in Global Health Status Scale|Distribution of patients with improved, stable or worsened HRQOL: Improvement was defined as a score improved by at least 10 points from baseline (on the 0-100 point scale) at any time during the trial. If a patient had not improved, worsening was defined as a 10-point worsening at any time during the trial. Otherwise, a patient was considered as stable.|From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.|RS (Only patients with observed cases (OC) values were analysed)||percentage of participants|||Number
841520|NCT01345682|Secondary|Status Change in Pain Scale|Distribution of patients with improved, stable or worsened HRQOL: Improvement was defined as a score improved by at least 10 points from baseline (on the 0-100 point scale) at any time during the trial. If a patient had not improved, worsening was defined as a 10-point worsening at any time during the trial. Otherwise, a patient was considered as stable.|From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.|RS (Only patients with observed cases (OC) values were analysed)||percentage of participants|||Number
841521|NCT01345682|Secondary|Health Related Quality of Life (HRQOL)- Change in Global Health Scores Over Time|"The HRQOL analyses focused on pain, swallowing, and global health status measured by the European Organisation for Research and Treatment of Cancer [EORTC] quality of life questionnaires Core 30 [QLQ-C30], and head and neck cancer specific supplementary module EORTC QLQ-H&N35:
Pain scale from H&N35, Swallowing scale from H&N35 and Global health status/QoL scale from C30.
Pain scale includes items 31-34 from H&N 35; Swallowing scale includes items 35-38 from H&N35 and Global health status/QoL scale includes items 29-30 from C30.
The scores of these scales were averaged from the scores of the component items, transformed and analyzed on 0 - 100 scale. For pain and swallowing scales, higher scores represent worse outcome; for the global health/QoL scale, higher scores represent better outcome.
Changes in scores over time were assessed using longitudinal models.
The analyses of HRQOL are presented for the 07 May 2014 cut-off date."|From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.|RS (Only patients with observed cases (OC) values were analysed)||scores on a scale||Standard Error|Mean
841522|NCT01345682|Secondary|Health Related Quality of Life (HRQOL)- Change in Swallowing Scores Over Time|"The HRQOL analyses focused on pain, swallowing, and global health status measured by the European Organisation for Research and Treatment of Cancer [EORTC] quality of life questionnaires Core 30 [QLQ-C30], and head and neck cancer specific supplementary module EORTC QLQ-H&N35:
Pain scale from H&N35, Swallowing scale from H&N35 and Global health status/QoL scale from C30.
Pain scale includes items 31-34 from H&N 35; Swallowing scale includes items 35-38 from H&N35 and Global health status/QoL scale includes items 29-30 from C30.
The scores of these scales were averaged from the scores of the component items, transformed and analyzed on 0 - 100 scale. For pain and swallowing scales, higher scores represent worse outcome; for the global health/QoL scale, higher scores represent better outcome.
Changes in scores over time were assessed using longitudinal models.
The analyses of HRQOL are presented for the 07 May 2014 cut-off date."|From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.|RS (Only patients with observed cases (OC) values were analysed)||scores on a scale||Standard Error|Mean
841523|NCT01345682|Secondary|Health Related Quality of Life (HRQOL)- Change in Pain Scores Over Time|"The HRQOL analyses focused on pain, swallowing, and global health status measured by the European Organisation for Research and Treatment of Cancer [EORTC] quality of life questionnaires Core 30 [QLQ-C30], and head and neck cancer specific supplementary module EORTC QLQ-H&N35:
Pain scale from H&N35, Swallowing scale from H&N35 and Global health status/QoL scale from C30.
Pain scale includes items 31-34 from H&N 35; Swallowing scale includes items 35-38 from H&N35 and Global health status/QoL scale includes items 29-30 from C30.
The scores of these scales were averaged from the scores of the component items, transformed and analyzed on 0 - 100 scale. For pain and swallowing scales, higher scores represent worse outcome; for the global health/QoL scale, higher scores represent better outcome.
Changes in scores over time were assessed using longitudinal models.
The analyses of HRQOL are presented for the 07 May 2014 cut-off date."|From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.|RS (Only patients with observed cases (OC) values were analysed)||scores on a scale||Standard Error|Mean
841524|NCT01345682|Secondary|Tumour Shrinkage|"Tumour shrinkage, defined as the maximum decrease from baseline in the sum of diameters of the target lesions, as measured by central imaging. The longest diameter of target lesions was recorded, except for lymph nodes, which were measured by their short axis.
Negative values indicate a reduction in the sum of target lesion diameters and positive values an increase.
Percentage of Participants with Tumour shrinkage as per the categories (>=20% increase, >=0 − <20% increase, >0 − <30% decrease, >=30 − <50% decrease, >=50% decrease) are presented."|Tumour imaging was to be performed every 6 weeks during the first 24 weeks of treatment, and hereafter every 8 weeks (Up to 28 months)|RS (Only patients with observed cases (OC) values were analysed)||percentage of participants|||Number
841525|NCT01345682|Secondary|Disease Control (DC)|"DC is defined as the best overall response of CR, PR, stable disease (SD) and non-CR/non-PD.
CR for target lesions (TL): Disappearance of all target lesions. CR for non-target lesions (NTL): Disappearance of all non-target lesions . All lymph nodes must be non-pathological in size (<10mm short axis).
PR for TL: At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters.
Other factors which add to the overall response of an imaging timepoint as PR are as below:-
CR in TL, but non-CR/Non-PD in NTL leads to PR
CR in TL, but not evaluated NTL leads to PR
PR in TL, but non-PD NTL or not all evaluated NTL leads to PR;
SD for TL: change in the sum of diameters does not satisfy PR or PD.
SD in TL, non-PD in NTL lead to overall response of SD, provided there is no appearance of new lesions."|Tumour imaging was to be performed every 6 weeks during the first 24 weeks of treatment, and hereafter every 8 weeks (Up to 28 months)|RS||percentage of participants||95% Confidence Interval|Number
841526|NCT01345682|Secondary|Objective Response (OR)|"OR is defined as the best overall response of complete response (CR) and partial response (PR) according to RECIST version 1.1, CR for target lesions (TL): Disappearance of all target lesions. CR for non-target lesions (NTL): Disappearance of all non-target lesions. All lymph nodes must be non-pathological in size (<10mm short axis).
PR for TL: At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters.
Other factors which add to the overall response of an imaging timepoint as PR are as below:-
CR in TL, but non-CR/Non-PD in NTL leads to PR
CR in TL, but not evaluated NTL leads to PR
PR in TL, but non-PD NTL or not all evaluated NTL leads to PR;
All the above scenarios should also satisfy 'No occurrence of new lesions'."|Tumour imaging was to be performed every 6 weeks during the first 24 weeks of treatment, and hereafter every 8 weeks (Up to 28 months)|RS||percentage of participants||95% Confidence Interval|Number
841528|NCT01345682|Primary|Progression-free Survival (PFS) Based on Central Independent Review|"PFS was defined as the time from the date of randomisation to disease progression or death, whichever occurred first. The primary analysis of PFS considered PFS events as assessed by central independent review, including all data collected until the cut-off date (7 May 2014).
The date of disease progression was recorded based on RECIST version 1.1. Unequivocal progression of disease was determined if at least one of the following criteria applied:
At least 20% increase in the SoD of target lesions taking as reference the smallest SoD recorded since the treatment started, together with an absolute increase in the SoD of at least 5 mm
Appearance of one or more new lesions
Unequivocal progression of existing non-target lesions"|From randomization until disease progression, death or data cut-off (07May2014); Up to 28 months|RS||months||95% Confidence Interval|Median
841529|NCT01345721|Secondary|Number of Children Reporting Unsolicited Adverse Events After MenACWY-CRM Vaccination|The safety of MenACWY-CRM vaccine in children (who had previously received either one or two doses of MenACWY-CRM vaccine or one dose of MenC vaccine in the parent study) is assessed in terms of number of subjects reporting any unsolicited AEs (day 1 to day 7); serious AEs and AEs necessitating medical attention/or premature withdrawal (day 1 to day 28) after MenACWY-CRM vaccine.|Day 1-28 after vaccination|The analysis was done on the safety dataset.||Participants|||Number
841530|NCT01345721|Secondary|Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination|The safety and tolerability of MenACWY-CRM vaccine in children (who had previously received either one or two doses of MenACWY-CRM vaccine or one dose of MenC vaccine in the parent study) is assessed in terms of number of subjects reporting solicited local and systemic AEs after MenACWY-CRM vaccine.|Day 1-7 after vaccination|The analysis was done on the safety dataset i.e all subjects who received the study vaccine and provided some post-vaccination safety data||Participants|||Number
841531|NCT01345721|Secondary|Geometric Mean Titers Following One Dose of MenACWY-CRM Vaccine in Children Who Previously Received 1 Primary Dose of Either MenACWY-CRM or Men C Vaccine|Comparison of serum antibody titers following a one dose of MenACWY-CRM conjugate vaccine in children, who had previously received either one dose of the same vaccine or one dose of MenC vaccine in the parent study, are reported as GMTs against N. meningitidis serogroups A,C, W,Y|1 month post vaccination|The analysis was done on the per-protocol dataset||Titers||95% Confidence Interval|Geometric Mean
841532|NCT01345721|Secondary|Percentage of Subjects With Serum Bactericidal Titers ≥1:8, Who Previously Received 1 Primary Dose of Either MenACWY-CRM or Men C Vaccine|Comparison of serum antibody responses following one dose of MenACWY-CRM conjugate vaccine in children, who had previously received either one dose of the same vaccine or one dose of Men C vaccine in the parent study, is reported as percentage of subjects with hSBA titers ≥1:8 against N. meningitidis serogroups A,C,W,Y|1 month post vaccination|The analysis was done on the per-protocol dataset||Percentages||95% Confidence Interval|Number
841533|NCT01345721|Primary|Geometric Mean Titers in Children (Who Previously Received MenC Vaccine) One Month After One Dose of MenACWY-CRM Vaccine|The serum antibody titers following one dose of MenACWY-CRM conjugate vaccine in children, who had previously received one dose of MenC vaccine in the parent study, are reported as GMTs against N. meningitidis serogroups A,C,W,Y|1 month post vaccination|The analysis was done on the per-protocol dataset.||Titers||95% Confidence Interval|Geometric Mean
841534|NCT01345721|Primary|Percentage of Subjects (Who Had Previously Received MenC Vaccine) With Serum Bactericidal Antibody Titers ≥ 1:8, After One Dose of MenACWY-CRM Vaccination|The serum antibody response following a dose of MenACWY-CRM conjugate vaccine in children, who had previously received one dose of MenC vaccine in the parent study, is reported as percentage of subjects with hSBA titers ≥1:8 against N. meningitidis serogroups A,C, W,Y|1 month after vaccination|The analysis was done on the per-protocol dataset.||Percentages||95% Confidence Interval|Number
841535|NCT01345721|Primary|Geometric Mean Titers in Children,One Month After MenACWY-CRM Booster Vaccination|The serum antibody titers following a booster dose of MenACWY-CRM conjugate vaccine in children, who had previously received either one or two doses of the same vaccine in the parent study, are reported as geometric mean titers (GMTs) against N. meningitidis serogroups A,C, W,Y.|1 month post booster vaccination|The analysis was done on the per-protocol dataset.||Titers||95% Confidence Interval|Geometric Mean
841536|NCT01345721|Primary|Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:8, One Month After MenACWY-CRM Booster Vaccination|The serum antibody response following a booster dose of MenACWY-CRM conjugate vaccine in children, who had previously received either one or two doses of the same vaccine in the parent study, is reported as percentage of subjects with hSBA titers ≥1:8 against N. meningitidis serogroups A,C,W,Y.|1 month post booster|The analysis was done on the per-protocol dataset i.e All enrolled subjects who correctly received the vaccine, provided evaluable serum samples at the relevant time points (Day 28),and had no major protocol violation as defined prior to the end of the study.||Percentages||95% Confidence Interval|Number
841537|NCT01345721|Secondary|Persisting Geometric Mean Titers in Children, 13-33 Months After Primary Vaccination With Either MenACWY-CRM or MenC Vaccine|The persisting serum bactericidal antibody titers in children, 13-33 months after receiving either one or two doses of MenACWY-CRM vaccine or one dose of Men C vaccine in the parent study, are reported as GMTs against N. meningitidis serogroups A,C, W,Y|13-33 months after primary vaccination|The analysis was done on the per-protocol persistence dataset.||Titers||95% Confidence Interval|Geometric Mean
841538|NCT01345721|Primary|Percentage of Subjects With Persisting Serum Bactericidal Antibody Titers ≥1:8, Upto 13-33 Months After Primary Vaccination With Either MenACWY-CRM or MenC Vaccine|"The percentage of subjects with persisting serum bactericidal antibody (hSBA)titers ≥1:8 against Neisseria meningitidis serogroups A,C,W,Y, 13-33 months after receiving either one or two doses of MenACWY-CRM conjugate vaccine or one dose of MenC vaccine in parent study, is reported.
The functional bactericidal antibodies response against N. meningitidis serogroups was measured with the serum bactericidal assay using human complement (hSBA)"|13-33 months post primary vaccination|The analysis was done on the per-protocol persistence dataset i.e all enrolled subjects who provided evaluable serum samples at day 1 of the study and had no major protocol violation as defined prior to the end of the study.||Percentages||95% Confidence Interval|Number
841687|NCT01347580|Primary|ST-segment Elevation Resolution Pre PCI ≥70% (Co-primary Endpoint)|ST segment elevation resolution is the mean ST elevation pre-hospital minus the mean STelevation pre-PCI divided by the mean ST elevation pre-hospital. It is expressed as a percentage and split in 2 categories , complete (≥70%) versus incomplete (<70%) resolution.|Between baseline and PCI|mITT, on patients with non missing values||patients|||Number
841540|NCT01345786|Secondary|Clearance (Calculated for NOMAC Only)||blood samples were collected for NOMAC evaluation up to 144 hours postdose|"The # of plasma profiles analyzed is based on the # of single-dose administration periods actually completed (some participants discontinued without completing all 4 dosing periods).
Part 1 analyses also excluded certain data from participants who were misdosed, and Part 2 analyses excluded participants who did not receive drug."||L/h|Participants|Standard Deviation|Mean
841541|NCT01345786|Secondary|t1/2 of E2||0 hours to t1/2 (blood samples were collected for E2 evaluation up to 96 hours postdose)|"The # of plasma profiles analyzed is based on the # of single-dose administration periods actually completed (some participants discontinued without completing all 4 dosing periods).
Part 1 analyses also excluded certain data from participants who were misdosed, and Part 2 analyses excluded participants who did not receive drug."||hours|Participants|Full Range|Mean
841542|NCT01345786|Secondary|Terminal Phase Half Life (t1/2) of NOMAC||0 hours to t1/2 (blood samples were collected for NOMAC evaluation up to 144 hours postdose)|"The # of plasma profiles analyzed is based on the # of single-dose administration periods actually completed (some participants discontinued without completing all 4 dosing periods).
Part 1 analyses also excluded certain data from participants who were misdosed, and Part 2 analyses excluded participants who did not receive drug."||hours|Participants|Full Range|Mean
841543|NCT01345786|Secondary|Tmax of E2||0 hours to tmax of E2 (blood samples were collected for E2 evaluation up to 96 hours postdose)|"The # of plasma profiles analyzed is based on the # of single-dose administration periods actually completed (some participants discontinued without completing all 4 dosing periods).
Part 1 analyses also excluded certain data from participants who were misdosed, and Part 2 analyses excluded participants who did not receive drug."||hours|Participants|Full Range|Median
841544|NCT01345786|Secondary|Tmax of NOMAC||0 hours to tmax of NOMAC (blood samples were collected for NOMAC evaluation up to 144 hours postdose)|"The # of plasma profiles analyzed is based on the # of single-dose administration periods actually completed (some participants discontinued without completing all 4 dosing periods).
Part 1 analyses also excluded certain data from participants who were misdosed, and Part 2 analyses excluded participants who did not receive drug."||hours|Participants|Full Range|Median
841545|NCT01345786|Primary|Baseline Corrected Area Under the Concentration-time Curve From Time 0 to 72 Hours (AUC72) for E2|"Bioequivalence for NOMAC and E2 were tested on the primary PK parameters: Cmax, AUC(infinity), and AUClast for NOMAC; and baseline adjusted AUC72 and Cmax for E2.
AUC72 is the AUC from time 0 to 72 hours.
Blood samples for PK evaluation of E2 were collected predose (-1, -0.5, and 0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours postdose Day 1; multiple predose samples were needed to correct for endogenous levels."|0 hours to 72 hours|"The # of plasma profiles analyzed is based on the # of single-dose administration periods actually completed (some participants discontinued without completing all 4 dosing periods).
Part 1 analyses also excluded certain data from participants who were misdosed, and Part 2 analyses excluded participants who did not receive drug."||pg*h/mL|Participants|Full Range|Mean
841546|NCT01345786|Primary|Area Under the Concentration-time Curve From Time 0 to the Time of the Last Measurable Sample (AUC Last) and Area Under the Concentration-time Curve From Time 0 to Infinity (AUC Infinity) for NOMAC|"Bioequivalence for NOMAC and E2 were tested on the primary PK parameters: Cmax, AUC(infinity), and AUClast for NOMAC; and baseline adjusted AUC72 and Cmax for E2.
AUClast is the AUC from time 0 to the time of the final quantifiable sample.
AUC infinity is the AUC from time 0 to infinity.
Blood samples for PK evaluation of NOMAC were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 144 hours postdose Day 1."|0 hours to time of the last measurable sample (blood samples were collected for NOMAC evaluation up to 144 hours postdose)|"The # of plasma profiles analyzed is based on the # of single-dose administration periods actually completed (some participants discontinued without completing all 4 dosing periods).
Part 1 analyses also excluded certain data from participants who were misdosed, and Part 2 analyses excluded participants who did not receive drug."||ng*h/mL|Participants|Full Range|Mean
841547|NCT01345786|Primary|Baseline Corrected Maximum Observed Serum Concentration of E2 (Cmax of E2)|"Bioequivalence for NOMAC and E2 were tested on the primary PK parameters: Cmax, AUC(infinity), and AUClast for NOMAC; and baseline adjusted AUC72 and Cmax for E2.
Blood samples for PK evaluation of E2 were collected predose (-1, -0.5, and 0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours postdose Day 1; multiple predose samples were needed to correct for endogenous levels."|0 hours to time of maximum observed serum concentration of E2 (tmax of E2) (blood samples were collected for E2 evaluation up to 96 hours postdose)|"The # of plasma profiles analyzed is based on the # of single-dose administration periods actually completed (some participants discontinued without completing all 4 dosing periods).
Part 1 analyses also excluded certain data from participants who were misdosed, and Part 2 analyses excluded participants who did not receive drug."||pg/mL|Participants|Full Range|Mean
841548|NCT01345786|Primary|Maximum Observed Plasma Concentration of NOMAC (Cmax of NOMAC)|"Bioequivalence for NOMAC and E2 were tested on the primary PK parameters: Cmax, AUC(infinity), and AUClast for NOMAC; and baseline adjusted AUC72 and Cmax for E2.
Blood samples for pharmacokinetic (PK) evaluation of NOMAC were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 144 hours postdose Day 1."|0 hours to time of maximum observed plasma concentration of NOMAC (tmax of NOMAC) (blood samples were collected for NOMAC evaluation up to 144 hours postdose)|"The # of plasma profiles analyzed is based on the # of single-dose administration periods actually completed (some participants discontinued without completing all 4 dosing periods).
Part 1 analyses also excluded certain data from participants who were misdosed, and Part 2 analyses excluded participants who did not receive drug."||ng/mL|Participants|Full Range|Mean
841549|NCT01345929|Secondary|The Percentage of Subjects Who Have Both a Per-subject Microbiological Outcome of Eradication and a Clinical Outcome of Cure at the TOC Visit in the Microbiologically Evaluable (ME) Population.||Test of Cure Visit (7 Days [± 2 days] after completion of study drug administration)|ME: Treated patients, with baseline pathogen, complied with protocol.||percentage of subjects|||Number
841550|NCT01345929|Primary|The Percentage of Subjects Who Have Both a Per-subject Microbiological Outcome of Eradication and a Clinical Outcome of Cure at the Test of Cure (TOC) Visit in the Microbiological Modified ITT (mMITT) Population||Test of Cure Visit (7 Days [± 2 days] after completion of study drug administration)|mMITT: Treated subjects, with baseline pathogen.||percentage of subjects|||Number
841551|NCT01346059|Secondary|Need for Colectomy|Partial or complete colectomy performed within 30 days of enrollment|30 day|||Participants|||Count of Participants
841554|NCT01346072|Primary|Body Weight|Change in body weight from baseline to 24 hours after tolvaptan administration|Change over 24 hours|All patients in the Low Copeptin group were included in the analysis. One patient in the High Copeptin group had reduced renal function at baseline versus screening and transient hypovolemia during hospitalization indicative of volume depletion. This patient was excluded prior to review of blinded copeptin results and study data analysis.||Kg||Standard Deviation|Mean
841555|NCT01346072|Primary|Urine Output|Total urine output for 24 hours following tolvaptan administration|24 hours|All patients in the Low Copeptin group were included in the analysis. One patient in the High Copeptin group had reduced renal function at baseline versus screening and transient hypovolemia during hospitalization indicative of volume depletion. This patient was excluded prior to review of blinded copeptin results and study data analysis.||mL||Standard Deviation|Mean
841556|NCT01346085|Secondary|Any Adverse Event Throughout Follow-up|Among study participants there were no reports of death, post-transplantation lymphoproliferative disease, cancer, or opportunistic infections. There was no evidence of cytomegalovirus disease, infection or serological activation (CMV early antigens negative during the whole follow-up), nor of Epstein–Barr clinical and serological reactivation (all patients were antibodies anti EBV positive before transplant, as per the inclusion criteria).|up to 3 years||||||
841557|NCT01346085|Secondary|Severe Hypoglycemic Events Since Completion of Transplant||up to 3 years||||||
841558|NCT01346085|Secondary|the Reduction in Insulin Requirement Compared to Baseline||up to 3 years||||||
841559|NCT01346085|Secondary|Basal and Stimulated Blood C-peptide Levels in Response to Arginine Challenge Throughout Follow-up||up to 3 year||||||
841560|NCT01346085|Secondary|Glycated Hemoglobin Levels Throughout Follow-up||up to 3 years||||||
841561|NCT01346085|Secondary|Insulin Independence With Adequate Glycemic Control Throughout Follow-up||up to 3 years|||participants|||Number
841562|NCT01346085|Primary|The Proportion of Insulin Free Patients 3 Years After the Last Islet Infusion|Insulin independence is defined as no need for exogenous insulin, with adequate glycemic control [i.e., glycated hemoglobin <7% (normal range 3.5 - 6.0%), fasting glucose levels not exceeding 140 mg/dL (7.8 mmol/L) more than three times per week and 2-hour postprandial levels not exceeding 180 mg/dL (10 mmol/L) more than four times per week].|3 year|||participants|||Number
841563|NCT01346176|Secondary|Patient Satisfaction With Advance Care Planning.|Patients’ satisfaction with their advance care planning was assessed two months after they completed their ADs. One of two authors blinded to patients’ group assignments contacted patients by phone and administered a satisfaction survey based on the Canadian Healthcare Evaluation Project (CANHELP) questionnaire. This thirteen-item questionnaire has been validated for assessing satisfaction with end-of-life care planning. Patients were asked to indicate satisfaction with various parts of advance care planning (e.g. decisions about the use of life sustaining technologies including CPR or cardiopulmonary resuscitation, breathing machines, and dialysis) on a scale from 1 to 5, where 1 means not at all satisfied and 5 means completely satisfied. The overall average across the 13 item scale in each group is presented in the results below.|Two months after AD completion|These numbers reflect the number of patients who completed and returned and advance directive as well as completed a satisfaction interview and questionnaire with a research associate.||units on a scale||Full Range|Mean
841564|NCT01346176|Primary|Proportion of Subjects Who Select Palliative Care Options|The primary outcome variable will be the proportion of subjects that select palliative care options compared to the those who request aggressive treatment in each study arm. We will analyze the effects of manipulating default options and delays in alerting subjects to the presence of multiple default options on each selection in the ADs in order to see how default options influence decisions on general treatment goals and instructions for specific procedures.|6 months|This number was based on the number of participants who returned completed advance directive forms in each group||percentage who select palliative care||95% Confidence Interval|Number
841565|NCT01346293|Other Pre-specified|Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine|Solicited injection-site: Pain, Erythema, Swelling, Extensive Swelling of Vaccinated Limb, Change in Limb Circumference. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3 injection-site: Pain, Incapacitating, unable to perform usual activities; Erythema, Swelling, ≥50 mm; Change in limb circumference >50 mm increase over pre-vaccination measurement; Extensive limb swelling (ELS) was considered severe. Grade 3 systemic reactions: Fever ≥39.0˚C; Headache, Malaise, and Myalgia Significant, prevents daily activity.|Day 0 up to Day 28 post-final vaccination|Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set.||Participants|||Number
841566|NCT01346293|Other Pre-specified|Summary of Anti-Polio Geometric Mean Titers in Participants That Received Inactivated Poliovirus (IPV) Vaccine as a 4th and 5th Dose|Anti-Poliovirus types 1, 2, and 3 titers were measured by neutralization assay.|Day 0 (pre-booster vaccination) and Day 28 post-booster vaccination|Anti-Polio geometric mean titers were assessed in the Per-Protocol Analysis Set.||Titers||95% Confidence Interval|Geometric Mean
841567|NCT01346293|Other Pre-specified|Number of Participants With Booster Response to the Polio Antigens Following Vaccination With Inactivated Poliovirus (IPV) Vaccine as a 4th or 5th Dose|Anti-Poliovirus types 1, 2, and 3 titers were measured by neutralization assay. Four-fold rise in booster responses between groups was defined as post/pre-vaccination ≥4.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Booster responses to polio antigens following IPV vaccine as 4th or 5th dose were assessed in the Per-Protocol Analysis Set.||Participants|||Number
841568|NCT01346293|Other Pre-specified|Number of Participants With Seroprotection Against the Polio Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine|Anti-Poliovirus types 1, 2, and 3 titers were measured by neutralization assay. Seroprotection for anti-polio types was defined as antibody titers ≥1:8 dilution.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Seroprotection (antibody titers ≥1:8 dilution) against polio antigens was assessed in the Per-Protocol Analysis Set.||Participants|||Number
841641|NCT01347034|Secondary|Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) and Adverse Events (AEs)|Evaluate the safety of intratumoral injections of DCs in combination with an intensified RT regimen patients with high-grade large STS. Toxicity assessments were performed weekly to include assessments for: constitutional symptoms, fever, fatigue; common radiation side effects; special attention was paid to DC injection and biopsy related toxicity. Only treatment related SAEs and AEs are reported for this measure.|11 weeks per participant|All participants||participants|||Number
841569|NCT01346293|Other Pre-specified|Number of Participants With Seroprotection Against the Tetanus and Diphtheria Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine|Anti-Tetanus antibodies were measured by ELISA. Anti diphtheria antibodies were measured by a toxin neutralization test. Seroprotection for anti-tetanus and anti-diphtheria was defined as antibody concentrations ≥0.1 IU/ml and ≥1.0 IU/ml.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Seroprotection against tetanus and diphtheria antigens was assessed in the Per-Protocol Analysis Set.||Participants|||Number
841570|NCT01346293|Primary|Geometric Mean Concentrations of Polio Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine|Geometric mean concentrations to anti-polio were measured by enzyme-linked immunosorbent assay (ELISA).|Day 0 (pre-vaccination) and Day 28 post-vaccination|Geometric mean concentrations of poliovirus antibodies were assessed in the Per-Protocol Analysis Set.||Titers||95% Confidence Interval|Geometric Mean
841571|NCT01346293|Primary|Number of Participants With Booster Response to Polio Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine|Anti-poliovirus types 1, 2, and 3 titers were measured by neutralization assay. Booster responses were defined as participants with a pre-vaccination antibody concentration <1:8 dil, achieving a post-vaccination level ≥1:8 dil, or a pre-vaccination antibody concentration ≥1:8 dil, achieving a 4-fold response.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Anti-polio booster responses were assessed in the Per-Protocol Analysis Set.||Participants|||Number
841572|NCT01346293|Primary|Geometric Mean Concentrations of the Tetanus and Diphtheria Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine|Geometric mean concentrations to anti-tetanus and anti-diphtheria were measured by enzyme-linked immunosorbent assay (ELISA).|Day 0 (pre-vaccination) and Day 28 post-vaccination|Geometric mean concentrations of tetanus and diptheria antibodies were assessed in the Per Protocol Analysis Set.||Titers||95% Confidence Interval|Geometric Mean
841573|NCT01346293|Primary|Number of Participants With Booster Response to Tetanus and Diphtheria Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine|Anti-Tetanus antibodies were measured by enzyme-linked immunosorbent assay (ELISA). Anti-Diphtheria antibodies were measured by a toxin neutralization test. Booster responses were defined as participants with a pre-vaccination antibody concentration <0.1 IU/ml, achieving a post-vaccination level ≥0.4 IU/ml, or a pre-vaccination antibody concentration ≥0.1 IU/ml but <2.0 IU/ml, achieving a 4-fold rise rate post-vaccination, or a pre-vaccination antibody concentration ≥2.0 IU/ml, achieving a 2-fold response.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Anti-Tetanus and anti-diphtheria booster responses were assessed in the Per-Protocol Analysis Set.||Participants|||Number
841574|NCT01346293|Primary|Geometric Mean Concentrations of the Pertussis Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine|Geometric mean concentrations to pertussis antigens (pertussis toxoid [PT], filamentous hemagglutinin [FHA], pertactin [PRN], and fimbriae types 2 and 3 [FIM]) were measured by enzyme-linked immunosorbent assay (ELISA).|Day 0 (pre-vaccination) and Day 28 post-vaccination|Geometric mean concentrations were assessed in the Per-Protocol Analysis Set.||Titers||95% Confidence Interval|Geometric Mean
841575|NCT01346293|Primary|Number of Participants With Booster Response to the Pertussis Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine|Booster responses to pertussis antigens [pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN), and fimbriae types 2 and 3 (FIM)] were measured by enzyme-linked immunosorbent assay (ELISA). Booster responses were defined as participants with either a pre-vaccination antibody concentration less than lower limit of quantitation (<LLOQ), achieving a post-vaccination level ≥4X LLOQ, or pre-vaccination antibody concentrations ≥LLOQ but <4X LLOQ, achieving a 4-fold rise rate of post-vaccination, or a pre-vaccination antibody concentration ≥4X LLOQ, achieving a 2-fold response.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Anti-pertussis booster responses were assessed in the Per-Protocol Analysis Set.||Participants|||Number
841576|NCT01346397|Primary|Graft Survival|in cyclosporine group 84.6 +/- 5.8%; in tacrolimus group 86.2 +/- 4.1%|5 years|||percentage of participants||95% Confidence Interval|Number
841577|NCT01346397|Primary|Patient Survival|in cyclosporine group 96.4 +/- 2.8%; in tacrolimus group 96.3 +/- 3.4%|5 years|||percentage of participants||95% Confidence Interval|Number
841578|NCT01346475|Secondary|Duration of Genital HSV Shedding Episodes|Median duration of HSV shedding episodes, in hours, among episodes of known duration|11 weeks|||Hours|Episodes|Inter-Quartile Range|Median
841579|NCT01346475|Secondary|Number of Genital HSV Shedding Episodes|The number of HSV shedding episodes. A shedding episode is defined as any number of positive swabs preceded and followed by 2 negative swabs.|11 weeks|||Episodes|||Number
841580|NCT01346475|Secondary|Quantity of HSV Detected, Median|Median quantity of HSV detected, among swabs with any HSV detected|11 weeks|||log 10 copies/ml|swabs|Inter-Quartile Range|Median
841581|NCT01346475|Primary|Frequency of HSV-2 Total Shedding From the Genital Tract as Measured by PCR, Calculated Using a Per-day Shedding Rate in Participants Treated With High-dose Valacyclovir as Compared to Once-daily Valacyclovir.||11 weeks|Participants who collected at least one swab on each arm of the cross-over were included in the analysis.||percentage of swabs with HSV detected|Swabs||Number
841582|NCT01346488|Secondary|Number of Participants With Adverse Drug Reactions|Adverse drug reactions were defined as AEs of which a causal relationship with adalimumab could not be ruled out.|up to Week 52|Safety Analysis Set (all evaluable participants with validated CRFs)||Participants|||Count of Participants
841583|NCT01346488|Secondary|Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), and Deaths|AEs, which were defined as any untoward medical occurrence observed in participants who received adalimumab in this study, were summarized.|up to Week 52|Safety Analysis Set (all evaluable participants with validated CRFs)||Participants|||Count of Participants
841609|NCT01346592|Secondary|Number of Subjects Reporting Unsolicited Adverse Events After Vaccination|The number of subjects reporting any unsolicited adverse events (AEs) between Day 1 to Day 50, serious adverse events (SAEs), AE leading to withdrawal (WD), new onset of chronic disease(NOCD), adverse events of special interest following vaccination with aTIV or licensed comparator or TIV throughout the study (Day 1 to Day 394).|Day 1 to Day 394|Analysis was done on the safety population i.e all subjects who had received at least one study vaccine and had postvaccination safety data||Participants|||Number
841584|NCT01346488|Secondary|Change From Baseline in European Quality of Life-5 Dimensions Questionnaire (EQ-5D) Summary Index Score|The EQ-5D is a participant answered questionnaire scoring 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that essentially attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.594 to 1 (with higher scores indicating better health state). “Change” was calculated as the value at baseline minus the value at each subsequent time point.|Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48)|Participants with evaluable EQ-5D assessments; number analyzed=participants with an evaluable assessment at given time point.||units on a scale||Standard Deviation|Mean
841585|NCT01346488|Secondary|Number of Participants Per Category of the CDAI|The CDAI is a validated measure of RA disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global health assessed by the participant on a VAS from 0 to 10 (cm), and global health assessed by an investigator on a visual analogue scale from 0 to 10 (cm) were included in the CDAI score. Scores on the CDAI range from 0 (lowest disease activity) to 76 (highest disease activity). Categories were defined as: high (> 22.1), moderate (≤ 22.0 to > 10.0), low (≤ 10.0 to < 2.8), and remission (≤ 2.8).|Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48)|Participants with evaluable CDAI assessments; number analyzed=participants with an evaluable assessment at given time point.||Participants|||Count of Participants
841586|NCT01346488|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI)|The CDAI is a validated measure of RA disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global health assessed by the participant on a VAS from 0 to 10 (cm), and global health assessed by an investigator on a visual analogue scale from 0 to 10 (cm) were included in the CDAI score. Scores on the CDAI range from 0 (lowest disease activity) to 76 (highest disease activity). “Change” was calculated as the value at baseline minus the value at each subsequent time point.|Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48)|Participants with evaluable CDAI assessments; number analyzed=participants with an evaluable assessment at given time point.||units on a scale||Standard Deviation|Mean
841587|NCT01346488|Secondary|Number of Participants Per Category of the DAS28-4 ESR|DAS28-4 ESR, a combined index that measures activity of RA, was calculated based on the number of tender and swollen joints (out of 28 counted), general health evaluated by a VAS, and ESR. DAS28-4 ESR scores ranged from 0 (no disease activity) to 10 (maximal disease activity). Categories were defined as: high (> 5.1), moderate (≤ 5.1 to > 3.2), low (≤ 3.2 to ≥ 2.6), remission (< 2.6).|Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48)|Participants with evaluable DAS28-4 CRP assessments; number analyzed=participants with an evaluable assessment at given time point.||Participants|||Count of Participants
841588|NCT01346488|Secondary|Change From Baseline in DAS28-4 Erythrocyte Sedimentation Rate (ESR)|DAS28-4 ESR, a combined index that measures activity of RA, was calculated based on the number of tender and swollen joints (out of 28 counted), general health evaluated by a VAS, and ESR. DAS28-4 ESR scores ranged from 0 (no disease activity) to 10 (maximal disease activity). A decrease from Baseline in scores indicates improvement of disease activity.|Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48)|Participants with evaluable DAS28-4 ESR assessments; number analyzed=participants with an evaluable assessment at given time point.||units on a scale||Standard Deviation|Mean
841589|NCT01346488|Secondary|Number of Participants Per Category of the DAS28-4 CRP|DAS28-4 CRP was calculated using the number of tender and swollen joints (out of 28 counted), CRP level, and the participant's global assessment of disease activity via a VAS. The calculated range of DAS28-4 is 0 (no disease activity) to 10 (maximal disease activity). Categories were defined as: high (> 5.1), moderate (≤ 5.1 to > 3.2), low (≤ 3.2 to ≥ 2.6), remission (< 2.6).|Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48)|Participants with evaluable DAS28-4 CRP assessments; number analyzed=participants with an evaluable assessment at given time point.||Participants|||Count of Participants
841590|NCT01346488|Secondary|Change From Baseline in Disease Activity Score 28-4 C-Reactive Protein (DAS 28-4 CRP)|DAS28-4 CRP was calculated using the number of tender and swollen joints (out of 28 counted), CRP level, and the participant's global assessment of disease activity via a visual analog scale (VAS). The calculated range of DAS28-4 is 0 (no disease activity) to 10 (maximal disease activity). A decrease from Baseline in score indicates improvement of disease activity.|Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48)|Participants with evaluable HAQ-DI assessments; number analyzed=participants with an evaluable assessment at given time point.||units on a scale||Standard Deviation|Mean
841591|NCT01346488|Primary|Number of Participants Per Category of the HAQ-DI|The HAQ-DI is a patient-reported questionnaire specific for RA. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 (no disability) to 3 (very severe, high-dependency disability). Categories were defined as: high (> 1.5), moderate (≤ 1.5 to > 1.0), low (≤ 1.0 to > 0.5), remission (≤ 0.5 to > 0), 0 (0).|Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48)|Participants with evaluable HAQ-DI assessments; number analyzed=participants with an evaluable assessment at given time point.||Participants|||Count of Participants
841610|NCT01346592|Secondary|Number of Subjects Reporting Solicited Adverse Events After Vaccination|The number of subjects reporting any solicited local and systemic adverse events (AEs), following vaccination with aTIV or licensed comparator or TIV.|Day 1 through Day 7 after any vaccination|Analysis was done on solicited safety set i.e all subjects who had received at least one study vaccine and had provided data on post vaccination solicited AEs||Participants|||Number
841611|NCT01346592|Secondary|Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains, After One Vaccination|To demonstrate the GMTs at three weeks after one dose of aTIV are statistically significantly higher to the corresponding response's of comparator TIV and TIV.|Day 1, Day 29|Analysis was done on the FAS (Persistence).||Titers||95% Confidence Interval|Geometric Mean
841592|NCT01346488|Primary|Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score|The HAQ-DI is a patient-reported questionnaire specific for RA. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 (no disability) to 3 (very severe, high-dependency disability). A negative change from Baseline in the score indicates improvement.|Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48)|Participants with evaluable HAQ-DI assessments; number analyzed=participants with an evaluable assessment at given time point.||units on a scale||Standard Deviation|Mean
841593|NCT01346488|Primary|Change From Baseline in WPAI Questionnaire: Mean Percentage of Activity Impairment Due to RA|Activity impairment due to RA (the extent to which RA affected the ability to perform usual daily activities) is presented as the mean percentage of activity impairment, calculated as 100*scale value of WPAI question 6 (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. “Change” was calculated as the value at baseline minus the value at each subsequent time point.|Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48)|Participants with evaluable WPAI-RA assessments; number analyzed=participants with an evaluable assessment at given time point.||percentage of activity impairment||Standard Deviation|Mean
841594|NCT01346488|Primary|Change From Baseline in WPAI Questionnaire: Mean Percentage of Overall Work Productivity Impairment (OWPI) Due to RA|The mean percentage of OWPI due to RA (based on the WPAI questionnaire) is presented, calculated as: Absenteeism (%) + extent to which RA decreased productivity (%)* [number of hours worked / (number of hours of work missed due to RA + number of hours worked)]. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. “Change” was calculated as the value at baseline minus the value at each subsequent time point.|Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and at final assessment (up to Week 48)|Participants with evaluable WPAI-RA assessments; number analyzed=participants with an evaluable assessment at given time point.||percentage of OWPI||Standard Deviation|Mean
841595|NCT01346488|Primary|Change From Baseline in WPAI Questionnaire: Mean Percentage of Impairment While Working Due to RA (Presenteeism)|Presenteeism (the extent to which RA decreased productivity) is presented as the mean percentage of impairment while working due to RA, and calculated as: 100*scale value of question 5 on the WPAI (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. “Change” was calculated as the value at baseline minus the value at each subsequent time point.|Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and at final assessment (up to Week 48)|Participants with evaluable WPAI-RA assessments; number analyzed=participants with an evaluable assessment at given time point.||percentage of impairment while working||Standard Deviation|Mean
841596|NCT01346488|Primary|Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Questionnaire: Mean Percentage of Work Time Missed (Absenteeism)|Absenteeism, presented as the mean percentage of work time missed due to RA (as reported on the WPAI-RA), and calculated as: 100*number of hours of work missed due to RA / (number of hours of work missed due to RA + number of hours worked). WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. “Change” was calculated as the value at baseline minus the value at each subsequent time point.|Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of adalimumab (ADA) therapy, and at final assessment (up to Week 48)|Participants with evaluable WPAI-RA assessments; number analyzed=participants with an evaluable assessment at given time point.||percentage of work time missed||Standard Deviation|Mean
841597|NCT01346501|Secondary|Percentage of Participants With Adverse Drug Reactions and Serious Adverse Drug Reactions|Adverse drug reactions (serious and non-serious) are adverse events for which the causal relationship between adalimumab and the event could not be ruled out. Adverse event was defined as any untoward or unintended medical occurrences (including abnormal laboratory findings), signs/symptoms, or diseases of the participant receiving adalimumab, regardless of causality of adalimumab treatment. Data are presented as percentage of participants.|From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years|Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.||Percentage of participants|||Number
841598|NCT01346501|Secondary|Percentage of Participants With Modified Total Sharp Score (mTSS) ≤ 0.5 and ≤ 1.5|The mTSS, a method of assessing radiographs, was used to evaluate the level of joint destruction by disease. Digitized X-rays of hands and feet were obtained and scored on a scale ranging from 0 [no damage] to 5 [complete collapse or total destruction of joint] for erosion and 0 [no damage] to 4 [complete luxation of joint] for joint space narrowing. The scores on each task were summed and averaged to derive the total mTSS score ranging from 0 [normal] to 380 [maximal disease]. Large positive change in mTSS indicated disease progression; small positive/no change indicated slowing/halting of disease progression. The mTSS score ≤ 0.5 was defined as minimal radiographic progression. Data are presented as the percentage of the participants with mTSS ≤ 0.5 and ≤ 1.5 at the end of third year of the observation period (at Week 104 of P12-707).|3 years|The effectiveness analysis set was defined as all participants who had evaluable mTSS score during studies P12-069 and P12-707.||Percentage of participants|||Number
841612|NCT01346592|Secondary|Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Heterologous Strains|The percentage of subjects achieving seroconversion or ≥4 fold increase in HI titers from baseline, against heterologous strains, at three weeks and six months after last vaccination with aTIV or licensed comparator or TIV.|Day 50, Day 209|Subjects aged 6 through <72 months of age - Full Analyses Set (FAS) Persistence||Percentage of subjects||95% Confidence Interval|Number
841599|NCT01346501|Primary|Mean Health Assessment Questionnaire (HAQ) Score|The HAQ score was a participant-reported questionnaire that measured quality of life in terms of physical function of participants with rheumatoid arthritis. It consisted of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past seven days using the following response categories (score): without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). The scores on each task were summed and averaged to provide an overall score from 0 to 3, where 0-1 represented mild disability and 2-3 represented severe disability. Data are presented as mean HAQ score +/- standard deviation with negative scores indicating improvement.|At Week 0, Week 26, Week 52, Week 78, Week 104, Week 130, Week 156, Week 182, and Week 208|The effectiveness analysis set was defined as all participants who had evaluable HAQ score during studies P12-069 and P12-707.||Score on a scale||Standard Deviation|Mean
841600|NCT01346501|Primary|Percentage of Participants With Positive Serum Level of Matrix Metalloprotease-3 (MMP-3)|MMP-3, a proteolytic enzyme that plays a pivotal role in joint destruction in RA was assessed during the study. MMP-3 serum level < 121 ng/mL in men and < 59.7 ng/mL in women was considered as the normal value. Data are presented as the percentage of participants with MMP-3 serum level greater than the normal value.|At Week 0, Week 26, Week 52, Week 78, Week 104, Week 130, Week 156, Week 182, and Week 208|The effectiveness analysis set was defined as all participants who had evaluable MMP-3 score during studies P12-069 and P12-707.||Percentage of participants|||Number
841601|NCT01346501|Primary|Percentage of Participants With Disease Activity Score 28 - C-Reactive Protein (DAS28-CRP) Score < 3.2 After Discontinuation of Adalimumab Treatment|The DAS28-CRP, a combined index that measured Rheumatoid Arthritis (RA) disease activity, was calculated based on the number of tender joint count (28 joints), the number of swollen joint count (28 joints), overall disease activity (using visual analog scale (VAS)), erythrocyte sedimentation rate (ESR), and C-Reactive protein (CRP). The DAS28-CRP scores ranged from 0 (no disease activity) to 9 (maximal disease activity); decrease in DAS28-CRP score indicated improvement of disease. In participants who discontinued treatment with adalimumab after sustained low disease activity (defined as DAS28-CRP score <3.2) in study M06-859, the percentage of participants who maintained DAS28-CRP score < 3.2 without disease flare (defined as DAS28-CRP score ≥ 3.2) during studies P12-069 and P12-707 was calculated.|At Week 0, Week 26, Week 52, Week 78, Week 104, Week 130, and Week 156|The effectiveness analysis set was defined as all participants who had evaluable DAS28-CRP score during studies P12-069 and P12-707.||Percentage of participants|||Number
841602|NCT01346514|Secondary|Treatment Process Measures (Number of Treatment Sessions, Type of Housing Placement, and Change in Life Skills)|Analyses will explore whether treatment process variables mediate differences in outcomes between Addiction/Housing Case Management and time and attention conditions.|Baseline to 12 months|Due to the lack of differences seen in the primary housing outcomes between the AHCM and HSG conditions, tests of mediation were not completed.|||||
841603|NCT01346514|Secondary|Change in Mental Health Status in AHCM vs. HSG From Baseline to 12 Months|Determine if Addiction/Housing Case Management compared to a Housing Support Group control significantly improved mental health outcomes, as measured by the Psychiatric Composite Score (range 0 to 1, with higher scores indicating greater severity) on the Addiction Severity Index (ASI) and the Mental Component Summary (MCS, range 0 to 100 with lower scores indicating greater severity) of the SF-36, among homeless Veterans entering addiction specialty care over the 12-month study course. Negative change on the ASI Psychiatric Composite Score indicates improvement. Positive change on the SF-36 MCS indicates improvement.|Baseline to 12 months|||units on a scale||95% Confidence Interval|Mean
841604|NCT01346514|Secondary|Change in Percent of Participants Abstinent From Baseline to 12 Month Follow-up|Determine if Addiction/Housing Case Management compared to a Housing Support Group control significantly increase the percent of participants abstinent from alcohol and drugs over the past 30 days among homeless Veterans entering addiction specialty care over the 12-month study course. Positive change indicates improvement.|Baseline to 12 months|||precentage of participants||95% Confidence Interval|Number
841605|NCT01346514|Secondary|Change in Alcohol and Drug Outcomes in AHCM vs. HSG From Baseline to 12 Months|Determine if Addiction/Housing Case Management compared to a Housing Support Group control significantly improved alcohol and drug outcomes, as measured by Alcohol and Drug Composite Scores (range 0 to 1, with higher scores indicating greater severity) on the Addiction Severity Index (ASI), among homeless Veterans entering addiction specialty care over the 12-month study course. Negative change on the ASI measures indicates improvement.|Baseline to 12 months|||units on a scale||95% Confidence Interval|Mean
841606|NCT01346514|Secondary|Change in Functional Status in AHCM vs. HSG From Baseline to 12 Months|Determine if Addiction/Housing Case Management compared to a Housing Support Group control significantly improved functional status outcomes among homeless Veterans entering addiction specialty care over the 12-month study course. Functional status was measured by Medical, Employment, Family/Social, and Legal Composite Scores (range 0 to 1 with higher scores indicating greater severity) on the Addiction Severity Index (ASI) and the Physical Component Summary (PCS, range 0 to 100 with lower scores indicating greater severity) on the SF-36. Negative change on the ASI measures indicates improvement. Positive change on the SF-36 PCS indicates improvement.|Baseline to 12 months|||units on a scale||95% Confidence Interval|Mean
841607|NCT01346514|Secondary|Costs and Cost-effectiveness of AHCM vs. HSG, Baseline to 12 Months|Costs and cost-effectiveness of Addiction/Housing Case Management to the Housing Support Group condition.|Baseline to 12 months|These analyses were not completed due to the lack of differences seen in the primary study outcomes (percent days housed) and quality of life measures (SF-36).|||||
841608|NCT01346514|Primary|Percent Days Housed in AHCM vs. HSG, Baseline to 12 Months.|The primary aim is to determine whether the Addiction/Housing Case Management intervention increases percent days in long-term housing (permanent or long-term transitional) during the year following treatment entry relative to a Housing Support Group.|12 months (18 to 24 month outcomes examined in secondary analyses)|The percent of days in long-term transitional housing and/or own home was calculated for all patients using self-report and VA Homeless Operations Management and Evaluation System (HOMES) data. Individuals with no self-report or HOMES data were coded as not housed.||percent days housed||95% Confidence Interval|Mean
841654|NCT01347086|Secondary|Cmax of CD 6168 (Metabolite of Deleobuvir)|Maximum measured concentration of the analyte in plasma (CD 6168).|-2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration|The PK analysis set.||µmol/L||Geometric Coefficient of Variation|Geometric Mean
841614|NCT01346592|Secondary|Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains, at Risk/Not at Risk, by Age Sub Group-FAS|The superiority of HI antibody responses of aTIV compared to TIV and comparator TIV assessed in terms of post vaccination GMTs at three weeks after last vaccination against the three homologous vaccine strains, in subjects with a defined set of underlying medical conditions (at risk) and in healthy subjects (not at risk), by age sub group.|Day 50|Analysis was done on Full Analysis Set.||Titers||95% Confidence Interval|Geometric Mean
841615|NCT01346592|Secondary|Comparison of Antibody Responses of TIV Versus Comparator TIV in Terms of Percentage of Subjects Achieving Seroconversion or ≥4-fold Increase in HI Titer Against Homologous Strains in Subjects at Risk/Not at Risk, by Age Sub Group-FAS|The superiority of HI antibody responses of aTIV compared to TIV and comparator TIV assessed in terms of of percentage of subjects achieving seroconversion or ≥4-fold increase in HI Titer at three weeks after last vaccination against the three homologous vaccine strains in subjects with a defined set of underlying medical conditions (at risk) and healthy subjects (not at risk), by age sub group.|Day 50|Analysis was done on the Full Analysis Set.||Percentages of subjects||95% Confidence Interval|Number
841616|NCT01346592|Secondary|Comparison of Antibody Responses of aTIV Versus Comparator TIV and TIV in Terms of Percentage of Subjects Achieving Seroconversion or ≥4-fold Increase in HI Titer Against Homologous Strains in Subjects at Risk/Not at Risk, by Age Subgroup|The non-inferiority of HI antibody responses of aTIV to that of the licensed comparator TIV and to investigational TIV was assessed in terms of percentage of subjects achieving seroconversion or ≥4-fold increase in HI titers at three weeks after last vaccination against the three homologous vaccine strains in subjects with a defined set of underlying medical conditions (at risk) and in healthy subjects (not at risk) , by age sub group.|Day 50|Analysis was done on the Per Protocol Set.||Percentages of subjects||95% Confidence Interval|Number
841617|NCT01346592|Secondary|Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains, Subjects at Risk/Not at Risk, by Age Subgroup|The non-inferiority of Hemagglutination Inhibition (HI) antibody responses of aTIV compared to TIV and comparator TIV assessed in terms of post vaccination GMTs at three weeks after last vaccination against the three homologous vaccine strains, in subjects with a defined set of underlying medical conditions (at risk) and healthy subjects (not at risk), by age sub group.|Day 50|Analysis was done on the PPS.||Titers||95% Confidence Interval|Geometric Mean
841618|NCT01346592|Secondary|Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Homologous Strains|The percentage of subjects achieving seroconversion ≥4 fold increase in HI titers from baseline, against homologous strains, at three weeks and six months after vaccination with ATIV or licensed comparator or TIV.|Day 29, Day 50, Day 209|Analysis was done on FAS (Persistence)||Percentage of subjects||95% Confidence Interval|Number
841619|NCT01346592|Secondary|Percentage of Subjects With HI Titers ≥40 Against Homologous Strains, by Vaccine Group|The percentage of subjects demonstrating HI titers ≥40,against homologous strains, at three weeks and six months after vaccination with aTIV or licensed comparator or TIV.|Day 1, Day 29, Day 50, Day 209|Analysis was done on FAS (Persistence)||Percentage of subjects||95% Confidence Interval|Number
841620|NCT01346592|Secondary|Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains|The GMR of post-vaccination versus pre-vaccination HI titers against homologous strains, three weeks (day 29/day 1; day 50/day 1)and six months (day 209/day 1) after vaccination with either aTIV, licensed comparator or TIV.|Day 29, Day 50, Day 209|Analysis was done on FAS (Persistence)||Ratios||95% Confidence Interval|Geometric Mean
841621|NCT01346592|Secondary|The HI GMTs Against Homologous Strains, by Vaccine Group|The HI antibody titers against the three homologous strains following vaccination with either aTIV, licensed comparator or TIV, at three weeks and at six months after vaccination are reported as GMTs.|Day 1, Day 29, Day 50, Day 209|Analysis was done on FAS (Persistence) i.e. all subjects in the enrolled population who actually received a study vaccination, and provided evaluable serum samples at all relevant timepoints and also at day 209.||Titers||95% Confidence Interval|Geometric Mean
841622|NCT01346592|Secondary|Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers Against Homologous Strains (6 to <72 Months)-FAS|The superiority of HI antibody responses, in subjects 6 to <24 months of age, of aTIV compared to TIV and comparator TIV assessed in terms of number of subjects achieving seroconversion ≥4 fold increase in HI titers at three weeks after last vaccination against the three homologous vaccine strains.|Day 50|Analysis was done on the FAS||Percentage of subjects||95% Confidence Interval|Number
841623|NCT01346592|Secondary|Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains (6 to <72 Months)-FAS|The superiority of HI antibody responses, in subjects 6 to <72 months of age, of aTIV compared to TIV and comparator TIV assessed in terms of post vaccination GMTs at three weeks after last vaccination against the three homologous vaccine strains.|Day 1, Day 50|Analysis was done on the FAS||Titers||95% Confidence Interval|Geometric Mean
841624|NCT01346592|Secondary|Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms Percentage of Subjects Achieving Seroconversion or ≥4-fold Increase in HI Titer Against Homologous Strains (6 to <24 Months)|The superiority of HI antibody responses, in subjects 6 to <24 months of age, of aTIV compared to TIV and comparator TIV assessed in terms of number of subjects achieving seroconversion at three weeks after last vaccination against the three homologous vaccine strains.|Day 50|Analysis was done on the FAS||Percentage of subjects||95% Confidence Interval|Number
841625|NCT01346592|Secondary|Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains (6 to <24 Months)|The superiority of HI antibody responses, in subjects 6 to <24 months of age, of aTIV compared to TIV and comparator TIV assessed in terms of post vaccination GMTs at three weeks after last vaccination against the three homologous vaccine strains.|Day 1, Day 50|Analysis was done on the Full Analysis Set (FAS) i.e all enrolled subjects who received study vaccination and provided serum samples.||Titers||95% Confidence Interval|Geometric Mean
841655|NCT01347086|Secondary|Tmax of CD 6168 (Metabolite of Deleobuvir)|Time from dosing to the maximum measured concentration of the analyte in plasma (CD 6168).|-2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration|The PK analysis set.||h||Full Range|Median
841626|NCT01346592|Primary|Comparison of Antibody Responses of TIV Versus Comparator TIV in Terms of Percentage of Subjects Achieving Seroconversion or ≥4-fold Increase in HI Titer Against Homologous Strains in Subjects 6 to <36 Months of Age|The non-inferiority of HI antibody responses of TIV to that of the licensed comparator TIV assessed in terms of percentage of subjects achieving seroconversion or ≥4-fold increase in HI titers at three weeks after last vaccination against the three homologous vaccine strains.|Day 50|Subjects aged 6 through <36 months of age - Per Protocol Set (PPS).||Percentage of subjects||95% Confidence Interval|Number
841627|NCT01346592|Primary|Comparison of Antibody Responses of TIV Versus Comparator TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains (6 to <36 Months)|The non-inferiority of HI antibody responses of TIV to that of comparator TIV, in subjects aged 6 to <36 Months, assessed in terms of post vaccination GMTs at three weeks after last vaccination against the three homologous vaccine strains.|Day 1, Day 50|Analysis was done on the PPS.||Titers||95% Confidence Interval|Geometric Mean
841628|NCT01346592|Primary|Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of Percentage of Subjects Achieving Seroconversion or ≥4-fold Increase in HI Titers Against Homologous Strains|"The non-inferiority of HI antibody responses of aTIV compared to TIV and comparator TIV assessed in terms of percentage of subjects achieving seroconversion or ≥4-fold increase in HI titers at three weeks after last vaccination against the three homologous vaccine strains.
Seroconversion defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10."|Day 50|Analysis was done on the PPS.||Percentage of subjects||95% Confidence Interval|Number
841629|NCT01346592|Primary|Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains|The non-inferiority of Hemagglutination Inhibition (HI) antibody responses of aTIV compared to TIV and comparator TIV assessed in terms of post vaccination GMTs at three weeks after last vaccination against the three homologous vaccine strains.|Day 1, Day 50|Analysis was done on the Per Protocol Set (PPS) i.e all subjects in the enrolled population who correctly received the study vaccine, provided evaluable serum samples at relevant time-points and had no major protocol violations as defined prior to unblinding.||Titers||95% Confidence Interval|Geometric Mean
841630|NCT01346774|Primary|Participants With Clinically-diagnosed and Treated UTI's.|The primary endpoint was the number of participants who were clinically-diagnosed and treated for UTI whether or not results from a urine culture were available. All UTI's were confirmed via medical records.|From surgery to post-op visit, approximately 6 weeks post surgery|Analysis was run on all 160 subjects that were ascribed to an arm of the study. Data were analyzed using an intent to treat protocol.||participants||95% Confidence Interval|Number
841631|NCT01346839|Secondary|Trigger Positive Predictive Value|Positive Predictive Values of each of the triggers in identifying patients with a true delay in diagnostic evaluation. Calculated as: percentage of patients identified as trigger positive that actually had a delay.|15 months|||Percentage of participants|||Number
841632|NCT01346839|Secondary|Number of Participants Diagnosed With Cancer After Delay in Diagnostic Evaluation|Subsequent diagnosis of nonmalignant neoplasia, cancer, or death, and treatments required as a result of new cancer diagnoses after a pre-specified interval.|15 months|||Number of patients diagnosed with cancer|||Number
841633|NCT01346839|Secondary|Percentage of Cases With no Documented Justification for no Follow-up|This is a descriptive sub-analysis looking only at cases with no follow-up at the end of the follow-up period. Specifically, out of the cases that never got follow-up, this represents the percent of that subsample that had no justification in the medical record for the lack of follow-up. This is based on manual chart reviews.|15 months|||percentage with no documentation|||Number
841634|NCT01346839|Secondary|Percentage of Patients Receiving Timely Follow-up of a Red Flag Suggestive of Cancer|The percentage of patients receiving timely follow-up care, as defined by action taken by provider within appropriate pre-defined time intervals for each diagnostic clue, in both intervention and control groups.|15 months|||percentage of follow-up|||Number
841635|NCT01346839|Primary|Differences in Time to Documented Follow-up of a Red Flag Suggestive of Cancer|Differences between the intervention and control groups (based on a Cox Proportional Hazards Survival Analysis) in median time to documented follow-up of a red flag (e.g., colonoscopy performance after positive FOBT) or of a deliberate decision by the treating provider not to take follow-up action. When less than 50% of patients in either group received diagnostic evaluation (ie, medians were not reached), the point at which 40% received diagnostic evaluation was compared instead.|15 months|||Days||Inter-Quartile Range|Median
841636|NCT01346852|Secondary|Mean Number of Short-acting Beta-agonist (SABA) Canisters Used|The number of albuterol canisters dispensed is a marker that is well established in predicting future asthma events in an adult population.|January 1, 2004 to June 30, 2006: 3, 6, and 12 month follow-up periods|Ingenix Impact National Managed Care Database members who had >=1 ICD-9 code for asthma and had >= 1 controller medication or >=1 albuterol canister dispensed during the 12-month pre-index period.||canisters||Standard Deviation|Mean
841637|NCT01346852|Primary|Mean Ratio of Controller Medication to Total Asthma Medication|The ratio of controller medication (CM) to total asthma medication (AM), which is well established in predicting future asthma events in adults, was calculated as the ratio of the units of CMs used during the defined period divided by the sum of the units of CMs plus the units of inhaled short-acting beta-agonists used during the same period. A CM is defined as any inhaled corticosteroid containing medication, methylxanthines, leukotriene receptor antagonists, or cromolyn sodium. The ratio is calculated using all CM. Asthma controllers are medications used to treat asthma on a regular basis.|January 1, 2004 to June 30, 2006: 3, 6, and 12 month follow-up periods|Ingenix Impact National Managed Care Database members who had >=1 ICD-9 code for asthma and had >= 1 controller medication or >=5 albuterol canisters dispensed identified in the database during the 12-month identification period (pre-index). We tested 3 different capture/follow-up periods; thus, sample sizes varied depending capture period used.||ratio||Standard Deviation|Mean
841638|NCT01347008|Secondary|Daily Frequency of Raynaud's Phenomenon Attacks|Daily frequency of RP attacks as self registered in a 1-week diary. Any episode of pallor or cyanosis of the hand/fingers was considered as a RP attack, and patients were supposed to register the daily amount of such episodes on a 1-week diary, previously to the medical visit.|8 weeks|||number of attacks per day||Standard Deviation|Mean
841639|NCT01347008|Primary|Digital Skin Microvascular Blood Flow Measured by Laser Doppler Imaging (LDI) After Cold Stimulus.||8 weeks|||perfusion units||Standard Deviation|Mean
841642|NCT01347034|Primary|Number of Participants With Enhanced T Lymphocyte Immune Response Specific for Soft Tissue Sarcoma Tumor Associated Antigens(STS-TAAs)|Investigate the ability of an intensified radiation therapy (RT) regimen (namely, conventional RT with a high-dose hypofractionated boost) and Dendritic Cell (DC) administration to induce an enhanced T lymphocyte immune response specific for STS-TAAs. Criteria for immune response evaluation: Individual patients were considered as responders to TAAs if at any time point the response in IFN-γ ELISPOT assay was found higher than 30 spots per 200,000 cells or in proliferation assay higher than 3000 counts/min (CPM) AND the response in IFN-γ ELISPOT or proliferation assays to tumor cell lysates (TCL) or Ad-Surv was found more than 2SD higher than the response to corresponding control lysate or Ad-c at the same time point AND 2SD higher than the response to the same stimuli at a base line (before start of the treatment).|11 weeks per participant|All participants||participants|||Number
841643|NCT01347060|Secondary|Mean Number of Albuterol (Short-acting β-Agonists) Canisters Dispensed Per Pharmacy Claim Per Participant|The number of albuterol canisters dispensed was used as a surrogate marker of asthma symptoms.|Up to 7 years from July 1, 2001 to June 30, 2008|Participants contributing to the PharMetrics database (a large, multiplan insurance encounter database) who were identified in the study as having at least one pharmacy claim for fluticasone propionate/salmeterol or inhaled corticosteroids, had an ICD-9 code of 493.xx for asthma, and were at least 65 years of age within the time frame of the study.||albuterol canisters||Standard Deviation|Mean
841644|NCT01347060|Secondary|Mean Asthma-related Costs in the Post-index Period|Asthma-related costs were calculated as pharmacy costs, medical costs, and total asthma (pharmacy plus medical) costs. Medical costs were made up of asthma-related visits, hospitalizations, emergency department visits, and medical office visits. Pharmacy costs were comprised of all asthma-related medications used during the follow-up period. Medical services were identified by place of service and PharMetrics-specific confinement codes. Prescriptions were counted by 30-day fills, with fills less than 30 days rounded up to indicate one fill.|Up to 7 years from July 1, 2001 to June 30, 2008|Participants contributing to the PharMetrics database (a large, multiplan insurance encounter database) who were identified in the study as having at least one pharmacy claim for fluticasone propionate/salmeterol or inhaled corticosteroids, had an ICD-9 code of 493.xx for asthma, and were at least 65 years of age within the time frame of the study.||United States dollars||Standard Deviation|Mean
841645|NCT01347060|Primary|Mean Number of Post-index Asthma-related Events Measured Using Medical and Pharmacy Claims|Asthma-related events were defined as events with any primary ICD-9 code of 493.xx for hospitalizations, emergency department visits, and combined hospitalization/emergency department visits. The post-index period is defined as 3-12 months after either the first administration of fluticasone propionate and salmetrol or inhaled corticosteroids. Medical and pharmacy claims are recorded healthcare encounters in a large managed care administrative insurance database.|Up to 7 years from July 1, 2001 to June 30, 2008|Participants contributing to the PharMetrics database (a large, multiplan insurance encounter database) who were identified in the study as having at least one pharmacy claim for fluticasone propionate/salmeterol or inhaled corticosteroids, had an ICD-9 code of 493.xx for asthma, and were at least 65 years of age within the time frame of the study.||Asthma-related events||Standard Deviation|Mean
841646|NCT01347073|Primary|Adverse Events|Rate of adverse events during the Safety Extension portion of the protocol ( please note: HPN-100 treatment only during Safety Extension )|12 months|All patients that entered the Safety Extension were included in the analysis of adverse events||participants|||Number
841647|NCT01347073|Secondary|Hyperammonemic Crisis|Rate of HAC during pre-enrollment on NaPBA compared to HAC during HPN-100 treatment|1 year|||number of crises|||Number
841648|NCT01347073|Secondary|Frequency of Ammonia Levels Greater Than the Upper Limit of Normal (ULN) on HPN-100 Compared With NaPBA|Ammonia values were converted to SI units (umol/L) and normalized to a standard ULN of 35 umol/L prior to analysis|2 weeks|All patients who received any amount of both study medications (NaPBA and HPN-100) were included in this population, which is the primary population for analysis of efficacy and pharmacokinetic parameters.||Ammonia Values > ULN|Ammonia Values||Number
841649|NCT01347073|Secondary|Blood Ammonia|24-hour ammonia AUC of blood ammonia levels on Days 1 (NaPBA) and 10 (HPN-100) were compared. Ammonia was assessed at Hour 0 (pre-first dose, fasted), Hour 8 (~2-4 hours after lunch or the second main meal and dose of NaPBA), Hour 12 (~4 hours after the last main meal) and 24 hours post-first dose (pre-first dose on following day, fasted).|2 weeks|All patients who received any amount of both study medications (NaPBA and HPN-100) were included in this population, which is the primary population for analysis of efficacy and pharmacokinetic parameters.||umol/L*hours||Standard Deviation|Mean
841650|NCT01347073|Primary|Adverse Events|Rate of adverse events during the Switch-Over portion of the Protocol|2 weeks|All patients who received any amount of study medication were included in this population, which is the primary population for all baseline, accountability, demographic and safety analyses.||participants|||Number
841651|NCT01347086|Secondary|Cmax of CD 6168 Acylglucuronide (Metabolite of Deleobuvir)|"Maximum measured concentration of the analyte in plasma (CD 6168 Acylglucuronide).
The descriptive statistics of the arm Chinese 400mg cannot be determined due to limitation of available data above the below limit of quantification (BLQ)."|-2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration|The PK analysis set.||µmol/L||Geometric Coefficient of Variation|Geometric Mean
841652|NCT01347086|Secondary|Tmax of CD 6168 Acylglucuronide (Metabolite of Deleobuvir)|"Time from dosing to the maximum measured concentration of the analyte in plasma (CD 6168 Acylglucuronide). The descriptive statistics of the arm Chinese 400mg cannot be determined due to limitation of available data above the below limit of quantification (BLQ)."|-2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration|The PK analysis set.||h||Full Range|Median
841653|NCT01347086|Secondary|AUC0-∞ of CD 6168 Acylglucuronide (Metabolite of Deleobuvir)|"Area under the concentration-time curve of the analyte in plasma (CD 6168 Acylglucuronide) over the time interval from 0 extrapolated to infinity. The descriptive statistics of the arms Japanese 400mg, Japanese 800mg, Japanese 1200mg and Chinese 400mg cannot be determined. The reason was that there were too few data to derive a terminal elimination rate constant (slope) to calculate AUC0-∞."|-2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration|The PK analysis set.||µmol*h/L||Geometric Coefficient of Variation|Geometric Mean
841656|NCT01347086|Secondary|AUC0-∞ of CD 6168 (Metabolite of Deleobuvir)|"Area under the concentration-time curve of the analyte in plasma (CD 6168) over the time interval from 0 extrapolated to infinity. The descriptive statistics of the arms Japanese 1200mg and Chinese 400mg cannot be determined. The reason was that there were too few data to derive a terminal elimination rate constant (slope) to calculate AUC0-∞."|-2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration|The PK analysis set.||µmol*h/L||Geometric Coefficient of Variation|Geometric Mean
841657|NCT01347086|Secondary|Cmax of BI 208333 (Metabolite of Deleobuvir)|Maximum measured concentration of the analyte in plasma (BI 208333).|-2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration|The PK analysis set.||µmol/L||Geometric Coefficient of Variation|Geometric Mean
841658|NCT01347086|Secondary|Tmax of BI 208333 (Metabolite of Deleobuvir)|Time from dosing to the maximum measured concentration of the analyte in plasma (BI 208333) .|-2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration|The PK analysis set.||h||Full Range|Median
841659|NCT01347086|Secondary|AUC0-∞ of BI 208333 (Metabolite of Deleobuvir)|"Area under the concentration-time curve of the analyte in plasma (BI 208333) over the time interval from 0 extrapolated to infinity. The descriptive statistics of the arms Japanese 400mg, Japanese 800mg and Chinese 400mg cannot be determined. The reason was that there were too few data to derive a terminal elimination rate constant (slope) to calculate AUC0-∞."|-2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration|The PK analysis set.||µmol*h/L||Geometric Coefficient of Variation|Geometric Mean
841660|NCT01347086|Secondary|Cmax of Deleobuvir|Maximum measured concentration of the analyte in plasma (Deleobuvir).|-2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration|The PK analysis set.||µmol/L||Geometric Coefficient of Variation|Geometric Mean
841661|NCT01347086|Secondary|Tmax of Deleobuvir|Time from dosing to the maximum measured concentration of the analyte in plasma (Deleobuvir).|-2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration|The PK analysis set.||h||Full Range|Median
841662|NCT01347086|Secondary|AUC0-∞ of Deleobuvir|Area under the concentration-time curve of the analyte in plasma (Deleobuvir) over the time interval from 0 extrapolated to infinity (AUC0-∞).|-2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h (hours) after drug administration|The pharmacokinetic (PK) analysis set: all evaluable subjects of the treated set who provided at least 1 observation for at least 1 PK endpoint without important protocol violations relevant to the evaluation of PK.||µmol*h/L||Geometric Coefficient of Variation|Geometric Mean
841663|NCT01347086|Primary|Number of Subjects With Adverse Events as Determined by Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinanalysis and ECG|"Clinical relevant abnormalities for vital signs, blood chemistry, haematology, urinanalysis and ECG. Tolerability assessment endpoint.
New abnormal findings or worsening of baseline conditions were reported as adverse events. Adverse events were assessed through the entire trial, from signing the informed consent (within 21 days before drug administration) onwards through the observational phase until the end-of-trial-examination (within 14 days after last trial procedure)."|From signing the informed consent (within 21 days before drug administration) until 14 days after end of trial visit, upto 38 days.|The treated set.||participants|||Number
841664|NCT01347086|Primary|Number of Subjects With Drug Related Adverse Events|"Number of subjects with investigator-defined drug-related adverse events (AEs). Tolerability assessment endpoint.
The investigator assessed the possible causal relationship between all AEs and the investigational drug, considering all relevant factors, including pattern of reaction, temporal relationship, de-challenge or re-challenge, and confounding factors such as concomitant medication, concomitant diseases, and relevant history."|From first administration of study drug (drug related AEs) until 14 days after end of trial visit, upto 17 days.|Treated set (full analysis set according to the International Conference on Harmonization (ICH) E9 guideline): all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.||Participants|||Number
841665|NCT01347112|Secondary|Heavy Drinking Days at End of Treatment|Heavy drinking is defined as 5 standard alcohol drinks or greater for men and 4 standard alcohol drinks or greater for women. The number of heavy drinking days per month was determined using the timeline follow-back method.|week 12|||days||Standard Deviation|Mean
841666|NCT01347112|Secondary|Prolonged Abstinence at 24 Weeks|Prolonged abstinence is identified by a negative response to the question, “Since 2 weeks after your TQD, have you smoked any tobacco, even a puff, for 7 consecutive days or at least once each week on 2 consecutive weeks?”|week 24|||participants|||Number
841667|NCT01347112|Primary|Prolonged Smoking Abstinence at End of 12 Weeks of Varenicline Treatment|"Prolonged smoking abstinence will be identified by a negative response to the question, Since 2 weeks after your TQD, have you smoked any tobacco, even a puff, for 7 consecutive days or at least once each week on 2 consecutive weeks?”"|12 weeks|||participants|||Number
841668|NCT01347255|Secondary|Changes in Total Skin Thickness|Change in total skin thickness measured by ultrasound at end of treatment (Day 29) and individual visits (Days 8, 15, and 22) compared to baseline|Baseline and Days 8, 15, 22, and 29.|||millimetres||Standard Deviation|Mean
841669|NCT01347255|Secondary|Change From Baseline in Echo-poor Band Thickness at End of Treatment|Change in echo-poor band thickness from baseline to end of treatment, measured by ultrasound|Baseline and Day 29|||millimetres||Standard Deviation|Mean
841670|NCT01347255|Secondary|Changes in Total Clinical Score (TCS) by Visit|Change in Total Clinical Score (TCS; range from 0 (all signs absent) to 9 (all signs severe)) at individual visits (Days 4, 8, 11, 15, 22, and 25) compared to baseline.|Baseline and Days 4, 8, 11, 15, 18, 22, 25|||Scores on a scale||Standard Deviation|Mean
841671|NCT01347255|Secondary|Change in Clinical Sign Scores|"Absolute change in score of each clinical sign (erythema, scaling, infiltration) at end of treatment (Day 29) and at individual visits (Days 4, 8, 11, 15, 18, 22, and 25) compared to Baseline.
The investigator assessed the severity of the clinical signs erythema, scaling, and infiltration for each test site by using a 7-point scale (range 0 (no evidence) to 3 (severe)).
Negative changes in mean score represent improvement."|Baseline and Days 4, 8, 11, 15, 18, 22, 25, and 29 (End of Treatment)|||units on a scale||Standard Deviation|Mean
841688|NCT01347580|Primary|Thrombolysis In Myocardial Infarction (TIMI) Flow Grade 3 of MI Culprit Vessel at Initial Angiography (Co-primary Endpoint)|(TIMI) flow grade classification is used to assess coronary blood flow in acute coronary syndromes. grade 0:no reperfusion, grade 1: penetration without perfusion, grade 2: Partial reperfusion, grade 3: complete perfusion.|At initial angiography, pre PCI|mITT, on patients with non missing values||patients|||Number
841689|NCT01347632|Primary|p24 Antigen Concentration ng/mL|"The study will evaluate HIV infection and safety of cervico-vaginal tissue in women at 3 different time periods:
During a BV infection
Approximately 1 week after completing a 7-day course of metronidazole therapy
Approximately 1 month after completing the 7-day course of metronidazole therapy
You will not come in contact with HIV during this study - only your samples (after we have removed them from your vagina/cervix) come in contact with HIV."|6 weeks|||ng/mL||95% Confidence Interval|Mean
841690|NCT01341990|Primary|Mean Ex-Vivo Advancing Contact Angle|Study lens was removed from the eye according to protocol-specified procedures. The OCA15 (Optical Contact Angle) Instrument was used to observe, record, and calculate contact angle measurements. The wetting angle measurement was recorded in degrees (0-180), and a lower wetting angle measurement indicates a more wettable lens.|Day 8, 16 hours|Intent to treat.||Degrees||Standard Deviation|Mean
841691|NCT01341990|Primary|Mean Ex-Vivo Advancing Contact Angle|Study lens was removed from the eye according to protocol-specified procedures. The OCA15 (Optical Contact Angle) Instrument was used to observe, record, and calculate contact angle measurements. The wetting angle measurement was recorded in degrees (0-180), and a lower wetting angle measurement indicates a more wettable lens.|Day 1, 8 hours|Intent to Treat.||Degrees||Standard Deviation|Mean
841692|NCT01342081|Primary|Change From Baseline in Mean Diurnal IOP(Intraocular Pressure) at End of Study|Mean diurnal IOP(intraocular pressure) was calculated as an average of IOP(intraocular pressure) at 9:30 (pre-dose), 11:30 and 17:30.|Week 0(Baseline) and Week 4(End of Study)|||mmHg||Standard Deviation|Mean
841693|NCT01347710|Secondary|Diagnostic Certainty in PET MPI and SPECT MPI|Overall summary of diagnostic certainty in flurpiridaz F18 PET MPI and SPECT MPI by majority rule|60 days|All safety evaluable patients who had rest and stress flurpiridaz F 18 PET MPI and SPECT MPI procedures resulting in evaluable data, and had evaluable invasive coronary angiography||proportion of patients|||Number
841694|NCT01347710|Secondary|Image Quality of Rest and Stress (PET vs SPECT).|Overall summary of rest and stress image quality for flurpiridaz F18 PET MPI and SPECT MPI by majority rule. Value represents the number of subject images evaluated as excellent/good and fair/poor|60 days|All safety evaluable patients who had rest and stress flurpiridaz F 18 PET MPI and SPECT MPI procedures resulting in evaluable data, and had evaluable invasive coronary angiography||percent of images|||Number
841695|NCT01347710|Secondary|Overall Summary of Specificity of PET MPI vs SPECT MPI; Image Quality of Excellent or Good|Overall summary of specificity of flurpiridaz F18 PET MPI (qualitative, image quality excellent or good) vs. SPECT MPI by majority rule vs truth standard (angio >/=50% stenosis and confirmed MI). Value represents the number of true negative, i.e. True Negative: Patients with normal MPI and disease negative by the truth standard|60 days|All safety evaluable patients who had rest and stress flurpiridaz F 18 PET MPI and SPECT MPI procedures resulting in evaluable data, and had evaluable invasive coronary angiography||proportion of true negatives||95% Confidence Interval|Number
841696|NCT01347710|Primary|Diagnostic Efficacy of Flurpiridaz PET MPI Specificity Versus SPECT MPI Specificity|Diagnostic efficacy of flurpiridaz PET MPI specificity versus SPECT MPI specificity by majority rule in the detection of CAD using invasive coronary angiography as the truth standard|60 days|all safety evaluable patients who had rest and stress flurpiridaz F 18 PET MPI and SPECT MPI procedures resulting in evaluable data and had evaluable invasive coronary angiography||Proportion of true negatives||95% Confidence Interval|Number
841697|NCT01347710|Secondary|Overall Summary of Sensitivity of PET MPI vs SPECT MPI; Image Quality Excellent or Good|Overall summary of sensitivity of flurpiridaz F18 PET MPI (qualitative image quality of excellent or good) vs. SPECT MPI by majority rule vs. truth standard(angio >/=50% stenosis and confirmed MI). Value reported is the number of true positives, i.e. True Positive: Patients with abnormal MPI and disease positive by the truth standard|60 days|All safety evaluable patients who had rest and stress flurpiridaz F 18 PET MPI and SPECT MPI procedures resulting in evaluable data, and had evaluable invasive coronary angiography||proportion of true positives||95% Confidence Interval|Number
841698|NCT01347710|Secondary|Diagnositic Performance Evaluation of Multivessel Disease (PETvsSPECT).|Overall summary of specificity for identifying multi-vessel disease between flurpiridaz F18 PET MPI and SPECT MPI by majority rule vs. majority rule (angio >/=50% stenosis and confirmed MI). Value represents the number of true negative, i.e. True Negative: Patients with normal MPI and disease negative by the truth standard|60 days|All safety evaluable patients who had rest and stress flurpiridaz F 18 PET MPI and SPECT MPI procedures resulting in evaluable data, and had evaluable invasive coronary angiography||proportion of true negatives||95% Confidence Interval|Number
841699|NCT01347710|Secondary|Diagnositic Performance Evaluation of Multivessel Disease (PETvsSPECT).|Overall summary of sensitivity for identifying multi-vessel disease between flurpiridaz F18 PET MPI and SPECT MPI by majority rule vs. truth standard (angio >/=50% stenosis and confirmed MI). Value reported is the number of true positives, i.e. True Positive: Patients with abnormal MPI and disease positive by the truth standard|60 days|All safety evaluable patients who had rest and stress flurpiridaz F 18 PET MPI and SPECT MPI procedures resulting in evaluable data, and had evaluable invasive coronary angiography||proportion of true positives||95% Confidence Interval|Number
841700|NCT01347710|Secondary|Diagnostic Performance Evaluation of Localization of CAD for Specificity (PETVsSPECT).|Overall specificity of flurpiridaz F18 PET MPI in Coronary Territories (Qualitative Diagnosis) vs. SPECT MPI by majority rule vs. truth standard (angiographic stenosis greater than or equal to 50% stenosis and confirmed MI); left descending coronary artery (LAD), left circumflex artery (LCX), right coronary artery (RCA), and non - LAD. Value represents the number of true negative, i.e. True Negative: Patients with normal MPI and disease negative by the truth standard|60 days|All safety evaluable patients who had rest and stress flurpiridaz F 18 PET MPI and SPECT MPI procedures resulting in evaluable data, and had evaluable invasive coronary angiography||proportion of true negatives||95% Confidence Interval|Number
841701|NCT01347710|Secondary|Diagnostic Performance Evaluation of Localization of CAD for Sensitivity (PETVsSPECT).|Overall sensitivity of flurpiridaz F18 PET MPI in coronary territories (Qualitative Diagnosis vs. SPECT MPI by majority rule vs. truth standard (angiographic stenosis greater than or equal to 50% stenosis and confirmed MI); left descending coronary artery (LAD), left circumflex artery (LCX), right coronary artery (RCA), and non - LAD. Value reported is the number of true positives, i.e. True Positive: Patients with abnormal MPI and disease positive by the truth standard|60 days|All safety evaluable patients who had rest and stress flurpiridaz F 18 Flurpiridaz F18 PET MPI and SPECT MPI procedures resulting in evaluable data, and had evaluable invasive coronary angiography||Proportion of true positives||95% Confidence Interval|Number
841702|NCT01347710|Secondary|Diagnostic Efficacy of Flurpiridaz F18 PET MPI Specificity Versus SPECT Specificity in Subgroups: Pharmacologic Stress, Females and BMI>/=30.|Diagnostic efficacy of flurpiridaz F18 PET MPI specificity versus SPECT specificity by majority rule in the detection of CAD using invasive coronary angiography as the truth standard, in subgroups: pharmacologic stress, females and BMI >/=30. Value represents the number of true negative, i.e. True Negative: Patients with normal MPI and disease negative by the truth standard|60 days|all safety evaluable patients who had a rest and stress flurpiridaz F18 PET MPI and SPECT MPI procedures resulting in evaluable data and evaluable invasive coronary angiography||proportion of true negatives||95% Confidence Interval|Number
841703|NCT01347710|Secondary|Diagnostic Efficacy of Flurpiridaz F18 PET MPI Sensitivity Versus SPECT MPI Sensitivity in Subgroups: Pharmacologic Stress, Females and BMI>/=30.|"Diagnostic efficacy of flurpiridaz F18 PET MPI sensitivity versus SPECT MPI sensitivity by majority rule in the detection of CAD using invasive coronary angiography as the truth standard, , in subgroups: pharmacologic stress, females and BMI >/=30. Value reported is the number of true positives, i.e. True Positive: Patients with abnormal MPI and disease positive by the truth standard
I"|60 days|all safety evaluable patients who had a rest and stress flurpiridaz F18 PET MPI and SPECT MPI procedures resulting in evaluable data and evaluable invasive coronary angiography||proportion of true postives||95% Confidence Interval|Number
841704|NCT01347710|Primary|Diagnostic Efficacy of Flurpiridaz F 18 PET Myocardial Perfusion Imaging (MPI) Sensitivity Versus SPECT Myocardial Perfusion Imaging Sensitivity|Diagnostic efficacy of one day rest and stress flurpiridaz F 18 PET MPI sensitivity versus SPECT MPI sensitivity in the detection of coronary artery disease (CAD) by majority rule using invasive coronary angiography as the truth standard,|60 days|All safety evaluable patients who had rest and stress flurpiridaz F 18 PET MPI and SPECT MPI procedures resulting in evaluable data, and had evaluable invasive coronary angiography||Proportion of true positive cases||95% Confidence Interval|Number
841705|NCT01347788|Primary|Partial Response in Bone Scan From Baseline to Week 6|Bone scans will be centrally reviewed and categorized based on comparison of week 6 and baseline imaging. Partial response is defined as 30% or greater decrease in bone scan lesion area from baseline to week 6. An adaptive response design to determine the lowest effective cabozantinib dose among three dose levels (dose level +1, dose level 0 and dose level +1) will be employed.|Baseline and Week 6|||participants|||Number
841706|NCT01345058|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAE)|An Adverse Event (AE) is defined as any untoward medical occurrence (side effect) in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event that occurs after receiving the drug.|6 Months|All eligible participants. One participant in the Lacosamide + Low-Dose Levetiracetam arm did not receive study drug and is not included. One participant never confirmed taking the study medication, never followed up, and was not included in the analysis.||Participants|||Count of Participants
841707|NCT01345058|Secondary|Retention Rate|Retention rate is defined as the percentage of participants who remained on the study drug after study completion.|6 Months|All eligible participants. One participant in the Lacosamide + Low-Dose Levetiracetam arm did not receive study drug and is not included in the analysis.||percentage of participants|||Number
841708|NCT01345058|Secondary|Time to First Seizure After Therapeutic Dose is Reached|Time in days until the first seizure after the therapeutic dose is reached occurs.|6 Months|All eligible participants. One participant in the Lacosamide + Low-Dose Levetiracetam arm did not receive study drug and is not included in the analysis.||days||Full Range|Median
841709|NCT01345058|Secondary|Number of Seizure-Free Days||6 Months|All eligible participants. One participant in the Lacosamide + Low-Dose Levetiracetam arm did not receive study drug and is not included in the analysis.||days||Standard Deviation|Mean
841710|NCT01345058|Primary|Percentage of Participants Achieving Six Month Seizure Freedom|Seizure freedom is defined as having no seizures and was evaluated in the 6 month period after receiving the drug.|6 Months|All eligible participants. One participant in the Lacosamide + Low-Dose Levetiracetam arm did not receive study drug and is not included in the analysis.||percentage of participants|||Number
841711|NCT01345123|Primary|Total Medical Costs That Can be Impacted Per Member Per Month|"total medical cost paid for covered services for the subject for six months after initiation of the study. This total includes all places of service and types of covered services, including inpatient, outpatient and pharmacy.
Costs that cannot be impacted include: Costs related to Trauma and Accident, Psychiatric/Substance Abuse, Malignant Neoplasm, Maternity and Childbirth excluded"|6 months|Excluded: Subjects with claim for study-related surgery prior to intervention,claims evidence of symptomatic AIDS, organ transplant, on dialysis, Institutionalized >= 30days for psych. Subjects with less than 6 months of health plan eligible months. Spinal Stenosis not eligible for study.||Total dollars / member months||95% Confidence Interval|Mean
841712|NCT01345123|Secondary|Decision Satisfaction|Self-reported measure of subject satisfaction with decision as measured retrospectively, including how subjects feel their decision worked out and whether or not they would make the same decision again.|6 months||||||
841713|NCT01345123|Secondary|Decision Conflict|Self-reported measure of the extent to which subjects feel comfortable, supported and confident in choosing one treatment approach over others. Score computed on a scale of 1-3, where 1 = 'No', 2='Yes, somewhat', 3='Yes, completely' (3 indicates less conflict, 1 indicates most conflict) on a 4 item survey question set- asks whether respondents feel sure, have enough support, know and are clear about benefits and risks of treatment options.|12 weeks|Decision Quality Survey administered to a random sample (N=2600) of all study participants in the second study wave (N=4208): 1177 survey-eligible respondents.||units on a scale||95% Confidence Interval|Mean
841714|NCT01345123|Secondary|Knowledge|Subject self-reported knowledge about the risks and benefits of surgical options and likely outcomes with and without surgical interventions.Knowledge score calculated (score of 0-5, counting number of correct answers) for every respondent who completes at least 3 of the 5 items.|12 weeks|Decision Quality Survey administered to a random sample (N=2600) of all study participants in the second study wave (N=4208): 1177 survey-eligible respondents, 1124 received a knowledge score.||number of correct answers||95% Confidence Interval|Mean
841715|NCT01345123|Secondary|Quality of Decision Making Process|Self-reported measure of the extent to which subject interactions with providers involve discussions of the pros and cons of treatment options and provide an opportunity for subjects to have input into the decisions.|6 months||||||
841716|NCT01345123|Secondary|Concordance|Self-reported consistency of choices with goals and concerns--extent to which the treatment choices subjects make are or are not consistent with the issues they state are priorities including avoiding surgery, reducing pain and regaining function|6 months||||||
841717|NCT01345123|Secondary|Rate of Targeted Conditions Surgeries|rate of any one claims based instance of lumbar back, hip repair, hip replacement, knee repair, or knee replacement surgery|6 months|Excluded: Subjects with claim for study-related surgery prior to intervention,claims evidence of symptomatic AIDS, organ transplant, on dialysis, Institutionalized >= 30days for psych. Subjects with less than 6 months of health plan eligible months. Spinal Stenosis not eligible for study.||percentage of participants|||Number
841718|NCT01345123|Primary|Total Medical Costs Per Member Per Month|total medical cost paid for covered services for the subject for six months after initiation of the study. This total includes all places of service and types of covered services, including inpatient, outpatient and pharmacy.|6 months|Excluded: Subjects with claim for study-related surgery prior to intervention,claims evidence of symptomatic AIDS, organ transplant, on dialysis, Instituted >= 30days for psych. Subjects with less than 6 months of health plan eligible months. Spinal Stenosis not eligible for study.||Total dollars / member months||95% Confidence Interval|Mean
841719|NCT01345162|Secondary|Development of Persistent Postoperative Pain|Assessment of pain prevalence and presentation of persistant postoperative pain. Evaluation of all the patients after 1 and 3 months by phone call and with clinical re-evaluation in all patients who referred pain.|Up to 3 months||||||
841720|NCT01345162|Secondary|Assessment of Any Connections Between the Two Therapeutical Strategies and the Recurrence of Surgical Complications|"Assessment of the recurrence of surgical complications. Evaluation of all the patients after 5 days by clinical evaluation. After 1 and 3 month in the patients who refer pain.
Assessment of any difference between the two groups."|4 days postherniotomy||||||
841721|NCT01345162|Secondary|Difference in Recovering Daily Activity|Assessment of the difference in recovering daily activity in terms of NRSm (Numeric Rate Scale at movement)|4 days after surgical procedure||||||
841722|NCT01345162|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|"All adverse events (eg: PONV (postoperative nausea and vomiting), itching, dizziness, epigastralgia) are recorded.
Assessment of any difference between the two groups."|4 days postherniotoy||||||
841723|NCT01345162|Primary|Analgesic Efficacy|"percentage of patients with NRS≥4. (NRS=numeric rating scale; o quantify pain from0=no pain to 10=worst pain possible).
NRS≥4 is cosidered as suboptimal pain control worth to be treated with adjunctive analgesics. We therefore condidered the difference in percentage of patients experiencing not optimal pain control in the two groups to understand, if any, the difference in analgesic efficacy between the two drugs."|4 days postherniotomy|||percentage of patients with NRS≥4|||Number
841725|NCT02800213|Primary|Received Tidal Volume|Mean received tidal volume for 30 breaths delivered by the subjects over three minutes as measured via the RespiTrainer Advance manikin model monitor output.|3 minutes|||milliliters||95% Confidence Interval|Mean
842489|NCT02162979|Primary|Change in Duration of Dyskinesia.||2 weeks||||||
841740|NCT02600767|Primary|Absence of Malaria Parasites in Blood.|Investigators will evaluate the percentage of patients who remain free of malaria parasites in the blood during the 28-day follow-up period.|28 days|||Participants|||Count of Participants
841754|NCT02551224|Secondary|Comfort of the Mouth Pieces for Performing a Tight Seal With the Lips.|To measure in COPD patients naïve to DPIs, the comfort of the mouth pieces when performing a tight seal with the lips using the Breezhaler® and Ellipta® devices.The mean (SD) score on a scale of 1 – 5 (1 = not at all easy, 2= not very easy, 3=somewhat easy, 4=very easy, 5 = extremely easy)|6 hours|full analysis set||units on a scale||Standard Deviation|Mean
841755|NCT02551224|Primary|Patient's Preference on the Feedback Mechanisms of Dose Delivery Confirmation Using the Breezhaler® and Ellipta® Devices|"This study will measure patient’s perceptions of dose delivery, using a preference questionnaire on use of the Breezhaler® & Ellipta® devices, in COPD patients naïve to DPI devices.The mean (SD) score on a scale of 1– 5 (1 = not at all confident/not at all; 5 = extremely confident/a very great deal) 1a. How confident were you that you received the full dose of medication from your inhaler?
1=Not At All Confident, 2=Not Very Confident, 3=Somewhat Confident, 4=Confident, 5=Extremely Confident
1b. How certain were you that there was no drug remaining in the device?
1=Not At All Certain,2=Not Very Certain, 3=Somewhat Certain,4=Certain, 5=Extremely Certain
1c. To what extent did the device help you to know that you have received all the medication?
1=Not At All, 2=A Little, 3=Somewhat, 4=Very Much, 5=A Very Great Deal"|6 hours|Full analysis set||units on a scale||Standard Deviation|Mean
841756|NCT02524158|Secondary|EuroQOL 5D (EQ5D)|The EQ5D is a preference-based measure of health-related quality of life. The measure produces a single score ranging from 0 (death) to 1.00 (optimal health). Scores can be integrated with time to calculate Quality Adjusted Life Years.|baseline, 12 weeks, 6 months||11/2017||||
841757|NCT02524158|Secondary|Pittsburgh Sleep Quality Index (PSQI)|The PSQI is a validated measure of sleep quality. The global PSQI score has a range of 0-21, with higher scores indicating worse sleep quality.|baseline, 12 weeks, 6 months||11/2017||||
841758|NCT02524158|Secondary|Lumbar Spine Stabilization Endurance|Prone and supine bridge maneuvers will be used to assess core stabilization. Research staff recorded the length of time in seconds each pose is held until fatigue or pain prevents its maintenance. If patients cannot get into either one of the positions, record the respective time as zero. Recorded values range from 0 - 90 seconds in each position, with more time indicating greater core strength.|baseline, 12 weeks, 6 months||11/2017||||
841759|NCT02524158|Secondary|Lower Limb Strength and Balance|The Single Leg Stance (SLS) is a commonly used measure of both lower leg strength and balance. A total of four trials were conducted – left and right leg with both eyes open and eyes closed. Each trial will be timed from the moment the participant lifts one foot off the floor until the moment they need to place it on the floor again. If the participant is able to stand on one leg for 60 seconds the trial will be stopped and they will be asked to switch side. The average of time balanced with the left and right leg will be recorded separately for the open and closed eyes condition. Values range from 0 - 60 seconds with greater values indicating better balance.|baseline, 12 weeks, 6 months||11/2017||||
841760|NCT02524158|Secondary|Grip Strength|Grip strength in both hands of each participant will be measured using an adjustable, hydraulic grip strength dynamometer (Jamar Hydraulic Hand Dynamometer). Three trials will be conducted for each hand. In cases of current pain flare-ups or recent procedures to a hand or wrist, the affected hand is not tested, and the result of the one other hand is used. If both hands are used the best performance of two trials will be selected for each side, and the average of the left and right hand will be used for analysis. The value measured is pounds of force exerted and typically ranges from 0 - 150 lbs, with higher numbers indicating greater grip strength.|baseline, 12 weeks, 6 months||11/2017||||
841761|NCT02524158|Secondary|Range of Motion|Spinal Range of Motion (ROM) will be measured using a Saunders Digital Inclinometer, a portable device which isolates lumbar ROM (flexion and extension). The device is placed along the spine and uses a precise optical angular scanner. Forward bend angle measures how far forward and downward a person can bend at the waist, from a fully erect and/or normal standing position. The value typically ranges from 0-180 degrees, with higher values indicating greater flexibility.|baseline, 12 weeks, 6 months||11/2017||||
841762|NCT02524158|Secondary|Attendance/ Home Practice|Two indicators of the amount of yoga practiced by each participant will be used. Actual attendance of yoga sessions will be assessed using VA medical record data. Attendance can range from 0-24 sessions attended for those participants randomized to yoga. Self-reported practice of yoga at home will be assessed using a weekly participant yoga log. The self-report yoga log assesses whether they practiced yoga each day, the amount of minutes practiced, the use of instructions, the difficulty of poses, and the estimated level of physical activity or exertion.|total # of sessions attended and minutes of home practice at end of 12 week intervention||11/2017||||
841763|NCT02524158|Secondary|Fatigue Severity Scale (FSS)|Fatigue (absence of energy) will be measured with the Fatigue Severity Scale (FSS). The FSS is a self-administered instrument developed to assess the impact and severity of fatigue. It consists of 9 items describing the functional impact of fatigue on daily life rated on a scale from 1 (strongly disagree) to 7 (strongly agree) with the total fatigue score ranging from 9-63 or an average score ranging from 1.0-7.0. Higher scores reflect greater fatigue severity and less energy.|baseline, 12 weeks, 6 months||11/2017||||
841764|NCT02524158|Secondary|Self-efficacy for Managing Low Back Pain|Self-efficacy for controlling CLBP reflects levels of confidence in the ability to influence the intensity of back pain symptoms and the impact that CLBP has on daily life. The questions are based on self-efficacy items developed for the Medical Outcomes Study in mixed chronic diseases. The wording of the items has been adapted to be specific to CLBP. The measure consists of 6 items, rated on a 6-point Likert scale, with each item ranging from 0-10. The total score is the mean of the 6 items with higher scores indicating greater self-efficacy for managing CLBP.|baseline, 12 weeks, 6 months||11/2017||||
841765|NCT02524158|Secondary|Short-form 12 (SF12)|Health-related quality of life will be measured using the Short-form 12 (SF12). Based on the longer SF-36, the SF-12 was developed with the objective of finding a short yet meaningful measure of generic HRQOL or global health status. The 12 items were selected from the SF-36 and tested through a series of stages. The PCS-12 and MCS-12 show similar levels of precision to the summary scores derived from the longer 36-item measure. PCS-12 and MCS-12 scores are transformed to a 0 to 100, with higher scores indicating better quality of life.|baseline, 12 weeks, 6 months||11/2017||||
841766|NCT02524158|Secondary|Brief Anxiety Inventory (BAI)|The Brief Anxiety Inventory (BAI) measures the severity of anxiety symptoms, particularly those that distinguish anxiety from depression. The BAI consists of 21 items, is self-administered and can be completed in 5 to 10 minutes. Items are scored on a scale of 0 to 3 and are summed to generate a total score. Scores range from 0 to 63, and higher scores indicate greater depression.|baseline, 12 weeks, 6 months||11/2017||||
841767|NCT02524158|Secondary|Center for Epidemiologic Studies Short Depression Scale (CES-D 10)|Depression will be assessed using the Center for Epidemiologic Studies Short Depression Scale (CES-D 10). Derived from the full CES-D, there are 10 items that ask about the frequency of mood symptoms, rated on a 4-point Likert scale ranging from 0 (Never) to 3 (All of the Time). Scores range from 0 to 30, and higher scores indicate greater depression. A number of items are reverse-scored and a score of 10 or greater is considered depressed. Normative data on people with assorted chronic illnesses are available for comparisons.|baseline, 12 weeks, 6 months||11/2017||||
841768|NCT02524158|Secondary|Pain Interference - Brief Pain Inventory|The short version of the Brief Pain Inventory (BPI) is a self-rated questionnaire designed to assess the severity of pain and the impact of pain on daily functions in the past day and week. The BPI takes about 5 minutes to complete and has been validated with low back pain patients. It has been shown to respond to both behavioral and pharmacological pain interventions. The BPI measures severity of pain, impact of pain on daily function, location of pain, pain medications, and amount of pain relief. Items are answered utilizing a scoring algorithm, with the mean of the 7 interference items used a as a measure of pain interference. Scores range from 0-10, with higher scores indicating more pain, and when considering the change from baseline to follow-up assessments, negative scores indicate improvement.|baseline, 12 weeks, 6 months||11/2017||||
841769|NCT02524158|Secondary|Pain Intensity - Brief Pain Inventory|The short version of the Brief Pain Inventory (BPI) is a self-rated questionnaire designed to assess the severity of pain and the impact of pain on daily functions in the past day and week. The BPI takes about 5 minutes to complete and has been validated with low back pain patients. It has been shown to respond to both behavioral and pharmacological pain interventions. The BPI measures severity of pain, impact of pain on daily function, location of pain, pain medications, and amount of pain relief. Items are answered utilizing a scoring algorithm, with the mean of the 4 severity items used as measures of pain severity. Scores range from 0-10, with higher scores indicating more pain, and when considering the change from baseline to follow-up assessments, negative scores indicate improvement.|baseline to 6 months|Of the 76 participants randomized to each group, 1 participants in each group requested withdrawal of all of their data from the study. Thus, baseline characteristics, outcomes analyses, and outcomes results are reported for 75 participants.||units on a scale||95% Confidence Interval|Mean
841770|NCT02524158|Secondary|Pain Intensity - Brief Pain Inventory|The short version of the Brief Pain Inventory (BPI) is a self-rated questionnaire designed to assess the severity of pain and the impact of pain on daily functions in the past day and week. The BPI takes about 5 minutes to complete and has been validated with low back pain patients. It has been shown to respond to both behavioral and pharmacological pain interventions. The BPI measures severity of pain, impact of pain on daily function, location of pain, pain medications, and amount of pain relief. Items are answered utilizing a scoring algorithm, with the mean of the 4 severity items used as measures of pain severity. Scores range from 0-10, with higher scores indicating more pain, and when considering the change from baseline to follow-up assessments, negative scores indicate improvement.|baseline to 12 weeks|Of the 76 participants randomized to each group, 1 participants in each group requested withdrawal of all of their data from the study. Thus, baseline characteristics, outcomes analyses, and outcomes results are reported for 75 participants.||units on a scale||95% Confidence Interval|Mean
841771|NCT02524158|Primary|Roland-Morris Disability Questionnaire|The primary outcome is the change in Roland-Morris Disability Questionnaire (RMDQ) score between baseline, 12-weeks, and 6-months. The questionnaire consists of 24 questions that ask about back pain-related functional limitations experienced for a variety of daily activities . Scores can range from 0-24. Higher scores indicate more impairment, and when considering the change from baseline to follow-up assessments, negative scores indicate improvement. The scale has been shown to be reliable and is well validated. It has been used in another yoga RCT, allowing for comparisons.|baseline to 6-months|Of the 76 participants randomized to each group, 1 participants in each group requested withdrawal of all of their data from the study. Thus, baseline characteristics, outcomes analyses, and outcomes results are reported for 75 participants.||units on a scale||95% Confidence Interval|Mean
841772|NCT02524158|Primary|Roland-Morris Disability Questionnaire|The primary outcomes is the change in Roland-Morris Disability Questionnaire (RMDQ) score between baseline and 12-weeks. The questionnaire consists of 24 questions that ask about back pain-related functional limitations experienced for a variety of daily activities . Scores can range from 0-24. Higher scores indicate more impairment, and when considering the change from baseline to follow-up assessments, negative scores indicate improvement. The scale has been shown to be reliable and is well validated. It has been used in another yoga RCT, allowing for comparisons.|baseline to 12 weeks|Of the 76 participants randomized to each group, 1 participants in each group requested withdrawal of all of their data from the study. Thus, baseline characteristics, outcomes analyses, and outcomes results are reported for 75 participants.||units on a scale||95% Confidence Interval|Mean
841788|NCT02374593|Secondary|Number of Adjustments Due to Overtreatment in Subjects With Athyreosis, Ectopic and Eutopic Thyroid Glands Compared With Controls|Whether the dose adjustment was made for overtreatment was noted as based on TSH and fT4/T4 results|6 months|||dose adjustments||Standard Error|Mean
841789|NCT02374593|Primary|Dose Adjustments|Thyroid labs (TSH and fT4/T4) will be monitored per standard care: 2 weeks after initiation of levothyroxine and once monthly during the first 6 months of treatment. The number of dose adjustments required per participant during the first 6 months of treatment were recorded.|6 months|||Number of dose adjustments||Standard Error|Mean
841790|NCT02369341|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|A serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|During the entire study period (approximately 21 days for each subject)|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.||Subjects|||Number
841791|NCT02369341|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.|During the 21-day (Days 0-20) post-vaccination period.|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.||Subjects|||Number
841792|NCT02369341|Secondary|Duration of Solicited General Symptoms|Duration was defined as number of days with any grade of general symptoms.|During the 4-day (Days 0-3) post-vaccination period|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.||days||Full Range|Median
841793|NCT02369341|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Medically Attended Adverse Events (MAEs).|MAEs were defined as AEs with a medically-attended visit i.e. prompting emergency room (ER) visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. Any MAE was defined as at least one MAE experienced. Grade 3 was defined as MAEs that prevented normal activities and related was defined as MAEs assessed by the investigator to be causally related to the study vaccination.|During the entire study period (approximately 21 days for each subject).|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.||subjects|||Number
841794|NCT02369341|Secondary|Duration of Solicited Local Symptoms|Duration was defined as number of days with any grade of local symptoms.|During the 4-day (Days 0-3) post-vaccination period|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.||days||Full Range|Median
841795|NCT02369341|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed were Arthralgia, Fatigue, Gastrointestinal symptoms, Headache, Myalgia, Shivering, Sweating and Temperature (Oral). Any was defined as any general symptom reported irrespective of intensity or relationship to vaccination. Grade 3 was defined as symptoms that prevented normal activity. Related was defined as general symptom assessed by the investigator to have a causal relationship to vaccination.|During the 4-day (Days 0-3) post-vaccination period|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.||Subjects|||Number
841796|NCT02369341|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal everyday activities. Grade 3 redness and swelling was greater than 100 millimeters (mm) i.e. >100mm.|During the 4-day (Days 0-3) post-vaccination period|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.||Subjects|||Number
841797|NCT02369341|Secondary|Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Above the Cut-off Value.|SPP was defined as the number of vaccinated subjects with a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:40. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
841798|NCT02369341|Secondary|Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains.|A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination HI titer less than (<) 1:10 and a post-vaccination HI titer ≥1:40 or pre-vaccination HI titer ≥1:10 and at least a 4-fold increase in post-vaccination HI titer. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Day 21.|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
841799|NCT02369341|Secondary|MGI for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains.|MGI also known as the seroconversion factor [SCF] was defined as the fold increase in serum HI GMTs post vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Fold increase||95% Confidence Interval|Mean
841809|NCT02343003|Other Pre-specified|Medication Usage|Reduction in pain medication usage from baseline as measured by subject self-reported average daily dosage.|6 months and 12 months|17 of the 76 originally-randomized study subjects in the Cooled radiofrequency group completed this 6 month outcome. 25 of the originally-randomized 75 study subjects in the Corticosteroid injection group completed this 6 month outcome. 12 months: 17/76 in Cooled radiofrequency group and 2/75 in Corticosteroid injection group completed.||milligrams||Standard Deviation|Mean
841800|NCT02369341|Secondary|Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains.|A seroprotected subject was defined as a vaccinated subject with a serum HI titer ≥ 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Days 0 and 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
841801|NCT02369341|Secondary|Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains.|A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cutoff value of 1:10. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Days 0 and 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
841802|NCT02369341|Secondary|Humoral Immune Response for Each Vaccine Strain in Terms of HI Antibodies.|Antibody titers were expressed as GMTs. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Days 0 and 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Titers||95% Confidence Interval|Geometric Mean
841803|NCT02369341|Primary|Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains.|MGI also known as the seroconversion factor [SCF] was defined as the fold increase in serum HI GMTs post vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Fold increase||95% Confidence Interval|Geometric Mean
841804|NCT02369341|Primary|Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Above the Cut-off Value.|"SPP was defined as the number of vaccinated subjects with a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:40.
The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria)."|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
841805|NCT02369341|Primary|Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains.|A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination HI titer less than (<) 1:10 and a post-vaccination HI titer ≥1:40 or pre-vaccination HI titer ≥ 1:10 and at least a 4-fold increase in post-vaccination HI titer. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Day 21.|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
841806|NCT02369341|Primary|Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains.|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Days 0 and 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
841807|NCT02369341|Primary|Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains.|A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cutoff value of 1:10. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Days 0 and 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
841808|NCT02369341|Primary|Humoral Immune Response for Each Vaccine Strain in Terms of Haemagglutination Inhibition (HI) Antibody Titers.|Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Days 0 and 21.|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Titers||95% Confidence Interval|Geometric Mean
842318|NCT00575159|Secondary|Mean Total Urine Volume 0-24 H|Urine volume was recorded over intervals : 0-4h, 4-8h, 8-12h, 12-16h and 16- 24h on Day 1 for each dosing period. Mean total Urine volume over 24 hours was presented.|Day 1 of each treatment period|Safety Population||mL||Standard Deviation|Mean
841810|NCT02343003|Other Pre-specified|Subject Satisfaction - Number of Participants With a Global Perceived Effect Score of 5 or Greater|"Subject satisfaction as measured by the Global Perceived Effect Score at 6 months and 12 months. The study subjects’ perception of treatment effect was reflected by the Global Perceived Effect (GPE). The Global Perceived Effect is a 7-point scale: 1 point = worst ever, 2 points = much worse, 3 points = worse, 4 points = not improved but not worse, 5 points = improved, 6 points = much improved, 7 points = best ever."|6 months and 12 months|58 of the 76 originally-randomized study subjects in the Cooled radiofrequency group completed this 6 month outcome. 67 of the originally-randomized 75 study subjects in the Corticosteroid injection group completed this 6 month outcome. 12 months: 52/76 in Cooled radiofrequency group and 4/75 in Corticosteroid injection group completed.||Participants|||Count of Participants
841811|NCT02343003|Secondary|Oxford Knee Score|"Improvement in global outcome from baseline as measured by the Oxford Knee Score at 6 months and 12 months. The Oxford Knee Score is determined by a 12-question survey that measures knee function, and is scored on a scale that ranges from 0 - 48 points, with scores of 0 - 19 = severe arthritis, 20 - 29 = moderate to severe arthritis, 30 - 39 = mild to moderate arthritis, and 40 - 48 = satisfactory joint function."|6 months and 12 months|58 of the 76 originally-randomized study subjects in the Cooled radiofrequency group completed this 6 month outcome. 67 of the originally-randomized 75 study subjects in the Corticosteroid injection group completed this 6 month outcome. 12 months: 52/76 in Cooled radiofrequency group and 3/75 in Corticosteroid injection group completed.||units on a scale||Standard Deviation|Mean
841812|NCT02343003|Secondary|Numeric Rating Scale|"The number of subjects whose knee pain is reduced from baseline by ≥ 50% based on the Numeric Rating Scale (NRS) at 12 months. The NRS is an 11-point scale (0 points to 10 points), where 0 points equals no pain and 10 points equals the worst pain."|12 months|52 of the 76 originally-randomized study subjects in the Cooled radiofrequency group completed this 12 month outcome. 4 of the originally-randomized 75 study subjects in the Corticosteroid injection group completed this 12 month outcome.||Participants|||Count of Participants
841813|NCT02343003|Primary|Safety: Number of Subjects Experiencing Adverse Events Through Final Follow up.|Safety Endpoint: Number of subjects experiencing adverse events through final follow up.|6 months and 12 months|||Participants|||Count of Participants
841814|NCT02343003|Primary|Numeric Rating Scale (NRS)|"The number of subjects whose knee pain is reduced by ≥ 50% based on the Numeric Rating Scale (NRS). The NRS is an 11-point scale (0 points to 10 points), where 0 points equals no pain and 10 points equals the worst pain."|6 months|58 of the 76 originally-randomized study subjects in the Cooled radiofrequency group completed this 6 month outcome. 68 of the originally-randomized 75 study subjects in the Corticosteroid injection group completed this 6 month outcome.||Participants|||Count of Participants
841863|NCT01908829|Secondary|Percentage of Participants With at Least a 10-Point Improvement From Baseline in OAB-q Symptom Bother Score|The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). Symptom Bother score ranges from 0 (least severity) to 100 (worst severity).|Weeks 4, 8 and 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.||percentage of participants|||Number
841819|NCT02256436|Secondary|Response Duration Per RECIST 1.1 - Participants With PD-L1 Positive Tumors|For participants who demonstrated a confirmed response (CR or PR) per RECIST 1.1, response duration was defined as the time from first documented evidence of CR or PR until disease progression or death. Response duration for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. Response duration was assessed in all participants who had PD-L1 positive tumors (CPS ≥1%) based on independent radiologist review and was analyzed using the Kaplan-Meier method.|Through database cutoff date of 07-Sep-2016 (Up to approximately 20 months)|The analysis population consisted of all randomized PD-L1 positive participants, regardless of whether or not they received study treatment. Participants were included in the treatment group to which they were randomized.||Months||Full Range|Median
841820|NCT02256436|Secondary|Response Duration Per RECIST 1.1 - Participants With Strongly PD-L1 Positive Tumors|For participants who demonstrated a confirmed response (CR or PR) per RECIST 1.1, response duration was defined as the time from first documented evidence of CR or PR until disease progression or death. Response duration for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. Response duration was assessed in all participants who had strongly PD-L1 positive tumors (CPS ≥10%) based on independent radiologist review and was analyzed using the Kaplan-Meier method.|Through database cutoff date of 07-Sep-2016 (Up to approximately 20 months)|The analysis population consisted of all randomized strongly PD-L1 positive participants, regardless of whether or not they received study treatment. Participants were included in the treatment group to which they were randomized.||Months||Full Range|Median
841821|NCT02256436|Secondary|Response Duration Per RECIST 1.1 - All Participants|For participants who demonstrated a confirmed response (CR or PR) per RECIST 1.1, response duration was defined as the time from first documented evidence of CR or PR until disease progression or death. Response duration for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. Response duration was assessed in all participants based on independent radiologist review and was analyzed using the Kaplan-Meier method.|Through database cutoff date of 07-Sep-2016 (Up to approximately 20 months)|The analysis population consisted of all randomized participants who demonstrated a confirmed response (CR or PR) per RECIST 1.1, regardless of whether or not they received study treatment. Participants were included in the treatment group to which they were randomized.||Months||Full Range|Median
841822|NCT02256436|Secondary|Number of Participants Who Discontinued Study Treatment Due to an AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of study treatment. The number of participants who discontinued study treatment due to an AE was assessed.|Up to approximately 20 months|The analysis population consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received.||Participants|||Number
841823|NCT02256436|Secondary|Number of Participants Who Experienced an Adverse Event (AE)|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of study treatment. Participants were monitored for the occurrence nonserious AEs for up to 30 days after last dose of study treatment and for serious AEs for up to 90 days after last dose of study treatment. The number of participants who experienced an AE was assessed.|Up to approximately 23 months|The analysis population consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received.||Participants|||Number
841824|NCT02256436|Secondary|ORR Per Modified RECIST - All Participants|ORR per modified RECIST was defined as the percentage of participants in the analysis population who had a Complete Response (irCR: complete disappearance of all lesions [and no new lesions] confirmation by a repeat, consecutive assessment no less than 4 weeks from the date first documented) or a Partial Response (irPR: decrease in tumor burden ≥50% relative to baseline confirmed by a consecutive assessment at least 4 weeks after first documentation). ORR per modified RECIST was assessed by blinded independent radiologist review in all participants up through the database cutoff date of 07-Sep-2016.|Through database cutoff date of 07-Sep-2016 (Up to approximately 20 months)|The analysis population consisted of all randomized participants, regardless of whether or not they received study treatment. Participants were included in the treatment group to which they were randomized.||Percentage of Participants||95% Confidence Interval|Number
841864|NCT01908829|Secondary|Percentage of Participants With a Mean of at Least 8 Micturitions Per 24 Hours at Baseline and Less Than 8 Micturitions Per 24 Hours Postbaseline|Micturitions were defined as voluntary urinations (excluding incontinence only episodes).|Weeks 4, 8 and 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.||percentage of participants|||Number
841865|NCT01908829|Secondary|Percentage of Participants With Zero Incontinence Episodes Postbaseline|Incontinence was defined as any involuntary leakage of urine.|Weeks 4, 8 and 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.||percentage of participants|||Number
841825|NCT02256436|Secondary|PFS Per Modified RECIST - All Participants|PFS was defined as the time from randomization to the first documented disease progression, or death due to any cause, whichever occurred first. Per modified (immune-related [ir]) RECIST, progressive disease (irPD) was defined as: increase in tumor burden ≥25% relative to minimum recorded tumor burden confirmation by a repeat, consecutive assessment no less than 4 weeks from the date first documented. PFS per modified RECIST was assessed by blinded independent radiologist review in all randomized participants up through the database cutoff date of 07-Sep-2016.|Through database cutoff date of 07-Sep-2016 (Up to approximately 20 months)|The analysis population consisted of all randomized participants, regardless of whether or not they received study treatment. Participants were included in the treatment group to which they were randomized.||Months||95% Confidence Interval|Median
841826|NCT02256436|Secondary|ORR Per RECIST 1.1 - Participants With PD-L1 Positive Tumors|ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. ORR was assessed by blinded independent radiologist review in participants with PD-L1 positive tumors (CPS ≥1%) up through the database cutoff date of 07-Sep-2016.|Through database cutoff date of 07-Sep-2016 (Up to approximately 20 months)|The analysis population consisted of all randomized PD-L1 positive participants, regardless of whether or not they received study treatment. Participants were included in the treatment group to which they were randomized.||Percentage of Participants||95% Confidence Interval|Number
841827|NCT02256436|Secondary|ORR Per RECIST 1.1 - Participants With Strongly PD-L1 Positive Tumors|ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. ORR was assessed by blinded independent radiologist review in participants with strongly PD-L1 positive tumors (CPS ≥10%) up through the database cutoff date of 07-Sep-2016.|Through database cutoff date of 07-Sep-2016 (Up to approximately 20 months)|The analysis population consisted of all randomized strongly PD-L1 positive participants, regardless of whether or not they received study treatment. Participants were included in the treatment group to which they were randomized.||Percentage of Participants||95% Confidence Interval|Number
841828|NCT02256436|Secondary|Objective Response Rate (ORR) Per RECIST 1.1 - All Participants|ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. ORR was assessed by blinded independent radiologist review in all participants up through the database cutoff date of 07-Sep-2016.|Through database cutoff date of 07-Sep-2016 (Up to approximately 20 months)|The analysis population consisted of all randomized participants, regardless of whether or not they received study treatment. Participants were included in the treatment group to which they were randomized.||Percentage of Participants||95% Confidence Interval|Number
841829|NCT02256436|Primary|PFS Per RECIST 1.1 - Participants With PD-L1 Positive Tumors|PFS was defined as the time from randomization to the first documented disease progression, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered PD. PFS per RECIST 1.1 was assessed by blinded independent radiologist review in all participants who had PD-L1 positive tumors (CPS ≥1%) up through the database cutoff date of 07-Sep-2016.|Through database cutoff date of 07-Sep-2016 (Up to approximately 20 months)|The analysis population consisted of all randomized PD-L1 positive participants, regardless of whether or not they received study treatment. Participants were included in the treatment group to which they were randomized.||Months||95% Confidence Interval|Median
841830|NCT02256436|Primary|OS - Participants With PD-L1 Positive Tumors|OS was defined as the time from randomization to death due to any cause. For the purposes of this study, participants with PD-L1 CPS ≥1% were considered to have a PD-L1 positive tumor status. OS was assessed in all participants who had PD-L1 positive tumors (CPS ≥1%) up through the database cutoff date of 07-Sep-2016.|Through database cutoff date of 07-Sep-2016 (Up to approximately 20 months)|The analysis population consisted of all randomized PD-L1 positive participants, regardless of whether or not they received study treatment. Participants were included in the treatment group to which they were randomized.||Months||95% Confidence Interval|Median
841831|NCT02256436|Primary|PFS Per RECIST 1.1 - Participants With Strongly PD-L1 Positive Tumors|PFS was defined as the time from randomization to the first documented disease progression, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered PD. PFS per RECIST 1.1 was assessed by blinded independent radiologist review in all participants who had strongly PD-L1 positive tumors (CPS ≥10%) up through the database cutoff date of 07-Sep-2016.|Through database cutoff date of 07-Sep-2016 (Up to approximately 20 months)|The analysis population consisted of all randomized strongly PD-L1 positive participants, regardless of whether or not they received study treatment. Participants were included in the treatment group to which they were randomized.||Months||95% Confidence Interval|Median
841832|NCT02256436|Primary|OS - Participants With Strongly PD-L1 Positive Tumors|OS was defined as the time from randomization to death due to any cause. For the purposes of this study, participants with a programmed cell death-ligand 1 (PD-L1) combined proportion score (CPS) ≥10% were considered to have a strongly PD-L1 positive tumor status. The OS was assessed in all participants who had strongly PD-L1 positive tumors (CPS ≥10%) up through the database cutoff date of 07-Sep-2016.|Through database cutoff date of 07-Sep-2016 (Up to approximately 20 months)|The analysis population consisted of all randomized strongly PD-L1 positive participants, regardless of whether or not they received study treatment. Participants were included in the treatment group to which they were randomized.||Months||95% Confidence Interval|Median
841866|NCT01908829|Secondary|Percentage of Participants With at Least a 50% Decrease From Baseline in Mean Number of Incontinence Episodes Per 24 Hours|Incontinence was defined as any involuntary leakage of urine.|Weeks 4, 8 and 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.||percentage of participants|||Number
841833|NCT02256436|Primary|Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - All Participants|PFS was defined as the time from randomization to the first documented disease progression, or death due to any cause, whichever occurred first. Per RECIST 1.1, progressive disease (PD) was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered PD. The PFS per RECIST 1.1 was assessed by blinded independent radiologist review in all participants up through the database cutoff date of 07-Sep-2016.|Through database cutoff date of 07-Sep-2016 (Up to approximately 20 months)|The analysis population consisted of all randomized participants, regardless of whether or not they received study treatment. Participants were included in the treatment group to which they were randomized.||Months||95% Confidence Interval|Median
841834|NCT02256436|Primary|Overall Survival (OS) - All Participants|OS was defined as the time from randomization to death due to any cause. The OS was assessed in all participants up through the database cutoff date of 07-Sep-2016.|Through database cutoff date of 07-Sep-2016 (Up to approximately 20 months)|The analysis population consisted of all randomized participants, regardless of whether or not they received study treatment. Participants were included in the treatment group to which they were randomized.||Months||95% Confidence Interval|Median
841867|NCT01908829|Secondary|Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC)|The PGIC was a 2-part questionnaire, assessing both the change in the participant’s overall condition (Patient Impression in General Health (PIBS)) and change in bladder condition since the start of the study (Patient Impression in General Health (PIGH)) (from very much worse to very much improved). The CGIC was a single questionnaire assessing the participant’s change in bladder condition since the beginning of the study (Clinician Impression in Bladder Symptoms (CIBS)).|End of treatment (up to 12 weeks)|LOCF was used for EoT. The analysis population consisted of the FAS.||participants|||Number
841868|NCT01908829|Secondary|Change From Baseline in Patient Perception Bladder Control (PPBC) Score|The PPBC was a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. PPBC score: 1-no problem, 2- some very minor problems, 3-some minor problems, 4-moderate problems, 5-severe problems, 6-many severe problems.|Baseline and weeks 4, 8 & 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.||units on a scale||Standard Error|Least Squares Mean
841869|NCT01908829|Secondary|Change From Baseline in Treatment Satisfaction - Visual Analogue Scale (TS-VAS) Score|The TS-VAS rated participant satisfaction with treatment on a scale from 0 (No, not at all) to 10 (Yes, completely).|Baseline and weeks 4, 8 & 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.||units on a scale||Standard Error|Least Squares Mean
841858|NCT01908829|Secondary|Change From Baseline in Post Void Residual (PVR) Volume|PVR Volume was assessed by bladder scan.|Baseline and weeks 4, 8 & 12|The analysis population consisted of the SAF with data available at each time point.||mL||Standard Deviation|Mean
841859|NCT01908829|Secondary|Number of Participants With Adverse Events (AEs)|AE was defined as any untoward medical occurrence in a participant administered a study drug or has undergone study procedures & which does not necessarily have a causal relationship with this treatment. Treatment-Emergent Adverse Event (TEAE) referred to an adverse event which started or worsened in the period from first double-blind medication intake until 30 days after the last double-blind medication intake.|From first dose of double blind treatment until 30 days after last dose (up to 16 weeks)|The analysis population consisted of the Safety Analysis Set, the SAF comprised all randomized participants who received at least 1 dose of double-blind treatment.||Participants|||Count of Participants
841860|NCT01908829|Secondary|Percentage of Participants With Major (at Least 2-Point) Improvement From Baseline in PPBC|The PPBC was a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition.|Weeks 4, 8 and 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.||percentage of participants|||Number
841861|NCT01908829|Secondary|Percentage of Participants With at Least a 1-Point Improvement From Baseline in PPBC|The PPBC was a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition.|Weeks 4, 8 and 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.||percentage of participants|||Number
841862|NCT01908829|Secondary|Percentage of Participants With at Least a 10-Point Improvement From Baseline in HRQL Total Score|HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life).|Weeks 4, 8 and 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.||percentage of participants|||Number
841870|NCT01908829|Secondary|Change From Baseline in OAB-q HRQL Subscale Score: Social Interaction|The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life).|Baseline and weeks 4, 8 & 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.||units on a scale||Standard Error|Least Squares Mean
841871|NCT01908829|Secondary|Change From Baseline in OAB-q HRQL Subscale Score: Sleep|The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life).|Baseline and weeks 4, 8 & 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.||units on a scale||Standard Error|Least Squares Mean
841872|NCT01908829|Secondary|Change From Baseline in OAB-q HRQL Subscale Score: Concern|The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life).|Baseline and weeks 4, 8 & 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.||units on a scale||Standard Error|Least Squares Mean
841873|NCT01908829|Secondary|Change From Baseline in OAB-q HRQL Subscale Score: Coping|The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life).|Baseline and weeks 4, 8 & 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.||units on a scale||Standard Error|Least Squares Mean
841874|NCT01908829|Secondary|Change From Baseline in OAB-q Health-Related Quality of Life (HRQL) Total Score|The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life).|Baseline and weeks 4, 8 & 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.||units on a scale||Standard Error|Least Squares Mean
841875|NCT01908829|Secondary|Change From Baseline in Overactive Bladder Symptom (OAB-q) Symptom Bother Score|The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). Symptom Bother score ranges from 0 (least severity) to 100 (worst severity).|Baseline and weeks 4, 8 & 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.||units on a scale||Standard Error|Least Squares Mean
841876|NCT01908829|Secondary|Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression|The EQ-5D is an international, standardized, nondisease specific instrument for describing and valuing health status. It has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels: level 1=no problem or none; level 2=slight problems; level 3=moderate problems; level 4=severe problems; level 5=unable to perform activity.|Baseline and EoT (up to 12 weeks)|LOCF was used for EoT. The analysis population consisted of the FAS.||participants|||Number
841877|NCT01908829|Secondary|Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort|The EQ-5D is an international, standardized, nondisease specific instrument for describing and valuing health status. It has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels: level 1=no problem or none; level 2=slight problems; level 3=moderate problems; level 4=severe problems; level 5=unable to perform activity.|Baseline and EoT (up to 12 weeks)|LOCF was used for EoT. The analysis population consisted of the FAS.||participants|||Number
841878|NCT01908829|Secondary|Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities|The EQ-5D is an international, standardized, nondisease specific instrument for describing and valuing health status. It has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels: level 1=no problem or none; level 2=slight problems; level 3=moderate problems; level 4=severe problems; level 5=unable to perform activity.|Baseline and EoT (up to 12 weeks)|LOCF was used for EoT. The analysis population consisted of the FAS.||participants|||Number
841879|NCT01908829|Secondary|Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care|The EQ-5D is an international, standardized, nondisease specific instrument for describing and valuing health status. It has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels: level 1=no problem or none; level 2=slight problems; level 3=moderate problems; level 4=severe problems; level 5=unable to perform activity.|Baseline and EoT (up to 12 weeks)|LOCF was used for EoT. The analysis population consisted of the FAS.||participants|||Number
841880|NCT01908829|Secondary|Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility|The EQ-5D is an international, standardized, nondisease specific instrument for describing and valuing health status. It has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels: level 1=no problem or none; level 2=slight problems; level 3=moderate problems; level 4=severe problems; level 5=unable to perform activity.|Baseline and EoT (up to 12 weeks)|LOCF was used for EoT. The analysis population consisted of the FAS.||participants|||Number
841881|NCT01908829|Secondary|Number of Nocturia Episodes Reported Over 3-Day Diary|The number of nocturia episodes was defined as the number of times a participant urinated (excluding incontinence only episodes) during sleeping time during the 3-day micturition diary period. This was calculated using the sum of each nocturia episode recorded on valid diary days during the 3-day micturition diary period.|Weeks 4, 8 and 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point. Only participants with at least one nocturia episode reported in baseline diary were included.||nocturia episodes||Standard Error|Mean
841882|NCT01908829|Secondary|Change From Baseline in Mean Number of Nocturia Episodes|Mean number of nocturia episodes was defined as the number of times a participant urinated (excluding incontinence only episodes) while sleeping during the 3-day diary period, divided by the number of valid diary days during the diary period. Night time episode of incontinence only was not considered a nocturia episode. Nocturia episodes were counted for each micturition record which occurred between the date/time of going to bed with intention to sleep and the date/time of getting up with intention to stay awake on a valid diary day & which was accompanied by a sleep interruption. Nocturia only determined for those who were not night-shift workers.|Baseline and weeks 4, 8 & 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point. Only participants with at least one nocturia episode reported in baseline diary were included.||nocturia episodes||Standard Error|Least Squares Mean
841883|NCT01908829|Secondary|Number of Pads Used During the 3-Day Diary|The number of pads used was defined as the number of times a participant recorded a new pad used during the 3-day micturition diary period. This was calculated using the sum of each record with new pad checked. Only records with new pad checked on a valid diary day were counted.|Weeks 4, 8 and 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point. Only participants who reported use of at least one pad in baseline diary were included.||pads||Standard Error|Mean
841884|NCT01908829|Secondary|Change From Baseline in Mean Number of Pads Per 24 Hours|The mean number of pads per 24 hours was defined as the average number of times a participant recorded a new pad used per day during the 3-day micturition diary period. This was calculated using the number of new pads used during valid diary days during the 3-day micturition diary period divided by the number of valid diary days during the 3-day micturition diary period.|Baseline and weeks 4, 8 & 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point. Only participants with reported use of at least one pad reported in baseline diary were included.||pads||Standard Error|Least Squares Mean
841885|NCT01908829|Secondary|Change From Baseline in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours|An urgency episode was defined as the complaint of a sudden, compelling desire to pass urine, which is difficult to defer. The mean number of urgency episodes (severity of 3 or 4) per 24 hours was defined as the average number of times a participant recorded an urgency episode (severity of 3 or 4) with or without incontinence per day during the 3-day micturition diary period. Measured using the PPIUS scale. This was calculated using the sum of each record with an urgency episode (severity of 3 or 4) recorded on a valid diary day divided by the number of valid diary days during the 3-day micturition diary period.|Baseline and weeks 4, 8 & 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point. Only participants with at least one urgency episode reported in baseline diary were included.||urgency episodes||Standard Error|Least Squares Mean
841886|NCT01908829|Secondary|Number of UI Episodes Reported During the 3-Day Diary|Number of UI episodes was calculated using the number of UI episodes recorded on valid diary days during the 3-day micturition diary period. NOTE: Only urgency incontinence episodes recorded on a valid diary day were counted.|Weeks 4, 8 and 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point. Only participants with at least one UI episode reported in baseline diary were included.||UI episodes||Standard Error|Mean
841887|NCT01908829|Secondary|Change From Baseline in Mean Number of Urgency Incontinence (UI) Episodes Per 24 Hours|UI was defined as the complaint of involuntary urine leakage accompanied by or immediately preceded by urgency. UI was measured using the Patient Perception of Intensity of Urgency Scale (PPIUS), a patient reported outcome validated 5-point categorical scale rating the degree of associated urinary urgency severity (0=No urgency, I felt no need to empty my bladder, but did so for other reasons. 1=Mild, I could postpone voiding as long as necessary, without fear of wetting myself. 2= Moderate, I could postpone voiding for a short while, without fear of wetting myself. 3=Severe, I could not postpone voiding, but had to rush to the toilet in order not to wet myself. 4=Urgency incontinence, I leaked before arriving to the toilet). One urgency incontinence episode was counted for each record of the diary in which the following occurred: incontinence episode or ‘both’ was recorded & severity of urinary urgency recorded was 3 or 4.|Baseline and weeks 4, 8 & 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point. Only participants with at least one UI episode reported in baseline diary were included.||UI episodes||Standard Error|Least Squares Mean
841888|NCT01908829|Secondary|Change From Baseline to EoT in Corrected Micturition Frequency (CMF)|CMF was defined as the mean number of micturitions per 24 hours that participants would have at EoT if their fluid intake had remained unchanged since baseline. This was calculated by the MVV per Micturition at baseline multiplied by the mean number of micturitions per 24 hours at baseline divided by the MVV per micturition at EoT.|Baseline and EoT (up to 12 weeks)|LOCF was used. The analysis population consisted of the FAS.||micturitions||Standard Error|Least Squares Mean
841889|NCT01908829|Secondary|Change From Baseline in Mean Volume Voided (MVV) Per Micturition|MVV per micturition was defined as MVV (mL) per micturition during last 3 days of the 3-day micturition diary period. MVV per micturition was calculated as the sum of each volume voided for each record with volume voided > 0 on valid diary days divided by the total number of records with a volume voided > 0 on valid diary days during the 3-day micturition diary period.|Baseline and weeks 4, 8 & 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.||mL||Standard Error|Least Squares Mean
841890|NCT01908829|Secondary|Number of Incontinence Episodes Reported During the 3-Day Diary|The number of incontinence episodes (complaint of any involuntary leakage of urine) per day was derived from total number of incontinence episodes on valid diary days recorded during the 3-day micturition diary period.|Weeks 4, 8 and 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.||incontinence episodes||Standard Error|Mean
841891|NCT01908829|Secondary|Change From Baseline in Mean Number of Micturitions Per 24 Hours|The average number of micturitions (voluntary urinations (excluding incontinence only episodes)) per 24 hours was derived from number of micturitions recorded on valid diary days during the 3-day micturition diary period divided by the number of valid diary days during the 3-day micturition diary period (excluding incontinence only episodes).|Baseline and weeks 4, 8 & 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.||micturitions||Standard Error|Least Squares Mean
841892|NCT01908829|Secondary|Change From Baseline to Weeks 4, 8 & 12 in Mean Number of Incontinence Episodes Per 24 Hours|The mean number of incontinence episodes (complaint of any involuntary leakage of urine) per day was derived from number of incontinence episodes recorded on valid diary days during the 3-day micturition diary period divided by the number of valid diary days during the 3-day micturition diary period.|Baseline and weeks 4, 8 & 12|The analysis population consisted of the FAS with data available at each time point.||incontinence episodes||Standard Error|Least Squares Mean
841893|NCT01908829|Primary|Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours|The mean number of incontinence episodes (complaint of any involuntary leakage of urine) per day was derived from number of incontinence episodes recorded on valid diary days during the 3-day micturition diary period divided by the number of valid diary days during the 3-day micturition diary period. The analysis population consisted of the Full Analysis Set (FAS) which comprised of all the Randomized Analysis Set's (RAS) participants who met the following criteria: took at least 1 dose of double-blind study drug after randomization, reported at least 1 micturition in the baseline diary & at least 1 micturition postbaseline & reported at least 1 incontinence episode in the baseline diary. For participants who withdrew before EoT (week 12) and have no measurement available for that diary period, the Last Observation Carried Forward (LOCF) value during the double-blind study period was used as EoT value to derive the primary variable.|Baseline and end of treatment (up to 12 weeks)|The analysis population consisted of the FAS. LOCF was used for EoT.||incontinence episodes||Standard Error|Least Squares Mean
841894|NCT01884597|Secondary|Fundus Clinical Findings|Decrease in subretinal hemorrhage or exudates as measured by mean size as noted on fundus photography and clinic exam|Baseline, Months 6, 12, 24|||Participants with Fundus Findings|||Number
841895|NCT01884597|Secondary|PCV Anatomic Changes|"Decrease and/or resolution in the branching vascular network of the PCV complex as measured by mean size of the branched vascular network (BVN) on ICG and fluorescein angiography
Decrease and/or resolution of the polyps of the PCV complex as measured on ICG and fluorescein angiography"|Baseline, Months 6, 12, 24|||Participants with PCV Anatomic Changes|||Number
841896|NCT01884597|Secondary|Macular Edema|Optical Coherence Tomography (OCT) central macular and peripapillary thickness|Baseline, Day 14, Month 1-24|Patient in Cohort 2 missed several visits.||microns||Standard Deviation|Mean
841897|NCT01884597|Secondary|BCVA|Best corrected visual acuity (BCVA), as assessed by the number of letters read correctly on the ETDRS eye chart at a starting test distance of 4 meters, at Baseline, Day 14, Month 1, Month 3, Month 6, Month 9 , Month 12, Month 15, Month 18, Month 21 and Month 24|at Baseline, Day 14, Month 1, Month 3, Month 6, Month 9 , Month 12, Month 15, Month 18, Month 21 and Month 24|||number of letters read correctly||Standard Deviation|Mean
841898|NCT01884597|Secondary|Systemic AEs|Incidence and severity of other adverse events, as identified by physical examination, subject reporting, and changes in vital signs|Monthly|||Number of Participants with Systemic AEs|||Number
841899|NCT01884597|Secondary|Ocular Adverse Events (AE)|Incidence and severity of ocular adverse events, as identified by eye examination (including visual acuity testing)|Monthly|||Ocular adverse events|||Number
841900|NCT01884597|Primary|BCVA|Mean change in best corrected visual acuity (BCVA), as assessed by the number of letters read correctly on the ETDRS eye chart at a starting test distance of 4 meters from Baseline to Month 24|Baseline to M24|||number of letters read correctly||Standard Deviation|Mean
841901|NCT01884597|Primary|BCVA|Mean change in best corrected visual acuity (BCVA), as assessed by the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart at a starting test distance of 4 meters from Baseline to Month 12.|From Baseline to Month 12|||number of letters read correctly||Standard Deviation|Mean
841902|NCT01811316|Other Pre-specified|Change From Baseline in Inflammatory Markers in Gingival Crevicular|Gingival Crevicular Fluid (GCF) samples will be analyzed for inflammatory cytokines/chemokines and matrix metalloproteases using multiplexing ELISA.|15 days, 4, 12 and 24 weeks||||||
841903|NCT01811316|Secondary|Change From Baseline in Probing Depth (PD)|Periodontal pocket depth (PD) was determined with a periodontal probe at six sites per tooth rounded to the next lower whole mm.|4, 12 and 24 weeks|One subject was lost to follow up between 4 and 12 weeks.||mm||Standard Deviation|Mean
841904|NCT01811316|Secondary|Change From Baseline in Plaque Index (PI)|"Plaque Index of Turesky Modification of Quigley-Hein (Turesky, Gilmore et al. 1970) (PI) was scored on all natural teeth (except third molars) after disclosing with erythrosine solution. Scores Criteria:
0 No plaque
Separate flecks of plaque at the cervical margin of the tooth
A thin continuous band of plaque (up to one mm) at the cervical margin of the tooth
A band of plaque wider than one mm but covering less than one-third of the crown of the tooth
Plaque covering at least one-third but less than two-thirds of the crown of the tooth
Plaque covering two-thirds or more of the crown of the tooth"|4, 12 and 24 weeks|One subject was lost to follow up between 4 and 12 weeks.||units on a scale||Standard Deviation|Mean
841905|NCT01811316|Primary|Change From Baseline in Bleeding on Probing (BOP)|Bleeding on probing was assessed 30 seconds after probin. A dichotomous scoring system was used at six sites per tooth using one (1) and zero (0) for presence or absence, respectively. BOP (%) is a percentage of sites BOP.|4, 12 and 24 weeks|One subject was lost to follow up between 4 and 12 weeks.||percentage of sites BOP||Standard Deviation|Mean
841921|NCT01740297|Secondary|Phase 2: Time to Response|Time to confirmed response (TTR) was defined as the time from randomization to the date of the first confirmed CR or PR per modified irRC criteria. Participants who did not have a confirmed CR or PR were censored at their last evaluable tumor assessment date.|Tumor response was assessed every 12 weeks until disease progression; median follow-up time was 57.7 weeks and 68.1 weeks in each treatment group respectively.|All participants randomized in phase 2||months||95% Confidence Interval|Median
841906|NCT01811316|Primary|Change From Baseline in Modified Gingival Index (MGI)|"Modified Gingival Index (MGI) (Lobene, Weatherford et al. 1986) was measured on six gingival areas of all scorable teeth, using a scale of 0-4 as follows: Scores Criteria 0 Normal (absence of inflammation)
Mild inflammation (slight change of color, little change in texture) of any portion of, but not the entire marginal or papillary gingival unit
Mild inflammation of the entire gingival unit
Moderate inflammation (moderate glazing, redness, edema and/or hypertrophy) of the marginal or papillary gingival unit
Severe inflammation (marked redness and edema/hyper-trophy, spontaneous bleeding or ulceration) of the marginal or papillary gingival unit.
Whole mouth MGI scores were calculated by summing all scores and dividing by the number of examined scorable sites."|4, 12 and 24 weeks|One subject was lost to follow up between 4 and 12 weeks.||units on a scale||Standard Deviation|Mean
841912|NCT01767506|Secondary|The Mean of the Prevalence of Active Trachoma (TF) in Communities in Both Arms.|"Model the risk of active trachoma in intervention and control communities. We used the mean % and 95 % confidence interval as they present for a variable to describe the center of the population the sample represents and the precision of the estimate of that center.
If the variable is normally distributed in the population, the probability is 95% that the true mean falls in the 95% confidence interval."|Baseline only|The trial was conducted at the community level||community|community|95% Confidence Interval|Mean
841913|NCT01767506|Secondary|The Proportion of Communities With Clinical Trachoma Prevalence of 5% or Below||24 months|The trial was conducted at the community level||community|community||Count of Units
841914|NCT01767506|Primary|The Proportion of Communities With C. Trachomatis Infection Prevalence of 1% or Below|The proportion of communities with C. trachomatis infection prevalence at 1% or below in children ages 1 to 9 years at the 24-month survey, comparing the intervention arm to the usual practice arm|24 months|The trial was conducted at the community level||community|community||Count of Units
841915|NCT01740297|Secondary|Number of Participants With Adverse Events|"Adverse events (AEs) were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, where grade 1 = mild AE, grade 2 = moderate AE, grade 3 = severe AE, grade 4 = life-threatening or disabling AE and grade 5 = death related to AE.
The investigator assessed whether each AE was possibly related to talimogene laherparepvec (T-VEC) and/or ipilimumab (Imab).
Note that one participant in the Phase 2 Ipilimumab Alone group was incorrectly noted as having an AE leading to discontinuation of T-VEC which was discovered and corrected after this analysis was conducted."|From first dose of study treatment until 30 days after the last dose; median duration of treatment was 14.7, 9.1, and 21.1 weeks in each treatment group respectively.|All participants who received ≥ 1 dose of investigational product (talimogene laherparepvec or ipilimumab).||participants|||Number
841916|NCT01740297|Secondary|Phase 2: Kaplan-Meier Estimate of Percentage of Participants Alive at Month 12 and 24|The overall survival estimates at month 24 data were not mature as most participants had not been followed for 24 months at the time of data cutoff.|Months 12 and 24; The median (Q1, Q3) follow-up time from randomization to the data cutoff date for the analysis was 80.6 (58.3, 106.3) weeks.|All participants randomized in phase 2||percentage of participants||95% Confidence Interval|Number
841917|NCT01740297|Secondary|Phase 2: Overall Survival|Overall survival was defined as the time from the date of randomization to the date of death from any cause. Participants without an event were censored at the last date they were known to be alive. Participants with a vital status obtained after the data cut-off were censored at the date cut-off date.|From randomization until the data cut-off date of 23 August 2016; median follow-up time was 57.7 weeks and 68.1 weeks in each treatment group respectively.|All participants randomized in phase 2||months||95% Confidence Interval|Median
841918|NCT01740297|Secondary|Phase 2: Resection Rate|Resection rate was defined as the percentage of participants who had surgical procedures for melanoma that resulted in a partial reduction or complete eradication of all previously unresectable cutaneous or visceral metastatic disease. Surgical procedures for melanoma with palliative intent (eg, for pain control) in the presence of disease progression were not considered resection.|From randomization until the data cut-off date of 23 August 2016; median follow-up time was 57.7 weeks and 68.1 weeks in each treatment group respectively.|All participants randomized in phase 2||percentage of participants||95% Confidence Interval|Number
841919|NCT01740297|Secondary|Phase 2: Progression-free Survival|Progression-free survival was measured from the date of randomization to the date of disease progression (as measured by modified irRC) or death on or before the data cutoff date, whichever occurred first. Participants who had no disease progression and did not die while on study were censored at the last disease assessment date.|From randomization until the data cut-off date of 23 August 2016; median follow-up time was 57.7 weeks and 68.1 weeks in each treatment group respectively.|All participants randomized in phase 2||months||95% Confidence Interval|Median
841920|NCT01740297|Secondary|Phase 2: Duration of Response|Duration of response was calculated only for participants with an objective response per modified irRC and was defined as the time from first confirmed objective response (CR or PR) to confirmed disease progression per the modified irRC or death, whichever was earlier. Responders who did not have an event of death or disease progression were censored at their last evaluable tumor assessment date.|Tumor response was assessed every 12 weeks until disease progression; median follow-up time was 57.7 weeks and 68.1 weeks in each treatment group respectively.|Participants randomized in phase 2 with a confirmed CR or PR.||months||95% Confidence Interval|Median
841922|NCT01740297|Secondary|Phase 2: Durable Response Rate|Durable response rate (DRR) was defined as the percentage of participants with a duration of response (best response of CR or PR) per modified irRC of at least 6 months. Duration of response is the time from the first confirmed CR or PR to confirmed disease progression per the modified irRC or death, whichever occurs earlier.|Tumor response was assessed every 12 weeks until disease progression; median follow-up time was 57.7 weeks and 68.1 weeks in each treatment group respectively.|All participants randomized in phase 2||percentage of participants||95% Confidence Interval|Number
841923|NCT01740297|Secondary|Phase 2: Disease Control Rate|"Disease control rate (DCR) was defined as the percentage of participants with a best overall response of CR, PR or SD based on investigator assessment according to the modified irRC.
CR: Complete disappearance of all lesions and no new lesions; any pathological lymph nodes reduced in short axis to <10 mm.
PR: Decrease in tumor burden ≥ 50% relative to baseline. SD: Not meeting criteria for CR or PR, in absence of PD and no earlier than 77 days after the date of enrollment/randomization.
CR and PR must have been confirmed at 2 consecutive assessments ≥ 4 weeks apart."|Tumor response was assessed every 12 weeks until disease progression; median follow-up time was 57.7 weeks and 68.1 weeks in each treatment group respectively.|All participants randomized in phase 2||percentage of participants||95% Confidence Interval|Number
841924|NCT01740297|Secondary|Phase 2: Best Overall Response|"Best overall response was categorized in descending order as a complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD) or unevaluable (UE) based on investigator assessment according to the modified irRC.
CR: Complete disappearance of all lesions and no new lesions; Any pathological lymph nodes reduced in short axis to <10 mm.
PR: Decrease in tumor burden ≥ 50% relative to baseline. PD: Increase in tumor burden ≥ 25% relative to nadir. SD: Not meeting criteria for CR or PR, in absence of PD and no earlier than 77 days after the date of enrollment/randomization.
CR, PR and PD must have been confirmed at 2 consecutive assessment ≥ 4 weeks apart.
Assessments occurring after the start of the first subsequent anticancer therapy or removal of a lesion were not included."|Tumor response was assessed every 12 weeks until disease progression; median follow-up time was 57.7 weeks and 68.1 weeks in each treatment group respectively.|All participants randomized in phase 2||participants|||Number
841925|NCT01740297|Secondary|Phase 1b: Objective Response Rate|"Objective response rate is defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) according to the modified immune-related response criteria (irRC) assessed by the investigator. Tumors were examined clinically and by computed tomography (CT) or magnetic resonance imaging (MRI).
CR: Complete disappearance of all lesions and no new lesions; Any pathological lymph nodes reduced in short axis to <10 mm.
PR: Decrease in tumor burden ≥ 50% relative to baseline. Response must have been confirmed by a repeat, consecutive assessment ≥ 4 weeks from the date first documented. Participants who did not have any follow-up tumor assessments were regarded as non-responders."|Tumor response was assesed every 12 weeks until disease progression; median follow-up time was 148.4 weeks.|All phase 1b participants who received ≥ 1 dose of investigational product (talimogene laherparepvec or ipilimumab).||percentage of participants||95% Confidence Interval|Number
841926|NCT01740297|Primary|Phase 2: Objective Response Rate|"Objective response rate is defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) according to the modified immune-related response criteria (irRC) assessed by the investigator. Tumors were examined clinically and by computed tomography (CT) or magnetic resonance imaging (MRI).
CR: Complete disappearance of all lesions and no new lesions; Any pathological lymph nodes reduced in short axis to <10 mm.
PR: Decrease in tumor burden ≥ 50% relative to baseline. Response must have been confirmed by a repeat, consecutive assessment ≥ 4 weeks from the date first documented. Participants who did not have any follow-up tumor assessments were regarded as non-responders."|Tumor response was assessed every 12 weeks until disease progression; median follow-up time was 57.7 weeks and 68.1 weeks in each treatment group respectively.|All participants randomized in phase 2||percentage of participants||95% Confidence Interval|Number
841927|NCT01740297|Primary|Phase 1b: Number of Participants With Dose-limiting Toxicities|"A DLT was defined as any toxicity related to study drug which met any of the following criteria based on Common Terminology Criteria for Adverse Events version 3.0:
treatment-related non-laboratory adverse events (AE) ≥ grade 4
≥ grade 4 immune-mediated dermatitis
≥ grade 4 immune-mediated endocrinopathy (except autoimmune thyroiditis)
≥ grade 3 immune-mediated enterocolitis
≥ grade 3 immune-mediated hepatitis (except grade 3 that resolved to grade 1 or baseline within 28 days of onset)
≥ grade 3 immune-mediated neuropathy
≥ grade 3 other immune-mediated AEs including hemolytic anemia, angiopathy, myocarditis, pericarditis, temporal arteritis, or vasculitis, autoimmune thyroiditis (except grade 3 that resolved to grade 1 or baseline within 28 days of onset), blepharitis, conjunctivitis, episcleritis, iritis, scleritis, or uveitis, pancreatitis, meningitis, arthritis or polymyalgia rheumatic, nephritis, pneumonitis, psoriasis or leukocytoclastic vasculitis."|The DLT evaluation period was 6 weeks from the initial administration of ipilimumab (week 6 to 12).|All phase 1b participants who received ≥ 1 dose of investigational product (talimogene laherparepvec or ipilimumab).||participants|||Number
841928|NCT01717209|Secondary|Heart Rate|Heart Rate was measured as mean of Heart Rate for the initial 8 hours after admission to the Intensive Care Unit (ICU). Normal range for heart rate is generally 60 to 100 beats per minutes in adults, but this can vary.|8 hours (upon arrival at ICU, and after 4 successive 2 hour treatments with 1. iNO only, 2. iNO+iPGI2 (1st), 3. iPGI2 only, and 4. iNO+iPGI2 (2nd))|||beats/minute||Full Range|Mean
841929|NCT01717209|Secondary|Mean Arterial Pressure (MAP)|Mean Arterial Pressure (MAP) was measured as mean of MAP for the initial 8 hours after admission to the Intensive Care Unit (ICU). Normal range for MAP is 70-110 mmHg.|8 hours (upon arrival at ICU, and after 4 successive 2 hour treatments with 1. iNO only, 2. iNO+iPGI2 (1st), 3. iPGI2 only, and 4. iNO+iPGI2 (2nd))|||mmHg||Full Range|Mean
841930|NCT01717209|Secondary|Central Venous Pressure (CVP)|Central Venous Pressure (CVP) was measured as mean of CVP for the initial 8 hours after admission to the Intensive Care Unit (ICU). Normal range for CVP is 3-8 mmHg.|8 hours (upon arrival at ICU, and after 4 successive 2 hour treatments with 1. iNO only, 2. iNO+iPGI2 (1st), 3. iPGI2 only, and 4. iNO+iPGI2 (2nd))|||mmHg||Full Range|Mean
841931|NCT01717209|Secondary|Systemic Vascular Resistance (SVR)|Systemic Vascular Resistance (SVR) was measured as mean of Systemic Vascular Resistance (SVR) for the initial 8 hours after admission to the Intensive Care Unit (ICU). Normal range for SVR is 800-1200 dynes/sec/cm5.|8 hours (upon arrival at ICU, and after 4 successive 2 hour treatments with 1. iNO only, 2. iNO+iPGI2 (1st), 3. iPGI2 only, and 4. iNO+iPGI2 (2nd))|||dynes/sec/cm^5||Full Range|Mean
841932|NCT01717209|Secondary|Right Heart Dysfunction|Right Heart Dysfunction was measured as mean of Right Ventricular Stroke Work Index (RVSWI) for the initial 8 hours after admission to the Intensive Care Unit (ICU). RVSWI is measured as the difference in mean pulmonary artery pressure (MPAP) and central venous pressure (CVP), divided by the cardiac index (CI): [(MPAP-CVP) / CI]. Normal range for RVSWI is 5-10 g/m.|8 hours (upon arrival at ICU, and after 4 successive 2 hour treatments with 1. iNO only, 2. iNO+iPGI2 (1st), 3. iPGI2 only, and 4. iNO+iPGI2 (2nd))|||g/m||Full Range|Mean
841933|NCT01717209|Primary|Pulmonary Hypertension|Pulmonary hypertension was measured as mean of Mean Pulmonary Artery Pressure for initial 8 hours after admission to the Intensive Care Unit (ICU). MPAP value ≥25 mmHg (resting) indicates pulmonary hypertension state.|8 hours (upon arrival at ICU, and after 4 successive 2 hour treatments with 1. iNO only, 2. iNO+iPGI2 (1st), 3. iPGI2 only, and 4. iNO+iPGI2 (2nd))|||mmHg||Full Range|Mean
841936|NCT01693653|Secondary|Safety|The study was terminated. No data were collected for this outcome measure.|9 moths||||||
841937|NCT01693653|Secondary|BDCAF|The study was terminated. No data were collected for this outcome measure.|9 months||||||
841938|NCT01693653|Secondary|MDHAQ|The study was terminated. No data were collected for this outcome measure.|9 months||||||
841939|NCT01693653|Secondary|BSAS|The study was terminated. No data were collected for this outcome measure.|9 months||||||
841940|NCT01693653|Secondary|Gential Ulcer Pain|The study was terminated. No data were collected for this outcome measure.|9 months||||||
841941|NCT01693653|Secondary|Oral Ulcer Pain|The study was terminated. No data were collected for this outcome measure.|9 months||||||
841942|NCT01693653|Secondary|Treatment Failures|The study was terminated. No data were collected for this outcome measure.|9 months||||||
841943|NCT01693653|Secondary|Oral Ulcers|The study was terminated. No data were collected for this outcome measure.|9 months||||||
841944|NCT01693653|Secondary|Genital Ulcers|The study was terminated. No data were collected for this outcome measure.|9 months||||||
841945|NCT01693653|Primary|Primary Outcome|The study was terminated. No data were collected for this Outcome Measure.|9 months|The study was terminated. No data were collected for this Outcome Measure.|||||
841946|NCT01688102|Other Pre-specified|Gene Expression Changes in Skin|Interferon response genesets (curated by GSEA)|baseline vs. 2 months|||GSEA Normalized Enrichment Score|||Number
841947|NCT01688102|Other Pre-specified|Gene Expression Changes in Peripheral Blood|Interferon response genesets (curated by GSEA)|baseline vs. 2 months|||GSEA Normalized Enrichment Score|||Number
841948|NCT01688102|Other Pre-specified|Correlation Between Change in LDL Cholesterol and Change in PTH||2 months|||Pearson correlation coefficient|||Number
841949|NCT01688102|Other Pre-specified|Correlation Between Change in LDL Cholesterol and Change in Calcium|The Correlation between change in LDL cholesterol and change in serum calcium|2 months|||Pearson correlation coefficient|||Number
841950|NCT01688102|Secondary|Change in Parathyroid Hormone (PTH)||baseline vs.6 months|||pg/mL||Standard Deviation|Mean
841951|NCT01688102|Secondary|Change in Serum Calcium||baseline vs. 6 months|||mg/dL||Standard Deviation|Mean
841952|NCT01688102|Secondary|Change in 25(OH)D||baseline vs. 6 months|Data only for those who completed 6 months of therapy||ng/ml||Standard Deviation|Mean
841953|NCT01688102|Secondary|Change in C Reactive Protein||baseline and 6 months|Data analyzed are only for those who completed 6 months of therapy||mg/L||Standard Deviation|Mean
841954|NCT01688102|Secondary|Change in Triglycerides||baseline 6 months or last observation carried forward (minimum 2 months)|||mg/dL||Standard Deviation|Mean
841955|NCT01688102|Secondary|Change in HDL Cholesterol||baseline and 6 months or last observation carried forward (minimum 2 months)|||mg/dL||Standard Deviation|Mean
841956|NCT01688102|Secondary|Change in Total Cholesterol|Change in Total Cholesterol|baseline and 6 months or last observation carried forward (minimum 2 months)|||mg/dL||Standard Deviation|Mean
841957|NCT01688102|Primary|Change in LDL Cholesterol Level||baseline and 6 months or last observation carried forward (minimum 2 months)|||mg/dl||Standard Deviation|Mean
842389|NCT02681510|Primary|Number of Participants With Adverse Events|Assess adverse event rates in relation to participant ability to continue use of all 3 medications throughout the treatment period|12 weeks|All study participants (N=36)||Participants|||Count of Participants
841983|NCT01682044|Secondary|Percent Change in Serum Levels of Free Radical Levels (MFI) From Baseline|Mean percent change in MFI level from baseline.|Baseline and weeks 1, 3, 5, 7, 15, 23, 31, and 39|All treated and eligible patients||percent change||Standard Deviation|Mean
841984|NCT01682044|Secondary|Percent Change in Serum Levels of Interferon Alpha (INF) From Baseline|Mean percent change in INF level from baseline.|Baseline and weeks 1, 3, 5, 7, 15, 23, 31, and 39|All treated and eligible patients||percent change||Standard Deviation|Mean
841985|NCT01682044|Secondary|Percent Change in Serum Levels of Tumor Necrosis Factor (TNF) From Baseline|Mean percent change in TNF level from baseline at each visit.|Baseline and weeks 1, 3, 5, 7, 15, 23, 31, and 39|All treated and eligible patients||percent change||Standard Deviation|Mean
841986|NCT01682044|Secondary|Percent Change in CD20 Antigen Expression and Density of Expression|Percent change in CD20 antigen expression and density of expression|At 4 years|Samples tissues were not large enough to perform analysis. No participants were analyze.|||||
841987|NCT01682044|Secondary|Percent Change in Functional and Phenotypic Characteristics of Host Neutrophils From Baseline|Mean percent change in CD11b level from baseline at each visit|Baseline and weeks 1, 3, 5, 7, 15, 23, 31, and 39|All treated and eligible patients||percent change||Standard Deviation|Mean
841988|NCT01682044|Secondary|Overall Response Rate|Overall Response is defined as Complete Response: During observation, no disease is apparent, including measurable and non-measurable disease, and no evidence of disease is observed for at least 28 days, as confirmed by a second assessment following the original observation of no disease; and Partial Response: A 50% or greater decrease from baseline in the sum of the products of the longest perpendicular diameters of all the measured lesions is noted for at least 28 days as confirmed by a second assessment following the observation of the 50% or greater decrease, and no appearance of new lesions is noted.|Up to 43 weeks|All treated and eligible patients||percentage of participants||95% Confidence Interval|Number
841989|NCT01682044|Primary|Number of Participants With Adverse Events|Frequency of Adverse Events, Graded According to NCI CTCAE v3.0. Grade 1: Mild AE; Grade 2: Moderate AE; Grade 3: Severe AE; Grade 4: Life-threatening or disabling AE; Grade 5: Death related to AE|Up to 90 days after the last dose of study drugs|All treated and eligible patients||Participants|||Count of Participants
842004|NCT01646177|Secondary|Number of Participants With Treatment-Emergent Anti-Ixekizumab Antibodies|The percentage of participants with treatment-emergent positive anti-ixekizumab antibodies at any time post-baseline were summarized by treatment group. Percentage of participants with treatment-emergent positive anti-ixekizumab antibodies were calculated as: number of participants with an evaluable baseline sample and ≥1 evaluable post-baseline sample/number of participants in the analysis population * 100.|Baseline, Week 12|All randomized participants who received at least one dose of study treatment and had evaluable data.||Participants|||Number
842005|NCT01646177|Secondary|Number of Participants Achieving Palmoplantar PASI of 100% (PPASI 100) Improvement|Palmoplantar PASI is a composite score derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement, ranging from 0 to 72. Participants achieving PPASI 100 were defined as having an improvement of 100% in the PPASI scores compared to baseline.|Week 12|All randomized participants, even if the participant did not take the assigned treatment, or did not follow the protocol, and had a diagnosis of palmoplantar psoriasis at baseline. Participants who did not meet clinical response criteria or have missing data at Week 12 will be considered non-responders for the NRI analysis.||Participants|||Number
842006|NCT01646177|Secondary|Number of Participants Achieving Palmoplantar PASI of ≥75% (PPASI 75) Improvement|Palmoplantar PASI is a composite score derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement, ranging from 0 to 72. Participants achieving PPASI 75 were defined as having an improvement of at least 75% in the PPASI scores compared to baseline.|Week 12|All randomized participants, even if the participant did not take the assigned treatment, or did not follow the protocol, and had a diagnosis of palmoplantar psoriasis at baseline. Participants who did not meet clinical response criteria or have missing data at Week 12 will be considered non-responders for the NRI analysis.||Participants|||Number
842007|NCT01646177|Secondary|Number of Participants Achieving Palmoplantar PASI of ≥50% (PPASI 50) Improvement|Palmoplantar PASI is a composite score derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement, ranging from 0 to 72. Participants achieving PPASI 50 were defined as having an improvement of at least 50% in the PPASI scores compared to baseline.|Week 12|All randomized participants, even if the participant did not take the assigned treatment, or did not follow the protocol, and had a diagnosis of palmoplantar psoriasis at baseline. Participants who did not meet clinical response criteria or have missing data at Week 12 will be considered non-responders for the NRI analysis.||Participants|||Number
842008|NCT01646177|Secondary|Change From Baseline in Patient's Global Assessment of Disease Severity|"The Patient's Global Assessment of Disease Severity is a single-item participant-reported outcome measure on which participants are asked to rate the severity of their psoriasis today from 0 (Clear) = no psoriasis, to 5 (Severe) = the worst their psoriasis has ever been. LS Means in Patient's Global Assessment of Disease Severity score were calculated using MMRM with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects."|Baseline, Week 12|All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol, and had at least one post-dose measurement of Patient's Global Assessment of Disease Severity.||Units on a Scale||Standard Error|Least Squares Mean
842009|NCT01646177|Secondary|Change From Baseline in Medical Outcomes Study 36-Item Short Form (SF-36) Health Survey, Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores|The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped into the PCS and MCS scores. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. In this study, the SF-36 acute version was used, which has a 1 week recall period. LS Means in SF-36 score were calculated using the ANCOVA model with treatment, pooled center and baseline SF-36 score.|Baseline, Week 12|All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol, and had at least one post-dose measurement of SF-36. Participants with missing SF-36 data were imputed by Last Observation Carried Forward (LOCF) method.||Units on a Scale||Standard Error|Least Squares Mean
842010|NCT01646177|Secondary|Change From Baseline in All Scores of the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO)|The WPAI-PSO is a 6-item instrument used to assess the impact of psoriasis on productivity impairment within the past 7 days. It has four domains: absenteeism, presenteeism (reduced productivity while at work), an overall work impairment score, and impairment in daily activities performed outside of work. Four scores are derived as percentages: absenteeism, presenteeism, overall work impairment (absenteeism and presenteeism), and impairment in activities performed outside of work. Percentage is calculated as: each score * 100 and ranged from 0 to 100. Higher scores indicate greater impairment in productivity. LS Means in each WPAI-PSO score were calculated using the ANCOVA model with treatment, pooled center and baseline WPAI-PSO score.|Baseline, Week 12|All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol, and had at least one post-dose measurement of WPAI-PSO. Participants with missing WPAI-PSO data were imputed by Last Observation Carried Forward (LOCF) method.||Units on a Scale||Standard Error|Least Squares Mean
842011|NCT01646177|Secondary|Change From Baseline in Quick Inventory of Depressive Symptomatology-Self Report 16 Items (QIDS-SR16) Total Score [Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO)]|The QIDS-SR16 is a self-administered, 16-item instrument in which a participant is asked to consider each statement as it relates to the way they have felt for the past 7 days. There is a 4-point scale for each item ranging from 0 (best) to 3 (worst). The 16 items are scored to give 9 individual depression domains (sad mood, concentration, self-criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance [initial, middle and late insomnia or hypersomnia], decrease/increase in appetite/weight, and psychomotor agitation/retardation), which are summed to give a single score ranging from 0 to 27, with higher scores denoting greater symptom severity. LS Means in total QIDS-SR16 score were calculated using the analysis of covariance (ANCOVA) model with treatment, pooled center and baseline QIDS total score.|Baseline, Week 12|All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol, and had at least one post-dose measurement of QIDS-SR16. Participants with missing QIDS-SR16 data were imputed by Last Observation Carried Forward (LOCF) method.||Units on a Scale||Standard Error|Least Squares Mean
842012|NCT01646177|Secondary|Change From Baseline in Psoriasis Scalp Severity Index (PSSI) Score|PSSI is a composite score ranging from 0 (best) to 72 (worst), derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of scalp area involved. LS Means in PSSI score were calculated using MMRM with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.|Baseline, Week 12|All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol, who had scalp psoriasis at baseline and had at least one post-dose measurement of PSSI.||Units on a Scale||Standard Error|Least Squares Mean
842013|NCT01646177|Secondary|Percent of Body Surface Area (BSA) Involvement of Psoriasis|Percentage involvement of psoriasis on each participants body surface area was assessed by the investigator on a continuous scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participant's hand (including palm, fingers and thumb). LS Means in BSA were calculated using MMRM with baseline BSA as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.|Week 12|All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol, and had at least one post-dose measurement of BSA.||Percent||Standard Error|Least Squares Mean
842014|NCT01646177|Secondary|Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score|The NAPSI is a numeric, reproducible, objective tool used to evaluate the severity of fingernail bed psoriasis and fingernail matrix psoriasis by area of involvement in the fingernail unit. The fingernail is divided with imaginary horizontal and longitudinal lines into quadrants. Each fingernail is given a score for fingernail bed psoriasis: 0 (none) to 4 (psoriasis in 4 quadrants of the nail) and fingernail matrix psoriasis (0 to 4) depending on the presence (score of 1) or absence (score of 0) of any of the features of fingernail bed and fingernail matrix psoriasis in each quadrant. The NAPSI score of a fingernail is the sum of scores in fingernail bed and fingernail matrix from each quadrant (maximum of 8). Each fingernail is evaluated, and the sum of all the fingernails is the total NAPSI score (range, 0 to 80). LS Means in NAPSI score were calculated using MMRM with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.|Baseline, Week 12|All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol, who had fingernail involvement at baseline and had at least one post-dose measurement of NAPSI.||Units on a Scale||Standard Error|Least Squares Mean
842015|NCT01646177|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score|The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include “not at all,” “a lot,” and “very much,” with corresponding scores of 1, 2, and 3, respectively, and unanswered (“not relevant”) responses scored as “0.” Totals range from 0 to 30 (less to more impairment), and a 5 point change from baseline is considered clinically relevant. Least Square (LS) Means in total DLQI score were calculated using Mixed Model Repeated Measures (MMRM) with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.|Baseline, Week 12|All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol, and had at least one post-dose measurement of DLQI.||Units on a Scale||Standard Error|Least Squares Mean
842016|NCT01646177|Secondary|Number of Participants Achieving an Itch Numeric Rating Scale (NRS) ≥4 Point Reduction [Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO)]|The Itch NRS is a participant-administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing “no itch” and 10 representing “worst itch imaginable.” Participants indicate their overall severity of itching from Psoriasis by circling the number that best describes the worst level of itching in the past 24 hours.|Baseline, Week 12|All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or did not follow the protocol, and had an Itch NRS score >=4 at baseline. Participants who did not meet clinical response criteria or have missing data at Week 12 will be considered non-responders for the NRI analysis.||Participants|||Number
842017|NCT01646177|Secondary|Number of Participants Achieving 100% (PASI 100) Improvement (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: PASI)|The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 100 were defined as having an improvement of at least 100% in the PASI scores compared to baseline.|Week 12|All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Participants who did not meet clinical response criteria or have missing data at Week 12 will be considered non-responders for the Non-Responder Imputation (NRI) analysis.||Participants|||Number
842018|NCT01646177|Secondary|Number of Participants Achieving ≥90% (PASI 90) Improvement (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: PASI)|The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 90 were defined as having an improvement of at least 90% in the PASI scores compared to baseline.|Week 12|All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Participants who did not meet clinical response criteria or have missing data at Week 12 will be considered non-responders for the Non-Responder Imputation (NRI) analysis.||Participants|||Number
842019|NCT01646177|Secondary|Number of Participants Achieving an sPGA (0) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: sPGA)|The sPGA is a physician’s determination of the participant’s psoriasis lesions overall at a given time point categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant’s psoriasis is assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA (0) response was defined as a post-baseline sPGA score of 0.|Week 12|All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Participants who did not meet clinical response criteria or have missing data at Week 12 will be considered non-responders for the Non-Responder Imputation (NRI) analysis.||Participants|||Number
842020|NCT01646177|Primary|Number of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: PASI)|The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 75 was defined as having an improvement of at least 75% in the PASI scores compared to baseline.|Week 12|All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Participants who did not meet clinical response criteria or have missing data at Week 12 will be considered non-responders for the Non-Responder Imputation (NRI) analysis.||Participants|||Number
842021|NCT01646177|Primary|Number of Participants Achieving a Static Physician Global Assessment (sPGA) of (0, 1) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: sPGA)|The sPGA is a physician’s determination of the participant’s psoriasis lesions overall at a given time point categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant’s psoriasis is assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA (0,1) response was defined as a post-baseline sPGA score of 0 or 1.|Week 12|All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Participants who did not meet clinical response criteria or have missing data at Week 12 will be considered non-responders for the Non-Responder Imputation (NRI) analysis.||Participants|||Number
842238|NCT00878709|Primary|Kaplan-Meier Estimates of Invasive Disease-free Survival (iDFS) at Year 2 by Treatment Arms||From randomization until time of event up to 2 years|Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment.||percentage of participants||95% Confidence Interval|Number
842057|NCT01576055|Secondary|Number of Participants With Device Success|Successful delivery of stent to the intended site and successful stent deployment.|Immediately following initial device implant (usually within a few minutes to an hour).|Per Protocol Population||participants|||Number
842058|NCT01576055|Secondary|Number of Participants With Procedural Success|Successful device implantation with a residual stenosis <30% without acute (within 48 hours) serious adverse events.|Within 48 hours of initial device implant|Per Protocol Population||participants|||Number
842059|NCT01576055|Primary|Primary Efficacy Endpoint - Number of Participants With Primary Patency at 12 Months|Primary patency is defined by a Peak Systolic Velocity Ratio (PSVR) ≤2.5 without target lesion revascularization (TLR) at 12 months after implantation.|12 Months|Per Protocol Population (Participants Available for 12-Month Follow-Up)||participants|||Number
842060|NCT01576055|Primary|Primary Safety Endpoint - Number of Participants Free From Major Adverse Events at 30 Days|Defined as any adverse event (occurring within 30 days of the initial procedure) that causes death, target vessel revascularization (TVR), and amputation above the metatarsals in the treated leg (index limb amputation).|30 Days|Per Protocol Population (Participants Available for 30-Day Follow-Up)||participants|||Number
842068|NCT01465997|Primary|Number of Subjects With at Least One Treatment-emergent Serious Adverse Event (SAE) During the Treatment Phase (Maximum of 3.5 Years)|A Serious Adverse Event is any untoward medical occurrence that at any dose results in death, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity is a congenital anomaly/birth defect.|Up to 3.5 Years (Duration of the Treatment Phase)|||Participants|||Count of Participants
842069|NCT01465997|Primary|Number of Subjects Who Withdrew From the Study Due to a Treatment-emergent Adverse Event (AE) During the Treatment Phase (Maximum 3.5 Years)|Treatment-emergent AEs were defined as those events which started on or after the date of first dose of SP0994 study medication, or events in which severity worsened on or after the date of first dose of SP0994 study medication. AEs which occurred within 30 days after last dose of study medication were considered treatment emergent.|Up to 3.5 Years (Duration of the Treatment Phase)|||Participants|||Count of Participants
842070|NCT01465997|Primary|Number of Subjects With at Least One Treatment-emergent Adverse Event (AE) During the Treatment Phase (Maximum of 3.5 Years)|Treatment-emergent AEs were defined as those events which started on or after the date of first dose of SP0994 study medication, or events in which severity worsened on or after the date of first dose of SP0994 study medication. AEs which occurred within 30 days after last dose of study medication were considered treatment emergent.|Up to 3.5 Years (Duration of the Treatment Phase)|||Participants|||Count of Participants
842071|NCT01463527|Secondary|Frequency of Hypoxia Defined as Pulse Oximetry Less Than 95%.||Every 30 seconds during sedation; this is on average 30 minutes (range 10-240 minutes)||||||
842072|NCT01463527|Primary|Frequency of Staff Interventions for Hypoventilation.|These include verbal or physical stimulation, administration of supplemental oxygen, bag-valve mask ventilation, or use invasive airway devices.|Every 30 seconds during sedation; this is on average 30 minutes (range 10-240 minutes)|||Events per patient minute of sedation||Full Range|Mean
842073|NCT01439165|Secondary|Percentage of Participants Reporting a Solicited Injection Site or Systemic Reactions|Injection site reactions: Pain, Erythema, and Swelling. Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3 Injection site reactions: Pain, Significant, prevents daily activity. Erythema and Swelling, >100 mm. Grade 3 Systemic reactions: Fever, ≥39°C or ≥102.1 F; Headache, Malaise, and Myalgia, Significant; prevents daily activity.|Day 0 up to Day 7 post-vaccination|Solicited injection site and systemic reactions were assessed in the Safety Analysis Set.||Percentage of participants|||Number
842074|NCT01439165|Primary|Percentage of Subjects With Pertussis Antigen Booster Response|"Anti-Pertussis antibodies (Pertussis toxoid, Filamentous Hemagglutinin [FHA], Pertactin, Fimbriae (types 2 and 3) were assessed using an enzyme-linked immunosorbent assay. Booster response is defined as a minimum rise in antibody concentration from pre- to post-vaccination. The minimum rise is at least 2 times if the pre-vaccination concentration is above the cutoff value, or at least 4 times if it is at or below the cutoff value.
Anti-pertussis toxoid booster response rates further to Adacel vaccination was compared to an expected booster rates based on study Td506 (PMID 15933223) since Td Adsorbed Vaccine does not contain any pertussis antigens."|1 month post-booster vaccination|Booster response rate was assessed in the Per protocol analysis set||Percentage of subjects|||Number
842075|NCT01439165|Primary|Geometric Mean Concentrations (GMC) of Anti Pertussis Antibodies|Anti-Pertussis antibodies (Pertussis toxoid, Filamentous Hemagglutinin (FHA), Pertactin, Fimbriae types 2 and 3) were assessed using an enzyme-linked immunosorbent assay. Anti-pertussis GMCs further to Adacel vaccination was compared to an historical control group with Daptacel (NCT00255047 for pertussis toxoid and PMID 8538705 for FHA, Pertactin and Fimbriae) since Td Adsorbed Vaccine does not contain any pertussis antigens.|1 month post-booster vaccination|Geometric mean concentrations were assessed in the Per Protocol Analysis Set.||Concentrations (1/dil)||95% Confidence Interval|Geometric Mean
842115|NCT01383928|Secondary|Phase 1: Tmax- Time to Reach the Maximum Plasma Concentration (Cmax) for Ixazomib|Tmax: Time to reach the first maximum plasma concentration (Cmax), equal to time (hours) to Cmax of ixazomib after administration, obtained directly from the plasma concentration-time curve.|Cycle 1, Days 1 and 11|PK analysis population included all participants, who had sufficient dosing data and ixazomib concentration-time data to permit calculation of PK parameters where Days 1 and 11 assessments were available.||hours||Full Range|Median
842076|NCT01439165|Primary|Percentage of Participants With Diphtheria and Tetanus Booster Response|Anti-Diphtheria antibodies were assessed by a toxin neutralization test. Anti-Tetanus antibodies were assessed using an enzyme-linked immunosorbent assay. A booster response was defined as a 4-fold increase in pre- to post-vaccination antibody concentrations for subjects with pre-vaccination antibody concentrations ≤2.56 IU/mL for diphtheria and ≤ 2.7 IU/mL for tetanus. If the pre vaccination antibody concentrations were > 2.56 IU/mL for diphtheria and > 2.7 IU/mL for tetanus, then a 2-fold increase in response rate was defined as a booster response.|1 month post-booster vaccination|Booster response rates were assessed in the Per Protocol Analysis Set.||Percentage of participants|||Number
842077|NCT01439165|Primary|Percentage of Participants With Diphtheria and Tetanus Seroprotection|Anti-Diphtheria antibodies were assessed by a toxin neutralization test. Anti-Tetanus antibodies were assessed using an enzyme-linked immunosorbent assay. Seroprotection was defined as the following: Anti-Diphtheria and Anti-Tetanus ≥ 0.1 IU/mL.|1 month post-booster vaccination|Seroprotection was assessed in the Per Protocol Analysis Set.||Percentage of participants|||Number
842078|NCT01390948|Secondary|Percentage of Participants With an Adverse Event (AE)|An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|From the time of randomization of the first participant to the date of clinical cutoff (approximately 52 months)|Safety population included all participants that received study drug.||percentage of participants|||Number
842079|NCT01390948|Secondary|Number of Dose Administrations of Study Treatment in the Concurrent Phase|Number of doses were assessed for the concurrent phase, which is the treatment period after the initial treatment phase and including the subsequent treatment break of approximately 4 weeks.|Beginning of the concurrent phase to end of treatment break (10 weeks)|Safety population included all participants that received study drug.||number of dose administrations||Full Range|Median
842080|NCT01390948|Secondary|Percentage of Participants With a Treatment Delay or Discontinuation||From the time of randomization of the first participant to the date of clinical cutoff (approximately 52 months)|Randomized participant population included all randomized participants regardless of whether they received study treatment.||percentage of participants|||Number
842081|NCT01390948|Secondary|Percentage of Participants Who Completed >/= 90% of Planned Radiotherapy and TMZ Administrations||From the time of randomization of the first participant to the date of clinical cutoff (approximately 52 months)|Safety population included all participants that received study treatment.||percentage of participants|||Number
842082|NCT01390948|Secondary|Neurological Psychological Function as Measured by the Wechsler Scale|The Wechsler Intelligence Scale for Children version IV (WISC-IV) was used to generate a full scale intelligence quotient (IQ) which represents a child's general intellectual ability. The average IQ score is 100, with lower scores representing lower intellectual ability.|End of treatment (approximately 58 weeks post-baseline)|Randomized participant population included all randomized participants regardless of whether they received study treatment.||units on a scale||Standard Deviation|Mean
842083|NCT01390948|Secondary|Health Status as Measured by the Health Utility Index (HUI)|HUI is a preference-based, multi-attitude, health-related instrument specifically developed for use with children. HUI consists of eight attributes of health status: vision, hearing, speech, ambulation, dexterity, emotion, cognition and pain. Each attribute had 5 or 6 levels varying from highly impaired to normal. Each of the eight health dimensions was tested separately and a composite score ranging between 1 (perfect health) and 0 (death) was obtained for participants aged 5 years or older.|Baseline, Cycle 6 of the adjuvant phase, end of treatment (approximately 58 weeks post-baseline), and yearly during the follow-up period (maximum 5 years in follow-up)|Randomized participant population aged 5 years or older with a measure at the specified time point. Here, 'n' represents the number of participants with a measure at the specified time point.||units on a scale||Standard Deviation|Mean
842084|NCT01390948|Secondary|Concordance Between Structural Versus Multimodal Imaging for CRRC-Assessed Event-Free Survival|Concordance is presented as the percentage of participants with concordance between assessments. EFS concordance was defined as event Structural assessment and Diffusion Perfusion assessment occurs within 28 days or no event Structural and no Diffusion Perfusion.|From the time of randomization of the first participant to the date of clinical cutoff (approximately 52 months)|Randomized participant population included all randomized participants regardless of whether they received study treatment.||percentage of participants|||Number
842085|NCT01390948|Secondary|Objective Response Rate (ORR)|ORR was defined as the percentage of participants with a complete response (CR) or partial response (PR) determined on two consecutive occasions >/= 4 weeks apart. Tumor assessments were conducted using MRI and reviewed by the site-independent CRRC using RANO criteria. The following were needed to qualify as CR: complete disappearance of all measurable enhancing lesions sustained for at least 4 weeks by MRI, no steroids above physiological levels, clinical status stable or improved compared to baseline. The following were needed to qualify as PR: ≥ 50% decrease from baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions sustained for at least 4 weeks by MRI, steroid dose not increased compared to baseline, clinical status stable or improved compared to baseline.|From the time of randomization of the first participant to the date of clinical cutoff (approximately 52 months)|Randomized participant population with a measurable lesion at baseline.||percentage of participants||95% Confidence Interval|Number
842086|NCT01390948|Secondary|EFS as Assessed by the Investigator|EFS was defined as the time from diagnosis to the earliest occurrence of any of the following: tumor progression, tumor recurrence, second primary non-HGG malignancy or death attributable to any cause. Tumor assessments were conducted using MRI and reviewed by the investigator using RANO criteria. Tumor progression was defined as clear clinical progression or >/= 25% increase in the sum of the products of perpendicular diameters of the contrast enhancing lesions compared with the smallest tumor measurement obtained either at baseline (if no decrease was observed) or best response and with the participant on stable or increasing doses of corticosteroids. Tumor recurrence was defined as recurrence after tumor was completely resected (no disease present at baseline). EFS was estimated using the Kaplan-Meier method.|From the time of randomization to the date of any defined event (up to approximately 52 months)|Randomized participant population included all randomized participants regardless of whether they received study treatment.||months||95% Confidence Interval|Median
842087|NCT01390948|Secondary|Percentage of Participants With EFS as Determined by the CRRC at 1 Year|EFS was defined as the time from diagnosis to the earliest occurrence of any of the following: tumor progression, tumor recurrence, second primary non- HGG malignancy or death attributable to any cause. Tumor assessments were conducted using MRI and reviewed by the site-independent CRRC using RANO criteria. Tumor progression was defined as clear clinical progression or >/= 25% increase in the sum of the products of perpendicular diameters of the contrast enhancing lesions compared with the smallest tumor measurement obtained either at baseline (if no decrease was observed) or best response and with the participant on stable or increasing doses of corticosteroids. Tumor recurrence was defined as recurrence after tumor was completely resected (no disease present at baseline). EFS was estimated using the Kaplan-Meier method.|1 year|Randomized participant population included all randomized participants regardless of whether they received study treatment.||percentage of participants||95% Confidence Interval|Number
842088|NCT01390948|Secondary|Percentage of Participants With EFS as Determined by the CRRC at 6 Months|EFS was defined as the time from diagnosis to the earliest occurrence of any of the following: tumor progression, tumor recurrence, second primary non- HGG malignancy or death attributable to any cause. Tumor assessments were conducted using MRI and reviewed by the site-independent CRRC using RANO criteria. Tumor progression was defined as clear clinical progression or >/= 25% increase in the sum of the products of perpendicular diameters of the contrast enhancing lesions compared with the smallest tumor measurement obtained either at baseline (if no decrease was observed) or best response and with the participant on stable or increasing doses of corticosteroids. Tumor recurrence was defined as recurrence after tumor was completely resected (no disease present at baseline). EFS was estimated using the Kaplan-Meier method.|6 months|Randomized participant population included all randomized participants regardless of whether they received study treatment.||percentage of participants||95% Confidence Interval|Number
842089|NCT01390948|Secondary|Percentage of Participants With 1-Year Survival|1-year survival was estimated using the Kaplan-Meier method.|1 year|Randomized participant population included all randomized participants regardless of whether they received study treatment.||percentage of participants||95% Confidence Interval|Number
842090|NCT01390948|Secondary|Overall Survival|Overall Survival was defined as the time of diagnosis to the date of death due to any cause. Overall Survival was estimated using the Kaplan-Meier method.|From the time of randomization to the date of death (up to approximately 52 months)|Randomized participant population included all randomized participants regardless of whether they received study treatment.||months||95% Confidence Interval|Median
842091|NCT01390948|Primary|Event-Free Survival (EFS) as Assessed by the Central Radiology Review Committee (CRRC)|EFS was defined as the time from diagnosis to the earliest occurrence of any of the following: tumor progression, tumor recurrence, second primary non-high-grade glioma (HGG) malignancy or death attributable to any cause. Tumor assessments were conducted using magnetic resonance imaging (MRI) and reviewed by the site-independent CRRC using Response Assessment in Neuro-Oncology (RANO) criteria. Tumor progression was defined as clear clinical progression or a greater than or equal to (>/=) 25% increase in the sum of the products of perpendicular diameters of the contrast enhancing lesions compared with the smallest tumor measurement obtained either at baseline (if no decrease was observed) or best response and with the participant on stable or increasing doses of corticosteroids. Tumor recurrence was defined as recurrence after tumor was completely resected (no disease present at baseline). EFS was estimated using the Kaplan-Meier method.|From the time of randomization to the date of any defined event (up to approximately 52 months)|Randomized participant population included all randomized participants regardless of whether they received study treatment.||months||95% Confidence Interval|Median
842092|NCT01383928|Secondary|Phase 2: Overall Survival|Overall survival was measured as the time from the date of first dose of study treatment to the time of death plus 1 day. For participants who did not die, survival was censored at the date of last contact. Overall Survival was analyzed using standard survival analysis techniques based on Kaplan-Meier estimates.|Baseline up to treatment cycle 35|mITT population included all participants who received at least 1 dose of any study drug in Phase 2 or who received at least 1 dose of any study drug and were treated at the phase 2 dose level during Phase 1.||months||95% Confidence Interval|Median
842093|NCT01383928|Secondary|Phase 2: Percentage of Participants Achieving Survival at Year 1||1 year after the first dose of study treatment|mITT population included all participants who received at least 1 dose of any study drug in Phase 2 or who received at least 1 dose of any study drug and were treated at the phase 2 dose level during Phase 1.||participants||95% Confidence Interval|Number
842094|NCT01383928|Secondary|Phase 2: Progression Free Survival (PFS)|PFS was defined as the time from the date of first dose of study treatment to the date of first documentation of progressive disease or to death due to any cause, whichever occurred first plus 1. PD: >=25% increase from lowest value in:serum/urine M-component; difference between involved,uninvolved FLC levels; bone marrow plasma cell percent; new bone lesions/soft tissue plasmacytomas development/existing bone lesions/soft tissue plasmacytomas size rise; hypercalcaemia development. SD: not meeting criteria for CR, VGPR, PR, or PD. Participants who received ASCT or an alternate anticancer therapy were censored at the last response assessment that was SD or better before initiation of therapy. Participants without a response assessment were censored at the date of first dose. PFS was analyzed using standard survival analysis techniques based on Kaplan-Meier estimates.|Baseline until progressive disease (up to treatment cycle 35)|mITT population included all participants who received at least 1 dose of any study drug in Phase 2 or who received at least 1 dose of any study drug and were treated at the phase 2 dose level during Phase 1.||months||95% Confidence Interval|Median
842106|NCT01383928|Secondary|Phase 2: Percentage of Participants With Complete Response (CR) and Very Good Partial Response (VGPR) After Cycles 4, 8, and 16|CR as per IMWG criteria is defined as negative immunofixation on the serum and urine and disappearance of soft tissue plasmacytomas and <5% plasma cells in bone marrow. VGPR as per IMWG criteria is defined as serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100 mg per 24 hours. VGPR were applicable only to participants who had measurable disease defined by at least 1 of the following 3 measurements: Serum M-protein; Urine M-protein; Serum FLC assay.|Cycles 4, 8, and 16|Response-evaluable population included all participants who received at least one 1 dose of ixazomib, had measurable disease at baseline, and at least one 1 post-baseline disease assessment.||percentage of participants||95% Confidence Interval|Number
842095|NCT01383928|Secondary|Phase 2: Time to Disease Progression (TTP)|Time to progression was defined as the time from the date of first dose of study treatment to the date of first documentation of PD + 1 day. Participants that did not experience PD will be censored at the last response assessment that is SD or better. PD: >=25% increase from lowest value in:serum/urine M-component; difference between involved, uninvolved FLC levels; bone marrow plasma cell percent; new bone lesions/soft tissue plasmacytomas development/existing bone lesions/soft tissue plasmacytomas size rise; hypercalcaemia development. SD: not meeting criteria for CR, VGPR, PR, or PD. Participants that received Autologous Stem Cell Transplantation (ASCT) or an alternate cancer therapy were also be censored at the last response assessment that is, SD or better prior to initiation of therapy. Participants without response assessment will be censored at the date of first dose. TTP was analyzed using standard survival analysis techniques based on Kaplan-Meier estimates.|Baseline until progressive disease (up to treatment cycle 35)|modified-intent-to-treat (mITT) population included all participants who received at least one dose of any study drug in Phase 2 or who received at least 1 dose of any study drug and were treated at the phase 2 dose level during Phase 1.||months||95% Confidence Interval|Median
842096|NCT01383928|Secondary|Phase 2: Duration of Response (DOR)|DOR was measured as the time from the date of first documentation of a confirmed response to the date of first documented PD. PD is defined as >=25% increase from lowest value in: serum/urine M-component; difference between involved, uninvolved FLC levels; bone marrow plasma cell percent; development of new bone lesions or soft tissue plasmacytomas development or increase in the size of existing bone lesions or soft tissue plasmacytomas; hypercalcaemia development.|Baseline until end of study treatment (up to treatment cycle 35)|Included a subset of response-evaluable population who achieved response.||months||95% Confidence Interval|Median
842097|NCT01383928|Secondary|Phase 2: Time to Response|Time to first response is defined as the time from the date of first dose of study treatment to the date of the first documentation of a confirmed response (PR or better) in a participant who responded + 1 day. PR as per IMWG criteria is 50% reduction of serum M-protein and reduction in 24-h urinary M-protein by 90% or to <200 mg per 24 hours.|Baseline until end of study treatment (up to treatment cycle 35)|Response-evaluable population included all participants who received at least 1 dose of study drug, had measurable disease at baseline, and at least 1 post-baseline response assessment.||months||Full Range|Median
842098|NCT01383928|Primary|Phase 2: Percentage of Participants With Treatment-Emergent Adverse Events Resulting in Study Drug Discontinuation|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.|Baseline up to 30 days after last dose of study drug|Safety population included all participants who received at least 1 dose of any study drug.||percentage of participants|||Number
842099|NCT01383928|Primary|Phase 2: Percentage of Participants Experiencing Serious Adverse Events|A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event.|Baseline up to 30 days after last dose of study drug|Safety population included all participants who received at least one dose of any study drug.||percentage of participants|||Number
842100|NCT01383928|Secondary|Phase 2: Percentage of Participants With Minimal Response (MR)|MR as per IMWG criteria is 25%-49% reduction in serum paraprotein and 50%-89% reduction in urine light chain excretion for 6 weeks.|Baseline until end of study treatment (up to treatment cycle 35)|Response-evaluable population included all participants who received at least 1 dose of ixazomib, had measurable disease at baseline, and at least 1 post-baseline disease assessment.||percentage of participants||95% Confidence Interval|Number
842101|NCT01383928|Secondary|Phase 2: Percentage of Participants With Partial Response (PR)|PR as per IMWG criteria is 50% reduction of serum M-protein and reduction in 24-hr urinary M-protein by 90% or to <200 mg per 24 hours.|Baseline until end of study treatment (up to treatment cycle 35)|Response-evaluable population included all participants who received at least 1 dose of ixazomib, had measurable disease at baseline, and at least 1 post-baseline disease assessment.||percentage of participants||95% Confidence Interval|Number
842102|NCT01383928|Secondary|Phase 2: Percentage of Participants With Near Complete Response (nCR)|nCR as per IMWG criteria is positive immunofixation analysis of serum or urine as the only evidence of disease; appearance of any soft tissue plasmacytomas and <=5% plasma cells in bone marrow.|Baseline until end of study treatment (up to treatment cycle 35)|Response-evaluable population included all participants who received at least 1 dose of ixazomib, had measurable disease at baseline, and at least 1 post-baseline disease assessment.||percentage of participants||95% Confidence Interval|Number
842103|NCT01383928|Secondary|Phase 2: Percentage of Participants With Very Good Partial Response (VGPR)|VGPR as per IMWG criteria is serum and urine M-protein detectable by immunofixation but not on electrophoresis or >=90% reduction in serum M-protein plus urine M-protein level <100 mg per 24 hours.|Baseline until end of study treatment (up to treatment cycle 35)|Response-evaluable population included all participants who received at least 1 dose of ixazomib, had measurable disease at baseline, and at least 1 post-baseline disease assessment.||percentage of participants||95% Confidence Interval|Number
842104|NCT01383928|Secondary|Phase 2: Percentage of Participants With Stringent Complete Response (sCR)|sCR as per IMWG criteria is CR plus normal FLC ratio and absence of clonal cells in bone marrow. CR is negative immunofixation on serum and urine and disappearance of soft tissue plasmacytomas and <5% plasma cells in bone marrow.|Baseline until end of study treatment (up to treatment cycle 35)|Response-evaluable population included all participants who received at least one 1 dose of ixazomib, had measurable disease at baseline, and at least one 1 post-baseline disease assessment.||percentage of participants||95% Confidence Interval|Number
842105|NCT01383928|Secondary|Phase 2: Pecentage of Participants With Complete Response (CR)|CR as per IMWG criteria is negative immunofixation on serum and urine and disappearance of soft tissue plasmacytomas and <5% plasma cells in bone marrow.|Baseline until end of study treatment (up to treatment cycle 35)|Response-evaluable population included all participants who received at least 1 dose of ixazomib, had measurable disease at baseline, and at least 1 post-baseline disease assessment.||percentage of participants||95% Confidence Interval|Number
842107|NCT01383928|Secondary|Phase 2: Percentage of Participants With Objective Response|Objective response is defined as CR, VGPR or PR based on IMWG Response Criteria for malignant lymphoma. CR: disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. VGPR: serum, urine M-protein detectable by immunofixation but not on electrophoresis or >=90% reduction in serum M-protein+urine M-protein level <100 mg/24h. Partial response (PR) is a minimum of 50% decrease in sum of the product of the diameters of up to 6 of the largest dominant nodes or nodal masses and no increase in the size of other nodes.|Baseline until end of study treatment (up to Cycle 35)|Response-evaluable population included all participants who received at least 1 dose of ixazomib, had measurable disease at baseline, and at least 1 post-baseline disease assessment.||percentage of participants||95% Confidence Interval|Number
842108|NCT01383928|Primary|Phase 2: Percentage of Participants With Grade 3 or Higher Adverse Events|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. As per Common Terminology Criteria for Adverse Events v4.0 (CTCAE), Grade 3 = AE with severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4 = AE with life-threatening consequences; urgent intervention indicated and Grade 5 = Death related to AE.|Baseline up to 30 days after last dose of study drug|Safety population included all participants who received at least 1 dose of any study drug.||percentage of participants|||Number
842109|NCT01383928|Primary|Phase 2: Percentage of Participants With Complete Response (CR) + Very Good Partial Response (VGPR)|CR as per International Myeloma Working Group (IMWG) uniform criteria is defined as negative immunofixation on the serum and urine and disappearance of soft tissue plasmacytomas and <5% plasma cells in bone marrow. VGPR as per IMWG criteria is defined as serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100 mg per 24 hours. VGPR was applicable only to participants who had measurable disease defined by at least 1 of the following 3 measurements: Serum M-protein greater than or equal to (>=)1 g/dL; Urine M-protein >=200 mg/24 hours; Serum FLC assay level >=10 mg/dL, provided serum FLC ratio was abnormal.|Baseline up to treatment cycle 35|Response-evaluable population included all participants who received at least 1 dose of study drug, had measurable disease at baseline, and at least 1 post-baseline response assessment.||percentage of participants||95% Confidence Interval|Number
842110|NCT01383928|Primary|Phase 1: Number of Participants With Clinically Significant Change From Baseline in Vital Signs|Vital signs included body temperature, blood pressure and heart rate.|Baseline and Day 1 of each treatment cycle up to 35 treatment cycles|Safety population included all participants who received at least 1 dose of any study drug.||participants|||Number
842111|NCT01383928|Primary|Phase 1: Number of Participants With Treatment-Emergent Adverse Events (TEAE) Related to Neurotoxicity|TEAE related to neurotoxicity grading based on common terminology criteria for adverse events (CTACE) version 4.03 are reported. Grade 1= mild; Grade 2= moderate; within normal limits, Grade 3= severe or medically significant but not immediately life-threatening; Grade 4= life-threatening consequences; urgent intervention indicated; Grade 5= death.|Baseline up to 30 days after last dose of study drug|Safety population included all participants who received at least 1 dose of any study drug and reported baseline and at least 1 post-baseline value.||participants|||Number
842112|NCT01383928|Primary|Phase 1: Number of Participants With Change From Baseline Value in Clinical Laboratory Test Results to Worst Value|Number of participants with any markedly abnormal standard safety laboratory values collected throughout study. Hematology (white blood cell [WBC] count, lymphocytes, neutrophils, platelets, hemoglobin), clinical chemistry and urinalysis were performed. Number of participants with baseline laboratory values as per National Cancer Institute Common Terminology Criteria (NCI CTC) grade (Grade 0= within normal limits, Grade 1=Mild, Grade 2=Moderate, Grade 3= Severe, Grade 4= Life-threatening) and corresponding changes to the worst CTC grade were presented. Baseline value defined as value collected at time closest to, but prior to, first dose of study drug on Cycle 1 Day 1. Worst post-baseline value defined as worst value between first dose of any study drug and End of Study (EOS) visit. Shift to low refers to lower than Baseline value; shift to high refers to higher than baseline value for corrected calcium, glucose, magnesium, potassium and sodium irrespective of change in the CTC grade.|Baseline and Cycle 1 up to Cycle 35|Safety population included all participants who received at least 1 dose of any study drug and reported baseline and at least 1 post-baseline value.||participants|||Number
842113|NCT01383928|Secondary|Phase 1: Percentage of Participants With Best Overall Response|Best response observed during study.CR:no immunofixation on serum,urine;soft tissue plasmacytomas disappearance;<5% plasma cells in bone marrow.Stringent CR(sCR):CR as defined,normal free light chain ratio,absence of clonal cells in bone marrow.Partial response(PR):>=50% reduction of serum M-protein,urinary M-protein by >=90%/to <200 mg/24 hr reduction.Near CR(nCR):positive immunofixation of serum/urine;soft tissue plasmacytomas disappearance;<=5% plasma cells in bone marrow.VGPR:serum,urine M-protein detectable by immunofixation but not on electrophoresis/>=90% reduction in serum M-protein+urine M-protein level <100 mg/24hr.Stable disease (SD):failure to attain CR,VGPR,PR/progressive disease (PD).PD:>=25% increase from lowest value in:serum/urine M-component;difference between involved,uninvolved FLC levels;bone marrow plasma cell percent;new bone lesions/soft tissue plasmacytomas development/existing bone lesions/soft tissue plasmacytomas size rise;hypercalcaemia development.|Baseline until end of study treatment (up to Cycle 35)|Response-evaluable population included all participants who received at least 1 dose of ixazomib, had measurable disease at baseline, and at least 1 post-baseline disease assessment. Results were summarized together for all Phase 1 participants, as per planned analysis. Participants may be represented in more than 1 category.||percentage of participants||95% Confidence Interval|Number
842114|NCT01383928|Secondary|Phase 1: Rac: Accumulation Ratio of Ixazomib|The accumulation ratio (Rac) was estimated as the ratio of AUC (0-72) on Day 11 to the AUC (0-72) on Day 1. AUC (0-72) is the area under the plasma concentration-time curve from time zero to 72 hours post-dose for ixazomib.|Cycle 1, Days 1 and 11|PK analysis population included all participants, who had sufficient dosing data and ixazomib concentration-time data to permit calculation of PK parameters where Days 1 and 11 assessments were available.||ratio||Standard Deviation|Geometric Mean
842116|NCT01383928|Secondary|Phase 1: AUC(0-72): Area Under the Plasma Concentration-Time Curve From Time 0 to 72 Hours Postdose for Ixazomib|AUC(0-72) is a measure of the area under the plasma concentration time-curve from time zero to 72 hours post-dose for ixazomib.|Cycle 1, Days 1 and 11|PK analysis population included all participants, who had sufficient dosing data and ixazomib concentration-time data to permit calculation of PK parameters where Days 1 and 11 assessments were available.||hour*nanogram per milliliter (hr*ng/mL)||Standard Deviation|Geometric Mean
842117|NCT01383928|Secondary|Phase 1: Cmax: Maximum Plasma Concentration for Ixazomib|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of ixazomib, obtained directly from the plasma concentration-time curve.|Cycle 1, Days 1 and 11|Pharmacokinetic (PK) analysis population included all participants who had sufficient dosing data and ixazomib concentration-time data to permit calculation of PK parameters where Days 1 and 11 assessments were available.||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
842118|NCT01383928|Primary|Phase 1: Percentage of Participants Experiencing 1 or More Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.|Baseline up to 30 days after last dose of study drug|Safety population included all participants who received at least 1 dose of any study drug.||percentage of participants|||Number
842119|NCT01383928|Primary|Phase 1: Recommended Phase 2 Dose (RP2D)|The RP2D of ixazomib was determined after the evaluation of the available data from the phase 1 portion of the trial which included, but was not limited to analyses of efficacy results, toxicity characterization, all grades peripheral neuropathy, and treatment discontinuation.|Cycle 1 up to Cycle 35|Safety population included all participants who received at least 1 dose of any study drug.||mg|||Number
842120|NCT01383928|Primary|Phase 1: Maximum Tolerated Dose (MTD)|MTD was highest dose of ixazomib given with combination drugs, at which <=1 of 6 participants experienced dose-limiting toxicity (DLT) during Cycle 1 of Phase 1. DLT defined as any of following considered possibly related to therapy: Grade 4 neutropenia (absolute neutrophil count [ANC] <500 cell per cubic millimeter [cells/mm^3]) for >7 days; Grade 3 neutropenia with fever or infection; Grade 4 thrombocytopenia for >7 days; Grade 3 thrombocytopenia with clinically significant bleeding; platelet count <10,000/mm^3; Grade 2 peripheral neuropathy with pain or >=Grade 3 peripheral neuropathy; >=Grade 3 nausea/emesis, diarrhea controlled by supportive therapy; any >=Grade 3 nonhematologic toxicity except Grade 3 arthralgia/myalgia; or <1 week Grade 3 fatigue; delay in initiation of the subsequent therapy cycle by >14 days; <=80% lenalidomide doses administered due to other >=Grade 2 combination study drug-related nonhematologic toxicities requiring therapy discontinuation.|Cycle 1|DLT-evaluable population included all participants who received all Cycle 1 doses of MLN9708 and completed Cycle 1 procedures, or experienced a DLT in Cycle 1 in Phase 1.||mg|||Number
842169|NCT01252095|Primary|Maximum Tolerated Dose (MTD) Based on DLT|The primary objective of this study is the determination of the MTD. Due to the premature termination of the study the MTD could not be determined. The outcome measure presented is the number of DLTs per cohort.|Following first 1 month cycle|Patients had to complete cycle 1 per protocol.||DLTs|||Number
842170|NCT01244477|Secondary|PTSD Checklist (PCL)|An instrument measuring a participants self-reported level of PTSD symptoms. PCL scores are the sum of 17 questions. Each is question is scored from 1 (best possible outcome) to 5 (worst possible outcome). The lowest possible PCL score is a 17, indicating no troublesome PTSD symptoms reported. The highest possible PCL score is a 85, indicating the worst degree of PTSD symptoms reported.|Administered each week at weekly group sessions or pre-post treatment as usual|Veterans under 50 years of age diagnosed with PTSD||PCL Scores||Standard Deviation|Mean
842171|NCT01244477|Secondary|Behavioral Expression of Trust on the Trust Game|The Investment Ratio (IR) is the amount subjects were willing to invest in a social partner. It is considered a measure of interpersonal trust, and co-operation. It is a ratio ranging from 0 (indicating no willingness to trust a social partner) to 1.0 (willing to totally trust a social partner). It consists of the percentage of total points the subject was willing to invest in a social partner divided by the total points they received for all ten rounds of the trust game. Higher ratio's indicate more trust.|Pre & post a 12 week treatment group|Veterans with PTSD under 50 years of age||Ratio||Standard Deviation|Mean
842210|NCT00953225|Secondary|Number of Positive Biopsy Cores (Out of Twelve) Compared to the Corresponding Values Assessed Before Enrollment|Change in the number of positive cores per subject from the pre-study prostate biopsy to the repeat prostate biopsy following study participation.|1 year|Each subject had 12 cores measured at each of the pre and post prostate biopsies. The variable summarized is the number of positive cores per subject.||cores per subject||Inter-Quartile Range|Median
842172|NCT01244477|Primary|The Clinician Administered PTSD Scale (CAPS)|The CAPS is considered the gold standard measure of PTSD symptoms. CAPS scores are the sum of 17 questions. Each is question is scored from 0 (best possible outcome) to 8 (worst possible outcome). The lowest possible CAPS score is a 0, indicating no PTSD symptoms reported. The highest possible CAPS score is a 136, indicating the most PTSD symptoms reported.|Pre & post a 12 week treatment group|We limited this arm to 18 subjects who completed 9+ out of 12 treatment sessions.||CAPS Scores||Standard Deviation|Mean
842173|NCT01244477|Primary|Continuous Whole Brain Imaging With Standard Imaging Parameters for Each Functional Magnetic Resonance Imaging (fMRI) Scan||Pre & post a 12 week treatment group||||||
842174|NCT01225887|Secondary|Progression Free Survival|the period of progression free survival for patients with persistent or recurrent endometrial cancer treated with study drug.|The duration of time from study entry to time of progression or death, whichever occurs first, assessed up to 5 years|The time in months that a patient survived progression-free.||months||90% Confidence Interval|Median
842175|NCT01225887|Secondary|Overall Survival|The observed length of life from entry into the study to death or the date of last contact.|From study entry to death or last contact, up to 5 years|Eligible and treated patients||months||95% Confidence Interval|Median
842176|NCT01225887|Primary|Progression-free Survival > 6 Months|Whether or not the patient survived progression-free for at least 6 months.|for disease that can be evaluated by physical exam, progression was assessed prior to each cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle up to 5 years.|Eligible and Treated Patients||percentage of participants||90% Confidence Interval|Number
842177|NCT01225887|Primary|Objective Tumor Response|Complete and Partial Tumor Response by RECIST 1.1|For disease that can be evaluated by physical exam,response was assessed prior to each cycle CT scan or MRI if used to follow lesion for measurable disease every other cycle up to 5 years.|Eligible and Treated Patients||percentage of participants||90% Confidence Interval|Number
842178|NCT01225887|Primary|Number of Participants With Adverse Events|The incidence of adverse events (grade 3 or higher) as assessed by the National Cancer Institute CTCAE version 4.0|Up to 5 years|Patients on study who experienced adverse events (Grade 3 or higher)||Participants|||Count of Participants
842179|NCT01180049|Secondary|Quantify the Potential Effect of TEMSR on AUC and Cmax|"Potential TEMSR effects were investigated by calculating the ratio of AUCs with and without concomitant TEMSR from the model-estimated effect of TEMSR on apparent clearance (CL/F) values and using individual ratios of observed Cmax values with and without concomitant temsirolimus, for both parent and metabolite. The AUC mean ratio was calculated as 1 / mean shift on apparent clearance from TEMSR, and the 90% CI of the AUC ratios was calculated as 1 / 90% CI of the shift on apparent clearance from TEMSR.
AUC: Area under plasma concentration-time curve from time zero to infinity Cmax: Characterization of maximum observed plasma concentration"|From one week predose (Day -7, -4hr, -8hr, -48hr) upto 2 weeks post dose (4hr, 8hr, 48hr and Day 8)|The analysis was done on ITT Population which included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug dose from that to which they were randomized.||Ratio||90% Confidence Interval|Mean
842180|NCT01180049|Secondary|Percentage of Participants With Treatment-emergent Bleeding-related AEs|"To assess the safety through percentage of participants with treatment-emergent bleeding-related AEs (Grade 2 or Higher).
TEAE: Treatment start date ≤ adverse event start date or adverse event worsened with respect to grade after treatment started"|From screening (Day -28 to Day -1) until end of treatment (within 30 days of last TEMSR infusion)|Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR was included in the evaluation for safety||Percentage of participants|||Number
842181|NCT01180049|Secondary|Percentage of Participants With Treatment-emergent Infection- Related AEs|To assess the safety through percentages of participants with treatment-emergent infection- related AEs TEAE: Treatment start date ≤ adverse event start date or adverse event worsened with respect to grade after treatment started|From screening (Day -28 to Day -1) until end of treatment (within 30 days of last TEMSR infusion)|Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR was included in the evaluation for safety||Percentage of participants|||Number
842182|NCT01180049|Secondary|Investigator Assessed PFS|"PFS is defined as the time from randomization to first documentation of disease progression by the independent assessor or to death due to any cause, whichever occurred first.
PFS = (earliest date of progression or death due to any cause- randomization date+1)/30.4.
PFS assessment was done using EMA guidelines for sensitivity analysis censoring.
Participants who were alive and progression-free at the time of analysis were censored on the date of last assessment; participants without adequate baseline assessment or without post-baseline assessments were censored on the randomization date; participants who died or progressed after 2 or more missed visits were censored on the date of last tumor assessment prior to the missing visit; and participants who started new anti-cancer therapy prior to death or progression were censored on the date of last tumor assessment prior to the start of anti-tumor treatment."|From randomization date to the date of first documentation of progression or death (average follow up done for 15 months)|The analysis was done on ITT population which included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug dose from that to which they were randomized.||Months||80% Confidence Interval|Median
842183|NCT01180049|Secondary|Investigator’s Assessment ORR (ORR = CR + PR)|"ORR is defined as the percentage of participants with confirmed CR or PR according to the Cheson Criteria relative to all randomized Participants. Tumor responses were determined using information from objective measurements from computed tomography information including B-symptom evaluation, physical examination, ECOG performance status, assessment of liver and spleen, laboratory assessments such as bone marrow biopsies and/or aspirates, biochemical markers of disease activity and hematology results.
Participants who did not have on-study radiographic tumor re-evaluation or who died, progressed or dropped out for any reason prior to reaching a CR or PR were counted as non-responders in the (CT) scans, as well as clinical assessment of ORR."|From randomization date until end of treatment (average follow up done for 15 months)|The analysis was done on ITT population which included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug dose from that to which they were randomized.||Percentage of participants||80% Confidence Interval|Number
842184|NCT01180049|Secondary|Independent Assessment - Objective Response Rate (ORR = CR + PR)|"ORR is defined as the percentage of participants with confirmed CR or PR according to the Cheson Criteria relative to all randomized Participants. Tumor responses were determined using information from objective measurements from computed tomography information including B-symptom evaluation, physical examination, ECOG performance status, assessment of liver and spleen, laboratory assessments such as bone marrow biopsies and/or aspirates, biochemical markers of disease activity and hematology results.
Participants who did not have on-study radiographic tumor re-evaluation or who died, progressed or dropped out for any reason prior to reaching a CR or PR were counted as non-responders in the (CT) scans, as well as clinical assessment of ORR."|From randomization date until end of treatment (average follow up done for 15 months)|The analysis was done on ITT population which included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug dose from that to which they were randomized.||Percentage of participants||80% Confidence Interval|Number
842185|NCT01180049|Secondary|Overall Survival (OS)|OS is defined as the time from the date of randomization to the date of death due to any cause.|From randomization date until death (average follow up done for 18.6 months)|The analysis was done on ITT population which included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug dose from that to which they were randomized.||Months||80% Confidence Interval|Median
842186|NCT01180049|Primary|Independently Assessed Progression-free Survival (PFS)|"PFS is defined as the time from randomization to first documentation of disease progression by the independent assessor or to death due to any cause, whichever occurred first.
PFS = (earliest date of progression or death due to any cause- randomization date+1)/30.4.
PFS assessment was done using EMA guidelines for sensitivity analysis censoring.
Participants who were alive and progression-free at the time of analysis were censored on the date of last assessment; participants without adequate baseline assessment or without post-baseline assessments were censored on the randomization date; participants who died or progressed after 2 or more missed visits were censored on the date of last tumor assessment prior to the missing visit; and participants who started new anti-cancer therapy prior to death or progression were censored on the date of last tumor assessment prior to the start of anti-tumor treatment."|From randomization date to the date of first documentation of progression or death (average follow up done for 15 months)|The analysis was done on ITT population which included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug dose from that to which they were randomized.||Months||80% Confidence Interval|Median
842211|NCT00953225|Primary|PSA Slope (Trajectory) or the Change in PSA Level Over Time|Change in PSA (ng/mL) from baseline to 1 year visit, which include the baseline through 1 year follow-up.|1 year (visits # 1-8)|Linear regression was applied to each subject's data with Log(PSA +1) as the outcome. Based on the fitted model, the change in PSA from visit #1 (baseline) to visit #8 (1 year) was calculated. This derived change score is summarized by group.||ng/mL||Inter-Quartile Range|Median
842207|NCT00966446|Secondary|Time to Clearance of Methicillin-resistant Staphylococcus Aureus (MRSA) Colonization|Surveillance cultures negative for two consecutive sampling periods; date of clearance determined as midpoint between date of last positive surveillance culture and first negative surveillance culture.|Within 6 months|Subjects who returned samples for at least the first two consecutive sampling periods were included in analysis, as this was necessary to determine clearance of MRSA colonization||days||95% Confidence Interval|Median
842208|NCT00966446|Primary|First Two Consecutive Sampling Periods Completed|Subjects who returned samples for at least the first two consecutive sampling periods were included in analysis|Within 2 months|These subjects sent in two consecutive swab samples starting with their first follow-up time point.||participants|||Number
842209|NCT00966446|Primary|Recurrent Infection|Confirmed new MRSA infections|Within 6 months|These study participants who self-reported re-infections of MRSA||participants|||Number
842237|NCT00878709|Secondary|Overall Survival (OS)|Overall survival is defined as the time from randomization to death from any cause|From time of randomization to death||07/2019||||
842216|NCT00903409|Secondary|Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial|Median percent change from LOV111858 End-of-Treatment (Week 8) to LOV111818 Months 4, 12, and 24 visits of the open-label extension trial|LOV111858 End-of-Treatment (Week 8) to LOV111818 Months 4, 12, and 24 of the open-label extension trial|ITT Population||Percentage change||Full Range|Median
842217|NCT00903409|Secondary|Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in “Switchers” vs. Non-switchers|Median percent change from LOV111858 Baseline to LOV111818 Months 4, 12, and 24 visits of the open-label extension trial|Months 4, 12, and 24 (LOV111818) of the open-label extension trial|ITT Population||Percent change||Full Range|Median
842218|NCT00903409|Primary|Median Percent Change of Non-HDL-C (High Density Lipoprotein-Cholesterol) in Switchers vs. Non-Switchers Subjects From LOV111858 End-of-Treatment (Week 8) to Month 4 of Extension Study (LOV111818)|Median percent change from LOV111858 (NCT00903409) End-of-Treatment (double-blind study, Week 8) to the Month 4 visit of LOV111818 (open-label extension trial)|Month 4 (LOV111818)|Intent-to-Treat (ITT) Population: Comprised of data for all participants who were enrolled and received at least one dose of study medication||Percent change||Full Range|Median
842219|NCT00892775|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/ incapacity or is a congenital anomaly/ birth defect in the offspring of a study subject.|From first study dose (Day 0) until study end (Week 18)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.||Participants|||Count of Participants
842220|NCT00892775|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Event (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Also any ‘solicited’ symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. Grade 3 was defined as an event that prevented normal activity and Related was defined as an event assessed by the investigator as causally related to the study vaccination.|Within 43 days (Days 86-128) after second vaccination dose|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.||Participants|||Count of Participants
842221|NCT00892775|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Event (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Also any ‘solicited’ symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. Grade 3 was defined as an event that prevented normal activity and Related was defined as an event assessed by the investigator as causally related to the study vaccination.|Within 43 days (Days 0-42) after first vaccination dose|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.||Participants|||Count of Participants
842222|NCT00892775|Secondary|Number of Subjects Reporting Any (Local or General), Grade 3 and Related Rashes|Rash was defined as: 1) measles/ rubella rashes (macular or maculo-papular rashes): presence of macules, discolored small patches or spots of the skin, neither elevated nor depressed below the skin’s surface; 2) varicella rash (maculo-papulo-vesicular): simultaneous presence of macules, papules and vesicles raised above the skin’s surface; 3) other types of rash (heat rash, diaper rash etc.). Any rash = occurrence of rash regardless of intensity grade or relationship to vaccination Grade 3 rash ≥ 150 lesions and Related = rash assessed by the investigator as related to the vaccination.|Within 43 days (Days 0-42) after each vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects, with the symptom sheet filled-in.||Participants|||Count of Participants
842223|NCT00892775|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Fever|Any fever was defined as fever greater than or equal to (≥) 38.0 Celsius degrees (°C) and grade 3 fever greater than (>) 39.5°C after vaccination. Related fever was defined as fever assessed by the investigator as related to the vaccination.|Within 43 days (Days 0-42) after each vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects, with the symptom sheet filled-in.||Participants|||Count of Participants
842606|NCT01797458|Primary|Failure Rate of the Three Treatment Arms Judged Clinically|Failure rate of the three treatment arms judged clinically after 2 years such as clear caries progression, secondary caries, loss of restoration, reversible pulpitis treated without requiring pulpotomy|2 years|||Participants|||Count of Participants
842224|NCT00892775|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms|Assessed solicited general symptoms were meningism and parotid gland swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 meningism and parotid gland swelling = meningism/ parotid gland swelling which prevented normal everyday activities.|Within 43 days (Days 0-42) after each vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects,with the symptom sheet filled-in.||Participants|||Count of Participants
842225|NCT00892775|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/ spontaneously painful. Grade 3 redness/ swelling = redness/ swelling spreading beyond 20 millimeters (mm) of injection site.|Within 4 days after each vaccination (Days 0-3)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects, with the symptom sheet filled-in.||Participants|||Count of Participants
842226|NCT00892775|Secondary|Antibody Titers Against Measles, Mumps, Rubella and Varicella Viruses|Antibody titers were summarized by geometric mean titers (GMTs) with their 95% confidence intervals.|At 42-56 days after the first and second dose of study vaccine(s).|The ATP cohort for immunogenicity included all eligible subjects who were seronegative at baseline to at least one vaccine antigen, who had received the comparator vaccine according to their random assignment, who had not received a vaccine not specified/ forbidden in the protocol and for whom pre/ post-vaccination serology results were available.||Titres||95% Confidence Interval|Geometric Mean
842227|NCT00892775|Secondary|Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies ≥ the Cut-off Value.|Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. The cut-off values for seroconversion was 150 mIU/mL, 231 U/mL, 4 IU/mL and 1:4 dilution for measles, mumps, rubella and varicella, respectively.|At 42-56 days after the second dose of study vaccine (Week 18)|The ATP cohort for immunogenicity included all eligible subjects who were seronegative at baseline to at least one vaccine antigen, who had received the comparator vaccine according to their random assignment, who had not received a vaccine not specified/ forbidden in the protocol and for whom pre/ post-vaccination serology results were available.||Participants|||Count of Participants
842228|NCT00892775|Primary|Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies Greater Than or Equal to (≥) the Cut-off Value.|Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. The cut-off values for seroconversion was 150 milli international units per milliliter (mIU/mL), 231 units per milliliter (U/mL), 4 international units per milliliter (IU/mL) and 1:4 dilution for measles, mumps, rubella and varicella, respectively.|At 42-56 days after the first dose of study vaccine (Week 6)|The ATP cohort for immunogenicity included all eligible subjects who were seronegative at baseline to at least one vaccine antigen, who had received the comparator vaccine according to their random assignment, who had not received a vaccine not specified/ forbidden in the protocol and for whom pre/ post-vaccination serology results were available.||Participants|||Count of Participants
842229|NCT00878709|Secondary|Cumulative Incidence of Central Nervous System Recurrence (CNS) at Year 2|Cumulative incidence of Central Nervous System Recurrence (CNS) is estimated by Gray’s method (Gray,1988).|From randomization until time of event up to 2 years|Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment.||percentage of participants||95% Confidence Interval|Number
842230|NCT00878709|Secondary|Central Nervous System Recurrence in Neratinib Arm Compared to Placebo Arm|CNS recurrence is defined as the time from randomization to CNS as the first distant recurrence. Competing events include distant recurrence at other sites as the first distant recurrence and death from any cause prior to distant recurrence.|From randomization until time of event up to 2 years|Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment.||percentage of participants with events|||Number
842231|NCT00878709|Secondary|Kaplan-Meier Estimates of Time to Distant Recurrence (TTDR) Survival at Year 2 by Treatment Arms||From randomization until time of event up to 2 years|Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment.||percentage of participants||95% Confidence Interval|Number
842232|NCT00878709|Secondary|Time to Distant Recurrence (TTDR) in Neratinib Arm Compared to Placebo Arm|Time to distant recurrence is defined as the time from date of randomization until the first occurrence of distant recurrence or death from breast cancer.|From randomization until time of event up to 2 years|Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment.||percentage of participants with events|||Number
842233|NCT00878709|Secondary|Kaplan-Meier Estimates of Distant Disease-free Survival (DDFS) at Year 2 by Treatment Arms||From randomization until time of event up to 2 years|Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment.||percentage of participants||95% Confidence Interval|Number
842234|NCT00878709|Secondary|Distant Disease-free Survival (DDFS) in Neratinib Arm Compared to Placebo Arm|Distant disease-free survival time is defined as the time from date of randomization until the first occurrence of distant recurrence or death from any cause.|From randomization until time of event up to 2 years|Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment.||percentage of participants with events|||Number
842235|NCT00878709|Secondary|Kaplan-Meier Estimates of Disease-free Survival Including Ductal Carcinoma in Situ (DFS-DCIS) at Year 2 by Treatment Arms||From randomization until time of event up to 2 years|Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment.||percentage of participants||95% Confidence Interval|Number
842236|NCT00878709|Secondary|Disease-free Survival Including Ductal Carcinoma in Situ (DFS-DCIS) in Neratinib Arm Compared to Placebo Arm|Disease-free survival including DCIS time is defined as the time from date of randomization until the first occurrence of DCIS or an iDFS event (an iDFS event including invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, or distant recurrence and death from any.|From randomization until time of event up to 2 years|Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment.||percentage of participants with events|||Number
842239|NCT00878709|Primary|Invasive Disease-free Survival (iDFS) in Neratinib Arm Compared to Placebo Arm|Invasive disease-free survival time is defined as the time from date of randomization until the first disease recurrence of the following events: invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, distant recurrence and death from any cause.|From randomization until time of event up to 2 years|Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment.||percentage of participants with events|||Number
842243|NCT00848744|Secondary|The Subject's Medication Side Effect Profile Will be Assessed Using a Application Site Scale for Dryness, Scaling, Redness, and Stinging/Burning.||4 Weeks||||||
842244|NCT00848744|Primary|Physician Global Assessment|Difference in physician global assessment between two formulations. We remain blinded as to which formulation, both containing salicylic acid, worked better on patients. Measure is a scale (not an option below). Best was 0 (clear), worst was 4 (severe).|28 days; The visits include baseline, Day 2, Day 7 (+/- 1) and Day 28 (+/- 3).|Analysis was per protocol. Each subject received formulations A and B randomized to opposite sides of the face.||units on a scale||Standard Deviation|Mean
842245|NCT00842153|Secondary|Mean Percent Change From Baseline to Week 4 in Percent (%) of Body Surface Area (BSA) Affected|Percent change from Baseline was calculated as the value at Week 4 minus the value at Baseline (Week 0) divided by the Baseline (Week 0) value * 100. Data for this outcome measure were not collected; thus, no data were analyzed.|Baseline (Week 0) and Week 4|ITT Population|||||
842246|NCT00842153|Secondary|Mean Percent Change From Baseline to Week 4 in Pruritus (Target Lesion)|Participants assessed their level of pruritus (itching) for the target lesion using a 10 centimeter (cm) Visual Analogue Scale (VAS) with the left side anchored with “0=None” and the right side anchored with “10=Very Severe.” A target lesion (>2 cm squared [cm^2]) was considered to be one on the trunk or extremities (excluding palms/soles, elbows, or knees). Percent change from Baseline was calculated as the value at Week 4 minus the value at Baseline (Week 0) divided by the Baseline (Week 0) value * 100.|Baseline (Week 0) and Week 4|ITT Population. Participants who returned for the visit specified (Week 4) and/or provided an assessment for pruritus were evaluated; not all participants returned for every study visit.||Percent change in scores on a scale||Standard Deviation|Mean
842247|NCT00842153|Secondary|Number of Participants With a Score of 0 or 1 for Subject Global Assessment at Baseline and Week 4|Participants assessed all treated areas using the Subject Global Assessment scale: 0=skin completely clear, possible residual hyperpigmentation; 1=psoriasis almost clear, patchy remnants of fine scaling present; 2=psoriasis mild, with small amount of psoriasis remaining (i.e., fine to coarse scales in some areas, definite redness, barely visible plaque thickness); 3=psoriasis moderate, between slight and definitely noticeable; 4=psoriasis very noticeable with redness, scaling, plaque thickness; 5=psoriasis severe with severe redness, thick scaling, and plaques.|Baseline (Week 0) and Week 4|ITT Population. Participants who returned for the visit specified (Week 4) and/or provided an assessment for Subject Global Assessment were evaluated; not all participants returned for every study visit.||participants|||Number
842248|NCT00842153|Secondary|Number of Participants With a Plaque Thickness Score of 0 or 1 at Baseline and Week 4|The investigator individually graded the severity of plaque thickness in participants as: 0=no elevation over normal skin; 1=possible but difficult to ascertain whether there is a slight elevation above normal skin; 2=slight but definite elevation, typically edges are indistinct or sloped; 3=moderate elevation with rough or sloped edges; 4=marked elevation typically with hard or sharp edges; and 5=very marked elevation typically with hard, sharp edges.|Baseline (Week 0) and Week 4|ITT Population. Participants who returned for the visit specified (Week 4) and/or provided an assessment for plaque thickness were evaluated; not all participants returned for every study visit.||participants|||Number
842249|NCT00842153|Secondary|Number of Participants With a Scaling Score of 0 or 1 at Baseline and Week 4|The investigator individually graded the severity of scaling in participants as: 0=no scaling; 1=no evidence of scaling; 2=minimal, occasional fine scale over less than 5% of the lesion; 3=mild, fine scales predominate; 4=moderate, coarse scales predominate; and 5=marked, thick nontenacious scales predominate.|Baseline (Week 0) and Week 4|ITT Population. Participants who returned for the visit specified (Week 4) and/or provided an assessment for scaling were evaluated; not all participants returned for every study visit.||participants|||Number
842250|NCT00842153|Secondary|Number of Participants With an Erythema Score of 0 or 1 at Baseline and Week 4|The investigator individually graded the severity of erythema (redness of skin) in participants as: 0=hyperpigmentation, pigmented macules (flat, distinct, colored area of skin), diffuse faint pink or red coloration; 1=no evidence of erythema, hyperpigmentation present; 2=faint erythema; 3=light red coloration; 4=moderate red coloration; and 5=bright red coloration.|Baseline (Week 0) and Week 4|ITT Population. Participants who returned for the visit specified (Week 4) and/or provided an assessment for erythema were evaluated; not all participants returned for every study visit.||participants|||Number
842251|NCT00842153|Secondary|Number of Participants With a Pruritus (Overall) Score of 0 or 1 at Baseline and Week 4|Participants assessed their level of pruritus (itching) over the previous 24-hour period using the following scale: 0=no itching; 1=minimal, very rarely aware of localized itching, present when relaxing and lasted for very short time; 2=mild, aware of itching at times, present when relaxing, not present when focused on other activities; 3=moderate, often aware of itching, annoying, sometimes disturbed sleep and daytime activities; and 4=severe, constant itching, distressing, frequent sleep disturbance, interfered with activities.|Baseline (Week 0) and Week 4|ITT Population Participants who returned for the visit specified (Week 4) and/or provided an assessment for pruritus were evaluated; not all participants returned for every study visit.||participants|||Number
842252|NCT00842153|Secondary|Number of Participants With a TLGI Score of 0, 1, or 2 at Week 1 and Week 4|The investigator assessed the TLGI of participants relative to their initial Baseline condition based on a 7-point scale: 0=completely cleared, possible residual discoloration; 1=almost cleared, 90% improvement, very significant clearance with only traces of disease remaining; 2=marked improvement, approximately 75%, with some disease remaining; 3=moderate improvement, approximately 50%; 4=mild improvement, approximately 25%, significant disease remains; 5=no change, no detectable improvement; 6=excerbation, worsening of signs and symptoms of disease.|Week 1 and Week 4|ITT Population. Participants who returned for the visit specified (Week 1 and/or 4) and/or provided an assessment for pruritus were evaluated; not all participants returned for every study visit.||participants|||Number
842253|NCT00842153|Secondary|Mean Percent Change From Baseline to Week 2 in Percent (%) of Body Surface Area (BSA) Affected|Percent change from Baseline was calculated as the value at Week 2 minus the value at Baseline (Week 0) divided by the Baseline (Week 0) value * 100. Data for this outcome measure were not collected; thus, no data were analyzed.|Baseline (Week 0) and Week 2|ITT Population|||||
842254|NCT00842153|Secondary|Mean Percent Change From Baseline to Week 2 in Pruritus (Target Lesion)|Participants assessed their level of pruritus (itching) for the target lesion using a 10 centimeter (cm) Visual Analogue Scale (VAS) with the left side anchored with “0=None” and the right side anchored with “10=Very Severe.” A target lesion (>2 cm squared [cm^2]) was considered to be one on the trunk or extremities (excluding palms/soles, elbows, or knees). Percent change from Baseline was calculated as the value at Week 2 minus the value at Baseline (Week 0) divided by the Baseline (Week 0) value * 100.|Baseline (Week 0) and Week 2|ITT Population. Participants who returned for the visit specified (Week 2) and/or provided an assessment of pruritis were evaluated; not all participants returned for every study visit.||Percent change in scores on a scale||Standard Deviation|Mean
842255|NCT00842153|Secondary|Number of Participants With a Score of 0 or 1 for Subject Global Assessment at Week 2|Participants assessed all treated areas using the Subject Global Assessment scale: 0=skin completely clear, possible residual hyperpigmentation; 1=psoriasis almost clear, patchy remnants of fine scaling present; 2=psoriasis mild, with small amount of psoriasis remaining (i.e., fine to coarse scales in some areas, definite redness, barely visible plaque thickness); 3=psoriasis moderate, between slight and definitely noticeable; 4=psoriasis very noticeable with redness, scaling, plaque thickness; 5=psoriasis severe with severe redness, thick scaling, and plaques.|Week 2|ITT Population. Participants who returned for the visit specified (Week 2) were evaluated; not all participants returned for every study visit.||participants|||Number
842256|NCT00842153|Secondary|Number of Participants With a Plaque Thickness Score of 0 or 1 at Week 2|The investigator individually graded the severity of plaque thickness in participants as: 0=no elevation over normal skin; 1=possible but difficult to ascertain whether there is a slight elevation above normal skin; 2=slight but definite elevation, typically edges are indistinct or sloped; 3=moderate elevation with rough or sloped edges; 4=marked elevation typically with hard or sharp edges; and 5=very marked elevation typically with hard, sharp edges.|Week 2|ITT Population. Participants who returned for the visit specified (Week 2) were evaluated; not all participants returned for every study visit.||participants|||Number
842257|NCT00842153|Secondary|Number of Participants With a Scaling Score of 0 or 1 at Week 2|The investigator individually graded the severity of scaling in participants as: 0=no scaling; 1=no evidence of scaling; 2=minimal, occasional fine scale over less than 5% of the lesion; 3=mild, fine scales predominate; 4=moderate, coarse scales predominate; and 5=marked, thick nontenacious scales predominate.|Week 2|ITT Population. Participants who returned for the visit specified (Week 2) were evaluated; not all participants returned for every study visit.||participants|||Number
842258|NCT00842153|Secondary|Number of Participants With an Erythema Score of 0 or 1 at Week 2|The investigator individually graded the severity of erythema (redness of skin) in participants as: 0=hyperpigmentation, pigmented macules (flat, distinct, colored area of skin), diffuse faint pink or red coloration; 1=no evidence of erythema, hyperpigmentation present; 2=faint erythema; 3=light red coloration; 4=moderate red coloration; and 5=bright red coloration.|Week 2|ITT Population. Participants who returned for the visit specified (Week 2) were evaluated; not all participants returned for every study visit.||participants|||Number
842259|NCT00842153|Secondary|Number of Participants With a Pruritus (Overall) Score of 0 or 1 at Week 2|Participants assessed their level of pruritus (itching) over the previous 24-hour period using the following scale: 0=no itching; 1=minimal, very rarely aware of localized itching, present when relaxing and lasted for very short time; 2=mild, aware of itching at times, present when relaxing, not present when focused on other activities; 3=moderate, often aware of itching, annoying, sometimes disturbed sleep and daytime activities; and 4=severe, constant itching, distressing, frequent sleep disturbance, interfered with activities.|Week 2|ITT Population. Participants who returned for the visit specified (Week 2) were evaluated; not all participants returned for every study visit.||participants|||Number
842260|NCT00842153|Secondary|Number of Participants With a TLGI Score of 0, 1, 2, or 3 at Weeks 1, 2, and 4|The investigator assessed the TLGI of participants relative to their initial Baseline condition based on a 7-point scale: 0=completely cleared, possible residual discoloration; 1=almost cleared, 90% improvement, very significant clearance with only traces of disease remaining; 2=marked improvement, approximately 75%, with some disease remaining; 3=moderate improvement, approximately 50%; 4=mild improvement, approximately 25%, significant disease remains; 5=no change, no detectable improvement; 6=excerbation, worsening of signs and symptoms of disease.|Weeks 1, 2, and 4|ITT Population. Participants who returned for the visit specified (Week 1, 2, and/or 4) were evaluated; not all participants returned for every study visit.||participants|||Number
842261|NCT00842153|Primary|Number of Participants With a Target Lesion Global Improvement (TLGI) Score of 0, 1, or 2 at Weeks 1, 2, and 4|The investigator assessed the TLGI of participants relative to their initial Baseline condition based on a 7-point scale: 0=completely cleared, possible residual discoloration; 1=almost cleared, 90% improvement, very significant clearance with only traces of disease remaining; 2=marked improvement, approximately 75%, with some disease remaining; 3=moderate improvement, approximately 50%; 4=mild improvement, approximately 25%, significant disease remains; 5=no change, no detectable improvement; 6=excerbation, worsening of signs and symptoms of disease.|Weeks 1, 2, and 4|Intent-to-Treat (ITT) Population: all enrolled participants. Participants who returned for the visit specified (Week 1, 2, and/or 4) were evaluated; not all participants returned for every study visit.||participants|||Number
842262|NCT00833859|Secondary|Number of Participants With Overall Survival|We intended to track the number of participants with overall survival at the projected end of the study period. The study was terminated prematurely.|6 months per patient|Data for this study was not collected because the study was abandoned after two enrollments due to funding being cancelled.|||||
842263|NCT00833859|Secondary|Number of Participants With Objective Response|Investigators planned to prospectively evaluate the ability of serum CA19-9 response and positron-emission tomography (PET) / computed tomography(CT) response to predict pathologic treatment response to GTX-SBRT and to determine the correlation of standardized uptake value (SUV) uptake on PET to fiducial marker placement.|6 months per patient|Data for this study was not collected because the study was abandoned after two enrollments due to funding being cancelled.|||||
842264|NCT00833859|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs).|Investigators planned to review the occurrences of AEs and SAEs according severity by NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0, Acute GI toxicity by Radiation Therapy Oncology Group (RTOG) Gastrointestinal (GI) toxicity scale.|6 months per patient|Data for this study was not collected because the study was abandoned after two enrollments due to funding being cancelled.|||||
842265|NCT00833859|Primary|Number of Participants With Resectability|The intent was to have 33 Evaluable Participants and measure the number of surgical resections with negative margins, ie. R0 resection rate. The new treatment would be of interest if the resectability rate was at least 30%. R0 resections were to be scored as those resections in which the common bile duct margin, pancreatic resection margin, retroperitoneal margin were negative for tumor involvement.|6 months per patient|Data for this study was not collected because the study was abandoned after two enrollments due to funding being cancelled.|||||
842266|NCT00793611|Secondary|Patient Global Impression of Improvement|Outcome measure is only administered at follow-up and used following treatment in patients with urinary incontinence. Measure varies from 1 to 7 on a Likert scale. 1=very much better and 7=very much worse and 4=no change. Thus, lower numbers represent greater improvement.|6-12 weeks after study initiation (@ completion of intervention)|ITT||units on a scale||Standard Deviation|Mean
842267|NCT00793611|Secondary|Change in Voiding Frequency Based on Voiding Diary|change in mean number of voids per 24 hours. Each participant recorded voiding frequency every 24 hours for 3 days at baseline and follow-up. A mean number of voids for every patient over 24 hours was calculated at baseline and follow-up.|baseline and 6-12 weeks after study initiation|ITT change in mean number of voids/24 hours||number of voids per 24 hours||Standard Deviation|Mean
842268|NCT00793611|Primary|Change in Overactive Bladder Symptoms (Based on OABqSF)|Scale information; Score ranges for oab-qsf quality of life scores range from 13-78; 13=poor quality of life 78=good quality of life. We reported change scores, with larger negative numbers indicating greater improvement in quality of life scores.|baseline and approximately 6-12 weeks after study initiation|ITT||units on a scale||Standard Deviation|Mean
842269|NCT00720096|Secondary|Response Rate|Determine response rate of array directed chemotherapy (as defined as the proportion of patients achieving complete or partial responses with a predictive score >/= 0.5 for either chemotherapy). As well as evaluate the accuracy of the chemosensitivity profiles for differentiating doxorubicin and topotecan responsive cancers. Due to the limited sample size the interpretation is limited. Results data for this outcome is not posted.|1 year, 2 months|Small sample size prevented planned interpretation.|||||
842270|NCT00720096|Primary|Interpret Genomic Array|Number of patients with biopsiable tumor in sufficient quantity and quality that will result in an interpretable genomic array.|1 year, 2 months|All patients enrolled 4/4 had biopsiable tumor and sufficient quantity and quality.||Participants|||Number
842271|NCT00720096|Primary|Assess Feasibility|Number of patients meeting 3 week feasibility window which was set as the benchmark.|1 year, 2 months|Patients whose information for treatment was available within the 3 week feasibility window which was set as the benchmark.||Participants|||Number
842272|NCT00718328|Primary|Perihematomal Edema|Solitary patient lost to follow up (out of state)|Days 7 and 14|||Relative perihematomal edema||Standard Deviation|Mean
842273|NCT00703092|Secondary|Quantify Enrollment Strategies, Retention, Compliance, Participant Characteristics, and Data Collection Challenges.||10 months|This study was terminated early due to lack of enrollment. No assays were run so there is no data to report.|||||
842274|NCT00703092|Primary|Generate Preliminary Data on the Range of Outcome Measures at Baseline and After 6 Months of Fiber Supplementation in Terms of: Ovulation Rates, Insulin Sensitivity, Concentrations of Circulating Androgens and Satiety.||10 months|This study was terminated early due to lack of enrollment. No assays were run so there is no data to report.|||||
842285|NCT00676052|Secondary|Change From Baseline in Clinic Visit Trough FVC on Day 29|The trough FVC is defined as the mean of the FVC values obtained 23 and 24 hours after dosing on Day 28. The Baseline FVC is the mean of the two assessments made 30 minutes pre-dose and immediately pre-dose [time 0] on Day 1. Change from Baseline was calculated by subtracting the post-baseline assessment value from the Baseline value.|Baseline (pre-dose Day 1) and Day 29|ITT Population. Participants with analyzable data on the indicated time point have been presented.||Liter||Standard Error|Least Squares Mean
842286|NCT00676052|Secondary|Change From Baseline in Weighted Mean for 0 to 24 Hours Forced Vital Capacity (FVC) on Day 1 to 2 and 28 to 29|Weighted means serial FVC was derived by calculating the AUC, and then dividing by the time interval over which the AUC was calculated. Baseline was defined at pre-dose Day 1. The weighted mean change from Baseline is the weighted mean minus Baseline. The AUC was calculated using the trapezoidal rule. For all post-dose observations, actual times that the spirometry measurements were conducted was used for the calculation. Pre-dose observations were counted as 0 hr observations - that is they had their time set to the time of dosing. The pre-dose value used for the calculation of the AUC was the mean of the two pre-dose observations (-30 and 0 min for Day 1 or 28). If one of these observations was missing, the remaining single pre-dose observation was used.|Baseline (pre-dose Day 1) and Days 1 to 2, Days 28 to 29|ITT Population. Participants with analyzable data on the indicated time point have been presented.||Liter||Standard Error|Least Squares Mean
842287|NCT00676052|Secondary|Change From Baseline in Weighted Mean for 0 to 24 Hours Serial FEV1 on Day 1 to 2 and 28 to 29|Weighted means serial FEV1 was derived by calculating the area under curve (AUC), and then dividing by the time interval over which the AUC was calculated. Baseline was defined at pre-dose Day 1. The weighted mean change from Baseline is the weighted mean minus Baseline. The AUC was calculated using the trapezoidal rule. For all post-dose observations, actual times that the spirometry measurements were conducted was used for the calculation. Pre-dose observations were counted as 0 hr observations - that is they had their time set to the time of dosing. The pre-dose value used for the calculation of the AUC was the mean of the two pre-dose observations (-30 and 0 min for Day 1 or 28). If one of these observations was missing, the remaining single pre-dose observation was used.|Baseline (pre-dose Day 1) and Days 1 to 2, Days 28 to 29|ITT Population. Participants with analyzable data on the indicated time point have been presented.||Liter||Standard Error|Least Squares Mean
842288|NCT00676052|Primary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 29|The trough FEV1 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Day 28. The Baseline FEV1 is the mean of the two assessments made 30 minutes pre-dose and immediately pre-dose [time 0] on Day 1. Change from Baseline was calculated by subtracting the post-baseline assessment value from the Baseline value.|Baseline (pre-dose Day 1) and Day 29|ITT Population. Last observation carried forward (LOCF) data has been presented.||Liter||Standard Error|Least Squares Mean
842304|NCT00598806|Secondary|Disease-Free Interval|The number of months from randomization to histologically confirmed progression of the patient’s bladder tumor or death from any cause|2 years|Target Ta, G1-G2 Population: patients who had 4 or fewer tumors that were ≤ 3.5 cm each at the time of randomization and who had subsequent histological confirmation from the central pathology lab that the tumors resected at the time of randomization were Ta, Grade 1 or 2.||months||Standard Error|Mean
842300|NCT00619983|Primary|Visual Analog Scale for Pain|"The primary outcome measure is the visual analog scale (VAS) for pain, a 10 cm line upon which the subject marks their intensity of pain. The line is anchored on the left as No pain at all and on the right as The worst pain imaginable. The score is the number of millimeters from the left origin of the line. The primary outcome measure for each period was the average value of all assessments for that period (2 weeks of measures for baseline, 6 weeks of measures for test drug alone, 6 weeks of measures for test drug plus gabapentin, and 2 weeks of measures for gabapentin alone)."|Study completion (16 weeks)|As noted in patient flow, data are available for only 14 of 22 subjects due to failure of the electronic daily diaries used to assess pain during the study and to study discontinuation in some cases||units on a scale||Full Range|Median
842302|NCT00598806|Secondary|Overall Survival|The number of months from randomization to death from any cause.|2 years|Target Ta, G1-G2 Population: patients who had 4 or fewer tumors that were ≤ 3.5 cm each at the time of randomization and who had subsequent histological confirmation from the central pathology lab that the tumors resected at the time of randomization were Ta, Grade 1 or 2.||months||Standard Error|Mean
842303|NCT00598806|Secondary|Disease-Free Survival|The number of months from randomization to histologically confirmed recurrence of the patient’s bladder tumor or death from any cause|2 years|Target Ta, G1-G2 Population: patients who had 4 or fewer tumors that were ≤ 3.5 cm each at the time of randomization and who had subsequent histological confirmation from the central pathology lab that the tumors resected at the time of randomization were Ta, Grade 1 or 2.||months||Standard Error|Mean
842305|NCT00598806|Secondary|Number of Recurrences Per Patient|The number of histologically confirmed recurrences during the course of the study.|2 years|Target Ta, G1-G2 Population: patients who had 4 or fewer tumors that were ≤ 3.5 cm each at the time of randomization and who had subsequent histological confirmation from the central pathology lab that the tumors resected at the time of randomization were Ta, Grade 1 or 2.||times||Standard Deviation|Mean
842306|NCT00598806|Secondary|Time to Progression|The number of months from randomization to progression to either a higher stage or grade of the patient’s bladder tumor.|2 years|Target Ta, G1-G2 Population: patients who had 4 or fewer tumors that were ≤ 3.5 cm each at the time of randomization and who had subsequent histological confirmation from the central pathology lab that the tumors resected at the time of randomization were Ta, Grade 1 or 2.||months||Standard Error|Mean
842307|NCT00598806|Secondary|Progression Rate at 2 Years|The percentage of participants that progress to either a higher stage or grade from the histologically confirmed stage and grade at time of randomization.|2 years|Target Ta, G1-G2 Population: patients who had 4 or fewer tumors that were ≤ 3.5 cm each at the time of randomization and who had subsequent histological confirmation from the central pathology lab that the tumors resected at the time of randomization were Ta, Grade 1 or 2.||Participants|||Count of Participants
842308|NCT00598806|Secondary|Time to Recurrence|The number of months from randomization to histologically confirmed recurrence of the patient’s bladder tumor.|2 years|Target Ta, G1-G2 Population: patients who had 4 or fewer tumors that were ≤ 3.5 cm each at the time of randomization and who had subsequent histological confirmation from the central pathology lab that the tumors resected at the time of randomization were Ta, Grade 1 or 2.||months||Standard Error|Mean
842309|NCT00598806|Primary|Recurrence Rate at 2 Years|The percentage of participants with histologically confirmed recurrence of the bladder tumor at any time after randomization and on or before year 2.|2 years|Target Ta, G1-G2 Population: patients who had 4 or fewer tumors that were ≤ 3.5 cm each at the time of randomization and who had subsequent histological confirmation from the central pathology lab that the tumors resected at the time of randomization were Ta, Grade 1 or 2.||Participants|||Count of Participants
842310|NCT00575159|Secondary|The Metabolite to Parent AUC Ratio, AUCmetabolite/AUCparent Ratio for GSK279782 Over Period|Blood samples were collected on time points: Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period to obtain the metabolite to parent AUC ratio for GSK279782|Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period|Pharmacokinetic (PK) Parameter Population comprised of all participants for whom pharmacokinetic parameter estimates were derived during any treatment period||Ratio||Geometric Coefficient of Variation|Geometric Mean
842311|NCT00575159|Secondary|The Metabolite to Parent AUC Ratio, AUCmetabolite/AUCparent Ratio for GSK189074 Over Period|Blood samples were collected on time points: Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period to obtain the metabolite to parent AUC ratio for GSK189074|Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period|Safety Population||Ratio||Geometric Coefficient of Variation|Geometric Mean
842312|NCT00575159|Secondary|Oral Clearance (CL/F) Over Period|Oral clearance is a measure of the rate at which the drug is cleared from the body via metabolism. Blood samples were collected on time points: Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period|Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period|Safety Population||mL/min||Geometric Coefficient of Variation|Geometric Mean
842313|NCT00575159|Secondary|AUC From Time Zero to 4 Hours Post Dose, AUC(0-4) for GSK189074 Over Period|AUC(0-4) was defined as AUC from time zero to 4 hours post dose. Blood samples were collected on time points: Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period.|Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period|Safety Population||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
842314|NCT00575159|Secondary|Time to Maximum Observed Plasma Concentration (Tmax) and Terminal Half Life, (T1/2) of GSK189075 Over Period|Tmax was defined as the time to the maximum or “peak” concentration of a drug observed after multiple administration. T1/2 was defined as the time to when half of the total amount of a particular substance is eliminated from the body. Blood samples obtained during indicated time points. T1/2 was calculated as t1/2 = ln2/λz, with λz (the terminal elimination rate-constant) estimated from log-linear regression analysis of the terminal phase of the plasma concentration-time profile.Tmax and t1/2 values for GSK189075 were presented.|Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period|Safety Population. Only those participants available at specified time points were analyzed.||hour||Geometric Coefficient of Variation|Geometric Mean
842315|NCT00575159|Secondary|Maximum Observed Plasma Concentration (Cmax) of GSK189075 Over Period|Plasma samples for pharmacokinetic analysis were drawn at indicated time points of each treatment period. Cmax was defined as maximal measured plasma concentration over the time span specified. Values were reported as Geometric Means with respective Geometric Coefficient of Variation (% CV).|Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period|Safety Population||ng/mL||Geometric Coefficient of Variation|Geometric Mean
842316|NCT00575159|Secondary|Area Under the Plasma Concentration vs. Time Curve (AUC) From Time Zero (Time of Dosing) to the Last Time Point With Measurable Analyte Concentration, AUC(0-last), AUC From Time Zero to Infinite Time, AUC(0-inf) of GSK189075 Over Period|AUC(0-last) was defined as area under the plasma concentration vs. time curve from time zero (time of dosing) to the last time point with measurable analyte concentration and AUC(0-inf) was defined as area under the plasma concentration vs. time curve from time zero to infinite time. Blood samples were collected on time points: Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period.|Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period|Safety Population||hour*nanograms per milliliter (hr*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
842317|NCT00575159|Secondary|Mean Creatinine Clearance 0-24 H|Urine samples for calculating creatinine clearance were obtained over the intervals: 0-4h, 4-8h, 8-12h, 12-16h and 16-24h. Mean creatinine clearance over 0-24 H was presented.|Day 1 of each treatment period|Safety Population||mL/min||Standard Deviation|Mean
842319|NCT00575159|Secondary|Percent of Filtered Glucose in the Urine.|Filtered glucose in the urine was assessed at indicated time points and was presented as Percentage. The 0-12h and 0-24h amounts Percent of filtered glucose in the urine were calculated by adding the amounts collected during these time intervals.|Up to 24 hours post dose of each treatment period.|Safety Population||Percentage||Standard Deviation|Mean
842320|NCT00575159|Secondary|Urinary Glucose Excretion (UGE) for Timed Subintervals up to 24 Hours Post Dose (0-24 H)|UGE was assessed for timed subintervals up to 24h post-dose. Urine samples were collected at intervals: 0-4h, 4-8h, 8-12h, 12-16h and 16-24h on study days. The 0-24h amounts excreted in urine were calculated by adding the amounts collected during these time intervals.|Up to 24 hours post dose of each treatment period|Safety Population||mmol||Standard Deviation|Mean
842321|NCT00575159|Secondary|Incremental Adjusted Weighted Means of Plasma Glucose AUC(0-4) and AUC(0-10) on Day 1|AUC(0-10) was the plasma glucose weighted mean AUC for 0 to 10 h post-dosing and AUC(0-4) was the plasma glucose weighted mean AUC for 0 to 4 h post-dosing. Incremental Adjusted Weighted Means were presented.|Up to 24 hours post dose of each treatment period.|Safety Population||mmol/L||Standard Deviation|Mean
842322|NCT00575159|Primary|Mean of Derived Plasma Glucose Parameters|The plasma measurements at specified time points on Day 1 were collected. Derived plasma glucose parameters were presented.|Up to 24 hours post dose of each treatment period.|Safety Population.||mmol/L||Standard Deviation|Mean
842323|NCT00575159|Primary|Summary of Fluid Balance|On Day 1, fluid intake, urine volume and number of micturations were recorded over the intervals for each of the following dosing periods: 0-4h, 4-8h, 8-12h, 12-16h and 16-24h. From these measures, fluid balance was calculated over the 24-hour period. Fluid Balance=total fluid intake minus total urine volume. The 0-24h amounts of total Fluid Intake, total urine output, and fluid balance were calculated by adding the amounts collected during these time intervals.|Up to 24 hours post dose of each treatment period.|Safety Population.||Milliliters (mL)||Standard Deviation|Mean
842324|NCT00575159|Primary|Mean Creatinine Clearance|Creatinine clearance was calculated and reported in Milliliters per minute (mL/min) on Day 1 of each period for each collection interval 0-4, 4-8, 8-12, 12-16 and 16-24 hour, as well as the combined intervals of 0-12 and 0-24 hour. For urine measurements, participants were instructed to void within 30 minutes before administration of study medication.|Up to 24 hours post dose of each treatment period.|Safety Population. Only those participants available at the specified time points were analyzed.||mL/min||Standard Deviation|Mean
842325|NCT00575159|Primary|Summary of Urine Osmolality|Urine sample was collected at screening, Day –2 (18:00h) and Day 1 (7:45h) for determination of urine osmolality which was measured in Millimole per kilogram (mmol/kg).|Day 1 (pre dose) of each treatment period|Safety Population. Only those participants available at the specified time points were analyzed.||mmol/kg||Standard Deviation|Mean
842326|NCT00575159|Primary|Number of Participants With Abnormal Hematology Data|Data for abnormal Hematology parameters: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, Mean Corpuscle Hemoglobin (MCH), Mean Corpuscle Volume (MCV), Monocytes, Platelet count, Red Blood Cell (RBC), Reticulocytes, Total Neutrophils, White Blood Cell (WBC) were reported. Data for number of participants with abnormal Hematology were reported.|Day 1 of each treatment period|Safety Population. Only those participants available at the specific time points were analyzed.||Participants|||Count of Participants
842327|NCT00575159|Primary|Number of Participants With Abnormal Clinical Chemistry Data|Clinical Chemistry data for parameters: Alanine Amino Transferase (ALT), Albumin, Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Bicarbonate, Calcium, Chloride, Creatine Kinase, Creatinine, Gamma Glutamyl Transferase (GGT), Glucose, Lactate Dehydrogenase, Magnesium, Phosphorus, Potassium, Total Bilirubin, Sodium, Total protein, triglycerides and urea/BUN was reported. Data for number of participants with abnormal clinical Chemistry data was presented.|Day 1 of each treatment period|Safety Population. Only those participants available at the specific time points were analyzed.||Participants|||Count of Participants
842328|NCT00575159|Primary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings|Standard semi-recumbent 12-lead ECG was obtained after the participant rested for a minimum of 10 minutes (If questionable abnormality was noted on the ECG, 2 more measurements were allowed to provide an average of 3 measurements). Number of participants with abnormal ECG were reported.|Day 1 of each treatment period|Safety Population||Participants|||Count of Participants
842329|NCT00575159|Primary|Change From Baseline Vital Signs: Heart Rate|Heart rate was obtained during each treatment period at indicated time points. Measurements were made with the participants lying semi-recumbent having rested in this position for at least 10 minutes before the initial reading.|Day 1 of each treatment period|Safety Population||beats/minute||Standard Deviation|Mean
842330|NCT00575159|Primary|Change From Baseline Vital Signs: Systolic and Diastolic Blood Pressure (SBP and DBP)|SBP and DBP were obtained during each treatment period at the indicated time points. Measurements were made with the participant lying semi-recumbent having rested in this position for at least 10 minute before the initial reading.|Day 1 of each treatment period|Safety Population||Millimeters of mercury (mmHg)||Standard Deviation|Mean
842331|NCT00575159|Primary|Number of Participants With Hypoglycemia Episodes/Events|A hypoglycemic event was defined as symptoms of hypoglycemia confirmed by a blood glucose value below normal limits [less than 3.89 millimoles per liter (mmol/L)] or 70 milligrams per deciliter (mg/dL). Symptoms of hypoglycemia without confirmed blood glucose values were reported as AEs instead of hypoglycemic events. Number of participants with hypoglycemic events were reported.|Day 1 of each treatment period|Safety Population||Participants|||Count of Participants
842332|NCT00575159|Primary|Number of Participants With All Adverse Events (AE) and Serious Adverse Events (SAE)|Data for number of participants who presented one or more adverse events (serious or non serious) was reported. An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.|Up to 6 months|Safety Population comprised of all enrolled participants who have received at least one dose of study drug were included in the safety population.||Participants|||Count of Participants
842333|NCT00461591|Secondary|Overall Survival|The number of months from randomization to death from any cause.|2 years|Target Ta, G1-G2 Population: patients who had 4 or fewer tumors that were ≤ 3.5 cm each at the time of randomization and who had subsequent histological confirmation from the central pathology lab that the tumors resected at the time of randomization were Ta, Grade 1 or 2.||months||Standard Error|Mean
842334|NCT00461591|Secondary|Disease Free Survival|The number of months from randomization to histologically confirmed recurrence of the patient’s bladder tumor or death from any cause|2 years|Target Ta, G1-G2 Population: patients who had 4 or fewer tumors that were ≤ 3.5 cm each at the time of randomization and who had subsequent histological confirmation from the central pathology lab that the tumors resected at the time of randomization were Ta, Grade 1 or 2.||months||Standard Error|Mean
842335|NCT00461591|Secondary|Disease Free Interval|The number of months from randomization to histologically confirmed progression of the patient’s bladder tumor or death from any cause|2 years|Target Ta, G1-G2 Population: patients who had 4 or fewer tumors that were ≤ 3.5 cm each at the time of randomization and who had subsequent histological confirmation from the central pathology lab that the tumors resected at the time of randomization were Ta, Grade 1 or 2.||months||Standard Error|Mean
842336|NCT00461591|Secondary|Number of Recurrences Per Patient|The number of histologically confirmed recurrences during the course of the study.|2 years|Target Ta, G1-G2 Population: patients who had 4 or fewer tumors that were ≤ 3.5 cm each at the time of randomization and who had subsequent histological confirmation from the central pathology lab that the tumors resected at the time of randomization were Ta, Grade 1 or 2.||times||Standard Deviation|Mean
842337|NCT00461591|Secondary|Time to Progression|The number of months from randomization to progression to either a higher stage or grade of the patient’s bladder tumor.|2 years|Target Ta, G1-G2 Population: patients who had 4 or fewer tumors that were ≤ 3.5 cm each at the time of randomization and who had subsequent histological confirmation from the central pathology lab that the tumors resected at the time of randomization were Ta, Grade 1 or 2.||months||Standard Error|Mean
842338|NCT00461591|Secondary|Progression Rate at 2 Years|The percentage of participants that progress to either a higher stage or grade from the histologically confirmed stage and grade at time of randomization.|2 years|Target Ta, G1-G2 Population: patients who had 4 or fewer tumors that were ≤ 3.5 cm each at the time of randomization and who had subsequent histological confirmation from the central pathology lab that the tumors resected at the time of randomization were Ta, Grade 1 or 2.||Participants|||Count of Participants
842339|NCT00461591|Secondary|Time to Recurrence|The number of months from randomization to histologically confirmed recurrence of the patient’s bladder tumor.|2 years|Target Ta, G1-G2 Population: patients who had 4 or fewer tumors that were ≤ 3.5 cm each at the time of randomization and who had subsequent histological confirmation from the central pathology lab that the tumors resected at the time of randomization were Ta, Grade 1 or 2.||months||Standard Error|Mean
842340|NCT00461591|Primary|Recurrence Rate at 2 Years|The percentage of participants with histologically confirmed recurrence of the bladder tumor at any time after randomization and on or before year 2.|2 years|Target Ta, G1-G2 Population: patients who had 4 or fewer tumors that were ≤ 3.5 cm each at the time of randomization and who had subsequent histological confirmation from the central pathology lab that the tumors resected at the time of randomization were Ta, Grade 1 or 2.||Participants|||Count of Participants
842378|NCT03054077|Primary|Change in Anxiety Scores With the Addition of the iPad Intervention-Comparing Group 1 to Group 2|"The Modified Yale Preoperative Anxiety Scale- Short form (mYPAS-SF) Ratings produce 4 mYPAS scores (1 for each time point)
Areas scored:
Activity (1,2,3, or 4) Vocalizations (1,2,3,4,5,or 6) Emotional Expressivity (1,2,3, or 4) State of Apparent arousal (1,2,3, or 4) Scoring: Each score is calculated by dividing each item rating by the highest possible rating (i.e., 6 for the “vocalizations” item and 4 for all other items), adding all the produced values, dividing by 5, and multiplying by 100.
This calculation produces a score ranging from 23.33 to 100, with higher values indicating higher anxiety.
Comparison of scores between Group 1 and Group 2 to see if changes in anxiety scores occurred with the addition of the iPad.
All data will be gathered with review at the close of the study which is anticipated to occur in 5/20/2017."|Immediately following enrollment, immediately before anesthesia, and post-op assessed up to 10 minutes|All participants for whom 3 time points were collected at Baseline T1, T2, and T3||units on a scale||95% Confidence Interval|Least Squares Mean
842379|NCT02786927|Secondary|Percentage of Participants Preferring the Inhaler Based on the Size of the Inhaler|Preference between ELLIPTA inhaler and HandiHaler based on the size of the inhaler was assessed by the inhaler preference questionnaire at Visit 3 or EW visit. The responses were analyzed using a Cochran-Mantel-Haenszel test, adjusted for study inhaler use sequence and preference questionnaire version.|Up to 18 days|Modified ITT Population||Percentage of participants|||Number
842380|NCT02786927|Secondary|Percentage of Participants Preferring the Inhaler Based on How Easy it Was to Tell How Many Doses Were Left|Preference between ELLIPTA inhaler and Handihaler based on how easy it was to tell how many doses were left was assessed by the inhaler preference questionnaire at Visit 3 or EW visit. The responses were analyzed using a Cochran-Mantel-Haenszel test, adjusted for study inhaler use sequence and preference questionnaire version.|Up to 18 days|Modified ITT Population||Percentage of participants|||Number
842381|NCT02786927|Primary|Percentage of Participants Preferring the Inhaler Based on the Number of Steps Needed to Take the COPD Medication|Preference between ELLIPTA inhaler and Handihaler based on the number of steps needed to take the medication was assessed by the inhaler preference questionnaire at Visit 3 or Early Withdrawal (EW) visit. The responses were analyzed using a Cochran-Mantel-Haenszel test, adjusted for study inhaler use sequence and preference questionnaire version. The analysis was performed on the Modified Intent-to-treat (ITT) Population comprised of all participants in the ITT Population (comprised all randomized participants who received 1 dose of at least 1 study inhaler) who completed at least one question from the 5 preference questions.|Up to 18 days|Modified ITT Population||Percentage of participants|||Number
842382|NCT02736175|Primary|Absence of Ocular Pain|Absence of pain (i.e., score of ‘0’) in the study eye at Day 8|Day 8|ITT LOCF (last observation carried forward)||percentage of total participants|||Number
842383|NCT02736175|Primary|Absence of Anterior Chamber Inflammation|Absence of cells (i.e., score of ‘0’) in the anterior chamber of the study eye at Day 14|Day 14|ITT LOCF (last observation carried forward)||percentage of total participants|||Number
842384|NCT02686437|Primary|Penn Shoulder Score (PENN)|The PENN is a outcome measure designed to determine the amount of disability patients are experiencing doing day to day activities. The total score is out of 100, 100 being no disability and 0 being completely disabled.|4 weeks|||units on a scale||Standard Error|Mean
842385|NCT02686437|Primary|Numeric Pain Rating Scale (NPRS)|Rate the pain on a scale of 0 to 10, 0 being none and 10 being the worst imaginable pain|4 weeks|||units on a scale||Standard Error|Mean
842386|NCT02681510|Secondary|Number of Participants Who Reported Quitting at the End of Treatment|Self-reported Quit Rate at End of Treatment (12 Weeks); assessed as no smoking in the 7 days prior to the Week 12 follow-up call|Week 12|All study participants (N=36)||Participants|||Count of Participants
842387|NCT02681510|Secondary|Participant Satisfaction With Medications' Ability to Help Participant Quit Smoking|Participant Satisfaction with Medications' Ability to Help Participant Quit Smoking assessed on a 1-10 Likert Scale (higher value=greater satisfaction)|Week 12|All study participants (N=36)||units on a scale||Standard Deviation|Mean
842388|NCT02681510|Secondary|Participant Satisfaction With Medications' Ability to Control Withdrawal Symptoms|Satisfaction with Medications' Ability to Control Withdrawal Symptoms assessed on a 1-10 Likert Scale (higher value=greater satisfaction)|Week 12|||units on a scale||Standard Deviation|Mean
842390|NCT02667821|Other Pre-specified|Changes in Blood Flow Through Vertebral Artery|Phase contrast MRI provides velocity measurements that can be used for analysis of the blood flow and tissue motion. At the level of C1-2, the contralateral and ipsilateral vertebral arteries (VA), defined to the direction of head motion, were assessed and anatomical images were established to localize the VA circulation. Mean and SDs were calculated for VA blood flow (mL/s) for each of the head conditions and VA side. Differences between task maneuvers and VA flow and velocity were evaluated using a repeated-measures analysis of variance with factors of head position and VA side, and a level of significance was set at .05|The series of fMRI sequences will be performed on each participant immediately after each procedure.|||mL/s||Standard Deviation|Mean
842391|NCT02667821|Secondary|Changes in Tissue Perfusion in the Posterior Cerebrum and Cerebellum Will be Assessed Using Arterial Spin Labeling (ASL) MRI Technique.|ASL allows one to separate the blood flow from the BOLD effect, thus giving clear measures of perfusion. More specifically ASL will be used to measure blood perfusion and allow extraction of metabolic difference from flow differences in BOLD imaging. It is a quantitative technique, yielding values with units of ml/(100g of tissue)·min-1.|The series of ASL sequences will be performed on each participant immediately after each condition. Through study completion, data will be presented after an average of 1 year.|||ml/100g of tissue/minute||Standard Deviation|Mean
842392|NCT02667821|Primary|Changes in Blood Flow Through the Vertebral Artery and Posterior Cerebral and Cerebellar Circulation|Phase contrast MRI provides velocity measurements that can be used for analysis of the blood flow and tissue motion. At the level of C1-2, the contralateral and ipsilateral vertebral arteries (VA), defined to the direction of head motion, were assessed and anatomical images were established to localize the VA circulation. Mean and SDs were calculated for VA blood velocity (cm/s) for each of the head conditions and VA side. Differences between task maneuvers and VA flow and velocity were evaluated using a repeated-measures analysis of variance with factors of head position and VA side, and a level of significance was set at .05|The series of fMRI sequences will be performed on each participant immediately after each condition. Through study completion, data will be presented after an average of 1 year.|||cm/s||Standard Deviation|Mean
842393|NCT02586506|Secondary|The Percentage of Participants Who Demonstrated Correct Use of the ELLIPTA Inhaler at the End of the Study|Participants’ ability to correctly use the ELLIPTA inhaler was assessed at Visit 2 using the Correct Use Checklist by an ELLIPTA trained health care professional. The percentage was reported overall for the single treatment group along with a 95% CI for the percentage calculated using the exact binomial distribution.|Day 28|mITT Population||Percentage||95% Confidence Interval|Number
842394|NCT02586506|Secondary|The Percentage of Participants Who Rated the Ability to Tell How Many Doses Were Remaining in the ELLIPTA Inhaler as Easy or Very Easy at the End of the Study|Participants rated how easy it was to determine how many doses were left in the ELLIPTA inhaler, using a four-point Likert scale (1-very easy, 2-easy, 3-difficult, 4-very difficult). “Easy to use” was defined as the combination of an “easy” or “very easy” rating choice. The percentage was reported overall for the single treatment group along with a 95% CI for the percentage calculated using the exact binomial distribution.|Day 28|mITT Population||Percentage||95% Confidence Interval|Number
842395|NCT02586506|Primary|The Percentage of Participants With Asthma Who Rated the Use of the ELLIPTA Inhaler as Easy or Very Easy, Among Those Who Demonstrated Correct Use of the Inhaler at the End of the Study.|Participants rated how easy it was to use the ELLIPTA inhaler, using a four-point Likert scale (1-very easy, 2-easy, 3-difficult, 4-very difficult). “Easy to use” was defined as the combination of an “easy” or “very easy” rating choice. The percentage was reported overall for the single treatment group along with a 95% confidence interval (CI) for the percentage calculated using the exact binomial distribution.|Day 28|Modified Intent-to-Treat (mITT) Population: all participants who were screened and received at least one dose of study treatment (placebo) and were randomised to receive the ELLIPTA inhaler ease of use questionnaire version A or B at Visit 2.||Percentage||95% Confidence Interval|Number
842396|NCT02570126|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed included medical occurrences that resulted in death, were life threatening, required hospitalisation or prolongation of hospitalisation or resulted in disability/incapacity. Any SAE = occurrence of SAE regardless of intensity grade or relation to vaccination|From Day 0 through the end of study (Day 84)|||Subjects|||Number
842397|NCT02570126|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination|43-day post vaccination period following Dose 1 (Day 0) and Dose 2 (Day 42)|Analysis was performed on the Total Vaccinated cohort. Number of participants analysed corresponds to the subjects in the Total Vaccinated cohort with the administered dose 43 days following each vaccination and across doses for each of the 2 groups (VAR_HSA_F Group and VAR Group)||Subjects|||Number
842398|NCT02570126|Secondary|Number of Subjects Reporting Febrile Convulsions|Any febrile convulsion = occurrence of the specified solicited general symptom regardless of its intensity. Grade 3 febrile convulsion = febrile convulsion which prevented normal, everyday activities. Related febrile convulsion = assessed by the investigator as causally related to study vaccination|43-day post vaccination period following Dose 1 (Day 0) and Dose 2 (Day 42)|Analysis was performed on the Total Vaccinated cohort. Number of participants analysed corresponds to the subjects in the Total Vaccinated cohort with at least one documented dose 43 days following each vaccination and across doses for each of the 2 groups (VAR_HSA_F Group and VAR Group)||Subjects|||Number
842399|NCT02570126|Secondary|Number of Subjects Reporting Rash|Any rash = occurrence of the specified solicited general symptom regardless of its intensity. Grade 3 rash = rash which prevented normal, everyday activities. Related rash = assessed by the investigator as causally related to study vaccination|43-day post vaccination period following Dose 1 (Day 0) and Dose 2 (Day 42)|Analysis was performed on the Total Vaccinated cohort. Number of participants analysed corresponds to the subjects in the Total Vaccinated cohort with at least one documented dose 43 days following each vaccination and across doses for each of the 2 groups (VAR_HSA_F Group and VAR Group)||Subjects|||Number
842400|NCT02570126|Secondary|Number of Subjects Reporting Fever|Any fever (≥ 38°C) = occurrence of any fever regardless of its intensity grade or relationship to vaccination. Grade 3 fever = temperature > 39.5°C. Related fever = assessed by the investigator as causally related to study vaccination|43-day post vaccination period following Dose 1 (Day 0) and Dose 2 (Day 42)|Analysis was performed on the Total Vaccinated cohort. Number of participants analysed corresponds to the subjects in the Total Vaccinated cohort with the documented dose 43 days following each vaccination and across doses for each of the 2 groups (VAR_HSA_F Group and VAR Group)||Subjects|||Number
842401|NCT02570126|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed were pain, injection site redness and swelling. Any = occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain = subject crying when limb was moved or as spontaneously painful. Grade 3 redness and swelling = above (>) 20 mm|4-day post vaccination period following Dose 1 (Day 0) and Dose 2 (Day 42)|Analysis was performed on the Total Vaccinated cohort. Number of participants analysed corresponds to the subjects in the Total Vaccinated cohort with at least one documented dose 4 days following each vaccination and across doses for each of the 2 groups (VAR_HSA_F Group and VAR Group)||Subjects|||Number
842402|NCT02570126|Secondary|Number of Subjects With a Seroresponse to VZV (Immuno Sub Cohort)|For VZV, seroresponse was defined as, post-vaccination anti-VZV antibody concentration ≥ 50 mIU/mL among subjects who were seronegative (antibody concentration below (< ) 25 mIU/mL) before vaccination|At Day 42 and Day 84 post vaccination|Immunogenicity analyses were performed on the According-to-protocol (ATP) cohort for immunogenicity. Seropositivity was assessed in sub cohort of the ATP cohort for immunogenicity for each group (immuno sub cohort) who had blood taken and tested for anti-varicella antibodies at Day 0, Day 42, and Day 84||Subjects|||Number
842403|NCT02570126|Secondary|Evaluation of Immune Response to Varicella Vaccine With Respect to Anti Varicella Zoster Virus (Anti-VZV) Antibody Concentrations (Immuno-sub Cohort)|Anti-VZY antibody concentrations were expressed in terms of Geometric Mean Concentrations (GMCs)|At Day 42 and Day 84 post vaccination|Immunogenicity analyses were performed on the According-to-protocol (ATP) cohort for immunogenicity. Immune response (in terms of GMC) was assessed in sub cohort of the ATP cohort for immunogenicity for each group (immuno sub cohort) who had blood taken and tested for anti-varicella antibodies at Day 0, Day 42, and Day 84||mIU/mL||95% Confidence Interval|Geometric Mean
842404|NCT02570126|Secondary|Number of Subjects Reporting Fever|Fever was defined as axillary temperature greater than or equal to (≥) 38.0°C (≥ 100.4°F)|15 days post each dose of varicella vaccination|Analysis was performed on the Total Vaccinated cohort. Number of participants analysed corresponds to the subjects in the Total Vaccinated cohort with documented dose 15-days post each dose of varicella vaccination for each of the 2 groups (VAR_HSA_F Group and VAR Group)||Subjects|||Number
842405|NCT02570126|Primary|Number of Subjects Reporting Fever|Fever was defined as axillary temperature above (>) 39.0 °C (> 102.2°F)|15-days (Days 0-14) post Dose 1 of varicella vaccination|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects with administration of either Varilrix HSA-free or Varilrix™vaccine documented. Number of participants analysed corresponds to the subjects in the Total Vaccinated cohort with documented dose 15-days (Days 0-14) post Dose 1 of varicella vaccination||Subjects|||Number
842406|NCT02401256|Primary|Efavirenz AUC0-inf (Single Dose) and AUC0-24(Multiple Dose)|After the samples collection, blood from phase 2 and phase 4 were used to perform the quantification of Efavirenz in plasma. The composite of the efavirenz concentration (blood collection between 0 to 120 hrs) were used to calculate the area under the plasma concentration time curve (AUC0-inf for single dose and AUC0-24 for multiple dose) of efavirenz.|Single dose pharmacokinetics (PK) versus multiple doses (after 17 day pretreatment) PK (total 38 days for each subject)|Just volunteers with Efavirenz quantification information (complete or partial) and CYP2B6 genotype were included in this data analysis (Total of 61)||h*uM||Standard Deviation|Mean
842407|NCT02387996|Secondary|ORR Per Investigator by PD-L1 Expression Level|Investigator-assessed ORR was defined as the number of subjects with a best overall response of confirmed CR or PR divided by the number of all treated subjects. PD-L1 expression level = Membranous staining in greater than or equal to 5% and greater than or equal to 1% tumor cells. n = Number of participants in each category|from the date of first dose to the date of objectively documented progression or the date of subsequent therapy, whichever occurs first (assessed up to 14 months)|All treated participants. Treated participants from Japan enrolled after main enrollment period were excluded from primary efficacy analysis.||Percent of Participants||95% Confidence Interval|Number
842408|NCT02387996|Secondary|Objective Response Rate (ORR) Per Investigator|Investigator-assessed ORR was defined as the number of subjects with a best overall response of confirmed CR or PR divided by the number of all treated subjects.|from the date of first dose to the date of objectively documented progression or the date of subsequent therapy, whichever occurs first (assessed up to 14 months)|All treated participants. Treated participants from Japan enrolled after main enrollment period were excluded from primary efficacy analysis.||Percent of Participants||95% Confidence Interval|Number
842409|NCT02387996|Secondary|OS by PD-L1 Expression Level|Overall Survival was defined as the time from first dosing date to the date of death. A subject who had not died was censored at last known date alive. PD-L1 expression level = membranous staining in greater than or equal to 5% and greater than or equal to 1% tumor cells. n = Number of participants in each category|From first dosing date to the date of death (approximately 14 months)|All treated participants. Treated participants from Japan enrolled after main enrollment period were excluded from primary efficacy analysis.||Months||95% Confidence Interval|Median
842410|NCT02387996|Secondary|Overall Survival|Overall Survival was defined as the time from first dosing date to the date of death. A subject who had not died was censored at last known date alive.|From first dosing date to the date of death (assessed up to 14 months)|All treated participants. Treated participants from Japan enrolled after main enrollment period were excluded from primary efficacy analysis.||months||95% Confidence Interval|Median
842411|NCT02387996|Secondary|PFS Per BIRC Assessment by PD-L1 Expression Level|PFS was defined as the time from first dosing date to the date of the first documented tumor progression, based on BIRC assessments (per RECIST 1.1), or death due to any cause. RECIST is the Response Evaluation Criteria in Solid Tumors PD-L1 expression level is defined as membranous staining in greater than or equal to 5% and greater than or equal to 1% tumor cells. n = Number of participants in each category|from first dosing date to the date of the first documented tumor progression (assessed up to 14 months)|All treated participants. Treated participants from Japan enrolled after main enrollment period were excluded from primary efficacy analysis.||months||95% Confidence Interval|Median
842412|NCT02387996|Secondary|Progression-Free Survival (PFS) Per BIRC Assessment|PFS was defined as the time from first dosing date to the date of the first documented tumor progression, based on BIRC assessments (per RECIST 1.1), or death due to any cause. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. RECIST = Response Evaluation Criteria in Solid Tumors|from first dosing date to the date of the first documented tumor progression (assessed up to 14 months)|All treated participants. Treated participants from Japan enrolled after main enrollment period were excluded from primary efficacy analysis.||Months||95% Confidence Interval|Median
842413|NCT02387996|Primary|ORR Per BIRC Assessment by PD-L1 Expression Level|Objective Response Rate (ORR) was defined as the number of participants with a best overall response of confirmed Complete Response (CR) or Partial Response (PR) (per RECIST 1.1 criteria) divided by the number of all treated participants. RECIST 1.1 = Response Evaluation Criteria in Solid Tumors. CR= Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. BIRC= blinded independent review committee PD-L1 expression level= membranous staining in greater than or equal to 5% and greater than or equal to 1% tumor cells. n = Number of participants in each category|From the date of first dose to the date of objectively documented progression or the date of subsequent therapy, whichever occurs first (assessed up to 14 months)|All treated participants. Treated participants from Japan enrolled after main enrollment period were excluded from primary efficacy analysis.||Percent of Participants||95% Confidence Interval|Number
842414|NCT02387996|Primary|Objective Response Rate Per BIRC Assessment|Objective Response Rate (ORR) was defined as the number of participants with a best overall response of confirmed Complete Response (CR) or Partial Response (PR) (per RECIST 1.1 criteria) divided by the number of all treated participants. RECIST 1.1 = Response Evaluation Criteria in Solid Tumors. CR= Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. BIRC= blinded independent review committee|From the date of first dose to the date of objectively documented progression or the date of subsequent therapy, whichever occurs first (assessed up to 14 months)|All treated participants. Treated participants from Japan enrolled after main enrollment period were excluded from primary efficacy analysis.||Percent of participants||95% Confidence Interval|Number
842415|NCT02387749|Secondary|Change of Levels of Glycated Haemoglobin( HA1C) After Stem Cells Transfusion Measured in Percent %|Blood tests before and after stem cells(90 days) transfusion and comparing the values in percent % which is reflecting the patient blood sugar control in the previous 3 months|at base line (zero day) and 90 days after stem cells transfusion|||percent %||Standard Deviation|Mean
842416|NCT02387749|Secondary|Change of Levels of Fasting Blood Sugar and 2 Hours Post Prandial at Base Line ( Zero Day ) and After (90 Days) After Stem Cells Transfusion|fasting, 2 hours postprandial blood sugar measurement before at base line (zero day) and after (90 days) stem cells transfusion as a follow up and comparing the values.|base line (zero day) and 90 days after stem cells transfusion|||mg/dl||Standard Deviation|Mean
842417|NCT02387749|Primary|Change of Nerve Conduction Amplitude of Nerves Affected Measured by Nerve Conduction Study.|"Measuring nerve conduction amplitudes in uv of upper and lower limbs nerves(sensory and motor).
lower limb nerves : tibial , common peroneal(CP) as motor and sural nerve as sensory .
upper limb nerves: ulnar nerve as motor and sensory. and compare at base line and 90 days after stem cells transfusion"|base line(zero dya), 90 days after stem cells transfusion|||uv||Standard Deviation|Mean
842418|NCT02387749|Primary|Change of Nerve Conduction Latency of Nerves Affected Measured by Nerve Conduction Study|Measuring nerve conduction latency in msec of upper and lower limbs nerves(sensory and motor) lower limb nerves : tibial , common peroneal(CP) as motor and sural nerve as sensory upper limb nerves: ulnar nerve as motor and sensory and compare at base line and 90 days after stem cells transfusion|base line(zero dya), 90 days after stem cells transfusion .|||msec||Standard Deviation|Mean
842419|NCT02387749|Primary|Change of Nerve Conduction Velocities of Nerves Affected Measured by Nerve Conduction Study.|Measuring nerve conduction velocities(NCV) in m/sec upper and lower limbs nerves(sensory and motor) lower limb nerves : tibial , common peroneal(CP) as motor and sural nerve as sensory upper limb nerves: ulnar nerve as motor and sensory and compare at base line(zero day) and 90 days after stem cells transfusion|base line(zero dya), 90 days after stem cells transfusion.|||m/sec||Standard Deviation|Mean
842420|NCT02387749|Primary|Measurement of b-FGF, v-EGF MEASURED BY ELISA|measurement of b-FGF and v-EGF MEASURED BY ELISA before (at zero), and after at (7 days, 90) days after stem cell transfusion to measure the effect of stem cell and its role in nerve regeneration|zero ( before) , 7 DAYS, 90 days|b-FGF, V-EGF (pg/ml) measured at zero, 7 days after stem cell transfusion measured by ELISA to measure the effectiveness of stem cells and as an indication for nerve regeneration||pg/ml||Standard Deviation|Mean
842437|NCT02275052|Secondary|Change From Baseline in Inspiratory Capacity (IC) 3 Hours Post-dose at Week 12 of Each Treatment Period|IC is defined as the maximum amount of air that can be inhaled into the lungs from the normal resting position after breathing out normally. Standard body plethysmography techniques were used for lung volumes. Baseline is the IC value recorded pre-dose on Day 1 of each treatment period. Mean Baseline is the mean of the Baselines for each par. Period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each par. IC 3-hours post-dose was measured from the value obtained 3 hours after dosing on Day 2 and Week 12. Analysis performed using a repeated measures model with covariates of period Baseline, mean Baseline, period, treatment, visit (Day 2 or Week 12), smoking status, visit by period Baseline, visit by mean Baseline and visit by treatment interactions.|Baseline and at Week 12 of each treatment period (up to Week 30)|ITT Population including off-treatment data. Number of par. represent those with data available at the time point; however, all par. in the ITT population without missing covariate information and with at least one post Baseline measurement are included.||Liters||Standard Error|Least Squares Mean
842438|NCT02275052|Secondary|Change From Baseline in Functional Residual Capacity (FRC) 3 Hours Post-dose at Week 12 of Each Treatment Period|FRC is defined as the amount of air still left in the lungs after breathing out normally. Standard body plethysmography techniques were used for lung volumes. Baseline is the assessment recorded before dosing on Day 1 of each period. Mean Baseline is the mean of the Baselines for each participant. Period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. FRC 3 hours post-dose was measured from the value obtained 3 hours after dosing on Day 2 and Week 12. Analysis was performed using a repeated measures model and the following covariates were included: period Baseline, mean Baseline, period, treatment, visit, smoking status, visit by period Baseline, visit by mean Baseline and visit by treatment interactions.|Baseline and at Week 12 of each treatment period (up to Week 30)|ITT Population including off-treatment data. Number of par. represent those with data available at the time point; however, all par. in the ITT population without missing covariate information and with at least one post Baseline measurement are included.||Liters||Standard Error|Least Squares Mean
842439|NCT02275052|Secondary|Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Week 12 of Each Treatment Period|Trough FEV1 is a measure of lung function and is defined as the mean of FEV1 values obtained 23 and 24 hours after dosing on the previous day. Trough FEV1 measurements were taken electronically by spirometry on Day 2, Week 6 and Week 12. Baseline was the assessment recorded before dosing on Day 1 of each period. Mean Baseline is the mean of the Baselines for each participant. Period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Analysis was performed using a repeated measures model and the following covariates were included: period Baseline, mean Baseline, period, treatment, visit, smoking status, visit by period Baseline, visit by mean Baseline and visit by treatment interactions.|Baseline and at Week 12 of each treatment period (up to Week 30)|ITT Population including off-treatment data. Number of par. represent those with data available at the time point; however, all par. in the ITT population without missing covariate information and with at least one post Baseline measurement are included.||Liters||Standard Error|Least Squares Mean
842440|NCT02275052|Primary|Change From Baseline in Exercise Endurance Time (EET) Post-dose at Week 12 of Each Treatment Period|EET post-dose at W12 is defined as the EET obtained 3 hours after dosing at W12. EET was measured using the externally paced field walking test called endurance shuttle walk test (ESWT). Change from BL in EET at W12 was analyzed using a repeated measures model with covariates of period walking speed, mean walking speed, period, trt, visit (Day 2, W6 and W12), smoking status, visit by period walking speed, visit by mean walking speed and visit by trt interactions. BL was the EET assessment obtained prior to dosing on Day 1 of each period. The mean walking speed for each par. is the mean of the levels used for the ESWT in each of the two trt periods. Period walking speed for each par. and trt period is the difference between the level for that par. and period and the mean walking speed for that par. Intent-to-treat (ITT) Population: all randomized par., excluding those who were randomized in error, and par. who discontinued trt (off-trt).|Baseline (BL) and at Week (W) 12 of each treatment (trt) period (up to Week 30)|ITT Population including off-treatment data. Number of par. represent those with data available at the time point; however, all par. in the ITT population without missing covariate information and with at least one post Baseline measurement are included.||Seconds (s)||Standard Error|Least Squares Mean
842441|NCT02236611|Primary|Change From Baseline in Trough FEV1 on Day 85|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Day 85 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Day 84 (Week 12). Trough FEV1 measurements were taken electronically by spirometry on Days 2, 28, 56, 84 and 85. Baseline trough FEV1 is the mean of the two assessments made -30 and -5 minutes (min) pre-dose on Day 1. Change from baseline was calculated as the trough FEV1 value on Day 85 minus the BL value. Analysis performed using a repeated measures model with covariates of treatment, baseline FEV1, centre group, 24 hour subset flag, Day, Day by baseline and Day by treatment interactions. The least squares mean changes are presented here.|Baseline (BL) and Day 85|Per Protocol(PP) Population(pop): Participants(par) in the Intent-To-Treat pop who did not have a full protocol deviation considered to impact efficacy. Par represent those with data available at time point presented; however, all par. in the PP pop. without missing covariate information and >=1 post BL measurement are included in analysis||Liter||Standard Error|Least Squares Mean
842442|NCT02229487|Primary|GLP-1 Levels in Response to Oral Glucose Tolerance Test|Prediabetes patients with and without short sleep will undergo an oral glucose tolerance test with measurement of GLP-1 levels|2 weeks|||pmol/l.h||Inter-Quartile Range|Median
842487|NCT02162979|Secondary|Change in Dose of Anti-parkinsonian Medications||7 weeks||||||
842488|NCT02162979|Secondary|"Percent Change in on Time"|"on time is the period in which the subject is symptom free. We will track the amount of time the subject is considered symptom free before and after treatment. This value will be represented as a percent change."|4 weeks||||||
842478|NCT02164539|Secondary|Change in Clinic FEV1 Following 2 Puffs of Albuterol/Salbutamol Given 3 Hours Post-study Treatment Dose at Visit 5/Day 28|FEV1 is defined as forced expiratory volume in one second and measured in the morning at Visits 1 through 8 between 6:00 and 11:00 electronically by spirometry. Reversibility was measured at Visit 1 and Visit 2 for study eligibility by change in clinic FEV1 within 20 to 60 minutes following 4 inhalations of albuterol/salbutamol and again measured 3 hours after dosing at Visit 5 by change in clinic FEV1 30 minutes following 2 inhalations of albuterol/salbutamol. Baseline value of clinic FEV1 is the last acceptable/borderline acceptable (pre-dose) FEV1 value obtained prior to randomization (either from Visit 3 pre-dose or from Visit 2 pre-bronchodilator). Analysis performed using analysis of covariance with covariates of treatment, age, sex, baseline clinic trough FEV1, pre-albuterol/salbutamol FEV1 at Visit 5, pack years smoked per randomization stratification and age when first treated with an inhaler per randomization stratification.|Baseline and Day 28|ITT Population. Only those participants available at the specified time point were analyzed.||Liters (L)||Standard Error|Least Squares Mean
842479|NCT02164539|Secondary|Change From Trough in Clinic Forced Expiratory Volume (FEV1) at 3 Hours Post-study Treatment at Visit 5/Day 28|FEV1 was measured in the morning by spirometry. At Visit 5, after trough FEV1 is measured, subject received investigational product. 3 hours post-dose, spirometry was repeated and subject then received 2 puffs of albuterol/salbutamol. After 30 minutes,spirometry was repeated.. Change from Baseline in clinic trough (pre-dose) FEV1 is the difference in the trough value at 3 hours post-dose peak FEV1 and the Baseline value. If the trough value or the Baseline was missing, then change from Baseline was considered as missing. Baseline value of clinic FEV1 is the last acceptable/borderline acceptable (pre-dose) FEV1 value obtained prior to randomization (from Visit 3 pre-dose or from Visit 2 pre-bronchodilator). Analysis done using analysis of covariance with covariates of treatment, age, sex, baseline clinic trough FEV1, pre-dose trough FEV1 at Visit 5, pack years smoked per randomization stratification and age when first treated with an inhaler per randomization stratification.|Baseline and Day 28|ITT Population. Only those participants available at the specified time point were analyzed.||Liters (L)||Standard Error|Least Squares Mean
842480|NCT02164539|Secondary|Change From Baseline in Daily Morning (AM) PEF (Pre-dose and Pre-rescue Bronchodilator) Measured at Home and Averaged Over the Last 21 Days of Treatment Phase A|Peak expiratory flow (PEF) stability limit was calculated from AM PEF measurements on the 7 days preceding Visit 3 as mean AM PEF from the available 7 days preceding Visit 3 x 80%. PEF stability limit serves as a benchmark of the participants run-in COPD status and used for comparison during the treatment phase to assess subject safety. Change from Baseline over the last 21 days of Treatment Phase A is the difference between the last 21 days of Treatment Phase A and the appropriate Baseline week. The last 21 days of Treatment Phase A include the AM assessments on the date of Visit 6. AM assessments include the date of Visit 6 and the 20 consecutive days preceding the date of Visit. Analysis performed using analysis of covariance with covariates of treatment, age, sex, Baseline AM PEF, pack years smoked per randomization stratification and age when first treated with an inhaler per randomization stratification. Baseline is the last 7 days of the run-in period prior to randomization|Baseline and from Day 8 through Day 29|ITT Population. Only those participants available at the specified time point were analyzed.||Liters per minute (L/min)||Standard Error|Least Squares Mean
842481|NCT02164539|Secondary|Mean Change From Baseline in E-RS Total Scores at the End of Treatment Phase A|A daily symptoms score for exacerbations of chronic pulmonary disease tool - Respiratory Symptoms (E-RS) is derived by summing the 11 item-level E-RS scores and has a theoretical range of 0-40, with higher values indicating more severe respiratory symptoms. The Baseline E-RS score is defined as the mean within-subject daily score over the 7 days prior to randomization, with data present for a minimum of 4 of the 7 days. Change from Baseline at the end of Treatment Phase is the difference between the end of Treatment Phase value and the appropriate Baseline week. Analysis performed using analysis of covariance with covariates of treatment, age, sex, baseline score, pack years smoked per randomization stratification and age when first treated with an inhaler per randomization stratification. Baseline is the last 7 days of the run-in period prior to randomization. All comparisons for statistical purposes are with the FF 100 µg arm.|Baseline and End of Treatment Phase A (The end of Treatment Phase A was defined as the last 7 days of Treatment Phase A, including the AM assessments on the date of Visit 6)|ITT Population. Only those participants available at the specified time point were analyzed.||Score on scale||Standard Error|Least Squares Mean
842482|NCT02164539|Secondary|Mean Change From Baseline in Rescue Medication Use at the End of Treatment Phase A|All participants received the albuterol/salbutamol via MDI as a rescue medication on an as-needed basis. Total daily rescue medication use for a given day is the sum of daytime albuterol/salbutamol use recorded in PM and nighttime albuterol/salbutamol use recorded in AM the next day. The number of puffs of albuterol (salbutamol) MDI used in the last 12 hours for relief of symptoms were recorded morning and evening in the eDiary by the participants. End of Treatment Phase A is the last 7 days of Treatment Phase A. Change from Baseline at the end of Treatment Phase is the difference between the end of Treatment Phase value and the appropriate baseline week. Analysis performed using analysis of covariance with covariates of treatment, age, sex, baseline rescue medication use, pack years smoked per randomization stratification and age when first treated with an inhaler per randomization stratification. Baseline is the last 7 days of the run-in period prior to randomization|Baseline and End of Treatment Phase A (The end of Treatment Phase A was defined as the last 7 days of Treatment Phase A, including the AM assessments on the date of Visit 6)|ITT Population. Only those participants available at the specified time point were analyzed.||Puffs||Standard Error|Least Squares Mean
842483|NCT02164539|Primary|Change From Baseline in Clinic Trough Forced Expiratory Volume in One Second (FEV1) at the End of Treatment Phase A (Visit 6/Day 29)|FEV1 is defined as forced expiratory volume in one second and measured in the morning at Visits 1 through 8 between 6:00 and 11:00 electronically by spirometry. Change from Baseline in trough FEV1 is defined as the difference in the value obtained at Visit 6 (24 hours post-dose on Visit 5) and the last acceptable/borderline acceptable value obtained prior to randomization (from Visit 2 pre-bronchodilator or Visit 3 pre-dose). Trough FEV1 is defined as the acceptable/borderline acceptable FEV1 value obtained at Visit 6, approximately 24 hours after morning dosing on Visit 5. ITT population is comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. All comparisons for statistical purposes are with the FF 100 µg arm.|Baseline and Day 29|ITT Population. Only those participants available at the specified time point were analyzed.||Liters||Standard Deviation|Mean
842490|NCT02091869|Other Pre-specified|Comparison of Participant Usage Rates Between Mobile and Paper Asthma Action Plans|We measured the participant usage rates by frequency of a mobile asthma action plan compared to usage rates of a paper asthma action plan. No mobile usage data was collected for the paper asthma plan group; and no paper usage data was collected for mobile phone group.|Six months|Mobile phone usage was not assessed in the paper asthma action plan group.||times per week||Full Range|Median
842491|NCT02091869|Other Pre-specified|Comparison of Participant Usage Rates Between Mobile and Paper Asthma Action Plans|We measured the participant usage rates by frequency of a mobile asthma action plan compared to usage rates of a paper asthma action plan. No mobile usage data was collected for the paper asthma plan group; and no paper usage data was collected for mobile phone group.|Six months|Our staff biostatistician used a random number generator using ANCOVA model to assign all participants into either the mobile app or paper app groups per protocol. Three participants did not use the mobile app per protocol.||days per week||Full Range|Median
842492|NCT02091869|Secondary|Change in Asthma Self-Efficacy Scores|"The Child Self-Efficacy instrument is a 14 item validated questionnaire designed to measure the child's self-efficacy with regard to attack prevention and attack management. The child will be required to select one of 5 responses ranging from “not at all sure” (1 point); a little bit sure (2 points); fairly sure (3 points); quite sure (4 points) to “completely sure” (5 points). Total score range from 14-70. The attack prevention scale range from 6-30 and attack management range from 8-40. The higher score represent a greater degree of self-efficacy. The Cronbach’s α reliability = 0.75. The child self-efficacy questionnaire will be administered at baseline (pre-intervention) and at the end of the intervention (post-intervention)."|Baseline and Six months|Our staff biostatistician used a random number generator using ANCOVA model to assign all participants into either the mobile app or paper app groups per protocol.||units on a scale||Full Range|Median
842493|NCT02091869|Primary|Change in Asthma Control Test Scores|"The Asthma Control Test™ (ACT) is a 5 question health survey used to measure asthma control in individuals 12 years of age and older. The total sum scores range from 5-25. Higher scores mean that asthma is more controlled. The ACT is an efficient, reliable, and valid method of measuring asthma control, with or without, lung functioning measures such as spirometry. ACT helps identify and detect asthma patients who are not well controlled. ACT scores were examined pre- and post-intervention. A score total of 19 or less means asthma may not be well controlled. The timeframe is during the past 4 weeks. The scale range for Question 1 is all the time (1) to none of the time (5); Question 2 range: more than once a day (1) to not at all (5); Question 3 range: 4 or more nights a week (1) to not at all (5); Question 4 range: 3 or more times per day (1) to not at all (5); Question 5 range: not controlled at all (1) to completely controlled (5)."|Baseline and Six months|Our staff biostatistician used a random number generator using ANCOVA model to assign all participants into either the mobile app or paper app groups per protocol. The biostatistician was not be involved in testing or intervention procedures.||units on a scale||Full Range|Median
842494|NCT02068157|Secondary|Serum Alkaline DNase (SADA) Activity|SADA activity will be correlated with tumor response according to the guidelines of the revised Response Criteria in Solid Tumors 1.1.|Up to 12 months|The published assay could not be validated in murine samples. As such, no human samples were analyzed.|||||
842495|NCT02068157|Primary|Percentage of Participants With Complete Response or Partial Response According to RECIST v1.1|Tumor response rate according to Response Evaluation Criteria in Solid Tumors 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 12 months|All treated and eligible patients||percentage of participants||95% Confidence Interval|Number
842534|NCT01980888|Secondary|Minimal Residual Disease Negativity Rate at Week 36|Minimal residual disease (MRD) negativity rate is defined as the proportion of participants with MRD < 10^-4 assessed by flow cytometry in bone marrow at Week 36 after therapy initiation or at least 12 weeks after the last dose of rituximab or bendamustine (whichever is later) for participants receiving the final dose of rituximab after the original scheduled date. MRD negativity rate was to be assessed by an IRC.|Up to 22 months|The study was terminated in agreement with the FDA due to urgent safety measures. Complete data were not collected for any participant.|||||
842535|NCT01980888|Secondary|Overall Survival|Overall survival is defined as the interval from randomization to death from any cause. Overall survival was to be assessed by an IRC.|Up to 22 months|The study was terminated in agreement with the FDA due to urgent safety measures. Complete data were not collected for any participant.|||||
842536|NCT01980888|Secondary|Complete Response Rate|Complete response rate is defined as the proportion of participants who achieve a confirmed complete response. Complete response rate was to be assessed by an IRC.|Up to 22 months|The study was terminated in agreement with the FDA due to urgent safety measures. Complete data were not collected for any participant.|||||
842537|NCT01980888|Secondary|Nodal Response Rate|Nodal response rate is defined as the proportion of participants who achieve a 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters of index lesions. Nodal response rate was to be assessed by an IRC.|Up to 22 months|The study was terminated in agreement with the FDA due to urgent safety measures. Complete data were not collected for any participant.|||||
842538|NCT01980888|Secondary|Overall Response Rate|Overall response rate (ORR) is defined as the proportion of participants who achieve a confirmed complete or partial response. ORR was to be assessed by an IRC.|Up to 22 months|The study was terminated in agreement with the FDA due to urgent safety measures. Complete data were not collected for any participant.|||||
842539|NCT01980888|Primary|Progression-Free Survival|Progression-free survival (PFS) is defined as the interval from randomization to the first documentation of definitive disease progression or death from any cause. Definitive disease progression is CLL progression based on standard criteria, excluding lymphocytosis alone. PFS was to be assessed by an independent review committee (IRC).|Up to 22 months|"Intent to Treat (ITT) analysis set: all participants who are randomized in the study with treatment group designated according to initial randomization.
Due to early study termination, the prespecified efficacy analyses were not conducted. The PFS data presented are investigator assessments rather than IRC assessments."||months||95% Confidence Interval|Median
842605|NCT01797458|Secondary|Number of Children Experiencing Irreversible Pulpitis, Dental Abscess, or Extraction|Number of children experiencing irreversible pulpitis, dental abscess, or extraction judged clinically after 2 years|2 years|||Participants|||Count of Participants
842602|NCT01797458|Other Pre-specified|Children Perception of Pain Intensity|Child's perception of pain intensity during treatment assessed with the Visual Analogue Scale of Faces|Baseline assessment|||Participants|||Count of Participants
842603|NCT01797458|Other Pre-specified|Children Behavior|Child's behavior as assessed by the Frankl Behavior Rating Scale|Baseline assessment|||Participants|||Count of Participants
842604|NCT01797458|Other Pre-specified|Oral Health Status|Child`s oral health status as assessed by the gingival status and bacterial plaque index judged clinically after 1 and 2 years|1 and 2 years||||||
842634|NCT01696942|Secondary|Endoscopic Recurrence of Crohn's Disease|To compare the endoscopic recurrence rates at one year following surgery between patients treated with certolizumab and mesalamine.|One year following enrollment|No analysis performed due to low enrollment in each arm.|||||
842635|NCT01696942|Primary|Clinical Recurrence Rates of Crohn's Disease|To evaluate the difference in clinical recurrence rates between certolizumab and mesalamine after 4 weeks, 3 months, 6 months, 9 months, and 12 months of use following ileocolectomy for Crohn’s disease using the Crohn’s Disease Activity Index (CDAI).|One year following enrollment|No analysis performed due to low enrollment in each arm.|||||
842636|NCT01685242|Secondary|Tolerability of Study Medication at Visit 3A|Tolerability was assessed upon instillation of study medication, at 1 minute and 2 minutes post study medication instillation. Drop comfort was assessed using a 0-to 10 scale where 0=very comfortable and 10=very uncomfortable.|upon instillation, 1 minute and 2 minutes post instillation|Intent to Treat (ITT)||units on a scale||Standard Deviation|Mean
842637|NCT01685242|Secondary|Nasal Composite Score at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. For Nasal Composite Score the Total Composite Score ranges from 0 to 16, higher scores represent greater severity. Patients needed to have at least one of the nasal symptoms present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) each symptom was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Composite score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)||%participants with at least 1 nasal symp|||Number
842638|NCT01685242|Secondary|Nasal Composite Score at Duration of Action (8 Hours + 30 Minutes Post-dose)|A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. For Nasal Composite Score the Total Composite Score ranges from 0 to 16, higher scores represent greater severity. Patients needed to have at least one of the nasal symptoms present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) each symptom was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Composite score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)||%participants with at least 1 nasal symp|||Number
842639|NCT01685242|Secondary|Nasal Congestion at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Nasal Congestion was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Congestion score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)||units on a scale||Standard Deviation|Mean
842640|NCT01685242|Secondary|Nasal Congestion at Duration of Action (8 Hours + 30 Minutes Post-dose)|A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Nasal Congestion was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Congestion score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)||units on a scale||Standard Deviation|Mean
842641|NCT01685242|Secondary|Ear or Palate Pruritus at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Ear or Palate Pruritus was assessed by the patient on a single 0-4 scale (0=none to 4=severe). Ear or Palate Pruritus score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)||units on a scale||Standard Deviation|Mean
842642|NCT01685242|Secondary|Ear or Palate Pruritus at Duration of Action (8 Hours + 30 Minutes Post-dose)|A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Ear or Palate Pruritus was assessed by the patient on a single 0-4 scale (0=none to 4=severe). Ear or Palate Pruritus score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)||units on a scale||Standard Deviation|Mean
842643|NCT01685242|Secondary|Nasal Pruritus at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Nasal Pruritus was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Pruritus score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)||units on a scale||Standard Deviation|Mean
842644|NCT01685242|Secondary|Nasal Pruritus at Duration of Action (8 Hours + 30 Minutes Post-dose)|A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Nasal Pruritus was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Pruritus score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)||units on a scale||Standard Deviation|Mean
842645|NCT01685242|Secondary|Rhinorrhea at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Rhinorrhea was assessed by the patient on a 0-4 scale (0=none to 4=severe). Rhinorrhea score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)||units on a scale||Standard Deviation|Mean
842646|NCT01685242|Secondary|Rhinorrhea at Duration of Action (8 Hours + 30 Minutes Post-dose)|A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Rhinorrhea was assessed by the patient on a 0-4 scale (0=none to 4=severe). Rhinorrhea score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)||units on a scale||Standard Deviation|Mean
842647|NCT01685242|Secondary|Tearing at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Tearing was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of tearing score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)||units on a scale||Standard Deviation|Mean
842648|NCT01685242|Secondary|Tearing at Duration of Action (8 Hours + 30 Minutes Post-dose)|A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Tearing was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of tearing score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)||units on a scale||Standard Deviation|Mean
842649|NCT01685242|Secondary|Eyelid Swelling at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Eyelid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of eyelid swelling score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)||units on a scale||Standard Deviation|Mean
842650|NCT01685242|Secondary|Eyelid Swelling at Duration of Action (8 Hours + 30 Minutes Post-dose)|A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Eyelid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of eyelid swelling score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)||units on a scale||Standard Deviation|Mean
842651|NCT01685242|Secondary|Chemosis at Onset of Action (15 Minutes)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Chemosis was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of chemosis score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)||units on a scale||Standard Deviation|Mean
842652|NCT01685242|Secondary|Chemosis at Duration of Action (8 Hours + 30 Minutes Post-dose)|A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Chemosis was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of chemosis score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)||units on a scale||Standard Deviation|Mean
842653|NCT01685242|Secondary|Episcleral Redness at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Episcleral Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of episcleral redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)||units on a scale||Standard Deviation|Mean
842654|NCT01685242|Secondary|Episcleral Redness at Duration of Action (8 Hours + 30 Minutes Post-dose)|A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Episcleral Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of episcleral redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)||units on a scale||Standard Deviation|Mean
842655|NCT01685242|Secondary|Ciliary Redness at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Ciliary Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ciliary redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)||units on a scale||Standard Deviation|Mean
842656|NCT01685242|Secondary|Ciliary Redness at Duration of Action (8 Hours + 30 Minutes)|A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Ciliary Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ciliary redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)||units on a scale||Standard Deviation|Mean
842657|NCT01685242|Primary|Conjunctival Redness at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)||units on a scale||Standard Deviation|Mean
842658|NCT01685242|Primary|Conjunctival Redness at Duration of Action (8 Hours + 30 Minutes Post-dose)|A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)||units on a scale||Standard Deviation|Mean
842659|NCT01685242|Primary|Ocular Itching at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.|3, 5, 7 minutes post-CAC|Intent to Treat (ITT)||units on a scale||Standard Deviation|Mean
842660|NCT01685242|Primary|Ocular Itching at Duration of Action (8 Hours + 30 Minutes Post-dose)|A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.|3, 5, 7 minutes post-CAC|Intent to Treat (ITT)||units on a scale||Standard Deviation|Mean
842696|NCT01649856|Secondary|Median Duration of Rituximab Administration for Each Treatment Cycle|Duration of rituximab administration was defined as the time from start to end of the SC injection or IV infusion. The median duration was reported.|Cycles 1, 2, 3, 4, 5, 6, 7, and 8 (each cycle was 14 or 21 days)|Safety Population; n = number of participants in the analysis for the specified timepoint.||hours||Full Range|Median
842686|NCT01649856|Secondary|Duration of Overall Survival (OS)|OS was defined as the time from randomization to death from any cause.|Up to approximately 4.25 years|ITT Population.||months||Full Range|Median
842687|NCT01649856|Secondary|Number of Deaths||Up to approximately 4.25 years|ITT Population.||participants|||Number
842688|NCT01649856|Secondary|Duration of Progression-Free Survival (PFS)|PFS was defined as the time from randomization to first occurrence of disease progression, relapse, or death from any cause. Tumor response was assessed according to criteria published by Cheson et al (1999). Progression was defined as ≥50% increase in the sum of products of greatest diameters of any previously identified abnormal lymph node or the appearance of any new lesion. Relapse was defined as a new lesion or increase by ≥50% in size of previously involved sites, or ≥50% increase in greatest diameter of any previously identified node >1 cm, following an earlier assessment of CR or CRu.|Up to approximately 4.25 years|ITT Population.||months||Full Range|Median
842689|NCT01649856|Secondary|Number of Participants With Progression, Relapse, or Death|Tumor response was assessed according to criteria published by Cheson et al (1999). Progression was defined as ≥50% increase in the sum of products of greatest diameters of any previously identified abnormal lymph node or the appearance of any new lesion. Relapse was defined as a new lesion or increase by ≥50% in size of previously involved sites, or ≥50% increase in greatest diameter of any previously identified node >1 cm, following an earlier assessment of CR or CRu.|Up to approximately 4.25 years|ITT Population.||participants|||Number
842690|NCT01649856|Secondary|Duration of Disease-Free Survival (DFS)|DFS was defined as the time from date of initial CR/CRu to the date of relapse or death from any cause. Tumor response was assessed according to criteria published by Cheson et al (1999). Relapse was defined as a new lesion or increase by ≥50% in size of previously involved sites, or ≥50% increase in greatest diameter of any previously identified node >1 cm, following an earlier assessment of CR or CRu.|Up to approximately 4.25 years|ITT Population (Responder Subpopulation).||months||Full Range|Median
842691|NCT01649856|Secondary|Number of Participants With Relapse or Death at the Time of Primary Analysis|Tumor response was assessed according to criteria published by Cheson et al (1999). Relapse was defined as a new lesion or increase by ≥50% in size of previously involved sites, or ≥50% increase in greatest diameter of any previously identified node >1 cm, following an earlier assessment of CR or CRu. The number of participants who had experienced relapse or death prior to the clinical cut-off date (October 2014) was determined.|Up to approximately 2 years (assessed at Baseline, Day 1 of each cycle [maximum 8 cycles; each cycle was 14 or 21 days], every 3 months thereafter, and/or 4 weeks after early termination)|ITT Population (Responder Subpopulation): All participants who achieved CR or CRu after 4 cycles.||participants|||Number
842692|NCT01649856|Secondary|Duration of EFS|EFS was defined as the time from randomization to first occurrence of disease progression, relapse, initiation of other anti-lymphoma therapy, or death, whichever occurred first. Tumor response was assessed according to criteria published by Cheson et al (1999). Progression was defined as a ≥50% increase in the sum of products of greatest diameters of any previously identified abnormal lymph node or the appearance of any new lesion. Relapse was defined as a new lesion or increase by ≥50% in size of previously involved sites, or ≥50% increase in greatest diameter of any previously identified node >1 cm, following an earlier assessment of CR or CRu.|Up to approximately 4.25 years|ITT Population.||months||Full Range|Median
842693|NCT01649856|Secondary|Number of Participants With an Event-Free Survival (EFS) Event|EFS events included disease progression, relapse, initiation of other anti-lymphoma therapy, or death. Tumor response was assessed according to criteria published by Cheson et al (1999). Progression was defined as greater than or equal to (≥) 50% increase in the sum of products of greatest diameters of any previously identified abnormal lymph node or the appearance of any new lesion. Relapse was defined as a new lesion or increase by ≥50% in size of previously involved sites, or ≥50% increase in greatest diameter of any previously identified node >1 cm, following an earlier assessment of CR or CRu.|Up to approximately 4.25 years|ITT Population.||participants|||Number
842694|NCT01649856|Secondary|Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle|"Hospital time was defined as the amount of time the participant was in the hospital for the course of one cycle of rituximab + CHOP chemotherapy. Where the hospital time was not documented for a given cycle, it was reported as Missing."|Cycles 1, 2, 3, 4, 5, 6, 7, and 8 (each cycle was 14 or 21 days)|Safety Population.||percentage of participants|||Number
842695|NCT01649856|Secondary|Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle|"Chair time was defined as the amount of time the participant occupied an infusion chair/bed for a single treatment cycle of rituximab + CHOP chemotherapy. Where the chair time was not documented for a given cycle, it was reported as Missing."|Cycles 1, 2, 3, 4, 5, 6, 7, and 8 (each cycle was 14 or 21 days)|Safety Population.||percentage of participants|||Number
842697|NCT01649856|Secondary|Rituximab Administration Satisfaction Questionnaire (RASQ) Domain Scores|The RASQ is a 20-item questionnaire that measures five domains related to the impact of treatment administration. These include physical impact, psychological impact, impact on activities of daily living (ADLs), convenience, and satisfaction. Each domain is scored on a scale of 0 to 100, with higher scores indicative of more positive feelings toward therapy. The score for each domain was averaged among all participants.|At Cycle 7 (each cycle was 14 or 21 days)|ITT Population (RASQ Subpopulation): All participants who completed the RASQ at Cycles 3 and 7; n = number of participants in the analysis for the specified domain.||units on a scale||Standard Deviation|Mean
842698|NCT01649856|Secondary|Cancer Treatment Satisfaction Questionnaire (CTSQ) Domain Scores|The CTSQ is a validated 16-item questionnaire that measures three domains related to satisfaction with cancer therapy. These include expectations of therapy, feelings about side effects, and satisfaction with therapy. Each domain is scored on a scale of 0 to 100, with higher scores indicative of more positive feelings toward therapy. The score for each domain was averaged among all participants.|At Cycle 7 (each cycle was 14 or 21 days)|ITT Population (CTSQ Subpopulation): All participants who completed the CTSQ at Cycles 3 and 7; number (n) = number of participants in the analysis for the specified domain.||units on a scale||Standard Deviation|Mean
842699|NCT01649856|Primary|Percentage of Participants With Complete Response (CR) or Complete Response Unconfirmed (CRu)|Tumor response was assessed per criteria published by Cheson et al (1999). According to consensus recommendations, CR was defined as complete disappearance of all clinical and radiographic evidence of disease and disease-related symptoms, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. CRu was defined as disappearance of clinical and radiographic evidence of disease and absence of splenomegaly, with regression of lymph nodes by greater than (>) 75 percent (%) but still >1.5 centimeters (cm) in size, and indeterminate bone marrow assessment. The percentage of participants with either response at the end of induction (EOI) was determined with corresponding 95% Pearson-Clopper confidence interval (CI).|Up to approximately 4.25 years|Intent-to-Treat (ITT) Population: All participants who completed Baseline and at least one on-treatment efficacy assessment.||percentage of participants||95% Confidence Interval|Number
842700|NCT01639001|Secondary|Percentage of Participants With Treatment-emergent AEs (Treatment Related)|An AE was any untoward medical occurrence attributed to study treatment in a participant who received study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs were to be collected from first dose until 28 days after the last dose of study medication. SAEs could be collected after this timeframe if considered to be treatment related. Grade 3 and 4 AEs in the below table indicated severe AE and life-threatening consequences respectively; Grade 5 indicated death related to AE. Chemotherapy group in the below table, only includes data before crossover to crizotinib for those participants who crossed over to receive crizotinib treatment.|From the first dose of study medication until 28 days after the last dose of study medication. However all AEs entered in the database from the treatment start were included in AE analyses (assessed up to 33 months)|All randomized participants who received at least 1 dose of study treatment, with treatment assignments designated according to actual study treatment received during the first cycle.||Percentage of participants|||Number
842701|NCT01639001|Secondary|Percentage of Participants With Treatment-emergent Adverse Events (AEs; All Causalities)|An AE was an untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes: death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, congenital anomaly. Treatment-emergent AEs were those with initial onset or that worsen in severity after the first dose of study medication. AEs were to be collected from first dose until 28 days after the last dose of study medication. SAEs could be collected after this timeframe if considered to be treatment related. Grade 3 and 4 AEs in below table indicated severe AE and life-threatening consequences respectively; Grade 5 indicated death due to AE. Chemotherapy group in the below table includes data before crossover to crizotinib for participants who crossed over to receive crizotinib.|From the first dose of study medication until 28 days after the last dose of study medication. However all AEs entered in the database from the treatment start were included in AE analyses (assessed up to 33 months)|All randomized participants who received at least 1 dose of study treatment, with treatment assignments designated according to actual study treatment received during the first cycle.||Percentage of participants|||Number
842702|NCT01639001|Secondary|Agreement Between Central Laboratory ALK FISH and ALK IHC Test Results - Molecular Profiling Evaluable|Agreement between central laboratory anaplastic lymphoma kinase (ALK) fluorescence in situ hybridization (FISH) and ALK immunohistochemistry (IHC) test results is based on analysis of participants in the Molecular Profiling (MP) evaluable population that have an ALK IHC result and an ALK FISH result of either positive or negative only. This MP evaluable population included participants who screen failed, which their ALK test results were negative based on FISH test. Tumor tissue samples from these screen failure participants were consented and kept. These samples served as a part of negative sample set for evaluation of IHC test and/or polymerase chain reaction (PCR) to determine ALK fusion events. Participants with FISH results of uninformative and assay not performed and IHC results of valid IHC status not available were excluded from the analysis of agreement between central laboratory ALK FISH and ALK IHC test results.|Screening, less than or equal to 28 days prior to dosing.|The MP evaluable population included 812 participants, of which there were 771 participants that had a test result (positive or negative) from both the FISH test and the IHC test.||Number of participants|||Number
842703|NCT01639001|Secondary|Percentage of Participants With Visual Disturbance as Assessed by Visual Symptom Assessment Questionnaire (VSAQ-ALK)|"The participants who responded to the question: Have you experienced any visual disturbances? Only the participants who answered yes were instructed to complete the rest of the questionnaire. N was the number of participants who had completed the first question."|Cycle 1 Day 1 to end of treatment or withdrawal, no later than 4 weeks (+/- 1 week) from last dose of study medication or when the decision was taken to withdraw from the study (whichever was sooner, assessed up to 33 months)|Participants from the safety analysis population who completed a baseline and at least 1 post-baseline PRO assessment.||Percentage of participants|||Number
842704|NCT01639001|Secondary|Change From Baseline in General Health Status as Assessed by EQ-5D- Index|EQ-5D is a standardized, participant-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a visual analog scale (VAS). EQ-5D summary index is obtained with a formula that weights each level of the 5 dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health).|Cycle 1 Day 1 to end of treatment or withdrawal, no later than 4 weeks (+/- 1 week) from last dose of study medication or when the decision was taken to withdraw from the study (whichever was sooner, assessed up to 33 months)|Participants from the safety analysis population who completed a baseline and at least 1 post-baseline PRO assessment.||Units on a scale||95% Confidence Interval|Mean
842705|NCT01639001|Secondary|Change From Baseline in General Health Status as Assessed by EuroQol 5D (EQ-5D)- Visual Analog Scale (VAS)|EQ-5D is a standardized, participant-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a visual analog scale (VAS). The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.|Cycle 1 Day 1 to end of treatment or withdrawal, no later than 4 weeks (+/- 1 week) from last dose of study medication or when the decision was taken to withdraw from the study (whichever was sooner, assessed up to 33 months)|Participants from the safety analysis population who completed a baseline and at least 1 post-baseline PRO assessment.||Units on a scale||95% Confidence Interval|Mean
842706|NCT01639001|Secondary|Change From Baseline in Lung Cancer Symptom Scores as Assessed by the EORTC Quality of Life Questionnaire-Lung Cancer 13 (QLQ- LC13)|The QLQ-LC13 consisted of 1 multi-item scale and 9 single items that assessed the specific symptoms (dyspnea, cough, hemoptysis, and site specific pain), side effects (sore mouth, dysphagia, neuropathy, and alopecia), and pain medication use of lung cancer participants receiving chemotherapy. The QLQ-LC13 Alopecia, Coughing, Dysphagia, Dyspnoea, Haemoptysis, Pain in arm or shoulder, Pain in chest, Pain in other parts, Peripheral neuropathy, and Sore mouth each ranged from 0-100 with higher scores indicating a high level of symptomatology/problems.|Cycle 1 Day 1 to end of treatment or withdrawal, no later than 4 weeks (+/- 1 week) from last dose of study medication or when the decision was taken to withdraw from the study (whichever was sooner, assessed up to 33 months)|Participants from the safety analysis population who completed a baseline and at least 1 post-baseline PRO assessment.||Units on a scale||95% Confidence Interval|Mean
842707|NCT01639001|Secondary|Change From Baseline Scores in QLQ-C30 Symptoms as Assessed by the EORTC-QLQ-C30|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). The QLQ-C30 Appetite loss, Constipation, Diarrhea, Dysponea, Fatigue, Financial difficulties, Insomnia, Nausea/vomiting, and Pain each ranged from 0-100 with higher scores indicating a high level of symptomatology/problems.|Cycle 1 Day 1 to end of treatment or withdrawal, no later than 4 weeks (+/- 1 week) from last dose of study medication or when the decision was taken to withdraw from the study (whichever was sooner, assessed up to 33 months)|Participants from the safety analysis population who completed a baseline and at least 1 post-baseline PRO assessment.||Units on a scale||95% Confidence Interval|Mean
842708|NCT01639001|Secondary|Change From Baseline in Functioning and Global Quality of Life (QOL) as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). The QLQ-C30 Global QOL, Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, and Social Functioning each ranged from 0-100 with higher scores indicating a better level of functioning or better quality of life.|Cycle 1 Day 1 to end of treatment or withdrawal, no later than 4 weeks (+/- 1 week) from last dose of study medication or when the decision was taken to withdraw from the study (whichever was sooner, assessed up to 33 months)|Participants from the safety analysis population who completed a baseline and at least 1 post-baseline PRO assessment.||Units on a scale||95% Confidence Interval|Mean
842709|NCT01639001|Secondary|Time to Deterioration (TTD) in Participant Reported Pain, Dyspnea, or Cough|TTD in pain in chest, dyspnea, or cough from the Quality of Life Questionnaire Supplement Module for Lung Cancer (QLQ-LC13) was a composite endpoint defined as the time from randomization to the earliest time the participant’s scale scores showed a 10 point or greater increase after baseline in any of the 3 symptoms.|From Baseline to deterioration while on study treatment. For participants with no deterioration, the data was censored at the last date when QLQ-LC13 assessment for pain, dyspnea, or cough was completed (assessed up to 33 months)|Participants from the safety analysis population who completed a baseline and at least 1 post-baseline PRO assessment.||Months||95% Confidence Interval|Median
842710|NCT01639001|Secondary|Extracranial Time To Progression (EC-TTP) Based on IRR|EC-TTP was defined similarly to TTP, but only considering extracranial disease (excluding intracranial disease) and the progression was determined based on either new extracranial lesions or progression of existing extracranial lesions.|Randomization to objective extracranial progression or last tumor assessment without progression before any additional anti-cancer therapy (whichever occurred first, assessed up to 33 months)|FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization.||Months||95% Confidence Interval|Median
842711|NCT01639001|Secondary|Intracranial Time To Progression (IC-TTP) Based on IRR|IC-TTP was defined similarly to TTP, but only considering intracranial disease (excluding extracranial disease) and the progression was determined based on either new brain metastases or progression of existing brain metastases.|Randomization to objective intracranial progression or last tumor assessment without progression before any additional anti-cancer therapy (whichever occurred first, assessed up to 33 months)|FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization.||Months||95% Confidence Interval|Median
842712|NCT01639001|Secondary|Time To Progression (TTP) Based on IRR|TTP was defined as the time from the date of randomization to the date of the first documentation of objective tumor progression, as determined by IRR. If tumor progression data included more than 1 date, the first date was used. TTP (in months) was calculated as (first event date − randomization date +1)/30.44.|Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (whichever occurred first, assessed up to 33 months)|FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization.||Months||95% Confidence Interval|Median
842713|NCT01639001|Secondary|Time to Tumor Response (TTR) Based on IRR|TTR was defined as the time from randomization to first documentation of objective tumor response (CR or PR) as determined by the IRR. For participants proceeding from PR to CR, the onset of PR was taken as the onset of response. TTR was calculated for the subgroup of participants with objective tumor response.|Randomization to first documentation of objective tumor response (assessed up to 33 months)|FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization. N=Participants who had objective tumor response by IRR.||Weeks||Full Range|Median
842714|NCT01639001|Secondary|Duration of Response (DR) Based on IRR|DR was defined as the time from the first documentation of objective tumor response (CR or PR), as determined by the IRR, to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. DR (in weeks) was calculated as (first date of PD or death − first date of CR or PR +1)/7. DR was only calculated for the subgroup of participants with an objective tumor response.|From objective response to date of progression, death or last tumor assessment without progression before any additional anti-cancer therapy (whichever occurred first, assessed up to 33 months)|FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization. N = Participants with objective tumor response by IRR.||Weeks||95% Confidence Interval|Median
842715|NCT01639001|Secondary|Estimate of the Percentage of Participants Surviving at 1 Year and at 18 Months|Probability of survival 1 year and 18 month after randomization. The probability of survival at 1 year was estimated using the Kaplan Meier method and a 2-sided 95% CI for the log [-log(1-year survival probability)] was calculated using a normal approximation and then back transformed to give a CI for the 1-year survival probability itself. The probability of survival at 18 months was estimated similarly.|From randomization to 18 months|The FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization.||Percentage of paricipants||95% Confidence Interval|Number
842716|NCT01639001|Secondary|Percentage of Participants With Disease Control at 12 Weeks Based on IRR|Disease Control Rate (DCR) at 12 weeks is defined as the percent of participants with CR, PR or stable disease (SD) at 12 weeks according to RECIST version 1.1 as determined by the IRR. The best response of SD can be assigned if SD criteria were met at least once after randomization at a minimum interval of 6 weeks. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions and disappearance of all non-target lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.|From randomization to Week 12|FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization.||Percentage of participants||95% Confidence Interval|Number
842717|NCT01639001|Secondary|Overall Survival (OS)|OS was defined as the time from randomization to the date of death due to any cause. OS (in months) was calculated as (date of death − date of randomization +1)/30.44.|From randomization to death or last date known alive for those not known to have died (whichever occurred first, assessed up to 33 months)|FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization.||Months||95% Confidence Interval|Median
842718|NCT01639001|Secondary|Objective Response Rate (ORR) - Percentage of Participants With Objective Response Based on IRR|Percentage of participants with objective response of complete response (CR) or partial response (PR) according to RECIST version 1.1. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions and disappearance of all non-target lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.|Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (assessed up to 33 months)|FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization.||Percentage of participants||95% Confidence Interval|Number
842719|NCT01639001|Primary|Progression-Free Survival (PFS) Based on IRR by Treatment Arm|PFS was defined as the time from the date of randomization to the date of the first documentation of objective tumor progression (by IRR) or death on study due to any cause, whichever occured first. If tumor progression data included more than 1 date, the first date was used. PFS (in months) was calculated as (first event date − randomization date +1)/30.44. Progression is defined using RECIST v1.1, as at least a 20% increase (including an absolute increase of at least 5 millimeters) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.|Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (whichever occurred first, assessed up to 33 months)|The Full Analysis (FA) population included all participants who were randomized with study treatment assignment designated according to the initial randomization.||Months||95% Confidence Interval|Median
842746|NCT01612767|Secondary|Angina Pectoris Classification|"Evaluate the angina pectoris classification at each study visit.
Stable angina pectoris was classified according to the Canadian Cardiovascular Society's System: Stable Angina - Class I: normal activity does not cause angina; Stable Angina - Class II: slight limitation of normal activity, moderate exertion may cause angina; Stable Angina - Class III: marked limitation of ordinary physical activity; Stable Angina - Class IV: discomfort with any physical activity and pain may be present at rest
Unstable angina pectoris was classified according to the Braunwald System: Numeral I: newly onset severe or accelerated angina with no pain at rest; Numeral II: angina at rest within the preceding month but not the past 48 hours Numeral III: angina at rest within the preceding 48 hours; Letter A: develops in presence of conditions which intensify ischemia; Letter B: develops in the absence of extracardiac conditions; Letter C: develops within 2 weeks after an acute myocardial infarction"|Basline, Discharge, 1, 9, 12, 24 and 36 months post-index procedure|Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.||Percentage of participants|||Number
842747|NCT01612767|Secondary|Lesion Success During the Index Procedure|Evaluate the lesion success associated with the implant of the PRO-Kinetic Energy stent. Lesion success is defined as the successful delivery and deployment of the investigational stent at the intended target lesion in combination with any adjunctive device (if applicable) to attain a final residual stenosis of < 30% by operator visual estimate.|Index procedure|||Percentage of participants|||Number
842748|NCT01612767|Secondary|Device Success During the Index Procedure|Evaluate the device success associated with the implant of the PRO-Kinetic Energy stent. Device success is defined as the successful delivery and deployment of the investigational stent at the intended target lesion in combination with standard post-dilation (if applicable) to attain a final residual stenosis of < 30% by operator visual estimate.|Index procedure|||Percentage of participants|||Number
842749|NCT01612767|Secondary|Index Procedure Success|Evaluate the index procedure success associated with the implant of the PR-Kinetic Energy stent. procedure success is defined as the successful delivery and deployment of the investiational stent at the intended target lesion in combination with any adjunctive device (if applicable) to attain a final residual stenosis of < 30% by operator visual estimate without the occurrence of cardiac death, any MI (target vessel or non-target vessel) or TLR prior to hospital discharge.|Index procedure|||Percentage of participants|||Number
842750|NCT01612767|Secondary|Stent Thrombosis Rate|Evaluate the stent thrombosis rate associated with the PRO-Kinetic Energy stent. Stent thrombosis was classified according to both timing and evidence as outlined by the ARC definition of stent thrombosis. Participants were included in the evaluations at visit intervals if they had a visit at the specified interval or a thrombosis was reported at or before the visit.|1, 9, 12, 24 and 36 months post-index procedure|Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.||Percentage of participants||95% Confidence Interval|Number
842751|NCT01612767|Secondary|All-cause Mortality and All-cause MI - Contribution of Individual Rates|Contribution of the individual rates of mortality and myocardial infarction to the overall composite safety rate.|1, 9, 12, 24, and 36 months post-index procedure|Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.||Percentage of participants|||Number
842752|NCT01612767|Secondary|Composite of All-cause Mortality and All-cause MI|Characterize the overall safety of the PRO-Kinetic Energy stent by evaluating the composite rate of all-cause mortality and all-cause myocardial infarction.|1, 9, 12, 24, and 36 months post-index procedure|Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.||Percentage of participants||95% Confidence Interval|Number
842753|NCT01612767|Secondary|Overall Target Lesion Revascularization Rate|Evaluate the overall target lesion revascularization rate associated with the PRO-Kinetic Energy stent. The overall target lesion revascularization rate includes both ischemia-driven revascularization procedures of the target lesion, as well as revascularization procedures of the target lesion without prior clinical symptoms.|1, 9, 12, 24 and 36 months post-index procedure|Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.||Percentage of participants||95% Confidence Interval|Number
842754|NCT01612767|Secondary|Target Lesion Failure Rate - Contribution of Individual Event Types|The contribution of each individual event of cardiac death, myocardial infarction, and ischemia-driven target lesion revascularization to the overall rate of target lesion failure.|1, 9, 12, 24, and 36 months post-index procedure|Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.||Percentage of participants|||Number
842755|NCT01612767|Secondary|Overall Target Lesion Failure Rate|Evaluate the target lesion failure rate of the PRO-Kinetic Energy stent. Target lesion failure includes cardiac death, MI, and ischemia-driven target lesion revascularization.|1, 9, 12, 24 and 36 months post-index procedure|Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.||Percentage of participants||95% Confidence Interval|Number
842756|NCT01612767|Secondary|Overall Target Vessel Revascularization Rate|Evaluate the overall target vessel revascularization rate of the PRO-Kinetic Energy stent. The rate includes both ischemia-driven revascularization procedures of the target vessel, as well as revascularization procedures of the target vessel without prior clinical symptoms.|1, 9, 12, 24 and 36 months post-index procedure|Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.||Percentage of participants||95% Confidence Interval|Number
842757|NCT01612767|Secondary|Target Vessel Failure Rate - Contribution of Individual Event Types|Contribution of each event type (cardiac death, myocardial infarction (MI) and ischemia-driven target vessel revascularization) to composite rate of target vessel failure.|1, 12, 24 and 36 months post-index procedure|Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.||Percentage of participants|||Number
842758|NCT01612767|Secondary|Target Vessel Failure Rate|Evaluate the target vessel failure rate at 1, 12, 24, and 36 months post-index procedure. Target vessel failure is defined as cardiac death, myocardial infarction (MI) and ischemia-driven target vessel revascularization.|1, 12, 24 and 36 months post-index procedure|Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.||Percentage of participants||95% Confidence Interval|Number
842759|NCT01612767|Primary|Target Vessel Failure Rate|The primary endpoint for the Pro-Kinetic Energy Stent is the target vessel failure rate at 9-months post-index procedure. Target vessel failure is defined as cardiac death, myocardial infarction and ischemia-driven target vessel revascularization.|9 months post-index procedure|||Percentage of participants||95% Confidence Interval|Number
842765|NCT01597791|Primary|Rate of Positive Urine Culture (Bacteriuria)|This study will be assessed by collecting a twenty-four to forty-eight hour midstream urine sample and performing a urine culture. The clinical and laboratory criteria used to define a urinary tract infection in a woman immediately|48 Hours|||participants with positive urine culture|||Number
842775|NCT01550757|Primary|A Primary Outcome for This Study is the Number of Non-acute Emergency Department Visits.|A primary outcome for this study is non-acute emergency department visits.|Two years.|Veterans enrolled in the study based on the type of care they received at VA and then randomized to receive a peer or not.||number of visits||Standard Deviation|Mean
842811|NCT01514760|Secondary|Number of Participants That Utilized the Asthma Action Plan|The frequency of utilization of the Asthma Action Plan for acute symptoms among the study population will be measured and compared to responses of daily prompts that will ask participants to record whether they used rescue medication.|Eight weeks|||participants|||Number
842812|NCT01514760|Primary|Mobile Asthma Action Plan (AAP) Usage|Median number of days per week (range 0-7) the Asthma Action Plan was utilized to record routine (daily) symptoms or peak flow measurements.|Eight weeks|||days per week||Full Range|Median
842807|NCT01542541|Secondary|SUVavg in Each Colonic Segment||Day 2|||Units||Standard Deviation|Mean
842808|NCT01542541|Primary|SUVmax of FDG in Each Colonic Segment||Day 2|||SUV||Standard Deviation|Mean
842809|NCT01514760|Secondary|Asthma Control Test™ Scores|"The Asthma Control Test™ (ACT) is a 5 question health survey used to measure asthma control in individuals 12 years of age and older. The total sum scores range from 5-25. Higher scores mean that asthma is more controlled. The ACT is an efficient, reliable, and valid method of measuring asthma control, with or without, lung functioning measures such as spirometry. ACT helps identify and detect asthma patients who are not well controlled. ACT scores were examined pre- and post-intervention. A score total of 19 or less means asthma may not be well controlled. The timeframe is during the past 4 weeks. The scale range for Question 1 is all the time (1) to none of the time (5); Question 2 range: more than once a day (1) to not at all (5); Question 3 range: 4 or more nights a week (1) to not at all (5); Question 4 range: 3 or more times per day (1) to not at all (5); Question 5 range: not controlled at all (1) to completely controlled (5)."|Baseline and eight weeks|All participants and participants with uncontrolled asthma at baseline. The number of participant with uncontrolled asthma 10.||units on a scale||Standard Deviation|Mean
842810|NCT01514760|Secondary|Asthma Self-Efficacy for Adolescent Children|"The Child Self-Efficacy instrument is a 14 item validated questionnaire designed to measure the child's self-efficacy with regard to attack prevention and attack management. The child will be required to select one of 5 responses ranging from “not at all sure” (1 point); a little bit sure (2 points); fairly sure (3 points); quite sure (4 points) to “completely sure” (5 points). Total score range from 14-70. The higher score represent a greater degree of self-efficacy. The Cronbach’s α reliability = 0.75. The child self-efficacy questionnaire will be administered at baseline (pre-intervention) and at the end of the intervention (post-intervention)."|Baseline and eight weeks|||units on a scale||Standard Deviation|Mean
842913|NCT01376323|Secondary|Number of Participants With HbA1c < 7.0% and < 6.5%|Data has been presented for number of participants with their corresponding percentages with HbA1c <7.0% and <6.5%.|Up to Week 12|PD population. Only those participants available at the specified time points were analyzed.||Participants|||Count of Participants
842914|NCT01376323|Secondary|Change From Baseline in Fructosamine at Week 6 and Week 12|Change from Baseline was calculated by subtracting the Baseline values from the corresponding post-treatment values. Baseline was defined as mean of Day -1 visit. Statistics is provided for least square mean. It was assessed on Baseline (Day -1), Day 41 and Week 12.|Baseline (Day -1) and Week 12|PD population. Only those participants available at the specified time points were analyzed.||Micromoles per liter||Standard Deviation|Mean
842915|NCT01376323|Secondary|Summary of Homeostatic Model Assessment (HOMA) Index Calculated From Change From Baseline in Fasting Insulin and Fasting Glucose at Week 12|Mean of triplicate measurements at pre-dose time point was considered for the summary. HOMA was calculated by multiplying insulin concentration with glucose concentration divided by 22.5. Change from Baseline for insulin and glucose was calculated by subtracting the Baseline values from the corresponding post-treatment values. Baseline was defined as mean of Day 1 pre-dose visit. Statistics is provided for least square mean. It was assessed on Day 1 (pre-dose), 2 (pre-dose), Week 6 (pre-dose) and Week 12.|Baseline (Day 1) and up to Week 12|PD population. Only those participants available at the specified time points were analyzed.||Index||Standard Deviation|Mean
842916|NCT01376323|Secondary|Change From Baseline in Fasting Insulin at Week 12|Mean of triplicate measurements at pre-dose time point were considered for the summary. Change from Baseline was calculated by subtracting the Baseline values from the corresponding post-treatment values. Baseline was defined as mean of Day 1 pre-dose visit. Statistics is provided for least square mean at Week 12. It was assessed on Day 1 (pre-dose), 2 (pre-dose), Week 6 (pre-dose) and Week 12.|Baseline (Day 1) and up to Week 12|PD population. Only those participants available at the specified time points were analyzed.||Picomoles per liter||Standard Deviation|Mean
842917|NCT01376323|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 12|Mean of triplicate measurements at pre-dose time point were considered for the summary. Change from Baseline was calculated by subtracting the Baseline values from the corresponding post-treatment values. Baseline was defined as mean of Day 1 pre-dose visit. Statistics is provided for least square mean at Week 12. It was assessed on Day 1 (pre-dose), 2 (pre-dose), Week 6 (pre-dose) and Week 12.|Baseline (Day 1) and up to Week 12|PD population. Only those participants available at the specified time points were analyzed.||Millimoles per liter||Standard Deviation|Mean
842918|NCT01376323|Secondary|GSK256073 AUC and HbA1c at Week 12 Was Evaluated to Establish the Exposure-response Pharmacokinetic/Pharmacodynamic (PK/PD) Relationship|The relationships between drug exposure and HbA1c and relative PD endpoints of interest was planned to be plotted graphically. The data for this outcome measure was not collected.|Up to Week 12|PD population. The data for this outcome measure was not collected.|||||
842919|NCT01376323|Secondary|Change From Baseline in 12 Hour Non-esterified Fatty Acids (NEFA) and Glucose Weighted Mean Concentration Value at Day 2 and at Week 6|Change from Baseline was calculated by subtracting the Baseline values from the corresponding post-treatment values. Baseline was defined as weighted mean value at Day 1 visit. Statistics is provided for least square mean at Week 6. It was assessed on Baseline (Day 1), Day 2 and Week 6.|Baseline (Day 1) and up to Week 6|PD population. Only those participants available at the specified time points were analyzed.||Millimoles per liter||Standard Deviation|Mean
842920|NCT01376323|Primary|Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12|Blood samples for analysis of HbA1c were collected at Baseline (Day -1), Day 41, Week 9 and Week 12. Change from Baseline was calculated by subtracting the Baseline values from the corresponding post-treatment values. Baseline was defined as Day -1 visit. Statistics is provided for least square mean at Week 12.|Baseline (Day -1) and up to Week 12|Pharmacodynamic (PD) population comprised of all participants who provide pharmacodynamic data. Only those participants available at the specified time points were analyzed.||Percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
842921|NCT01376323|Primary|Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick|Urinalysis parameters included glucose, protein, blood and ketones by dipstick. It was assessed on Baseline (Day -1) and 12. Urine glucose was measured as grams per deciliter (G/dL).|Up to Week 12|Safety population. Only those participants available at the specified time points were analyzed.||Participants|||Count of Participants
842922|NCT01376323|Primary|Number of Participants With Hematology Abnormalities of Potential Clinical Importance (PCI)|Hematology parameters included platelet, red blood cell (RBC) count, mean corpuscular volume (MCV), neutrophils, white blood cell (WBC) count (absolute), mean corpuscular hemoglobin (MCH), lymphocytes, reticulocyte count, mean corpuscular hemoglobin concentration (MCHC), monocytes, hemoglobin, eosinophils, hematocrit and basophils. It was assessed on Baseline (pre-dose Day 1) and 12. Data for parameters with high and low of PCI is provided.|Up to Week 12|Safety population||Participants|||Count of Participants
842923|NCT01376323|Primary|Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance (PCI)|Clinical chemistry parameters included blood urea nitrogen (BUN), potassium, aspartate aminotransferase (AST), total bilirubin, direct bilirubin, creatinine, chloride, alanine aminotransferase (ALT), uric acid, fasting glucose, total carbon dioxide, gamma glutamyltransferase (GGT), albumin, sodium, calcium, alkaline phosphatase (ALP), total protein, creatine phosphokinase (CPK) and fasting lipid panel including total cholesterol, triglycerides, high density lipoprotein (HDL) cholesterol and low density lipoprotein (LDL) cholesterol. It was assessed on Baseline (pre-dose Day 1), Week 3 and 12. Data for parameters with high and low of PCI is provided.|Up to Week 12|Safety population||Participants|||Count of Participants
842924|NCT01376323|Primary|Number of Participants With Abnormal Electrocardiograms (ECGs) Findings|Single 12-lead ECGs were obtained at each time point during the study using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and QTc intervals. It was assessed at Baseline (pre-dose Day 1), Day 2, Week 3, Week 6 and 12. Participants with normal, abnormal not clinically significant and abnormal clinically significant ECG were presented.|Up to Week 20|Safety population. Only those participants available at the specified time points were analyzed.||Participants|||Count of Participants
842925|NCT01376323|Primary|Change From Baseline in Heart Rate|Mean of triplicate measurements at each time point was considered for the summary. Baseline was defined as pre-dose of Day 1 visit. Change from Baseline was calculated by subtracting the Baseline values from the corresponding post-treatment values. It was assessed on Baseline (pre-dose Day 1), Day 1 (12 hours), Day 2, Week 3, 6, 9 and 12.|Baseline (pre-dose Day 1) and up to Week 12|Safety population. Only those participants available at the specified time points were analyzed.||Beats per minute||Standard Deviation|Mean
842926|NCT01376323|Primary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Mean of triplicate measurements at each time point was considered for the summary. Baseline was defined as pre-dose of Day 1 visit. Change from Baseline was calculated by subtracting the Baseline values from the corresponding post-treatment values. It was assessed on Baseline, Day 1 (12 hours), Day 2 (pre-dose and 12 hours), Week 3, 6 (pre-dose and 12 hours), 9 and 12.|Baseline (pre-dose Day 1) and up to Week 12|Safety population. Only those participants available at the specified time points were analyzed.||Millimeters of mercury||Standard Deviation|Mean
842927|NCT01376323|Primary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury.|Up to Week 12|Safety population was used which was defined as all participants who received at least one dose of study drug.||Participants|||Count of Participants
842976|NCT01342211|Secondary|Number of Treatment-Emergent Adverse Events (TEAEs) by Severity|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Investigator assessed TEAEs as mild (did not interfere with participant’s usual function), moderate (interfered to some extent with participant’s usual function) or severe (interfered significantly with participant's usual function). TEAEs are events between first dose of study drug and up to Day 141 that were absent before treatment or that worsened relative to pretreatment state.|Day 1 up to Day 141|Safety analysis set included all participants who received at least 1 dose of study drug.||adverse events|||Number
842966|NCT01345253|Secondary|Time to First Severe SLE Flare Index (SFI) Flare Over 52 Weeks.|Time to first severe SLE flare is defined as the number of days from first treatment until the participant had an event (event date-treatement start date +1). If a participant had a severe SFI flare and received protocol restricted medication then the event date was the earliest of the first severe SFI flare date, and the treatment failure date. Analysis of severe SFI flare was performed on the modified SELENA SLEDAI SLE flare index in which the modification excluded severe flares that were triggered only by an increase in SELENA SLEDAI score to >12. Analysis was from Cox proportional hazards model for the comparison between belimumab and placebo adjusting for country, Baseline SELENA SLEDAI score (<=9 vs. >=10) and complement levels (low C3 and/or C4 vs. no low C3 or C4).|52 weeks|MITT Population||Days||Inter-Quartile Range|Median
842967|NCT01345253|Secondary|Number of Days of Daily Prednisone Dose <=7.5 mg/Day and/or Reduced by 50 Percent From Baseline Over 52 Weeks.|Number of days of daily prednisone dose <=7.5 mg/day and/or reduced by 50 percent over time through each scheduled visit during the blinded period were compaired between belimumab and placebo using Rank ANCOVA model which was used for comparing belimumab and placebo. The independent variables in the model included treatment group, Baseline prednisone dose level, country, Baseline SELENA SLEDAI score (<=9 vs. >=10) and complement levels (low C3 and/or C4 vs. no low C3 or C4). This analysis was perfomed on the participants who used prednisone >7.5 mg/day at Baseline.|Week 52|MITT Population||Days||Inter-Quartile Range|Median
842968|NCT01345253|Secondary|Percent of Participants With SRI7 Response at Week 52.|SRI7 response is defined as the percent of participants with >=7 point reduction from Baseline in SELENA SLEDAI score and no worsening (increase of < 0.30 points from Baseline) in PGA and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with Baseline at the time of assessment (at Week 52 of the blinded period). A SELENA SLEDAI score of 0 would suggest no lupus activity; while a score of 105 is the maximum calculable if all items were scored as being present from active lupus. PGA ranges from 0 (no activity) to 3 (severe activity). BILAG has no range. The higher thresholds of SELENA SLEDAI improvement (i.e., SRI5, SRI6, and SRI7) indicates a higher response (SRI5 is a 5 point SELENA SLEDAI reduction, SRI6 is a 6 point reduction, and SRI7 is a 7 point reduction).|Baseline (Day 0) and Week 52|MITT Population. Only those participants available at the specified time point were analyzed.||Percentage of participants|||Number
842969|NCT01345253|Secondary|Percent of Participants With >=4 Point Reduction From Baseline in SELENA SLEDAI Score at Week 52.|The SELENA SLEDAI score is a weighted index for assessing SLE disease activity in which signs and symptoms, laboratory tests and physician's assessment for each of 9 organ system were given a weighted score and summed if present at the time of the visit or in the preceding 10 days. A SELENA SLEDAI score of 0 would suggest no lupus activity; while a score of 105 is the maximum calculable if all items were scored as being present from active lupus. A decrease of 4 points or more equates to a clinically meaningful improvement. The Baseline value of a variable is defined as the value of the variable measured at Day 0 prior to dosing. In case of multiple results on Day 0 prior to dosing, the latest result was used. If a Day 0 value was not available, the last available value prior to Day 0 was used.|Baseline (Day 0) and Week 52|MITT Population. Only those participants available at the specified time points were analyzed.||Percentage of participants|||Number
842970|NCT01345253|Primary|Percent of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response Rate at Week 52.|SRI response is a composite index, defined as the percent of participants with >=4 point reduction from Baseline in safety of estrogen in lupus national assessment (SELENA) systemic lupus erythematosus disease activity index (SLEDAI) score and no worsening (increase of < 0.30 points from Baseline) in physicians global assessment (PGA) and no new British isles lupus assessment group (BILAG) A organ domain score or 2 new BILAG B organ domain scores compared with Baseline at the time of assessment (at Week 52 of the blinded period). A SELENA SLEDAI score of 0 would suggest no lupus activity; while a score of 105 is the maximum calculable if all items were scored as being present from active lupus. PGA ranges from 0 (no activity) to 3 (severe activity). BILAG has no range. The higher thresholds of SELENA SLEDAI improvement (i.e., SRI5, SRI6, and SRI7) indicates a higher response (SRI5 is a 5 point SELENA SLEDAI reduction, SRI6 is a 6 point reduction, and SRI7 is a 7 point reduction).|Week 52|Modified Intention-to-Treat (MITT) Population: all participants who were randomized and treated with at least one dose of study treatment, with exclusion of participants from the site 086485.||Percentage of participants|||Number
842971|NCT01342211|Other Pre-specified|Percent Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141|Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration.|Baseline, Day 29, 57, 71, 85, 99, 127, 141|Efficacy analysis set. 'number analyzed' = participants who were evaluable for specified time points for each arm. Results for percent change at Day 85 in Lp(a) was not reported because data was not collected for Lp(a) at Day 85 due to an inadvertent omission in the protocol.||percent change||Standard Deviation|Mean
842972|NCT01342211|Other Pre-specified|Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141|Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration.|Baseline, Day 29, 57, 71, 85, 99, 127, 141|Efficacy analysis set. 'number analyzed' = participants who were evaluable for specified time points for each arm. Results for change at Day 85 in Lp(a) was not reported because data was not collected for Lp(a) at Day 85 due to an inadvertent omission in the protocol.||mg/dL||Standard Deviation|Mean
842973|NCT01342211|Secondary|Number of Participants With Anti-drug Antibody (ADA)|Human serum ADA samples of participants who received PF-04950615 (RN316) were analyzed for the presence of anti-PF-04950615 (RN316) antibodies by using the semi quantitative enzyme-linked immunosorbent assay (ELISA). Results with titer value >=4.32 nanogram per milliliter of anti-PF-04950615 antibodies were counted as positive. Number of participants with presence of anti-PF-04950615 antibodies were reported in this outcome measure.|Day 1 up to Day 141|Analysis set included all participants who received at least 1 dose of PF-04950615 (RN316).||participants|||Number
842974|NCT01342211|Secondary|Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters|Criteria for clinical significant vital signs: maximum increase or decrease from baseline in supine systolic blood pressure (BP) greater than or equal to (>=) 30 millimeter of mercury (mmHg), maximum increase or decrease from baseline in supine diastolic BP of >=20 mmHg. Criteria for clinically significant ECG parameters: maximum increase of >=25 percent (%) for baseline value of >200 millisecond (msec) and maximum increase of >=50% for baseline value of less than or equal to (<=) 200 msec for PR and QRS interval; maximum increase from baseline of >30 to <=60 msec and maximum increase from baseline of >60 msec for QT interval corrected using the Fridericia's formula (QTCF).|Day 1 up to Day 141|Safety analysis set included all participants who received at least 1 dose of study drug.||participants|||Number
842975|NCT01342211|Secondary|Number of Participants With Clinically Relevant Laboratory Abnormalities|Hematology (hemoglobin[hgb],hematocrit,red blood cell[RBC]<0.8*lower limit of normal[LLN],mean cell[MC] volume,MC hgb,MC hg concentration <0.9*LLN, greater than[>] 1.1*upper limit of normal[ULN], platelet <0.5*LLN,>1.75*ULN, white blood cell[WBC]<0.6*LLN,>1.5*ULN,neutrophil,lymphocyte <0.8*LLN,>1.2*ULN,eosinophil,basophil,monocyte >1.2*ULN);chemistry(total, direct, indirect bilirubin[BR]>1.5*ULN,aspartate aminotransferase[AT],alanine AT,alkaline phosphatase,gamma-glutyl transferase>3.0*ULN,protein,lactate dehydrogenase <0.8*LLN,>1.2*ULN,creatinine,blood urea nitrogen>1.3*ULN,uric acid >1.2*ULN,potassium,chloride,calcium,bicarbonate<0.9*LLN,>1.1*ULN, sodium<0.95*LLN,>1.05*ULN,glucose[GL]<0.6*LLN,>1.5*ULN,amylase,lipase >1.5*ULN,creatinine kinase>2.0*ULN);urinalysis(pH <4.5,>8,specific gravity<1.003 , >1.030, GL,ketone,protein,hgb,BR,nitrite,leukocyte greater than or equal to [>=]1, RBC, WBC >=20);coagulation(prothrombin[PT],PT international ratio,partial thromboplastin time>1.1*ULN).|Day 1 up to Day 141|Safety analysis set included all participants who received at least 1 dose of study drug. Here 'N' signifies those participants who were evaluable for this outcome measure.||participants|||Number
842977|NCT01342211|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs are events between first dose of study drug and up to Day 141 that were absent before treatment or that worsened relative to pretreatment state. Treatment related: a TEAE deemed related to the study drug by the investigator. TEAEs included SAEs (TESAEs) as well as non-serious AEs which occurred during the study. The participants with TEAEs, SAEs and treatment-related TEAEs were reported.|Day 1 up to Day 141|Safety analysis set included all participants who received at least 1 dose of study drug.||participants|||Number
842978|NCT01342211|Secondary|Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85|Lipid parameters included: high-density lipoprotein cholesterol (HDL-C), total cholesterol (TC), non-high-density lipoprotein-cholesterol (non-HDL-C), triglyceride (TG), apolipoprotein B (ApoB) and apolipoprotein A1 (ApoA1). Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration.|Baseline, Day 29, 57, 85|Efficacy analysis set. 'number analyzed' = participants who were evaluable at specified time points for each arm. Results for percent change at Day 85 for ApoB and ApoA1 were not reported because data was not collected for ApoB and ApoA1 at Day 85 due to an inadvertent omission in the protocol.||percent change||Standard Deviation|Mean
842979|NCT01342211|Secondary|Change From Baseline in Lipid Parameters at Day 29, 57 and 85|Lipid parameters included: high-density lipoprotein cholesterol (HDL-C), total cholesterol (TC), non-high-density lipoprotein-cholesterol (non-HDL-C), triglyceride (TG), apolipoprotein B (ApoB) and apolipoprotein A1 (ApoA1). Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration.|Baseline, Day 29, 57, 85|Efficacy analysis set. 'number analyzed' = participants who were evaluable at specified time points for each arm. Results for change at Day 85 in lipid parameters ApoB and ApoA1 were not reported because data was not collected for ApoB and ApoA1 at Day 85 due to an inadvertent omission in the protocol.||milligram per deciliter (mg/dL)||Standard Deviation|Mean
842980|NCT01342211|Secondary|Percentage of Participants Achieving at Least 30 Percent Decrease in Low-density Lipoprotein Cholesterol (LDL-C)||Day 29, 57, 85|Efficacy analysis set included all participants who received at least 1 dose of study drug and completed the Day 85 visit or dropped out prematurely, whichever was earlier. 'N' = participants who were evaluable for this outcome measure and 'number analyzed' = participants who were evaluable at specified time points for each arm.||percentage of participants|||Number
842981|NCT01342211|Secondary|Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 and <100 Milligram Per Deciliter (mg/dL)||Day 29, 57, 85|Efficacy analysis set included all participants who received at least 1 dose of study drug and completed the Day 85 visit or dropped out prematurely, whichever was earlier. 'N' = participants who were evaluable for this outcome measure and 'number analyzed' = participants who were evaluable at specified time points for each arm.||percentage of participants|||Number
842982|NCT01342211|Primary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Day 85|Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration.|Baseline, Day 85|Efficacy analysis set included all participants who received at least 1 dose of study drug and completed the Day 85 visit or dropped out prematurely, whichever was earlier. Here 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure.||percent change||Standard Deviation|Mean
842991|NCT01328444|Secondary|Change From Baseline in 3-hours Post-dose FEV1 at Week 12 of Each Treatment Period|FEVI is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Baseline is the FEV1 value recorded pre-dose on Day 1 of each treatment period, mean Baseline is the mean of the Baselines for each participant, and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Clinic visit post-dose FEV1 at Week 12 (Treatment Day 85) is defined as the FEV1 value obtained 3 hours after dosing on Treatment Day 85. Analysis performed using a repeated measures model with covariates of period Baseline, mean Baseline, period, treatment, visit, smoking status, center group, visit by period Baseline, visit by mean Baseline and visit by treatment interactions 3 hour post-dose FEV1 measurements were taken electronically by spirometry on Day 2, Week 6 and Week 12.|Week 12 of each treatment period (up to Study Week 29)|Intent-to-Treat (ITT) population: all par. randomized to treatment who received at least one dose of study drug in either treatment period. Number of par. represent those with data available at the time point; however, all par. in the ITT population without missing covariate information and with at least one post Baseline measurement are included.||Liters||Standard Error|Least Squares Mean
842992|NCT01328444|Secondary|Change From Baseline in Residual Volume (Trough and 3-hours Post-dose) at Week 12 of Each Treatment Period|Residual Volume (RV) is defined as the air that remains in the lungs after breathing out as fully as possible. Baseline is the RV value recorded pre-dose on Day 1 of each treatment period, mean Baseline is the mean of the Baselines for each participant, and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Trough RV is measured pre-dose on Treatment Week 12. RV 3-hours post-dose is measured from the value obtained 3 hours after dosing on Treatment Week 12. Analysis performed using a repeated measures model with covariates of period Baseline, mean Baseline, period, treatment, visit, smoking status, center group, visit by period Baseline, visit by mean Baseline and visit by treatment interactions. RV measurements were taken electronically by plethysmography on Day 2, Week 6 and Week 12.|Week 12 of each treatment period (up to Study Week 29)|Intent-to-Treat (ITT) population: all par. randomized to treatment who received at least one dose of study drug in either treatment period. Number of par. represent those with data available at the time point; however, all par. in the ITT population without missing covariate information and with at least one post Baseline measurement are included.||Liters||Standard Error|Least Squares Mean
842993|NCT01328444|Secondary|Change From Baseline in Functional Residual Capacity (Trough and 3-hours Post-dose) at Week 12 of Each Treatment Period|Functional Residual Capacity (FRC) is defined as the amount of air still left in the lungs after breathing out normally. Baseline is the FRC value recorded pre-dose on Day 1 of each treatment period, mean Baseline is the mean of the Baselines for each participant, and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Trough FRC is measured pre-dose on Treatment Week 12. FRC 3-hours post-dose is measured from the value obtained 3 hours after dosing on Treatment Week 12. Analysis performed using a repeated measures model with covariates of period Baseline, mean Baseline, period, treatment, visit, smoking status, center group, visit by period Baseline, visit by mean Baseline and visit by treatment interactions. FRC measurements were taken electronically by plethysmography on Day 2, Week 6 and Week 12.|Week 12 of each treatment period (up to Study Week 29)|Intent-to-Treat (ITT) population: all par. randomized to treatment who received at least one dose of study drug in either treatment period. Number of par. represent those with data available at the time point; however, all par. in the ITT population without missing covariate information and with at least one post Baseline measurement are included.||Liters||Standard Error|Least Squares Mean
842994|NCT01328444|Secondary|Change From Baseline in Inspiratory Capacity (Trough and 3-hours Post-dose) at Week 12 of Each Treatment Period|Inspiratory capacity (IC) is defined as the maximum amount of air that can be inhaled into the lungs from the normal resting position after breathing out normally. Baseline is the IC value recorded pre-dose on Day 1 of each treatment period, mean Baseline is the mean of the Baselines for each participant, and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Trough IC is measured pre-dose on Treatment Week 12 of each treatment period. IC 3-hours post-dose is measured from the value obtained 3 hours after dosing on Treatment Week 12 of each treatment period. Analysis performed using a repeated measures model with covariates of period Baseline, mean Baseline, period, treatment, visit, smoking status, center group, visit by period Baseline, visit by mean Baseline and visit by treatment interactions. IC measurements were taken electronically by plethysmography on Day 2, Week 6 and Week 12.|Week 12 of each treatment period (up to Study Week 29)|Intent-to-Treat (ITT) population: all par. randomized to treatment who received at least one dose of study drug in either treatment period. Number of par. represent those with data available at the time point; however, all par. in the ITT population without missing covariate information and with at least one post Baseline measurement are included.||Liters||Standard Error|Least Squares Mean
842995|NCT01328444|Primary|Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Week 12 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 measurements were taken electronically by spirometry on Day 2, Week 6 and Week 12. Baseline is the FEV1 value recorded pre-dose on Day 1 of each treatment period, mean Baseline is the mean of the Baselines for each participant, and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Clinic visit trough (pre-bronchodilator and pre-dose) FEV1 at Week 12 (Treatment Day 85) is defined as the FEV1 value obtained 24 hours after dosing on Treatment Day 84. Analysis performed using a repeated measures model with covariates of period Baseline, mean Baseline, period, treatment, visit, smoking status, center group, visit by period Baseline, visit by mean Baseline and visit by treatment interactions.|Week 12 of each treatment period (up to Study Week 29)|Intent-to-Treat (ITT) Population: all par. randomized to treatment who received at least one dose of study drug in either treatment period. Number of par. represent those with data available at the time point; however, all par. in the ITT population without missing covariate information and with at least one post Baseline measurement are included.||Liters||Standard Error|Least Squares Mean
842996|NCT01328444|Primary|Change From Baseline in Exercise Endurance Time Post-dose at Week 12 of Each Treatment Period|Exercise endurance time (EET) post-dose at Week 12 is defined as the EET obtained 3 hours after dosing at Week 12. EET was measured using the externally paced field walking test called the endurance shuttle walk test (ESWT). Analysis performed using a repeated measures model with covariates of period walking speed, mean walking speed, period, treatment, visit, smoking status, center group, visit by period walking speed, visit by mean walking speed and visit by treatment interactions. The model used all available 3-hour post-dose change from baseline EET values recorded on Day 2, Week 6 and Week 12. Baseline was the EET assessment obtained prior to dosing on Day 1 of each period. The mean walking speed for each participant is the mean of the levels used for the ESWT in each of the two treatment periods. The period walking speed for each participant and treatment period is the difference between the level for that participant and period and the mean walking speed for that participant.|Week 12 of each treatment period (up to Study Week 29)|Intent-to-Treat (ITT) Population: all par. randomized to treatment who received at least one dose of study drug in either treatment period. Number of par. represent those with data available at the time point; however, all par. in the ITT population without missing covariate information and with at least one post Baseline measurement are included.||Seconds||Standard Error|Least Squares Mean
842997|NCT01313637|Other Pre-specified|Change From Baseline in the Mean Shortness of Breath With Daily Activities (SOBDA) Score for Week 24|The newly developed SOBDA questionnaire assesses dyspnea or shortness of breath (SOB) with daily activities. The SOBDA questionnaire is made up of 13 items completed by the participant (par.) each evening prior to bedtime, when the par. is instructed to reflect on the current day’s activities. The daily score is computed as the mean of the scores on the 13 items (>=7 items must have non-missing responses for this to be calculated). The par. is assigned a weekly mean SOBDA score ranging from 1 to 4 (greater scores indicate more severe breathlessness with daily activities) based on the mean of 7 days of data (>=4 of 7 days must be completed for a weekly mean to be calculated). Change from BL is the mean weekly SOBDA score minus BL. Analysis was performed using MMRM with covariates of treatment, BL (mean score in the week prior to treatment), smoking status, center group, week, week by BL and week by treatment interactions. This MMRM analysis only included Weeks 4, 8, 12, and 24.|Baseline and Week 24|Intent-to-Treat (ITT) Population: all par. randomized to trt. who received at least one dose of randomized study drug. Par. represents those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis.||Scores on a scale||Standard Error|Least Squares Mean
842998|NCT01313637|Secondary|Change From Baseline in Weighted Mean (WM) 0-6 Hour FEV1 Obtained Post-dose at Day 168|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The WM FEV1 was derived by calculating the area under the FEV1/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. The WM was calculated at Days 1, 28, 84, and 168 using the 0-6-hour post-dose FEV1 measurements collected on that day, which included pre-dose (Day 1: 30 minutes [min] and 5 min prior to dosing; other serial visits: 23 and 24 hours after the previous morning dose) and post-dose at 15 min, 30 min, 1 hour, 3 hours, and 6 hours. Change from Baseline at a particular visit was calculated as the WM at that visit minus Baseline. Analysis was performed using a repeated measures model with covariates of treatment, Baseline (mean of the two assessments made 30 min and 5 min pre-dose on Day 1), smoking status, center group, day, and day by Baseline and day by treatment interactions.|Baseline and Day 168|Intent-to-Treat (ITT) Population: all par. randomized to trt. who received at least one dose of randomized study drug. Par. represents those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis.||Liters||Standard Error|Least Squares Mean
842999|NCT01313637|Secondary|Mean Transition Dyspnea Index (TDI) Focal Score at Day 168 (Week 24)|Considered an 'other' endpoint by the FDA. The TDI is an interviewer-administered instrument which measures the changes in the participant's dyspnea from Baseline. This questionnaire was collected on Days 28, 84 and 168. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI scores ranged from -3 (major deterioration) to +3 (major improvement); total score = -9 to 9. Analysis was performed using a repeated measures model with covariates of treatment, Baseline dyspnea index (BDI) focal score,smoking status, center group, day, day by BDI focal score and day by treatment interactions.|Day 168 (Week 24)|Intent-to-Treat (ITT) Population: all par. randomized to trt. who received at least one dose of randomized study drug. Par. represents those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis.||Scores on a scale||Standard Error|Least Squares Mean
843000|NCT01313637|Primary|Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 169 (Week 24)|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 measurements were taken electronically by spirometry on Days 2, 28, 56, 84, 112, 168, and 169. Baseline is defined as the mean of the assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1. Trough FEV1 is defined as the mean of the FEV1 values obtained at 23 and 24 hours after the previous morning's dosing (ie., trough FEV1 on Day 169 is the mean of the FEV1 values obtained 23 and 24 hours after the morning dosing on Day 168). Change from Baseline at a particular visit was calculated as the trough FEV1 at that visit minus Baseline. Analysis was performed using a repeated measures model with covariates of treatment, Baseline , smoking status, center group, day, and day by Baseline and day by treatment interactions. ITT=Intent-to-Treat; par.=participants.|Baseline and Day 169|Intent-to-Treat (ITT) Population: all par. randomized to trt. who received at least one dose of randomized study drug. Par. represents those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis.||Liters||Standard Error|Least Squares Mean
843287|NCT01086384|Secondary|Change From Baseline in Evening Pre-dose Trough FEV1 at Week 36|Evening pre-dose trough (lowest value) forced expiratory volume in one second (FEV1) was measured using spirometry equipment that met or exceeded the minimal performance recommendations of the American Thoracic Society. FEV1 is a measure of the maximum amount of air forcefully exhaled in one second. Change from Baseline in evening pre-dose FEV1 was analyzed using an Analysis of Covariance (ANCOVA) model with effects due to Baseline FEV1, sex, age, region, and treatment. Change from Baseline was calculated as the Week 36 value minus the Baseline value.|Baseline and Week 36|ITT Population. Only those participants available at the indicated time point (Week 36) were analyzed.||Liters||Standard Deviation|Least Squares Mean
843288|NCT01086384|Secondary|Number of Severe Asthma Exacerbations|A severe asthma exacerbation is defined as a deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. A participant may have had one or more exacerbations.|Baseline to Follow-up (up to 76 weeks of treatment)|ITT Population||Severe asthma exacerbations|||Number
843289|NCT01086384|Primary|Number of Participants With 1 or More Severe Asthma Exacerbations|Asthma is a medical condition that causes narrowing of the small airways in the lungs. A severe asthma exacerbation is defined as a deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. Only events deemed by the adjudication committee to be severe asthma exacerbations were used in the analysis of severe asthma exacerbations. The time to the first severe asthma exacerbation was analyzed using a Cox proportional hazards regression model, adjusting for Baseline disease severity (Baseline forced expiratory volume in one second [FEV1, maximum amount of air forcefully exhaled in one second]), sex, age, and region.|Baseline to Follow-up (up to 76 weeks of treatment)|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study medication.||participants|||Number
843306|NCT01061671|Secondary|Pharmacogenetics and Pharmacoepigenetics of Statin Therapy in COPD||one time point within study period||||||
843307|NCT01061671|Secondary|The Effect of Current Smoking Status on Inflammatory Biomarker Levels and Response to Simvastatin Treatment||up to 37 months||||||
843308|NCT01061671|Secondary|Rate of Combined Cardiovascular Events||up to 37 months||||||
843309|NCT01061671|Secondary|Systemic and Lung-specific Biomarkers of Inflammation and Procoagulant Activity||up to 37 months||||||
843310|NCT01061671|Secondary|Acute Exacerbation COPD Hospitalization Rates (Events/Patient Year)||up to 37 months|Analysis excludes participants without any follow-up data.||events per patient year||95% Confidence Interval|Mean
843311|NCT01061671|Secondary|Change in FEV1 (% Pred) From Baseline to Last Measure||Baseline, last measure at up to 37 months|Analysis excludes participants without any follow-up data.||percent predicted||90% Confidence Interval|Median
843312|NCT01061671|Secondary|Time to First COPD Exacerbation||up to 37 months|Analysis excludes participants without any follow-up data.||Days to the first exacerbation||95% Confidence Interval|Median
843313|NCT01061671|Primary|Rates of COPD Exacerbations||up to 37 months|Analysis excludes participants without any follow-up data.||exacerbations/person-year||Standard Deviation|Mean
843335|NCT01015118|Secondary|Change in Global Health Status/ Quality of Life (QoL) Scale Over Time.|"Change in Global Health Status/ Quality of life (QoL) over time was calculated on Global Health Status/QoL scale (composite of items 29 and 30 of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-30 (EORTC QLQ-C30) as a general measure.
As specified in the EORTC scoring manual, for each scale or item, a linear transformation was applied to standardize the raw score to a range from 0 to 100 (high scores represent a high/healthy level of functioning).
Mean presented is Adjusted mean. Adjusted for the stratification factors macroscopic residual postoperative tumour at baseline (yes vs. no), FIGO stage (IIB−III vs IV), and Carboplatin level (AUC5 vs. AUC6)."|First drug administration until final DBL 26September16, upto 62 months|Randomised Set (RS) for patients with global health status/QoL||units on a scale||Standard Error|Mean
843336|NCT01015118|Secondary|Change in Abdominal/Gastro-intestinal Symptoms Over Time|"Change in abdominal/gastro-intestinal over time was calculated on symptoms (scale composite of items 31 to 37 of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Module for Ovarian Cancer 28 (EORTC QLQ OV-28).
As specified in the EORTC scoring manual, for each scale or item, a linear transformation was applied to standardize the raw score to a range from 0 to 100 (high scores represent a high/severe level of symptomatology).
Mean presented is Adjusted mean. Adjusted for the stratification factors macroscopic residual postoperative tumour at baseline (yes vs. no), FIGO stage (IIB−III vs IV), and Carboplatin level (AUC5 vs. AUC6)."|First drug administration until final DBL 26September16, upto 62 months|Randomised Set (RS) for patients with abdominal/gastro-intestinal symptoms||units on a scale||Standard Error|Mean
843337|NCT01015118|Secondary|Objective Response Based on Investigator Assessment|Objective tumour response defined as either complete response [CR] or partial response [PR] in patients with at least 1 target lesion reported at baseline|First drug administration until final DBL 26September16, upto 62 months|Randomised Set (RS) for patients with at least 1 target lesion reported at baseline||percentage of participants|||Number
843338|NCT01015118|Secondary|Time to CA-125 Tumour Marker Progression|Time to tumour-marker progression was defined as the time from randomisation until the date when Carbohydrate (cancer) antigen (CA-125) values increased to higher than twice the nadir value. CA-125 >=2 x nadir in case nadir value > Upper limit of normal (ULN) or CA-125 >=2 x ULN in case nadir value <= ULN.|First drug administration until final DBL 26September16, upto 62 months|Randomised set (RS)||Months||Inter-Quartile Range|Median
843339|NCT01015118|Secondary|Overall Survival|"Overall survival is defined as time from randomization to date of death (irrespective of reason).
Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment arm."|First drug administration to date of death until final DBL 26September16, upto 62 months|Randomised Set (RS)||Months||Inter-Quartile Range|Median
843340|NCT01015118|Secondary|PFS Based on Investigator Assessment According to mRECIST Version 1.1 (Key Secondary Endpoint - Follow up Analysis).|Follow-up analysis was conducted at the time of overall survival analysis. Progression free survival is calculated as the time from randomisation to the date of disease progression, or to the date of death, whichever occurs first based on the Investigator assessment according to Modified Response Evaluation Criteria (mRECIST), version 1.1. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment arm.|First drug administration to date of disease progression or death whichever occurs first until final Data Base Lock (DBL) 26September16, upto 62 months|Randomised Set (RS)||Months||Inter-Quartile Range|Median
843341|NCT01015118|Secondary|PFS Based on Investigator Assessment According to mRECIST Version 1.1 (Key Secondary Endpoint).|"Progression free survival is calculated as the time from randomisation to the date of disease progression, or to the date of death, whichever occurs first based on the Investigator assessment according to Modified Response Evaluation Criteria (mRECIST), version 1.1.
The primary PFS analysis of this trial was performed when approximately 753 patients had experienced a PFS event.
Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment arm."|First drug administration to date of disease progression or death whichever occurs first , upto 29 months|Randomised Set (RS)||Months||Inter-Quartile Range|Median
843342|NCT01015118|Primary|PFS Based on Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumors, Version 1.1 (mRECIST), and Additional Clinical Criteria (Follow up Analysis).|"Follow-up analysis was conducted at the time of overall survival analysis. Progression free survival (PFS) is calculated as the time from randomisation to the date of disease progression, or to the date of death, whichever occurs first according to the Investigator assessment.
Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment arm."|First drug administration to date of disease progression or death whichever occurs first until final Data Base Lock (DBL) 26September16, upto 62 months|Randomised Set (RS)||Months||Inter-Quartile Range|Median
843343|NCT01015118|Primary|PFS Based on Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumors, Version 1.1 (mRECIST), and Additional Clinical Criteria.|"Progression free survival (PFS) is calculated as the time from randomisation to the date of disease progression, or to the date of death, whichever occurs first according to the Investigator assessment.
The primary PFS analysis of this trial was performed when approximately 753 patients had experienced a PFS event
Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment arm."|First drug administration to date of disease progression or death whichever occurs first , upto 29 months|Randomised Set (RS)||Months||Inter-Quartile Range|Median
843409|NCT00936910|Secondary|Number of Participants With Negative Cultures on Day 5 and Day 30 During the Test of Cure Period Post Antifungal Lock|Records the number of participants with 2 negative cultures who completed the trial and had (-) test of cure cultures on day 5 and 30|30 days|All children with long term venous access with fungal related central line infections were eligible for enrollment in the trial. No one was excluded because of age, sex, race or ethnicity.||participants|||Number
843410|NCT00936910|Secondary|The Development of Fungal-related Complications|Records the number of fungal related adverse complications that occurred|Usually 1-28 days|All children with long term central line access with fungal-related central line infections were eligible for enrollment. No one was excluded due to sex, age, race, or ethnicity||adverse complications|||Number
843411|NCT00936910|Secondary|The Number of Days Before the Infected Central Line Culture Becomes Negative|Records the mean number of days required for the cultures to become negative|5 days of antifungal lock treatment|All children with long term venous access with central line fungal related infections were eligible for enrollment in the trial. No one was excluded because of age, sex, or ethinicity||days||Full Range|Mean
843412|NCT00936910|Primary|Number of Patients With 2 Negative Fungal Cultures After 5 Days of Combined Systemic Antifungal and Antifungal Lock Therapy and the CVC Was Not Removed|Records the number of patients with 2 negative fungal cultures after 5 days of combined systemic antifungal and antifungal lock therapy and the CVC was not removed|5 days of antifungal lock treatment|13 children with long term central line venous access with positive central line fungal infections were enrolled in the trial.||Participants|||Count of Participants
843450|NCT00858702|Secondary|Percent of Patients With Drug-related Adverse Events (Laboratory Changes in Clinical Laboratory Values)|Drug-related, laboratory value change adverse events are adverse events(AEs) as determined by the Investigator that can not be denied to be related to the study drugs. The relationship between adverse events and drugs were determined by the Investigator based on his/her clinical judgement. Factors used in determining relatedness included, but are not limited to, the medical history of the participant, use of concomitant medication, and the time course from drug administration to AE occurence.|At week 8|Safety analysis (laboratory AEs:abnormal changes in clinical laboratory values) was conducted for Safety Population. It excluded the patients who were not administered study drugs, or had no clinical laboratory data.||Percent of participants|||Number
843451|NCT00858702|Secondary|Percentage of Patients With Drug-related Adverse Events (Subjective Symptoms/Objective Findings)|Drug-related adverse events are adverse events(AEs) as determined by the Investigator that can not be denied to be related to the study drugs. The relationship between adverse events and drugs were determined by the Investigator based on his/her clinical judgement. Factors used in determining relatedness included, but are not limited to, the medical history of the participant, use of concomitant medication, and the time course from drug administration to AE occurence.|At week 8|Safety analysis (Clinical AEs:subjective symptoms / objective findings) was conducted for Safety Population. It excluded the patients who were not administrated study drugs.||Percent of participants|||Number
843452|NCT00858702|Primary|The Percentage of Patients Achieving Target Sitting Blood Pressure of Less Than 130/85||Baseline to week 8|Primary analysis was conducted for full analysis set. It excluded the patients who were not administrated study drugs, or did not satisfy entry criteria, or had no data after randomisation.||Percent of participants|||Number
843752|NCT00657709|Secondary|Geometric Mean Concentrations After Three Doses of rMenB+OMV NZ Vaccination (Against the 287-953 Antigen)|The immunogenicity was evaluated to characterize the immune response against vaccine antigen 287-953, as measured by ELISA at one month after third vaccination.|1 month after third vaccination|Analysis was done on PP dataset.||IU/mL||95% Confidence Interval|Geometric Mean
843707|NCT00681109|Secondary|Occurrence of Adverse Events||16 Weeks||||||
843708|NCT00681109|Primary|Schirmer With Anesthesia||16 Weeks||||||
843709|NCT00681109|Primary|Schirmer Without Anesthesia||16 Weeks||||||
843710|NCT00681109|Primary|Meibomian Gland Occlusion||16 Weeks||||||
843711|NCT00681109|Primary|Ocular Surface Disease Index (OSDI)|"The Ocular Surface Disease Index (OSDI) is a 12-item questionnaire designed to provide a rapid assessment of the symptoms of ocular irritation consistent with dry eye disease and their impact on vision-related functioning. The 12 items of the OSDI questionnaire are graded on a scale of 0 to 4, where 0 indicates none of the time; 1, some of the time; 2, half of the time; 3, most of the time; and 4, all of the time. The total OSDI score is then calculated on the basis of the following formula: OSDI=[(sum of scores for all questions answered) x 100]/[(total number of questions answered) x 4].
Thus, the OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability. A negative change from baseline indicated an improvement in vision-related functioning.
OSDI was assessed on the Screening Visit, Week 2, Week 6, Week 12, Week 16. Change indicated represents change from Screening to Week 12."|16 Weeks|The OSDI analysis for this study is based on a standard intention-to-treat analysis with each study participant analyzed with respect to the randomized treatment assignment, regardless of eventual compliance.||units on a scale||95% Confidence Interval|Mean
843712|NCT00681109|Primary|Conjunctival Staining Score||16 Weeks||||||
843713|NCT00681109|Primary|Cornea Staining Score||16 Weeks||||||
843714|NCT00681109|Primary|Tear Breakup Time (TBUT)||16 Weeks||||||
843715|NCT00681109|Primary|Meibomian Gland Secretion Quality||16 Weeks||||||
843751|NCT00657709|Secondary|Geometric Mean Concentrations for Antigens (Pertussis Components) for the Routine Vaccinations|Immunogenicity of the pertussis components (PT, FHA, pertactin) of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 would be considered non-inferior to that of the routine vaccines given alone if the lower limit of the two-sided CI for the ratio of GMCs one month after third vaccination.|1 month after third vaccination|Analysis was done on Immunogenicity Routine PP (Pertussis Antigens)||IU/mL||95% Confidence Interval|Geometric Mean
843746|NCT00657709|Secondary|Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine|The safety and tolerability of three doses of rMenB+OMV NZ when given concomitantly with routine infant vaccines at 2, 4 and 6 months of age was assessed by the number of subjects reporting solicited local and systemic adverse events.|upto 7 days after any vaccination|The analysis was done on safety subset population - all subjects enrolled who received study vaccination and provided post-baseline safety data.||Participants|||Number
843747|NCT00657709|Secondary|Percentage of Subjects With hSBA Titers ≥1:8|Immunogenicity was assessed in terms of the percentages of subjects achieving hSBA titers ≥1:8 at one month after third vaccination with rMenB (lot 1 or lot 2 or lot 3) against the three vaccine strains.|1 month after third vaccination|Analysis was done on PP population||Percentages of subjects||95% Confidence Interval|Number
843748|NCT00657709|Secondary|Percentages of Subjects With Fourfold Rise in hSBA Titers After Three Doses of rMenB+OMV NZ Vaccination|Immunogenicity was assessed in terms of the percentages of subjects with fourfold rise in hSBA titers after the three doses of rMenB+OMV NZ (lot 1 or lot 2 or lot 3) vaccination at 2, 4 and 6 months of age.|1 Month after third vaccination|Analysis was done on PP dataset.||Percentages of Subjects||95% Confidence Interval|Number
843749|NCT00657709|Secondary|Percentages of Subjects With Fourfold Increase in Antibody Concentrations Against the Routine Antigens|Immunogenicity was assessed in terms of the percentages of subjects with fourfold increase in antibody concentrations against the routine pertussis antigens FHA (Filamentous Hemagglutinin), Pertactin and PT (Pertussis Toxoid).|5 months|Analysis was done on PP dataset.||Percentages of Subjects||95% Confidence Interval|Number
843750|NCT00657709|Secondary|Percentages of Subjects With Antibody Response Against the Routine Antigens|"The immunogenicity of routine infant vaccines when given concomitantly with rMenB+OMV NZ at 2, 4, and 6 months of age and of the routine infant vaccines given without rMenB+OMV NZ at 1 month after third vaccination with B pertussis, diptheria and tetanus toxoid, H influenza type b, Hepatitis B antigens was measured by ELISA (Enzyme-linked immunosorbent assay) and for polio type 1, type 2 and type 3 by neutralization test (NT)(>=1:8). Diptheria and Tetanus: primary endpoint ELISA >=0.1 (international unit -IU) IU/mL and the secondary endpoint is ELISA>=1.0 IU/mL.
HepB (HBV):primary endpoint ELISA >=10 mU/mL. PRP-T: primary endpoint ≥ 0.15 mcg/mL and ≥ 1.00 mcg/mL.PNC >=0.35 mcg/ml"|1 Month after third vaccination|Analysis was done on PP population.||Percentages Of Subjects||95% Confidence Interval|Number
843753|NCT00657709|Secondary|Geometric Mean Human Serum Bactericidal Activity Titers After the Routine Vaccination Without rMenB OMV NZ|The immunogenicity was assessed in terms of prevalence of meningococcal B antibodies as measured by the hSBA, at baseline and at one month after the third vaccination, in the subjects that received routine infant vaccines without rMenB+OMV NZ.|1 Month after the third vaccination|Analysis was done on Per protocol (PP)population - All subjects who received all the relevant doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to analysis.||Titers||95% Confidence Interval|Geometric Mean
843754|NCT00657709|Secondary|The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (From 3 Lots)|The immunogenicity was evaluated to assess the consistency of the immune response from three lots of rMenB+OMV NZ in terms of percentage of subjects as measured by hSBA titer ≥1:5 when given to healthy infants at 2, 4, and 6 months of age, at 1 month after the third vaccination.|1 month after the third vaccination|Analysis was done on Per protocol (PP)population - All subjects who received all the relevant doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to analysis.||Percentages of subjects||95% Confidence Interval|Number
843755|NCT00657709|Primary|The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (3 Lots Combined)|The immunogenicity was assessed in terms of the percentages of subjects who had received the three doses of rMenB+OMV NZ (3 lots combined) given concomitantly with routine infant vaccinations and percentages of subjects who received only the routine infant vaccinations as measured by hSBA titer ≥1:5 following rMenB+OMV NZ vaccinations one month after the third vaccination is reported.|one month after the third vaccination|Analysis was done on PP population - All subjects who received all the relevant doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to analysis.||Percentages of subjects||95% Confidence Interval|Number
843756|NCT00657709|Primary|The Geometric Mean Human Serum Bactericidal Activity (hSBA) Titers After Three Doses of rMenB+OMV NZ Vaccination|The hSBA antibody titer responses, one month after receiving the third vaccination of rMenB+OMV NZ vaccination, are reported as geometric mean titers (GMTs).|one month after the third vaccination|Analysis was done on Per protocol (PP)population - All subjects who received all the relevant doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to analysis.||Titers||95% Confidence Interval|Geometric Mean
843789|NCT00605839|Primary|Quality of Parent-child Relationship|The Cornell Parent Behavior Description Scale was used to measure the antecedents and consequences of children’s perceptions of the behavior of their parents towards them. Each of 14 subscales is scored from 0-10. The potential range of the total score is therefore 0 (fewest behaviors) to 140 (most behaviors). We used the total score, which is equivalent to the sums of the subscales, and calculated the change from baseline to 6 months. The range of the change is given as a 95% CI. A change of zero would indicate no change. A positive number is a worsening , and a negative number indicates an improvement.|Change from baseline to 6 months. Please see above for a description of how the change score should be interpreted.|Everyone who completed the study||units on a scale||95% Confidence Interval|Mean
844424|NCT00320424|Secondary|Rate of Symptomatic DVT|Rate (%) was defined as number of events divided by the number of participants evaluated multiplied by 100. Signs and symptoms suggestive of VTE included, but were not limited to lower extremity DVT: erythema, warmth, pain, swelling, tenderness. Intended treatment period started 24±2 hours after surgical closure. Venogram was obtained not later than 2 calendar days after the last study drug administration (between Day 11 and 17). These events were adjudicated by the CIACE. It was evaluated from the first study drug injection up to Day 17 or to first venogram, whichever occurred first.|Up to Day 17|Safety population used.||Percentage of events/participants evalua|||Number
844425|NCT00320424|Secondary|Summary of Units Transfused|Blood product transfusions consisted of packed red blood cells or fresh frozen plasma or both. This was done between Day 2 and 2 calendar days after the last injection.|From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)|Safety population used.||mL|||Number
844426|NCT00320424|Secondary|Number of Transfused Participants|Blood product transfusions consisted of packed red blood cells or fresh frozen plasma or both. This was done between Day 2 and 2 calendar days after the last injection.|From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)|Safety population used.||Participants|||Number
844427|NCT00320424|Secondary|Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) and Death|An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.|From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)|Safety population used.||Participants|||Number
844428|NCT00320424|Secondary|Number of Participants With Minor Bleeding and Any Bleeding (Major and/or Minor Bleeding)|Minor bleeding and any bleeding (major and/or minor bleeding) events were adjudicated by the CIACS. Minor bleeding was defined as clinically overt bleeding not meeting the criteria for major bleeding and considered more than expected in the clinical context. Any bleeding (major and/or minor bleeding) could be recorded may be major and/or minor.|From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)|Safety population used.||Participants|||Number
844429|NCT00320424|Secondary|Number of Participants With Major Bleeding During Treatment Period|Major bleeding events were defined as clinically unusual bleeding meeting any of the following criteria: fatal bleeding, bleeding including retroperitoneal and intracranial bleeding or bleeding into a critical organ (eye, adrenal gland, pericardium, spine), reoperation due to bleeding/hematoma at the operative site, bleeding leading to a hemoglobin (Hb) fall >=2 grams per deciliter (g/dL, 1.6 millimoles per liter [mmol/L]) within 48 hour of the bleed, bleeding that required a transfusion of red blood cell or whole blood derived from >=900 millilters (mL) of whole blood within 48 hours of the bleed (excluding the autologous transfusion except for the treatment of bleeding adverse event (AE) and bleeding leading to the bleeding index (BI) >=2. Major bleeding events were adjudicated by the Central Independent Adjudication Committee of Safety (CIACS).|From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)|Safety population used.||Participants|||Number
844430|NCT00320424|Secondary|Rate of Distal Only DVT During Treatment Period|Rate (%) was defined as number of events divided by the number of participants evaluated multiplied by 100. Signs and symptoms suggestive of VTE included, but were not limited to lower extremity DVT: erythema, warmth, pain, swelling, tenderness. Intended treatment period started 24±2 hours after surgical closure. Venogram was obtained not later than 2 calendar days after the last study drug administration (between Day 11 and 17). These events were adjudicated by the CIACE. It was evaluated from the first study drug injection up to Day 17 or to first venogram, whichever occurred first.|Up to Day 17|Efficacy evaluable participants used. Only those participants with data available at the indicated time points were analyzed.||% of events/participants evaluated|||Number
844431|NCT00320424|Secondary|Rate of Proximal DVT During Treatment Period|Rate (%) was defined as number of events divided by the number of participants evaluated multiplied by 100. Signs and symptoms suggestive of VTE included, but were not limited to lower extremity DVT: erythema, warmth, pain, swelling, tenderness. Intended treatment period started 24±2 hours after surgical closure. Venogram was obtained not later than 2 calendar days after the last study drug administration (between Day 11 and 17). These events were adjudicated by the CIACE. It was evaluated from the first study drug injection up to Day 17 or to first venogram, whichever occurred first.|Up to Day 17|Efficacy evaluable participants used. Only those participants with data available at the indicated time points were analyzed.||% of events/participants evaluated|||Number
844432|NCT00320424|Secondary|Rate of DVT During Treatment Period|Rate (%) was defined as number of events divided by the number of patients evaluated multiplied by 100. Signs and symptoms suggestive of VTE included, but were not limited to lower extremity DVT: erythema, warmth, pain, swelling, tenderness. Intended treatment period started 24±2 hours after surgical closure. Venogram was obtained not later than 2 calendar days after the last study drug administration (between Day 11 and 17). These events were adjudicated by the CIACE. It was evaluated from the first study drug injection up to Day 17 or to first venogram, whichever occurred first.|Up to Day 17|Efficacy evaluable participants used consisted of a subpopulation of safety population who were judged to be evaluable for all DVT and proximal DVT or distal only DVT by the site of occurrence (total/side of operation/opposite side of operation/both sides). Only those participants with data available at the indicated time points were analyzed.||% of events/participants evaluated|||Number
844433|NCT00320424|Secondary|Rate of PE During Treatment Period|Rate (%) was defined as number of events divided by the number of participants evaluated multiplied by 100. Signs and symptoms suggestive of VTE included, but were not limited to lower extremity PE: pleuritic chest pain, dyspnea, cough, hemoptysis, syncope, light-headedness/dizziness, tachypnea, and tachycardia. Intended treatment period started 24±2 hours after surgical closure. Venogram was obtained not later than 2 calendar days after the last study drug administration (between Day 11 and 17). These events were adjudicated by the CIACE. It was evaluated from the first study drug injection up to Day 17 or to first venogram, whichever occurred first.|Up to Day 17|Safety population used which consisted of all participants who received at least one dose of study drug.||% of events/participants evaluated||95% Confidence Interval|Number
844434|NCT00320424|Primary|Rate of Major Bleeding During Treatment Period|Rate (%) was defined as number of events divided by the number of participants evaluated multiplied by 100. Signs and symptoms suggestive of VTE included, but were not limited to lower extremity DVT: erythema, warmth, pain, swelling, tenderness and PE: pleuritic chest pain, dyspnea, cough, hemoptysis, syncope, light-headedness/dizziness, tachypnea, and tachycardia. Intended treatment period started 24±2 hours after surgical closure. Venogram was obtained not later than 2 calendar days after the last study drug administration (between Day 11 and 17). These events were adjudicated by the Central Independent Adjudication Committee of Efficacy (CIACE).|From the first study drug injection up to Day 17|Full analysis set used which consisted of all participants who were assigned to study drug with the exception of those who did not receive study drug at all and those with no valid efficacy data (example no evaluable venogram).||% of events/participants evaluated||95% Confidence Interval|Number
844494|NCT00250484|Secondary|Cognitive Assessment - Neuropsychological Battery|"Beck Depression Inventory (BDI), and Visual Analog Scale (VAS) for anxiety were assessed in subjects both as a baseline score before treatment was initiated as and upon conclusion of treatment.
BDI is a 0-63 scale increasing with depression severity. A score from 0-13 indicates minimal depression, 14-19 indicates mild depression, 20-28 indicates moderate depression, and 28-63 indicates severe depression. Higher values represent a worse outcome.
VAS is a pain assessment ranging from 0-10 increasing with pain severity. High values represent a worse outcome."|Baseline and end of treatment at approximately 1 year|||units on a scale||Standard Deviation|Mean
844493|NCT00250484|Secondary|Medication Use (Medication Diary)|Data was not collected or recorded because this outcome measure was no longer considered useful or relevant in the study.|Baseline and end of treatment at approximately 1 year|Data was not collected. Data was not collected or recorded because this outcome measure was no longer considered useful or relevant in the study.|||||
844495|NCT00250484|Primary|Pain (Visual Analog Scale, CGI, PGA)|Pain intensity and therefore changes in pain intensity were assessed using a 0-10 Visual Analog Scale where 0 represents the least amount of pain and 10 is the most pain imaginable. The pain evaluation was carried out by a blinded rater based off 1) baseline evaluation: 3 week long pain logs and a diary of pain medication intake, 2) treatment evaluations: participants were also asked to fill out daily pain logs following each TMS session and to keep a diary of pain medications during the CRC stay for the TMS course and 3)follow-up evaluation: finally, there was a follow up measurement 3 weeks after treatment.|1 year|||number of participants w/ reduced pain|||Number
844739|NCT00083174|Secondary|Incidences of Other Malignancies|Other malignancies includes any other malignancy which is not in breast.|Over study (median follow-up 35 months)|Women who have received treatment||participants|||Number
844740|NCT00083174|Secondary|Incidence of Clinically Relevant Cardiac Events|Events including myocardial infarctions and angina requiring percutaneous transluminal coronary angioplasty or coronary artery bypass graft, fatal and nonfatal strokes and all vascular deaths|During protocol treatment (up to 5 years)|Women who received treatment||participants|||Number
844741|NCT00083174|Secondary|Incidence of All Clinical Fractures||During protocol treatment (up to 5 years)|Women who have received treatment||participants|||Number
844742|NCT00083174|Secondary|Number of Clinical Breast Biopsies||Over study (median follow-up 35 months)|Women who had at least one clinical breast biopsy||number of clinical breast biopsies||Full Range|Median
844743|NCT00083174|Secondary|Incidence of Lobular Carcinoma in Situ, Atypical Ductal Hyperplasia and Atypical Lobular Hyperplasia Events||Over study (median follow-up 35 months)|Intent-to-treat (ITT)||percentage of cases/follow-up person-yr||95% Confidence Interval|Number
844744|NCT00083174|Secondary|Total Incidence of Invasive and Non-invasive (DCIS) Breast Cancer|It was estimated from the Total Breast Cancer-Free Survival (TBCFS), which was calculated for women who developed invasive or non-invasive (DCIS) breast cancer as the time from the date of randomization to the earliest date of diagnosis for invasive or non-invasive (DCIS) breast cancer. Women who died from other causes were censored at the time of death. Women who had breast cancer before entry were censored at the time of randomization. If a woman did not develop an invasive or non-invasive (DCIS) breast cancer, or died, TBCFS will be censored on the date of last known alive.|Over study (median follow-up 35 months)|Intent-to-treat (ITT)||percentage of cases/follow-up person-yr||95% Confidence Interval|Number
844745|NCT00083174|Primary|Invasive Breast Cancer Incidence (Breast Cancer-Free Survival)|Invasive breast cancer incidence was estimated from the breast cancer-free survival (BCFS) which was calculated for all women from the day of the randomization to the earliest date of diagnosis for invasive breast cancer. Women who died from other causes were censored at the time of death. If a woman did not develop an invasive breast cancer, or died, BCFS was censored on the date of the last day the woman was known alive (LKA), which was the latest of the date of assessment. Women who had breast cancer before study entry were also censored at the time of randomization.|Over study (median follow-up 35 months)|intention to treat (ITT)||percentage of cases/follow-up person-yr||95% Confidence Interval|Number
844746|NCT00083174|Primary|Frequency of Serious Adverse Events|Frequency of serious adverse events for women who choose to receive 5 years of exemestane as preventative therapy.|5 years||||||
844760|NCT00066573|Secondary|Cardiovascular Morbidity and Mortality||8 years||||||
844761|NCT00066573|Secondary|Clinical Fracture Rate||8 years||||||
844762|NCT00066573|Secondary|New Primary Breast Cancer||8 years||||||
844763|NCT00066573|Secondary|Distant Disease-free Survival||8 years||||||
844764|NCT00066573|Secondary|Overall Survival||8 years||||||
844765|NCT00066573|Primary|Event-free Survival|Event free survival, the primary endpoint of this study, is defined as the time from randomization to the time of documented locoregional or distant recurrence, new primary breast cancer, or death from any cause.|5 years|||percentage of participants||95% Confidence Interval|Number
845890|NCT03073798|Primary|Difference in Mucociliary Clearance (MCC) Between Visit 1B and Visit 2B|"Measurements of MCC (Mucociliary clearance) will be obtained using a large-field-of-view 2D gamma camera (Siemens Orbiter) following inhalation of a radioaerosol containing a gamma emitting isotope 99mtechnetium (99mTc)-sulfur-colloid. The total exposure to radiation from procedures associated with the MCC studies is similar to that of a chest x-ray and is much less than the 0.3 rem that the average person in the United States gets each year from natural sources like the sun, outer space, air, food, and soil.
After inhaling (0 time point) an aerosol generated from a saline solution containing the radioisotope 99mtechnetium (99mTc)-sulfur-colloid (radioaerosol), subjects will sit with their back to a gamma camera. The gamma camera will acquire an image of where the isotopic marker initially deposits in the right lung at time 0 and how much remains in the lungs at the specified time point and will be measured in change of %/min from 0 min time point."|Change from 0 min to 24 hours|Data was not collected for all participants in this outcome measure due to lack of follow-up, patient withdrawal from the study, and an adverse event.||percentage difference of MCC||Standard Deviation|Mean
845891|NCT03073798|Primary|Difference in Mucociliary Clearance (MCC) Between Visit 1A and Visit 2A|"Measurements of MCC (Mucociliary clearance) will be obtained using a large-field-of-view 2D gamma camera (Siemens Orbiter) following inhalation of a radioaerosol containing a gamma emitting isotope 99mtechnetium (99mTc)-sulfur-colloid. The total exposure to radiation from procedures associated with the MCC studies is similar to that of a chest x-ray and is much less than the 0.3 rem that the average person in the United States gets each year from natural sources like the sun, outer space, air, food, and soil.
After inhaling (0 time point) an aerosol generated from a saline solution containing the radioisotope 99mtechnetium (99mTc)-sulfur-colloid (radioaerosol), subjects will sit with their back to a gamma camera. The gamma camera will acquire an image of where the isotopic marker initially deposits in the right lung at time 0 and how much remains in the lungs at the specified time point and will be measured in change of %/min from 0 min time point."|Change from 0 to 90 minutes|Data was not collected for all participants in this outcome measure due to lack of follow-up, patient withdrawal from the study, and an adverse event.||percentage difference of MCC||Standard Deviation|Mean
845892|NCT03073798|Primary|Difference in Mucociliary Clearance (MCC) Between Visit 1A and Visit 2A|"Measurements of MCC (Mucociliary clearance) will be obtained using a large-field-of-view 2D gamma camera (Siemens Orbiter) following inhalation of a radioaerosol containing a gamma emitting isotope 99mtechnetium (99mTc)-sulfur-colloid. The total exposure to radiation from procedures associated with the MCC studies is similar to that of a chest x-ray and is much less than the 0.3 rem that the average person in the United States gets each year from natural sources like the sun, outer space, air, food, and soil.
After inhaling (0 time point) an aerosol generated from a saline solution containing the radioisotope 99mtechnetium (99mTc)-sulfur-colloid (radioaerosol), subjects will sit with their back to a gamma camera. The gamma camera will acquire an image of where the isotopic marker initially deposits in the right lung at time 0 and how much remains in the lungs at the specified time point and will be measured in change of %/min from 0 min time point."|Change from 0 to 60 minutes|Data was not collected for all participants in this outcome measure due to lack of follow-up, patient withdrawal from the study, and an adverse event.||percentage difference of MCC||Standard Deviation|Mean
845893|NCT03073798|Primary|Difference in Mucociliary Clearance (MCC) Between Visit 1A and Visit 2A|"Measurements of MCC (Mucociliary clearance) will be obtained using a large-field-of-view 2D gamma camera (Siemens Orbiter) following inhalation of a radioaerosol containing a gamma emitting isotope 99mtechnetium (99mTc)-sulfur-colloid. The total exposure to radiation from procedures associated with the MCC studies is similar to that of a chest x-ray and is much less than the 0.3 rem that the average person in the United States gets each year from natural sources like the sun, outer space, air, food, and soil.
After inhaling (0 time point) an aerosol generated from a saline solution containing the radioisotope 99mtechnetium (99mTc)-sulfur-colloid (radioaerosol), subjects will sit with their back to a gamma camera. The gamma camera will acquire an image of where the isotopic marker initially deposits in the right lung at time 0 and how much remains in the lungs at the specified time point and will be measured in change of %/min from 0 min time point."|Change from 0 to 30 minutes|Data was not collected for all participants in this outcome measure due to lack of follow-up, patient withdrawal from the study, and an adverse event.||percentage difference of MCC||Standard Deviation|Mean
845949|NCT02294461|Secondary|Number of Participants With Adverse Events|The Treatment-Emergent Adverse Events are defined as AEs with a possible or probable relationship to study drug. If participant was still on study drug at the analysis data cutoff date, then the length of the treatment-emergent period was calculated through the cutoff date.|From first dose of study drug up to data cut off date of 20 Sept 2015|Safety Analysis Set consisted of all randomized participants who received at least 1 dose of study drug.||Participants|||Number
845950|NCT02294461|Secondary|AUC From the Time of Dosing to the Start of the Next Dosing Interval (AUCtau) Enzalutamide, M1,M2 and Enzalutamide Plus M2||From randomization up to data cutoff date of 20 Jan 2016; Multiple Dosing Day 85|The Pharmacokinetic Analysis Set (PKAS) population consisted of all participants who received at least 1 dose of study drug and who provided blood samples for drug concentrations at at least 1 time point.||μg·h/mL||Standard Deviation|Mean
845951|NCT02294461|Secondary|Peak-Trough Ratio (PTR) Enzalutamide, M1,M2 and Enzalutamide Plus M2||From randomization up to data cutoff date of 20 Jan 2016; Multiple Dosing Day 85|The Pharmacokinetic Analysis Set (PKAS) population consisted of all participants who received at least 1 dose of study drug and who provided blood samples for drug concentrations at at least 1 time point.||Ratio||Standard Deviation|Mean
845952|NCT02294461|Secondary|Apparent Total Systemic Clearance After Multiple Dosing (CL/F) Enzalutamide, M1,M2 and Enzalutamide Plus M2 (For Unchanged Enzalutamide Only)||From randomization up to data cutoff date of 20 Jan 2016; Multiple Dosing Day 85|The Pharmacokinetic Analysis Set (PKAS) population consisted of all participants who received at least 1 dose of study drug and who provided blood samples for drug concentrations at at least 1 time point.||L/h||Standard Error|Mean
845953|NCT02294461|Secondary|Observed Plasma Concentration in Predose Samples Obtained During Multiple-dose Administration of Minimum Concentration (Plasma Concentration at Pre Dose) (Cmin) Enzalutamide, M1,M2 and Enzalutamide Plus M2|N is the number of participants with available data at this time point.|From randomization up to data cutoff date of 20 Jan 2016; Day 2, 3, 8, 22, 29, 43, 57, 85, 86, 113, 141 and 169|The Pharmacokinetic Analysis Set (PKAS) population consisted of all participants who received at least 1 dose of study drug and who provided blood samples for drug concentrations at least 1 time point.||μg/mL||Standard Deviation|Mean
845954|NCT02294461|Secondary|Concentration 24 h After Dosing (C24h) Enzalutamide, M1,M2 and Enzalutamide Plus M2|N is the number of participants with available data at this time point.|From randomization up to data cutoff date of 20 Jan 2016; Single Dosing Day 1 and Multiple Dosing Day 85|The Pharmacokinetic Analysis Set (PKAS) population consisted of all participants who received at least 1 dose of study drug and who provided blood samples for drug concentrations at at least 1 time point.||μg/mL||Standard Deviation|Mean
845955|NCT02294461|Secondary|AUC From the Time of Dosing to 24 h After Dosing (AUC24h) Enzalutamide, M1,M2 and Enzalutamide Plus M2||From randomization up to data cutoff date of 20 Jan 2016; Single Dosing Day 1|The Pharmacokinetic Analysis Set (PKAS) population consisted of all participants who received at least 1 dose of study drug and who provided blood samples for drug concentrations at at least 1 time point. Number of participants analyzed is the number of participants with available data at this time point.||μg·h/mL||Standard Deviation|Mean
845956|NCT02294461|Secondary|Maximum Observed Plasma Concentration During the First 24 Hours After Dosing (Cmax) Enzalutamide, M1,M2 and Enzalutamide Plus M2||From randomization up to data cutoff date of 20 Jan 2016; Single Dosing Day 1 and Multiple Dosing Day 85|The Pharmacokinetic Analysis Set (PKAS) population consisted of all participants who received at least 1 dose of study drug and who provided blood samples for drug concentrations at at least 1 time point.||μg/mL||Standard Deviation|Mean
845957|NCT02294461|Secondary|Time to Maximum Concentration (Tmax) of Enzalutamide, M1,M2 and Enzalutamide Plus M2||From randomization up to data cutoff date of 20 Jan 2016; Single Dosing Day 1 and Multiple Dosing Day 85|The Pharmacokinetic Analysis Set (PKAS) population consisted of all participants who received at least 1 dose of study drug and who provided blood samples for drug concentrations at at least 1 time point.||(h)||Full Range|Median
845958|NCT02294461|Secondary|Best Overall Soft Tissue Response|Participants with measurable soft tissue disease at screening visit (i.e., at least one target lesion per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) who have an objective response (complete response (CR) or partial response (PR)) during the study were included in the best overall soft tissue response assessment. The best overall soft tissue response was based on the investigator assessment using RECIST 1.1.|From randomization up to data cut off date of 20 Sept 2015; median treatment duration is 6.60 months for enzalutamide and 3.70 months for placebo|The Intent-to-Treat (ITT) population consisted of all randomized participants in the study.||Participants|||Number
845959|NCT02294461|Secondary|Number of Participants With Confirmed Best PSA Response (≥50% Decrease From Baseline)|Best PSA response was defined as as ≥50% reductions in PSA level from baseline to the lowest post-baseline PSA result as determined by the central laboratory, with a consecutive assessment conducted at least 3 weeks later to confirm the PSA response. Only participants who had both baseline and post-baseline assessments were included in the analysis.|Baseline up to data cut off date of 20 Sept 2015; median treatment duration is 6.60 months for enzalutamide and 3.70 months for placebo|The Intent-to-Treat (ITT) population consisted of all randomized participants in the study.||Participants|||Number
845960|NCT02294461|Secondary|Time to Initiation of Cytotoxic Chemotherapy|Time to initiation of cytotoxic chemotherapy was defined as the time from randomization to initiation of cytotoxic chemotherapy. It included only therapies for prostate cancer. When multiple cytotoxic chemotherapies were initiated, the first chemotherapy was used to determine the time to event. Participants who did not start cytotoxic chemotherapy at the time of analysis data cutoff were censored at the date of their last assessment indicating no evidence of cytotoxic chemotherapy usage.|From randomization up to data cutoff date of 20 Sept 2015; median follow-up time is 7.39 months for enzalutamide and 4.93 months for placebo|The Intent-to-Treat (ITT) population consisted of all randomized participants in the study.||Months||95% Confidence Interval|Median
845961|NCT02294461|Secondary|Time to First Skeletal-Related Event|Time to first skeletal-related event (SRE) was defined as the time from randomization to the first skeletal-related event, defined as radiation therapy or surgery to bone, pathologic bone fracture, spinal cord compression, or change of anti-neoplastic therapy to treat bone pain. Participants who have not had a SRE at the time of the analysis were censored at their last assessment indicating no evidence of SRE.|From randomization up to data cutoff date of 20 Sept 2015; median follow-up time is 7.39 months for enzalutamide and 5.29 months for placebo|The Intent-to-Treat (ITT) population consisted of all randomized participants in the study.||Months||95% Confidence Interval|Median
845962|NCT02294461|Secondary|Duration of Radiographic Progression-free Survival (rPFS) Based on Independent Central Review Facility Assessment|"Duration of Radiographic Progression-free Survival (rPFS) was defined as the time from randomization to the rPFS event (deaths from any cause and radiographic disease progression). Radiographic disease progression is defined by RECIST 1.1 for soft tissue disease, or PCWG2 for bone lesions.
If a participant met the criteria for more than 1 censoring rule, they were censored with the earliest censoring date. The radiographic progression date was the first date when progression definition was met, not confirmed."|From randomization up to data cutoff date of 20 Sept 2015; median follow-up time is 5.55 months for enzalutamide and 3.71 months for placebo|Intent-to-Treat (ITT) population consisted of all randomized participants in the study.||Months||95% Confidence Interval|Median
845963|NCT02294461|Secondary|Duration of Overall Survival|Duration of overall survival was defined as the time from the randomization to deaths from any cause. For participants who were alive at the time of the data analysis, overall survival time was censored to the last know date the participants were known to be alive or data analysis cutoff date, whichever occurred first.|From randomization up to data cutoff date of 20 Sept 2015; median follow-up time is 8.02 months for enzalutamide and 5.55 months for placebo|The Intent-to-Treat (ITT) population consisted of all randomized participants in the study.||Months||95% Confidence Interval|Median
845964|NCT02294461|Primary|Time to Prostate-specific Antigen (PSA) Progression|The time to Prostate Specific Antigen (PSA) progression was defined as the time from randomization to the PSA progression. The PSA progression was defined according to the consensus guidelines of Prostate Cancer Clinical Trials Working Group 2 (PCWG2).For participants with PSA decline at Week 13, the PSA progression date was defined as a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the nadir, which would be confirmed by a second consecutive value obtained 3 or more weeks later. For participants with no PSA decline at Week 13, the PSA progression date was defined as the date when a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the baseline was documented, which was confirmed by a second consecutive value 3 or more weeks later. PSA progression at the time of the data analysis cutoff date could only be declared on or after the week 13.Time to PSA progression was estimated using the Kaplan-Meier method. Participants without confirmed PSA progression were censore|From randomization up to data cut off date of 20 Sept 2015; median follow-up time is 7.33 months for enzalutamide and 3.02 months for placebo|The Intent-to-Treat (ITT) population consisted of all randomized participants in the study.||Months||95% Confidence Interval|Median
845965|NCT02218697|Secondary|Number of Subjects Whose N Antibody Titers Were at Least 2 or 4-fold Higher Than Their Pre-vaccination Titer by Anti-pneumococcal Serotype Subjects.|"Fold antibody concentration increases post-vaccination/pre-vaccination ≥ 2 and ≥ 4.
The anti-pneumococcal serotypes assessed were 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F."|At 28 days post-vaccination with Pneumovax™ 23|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.||Subjects|||Number
845966|NCT02218697|Secondary|Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 12 Pneumococcal Serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F)|"Anti-pneumococcal antibody concentrations were expressed as adjusted geometric mean concentrations (GMCs) PRE = Pre -vaccination i.e. at Day 0 for Co-Ad Group and at Day 28 for Control Group.
POST = Post-vaccination i.e. at Day 28 for Co-Ad Group and at Day 56 for Control Group."|At Days 0 (Co-Ad group only), 28 (both groups), and 56 (Control group only)|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.||Titers||95% Confidence Interval|Geometric Mean
845967|NCT02218697|Secondary|Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F|"The pneumococcal antigen testing was performed, as determined by ELISA cut-offs of ≥0.05 µg/mL and a seroprotection cut-off of ≥ 0.2 µg/ml.
PRE = Pre-vaccination i.e. at Day 0 for Co-Ad Group and at Day 28 for Control Group.
POST = Post-vaccination i.e. at Day 28 for Co-Ad Group and at Day 56 for Control Group."|At Days 0 (Co-Ad group only), 28 (both groups), and 56 (Control group only)|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.||Subjects|||Number
845968|NCT02218697|Secondary|Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains.|MGI was defined as the fold increase in serum haemagglutination inhibition (HI) GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Brisbane/60/2008 (Victoria) and Flu B/Massachusetts/02/2012 (Yamagata).|At Day 28|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.||Fold increase||95% Confidence Interval|Geometric Mean
845969|NCT02218697|Secondary|Number of Seroconverted Subjects for Anti-Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains.|A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Brisbane/60/2008 (Victoria) and Flu B/Massachusetts/02/2012 (Yamagata).|At Day 28|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.||Subjects|||Number
845970|NCT02218697|Secondary|Number of Subjects Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains.|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Brisbane/60/2008 (Victoria) and Flu B/Massachusetts/2/2012 (Yamagata).|At Day 0 and Day 28|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.||Subjects|||Number
845971|NCT02218697|Secondary|Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Influenza Vaccine Strains|HI antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Brisbane/60/2008 (Victoria) and Flu B/Massachusetts/02/2012 (Yamagata).|At Day 0 and Day 28|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.||Titers||95% Confidence Interval|Geometric Mean
845972|NCT02218697|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|Throughout the study period (Days 0-180)|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.||Subjects|||Number
845973|NCT02218697|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|Within the 28-day (Days 0-27) post-vaccination period|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.||Subjects|||Number
845974|NCT02218697|Secondary|Number of Subjects Reporting the Occurrence of Potential Immune Mediated Diseases (pIMDs)|"Potential immune-mediated diseases (pIMDs) were defined as a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Any was defined as any occurrence of pIMD(s) regardless of intensity grade or relationship to vaccination. Related was defined as pIMD assessed by the investigator to be causally related to the study vaccination."|During the entire study period (Days 0-180)|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.||Subjects|||Number
845975|NCT02218697|Secondary|Number of Subjects Reporting the Occurrence of Medically Attended Adverse Events (MAEs)|MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s) regardless of intensity grade or relationship to vaccination. Related was defined as MAE assessed by the investigator to be causally related to the study vaccination.|Throughout the study period (Days 0-180)|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.||Subjects|||Number
845976|NCT02218697|Secondary|Duration of Solicited General AEs.|Duration was defined as number of days with any grade of general symptoms.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.||Days||Full Range|Median
845977|NCT02218697|Secondary|Duration of Local Adverse Events|Duration was defined as number of days with any grade of local symptoms.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.||Days||Full Range|Median
845978|NCT02218697|Secondary|Number of Subjects Reporting Solicited General Adverse Events (AEs)|"Solicited general symptoms assessed were fatigue, gastrointestinal symptoms*, headache, joint pain, muscle aches, shivering, sweating and fever. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Grade 3 was defined as symptoms that prevented normal everyday activities. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 fever was defined as temperature greater than (>)39.0°C.
*Gastrointestinal (GI) symptoms included nausea, vomiting, diarrhoea and/or abdominal pain"|Within 7 days (Days 0 - 6) after each dose and across doses.|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.||Subjects|||Number
845979|NCT02218697|Secondary|Number of Subjects Reporting Solicited Local Adverse Events (AEs)|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain = significant pain at rest and pain that prevented normal everyday activities. Grade 3 redness and swelling = greater than 50 millimeters (mm) i.e. > 100mm.|Within 7 days (Days 0 - 6) after each dose and across doses.|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.||Subjects|||Number
845980|NCT02218697|Primary|Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 6 Pneumococcal Serotypes (1, 3, 4, 7F, 14 and 19A).|Anti-pneumococcal antibody concentrations were expressed as adjusted geometric mean concentrations (GMCs) and adjusted GMC ratio (Control Group/Co-Ad Group).|At 28 days after Pneumovax™ 23 vaccination|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.||ug per ml||95% Confidence Interval|Geometric Mean
845981|NCT02218697|Primary|Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies Titers Against the 4 Vaccine Strains.|HI antibody titres were expressed as geometric mean titers (GMTs) and adjusted GMT ratios (Control Group/Co-Ad Group). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), FluA/Texas/50/2012 (H3N2), Flu B/Brisbane/60/2008 (Victoria) and Flu B/Massachusetts/2/2012 (Yamagata).|At Day 28 post Influsplit™ Tetra vaccination|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.||Titers||95% Confidence Interval|Geometric Mean
846042|NCT02164929|Secondary|Time to First Ingestion of Solid Food||Participants will be followed for the duration of hospital stay, an estimated 1 week|||Days||Standard Deviation|Mean
846007|NCT02189837|Secondary|Percent Change From Baseline in Lipoprotein(a) Production Rate (PR)|The production rate of lipoprotein(a) was measured at Baseline and Day 50 over 5 consecutive days using the stable isotope tracer, D3-leucine. Lp(a) was isolated from plasma using an immunoprecipitation method employing immunomagnetic beads and polyacrylamide gel electrophoresis. Isotopic enrichment was determined using gas chromatography-mass spectrometry. Mathematical modelling of the protein enrichment data was used to estimate protein catabolism.|Baseline and Day 50|Efficacy Analysis Set with available data||percent change||Standard Error|Least Squares Mean
846008|NCT02189837|Secondary|Percent Change From Baseline in Lipoprotein (a) Fractional Catabolic Rate (FCR)|The fractional catabolic rate (the percentage of lipoprotein(a) (Lp[a]) which is replaced, transferred or lost per unit of time) was measured at Baseline and Day 50 over 5 consecutive days using the stable isotope tracer, D3-leucine. Lp(a) was isolated from plasma using an immunoprecipitation method employing immunomagnetic beads and polyacrylamide gel electrophoresis. Isotopic enrichment was determined using gas chromatography-mass spectrometry. Mathematical modelling of the protein enrichment data was used to estimate protein catabolism.|Baseline (5 days prior to Day 1) and Day 50; plasma samples for fasting lipids were obtained at 0, 5, 10, 20, 30, 40, and 60 min, as well as at 1.5, 2, 2.5, 3, 4, 5, 6, 8, and 10 hours, and 2, 3, 4 and 5 days after D3-leucine administration.|Efficacy Analysis Set with available data||percent change||Standard Error|Least Squares Mean
846009|NCT02189837|Secondary|Percent Change From Baseline in LDL Apolipoprotein B-100 Production Rate (PR)|The production rate of apolipoprotein B-100 in LDL was measured at Baseline and Day 50 over 5 consecutive days using the stable isotope tracer, D3-leucine. LDL particles were isolated from plasma by sequential ultracentrifugation and isotopic enrichment was determined using gas chromatography-mass spectrometry. Mathematical modelling of the protein enrichment data was used to estimate the production rate.|Baseline and Day 50|Efficacy Analysis Set||percent change||Standard Error|Least Squares Mean
846010|NCT02189837|Secondary|Percent Change From Baseline in LDL-C at Day 50|LDL-C was measured using ultrcentrifugation.|Baseline and Day 50|Efficacy Analysis Set with available data at both time points||percent change||Standard Error|Least Squares Mean
846011|NCT02189837|Primary|Percent Change From Baseline in Low-density Lipoprotein (LDL) Apolipoprotein B-100 Fractional Catabolic Rate (FCR)|The fractional catabolic rate (the percentage of apolipoprotein B-100 in LDL which is replaced, transferred or lost per unit of time) was measured at Baseline and Day 50 over 5 consecutive days using the stable isotope tracer, D3-leucine. LDL particles were isolated from plasma by sequential ultracentrifugation, and isotopic enrichment was determined using gas chromatography-mass spectrometry. Mathematical modelling of the protein enrichment data was used to estimate protein catabolism.|Baseline (5 days prior to Day 1) and Day 50; plasma samples for fasting lipids were obtained at 0, 5, 10, 20, 30, 40, and 60 min, as well as at 1.5, 2, 2.5, 3, 4, 5, 6, 8, and 10 hours, and 2, 3, 4 and 5 days after D3-leucine administration.|Efficacy Analysis Set including all randomized and dosed participants who completed baseline and Day 50 measurements.||percent change||Standard Error|Least Squares Mean
846043|NCT02164929|Secondary|Opioid Related Side Effects|Occurrence and duration of opioid related adverse events including postoperative nausea and vomiting (PONV); pruritus, urinary retention, confusion, sedation and respiratory depression at the above time points.|Participants will be followed for the duration of hospital stay, an estimated 1 week|||side effects|||Number
846044|NCT02164929|Secondary|Time to First Bowel Movement||Participants will be followed for the duration of hospital stay, an estimated 1 week|||days||Standard Deviation|Mean
846045|NCT02164929|Secondary|Complications as Measured by a Modified Postoperative Morbidity Survey (MPMS)|Complications using a Modified Postoperative Morbidity Survey (MPMS)|Participants will be followed for the duration of hospital stay, an estimated 1 week|Data not collected|||||
846046|NCT02164929|Secondary|Quality of Recovery|Quality of Recovery Score (QoR-15) is measured on a scale of 0-150 (0=poor, 150 = excellent). Scores were collected daily for 72 hours and then averaged.|72 hours|||Units on a scale||Standard Deviation|Mean
846036|NCT02179892|Secondary|Mean Time of First Opioid Use|The time of first opioid use after surgery will be recorded for up to 72 hours.|Post-surgery (Up to 72 Hours)|||hours||Standard Deviation|Mean
846037|NCT02179892|Secondary|Mean Visual Analogue Scale (VAS) Pain Score With Movement|The VAS method of pain assessment (scale of 1-10) will be used to measure the patient's level of pain with movement each day during the 72 hour post surgical period. One represents the lowest level of pain and 10 represents the highest level of pain.|Post-Surgery 24 Hours, 48 Hours, 72 Hours|||units on a scale||Standard Deviation|Mean
846038|NCT02179892|Secondary|Mean Visual Analogue Scale (VAS) Pain Score at Rest|The VAS method of pain assessment (scale of 1- 10) will be used to measure the participant's pain level at rest each day during the 72 hours post surgical period. One represents the lowest level of pain and 10 represents the highest level of pain.|Post-Surgery 24 Hours, 48 Hours, 72 Hours|||units on a scale||Standard Deviation|Mean
846039|NCT02179892|Primary|Mean Opioid Consumption|The investigators will collect the total amount of opioid consumption for the 72 hour post operative period in each group.|Post Surgery (Up to 72 Hours)|||milligrams||Standard Deviation|Mean
846040|NCT02164929|Secondary|Length of Stay||Participants will be followed for the duration of hospital stay, an estimated 1 week|||Days||Standard Deviation|Mean
846041|NCT02164929|Secondary|Number of Epidural-related Side Effects||Participants will be followed for the duration of hospital stay, an estimated 1 week|||Number of side effects|||Number
846047|NCT02164929|Secondary|Pain Scores|"Pain scores at rest and with activity using a verbal rating scales (VRS) of 0-10, where 0 represents no pain and 10 represents worst pain ever, at 30, 60, 90, 120 min and every 6 hours for 24 hours and every 12 hours for 48 hours and once a day thereafter until discharge. Data were collected at the indicated time points and an average pain score was calculated."|Participants will be followed for the duration of hospital stay, an estimated 1 week|||Units on a scale||Standard Deviation|Mean
846048|NCT02164929|Primary|Postoperative Opioid Consumption|If opioid other than fentanyl is used, the dose will be converted to morphine equivalent.|24 hours after surgery|||mcg||Standard Deviation|Mean
846049|NCT02164318|Secondary|Count of Participants Using Their AVF for Dialysis|Successful use of AVF at 12 months in dialysis dependent patients. Not relevant in participants that are predialysis or that discontinue dialysis prior to AVF use.|12 months post surgery|Only subjects who were on dialysis at 12 months are included in the analysis. Only 5 participants were on dialysis at this time.||Participants|||Count of Participants
846050|NCT02164318|Secondary|Count of Participants With a Patent Fistula|Determination that AVF is patent (has blood flow, no occlusion).|3 months post surgery|Two subjects withdrew from this study prior to their AVF surgery, therefore they were not included in the analysis population.||Participants|||Count of Participants
846051|NCT02164318|Primary|Count of Participants With Mature Arteriovenous Fistula (AVF)|Use of AVF for dialysis for dialysis dependent participants, or fistula deemed mature based on physical exam in predialysis participants (diameter >6 mm, blood flow >600 ml by ultrasound or estimated by physical exam).|3 month post surgery to create AVF|Two subjects withdrew from this study prior to their AVF surgery, therefore they were not included in the analysis population.||Participants|||Count of Participants
846082|NCT02046148|Secondary|Birth Length and Head Circumference of Infants (Mean - Standard Deviation)|Length and head circumference at birth were summarized by reporting the mean and standard deviation.|At Birth|Infants born to screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID and who received a study vaccination.||Centimeter||Standard Deviation|Mean
847367|NCT00607126|Secondary|Distance|distance assessed by 6 minute walk test|baseline, mid point, end and 12 weeks after training|||feet||Standard Deviation|Mean
846077|NCT02046148|Secondary|Descriptive Statistics for the Score for the Long-term Developmental Outcome Assessed by Bayley Scales of Infant and Toddler Development 3rd Edition Screening Test (PsychCorp) in Infants (Median, Minimum and Maximum)|"Long-term developmental outcome assessed by Bayley Scales of Infant and Toddler Development 3rd edition Screening Test (PsychCorp). The screening test measured three domains: cognitive, language (receptive vs expressive communication), and motor (fine vs gross).
Scaled scores range from 1 to 19 with a mean of 10 and a standard deviation of 3. The scores were summarized by reporting the median, minimum and maximum."|At Day 180 of age|Infants born to screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID and who received a study vaccination.||Sores on a scale||Full Range|Median
846078|NCT02046148|Secondary|Descriptive Statistics for the Score for the Long-term Developmental Outcome Assessed by Bayley Scales of Infant and Toddler Development 3rd Edition Screening Test (PsychCorp) in Infants (Mean - Standard Deviation)|"Long-term developmental outcome assessed by Bayley Scales of Infant and Toddler Development 3rd edition Screening Test (PsychCorp). The screening test measured three domains: cognitive, language (receptive vs expressive communication), and motor (fine vs gross).
Scaled scores range from 1 to 19 with a mean of 10 and a standard deviation of 3. The scores were summarized by reporting the mean and standard deviation."|At Day 180 of age|Infants born to screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID and who received a study vaccination.||Scores on a scale||Standard Deviation|Mean
846079|NCT02046148|Secondary|Infants Apgar Scores (Median, Minimum and Maximum)|Apgar (Appearance, Pulse, Grimace response, Activity and Respiration) test to evaluate the new-born's physical condition. Apgar scores between 0 and 10 (highest score possible). If 1 and 5 minutes Apgar score were normal, 10 minutes Apgar score might not be required.|At 1, 5 and 10 minutes|Infants born to screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID and who received a study vaccination.||Scores on a scale||Full Range|Median
846080|NCT02046148|Secondary|Infants Apgar Scores (Mean - Standard Deviation)|Apgar (Appearance, Pulse, Grimace response, Activity and Respiration) test to evaluate the new-born's physical condition. Apgar score between 0 and 10 (highest score possible). If 1 and 5 minutes Apgar score were normal, 10 minutes Apgar score might not be required.|At 1, 5 and 10 minutes|Infants born to screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID and who received a study vaccination.||Scores on a scale||Standard Deviation|Mean
846081|NCT02046148|Secondary|Birth Length and Head Circumference of Infants (Median - Minimum and Maximum)|Length and head circumference at birth were summarized by reporting the median and minimum and maximum|At birth|Infants born to screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID and who received a study vaccination.||Centimeter||Full Range|Median
857580|NCT00788697|Secondary|Inter-reader Agreement|Inter-reader agreement of assessment of malignant or benign by unenhanced and SonoVue-enhanced ultrasonography separately. Unit of analysis was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized. Computation for the percentage agreement within two categories: “3 out of 3 readers agree” and “2 out of 3 readers agree”.|24 hours to 6 months|||Percent of total number of lesions|||Number
857581|NCT00788697|Secondary|Specific Diagnosis of Benign FLLs|"SonoVue-enhanced versus unenhanced ultrasound for specific diagnosis of benign FLLs, using the diagnosis provided by each of the 3 off-site assessors (blinded to patient data) for the ITD population. Unit of analysis was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized.
Among the 116 ITD participants with benign lesions based on the truth standard, only 89 participants (lesions) were characterized as either hemangioma or focal nodular hyperplasia.
Truth standard: CE-CT and /or CE-MRI examination OR tissue pathology/histology from surgical resection/biopsy OR 6-month follow up. Calculated as (number of correctly characterized lesions/number of lesions per truth standard) x 100."|24 hours to 6 months|||Benign lesions|Benign lesions to be characterized||Number
846083|NCT02046148|Secondary|Birth Weight of Infants (Median, Minimum and Maximum)|Weight at birth was summarized by reporting the median and the minimum and maximum.|At Birth|Infants born to screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID and who received a study vaccination.||Kilogram||Full Range|Median
846084|NCT02046148|Secondary|Birth Weight of Infants (Mean-Standard Deviation)|Weight at birth was summarized by reporting the mean and standard deviation,|At Birth|Infants born to screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID and who received a study vaccination.||Kilogram||Standard Deviation|Mean
846085|NCT02046148|Secondary|Percentage of Infants With SAEs, Unsolicited MAEs and AEs Leading to Study Withdrawal|An SAE is defined as any untoward medical occurrence that at any dose results in one or more of the following: death; life-threatening; that does not refer to an event which hypothetically might have caused death if it were more severe; required or prolonged hospitalization; persistent or significant disability/incapacity; congenital anomaly/or birth defect; any important and significant medical event that may not be immediately life-threatening or resulting in death or hospitalization but, based upon appropriate medical judgement, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above. An MAE is defined as an adverse event that leads to an unscheduled visit to a healthcare practitioner.|From Birth through Day 180 of age|Infants born to screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID and who received a study vaccination and who provided data on unsolicited adverse events.||Percentage of Infant Subjects|||Number
846086|NCT02046148|Secondary|Percentage of Maternal Subjects With SAEs, Unsolicited MAEs and Unsolicited AEs Leading to Study Withdrawal (AEs Lead. Wthwal)|An SAE is defined as any untoward medical occurrence that at any dose results in one or more of the following: death; life-threatening; that does not refer to an event which hypothetically might have caused death if it were more severe; required or prolonged hospitalization; persistent or significant disability/incapacity; congenital anomaly/or birth defect; any important and significant medical event that may not be immediately life-threatening or resulting in death or hospitalization but, based upon appropriate medical judgement, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above. An MAE is defined as an adverse event that leads to an unscheduled visit to a healthcare practitioner.|From Study Day 32 through Day 180 postpartum|All screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID and who received a study vaccination and who provided data on unsolicited adverse events.||Percentage of Maternal Subjects|||Number
846087|NCT02046148|Secondary|Percentage of Maternal Subjects With Serious Adverse Events (SAEs), Unsolicited Medically Attended AEs (MAEs) and Unsolicited AEs Leading to Study Withdrawal (AEs Lead. Wthwal)|An SAE is defined as any untoward medical occurrence that at any dose results in one or more of the following: death; life-threatening; that does not refer to an event which hypothetically might have caused death if it were more severe; required or prolonged hospitalization; persistent or significant disability/incapacity; congenital anomaly/or birth defect; any important and significant medical event that may not be immediately life-threatening or resulting in death or hospitalization but, based upon appropriate medical judgement, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above. An MAE is defined as an adverse event that leads to an unscheduled visit to a healthcare practitioner.|From Study Day 1 through Study Day 31|All screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID and who received a study vaccination and who provided data on unsolicited adverse events.||Percentage of Maternal Subjects|||Number
846088|NCT02046148|Secondary|Percentage of Maternal Subjects With Any Unsolicited AEs|An AE is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product at any dose that does not necessarily have to have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product. This definition includes inter-current illnesses or injuries and exacerbation of pre-existing conditions.|From Study Day 1 through Study Day 31|All screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID and who received a study vaccination and who provided data on unsolicited adverse events.||Percentage of Maternal Subjects|||Number
846089|NCT02046148|Secondary|Percentage of Maternal Subjects With Solicited Local and Solicited Systemic AEs - Study Days 1-7|Percentage and frequency of maternal subjects with solicited local and solicited systemic adverse events up to Study Day 7 and calculated for four time intervals after vaccination: 30 minutes, Study Days 1-3 (without 30 min), Study Days 4-7, Study Days 1-7 (without 30 min). Threshold for Ecchymosis, Erythema, Swelling and Induration: Grade 0 (<25 mm), Any (≥ 25 mm). Systemic fever includes subjects with body temperature ≥ 38 °C irrespective of route of measurement.|During Study Days 1-7 (from 6 hours through Day 7 post-vaccination)|All screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID and who received a study vaccination and who provided data on post-vaccination local or systemic adverse events.||Percentage of Maternal Subjects|||Number
846090|NCT02046148|Secondary|Percentage of Maternal Subjects With Solicited Local and Solicited Systemic AEs - Study Days 4-7|Percentage and frequency of maternal subjects with solicited local and solicited systemic AEs up to Study Day 7 and calculated for four time intervals after vaccination: 30 minutes, Study Days 1-3 (without 30 min), Study Days 4-7, Study Days 1-7 (without 30 min). Threshold for Ecchymosis, Erythema, Swelling and Induration: Grade 0 (<25 mm), Any (≥ 25 mm). Systemic fever includes subjects with body temperature ≥ 38 °C irrespective of route of measurement.|During Study Days 4-7|All screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID and who received a study vaccination and who provided data on post-vaccination local or systemic adverse events.||Percentage of Maternal Subjects|||Number
846091|NCT02046148|Secondary|Percentage of Maternal Subjects With Solicited Local and Solicited Systemic AEs - Study Days 1-3|Percentage and frequency of maternal subjects with solicited local and solicited systemic AEs up to Study Day 7 and calculated for four time intervals after vaccination: 30 minutes, Study Days 1-3 (without 30 min), Study Days 4-7, Study Days 1-7 (without 30 min). Threshold for Ecchymosis, Erythema, Swelling and Induration: Grade 0 (<25 mm), Any (≥ 25 mm). Systemic fever includes subjects with body temperature ≥ 38 °C irrespective of route of measurement.|During Study Days 1-3 (from 6 hours through Day 3 post-vaccination)|All screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID and who received a study vaccination and who provided data on post-vaccination local or systemic adverse events.||Percentage of Maternal Subjects|||Number
846092|NCT02046148|Secondary|Percentage of Maternal Subjects With Solicited Local and Solicited Systemic Adverse Events (AEs) up to 30 Minutes|Percentage and frequency of maternal subjects with solicited local and solicited systemic AEs up to Study Day 7 and calculated for four time intervals after vaccination: 30 minutes, Study Days 1-3 (without 30 min), Study Days 4-7, Study Days 1-7 (without 30 min). Threshold for Ecchymosis, Erythema, Swelling and Induration: Grade 0 (<25 mm), Any (≥ 25 mm). Systemic fever includes subjects with body temperature ≥ 38 °C irrespective of route of measurement.|Up to 30 minutes post-vaccination|All screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID and who received a study vaccination and who provided data on post-vaccination local or systemic adverse events.||Percentage of Maternal Subjects|||Number
846093|NCT02046148|Secondary|Ratio of GBS IgG Antibody Levels – Serotype III in Infant Serum Relative to Maternal Serum at the Time of Delivery|To evaluate the relationship of serotype-specific III GBS IgG antibody levels (anti-III) in the infant serum to the GBS IgG antibody levels in the maternal serum at the time of delivery/birth. Antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The data for serotype III were not available at the time of the posting (new assay currently in development and to be validated before the results release).|At Delivery||12/2019||||
846094|NCT02046148|Secondary|Ratio of GBS IgG Antibody Levels – Serotype Ib in Infant Serum Relative to Maternal Serum at the Time of Delivery|To evaluate the relationship of serotype-specific Ib GBS IgG antibody levels (anti-Ib) in the infant serum to the GBS IgG antibody levels in the maternal serum at the time of delivery/birth. Antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The data for serotype Ib were not available at the time of the posting (new assay currently in development and to be validated before the results release).|At Delivery||12/2019||||
846095|NCT02046148|Secondary|Ratio of GBS IgG Antibody Levels – Serotype Ia in Infant Serum Relative to Maternal Serum at the Time of Delivery|To evaluate the relationship of serotype-specific Ia GBS IgG antibody levels (anti-Ia) in the infant serum to the GBS IgG antibody levels in the maternal serum at the time of delivery/birth. Antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL).|At Delivery|All screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID, who correctly received the study vaccine, who had no major protocol deviation, and who provided at least one evaluable serum sample at the relevant time points.||Ratio||95% Confidence Interval|Geometric Mean
846096|NCT02046148|Primary|Ratio Relative to Pre-vaccination Levels of Maternal Serum GBS IgG Antibody Levels – Serotype III, as Measured at Study Day 31, at Delivery and at Days 42 and 90 Postpartum|Geometric Mean Ratio relative to pre-vaccination (Day 1) of serotype-specific (III) GBS serum IgG antibody concentrations (anti-III) in maternal subjects. Antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The data for serotype III were not available at the time of the posting (new assay currently in development and to be validated before the results release).|At Day 31 (post-vaccination), Delivery, Days 42 and 90 (postpartum)||12/2019||||
846097|NCT02046148|Primary|Ratio Relative to Pre-vaccination Levels of Maternal Serum GBS IgG Antibody Levels – Serotype Ib, as Measured at Study Day 31, at Delivery and at Days 42 and 90 Postpartum|Geometric Mean Ratio relative to pre-vaccination (Day 1) of serotype-specific (Ib) GBS serum IgG antibody concentrations (anti-Ib) in maternal subjects. Antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The data for serotype Ib were not available at the time of the posting (new assay currently in development and to be validated before the results release).|At Day 31 (post-vaccination), Delivery, Days 42 and 90 (postpartum)||12/2019||||
846098|NCT02046148|Primary|Ratio Relative to Pre-vaccination Levels of Maternal Serum GBS IgG Antibody Levels – Serotype Ia, as Measured at Study Day 31, at Delivery and at Days 42 and 90 Postpartum|Geometric Mean Ratio relative to pre-vaccination (Day 1) of serotype-specific (Ia) GBS serum IgG antibody concentrations (anti-Ia) in maternal subjects. Antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL).|At Day 31 (post-vaccination), Delivery, Days 42 and 90 (postpartum)|All screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID, who correctly received the study vaccine, who had no major protocol deviation, and who provided at least one evaluable serum sample at the relevant time points.||Ratio||95% Confidence Interval|Geometric Mean
846099|NCT02046148|Primary|Concentration of Serotype III GBS IgG Levels in Maternal Serum at Pre-vaccination, at Study Day 31, at Delivery and at Days 42 and 90 Postpartum|To evaluate serotype-specific (III) GBS serum IgG antibody levels (anti-III) in maternal subjects. Antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The data for serotype III were not available at the time of the posting (new assay currently in development and to be validated before the results release).|At Day 1 (pre-vaccination), Day 31 (post-vaccination), Delivery, Days 42 and 90 (postpartum)||12/2019||||
846345|NCT01547299|Secondary|Serum Testosterone: Baseline||Baseline|All patients randomly assigned to study treatment (intent-to-treat population) with a baseline serum testosterone result.||ng/mL||Full Range|Median
846100|NCT02046148|Primary|Concentration of Serotype Ib GBS IgG Levels in Maternal Serum at Pre-vaccination, at Study Day 31, at Delivery and at Days 42 and 90 Postpartum|To evaluate serotype-specific (Ib) GBS serum IgG antibody levels (anti-Ib) in maternal subjects. Antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The data for serotype Ib were not available at the time of the posting (new assay currently in development and to be validated before the results release).|At Day 1 (pre-vaccination), Day 31 (post-vaccination), Delivery, Days 42 and 90 (postpartum)||12/2019||||
846101|NCT02046148|Primary|Concentration of Serotype Ia GBS IgG Levels in Maternal Serum at Pre-vaccination, at Study Day 31, at Delivery and at Days 42 and 90 Postpartum|To evaluate serotype-specific (Ia) GBS serum IgG antibody levels (anti-Ia) in maternal subjects. Antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL).|At Day 1 (pre-vaccination), Day 31 (post-vaccination), Delivery, Days 42 and 90 (postpartum)|All screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID, who correctly received the study vaccine, who had no major protocol deviation, and who provided at least one evaluable serum sample at the relevant time points.||µg/mL||95% Confidence Interval|Geometric Mean
846102|NCT02046148|Primary|Concentration of Serotype III GBS IgG Levels in Infant Serum at Delivery and at Days 42 and 90 of Age|To evaluate serotype-specific III GBS serum IgG antibody levels (anti-III) in infants born to maternal subjects receiving the GBS trivalent vaccine, as measured at birth, Day 42 and Day 90 of age. Antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The data for seortype III were not available at the time of the posting (new assay currently in development and to be validated before the results release).|At Birth, Day 42 and Day 90||12/2019||||
846103|NCT02046148|Primary|Concentration of Serotype Ib GBS IgG Levels in Infant Serum at Delivery and at Days 42 and 90 of Age|To evaluate serotype-specific Ib GBS serum IgG antibody levels (anti-Ib) in infants born to maternal subjects receiving the GBS trivalent vaccine, as measured at birth, Day 42 and Day 90 of age. Antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The data for serotype Ib were not available at the time of the posting (new assay currently in development and to be validated before the results release).|At Birth, Day 42 and Day 90||12/2019||||
846104|NCT02046148|Primary|Concentration of Serotype Ia GBS IgG Levels in Infant Serum at Delivery and at Days 42 and 90 of Age|To evaluate serotype-specific Ia GBS serum IgG antibody levels (anti-Ia) in infants born to maternal subjects receiving the GBS trivalent vaccine, as measured at birth, Day 42 and Day 90 of age. Antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL).|At Birth, Day 42 and Day 90|All screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID, who correctly received the study vaccine, who had no major protocol deviation, and who provided at least one evaluable serum sample at the relevant time points.||µg/mL||95% Confidence Interval|Geometric Mean
846117|NCT01994629|Secondary|Number of Subjects Reporting Unsolicited (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine.|Safety was assessed in terms of number of subjects (12 to 15 months old) reporting unsolicited AEs (day 1 to day 29), SAEs, medically attended AEs, AEs leading to premature study withdrawal (Day 1 to Day 180) after vaccination with one dose of either MenACWY-CRM or comparator MenACWY-TT vaccine.|Day 1 to Day 29 or Day 1 to Day 180 post-vaccination|Analysis was done on unsolicited safety data set ie, all subjects in the exposed set who had post-vaccination unsolicited adverse event records.||Subjects|||Number
846118|NCT01994629|Secondary|Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine.|Safety was assessed in terms of number of subjects (12 to 15 months old) reporting any and each of solicited local and systemic AEs reported from Day 1 to 7 after vaccination with one dose of either MenACWY-CRM or comparator MenACWY-TT vaccine.|Day 1 (6 hours) to Day 7 post-vaccination|Analysis was done on solicited safety data set. MedDRA version v.3.0 was used for the analyses (in the AEs section, MedDRA version v.17.01 was used, leading to a different terminology to describe some of the events reported in this outcome).||Subjects|||Number
846119|NCT01994629|Secondary|rSBA GMT Against N. Meningitidis Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine.|Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by rSBA GMTs directed against N. meningitidis serogroups A, C, W, and Y on Day 29 after vaccination. Persistence of immune responses was measured by rSBA GMTs on Day 180.|Day 1, Day 29 and Day 180 post-vaccination|Analysis at Day 29 was done on FAS set at Visit Day 29. Persistence of immune responses at Day 180 was analysed on FAS at Visit Day 180.||Titers||95% Confidence Interval|Geometric Mean
846822|NCT01106534|Secondary|ST for Treatment Population||12 through 30 months and 12 through 33 months|Participants enrolled in the study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.|||||
846120|NCT01994629|Secondary|Percentages of Subjects With Four-fold Increase in rSBA Titers Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine.|Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by the percentages of subjects with four-fold increase in rSBA titer directed against N. meningitides serogroups A, C, W, and Y on Day 29 after vaccination. Persistence of immune response was measured by the percentages of subjects with four-fold increase in rSBA titer on Day 180 after vaccination.|Day 29 and Day 180 post-vaccination|Analysis at Day 29 was done on FAS set at Visit Day 29. Persistence of immune responses at Day 180 was analysed on FAS at Visit Day 180.||percentage of Subjects||95% Confidence Interval|Number
846121|NCT01994629|Secondary|Percentages of Subjects With rSBA Titer ≥ 128 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine.|Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by the percentages of subjects with rSBA titer ≥ 128 directed against N. meningitidis serogroups A, C, W, and Y on Day 29 after vaccination. Persistence of immune response was measured by percentages of subjects with rSBA titer ≥ 128 on Day 180 after vaccination.|Day 1, Day 29 and Day 180 post-vaccination|Analysis at Day 29 was done on FAS set at Visit Day 29. Persistence of immune responses at Day 180 was analysed on FAS at Visit Day 180.||percentage of Subjects||95% Confidence Interval|Number
846122|NCT01994629|Secondary|Percentages of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titer ≥ 8 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine.|Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by the percentages of subjects with rSBA titer ≥ 8 directed against N. meningitidis serogroups A, C, W, and Y on Day 29 after vaccination. Persistence of immune response was measured by percentages of subjects with rSBA titer ≥ 8 on Day 180 after vaccination.|Day 1, Day 29 and Day 180 post-vaccination|Analysis at Day 29 was done on FAS set at Visit Day 29. Persistence of immune responses at Day 180 was analysed on FAS at Visit Day 180.||percentage of Subjects||95% Confidence Interval|Number
846123|NCT01994629|Secondary|hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine.|Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by hSBA GMTs directed against N. meningitidis serogroups A, C, W, and Y on Day 29 after vaccination. Persistence of immune response was measured by hSBA GMTs at Day 180 after vaccination.|Day 1, Day 29 and Day 180 post-vaccination|Analysis at Day 29 was done on FAS set at Visit Day 29. Persistence of immune responses at Day 180 was analysed on FAS at Visit Day 180.||Titers||95% Confidence Interval|Geometric Mean
846124|NCT01994629|Secondary|Percentages of Subjects With Seroresponse Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine.|Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by the percentages of subjects with seroresponse defined as for subjects with pre-vaccination hSBA titer < 4, post-vaccination hSBA titer ≥ 8; for subjects with pre-vaccination hSBA titer ≥ 4, an increase of at least four times the pre-vaccination hSBA directed against N. meningitidis serogroups A, C, W, and Y on Day 29 after vaccination. Persistence immune response was measured by the percentage of subjects with seroresponse at Day 180 after vaccination.|Day 29 and Day 180 post-vaccination|Analysis at Day 29 was done on FAS set at Visit Day 29. Persistence of immune responses at Day 180 was analysed on FAS at Visit Day 180.||percentage of Subjects||95% Confidence Interval|Number
846125|NCT01994629|Secondary|Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 8 Against (N. Meningitidis) Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine.|Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by the percentages of subjects with hSBA titer ≥ 8 directed against Neisseria meningitidis (N. meningitidis) serogroups A, C, W, and Y on Day 29 after vaccination. Persistence of immune responses was measured by the percentages of subjects with hSBA titer ≥ 8 on Day 180 post-vaccination.|Day 1, Day 29 and Day 180 post-vaccination|Analysis was done on Full Analysis Set (FAS) Day 29 (subjects who received the vaccine and provided immunogenicity data at Day 29: MenACWY-CRM 95; MenACWT-TT 97). Persistence of immune responses at Day 180 was analysed on FAS Day 180 (subjects who received the vaccine and provided immunogenicity data at Day 180: MenACWY-CRM 98; MenACWT-TT 97).||percentage of Subjects||95% Confidence Interval|Number
846126|NCT01994629|Primary|Number of Subjects With at Least One Severe Solicited Adverse Event (AE) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT.|Reactogenicity of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by number of subjects with at least one severe solicited AE within 7 days after vaccination. Solicited AEs included tenderness, erythema, induration, irritability, sleepiness, change in eating habits, vomiting, diarrhea and fever.|Day 1 to Day 7 post-vaccination|Analysis was done on the solicited safety data set (all subjects in the exposed set who provided post vaccination reactogenicity data: MenACWY-CRM 99; MenACWY-TT 101).||Number of Subjects|||Number
846127|NCT01954251|Secondary|Number of Subjects With Potential Immune-mediated Diseases (pIMDs)|pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|From first vaccination up to Month 18 (study end)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.||Subjects|||Number
846128|NCT01954251|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From first vaccination up to Month 18 (study end)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.||Subjects|||Number
846150|NCT01903720|Secondary|Change From Baseline in CRT at Each Visit|CRT was measured in the study eye using optical computed tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina. A negative change from Baseline indicates an improvement.|Baseline, Week 1, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12|"ITT population included all enrolled participants. n in the category is the number of participants with data available at the given time-point for analysis."||micrometers (μm)||Standard Deviation|Mean
846129|NCT01954251|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During 30 days (Days 0-29) after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.||Subjects|||Number
846130|NCT01954251|Secondary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|Within 7 days (Days 0-6) across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered, on subjects with their symptom sheets completed.||Subjects|||Number
846131|NCT01954251|Secondary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|Within 7 days (Days 0-6) after each vaccine dose|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered, on subjects with their symptom sheets completed.||Subjects|||Number
846132|NCT01954251|Secondary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|Within 7 days (Days 0-6) after each vaccine dose|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered, on subjects with their symptom sheets completed.||Subjects|||Number
846133|NCT01954251|Secondary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Relationship analysis was not performed.|Within 7 days (Days 0-6) across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered, on subjects with their symptom sheets completed.||Subjects|||Number
846134|NCT01954251|Secondary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 (G3) pain = pain that prevented normal activity. Grade 3 (G3) redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Relationship analysis was not performed.|Within 7 days (Days 0-6) after each vaccine dose|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered, on subjects with their symptom sheets completed.||Subjects|||Number
846135|NCT01954251|Secondary|Geometric Mean Ratio for Flu HI Antibodies Post-vaccination Titer|The geometric mean ratio for Flu HI antibodies against the four influenza vaccine strains Flu A/California/7/2009, Flu A/Texas/50/2012, Flu B/Brisbane/60/2008 Victoria and Flu B/Massachusetts/2/2012 Yamagata was defined as the geometric mean of the within subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer.|At Day 21 post vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measures were available.||Ratio||95% Confidence Interval|Geometric Mean
846136|NCT01954251|Secondary|Number of Seroconverted Subjects in Terms of HI Antibodies|The number of seroconverted subjects was assessed in terms of HI antibodies against the four influenza vaccine strains Flu A/California/7/2009, Flu A/Texas/50/2012, Flu B/Brisbane/60/2008 Victoria and Flu B/Massachusetts/2/2012 Yamagata.|At Day 21 post vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measures were available.||Subjects|||Number
846137|NCT01954251|Secondary|FLU Haemagglutination Inhibition (HI) Antibody Titers|HI antibody titres against the four influenza vaccine strains Flu A/California/7/2009, Flu A/Texas/50/2012, Flu B/Brisbane/60/2008 Victoria (Vic) and Flu B/Massachusetts (Massach)/2/2012 Yamagata (Yamma) were expressed as geometric mean titers (GMTs).|At Day 0 (PRE) and Day 21 post vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measures were available.||Titers||95% Confidence Interval|Geometric Mean
846138|NCT01954251|Secondary|Number of Seroprotected Subjects With HI Antibody Titers ≥ 1:40|Seroprotection rate is defined as the percentage of vaccines with a serum HI titer ≥1:40 that usually was accepted as indicating protection. FLU HI antibodies were assessed in four strains: Flu A/California/7/2009 H1N1, Flu A/Texas/50/2012 H3N2, Flu B/Brisbane/60/2008 Victoria (Vic) and Flu B/Massachusetts(Massach)/2/2012 Yamagata (Yama).|At Day 0 (PRE) and at Day 21 post vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measures were available.||Subjects|||Number
846139|NCT01954251|Secondary|Number of Subjects With FLU HI Antibody Titers ≥1:10|FLU HI antibodies were assessed in four strains: Flu A/California/7/2009 H1N1, Flu A/Texas/50/2012 H3N2, Flu B/Brisbane/60/2008 Victoria and Flu B/Massachusetts (Massach)/2/2012 Yamagata (Yama). Cut-off titer for seropositivity was 1:10.|At Day 0 (PRE) and 21 post vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measures were available.||Subjects|||Number
846140|NCT01954251|Primary|FLU Haemagglutination Inhibition (HI) Antibody Titers|"For each strain included in the FLU-D-QIV vaccine, an ANOVA model was used to analyze post-vaccination log-transformed titers. The fixed-effect model included the minimization variable (age cohorts) and the treatment as fixed effect. The pre-vaccination log-transformed concentrations were included as continuous covariate. Geometric Means (GM) of post-vaccination titers (Day 21) were calculated conditionally to the means of the pre-vaccination log-transformed titers (Month 0) for each strain.
Adjusted GMTs (GMTs adjusted for baseline titers) and Adjusted GMT ratios were calculated together with 2-sided 95% CIs."|At Day 21 post vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measures were available.||Titers||95% Confidence Interval|Geometric Mean
846141|NCT01954251|Primary|Adjusted Geometric Mean ELISA Concentrations of Anti-gE Antibodies|Geometric means (GMs) of post-vaccination concentrations (Month 3 for GSK1437173A + GSK2321138A group and Month 5 for Control group) was calculated conditionally to the means of the pre-vaccination log-transformed concentrations for anti-gE (Month 0 for GSK1437173A + GSK2321138A group and Month 2 for Control group). Adjusted Least Squares (LS) means and difference of LS means between the groups were calculated together with 2-sided 95% CIs and back-transformed to the original units to provide GMCs.|At one month post-dose 2 (Month 3 for GSK1437173A + GSK2321138A group and Month 5 for Control group)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measures were available.||mIU/mL||95% Confidence Interval|Geometric Mean
846142|NCT01954251|Primary|Vaccine Response for Anti-gE Humoral Immunogenicity|"The vaccine response(VRR) for anti-gE humoral immunogenicity, as determined by enzyme-linked immunosorbent assay (ELISA),was assessed only in subjects from the GSK1437173A + GSK2321138A Group. The VRR for anti-gE was defined as the percentage of subjects who had at least:
a 4-fold increase in the post-dose 2 anti-gE antibody concentration as compared to the pre-vaccination anti-gE antibody concentration, for subjects who were seropositive at baseline (cut-off ≥ 97 mIU/ml), or, a 4-fold increase in the post dose 2 anti-gE antibody concentrations as compared to the anti-gE antibodies cut-off value for seropositivity, for subjects who were seronegative at baseline (cut-off < 97 mIU/ml).Criterion used: the objective was met if the Lower Limit (LL) of the 95% confidence interval (CI) of the VRR for anti-gE antibody concentrations was at least 60%."|At one month post-dose 2 (Month 3)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measures were available.||Percentage||95% Confidence Interval|Number
846143|NCT01954251|Primary|Number of Subjects With Vaccine Response to Anti-gE Antibodies|The vaccine response(VRR) for anti-gE humoral immunogenicity, as determined by enzyme-linked immunosorbent assay (ELISA),was assessed only in subjects from the GSK1437173A + GSK2321138A Group. The VRR for anti-gE was defined as the percentage of subjects who had at least: a 4-fold increase in the post-dose 2 anti-gE antibody concentration as compared to the pre-vaccination anti-gE antibody concentration, for subjects who were seropositive at baseline (cut-off ≥ 97 mIU/ml), or, a 4-fold increase in the post dose 2 anti-gE antibody concentrations as compared to the anti-gE antibodies cut-off value for seropositivity, for subjects who were seronegative at baseline (cut-off < 97 mIU/ml).|At one month post-dose 2 (Month 3)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measures were available.||Subjects|||Number
846144|NCT01903720|Secondary|Percentage of Participants Who Received Laser Treatments|Participants underwent laser photocoagulation therapy for all areas of foveal leakage and non-perfusion, as well as areas of extensive retinal hyperplasia if applicable for rescue therapy.|12 Months|ITT population included all enrolled participants.||percentage of participants|||Number
846145|NCT01903720|Secondary|Time to Third Injection|Time in weeks from the second injection to the third injection.|12 Months|ITT population included all enrolled participants.||weeks||Standard Deviation|Mean
846146|NCT01903720|Secondary|Time to Second Injection|Time in weeks from the first injection to the second injection.|12 Months|ITT population included all enrolled participants.||weeks||Standard Deviation|Mean
846147|NCT01903720|Secondary|Percentage of Participants Receiving a Third Injection||12 Months|ITT population included all enrolled participants.||percentage of participants|||Number
846148|NCT01903720|Secondary|Percentage of Participants Receiving a Second Injection||12 Months|ITT population included all enrolled participants.||percentage of participants|||Number
846149|NCT01903720|Secondary|Percentage of Participants With a Change From Baseline of 15 or More Letters in BCVA|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly ranging from 0 (worst) to 100 letters (best). An increase in the number of letters read correctly means that the vision improved and a decrease in the number of letters read correctly means that the vision has worsened.|Baseline, Months 6 and 12|"ITT population included all enrolled participants. n in the category is the number of participants with data available at the given time-point for analysis."||percentage of participants|||Number
846151|NCT01903720|Secondary|Change From Baseline in BCVA at Each Visit|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly ranging from 0 (worst) to 100 letters (best). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened.|Baseline, Week 1, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12|"ITT population included all enrolled participants. n in the category is the number of participants with data available at the given time-point for analysis."||letters||Standard Deviation|Mean
846152|NCT01903720|Secondary|Change From Baseline in CRT at Month 12|CRT was measured in the study eye using optical computed tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina. A negative change from Baseline indicates an improvement.|Baseline, Month 12|"ITT population included all enrolled participants. n in the category is the number of participants with data available for analysis."||μm||Standard Deviation|Mean
846153|NCT01903720|Secondary|Change From Baseline in BCVA at Month 12|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly ranging from 0 (worst) to 100 letters (best). A positive number change in the number of letters read correctly means that the vision improved and a negative number change in the number of letters read correctly means that the vision has worsened.|Baseline, Month 12|"ITT population included all enrolled participants. n in the category is the number of participants with data available for analysis."||letters||Standard Deviation|Mean
846154|NCT01903720|Secondary|Change From Baseline in Central Retinal Thickness (CRT) at Month 6|CRT was measured in the study eye using optical computed tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina. A negative change from Baseline indicates an improvement.|Baseline, Month 6|"ITT population included all enrolled participants. n in the category is the number of participants with data available for analysis."||micrometers (μm)||Standard Deviation|Mean
846155|NCT01903720|Primary|Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 6|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly ranging from 0 (worst) to 100 letters (best). A positive number change in the number of letters read correctly means that the vision improved and a negative number change in the number of letters read correctly means that the vision has worsened.|Baseline, Month 6|"Intent-to-treat (ITT) population included all enrolled participants. n in the category is the number of participants with data available for analysis."||letters||Standard Deviation|Mean
846156|NCT01867307|Primary|Change From Baseline of Renal Tubular Maximum Reabsorptive Capacity for Glucose (TmG) at End of Empagliflozin Treatment (Day 14)|"Change from baseline of renal tubular maximum reabsorptive capacity for glucose (TmG) at end of empagliflozin treatment (Day 14).
Per-protocol set (PPS): PPS consisted of all subjects and patients in the TS who completed the treatment day 14 clamping study without any relevant deviations either in their treatment regimen or in the performance and timing of the measurements."|Baseline and Day 14|Analysable set (AS): This data set is based on the PPS and excluded all primary endpoint and exploratory endpoint data for one healthy subject due to outlying values that were identified in the subject’s TmG and urine splay data.||(milligram / minute/ 1.73 square meters)||Standard Deviation|Mean
846157|NCT01867047|Post-Hoc|Length of Stay|Length of stay in days|Discharge from hospital (approximately 5 days)|||Days||Full Range|Median
846158|NCT01867047|Secondary|Number of Participants With Acute Kidney Injury|Number of participants with acute kidney injury will be recorded.|Discharge from hospital (approximately 5 days)|||Participants|||Count of Participants
846159|NCT01867047|Secondary|Number of Participants That Received Allogeneic Blood|The number of participants that received allogeneic blood will be recorded.|Discharge from hospital (approximately 5 days)|||Participants|||Count of Participants
846160|NCT01867047|Secondary|Number of Participants Transferred to Intensive Care Unit (ICU)|The number of participants transferred to Intensive Care Unit (ICU) will be recorded|Discharge from hospital (approximately 5 days)|||Participants|||Count of Participants
846161|NCT01867047|Primary|Number of Participants Given Vasopressors|The number of participants who received vasopressors.|Discharge from hospital (approximately 5 days)|||Participants|||Count of Participants
846162|NCT01867047|Primary|Number of Participants With Severe Hypotension|The number of participants with severe hypotension (Systolic Blood Pressure less than 65 mmHG) will be recorded.|From baseline to discharge from hospital (approximately 5 days)|||Participants|||Count of Participants
846163|NCT01867047|Primary|Number of Participants With Mild Hypotension|The number of participants with mild hypotension (Systolic Blood Pressure (SBP) less than 85 mmHG) will be recorded.|From baseline to discharge from hospital (approximately 5 days)|||Participants|||Count of Participants
846164|NCT01816048|Primary|Change in Total NaF PET/CT Standardized Uptake Values|To measure changes in NaF PET/CT standardized uptake values (SUV total) from prior to dosing with Tak-700 to12 weeks after starting treatment with TAK-700|up to 3 months|The study closed early so only 8 of 20 planned were enrolled and of the 8, only 4 completed the week 12 scan so there was not sufficient data to make an analysis.||Participants|||Count of Participants
846165|NCT01816048|Secondary|To Compare PSA Response Rate and Circulating Tumor Cell Counts of Subjects Receiving TAK700 to NaF PET/CT Imaging Results||Baseline, one month, 2 months, 3 months|Due to study closing early only 8 of planned 20 patients enrolled and only 4 of the subjects completed the week 12 scan and 5 of the 8 subjects came off study early. Data for PSA response rate and circulating tumor cell counts was not collected, and as a result there is no data to report or analyze for this endpoint.|||||
846166|NCT01816048|Secondary|To Document Change in the Number of Circulating Tumor Cells Using the Cell Search System (Veridex, LLC) Obtained Prior to Beginning Treatment With TAK 700, After Completing One Cycle and After Completing 3 Cycles.||Up to 14 months|Due to study closing early only 8 of planned 20 patients enrolled and only 4 of the subjects completed the week 12 scan and 5 of the 8 subjects came off study early. As a result there is not sufficient data to analyze this endpoint.||Participants|||Count of Participants
846167|NCT01816048|Secondary|To Document the Change in the Number of Circulating Tumor Cells Using One or More Methods (Epispot)|Baseline compared to 12 weeks|Up to 12 weeks|Due to study closing early only 8 of planned 20 patients enrolled and only 5 of the subjects obtained week 12 CTC test. Data was collected, but there is not sufficient data to analyze this endpoint.||Participants|||Count of Participants
848365|NCT00073073|Secondary|Absolute Change of Lipid Profiles on Exemestane From Baseline||1 year|Change in total cholesterol||mg/dl||Standard Deviation|Mean
846168|NCT01816048|Secondary|Compare Changes on NaF PET/CT After Treatment With TAK700 With Standard Clinical Outcomes Including PSA Doubling Time, Response Evaluation Criteria in Solid Tumors (RECIST), and Radiographic Progression Free Survival.||Approximately 24 months|Due to study closing early only 8 of planned 20 patients enrolled and only 4 of the subjects completed the week 12 scan and 5 of the 8 subjects came off study early. Data for this endpoint was not collected. Radiographic progression free survival was not obtained.|||||
846169|NCT01816048|Secondary|Changes in NaF PET/CT Results in Response to TAK700|This is an exploratory endpoint as we are planning to identify other new parameters during the PET/CT scanning that may be more predictive of response (such as SUV volume, or dynamic changes during the scanning period). Changes in results at week 12 compared to baseline.|Up to 12 weeks|Due to study closing early only 8 of planned 20 patients enrolled and only 7 of the 8 subjects enrolled complete the week 6 scan so there is not sufficient data to analyze.||Participants|||Count of Participants
846170|NCT01816048|Secondary|Measure Change in PSA Kinetics With TAK700 From Baseline to Off Treatment|Stable: no change in PSA kinetics Decrease: less than baseline Increase: greater than baseline|Up to 14 months|Due to study closing early only 8 of planned 20 patients enrolled and 5 of the 8 subjects came off study early so PSA data is not complete and can't be analyzed.||Participants|||Count of Participants
846171|NCT01816048|Secondary|Number of Subjects Who Experience Adverse Events While on Treatment With TAK 700|The number of subjects experiencing adverse events per CTCAE 4.0 while on treatment.|Up to 12 months|||participants|||Number
846172|NCT01816048|Primary|Prostate Specific Antigen (PSA) Response Rate|Measure prostate specific antigen (PSA) response rate in patients treated with TAK700, as measured by a decline in the PSA level from baseline to the month 3 assessment according to the Prostate Cancer Clinical Trials Working Group (PCWG2), at least a 50% decrease from baseline.|Up to 3 months|Study closed early and only 8 of planned 20 enrolled. Five of the 8 subjects did not complete the study as planned. As a result, there was not sufficient data to make any analysis.||Participants|||Count of Participants
846173|NCT01816048|Primary|Change in Maximum NaF PET/CT Standardized Uptake Values|To measure changes in NaF PET/CT standardized uptake values (SUVmax) from prior to dosing with Tak-700 to12 weeks after starting treatment with TAK-700|up to 3 months|The study closed early so only 8 of 20 planned were enrolled and of the 8, only 4 completed the week 12 scan so there was not sufficient data to make an analysis.||Participants|||Count of Participants
846177|NCT01804842|Primary|Rmax (0-24) of Plasma Glucose|Rmax (0-24) = maximum response from the start time of the standardized dinner (0 h) to 24 hours after the standardized dinner. Study medication was administered at t = 0 hours for Treatments B and C and at t = 12 hours for Treatments A and C.|Times points to determine Rmax were: t = -0.08, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 11.75, 11.92, 12.5, 13, 13.5, 14, 14.5, 15, 16, 17, 18, 18.5, 19, 19.5, 20, 21, 22, 23, and 24 hours relative to the start time of the standardized dinner.|Evaluable Population||mg/dL||Standard Error|Least Squares Mean
846178|NCT01804842|Primary|AUC (0-24) of Plasma Glucose|AUC (0-24) = Area under the curve from the start time of the standardized dinner (0 h) to 24 hours after the standardized dinner. Study medication was administered at t = 0 hours for Treatments B and C and at t = 12 hours for Treatments A and C.|Times points to create the AUC (0-24) were: t = -0.08, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 11.75, 11.92, 12.5, 13, 13.5, 14, 14.5, 15, 16, 17, 18, 18.5, 19, 19.5, 20, 21, 22, 23, and 24 hours relative to the time of the standardized dinner.|Evaluable Population||mg*h/dL||Standard Error|Least Squares Mean
846179|NCT01804842|Primary|Cmax of Plasma Metformin|Cmax = maximum response from the start time of the standardized dinner (0 h) to 24 hours after the standardized dinner. Study medication was administered at t = 0 hours for Treatments B and C and at t = 12 hours for Treatments A and C.|Times points to determine Cmax were: t = -0.08, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 11.92, 12.5, 13, 13.5, 14, 14.5, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 hours relative to the start time of the standardized dinner.|Evaluable Population||ng/mL||Standard Error|Least Squares Mean
846180|NCT01804842|Primary|AUC (0-24) of Plasma Metformin|AUC (0-24) = Area under the curve from the start time of the standardized dinner (0 h) to 24 hours after the standardized dinner. Study medication was administered at t = 0 hours for Treatments B and C and at t = 12 hours for Treatments A and C.|Times points to create the AUC (0-24) were: t = -0.08, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 11.92, 12.5, 13, 13.5, 14, 14.5, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 hours relative to the start time of the standardized dinner.|Evaluable Population||ng*h/mL||Standard Error|Least Squares Mean
846181|NCT01797094|Secondary|Percentage of Participants Mostly or Very Satisfied With Their Crow’s Feet Lines on the Facial Line Satisfaction Questionnaire|Participants assessed their overall satisfaction at the present moment using a 5-point scale where -2=very dissatisfied, -1=mostly dissatisfied, 0=neither dissatisfied nor satisfied, 1=mostly satisfied and 2=very satisfied. The percentage of participants mostly or very satisfied is reported.|Day 30|Intent-to-treat population included all enrolled participants.||percentage of participants|||Number
847232|NCT00734539|Secondary|Candidiasis|Definite or probable|prior to hospital discharge, up to 15 ½ months|Modified intent-to-treat; only subjects who received at least one dose of study drug.||participants|||Number
846182|NCT01797094|Secondary|Percentage of Participants Who Rate Themselves in a Younger Self-Perception of Age Category Than at Baseline|"Participants were considered to judge themselves as looking younger if the category change was from look my current age at Baseline to look younger at Day 30 or from look older at Baseline to look my current age/younger at Day 30."|Baseline, Day 30|Intent-to-treat population included all enrolled participants. Only those participants who rated themselves as looking their current age or older at Baseline were included in the analyses.||percentage of participants|||Number
846183|NCT01797094|Secondary|Percentage of Participants With a ≥3-Point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 8 at Day 30|The FLO-11 questionnaire is comprised of 11 items that assess the subject's perceptions about specific aspects of their facial lines for the previous 7 days. Each question was scored on an 11-point scale (0=not at all, 5=somewhat, 10=very much) FLO-11 responders were defined as the percentage of participants with a ≥3-point improvement from Baseline in FLO-11 Item 8: “My facial lines make me look tired” score.|Baseline, Day 30|Intent-to-treat population included all enrolled participants. Only participants with FLO-11 Item 8 scores ≥ 3 at Baseline were included in the analysis.||percentage of participants|||Number
846184|NCT01797094|Secondary|Percentage of Participants With a ≥2-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 5 at Day 30|The FLO-11 questionnaire is comprised of 11 items that assess the subject's perceptions about specific aspects of their facial lines for the previous 7 days. Each question was scored using an 11-point scale (0=not at all, 5=somewhat, 10=very much). FLO-11 responders were defined as the percentage of participants with a ≥2-point improvement from Baseline in FLO-11 Score Item 5: “My facial lines make me look less attractive than I want to look” score.|Baseline, Day 30|Intent-to-treat population included all enrolled participants. Only participants with FLO-11 Item 5 scores ≥2 at Baseline are included in the analysis.||percentage of participants|||Number
846185|NCT01797094|Secondary|Percentage of Participants With a ≥2-Point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 2 at Day 30|The FLO-11 questionnaire is comprised of 11 items that assess the subject's perceptions about specific aspects of their facial lines for the previous 7 days. Each question was scored on an 11-point scale (0=not at all, 5=somewhat, 10=very much). FLO-11 responders were defined as the percentage of participants with a ≥2-point improvement from Baseline in FLO-11 Item 2 : “When I look in the mirror, my facial lines make me look older than I want to look” score.|Baseline, Day 30|Intent-to-treat population included all enrolled participants. Only participants with FLO-11 Item 2 scores ≥2 at Baseline are included in the analysis.||percentage of participants|||Number
846186|NCT01797094|Secondary|Percentage of Participants Much Improved or Very Much Improved in the Subject's Assessment of Appearance of CFL as Measured by the Global Assessment of Change in Crow’s Feet Lines (SGA-CFL)|Participants rated the change in their Crow's Feet Lines using the SGA-CFL 7-point scale where 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse or 7=very much worse at Day 30. The percentage of participants who reported Much Improved or Very Much Improved at Day 30 is reported.|Day 30|Intent-to-treat population included all enrolled participants.||percentage of participants|||Number
846187|NCT01797094|Primary|Percentage of Participants Achieving None or Mild on the Investigator's Assessment of the Severity of Crow's Feet Lines (CFL) at Maximum Smile Using the Facial Wrinkle Scale-Asian (FWS-A)|The Investigator assessed the severity of the participant's Crow's Feet lines at maximum smile using the 4-point Facial Wrinkle Scale where 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30 is reported.|Day 30|Intent-to-treat population included all enrolled participants.||percentage of participants|||Number
846188|NCT01797081|Secondary|Percentage of Participants Who Rate Themselves in a Younger Self-Perception of Age Category Than at Baseline|"Participants were considered to judge themselves as looking younger if the category change was from look my current age at Baseline to look younger at Day 30 or from look older at Baseline to look my current age/younger at Day 30."|Day 30|Intent-to-treat population included all enrolled participants. Only those participants who rated themselves as looking their current age or older at Baseline were included in the analyses.||percentage of participants|||Number
846189|NCT01797081|Secondary|Percentage of Participants Much Improved or Very Much Improved in the Subject's Assessment of Appearance of CFL as Measured by the Global Assessment of Change in Crow’s Feet Lines|Participants rated the change in their Crow's Feet Lines using the Subject’s Global Assessment of Change in Crow’s Feet Lines (SGA-CFL) 7-point scale where 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse or 7=very much worse. The percentage of participants who reported Much Improved or Very Much Improved at Day 30 is reported.|Day 30|Intent-to-treat population included all enrolled participants.||percentage of participants|||Number
846190|NCT01797081|Secondary|Percentage of Participants Achieving a ≥1-Grade Improvement From Baseline on the Investigator's Assessment of the Severity of CFL at Rest Using the FWS-A|The Investigator assessed the severity of the participant's Crow's Feet Lines at rest using the 4-point Facial Wrinkle Scale where 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a ≥1-grade improvement from Baseline at Day 30 is reported.|Day 30|Participants from the Intent-to-treat population, all enrolled participants, with data available for analysis.||percentage of participants|||Number
846191|NCT01797081|Primary|Percentage of Participants Achieving None or Mild on the Investigator's Assessment of the Severity of Crow's Feet Lines (CFL) at Maximum Smile Using the Facial Wrinkle Scale-Asian (FWS-A)|The Investigator assessed the severity of the patient's Crow's Feet lines at maximum smile using the 4-point Facial Wrinkle Scale where 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30 is reported.|Day 30|Intent-to-treat population included all enrolled participants.||percentage of participants|||Number
846216|NCT01710046|Secondary|Psoriasis Area and Severity Index (PASI) Score by Visit|Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0=0% to 6=90â€“100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4) summed over all sections; total possible score range: 0= no disease to 72= maximal disease.|Baseline and Weeks 1, 2, 4, and 12|FAS; n (number) =number of participants with nonmissing observations at the specified visit.||units on a scale||Standard Error|Mean
846192|NCT01721746|Secondary|Mean Change From Baseline in Health-related Quality of Life (HRQoL) Global Health Status Scores|Health-related Quality of Life (HRQoL) was assessed with the EORTC QLQ-C30 questionnaire, which is the most commonly used quality-of-life instrument in oncology trials. The instrument’s 30 items were divided among 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, pain, nausea/vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties), and a global health/quality of life scale. Raw scores for the EORTC QLQ-C30 were transformed to a 0-100 metric. Higher scores for all functional scales and Global Health Status=better HRQoL; an increase from baseline indicates improvement in HRQoL. Lower scores for symptom scales=better HRQoL; a decline from baseline for symptom scales =improvement in symptoms compared to baseline. A 10 point difference on a 100 point scale between treatments was considered clinically significant.|From Baseline (Day1) to second Follow-Up; up to 37 months|All randomized participants with a baseline measurement and at least one on-study assessment; n=number of participants evaluable||units on a scale||Standard Deviation|Mean
846193|NCT01721746|Secondary|Median Overall Survival (OS) Time in Months by Baseline PD-L1 Expression|"PD-L1 expression evaluated as a predictive biomarker for OS by analyzing the interaction between PD-L1 expression and treatment arms. Randomized participants with an Indeterminate PD-L1 result per the verified assay were categorized as Subjects without Tumor Tissue Samples. Overall Survival (OS) was defined the time between the date of randomization to the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive. OS was followed continuously while participants were on the study drug and every 3 months via in-person or phone contact after participants discontinued the study drug. The interim OS analysis was performed on all randomized subjects when at least 169 events had been observed. Analysis made at Primary Endpoint; Study On-going."|From the date of randomization to the date of death; up to 37 months|All PD-L1 Evaluable Participants; Randomized participants among the OS population who had a tumor biopsy specimen assessed for PD-L1 expression with the validated assay and for which quantifiable tumor PD-L1 levels were discernible.||months||95% Confidence Interval|Median
846194|NCT01721746|Secondary|Objective Response Rate (ORR) by Baseline PD-L1 Expression|PD-L1 expression evaluated as a predictive biomarker for ORR by analyzing the interaction between PD-L1 expression and treatment arms. Randomized participants with an Indeterminate PD-L1 result per the verified assay were categorized as “Subjects without Tumor Tissue Samples”. ORR=number of participants with a Best Overall Response (BOR) of complete response (CR) or partial response (PR) divided by number of randomized participants and reported as a percentage. Analysis made at Primary Endpoint; Study On-going.|From date of randomization to the date of objectively documented progression or the date of subsequent therapy; approx. 16 months|All PD-L1 Evaluable Participants; Randomized participants among the ORR population who had a tumor biopsy specimen assessed for PD-L1 expression with the validated assay and for which quantifiable tumor PD-L1 levels were discernible.||percentage of participants||95% Confidence Interval|Number
846195|NCT01721746|Secondary|Median Months of Progression-free Survival (PFS) Per Independent Radiology Review Committee (IRC/IRRC)|PFS=time from randomization to the date of the first documented progression or death due to any cause, whichever first. Participants who (1) died without a reported progression were considered to have progressed on the date of their death, (2) did not progress or die were censored on the date of their last evaluable tumor assessment, (3) did not have any on study tumor assessments and did not die were censored on the date they were randomized, and (4) started any subsequent anti-cancer therapy (including tumor-directed radiotherapy or surgery) without a prior reported progression were censored at the last evaluable tumor assessment prior to or upon initiation of the subsequent anti-cancer therapy. Per RECIST 1.1, progression is >= 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (includes baseline sum if smallest on study). The sum must demonstrate an absolute increase of >= 5 mm. Analysis made at Primary Endpoint; Study On-going|From the date of randomization to the date of the first documented progression or death; up to 37 months|All Randomized Participants: All participants randomized to any treatment group||months||95% Confidence Interval|Number
846196|NCT01721746|Primary|Median Overall Survival (OS) at Primary Endpoint|Overall Survival (OS) was defined the time between the date of randomization to the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive. OS was followed continuously while participants were on the study drug and every 3 months via in-person or phone contact after participants discontinued the study drug. This interim OS analysis was performed on all randomized subjects when at least 169 events had been observed. Analysis made at Primary Endpoint; Study On-going.|From the date of randomization to the date of death; up to 37 months|All Randomized Participants: All participants randomized to any treatment group||months||95% Confidence Interval|Number
846197|NCT01721746|Primary|Objective Response Rate (ORR)|ORR=number of participants with a Best Overall Response (BOR) of complete response (CR) or partial response (PR) divided by the number of randomized participants and reported as a percentage. BOR was defined as the best response designation, as determined by the independent review committee (IRC), recorded between the date of randomization and the date of objectively documented progression per RECIST 1.1 or the date of subsequent therapy (including tumor-directed radiotherapy and tumor-directed surgery), whichever occurred first. For participants without documented progression or subsequent therapy, all available response designations contributed to the BOR assessment. CR=Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR=At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Analysis made at Primary Endpoint; Study On-going|From date of randomization to the date of objectively documented progression, date of death, or the date of subsequent therapy; approx. 16 months|All Randomized Participants: All participants randomized to any treatment group||percentage of participants||95% Confidence Interval|Number
846217|NCT01710046|Primary|"Percentage of Participants Achieving a Physician's Global Assessment (PGA) Response of Clear or Almost Clear at Week 12"|PGA psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration and scaling across all psoriatic lesions. PGA of Psoriasis scale ranges from 0 (no psoriasis) to 4 (severe disease). â€˜Clearâ€™ and â€œAlmost clearâ€™ includes all participants who were scored as a 0 or 1.|Week 12|FAS||percentage of participants|||Number
847973|NCT00354172|Secondary|Number of Participants (Patients) Who Experienced Relapse by 12 Months|Number of patients who experienced recurrence or progression of disease from the time of transplant.|1 Year Post Transplant|||Participants|||Number
846198|NCT01721759|Primary|Objective Response Rate (ORR) as Assessed by Independent Radiology Review Committee (IRC)|"ORR is defined as the number of participants with best overall response (OR) of confirmed complete response (CR) or partial response (PR) divided by the number of participants who received treatment.
Participants were evaluated for tumor response per RECIST v1.1 for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
The IRC-assessed ORR (using RECIST v1.1, to confirm response and based on the IRC global radiology review after incorporation of on-study clinical data) was estimated using a binomial response rate and its corresponding 2-sided 95% exact confidence intervals using the Clopper-Pearson method."|Day 1 of treatment to approximately 16 months|Participants who received at least 1 dose of study drug||Percentage of participants||95% Confidence Interval|Number
846199|NCT01721759|Secondary|Objective Response Rate (ORR) as Assessed by Investigator|"ORR is defined as the number of participants with best overall response (OR) of confirmed complete response (CR) or partial response (PR) divided by the total number of participants who received treatment.
Participants were evaluated for tumor response per RECIST v1.1 for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Best overall response, ORR, duration of response, and time to response as assessed by investigator were summarized using RECIST v1.1, to confirm response."|Day 1 of treatment to approximately 16 months|Participants who received at least 1 dose of study drug||Percentage of participants||95% Confidence Interval|Number
846200|NCT01721759|Primary|Objective Response Rate (ORR) as Assessed by Independent Radiology Review Committee (IRC)|"ORR is defined as the number of participants with best overall response (OR) of confirmed complete response (CR) or partial response (PR) divided by the number of participants who received treatment.
Participants were evaluated for tumor response per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by Computerized Tomography (CT) or Magnetic Resonance Imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
The IRC-assessed ORR (using RECIST v1.1, to confirm response and based on the IRC global radiology review after incorporation of on-study clinical data) was estimated using a binomial response rate and its corresponding 2-sided 95% exact confidence intervals using the Clopper-Pearson method."|Day 1 of treatment to approximately 19 months|Participants who received at least 1 dose of study drug||Percentage of participants||95% Confidence Interval|Number
846201|NCT01714024|Secondary|Group Based Differences (i.e. Healthy, Osteopenic and Diabetic) in Gene Expression Using Fold Changes Between Titanium and Trabecular at 4 Weeks.|Findings from expression arrays will be used to perform quantitative PCR analyses using SAB Superarrays (SuperArray GEArray), to enable a quantitativeassay of mRNA levels of specific inflammatory and growth factor molecules|4 weeks|||Fold Change||Standard Deviation|Mean
846202|NCT01714024|Primary|Fold Change in Gene Expression Comparing Trabecular Metal to Standard Titanium.|Samples were analyzed comparing the osteogenic potential associated with titanium and porous tantalum dental implants (cylinders) at 2 and 4 weeks using transcriptome analyses. The primary outcome data are displayed showing the Average Delta ∆ (Ct) for osteogenic genes relative to the housekeeping markers. The numerical value of the CT is inversely related to the amount of amplicon in the reaction (i.e., the lower the CT, the greater the amount of amplicon).|2 weeks & 4 weeks post placement|||Average Delta ∆ (Ct)||Standard Deviation|Mean
846203|NCT01710046|Secondary|Percent Change From Baseline in TPSS by Visit|Target lesions were selected at baseline and followed for the duration of the study. Each target lesion was scored by the investigator on severity of erythema, induration, and scaling according to a 5-point (0 to 4) severity scale with a maximum sum score for a plaque of 12. The TPSS was calculated as the sum of the scores for erythema, induration, and scaling; the score can vary in increments of 1 unit from 0 to 12. A negative value indicated improvment.|Weeks 1, 2, 4, and 12|FAS; n=number of participants with nonmissing observations at the specified visit.||percent change from baseline||Standard Error|Mean
846204|NCT01710046|Secondary|Target Plaque Severity Score (TPSS) by Visit|Target lesions were selected at baseline and followed for the duration of the study. Each target lesion was scored by the investigator on severity of erythema, induration, and scaling according to a 5-point (0 to 4) severity scale with a maximum sum score for a plaque of 12. The TPSS was calculated as the sum of the scores for erythema, induration, and scaling; the score can vary in increments of 1 unit from 0 to 12.|Baseline and Weeks 1, 2, 4, and 12|FAS; n=number of participants with nonmissing observations at the specified visit.||score on a scale||Standard Error|Mean
846205|NCT01710046|Secondary|Change From Baseline in ISI by Visit|"ISI, a single-item, horizontal numeric rating scale. Participants were asked to rate your worst itching due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms No itching (0) and Worst possible itching (10) at the ends. The baseline is defined as the average of all available diary entries before Baseline/Day 1 and the in-clinic measurement on Baseline/Day 1. Week 1 is the mean of daily values of study days 2 to 8 and Week 2 is the mean of daily values of study days 9 to 15. A negative value indicates an improvement."|Weeks 1, 2, 4 and 12|FAS; n=number of participants with nonmissing observations at the specified visit.||units on a scale||Standard Error|Mean
846206|NCT01710046|Secondary|Itch Severity Item (ISI) Score by Visit|"The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single-item, horizontal numeric rating scale. Participants were asked to rate your worst itching due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms No itching (0) and Worst possible itching (10) at the ends. the baseline is defined as the average of all available diary entries before Baseline/Day 1 and the in-clinic measurement on Baseline/day 1. Week 1 is the mean of daily values of study days 2 to 8 and Week 2 is the mean of daily values of study days 9 to 15."|Baseline and Weeks 1, 2, 4, and 12|FAS; n=number of participants with nonmissing observations at the specified visit.||units on a scale||Standard Error|Mean
846236|NCT01662440|Secondary|Kinetics of JE Immune Response Measured as PRNT50 GMTs|To evaluate the kinetics of antibody response to JE vaccine, the immunogenicity was measured as the PRNT50 GMTs on days 1, 15, 22, 36, 57, 91, 181, and 366 (group that received JE vaccine as an accelerated schedule) and days 1, 36, 57, 181, and 366 (group that received JE vaccine as a conventional schedule).|Day 1, 15, 22, 36, 57, 91, 181, and 366 (accelerated schedule) and day 1, 36, 57, 181, and 366 (conventional schedule)|Analysis was done on the PP dataset.||Titers||95% Confidence Interval|Geometric Mean
846207|NCT01710046|Secondary|Percent Change From Baseline in BSA|Assessment of BSA with psoriasis was performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The percent surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (ie, the participant's fully extended palm, fingers and thumb together) represents approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region can be used to determine the extent (%) to which a body regions is involved with psoriasis. In each body region, the percent body region surface area with psoriasis is multiplied by the Body Region Weighting (head and neck=10%, upper limbs=5%, trunk [including axillae and groin]=3.33% and lower limbs [including buttocks]=2.5%). BSA (%)=0.1Sh + 0.2Sh+0.3St+0.4Sl, where S=body region suface area with psoriasis: h=head; u=upper limbs; t=trunk; l=lower limbs.|Weeks 1, 2, 4, and 12|FAS; n=number of participants with nonmissing observations at the specified visit.||percent change from baseline||Standard Error|Mean
846208|NCT01710046|Secondary|Change From Baseline in BSA|Assessment of BSA with psoriasis was performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The percent surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (ie, the participant's fully extended palm, fingers and thumb together) represents approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region can be used to determine the extent (%) to which a body regions is involved with psoriasis. In each body region, the percent body region surface area with psoriasis is multiplied by the Body Region Weighting (head and neck=10%, upper limbs=5%, trunk [including axillae and groin]=3.33% and lower limbs [including buttocks]=2.5%). BSA (%)=0.1Sh + 0.2Sh+0.3St+0.4Sl, where S=body region suface area with psoriasis: h=head; u=upper limbs; t=trunk; l=lower limbs.|Weeks 1, 2, 4, and 12|Because Cohort 2 of the study was not conducted and Cohort 1 had a limited number of participants, the analyses were simplified and this analysis was not performed.|||||
846209|NCT01710046|Secondary|Body Surface Area (BSA)|Assessment of BSA with psoriasis was performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The percent surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (ie, the participant's fully extended palm, fingers and thumb together) represents approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region can be used to determine the extent (%) to which a body regions is involved with psoriasis. In each body region, the percent body region surface area with psoriasis is multiplied by the Body Region Weighting (head and neck=10%, upper limbs=5%, trunk [including axillae and groin]=3.33% and lower limbs [including buttocks]=2.5%). BSA (%)=0.1Sh + 0.2Sh+0.3St+0.4Sl, where S=body region suface area with psoriasis: h=head; u=upper limbs; t=trunk; l=lower limbs.|Baseline and Weeks 1, 2, 4, and 12|FAS; n=number of participants with nonmissing observations at the specified visit.||% BSA||Standard Error|Mean
846210|NCT01710046|Secondary|Percentage of Participants by PGA Response Category and Timepoint|PGA psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration and scaling across all psoriatic lesions. PGA of Psoriasis scale ranges from 0 (no psoriasis) to 4 (severe disease). Response category scores: 0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe. The severity scores of 3 components (erythema, induration, and scaling) are averaged and rounded to the nearest whole number to determine the PGA score.|Baseline and Weeks 1, 2, 4, and 12|FAS; n=number of participants with nonmissing observations at the specified visit.||percentage of participants|||Number
846211|NCT01710046|Secondary|Percentage of Participants in Each PGA Category at Various Timepoints by Baseline Category||Baseline and Weeks 1, 2, 4, and 12|Because Cohort 2 of the study was not conducted and Cohort 1 had a limited number of participants, the analyses were simplified and this analysis was not performed.|||||
846212|NCT01710046|Secondary|Change From Baseline in PGA Score by Visit|PGA psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. PGA of Psoriasis scale ranges from 0 (no psoriasis) to 4 (severe disease). The severity scores of 3 components (erythema, induration, and scaling) are averaged and rounded to the nearest whole number to determine the PGA score.|Weeks 1, 2, 4, and 12|FAS; n=number of participants with nonmissing observations at the specified visit.||units on a scale||Standard Error|Mean
846213|NCT01710046|Secondary|Percentage of Participants Achieving a PASI75 Response at Weeks 1, 2, and 4|Combined assessment of lesion severity and area affected into single score; range=0 (no disease) to 72 (maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4) summed over all sections.|Weeks 1, 2, and 4|FAS||percentage of participants|||Number
846214|NCT01710046|Secondary|Percent Change From Baseline in PASI by Visit|Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0= 0% to 6= 90â€“100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4) summed over all sections; total possible score range: 0= no disease to 72= maximal disease.|Weeks 1, 2, 4, and 12|FAS; n=number of participants with nonmissing observations at the specified visit.||percent change from baseline||Standard Error|Mean
846215|NCT01710046|Secondary|Change From Baseline in PASI by Visit|Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0=0% to 6=90â€“100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4) summed over all sections; total possible score range: 0= no disease to 72= maximal disease.|Weeks 1, 2, 4 and 12|Because Cohort 2 of the study was not conducted and Cohort 1 had a limited number of participants, the analyses were simplified and this analysis was not performed.|||||
847974|NCT00354172|Secondary|Number of Participants (Patients) Who Died by 24 Months|Number of patients who died after receiving treatment within 24 months post transplant.|2 years post-transplant|||Participants|||Number
846218|NCT01710046|Primary|Percentage of Participants Achieving a 75% Reduction in the Psoriasis Area and Severity Index (PASI75) at Week 12|Combined assessment of lesion severity and area affected into single score; range equals (=) 0 (no disease) to 72 (maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4) summed over all sections.|Week 12|FAS||percentage of participants|||Number
846221|NCT01680783|Other Pre-specified|Improvement of Oxygenation|Improvement of oxygenation-defined as PaO2/FiO2 ≥ 200 or increase from baseline by 100|2 weeks||||||
846222|NCT01680783|Other Pre-specified|Discharge Location|Measure the location (ie home, rehabilitation center, nursing home) that patients are discharged to|6 weeks||||||
846223|NCT01680783|Other Pre-specified|Readmission to the Intensive Care Unit|Measure the need for readmission to the intensive care unit during initial hospitalization at time of enrollment|6 weeks||||||
846224|NCT01680783|Other Pre-specified|ICU Complications|ICU complications will include rates of Ventilator associated pneumonia, Barotrauma, Gastrointestinal hemorrhage, Pulmonary embolism, Sacral Decubitus ulcer, Delirium, ICU acquired weakness|6 weeks||||||
846225|NCT01680783|Secondary|Intensive Care Unit Length of Stay|Number of days admitted to a medical intensive care unit|4 weeks||||||
846226|NCT01680783|Secondary|Hospital Mortality|Death from any cause during hospitalization at time of enrollment|6 weeks||||||
846227|NCT01680783|Secondary|Ventilator Days|Duration of mechanical ventilation via endotracheal tube|number of days in the hospital||09/2017||||
846228|NCT01680783|Secondary|Functional Status After Discharge|Telephone survey of patients 1, 6, and 12 months after discharge to assess need for re-hospitalization, admission to nursing home, and functional status (ability to complete ADLs and IADLs independently)|Measured at 1, 6, and 12 months after hospital discharge (to span time frame of up to 80 weeks depending on length of hospitalization)||||||
846229|NCT01680783|Secondary|Hospital Length of Stay|Days spent in hospital at time of enrollment|Duration of hospital stay||09/2017||||
846230|NCT01680783|Primary|Need for Endotracheal Intubation|Number of patients requiring endotracheal intubation after application of helmet device|6 weeks|||Participants|||Count of Participants
846231|NCT01662440|Secondary|Numbers of Subjects Reporting Unsolicited AEs After Any Vaccination From Day 1 Through Day 57|Safety was assessed as the number of subjects who reported unsolicited AEs after any vaccination given according to accelerated and conventional schedule.|Day 1 through Day 57|Analysis was done on the unsolicited safety set, ie, the subjects in the exposed population who provided postvaccination unsolicited safety data.||Number of subjects|||Number
846232|NCT01662440|Secondary|Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination|Safety was assessed as the number of subjects who reported solicited systemic AEs and other indicators of reactogenicity after each vaccination given according to accelerated and conventional schedule.|Day 1 through day 7 after each vaccination (day 1, 4, 8 and 29)|Analysis was done on the solicited safety set.||Number of Subjects|||Number
846233|NCT01662440|Secondary|Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection|Safety was assessed as the number of subjects who reported solicited local AEs after each placebo injection given according to accelerated and conventional schedule as follow: from day 1 through day 7 (injection on day 1; R – Conv and JE – Conv groups), day 4 through day 10 (injection on day 4; in R/JE – Conv, R – Conv and JE - Conv groups), day 8 through day 14 (injection on day 8; in R/JE – Conv, R – Conv and JE - Conv groups), and day 29 through day 35 (injection on day 29; R/JE – Acc, R – Con and JE – Conv groups).|Day 1 through day 7 after each injection (day 1, 4, 8 and 29)|Analysis was done on the solicited safety set.||Number of Subjects|||Number
846234|NCT01662440|Secondary|Number of Subjects Who Reported Solicited Local AEs After Each JE Vaccination|Safety was assessed as the number of subjects who reported solicited local AEs after each JE vaccination given according to accelerated or conventional schedule as follow: from day 1 through day 7 (vaccination on day 1; all JE groups), day 8 through day 14 (vaccination on day 8; R/JE – Acc group only), or day 29 through day 35 (vaccination on day 29; R/JE – Con and JE – Conv groups).|Day 1 through day 7 after each vaccination (on day 1, 8 and 29)|Analysis was done on the solicited safety set.||Number of subjects|||Number
846235|NCT01662440|Secondary|Number of Subjects Who Reported Solicited Local Adverse Events After Each Rabies Vaccination|Safety was assessed as the number of subjects who reported solicited local adverse events (AEs) after each rabies vaccination given according to accelerated or conventional schedule as follows: from day 1 through day 7 (vaccination on day 1; all Rabies groups), day 4 through day 10 (vaccination on day 4; in R/JE – Acc group only), day 8 through day 14 (vaccination on day 8; all Rabies groups), or day 29 through day 35 (vaccination on day 29; R/JE – Conv and R – Conv groups).|Day 1 through day 7 after each vaccination (on day 1, 4, 8 and 29)|Analysis was done on the solicited safety set, i.e. the subjects in the exposed population who provided postvaccination solicited safety data.||Number of subjects|||Number
847119|NCT00799617|Secondary|Bone Trial - Bone Strength of Spine Whole Bone by Finite Element Analysis, N|Spine whole bone (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)|1 year (baseline to month 12)|||percentage of change||95% Confidence Interval|Mean
846237|NCT01662440|Secondary|Kinetics of JE Immune Response Measured as Percentage of Subjects With PRNT50 Titers ≥1:10|To evaluate the kinetics of antibody response to JE vaccine, the immunogenicity was measured as the percentage of subjects with PRNT50 titer ≥1:10 on days 1, 15, 22, 36, 57, 91, 181, and 366 (group that received JE vaccine as an accelerated schedule) and days 1, 36, 57, 181, and 366 (group that received JE vaccine as a conventional schedule).|Days 1, 15, 22, 36, 57, 91, 181 and 366|Analysis was done on the PP dataset.||Percentages of subjects||95% Confidence Interval|Number
846238|NCT01662440|Secondary|Kinetics of Rabies Immune Response Measured as the RVNA GMCs|To evaluate the kinetics of antibody response to Rabies vaccine, the immunogenicity was measured as the RVNA GMCs on days 1, 8, 15, 36, 57, 91, 181, and 366.|Day 1, 8, 15, 36, 57, 91, 181, and 366|Analysis was done on the PP dataset.||IU/mL||95% Confidence Interval|Geometric Mean
846239|NCT01662440|Secondary|Kinetics of Rabies Immune Response Measured as Percentage of Subjects With RVNA Concentration ≥0.5 IU/mL|To evaluate the kinetics of antibody response to Rabies vaccine, the immunogenicity was measured as the percentage of subjects with RVNA concentrations ≥0.5 IU/mL on days 1, 8, 15, 36, 57, 91, 181, and 366.|Day 1, 8, 15, 36, 57, 91, 181 and Day 366|Analysis was done on the PP dataset.||Percentages of subjects||95% Confidence Interval|Number
846240|NCT01662440|Secondary|Percentage of Subjects With PRNT50 Titer ≥1:10 At 7 Days After Last Active Vaccination|"Immune response was measured as the percentage of subjects with PRNT50 titer of ≥1:10 7 days after last active vaccination, ie, day 15 for the group that received the accelerated schedule and day 36 for the group that received the conventional schedule.
As per study design, this secondary immunogenicity outcome measure aimed to demonstrate non-inferiority of R/JE – Acc Vs JE – Conv."|Day 15 and day 36 (28 after last active vaccination)|Analysis was done on the PP dataset.||Percentages of subjects||95% Confidence Interval|Number
846241|NCT01662440|Secondary|Percentages of Subjects With RVNA Concentrations ≥0.5 IU/mL At 28 Days After Last Active Vaccination|"Immune response was measured as the percentages of subjects with RVNA concentration ≥0.5 IU/mL 28 days after last active vaccination, ie, day 36 for the group that received the accelerated schedule and day 57 for the group that received the conventional schedule.
As per study design, this secondary immunogenicity outcome measure aimed to demonstrate non-inferiority of R/JE – Acc Vs R – Conv."|Day 36 and day 57 (28 days after last active vaccination)|Analysis was done on the PP set.||Percentages of subjects||95% Confidence Interval|Number
846242|NCT01662440|Secondary|PRNT50 Geometric Mean Titers (GMTs) At 28 Days After Last Active Vaccination|"Immune response was measured as the PRNT50 GMTs 28 days after last active vaccination, ie, day 57 for all groups that received the conventional schedule.
Data were adjusted using ANOVA model, as per protocol specifications."|Day 57 (28 days after last active vaccination)|Analysis was done on the PP dataset.||Titers||95% Confidence Interval|Geometric Mean
846243|NCT01662440|Secondary|RVNA Geometric Mean Concentrations (GMCs) At 28 Days After Last Active Vaccination|"Immune response was measured as the RVNA GMCs 28 days after last active vaccination, ie, day 57 for all groups that received the conventional schedule.
Data were adjusted using ANOVA model, as per protocol specification."|Day 57 (28 days after last active vaccination)|Analysis was done on the PP dataset.||IU/mL||95% Confidence Interval|Geometric Mean
846244|NCT01662440|Primary|Percentages of Subjects With PRNT50 Titer ≥1:10 At 28 Days After Last Active Vaccination|"Immune response was measured as the percentages of subjects with a titer of ≥1:10 in a 50% plaque reduction neutralization test (PRNT50) 28 days after last active vaccination, ie, the second out of three vaccinations given in the accelerated JE vaccine schedule and the third out of three vaccinations given in the conventional JE vaccine schedule.
As per study design, this primary immunogenicity outcome measure aimed to demonstrate non-inferiority of R/JE – Acc Vs JE – Conv."|Day 28 after last active vaccination (day 36 – group that received accelerated schedule, day 57 – group that received conventional schedule)|Analysis was done on the PP dataset.||Percentages of subjects||95% Confidence Interval|Number
846245|NCT01662440|Primary|Percentages of Subjects With RVNA Concentrations ≥0.5 IU/mL At 7 Days After Last Active Vaccination|"Immune response was measured as the percentage of subjects with rabies virus neutralizing antibody (RVNA) concentrations ≥0.5 IU/mL, evaluated using the rapid fluorescent focus inhibition test at day 7 after last active vaccination, i.e. the third out of four vaccinations given in the accelerated Rabies vaccine schedule and the fourth out of four vaccinations given in the conventional Rabies vaccine schedule.
As per study design, this primary immunogenicity outcome measure aimed to demonstrate non-inferiority of R/JE – Acc Vs R – Conv."|Day 7 after last active vaccination (day 15 – group that received accelerated schedule, day 36 – group that received conventional schedule)|Analysis was done on the per-protocol (PP) dataset, ie, the subjects who received the vaccine correctly, provided evaluable serum samples at the relevant time points, and had no major protocol violations as defined prior to unblinding.||Percentages of subjects||95% Confidence Interval|Number
847975|NCT00354172|Secondary|Number of Participants (Patients) Who Died by 12 Months|Number of patients who died after receiving treatment within 12 months post transplant.|1 year Post Transplant|||Participants|||Number
846252|NCT01621802|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed included medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Any SAE = occurrence of SAE regardless of intensity grade or relation to vaccination.|During the entire study period (from Day 0 up to Day 180)|This analysis was performed on Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented.||Participants|||Count of Participants
846253|NCT01621802|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 43-day (Days 0-42) post-vaccination period|This analysis was performed on Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented.||Participants|||Count of Participants
846254|NCT01621802|Secondary|Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits|The number of subjects reporting adverse events resulting in Emergency Room (ER) visits is reported.|During the entire study period (from Day 0 up to Day 180)|This analysis was performed on Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented.||Participants|||Count of Participants
846255|NCT01621802|Secondary|Number of Subjects With New Onset Chronic Diseases (NOCDs)|NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.|During the entire study period (from Day 0 up to Day 180)|This analysis was performed on Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented.||Participants|||Count of Participants
846256|NCT01621802|Secondary|Number of Subjects Reporting Investigator-confirmed Rash|Assessed any rash, varicella-like rash, measles/rubella-like rash, Grade 3, related. Any= occurrence of rash regardless of intensity grade. Grade 3 measles/rubella/varicella-like rash = Rash with more than 150 lesions. Other Grade 3 Rash = Rash that prevented normal, everyday activities. Related= Rash assessed by the investigator as causally related to study vaccination.|During the 43-day (Days 0-42) post-vaccination period|This analysis was performed on Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented. Analysis of the solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e., symptom screen/sheet completed).||Participants|||Count of Participants
846277|NCT01621802|Primary|Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value|Seroresponse was defined as post-vaccination anti-measles virus antibody concentration equal to or above (≥) 200 milli-international Units per milliliter (mIU/mL). Analysis was done in sub-cohorts 1 and 2 only.|42 days post vaccination (At Day 42)|This analysis was performed on According to Protocol (ATP) cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for measles vaccine component, did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.||Participants|||Count of Participants
846257|NCT01621802|Secondary|Number of Subjects Reporting MMR Specific Solicited General Symptoms|Assessed MMR specific symptoms were parotid gland swelling and any suspected signs of meningism including febrile convulsions. Any = occurrence of any general symptoms regardless of their intensity grade or relationship to vaccination. Grade 3 Parotid/salivary gland swelling = Swelling accompanied with general symptoms. Grade 3 Sign of meningism (any suspected signs including febrile convulsions) = An event which prevented normal, everyday activities. Related = symptom assessed by the investigator as causally related to study vaccination.|During the 43-day (Days 0-42) post-vaccination period|This analysis was performed on Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented. Analysis of the solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e., symptom screen/sheet completed).||Participants|||Count of Participants
846258|NCT01621802|Secondary|Number of Subjects Reporting Fever|Any fever = fever ≥ 38°C; Grade 3 fever = fever > 39.5°C; Related = fever assessed by the investigator as causally related to study vaccination.|During the 43-day (Days 0-42) post-vaccination period|This analysis was performed on Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented. Analysis of the solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e., symptom screen/sheet completed).||Participants|||Count of Participants
846259|NCT01621802|Secondary|Number of Subjects With Solicited General Symptoms|"Assessed solicited general symptoms were drowsiness and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 Drowsiness = Drowsiness that prevented normal activity, Grade 3 Loss of appetite = Not eating at all. Related = symptom assessed by the investigator as causally related to study vaccination.
Analysis was done for sub-cohort 1 only."|During the 4-day (Days 0-3) post-vaccination period|This analysis was performed on Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented. Analysis of the solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e., symptom screen/sheet completed).||Participants|||Count of Participants
846260|NCT01621802|Secondary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 Pain = Cried when limb was moved/spontaneously painful. Grade 3 redness and swelling = greater than 50 millimeters (m m ) i.e . > 50mm.|During the 4-day (Days 0-3) post-vaccination period|This analysis was performed on Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented. Analysis of the solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e., symptom screen/sheet completed).||Participants|||Count of Participants
846261|NCT01621802|Secondary|Evaluation of Immunogenicity in Terms of Anti-polio Virus Types 1, 2 and 3 Antibody Titers|Antibody titers were expressed as Geometric Mean Titers (GMTs) in ED50. Analysis was done in sub-cohort 1 only.|42 days post vaccination (At Day 42)|This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.||ED50||95% Confidence Interval|Geometric Mean
846262|NCT01621802|Secondary|Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 1.0 IU/mL|Analysis was done in sub-cohort 1 only.|42 days post vaccination (At Day 42)|This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.||Participants|||Count of Participants
846263|NCT01621802|Secondary|Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL|Analysis was done in sub-cohort 1 only.|42 days post vaccination (At Day 42)|This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.||Participants|||Count of Participants
846264|NCT01621802|Secondary|Evaluation of Immunogenicity in Terms of Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations|Antibody concentrations were expressed as GMCs in EU/mL. Analysis was done in sub-cohort 1 only.|42 days post vaccination (At Day 42)|This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.||EU/mL||95% Confidence Interval|Geometric Mean
846265|NCT01621802|Secondary|Evaluation of Immunogenicity in Terms of Anti-D and Anti-T Antibody Concentrations|Antibody concentrations were expressed as GMCs in IU/mL. Analysis was done in sub-cohort 1 only.|42 days post vaccination (At Day 42)|This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.||IU/mL||95% Confidence Interval|Geometric Mean
846266|NCT01621802|Secondary|Number of Subjects With Antibody Booster Response to Pertactin (PRN)|"Booster response was defined as:
For initially seronegative subjects, antibody concentration ≥ 8.748 IU/mL at Day 42.
For initially seropositive subjects with pre-vaccination antibody concentration < 8.748 IU/mL: antibody concentration at Day 42 ≥ 4 fold the pre-vaccination antibody concentration.
For initially seropositive subjects with pre-vaccination antibody concentration ≥ 8.748 IU/mL: antibody concentration at Day 42 ≥ 2 fold the pre-vaccination antibody concentration.
Analysis was done in sub-cohort 1 only."|42 days post vaccination (At Day 42)|This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.||Participants|||Count of Participants
846267|NCT01621802|Secondary|Number of Subjects With Antibody Booster Response to Filamentous Hemagglutinin (FHA)|"Booster response was defined as:
For initially seronegative subjects, antibody concentration ≥ 8.184 IU/ml at Day 42.
For initially seropositive subjects with pre-vaccination antibody concentration < 8.184 IU/mL: antibody concentration at Day 42 ≥ 4 fold the pre-vaccination antibody concentration.
For initially seropositive subjects with pre-vaccination antibody concentration ≥ 8.184 IU/mL: antibody concentration at Day 42 ≥ 2 fold the pre-vaccination antibody concentration.
Analysis was done in sub-cohort 1 only."|42 days post vaccination (At Day 42)|This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.||Participants|||Count of Participants
846268|NCT01621802|Secondary|Number of Subjects With Antibody Booster Response to Pertussis Toxin (PT)|"Booster response was defined as:
For initially seronegative subjects, antibody concentration ≥ 10.772 IU/mL at Day 42.
For initially seropositive subjects with pre-vaccination antibody concentration < 10.772 IU/mL: antibody concentration at Day 42 ≥ 4 fold the pre-vaccination antibody concentration.
For initially seropositive subjects with pre-vaccination antibody concentration ≥ 10.772 IU/mL: antibody concentration at Day 42 ≥ 2 fold the pre-vaccination antibody concentration.
Analysis was done in sub-cohort 1 only."|42 days post vaccination (At Day 42)|This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.||Participants|||Count of Participants
846269|NCT01621802|Secondary|Number of Subjects With Antibody Booster Response to Diphtheria Toxin (Anti-D) and Tetanus Toxin (Anti-T)|"Booster response was defined as:
For subjects with pre-vaccination antibody concentration less than (<) 0.1 IU/mL, antibody concentration ≥ 0.4 IU/ml at Day 42.
For subjects with pre-vaccination antibody concentration ≥ 0.1 IU/mL: antibody concentration at Day 42 ≥ 4 fold the pre-vaccination antibody concentration.
Analysis was done in sub-cohort 1 only."|42 days post vaccination (At Day 42)|This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.||Participants|||Count of Participants
846270|NCT01621802|Secondary|Evaluation of Immunogenicity in Terms of Anti-VZV Antibody Concentrations|Antibody concentrations were expressed as GMCs in mIU/mL. Analysis was done in sub-cohort 1 only.|42 days post vaccination (At Day 42)|This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.||mIU/mL||95% Confidence Interval|Geometric Mean
846271|NCT01621802|Secondary|Number of Subjects With Anti-varicella Zoster Virus (VZV) Antibody Concentration Equal to or Above the Cut-off-value|Seroresponse was defined as post-vaccination anti-VZV antibody concentration ≥ 75 mIU/mL. Analysis was done in sub-cohort 1 only.|42 days post vaccination (At Day 42)|This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.||Participants|||Count of Participants
846272|NCT01621802|Primary|Evaluation of Immunogenicity in Terms of Anti-rubella Virus Antibody Concentrations|Antibody concentrations were expressed as GMCs in IU/mL. Analysis was done in sub-cohorts 1 and 2 only.|42 days post vaccination (At Day 42)|This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for rubella vaccine component, did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.||IU/mL||95% Confidence Interval|Geometric Mean
846273|NCT01621802|Primary|Evaluation of Immunogenicity in Terms of Anti-mumps Virus Antibody Concentrations|Antibody concentrations were expressed as GMCs in EU/mL. Analysis was done in sub-cohorts 1 and 2 only.|42 days post vaccination (At Day 42)|This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for mumps vaccine component, did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.||EU/mL||95% Confidence Interval|Geometric Mean
846274|NCT01621802|Primary|Evaluation of Immunogenicity in Terms of Anti-measles Virus Antibody Concentrations|Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. Analysis was done in sub-cohorts 1 and 2 only.|42 days after vaccination (At Day 42)|This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for measles vaccine component, did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.||mIU/mL||95% Confidence Interval|Geometric Mean
846275|NCT01621802|Primary|Number of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value|Seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥ 10 International Units per milliliter (IU/mL). Analysis was done in sub-cohorts 1 and 2 only.|42 days post vaccination (At Day 42)|This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for rubella vaccine component, did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.||Participants|||Count of Participants
846276|NCT01621802|Primary|Number of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value|Seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥ 10 ELISA Units per milliliter (EU/mL). Analysis was done in sub-cohorts 1 and 2 only.|42 days post vaccination (At Day 42)|This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for mumps vaccine component, did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.||Participants|||Count of Participants
853455|NCT00818779|Secondary|Serum Level of Nitric Oxide|Surrogate biomarker of cardiovascular risk|6 week (change from baseline)|||mmmol/l||95% Confidence Interval|Mean
853456|NCT00818779|Secondary|Serum Level of C-reactive Protein|Surrogate biomarker of cardiovascular risk|6 week (change from baseline)|||mg/l||95% Confidence Interval|Mean
853457|NCT00818779|Secondary|Serum Level of Intracellular Cell Adhesion Molecule|Surrogate biomarker of cardiovascular risk|6 week (change from baseline)|||ng/ml||95% Confidence Interval|Mean
853458|NCT00818779|Secondary|Serum Level of Vascular Cell Adhesion Molecule|Surrogate biomarker cardiovascular risk|6 week (change from baseline)|||ng/ml||95% Confidence Interval|Mean
853459|NCT00818779|Primary|Plasminogen Activator Inhibitor 1|Plasminogen Activator Inhibitor 1 is a biomarker found in serum that indirectly assesses blood clotting activity. Lower PAI-1 levels are thought to be better than higher levels. The primary outcome is mean change from baseline and can include negative numbers as a result.|6 weeks (change from baseline)|||ng/ml||95% Confidence Interval|Mean
848366|NCT00073073|Secondary|Effect of This Drug on Serum Hormones, Insulin-like Growth Factor Pathway Components, and Leptin at 3 Months and 1 Year||3 months and 1 year|Data were not collected|||||
846326|NCT01600716|Other Pre-specified|Duration of Treatment Effect Through Week 52|The duration of treatment effect is the time to patient request for retreatment.|Up to 52 Weeks|Intent-to-Treat Population: all randomized patients||Weeks||95% Confidence Interval|Median
846327|NCT01600716|Secondary|Change From Baseline in Incontinence Quality of Life Instrument (I-QOL) Total Summary Score|The I-QOL is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL, and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0=worst QOL and 100=best QOL). A positive change from baseline represents an improvement and a negative change from baseline represents a worsening.|Baseline, Week 6|Intent-to-Treat Population: all randomized patients with data at the time points||Scores on a Scale||Standard Deviation|Mean
846328|NCT01600716|Secondary|Change From Baseline in Maximum Detrusor Pressure During the First Involuntary Detrusor Contraction (IDC)|Maximum detrusor pressure represents the maximum pressure (peak amplitude) in the bladder during the first involuntary contraction of the bladder muscle. A negative number change from baseline indicates an improvement in pressure and a positive number change from baseline indicates a worsening in pressure.|Baseline, Week 6|Intent-to-Treat Population: all randomized patients with data at the time points||Centimeters of Water (cm H2O)||Standard Deviation|Mean
846329|NCT01600716|Secondary|Change From Baseline in Maximum Cystometric Capacity (MCC)|MCC represents the maximum volume of urine the bladder holds. A positive number change from baseline represents an improvement (increase) in the maximum volume of urine the bladder holds and a negative number change from baseline represents a worsening (decrease) in the maximum volume of urine the bladder holds.|Baseline, Week 6|Intent-to-Treat Population: all randomized patients with data at the time points||Milliliters (mL)||Standard Deviation|Mean
846330|NCT01600716|Primary|Change From Baseline in Daily Average Frequency of Urinary Incontinence Episodes|Incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary. The number of episodes of urinary incontinence is recorded over a 3-day period the week of the study visit. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change indicates an increase in incontinence episodes (worsening).|Baseline, Week 6|Intent-to-Treat Population: all randomized patients||Episodes||Standard Deviation|Mean
846333|NCT01570192|Secondary|Mortality|Percentage of patients who died by efficacy endpoint, treatment group and population (n/N)|28 days|The ME population, 19 subjects were analyzed and the m-MITT population, 24 were analyzed. Not all subjects were evaluable for each endpoint.||Participants|||Count of Participants
846334|NCT01570192|Secondary|Mortality|Percentage of patients who died by efficacy endpoint, treatment group and population (n/N)|14 days|The ME population, 19 subjects were analyzed and the m-MITT population, 24 were analyzed. Not all subjects were evaluable for each endpoint.||Participants|||Count of Participants
846335|NCT01570192|Secondary|Occurrence of Repeat Negative Cultures|Percentage of patients with successful responses by efficacy endpoint, treatment group and population (n/N)|Day 5/Early Extubation|The ME population, 19 subjects were analyzed and the m-MITT population, 24 were analyzed. Not all subjects were evaluable for each endpoint.||Participants|||Count of Participants
846336|NCT01570192|Secondary|Suppression of the Emergence of Resistance in Other Gram-negative Pathogens|Percentage of patients with successful responses by efficacy endpoint, treatment group and population (n/N)|Day 5/Early Extubation|The ME population, 19 subjects were analyzed and the m-MITT population, 24 were analyzed. Not all subjects were evaluable for each endpoint.||Participants|||Count of Participants
846337|NCT01570192|Secondary|Pretreatment Pathogen Response|Percentage of patients with successful responses by efficacy endpoint, treatment group and population (n/N)|End of treatment - up to 28 days after enrollment|The ME population, 19 subjects were analyzed and the m-MITT population, 24 were analyzed. Not all subjects were evaluable for each endpoint.||Participants|||Count of Participants
846338|NCT01570192|Secondary|Overall Microbiologic Response|Percentage of patients with successful responses by efficacy endpoint, treatment group and population (n/N)|End of treatment - up to 28 days after enrollment|The ME population, 19 subjects were analyzed and the m-MITT population, 24 were analyzed. Not all subjects were evaluable for each endpoint.||Participants|||Count of Participants
846339|NCT01570192|Secondary|Clinical Response in Subjects Who Received Prior Antibiotics|Percentage of patients with successful responses by efficacy endpoint, treatment group and population (n/N)|End of treatment - up to 28 days after enrollment|The ME population, 19 subjects were analyzed and the m-MITT population, 24 were analyzed. Not all subjects were evaluable for each endpoint.||Participants|||Count of Participants
846340|NCT01570192|Secondary|Clinical Response|Percentage of patients with successful responses by efficacy endpoint, treatment group and population (n/N)|End of treatment - up to 28 days after enrollment|The ME population, 19 subjects were analyzed and the m-MITT population, 24 were analyzed. Not all subjects were evaluable for each endpoint.||Participants|||Count of Participants
846341|NCT01570192|Primary|Number of Participants With Suppression and Emergence of Resistance|The emergence of resistance is defined as a change of meropenem MIC or aminoglycoside MIC by two tube dilutions (fourfold) from baseline when assessed at the second BAL procedure on day 5/early extubation. Patients are evaluable for this endpoint IF they had baseline BAL and Day 5/early extubation and if they had positive cultures on baseline and Day/EE.|up to 28 days after enrollment|All patients in the ME population with BAL at baseline and at Day 5/EE and pathogens collected at baseline BAL and at Day 5/EE BAL.||participants|||Number
846342|NCT01547299|Secondary|Number of Patients With Adverse Events (AEs) That Led to Dose Interruption, Dose Reduction, and Study Drug Discontinuation|To assess the number of patients with AEs that led to permanent discontinuation of enzalutamide, temporary interruption of enzalutamide, dose reduction of enzalutamide, or study drug (enzalutamide, leuprolide, or dutasteride) discontinuation.|6 months|All patients who received at least one partial dose of enzalutamide.||patients|||Number
846343|NCT01547299|Secondary|Change From Baseline in Serum Testosterone|To determine serum hormone effects as measured by change in testosterone at baseline and at completion of therapy.|Baseline, 6 months|All patients randomly assigned to study treatment (intent-to-treat population) with a serum testosterone result at baseline and 6 months postbaseline.||ng/mL||Full Range|Median
846344|NCT01547299|Secondary|Serum Testosterone: 6 Months Postbaseline||6 months|All patients randomly assigned to study treatment (intent-to-treat population) with a 6 month postbaseline serum testosterone result.||ng/mL||Full Range|Median
846346|NCT01547299|Secondary|Change From Baseline in Serum Dihydrotestosterone (DHT)|To determine serum hormone effects as measured by change in DHT values from baseline to the completion of therapy.|Baseline, 6 months|All patients randomly assigned to study treatment (intent-to-treat population) with a serum DHT result at baseline and 6 months postbaseline.||ng/mL||Full Range|Median
846347|NCT01547299|Secondary|Serum Dihydrotestosterone (DHT): 6 Months Postbaseline||6 months|All patients randomly assigned to study treatment (intent-to-treat population) with a 6 month postbaseline serum DHT result.||ng/mL||Full Range|Median
846348|NCT01547299|Secondary|Serum Dihydrotestosterone (DHT): Baseline||Baseline|All patients randomly assigned to study treatment (intent-to-treat population) with a baseline serum DHT result.||ng/mL||Full Range|Median
846349|NCT01547299|Secondary|Pharmacodynamic Effects: Assessment of Androgen Receptor Signaling|To determine the effects of triplet therapy and enzalutamide alone on androgen receptor signaling in prostatectomy specimens.|6 months||08/2015||||
846350|NCT01547299|Secondary|Pharmacodynamic Effects: Assessment of Mitotic Index|To determine the effects of triplet therapy and enzalutamide alone on mitotic index (rate of cell growth) in prostatectomy specimens.|6 months||08/2015||||
846351|NCT01547299|Secondary|Pharmacodynamic Effects: Assessment of Apoptosis|"To determine the effects of triplet therapy and enzalutamide alone on apoptosis in prostatectomy specimens.
Assessment of apoptosis was not performed due to limited amounts of tissue available."|6 months||||||
846352|NCT01547299|Secondary|Pharmacodynamic Effects: Tissue Testosterone|To determine pharmacodynamic effects as measured by tissue testosterone in prostatectomy specimens following radical prostatectomy.|6 months|All patients randomly assigned to study treatment (intent-to-treat population) with a prostatectomy sample evaluated by the central pathologist.||pg/mg||Full Range|Median
846353|NCT01547299|Secondary|Pharmacodynamic Effects: Tissue Dihydrotestosterone (DHT)|To determine pharmacodynamic effects as measured by tissue DHT in prostatectomy specimens following radical prostatectomy.|6 months|All patients randomly assigned to study treatment (intent-to-treat population) with a prostatectomy sample evaluated by the central pathologist.||pg/mg||Full Range|Median
846354|NCT01547299|Secondary|Health-Related Quality of Life (HRQoL): The Twelve-Item Short Form Version 2 Mental Component Summary|The Twelve-Item Short Form Version 2 is an HRQoL instrument that measures general health and well-being across physical and mental components. Best change from baseline category in mental component summary is summarized below. Categories are worsened (decrease of at least 1 minimally important difference), stable (changed by less than 1 minimally important difference), or improved (increase of at least 1 minimally important difference). Minimally important difference is defined as one-half the standard deviation of the score of interest at baseline.|6 months|All patients randomly assigned to study treatment (intent-to-treat population) with a baseline and at least one postbaseline score.||patients|||Number
846355|NCT01547299|Secondary|Health-Related Quality of Life (HRQoL): The Twelve-Item Short Form Version 2 Role-Emotional Domain Score|The Twelve-Item Short Form Version 2 is an HRQoL instrument that measures general health and well-being across physical and mental components. Best change from baseline category in role-emotional domain score is summarized below. Categories are worsened (decrease of at least 1 minimally important difference), stable (changed by less than 1 minimally important difference), or improved (increase of at least 1 minimally important difference). Minimally important difference is defined as one-half the standard deviation of the score of interest at baseline.|6 months|All patients randomly assigned to study treatment (intent-to-treat population) with a baseline and at least one postbaseline score.||patients|||Number
846356|NCT01547299|Secondary|Health-Related Quality of Life (HRQoL): The Twelve-Item Short Form Version 2 Physical Functioning Domain Score|The Twelve-Item Short Form Version 2 is an HRQoL instrument that measures general health and well-being across physical and mental components. Best change from baseline category in physical functioning domain score is summarized below. Categories are worsened (decrease of at least 1 minimally important difference), stable (changed by less than 1 minimally important difference), or improved (increase of at least 1 minimally important difference). Minimally important difference is defined as one-half the standard deviation of the score of interest at baseline.|6 months|All patients randomly assigned to study treatment (intent-to-treat population) with a baseline and at least one postbaseline score.||patients|||Number
846357|NCT01547299|Secondary|Health-Related Quality of Life (HRQoL): The Twelve-Item Short Form Version 2 General Health Domain Score|The Twelve-Item Short Form Version 2 is an HRQoL instrument that measures general health and well-being across physical and mental components. Best change from baseline category in general health domain score is summarized below. Categories are worsened (decrease of at least 1 minimally important difference), stable (changed by less than 1 minimally important difference), or improved (increase of at least 1 minimally important difference). Minimally important difference is defined as one-half the standard deviation of the score of interest at baseline.|6 months|All patients randomly assigned to study treatment (intent-to-treat population) with a baseline and at least one postbaseline score.||patients|||Number
846358|NCT01547299|Secondary|Health-Related Quality of Life (HRQoL): The Expanded Prostate Cancer Index Composite (EPIC) Hormonal Bother Subscale Score|EPIC Hormonal Domain is an HRQoL instrument that measures the effects of prostate cancer treatment on a patient's hormonal function. Best change from baseline category in EPIC hormonal bother subscale score is summarized below. Categories are worsened (decrease of at least 1 minimally important difference), stable (changed by less than 1 minimally important difference), or improved (increase of at least 1 minimally important difference). Minimally important difference is defined as one-half the standard deviation of the score of interest at baseline.|6 months|All patients randomly assigned to study treatment (intent-to-treat population) with a baseline and at least one postbaseline score.||patients|||Number
846359|NCT01547299|Secondary|Health-Related Quality of Life (HRQoL): The Expanded Prostate Cancer Index Composite (EPIC) Hormonal Function Subscale Score|EPIC Hormonal Domain is an HRQoL instrument that measures the effects of prostate cancer treatment on a patient's hormonal function. Best change from baseline category in EPIC hormonal function subscale score is summarized below. Categories are worsened (decrease of at least 1 minimally important difference), stable (changed by less than 1 minimally important difference), or improved (increase of at least 1 minimally important difference). Minimally important difference is defined as one-half the standard deviation of the score of interest at baseline.|6 months|All patients randomly assigned to study treatment (intent-to-treat population) with a baseline and at least one postbaseline score.||patients|||Number
846360|NCT01547299|Secondary|Health-Related Quality of Life (HRQoL): The Expanded Prostate Cancer Index Composite (EPIC) Hormonal Domain Summary Score|EPIC Hormonal Domain is an HRQoL instrument that measures the effects of prostate cancer treatment on a patient's hormonal function. Best change from baseline category in EPIC hormonal domain summary score is summarized below. Categories are worsened (decrease of at least 1 minimally important difference), stable (changed by less than 1 minimally important difference), or improved (increase of at least 1 minimally important difference). Minimally important difference is defined as one-half the standard deviation of the score of interest at baseline.|6 months|All patients randomly assigned to study treatment (intent-to-treat population) with a baseline and at least one postbaseline score.||patients|||Number
846361|NCT01547299|Secondary|Health-Related Quality of Life (HRQoL): The Expanded Prostate Cancer Index Composite (EPIC) Sexual Bother Subscale Score|EPIC Sexual Domain is an HRQoL instrument that measures the effects of prostate cancer treatment on a patient's sexual function and sexual satisfaction. Best change from baseline category in EPIC sexual bother subscale score is summarized below. Categories are worsened (decrease of at least 1 minimally important difference), stable (changed by less than 1 minimally important difference), or improved (increase of at least 1 minimally important difference). Minimally important difference is defined as one-half the standard deviation of the score of interest at baseline.|6 months|All patients randomly assigned to study treatment (intent-to-treat population) with a baseline and at least one postbaseline score.||patients|||Number
846362|NCT01547299|Secondary|Health-Related Quality of Life (HRQoL): The Expanded Prostate Cancer Index Composite (EPIC) Sexual Function Subscale Score|EPIC Sexual Domain is an HRQoL instrument that measures the effects of prostate cancer treatment on a patient's sexual function and sexual satisfaction. Best change from baseline category in EPIC sexual function subscale score is summarized below. Categories are worsened (decrease of at least 1 minimally important difference), stable (changed by less than 1 minimally important difference), or improved (increase of at least 1 minimally important difference). Minimally important difference is defined as one-half the standard deviation of the score of interest at baseline.|6 months|All patients randomly assigned to study treatment (intent-to-treat population) with a baseline and at least one postbaseline score.||patients|||Number
846363|NCT01547299|Secondary|Health-Related Quality of Life (HRQoL): The Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain Summary Score|EPIC Sexual Domain is an HRQoL instrument that measures the effects of prostate cancer treatment on a patient's sexual function and sexual satisfaction. Best change from baseline category in EPIC sexual domain summary score is summarized below. Categories are worsened (decrease of at least 1 minimally important difference), stable (changed by less than 1 minimally important difference), or improved (increase of at least 1 minimally important difference). Minimally important difference is defined as one-half the standard deviation of the score of interest at baseline.|6 months|All patients randomly assigned to study treatment (intent-to-treat population) with a baseline and at least one postbaseline score.||patients|||Number
846364|NCT01547299|Secondary|Percentage of Patients With Reduction in Prostate-Specific Antigen (PSA)|To determine the effects on PSA as measured by the percentage of patients with PSA < 0.2 ng/mL, and a 50% and 90% decrease in PSA value prior to prostatectomy.|6 months|All patients randomly assigned to study treatment (intent-to-treat population) with a baseline PSA and at least one postbaseline PSA.||percentage of patients||95% Confidence Interval|Number
846365|NCT01547299|Secondary|Time to Prostate-Specific Antigen (PSA) Nadir|To determine the effects on PSA as measured by the time to the lowest postbaseline PSA value prior to prostatectomy.|6 months|All patients randomly assigned to study treatment (intent-to-treat population) with a baseline PSA and at least one postbaseline PSA.||months||Full Range|Median
846366|NCT01547299|Secondary|Prostate-Specific Antigen (PSA) Nadir|To determine the effects on PSA as measured by the lowest postbaseline PSA value prior to prostatectomy.|6 months|All patients randomly assigned to study treatment (intent-to-treat population) with a baseline PSA and at least one postbaseline PSA.||µg/L||Full Range|Median
846367|NCT01547299|Secondary|Percentage of Patients With Positive Lymph Nodes|To determine the percentage of patients with positive lymph nodes at prostatectomy as assessed by the local and central pathologist.|6 months|All patients randomly assigned to study treatment (intent-to-treat population) with a prostatectomy sample evaluated by the local and central pathologist.||percentage of patients||95% Confidence Interval|Number
846368|NCT01547299|Secondary|Percentage of Patients With Positive Seminal Vesicles|To determine the percentage of patients with positive seminal vesicles at prostatectomy as assessed by the local and central pathologist.|6 months|All patients randomly assigned to study treatment (intent-to-treat population) with a prostatectomy sample evaluated by the local and central pathologist.||percentage of patients||95% Confidence Interval|Number
846369|NCT01547299|Secondary|Percentage of Patients With Extracapsular Extension: Central Review|To determine the percentage of patients with extracapsular extension at prostatectomy as assessed by the central pathologist.|6 months|All patients randomly assigned to study treatment (intent-to-treat population) with a prostatectomy sample evaluated by the central pathologist. One patient in the Enzalutamide alone treatment arm was excluded from the analysis because the result reported by the central lab was indeterminate.||percentage of patients||95% Confidence Interval|Number
846370|NCT01547299|Secondary|Percentage of Patients With Extracapsular Extension: Local Review|To determine the percentage of patients with extracapsular extension at prostatectomy as assessed by the local pathologist.|6 months|All patients randomly assigned to study treatment (intent-to-treat population) with a prostatectomy sample evaluated by the local pathologist.||percentage of patients||95% Confidence Interval|Number
846371|NCT01547299|Secondary|Percentage of Patients With Positive Surgical Margins|To determine the percentage of patients with positive surgical margins at prostatectomy as assessed by the local and central pathologist.|6 months|All patients randomly assigned to study treatment (intent-to-treat population) with a prostatectomy sample evaluated by the local and central pathologist.||percentage of patients||95% Confidence Interval|Number
846393|NCT01453348|Secondary|Percentages of Subjects With Unsolicited Adverse Events (AEs)|Safety was assessed in terms of percentage of all spontaneously reported AEs collected from the time the subject signed the informed consent form (day 1), until the subject stopped study participation (day 57).|Day 1 to day 57.|Analysis was done on safety set- subjects who provided any post-baseline safety data.||percentage of subjects|||Number
848367|NCT00073073|Secondary|Change in Breast Density at 2 Years||2 years|||percent change from baseline||95% Confidence Interval|Mean
846372|NCT01547299|Primary|Pathologic Complete Response Rate|Pathologic complete response rate following triplet therapy (enzalutamide in combination with leuprolide and dutasteride) and enzalutamide alone when administered as neoadjuvant therapy for 6 months prior to prostatectomy in patients with localized prostate cancer. Pathologic complete response is defined as the absence of morphologically identifiable carcinoma in the prostatectomy specimen, as evaluated by the site pathologist using standard methods.|6 months|All patients randomly assigned to study treatment (intent-to-treat population) with a prostatectomy sample evaluated by the local and central pathologist.||percentage of patients||95% Confidence Interval|Number
846379|NCT01466387|Secondary|Number of Subjects With Adverse Events of Special Interest After Any Vaccination of Japanese Encephalitis and Rabies Virus Vaccines Given Concomitantly With MenACWY-CRM197 or Alone|In addition to the AEs and SAEs. Additional AESI were collected from day 1 to day 57 postvaccination in subjects after the vaccination of Japanese encephalitis and rabies virus vaccines given concomitantly with MenACWY-CRM197 or alone.|day 1 to day 57 post last vaccination|Analysis was done on the safety data set, i.e. the subjects in the exposed population who provided postvaccination safety data.||subjects|||Number
846380|NCT01466387|Secondary|Percentages of Subjects With Anti-rabies Virus Concentrations ≥ 0.5 IU/mL, 28 Days After the Last Vaccination of Rabies Virus Vaccine Concomitantly Either With Japanese Encephalitis or With Japanese Encephalitis and MenACWY-CRM197|"Immunogenicity was measured as the percentages of subjects who achieved seroprotection of anti-rabies virus antibody concentrations 28 days after vaccination of the third dose of rabies virus vaccine, when administered alone or concomitantly either with Japanese encephalitis or with Japanese encephalitis and MenACWY-CRM197 vaccines.
Seroprotection is defined as percentages of subjects who achieved anti-rabies virus antibody concentrations ≥ 0.5 IU/mL on day 57."|Baseline and 1 month post last vaccination (day 57).|The analysis was done on the MITT data set.||Percentages of subjects||95% Confidence Interval|Number
846381|NCT01466387|Secondary|Geometric Mean Rabies Virus Neutralizing Antibody Concentration 28 Days After the Last Vaccination Of Rabies Virus Vaccine Concomitantly Either With Japanese Encephalitis or With Japanese Encephalitis And MenACWY-CRM197|The immunogenicity was assessed in rabies virus vaccine as measured by geometric mean rabies virus neutralizing antibody concentration, 28 days after vaccination of the third dose, when administered alone or concomitantly either with Japanese encephalitis vaccine or with Japanese Encephalitis and MenACWY-CRM197 vaccines.|Baseline and 1 month post last vaccination (day 57).|The analysis was done on the MITT data set.||IU/mL||95% Confidence Interval|Geometric Mean
846382|NCT01466387|Secondary|Seroresponse Rate for Meningococcal Serogroups A,C,W,Y 28 Days After Vaccination of MenACWY-CRM197 Given Concomitantly With Japanese Encephalitis and Rabies Virus Vaccines or Alone|"Immunogenicity was assessed by seroresponse rates as measured by human serum bactericidal activity (hSBA) titers for meningococcal serogroups A,C,W,Y 28 days after administration of MenACWY-CRM197 given concomitantly with Japanese encephalitis and rabies virus vaccines or alone.
Seroresponse is defined as a subject with a baseline hSBA titer < 1:4, seroresponse was defined as a post-vaccination hSBA titer ≥ 1:8; for a subject with a baseline hSBA titer ≥ 1:4, seroresponse was defined as a postvaccination hSBA titer of at least 4 times the baseline."|1 month post last vaccination (day 29 or day 57)|The analysis was done on the MITT data set.||Percentages of subjects||95% Confidence Interval|Number
846383|NCT01466387|Secondary|Geometric Mean hSBA Titers for Meningococcal Serogroups A,C,W,Y 28 Days After the Vaccination of MenACWY-CRM197 Given Concomitantly With Japanese Encephalitis and Rabies Virus Vaccines or Alone|Immunogenicity was measured by human serum bactericidal activity (hSBA) geometric mean titers (GMTs) for meningococcal serogroups A,C,W,Y 28 days after administration of MenACWY-CRM197 given concomitantly with Japanese encephalitis and rabies virus vaccines or alone.|Baseline and 1 month post last vaccination (day 29 or day 57).|The analysis was done on the MITT data set.||titers||95% Confidence Interval|Geometric Mean
846394|NCT01453348|Secondary|hSBA GMTs Assay Titers Against N Meningitidis A, C, W and Y Serogroups at Day 29|Immunogenicity was assessed in terms of geometric mean titers (GMTs) of antibodies to meningococcal serogroups A, C, W and Y on day 29 when given concomitantly with combined hepatitis A/B vaccine or given alone.|28 days post vaccination (day 29).|Analysis was done on modified intention-to-treat (MITT) population- subjects who provided evaluable serum samples whose assay results are available for at least one antigen on visit day 1 and a post baseline visit.||Titers||95% Confidence Interval|Geometric Mean
846384|NCT01466387|Secondary|Seroresponse Rate For Meningococcal Serogroups A,C,W,Y 28 Days After Vaccination of MenACWY-CRM197 Given Concomitantly With Typhoid Vi Polysaccharide and Yellow Fever Vaccines or Alone|"Immunogenicity was assessed by seroresponse rates as measured by human serum bactericidal activity (hSBA) titers for meningococcal serogroups A,C,W,Y 28 days after administration of MenACWY-CRM197 given concomitantly with typhoid Vi polysaccharide and yellow fever vaccines or alone.
Seroresponse is defined as a postvaccination hSBA titer ≥1:8; for a subject with a baseline hSBA titer ≥1:4, seroresponse is defined as a postvaccination hSBA titer of at least four times the baseline."|1 month postvaccination (day 29)|The analysis was done on the MITT data set.||Percentages of subjects||95% Confidence Interval|Number
846385|NCT01466387|Secondary|Geometric Mean hSBA Titers For Meningococcal Serogroups A,C,W,Y 28 Days After The Vaccination Of MenACWY-CRM197 Given Concomitantly With Typhoid Vi Polysaccharide And Yellow Fever Vaccines Alone|Immunogenicity was assessed by Serum Bactericidal Assay using human complement (hSBA) geometric mean titers (GMTs) for meningococcal serogroups A,C,W,Y 28 days after administration of MenACWY-CRM197 given concomitantly with typhoid Vi polysaccharide and yellow fever vaccines or alone.|Baseline and 1 month postvaccination (day 29).|Analysis was done on the MITT data set.||titers||95% Confidence Interval|Geometric Mean
846386|NCT01466387|Secondary|Percentages Of Subjects With Anti-Rabies Virus Antibody Concentrations ≥ 0.5 IU/mL 28 Days After the Vaccination Of The Last Doses Of Japanese Encephalitis And Rabies Virus, Given Concomitantly With MenACWY-CRM197 Or Alone|"Immunogenicity was assessed as the percentages of subjects who achieved seroprotection as measured by neutralization test for anti-rabies neutralizing antibody titers, 28 days after administration of the second dose of Japanese encephalitis virus vaccine and 28 days after the vaccination of third dose of rabies virus vaccine, given alone or concomitantly with MenACWY-CRM197.
Seroprotection is defined as a subject with a baseline hSBA titer < 1:4, seroresponse was defined as a post-vaccination hSBA titer ≥ 1:8; for a subject with a baseline hSBA titer ≥ 1:4, seroresponse was defined as a post-vaccination hSBA titer of at least 4 times the baseline."|Baseline and 1 month post last vaccination (day 57).|Analysis was done on the MITT data set.||Percentages of subjects||95% Confidence Interval|Number
846387|NCT01466387|Secondary|Percentages Of Subjects With Anti-JE Neutralizing Antibody Titers ≥ 1/10, 28 Days After The Vaccination Of The Last Doses Of Japanese Encephalitis And Rabies, Given Concomitantly With MenACWY-CRM197 Or Alone|"Immunogenicity was measured as the percentages of subjects who achieved seroprotection as measured by neutralization test for anti-Japanese encephalitis neutralizing antibody titers, 28 days after administration of the second dose of Japanese encephalitis virus vaccine and 28 days after the vaccination of third dose of rabies virus vaccine, given alone or concomitantly with MenACWY-CRM197.
Seroprotection is defined as percentages of subjects who achieved anti-JE neutralizing titers ≥ 1/10 on Day 57."|Baseline and 1 month post last vaccination (day 57).|The analysis was done on the MITT data set.||Percentages of subects||95% Confidence Interval|Number
846388|NCT01466387|Secondary|Percentages Of Subjects With Anti-YF Neutralizing Antibody Titers ≥ 1/10, 28 Days After The Vaccination Of Typhoid Vi Polysaccharide And Yellow Fever, Concomitantly With MenACWY-CRM197 Or Given Alone|"Immunogenicity was assessed as the percentages of subjects who achieved seroprotection as measured by neutralization test for anti-YF neutralizing antibody titers after the vaccination of typhoid Vi polysaccharide and yellow fever, given alone or concomitantly with MenACWY-CRM197 on day 29.
Seroprotection is defined as percentages of subjects who achieved anti-YF neutralizing antibody titers ≥ 1/10 on day 29."|Baseline and 1 month postvaccination (day 29).|Analysis was done on the Modified-Intention to Treat (MITT) set, i.e. the subjects who provided evaluable serum samples whose assay results are available for at least one antigen on baseline and on at least one post-baseline visit.||Percentages of subjects||95% Confidence Interval|Number
846389|NCT01466387|Primary|Geometric Mean Anti-Rabies Virus Neutralizing Antibody Concentration|Assessment was made to demonstrate the non-inferiority of the geometric mean anti-rabies virus neutralizing antibody concentrations, 28 days after the vaccination of the second dose of Japanese encephalitis vaccine and third dose of rabies virus vaccine given concomitantly with MenACWY-CRM197 or alone in healthy adults aged ≥18 years to ≤60 years.|Baseline and 1 month post last vaccination (day 57).|Analysis was done on the per-protocol (PP) set, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis.||IU/mL||95% Confidence Interval|Geometric Mean
846390|NCT01466387|Primary|Geometric Mean Anti-Japanese Encephalitis Neutralizing Antibody Titers|Assessment was made to demonstrate the non-inferiority of the geometric mean anti-Japanese encephalitis neutralizing antibody titers, 28 days after the vaccination of the second dose of Japanese Encephalitis vaccine and third dose of the rabies virus vaccine given concomitantly with MenACWY-CRM197 or alone in healthy adults aged ≥18 years to ≤60 years.|Baseline and 1 month post last vaccination (day 57).|Analysis was done on the PP set, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis.||Titers||95% Confidence Interval|Geometric Mean
846391|NCT01466387|Primary|Geometric Mean Anti-Yellow Fever Antibody Titer|Assessment was made to demonstrate the non-inferiority of the geometric mean anti-yellow fever antibody titers, 28 days after the vaccination of typhoid Vi polysaccharide (TF) and yellow fever (YF) vaccines given concomitantly with MenACWY-CRM197 to typhoid Vi polysaccharide and yellow fever vaccines given alone in healthy adults aged ≥18 years to ≤60 years.|Baseline and 1 month postvaccination (day 29).|Analysis was done on the per-protocol (PP) set, ie, the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis.||Titers||95% Confidence Interval|Geometric Mean
846392|NCT01466387|Primary|Geometric Mean Anti-typhoid Vi Antibody Concentrations|Assessment was made to demonstrate the non-inferiority of the geometric mean anti-typhoid Vi antibody concentrations, 28 days after the vaccination of typhoid Vi polysaccharide (TF) and yellow fever (YF) vaccines given concomitantly with MenACWY-CRM197 to typhoid Vi polysaccharide and yellow fever vaccines given alone in healthy adults aged ≥18 years to ≤60 years.|Baseline and 1 month postvaccination (day 29).|Analysis was done on the per-protocol (PP) set, ie, the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis.||El.U/mL||95% Confidence Interval|Geometric Mean
848368|NCT00073073|Secondary|Effect of This Drug on Bone Mineral Density||1 year|||percent change from baseline||95% Confidence Interval|Mean
846395|NCT01453348|Secondary|Percentages of Subjects With Seroresponse Against N Meningitidis A, C, W and Y Serogroups at Day 29|"Immunogenicity was assessed as the seroresponse rates for meningococcal serogroups A, C, W and Y elicited by MenACWY-CRM on day 29 when given concomitantly with combined hepatitis A/B vaccine or given alone.
For a subject with a baseline hSBA titer < 1:4, seroresponse is defined as a postvaccination hSBA titer ≥1:8; for a subject with a baseline hSBA titer ≥ 1:4, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline."|28 days postvaccination (day 29).|Analysis was done on modified intention-to-treat (MITT) population- subjects who provided evaluable serum samples whose assay results are available for at least one antigen on visit day 1 and a post baseline visit.||percentage of subjects||95% Confidence Interval|Number
846396|NCT01453348|Secondary|Percentages of Subjects With antiHAV and antiHBsAg Antibodies Concentrations Above Seroprotection Level 28 Days After Primary or Booster Vaccination|Immunogenicity was assessed as the percentages of subjects with anti-HAV concentration ≥20 mIU/mL and anti- HBsAg antibody concentration ≥10 mIU/mL, 28 days after primary or booster vaccination.|28 days post primary or booster vaccination.|Analysis was done on modified intention-to-treat (MITT) population- subjects who provided evaluable serum samples whose assay results are available for at least one antigen on visit day 1 and a post baseline visit.||percentage of subjects||95% Confidence Interval|Number
846397|NCT01453348|Primary|Geometric Mean antiHAV and antiHBV Concentrations (GMCs), 28 Days After Primary and Booster Vaccination|Assessment was made to demonstrate the non-inferiority of hepatitis A/B vaccine with MenACWY-CRM as compared to hepatitis A/B vaccine without MenACWY-CRM, as measured by geometric mean concentrations on day 57 in previously unvaccinated subjects or on day 29 after a booster dose in previously vaccinated subjects.|Day 57 (previously unprimed subjects) day 29 (previously primed subjects) postvaccination.|Analysis was done on Per Protocol (PP) population who provided evaluable serum samples and whose assay results were available at the relevant time points, and had no major protocol deviations||Concentrations (mIU/mL)||95% Confidence Interval|Geometric Mean
846398|NCT01439360|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Related = symptom assessed by the investigator as causally related to the study vaccination.|During the entire study period (approximately 6- 8 months per subject)|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.||Subjects|||Number
846399|NCT01439360|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Potential Immune-mediated Diseases (pIMDs).|pIMDs are a subset of adverse events (AEs) that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Grade 3 = pIMDs that prevented normal activities. Related = symptom assed by the investigator as causally related to the study vaccination.|During the entire study period (approximately 6- 8 months per subject)|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.||Subjects|||Number
846400|NCT01439360|Secondary|Number of Subjects Reporting Any, Grade 3 and Related AEs With Medically Attended Visits (MAVs)|MAVs were defined as AEs with a medically-attended visit i.e. prompting emergency room (ER) visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. Any MAV was defined as at least one MAV experienced. Grade 3 was defined as MAVs that prevented normal activities and related was defined as MAVs assessed by the investigator to be causally related to the study vaccination.|During the entire study period (approximately 6- 8 months per subject)|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.||Subjects|||Number
846401|NCT01439360|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.|During the 28-day (Days 0-27) post-vaccination period|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.||Subjects|||Number
846402|NCT01439360|Secondary|Duration of Solicited General Symptoms|Duration was defined as number of days with any grade of general symptoms.|During the 7-day (Days 0-6) post-vaccination period|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented. The analysis of solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e. symptom screen/sheet completed).||Days||Full Range|Median
846403|NCT01439360|Secondary|Duration of Solicited Local Symptoms|Duration was defined as number of days with any grade of local symptoms.|During the 7-day (Days 0-6) post-vaccination period|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented. The analysis of solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e. symptom screen/sheet completed).||Days||Full Range|Median
846404|NCT01439360|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed were Drowsiness, Irritability/fussiness, Loss of appetite and Temperature (Axillary). Any was defined as any general symptom reported irrespective of intensity or relationship to vaccination. Grade 3 was defined as symptoms that prevented normal activity. Related was defined as general symptom assessed by the investigator to have a causal relationship to vaccination.|During the 7-day (Days 0-6) post-vaccination period|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented. The analysis of solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e. symptom screen/sheet completed).||Subjects|||Number
846426|NCT01423253|Secondary|Mean Change From Baseline to Week 12 (LOCF) in MADRS Total Scores|Mean change from baseline to week 12 (LOCF) in Montgomery-Asberg Depression Rating Scale (MADRS) total scores The MADRS is a clinician-rated assessment of the subject’s level of depression and consists of 10 items. Each item is rated on a Likert scale, from 0=”Normal” to 6=”Most Severe”. The MADRS total score is calculated as the sum of the ten items and ranges from 0 to 60. Higher scores are associated with greater severity.|Baseline to12 Weeks|Safety population - only 47 subjects had the MADRS assessment at Week 12 (LOCF).||units on a scale||Standard Deviation|Mean
846405|NCT01439360|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that resulted crying when limb was moved/ spontaneously painful. Grade 3 redness and swelling was greater than 50 millimeters (mm) i.e. >50mm.|During the 7-day (Days 0-6) post-vaccination period|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented. The analysis of solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e. symptom screen/sheet completed).||Subjects|||Number
846406|NCT01439360|Secondary|Number of Seroprotected Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only)|"Seroprotection rate (SPR) was defined as the number of subjects with H1N1 reciprocal HI titers ≥ 1:40 against the tested vaccine virus.The vaccine strains assessed were A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Brisbane/3/2007 (Yamagata).
PRE= Pre-vaccination at Day 0; POST = Post-vaccination 1 at Day 28 for primed subjects or post-vaccination 2 at Day 56 for unprimed subjects"|At Day 0 and Day 28/56|The ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. These included subjects for whom assay results were available for antibodies against at least one study vaccine strain after vaccination.||Subjects|||Number
846407|NCT01439360|Secondary|Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only).|"MGI also known as the seroconversion factor [SCF] was defined as the fold increase in serum HI GMTs post vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Brisbane/3/2007 (Yamagata).
POST = Post-vaccination 1 at Day 28 for primed subjects or post-vaccination 2 at Day 56 for unprimed subjects."|At Day 28/56 (POST)|The ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. These included subjects for whom assay results were available for antibodies against at least one study vaccine strain after vaccination.||Fold increase||95% Confidence Interval|Geometric Mean
846408|NCT01439360|Secondary|Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only)|"Seroconversion rate (SCR) was defined as the number of subjects who have either a pre-vaccination reciprocal HI titer < 1:10 and a post-vaccination reciprocal titer ≥ 1:40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4 fold increase in post vaccination reciprocal titer against the vaccine virus.
PRE= Pre-vaccination at Day 0; POST = Post-vaccination 1 at Day 28 for primed subjects or post-vaccination 2 at Day 56 for unprimed subjects"|At Day 28/56 (POST)|The ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. These included subjects for whom assay results were available for antibodies against at least one study vaccine strain after vaccination.||Subjects|||Number
846409|NCT01439360|Secondary|Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only)|"A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10. The vaccine strains assessed were A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Brisbane/3/2007 (Yamagata).
PRE= Pre-vaccination at Day 0; POST = Post-vaccination 1 at Day 28 for primed subjects or post-vaccination 2 at Day 56 for unprimed subjects."|At Day 0 and Day 28/56|The ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. These included subjects for whom assay results were available for antibodies against at least one study vaccine strain after vaccination.||Subjects|||Number
846410|NCT01439360|Secondary|Humoral Immune Response in Terms of Haemagglutination-inhibition (HI) Antibody Titres Against Each of Four Vaccine Strains Contained in the D-QIV (in Immuno Subcohort of Subjects Only)|"Titers were expressed as geometric mean antibody titers (GMTs). The vaccine strains assessed were A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Brisbane/3/2007 (Yamagata).
PRE= Pre-vaccination at Day 0; POST = Post-vaccination 1 at Day 28 for primed subjects or post-vaccination 2 at Day 56 for unprimed subjects"|At Days 0 and 28/56|The ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. These included subjects for whom assay results were available for antibodies against at least one study vaccine strain after vaccination.||Titers||95% Confidence Interval|Geometric Mean
846411|NCT01439360|Secondary|Number of Subjects With First Occurrence of RT-PCR Confirmed Severe Influenza A and/or B Due to Any Seasonal Influenza Strain.|Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.|During the surveillance period (approximately 6 to 8 months)|The ATP cohort for efficacy – Time to event included all eligible subjects who received study vaccine(s) according to their random assignment, for whom vaccine administration site was known, who had a swab collected during the window (0-7 days) of episode onset and who would be censored but not eliminated based on protocol criteria.||Subjects|||Number
846412|NCT01439360|Secondary|Number of Subjects With First Occurrence of Acute Otitis Media (AOM) With RT-PCR Confirmed Influenza A and/or B Infection Due to Any Seasonal Influenza Strain.|Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.|At any time starting 7 days before the onset of LRI and ending 7 days after end of LRI during the surveillance period (approximately 6 to 8 months)|The ATP cohort for efficacy – Time to event included all eligible subjects who received study vaccine(s) according to their random assignment, for whom vaccine administration site was known, who had a swab collected during the window (0-7 days) of episode onset and who would be censored but not eliminated based on protocol criteria.||Subjects|||Number
846413|NCT01439360|Secondary|Number of Subjects With First Occurrence of Culture-confirmed Influenza A and/or B Disease of Any Severity Due to Any Seasonal Influenza Strain.|Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.|During the surveillance period (approximately 6 to 8 months)|The ATP cohort for efficacy – Time to event included all eligible subjects who received study vaccine(s) according to their random assignment, for whom vaccine administration site was known, who had a swab collected during the window (0-7 days) of episode onset and who would be censored but not eliminated based on protocol criteria.||Subjects|||Number
846414|NCT01439360|Secondary|Number of Subjects With First Occurrence of Culture-confirmed Moderate to Severe Influenza A and/or B Disease Due to Any Seasonal Influenza Strain.|Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.|During the surveillance period (approximately 6 to 8 months)|The ATP cohort for efficacy – Time to event included all eligible subjects who received study vaccine(s) according to their random assignment, for whom vaccine administration site was known, who had a swab collected during the window (0-7 days) of episode onset and who would be censored but not eliminated based on protocol criteria.||Subjects|||Number
846415|NCT01439360|Secondary|Number of Subjects With First Occurrence of Culture-confirmed Influenza A and/or B Disease of Any Severity Due to Antigenically-matching Influenza Strains|Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.|During the surveillance period (approximately 6 to 8 months)|The ATP cohort for efficacy – Time to event included all eligible subjects who received study vaccine(s) according to their random assignment, for whom vaccine administration site was known, who had a swab collected during the window (0-7 days) of episode onset and who would be censored but not eliminated based on protocol criteria.||Subjects|||Number
846416|NCT01439360|Secondary|Number of Subjects With First Occurrence of Culture-confirmed Moderate to Severe Influenza A and/or B Disease Due to Antigenically-matching Influenza Strains.|Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.|During the surveillance period (approximately 6 to 8 months)|The ATP cohort for efficacy – Time to event included all eligible subjects who received study vaccine(s) according to their random assignment, for whom vaccine administration site was known, who had a swab collected during the window (0-7 days) of episode onset and who would be censored but not eliminated based on protocol criteria.||Subjects|||Number
846417|NCT01439360|Secondary|Number of Subjects With First Occurrence of Lower Respiratory Illness (LRI) With RT-PCR Confirmed Influenza.|Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.|At any time starting 7 days before the onset of LRI and ending 7 days after end of LRI during the surveillance period (approximately 6 to 8 months)|The ATP cohort for efficacy – Time to event included all eligible subjects who received study vaccine(s) according to their random assignment, for whom vaccine administration site was known, who had a swab collected during the window (0-7 days) of episode onset and who would be censored but not eliminated based on protocol criteria.||Subjects|||Number
846418|NCT01439360|Primary|Number of Subjects With RT-PCR Confirmed Influenza of Any Severity.|Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.|During the surveillance period (approximately 6 to 8 months)|The ATP cohort for efficacy – Time to event included all eligible subjects who received study vaccine(s) according to their random assignment, for whom vaccine administration site was known, who had a swab collected during the window (0-7 days) of episode onset and who would be censored but not eliminated based on protocol criteria.||Subjects|||Number
846419|NCT01439360|Primary|Number of Subjects With Moderate to Severe RT-PCR Confirmed Influenza.|Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.|During the surveillance period (approximately 6 to 8 months)|The ATP cohort for efficacy – Time to event included all eligible subjects who received study vaccine(s) according to their random assignment, for whom vaccine administration site was known, who had a swab collected during the window (0-7 days) of episode onset and who would be censored but not eliminated based on protocol criteria.||Subjects|||Number
846420|NCT01423253|Secondary|Change From Baseline to Week 12 (LOCF) in the SDS Total Score|The Sheehan Disability Scale (SDS) is a composite of three self-rated items designed to measure the extent to which three major sectors (work/school, social life/leisure, and family life/home responsibility) in the patient’s life are impaired by depressive symptoms. These three items are responded to on a visual analogue scale (VAS) ranging through 0 (no impairment), 1–3 (mild), 4–6 (moderate), 7–9 (marked) and 10 (extreme) disability. The SDS total score is calculated as the sum of the three items and ranges from 0 (unimpaired) to 30 (highly impaired).|Baseline to week 12|Safety Population - 12 subjects did not have the SDS total score at week 12 (LOCF)||units on a scale||Standard Deviation|Mean
846421|NCT01423253|Secondary|Change From Baseline to Week 12 (LOCF) in the HAM-A Total Score|The Hamilton Rating Scale for Anxiety (HAM-A) is used to quantify the severity of anxiety symptomatology and consists of 14 items. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe/disabling). The HAM-A total score is calculated as the sum of the 14 individual items and ranges from 0 to 56. Higher scores are associated with greater degree of anxiety.|Baseline to week 12|Safety Population - 4 subjects did not have the HAM-A assessment at week 12 (LOCF)||units on a scale||Standard Deviation|Mean
846422|NCT01423253|Secondary|Change From Baseline to Week 12 (LOCF) in the YMRS Total Score|The Young Mania Rating Scale (YMRS) is an 11-item instrument used to assess the severity of mania. Seven items are rated on a 5-point scale, ranging from 0 to 4, and four items are rated on a 9-point scale, ranging from 0 to 8. The YMRS total score is calculated as the sum of the 11 items and ranges from 0 to 60. Higher scores are associated with greater severity of mania.|Baseline to week 12|Safety population - 2 subject did not have YMRS assessment at week 12 (LOCF)||units on a scale||Standard Deviation|Mean
846423|NCT01423253|Secondary|Change From Baseline to Week 12 (LOCF) in CGI-S Score|The Clinical Global Impression - Severity of illness (CGI-S) score is a single value, clinician-rated assessment of illness severity and ranges from 1= ‘Normal, not at all ill’ to 7= ‘Among the most extremely ill patients’. A higher score is associated with greater illness severity.|baseline to week 12|Safety population - 1 subject did not have the CGI-S assessment at week 12 (LOCF)||units on a scale||Standard Deviation|Mean
846424|NCT01423253|Primary|Percentage of Subjects Who Discontinued Due to Treatment Emergent Adverse Events (TEAEs)|Percentage of subjects who discontinued due to Treatment Emergent Adverse Events (TEAEs)|12 Weeks|Safety Population||percentage of subjects|||Number
846425|NCT01423253|Primary|Percentage of Subjects With Treatment Emergent Serious Adverse Events (TESAEs)|Percentage of subjects with Treatment Emergent Serious Adverse Events (TESAEs)|12 Weeks|Safety Population||percentage of subjects|||Number
846427|NCT01423253|Primary|Percentage of Subjects With Treatment Emergent Adverse Events (TEAEs)|Percentage of subjects with treatment emergent adverse events (TEAEs)|12 Weeks|Safety population||percentage of subjects|||Number
848369|NCT00073073|Primary|Percent Change in Mammographic Density at 1 Year on Exemestane||1 year|||percent change from baseline||95% Confidence Interval|Mean
846428|NCT01422408|Secondary|Change in Vaginal Itching Symptom Scores by Tube Weight Based Compliance Characteristics|"Association of response in symptoms with tube weight based compliance (Itching)
Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with compliance determined by % of tube used by weight.
Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
Groups are made by % of tube used by weight."|Baseline and 4 weeks|The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.||units on a scale||Inter-Quartile Range|Median
846429|NCT01422408|Secondary|Change in Dyspareunia Symptom Scores by Tube Weight Based Compliance Characteristics|"Association of response in symptoms with tube weight based compliance (Dyspareunia)
Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with compliance determined by % of tube used by weight.
Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
Groups are made by % of tube used by weight."|Baseline and 4 weeks|The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.||units on a scale||Inter-Quartile Range|Median
846430|NCT01422408|Secondary|Change in Vaginal Dryness Symptom Scores by Tube Weight Based Compliance Characteristics|"Association of response in symptoms with tube weight based compliance (Dryness)
Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with compliance determined by % of tube used by weight.
Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
Groups are made by % of tube used by weight."|Baseline and 4 weeks|The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.||units on a scale||Inter-Quartile Range|Median
846431|NCT01422408|Secondary|Change in Vaginal Itching Symptom Scores by Patient Reported Compliance Characteristics|"Association of response in symptoms with patient reported compliance (Itching)
Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with patient reported compliance.
Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
Groups are made by % of compliance reported by patients"|Baseline and 4 weeks|The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.||units on a scale||Inter-Quartile Range|Median
846432|NCT01422408|Secondary|Change in Dyspareunia Symptom Scores by Patient Reported Compliance Characteristics|"Association of response in symptoms with patient reported compliance (Dyspareunia)
Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with patient reported compliance.
Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
Groups are made by % of compliance reported by patients"|Baseline and 4 weeks|The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.||units on a scale||Inter-Quartile Range|Median
846433|NCT01422408|Secondary|Change in Vaginal Dryness Symptom Scores by Patient Reported Compliance Characteristics|"Association of response in symptoms with patient reported compliance (Dryness)
Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with patient reported compliance.
Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
Groups are made by % of compliance reported by patients"|Baseline and 4 weeks|The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.||units on a scale||Inter-Quartile Range|Median
846454|NCT01411852|Secondary|In-hospital Mortality|Number of patients who died prior to discharge.|From day of the 911 call through hospital discharge|All enrolled patients||participants|||Number
846434|NCT01422408|Secondary|Change in Vaginal Itching Symptom Scores by Indication for Endocrine Therapy Characteristics|"Association of response in symptoms with characteristics of the subject population (Itching and Indications)
Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.
Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms."|Baseline and 4 weeks|The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.||units on a scale||Inter-Quartile Range|Median
846435|NCT01422408|Secondary|Change in Dyspareunia Symptom Scores by Indication for Endocrine Therapy Characteristics|"Association of response in symptoms with characteristics of the subject population (Dyspareunia and Indications)
Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.
Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms."|Baseline and 4 weeks|The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.||units on a scale||Inter-Quartile Range|Median
846436|NCT01422408|Secondary|Change in Vaginal Dryness Symptom Scores by Indication for Endocrine Therapy Characteristics|"Association of response in symptoms with characteristics of the subject population (Dryness and Indications)
Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.
Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms."|Baseline and 4 weeks|The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.||units on a scale||Inter-Quartile Range|Median
846437|NCT01422408|Secondary|Change in Vaginal Itching Symptom Scores by Prior Cytotoxic Therapy Characteristics|"Association of response in symptoms with characteristics of the subject population (Itching and prior cytotoxic therapy)
Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.
Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms."|Baseline and 4 weeks|The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.||units on a scale||Inter-Quartile Range|Median
846438|NCT01422408|Secondary|Change in Dyspareunia Symptom Scores by Prior Cytotoxic Therapy Characteristics|"Association of response in symptoms with characteristics of the subject population (Dyspareunia and prior cytotoxic therapy)
Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.
Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms."|Baseline and 4 weeks|The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.||units on a scale||Inter-Quartile Range|Median
846439|NCT01422408|Secondary|Change in Vaginal Dryness Symptom Scores by Prior Cytotoxic Therapy Characteristics|"Association of response in symptoms with characteristics of the subject population (Dryness and prior cytotoxic therapy)
Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.
Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms."|Baseline and 4 weeks|The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.||units on a scale||Inter-Quartile Range|Median
846455|NCT01411852|Secondary|Penetrating Trauma 24 Hour Mortality|The 24 hour mortality endpoint for the total number of patients injured by penetrating mechanisms in each arm.|From time of hospital arrival through first 24 hours|Patients with traumatic shock due to penetrating traumatic mechanisms||participants|||Number
846440|NCT01422408|Secondary|Change in Vaginal Itching Symptom Scores by Current Endocrine Therapy Characteristics|"Association of response in symptoms with characteristics of the subject population (Itching and current endocrine therapy)
Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.
Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms."|Baseline and 4 weeks|The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.||units on a scale||Inter-Quartile Range|Median
846441|NCT01422408|Secondary|Change in Dyspareunia Symptom Scores by Current Endocrine Therapy Characteristics|"Association of response in symptoms with characteristics of the subject population (Dyspareunia and current endocrine therapy)
Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.
Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms."|Baseline and 4 weeks|The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.||units on a scale||Inter-Quartile Range|Median
846442|NCT01422408|Secondary|Change in Vaginal Dryness Symptom Scores by Current Endocrine Therapy Characteristics|"Association of response in symptoms with characteristics of the subject population (Dryness and current endocrine therapy)
Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.
Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms."|Baseline and 4 weeks|The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.||units on a scale||Inter-Quartile Range|Median
846443|NCT01422408|Secondary|Change in Vaginal Itching Symptom Scores by Menopause Status Characteristics|"Association of response in symptoms with characteristics of the subject population (Itching and Menopause status)
Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.
Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms."|Baseline and 4 weeks|The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.||units on a scale||Inter-Quartile Range|Median
846444|NCT01422408|Secondary|Change in Dyspareunia Symptom Scores by Menopause Status Characteristics|"Association of response in symptoms with characteristics of the subject population (Dyspareunia and Menopause status)
Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.
Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms."|Baseline and 4 weeks|The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.||units on a scale||Inter-Quartile Range|Median
846445|NCT01422408|Secondary|Change in Vaginal Dryness Symptom Scores by Menopause Status Characteristics|"Association of response in symptoms with characteristics of the subject population (Dryness and Menopause status)
Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.
Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms."|Baseline and 4 weeks|The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.||units on a scale||Inter-Quartile Range|Median
846486|NCT01369342|Secondary|Number of Participants in Clinical Remission at Week 8|Clinical remission at Week 8 was defined as a Crohn’s Disease Activity Index (CDAI) score of <150 points.|Week 8|Efficacy analyses set included all the participants who were randomized after the study was restarted.||participants|||Number
846446|NCT01422408|Secondary|Change in Vaginal Itching Symptom Scores by Age Characteristics|"Association of response in symptoms with characteristics of the subject population (Itching and Age)
Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.
Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms."|Baseline and 4 weeks|The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.||units on a scale||Inter-Quartile Range|Median
846447|NCT01422408|Secondary|Change in Dyspareunia Symptom Scores by Age Characteristics|"Association of response in symptoms with characteristics of the subject population (Dyspareunia and Age)
Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.
Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms."|Baseline and 4 weeks|The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.||units on a scale||Inter-Quartile Range|Median
846448|NCT01422408|Secondary|Change in Vaginal Dryness Symptom Scores by Age Characteristics|"Association of response in symptoms with characteristics of the subject population (Dryness and Age)
Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.
Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms."|Baseline and 4 weeks|The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.||units on a scale||Inter-Quartile Range|Median
846449|NCT01422408|Secondary|Number of Patients Experiencing Toxicities|Toxicity data will be reported as descriptive data as the percentage of patients experiencing reported side effects. Toxicity and safety analyses will be conducted using the safety analysis set.|Over 4 weeks|Toxicity and safety analyses will be conducted using the safety analysis set.||Participants|||Count of Participants
846450|NCT01422408|Secondary|Change in Total Vaginal Index Score.|"Change in total vaginal index score. The total vaginal index score is a numerical value ranging from zero to twelve, comprised of the three components of vaginal dryness, vaginal itching, and dyspareunia graded on an ordinal scale of zero to four added together.
Outcome measures median change in score from baseline to end of study. Scale is explained above for the scoring of symptoms at each time point. The median change (i.e. median difference) can range from -12 to +12; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
Analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-secondary endpoints."|Baseline and 4 weeks|||units on a scale||Inter-Quartile Range|Median
846451|NCT01422408|Secondary|Change in Symptom Scores of Vaginal Itching|"Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively). Analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-secondary endpoints.
Outcome measures median change in score from baseline to end of study. Scale is explained above for the scoring of symptoms at each time point. The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms."|Baseline and 4 weeks|||units on a scale||Inter-Quartile Range|Median
846452|NCT01422408|Primary|Change in Symptom Scores of Dyspareunia|"Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively). Analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-primary endpoints.
Outcome measures median change in score from baseline to end of study. Scale is explained above for the scoring of symptoms at each time point. The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms."|Baseline and 4 weeks|||units on a scale||Inter-Quartile Range|Median
846453|NCT01422408|Primary|Change in Symptom Scores of Vaginal Dryness|"Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively). Analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-primary endpoints.
Outcome measures median change in score from baseline to end of study. Scale is explained above for the scoring of symptoms at each time point. The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms."|Baseline and 4 weeks|||units on a scale||Inter-Quartile Range|Median
846456|NCT01411852|Secondary|Blunt Trauma 24 Hour Mortality|The 24 hour mortality endpoint for the total number of patients injured by blunt mechanisms in each arm.|From time of hospital arrival through first 24 hours|Analyzed patients had traumatic shock due to blunt traumatic mechanisms. One patient randomized to the controlled resuscitation group was not analyzed because neither blunt force nor penetrating injury had occurred. It was determined that the source of bleeding was from a gastrointestinal lesion.||participants|||Number
846457|NCT01411852|Secondary|Days Alive Out of the Hospital Through Day 28|"The number of days beginning with the day of the 911 call counted as Day 0 through Day 28 during which the patient is alive and not being cared for in the hospital"|From day of the 911 call through Day 28|Patients with known discharge status||Days alive out of hospital thru day 28||Standard Deviation|Mean
846458|NCT01411852|Secondary|Days Alive Out of the Intensive Care Unit (ICU) Through Day 28|"The number of days beginning with the day of the 911 call counted as Day 0 through Day 28 during which the patient is alive and not being cared for in the intensive care unit"|From day of the 911 call through Day 28|Patients with known discharge status||ICU-free days||Standard Deviation|Mean
846459|NCT01411852|Secondary|Ventilator Free Days Through Day 28|"The number of days beginning with the day of the 911 call counted as Day 0 through Day 28 during which the patient did not require mechanical ventilation. Deaths are assigned the worst score (0)."|From day of the 911 call through Day 28|Patients with known discharge status.||Ventilator-free days||Standard Deviation|Mean
846460|NCT01411852|Secondary|"Acute Renal Failure Classification Score of Failure Without Glomerular Filtration Rate (GFR)"|Increased plasma creatinine > 3 x reference measure (ED admission) or acute plasma creatinine = 350 umol/L or acute rise = 44 umol/L or urine output < 0.3 mL/k/h x 24h. Only measured for patients with at least 2 days of ICU stay assessed.|From ED arrival through the first 24 hours|Patients with at least at 2 day stay in the ICU||participants|||Number
846461|NCT01411852|Secondary|"Acute Renal Failure Classification Score of Injury Without Glomerular Filtration Rate (GFR)"|"Increased plasma creatinine > 2 x reference measure (ED admission) or urine output < 0.5 mL/kg/h x 24h. The RIFLE urine criterion for this level actually specifies a 12 hour period of assessment but study data are collected for 24-hr periods. This row includes patients who met the Failure criteria as well. Only measured for patients with at least 2 days of ICU stay assessed."|From ED arrival through Day 28|Patients with at least at 2 day stay in the ICU||participants|||Number
846462|NCT01411852|Secondary|"Acute Renal Failure Classification Score of Risk Without Glomerular Filtration Rate (GFR)"|"Increased plasma creatinine > 1.5 x reference measure (ED admission). Urine criteria is based on 6-hour periods for this level of the RIFLE and cannot be assessed since study data are collected for 24-hour periods. This row includes patients who met the Injury and Failure criteria as well. Only measured for patients with at least 2 days of ICU stay assessed."|From ED arrival through Day 28|Patients with at least a 2 day ICU stay||participants|||Number
846463|NCT01411852|Secondary|Hemorrhage Control Procedure Within 2 Hours of ED Arrival|Hemorrhage control procedures include blood vessel ligated or embolized, organ packed or removed, laparotomy or thoracotomy|From ED arrival through the first 2 hours|All patients except for 1 patient who was enrolled while in police custody||participants|||Number
846464|NCT01411852|Secondary|International Normalized Ratio (INR) on Admission to the Emergency Department|The first International normalized ratio (INR) value reported from blood drawn within the first 24 hours from arrival|From final Emergency Department arrival time through first 24 hours|Patients who had a first INR value measured within the first 24 hours of ED arrival||ratio||Standard Deviation|Mean
846465|NCT01411852|Secondary|Platelet Value on Admission|First platelet value from blood drawn in the the first 24 hours after arrival|From final Emergency Department arrival time through first 24 hours|All patients with the first platelet value measured within the first 24 hours of ED arrival||10^9 Platelets/Liters||Standard Deviation|Mean
846466|NCT01411852|Secondary|Hemoglobin on Admission to the Emergency Department|The first hemoglobin value reported from blood drawn in the final Emergency Department|From final Emergency Department arrival time through first 24 hours|All patients with a first hemoglobin measured within the first 24 hours of ED arrival||grams/deciliter||Standard Deviation|Mean
846467|NCT01411852|Secondary|Base Deficit on Admission to the Emergency Department (ED)|The first base deficit value reported from arterial blood lab work drawn after arrival in the final Emergency Department. This measure reflects the acid-base balance in the arterial blood. A negative number indicates that the blood is more acid that normal.|From final Emergency Department arrival time through first 24 hours|Patient with the first base deficit recorded in the first 24 hours of the ED arrival||mmol/Liter||Standard Deviation|Mean
846468|NCT01411852|Secondary|Total Blood Product Requirements in First 24 Hours|Total amount of blood products required: packed red blood cells (PRBC), fresh frozen plasma (FFP), platelets (plts), cryoprecipitate (cryo)|From ED arrival through the first 24 hours|All patients except one who was enrolled while in police custody||Liters||Standard Deviation|Mean
846469|NCT01411852|Secondary|Total Fluid Requirement During First 24 Hours|Total volume of fluid administered during the first 24 hours inclusive of crystalloids, blood products, 3% saline, mannitol, and other colloids|From ED arrival through the first 24 hours|All patients except one who was enrolled while in police custody||Liters||Standard Deviation|Mean
846470|NCT01411852|Secondary|Number of Ineligible Patients Enrolled at the Time of Randomization|"Eligibility criteria:
Inclusion Criteria
Included will be those with:
Blunt or penetrating injury
Age ≥15yrs or weight ≥50kg if age is unknown
Prehospital SBP ≤ 90 mmHg 5.3 Exclusion Criteria
Excluded will be those with:
Ground level falls
Evidence of severe blunt or penetrating head injury with a Glasgow Coma Score (GCS) ≤ 8
Bilateral paralysis secondary to suspected spinal cord injury
Fluid greater than 250 ml was given prior to randomization
Cardiopulmonary resuscitation (CPR) by Emergency Medical Services (EMS) prior to randomization
Known prisoners
Known or suspected pregnancy
Drowning or asphyxia due to hanging
Burns Total Body Surface Area (TBSA) > 20%
Time of call received at dispatch to study intervention > 4 hours"|From the time the paramedic with study drug kit arrived at patient's side to the time kit was opened prior to ED arrival|All patients enrolled in the study.||participants|||Number
846471|NCT01411852|Primary|24 Hour Mortality|The 24 hour mortality endpoint for the total number of patients each arm|From time of hospital arrival through the first 24 hours|All patients except for one who was enrolled while in police custody||participants|||Number
846472|NCT01411852|Primary|Total Volume of All Crystalloid Given for Early Resuscitation (Feasibility)|The primary feasibility endpoint was early crystalloid volume (ECV) defined as crystalloid infused from Emergency Medical Services (EMS) arrival at the scene until the end of the study period|From time of first intravenous or intraosseous insertion through the first 2 hours after hospital arrival or hemorrhage control, which ever occurs first|Patients with traumatic shock due to blunt or penetrating mechanisms||liters||95% Confidence Interval|Mean
846473|NCT01409096|Secondary|Hamilton Rating Scale for Anxiety (HRSA)|"The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety).
Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0–56, where less than 17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe."|12 weeks|||units on a scale||Standard Error|Least Squares Mean
846474|NCT01409096|Secondary|Young Mania Rating Scale (YMRS)|"This is an 11-item, observer rated measure of the severity of manic symptoms on a 5 point scale. The total score indicates overall severity of mania with a minimum of zero (indicating normalcy) and a maximum of 60 (indicating very severe).
Score:
Minimum: 0 Maximum: 60 Lower score associated with better outcome"|12 weeks|||units on a scale||Standard Error|Least Squares Mean
846475|NCT01409096|Secondary|Inventory of Depressive Symptomatology-Self Report (IDS-SR)|"IDS-SR is a self reported 30 item assessment to diagnose a major depressive episode.
Score:
Minimum: 0 Maximum: 84 Lower score associated with better outcome"|12 weeks|||units on a scale||Standard Error|Least Squares Mean
846476|NCT01409096|Primary|The 17-item Hamilton Rating Scale for Depression (HRSD17)|"The HRSD is an observer-rated measure of depressive symptomatology.
Minimum: 0; Maximum: 50; Better outcome: lower score; Normal score: 7 or less."|12 weeks|||units on a scale||Standard Error|Least Squares Mean
846477|NCT01406223|Secondary|Days to First Cigarette Following Quitting Smoking|Days to first cigarette (i.e. lapse) will be measured via self-report.|11 weeks post quit day.|Twenty-eight subjects dropped from the study prior to their scheduled quit day, so they were not included in these analyses.||days||Standard Deviation|Mean
846478|NCT01406223|Primary|The Amygdala, Anterior Insula, and Medial Prefrontal Cortex Scans Will be Compared to Evaluate Significant Differences|Mean blood-oxygen-level dependent (BOLD) contrast sensitive functional magnetic resonance imaging (fMRI) cue-reactivity signal following 2 week pre-quit treatment, controlling for baseline cue-reactivity.|change from baseline in whole brain blood-oxygen-level dependent (BOLD) contrast sensitive functional magnetic resonance imaging (fMRI) images collected during a cue-reactivity task following 2 weeks of pre-quit treatment|Only participants who completed both scanning sessions and provided useable data were included in imaging analysis.||percent BOLD signal change||Standard Deviation|Mean
846479|NCT01375374|Secondary|Change in Total Cholesterol Level From Baseline to Treatment Period End (Comprised of a 4-week Titration Period and an 8-week Maintenance Period)|The change in total cholesterol levels from Baseline to the end of the Maintenance Period was summarized descriptively by visit. A negative value indicates an improvement.|From Day 1 (Baseline) to Day 84 (Treatment Period End)|The Analysis Population refers to the Safety Set (SS). The SS consists of all subjects who received at least 1 dose of Lacosamide.||mmol/L||Full Range|Median
846480|NCT01375374|Secondary|Change in Serum Thyroid Hormone Free Thyroxine Level From Baseline to Treatment Period End (Comprised of a 4-week Titration Period and an 8-week Maintenance Period)|The change in the serum thyroid hormone free thyroxine level from Baseline to the end of the Maintenance Period was summarized descriptively by visit.|From Day 1 (Baseline) to Day 84 (Treatment Period End)|The Analysis Population refers to the Safety Set (SS). The SS consists of all subjects who received at least 1 dose of Lacosamide.||pmol/L||Full Range|Median
846481|NCT01375374|Secondary|Change in Sex Hormone Calculated Free Androgen Index Levels From Baseline to Treatment Period End (Comprised of a 4-week Titration Period and an 8-week Maintenance Period)|The change in sex hormone calculated free androgen index (100 x Testosterone/sex hormone binding globulin) levels from Baseline to the end of Maintenance Period was summarized descriptively by visit. A negative value indicates an improvement.|From Day 1 (Baseline) to Day 84 (Treatment Period End)|The Analysis Population refers to the Safety Set (SS). The SS consists of all subjects who received at least 1 dose of Lacosamide.||Free Androgen Index||Full Range|Median
846482|NCT01375374|Primary|Change in Serum Sex Hormone Binding Globulin (SHBG) From Baseline to Treatment Period End (Comprised of a 4-week Titration Period and an 8-week Maintenance Period)|Due to premature termination of enrollment prior to achieving the planned sample size (a total of 28 subjects), this primary safety variable was assessed for descriptive purposes only. A negative value indicates an improvement.|From Day 1 (Baseline) to Day 84 (Treatment Period End)|The Analysis Population refers to the Safety Set (SS). The SS consists of all subjects who received at least 1 dose of Lacosamide.||nmol/L||Full Range|Median
846483|NCT01369342|Secondary|Number of Participants With CDAI 70 Point Response at Week 3|70-point response is defined as at least 70 points reduction in CDAI score (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 3|Efficacy analyses set included all the participants who were randomized after the study was restarted.||participants|||Number
846484|NCT01369342|Secondary|Number of Participants With Crohn's Disease Activity Index (CDAI) 70 Point Response at Week 6|70-point response is defined as at least 70 points reduction in CDAI score (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 6|Efficacy analyses set included all the participants who were randomized after the study was restarted.||participants|||Number
846485|NCT01369342|Secondary|Number of Participants in Clinical Response at Week 8|Clinical response at Week 8 was defined as a reduction from baseline in the CDAI score of greater than or equal (>=) 100 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). Participants with a baseline CDAI score of > = 220 to less than or equal (< =) 248 were considered to be in clinical response if a CDAI score of less than (<) 150 was attained. A decrease in CDAI score over time indicates improvement in disease activity.|Week 8|Efficacy analyses set included all the participants who were randomized after the study was restarted.||participants|||Number
846487|NCT01369342|Primary|Number of Participants With Clinical Response at Week 6|Clinical response at Week 6 was defined as a reduction from baseline in the Crohn's Disease Activity Index (CDAI) score of greater than or equal (>=) 100 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). Participants with a baseline CDAI score of > = 220 to less than or equal (< =) 248 were considered to be in clinical response if a CDAI score of less than (<) 150 was attained. A decrease in CDAI score over time indicates improvement in disease activity.|Week 6|Efficacy analyses set included all the participants who were randomized after the study was restarted.||participants|||Number
846488|NCT01369329|Secondary|Number of Participants With CDAI 70-point Response at Week 3|70-point response is defined as at least 70 points reduction in CDAI score. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline and Week 3|Efficacy analyses set included all the participants who were randomized after the study was restarted.||participants|||Number
846489|NCT01369329|Secondary|Number of Participants With Crohn's Disease Activity Index (CDAI) 70-point Response at Week 6|70-point response is defined as at least 70 points reduction in CDAI score. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline and Week 6|Efficacy analyses set included all the participants who were randomized after the study was restarted.||participants|||Number
846490|NCT01369329|Secondary|Number of Participants in Clinical Response at Week 8|Clinical response at Week 8 was defined as a reduction from baseline in the Crohn's Disease Activity Index (CDAI) score of greater than or equal (>=) 100 points. Participants with a baseline CDAI score of > = 220 to less than or equal (< =) 248 were considered to be in clinical response if a CDAI score of less than (<) 150 was attained. A CDAI score of less than 150 indicates clinical remission. A decrease in CDAI score over time indicates improvement in disease activity.|Baseline and Week 8|Efficacy analyses set included all the participants who were randomized after the study was restarted.||participants|||Number
846491|NCT01369329|Secondary|Number of Participants in Clinical Remission at Week 8|Clinical remission is defined as a CDAI score of less than (<) 150 points at Week 8.|Baseline and Week 8|Efficacy analyses set included all the participants who were randomized after the study was restarted.||participants|||Number
846492|NCT01369329|Primary|Number of Participants With Clinical Response at Week 6|Clinical response at Week 6 was defined as a reduction from baseline in the Crohn's Disease Activity Index score of greater than or equal (>=) 100 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). Participants with a baseline CDAI score of > = 220 to less than or equal (< =) 248 were considered to be in clinical response if a CDAI score of less than (<) 150 was attained. A CDAI score of less than 150 indicates clinical remission. A decrease in CDAI score over time indicates improvement in disease activity.|Baseline and Week 6|Efficacy analyses set included all the participants who were randomized after the study was restarted.||participants|||Number
846493|NCT01363479|Secondary|Proportion of Patients With no Rescue Medication||0-24 hours||||||
846494|NCT01363479|Secondary|Proportion of Patients With no Emesis||0-24 hours||||||
846495|NCT01363479|Primary|Proportion of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication||0-24 hours|Full Analysis Set i.e. patients receiving study drugs and chemotherapy||percentage of responders||95% Confidence Interval|Number
846496|NCT01362140|Secondary|Percentage of Participants With a Clinically Meaningful Improvement in Fatigue|"The FACIT-Fatigue scale was a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue.
Clinically meaningful improvement in fatigue is defined as an increase of ≥ 3 points in the FACIT-Fatigue subscale score, from baseline to EOTP."|Baseline to week 24|FACIT-fatigue analysis set||percentage of participants||95% Confidence Interval|Number
846497|NCT01362140|Secondary|Change From Baseline in EuroQol-5D (EQ-5D) Visual Analog Scale (VAS)|"The EQ-5D visual analog scale (VAS) is a global evaluation of overall health state with scores ranging from 0 (worse health state a participant can imagine) to 100 (best health state a participant can imagine).
End of treatment period (EOTP) analysis includes last available values."|Baseline, and weeks 13 and 25|The EQ-5D visual analog analysis set includes all participants in the primary analysis set who completed both the baseline and at least 1 subsequent visual analog scale.||units on a scale||Standard Deviation|Mean
846498|NCT01362140|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F)|"The FACIT-Fatigue scale was a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue.
A positive change from baseline score indicates an improvement. End of treatment period (EOTP) analysis includes last available values."|Baseline, and weeks 13 and 25|FACIT-Fatigue Analysis Set, includes all participants in the primary analysis set who completed or partially completed both the baseline and at least 1 subsequent FACIT-F questionnaire.||units on a scale||Standard Deviation|Mean
846499|NCT01362140|Secondary|Number of Participants Who Developed Neutralizing Antibodies to Darbepoetin Alfa|"Two validated assays were used to detect the presence of anti-darbepoetin alfa antibodies.
Samples were first tested in an immunoassay to detect antibodies capable of binding to darbepoetin alfa. Samples confirmed to be positive for binding antibodies were subsequently tested in a cell-based assay to determine neutralizing activity against darbepoetin alfa. If a sample was positive for binding antibodies and demonstrated neutralizing activity at the same time point, the sample was defined as positive for neutralizing antibodies.
The number of participants who developed antibodies to darbepoetin alfa is defined as participants who were neutralizing antibody positive post-baseline with a negative or no result at baseline."|Baseline and end of double-blind treatment period (24 weeks)|Safety analysis set participants with post-baseline antibody results||participants|||Number
846500|NCT01362140|Secondary|Number of Participants With Malignancies Other Than AML, Basal Cell Carcinoma, or Squamous Cell Carcinoma of the Skin||Up to 24 weeks|Safety analysis set||participants|||Number
847233|NCT00734539|Secondary|Neurodevelopmental Impairment|Bayley-III cognition composite score of less than 70, blindness, deafness, or cerebral palsy|18-22 months corrected gestational age|Attended the follow-up visit and had complete data on composite endpoint||participants|||Number
846501|NCT01362140|Secondary|Number of Participants With Disease Progression to Acute Myeloid Leukemia (AML)|Transformation to AML was assessed according to WHO guidelines in the absence of IP and any haematopoietic growth factors (2 weeks off dosing). Bone marrow and/or cytogenetic report confirmation of AML was required (marrow or peripheral blast cells ≥ 20%, presence of pathognomic AML cytogenetic change, or evidence of marrow blast criteria for erythroleukemia). A pathology report confirming other leukemias such as chloroma (granulocytic sarcoma, myeloid sarcoma) or leukemia cutis also constituted transformation to AML.|24 weeks|Safety analysis set with available data||participants|||Number
846502|NCT01362140|Secondary|Number of Participants With Adverse Events|"The severity of each adverse event was graded using the the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 grading scale, where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life-threatening and grade 5 = death.
Prespecified adverse events of interest for darbepoetin alfa, based on clinical data in anemic patients with cancer, included the following categories: hypersensitivity, cardiac failure, hypertension, malignancies, embolic and thrombolic events, venous thromboembolic events (VTEs), central nervous system vascular disorders, and ischemic heart disease."|From first dose of study drug until the end of the double-blind treatment period; 24 weeks.|Safety Analysis Set, including all participants who received at least 1 dose of study drug. One participant in the placebo arm inadvertently received a dose of darbepoetin alfa and is counted in the darbepoetin alfa group for safety analyses.||participants|||Number
846503|NCT01362140|Secondary|Percentage of Participants Who Achieved an Erythroid Response Based on International Working Group (IWG) 2006 Criteria in the Double-blind Treatment Period|"International Working Group 2006 erythroid response was defined as achieving an initial ≥ 1.5 g/dL increase in hemoglobin from baseline and sustaining an average rise of ≥ 1.5 g/dL in a rolling 56-consecutive day period in the absence of RBC transfusion.
Participants with no hemoglobin collected to the minimum time required to observe an IWG erythroid response (Week 13) were considered non-responders."|Up to 24 weeks|Primary analysis set participants with a central laboratory baseline hemoglobin value||percentage of participants||95% Confidence Interval|Number
846504|NCT01362140|Primary|Percentage of Participants With at Least One Red Blood Cell (RBC) Transfusion During the Double-blind Treatment Period||Week 5 to Week 25|Transfusion Primary Analysis Set which includes all randomized and consented participants who received at least 1 dose of study drug and who had an end of treatment period (EOTP) visit ≥ day 29 (ie, start of week 5).||percentage of participants|||Number
846505|NCT01354431|Secondary|Median Progression Free Survival (PFS) in Months at Interim Data Cut-off - Randomized Population|PFS: the time from randomization to the date of first disease progression (either clinical or radiographic progression, as assessed by the investigator) was measured in Months. Tumor assessments (radiographic scans) were done every 6 weeks from randomization for the first 12 months, then every 12 weeks until progression. PFS was calculated based on investigator's assessment of first date of progression (either clinical or radiographic progression) or date of death if progression did not occur. Participants were censored if they had not experienced disease progression (they were still on treatment or in follow-up) or had received subsequent cancer therapy. Disease Progression was at least a 20% increase in the sum of diameters of the longest target lesions since screening (the sum must be an absolute increase of at least 5 mm), or measurable increase in non-target lesion or appearance of one or more new lesions.|From Randomization to approximately 4 years post randomization|All Randomized participants were summarized up to March 2015 data cut off. Study on-going.||Months||80% Confidence Interval|Median
846506|NCT01354431|Secondary|Median Overall Survival in Months at Interim Data Cut-off - Randomized Population|Median Overall Survival (OS), measured in months, was based on Kaplan Meier estimates.|From Randomization to approximately 4 years post randomization|All Randomized participants were summarized up to interim data cut off, March 2015. Study on-going.||Months||80% Confidence Interval|Median
846507|NCT01354431|Secondary|Number of Participants With Best Overall Response at Primary Endpoint - Randomized Population|Best response defined as the best response across all time points. Primary endpoint=116 events, approximately 2 years. Tumor response was evaluated by investigator according to RECIST version 1.1. Complete Response (CR): disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm; partial response (PR): at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; Disease Progression (PD) was at least a 20% increase in the sum of diameters of the longest target lesions since screening (the sum must be an absolute increase of at least 5 mm), or measurable increase in non-target lesion or appearance of one or more new lesions; Stable disease: neither shrinkage to qualify for PR or increase to qualify for PD.|From randomization until after approximately 116 events (disease progression or death), approximately 2 years.|All Randomized participants were summarized up to Primary endpoint data cut off, approximately 2 years.||participants|||Number
846508|NCT01354431|Secondary|Objective Response Rate (ORR) at Primary Endpoint- Randomized Population|Tumor response was evaluated by investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Objective response rate (ORR) was defined as the number of responders divided by the number of randomized participants; Responders=complete response (CR) or partial response (PR). CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm; PR: at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR was estimated along with exact 80% Confidence Interval (CI) using the Clopper and Pearson method.|From randomization until after approximately 116 events (disease progression or death), approximately 2 years.|All randomized participants were analyzed up to Primary endpoint, approximately 2 years.||percentage of participants||80% Confidence Interval|Number
846521|NCT01340300|Secondary|Changes in Other Insulin-Related Biomarkers|Markers related to insulin and insulin-like growth factors (including insulin-like growth factor 1 [IGF-1], IGF binding protein-1 [IGFBP-1], IGF binding protein-3 [IGFBP-3], leptin) will be measured by a blood draw at baseline, 3 months and 6 months. Negative least square means indicate a decrease at 3 month comparing to baseline value.|0 and 3 months (change between 0 and 3 months)|11 patients are excluded for missing baseline blood samples.||ng/mL||Standard Error|Least Squares Mean
846823|NCT01106534|Secondary|MACE for Treatment Population||12 through 30 months and 12 through 33 months|Participants enrolled in the study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.|||||
846509|NCT01354431|Primary|Median Progression Free Survival (PFS) at Primary Endpoint - Randomized Population|PFS: time from randomization to date of first disease progression (either clinical or radiographic progression, as assessed by the investigator) and measured in Months. Tumor assessments (radiographic scans) were done every 6 weeks from randomization for the first 12 months, then every 12 weeks until progression. Survival was assessed every 3 months. The analysis of PFS was conducted after approximately 116 events (progression or death), approximately 2 years. PFS was calculated based on investigator’s assessment of first date of progression (either clinical or radiographic progression) or date of death if progression did not occur. Progression was at least a 20% increase in the sum of diameters of the longest target lesions since screening (the sum must be an absolute increase of at least 5 mm), or measurable increase in non-target lesion or appearance of one or more new lesions.|From randomization until after approximately 116 events (disease progression or death), approximately 2 years.|All participants who were randomized to a treatment arm.||Months||80% Confidence Interval|Median
846510|NCT01350934|Other Pre-specified|Extension Study: Percentage of Participants With Serum 25-Hydroxyvitamin (OH) D <20 ng/mL at Month 12|"The term vitamin D insufficiency is used to describe vitamin D levels that are low enough to cause secondary hyperparathyroidism, bone loss, and increased risk of skeletal fracture. In this study, a threshold for vitamin D insufficiency was a level of serum 25(OH) D <20 ng/mL."|Baseline and Month 12|Full Analysis Set (FAS) population, which consisted of all randomized participants who received at least one dose of study treatment, had at least one post-randomization observation for the analysis endpoint subsequent to at least one dose of study treatment, and had baseline data for analyses that required baseline data.||Percentage of Participants|||Number
846511|NCT01350934|Secondary|Extension Study: Percentage Change From Baseline in s-CTx at Month 12|s-CTx is a biochemical marker for bone turnover that has been shown to detect increased bone resorption, a process by which bone is broken down within the body. s-CTx was measured at baseline and Month 12.|Baseline and Month 12|Per-Protocol Set (PPS) population, which consisted of participants who received one dose of study treatment, had baseline measurement and had a Month 12 observation for the analysis endpoint, but excluded participants with at least one major protocol deviation.||Percent change||95% Confidence Interval|Least Squares Mean
846512|NCT01350934|Secondary|Extension Study: Percentage Change From Baseline in s-P1NP at Month 12|s-P1NP is a biochemical marker of bone turnover that is particularly useful in monitoring bone resorption, a process by which bone is broken down within the body. s-P1NP was measured at baseline and Month 12.|Baseline and Month 12|Per-Protocol Set (PPS) population, which consisted of participants who received one dose of study treatment, had baseline measurement and had a Month 12 observation for the analysis endpoint, but excluded participants with at least one major protocol deviation.||Percent change||95% Confidence Interval|Least Squares Mean
846513|NCT01350934|Secondary|Base Study: Percentage Change From Baseline in Serum C-Telopeptides of Type 1 Collagen (s-CTx) at Month 6|s-CTx is a biochemical marker for bone turnover that has been shown to detect increased bone resorption, a process by which bone is broken down within the body. s-CTx was measured at baseline and Month 6.|Baseline and Month 6|Per-Protocol Set (PPS) population, which consisted of participants who received one dose of study treatment, had baseline measurement and had a Month 6 observation for the analysis endpoint, but excluded participants with at least one major protocol deviation.||Percent change||95% Confidence Interval|Least Squares Mean
846514|NCT01350934|Secondary|Base Study: Percentage Change From Baseline in Serum Procollagen Type 1 N-Terminal Propeptide (s-P1NP) at Month 6|s-P1NP is a biochemical marker of bone turnover that is particularly useful in monitoring bone resorption, a process by which bone is broken down within the body. s-P1NP was measured at baseline and Month 6.|Baseline and Month 6|Per-Protocol Set (PPS) population, which consisted of participants who received one dose of study treatment, had baseline measurement and had a Month 6 observation for the analysis endpoint, but excluded participants with at least one major protocol deviation.||Percent change||95% Confidence Interval|Least Squares Mean
846515|NCT01350934|Primary|Extension Study: Percentage Change From Baseline in Lumbar Spine BMD at Month 12|BMD at the lumbar spine was assessed by DXA at baseline and Month 12.|Baseline and Month 12|Full Analysis Set (FAS) population, which consisted of all randomized participants who received at least one dose of study treatment, had at least one post-randomization observation for the analysis endpoint subsequent to at least one dose of study treatment, and had baseline data for analyses that required baseline data.||Percent change||95% Confidence Interval|Least Squares Mean
846516|NCT01350934|Primary|Base Study: Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 6|BMD at the lumbar spine was assessed by dual energy X-ray absorptiometry (DXA) at baseline and Month 6.|Baseline and Month 6|Full Analysis Set (FAS) population, which consisted of all randomized participants who received at least one dose of study treatment, had at least one post-randomization observation for the analysis endpoint subsequent to at least one dose of study treatment, and had baseline data for analyses that required baseline data.||Percent change||95% Confidence Interval|Least Squares Mean
846517|NCT01340300|Other Pre-specified|Changes in Body Composition by Treatment Arm - Waist to Hip Ratio|Negative least square means indicate a decrease at 3 month comparing to baseline value.|0 and 3 months (change between 0 and 3 months)|2 patients are excluded for missing baseline measurements.||ratio||Standard Error|Least Squares Mean
846518|NCT01340300|Other Pre-specified|Changes in Body Composition by Treatment Arm - BMI|Negative least square means indicate a decrease at 3 month comparing to baseline value.|0 and 3 months (change between 0 and 3 months)|2 patients are excluded for missing baseline measurements.||kg/m^2||Standard Error|Least Squares Mean
846519|NCT01340300|Other Pre-specified|Changes in Body Composition by Treatment Arm - Weight|Negative least square means indicate a decrease at 3 month comparing to baseline value.|0 and 3 months (change between 0 and 3 months)|2 patients are excluded for missing baseline measurements.||kg||Standard Error|Least Squares Mean
846520|NCT01340300|Secondary|Change in Fasting Glucose Level|Determine whether supervised exercise training alone and metformin, either alone or in combination can decrease fasting Glucose level from baseline to 3 months in patients who completed standard therapy for stage I-III colorectal or breast cancer. Fasting Glucose levels in blood will be drawn at baseline, 3 months and 6 months. Negative least square means indicate a decrease at 3 month comparing to baseline value.|0 and 3 months (change between 0 and 3 months)|11 patients are excluded for missing baseline blood samples.||mg/dL||Standard Error|Least Squares Mean
846522|NCT01340300|Primary|Change in Fasting Insulin Level|Determine whether supervised exercise training alone and metformin, either alone or in combination can decrease fasting insulin level from baseline to 3 months in patients who completed standard therapy for stage I-III colorectal or breast cancer. Fasting insulin levels in blood will be drawn at baseline, 3 months and 6 months. Negative least square means indicate a decrease at 3 month comparing to baseline value.|0 and 3 months (change between 0 and 3 months)|11 patients are excluded for missing baseline blood samples.||mU/L||Standard Error|Least Squares Mean
846523|NCT01331161|Secondary|The Number of Participants With Innate Immune Signatures That Correlate With the B and T Cells Adaptive Immunity Responses After ZOSTAVAX|The number of participants with innate immune signatures in the young and old groups that correlate with the B and T cells adaptive immunity responses after ZOSTAVAX|2 years|Participants with both T and B cell responses to vaccine||participants|||Number
846524|NCT01331161|Primary|Number of Participants With Innate Immunity Signatures That Correlate With the T Cell Adaptive Immunity Responses After ZOSTAVAX|The primary outcomes will identify the number of participants with innate immunity signatures in the young and older groups that correlate with the T cell adaptive immunity responses after ZOSTAVAX|2 years|participants with immunoglobulin gene responses that correlated with adaptive immune responses||participants|||Number
846525|NCT01309737|Secondary|Family Dermatology Life Quality Index (FDLQI) Score|The FDLQI is a 10-item questionnaire that examine the impact of health-related quality of life issues associated with living with a person with a skin condition (example, emotional distress, personal relationships, reactions of other people, social life, caregiving) over the last month. The FDLQI need to be completed by a family member (for example, spouse or partner, parent) who currently lives with the participant. Each question is scored on a scale from 0 (Not at all/ Not relevant) to 3 (Very much). Total score is calculated by summing the score of each item resulting in a maximum score of '30' and a minimum score of '0'. Higher scores indicate greater impairment to quality of life. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|Baseline, Week 16, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. 'n' signifies participants evaluable at specified time point for each arm, respectively."||units on a scale||Standard Deviation|Mean
846526|NCT01309737|Secondary|Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Psoriasis Affecting Ability to Work|"The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work.The first section assesses direct costs associated with healthcare resource use, and the second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Baseline is the latest pre-dose measurement. Participants rate how much psoriasis affected their ability to work by reporting a number from 0 to 10, where 0 means ability to work was not affected by psoriasis, and 10 means ability to work was completely affected by psoriasis. Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint."|Baseline, Week 16|FAS included participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies participants evaluable at specified time point for each arm, respectively.||units on a scale||Standard Deviation|Mean
846527|NCT01309737|Secondary|Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Percent Absent Hours|The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use, and the second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Baseline is the latest pre-dose measurement. Participants reported hours scheduled to work and hours absent from work. Percent absent hours = (hours absent from work/hours scheduled to work) multiplied by 100. Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|Baseline, Week 16|FAS included participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP compliance issues. 'n' signifies participants evaluable for specified timepoint for each arm, respectively.||percentage of scheduled hours||Standard Deviation|Mean
846528|NCT01309737|Secondary|Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Work Hours and Absent Hours|The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use, and the second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Baseline is the latest pre-dose measurement. Participants reported hours scheduled to work and hours absent from work. Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|Baseline, Week 16|FAS included participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure for specified parameter for each arm, respectively.||hours||Standard Deviation|Mean
846536|NCT01309737|Secondary|Percentage of Participants With Patient Global Assessment (PtGA) Scale Response|The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5-point scale (0=clear [no psoriasis]; 1=almost clear; 2=mild; 3=moderate; 4=severe).|Baseline, Week 2, 4, 8,12,16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively."||percentage of participants|||Number
846824|NCT01106534|Secondary|Major Bleeding for ITT Population||12 through 30 months|Participants enrolled in the study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.|||||
846529|NCT01309737|Secondary|Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Healthcare Resource Use Events and Employment Status|The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use, and the second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Percentage of participants reporting healthcare resource use events and employment status, work impacted events due to psoriasis, and absence or sick leave for work due to psoriasis at Week 16 are reported. Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint.|Week 16|FAS included participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP compliance issues. 'n' signifies participants who were evaluable (answered respective question for this measure) for specified parameter for each arm, respectively.||percentage of participants|||Number
846530|NCT01309737|Secondary|Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Impact of Psoriasis on Work|"The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Participants (currently employed [Emp]) answered (Yes/No [Y/N]): Were you absent or on sick leave from work due to psoriasis today?, and participants (unemployed [UEmp]) answered (Yes/No): Are you unemployed due to your psoriasis? Baseline is the latest pre-dose measurement. Week 16 includes all reported log up to Week 16 (excluding Baseline). Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint."|Baseline, Week 16|FAS included participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.||participants|||Number
846531|NCT01309737|Secondary|Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Interaction With Healthcare Professional|The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use (interactions with healthcare providers such as general practitioners, Dermatologist and Rheumatologist. Baseline is the latest pre-dose measurement. Week 16 includes all reported log data to Week 16 (excluding Baseline). Participants may have response in more than 1 category. Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|Baseline, Week 16|FAS included participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from a site were excluded due to GCP compliance issues. 'n' signifies participants evaluable at specified time point for each arm, respectively.||events|||Number
846532|NCT01309737|Secondary|Euro Quality of Life 5 Dimensions (EQ-5D) - Visual Analog Scale (VAS)|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeter (mm) (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline,Week 16, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively."||mm||Standard Deviation|Mean
846533|NCT01309737|Secondary|Euro Quality of Life 5 Dimensions (EQ-5D) - Health State Profile Utility Score|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Baseline, Week 16, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively."||units on a scale||Standard Deviation|Mean
846534|NCT01309737|Secondary|Joint Pain Assessment (JPA) Score|"The JPA assesses severity of joint pain. The JPA is a horizontal numeric rating scale. Participants were asked to select the number that best describes any joint pain that participant may have experienced over the past 24 hours with response options ranging from 0-no joint pain to 10-worst possible joint pain."|Baseline, Week 8,16, 28, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively."||units on a scale||Standard Deviation|Mean
846535|NCT01309737|Secondary|Percentage of Participants With Patient Satisfaction With Study Medication (PSSM) Score Response|"The PSSM is a single, 7 point item that evaluates overall participant satisfaction with the study treatment. Response options range from very dissatisfied to very satisfied with the study treatment."|Week 16, 28, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively."||percentage of Participants|||Number
846715|NCT01214850|Secondary|Percentages of Subjects With Carriage of N. Meningitidis Serogroup Y at Different Time Points After MenACWY-CRM Vaccination|Percentages of subjects with carriage of N. meningitidis serogroup Y in subjects at different time points of the study after administration of a single dose of MenACWY-CRM conjugate vaccine as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)||Percentages of subjects||95% Confidence Interval|Number
846537|NCT01309737|Secondary|Work Limitation Questionnaire (WLQ) Index Score|WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands Scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). The WLQ Index score is the weighted sum of the scores from the 4 WLQ scales (total score: 0 [no loss] to 100 [complete loss of work]).|Baseline, Week 8, 16, 28, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively."||units on a scale||Standard Deviation|Mean
846538|NCT01309737|Secondary|Hospital Anxiety and Depression Scale (HADS) Score|HADS: 14-item questionnaire that screens for the presence of anxiety and depression symptoms. There are 7 items comprising the anxiety subscale and 7 items comprising the depression subscale. Each item has response options ranging from 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total HADS score ranges from 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.|Baseline, Week 8, 16, 28, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively."||units on a scale||Standard Deviation|Mean
846539|NCT01309737|Secondary|36-Item Short-Form Health Survey Version 2, Acute (SF-36)|36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects are summarized as physical and mental health summary scores. The score range for the physical and mental health scores is 0-100 (100=highest level of functioning).|Baseline, Week 16, 28, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively."||units on a scale||Standard Deviation|Mean
846540|NCT01309737|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. Here 'N' (number of participants analyzed) signifies the unique participants in the longitudinal model.|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues."||units on a scale||Standard Error|Least Squares Mean
846541|NCT01309737|Secondary|Dermatology Life Quality Index (DLQI) Score|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.|Baseline, Week 2, 4, 8,12,16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively."||units on a scale||Standard Deviation|Mean
846542|NCT01309737|Secondary|Change From Baseline in Itch Severity Item (ISI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52|"ISI assessed severity of itch (pruritus) due to psoriasis. ISI is a single item, horizontal numeric rating scale. Participants were asked to rate your worst itching due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms No itching (0) and Worst possible itching (10) at the ends."|Baseline, Week 2, 4, 8,12,16, 20, 28 , 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'N' (number of participants analyzed) signifies the unique participants in the longitudinal model."||units on a scale||Standard Error|Least Squares Mean
846543|NCT01309737|Secondary|Itch Severity Item (ISI) Score|"ISI assessed severity of itch (pruritus) due to psoriasis. ISI is a single item, horizontal numeric rating scale. Participants were asked to rate your worst itching due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms No itching (0) and Worst possible itching (10) at the ends for post baseline time points. Baseline ISI is average of scores on 7 days prior to start of study treatment."|Baseline, Week 2, 4, 8,12,16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively."||units on a scale||Standard Deviation|Mean
846550|NCT01309737|Secondary|Percentage of Participants With Psoriasis Area and Severity Index (PASI) Score of at Least 125% of Baseline PASI Score|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of BSA affected. Basic characteristics of psoriatic lesions: erythema, induration, and scaling (PASI components) are scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]) according to a 5-point scale: 0 (no involvement); 1 (slight); 2 (moderate); 3 (marked); 4 (very marked)."|Week 2, 4, 8,12,16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively."||percentage of participants||95% Confidence Interval|Number
846544|NCT01309737|Secondary|Percentage of Participants With Nail Psoriasis Severity Index 100 (NAPSI 100) Response|The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis. NAPSI 100 response was defined as at least a 100% reduction in NAPSI relative to Baseline. Percentage of participants with NAPSI 100 response is reported. N(number of participants analyzed) signifies participants (with baseline nail psoriasis) who were evaluable for this measure.|Week 8,16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues."||percentage of participants||95% Confidence Interval|Number
846545|NCT01309737|Secondary|Percentage of Participants With Nail Psoriasis Severity Index 75 (NAPSI 75) Response|The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis. NAPSI 75 response was defined as at least a 75% reduction in NAPSI relative to Baseline. Percentage of participants with NAPSI 75 response is reported. N(number of participants analyzed) signifies participants (with baseline nail psoriasis) who were evaluable for this measure.|Week 8, 16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. NRI method (participants with missing values considered as non-responders) was used."||percentage of participants||95% Confidence Interval|Number
846546|NCT01309737|Secondary|Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Week 8, 16, 20, 28, 40 and 52|The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis. 'N' (number of participants analyzed) signifies participants with baseline nail psoriasis and who were unique in longitudinal model.|Baseline,Week 8,16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues."||percent change||Standard Error|Least Squares Mean
846547|NCT01309737|Secondary|Number of Affected Nails|Nail psoriasis is evaluated by the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Total number of psoriasis affected nails (presence of psoriatic manifestations on the nail matrix / nail bed) were assessed and reported. 'N' (number of participants analyzed) signifies participants (with baseline nail psoriasis) who were evaluable for this measure.|Baseline, Week 8, 16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP non-compliance. 'n' signifies participants evaluable at specified time point for each arm."||nails||Standard Deviation|Mean
846548|NCT01309737|Secondary|Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Week 8, 16, 20, 28, 40 and 52|The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis. 'n' signifies participants evaluable at specified time point for each arm.|Baseline,Week 8, 16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP non-compliance. N(number of participants analyzed) signifies participants (with baseline nail psoriasis) who were evaluable for this measure."||units on a scale||Standard Deviation|Mean
846549|NCT01309737|Secondary|Nail Psoriasis Severity Index (NAPSI) Score|The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis.'n' signifies participants evaluable at specified time point for each arm.|Baseline, Week 8, 16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP non-compliance. N(number of participants analyzed) signifies participants (with baseline nail psoriasis) who were evaluable for this measure."||units on a scale||Standard Deviation|Mean
846825|NCT01106534|Secondary|ST for ITT Population||12 through 30 months|Participants enrolled in the study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.|||||
846551|NCT01309737|Secondary|Percentage of Participants With Psoriasis Area and Severity Index 90 (PASI 90) Response|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 90 response was defined as at least a 90% reduction in PASI relative to Baseline. Percentage of participants with PASI 90 response is reported."|Week 2, 4, 8,12,16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. NRI method (participants with missing values considered as non-responders) was used."||percentage of participants||95% Confidence Interval|Number
846552|NCT01309737|Secondary|Percentage of Participants With Psoriasis Area and Severity Index 50 (PASI 50) Response|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of body surface area (BSA) affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 50 response was defined as at least a 50% reduction in PASI relative to Baseline. Percentage of participants with PASI 50 response is reported."|Week 2, 4, 8,12,16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. NRI method (participants with missing values considered as non-responders) was used."||percentage of participants||95% Confidence Interval|Number
846553|NCT01309737|Secondary|Percent Change From Baseline in Total Body Surface Area (BSA) With Psoriasis at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52|Assessment of BSA with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. Body regions are assigned specific number of handprints with percentage [Head and neck = 10% (10 handprints), upper extremities = 20% (20 handprints), Trunk (including axillae and groin) = 30% (30 handprints), lower extremities (including buttocks) = 40% (40 handprints)]. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis. The total BSA affected was the summation of individual regions affected.|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'N'(number of participants analyzed) signifies the unique participants in the longitudinal model."||percent change||Standard Error|Least Squares Mean
846554|NCT01309737|Secondary|Total Body Surface Area (BSA) With Psoriasis|Assessment of BSA with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. Body regions are assigned specific number of handprints with percentage [Head and neck = 10% (10 handprints), upper extremities = 20% (20 handprints), Trunk (including axillae and groin) = 30% (30 handprints), lower extremities (including buttocks) = 40% (40 handprints)]. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis. The total BSA affected was the summation of individual regions affected.|Baseline, Week 2, 4, 8,16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively."||percentage of BSA||Standard Deviation|Mean
846555|NCT01309737|Secondary|Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis."|Baseline, Week 2, 4, 8, 12,16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'N' (number of participants analyzed) signifies the unique participants in the longitudinal model."||percent change||Standard Error|Least Squares Mean
846556|NCT01309737|Secondary|Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of BSA affected. Basic characteristics of psoriatic lesions: erythema, induration, and scaling (PASI components) are scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]) according to a 5-point scale: 0 (no involvement); 1 (slight); 2 (moderate); 3 (marked); 4 (very marked). PASI component score range from 0 to 4 where higher scores indicate greater severity of psoriatic lesions."|Baseline, Week 2, 4, 8,12, 16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively."||units on a scale||Standard Deviation|Mean
846826|NCT01106534|Secondary|MACE for ITT Population||12 through 30 months|Participants enrolled in the study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.|||||
846557|NCT01309737|Secondary|Psoriasis Area and Severity Index (PASI) Component Scores|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of BSA affected. Basic characteristics of psoriatic lesions: erythema, induration, and scaling (PASI components) are scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]) according to a 5-point scale: 0 (no involvement); 1 (slight); 2 (moderate); 3 (marked); 4 (very marked). PASI component score range from 0 to 4 and where higher scores indicate greater severity of psoriatic lesions."|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues.Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively."||units on a scale||Standard Deviation|Mean
846558|NCT01309737|Secondary|Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis."|Baseline, Week 2, 4, 8,12, 16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. N (number of participants analyzed) signifies the unique participants in the longitudinal model."||units on a scale||Standard Error|Least Squares Mean
846559|NCT01309737|Secondary|Psoriasis Area and Severity Index (PASI) Score|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis."|Baseline, Week 2, 4, 8,12,16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively."||units on a scale||Standard Deviation|Mean
846560|NCT01309737|Secondary|Percentage of Participants Achieving Psoriasis Area and Severity Index 75 (PASI 75) Response|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least a 75% reduction in PASI relative to Baseline. Percentage of participants with PASI 75 response is reported."|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. NRI method (participants with missing values considered as non-responders) was used."||percentage of participants||95% Confidence Interval|Number
846561|NCT01309737|Secondary|Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). Percentage of participants with each PGA score is reported.|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues.Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively."||percentage of participants|||Number
846562|NCT01309737|Secondary|Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of ‘Clear’ or ‘Almost Clear’|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. NRI method (participants with missing values considered as non-responders) was used."||percentage of participants||95% Confidence Interval|Number
846601|NCT01276639|Secondary|Percentage of Participants With Patient Satisfaction With Study Medication (PSSM) Score Response|"The PSSM is a single, 7 point item that evaluates overall participant satisfaction with the study treatment. Response options range from very dissatisfied to very satisfied with the study treatment."|Week 16, 28, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here ‘n’ signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.||percentage of participants|||Number
846563|NCT01309737|Secondary|Time to Achieve Psoriasis Area and Severity Index 50 (PASI 50) Response|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 50 response was defined as at least 50% reduction in PASI relative to Baseline. The median time to event was estimated based on the probability of event-rate based on life table estimates (not the observed rate as in outcome measure 26). Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%."|Baseline up to Week 16|FAS participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP compliance issues. Here 'N' signifies those participants who were evaluable for this measure.||weeks||95% Confidence Interval|Median
846564|NCT01309737|Secondary|Time to Achieve Psoriasis Area and Severity Index 75 (PASI 75) Response|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least a 75% reduction in PASI relative to Baseline. The median time to event was estimated based on the probability of event-rate based on life table estimates (not the observed rate as in outcome measure 2). Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%."|Baseline up to Week 16|FAS participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP compliance issues. Here 'N' signifies those participants who were evaluable for this measure.||weeks||95% Confidence Interval|Median
846565|NCT01309737|Secondary|Time to Achieve a Physician Global Assessment (PGA) of Psoriasis Score of ‘Clear’ or ‘Almost Clear’|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). Median time to achieve a PGA response up to week 16 is reported. The median time to event was estimated based on the probability of event-rate based on life table estimates (not the observed rate as in outcome measure 1). Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%.|Baseline up to Week 16|FAS participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP compliance issues. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||weeks||95% Confidence Interval|Median
846566|NCT01309737|Secondary|Percent Probability of Participants Maintaining Psoriasis Area and Severity Index 90 (PASI 90) Response at Week 52|The PASI quantifies severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 90 response = at least 90% reduction in PASI relative to Baseline. Maintenance of PASI 90 response at Week 52 among participants achieving PASI 90 response at Week 16 is reported. Percent probability and 95% CI were estimated based on the product limit estimator in survival analyses. Event is loss of response. Probability of maintaining response is (1-probability of loss of response).|Week 52|FAS participants who had PASI 90 response at Week 16. Data was not analyzed for participants initially randomized to placebo arm as they were re-randomized to active treatment group at Week 16 and thus maintaining response at Week 52 was not relevant. 'N' (number of participants analyzed) = participants with non-missing post-baseline response data.||percent probability of response||95% Confidence Interval|Number
846567|NCT01309737|Secondary|Percent Probability of Participants Maintaining Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 52|The PASI quantifies severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response = at least 75% reduction in PASI relative to Baseline. Maintenance of PASI 75 response at Week 52 among participants achieving PASI 75 response at Week 16 is reported. Percent probability and 95% CI were estimated based on the product limit estimator in survival analyses. Event is loss of response. Probability of maintaining response is (1-probability of loss of response).|Week 52|FAS participants who had PASI 75 response at Week 16. Data was not analyzed for participants initially randomized to placebo arm as they were re-randomized to active treatment group at Week 16 and thus maintaining response at Week 52 was not relevant. 'N' (number of participants analyzed) = participants with non-missing post-baseline response data.||percent probability of response||95% Confidence Interval|Number
846716|NCT01214850|Secondary|Percentages of Subjects With Carriage of N. Meningitidis Genogroup Y at Different Time Points After MenACWY-CRM Vaccination|Percentages of subjects with carriage of N. meningitidis genogroup Y in subjects at different time points of the study after administration of a single dose of MenACWY-CRM conjugate vaccine as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)||Percentages of subjects||95% Confidence Interval|Number
846568|NCT01309737|Secondary|Percent Probability of Participants Maintaining Physician Global Assessment (PGA) of Psoriasis Score of ‘Clear’ or ‘Almost Clear’ at Week 52|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). Maintenance of PGA response at Week 52 among participants achieving PGA response at Week 16 is reported. Percent probability and 95% confidence interval (CI) were estimated based on the product limit estimator in survival analyses. Event is loss of response. Probability of maintaining response is (1-probability of loss of response).|Week 52|FAS participants who had PGA response at Week 16. Data was not analyzed for participants initially randomized to placebo arm as they were re-randomized to active treatment group at Week 16 and thus maintaining response at Week 52 was not relevant. 'N' (number of participants analyzed) = participants with non-missing post-baseline response data.||percent probability of response||95% Confidence Interval|Number
846569|NCT01309737|Secondary|Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) at Week 16|The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis.|Baseline, Week 16|FAS included participants who were randomized to study, received at least 1 dose investigational drug. Participants from 1 site were excluded due to GCP compliance issues. 'N' (number of participants analyzed) were participants who were evaluable (had nail psoriasis at Baseline and had at least one measurement during follow up) for this measure.||percent change||Standard Error|Least Squares Mean
846570|NCT01309737|Primary|Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 16|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of body surface area (BSA) affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least a 75 percent (%) reduction in PASI relative to Baseline."|Week 16|FAS included participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP compliance issues. NRI method (participants with missing values considered as non-responders) was used.||percentage of participants|||Number
846571|NCT01309737|Secondary|Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 4|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least a 75% reduction in PASI relative to Baseline."|Week 4|FAS included participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP compliance issues. NRI method (participants with missing values considered as non-responders) was used.||percentage of participants|||Number
846572|NCT01309737|Secondary|Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of ‘Clear’ or ‘Almost Clear’ at Week 4|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).|Week 4|FAS included participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP compliance issues. NRI method (participants with missing values considered as non-responders) was used.||percentage of participants|||Number
846573|NCT01309737|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 4 and 16|The DLQI is a 10-item general dermatology questionnaire that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.|Baseline, Week 4,16|FAS included participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP compliance issues. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Error|Least Squares Mean
846602|NCT01276639|Secondary|Percentage of Participants With Patient Global Assessment (PtGA) Scale Response|The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5-point scale (0=clear [no psoriasis]; 1=almost clear; 2=mild; 3=moderate; 4=severe).|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here ‘n’ signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.||percentage of participants|||Number
846574|NCT01309737|Secondary|Dermatology Life Quality Index (DLQI) Total Score|The DLQI is a 10-item general dermatology questionnaire that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.|Baseline|FAS included participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP compliance issues. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
846575|NCT01309737|Secondary|Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response at Week 16|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 90 response was defined as at least a 90% reduction in PASI relative to Baseline."|Week 16|FAS included participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP compliance issues. NRI method (participants with missing values considered as non-responders) was used.||percentage of participants|||Number
846576|NCT01309737|Secondary|Percent Change From Baseline in Total Body Surface Area (BSA) With Psoriasis at Week 16|Assessment of BSA with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. Body regions are assigned specific number of handprints with percentage [Head and neck = 10% (10 handprints), upper extremities = 20% (20 handprints), Trunk (including axillae and groin) = 30% (30 handprints), lower extremities (including buttocks) = 40% (40 handprints)]. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis. The total BSA affected was the summation of individual regions affected.|Baseline, Week 16|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP non-compliance. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||percent change||Standard Error|Least Squares Mean
846577|NCT01309737|Primary|Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of ‘Clear’ or ‘Almost Clear’ at Week 16|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).|Week 16|Full analysis set (FAS): participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to good clinical practices(GCP) compliance issues. Non-Responder Imputation (NRI) method (participants with missing values considered as non-responders) was used.||percentage of participants|||Number
846578|NCT01276509|Secondary|The Pharmacokinetics (PK) of Total PF-00547659 - Apparent Clearance (CL/F)|The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. CL/F is apparent clearance.|Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252|All participants who received at least 1 dose of investigational product and had data for at least 1 PK concentration were included in the PK concentration analysis.||mL/hr||Geometric Coefficient of Variation|Geometric Mean
846579|NCT01276509|Secondary|The Pharmacokinetics (PK) of Total PF-00547659 - Terminal Half Life (Thalf)|The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. Thalf is terminal half life.|Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252|All participants who received at least 1 dose of investigational product and had data for at least 1 PK concentration were included in the PK concentration analysis.||Day||Standard Deviation|Mean
846580|NCT01276509|Secondary|The Pharmacokinetics (PK) of Total PF-00547659 - Time for Cmax (Tmax)|The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. Tmax is time for Cmax.|Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252|All participants who received at least 1 dose of investigational product and had data for at least 1 PK concentration were included in the PK concentration analysis.||Hours||Full Range|Median
846581|NCT01276509|Secondary|The Pharmacokinetics (PK) of Total PF-00547659 - Maximum Observed Concentration (Cmax)|The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. Cmax is maximum observed concentration.|Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252|All participants who received at least 1 dose of investigational product and had data for at least 1 PK concentration were included in the PK concentration analysis.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
846582|NCT01276509|Secondary|The Pharmacokinetics (PK) of Total PF-00547659 - Area Under the Concentration Time Profile From Time Zero to Time Tau (AUCtau)|The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. AUCtau is area under the concentration time profile from time zero to time tau, the dosing interval, where tau = 672 hours (4 weeks)|Day 1, 14, and 28|All participants who received at least 1 dose of investigational product and had data for at least 1 PK concentration were included in the PK concentration analysis.||µg•hr/mL||Geometric Coefficient of Variation|Geometric Mean
846583|NCT01276509|Secondary|The Pharmacokinetics (PK) of Total PF-00547659 - Area Under the Concentration Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf)|The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to area under the concentration-time profile (AUC), clearance (CL) and half life were estimated using data pooled from both typical and additional PK groups. AUCinf is area under the concentration time profile from time zero extrapolated to infinite time.|Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252|All participants who received at least 1 dose of investigational product and had data for at least 1 PK concentration were included in the PK concentration analysis.||µg•hr/mL||Geometric Coefficient of Variation|Geometric Mean
846584|NCT01276509|Secondary|Immunogenicity Assessment of Anti-drug Antibodies (ADAs)|Confirmed cumulative incidence of anti-drug antibodies development to PF-00547659|Day 1, Week 4, Week 8, Week 12, Week 20, Week 28, Week 36|The safety analysis set included all participants who receive at least 1 dose of PF-00547659. Participants in placebo arm were not included in this analysis.||events|||Number
846585|NCT01276509|Secondary|Crohn's Disease Activity Index (CDAI) -100 Response Rates Over Timer|Percentage of participants with Crohn's Disease Activity Index (CDAI)-100 response were reported.|Week 2, 4, 6, 8, 10 and 12|The full analysis set included all randomized participants who received at least one dose of study medication.||Percentage of Participants||90% Confidence Interval|Number
846586|NCT01276509|Secondary|Crohn's Disease Activity Index (CDAI)-70 Response Rates Over Time|Percentage of participants with Crohn's Disease Activity Index (CDAI)-70 response were reported.|Week 2, 4, 6, 8, 10 and 12|The full analysis set included all randomized participants who received at least one dose of study medication.||Percentage of Participants||90% Confidence Interval|Number
846587|NCT01276509|Secondary|Percentage of Participants With a Crohn's Disease Activity Index (CDAI) Remission|Percentage of participants with a CDAI remission (defined as a CDAI reduction to <150 points).|Weeks 8 and week 12|The full analysis set included all randomized participants who received at least one dose of study medication.||Percentage of Participants|||Number
846588|NCT01276509|Secondary|Number of Adverse Events (AEs) - PF-00547659 Dose Levels Versus Placebo|Number of adverse events (all causalities and treatment related) was reported between the investigational product groups and the placebo group.|Week 0-12|The safety analysis set included all participants who received at least 1 dose of study medication.||events|||Number
846589|NCT01276509|Secondary|Safety and Tolerability of PF‑00547659 Dose Levels Versus Placebo|Number of participants with adverse events (AEs), withdrawals due to AEs and Serious AEs (SAEs) were reported.|Week 0-12|The safety analysis set included all participants who received at least 1 dose of study medication.||Number of participants|||Number
846590|NCT01276509|Primary|Percentage of Participants With Crohn's Disease Activity Index (CDAI) 70 Response Rate|Crohn's Disease Activity Index (CDAI) is a number which consists of information collected from a 7-day diary from the participants regarding symptoms. Remission is considered a score of 150 or less. Active disease is considered 200 or greater. A response to therapy is considered a decline in CDAI score of 70-points from baseline. CDAI response rate at week 8 and week 12 was measured between the investigational product group and the placebo group.|Week 8 and week 12|The full analysis set included all randomized participants who received at least one dose of study medication.||Percentage of Participants|||Number
846591|NCT01276639|Secondary|Family Dermatology Life Quality Index (FDLQI) Score|The FDLQI is a 10-item questionnaire that examine the impact of health-related quality of life issues associated with living with a person with a skin condition (example, emotional distress, personal relationships, reactions of other people, social life, caregiving) over the last month. The FDLQI need to be completed by a family member (for example, spouse or partner, parent) who currently lives with the participant. Each question is scored on a scale from 0 (Not at all/ Not relevant) to 3 (Very much). Total score is calculated by summing the score of each item resulting in a maximum score of '30' and a minimum score of '0'. Higher scores indicate greater impairment to quality of life.|Baseline, Week 16, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies participants evaluable at specified time point for each arm, respectively.||units on a scale||Standard Deviation|Mean
846592|NCT01276639|Secondary|Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Psoriasis Affecting Ability to Work|The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use, and the second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Baseline is the latest pre-dose measurement. Participants rate how much psoriasis affected their ability to work by reporting a number from 0 to 10, where 0 means “ability to work was not affected by psoriasis”, and 10 means “ability to work was completely affected by psoriasis”. Data was not analyzed beyond Week 16 as per study team’s decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint.|Baseline, Week 16|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies participants evaluable at specified time point for each arm, respectively.||units on a scale||Standard Deviation|Mean
846593|NCT01276639|Secondary|Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Percent Absent Hours|The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use, and the second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Baseline is the latest pre-dose measurement. Participants reported hours scheduled to work and hours absent from work. Percent absent hours = (hours absent from work/hours scheduled to work) multiplied by 100. Data was not analyzed beyond Week 16 as per study team’s decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint.|Baseline, Week 16|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies participants evaluable at specified time point for each arm, respectively.||percentage of scheduled hours||Standard Deviation|Mean
846594|NCT01276639|Secondary|Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Work Hours and Absent Hours|The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use, and the second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Baseline is the latest pre-dose measurement. Participants reported hours scheduled to work and hours absent from work. Data was not analyzed beyond Week 16 as per study team’s decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint.|Baseline, Week 16|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies participants evaluable for specified parameter for each arm, respectively.||hours||Standard Deviation|Mean
846595|NCT01276639|Secondary|Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Healthcare Resource Use Events and Employment Status|The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use, and the second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Percentage of participants reporting healthcare resource use events and employment status, work impacted events due to psoriasis, and absence or sick leave for work due to psoriasis at Week 16 are reported. Data was not analyzed beyond Week 16 as per study team’s decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint.|Week 16|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Here ‘n’ signifies those participants who were evaluable (answered respective question for this measure) for specified parameter for each arm, respectively.||percentage of participants|||Number
846596|NCT01276639|Secondary|Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Impact of Psoriasis on Work|"The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Participants employed at the time of assessment answered (Yes/No [Y/N]): Were you absent or on sick leave from work due to psoriasis today?, and participants unemployed (UEmp) at the time of assessment answered (Yes/No): Are you unemployed due to your psoriasis? Baseline is the latest pre-dose measurement. Week 16 includes all reported log up to Week 16 (excluding Baseline). Data was not analyzed beyond Week 16 as per study team’s decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint."|Baseline, Week 16|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Here ‘n’ signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.||participants|||Number
846597|NCT01276639|Secondary|Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Interaction With Healthcare Professional|The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use (interactions with healthcare providers such as general practitioners, Dermatologist, Rheumatologist). Baseline is the latest pre-dose measurement. Week 16 includes all reported log data to Week 16 (excluding Baseline). Participants may have response in more than 1 category. Data was not analyzed beyond Week 16 as per study team’s decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint.|Baseline, Week 16|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies participants evaluable at specified time point for each arm, respectively.||events|||Number
846598|NCT01276639|Secondary|Euro Quality of Life 5 Dimensions (EQ-5D) - Visual Analog Scale (VAS)|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeter (mm) (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Week 16, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here ‘n’ signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.||mm||Standard Deviation|Mean
846599|NCT01276639|Secondary|Euro Quality of Life 5 Dimensions (EQ-5D) - Health State Profile Utility Score|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Baseline, Week 16, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here ‘n’ signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.||units on a scale||Standard Deviation|Mean
846600|NCT01276639|Secondary|Joint Pain Assessment (JPA) Score|The JPA assesses severity of joint pain. The JPA is a horizontal numeric rating scale. Participants were asked to “select the number that best describes any joint pain that participant may have experienced over the past 24 hours” with response options ranging from “0-no joint pain” to “10-worst possible joint pain.”|Baseline, Week 4, 16, 28, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here ‘n’ signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.||units on a scale||Standard Deviation|Mean
846603|NCT01276639|Secondary|Work Limitation Questionnaire (WLQ) Index Score|WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5 items); Physical Demands scale (6 items); Mental-Interpersonal Demands Scale (9 items); Output Demands Scale (5 items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). The WLQ Index score is the weighted sum of the scores from the 4 WLQ scales (total score: 0 [no loss] to 100 [complete loss of work]).|Baseline, Week 4, 16, 28, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here ‘n’ signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.||units on a scale||Standard Deviation|Mean
846604|NCT01276639|Secondary|Hospital Anxiety and Depression Scale (HADS) Score|HADS: 14-item questionnaire that screens for the presence of anxiety and depression symptoms. There are 7 items comprising the anxiety subscale, and 7 items comprising the depression subscale. Each item has response option ranging from 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score ranges from 0 to 21 for each subscale; higher score indicates greater severity of anxiety or depression symptoms.|Baseline, Week 4, 16, 28, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here ‘n’ signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.||units on a scale||Standard Deviation|Mean
846605|NCT01276639|Secondary|36-Item Short-Form Health Survey Version 2, Acute (SF-36)|36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects are summarized as physical and mental health summary scores. The score range for the physical and mental health scores is 0-100 (100=highest level of functioning).|Baseline, Week 16, 28, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here ‘n’ signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.||units on a scale||Standard Deviation|Mean
846606|NCT01276639|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52|The DLQI is a 10 item general dermatology questionnaire that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Error|Least Squares Mean
846607|NCT01276639|Secondary|Dermatology Life Quality Index (DLQI) Score|The DLQI is a 10 item general dermatology questionnaire that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here ‘n’ signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.||units on a scale||Standard Deviation|Mean
846608|NCT01276639|Secondary|Change From Baseline in Itch Severity Item (ISI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52|"ISI assessed severity of itch (pruritus) due to psoriasis. ISI is a single item, horizontal numeric rating scale. Participants were asked to rate your worst itching due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms No itching (0) and Worst possible itching (10) at the ends."|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Error|Least Squares Mean
846609|NCT01276639|Secondary|Itch Severity Item (ISI) Score|"ISI assessed severity of itch (pruritus) due to psoriasis. ISI is a single item, horizontal numeric rating scale. Participants were asked to rate your worst itching due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms No itching (0) and Worst possible itching (10) at the ends for post baseline time points. Baseline ISI is average of scores on 7 days prior to start of study treatment."|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here ‘n’ signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.||units on a scale||Standard Deviation|Mean
846610|NCT01276639|Secondary|Percentage of Participants With Nail Psoriasis Severity Index 100 (NAPSI 100) Response|The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis. NAPSI 100 response was defined as at least a 100% reduction in NAPSI relative to Baseline. Percentage of participants with NAPSI 100 response is reported.|Week 8, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. NRI method was used to impute missing values.||percentage of participants||95% Confidence Interval|Number
846611|NCT01276639|Secondary|Percentage of Participants With Nail Psoriasis Severity Index 75 (NAPSI 75) Response|The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis. NAPSI 75 response was defined as at least a 75% reduction in NAPSI relative to Baseline. Percentage of participants with NAPSI 75 response is reported.|Week 8, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. NRI method was used to impute missing values.||percentage of participants||95% Confidence Interval|Number
846612|NCT01276639|Secondary|Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Week 8, 16, 20, 28, 40 and 52|The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis.|Baseline, Week 8, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||percent change||Standard Error|Least Squares Mean
846613|NCT01276639|Secondary|Number of Affected Nails|Nail psoriasis is evaluated by the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Total number psoriasis affected nails (presence of psoriatic manifestations on the nail matrix/nail bed) were assessed and reported.|Baseline, Week 8, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies participants evaluable at specified time point for each arm, respectively.||nails||Standard Deviation|Mean
846614|NCT01276639|Secondary|Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Week 8, 16, 20, 28, 40 and 52|The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis.|Baseline, Week 8, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies participants evaluable at specified time point for each arm, respectively.||units on a scale||Standard Deviation|Mean
846615|NCT01276639|Secondary|Nail Psoriasis Severity Index (NAPSI) Score|The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis.|Baseline, Week 8, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies participants evaluable at specified time point for each arm, respectively.||units on a scale||Standard Deviation|Mean
846616|NCT01276639|Secondary|Percentage of Participants With Psoriasis Area and Severity Index (PASI) Score of at Least 125% of Baseline PASI Score|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. Percentage of participants with PASI score of at least 125% of baseline PASI score are reported."|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here ‘n’ signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.||percentage of participants||95% Confidence Interval|Number
846617|NCT01276639|Secondary|Percentage of Participants With Psoriasis Area and Severity Index 90 (PASI 90) Response|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 90 response was defined as at least 90% reduction in PASI relative to Baseline. Percentage of participants with PASI 90 response up to Week 52 is reported."|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS: all randomized participants who received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. NRI method was used to impute missing values.||percentage of participants||95% Confidence Interval|Number
846618|NCT01276639|Secondary|Percentage of Participants With Psoriasis Area and Severity Index 50 (PASI 50) Response|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 50 response was defined as at least 50% reduction in PASI relative to Baseline. Percentage of participants with PASI 50 response is reported."|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS: all randomized participants who received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. NRI method was used to impute missing values.||percentage of participants||95% Confidence Interval|Number
846619|NCT01276639|Secondary|Percent Change From Baseline in Total Body Surface Area (BSA) With Psoriasis at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52|Assessment of BSA with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. Body regions are assigned specific number of handprints with percentage [Head and neck = 10% (10 handprints), upper extremities = 20% (20 handprints), Trunk (including axillae and groin) = 30% (30 handprints), lower extremities (including buttocks) = 40% (40 handprints)]. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis. The total BSA affected was the summation of individual regions affected.|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||percent change||Standard Error|Least Squares Mean
846620|NCT01276639|Secondary|Total Body Surface Area (BSA) With Psoriasis|Assessment of BSA with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. Body regions are assigned specific number of handprints with percentage [Head and neck = 10% (10 handprints), upper extremities = 20% (20 handprints), Trunk (including axillae and groin) = 30% (30 handprints), lower extremities (including buttocks) = 40% (40 handprints)]. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis. The total BSA affected was the summation of individual regions affected.|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here ‘n’ signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.||percentage of BSA||Standard Deviation|Mean
846621|NCT01276639|Secondary|Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis."|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||percent change||Standard Error|Least Squares Mean
846622|NCT01276639|Secondary|Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52|The PASI quantifies the severity of a participant's psoriasis based on both, “lesion severity” and the “percent of body surface area (BSA)” affected. Basic characteristics of psoriatic lesions: erythema, induration, and scaling (PASI components) are scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]) according to a 5-point scale: 0 (no involvement); 1 (slight); 2 (moderate); 3 (marked); 4 (very marked). PASI component score range from 0 to 4, where higher scores indicate greater severity of psoriatic lesions.|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here ‘n’ signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.||units on a scale||Standard Deviation|Mean
846623|NCT01276639|Secondary|Psoriasis Area and Severity Index (PASI) Component Scores|The PASI quantifies the severity of a participant's psoriasis based on both, “lesion severity” and the “percent of BSA” affected. Basic characteristics of psoriatic lesions: erythema, induration, and scaling (PASI components) are scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]) according to a 5-point scale: 0 (no involvement); 1 (slight); 2 (moderate); 3 (marked); 4 (very marked). PASI component score range from 0 to 4, where higher scores indicate greater severity of psoriatic lesions.|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here ‘n’ signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.||units on a scale||Standard Deviation|Mean
846624|NCT01276639|Secondary|Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis."|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Error|Least Squares Mean
846625|NCT01276639|Secondary|Psoriasis Area and Severity Index (PASI) Score|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis."|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here ‘n’ signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.||units on a scale||Standard Deviation|Mean
846626|NCT01276639|Secondary|Percentage of Participants Achieving Psoriasis Area and Severity Index 75 (PASI 75) Response|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least 75% reduction in PASI relative to Baseline. Percentage of participants with PASI 75 response is reported."|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS: all randomized participants who received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. NRI method was used to impute missing values.||percentage of participants||95% Confidence Interval|Number
846627|NCT01276639|Secondary|Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). Percentage of participants with each PGA score is reported.|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. NRI method was used to impute missing values. Here ‘n’ signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.||percentage of participants|||Number
846628|NCT01276639|Secondary|Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of ‘Clear’ or ‘Almost Clear’|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS: all randomized participants who received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. NRI method was used to impute missing values.||percentage of participants||95% Confidence Interval|Number
846827|NCT01106534|Primary|Major Bleeding (GUSTO Classification, Severe and Moderate Bleeding Combined)||12-33 months post-stent|Participants enrolled in the study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.|||||
846629|NCT01276639|Secondary|Time to Achieve Psoriasis Area and Severity Index 50 (PASI 50) Response|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 50 response was defined as at least 50% reduction in PASI relative to Baseline. The median time to event was estimated based on the probability of event-rate based on life table estimates (not the observed rate as in outcome measure 26). Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%."|Baseline up to Week 16|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||weeks||95% Confidence Interval|Median
846630|NCT01276639|Secondary|Time to Achieve Psoriasis Area and Severity Index 75 (PASI 75) Response|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least 75% reduction in PASI relative to Baseline. The median time to event was estimated based on the probability of event-rate based on life table estimates (not the observed rate as in outcome measure 2). Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%."|Baseline up to Week 16|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||weeks||95% Confidence Interval|Median
846631|NCT01276639|Secondary|Time to Achieve a Physician Global Assessment (PGA) of Psoriasis Score of ‘Clear’ or ‘Almost Clear’|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). Median time to achieve a PGA response up to week 16 is reported. The median time to event was estimated based on the probability of event-rate based on life table estimates (not the observed rate as in outcome measure 1). Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%.|Baseline up to Week 16|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||weeks||95% Confidence Interval|Median
846632|NCT01276639|Secondary|Percent Probability of Participants Maintaining Psoriasis Area and Severity Index 90 (PASI 90) Response at Week 52|The PASI quantifies severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 90 response = at least 90% reduction in PASI relative to Baseline. Maintenance of PASI 90 response at Week 52 among participants achieving PASI 90 response at Week 16 is reported. Percent probability and 95% CI were estimated based on the product limit estimator in survival analyses. Event is loss of response. Probability of maintaining response is (1-probability of loss of response).|Week 52|FAS participants who had PASI 90 response at Week 16. Data was not analyzed for participants initially randomized to placebo arm as they were re-randomized to active treatment group at Week 16 and thus maintaining response at Week 52 was not relevant. 'N' (number of participants analyzed) = participants with non-missing post-baseline response data.||percent probability of response||95% Confidence Interval|Number
846633|NCT01276639|Secondary|Percent Probability of Participants Maintaining Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 52|The PASI quantifies severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response = at least 75% reduction in PASI relative to Baseline. Maintenance of PASI 75 response at Week 52 among participants achieving PASI 75 response at Week 16 is reported. Percent probability and 95% CI were estimated based on the product limit estimator in survival analyses. Event is loss of response. Probability of maintaining response is (1-probability of loss of response).|Week 52|FAS participants who had PASI 75 response at Week 16. Data was not analyzed for participants initially randomized to placebo arm as they were re-randomized to active treatment group at Week 16 and thus maintaining response at Week 52 was not relevant. 'N' (number of participants analyzed) = participants with non-missing post-baseline response data.||percent probability of response||95% Confidence Interval|Number
846701|NCT01214850|Secondary|The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group.|The hSBA Geometric Mean Titers (GMTs) against the three strains of N. meningitidis serogroup B, after rMenB+OMV NZ or MenACWY-CRM vaccination at different time points of the study as compared to the control group are reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Immunogenicity subset)||Titers||95% Confidence Interval|Geometric Mean
846634|NCT01276639|Secondary|Percent Probability of Participants Maintaining Physician Global Assessment (PGA) of Psoriasis Score of ‘Clear’ or ‘Almost Clear’ at Week 52|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). Maintenance of PGA response at Week 52 among participants achieving PGA response at Week 16 is reported. Percent probability and 95% confidence interval (CI) were estimated based on the product limit estimator in survival analyses. Event is loss of response. Probability of maintaining response is (1-probability of loss of response).|Week 52|FAS participants who had PGA response at Week 16. Data was not analyzed for participants initially randomized to placebo arm as they were re-randomized to active treatment group at Week 16 and thus maintaining response at Week 52 was not relevant. 'N' (number of participants analyzed) = participants with non-missing post-baseline response data.||percent probability of response||95% Confidence Interval|Number
846635|NCT01276639|Secondary|Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) at Week 16|The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis.|Baseline, Week 16|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Here 'N' (number of participants analyzed) signifies those participants who were evaluable (had nail psoriasis at Baseline and had at least one measurement during follow up) for this measure.||percent change||Standard Error|Least Squares Mean
846636|NCT01276639|Secondary|Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 4|The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least 75% reduction in PASI relative to Baseline.|Week 4|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). NRI method (participants with missing values considered as non-responders) was used to impute missing values.||percentage of participants|||Number
846637|NCT01276639|Secondary|Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of ‘Clear’ or ‘Almost Clear’ at Week 4|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).|Week 4|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). NRI method (participants with missing values considered as non-responders) was used to impute missing values.||percentage of participants|||Number
846638|NCT01276639|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 4 and 16|The DLQI is a 10 item general dermatology questionnaire that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.|Week 4, 16|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Error|Least Squares Mean
846639|NCT01276639|Secondary|Dermatology Life Quality Index (DLQI) Total Score|The DLQI is a 10 item general dermatology questionnaire that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.|Baseline|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
846640|NCT01276639|Secondary|Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response at Week 16|The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 90 response was defined as at least a 90% reduction in PASI relative to Baseline.|Week 16|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). NRI method (participants with missing values considered as non-responders) was used to impute missing values.||percentage of participants|||Number
846641|NCT01276639|Secondary|Percent Change From Baseline in Total Body Surface Area (BSA) With Psoriasis at Week 16|Assessment of BSA with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. Body regions are assigned specific number of handprints with percentage [Head and neck = 10% (10 handprints), upper extremities = 20% (20 handprints), Trunk (including axillae and groin) = 30% (30 handprints), lower extremities (including buttocks) = 40% (40 handprints)]. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis. The total BSA affected was the summation of individual regions affected.|Baseline, Week 16|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||percent change||Standard Error|Least Squares Mean
846642|NCT01276639|Primary|Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 16|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of body surface area (BSA) affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least a 75 percent (%) reduction in PASI relative to Baseline."|Week 16|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). NRI method (participants with missing values considered as non-responders) was used to impute missing values.||percentage of participants|||Number
846643|NCT01276639|Primary|Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of ‘Clear’ or ‘Almost Clear’ at Week 16|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).|Week 16|Full analysis set (FAS) included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Non-Responder Imputation (NRI) method (participants with missing values considered as non-responders) was used to impute missing values.||percentage of participants|||Number
846681|NCT01257542|Secondary|Participants' Global Assessment of Cough: Relief From Cough|Participant global assessment of cough with the assistance of parent or legal guardian was scored on a 5-point categorical scale based on response to the question “From when you woke up this morning until now, how much better is your cough?” where 0 = not at all better, 1 = a tiny bit better, 2 = a little better, 3 = better and 4 = a lot better.|Within 5 minutes after Hour 6|ITT population included all randomized participants who received study medication, provided baseline efficacy data and any post baseline assessment.||Units on a scale||Standard Deviation|Mean
846682|NCT01257542|Secondary|Participants' Global Assessment of Cough: Cough Severity|"Participant global assessment of cough with the assistance of parent or legal guardian was scored on a 5-point categorical scale based on response to the question  How much have you coughed in the past 6 hours?” where 0 = not at all, 1 = a tiny bit, 2 = a little, 3 = some and 4 = a lot."|Within 5 minutes after Hour 6|ITT population included all randomized participants who received study medication, provided baseline efficacy data and any post baseline assessment.||Units on a scale||Standard Deviation|Mean
846683|NCT01257542|Secondary|Change From Baseline in Numerical Cough Severity Scale at Hours 1, 2, 3, 4, 5 and 6|Numerical cough severity score was assessed on an 11-point categorical rating scale in accordance to the question “How much have you coughed in the last hour?”, wherein 0 = did not cough at all and 10 = cough a lot. The change from baseline was derived by subtracting the post baseline value from the baseline value and ranged from -10 to 10; higher score indicated a better improvement.|Baseline, 1, 2, 3, 4, 5, 6 hours|ITT population included all randomized participants who received study medication, provided baseline efficacy data and any post baseline assessment.||Units on a scale||Standard Deviation|Mean
846684|NCT01257542|Secondary|Change From Baseline in Perceived Numerical Cough Severity Scale for 6 Hour Post-Dose Period|Perceived numerical cough severity score was assessed on an 11-point categorical rating scale in accordance to the question “How much have you coughed in the last hour?”, where 0 = did not cough at all and 10 = cough a lot. The change from baseline for the 6-hour post-dosing period was calculated as the average of change from baseline (i.e. baseline value minus the post baseline value) measurements of Hour 1 to Hour 6, thus the change from baseline values ranged from -10 to 10; higher score indicated a better improvement.|Baseline, 1, 2, 3, 4, 5, 6 hour post-dose|ITT population included all randomized participants who received study medication, provided baseline efficacy data and any post baseline assessment.||Units on a scale||Standard Deviation|Mean
846685|NCT01257542|Secondary|Change From Baseline in Verbal Cough Severity Scale at Hours 1, 2, 3, 4, 5 and 6|Verbal cough severity score was assessed on a 5-point categorical rating scale in accordance to the question “How much have you coughed in the last hour?”, where 0 = not at all, 1 = a tiny bit, 2 = a little, 3 = some and 4 = a lot. The change from baseline values were derived by subtracting each post baseline value from the baseline value, and ranged from -4 to 4; higher score indicated a better improvement.|Baseline, 1, 2, 3, 4, 5, 6 hours|ITT population included all randomized participants who received study medication, provided baseline efficacy data and any post baseline assessment.||Units on a scale||Standard Deviation|Mean
846686|NCT01257542|Secondary|Change From Baseline in Perceived Verbal Cough Severity Scale for 6 Hour Post-Dose Period|Perceived verbal cough severity score was assessed on a 5-point categorical rating scale in accordance to the question “How much have you coughed in the last hour?”, where 0 = not at all, 1 = a tiny bit, 2 = a little, 3 = some and 4 = a lot. The change from baseline over the 6-hour post-dosing period calculated as the average of change from baseline [that is (i.e.) baseline value minus the post baseline value] measurements of Hour 1 to Hour 6, thus the change from baseline ranged from -4 to 4; higher score indicated a better improvement.|Baseline, 1, 2, 3, 4, 5, 6 hours post-dose|ITT population included all randomized participants who received study medication, provided baseline efficacy data and any post baseline assessment.||Units on a scale||Standard Deviation|Mean
846687|NCT01257542|Primary|Total Cough Count|Total cough count was done by trained assessors using continuous digital video and audio recordings.|Up to 6 hours post-dose|Intent-to-treat (ITT) population included all randomized participants who received study medication, provided baseline efficacy data and any post baseline assessment.||Cough counts||Standard Deviation|Mean
846688|NCT01232868|Secondary|Number of Participants With Specific B Cell Responses That Correlate With the Innate Immune Signatures|The secondary outcomes will identify the number of participants with a positive B cell response to the flu shot particulary looking for antibody responses, presence of plasmablasts, antibody repertoire.|2 years|||participants|||Number
846689|NCT01232868|Primary|Efficacy, Measured by the Number of Subjects With a Change in Innate Immune Signatures|The number of subjects with a change in innate immunity signatures correlating with the level of antibodies was recorded. The innate immune signatures were assessed by Fluorescence Activated Cell Sorting (FACS)/Luminex assays. The levels of antibodies to the influenza virus prior to TIV (trivalent influenza vaccine) administration and on Day 180 after receiving TIV was assessed and the number of subjects who exhibited an increase in the antibodies and, therefore, a change in their innate immune signatures, was recorded.|Day 0 (prior to TIV administration), Day 180 (from the time of of TIV administration)|||participants|||Number
846690|NCT01228734|Secondary|Number of Subjects With Curative Surgery of Liver Metastases|The number of subjects who underwent liver metastatic surgery after start of treatment and the outcome of surgery with respect to residual tumor after surgery (R0, R1, R2, not evaluable) were summarized. In case of resection of more than one metastasis, the worst outcome of surgery defined the overall status of a subject. R0 = No residual tumor after resection (all lesions resected completely); R1 = Metastases not resected completely with microscopic residual lesions; and R2 = Metastases not resected completely with macroscopic residual lesions.|Baseline up to 209 weeks|"MITT population included all subjects with RAS wild-type tumor status who were randomized to study treatment and who received at least 1 dose of study treatment. Subjects were analyzed as randomized. Here Number Analyzed signifies those subjects who were evaluable for the specified categories."||subjects|||Number
846714|NCT01214850|Secondary|Percentages of Subjects With New Acquisition of Pharyngeal Carriage of All ST Types of N. Meningitidis Genogroup B at Different Time Points Following rMenB+OMV NZ Vaccination|The percentages of subjects with newly acquired pharyngeal carriage of all ST types of N. meningitidis genogroup B in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)||Percentages of subjects||95% Confidence Interval|Number
846691|NCT01228734|Secondary|Time to Treatment Failure (TTF)|TTF was defined as time from randomization to date of the first occurrence of radiologically confirmed PD as determined by IRC, Clinical PD according to the Investigator’s assessment (if radiological confirmation of PD by IRC was unavailable), discontinuation of treatment due to progression or adverse event, start of new anticancer therapy, withdrawal of consent, or death within 90 days of last tumor assessment or randomization. Subjects without event were censored on the date of last tumor assessment.|Baseline up to 277 weeks|MITT population included all subjects with RAS wild-type tumor status who were randomized to study treatment and who received at least 1 dose of study treatment. Subjects were analyzed as randomized.||months||95% Confidence Interval|Median
846692|NCT01228734|Secondary|Best Overall Response Rate (ORR)|The Best ORR was defined as the percentage of subjects having achieved complete response (CR) or partial response (PR) according to RECIST version 1.0 as determined by the IRC. CR: defined as disappearance of all target and all non-target lesions and no new lesions. PR: defined as at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters, no progression of non-target lesions and no new lesions.|Baseline up to 246 weeks|MITT population included all subjects with RAS wild-type tumor status who were randomized to study treatment and who received at least 1 dose of study treatment. Subjects were analyzed as randomized.||percentage of subjects||95% Confidence Interval|Number
846693|NCT01228734|Secondary|Overall Survival (OS) Time|OS was defined as the time (in months) from randomization to death. For subjects who were still alive at the analysis data cut-off date or who lost to follow-up, survival was censored at the last recorded date that the subject was known to be alive.|Baseline up to 277 weeks|MITT population included all subjects with RAS wild-type tumor status who were randomized to study treatment and who received at least 1 dose of study treatment. Subjects were analyzed as randomized.||months||95% Confidence Interval|Median
846694|NCT01228734|Primary|Progression Free Survival (PFS) Time|PFS was defined as the duration (in months) from randomization until the first progressive disease (PD) observation as assessed by the Independent Review Committee (IRC) according to Response Evaluation Criteria for Solid Tumors (RECIST) version 1.0, or death due to any cause when death occurred within 90 days of randomization or the last tumor assessment, whichever was later. PD was defined as at least a 20% increase in the sum of longest diameter (LD) of the target lesions, taking as references the smallest sum LD since the treatment started (including baseline), or appearance of one or more new lesions, and/or unequivocal progression of existing non-target lesions.|Baseline up to 246 weeks|MITT population included all subjects with RAS wild-type tumor status who were randomized to study treatment and who received at least 1 dose of study treatment. Subjects were analyzed as randomized.||months||95% Confidence Interval|Median
846695|NCT01214850|Secondary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group|The safety and tolerability of two doses of rMenB+OMV NZ vaccine (Group rMenB+OMV) and one dose of MenACWY-CRM vaccine (Group MenACWY) was assessed in terms of number of subjects with solicited local and systemic adverse events and other adverse events, following vaccination and compared to that of the control group.|Day 1 through day 7 after any vaccination|Analysis was done on the Immunogenicity Subset, Safety Population i.e. all subjects in the exposed population who provided postvaccination safety data.||number of subjects|||Number
846696|NCT01214850|Secondary|Percentages of Subjects (Who Have Received a Prior Dose of MenC Vaccine) With hSBA Titers ≥1:8 Against N. Meningitidis Serogroups C and Y After Vaccination With MenACWY-CRM in This Study Compared to Control Group.|"The percentages of subjects (who have received a prior dose of MenC vaccine) with hSBA titers ≥1:8 against N. meningitidis serogroups C and Y after receiving MenACWY-CRM vaccination in this study as compared to the control group are reported.
Analysis was not done for serogroups A and W."|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Immunogenicity subset)||Percentages of subjects||95% Confidence Interval|Number
846697|NCT01214850|Secondary|The hSBA Geometric Mean Titers Against N. Meningitidis Serogroups C and Y in Subjects (Who Have Received a Prior Dose of MenC Vaccine) After Vaccination With MenACWY-CRM in This Study Compared to Control Group|"The hSBA geometric mean titers against the N. meningitidis serogroups C and Y in subjects (who have received a prior dose of MenC vaccine) after MenACWY-CRM vaccination at different time points of the study as compared to the control group are reported.
Analysis was not done for serogroups A and W."|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Immunogenicity subset)||Titers||95% Confidence Interval|Geometric Mean
846698|NCT01214850|Secondary|Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups C and Y After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group.|"The percentages of subjects with hSBA seroresponse against N. meningitidis serogroups C and Y, after rMenB+OMV NZ or MenACWY-CRM vaccination as compared to the control group are reported.
Seroresponse to N. meningitidis serogroups Cand Y is defined as :(1)for subjects with a pre-vaccination hSBA titer < 1:4 to a post-vaccination hSBA titer ≥ 1:8 or (2) for subjects with a pre-vaccination hSBA titer ≥ 1:4, an increase in hSBA titer of at least four times the pre-vaccination titer.
Analysis was not done for serogroups A and W."|61 days|Analysis was done on the MITT dataset (Immunogenicity subset)||Percentages of subjects||95% Confidence Interval|Number
846699|NCT01214850|Secondary|The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group.|"The hSBA antibody titers against N. meningitidis serogroups C and Y after rMenB+OMV NZ or MenACWY-CRM vaccination at different time points of the study as compared to the control group, are reported as GMTs.
Serogroups A and W were not analysed."|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Immunogenicity subset)||Titers||95% Confidence Interval|Geometric Mean
846700|NCT01214850|Secondary|Percentages of Subjects With hSBA Titers ≥1:8 Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group.|"The percentages of subjects with hSBA titers ≥1:8 against N. meningitidis serogroups C and Y, after rMenB+OMV NZ or MenACWY-CRM vaccination at different time points of the study as compared to the control group are reported.
As serogroup A and W strains were not detected in substantial proportion of subjects during pharyngeal carriage analysis, these serogroups were not tested."|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Immunogenicity subset)||Percentages of subjects||95% Confidence Interval|Number
848370|NCT00051363|Other Pre-specified|Functional Magnetic Resonance Imaging (fMRI)||Measured at diagnostic visit (baseline) and 6 months post intervention|fMRI was dropped as a secondary outcome measure for analysis by our Core Team.|||||
846702|NCT01214850|Secondary|Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group|The percentages of subjects with hSBA titers ≥1:4 against the three strains of N. meningitidis B, after rMenB+OMV NZ or MenACWY-CRM vaccination at different time points of the study as compared to the control group are reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Immunogenicity subset) i.e all enrolled subjects who actually received a study vaccination, provided at least one evaluable serum sample after vaccination and whose assay result was available for at least one serogroup.||Percentages of subjects||95% Confidence Interval|Number
846703|NCT01214850|Secondary|Percentages of Subjects With N. Meningitidis Carriage of Serogroup Y After MenACWY-CRM Vaccination, Stratified by Pre-vaccination hSBA Titers|The prevalence of carriage of N. meningitidis serogroup Y, at different time points of the study, in subjects stratified by pre-vaccination hSBA (<8 and ≥8) titers, after administration of one dose of MenACWY-CRM vaccine as compared to the control group is reported.|Up to 12 months after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)||Percentages of subjects||95% Confidence Interval|Number
846704|NCT01214850|Secondary|Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination|"The percentages of subjects with N. meningitidis Virulent ST of serogroup B, at different time points of the study, in subjects stratified by pre-vaccination hSBA (<4 and ≥4) titers after administration of two doses of rMenB+OMV NZ vaccine as compared to the control group is reported.
The serum bactericidal antibodies directed against N.meningitides serogroups, are measured by Serum Bactericidal Assay using human complement (hSBA).
H44/76, 5/99 and NZ98/254 are strains in serogroup B."|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)||Percentage||95% Confidence Interval|Number
846705|NCT01214850|Secondary|The Duration of Carriage After New Acquisition N.Meningitidis Strains Following Vaccination With MenACWY Vaccine|The duration of carriage after new acquisition of N.meningitidis strains after receiving one dose of MenACWY-CRM vaccine compared to that in the control group is reported.|Any post vaccination timepoint (the date of first observation of the carriage and the date of the last observation of the carriage)|Analysis was done on the MITT dataset (Pharyngeal carriage)||Number of days||95% Confidence Interval|Least Squares Mean
846706|NCT01214850|Secondary|The Duration of Carriage After New Acquisition N.Meningitidis Strains Following Vaccination With rMenB+OMV Vaccine|The duration of carriage after new acquisition of N.meningitidis strains after receiving two doses of rMenB+OMV vaccine compared to that in the control group is reported.|Any post vaccination timepoint (the date of first observation of the carriage and the date of the last observation of the carriage)|Analysis was done on the MITT dataset (Pharyngeal carriage)||Number of days||95% Confidence Interval|Least Squares Mean
846707|NCT01214850|Secondary|The Duration of Carriage of Any N. Meningitidis Strain After Vaccination With MenACWY-CRM|The duration of carriage of any N meningitidis strain after receiving one dose MenACWY-CRM as compared to that in control group is reported.|Any time post vaccination (the date of first observation of the carriage and the date of the last observation of the carriage)|Analysis was done on the MITT dataset (Pharyngeal carriage)||Number of days||95% Confidence Interval|Least Squares Mean
846708|NCT01214850|Secondary|The Duration of Any Carriage of N.Meningitidis Strains After Vaccination With rMenB+OMV|The duration of carriage of any N.meningitidis strains after receiving two doses of rMenB+OMV compared to that in the control group is reported.|Any post vaccination timepoint (the date of first observation of the carriage and the date of the last observation of the carriage)|Analysis was done on the MITT dataset (Pharyngeal carriage)||Number of days||95% Confidence Interval|Least Squares Mean
846709|NCT01214850|Secondary|Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Serogroup Y at Different Time-points After MenACWY-CRM Vaccination|The percentages of subjects with newly acquired pharyngeal carriage of N.meningitidis serogroup Y at different time-points in the study after MenACWY-CRM vaccination as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)||Percentages of subjects||95% Confidence Interval|Number
846710|NCT01214850|Secondary|Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Serogroups ACWY at Different Time-points After MenACWY-CRM Vaccination|The percentages of subjects with newly acquired pharyngeal carriage of N.meningitidis serogroups A,C, W or Y at different time-points in the study after MenACWY-CRM vaccination as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)||Percentages of subjects||95% Confidence Interval|Number
846711|NCT01214850|Secondary|Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Genogroups ABCWY at Different Time Points Following rMenB+OMV NZ Vaccination|The percentages of subjects with newly acquired pharyngeal carriage of N. meningitidis genogroups ABCWY in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)||Percentages of subjects||95% Confidence Interval|Number
846712|NCT01214850|Secondary|Percentages of Subjects With New Acquisition of Pharyngeal Carriage of All N. Meningitidis at Different Time Points Following rMenB+OMV NZ Vaccination|The percentages of subjects with newly acquired pharyngeal carriage of all N. meningitidis in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)||Percentages of subjects||95% Confidence Interval|Number
846713|NCT01214850|Secondary|Percentages of Subjects With New Acquisition of Pharyngeal Carriage of Virulent ST Types of N. Meningitidis Genogroup B at Different Time Points Following rMenB+OMV NZ Vaccination|The percentages of subjects with newly acquired pharyngeal carriage of virulent ST types of N. meningitidis genogroup B in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)||Percentages of subjects||95% Confidence Interval|Number
846828|NCT01106534|Primary|Incidence of ARC Definite or Probable ST||12-33 months post-stent|Participants enrolled in the study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.|||||
846717|NCT01214850|Secondary|Percentages of Subjects With Carriage of N. Meningitidis Serogroups ACWY at Different Time Points After MenACWY-CRM Vaccination|Percentages of subjects with carriage of N. meningitidis serogroups ACWY in subjects at different time points of the study after administration of a single dose of MenACWY-CRM conjugate vaccine as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)||Percentages of subjects||95% Confidence Interval|Number
846718|NCT01214850|Secondary|Percentages of Subject With Carriage of N. Meningitidis Genogroups ACWY at Different Time Points After MenACWY-CRM Vaccination|Percentages of subject with carriage of N. meningitidis genogroups ACWY in subjects at different time points of the study after administration of a single dose of MenACWY-CRM conjugate vaccine as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)||Percentages of subjects||95% Confidence Interval|Number
846719|NCT01214850|Secondary|Percentages of Subjects With Carriage of N.Meningitidis Serogroup Y at Different Time Points After rMenB+OMV NZ Vaccination|Percentages of subjects with carriage of N.meningitidis serogroup Y in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ vaccine as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)||Percentages of subjects||95% Confidence Interval|Number
846720|NCT01214850|Secondary|Percentages of Subjects With Carriage of N.Meningitidis Genogroup Y at Different Time Points After rMenB+OMV NZ Vaccination|Percentages of subjects with carriage of N.meningitidis genogroup Y in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ vaccine as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MIIT dataset (Pharyngeal carriage)||Percentages of subjects||95% Confidence Interval|Number
846721|NCT01214850|Secondary|Percentages of Subjects With Carriage of N.Meningitidis Serogroups A,C,W or Y at Different Time Points After rMenB+OMV NZ Vaccination|Percentages of subjects with carriage of N.meningitidis serogroups A,C,W or Y in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ vaccine as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)||Percentages of subjects||95% Confidence Interval|Number
846722|NCT01214850|Secondary|Percentages of Subjects With Carriage of N.Meningitidis ACWY Genogroups at Different Time Points After rMenB+OMV NZ Vaccination|Percentages of subjects with carriage of N.meningitidis ACWY genogroups in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ vaccine as compared to the control group is reported|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)||Percentages of subjects||95% Confidence Interval|Number
846723|NCT01214850|Secondary|Percentages of Subjects With Carriage of N.Meningitidis ABCWY Genogroups at Different Time Points After rMenB+OMV NZ Vaccination|Percentages of subjects with carriage of N.meningitidis ABCWY genogroups in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ vaccine as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)||Percentages of subjects||95% Confidence Interval|Number
846724|NCT01214850|Secondary|Percentages of Subjects With Carriage of All N.Meningitidis Strain at Different Time Points After rMenB+OMV NZ Vaccination|Percentage of subjects with carriage of all N.meningitidis strains combined in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ vaccine as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)||Percentages of subjects||95% Confidence Interval|Number
846725|NCT01214850|Secondary|Percentages of Subjects With Carriage of Nonvirulent ST Types of N. Meningitidis Group B at Any Time Point After rMenB+OMV NZ Vaccination|Percentage of subjects with carriage of nonvirulent ST types of N. meningitidis group B (genogroupable) in subjects at different time points of the study point after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)||Percentages of subjects||95% Confidence Interval|Number
846726|NCT01214850|Secondary|Percentages of Subjects With Carriage of Virulent ST Types of N. Meningitidis Group B at Any Time Point After rMenB+OMV NZ Vaccination|Percentage of subjects with carriage of virulent ST types of N. meningitidis group B (genogroupable) in subjects at different time points of the study point after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)||Percentages of subjects||95% Confidence Interval|Number
846727|NCT01214850|Secondary|Percentages of Subjects With Carriage of All ST Types of N. Meningitidis B (Genogroupable) at Different Time Points Following rMenB+OMV NZ Vaccination|The percentage of subjects with carriage of all (virulent + non-virulent) ST types of N. meningitidis B (genogroupable) in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)||Percentages of subjects||95% Confidence Interval|Number
846728|NCT01214850|Primary|Percentages of Subjects With Combined Carriage of N. Meningitidis Serogroups A, C, W and Y, One Month After MenACWY-CRM Vaccination|The percentage of subjects with combined carriage rate of N. meningitidis serogroups A, C, W and Y in subjects, one month after receiving a single dose of MenACWY-CRM conjugate vaccine as compared to the control group is reported.|31 days after MenACWY-CRM injection|Analysis was done on the MITT dataset (Pharyngeal carriage)||Percentages of subjects||95% Confidence Interval|Number
846742|NCT01214837|Primary|Percentage of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following a 4-dose Schedule of Men ACWY Vaccination.|The immune response was assessed in terms of percentage of subjects with hSBA ≥ 1:8 against N. meningitidis serogroups A, C, W and Y following 4 doses of Men ACWY vaccine given to infants at 2, 4, 6 and 12 months of age.|13 months of age|Analysis was done on the Toddler Per Protocol Population (PPS) - all subjects who received all doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to unblinding through 13 month timepoint.||Percentage of subjects||95% Confidence Interval|Number
846729|NCT01214850|Primary|Percentages of Subjects With Carriage of Virulent Sequence Types (ST) of Neisseria Meningitidis Group B, One Month After Completion of rMenB+OMV NZ Vaccination|"Percentages of subjects with carriage of virulent sequence types (ST) of Neisseria meningitidis group B, one month after completion of rMenB+OMV NZ vaccination. The carriage rate of virulent sequence types (ST) of N. meningitidis group B (genogroupable) in subjects, one month after receiving two doses of rMenB+OMV NZ, as compared to the control group, was reported.
Virulent ST types are defined as Clonal Complex multi locus sequence typing (MLST) or ST type being the same compared to history data (Clonal Complexes MLST or ST types found to be virulent and causing diseases) from the years 2006 to 2010."|61 days (31 days after receiving the second injection)|Analysis was done on the modified-intention to treat (MITT) dataset (Pharyngeal carriage), i.e subjects who actually received a study vaccination and provided at least one evaluable swab sample at baseline and after vaccination.||Percentages of subjects||95% Confidence Interval|Number
846730|NCT01214837|Secondary|Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination.||13 months of age|Analysis was done on the Unsolicited Safety Set - All subjects in the Exposed Set with unsolicited adverse event data.||Subjects|||Number
846731|NCT01214837|Secondary|Number Of Subjects Reporting Solicited Local or Systemic Adverse Events.|Safety was assessed as the number of subjects who reported solicited local or systemic adverse events between 6 hours and day 7 after administration of MenACWY with concomitant vaccines vs. concomitant vaccines alone.|Day 1 through Day 7|Analysis was done on Solicited Safety Set - All subjects in the Exposed Set with solicited adverse event data||Subjects|||Number
846732|NCT01214837|Secondary|Percentage Of Subjects Reporting at Least One Severe Systemic Solicited Adverse Event.|Safety was assessed as the percentages of subjects who reported severe solicited systemic adverse events within 30 minutes through day 7 of MenACWY administration with concomitant vaccines vs. concomitant vaccines alone.|Within 7 days|Analysis was done on the Solicited Safety Set - All subjects in the Exposed Set with solicited adverse event data||Percentage of subjects|||Number
846733|NCT01214837|Secondary|Effect of Concomitant Administration of 3 or 4 Doses of MenACWY on Immune Response to PCV-13 Antigens at 13 Months of Age.|Geometric mean concentrations (GMCs) of antibodies against PCV-13 vaccine antigens at 13 months of age following concomitant administration of a 3- or 4-dose series of MenACWY with PCV-13.|13 months of age.|Analysis was done on the Toddler PPS.||µg/mL||95% Confidence Interval|Geometric Mean
846734|NCT01214837|Secondary|Effect of Concomitant Administration of 2 or 3 Doses of MenACWY on Immune Response to PCV-13 Antigens at 7 Months of Age.|Percentage of subjects with IgG concentration ≥ 0.35 μg/mL against pneumococcal conjugate vaccine (PCV-13) antigens at 7 Months of age following concomitant administration of 2 or 3 doses of MenACWY with PCV-13.|7 months of age.|Analysis was done on the Infant PPS.||Percentage of subjects||95% Confidence Interval|Number
846735|NCT01214837|Secondary|Percentage of Subjects With 4-fold Increase in hSBA Titers Against N Meningitis Serogroups A, C, W and Y Between 12 and 13 Months of Age.|The immune response was assessed in terms of percentage of subjects with 4-fold increase in hSBA titers between post and pre toddler dose against N meningitis serogroups A, C, W and Y, 1 month after completing a 3- or 4-dose series of MenACWY.|13 months of age|Analysis was done on the Toddler PPS.||Percentage of subjects||95% Confidence Interval|Number
846736|NCT01214837|Secondary|GMTs at 13 Months of Age After Completion of 3- and 4-Dose Series of MenACWY.|Immune response was assessed in terms of GMTs against N meningitis serogroups A, C, W and Y at 1 month after completion of a 3- and 4- dose series of MenACWY.|13 months of age|Analysis was done on the Toddler PPS.||Titers||95% Confidence Interval|Geometric Mean
846737|NCT01214837|Secondary|Geometric Mean hSBA Titers Following 2 and 3 Infant Doses of MenACWY.|The immune response was assessed in terms of GMTs against N. meningitidis serogroups A, C, W and Y following 2 and 3 infant doses of MenACWY as measured prior to the toddler dose at 12 months of age.|12 months of age|Analysis was done on the Toddler PPS.||Titers||95% Confidence Interval|Geometric Mean
846738|NCT01214837|Secondary|Percentage of Subjects With hSBA ≥1:8 Following 2 and 3 Infant Doses of MenACWY.|Percentage of subjects with hSBA ≥1:8 against N meningitis serogroups A, C, W and Y was assessed following 2 and 3 infant doses of MenACWY as measured prior to the toddler dose at 12 months of age.|12 months of age.|Analysis was done on the Toddler PPS.||Percentage of subjects||95% Confidence Interval|Number
846739|NCT01214837|Secondary|Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age.|Antibody levels were assessed in terms of geometric mean titers (GMTs) against N. meningitidis serogroups A, C, W and Y at baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age.|Baseline(2 months of age), 3 months, 4 months , 5 months and 7 months of age.|Analysis was done on the Infant PPS.||Titers||95% Confidence Interval|Geometric Mean
846740|NCT01214837|Secondary|Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age.|Antibody levels were assessed in terms of percentage of subjects with hSBA ≥ 1:8 against N. meningitidis serogroups A, C, W and Y at baseline (2 months of age) and at 3, 4, 5 and 7 months of age.|Baseline (2 months of age), 3 months, 4 months , 5 months and 7 months of age|Analysis was done on Infant PPS - all subjects who received all doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to unblinding, through the 7 month timepoint.||Percentages of subjects||95% Confidence Interval|Number
846741|NCT01214837|Primary|Percentage of Subjects With hSBA ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 4-Dose and 3-Dose Schedule of Men ACWY Vaccination.|The immune response was assessed in terms of percentage of subjects with hSBA ≥ 1:8 against N. meningitidis serogroups A, C, W and Y following 4 doses of Men ACWY vaccine given to infants at 2, 4,6 and 12 months of age and 3 doses of Men ACWY given to infants at 2, 4 and 12 months of age.|13 months of age|Analysis was done on Toddler PPS.||Percentage of subjects||95% Confidence Interval|Number
847206|NCT00738972|Primary|Left Ventricular Hypertrophy Reduction With Statins in Hypertensive Patients|Left ventricular hypertrophy reduction was to be measured by echocardiography.|6 Month(s)|This study was terminated early and due to sample size it was not possible to perform further statistical analyses.|||||
846745|NCT01179191|Other Pre-specified|Number of Participants With Greater Than or Equal to One Urine Drug Test Results Negative for Expected Opioid|Urine samples collected were screened using immunoassay techniques for the following types of drugs: opioids, barbiturates, benzodiazepines, amphetamines, ecstasy (3, 4-MDMA), cocaine, PCP and marijuana (THC). Quantitative, confirmatory urine drug testing was performed for positive results using gas chromatography or high-pressure liquid chromatography, for the following analytes: morphine, oxycodone, oxymorphone, hydrocodone, hydromorphone, fentanyl, methadone, benzodiazepines, amphetamines, cocaine, THC, PCP, and MDMA.|Baseline, Visit 3 (up to Week 6)|Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. Here, the ‘n’ is signifying those participants who were evaluable for this measure at the specified time point for this arm group.||Participants|||Number
846746|NCT01179191|Other Pre-specified|Number of Participants With Urine Drug Test Results Positive for Illicit Substances|Urine samples collected were screened using immunoassay techniques for following types of drugs:opioids,barbiturates,benzodiazepines,amphetamines,ecstasy(3,4MDMA),cocaine,PCP,marijuana (THC).Quantitative, confirmatory urine drug testing performed for positive results using gas chromatography or high-pressure liquid chromatography for following analytes: morphine,oxycodone,oxymorphone,hydrocodone,hydromorphone,fentanyl,methadone,benzodiazepines,amphetamines,cocaine,THC,PCP,MDMA. Illicit substances were drugs of categories:marijuana (THC) metabolite,cocaine metabolite,PCP,amphetamine.|Baseline, Visit 3 (up to Week 6)|Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. Here, the ‘n’ is signifying those participants who were evaluable for this measure at the specified time point for this arm group.||Participants|||Number
846747|NCT01179191|Other Pre-specified|Number of Participants With Urine Drug Test Results Positive for Unaccounted Opioids|Urine samples collected were screened using immunoassay techniques for the following types of drugs: opioids, barbiturates, benzodiazepines, amphetamines, ecstasy (3, 4-MDMA), cocaine, PCP and marijuana (THC). Quantitative, confirmatory urine drug testing was performed for positive results using gas chromatography or high-pressure liquid chromatography, for the following analytes: morphine, oxycodone, oxymorphone, hydrocodone, hydromorphone, fentanyl, methadone, benzodiazepines, amphetamines, cocaine, THC, PCP, and MDMA.|Visit 3 (up to Week 6)|Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||Participants|||Number
846748|NCT01179191|Other Pre-specified|Number of Participants With Abnormal Urine Drug Test Results|Urine samples collected were screened using immunoassay techniques for the following types of drugs: opioids, barbiturates, benzodiazepines, amphetamines, ecstasy [3, 4-methylenedioxyamphetamine (MDMA)], cocaine, phencyclidine (PCP) and marijuana [tetrahydrocannabinol (THC)]. Quantitative, confirmatory urine drug testing was performed for positive results using gas chromatography or high-pressure liquid chromatography, for the following analytes: morphine, oxycodone, oxymorphone, hydrocodone, hydromorphone, fentanyl, methadone, benzodiazepines, amphetamines, cocaine, THC, PCP, and MDMA.|Baseline, Visit 3 (up to Week 6)|Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. Here, the ‘n’ is signifying those participants who were evaluable for this measure at the specified time point for this arm group.||Participants|||Number
846749|NCT01179191|Other Pre-specified|Number of Participants With Aberrant Behaviors|Current Opioid Misuse Measure (COMM) is a 17-item self-administered test used to monitor aberrant behavior in participants on opioid therapy. Aberrant behaviors assessed using a 5-point scale [0 = ‘never’ and 4 = ‘very often’]. Score range 0-68. Scores greater than or equal to 9 indicated the presence of aberrant behaviors.|Day 5|Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA.||Participants|||Number
846750|NCT01179191|Secondary|Investigator's Level of Satisfaction With the EMBEDA Conversion Guide|The conversion assessment survey is a brief questionnaire using multiple choice options and numeric rating scale (NRS) with specified anchored responses ranging on a scale from 0-10 (0 = very dissatisfied, 5 = neutral, and 10=very satisfied) to assess the Investigator’s level of satisfaction with the EMBEDA Conversion Guide.|Week 6|Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||Units on a Scale||Standard Deviation|Mean
846751|NCT01179191|Secondary|Change From Baseline in Brief Pain Inventory (BPI) at Visit 3 (First Visit After Successful Titration)|BPI is an 11-item self-report questionnaire: consist of 4 questions that assess pain intensity (worst, least, average, relief) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each question answered on a scale range:0-10 (0%-100% for relief), ‘0=No pain/no relief/no interference and 10=Pain as bad as you can imagine/complete relief/ complete interference’.Measure can be scored by item, with lower scores being indicative of less pain or pain interference.|Baseline, Visit 3 (up to Week 6)|Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. The 'n' is signifying those participants who were evaluated for the respective subscale.||Units on a scale||Standard Deviation|Mean
846829|NCT01106534|Primary|Incidence of Composite of All Death, MI and Stroke (Defined as MACE)||12-33 months post-stent|Participants enrolled in the study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.|||||
859174|NCT01002742|Secondary|Overall GVHD-free Survival Post-randomization||Months 6 and 12|||percentage of participants||95% Confidence Interval|Number
859175|NCT01002742|Secondary|Incidence of Topical/Non-absorbable Therapy||Day 56|||participants|||Number
859176|NCT01002742|Secondary|Cumulative Steroid Dose|The cumulative steroid dose for each patient will be calculated by adding the doses (end of each week’s dose) for each of the first four weeks of treatment, divided by the number of days of survival during this interval. The cumulative steroid dose was calculated for all patients per treatment arm and compared.|Days 28 and 56|||mg/kg|||Number
859177|NCT01002742|Secondary|Incidence of Discontinuation of Immune Suppression Without Flare||Day 56, Day 180 and Day 360 post-treatment|No data collected|||||
846752|NCT01179191|Secondary|Percentage of Participants With Rescue Medications Usage During Titration|Rescue pain medications were used for supplemental analgesia for breakthrough pain during titration phase. Morphine sulfate IR tablet (less than 20 percent of the total daily dose of EMBEDA per IR dose), ibuprofen (up to 400 milligram (mg)/dose; not to exceed 1200 mg/day), and acetaminophen (up to 1000 mg/dose, not to exceed 4000 mg/day) were used as rescue medications.|Baseline through Week 6|Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||Percentage of participants|||Number
846753|NCT01179191|Secondary|Number of Titration Steps to Achieve Stable Dose Stratified by Prior Opioid Therapy|A dose was considered to be stable dose if it met all of the following criteria: dose was taken for at least 48 hours; investigator deemed the balance between an acceptable level of analgesia and/or function and tolerance of side effects had been achieved; and rescue medication use less than or equal to 2 doses per day.|Baseline through Week 6|Safety population. Participants were stratified based on prior opioid therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluated for this measure for each of the prior medication received.||titration steps||Standard Deviation|Mean
846754|NCT01179191|Secondary|Number of Titration Steps to Achieve Stable Dose|A dose was considered to be stable dose if it met all of the following criteria: dose was taken for at least 48 hours; investigator deemed the balance between an acceptable level of analgesia and/or function and tolerance of side effects had been achieved; and rescue medication use less than or equal to 2 doses per day.|Baseline through Week 6|Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||titration steps||Standard Deviation|Mean
846755|NCT01179191|Secondary|Duration to Titrate Participants to Stable Dose Stratified by Prior Opioid Therapy|A dose was considered to be stable dose if it met all of the following criteria: dose was taken for at least 48 hours; investigator deemed the balance between an acceptable level of analgesia and/or function and tolerance of side effects had been achieved; and rescue medication use less than or equal to 2 doses per day.|Baseline through Week 6|Safety population. Participants were stratified based on prior opioid therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluated for this measure for each of the prior medication received.||Days||Standard Deviation|Mean
846756|NCT01179191|Secondary|Duration to Titrate Participants to Stable Dose|A dose was considered to be stable dose if it met all of the following criteria: dose was taken for at least 48 hours; investigator deemed the balance between an acceptable level of analgesia and/or function and tolerance of side effects had been achieved; and rescue medication use less than or equal to 2 doses per day.|Baseline through Week 6|Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||Days||Standard Deviation|Mean
846757|NCT01179191|Primary|Percentage of Participants Achieving Stable Dose of EMBEDA Within 6 Weeks Titration Phase Stratified by Prior Opioid Therapy|A dose was considered to be stable dose if it met all of the following criteria: dose was taken for at least 48 hours; investigator deemed the balance between an acceptable level of analgesia and/or function and tolerance of side effects had been achieved; and rescue medication use less than or equal to 2 doses per day.|Baseline through Week 6|Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. Participants were stratified based on prior opioid therapy. The 'n' is signifying those participants who were evaluated for this measure for each of the prior medication received.||Percentage of participants||95% Confidence Interval|Number
846758|NCT01179191|Primary|Percentage of Participants Achieving Stable Dose of EMBEDA Within 6 Weeks Titration Phase|A dose was considered to be stable dose if it met all of the following criteria: dose was taken for at least 48 hours; investigator deemed the balance between an acceptable level of analgesia and/or function and tolerance of side effects had been achieved; and rescue medication use less than or equal to 2 doses per day.|Baseline through Week 6|Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA.||Percentage of participants||95% Confidence Interval|Number
846759|NCT01167452|Primary|Elimination Rate Constants for Sulfamethoxazole and Trimethoprim||24 hours|||hr-1||Full Range|Median
846760|NCT01165840|Primary|Serum Clearance|Serum clearance of dapsone|72 hours|||L/h||Standard Deviation|Mean
846778|NCT01152996|Secondary|Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score|The change between HAM-A score at each assessed visit and HAM-A score at baseline. HAM-A is a 14 item rating scale to quantify anxiety symptomatology severity (i.e., anxious mood, tension, fear, insomnia, etc.) rated on a 5-point scale from 0 (not present) to 4 (severe) with a total score range from 0 to 56. Higher scores indicate greater severity of symptoms.|Baseline and Weeks 4, 24, and 52|Safety set, observed cases (OC)||units on a scale||Standard Deviation|Mean
846909|NCT00996307|Secondary|Antibody Response Based on Baseline Seropositivity|Subgroup analysis based on Subjects with a pre-vaccination HI antibody titer < 1:10 and prevaccination HI antibody titer ≥ 1:10|Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination)|The analysis was done on the subgroup of the per-protocol set (PPS).||Percentages of Subjects||95% Confidence Interval|Number
846819|NCT01112059|Primary|Matrix Metalloprotease-9 (MMP-9) Protein Levels in Sputum|Mean sputum matrix metalloprotease-9 (MMP-9) levels measured at the end of therapy|8 days past baseline|||ng/mg total protein||Standard Deviation|Mean
846820|NCT01112059|Primary|Number of Adverse Events|Examines tolerability and safety with focus on adverse events (AEs) and serious adverse events (SAEs)|1 month from enrollment|||adverse events|||Number
846773|NCT01152996|Secondary|Change From Baseline in SDS Family Life/Home Responsibilities Subscale|The change between the Sheehan Disability family life/home responsibilities subscale score at each assessed visit and family life/home responsibilities subscale score collected at baseline. The SDS is a 3 item rating scale to assess functional impairment (panic, anxiety, phobic and depressive symptoms) over three inter-related domains (work/school, social life, and family life/home responsibilities) rated on an 11 point scale from 0 (not at all) to 10 (extremely). Higher scores indicate greater severity of impairment.|Baseline and Weeks 12, 24, 36, and 52|Safety set, observed cases (OC)||units on a scale||Standard Deviation|Mean
846774|NCT01152996|Secondary|Change From Baseline in SDS Social Life Subscale|The change between the Sheehan Disability social life subscale score at each assessed visit and social life subscale score collected at baseline. The SDS is a 3 item rating scale to assess functional impairment (panic, anxiety, phobic and depressive symptoms) over three inter-related domains (work/school, social life, and family life/home responsibilities) rated on an 11 point scale from 0 (not at all) to 10 (extremely). Higher scores indicate greater severity of impairment.|Baseline and Weeks 12, 24, 36, and 52|Safety set, observed cases (OC)||units on a scale||Standard Deviation|Mean
846775|NCT01152996|Secondary|Change From Baseline in SDS Work/School Subscale|The change between the Sheehan Disability work/school subscale score at each assessed visit and work/school subscale score collected at baseline. The SDS is a 3 item rating scale to assess functional impairment (panic, anxiety, phobic and depressive symptoms) over three inter-related domains (work/school, social life, and family life/home responsibilities) rated on an 11 point scale from 0 (not at all) to 10 (extremely). Higher scores indicate greater severity of impairment.|Baseline and Weeks 12, 24, 36, and 52|Safety set, observed cases (OC)||units on a scale||Standard Deviation|Mean
846776|NCT01152996|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score|The change between the SDS total score at each assessed visit and the total score collected at baseline. The SDS is a 3 item rating scale to assess functional impairment (panic, anxiety, phobic and depressive symptoms) over three inter-related domains (work/school, social life, and family life/home responsibilities) rated on an 11 point scale from 0 (not at all) to 10 (extremely) with a total score range from 0 to 30. Higher scores indicate greater severity of impairment.|Baseline and Weeks 12, 24, 36, and 52|Safety set, observed cases (OC)||units on a scale||Standard Deviation|Mean
846777|NCT01152996|Secondary|Change From Baseline in Clinical Global Impression Scale-Severity of Illness (CGI-S)|"The change between CGI-S score at each assessed visit and CGI-S score at baseline. The CGI-S assesses the clinician’s impression of the subject’s current state of mental illness and consists of one question for the investigator: Considering your total clinical experience with this particular population, how mentally ill is the patient at this time? which is rated on a seven-point scale (1=normal, not ill at all; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=extremely ill). Higher scores indicate greater severity of illness."|Baseline and Weeks 4, 24, and 52|Safety set, observed cases (OC)||units on a scale||Standard Deviation|Mean
846821|NCT01106534|Secondary|Major Bleeding for Treatment Population||12 through 30 months and 12 through 33 months|Participants enrolled in the study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.|||||
846779|NCT01152996|Secondary|Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score|The change between MADRS total score at each assessed visit and MADRS score at baseline. MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (i.e., apparent sadness, reported sadness, inner tension, etc.) rated on a 7-point Likert scale from 0 (normal) to 6 (most abnormal) with a total score range from 0 to 60. Higher scores indicate greater severity of symptoms.|Baseline and Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 36, 44, and 52|Safety set, observed cases (OC)||units on a scale||Standard Deviation|Mean
846780|NCT01152996|Primary|Treatment-Emergent Adverse Events Leading to Study Discontinuation|Treatment-emergent adverse events are adverse events with an onset that occurs after receiving study drug and within 30 days after receiving the last dose of study drug. A TEAE may also be a pre-treatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing.|Over the 52 week period|Safety set||participants|||Number
846781|NCT01152996|Primary|Number of Participants With Serious Treatment-Emergent Adverse Events|Serious treatment-emergent adverse events (serious-TEAE) are adverse events with an onset that occurs after receiving study drug and within 30 days after receiving the last dose of study drug. A serious-TEAE may also be a pretreatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, result in a persistent or significant disability/incapacity or result in a congenital anomaly/birth defect. Other important medical events, based upon appropriate medical judgment, may also be considered serious adverse events if a trial participant's health is at risk and intervention is required to prevent an outcome mentioned.|Over the 52 week period|Safety set||participants|||Number
846782|NCT01152996|Primary|Number of Participants With Treatment-Emergent Adverse Events at a Frequency Threshold of ≥5%|Treatment-emergent adverse events (TEAE) are adverse events with an onset that occurs after receiving study drug and within 30 days after receiving the last dose of study drug. A TEAE may also be a pretreatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing.|Over the 52 week period|Safety set||participants|||Number
846783|NCT01144416|Secondary|Number of Participants Who Cancelled the Cycle Due to a (Serious) Adverse Event|The number of participants who started stimulation but did not undergo embryo transfer due to (S)AEs will be compared between the treatment groups.|Up to time of embryo transfer (maximum of 24 days after start of study drug)|All-Subjects-Treated (AST) Group, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received.||participants|||Number
846784|NCT01144416|Secondary|Number of Participants With Moderate or Severe Ovarian Hyperstimulation Syndrome (OHSS)|"Grade II (moderate OHSS) is characterized by distinct ovarian cysts (ovary size 8-10 cm), accompanied by abdominal pain and tension, nausea, vomiting, diarrhea.
Grade III (severe OHSS) is characterized by enlarged cystic ovaries (ovary size >10 cm), accompanied by ascites and occasionally hydrothorax. Abdominal tension and pain may be severe. Pronounced hydrothorax together with an abdominal cavity filled with cysts and fluid elevating the diaphragm, may cause severe breathing difficulties. Large quantities of fluid inside the cysts and in the peritoneal and pleural cavities cause hemoconcentration and increased blood viscosity. In rare cases, the syndrome may further be complicated by the occurrence of thromboembolic phenomena."|Up to approximately 1 month after oocyte pick-up|All-Subjects-Treated (AST) Group, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received.||participants|||Number
846785|NCT01144416|Secondary|Live Birth Rate|The live-birth rate is the percentage of participants with at least 1 live born infant after an ongoing pregnancy in the controlled ovarian stimulation (COS)treatment cycle relative to the number of participants treated.|Approximately nine months after embryo transfer|Intent-To-Treat Group: all randomized participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the treatment they were randomized to.||Percentage of participants|||Number
846786|NCT01144416|Secondary|Number of Oocytes Retrieved Per Attempt|The number of cumulus oocyte-complexes retrieved was summarized per treatment group and per attempt (= per started COS cycle).|Maximally 21 days after the start of study treatment.|Intent-To-Treat (ITT) Group, defined as all randomized participants who received one or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the treatment they were randomized to. The number of oocytes retrieved were set to zero for participants who did not have oocyte retrieval.||Number of oocytes||Standard Deviation|Mean
846787|NCT01144416|Primary|Percentage of Participants With a Vital Pregnancy|Vital pregnancy was defined as the presence of at least 1 fetus with heart activity at least 35 days (≥5 weeks) after embryo transfer in the controlled ovarian stimulation (COS) treatment cycle|Vital pregnancy will be assessed by ultrasound at least 35 days after embryo transfer (with a timeframe of 35-42 days). Time from start of study treatment to embryo transfer is maximally 24 days.|Intent-To-Treat Group: all randomized participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the treatment they were randomized to. Participants who did not have embryo transfer or who were lost to follow-up before the ultrasound assessment to confirm vital pregnancy were counted as non-pregnant.||percentage of participants|||Number
846793|NCT01131182|Secondary|Proportion of Participants With at Least One Symptomatic or Asymptomatic Hypoglycemic Event|Hypoglycemic event was based on the participant's self-report and/or finger-stick blood glucose level. Symptomatic hypoglycemic symptoms included faintness, headache, confusion, anxiety, sweating, tremor, palpitation, nausea, pallor, dizziness, hunger, and sudden behavioral change.|30 days: first day of Ramadan (August 11) to last day of Ramadan (September 10)|All participants as treated population consisted of all randomized participants who received at least one dose of study treatment and returned at least one completed diary card during the Ramadan period.||Proportion of participants|||Number
846794|NCT01131182|Primary|Proportion of Participants With at Least One Symptomatic Hypoglycemic Event|Symptomatic hypoglycemic event was determined based on the participant's self-reported symptoms including faintness, headache, confusion, anxiety, sweating, tremor, palpitation, nausea, pallor, dizziness, hunger, and sudden behavioral change.|30 days: first day of Ramadan (August 11) to last day of Ramadan (September 10)|All participants as treated population consisted of all randomized participants who received at least one dose of study treatment and returned at least one completed diary card during the Ramadan period.||proportion of participants|||Number
846795|NCT01126424|Primary|Change From Baseline in Cognitive Function Composite Score - Speed of Memory|Cognitive effects were assessed at the end of each treatment period using a computerized assessment system at time points close to the predicted time to attain maximum plasma concentration for solifenacin and oxybutynin. Speed of Memory was calculated from the sum of 4 cognitive function speed tests: numeric and spatial working memory and word and picture recognition. A low score reflects that a person is able to recall a name, a face or any other item fast from the episodic secondary memory; a positive change from baseline reflects impairment compared to baseline.|Assessed at each treatment period baseline visit (the day prior to the first dose of each treatment; Days -1, 42, 84) and at the end of each treatment period (Days 21, 63 and 105). At each visit, tests were performed at 2 and 6 hours post-dose.|The number of participants analyzed represents the Safety Analysis Subset 1 (SAF1), consisting of all randomized patients who took at least one dose of the study medication and who completed the cognitive function tests for at least two treatment periods. The number of participants per arm is consistent for all categories / rows of the data table.||msec||Standard Deviation|Mean
846796|NCT01126424|Primary|Change From Baseline in Cognitive Function Composite Score - Quality of Episodic Secondary Memory|Cognitive effects were assessed at the end of each treatment period using a computerized assessment system at time points close to the predicted time of maximum plasma concentration for solifenacin and oxybutynin. Quality of episodic secondary memory is calculated from the sum of 4 tests: Immediate and delayed word recall, and word and picture recognition, and ranges from -200 to 400. A high score reflects a good ability to store, hold and retrieve information of an episodic nature (i.e. an event or a name) and a negative change from baseline reflects impairment compared to baseline.|Assessed at each treatment period baseline visit (the day prior to the first dose of each treatment; Days -1, 42, 84) and at the end of each treatment period (Days 21, 63 and 105). At each visit, tests were performed at 2 and 6 hours post-dose.|The number of participants analyzed represents the Safety Analysis Subset 1 (SAF1), consisting of all randomized patients who took at least one dose of the study medication and who completed the cognitive function tests for at least two treatment periods. The number of participants per arm is consistent for all categories / rows of the data table.||Scores on a scale||Standard Deviation|Mean
846797|NCT01126424|Primary|Change From Baseline in Cognitive Function Composite Score - Quality of Working Memory|Cognitive effects were assessed at the end of each treatment period using a computerized assessment system at time points close to the predicted time to attain maximum plasma concentration (Tmax) for solifenacin (6 hours) and oxybutynin (2 hours). Quality of working memory is calculated from the sum of two cognitive function sensitivity tests: Numeric Working Memory Sensitivity and Spatial Working Memory Sensitivity, and ranges from -2 to 2. A higher score reflects a good working memory and a negative change from baseline reflects impairment compared to the baseline assessment.|Assessed at each treatment period baseline visit (the day prior to the first dose of each treatment; Days -1, 42, 84) and at the end of each treatment period (Days 21, 63 and 105). At each visit, tests were performed at 2 and 6 hours post-dose.|The number of participants analyzed represents the Safety Analysis Subset 1 (SAF1), consisting of all randomized patients who took at least one dose of the study medication and who completed the cognitive function tests for at least two treatment periods. The number of participants per arm is consistent for all categories / rows of the data table.||Scores on a scale||Standard Deviation|Mean
846798|NCT01126424|Primary|Change From Baseline in Cognitive Function Composite Score – Continuity of Attention|Cognitive effects were assessed using a computerized assessment system at time points close to the predicted time of maximum plasma concentration for solifenacin and oxybutynin. For continuity of attention, the number of correct responses (out of 50) for choice reaction time was added to the total number of targets correctly identified (out of 45) digit vigilance minus the number of false alarms (total score of -45 to 95). A high score reflects someone able to keep his/her mind on a single task for a prolonged period. A negative change from baseline reflects impairment compared to baseline.|Assessed at each treatment period baseline visit (the day prior to the first dose of each treatment; Days -1, 42, 84) and at the end of each treatment period (Days 21, 63 and 105). At each visit, tests were performed at 2 and 6 hours post-dose.|The number of participants analyzed represents the Safety Analysis Subset 1 (SAF1), consisting of all randomized patients who took at least one dose of the study medication and who completed the cognitive function tests for at least two treatment periods. The number of participants per arm is consistent for all categories / rows of the data table.||Scores on a scale||Standard Deviation|Mean
846799|NCT01126424|Secondary|Change From Baseline in Postural Stability Test|"The postural stability test measures the ability to stand upright without moving, and was assessed at the end of each treatment period using a computerized assessment system at time points close to the predicted time to attain maximum plasma concentration for solifenacin and oxybutynin. Using apparatus modeled on the Wright Ataxia-meter, a cord from the meter is attached to the patient who is required to stand as still as possible with feet apart and eyes closed for 1 minute.
The amount of sway is expressed as the total angular movement, summed regardless of sign, in the antero-posterior plane and calibrated in units of one-third degree of angle of sway. Wright (1971) described a range of 20-30 units as a normal range for adults with eyes wide open, increasing by 50 to 100% with eyes shut."|Assessed at each treatment period baseline visit (the day prior to the first dose of each treatment; Days -1, 42, 84) and at the end of each treatment period (Days 21, 63 and 105). At each visit, tests were performed at 2 and 6 hours post-dose.|The number of participants analyzed represents the Safety Analysis Subset 1 (SAF1), consisting of all randomized patients who took at least one dose of the study medication and who completed the cognitive function tests for at least two treatment periods. The number of participants per arm is consistent for all categories / rows of the data table.||1/3 degree of angle of sway||Standard Deviation|Mean
846800|NCT01126424|Primary|Change From Baseline in Cognitive Function Composite Score - Power of Attention|Cognitive effects were assessed at the end of each treatment period using a computerized assessment system at time points close to the predicted time to attain maximum plasma concentration (Tmax) for solifenacin (6 hours) and oxybutynin (2 hours). Power of attention is calculated from the sum of three cognitive function speed tests: Simple Reaction Time, Choice Reaction Time and the Speed of Detections in Digit Vigilance task. A low score reflects a fast reaction time and a high intensity of concentration. A positive change from baseline reflects impairment compared to the baseline assessment.|Assessed at each treatment period baseline visit (the day prior to the first dose of each treatment; Days -1, 42, 84) and at the end of each treatment period (Days 21, 63 and 105). At each visit, tests were performed at 2 and 6 hours post-dose.|The number of participants analyzed represents the Safety Analysis Subset 1 (SAF1), consisting of all randomized patients who took at least one dose of the study medication and who completed the cognitive function tests for at least two treatment periods. The number of participants per arm is consistent for all categories / rows of the data table.||msec||Standard Deviation|Mean
846803|NCT01116427|Secondary|Mean Change in the MSFC in Extension Phase|The Multiple Sclerosis Functional Composite (MSFC) is a three-part, standardized, quantitative assessment instrument to measure severity of multiple sclerosis. The MSFC combines three component measures to create a composite measure. The three component measures of the MSFC include the 1) Time 25-foot Walk (a measure of lower extremity function), 2) 9-hole Peg Test (a measure of upper extremity function), and 3) Paced Auditory Serial Addition Test (a measure of cognitive function). Mean change in MSFC scores from Week 24 to Week 52 were assessed. Scores from all three components are combined then are converted into a Z-score for analyses, with a range from -1 to 1. A positive score indicates improvement in the severity of multiple sclerosis symptoms while negative scores indicate decline in multiple sclerosis symptoms.|Week 24 to Week 52|Intent-to-treat in Extension Phase who Completed the MSFC at Week 52||Scores on a scale||Standard Deviation|Mean
846804|NCT01116427|Secondary|Annualized Relapse in Extension Phase|The rate of multiple sclerosis relapse by year. Annualized relapse rate is calculated by dividing the total number of relapse events in the extension and follow-up phases in each treatment group by the total number of days participants participated in the study during the extension and follow-up phases. This number is then multiplied by 365.25 to get an annualized rate.|Week 24 to Week 64|Intent-to-treat in Extension Phase||Relapse Rate by Year|||Number
846805|NCT01116427|Secondary|Number of Participants Progressing on the EDSS Scale by at Least 1 Point|The Expanded Disability Status Scale (EDSS) is an assessment for severity of multiple sclerosis. The EDSS an ordinal clinical rating scale ranging from 0 (normal neurological examination) to 10 (death due to multiple sclerosis) in half-point increments. Extension baseline EDSS score was the most recent non-missing value on or before Week 28. Only participants who scored between a 0 and a 5 at baseline were analyzed for this outcome measure. EDSS progression is defined as an increase of at least 1 point on the EDSS compared to baseline if the baseline was greater than 1.0, or 1.5 points on EDSS if baseline was less than or equal to 1.0, which persisted for a minimum of 12 weeks or was found on three consecutive EDSS assessments starting at Visit 3 (Wk 8).|Week 24 to Week 64|Intent-to-treat in Extension Phase||participants|||Number
847207|NCT00737672|Secondary|Procedural Success|Participants were considered to have Procedural Success if they achieved both anatomic success and clinical success.|Following Index Procedure|||Participants|||Number
846806|NCT01116427|Secondary|Percent Brain Volume Change Between 24 Weeks and 52 Weeks|Percent Brain Volume Change is a measure of brain atrophy. Brain volume was calculated from a MRI scan at Week 24 and a MRI scan at Week 25 then the percent change from Week 24 to Week 52 was calculated. A negative change score means volume decreased. A decrease in volume indicates progression of multiple sclerosis severity.|Week 24 to Week 52|Intent-to-treat in Extension Phase who had an MRI at Week 52 with data to contribute to brain volume measurements||Percent change||Standard Deviation|Mean
846807|NCT01116427|Secondary|Lesion Volume Accumulation on T2-Weighted MRI Scans Between 24 Weeks and 52 Weeks|Difference in total volume of all T2 lesions detected at Week 52 MRI scan compared to Week 24 MRI scan. A T2 lesion is defined as an abnormal, hyperintense white-matter area visible on T2 weighted images. A higher score indicates more severe multiple sclerosis.|Week 24 to Week 52|Intent-to-treat in Extension Phase who had an MRI at Week 52||cm^3||Standard Deviation|Mean
846808|NCT01116427|Secondary|Mean Number of New Inflammatory MRI Lesions Per Scan During the Extension Phase|The mean number of new inflammatory MRI lesions obtained on scans at Weeks 36 and 52, adjusted for differences between subjects before treatment by subtracting the number of new inflammatory lesions observed from the week 24 MRI scan. An inflammatory lesion is defined as a gadolinium (Gd)-enhancing lesion that shows hyperintensity on postcontrast but no hyperintensity on noncontrast T1 images. A new inflammatory lesion is one that was not present on the previously scheduled MRI scan. If the previously scheduled MRI scan was missing, the scan was compared to the last available MRI.|Weeks 36 and 52|Intent-to-treat in Extension Phase||New Lesions||Standard Deviation|Mean
846809|NCT01116427|Secondary|Mean Change in the MSFC Over 24 Weeks of Treatment|The Multiple Sclerosis Functional Composite (MSFC) is a three-part, standardized, quantitative assessment instrument to measure severity of multiple sclerosis. The MSFC combines three component measures to create a composite measure. The three component measures of the MSFC include the 1) Time 25-foot Walk (a measure of lower extremity function), 2) 9-hole Peg Test (a measure of upper extremity function), and 3) Paced Auditory Serial Addition Test (a measure of cognitive function). Mean change in MSFC scores from baseline to Week 24 were assessed. Scores from all three components are combined then are converted into a Z-score for analyses, with a range from -1 to 1. A positive score indicates improvement in the severity of multiple sclerosis symptoms while negative scores indicate decline in multiple sclerosis symptoms.|Week -1 to Week 24|Intent-to-treat||Scores on a scale||Standard Deviation|Mean
846810|NCT01116427|Secondary|Annualized Relapse Rate|The rate of multiple sclerosis relapse by year. Annualized relapse rate is calculated by dividing the total number of relapse events in the core phase in each treatment group by the total number of days participants participated in the study during the core phase. This number is then multiplied by 365.25 to get an annualized rate.|Week -1 to Week 24|Intent-to-treat||Relapse Rate by Year|||Number
846811|NCT01116427|Secondary|Number of Participants Progressing on the EDSS Scale by at Least 1 Point|The Expanded Disability Status Scale (EDSS) is an assessment for severity of multiple sclerosis. The EDSS an ordinal clinical rating scale ranging from 0 (normal neurological examination) to 10 (death due to multiple sclerosis) in half-point increments. Baseline EDSS score was the lowest score observed at either visit -2 (Wk -5) or visit -1 (Wk -1). EDSS progression is defined as an increase of at least 1 point on the EDSS compared to baseline if the baseline was greater than 1.0, or 1.5 points on EDSS if baseline was less than or equal to 1.0, which persisted for a minimum of 12 weeks or was found on three consecutive EDSS assessments starting at Visit 3 (Wk 8).|Week -1 to Week 24|Intent-to-treat||participants|||Number
846812|NCT01116427|Secondary|Mean Number of New Inflammatory Lesions in 8-week Intervals|The mean number of new inflammatory MRI lesions obtained on scans every 8 weeks from Week 8 to Week 24. An inflammatory lesion is defined as a gadolinium (Gd)-enhancing lesion that shows hyperintensity on postcontrast but no hyperintensity on noncontrast T1 images. A new inflammatory lesion is one that was not present on the previously scheduled MRI scan. If the previously scheduled MRI scan was missing, the scan was compared to the last available MRI.|Week 8 to Week 24|Intent-to-treat||New Lesions||Standard Deviation|Mean
846813|NCT01116427|Secondary|Percent Brain Volume Change|Percent Brain Volume Change is a measure of brain atrophy. Brain volume was calculated from a MRI scan at Week -1 and a MRI scan at Week 24 then the percent change from Week -1 to Week 24 was calculated. A negative change score means volume decreased. A decrease in volume indicates progression of multiple sclerosis severity.|Week -1 to Week 24|Intent-to-treat population that did not terminate study prior to Week 24 and had MRI scans at both Week -1 and Week 24||percent change||Standard Deviation|Mean
846814|NCT01116427|Secondary|Lesion Volume Accumulation on T2-weighted MRI Scans Over 24 Weeks|Difference in total volume of all T2 lesions detected at Week 24 MRI scan compared to Week -1 MRI scan. A T2 lesion is defined as an abnormal, hyperintense white-matter area visible on T2 weighted images. A higher score indicates more severe multiple sclerosis.|Week -1 to Week 24|Intent-to-treat population that did not terminate study prior to Week 24||cm^3||Standard Deviation|Mean
846815|NCT01116427|Secondary|Absolute Number of New Inflammatory MRI Lesions on Monthly Scans|The absolute number of new inflammatory MRI lesions obtained on scans every 4 weeks from Week 8 to Week 24. An inflammatory lesion is defined as a gadolinium (Gd)-enhancing lesion that shows hyperintensity on postcontrast but no hyperintensity on noncontrast T1 images. A new inflammatory lesion is one that was not present on the previously scheduled MRI scan. If the previously scheduled MRI scan was missing, the scan was compared to the last available MRI.|Weeks 4-24|Intent-to-treat||New Lesions||Standard Deviation|Mean
846816|NCT01116427|Primary|Mean Number of New Inflammatory MRI Lesions Per Monthly Scans|The mean number of new inflammatory MRI lesions obtained on scans every 4 weeks from Week 8 to Week 24, adjusted for differences between subjects before treatment by subtracting the number of new inflammatory lesions observed from the week -1 MRI scan . An inflammatory lesion is defined as a gadolinium (Gd)-enhancing lesion that shows hyperintensity on postcontrast but no hyperintensity on noncontrast T1 images. A new inflammatory lesion is one that was not present on the previously scheduled MRI scan. If the previously scheduled MRI scan was missing, the scan was compared to the last available MRI.|Weeks 8-24|Intent-to-treat||New Lesions||Standard Deviation|Mean
846817|NCT01112059|Secondary|Mean Change in Pulmonary Function Over Treatment Duration|Observe change in FEV1% predicted from beginning to end of study|Baseline to end of inpatient clinical exacerbation (average 14 days)|||Percentage of predicted FEV1||Standard Deviation|Mean
846818|NCT01112059|Secondary|Mean Sputum Matrix Metalloprotease-9 (MMP-9) Activity End of Treatment|Measurement of endogenous active matrix metalloprotease-9 (MMP-9) in the sputum|8 days|||ng/mg total protein||Standard Deviation|Mean
846830|NCT01093534|Secondary|Percentage of Participants With Improvement or Deterioration in Patient Perception of Bladder Condition (PPBC)|"The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'.
Improvement: ≥ 1 point improvement compared to Baseline; Major Improvement: ≥ 2 point improvement compared to Baseline; Deterioration: ≥ 1 point deterioration compared to Baseline."|Baseline and Week 12|Full Analysis Set Bladder Wall Thickness (FAS_BWT) participants with available data; LOCF was used.||percentage of participants|||Number
846831|NCT01093534|Secondary|Change From Baseline to Week 12 in Total Urinary Nerve Growth Factor Normalized by Urine Creatinine|Total (acidified) urinary nerve growth factor (uNGF) and creatinine (Cr) were measured from urine samples by the central laboratories. Total uNGF/Cr was derived by dividing total uNGF concentrations [pg/mL] by the urine creatinine concentrations (µmol/mL) from the same participant.|Baseline and Week 12|Full Analysis Set urinary Nerve Growth Factor subset (FAS_uNGF0) participants with available data; LOCF was used.||pg/µmol||Standard Deviation|Mean
846832|NCT01093534|Secondary|Change From Baseline to Week 12 in Brain Derived Neurotrophic Factor Normalized by Urine Creatinine (uBDNF/Cr)|Brain derived neurotrophic factor (uBDNF) and creatinine (Cr) were measured from urine samples by the central laboratories. uBDNF/Cr was derived by dividing uBDNF concentrations [pg/mL] by the urine creatinine concentrations (µmol/mL) from the same participant.|Baseline and Week 12|Full Analysis Set urinary Brain Derived Neurotrophic Factor (FAS_uBDNF); LOCF was used.||pg/µmol||Standard Deviation|Mean
846833|NCT01093534|Secondary|Change From Baseline in Health-Related Quality of Life (HRQL)|"Health-related quality of life was assessed by the Overactive Bladder Symptom and Health-Related Quality of Life Questionnaire (OAB-q). The OAB-q is a patient-administered instrument comprising of an 8-item symptom bother scale (see previous outcome measure) and 25 HRQL items comprising 4 subscales (concern, coping, social interaction and sleep) and a total HRQL score. Participants were asked how their overall bladder symptoms had affected their life in the past 4 weeks. Each of the 25 HRQL questions has a 6-point Likert scale response ranging from ‘none of the time’ (1) to ‘all of the time’ (6).
The HRQL subscale scores were calculated by summing the responses of the items within each subscale.The HRQL total score was calculated by adding the 4 HRQL subscale scores,. All scores were transformed to a scale from 0 to 100 where higher scores indicate better quality of life. A positive change from Baseline in HRQL score indicates improvement."|Baseline and Week 12|Full Analysis Set Bladder Wall Thickness (FAS_BWT) participants with available data; LOCF was used.||units on a scale||Standard Deviation|Mean
846834|NCT01093534|Secondary|Change From Baseline in Symptom Bother Score|"Overactive bladder symptoms were assessed using the symptom bother scale of the Overactive Bladder Symptom and Health-Related Quality of Life Questionnaire (OAB-q). The OAB-q is a patient-administered instrument comprising an 8-item symptom bother scale and 25 health-related quality of life items (see next outcome measure). In the symptom bother scale participants were asked how much they had been bothered by selected bladder symptoms during the past 4 weeks. Each question has a 6-point Likert scale response ranging from 'not at all' (1) to 'a very great deal' (6).
The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from Baseline in symptom bother score indicates improvement."|Baseline and Week 12|Full Analysis Set Bladder Wall Thickness (FAS_BWT) participants with available data; LOCF was used.||units on a scale||Standard Deviation|Mean
846835|NCT01093534|Secondary|Change From Baseline in EuroQoL 5-Dimension Questionnaire Visual Analog Scale|"The participants’ quality of life was assessed using the EuroQoL 5 Dimension Questionnaire (EQ-5D) visual analog scale (VAS).
Health status is completed by the participant indicating their own health state today by drawing a line on a vertical scale from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (=0) and 'Best imaginable health state' (=100). On the EQ-5D VAS, a positive change from Baseline indicates improvement."|Baseline and Week 12|Full Analysis Set Bladder Wall Thickness (FAS_BWT) participants with available data; LOCF was used.||units on a scale||Standard Deviation|Mean
846836|NCT01093534|Secondary|Percentage of Participants With Improvement and Worsening on the 5 Dimensions of the EQ-5D|"The participants’ quality of life was assessed using the EuroQoL 5 Dimension Questionnaire (EQ-5D). The EQ-5D is a standardized instrument for use as a measure of health outcome and is based on the following 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. For each dimension participants were asked to select the statement which best described their health that day, from level 1 (indicating no problems) to 3 (indicating extreme problems/unable to perform).
Improvement was defined as a change from a state of being unable to perform or extreme problems at Baseline to no problems or to some or moderate problems at Week 12, and from some or moderate problems to no problems.
Worsening was defined as a change from no problems at Baseline to some or moderate problems or to a state of being unable to perform or extreme problems at Week 12, and from some or moderate problems to a state of being unable to perform or extreme problems."|Baseline and Week 12|Full Analysis Set Bladder Wall Thickness (FAS_BWT) participants with available data.||percentage of participants|||Number
846837|NCT01093534|Secondary|Change From Baseline in Patient Assessment of Treatment Satisfaction|The treatment satisfaction visual analog scale (TS_VAS) asks patients to rate their satisfaction with treatment by placing a vertical mark on a 100 mm line where the endpoints are labeled ‘No, not at all’ on the left (score = 0) to ‘Yes, completely satisfied’ on the right (score = 100). A positive change from Baseline indicates improvement.|Baseline and Week 12|Full Analysis Set Bladder Wall Thickness (FAS_BWT) participants with available data; LOCF was used.||units on a scale||Standard Deviation|Mean
846838|NCT01093534|Secondary|Change From Baseline in Patient Assessment of Urgency Bother|"The participants’ perception and impression of bother associated with their condition were assessed using the Urgency Bother-Visual Analog Scale (UB-VAS). The participant was asked to place a vertical mark on a 100 mm line to indicate how much bother has urgency been for them in the past week, whereby ‘no bother at all’ is represented on the left end (score = 0) and ‘worst possible bother’ (score = 100) at the right end of the line.
A negative change from Baseline indicates improvement."|Baseline and Week 12|Full Analysis Set Bladder Wall Thickness (FAS_BWT) participants with available data; LOCF was used.||units on a scale||Standard Deviation|Mean
847208|NCT00737672|Secondary|Anatomic Success|Less than 30 percent residual stenosis following study treatment (Index Procedure).|Index Procedure|||Participants|||Number
846839|NCT01093534|Secondary|Change From Baseline in Patient Perception of Bladder Condition (PPBC)|The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems’; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. A negative change from Baseline score indicates improvement.|Baseline and Week 12|Full Analysis Set Bladder Wall Thickness (FAS_BWT) participants with available data; LOCF was used.||units on a scale||Standard Deviation|Mean
846840|NCT01093534|Secondary|Change From Baseline to Week 12 in Total Urgency Score|"The intensity of urgency of each micturition (urination) and incontinence episode (any involuntary leakage of urine) was recorded by the participant in an electronic diary according to the Patient Perception of Intensity of Urgency Scale (PPIUS) as follows: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet.
The total urgency score was calculated by adding all PPIUS scores over a 3-day period prior to the Baseline and Week 12 visits for each participant."|Baseline and Week 12|Full Analysis Set Bladder Wall Thickness (FAS_BWT) participants with available data; LOCF was used.||units on a scale||Standard Deviation|Mean
846841|NCT01093534|Secondary|Change From Baseline to Week 12 in Mean Level of Urgency|"The intensity of urgency of each micturition (urination) and incontinence episode (any involuntary leakage of urine) was recorded by the participant in an electronic diary according to the Patient Perception of Intensity of Urgency Scale (PPIUS) as follows: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet.
The mean level of urgency was calculated by adding the PPIUS grade for all events (micturition or incontinence) and dividing by the number of episodes recorded in the diary over 3 days prior to the Baseline and Week 12 visits."|Baseline and Week 12|Full Analysis Set Bladder Wall Thickness (FAS_BWT) participants with available data; LOCF was used.||units on a scale||Standard Deviation|Mean
846842|NCT01093534|Secondary|Change From Baseline in Mean Number of Urgency Incontinence Episodes With PPIUS Grade 4 Per 24 Hours|"An urgency incontinence episode is defined as any incontinence episode classified by the participant as a grade 4 on the Patient Perception of Intensity of Urgency Scale (PPIUS) as follows: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet.
The average number of grade 4 urgency incontinence episodes per 24 hours was calculated from the number of urgency incontinence episodes recorded by the participant in an electronic diary for 3 days before the Baseline and Week 12 clinic visits."|Baseline and Week 12|Full analysis set participants with grade 4 urgency incontinence events at Baseline and with available data; LOCF was used.||urgency incontinence episodes||Standard Deviation|Mean
846843|NCT01093534|Secondary|Change From Baseline in Mean Number of Urgency Incontinence Episodes With PPIUS Grade 3 or 4 Per 24 Hours|"An urgency incontinence episode is defined as any incontinence episode classified by the participant as a grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale (PPIUS) as follows: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet.
The average number of grade 3 or 4 urgency incontinence episodes per 24 hours was calculated from the number of urgency incontinence episodes recorded by the participant in an electronic diary for 3 days before the Baseline and Week 12 clinic visits."|Baseline and Week 12|Full analysis set participants with grade 3 or 4 urgency incontinence events at Baseline and with available data; LOCF was used.||urgency incontinence episodes||Standard Deviation|Mean
846844|NCT01093534|Secondary|Change From Baseline to Week 12 in Mean Number of Incontinence Episodes Per 24 Hours|The average number of incontinence episodes (any involuntary leakage of urine) per 24 hours was calculated from the number of incontinence episodes recorded by the participant in an electronic diary for 3 days before the Baseline and Week 12 clinic visits.|Baseline and Week 12|Full analysis set participants with incontinence events at Baseline and with available data; LOCF was used.||incontinence episodes||Standard Deviation|Mean
846845|NCT01093534|Secondary|Change From Baseline to Week 12 in Mean Number of Urgency Micturitions Per 24 Hours|"An urgency micturition is defined as any micturition classified by the participant as a grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale (PPIUS) as follows: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet.
The average number of urgency micturitions per 24 hours was derived from the number of urgency micturitions recorded by the participant in an electronic diary for 3 days before the Baseline and Week 12 clinic visits."|Baseline and Week 12|Full Analysis Set participants with urgency micturitions at Baseline and with available data; LOCF was used.||urgency micturitions||Standard Deviation|Mean
846846|NCT01093534|Secondary|Change From Baseline to Week 12 in Mean Number of Micturitions Per 24 Hours|The average number of micturitions (urinations) per 24 hours was derived from the number of micturitions recorded by the participant in an electronic diary for 3 days before the Baseline and Week 12 clinic visits.|Baseline and Week 12|Full Analysis Set Bladder Wall Thickness (FAS_BWT) participants with available data; LOCF was used.||micturitions||Standard Deviation|Mean
846847|NCT01093534|Secondary|Change From Baseline to Week 12 in Mean Number of Urgency Events Per 24 Hours|"The intensity of urgency of each micturition (urination) and incontinence episode (any involuntary leakage of urine) was recorded by the participant in an electronic diary according to the Patient Perception of Intensity of Urgency Scale (PPIUS) as follows: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet.
An urgency event is defined as any micturition or incontinence episode classified by the participant as a grade 3 or 4 on the PPIUS scale. The average number of urgency events per day is derived from the diary data completed by participants on the 3 days prior to the Baseline and Week 12 visits."|12 weeks|Full analysis set participants with events at Baseline and with available data; LOCF was used.||urgency events||Standard Deviation|Mean
847120|NCT00799617|Secondary|Bone Trial - Volumetric Bone Mineral Density (BMD) of Hip Whole Bone by Quantitative Computed Tomography (QCT)|Hip whole bone as measured by QCT, mg/cm3 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)|1 year (baseline to month 12)|||percentage of change||95% Confidence Interval|Mean
846848|NCT01093534|Secondary|Change From Baseline to Week 12 in Mean Number of Events (Micturitions Plus Incontinence Episodes) Per 24 Hours|The average number of micturitions (urinations) and incontinence episodes (any involuntary leakage of urine) per day was derived from the number of events recorded by the participant in an electronic diary for 3 days before the Baseline and Week 12 clinic visits.|Baseline and Week 12|Full Analysis Set Bladder Wall Thickness (FAS_BWT) participants with available data; LOCF was used.||events||Standard Deviation|Mean
846849|NCT01093534|Secondary|Change From Baseline to Week 6 and Week 12 in Neutralized Urinary Nerve Growth Factor Normalized by Urine Creatinine|Free (neutralized) urinary nerve growth factor (uNGF) and creatinine (Cr) were measured from urine samples by the central laboratories. Free (neutralized) uNGF/Cr was derived by dividing free (neutralized) uNGF concentrations [pg/mL] by the urine creatinine concentrations (µmol/mL) from the same participant.|Baseline, Week 6 and Week 12|Full Analysis Set urinary Nerve Growth Factor subset (FAS_uNGF0) participants with available data at each time point (indicated by n).||pg/µmol||Standard Deviation|Mean
846850|NCT01093534|Secondary|Change From Baseline to Week 6 and Week 12 in Bladder Wall Thickness|Bladder wall thickness (BWT) measurements were obtained using transvaginal ultrasound. The BWT was derived as one mean value per image pooled over measurements of 3 locations (anterior wall, dome and trigone), and performed by 2 central readers and 1 adjudicator.|Baseline, Week 6 and Week 12|Full Analysis Set Bladder Wall Thickness (FAS_BWT) participants with available data at each time point (indicated by n).||mm||Standard Deviation|Mean
846851|NCT01093534|Secondary|Brain Derived Neurotrophic Factor Normalized by Urine Creatinine (uBDNF/Cr) at Week 12|Brain derived neurotrophic factor (uBDNF) and creatinine (Cr) were measured from urine samples by the central laboratories. uBDNF/Cr was derived by dividing uBDNF concentrations [pg/mL] by the urine creatinine concentrations (µmol/mL) from the same participant.|Week 12|Full Analysis Set urinary Brain Derived Neurotrophic Factor (FAS_uBDNF): all randomized participants who received at least 1 dose of randomized study medication, who had given consent for additional analysis and who had an uBDNF/Cr measurement at baseline and on at least 1 visit thereafter. LOCF was used.||pg/µmol||Standard Deviation|Mean
846852|NCT01093534|Secondary|Total Urinary Nerve Growth Factor Normalized by Urine Creatinine at Week 12|Total (acidified) urinary nerve growth factor (uNGF) and creatinine (Cr) were measured from urine samples by the central laboratories. Total uNGF/Cr was derived by dividing total uNGF concentrations [pg/mL] by the urine creatinine concentrations (µmol/mL) from the same participant.|Week 12|Full Analysis Set urinary Nerve Growth Factor subset (FAS_uNGF0) participants with available data; LOCF was used.||pg/µmol||Standard Deviation|Mean
846853|NCT01093534|Primary|Neutralized Urinary Nerve Growth Factor Normalized by Urine Creatinine at Week 12|Free (neutralized) urinary nerve growth factor (uNGF) and creatinine (Cr) were measured from urine samples by the central laboratories. Free (neutralized) uNGF/Cr was derived by dividing free (neutralized) uNGF concentrations [pg/mL] by the urine creatinine concentrations (µmol/mL) from the same participant.|Week 12|Full Analysis Set urinary Nerve Growth Factor subset (FAS_uNGF0): all randomized participants who received at least 1 dose of randomized study medication and who had an uNGF/Cr measurement at Baseline and on at least 1 visit thereafter, excluding participants with Baseline uNGF below or equal to the laboratory quantification limit. LOCF was used.||pg/µmol||Standard Deviation|Mean
846854|NCT01093534|Primary|Change From Baseline to Week 12 in Bladder Wall Thickness|Bladder wall thickness (BWT) measurements were obtained using transvaginal ultrasound. The BWT was derived as one mean value per image pooled over measurements of 3 locations (anterior wall, dome and trigone), and performed by 2 central readers and 1 adjudicator.|Baseline and Week 12|Full Analysis Set Bladder Wall Thickness (FAS_BWT): all randomized participants who received at least 1 dose of randomized study medication and who had a mean BWT measurement at Baseline. Analysis includes participants with available data; Last observation carried forward (LOCF) of post-baseline data was used for imputation of missing values.||mm||Standard Deviation|Mean
846855|NCT01090427|Secondary|The Percentage of Participants With CDLQI Scores of 0 or 1 at Week 12 for Randomized Participants With a Baseline CDLQI Score > 1||Week 12|Efficacy evaluable subjects defined as the subset of all randomized participants with evaluable outcome measurements. In addition, this analysis was limited to participants with a CDLQI of 0 or 1 at baseline.||Percentage of participants|||Number
846856|NCT01090427|Secondary|The Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Total Scale Score, Psychosocial Health Summary Score, and Physical Health Summary Score at Week 12|The PedsQL is a general health-related quality of life measure developed for use in children and adolescent populations. The Generic Core Scale contains 23 items and is comprised of 4 domains: physical, social, emotional, and school functioning. Each domain can be scored independently. Additionally, a Psychosocial Health and Physical Health Summary Score can be calculated as well as a total score. The measure distinguishes between healthy children and children with acute and chronic health conditions and disease severity within a chronic health condition. The measure is applicable for healthy school and community populations, as well as with pediatric populations with acute and chronic health conditions and has versions for both parent and teen report. Scores range from 0 to 100, and higher scores indicate better health related quality of life.|Week 12|Efficacy evaluable subjects defined as the subset of all randomized participants with evaluable outcome measurements available.||Scores on a scale||Standard Deviation|Mean
846857|NCT01090427|Secondary|The Percentage of Participants Who Were PASI 50 Responders and the Percentage of Participants With a PASI Score of 0 at Week 12|The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). The table below shows the percentage of participants in each treatment group who were PASI 50 responders at Week 12 defined as participants who achieved a greater than or equal to (>=) 50% improvement in PASI score from baseline as well as the percentage of participants with a PASI score of 0.|Week 12|Efficacy evaluable subjects defined as the subset of all randomized participants with evaluable outcome measurements.||Percentage of participants|||Number
846910|NCT00996307|Secondary|Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010|Subgroup analysis based on receipt of recent seasonal vaccination. Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines.|Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination)|The analysis was done on the subgroup on the per-protocol set (PPS).||Titers||95% Confidence Interval|Geometric Mean
846858|NCT01090427|Secondary|The Percentage of Participants Achieving a Physician's Global Assessment (PGA) Score of Cleared (0) and PGA Score of Mild or Better (<=2) at Week 12|The PGA documents the physician’s assessment of the participant’s psoriasis status according to the following categories: induration, scaling, and erythema. The participant's psoriasis is assessed as 5-point scale as follows: cleared (0), minimal (1), mild (2), moderate (3), or severe (4); higher score indicates worse disease. The table below shows the percentage of participants who achieved a PGA score of 0 and the percentage of participants who achieved a PGA score of 0, 1, or 2 at Week 12 in each treatment group.|Week 12|Efficacy evaluable subjects defined as the subset of all randomized participants with evaluable outcome measurements.||Percentage of participants|||Number
846859|NCT01090427|Secondary|The Percentage of Participants Achieving a Psoriasis Area and Severity Index (PASI) 90 Response at Week 12 Compared Between the Placebo Group and the Ustekinumab Treatment Groups|The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 to 72, with higher scores indicating worse disease. The table below shows the percentage of participants who achieved a PASI 90 response defined as achieving a greater than or equal to (≥) 90% improvement in PASI score from baseline.|Week 12|The analysis of the PASI 90 response at Week 12 was performed using the all randomized subjects analysis set defined as the population of all participants who were randomized to any treatment group.||Percentage of Participants|||Number
846860|NCT01090427|Secondary|Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score at Week 12 Compared Between the Placebo Group and the Ustekinumab Treatment Groups|The CDLQI is a dermatology-specific quality of life instrument designed to assess the impact of the disease on a child’s quality of life. The CDLQI, a 10-item questionnaire has 4 items response options and a recall period of 1 week. In addition to evaluating overall quality of life, the CDLQI can be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, leisure, School or holidays, personal relationships, sleep, and treatment. The CDLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0; the higher the score, the greater impairment in quality of life. The table below shows the mean change in CDLQI score from baseline at Week 12 for each treatment group.|Baseline; Week 12|Evaluable participants for CDLQI are the subsets of all randomized participants with evaluable outcome measurements.||Scores on a scale||Standard Deviation|Mean
846861|NCT01090427|Secondary|The Percentage of Participants Achieving a Psoriasis Area and Severity Index (PASI) 75 Response at Week 12|The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 to 72, with higher scores indicating worse disease. A PASI 75 response is defined as a equal to or greater than (=>) 75% improvement in PASI score from baseline. The table below shows the percentage of participants who achieved a PASI 75 response at Week 12 in each treatment group.|Week 12|The analysis of the PASI 75 response at Week 12 was performed using the all randomized subjects analysis set defined as the population of all participants who were randomized to any treatment group.||Percentage of Participants|||Number
846862|NCT01090427|Primary|The Percentage of Participants Achieving a Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12|The PGA documents the physician’s assessment of the participant’s psoriasis status according to the following categories: induration, scaling, and erythema. The participant's psoriasis is assessed as 5-point scale as follows: cleared (0), minimal (1), mild (2), moderate (3), or severe (4); higher score indicates worse disease. The table below shows the percentage of participants who achieved a PGA score of 0 or 1 at Week 12 in each treatment group.|Week 12|The primary efficacy analysis was performed using the all randomized subjects analysis set defined as the population of all participants who were randomized to any treatment group.||Percentage of Participants|||Number
846863|NCT01084278|Primary|Percentage of Colchicine Dose Recovered in Dialysate|The cumulative percentage of the colchicine dose recovered in dialysate.|Day 15, post-dose during dialysis|ESRD participants on dialysis, where data were available.||percent dose||Standard Deviation|Mean
846864|NCT01084278|Primary|Dialysis Clearance of Colchicine (CLD)|The dialysis clearance of colchicine, calculated as amount of colchicine recovered in dialysate / AUCt2-t1 where t1 and t2 are the times of the start and end of hemodialysis.|Day 15, post-dose during dialysis|ESRD participants on dialysis, where data were available.||L/h||Standard Deviation|Mean
846865|NCT01084278|Primary|Renal Clearance of Colchicine (CLR)|Renal clearance of colchicine, calculated as Ae(0 t)/AUC 0-t.|Pre-dose on Day 1 and up to 120 hours post dose.|Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis.||L/hr||Standard Deviation|Mean
846866|NCT01084278|Primary|Percentage of Colchicine Dose Excreted in Urine up to the Final Collection Time|The cumulative percentage of the colchicine dose excreted in urine up to the final collection time, calculated as Ae(0-t) × 100/dose|Pre-dose on Day 1 and up to 120 hours post dose.|Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis.||percent of dose||Standard Deviation|Mean
846867|NCT01084278|Primary|Amount of Colchicine Excreted in Urine (Ae[0-t])|The amount of colchicine excreted in urine during the post-dose collection, calculated as the sum of the amounts in the individual collection intervals (Ae).|Pre-dose on Day 1 and up to 120 hours post dose.|Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis.||mg||Standard Deviation|Mean
846868|NCT01084278|Primary|Weight-adjusted Apparent Total Body Clearance of Colchicine|The apparent total body clearance after administration of colchicine, calculated as Dose/AUC(0-∞) and normalized to body weight (in kilograms).|Day 1 and Day 15 (for ESRD patients only) pre-dose and at 0.5, 1, 1.5 , 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 hours post dose.|Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis.||L/hr/kg||Standard Deviation|Mean
846869|NCT01084278|Primary|Apparent Total Body Clearance of Colchicine|The apparent total body clearance after administration of colchicine, calculated as Dose/AUC(0-∞).|Day 1 and Day 15 (for ESRD patients only) pre-dose and at 0.5, 1, 1.5 , 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 hours post dose.|Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis.||L/hr||Standard Deviation|Mean
846870|NCT01084278|Primary|Weight-adjusted Apparent Total Volume of Distribution After Administration (V-area/F)|The apparent total volume of distribution after administration of colchicine, calculated as Dose / (AUC0-∞ × Kel), and normalized to body weight.|Day 1 and Day 15 (for ESRD patients only) pre-dose and at 0.5, 1, 1.5 , 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 hours post dose.|Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis.||L/kg||Standard Deviation|Mean
846871|NCT01084278|Primary|The Apparent Total Volume of Distribution After Administration (V-area/F)|The apparent total volume of distribution after administration of colchicine, calculated as Dose / (AUC0-∞ × Kel).|Day 1 and Day 15 (for ESRD patients only) pre-dose and at 0.5, 1, 1.5 , 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 hours post dose.|Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis.||L||Standard Deviation|Mean
846872|NCT01084278|Primary|Apparent First-order Terminal Elimination Half-life (t½)|The apparent first-order terminal elimination half-life was calculated as 0.693/Kel.|Day 1 and Day 15 (for ESRD patients only) pre-dose and at 0.5, 1, 1.5 , 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 hours post dose.|Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis.||hr||Standard Deviation|Mean
846873|NCT01084278|Primary|Apparent First-order Terminal Elimination Rate Constant (Kel)|Apparent first-order terminal elimination rate constant calculated from a semi-log plot of the plasma concentration versus time curve for colchicine. The parameter was calculated by linear least-squares regression analysis using the maximum number of points in the terminal log-linear phase (e.g., three or more non-zero plasma concentrations).|Day 1 and Day 15 (for ESRD patients only) pre-dose and at 0.5, 1, 1.5 , 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 hours post dose.|Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis.||1/hr||Standard Deviation|Mean
846874|NCT01084278|Primary|Area Under the Concentration Time Curve From Time Zero to Infinity (AUC 0 - ∞)|The area under the plasma concentration versus time curve extrapolated to infinity. AUC 0 - ∞ is calculated as the sum of total AUC 0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant.|Day 1 and Day 15 (for ESRD patients only) pre-dose and at 0.5, 1, 1.5 , 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 hours post dose.|Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis.||ng*h/mL||Standard Deviation|Mean
846875|NCT01084278|Primary|Area Under the Concentration Time Curve From Time Zero to the Time of Last Measured Concentration (AUC 0-t)|The area under the plasma concentration versus time curve beginning from the first dose until the last quantifiable concentration, calculated by the linear trapezoidal method.|Day 1 and Day 15 (ESRD patients only), predose and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post dose|Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis.||ng*h/mL||Standard Deviation|Mean
846876|NCT01084278|Primary|Time to Maximum Plasma Concentration (Tmax)|The time to reach the maximum or peak concentration of colchicine in the plasma.|Day 1 and Day 15 (for ESRD patients only) at 0.5, 1, 1.5 , 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 hours post dose|Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis.||hours||Standard Deviation|Mean
846877|NCT01084278|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration of colchicine in the plasma.|Day 1 and Day 15 (for ESRD patients only) pre-dose and at 0.5, 1, 1.5 , 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 hours post dose|Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis.||ng/mL||Standard Deviation|Mean
846878|NCT01076686|Primary|Number of Subjects With Breast Implant Rupture|Breast implant rupture and integrity were assessed by reviewing the results of history and physical focused on clinical sequelae of augmentation mammoplasty|12 to 24 months post surgery|||participants|||Number
846881|NCT01025336|Primary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 in Parent Study 6115A1-3005 (NCT00546572)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CIs) for the GMTs are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the titers.|Month 1/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336)|All-Available Immunogenicity Population. N=number of participants with valid and determinate antibody titer for the specified serotype.||titer||95% Confidence Interval|Geometric Mean
846882|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC 1 Year After Vaccination 1 Compared to 23vPS 1 Year After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 0/Year 1 (Parent Study NCT00546572)|All-Available Immunogenicity Population. N=number of participants with a determinate OPA antibody titer to the given serotype.||titer||95% Confidence Interval|Geometric Mean
846883|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC 1 Year After Vaccination 1 Compared to 23vPS 1 Year After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 0/Year 1 (Parent Study NCT00574548)|All-Available Immunogenicity Population. N=number of participants with a determinate OPA antibody titer to the given serotype.||titer||95% Confidence Interval|Geometric Mean
846884|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 0/Year 1 (Parent Study NCT00546572), Month 0/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336)|All-Available Immunogenicity Population. N=number of participants with a determinate OPA antibody titer to the given serotype.||titer||95% Confidence Interval|Geometric Mean
846885|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 23vPS/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC 1 Year After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 0/Year 1 (Parent Study NCT00546572), Month 1/Year 2 (Baseline; Follow-up Study NCT01025336)|All-Available Immunogenicity Population. N=number of participants with a determinate OPA antibody titer to the given serotype.||titer||95% Confidence Interval|Geometric Mean
846886|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC Before Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 0/Year 1 (Parent Study NCT00574548), Month 0/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336)|All-Available Immunogenicity Population. N=number of participants with a determinate OPA antibody titer to the given serotype.||titer||95% Confidence Interval|Geometric Mean
846887|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 23vPS/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC 1 Year After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 0/Year 1 (Parent Study NCT00574548), Month 0/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336)|All-Available Immunogenicity Population. N=number of participants with a determinate OPA antibody titer to the given serotype.||titer||95% Confidence Interval|Geometric Mean
846888|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/23vPS 1 Year After Vaccination 2 Compared to 23vPS 1 Year After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 0/Year 1 (Parent Study NCT00574548), Month 0/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336)|All-Available Immunogenicity Population. N=number of participants with a determinate OPA antibody titer to the given serotype.||titer||95% Confidence Interval|Geometric Mean
846911|NCT00996307|Secondary|Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010|Subgroup analysis based on receipt of recent seasonal vaccination. Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines.|Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination)|The analysis was done on the subgroup of the per-protocol set(PPS).||Percentages of Subjects||95% Confidence Interval|Number
846889|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/13vPnC Compared to 23vPS/13vPnC (Parent Study 6115A1-3005; NCT00546572)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 0/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336)|All-Available Immunogenicity Population. N=number of participants with a determinate OPA antibody titer to the given serotype.||titer||95% Confidence Interval|Geometric Mean
846890|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/13vPnC Compared to 13vPnC/23vPS (Parent Study 6115A1-3010; NCT00574548)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 0/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336)|All-Available Immunogenicity Population. N=number of participants with a determinate OPA antibody titer to the given serotype.||titer||95% Confidence Interval|Geometric Mean
846891|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/13vPnC Compared to 23vPS/13vPnC (Parent Study 6115A1-3010; NCT00574548)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 0/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336)|All-Available Immunogenicity Population. N=number of participants with a determinate OPA antibody titer to the given serotype.||titer||95% Confidence Interval|Geometric Mean
846892|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/23vPS Compared to 23vPS/13vPnC (Parent Study 6115A-3010; NCT00574548)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 0/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336)|All-Available Immunogenicity Population. N=number of participants with a determinate OPA antibody titer to the given serotype.||titer||95% Confidence Interval|Geometric Mean
846893|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 0/Year 0 (Parent Study NCT00546572), Month 1/Year 2 (Follow-up Study NCT01025336)|All-Available Immunogenicity Population. N=number of participants with valid and determinate assay results for the specified serotype at both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||titer||95% Confidence Interval|Geometric Mean
846894|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 0/Year 0 (Parent Study NCT00574548), Month 1/Year 2 (Follow-up Study NCT01025336)|All-Available Immunogenicity Population. N=number of participants with valid and determinate assay results for the specified serotype at both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||titer||95% Confidence Interval|Geometric Mean
846895|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 1/Year 0 (Parent Study NCT00546572), Month 1/Year 2 (Follow-up Study NCT01025336)|All-Available Immunogenicity Population. N=number of participants with valid and determinate assay results for the specified serotype at both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||titer||95% Confidence Interval|Geometric Mean
846896|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 1/Year 0 (Parent Study NCT00574548), Month 1/Year 2 (Follow-up Study NCT01025336)|All-Available Immunogenicity Population. N=number of participants with valid and determinate assay results for the specified serotype at both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||titer||95% Confidence Interval|Geometric Mean
846897|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 0/Year 1 (Parent Study NCT00546572), Month 1/Year 2 (Follow-up Study NCT01025336)|All-Available Immunogenicity Population. N=number of participants with valid and determinate assay results for the specified serotype at both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||titer||95% Confidence Interval|Geometric Mean
846898|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 0/Year 1 (Parent Study NCT00574548), Month 1/Year 2 (Follow-up Study NCT01025336)|All-Available Immunogenicity Population; N=number of participants with valid and determinate assay result for specified serotype at both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||titer||95% Confidence Interval|Geometric Mean
846899|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 1/Year 1 (Parent study/NCT00546572), Month 1/Year 2 (Follow-up Study/NCT01025336)|All-Available Immunogenicity Population; N=number of participants with valid and determinate assay result for specified serotype at both 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||titer||95% Confidence Interval|Geometric Mean
846900|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 1/Year 1 (Parent study/NCT00574548), Month 1/Year 2 (Follow-up Study/NCT01025336)|All-Available Immunogenicity Population; N=number of participants with valid and determinate assay result for specified serotype at both 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||titer||95% Confidence Interval|Geometric Mean
846901|NCT01025336|Primary|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Antibody Persistence 1 Year After Vaccination (Vax) 2 in Parent Study 6115A1-3010 (NCT00574548)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CIs) for the GMTs are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the titers.|Month 1/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336)|All-Available Immunogenicity Population included all participants enrolled in 6115A1-3018 (NCT01025336) with a valid and determinate assay result who received both vaccinations in either parent study 6115A1-3010 (NCT00574548) or 6115A1-3005 (NCT00546572). N=number of participants with valid and determinate antibody titer for the specified serotype.||titer||95% Confidence Interval|Geometric Mean
846902|NCT01005966|Secondary|Change From Baseline in Enamel Fluoride Uptake Potential|Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on the amount of fluoride (F) divided by the area of the enamel cores. The difference between treatments was calculated with respect to fluoride uptake by enamel.|Baseline to 14 days|PP population: All randomized participants who received at least one dose of the study treatments or provided at least one significant measurement of fluoride uptake. Participants without any major protocol violations in given study treatment period were included in the PP population.||micrograms (μg)* F/centimeters(cm)^2||Standard Error|Mean
846903|NCT01005966|Secondary|Percent SMH Recovery of Enamel Specimens Exposed to NaF Toothpaste (1426ppmF), NaF Toothpaste (675ppmF), NaMFP/NaF Toothpaste (1400ppm F) and Placebo (0ppmF)|SMH test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Differences in percent SMH recovery due to study and reference toothpastes were calculated.|Baseline to 14 days|PP population: All randomized participants who received at least one dose of the study treatments or provided at least one measurement SMH. Participants without any major protocol violations in given study treatment period were included in the PP population.||Percentage SMHR||Standard Error|Mean
846904|NCT01005966|Primary|Percent Surface Microhardness (SMH) Recovery of Enamel Specimens Exposed to NaF Toothpaste (1426ppmF) and AmF Toothpaste (1400ppmF)|SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Difference in percent SMH recovery was calculated by comparing study NaF toothpaste (1426ppmF) with reference AmF toothpaste (1400ppmF).|Baseline to 14 days|Per protocol (PP) population: All randomized participants who received at least one dose of the study treatments and provided at least one measurement SMH. Participants without any major protocol violations in given study treatment period were included in the PP population.||Percentage SMHR||Standard Error|Mean
846905|NCT01001975|Primary|Determination of Ultraviolet A Protection Factor (PFA)|Test materials (V53-028 and V53-030) were applied to test area. Following a series of Ultraviolet radiation A (UVA) exposures, scores were recorded at 2 and 4 hours post-exposure, to determine the Minimal Persistent Pigment-Darkening Dose (MPPD) of protected and unprotected skin. PFA was calculated as the MPPD of protected skin divided by the MPPD of unprotected skin. Expected PFA is a score on a scale; range 6.40 (worst) to 15.62 (best).|2 to 4 hours post-exposure|Only subjects from the UVA Protection Testing group had V53-028 and V53-030 applied for the determination of PFA||Score on a scale||Standard Deviation|Mean
846906|NCT01001975|Primary|Determination of Sunscreen Protection Factor (SPF)|Test material (V53-028 and V53-030) and control test material (8% Homoslate SPF 4) were applied to test area. Following exposure to a series of Ultraviolet light exposures, SPF scores were recorded at 16 to 24 hours post-exposure, to determine the Minimal Erythema Dose (MED) of protected and unprotected skin. SPF was calculated as the MED of protected skin divided by the MED of unprotected skin. Expected SPF 15 is a score on a scale; range 11.34 (worst) to 19.83 (best).|16 to 24 hours post-exposure|Only subjects from the SPF Testing group had V53-028 and V53-030 applied for the determination of SPF||Score on a scale||Standard Deviation|Mean
846907|NCT00996307|Secondary|Antibody Persistence by Geometric Mean Titers (GMT)|Immunogenicity was assessed in terms of Geometric Mean Titers (GMT at 6 months (Day 202)and 12 months (Day 387) after second vaccination.|6 months (Day 202) and 12 months (Day 387) after second vaccination|The analysis was done on the subgroup of the per-protocol set (PPS).||Titer||95% Confidence Interval|Geometric Mean
846908|NCT00996307|Secondary|Geometric Mean Titers (GMTs) Based on Baseline Seropositivity|Subgroup analysis based on Subjects with a pre-vaccination HI antibody titer < 1:10 and prevaccination HI antibody titer ≥ 1:10 Immunogenicity responses in subjects who are seropositive (A/H1N1 2009 HI titer ≥ 1:10) at Baseline (Day 1 (pre-vaccination)) as compared to those who are seronegative (HI titer < 1:10).|Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination)|The analysis was done on the subgroup of the per-protocol set (PPS).||Titres||95% Confidence Interval|Geometric Mean
846912|NCT00996307|Primary|Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination|Safety was measured in terms of the number of participants reporting solicited local and systemic reactions after second vaccination.|Day 22 to 28|The analysis was done on the safety set. Almost all the subjects across the vaccine groups received their first and second vaccinations within the protocol-specified window. While all the enrolled subjects received their first vaccination, 3% to 7% of subjects across the vaccine groups did not receive their second vaccination.||Participants|||Number
846913|NCT00996307|Primary|Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination|Safety was measured in terms of the number of participants reporting solicited local and systemic reactions after first vaccination.|Day 1 to 7|The analysis was done on the safety set which included the five subjects who received wrong vaccination according to the randomization. These five subjects were excluded from PPS.||Participants|||Number
846914|NCT00996307|Secondary|Immunogenicity Measurement by Geometric Mean Titers (GMT)|Immunogenicity was measured in terms of the GMT at 21 days after each vaccination.|21 days after each vaccination|The analysis was done on the Full Analysis Set (FAS).||Titers||95% Confidence Interval|Geometric Mean
846915|NCT00996307|Primary|Antibody Responses After the First and Second Vaccinations|CBER guidance (<65 years of age): The lower bound of the two-sided 95% CI for the percent of subjects achieving seroconversion for HI antibody should be ≥ 40% AND the lower bound of the two sided 95% CI for the percent of subjects achieving an HI antibody titer ≥ 1:40 should be ≥ 70%.|21 days after each vaccination|The analysis was done on the per-protocol set (PPS).||Percentages of Subjects||95% Confidence Interval|Number
846916|NCT00996281|Secondary|Percentage of Participants With Serum Creatinine Elevations Greater Than 50% From Baseline and Greater Than the Upper Limit of Normal (ULN)|Serum creatinine was measured at every visit and evaluated as a laboratory parameter of special interest. The percentage of participants with creatinine increase ≥50% from Baseline and greater than ULN was summarized: - At any visit (includes transient and persistent elevations). - At the Final Visit (includes persistent elevations and participants whose first elevation may have been at the Final Visit). - At least 2 consecutive visits (includes only persistent elevations).|Baseline and Week 52|Safety analysis set.||percentage of participants|||Number
846917|NCT00996281|Primary|Percentage of Participants With at Least 1 Adverse Event|An adverse event is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product without regard to causality.|From Week 0 (Day 1) to Week 52.|Safety analysis set: All participants who received at least 1 dose of study medication.||percentage of participants|||Number
846918|NCT00995722|Secondary|Change in Quality of Life as Measured by the 10-Item Neuro-ophthalmological Supplement to the NEI-VFQ-25||4 months|||units on a scale||95% Confidence Interval|Mean
846919|NCT00995722|Secondary|Change in Quality of Life as Measured by the MG-QOL-15 Score||4 Months|||units on a scale||95% Confidence Interval|Mean
846920|NCT00995722|Secondary|Change in Quality of Life as Measured by the NEI-VFQ-25 Measures||4 months|||units on a scale||95% Confidence Interval|Mean
846921|NCT00995722|Secondary|Change in Ocular Quantitative Myasthenia Score From Baseline to Week 16||4 months|||units on a scale||95% Confidence Interval|Mean
846922|NCT00995722|Primary|Treatment Failure|Failure to achive sustatined minimal manifestation status by week 16|4 months|||percentage of participants||95% Confidence Interval|Number
846925|NCT00984659|Primary|SOBDA Threshold for Response Assessed as Mean Change From Baseline to Last Treatment Week in the SOBDA Score Based on Forced Expiratory Volume in One Second (FEV1) Change From Baseline of 50 Milliliters (mL) to <100 mL|FEV1 response was rated as 1=No change or worse (i.e., change of <50 mL); 2=Better (i.e., change of 50 to <100 mL); 3=Much better (i.e., change of >=100 mL). The threshold of response is a score change in the SOBDA questionnaire that is demonstrated to have a perceivable benefit for the participant. The threshold of response was evaluated as the change from Baseline in the SOBDA score based on study assessment (FEV1) scores pre-specified as “better” or demonstrating meaningful improvement.|Baseline and Week Prior to Visit 3/PD (end of 6-week Treatment Period or earlier up to Week 8)|MITT Population. Analyses were conducted on data available for each specified time point. As pre-specified in the study protocol, results are presented independent of treatment allocation. The study objectives were to assess the measurement properties and validity of the SOBDA questionnaire independent of specific treatment effect.||mL||Standard Deviation|Mean
846926|NCT00984659|Primary|SOBDA Threshold for Response as Assessed by Mean Change From Baseline to the Last Treatment Week in the SOBDA Score Based on a CRQ-SAS Dyspnea Domain (DD) Response Rated as “Better”|The threshold of response (TOR) is a score change in the SOBDA questionnaire that is demonstrated to have a perceivable benefit. The TOR was evaluated as the change from Baseline in the SOBDA score based on CRQ-SAS scores pre-specified as “better” or demonstrating meaningful improvement. The CRQ-SAS DD includes 5 questions (q.) scored 1 (maximum impairment) to 7 (no impairment). Individual q. were equally weighted, and domain scores (DSs) (range=1-7) were calculated as the mean across the non-missing items within each domain (DSs were calculated although an individual item score was missing).|Baseline and Week Prior to Visit 3/PD (end of 6-week Treatment Period or earlier up to Week 8)|MITT Population. Analyses were conducted on data available for each specified time point. As pre-specified in the study protocol, results are presented independent of treatment allocation. The study objectives were to assess the measurement properties and validity of the SOBDA questionnaire independent of specific treatment effect.||Scores on a scale||Standard Deviation|Mean
846970|NCT00952341|Secondary|Proportion of Participants With Complete Response in the Acute Phase of Cycle 1|"Acute phase was defined as 0 to 24 hours following initiation of chemotherapy.
Complete response was defined as no vomiting with no rescue therapy."|0 to 24 hours|Full Analysis Set (FAS), defined as those who received chemotherapy, received a dose of study drug and had at least one post-treatment assessment. Any participant who did not have a response recorded for the assessment was excluded from the analysis.||Proportion of participants|||Number
846927|NCT00984659|Primary|SOBDA Threshold for Response as Assessed by Mean Change From Baseline to the Last Treatment Week in the SOBDA Score Based on a CGI-C Response Rated as “Better”|The threshold of response is a score change in the SOBDA questionnaire that is demonstrated to have a perceivable benefit for the participant. The threshold of response was evaluated as the change from Baseline in the SOBDA score based on CGI-C scores pre-specified as “better” or demonstrating meaningful improvement. The CGI-C is clinician completed on a 1 to 5 scale: 1, much worse, 2, worse; 3, no change; 4, better; 5, much better.|Baseline and Week Prior to Visit 3/PD (end of 6-week Treatment Period or earlier up to Week 8)|MITT Population. Analyses were conducted on data available for each specified time point. As pre-specified in the study protocol, results are presented independent of treatment allocation. The study objectives were to assess the measurement properties and validity of the SOBDA questionnaire independent of specific treatment effect.||Scores on a scale||Standard Deviation|Mean
846928|NCT00984659|Primary|SOBDA Threshold for Response Assessed as Mean Change From the Previous Week’s SOBDA Score Based on a Participant-completed PGAC Score Rated of “Better”|Changes from Baseline in the SOBDA score for responders (Rs) and non-responders (NRs) (using the PGAC assessment; 1 [much worse] to 5 [much better]), together with the cumulative proportions of Rs and NRs, was used to establish the threshold for defining SOBDA questionnaire Rs. The threshold of response is a score change in the SOBDA questionnaire that is demonstrated to have a perceivable benefit for the participant. The threshold of response was evaluated as the change from Baseline in the SOBDA score based on PGAC scores pre-specified as “better” or demonstrating meaningful improvement.|Baseline (last week of the 2-week Run-in Period) and Weeks 1, 2, 3, 4, 5, and 6 (6-week Treatment Period)|MITT Population. Analyses were conducted on data available for each specified time point. As pre-specified in the study protocol, results are presented independent of treatment allocation . The study objectives were to assess the measurement properties and validity of the SOBDA questionnaire independent of specific treatment effect.||scores on a scale||Standard Deviation|Mean
846929|NCT00984659|Primary|Change From Baseline to Last Treatment Week in the SOBDA Score by Physician-completed mMRC and Participant-completed mMRC Responses at Visit 3/PD|The responsiveness of the SOBDA questionnaire was assessed by comparing score changes between responders and non-responders. The mMRC ranges from 0 (no breathlessness except with strenous exercise) to 4 (too breathless to leave the house; breathless when dressing/undressing) and is completed by the clinician or the participant as indicated. Changes in mean SOBDA scores during the last week of treatment in responders and non-responders using definitions based on the Physician-completed (Ph-C) and Participant-completed (Pa-C) mMRC conducted at Visit 3/Premature Discontinuation were assessed.|Baseline (2-week Run-in Period) and Week Prior to Visit 3/PD (end of 6-week Treatment Period or earlier up to Week 8)|MITT Population. Analyses were conducted on data available for each specified time point. As pre-specified in the study protocol, results are presented independent of treatment allocation. The study objectives were to assess the measurement properties and validity of the SOBDA questionnaire independent of specific treatment effect.||Scores on a scale||Standard Deviation|Mean
846930|NCT00984659|Primary|Change From Baseline to Last Treatment Week in the SOBDA Score by CRQ-SAS Dyspnea Domain (DD) Responses at Visit 3/PD|The responsiveness of the SOBDA questionnaire was assessed by comparing score changes of responders (Rs) versus non-responders (NRs). The CRQ-SAS DD includes 5 questions (q.) scored 1 (maximum impairment) to 7 (no impairment). Individual q. were equally weighted, and domain scores (DSs) (range=1-7) were calculated as the mean across the non-missing items within each domain (DSs were calculated although an individual item score was missing). Changes in mean SOBDA scores during the last treatment week in Rs and NRs using definitions based on the CRQ-SAS DD conducted at Visit 3/PD were assessed.|Baseline (2-week Run-in Period) and Week Prior to Visit 3/PD (end of 6-week Treatment Period or earlier up to Week 8)|MITT Population. Analyses were conducted on data available for each specified time point. As pre-specified in the study protocol, results are presented independent of treatment allocation. The study objectives were to assess the measurement properties and validity of the SOBDA questionnaire independent of specific treatment effect.||Scores on a scale||Standard Deviation|Mean
846931|NCT00984659|Primary|Change From Baseline to Last Treatment Week in the SOBDA Score by CGI-C Responses at Visit 3/PD|The responsiveness of the SOBDA questionnaire was assessed by comparing score changes between responders and non-responders. The CGI-C is clinician completed on a 1 to 5 scale: 1, much worse; 2, worse; 3, no change; 4, better; 5, much better. Changes in mean SOBDA scores during the last week of treatment in responders and non-responders using definitions based on the CGI-C conducted at Visit 3/Premature Discontinuation were assessed.|Baseline (2-week Run-in Period) and Week Prior to Visit 3/PD (end of 6-week Treatment Period or earlier up to Week 8)|MITT Population. Analyses were conducted on data available for each specified time point. As pre-specified in the study protocol, results are presented independent of treatment allocation. The study objectives were to assess the measurement properties and validity of the SOBDA questionnaire independent of specific treatment effect.||scores on a scale||Standard Deviation|Mean
846932|NCT00984659|Primary|Number of Participants Classified as Responders and Non-responders by Physician-completed and Participant-completed mMRC Response at Visit 3/PD|A Physician-completed and Participant-completed mMRC responder was defined as a participant who had a score decrease of one unit or more between Visit 2 and Visit 3/Premature Discontinuation. A non-responder was defined as a participant who had the same score or an increase in score.|Visit 3/PD (end of 6-week Treatment Period or earlier up to Week 8)|MITT Population. Analyses were conducted on data available for each specified time point. As pre-specified in the study protocol, results are presented independent of treatment allocation. The study objectives were to assess the measurement properties and validity of the SOBDA questionnaire independent of specific treatment effect.||participants|||Number
846933|NCT00984659|Primary|Number of Participants Classified as Responders and Non-responders by CRQ-SAS Dyspnea Domain Response at Visit 3/PD|A CRQ-SAS dyspnea domain responder was defined as a participant who had a score increase of 0.5 units or more for the dyspnea domain of the CRQ-SAS between Visit 2 and Visit 3/Premature Discontinuation. A non-responder was defined as a participant who had a decrease in the score, or an increase of less than 0.5 units.|Visit 3/PD (end of 6-week Treatment Period or earlier up to Week 8)|MITT Population. Analyses were conducted on data available for each specified time point. As pre-specified in the study protocol, results are presented independent of treatment allocation. The study objectives were to assess the measurement properties and validity of the SOBDA questionnaire independent of specific treatment effect.||participants|||Number
847000|NCT00882557|Other Pre-specified|Half-life|Apparent terminal half-life.|Up to 68 hours post dose|||Hours||Full Range|Median
846934|NCT00984659|Primary|Number of Participants Classified as Responders and Non-responders by Clinician Global Impression of Change Question (CGI-C) Response at Visit 3/PD|"Clinicians were asked to provide their clinical impression regarding change in the participant’s shortness of breath by CGI-C. This was evaluated on a 1-5 Likert scale: 1 (much worse) to 5 (much better), with 3 being no change. A CGI-C responder was defined as a participant who had a response of better (4) or much better (5), and a non-responder was defined as a participant who had a response of much worse (1), worse (2), or no change (3)."|Visit 3/PD (end of 6-week Treatment Period or earlier up to Week 8)|MITT Population. Analyses were conducted on data available for each specified time point. As pre-specified in the study protocol, results are presented independent of treatment allocation. The study objectives were to assess the measurement properties and validity of the SOBDA questionnaire independent of specific treatment effect.||participants|||Number
846935|NCT00984659|Primary|Change From the Previous Week to the Current Week’s SOBDA Score by Participant-completed PGAC Response at Days 8, 15, 22, 29, 36, and 43 and at Visit 3/PD (End of the 6-week Treatment Period or PD)|"Responsiveness reflects the ability of the SOBDA questionnaire to detect change under conditions of known change. Responders (Rs)=participants (par.) with a rating of better/much better (score of 4/5) on the PGAC (range; 1 [much worse] to 5 [much better]) at the relevant week; NRs=par. with a response of “much worse, worse, or no change (score of 3). Mean difference between Rs and NRs in the change from the previous week to the current week’s SOBDA score was calculated. For Visit 3/PD, the change from Baseline to the last treatment week's SOBDA score for Rs and NRs was calculated."|Baseline; Days 8, 15, 22, 29, 36, and 43 and Visit 3/PD (end of 6-week Treatment Period or earlier up to Week 8)|MITT Population. Analyses were conducted on data available for each specified time point. As pre-specified in the study protocol, results are presented independent of treatment allocation. The study objectives were to assess the measurement properties and validity of the SOBDA questionnaire independent of specific treatment effect.||scores on a scale||Standard Deviation|Mean
846936|NCT00984659|Primary|Participants (Par.) Classified as Responders/Non-responders According to the Patient Global Assessment of Change (PGAC) Response at Days 8, 15, 22, 29, 36, and 43 and at Visit 3/Premature Discontinuation (PD) (the End of the 6-week Treatment Period or PD)|"The PGAC is par. completed on a 1-5 scale: 1, much worse; 2, worse; 3, no change; 4, better; 5, much better. Responders were defined as par. with a rating of better or much better (score of 4 or 5) on the PGAC at the relevant week; non-responders were defined as par. with a response of “much worse, worse, or no change on the PGAC. As pre-specified in the study protocol, results are presented independent of treatment allocation . The study objectives were to assess the measurement properties and validity of the SOBDA questionnaire independent of specific treatment effect."|Days 8, 15, 22, 29, 36, and 43 and Visit 3/PD (end of 6-week Treatment Period or earlier up to Week 8)|Modified Intent-to-Treat (MITT) Population: all participants randomized to treatment who received at least one dose of study medication. Analyses were conducted on data available for each specified time point.||participants|||Number
846937|NCT00984659|Primary|Known Group Validity (KGV) for the SOBDA Questionnaire Measured as the Comparison of the Baseline SOBDA Score in the Indicated Categories of CGI-S Scores at Visit 2|SOBDA KGV refers to the extent to which scores from the SOBDA questionnaire should differentiate participants with varying levels of dyspnea severity. It was assessed by comparing summary measures for the SOBDA score for each indicated level (0, 1, 2, 3, and 4) of the CGI-S score. Clinicians were asked to assess the severity of the participant’s dyspnea on the CGI-S scale. This was evaluated on a 1-4 Likert scale: 1 (mild) to 4 (very severe). KGV was confirmed if the SOBDA score increased with increasing values of CGI-S, both indicating increased levels of breathlessness.|Baseline (last week of the 2-week Run-in Period) and pre-treatement on Visit 2 (Day 1 of the 6-week Treatment Period)|Run-in Population. Participants with a SOBDA Baseline score and the CGI-S score at Visit 2 were analyzed.||scores on a scale||Standard Error|Least Squares Mean
846938|NCT00984659|Primary|Known Group Validity for the SOBDA Questionnaire Measured as the Comparison of the Baseline SOBDA Score in the Indicated Categories of the Participant-completed (ParC) mMRC Score at Visit 2|SOBDA known group validity refers to the extent to which scores from the SOBDA questionnaire should differentiate participants with varying levels of dyspnea severity. It was assessed by comparing summary measures for the SOBDA score for each indicated level (0, 1, 2, 3, and 4) of the ParC mMRC. The participant rated the degree of his/her dyspnea on the 5-point mMRC scale: 0 (none) to 4 (very severe). Known group validity was confirmed if the SOBDA score increased with increasing values of ParC mMRC, both indicating increased levels of breathlessness.|Baseline (last week of the 2-week Run-in Period) and pre-treatment on Visit 2 (Day 1 of the 6-week Treatment Period)|Run-in Population. Participants with a SOBDA Baseline score and the Participant-completed mMRC score at Visit 2 were analyzed.||scores on a scale||Standard Error|Least Squares Mean
846939|NCT00984659|Primary|Known Group Validity for the SOBDA Questionnaire Measured as the Comparison of the Baseline SOBDA Score in the Indicated Categories of the Physician-completed (PyC) mMRC Score at Visit 2|SOBDA known group validity refers to the extent to which scores from the SOBDA questionnaire should differentiate participants with varying levels of dyspnea severity. It was assessed by comparing summary measures for the SOBDA score for each indicated level (0, 1, 2, 3, and 4) of the PyC mMRC. The physician rated the degree of the participant's dyspnea on the 5-point mMRC scale: 0 (none) to 4 (very severe). Known group validity was confirmed if the SOBDA score increased with increasing values of PyC mMRC, both indicating increased levels of breathlessness.|Baseline (last week of the 2-week Run-in Period) and pre-treatment on Visit 2 (Day 1 of the 6-week Treatment Period)|Run-in Population. Participants with a SOBDA Baseline score and the Physician-completed mMRC score at Visit 2 were analyzed.||scores on a scale||Standard Error|Least Squares Mean
846940|NCT00984659|Primary|Convergent Validity (CV) for the SOBDA Questionnaire Measured as the Correlation of the Baseline SOBDA Score With the Chronic Respiratory Disease Questionnaire-Self-Administered Standardized (CRQ-SAS) Dyspnea Domain Score at Visit 2|Convergent validity is defined as the ability of the SOBDA questionnaire to measure required information and was assessed by examining the relationship between the SOBDA score and the CRQ-SAS dyspnea domain score. Pearson's correlation coefficient is a measure of the linear dependence between 2 variables. A correlation of +1 or -1 will occur if the data from the 2 variables lie exactly on a line. The CRQ is a 20-item instrument measuring 4 domains (each measured on a scale of 1 [maximum impairment] to 7 [no impairment]) of functioning: mastery, fatigue, emotional function, and dyspnea.|Baseline (last week of the 2-week Run-in Period) and pre-treatment on Visit 2 (Day 1 of the 6-week Treatment Period)|Run-in Population. Participants with a SOBDA Baseline score and the indicated assessment at Visit 2 were analyzed.||Pearson's correlation coefficient|||Number
846941|NCT00984659|Primary|Convergent Validity for the SOBDA Questionnaire Measured as the Correlation of the Baseline SOBDA Score With the Clinician Global Assessment of Dyspnea Severity (CGI-S) Score at Visit 2|Convergent validity is defined as the ability of the SOBDA questionnaire to measure the required information and was assessed by examining the relationship between the SOBDA score with the CGI-S score. Spearman's rank correlation coefficient assesses if the relationship between two variables is monotone. A correlation of +1 or -1 will occur if one variable is a perfect monotone of the other. Clinicians were asked to assess the severity of the participant’s dyspnea on the CGI-S scale. This was evaluated on a 1-4 Likert scale: 1 (mild) to 4 (very severe).|Baseline (last week of the 2-week Run-in Period) and pre-treatment on Visit 2 (Day 1 of the 6-week Treatment Period)|Run-in Population. Participants with a SOBDA Baseline score and the indicated assessment at Visit 2 were analyzed.||Spearman rank correlation coefficient|||Number
846942|NCT00984659|Primary|Convergent Validity for the SOBDA Questionnaire Measured as Correlations of the Baseline SOBDA Score With Participant-completed Modified Medical Research Council (mMRC) and Physician-completed mMRC Scores at Visit 2|Convergent validity is defined as the ability of the SOBDA questionnaire to measure required information and was assessed by examining the relationship between the SOBDA score and the participant/physician-completed mMRC Dyspnea Scale assessments. The physician/participant rated the degree of the participant's dyspnea (trouble breathing) on the 5-point mMRC scale (0, none; 4, very severe). Spearman's rank correlation coefficient assesses if the relationship between two variables is monotone. A correlation of +1 or -1 will occur if one variable is a perfect monotone of the other.|Baseline (last week of the 2-week Run-in Period) and pre-treatment on Visit 2 (Day 1 of the 6-week Treatment Period)|Run-in Population. Participants with a SOBDA Baseline score and the indicated assessment at Visit 2 were analyzed. One participant who rated their own trouble breathing had missing data for the physician assessment.||Spearman rank correlation coefficient|||Number
846943|NCT00984659|Primary|Test-retest Reliability (T-RR) of SOBDA Scores Measured as the Difference in the SOBDA Weekly Score Between Week 1 and Week 2 of the 2-week Run-in Period|T-RR=stability during repeat measures over time in a stable population. SOBDA score was determined by the 13-item (it.) scoring algorithm, assigning a weekly mean score of 1-4 (higher scores=more severe breathlessness with daily activities) based on the mean of 7 days of data (or >=4 days). Daily total score is computed from the mean of the participant's (par.) scores on the 13 it. (>=7 it. must have non-missing responses). Only scores of stable par. (indicating no change [score=3] on the par.-completed Patient Global Assessment of Change [PGAC]; 1 [ much worse] to 5 [much better]) were used.|Week 1 and Week 2 of the 2-week Run-in Period|Run-in Population. Data from participants with weekly SOBDA scores at Week 1 and Week 2 of the 2-week Run-in Period and reporting no change on the second weekly PGAC were analyzed.||scores on a scale||Standard Deviation|Mean
846944|NCT00984659|Primary|Internal Consistency (IC) of the Shortness of Breath With Daily Activities (SOBDA) Questionnaire in Participants With Chronic Obstructive Pulmonary Disease (COPD) Assessed as Cronbach's Alpha Value|Cronbach’s alpha (CA) is a measure of the IC of the 13-item SOBDA questionnaire (completed via electronic diary by a sample of participants). It is the ratio of the variance (var.) of the sum of the individual scores and the var. of the total score. The var. of the sum of a group of independent variables is the sum of their var.; thus, if the variables are positively correlated, the var. of the sum will be increased. If the items making up the score are identical and so perfectly correlated, CA=1. If the items are independent, CA=0. Higher scores indicate a more reliable (precise) instrument.|Day 1 of the 2-week Run-in Period|Run-in Population: all participants who completed Visit 2 (Day 1 of Treatment Period), including those who were not randomized, were randomized but did not receive a dose of study medication, and those who were randomized and received study medication. Participants with a score for each SOBDA item on Day 1 of the 2-week Run-in Period were analyzed.||ratio of variance|||Number
846945|NCT00976248|Primary|Time to Next Therapy With Single Agent RAD001 Therapy in Previously Untreated WM||End of follow-up, an average of 18 months|13 participants were censored due to follow-up ending prior to new therapy initiation.||Months||Full Range|Median
846946|NCT00976248|Primary|Time to Progression With Single Agent RAD001 Therapy in Previously Untreated WM.|Progression is defined as a 25% increase in serum IgM from the lowest attained response value or progression of clinically significant disease related symptoms.|End of Treatment, an average of 16 months|13 participants were excluded from this analysis due to treatment and follow-up ending prior to progression.||Months||Full Range|Median
846947|NCT00976248|Primary|Overall Response Rate of RAD001 in Patients With Previously Untreated WM|"Overall Response = Complete Response + Near Complete Response + Very Good Partial Response + Partial Response + Minor Response Complete Response: resolution of all symptoms, normalization of serum IgM levels with complete disappearance of IgM paraprotein by immunofixation, and resolution of any adenopathy or splenomegaly. A near CR (nCR) is defined as fulfilling all CR criteria in the presence of positive immunofixation test for an IgM paraprotein.
Very Good Partial Response: > 90% reduction in serum IgM levels. Partial Response: > 50% reduction in serum IgM levels. Minor Response: 25-49% reduction in serum IgM levels Progressive Disease: greater than 25% increase in serum IgM level occurs from the lowest attained response value or progression of clinically significant disease related symptom(s).
Stable Disease: < 25% change in serum IgM levels, in the absence of new or increasing adenopathy or splenomegaly and/or other progressive signs or symptoms of WM"|End of Treatment, an average of 16 months|||participants|||Number
846948|NCT00973479|Secondary|Change From Baseline in Total Van Der Heijde Modified Sharp (vdH-S) Score at Week 24.|Total vdH-S score is sum of joint erosion score and joint-space narrowing (JSN) score. Joint erosion score summarizes erosion severity in 32 joints of hands and 12 joints of feet. Each joint scored from 0 (no erosion) to 5 (extensive loss of bone from more than one half of the articulating bone). Maximal erosion score is 280. JSN score summarizes severity of JSN in 30 joints of hands and 12 joints of feet. Assessment of JSN, including subluxation, is scored from 0 (normal) to 4 (bony ankylosis or complete luxation). Maximal JSN score is 168. Thus, the worst possible vdH-S score is 448.|Week 24|Intent-to-treat: all patients analyzed according to the treatment for which they were randomized.||Scores on a scale||Standard Deviation|Mean
847001|NCT00882557|Other Pre-specified|Time to Maximum Concentration|Sampling time at which maximum plasma concentration occurred, obtained directly from the experimental plasma concentration time data, without interpolation.|Up to 68 hours post dose|||Hours||Full Range|Median
847209|NCT00737672|Secondary|Clinical Success|The resumption of normal dialysis for at least one session following study treatment (Index Procedure).|Following Index Procedure|||Participants|||Number
846949|NCT00973479|Secondary|Proportion of Participants Who Achieved American College of Rheumatology (ACR) 50 Response at Week 24|An ACR 50 response is defined as a greater than or equal to 50 percent improvement from baseline in: 1. Swollen (66 joints) and tender (68 joints) joint counts; 2. greater than or equal to 50 percentage improvement in 3 of the following 5 assessments: a. Participant's assessment of pain by Visual Analog Scale (VAS) (0-10 cm) b. Participant's global assessment of disease activity by VAS (0-10 cm) c. Physician's global assessment of disease activity by VAS (0-10 cm) d. Participant's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C reactive protein.|Week 24|Intent-to-treat: all patients analyzed according to the treatment for which they were randomized.||Percentage of Participants|||Number
846950|NCT00973479|Secondary|Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Week 14|The HAQ is 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0 (no difficulty), to 3 (inability to perform a task in that area). HAQscore on a scale ranges from 0 (no disability) to 3 (completely disabled). Higher scores indicate worsening.|Week 14|Intent-to-treat: all patients analyzed according to the treatment for which they were randomized.||Scores on a scale||Standard Deviation|Mean
846951|NCT00973479|Secondary|Proportion of Participants With Moderate or Good Response in Disease Activity Index Score 28 (DAS28) Using C-reactive Protein (CRP) at Week 14|"DAS28 using CRP is an index to measure the disease activity in participants with rheumatoid arthritis combining tender joints (28 joints), swollen joints (28 joints), CRP, and participant’s global assessment of disease activity. The DAS28 score ranges from 0 (best) to 10 (worst). DAS28 score above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity. Higher scores indicate worsening. A decrease in DAS28 score >1.2 is being referred to as a good response and a decrease of 0.6-1.2 as a moderate response."|Week 14|Intent-to-treat: all patients analyzed according to the treatment for which they were randomized.||Percentage of Participants|||Number
846952|NCT00973479|Primary|Proportion of Participants With an American College of Rheumatology (ACR) 20 Response at Week 14|An ACR 20 response is defined as a greater than or equal to 20 percent improvement from baseline in: 1. Swollen (66 joints) and tender (68 joints) joint counts; 2. greater than or equal to 20 percentage improvement in at least 3 of the following 5 assessments: a. Participant's assessment of pain by Visual Analog Scale (VAS), (0 [no pain] to 10 [worst pain]) b. Participant's global assessment of disease activity by VAS c. Physician's global assessment of disease activity by VAS d. Participant's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C-reactive protein.|Week 14|Intent-to-treat: all patients analyzed according to the treatment for which they were randomized.||Percentage of Participants|||Number
846958|NCT00965458|Secondary|Hemoglobin A1c|Glycosylated hemoglobin (HbA1c) is a measure of the average plasma concentration of blood sugar (glucose) over the previous three months and measures the level of optimal management of underlying disease. An HbA1c level of 5.6% or less is considered normal. HbA1c levels of 6.5% or higher is typical for individuals with Type 1 Diabetes Mellitus (T1DM). The closer HbA1c levels are to normal, the better controlled the disease is.|Baseline (Pre-treatment initiation), Week 52, and Week 104|Intent-to-treat||HgbA1c percent (%)||Standard Deviation|Mean
846959|NCT00965458|Secondary|Major Hypoglycemic Events Occurring From Randomization|Major hypoglycemic events are defined as a glucose concentration <55 mg/dL (grades 2-5, NCI-CTCAE version 3.0), or clinically: involving seizure(s) or involving loss of consciousness (coma), or requiring assistance from another individual in order to recover.|Baseline to Week 52 and Week 52 to Week 104|Intent-to-treat||Major Hypoglycemic Events|||Number
846960|NCT00965458|Secondary|Insulin Use in Units Per Kilogram Body Weight Per Day|The need to use insulin is an indication that the body is not producing enough endogenous insulin. Higher amounts of insulin use indicate higher disease activity.|Baseline (Pre-treatment initiation), Week 52, and Week 104|Intent-to-treat||Units per day divided by weight in kg||Standard Deviation|Mean
846961|NCT00965458|Secondary|2-Hour C-peptide Area Under the Curve (AUC) Result in Response to Standardized Mixed Meal Tolerance Test (MMTT)|C-peptide is a substance released by the pancreas into the bloodstream in equal amounts to insulin and reflects how much insulin pancreatic beta cells are making. The standardized MMTT evaluates whether beta cells are producing endogenous insulin. The MMTT was performed in the morning and blood samples for C-peptide collected at baseline (pre-meal) and 15, 30, 60, 90, 120, 150, 180, 210,and 240 minutes post-meal. Results of the stimulated 2-hour (e.g., 120 minutes) post-meal C-peptide AUC are provided. Larger numbers are preferable (better) in these AUC results: more insulin being produced reflects less severe disease. C-peptide levels in the serum (e.g., AUC following a standardized MMTT) compared to control group at 1 year post treatment initiation for the evaluation of investigational products intended to preserve endogenous beta-cell function in T1DM trials is recognized by the Center for Drug Evaluation and Research (CDER) at the FDA as a valid efficacy primary endpoint.|Baseline (Pre-treatment initiation), Week 52, and Week 104|Intent-to-treat||pmol/mL||Standard Deviation|Mean
846962|NCT00965458|Secondary|4-Hour C-peptide Area Under the Curve (AUC) Result in Response to Standardized Mixed Meal Tolerance Test (MMTT)|C-peptide is a substance released by the pancreas into the bloodstream in equal amounts to insulin and reflects how much insulin pancreatic beta cells are making. The standardized MMTT evaluates whether beta cells are producing endogenous insulin. The MMTT was performed in the morning and blood samples for C-peptide collected at baseline (pre-meal) and 15, 30, 60, 90, 120, 150, 180, 210,and 240 minutes post-meal. Results of the stimulated 2-hour (e.g., 120 minutes) post-meal C-peptide AUC are provided. Larger numbers are preferable (better) in these AUC results: more insulin being produced reflects less severe disease. C-peptide levels in the serum (e.g., AUC following a standardized MMTT) compared to control group at 1 year post treatment initiation for the evaluation of investigational products intended to preserve endogenous beta-cell function in T1DM trials is recognized by the Center for Drug Evaluation and Research (CDER) at the FDA as a valid efficacy primary endpoint.|Baseline (Pre-treatment initiation), Week 52, and Week 104|Intent-to-treat||pmol/mL||Standard Deviation|Mean
846963|NCT00965458|Primary|2-Hour C-peptide Area Under the Curve (AUC) Result in Response to Standardized Mixed Meal Tolerance Test (MMTT)|C-peptide is a substance released by the pancreas into the bloodstream in equal amounts to insulin and reflects how much insulin pancreatic beta cells are making. The standardized MMTT evaluates whether beta cells are producing endogenous insulin. The MMTT was performed in the morning and blood samples for C-peptide collected at baseline (pre-meal) and 15, 30, 60, 90, 120, 150, 180, 210,and 240 minutes post-meal. Results of the stimulated 2-hour (e.g., 120 minutes) post-meal C-peptide AUC are provided. Larger numbers are preferable (better) in these AUC results: more insulin being produced reflects less severe disease. C-peptide levels in the serum (e.g., AUC following a standardized MMTT) compared to control group at 1 year post treatment initiation for the evaluation of investigational products intended to preserve endogenous beta-cell function in T1DM trials is recognized by the Center for Drug Evaluation and Research (CDER) at the FDA as a valid efficacy primary endpoint.|Baseline (pre-treatment initiation), Week 52|Intent-to-treat||pmol/mL||Standard Deviation|Mean
846964|NCT00952341|Secondary|Time to First Vomiting Episode in Cycle 1|Time from administration of chemotherapy to first vomiting episode.|0 to 120 hours|Full Analysis Set (FAS), defined as those who received chemotherapy, received a dose of study drug and had at least one post-treatment assessment. Any participant who did not have a response recorded for the assessment was excluded from the analysis.||Hours||Standard Error|Mean
846965|NCT00952341|Secondary|Proportion of Participants With No Impact on Daily Life in Cycle 1|"The Functional Living Index-Emesis is a self-administered, validated emesis & nausea-specific questionnaire. Participants completed the questionnaire 5 days post chemotherapy. It had 9 questions each on nausea and vomiting. No impact of chemotherapy-induced nausea & vomiting (CINV) on daily life was defined as an average item score of >6 on the 7-point scale (i.e., >108 total score). The scale was in the opposite direction for questions 3, 6, 11, 15 & 18. For each question: score ranged from 1 (worst) to 7 (best, i.e., no CINV). Total score range was 7 (worst) to 126 (best)."|0 to 120 hours|Full Analysis Set (FAS), defined as those who received chemotherapy, received a dose of study drug and had at least one post-treatment assessment. Any participant who did not have a response recorded for the assessment was excluded from the analysis.||Proportion of participants|||Number
846966|NCT00952341|Secondary|Proportion of Participants With No Vomiting in the Delayed Phase of Cycle 1|Delayed Phase was defined as 25 to 120 hours following initiation of chemotherapy|25 to 120 hours|Full Analysis Set (FAS), defined as those who received chemotherapy, received a dose of study drug and had at least one post-treatment assessment. Any participant who did not have a response recorded for the assessment was excluded from the analysis.||Proportion of participants|||Number
846967|NCT00952341|Secondary|Proportion of Participants With No Vomiting in the Acute Phase of Cycle 1|Acute Phase was defined as 0 to 24 hours following initiation of chemotherapy.|0 to 24 hours|Full Analysis Set (FAS), defined as those who received chemotherapy, received a dose of study drug and had at least one post-treatment assessment. Any participant who did not have a response recorded for the assessment was excluded from the analysis.||Proportion of participants|||Number
846968|NCT00952341|Secondary|Proportion of Participants With No Vomiting in the Overall Phase of Cycle 1|"Overall Phase was defined as 0 to 120 hours following initiation of chemotherapy.
No vomiting was defined as no vomiting or retching or dry heaves (included participants who received rescue therapy)."|0 to 120 hours|Full Analysis Set (FAS), defined as those who received chemotherapy, received a dose of study drug and had at least one post-treatment assessment. Any participant who did not have a response recorded for the assessment was excluded from the analysis.||Proportion of participants|||Number
846969|NCT00952341|Secondary|Proportion of Participants With Complete Response in the Delayed Phase of Cycle 1|"Delayed phase was defined as 25 to 120 hours following initiation of chemotherapy.
Complete response was defined as no vomiting with no rescue therapy."|25 to 120 hours|Full Analysis Set (FAS), defined as those who received chemotherapy, received a dose of study drug and had at least one post-treatment assessment. Any participant who did not have a response recorded for the assessment was excluded from the analysis.||Proportion of participants|||Number
847070|NCT00819390|Secondary|HIV-1 RNA Copies/mL at Week 12 for On-ART Participants|Results reported are for HIV-1 RNA at week 12 for on-ART participants.|At week 12|Analysis is based on all on-ART participants with HIV-1 RNA data at week 12.||participants|||Number
847229|NCT00734539|Secondary|Chronic Lung Disease||36 weeks corrected gestational age|Modified intent-to-treat; only subjects who received at least one dose of study drug.||participants|||Number
846971|NCT00952341|Primary|Proportion of Participants With Complete Response 120 Hours Following Initiation of High-dose Cisplatin Chemotherapy in the Overall Phase of Cycle 1|"Overall phase was defined as 0 to 120 hours following initiation of chemotherapy.
Complete response was defined as no vomiting with no rescue therapy."|0 to 120 hours|Full Analysis Set (FAS), defined as those who received chemotherapy, received a dose of study drug and had at least one post-treatment assessment. Any participant who did not have a response recorded for the assessment was excluded from the analysis.||Proportion of participants|||Number
846972|NCT00941330|Secondary|Response Rate by Imaging|"Arm A and recurrence score ≤10: Patients will have radiologic assessment of response to exemestane by clinical examination every 4 weeks and by radiologic assessment every 2 months. Once maximal response has been achieved (stable disease for 2 months after at least 4 months of treatment by radiologic assessment) or when 12 months of therapy has been given patients will proceed to surgery.
Arm B: Patients will be assessed for surgery after 6 cycles of docetaxel and cytoxan (TC) (18 weeks).
On arm A and recurrence score ≤10 patients will be reassessed for surgery once maximal radiologic response is achieved.
On arm B, patients will be reassessed for surgery after 6 cycles of TC (18 weeks).
Radiographic images were analyzed by a breast radiologist who looked at preoperative and postoperative breast mass imaging. If mass was smaller/less extensive, it was considered improved."|Every 2 months up to 3 years|Data were not available for 5 patients (4 withdrew and 1 did not have surgery).||Participants|||Count of Participants
846973|NCT00941330|Primary|Pathologic Complete Response|"Patients must have measurable disease by clinical examination.
Pathologic complete response (pCR): Absence of invasive breast cancer in the breast (mastectomy or lumpectomy) specimen at the time of definitive surgery. Presence of in situ cancer alone will be considered a pCR but may be recorded separately.
If pathologic stage was the same as clinical stage, it was called stable; if it was higher, upstaged (worse outcome); if lower, downstaged (better outcome). Pathologic stage was determined by Emory board-certified pathologists."|At time of definitive surgery|One patient in Arm B did not have surgery.||Participants|||Count of Participants
846978|NCT00909870|Other Pre-specified|Complete Healing by Week 16: Ulcers <= 12 Months Duration||16 weeks|Pre-specified Subgroup of the Intent-to-Treat Population||participants|||Number
846979|NCT00909870|Secondary|Time-to-Complete Healing|Kaplan-Meier survival analysis of the time to achieve median (50%) Complete Healing response in each treatment group.|From Week 0 visit to date subject's completely healed ulcer is 1st recorded as healed. If subject’s ulcer not healed at 16 weeks, the “time until CH” was censored at 112 days.|Intent-to-Treat population||days||Inter-Quartile Range|Median
846980|NCT00909870|Primary|Complete Healing of the Study Ulcer by Week 16.||16 weeks|Intent-to-Treat population||participants|||Number
846989|NCT00891839|Secondary|Shifts in Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status|"The ECOG scale is:
Grade 0: Fully active, able to carry on all pre-disease activities without restriction;
Grade 1: Restricted in physically strenuous activity, ambulatory and able to carry out work of a light nature;
Grade 2: Ambulatory and capable of all self-care but unable to work. Up and about more than 50% of waking hours;
Grade 3: Capable of only limited self-care, confined to bed or chair > 50% of waking hours;
Grade 4: Completely disabled. Cannot carry on any self-care. Confined to bed or Chair.
The shift table compares baseline ECOG scores to the ECOG scores as of the last treatment visit."|Day 0 (baseline) up to Month 8|Safety population. One participant dropped out prior to obtaining a post-treatment ECOG evaluation.||participants|||Number
846990|NCT00891839|Secondary|Shifts in Baseline to Post-Treatment in Positron Emission Tomography (PET)|Participants had a whole-body PET at baseline and at the end of cycle 6 or the end-of-treatment visit. Negative PET refers to PET results showing no abnormal lymph nodes; conversely, positive PET refers to PET results showing abnormal lymph nodes.|Baseline (Days -30 to 0), post treatment (up to Month 9, 30 days following completion of therapy)|Safety population of participants with PET data||participants|||Number
846991|NCT00891839|Secondary|Kaplan-Meier Estimate for Overall Survival|Overall survival is defined as the time from first exposure to study medication to death, or to last date from adverse events, concomitant medications, vital signs, lost to follow-up, or last known alive, for overall survival censoring date.|Day 1 up to Month 57|Safety population||months||95% Confidence Interval|Median
846992|NCT00891839|Secondary|Kaplan-Meier Estimate for Progression-Free Survival|Progression-free survival is defined as the time from first exposure to study medication to disease progression or relapse, or death due to any cause. Progression is defined using the 2007 International Working Group criteria, as any new lesion or increase by at least 50% of previously involved sites from nadir.|Day 1 up to Month 45|Safety population||months||95% Confidence Interval|Median
846993|NCT00891839|Secondary|Kaplan-Meier Estimate for Duration of Response|Duration of response is defined as the time between the date of the first response to date of progression or death. Response is determined on the basis of the 2007 IWG criteria. A complete response is a complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A partial response is at least a 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase should be observed in the size of other nodes, liver or spleen, and no new sites of disease should be observed.|Day 1 up to Month 43|Safety population of participants who had a response.||months||95% Confidence Interval|Median
846994|NCT00891839|Primary|Overall Response Rate (Complete Response + Partial Response) at the End of Cycles 3 and 6 Using the 2007 International Working Group Criteria|"The International Working Group (IWG) criteria (Cheson et al 2007) for a complete response is a complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A partial response is at least a 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase should be observed in the size of other nodes, liver or spleen, and no new sites of disease should be observed.
95% CIs are calculated using binomial exact method."|Month 3 (end of cycle 3), Month 6 (end of cycle 6)|Safety population consisting of all participants treated with at least 1 dose of bendamustine HCL.||percentage of participants||95% Confidence Interval|Number
846995|NCT00887510|Secondary|Change in Total Adiponectin Level After Addition of Trandolapril to HCTZ Compared With Change in Adiponectin After Addition of HCTZ to Trandolapril|"Comparing the change in adiponectin: rand 1 visit4-visit 3 with rand 2 visit 3-2.
This allows for understanding the effects of addition of trandolapril to 12 weeks of HCTZ compared with addition of HCTZ to 12 weeks of trandolapril."|Over the course of 18 weeks|||mcg/ml||Standard Deviation|Mean
846996|NCT00887510|Primary|Change in Oral Glucose Tolerance Test (OGTT) Area Under Curve (AUC) After Addition of Trandolapril to Hydrochlorothiazide (HCTZ) Compared With Change in OGTT AUC After Addition of HCTZ to Trandolapril|Comparing the change in OGTT AUC rand 1 visit4-visit 3 with rand 2 visit 3-2. This allows for understanding the effects of addition of trandolapril to 12 weeks of HCTZ compared with addition of HCTZ to 12 weeks of trandolapril. This is the primary outcome of the study.|OGTT AUC measured over 120 minutes after receiving study intervention for 18-24 weeks.|||minutes*mg/dl||Standard Deviation|Mean
846997|NCT00882557|Secondary|Treatment-emergent Adverse Events|Safety was monitored throughout the study, including observation and reports of AEs as well as changes in physical findings, vital signs, ECGs, and laboratory tests.|Up to 9 days after the last dose of study drug administration (Day 13 to Day 17 for those dosed on Day 8 and Day 20 to Day 24 for those dosed on Day 15).|Safety population, defined as all subjects who received at least one dose of daptomycin||participants|||Number
846998|NCT00882557|Other Pre-specified|Volume of Distribution|Volume of distribution at steady state (mL) calculated as the product of clearance and mean residence time.|Up to 68 hours post dose|||mL/kg||Full Range|Median
846999|NCT00882557|Other Pre-specified|Clearance of Daptomycin|Plasma clearance is dose (µg) divided by area under the concentration versus time curve from time 0 to last quantifiable concentration time.|Up to 68 hours post dose|PK Population - defined as all subjects who received both doses of daptomycin||mL/hr/kg||Full Range|Median
847002|NCT00882557|Other Pre-specified|Maximum Plasma Concentration|Maximum plasma concentration over the entire sampling phase directly obtained from the experimental plasma concentration time data, without interpolation.|Within 30 minutes prior to the start of the infusion, mid-infusion, and end of the infusion; at 1, 2, 4, 6, 9, 24, and 48 hours after the end of the infusion; and just prior to the next hemodialysis session (i.e., 68 hours post-infusion)|PK Population - defined as all subjects who received both doses of daptomycin||ug/mL||Full Range|Median
847003|NCT00882557|Primary|Evaluation of Area Under the Curve From Time 0 to Infinity|Area under the plasma concentration versus time curve from time 0 to infinity for daptomycin doses|Within 30 minutes prior to the start of the infusion, mid-infusion, and end of the infusion; at 1, 2, 4, 6, 9, 24, and 48 hours after the end of the infusion; and just prior to the next hemodialysis session (i.e., 68 hours post-infusion)|The primary endpoints are measured on the PK population, defined as all subjects who received both the 6 mg/kg dose and 9 mg/kg dose||hr*ug/mL||Full Range|Median
847004|NCT00880698|Secondary|Number of Participants Classified at Screening or Entry as HIV-1 Uninfected, and Acquiring HIV-1 Infection on Study|HIV tests were done at screening, entry and the last study visit after the third vaccination. Any participants classified as HIV-1 uninfected at screening or entry but HIV-1 infected at their last study visit would be classified as acquiring HIV-1 infection during the study|From study entry until at least 42 days after third vaccination|Includes HIV-1 uninfected participants 'as-randomized' with an HIV test at entry and either 2 or 6 weeks after the third vaccination (or after the time point at which they would have received the third vaccination if they did not receive all three doses)||participants|||Number
847005|NCT00880698|Secondary|Change in CD4 Count From Entry to Last Study Visit in HIV-1 Infected Participants|Change calculated as value at last study visit minus value closest to and before randomization date|At entry and 42 days after third vaccination or last study visit with CD4 measurement|Includes HIV-infected participants 'as randomized' with a CD4 count measurement prior to first vaccination and at their last study visit||cells/mm^3||Standard Deviation|Mean
847006|NCT00880698|Secondary|Change in CD4 Percent From Entry to Last Study Visit in HIV-1 Infected Participants|Change calculated as value at last study visit minus value closest to and before randomization date|At entry and 42 days after third vaccination or last study visit with CD4 measurement|Includes HIV-1 infected participants 'as-randomized' with a CD4 percent measurement prior to first vaccination and at last study visit||Percentage of lymphocytes||Standard Deviation|Mean
847007|NCT00880698|Secondary|Percentage of HIV-1 Infected Participants With HIV-1 RNA <= 400 Copies/ml|Percentage of HIV-1 infected participants with HIV-1 RNA <= 400 copies/ml at last study visit|42 days after third vaccination or last study visit with an HIV-1 RNA measurement|Includes HIV-infected participants 'as-randomized' with an HIV-1 RNA measurement at their last study visit||Percentage of participants|||Number
847008|NCT00880698|Secondary|Number of Participants With Fecal Shedding of RotaTeq Strains After Each Vaccination|Number of participants with at least one positive enzyme immuno assay (EIA) rotavirus antigen test, positive fluorescent focal assay, and specific for rotavirus gene 6 which codes for the VP6 protein after each vaccination.|At entry, days 7, 14, 21 and 42 days after first dose, and at days 7 and 21 after the second and third doses|All participants 'as randomized'||participants|||Number
847009|NCT00880698|Primary|Percentage of Participants Classified as Responders as Measured by Serum Anti-rotavirus IgA ELISA (IgA) and Serum Neutralizing Antibodies (SNA) G1, G2, G3, G4 and P1.|Percentage of participants who experienced >=3-fold increases from prior to the first vaccination to at least 14 days after the third vaccination in Iga, SNA G1, SNA G2, SNA G3, SNA G4 and SNA P1.|Prior to first vaccination and at least 14 days after third vaccination|Only participants in the per-protocol population (received all 3 as-randomized vaccinations within recommended windows) and with measurements prior to the first vaccination and at least 11 days after the third vaccination and whose levels at the entry time point were less than one third of the upper limit of detection of the assay were included.||Percentage of participants||95% Confidence Interval|Number
847010|NCT00880698|Primary|Percentage of Participants Developing New Grade >=3 Adverse Events|Percentage of participants developing new grade >=3 adverse events (abnormal laboratory values (hematology and chemistry), signs, symptoms and diagnoses) not present at the time of the first vaccination. Adverse events were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (Version 1.0, December 2004, Clarification August 2009).|From study entry until at least 42 days after third vaccination|Participants classified 'as'randomized'. Includes all follow-up on participants unblinded during the study and found to be on RotaTeq. Follow-up on participants unblinded during the study and found to be on placebo censored at the time of their last study vaccination.||Percentage of participants||95% Confidence Interval|Number
856774|NCT00571324|Secondary|Mean Plasma Intact Glucagon-Like Peptide-1 (GLP-1) Area Under the Curve (AUC 0-6h)|To examine the effect of Exendin-(9-39) on plasma intact glucagon-like Peptide-1 (GLP-1) levels, samples were collected at various time points before and during the infusion [Exendin-(9-39) or vehicle] including: 60 minutes before the start of the infusion, again at the start of the infusion (Time 0), and then every 20 minutes until 6 hours after the start of the infusion. Using this information, the mean intact GLP-1 area under the curve (AUC) from the start of the infusion to the end of the infusion (360 minutes) was calculated for each both Exendin-(9-39) and vehicle and compared.|6 hours|Subjects served as their own control for comparison between effects of Exendin-(9-39) and the normal saline vehicle.||pmol*min/L||Standard Error|Mean
856775|NCT00571324|Secondary|Mean Plasma Glucagon Area Under the Curve (AUC 0-6h)|To examine the effect of Exendin-(9-39) on plasma glucagon levels, samples were collected at various time points before and during the infusion [Exendin-(9-39) or vehicle] including: 60 minutes before the start of the infusion, again at the start of the infusion (Time 0), and then every 20 minutes until 6 hours after the start of the infusion. Using this information, the mean plasma glucagon area under the curve (AUC) from the start of the infusion to the end of the infusion (360 minutes) was calculated for each both Exendin-(9-39) and vehicle and compared.|6 hours|Subjects served as their own control for comparison between effects of Exendin-(9-39) and the normal saline vehicle.||pg*min/dL||Standard Error|Mean
856952|NCT02542072|Secondary|Corneal Coverage|"Investigator assessment of corneal coverage for comfilcon A and samfilcon A lenes.
Yes = coverage at all times or No = coverage incomplete"|Baseline Visit, 2 weeks follow-up, 4-weeks follow-up|||percentage of eyes|Eyes||Number
847071|NCT00819390|Secondary|HIV-1 RNA Copies/mL at Study Entry for On-ART Participants|Results reported are for HIV-1 RNA at study entry for on-ART participants.|At Entry|Analysis is based on all on-ART participants with HIV-1 RNA data at entry.||participants|||Number
847072|NCT00819390|Secondary|HIV-1 RNA Copies/mL at Weeks 12 and 24 for Off-ART Participants|Results reported are for HIV-1 RNA (copies/mL) at week 12 and week 24 for off-ART participants.|At weeks 12 and 24|Analysis is based on all off-ART participants with HIV-1 RNA data at week 12 and week 24.||log10 copies/mL||Inter-Quartile Range|Median
847028|NCT00874120|Primary|Average Systolic Blood Pressure (SBP) Readings for a 5-hour Range Around the Time of Maximum Concentration (Tmax).|Five hour (hr) range around the Tmax was defined as approximately 2 hours before to approximately 2 hours after the Tmax, including Tmax. The parameters will be compared between active drug and placebo using analysis of variance (ANOVA). The 95% 2-sided Confidence Interval (CI) on the difference between treatments will also be presented.|24 hours after final dose of each 7-day treatment period.|The per-protocol population included 100 participants who completed both treatment periods and have 24-hour Ambulatory Blood Pressure Monitoring (ABPM) data for SBP measurements for each study drug, 46 participants who received phenylephrine followed by placebo and 54 participants who received placebo followed by phenylephrine.||mmHg||Standard Deviation|Mean
847029|NCT00868140|Secondary|Matsuda Index|Whole body insulin sensitivity as determined by the Matsuda Index|6 months|||units on a scale||Standard Error|Mean
847030|NCT00868140|Primary|Fasting Serum Insulin (uIU/ml)|Fasting serum insulin (uIU.min/ml) measured at 0, 60 and 120 minutes of a 2 hour OGTT following 6 months treatment with either pioglitazone or placebo|6 months|||uIU.min/ml||Standard Error|Mean
847031|NCT00868140|Primary|Fasting Serum Insulin|Fasting serum insulin (uIU.min/ml) measured at 0, 60 and 120 minutes of a 2 hour OGTT before treatment with either pioglitazone or placebo|baseline|||uIU.min/ml||Standard Error|Mean
847032|NCT00868140|Primary|AUC DCI-IPG (%/Min)|Change in the Area Under the Curve DCI-IPG measurements in blood samples taken at 15 minute intervals during the 2 hour OGTT following 6 months of treatment with pioglitazone or placebo. Values reported as a percentage of bioactivity measured at time 0. Negative values indicate a decrease relative to the time 0 measurement.|6 months|||% bioactivity at time 0 of OGTT||Standard Error|Mean
847033|NCT00868140|Secondary|Matsuda Index|"Whole body insulin sensitivity as determined by the Matsuda Index as calculated using the following formula:
10,000 divided by the square root of (FPI* FPG) * (xGPC* xIPC) Where FPI is fasting plasma insulin expressed as uU/ml, FPG is fasting plasma glucose expressed as mg/dL, xGPC is mean plasma glucose concentration after the load and xIPC is the mean insulin concentration after the load.
Values calculated on samples taken at 0, 30, 60, 90 and 120 minutes of a 2 hour OGTT. Values typically range from 0 to 12 units with higher scores indicating better insulin sensitivity. A value of 2.5 or less is indicative of insulin resistance."|Baseline|||units on a scale||Standard Error|Mean
847034|NCT00868140|Primary|AUC DCI-IPG (%/Min)|Change in the Area Under the Curve DCI-IPG measurements in blood samples taken at 15 minute intervals during the 2 hour OGTT before treatment with pioglitazone or placebo. Values reported as a percentage of bioactivity measured at time 0. Negative values indicate a decrease relative to the time 0 measurement.|Baseline|||% bioactivity at time 0 of OGTT||Standard Error|Mean
847035|NCT00856284|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 104|The change from Baseline to Week 104 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound). The least squares (LS) means are from an analysis of covariance (ANCOVA) model with treatment, study schedule, and geographic region as class variables, and Baseline metformin dose and Baseline HbA1c as covariates.|Baseline and Week 104|The Per-protocol set included all randomized patients who took at least 1 dose of double-blind study drug, with a Baseline assessment and at least 1 post-baseline assessment for that variable and who had no major protocol violations. Last observation carried forward was used (LOCF).||percentage glycosylated hemoglobin||Standard Error|Least Squares Mean
847036|NCT00856284|Secondary|Change From Baseline in Body Weight Over Time|LS Means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and Baseline weight and Baseline metformin dose as covariates.|Baseline and Weeks 12, 26, 39, 52, 65, 78, 91, and 104.|Full analysis set, LOCF was used.||kg||Standard Error|Least Squares Mean
847037|NCT00856284|Secondary|Percentage of Participants With Glycosylated Hemoglobin Less Than or Equal to 7.0%|Percentage of participants with HbA1c ≤ 7.0% at Weeks 26, 52, 78, and 104. Participants who did not complete the scheduled Week 104 visit were assessed based on their response at the time of discontinuation.|Weeks 26, 52, 78, and 104.|Full analysis set. Participants who did not complete the scheduled Week 26, Week 52, Week 78 or Week 104 visit were assessed based on their response at the time of discontinuation.||percentage of participants|||Number
847038|NCT00856284|Secondary|Percentage of Participants With Glycosylated Hemoglobin Less Than or Equal to 6.5%|The percentage of participants with HbA1c less than or equal to 6.5% at Weeks 26, 52, 78, and 104. Participants who did not complete the scheduled Week 104 visit were assessed based on their response at the time of discontinuation.|Weeks 26, 52, 78, and 104.|Full analysis set. Participants who did not complete the scheduled Week 26, Week 52, Week 78 or Week 104 visit were assessed based on their response at the time of discontinuation.||percentage of participants|||Number
847039|NCT00856284|Secondary|Change From Baseline in Fasting Plasma Glucose Over Time|The change from Baseline in fasting plasma glucose (FPG) was assessed at Weeks 2, 4, 8, 12, 16, 20, 26, 39, 52, 65, 78, 91, and 104. LS means are from an ANCOVA model with treatment, study schedule, and geographic region as class variables, and Baseline FPG and Baseline metformin dose as covariates.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 26, 39, 52, 65, 78, 91, and 104.|Full analysis set, which included all randomized patients who received at least 1 dose of double-blind study drug who had a Baseline assessment and at least 1 post-baseline assessment for FPG. LOCF was used.||mg/dL||Standard Error|Least Squares Mean
847040|NCT00856284|Secondary|Change From Baseline in Glycosylated Hemoglobin at Other Time Points|The change from Baseline over time in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound). LS means are from an ANCOVA model with treatment, study schedule, and geographic region as class variables, and Baseline metformin dose and Baseline HbA1c as covariates.|Baseline and Weeks 4, 8, 12, 16, 20, 26, 39, 65, 78, and 91.|Per-protocol set; LOCF was used.||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
847041|NCT00856284|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 52|The change from Baseline to Week 52 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound). The least squares (LS) means are from an analysis of covariance (ANCOVA) model with treatment, study schedule, and geographic region as class variables, and Baseline metformin dose and Baseline HbA1c as covariates.|Baseline and Week 52|The Per-protocol set included all randomized patients who took at least 1 dose of double-blind study drug, with a Baseline assessment and at least 1 post-baseline assessment for that variable and who had no major protocol violations. Last observation carried forward (LOCF) was used.||percentage glycosylated hemoglobin||Standard Error|Least Squares Mean
847042|NCT00847912|Primary|Hazard Ratio for Surgically Treated KC||date of randomization to last visit before end of study follow up (6/30/2013), assessed up to four years|||participants|||Number
847043|NCT00847912|Primary|The Time to Diagnosis of the First Keratinocyte Carcinoma (KC) on the Face or Ears for Which Surgery is Performed|Diagnosis of the first Primary Basil Cell Carcinoma (BCC) or primary Squamous Cell Carcinoma (SCC) on the face or ears that was removed surgically.|From randomization to last visit prior to end of study date (6/30/2013), assessed up to four years|||years||95% Confidence Interval|Median
847044|NCT00837434|Secondary|Percentage of Participants Meeting ACR50 Response Criteria at Week 24|"The American College of Rheumatology (ACR) 50 Responder Index is defined as someone who achieved at least 50% improvement in the tender and swollen 28-joint count, and 50% improvement in at least three of the following 5 measures:
Patient's pain assessment (Visual Analogue Scale (VAS) 100 mm)
Patient's global assessment of disease activity (VAS 100 mm)
Physician's global assessment of disease activity (VAS 100 mm)
Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)
Acute phase reactant (CRP).
Participants with measurements for designated time points were included in the analysis."|Week 24|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either etanercept or adalimumab. Data were not available for five participants who received Etanercept.||percentage of participants|||Number
847045|NCT00837434|Secondary|Percentage of Participants Meeting ACR50 Response Criteria at Week 12|"The American College of Rheumatology (ACR) 50 Responder Index is defined as someone who achieved at least 50% improvement in the tender and swollen 28-joint count, and 50% improvement in at least three of the following 5 measures:
Patient's pain assessment (Visual Analogue Scale (VAS) 100 mm)
Patient's global assessment of disease activity (VAS 100 mm)
Physician's global assessment of disease activity (VAS 100 mm)
Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)
Acute phase reactant (CRP).
Participants with measurements for designated time points were included in the analysis."|Week 12|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either etanercept or adalimumab. Data were not available for two participants who received Etanercept.||percentage of participants|||Number
847046|NCT00837434|Secondary|Percentage of Participants Meeting ACR20 Response Criteria at Week 24|"The American College of Rheumatology (ACR) 20 Responder Index is defined as someone who achieved at least 20% improvement in the tender and swollen 28-joint count, and 20% improvement in at least three of the following 5 measures:
Patient's pain assessment (Visual Analogue Scale (VAS) 100 mm)
Patient's global assessment of disease activity (VAS 100 mm)
Physician's global assessment of disease activity (VAS 100 mm)
Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)
Acute phase reactant (CRP).
Participants with measurements for designated time points were included in the analysis."|Week 24|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either etanercept or adalimumab. Data were not available for five participants who received Etanercept.||percentage of participants|||Number
847047|NCT00837434|Secondary|Percentage of Participants Meeting ACR20 Response Criteria at Week 12|"The American College of Rheumatology (ACR) 20 Responder Index is defined as someone who achieved at least 20% improvement in the tender and swollen 28-joint count, and 20% improvement in at least three of the following 5 measures:
Patient's pain assessment (Visual Analogue Scale (VAS) 100 mm)
Patient's global assessment of disease activity (VAS 100 mm)
Physician's global assessment of disease activity (VAS 100 mm)
Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)
Acute phase reactant (CRP).
Participants with measurements for designated time points were included in the analysis."|Week 12|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either etanercept or adalimumab. Data were not available for two participants who received Etanercept.||percentage of participants|||Number
847048|NCT00837434|Secondary|"Percentage of Participants Fulfilling DAS-28-CRP Good or Moderate Response Criteria at Week 24"|Good responders had: change in DAS28-CRP (Baseline-Week 24) > 1.2 and the Week 24 DAS-CRP score was <= 3.2. If the conditions for non-response* or good response were not met then the DAS28-CRP response was considered moderate.[*Non-responders had any of the 4 conditions: change in DAS28-CRP (Baseline –Week 24) <0.6; 0.6 <\= change in DAS28-CRP ( Baseline-Week 24) < 1.2 with Week 24 DAS28-CRP score > 5.1 ; a flare that required prednisone > 10 mg/day (or equivalent) beyond Week 8 or the inability to taper prednisone to <= 10 mg/day by Week 8; or the participant required prednisone > 20 mg/day at any time point]. Participants with measurements for designated time points were included in the analysis.|Week 24|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either etanercept or adalimumab. Data were not available for five participants who received Etanercept.||percentage of participants|||Number
847073|NCT00819390|Secondary|HIV-1 RNA Copies/mL at Study Entry for Off-ART Participants|Results reported are for HIV-1 RNA (copies/mL) at study entry for off-ART participants.|At Entry|Analysis is based on all off-ART participants with HIV-1 RNA data at entry.||log10 copies/mL||Inter-Quartile Range|Median
847230|NCT00734539|Secondary|Focal Intestinal Perforation||prior to hospital discharge, up to 15 ½ months|Modified intent-to-treat; only subjects who received at least one dose of study drug.||participants|||Number
847049|NCT00837434|Secondary|Percentage of Participants Fulfilling DAS-28-CRP “Good or Moderate Response” Criteria at Week 12|Good responders: change in DAS28-CRP (Baseline-Week12) > 1.2 and Week 12 DAS-CRP score was <\= 3.2. If the conditions for non-response* or good response were not met, the DAS28-CRP response was considered moderate. Participants with measurements for designated time points were included in the analysis. [*Non-responders had any of 4 conditions: change in DAS28-CRP (Baseline –Week 12) <0.6; 0.6 <\= change in DAS28-CRP ( Baseline-Week 12) < 1.2 with Week 12 DAS28-CRP score > 5.1; a flare that required prednisone > 10 mg/day (or equivalent) beyond Week 8 or the inability to taper prednisone to <\= 10 mg/day by Week 8; or the participant required prednisone > 20 mg/day at any time point].|Week 12|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either etanercept or adalimumab. Data were not available for two participants who received Etanercept.||percentage of participants|||Number
847050|NCT00837434|Primary|Percentage of CD27+ Switched Memory B Cells at Week 12|Analysis of the steady state composition of the B cell compartment were performed using ex-vivo multicolor flow cytometry on Ficoll isolated peripheral blood mononuclear cells (PBMCs). CD27+ switched memory B cells are a subset of B cells and are assessed by flow cytometry. CD27+ switched memory B cells are expressed as a percent of B cells. Lower CD27+ memory B cells indicate a decrease in the generation of B cell memory which may be caused by blocking lymphotoxin (LT) and tumor necrosis factor (TNF) signaling.|Week 12|The Per Protocol population includes subjects with a baseline and week 12 (plus or minus 1 week) assessment that received at least 75% of the planned doses of either etanercept or adalimumab prior to week 12 and who did not have any serious protocol deviations.||Percentage of B Cells||Standard Deviation|Mean
847051|NCT00819390|Secondary|Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 24|Results reported are the week 24 percent activation levels of pDC and mDC.|At week 24|Analysis is based on all participants with assay data at week 24.||percentage of cells||Inter-Quartile Range|Median
847052|NCT00819390|Secondary|Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 12|Results reported are the week 12 percent activation levels of pDC and mDC.|At week 12|Analysis is based on all participants with assay data at week 12.||percentage of cells||Inter-Quartile Range|Median
847053|NCT00819390|Secondary|Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Baseline|Baseline percent activation levels of pDC were computed as the mean of pre-entry and entry percent activation levels of pDC. Similarly, baseline percent activation levels of mDC were computed as the mean of pre-entry and entry percent activation levels of mDC.|At pre-entry and entry|Analysis is based on all participants with assay data at pre-entry or entry.||percentage of cells||Inter-Quartile Range|Median
847054|NCT00819390|Secondary|Fasting Lipopolysaccharides (LPS) at Week 24|Results reported are the week 24 fasting LPS.|At week 24|Analysis is based on all participants with assay data at week 24.||pg/mL||Inter-Quartile Range|Median
847055|NCT00819390|Secondary|Fasting Lipopolysaccharides (LPS) at Week 12|Results reported are the week 12 fasting LPS.|At week 12|Analysis is based on all participants with assay data at week 12.||pg/mL||Inter-Quartile Range|Median
847056|NCT00819390|Secondary|Fasting Lipopolysaccharides (LPS) at Entry|Results reported are for entry fasting LPS.|At entry|Analysis is based on all participants with assay data at entry.||pg/mL||Inter-Quartile Range|Median
847057|NCT00819390|Secondary|Soluble CD14 (sCD14) at Week 24|Results reported are the week 24 sCD14.|At week 24|Analysis is based on all participants with assay data at week 24.||million pg/mL||Inter-Quartile Range|Median
847058|NCT00819390|Secondary|Soluble CD14 (sCD14) at Week 12|Results reported are the week 12 sCD14.|At week 12|Analysis is based on all participants with assay data at week 12.||million pg/mL||Inter-Quartile Range|Median
847059|NCT00819390|Secondary|Soluble CD14 (sCD14) at Baseline|Baseline sCD14 was computed as the mean of pre-entry and entry sCD14.|At pre-entry and entry|Analysis is based on all participants with assay data at pre-entry or entry.||million pg/mL||Inter-Quartile Range|Median
847060|NCT00819390|Secondary|IL-6, Soluble TNF-rI (sTNF-rI) and D-dimer at Week 24|Results reported are the week 24 IL-6, sTNF-rI and D-dimer.|At week 24|Analysis is based on all participants with assay data at week 24.||pg/mL||Inter-Quartile Range|Median
847061|NCT00819390|Secondary|IL-6, Soluble TNF-rI (sTNF-rI) and D-dimer at Week 12|Results reported are the week 12 IL-6, sTNF-rI and D-dimer.|At week 12|Analysis is based on all participants with assay data at week 12.||pg/mL||Inter-Quartile Range|Median
847062|NCT00819390|Secondary|IL-6, Soluble TNF-rI (sTNF-rI) and D-dimer at Baseline|Baseline IL-6, sTNF-rI and D-dimer were computed as the mean of pre-entry and entry IL-6, sTNF-rI and D-dimer, respectively.|At pre-entry and entry|Analysis is based on all participants with assay data at pre-entry or entry.||pg/mL||Inter-Quartile Range|Median
847063|NCT00819390|Secondary|Percent CD4 HLA-DR+/CD38+ at Week 24|Results reported are the week 24 percentage of CD4 expressing HLA-DR+/CD38+.|At Week 24|Analysis is based on all participants with assay data at week 24.||percent of CD4 expressing HLA-DR+/CD38+||Inter-Quartile Range|Median
847064|NCT00819390|Secondary|Percent CD4 HLA-DR+/CD38+ at Week 12|Results reported are the week 12 percentage of CD4 expressing HLA-DR+/CD38+.|At Week 12|Analysis is based on all participants with assay data at week 12.||percent of CD4 expressing HLA-DR+/CD38+||Inter-Quartile Range|Median
847065|NCT00819390|Secondary|Percent CD4 HLA-DR+/CD38+ at Baseline|Baseline CD4 HLA-DR+/CD38+ is computed as the mean of pre-entry and entry CD4 HLA-DR+/CD38+.|At pre-entry and entry|Analysis is based on all participants with assay data at pre-entry or entry.||percent of CD4 expressing HLA-DR+/CD38+||Inter-Quartile Range|Median
847066|NCT00819390|Secondary|Percent CD8 CD38+ at Week 24|Results reported are the week 24 percentage of CD8 expressing CD38+.|At Week 24|Analysis is based on all participants with assay data at week 24.||percent of CD8 expressing CD38+||Inter-Quartile Range|Median
847067|NCT00819390|Secondary|Percent CD8 CD38+ at Week 12|Results reported are the week 12 percentage of CD8 expressing CD38+.|At Week 12|Analysis is based on all participants with assay data at week 12.||percent of CD8 expressing CD38+||Inter-Quartile Range|Median
847068|NCT00819390|Secondary|Percent CD8 CD38+ at Baseline|Baseline CD8 CD38+ is computed as the mean of pre-entry and entry CD8 CD38+.|At pre-entry and entry|Analysis is based on all participants with assay data at pre-entry or entry.||percent of CD8 expressing CD38+||Inter-Quartile Range|Median
847069|NCT00819390|Secondary|HIV-1 RNA Copies/mL at Week 24 for On-ART Participants|Results reported are for HIV-1 RNA at week 24 for on-ART participants.|At week 24|Analysis is based on all on-ART participants with HIV-1 RNA data at week 24.||participants|||Number
847074|NCT00819390|Secondary|Number of Participants With Events Grade 3 or Higher|Events included signs and symptoms, laboratory abnormalities and/or clinical events grade 3 or higher which were described by site clinician blinded to the treatment arm as definitely or possibly related to the study treatment.|From start of study treatment to study completion at week 28|Analysis is based on all enrolled participants, off-ART and on-ART, who received study treatment.||participants|||Number
847075|NCT00819390|Secondary|Change in Total CD4 T Cell Count From Baseline to Week 12|Baseline CD4 count (mean of pre-entry and entry CD4 count) is subtracted from the mean of week 10 and week 12 CD4 count|At pre-entry, entry, weeks 10 and 12|Analysis used a modified as-treated approach, limited to participants with assay data at baseline and weeks 10 or 12, and with no break in study treatment for >=14 days. Off-ART analysis excluded participants who started ART. On-ART analysis excluded participants who stopped ART or had virologic rebound (confirmed HIV-1 RNA>1000 copies/mL).||cells/mm^3||Inter-Quartile Range|Median
847076|NCT00819390|Secondary|Change in Percent CD8 HLA-DR+/CD38+ From Baseline to Week 24 in Arm A and Arm C|The baseline percent CD8 HLA-DR+/CD38+ (mean of pre-entry and entry percent CD8 HLA-DR+/CD38+) was subtracted from the mean of week 22 and week 24 percent CD8 HLA-DR+/CD38+.|At Pre-entry, entry, Weeks 22 and 24|Analysis used a modified as-treated approach, limited to participants with assay data at baseline and weeks 22 or 24, and with no break in study treatment for >=14 days. Off-ART analysis excluded participants who started ART. On-ART analysis excluded participants who stopped ART or had virologic rebound (confirmed HIV-1 RNA>1000 copies/mL).||percent of CD8 expressing HLA-DR+/CD38+||Inter-Quartile Range|Median
847077|NCT00819390|Secondary|Change in Percent CD8 HLA-DR+/CD38+ From Week 12 to Week 24|The mean of week 10 and week 12 percent CD8 HLA-DR+/CD38+ is subtracted from the mean of the week 22 and week 24 percent CD8 HLA-DR+/CD38+|At Weeks 10, 12, 22 and 24|Analysis used a modified as-treated approach, limited to participants with assay data at weeks 10 or 12, and 22 or 24, and with no break in study treatment for >=14 days. Off-ART analysis excluded participants who started ART. On-ART analysis excluded participants who stopped ART or had virologic rebound (confirmed HIV-1 RNA>1000 copies/mL).||percent of CD8 expressing HLA-DR+/CD38+||Inter-Quartile Range|Median
847078|NCT00819390|Secondary|Change in Percent CD8 HLA-DR+/CD38+ From Start to End of the 12-week Chloroquine Treatment Period|For Arm A: Chloroquine then Placebo for off-ART participants and Arm C: Chloroquine then Placebo for on-ART participants, the baseline percent CD8 HLA-DR+/CD38+ (mean of pre-entry and entry percent CD8 HLA-DR+/CD38+) was subtracted from the mean of week 10 and week 12 percent CD8 HLA-DR+/CD38+. For Arm B: Placebo then Chloroquine for off-ART participants and Arm D: Placebo then Chloroquine for on-ART participants, the mean of week 10 and week 12 percent CD8 HLA-DR+/CD38+ was subtracted from the mean of week 22 and week 24 percent CD8 HLA-DR+/CD38+.|For Arms A and C: Pre-entry, entry, weeks 10 and 12. For Arms B and D: Weeks 10, 12, 22 and 24|Analysis used a modified as-treated approach, limited to participants with assay data at the required time points, and with no break in study treatment for >=14 days. Off-ART analysis excluded participants who started ART. On-ART analysis excluded participants who stopped ART or had virologic rebound (confirmed HIV-1 RNA>1000 copies/mL).||percent of CD8 expressing HLA-DR+/CD38+||Inter-Quartile Range|Median
847079|NCT00819390|Primary|Change in Percent CD8 HLA-DR+/CD38+ From Baseline to Week 12|The baseline percent CD8 HLA-DR+/CD38+ (mean of pre-entry and entry percent CD8 HLA-DR+/CD38+) was subtracted from the mean of week 10 and week 12 percent CD8 HLA-DR+/CD38+.|At pre-entry, entry, weeks 10 and 12|Analysis used a modified as-treated approach, limited to participants with assay data at baseline and weeks 10 or 12, and with no break in study treatment for >=14 days. Off-ART analysis excluded participants who started ART. On-ART analysis excluded participants who stopped ART or had virologic rebound (confirmed HIV-1 RNA>1000 copies/mL).||percent of CD8 expressing HLA-DR+/CD38+||Inter-Quartile Range|Median
847080|NCT00811928|Secondary|Number of Participants in Whom Mortality is Unlikely, Possibly, and Probably Related to Fungal Infection Occurred Within 100 Days From Randomization|"Exact Causes of Death and Their Relationship to IFI Episode Were As Follows:
Unlikely related: participant completed treatment and cause of death was due to primary disease or complication
Possibly related: IFI undergoing treatment without stabilization, or with failure to have a complete remission, where cause of death might have been due to IFI, including progression or relapse of primary disease
Probably related: autopsy or clinical signs suggested that progression of IFI was the probable cause of death"|From randomization date to Day 100|The full analysis set (FAS) included all of those randomized participants who received at least one dose of study drug, and had at least one post-treatment follow-up data of primary efficacy variable.||participants|||Number
847081|NCT00811928|Secondary|Number of Participants in Whom All-cause Mortality Occurred Within 100 Days From Randomization|Death from any cause.|Randomization date to Day 100|The full analysis set (FAS) included all of those randomized participants who received at least one dose of study drug, and had at least one post-treatment follow-up data of primary efficacy variable.||participants|||Number
847082|NCT00811928|Secondary|Number of Participants With Clinical Failure During Treatment|"Clinical failure was defined as follows:
Presence of a proven or probable IFI
Systemic antifungal treatment (IV) for 4 consecutive days or more than 10 days total
Discontinuation due to adverse event (AE) possibly or probably related to study drug
Lost-to-follow-up or discontinuation from the study for any reason with loss to follow-up during the Treatment Phase"|Up to 12 weeks (84 days)|The full analysis set (FAS) included all of those randomized participants who received at least one dose of study drug, and had at least one post-treatment follow-up data of primary efficacy variable.||participants|||Number
847083|NCT00811928|Secondary|Time From Randomization to Administration of First Systemic Antifungal Intravenous (IV) Therapy|The time measured in days from randomization to the administration of the first concomitant systemic anti-fungal therapy in the entire FAS population. Not all participants who accepted systemic anti-fungal therapy may have had a IFI clinical diagnosis. IFI diagnosis criteria for antifungal therapy administration may include: persistent fever, failure of appropriate broad-spectrum antibiotic treatment concomitant with lower respiratory tract infection symptoms, microbiological criteria with corresponding clinical signs and symptoms.|Up to 12 weeks (84 days)|The full analysis set (FAS) included all of those randomized participants who received at least one dose of study drug, and had at least one post-treatment follow-up data of primary efficacy variable.||Days|||Number
847117|NCT00799617|Secondary|Bone Trial - Bone Strength of Spine Peripheral Bone by Finite Element Analysis, N|Spine peripheral bone (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)|1 year (baseline to month 12)|||percentage of change||95% Confidence Interval|Mean
847084|NCT00811928|Secondary|Time From Randomization to the First Onset of Proven or Probable IFI|The time measured in days to the first occurrence of proven/probable IFI diagnosis in the entire FAS population from randomization to Day 100 of follow-up visit. Participants may not have accepted immediate antifungal treatment and later received antifungal treatment based upon further investigator review of the participant's IFI condition. IFI diagnosis criteria may include: persistent fever, failure of appropriate broad-spectrum antibiotic treatment concomitant with lower respiratory tract infection symptoms, positive blood/biopsy cultures with corresponding clinical signs and symptoms.|From randomization date to Day 100|The full analysis set (FAS) included all of those randomized participants who received at least one dose of study drug, and had at least one post-treatment follow-up data of primary efficacy variable.||Days|||Number
847085|NCT00811928|Secondary|Number of Participants With Proven or Probable Diagnosis of IFI Within 100 Days From Randomization|Number of participants who developed a proven or probable IFI from randomization date to Day 100 of follow-up visit. IFI diagnosis criteria may include: persistent fever, failure of appropriate broad-spectrum antibiotic treatment concomitant with lower respiratory tract infection symptoms, microbiological criteria with corresponding clinical signs and symptoms.|From randomization date to Day 100|The full analysis set (FAS) included all of those randomized participants who received at least one dose of study drug, and had at least one post-treatment follow-up data of primary efficacy variable.||participants|||Number
847086|NCT00811928|Primary|Number of Participants With Proven or Probable Diagnosis of Invasive Fungal Infection (IFI) During the Treatment Period|Number of participants developing a proven or probable IFI from randomization to the last dosage date (up to 12 weeks [84 days]) plus 7 days. IFI diagnosis criteria may include: persistent fever, failure of appropriate broad-spectrum antibiotic treatment concomitant with lower respiratory tract infection symptoms, microbiological criteria with corresponding clinical signs and symptoms.|Up to 12 Weeks (84 days) plus 7 days|The full analysis set (FAS) included all of those randomized participants who received at least one dose of study drug, and had at least one post-treatment follow-up data of primary efficacy variable.||participants|||Number
847087|NCT00808405|Secondary|Time to First Negative Herpes Simplex Virus (HSV) DNA PCR|To examine the time to first negative HSV DNA PCR among women who have a history of GUD and are HSV-2 seropositive and HIV-1 seronegative, and who are randomized to 400mg acyclovir or matching placebo|Days 1-5, 7, 9, 11, 13|Eligible women were 18-50 years of age, HIV-1 seronegative, HSV-2 seropositive and who presented to the study clinic with a new genital ulcer. Intention to treat analysis was used.||Days||Standard Error|Mean
847088|NCT00808405|Primary|Time to Healing of Genital Lesions|To examine time to healing of genital lesions among women who have a history of GUD and are HSV-2 seropositive and HIV-1 seronegative, and who are randomized to 400mg acyclovir or matching placebo|Days 1-5, 7, 9, 11, 13|Eligible women were 18-50 years of age, HIV-1 seronegative, HSV-2 seropositive and who presented to the study clinic with a new genital ulcer. Intention to treat analysis was used.||Days||Standard Error|Mean
847089|NCT00806351|Secondary|All-Cause Mortality|All-cause mortality during study therapy and at follow-up visits reported as unique deaths at EOIVT, end of oral treatment (EOT-oral), 2 Week Follow-Up and 6 Week Follow-Up|Baseline up to 6 weeks post treatment|Safety Population||participants|||Number
847090|NCT00806351|Secondary|Time to Death|Time to death defined as: date of death minus first treatment date plus 1.|Day 1 up to Day 98|Safety Population;subset of participants who died||days||Full Range|Median
847091|NCT00806351|Secondary|Time to First Negative Blood Culture for Candida Species|A participant had a negative blood culture, if having determined the day of the first negative blood culture, the subsequent blood culture was also negative, or if positive, the interval between the cultures was at least 2 days. For participants whose blood culture went from positive to negative, the time to negative blood culture defined as: date of first negative blood culture minus first treatment date plus 1.|Baseline up to Day 56|MITT Population; subset of participants who had a positive blood culture for Candida sp. on Day 1 of treatment. No participant in the Caspofungin treatment arm had a positive blood culture for Candida sp. on Day 1 of treatment.||days||Full Range|Median
847092|NCT00806351|Secondary|Number of Participants With New Infections|Participant counts of microbiologic response of new infection defined as clinical failure with emergence of new Candida sp not identified at baseline at the original site of infection or at a distant site of infection. Clinical failure defined as ≥3 doses study medication and no significant improvement of s/s or death due to Candida.|2 and 6 weeks post treatment|MITT Population||participants|||Number
847093|NCT00806351|Secondary|Number of Participants With Recurrence|Participant counts of microbiologic response of recurrence defined as any baseline Candida sp isolated following eradication, or culture data were not available for participants with a clinical response of failure after a previous response of success. Clinical failure defined as ≥3 doses study medication and no significant improvement of s/s or death due to Candida. Clinical success is resolution of s/s and no additional antifungal treatment needed.|2 and 6 weeks post treatment|MITT Population||participants|||Number
847094|NCT00806351|Secondary|Clinical Response at Day 10|Participant counts of clinical response categorized as success, failure, or indeterminate. Success: no s/s of Candida (cure) or significant but incomplete resolution of s/s of Candida; no additional systemic or oral antifungal treatment required (improvement). Failure: worsening of s/s of the Candida infection. Indeterminate: evaluation could not be made due to withdrawal from study prior to assessment of cure or failure. Participants who received fewer than 3 doses of study medication were assigned a clinical efficacy response of indeterminate.|Day 10|MITT Population; Number of participants analyzed (N): participants with evaluable data||participants|||Number
847095|NCT00806351|Secondary|Response Based on Clinical Cure and Microbiological Success at 6-Week Follow-Up Visit|Participant counts of clinical cure (no s/s of Candida) and microbiological success (eradication [f/u culture negative] or presumed eradication [f/u culture not available and a clinical response of cure]).|6 weeks post treatment|MITT Population; subset of participants with clinical cure or improvement and microbiological eradication or presumed eradication; Number of participants analyzed (N): participants with evaluable data a specified time point||participants|||Number
847118|NCT00799617|Secondary|Bone Trial - Bone Strength of Spine Trabecular Bone by Finite Element Analysis, N|Spine trabecular bone (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)|1 year (baseline to month 12)|||percentage of change||95% Confidence Interval|Mean
847096|NCT00806351|Secondary|Response Based on Clinical Cure and Microbiological Success at 2-Week Follow-Up Visit|Participant counts of clinical cure (no s/s of Candida) and microbiological success (eradication [f/u culture negative] or presumed eradication [f/u culture not available and a clinical response of cure]).|2 weeks post treatment|MITT Population; subset of participants with clinical cure or improvement and microbiological eradication or presumed eradication; Number of participants analyzed (N): participants with evaluable data a specified time point||participants|||Number
847097|NCT00806351|Secondary|Response Based on Clinical Cure and Microbiological Success at EOT|Participant counts of clinical cure (no s/s of Candida) and microbiological success (eradication [f/u culture negative] or presumed eradication [f/u culture not available and a clinical response of cure]).|Day 14 up to Day 56|MITT Population; subset of participants with clinical cure or improvement and microbiological eradication or presumed eradication. A global response of failure at EOT was carried forward programmatically to all subsequent visits.||participants|||Number
847098|NCT00806351|Secondary|Response Based on Clinical Cure and Microbiological Success at EOIVT|Participant counts of clinical cure (no s/s of Candida) and microbiological success (eradication [f/u culture negative] or presumed eradication [f/u culture not available and a clinical response of cure]).|Day 10 up to Day 42|MITT Population; subset of participants with clinical cure or improvement and microbiological eradication or presumed eradication. A global response of failure at EOIVT was carried forward programmatically to all subsequent visits.||participants|||Number
847099|NCT00806351|Secondary|Global Response at 6-Week Follow-Up Visit|Participant counts of global response of success, failure, or indeterminate. Success: clinical response of cure (no s/s of Candida) or improvement (significant, incomplete resolution of s/s) and microbiological response of eradication (f/u culture negative) or presumed eradication (f/u culture not available and clinical success). Failure: clinical response of failure (≥3 doses study medication and no significant improvement of s/s or death due to Candida) and/or unsuccessful microbiological response of persistent (positive culture any Candida sp), new infection or relapse at f/u. Indeterminate: clinical and/or microbiological response of indeterminate (evaluation could not be made due to withdrawal from study prior to assessment of cure or failure) and there was neither clinical response of failure nor unsuccessful microbiological response (persistence or new infection or relapse).|6 weeks post treatment|MITT Population; subset of participants who, according to the investigator, completed therapy and participants with global response of failure at EOIVT or EOT. A global response of failure at the 2-week and 6-week visits carried forward programmatically to all subsequent visits. Number of participants analyzed (N): participants with evaluable data.||participants|||Number
847100|NCT00806351|Secondary|Global Response at 2-Week Follow-Up Visit|Participant counts of global response of success, failure, or indeterminate. Success: clinical response of cure (no s/s of Candida) or improvement (significant, incomplete resolution of s/s) and microbiological response of eradication (f/u culture negative) or presumed eradication (f/u culture not available and clinical success). Failure: clinical response of failure (≥3 doses study medication and no significant improvement of s/s or death due to Candida) and/or unsuccessful microbiological response of persistent (positive culture any Candida sp), new infection or relapse at f/u. Indeterminate: clinical and/or microbiological response of indeterminate (evaluation could not be made due to withdrawal from study prior to assessment of cure or failure) and there was neither clinical response of failure nor unsuccessful microbiological response (persistence or new infection or relapse).|2 weeks post treatment|MITT Population; subset of participants who, according to the investigator, completed therapy and participants with global response of failure at EOIVT or EOT. A global response of failure at the 2-week and 6-week visits carried forward programmatically to all subsequent visits. Number of participants analyzed (N): participants with evaluable data.||participants|||Number
847101|NCT00806351|Secondary|Global Response at End of Treatment (EOT)|Participant counts of global response of success, failure, or indeterminate. Success: clinical response of cure (no s/s of Candida) or improvement (significant, incomplete resolution of s/s) and microbiological response of eradication (f/u culture negative) or presumed eradication (f/u culture not available and clinical success). Failure: clinical response of failure (≥3 doses study medication and no significant improvement of s/s or death due to Candida) and/or unsuccessful microbiological response of persistent (positive culture any Candida sp), new infection or relapse at f/u. Indeterminate: clinical and/or microbiological response of indeterminate (evaluation could not be made due to withdrawal from study prior to assessment of cure or failure) and there was neither clinical response of failure nor unsuccessful microbiological response (persistence or new infection or relapse).|Day 14 up to Day 56|MITT Population; A global response of failure at EOT was carried forward programmatically to all subsequent visits.||participants|||Number
847102|NCT00806351|Primary|Global Response at End of Intravenous Treatment (EOIVT)|Participant counts of global response of success, failure, or indeterminate. Success: clinical response of cure (no signs, symptoms [s/s] of Candida) or improvement (significant, incomplete resolution of s/s) and microbiological response of eradication (follow-up [f/u] culture negative) or presumed eradication (f/u culture not available and clinical success). Failure: clinical response of failure (greater than or equal to [≥3] doses study medication and no significant improvement of s/s or death due to Candida) and/or unsuccessful microbiological response of persistent(positive culture any Candida species [sp]), new infection or relapse at f/u. Indeterminate: clinical and/or microbiological response of indeterminate (evaluation could not be made due to withdrawal from study prior to assessment of cure or failure) and there was neither clinical response of failure nor unsuccessful microbiological response (persistence or new infection or relapse).|Day 10 up to Day 42|Modified Intent to Treat (MITT) Population: participants who received at least 1 dose of study medication and had positive culture for Candida sp isolated from cultures obtained from a normally sterile site within 96 hours prior to treatment initiation. A global response of failure at EOIVT was carried forward programmatically to subsequent visits.||participants|||Number
847103|NCT00804843|Primary|Total Cholesterol and Free Cholesterol Measured by Enzymatic Chromogenic Assay|Cholesterol ester was to be calculated by the following formula: Cholesterol Ester = Total Cholesterol – Free Cholesterol.|At time of carotid endarterectomy (after 4 to 12 weeks of dosing)|Only participants who completed the study, had evaluable plaque samples and were at least 80% compliant with dosing schedule were to be included in the analysis. This was not performed due to technical concerns. Instead, the cholesterol content determination, if performed, will use mass spectrometry approach and would be an exploratory objective.|||||
847104|NCT00804843|Primary|Plaque Instability Protein Composite Score|Each excised plaque was analyzed using an assay of 20 proteins that reflect plaque composition and inflammation. Each protein was assigned scaled signs, with a lower (negative) sign associated with plaque stability and a higher (positive) sign associated with plaque inflammation/instability. The Composite Score was the average amounts of all the 20 proteins with their associated signs. A higher Composite Score is associated with more plaque instability.|At time of carotid endarterectomy (after 4 to 12 weeks of dosing)|Only participants who completed the study, had evaluable plaque samples and were at least 80% compliant with dosing schedule were included in the analysis.||Score||Standard Deviation|Mean
847105|NCT00804843|Primary|Composite Score of Plaque Inflammation/Stability Gene Expression as Assayed by Ribonucleic Acid (RNA) Taqman Analysis|"Excised carotid plaques were evaluated for the gene expression of 60 biomarkers associated with inflammation (Hot biomarkers) & 25 biomarkers associated with stability (Cold biomarkers). Each biomarker was assayed using a quantitative polymerase chain reaction method and results were reported as a Cycle Threshold, (Ct). A Composite Score was calculated by averaging the Ct for each of the 25 cold genes, and subtracting the average Ct for the 60 hot genes. A higher composite score was associated with greater inflammation and a lower score was associated with stability (non-inflamed)."|At time of carotid endarterectomy (after 4 to 12 weeks of dosing)|Only participants who completed the study, had evaluable plaque samples and were at least 80% compliant with dosing schedule were included in the analysis.||Cycle threshold (Ct)||Standard Deviation|Mean
847106|NCT00804609|Primary|Maximum Plasma Concentration (Cmax) of Extended Release Epidural Morphine (EREM)|The primary end point was to evaluate the pharmacokinetic profiles of EREM after either no epidural lidocaine or after an epidural lidocaine top-up for cesarean delivery.|a plasma sample at 0, 5, 10, 15, and 30 minutes, and 1, 4, 8, 12, 24, 36, 48, and 72 hours post-dose|||ng/mL||Standard Deviation|Mean
847107|NCT00799617|Secondary|Anemia Trial - Effect of Testosterone on Hemoglobin Levels - Unexplained Anemia - Hemoglobin (Continuous)|"Proportion of men age 65 years or older with unexplained anemia who increased their hemoglobin level by 1.0 gm/dL from baseline.
Values are means (SDs) for continuous outcomes."|1 year (baseline to month 12)|||proportion of participants||Standard Deviation|Mean
847108|NCT00799617|Secondary|Cognitive Function Trial - Executive Function - Trail Making Test B - A|"Baseline score and change in score in Executive Function as Measured by Trail-Making Test (TMT) B - A, at baseline, Month 6 and Month 12.
Change in performance on the Trail Making Test was analyzed using linear random effects models adjusting for baseline performance, balancing factors, education, and test version.
Participants are required to connect a set of numbers (Part A) or alternating letters and numbers (Part B) in sequential order. The score for each part is the total time (in seconds) to complete both parts. The outcome analyzed will be the total time for Trails B minus the total time for Trails A to provide a measure of working memory, adjusted for attention and processing speed. Higher scores reflect lower executive function."|1 year (baseline to month 6 to month 12)|||Score on the Trail Making Test scale||95% Confidence Interval|Mean
847109|NCT00799617|Secondary|Cognitive Function Trial - Spatial Ability Card Rotation Test (CRT)|"Baseline score and change in score in the Spatial Ability Using the Card Rotation Test at baseline, Month 6 and Month 12.
Change in performance on the Card Rotations Test will be analyzed using linear random effects models adjusting for baseline performance, balancing factors, education, and test version. The test consists of a series of 10 primary figures, each of which has 8 corresponding secondary figures. Subjects are asked to determine which of the secondary figures is the same as the corresponding primary figure, and the score is taken as the number of figures answered correctly minus the number of figures answered incorrectly.
The maximum score is 80 for subjects who answer all items correctly."|1 year (baseline to month 6 to month 12)|||Score on the CRT test scale||95% Confidence Interval|Mean
847110|NCT00799617|Secondary|Cognitive Function Trial - Visual Memory - Benton Visual Retention Test (BVRT)|"Baseline score and mean change in score in the Visual Memory Using the Benton Visual Retention Test (BVRT) from baseline, Month 6 and Month 12.
The BVRT measures short term visual memory and visuo-constructional abilities and was administered and scored according to standard procedures. Each of 10 designs was presented one at a time for 10 seconds, and immediately after the design was withdrawn, the participant was instructed to draw it from memory on a blank sheet of paper. The score was the total number of figures with errors and ranged from 0 to 26. Scores were inverted to 0 to -26 so that higher scores would reflect better performance.
Change in BVRT scores from baseline are treated as continuous and compared between AAMI Androgel and placebo subjects using linear random effects models adjusting for balancing factors as described in the primary analysis."|1 year (baseline to month 6 and month 12)|||Score on the BVRT test scale||95% Confidence Interval|Mean
847111|NCT00799617|Secondary|Bone Trial - Area Bone Mineral Density (BMD) of Femoral Neck by Dual-energy X-ray Absorptiometry (DXA)|Femoral neck as measured by DXA, g/cm2 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)|1 year (baseline to month 12)|||percentage of change||95% Confidence Interval|Mean
847112|NCT00799617|Secondary|Bone Trial - Area Bone Mineral Density (BMD) of Total Hip by Dual-energy X-ray Absorptiometry (DXA)|Total hip as measured by DXA, g/cm2 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)|1 year (baseline to month 12)|||percentage of change||95% Confidence Interval|Mean
847113|NCT00799617|Secondary|Bone Trial - Area Bone Mineral Density (BMD) of Lumbar Spine by Dual-energy X-ray Absorptiometry (DXA)|Lumbar spine as measured by DXA, g/cm2 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)|1 year (baseline to month 12)|||percentage of change||95% Confidence Interval|Mean
847114|NCT00799617|Secondary|Bone Trial - Bone Strength of Hip Peripheral Bone by Finite Element Analysis, N|Hip peripheral bone (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)|1 year (baseline to month 12)|||percentage of change||95% Confidence Interval|Mean
847115|NCT00799617|Secondary|Bone Trial - Bone Strength of Hip Trabecular Bone by Finite Element Analysis, N|Hip trabecular bone (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)|1 year (baseline to month 12)|||percentage of change||95% Confidence Interval|Mean
847116|NCT00799617|Secondary|Bone Trial - Bone Strength of Hip Whole Bone by Finite Element Analysis, N|Hip whole bone (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)|1 year (baseline to month 12)|||percentage of change||95% Confidence Interval|Mean
847121|NCT00799617|Secondary|Bone Trial - Volumetric Bone Mineral Density (BMD) of Hip Peripheral Bone by Quantitative Computed Tomography (QCT)|Hip peripheral bone as measured by QCT, mg/cm3 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)|1 year (baseline to month 12)|||percentage of change||95% Confidence Interval|Mean
847122|NCT00799617|Secondary|Bone Trial - Volumetric Bone Mineral Density (BMD) of Hip Trabecular Bone by Quantitative Computed Tomography (QCT)|Hip trabecular bone as measured by QCT, mg/cm3 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)|1 year (baseline to month 12)|||percentage of change||95% Confidence Interval|Mean
847123|NCT00799617|Secondary|Bone Trial - Volumetric Bone Mineral Density (BMD) of Spine Whole Bone by Quantitative Computed Tomography (QCT)|Spine whole bone as measured by QCT, mg/cm3 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)|1 year (baseline to month 12)|||percentage of change||95% Confidence Interval|Mean
847124|NCT00799617|Secondary|Bone Trial - Volumetric Bone Mineral Density (BMD) of Spine Peripheral Bone by Quantitative Computed Tomography (QCT)|Spine peripheral bone as measured by QCT, mg/cm3 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)|1 year (baseline to month 12)|||percentage of change||95% Confidence Interval|Mean
847125|NCT00799617|Secondary|Cardiovascular Trial - Coronary Artery Calcium Score, Agatston Units Change From Baseline|Coronary artery calcium score in Agatston units (range of 0 to >400 Agatston units), with higher values indicating more severe atherosclerosis).|1 year (change from baseline to month 12)|All participants with measurements of both baseline and 12-month assessments were included in the analysis.||Agatston units||95% Confidence Interval|Least Squares Mean
847126|NCT00799617|Secondary|Cardiovascular Trial - Total Plaque Volume Change From Baseline|Total plaque volume,mm3 measured by coronary computed tomographic angiography|1 year (change from baseline to month 12)|||mm^3||95% Confidence Interval|Mean
847127|NCT00799617|Secondary|Vitality Trial - Patient Health Questionnaire 9 (PHQ-9) Change in Overall Score|"Baseline score and change in score in the Patient Health Questionnaire 9 (PHQ-9) from baseline to Month 12.
Scores on the Patient Health Questionnaire 9 (PHQ-9) depression scale range from 0 to 27, with higher scores indicating greater intensity of depressive symptoms."|1 year (change from baseline to month 3, 6, 9 and 12)|||Score on the PHQ-9 test scale||Standard Deviation|Mean
847128|NCT00799617|Secondary|Vitality Trial - Change in the Total Negative Affect Score of the Positive and Negative Affect Scales (PANAS) From Baseline to Month 12|"Baseline score and change in the total negative affect score of the Positive and Negative Affect Scales (PANAS) from baseline to Month 12.
Scores for positive affect and for negative affect on the Positive and Negative Affect Schedule (PANAS) scales range from 5 to 50, with higher scores indicating a greater intensity of the affect."|1 year (change from baseline to month 3, 6, 9 and 12)|||Score on the PANAS test scale||Standard Deviation|Mean
847129|NCT00799617|Secondary|Vitality Trial - Change in the Positive Affect Score of the Positive and Negative Affect Scales (PANAS) From Baseline to Month 12.|"Baseline score and change in the total positive affect score of the Positive and Negative Affect Scales (PANAS) from baseline to Month 12.
Scores for positive affect and for negative affect on the Positive and Negative Affect Schedule (PANAS) scales range from 5 to 50, with higher scores indicating a greater intensity of the affect."|1 year (change from baseline to month 3, 6, 9 and 12)|||Score on the PANAS test scale||Standard Deviation|Mean
847130|NCT00799617|Secondary|Vitality Trial - SF-36 Score|Baseline score and change in the SF-36 Vitality Score from baseline to Month 12 Scores on the vitality scale of the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) range from 0 to 100, with higher scores indicating less fatigue.|1 year (change from baseline to month 3, 6, 9 and 12)|||Score on the SF-36 vitality scale||Standard Deviation|Mean
847131|NCT00799617|Secondary|Vitality Trial - FACIT Fatigue Overall Score|Baseline score and change in the FACIT– Fatigue score from baseline to Month 12. Scores on the Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue scale range from 0 to 52, with higher scores indicating less fatigue.|1 year (change from baseline to month 3, 6, 9 and 12)|||Score on the FACIT- Fatigue test scale||Standard Deviation|Mean
847132|NCT00799617|Secondary|Physical Function Trial - PF 10 Overall Score|"Baseline score and the change in score on the physical-function scale (PF-10) of the Medical Outcomes Study 36-Item Short Form Health Survey range from 0 to 100, with higher scores indicating better function.
Scores were measured as the change from baseline to Month 12."|1 year (change from baseline to month 3, 6, 9 and 12)|||Score on the PF-10 test scale||Standard Deviation|Mean
847133|NCT00799617|Secondary|Physical Function Trial - The Physical Function Domain (PF-10) of the SF-36 - no./Total no. (%)|The number of participants whose score on the physical-function domain (PF-10; range, 0 to 100, with higher scores indicating better function) of the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) increased by at least 8 points from baseline to Month 12.|1 year (change from baseline to month 3, 6, 9 and 12)|The number analyzed differs from the overall number due to participant withdrawal or test results that were incomplete.||Participants|||Count of Participants
847134|NCT00799617|Secondary|Physical Function Trial - 6 Minute Walk Test - Total Walking Distance in Meters|Baseline score and the change in distance walked in the 6-Minute Walking Test in meters from baseline to Month 12|1 year (change from baseline to month 3, 6, 9 and 12)|||meters||Standard Deviation|Mean
847135|NCT00799617|Secondary|Sexual Function Trial - Erectile Function|"Baseline score and the change in score on the International Index of Erectile Function (IIEF) from baseline to Month 12.
Scores on the IIEF range from 0-30, with higher scores indicating better function."|1 year (change from baseline to month 3, 6, 9 and 12)|||Score on the IIEF test scale||Standard Deviation|Mean
847136|NCT00799617|Secondary|Sexual Function Trial - Sexual Desire Domain|"Baseline score and the changes in the score of the sexual-desire domain of the Derogatis Interview for Sexual Functioning in Men-II (DISF-M-II), from baseline to Month 12.
Scores on the (DISF-M-II) range from 0 to 33, with higher scores indicating greater sexual desire."|1 year (change from baseline to month 3, 6, 9 and 12)|||Score on the DISF-M-II scale||Standard Deviation|Mean
847152|NCT00783263|Secondary|Number of Participants Who Reached the LDL-C Level of <70 mg/dl|Participants across all strata who reached the LDL-C Level of <70 mg/dl after the addition of ezetimibe 10 mg to rosuvastatin (5 or 10 mg) daily for 6 weeks compared with doubling the baseline dose of rosuvastatin (10 or 20 mg) daily for 6 weeks.|6 weeks of treatment|||participants|||Number
847137|NCT00799617|Primary|Anemia Trial - Effect of Testosterone on Hemoglobin Levels - Unexplained Anemia|"Proportion of men age 65 years or older with unexplained anemia who increased their hemoglobin level by 1.0 g/dL from baseline.
Values are No. (%) for dichotomous outcomes. Dichotomous hemoglobin response is an increase of 1 g/dL or more from baseline."|1 year (change in hemoglobin g/dL from baseline to month 3, 6, 9 and 12)|Unexplained anemia is anemia that is not due to the following causes: iron and vitamin B12 deficiency, chronic inflammation and disease, chronic renal insufficiency, myelodysplastic syndromes.||Participants|||Count of Participants
847138|NCT00799617|Primary|Cognitive Function Trial - Delayed Paragraph Recall Wechsler Memory Scale Revised Logical Memory II (WMS-R LMII)|"Baseline score and change in score of the Wechsler Memory Scale Revised Logical Memory II (WMS-R LMII) test of Delayed Paragraph Recall, at baseline, Month 6 and Month 12.
The WMS-R LM II involves a delayed paragraph recall activity scored in two components, each ranging from 0-25. The final score is the sum of each component, therefore falling in the range 0-50. WMS-R LM II scores were treated as continuous with change compared between treatment arms using linear random effects models adjusting for several factors: site, indicator variables of participation in each primary efficacy trial, baseline testosterone concentration (<200), age (≤ 75), use of anti-depressants, use of PDE-inhibitors, baseline WMSR, categorical education, and version of the WMSR."|1 year (change from baseline to month 6 and month 12)|Men, age 65 years or older with low testosterone and Age-Associated Memory Impairment (AAMI)||percentage of change in test score||95% Confidence Interval|Mean
847139|NCT00799617|Primary|Bone Trial - Volumetric Bone Mineral Density (BMD) of Spine Trabecular Bone by Quantitative Computed Tomography (QCT) in Older Men With Low Testosterone|Volumetric Bone Mineral Density (BMD) of spine trabecular bone as measured by QCT, mg/cm3, the calculated change in measurement from baseline to Month 12|1 year (QCT measurement of BMD change between baseline and month 12)|||mg/cm^3||95% Confidence Interval|Mean
847140|NCT00799617|Primary|Cardiovascular Trial - Assess Impact of Testosterone Treatment in Older Men on Noncalcified Plaque Volume|Non-calcified coronary artery plaque volume, mm3, as determined by coronary computed tomographic angiography (CTA), mean difference in change from baseline to month 12|1 year (change in plaque volume measurement from baseline to month 12)|Men aged 65 years or > with an average of 2 serum testosterone levels lower than 275 ng/L and enrolled in the CV Trial of the Testosterone Trials between June 2010 and June 2014.||mm^3||95% Confidence Interval|Mean
847141|NCT00799617|Primary|Vitality Trial - Increase in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Score Greater Than or Equal to 4 - no./Total no. (%)|"The number of participants whose score on the FACIT–Fatigue scale increased by at least 4 points.
Scores on the FACIT- Fatigue scale range from 0 to 52, with higher scores indicating less fatigue."|1 year (Number of participants who increased FACIT-Fatigue score > or = to 4, change from baseline to month 3, 6, 9 and 12)|The number analyzed differs from the overall number due to participant withdrawal or test results that were incomplete.||Participants|||Count of Participants
847142|NCT00799617|Primary|Physical Function Trial - The 6-Minute Walk Test - no./Total no. (%)|The number and percentage of men who increased the distance walked in the 6-Minute Walk Test by at least 50 meters.|1 year (Number of participants who increased walk distance > or = 50 meters, change from baseline to month 3, 6, 9 and 12)|The number analyzed differs from the overall number due to participant withdrawal or test results that were incomplete.||Participants|||Count of Participants
847143|NCT00799617|Primary|Sexual Function Trial - Change in Psychosexual Daily Questionnaire Question 4 (PDQ-Q4) From Baseline to Month 12|"Baseline score and change in responses to Question 4 of the Psychosexual Daily Questionnaire (PDQ-Q4) from baseline to Month 12.
Question 4 asks 12 questions about sexual activity. Scores on the PDQ-Q4 range from 0 to 12, with higher scores indicating more activity.
The change is measured form the baseline value to Month 12."|1 year (change from baseline to month 3, 6, 9 and 12)|||units on the PDQ-Q4 scale||Standard Deviation|Mean
847144|NCT00793780|Secondary|Change in Questionnaire on Craving for Sweet or Rich Foods Score|The Questionnaire on Craving for Sweet or Rich Foods (QCSRF) is a 2-factor, 9-item scale assessing the presence of cravings for rich and sweet foods and has been found to have good psychometric properties. The total score is the total of 2 sub scales. Total range is from 9 to 63, with a higher score indicative of a higher craving and reinforcement from sweet and/or rich foods.|baseline and week 8|||units on a scale||Standard Deviation|Mean
847145|NCT00793780|Secondary|LDL Cholesterol|Determined by standard enzymatic procedures|baseline and week 8|||mg/dL||Standard Deviation|Mean
847146|NCT00793780|Secondary|Insulin Levels|Determined with a double-antibody radioimmunoassay|baseline and week 8|||microIU/mL||Standard Deviation|Mean
847147|NCT00793780|Secondary|PANSS- Positive and Negative Symptom Scale|The PANSS or the Positive and Negative Syndrome Scale is a medical scale used for measuring symptom severity of patients with schizophrenia. The patient is rated from 1 to 7 on 30 different symptoms based on the interview as well as reports of family members or primary care hospital workers. Of the 30 items included in the PANSS, 7 constitute a Positive Scale, 7 a Negative Scale, and the remaining 16 a General Psychopathology Scale.The scores for these scales are arrived at by summation of ratings across component items. Total score ranges from a minimum of 30 to a maximum of 210. A higher score indicates more severe symptoms.|8 weeks|||units on a scale||Standard Deviation|Mean
847148|NCT00793780|Secondary|Fasting Serum Glucose Lab Values||baseline and 8 weeks|||mg/dL||Standard Deviation|Mean
847149|NCT00793780|Primary|Change in Body Weight From Baseline|Weight was measured with shoes off to the nearest 0.1 kg.|8 weeks|||kg||95% Confidence Interval|Mean
847150|NCT00783263|Secondary|Percent Change From Baseline in Other Lipid, Lipoprotein, Apolipoprotein and High-sensitivity C-reactive Protein (Hs-CRP)Levels|Participants who were analyzed to assess the Total Cholesterol (TC), Triglycerides, High-Density Lipoprotein Cholesterol, Non High-Density Lipoprotein Cholesterol, LDL Cholesterol/HDL Cholesterol, Total Cholesterol/HDL Cholesterol, Non-HDL Cholesterol/HDL Cholesterol, Apolipoprotein B (Apo B), Apolipoprotein A-I (Apo A-I), Apolipoprotein B/Apo A-I, high-sensitivity C-reactive protein (hs-CRP)levels after 6 weeks of treatment.|Baseline to 6 weeks|||percentage change||Standard Deviation|Mean
847151|NCT00783263|Secondary|Number of Participants in Each Stratum Who Reached the LDL-C Level of <70 mg/dl|Participants in stratum I and in stratum II who reached the LDL-C Level of <70 mg/dl after the addition of ezetimibe to rosuvastatin (5 or 10 mg)daily for 6 weeks compared with doubling the baseline dose of rosuvastatin (10 or 20 mg).|6 weeks of treatment|||participants|||Number
847153|NCT00783263|Secondary|Number of Participants in Each Stratum Who Reached Their Target LDL-C Level|Participants in stratum I were analyzed to evaluate the LDL-C lowering efficacy with the additional of ezetimibe 10 mg to rosuvastatin 5 mg daily for 6 weeks compared with doubling the baseline dose to rosuvastatin 10 mg daily for 6 weeks. Participants in stratum II were analyzed to evaluate the LDL-C lowering efficacy with the additional of ezetimibe 10 mg to rosuvastatin 10 mg daily for 6 weeks compared with doubling the baseline dose to rosuvastatin 20 mg daily for 6 weeks.|6 weeks of treatment|||participants|||Number
847154|NCT00783263|Secondary|Number of Participants Who Reached Their Target LDL-C Level|Participants were analyzed to evaluate the LDL-C (<100 mg/dL for moderately high risk patients and high risk patients without AVD and <70 mg/dL for high risk patients with AVD) lowering efficacy with the addition of ezetimibe 10 mg to (5 or 10 mg) compared with doubling the baseline rosuvastatin (10 or 20 mg), daily for 6 weeks of treatment.|6 weeks of treatment|||participants|||Number
847155|NCT00783263|Secondary|Percent Change From Baseline in LDL-Cholesterol (mg/dL) After 6 Weeks of Treatment in Each Stratum|The percent change from baseline in LDL-C (mg/dL) after 6 weeks of treatment by stratum I and stratum II in participants who were administered with ezetimibe 10 mg to rosuvastatin (5 or 10 mg) in comparison with the doubling of the baseline dose of rosuvastatin (10 or 20 mg) daily for 6 weeks.|Baseline to 6 weeks|||percentage change||Standard Deviation|Mean
847156|NCT00783263|Primary|Percent Change From Baseline in LDL-Cholesterol (mg/dL) After 6 Weeks of Treatment|The percent change from baseline in LDL-C (mg/dL) after 6 weeks of treatment in participants who were administered ezetimibe 10 mg to rosuvastatin (5 or 10 mg) in comparison with doubling the baseline dose of rosuvastatin (10 or 20 mg) daily for 6 weeks.|Baseline to 6 weeks|||percent change||Standard Deviation|Mean
847157|NCT00771667|Secondary|Number of Participants With Clinical Response at Week 22 (Among Responders From Week 6)|As measured by the CDAI. Clinical response was defined as a reduction from baseline of ≥ 100 points. Participants with a baseline CDAI of ≥ 220 to ≤ 248 were considered to be in clinical response if a CDAI score of < 150 was attained.|Baseline to Week 22|All participants who were randomized, regardless of whether they received study agent.||Participants|||Number
847158|NCT00771667|Secondary|Number of Participants With Clinical Remission at Week 22 (Among Responders From Week 6)|As measured by a CDAI score of < 150 points.|Baseline to Week 22|All participants who were randomized, regardless of whether they received study agent.||Participants|||Number
847159|NCT00771667|Secondary|Number of Participants With Clinical Remission at Week 8|As measured by a CDAI score of < 150 points.|Baseline to Week 8|All participants who were randomized, regardless of whether they received study agent.||Participants|||Number
847160|NCT00771667|Secondary|Number of Participants With Clinical Response at Week 8|As measured by the CDAI. Clinical response was defined as a reduction from baseline of ≥ 100 points. Participants with a baseline CDAI of ≥ 220 to ≤ 248 were considered to be in clinical response if a CDAI score of < 150 was attained.|Baseline to Week 8|All participants who were randomized, regardless of whether they received study agent.||Participants|||Number
847161|NCT00771667|Secondary|Number of Participants With Clinical Response at Week 4|As measured by the CDAI. Clinical response was defined as a reduction from baseline of ≥ 100 points. Participants with a baseline CDAI of ≥ 220 to ≤ 248 were considered to be in clinical response if a CDAI score of < 150 was attained.|Baseline to Week 4|All participants who were randomized, regardless of whether they received study agent.||Participants|||Number
847162|NCT00771667|Secondary|Number of Participants With Clinical Remission at Week 6|As measured by a CDAI score of < 150 points.|Baseline to Week 6|All participants who were randomized, regardless of whether they received study agent.||Participants|||Number
847163|NCT00771667|Primary|Number of Participants With Clinical Response at Week 6|As measured by the Crohn's Disease Activity Index (CDAI). CDAI scores range from 0 points (minimal disease activity) to over 600 points (severe disease activity). Clinical response was defined as a reduction from baseline of ≥ 100 points. Participants with a baseline CDAI of ≥ 220 to ≤ 248 were considered to be in clinical response if a CDAI score of < 150 was attained.|Baseline to Week 6|All participants who were randomized, regardless of whether they received study agent.||Participants|||Number
847164|NCT00770341|Secondary|Study Investigators' Assessment of Clinical Response at TOC|Clinical Success = Study investigator's Clinical Response confirmed by the EAC as either cured or improved at EOT.|7-14 days for SSTI, 14-42 days for septicemia and RIE|MITT-MRSA; One participant with possible MRSA RIE was enrolled into this study. This participant was excluded from the efficacy population.||Participants|||Number
847165|NCT00770341|Secondary|Study Investigators' Assessment of Clinical Response at EOT|Clinical Success = Study investigator's Clinical Response confirmed by the EAC as either cured or improved at EOT.|7-14 days for SSTI, 14-42 days for septicemia and RIE|MITT-MRSA; One participant with possible MRSA RIE was enrolled into this study. This participant was excluded from the efficacy population.||Participants|||Number
847166|NCT00770341|Secondary|EAC Assessment of Number of Participants With Microbiological Response at End of Treatment (EOT).|"Response = eradicated or presumed eradicated.
Eradicated was defined as absence of the admission pathogen in a culture obtained in the absence of potentially effective antibiotics for the pathogen.
Presumed eradicated was defined as no material for culture was available due to improvement of infection, but the admission pathogen was presumed to be eradicated because the participant was deemed Cured or Improved by the investigator and the participant did not receive potentially effective antibiotics for the pathogen."|7-14 days for SSTI, 14-42 days for septicemia and RIE|MITT-MRSA; one participant with possible MRSA RIE was enrolled into this study. This participant was excluded from the efficacy population.||Participants|||Number
847167|NCT00770341|Primary|Efficacy Adjudication Committee (EAC) Assessment of Number of Participants With Microbiological Response at TOC|"Response = eradicated or presumed eradicated.
Eradicated was defined as absence of the admission pathogen in a culture obtained in the absence of potentially effective antibiotics for the pathogen.
Presumed eradicated was defined as no material for culture was available due to improvement of infection, but the admission pathogen was presumed to be eradicated because the participant was deemed Cured or Improved by the investigator and the participant did not receive potentially effective antibiotics for the pathogen."|7-14 days for SSTI, 14-42 days for septicemia and RIE|MITT-MRSA; one participant with possible MRSA RIE was enrolled into this study. This participant was excluded from the efficacy population.||Participants|||Number
847168|NCT00770341|Secondary|EAC Assessment of Number of Participants With Clinical Success at End of Treatment (EOT).|Clinical Success = Study investigator's Clinical Response confirmed by the EAC as either cured or improved at EOT.|7-14 days for SSTI, 14-42 days for septicemia and RIE|MITT-MRSA; one participant with possible MRSA RIE was enrolled into this study. This participant was excluded from the efficacy population.||Participants|||Number
847169|NCT00770341|Primary|Efficacy Adjudication Committee (EAC) Assessment of Number of Participants With Clinical Success at Test of Cure (TOC)|"Clinical Success = Study investigator's Clinical Response confirmed by the EAC as either cured or improved at end of treatment (EOT).
MITT-MRSA (modified intent-to-treat - methicillin-resistant Staphylococcus aureus) was a subset of allocated participants with participants who were excluded for any of the following reasons: no MRSA isolated + any 1 of the following: failure to receive ≥1 dose of study drug, lack of all post-allocation primary and secondary endpoint data after ≥1 dose of study drug, no gram (+) coccus isolated at baseline."|7-14 days for SSTI, 14-42 days for septicemia and right-sided infective endocarditis (RIE)|MITT-MRSA; One participant with possible MRSA RIE was enrolled. This participant was excluded from the efficacy population.||Participants|||Number
847170|NCT00761280|Secondary|Median Time to Progression (Days) by Independent Review for the Intent-to-treat Population (Descriptive Analysis, Only)|Time to progression was calculated from the date of randomization to the date of the first documented tumor progression. Participants who did not progress or died were censored at the last tumor assessment date or the date of start of a new anti-tumor treatment or death.|Up to 24 months|The Intent-to-treat population includes all participants randomized.||days||95% Confidence Interval|Median
847171|NCT00761280|Secondary|Disease Progression Rate at 10, 12, 14, 16, 18, 21, and 24 Months by Independent Review in the Intent-to-treat Population - Percentage of Participants (Descriptive Analysis, Only)|"Tumor response was classified based on the (neuro-)radiologist’s evaluation:
Complete Response (CR): Disappearance of all enhancing tumor on consecutive MRI scans at least 1 month apart, off steroids, neurologically stable or improved.
Partial Response (PR): ≥50% reduction in size of enhancing tumor on consecutive MRI scans at least 1 month apart, steroids stable or reduced, neurologically stable or improved.
Progressive Disease (PD): ≥25% increase in size of enhancing tumor or any new tumor on MRI scans, steroids stable or increased, neurologically worse.
Stable Disease (SD): all other situations.
Based on clinical and imaging data, an independent neuro-oncologist made the final assessment of Progressed versus Not Progressed. Participants who had MRI assessment results missing or unknown were UNK or missing, and were treated as Progressed for the purposes of the calculation."|10, 12, 14, 16, 18, 21 and 24 months|The Intent-to-treat population includes all participants randomized.||percentage of participants||95% Confidence Interval|Number
847172|NCT00761280|Secondary|Disease Progression at 10, 12, 14, 16, 18, 21, and 24 Months by Independent Review in the Intent-to-treat Population - Number of Participants|"Tumor response was classified based on the (neuro-)radiologist’s evaluation:
Complete Response (CR): Disappearance of all enhancing tumor on consecutive MRI scans at least 1 month apart, off steroids, neurologically stable or improved.
Partial Response (PR): ≥50% reduction in size of enhancing tumor on consecutive MRI scans at least 1 month apart, steroids stable or reduced, neurologically stable or improved.
Progressive Disease (PD): ≥25% increase in size of enhancing tumor or any new tumor on MRI scans, steroids stable or increased, neurologically worse.
Stable Disease (SD): all other situations.
Based on clinical and imaging data, an independent neuro-oncologist made the final assessment of Progressed versus Not Progressed. Participants who had MRI assessment results missing or unknown were UNK or missing, and were treated as Progressed for the purposes of the calculation."|10, 12, 14, 16, 18, 21, and 24 months|The Intent-to-treat population includes all participants randomized.||participants|||Number
847173|NCT00761280|Secondary|Median Duration of Response (Days) by Independent Review (Descriptive Analysis, Only)|"Duration of response was defined as the time from the first documentation of confirmed response (Complete Response, CR, or Partial Response, PR) to the first signs of Progressive Disease (PD), as assessed by the study neuro-oncologist. Median Duration of Response was calculated by Kaplan-Meier estimate.
Censoring rules were:
at the date of randomization -- participants without baseline assessments, or for those with no post-baseline timor assessments who were discontinued for other than progressive disease or death.
at the date of last tumor assessment -- discontinuation other than PD or death, or if a new treatment was started prior to disease progression
at the date of death or last tumor assessment -- death or PD after one missed tumor assessment
at the date of last tumor assessment -- death or PD after more than one missed tumor assessment
at the date of last tumor assessment -- participants on ongoing treatment at data cut-off"|Up to 24 months|The Intent-to-treat population includes all participants randomized.||days||95% Confidence Interval|Median
847174|NCT00761280|Primary|Survival at 24 Months in the Intent-to-treat Population - Number of Participants|"Survival status was assessed at 24 months from randomization. Participants with unknown or missing status were considered treatment failures, i.e., assumed to be dead. The category Lost to / insufficient follow-up includes participants who were alive at last data collection point but did not yet have enough follow-up time to reach the 24 month time point."|24 months|The Intent-to-treat population includes all participants randomized. Early study discontinuation with site closures led to a high proportion of participants being censored or lost to follow-up in the initial analysis. Additional survival data were collected in a post-hoc fashion under a protocol amendment. These data are presented.||participants|||Number
847175|NCT00761280|Secondary|Tumor Control Rate (CR+PR+SD) by Independent Review in the Intent-to-treat Population - Percentage of Participants (Descriptive Analysis, Only)|Tumor control rate was defined as the proportion of participants assessed as having Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Participants with unknown or missing response were treated as non-responders.|Up to 24 months|The Intent-to-treat population includes all participants randomized.||percentage of participants||95% Confidence Interval|Number
847176|NCT00761280|Secondary|Overall Response Rate (CR+PR) by Independent Review in the Intent-to-treat Population - Percentage of Participants (Descriptive Analysis, Only)|Overall response rate was the proportion of participants with a best response of Complete Response (CR) or Partial Response (PR) observed from the start of treatment until disease progression.|Up to 24 months|The Intent-to-treat population includes all participants randomized.||percentage of participants||95% Confidence Interval|Number
847205|NCT00745823|Primary|Number of Participants With HIV Ribonucleic Acid (RNA) <50 Copies/mL at 48 Weeks||Week 48|Data were analyzed for all participants treated with study drug. Participants who did not complete the study were treated as treatment failures.||Participants|||Number
847177|NCT00761280|Secondary|Response Category by Independent Review in the Intent-to-treat Population - Number of Participants|"Tumor response was classified based on the (neuro-)radiologist’s evaluation according to the Macdonald Response Criteria for bidimensionally measurable disease as outlined below:
Complete Response (CR): Disappearance of all enhancing tumor on consecutive MRI scans at least 1 month apart, off steroids, neurologically stable or improved.
Partial Response (PR): ≥50% reduction in size of enhancing tumor on consecutive MRI scans at least 1 month apart, steroids stable or reduced, neurologically stable or improved.
Progressive Disease (PD): ≥25% increase in size of enhancing tumor or any new tumor on MRI scans, steroids stable or increased, neurologically worse.
Stable Disease (SD): all other situations.
Two qualified neuro-radiologists reviewed scans at each MRI time point, with adjudication of discrepancies by a third reviewer. Their findings and clinical information were independently reviewed by a neuro-oncologist, who made the assessment of overall response."|Up to 24 months|The Intent-to-treat population includes all participants randomized.||participants|||Number
847178|NCT00761280|Secondary|Median Overall Survival (Days) From Randomization in the Intent-to-treat Population (Descriptive Analysis, Only)|Median overall survival was defined as the date of randomization to the date of death. If a participant's status was unknown and there was no follow-up information available, they were categorized as 'Died' for the purposes of the analysis. Analysis was by Kaplan-Meier estimation.|Up to 24 months|The Intent-to-treat population includes all participants randomized. Early study discontinuation with site closures led to a high proportion of participants being censored or lost to follow-up in the initial analysis. Additional survival data were collected in a post-hoc fashion under a protocol amendment. These data are presented.||days||95% Confidence Interval|Median
847179|NCT00761280|Secondary|Survival at 12, 18, and 21 Months in the Intent-to-treat Population - Number of Participants|"Survival status was assessed at each time-point from randomization. Participants with unknown or missing status were considered treatment failures, i.e., assumed to be dead. The category Lost to follow-up for each time-point includes participants who were alive at the last data collection point but did not yet have enough follow-up time to reach the time point."|12, 18, and 21 months|The Intent-to-treat population includes all participants randomized. Early study discontinuation with site closures led to a high proportion of participants being censored or lost to follow-up in the initial analysis. Additional survival data were collected in a post-hoc fashion under a protocol amendment. These data are presented.||participants|||Number
847180|NCT00761280|Secondary|Survival Rate at 12, 18, and 21 Months in the Intent-to-treat Population - Percentage of Participants (Descriptive Analysis, Only)|Survival rate was defined as the proportion of participants known to be alive at each time-point from randomization. Participants with unknown or missing status were considered treatment failures, i.e., assumed to be dead.|12, 18, and 21 months|The Intent-to-treat population includes all participants randomized. Early study discontinuation with site closures led to a high proportion of participants being censored or lost to follow-up in the initial analysis. Additional survival data were collected in a post-hoc fashion under a protocol amendment. These data are presented.||percentage of participants||95% Confidence Interval|Number
847181|NCT00761280|Primary|Survival Rate at 24 Months in the Intent-to-treat Population - Percentage of Participants (Descriptive Analysis, Only)|Survival rate was defined as the proportion of participants known to be alive at 24 months from randomization. If a participant's status was unknown and there was no follow-up information available, they were categorized as 'Died' for the purposes of the analysis.|24 months|The Intent-to-treat population includes all participants randomized. Early study discontinuation with site closures led to a high proportion of participants being censored or lost to follow-up in the initial analysis. Additional survival data were collected in a post-hoc fashion under a protocol amendment. These data are presented.||percentage of participants||95% Confidence Interval|Number
847182|NCT00759109|Other Pre-specified|Proliferating Cell Nuclear Antigen Labeling Index (PCNA-LI) at Baseline|Liver tissues obtained from biopsies were fixed and immunostained to detect PCNA. PCNA-LI is the percentage of immunohistochemically stained (PCNA positive) cells in 1,000 HCC cells counted. A higher PCNA-LI indicates a worse outcome.|Baseline|ITT population||Score on a scale||Standard Deviation|Mean
847183|NCT00759109|Secondary|Change in the Proliferating Cell Nuclear Antigen Labeling Index (PCNA-LI)|"PCNA-LI was measured at baseline and at 18 months of treatment, and the change in PCNA-LI was calculated.
To measure PCNA-LI, liver tissue samples obtained from biopsies were fixed and immunostained to detect PCNA. PCNA-LI is the percentage of immunohistochemically stained (PCNA positive) cells in 1,000 HCC cells counted. A higher PCNA-LI indicates a worse outcome."|Baseline and at 18 months of treatment|Participants with tissue biopsies at 18 months.||Score on a scale||Standard Deviation|Mean
847184|NCT00759109|Secondary|Number of Patients With a Virological Response Rate|"Virological Response rate was measured by the disappearance of Hepatitis C Virus from serum. Serum samples from participants were analyzed for the
presence of HCV-RNA using a qualitative polymerase chain reaction (PCR)."|Baseline and every year during 3 years of treatment|ITT population||Participants|||Number
847185|NCT00759109|Secondary|Survival Time of Participants|Survival time was defined as time from screening visit to the death of the participant and was studied with Kaplan-Meier and Log-rank tests. If a participant did not die, he or she was censored with the last available date.|During 3 years of treatment and 2 years of follow-up|ITT population||Years||95% Confidence Interval|Median
847186|NCT00759109|Secondary|Number of Participants With Development of Hepatic Decompensation|The development of hepatic decompensation, defined as worsening of the hepatic function as measured by Child Pugh Score. The Child Pugh score was calculated based on biochemical changes (changes in serum albumin, serum bilirubin, prothrombin time) and clinical impairment (ascites, encephalopathies) or both. Each of the 5 parameters was scored from 1-3, and the Child Pugh Score represented the total score. The maximum score was 15, and a score of 10-15 represents the worst outcome and a life expectancy of 1-3 years.|Baseline, During 3 years of treatment and 2 years of follow-up|ITT population||Participants|||Number
847187|NCT00759109|Primary|Number of Participants With the Development of Hepatocellular Carcinoma (HCC)|"Participants were tested for focal lesions by liver ultrasound and for AFP levels every 6 months the during study (treatment and follow-up).
The development of hepatocellular carcinoma was determined by:
the appearance of a focal lesion detected by liver ultrasound with metastases confirmed by fine needle biopsy, or
the appearance of a focal lesion detected by ultrasound + alphafetoprotein (AFP) levels in blood >400 ng/mL."|During 3 years of treatment and 2 years of follow-up|ITT population||Participants|||Number
847188|NCT00756938|Primary|Number of Participants Who Were Discontinued From Study Due to a Clinical and/or Laboratory Adverse Event||up to 12 weeks (Base Study); up to 24 months (Extension)|All Patients as Treated Population, which consisted of all randomized participants who received at least 1 dose of study drug. Adverse events for the base study were reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. Adverse events for the study extension were reported as 1 arm.||Participants|||Number
847189|NCT00756938|Primary|Number of Participants Who Reported 1 or More Clinical and/or Laboratory Adverse Event(s)||up to 12 weeks (Base Study); up to 24 months (Extension)|All Patients as Treated Population, which consisted of all randomized participants who received at least 1 dose of study drug. Adverse events for the base study were reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. Adverse events for the study extension were reported as 1 arm.||Participants|||Number
847190|NCT00756938|Secondary|Mean Change From Baseline in Diastolic Blood Pressure|Sitting BP (or supine if child could not sit) was measured after the participant had been seated for 5 minutes with back supported, feet on the floor and right arm (or left arm if it was the customary side for BP measurement for the patient) supported at heart level. Diastolic BP was determined by averaging 3 replicate measurements obtained at least 1 minute apart.|Baseline and Day 21|Analysis performed using the Full Analysis Set defined as all randomized participants who had at least 1 dose of study drug, had baseline data, and had a post-treatment endpoint observation||mmHg||Standard Deviation|Mean
847191|NCT00756938|Primary|Mean Change From Baseline in Systolic Blood Pressure|Sitting blood pressure ([BP] or supine if child could not sit) was measured after the participant had been seated for 5 minutes with back supported, feet on the floor and right arm (or left arm if it was the customary side for BP measurement for the patient) supported at heart level. Systolic BP was determined by averaging 3 replicate measurements obtained at least 1 minute apart.|Baseline and Day 21|Analysis performed using the Full Analysis Set defined as all randomized participants who had at least 1 dose of study drug, had baseline data, and had a post-treatment endpoint observation||mmHg||Standard Deviation|Mean
847192|NCT00755716|Secondary|MNWS|"Minnesota Nicotine Withdrawing Scale
Scale contains 9 items which are scored 0-4. The total range for the scale is 0-36, where higher scores indicate greater nicotine withdrawal symptoms."|Measured weekly during weeks 7-10 & the mean of weekly measurements is recorded.|Subjects only needed to have an MNWS at one of these time points (weeks 7-10) to be included in the analysis.||units on a scale||Standard Error|Mean
847193|NCT00755716|Primary|Primary Outcome is 4-week Continuous Quit Rate at the End of Treatment.|The primary efficacy endpoint was CO-confirmed cigarette abstinence during the last 4 weeks of treatment.|weeks 7-10|||Participants|||Count of Participants
847194|NCT00752089|Secondary|Adjusted Mean Change From Baseline in Enamel Fluoride Uptake|Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on the amount of fluoride (F) divided by the area of the enamel cores and expressed as ug*F/cm^3. The difference between treatments was calculated with respect to fluoride uptake by enamel.|Baseline to 14 days|"PP population: All randomized participants who received at least one dose of study product, had at least one post-baseline efficacy assessments and no major protocol deviations. Missing data was not imputed. Due to drop-outs, there were differences in the n per treatment group."||ug*F/cm^3||95% Confidence Interval|Least Squares Mean
847195|NCT00752089|Primary|Percentage Surface Micro-hardness Recovery (SMHR) of Enamel Specimens|SMH test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents re-hardening of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline (B), after intra-oral exposure (R) and after in-vitro demineralization (D) using formula: [(D-R)/ (D-B)]*100.|Baseline to 14 days|"Per-Protocol (PP) population: All randomized participants who received at least one dose of study product, had at least one post-baseline efficacy assessments and no major protocol deviations. Missing data was not imputed. Due to drop-outs, there were differences in the n per treatment group."||% SMHR||95% Confidence Interval|Least Squares Mean
847196|NCT00745823|Secondary|Number of Participants Who Discontinued Due to an Adverse Event at 96 Weeks|As the study was terminated after the 48-week analysis, the planned secondary analyses for Week 96 were not performed.|Week 96||||||
847197|NCT00745823|Secondary|Number of Participants With One or More Adverse Events at 96 Weeks|As the study was terminated after the 48-week analysis, the planned secondary analyses for Week 96 were not performed.|Week 96||||||
847198|NCT00745823|Secondary|Mean Change From Baseline to Week 96 in CD4 Cell Count|As the study was terminated after the 48-week analysis, the planned secondary analyses for Week 96 were not performed.|Baseline and Week 96|The Week 96 data analysis was not performed.|||||
847199|NCT00745823|Secondary|Number of Participants With HIV RNA <400 Copies/mL at 96 Weeks|As the study was terminated after the 48-week analysis, the planned secondary analyses for Week 96 were not performed.|Week 96|The Week 96 data analysis was not performed.|||||
847200|NCT00745823|Secondary|Number of Participants With HIV RNA <50 Copies/mL at 96 Weeks|As the study was terminated after the 48-week analysis, the planned secondary analyses for Week 96 were not performed.|Week 96|The Week 96 data analysis was not performed.|||||
847201|NCT00745823|Secondary|Mean Change From Baseline to Week 48 in CD4 Cell Count||Baseline and Week 48|Data were analyzed for all participants treated with study drug. Baseline values were carried forward for participants who discontinued treatment due to lack of efficacy.||cells/mm^3||95% Confidence Interval|Mean
847202|NCT00745823|Primary|Number of Participants Who Discontinued Due to an Adverse Event at 48 Weeks||Week 48|Data were analyzed for all randomized participants who received at least one dose of study drug.||Participants|||Number
847203|NCT00745823|Primary|Number of Participants With One or More Adverse Events at 48 Weeks||Week 48|Data were analyzed for all randomized participants who received at least one dose of study drug.||Participants|||Number
847204|NCT00745823|Secondary|Number of Participants With HIV Ribonucleic Acid (RNA) <400 Copies/mL at 48 Weeks||48 weeks|Data were analyzed for all participants treated with study drug. Participants who did not complete the study were treated as treatment failures.||Participants|||Number
847231|NCT00734539|Secondary|Stage II or Higher Necrotizing Enterocolitis||prior to hospital discharge, up to 15 ½ months|Modified intent-to-treat; only subjects who received at least one dose of study drug.||participants|||Number
847210|NCT00737672|Secondary|Circuit Primary Patency [24 Months] Units Percentage of Subjects|"Kaplan-Meier estimate of the time interval from initial study treatment to abandonment of the vascular access circuit.
Twelve-month estimate of secondary access secondary patency derived from Kaplan-Meier curve."|24 months|Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.||Percentage of Subjects||95% Confidence Interval|Number
847211|NCT00737672|Secondary|Circuit Primary Patency [12 Months] Units Percentage of Subjects|"Kaplan-Meier estimate of the time interval from initial study treatment to abandonment of the vascular access circuit.
Twelve-month estimate of secondary access secondary patency derived from Kaplan-Meier curve."|12months|Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.||Percentage of Subjects||95% Confidence Interval|Number
847212|NCT00737672|Secondary|Circuit Primary Patency|"Kaplan-Meier estimate of the time interval from initial study treatment to the next access thrombosis or intervention performed within the vascular access circuit.
P-Value calculated from 24-month data cohort. Six-month estimate of circuit primary patency derived from Kaplan-Meier curve."|6 months|||Percentage of Subjects||95% Confidence Interval|Number
847213|NCT00737672|Primary|Freedom From Major Device, Procedure and Treatment Site-related Adverse Adverse Events Through 30 Days Post-procedure|The primary safety endpoint is freedom from major device, procedure and treatment site-related adverse events through 30 days.|30 days|||Participants|||Number
847214|NCT00737672|Primary|Target Lesion Primary Patency at 24 Months|"Kaplan-Meier estimate of the time interval of uninterrupted patency from initial study treatment to the next access thrombosis or intervention performed on the target lesion.
P-Value calculated from 24-month data cohort after study completion."|24 Months|Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.||Percentage of Subjects||95% Confidence Interval|Number
847215|NCT00737672|Secondary|Access Secondary Patency [24 Months] Units Percentage of Subjects|"Kaplan-Meier estimate of the time interval from initial study treatment to abandonment of the vascular access circuit.
24-month estimate of secondary access secondary patency derived from Kaplan-Meier curve."|24 months|Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.||Percentage of Subjects||95% Confidence Interval|Number
847216|NCT00737672|Secondary|Access Secondary Patency [12 Months] Units Percentage of Subjects|"Kaplan-Meier estimate of the time interval from initial study treatment to abandonment of the vascular access circuit.
Twelve-month estimate of secondary access secondary patency derived from Kaplan-Meier curve."|12 months|Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.||Percentage of Subjects||95% Confidence Interval|Number
847217|NCT00737672|Secondary|Access Secondary Patency at 6 Months|"Kaplan-Meier estimate of the time interval from initial study treatment to abandonment of the vascular access circuit.
Six-month estimate of secondary access patency derived from Kaplan-Meier curve."|6 months|Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.||Percentage of Subjects||95% Confidence Interval|Number
847218|NCT00737672|Secondary|Assisted Primary Patency at 24 Months|"Kaplan-Meier estimate of the time interval from initial study treatment to occlusion (thrombosis) of the vascular access circuit.
Twenty-four-month estimate of assisted primary patency derived from Kaplan-Meier curve."|24 months|Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.||Percentage of Subjects||95% Confidence Interval|Number
847219|NCT00737672|Secondary|Assisted Primary Patency at 12 Months|"Kaplan-Meier estimate of the time interval from initial study treatment to occlusion (thrombosis) of the vascular access circuit.
Twelve-month estimate of assisted primary patency derived from Kaplan-Meier curve."|12 months|Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.||Percentage of Subjects||95% Confidence Interval|Number
847220|NCT00737672|Secondary|Assisted Primary Patency at 6 Months|"Kaplan-Meier estimate of the time interval from initial study treatment to occlusion (thrombosis) of the vascular access circuit.
Six-month estimate of assisted primary patency derived from Kaplan-Meier curve."|6 months|Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.||Percentage of Subjects||95% Confidence Interval|Number
847221|NCT00737672|Primary|Target Lesion Primary Patency at 12 Months|"Kaplan-Meier estimate of the time interval of uninterrupted patency from initial study treatment to the next access thrombosis or intervention performed on the target lesion.
Twelve-month estimate of target lesion primary patency derived from Kaplan-Meier curve."|12 Months|Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.||Percentage of Subjects||95% Confidence Interval|Number
847222|NCT00737672|Primary|Target Lesion Primary Patency at 6 Months|"Kaplan-Meier estimate of the time interval of uninterrupted patency from initial study treatment to the next access thrombosis or intervention performed on the target lesion.
Six-month estimate of target lesion primary patency derived from Kaplan-Meier curve."|6 months|Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.||Percentage of Subjects||95% Confidence Interval|Number
847223|NCT00734539|Secondary|Intraventricular Hemorrhage|Grade 3 or 4|prior to hospital discharge, up to 15 ½ months|Modified intent-to-treat; only subjects who received at least one dose of study drug.||participants|||Number
847224|NCT00734539|Secondary|Positive Bacterial Infection From a Sterile Site||prior to hospital discharge, up to 15 ½ months|Modified intent-to-treat; only subjects who received at least one dose of study drug.||participants|||Number
847225|NCT00734539|Secondary|Length of Hospitalization||prior to hospital discharge, up to 15 ½ months|Modified intent-to-treat; only subjects who received at least one dose of study drug.||days||Inter-Quartile Range|Median
847226|NCT00734539|Secondary|Retinopathy of Prematurity Requiring Laser Surgery||prior to hospital discharge, up to 15 ½ months|Modified intent-to-treat; only subjects who received at least one dose of study drug.||participants|||Number
847227|NCT00734539|Secondary|Periventricular Leukomalacia||prior to hospital discharge, up to 15 ½ months|Modified intent-to-treat; only subjects who received at least one dose of study drug.||participants|||Number
847228|NCT00734539|Secondary|Patent Ductus Arterious Requiring Surgical Ligation||prior to hospital discharge, up to 15 ½ months|Modified intent-to-treat; only subjects who received at least one dose of study drug.||participants|||Number
847234|NCT00734539|Primary|Death or Candidiasis|"The primary endpoint for the study is death or candidiasis.
Death prior to study day 49.
Candidiasis prior to study day 49
Definite: isolation of Candida from normally sterile body fluid (blood, CSF, urine [obtained via sterile catheterization or suprapubic tap], peritoneal fluid).
Probable:
i. > 5 days of consecutive antifungal therapy
AND both:
ii. Thrombocytopenia <150,000/mm3 iii. Positive Candida culture from nonsterile site (ETS, bag urine)"|study day 49|Modified intent-to-treat; only subjects who received at least one dose of study drug.||participants|||Number
847235|NCT00716976|Secondary|Hearing Loss Among Patients Carrying/Not-carrying Two Key Gene Mutations (TPMT and COMT)||4 weeks after the last dose of cisplatin||01/2018||||
847236|NCT00716976|Secondary|Overall Survival (OS)|Proportion of patients alive free at 4 years following enrollment. See OS outcome measure description.|4 Years after enrollment|61 eligible patients were enrolled on the STS arm; 64 eligible patients were enrolled on the observation arm.||Percentage probability||95% Confidence Interval|Number
847237|NCT00716976|Secondary|Event-Free Survival (EFS)|Proportion of patients event free at 4 years following enrollment. See EFS outcome measure description.|4 years after enrollment|61 eligible patients were enrolled on the STS arm; 64 eligible patients were enrolled on the observation arm.||Percentage probability||95% Confidence Interval|Number
847238|NCT00716976|Secondary|Change in Hearing Thresholds For Key Frequencies at 8000 hz|Mean change in hearing threshold (post-pre) at 8000 hz.|4 weeks after last dose of cisplatin|38 eligible patients in the STS arm had paired audiometry at 8000 hz; 42 patients in the observation arm had paired audiometry at 8000 hz.||Decibels||Standard Deviation|Mean
847239|NCT00716976|Secondary|Change in Hearing Thresholds For Key Frequencies at 4000 hz|Mean change in hearing threshold (post-pre) at 4000 hz.|4 weeks after last dose of cisplatin|38 eligible patients in the STS arm had paired audiometry at 4000 hz; 47 patients in the observation arm had paired audiometry at 4000 hz.||Decibels||Standard Deviation|Mean
847240|NCT00716976|Secondary|Change in Hearing Thresholds For Key Frequencies at 2000 hz|Mean change in hearing threshold (post-pre) at 2000 hz|4 weeks after last dose of cisplatin|38 eligible patients in the STS arm had paired audiometry at 2000 hz; 47 patients in the observation arm had paired audiometry at 2000 hz.||Decibels||Standard Deviation|Mean
847241|NCT00716976|Secondary|Change in Hearing Thresholds For Key Frequencies at 1000 hz|Mean change in hearing threshold (post-pre) at 1000 hz.|4 weeks after last dose of cisplatin|37 eligible patients in the STS arm had paired audiometry at 1000 hz; 47 patients in the observation arm had paired audiometry at 1000 hz.||Decibels||Standard Deviation|Mean
847242|NCT00716976|Secondary|Change in Hearing Thresholds For Key Frequencies at 500 hz|Mean change in hearing threshold (post-pre) at 500 hz.|4 weeks after last dose of cisplatin|38 eligible patients in the STS arm had paired audiometry at 500 hz; 45 patients in the observation arm had paired audiometry at 500 hz.||Decibels||Standard Deviation|Mean
847243|NCT00716976|Primary|Incidence of Hearing Loss|Hearing loss defined by comparing hearing sensitivity at follow up evaluation relative to baseline measurements using ASHA criteria.|4 weeks after last dose of cisplatin|55 eligible patients enrolled on the observation Arm had complete audiometry data for evaluation; 49 eligible patients enrolled on the STS arm had complete data audiometry for evaluation.||Patients|||Number
847244|NCT00708123|Secondary|Adjusted Mean Change From Baseline in Enamel Fluoride Uptake|Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on the amount of fluoride (F) divided by the area of the enamel cores and expressed as ug F/cm2. The difference between treatments was calculated with respect to fluoride uptake by enamel.|Baseline to 14 days|"ITT population: All randomized participants who had a least one post baseline efficacy assessment. Missing data was not imputed. Due to drop outs, there were differences in the n per treatment group."||µg*F/cm^2||Standard Error|Least Squares Mean
847245|NCT00708123|Secondary|Mean %SMHR of Enamel Specimens Exposed to NaF/Carbopol Toothpaste (1400 ppmF), NaF Toothpaste (1350ppmF), NaMFP/NaF Toothpaste (1450ppmF), NaF Toothpaste (250ppmF) and Placebo Toothpaste (0ppmF)|%SMHR test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. %SMHR was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. %SMHR was calculated from indentation values of enamel specimens at baseline (B), after intra-oral exposure (R) and after in-vitro demineralization (D) using formula: [(D-R)/ (D-B)]*100.|Baseline to 14 days|"ITT population: All randomized participants who had at least one post baseline efficacy assessment. Missing data was not imputed. Due to drop outs, there were differences in the n per treatment group."||%SMHR||Standard Error|Least Squares Mean
847246|NCT00708123|Primary|Mean Percentage Surface Microhardness Recovery (%SMHR) of Enamel Specimens Exposed to NaF/Carbopol Toothpaste (1400 ppmF), NaF Toothpaste (1350ppmF) Compared to NaMFP/NaF Toothpaste (1450ppmF)|%SMHR test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. %SMHR was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. %SMHR was calculated from indentation values of enamel specimens at baseline (B), after intra-oral exposure (R) and after in-vitro demineralization (D) using formula: [(D-R)/ (D-B)]*100.|Baseline to 14 days|"Intent to treat population: All randomized participants who had at least one post baseline efficacy assessment. Missing data was not imputed. Due to subject drop outs, there are differences in the n per treatment group."||%SMHR||Standard Error|Least Squares Mean
847247|NCT00708097|Secondary|Enamel Fluoride Uptake (Demineralized Specimens)|Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on the amount of fluoride (F) divided by the area of the enamel cores. The difference between treatments was calculated with respect to fluoride uptake by enamel.|Baseline to 14 days|ITT population: All randomized participants with at least one post baseline efficacy assessment. Missing data was not imputed. Due to drop out there are differences in the number of participants analyzed per treatment group.||μg*F/cm^2||Standard Error|Least Squares Mean
847368|NCT00607126|Primary|Walking Speed as Assessed by 25' Timed Walk|This is the time needed for participant to walk 25 feet. Participant walks on a level surface. the walk from start to finish is timed with a stop watch three measures are done and the average value is entered.|at beginning,mid point, end and 12 weeks after intervention|||seconds||Standard Deviation|Mean
847248|NCT00708097|Secondary|Enamel Fluoride Uptake (Sound Enamel Specimens)|Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on the amount of fluoride (F) divided by the area of the enamel cores. The difference between treatments was calculated with respect to fluoride uptake by enamel.|Baseline to 14 days|ITT population:. All randomized participants who had at least one post baseline efficacy assessment. Missing data was not imputed. Due to drop out there are differences in the number of participants analyzed per treatment group.||micrograms (μg)*F/centimeters(cm)^2]||Standard Error|Least Squares Mean
847249|NCT00708097|Secondary|Percentage SMHR of Demineralized Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), NaF Toothpaste (1400ppmF), NaF Toothpaste (675ppmF), NaMFP/NaF Toothpaste(1450ppmF) and Placebo Toothpaste (0ppmF)|SMH test was used to assess mineral status of partially demineralized enamel specimens using Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening/demineralization while decrease in the indentation represents rehardening/ remineralization of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline(B); after intra-oral exposure(R) on Day 14; and after in-vitro demineralization(D) on Day 14 using formula [(D-R)/(D-B)]*100.|Baseline to 14 days|ITT population. All randomized participants who had at least one post baseline efficacy assessment. Missing data was not imputed. Due to drop out there were differences in the number of participants analyzed per treatment group.||Percentage SMHR||Standard Error|Least Squares Mean
847250|NCT00708097|Secondary|Percentage SMHR of Sound Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), NaF Toothpaste (1400ppmF), NaMFP/NaF Toothpaste (1450ppmF), NaF Toothpaste (675ppmF) and Placebo Toothpaste (0ppmF)|SMH test was used to assess mineral status of partially demineralized enamel specimens using Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening/demineralization while decrease in the indentation represents rehardening/ remineralization of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline(B); after intra-oral exposure(R) on Day 14; and after in-vitro demineralization(D) on Day 14 using formula [(D-R)/(D-B)]*100.|Baseline to 14 days|ITT population: All randomized participants who had at least one post baseline efficacy assessment. Missing data was not imputed. Due to drop out there were differences in the number of participants analyzed per treatment group.||Percentage SMHR||Standard Error|Least Squares Mean
847251|NCT00708097|Primary|Percentage Surface Microhardness Recovery (%SMHR) of Sound Enamel Specimens Exposed to NaF Toothpaste (1450ppmF) and NaF Toothpaste (1400ppmF)|SMH test was used to assess mineral status of partially demineralized enamel specimens using Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening/demineralization while decrease in the indentation represents rehardening/ remineralization of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline(B); after intra-oral exposure(R) on Day 14; and after in-vitro demineralization(D) on Day 14 using formula [(D-R)/(D-B)]*100.|Baseline to 14 days|Intent to Treat (ITT) population: All randomized participants who had at least one post baseline efficacy assessment. Missing data was not imputed. Due to drop outs there were differences in the number of participants (N) per treatment group.||Percentage SMHR||Standard Error|Least Squares Mean
847252|NCT00708305|Secondary|Change From Baseline in Fluoride Concentration at 4 Hours Post Brushing With Study Treatments|Change from baseline at any time point for a treatment period was calculated as the median post brushing fluoride value at a time point minus the median baseline (pre-brushing) fluoride value for a treatment period.|Plaque samples were collected at baseline, 4 hours post single application of study treatment|"PP population: All participants who had at least one post-baseline efficacy assessment but did not have any major protocol deviations. Due to drop outs, there were differences in the n per treatment group. Missing data was not imputed."||μg*F/g||Full Range|Median
847253|NCT00708305|Secondary|Change From Baseline in Fluoride Concentration at 2 Hours Post Brushing With Study Treatments|Change from baseline at any time point for a treatment period was calculated as the median post brushing fluoride value at a time point minus the median baseline (pre-brushing) fluoride value for a treatment period.|Plaque samples were collected at baseline, 2 hour post single application of study treatment|"PP population: All participants who had at least one post-baseline efficacy assessment but did not have any major protocol deviations. Due to drop outs, there were differences in the n per treatment group. Missing data was not imputed."||μg*F/g||Full Range|Median
847254|NCT00708305|Secondary|Change From Baseline in Fluoride Concentration at 1 Hour Post Brushing With Study Treatments|Change from baseline at any time point for a treatment period was calculated as the median post brushing fluoride value at a time point minus the median baseline (pre-brushing) fluoride value for a treatment period.|Plaque samples were collected at baseline, 1 hour post single application of study treatment|"PP population: All participants who had at least one post-baseline efficacy assessment but did not have any major protocol deviations. Due to drop outs, there were differences in the n per treatment group. Missing data was not imputed."||μg*F/g||Full Range|Median
847255|NCT00708305|Secondary|Change From Baseline in Fluoride Concentration at 30 Minutes Post Brushing With Study Treatments|Change from baseline at any time point for a treatment period was calculated as the median post brushing fluoride value at a time point minus the median baseline (pre-brushing) fluoride value for a treatment period.|Plaque samples were collected at baseline, 30 minutes post single application of study treatment|"PP population: All participants who had at least one post-baseline efficacy assessment but did not have any major protocol deviations. Due to drop outs, there were differences in the n per treatment group. Missing data was not imputed."||μg*F/g||Full Range|Median
847256|NCT00708305|Secondary|Change From Baseline in Fluoride Concentration at 15 Minutes After Brushing With Study Treatments|Change from baseline at any time point for a treatment period was calculated as the median post brushing fluoride value at a time point minus the median baseline (pre-brushing) fluoride value for a treatment period.|Plaque samples were collected at baseline, 15 minutes post single application of study treatment|"PP population: All participants who had at least one post-baseline efficacy assessment but did not have any major protocol deviations. Due to drop outs, there were differences in the n per treatment group. Missing data was not imputed."||μg*F/g||Full Range|Median
847257|NCT00708305|Secondary|Natural Log Transformed AUC for Fluoride Concentration in Plaque Fluid Between 0-4 Hours|To evaluate fluoride content, plaque samples were collected from the interproximal surfaces of the posterior teeth of participants using a standardized approach. Plaque fluid fluoride were calculated using a micro analytical method and in comparison to a standard fluoride curve constructed on the same day of the analysis. AUC was determined from 0-4 hours using trapezoidal rule and natural log transformation was applied.due to failure of assumption of normal distribution of data.|Plaque samples collected at 15 minutes, 30 minutes, 1 hour, 2 hours and 4 hours post single application of treatment|"Per-Protocol (PP) population: All participants who had at least one post-baseline efficacy assessment but did not have any major protocol deviations. Due to drop outs, there were differences in the n per treatment group. Missing data was not imputed."||ln(μg*F*minutes/cm^2)||Standard Error|Log Mean
847258|NCT00708305|Primary|Natural Log Transformed Area Under the Fluoride Concentration in Plaque Fluid by Time Curve (AUC) Between 0-4 Hours|To evaluate fluoride content, plaque samples were collected from the interproximal surfaces of the posterior teeth of participants using a standardized approach. Plaque fluid fluoride were calculated using a micro analytical method and in comparison to a standard fluoride curve constructed on the same day of the analysis. AUC was determined from 0-4hours using trapezoidal rule and natural log transformation was applied due to failure of assumption of normal distribution of data.|Plaque samples collected at 15 minutes, 30 minutes, 1 hour, 2 hours and 4 hours post single application of treatment|"Per-Protocol (PP) population: All participants who had at least one post-baseline efficacy assessment but did not have any major protocol deviations. Due to drop outs, there were differences in the n per treatment group. Missing data was not imputed."||ln(μg*F*minutes/cm^2)||Standard Error|Least Squares Mean
847259|NCT00706446|Secondary|Asthma-related Quality of Life||1 year|Data was not collected for secondary outcomes due to study termination.|||||
847260|NCT00706446|Secondary|Symptom-free Days||1 year|Data was not collected for secondary outcomes due to study termination.|||||
847261|NCT00706446|Secondary|Exhaled NO (Nitric Oxide)||1 year|Data was not collected for secondary outcomes due to study termination.|||||
847262|NCT00706446|Secondary|FEV1 (Forced Expiratory Volume)||1 year|Data was not collected for secondary outcomes due to study termination|||||
847263|NCT00706446|Primary|Number of Patients With Asthma Exacerbation||1 year|||Participants|||Count of Participants
847264|NCT00705783|Secondary|Time to Discontinuation|Time to discontinuation was defined as the date of randomization to the date of study discontinuation.|Baseline of the depot maintenance phase to the end of the study (Week 52)|Intent-to-treat population: All randomized patients.||Days||95% Confidence Interval|Median
847265|NCT00705783|Secondary|Mean Clinical Global Impression-Improvement (CGI-I) Score|The efficacy of the study medication was rated for each patient using the CGI-I scale. The rater or investigator rated the patient’s total improvement whether or not it was due entirely to drug treatment. All responses were compared to the patient’s condition at Baseline. Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. The CGI-I score ranged from 0-7 with a higher score indicating less improvement/worsening.|Baseline of the depot maintenance phase to the end of the study (Week 52)|Intent-to-treat population: All randomized patients who had CGI-I scores at both baseline and at least 1 post-baseline time point in Phase 4. Last observation carried forward was implemented to impute the missing data at post-baseline visits. Baseline was not carried forward in imputing the missing data at post-baseline visits.||Units on a scale||Standard Deviation|Mean
847266|NCT00705783|Secondary|Mean Change From Baseline in the PANSS Negative Subscale Score|The PANSS Negative Subscale consists of 7 symptom constructs (blunted affect, emotional withdrawal, poor rapport, passive pathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking). For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. Scores on each subscale ranged from 7-49 with a higher score indicating more severe symptoms. A negative change score indicates improvement.|Baseline of the depot maintenance phase to the end of the study (Week 52)|Intent-to-treat population: All randomized patients who had PANSS sub-scale scores at both baseline and at least 1 post-baseline time point in Phase 4. Last observation carried forward was implemented to impute the missing data at post-baseline visits. Baseline was not carried forward in imputing the missing data at post-baseline visits.||Units on a scale||Standard Error|Least Squares Mean
847267|NCT00705783|Secondary|Mean Change From Baseline in the PANSS Positive Subscale Score|The PANSS Positive Subscale consists of 7 symptom constructs (delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility). For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. Scores on each subscale ranged from 7-49 with a higher score indicating more severe symptoms. A negative change score indicates improvement.|Baseline of the depot maintenance phase to the end of the study (Week 52)|Intent-to-treat population: All randomized patients who had PANSS sub-scale scores at both baseline and at least 1 post-baseline time point in Phase 4. Last observation carried forward was implemented to impute the missing data at post-baseline visits. Baseline was not carried forward in imputing the missing data at post-baseline visits.||Units on a scale||Standard Error|Least Squares Mean
847268|NCT00705783|Secondary|Mean Change From Baseline in the Clinical Global Impression - Severity (CGI-S) Score|The severity of illness for each patient was rated using the CGI-S. To assess CGI-S, the rater or investigator answered the following question: “Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?” Response choices included: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill patients. The CGI-S score ranged from 0-7 with a higher score indicating greater illness. A negative change score indicates improvement.|Baseline of the depot maintenance phase to the end of the study (Week 52)|Intent-to-treat population: All randomized patients who had CGI-S scores at both baseline and at least 1 post-baseline time point in Phase 4. Last observation carried forward was implemented to impute the missing data at post-baseline visits. Baseline was not carried forward in imputing the missing data at post-baseline visits.||Units on a scale||Standard Error|Mean
847269|NCT00705783|Secondary|Mean Change From Baseline in the PANSS Total Score|The PANSS consists of 3 subscales (Positive Subscale, 7 constructs, scores ranged from 7-49, Negative Subscale, 7 constructs, scores ranged from 7-49, General Psychopathology Subscale, 16 constructs, scores ranged from 16-112) containing a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. The PANSS total score ranged from 30-210 with a higher score indicating more severe symptoms. A negative change score indicates improvement.|Baseline of the depot maintenance phase to the end of the study (Week 52)|Intent-to-treat population: All randomized patients who had PANSS total scores at both baseline and at least 1 post-baseline time point in Phase 4. Last observation carried forward was implemented to impute the missing data at post-baseline visits. Baseline was not carried forward in imputing the missing data at post-baseline visits.||Units on a scale||Standard Error|Least Squares Mean
847270|NCT00705783|Secondary|Percentage of Patients Achieving Remission|A patient was considered to have achieved remission if they had a score of ≤ 3 on each of the following PANSS items, maintained for a period of 6 months: Delusions (P1), unusual thought content (G9), hallucinatory behavior (P3), conceptual disorganization (P2), mannerisms/posturing (G5), blunted affect (N1), social withdrawal (N4), and lack of spontaneity (N6).|Baseline of the depot maintenance phase to the end of the study (Week 52)|Intent-to-treat population: All randomized patients who stayed in Phase 4 for at least 6 months and had values for the specific PANSS items P1, G9, P3, P2,G5, N1, N4, and N6.||Percentage of patients|||Number
847271|NCT00705783|Secondary|Percentage of Responders|A patient was considered to be a responder if all of the following criteria were met. 1) Outpatient status, 2) PANSS total score ≤ 80, 3) Lack of specific psychotic symptoms on the PANSS as measured by a score of ≤ 4 on each of the following items (possible scores of 1 to 7 for each item): Conceptual disorganization, suspiciousness, hallucinatory behavior, unusual thought content, and 4) Clinical Global Impression of Severity of Illness (CGI-S) ≤ 4 (moderately ill) and 5) CGI-SS ≤ 2 (mildly suicidal) on Part 1 and ≤ 5 (minimally worsened) on Part 2.|Baseline of the depot maintenance phase to the end of the study (Week 52)|Intent-to-treat (ITT) population: All randomized patients. Two of the 269 patients in the ITT population did not attend the Last Visit at which this Outcome Measure was assessed and were not included in the analysis.||Percentage of patients|||Number
847272|NCT00705783|Secondary|Percentage of Patients Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria|This is the key secondary Outcome Measure.|Baseline of the depot maintenance phase to the end of the study (Week 52)|Intent-to-treat population: All randomized patients.||Percentage of patients|||Number
847273|NCT00705783|Primary|Time to Exacerbation of Psychotic Symptoms/Impending Relapse|A patient experienced an exacerbation of psychotic symptoms/impending relapse if they met any of the following 4 criteria. 1) Clinical Global Impression of Improvement score ≥ 5 and either an increase on any of the following Positive and Negative Syndrome Scale (PANSS) items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content) to a score > 4 with an increase of ≥ 2 on that item since randomization or an increase on any of the same PANSS items to a score > 4 and an increase of ≥ 4 on the same combined PANSS items since randomization, 2) Hospitalization due to worsening of psychotic symptoms, 3) Clinical Global Impression of Severity of Suicide (CGI-SS) score of 4 or 5 on Part 1 and/or 6 or 7 on Part 2, or 4) Violent behavior resulting in clinically significant self-injury, injury to another person, or property damage.|Baseline of the depot maintenance phase to the end of the study (Week 52)|Intent-to-treat population: All randomized patients.||Days||95% Confidence Interval|Median
847274|NCT00700635|Secondary|Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination|Solicited injection site reactions: Erythema, Swelling, Pain. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.|7 days post-vaccination 2|Safety analysis was on all enrolled and vaccinated participants, intent-to-treat population.||Percentage of Participants|||Number
847275|NCT00700635|Secondary|Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination|Solicited injection site reactions: Erythema, Swelling, Pain. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.|7 days post-vaccination 1|Safety analysis was on all enrolled and vaccinated participants, intent-to-treat population.||Percentage of Participants|||Number
847276|NCT00700635|Secondary|Geometric Mean Titers (GMTs) of Meningococcal Antibodies After Each Menactra® Vaccination.|Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by serum bactericidal assay using human complement (SBA-HC)|30 days post-vaccination|Geometric mean titers (GMTs) of Serum Bactericidal Assay Human Complement (SBA-HC) for the vaccine Serogroups were analyzed in the per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
847277|NCT00700635|Secondary|Percentage of Participants With Meningococcal Antibody Titers at ≥ 4 After Each Vaccination|Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by serum bactericidal assay using human complement (SBA-HC)|30 days post-vaccination|Serum bactericidal assay human complement antibody titers to each of the 4 meningococcal serogroups in the vaccine were evaluated in the per-protocol population.||Percentage of Participants|||Number
847278|NCT00700635|Primary|Percentage of Participants With Meningococcal Antibody Titers ≥ 8 After Each Vaccination|Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by serum bactericidal assay using human complement (SBA-HC)|30 days post-vaccination|Serum bactericidal assay human complement antibody titers to each of the 4 meningococcal serogroups in the vaccine were evaluated in the per-protocol population.||Percentage of Participants|||Number
847279|NCT00686725|Secondary|Relationship Between MGMT Status and Therapy Response: PFS for the MGMT Negative Group|"MGMT was measured by IHC.
PFS: The length of time during and after treatment that a participant lived with the cancer but it does not get worse.
PFS was calculated by the Kaplan-Meier method."|Up to 2 years|"Participants with enough tissue to perform MGMT analysis.
Only MGMT-negative participants are included in this outcome measure. MGMT-positive participants are reported in outcome measure 8."||months||Standard Deviation|Median
847280|NCT00686725|Secondary|Relationship Between MGMT Status and Therapy Response: PFS for the MGMT Positive Group|"MGMT was measured by IHC.
PFS: The length of time during and after treatment that a participant lived with the cancer but it does not get worse.
PFS was calculated by the Kaplan-Meier method."|Up to 2 years|"Participants with enough tissue to perform MGMT analysis.
Only MGMT-positive participants are included in this outcome measure. MGMT-negative participants are reported in outcome measure 9."||months||Standard Deviation|Median
847281|NCT00686725|Secondary|Relationship Between MGMT Status and Therapy Response: Overall Survival Rate for the MGMT Negative Group|"MGMT was measured by IHC.
OS rate was defined as the percentage of participants who were still alive 6, 12, & 18 months after starting study treatment.
OS was calculated by the Kaplan-Meier method."|6, 12, & 18 months|"Participants with enough tissue to perform MGMT analysis.
Only MGMT-negative participants are included in this outcome measure. MGMT-positive participants are reported in outcome measure 6."||percentage of participants||95% Confidence Interval|Number
847282|NCT00686725|Secondary|Relationship Between MGMT Status and Therapy Response: Overall Survival Rate for the MGMT Positive Group|"MGMT was measured by IHC.
OS rate was defined as the percentage of participants who were still alive 6, 12, & 18 months after starting study treatment.
OS was calculated by the Kaplan-Meier method."|6, 12, & 18 months|"Participants with enough tissue to perform MGMT analysis.
Only MGMT-positive participants are included in this outcome measure. MGMT-negative participants are reported in outcome measure 7."||percentage of participants||95% Confidence Interval|Number
847283|NCT00686725|Secondary|Relationship Between MGMT Status and Therapy Response: Overall Survival for the MGMT Negative Group|"MGMT was measured by IHC.
OS was defined as the length of time from the start of treatment that 1/2 of the participants were still alive.
OS was calculated by the Kaplan-Meier method."|Up to 2 years|"Participants with enough tissue to perform MGMT analysis.
Only MGMT-negative participants are included in this outcome measure. MGMT-positive participants are reported in outcome measure 4."||months||Standard Deviation|Median
847284|NCT00686725|Secondary|Relationship Between O6-methylguanine-DNA Methyltransferase (MGMT) Status and Therapy Response: Overall Survival for the MGMT Positive Group|"MGMT was measured by immunohistochemistry (IHC).
OS was defined as the length of time from the start of treatment that 1/2 of the participants were still alive.
OS was calculated by the Kaplan-Meier method."|Up to 2 years|"Participants with enough tissue to perform MGMT analysis.
Only MGMT-positive participants are included in this outcome measure. MGMT-negative participants are reported in outcome measure 5."||months||Standard Deviation|Median
847285|NCT00686725|Secondary|Objective Tumor Assessment After Surgery: Overall Response|"Overall response was based on neuroimaging (magnetic resonance imaging [MRI]), clinical neurological examination, and steroid administration.
It was assessed as follows:
Complete Response (CR): Disappearance of all enhancing tumor (measurable
or non-measurable), no corticosteroid use, and neurologically stable or
improved.
Partial Response (PR): ≥50% reduction in size of enhancing tumor
(measurable or non-measurable) for any measurable lesions or definite
improvement for any non-measurable lesions, corticosteroid dosage stable or
reduced, and neurologically stable or improved.
Progressive Disease (PD): ≥25% increase in contrast enhancement for any
measurable lesions or definite worsening for any non-measurable lesions, or
any new tumor on MRI scans, at an increased dose of corticosteroid, with or without neurologic progression. Clinical or radiological worsening resulting from other than tumor factors were excluded.
Stable Disease (SD): All other situations."|Up to 2 years|||participants|||Number
847286|NCT00686725|Secondary|Progression-Free Survival (PFS)|"PFS was defined as the length of time from randomization to disease progression (the length of time during which the cancer did not get worse) or death.
PFS was calculated by the Kaplan-Meier method."|Up to 2 years|||months||95% Confidence Interval|Median
847287|NCT00686725|Primary|Overall Survival (OS)|"OS was defined as the time from randomization to death.
OS was calculated by the Kaplan-Meier method."|Up to 2 years|||months||95% Confidence Interval|Median
847292|NCT00674362|Other Pre-specified|Association Between Disease Activity Score (DAS28-ESR) and Simplified Disease Activity Index (SDAI) Remission at Week 24|The number representing the association is the Kappa Correlation Coefficient for DAS28-ESR/SDAI remission.|Week 24|Of the 194 subjects in the Full Analysis Set (FAS) 142 (76 CZP, 66 Placebo) had measures for both DAS28-ESR and SDAI at Week 24 and are included in this analysis.||Kappa Correlation Coefficient||95% Confidence Interval|Number
847293|NCT00674362|Other Pre-specified|Association Between Clinical Disease Activity Index (CDAI) and Disease Activity Score (DAS28-ESR) Remission at Week 24|The number representing the association is the Kappa Correlation Coefficient for CDAI/DAS28-ESR remission|Week 24|Of the 194 subjects in the Full Analysis Set (FAS) 148 (79 CZP, 69 Placebo) had measures for both CDAI and DAS28-ESR at Week 24 and are included in this analysis.||Kappa Correlation Coefficient||95% Confidence Interval|Number
847467|NCT00555321|Secondary|Summary Statistics for Lipid Parameters- Serum Low Density Lipoprotein Cholesterol (LDL): 12-month Treatment Phase||Baseline (pretransplant), 1, 6, 12 months posttransplant|ITT population, all randomized and transplanted participants. n = participants who had both baseline and postbaseline values.||mg/dL||Standard Deviation|Mean
847294|NCT00674362|Other Pre-specified|Association Between Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) Remission at Week 24|The number representing the association is the Kappa Correlation Coefficient for CDAI/SDAI remission.|Week 24|Of the 194 subjects in the Full Analysis Set (FAS) 143 (76 CZP, 67 Placebo) had measures for both CDAI and SDAI at Week 24 and are included in this analysis.||Kappa Correlation Coefficient||95% Confidence Interval|Number
847295|NCT00674362|Other Pre-specified|Association Between Disease Activity Score (DAS28-ESR) and Simplified Disease Activity Index (SDAI) Activity States at Week 24|The number representing the association is the Kappa Correlation Coefficient for DAS28-ESR/SDAI for each category of activity (Low Disease Activity (LDA) vs. non-LDA, Medium Disease Activity (MDA) vs. non-MDA, and High Disease Activity (HDA) vs. non-HDA).|Week 24|Of the 194 subjects in the Full Analysis Set (FAS) 142 (76 CZP, 66 Placebo) had measures for both DAS28-ESR and SDAI at Week 24 and are included in this analysis.||Kappa Correlation Coefficient||95% Confidence Interval|Number
847296|NCT00674362|Other Pre-specified|Association Between Clinical Disease Activity Index (CDAI) and Disease Activity Score (DAS28-ESR) Activity States at Week 24|The number representing the association is the Kappa Correlation Coefficient for CDAI/DAS28-ESR for each category of activity (Low Disease Activity (LDA) vs. non-LDA, Medium Disease Activity (MDA) vs. non-MDA, and High Disease Activity (HDA) vs. non-HDA).|Week 24|Of the 194 subjects in the Full Analysis Set (FAS) 148 (79 CZP, 69 Placebo) had measures for both CDAI and DAS28-ESR at Week 24 and are included in this analysis.||Kappa Correlation Coefficient||95% Confidence Interval|Number
847297|NCT00674362|Other Pre-specified|Association Between Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) Activity States at Week 24|The number representing the association is the Kappa Correlation Coefficient for CDAI/SDAI for each category of activity (Low Disease Activity (LDA) vs. non-LDA, Medium Disease Activity (MDA) vs. non-MDA, and High Disease Activity (HDA) vs. non-HDA).|Week 24|Of the 194 subjects in the Full Analysis Set (FAS) 143 (76 CZP, 67 Placebo) had measures for both CDAI and SDAI at Week 24 and are included in this analysis.||Kappa Correlation Coefficient||95% Confidence Interval|Number
847298|NCT00674362|Other Pre-specified|Time From Stopping Treatment (Week 24) to First Flare (up to Week 52) Using Clinical Disease Activity Index (CDAI) at 2 Consecutive Visits|Subjects having a flare (CDAI ≥11) between Week 24 and Week 52 for two consecutive visits will be considered as having the event on the day of the visit where flare first appeared.|From Week 24 up to Week 52|"All 194 subjects in the Full Analysis Set (FAS) are included in this analysis.
An ad-hoc analysis has been performed on the Week 24 Responder Set (W24RS) which showed similar results."||days||Standard Error|Mean
847299|NCT00674362|Secondary|Change From Baseline in Fatigue Assessment Scale at Week 24|Change from Baseline in Fatigue Assessment scale (0 to 10, 0 is “No Fatigue” and 10 is “Fatigue as bad as you can imagine”) is computed as the value at Week 24 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 24|Of the 194 subjects, 180 (90 CZP, 90 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method||units on a scale||Standard Deviation|Mean
847300|NCT00674362|Secondary|Change From Baseline in Patient’s Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS) at Week 24|Change from Baseline in Patient’s Global Assessment of Disease Activity-VAS (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as the value at Week 24 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 24|Of the 194 subjects, 183 (92 CZP, 91 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method||mm||Standard Deviation|Mean
847301|NCT00674362|Secondary|Change From Baseline in Patient’s Assessment of Arthritis Pain-Visual Analog Scale (VAS) at Week 24|Change from Baseline in Patient’s Assessment of Arthritis Pain-VAS (0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain) is computed as the value at Week 24 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 24|Of the 194 subjects, 162 (81 CZP, 81 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method||mm||Standard Deviation|Mean
847302|NCT00674362|Secondary|Change From Baseline in Short Form 36-items Health Survey (SF-36) Mental Health Domain at Week 24|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement|Baseline, Week 24|Of the 194 subjects in the Full Analysis Set (FAS), 168 (83 CZP, 85 Placebo) had values at Baseline and Week 24 and are included in this analysis.||units on a scale||Standard Deviation|Mean
847303|NCT00674362|Secondary|Change From Baseline in Short Form 36-items Health Survey (SF-36) Role Emotional Domain at Week 24|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement|Baseline, Week 24|Of the 194 subjects in the Full Analysis Set (FAS), 166 (83 CZP, 83 Placebo) had values at Baseline and Week 24 and are included in this analysis.||units on a scale||Standard Deviation|Mean
847304|NCT00674362|Secondary|Change From Baseline in Short Form 36-items Health Survey (SF-36) Social Functioning Domain at Week 24|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement|Baseline, Week 24|Of the 194 subjects in the Full Analysis Set (FAS), 168 (83 CZP, 85 Placebo) had values at Baseline and Week 24 and are included in this analysis.||units on a scale||Standard Deviation|Mean
847305|NCT00674362|Secondary|Change From Baseline in Short Form 36-items Health Survey (SF-36) Vitality Domain at Week 24|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement|Baseline, Week 24|Of the 194 subjects in the Full Analysis Set (FAS), 168 (83 CZP, 85 Placebo) had values at Baseline and Week 24 and are included in this analysis.||units on a scale||Standard Deviation|Mean
847306|NCT00674362|Secondary|Change From Baseline in Short Form 36-items Health Survey (SF-36) General Health Domain at Week 24|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement|Baseline, Week 24|Of the 194 subjects in the Full Analysis Set (FAS), 166 (82 CZP, 84 Placebo) had values at Baseline and Week 24 and are included in this analysis.||units on a scale||Standard Deviation|Mean
847307|NCT00674362|Secondary|Change From Baseline in Short Form 36-items Health Survey (SF-36) Bodily Pain Domain at Week 24|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement|Baseline, Week 24|Of the 194 subjects in the Full Analysis Set (FAS), 167 (83 CZP, 84 Placebo) had values at Baseline and Week 24 and are included in this analysis.||units on a scale||Standard Deviation|Mean
847308|NCT00674362|Secondary|Change From Baseline in Short Form 36-items Health Survey (SF-36) Role Physical Domain at Week 24|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement|Baseline, Week 24|Of the 194 subjects in the Full Analysis Set (FAS), 167 (83 CZP, 84 Placebo) had values at Baseline and Week 24 and are included in this analysis.||units on a scale||Standard Deviation|Mean
847309|NCT00674362|Secondary|Change From Baseline in Short Form 36-items Health Survey (SF-36) Physical Functioning Domain at Week 24|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement|Baseline, Week 24|Of the 194 subjects in the Full Analysis Set (FAS), 168 (83 CZP, 85 Placebo) had values at Baseline and Week 24 and are included in this analysis.||units on a scale||Standard Deviation|Mean
847310|NCT00674362|Secondary|Change From Baseline in Short Form 36-items Health Survey (SF-36) Mental Component Summary (MCS) Scores at Week 24|MCS norm-based scores are calculated based upon the following 8 domain scores, Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, and range from -9 to 82, where 50 represents the normative value. A larger positive value in change from Baseline indicates an improvement|Baseline, Week 24|Of the 194 subjects in the Full Analysis Set (FAS), 164 (82 CZP, 82 Placebo) had values at Baseline and Week 24 and are included in this analysis.||units on a scale||Standard Deviation|Mean
847311|NCT00674362|Secondary|Change From Baseline in Short Form 36-items Health Survey (SF-36) Physical Component Summary (PCS) Scores at Week 24|PCS norm-based scores are calculated based upon the following 8 domain scores, Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, and range from 1 to 81, where 50 represents the normative value. A larger positive value in change from Baseline indicates an improvement.|Baseline, Week 24|Of the 194 subjects in the Full Analysis Set (FAS), 164 (82 CZP, 82 Placebo) had values at Baseline and Week 24 and are included in this analysis.||units on a scale||Standard Deviation|Mean
847312|NCT00674362|Secondary|Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24|HAQ-DI is derived based on the mean of individual scores in 8 categories of daily living actives (using 20 questions). Each question is scored 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do). Change from Baseline is computed as the value at Week 24 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 24|Of the 194 subjects, 182 (91 CZP, 91 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.||units on a scale||Standard Deviation|Mean
847313|NCT00674362|Secondary|American College of Rheumatology 70% (ACR70) Response at Week 24|ACR70 responders are subjects with at least 70% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. Missing values were imputed using Non-Responder Imputation (NRI)|Baseline, Week 24|Since imputation was used, all 194 subjects are included in the analysis||percentage of subjects|||Number
847314|NCT00674362|Secondary|American College of Rheumatology 50% (ACR50) Response at Week 24|ACR50 responders are subjects with at least 50% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. Missing values were imputed using Non-Responder Imputation (NRI)|Baseline, Week 24|Since imputation was used, all 194 subjects are included in the analysis||percentage of subjects|||Number
847315|NCT00674362|Secondary|American College of Rheumatology 20% (ACR20) Response at Week 24|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. Missing values were imputed using Non-Responder Imputation (NRI)|Baseline, Week 24|Since imputation was used, all 194 subjects are included in the analysis||percentage of subjects|||Number
847363|NCT00611130|Post-Hoc|Medication Compliance|Using retained urine samples and prior to unblinding, up to 12 specimens/ subject were analyzed for vigabatrin levels. Compliance assessment based on > or = 70% of urines in subjects assigned to vigabatrin having quantitative levels of vigabatrin indicaticative of taking drug within the last 24 hours of clinic visit.|Week 2, 4, 6 & 9-11|Completers were defined as those who attended the scheduled Week 13 visit or the third visit of Week 12 and who also had provided urines during Weeks 11 & 12.||participants|||Number
847316|NCT00674362|Secondary|Time From Stopping Treatment (Week 24) to Loss of Remission (up to Week 52) Assessed Using DAS28-ESR Scores at 2 Consecutive Visits|DAS28-ESR is calculated using tender joint count (TJC), swollen joint count (SJC), erythrocyte sedimentation rate (ESR mm/hour) and Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS mm). 0.56x√(TJC) + 0.28x√(SJC) + 0.70xlognat(ESR) + 0.014xPtGADA-VAS. 28 joints are examined. Lower score indicates less disease activity. Patients losing remission (DAS28-ESR≥2.6) for two consecutive visits will be considered as having the event on the first of the two visits. Subjects discontinued/non-remitted by Week 24 are considered as having the event on day 1.|Week 24 up to Week 52|All 194 subjects in the Full Analysis Set (FAS) are included in this analysis.||Days||Standard Deviation|Mean
847317|NCT00674362|Secondary|Time From Stopping Treatment (Week 24) to Loss of Remission (up to Week 52) Assessed Using Simplified Disease Activity Index (SDAI) Scores at 2 Consecutive Visits|SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (mg/dL), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in cm) and Physician's Global Assessment of Disease Activity (PhGADA-VAS in cm). 28 joints are examined. A lower score indicates less disease activity. Patients losing remission (SDAI >3.3) for two consecutive visits will be considered as having the event on the day of the visit where remission was first lost. Subjects discontinued/non-remitted by Week 24 are considered as having the event on day 1.|Week 24 up to Week 52|All 194 subjects in the Full Analysis Set (FAS) are included in this analysis.||days||Standard Deviation|Mean
847318|NCT00674362|Secondary|Time From Stopping Treatment (Week 24) to Loss of Remission (up to Week 52) Assessed Using Clinical Disease Activity Index (CDAI) Scores at 2 Consecutive Visits|CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in cm), and Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in cm). 28 joints are examined where a lower score indicates less disease activity. Patients losing remission (CDAI >2.8) for two consecutive visits will be considered as having the event on the day of the visit where remission was first lost. Subjects discontinued/non-remitted by Week 24 are considered as having the event on day 1.|Week 24 up to Week 52|All 194 subjects in the Full Analysis Set (FAS) are included in this analysis.||days||Standard Deviation|Mean
847319|NCT00674362|Secondary|Simplified Disease Activity Index (SDAI) Remission (≤3.3) at Both Week 20 and Week 24|SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in cm), and Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in cm). 28 joints are examined where a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI)|Week 20 and Week 24|Since imputation was used, all 194 subjects are included in the analysis||percentage of subjects|||Number
847320|NCT00674362|Secondary|28-joint Count Disease Activity Score (DAS28-ESR) Remission (<2.6) at Both Week 20 and Week 24|DAS28-ESR is calculated using the tender joint count (TJC), swollen joint count (SJC) erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Patient Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI)|Week 20 and Week 24|Since imputation was used, all 194 subjects are included in the analysis||percentage of subjects|||Number
847321|NCT00674362|Primary|Clinical Disease Activity Index (CDAI) Remission (≤2.8) at Both Week 20 and Week 24|CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in cm), and Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in cm). 28 joints are examined where a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI)|Week 20 and Week 24|All 194 subjects in the Full Analysis Set (FAS) are included in this analysis.||percentage of subjects|||Number
847364|NCT00611130|Primary|Proportion of Subjects in Each Treatment Group Abstinent During the Last 2 Weeks of Treatment.|Number of subjects in the CPP-109 Vigabatrin Group vs. Number in Placebo Group abstinent from using cocaine during Weeks 11 and 12 of the Treatment Phase.|Week 13|intent-to-treat||participants|||Number
847330|NCT00646646|Primary|Dynamic Eye Movement Measures|Change in Eye Movements Parameters|baseline to Sedation State (approx. 1 hr)|||(degrees/second)||95% Confidence Interval|Mean
847331|NCT00645944|Primary|Change in Insomnia Severity Index From Baseline.|The Insomnia Severity Index (ISI) is a 7-item self-report questionnaire that provides a global measure of insomnia severity based on several indicators (e.g., difficulty falling or staying asleep, satisfaction with sleep, degree of impairment with daytime functioning). It has adequate internal consistency (Cronbach’s alpha=0.91) and temporal stability (r=0.80), has been validated against sleep diary and polysomnography data and was sensitive to change in several insomnia treatment studies. The ISI scale range is: minimum = 0, maximum = 28. The interpretation is that lower is 'better sleep', while higher is considered 'worse sleep/more insomnia'.|8 Weeks|Of 39 eligible participants, 19 were randomized to placebo and 20 to eszopiclone 3mg. Two participants in the placebo arm and 1 participant in the eszopiclone arm withdrew before receiving study medication. 36 participants were included in the modified ITT analysis||units on a scale||95% Confidence Interval|Least Squares Mean
847339|NCT00643565|Secondary|Clearance of Bevacizumab|CL is a quantitative measure of the rate at which a drug substance is removed from the body. CL is expressed in milliliters per day (mL/day).|Pre- and within 3 hours post-dose on Days 1, 8, and 15 of Cycle 1, Day 1 of Cycle 2-4 of induction phase (1 cycle = 3 weeks)|PK-evaluable population. Only participants who received bevacizumab were to be analyzed for PK assessment.||mL/day||Standard Deviation|Mean
847340|NCT00643565|Secondary|Half-Life of Bevacizumab|Half-life is the time measured for the plasma concentration to decrease by one half.|Pre- and within 3 hours post-dose on Days 1, 8, and 15 of Cycle 1, Day 1 of Cycle 2-4 of induction phase (1 cycle = 3 weeks)|PK-evaluable population. Only participants who received bevacizumab were to be analyzed for PK assessment.||days||Standard Deviation|Mean
847341|NCT00643565|Secondary|Volume of Distribution of Bevacizumab|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.|Pre- and within 3 hours post-dose on Days 1, 8, and 15 of Cycle 1, Day 1 of Cycle 2-4 of induction phase (1 cycle = 3 weeks)|PK-evaluable population. Only participants who received bevacizumab were to be analyzed for PK assessment.||mL||Standard Deviation|Mean
847342|NCT00643565|Secondary|Area Under the Curve at Steady State (AUCss) of Bevacizumab|AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. AUCss is expressed in milligrams times days per milliliter (mg*day/mL).|Pre- and within 3 hours post-dose on Days 1, 8, and 15 of Cycle 1, Day 1 of Cycle 2-4 of induction phase|Pharmacokinetic (PK)-evaluable population included all randomized participants for whom at least one blood sample was taken for PK assessment following bevacizumab administration. Here, number of participants analyzed = participants who were evaluable for this outcome measure.||mg*day/mL||Standard Deviation|Mean
848713|NCT00602836|Secondary|Number of Participants With ZAP-70 Testing at Baseline Who Also Had a Clinical Response (CR, nPR, or PR).|Response categories described in above outcome measures. ZAP-70 status describe in baseline characteristics section.|During treatment (up to 5 years)||||||
847343|NCT00643565|Secondary|Overall Survival Duration|Overall survival was defined as the time between randomization and death due to any cause. Participants without an event were censored at the last time they were known to be alive. Median overall survival was estimated using Kaplan-Meier estimates and 95% CI for median was computed using the method of Brookmeyer and Crowley.|Screening up to approximately 6.75 years (assessed at screening, Cycles 4, 7 of induction phase, Cycles 1, 4, 7, 10 of maintenance, then every 3 months for 1.5 years and thereafter every 6 months for 2.5 years up to data cut-off date 31 May 2015)|ITT population.||months||95% Confidence Interval|Median
847344|NCT00643565|Primary|EFS Duration as Per IRC Assessment|EFS was defined as the time between randomization and occurrence of EFS event. EFS events are described in Outcome Measure 1. Median EFS was estimated using Kaplan-Meier estimates and 95% confidence intervals (CI) for median was computed using the method of Brookmeyer and Crowley.|Screening up to approximately 6.75 years (assessed at screening, Cycles 4, 7 of induction phase, Cycles 1, 4, 7, 10 of maintenance, then every 3 months for 1.5 years and thereafter every 6 months for 2.5 years up to data cut-off date 31 May 2015)|ITT population.||months||95% Confidence Interval|Median
847345|NCT00643565|Secondary|Percentage of Participants Who Died||Screening up to approximately 6.75 years (assessed at screening, Cycles 4, 7 of induction phase, Cycles 1, 4, 7, 10 of maintenance, then every 3 months for 1.5 years and thereafter every 6 months for 2.5 years up to data cut-off date 31 May 2015)|ITT population.||percentage of participants|||Number
847346|NCT00643565|Secondary|Duration of Response|Duration of Response was defined as time between first objective response and the occurrence of an EFS event (described in Outcome Measure 1). Objective response was defined in Outcome Measure 3. Median duration of response was estimated using Kaplan-Meier estimates and 95% CI for median was computed using the method of Brookmeyer and Crowley.|Screening up to approximately 6.75 years (data cut-off date 31 May 2015)|ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.||months||95% Confidence Interval|Median
847347|NCT00643565|Secondary|Percentage of Participants Who Experienced EFS Events Among Participants Who Had Objective Response|EFS events was described in Outcome Measure 1 and Outcome Measure 3.|Screening up to approximately 6.75 years (data cut-off date 31 May 2015)|ITT population. Here number of participants analyzed = participants available for the analysis of this outcome measure.||percentage of participants|||Number
847348|NCT00643565|Secondary|Percentage of Participants With Objective Response Prior to First Local Therapy Assessed by RECIST v1.0 Criteria|Objective response prior to first local therapy (surgery and/or radiotherapy) was defined as complete response (CR) or partial response (PR) determined on two consecutive occasions >/=4 weeks apart. Tumor response was assessed as per IRC using RECIST v1.0. CR was defined as disappearance of all target and non-target lesions. If immunocytology was available, no disease was to be detected by that methodology. PR was defined as at least a 30% decrease in the disease measurement, taking as reference the disease measurement done to confirm measurable disease at study entry.|Screening up to approximately 6.75 years (data cut-off date 31 May 2015)|ITT population.||percentage of participants||95% Confidence Interval|Number
847349|NCT00643565|Primary|Percentage of Participants Who Experienced Event-Free Survival (EFS) Events as Per Independent Review Committee (IRC) Assessment|EFS events included tumor progression (IRC assessed), no evidence of response after 3 cycles of induction (derived from IRC assessment), second primary cancer, or death due to any cause. Data for participants who had not experienced an event by the time of clinical cut-off were censored at the date of the last disease assessment prior to the clinical cut-off date. Data for participants who did not have any post-baseline disease assessments were censored at the time of randomization. Tumor progression was defined using Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0) as at least a 20% increase in the disease measurement, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions, or evidence of clinical progression and unequivocal progression of existing non-target lesions.|Screening up to approximately 6.75 years (assessed at screening, Cycles 4, 7 of induction phase, Cycles 1, 4, 7, 10 of maintenance, then every 3 months for 1.5 years and thereafter every 6 months for 2.5 years up to data cut-off date 31 May 2015)|ITT population.||percentage of participants|||Number
847350|NCT00623766|Secondary|Overall Survival (OS)|OS is defined as the time from date of first dose of study drug until the date of death. For those patients who did not die, OS was censored at the recorded last date of patient contact, and those missing a recorded last date of contact will be censored at the last date the patient was known to be alive.|From first dose to 24 months|All participants who received at least 1 dose of ipilimumab||Months||95% Confidence Interval|Median
847351|NCT00623766|Secondary|Onset of Response by Modified World Health Organization (mWHO) Criteria and Immune-related Response Criteria (irRC)|Onset of response is defined as the time between the first dose of study therapy and the date when measurement criteria are first met for global best overall response of partial (PR) or complete (CR), whichever occurs first. CR=complete disappearance of all index lesions. PR=decrease, relative to baseline, of 50% or greater in the sum of the 2 largest perpendicular diameters of all index lesions.|From Day 1, first dose to a maximum of 4.2 months|All participants who received at least 1 dose of ipilimumab. n=number of participants with a best overall response of CR or PR.||Months||Full Range|Median
847352|NCT00623766|Secondary|Number of Participants Who Died or Had a Treatment-related Adverse Event (AE), Immune-related AE, Immune-related Serious Adverse Event (SAE), Nervous System Disorder, Treatment-related Nervous System Disorder, SAE, and AE Leading to Discontinuation|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.|Continuously from Day 1, first dose, to 70 days following last dose of ipilimumab|All participants who received at least 1 dose of ipilimumab||Participants|||Number
847365|NCT00607126|Secondary|PASAT|Cognitive measure of attention and information processing speed. Score goes from 0-60 with higher number indicating better performance. Scores are expressed as mean chamge rfom baseline; negative numbers indicate worse performance|baseline, mid, completion, 3 months post training|||units on a scale||Standard Error|Mean
847353|NCT00623766|Secondary|Number of Participants Surviving at 6, 12, 18, 24, and 36 Months (Overall Survival [OS] Rate)|OS is defined as the time from the first dose of study drug until the date of death. Overall survival rate is the percentage of participants known to be alive at a timepoint. For those patients who did not die, OS was censored at the recorded last date of patient contact, and those with a missing recorded last date of contact will be censored at the last date the patient was known to be alive. The survival rate at a specified time-point is the probability that a patient is alive at that time following randomization. The rate is calculated for each treatment group using the Kaplan-Meier product-limit method. A corresponding 2-sided 95% bootstrap confidence interval will be calculated.|From first dose to Months 6, 12, 18, 24, and 36 months|All participants who received at least 1 dose of ipilimumab||Probability of being alive||95% Confidence Interval|Number
847354|NCT00623766|Secondary|Progression-free Survival (PFS) by Modified World Health Organization (mWHO) Criteria and by Immune-related Response Criteria (irRC)|PFS is defined as the time between the date of the first dose of study therapy and the date of progression or death, whichever occurs first. A patient who dies without reported prior progression will be considered to have progressed on the date of death. For those who remain alive and have not progressed, PFS will be censored on the date of last evaluable tumor assessment. Participants who have not died and have no recorded postbaseline tumor assessment will be censored on the date of first dose of study therapy. Those who die without any recorded postbaseline tumor assessment will be considered to have progressed on the date of death.|From Day 1, first dose to the date of progression or death, whichever occurred first up to 22 months|All participants who received at least 1 dose of ipilimumab||Months||95% Confidence Interval|Median
847355|NCT00623766|Secondary|Duration of Response (DOR) by Modified World Health Organization (mWHO) Criteria and by Immune-related Response Criteria (irRC)|DOR is defined in patients whose global best overall response is complete (CR) or partial response (PR) as the time between the date of response of confirmed CR or PR, whichever occurs first, and the date of progressive disease or death, whichever occurs first. For patients who remain alive and have not progressed following response, duration of response will be censored on the date of last evaluable tumor assessment.|From Day 1, first dose to last tumor assessment up to 18.2 months|All participants who received at least 1 dose of ipilimumab||Months||95% Confidence Interval|Median
847356|NCT00623766|Secondary|Best Overall Response Rate (BORR) by Modified World Health Organization (mWHO) Criteria and by Immune-relate Response Criteria (irRC)|BORR is defined as the number of patients whose global best overall response (BOR) was complete (CR) or partial response (PR), divided by the total number of participants who received treatment. CR=complete disappearance of all index lesions. PR=decrease, relative to baseline, of 50% or greater in the sum of the products of the 2 largest perpendicular diameters of all index lesions. The global BOR is the best overall response (OR) designation over the study as a whole for an individual in the study based on overall tumor burden. Both central nervous system (CNS) (brain lesions) and non-CNS compartments (lesions outside the brain) are considered for the global BOR. For the analysis of global BOR of CR or PR (by both modified WHO criteria and immune-related response criteria [irRC]), the OR assessment must be confirmed by a second (confirmatory) evaluation meeting the criteria for response and must be performed no less than 4 weeks after the criteria for response are first met.|From Day 1, first dose until the last tumor assessment, Week 12|All participants who received at least 1 dose of ipilimumab||Percentage of participants||95% Confidence Interval|Number
847357|NCT00623766|Secondary|Disease Control Rate by Immune-related Response Criteria (irRC)|Disease control rate is defined as the number of patients with a best overall response of immune-related (ir) complete response (irCR), partial response (irPR), or stable disease (irSD) divided by the total number of patients who received treatment. By irRC definition: irCR=complete disappearance of all index lesions. irPR=decrease, relative to baseline, of 50% or greater in the sum of the products of the 2 largest perpendicular diameters of all index lesions. irSD=does not meet criteria for irCR or irPR, in the absence of ir progressive disease (irPD). irPD=at least 25% increase in the sum of the products of all index lesions (taking as reference the smallest sum recorded at or following baseline). CNS=central nervous system; non-CNS compartment=extracranial, or outside of the brain.|From Day 1, first dose to end of Week 12|All participants who received at least 1 dose of ipilimumab||Percentage of participants||95% Confidence Interval|Number
847358|NCT00623766|Primary|Disease Control Rate by Modified World Health Organization (mWHO) Tumor Assessment Criteria|Disease control rate is defined as the number of patients with a best overall response of complete response (CR), partial response (PR), or stable disease (SD) (global, in brain, or outside of brain) based on mWHO criteria divided by the number of patients who received treatment. By mWHO criteria: CR=complete disappearance of all index lesions. PR=decrease, relative to baseline, of 50% or greater in the sum of the 2 largest perpendicular diameters of all index lesions. SD=does not meet criteria for CR or PR, in the absence of progressive disease (PD). Patients with PR or CR not confirmed after at least 4 weeks are scored as SD unless they have new primary lesions. PD=at least 25% increase in the sum of the diameters of all index lesions (taking as reference the smallest sum recorded at or following baseline) and/or the appearance of any new lesions. CNS=central nervous system.|From Day 1, first dose to end of Week 12|All participants who received at least 1 dose of ipilimumab||Percentage of participants||95% Confidence Interval|Number
847359|NCT00612560|Secondary|Growth Hormone Serum Levels IGF-1|Mean serum level IGF-1(pg/ml)|Biopsy/Week 1 and Surgical Resection/Week 2|All treated and eligible patients with a large enough of a sample for analysis||pg/ml||Standard Deviation|Mean
847360|NCT00612560|Primary|Human Epidermal Growth Factor Receptor 2 (Her2) Expression|Mean percentage of cells expressing human epidermal growth factor receptor 2 (Her2)|Biopsy/Week 1 and Surgical Resection/Week 2|All treated and eligible patients with a large enough of a sample for analysis.||percentage of cells||Standard Deviation|Mean
847361|NCT00612560|Primary|Progesterone Receptor (PR) Expression|Mean percentage of cells expressing PR|Biopsy/Week 1 and Surgical Resection/Week 2|All treated and eligible patients with a large enough of a sample for analysis||percentage of cells||Standard Deviation|Mean
847362|NCT00612560|Primary|Expression of Estrogen Receptor (ER-beta)|Mean percentage of cells expressing estrogen receptor (ER-beta)|Biopsy/Week 1 and Surgical Resection/Week 2|All treated and eligible patients with a large enough of a sample for analysis||percentage of cells||Standard Deviation|Mean
847366|NCT00607126|Secondary|Fatigue|fatigue assessed by modified fatigue impact scale. This is a 21 item questionnaire which has a range from 0-84. Higher scores indicate more impact of fatigue on physical and cognitive functioning.|baseline, mid, completetion, 3 months post|||units on a scale||Standard Deviation|Mean
847369|NCT00604175|Secondary|Change in CD4 Cell Count From Baseline|A blood sample was drawn for local testing to determine the CD4 cell count. Change in CD4 cell count was calculated as CD4 cell count at a later time point (Weeks 4, 8, 12, 24, 28, 52 and 72) minus CD4 cell count at baseline.|Weeks 0, 4, 8, 12, 24, 28, 52 and 72|N=315 eligible participants who initiated intervention and had data available at Week 0 and the respective follow-up week. Strata A; B; C. Week 4: n=122; 92; 88. Week 8: n=119; 92; 90. Week 12: n=115; 87; 90. Week 24: n=117; 85; 88. Week 28: n=114; 89; 87. Week 52: n=108; 85; 87. Week 72: 105; 85; 88.||Cells/mm^3||Inter-Quartile Range|Median
847370|NCT00604175|Secondary|Change in Log10 HIV Viral Load (VL) From Baseline|A blood sample was drawn for local testing to determine the HIV VL. Change in log10 HIV VL was calculated as log10 HIV VL at a later time point (Weeks 4, 12, 28, 52 and 72) minus log10 HIV VL at baseline.|Weeks 0, 4, 12, 28, 52, and 72|N=315 eligible participants who initiated intervention and had HIV VL available at Week 0 and the respective follow-up week. Strata A; B; C. Week 4: n=123; 89; 88. Week 12: n=118; 89; 90. Week 28: n=118; 91; 87. Week 52: n=109; 85; 82. Week 72: n=105; 81; 83.||Log10 copies/mL||Inter-Quartile Range|Median
847371|NCT00604175|Secondary|Number of Participants With Laboratory Abnormalities of Grade 3 or Higher|Number of participants who experienced a laboratory abnormality of Grade 3 or higher at any time after baseline while on study. Grading of laboratory abnormalities was according to Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, December 2004.|From baseline to up to Week 72|All eligible participants who received at least one vaccine.||Participants|||Number
847372|NCT00604175|Secondary|Number of Participants With Signs and Symptoms of Grade 3 or Higher|Number of participants who experienced a sign or symptom of Grade 3 or higher at any time after baseline while on study. Grading of signs and symptoms was according to Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, December 2004.|From baseline to up to Week 72|All eligible participants who received at least one vaccine.||Participants|||Number
847373|NCT00604175|Secondary|Change in Log10 HPV18 Antibody Titers From Baseline Among Those Seropositive for HPV18 at Baseline|Change in log10 HPV18 antibody titers was calculated as log10 HPV18 antibody titers at a later timepoint (Week 28, Week 72) minus log10 HPV18 antibody titers at baseline among those seropositive for HPV18 (>=24 mMU/mL) at baseline. HPV antibody titers to type 18 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (10 mMU/mL for HPV18).|Weeks 0, 28, 72|All eligible participants who received at least one vaccine and were seropositive for HPV18 at baseline (the number of participants analyzed) and had HPV18 titer available at the respective follow-up week. Strata A; B; C. Week 28: n=27; 11; 19. Week 72: n=25; 11; 19.||Log10 mMU/mL||Inter-Quartile Range|Median
847374|NCT00604175|Secondary|Change in Log10 HPV16 Antibody Titers From Baseline Among Those Seropositive for HPV16 at Baseline|Change in log10 HPV16 antibody titers was calculated as log10 HPV16 antibody titers at a later timepoint (Week 28, Week 72) minus log10 HPV16 antibody titers at baseline among those seropositive for HPV16 (>=20 mMU/mL) at baseline. HPV antibody titers to type 16 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (11 mMU/mL for HPV16).|Weeks 0, 28, 72|All eligible participants who received at least one vaccine and were seropositive for HPV16 (HPV16+) at baseline (the number of participants analyzed) and had HPV16 titer available at the respective follow-up week. Strata A; B; C. Week 28: n=40; 28; 24. Week 72: n=37; 25; 24.||Log10 mMU/mL||Inter-Quartile Range|Median
847375|NCT00604175|Secondary|Change in Log10 HPV11 Antibody Titers From Baseline Among Those Seropositive for HPV11 at Baseline|Change in log10 HPV11 antibody titers was calculated as log10 HPV11 antibody titers at a later timepoint (Week 28, Week 72) minus log10 HPV11 antibody titers at baseline among those seropositive for HPV11 (>=16 mMU/mL) at baseline. HPV antibody titers to type 11 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (8 mMU/mL for HPV11).|Weeks 0, 28, 72|All eligible participants who received at least one vaccine and were seropositive for HPV11 (HPV11+) at baseline (the number of participants analyzed) and had HPV11 titer available at the respective follow-up week. Strata A; B; C. Week 28: n=20; 21; 17. Week 72: n=17; 18; 19.||Log10 mMU/mL||Inter-Quartile Range|Median
847376|NCT00604175|Secondary|Change in Log10 HPV6 Antibody Titers From Baseline Among Those Seropositive for HPV6 at Baseline|Change in log10 HPV6 antibody titers was calculated as log10 HPV6 antibody titers at a later timepoint (Week 28, Week 72) minus log10 HPV6 antibody titers at baseline among those seropositive for HPV6 (>=20 mMU/mL) at baseline. HPV antibody titers to type 6 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (7 mMU/mL, and after assay change in December 2012, 11 mMU/mL for HPV6).|Weeks 0, 28, 72|All eligible participants who received at least one vaccine and were seropositive for HPV6 (HPV6+) at baseline (the number of participants analyzed) and had HPV6 titer available at the respective follow-up week. Strata A; B; C. Week 28: n=52; n=33; n=36. Week 72: n=43; 31; 35.||Log10 mMU/mL||Inter-Quartile Range|Median
847377|NCT00604175|Secondary|HPV18 Antibody Titers Among Those Seronegative for HPV18 at Baseline|HPV antibody titers to type 18 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (10 mMU/mL for HPV18). Geometric mean HPV18 titers with 95% CIs were calculated among the subset of participants who were seronegative for HPV18 (<24 mMU/mL) at baseline.|Weeks 28, 72|All eligible participants who received at least one vaccine and were seronegative for HPV18 (HPV18-) at baseline (the number of participants analyzed) and had HPV18 titer available at the respective follow-up week. Strata A; B; C. Week 28: n=86; 80; 69. Week 72: n=75; 73; 69.||mMU/mL||95% Confidence Interval|Geometric Mean
847378|NCT00604175|Secondary|HPV16 Antibody Titers Among Those Seronegative for HPV16 at Baseline|HPV antibody titers to type 16 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (11 mMU/mL for HPV16). Geometric mean HPV16 titers with 95% CIs were calculated among the subset of participants who were seronegative for HPV16 (<20 mMU/mL) at baseline.|Weeks 28, 72|All eligible participants who received at least one vaccine and were seronegative for HPV16 (HPV16-) at baseline (the number of participants analyzed) and had HPV16 titer available at the respective follow-up week. Strata A; B; C. Week 28: n=73; 63; 64. Week 72: n=63; 59; 64.||mMU/mL||95% Confidence Interval|Geometric Mean
847379|NCT00604175|Secondary|HPV11 Antibody Titers Among Those Seronegative for HPV11 at Baseline|HPV antibody titers to type 11 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (8 mMU/mL for HPV11). Geometric mean HPV11 titers with 95% CIs were calculated among the subset of participants who were seronegative for HPV11 (<16 mMU/mL) at baseline.|Weeks 28, 72|All eligible participants who received at least one vaccine and were seronegative for HPV11 (HPV11-) at baseline (the number of participants analyzed) and had HPV11 titer available at the respective follow-up week. Strata A; B; C. Week 28: n=93; 70; 71. Week 72: n=83; 66; 69.||mMU/mL||95% Confidence Interval|Geometric Mean
847380|NCT00604175|Secondary|HPV6 Antibody Titers Among Those Seronegative for HPV6 at Baseline|HPV antibody titers to type 6 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (7 mMU/mL, and after assay change in December 2012, 11 mMU/mL for HPV6). Geometric mean HPV6 titers with 95% CIs were calculated among the subset of participants who were seronegative for HPV6 (<20 mMU/mL) at baseline.|Weeks 28, 72|All eligible participants who received at least one vaccine and were seronegative for HPV6 (HPV6-) at baseline (the number of participants analyzed) and had HPV6 titer available at the respective follow-up week. Strata A; B; C. Week 28: n=60; 58; 52. Week 72: n=55; 53; 53.||mMU/mL||95% Confidence Interval|Geometric Mean
847381|NCT00604175|Primary|Percentage of Participants With HPV18 Antibody Development From the Seronegative Status at Baseline to Seropositive Status a Month After Completion of HPV Vaccination Series|Percentage of participants with HPV18 antibody development from seronegative status (HPV18 antibody titers <24 mMU/mL) at baseline to seropositive (HPV18 antibody titers >=24 mMU/mL) status a month after the completion of HPV vaccination series. HPV serotyping was performed centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum.|Week 28|Per-protocol analysis including all participants seronegative to HPV18 at baseline who completed the vaccination series per protocol and had HPV18 titer available at Week 28.||Percentage of participants||95% Confidence Interval|Number
847382|NCT00604175|Primary|Percentage of Participants With HPV16 Antibody Development From Seronegative Status at Baseline to Seropositive Status a Month After Completion of HPV Vaccination Series|Percentage of participants with HPV16 antibody development from seronegative status (HPV16 antibody titers <20 mMU/mL) at baseline to seropositive (HPV16 antibody titers >=20 mMU/mL) status a month after the completion of HPV vaccination series. HPV serotyping was performed centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum.|Week 28|Per-protocol analysis including all participants seronegative to HPV16 at baseline who completed the vaccination series per protocol and had HPV16 titer available at Week 28.||Percentage of participants||95% Confidence Interval|Number
847383|NCT00604175|Primary|Percentage of Participants With HPV11 Antibody Development From Seronegative Status at Baseline to Seropositive Status a Month After Completion of HPV Vaccination Series|Percentage of participants with HPV11 antibody development from seronegative status (HPV11 antibody titers <16 mMU/mL) at baseline to seropositive (HPV11 antibody titers >=16 mMU/mL) status a month after the completion of HPV vaccination series. HPV serotyping was performed centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum.|Week 28|Per-protocol analysis including all participants seronegative to HPV11 at baseline who completed the vaccination series per protocol and had HPV11 titer available at Week 28.||Percentage of participants||95% Confidence Interval|Number
847384|NCT00604175|Primary|Percentage of Participants With HPV6 Antibody Development From Seronegative Status at Baseline to Seropositive Status a Month After Completion of HPV Vaccination Series|Percentage of participants with HPV6 antibody development from seronegative status (HPV6 antibody titers <20 mMU/mL) at baseline to seropositive (HPV6 antibody titers >=20 mMU/mL) status a month after the completion of HPV vaccination series. HPV serotyping was performed centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum.|Week 28|Per-protocol analysis including all participants seronegative to HPV6 at baseline who completed the vaccination series per protocol and had HPV6 titer available at Week 28.||Percentage of participants||95% Confidence Interval|Number
847385|NCT00603902|Secondary|Percent Change in Body Weight From Baseline to Week 52|The % change in body weight (kg) from baseline to week 52.|52 weeks|MITT with LOCF||% change from baseline: body wt (kg)||Standard Error|Least Squares Mean
847386|NCT00603902|Primary|Co-primary Endpoint- Proportion (%) of Patients Achieving > or = 5% Weight Loss From Baseline to Week 52|"The proportion of patients with a reduction from baseline body weight of 5% or more after 52 weeks.
Other co-primary endpoints are change from baseline in body weight (kg) at year 1 and the proportion of patients achieving ≥ 10% reduction in body weight at year 1."|52 weeks|MITT with LOCF||percentage of participants|||Number
847387|NCT00603291|Secondary|Percent Change in Body Weight From Baseline to Week 52|The % change in body weight (kg) from baseline to week 52.|52 weeks|MITT with LOCF||% change from baseline: body wt (kg)||Standard Error|Least Squares Mean
847388|NCT00603291|Primary|Co-primary Endpoint- Proportion (%) of Patients Achieving > or = 5% Weight Loss From Baseline to Week 52|"The proportion of patients with a reduction from baseline body weight of 5% or more after 52 weeks.
Other co-primary endpoints are change from baseline in body weight (kg) at year 1 and the proportion of patients achieving ≥ 10% reduction in body weight at year 1."|52 weeks|MITT with LOCF||percentage of participants|||Number
847400|NCT00582790|Secondary|Number of Participants With Immunologic Responses|Blood was collected to analyze T-cell populations from all patients prior to treatment on day 1 of cycles 1 and 2, and days 4 and 8 of cycles 1 and 2. Changes in gamma delta T-cell population and CD3 T-cell populations were reported.|baseline to cycle 2 day 8|One patient did not receive study treatment and so was not included in the analysis.||participants|||Number
847401|NCT00582790|Secondary|Number of Participants With Toxicities|Patients were observed for toxicities. The National Cancer Institute Common Terminology Criteria Version 2.0 was used to categorize and report adverse events.|Baseline to 30 days after last dose of study treatment|Patients who received at least one dose of study medication. One of the 12 patients never received study medication so only 11 were evaluable for toxicity||participants|||Number
847402|NCT00582790|Secondary|Number of Participants With Overall Survival and Progression-free Survival at 24 Weeks|All 12 patients were followed for survival until death. 8 participants who received more than one cycle of treatment and who were considered evaluable for response were followed until time to progression. Disease progression was determined by CT scans of the chest/abdomen/pelvis obtained every 2 cycles and based on RECIST version 1.0. Progression is defined using RECIST (V1.0) at least a 20% increase in the sum of the longest diameter (LD)of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions|Time frame is from study entry until time to disease progression and time to death, up to 50 months|8 of the 12 participants who received more than 1 cycle of therapy and were considered evaluable for time to progression. All 12 were evaluated for survival||participants|||Number
847403|NCT00582790|Primary|Number of Subjects With Antitumor Response With Low-dose Interleukin-2 in Combination With Zoledronic Acid|Anti-tumor response was measured per RECIST criteria (V1.0) and assessed by chest/abdomen/pelvis CT: Complete Response (CR), disappearance of all target lessions; Partial Response (PR), >=30% decrease in the sum of the longest diameter (LD) of target lesions; Stable Response (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD since the treatment started.|CT scans obtained at baseline, then every 2 cycles|Anti tumor response was measured in those patients who completed at least 1 cycle of study treatment 4 subjects did not complete 1 cycle of treatment.||participants|||Number
847404|NCT00582010|Primary|Number of Complications Related to Liver Function Recovery Post-transplantation (Total Complications) at 9 Months Post Surgery|Number of any complication reported by subjects at 9 months after surgery|baseline to 9 months post surgery|||complications|||Number
847405|NCT00582010|Primary|Change in Rate of Liver Function Recovery Post-transplantation (Decrease in Hepatobiliary Complications)|Number of complications due to hepatobiliary events.|baseline to 9 months after transplantation|||Complications|||Number
847406|NCT00582010|Secondary|Effect of iNO on SICU Stay|Number of minutes after surgery subject remained in SICU|baseline to discharge for SICU|||minutes||Inter-Quartile Range|Mean
847407|NCT00582010|Primary|Change in Rate of Liver Function Recovery Post-transplantation (Percent Change in Bilirubin Levels)|A positive percent reflects an decrease; a negative percentage reflects a increase.|baseline and 96 hours after baseline|||percent change from baseline||Standard Deviation|Mean
847408|NCT00582010|Primary|Change in Rate of Liver Function Recovery Post-transplantation (Percent Change in Prothrombin Times (PT))|The faster the percent increase of PT reflect, the greater the treatment improved liver function post transplant. A positive percent reflects an decrease; a negative percentage reflects a increase.|baseline and 96 hours after baseline|||percentage change from baseline||Standard Deviation|Mean
847409|NCT00582010|Primary|Change in Rate of Liver Function Recovery Post-transplantation (Percent Change in Alkaline Phosphatase Levels)|The faster the percent increase of alkaline phosphatase reflect, the greater the treatment improved liver function post transplant. A positive percent reflects an increase; a negative percentage reflects a decrease.|baseline and 96 hours after baseline|||percentage change from baseline||Standard Deviation|Mean
847410|NCT00582010|Primary|Changed Rate of Liver Function Recovery Post-transplantation (Percent Change in ALT Levels)|The faster the percent decrease ALT reflect, the greater the treatment improved liver function post transplant. A positive percent reflects an decrease; a negative percentage reflects a increase. . (ALT levels were lower at 96 hours relative to baseline- positive values in data table indicate percent decrease of ALT relative to baseline).|baseline and 96 hours after baseline|||percentage change from baseline||Standard Deviation|Mean
847411|NCT00582010|Secondary|Effect of iNO on Hosptial Length of Stay|number of days subject in hospital after surgery until discharge|from surgery through discharge from hospital|||days||Inter-Quartile Range|Mean
847412|NCT00582010|Primary|Changed Rate of Liver Function Recovery Post-transplantation (Percent Change in AST Levels)|The faster the percent decrease of AST reflect the greater the treatment improved liver function post transplant. A positive percent reflects an decrease; a negative percentage reflects a increase. The rate was calculated by measuring AST levels at baseline and at 96 hours post baseline. (AST levels were lower at 96 hours relative to baseline- positive values in data table indicate percent decrease of AST relative to baseline).|baseline and 96 hours after baseline|||percentage change from baseline||Standard Deviation|Mean
847413|NCT00580606|Secondary|Percent of Participants Who Successfully Consumed 10,000 mg of Peanut Powder|Tolerance Assessment: Participants who successfully consumed without dose-limiting symptoms 10,000 mg of peanut powder during a double-blind placebo-controlled oral food challenge were then given an open feeding of peanut butter and those who successfully consumed the open feeding were counted as successes.|Approximately 8 weeks after discontinuing study therapy after 3 years on maintenance study therapy|All subjects randomized to the Low Dose Peanut SLIT group and all subjects randomized to the Placebo group who crossed over to open label high dose peanut sublingual immunotherapy were included.||percentage of participants|||Number
847414|NCT00580606|Secondary|Number of Crossover Participants With Serious Adverse Events (SAEs) During 44 Weeks of Open Label Peanut Protein Consumption|All subjects who were in the Placebo group during the double-blind phase of the study who initiated crossover peanut sublingual immunotherapy during the open label phase of the study will be included.|Initiation of open label peanut protein study therapy through Week 44 of open label peanut protein consumption|All subjects who were in the Placebo group during the double-blind phase of the study who initiated crossover peanut sublingual immunotherapy during the open label phase of the study will be included.||participants|||Number
847415|NCT00580606|Secondary|Number of Participants With Serious Adverse Events (SAEs)|This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.|Baseline through Week 44 (Double Blind Period)|The intention to treat (ITT) population was used which included all subjects randomized to double-blind treatment.||participants|||Number
847416|NCT00580606|Secondary|Percent of Crossover Participants Who Achieved an Open Label Peanut Protein Consumption Maintenance Dose of 3,696 mcg|During the build-up phase, escalation was to occur every 2 weeks until the 3,696 mcg maintenance dose was reached. The maximum time allowed for the build-up phase was 36 weeks; the dose achieved by 36 weeks was considered the maintenance dose.|Week 44 after initiating crossover open label peanut protein consumption|All subjects in the Placebo group during the double-blind period who crossed over to open label high dose peanut sublingual immunotherapy were included.||Percentage of participants|||Number
847417|NCT00580606|Secondary|Percent of Crossover Participants Who Successfully Consumed 5,000 mg of Peanut Powder or at Least a 10-fold Increase in the Amount of Peanut Powder Compared to Their Baseline Oral Food Challenge After 44 Weeks of Open Label Peanut Protein Consumption|Desensitization Assessment: Participants who successfully consumed without dose-limiting symptoms 5,000 mg of peanut powder or at least a 10-fold increase in the amount of peanut powder compared to their baseline oral food challenge during a double-blind placebo-controlled oral food challenge were counted as successes.|Week 44 after initiating crossover open label peanut protein consumption|Subjects in the Placebo group during the double-blind period who crossed over to open label high dose peanut sublingual immunotherapy were included except for 1 subject who refused the crossover Week 44 OFC and could not be evaluated. 4 subjects who discontinued dosing prior to the crossover Week 44 OFC were counted as failures.||Percentage of participants|||Number
847418|NCT00580606|Secondary|Percent of Participants Who Achieved a Maintenance Dose of 1,386 mcg|During the build-up phase, escalation was to occur every 2 weeks until the 1,386 mcg maintenance dose was reached. The maximum time allowed for the build-up phase was 36 weeks; the dose achieved by 36 weeks was considered the maintenance dose.|Week 44 (Double Blind Period)|The intention to treat (ITT) population was used which included all subjects randomized to double-blind treatment.||Percentage of participants|||Number
847419|NCT00580606|Primary|Percent of Participants Who Successfully Consumed 5,000 mg of Peanut Powder or at Least a 10-fold Increase in the Amount of Peanut Powder Compared to Their Baseline Oral Food Challenge|Desensitization Assessment: Participants who successfully consumed without dose-limiting symptoms 5,000 mg of peanut powder or at least a 10-fold increase in the amount of peanut powder compared to their baseline oral food challenge during a double-blind placebo-controlled oral food challenge were counted as successes.|Week 44 (Double Blind Period)|The intention to treat (ITT) population was used which included all subjects randomized to double-blind treatment.||Percentage of participants|||Number
847420|NCT00578448|Secondary|Mean Change From Baseline to Days 5, 28, 112, 168, and 364 in Kynurenine - All Treated Participants|Indoleamine 2,3 dioxygenase (IDO) is a tryptophan catabolizing enzyme that can be induced in antigen-presenting cells by the engagement of B7 by CTLA-4. Tryptophan depletion in cellular microenvironments has an inhibitory effect on T cells and may be part of a broader immuno-regulatory effect of IDO induction. The IDO activity was determined by measuring the quantity of tryptophan and its metabolite, kynurenine, in serum samples using a validated high performance liquid chromatography (HPLC) method. Baseline is defined as pre-dose. Kynurenine was measured in micromoles (µM).|Day 1 to Day 364|Number analyzed for Baseline, Days 5, 28, 112, 168, 364 = 12, 11, 11, 10, 10, and 10, respectively.||µM||Standard Deviation|Mean
847468|NCT00555321|Secondary|Summary Statistics for Lipid Parameters; Serum HDL Cholesterol: 12-month Treatment Phase||Baseline (pretransplant), 1, 6, 12 months posttransplant|ITT population, all randomized and transplanted participants. n = participants who had both baseline and postbaseline values.||mg/dL||Standard Deviation|Mean
848719|NCT00602836|Secondary|Number of Participants Who Convert From a CR With MRD or nPR, PR, or Stable Disease With Residual Disease After PCR to a CR With MRD-negative Status After 6 Courses of Consolidation With Lenalidomide||12 months||||||
847421|NCT00578448|Secondary|Mean Change From Baseline to Days 5, 28, 112, 168, and 364 in Tryptophan - All Treated Participants|Indoleamine 2,3 dioxygenase (IDO) is a tryptophan catabolizing enzyme that can be induced in antigen-presenting cells by the engagement of B7 by cytotoxic lymphocyte antigen 4 (CTLA-4). Tryptophan depletion in cellular microenvironments has an inhibitory effect on T cells and may be part of a broader immuno-regulatory effect of IDO induction. The IDO activity was determined by measuring the quantity of tryptophan and its metabolite, kynurenine, in serum samples using a validated high performance liquid chromatography (HPLC) method. Baseline is defined as pre-dose. Tryptophan was measured in micromoles (µM)|Baseline to Day 364|Number analyzed for Baseline, Days 5, 28, 112, 168, 364 = 12, 11, 11, 10, 10, and 10, respectively.||µM||Standard Deviation|Mean
847422|NCT00578448|Secondary|Acute Rejection, Graft Loss, and Death up to 3 Years Post Transplantation in Planned Study and 1 Year Long Term Extension - All Treated Participants|Acute rejection of transplant defined as a clinicopathological event requiring clinical evidence and biopsy confirmation by central pathologist. Graft loss was defined as either functional loss or physical loss. Day 1 is day of transplantation.|Day 1 up to 4 years post transplantation|All treated participants were analyzed during the planned 3 year study N=12. Only 9 participants entered the LTE so N=9 for LTE.||participants|||Number
847423|NCT00578448|Primary|Serum Half Life (T-HALF) Between Weeks 12 and 16 Following 10mg/kg IV Belatacept - Pharmacokinetic Population|At Day 84, blood samples obtained from pre-dose (0 hour) and ended at 672 hour (h) on Day 112. The samples were analyzed for belatacept by enzyme-linked immunosorbent assay (ELISA) using a validated method. Individual participant PK parameters were derived from serum concentration versus time data using a non-compartmental method, using a validated PK analysis program (KineticaTM 4.4.1 within the eToolbox [version 2.6.1]). Actual sampling times were used for PK calculations. T-HALF was calculated as ln2/Lz, where Lz is the absolute value of the slope of the terminal log-linear phase. T-HALF is measured in hours (h).|Day 84 to Day 112|||hours||Standard Deviation|Mean
847424|NCT00578448|Primary|Steady-state Volume Distribution (Vss) Following 10mg/kg IV Belatacept Between Weeks 12 and 16 - Pharmacokinetic Population|At Day 84, blood samples obtained from pre-dose (0 hour) and ended at 672 hour (h) on Day 112. The samples were analyzed for belatacept by enzyme-linked immunosorbent assay (ELISA) using a validated method. Individual participant PK parameters were derived from serum concentration versus time data using a non-compartmental method, using a validated PK analysis program (KineticaTM 4.4.1 within the eToolbox [version 2.6.1]). Actual sampling times were used for PK calculations. Vss was calculated by dividing the dose by AUC and multiply the mean residence time (MRT). Vss was adjusted to body weight and measured as liter per kilogram body weight (l/kg).|Day 84 to Day 112|||l/kg||Standard Deviation|Mean
847425|NCT00578448|Primary|Total Body Clearance (CLT) Between Weeks 12 and 16 Following 10mg/kg IV Belatacept - Pharmacokinetic Population|At Day 84, blood samples obtained from pre-dose (0 hour) and ended at 672 hour (h) on Day 112. The samples were analyzed for belatacept by enzyme-linked immunosorbent assay (ELISA) using a validated method. Individual participant PK parameters were derived from serum concentration versus time data using a non-compartmental method, using a validated PK analysis program (KineticaTM 4.4.1 within the eToolbox [version 2.6.1]). Actual sampling times were used for PK calculations. CLT was calculated by dividing the dose by AUC(TAU) and was adjusted to body weight. CLT was measured as milliliter per time per kg body weight (mL/h/kg).|Day 84 to Day 112|Participants who were treated and had PK data.||mL/h/kg||Geometric Coefficient of Variation|Geometric Mean
847426|NCT00578448|Secondary|Summary of Trough Serum Concentration of Belatacept Prior to Dosing up to 3 Years Post Transplantation - Pharmacokinetic Population|Blood samples were obtained pre and post dose at designated time points up to Day 112 and thereafter, pre-dose samples were obtained at Days 168 and 364, and then once yearly up to end of Year 3. The samples were analyzed for belatacept by enzyme-linked immunosorbent assay (ELISA) using a validated method. Individual participant PK parameters were derived from serum concentration versus time data using a non-compartmental method, using a validated PK analysis program (KineticaTM 4.4.1 within the eToolbox [version 2.6.1]). Actual sampling times were used for PK calculations. The trough serum concentration (Cmin), was recorded directly from experimental observations. Using no weighting factor, the terminal log-linear phase of the concentration-time curve was identified by least-square linear regression of at least 3 data points that yielded a maximum G-criteria, which is also referred to as adjusted R-squared. Cmin was measured as micrograms per milliliter (µg/mL).|Day 1 to Day 1092|Number of participants (N) analyzed = 11 for Days 5, 14,and 28; and 12 for Day 56. Days 84, 112, 168, 364 N=10.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
847427|NCT00578448|Primary|Area Under the Concentration Time Curve Within a Dosing Interval (AUC) (TAU) Between Weeks 12 and 16 Following 10 mg/kg IV Belatacept - Pharmacokinetic Population|At Day 84, blood samples obtained from pre-dose (0 hour) and ended at 672 hour (h) on Day 112. The samples were analyzed for belatacept by enzyme-linked immunosorbent assay (ELISA) using a validated method. Individual participant PK parameters were derived from serum concentration versus time data using a non-compartmental method, using a validated PK analysis program (KineticaTM 4.4.1 within the eToolbox [version 2.6.1]). The area under the concentration-time curve in one dose interval [AUC(TAU), where TAU = 4 weeks] were calculated using the mixed log-linear trapezoidal algorithm in Kinetica. Actual sampling times were used for PK calculations. AUC (TAU) was measured as micrograms multiplied by time(h) per milliliter (µg*h/mL).|Day 82 to Day 112|||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
847428|NCT00578448|Primary|Time of Maximum Observed Serum Concentration (Tmax) Between Weeks 12 and 16 Following 10mg/kg IV Belatacept - Pharmacokinetic Population|Tmax measured in hours (h). At Day 84, blood samples obtained from pre-dose (0 hour) and ended at 672 (h) on Day 112 . The samples were analyzed for belatacept by enzyme-linked immunosorbent assay (ELISA) using a validated method. Individual participant PK parameters were derived from serum concentration versus time data using a non-compartmental method, using a validated PK analysis program (KineticaTM 4.4.1 within the eToolbox [version 2.6.1]). Actual sampling times were used for PK calculations.|Day 84 to Day 112|1 participant excluded from analysis of Cmax and Tmax due to a very high concentration value (it was considered an outlier) therefore, for Tmax, Number of participants analyzed (N)=9.||hours||Full Range|Median
847469|NCT00555321|Secondary|Summary Statistics for Lipid Parameters-Serum Total Non-High Density Lipoprotein (Non-HDL) Cholesterol: 12-month Treatment Phase||Baseline (pretransplant), 1, 6, 12 months posttransplant|ITT population, all randomized and transplanted participants. n = participants who had both baseline and postbaseline values.||mg/dL||Standard Deviation|Mean
847429|NCT00578448|Primary|Maximum Observed Serum Concentration (Cmax) Between Weeks 12 and 16 Following 10mg/kg IV Belatacept and Trough Serum Concentration Prior to Dosing (Cmin) - Pharmacokinetic Population|Cmax, Cmin are measured in micrograms per milliliter (µg/mL). At Day 84, blood samples obtained from pre-dose (0 hour) and ended at 672 hour (h) on Day 112. Serum samples were analyzed for belatacept by enzyme-linked immunosorbent assay (ELISA) using a validated method. Individual participant PK parameters were derived from serum concentration versus time data using a non-compartmental method, using a validated PK analysis program (KineticaTM 4.4.1 within the eToolbox [version 2.6.1]). Actual sampling times were used for PK calculations. The Cmax, and the Cmin were recorded directly from experimental observations. Using no weighting factor, the terminal log-linear phase of the concentration-time curve was identified by least-square linear regression of at least 3 data points that yielded a maximum G-criteria, which is also referred to as adjusted R-squared. Values below lower limits of quantification (LLQ), 0.003 µg/mL, were set to 0.0015 for computation of summary statistics.|Day 84 to Day 112|One participant excluded from analysis of Cmax and Tmax due to a very high concentration value (it was considered an outlier) therefore, for Cmax, Number of participants analyzed (N)=9.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
847430|NCT00578448|Primary|Mean Belatacept Serum Concentrations Between Weeks 12 and 16 by Nominal Collection Time, Following 10mg/kg IV Belatacept - Pharmacokinetic Population|Pharmacokinetic (PK) sampling started from pre-dose (0 hour) on Day 84 and ended at 672 hour (h) on Day 112 (between Weeks 12 to 16). The samples were analyzed for belatacept by enzyme-linked immunosorbent assay (ELISA) using a validated method and measured as nanograms/milliliter (ng/mL). Less than the lower limit of quantification (LLQ), 3.000 ng/mL concentration value was treated as missing.|Day 84 to Day 112|Number (N) of participants analyzed for each collection time was 10, except for time 0.50 h, which was missing 1 participant. Therefore Number (N) for Time 0.50 h = 9.||ng/mL||Standard Deviation|Mean
847431|NCT00556374|Secondary|Overall Survival|Overall survival (OS) determined by the time from randomization to death from any cause. OS will be analyzed after long-term follow-up is complete.|Participants will be followed for overall survival once every 12 months for 66 months after primary completion date.||10/2020||||
847432|NCT00556374|Secondary|Bone Metastases-free Survival|Bone metastasis-free survival (BMFS) determined by the time from randomization to the first observation of bone metastasis or death from any cause. BMFS will be analyzed after long-term follow-up is complete.|Participants will be followed for bone metastasis-free survival once every 12 months for 66 months after primary completion date.||10/2020||||
847433|NCT00556374|Secondary|Disease-free Survival|Disease-free survival (DFS) determined by the time from randomization to the first observation of disease recurrence or death from any cause. DFS will be analyzed after long-term follow-up is complete.|Participants will be followed for disease-free survival (DFS) once every 12 months for 66 months after primary completion date.||10/2020||||
847434|NCT00556374|Secondary|Number of Participants With New or Worsening Vertebral Fractures|Assessment of vertebral fractures was performed by an expert radiologist at the central imaging center using a semiquantitative grading scale: Grade 1, 20% to 25% reduction in vertebral height (anterior, middle, or posterior); Grade 2, 25% to 40% reduction in height; Grade 3, greater than 40% reduction in height. A new vertebral fracture is defined as a fracture in a previously undeformed vertebrae including new compression fractures, defined as those compression fractures having a decrease in total anterior or posterior height of at least 25% from baseline. New vertebral fractures includes morphometric vertebral fractures identified from on study x-rays and clinical vertebral fractures confirmed by x-rays. Worsening of pre-existing fractures is defined as an increase in fracture severity of at least 1 grade on the semiquantitative scale.|36 months|Vertebral Fracture Analysis Set with a Baseline and at least one post-baseline vertebral x-ray prior to or at Month 36.||participants|||Number
847435|NCT00556374|Secondary|Number of Participants With New Vertebral Fractures|"Assessment of vertebral fractures was performed by an expert radiologist at the central imaging center using a semiquantitative grading scale: Grade 1, 20% to 25% reduction in vertebral height (anterior, middle, or posterior); Grade 2, 25% to 40% reduction in height; Grade 3, greater than 40% reduction in height.
A new vertebral fracture is defined as a fracture in a previously undeformed vertebrae including new compression fractures, defined as those compression fractures having a decrease in total anterior or posterior height of at least 25% from baseline. New vertebral fractures includes morphometric vertebral fractures identified from on study x-rays and clinical vertebral fractures confirmed by x-rays."|36 months|Vertebral Fracture Analysis Set with a Baseline and at least one post-baseline vertebral x-ray prior to or at Month 36.||participants|||Number
847436|NCT00556374|Secondary|Percent Change From Baseline in Femoral Neck BMD at Month 36 at Pre-selected Sites|Bone mineral density was assessed by dual x-ray absorptiometry.|Baseline and Month 36|BMD analysis set - femoral neck at Month 36 (participants with evaluable BMD values at Baseline and Month 36 for femoral neck)||percent change||95% Confidence Interval|Least Squares Mean
847437|NCT00556374|Secondary|Percent Change From Baseline in Total Hip BMD at Month 36 at Pre-selected Sites|Bone mineral density was assessed by dual x-ray absorptiometry.|Baseline and Month 36|BMD analysis set - total hip at Month 36 (participants with evaluable BMD values at Baseline and Month 36 for total hip)||percent change||95% Confidence Interval|Least Squares Mean
847438|NCT00556374|Secondary|Percent Change From Baseline in Total Lumbar Spine Bone Mineral Density (BMD) at Month 36 at Pre-selected Sites|Bone mineral density was assessed by dual x-ray absorptiometry.|Baseline and Month 36|BMD analysis set - total lumbar spine at Month 36 (participants with evaluable BMD values at Baseline and Month 36 for total lumbar spine)||percent change||95% Confidence Interval|Least Squares Mean
847439|NCT00556374|Primary|Time to First Clinical Fracture|The time to first on-study clinical fracture defined as the number of days from randomization to the date of the x-ray confirming the clinical fracture. A clinical fracture is any clinically evident fracture with associated symptoms and confirmed by x-ray. Participants who died or withdrew without experiencing a clinical fracture were censored at the date of last contact or study termination whichever was earlier.|From randomization until the primary analysis cut-off date of 26 March 2014; maximum time on study was 87 months.|Full analysis set (all randomized participants)||days||95% Confidence Interval|Median
847543|NCT00550459|Secondary|Number of Patients With Serum Chemistry Laboratory Abnormalities: Uric Acid|Incidence of potentially clinically significant uric acid levels post-baseline (normal range=4-8.5 mg/dL)|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication||participants|||Number
847440|NCT00555893|Secondary|Mean Influenza Well-being Score (Health, Ability to Perform Usual Activities and Sleep Quality)|Mean influenza wellbeing score will be calculated by first summing the daily scores for overall health (0-9 points), ability to perform usual activities (0-9 points), and sleep quality (0-9 points) from initial enrollment (randomization) up to (and including) the first day of symptom resolution. This will be divided by the number of reporting days to yield the mean daily influenza wellbeing score for each person.|Interval from randomization up to and including first day of symptom resolution (minimum 7 days, maximum 14 days)||||||
847441|NCT00555893|Secondary|Secondary Complications (New Clinical Diagnosis of Acute Otitis Media, Acute Sinusitis or Radiographically Confirmed Pneumonia)Documented in Medical Record, or Influenza-related Hospital Admission|Episodes of pneumonia will require a physician diagnosis of pneumonia, antimicrobial treatment for pneumonia, and an opacity or infiltrate on chest radiograph (or CT) that was not known to be chronic.|From 0 to 30 days after randomization||||||
847442|NCT00555893|Secondary|Duration of Viral Shedding||Interval (in days) from collection of the first sample yielding a positive influenza test to the last sample yielding a positive culture (maximum 14 days)||||||
847443|NCT00555893|Secondary|Mean Illness Severity Score|Mean severity score will be calculated by first summing the symptom severity scores for all reporting periods from initial enrollment (randomization) up to (and including) the first period of symptom resolution, as defined above. The summed total will be divided by the number of reporting periods to yield the mean severity score for each participant. For each reporting period, the possible symptom scores will range from 0 (all symptoms absent) to 24 (all symptoms severe). For children less than 2 years old, the possible scores will range from 0 to 15.|Calculated from initial enrollment (randomization) up to first period of symptom resolution (minimum of 7 days, maximum of 14 days)|All participants over 24 months of age (n=5 were excluded because <24 months)||mean severity score||Inter-Quartile Range|Median
847444|NCT00555893|Primary|Duration of Influenza Illness|Resolution is defined as occurring at the start of the first 24-hour period in which the total symptom score was less than or equal to 2 with no symptom rated higher than mild. Time to resolution was calculated from the time of randomization to symptom resolution in 12 hour increments.|Interval (in 12 hour blocks) from time of randomization until resolution (minimum 7 days, maximum 14 days)|||days||95% Confidence Interval|Median
847445|NCT00555321|Secondary|Change in Protein to Creatinine Ratio From Month 3 to Month 12.||Month 3 and 12|Protein creatinine ratio change was not analyzed|||||
847446|NCT00555321|Secondary|Number of Participants Who Had Abnormalities in Electrocardiograms: 12-month Treatment Phase||Baseline (pretransplant), Week 52|ECG data was not analyzed.|||||
847447|NCT00555321|Secondary|Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities: 12-month Treatment Phase|Low total calcium: <7 mg/dL; High total calcium: >12.5 mg/dL ; Low bicarbonate: <11 mEq/L; Low serum potassium: <3.0 mEq/L; High serum potassium:>6.0 mEq/L; High serum magnesium: >2.46 mEq/L; Low serum magnesium:<0.8 mEq/L; Low serum sodium: <130 mEq/L; High serum sodium: >155 mEq/L; Low inorganic phosphorus: <2.0 mg/dL; Low albumin: <2 g/dL; High uric acid: >10 mg/dL|Baseline (pretransplant), Weeks 4, 12, 24, and 52|ITT population, all randomized and transplanted participants. n= participants with all observations.||participants|||Number
847448|NCT00555321|Secondary|Number of Participants With Marked Liver and Kidney Function Abnormalities: 12-month Treatment Phase|ULN= upper limit of normal; Normal ranges are provided by the central laboratory and may vary according to sex and age. High alkaline phosphatase (ALP): >5.0*ULN U/L; High alanine aminotransferase (ALT): >5.0*ULN U/L; High aspartate aminotransferase (AST): >5.0*ULN U/L; High direct bilirubin: >3.0 * ULN mg/dL; High g-glutamyl transferase (GGT): >5.0*ULN U/L; High total bilirubin: >3.0*ULN mg/dL; High creatinine: > 3.0*ULN mg/dL|Baseline (pretransplant), 4, 12, 24, 52 weeks|ITT population, all randomized and transplanted participants. n= participants with all observations.||participants|||Number
847449|NCT00555321|Secondary|Number of Participants With Marked Hematology Abnormalities: 12-month Treatment Phase|Low hemoglobin: <8 g/dL; Low platelet count: <50*10^9 C/L; Low leukocytes: <2.0 *10^3 c/µL; Low lymphocytes (absolute): <0.5*10^3 c/µL; Low neutrophils (absolute): <1.0*10^3 Cc/µL.|Baseline (pretransplant), 2, 4, 8, 12 weeks, and every 4 weeks for week 16 to 52|ITT population, all randomized and transplanted participants. n= participants with all observations.||participants|||Number
847450|NCT00555321|Secondary|Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase|AE of of special interest included malignancies (including skin carcinomas), infections (viral, cytomegalovirus, herpes, fungal, and bacterial), serious infections|Day 1 (randomization) to 12 months or ≤ 56 days after discontinuation of study medication|ITT population, all randomized and transplanted participants.||participants|||Number
847451|NCT00555321|Secondary|Number of Participants Who Had AEs, Death, SAEs or Were Discontinued Due to AEs: 12-month Treatment Phase|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant administered an investigational product and that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event|Day 1 (randomization) to 12 m + 8 week follow-up or ≤ 56 days after discontinuation of study medication|ITT population: all randomized and transplanted participants||participants|||Number
847452|NCT00555321|Secondary|Glycosylated Hemoglobin (HbA1C) Values: 12-month Treatment Phase|The HbA1c test is important in diabetes as a long-term measure of control over blood glucose, where the glucose bound to hemoglobin during the past 3-4 months is measured. A baseline diabetes participant was one who had a medical history of diabetes or being under anti-diabetic medication at the time of the transplantation. BL = baseline, DM = Diabetes mellitus.|6, 12 months (mth) posttransplant|ITT population, all randomized and transplanted participants. n = Participants with both baseline and postbaseline values.||Percentage of glycosylated hemoglobin||Standard Deviation|Mean
847481|NCT00555321|Secondary|Belatacept PK Parameter: Terminal Half-life|Terminal Half-life (T 1/2) is the time a drug takes for the concentration levels to fall to 50% of their value.|Samples were collected at Pre dose on Days 5, 14, 28, 56, 84, 112, 168, 252, 336, 364; after end of infusion on Days 1, 5, 84, 112, 196, 336; and on Days 9, 85, 91, 98, 105.|All randomized participants who received belatacept, and had complete PK profile.||hour||Standard Deviation|Mean
847453|NCT00555321|Secondary|Percentage of Participants With New Onset Diabetes Mellitus (NODM): 12-month Treatment Phase|A participant who did not have diabetes prior to randomization was determined to have NODM if(i) the participant received an antidiabetic medication for a duration of at least 30 days or(ii) at least two fasting plasma glucose (FPG) tests indicate that FPG is>=126 mg/dL (7.0 mmol/L). For 95% CI within each group, normal approximation is used if N>=5. For 95% CI of difference, adjustment is made for randomization strata (HCV-Infection status at baseline) if N >= 5 in each treatment arm.|6 and 12 months posttransplant|ITT population, all randomized participants without Diabetes Mellitus (pre-transplantation).||percentage of participants||95% Confidence Interval|Number
847454|NCT00555321|Secondary|Number of Participants Who Received Anti-hypertensive Therapy at Month 12||12 months posttransplant|ITT population, all randomized and transplanted participants.||participants|||Number
847455|NCT00555321|Primary|Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities During the LTE|Low Serum Potassium: <3.0 meq/L; High serum potassium:>6.0 mEq/L; Low serum magnesium:<0.8 mEq/L; Low serum sodium: <130 mEq/L; High serum sodium: >155 mEq/L; Low inorganic phosphorus: <2.0 mg/dL; High uric acid: >10 mg/dL|Every 4 weeks from Week 53 to Week 104.|ITT-LTE population: All randomized and transplanted participants who entered long-term extension. n= participants who had a laboratory test reading after transplant for the specific analyte.||participants|||Number
847456|NCT00555321|Primary|Number of Participants With Marked Liver and Kidney Function Abnormalities During the LTE|ULN= upper limit of normal; Normal ranges are provided by the Central Laboratory and may vary according to sex and age. High alanine aminotransferase (ALT): >5.0*ULN U/L; High aspartate aminotransferase (AST): >5.0*ULN U/L; High direct bilirubin: >3.0*ULN mg/dL; High g-glutamyl transferase (GGT): >5.0*ULN U/L; High total bilirubin: >3.0*ULN mg/dL; High creatinine: > 3.0*ULN mg/dL|Every 4 weeks from Week 53 to Week 104.|ITT-LTE population: All randomized and transplanted participants who entered long-term extension. n= participants who had a laboratory test reading after transplant for the specific analyte.||participants|||Number
847457|NCT00555321|Primary|Number of Participants With Marked Hematology Abnormalities During the LTE|Low platelet count: <50*10^9 c/µl; Low leukocytes: <2.0*10^3 c/µl; Low lymphocytes (absolute): <0.5*10^3 c/µl; Low neutrophils (absolute): <1.0*10^3 c/µl.|Every 4 weeks from Week 53 to Week 104.|ITT-LTE population: All randomized and transplanted participants who entered long-term extension. n= participants who had a laboratory test reading after transplant for the specific analyte.||participants|||Number
847458|NCT00555321|Primary|Number of Participants Who Had AEs of Special Interest During the LTE|AE of special interest included malignancies (including skin carcinomas), infections (viral, cytomegalovirus, herpes, fungal, and bacterial).|Day 1 (randomization) through database lock (20-June-2011)|ITT-LTE population, all randomized and transplanted participants who entered long term extension||participants|||Number
847459|NCT00555321|Primary|Number of Participants Who Had Adverse Events (AEs), Death, Serious AEs (SAEs) or Were Discontinued Due to AEs (Includes Long Term Extension [LTE] Data)|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.|Day 1 (randomization) to Week 104 + within 56 Days after the last infusion/dose, Deaths were monitored up to database lock (20-June-2011)|ITT-LTE population, (all randomized and transplanted participants who entered long term extension). Participants were grouped according to the treatment to which they were randomized initially.||participants|||Number
847460|NCT00555321|Secondary|Percentage of Participants Who Have Hypertension at Any Given Time During the 12-month Treatment Phase|Percentage of participants at any given time who meet the definition of hypertension. Participants were considered to have hypertension when either of the following criteria were met: (1) SBP ≥ 130 mm Hg or DBP ≥ 80 mm Hg or (2) participant received an antihypertensive medication(s) for the indication of hypertension or due to medical history of hypertension.|6 and 12 months posttransplant|ITT population, all randomized and transplanted participants.||percentage of participants||95% Confidence Interval|Number
847461|NCT00555321|Secondary|Percentage of Participants Who Developed Hypertension in 12-month Treatment Phase|Percentage of participants who develop hypertension after randomization and transplantation. Transient post-operative increases in BP were not to be counted as new onset hypertension. Hypertension was to be assessed only at or after the Week 4 visit. Participants were considered to have hypertension when either of the following criteria were met: (1) SBP ≥ 130 mm Hg or DBP ≥ 80 mm Hg or (2) participant received an antihypertensive medication(s) for the indication of hypertension or due to medical history of hypertension.|6 and 12 months posttransplant|ITT population, all randomized and transplanted participants.||percentage of participants||95% Confidence Interval|Number
847462|NCT00555321|Secondary|Summary Statistics for Mean Arterial Pressure: 12-month Treatment Phase||BL (pretransplant), 1, 3, 6, 9, 12 months posttransplant|ITT population, all randomized and transplanted participants. n = participants who had both baseline and postbaseline values.||mm Hg||Standard Deviation|Mean
847463|NCT00555321|Secondary|Summary Statistics for Diastolic Blood Pressure: 12-month Treatment Phase|Participants were considered to have hypertension if they had Diastolic Blood Pressure (SBP) ≥ 80 mmHg.|BL (pretransplant), 1, 3, 6, 9, 12 months posttransplant|ITT population, all randomized and transplanted participants. n = participants who had both baseline and postbaseline values.||mm Hg||Standard Deviation|Mean
847464|NCT00555321|Secondary|Summary Statistics for Systolic Blood Pressure: 12-month Treatment Phase||Baseline (pretransplant), 1, 3, 6, 9, 12 months posttransplant|ITT population, all randomized and transplanted participants. n = participants who had both baseline and postbaseline values.||mm Hg||Standard Deviation|Mean
847465|NCT00555321|Secondary|Summary Statistics for Lipid Parameters - Serum Triglyceride: 12-month Treatment Phase||Baseline (pretransplant), 1, 6, 12 months posttransplant|ITT population, all randomized and transplanted participants. n = participants who had both baseline and postbaseline values.||mg/dL||Standard Deviation|Mean
847466|NCT00555321|Secondary|Summary Statistics for Lipid Parameters- Serum Cholesterol: 12-month Treatment Phase||Baseline (pretransplant), 1, 6, 12 months posttransplant|ITT population, all randomized and transplanted participants.||mg/dL||Standard Deviation|Mean
847470|NCT00555321|Secondary|Percentage of Participants Meeting the Definition of Dyslipidemia, Hypertriglyceridemia or Hypercholesterolemia at Any Given Time: 12-month Treatment Phase|Percentage of participants at any given time (at Month 6 and Month 12) who met the definition of dyslipidemia.Dyslipidemia is defined as hypertriglyceridemia (TGs ≥ 500 mg/dL [5.65 mmol/L]), hypercholesterolemia (LDL ≥ 100 mg/dL [2.59 mmol/L]), or elevated non-HDL (non-HDL ≥ 130 mg/dL [3.36 mmol/L]) in the presence of high TGs (TGs ≥ 200 mg/dL [2.26 mmol/L]).|6 and 12 months posttransplant|ITT population, all randomized and transplanted participants.||percentage of participants||95% Confidence Interval|Number
847471|NCT00555321|Secondary|Percentage of Participants Who Develop Dyslipidemia, Hypertriglyceridemia and Hypercholesterolemia After Randomization and Transplantation: 12-month Treatment Phase|Percentage of participants who develop dyslipidemia, defined as hypertriglyceridemia (triglycerides [TGs] ≥ 500 mg/dL [5.65 mmol/L]), hypercholesterolemia (Low density lipoprotein [LDL] ≥ 100 mg/dL [2.59 mmol/L]), or elevated non-high density lipoprotein (non- high density lipoprotein [HDL] ≥ 130 mg/dL [3.36 mmol/L]) in the presence of high TGs (TGs ≥ 200 mg/dL [2.26 mmol/L]).|6 and 12 months posttransplant|ITT population, all randomized and transplanted participants who did not have dyslipidemia at baseline||percentage of participants||95% Confidence Interval|Number
847472|NCT00555321|Secondary|Number of Participants (Who Were HCV Positive at Baseline) With HCV RNA Levels >2.4 * 10^6 U/mL and >4.7 * 10^6 U/mL During the LTE|Recurrent hepatitis C infection of the allograft following liver transplantation can be detected by monitoring HCV RNA levels. In HCV positive participants, quantitative HCV RNA levels > 2.4 x 10^6 U/mL and > 4.7 x 10^6 U/mL were descriptively summarized by treatment group. BL = baseline|BL (pretransplant), 12, 18, 24, 30 months (mo) posttransplant|ITT-LTE population, all randomized and transplanted participants. n= participants with HCV RNA values.||participants|||Number
847473|NCT00555321|Secondary|Number of Participants (Who Were HCV Positive at Baseline) With HCV Ribonucleic Acid (RNA) Levels >2.4*10^6 U/mL and >4.7*10^6 U/mL: 12-month Treatment Phase|Recurrent hepatitis C infection of the allograft following liver transplantation can be detected by monitoring HCV RNA levels. In HCV positive participants, quantitative HCV RNA levels > 2.4 * 10^6 U/mL and > 4.7 * 10^6 U/mL were descriptively summarized by treatment group. BL=baseline|Baseline (pretransplant), 6 and 12 months (mo) posttransplant|ITT population, all randomized and transplanted participants. n= participants who were HCV positive at baseline.||participants|||Number
847474|NCT00555321|Secondary|Percentage of Participants (Who Were Hepatitis C Virus [HCV] Positive at Baseline) With HCV Recurrence (Assessed by Central Pathologist) During the LTE|HCV Recurrence is defined as Histological confirmation on liver biopsy by the Ishak (modified Knodell) system and required both a score >= 5 out of 18 on modified Histological Activity Index grading and a fibrosis Score >= 2 out of 6 on modified staging. All biopsies, including Week 52 biopsies, were considered. Only the first HCV recurrence episode for each participant was counted. For 95% CI within each group, normal approximation was used if N>=5, otherwise exact method was used. For 95% CI of difference, normal approximation was used if N>=5 in both arms, otherwise exact method was used.|12 months posttransplant, end of study (database lock, 20-June-2011)|ITT-LTE population, all randomized and transplanted participants who entered long-term extension.||percentage of participants||95% Confidence Interval|Number
847475|NCT00555321|Secondary|Percentage of Participants (Who Were Hepatitis C Virus [HCV] Positive at Baseline) With HCV Recurrence (Assessed by Central Pathologist) by 12 Months|HCV Recurrence is defined as Histological confirmation on liver biopsy by the Ishak (modified Knodell) system and required both a score >= 5 out of 18 on modified Histological Activity Index grading and a fibrosis Score >= 2 out of 6 on modified staging. All biopsies, including Week 52 biopsies, were considered. Only the first HCV recurrence episode for each participant was counted. For 95% CI within each group, normal approximation was used if N>=5, otherwise exact method was used. For 95% CI of difference, normal approximation was used if N>=5 in both arms, otherwise exact method was used.|6 and 12 months posttransplant|ITT population, all randomized and transplanted participants.||percentage of participants||95% Confidence Interval|Number
847476|NCT00555321|Secondary|Belatacept Trough Concentration Before Each Infusion During the LTE|Minimum Plasma Concentration (Cmin) is the minimum observed serum drug concentration.|Samples were collected predose on Days 5, 14, 28, 56, 84, 112, 168, 252, 336, 364; after end of infusion on Days 1, 5, 84, 112, 196, 336; and on Days 9, 85, 91, 98, 105, 532, 728.|All randomized participants who received Belatacept, and had complete PK profile. n= participants with values at all time points.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
847477|NCT00555321|Secondary|Belatacept PK Parameter: Clearance From Ascites Fluid|Clearance from ascites fluid was determined by amount excreted in ascites fluid (Ae, asc)[0-T] / AUC[0-T], where 0-T is the same duration relative to a belatacept infusion.|Days 1 to 14|Serum AUC was not available for the time interval corresponding to ascites fluid collection.|||||
847478|NCT00555321|Secondary|Belatacept PK Parameter: Amount Excreted in Ascites Fluid Over Days 1 to 14|Amount Excreted in Ascites (Ae,asc) was estimated from the ascites drug concentrations and volumes within a dosing interval.|Days 1 to 14|All randomized participants who received belatacept, and had complete PK profile.||µg||Standard Deviation|Mean
847479|NCT00555321|Secondary|Belatacept PK Parameter: Volume of Distribution|Volume of distribution (Vss) is the volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration. . Vss was estimated from AUC (TAU) between Weeks 12 and 16, assuming steady state.|Samples were collected at Pre dose on Days 5, 14, 28, 56, 84, 112, 168, 252, 336, 364; after end of infusion on Days 1, 5, 84, 112, 196, 336; and on Days 9, 85, 91, 98, 105.|All randomized participants who received belatacept, and had complete PK profile.||L/kg||Standard Deviation|Mean
847480|NCT00555321|Secondary|Belatacept PK Parameter: Total Body Clearance|Total body clearance is the rate and extent at which the drug is eliminated from the body. The clearance of a drug is used to understand the processes involved in drug elimination, distribution and metabolism. CLT was estimated from AUC (TAU) between Weeks 12 and 16, assuming steady state.|Samples were collected at Pre dose on Days 5, 14, 28, 56, 84, 112, 168, 252, 336, 364; after end of infusion on Days 1, 5, 84, 112, 196, 336; and on Days 9, 85, 91, 98, 105.|All randomized participants who received belatacept, and had complete PK profile.||mL/h/kg||Geometric Coefficient of Variation|Geometric Mean
847544|NCT00550459|Secondary|Number of Patients With Serum Chemistry Laboratory Abnormalities: Blood Urea Nitrogen (BUN)|Incidence of potentially clinically significant BUN levels post-baseline (normal range=7-30 mg/dL)|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication||participants|||Number
847482|NCT00555321|Secondary|Belatacept PK Parameter: Minimum Plasma Concentration|Minimum Plasma Concentration (Cmin) is the minimum observed serum drug concentration.|Samples were collected at Pre dose on Days 5, 14, 28, 56, 84, 112, 168, 252, 336, 364; after end of infusion on Days 1, 5, 84, 112, 196, 336; and on Days 9, 85, 91, 98, 105.|All randomized participants who received belatacept, and had complete PK profile.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
847483|NCT00555321|Secondary|Belatacept PK Parameter: Area Under the Serum Concentration-time Curve to the End of the Dosing Period (AUCtau)|Area under the plasma concentration-time curve for each dosing interval is determined using the linear trapezoidal rule. The AUC(TAU) of belatacept from the MI regimens and LI regimens were calculated over 2 and 4 weeks respectively.|Samples were collected at Pre dose on Days 5, 14, 28, 56, 84, 112, 168, 252, 336, 364; after end of infusion on Days 1, 5, 84, 112, 196, 336; and on Days 9, 85, 91, 98, 105.|All randomized participants who received belatacept, and had complete PK profile.||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
847484|NCT00555321|Secondary|Belatacept Pharmacokinetic (PK) Parameter: Time to Achieve the Maximum Plasma Concentration|Maximum Plasma Concentration (Tmax) is the time taken to reach the maximum observed plasma concentration.|Samples were collected at Pre dose on Days 5, 14, 28, 56, 84, 112, 168, 252, 336, 364; after end of infusion on Days 1, 5, 84, 112, 196, 336; and on Days 9, 85, 91, 98, 105.|All randomized participants who received belatacept, and had complete PK profile.||hour||Full Range|Median
847485|NCT00555321|Secondary|Belatacept Pharmacokinetic (PK) Parameter: Maximum Serum Concentration|Maximum Plasma Concentration (Cmax) is the maximum observed serum drug concentration.|Samples were collected at Pre dose on Days 5, 14, 28, 56, 84, 112, 168, 252, 336, 364; after end of infusion on Days 1, 5, 84, 112, 196, 336; and on Days 9, 85, 91, 98, 105.|All randomized participants who received belatacept, and had complete PK profile.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
847486|NCT00555321|Secondary|Mean Change in Baseline Values of Cystatin C at 2 and 12 Months|Cystatin C is a protein encoded by the CST3 gene, which is mainly used as a biomarker of kidney function. If kidney function and glomerular filtration rate decline, the blood levels of cystatin C rise.|Baseline (pretransplant), 2, and 12 months posttransplant|ITT population: all randomized and transplanted participants. n = participants who had both baseline and postbaseline values.||mg/L||Standard Deviation|Mean
847487|NCT00555321|Secondary|Mean Change From Baseline Serum Creatinine at Months 1, 2, 3, 6 and 12|Measurement of SCr is commonly used as an indicator of renal function. High creatinine blood level is an indicator of deficient filtering by the kidney. SCr was determined at baseline and various post-baseline time points.|Baseline (pretransplant time point), 1, 2, 3, 6 and 12 months posttransplant|ITT population, all randomized and transplanted participants. n= participants who have both baseline and postbaseline values.||mg/dL||Standard Deviation|Mean
847488|NCT00555321|Secondary|Mean Change From Baseline in Calculated GFR During the LTE|GFR is a measure of the rate at which blood is filtered by the kidney. MDRD is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine (ScR), age, race, gender, blood urea nitrogen (BUN), and albumin (Alb). GFR (mL/min/1.73 m^2) = 170*(Scr)^-0.999*(Age)^-0.176*(0.762 if female)*(1.180 if African American)*(BUN)^-0.170*(Alb)^+0.318. ). BL= baseline, mL= milliliters; min= minute; m^2= meters squared.|Baseline (pretransplant time point), 1, 2, 3, 6,12, 18, 24, 30, 36 months posttransplant|ITT-LTE population, all randomized and transplanted participants who entered long term extension. n= participants who have both baseline and postbaseline values.||mL/min/1.73 m^2||Standard Deviation|Mean
847489|NCT00555321|Secondary|Mean Change From Baseline in Calculated GFR, by Modification of Diet in Renal Disease (MDRD) Equation: 12-month Treatment Phase|GFR is a measure of the rate at which blood is filtered by the kidney. MDRD is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine (ScR), age, race, gender, blood urea nitrogen (BUN), and albumin (Alb). GFR (mL/min/1.73 m^2) = 170*(Scr)^-0.999*(Age)^-0.176*(0.762 if female)*(1.180 if African American)*(BUN)^-0.170*(Alb)^+0.318. ). BL= baseline, mL= milliliters; min= minute; m^2= meters squared.|Baseline [BL] (pretransplant time point), 1, 2, 3, 6 and 12 months posttransplant|ITT population, all randomized and transplanted participants. n = participants who had both baseline and postbaseline values.||mL/min/1.73 m^2||Standard Deviation|Mean
847490|NCT00555321|Secondary|Mean Change From Baseline in Measured Glomerular Filtration Rate (GFR): 12-month Treatment Phase|GFR was assessed using a true measure of glomerular filtration via iothalamate clearance test. The month 2 time point was selected as the “baseline” time point with respect to measured GFR due to logistical difficulty in obtaining measured GFR at the time of liver transplant and post-transplant renal function largely stabilizing by 2 months. All Measured GFR > 200 were truncated at 200.|Baseline (2 month), 12 months posttransplant|ITT population: all randomized and transplanted subjects. n = participants who had both baseline and postbaseline values.||mL/min/1.73m^2||Standard Deviation|Mean
847491|NCT00555321|Secondary|Number of Participants at Risk of First Acute Rejection as Determined by Kaplan-Meier Method by 12 Months|The time from transplantation to the first AR episode in each treatment arm was summarized using Kaplan-Meier curves. Acute Rejections were clinically suspected and biopsy proven by central pathologist.|3, 6, 9 and 12 months posttransplant|ITT population, all randomized and transplanted participants.||participants|||Number
847492|NCT00555321|Secondary|Number of Participants Having Acute Rejection by Rejection Activity Index During the LTE|Acute Rejections were clinically suspected and biopsy proven by central pathologist. The Banff Rejection Activity Index (RAI) comprises 3 components scored from 0 to 3: venous endothelial inflammation; bile duct inflammation damage; and portal inflammation; the scores are combined to an overall score (the RAI). An overall score of 0-2 is considered indeterminate, score of 3-4 is mild, score of 5-6 is moderate, and score of 7-9 is severe. Only the episode with the highest total RAI score for each participant was counted.|Day 1 (randomization) through End of study (database lock of 20-June-2011)|ITT-LTE population, all randomized and transplanted participants who entered the long-term extension phase.||participants|||Number
847512|NCT00552032|Secondary|Rhinomanometry Results- Left and Right Nasal Fossa: Expiratory Flow at 75 Pa|"Rhinomanometry examination of the left & right Nasal Fossa was performed at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4) in participants ages 7-11 years.
Rhinomanometry is a test of nasal function that measures air pressure and the rate of airflow in the nasal airway during respiration by means of equipment. Expiratory flow was calculated at 75 Pa."|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|This analysis was only performed in a cohort of the ITT in participants ages 7-11 years old (MFSN=19, Placebo=20).||cm^3/sec||Standard Deviation|Mean
847493|NCT00555321|Secondary|Number of Participants With Acute Rejections by Rejection Activity Index (RAI) by 12 Months|Acute Rejections were clinically suspected and biopsy proven by central pathologist. The Banff Rejection Activity Index (RAI) comprises 3 components scored from 0 to 3: venous endothelial inflammation; bile duct inflammation damage; and portal inflammation; the scores are combined to an overall score (the RAI). An overall score of 0-2 is considered indeterminate, score of 3-4 is mild, score of 5-6 is moderate, and score of 7-9 is severe. Only the episode with the highest total RAI score for each participant was counted.|3, 6 and 12 months posttransplant|ITT population: all randomized and transplanted participants||participants|||Number
847494|NCT00555321|Secondary|Number of Participants Who Had Acute Rejection by Banff Grade by 12 Months|Acute Rejections (AR) were clinically suspected and biopsy proven by central pathologist. The Banff grading is a classification of renal allograft pathology and AR. Grade I: AR requiring moderate (>25%) to severe mononuclear cell interstitial infiltrate and moderate tubulitis; Grade II: AR requiring severe tubulitis and/or intimal arteritis; Grade III: AR requiring transmural arteritis. Only the episode with highest Banff grade for each participant was counted.|3, 6 and 12 months posttransplant|ITT population: all randomized and transplanted participants||participants|||Number
847495|NCT00555321|Secondary|Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE|Acute rejections were clinically suspected and biopsy proven by central pathologist. Corticosteroid-resistant rejection = Continued rejection, as documented by liver biopsy, after the completion of 2 days of corticosteroids and requiring use of T-cell depleting agent. Refractory rejection=Continued rejection, as documented by liver biopsy, after use of corticosteroids and T cell depletion therapy. Increase in the dose of TAC was monitored in participants who were assigned to one of the TAC-based regimens. DBL=database lock, TRT=treatment|Day 1 (randomization) through database lock (20-June-2011)|ITT-LTE population, all randomized and transplanted participants who entered long term extension.||participants|||Number
847496|NCT00555321|Secondary|Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months|Acute rejections were clinically suspected and biopsy proven by central pathologist. Corticosteroid-resistant rejection = Continued rejection, as documented by liver biopsy, after the completion of 2 days of corticosteroids and requiring use of T-cell depleting agent. Refractory rejection=Continued rejection, as documented by liver biopsy, after use of corticosteroids and T cell depletion therapy. Increase in the dose of TAC was monitored in participants who were assigned to one of the TAC-based regimens. TRT= treatment|3, 6 and 12 months posttransplant|ITT population: all randomized and transplanted participants||participants|||Number
847497|NCT00555321|Secondary|Number of Participants Having Acute Rejections During the LTE|Acute rejections were clinically suspected and biopsy proven by central pathologist. The number of episodes of AR was counted.|Day 1 (randomization) through database lock (20-June-2011)|ITT-LTE population, all randomized and transplanted participants who entered long-term extension||participants|||Number
847498|NCT00555321|Secondary|Number of Participants Having Acute Rejections: 12-month Treatment Phase|Acute rejections were clinically suspected and biopsy proven by central pathologist. The number of episodes of AR was counted.|3 , 6, and 12 months|ITT population: all randomized and transplanted participants||participants|||Number
847499|NCT00555321|Secondary|Percentage of Participants Who Experienced at Least One Episode of Acute Rejection, Graft Loss, or Death by End of Study (Includes LTE Data)|Any AR that was clinically suspected and biopsy proven (by central pathologist) was included in this triple composite end point. All biopsies for suspected AR were assessed by a central histopathologist using Banff criteria. For 95% CI within each group, normal approximation was used if N>=5, otherwise exact method was used.|Day 1 (randomization) through database lock (20-June-2011)|ITT-LTE population: all randomized and transplanted participants who entered the Long term extension||percentage of participants||95% Confidence Interval|Number
847500|NCT00555321|Secondary|Percentage of Participants Who Experienced at Least One Episode of Acute Rejection, Graft Loss, or Death by 12 Months|Any AR that was clinically suspected and biopsy proven (by central pathologist) was included in this triple composite end point. All biopsies for suspected AR were assessed by a blinded central histopathologist using Banff grading. Graft loss was defined as impairment of liver function to such a degree that the participant died or underwent re-transplantation. For 95% CI within each group, normal approximation is used if N>=5. Otherwise exact method is used. For 95% CI of difference, adjustment is made for randomization strata if N >= 5 in each treatment arm.|At 12 months posttransplant|ITT population: all randomized and transplanted participants||percentage of participants||95% Confidence Interval|Number
847501|NCT00555321|Secondary|Percentage of Participants Surviving With Functional Graft by End of Study (Includes LTE Data)|For 95% CI within each group, normal approximation was used if N>=5, otherwise exact method was used.|Day 1 (randomization) through database lock (20-June-2011)|ITT-LTE population, all randomized and transplanted participants who entered long term extension.||percentage of participants||95% Confidence Interval|Number
847502|NCT00555321|Secondary|Percentage of Participants Surviving With Functional Graft: 12-month Treatment Phase|For 95% CI within each group, normal approximation was used if N>=5. Otherwise exact method was used.|At 6 and 12 months|ITT population: all randomized and transplanted participants.||percentage of participants||95% Confidence Interval|Number
847503|NCT00555321|Primary|Percentage of Participants Who Experienced at Least One Episode of Acute Rejection (AR), Graft Loss, or Death by 6 Months Post-transplant|Any AR that was clinically suspected and biopsy proven (by central pathologist) was included in this triple composite end point. All biopsies for suspected AR were assessed by a blinded central histopathologist using Banff grading schema. Graft loss was defined as impairment of liver function to such a degree that the participant died or underwent re-transplantation. For 95% (confidence interval) CI within each group, normal approximation is used if N>=5, otherwise exact method is used.|At 6 months posttransplant|Intent-to-Treat (ITT) population: all randomized and transplanted participants.||percentage of participants||95% Confidence Interval|Number
847513|NCT00552032|Secondary|Rhinomanometry Results- Left and Right Nasal Fossa: Inspiration Flow at 75 Pa|"Rhinomanometry examination of the left & right Nasal Fossa was performed at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4) in participants ages 7-11 years.
Rhinomanometry is a test of nasal function that measures air pressure and the rate of airflow in the nasal airway during respiration by means of equipment. Inspiration flow was calculated at 75 Pa."|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|This analysis was only performed in a cohort of the ITT in participants ages 7-11 years old (MFSN=19, Placebo=20).||cm^3/sec||Standard Deviation|Mean
847504|NCT00552032|Secondary|Obstructive Sleep Apnea-18 (OSA-18) Questionnaire Total Score|"18 items of the survey were graded on a 7-point ordinal scale. Caregivers were asked to describe how often in the last 4 weeks had the child exhibited specific symptoms according to the following scale: 1: none of the time; 2: hardly any of the time; 3: a little of the time; 4: some of the time; 5: a good bit of the time; 6: most of the time; 7: all of the time. All scores were summed (total score: 18-126).
Grading was as follows:
Scores < 60 suggest a slight impact on health related quality of life (HRQL)
Scores 60-80 suggest a moderate impact
Scores over 80 suggest a great impact"|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|"A total of 132 subjects were included in the ITT population. The ITT population included all randomized participants who received >=1 dose after commencement of treatment. Data summarized in terms of the number of participants providing data at the relevant time point.
1 participant in Placebo group did not answer this questionnaire at baseline."||Score on a scale||Standard Deviation|Mean
847505|NCT00552032|Secondary|Quality of Life Questionnaire (PedsQL) Total Score (Ages 8-12)|The impact on quality of life (QOL) was measured by a general pediatric health questionnaire. Versions were self-administered & answered by participants' parents. This modular instrument consists of 23 items using a 5-point scale: from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. 4 dimensions (physical, emotional, social, & school functioning) are scored. Total score is sum of all the items over the number of items answered on all the scales. Higher scores indicate a better health related QOL.|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|The ITT population included all randomized participants who received >= 1 dose after commencement of treatment. At baseline (visit 2), 28 randomized participants were between 8-12 years old, 15 participants in MFNS & 13 participants in Placebo group. Questionnaire was answered in accordance with the actual age of each participant at each visit.||Score on a scale||Standard Deviation|Mean
847506|NCT00552032|Secondary|Quality of Life Questionnaire (PedsQL) Total Score (Ages 5-7)|The impact on quality of life (QOL) was measured by a general pediatric health questionnaire. Versions were self-administered & answered by participants' parents. Questionnaire consists of 23 items using a 3-point scale: from 0 (not at all), 2 (sometimes), 4 (a lot). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. 4 dimensions (physical, emotional, social, & school functioning) are scored. Total score is sum of all the items over the number of items answered on all the scales. Higher scores indicate a better health related QOL.|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|The ITT population included all randomized participants who received >= 1 dose after commencement of treatment. At baseline (visit 2), 52 randomized participants were between 5 and 7 years old, 28 participants in MFNS & 24 subjects in Placebo group. Questionnaire was answered in accordance with the actual age of each participant at each visit.||Score on a scale||Standard Deviation|Mean
847507|NCT00552032|Secondary|Quality of Life Questionnaire (PedsQL) Total Score (Ages 2-4)|The impact on quality of life (QOL) was measured by a general pediatric health questionnaire. Versions were self-administered & answered by participants' parents. This modular instrument consists of 21 items using a 5-point scale: from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. 4 dimensions (physical, emotional, social, & school functioning) are scored. Total score is sum of all the items over the number of items answered on all the scales. Higher scores indicate a better health related QOL.|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|The ITT population included all randomized participants who received >= 1 dose after commencement of treatment. At baseline (visit 2), 52 randomized participants were between 2 and 4 years old, 23 participants in MFNS & 29 participants in Placebo group. Questionnaire was answered in accordance with the actual age of each participant at each visit.||Score on a scale||Standard Deviation|Mean
847508|NCT00552032|Secondary|Number of Participants With Pediatric Sleep Questionnaire (PSQ)- Impact on Health-Related Quality of Life (HRQL) Results of: Mild, Moderate, or Severe|PSQ consists of 90 variables divided into 3 different factors:snoring, somnolence, and behavior. All positive Snoring and Somnolence answers scored with Yes=1 and No=0, and scores averaged to obtain a total score between 0.00 and 1.00. Behavior factor scored between 1-3, and scores averaged for total score of 1 to 3. Increased scores indicate increasing abnormality of sleep. Based on determined cut-offs, participants were categorized as having mild, moderate, or severe discomfort due to interference of sleep.|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|"A total of 132 participants were included in the ITT population. The ITT
population included all randomized participants who received at least one dose after commencement of treatment. Data summarized in terms of the number of participants providing data at the relevant time point."||Participants|||Number
847509|NCT00552032|Secondary|Acoustic Rhinometry Results- Nasopharyngeal Volume (NPV): Left and Right Nasal Fossa|Acoustic rhinometry examination of the left & right Nasal Fossa was performed by principal investigators at baseline & each visit throughout treatment in participants ages 7-11 years. Acoustic rhinometry is a technique intended for assessment of the geometry of the nasal cavity and nasopharynx and for evaluating nasal obstruction. The technique is based on an analysis of sound waves reflected from the nasal cavities.|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|This analysis was only performed in a cohort of the ITT in participants ages 7-11 years old (MFSN=19, Placebo=20).||cm^3||Standard Deviation|Mean
847510|NCT00552032|Secondary|Acoustic Rhinometry Results- Minimal Cross-Sectional Area: Left and Right Nasal Fossa|"Acoustic rhinometry examination of the left & right Nasal Fossa was performed by principal investigators at baseline & each visit throughout treatment in participants ages 7-11 years. Acoustic rhinometry is a technique intended for assessment of the geometry of the nasal cavity and nasopharynx and for evaluating nasal obstruction. The technique is based on an analysis of sound waves reflected from the nasal cavities.
Measurements were taken for each side of the nose (nasopharyngeal minimum cross-sectional area) & were reported in cm^3."|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|This analysis was only performed in a cohort of the ITT in participants ages 7-11 years old (MFSN=19, Placebo=20).||cm^3||Standard Deviation|Mean
847511|NCT00552032|Secondary|Number of Participants With Pure-Tone Audiometric Results of: Normal, Abnormal, or Not Done|Pure-tone audiometry was performed in children ages 7-11 by certified audiologists. Results were categorized based on audiologist's assessment as either being normal (within normal limits), abnormal (outside normal limits), or audiometry was not done (not performed). Results were assessed at baseline, Week 4 (Visit 3), and endpoint Week 8 (end of treatment).|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|This analysis was only performed in a cohort of the ITT in participants ages 7-11 years old (MFSN=19, Placebo=20).||Participants|||Number
847514|NCT00552032|Secondary|Rhinomanometry Results- Left and Right Nasal Fossa: Expiratory Resistance|"Rhinomanometry examination of the left & right Nasal Fossa was performed at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4) in participants ages 7-11 years.
Rhinomanometry is a test of nasal function that measures air pressure and the rate of airflow in the nasal airway during respiration by means of equipment. These findings were used to calculate expiratory nasal airway resistance reported in Pascal/centimeter^3/second (Pa/cm^3/sec)."|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|This analysis was only performed in a cohort of the ITT in participants ages 7-11 years old (MFSN=19, Placebo=20).||Pa/cm^3/sec||Standard Deviation|Mean
847515|NCT00552032|Secondary|Rhinomanometry Results- Left and Right Nasal Fossa: Inspiratory Resistance|"Rhinomanometry examination of the left & right Nasal Fossa was performed at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4) in participants ages 7-11 years.
Rhinomanometry is a test of nasal function that measures air pressure and the rate of airflow in the nasal airway during respiration by means of equipment. These findings were used to calculate inspiratory nasal airway resistance reported in Pascal/centimeter^3/second (Pa/cm^3/sec)."|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|This analysis was only performed in a cohort of the ITT in participants aged 7-11 years old (MFSN=19, Placebo=20).||Pa/cm^3/sec||Standard Deviation|Mean
847516|NCT00552032|Secondary|Number of Participants With Rhinoscopic- Middle Meatus Results of: Patent, Partial Obstruction or Total Obstruction|Rhinoscopic examination of the middle meatus was performed at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4). Results were categorized based on investigator's assessment into 3 categories: patent (easily observed), partial obstruction (partially blocked from view), or total obstruction (completely blocked from view).|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|A total of 132 participants were included in the ITT population. The ITT population included all randomized participants who received at least one dose after commencement of treatment. Data summarized in terms of the number of participants providing data at the relevant time point.||Participants|||Number
847517|NCT00552032|Secondary|Number of Participants With Rhinoscopic-Inferior Turbinates Results of: Normal, Hypertrophic, and Hypotrophic|Rhinoscopic examination of the inferior turbinates was performed at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4). Results were categorized based on investigator's assessment as either being normal appearance (normal size) , hypertrophic (swollen/normal size increased), or hypotrophic (normal size diminished).|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|A total of 132 participants were included in the ITT population. The ITT population included all randomized participants who received at least one dose after commencement of treatment. Data summarized in terms of the number of participants providing data at the relevant time point.||Participants|||Number
847518|NCT00552032|Secondary|Number of Participants With Rhinoscopic- Septum Results of: Aligned, Non-Obstructive, or Obstructive Deviation|Rhinoscopic examination of the septum was performed at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4). Results were categorized based on investigator's assessment as either being aligned (septum is aligned), non-obstructive (septum is not aligned but the deviation is non-obstructive), or obstructive (septum is deviated and obstructive) deviation.|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|A total of 132 participants were included in the ITT population. The ITT population included all randomized participants who received at least one dose after commencement of treatment. Data summarized in terms of the number of participants providing data at the relevant time point.||Participants|||Number
847519|NCT00552032|Secondary|Number of Participants With Otoscopic Results of: Normal or Abnormal|Otoscopic examination was performed of the right and left ear canals at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4). Results were categorized based on audiologist's assessment as either being normal (ear canal structures appear normal) or abnormal (ear canal structures appear abnormal).|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|A total of 132 participants were included in the ITT population. The ITT population included all randomized participants who received at least one dose after commencement of treatment. Data summarized in terms of the number of participants providing data at the relevant time point.||Participants|||Number
847520|NCT00552032|Secondary|Number of Participants With Bilateral Tympanogram Results of: Normal, Abnormal, or Not Done|Tympanometry was performed in children ages 2-11 by certified audiologists. Results were categorized based on audiologist's assessment as either being normal (normal pressure in the middle ear with normal mobility of the eardrum and the conduction bones) , abnormal (abnormal pressure in the middle ear and/or abnormal mobility of the eardrum and the conduction bones), or tympanometry was not done (evaluation not completed). Results were assessed at baseline, Week 4 (Visit 3), and endpoint Week 8 (end of treatment).|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|"A total of 132 participants were included in the ITT
population. The ITT population included all randomized participants who received at least one dose after commencement of treatment. Data summarized in terms of the number of participants providing data at the relevant time point."||Participants|||Number
847521|NCT00552032|Secondary|Total Frequency Symptom Scores: AM & PM|Symptoms were assessed by whole-number linear scale to grade their frequency. Scores were recorded AM & PM (a difference of 12 hours) & were based on frequency within 12 hours of prior recording. The following signs/symptoms were evaluated: Snoring; Nasal obstruction; and nasal discharge; Breathing difficulty; Oral respiration; Ear pain. Frequency was graded according to the following scale: 0=absent; 1=intermittent; 2=persistent. The frequency of symptoms was scored individually and summed to obtain the Total Frequency Symptom Score. The maximum total score possible was 24 daily; 12 for both AM (6 symptoms times max frequency of 2) and PM.|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|A total of 132 participants were included in the ITT population. The ITT population included all randomized participants who received at least one dose after commencement of treatment. Data summarized in terms of the number of participants providing data at the relevant time point.||Score on a scale||Standard Deviation|Mean
847541|NCT00550459|Secondary|Number of Patients With Serum Chemistry Laboratory Abnormalities: Glucose|Incidence of potentially clinically significant glucose levels post-baseline (normal range=70-125 mg/dL)|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication||participants|||Number
847542|NCT00550459|Secondary|Number of Patients With Serum Chemistry Laboratory Abnormalities: Cholesterol|Incidence of potentially clinically significant cholesterol levels post-baseline (normal range=0-199 mg/dL)|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication||participants|||Number
847522|NCT00552032|Secondary|Total Severity Symptom Scores: Morning and Evening (AM & PM)|Symptoms were assessed by whole-number linear scale to grade their severity. Scores were recorded AM & PM (a difference of 12 hours) & were based on severity within 12 hours of prior recording. The following symptoms were evaluated: Snoring; Nasal obstruction & discharge; Breathing difficulty; Oral respiration; Ear pain. Severity was graded according to the following scale: 0=absent; 1=mild; 2=moderate; 3=severe. Severity was scored individually and summed to obtain the Total Symptom Severity Score. The maximum total score possible was 36 daily; 18 for both AM (6 symptoms times max severity of 3)and PM.|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|A total of 132 participants were included in the ITT population. The ITT population included all randomized participants who received at least one dose after commencement of treatment. Data summarized in terms of the number of participants providing data at the relevant time point.||Score on a scale||Standard Deviation|Mean
847523|NCT00552032|Primary|Change From Baseline in Adenoid/Choana (A/C) Index Grade|Changes in adenoid size were assessed by nasopharyngoscopic examination and were determined using the Adenoid/Choana (A/C) Index. Grades were assigned to intervals of A/C ratio percentages: grade I (0-25%), II (26-50%), III (51-75%) and IV (76-100%). Changes in adenoid size were expressed as the mean difference between grades at baseline and study visit. Positive values indicated a decrease in adenoid size, a 0 value indicated that size remained the same, and negative values indicated an increase in adenoid size.|Baseline (visit 2), Weeks 4 (visit 3), Week 8 (visit 4)|A total of 132 participants were included in the intent-to-treat (ITT) population. The ITT population included all randomized participants who received at least one dose after commencement of treatment. Data are summarized in terms of the number of participants providing data at the relevant time point.||Score on a Scale||Standard Deviation|Mean
847524|NCT00550589|Secondary|Changes in Gene Expression in Perianal HSIL After Exposure to Cidofovir as Assessed by RNA Microarray Analysis||Baseline, after cycle 1, and 6 weeks after treatment discontinuation|The gene expression analysis was not done|||||
847525|NCT00550589|Secondary|Distribution of Abnormally Methylated Genes Among HSIL, Low-grade Squamous Intraepithelial Lesions, and Normal Perianal Skin||Baseline, after cycle 1, and 6 weeks after treatment discontinuation|The gene analysis was not done|||||
847526|NCT00550589|Secondary|Identification of Abnormally Methylated Genes in Perianal Dysplasia|Identification of abnormally methylated genes in perianal dysplasia|Baseline, after cycle 1, and 6 weeks after treatment discontinuation|The lab analysis of genes was not performed|||||
847527|NCT00550589|Secondary|Identification of HPV-DNA Types Present in the Anus|Number of patients with HPV16 type present in the anus from anal swab or cytobrush at baseline|Baseline|Number of patients with anal swabs or cytobrush results at baseline||participants|||Number
847528|NCT00550589|Secondary|Correlation of Clinical Regression of Perianal HSIL With Clearance of HPV DNA|Number of patients who cleared HPV among those who had a complete or partial response|6 weeks after treatment discontinuation|Participants who had a partial or complete response and for whom pre and post-treatment HPV data were available||participants|||Number
847529|NCT00550589|Secondary|Human Papilloma Virus (HPV) DNA Type in Perianal HSIL and Normal Perianal Tissue|Number of patients with HPV16 at baseline in perianal HSIL and normal perianal tissue|Baseline|Number of patients with tissue samples available at baseline||participants|||Number
847530|NCT00550589|Primary|Safety and Tolerability of Topical Cidofovir as Assessed by NCI CTCAE v3.0|Number of study patients who had a serious adverse event|Every 2 weeks on study, 6 weeks after treatment discontinuation|All enrolled patients||participants|||Number
847531|NCT00550589|Primary|Proportion of Patients With Regression of Perianal High-grade Squamous Intraepithelial Lesions (HSIL)||6 weeks after treatment discontinuation|||proportion of participants|||Number
847532|NCT00550459|Secondary|Number of Patients With Electrocardiogram (ECG) Abnormalities: Arrhythmia|Incidence of potentially clinically significant ECG abnormalities: arrhythmia|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication||participants|||Number
847533|NCT00550459|Secondary|Number of Patients With Electrocardiogram (ECG) Abnormalities: Right Bundle Branch Block (RBBB), Left Bundle Branch Block (LBBB), Myocardial Infarction (MI)|Incidence of potentially clinically significant ECG abnormalities: Right bundle branch block (RBBB), Left bundle branch block (LBBB), myocardial infarction (MI)|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication||participants|||Number
847534|NCT00550459|Secondary|Number of Patients With Electrocardiogram (ECG) Abnormalities: T Wave|Incidence of potentially clinically significant ECG abnormalities: T wave|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication||participants|||Number
847535|NCT00550459|Secondary|Number of Patients With Electrocardiogram (ECG) Abnormalities: ST Segment|Incidence of potentially clinically significant ECG abnormalities: ST Segment|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication||participants|||Number
847536|NCT00550459|Secondary|Number of Patients With Electrocardiogram (ECG) Abnormalities: QTcF Increase 30-60 Msec|Incidence of potentially clinically significant ECG abnormalities (QTcF increase 30-60 msec post-baseline)|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication||participants|||Number
847537|NCT00550459|Secondary|Number of Patients With Electrocardiogram (ECG) Abnormalities: QTcB Increase 30-60 Msec|Incidence of potentially clinically significant ECG abnormalities (QTcB increase 30-60 msec)|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication||participants|||Number
847538|NCT00550459|Secondary|Number of Patients With Electrocardiogram (ECG) Abnormalities: QRS Interval|Incidence of potentially clinically significant ECG abnormalities involving QRS interval (change > 100 msec)|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication||participants|||Number
847539|NCT00550459|Secondary|Number of Patients With Electrocardiogram (ECG) Abnormalities: QT >500 Milliseconds (Msec)|Incidence of potentially clinically significant ECG abnormalities (QT>500 msec) post-baseline|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication||participants|||Number
847540|NCT00550459|Secondary|Number of Patients With Serum Chemistry Laboratory Abnormalities: Magnesium|Incidence of potentially clinically significant magnesium levels post-baseline (normal range=1.2-2 mEq/L)|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication||participants|||Number
847545|NCT00550459|Secondary|Number of Patients With Hematology Laboratory Abnormalities: Neutrophils|Incidence of potentially clinically significant neutrophil count post-baseline (normal range=1.8-8 thousands/microliter)|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication||participants|||Number
847546|NCT00550459|Secondary|Number of Patients With Hematology Laboratory Abnormalities: Lymphocytes|Incidence of potentially clinically significant lymphocyte count post-baseline (normal range = 16-46%)|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication||participants|||Number
847547|NCT00550459|Secondary|Number of Patients With Hematology Laboratory Abnormalities: Activated Partial Thromboplastin Time (aPTT)|Incidence of potentially clinically significant Activated Partial Thromboplastin Time (aPTT) levels post-baseline (normal range=22-34 seconds)|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication||participants|||Number
847548|NCT00550459|Secondary|Number of Patients With Hematology Laboratory Abnormalities: Hemoglobin|Incidence of clinically significant hemoglobin abnormalities post-baseline (normal range=11.8-16.8 g/dL)|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication||participants|||Number
847549|NCT00550459|Secondary|Number of Patients With Vital Sign Abnormalities: Body Temperature|Incidence of potentially clinically significant changes in body temperature post-baseline (defined as an increase of >=1.1 to >=38.3 degrees Celsius)|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication||participants|||Number
847550|NCT00550459|Secondary|Number of Patients With Vital Sign Abnormalities: Body Weight|Incidence of clinically significant body weight change post-baseline (defined as change upward or downward of >=7%)|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication||participants|||Number
847551|NCT00550459|Secondary|Number of Patients With Vital Sign Abnormalities: Pulse Rate|Incidence of abnormal pulse rate post-baseline [abnormal values: >=120 beats per minute (bpm) + increase of >=15 bpm; <=50 bpm + decrease of >=15 bpm]|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication||participants|||Number
847552|NCT00550459|Secondary|Number of Patients With Vital Sign Abnormalities: Blood Pressure|Incidence of abnormal systolic & diastolic blood pressure values post-baseline (abnormal systolic values: >=180 mmHg + increase of >=20 mmHg, <= 90 mmHg + decrease >=20 mmHg; abnormal diastolic values: >=105 mmHg+increase of >=15 mmHg, <=50 mmHg + decrease of >= 15 mmHg)|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication||participants|||Number
847553|NCT00550459|Secondary|Change From Baseline in Serum Sodium; ITT Population|Change from Baseline to Day 22 in Serum Sodium; ITT population|Baseline and Day 22|ITT population with OC||mEq/L||Standard Deviation|Mean
847554|NCT00550459|Secondary|Change From Baseline in Postural Stability Test|Change from baseline to Day 22 in Postural Stability Test Z-score (This test measures gross motor control. The ability to stand upright without moving is assessed using the SWAY meter that is modeled on the Wright Ataxiameter. A cord from the meter is attached to the subject who is required to stand as still as possible with feet apart and eyes closed for 1 minute. The test is then repeated with eyes open for 1 minute. The outcomes of these tests are combined and measured as a movement Z-score. Higher result=better postural stability); ITT population|baseline and Day 22|ITT population with LOCF (this group includes missing values)||Z-score||Standard Deviation|Mean
847555|NCT00550459|Secondary|Change From Baseline in Gait Test (Timed Get-Up-and-Go Test)|Change from baseline to Day 22 in Gait Test (Timed Get-Up-and-Go Test=time it takes for a seated subject to rise from a chair, walk 3 meters, walk around an object and return to sit in chair. Values: under 10 sec (no difficulties), 10 to 20 sec (starting to have balance difficulty), over 30 sec (at high risk for falls and dependent in most activities of daily living and mobility); test assesses risk to elderly subjects of falling and higher scores in seconds indicate higher risk of falling; ITT population|baseline and Day 22|ITT population with OC||Seconds||Standard Deviation|Mean
847556|NCT00550459|Secondary|Change From Baseline in Overall Neurocognitive Composite Score|Change from Baseline to Day 22 in the overall Neurocognitive Composite Score (NCS)comprising the sum of 7 neurocognitive domain Z-scores (Reaction Time, Psychomotor Speed, Processing Speed, Continuity of Attention, Working Memory/Executive Functions, Quality of Episodic Verbal Memory, and Postural Stability); ITT population|baseline and Day 22|ITT population with OC||Z-score||Standard Deviation|Mean
847557|NCT00550459|Secondary|Change From Baseline in the Individual Neurocognitive Domains Included in the Primary Endpoint: Processing Speed of Rapid Visual Information Processing Test, Numeric Working Memory Test, and Word Recognition Test|Change from baseline to Day 22 in the individual neurocognitive domains Z-score for Processing Speed of Rapid Visual Information Processing Test, Numeric Working Memory Test, and Word Recognition Test; ITT population|baseline and Day 22|ITT population with OC||Z-score||Standard Deviation|Mean
847558|NCT00550459|Secondary|Change From Baseline in the Individual Neurocognitive Domains Included in the Primary Endpoint: Psychomotor Speed Via Morse Tapping Test|Change from baseline to Day 22 in the individual neurocognitive domains Z-score for Psychomotor Speed (mean tap rate of Morse tapping test); ITT population|baseline and Day 22|ITT population with OC||Z-score||Standard Deviation|Mean
847559|NCT00550459|Secondary|Change From Baseline to Day 22 in the Individual Neurocognitive Domains Included in the Primary Endpoint: Reaction Time in Computer Tests|Change from baseline in the individual neurocognitive domains Z-score for Reaction Time in Computer Tests (simple reaction time test, choice reaction time test, digit vigilance test); ITT population|baseline and Day 22|ITT population with OC||Z-score||Standard Deviation|Mean
847560|NCT00550459|Primary|Change From Baseline in the Neurocognitive Composite Score of Speed Domains (NCS-SD; Sum of All Correct Speed Domain Z-Scores)|"Change from baseline to Day 22 in sum of all speed domain Z-scores:Reaction Time (Simple=recognize yes 50 times;Choice=recognize yes or no 50 times;Digit Vigilance=match 45 digits);Psychomotor Speed (Morse Tapping=tap button for 30 seconds with right & left hands);Processing Speed (Rapid Visual Information Processing=detect consecutive sequences of 3 odd or 3 even digits;Numeric Working Memory=recognize numbers from series of 5 digits among 30;Word Recognition=remember 15 prior learned words from 30 total;results age-matched to healthy controls from Cognitive Drug Research normative data"|baseline and Day 22|Analysis based upon observed cases (OC).||Z-score||Standard Deviation|Mean
847613|NCT00526890|Primary|Incidence of Grade 3-4 Pneumonitis||During study treatment, up to 6 weeks|Patients treated with study therapy||percentage of participants||95% Confidence Interval|Number
847561|NCT00545584|Secondary|Fasting Plasma Glucose (FPG) Measurement|Generally FPG values of ~5.0–7.2 mmol/L would be considered goal (American Diabetes Association).|Baseline and Week 24|FAS population. Furthermore, only 350, 252, and 350 subjects had FPG evaluations in the Diet advice, Diet & physical activity advice, and Standard groups, respectively, at Baseline; and 303, 224, and 310 subjects had FPG evaluations in the Diet advice, Diet & physical activity advice, and Standard groups, respectively, at Week 24.||mmol/L glucose||Standard Deviation|Mean
847562|NCT00545584|Primary|Hemoglobin A1c Measurement|Hemoglobin A1c (HbA1c) is a measure of glycated hemoglobin in the blood. HbA1c greater than 6.5% was considered inadequately controlled.|Baseline and Week 24|The Full Analysis Set (FAS) population included all selected patients with at least one measured HbA1c value after Visit 2 and having received at least one dose of sitagliptin. In the Standard of Care group, only 360 subjects had HbA1c Baseline evaluations.||percent HbA1c||Standard Deviation|Mean
847563|NCT00537316|Secondary|Proportion of Participants With Mucosal Healing During Part 2 of the Study|Due to the early termination of this study, evaluations of efficacy were not conducted for Part 2 of the study|Weeks 38, 62 and 94 (Weeks 22, 46 and 78 for direct entry)||||||
847564|NCT00537316|Secondary|Proportion of Participants Who Are in Steroid-free Remission During Part 2 of the Study|Due to the early termination of this study, evaluations of efficacy were not conducted for Part 2 of the study.|Weeks 38, 62 & 94 (Weeks 22, 46 and 78 for direct entry)||||||
847565|NCT00537316|Secondary|Proportion of Participants With Mucosal Healing at Week 16|Mucosal healing was defined as a Mayo endoscopy score of 0 or 1.|16 weeks|Full Analysis Set (participants who were randomized, received at least one dose of study treatment, and had data available for baseline and at least one post baseline evaluation).||Proportion of participants|||Number
847566|NCT00537316|Secondary|Proportion of Participants in Response at Weeks 8 and 16|Response at Week 8 is defined as a decrease in the partial Mayo score of ≥1 point. Response at Week 16 is defined as a decrease in total Mayo score of ≥3 points and at least 30% lower than baseline Mayo score. The partial Mayo score consists of the following 3 sub-scores: stool frequency, rectal bleeding, and physician’s global assessment. The total Mayo score consists of the following 4 sub-scores: stool frequency, rectal bleeding, findings of endoscopy (sigmoidoscopy), and physician’s global assessment.|Weeks 8 and 16|Full Analysis Set (participants who were randomized, received at least one dose of study treatment, and had data available for baseline and at least one post baseline evaluation). Participants who dropped out prior to Week 16, had a missing Mayo score at Week 16, or were non-responders at Week 8 are considered failures (non-responders) at Week 16.||Proportion of participants|||Number
847567|NCT00537316|Primary|Average Remission Rate During Part 2 of the Study|Due to the early termination of this study, evaluations of efficacy were not conducted for Part 2 of the study (Week 38 through Week 94 [Week 22 through Week 78 for direct entry]).|up to Week 94 (Week 78 for direct entry)||||||
847568|NCT00537316|Primary|Proportion of Participants in Steroid-free Remission at Week 16|Steroid-free remission is defined as a total Mayo score of 2 points or lower, with no individual sub-score exceeding 1 point, without the use of corticosteroids. The total Mayo score consists of the following 4 sub-scores: stool frequency, rectal bleeding, findings of endoscopy (sigmoidoscopy), and physician’s global assessment.|16 weeks|Full Analysis Set (participants who were randomized, received at least one dose of study treatment, and had data available for baseline and at least one post baseline evaluation). Participants who dropped out prior to Week 16, had a missing Mayo score at Week 16, or were non-responders at Week 8 are considered failures (non-remission) at Week 16.||Proportion of participants|||Number
847569|NCT00527735|Secondary|Overall Survival in Participants With SCLC|Overall Survival is defined as the time from the date of randomization until the date of death. For participants who have not died, Overall Survival was censored at the recorded last date of contact; participants with a missing recorded last date of contact were censored at the last date the participant was known to be alive.|Randomization date to date of death (of censored, maximum reached: 22 months)|All participants with SCLC who were randomized to a treatment group.||Months||95% Confidence Interval|Median
847570|NCT00527735|Secondary|Number of Participants With SCLC Who Have Positive HAHA Status Postbaseline|An electrochemilumiluminescent immunoassay was used to detect HAHA antibodies to ipilimumab in human serum. Baseline, either negative or positive, is the maximum of all measurements closest and prior to the first ipilimumab dose. Positive status postbaseline=participants with an increase in HAHA measurement from baseline.|Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment|Participants with SCLC who had at least 1 HAHA measurement prior to and at least 1 after the first ipilimumab dose and with an increase in HAHA measurement from baseline.||Participants|||Number
847571|NCT00527735|Secondary|Number of Participants With SCLC Who Had Abnormalities in Vital Sign Measurements and Physical Examination Findings|Vital signs measurements consisted of systolic and diastolic blood pressure, heart rate, temperature, and respiratory rate. Physical examinations assessed weight, height, performance status, and body surface area.|Predose Day 1; Weeks 4, 7, 10, 13, 16, and 24; and every 12 weeks on maintenance until end of treatment|All participants with SCLC who received at least 1 dose of ipilimumab/placebo and/or chemotherapy and had at least 1 on-study measurement available.||Participants|||Number
847572|NCT00527735|Secondary|Progression-free Survival (PFS) in Participants With SCLC Per mWHO Criteria|By mWHO criteria, PFS is defined as the time between the randomization date and the date of progression or death, whichever occurs first. For participants with no recorded postbaseline tumor assessment, PFS was censored at the day of randomization. A participant who died without reported prior progression was considered to have progressed on the date of death. For those who remain alive and have not progressed, PFS was censored on the date of last evaluable tumor assessment.|Randomization date to date of progression or death (of censored, maximum reached: 22 months)|All participants with SCLC who were randomized to a treatment group.||Months||95% Confidence Interval|Mean
847573|NCT00527735|Secondary|Percentage of Participants With SCLC Who Have Abnormalities in Pancreatic Enzyme and Other Clinical Laboratory Test Results by Worst CTC Grade|ULN=upper limit of normal. Lipase (U/L) Grade (Gr) 1: 1.1 to 1.39*ULN; Gr 2: >1.5 to 2.0*ULN; Gr 3: 2.5 to 5; Gr 4: 5*ULN. Amylase (U/L) Gr 1: >ULN to 1.5*ULN; Gr 2 >1.5 to 2.0*ULN, Gr 3 >2.0 to 5.0*ULN, Gr 4 >5.0*ULN. Creatine (mg/dL) Gr 1: >ULN to 1.5*ULN, Gr 2: 1.5 to 3.0*ULN, Gr 3: >3.0 to 6.0*ULN, Gr 4: >6.0*ULN.|At screening, predose Day 1, and Weeks 4, 7, 10, 13, 16, 19, 24, and at end of treatment|All participants with SCLC who received at least 1 dose of ipilimumab and/or chemotherapy and had at least 1 on-study pancreatic enzyme or other laboratory test measurement available.||Percentage of participants|||Number
847574|NCT00527735|Secondary|Number of Participants With SCLC Who Have Abnormalities in Liver Function Test Results by Worst CTC Grade|ALT=alanine aminotransferase; AST=aspartate aminotransferase; ALK=alkaline phosphatase. ULN=Upper limit of normal among all laboratory ranges. CTC grade criteria: ALT Grade 1:>ULN to 2.5*ULN; Grade 2: >2.5 to 5.0*ULN; Grade 3: >5.0 to 20.0*ULN; Grade 4: >20.0*ULN. AST Grade 1: >ULN to 2.5*ULN; Grade 2: >2.5 to 5.0*ULN; Grade 3: >5.0 to 20.0*ULN; Grade 4: >20.0*ULN. Total bilirubin Grade 1: >ULN to 1.5*ULN; Grade 2: >1.5 to 3.0*ULN; Grade 3: >3.0 to 10.0*ULN; Grade 4: >10.0*ULN. ALK (U/L) G1:>ULN to 2.5*ULN, G2:>2.5 to 5.0*ULN, G3:>5.0 to 20.0*ULN, G4:>20.0*ULN.|At screening; predose Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment|All participants with SCLC who received at least 1 dose of ipilimumab/placebo and/or chemotherapy and had at least 1 on-study liver function test result available.||Participants|||Number
847575|NCT00527735|Secondary|Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade|CTC, Version 3 used to assess parameters. LLN=lower limit of normal. CTC criteria: ANC=absolute neutrophil count. White blood cells Gr 1:<LLN to 3.0*10^9/L, Gr 2:<3.0 to 2.0*10^9/L, Gr 3:<2.0 to 1.0*10^9/L, Gr 4:<1.0*10^9/L. ANC Gr 1:<LLN to 1.5*10^9/L, Gr 2:<1.5 to 1.0*10^9/L, Gr 3:<1.0 to 0.5*10^9/L, Gr 4:<0.5*10^9/L. Platelet count Gr 1:LLN to 75.0*10^9/L, Gr 2:<75.0 to 50.0*10^9/L, Gr 3:<50.0 to 25.0*10^9/L, Gr 4:<25.0 to 10^9/L. Hemoglobin Gr 1:<LLN to 10.0 g/dL, Gr 2:<10.0 to 8.0 g/dL, Gr 3:<8.0 to 6.5 g/dL, Gr 4:<6.5 g/dL.|At screening, predose Day 1, and Weeks 4, 7, 10, 13, 16, 19, 24, and at end of treatment|All participants with SCLC who received at least 1 dose of ipilimumab and/or chemotherapy and had at least 1 on-study hematology test result available.||Participants|||Number
847576|NCT00527735|Secondary|Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=possibly, probably, or certainly related to and of unknown relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.|Weeks 4, 7, 10, 16, 19, and 24; at end of treatment; and at follow-up (70 days from last dose)|All participants with SCLC who received at least 1 dose of blinded active or placebo ipilimumab with or without paclitaxel/carboplatin.||Participants|||Number
847577|NCT00527735|Secondary|Number of Participants With NSCLC Who Have Positive Human Antihuman Antibody (HAHA) Status Postbaseline|An electrochemilumiluminescent immunoassay was used to detect HAHA antibodies to ipilimumab in human serum. Baseline, either negative or positive, is the maximum of all measurements closest and prior to the first ipilimumab dose. Positive status postbaseline=participants with an increase in HAHA measurement from baseline.|Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment|Participants with at least 1 HAHA measurement prior to and at least 1 after the first ipilimumab dose and with an increase in HAHA measurement from baseline.||Participants|||Number
847578|NCT00527735|Secondary|Percentage of Participants With NSCLC Who Have Abnormalities in Pancreatic Enzyme Clinical Laboratory Test Results by Worst CTC Grade|ULN=upper limit of normal. Lipase (U/L) Gr 1: 1.1 to 1.39*ULN; Gr 2: >1.5 to 2.0*ULN; Gr 3: 2.5 to 5; Gr 4: 5*ULN. Amylase (U/L) Gr 1: >ULN to 1.5*ULN; Grade 2 >1.5 to 2.0*ULN, Grade 3 >2.0 to 5.0*ULN, Grade 4 >5.0*ULN. Creatine (mg/dL) Grade 1: >ULN to 1.5*ULN, Gr 2: 1.5 to 3.0*ULN, Gr 3: >3.0 to 6.0*ULN, Gr 4: >6.0*ULN.|At screening; predose Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment|All participants with NSCLC who received at least 1 dose of ipilimumab/placebo and/or chemotherapy and had at least 1 on-study pancreatic enzyme laboratory test measurement available. One NSCLC participant randomized to the sequential arm is included in the concurrent arm for safety evaulations.||Percentage of participants|||Number
847579|NCT00527735|Secondary|Number of Participants With NSCLC Who Had Abnormalities in Vital Sign Measurements and Physical Examination Findings|Vital signs measurements consisted of systolic and diastolic blood pressure, heart rate, temperature, and respiratory rate. Physical examinations assessed weight, height, performance status, and body surface area.|At screening; Day 1; Weeks 4, 7, 10, 13, 16, and 24; and every 12 weeks on maintenance until disease progression, study closure, or withdrawal of consent|All participants with NSCLC who received at least 1 dose of ipilimumab/placebo and/or chemotherapy and had at least 1 on-study measurement available.One NSCLC participant randomized to the sequential arm is included in the concurrent arm for safety evaulations.||Participants|||Number
847580|NCT00527735|Secondary|Number of Participants With NSCLC Who Have Abnormalities in On-Study Liver Function Test Results By Worst CTC Grade|ULN=Upper limit of normal among all laboratory ranges. ALT=alanine transaminase; AST=aspartate aminotransferase; ALK=alkaline phosphatase. CTC grade criteria: ALT Grade 1:>ULN to 2.5*ULN; Grade 2: >2.5 to 5.0*ULN; Grade 3: >5.0 to 20.0*ULN; Grade 4: >20.0*ULN. AST Grade 1: >ULN to 2.5*ULN; Grade 2: >2.5 to 5.0*ULN; Grade 3: >5.0 to 20.0*ULN; Grade 4: >20.0*ULN. Total bilirubin Grade 1: >ULN to 1.5*ULN; Grade 2: >1.5 to 3.0*ULN; Grade 3: >3.0 to 10.0*ULN; Grade 4: >10.0*ULN. ALK (U/L) G1:>ULN to 2.5*ULN, G2:>2.5 to 5.0*ULN, G3:>5.0 to 20.0*ULN, G4:>20.0*ULN.|At screening; predose Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and every 12 weeks on maintenance until disease progression, study closure, or withdrawal of consent|All participants with NSCLC who received at least 1 dose of ipilimumab and/or chemotherapy and had at least 1 on-study liver function measurement available. One NSCLC participant randomized to the sequential arm is included in the concurrent arm for safety evaulations.||Participants|||Number
847581|NCT00527735|Secondary|irPFS in Participants With SCLC Per irRC|IRC performed TA.|Randomization date to date of irPD or death (maximum reached: 22 months)|All participants with SCLC who were randomized to a treatment group.||Months||95% Confidence Interval|Mean
847614|NCT00526890|Primary|Incidence of Grade 3-4 Esophagitis||During study treatment, up to 6 weeks|Treated with Study Therapy||percentage of participants||95% Confidence Interval|Number
847615|NCT00524589|Secondary|Expression of VDR and CYP24 in Peripheral Blood Mononuclear Cells as Assessed at Baseline and on Days 2 and 3||1 year||||||
847616|NCT00524589|Primary|Objective Response (Complete or Partial Response)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|1 year|All treated and eligible patients||percentage of participants|||Number
847617|NCT00500682|Secondary|Vitamins and Folate Levels||approximately 42 months||||||
847582|NCT00527735|Secondary|Percentage of Participants With NSCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade|CTC, Version 3 used to assess parameters. LLN=lower limit of normal. CTC criteria: ANC=absolute neutrophil count. White blood cells Grade (Gr) 1:<LLN to 3.0*10^9/L, Gr 2:<3.0 to 2.0*10^9/L, Gr 3:<2.0 to 1.0*10^9/L, Gr 4:<1.0*10^9/L. ANC Gr 1:<LLN to 1.5*10^9/L, Gr 2:<1.5 to 1.0*10^9/L, Gr 3:<1.0 to 0.5*10^9/L, Gr 4:<0.5*10^9/L. Platelet count Gr 1:LLN to 75.0*10^9/L, Gr 2:<75.0 to 50.0*10^9/L, Gr 3:<50.0 to 25.0*10^9/L, Gr 4:<25.0 to 10^9/L. Hemoglobin Gr 1:<LLN to 10.0 g/dL, Gr 2:<10.0 to 8.0 g/dL, Gr 3:<8.0 to 6.5 g/dL, Gr 4:<6.5 g/dL.|At screening; predose Day 1; and Weeks 4, 7, 10, 13, 16, 19, and 24; and every 12 weeks on maintenance until disease progression, study closure, or withdrawal of consent|All participants with NSCLC who received at least 1 dose of ipilimumab/placebo and/or chemotherapy and had at least 1 on-study hematology test result available. One NSCLC participant randomized to the sequential arm is included in the concurrent arm for safety evaulations.||Percentage of participants|||Number
847583|NCT00527735|Secondary|Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=possibly, probably, or certainly related to and of unknown relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.|Weeks 4, 7, 10, 16, 19, and 24; at end of treatment; and at follow-up (70 days from last dose)|All participants with NSCLC who received at least 1 dose of blinded active or placebo ipilimumab with or without paclitaxel/carboplatin. One NSCLC participant randomized to the sequential arm is included in the concurrent arm for safety evaulations.||Participants|||Number
847584|NCT00527735|Secondary|Immune-related Duration of Response (irDoR) Per irRC and DoR Per mWHO Criteria in Participants With NSCLC and SCLC|irDoR is defined as the time between the date of response of confirmed irCR or irPR and the date of irPD or death, whichever occurs first. For those participants who remain alive and did progress following response, irDoR was censored on the date of last evaluable tumor assessment. By mWHO criteria, DoR is defined as the time between the date of response of confirmed CR or PR and the date of PD or death, whichever occurs first. For those who remain alive and did not progress following response, DoR was censored on the date of last evaluable tumor assessment.|Date of irCR or irPR to date of irPD or death (maximum reached: 14.2 months)|All participants who were randomized to a treatment group.||Months||95% Confidence Interval|Median
847585|NCT00527735|Secondary|Immune-related Disease Control Rate (irDCR) Per irRC and Disease Control Rate (DCR) Per mWHO Criteria in Participants With NSCLC and SCLC|irDCR is defined as the proportion of participants whose immune-related best overall response is irPR, irCR, or immune-related Stable Disease (irSD) in the analysis data set. irSD=Does not meet criteria for irCR or irPR, in the absence of progressive disease. By mWHO criteria, DCR is defined as the proportion of participants whose best overall response is PR, CR, or SD in the analysis data set. SD=A decrease or tumor stabilization of 1 or more nonindex lesions. Independent review committee assessed response.|Tumor assessment at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance until irPD, progressive disease, or death (maximum reached: 22 months)|All participants who were randomized to a treatment group.||Percent of participants||95% Confidence Interval|Number
847586|NCT00527735|Secondary|Immune-related Best Overall Response Rate (irBORR) Per irRC in Participants With NSCLC and Small-cell Lung Cancer (SCLC)|irBORR=number of participants with irBORR of immune-related Complete Response (irCR) or immune-related Partial Response (irPR), divided by total participants in the data set. irCR=Complete disappearance of all index lesions. irPR=Decrease, relative to baseline, of 50% or greater in the sum of the products of the 2 largest perpendicular diameters of all index and of all new measurable lesions. Independent review committee performed the tumor assessments.|Tumor assessment at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance|All participants who were randomized to a treatment group.||Percentage of participants||95% Confidence Interval|Number
847587|NCT00527735|Secondary|Best Overall Response Rate (BORR) Per mWHO Criteria in Participants With NSCLC and SCLC|mWHO criteria define BORR as the number of patients with best overall response of Complete Response (CR) or Partial Response (PR), divided by the total number of participants in the data set (multiplied by 100 for percentage). CR=Complete disappearance of all index lesions; PR=decrease from baseline of >=50% in the sum of products of the 2 largest perpendicular diameters of all index lesions. Independent review committee performed tumor assessment.|Tumor assessment at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance|All participants who were randomized to a treatment group.||Percentage of participants||95% Confidence Interval|Number
847588|NCT00527735|Secondary|Overall Survival in Participants With NSCLC|Overall Survival is defined as the time from the date of randomization until the date of death. For participants who have not died, Overall Survival was censored at the recorded last date of contact; participants with a missing recorded last date of contact were censored at the last date the participant was known to be alive.|Randomization date to date of death (of censored, maximum reached: 26.5 months)|All NSCLC participants who were randomized to a treatment group.||Months||95% Confidence Interval|Median
847589|NCT00527735|Secondary|Progression-free Survival (PFS) in Participants With NSCLC Per Modified World Health Organization (mWHO) Criteria|By mWHO criteria, PFS is defined as the time between the randomization date and the date of progression or death, whichever occurs first. For participants with no recorded postbaseline tumor assessment, PFS was censored at the day of randomization. A participant who died without reported prior progression was considered to have progressed on the date of death. For those who remain alive and have not progressed, PFS was censored on the date of last evaluable tumor assessment. Independent review committee performed tumor assessment.|Randomization date to date of progression or death (of censored, maximum reached: 13.6 months)|All NSCLC participants who were randomized to a treatment group.||Months||95% Confidence Interval|Mean
847618|NCT00500682|Secondary|The Development of a Component of a Quadruple Composite Endpoint (Initiation of Dialysis, Kidney Transplant, Doubling of sCr, or Death), Other Measures of Renal Function||approximately 42 months||||||
847619|NCT00500682|Primary|Safety and Tolerability||approximately 42 months||||||
847590|NCT00527735|Primary|Immune-related Progression-free Survival (irPFS) in Participants With Nonsmall-cell Lung Cancer (NSCLC) Per Immune-related Response Criteria (irRC)|irPFS is defined as the time between the randomization date and date of immune-related Progressive Disease (irPD) (at least 25% increase percentage change in total tumor burden, including new lesions) or death, whichever occurs first. For patients with no recorded postbaseline tumor assessments, irPFS is censored at randomization. Participant who die without reported irPD are considered to have progressed on the date of death. For those who remain alive and have no irPD, irPFS is censored on the date of last evaluable tumor assessment. Independent review committee performed tumor assessment.|Tumor assessed at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance until immune-related Progressive Disease (irPD) or death (of censored, maximum reached: 16.5 months)|All participants with NSCLC who were randomized to a treatment group.||Months||95% Confidence Interval|Median
847591|NCT00527488|Secondary|Pharmacokinetic Parameters of Degarelix: Tmax|The time for maximal concentration (tmax) was determined for data up to Day 42|Day 0-42|||Days||Standard Deviation|Mean
847592|NCT00527488|Secondary|Pharmacokinetic Parameters of Degarelix: Cmax|Cmax was determined for concentration measurements up to Day 42|Day 0-42|||ng/mL||Standard Deviation|Mean
847593|NCT00527488|Primary|Interntional Iindes of Erectile Function (IIEF) Score: Overall Satisfaction|The IIEF contains 15 items in 5 domains: Erectile Function (6 items), Orgasmic Function (2 items), Sexual Desire (2 items), Intercourse Satisfaction (3 items), and Overall Satisfaction (2 items). Item are scored on a scale from ‘No sexual activity’ to ‘Almost always to always’. For the Erectile Function domain, a score of 1-10 indicates severe erectile dysfunction and 26-30 no dysfunction, the minimum score being 1 and the maximum 30. For all other domains, a higher score indicates less dysfunction. The IIEF does not yield a total score.|Day 0-42|||Units on a scale||Standard Deviation|Mean
847594|NCT00527488|Primary|IPSS Global Quality of Life|"Patients were asked about how they would feel if they were to spend the rest of their lives with their prostate symptoms just as they are now. The answers choices range from delighted to terrible or 0 to 6."|Day 0-42|||Units on a scale||Standard Deviation|Mean
847595|NCT00527488|Primary|International Prostate Specific Symptom (IPSS) Score|The IPSS is a patient-administered questionnaire containing seven items to evaluate symptoms of urinary obstruction (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, nocturia) over the preceding week. Each urinary symptom question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The total score can therefore range from 0 to 35 (0-7: mildly symptomatic; 8-19: moderately symptomatic; 20-35: severely symptomatic).|Day 0-42|||Units on a scale||Standard Deviation|Mean
847596|NCT00527488|Primary|Post-void Residual Urine Volume|The post-void residual urine volume in the bladder was evaluated by transabdominal ultrasound. The urine bladder was sonicated from two directions perpendicular to one another, and the volume calculated automatically.|Day 0-42|||mL||Full Range|Mean
847597|NCT00527488|Primary|Maximal Urinary Flow|Urinary flow was determined by flowmetry using a device that fulfils the International Continence Society standards for maximum urinary flow.|Day 0-42|||mL/s||Standard Deviation|Mean
847598|NCT00527488|Primary|Prostate Volume|The prostatic volume was measured by transrectal ultrasound. The prostatic gland was sonicated from two directions perpendicular to one another resulting in three cursor positions set by the urologist, and the volume automatically calculated.|Day 0-42|||mL||Standard Deviation|Mean
847599|NCT00527488|Primary|Prostate Specific Antigen (PSA) Concentration||Day 0-42|||ng/mL||Standard Deviation|Mean
847600|NCT00527488|Primary|Number of Subjects With Testosterone Concentration at or Above the Baseline Interval Concentration|The baseline interval concentration is 0.75 x baseline concentration|Day 0-42|||participants|||Number
847601|NCT00527488|Primary|Number of Subjects With Testosterone Concentration ≤0.5 ng/mL||Day 0-42|||participants|||Number
847602|NCT00527488|Primary|Duration of Testosterone Concentration Below 0.5 ng/mL|The time from when the testosterone concentration falls below 0.5 ng/mL until it returns above that level|Day 0-42|||Days||Full Range|Median
847603|NCT00527488|Primary|Time of Minimal Value of Testosterone (Tnadir)|The time point when the lowest testosterone concentration was measured|Day 0-42|||Days||Standard Deviation|Mean
847604|NCT00527488|Primary|Minimal Value of Testosterone (Cnadir)|The lowest concentration of testosterone measured within the time frame|Day 0-42|||ng/mL||Standard Deviation|Mean
847605|NCT00527488|Primary|Time of Testosterone Concentration Below Baseline Interval|The time from when the testosterone concentration falls below the baseline interval limit (i.e. 0.75 x baseline concentration) until it returns above this limit|Day 0-42|||Days||Standard Deviation|Mean
847606|NCT00527488|Secondary|Pharmacokinetic Parameters of Degarelix: AUCt|Area under the time-concentration curve (AUCt) was calculated by non-compartmental methods based on data up to Day 42|0-42 Days|||ng*day/mL||Standard Deviation|Mean
847607|NCT00527488|Primary|Testosterone Area Below Baseline Interval|The area of the testosterone concentration (ng/mL) vs. time (days) curve that is below the baseline interval concentration( i.e. 0.75 x baseline concentration)|0-42 Days|||ng*days/mL||Standard Deviation|Mean
847608|NCT00526890|Primary|Incidence of Grade 3-4 Myelosuppression||During study treatment, up to 6 weeks|Patients Treated with Study Therapy||percentage of participants||95% Confidence Interval|Number
847609|NCT00526890|Secondary|Correlation of Selenium Levels With Degree of Observed Adverse Events|Mann-Whitney-Wilcoxon test was used to test the correlation between selenium levels and serious adverse events. There was no significant correlation between selenium levels and serious adverse events (P=0.3149)|Pre-treatment and every week for 6 weeks prior to chemotherapy.||||||
847610|NCT00526890|Secondary|Overall Survival||Post-treatment follow-up every 3 months x4, then per institute standard of practice every 6 months for 2 years, then yearly therafter|Patients treated with study therapy||months||95% Confidence Interval|Median
847611|NCT00526890|Secondary|Failure-free Survival||Post-treatment follow-up every 3 months x4, then per institute standard of practice every 6 months for 2 years, then yearly therafter.|Patients treated with study therapy||months||95% Confidence Interval|Median
847612|NCT00526890|Secondary|Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|1 month post-treatment, then q 3 months x 4|||percentage of patients||95% Confidence Interval|Number
847620|NCT00500682|Primary|Composite of Dialysis Initiation, Kidney Transplantation, and Serum Creatinine Doubling. Number of Participants Meeting the Criteria Are Reported.||Beyond Week 48, a 12-week visit cycle continued until the end of the study or until individual patients reached an endpoint|ITT (censored at last contact)||participants|||Number
847621|NCT00501046|Secondary|Vitamins and Folate Levels||approximately 42 months||||||
847622|NCT00501046|Secondary|The Development of a Component of a Quadruple Composite Endpoint (Initiation of Dialysis, Kidney Transplant, Doubling of sCr, or Death), Other Measures of Renal Function and (QOL: Exploratory)||approximately 42 months||||||
847623|NCT00501046|Primary|Safety and Tolerability||approximately 42 months||||||
847624|NCT00501046|Primary|Composite of Dialysis Initiation, Kidney Transplantation, and Serum Creatinine Doubling. Number of Participants Meeting the Criteria Are Reported.||Beyond Week 48, a 12-week visit cycle continued until the end of the study or until individual patients reached an endpoint|ITT (censored at last contact)||participants|||Number
847625|NCT00498628|Secondary|Quality of Life Score|Quality of Life SF - 12|Week 12||||||
847626|NCT00498628|Secondary|Sleep Quality Score|Pittsburgh Sleep Quality Index|Weeks 4, 8 and 12||||||
847627|NCT00498628|Secondary|Anxiety Score|HAM-A|Weeks 4, 6, 8, 10 and 12||||||
847628|NCT00498628|Secondary|Depression Score|MADRS|Week 4, 6, 8, 10, and 12||||||
847629|NCT00498628|Secondary|Craving Score|PACS|Week 4, 6, 8, 10, 12||||||
847630|NCT00498628|Secondary|Drinking Consequences Score|DrInc Score|Weeks 6 and 12||||||
847631|NCT00498628|Secondary|Percent Subjects With no Heavy Drinking Day||3-11||||||
847632|NCT00498628|Secondary|Percent Subjects Abstinent||3-11||||||
847633|NCT00498628|Secondary|Percent Very Heavy Drinking Day||3-11||||||
847634|NCT00498628|Secondary|Drinks Per Day||3-11||||||
847635|NCT00498628|Secondary|Drinks Per Drinking Day||3-11||||||
847636|NCT00498628|Secondary|Percent Days Abstinent||3-11||||||
847637|NCT00498628|Primary|Percent Heavy Drinking Days|A heavy drinking day is defined as 5 or more drinks for men and 4 or more drinks for women during a 24 hour period.|Weeks 3 - 11|Intention to Treat||percentage of heavy drinking days||Standard Error|Least Squares Mean
847638|NCT00496769|Secondary|Event Rate of All-cause Death; Net Clinical Benefit-Composite of Stroke, Systemic Embolism, Myocardial Infarction, Vascular Death, and Major Bleeding; and Vascular Death|Event rate=percent of participants with an event divided by the total participants in the arm.|Randomization to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy)|Participants who received at least 1 dose of study drug.||Percentage of events per year|||Number
847639|NCT00496769|Secondary|Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Abnormality (Continued)|ULN=upper limit of normal; LLN=lower limit ofnormal; BL=baseline. Creatine kinase (U/L), high:>5*ULN; protein, total(g/L):low if <0.90*BL when BL<LLN or <LLN when B >ULN or <0.90*LLN when BL is missing or LLN≤BL≤ULN, high if >1.10*BL if BL>ULN or >ULN when BL<LLN or >1.10*ULN if BL missing or LLN≤BL≤ULN.Protein,total(g/L): low if <0.90*BL if BL<LLN or <LLN if BL>ULN or <0.90*LLN if BL missing or LLN≤BL≤ULN, high if >1.10*BL if BL>ULN or >ULN if BL<LLN or >1.10*ULN if BL or LLN≤BL≤ULN; glucose, serum fasting (mg/dL): low if <0.8*BL if BL<LLN or <LLN when BL>ULN or <0.8*LLN when BL missing or LLN≤BL≤ULN, high if >2*BL when BL>ULN or >ULN when BL<LLN or >1.5*ULN if BL missing or LLN≤BL≤ULN; uric acid (mg/dL), high: >2*BL and BL>ULN or>1.5*ULN when BL missing or BL≤ULN; glucose, urine, high; protein, urine, high; blood, urine, high; leukocyte esterase, urine, high; RBC count, urine (Hpf), high; WBC count, urine (Hpf), high: ≥2 if BL=missing,=0 or =0.5 or if ≥3 if BL=1, or if ≥4 and BL≥2.|First dose of study drug (Day 1) to 30 days after last dose of blinded study drug|Participants who received at least 1 dose of study drug. n=number evaluable||Participants|||Number
847640|NCT00496769|Secondary|Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Abnormality (Continued)|LLN=lower limit of normal; ULN=upper limit of normal; BL=baseline. Sodium, serum (mEq/L):low if <0.95*BL and BL<LLN or <LLN and BL>ULN or <0.95*LLN when BL missing or LLN ≤BL≤ULN, high if >1.05*BL and BL>ULN or >ULN and BL<LLN or >1.05*ULN when BL missing or LLN≤BL≤ULN; potassium(mEq/L):low if <0.90*BL and BL<LLN or <LLN and BL>ULN or <0.90*LLN if BL missing or LLN≤BL≤ULN, high if >1.10*BL and BL>ULN or>ULN and BL<LLN or >1.10*ULN when BL missing or LLN≤BL≤ULN; chloride(mEq/L):low if <0.90*BL and BL<LLN or <LLN and BL>ULN or <0.90*LLN if BL missing or LLN≤BL ≤ULN, high if >1.10*BL and BL>ULN or >ULN and BL<LLN or >1.10* ULN if BL missing or LLN≤BL≤ULN; calcium(mg/dL):low if <0.75*BL and BL<LLN or <LLN and BL>ULN or <0.80*LLN if BL missing or LLN≤BL≤ULN, high if >1.25*BL and BL>ULN or >ULN if BL<LLN or >1.20*ULN if BL missing or LLN≤BL≤ULN ; bicarbonate(mEq/L):low if <0.75*BL when BL<LLN or <LLN when BL>ULN or <0.75*LLN if BL missing or LLN≤BL≤ULN, high if >1.25*BL when BL>ULN or >ULN|First dose of study drug (Day 1) to 30 days after last dose of blinded study drug|Participants who received at least 1 dose of study drug. n=number evaluable||Participants|||Number
847641|NCT00496769|Secondary|Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Abnormality|BL=baseline, LLN=lower limit of normal, ULN=upper limit of normal. Hemoglobin (g/dL), low: BL>2 or value ≤8; hematocrit(%), low: <0.75*BL; erythrocytes (*10^6 cells/μL), low: <0.75*BL; platelet count (*10^9 cells/L),low: <100*10^9 cells/L; leukocytes (*10^3 cells/μL), low if <0.8*BL and BL<LLN or <LLN and BL >ULN or <0.75*LLN when BL is missing or LLN ≤BL≤ ULN, high if >1.2*BL and BL>ULN or >ULN when BL and BL<LLN or >1.25*ULN when BL is missing or LLN≤BL≤ULN; neutrophils (absolute), low: <1.0*10^3 cells/μL; eosinophils (absolute), high: >0.750*10^3 cells/μL; basophils (absolute), high: >0.4*10^3 cells/μL; monocytes (absolute), high: 2*10^3 cells/μL; lymphocytes (absolute), low if <0.75*10^3 cells/μL, high if >7.50*10^3 cells/μL; ALP (U/L), high: 2*ULN; AST (U/L), high: 3*ULN; AST (U/L), high: 3*ULN; bilirubin, total (mg/dL), high: >2*ULN; bilirubin, direct (mg/dL), high: 1.5*ULN; BUN (mg/dL), high:>2*ULN; creatinine (mg/dL), high: >1.5*ULN.|First dose of study drug (Day 1) to 30 days after last dose of blinded study drug|Participants who received at least 1 dose of study drug. n=number evaluable||Participants|||Number
847642|NCT00496769|Primary|Rate of Unrefuted Bleeding From First Dose of Double-blind Study Drug to First Occurence of Unrefuted Bleeding During the Double-blind Treatment Period|Event rate=percent of participants with an event divided by the total participants in the arm.|Day 1 to first bleeding event up to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy)|Participants who received at least 1 dose of study drug.||Percentage of events per year|||Number
847643|NCT00496769|Secondary|Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs), Bleeding AEs, Discontinuations Due to AEs, and Death as Outcome|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|First dose of study drug (Day 1) to 30 days after last dose of blinded study drug|Participants who received at least 1 dose of study drug.||Participants|||Number
847644|NCT00496769|Secondary|Event Rates for Major Bleeding, Major or Clinically Relevant Nonmajor (CNRM) Bleeding, and All Bleeding in the Double-blind Period|Event rate=percent of participants with an event divided by the total participants in the arm.|First dose of study drug (Day 1) to the earlier of a patient's discontinuation of double-blind study drug or the attainment of at least 226 primary efficacy events up to May 28, 2010|Participants who received at least 1 dose of study drug.||Percentage of events per year|||Number
847645|NCT00496769|Secondary|Event Rates of Major Vascular Events (Stroke/Systemic Embolism, Myocardial Infarction, Death) in the Intended-treatment Period|Event rate=percent of participants with an event divided by the total participants in the arm.|Randomization to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy)|Participants who received at least 1 dose of study drug||Percentage of events per year|||Number
847646|NCT00496769|Primary|Event Rate of Stroke/Systemic Embolism During the Intended-treatment Period|Event rate=percent of participants with an event divided by the total participants in the arm. Intended-treatment period=date of randomization to the efficacy cutoff date, which was to be the date on which at least 226 unrefuted original primary efficacy events occurred (date revised to May 28, 2010 following cessation of study for superior efficacy.)|Randomization to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy)|Participants who received at least 1 dose of study drug.||Percentage of events|||Number
847647|NCT00488774|Secondary|Number of Participants With Clinical Remission|Clinical remission is defined as a Mayo score of less than or equal to 2, with no individual sub-score greater than 1. The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and a physician’s global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12.|Week 6|The efficay analysis population included all the participants who were randomly assigned to receive study medication. Here ‘N’ signifies participants who were evaluated for this outcome measure.||Participants|||Number
847648|NCT00488774|Primary|Number of Participants With Clinical Response|Clinical response is defined as decrease from baseline in Mayo score by greater than or equal to 30 percent and greater than or equal to 3, with either a decrease from baseline in rectal bleeding sub-score of greater than or equal to 1 or a rectal bleeding sub-score of 0 or 1. The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and a physician’s global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12.|Week 6|The efficay analysis population included all the participants who were randomly assigned to receive study medication. Here ‘N’ signifies participants who were evaluated for this outcome measure.||Participants|||Number
847649|NCT00488683|Secondary|Serogroup A, C, W-135 and Y Specific IgG Concentrations After MenACWY-CRM Primary Vaccination|To assess the kinetics of serogroup A, C, W-135 and Y specific IgG concentrations, the geometric mean concentration was measured on day 0, 7, 14, 30, 49, 90, and 120 following vaccination with MenACWY-CRM vaccination at month 4 of the study.|Day 0, 7, 14, 30, 49, 90,120 after MenACWY-CRM vaccination at month 4|This outcome was assessed in Group 1 PP set population.||µg/mL||95% Confidence Interval|Geometric Mean
847650|NCT00488683|Secondary|Increase in Serogroup A, C, W-135 and Y Specific IgG Concentrations Before and 1 Month After MenACWY-CRM Booster Vaccination at 12 Months of Age Administered Concomitantly With Pneumococcal Conjugate Vaccine or Alone|Serogroup A, C, W-135 and Y specific IgG concentrations were measured before and one month after MenACWY-CRM booster vaccination by ELISA.|Before and one month after booster vaccination|Analysis was performed on the PP dataset of booster vaccination.||µg/mL||95% Confidence Interval|Mean
847651|NCT00488683|Secondary|Percentage of Subjects Who Reported Solicited Systemic Reactions After MenACWY-CRM and PCV Vaccination at 12 Months of Age|Safety was assessed as the percentage of subjects who reported systemic reactions during 7-day follow-up period after MenACWY-CRM and PCV vaccination at 12 months of age.|7 days post 12 months vaccination|The analysis was performed on safety after booster population (safety population who received vaccination at 12 months of age).||Percentage of subjects|||Number
847652|NCT00488683|Secondary|Percentage of Subjects Who Reported Injection Site Local Reactions After MenACWY-CRM and PCV Vaccinations at 12 Months of Age|Safety was assessed as the percentage of subjects who reported injection site local reactions during 7-day follow-up period after MenACWY-CRM and PCV vaccinations at 12 months of age.|7 days post 12 month vaccination|The analysis was performed on safety after booster population (safety population who received vaccination at 12 months of age).||Percentage of subjects|||Number
847653|NCT00488683|Secondary|Percentage of Subjects Who Reported Solicited Systemic Reactions After MenACWY-CRM and Routine Infants Primary Vaccinations|Safety was assessed as the percentage of subjects who reported systemic reactions during 7-day follow-up period after MenACWY-CRM (2 and 4 months) and routine infant primary vaccinations (2, 3 and 4 months).|7 days post vaccination at 2, 3, and 4 months of age|The analysis was performed on the safety population.||Percentage of subjects|||Number
847654|NCT00488683|Secondary|Percentage of Subjects Who Reported Injection Site Local Reactions After Each MenACWY-CRM and Routine Infant Vaccinations.|Safety was assessed as the percentage of subjects who reported injection site local reactions during 7-day follow-up period after each MenACWY-CRM and routine infant vaccination administered as a primary course of vaccination.|7 days post each MenACWY-CRM and routine infant vaccination|The analysis was performed on the Safety Population.||Percentage of subjects|||Number
847676|NCT00474526|Secondary|Geometric Mean hSBA Titers at 1 Month After 1st (LA2) or 2nd (LA4) Toddler MenACWY Vaccination - LA Subjects|Immunogenicity as measured by Serum bactericidal activity using human complement (hSBA) GMTs, directed against N. meningitidis serogroups A, C, W and Y.|12 or 15 months of age (one month post 1st or 2nd toddler vaccination)|The analysis was done on per protocol population||Titers||95% Confidence Interval|Geometric Mean
847655|NCT00488683|Secondary|Linear Regression Coefficients (1) Between Serogroup A, C, W-135 and Y Memory B Cells at 5 Months and Rise in hSBA Titers, (2) Between Serogroup A, C, W-135 and Y Memory B Cells at 5 Months and Rise in IgG, After Third Dose of MenACWY-CRM at 12 Months|"The rise in serogroup-specific hSBA and IgG was calculated by pre/post third dose geometric mean ratios, calculated by the difference in the log10 of the concentrations/titers measured at 13 months to the log10 of the concentrations at 12 months: i.e. rise = log10(x) at 13 months minus log10(x) at 12 months where x is the serogroup specific IgG or SBA titers.
Linear regression analysis between memory B cells at 5 months of age and rise in hSBA titers or IgG at 12 months of age was performed with and without inclusion of demographic factors (subject's household smoking status, number of older children living in subject's household, attendance at daycare and total duration of breast feeding) in the model."|1 month post primary vaccination (B cells) and 12 months (hSBA titers and IgG)|Analysis was performed on the PP dataset after booster vaccination.|||||Number
847656|NCT00488683|Secondary|Linear Regression Coefficients (1) Between Serogroup A, C, W-135 and Y Memory B at 5 Months and hSBA Titers at 12 Months, (2) Between Serogroup A, C, W-135 and Y Memory B at 5 Months and IgG at 12 Months, After a 2-Dose Primary Course of MenACWY-CRM|Linear regression analysis between memory B cells at 5 months of age and hSBA titers and IgG at 12 months of age was performed with and without inclusion of demographic factors (subject's household smoking status, number of older children living in subject's household, attendance at daycare and total duration of breast feeding) in the model.|1 month post primary vaccination (B cells) and 12 months (hSBA titers and IgG)|Analysis was performed on the PP dataset of persistence population.|||||Number
847657|NCT00488683|Secondary|Correlation and Linear Regression Coefficients Between Serogroup A, C, W-135 and Y Specific Memory B Cells 1 Month After MenACWY-CRM Primary Vaccination and IgG Concentration at Day 1 in the Serum of Mothers of Infants|The serogroup A, C, W-135 and Y specific IgG concentrations were measured in the serum of mothers at the time of their enrollment into the study (Day 1) by ELISA.|Day 1 (IgG) and one month after primary vaccination (B cells)|Analysis was performed on the PP primary population.|||||Number
847658|NCT00488683|Secondary|Serogroup A, C, W-135 and Y Specific hSBA Titers After MenACWY-CRM Primary Vaccination|To assess the kinetics of serogroup A, C, W-135 and Y specific hSBA titers, the geometric mean titer was measured on day 0, 7, 14, 30, 49, 90, and 120 following vaccination with MenACWY-CRM vaccination at month 4 of the study.|Day 0, 7, 14, 30, 49, 90,120 after MenACWY-CRM vaccination at month 4|This outcome was assessed in Group 1 PP set population.||titers||95% Confidence Interval|Geometric Mean
847659|NCT00488683|Secondary|Serogroup A, C, W-135 and Y Specific Memory B Cells and Plasma B Cells After MenACWY-CRM Primary Vaccination|"To assess the kinetics of serogroup A, C, W-135 and Y specific memory B cells, plasma B cells and IgG concentrations were measured on days 0, 7, 14, 49, 90, and 120 following vaccination with MenACWY-CRM vaccination at month 4 of the study.
The memory B cell response at different timepoint was defined as the mean number of meningococcal serogroup A, C, W-135 and Y specific memory B cells, measured in vitro by ELISpot assay per 2x100000 lymphocytes obtained from culture (LOC) of peripheral blood mononuclear cells (PBMC) circulating in blood incubated for 5.5 days in the presence of polyclonal B cell activators in vitro.
The B plasma cell response at each time point was defined as the mean number of cells secreting antibodies specific for meningococcal serogroup A, C, W-135 and Y, measured by ELISpot assay, per 2x100000 PBMC."|Day 0, 7, 14, 49, 90, and 120 after MenACWY-CRM vaccination at month 4|This outcome was assessed in Group 1 PP set population.||per 2x100000 cells||Standard Deviation|Mean
847660|NCT00488683|Secondary|Serogroups A, C, W-135 and Y Specific Memory B Cell Response in Children Lacking a hSBA Titer of ≥1:8 One Month After MenACWY-CRM Primary Vaccination|The memory B cell response in children lacking a hSBA titer ≥1:8 one month after MenACWY-CRM primary vaccination was calculated as the mean number of meningococcal serogroup specific memory B cells, measured by ELISpot assay per 2x100000 LOC.|One month after primary vaccination|Analysis was performed on the PP primary population and PP persistence population, subjects lacking hSBA ≥1:8 one month after primary vaccination.||B cells per 2x100000 lymphocytes||Standard Deviation|Mean
847661|NCT00488683|Secondary|Increase in Serogroup A, C, W-135 and Y Specific hSBA Titers Before and 1 Month After MenACWY-CRM Booster Vaccination at 12 Months of Age Administered Concomitantly With Pneumococcal Conjugate Vaccine or Alone|hSBA GMTs were measured before and one month after MenACWY-CRM booster vaccination at 12 months of age.|Before and one month after booster vaccination|Analysis was performed on the PP dataset of booster vaccination.||titers||95% Confidence Interval|Mean
847662|NCT00488683|Secondary|Increase in Serogroup A, C, W-135 and Y Specific Memory B Cells Before and 1 Month After MenACWY-CRM Booster Vaccination at 12 Months of Age Administered Concomitantly With Pneumococcal Conjugate Vaccine or Alone|Memory B cell response before and one month after MenACWY-CRM booster vaccination at 12 months of age was measured as mean number of meningococcal serogroup A, C, W-135 and Y specific memory B cells by ELISpot assay per 2x100000 LOC.|Before and one month after booster vaccination|Analysis was performed on the PP dataset of booster vaccination.||B cells per 2x100000 lymphocytes||Standard Deviation|Mean
847663|NCT00488683|Secondary|CRM197 Specific Memory B Cells 1 Month After Primary Vaccination and at 12 Months of Age and One Month After MenACWY-CRM Third Vaccination|"CRM197 specific memory B cell response at each time point was measured as mean number of CRM197 specific memory B cells by ELISpot assay per 2x100000 LOC.
CRM197 specific IgG concentration was measured by ELISA at 12 months of age and one month after MenACWY-CRM booster vaccination."|5 months (B cells), 12 months and 13 months (B cells and IgG) of age|Analysis was done on the PP primary population and PP booster population.|||||Number
847664|NCT00488683|Secondary|Memory B Cells 1 Month After Primary Vaccination and 1 Week After Third Vaccination by Serogroup A, C, W-135 and Y|"Memory B cell response at 1 month after primary vaccination and at 1 week after third vaccination was measured as mean number of meningococcal serogroup specific memory B cells by ELISpot assay per 2x100000 LOC.
Plasma B cell response at 1 week after vaccination was measured as the mean number of cells secreting antibodies specific for meningococcal serogroup A, C, W-135 and Y, measured by ELISpot assay, per 2x100000 PBMC.
Serogroup A, C, W-135 and Y specific IgG were measured by ELISA and hSBA GMTs were measured at 1 week after third vaccination."|One month after primary vaccination and 1 week after third vaccination|This outcome was assessed in Group 3 subjects only as they provided a blood draw at 1 week following the MenACWY-CRM booster vaccination. Analysis was performed on PP booster population.|||||Number
847665|NCT00488683|Secondary|Memory B Cells 1 Month After Primary Vaccination and Rise From Pre-third Dose to 1 Month After Third Dose of MenACWY-CRM Vaccination|"Memory B cell response at 1 month after MenACWY-CRM primary and third (booster) vaccination was measured as mean number of meningococcal serogroup specific memory B cells by ELISpot assay per 2x100000 LOC.
The serogroup A, C, W-135 and Y specific IgG concentrations at 1 month after MenACWY-CRM booster were measured by ELISA.
hSBA GMTs were measured by hSBA assay one month after MenACWY-CRM booster vaccination.
The rise in serogroup specific IgG, memory B cells and hSBA was calculated by pre/post third dose geometric mean ratios, calculated by the difference in the log10 of the concentrations/titers measured at 13 months to the log10 of the concentrations at 12 months: i.e. rise = log10(x) at 13 months minus log10(x)at 12 months where x is the serogroup specific IgG or memory B cell concentrations or SBA titers."|1 month after primary and pre-third and 1 month after third vaccination|"Values from Group 1 were analyzed separately. Values from Groups 2 and 3 were combined for the analysis. Groups 2 and 3 received PCV at 12 months while Group 1 received PCV at 13 months.
Analysis was performed on PP booster population."|||||Number
847666|NCT00488683|Secondary|Memory B Cells Per 2x100000 by Serogroup A,C, W-135 and Y at One Month After Primary MenACWY-CRM Vaccination and Third MenACWY-CRM Vaccination|"Memory B cell response at 1 month after MenACWY-CRM primary and booster vaccinations was measured as mean number of meningococcal serogroup specific memory B cells by ELISpot assay per 2x100000 LOC.
hSBA GMTs for the serogroup A, C, W-135 and Y were measured one month after the third MenACWY-CRM vaccination.
The meningococcal serogroup A, C, W-135 and Y specific IgG concentrations one month after third MenACWY-CRM vaccination were measured by ELISA."|1 month after primary vaccination and 1 month after third vaccination|"Values from Group 1 were analyzed separately. Values from Groups 2 and 3 were combined for the analysis. Groups 2 and 3 received PCV at 12 months while Group 1 received PCV at 13 months.
Analysis was performed on PP booster population."|||||Number
847667|NCT00488683|Secondary|Memory B Cells by Serogroup A, C, W-135 and Y|"Memory B cell response at 1 month after primary vaccination and immediately before third dose at 12 months of age was measured as mean number of meningococcal serogroup specific memory B cells by ELISpot assay per 2x100000 LOC.
The meningococcal serogroup A, C, W-135 and Y specific IgG concentrations immediately before third dose at 12 months of age were measured by ELISA."|1 month after primary vaccination and immediately before third dose|Analysis was performed on PP dataset of persistence population.|||||Number
847668|NCT00488683|Primary|Summary of Memory B Cells Per 2 x 105 LOC by Serogroup A, C, W-135 and Y|"The memory B cell response at one month after primary vaccinations (5 months of age) was defined as the mean number of meningococcal serogroup A, C, W-135 and Y specific memory B cells, measured in vitro by ELISpot assay per 2x100000 lymphocytes obtained from culture (LOC) of peripheral blood mononuclear cells (PBMC) circulating in blood incubated for 5.5 days in the presence of polyclonal B cell activators.
Serogroup A, C, W-135 and Y geometric mean titers (GMTs) were measured by serum bactericidal assay using human complement (hSBA) at 12 months of age (before third dose).
Correlation and linear regression coefficients were determined between memory B cells at 1 month after primary vaccinations with MenACWY-CRM (5 months of age) and hSBA titers at 12 months of age (before third dose) for the serogroups A, C, W-135 and Y."|1 month after primary vaccination and immediately before third dose at 12 months of age|Analysis was performed on per-protocol (PP) dataset of primary vaccination, i.e. subjects who received all the relevant doses of vaccine correctly; provided evaluable blood samples at the relevant time points; and had no major protocol violation as defined prior to analysis.||B cells per 2x100000 lymphocytes||Standard Deviation|Mean
847669|NCT00487539|Secondary|Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 6|The IBDQ is used to measure disease specific quality of life on a 32 Likert-scaled items questionnaire. The IBDQ scale contains 4 component subscales: bowel symptoms, systemic symptoms, emotional function and social function with scores ranging from 10 to 70, 5 to 35, 12 to 84 and 5 to 35 respectively and the total score ranges from 32 to 224. Higher scores indicate better health related quality of life.|Baseline to Week 6|Efficacy analysis population included all the participants who were randomly assigned to the study after the dose selection. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||Units on a Scale||Standard Deviation|Mean
847670|NCT00487539|Secondary|Number of Participants With Mucosal Healing at Week 6|Mucosal healing is determined from the endoscopy sub-score of the Mayo score. Mucosal healing is defined as an endoscopy sub-score of 0 or 1. Higher score indicates higher severity of disease. Endoscopy sub-score ranges from 0 (normal or inactive disease) to 3 (severe disease; spontaneous bleeding and ulceration).|Week 6|Efficacy analysis population included all the participants who were randomly assigned to the study after the dose selection.||Participants|||Number
847671|NCT00487539|Secondary|Number of Participants With Clinical Remission at Week 6|Clinical remission is defined as a Mayo score of less than or equal to 2, with no individual sub-score greater than 1. The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and physician’s global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12.|Week 6|Efficacy analysis population included all the participants who were randomly assigned to the study after the dose selection.||Participants|||Number
847672|NCT00487539|Primary|Number of Participants With Clinical Response at Week 6|Clinical response is defined as decrease from baseline in Mayo score by greater than or equal to 30 percent and greater than or equal to 3, with either a decrease from baseline in rectal bleeding sub-score of greater than or equal to 1 or a rectal bleeding sub-score of 0 or 1. The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and physician’s global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12.|Baseline, Week 6|Efficacy analysis population included all the participants who were randomly assigned to the study after the dose selection.||Participants|||Number
847677|NCT00474526|Secondary|Percentage of Subjects With hSBA ≥1:8 at 1 Month After 1st (LA2) or 2nd (LA4) Toddler MenACWY Vaccination - LA Subjects|Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:8, directed against N.meningitidis serogroups A, C, W and Y.|12 or 15 months of age (one month post 1st or 2nd toddler vaccination)|The analysis was done on per protocol population||Percentages of subjects||95% Confidence Interval|Number
847678|NCT00474526|Secondary|Seroresponse Rates to DTaP and Hib Antigens at 1 Month After Toddler Vaccination - LA Subjects|Immunogenicity as measured by Percentage of Subjects with predefined seroprotective antibody titers against DTaP and Hib Antigens|17 months of age (one month post-toddler vaccination)|Per Protocol||Percentages of subjects||95% Confidence Interval|Number
847679|NCT00474526|Secondary|Geometric Mean Concentrations or Titers of DTaP and Hib Antigens at 1 Month After Toddler Vaccination - LA Subjects|Immunogenicity as measured by antibody GMCs/GMTs, directed against DTaP and Hib Antigens|17 months of age (one month post-toddler vaccination)|Per Protocol||Titers||95% Confidence Interval|Geometric Mean
847680|NCT00474526|Secondary|Percentage of Subjects With Pneumococcal Antibody Concentration ≥1.0 μg/mL at 1 Month After Toddler Vaccination - LA Subjects|Immunogenicity as measured by Percentage of Subjects with Pneumococcal Antibody GMCs ≥1.0 μg/mL directed against pneumococcal antigens PnC 4, PnC 6B, PnC 9V, PnC 14, PnC 18C, PnC 19F and PnC 23F|13 months of age (one month post-toddler vaccination)|Per Protocol||Percentages of subjects||95% Confidence Interval|Number
847681|NCT00474526|Secondary|Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination – LA Subjects|Immunogenicity as measured by antibody GMTs, directed against pneumococcal antigens PnC 4, PnC 6B, PnC 9V, PnC 14, PnC 18C, PnC 19F and PnC 23F.|13 months of age (one month post-toddler vaccination)|Per Protocol||Concentrations (μg/mL)||95% Confidence Interval|Geometric Mean
847682|NCT00474526|Secondary|Percentage of Subjects With Pneumococcal Antibody GMCs ≥1.0 μg/mL at 1 Month After Toddler Vaccination - US Subjects|Immunogenicity as measured by Percentage of Subjects with Pneumococcal Antibody GMCs ≥1.0 μg/mL directed against pneumococcal antigens PnC 4, PnC 6B, PnC 9V, PnC 14, PnC 18C, PnC 19F and PnC 23F.|13 months of age (one month post-toddler vaccination)|Per Protocol||Percentages of subjects||95% Confidence Interval|Number
847683|NCT00474526|Secondary|Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - US Subjects|Immunogenicity as measured by antibody GMTs, directed against pneumococcal antigens PnC 4, PnC 6B, PnC 9V, PnC 14, PnC 18C, PnC 19F and PnC 23F.|13 months of age (one month post-toddler vaccination)|Per Protocol||Titers||95% Confidence Interval|Geometric Mean
847684|NCT00474526|Secondary|Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - LA Subjects|Immunogenicity as measured by Serum bactericidal activity using human complement (hSBA) GMTs, directed against N. meningitidis serogroups A, C, W and Y.|13 or 17 Months of Age (one month post-toddler vaccination)|The analysis was done on per protocol population||Titers||95% Confidence Interval|Geometric Mean
847685|NCT00474526|Secondary|Percentage of Subjects With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - LA Subjects|Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:16, directed against N. meningitidis serogroups A, C, W and Y.|13 or 17 Months of Age (one month post-toddler vaccination)|The analysis was done on per protocol population||Percentages of subjects||95% Confidence Interval|Number
847686|NCT00474526|Secondary|Percentage of Subjects (95% CI) With hSBA ≥1:8 at 1 Month After Toddler MenACWY Vaccination - LA Subjects|Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:8, directed against N. meningitidis serogroups A, C, W and Y.|13 or 17 Months of Age (one month post-toddler vaccination)|The analysis was done on per protocol population||Percentages of subjects||95% Confidence Interval|Number
847687|NCT00474526|Secondary|Percentage of Subjects (95% CI) With hSBA ≥1:4 at 1 Month After Toddler MenACWY Vaccination - LA Subjects|Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:4, directed against N. meningitidis serogroups A, C, W and Y.|13 or 17 Months of Age (one month post-toddler vaccination)|The analysis was done on per protocol population||Percentages of subjects||95% Confidence Interval|Number
847688|NCT00474526|Secondary|Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - US Subjects|Immunogenicity as measured by Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y; comparison of four doses of MenACWY-CRM at 2, 4, and 6 and 12 months of age versus a single dose at 12 months of age.|13 months of age (one month post-toddler vaccination)|The analysis was done on per protocol population||Titers||95% Confidence Interval|Geometric Mean
847689|NCT00474526|Secondary|Percentage of Subjects (95% CI) With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - US Subjects|Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:16 , directed against N.meningitidis serogroups A, C, W and Y.|13 months of age (one month post-toddler vaccination)|The analysis was done on per protocol population||Percentages of subjects||95% Confidence Interval|Number
847690|NCT00474526|Secondary|Percentage of Subjects (95% CI) With hSBA ≥ 1:8 at 1 Month After Toddler MenACWY Vaccination - US Subjects|Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:8 , directed against N.meningitidis serogroups A, C, W and Y.|13 months of age (one month post-toddler vaccination)|The analysis was done on per protocol population||Percentages of subjects||95% Confidence Interval|Number
847691|NCT00474526|Secondary|Percentage of Subjects (95% CI) With hSBA ≥ 1:4 at 1 Month After Toddler MenACWY Vaccination - US Subjects|Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:4 , directed against N.meningitidis serogroups A, C, W and Y.|13 months of age (one month post-toddler vaccination)|The analysis was done on per protocol population||Percentages of subjects||95% Confidence Interval|Number
847692|NCT00474526|Secondary|Persistence Antibodies Geometric Mean Titers - LA Subjects|Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y was measured at 12 or 16 Months of Age.|12 or 16 Months of Age (one month pre-toddler vaccination)|The analysis was done on per protocol population||Titers||95% Confidence Interval|Geometric Mean
847976|NCT00354172|Secondary|Number of Participants (Patients) With Chronic Graft-Versus-Host Disease|The chronic form of graft-versus-host-disease (cGVHD) normally occurs after 100 days. The appearance of moderate to severe cases of cGVHD adversely influences long-term survival.|Day 100 through 1 Year Post Transplant|||Participants|||Number
847693|NCT00474526|Secondary|Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 or 16 Months of Age- LA Subject|Persistence of Antibodies as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:8, directed against N.meningitidis serogroups A, C, W and Y.|12 or 16 Months of Age (one month pre-toddler vaccination)|The analysis was done on per protocol population||Percentages of subjects||95% Confidence Interval|Number
847694|NCT00474526|Secondary|Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 or 16 Months of Age- LA Subject|Persistence of Antibodies as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:4, directed against N.meningitidis serogroups A, C, W and Y.|12 or 16 Months of Age (one month pre-toddler vaccination)|The analysis was done on per protocol population||Percentages of subjects||95% Confidence Interval|Number
847695|NCT00474526|Secondary|Persistence Antibodies Geometric Mean Titers – US Subject|Geometric Mean hSBA Titers directed against N. meningitides serogroups A, C, W and Y was measured at 12 Months of Age.|12 Months of Age (one month pre-toddler vaccination)|The analysis was done on per protocol population||Titers||95% Confidence Interval|Geometric Mean
847696|NCT00474526|Secondary|Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 Months of Age- US Subject|Persistence of Antibodies as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:8, directed against N.meningitidis serogroups A, C, W and Y.|12 Months of Age (one month pre-toddler vaccination)|"The analysis was done on per protocol population
Per protocol was defined as subjects who:
received all the relevant doses of vaccine correctly
provided evaluable serum samples at the relevant time points
had no major protocol deviation as defined prior to database lock"||Percentages of subjects||95% Confidence Interval|Number
847697|NCT00474526|Secondary|Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 Months of Age- US Subject|Persistence of Antibodies as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:4, directed against N.meningitidis serogroups A, C, W and Y.|12 Months of Age (one month pre-toddler vaccination)|"The analysis was done on per protocol population
Per protocol was defined as subjects who:
received all the relevant doses of vaccine correctly
provided evaluable serum samples at the relevant time points
had no major protocol deviation as defined prior to database lock"||Percentages of subjects||95% Confidence Interval|Number
847698|NCT00474526|Secondary|Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects|Immunogenicity as measured by percentage of subjects with predefined seroprotective antibody titers against DTaP, HBV, Hib, pneumococcal and polio antigens.|7 months of age (one month post-infant series)|Per Protocol||Percentages of subjects||95% Confidence Interval|Number
847699|NCT00474526|Secondary|Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects|Immunogenicity as measured by antibody GMCs / GMTs directed against DTaP, HBV, Hib, pneumococcal and polio antigens.|7 months of age (one month post-infant series)|Per Protocol||Titers||95% Confidence Interval|Geometric Mean
847700|NCT00474526|Secondary|Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects|Immunogenicity as measured by percentage of subjects with predefined seroprotective antibody titers against DTaP, HBV, Hib, pneumococcal and polio antigens.|7 months of age (one month post-infant series)|Per Protocol||Percentages of subjects||95% Confidence Interval|Number
847701|NCT00474526|Secondary|Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects|Immunogenicity as measured by antibody GMCs / GMTs directed against DTaP, HBV, Hib, pneumococcal and polio antigens.|7 months of age (one month post-infant series)|Per Protocol||Titers||95% Confidence Interval|Geometric Mean
847702|NCT00474526|Secondary|Percentage of Subjects With hSBA Titer >=1:4 - LA Subjects|Immunogenicity as measured by percentage of subjects with hSBA titer >=1:4 directed against N. meningitidis serogroups A, C, W and Y; after two doses of MenACWY at 2 and 6 months (LA1) versus three doses at 2, 4, and 6 months of age (LA3) .|7 months of age (one month post-infant series)|Per protocol population||Percentages of subjects||95% Confidence Interval|Number
847703|NCT00474526|Secondary|Percentage of Subjects With hSBA Titer >=1:8 - LA Subjects|Immunogenicity as measured by percentage of subjects with hSBA titer >=1:8 directed against N. meningitidis serogroups A, C, W and Y; after two doses of MenACWY at 2 and 6 months (LA1) versus three doses at 2, 4, and 6 months of age (LA3) .|7 months of age (one month post-infant series)|Per protocol population||Percentages of subjects||95% Confidence Interval|Number
847704|NCT00474526|Secondary|Percentage of Subjects With hSBA Titer >=1:4 - US Subjects|Immunogenicity as measured by percentage of subjects with hSBA titer >=1:4 directed against N. meningitidis serogroups A, C, W and Y; after three doses of MenACWY at 2, 4, and 6 months of age.|7 months of age (one month post-infant series)|Per Protocol Population||Percentages of subjects||95% Confidence Interval|Number
847705|NCT00474526|Secondary|Percentage of Subjects With hSBA Titer >=1:8 - US Subjects|Immunogenicity as measured by percentage of subjects with hSBA titer >=1:8 directed against N. meningitidis serogroups A, C, W and Y; after three doses of MenACWY at 2, 4, and 6 months of age.|7 months of age (one month post-infant series)|Per Protocol Population||Percentages of subjects||95% Confidence Interval|Number
847706|NCT00474526|Secondary|Geometric Mean hSBA Titers Post-infant Series - LA Subjects|Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y was measured after two doses of MenACWY at 2 and 6 months (LA1) versus three doses at 2, 4, and 6 (LA3) months of age.|7 months of age (one month post-infant series)|Per protocol population||Titer||95% Confidence Interval|Geometric Mean
847707|NCT00474526|Secondary|Geometric Mean hSBA Titers Post-infant Series - US Subjects|Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y was measured after three doses at 2, 4, and 6 months of age.|7 months of age (one month post-infant series)|The analysis was done on per protocol population||Titers||95% Confidence Interval|Geometric Mean
847708|NCT00474526|Secondary|Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination – Infant Series|Solicited local and systemic reactions reported post third vaccination was compared in subjects receiving MenACWY versus Hib Vaccines.|7 days post-vaccination|The population used in analysis was the safety set: The total number of subjects analyzed was less than the safety set due to subject withdrawals. Only subjects who received the third dose in the infant series were included in this analysis.||Subjects|||Number
847709|NCT00474526|Secondary|Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination – Infant Series|Solicited local and systemic reactions reported post second vaccination was compared in subjects receiving MenACWY versus Hib Vaccines.|7 days post-vaccination|The population used in analysis was the safety set: The total number of subjects analyzed was less than the safety set due to subject withdrawals. Only subjects who received the second dose of the infant series vaccination were included in the analysis.||Subjects|||Number
847710|NCT00474526|Secondary|Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination – Infant Series|Solicited local and systemic reactions reported post first vaccination was compared in subjects receiving MenACWY versus Hib Vaccines.|7 days post-vaccination|The population used in analysis was the safety set: The total number of subjects analyzed was less than the safety set due to subject withdrawals.||Subjects|||Number
847711|NCT00474526|Secondary|Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination – Toddler Series|Solicited local and systemic reactions post second vaccination of toddler series at 15 months of age.|7 days post vaccination|The population used in analysis was the safety set: The total number of subjects analyzed was less than the safety set due to subject withdrawals. Only subjects who received the second dose at 15 months were included in this analysis.||Subjects|||Number
847712|NCT00474526|Secondary|Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination – Toddler Series|Solicited local and systemic reactions post first vaccination of toddler series were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines.|7 days post vaccination|The population used in analysis was the safety set: The total number of subjects analyzed was less than the safety set due to subject withdrawals.||Subjects|||Number
847713|NCT00474526|Secondary|Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age|Solicited local and systemic reactions after receiving MenACWY-CRM vaccination at 12 months of age were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines.|7 days after vaccination|The population used in analysis was the safety set: The total number of subjects analyzed was less than the safety set due to subject withdrawals.||Subjects|||Number
847714|NCT00474526|Secondary|Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination – Infant Series|Solicited local and systemic reactions post third vaccination of infant series were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines.|7 days after vaccination|The population used in analysis was the safety set: The total number of subjects analyzed was less than the safety set due to subject withdrawals.||Subjects|||Number
847715|NCT00474526|Primary|Geometric Mean hSBA Titers – US Subjects|Immunogenicity as measured by Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y; comparison of four doses of MenACWY-CRM at 2, 4, and 6 and 12 months of age versus a single dose at 12 months of age.|13 months of age (one month post-toddler vaccination)|The analysis was done on per protocol population||Titers||95% Confidence Interval|Geometric Mean
847716|NCT00474526|Secondary|Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination – Infant Series|Solicited local and systemic reactions post second vaccination of infant series were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines.|7 days after vaccination|The population used in analysis was the safety set: The total number of subjects analyzed was less than the safety set due to subject withdrawals. LA1 and LA 2 groups are not included here as they did not receive MenACWY at 4 months of age.||Subjects|||Number
847717|NCT00474526|Secondary|Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination – Infant Series|Solicited local and systemic reactions post first vaccination of infant series were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines.|7 days after vaccination|The population used in analysis was the safety set Safety population was defined as: all subjects in the exposed population who provided post-baseline safety data. If a subject received an entirely wrong vaccine schedule (e.g., US3 instead of US4), the subject would be analyzed for safety according to the group the subject actually followed.||Subjects|||Number
847718|NCT00474526|Primary|Percentage of Subjects With hSBA Titer >=1:8 - US Subjects|Immunogenicity as measured by percentage of subjects with hSBA titer >=1:8 directed against N. meningitidis serogroups A, C, W and Y; after four doses of MenACWY-CRM at 2, 4, and 6 and 12 months of age|13 months of age (one month post-toddler vaccination)|"The analysis was done on per protocol population
Per protocol was defined as subjects who:
received all the relevant doses of vaccine correctly
provided evaluable serum samples at the relevant time points
had no major protocol deviation as defined prior to database lock"||Percentages of subjects||95% Confidence Interval|Number
847719|NCT00466817|Secondary|Neurological Impairment at 24 Months of Life, Utilizing the Bayley Scales of Infant and Toddler Development (Motor Composite Score).|Motor composite score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Composite Scores, the range of scores is between 40 (very poor motor skills) and 160 (excellent motor skills), with the average motor skills score for a child (age adjusted) is 100 with standard deviation of 15.|24 Months after enrollment|only subjects that were randomized and had the 24 month Bayleys exam motor composite score were analyzed||units on a scale||Standard Error|Mean
847720|NCT00466817|Secondary|Neurological Impairment at 24 Months of Life, Utilizing the Bayley Scales of Infant and Toddler Development (Gross Motor Scaled Score).|Gross motor scaled score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring is between 1 (very poor gross motor skills) and 19 (excellent gross motor skills), with the average gross motor skills score for a child (age adjusted) is 10 with standard deviation of 3.|24 Months after enrollment.|only subjects that were randomized and had the 24 month Bayleys exam gross motor score were analyzed||units on a scale||Standard Error|Mean
847721|NCT00466817|Secondary|Neurological Impairment at 24 Months, Utilizing the Bayley Scales of Infant and Toddler Development (Fine Motor Scaled Score).|Fine motor scaled score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Scaled Scores, the range of scores is between 1 (very poor fine motor skills) and 19 (excellent fine motor skills), with the average fine motor skills score for a child (age adjusted) is 10 with standard deviation of 3.|24 Months after enrollment|only subjects that were randomized and had the 24 month Bayleys exam fine motor were analyzed||units on a scale||Standard Error|Mean
847722|NCT00466817|Secondary|Neurologic Impairment at 24 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Language Composite Score).|Language Composite Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Composite Scores, the range of scores is between 40 (very poor language skills) and 160 (excellent language skills), with the average language skills score for a child (age adjusted) is 100 with standard deviation of 15.|24 Months after enrollment|only subjects that were randomized and had the 24 month Bayleys exam language composite score were analyzed||units on a scale||Standard Error|Mean
847723|NCT00466817|Secondary|Neurological Impairment at 24 Months of Life, Utilizing the Bayley Scales of Infant and Toddler Development (Expressive Communication Scaled Score).|Expressive Communication Scaled Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Scaled Scores, the range of scores is between 1 (very poor expressive communication skills) and 19 (excellent expressive communication skills), with the average expressive communication skills score for a child (age adjusted) is 10 with standard deviation of 3.|24 Months after enrollment|only subjects that were randomized and had the 24 month Bayleys exam expressive communications scaled score were analyzed||units on a scale||Standard Error|Mean
847724|NCT00466817|Secondary|Neurological Impairment at 24 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Cognitive Composite Score).|Cognitive Composite Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Composite Scores, the range of scores are between 40 (very poor cognitive skills) and 160 (excellent cognitive skills), with the average cognitive skills score for a child (age adjusted) is 100 with standard deviation of 15.|24 months after enrollment|only subjects that were randomized and had the 24 month Bayleys exam cognitive composite score were analyzed||units on a scale||Standard Error|Mean
847725|NCT00466817|Secondary|Neurological Impairment at 24 Months Utilizing the Bayley Scales of Infant and Toddler Development (Receptive Communication Scaled Score).|Receptive Communication Scaled score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Scaled Scores, the range of scores is between 1 (very poor receptive communication skills) and 19 (excellent receptive communication skills), with the average receptive communication skills score for a child (age adjusted) is 10 with standard deviation of 3.|24 Months after enrollment|only subjects that were randomized and had the 24 month Bayleys exam receptive communication scaled were analyzed||units on a scale||Standard Error|Mean
847726|NCT00466817|Secondary|Neurological Impairment at 12 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Motor Composite Score).|Motor Composite Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Composite Scores, the range of scores is between 40 (very poor motor skills) and 160 (excellent motor skills), with the average motor skills score for a child (age adjusted) is 100 with standard deviation of 15.|12 Months after enrollment|only subjects that were randomized and had the 12 month Bayleys exam motor composite score were analyzed||units on a scale||Standard Error|Mean
847727|NCT00466817|Secondary|Neurological Impairment at 12 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Gross Motor Scaled Score).|Gross Motor Scaled Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Scaled Scores, the range of scores is between 1 (very poor gross motor skills) and 19 (excellent gross motor skills), with the average gross motor skills score for a child (age adjusted) is 10 with standard deviation of 3.|12 Months after enrollment|only subjects that were randomized and had the 12 month Bayleys exam gross motor score were analyzed||units on a scale||Standard Error|Mean
847728|NCT00466817|Secondary|Neurological Impairment at 12 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Fine Motor Scaled Score).|Fine Motor Scaled Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Scaled Scores, the range of scores is between 1 (very poor fine motor skills) and 19 (excellent fine motor skills), with the average fine motor skills score for a child (age adjusted) is 10 with standard deviation of 3.|12 Months after enrollment|only subjects that were randomized and had the 12 month Bayleys exam fine motor score were analyzed||units on a scale||Standard Error|Mean
847729|NCT00466817|Secondary|Neurological Impairment at 12 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Language Composite Score).|Language Composite Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Composite Scores, the range of scores is between 40 (very poor language skills) and 160 (excellent language skills), with the average language skills score for a child (age adjusted) is 100 with standard deviation of 15.|12 Months after enrollment|only subjects that were randomized and had the 12 month Bayleys exam language composite score were analyzed||units on a scale||Standard Error|Mean
847730|NCT00466817|Secondary|Neurological Impairment at 12 Months of Age Utilizing the Bayley Scales of Infant and Toddler Development (Expressive Communication Scaled Score).|Expressive Communication Scaled Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Scaled Scores, the range of scores is between 1 (very poor expressive communication skills) and 19 (excellent expressive communication skills), with the average expressive communication skills score for a child (age adjusted) is 10 with standard deviation of 3.|12 Months after enrollment|only subjects that were randomized and had the 12 month Bayleys exam expressinve Communications scaled score were analyzed||units on a scale||Standard Error|Mean
847731|NCT00466817|Secondary|Neurological Impairment at 12 Months of Age Utilizing the Bayley Scales of Infant and Toddler Development (Receptive Communication Scaled Score).|Receptive Communication Scaled Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Scaled Scores, the range of scores is between 1 (very poor receptive communication skills) and 19 (excellent receptive communication skills), with the average receptive communication skills score for a child (age adjusted) is 10 with standard deviation of 3.|12 Months after enrollment|only subjects that were randomized and had the 12 month Bayleys exam Receptive Communications scorewere analyzed||units on a scale||Standard Error|Mean
848714|NCT00602836|Secondary|Number of Participants With CD38 Testing at Baseline Who Also Had a Clinical Response (CR, nPR, or PR).|Response categories described in above outcome measures. CD38 status described in baseline characteristics section.|During treatment (up to 5 years)||||||
847732|NCT00466817|Secondary|Neurological Impairment at 12 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Cognitive Composite Score).|Cognitive Composite Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Composite Scores, the range of scores is between 40 (very poor cognitive skills) and 160 (excellent cognitive skills), with the average cogonitive skills score for a child (age adjusted) is 100 with standard deviation of 15.|12 Months after enrollment|only subjects that were randomized and had the 12 month Bayleys exam Cognitive Composite Score were analyzed||units on a scale||Standard Error|Mean
847733|NCT00466817|Secondary|Number of Ears With Hearing Deterioration Over Left and Right Ears at 24 Months.(Based on 58 Ears From 31 Placebo Subjects and 70 Ears From 37 Valganciclovir Subjects)|Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 24 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving “total ear” classifications. Following this, the study audiologist assigned the “best ear” classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the “best ear” classification was mild hearing loss.|Between baseline and 24 months|Only subjects randomized and subjects that had both baseline and 24 month hearing exams were analyzed for the primary endpoint. Some subjects failed to have the one or both of the two hearing exams (baseline and/or 24 months). There were 31 placebo subjects and 37 active drug subjects reported results for both time periods.||ears|||Number
847734|NCT00466817|Secondary|Number of Ears With Hearing Deterioration Over Left and Right Ears at 12 Months.(Based on 77 Ears From 40 Placebo Subjects and 79 Ears From 41 Valganciclovir Subjects)|Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 12 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving “total ear” classifications. Following this, the study audiologist assigned the “best ear” classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the “best ear” classification was mild hearing loss.|Between baseline and 12 months|Only subjects randomized and subjects that had both baseline and 12 month hearing exams were analyzed for the primary endpoint. Some subjects failed to have the one or both of the two hearing exams (baseline and/or 12 months). There were 40 placebo subjects and 41 active drug subjects reported results for both time periods||ears|||Number
847735|NCT00466817|Secondary|Number of Ears With Hearing Deterioration Over Left and Right Ears at 6 Months.(Based on 84 Ears From 43 Placebo Subjects and 82 Ears From 43 Valganciclovir Subjects)|Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 6 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving “total ear” classifications. Following this, the study audiologist assigned the “best ear” classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the “best ear” classification was mild hearing loss.|Between baseline and 6 months|Only subjects randomized and subjects that had both baseline and 6 month hearing exams were analyzed for the primary endpoint. Some subjects failed to have the one or both of the two hearing exams (baseline and/or 6 months). There were 43 subject in each group (placebo and active) that had both hearing results reported||ears|||Number
847736|NCT00466817|Secondary|Number of Ears With Improvement or Protected Hearing Assessments Over Left and Right Ears at 24 Months.(Based on 58 Ears From 31 Placebo Subjects and 70 Ears From 37 Valganciclovir Subjects)|Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 24 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving “total ear” classifications. Following this, the study audiologist assigned the “best ear” classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the “best ear” classification was mild hearing loss.|Between baseline and 24 months|Only subjects randomized and subjects that had both baseline and 24 month hearing exams were analyzed for the primary endpoint. Some subjects failed to have the one or both of the two hearing exams (baseline and/or 24 months). There were 31 placebo subjects and 37 active drug subjects reported results for both time periods.||ears|||Number
847743|NCT00465647|Secondary|Mean (SE) of Visual Analog Scale (VAS) [Ages 12-16] Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time|"The Visual Analog Scale (VAS), a 10-cm Color Analog Scale anchored by the descriptors of 0 = no pain and 10 = most pain, was used by children ≥ 12 years of age."|Immediately prior to first oral dose, up to 54 hours|The Full Analysis Population for Efficacy consisted of subjects who received at least 1 dose of oral hydromorphone HCl and had at least 1 subsequent efficacy evaluation (pain measurement or supplemental pain medication).||unit on a scale||Standard Error|Mean
847737|NCT00466817|Secondary|Number of Ears With Improvement or Protected Hearing in Hearing Assessments Over Left and Right Ears at 12 Months.(Based on 77 Ears From 40 Placebo Subjects and 79 Ears From 41 Valganciclovir Subjects)|Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 12 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving “total ear” classifications. Following this, the study audiologist assigned the “best ear” classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the “best ear” classification was mild hearing loss.|Between baseline and 12 months|Only subjects that were randomized and had baseline and 12 month hearing exams were analyzed.||ears|||Number
847738|NCT00466817|Secondary|Number of Ears With Improvement or Protected Hearing in Hearing Assessments Over Left and Right Ears at 6 Months.(Based on 84 Ears From 43 Placebo Subjects and 82 Ears From 43 Valganciclovir Subjects)|Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 6 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving “total ear” classifications. Following this, the study audiologist assigned the “best ear” classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the “best ear” classification was mild hearing loss.|Between baseline and 6 months|Only subjects randomized and subjects that had both baseline and 6 month hearing exams were analyzed for the primary endpoint. Some subjects failed to have the one or both of the two hearing exams (baseline and/or 6 months). There were 43 subject in each group (placebo and active) that had both hearing results reported||ears|||Number
847739|NCT00466817|Secondary|Change in Best Ear Hearing Assessments at 24 Months.|Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 24 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving “total ear” classifications. Following this, the study audiologist assigned the “best ear” classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the “best ear” classification was mild hearing loss.|Between baseline and 24 months|Only subjects randomized and subjects that had both baseline and 24 month hearing exams were analyzed for the primary endpoint. Some subjects failed to have the one or both of the two hearing exams (baseline and/or 24 months). There were 31 placebo subjects and 37 active drug subjects reported results for both time periods||participants|||Number
847740|NCT00466817|Secondary|Change in Best Ear Hearing Assessments at 12 Months.|Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 12 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving “total ear” classifications. Following this, the study audiologist assigned the “best ear” classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the “best ear” classification was mild hearing loss.|Between baseline and 12 months|Only subjects randomized and subjects that had both baseline and 12 month hearing exams were analyzed for the primary endpoint. Some subjects failed to have the one or both of the two hearing exams (baseline and/or 12 months). There were 40 placebo subjects and 41 active drug subjects reported results for both time periods||participants|||Number
847741|NCT00466817|Secondary|Adverse Events Which Lead to Permanent Discontinuation of Valganciclovir Therapy or Lead to Irreversible Outcome of the Adverse Event.|Adverse events were assessed at each visit through month 7 of the study. No subject discontinued valganciclovir therapy due to permanent discontinuation of valganciclovir therapy or lead to irreversible outcome of any adverse event.|baseline through 7 months|||participants|||Number
847742|NCT00466817|Primary|Change in Best Ear Hearing Assessments at 6 Months.|Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 6 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving “total ear” classifications. Following this, the study audiologist assigned the “best ear” classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the “best ear” classification was mild hearing loss.|Between baseline and 6 months|Only subjects randomized and subjects that had both baseline and 6 month hearing exams were analyzed for the primary endpoint. Some subjects failed to have the one or both of the two hearing exams (baseline and/or 6 months). There were 43 subject in each group (placebo and active) that had both hearing results reported||participants|||Number
847744|NCT00465647|Secondary|Mean (SE) of Faces Pain Scale-Revised (FPS-R) [Ages >= 5 Years-< 12 Years] Pain Scores on Hydromorphone Alone (Oral/Supplemental)Over Time|Faces Pain Scale-Revised (FPS-R) consists of 6 facial expressions. Each face is 25 x 35 mm with 13 mm between faces. Each subject was asked to point to the face that reflected his or her pain. The end points are 0 = no pain and 10 = very much pain. The FPS-R scale was used for children over the age of 5 up to 12 years who have appropriate verbal skills.|Immediately prior to first oral dose with potentially up to 54 hours duration.|The Full Analysis Population for Efficacy consisted of subjects who received at least 1 dose of oral hydromorphone HCl and had at least 1 subsequent efficacy evaluation (pain measurement or supplemental pain medication).||units on a scale||Standard Error|Mean
847745|NCT00465647|Secondary|Mean (SE) of Faces, Legs Activity, Cry, Consolability (FLACC) Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time [Ages >=28 Days to <5 Years]|There are 5 categories in this pediatric pain measurement: face, legs, activity, cry, and consolability. Responses in each category are scored between 0 and 2 (0 = normal, relaxed to 2 = upset, agitated), for a maximum total score of 10. The FLACC scale was used for children under the age of 3 years and older children who have limited verbal skills.|Immediately prior to first oral dose, up to 54 hours|The Full Analysis Population for Efficacy consisted of subjects who received at least 1 dose of oral hydromorphone HCl and had at least 1 subsequent efficacy evaluation (pain measurement or supplemental pain medication).||units on a scale||Standard Error|Mean
847746|NCT00465647|Primary|Population Pharmacokinetic/Pharmacodynamic (PK/PD) Model for Hydromorphone: Clearance (Cl)|"Model was built using sparse blood samples: Sampling times: immediately predose, and between 0.25-0.75, 1-3, and 4-6 hours postdose for the first 2 doses of oral hydromorphone: predose for each dose of oral hydromorphone HCl thereafter; and at the end of study.
Efficacy was based on Oral treatment only."|A maximum of 9 oral hydromorphone doses with potentially up to 54 hours duration.|The full analysis population for Pharmacokinetics/ Pharmacodynamics consisted of subjects who received at least 1 dose of oral hydromorphone HCl, and had at least 1 valid quantifiable PK sample. To be a valid sample, the time of administration of each dose of oral hydromorphone HCl, the dose, and the time of sample collection must be recorded.||L/hour||95% Confidence Interval|Number
847747|NCT00462943|Secondary|Kaplan-Meier Estimates for Overall Survival|Overall survival is defined as the time from the initiation of treatment until death from any cause or the last day of participant contact or evaluation for participants that were lost to follow-up. Participants were censored t the last recorded contract or evaluation when a participant was alive at time of analysis. A quarterly phone survey was conducted to collect survival data for participants who discontinued from the study.|up to 4 years|Intent to treat||months||95% Confidence Interval|Median
847748|NCT00462943|Secondary|Kaplan-Meier Estimates for Time to Disease Progression|Time to disease progression is defined as the time from the initiation of treatment until the onset date of death, the development of CML accelerated phase or blast phase, or the loss of complete hematologic response or major cytogenetic response, whichever came first. Participants were censored only if they did not have progression or if they discontinued treatment for reasons other than AE, progression or death.|up to 4 years|Intent to treat||months||95% Confidence Interval|Median
847749|NCT00462943|Secondary|Kaplan-Meier Estimates for Duration of Best Cytogenetic Response|Duration of response is defined as the time from first reported date of cytogenetic response until the earliest date of objective evidence of disease progression, relapse or death. Data was censored at the last examination date for participants with ongoing response or participants who discontinued treatment for reasons other than adverse event, disease progression or death.|up to four years|Intent to treat population of participants who had a response||months||Full Range|Median
847750|NCT00462943|Secondary|Kaplan-Meier Estimates for Duration of Best Hematologic Response|Duration of response is defined as the time from first reported date of hematologic response until the earliest date of objective evidence of disease progression, relapse or death. Data was censored at the last examination date for participants with ongoing response or participants who discontinued treatment for reasons other than adverse event, disease progression or death.|up to four years|Intent to treat population of participants who had a response||months||Full Range|Median
847751|NCT00462943|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Subpopulation and Total|"TEAE are any untoward events that were newly occurring or worsening from Baseline.
Treatment related toxicity was considered by the investigator to be unrelated, possibly, probably or unknown related to study drug. Severity was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 on the following scale: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening, Grade 5 = death. A serious adverse event (SAE) is any untoward medical occurrence that is fatal or life-threatening; results in persistent or significant disability or incapacity; requires or prolongs in-patient hospitalization; is a congenital anomaly/birth defect in the offspring of a patient; and conditions not included in the above that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above.
A participant is only counted once in each category (at worst severity or strongest relationship)."|up to 4 years|Intent to treat||participants|||Number
847752|NCT00462943|Secondary|Kaplan-Meier Estimates for Time to Onset of Best Cytogenetic Response|"Time to onset was analyzed using Kaplan-Meier estimates. Participants who did not achieve a response are censored at their last visit day.
Major cytogenetic response includes complete or partial response. Both confirmed and unconfirmed major cytogenetic response is considered meaningful. Unconfirmed response is based on a single bone marrow cytogenetic evaluation for participants where a confirmatory evaluation is not available.
Complete response shows 0% Philadelphia chromosome positive (Ph+) cells. A partial response shows >0% - 35% Ph+ cells."|Day 1 up to Month 9|Intent to treat population.||months||95% Confidence Interval|Median
847753|NCT00462943|Secondary|Kaplan-Meier Estimates for Time to Onset of Best Hematologic Response|"Time to onset was analyzed using Kaplan-Meier estimates. Participants who did not achieve a response are censored at their last visit day.
Overall hematologic response for chronic phase participants includes confirmed complete hematologic response (CHR). Overall hematologic response for accelerated or blast phase participants includes confirmed complete hematologic response (CHR), no evidence of leukemia (NEL), or return to chronic phase (RCP). Hematologic response must last >= 8 weeks to be considered meaningful."|Day 1 up to Month 6|Intent to treat population.||months||95% Confidence Interval|Median
847754|NCT00462943|Secondary|Number of Treatment Cycles Needed to Achieve Best Cytogenetic Response||Day 1 up to Month 9|Intent to treat population of participants who had a cytogenetic response||treatment cycles||Full Range|Median
847755|NCT00462943|Secondary|Number of Treatment Cycles Needed to Achieve Best Hematologic Response|Induction therapy was administered for 14 consecutive days for each 28 days cycle, for up to 6 cycles. All treatment arms were given omacetaxine mepesuccinate via subcutaneous (SC) administration at 1.25 mg/m^2 twice a day (BID) for the 14 consecutive days.|Day 1 up to Month 6|Intent to treat population of participants who had a response to treatment||treatment cycles||Full Range|Median
847756|NCT00462943|Secondary|Percentage of Participants With the Largest Percentage Reduction From Baseline of T315I Mutated BCR-ABL|Summarization is based on the best of the individual response assessments. Not assessable indicates that the participant either had no baseline assessment or the % mutation could not be determined in the post-baseline assessment(s).|Day 1 up to Month 9|Intent to treat population of participants with post-baseline assessment of T315I mutated BCR ABL||percentage of participants||95% Confidence Interval|Number
847757|NCT00462943|Secondary|Percentage of Participants With Extramedullary Disease (EMD) at Baseline Achieving a Clinical Response|"Clinical response was defined by disease phase and based on evaluations by the independent Data Monitoring Committee (DMC).
Chronic Phase subgroup: achieving a complete hematologic response and/or major cytogenetic response (complete cytogenetic response or partial cytogenetic response, confirmed or unconfirmed).
Accelerated Phase and Blast Phase subgroups: achieving complete hematologic response, no evidence of leukemia, return to chronic phase, and/or major cytogenetic response (complete cytogenetic response or partial cytogenetic response, confirmed or unconfirmed)."|Day 1 up to Month 9|Intent to treat population of study participants who had extramedullary disease at baseline||percentage of participants|||Number
847758|NCT00462943|Secondary|Percentage of Participants in Each Hematologic Response Category|"Complete Response (CHR)
Chronic phase must last at least 8 weeks: WBC <10*10^9/liter, platelets <450*10^9/liter, myelocytes + metamyelocytes <5% in blood, no blasts or promyelocytes in blood, <20% basophils in peripheral blood, no extramedullary involvement.
Accelerated and Blast phase must last at least 4 weeks: absolute neutrophil count 1.5*10^9/liter, platelets 100*10^9/liter, no blood blasts, bone marrow blasts <5%, no extramedullary disease.
Partial Response - CHR plus one or more of the following:
Persistence of splenomegaly with a reduction of ≥50% from pre-treatment
Platelets > 450*10^9/L
Presence of immature cells in the peripheral blood
5% to 25% blasts in the bone marrow
If extra-medullary disease pre-treatment, reduction by ≥50% Hematologic Improvement - CHR, except allowing persistent thrombocytopenia (<100*10^9/L), and a few immature cells No evidence of leukemia: Morphologic leukemia-free state, defined as <5% bone marrow blasts."|Day 1 up to Month 6|Intent to treat||percentage of participants|||Number
847759|NCT00462943|Secondary|Percentage of Participants With Major Molecular Response (MMR) Representing the Degree of Suppression of BCR-ABL Transcript Levels Using the Housekeeping Gene ABL|MMR is defined as a ratio of BCR-ABL/standard gene of less than 0.1% according to the international scale. BCR-ABL is a fusion gene of the breakpoint cluster region [BCR] gene and Abelson proto-oncogene [ABL] genes). This analysis used the standard gene ABL. Analysis was performed by quantitative reverse transcription polymerase chain reaction (qRT-PCR) of peripheral blood.|Day 1 up to Month 6|Intent to treat population of participants who had evaluable samples. Participants with no data for these analyses either had degraded samples or the samples were missing.||percentage of participants||95% Confidence Interval|Number
847760|NCT00462943|Secondary|Percentage of Participants With Major Molecular Response (MMR) Representing the Degree of Suppression of BCR-ABL Transcript Levels Using the Housekeeping Gene GUS|MMR is defined as a ratio of BCR-ABL/standard gene of less than 0.1% according to the international scale. BCR-ABL is a fusion gene of the breakpoint cluster region [BCR] gene and Abelson proto-oncogene [ABL] genes). This analysis used the standard gene GUS. Analysis was performed by quantitative reverse transcription polymerase chain reaction (qRT-PCR) of peripheral blood.|Day 1 up to Month 6|Intent to treat population of participants who had evaluable samples. Participants with no data for these analyses either had degraded samples or the samples were missing.||percentage of participants||95% Confidence Interval|Number
847761|NCT00462943|Secondary|Percentage of Participants in Each Cytogenetic Response Category Representing the Degree of Suppression of the Philadelphia Chromosome (Ph+)|"Cytogenetic response categories:
Complete: 0% Ph+ cells
Partial: >0%-35% Ph+ cells
Minor: >35%-65% Ph+ cells
Minimal: >65%-95% Ph+ cells
No Response: >95% Ph+ cells
Unevaluable: <20 metaphases were examined and/or response could not be assigned"|Day 1 up to Month 9|Intent to treat||percentage of participants|||Number
847762|NCT00462943|Primary|Percentage of Participants Achieving a Major Cytogenetic Response by Subpopulation and Total Population|"Subpopulations reflect chronic myeloid leukemia (CML) phases at the time of enrollment: chronic, accelerated, and blast phase. Primary endpoints as adjudicated by the Data Monitoring Committee were used for the primary analyses.
Major cytogenetic response includes complete or partial response. Both confirmed and unconfirmed major cytogenetic response is considered meaningful. Unconfirmed response is based on a single bone marrow cytogenetic evaluation for participants where a confirmatory evaluation is not available.
Complete response shows 0% Philadelphia chromosome positive (Ph+) cells. A partial response shows >0% - 35% Ph+ cells.
Response rates by disease phase were examined relative to an a priori value of 2.5% using a one-sided lower 95% exact binomial confidence limit. If the lower limit from the one-sided lower 95% confidence limit exceeds 2.5%, the observed response rate will have exceeded the minimum threshold required to demonstrate efficacy."|Day 1 up to 9 months|Intent to treat population||percentage of participants||95% Confidence Interval|Number
847763|NCT00462943|Primary|Percentage of Participants Achieving an Overall Hematologic Response by Subpopulation and Total Population|"Subpopulations reflect chronic myeloid leukemia (CML) phases at the time of enrollment: chronic, accelerated, and blast phase. Primary endpoints as adjudicated by the Data Monitoring Committee were used for the primary analyses.
Overall hematologic response for chronic phase participants includes confirmed complete hematologic response (CHR). Overall hematologic response for accelerated or blast phase participants includes confirmed complete hematologic response (CHR), no evidence of leukemia (NEL), or return to chronic phase (RCP). Hematologic response must last >= 8 weeks to be considered meaningful.
Response rates by disease phase were examined relative to an a priori value of 2.5% using a one-sided lower 95% exact binomial confidence limit. If the lower limit from the one-sided lower 95% confidence limit exceeds 2.5%, the observed response rate will have exceeded the minimum threshold required to demonstrate efficacy."|Day 1 up to 6 months|Intent to treat population||percentage of participants||95% Confidence Interval|Number
847764|NCT00457197|Secondary|Penn Alcohol Craving Scale (PACS)|"The PACS is a five-item self-administered instrument for assessing craving, frequency, intensity, and duration of thoughts about drinking are assessed along with ability to resist drinking
Score:
Minimum: 0 Maximum: 30 Lower score associated with better outcome."|12 weeks|Missing data for 1 participants in placebo group and 5 participants in the quetiapine group.||units on a scale||Standard Error|Least Squares Mean
847765|NCT00457197|Secondary|Young Mania Rating Scale (YMRS)|"This is an 11-item, observer rated measure of the severity of manic symptoms on a 5 point scale. The total score indicates overall severity of mania with a minimum of zero (indicating normalcy) and a maximum of 60 (indicating very severe).
Score:
Minimum: 0 Maximum: 60 Lower score associated with better outcome"|12 weeks|Missing data for 6 participants in placebo group and 1 participant in the quetiapine group.||units on a scale||Standard Error|Least Squares Mean
847766|NCT00457197|Secondary|Inventory of Depressive Symptomatology-Self Report (IDS-SR)|"IDS-SR is a self reported 30 item assessment to diagnose a major depressive episode.
Score:
Minimum: 0 Maximum: 84 Lower score associated with better outcome"|12 weeks|Missing data for 4 participants in placebo group and 2 participants in the quetiapine group.||units on a scale||Standard Error|Least Squares Mean
847767|NCT00457197|Secondary|Hamilton Rating Scale for Depression (HRSD)|"The assessment is a clinician administered rating of depression with 17 questions. The total score is indicates level of depression within the following ranges: none (0-5), mild (6-10), moderate (11-15), severe (16-20), and very severe (21+).
Scale:
Minimum: 0 Maximum: 50 Lower score associated with better outcome"|12 weeks|Missing data for 2 participants in placebo group and 3 participants in the quetiapine group.||units on a scale||Standard Error|Least Squares Mean
847768|NCT00457197|Secondary|Alanine Aminotransferase (ALT)|ALT is a liver enzyme measurement (IU/I).|12 weeks|Missing data for 17 participants in placebo group and 13 participants in the quetiapine group.||IU/I||Standard Error|Least Squares Mean
847769|NCT00457197|Secondary|Aspartate Aminotransferase (AST)|AST is a liver enzyme measurement (IU/I)|12 weeks|Missing data for 19 participants in placebo group and 11 participants in the quetiapine group.||IU/I||Standard Error|Least Squares Mean
847770|NCT00457197|Secondary|Gamma-glutamyltransferase (GGT)|GGT is a liver enzyme measurement (IU/I)|12 weeks|Missing data for 18 participants in placebo group and 11 participants in the quetiapine group.||IU/I||Standard Error|Least Squares Mean
847771|NCT00457197|Secondary|Percent of Heavy Drinking Days||12 weeks|||drinks||Standard Error|Least Squares Mean
847772|NCT00457197|Primary|The Number of Standard Drinks/Day Will Serve as the Primary Outcome Measure.||12 weeks|||drinks||Standard Error|Least Squares Mean
847773|NCT00455013|Secondary|Number of Participants Who Switched Between MMF and Sirolimus During Long Term Extension up to Study Completion|Long Term extension was the period from the end of Month 12 to the end of Month 48 post transplantation and the completion of the study 31 July 2012. At any time in the study, participants who were unable to tolerate MMF in the Bela-MMF and Tac-MMF groups could discontinue (DC) MMF and switch to sirolimus and remain in the study and those in the Bela-Siro group who were unable to tolerate sirolimus could DC sirolimus and switch to MMF and remain in the study. Study completion=data base (DB) lock.|End of Month 12 to end of Study (Month 48)|N= All participants who completed the ST period, were eligible and accepted to enter the LTE by signing a new informed consent form||participants|||Number
847774|NCT00455013|Secondary|Number of Participants Who Were Both Calcineurin Inhibitor-free (CNI-free)and Corticosteroid-free at Months 24, 36, 48 Post Transplantation - Intent to Treat Population in Long Term Extension|Participants were considered corticosteroid-free at Months 24, 36, and 48 if they were not receiving corticosteroids for >7 consecutive days during Day 701 and Day 756, Day 1065 and Day 1120, as well as Day 1429 and Day 1484, respectively. Participants were considered CNI-free at Months 24, 36, and 48 if they were not receiving CNI during Day 701 and Day 756, Day 1065 and Day 1120, as well as Day 1429 and Day 1484, respectively. Participants in the tacrolimus arm were not relevant to this analysis because tacrolimus is a calcinurin inhibitor.|Months 24, 36, 48|N= All participants who completed the ST period, were eligible and accepted to enter the LTE by signing a new informed consent form, and had data available at the specific time point were analyzed.||participants|||Number
847775|NCT00455013|Secondary|Number of Corticosteroid-free Participants at Months 24, 36, 48 Post Transplantation - Intent to Treat Population in Long Term Extension|In the LTE, a participant was considered corticosteroid-free if they were not receiving corticosteroids for >7 consecutive days during Day 701 and Day 756, Day 1065 and Day 1120, as well as Day 1429 and Day 1484, respectively.|End of Month 12 to end of Long Term Extension (Year 4)|N= All participants who completed the ST period, were eligible and accepted to enter the LTE by signing a new informed consent form, and had data available at the specific time point were analyzed.||participants|||Number
847776|NCT00455013|Secondary|Mean (Standard Deviation) in Calculated Glomerular Filtration Rate (GFR) mL/Min/1.73m^2 at Months 24, 36 and 48 Post Transplantation - Intent to Treat Population in Long Term Extension|GFR was calculated based upon serum creatinine (SCr) using the Modification of Diet in Renal Disease (MDRD) formula as suggested by Levey et al: MDRD GFR = 170 x [SCr/0.95]^(-0.999) x [Age]^(-0.176) x [0.762 if participant was female] x [1.180 if participant was black] x [BUN]^(-0.170) x [Alb]^(+0.318). Age in years, Alb = Albumin in g/dL; SCr = in mg/dL; BUN =Blood urea nitrogen in mg/dL. Intent to Treat population is defined as all participants randomized and transplanted.|Months 24, 36 and 48 post transplantation|N=All participants who were randomized, transplanted, in the LTE and had data available at the specific time point.||mL/Min/1.73m^2||Standard Deviation|Mean
847777|NCT00455013|Secondary|Number of Participants With Graft Loss or Death at Months 24, 36, 48 Post Transplantation - Intent to Treat Population in Long Term Extension|Graft loss was defined as either functional loss or physical loss. Functional loss was defined as either: sustained level of SCr greater than or equal to (>=) 6.0 mg/dL (530 micromoles/Liter; micromol/L) for >= 4 weeks as determined by the local laboratory; regularly scheduled dialysis treatments over a period of 56 days; impairment of renal function to such a degree that the participant undergoes re-transplant. Day 1 was day of transplantation. ITT population defined as all participants randomized and transplanted.|End of Month 12 to end of Long Term Extension (Year 4)|N=participants randomized and transplanted and in LTE.||participants|||Number
847909|NCT00379821|Secondary|Mean Alanine Transaminase (ALT) in Each Treatment Arm (Hepatic Function)|ALT values were assessed from blood draws at Day 0 and Day 14 of each malaria episode.|Day 14 of third subsequent malaria episode (Episode 3)|The safety population includes all participants who have laboratory results reported at the time point for the episode.||International Units/Liter||95% Confidence Interval|Mean
847778|NCT00455013|Secondary|Number of Participants With Acute Rejection of Transplant up to End of Month 48 Post Transplantation - Intent to Treat Population in Long Term Extension|AR defined as a clinicopathological event requiring clinical evidence and biopsy confirmation by central pathologist. One or more conditions were met and a renal biopsy revealed histologic evidence of rejection: unexplained rise of serum creatine (SCr) >= 25 % from baseline plus one or more of the following: unexplained decreased urine output; fever and graft tenderness; a SCr that remained elevated within 14 days after transplantation and clinical suspicion of AR; reason other than those listed and participant was treated for this episode. Day 1 was day of transplantation. Banff grade used Banff 97 working classification of kidney transplant pathology. ITT population was all randomized and transplanted participants.|End of Month 12 to end of Month 48 Post Transplantation|All participants who completed the short term (ST) period, were eligible and accepted to enter the LTE by signing a new informed consent form.||participants|||Number
847779|NCT00455013|Secondary|Number of Participants Who Were Corticosteroid-free at Months 6 and 12 and Number of Participants Who Were Both Calcineurin Inhibitor-free (CNI-free)and Corticosteroid-free at Months 6 and 12 Post Transplantation - Intent to Treat Population|Participants were said to be CNI-free at Month 6 or 12 if they were not receiving a CNI during Day 141 to Day 196, or Day 337 to Day 392. Participants in the tacrolimus arm were not relevant to this analysis because tacrolimus is a calcinurin inhibitor. Participants were corticosteroid-free (CS-free) at Month 6 if they were not receiving corticosteroids for > 7 consecutive days during Days 141 through Days 196, and at Month 12 if not receiving corticosteroids for > 7 days during Days 337 through 392. Day 1 was day of transplantation. Intent to treat population included all randomized and transplanted participants.|Day 1 to Month 12 post transplantation|Analysis on both CNI-free and CS-free participants based on all followed up at least 151 days for Month 6 or 347 days for Month 12. One participant in the tacrolimus arm was counted as CNI-free since he discontinued tacrolimus on Day 2 of transplant and no data were available regarding immunosuppressive therapy after discontinuation.||participants|||Number
847780|NCT00455013|Secondary|Number of Corticosteroid-free Participants at 6 and 12 Months Post Transplantation - Intent to Treat Population|Participants were said to be corticosteroid-free at Month 6 if they were not receiving corticosteroids for greater than (>) 7 consecutive days during Days 141 through Days 196, and at Month 12 if not receiving corticosteroids for > 7 days during Days 337 through 392. Intent to treat population included all randomized and transplanted participants.|Day 1 through Month 12|For 95% CI within each group, normal approximation was used if N greater than, equal to (>=)5. Otherwise, exact method was used. Numbers of participants analyzed at Month 6 in each arm were 33, 26, 30 and numbers of participants analyzed at Month 12 were 32, 26, 30, in belatacept/MMF, belatacept/sirolimus, and tacrolimus/MMF arms, respectively.||participants|||Number
847781|NCT00455013|Secondary|Mean (Standard Deviation) in Calculated Glomerular Filtration Rate (GFR) mL/Min/1.73m^2 at Month 3, Month 6 and Month 12 Post Transplantation - Intent to Treat Population|Blood urea nitrogen (BUN) in mg/dL; Albumin (Alb) in g/dL;Serum creatinine (SCr) in mg/dL; Age in years. Glomerular filtration rate (GFR) was calculated based upon serum creatinine (SCr) using the Modification of Diet in Renal Disease (MDRD) formula as suggested by Levey et al: MDRD GFR = 170 x [SCr/0.95]^(-0.999) x [Age]^(-0.176) x [0.762 if participant was female] x [1.180 if participant was black] x [BUN]^(-0.170) x [Alb]^(+0.318). Intent to Treat (ITT) population is defined as all participants randomized and transplanted.|Months 3, 6 and 12 post transplantation|Month 12 n presented above. Calculated GFR, values >180 mL/min/1.73 m2 (beyond upper limit of biologic plausibility)were truncated at 180 mL/min/1.73 m^2. Based on median (SD) GFR of 83 (50).||mL/min/1.73m^2||Standard Deviation|Mean
847782|NCT00455013|Secondary|Mean Change From Baseline (BL) to Month 12 Post Transplantation in Lipid Values - Intent to Treat Population|Baseline (BL) was value obtained day prior to transplantation. Lipid values measured in milligrams/deciliter (mg/dL) included: high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), non-HDL cholesterol (non-HDL-C), total cholesterol (TC), triglycerides. Intent to treat population included all participants randomized and transplanted.|Baseline to Month 12|33, 26, 30 participants were included in the ITT population. Number of participants analyzed for HDL-C = 26, 22, 26; non-HDL-C = 26, 22, 26; LDL-C = 20, 14, 21; TC = 26, 22, 26; triglycerides = 20, 14, 21, in belatacept/MMF, belatacept/sirolimus, and tacrolimus/MMF arms, respectively.||mg/dL||Standard Deviation|Mean
847783|NCT00455013|Secondary|Number of Participants Using Antihyperlipidemic Medications at Month 12 - Intent to Treat Population|Participants using > = 1 antihyperlipidemic medication at Month 12.|Month 12|Analysis based on all participants who were followed up at least 364 days.||participants|||Number
847784|NCT00455013|Secondary|Mean Systolic, Diastolic and Arterial Blood Pressure at Baseline and Month 12 - Intent to Treat Population|Systolic, diastolic and mean arterial blood pressures were measured in millimeters of mercury (mm Hg). Baseline was defined as value obtained before transplantation. Intent to treat population included all participants randomized and transplanted.|Baseline and 12 months post transplantation|Number analyzed at baseline presented above. Number analyzed at Month 12: 28, 22, 29 in belatacept/MMF, belatacept/sirolimus, and tacrolimus/MMF treatment arms,respectively. Measurements obtained immediately after drug infusion were excluded from analysis.||mm Hg||Standard Deviation|Mean
847785|NCT00455013|Secondary|Number of Participants Who Used Anti-hypertension Medications at Baseline and at 12 Months Post Transplantation - Intent to Treat Population|Baseline was defined as day prior to transplantation. Number of anti-hypertension medications taken were categorized from 1 to 6 and greater than (>)6. Intent to treat population included all participants randomized and transplanted.|Baseline and Month 12|ITT population, 33, 26, 30 for each arm, respectively, was used for each time point (baseline and Month 12). At baseline, 2 participants in each arm were not using at least one medication. 8, 6, and 10 participants in each arm respectively, were not using at least one medication at Month 12.||participants|||Number
847795|NCT00453180|Secondary|Social Responsiveness Scale|The Social Responsiveness Scale (SRS) is a 65-item scale that assesses social impairment in the aspects of social awareness, social cognition, social communication, social motivation and autistic mannerisms. Each item is scored from 0 (not true) to 3 (almost always true). The total SRS raw score may range from 0-195, where higher scores indicate greater severity.|Week 12|||units on a scale||Standard Deviation|Mean
848282|NCT00121641|Other Pre-specified|Changes From Baseline in Systolic Blood Pressure During the ST + LT Period||Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point||mmHg||Standard Error|Mean
847786|NCT00455013|Secondary|Number of Participants With New Onset Diabetes Mellitus From Baseline to Month 12 Post Transplantation - Intent to Treat Population|"Baseline defined as day before transplantation. A participant who did not have diabetes prior to randomization and received an antidiabetic medication for a duration of at least 30 days or a participant who meets the following criteria and did not have diabetes prior to randomization: Symptoms of diabetes plus casual plasma glucose (PG) concentration ≥ 200 mg/dL (11.1 mmol/L); or fasting plasma glucose ≥ 126 mg/dL (7.0 mmol/L); or 2-hour PG ≥ 200 mg/dL (11.1 mmol/L) during an oral glucose tolerance test and a confirmatory laboratory test based on measurements of venous PG must have been done on another day in the absence of unequivocal hyperglycemia accompanied by acute metabolic decompensation.
Intent to treat population included all participants randomized and transplanted."|Baseline to Month 12|||participants|||Number
847787|NCT00455013|Secondary|Number of Participants With Delayed Graft Function - Intent to Treat Population|Delayed graft function (DGF) is defined as participant requiring dialysis within the first week (Day 1-8) post transplantation. Participants losing their graft less than 48 hours post transplant and receiving chronic dialysis were not considered as having DGF. Day 1 was day of transplantation. Intent to treat population defined as all participants randomized and transplanted|From Day 1 up to and including Day 8 post transplantation|||participants|||Number
847788|NCT00455013|Secondary|Number of Participants With Composite of Death, Graft Loss and Acute Rejection up to Month 12 - Intent to Treat Population|Subjects with graft loss or death prior to Month 12 were considered having an event of AR, therefore, the incidence of AR was reported as a composite of AR, death, and graft loss.|Day 1 up to Month 12|||participants|||Number
847789|NCT00455013|Secondary|Number of Participants With Composite of Death, Graft Loss and Acute Rejection up to Month 6 - Intent to Treat Population|Participants with graft loss or death prior to Month 6 were considered having an event of AR, therefore, the incidence of AR was reported as a composite of AR, death, and graft loss.|Day 1 up to Month 6|Intent to treat population included all randomized and transplanted participants.||participants|||Number
847790|NCT00455013|Secondary|Number of Participants With Graft Loss or Death up to Month 6 and Month 12 Post Transplantation - Intent to Treat Population|Graft loss was defined as either functional loss or physical loss. Functional loss was defined as either: sustained level of SCr greater than or equal to (>=) 6.0 mg/dL (530 micromoles/Liter; micromol/L) for >= 4 weeks as determined by the local laboratory; regularly scheduled dialysis treatments over a period of 56 days; impairment of renal function to such a degree that the participant undergoes re-transplant. Day 1 was day of transplantation. ITT population defined as all participants randomized and transplanted.|Day 1 to Month 6 and Month 12 post transplantation|Participants surviving with a functioning graft were 30, 24, 30 in belatacept/MMF, belatacept/sirolimus, tacrolimus/MMF arms, respectively. Participant who died had functioning graft at time of death.||participants|||Number
847791|NCT00455013|Secondary|Number of Participants With Acute Rejection of Transplant up to Month 12 Post Transplantation - Intent to Treat Population|AR defined as a clinicopathological event requiring clinical evidence and biopsy confirmation by central pathologist. One or more conditions were met and a renal biopsy revealed histologic evidence of rejection: unexplained rise of serum creatine (SCr) >= 25 % from baseline plus one or more of the following: unexplained decreased urine output; fever and graft tenderness; a SCr that remained elevated within 14 days after transplantation and clinical suspicion of AR; reason other than those listed and participant was treated for this episode. Day 1 was day of transplantation. Banff grade used Banff 97 working classification of kidney transplant pathology. ITT population was all randomized and transplanted participants.|Day 1 to Month 12 post transplantation|For 95% CI within each group, normal approximation was used if N greater than, equal to 5. Otherwise, exact method was used.||participants|||Number
847792|NCT00455013|Primary|Number of Participants With Acute Rejection (AR) of Transplant up to 6 Months Post Transplantation - Intent to Treat (ITT) Population|AR is clinicopathological event requiring clinical evidence and biopsy confirmation by central pathologist. One or more conditions were met and a renal biopsy revealed histologic evidence of rejection: unexplained rise of serum creatine (SCr) greater than or equal to 25% from baseline plus one or more of the following: unexplained decreased urine output; fever, graft tenderness; SCr that remained elevated 14 days post-transplantation and clinical suspicion of AR; other reason and participant treated for episode. Day 1=transplantation. Banff 97 working classification of kidney transplant pathology: Type I=tubulointerstitial AR without arteritis (IA: interstitial infiltration with >25% of parenchyma affected and moderate tubulitis with >4 mononuclear cells/tubular cross section; IB: >10 mononuclear cells; Type II vascular AR with (IA) intimal arteritis (IIA=mild - moderate; IIB=severe; Type III=severe rejection with transmural arterial changes, necrosis of smooth muscle cells.|Day 1 to Month 6 post-transplantation|Participants with more than one episode of AR were counted once only and the episode with the worst grade was used. For 95% Confidence Interval (CI) within each group, normal approximation was used if N greater than, or equal to (>=) 5. Otherwise, exact method was used. ITT population defined as all randomized and transplanted participants.||participants|||Number
847793|NCT00453180|Secondary|Vineland Adaptive Behavior Scales-II (VABS-II)|The VABS-II is a semi-structured interview designed to assess adaptive functioning in the domains of communication, daily living skills and socialization. Items in each domain are rated as either 0 (does not), 1(sometimes) or 2(independently) performs a given behavior or skill. The communication domain has 99 items with scores ranging from 0-198. The daily living skills domain has 109 items with scores ranging from 0-218. The socialization domain has 99 items with scores ranging from 0-198. The domains scores are combined to form the adaptive composite score (ranging from 20-160). The raw scores from the communication, daily living skills and socialization domains along with the composite score were selected for use in this study. Higher scores indicate a higher level of adaptive functioning.|Week 12|||units on a scale||Standard Deviation|Mean
847794|NCT00453180|Secondary|Pervasive Developmental Disorder Behavior Index|The PDD Behavior Inventory (PDDBI) is a rating scale filled out by caregivers or teachers that was designed to assess children having a Pervasive Developmental Disorder (PDD; autism, Asperger disorder, PDD-NOS, or childhood disintegrative disorder). Both adaptive and maladaptive behaviors are assessed in the scale, making it useful for treatment studies in which decreases in maladaptive behaviors and improvements in adaptive social and language skills relevant to PDD are expected.|Week 12|Less than 25% of participants in each group received a score on the PDDBI due to a significant floor effect. As a result, the data for these participants are not considered reliable given the significant floor effect.|||||
847796|NCT00453180|Secondary|Aberrant Behavior Checklist|The Aberrant Behavior Checklist (ABC) is a 58-item measure of maladaptive behaviors and is used as a measure of drug effects. Each of the 58 items are rated from 0 (not at all) to 3 (severe).The ABC has 5 subscales: Irritability (15 items) ranging from 0 (not at all) to 45 (severe), Lethargy (16 items) ranging from 0 (not at all) to 48 (severe), Stereotypy (7 items) ranging from 0 (not at all) to 21 (severe), Hyperactivity (16 items) ranging from 0 (not at all) to 48 (severe), and Inappropriate Speech (4 items) ranging from 0 (not at all) to 12 (severe). Higher scores indicate a higher level of maladaptive behavior.|Week 12|||units on a scale||Standard Deviation|Mean
847797|NCT00453180|Primary|Clinical Global Impression - Improvement|"Clinical Global Impression - Improvement (CGI-I) is designed to take into account all factors to arrive at an assessment of response to treatment.
The CGI-I scale ranges from 1 to 7 (1=very much improved; 2=much improved, 3=minimally Improved, 4=no change, 5=minimally worse, 6= much worse and 7=very much worse). Participants with a CGI-I score of 1 or 2 were classified as improved. Participants with a CGI score of 3, 4 or 5 were classified as no response. No participants scored 6 or 7."|Week 12|||Participants|||Count of Participants
847798|NCT00453180|Primary|Clinical Global Impression - Severity|The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.|Week 12|||Participants|||Count of Participants
847799|NCT00452335|Secondary|Treatment Effectiveness|Treatment effectiveness was assessed with the following scale: 0 = not at all effective, 1 = a little bit effective, 2 = moderately effective, 3 = quite a bit effective, and 4 = extremely effective.|Weekly, up to 4 weeks|ITT Population||units on a scale||Standard Deviation|Mean
847800|NCT00452335|Secondary|Constipation Severity|Constipation severity was assessed based on the following scale 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe.|Weekly, up to 4 weeks|ITT Population||units on a scale||Standard Deviation|Mean
847801|NCT00452335|Secondary|Pain Associated With SBMs|Pain associated with SBMs was assessed based on the following scale: 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain, and 4 = very severe pain.|Weekly, up to 4 weeks|ITT Population||units on a scale||Standard Deviation|Mean
847802|NCT00452335|Secondary|Abdominal Discomfort|Abdominal discomfort was assessed based on the following scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe.|Weekly, up to 4 weeks|ITT Population||units on a scale||Standard Deviation|Mean
847803|NCT00452335|Secondary|Abdominal Bloating|Abdominal bloating was assessed based on the following scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe.|Weekly, up to 4 weeks|ITT Population||units on a scale||Standard Deviation|Mean
847804|NCT00452335|Secondary|Stool Consistency of SBMs|Stool consistency was captured using the Bristol Stool Form Scale: 1 = Separate hard lumps like nuts, 2 = Sausage shaped but lumpy, 3 = Like a sausage but with cracks on surface, 4 = Like a sausage or snake, smooth and soft, 5 = Soft blobs with clear-cut edges, 6 = Fluffy pieces with ragged edges, a mushy stool, and 7 = Watery, no solid pieces.|Weekly, up to 4 weeks|ITT Population||units on a scale||Standard Deviation|Mean
847805|NCT00452335|Secondary|Straining Associated With SBMs|Bowel straining assessed based on the following scale: 0 = no straining, 1 = mild straining, 2 = moderate straining, 3 = severe straining, and 4 = very severe straining.|Weekly, up to 4 weeks|ITT Population||units on a scale||Standard Deviation|Mean
847806|NCT00452335|Secondary|Frequency of Fecal Incontinence|As part of the daily diary, patients were asked to report the number of fecal incontinence episodes per day.|Weekly, up to 4 weeks|ITT Population||episodes of fecal incontinence per day||Standard Deviation|Mean
847807|NCT00452335|Secondary|Frequency of Spontaneous Bowel Movements|Gathered as part of the daily electronic diary questions.|Weeks 2, 3, and 4|ITT Population||spontaneous bowel movements per week||Standard Deviation|Mean
847808|NCT00452335|Primary|Frequency of Spontaneous Bowel Movements|Gathered as part of the daily electronic diary questions.|Week 1|ITT population||spontaneous bowel movements per week||Standard Deviation|Mean
847809|NCT00445003|Secondary|Change in Optical Coherence Tomography Retinal Volume|Missing or un-gradable data as follows for the sham plus focal/grid/panretinal photocoagulation laser, triamcinolone plus focal/grid panretinal photocoagulation laser, and Ranibizumab groups were 49, 37, and 39, respectively|Baseline to 14 weeks|Participants with two study eyes enrolled each eye in a different treatment group. Therefore, each treatment group/arm includes no more than one study eye for a given participant, and thus the numbers of eyes is equal to the number of participants in each arm.||mm^3||Standard Deviation|Mean
847810|NCT00445003|Secondary|Number of Eyes With Additional Number of Treatments for Diabetic Macular Edema|Treatments include any type or combination of treatment for diabetic macular edema. Eyes were only counted once, when receiving a combination of treatments.|14 weeks to 56-weeks|Participants with two study eyes enrolled each eye in a different treatment group. Therefore, each treatment group/arm includes no more than one study eye for a given participant, and thus the numbers of eyes is equal to the number of participants in each arm.||Eyes|||Number
847811|NCT00445003|Secondary|Eyes With Anti-vascular Endothelial Growth Factor Treatment for Diabetic Macular Edema||14 weeks to 56-weeks|Participants with two study eyes enrolled each eye in a different treatment group. Therefore, each treatment group/arm includes no more than one study eye for a given participant, and thus the numbers of eyes is equal to the number of participants in each arm.||Eyes|||Number
847812|NCT00445003|Secondary|Change in Visual Acuity From Baseline|Visual Acuity was measured with the Electronic Early Treatment Study (E-ETDRS) visual acuity test. Unit of measure is based on the E-ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.|baseline to 56-weeks|Participants with two study eyes enrolled each eye in a different treatment group. Therefore, each treatment group/arm includes no more than one study eye for a given participant, and thus the numbers of eyes is equal to the number of participants in each arm.||Letter Score||Standard Deviation|Mean
847910|NCT00379821|Secondary|Mean Alanine Transaminase (ALT) in Each Treatment Arm (Hepatic Function)|ALT values were assessed from blood draws at Day 0 and Day 14 of each malaria episode.|Day 0 of third subsequent malaria episode (Episode 3)|The safety population includes all participants who have laboratory results reported at the time point for the episode.||International Units/Liter||95% Confidence Interval|Mean
847813|NCT00445003|Secondary|Total Optical Coherence Tomography Retinal Volume|Missing/ungradable as follows: Sham = 49, Ranibizumab = 37, Triamcinolone = 39. Visits occured between 70 days and 153 days from randomization adjusted for baseline optical coherence tomography (OCT) retinal volume, OCT retinal thickness and visual acuity, number of planned panretinal photocoagulation sittings, and correlation between 2 study eyes. Confidence intervals are adjusted for multiple comparisons.|Baseline to 14-weeks|Participants with 2 study eyes enrolled each eye in a different arm. Therefore, each arm includes no more than 1 eye for a given participant, and thus the numbers of eyes is equal to number of participants.||mm^3||Standard Deviation|Mean
847814|NCT00445003|Secondary|Change in Optical Coherence Tomography Central Subfield Thickness||Baseline to 14 weeks|Participants with two study eyes enrolled each eye in a different treatment group. Therefore, each treatment group/arm includes no more than one study eye for a given participant, and thus the numbers of eyes is equal to the number of participants in each arm.||Microns||Inter-Quartile Range|Median
847815|NCT00445003|Secondary|Additional Treatments for Diabetic Macular Edema|Each combination of treatment is only counted once per treatment eye. Participants could have 2 study eyes, with random assignments to different treatments.|14 weeks to 56-weeks|||Eyes|||Number
847816|NCT00445003|Primary|Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 14 Weeks|Visual Acuity was measured with the Electronic Early Treatment Study (E-ETDRS) visual acuity test. Unit of measure is based on the E-ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.|baseline to 14 weeks|Participants with 2 study eyes enrolled each eye in a different arm. Each arm includes no more than 1 study eye for a given participant, and thus the numbers of eyes is equal to the number of participants in each arm. Analysis followed intention to treat principle; eyes without 14-week data, the Last Observation Carried Forward method was used.||Letter Score||Standard Deviation|Mean
847817|NCT00443781|Primary|Difference in Number of Magnetic Resonance Imaging (MRI)-Positive Discs Diagnosed Positive by Provocative Discography (PD) and Functional Anesthetic Discography (F.A.D.)|For provocative discography (PD), a positive response at an individual disc requires all of the following findings: pain intensity (>=7/10 on 0-10 Numerical Rating Scale, NRS) as rated by subjects on injecting contrast into a disc; concordancy (pain reproduces typical back pain exactly). For Functional Anesthetic Discography (F.A.D.), a positive test at an individual disc level is defined as improvement in self-rated pain of >=2 Numerical Rating Scale (NRS) points AND >33% on 0-10 Numerical Rating Scale 10 minutes after injection of lidocaine.|Approximately 2 hours per subject|Subjects which underwent Provocative Discography (PD) and Functional Anesthetic Discography (F.A.D.) consist of 1 population (N=50). Subjects which underwent either PD, F.A.D. or neither diagnostic test consist of a second population (all subjects enrolled, N=62). This is a diagnostic study. No imputation technique was used.||discs|Participants||Number
847818|NCT00436969|Secondary|12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 6 Months (As Treated)|"The difference in 12-Item Short Form Survey (SF-12) Mental score calculated as visit score - baseline score.
The SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health.
Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health."|Baseline and 6 months|The As Treated analysis population included all subjects that received treatment and had outcome data.||units on a scale||Standard Error|Least Squares Mean
847819|NCT00436969|Secondary|12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 6 Months (Per Protocol)|"The difference in 12-Item Short Form Survey (SF-12) Mental score calculated as visit score - baseline score.
The SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health.
Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health."|Baseline and 6 months|The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation.||units on a scale||Standard Error|Least Squares Mean
847820|NCT00436969|Secondary|12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 12 Weeks (As Treated)|"The difference in 12-Item Short Form Survey (SF-12) Mental score calculated as visit score - baseline score.
The SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health.
Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health."|Baseline and 12 weeks|The As Treated analysis population included all subjects that received treatment and had outcome data.||units on a scale||Standard Error|Least Squares Mean
847821|NCT00436969|Secondary|12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 12 Weeks (Per Protocol)|"The difference in 12-Item Short Form Survey (SF-12) Mental score calculated as visit score - baseline score.
The SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health.
Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health."|Baseline and 12 weeks|The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation. Subjects were allowed to have missing interim visits (i.e. 12 weeks).||units on a scale||Standard Error|Least Squares Mean
847822|NCT00436969|Secondary|12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 6 Months (As Treated)|"The difference in 12-Item Short Form Survey (SF-12) Physical score calculated as visit score - baseline score.
The SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health.
Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health."|Baseline and 6 months|The As Treated analysis population included all subjects that received treatment and had outcome data.||units on a scale||Standard Error|Least Squares Mean
847823|NCT00436969|Secondary|12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 6 Months (Per Protocol)|"The difference in 12-Item Short Form Survey (SF-12) Physical score calculated as visit score - baseline score.
The SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health.
Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health."|Baseline and 6 months|The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation.||units on a scale||Standard Error|Least Squares Mean
847824|NCT00436969|Secondary|12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 12 Weeks (As Treated)|"The difference in 12-Item Short Form Survey (SF-12) Physical score calculated as visit score - baseline score.
The SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health.
Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health."|Baseline and 12 weeks|The As Treated analysis population included all subjects that received treatment and had outcome data.||units on a scale||Standard Error|Least Squares Mean
847825|NCT00436969|Secondary|12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 12 Weeks (Per Protocol)|"The difference in 12-Item Short Form Survey (SF-12) Physical score calculated as visit score - baseline score.
The SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health.
Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health."|Baseline and 12 weeks|The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation. Subjects were allowed to have missing interim visits (i.e. 12 weeks).||units on a scale||Standard Error|Least Squares Mean
847826|NCT00436969|Secondary|Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 6 Months (As Treated)|"The difference in Shoulder Pain and Disability Index (SPADI) Total Disability score calculated as visit score - baseline score.
The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain, where: 0 = no pain and 10 = the worst pain imaginable. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use, where: 0 = no difficulty and 10 = so difficult it requires help.
Scoring instructions: The scores from both dimensions are averaged to derive a total score."|Baseline and 6 months|The As Treated analysis population included all subjects that received treatment and had outcome data.||units on a scale||Standard Error|Least Squares Mean
847827|NCT00436969|Secondary|Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 6 Months (Per Protocol)|"The difference in Shoulder Pain and Disability Index (SPADI) Total Disability score calculated as visit score - baseline score.
The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain, where: 0 = no pain and 10 = the worst pain imaginable. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use, where: 0 = no difficulty and 10 = so difficult it requires help.
Scoring instructions: The scores from both dimensions are averaged to derive a total score."|Baseline and 6 months|The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation.||units on a scale||Standard Error|Least Squares Mean
847828|NCT00436969|Primary|Visual Analog Scale (VAS) Pain Score (As Treated)|Scores are measured on a 100 mm Visual Analog Scale (VAS). The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain.|6 Months|The As Treated analysis population included all subjects that received treatment and had outcome data.||mm on a 100 mm VAS scale||Standard Error|Least Squares Mean
847836|NCT00436969|Secondary|Visual Analog Scale (VAS) Pain Score Change From Baseline and 12 Weeks (Per Protocol)|The difference in pain was calculated as visit score - baseline score. Scores are measured on a 100 mm visual analogy scale.|Baseline and 12 weeks|The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation. Subjects were allowed to have missing interim visits (i.e. 12 weeks).||mm on a 100 mm VAS scale||Standard Error|Least Squares Mean
847829|NCT00436969|Secondary|Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 12 Weeks (As Treated)|"The difference in Shoulder Pain and Disability Index (SPADI) Total Disability score calculated as visit score - baseline score.
The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain, where: 0 = no pain and 10 = the worst pain imaginable. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use, where: 0 = no difficulty and 10 = so difficult it requires help.
Scoring instructions: The scores from both dimensions are averaged to derive a total score."|Baseline and 12 weeks|The As Treated analysis population included all subjects that received treatment and had outcome data.||units on a scale||Standard Error|Least Squares Mean
847830|NCT00436969|Secondary|Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 12 Weeks (Per Protocol)|"The difference in Shoulder Pain and Disability Index (SPADI) Total Disability score calculated as visit score - baseline score.
The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain, where: 0 = no pain and 10 = the worst pain imaginable. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use, where: 0 = no difficulty and 10 = so difficult it requires help.
Scoring instructions: The scores from both dimensions are averaged to derive a total score."|Baseline and 12 weeks|The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation. Subjects were allowed to have missing interim visits (i.e. 12 weeks).||units on a scale||Standard Error|Least Squares Mean
847831|NCT00436969|Secondary|American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 6 Months (As Treated)|"The difference in American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient score calculated as visit score - baseline score.
The ASES was designed to provide a standard method for evaluation of the shoulder through assessment of pain and activities of daily living (ie, function). The ASES is derived from an equation that incorporates a visual analog pain scale and functional ability questions. Both components have a maximum score of 50. Pain is calculated by subtracting the visual analog score from 10 and then multiplying by 5 for a total of 50 points. The function component is calculated by adding the points and multiplying by five thirds for a maximum of 50 points. The subscores for pain and function are then added for the total score. The maximum possible total score is 100, representing less pain and greater function."|Baseline and 6 months|The As Treated analysis population included all subjects that received treatment and had outcome data.||units on a scale||Standard Error|Least Squares Mean
847832|NCT00436969|Secondary|American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 6 Months (Per Protocol)|"The difference in American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient score calculated as visit score - baseline score.
The ASES was designed to provide a standard method for evaluation of the shoulder through assessment of pain and activities of daily living (ie, function). The ASES is derived from an equation that incorporates a visual analog pain scale and functional ability questions. Both components have a maximum score of 50. Pain is calculated by subtracting the visual analog score from 10 and then multiplying by 5 for a total of 50 points. The function component is calculated by adding the points and multiplying by five thirds for a maximum of 50 points. The subscores for pain and function are then added for the total score. The maximum possible total score is 100, representing less pain and greater function."|Baseline and 6 months|The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation.||units on a scale||Standard Error|Least Squares Mean
847833|NCT00436969|Secondary|American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 12 Weeks (As Treated)|"The difference in American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient score calculated as visit score - baseline score.
The ASES was designed to provide a standard method for evaluation of the shoulder through assessment of pain and activities of daily living (ie, function). The ASES is derived from an equation that incorporates a visual analog pain scale and functional ability questions. Both components have a maximum score of 50. Pain is calculated by subtracting the visual analog score from 10 and then multiplying by 5 for a total of 50 points. The function component is calculated by adding the points and multiplying by five thirds for a maximum of 50 points. The subscores for pain and function are then added for the total score. The maximum possible total score is 100, representing less pain and greater function."|Baseline and 12 weeks|The As Treated analysis population included all subjects that received treatment and had outcome data.||units on a scale||Standard Error|Least Squares Mean
847834|NCT00436969|Secondary|American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 12 Weeks (Per Protocol)|"The difference in American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient score calculated as visit score - baseline score.
The ASES was designed to provide a standard method for evaluation of the shoulder through assessment of pain and activities of daily living (ie, function). The ASES is derived from an equation that incorporates a visual analog pain scale and functional ability questions. Both components have a maximum score of 50. Pain is calculated by subtracting the visual analog score from 10 and then multiplying by 5 for a total of 50 points. The function component is calculated by adding the points and multiplying by five thirds for a maximum of 50 points. The subscores for pain and function are then added for the total score. The maximum possible total score is 100, representing less pain and greater function."|Baseline and 12 weeks|The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation. Subjects were allowed to have missing interim visits (i.e. 12 weeks).||units on a scale||Standard Error|Least Squares Mean
847835|NCT00436969|Secondary|Visual Analog Scale (VAS) Pain Score Change From Baseline and 12 Weeks (As Treated)|"Scores are measured on a 100 mm Visual Analog Scale (VAS). The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain.
The difference in pain was calculated as visit score - baseline score."|Baseline and 12 weeks|The As Treated analysis population included all subjects that received treatment and had outcome data.||mm on a 100 mm VAS scale||Standard Error|Least Squares Mean
847837|NCT00436969|Secondary|Percentage of Responders Using the Visual Analog Scale (VAS) Pain Score (As Treated)|"Scores are measured on a 100 mm Visual Analog Scale (VAS). The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain.
A responder was defined as a 20 mm or greater reduction in VAS pain score from baseline to 6 months."|Baseline and 6 months|The As Treated analysis population included all subjects that received treatment and had outcome data.||Percentage of Participants||95% Confidence Interval|Number
847838|NCT00436969|Secondary|Percentage of Responders Using the Visual Analog Scale (VAS) Pain Score (Per Protocol)|"Scores are measured on a 100 mm Visual Analog Scale (VAS). The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain.
A responder was defined as a 20 mm or greater reduction in VAS pain score from baseline to 6 months."|Baseline and 6 months|The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation.||Percentage of Participants||95% Confidence Interval|Number
847839|NCT00436969|Primary|Visual Analog Scale (VAS) Pain Score (Per Protocol)|Scores are measured on a 100 mm Visual Analog Scale (VAS). The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain.|6 Months|The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation.||mm on a 100 mm VAS scale||Standard Error|Least Squares Mean
847840|NCT00430950|Secondary|Number of Participants Achieving Blood Pressure Goal.||8 weeks|||participants|||Number
847841|NCT00430950|Secondary|Change in Daytime, Nighttime and 24-hour Blood Pressure Evaluated by Ambulatory Blood Pressure Monitoring 8 Weeks After Baseline.|Change = Week 16 - Week 8 (baseline).|8 weeks|Exploratory analysis: ANCOVA was used to compare the differences in change from baseline (Visit 4, Week 8) to Week 16 (Visit 6) in daytime, nighttime and 24-hr ABPM dBP and sBP.||mm Hg||Standard Deviation|Mean
847842|NCT00430950|Secondary|Change in Sitting Systolic Blood Pressure 4 Weeks and 8 Weeks After Baseline.|4 weeks Change = Week 12 - Week 8 (baseline). 8 weeks Change = Week 16 - Week 8 (baseline).|8 weeks|||mm Hg||Standard Deviation|Mean
847843|NCT00430950|Secondary|Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 12|Change = Week 12 - Week 8 (baseline).|4 weeks|||mm Hg||Standard Deviation|Mean
847844|NCT00430950|Primary|Change in Mean Trough Sitting Diastolic Blood Pressure|"Change in mean trough sitting diastolic Blood Pressure between OM/HCTZ 20/25 mg vs. 40/25 mg, in those patients inadequately controlled on OM 40 mg monotherapy, after eight weeks of double blind treatment, as compared to baseline.
Change = Week 16 - Week 8 (baseline)."|8 weeks|The main analysis will be performed on the full analysis set last observation carried forward (LOCF). Pooling will be applied for small centres.||mm Hg||Standard Deviation|Mean
847845|NCT00424554|Secondary|MGMT Activity in the Brain Tumor Tissues by Temozolomide Levels|No data available: at the time of tumor collection, the temozolomide levels were below the detection limits of the assay.|14 days||||||
847846|NCT00424554|Secondary|Concentrations of Temozolomide in the Serum, Cerebrospinal Fluid, and Brain Tumor|No data available: at the time of tumor collection, the temozolomide levels were below the detection limits of the assay.|14 days||||||
847847|NCT00424554|Secondary|Tolerability: Number of Participants Discontinuing Treatment Due to Adverse Events (AE)|An AE was defined as any event which was adverse, including what were commonly described as adverse or undesirable experiences, adverse events, adverse reactions, side effects, or death due to any cause associated with, or observed in conjunction with the use of a drug, biological product, or device in humans, whether or not considered related to the use of that product. Additionally, any event which was associated with, or observed in conjunction with product overdose whether accidental or intentional, or product abuse and/or withdrawal was also considered an AE.|12 months|||participants|||Number
847848|NCT00424554|Secondary|Safety: Number of Participants Who Experienced Grade 3 or 4 Toxicities|"Grade 3 was defined as severe per Common Terminology Criteria for Adverse Events (CTCAE).
Grade 4 was defined as life-threatening per CTCAE."|12 months|||participants|||Number
847849|NCT00424554|Primary|MethylGuanine-DNA MethylTransferase [MGMT] Activity Measured From the Tumor Tissue During Surgery|An experimental assay was developed to measure MGMT levels.|14 days|"All participants for which a MGMT activity assay could be
performed"||fmol/mg of proteins||Standard Deviation|Mean
847850|NCT00409539|Secondary|To Assess the Safety and Tolerability of 20, 40, 80 and 120 mg SMP 986 (o.d) Following 8-weeks of Treatment in Patients With Over Active Bladder Syndrome|Treatment emergent adverse event summary|8 Weeks|||participants|||Number
847851|NCT00409539|Primary|Change From Baseline to Week 8 in the Number of Voids/24 Hours||8 Weeks|||voids/24 hrs.||Standard Error|Least Squares Mean
847852|NCT00404547|Secondary|Assessment of Patient Treatment Satisfaction||12 weeks||||||
847853|NCT00404547|Secondary|Assessment of Patient Compliance During the Study||12 weeks||||||
847854|NCT00404547|Secondary|Change in Patient Assessment of Asthma Control|"Patient assessment of asthma control was assessed at baseline and at week 12 using the question How would you rate the control of your asthma symptoms?. The change in this assessment was categorized in Improvement and Non-Improvement."|At baseline and at week 12|Basis is the ITT population||participants|||Number
847855|NCT00404547|Primary|Change in Mean of Total Score of Asthma Control Questionnaire (ACQ)|The score of the change from baseline ranges from –6 (=best possible outcome) to 6 (=worst possible outcome).|At the middle and end of the 12 week treatment period|Basis is the ITT population||points on a scale||Standard Deviation|Mean
847856|NCT00402168|Secondary|Participants Who Switched to Belatacept in Long Term Period: Number of Participants With AEs and SAEs|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Day of Switch = the first belatacept infusion day.|Day of Switch (first dose of belatacept ) to last dose plus 56 days, up to Year 6 of the Study|All randomized and treated participants who switched from CNI to belatacept during the long-term period were summarized.||participants|||Number
848715|NCT00602836|Secondary|Number of Participants With IgVH Testing at Baseline Who Also Had a Clinical Response (CR, nPR, or PR).|Response categories described in above outcome measures. IgVH mutation status describe in baseline characteristics section.|During treatment (up to 5 years)||||||
847857|NCT00402168|Secondary|Participants Who Switched From CNI to Belatacept in Long Term Period : Mean Change in Calculated GFR Based on Imputed Values From Day of Switch to Week 96 Post Switch|Calculated GFR assessment used the MDRD formula. GFR was measured as mL/min/1.73 m^2. For death or graft loss participants, calculated GFR (cGFR) value 10 was used, for other participants who had a post baseline cGFR value missing, but had baseline value and at least 2 post baseline values available, which were at least 120 days apart, linear regression model was used to impute the cGFR value. Day of Switch = the first belatacept infusion day.|Day of Switch (first belatacept dose) to Week 96 Post Switch|All randomized and treated participants who switched from CNI to belatacept during the long-term period were summarized. n=number of participants with data available at specific time point||mL/min/1.73 m^2||Standard Deviation|Mean
847858|NCT00402168|Secondary|Long Term Period: Mean Change From Baseline to Month 54 in Diastolic Blood Pressure|Blood pressure was measured while the participant was sitting quietly for 5 minutes and was measured in mmHg. Baseline was value at screening. Only those participants who entered long term period were evaluated.|Baseline, Months 6, 12, 18, 24, 30, 36, 42, 48, 54|All participants who received at least 1 dose of study drug, were randomized to their original treatment arm, who entered the LT Period (ITT - LT), and had laboratory values were analyzed. Participants were grouped according to the treatment to which they were randomized (belatacept or CNI). n=entered LT Period with laboratory value available.||mmHg||Standard Deviation|Mean
847859|NCT00402168|Secondary|Long Term Period: Mean Change From Baseline to Month 54 in Systolic Blood Pressure|Blood pressure was measured while the participant was sitting quietly for 5 minutes and was measured in millimeters of mercury (mmHg). Baseline was value at screening. Only those participants who entered long term period were evaluated.|Baseline, Months 6, 12, 18, 24, 30, 36, 42, 48, 54|All participants who received at least 1 dose of study drug, were randomized to their original treatment arm, who entered the LT Period (ITT - LT), and had laboratory values were analyzed. Participants were grouped according to the treatment to which they were randomized (belatacept or CNI). n=entered LT Period with laboratory value available.||mmHg||Standard Deviation|Mean
847860|NCT00402168|Secondary|Long Term Period: Number of Participants Meeting Marked Laboratory Abnormality Criteria - All ITT Participants Who Entered the Long Term Period|Upper limits of normal (ULN). Hemoglobin: < 8 g/dL; Platelet count: < 50*10^9 c/L; Leukocytes: < 2.0*10^3 c/µL; Lymphocytes (absolute): < 0.5*10^3 c/µL; Neutrophils: < 1.0*10^3 c/µL; Alanine Aminotransferase (ALT): > 5.0*ULN Units per liter (U/L); bilirubin: > 3.0*ULN mg/dL; Creatinine: > 3.0*ULN mg/dL; Calcium: < 7 mg/dL; Bicarbonate: > 12.5 mg/dL; Potassium: < 3.0 meq/L or > 6.0 meq/L; Magnesium >2.6 meq/L; Sodium: < 130 meq/L; Phosphorus: < 2.0 mg/dL; Uric Acid: > 10 mg/dL.|Baseline (Screening), up to Year 6 of the Study|All participants who received at least 1 dose of study drug, were randomized to their original treatment arm, who entered the LT Period (ITT - LT), and had laboratory values were analyzed. Participants were grouped according to the treatment to which they were randomized (belatacept or CNI). n=entered LT Period with laboratory value available.||participants|||Number
847861|NCT00402168|Secondary|Long Term Period: Mean Change From Baseline to Month 54 in Serum Creatinine- ITT Participants Who Entered LT Period|Baseline was value at screening. Serum creatinine was measured in mg/dL. Only participants who entered into Long Term Period were included in the analysis.|Baseline, Months 3, 6, 12, 18, 24, 30, 36, 42, 48, 54|All participants who received at least 1 dose of study drug, were randomized to their original treatment arm, who entered the LT Period (ITT - LT), and had laboratory values were analyzed. Participants were grouped according to the treatment to which they were randomized (belatacept or CNI). n=entered LT Period with laboratory value available.||mg/dL||Standard Deviation|Mean
847862|NCT00402168|Secondary|Long Term Period: Number of Participants With AEs of Special Interest - All Randomized Participants Who Entered the Long Term Period|Prospectively identified events of special interest which were a subset of all AEs, and were either SAEs or non-serious AEs, included the following categories: Serious Infections, Thrombolic/embolic events, Autoimmune Disease, Malignancy, Peri-infusional reactions (only belatacept treatment group was IV) , Acute Peri-infusional events occurring within 24 hours of injection, Pulmonary Edema and Congestive Heart Failure. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|First dose after randomization (Day 1) to last dose, plus 56 days, up to Year 6 of the Study|All participants who received at least 1 dose of study drug, were randomized to their original treatment arm, and who entered the LT Period (ITT - LT) were analyzed. Participants were grouped according to the treatment to which they were randomized (belatacept or CNI).||participants|||Number
847863|NCT00402168|Secondary|Long Term Period: Number of Participants With SAEs, Death, Discontinuation Due to AEs - All Randomized Participants Who Entered the Long Term Period|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug.|First dose after randomization (Day 1) to 56 days post last dose, up to Year 6 of the Study|All participants who received at least 1 dose of study drug, were randomized to their original treatment arm, and who entered the LT Period (ITT - LT) were analyzed. Participants were grouped according to the treatment to which they were randomized (belatacept or CNI).||participants|||Number
847864|NCT00402168|Secondary|Long Term Period: Percentage of Participants With New Onset Diabetes Mellitus Up to Month 36- All Randomized Participants Who Entered LT Period|A participant who did not have diabetes prior to randomization is determined to have new onset diabetes mellitus if they received an antidiabetic medication for a duration of at least 30 days or at least two fasting plasma glucose (FPG) tests indicated that FPG is >=126 mg/dL. Percentage was the number of participants with new onset of diabetes mellitus divided by the number of participants without pre-randomization diabetes.|Baseline (screening) up to Month 36 post randomization|Participants without pre-randomization diabetes, who were randomized and entered LT Period.||percentage of participants||95% Confidence Interval|Number
847865|NCT00402168|Secondary|Long Term Period: Number of Participants Who Survived With a Functioning Graft or Survived With Pure Graft Loss or Death With Functioning Graft - ITT Participants Who Entered the LT Period|Graft loss = either pure graft loss (participant survived to the end of the study period after graft loss) or death with functioning graft. Pure graft loss = either functional loss or physical loss. Functional loss = a sustained level of serum creatinine (SCr) ≥ 6.0 mg/dL (530 μmol/L) for ≥ 4 weeks or administration of a maintenance dialysis regimen for at least 56 days or impairment of renal function to such a degree that the participant undergoes re-transplantation. The table was designed with built-in redundancy to capture all possible combinations of death and/or graft loss, but not all lines can be summed to reach the total number surviving and the total number who die and/or lose grafts. If a participant experiences pure graft loss and dies at a later date independent of the graft loss event, they are counted only once in the cumulative tabulation of death or graft loss. Only the first event experienced by the participant counted toward the cumulative total.|Post Months 24, 36, 48, up to Year 6 of the Study|Participants, randomized to their original treatment arm, who entered the LT Period (ITT - LT) were analyzed. Participants were grouped according to the treatment to which they were randomized (belatacept or CNI).||participants|||Number
847866|NCT00402168|Secondary|Long Term Period: Number of Participants With Acute Rejection (AR) - All Randomized Participants in LT Period|AR was defined: if either a or b was satisfied: (a) the reason for clinical suspicion was reported to be an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; or an unexplained decreased urine output; or fever and graft tenderness and the episode was a case of biopsy proven AR (AR of Banff histopathologic classification grade IA or higher as assessed by the blinded central pathologist); (b) the reason for clinical suspicion was reported to be something other than: an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; or an unexplained decreased urine output; or fever and graft tenderness; the episode was a case of biopsy proven AR, and the participant was treated for this episode. Banff 97 working classification of kidney transplant pathology was used to categorize the severity of the AR.|Post Month 12 up to Year 6 of the Study|Participants, randomized to their original treatment arm, who entered the LT Period (ITT - LT) were analyzed. Participants were grouped according to the treatment to which they were randomized (belatacept or CNI).||participants|||Number
847867|NCT00402168|Secondary|Long Term Period: Mean Change From Baseline to 54 Months Post Randomization in Calculated GFR on Imputed Values at Specified Timepoints - Intent to Treat (ITT) Participants Who Entered LT Period|ITT=participants randomized to their original treatment arm and who entered the LT period are presented. Baseline=value at screening. Calculated GFR assessment used the MDRD formula. GFR was measured as mL/min/1.73 m^2. For death or graft loss participants, calculated GFR (cGFR) value of 0 was imputed and carried forward after death or graft loss up to the end of the analysis period. Sponsor discontinued the CNI treatment arm in Year 3, and participants treated with CNI could elect to switch to belatacept. If a participant did not switch to belatacept, they were required to discontinue from the study. Therefore, efficacy results from Month 36 through Month 54 are difficult to interpret. No formal comparisons were planned between the belatacept and CNI treatment groups post Month 36, and the data up to the final database lock should be interpreted with caution.|Baseline, Month 3, 6, 12, 18, 24, 30, 36, 42, 48, 54|Participants randomized to their original treatment arm who entered the LT Period (ITT - LT) and had data at baseline and at specific timepoints . Participants were grouped according to the treatment to which they were randomized (belatacept or CNI).||mL/min/1.73 m^2||Standard Deviation|Mean
847868|NCT00402168|Secondary|Number of Participants Meeting Marked Laboratory Abnormality Criteria From Baseline up to Month 12 - Randomized and Treated Participants|Upper limits of normal (ULL). Leukocytes: < 2.0*10^3 cells per microliter (c/µL); Lymphocytes (absolute): < 0.5*10^3 c/µL; bilirubin: > 3.0*ULN milligrams per deciliter (mg/dL); Potassium: < 3.0 milliequivalents per liter (meq/L) or > 6.0 meq/L; Magnesium >2.6 meq/L; Sodium: < 130 meq/L; Phosphorus: < 2.0 mg/dL; Uric Acid: > 10 mg/dL. Baseline = value at screening.|Baseline up to Month 12|All randomized participants who received at least one dose of study drug and had a laboratory value available post randomization. N= number of participants analyzed in all categories||participants|||Number
847869|NCT00402168|Secondary|Ridit Score at Month 12 - All Randomized Participants|The Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSD-59R) was used to assess the occurrence (never, occasionally, regularly, almost always, always) and distress (0=no distress to 4=terrible distress) of symptoms associated with immunosuppressive therapies. Ridit (relative to an identified distribution) analysis (Fleiss JL. Statistical methods for rates and proportions. New York: John Wiley & Sons, Inc. 1991) was used. Ridit scores were calculated at 12 months for overall symptom occurrence score and overall symptom distress. The Ridit score reflects the probability that a score observed for an individual randomly selected from a group would be higher (worse symptom) than a score observed for a randomly selected individual from the reference group. The reference group was constituted by the frequency distribution of the responses of all participants on all items at baseline. The ridit of the reference group is by definition, 0.5.|Month 12|All randomized participants with MTSOSD-59R data were analyzed.||Ridit score|||Number
847870|NCT00402168|Secondary|Mean Change From Baseline to Month 12 for Eight Domain Scores of Quality of Life (QoL) Instrument SF-36 - All Randomized Participants|"SF-36 was a Participant-Reported Quality of Life (QoL) Short Form (SF) questionnaire measuring health-related quality of life (HRQL) covering 8 domains of physical and mental component summaries: physical function, role limitations due to physical problems, pain, general health perception, and vitality, social function, role limitations due to emotional problems, and mental health.
All domains were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life."|Baseline (screening) to Month 12|Randomized participants with available questionnaires were analyzed.||units on a scale||Standard Error|Mean
847897|NCT00395135|Primary|Year 1: Co-Primary Endpoint- Proportion (%) of Patients Achieving > or = 5% Weight Loss From Baseline to Week 52|"The proportion of patients with a reduction from baseline body weight of 5% or more at the end of year 1.
Other co-primary endpoints are change from baseline in body weight (kg) at year 1 and the proportion of patients achieving ≥ 10% reduction in body weight at year 1."|52 weeks|MITT with LOCF||percentage of participants|||Number
847871|NCT00402168|Secondary|Mean Change From Baseline in SF-36 Questionnaire Physical Component Score and in Mental Component Score at Month 12 - All Randomized Participants|SF-36 was a Participant-Reported Quality of Life (QoL) Short Form (SF) questionnaire. The subscale in the mental component (MCS) part of the instrument ranged from 1 to 6 with 1=all of the time and 6= none of the time. The subscale for physical component (PCS) ranged from 1 to 3 with 1=Yes, limited a lot and 3=No, not limited at all. The subscale for the extent that physical health or emotional problems interfered with normal activities ranged from 1 to 5 with 1=not at all and 5= extremely. Baseline was at randomization or prior to first dose. Baseline = value at screening. The subscale scores were transformed using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life.|Baseline, Month 12|All randomized participants who completed the questionnaire at baseline and at Month 12.||units on a scale||Standard Error|Mean
847872|NCT00402168|Secondary|Number of Participants With Serious Adverse Events (SAEs), Deaths, and Discontinuation Due to Adverse Events (AEs) From First Dose up to Month 12|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug.|First Dose (Day 1) to Month 12|All randomized participants who received at least 1 dose of study drug were summarized.||participants|||Number
847873|NCT00402168|Secondary|Mean Change From Baseline to Month 6 and to Month 12 in Serum Creatinine - All Randomized Participants|Baseline was value at screening or prior to first dose of study drug. Serum creatinine was measured in milligrams per deciliter (mg/dL). Baseline = value at screening.|Baseline to Month 6 and Month 12 Post Randomization|All randomized participants with baseline and laboratory value at specific time point were summarized.||mg/dL||Standard Deviation|Mean
847874|NCT00402168|Secondary|Number of Participants With Anti-Donor Human Leukocyte Antigen (HLA) Positive Antibodies|Samples were obtained at Day 1 (first dose), Week 24, and Week 52 (or end of therapy). This was a cumulative summary in that once a participant was positive, that participant remained positive for later time points. Evaluation of anti-donor HLA antibodies was performed by an external laboratory (Emory University, Atlanta, Georgia).|Month 6 and Month 12 Post Randomization|Participants who had at least one test result or finding were summarized. n=number of participants analyzed at each specific time point.||participants|||Number
847875|NCT00402168|Secondary|Percentage of Participants With New Onset Diabetes Mellitus - All Randomized Participants|A participant who did not have diabetes prior to randomization is determined to have new onset diabetes mellitus if they received an antidiabetic medication for a duration of at least 30 days or at least two fasting plasma glucose (FPG) tests indicated that FPG is >=126 mg/dL. Percentage was the number of participants with new onset of diabetes mellitus divided by the number of participants without pre-randomization diabetes.|Month 12 post randomization|Participants without pre-randomization diabetes.||percentage of participants||95% Confidence Interval|Number
847876|NCT00402168|Secondary|Percentage of Participants With a Composite Endpoint of Death, Graft Loss and Acute Rejection at Month 12|Percentage=number with composite divided by number randomized. Graft loss was functional loss or physical loss. Functional loss = sustained level of serum creatinine (SCr) ≥ 6.0 mg/dL for ≥ 4 weeks or administration of a maintenance dialysis regimen for at least 56 days or impairment of renal function to such a degree that participant undergoes re-transplantation. AR: if either a or b: (a) the reason for clinical suspicion was reported to be an unexplained rise of serum creatinine ≥ 25% from baseline; or an unexplained decreased urine output; or fever and graft tenderness and the episode was a case of biopsy-proven AR (grade IA or higher as assessed by the blinded central pathologist); (b) the reason for clinical suspicion was reported to be something other than: an unexplained rise of serum creatinine ≥ 25% from baseline; or an unexplained decreased urine output; or fever and graft tenderness; the episode was a case of biopsy-proven AR, and the participant was treated for it.|12 Months post randomization|All participants who were randomized were analyzed.||percentage of participants||95% Confidence Interval|Number
847877|NCT00402168|Primary|Mean Change From Baseline in Calculated Glomerular Filtration Rate (GFR) With Imputed Values to 12 Months Post Randomization - All Randomized Participants (Intent-to-Treat Population)|Calculated GFR assessment used the modification of diet in renal disease (MDRD) formula. GFR was measured as mL/min/1.73 m^2. For death or graft loss participants, calculated GFR (cGFR) value 10 was used, for other participants who had a post baseline cGFR value missing, but had baseline value and at least 2 post baseline values available, which were at least 120 days apart, linear regression model was used to impute the cGFR value. Baseline = value at screening. Randomization/First Dose was on Day 1.|Baseline to 12 months post randomization|Intent-to-Treat (ITT) population: all randomized participants with available data were analyzed.||mL/min/1.73 m^2||Standard Deviation|Mean
847878|NCT00402168|Secondary|Number of Participants Who Had Any Study Drug Dose Alteration by Month 12 Due to Any Reason - Randomized and Treated Participants|Reasons for study drug dose modification included categories of decline in renal function (as determined by the investigator), treatment of acute rejection, and other reasons. More than 1 reason could be given for dose alteration.|Month 12|Participants who were randomized and received at least one dose of any study drug.||participants|||Number
847879|NCT00402168|Secondary|Percentage of Participants Surviving With a Functioning Graft, Have Graft Loss or Death (Graft Loss, Death, Death With Functioning Graft) By Month 6 and Month 12 Post Randomization|Graft loss was defined as either functional loss or physical loss. Functional loss was defined as a sustained level of serum creatinine (SCr) ≥ 6.0 mg/dL (530 μmol/L) for ≥ 4 weeks or administration of a maintenance dialysis regimen for at least 56 days or impairment of renal function to such a degree that the participant undergoes re-transplantation.|At 6 and 12 months post randomization|All participants who were randomized were summarized.||percentage of participants|||Number
847908|NCT00379821|Secondary|Mean Alanine Transaminase (ALT) in Each Treatment Arm (Hepatic Function)|ALT values were assessed from blood draws at Day 0 and Day 14 of each malaria episode.|Day 0 of fourth subsequent malaria episode (Episode 4)|The safety population includes all participants who have laboratory results reported at the time point for the episode.||International Units/Liter||95% Confidence Interval|Mean
847880|NCT00402168|Secondary|Number of Participants With Acute Rejection (AR) by Months 6 and 12 Post Randomization - All Randomized Participants|AR defined: if either a or b was satisfied: a: the reason for clinical suspicion was reported to be an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; or an unexplained decreased urine output; or fever and graft tenderness and the episode was a case of biopsy proven AR (AR of Banff histopathologic classification Grade IA or higher as assessed by the blinded central pathologist); b: the reason for clinical suspicion was reported to be something other than: an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; or an unexplained decreased urine output; or fever and graft tenderness; the episode was a case of biopsy proven AR, and the participant was treated for this episode. Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. AR is defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection.|At 6 and 12 months post randomization|ITT population: All randomized participants were summarized. N=number analyzed for Months 6 and 12||participants|||Number
847881|NCT00402168|Secondary|Mean Change From Baseline in Calculated Glomerular Filtration Rate (GFR) With Imputed Values to 6 Months Post Randomization - All Randomized Participants (Intent-to-Treat Population)|Calculated GFR assessment used the modification of diet in renal disease (MDRD) formula. GFR was measured as mL/min/1.73 m^2. For death or graft loss participants, calculated GFR (cGFR) value 10 was used, for other participants who had a post baseline cGFR value missing, but had baseline value and at least 2 post baseline values available, which were at least 120 days apart, linear regression model was used to impute the cGFR value. Baseline = value at screening.|Baseline to 6 months post randomization|Intent-to-Treat (ITT) population: all randomized participants with available data were analyzed.||mL/min/1.73 m^2||Standard Deviation|Mean
847882|NCT00396006|Secondary|Clinically Significant Changes in Vital Signs From Pre- to Post-Infusion|"Clinically significant changes in vital signs from pre- to post-infusion are:
Heart rate: 25% increase above pre-infusion value
Blood pressure: ≥ 30 mm Hg change from pre-infusion blood pressure (systolic or diastolic)
Temperature: an increase in body temperature to >38°C (>100.4°F). If the pre-infusion body temperature was already >38°C (>100.4°F), then any further increase in body temperature by 1.1°C (1.98°F) or more was considered clinically significant.
Respiratory rate: 25% increase above pre-infusion value"|During 8 consecutive weeks of infusion|Intention to treat||# Clinically significant events|||Number
847883|NCT00396006|Primary|Number of Changes in the Rate of Infusion|Number of decreases in the rate or discontinuations of infusion at 0.2 mL/kg/min|During 8 consecutive weeks of treatment|||infusions|||Number
847884|NCT00396006|Other Pre-specified|Change in the BAL ELF Tumor Necrosis Factor-alpha (TNF-α) From Baseline to Post-treatment|Median change in the BAL ELF TNF-α from baseline to post-treatment|BAL procedures were performed at baseline and after 8 consecutive weeks of treatment (minimum of 12 weeks)|Per protocol population with both pre- and post-treatment analytes available from BAL procedures|||||
847885|NCT00396006|Other Pre-specified|Ratio of Post- to Pre-treatment BAL ELF Interleukin 8 (IL-8) Level|Median ratio of post- to pre-treatment BAL ELF IL-8 Level|BAL procedures were performed at baseline and after 8 consecutive weeks of treatment (minimum of 12 weeks)|Per protocol||pg/mL||Full Range|Median
847886|NCT00396006|Other Pre-specified|Ratio of Post- to Pre-treatment BAL ELF Total Neutrophil Elastase Level|Median ratio of post- to pre-treatment BAL ELF Total Neutrophil Elastase Level|BAL procedures were performed at baseline and after 8 consecutive weeks of treatment (minimum of 12 weeks)|Per protocol||nM||Full Range|Median
847887|NCT00396006|Other Pre-specified|Change in the BAL ELF Free Neutrophil Elastase Level|Median change in the BAL ELF Free Neutrophil Elastase Level from baseline to post-treatment|BAL procedures were performed at baseline and after 8 consecutive weeks of treatment (minimum of 12 weeks)|Per protocol population with both pre- and post-treatment analytes available from BAL procedures||nM||Full Range|Median
847888|NCT00396006|Secondary|Change in the Plasma Antineutrophil Elastase Capacity (ANEC) Level|Mean change in the plasma ANEC level from baseline to post-treatment|Blood samples were collected at baseline and after 8 consecutive weeks of treatment|Per protocol||μM||Standard Deviation|Mean
847889|NCT00396006|Secondary|Change in the α1-PI Plasma Level|Mean change in the plasma level of α1-PI from baseline to post-treatment|Blood samples were collected at baseline and after 8 consecutive weeks of treatment|Per protocol||μM||Standard Deviation|Mean
847890|NCT00396006|Secondary|Change in in the Ratio of BAL ELF α1-PI to Human Neutrophil Elastase (HNE) Complex Concentration|Median change in the ratio of BAL ELF α1-PI to HNE complex concentration from baseline to post-treatment|BAL procedures were performed at baseline and after 8 consecutive weeks of treatment (minimum of 12 weeks)|No per protocol subject had both pre- and post-treatment analytes available, therefore no analysis could be performed on this outcome measure|||||
847891|NCT00396006|Secondary|Ratio of Post- to Pre-treatment BAL ELF Antineutrophil Elastase Capacity (ANEC) Levels|Median ratio of post- to pre-treatment BAL ELF ANEC levels|BAL procedures were performed at baseline and after 8 consecutive weeks of treatment (minimum of 12 weeks)|Per protocol||μM||Full Range|Median
847892|NCT00396006|Primary|The Number of Adverse Events (AEs) Related to the Infusion of ARALAST Fr. IV 1 Administered at a Rate of 0.2 mL/kg/Min||During 8 consecutive weeks of treatment|Intent to treat||adverse events|||Number
847893|NCT00396006|Primary|Change in Bronchoalveolar Lavage (BAL) Epithelial Lining Fluid (ELF) Alpha1-Proteinase Inhibitor (α1-PI) Level|Median change BAL ELF antigenic α1-PI level the from baseline to post-treatment|BAL procedures were performed at baseline and after 8 consecutive weeks of treatment (minimum of 12 weeks)|Per protocol||μM||Full Range|Median
847894|NCT00395135|Secondary|Year 2: Percent Change in Body Weight From Week 52 to Week 104|Year 2: The % change in body weight (kg) from week 52 to week 104.|52 weeks|MITT with LOCF||% change from baseline: body wt (kg)||Standard Error|Least Squares Mean
847895|NCT00395135|Secondary|Year 1: Percent Change in Body Weight From Baseline to Week 52|Year 1: The % change in body weight (kg) from baseline to week 52.|52 weeks|MITT with LOCF||% change from baseline: body wt (kg)||Standard Error|Least Squares Mean
847896|NCT00395135|Primary|Year 2: Proportion (%) of Patients Maintaining > or = 5% Weight Loss at Week 104|The proportion of patients with a reduction from baseline body weight of 5% or more at the end of year 1 and who maintained this reduction during year 2.|104 weeks|MITT with LOCF||percentage of participants|||Number
847898|NCT00379821|Secondary|Pharmacokinetics of Chloroquine Represented by Maximum Concentration (Cmax)|1727 non-zero concentration measurements from 479 participants were pooled and used for population pharmacokinetic modeling in Monolix413s. Compartmental population pharmacokinetic modeling was used due to highly sparse data. The model was parameterized in terms of absorption rate constant for chloroquine (Ka), apparent clearance for chloroquine (CL/F, with F as the unknown oral bioavailability), apparent volume of distribution of the central and peripheral compartments for chloroquine (Vd/F), and the inter-compartmental clearance for chloroquine (Q/F). Only these primary population pharmacokinetic parameters could be estimated using the type of data collected. The best-fit population PK model was then used to estimate individual parameter estimates to derive Cmax in nanograms per milliliter (ng/mL).|Day 0 - Day 28|All participants with non-zero concentration measures suitable for pharmacokinetic analysis were included.||ng/mL chloroquine||95% Confidence Interval|Median
847899|NCT00379821|Secondary|Pharmacokinetics of Chloroquine Represented by Time of Maximal Concentration (Tmax) and Chloroquine Half-life|1727 non-zero concentration measurements from 479 participants were pooled and used for population pharmacokinetic modeling in Monolix413s. Compartmental population pharmacokinetic modeling was used due to highly sparse data. The model was parameterized in terms of absorption rate constant for chloroquine (Ka), apparent clearance for chloroquine (CL/F, with F as the unknown oral bioavailability), apparent volume of distribution of the central and peripheral compartments for chloroquine (Vd/F), and the inter-compartmental clearance for chloroquine (Q/F). Only these primary population pharmacokinetic parameters could be estimated using the type of data collected. The best-fit population PK model was then used to estimate individual parameter estimates to derive Tmax and half-life.|Day 0 - Day 28|All participants with non-zero concentration measures suitable for pharmacokinetic analysis were included.||Hours||95% Confidence Interval|Median
847900|NCT00379821|Secondary|Nearest Neighbor Index as a Measure of Spatial Pattern of the Distribution of Malaria Cases in Ndirande|The Global Positioning System (GPS) was used to establish the coordinates of participants' homes. The distribution of these coordinates was analyzed for evidence of clustering, or occurring closer together than would be expected on the basis of chance. Nearest Neighbor Index is a ratio of the observed mean distance over the expected mean distance. If the index is less than 1, the pattern exhibits clustering. If the index is greater than 1, the trend is toward dispersion.|1 year|The analysis included all participants for whom the GPS coordinates of the home were established.||Index|||Number
847901|NCT00379821|Secondary|Time to First Malaria Episode in Participants Who Travelled and Slept Outside the City Versus Those Who Did Not Travel and Sleep Outside the City.|The cumulative hazard of having a malaria attack within one year for those participants who travelled and slept in rural areas (outside the city) versus those who did not was calculated and is presented as a life table to display the number of subjects at risk, the number with first clinical episode and the number censored at each time point. Participants are right-censored at the time of first malaria episode. Participants who did not develop malaria during follow-up or were lost to follow-up were censored at the time of their last visit.|Days 0 - 420|||participants|||Number
847902|NCT00379821|Secondary|Number of Participants With New and Recrudescent Infections After Subsequent New Episodes|Participants were enrolled at the time of initial malaria episode and treated. Subsequent to treatment, participants who subsequently suffered new malaria episodes were monitored for the additional occurrence of new and recrudescent malaria infections, which were distinguished by analysis of the infecting parasites using merozoite surface protein-2 polymorphic gene length variation.|Day 28 to 1 year|The analysis population is limited to participants who had new episodes of malaria during the follow-up period after treatment.||participants|||Number
847903|NCT00379821|Secondary|Number of Participants With New and Recrudescent Malaria Infections After Initial Treatment|Participants were enrolled at the time of initial malaria episode and treated. Subsequent to treatment, subjects were monitored for the occurrence of new and recrudescent malaria infections, which were distinguished by analysis of the infecting parasites using merozoite surface protein-2 polymorphic gene length variation.|28 days to 1 year|All subjects completing the initial treatment were included in the analysis population.||participants|||Number
847904|NCT00379821|Secondary|Number of Participants Infected With Parasites With the Mutation Pfcrt 76T at Recrudescent Episodes of Malaria|Participants were enrolled in the study at the time of the initial episode of malaria. If the participant presented with a subsequent episode of malaria at any time during the one year of follow-up, the presence of parasites with the mutation pfCRT 76T was measured with filter paper specimens collected at the time of enrollment and with successful parasite DNA amplification using pyrosequencing.|Recrudescent episodes of malaria within one year of enrollment|The analysis population is limited to participants who presented with subsequent episodes of malaria from whom samples were successfully collected and DNA successfully amplified.||participants|||Number
847905|NCT00379821|Secondary|Number of Participants Infected With Parasites With the Mutation Pfcrt 76T on Day 0 of the Initial Episode of Malaria|The presence of parasites with the mutation pfCRT 76T was measured with filter paper specimens collected at the time of enrollment and with successful parasite DNA amplification using pyrosequencing.|Day 0 of initial episode of malaria|All participants from whom samples were successfully collected and DNA successfully amplified were included.||participants|||Number
847906|NCT00379821|Secondary|Number of Participants in Each Treatment Arm Who Change From “Normal” to “Abnormal” on Any Questions of the Neurological Examination|"A basic age-appropriate neurological examination was conducted on Day 28 of each malaria illness episode and also at Days 112 and 224, and at 1 year. Subjects were were counted as a change from 'normal' to 'abnormal'  if they had the 'normal' (or not-applicable) response for the initial day 28 exam and an 'abnormal' response at their last exam. If a subject did not have an exam at 1 year then the last available exam that was not associated with an illness episode (either Day 112 or 224) was used."|1 Year|Subjects who did not have an initial exam, or who did not have a subsequent exam at a routine visit are excluded.||Participants|||Number
847907|NCT00379821|Secondary|Mean Alanine Transaminase (ALT) in Each Treatment Arm (Hepatic Function)|ALT values were assessed from blood draws at Day 0 and Day 14 of each malaria episode.|Day 14 of fourth subsequent malaria episode (Episode 4)|The safety population includes all participants who have laboratory results reported at the time point for the episode.||International Units/Liter||95% Confidence Interval|Mean
847911|NCT00379821|Secondary|Mean Alanine Transaminase (ALT) in Each Treatment Arm (Hepatic Function)|ALT values were assessed from blood draws at Day 0 and Day 14 of each malaria episode.|Day 14 of second subsequent malaria episode (Episode 2)|The safety population includes all participants who have laboratory results reported at the time point for the episode.||International Units/Liter||95% Confidence Interval|Mean
847912|NCT00379821|Secondary|Mean Alanine Transaminase (ALT) in Each Treatment Arm (Hepatic Function)|ALT values were assessed from blood draws at Day 0 and Day 14 of each malaria episode.|Day 0 of second subsequent malaria episode (Episode 2)|The safety population includes all participants who have laboratory results reported at the time point for the episode.||International Units/Liter||95% Confidence Interval|Mean
847913|NCT00379821|Secondary|Mean Alanine Transaminase (ALT) in Each Treatment Arm (Hepatic Function)|ALT values were assessed from blood draws at Day 0 and Day 14 of each malaria episode.|Day 14 of first subsequent malaria episode (Episode 1)|The safety population includes all participants who have laboratory results reported at the time point for the episode.||International Units/Liter||95% Confidence Interval|Mean
847914|NCT00379821|Secondary|Mean Alanine Transaminase (ALT) in Each Treatment Arm (Hepatic Function)|ALT values were assessed from blood draws at Day 0 and Day 14 of each malaria episode.|Day 0 of first subsequent malaria episode (Episode 1)|The safety population includes all participants who have laboratory results reported at the time point for the episode.||International Units/Liter||95% Confidence Interval|Mean
847915|NCT00379821|Secondary|Mean Alanine Transaminase (ALT) in Each Treatment Arm (Hepatic Function)|ALT values were assessed from blood draws at Day 0 and Day 14 of each malaria episode.|Day 14 of initial malaria episode (Episode 0)|The safety population includes all participants who have laboratory results reported at the time point for the episode.||International Units/Liter||95% Confidence Interval|Mean
847916|NCT00379821|Secondary|Mean Alanine Transaminase (ALT) in Each Treatment Arm (Hepatic Function)|ALT values were assessed from blood draws at Day 0 and Day 14 of each malaria episode.|Day 0 of initial malaria episode (Episode 0)|The safety population includes all participants who have laboratory results reported at the time point for the episode.||International Units/Liter||95% Confidence Interval|Mean
847917|NCT00379821|Secondary|Mean Creatinine in Each Treatment Arm (Renal Function)|Creatine values were assessed from blood draws at Day 0 and Day 14 of each malaria episode. Samples that were below the limit of detection were reported as 44.2 micromoles/liter, equivalent to the lower limit of detection.|Day 14 of fourth subsequent malaria episode (Episode 4)|The safety population includes all participants who have laboratory results reported at the time point for the episode.||Micromole/Liter||95% Confidence Interval|Mean
847918|NCT00379821|Secondary|Mean Creatinine in Each Treatment Arm (Renal Function)|Creatine values were assessed from blood draws at Day 0 and Day 14 of each malaria episode. Samples that were below the limit of detection were reported as 44.2 micromoles/liter, equivalent to the lower limit of detection.|Day 0 of fourth subsequent malaria episode (Episode 4)|The safety population includes all participants who have laboratory results reported at the time point for the episode.||Micromole/Liter||95% Confidence Interval|Mean
847919|NCT00379821|Secondary|Mean Creatinine in Each Treatment Arm (Renal Function)|Creatine values were assessed from blood draws at Day 0 and Day 14 of each malaria episode. Samples that were below the limit of detection were reported as 44.2 micromoles/liter, equivalent to the lower limit of detection.|Day 14 of third subsequent malaria episode (Episode 3)|The safety population includes all participants who have laboratory results reported at the time point for the episode.||Micromole/Liter||95% Confidence Interval|Mean
847920|NCT00379821|Secondary|Mean Creatinine in Each Treatment Arm (Renal Function)|Creatine values were assessed from blood draws at Day 0 and Day 14 of each malaria episode. Samples that were below the limit of detection were reported as 44.2 micromoles/liter, equivalent to the lower limit of detection.|Day 0 of third subsequent malaria episode (Episode 3)|The safety population includes all participants who have laboratory results reported at the time point for the episode.||Micromole/Liter||95% Confidence Interval|Mean
847921|NCT00379821|Secondary|Mean Creatinine in Each Treatment Arm (Renal Function)|Creatine values were assessed from blood draws at Day 0 and Day 14 of each malaria episode. Samples that were below the limit of detection were reported as 44.2 micromoles/liter, equivalent to the lower limit of detection.|Day 14 of second subsequent malaria episode (Episode 2)|The safety population includes all participants who have laboratory results reported at the time point for the episode.||Micromole/Liter||95% Confidence Interval|Mean
847922|NCT00379821|Secondary|Mean Creatinine in Each Treatment Arm (Renal Function)|Creatine values were assessed from blood draws at Day 0 and Day 14 of each malaria episode. Samples that were below the limit of detection were reported as 44.2 micromoles/liter, equivalent to the lower limit of detection.|Day 0 of second subsequent malaria episode (Episode 2)|The safety population includes all participants who have laboratory results reported at the time point for the episode.||Micromole/Liter||95% Confidence Interval|Mean
847923|NCT00379821|Secondary|Mean Creatinine in Each Treatment Arm (Renal Function)|Creatine values were assessed from blood draws at Day 0 and Day 14 of each malaria episode. Samples that were below the limit of detection were reported as 44.2 micromoles/liter, equivalent to the lower limit of detection.|Day 14 of first subsequent malaria episode (Episode 1)|The safety population includes all participants who have laboratory results reported at the time point for the episode.||Micromole/Liter||95% Confidence Interval|Mean
847924|NCT00379821|Secondary|Mean Creatinine in Each Treatment Arm (Renal Function)|Creatine values were assessed from blood draws at Day 0 and Day 14 of each malaria episode. Samples that were below the limit of detection were reported as 44.2 micromoles/liter, equivalent to the lower limit of detection.|Day 0 of first subsequent malaria episode (Episode 1)|The safety population includes all participants who have laboratory results reported at the time point for the episode.||Micromole/Liter||95% Confidence Interval|Mean
847925|NCT00379821|Secondary|Mean Creatinine in Each Treatment Arm (Renal Function)|Creatine values were assessed from blood draws at Day 0 and Day 14 of each malaria episode. Samples that were below the limit of detection were reported as 44.2 micromoles/liter, equivalent to the lower limit of detection.|Day 14 of initial malaria episode (Episode 0)|The safety population includes all participants who have laboratory results reported at the time point for the episode.||Micromole/Liter||95% Confidence Interval|Mean
847926|NCT00379821|Secondary|Mean Creatinine in Each Treatment Arm (Renal Function)|Creatine values were assessed from blood draws at Day 0 and Day 14 of each malaria episode. Samples that were below the limit of detection were reported as 44.2 micromoles/liter, equivalent to the lower limit of detection.|Day 0 of initial malaria episode (Episode 0)|The safety population includes all participants who have laboratory results reported at the time point for the episode.||Micromole/Liter||95% Confidence Interval|Mean
847927|NCT00379821|Secondary|Mean Hemoglobin at the Last Study Visit in Each Treatment Arm for the Age Group of Participants Greater Than 3 Years to 5 Years of Age.|Hemoglobin values were assessed from blood collected at the last study visit at one year after enrollment. Group means are stratified by participants 3 years of age and under, and over 3 to 5 years of age.|1 year|The safety population includes all participants. The number of participants is limited to those who attended the final 1-year visit.||Grams/Deciliter||95% Confidence Interval|Mean
847928|NCT00379821|Secondary|Mean Hemoglobin at the Last Study Visit in Each Treatment Arm for the Age Group of Participants 3 Years of Age or Younger.|Hemoglobin values were assessed from blood collected at the last study visit at one year after enrollment. Group means are stratified by participants 3 years of age and under, and over 3 to 5 years of age.|1 year|The safety population includes all participants. The number of participants is limited to those who attended the final 1-year visit.||Grams/Deciliter||95% Confidence Interval|Mean
847929|NCT00379821|Secondary|Number of Cases of Severe Malaria in Each Treatment Arm|A case of severe malaria included one or more of the following: Hemoglobin ≤5 g/dL; prostration; respiratory distress; bleeding; recent seizures, coma or obtundation (Blantyre coma score < 5); inability to drink, or persistent vomiting. All cases were then adjudicated by a panel of investigators prior to analysis.|1 Year|The safety cohort includes all participants.||Cases of severe malaria|||Number
847930|NCT00379821|Secondary|Number of Participants With Day 28 Adequate Clinical and Parasitologic Response in Each Treatment Arm|Adequate clinical and parasitologic response (ACPR) was defined as the absence of parasitemia at Day 28 and without previously meeting any of the criteria of early treatment or late clinical failure.|Day 28 of fourth subsequent malaria episode (Episode 4)|This analysis was per protocol, which includes participants who had 4 subsequent malaria episodes, but excludes participants if the fourth episode was not caused by p. falciparum or if the participant did not receive all 3 doses of treatment for the fourth episode.||Participants|||Number
847931|NCT00379821|Secondary|Number of Participants With Day 28 Adequate Clinical and Parasitologic Response in Each Treatment Arm|Adequate clinical and parasitologic response (ACPR) was defined as the absence of parasitemia at Day 28 and without previously meeting any of the criteria of early treatment or late clinical failure.|Day 28 of third subsequent malaria episode (Episode 3)|This analysis was per protocol, which includes participants who had at least 3 subsequent malaria episodes, but excludes participants if the third episode was not caused by p. falciparum or if the participant did not receive all 3 doses of treatment for the third episode.||Participants|||Number
847932|NCT00379821|Secondary|Number of Participants With Day 28 Adequate Clinical and Parasitologic Response in Each Treatment Arm|Adequate clinical and parasitologic response (ACPR) was defined as the absence of parasitemia at Day 28 and without previously meeting any of the criteria of early treatment or late clinical failure.|Day 28 of second subsequent malaria episode (Episode 2)|This analysis was per protocol, which which includes participants who had at least 2 subsequent malaria episodes, but excludes participants if the second episode was not caused by p. falciparum or if the participant did not receive all 3 doses of treatment for the second episode.||Participants|||Number
847933|NCT00379821|Secondary|Number of Participants With Day 28 Adequate Clinical and Parasitologic Response in Each Treatment Arm|Adequate clinical and parasitologic response (ACPR) was defined as the absence of parasitemia at Day 28 and without previously meeting any of the criteria of early treatment or late clinical failure.|Day 28 of first subsequent malaria episode (Episode 1)|This analysis was per protocol, which includes participants who had at least 1 subsequent malaria episode, but excludes participants who did if that episode was not caused by p. falciparum or if the participant did not receive all 3 doses of treatment for the first subsequent episode.||Participants|||Number
847934|NCT00379821|Secondary|Number of Participants With Day 28 Adequate Clinical and Parasitologic Response in Each Treatment Arm|Adequate clinical and parasitologic response (ACPR) was defined as the absence of parasitemia at Day 28 and without previously meeting any of the criteria of early treatment or late clinical failure.|Day 28 of initial malaria episode (Episode 0)|This analysis was per protocol, which excludes participants who did not have p. falciparum or who did not receive all 3 doses of treatment.||Participants|||Number
847935|NCT00379821|Primary|Number of Clinical Malaria Episodes Per Year of Follow-up|Clinical malaria episode was defined as at least one symptom of malaria and a positive malaria smear. The number of clinical malaria episodes (not including the initial malaria episode) reported by participants during follow up is presented as the number per Person Years at Risk (PYAR).|1 year|The intention to treat (ITT) population was used for the primary outcome.||Episodes per PYAR|||Number
847936|NCT00375752|Secondary|Mean Changes From Baseline in FACT-B Total Score at 6 Months (ITT, Data as Observed)|"The FACT-B total score is calculated by summing all five unweighted subscale scores, with total scores in the range of 0–144.To Derive a FACT-B total score: all sections added together The higher the score the better the QoL
+ __________ + __________ + __________ + __________ =________=FACT-B Total score (PWB score) (SWB score) (EWB score) (FWB score) (BCS score)"|baseline and 6 mos|ITT||score on a scale||Standard Deviation|Mean
847937|NCT00375752|Secondary|Change From Baseline in Tumor Size (Longest Diameter) at Month 6|Tumor size (sum of longest diameter)was analyzed based on the diameters values provided with the central review.|Baseline, Month 6|The modified intent-to-treat (mITT) population included all patients of the ITT population for whom at least one post-baseline assessment of tumor response according to modified RECIST made by central review was available.||cm||Standard Deviation|Mean
847938|NCT00375752|Secondary|Number of Patients With Breast Conserving Surgery at 6 Months||Every 6 months|The intent-to-treat (ITT) population included all patients of the safety population for whom at least one post-baseline assessment of tumor response according to the modified RECIST (local or central assessment) was available. During different time points, participants with observations at that timepoint were included in the analysis.||Participants|||Number
847939|NCT00375752|Secondary|Best RECIST Response Based on Central Review at 6 Mos|Best response is defined as the best response the patients has reached during the 6 months of treatment. Response Evaluation Criteria in Solid Tumors (RECIST) has 4 response categories. CR (complete response) = disappearance of all target lesions, PR (partial response) = 30% decrease in the sum of the longest diameter of target lesions, PD (progressive disease) = 20% increase in the sum of the longest diameter of target lesions and SD (stable disease) = small changes that do not meet criteria.|6 Months|The modified intent-to-treat (mITT) population included all patients of the ITT population for whom at least one post-baseline assessment of tumor response according to modified RECIST made by central review was available.||Participants|||Number
847940|NCT00375752|Primary|Tumor Response Rate (Complete Response (CR) or Partial Response (PR)) Based on MRI- or Mammography and/or Sonography According to Modified RECIST Criteria at Month 6|Sum of longest diameter for all target lesions was reported as baseline sum LD. Baseline sum LD was used as reference to characterize objective tumor response. Response Evaluation Criteria in Solid Tumors has 4 response categories. CR (complete response) = disappearance of all target lesions, PR (partial response)= 30% decrease in sum of longest diameter of target lesions, PD (progressive disease) = 20% increase in the sum of the longest diameter of target lesions and SD(stable disease)=small changes that do not meet criteria. Analysis was underpowered due to insufficient recruitment rate.|6 months|The modified intent-to-treat (mITT) population included all patients of the ITT population for whom at least one post-baseline assessment of tumor response according to modified RECIST made by central review was available.||percentage of participants||95% Confidence Interval|Number
847941|NCT00375219|Secondary|Kaplan-Meier Estimates for Overall Survival|Overall survival is defined as the time from the initiation of treatment until death from any cause or the last day of participant contact or evaluation for participants that were lost to follow-up. Participants were censored t the last recorded contract or evaluation when a participant was alive at time of analysis. A quarterly phone survey was conducted to collect survival data for participants who discontinued from the study.|up to 4 years|Intent to treat||months||95% Confidence Interval|Median
847942|NCT00375219|Secondary|Kaplan-Meier Estimates for Time to Disease Progression|Time to disease progression is defined as the time from the initiation of treatment until the onset date of death, the development of CML accelerated phase or blast phase, or the loss of complete hematologic response or major cytogenetic response, whichever came first. Participants were censored only if they did not have progression or if they discontinued treatment for reasons other than AE, progression or death.|up to 4 years|Intent to treat||months||95% Confidence Interval|Median
847943|NCT00375219|Secondary|Kaplan-Meier Estimates for Duration of Best Cytogenetic Response|Duration of response is defined as the time from first reported date of cytogenetic response until the earliest date of objective evidence of disease progression, relapse or death. Data was censored at the last examination date for participants with ongoing response or participants who discontinued treatment for reasons other than adverse event, disease progression or death.|up to 4 years|Intent to treat population of participants who had a response||months||Full Range|Median
847944|NCT00375219|Secondary|Kaplan-Meier Estimates for Duration of Best Hematologic Response|Duration of response is defined as the time from first reported date of hematologic response until the earliest date of objective evidence of disease progression, relapse or death. Data was censored at the last examination date for participants with ongoing response or participants who discontinued treatment for reasons other than adverse event, disease progression or death.|up to 4 years|Intent to treat population of participants who had a response||months||Full Range|Median
847945|NCT00375219|Secondary|Kaplan-Meier Estimates for Time to Onset of Best Cytogenetic Response|"Time to onset was analyzed using Kaplan-Meier estimates. Participants who did not achieve a response are censored at their last visit day.
Major cytogenetic response includes complete or partial response. Both confirmed and unconfirmed major cytogenetic response is considered meaningful.
Unconfirmed response is based on a single bone marrow cytogenetic evaluation for participants where a confirmatory evaluation is not available.
Complete response shows 0% Philadelphia chromosome positive (Ph+) cells. A partial response shows >0% - 35% Ph+ cells."|up to 3 years|Intent to treat||months||95% Confidence Interval|Median
847946|NCT00375219|Secondary|Kaplan-Meier Estimates for Time to Onset of Best Hematologic Response|"Time to onset was analyzed using Kaplan-Meier estimates. Participants who did not achieve a response are censored at their last visit day.
Overall hematologic response for chronic phase participants includes confirmed complete hematologic response (CHR). Overall hematologic response for accelerated or blast phase participants includes confirmed complete hematologic response (CHR), no evidence of leukemia (NEL), or return to chronic phase (RCP). Hematologic response must last >= 8 weeks to be considered meaningful."|Day 1 up to Month 6|Intent to treat||months||95% Confidence Interval|Median
847947|NCT00375219|Secondary|Number of Treatment Cycles Needed to Achieve Best Cytogenetic Response||Day 1 up to 22 months|Intent to treat population of participants who had a cytogenetic response||treatment cycles||Full Range|Median
847948|NCT00375219|Secondary|Number of Treatment Cycles Needed to Achieve Best Hematologic Response|Induction therapy was administered for 14 consecutive days for each 28 days cycle, for up to 6 cycles. All treatment arms were given omacetaxine mepesuccinate via subcutaneous (SC) administration at 1.25 mg/m^2 twice a day (BID) for the 14 consecutive days.|Day 1 up to Month 6|Intent to treat population of participants who had a response to treatment||treatment cycles||Full Range|Median
847949|NCT00375219|Secondary|Percentage of Participants With the Largest Percentage Reduction From Baseline of T315I Mutated BCR-ABL|Summarization is based on the best of the individual response assessments. Not assessable indicates that the participant either had no baseline assessment or the % mutation could not be determined in the post-baseline assessment(s).|Day 1 up to Month 9|Intent to treat population of participants with post-baseline assessment of T315I mutated BCR ABL||percentage of participants||95% Confidence Interval|Number
847969|NCT00355121|Primary|Number of Participants With Antibodies Against Diphtheria and Tetanus at ≥ 1.0 IU/mL After DAPTACEL Vaccination|Serum antibody titers were assessed for diphtheria by a seroneutralization assay and for tetanus by enzyme linked immunosorbent assay.|Day 30 post-vaccination (Visit 1)|Serum antibody titers were assessed in the per-protocol population. (Participants in Group 3 did not receive DAPTACEL vaccine at Visit 1)||Participants|||Number
847950|NCT00375219|Secondary|Percentage of Participants With Extramedullary Disease (EMD) at Baseline Achieving a Clinical Response|"Clinical response was defined by disease phase and based on evaluations by the independent Data Monitoring Committee (DMC).
Chronic Phase subgroup: achieving a complete hematologic response and/or major cytogenetic response (complete cytogenetic response or partial cytogenetic response, confirmed or unconfirmed).
Accelerated Phase and Blast Phase subgroups: achieving complete hematologic response, no evidence of leukemia, return to chronic phase, and/or major cytogenetic response (complete cytogenetic response or partial cytogenetic response, confirmed or unconfirmed).
The percentage of participants achieving response with extramedullary disease at Baseline was to be summarized, if the sample size was sufficient. This analysis was not done as the sample was ultimately insufficient"|Day 1 up to Month 9|Intent to treat population of study participants who had extramedullary disease at baseline. Analysis not performed due to insufficient sample size.|||||
847951|NCT00375219|Secondary|Percentage of Participants in Each Hematologic Response Category|"Complete Response (CHR)
Chronic phase must last at least 8 weeks: WBC <10*10^9/liter, platelets <450*10^9/liter, myelocytes + metamyelocytes <5% in blood, no blasts or promyelocytes in blood, <20% basophils in peripheral blood, no extramedullary involvement.
Accelerated and Blast phase must last at least 4 weeks: absolute neutrophil count 1.5*10^9/liter, platelets 100*10^9/liter, no blood blasts, bone marrow blasts <5%, no extramedullary disease.
Partial Response - CHR plus one or more of the following:
Persistence of splenomegaly with a reduction of ≥50% from pre-treatment
Platelets > 450*10^9/L
Presence of immature cells in the peripheral blood
5% to 25% blasts in the bone marrow
If extra-medullary disease pre-treatment, reduction by ≥50% Hematologic Improvement - CHR, except allowing persistent thrombocytopenia (<100*10^9/L), and a few immature cells No evidence of leukemia: Morphologic leukemia-free state, defined as <5% bone marrow blasts."|Day 1 up to Month 6|Intent to treat||percentage of participants|||Number
847952|NCT00375219|Secondary|Percentage of Participants With Major Molecular Response (MMR) Representing the Degree of Suppression of BCR-ABL Transcript Levels Using the Housekeeping Gene ABL|MMR is defined as a ratio of BCR-ABL/standard gene of less than 0.1% according to the international scale. BCR-ABL is a fusion gene of the breakpoint cluster region [BCR] gene and Abelson proto-oncogene [ABL] genes). This analysis used the standard gene ABL. Analysis was performed by quantitative reverse transcription polymerase chain reaction (qRT-PCR) of peripheral blood.|Day 1 up to Month 6|Intent to treat population of participants who had evaluable samples. Participants with no data for these analyses either had degraded samples or the samples were missing.||percentage of participants||95% Confidence Interval|Number
847953|NCT00375219|Secondary|Percentage of Participants With Major Molecular Response (MMR) Representing the Degree of Suppression of BCR-ABL Transcript Levels Using the Housekeeping Gene GUS|MMR is defined as a ratio of BCR-ABL/standard gene of less than 0.1% according to the international scale. BCR-ABL is a fusion gene of the breakpoint cluster region [BCR] gene and Abelson proto-oncogene [ABL] genes). This analysis used the standard gene GUS. Analysis was performed by quantitative reverse transcription polymerase chain reaction (qRT-PCR) of peripheral blood.|Day 1 up to Month 6|Intent to treat population of participants who had evaluable samples. Participants with no data for these analyses either had degraded samples or the samples were missing.||percentage of participants||95% Confidence Interval|Number
847954|NCT00375219|Secondary|Percentage of Participants in Each Cytogenetic Response Category Representing the Degree of Suppression of the Philadelphia Chromosome (Ph+)|"Cytogenetic response categories:
Complete: 0% Ph+ cells
Partial: >0%-35% Ph+ cells
Minor: >35%-65% Ph+ cells
Minimal: >65%-95% Ph+ cells
No Response: >95% Ph+ cells
Unevaluable: <20 metaphases were examined and/or response could not be assigned"|Day 1 up to Month 9|Intent to treat||percentage of participants|||Number
847955|NCT00375219|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Subpopulation and Total|"TEAE are any untoward events that were newly occurring or worsening from Baseline.
Treatment related toxicity was considered by the investigator to be unrelated, possibly, probably or unknown related to study drug.
Severity was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 on the following scale: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening, Grade 5 = death.
A serious adverse event (SAE) is any untoward medical occurrence that is fatal or life-threatening; results in persistent or significant disability or incapacity; requires or prolongs in-patient hospitalization; is a congenital anomaly/birth defect in the offspring of a patient; and conditions not included in the above that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above.
A participant is only counted once in each category (at worst severity or strongest relationship)."|up to 3 years|Intent to treat||participants|||Number
847956|NCT00375219|Primary|Percentage of Participants Achieving a Major Cytogenetic Response by Subpopulation and Total Population|"Subpopulations reflect chronic myeloid leukemia (CML) phases at the time of enrollment: chronic, accelerated, and blast phase. Primary endpoints as adjudicated by the Data Monitoring Committee were used for the primary analyses.
Major cytogenetic response includes complete or partial response. Both confirmed and unconfirmed major cytogenetic response is considered meaningful.
Unconfirmed response is based on a single bone marrow cytogenetic evaluation for participants where a confirmatory evaluation is not available.
Complete response shows 0% Philadelphia chromosome positive (Ph+) cells. A partial response shows >0% - 35% Ph+ cells.
Response rates by disease phase were examined relative to an a priori value of 2.5% using a one-sided lower 95% exact binomial confidence limit. If the lower limit from the one-sided lower 95% confidence limit exceeds 2.5%, the observed response rate will have exceeded the minimum threshold required to demonstrate efficacy."|Day 1 up to 6 months|Intent to treat||percentage of participants||95% Confidence Interval|Number
847970|NCT00354172|Secondary|Chimerism After Double Umbilical Cord Blood Transplant (UCBT)|Calculation of Median (range) of percentage of donor cells engrafted (present) in the recipient (patient).|Day 21, Day 100, 6 Months|1 Year and 2 Year Post Transplant data was not applicable; no patients reached this timeframe to evaluate.||Percentage of Engrafted Cells||Full Range|Median
847971|NCT00354172|Secondary|Number of Participants (Patients) With Successful Natural Killer Cell Expansion|Defined by an absolute circulating donor-derived natural killer cell count of >100 cells/microliter 10-13 days after infusion with <5% donor T and B cells in the mononuclear population|10-13 Days Post Infusion|||Participants|||Number
847972|NCT00354172|Secondary|Number of Participants (Patients) Who Experienced Relapse by 24 Months|Number of patients who experienced recurrence or progression of disease from the time of transplant.|2 Years Post transplant|||Participants|||Number
847957|NCT00375219|Primary|Percentage of Participants Achieving an Overall Hematologic Response by Subpopulation and Total Population|"Subpopulations reflect chronic myeloid leukemia (CML) phases at the time of enrollment: chronic, accelerated, and blast phase. Primary endpoints as adjudicated by the Data Monitoring Committee were used for the primary analyses.
Overall hematologic response for chronic phase participants includes confirmed complete hematologic response (CHR). Overall hematologic response for accelerated or blast phase participants includes confirmed complete hematologic response (CHR), no evidence of leukemia (NEL), or return to chronic phase (RCP). Hematologic response must last >= 8 weeks to be considered meaningful.
Response rates by disease phase were examined relative to an a priori value of 2.5% using a one-sided lower 95% exact binomial confidence limit. If the lower limit from the one-sided lower 95% confidence limit exceeds 2.5%, the observed response rate will have exceeded the minimum threshold required to demonstrate efficacy."|Day 1 up to 6 months|Intent to treat population||percentage of participants||95% Confidence Interval|Number
847958|NCT00374907|Other Pre-specified|Marked Laboratory Abnormalities - During ST + LT Treatment Period|A laboratory value was considered a marked abnormality if it is outside the pre-defined criteria for marked abnormality and the on-treatment value was more extreme (farther from the limit) than the baseline value. Pre-Rx=pretreatment; ULN=upper limit of normal; ALP=alkaline phosphatase; AST=aspartate aminotransferase; ALT=alanine aminotransferase; BUN=blood urea nitrogen; unspec.=unspecified; sodium serum low: <0.9 x Pre-Rx & <=130mEq/L / high: >1.1 x Pre-Rx & >=150mEq/L; potassium, serum low: <=0.8 x Pre-Rx & >=6.0mEq/L / high: 1.2 x Pre-Rx & >=6.0mEq/L; LLN=lower limit of normal.|116 weeks|Number of Participants Analyzed=Treated participants; n=number of treated subjects with baseline value and at least one value during the ST + LT treatment period.||participants|||Number
847959|NCT00374907|Other Pre-specified|Overall Summary of Adverse Events (AEs) Serious AEs (SAEs), Discontinuations, and Deaths During the ST + LT Treatment Period|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Related events=relationship of certain, probable, possible, or missing.|116 weeks|Treated participants||participants|||Number
847960|NCT00374907|Secondary|Insulin Secretion Rate AUC During IV Hyperglycemic Clamp - Percent Change From Baseline at Week 12|Adjusted percent change in the insulin secretion rate AUC during an intravenous hyperglycemic clamp (120-180 minutes) at Week 12. The method used for calculating the insulin secretion rate was C-peptide deconvolution.|Baseline, Week 12|Randomized Participants with both a baseline and post-baseline value (up to Week 12).||Percent Change (Percentage of Baseline)||95% Confidence Interval|Geometric Mean
847961|NCT00374907|Primary|Insulin Secretion Rate Area Under the Curve (AUC) During Intravenous (IV)-Oral Hyperglycemic Clamp - Percent Change From Baseline at Week 12|Adjusted percent change in the insulin secretion rate AUC during a hyperglycemic clamp with an enteral glucose load [intravenous-oral hyperglycemic clamp (180-480 minutes)] at Week 12. The method used for calculating the insulin secretion rate was C-peptide deconvolution.|Baseline, Week 12|Randomized participants with both a baseline and post-baseline value (up to Week 12).||Percent Change (Percentage of Baseline)||95% Confidence Interval|Geometric Mean
847962|NCT00355121|Other Pre-specified|Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2|Solicited Injection Site Reactions: Pain, Erythema, and Redness. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, and Myalgia.|Day 0 through Day 7 post-vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.||Participants|||Number
847963|NCT00355121|Other Pre-specified|Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1|Solicited Injection Site Reactions: Pain, Erythema, and Redness. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, and Myalgia.|Day 0 through Day 7 post-vaccination|Safety analysis was on all enrolled and vaccinated subjects with available reaction data, intent-to-treat population.||Participants|||Number
847964|NCT00355121|Other Pre-specified|Geometric Mean Titers Against Poliovirus After IPOL Vaccination.|Serum antibodies were assessed for poliovirus types 1, 2, and 3 by serum neutralization assay.|Day 30 post-vaccination|Serum antibody titers were assessed in the per-protocol population. (Participants received IPOL at Visit 1 in Group 1 and 3, and at Visit 2 for Group 2||Titers||95% Confidence Interval|Geometric Mean
847965|NCT00355121|Secondary|Number of Participants Reporting Fever When DAPTACEL and Menactra Vaccines Were Administered Concomitantly and Those Reporting When DAPTACEL Was Administered With IPOL Vaccine|Fever was defined as a maximum oral temperature of ≥ 100.4ºF.|Day 0 through Day 7 post-vaccination at Visit 1|Safety analysis was on enrolled and vaccinated participants with available reaction data, intent-to-treat population.||Participants|||Number
847966|NCT00355121|Secondary|Serum Bactericidal Assay Using Human Complement Geometric Mean Titers for Serogroups A, C, Y, and W-135 After Menactra Vaccination|Serum antibody titers against meningococcal serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA HC)|Day 30 post-vaccination|Serum antibody titers were assessed in the per protocol population. Participants in Group 1 received Menactra vaccine at Visit 2, Group 3 at Visit 1.||Titers||95% Confidence Interval|Geometric Mean
847967|NCT00355121|Secondary|Geometric Mean Concentrations (GMCs) of Antibodies Against the Pertussis Antigens After DAPTACEL Vaccination at Visit 1|Serum antibody titers against pertussis were assessed for pertussis toxoid (PT), filamentous hemagglutinin (FHA), Fimbriae types 2 and 3 (FIM), and pertactin (RN) by enzyme linked immunosorbent assay (ELISA).|Day 30 post-vaccination 1|Serum antibody titers were assessed in the per-protocol population. (Participants in Group 3 did not receive DAPTACEL vaccine at Visit 1)||EU/mL||95% Confidence Interval|Geometric Mean
847968|NCT00355121|Primary|Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W-135 After Menactra Vaccination at Visit 1.|Serum antibody titers against meningococcal serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA HC)|Day 30 post-vaccination (Visit 1)|Serum antibody titers were assessed in the per-protocol population. (Participants in Group 1 did not receive Menactra vaccine at Visit 1)||Titers||95% Confidence Interval|Geometric Mean
847977|NCT00354172|Secondary|Number of Participants (Patients) With Acute Graft-versus-Host Disease at Grade III-IV|Graft-versus-host disease (GVHD) is a common complication of transplantation in which functional immune cells in the transplanted marrow recognize the recipient as foreign and mount an immunologic attack. The acute or fulminant form of the disease (aGVHD) is normally observed within the first 100 days post-transplant, and is a major challenge to transplants owing to associated morbidity and mortality. Acute GVHD is staged as follows: overall grade (skin-liver-gut) with each organ staged individually from a low of I to a high of IV. Patients with grade IV GVHD usually have a poor prognosis.|Day 100 post transplant|||Participants|||Number
847978|NCT00354172|Secondary|Number of Participants (Patients) With Acute Graft-versus-host Disease (GVHD) Grade II-IV|Graft-versus-host disease (GVHD) is a common complication of transplantation in which functional immune cells in the transplanted marrow recognize the recipient as foreign and mount an immunologic attack. The acute or fulminant form of the disease (aGVHD) is normally observed within the first 100 days post-transplant, and is a major challenge to transplants owing to associated morbidity and mortality. Acute GVHD is staged as follows: overall grade (skin-liver-gut) with each organ staged individually from a low of I to a high of IV. Patients with grade IV GVHD usually have a poor prognosis.|Day 100 Post Transplant|||Participants|||Number
847979|NCT00354172|Secondary|Number of Participants (Patients) Who Attained Platelet Engraftment|Platelet engraftment is defined as platelet counts > 50 x 10^9/Liter for 3 consecutive days.|1 Year Post Transplant|||Participants|||Number
847980|NCT00354172|Secondary|Number of Participants (Patients) Who Attained Neutrophil Engraftment|"Defined as absolute neutrophils (ANC) > 5 x 10^8/Liter for 3 consecutive days.
ANC is the real number of white blood cells (WBCs) that are neutrophils. The absolute neutrophil count is commonly called the ANC. The ANC is not measured directly. It is derived by multiplying the WBC count times the percent of neutrophils in the differential WBC count. The percent of neutrophils consists of the segmented (fully mature) neutrophils) + the bands (almost mature neutrophils). The normal range for the ANC = 1.5 to 8.0 (1,500 to 8,000/mm3)."|Day 42 Post Transplant|||Participants|||Number
847981|NCT00354172|Secondary|Number of Participants (Patients) Who Died Due to Transplant.|Patients who had transplant-related mortality (TRM). TRM = adverse event(s) that occur(s) after the patient has received a transplant, the principal investigator decides it is related to the procedure and the patient dies within 6 months.|6 Months Post Transplant|||Participants|||Number
847982|NCT00354172|Secondary|Number of Patients Who Were Disease-free and Alive at 24 Months|Number of patients who were alive and free of disease (malignancy) at 24 months after transplant.|24 Months Post transplant|||Participants|||Number
847983|NCT00354172|Secondary|Number of Participants (Patients) Who Were Disease-free and Alive at 12 Months|Number of patients who were alive and free of disease (malignancy) at 12 months after transplant.|12 Months Post transplant|||Participants|||Number
847984|NCT00354172|Primary|Number of Participants (Patients) Who Were Disease-free and Alive at 6 Months|Number of patients who were alive and free of disease (malignancy) at 6 months after transplant.|6 Months Post Transplant|One patient did not receive umbilical cord transplant and was not included in this Evaluable patient group.||Participants|||Number
847993|NCT00324896|Secondary|WASO|Wake after sleep onset in minutes|6 weeks|intent to treat||minutes||Standard Deviation|Mean
847994|NCT00324896|Primary|TST|Total sleep time in hours|6 weeks|intent to treat approach||hours||Standard Deviation|Mean
848037|NCT00289536|Secondary|Terminal Half-life|Computed from the regression slope in the terminal phase of the model (the slope is biphasic). Terminal half life is the time it takes for the plasma concentration or the amount of drug in the body to be reduced by 50%.|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Per protocol population: participants who were randomized, received all 3 doses of rAHF-PFM, and had pharmacokinetic assessments.||hour||Full Range|Median
847995|NCT00324155|Secondary|Time to Resolution of Grade 2-3, Grade 3-4 Immune-related Adverse Events (irAEs)|irAEs included the categories: gastrointestinal (GI), diarrhea, liver, endocrine, and skin. Grade 2=Moderate adverse events (AEs); minimal, local or noninvasive intervention indicated. Grade 3=severe AEs, medically significant but not immediately life-threatening. Grade 4=life-threatening consequences; urgent intervention indicated. Time to resolution is defined as improvement to Grade 1 or less or to the Grade at baseline (prior to treatment).|Week 1 (first dose) to 70 days after last dose up to database lock for primary endpoint (approximately 5 years)|All participants who received at least 1 dose of study drug and had a specific event that resolved||Weeks||95% Confidence Interval|Median
847996|NCT00324155|Secondary|Number of Participants With Grade 2-3 and Grade 3-4 Immune-related Adverse Events (irAEs) With Resolution Resolved|irAEs included the categories: gastrointestinal (GI), diarrhea, liver, endocrine, and skin. Grade 2=moderate adverse events (AEs); minimal, local, or noninvasive intervention indicated. Grade 3=severe AEs, medically significant but not immediately life-threatening. Grade 4=life-threatening consequences; urgent intervention indicated. Resolution is defined as improvement to Grade 1 or less or to the Grade at baseline (prior to treatment).|Week 1 (first dose) to 70 days after last dose up to data cutoff for primary endpoint (approximately 5 years)|All participants who received at least 1 dose of study drug and had this specific event||Participants|||Number
847997|NCT00324155|Secondary|Number of Participants With Adverse Events (AEs), Drug-related AEs, AEs Leading to Discontinuation, Serious Adverse Events (SAEs), Drug-related SAEs, Drug-related Hypersensitivity, Immune-related AEs/SAEs, and Inflammatory AEs/SAEs|AE=any new undesirable symptom, sign, clinically significant laboratory abnormality, or medical condition occurring after starting study treatment, even if the event was not considered to be drug-related. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. Randomization=Day 1; start of treatment (first dose)=Week 1. Summarization time frame is from first dose to 70 days after last dose of study at time of 414 deaths.|Week 1 (First Dose) to 70 days after last dose of study up to data cutoff for primary endpoint (approximately 5 years)|All participants who received at least 1 dose of randomized ipilimumab or placebo and/or dacarbazine||Participants|||Number
847998|NCT00324155|Primary|Overall Survival (OS)|OS was defined as the time from the date of randomization until the date of death. Analysis of OS was to be done once 416 deaths had occurred (primary endpoint). However, analysis occurred at 414 deaths (February 7, 2011), due to operational timing of the study. Median number of months of OS and associated confidence interval calculated using the method of Brookmeyer and Crowley.|Date of randomization to 37 months through 5-year follow-up and up to approximately 76 months|All randomized participants whose survival follow-up was current (defined as having died or last known alive date occurring on or after the data cutoff date, which was when a total of 414 deaths occurred).||Months||95% Confidence Interval|Median
847999|NCT00324155|Secondary|Percentage of Participants With Brain Metastasis-Free Survival at Time of Data Cutoff|Brain metastasis-free survival was defined as the time from randomization to the date of progression with a new lesion located in the brain. New brain lesions prior to Week 12 constituted a progression event (unlike main progression-free survival analysis). A participant who dies without documentation of a brain lesion was considered to have progressed with brain metastasis on the date of death. Participants who are free of brain metastasis were censored on the date of their last tumor assessment. An independent review committee evaluated images of participants with clinical symptoms to determine the number of those free of brain metastasis. The brain metastasis-free status was reported as a percent of participants (n/N), where n= participants with metastasis-free brains at data cutoff for the Primary Endpoint and N= randomized participants. A 2-sided Clopper and Pearson confidence interval was performed.|Date of randomization up to data cutoff for primary endpoint (approximately 5 years)|All participants who were randomized to a treatment group||Percentage of participants||95% Confidence Interval|Number
848000|NCT00324155|Secondary|Duration of Stable Disease (SD): Randomized Participants With Stable Disease|Duration of SD was defined in those whose Best Overall Response (BOR) was SD, per independent review committee (IRC) as the time between Week 12 and date of progressive disease (PD) or death , whichever occurs first. For those who underwent tumor resection following Week 12 but prior to PD, duration of SD was censored on date of last evaluable tumor assessment (TA) prior to resection. For those with BOR of SD at Week 12, date of PD was used in analysis of duration of SD. For those with BOR=SD who have not subsequently progressed and who remain alive, duration of SD censored on date of last evaluable TA. Modified criteria of the World Health Organization (mWHO): SD=insufficient decrease to qualify for partial response or sufficient increase to qualify for PD; PD=an increase of 25% or more in sum of products of longest diameter and greatest perpendicular diameter of index lesions compared with smallest recorded sum, or appearance of 1 or more new lesions.|Week 12 to date of disease progression or death up to data cutoff for primary endpoint (approximately 5 years)|All participants who were randomized to a treatment group and had SD||Months||95% Confidence Interval|Median
848001|NCT00324155|Secondary|Time to Response: All Randomized Participants With Response to Treatment|Time to response was defined as the time between the first dose of study therapy and the date when measurement criteria were met for Best Overall Response (BOR) of partial response (PR) or complete response (CR), whichever occurred first, per independent review committee. Note that if an overall response of PR occurred before confirmation of CR, the time to response endpoint was not determined by the time that the BOR of CR was shown but rather by the earlier time point showing PR. Modified criteria of the World Health Organization: CR=disappearance of all lesions; no evidence of progressive disease (PD); PR=50% or more decrease in the sum of products of the longest and greatest perpendicular diameters (SPD) of all index lesions compared with baseline; PD=an increase of 25% or greater in the SPD of index lesions compared with the smallest recorded sum, or the appearance of 1 or more new lesions.|First dose to date of BOR up to data cutoff for primary endpoint (approximately 5 years)|All participants who were randomized to a treatment group and who had a response of CR or PR||Months||Full Range|Median
848283|NCT00121641|Other Pre-specified|Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point||x 10^3 c/µL||Standard Error|Mean
848002|NCT00324155|Secondary|Duration of Response (DOR): Randomized Participants With Response of Complete Response (CR) or Partial Response (PR)|DOR defined in those with Best Overall Response (BOR)=CR or PR per independent review committee (IRC) as time between date of response of confirmed CR or PR, whichever occurred first, and date of PD or death. If PR assessed before CR, DOR confirmed at earlier time-point showing PR. Modified criteria of the World Health Organization (mWHO): CR=disappearance of all lesions;no evidence of PD; PR=50% or greater decrease in the sum of products of longest and greatest perpendicular diameters (SPD) of all index lesions compared with baseline. PD=an increase of 25% or greater in SPD of index lesions compared with the smallest recorded sum, or appearance of 1 or more new lesions. Immune-related response criteria (irRC): SD=50% decrease in total measurable tumor burden compared with peak cannot be established nor 25% increase compared with nadir, in absence of unequivocal progression of nonindex lesions. Unconfirmed immune-related (ir) CR, irPR, or irPD=irSD.|Day of CR or PR to day of PD or death up to data cutoff for primary endpoint (approximately 5 years)|All participants who were randomized to a treatment group and had a response of CR, PR, irCR, or irPR. n=number of participants who responded by mWHO criteria and irRC.||Months||95% Confidence Interval|Median
848003|NCT00324155|Secondary|Best Overall Response Rate (BORR)|BORR=number with Best Overall Response (BOR) of complete response (CR) or partial response (PR), divided by total number of randomized patients. BOR=date of first dose to the last tumor assessment prior to subsequent cancer therapy (including tumor resection surgery but excluding palliative local radiotherapy for bone lesions). Independent review committee assessment. Modified criteria of the World Health Organization (mWHO): CR=disappearance of all lesions; no evidence of progressive disease; PR=50% or greater decrease in the sum of products of the longest diameter and greatest perpendicular diameter of all index lesions compared with baseline. Immune-related (ir) response criteria (irRC) assess tumor response in patients on immunotherapy: irCR=disappearance of all lesions in 2 consecutive observations at least 4 weeks apart; irPR=50% or greater decrease in total measureable tumor burden compared with peak in 2 observations at least 4 weeks apart.|First dose to last tumor assessment at data cutoff for primary endpoint (approximately 5 years)|All participants who were randomized to a treatment group||Percentage of participants||95% Confidence Interval|Number
848004|NCT00324155|Secondary|Progression-free Survival (PFS) Rate Truncated at Week 12|PFS rate=probability patient was progression-free at Day 78, calculated as total patients receiving treatment and with an overall response of stable disease (SD), partial response (PR), or complete response (CR) at Week 12, divided by total patients. For those alive and not progressed at or before Week 12, PFS censored on date of last evaluable tumor assessment (TA) at or before Week 12. Those with an assessment of PD prior to Week 12 and subsequent assessment of SD, PR, or CR at Week 12 were called progression-free at Week 12. Those with no recorded postbaseline TA dated on or before Day 109, and who had not died on or before Day 109, were censored at randomization. PD=at least 25% increase in sum of products of all index lesions or appearance of any new lesions. Both an investigator and independent review committee (IRC) assessed radiologic imaging studies, photographs of skin lesions, and clinical data. IRC assessment was considered primary over that of the investigators.|Day 78|All participants who were randomized to a treatment group||Percentage of participants||95% Confidence Interval|Number
848005|NCT00324155|Secondary|Median Number of Months of Progression-free Survival (PFS)|PFS=time between randomization and date of progression or death, whichever occurs first. Participants who died without reported prior progression were considered to have progressed on date of death. For those alive and not progressed, PFS was censored on date of last evaluable tumor assessment (TA). Those who have not died and have no recorded postbaseline TA were censored at randomization. Those who died without any recorded postbaseline TA were considered to have progressed on date of death. Evaluation was conducted by both investigator and an independent review committee (IRC), who assessed radiologic imaging studies, photographs of skin lesions, and clinical data. Progressive disease defined using modified criteria of the World Health Organization: demonstration of at least a 25% increase in the sum of products of all index lesions or the appearance of any new lesions. For nonindex lesions: appearance of any new lesions or unequivocal progression of nonindex lesions.|Randomization to date of progression or death to approximately 5 years|All participants who were randomized to a treatment group||Months||95% Confidence Interval|Median
848006|NCT00324155|Secondary|Disease Control Rate (DCR)|DCR=number whose best overall response (BOR) was partial response (PR), complete response (CR) or stable disease (SD), divided by all randomized participants (unevaluable participants included). Independent review committee assessment. BOR=date of first dose to last tumor assessment prior to subsequent cancer therapy (including tumor resection, excluding palliative local radiotherapy). Modified World Health Organization criteria: CR=disappearance of all lesions; no evidence of progressive disease (PD); PR=50% or more decrease in the sum of products of the longest diameter and greatest perpendicular diameter of all index lesions compared with baseline; SD=neither sufficient decrease to qualify for PR nor sufficient increase to qualify for PD; PD=at least 25% increase in sum of products of all index lesions and/or appearance of any new lesions; nonindex lesions: appearance of any new lesions and/or unequivocal progression of nonindex lesions.|First dose to last tumor assessment prior to subsequent therapy at data cutoff for Primary Endpoint (approximately 5 years)|All participants who were randomized to a treatment group||Percentage of participants|||Number
848007|NCT00324155|Secondary|Survival Rate at 1 Year, 18 Months, 2 Years, and 3 Years|The survival rate (percentage of participants alive) was defined as the probability that a participant is alive at 1 year (or 18 months, 2 years, or 3 years) following randomization and was estimated via the Kaplan-Meier method.|Date of randomization to 3 years following randomization|All participants who were randomized to a treatment group||Percentage of participants||95% Confidence Interval|Number
848008|NCT00322465|Secondary|Specimens for Future Studies to Determine the Role of Unique and Novel Pathogens in the Etiology of Non-gonococcal Urethritis|Urethral swabs and urine specimens collected at each study visit for future studies to determine the role of unique and novel pathogens in the etiology of non-gonococcal urethritis|Baseline (enrollment); First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)||||||
848038|NCT00289536|Secondary|Area Under the Curve/Dose|Area under the plasma factor VIII concentration versus time curve (AUC) estimated by linear trapezoidal method per dose.|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Per protocol population: participants who were randomized, received all 3 doses of rAHF-PFM, and had pharmacokinetic assessments.||IU*hour/dL per IU/kg||Full Range|Median
848009|NCT00322465|Primary|Percentage of Participants Achieving Clinical Cure of Non-gonococcal Urethritis (NGU) With Doxycycline Versus Doxycycline With Tinidazole; and Azithromycin Versus Azithromycin With Tinidazole|"Clinical Cure of NGU: Did not meet criteria for clinical failure at last evaluable follow-up visit.
Clinical Failure at first follow-up: [Persistent symptoms AND >= 5 polymorphonuclear leukocytes (PMNs) per 3-5 oil immersion fields (regardless of urethral discharge)] OR Persistent urethral discharge on exam (regardless of symptoms or number of PMNs).
Clinical Failure at second follow-up: >= 5 PMNs per 3-5 oil immersion fields (regardless of symptoms or presence of urethral discharge) OR Persistent urethral discharge on exam (regardless of symptoms or number of PMNs)"|First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)|Modified intent to treat: all subjects randomized who received at least one dose of study drug therapy or placebo||Percentage of participants|||Number
848010|NCT00322465|Primary|Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting Diarrhea|At all study visits, unsolicited adverse events were recorded. Nausea, Vomiting, Abdominal pain, and Diarrhea were recorded using National Cancer Institute Common Toxicity Criteria (Version 3.0).|First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)|Modified intent-to-treat population was comprised of all subjects randomized who received at least one dose of study drug therapy or placebo||Participants|||Number
848011|NCT00322465|Primary|Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting of Abdominal Pain|At all study visits, unsolicited adverse events were recorded. Nausea, Vomiting, Abdominal pain, and Diarrhea were recorded using National Cancer Institute Common Toxicity Criteria (Version 3.0).|First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)|Modified intent-to-treat population was comprised of all subjects randomized who received at least one dose of study drug therapy or placebo||Participants|||Number
848012|NCT00322465|Primary|Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting Stomach Upset|At all study visits, unsolicited adverse events were recorded.|First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)|Modified intent-to-treat population was comprised of all subjects randomized who received at least one dose of study drug therapy or placebo||Participants|||Number
848013|NCT00322465|Secondary|Clinical, Behavioral, and Demographic Predictors of Mycoplasma Genitalium in Men With Non-gonococcal Urethritis|Logistic multiple regression with independent variable selection based on single variable models with p<0.10. Participants positive at enrollment for Mycoplasma genitalium from urine specimen. Potential variables: discharge amount and appearance; condom use last sex; new recent partner, number of partners and new partners in last 30 days and last 3 months; number of times vaginal sex, oral sex, or anal sex in last 30 days; always/almost always used condom last 3 months.|Baseline (enrollment visit)|All study participants who met major eligibility criteria (per protocol) with evaluable baseline results.||Participants|||Number
848014|NCT00322465|Secondary|Clinical, Behavioral, and Demographic Predictors of Trichomonas Vaginalis in Men With Non-gonococcal Urethritis|Trichomonas vaginalis was determined from urethral swab or urine specimen. Clinical, behavioral, and demographic predictors considered included discharge amount and appearance; condom use last sex; new recent partner; number of partners and new partners in last 30 days and last 3 months; number of times vaginal sex, oral sex, or anal sex in last 30 days; always/almost always used condom in last 3 months.|Baseline (enrollment visit)|All study participants who met major eligibility criteria (per protocol) with evaluable baseline results.||Participants|||Number
848015|NCT00322465|Secondary|Clinical, Behavioral, and Demographic Predictors of Chlamydia Trachomatis in Men With Non-gonococcal Urethritis|Clinical, behavioral, and demographic variables considered were discharge amount and appearance; condom use last sex; new recent partner; number of partners and new partners in last 30 days as well as last 3 months; number of times vaginal sex, oral sex, or anal sex in past 30 days; always/almost always used condom in last 3 months.|Baseline (enrollment visit)|All study participants who met major eligibility criteria (per protocol) with evaluable baseline measures.||Participants|||Number
848016|NCT00322465|Secondary|Prevalence of Mycoplasma Genitalium in Men With Non-gonococcal Urethritis|Percentage of men with non-gonococcal urethritis that had a positive result for Mycoplasma genitalium at baseline (enrollment)|Baseline (enrollment)|All study participants with evaluable baseline test results.||Percentage of participants|||Number
848017|NCT00322465|Secondary|Prevalence of Trichomonas Vaginalis (Swab or Urine Specimen) in Men With Non-gonococcal Urethritis|Percentage of men with non-gonococcal urethritis that had a positive result for Trichomonas vaginalis from a urethral swab or urine specimen at baseline (enrollment)|Baseline (enrollment visit)|All study participants with evaluable baseline test results.||Percentage of participants|||Number
848018|NCT00322465|Secondary|Prevalence of Chlamydia Trachomatis in Men With Non-gonococcal Urethritis|Percentage of men with non-gonococcal urethritis that had a positive result for Chlamydia trachomatis at baseline (enrollment)|Baseline (enrollment visit)|All study participants with evaluable baseline test results.||Percentage of participants|||Number
848019|NCT00322465|Secondary|Percentage of Participants Achieving Microbiological Cure of Mycoplasma Genitalium With Doxycycline Versus Doxycycline With Tinidazole; and Azithromycin Versus Azithromycin With Tinidazole|Microbiological Cure of Mycoplasma Genitalium refers to the percentage of men with NGU who were negative for Mycoplasma Genitalium at the last available result and had been positive for Mycoplasma Genitalium at baseline.|First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)|Participants who were positive at baseline, returned for follow-up, and had evaluable test results.||Percentage of participants|||Number
848020|NCT00322465|Secondary|Percentage of Participants Achieving Microbiological Cure of Trichomonas Vaginalis With Doxycycline Versus Doxycycline With Tinidazole; and Azithromycin Versus Azithromycin With Tinidazole|Microbiological cure of Trichomonas vaginalis refers to the percentage of men with NGU who were negative for Trichomonas vaginalis (swab and urine specimens) at the last available result and had been positive for Trichomonas vaginalis at baseline (swab or urine specimen).|First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)|Participants who were positive at baseline, returned for follow-up, and had evaluable test results.||Percentage of participants|||Number
848039|NCT00289536|Primary|Initial Recovery|Percent increase in factor VIII concentration per dose from pre- to post-infusion|Pharmacokinetic evaluations: 30 minutes pre-infusion to 30 minutes post-infusion|Per protocol population: participants who were randomized, received all 3 doses of rAHF-PFM, and had pharmacokinetic assessments.||IU/dL per IU/kg||Full Range|Median
848021|NCT00322465|Secondary|Percentage of Participants Achieving Microbiological Cure of Chlamydia Trachomatis With Doxycycline Versus Doxycycline With Tinidazole; and Azithromycin Versus Azithromycin With Tinidazole|Microbiological cure of Chlamydia trachomatis refers to the percentage of men with NGU who were negative for Chlamydia trachomatis at the last available result and had been positive for Chlamydia trachomatis at baseline.|First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)|Participants who were positive at baseline, returned for follow-up, and had evaluable test results.||Percentage of participants|||Number
848022|NCT00322465|Secondary|Percentage of Participants Achieving Clinical Cure of NGU With (Doxycycline Plus Doxycycline/Tinidazole) Versus (Azithromycin Plus Azithromycin/Tinidazole)|"Clinical Cure of NGU: Did not meet criteria for clinical failure at last evaluable follow-up visit.
Clinical Failure at first follow-up: [Persistent symptoms AND >= 5 PMNs per 3-5 oil immersion fields (regardless of urethral discharge)] OR Persistent urethral discharge on exam (regardless of symptoms or number of PMNs).
Clinical Failure at second follow-up: >= 5 PMNs per 3-5 oil immersion fields (regardless of symptoms or presence of urethral discharge) OR Persistent urethral discharge on exam (regardless of symptoms or number of PMNs)"|First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)|Modified intent-to-treat population was comprised of all subjects randomized who received at least one dose of study drug therapy or placebo||Percentage of participants|||Number
848023|NCT00322465|Primary|Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting Vomiting|At all study visits, unsolicited adverse events were recorded. Nausea, Vomiting, Abdominal pain, and Diarrhea were recorded using National Cancer Institute Common Toxicity Criteria (Version 3.0).|First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)|Modified intent-to-treat population was comprised of all subjects randomized who received at least one dose of study drug therapy or placebo||Participants|||Number
848024|NCT00322465|Primary|Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting Nausea|At all study visits, unsolicited adverse events were recorded. Nausea, Vomiting, Abdominal pain, and Diarrhea were recorded using National Cancer Institute Common Toxicity Criteria (Version 3.0).|First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)|Modified intent-to-treat population was comprised of all subjects randomized who received at least one dose of study drug therapy or placebo||Participants|||Number
848025|NCT00306163|Secondary|Safety and Tolerability||5 weeks||||||
848026|NCT00306163|Secondary|Δ (FVC/SVC) at PC20 (AMP)|Change between baseline and post-treatment of the ratio of Forced Vital Capacity (FVC) and Slow Vital Capacity at PC20. Measured with either small or large partical size AMP.|Baseline and 5 weeks||||||
848027|NCT00306163|Primary|PC20 AMP (Post-treatment Compared to Baseline)|Mean change of Provocative concentration of Adenosine-5'-monophosphate (PC20 AMP) leading to a 20 percent decrease in Forced expiratory volume in one second (FEV1) between post-treatment and baseline using two different particle sizes. - Small particles = Mass mean aerodynamic diameter (MMAD) of approximately 1.04-1.08 micron - Large particles = MMAD of approximately 9.9-10.6 micron|Baseline and 5 weeks|The analyses on treatment effects were performed on all subjects who reached a PC20<640mg/mL.||Logarithm (mg/mL)||Standard Deviation|Mean
848028|NCT00289536|Secondary|Pre-infusion Von Willebrand Factor Antigen (VWF:Ag)|Percentage of VWF:Ag. Relationships between baseline VWF:Ag and pharmacokinetic parameters (initial recovery, total AUC/dose, and half-life) were evaluated statistically.|At baseline and before each pharmacokinetic evaluation|Intent to treat: participants who received at least 1 of the 3 infusions of rAHF-PFM and had pharmacokinetic evaluation(s).||U/dL||Full Range|Median
848029|NCT00289536|Secondary|Pre-infusion Von Willebrand Factor Ristocetin Cofactor Activity (VWF:Rco)|Percentage of normal VWF:Rco activity. Normal is a lab standard consisting of a non-hemophilic population. Relationships between baseline VWF:Rco and pharmacokinetic parameters (initial recovery, total AUC/dose, and half-life) were evaluated statistically.|At baseline and before each pharmacokinetic evaluation|Intent to treat: participants who received at least 1 of the 3 infusions of rAHF-PFM and had pharmacokinetic evaluation(s)||Percent of normal VWF:Rco activity||Full Range|Median
848030|NCT00289536|Secondary|Maximum Plasma Concentration|Maximal factor VIII concentration after infusion|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Per protocol population: participants who were randomized, received all 3 doses of rAHF-PFM, and had pharmacokinetic assessments.||IU/dL||Full Range|Median
848031|NCT00289536|Secondary|Volume of Distribution at Steady State|Computed as weight-adjusted CL * Mean Residence Time|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Per protocol population: participants who were randomized, received all 3 doses of rAHF-PFM, and had pharmacokinetic assessments.||dL/kg||Full Range|Median
848032|NCT00289536|Secondary|Mean Residence Time|Computed as total AUMC divided by total AUC|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Per protocol population: participants who were randomized, received all 3 doses of rAHF-PFM, and had pharmacokinetic assessments.||hour||Full Range|Median
848033|NCT00289536|Secondary|Weight-adjusted Clearance|Computed as weight-adjusted dose divided by total AUC|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Per protocol population: participants who were randomized, received all 3 doses of rAHF-PFM, and had pharmacokinetic assessments.||mL/kg*hour||Full Range|Median
848034|NCT00289536|Secondary|Total Area Under the Moment Curve|Total area under the first moment curve (AUMC) estimated by linear trapezoidal methods|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Per protocol population: participants who were randomized, received all 3 doses of rAHF-PFM, and had pharmacokinetic assessments.||IU*hour^2/dL||Full Range|Median
848035|NCT00289536|Secondary|Total Area Under the Curve|Total AUC with extrapolation using the slope of the β-phase|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Per protocol population: participants who were randomized, received all 3 doses of rAHF-PFM, and had pharmacokinetic assessments.||IU*hour/dL||Full Range|Median
848036|NCT00289536|Secondary|Area Under the Curve|AUC estimated by linear trapezoidal method. The linear trapezoidal method is a numerical method used to approximate the area under a curve.|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Per protocol population: participants who were randomized, received all 3 doses of rAHF-PFM, and had pharmacokinetic assessments.||IU*hour/dL||Full Range|Median
848043|NCT00256750|Secondary|Percent of Participants With Composite Endpoint or Death, Graft Loss or Acute Rejection by Month 36|Graft loss was defined as either functional loss or physical loss (nephrectomy). Functional loss was defined as a sustained level of serum creatinine (SCr) ≥ 6.0 milligrams per deciliter (mg/dL) or 530 micromoles per liter (μmol/L) as determined by the central laboratory for ≥ 4 weeks or ≥ 56 consecutive days of dialysis or impairment of renal function to such a degree that the participant underwent retransplant. Acute rejection was defined as central biopsy proven rejection that was either (1) clinically suspected by protocol defined reasons or (2) clinically suspected by other reasons and treated. Death and graft loss were not imputed.|Randomization to Month 36|All randomized and transplanted participants, intent to treat (ITT) population||percentage of participants||95% Confidence Interval|Number
848044|NCT00256750|Secondary|Percent of Participants Surviving With a Functioning Graft|Graft loss was defined as either functional loss or physical loss (nephrectomy). Functional loss was defined as a sustained level of serum creatinine (SCr) ≥ 6.0 milligrams per deciliter (mg/dL) or 530 micromoles per liter (μmol/L) as determined by the central laboratory for ≥ 4 weeks or ≥ 56 consecutive days of dialysis or impairment of renal function to such a degree that the participant underwent retransplant.|Months 24, 36|All randomized and transplanted participants, intent to treat (ITT) population. For 95% CI within each group, normal approximation is used in N>=5. Otherwise exact method is used.||percentage of participants||95% Confidence Interval|Number
848045|NCT00256750|Secondary|Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36|SF-36 was a Participant-Reported Quality of Life (QoL) Short Form (SF) questionnaire measuring health-related quality of life (HRQL) covering 2 scale measures: physical component summary (PCS) and mental component summary (MCS). PCS represented by 4 domains: physical function, role limitations due to physical problems, pain, and general health perception. MCS represented by 4 domains: vitality, social function, role limitations due to emotional problems, and mental health. Their scores were computed based on weighted combinations of the 8 domain scores, which were transformed to a range from 0 to 100; 0= worst HRQL, 100=best HRQL. Higher scores reflect better health-related functional status. Scoring is standardized using the norm-based scoring method where data is scored in relation to the U.S. general population having a mean of 50 and a standard deviation of 10. Scores below 50 are below the U.S. general population norm and above 50 are above the U.S. general population norm.|Baseline to Months 6, 12, 24, and 36|All randomized and transplanted participants, intent to treat (ITT) population||units on a scale||Standard Error|Mean
848046|NCT00256750|Secondary|Mean Changes in the Value of Physical and Mental Components Using SF-36 From Baseline Up To Months 6, 12, 24, and 36|SF-36 was a Participant-Reported Quality of Life (QoL) Short Form (SF) questionnaire measuring health-related quality of life (HRQL) covering 2 scale measures: physical component summary (PCS) and mental component summary (MCS). PCS represented by 4 domains: physical function, role limitations due to physical problems, pain, and general health perception. MCS represented by 4 domains: vitality, social function, role limitations due to emotional problems, and mental health. Their scores were computed based on weighted combinations of the 8 domain scores, which were transformed to a range from 0 to 100; 0= worst HRQL, 100=best HRQL. Higher scores reflect better health-related functional status. Scoring is standardized using the norm-based scoring method where data is scored in relation to the U.S. general population having a mean of 50 and a standard deviation of 10. Scores below 50 are below the U.S. general population norm and above 50 are above the U.S. general population norm.|Baseline to Months 6, 12, 24,and 36|All randomized and transplanted participants, intent to treat (ITT) population||units on a scale||Standard Deviation|Mean
848047|NCT00256750|Secondary|Mean Relative to an Identified Distribution (Ridit) Value of Symptom Occurrence and Symptom Distress Using Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSDS-59R)|The Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSD-59R) was used to assess the occurrence (never, occasionally, regularly, almost always, always) and distress (0=no distress to 4=terrible distress) of symptoms associated with immunosuppressive therapies. Ridit (relative to an identified distribution) analysis (Fleiss JL. Statistical methods for rates and proportions. New York: John Wiley & Sons, Inc. 1991) was used. Ridit scores were calculated at baseline and at 6, 12, 24, and 36 months for overall symptom occurrence score and overall symptom distress. The Ridit score reflects the probability that a score observed for an individual randomly selected from a group would be higher (worse symptom) than a score observed for a randomly selected individual from the reference group. The reference group was constituted by the frequency distribution of the responses of all participants on all items at baseline. The ridit of the reference group is by definition, 0.5.|Months 6, 12, 24, 36|All randomized and transplanted participants, intent to treat (ITT) population.||Ridit score||Standard Error|Mean
848048|NCT00256750|Secondary|Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire|SF-36 was a Participant-Reported Quality of Life (QoL) Short Form (SF) questionnaire measuring health-related quality of life (HRQL) covering 2 scale measures: physical component summary (PCS) and mental component summary (MCS). PCS represented by 4 domains: physical function, role limitations due to physical problems, pain, and general health perception. MCS represented by 4 domains: vitality, social function, role limitations due to emotional problems, and mental health. Their scores were computed based on weighted combinations of the 8 domain scores, which were transformed to a range from 0 to 100; 0= worst HRQL, 100=best HRQL. Higher scores reflect better health-related functional status. Scoring is standardized using the norm-based scoring method where data is scored in relation to the U.S. general population having a mean of 50 and a standard deviation of 10. Scores below 50 are below the U.S. general population norm and above 50 are above the U.S. general population norm.|Months 6, 12, 24, 36|All randomized and transplanted participants, intent to treat (ITT) population||units on a scale||Standard Deviation|Mean
848070|NCT00256750|Secondary|Percent of Participants With Incidence of New Onset Diabetes Mellitus by Month 36|The incidence of new onset diabetes mellitus defined as participants who developed diabetes mellitus after randomization and transplantation. Participants that did not have diabetes prior to randomization were determined to have new onset diabetes mellitus if (i) the participant received an anti-diabetic medication for a duration of at least 30 days or (ii) at least two fasting plasma glucose (FPG) tests indicate that FPG is >=126 mg/dL (7.0 mmol/L). New onset diabetes mellitus (NODM) = post-transplant diabetes mellitus (PTDM)|Week 4 post-transplantation to Month 36|All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component||percentage of participants||95% Confidence Interval|Number
848049|NCT00256750|Secondary|Mean Value of Physical and Mental Components Using SF-36 Questionnaire|SF-36 was a Participant-Reported Quality of Life (QoL) Short Form (SF) questionnaire measuring health-related quality of life (HRQL) covering 2 scale measures: physical component summary (PCS) and mental component summary (MCS). PCS represented by 4 domains: physical function, role limitations due to physical problems, pain, and general health perception. MCS represented by 4 domains: vitality, social function, role limitations due to emotional problems, and mental health. Their scores were computed based on weighted combinations of the 8 domain scores, which were transformed to a range from 0 to 100; 0= worst HRQL, 100=best HRQL. Higher scores reflect better health-related functional status. Scoring is standardized using the norm-based scoring method where data is scored in relation to the U.S. general population having a mean of 50 and a standard deviation of 10. Scores below 50 are below the U.S. general population norm and above 50 are above the U.S. general population norm.|Months 6, 12, 24, 36|All randomized and transplanted participants, intent to treat (ITT) population||units on a scale||Standard Deviation|Mean
848050|NCT00256750|Secondary|Number of Participants Treated for Acute Rejection (AR) Regardless of Histological Findings by Month 36|Allograft rejection includes any episode of rejection including: clinically suspected rejection, treated rejection, any central biopsy-proven acute rejection (BPAR), and acute rejection (AR: a subset of BPAR) defined as central biopsy-proven rejection that was either clinically suspected by protocol-defined reasons or by other reasons and was treated. Acute rejection (AR) defined as a clinico-pathological event requiring clinical evidence ( either an unexplained rise of serum creatinine ≥ 25% from baseline creatinine or an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remained elevated within 14 days post-transplantation and clinical suspicion of AR) and renal biopsy confirmation biopsy demonstrating a Banff 97 working classification of kidney transplant pathology classification of Grade IA or greater, with higher scores indicating more severe rejection. Only the highest Banff grade for each participant was counted.|Randomization to Month 36|All randomized and transplanted participants, intent to treat (ITT) population||participants|||Number
848051|NCT00256750|Secondary|Percent of Participants With Subclinical Rejection at Month 12|Subclinical rejection defined as histological findings by the central pathologist consistent with acute rejection, but lacking its clinical correlate. Acute rejection defined as a clinico-pathological event requiring clinical evidence and renal biopsy confirmation demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection. Only the episode with the highest Banff grade for each participant was counted. Clinical evidence defined if either a or b was satisfied: a) an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b) an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remained elevated within 14 days post-transplantation and clinical suspicion of acute rejection existed. Allograft biopsies were evaluated by a blinded central independent pathologist using Banff 97 working classification of kidney transplant pathology.|Month 12|All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component||percentage of participants||95% Confidence Interval|Number
848052|NCT00256750|Secondary|Number of Participants Who Recovered Completely From an Episode of Acute Rejection (AR) by Month 12|Acute rejection (AR) = a clinico-pathological event requiring clinical evidence and renal biopsy confirmation demonstrating a Banff 97 classification of Grade IA or greater. Clinical evidence = if either a or b was satisfied: a: an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b: an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remains elevated within 14 days post-transplantation and clinical suspicion of acute rejection exists. Complete recovery following AR defined as serum creatinine [SCr] levels returned to baseline. Recovery calculated using 2 algorithms: Algorithm 1 = last laboratory measurement prior to onset of AR (baseline and first laboratory measurement after 84 days since onset of AR = resolution); Algorithm 2 = lowest laboratory measurement on or after transplantation and prior to onset day of AR (baseline and lowest laboratory measurement after onset on first AR up to Month 12 = resolution)|Randomization to Month 12|All randomized, transplanted, and treated participants; intent to treat (ITT) population with at least one episode of AR up to Month 12||participants|||Number
848053|NCT00256750|Secondary|Percent of Participants With Corticosteroid Resistant Acute Rejection (AR) by Month 36|Steroid-resistant acute rejection (AR) defined as the use of lymphocyte-depletion therapy following treatment with corticosteroids. AR defined as a clinico-pathological event requiring clinical evidence and renal biopsy confirmation demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection. Clinical evidence defined: either a or b was satisfied: a) an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b) an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remained elevated within 14 days post-transplantation and clinical suspicion of acute rejection existed. Allograft biopsies were evaluated by a blinded central independent pathologist using Banff 97 international standardized histopathological working classification of kidney transplant pathology. Only the episode with the highest Banff grade for each participant was counted.|Randomization to Month 36|All randomized and transplanted participants, intent to treat (ITT) population||percentage of participants|||Number
848054|NCT00256750|Secondary|Percent of Participants Using Lymphocyte Depleting Therapy (LDT) for the Initial Treatment of Acute Rejection (AR) by Month 36|The use of LDT (thymoglobulin or antithymocyte gamma globulin [ATGAM]) was permitted only for participants randomized to cyclosporine (CsA) who experienced impaired renal allograft function and anticipated delayed graft function following transplantation. Acute rejection (AR) defined as a clinico-pathological event requiring clinical evidence (an unexplained rise of serum creatinine ≥ 25% from baseline creatinine or an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remained elevated within 14 days post-transplantation and clinical suspicion of acute rejection existed) and biopsy confirmation. AR defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection. Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Only the episode with the highest Banff grade for each participant was counted.|Randomization to Month 36|All randomized and transplanted participants, intent to treat (ITT) population||percentage of participants|||Number
848284|NCT00121641|Other Pre-specified|Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point||x 10^3 c/µL||Standard Error|Mean
848055|NCT00256750|Secondary|Percent of Participants Using Polyclonal Antilymphocyte Preparations for Impaired Renal Function and Anticipated Delayed Graft Function by Month 12|A participant was considered to have delayed graft function (DGF), if treated with dialysis within the first week (Day 1 - 8) after transplantation. The use of polyclonal antilymphocyte preparations (LDT) was permitted only for participants randomized to cyclosporine (CsA) who experienced impaired renal allograft function and anticipated DGF following transplantation and were not permitted in belatacept-treated participants, except for the treatment of acute rejection. Participants treated with LDT began CsA at the discretion of the investigator by Day 7. LDT could also have been used in participants who met >= 1 of the following criteria, observed in the presence of a transplant artery and vein and no evidence of hydronephrosis by sonogram: Urine output < 250 mL/12 hours, no significant improvement (< 1 milligram per deciliter (mg/dL)) in serum creatinine from baseline value over the first 24 - 72 hours post-transplant, or dialysis treatment.|Randomization to Month 12|All randomized and transplanted participants, intent to treat (ITT) population||percentage of participants||95% Confidence Interval|Number
848056|NCT00256750|Secondary|Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36|Acute rejection was defined as a clinico-pathological event requiring clinical evidence and renal biopsy confirmation demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection. Clinical evidence defined: if either a or b was satisfied: a) an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b) an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remains elevated within 14 days post-transplantation and clinical suspicion of acute rejection exists. Allograft biopsies were evaluated by a blinded central independent pathologist using Banff 97 working classification of kidney transplant pathology. Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Only the episode with the highest Banff grade for each participant was counted.|Randomization to Month 36|All randomized and transplanted participants, intent to treat (ITT) population||participants|||Number
848057|NCT00256750|Secondary|Percent of Participants With Prevalence of Acute Rejection (AR) by Month 36|Prevalence of AR = participants with the stated definition of AR at any given time. AR defined as a clinico-pathological event requiring clinical evidence and renal biopsy confirmation demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection. Only the episode with the highest Banff grade for each participant was counted. Clinical evidence = if either a or b was satisfied: a: an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b: an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remains elevated within 14 days post-transplantation and clinical suspicion of acute rejection exists. Allograft biopsies were evaluated by a blinded central independent pathologist using Banff 97 working classification of kidney transplant pathology. Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification.|Randomization to Month 36|All randomized and transplanted participants, intent to treat (ITT) population||percentage of participants||95% Confidence Interval|Number
848058|NCT00256750|Secondary|Mean Value of Lipid Parameters|Lipid parameters included total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, non-HDL cholesterol, and triglycerides (TGs).|Months 12, 24, 36|All randomized and transplanted participants, intent-to-treat (ITT) population||mg/dL||Standard Deviation|Mean
848059|NCT00256750|Secondary|Percent of Participants Using At Least One Anti-Hyperlipidemic Medication|This analysis is based on all participants who were followed up at least 1092 days after transplantation.|Month 36|All randomized and transplanted participants, intent-to-treat (ITT) population; Completer analysis is based on all participants who have been followed up at least 1092 days after transplantation.||percentage of participants||95% Confidence Interval|Number
848060|NCT00256750|Secondary|Number of Participants With Antihyperlipidemic Medication by Intensity Level|An intensity level was associated with the dose level of the statin based anti-hyperlipidemic agent. Any other agent (i.e., non-statin therapy) used as an antihyperlipidemic were considered Level I treatment intensity. Multiple daily dose levels during a period were averaged to compute the daily dose during that period. Level I = 20 mg fluvastatin (flu), 10 mg lovastatin (lova), 10 mg pravastatin (prav), 5-10 mg simvastatin (sim); Level II = 10 mg atorvastatin (atorv), 40 mg flu, 20 mg lova, 20 mg prav, 5 mg rosuvastatin (rosu), 20 mg sim, 10/10 vytorin; Level III = 20 mg atorv, 80 mg flu, 40 mg lova, 40 mg prav, 10 mg rosu, 40 mg sim, 10/20 vytorin; Level IV = 40 mg atorv, 80 mg lova, 80 mg prav, 20 mg rosu, 80 mg sim, 10/40 vytorin; Level V = 80 mg atorv, 40 mg rosu, 10/80 vytorin. Concomitant use of a statin and an agent of another class elevated the intensity level of the statin therapy by 1 level; therefore, an intensity level of greater than V was possible.|Month 36|All randomized and transplanted participants that received at least one hyperlipidemic medication; Completer analysis is based on all participants who have been followed up at least 1092 days after transplantation.||participants|||Number
848061|NCT00256750|Secondary|Percent of Participants With Controlled Dyslipidemia at Month 12|Prevalence of controlled dyslipidemia = the proportion of participants at any given time who met the stated definition of dyslipidemia. Dyslipidemia defined in accordance with recent guidelines from the National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF-K/DOQI). Dyslipidemia defined as hypertriglyceridemia (TGs >= 500 milligrams/deciliter (mg/dL) [5.65 mmol/L]), hypercholesterolemia (LDL >= 100 mg/dL [2.59 mmol/L]), or elevated non-HDL (non-HDL >= 130 mg/dL [3.36 mmol/L]) in the presence of high TGs (TGs >= 200 mg/dL [2.26 mmol/L]). Controlled dyslipidemia defined as participants who received successful pharmacologic treatment for 1 of the above stated dyslipidemias, and their lipid values fell below the thresholds described. TG = triglyceride; LDL = low density lipoprotein; HDL = high density lipoprotein; millimole/Liter (mmol/L). For 95% CI within each group, normal approximation is used if N >=5. Otherwise exact method is used.|Month 12|All randomized and transplanted participants, intent-to-treat (ITT) population||percentage of participants||95% Confidence Interval|Number
848062|NCT00256750|Secondary|Percent of Participants With Prevalence of Dyslipidemia at Month 12|The prevalence of dyslipidemia was defined as the proportion of participants at any given time who met the definition of dyslipidemia. Dyslipidemia defined in accordance with recent guidelines from the National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF-K/DOQI). Dyslipidemia defined as hypertriglyceridemia (TGs >= 500 milligrams/deciliter (mg/dL) [5.65 mmol/L]), hypercholesterolemia (LDL >= 100 mg/dL [2.59 mmol/L]), or elevated non-HDL (non-HDL >= 130 mg/dL [3.36 mmol/L]) in the presence of high TGs (TGs >= 200 mg/dL [2.26 mmol/L]). TG = triglyceride; LDL = low density lipoprotein; HDL = high density lipoprotein; millimole/Liter (mmol/L). For 95% CI within each group, normal approximation is used if N >=5. Otherwise exact method is used.|Month 12|All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component||percentage of participants||95% Confidence Interval|Number
848063|NCT00256750|Secondary|Percent of Non-dyslipidemic Participants With Incidence of Dyslipidemia Post-Transplantation by Month 12|Incidence of dyslipidemia was defined as the proportion of participants who developed dyslipidemia after randomization and transplantation. Dyslipidemia was defined in accordance with recent guidelines from the National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF-K/DOQI). Dyslipidemia = hypertriglyceridemia (TGs >= 500 milligrams/deciliter (mg/dL) [5.65 mmol/L]), hypercholesterolemia (LDL >= 100 mg/dL [2.59 mmol/L]), or elevated non-HDL (non-HDL >= 130 mg/dL [3.36 mmol/L]) in the presence of high TGs (TGs >= 200 mg/dL [2.26 mmol/L]). The TG = triglyceride; LDL = low density lipoprotein; HDL = high density lipoprotein; millimole/Liter (mmol/L). For 95% CI within each group, normal approximation is used if N >=5. Otherwise exact method is used.|Randomization to Month 12|All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component||percentage of participants||95% Confidence Interval|Number
848064|NCT00256750|Secondary|Percent of Participants With Prevalence of Controlled Hypertension at Month 12|The prevalence of controlled hypertension was defined as the proportion of participants at any given time who met the definition of controlled hypertension. Controlled hypertension was defined as a SBP < 130 mm Hg and a DBP < 80 mm Hg while receiving an antihypertensive medication for the indication of hypertension or receiving an antihypertensive medication for another indication with a medical history of hypertension. Participants with a SBP < 130 mm Hg and a DBP < 80 mm Hg who were prescribed an antihypertensive medication(s) for an indication(s) other than hypertension (eg, beta blockers for migraine prophylaxis) with no medical history of hypertension were not considered to have either hypertension or controlled hypertension. Systolic blood pressure = SBP; Diastolic blood pressure = DBP|Month 12|All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component||percentage of participants||95% Confidence Interval|Number
848065|NCT00256750|Secondary|Percent of Participants at Baseline With Controlled Hypertension Post Transplantation by Month 12|Controlled hypertension was defined as a SBP < 130 mm Hg and a DBP < 80 mm Hg while receiving an antihypertensive medication for the indication of hypertension or receiving an antihypertensive medication for another indication with a medical history of hypertension. Participants with a SBP < 130 mm Hg and a DBP < 80 mm Hg who were prescribed an antihypertensive medication(s) for an indication(s) other than hypertension (eg, beta blockers for migraine prophylaxis) with no medical history of hypertension were not considered to have either hypertension or controlled hypertension. Systolic blood pressure = SBP; Diastolic blood pressure = DBP|Day 1 to Month 12|All randomized, transplanted, and treated participants; intent to treat (ITT) population with baseline hypertension||percentage of participants||95% Confidence Interval|Number
848066|NCT00256750|Secondary|Mean Systolic Blood Pressure and Diastolic Blood Pressure|Blood pressure was measured in millimeters of mercury (mmHg). Blood pressure was measured soon after the participant arrived and sat quietly at rest for 10 minutes. 3 consecutive seated blood pressure readings were made at least 1 minute apart.|Months 12, 24, 36|All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component||mmHg||Standard Deviation|Mean
848067|NCT00256750|Secondary|Percent of Participants With Prevalence of Hypertension Post-Transplantation at Month 12|The prevalence of hypertension was defined as the proportion of participants at any given time who meet the definition of hypertension. Hypertension defined according to the Seventh Report of the Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure for participants with chronic kidney disease. This definition is based upon SBP ≥ 130 mm Hg or DBP ≥ 80 mm Hg. Systolic blood pressure = SBP; Diastolic blood pressure = DBP|Month 12|All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component||percentage of participants||95% Confidence Interval|Number
848068|NCT00256750|Secondary|Percent of Participants With Incidence of Hypertension Post-Transplantation at Month 12|The incidence of hypertension was defined as the proportion of participants who developed hypertension after randomization and transplantation. Specifically, the incidence of hypertension was assessed only after the Week 4 visit. This period allowed for adequate stabilization and resolution of transient changes. If participants received antihypertensive medication for the indication of hypertension at this (or later) time point, they were considered to have developed hypertension. Hypertension was defined according to the Seventh Report of the Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure for subjects with chronic kidney disease. This definition was based upon SBP ≥ 130 mm Hg or DBP ≥ 80 mm Hg. Systolic blood pressure = SBP; Diastolic blood pressure = DBP|Month 12|All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component||percentage of participants||95% Confidence Interval|Number
848069|NCT00256750|Secondary|Percent of Participants Using At Least One Anti-Hypertensive Medication to Control Hypertension at Month 36|This analysis was based on all participants who had been followed up at least 1092 days after transplantation. Hypertension was defined in according to the Seventh Report of the Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure for participants with chronic kidney disease. This definition was based upon SBP ≥ 130 mm Hg or DBP ≥ 80 mm Hg. In addition, all participants who had a SBP < 130 mm Hg and a DBP < 80 mm Hg who received an antihypertensive medication(s) for the indication of hypertension or with a medical history of hypertension were included in this definition. Systolic blood pressure = SBP; Diastolic blood pressure = DBP|Month 36|All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component||percentage of participants||95% Confidence Interval|Number
848071|NCT00256750|Secondary|Mean Change in Calculated Glomerular Filtration Rate (cGFR) From Month 6 to Month 12|Calculated glomerular filtration rate (cGFR) was used to assess renal function (as measured by the estimated creatinine clearance) using the following modification of diet in renal disease (MDRD) formula: MDRD: GFR = 170 x [SCr/0.95]^(-0.999) x [Age]^(-0.176) x [0.762 if participant is female] x [1.180 if participant is black] x [BUN]^(-0.170) x [Alb]^(+0.318); Age in years; Alb = Albumin in g/dL; SCr = Serum creatinine in mg/dL; BUN = Blood urea nitrogen in mg/dL; cGFR = mL/min/1.73m^2|Month 6 to Month 12|All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component||mL/Min/1.73 m^2||Standard Deviation|Mean
848072|NCT00256750|Secondary|Mean Value of the Calculated Glomerular Filtration Rate (cGFR) With Imputation|Calculated glomerular filtration rate (cGFR) was used to assess renal function (as measured by the estimated creatinine clearance) using the following modification of diet in renal disease (MDRD) formula: MDRD: GFR = 170 x [SCr/0.95]^(-0.999) x [Age]^(-0.176) x [0.762 if participant is female] x [1.180 if participant is black] x [BUN]^(-0.170) x [Alb]^(+0.318); Age in years; Alb = Albumin in g/dL; SCr = Serum creatinine in mg/dL; BUN = Blood urea nitrogen in mg/dL; cGFR = mL/min/1.73m2|Months 6, 12, 24, 36|All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component||mL/min/1.73 m^2||Standard Deviation|Mean
848073|NCT00256750|Secondary|Percent of Participants With a Measured Glomerular Filtration Rate (mGFR) Less Than 60 mL/Min/1.73 m^2 at Month 12|Measured glomerular filtration rate (mGFR) is the direct measurement of renal function and was assessed by measurement of the clearance of a true glomerular filtration marker (non-radiolabeled iothalamate) using a validated procedure. A GFR of 60 mL/min/1.73 m^2 was used as the approximate equal of the threshold values of serum creatinine (SCr) of 1.5 milligrams per deciliter (mg/dL).|Month 12|All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component||percentage of participants||95% Confidence Interval|Number
848074|NCT00256750|Secondary|Percent of Participants With a Decrease in Measured Glomerular Filtration Rate (mGFR) Greater Than or Equal to 10mL/Min/1.73m^2 From Month 3 to Month 12|Measured glomerular filtration rate (mGFR) is the direct measurement of renal function and was assessed by measurement of the clearance of a true glomerular filtration marker (non-radiolabeled iothalamate) using a validated procedure. A change in GFR of at least 10 mL/min/1.73 m^2 was used as the approximate change in serum creatinine (SCr) of at least 0.3 mg/dL. The change component of the composite renal endpoint was assessed from Month 3 to Month 12, since post-transplant renal function is largely stable by Month 3. Month 3 = baseline|Month 3 to Month 12|All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component||percentage of participants||95% Confidence Interval|Number
848075|NCT00256750|Secondary|Mean Change of the Measured Glomerular Filtration Rate (mGFR) From Month 3 to Month 12 and From Month 3 to Month 24|Measured glomerular filtration rate (mGFR) is the direct measurement of renal function and was assessed by measurement of the clearance of a true glomerular filtration marker (non-radiolabeled iothalamate) using a validated procedure. Missing mGRF assessments were imputed to assess renal function. The overall imputation strategy involved a primary imputation method (linear extrapolation and quartile method) followed by 2 secondary imputation methods (regression method and graded quartile method) to assess the robustness of conclusions obtained from the application of the primary imputation method. All imputation methods entailed replacing a missing value with a value drawn from a plausible distribution incorporating theoretical and observed aspects of the data. GFR was measured as mL/min/1.73 m^2.|Month 3 to Month 12; Month 3 to Month 24|All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component||mL/min/1.73m^2||Standard Deviation|Mean
848076|NCT00256750|Secondary|Percent of Participants With Development of Anti-Donor HLA Positive Antibodies by Month 84|Only participants who had non-missing test result for Class I or Class II anti-donor HLA antibodies were included in analysis and only participants who had at least one non-NA test result or finding were counted. This was a cumulative summary (excluding baseline) and once a participant was positive, that participant remained positive for the later time point. Acute rejection (AR) defined: a clinico-pathological event requiring clinical evidence and biopsy confirmation. Clinical evidence defined: if either a or b was satisfied: a: an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b: an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remains elevated within 14 days post-transplantation and clinical suspicion of acute rejection exists. AR defined as allograft biopsies of Banff 97 classification Grade IA or greater (higher scores indicate more severe rejection). Evaluated by blinded central independent pathologist.|Randomization to Month 84|All randomized, transplanted, and treated participants; intent to treat (ITT) population||percentage of participants||95% Confidence Interval|Number
848077|NCT00256750|Secondary|Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36|"Upper limit of normal (ULN). Units per Liter (U/L). Cells per microliter (c/µL). Grams per deciliter (g/dL). Milligrams per deciliter (mg/dL).Cells per Liter (c/L). Milliequivalents/Liter (mEq/L).
Hemoglobin (low): <8.0 g/dL; Platelet count: <50*10^9 c/L; Leukocytes: <2*10^3 c/µL; Alkaline phosphatase (ALP): >5.0*ULN U/L; Alanine aminotransferase (ALT): >5.0*ULN U/L; Asparate aminotransferase (AST): >5.0*ULN U/L; Bilirubin Total: >3.0*ULN mg/dL; Creatinine: >3.0*ULN mg/dL; Calcium Total: low if <7.0 mg/dL or high if >12.5 mg/dL; Bicarbonate: <11.0 mEq/L; Potassium serum: low if <3.0 mEq/L or high if >6.0 mEq/L; Magnesium serum: low is <0.8 mEq/L or high if >2.46 mEq/L; Sodium serum: low if <130.0 mEq/L or high if >155.0 mEq/L; Phosphorus inorganic: <2.0 mg/dL; Albumin: <2 g/dL; Uric acid: >10 mg/dL; Protein urine: >=3+"|Baseline to Month 36|All randomized, transplanted, and treated participants from the original intent-to-treat (ITT) population||participants|||Number
848078|NCT00256750|Secondary|Mean Blood Pressure at Month 84|Blood pressure was measured in millimeters of mercury (mmHg). Blood pressure was measured soon after the participant arrived and sat quietly at rest for 10 minutes. 3 consecutive seated blood pressure readings were made at least 1 minute apart.|Month 84|All randomized, transplanted, and treated participants from the original intent-to-treat (ITT) population who continued on assigned therapy into the long-term extension phase (ITT-LTE).||mmHg||Standard Deviation|Mean
848079|NCT00256750|Secondary|Number of Participants With Adverse Events of Special Interest by Month 84|Prospectively identified events of special interest which were a subset of all AEs, and were either SAEs or non-serious AEs, included the following categories: Serious Infections and Infestations, Thrombolic/embolic events, and Malignancy. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/ abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Time frame is from randomization to the event date, or to the last dose date+56, or to Month 84 (Day 2548), whichever is the earliest.|Randomization to Month 84|All randomized, transplanted, and treated participants from the original intent-to-treat (ITT) population who continued on assigned therapy into the long-term extension phase (ITT-LTE)||participants|||Number
848080|NCT00256750|Secondary|Number of Participants With Serious Adverse Events, Death, Discontinuation Due to Adverse Events by Month 84|Adverse event (AE) defined: any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Serious adverse event (SAE) defined: a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|Randomization to Month 84|All randomized, transplanted, and treated participants from the original intent-to-treat (ITT) population who continued on assigned therapy into the long-term extension phase (ITT-LTE)||participants|||Number
848081|NCT00256750|Secondary|Percent of Participants With Prevalence of Chronic Allograft Nephropathy (CAN) at Month 12|Prevalence of CAN = if participant met any of the following conditions: a: CAN observed in a biopsy either prior to 12 months (including baseline biopsy) or first post 12 months biopsy; b: participant had graft loss during the first year post transplant; c: no biopsy was available post 12 months and CAN not observed in biopsies prior to 12 months, but the measured GFR from Month 3 to Month 12 decreased at least 10 mL/min/1.73m^2; d: no biopsy available either prior to or post 12 months, and the measured GFR (incorporated missing data imputation) from Month 3 to Month 12 decreased at least 10 mL/min/1.73m^2. CAN = All allograft biopsies evaluated for presence and severity of CAN by a blinded central independent pathologist using Banff 97 working classification of kidney transplant pathology. Onset of CAN determined by the biopsy date when it was observed.|Month 12|All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component; Any participant not meeting CAN criteria and who has no biopsy either prior to or post 12 months and no GFR assessment (either measured or calculated) available were excluded from the analyses.||percentage of participants||95% Confidence Interval|Number
848082|NCT00256750|Secondary|Mean Value of the Measured Glomerular Filtration Rate (mGFR)|Measured glomerular filtration rate (mGFR) is the direct measurement of renal function and was assessed by measurement of the clearance of a true glomerular filtration marker (non-radiolabeled iothalamate) using a validated procedure. Missing mGRF assessments were imputed to assess renal function. The overall imputation strategy involved a primary imputation method (linear extrapolation and quartile method) followed by 2 secondary imputation methods (regression method and graded quartile method) to assess the robustness of conclusions obtained from the application of the primary imputation method. All imputation methods entailed replacing a missing value with a value drawn from a plausible distribution incorporating theoretical and observed aspects of the data. GFR was measured as mL/min/1.73 m^2.|Months 3, 12, 24|All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component||mL/min/1.73m^2||Standard Deviation|Mean
848083|NCT00256750|Primary|Percent of Participants Experiencing Acute Rejection (AR) Post-transplant by Month 12|Acute rejection was defined as a clinico-pathological event requiring clinical evidence and biopsy confirmation. Clinical evidence was defined if either a or b was satisfied: a: an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b: an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remains elevated within 14 days post-transplantation and clinical suspicion of acute rejection exists. Allograft biopsies were evaluated by a blinded central independent pathologist using Banff 97 working classification of kidney transplant pathology. Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. AR was defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection. Only the episode with the highest Banff grade for each participant was counted.|Day 1 to Month 12|All randomized, transplanted, and treated participants; intent to treat (ITT) population||percentage of participants||95% Confidence Interval|Number
848084|NCT00256750|Primary|Percent of Participants With a Composite of Measured Glomerular Filtration Rate (mGFR) Less Than 60 mL/Min/1.73 m^2 at Month 12 or With a Decrease in mGFR Greater Than or Equal to 10 mL/Min/1.73m^2 From Month 3 to Month 12|Measured glomerular filtration rate (mGFR) is the direct measurement of renal function and was assessed by measurement of the clearance of a true glomerular filtration marker (non-radiolabeled iothalamate) using a validated procedure. A GFR of 60 mL/min/1.73 m^2 was used as the approximate equal of the threshold values of serum creatinine (SCr) of 1.5 mg/dL. A change in GFR of at least 10 mL/min/1.73 m^2 was used as the approximate change in SCr of at least 0.3 mg/dL. The change component of the composite renal endpoint was assessed from Month 3 to Month 12, since post-transplant renal function is largely stable by Month 3.|Month 12; Month 3 to Month 12|All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component||percentage of participants||95% Confidence Interval|Number
848085|NCT00256750|Primary|Percent of Participants Surviving With a Functioning Graft by Month 12|Graft loss was defined as either functional loss or physical loss (nephrectomy). Functional loss was defined as a sustained level of serum creatinine (SCr) ≥ 6.0 milligrams per deciliter (mg/dL) or 530 micromolar per liter (μmol/L) as determined by the central laboratory for ≥ 4 weeks or ≥ 56 consecutive days of dialysis or impairment of renal function to such a degree that the participant underwent retransplant.|Day 1 to Month 12|All randomized, transplanted, and treated participants; intent to treat (ITT) population||percentage of participants||95% Confidence Interval|Number
848136|NCT00219349|Primary|Penn State Worry Questionnaire||week 14 to week 26||||||
848137|NCT00219349|Primary|GAD Severity Scale||week 14 to week 26||||||
848138|NCT00219349|Primary|Clinical Global Impressions-Severity Index||week 14 to week 26||||||
848139|NCT00219349|Primary|Clinical Global Impressions-Improvement Index||week 26||||||
848285|NCT00121641|Other Pre-specified|Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point||x 10^3 c/µL||Standard Error|Mean
848140|NCT00219349|Primary|Change in Hamilton Anxiety Rating Scale Score|The Hamilton Anxiety Rating Scale is a clinician administered rating scale assessing severity of anxiety from 0 (low) to 64 (high). The greater the magnitude of decrease in score during treatment, the greater the improvement in anxiety.|week 14 to week 26|see above: Patients who completed the CBT phase and started escitalopram treatment||units on a scale||Standard Deviation|Mean
848303|NCT00121641|Secondary|Baseline and Change From Baseline at Week 24 in Postprandial Glucose (PPG) Area Under the Curve (AUC)||Baseline, Week 24|Randomized participants with measure at given time points, Last Observation Carried Forward (LOCF).||mg*min/dL||Standard Error|Mean
848119|NCT00245037|Secondary|Chronic Graft-Versus-Host Disease (cGVHD) Outcome|"Grading of Chronic GVHD:
Limited: Localized skin involvement and/or hepatic dysfunction due to chronic GVHD
Extensive:
One or more of the following:
Generalized skin involvement Liver histology showing chronic aggressive hepatitis, bridging necrosis or cirrhosis Involvement of the eye: Schirmer’s test with <5 mm wetting Involvement of minor salivary glands or oral mucosa demonstrated on labial biopsy Involvement of any other target organ
Chronic GVHD Severity:
Mild: Signs and symptoms of cGVHD do not interfere substantially with function and do not progress once appropriately treated with local therapy or standard systemic therapy.
Moderate: Signs and symptoms of cGVHD interfere somewhat with function despite appropriate therapy or are progressive through first line systemic therapy.
Severe: Signs and symptoms of cGVHD limit function substantially despite appropriate therapy or are progressive through second line systemic therapy"|Years 1, 2 and 3|This is a cumulative incidence of cGVHD at 1 year, 2 years, and 3 years. A total of 99 patients (out of 147) developed cGVHD, 86 patients (87%) with extensive stage cGVHD and 13 patients (13%) with limited stage cGVHD.||percentage of analyzed participants|||Number
848120|NCT00245037|Secondary|Acute Graft-Versus-Host Disease (aGVHD) Outcome|"Grading of Acute GVHD:
Severity of Individual Organ Involvement:
Skin
1 a maculopapular eruption involving less than 25% of the body surface
2 a maculopapular eruption involving 25-50% of the body surface
3 generalized erythroderma
4 generalized erythroderma with bullous formation and/or with desquamation Liver
1 bilirubin 2.0-3.0mg/100mL
2 bilirubin 3-5.9mg/100mL
3 bilirubin 6-14.9mg/100mL
4 bilirubin >15mg/100mL Gut Diarrhea is graded +1 to +4 in severity. Nausea/vomiting and/or anorexia caused by GVHD is assigned as +1 in severity Diarrhea
1 <1000mL of liquid stool/day
2 >1,000mL of stool/day
3 >1,500mL of stool/day
4 2,000mL of stool/day, severe abdominal pain, with or without ileus
Severity of GVHD:
Grade 1 +1 to +2 skin rash; No gut or liver involvement Grade 2 +1 to +3 skin rash;+1 GI involvement and/or +1 liver"|Day 100, Month 6|This is cumulative incidence of grades 2-4 aGVHD at 100 days and at 6 months. Out of the total number of participants, grades 2-4 aGVHD occurred in 79 patients.||percentage of analyzed participants|||Number
848121|NCT00245037|Secondary|Relapse Mortality|The percentage of patients (out of 147 participants) who relapsed at Years 1 and 2. Relapse is defined as the presence of >5% blasts by morphology on a post-transplant bone marrow aspirate.|Years 1 and 2|||percentage of analyzed participants|||Number
848122|NCT00245037|Secondary|Progression-Free Survival|"The percentage of progression-free patients (out of 147 participants) at Years 1, 2, 3, and 5.
Definition of Disease Progression:
MM/Plasma Cell: Increasing bone pain or increase in serum/urine monoclonal protein by 25%.
CLL/NHL/HD: New sites of lymphadenopathy; ≥ 25% increase in lymph node size; Blood or bone marrow involvement with clonal B-cells; Increase of ≥ 25% bone marrow involvement; ≥ 25% increase in blood involvement with clonal B-cells.
AML/ALL: Any incidence of relapse (>5% blasts) by evaluation of the bone marrow aspirate.
CML: Inability to control platelet or granulocyte counts; Increase in baseline number of metaphases demonstrating the Ph+ chromosome by >25%; Any other new cytogenetic abnormality; Transformation to accelerated phase or blast crisis.
MDS/MPD: Any evidence by morphologic or flow cytometric evaluation of the bone marrow aspirate of new blasts (>5%) or worsening cytopenia or cytogenetic evidence of recurrence."|Years 1, 2, 3, and 5|||percentage of analyzed participants|||Number
848123|NCT00245037|Secondary|Overall Survival|The percentage of overall patient survival (out of 147 participants) for Years 1, 2, 3 and 5.|Years 1, 2, 3 and 5|||percentage of analyzed participants|||Number
848124|NCT00245037|Primary|Non-relapse Mortality|Percent of subjects with non-relapse mortality two years after conditioning with busulfan with fludarabine/200 cGy TBI in patients with hematologic malignancies at moderate to high risk for graft rejection and/or relapse of underlying disease.|Two years post-transplant|||Participants|||Count of Participants
848125|NCT00245037|Primary|Regimen-Related Toxicities|Non-hematologic toxicities and adverse experiences ≥ Grade 3 occurrences measured up to day +100 using the NCI Common Toxicity Criteria for Adverse Events v3.0 (CTCAE). Infections and GVHD will be assessed up to 5 years post transplant. The following data represents the number of regimen-related, grade 3 and 4 toxicities that occurred in each category.|5 years post-transplant|||Toxicities|||Number
848126|NCT00241839|Secondary|Change in Uric Acid (UA) Levels: Baseline Less End of Treatment|Subjects on allopurinol are expected to lower their uric acid levels relative to placebo.|Baseline UA levels compared to end of treatment levels (8-10 weeks on allopurinol / placebo)|Change in uric acid from baseline to end of treatment.||mg/dl||Standard Deviation|Mean
848127|NCT00241839|Secondary|Change in Overall Mean BP From Those Obtained by 24 Hour Ambulatory Blood Pressure Measurements (ABPM) 8-10 Weeks Minus Baseline.|Subjects had 24 hr blood pressure monitoring (ABPM) at baseline and treatment end. The readings were averaged and the changes from baseline to treatment end were compared.|Baseline and end of treatment (8-10 weeks on allopurinol / placebo)|We obtained over 90% of those with cuff measures on the 24 hour BP measures (ABPM).||mm Hg||Standard Deviation|Mean
848128|NCT00241839|Primary|Change in Systolic Blood Pressure by Cuff After 8-10 Weeks Minus Baseline|"The systolic BP was taken at Baseline and after 8-10 weeks of treatment on placebo, while on chlorthalidone and potassium chloride. The blood pressure was measured according to Shared Care protocol: 15 minutes of quiet, undisturbed rest with three BP measurements obtained subsequently at 5 minute intervals.
The mean of the second and third reading was the value used for analysis for both the Baseline measurement and the measurement after 8 - 10 weeks of treatment. The dependent variable is baseline value minus ending value.
Measures are in millimeters of mercury (mm hg)"|Measured at 8-10 weeks on allopurinol or placebo|Participants were individuals with essential hypertension (BP 140/90-160/100) on none or up 2 antihypertensive drugs without any other chronic condition or illness. For their data to be included in analysis they had to complete the study (includes baseline to last visit).||mm Hg||Standard Deviation|Mean
848129|NCT00241839|Primary|Change in Diastolic Blood Pressure by Cuff 8-10 Weeks Minus Baseline|"The Diastolic BP was taken at Baseline and after 8-10 weeks of treatment or placebo while on chlorthalidone and potassium chloride. The blood pressure was measured according to Shared Care protocol: 15 minutes of quiet, undisturbed rest with three BP measurements obtained subsequently at 5 minute intervals.
The mean of the second and third reading was the value used for analysis for both the Baseline measurement and the measurement after 8 - 10 weeks of treatment. The dependent variable is baseline value minus ending value.
Measures are in millimeters of mercury (mm hg)"|Measured at 8-10 weeks on allopurinol / placebo|Participants were individuals with essential hypertension (BP 140/90-160/100) on none or up 2 antihypertensive drugs without any other chronic condition or illness. For their data to be included in analysis they had to complete the study (includes baseline to last visit).||mm Hg||Standard Deviation|Mean
848130|NCT00238433|Primary|Therapy-Related Toxicities|The table presented below reflects how many participants (out of 36 total) presented an adverse event related to the treatment regimen within each toxicity category. To review specific adverse events, both related and unrelated to study treatment, please refer to Adverse Events Section.|Through 24 months post transplantation|||Participants|||Count of Participants
848131|NCT00238433|Primary|Disease-Free Survival|The data presented below represents the total number of subjects (out of 36) that reached disease-free survival status during Months 3, 6, 9, 12, 18, and 24 time points.|3, 6, 9, 12, 18, and 24 months post transplantation|||Participants|||Count of Participants
848132|NCT00219349|Secondary|Beck Depression Inventory-II||week 14 to week 26||||||
848133|NCT00219349|Secondary|Hamilton Rating Scale for Depression||week 14 to week 26||||||
848134|NCT00219349|Primary|Change in Hamilton Anxiety Scale Score||week 14 to week 26||||||
848135|NCT00219349|Primary|State-Trait Anxiety Inventory||week 14 to week 26||||||
848141|NCT00211237|Secondary|Rate of Subsequent Vertebral Body Fractures|Based on patients with at least 7 analyzable vertebrae.|1 month and 12 months|The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.||percentage of participants|||Number
848142|NCT00211237|Secondary|Rate of Subsequent Vertebral Body Fractures||1 month|Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.||percentage of participants|||Number
848143|NCT00211237|Secondary|Rate of Study Treatment-related Adverse Events Till Study Completion|"The study treatment-related AEs were defined as follows:
Related defined as the AE had a direct relationship to a Sponsor medical device used in the study patient.
Possibly related defined as the AE may have had a relationship to a Sponsor medical device but an alternative cause may be equally or less likely associated.
Unrelated defined as the AE was due to the underlying indication or disease state or to concomitant medication or therapy not related to any Sponsor device.
Unknown defined as the relationship of the AE to a Sponsor device could not be determined."|12 months|All of randomized subjects were included in safety population analysis.||percentage of participants|||Number
848144|NCT00211237|Secondary|Rate of Study Treatment-related Adverse Events Within 30 Days of Baseline|"The study treatment-related AEs were defined as follows:
Related defined as the AE had a direct relationship to a Sponsor medical device used in the study patient.
Possibly related defined as the AE may have had a relationship to a Sponsor medical device but an alternative cause may be equally or less likely associated.
Unrelated defined as the AE was due to the underlying indication or disease state or to concomitant medication or therapy not related to any Sponsor device.
Unknown defined as the relationship of the AE to a Sponsor device could not be determined."|1 month|All of the randomized subjects were included in safety population analysis.||percentage of participants|||Number
848145|NCT00211237|Secondary|Change in Neurological Status From Baseline (Limb Strength)|The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. Radicular lower limb pain was assessed the presence of paresthesia, weakness, and/or painful straight leg raising (SLR).|1 months, 3 months, 6 months, and 12 months|The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.||percentage of participants|||Number
848146|NCT00211237|Secondary|Change in Neurological Status From Baseline (Limb Strength)|The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. Radicular lower limb pain was assessed the presence of paresthesia, weakness, and/or painful straight leg raising (SLR).|1 month|Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.||percentage of participants|||Number
848147|NCT00211237|Secondary|Change in Neurological Status From Baseline (Reflex Strength)|"The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. Evaluation criteria of reflexes (scored 0-3) for patellar and Achilles reflexes as following:
absent = 0, hypoactive = 1, normal = 2, brisk or clonus = 3"|1 months, 3 months, 6 months, and 12 months|The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.||percentage of participants|||Number
848148|NCT00211237|Secondary|Change in Neurological Status From Baseline (Reflex Strength)|"The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. Evaluation criteria of reflexes (scored 0-3) for patellar and Achilles reflexes as following:
absent = 0, hypoactive = 1, normal = 2, brisk or clonus = 3"|1 month|Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.||percentage of participants|||Number
848149|NCT00211237|Secondary|Change in Neurological Status From Baseline (Sensory Examination)|The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. For sensory examination, the Investigator assessed sensory status at baseline and a change from baseline beginning with the most cephalad index level treated through L5.|1 months, 3 months, 6 months, and 12 months|The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.||percentage of participants|||Number
848150|NCT00211237|Secondary|Change in Neurological Status From Baseline (Sensory Examination)|The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. For sensory examination, the Investigator assessed sensory status at baseline and a change from baseline beginning with the most cephalad index level treated through L5.|1 month|Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.||percentage of participants|||Number
848162|NCT00211237|Secondary|Change in Activities of Daily Living - Number of Days in Bed Due to Back Pain in Previous 2 Weeks|The Activities of Daily Living assessment comprised three questions about the effects of back pain or back problems over the previous 2-week period. The patient was asked if they had cut down on usual activities, the number of days in which the patient had cut down on usual activities and the number of days that the patient had spent at least half a day in bed because of back pain or back problems.|Baseline and 1 month|Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.||days||Standard Deviation|Mean
848151|NCT00211237|Secondary|Change in Neurology Status From Baseline (Motor Strength)-Per Protocol|"The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. Evaluation criteria of motor strength (scored 0-5) for rectus abdominis, hip extensors and flexors, knee extensors and flexors, and foot plantar and dorsiflexors as following:
absent voluntary contraction = 0, contractions unable to move joint = 1, movement with gravity eliminated = 2, movement against gravity = 3, movement against resistance = 4, full strength = 5"|1 month, 3 months, 6 months, and 12 months|The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.||percentage of participants|||Number
848152|NCT00211237|Secondary|Change in Neurology Status From Baseline (Motor Strength)|"The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. Evaluation criteria of motor strength (scored 0-5) for rectus abdominis, hip extensors and flexors, knee extensors and flexors, and foot plantar and dorsiflexors as following:
absent voluntary contraction = 0, contractions unable to move joint = 1, movement with gravity eliminated = 2, movement against gravity = 3, movement against resistance = 4, full strength = 5"|1 month|Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.||percentage of participants|||Number
848153|NCT00211237|Secondary|Back Pain Analgesics Used||Baseline, 7 days, 1 month, 3 months, 6 months, and 12 months|The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.||percentage of participants|||Number
848154|NCT00211237|Secondary|Back Pain Analgesics Used||Baseline, 7 days, and 1 month|Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.||percentage of participants|||Number
848155|NCT00211237|Secondary|Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio|Index spinal deformity was measured by Kyphotic angle, local Cobb angle, thoracic and lumbar Cobb angle, and anterior, middle and posterior vertebral body heights for each index VCF. Index Vertebral Body Height Ratio (VBHR) was defined as index vertebra height divided by the average of normal superior and inferior adjacent vertebrae.|Baseline, post-operation, 1 month, and 12 months|The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.||ratio||Standard Deviation|Mean
848156|NCT00211237|Secondary|Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio|Index spinal deformity was measured by Kyphotic angle, local Cobb angle, thoracic and lumbar Cobb angle, and anterior, middle and posterior vertebral body heights for each index VCF. Index Vertebral Body Height Ratio (VBHR) was defined as index vertebra height divided by the average of normal superior and inferior adjacent vertebrae.|Baseline and 1 month|Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.||ratio||Standard Deviation|Mean
848157|NCT00211237|Secondary|Index Spinal Deformity Change Measured by Index Vertebral Body Angles|Index spinal deformity was measured by Kyphotic angle, local Cobb angle, thoracic and lumbar Cobb angle, and anterior, middle and posterior vertebral body heights for each index VCF.|Baseline, post-operation, 1 month, and 12 months|The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.||degrees||Standard Deviation|Mean
848158|NCT00211237|Secondary|Index Spinal Deformity Change Measured by Index Vertebral Body Angles From Baseline to 1 Month|Index spinal deformity was measured by Kyphotic angle, local Cobb angle, thoracic and lumbar Cobb angle, and anterior, middle and posterior vertebral body heights for each index VCF.|Baseline and 1 month|Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.||degrees||Standard Deviation|Mean
848159|NCT00211237|Secondary|Ambulatory Status Change|Ambulatory status was assessed using a three-category system, fully ambulatory, ambulatory with assistance, or not ambulatory.|Baseline, 7 days, 1 month, 3 months, 6 months, and 12 months|The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.||percentage of participants|||Number
848160|NCT00211237|Secondary|Ambulatory Status Change From Baseline to One Month|Ambulatory status was assessed using a three-category system, fully ambulatory, ambulatory with assistance, or not ambulatory.|1 month|Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.||percentage of participants|||Number
848161|NCT00211237|Secondary|Change in Activities of Daily Living - Number of Days in Bed Due to Back Pain in Previous 2 Weeks|The Activities of Daily Living assessment comprised three questions about the effects of back pain or back problems over the previous 2-week period. The patient was asked if they had cut down on usual activities, the number of days in which the patient had cut down on usual activities and the number of days that the patient had spent at least half a day in bed because of back pain or back problems.|Baseline, 1 month, 3 months, 6 months, and 12 months|The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.||days||Standard Deviation|Mean
848304|NCT00121641|Secondary|Percentage of Participants Achieving Therapeutic Glycemic Response (A1C < 7.0%) at Week 24||Week 24|Randomized Participants with measurement at time point, Last Observation Carried Forward (LOCF)||percentage of participants|||Number
848163|NCT00211237|Secondary|Change in Activities of Daily Living - Number of Days With Reduced Activities Due to Back Pain in Previous 2 Weeks|The Activities of Daily Living assessment comprised three questions about the effects of back pain or back problems over the previous 2-week period. The patient was asked if they had cut down on usual activities, the number of days in which the patient had cut down on usual activities and the number of days that the patient had spent at least half a day in bed because of back pain or back problems.|Baseline, 1 month, 3 months, 6 months, and 12 months|The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.||days||Standard Deviation|Mean
848164|NCT00211237|Secondary|Change in Activities of Daily Living - Number of Days With Reduced Activities Due to Back Pain in Previous 2 Weeks|The Activities of Daily Living assessment comprised three questions about the effects of back pain or back problems over the previous 2-week period. The patient was asked if they had cut down on usual activities, the number of days in which the patient had cut down on usual activities and the number of days that the patient had spent at least half a day in bed because of back pain or back problems.|Baseline and 1 month|Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.||days||Standard Deviation|Mean
848165|NCT00211237|Secondary|Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks|The Activities of Daily Living assessment comprised three questions about the effects of back pain or back problems over the previous 2-week period. The patient was asked if they had cut down on usual activities, the number of days in which the patient had cut down on usual activities and the number of days that the patient had spent at least half a day in bed because of back pain or back problems.|Baseline, 1 month, 3 months, 6 months, and 12 months|The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.||percentage of participants|||Number
848166|NCT00211237|Secondary|Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks|The Activities of Daily Living assessment comprised three questions about the effects of back pain or back problems over the previous 2-week period. The patient was asked if they had cut down on usual activities, the number of days in which the patient had cut down on usual activities and the number of days that the patient had spent at least half a day in bed because of back pain or back problems.|Baseline and 1 month|Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.||percentage of participants|||Number
848167|NCT00211237|Secondary|Change in Quality of Life|The SF-36 were used to assess quality of life. The SF-36 results were summarized into two components, a physical component summary score (PCS) (0-100) and a mental component summary score (MCS) (0-100). The higher the score, the better the quality of life.|Baseline, 1 month, 3 months, 6 months, and 12 months|The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.||units on a scale||Standard Deviation|Mean
848168|NCT00211237|Secondary|Change in Quality of Life.|The SF-36 was used to assess quality of life. The SF-36 results were summarized into two components, a physical component summary score (PCS) (0-100) and a mental component summary score (MCS) (0-100). The higher the score, the better the quality of life.|Baseline and 1 month|Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.||units on a scale||Standard Deviation|Mean
848169|NCT00211237|Secondary|Change in Back Pain|Back pain was assessed on a NRS from 0 (no pain) to 10 (worst possible pain).|Baseline, 1 month, 3 months, 6 months, and 12 months|The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.||units on a scale||Standard Deviation|Mean
848170|NCT00211237|Secondary|Change in Back Pain|Back pain was assessed on a 10-point Numerical Rating Scale (NRS) from 0 (no pain) to 10 (worst possible pain).|Baseline and 1 month|Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.||units on a scale||Standard Deviation|Mean
848171|NCT00211237|Secondary|Change in Functional Status Assessed With the Karnofsky Performance Scale|The Karnofsky Performance Scale rates a patient on an 11-step scale from 0 (dead) to 100 (normal, no complaints, no evidence of disease).|Baseline, 1 month, 3 months, 6 months, and 12 months|The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.||units on a scale||Standard Deviation|Mean
848172|NCT00211237|Secondary|Change in Functional Status Assessed With the Karnofsky Performance Scale|The Karnofsky Performance Scale rates a patient on an 11-step scale from 0 (dead) to 100 (normal, no complaints, no evidence of disease).|Baseline and 1 month|Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.||units on a scale||Standard Deviation|Mean
848173|NCT00211237|Secondary|Change in Roland-Morris Disability Questionnaire Score|Roland-Morris Disability Questionnaire (RMDQ) was used to assess the physical disability due to back pain. The best score is 0 (no disability) and worst is 24 (maximum disability).|Baseline, 1 month, 3 months, 6 months, and 12 months|The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.||units on a scale||Standard Deviation|Mean
848174|NCT00211237|Primary|The Functional Status, as Measured by the Roland-Morris Disability Questionnaire (RDQ) at 1 Month|"The full scale name is the Roland-Morris Disability Questionnaire; it is a validated measure of physical disability due to back pain.
The best score is 0 (no disability) and worst is 24 (maximum disability)"|Baseline and 1 Month|The analyses of change from Baseline included only patients in the modified Intent-to-Treat (mITT) population who provided evaluable data at both Baseline and at 1 month after receipt of the initially assigned study treatment.||score on a scale||95% Confidence Interval|Mean
848175|NCT00205504|Secondary|Inflammatory Marker Changes, Soluble Vascular Cell Adhesion Molecule (sVCAM) and Soluble Intercellular Adhesion Molecule (sICAM), Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women|These inflammatory markers are assessed through blood analysis of Soluble Vascular Cell Adhesion Molecule (sVCAM) and soluble intercellular adhesion molecule (sICAM).|Baseline and 6 months|||ng/mL||Standard Deviation|Mean
848176|NCT00205504|Secondary|Changes in Waist Circumference Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women||Baseline and 6 months|||cm||Standard Deviation|Mean
848177|NCT00205504|Secondary|Changes in Body Mass Index (BMI) Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women|Body Mass Index is a calculation of height and weight: kg/m²|Baseline and 6 months|||kg/m²||Standard Deviation|Mean
848178|NCT00205504|Secondary|Changes in Blood Pressure Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women||Baseline and 6 months|||mm Hg||Standard Deviation|Mean
848179|NCT00205504|Secondary|Inflammatory Marker Changes (MCP-1) Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women|Inflammatory marker is assessed through blood analysis for Monocyte chemotactic protein-1 (MCP-1).|Baseline and 6 months|||pg/mL||Standard Deviation|Mean
848180|NCT00205504|Secondary|Changes in Waist-to-Hip Ratio Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women|Waist-to-hip ratio is assessed through calculated ratio of waist and hip circumference.|Baseline and 6 months|||ratio||Standard Deviation|Mean
848181|NCT00205504|Secondary|Changes in Estrogen Metabolites (Plasma) Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women||Baseline and 6 months|||pg/mL||Standard Deviation|Mean
848182|NCT00205504|Secondary|Inflammatory Marker Changes, High Sensitive C-reactive Protein (Hs-CRP) and Adiponectin, Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women|Inflammatory markers are assessed through blood analysis for C-reactive protein (hs-CRP) and adiponectin.|Baseline and 6 months|||ng/mL||Standard Deviation|Mean
848183|NCT00205504|Secondary|Changes in Lipid Profile Compared Associated With OC Use Among (1) Obese Women and (2) Lean Women|The lipid profile is assessed through blood sample analysis for low-density lipoprotein (LDL), Triglycerides and high-density lipoprotein (HDL).|Baseline and 6 months|||mg/dL||Standard Deviation|Mean
848184|NCT00205504|Primary|Changes in Insulin Sensitivity Associated With Oral Contraceptive (OC) Use Compared Among (1) Obese Women and (2) Lean Women|Insulin sensitivity was assessed by frequent sampling intravenous glucose tolerance test (FSIVGTT).|Baseline and 6 months|||mIU/L||Standard Deviation|Mean
848185|NCT00187889|Secondary|Microvascular Coronary Flow Reserve(Adjusted) at Week 16 Adjusted for Baseline Coronary Flow Reserve Comparing the Eplerenone Group to the Placebo Group|Coronary flow reserve is a ratio of coronary blood flow velocity before and after adenosine. The outcome measure is the difference between the coronary flow reserve at 16 weeks adjusted for coronary flow reserve at baseline.|16 weeks|See Primary Outcome. The studied was only powered for the primary outcome. All completers are included per protocol analysis.||difference of ratios (unitless)||Standard Deviation|Mean
848186|NCT00187889|Primary|Epicardial Coronary Artery Endothelial Function (Adjusted) at Week 16 Comparing the Eplerenone Group to the Placebo Group|The primary measure was the relative change in coronary diameter to acetylcholinem (ACH) at 16 weeks adjusted for baseline reactivity to acetylcholine. Change in coronary artery diameter after ACH was measured in mm at baseline and 16 weeks. Percent change at 16 weeks - percent change at baseline was the outcome.|16 weeks|power analysis: Study planned to detect a 12% difference in change from baseline to 16 weeks between treatment groups (SD=14%), in the primary outcome leading to a planned sample size of 22 per group (44 total) for 80% power, P=0.05 2-sided. Study allowed for 6 dropouts, leading to a final N=50 planned (25 per group). Per protocol analysis used.||% change wk16-%change wk0- unitless||Standard Deviation|Mean
848187|NCT00163293|Secondary|Number of Participants With Adverse Events and Serious Adverse Events|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in congenital anomaly/birth defect or any other important medical condition considered serious based on medical and scientific judgement.|Up to 12 months|Safety analysis set included all randomized participants who received at least 1 dose of trial medication.||participants|||Number
848188|NCT00163293|Secondary|Number of Participants With Clinically Significant Laboratory Values|Clinically significant laboratory values were hematology and chemistry tests determined by the investigator to be clinically significant based on the following criteria: Hemoglobin <9.5 g/dL; Erythrocytes <3.0 x 10^6/μL or >6.5 x 10^6/μL; White Blood Count <3000/mm^3 or >20000/mm^3; serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT), gamma-glutamyl transpeptidase (GGT), Total Bilirubin and Glucose >2 times Upper limit of Normal Range (ULNR); Alkaline Phosphatase and Creatine Kinase >3 times ULNR; Creatinine >1.5 times ULN; Potassium >5.0 mmol/L or <3.0 mmol/L; and Sodium >150 mmol/L or 130 mmol/L.|Up to 12 months|Safety analysis set included all randomized participants who received at least 1 dose of trial medication.||participants|||Number
848189|NCT00163293|Secondary|Number of Participants With Clinically Significant Physical Examination Findings|A thorough physical examination was performed consisting of examinations of the following body systems: (1) eyes; (2) ears, nose, throat; (3) lungs/thorax; (4) heart/cardiovascular system; (5) abdomen; (6) skin and mucosae; (7) nervous system; (8) lymph nodes; (9) musculo-skeletal system; (10) physical examinations other than body systems described in (1) to (9). The investigator determined if any of the findings were clinically significant.|Up to 12 months|Safety analysis set included all randomized participants who received at least 1 dose of trial medication.||participants|||Number
848190|NCT00163293|Secondary|Number of Participants With Clinically Significant Vital Signs Findings|Vital signs included body temperature, systolic and diastolic blood pressure and heart rate in beats per minute (bpm). The investigator determined if the result was clinically significant based on the following criteria: Systolic Blood Pressure >130 mmHg or <80 mmHg or a >20 mmHg difference from Baseline; Diastolic Blood Pressure > 85 mmHg; and Resting Heart Rate >140 bpm or <60 bpm or a >30 bpm difference from Baseline.|Up to 12 months|Safety analysis set included all randomized participants who received at least 1 dose of trial medication.||participants|||Number
848191|NCT00163293|Secondary|Quality of Life Assessments as Per Paediatric Asthma Caregiver’s Quality of Life Questionnaire (PACQLQ)|The PACQLQ consists of 13 items divided into two domains: Activity limitations (items 2, 4, 6, 8) and Emotional function (items 1, 3, 5, 7, 9, 10, 11, 12, 13). Caregivers answered each question using a seven-point scale (whereby “1” indicated maximum impairment and “7” indicated no impairment) and recalled their experiences during the previous week. Overall PACQLQ score is equal to the mean of all 13 items for a total possible score of 1 (worst) to 7 (best).|Months 2, 6 and 12|"ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. n in the category is the number of participants with data available at the given time-point."||score on a scale||Standard Deviation|Mean
848192|NCT00163293|Secondary|Quality of Life Assessments as Per Paediatric Asthma Quality of Life Questionnaire, Standardized (PAQLQ[S])|The PAQLQ(S) consists of 23 items divided into three domains: Activity limitations (items 1-3, 19, 22); Symptoms (items 4, 6, 8, 10, 12, 14, 16, 18, 20, 23) and Emotional function (items 5, 7, 9, 11, 13, 15, 17, 21). Participants were asked to answer each question using a seven-point scale (where “1” indicated maximum impairment and “7” indicated no impairment) and recall their experience during the previous week. Overall PAQLQ score is equal to the mean of all 23 items for a total possible score 1 (worst) to 7 (best).|Months 2, 6 and 12|"ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. n in the category is the number of participants with data available at the given time-point."||score on a scale||Standard Deviation|Mean
848193|NCT00163293|Secondary|Percentage of Asthma Symptom Free Days|Days without Asthma Symptom documented in the participant's diary were reported.|Months 1, 2, 4, 6, 8, 10 and 12|"ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. n in the category is the number of participants with data available at the given time-point."||percentage of days||Standard Deviation|Mean
848194|NCT00163293|Secondary|Percentage of Rescue Medication Free Days|Days without use of rescue medication documented in the participant’s diary were reported.|Months 1, 2, 4, 6, 8, 10 and 12|"ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. n in the category is the number of participants with data available at the given time-point."||percentage of days||Standard Deviation|Mean
848195|NCT00163293|Secondary|Rescue Medication Use Per Day|Salbutamol (100 μg/puff) was used as rescue medication according to the individual needs of the participant. Each use was documented in the participant’s diary.|Months 1, 2, 4, 6, 8, 10 and 12|"ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. n in the category is the number of participants with data available at the given time-point."||puffs/day||Standard Deviation|Mean
848196|NCT00163293|Secondary|Percentage of Nights With Nocturnal Awakenings Due to Asthma Symptoms|Nocturnal awakenings due to asthma symptoms were recorded in the participant's diary.|Months 1, 2, 4, 6, 8, 10 and 12|"ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. n in the category is the number of participants with data available at the given time-point."||percentage of nights||Standard Deviation|Mean
848197|NCT00163293|Secondary|Total Asthma Symptom Score by Diary Entries|Total Asthma Score = daytime asthma score + night-time asthma score, where higher score indicates worsening of disease. Night-time asthma score is assessed on a 5 point scale where 0=No symptoms, slept through the night, 1=Slept well but some complaints in the morning, 2=Woke up once because of asthma (including early wakening), 3=Woke up several times because of asthma (including early wakening) and 4=Bad night, awake most of the night because of asthma. Day-time asthma score is assessed on a 5 point scale where 0= Very well, no symptoms, 1= One episode of wheezing, cough or breathlessness, 2= More than one episode of wheezing, cough or breathlessness without interfering with normal activities, 3= Wheezing, cough or shortness of breath most of the day which interfered to some extent with normal activities and 4= Asthma very bad. Unable to carry out daily activities as usual.|Months 1, 2, 4, 6, 8, 10 and 12|"ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. n in the category is the number of participants with data available at the given time-point."||score on a scale||Standard Deviation|Mean
848198|NCT00163293|Secondary|Change From Baseline in Diurnal PEF Fluctuation|Diurnal PEF Fluctuation is equal to [(Higher PEF – Lower PEF)/0.5*(Higher PEF + Lower PEF)] * 100%. A positive change from Baseline indicates improvement.|Baseline and Months 1, 2, 4, 6, 8, 10 and 12|"ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. n in the category is the number of participants with data available at the given time-point."||percent fluctuation||Standard Deviation|Mean
848199|NCT00163293|Secondary|Change From Baseline in PEF by Diary Entries|PEF is the maximum speed of expiration. Spirometry was used for assessment of PEF. A positive change from Baseline indicates improvement.|Baseline and Months 1, 2, 4, 6, 8, 10 and 12|"ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. n in the category is the number of participants with data available at the given time-point."||liters/second||Standard Deviation|Mean
848305|NCT00121641|Secondary|Baseline and Change From Baseline at Week 24 in Fasting Plasma Glucose (FPG)||Baseline, Week 24|Randomized participants with measure at given time points, Last Observation Carried Forward (LOCF).||mg/dL||Standard Error|Mean
848200|NCT00163293|Secondary|Morning and Evening Peak Expiratory Flow (PEF) Measurements by Diary Entries|PEF is the maximum speed of expiration. Spirometry was used for assessment of PEF.|Months 1, 2, 4, 6, 8, 10 and 12|"ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. n in the category is the number of participants with data available at the given time-point."||liters/second||Standard Deviation|Mean
848201|NCT00163293|Secondary|Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Percent Predicted)|FEV1 is the maximal amount of air forcefully exhaled from the lungs in one second. Spirometry was used for assessment of FEV1. A positive change from Baseline indicates improvement.|Baseline and Months 1, 2, 4, 6, 8, 10 and 12|"ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. n in the category is the number of participants with data available at the given time-point."||percent predicted FEV1||Standard Deviation|Mean
848202|NCT00163293|Secondary|Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Absolute Value)|FEV1 is the maximal amount of air forcefully exhaled from the lungs in one second. Spirometry was used for assessment of FEV1. A positive change from Baseline indicates improvement.|Baseline and Months 1, 2, 4, 6, 8, 10 and 12|"ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. n in the category is the number of participants with data available at the given time-point."||liters||Standard Deviation|Mean
848203|NCT00163293|Secondary|Percentage of Participants Who Dropped-out Due to Asthma Exacerbation||Up to 12 months|ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome.||percentage of participants|||Number
848204|NCT00163293|Secondary|Number of Exacerbations Per Participant|The mean number of asthma exacerbations per participant is reported.|Up to 12 months|ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome.||exacerbations||Standard Deviation|Mean
848205|NCT00163293|Secondary|Duration of Exacerbations|Duration of exacerbation was defined as the time in days when the criteria for an exacerbation were met to the time when peak flow measurements returned to baseline.|Up to 12 months|ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome.||days||Standard Deviation|Mean
848206|NCT00163293|Secondary|Mean Rate of Asthma Exacerbations Per Year|Rate of asthma exacerbations per year is equal to total number of asthma exacerbations during treatment/time on treatment (year).|Up to 12 months|ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome.||number of exacerbations per year||Standard Deviation|Mean
848207|NCT00163293|Secondary|Growth Velocity as Assessed by Stadiometric Height Measurement|Standing height measured in millimeters (mm) with a wall-mounted stadiometer.|Up to 12 months|Safety analysis set included all randomized participants who received at least 1 dose of trial medication.||mm/year||Standard Deviation|Mean
848208|NCT00163293|Primary|Exacerbations (Post-hoc Analysis of Annual Rates)|A model-based analysis of asthma exacerbation was performed to adjust to important covariables. The distribution of the data suggested a Poisson regression modeling (zero inflated) strategy. After a variable selection process considering also variable-by-treatment interactions, the variables centre, age [years] and race were identified to be important beside treatment. The parameters centre and age [years] were allocated to zero-model part and the variables treatment and race to the Poisson model part. The estimates of the per-treatment rates are based on a negative-binomial distribution.|Up to 12 months|ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome.||number of events per year||Standard Error|Least Squares Mean
848209|NCT00163293|Primary|Time to First Asthma Exacerbation|Time to first asthma exacerbation is defined as the time in days until the first asthma exacerbation, or to the end of treatment visit. In the absence of an exacerbation, an early treatment discontinuation is treated as a censored observation on the day following the last use of study drug.|Up to 12 months|Intention to Treat (ITT) analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome.||days||Standard Error|Mean
848210|NCT00162123|Secondary|Progression-free Survival (PFS)|PFS was defined as the time between the date of the baseline tumor assessment in this study and the date of progression or death, whichever occurred first.|From day of first reinduction in current study to date of progression or death, whichever occurred first.|All participants who received study drug as reinduction from 0.3, 3, or 10 mg/kg doses in parent study and 10 mg/kg in current study||Months||95% Confidence Interval|Median
848211|NCT00162123|Secondary|Number of Participants With On-study Immune-related Adverse Events (irAEs)|irAEs were defined as adverse events characterized by a potential association with inflammation and considered by the investigator as drug related. These prespecified terms were grouped into the following organ-specific subcategories: gastrointestinal, hepatic, skin, endocrine, neurologic, and other (includes blood, eye, immune system, investigations, infections, renal, and respiratory systems). Patients may have 1 or more events.|From first dose of study drug during reinduction to the earliest of 70 days after last dose or day before second reinduction first dose date|All participants who received study drug as reinduction from 0.3, 3, or 10 mg/kg doses in parent study 10 mg/kg current study||Participants|||Number
848212|NCT00162123|Secondary|Percentage of Participants Surviving at 1, 1.5, and 2 Years|Survival rate was defined as the time from first dose of study drug to 1, 1.5, and 2 years.|From first dose of study drug in parent study to up to 2 years after reinduction|All participants who received study drug as reinduction or extended maintenance from 0.3, 3, or 10 mg/kg doses in parent study and 10 mg/kg in current study and those patients who were followed-up.||Percentage of participants|||Number
848213|NCT00162123|Secondary|Overall Survival (OS)|OS was computed for all patients who entered this study and is defined as the time between the first dose of study therapy and death. If a patient has not died, OS was censored at the time of last contact.|From first dose of study drug in parent study to death or date of last censoring.|All participants who received study drug as reinduction from 0.3, 3, or 10 mg/kg doses in parent study and 10 mg/kg in current study||Months||95% Confidence Interval|Median
848214|NCT00162123|Primary|Number of Participants With On-study Adverse Events (AEs), AEs Leading to Discontinuation, Serious Adverse Events (SAEs), Drug-related AEs, Immune-related AEs (irAEs), and Death as Outcome|An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. An SAE is a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related is defined as having certain, probable, possible, or missing relationship to study drug. An IrAE is an AE characterized by a potential association with inflammation and considered by the investigator to be drug related. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.|Continuously from first dose to 70 days after last dose of study drug. For deaths, Day 1 of enrollment to 70 days after last dose of study drug.|All participants who received study drug as reinduction from 0.3, 3, or 10 mg/kg doses in parent study and 10 mg/kg in current study||Participants|||Number
848215|NCT00157014|Secondary|Number of Patients With Treatment Failure and Crossover for Treatment Failure (Pediatric Population)|"Treatment failure was defined as death, re-transplantation, withdrawal due to an Adverse Event, or a switch of main immunosuppressant medication, whichever came first.
Crossover was defined as a switch from originally administered primary immunosuppressant (tacrolimus or cyclosporine) to the alternate primary immunosuppressant."|52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population - defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.||Patients|||Number
848216|NCT00157014|Secondary|Number of Patients With Successful Steroid Taper or Withdrawal at Weeks 26 and 52 (Pediatric Population)|A successful steroid taper or withdrawal was defined as steroids (prednisone) being discontinued or tapered to the suggested dose level after week 26.|26 Weeks and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population - defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.||Patients|||Number
848217|NCT00157014|Secondary|Mean Cases of Acute Rejection (MCAR) Per Patient (Pediatric Population)|"MCAR represents the average number of acute rejections among all patients in each treatment group. Results were based on rejection episodes with endomyocardial biopsies.
Acute rejection was defined as a rejection with ISHLT Grade ≥3A or by the presence of hemodynamic compromise.
ISHLT Grades ≥3A include: Multifocal Moderate Rejection; Diffuse, Borderline Severe Acute Rejection; and Severe Acute Rejection."|52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.||MCAR per patient||Standard Deviation|Mean
848218|NCT00157014|Secondary|Number of Cardiac Rejection Episodes Requiring Treatment (Pediatric Population)|A summary of rejection episodes requiring treatment regardless of biopsy grade or presence of hemodynamic compromise.|52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.||Rejection Episodes|||Number
848219|NCT00157014|Secondary|Number of Patients Requiring Antilymphocyte Antibodies or Steroids for Treatment of Severe Acute Rejection (Pediatric Population)|Severe Acute Rejection was defined as rejection with ISHLT Grade 4.|52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.||Patients|||Number
848220|NCT00157014|Secondary|Time to First Acute Rejection Episode Following de Novo Cardiac Transplant (Pediatric Population)|"Acute Rejection was defined as a rejection with ISHLT Grade ≥3A or by the presence of hemodynamic compromise.
ISHLT Grades ≥3A include: Multifocal Moderate Rejection; Diffuse, Borderline Severe Acute Rejection; and Severe Acute Rejection.
Time to first acute rejection is defined as: date of onset - date of transplant."|52 Weeks|The population analyzed represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation. Only participants who experienced acute rejection were included in the analysis.||Days||Standard Deviation|Mean
848221|NCT00157014|Secondary|Number of Acute Rejection Episodes by International Society of Heart and Lung Transplantation (ISHLT) Criteria (Pediatric Population)|"Acute rejection was defined as a rejection with ISHLT Grade ≥3A or by the presence of hemodynamic compromise.
ISHLT Grades ≥3A include: Multifocal Moderate Rejection; Diffuse, Borderline Severe Acute Rejection; and Severe Acute Rejection.
Patients may report more than one rejection episode."|52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.||Rejection Episodes|||Number
848222|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation and Oxidation: Cystatin-C (Pediatric Population)|Change is defined as Week 52 assessment - Pre-Transplant assessment|Pre-Transplant and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population - defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.||mg/L||Standard Deviation|Mean
848223|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation and Oxidation: hsCRP (Pediatric Population)|Change is defined as Week 52 assessment - Pre-Transplant assessment|Pre-Transplant and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population - defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.||mg/L||Standard Deviation|Mean
848224|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation and Oxidation: Nitrotyrosine (Pediatric Population)|Change is defined as Week 52 assessment - Pre-Transplant assessment|Pre-Transplant and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population - defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.||nM||Standard Deviation|Mean
848225|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation and Oxidation: F2 Isoprostanes (Pediatric Population)|Change is defined as Week 52 assessment - Pre-Transplant assessment|Pre-Transplant and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population - defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.||pg/mL||Standard Deviation|Mean
848226|NCT00157014|Secondary|Number of Patients With Treatment Failure and Crossover for Treatment Failure|"Treatment failure was defined as death, re-transplantation, withdrawal due to an Adverse Event, or a switch of main immunosuppressant medication, whichever came first.
Crossover was defined as a switch from originally administered primary immunosuppressant (tacrolimus or cyclosporine) to the alternate primary immunosuppressant."|52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population - defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.||Patients|||Number
848227|NCT00157014|Secondary|Number of Patients With Successful Steroid Taper or Withdrawal at Weeks 26 and 52|A successful steroid taper or withdrawal was defined as steroids (prednisone) being discontinued or tapered to the suggested dose level after week 26.|26 Weeks and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population - defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.||Patients|||Number
848228|NCT00157014|Secondary|Mean Cases of Acute Rejection (MCAR) Per Patient|"MCAR represents the average number of acute rejections among all patients in each treatment group. Results were based on rejection episodes with endomyocardial biopsies.
Acute rejection was defined as a rejection with ISHLT Grade ≥3A or by the presence of hemodynamic compromise.
ISHLT Grades ≥3A include: Multifocal Moderate Rejection; Diffuse, Borderline Severe Acute Rejection; and Severe Acute Rejection."|52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population - defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.||MCAR per patient||Standard Deviation|Mean
848229|NCT00157014|Secondary|Number of Cardiac Rejection Episodes Requiring Treatment|The number of rejection episodes requiring treatment (medications started/ stopped, non-medication treatment, or both) regardless of biopsy grade or presence of hemodynamic compromise.|52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population - defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.||Rejection Episodes|||Number
848230|NCT00157014|Secondary|Number of Patients Requiring Antilymphocyte Antibodies or Steroids for Treatment of Severe Acute Rejection|Severe Acute Rejection is defined as rejection with ISHLT Grade 4.|52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.||Patients|||Number
848231|NCT00157014|Secondary|Time to First Acute Rejection Episode Following de Novo Cardiac Transplant|"Acute Rejection was defined as a rejection with ISHLT Grade ≥3A or by the presence of hemodynamic compromise.
ISHLT Grades ≥3A include: Multifocal Moderate Rejection; Diffuse, Borderline Severe Acute Rejection; and Severe Acute Rejection.
Time to first acute rejection is defined as: date of onset - date of transplant."|52 Weeks|The population analyzed represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation. Only participants who experienced acute rejection were included in the analysis.||Days||Standard Deviation|Mean
848232|NCT00157014|Secondary|Number of Acute Rejection Episodes by International Society of Heart and Lung Transplantation (ISHLT) Criteria|"Acute rejection was defined as a rejection with ISHLT Grade ≥3A or by the presence of hemodynamic compromise.
ISHLT Grades ≥3A include: Multifocal Moderate Rejection; Diffuse, Borderline Severe Acute Rejection; and Severe Acute Rejection.
Patients may report more than one acute rejection."|52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.||Rejection Episodes|||Number
848233|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Cystatin-C|Change is defined as Week 52 assessment - Pre-Transplant assessment.|Pre-Transplant and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.||mg/L||Standard Deviation|Mean
848234|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: IL-18|Change is defined as Week 52 assessment - Pre-Transplant assessment.|Pre-Transplant and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.||pg/mL||Standard Deviation|Mean
848235|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: IL-6|"Change is defined as Week 52 assessment - Pre-Transplant assessment.
IL= Interleukin"|Pre-Transplant and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.||pg/mL||Standard Deviation|Mean
848236|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Fibrinogen|Change is defined as Week 52 assessment - Pre-Transplant assessment.|Pre-Transplant and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.||g/L||Standard Deviation|Mean
848237|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Osteopontin|Change is defined as Week 52 assessment - Pre-Transplant assessment.|Pre-Transplant and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.||ng/mL||Standard Deviation|Mean
848238|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Troponin T|Change is defined as Week 52 assessment - Pre-Transplant assessment.|Pre-Transplant and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.||ug/L||Standard Deviation|Mean
848239|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: BNP|"Change is defined as Week 52 assessment - Pre-Transplant assessment.
BNP= Brain Natriuretic Peptide"|Pre-Transplant and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.||ng/L||Standard Deviation|Mean
848240|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: GSH/GSSG|"Change is defined as Week 52 assessment - Pre-Transplant assessment.
GSH/GSSG= ratio of reduced to oxidised glutathione"|Pre-Transplant and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.||Ratio||Standard Deviation|Mean
848241|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Nitrotyrosine|Change is defined as Week 52 assessment - Pre-Transplant assessment.|Pre-Transplant and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.||nM||Standard Deviation|Mean
848242|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: T-bars|"Change is defined as Week 52 assessment - Pre-Transplant assessment.
T-bars = thiobarbituric acid reactive substances"|Pre-Transplant and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.||nmol/mL||Standard Deviation|Mean
848243|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: F2 Isoprostanes|Change is defined as Week 52 assessment - Pre-Transplant assessment.|Pre-Transplant and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.||pg/mL||Standard Deviation|Mean
848244|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: hsCRP|"Change is defined as Week 52 assessment - Pre-Transplant assessment.
hsCRP= high-sensitivity C Reactive Protein"|Pre-Transplant and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.||mg/L||Standard Deviation|Mean
848245|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Homocysteine|Change is defined as Week 52 assessment - Pre-Transplant assessment.|Pre-Transplant and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.||μmol/L||Standard Deviation|Mean
848246|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: E-selectin|Change is defined as Week 52 assessment - Pre-Transplant assessment.|Pre-Transplant and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.||ng/mL||Standard Deviation|Mean
848247|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: s-ICAM|"Change is defined as Week 52 assessment - Pre-Transplant assessment.
s-ICAM= soluble-intracellular adhesion molecule"|Pre-Transplant and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.||ng/mL||Standard Deviation|Mean
848248|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: MCP-1|"Change is defined as Week 52 assessment – Pre-Transplant assessment.
MCP-1= monocyte chemoattractant protein-1"|Pre-Transplant and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.||pg/mL||Standard Deviation|Mean
848249|NCT00157014|Primary|The Change in the Markers of Growth, Apoptosis, Inflammation and Oxidation Measured in Endomyocardial Biopsies (Pediatric Population)|"The markers assessed were p-ERK ½, p-JNK and p-p38 MAPK.
The data for each biopsy marker were expressed as a ratio of its densitometry / densitometry of glyceraldehyde-3-phosphate dehydrogenase (GAPDH).
Change is defined as Week 52 assessment- Week 2 assessment."|2 Weeks and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.||Densitometry / Densitometry of GAPDH||Standard Deviation|Mean
848266|NCT00138424|Secondary|Percentage Change of Viral Load in Urine and Plasma BK Virus by Quantitative PCR Between Baseline and Each Visit|The percent change in viral load from baseline to day 7, day 21 and day 49 as measured in the urine and measured in the blood. A drop is identified by use of '-', an increase in viral load has no sign in front of the number.|Baseline, and each visit: day 7, 21, 35 and 49.|||Percent Change||Full Range|Median
848250|NCT00157014|Primary|The Change in the Markers of Growth, Apoptosis, Inflammation and Oxidation Measured in Endomyocardial Biopsies|"The markers assessed were p-ERK ½ (phosphorylated extracellular signal-regulated kinase), p-JNK (phosphorylated jun N-terminal kinase) and p-p38 MAPK (phosphorylated mitogen-activated protein kinase).
The data for each biopsy marker were expressed as a ratio of its densitometry / densitometry of glyceraldehyde-3-phosphate dehydrogenase (GAPDH).
Change is defined as Week 52 assessment- Week 2 assessment."|2 Weeks and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.||Densitometry / Densitometry of GAPDH||Standard Deviation|Mean
848251|NCT00153816|Secondary|Advanced Colorectal Lesions|Includes: adenomas >=1 cm, adenomas with high grade dysplasia, adenomas with villous features, or cancer.|1 to 10 years|Subjects are included if they had a follow-up exam at least one year after randomization and sufficient histology available to ascertain the endpoint.||percentage of subjects||95% Confidence Interval|Number
848252|NCT00153816|Primary|Colorectal Adenomas||1 to 10 years|Subjects are included if they had a follow-up exam at least one year after randomization and had sufficient histology available to ascertain the endpoint.||percentage of subjects||95% Confidence Interval|Number
848253|NCT00138424|Secondary|The Pharmacodynamics of Cidofovir Will be Assessed by Correlating the Percent Change in BK Virus DNA in Urine and Plasma With Pharmacokinetic Changes Between Baseline and Day 35|PK parameter change from baseline to day 35 for AUC4 and AUC12|Baseline through day 35|||hr*mg/L||Full Range|Median
848254|NCT00138424|Secondary|The Pharmacodynamics of Cidofovir Will be Assessed by Correlating the Percent Change in BK Virus DNA in Urine and Plasma With Pharmacokinetic Changes Between Baseline Through Day 35|PK parameter change from baseline to day 35 for Cmax.|Baseline through day 35|||ng/mL||Full Range|Median
848255|NCT00138424|Primary|Number of Subjects Experiencing at Least One Laboratory Abnormality|The following lab values assessed during the 49 days of subject involvement were the following: hemoglobin, hematocrit, platelets, sodium, potassium, chloride, bicarbonate, blood urea nitrogen (BUN), serum creatinine, calcium, phosphorous, serum albumin, glucose, uric acid, magnesium, total protein, total bilirubin, alanine aminotransferase (ALT), asparate aminotransferase (AST) and alkaline phosphate. The outcome measure is the number of subjects experiencing at least 1 grade 1 (mild) or higher event.|Baseline through day 49|||Participants|||Number
848256|NCT00138424|Primary|Changes Observed in the Physical Examination: Heart Rate (Per Minute)|The heart rate is the number of heart beats per minute. The outcome measure is the change from baseline heart rate to day 49 heart rate.|Baseline through day 49.|Subject's whose heart rate was measured at baseline and day 49 visit||Change in Beats per Minute||Full Range|Median
848257|NCT00138424|Primary|Changes Observed in the Physical Examination: Body Temperature (Fahrenheit)|The temperature is a measure of body temperature in fahrenheit (F). The measure is a change between baseline temperature and day 49 temperature.|Baseline through day 49.|Subject's last visit minus baseline visit||Temperature (F)||Full Range|Median
848258|NCT00138424|Secondary|Allograft Rejection.|Allograft rejection is the number of subjects that rejected their kidney by the end of the study.|Day 49.|Number of rejections||Participants|||Number
848259|NCT00138424|Secondary|Allograft Function at the Completion of the Study|"Glomerular filtration rate (GFR) is a test used to check how well the kidneys are working. Specifically, it estimates how much blood passes through the tiny filters in the kidneys, called glomeruli, each minute. The normal health GFR is about 90 - 120 mL/min/1.73 m2. Older people will have lower normal GFR levels, because GFR decreases with age.
Abnormal Results are expected to be below 60 mL/min/1.73 m2 for 3 or more months are a sign of chronic kidney disease. A GFR result below 15 mL/min/1.73 m2 may be a sign of kidney failure."|Day 49.|subjects that had GFR at each visit last visit||mL/min/1.73 m2||Full Range|Median
848260|NCT00138424|Primary|Changes Observed in the Physical Examination: Blood Pressure (mm/hg)|"Blood pressure (BP) is the pressure exerted by circulating blood upon the walls of blood vessels. Blood pressure usually refers to the arterial pressure of the systemic circulation. During each heartbeat, blood pressure varies between a maximum (systolic) and a minimum (diastolic) pressure. The measure is the difference between the baseline systolic and baseline diastolic value with the day 49 systolic and day 49 diastolic value."|Baseline through day 49.|||mm Hg||Full Range|Median
848261|NCT00138424|Primary|Changes Observed in the Physical Examination : Respiratory Rate (Per Minute)|Respiratory rate is the number of breaths per minute.|Baseline through day 49.|subjects whose respiratory rate was measured at baseline visit and at day 49 visit.||Change in Breaths per Minute||Full Range|Median
848262|NCT00138424|Primary|Number of Related Adverse Events|"The investigator’s assessment of an AE's relationship to study drug is part of the documentation process. All adverse events had their relationship to study product assessed using the following terms: associated (related)or not associated (not related). To help assess, the following guidelines were used.
Associated – There was a known temporal relationship and/or, if re-challenge was done, the event abates with de-challenge and reappears with re-challenge and/or the event was known to occur in association study product or with a product in a similar class of study products
Not Associated -the AE was completely independent of study product administration; and/or evidence existed that the event was definitely related to another etiology."|Baseline through day 49.|Number of Related Events||Events|||Number
848263|NCT00138424|Primary|Number of Adverse Events by Grade of Event|"Adverse events are reported as grades:
Toxicity Grade I: a mild event (an event that requires minimal or no treatment and does not interfere with the subject's daily activities.
Toxicity Grade II: a moderate event (an event that results in a low level of inconvenience or concern with the therapeutic measures and may cause some interference with functioning.
Toxicity Grade III: a severe event (an event that interrupts a subject's usual daily activity and may require systemic drug therapy or other treatment and may be incapacitating.
Toxicity Grade IV: Life threatening (any adverse drug experience that places the patient or subject at immediate risk of death from the reaction as it occurred)"|Baseline through day 49.|||Events|||Number
848264|NCT00138424|Secondary|Number of Days to at Least 50% Reduction of Viral Load in Plasma and Urine||Baseline through day 49.|||Days||Full Range|Median
848265|NCT00138424|Secondary|Subjects Achieving 50% Reduction Viral Load in Plasma and Urine||Baseline through day 49.|||Participants|||Number
848267|NCT00138424|Secondary|The Effect of Cidofovir on BK Virus Determined by Percentage of Subjects Achieving an Undetectable BK Virus in Urine and Plasma PCR|The outcome measure is the percent of subjects that achieved non-detectable BK virus in the urine and plasma polymerase chain reaction (PCR) at day 35 after staring study drug. Undetectable is a PCR viral load of less than 200.|Day 35.|Percentage of subjects||percentage of subjects|||Number
848268|NCT00138424|Primary|Safety and Tolerability of Cidofovir Assessed by Enumeration of Adverse Events Per Subject|The measure is the number of adverse events (ie: events that are change from baseline)experienced by subjects. The median or average number of events and the range of events across all subjects is reported.|Baseline through day 49|||Event||Full Range|Median
848269|NCT00121641|Other Pre-specified|Changes From Baseline in Heart Rate During the ST + LT Period - Open Label Cohort||Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167|Treated participants; n=number of treated participants with measurement at time point||beats per minute||Standard Error|Mean
848270|NCT00121641|Other Pre-specified|Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period - Open Label Cohort||Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167|Treated participants; n=number of treated participants with measurement at time point||mmHg||Standard Error|Mean
848271|NCT00121641|Other Pre-specified|Changes From Baseline in Systolic Blood Pressure During the ST + LT Period - Open Label Cohort||Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167|Treated participants; n=number of treated participants with measurement at time point||mmHg||Standard Error|Mean
848272|NCT00121641|Other Pre-specified|Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period - Open Label Cohort|The normality/abnormality of the ECG tracing was determined by the investigator.|Baseline, Weeks 12, 24, 76, 102, 154, 206|Treated participants; BL n=number of participants at baseline||participants|||Number
848273|NCT00121641|Other Pre-specified|Confirmed Hypoglycemia During ST + LT Treatment Period - Open-Label Cohort|'Confirmed' = recorded on the hypoglycemia AE case report form page with a fingerstick glucose <= 50 mg/dL and associated symptoms|AEs: up to last treatment day + 1 day or last visit; SAEs: up to last treatment day + 30 days or last visit + 30 days. Mean duration of exposure was 34 weeks.|Treated participants||participants|||Number
848274|NCT00121641|Other Pre-specified|All Reported Hypoglycemic Adverse Events During ST + LT Treatment Period - Open-Label Cohort|Hypoglycemic Events are based upon the Saxagliptin Predefined List of Events, which included hypoglycemia, blood glucose decreased, and hypoglycemic unconsciousness.|AEs: up to last treatment day + 1 day or last visit; SAEs: up to last treatment day + 30 days or last visit + 30 days. Mean duration of exposure was 34 weeks.|Treated participants||participants|||Number
848275|NCT00121641|Other Pre-specified|Confirmed Hypoglycemia During ST + LT Treatment Period|'Confirmed' = recorded on the hypoglycemia AE case report form page with a fingerstick glucose <= 50 mg/dL and associated symptoms|AEs: up to last treatment day + 1 day or last visit; SAEs: up to last treatment day + 30 days or last visit + 30 days. Mean duration of exposure was 109 weeks in 10 mg arm, 94.7 weeks in 2.5 mg arm, 103 weeks in 5 mg arm, and 98.4 weeks in placebo arm.|Treated participants||participants|||Number
848276|NCT00121641|Other Pre-specified|All Reported Hypoglycemic Adverse Events During ST + LT Treatment Period|Hypoglycemic Events are based upon the Saxagliptin Predefined List of Events, which included hypoglycemia, blood glucose decreased, and hypoglycemic unconsciousness.|AEs: up to last treatment day + 1 day or last visit; SAEs: up to last treatment day + 30 days or last visit + 30 days. Mean duration of exposure was 109 weeks in 10 mg arm, 94.7 weeks in 2.5 mg arm, 103 weeks in 5 mg arm, and 98.4 weeks in placebo arm.|Treated participants||participants|||Number
848277|NCT00121641|Other Pre-specified|Marked Laboratory Abnormalities During ST + LT Treatment Period - Open-Label Cohort|A laboratory value was considered a marked abnormality if it is outside the pre-defined criteria for marked abnormality and the on-treatment value was more extreme (farther from the limit) than the baseline value. Pre-Rx=pretreatment; ULN=upper limit of normal; ALP=alkaline phosphatase; AST=aspartate aminotransferase; ALT=alanine aminotransferase; unspec=unspecified; sodium serum low: <0.9 x Pre-Rx & <=130mEq/L / high: >1.1 x Pre-Rx & >=150mEq/L; potassium, serum low: <=0.8 x Pre-Rx & >=6.0mEq/L / high: 1.2 x Pre-Rx & >=6.0mEq/L; LLN=lower limit of normal.|Lab assessments taken during and up to 14 days after the last dose of study drug during the ST + LT Treatment Period. Mean duration of exposure was 34 weeks.|Number of Participants Analyzed=Treated participants; n=number of treated subjects with baseline value and at least one value during the ST + LT treatment period||participants|||Number
848278|NCT00121641|Other Pre-specified|Overall Summary of Adverse Events During ST+LT Treatment Period - Open-Label Cohort|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Related events=relationship of certain, probable, possible, or missing.|AEs: up to last treatment day + 1 day or last visit; SAEs: up to last treatment day + 30 days or last visit + 30 days. Mean duration of exposure was 34 weeks.|All treated participants||participants|||Number
848279|NCT00121641|Other Pre-specified|Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period|The normality/abnormality of the ECG tracing was determined by the investigator.|Baseline, Weeks 12, 24, 76, 102, 154, 206|Treated participants; BL n=number of participants at baseline||participants|||Number
848280|NCT00121641|Other Pre-specified|Changes From Baseline in Heart Rate During the ST + LT Period||Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point||beats per minute||Standard Error|Mean
848281|NCT00121641|Other Pre-specified|Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period||Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point||mmHg||Standard Error|Mean
848286|NCT00121641|Other Pre-specified|Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point||x 10^3 c/µL||Standard Error|Mean
848287|NCT00121641|Other Pre-specified|Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point||x 10^3 c/µL||Standard Error|Mean
848288|NCT00121641|Other Pre-specified|Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point||x 10^3 c/µL||Standard Error|Mean
848289|NCT00121641|Other Pre-specified|Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point||x 10^9 c/L||Standard Error|Mean
848290|NCT00121641|Other Pre-specified|Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point||x 10^6 c/µL||Standard Error|Mean
848291|NCT00121641|Other Pre-specified|Baseline and Changes From Baseline in Hematocrit During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point||percentage red blood cells||Standard Error|Mean
848292|NCT00121641|Other Pre-specified|Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point||g/dL||Standard Error|Mean
848293|NCT00121641|Other Pre-specified|Marked Laboratory Abnormalities - During ST + LT Treatment Period|A laboratory value was considered a marked abnormality if it is outside the pre-defined criteria for marked abnormality and the on-treatment value was more extreme (farther from the limit) than the baseline value. Pre-Rx=pretreatment; ULN=upper limit of normal; ALP=alkaline phosphatase; AST=aspartate aminotransferase; ALT=alanine aminotransferase; unspec=unspecified; sodium serum low: <0.9 x Pre-Rx & <=130mEq/L / high: >1.1 x Pre-Rx & >=150mEq/L; potassium, serum low: <=0.8 x Pre-Rx & >=6.0mEq/L / high: 1.2 x Pre-Rx & >=6.0mEq/L; LLN=lower limit of normal.|Lab assessments taken during and up to 14 days after the last dose of study drug during the ST + LT Treatment Period. Mean duration of exposure was 109 weeks in 10 mg arm, 94.7 weeks in 2.5 mg arm, 103 weeks in 5 mg arm, and 98.4 weeks in placebo arm.|Number of Participants Analyzed=Treated participants; n=number of treated subjects with baseline value and at least one value during the ST + LT treatment period||participants|||Number
848294|NCT00121641|Other Pre-specified|Overall Summary of Adverse Events During ST+LT Treatment Period|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Related events=relationship of certain, probable, possible, or missing.|AEs: up to last treatment day + 1 day or last visit; SAEs: up to last treatment day + 30 days or last visit + 30 days. Mean duration of exposure was 109 weeks in 10 mg arm, 94.7 weeks in 2.5 mg arm, 103 weeks in 5 mg arm, and 98.4 weeks in placebo arm.|All treated participants||participants|||Number
848295|NCT00121641|Other Pre-specified|Baseline Demographic Characteristic (Body Mass Index) - Summary for ST + LT Treatment Period - Open-Label Cohort|This cohort represents a different population (screening A1C > 10.0% and ≤ 12.0%) than the double-blind cohort, and was presented separately in the study report.|Baseline|||kg/m^2||Standard Deviation|Mean
848296|NCT00121641|Other Pre-specified|Baseline Demographic Characteristic (Weight) - Summary for ST + LT Treatment Period - Open-Label Cohort|This cohort represents a different population (screening A1C > 10.0% and ≤ 12.0%) than the double-blind cohort, and was presented separately in the study report.|Baseline|||kg||Standard Deviation|Mean
848297|NCT00121641|Other Pre-specified|Baseline Demographic Characteristics - Summary for ST + LT Treatment Period - Open-Label Cohort|This cohort represents a different population (screening A1C > 10.0% and ≤ 12.0%) than the double-blind cohort, and was presented separately in the study report.|Baseline|||participants|||Number
848298|NCT00121641|Other Pre-specified|Baseline Demographic Characteristic (Age, Continuous) - Summary for ST + LT Treatment Period - Open-Label Cohort|This cohort represents a different population (screening A1C > 10.0% and ≤ 12.0%) than the double-blind cohort, and was presented separately in the study report.|Baseline|||years||Standard Deviation|Mean
848299|NCT00121641|Secondary|Baseline and Change From Baseline at Week 24 in Postprandial Glucose (PPG) Area Under the Curve (AUC) - Open Label Cohort||Baseline, Week 24|Open Label participants with measure at given time points, Last Observation Carried Forward (LOCF).||mg*min/dL||Standard Error|Mean
848300|NCT00121641|Primary|A1C Changes From Baseline at Week 24 - Open Label Cohort|To compare the change from baseline in HbA1c achieved with each dose of saxagliptin versus placebo in treatment naive subjects with type 2 diabetes who have inadequate glycemic control defined as A1C ≥7.0% and ≤10.0%.|Baseline, Week 24|Open-label participants with both a baseline and a post-baseline (up to Week 24)||Percentage of glycosylated hemoglobins||Standard Error|Mean
848301|NCT00121641|Secondary|Percentage of Participants Achieving Therapeutic Glycemic Response (A1C < 7.0%) at Week 24 - Open Label Cohort||Week 24|Open Label Participants with measurement at time point, Last Observation Carried Forward (LOCF)||percentage of participants|||Number
848302|NCT00121641|Secondary|Baseline and Change From Baseline at Week 24 in Fasting Plasma Glucose (FPG) - Open Label Cohort||Baseline, Week 24|Open Label Subjects with Measurement at Timepoint; Last Observation Carried Forward (LOCF)||mg/dL||Standard Error|Mean
848306|NCT00121641|Primary|Hemoglobin A1c (A1C) Changes From Baseline at Week 24|To compare the change from baseline in HbA1c achieved with each dose of saxagliptin versus placebo in treatment naive subjects with type 2 diabetes who have inadequate glycemic control defined as A1C ≥7.0% and ≤10.0%.|Baseline, Week 24|Randomized participants with both a baseline and post-baseline value (up to Week 24).||Percentage of glycosylated hemoglobins||Standard Error|Mean
848307|NCT00121667|Other Pre-specified|Confirmed Hypoglycemia During the ST + LT Treatment Period|'Confirmed' = recorded on the hypoglycemia AE case report form with a fingerstick glucose <= 50 mg/dL and associated symptoms.|AEs: up to last treatment day + 1 day or last visit day in the ST+LT period; SAEs: up to last treatment day + 30 days or last visit day + 30 days in the LT+ST period. Mean duration of exposure: 124, 118, 130, 95 wks respectively for 2.5mg, 5mg, 10 mg, pla|Treated participants||participants|||Number
848308|NCT00121667|Other Pre-specified|All Reported Hypoglycemic Adverse Events During the ST + LT Treatment Period|Hypoglycemic Events are based upon the Saxagliptin Predefined List of Events, which are hypoglycemia, blood glucose decreased, and hypoglycemic unconsciousness.|AEs: up to last treatment day + 1 day or last visit day in the ST+LT period; SAEs: up to last treatment day + 30 days or last visit day + 30 days in the LT+ST period. Mean duration of exposure: 124, 118, 130, 95 wks respectively for 2.5mg, 5mg, 10 mg, pla|Treated participants||participants|||Number
848309|NCT00121667|Other Pre-specified|Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period|The normality/abnormality of the ECG tracing was determined by the investigator.|Baseline, Weeks 12, 24, 76, 102, 154, 206,|Number of Participants Analyzed=Treated Participants; BL n=normal or abnormal ECG status at baseline of the cohort of participants with measure at given time point||participants|||Number
848310|NCT00121667|Other Pre-specified|Changes From Baseline in Heart Rate During the ST + LT Period||Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point||beats/min||Standard Error|Mean
848311|NCT00121667|Other Pre-specified|Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period||Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point||mmHg||Standard Error|Mean
848312|NCT00121667|Other Pre-specified|Changes From Baseline in Systolic Blood Pressure During the ST + LT Period||Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point||mmHg||Standard Error|Mean
848313|NCT00121667|Other Pre-specified|Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point||10^3 c/µL||Standard Error|Mean
848314|NCT00121667|Other Pre-specified|Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point||10^3 c/µL||Standard Error|Mean
848315|NCT00121667|Other Pre-specified|Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point||10^3 c/µL||Standard Error|Mean
848316|NCT00121667|Other Pre-specified|Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point||10^3 c/µL||Standard Error|Mean
848317|NCT00121667|Other Pre-specified|Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point||10^3 c/µL||Standard Error|Mean
848318|NCT00121667|Other Pre-specified|Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point||10^3 c/µL||Standard Error|Mean
848319|NCT00121667|Other Pre-specified|Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point||10^9 c/L||Standard Error|Mean
848320|NCT00121667|Other Pre-specified|Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point||10^6 c/µL||Standard Error|Mean
848321|NCT00121667|Other Pre-specified|Baseline and Changes From Baseline in Hematocrit During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point||percentage red blood cells||Standard Error|Mean
848322|NCT00121667|Other Pre-specified|Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point||g/dL||Standard Error|Mean
848347|NCT00114777|Secondary|Mean Framingham Risk Score From Baseline to Months 12, 24 and 36|The risk score was calculated based on the total points from six variables: Age, Level of LDL-cholesterol, Level of HDL-cholesterol, Presence and severity of systolic or diastolic hypertension, Presence or absence of a history of diabetes mellitus and Presence or absence of a history recent cigarette smoking. Total scores can range from <-3 to >14, which translate to a 1% to 56% risk of developing coronary heart disease in 10 years. Totals in the 4 to 6 point range translate to a 7 to 11% risk and 8 to 10 point range translate to a 18 to 27% risk.|Baseline and Months 12, 24 and 36|All randomized and transplanted participants||units on a scale||Standard Deviation|Mean
848323|NCT00121667|Other Pre-specified|Marked Laboratory Abnormalities - During ST + LT Treatment Period|A laboratory value was considered a marked abnormality if it is outside the pre-defined criteria for marked abnormality and the on-treatment value was more extreme (farther from the limit) than the baseline value. Pre-Rx=pretreatment; ULN=upper limit of normal; ALP=alkaline phosphatase; AST=aspartate aminotransferase; ALT=alanine aminotransferase; unspec=unspecified; sodium serum low: <0.9 x Pre-Rx & <=130mEq/L / high: >1.1 x Pre-Rx & >=150mEq/L; potassium, serum low: <=0.8 x Pre-Rx & >=6.0mEq/L / high: 1.2 x Pre-Rx & >=6.0mEq/L; LLN=lower limit of normal.|Lab assessments taken during and up to 14 days after the last dose of study drug during the ST + LT Treatment Period. Mean duration of exposure: 124, 118, 130, 95 weeks, respectively, for 2.5mg, 5mg, 10 mg, placebo.|Number of Participants Analyzed=Treated participants; n=number of treated subjects with baseline value and at least one value during the ST + LT treatment period||participants|||Number
848324|NCT00121667|Other Pre-specified|Overall Summary of Adverse Events During ST+LT Treatment Period|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Related events=relationship of certain, probable, possible, or missing.|AEs: up to last treatment day + 1 day or last visit day in the ST+LT period; SAEs: up to last treatment day + 30 days or last visit day + 30 days in the LT+ST period. Mean duration of exposure: 124, 118, 130, 95 wks respectively for 2.5mg, 5mg, 10 mg, pla|All treated participants||participants|||Number
848325|NCT00121667|Secondary|Baseline and Change From Baseline at Week 24 in Postprandial Glucose (PPG) Area Under the Curve (AUC)|Mean change from baseline is adjusted for baseline value.|Baseline, Week 24|Randomized Participants with measurement at timepoint. Last Observation Carried Forward (LOCF).||mg*min/dL||Standard Error|Mean
848326|NCT00121667|Secondary|Percentage of Participants Achieving Therapeutic Glycemic Response (A1C < 7.0%) at Week 24||Week 24|Randomized Participants with measurement at time point, Last Observation Carried Forward (LOCF)||percentage of participants|||Number
848327|NCT00121667|Secondary|Baseline and Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Mean change from baseline is adjusted for baseline value.|Baseline, Week 24|Randomized Participants with measurement at timepoint. Last Observation Carried Forward (LOCF).||mg/dL||Standard Error|Mean
848328|NCT00121667|Primary|Baseline and Change From Baseline in Hemoglobin A1c (A1C) at Week 24|Mean change from baseline is adjusted for baseline value.|Baseline, Week 24|Randomized participants with both a baseline and post-baseline value (up to Week 24)||percentage of glycosylated hemoglobins||Standard Error|Mean
848329|NCT00117598|Other Pre-specified|Time to Tumor Progression (TTP)|TTP: time from randomization to first documentation of objective tumor progression (including recurrence); censored at last valid tumor assessment.|Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)|ITT||months||95% Confidence Interval|Median
848330|NCT00117598|Other Pre-specified|Time to Failure (TTF)|TTF is defined as the time from randomization to the date of the first documentation of Progressive Disease (PD), the date of treatment discontinuation except completion of treatment, or date of death (any cause).|Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)|ITT||months||95% Confidence Interval|Median
848331|NCT00117598|Other Pre-specified|Duration of Response|Time from the first documentation of objective tumor response to first date that recurrence or progressive disease (PD) was objectively documented; censored at last valid tumor assessment.|Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)|ITT subset of participants who had a response||months||95% Confidence Interval|Median
848332|NCT00117598|Other Pre-specified|Time to Response|Time between the date of randomization and the first date of objective response for participants with a confirmed objective response.|Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)|ITT subset of participants with a confirmed objective response||months||95% Confidence Interval|Median
848333|NCT00117598|Other Pre-specified|Overall Survival (OS)|Overall survival is the duration from randomization to death. For participants who are alive, overall survival is censored at the last contact.|Baseline up to 5 years|ITT||months||95% Confidence Interval|Median
848334|NCT00117598|Secondary|Percentage of Participants With Objective Response|Assessment of complete or partial response (CR, PR) or uncomplete response (CRu) using Response Evaluation Criteria in Solid Tumors. CR: 1) No disease evident. 2) Lymph node, nodal mass regressed to normal size. 3) Previously enlarged organ ↓ size. 4) Bone marrow clear on repeat aspirate, biopsy. CRu: CR 1 and 3, at least 1 of following: Lymph node regressed >75%. Bone marrow ↑ number or aggregate size, no cytologic/architectural atypia. PR: ≥50% ↓ index lesion, no size ↑ in other nodes, liver, spleen. Splenic and hepatic nodule regressed ≥50%. No new disease.|Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)|ITT||percentage of participants||95% Confidence Interval|Number
848335|NCT00117598|Primary|Progression-Free Survival (PFS)|The period from randomization until disease progression, death or date of last contact.|Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)|Intent-to-Treat (ITT) Population: All randomized participants at time of primary analysis||months||95% Confidence Interval|Median
848336|NCT00114777|Secondary|Percentage of Participants With Graft Loss or Death to Month 84|Participant and graft survival at 84 months was summarized within each treatment group.|Randomization to date of death, up to 84 months|All randomized and transplanted participants||percentage of participants|||Number
848348|NCT00114777|Secondary|Systolic and Diastolic Blood Pressure (BP) at 12, 24 and 36 Months|Participants were determined to have hypertension at a particular time point if standardized systolic blood pressure ≥ 130 mm Hg or standardized diastolic blood pressure ≥ 80 mm Hg or participant had received an anti-hypertensive medication(s) for hypertension. Here 'n' signifies those participants evaluable for this measure at specified time points for each arm, respectively.|Months 12, 24 and 36|All randomized and transplanted participants||mmHg||Standard Deviation|Mean
848337|NCT00114777|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 84|AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.|Day 1 to Month 84|All randomized and transplanted participants who completed 36 months of treatment and continued into long-term extension phase||participants|||Number
848338|NCT00114777|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 36|AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.|Day 1 to Month 36|All randomized and transplanted participants||participants|||Number
848339|NCT00114777|Secondary|Number of Participants With Laboratory Test Abnormalities up to 36 Months|Participants with laboratory values outside the defined normal range were graded as clinically significant laboratory abnormalities by the investigator. Subjects were analyzed for Alkaline phosphatase (ALP), Alanine aminotransferase (ALT), Aspartate aminotransferase(AST), Hemoglobin, Platelet Count, Leukocytes, Bilirubin, Creatinine, Calcium, Bicarbonate, Potassium, Magnesium, Sodium, Phosphorus, Albumin, Uric Acid and Protein. Laboratory abnormalities were assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3. Here 'n' signifies those subjects evaluable for this measure at specified time points for each arm, respectively.|Day 1 to Month 36|All randomized and transplanted participants.||participants|||Number
848340|NCT00114777|Secondary|Number of Participants With Clinically Significant Changes in Vital Signs up to 36 Months|Participants with abnormal blood pressure, body weight and body temperature outside the defined normal range were graded as clinically significant vital signs by the investigator.|Day 1 to Month 36|All randomized and transplanted participants||participants|||Number
848341|NCT00114777|Secondary|Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36|The SF-36 is a 36-item self-administered questionnaire developed to assess health-related quality of life (QOL) and comprises 8 domains, including 4 physical (physical health, bodily pain, physical functioning and physical role limitations) and 4 mental (mental health, vitality, social functioning, and emotional role limitation) subscales. Responses are used to derive physical and mental component summary scores, ranging from 0 to 100, with higher scores indicating better QOL (0=Poorest Health; 100=Best Health). Mean change from baseline = post-baseline value - baseline value; a higher value signifies improvement.|Baseline and Months 12, 24 and 36|Randomized and transplanted participants||units on SF-36 scale||Standard Error|Mean
848342|NCT00114777|Secondary|Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84|Acute rejection was defined as central biopsy proven rejection that was either clinically suspected by protocol defined reasons or clinically suspected by other reasons and treated. Clinically suspected acute rejection was defined as an unexplained rise of serum creatinine ≥ 25% from baseline creatinine or an unexplained decreased urine output or fever and graft tenderness or serum creatinine that remains elevated within 14 days post­-transplantation and clinical suspicion of acute rejection exists.|Months 6, 12, 24, 36 and 84|All randomized and transplanted participants||participants|||Number
848343|NCT00114777|Secondary|Number of Participants Using Lymphocyte Depleting Therapy and Steroid-Resistant for Acute Rejection by Months 6, 12, 24, and 36.|Acute rejection was defined as central biopsy proven rejection that was either clinically suspected by protocol defined reasons or clinically suspected by other reasons and treated. Lymphocyte ­depletion therapy for treatment of an episode of acute was defined as a participant treated with therapy and provided not treated with steroids earlier while steroid resistant acute rejection was defined as participants initially treated with steroids alone for suspected acute rejection for at least 2 days and then followed by the start of lymphocyte ­depletion therapy.|Months 6, 12, 24 and 36|All randomized and transplanted participants||participants|||Number
848344|NCT00114777|Secondary|Percentage of Participants Who Have an Acute Rejection by Months 6, 12, 24, 36 and 84|Acute rejection was defined as central biopsy proven rejection that was either clinically suspected by protocol defined reasons or clinically suspected by other reasons and treated. Clinically suspected acute rejection was defined as an unexplained rise of serum creatinine ≥ 25% from baseline creatinine or an unexplained decreased urine output or fever and graft tenderness or serum creatinine that remains elevated within 14 days post­-transplantation and clinical suspicion of acute rejection exists.|Months 6, 12, 24, 36 and 84|All randomized and transplanted participants||percentage of participants||95% Confidence Interval|Number
848345|NCT00114777|Secondary|Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36|Dyslipidemia was defined as triglyceride ≥ 500 mg/dL [5.65 mmol/L], low density lipoprotein (LDL) ≥ 100 mg/dL [2.59 mmol/L], and elevated non-high density lipoprotein (HDL) ≥ 130 mg/dL [3.36 mmol/L]. Here 'n' signifies those participants evaluable for this measure at specified time points for each arm, respectively.|Months 12, 24 and 36|All randomized and transplanted participants||mg/dL||Standard Deviation|Mean
848346|NCT00114777|Secondary|Percentage of Participants Using Lipid-Lowering Therapy at 12, 24, and 36 Months|Dyslipidemia was defined as triglyceride ≥ 500 mg/dL [5.65 mmol/L], low density lipoprotein (LDL) ≥ 100 mg/dL [2.59 mmol/L], and non-elevated high density lipoprotein (HDL) ≥ 130 mg/dL [3.36 mmol/L]. Here 'n' signifies those participants evaluable for this measure at specified time points for each arm, respectively.|Months 12, 24 and 36|All randomized and transplanted participants||percentage of participants||95% Confidence Interval|Number
848364|NCT00073073|Secondary|Effect of This Drug on Breast Tissue Trefoil Factor 1 and Proliferating Cell Nuclear Antigen Expression, Prolactin, and Breast Tissue Prolactin Receptor at 1 Year||1 year|Change in breast tissue trefoil factor 1||percent change from baseline||95% Confidence Interval|Mean
848349|NCT00114777|Secondary|Percentage of Participants With New Onset Diabetes Mellitus (NODM) at 12, 24 and 36 Months.|NODM was defined as participant who did not have diabetes prior to randomization. Participants were determined for NODM if the participant received an antidiabetic medication for a duration of at least 30 days, or at least two fasting plasma glucose (FPG) tests indicate that FPG is ≥ 126 mg/dL (7.0 mmol/L).|Months 12, 24 and 36|All randomized and transplanted participants||percentage of participants||95% Confidence Interval|Number
848350|NCT00114777|Secondary|Percentage of Subjects Who Used Anti-Hypertensive Medications to Control Hypertension at Months 12, 24 and 36|Participants were determined to have hypertension at a particular time point if standardized systolic blood pressure ≥ 130 mm Hg or standardized diastolic blood pressure ≥ 80 mm Hg or subject had received an anti-hypertensive medication(s) for hypertension. Here 'n' signifies those participants evaluable for this measure at specified time points for each arm, respectively.|Months 12, 24 and 36|All randomized and transplanted participants||percentage of participants||95% Confidence Interval|Number
848351|NCT00114777|Secondary|Number of Participants With Anti-Hypertensive Medications Used to Control Hypertension at 12, 24 and 36 Months|Participants were determined to have hypertension at a particular time point if standardized systolic blood pressure ≥ 130 mm Hg or standardized diastolic blood pressure ≥ 80 mm Hg or participant had received an antihypertensive medication(s) for hypertension. Here 'n' signifies those participants evaluable for this measure at specified time points for each arm, respectively.|Baseline and Months 12, 24 and 36|All randomized and transplanted participants||participants|||Number
848352|NCT00114777|Secondary|Change in Calculated GFR at Months 12, 24, 36 and 84|GFR was assessed using a true measure of glomerular filtration via nonradiolabeled iothalamate clearance test using a validated procedure. Missing measured GFR assessments were imputed. Here 'n' signifies those participants evaluable for this measure at specified time points for each arm, respectively.|Baseline and Months 12, 24, 36 and 84|All randomized and transplanted participants||mL/min/1.73 m^2||Standard Deviation|Mean
848353|NCT00114777|Secondary|Calculated Glomerular Filtration Rate (GFR) at 6, 12, 24, 36 and 84 Months|GFR was assessed using a true measure of glomerular filtration via nonradiolabeled iothalamate clearance test using a validated procedure. Missing measured GFR assessments were imputed. Here 'n' signifies those participants evaluable for this measure at specified time points for each arm, respectively.|Months 6, 12, 24, 36 and 84|All randomized and transplanted participants||participants||Standard Deviation|Mean
848354|NCT00114777|Secondary|Percentage of Participants Who Survived With a Graft at 24 and 36 Months Post-Transplant|Participant and graft survival at 12 months was summarized within each treatment group. Graft loss was defined as either functional loss or physical loss (nephrectomy). Functional loss will be defined as a sustained level of serum creatinine ≥ 6.0 mg/dL (530 μmol/L) as determined by central laboratory for ≥ 4 weeks or 56 or more consecutive days of dialysis.|Month 24 and Month 36 post-transplant|All randomized and transplanted participants||percentage of participants||95% Confidence Interval|Number
848355|NCT00114777|Secondary|Percentage of Participants With Chronic Allograft Nephropathy (CAN) at Month 12|Biopsy-proven CAN was determined by a blinded central histopathologist using the Banff 97 working classification of kidney transplant pathology. Onset of CAN was determined by the biopsy date when it was observed. Participants were considered as having CAN at 12 months if: CAN observed in a biopsy either prior to 12 months (including baseline biopsy) or first post 12 months biopsy; Participant had graft loss during the first year post transplant; no biopsy available post 12 months and CAN not observed in biopsies prior to 12 months; no biopsy available either prior to or post 12 months; and the measured glomerular filtration rate from Month 3 to Month 12 decreases at least 10 mL/min/1.73m^2. All other participants with missing 12 month biopsy were considered having no CAN observed at 12 months.|At Month 12|All randomized and transplanted participants||percentage of participants||95% Confidence Interval|Number
848356|NCT00114777|Secondary|Measured Glomerular Filtration Rate (GFR) by Month 12 and 24|GFR was assessed using a true measure of glomerular filtration via nonradiolabeled iothalamate clearance test using a validated procedure. Missing measured GFR assessments were imputed. Here, ‘n’ signifies the number of evaluable participants for the reporting arm at the given time point. Missing measured GFR assessments were imputed to a GFR of zero.|At Month 12 and Month 24|All randomized and transplanted participants||mL/min/1.73 m^2||Standard Deviation|Mean
848357|NCT00114777|Primary|Percentage of Participants With a Measured Glomerular Filtration Rate (GFR) <60 mL/Min Per 1.73 m^2 at Month 12 or a Decrease in Measured GFR >=10 mL/Min Per 1.73 m^2 From Month 3 to Month 12|GFR was assessed using a true measure of glomerular filtration via non-radiolabeled iothalamate clearance test using a validated procedure.|From Month 3 to Month 12|All randomized and transplanted participants||percentage of participants||95% Confidence Interval|Number
848358|NCT00114777|Primary|Percentage of Participants Who Survived With a Graft at 12 Months Post-Transplant|Participant and graft survival at 12 months was summarized within each treatment group. Graft loss was defined as either functional loss or physical loss (nephrectomy). Functional loss was defined as a sustained level of serum creatinine ≥ 6.0 mg/dL (530 μmol/L) as determined by central laboratory for ≥4 weeks or 56 or more consecutive days of dialysis.|Month 12 post-transplant|All randomized and transplanted participants||percentage of participants||95% Confidence Interval|Number
848359|NCT00100230|Other Pre-specified|Loss of Peripheral Visual Fields|Hypothesis: Elevation of red blood cell-docosahexaenoic acid levels will slow the progressive loss of peripheral visual fields in this 4-year trial.|4 years|Only participants completing at least one year of trial||decibels (dB)||Standard Error|Mean
848360|NCT00100230|Secondary|Rate of LOSS of Rod Electroretinographic Function|Hypothesis #1: Elevation of red blood cell-docosahexaenoic acid levels will slow the progressive loss of rod electroretinographic response in this 4-year trial.|4 years|Number of participants completing at least one year of trial (i.e., modified intent to treat cohort)||change in amplitude, log microvolts/year||Standard Error|Mean
848361|NCT00100230|Primary|Rate of LOSS of 31 Hertz Cone Electroretinographic Function|Hypothesis #1: Elevation of red blood cell-docosahexaenoic acid levels will slow the progressive loss of 31 hertz cone electroretinographic response in this 4-year trial.|4 years|Number of participants completing at least one year of trial (i.e., modified intent to treat cohort)||log microvolts/year||Standard Error|Mean
848362|NCT00073073|Secondary|Number of Serum and Breast Tissue Samples Collected for Exploratory Proteomic Profiles at One Year||1 year|Outcome not measured|||||
848363|NCT00073073|Secondary|Effect of Exemestane on Autocrine Prolactin and Breast Tissue Prolactin Receptor at One Year||1 year|Outcome not measured|||||
848371|NCT00051363|Secondary|Quality of Life: Calgary Sleep Apnea Quality of Life Index- Total Score (SAQLI-TS)|Quality of life was measured using the Calgary Sleep Apnea Quality of Life Index (SAQLI), which is an interview-administered instrument with high internal consistency and reliability. The SAQLI was designed to assess components identified as important to patients including daily functioning, social interactions, emotional functioning, symptoms experienced, and treatment-related symptoms. Items are scored on a seven-point scale, averaged (taking into account treatment-related symptoms), to yield a composite score between 1 and 7, where higher scores represent better quality of life.|diagnostic visit (baseline)|Analyses performed for group of participants with SAQLI data. Baseline demographics were generally similar (mean age, sex ratio, proportion of white participants, average body mass index), and participants in both groups had similar SAQLI scores at baseline, which are presented below.||Units on a scale||Standard Deviation|Mean
848372|NCT00051363|Secondary|Mood||Measured at diagnostic visit (baseline) and 2 months and 6 months post intervention|Mood was dropped as a secondary outcome measure for analysis by our Core Team.|||||
848373|NCT00051363|Secondary|Subjective Sleepiness/Alertness: Epworth Sleepiness Scale- Total Score (ESS-TS)|"Subjective sleepiness/alertness was measured using the Epworth Sleepiness Scale (ESS); the outcome variable was ESS Total Score (ESS-TS).
The ESS is a validated questionnaire (8 questions) that ask the chances of dozing off in specific situations. Summing the scores produces a scaled total score between 0 and 24, with higher numbers indicating more subjective sleepiness. The ESS was administered the evening before the polysomnogram (PSG), or overnight sleep study. Data reported here include questionnaires collected at the DX, 2M, and 6M visits."|Measured at diagnostic visit (baseline) and 2 months and 6 months post intervention|Analyses conducted in accordance with the intention-to-treat principle. Analyses performed by OSA severity level categorized by apnea hypopnea index (AHI: # of respiratory events/hr of sleep) obtained via baseline polysomnography. Categories are: Mild OSA (AHI = 10-14.9; exclusion if AHI <10), Moderate OSA (AHI = 15-29.9), Severe OSA (AHI >=30).||scores on a scale||Standard Deviation|Mean
848374|NCT00051363|Secondary|Objective Sleepiness/Alertness: Maintenance of Wakefulness Test- Mean Sleep Latency (MWT-MSL)|"Objective sleepiness/alertness was measured using the Maintenance of Wakefulness Test (MWT); the outcome variable was MWT Mean Sleep Latency (MWT-MSL).
The MWT was administered using four twenty-minute trials where the participant was asked to sit in a chair, in a quiet and dimly lit room, with instructions to stay awake. Trials were performed at 10 AM, Noon, 2 PM and 4 PM. The mean sleep latency was calculated using the 4 trials from a given visit, and required that at least 3 of the 4 trials were performed and validated."|Measured at diagnostic visit (baseline) and 2 months and 6 months post intervention|Analyses conducted in accordance with the intention-to-treat principle. Analyses performed by OSA severity level categorized by apnea hypopnea index (AHI: # of respiratory events/hr of sleep) obtained via baseline polysomnography. Categories are: Mild OSA (AHI = 10-14.9; exclusion if AHI <10), Moderate OSA (AHI = 15-29.9), Severe OSA (AHI >=30).||minutes||Standard Deviation|Mean
848375|NCT00051363|Secondary|Executive and Frontal-Lobe (E/F) Function: Shifting Attention Test Discovery Condition- Number of Rule Changes (SAT-D-NumRuCh)|"The APPLES a priori Secondary Neurocognitive Analysis Plan specified a dimension reduction method to reduce twelve secondary neurocognitive variables from three neurocognitive domains to seven variables from three neurocognitive domains. Three of the selected variables came from the domain of Executive and Frontal-Lobe (E/F) Function: Sustained Working Memory Test- Mid-day Behavioral Index (SWMT-BehMD), SWMT- Mid-day Activation Index (SWMT-ActMD), and Shifting Attention Test Discovery Condition- Number of Rule Changes (SAT-D-NumRuCh).
These data are for variable #3: Shifting Attention Test Discovery Condition- Number of Rule Changes (SAT-D-NumRuCh)"|2 months and 6 months post intervention|Analyses conducted in accordance with the intention-to-treat principle. Analyses performed by OSA severity level categorized by apnea hypopnea index (AHI: # of respiratory events/hr of sleep) obtained via baseline polysomnography. Categories are: Mild OSA (AHI = 10-14.9; exclusion if AHI <10), Moderate OSA (AHI = 15-29.9), Severe OSA (AHI >=30).||number of rule changes (dichotomized)||95% Confidence Interval|Mean
848376|NCT00051363|Secondary|Executive and Frontal-Lobe (E/F) Function: SWMT- Mid-day Activation Index (SWMT-ActMD)|"The APPLES a priori Secondary Neurocognitive Analysis Plan specified a dimension reduction method to reduce twelve secondary neurocognitive variables from three neurocognitive domains to seven variables from three neurocognitive domains. Three of the selected variables came from the domain of Executive and Frontal-Lobe (E/F) Function: SWMT-BehMD, SWMT-ActMD, and SAT-D-NumRuCh.
These data are for variable #2: SWMT- Mid-day Activation Index (SWMT-ActMD)
SWMT-ActMD is a scaled score that indicates whether the participant scored lower or higher relative to baseline (BL) using standard deviation units. It is computed as the difference from BL relative to EEG power spectral variables (decibels) measured during the easier vs. more difficult working memory (WM) tasks. A positive activation sub-score indicates a larger cortical neuronal population was recruited to perform the more difficult WM task relative to BL, while a negative score indicates a smaller population was recruited."|2 months and 6 months post intervention|Analyses conducted in accordance with the intention-to-treat principle. Analyses performed by OSA severity level categorized by apnea hypopnea index (AHI: # of respiratory events/hr of sleep) obtained via baseline polysomnography. Categories are: Mild OSA (AHI = 10-14.9; exclusion if AHI <10), Moderate OSA (AHI = 15-29.9), Severe OSA (AHI >=30).||score on a scale||95% Confidence Interval|Mean
848377|NCT00051363|Secondary|Executive and Frontal-Lobe (E/F) Function: Sustained Working Memory Test- Mid-day Behavioral Index (SWMT-BehMD)|"The APPLES a priori Secondary Neurocognitive Analysis Plan specified a dimension reduction method to reduce twelve secondary neurocognitive variables from three neurocognitive domains to seven variables from three neurocognitive domains. Three of the selected variables came from the domain of Executive and Frontal-Lobe (E/F) Function: SWMT-BehMD, SWMT-ActMD, and SAT-D-NumRuCh.
These data are for variable #1: Sustained Working Memory Test- Mid-day Behavioral Index (SWMT-BehMD)
SWMT-BehMD is a scaled score that indicates whether the participant scored lower or higher relative to baseline using standard deviation units. It is computed as the difference from baseline relative to measures of working memory (WM) task performance accuracy (percent correct) and mean and standard deviation of reaction time (milliseconds). High-load WM tasks receive twice the weight of the low-load WM tasks."|2 months and 6 months post intervention|Analyses conducted in accordance with the intention-to-treat principle. Analyses performed by OSA severity level categorized by apnea hypopnea index (AHI: # of respiratory events/hr of sleep) obtained via baseline polysomnography. Categories are: Mild OSA (AHI = 10-14.9; exclusion if AHI <10), Moderate OSA (AHI = 15-29.9), Severe OSA (AHI >=30).||score on a scale||95% Confidence Interval|Mean
848378|NCT00051363|Secondary|Learning and Memory (L/M) Function: Buschke Selective Reminding Test Delayed Recall- Total Recall (BSRTDR-TotRec)|The APPLES a priori Secondary Neurocognitive Analysis Plan specified a dimension reduction method to reduce twelve secondary neurocognitive variables from three neurocognitive domains to seven variables from three neurocognitive domains. One of the selected variables came from the domain of Learning and Memory (L/M) Function: Buschke Selective Reminding Test Delayed Recall- Total Recall (BSRTDR-TotRec).|2 months and 6 months post intervention|Analyses conducted in accordance with the intention-to-treat principle. Analyses performed by OSA severity level categorized by apnea hypopnea index (AHI: # of respiratory events/hr of sleep) obtained via baseline polysomnography. Categories are: Mild OSA (AHI = 10-14.9; exclusion if AHI <10), Moderate OSA (AHI = 15-29.9), Severe OSA (AHI >=30).||number of words recalled||95% Confidence Interval|Mean
848379|NCT00051363|Secondary|Attention and Psychomotor (A/P) Function: PVT- Mean Slowest 10% of Reaction Times (PVT-Slo10%RT)|"The APPLES a priori Secondary Neurocognitive Analysis Plan specified a dimension reduction method to reduce twelve secondary neurocognitive variables from three neurocognitive domains to seven variables from three neurocognitive domains. Three of the selected variables came from the domain of Attention and Psychomotor (A/P) Function: Pathfinder Number- Reaction Time (PN-RT), Psychomotor Vigilance Task- Median Reaction Time (PVT-MedRT), and PVT- Mean Slowest 10% of Reaction Times (PVT-Slo10%RT).
These data are for variable #3: PVT- Mean Slowest 10% of Reaction Times (PVT-Slo10%RT)"|2 months and 6 months post intervention|Analyses conducted in accordance with the intention-to-treat principle. Analyses performed by OSA severity level categorized by apnea hypopnea index (AHI: # of respiratory events/hr of sleep) obtained via baseline polysomnography. Categories are: Mild OSA (AHI = 10-14.9; exclusion if AHI <10), Moderate OSA (AHI = 15-29.9), Severe OSA (AHI >=30).||milliseconds||95% Confidence Interval|Mean
848380|NCT00051363|Secondary|Attention and Psychomotor (A/P) Function: Psychomotor Vigilance Task- Median Reaction Time (PVT-MedRT)|"The APPLES a priori Secondary Neurocognitive Analysis Plan specified a dimension reduction method to reduce twelve secondary neurocognitive variables from three neurocognitive domains to seven variables from three neurocognitive domains. Three of the selected variables came from the domain of Attention and Psychomotor (A/P) Function: Pathfinder Number- Reaction Time (PN-RT), Psychomotor Vigilance Task- Median Reaction Time (PVT-MedRT), and PVT- Mean Slowest 10% of Reaction Times (PVT-Slo10%RT).
These data are for variable #2: Psychomotor Vigilance Task- Median Reaction Time (PVT-MedRT)"|2 months and 6 months post intervention|Analyses conducted in accordance with the intention-to-treat principle. Analyses performed by OSA severity level categorized by apnea hypopnea index (AHI: # of respiratory events/hr of sleep) obtained via baseline polysomnography. Categories are: Mild OSA (AHI = 10-14.9; exclusion if AHI <10), Moderate OSA (AHI = 15-29.9), Severe OSA (AHI >=30).||milliseconds||95% Confidence Interval|Mean
848381|NCT00051363|Secondary|Attention and Psychomotor (A/P) Function: Pathfinder Number- Reaction Time (PN-RT)|"The APPLES a priori Secondary Neurocognitive Analysis Plan specified a dimension reduction method to reduce twelve secondary neurocognitive variables from three neurocognitive domains to seven variables from three neurocognitive domains. Three of the selected variables came from the domain of Attention and Psychomotor (A/P) Function: Pathfinder Number- Reaction Time (PN-RT), Psychomotor Vigilance Task- Median Reaction Time (PVT-MedRT), and PVT- Mean Slowest 10% of Reaction Times (PVT-Slo10%RT).
These data are for variable #1: Pathfinder Number- Reaction Time (PN-RT)"|2 months and 6 months post intervention|Analyses conducted in accordance with the intention-to-treat principle. Analyses performed by OSA severity level categorized by apnea hypopnea index (AHI: # of respiratory events/hr of sleep) obtained via baseline polysomnography. Categories are: Mild OSA (AHI = 10-14.9; exclusion if AHI <10), Moderate OSA (AHI = 15-29.9), Severe OSA (AHI >=30).||seconds||95% Confidence Interval|Mean
848382|NCT00051363|Primary|Effect of CPAP on Neurocognitive Function: L/M Function- BSRT-SR|"There are three primary measures of neurocognitive function measured for APPLES, each representing a different domain: Executive and Frontal-lobe (E/F) Function- Sustained Working Memory Test Overall Mid-Day Index (SWMT-OMD), Attention and Psychomotor (A/P) Function- Pathfinder Number Test Total Time (PFN-TOTL), and Learning and Memory (L/M) Function- Buschke Selective Reminding Test Sum Recall (BSRT-SR).
This is domain #3: Learning and Memory (L/M) Function- Buschke Selective Reminding Test Sum Recall (BSRT-SR)"|Measured at diagnostic visit (baseline) and 2 months and 6 months post intervention|Analyses conducted in accordance with the intention-to-treat principle.||number of words recalled||95% Confidence Interval|Mean
848383|NCT00051363|Primary|Effect of CPAP on Neurocognitive Function: A/P Function- PFN-TOTL|"There are three primary measures of neurocognitive function measured for APPLES, each representing a different domain: Executive and Frontal-lobe (E/F) Function- Sustained Working Memory Test Overall Mid-Day Index (SWMT-OMD), Attention and Psychomotor (A/P) Function- Pathfinder Number Test Total Time (PFN-TOTL), and Learning and Memory (L/M) Function- Buschke Selective Reminding Test Sum Recall (BSRT-SR).
This is domain #2: Attention and Psychomotor (A/P) Function- Pathfinder Number Test Total Time (PFN-TOTL)"|Measured at diagnostic visit (baseline) and 2 months and 6 months post intervention|Analyses conducted in accordance with the intention-to-treat principle.||seconds||95% Confidence Interval|Mean
848384|NCT00051363|Primary|Effect of CPAP on Neurocognitive Function: E/F Function- SWMT-OMD|"There are three primary measures of neurocognitive function measured for APPLES, each representing a different domain: Executive and Frontal-lobe (E/F) Function- Sustained Working Memory Test Overall Mid-Day Index (SWMT-OMD), Attention and Psychomotor (A/P) Function- Pathfinder Number Test Total Time (PFN-TOTL), and Learning and Memory (L/M) Function- Buschke Selective Reminding Test Sum Recall (BSRT-SR).
This is domain #1: Executive and Frontal-lobe (E/F) Function- Sustained Working Memory Test Overall Mid-Day Index (SWMT-OMD)
SWMT-OMD is a scaled score that indicates whether the participant scored lower or higher relative to baseline using standard deviation units. It is computed as the mean of three sub-scores, one based on working memory (WM) task performance (behavioral WM sub-score: speed, accuracy), and the other two on electroencephalogram (EEG) (cortical activation sub-score: neural workload, attentional effort during WM task; alertness sub-score: resting alertness)."|2 months and 6 months post intervention|Analyses conducted in accordance with the intention-to-treat principle.||score on a scale||95% Confidence Interval|Mean
848385|NCT00044213|Secondary|A Composite of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke.|Number of patients with events (composite of cardiovascular death, non-fatal MI, non-fatal stroke) Events were centrally adjudicated where available; otherwise site reported events were used.|Measured over a maximum 5-year follow-up period- 55 month median|||participants|||Number
848386|NCT00044213|Primary|A Composite of Total Mortality, Recurrent Myocardial Infarction, Stroke, Coronary Revascularization, and Hospitalization for Angina.|Number of patients with events (composite of death from any cause, MI, stroke, coronary revascularization or hospitalization for angina) Events were centrally adjudicated where available; otherwise site reported events were used.|Measured over a maximum 5-year follow-up period- 55 month median|||participants|||Number
848387|NCT00031486|Secondary|Survival With no or Mild Neuropsychological Impairment at 90 Days and at 6 and 12 Months, as Measured by the Glasgow Coma Scale (GCS).|The assessment scoring for the Glasgow Coma Scale is as follows: 15: no neuropsychological impairment; 12 - 14: mild neuropsychological impairment; 9 - 11: moderate neuropsychological impairment; 6 to 8: severe neuropsychological impairment; and <6: very severe neuropsychological impairment.|90 days, 6 and 12 months|All subjects that survived and were assessed at 90 days, 6 and 12 months.||Participants|||Number
848388|NCT00031486|Secondary|Survival With no or Mild Neuropsychological Impairment at 90 Days, and at 6 and 12 Months, as Measured by the Mini-Mental Status Examination (MMSE).|The assessment score for the Mini-Mental Status Examination is as follows: 27 - 30: no neuropsychological impairment; 23 - 26: mild neuropsychological impairment; 16 - 22: moderate neuropsychological impairment; 11 - 15 severe neuropsychological impairment; and <=10: very severe neuropsychological impairment.|90 days, 6 and 12 months|All subjects that survived and were assessed at 90 days, 6 and 12 months.||Participants|||Number
848389|NCT00031486|Secondary|Survival With no or Mild Neuropsychological Impairment at 90 Days and at 6 and 12 Months, as Measured by the Mattis Dementia Rating Scale (MDRS)|The assessment scoring for the Mattis Dementia Rating Scale is as follows: 139 - 144: no neuropsychological impairment; 121- 138: mild neuropsychological impairment; 114 - 120: moderate neuropsychological impairment; 87 - 113: severe neuropsychological impairment; and <=86: very severe neuropsychological impairment.|90 days, 6 and 12 months|All subjects that survived and were assessed at 90 days, 6 and 12 months.||Participants|||Number
848390|NCT00031486|Secondary|Median Number of Reported AEs Describing Safety and Tolerance of Valacyclovir (VACV), Evaluated by the Number Adverse Events, Administered at a Dose of 2.0 Grams Given Orally 3 Times a Day for 90 Days.|The measure is the number of adverse events per subject. Adverse events were recorded from time of first dose of study drug through 6 months post start of study drug.|6 months|||Events per participants||Full Range|Median
848391|NCT00031486|Secondary|Effect of Antiviral Therapy on Herpes Simplex Virus (HSV) Deoxyribonucleic Acid (DNA) in Cerebral Spinal Fluid (CSF)|Few CSF specimens were collected on day 90, hence unable to calculate the difference in PCR at day 0 and day 90.[measured quantitatively by polymerase chain reaction (PCR)].|Day 0 and Day 90.|The number of participants analyzed is 0 because there specimens obtained were inadequate and insufficient to analyze.||viral load|||Number
848392|NCT00031486|Secondary|Effect of Study Medication on Quality of Life Measurements.|The SF-36 Questionnaire measures quality of life as reported by the subject. The questionnaire contains 36 questions, each questions can be assigned a maximum score of 100. For each subject, a perfect score would be 3600, hence the higher score is best. The calculated scores reported in the table below reflect the diffence between Day 0 (day study drug started) and Day 90, Day 0 (day study drug started) and Month 6, and Day 0 (day study drug started) and Month 12.|Day 0 and 90, Day 0 and Month 6 and Day 0 and Month 12|All subjects that were assessed at baseline and the following time points: 90 days, 6 and 12 months.||Scores on a scale Change in SF-36||Full Range|Median
848393|NCT00031486|Primary|Survival With no or Mild Neuropsychological Impairment at 12 Months After Initiation of Study Medication as Measured by the Mattis Dementia Rating Scale (MDRS)|Number of subjects who were assessed to have no or mild neuropsychological impairment at 12 months using the Mattis Dementia Rating Scale. (A score of 121 or higher refects no or mild neuropsychological impairment.) Scale is: 139-144 normal; 121-139 mild; 114-120 moderate; 87-113 severe; and <=86 very severe.|One year post therapy.|All subjects that survived to 12 months and were assessed.||Participants|||Number
848394|NCT02943213|Secondary|Apparent Terminal Elimination Half-life (t1/2) - 7-Hydroxy-Chlorpromazine|Time Frame = sampling times|0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hours|All subjects who completed the PK blood sampling for this study and for whom primary PK parameters were calculated for both treatment periods were included in the statistical PK analysis of the study.||hr||Geometric Coefficient of Variation|Geometric Mean
848395|NCT02943213|Secondary|Apparent Terminal Elimination Half-life (t1/2) - Chlorpromazine|Time Frame = sampling times|0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hours|All subjects who completed the PK blood sampling for this study and for whom primary PK parameters were calculated for both treatment periods were included in the statistical PK analysis of the study.||hr||Geometric Coefficient of Variation|Geometric Mean
848396|NCT02943213|Secondary|Terminal Elimination Rate Constant (λz) - 7-Hydroxy-Chlorpromazine|Time Frame = sampling times|0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hours|All subjects who completed the PK blood sampling for this study and for whom primary PK parameters were calculated for both treatment periods were included in the statistical PK analysis of the study.||1/hr||Geometric Coefficient of Variation|Geometric Mean
848397|NCT02943213|Secondary|Terminal Elimination Rate Constant (λz) - Chlorpromazine|Time Frame = sampling times|0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hours|All subjects who completed the PK blood sampling for this study and for whom primary PK parameters were calculated for both treatment periods were included in the statistical PK analysis of the study.||1/hr||Geometric Coefficient of Variation|Geometric Mean
848398|NCT02943213|Secondary|Time to Maximum Observed Plasma Concentration (Tmax) - 7-Hydroxy-Chlorpromazine|Time Frame = sampling times|0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hours|All subjects who completed the PK blood sampling for this study and for whom primary PK parameters were calculated for both treatment periods were included in the statistical PK analysis of the study.||hr||Full Range|Median
848399|NCT02943213|Secondary|Time to Maximum Observed Plasma Concentration (Tmax) - Chlorpromazine|Time Frame = sampling times|0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hours|All subjects who completed the PK blood sampling for this study and for whom primary PK parameters were calculated for both treatment periods were included in the statistical PK analysis of the study.||hr||Full Range|Median
848400|NCT02943213|Primary|Area Under the Plasma Concentration Versus Time Curve, With Extrapolation to Infinity (AUC(0-∞)) - 7-Hydroxy-Chlorpromazine|Time Frame = sampling times.|0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hours|All subjects who completed the PK blood sampling for this study and for whom primary PK parameters were calculated for both treatment periods were included in the statistical PK analysis of the study.||h*pg/mL||Geometric Coefficient of Variation|Geometric Mean
848401|NCT02943213|Primary|Area Under the Plasma Concentration Versus Time Curve, With Extrapolation to Infinity (AUC(0-∞)) - Chlorpromazine|Time Frame = sampling times.|0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hours|All subjects who completed the PK blood sampling for this study and for whom primary PK parameters were calculated for both treatment periods were included in the statistical PK analysis of the study.||h*pg/mL||Geometric Coefficient of Variation|Geometric Mean
848402|NCT02943213|Primary|Area Under the Plasma Concentration Versus Time Curve, From Time Zero to t, Where t is the Time of the Last Quantifiable Concentration (AUC(0-t)) - 7-Hydroxy-Chlorpromazine|Time Frame = sampling times.|0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hours|All subjects who completed the PK blood sampling for this study and for whom primary PK parameters were calculated for both treatment periods were included in the statistical PK analysis of the study.||h*pg/mL||Geometric Coefficient of Variation|Geometric Mean
848403|NCT02943213|Primary|Area Under the Plasma Concentration Versus Time Curve, From Time Zero to t, Where t is the Time of the Last Quantifiable Concentration (AUC(0-t)) - Chlorpromazine|Time Frame = sampling times.|0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hours|All subjects who completed the PK blood sampling for this study and for whom primary PK parameters were calculated for both treatment periods were included in the statistical PK analysis of the study.||h*pg/mL||Geometric Coefficient of Variation|Geometric Mean
848404|NCT02943213|Primary|Maximum Observed Plasma Concentration (Cmax) - 7-Hydroxy-Chlorpromazine|Time Frame = sampling times.|0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hours|All subjects who completed the PK blood sampling for this study and for whom primary PK parameters were calculated for both treatment periods were included in the statistical PK analysis of the study.||pg/mL||Geometric Coefficient of Variation|Geometric Mean
848405|NCT02943213|Primary|Maximum Observed Plasma Concentration (Cmax) - Chlorpromazine|Time Frame = sampling times.|0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hours|All subjects who completed the PK blood sampling for this study and for whom primary PK parameters were calculated for both treatment periods were included in the statistical PK analysis of the study.||pg/mL||Geometric Coefficient of Variation|Geometric Mean
848406|NCT02907268|Primary|Blinded Assessment: Overall Change in Facial Wrinkles From Baseline to Week 16 as Assessed by a Numeric Rating Scale Based on Pre- and Post-treatment Photographs|Blinded assessments of overall change in facial wrinkles from baseline to week 16 based on pre and post treatment photographs. Measured on a 5 point scale which is a static assessment of wrinkle severity. 0=wrinkles absent (minimum), 1=shallow but visible wrinkles, 2=fine lines slight indentation, 3=clear indentation 0-1mm deep, 4=moderate indentation 1-2mm deep, 5=deep indentation >2mm deep (maximum). A higher value = a worse outcome (more severe wrinkles). Includes 9 subscales measured on the same scale described above. Subscales measure wrinkle severity in the left and right forehead region, left and right cheek region, left and right crow's feet region, left and right upper lip region, and glabellar region. All scores were computed by averaging subscale ratings.|Baseline and 16 weeks|||units on a scale||Standard Deviation|Mean
848407|NCT02907268|Primary|Blinded Assessment: Overall Change in Facial Wrinkles From Baseline to Week 4 as Assessed by a Numeric Rating Scale Based on Pre- and Post-treatment Photographs|Blinded assessments of overall change in facial wrinkles from baseline to week 4 based on pre and post treatment photographs. Measured on a 5 point scale which is a static assessment of wrinkle severity. 0=wrinkles absent (minimum), 1=shallow but visible wrinkles, 2=fine lines slight indentation, 3=clear indentation 0-1mm deep, 4=moderate indentation 1-2mm deep, 5=deep indentation >2mm deep (maximum). A higher value = a worse outcome (more severe wrinkles). Includes 9 subscales measured on the same scale described above. Subscales measure wrinkle severity in the left and right forehead region, left and right cheek region, left and right crow's feet region, left and right upper lip region, and glabellar region. All scores were computed by averaging subscale ratings.|Baseline and 4 weeks|||units on a scale||Standard Deviation|Mean
848408|NCT02907268|Primary|Blinded Assessment: Overall Change in Facial Wrinkles From Baseline to Week 2 as Assessed by a Numeric Rating Scale Based on Pre- and Post-treatment Photographs|Blinded assessments of overall change in facial wrinkles from baseline to week 2 based on pre and post treatment photographs. Measured on a 5 point scale which is a static assessment of wrinkle severity. 0=wrinkles absent (minimum), 1=shallow but visible wrinkles, 2=fine lines slight indentation, 3=clear indentation 0-1mm deep, 4=moderate indentation 1-2mm deep, 5=deep indentation >2mm deep (maximum). A higher value = a worse outcome (more severe wrinkles). Includes 9 subscales measured on the same scale described above. Subscales measure wrinkle severity in the left and right forehead region, left and right cheek region, left and right crow's feet region, left and right upper lip region, and glabellar region. All scores were computed by averaging subscale ratings.|Baseline and 2 weeks|||units on a scale||Standard Deviation|Mean
848409|NCT02787564|Secondary|Amount of Fruits and Vegetables Among Non-Food Bank Users|The difference of fruit and vegetable amount consumed between baseline and after the 4-week intervention among non-food bank users.|8 weeks|||portions/day||Standard Deviation|Mean
848410|NCT02787564|Secondary|Variety of Fruits and Vegetables Among Non-Food Bank Users|The difference of fruit and vegetable variety consumed between baseline and after the 4-week intervention among non-food bank users.|8 weeks|||types/day||Standard Deviation|Mean
848411|NCT02787564|Secondary|Amount of Fruits and Vegetables Among Food Bank Users|The difference of fruit and vegetable amount consumed between baseline and after the 4-week intervention among food bank users.|8 weeks|||portions/day||Standard Deviation|Mean
848412|NCT02787564|Secondary|Variety of Fruits and Vegetables Among Food Bank Users|The difference of fruit and vegetable variety consumed between baseline and after the 4-week intervention among food bank users.|8 weeks|||types/day||Standard Deviation|Mean
848413|NCT02787564|Primary|Amount of Fruits and Vegetables|The difference of fruit and vegetable amount consumed between baseline and after the 4-week intervention.|8 weeks|||portions/day||Standard Deviation|Mean
848414|NCT02787564|Primary|Variety of Fruits and Vegetables|The difference of fruit and vegetable variety consumed between baseline and after the 4-week intervention.|8 weeks|||types/day||Standard Deviation|Mean
848415|NCT02751320|Secondary|Enamel Fluoride Uptake (EFU) of All Study Formulation Variables|The microdrill enamel biopsy technique was used to analyze the fluoride uptake by enamel. Each enamel specimen was mounted on the long axis of a drill attached to a microdrill and drilled to a depth of approximately 100 μm through the entire lesion (four cores per specimen). The enamel powder pooled from four drilling samples was then immediately analyzed for fluoride content using fluoride specific electrode and pH/ion meter. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores and expressed as μg/cm^2.|At Week 4|ITT population, all participants who were randomized, received the study products at least once and provided at least one post-baseline assessment of efficacy. Number of participants who missed enamel specimens were: Test product1-[1], Test product2-[2], Test product3-[3], Reference Product1-[1], Reference Product2-[1] and Reference Product3-[1].||μg/cm^2||Standard Deviation|Mean
848416|NCT02751320|Secondary|Enamel Fluoride Uptake (EFU) of All Study Formulation Variables|The microdrill enamel biopsy technique was used to analyze the fluoride uptake by enamel. Each enamel specimen was mounted on the long axis of a drill attached to a microdrill and drilled to a depth of approximately 100 μm through the entire lesion (four cores per specimen). The enamel powder pooled from four drilling samples was then immediately analyzed for fluoride content using fluoride specific electrode and pH/ion meter. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores and expressed as μg/cm^2.|At Week 2|ITT population, all participants who were randomized, received the study products at least once and provided at least one post-baseline assessment of efficacy. Number of participants who missed enamel specimens were: Test product1-[1], Test product2-[1], Test product3-[2], Reference Product1-[1], Reference Product2-[1] and Reference Product3-[1].||μg/cm^2||Standard Deviation|Mean
848417|NCT02751320|Secondary|TMR Δm Value of 0.85% Phytate Compared to 0% Phytate, in the Presence of 1150ppm F and 0.3% ZnCl2, 0.3% ZnCl2 Compared to 0% ZnCl2 in the Presence of 1150ppm F and 0.3% ZnCl2 Compared to 0% ZnCl2 in the Presence of 1150ppm F and 0.85% Phytate|TMR was used to assess changes in the mineral status of partially demineralized enamel specimens. Lesions were analyzed at baseline and Integrated Mineral Loss (∆Z): (∆Z =(lesion depth x 87) - area under the curve [Area under the curve which relates volume % mineral at distances from the specimen surface with respect to section thickness]). After treatment a further section was taken from each lesion specimen for radiography assessment; ∆Z was calculated. The change which occurred in mineral content (∆M) of the lesions as a result of treatment was calculated by: ∆M= (baseline ∆Z - Post-treatment ∆Z).|Baseline upto 4 weeks|ITT population, all participants who were randomized, received the study products at least once and provided at least one post-baseline assessment of efficacy. Number of participants who missed enamel specimens were: Test product 2 - [1], Test product 3 - [2], Reference Product 2 - [1] and Reference Product 3 [1].||[%vol mineral x µm||Standard Deviation|Mean
848418|NCT02751320|Secondary|Transverse Microradiography (TMR) Net Remineralization Change (ΔM) Value of Phytate (0% 0.452% and 0.85%) at 4 Weeks|TMR was used to assess changes in the mineral status of partially demineralized enamel specimens. Lesions were analyzed at baseline and Integrated Mineral Loss (∆Z): (∆Z =(lesion depth x 87) - area under the curve [Area under the curve which relates volume % mineral at distances from the specimen surface with respect to section thickness]). After treatment a further section was taken from each lesion specimen for radiography assessment; ∆Z was calculated. The change which occurred in mineral content (∆M) of the lesions as a result of treatment was calculated by: ∆M= (baseline ∆Z - Post-treatment ∆Z).|Baseline upto 4 weeks|ITT population, all participants who were randomized, received the study products at least once and provided at least one post-baseline assessment of efficacy. Number of participants who missed enamel specimens were: Test product 1- [1], Test product 2- [1], and Reference Product 2- [1].||[%vol mineral x µm||Standard Deviation|Mean
848419|NCT02751320|Secondary|% SMHR of 0.85% Phytate Compared to 0% Phytate, in Presence of 1150ppm Fluoride and 0.3% ZnCl2, 0.3% ZnCl2 Compared to 0% ZnCl2 in the Presence of 1150ppm Fluoride and 0.3% ZnCl2 Compared to 0% ZnCl2 in the Presence of 1150ppm Fluoride and 0.85% Phytate|SMHR test was used to assess the changes in mineralization status of partially demineralized enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. % SMHR was calculated from indentation length (μm) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization(D), indentation length (μm) after intra-oral exposure (R): [D-R/D-B]*100.|Baseline upto 2 weeks|ITT population, all participants who were randomized, received the study products at least once and provided at least one post-baseline assessment of efficacy. Number of participants who missed enamel specimens were: Test product 2- [1], Test product 3- [2], Reference Product 2- [1], and Reference Product 3- [1].||% SMHR||Standard Deviation|Mean
848420|NCT02751320|Primary|Percentage Surface Microhardness Recovery (SMHR) of Phyte (0% 0.425% and 0.85%) at 2 Weeks|SMHR test was used to assess the changes in mineralization status of partially demineralized enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. % SMHR was calculated from indentation length (micrometer [μm]) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization(D), indentation length (μm) after intra-oral exposure (R): [D-R/D-B]*100.|Baseline upto 2 weeks|Intent-to-treat (ITT) population, all participants who were randomized, received the study products at least once and provided at least one post-baseline assessment of efficacy. Number of participants who missed enamel specimens were: Test product 1- [1], Test product 2- [1], Reference Product 1- [1], and Reference Product 2- [1].||% SMHR||Standard Deviation|Mean
848421|NCT02730351|Secondary|Weighted Mean 0-60 Min for Percentage Decrease From Pre-exercise FEV1 Following Exercise Challenge at 12 Hrs and 23 Hrs Post Evening Dose.|The exercise challenge testing at the end of 2 week treatment period was performed on a treadmill at 12 hrs and 23 hrs after administration of the evening dose of double-blind treatment. Following exercise challenge testing, post-exercise FEV1 values were assessed serially at 5, 10, 15, 30, 45 and 60 min. Pre-exercise FEV1 was defined as the FEV1 value collected prior to the exercise challenge test at 23 hrs post-dose. Number of participants listed is the number in the ITT population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|At Week 2 of treatment period 1 and 2|ITT Population. Participants with non-missing covariates and data specific to endpoint were analyzed||Percentage of FEV1||Standard Error|Least Squares Mean
848422|NCT02730351|Secondary|Proportion of Participants With a 30 Min Post-challenge FEV1 no More Than 5 Percent Lower Than Pre-exercise FEV1 Following the Exercise Challenge at 12 Hrs and 23 Hrs Post Evening Dose.|The blinded treatment exercise challenge test was performed at the end of 2-weeks of treatment period 1 and treatment period 2 on a treadmill at 12 hrs and 23 hrs after administration of the evening dose of study treatment. The challenge was followed immediately by serial assessments of FEV1 at 5, 10, 15, 30, 45 and 60 min post-exercise. Pre-exercise FEV1 was defined as the FEV1 value collected prior to the exercise challenge test at 23 hrs post-dose. Number of participants listed is the number in the ITT population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|At Week 2 of treatment period 1 and 2|ITT Population. Participants with non-missing covariates and data specific to endpoint were analyzed||Participants|||Number
848423|NCT02730351|Secondary|Maximal Percent Decrease in FEV1 Following Exercise Challenge at 23 Hrs Post Evening Dose From Pre-exercise FEV1.|The exercise challenge test is a stepped challenge on a treadmill. It was performed at 23 hrs post evening dose at the end of the 2-week treatment period, wherein the participants exercised sufficiently to reach a heart rate between 80 to 95 percent of their predicted maximum within 4 min and maintained the heart rate with exercise for an additional 6 min followed immediately by serial assessments of FEV1 at 5, 10, 15, 30, 45 and 60 min post-exercise. Maximal percent decrease was calculated as pre-exercise FEV1 minus minimum post exercise FEV1 (smallest FEV1 value collected within one hr following exercise challenge) divided by pre-exercise FEV1 multiplied by 100. Pre-exercise FEV1 was defined as the FEV1 collected prior to the exercise challenge test at 23 hr post dose.|At Week 2 of treatment period 1 and 2|ITT Population. Participants with non-missing covariates and data specific to endpoint were analyzed||Percentage of FEV1||Standard Error|Least Squares Mean
848424|NCT02730351|Primary|Maximal Percent Decrease in Forced Expiratory Volume in One Second (FEV1) Following Exercise Challenge at 12 Hours (Hrs) Post Evening Dose From Pre-exercise FEV1.|The exercise challenge test is a stepped challenge on a treadmill. It was performed at 12 hrs post evening dose at the end of the 2-week treatment period, wherein the participants exercised sufficiently to reach a heart rate between 80 to 95 percent of their predicted maximum within 4 minutes (min) and maintained the heart rate with exercise for an additional 6 min followed immediately by serial assessments of FEV1 at 5, 10, 15, 30, 45 and 60 min post-exercise. Maximal percent decrease was calculated as pre-exercise FEV1 minus minimum post exercise FEV1 (smallest FEV1 value collected within one hr following exercise challenge) divided by pre-exercise FEV1 multiplied by 100. Pre-exercise FEV1 was defined as the FEV1 collected prior to the exercise challenge test at 12 hr post dose. ITT Population comprised of all participants randomized to treatment and who received at least one dose of study medication.|At Week 2 of treatment period 1 and 2|ITT Population. Participants with non-missing covariates and data specific to endpoint were analyzed||Percentage of FEV1||Standard Error|Least Squares Mean
848425|NCT02724111|Secondary|Adverse Events : The Postoperative Nausea and Vomiting Occurrence in Subject|The occurrence of any adverse events was recorded in the post-anesthesia care unit (PACU) and a ward during the postoperative 24 hours.|during the postoperative 24 hours|||Participants|||Count of Participants
848426|NCT02724111|Secondary|Recovery Time (Time to Reach Sedation Score 5 at Postanesthesia Care Unit (PACU).|the time to reach sedation score 5 (the Observer's Assessment of Alertness/ Sedation (OAA/S) score; awake, 5 to unresponsive, 1) at PACU|every 10 min for 1 hour at PACU.|||minute||Standard Deviation|Mean
848427|NCT02724111|Secondary|The Degree of Bleeding|2.The degree of bleeding of each patient scaled by surgeons (Intraoperative scale for assessment of operating condition of surgical field: 0 - No bleeding, 1 - Slight bleeding - no suctioning of blood required, 2 - Slight bleeding - occasional suctioning required but not threatened the operative field, 3 ‑ Slight‑bleeding - frequent suctioning of blood was required that threatens the operative field a few seconds after suctioning, 4 - Moderate bleeding - frequent suctioning of blood was required which threatens the operative field directly after suctioning, 5 - Severe bleeding - continuous suctioning of blood was required which severely threatened the operative field make the surgery not possible).|Continuously observed during the whole period of surgery, up to 3 hours|||Scores on a scale (NRS; 0-5)||Standard Deviation|Mean
848428|NCT02724111|Secondary|The Number of Body Movements|The number of body movements (including cough or any diaphragm movement) observed during the surgery.|At the occurrence of the event during surgery, up to 3 hours|||number of event||Standard Deviation|Mean
848429|NCT02724111|Secondary|The Muscle Tone|The muscle tone of each patient at the screw insertion through the pedicle of spine during surgery scaled by surgeons (1: muscle tone is good, suitable for surgery; 2: muscle tone is moderate, but do not affect the operation; 3: muscle tone is hard, making the operation difficult.).|at the screw insertion through the pedicle of spine during surgery|||Scores on a scale (NRS; 1-3)||Standard Deviation|Mean
848430|NCT02724111|Secondary|Overall Satisfaction of Surgeons for the Surgical Condition|Overall satisfaction of surgeons for the surgical condition will be assessed by the surgeons who perform surgery using numerical rating scale (NRS; 1-10) after surgery (1, worst; 10, best).|After surgery|||Scores on a scale (NRS; 1-10)||Standard Deviation|Mean
848431|NCT02724111|Secondary|Mean Value of Pressure of Back Muscle Retractor|Mean value of pressure of back muscle retractor placed in the operating site (recorded every 15 minutes during the placement of the retractor): measured by the pressure probe placed between the retractor and the back muscle.|Every 15 minutes at the period of the retractor placement during surgery, up to 2 hours﻿|||mmHg||Standard Deviation|Mean
848432|NCT02724111|Primary|Mean Value of Peak Inspiratory Pressure|This outcome is the mean value of the peak inspiratory pressure measured at each 15 minute during the anesthesia, which can reflect the degree of the tone of respiratory muscles. As muscle tone increases, airway pressure usually increases due to increased tone of abdominal muscle and respiratory muscles including diaphragm. The longer the surgery goes, the higher the airway pressure gets. Also, as neurospinal surgeries are operated in the prone position, the potential for increased airway pressure is high. As airway pressure gets higher, intrathoracic pressure and intraabdominal pressure also become higher. These consequences may bring about similar results with detrimental effects derived from marked increase in intraabdominal pressure in laparoscopic abdominal surgeries|Every 15 minutes during anesthesia, up to 3 hours﻿|||cmH2O||Standard Deviation|Mean
848433|NCT02617901|Primary|Bone Age as Assessed by DXA|Interclass correlation (for observer agreement between radiographs and DXA)|18 months|Children presenting to Endocrine Clinic||Intraclass correlation|||Number
848434|NCT02524054|Secondary|Urine Output - mL|"Diuresis is an expected effect of furosemide. To the extent that aerosol furosemide is absorbed in the blood, diuresis is an expected 'side effect' of this treatment.
Following intervention, study team will measure urine output (mL). Study team will then rehydrate subject with an equal amount of liquid to their output."|Summation of total urine output (mL) at 1 hour following drug administration.|The 17 participants in 'Aerosol furosemide Study 2b' and 'Aerosol saline Study 2b' are the results from the same 17 subjects on two different test days.||ml of urine||Standard Deviation|Mean
848435|NCT02524054|Primary|Change in Subject Rating of Breathing Discomfort (Dyspnea) Before and After Treatment.|"Subjects will rate breathing discomfort (dyspnea) during a 15 min exercise test using a visual analog scale before and after drug (or placebo) intervention. The treatment effect was measured as the rating of breathing discomfort rating before treatment minus the rating of breathing discomfort after treatment at equivalent work intensities.
Outcome Measure Time Frame: subjects performed arm exercise to induce dyspnea for approximately 15 min before and after aerosol inhalation. the average number of minutes between end of drug administration and post-intervention breathing discomfort rating:
Aerosol furosemide Study 2a arm: 38.7 minutes; Aerosol furosemide Study 2b arm: 21.8 minutes; Aerosol saline Study 2b arm: 21.3 minutes"|15 min|||units on a scale||Standard Deviation|Mean
848436|NCT02336594|Secondary|Incidence of Treatment-Emergent Adverse Events||7 weeks.|||Number of Participants|||Number
848437|NCT02336594|Secondary|Single Dose Pharmacodynamics (PD) Profile of RDEA3170 From Serum and Urine|PD profiles of uric acid from serum and urine. PD parameters were evaluated to assess whether any potential differences in PK for the 2 different tablets resulted in differences in uric acid excretion.|Day -1: -24, -23, -22, -21, -20, -18, -16, -14, and -12 hours predose. Days 1, 5, 9, and 13: predose (within 30 minutes prior to dosing) and 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose.|||Percent||Standard Error|Mean
848438|NCT02336594|Primary|AUC∞: Effect of Low Fat Meal on the PK of RDEA3170 Tablets|AUC∞ of RDEA3170 in low-fat fed state.|Days 1 to 9 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.|||ng·hr/mL||95% Confidence Interval|Geometric Mean
848439|NCT02336594|Primary|AUC Last: Effect of Low Fat Meal on the PK of RDEA3170 Tablets|AUC last of RDEA3170 in low-fat fed state.|Days 1 to 9 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.|||ng·hr/mL||95% Confidence Interval|Geometric Mean
848440|NCT02336594|Primary|Cmax: Effect of Low Fat Meal on the PK of RDEA3170 Tablets|Cmax of RDEA3170 in low-fat fed state.|Days 1 to 9 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.|||ng/mL||95% Confidence Interval|Geometric Mean
848441|NCT02336594|Primary|AUC∞: Effect of High Fat Meal on the PK of RDEA3170 Tablets|AUC∞ of RDEA3170 in high-fat fed state.|Days 1 to 13 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.|||ng·hr/mL||95% Confidence Interval|Geometric Mean
848442|NCT02336594|Primary|AUC Last: Effect of High Fat Meal on the PK of RDEA3170 Tablets|AUC last of RDEA3170 in high-fat fed state.|Days 1 to 13 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.|||ng·hr/mL||95% Confidence Interval|Geometric Mean
848443|NCT02336594|Primary|Cmax: Effect of High Fat Meal on the PK of RDEA3170 Tablets|Cmax of RDEA3170 in high-fat fed state.|Days 1 to 13 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.|||ng/mL||95% Confidence Interval|Geometric Mean
848444|NCT02336594|Primary|Apparent Terminal Half-life (t1/2)|t1/2 of RDEA3170 following various treatments.|Days 1 and 5 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.|||hr||95% Confidence Interval|Geometric Mean
848445|NCT02336594|Primary|Area Under the Concentration-time Curve From 0 to Infinity (AUC∞)|AUC∞ of RDEA3170 the fasted condition.|Days 1 and 5 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.|||ng·hr/mL||95% Confidence Interval|Geometric Mean
848446|NCT02336594|Primary|Area Under the Concentration-time Curve From Time Zero to the Quantifiable Last Sampling Timepoint (AUC Last)|AUC last of RDEA3170 in fasted condition.|Days 1 and 5 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.|||ng·hr/mL||95% Confidence Interval|Geometric Mean
848447|NCT02336594|Primary|Time of Occurrence of Maximum Observed Concentration (Tmax)|Tmax of RDEA3170 following various treatments.|Days 1 and 5 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.|||hr||Full Range|Median
848448|NCT02336594|Primary|Maximum Observed Plasma Concentration (Cmax)|Cmax of RDEA3170 in fasted condition.|Days 1 and 5 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.|||ng/mL||95% Confidence Interval|Geometric Mean
848449|NCT02191137|Secondary|Change From Week 16 to Week 24 in the 6MWD (Completers Analysis Set Only)|Six-minute walk distance (6MWD) was conducted to test the physical limitations of the patient by assessing the patient’s exercise capacity. The distance walked by the patient in 6 minutes was measured.|Week 16 to Week 24|The Completers analysis set included patients valid for Safety/ITT analysis sets who had an LPH score at baseline (Visit 1), Week 4, Week 16, and Week 24. 57 patients in Completer analysis set were evaluable for 6MWD at week 24.||Meters||Standard Deviation|Mean
848450|NCT02191137|Secondary|Change From Baseline to Weeks 16 and 24 in the 6MWD|"Six-minute walk distance (6MWD) was conducted to test the physical limitations of the patient by assessing the patient’s exercise capacity. The distance walked by the patient in 6 minutes was measured. In the below table, N signifies subjects who were evaluable for the specific parameter at that timepoint."|Week 16 to Week 24|The ITT analysis set was synonymous with the Safety analysis set definition which included all patients who received at least 1 dose of test drug. 67 patients were evaluable for 6MWD at week 24.||Meters||Standard Deviation|Mean
848451|NCT02191137|Secondary|Change From Week 16 to Week 24 in the Modified Borg Dyspnea Scale (Completers Analysis Set Only)|The Modified Borg Dyspnea Scale assessed the intensity of the patient’s dyspnea from 0 (best) to 10 (worst).|Week 16 to Week 24|The Completers analysis set included patients valid for Safety/ITT analysis sets who had an LPH score at baseline (Visit 1), Week 4, Week 16, and Week 24. 57 patients in Completer analysis set were evaluable for Modified Borg Dyspnea Scale at Week 24.||Scores||Standard Deviation|Mean
848452|NCT02191137|Secondary|Change From Baseline to Weeks 16 and 24 in the Modified Borg Dyspnea Scale|"The Modified Borg Dyspnea Scale assessed the intensity of the patient’s dyspnea from 0 (best) to 10 (worst). In the below table, N signifies subjects who were evaluable for the specific parameter at that timepoint."|Week 16 to Week 24|The ITT analysis set was synonymous with the Safety analysis set definition which included all patients who received at least 1 dose of test drug. 58 patients were evaluable for Modified Borg Dyspnea Scale at week 24.||Scores||Standard Deviation|Mean
848453|NCT02191137|Secondary|Change From Week 16 to Week 24 in the WHO Functional Class (Completers Analysis Set Only)|"Functional class was determined by the WHO classification:
I: Patients with PH (pulmonary hypertension) but without resulting limitation of physical activity. Ordinary physical activity does not cause undue dyspnea or fatigue, chest pain, or near syncope.
II: Patients with PH resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity causes undue dyspnea or fatigue, chest pain, or near syncope.
III: Patients with PH resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes undue dyspnea or fatigue, chest pain, or near syncope.
IV: Patients with PH with inability to carry out any physical activity without symptoms. These patients manifest signs of right-heart failure. Dyspnea and/or fatigue may even be present at rest. Discomfort is increased by any physical activity."|Week 16 to Week 24|The Completers analysis set included patients valid for Safety/ITT analysis sets who had an LPH score at baseline (Visit 1), Week 4, Week 16, and Week 24. 57 patients in Completer analysis set were evaluable for WHO Function Class at Week 24.||Percentage of participants|||Number
848454|NCT02191137|Secondary|Change From Baseline to Weeks 4, 16, and 24 in the WHO Functional Class|"Functional class was determined by the WHO classification:
I: Patients with PH (pulmonary hypertension) but without resulting limitation of physical activity. Ordinary physical activity does not cause undue dyspnea or fatigue, chest pain, or near syncope.
II: Patients with PH resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity causes undue dyspnea or fatigue, chest pain, or near syncope.
III: Patients with PH resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes undue dyspnea or fatigue, chest pain, or near syncope.
IV: Patients with PH with inability to carry out any physical activity without symptoms. These patients manifest signs of right-heart failure. Dyspnea and/or fatigue may even be present at rest. Discomfort is increased by any physical activity.
In the below table, N signifies subjects who were evaluable for the specific parameter at that timepoint."|Baseline to Week 4, Week 16 and Week 24|The ITT analysis set was synonymous with the Safety analysis set definition which included all patients who received at least 1 dose of test drug. 75 patients were evaluable for WHO Function Class at Week 16 or Last Before.||Percentage of participants|||Number
848455|NCT02191137|Secondary|Change From Week 16 to Week 24 in the SF-12 PCS Score and MCS Score (Completers Analysis Set Only)|SF-12v2® Health Survey is a 12-item questionnaire to measure functional health and well-being from the patient’s point of view. Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.|Week 16 to Week 24|The Completers analysis set included patients valid for Safety/ITT analysis sets who had an LPH score at baseline (Visit 1), Week 4, Week 16, and Week 24. 58 patients in Completer analysis set were evaluable for PCS and MCS at Week 24.||Scores||Standard Deviation|Mean
848456|NCT02191137|Secondary|Change From Baseline to Weeks 4, 16, and 24 in the Short Form-12 Health Survey (SF-12) Physical Component Summary (PCS) Score and Mental Component Summary (MCS) Score|"SF-12v2® Health Survey is a 12-item questionnaire to measure functional health and well-being from the patient’s point of view. Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. In the below table, N signifies subjects who were evaluable for the specific parameter at that timepoint."|Baseline to Week 4, Week 16 and Week 24|The ITT analysis set was synonymous with the Safety analysis set definition which included all patients who received at least 1 dose of test drug. 73 patients were evaluable for PCS and MCS at Week 4.||Scores||Standard Deviation|Mean
848457|NCT02191137|Secondary|Change From Week 16 to Week 24 in the WLQ Percentage of Productivity Loss (Completers Analysis Set Only)|The WLQ is an 8-item questionnaire that measures the degree to which employed individuals are experiencing limitations on-the-job due to their health problems, and health-related productivity loss (Presenteeism). The WLQ's terms are aggregated into four scales (i.e. Time Management, Physical demands, Mental-interpersonal demands, Output demands). Using an algorithm, WLQ scale scores can be converted into an estimate of productivity loss.|Week 16 to Week 24|The Completers analysis set included patients valid for Safety/ITT analysis sets who had an LPH score at baseline (Visit 1), Week 4, Week 16, and Week 24. 40 patients in Completer analysis set were evaluable for WLQ percentage of productivity loss at week 24.||Percentage||Standard Deviation|Mean
848458|NCT02191137|Secondary|Change From Week 16 to Week 24 in the WLQ Time Management, Physical Demands, Mental-Interpersonal Demands, and Output Demands Scores (Completers Analysis Set Only)|The Work Limitations Questionnaire (WLQ) is an 8-item questionnaire that measures the degree to which employed individuals are experiencing limitations on-the-job due to their health problems, and health-related productivity loss (Presenteeism). The WLQ's terms are aggregated into four scales (i.e. Time Management, Physical demands, Mental-interpersonal demands, Output demands). Scale score range from 0 (limited none of the time) to 100 (limited all of the time) and represent the reported amount of time in the prior two weeks respondents were limited on-the-job.|Week 16 to Week 24|The Completers analysis set included patients valid for Safety/ITT analysis sets who had an LPH score at baseline (Visit 1), Week 4, Week 16, and Week 24. 40 patients in Completer analysis set were evaluable for WLQ at Week 24.||Scores||Standard Deviation|Mean
848480|NCT02187861|Secondary|Overall Survival (OS)|OS was defined as the period from the date of treatment initiation (Safety Run-in and Arm A) or randomization date (Arms B and C) to death due to any cause. For participants who are alive, OS was censored at the last contact. OS was calculated using Kaplan-Meier method.|Baseline until death due to any cause (assessed up to approximately 2.5 years [cut-off date 06 April 2017])|ITT population||months||95% Confidence Interval|Median
848481|NCT02187861|Secondary|Percentage of Participants Who Died Due to Any Cause||Baseline until death due to any cause (assessed up to approximately 2.5 years [cut-off date 06 April 2017])|ITT population||percentage of participants|||Number
848459|NCT02191137|Secondary|Change From Baseline to Weeks 4, 16, and 24 in the WLQ Percentage of Productivity Loss|"The WLQ is an 8-item questionnaire that measures the degree to which employed individuals are experiencing limitations on-the-job due to their health problems, and health-related productivity loss (Presenteeism). The WLQ's terms are aggregated into four scales (i.e. Time Management, Physical demands, Mental-interpersonal demands, Output demands). Using an algorithm, WLQ scale scores can be converted into an estimate of productivity loss. In the below table, N signifies subjects who were evaluable for the specific parameter at that timepoint."|Baseline to Week 4, Week 16 and Week 24|The ITT analysis set was synonymous with the Safety analysis set definition which included all patients who received at least 1 dose of test drug. 37 patients were evaluable for WLQ percentage of productivity loss at week 4.||Percentage||Standard Deviation|Mean
848460|NCT02191137|Secondary|Change From Baseline to Weeks 4, 16, and 24 in the WLQ Time Management, Physical Demands, Mental-Interpersonal Demands and Output Demands Scores|"The Work Limitations Questionnaire (WLQ) is an 8-item questionnaire that measures the degree to which employed individuals are experiencing limitations on-the-job due to their health problems, and health-related productivity loss (Presenteeism). The WLQ's terms are aggregated into four scales (i.e. Time Management, Physical demands, Mental-interpersonal demands, Output demands). Scale score range from 0 (limited none of the time) to 100 (limited all of the time) and represent the reported amount of time in the prior two weeks respondents were limited on-the-job. In the below table, N signifies subjects who were evaluable for the specific parameter at that timepoint."|Baseline to Week 4, Week 16 and Week 24|The ITT analysis set was synonymous with the Safety analysis set definition which included all patients who received at least 1 dose of test drug. 52 patients were evaluable for WLQ at week 4.||Scores||Standard Deviation|Mean
848461|NCT02191137|Secondary|Percentage of Patients With an MCID From Week 16 in Emotional Dimension Score at Week 24 (Completers Analysis Set Only)|For the physical and emotional dimension scores, the MCID was a 4-point decrease.|Week 16 to Week 24|The Completers analysis set included patients valid for Safety/ITT analysis sets who had an LPH score at baseline (Visit 1), Week 4, Week 16, and Week 24. 58 patients in Completer analysis set were evaluable for LPH emotional dimension score at Week 24.||Percentage of Participants|||Number
848462|NCT02191137|Secondary|Percentage of Patients With an MCID From Week 16 in Physical Dimension Score at Week 24 (Completers Analysis Set Only)|For the physical and emotional dimension scores, the MCID was a 4-point decrease.|Week 16 to Week 24|The Completers analysis set included patients valid for Safety/ITT analysis sets who had an LPH score at baseline (Visit 1), Week 4, Week 16, and Week 24. 57 patients were evaluable for LPH physical dimension score at week 24.||Percentage of Participants|||Number
848463|NCT02191137|Secondary|Percentage of Patients With an MCID From Week 16 in LPH Total Score at Week 24 (Completers Analysis Set Only)|For LPH total score, the MCID was an 11-point decrease.|Week 16 to Week 24|The Completers analysis set included patients valid for Safety/ITT analysis sets who had an LPH score at baseline (Visit 1), Week 4, Week 16, and Week 24. 58 patients in Completer analysis set were evaluable for LPH total score at Week 24.||Percentage of Participants|||Number
848464|NCT02191137|Secondary|Percentage of Patients With an MCID From Baseline in LPH Emotional Dimension Score at Weeks 4, 16, and 24|"For the physical and emotional dimension scores, the MCID was a 4-point decrease. In the below table, N signifies subjects who were evaluable for the specific parameter at that timepoint."|Baseline to Week 4, Week 16 and Week 24|The ITT analysis set was synonymous with the Safety analysis set definition which included all patients who received at least 1 dose of test drug. 72 patients were evaluable for LPH emotional dimension score at week 4.||Percentage of Participants|||Number
848465|NCT02191137|Secondary|Percentage of Patients With an MCID From Baseline in LPH Physical Dimension Score at Weeks 4, 16, and 24|"For the physical and emotional dimension scores, the MCID was a 4-point decrease. In the below table, N signifies subjects who were evaluable for the specific parameter at that timepoint."|Baseline to Week 4, Week 16 and Week 24|The ITT analysis set was synonymous with the Safety analysis set definition which included all patients who received at least 1 dose of test drug. 72 patients were evaluable for LPH physical dimension score at week 4.||Percentage of Participants|||Number
848466|NCT02191137|Secondary|Percentage of Patients With a Minimal Clinically Significant Important Difference (MCID) From Baseline in LPH Total Score at Weeks 4, 16, and 24|"For LPH total score, the MCID was an 11-point decrease from baseline. In the below table, N signifies subjects who were evaluable for the specific parameter at that timepoint."|Baseline to Week 4, Week 16 and Week 24|The ITT analysis set was synonymous with the Safety analysis set definition which included all patients who received at least 1 dose of test drug. 72 patients were evaluable for LPH total score at week 4.||Percentage of participants|||Number
848467|NCT02191137|Secondary|Change From Week 16 to Week 24 in the LPH Emotional Dimension Score (Completers Analysis Set Only)|The LPH derived from the Minnesota Living with Heart Failure questionnaire comprises 21 items, responded to on a 6-point Likert scale ranging from 0 'No’ to 5 ’Very much’. A total score ranging from 0 to 105 is calculated by summing the responses to all 21 questions. A physical dimension score (range 0-40, 8 items) and an emotional dimension score (range 0-25, 5 items) can also be calculated. For all LPH scores, a higher score indicates that patients are more affected by their medical condition.|Week 16 to Week 24|The Completers analysis set included patients valid for Safety/ITT analysis sets who had an LPH score at baseline (Visit 1), Week 4, Week 16, and Week 24. 58 patients in Completer analysis set were evaluable for LPH emotional dimension score at Week 24.||Scores||Standard Deviation|Mean
848468|NCT02191137|Secondary|Change From Baseline to Weeks 4, 16, and 24 in the LPH Emotional Dimension Score|"The LPH derived from the Minnesota Living with Heart Failure questionnaire comprises 21 items, responded to on a 6-point Likert scale ranging from 0 'No’ to 5 ’Very much’. A total score ranging from 0 to 105 is calculated by summing the responses to all 21 questions. A physical dimension score (range 0-40, 8 items) and an emotional dimension score (range 0-25, 5 items) can also be calculated. For all LPH scores, a higher score indicates that patients are more affected by their medical condition. In the below table, N signifies subjects who were evaluable for the specific parameter at that timepoint."|Baseline to Week 4, Week 16 and Week 24|The ITT analysis set was synonymous with the Safety analysis set definition which included all patients who received at least 1 dose of test drug. 75 patients were evaluable for LPH emotional dimension score at week 16 or before.||Scores||Standard Deviation|Mean
848500|NCT02128997|Secondary|Pain Scores|On postoperative day 2, all patients were administered a pain scale: Rank sharp pain (0–10), 10 being worst possible sharp pain.|Postpartum day 2|||Unit on a scale||Inter-Quartile Range|Median
848469|NCT02191137|Secondary|Change From Week 16 to Week 24 in the LPH Physical Dimension Score (Completers Analysis Set Only)|The LPH derived from the Minnesota Living with Heart Failure questionnaire comprises 21 items, responded to on a 6-point Likert scale ranging from 0 'No’ to 5 ’Very much’. A total score ranging from 0 to 105 is calculated by summing the responses to all 21 questions. A physical dimension score (range 0-40, 8 items) and an emotional dimension score (range 0-25, 5 items) can also be calculated. For all LPH scores, a higher score indicates that patients are more affected by their medical condition.|Week 16 to Week 24|The Completers analysis set included patients valid for Safety/ITT analysis sets who had an LPH score at baseline (Visit 1), Week 4, Week 16, and Week 24. 57 patients in Completer analysis set were evaluable for LPH physical dimension score at Week 24.||Scores||Standard Deviation|Mean
848470|NCT02191137|Secondary|Change From Baseline to Weeks 4, 16, and 24 in the LPH Physical Dimension Score|"The LPH derived from the Minnesota Living with Heart Failure questionnaire comprises 21 items, responded to on a 6-point Likert scale ranging from 0 'No’ to 5 ’Very much’. A total score ranging from 0 to 105 is calculated by summing the responses to all 21 questions. A physical dimension score (range 0-40, 8 items) and an emotional dimension score (range 0-25, 5 items) can also be calculated. For all LPH scores, a higher score indicates that patients are more affected by their medical condition. In the below table, N signifies subjects who were evaluable for the specific parameter at that timepoint."|Baseline to Weeks 4, 16, and 24|The ITT analysis set was synonymous with the Safety analysis set definition which included all patients who received at least 1 dose of test drug. 75 patients were evaluable for LPH physical dimension score at week 16 or before.||Scores||Standard Deviation|Mean
848471|NCT02191137|Secondary|Change From Week 16 to Week 24 in the LPH Total Score (Completers Analysis Set Only)|The Living with Pulmonary Hypertension (LPH) questionnaire with Heart Failure questionnaire comprises 21 items, responded to on a 6-point Likert scale ranging from 0 'No' to 5 'Very much'. A total score ranging from 0 (best) to 105 (worst) is calculated by summing the responses to all 21 questions.|Week 16 to Week 24|The Completers analysis set included patients valid for Safety/ITT analysis sets who had an LPH score at baseline (Visit 1), Week 4, Week 16, and Week 24. 58 patients in Completer analysis set were evaluable for LPH total score at Week 24.||Scores||Standard Deviation|Mean
848472|NCT02191137|Secondary|Change From Baseline to Weeks 4 and 16 in the LPH Total Score|"The Living with Pulmonary Hypertension (LPH) questionnaire with Heart Failure questionnaire comprises 21 items, responded to on a 6-point Likert scale ranging from 0 'No' to 5 'Very much'. A total score ranging from 0 (best) to 105 (worst) is calculated by summing the responses to all 21 questions. In the below table, N signifies subjects who were evaluable for the specific parameter at that timepoint."|Baseline to Week 4 and Week 16|The ITT analysis set was synonymous with the Safety analysis set definition which included all patients who received at least 1 dose of test drug. 72 patients were evaluable for LPH total score at Week 4.||Scores||Standard Deviation|Mean
848473|NCT02191137|Primary|Change From Baseline to Week 24 in the Living With Pulmonary Hypertension (LPH) Questionnaire Total Score|The Living with Pulmonary Hypertension (LPH) questionnaire with Heart Failure questionnaire comprises 21 items, responded to on a 6-point Likert scale ranging from 0 'No’ to 5 ’Very much’. A total score ranging from 0 (best) to 105 (worst) is calculated by summing the responses to all 21 questions.|Baseline to Week 24|The ITT analysis set was synonymous with the Safety analysis set definition which included all patients who received at least 1 dose of test drug. 66 patients were evaluable for LPH total score at Week 24.||Scores||Standard Deviation|Mean
848474|NCT02187861|Secondary|Area Under the Plasma Concentration-Time Curve From Time 0 to 8 Hours Post Dose (AUC0-8h) of Venetoclax|Area under the plasma concentration versus time curve from time 0 (pre-dose) to 8 hours post dose (AUC0-8h).|Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days)|Pharmacokinetic-evaluable population. ‘Overall number of participants analyzed’=those evaluable for this outcome measure.||hours*ng/mL||Standard Deviation|Mean
848475|NCT02187861|Secondary|Area Under the Plasma Concentration-Time Curve From Time 0 to Last Observed Concentration (AUClast) of Venetoclax|Area under the plasma concentration versus time curve from zero to the last measured concentration (AUClast).|Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days)|Pharmacokinetic-evaluable population||hours*ng/mL||Standard Deviation|Mean
848476|NCT02187861|Secondary|Maximum Plasma Concentration (Cmax) of Venetoclax||Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days)|Pharmacokinetic-evaluable population||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
848477|NCT02187861|Secondary|Time to Maximum Plasma Concentration (Tmax) of Venetoclax||Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days)|Pharmacokinetic-evaluable population included all enrolled participants with available pharmacokinetic data for venetoclax.||hours||Full Range|Median
848478|NCT02187861|Secondary|Apparent Volume of Distribution (Vd) of Venetoclax|Vd was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.|Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days)|The data could not be collected as the timepoints for pharmacokinetics collection and the daily dosing of venetoclax did not permit an assessment of Vd.|||||
848479|NCT02187861|Secondary|Apparent Clearance (CL) of Venetoclax|CL is a quantitative measure of the rate at which a drug substance is removed from the body.|Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days)|The data could not be collected as the timepoints for pharmacokinetics collection and the daily dosing of venetoclax did not permit an assessment of CL.|||||
848501|NCT02128997|Primary|Number of Participants With Wound Complications|The primary outcome variable was a composite of wound morbidity at 4 weeks postpartum including SSI and/or wound opening|Four weeks after cesarean section|||Participants|||Count of Participants
848482|NCT02187861|Secondary|Event-Free Survival (EFS) According to Investigator as Per Lugano Classification, Using PET and/or CT Scan|EFS was defined as the period from the date of treatment initiation (Safety Run-in and Arm A) or randomization date (Arms B and C) to the date of disease progression, death, or start of a new anti-lymphoma therapy whichever occurred first. PD: a score 4 (uptake moderately >liver) or 5 (uptake markedly >liver and/or new lesions) with increase in intensity of uptake from baseline on PET 5-PS for individual target nodes/nodal lesions; new FDG-avid foci for extranodal lesions; new FDG-avid foci consistent with lymphoma for new lesions; or new or recurrent FDG-avid foci for bone marrow. Assessment was performed by Investigator according to Lugano classification using PET and/or CT scan. EFS was calculated using Kaplan-Meier method.|Baseline until disease progression, death, or start of a new anti-lymphoma therapy whichever occurred first (assessed up to approximately 2.5 years [cut-off date 06 April 2017])|ITT population||months||95% Confidence Interval|Median
848483|NCT02187861|Secondary|Percentage of Participants With Disease Progression (According to Investigator as Per Lugano Classification, Using PET and/or CT Scan), Death, or Start of a New Anti-lymphoma Therapy|PD: a score 4 (uptake moderately >liver) or 5 (uptake markedly >liver and/or new lesions) with increase in intensity of uptake from baseline on PET 5-PS for individual target nodes/nodal lesions; new FDG-avid foci for extranodal lesions; new FDG-avid foci consistent with lymphoma for new lesions; or new or recurrent FDG-avid foci for bone marrow. Assessment was performed by Investigator according to Lugano classification using PET and/or CT scan.|Baseline until disease progression, death, or start of a new anti-lymphoma therapy whichever occurred first (assessed up to approximately 2.5 years [cut-off date 06 April 2017])|ITT population||percentage of participants|||Number
848484|NCT02187861|Secondary|Progression-Free Survival (PFS) According to Investigator as Per Lugano Classification, Using PET and/or CT Scan|PFS was defined as the period from the date of treatment initiation (Safety Run-in and Arm A) or randomization date (Arms B and C) until the date of disease progression, or death due to any cause. PD: a score 4 (uptake moderately >liver) or 5 (uptake markedly >liver and/or new lesions) with increase in intensity of uptake from baseline on PET 5-PS for individual target nodes/nodal lesions; new FDG-avid foci for extranodal lesions; new FDG-avid foci consistent with lymphoma for new lesions; or new or recurrent FDG-avid foci for bone marrow. Assessment was performed by Investigator according to Lugano classification using PET and/or CT scan. PFS was calculated using Kaplan-Meier method.|Baseline until disease progression or death due to any cause (assessed up to approximately 2.5 years [cut-off date 06 April 2017])|ITT population||months||95% Confidence Interval|Median
848485|NCT02187861|Secondary|Percentage of Participants With Disease Progression (According to Investigator as Per Lugano Classification, Using PET and/or CT Scan) or Death|PD: a score 4 (uptake moderately >liver) or 5 (uptake markedly >liver and/or new lesions) with increase in intensity of uptake from baseline on PET 5-PS for individual target nodes/nodal lesions; new FDG-avid foci for extranodal lesions; new FDG-avid foci consistent with lymphoma for new lesions; or new or recurrent FDG-avid foci for bone marrow. Assessment was performed by Investigator according to Lugano classification using PET and/or CT scan.|Baseline until disease progression or death due to any cause (assessed up to approximately 2.5 years [cut-off date 06 April 2017])|ITT population||percentage of participants|||Number
848486|NCT02187861|Secondary|Duration of Response (DOR) According to Investigator as Per Lugano Classification, Using PET and/or CT Scan|DOR was defined as time from CMR/CR or PMR/PR until progressive disease (PD) or death due to any cause. CMR, CR, PMR, and PR have been defined in previous endpoints, and are not repeated here due to space constraint. PD: a score 4 (uptake moderately >liver) or 5 (uptake markedly >liver and/or new lesions) with increase in intensity of uptake from baseline on PET 5-PS for individual target nodes/nodal lesions; new FDG-avid foci for extranodal lesions; new FDG-avid foci consistent with lymphoma for new lesions; or new or recurrent FDG-avid foci for bone marrow. Assessment was performed by Investigator according to Lugano classification using PET and/or CT scan. DOR was calculated using Kaplan-Meier method.|From CMR or PMR until disease progression or death due to any cause (assessed up to approximately 2.5 years [cut-off date 06 April 2017])|ITT population. ‘Overall number of participants analyzed’=those evaluable for this outcome measure.||months||95% Confidence Interval|Median
848487|NCT02187861|Secondary|Percentage of Participants With OR According to Investigator as Per Lugano Classification, Using PET and/or CT Scan up to Data Cut-off (06 April 2017)|OR was defined as CMR/CR or PMR/PR. CMR, CR, PMR, and PR have been defined in previous endpoints, and are not repeated here due to space constraint. Assessment was performed by Investigator according to Lugano classification using PET and/or CT scan.|Baseline until disease progression or death due to any cause (assessed up to approximately 2.5 years [cut-off date 06 April 2017])|ITT population. ‘Overall number of participants analyzed’=those evaluable for this outcome measure.||percentage of participants|||Number
848488|NCT02187861|Secondary|Percentage of Participants With OR According to Investigator as Per Lugano Classification, Using CT Scan|OR was defined as CR or PR. CR: reduction of LDi of target nodes/nodal masses to <=1.5 cm, and no extralymphatic sites of disease; absence of non-measured lesions and new lesions; reduction of enlarged organs to normal; and normal/IHC-negative bone marrow morphology. PR: >=50% decrease in SPD of up to 6 target measurable nodes and extra-nodal sites; absence/reduction/no increase in size of non-measured lesions; reduction in length of spleen at least >50% beyond normal; and no new lesions. Assessment was performed by Investigator according to Lugano classification using CT scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.|6−8 weeks after Cycle 6 Day 1 (Cycle length = 28 days), Year 1|ITT population||percentage of participants||95% Confidence Interval|Number
848489|NCT02187861|Secondary|Percentage of Participants With OR According to IRC as Per Lugano Classification, Using CT Scan|OR was defined as CR or Partial Response (PR). CR: reduction of LDi of target nodes/nodal masses to <=1.5 cm, and no extralymphatic sites of disease; absence of non-measured lesions and new lesions; reduction of enlarged organs to normal; and normal/IHC-negative bone marrow morphology. If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PR: greater than or equal to (>=) 50 percent (%) decrease in sum of the product of the perpendicular diameters (SPD) of up to 6 target measurable nodes and extra-nodal sites; absence/reduction/no increase in size of non-measured lesions; reduction in length of spleen at least >50% beyond normal; and no new lesions. Assessment was performed by an IRC according to Lugano classification using CT scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.|6−8 weeks after Cycle 6 Day 1 (Cycle length = 28 days), Year 1|ITT population||percentage of participants||95% Confidence Interval|Number
848490|NCT02187861|Secondary|Percentage of Participants With OR According to Investigator as Per Lugano Classification, Using PET Scan|OR was defined as CMR or PMR. CMR: a score 1 (no uptake above background), 2 (uptake <=mediastinum), or 3 (<mediastinum but <=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites with no new lesions and no evidence of FDG-avid disease in bone marrow. If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PMR: a score 4 (uptake moderately >liver) or 5 (uptake markedly >liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites with no new lesions and reduced residual uptake in bone marrow compared with baseline. Assessment was performed by Investigator according to Lugano classification using PET scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.|6−8 weeks after Cycle 6 Day 1 (Cycle length = 28 days), Year 1|ITT population||percentage of participants||95% Confidence Interval|Number
848491|NCT02187861|Secondary|Percentage of Participants With Objective Response (OR) According to IRC as Per Modified Lugano Classification, Using PET Scan|OR was defined as CMR or Partial Metabolic Response (PMR). CMR: a score 1 (no uptake above background), 2 (uptake <=mediastinum), or 3 (<mediastinum but <=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites with no new lesions and no evidence of FDG-avid disease in bone marrow. If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PMR: a score 4 (uptake moderately greater than [>] liver) or 5 (uptake markedly >liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites with no new lesions and reduced residual uptake in bone marrow compared with baseline. Assessment was performed by an IRC according to Modified Lugano classification using PET scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.|6−8 weeks after Cycle 6 Day 1 (Cycle length = 28 days), Year 1|ITT population||percentage of participants||95% Confidence Interval|Number
848492|NCT02187861|Secondary|Percentage of Participants With CR According to Investigator as Per Lugano Classification, Using CT Scan|CR: defined as reduction of LDi of target nodes/nodal masses to <=1.5 cm, and no extralymphatic sites of disease; absence of non-measured lesions and new lesions; reduction of enlarged organs to normal; and normal/IHC-negative bone marrow morphology. Assessment was performed by Investigator according to Lugano classification using CT scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.|6−8 weeks after Cycle 6 Day 1 (Cycle length = 28 days), Year 1|ITT population||percentage of participants||95% Confidence Interval|Number
848493|NCT02187861|Secondary|Percentage of Participants With Complete Response (CR) According to IRC as Per Lugano Classification, Using Computed Tomography (CT) Scan|CR: defined as reduction of longest transverse diameter of lesion (LDi) of target nodes/nodal masses to <=1.5 centimeters (cm), and no extralymphatic sites of disease; absence of non-measured lesions and new lesions; reduction of enlarged organs to normal; and normal/immunohistochemistry (IHC)-negative bone marrow morphology. If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. Assessment was performed by an IRC according to Lugano classification using CT scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.|6−8 weeks after Cycle 6 Day 1 (Cycle length = 28 days), Year 1|ITT population||percentage of participants||95% Confidence Interval|Number
848494|NCT02187861|Secondary|Percentage of Participants With CMR According to Investigator as Per Lugano Classification, Using PET Scan at Year 1|CMR: a score 1 (no uptake above background), 2 (uptake <=mediastinum), or 3 (<mediastinum but <=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites with no new lesions and no evidence of FDG-avid disease in bone marrow. Assessment was performed by Investigator according to Lugano classification using PET scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.|Year 1|ITT population||percentage of participants||95% Confidence Interval|Number
848495|NCT02187861|Secondary|Percentage of Participants With CMR According to IRC as Per Modified Lugano Classification, Using PET Scan at Year 1|CMR: a score 1 (no uptake above background), 2 (uptake <=mediastinum), or 3 (uptake <mediastinum but <=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites with no new lesions and no evidence of FDG-avid disease in bone marrow. If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. Assessment was performed by an IRC according to Modified Lugano classification using PET scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.|Year 1|ITT population||percentage of participants||95% Confidence Interval|Number
848496|NCT02187861|Secondary|Percentage of Participants With CMR According to Investigator as Per Lugano Classification, Using PET Scan at PRA|CMR: a score 1 (no uptake above background), 2 (uptake <=mediastinum), or 3 (<mediastinum but <=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites with no new lesions and no evidence of FDG-avid disease in bone marrow. Assessment was performed by Investigator according to Lugano classification using PET scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.|6-8 weeks after Cycle 6 Day 1 (Cycle length = 28 days)|ITT population||percentage of participants||95% Confidence Interval|Number
848497|NCT02187861|Primary|Percentage of Participants With Complete Metabolic Response (CMR) According to Independent Review Committee (IRC) as Per Modified Lugano Classification, Using Positron Emission Tomography (PET) Scan at Primary Response Assessment (PRA)|CMR: a score 1 (no uptake above background), 2 (uptake less than or equal to [<=] mediastinum), or 3 (uptake less than [<] mediastinum but <=liver) with or without a residual mass on PET 5-point scale (5-PS), for lymph nodes and extralymphatic sites with no new lesions and no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow. If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. Assessment was performed by an IRC according to Modified Lugano classification using PET scan. 95% confidence interval (CI) for percentage of responders was calculated using Clopper-Pearson method.|6-8 weeks after Cycle 6 Day 1 (PRA) (Cycle length = 28 days)|ITT population||percentage of participants||95% Confidence Interval|Number
848498|NCT02128997|Secondary|Postpartum Length of Stay||Until hospital discharge and then for 4 weeks follow up|||days||Inter-Quartile Range|Median
848499|NCT02128997|Secondary|Tingling Pain Scores|On postoperative day 2, all patients were administered a pain scale: Rank tingling pain (0–10), 10 being worst possible tingling pain|Postpartum day 2|||Unit on a scale||Inter-Quartile Range|Median
848502|NCT02092285|Primary|Percentage of Participants Meeting Partial Mayo Score Response Criteria Through Week 54|The Partial Mayo Score (Mayo Score without endoscopy) measures severity of ulcerative colitis. Three sub-scores for stool frequency, rectal bleeding, and physician’s global assessment are each graded from 0 to 3 with higher scores indicating more severe disease. Individual sub-scores are then summed to provide the total score ranging from 0 (normal or inactive disease) to 9 (severe disease). Clinical response is defined as a decrease in PMS of ≥2 points and ≥30% from baseline, plus either a decrease in rectal bleeding subscore of ≥1 point or an absolute rectal bleeding subscore of ≤1. In this outcome measure, the percentage of participants starting treatment at the start of the Induction Phase (Baseline) who obtained clinical response by the end of the Induction Phase (i.e., by Week 6) and maintained clinical response through Week 54 (i.e., had positive clinical responses at both Weeks 30 and 54) are estimated.|Baseline (Week 0), Week 6, Week 30, Week 54|The analysis population for the evaluation of efficacy during the maintenance period was the Full Analysis Set (FAS205) consisting of participants who received at least 1 dose of golimumab.||Percentage of Participants||95% Confidence Interval|Number
848503|NCT02077140|Other Pre-specified|Subject's Satisfaction With Study Treatment (Exploratory Analysis)|Subject's satisfaction with study treatment as measured by a 5-point categorical scale where 0 = poor, 1 = fair, 2 = good, 3 = very good, and 4 = excellent|up to 72hrs|The efficacy analyses of Cohort 1 to 4 were considered for exploratory analyses.||Participants|||Count of Participants
848504|NCT02077140|Other Pre-specified|Time to First Use of Opioid Analgesia (Exploratory Analysis)||up to 96hrs|The efficacy analyses of Cohort 1 to 4 were considered for exploratory analyses.||hours||95% Confidence Interval|Median
848505|NCT02077140|Other Pre-specified|Total Use of Opioid Analgesia (Exploratory Analysis).||over 0 to 24hrs, 0 to 48hrs, 0 to 72hrs, and 0 to 96hrs|The efficacy analyses of Cohort 1 to 4 were considered for exploratory analyses.||morphine mg equivalent||Standard Deviation|Mean
848506|NCT02077140|Other Pre-specified|Summed Pain Intensity Scores (Exploratory Analysis)|The theoretical range for SPI-24, SPI-48, SPI-72, and SPI-96 is 0 to 230, 0-470, 0-710, and 0-960, respectively, with lower scores indicative of less pain over this time period (i.e., lower scores are consistent with better analgesia). Summed pain intensity is calculated as area under the curve, using the trapezoidal rule to bridge adjacent time points. Specifically, NRS scores for two adjacent time points are averaged and then multiplied by the time span between points (in hours).|over 1 to 24hr, 1 to 48 hrs, 1 to 72hrs, and 1 to 96hrs|The efficacy analyses of Cohort 1 to 4 were considered for exploratory analyses.||units on a scale||Standard Deviation|Mean
848507|NCT02077140|Other Pre-specified|Pharmacokinetic (PK) Parameters of MDT-10013: Terminal Phase Rate Constant (λz)|Blood samples were taken for pharmacokinetic parameters of MDT-10013 determinations before surgery on Day 0; at 1, 2, 4, 6, 8, 12, 24, 48, 72, and 96 hours after Time 0 (96-hour sample for Cohort 4 only); and on Days 7 to 10 after Time 0. Time 0 was defined as the time the capsule was closed.|up to 10 days|PK analysis population consisted of all subjects who had PK samples analyzed.||/hr||Standard Deviation|Mean
848508|NCT02077140|Other Pre-specified|Pharmacokinetic (PK) Parameters of MDT-10013: Terminal Plasma Half-life (t½)|Blood samples were taken for pharmacokinetic parameters of MDT-10013 determinations before surgery on Day 0; at 1, 2, 4, 6, 8, 12, 24, 48, 72, and 96 hours after Time 0 (96-hour sample for Cohort 4 only); and on Days 7 to 10 after Time 0. Time 0 was defined as the time the capsule was closed.|up to 10 days|PK analysis population consisted of all subjects who had PK samples analyzed.||hrs||Standard Deviation|Mean
848509|NCT02077140|Other Pre-specified|Pharmacokinetic (PK) Parameters of MDT-10013: Lag Time Before First Measurable Drug Concentration (Tlag)|Blood samples were taken for pharmacokinetic parameters of MDT-10013 determinations before surgery on Day 0; at 1, 2, 4, 6, 8, 12, 24, 48, 72, and 96 hours after Time 0 (96-hour sample for Cohort 4 only); and on Days 7 to 10 after Time 0. Time 0 was defined as the time the capsule was closed. Actual sampling times after T0 (to 1/1000th of an hour) were used to calculate PK parameters.|up to 10 days|PK analysis population consisted of all subjects who had PK samples analyzed.||hrs||Full Range|Median
848510|NCT02077140|Other Pre-specified|Pharmacokinetic (PK) Parameters of MDT-10013: Time to Maximum Plasma Concentration Observed (Tmax)|Blood samples were taken for pharmacokinetic parameters of MDT-10013 determinations before surgery on Day 0; at 1, 2, 4, 6, 8, 12, 24, 48, 72, and 96 hours after Time 0 (96-hour sample for Cohort 4 only); and on Days 7 to 10 after Time 0. Time 0 was defined as the time the capsule was closed. Actual sampling times after T0 (to 1/1000th of an hour) were used to calculate PK parameters.|up to 10 days|PK analysis population consisted of all subjects who had PK samples analyzed.||hrs||Full Range|Median
848511|NCT02077140|Other Pre-specified|Pharmacokinetic (PK) Parameters of MDT-10013: Maximum Observed Plasma Concentration (Cmax)|Blood samples were taken for pharmacokinetic parameters of MDT-10013 determinations before surgery on Day 0; at 1, 2, 4, 6, 8, 12, 24, 48, 72, and 96 hours after Time 0 (96-hour sample for Cohort 4 only); and on Days 7 to 10 after Time 0. Time 0 was defined as the time the capsule was closed. Actual sampling times after T0 (to 1/1000th of an hour) were used to calculate PK parameters.|up to 10 days|PK analysis population consisted of all subjects who had PK samples analyzed.||pg/mL||Standard Deviation|Mean
848512|NCT02077140|Other Pre-specified|Pharmacokinetic (PK) Parameters of MDT-10013: Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-∞)|Blood samples were taken for pharmacokinetic parameters of MDT-10013 determinations before surgery on Day 0; at 1, 2, 4, 6, 8, 12, 24, 48, 72, and 96 hours after Time 0 (96-hour sample for Cohort 4 only); and on Days 7 to 10 after Time 0. Time 0 was defined as the time the capsule was closed. Actual sampling times after T0 (to 1/1000th of an hour) were used to calculate PK parameters.|up to 10 days|PK analysis population consisted of all subjects who had PK samples analyzed.||h*pg/mL||Standard Deviation|Mean
848513|NCT02077140|Other Pre-specified|Pharmacokinetic (PK) Parameters of MDT-10013: Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC0-t)|Blood samples were taken for pharmacokinetic parameters of MDT-10013 determinations before surgery on Day 0; at 1, 2, 4, 6, 8, 12, 24, 48, 72, and 96 hours after Time 0 (96-hour sample for Cohort 4 only); and on Days 7 to 10 after Time 0. Time 0 was defined as the time the capsule was closed. Actual sampling times after T0 (to 1/1000th of an hour) were used to calculate PK parameters.|up to 10 days|PK analysis population consisted of all subjects who had PK samples analyzed.||h*pg/mL||Standard Deviation|Mean
848514|NCT02077140|Secondary|Subject's Satisfaction With Study Treatment|Subject's satisfaction with study treatment as measured by a 5-point categorical scale where 0 = poor, 1 = fair, 2 = good, 3 = very good, and 4 = excellent|up to 72hrs|The primary efficacy analysis was based on the Full Analysis dataset of Cohort 1 to 3. Full Analysis dataset included Safety population (i.e., all subjects who received at least 1 MDT-10013 strip or completed surgery in a standard-of-care group based on the actual treatment a subject received) having at least 1 postoperative pain assessment.||Participants|||Count of Participants
848515|NCT02077140|Secondary|Time to First Use of Opioid Analgesia||up to 96hrs|The primary efficacy analysis was based on the Full Analysis dataset of Cohort 1 to 3. Full Analysis dataset included Safety population (i.e., all subjects who received at least 1 MDT-10013 strip or completed surgery in a standard-of-care group based on the actual treatment a subject received) having at least 1 postoperative pain assessment.||hours||95% Confidence Interval|Median
848516|NCT02077140|Secondary|Total Use of Opioid Analgesia Over 0 to 24hrs, 0 to 48hrs, 0 to 72hrs, and 0 to 96hrs.|Total use of opioid analgesia over 0 to 24hrs, 0 to 48hrs, 0 to 72hrs, and 0 to 96hrs. The analgesia administered was converted to a morphine equivalent by using a standard conversion table.|over 0 to 24hrs, 0 to 48hrs, 0 to 72hrs, and 0 to 96hrs|The primary efficacy analysis was based on the Full Analysis dataset of Cohort 1 to 3. Full Analysis dataset included Safety population (i.e., all subjects who received at least 1 MDT-10013 strip or completed surgery in a standard-of-care group based on the actual treatment a subject received) having at least 1 postoperative pain assessment.||morphine mg equivalent||Standard Deviation|Mean
848517|NCT02077140|Secondary|Summed Pain Intensity Scores Over 1- 24hrs (SPI-24), 1- 72hrs (SPI-72) and 1- 96hrs (SPI-96)|The theoretical range for SPI-24, SPI-72, and SPI-96 is 0 to 230, 0-710, and 0-960, respectively, with lower scores indicative of less pain over this time period (i.e., lower scores are consistent with better analgesia). Summed pain intensity is calculated as area under the curve, using the trapezoidal rule to bridge adjacent time points. Specifically, NRS scores for two adjacent time points are averaged and then multiplied by the time span between points (in hours).|over 1 to 24hrs, 1 to 72hrs, and 1 to 96hrs|The primary efficacy analysis was based on the Full Analysis dataset of Cohort 1 to 3. Full Analysis dataset included Safety population (i.e., all subjects who received at least 1 MDT-10013 strip or completed surgery in a standard-of-care group based on the actual treatment a subject received) having at least 1 postoperative pain assessment.||units on a scale||Standard Deviation|Mean
848518|NCT02077140|Primary|Summed Pain Intensity Over 1- 48hrs (SPI-48)--Sensitivity Analysis Using Windowed Worst Observation Carried Forward (WOCF)|Similar to SPI-48, the theoretical range for this WOCF adjustment for rescue medication is 0-470, with lower scores indicative of less pain over this time period (i.e., lower scores are consistent with better analgesia). The calculation is identical in terms of area-under the curve using the trapezoidal rule. However, the NRS score at the final assessment prior to each instance of rescue medication is carried forward through for a window based on the approximate half-life of the drug, replacing the raw NRS scores post-rescue for each patient until the end of the pharmacological activity window, at which point calculations revert to raw NRS as applicable. Note that WOCF SPI-48 may include multiple adjustment windows for each patient, depending on the number or rescue events and the active life of the medication selected.|over 1 to 48hrs|The primary efficacy analysis was based on the Full Analysis dataset of Cohort 1 to 3. Full Analysis dataset included Safety population (i.e., all subjects who received at least 1 MDT-10013 strip or completed surgery in a standard-of-care group based on the actual treatment a subject received) having at least 1 postoperative pain assessment.||units on a scale||Standard Deviation|Mean
848519|NCT02077140|Primary|Integrated Summed Pain Intensity Over 1- 48hrs (SPI-48) and Total Opioid Intake in First 48hrs --Sensitivity Analysis Using Silverman Method|This sensitivity analysis is an integrated assessment of summed pain intensity over 1 to 48hrs (SPI-48) and total opioid intake (ME0-48) in first 48hrs. Briefly, subjects were ranked according to SPI-48 regardless of the treatment received (including Standard of Care, SOC). The mean of all the ranks for this variable was calculated. Then, the percent difference for each individual rank from the pooled mean rank was computed. This process was repeated for total opioid intake in the first 48hrs (ME0-48). The integrated endpoint for each subject was the sum of the rank order percent differences for SPI-48 and ME0-48. The theoretical minimum and maximum on the integrated endpoint are -197% and +197% in this study. Lower scores are better, indicative of less pain and/or less opioid intake.|over 1 to 48hrs|The primary efficacy analysis was based on the Full Analysis dataset of Cohort 1 to 3. Full Analysis dataset included Safety population (i.e., all subjects who received at least 1 MDT-10013 strip or completed surgery in a standard-of-care group based on the actual treatment a subject received) having at least 1 postoperative pain assessment.||percent difference||Standard Deviation|Mean
848520|NCT02077140|Primary|Summed Pain Intensity Over 1- 48hrs (SPI-48)--Sensitivity Analysis Using Last Observation Carried Forward (LOCF)|Similar to SPI-48, the theoretical range for this LOCF adjustment for rescue medication is 0-470, with lower scores indicative of less pain over this time period (i.e., lower scores are consistent with better analgesia). The calculation is identical to SPI-48 in terms of area-under the curve using the trapezoidal rule. However, the NRS score at the final assessment prior to rescue is carried forward through 48 hours, replacing the raw NRS scores post-rescue for each patient as applicable.|over 1 to 48hrs|The primary efficacy analysis was based on the Full Analysis dataset of Cohort 1 to 3. Full Analysis dataset included Safety population (i.e., all subjects who received at least 1 MDT-10013 strip or completed surgery in a standard-of-care group based on the actual treatment a subject received) having at least 1 postoperative pain assessment.||units on a scale||Standard Deviation|Mean
848521|NCT02077140|Primary|Summed Pain Intensity Over 1- 48hrs (SPI-48) From Cohort 1 to 3|Summed pain intensity is a time-weighted average pain score in numeric rating scale (NRS) over 1 to 48hrs (SPI-48). Summed pain intensity is calculated as area under the curve, using the trapezoidal rule to bridge adjacent time points. Specifically, NRS scores for two adjacent time points are averaged and then multiplied by the time span between points (in hours). The theoretical range for SPI-48 is 0 to 470, with lower scores indicative of less pain over this time period (i.e., lower scores are consistent with better analgesia). Time 0 was defined as the time the capsule was closed.|over 1 to 48hrs|The primary efficacy analysis was based on the Full Analysis dataset of Cohort 1 to 3. Full Analysis dataset included Safety population (i.e., all subjects who received at least 1 MDT-10013 strip or completed surgery in a standard-of-care group based on the actual treatment a subject received) having at least 1 postoperative pain assessment.||units on a scale||Standard Deviation|Mean
848522|NCT02049385|Primary|MADRS Change at Day 7|Change in Montgomery Asberg Depression Rating Scale (MADRS) from baseline to 7 days post-treatment. The range of values is from 0 – 60, with a higher score indicating increased depressive symptoms. A score of 7-19 indicates mild depression; 20-34 indicates moderate depression; >34 indicates severe depression.|7 days|The analysis included those subjects who started treatment and completed treatment with Diazoxide or Placebo through at least 7 days.||percentage of change in units of scale||Full Range|Median
848523|NCT02035696|Secondary|Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine|Safety was assessed in terms of number of subjects (6 to <48 months old) reporting unsolicited reactions after Each /any Vaccination from Day 1 [Post Vaccination] to Day 29 [Pre Clinic Visit] and Day 29 [Post Vaccination] to Day 50 [Pre Clinic Visit] , Serious Adverse Events (SAEs), AEs leading to New Onset of Chronic Diseases (NOCD), AEs leading to withdrawal from the study and concomitant medications (day 1 to day 209) after vaccination with two doses of either TIVc or TIVe vaccine (By Any Vaccination)|Unsolicited AEs after Each/any Vaccination from Day 1 to Day 29 and Day 29 to Day 50 , Day 1 to Day 209|Analyses was done on unsolicited safety data set i.e. all subjects in the exposed set who have post-vaccination unsolicited AE data||Subjects|||Number
848524|NCT02035696|Secondary|Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine|Safety was assessed in terms of number of subjects (6 to <48 months old) reporting solicited local and systemic reactions, day 1 to day 7 after vaccination with two doses of either TIVc or TIVe vaccine (By Any Vaccination)|Day 1 to Day 7|Analyses was done on solicited safety data set. 4 subjects (3 subjects from the TIVe group, and 1 subject from the full dose TIVc group, were excluded from the solicited safety set analyses (6h –day3, day4-day7 and 6h – day 7) as these subjects did not provide any post vaccination solicited safety data||Subjects|||Number
848525|NCT02035696|Secondary|Percentages of Subjects (6 to <48 Months Old) Achieving MN Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine|"Immunogenicity was assessed in terms of number (%) of subjects (6 to <48 months old) achieving MN titer ≥1:40 as measured by MN assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine
Post-vaccination MN titer ≥1:40 was defined as for subjects with baseline (day 1) MN titer <1:10, or a minimum 4-fold increase in titer on day 50 for subjects with baseline titer ≥1:10 and corresponding 95% CI"|Day 1 and Day 50 post vaccination|Analysis was done on PPS||Percentages of subjects||95% Confidence Interval|Number
848526|NCT02035696|Secondary|Percentages of Subjects (6 to <48 Months Old) Achieving MN Titer ≥1:20 After Receiving Two Doses of Either TIVc or TIVe Vaccine|"Immunogenicity was assessed in terms of number (%) of subjects (6 to <48 months old) achieving MN titer ≥1:20 as measured by MN assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine
Post-vaccination MN titer ≥1:20 was defined as for subjects with baseline (day 1) MN titer <1:10, or a minimum 2-fold increase in titer on day 50 for subjects with baseline titer ≥1:10 and corresponding 95% CI"|Day 1 and Day 50 post vaccination|Analysis was done on PPS||Percentage of subjects||95% Confidence Interval|Number
848527|NCT02035696|Secondary|Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine|Immunogenicity was assessed in terms of number (%) of subjects (6 to <48 months old) achieving post vaccination HI titers (i.e. HI titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) as measured by HI assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine|Day 1 and Day 50 post vaccination|Analysis was done on PPS||Percentages of subjects||95% Confidence Interval|Number
848528|NCT02035696|Secondary|Geometric Mean Ratios (GMR) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine|Immunogenicity was assessed in terms of GMR in subjects (6 to <48 months old) as measured by MN assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine|Day 50 post vaccination over day 1|Analysis was done on PPS||Ratios||95% Confidence Interval|Number
848529|NCT02035696|Secondary|Geometric Mean Ratios (GMR) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine|"Immunogenicity was assessed in terms of GMR in subjects (6 to <48 months old) as measured by HI assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine
The CHMP criterion is mean geometric ratio (GMR) >2.5"|Day 50 post vaccination over day 1|Analysis was done on FAS||Ratios||95% Confidence Interval|Number
848530|NCT02035696|Secondary|Percentages of Subjects (6 to <48 Months Old) Achieving HI Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine|"Immunogenicity was assessed in terms of number (%) of subjects (6 to <48 months old) achieving HI titer ≥1:40 as measured by HI assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine
The CBER criterion for pediatric population is that the lower bound of the two-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥1:40 should meet or exceed 70%
The CHMP criterion for pediatric population is that the percentage of subjects achieving HI antibody titers ≥1:40 should be >70%"|Day 1, Day 50 post vaccination|Analysis was done on FAS||Percentages of subjects||95% Confidence Interval|Number
848531|NCT02035696|Secondary|Percentages of Subjects (6 to <48 Months Old) Achieving Seroconversion or Significant Increase After Receiving Two Doses of Either TIVc or TIVe Vaccine|"Immunogenicity was assessed in terms of number (%) of subjects (6 to <48 months old) achieving seroconversion as measured by HI assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine
Seroconversion was defined as subjects with either a pre-vaccination (baseline) HI titer < 1:10 and post-vaccination HI titer ≥ 1:40 or with a pre-vaccination HI titer ≥ 1:10 and a ≥ 4-fold increase in post-vaccination HI antibody titer
The Center for Biologics Evaluation, Research, and Review (CBER) criterion for pediatric population is that the lower bound of the two-sided 95% confidence interval (CI) for the percentage of subjects achieving seroconversion for HI antibody should meet or exceed 40%
The Committee for Medicinal Products for Human Use (CHMP) criterion for pediatric population is that the percentage of subjects achieving seroconversion or significant increase in HI antibody titers >40%"|Day 50 post vaccination|Analysis was done on Full analysis set||Percentages of subjects||95% Confidence Interval|Number
848601|NCT01506479|Primary|Percentage of Average Maximum Heart Rate During Exercise as a Measure of Adherence to Exercise|To test whether individuals with de novo Parkinson's disease (naïve to drug treatment) can achieve the randomly assigned levels of mean exercise intensity (60-65% average HRmax or 80-85% average HRmax) and adhere to the exercise protocol.|9 to 26 weeks|Only for participants who contributed heart rate monitor data.||percentage of maximum heart rate||95% Confidence Interval|Mean
848532|NCT02035696|Primary|Desirability Index Score of Subjects (6 to <48 Months Old) Reporting Severe Solicited Local and Systemic Reactions After Vaccination With Either TIVc or TIVe Vaccine|Differences in percentages of subjects (6 to <48 months old) with severe local solicited AEs and severe solicited systemic AEs, 3 days after vaccination with either TIVc or TIVe vaccine was assessed in terms of an individual desirability index score (High dose, Full dose, Half dose TIVc vs. TIVe vaccine). An individual desirability index score was assigned to each (non-transformed) safety value based on predefined functions. Each desirability index score is assigned a value between 0 and 1, wherein 0 is an undesirable response and 1 is a highly desirable response.|Day 1 to Day 3|Analysis was done on PPSd-All subjects in the FASd who:Correctly received the vaccine (i.e., received the vaccine to which the subjects is randomized and at the scheduled time points).||percentage of participants|||Number
848533|NCT02035696|Primary|Percentages of Subjects (6 to <48 Months Old) Achieving Seroconversion or Significant Increase After Receiving Two Doses of Either TIVc or TIVe Vaccine|Immunogenicity was assessed in terms number (%) of subjects (6 to <48 months old) achieving seroconversion as measured by HI antibody titer, day 50 after vaccination with two doses of either TIVc or TIVe vaccine Seroconversion was defined as subjects with either a pre-vaccination (baseline) HI titer < 1:10 and post-vaccination HI titer ≥ 1:40 or with a pre-vaccination HI titer ≥ 1:10 and a ≥ 4-fold increase in post-vaccination HI antibody titer|Day 50 post vaccination|Analysis was done on PP population||Percentages of subjects||95% Confidence Interval|Number
848534|NCT02035696|Primary|Ratios of Geometric Mean Titer (GMT) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine|Immunogenicity was assessed in terms of ratios of GMTs in subjects (6 to <48 months old), measured by hemagglutination inhibition (HI) assay, day 1 to day 50 after vaccination with two doses of either TIVc or TIVe vaccine|Day 50/Day 1|Analysis was done on Per Protocol (PP) population i.e. all subjects in the FAS Efficacy/Immunogenicity Set who are not excluded due to reasons defined prior to unblinding or analysis||Ratios||95% Confidence Interval|Number
848535|NCT01807871|Secondary|Adverse Drug Effects|To test whether the incidence of adverse drug effects during the post-lapse use of nicotine patch is minimal.|Up to 12 weeks|All randomized participants||Participants|||Count of Participants
848536|NCT01807871|Secondary|Mediators of Effect of Post-lapse Nicotine Replacement Therapy Use on Abstinence|To test whether the amount of use of nicotine patch post-lapse, craving, withdrawal, cigs/day, motivation to quit, confidence in quitting, nicotine reinforcement from cigarettes, and self-efficacy mediate any effect of post-lapse patch use on abstinence.|4 months after the quit date|Because the results for the primary outcome were negative, this outcome was not analyzed (i.e., there was no effect to mediate).|||||
848537|NCT01807871|Primary|Point-prevalent Abstinence at 4 Months|"To test our hypothesis that among the subset of the 701 enrolled participants who quit smoking and then lapsed while using the nicotine patch, those randomized to continue the patch post-lapse will be more likely to be 7-day point-prevalent abstinent at 4 month follow-up than those randomized to discontinue the patch post-lapse. 7-day point prevalent abstinence was assessed by response to the question In the last 7 days, on how many days did you smoke on the 4 month follow-up survey. Respondents who replied 0 were classified as Yes for 7-day point-prevalent abstinence; all other responses (including missing) were classified as No."|4 months after the quit date|Participants who lapsed while using the nicotine patch||Participants|||Count of Participants
848538|NCT01683019|Secondary|Safety Profile of the Treatment|Describe the safety profile of the administration of low-emission sinusoidal magnetic fields above the subject's scalp. Safety criteria include adverse events, serious adverse events, and vital signs.|Outcome assessed at the end of the 4th week of treatment.||||||
848539|NCT01683019|Primary|Percent Change in Hamilton Depression Rating Scale (HAMD-17) at Baseline and the End of Week 4 of Treatment.|"Outcome measured using the Hamilton Depression Rating Scale (HAMD-17) and calculated as percent change in severity score from baseline until the end of the 4th week of treatment.
The HAMD-17 scale ranges between 0-54, with higher numbers indicating more severe symptoms. 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates moderate to severe depression."|Assessed at baseline and the end of Week 4 of treatment.|52 subjects were randomized into the study. Of those, 7 dropped in the first week due to difficulties driving to the study site. An intent-to-treat analysis was performed on the remaining 45 subjects.||% change in HAM-D score||Standard Error|Mean
848540|NCT01639040|Other Pre-specified|Percent Change in Eczema Area and Severity Index (EASI) Score From Day 1 (Baseline) to Day 29 (Week 4) - Censored LOCF|EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. The efficacy data were set to missing after prohibited medication was used or after the participant was discontinued from the study. Then, all missing values were imputed by simple LOCF.|Baseline up to Day 29|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline assessment; it was based on the treatment allocated (as randomized).||percent Change||Standard Deviation|Mean
848541|NCT01639040|Other Pre-specified|Percent Change in Investigator's Global Assessment (IGA) Score From Day 1 (Baseline) to Day 29 (Week 4) - Censored LOCF|IGA was an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response was an IGA score of 0 (clear) or 1 (almost clear). The efficacy data were set to missing after prohibited medication was used or after the participant was discontinued from the study. Then, all missing values were imputed by simple LOCF.|Baseline up to Day 29|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline assessment; it was based on the treatment allocated (as randomized).||percent change||Standard Deviation|Mean
848542|NCT01639040|Other Pre-specified|"Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of 0 or 1 at Day 29"|IGA was an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response was an IGA score of 0 (clear) or 1 (almost clear).|Day 29|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline assessment; it was based on the treatment allocated (as randomized).||percentage of participants||95% Confidence Interval|Number
848543|NCT01639040|Other Pre-specified|Percent Change in Pruritus Numerical Rating Scale (NRS) From Day 1 (Baseline) to Day 29 (Week 4)|Pruritus NRS was an assessment tool that was used to report the intensity of participant’s pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 – 10 [0 = no itch; 10 = worst itch imaginable]).|Baseline up to Day 29|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline assessment; it was based on the treatment allocated (as randomized).||percent change||Standard Deviation|Mean
848544|NCT01639040|Other Pre-specified|Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Score: Reduction of ≥50 at Day 29 - Censored Last Observation Carried Forward (LOCF)|The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. The efficacy data were set to missing after prohibited medication was used or after the participant was discontinued from the study. Then, all missing values were imputed by simple LOCF.|Day 29|Full analysis set (FAS) included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline assessment; it was based on the treatment allocated (as randomized).||percentage of participants||95% Confidence Interval|Number
848545|NCT01639040|Primary|Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)|Any untoward medical occurrence in a subject who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on-treatment period (from start of administration of first dose of study drug to the end of study [up to Day 78]). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.|Baseline up to the end of study (up to Day 78)|Safety population included all randomized participants who received any study drug; based on the treatment received (as treated).||percentage of participants|||Number
848546|NCT01612351|Secondary|Number of Subjects Who Experience Adverse Events|Toxicity will be graded using CTCAE criteria.|18 weeks||||||
848547|NCT01612351|Secondary|Voice and Swallowing Function|Assessed by Functional Outcome Swallowing Scale (FOSS) scores, the MD Anderson Dysphagia Inventory (MDADI), the dysphagia-specific quality of life tool (SWAL-QOL), and voice related quality of life tool (V-RQOL), and through videolaryngoscopy evaluation of the aerodigestive tract at screening and 3-5 weeks post induction chemotherapy.|11 weeks||||||
848548|NCT01612351|Secondary|Progression-Free Survival|Progression-free survival associated with 3 part therapy consisting of induction chemotherapy, surgery and risk-adapted use of chemoradiation. Defined as per RECIST criteria. Physical examination, imaging of target lesions by CT scan or MRI and chest imaging (CT or Chest x-ray, if clinically indicated) every 3 months (+/- 30 days) for 18 months following end of treatment|15 years||||||
848549|NCT01612351|Secondary|Overall Survival|Will be defined as per RECIST criteria. Physical examination, imaging of target lesions by CT scan or MRI and chest imaging (CT or Chest x-ray, if clinically indicated) every 3 months (+/- 30 days) for 18 months following end of treatment. Overall survival is measured from the time the patient goes on treatment until death.|15 years||||||
848550|NCT01612351|Secondary|Post Induction Chemotherapy Changes in Risk Level|Risk level pre-induction will be based on physical examination and imaging, post-induction risk level will be determined based on pathologic evaluation or surgical specimen.|11 weeks||||||
848551|NCT01612351|Secondary|Feasibility of 3 Part Therapy|Percentage of patients successfully completing 3 part therapy will be used to assess the feasibility of 3 part therapy consisting of induction chemotherapy, surgery, and risk-adapted use of chemoradiation.|2 years||||||
848552|NCT01612351|Primary|Overall Response Rate|Evaluation of target lesions through tumor imaging (CT scan, MRI, and/or chest x-ray) at 3-5 weeks post induction chemotherapy. Overall response rate will be based on RECIST criteria. Overall response rate (ORR) is defined as the proportion of patients who have a partial or complete response to therapy.|11 weeks|||Participants|||Count of Participants
848553|NCT01610492|Secondary|Urine BLys Levels as a Ratio to Creatinine|B lymphocyte stimulator (BLyS) normalized by creatinine as a ratio of BLyS: creatinine. Free BLyS protein is being analyzed using an ELISA. Urine samples are being collected before treatment and after belimumab washout at Week 0 and Week 116/16 week follow-up visit. Only raw BLyS values available and unable to be assessed due to lack of comparison to a creatinine as a urine concentration marker.|Baseline and Week 116/16 week follow-up visit|ITT Population|||||
848554|NCT01610492|Secondary|Serum BLys Levels|Free BLyS protein were analyzed using an ELISA. Serum samples were collected before treatment and after belimumab washout at Week 0 and Week 116/16 week follow-up visit.|Baseline and Week 116/16 week follow-up visit|ITT Population||pg/mL||Geometric Coefficient of Variation|Geometric Mean
848555|NCT01610492|Secondary|Change From Baseline in Cytokines/Chemokine|Cytokine/chemokine associated with T helper skewing or autoimmune pathology will be analyzed using Luminex, ELISA. Serum analyte quantification were used to confirm altered protein levels of any gene expression increases or decreases identified by transcriptomic analysis. Endpoint was moved to ‘Exploratory’ in Protocol amendment 5 as benefits of assessing cytokines was deemed low. Samples were not analyzed.|Baseline and up to Week 104/4 week post last dose|ITT Population|||||
848577|NCT01610492|Secondary|Serum Albumin Levels at Indicated Time Points|Serum albumin was assessed as a clinical chemistry laboratory parameter from Baseline up to Week 128/6 month follow-up visit. Baseline for serum albumin is defined as the mean of the Screening and Day 0 values. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up.|ITT Population||grams per liter (g/L)||Geometric Coefficient of Variation|Geometric Mean
848556|NCT01610492|Secondary|Change From Baseline in B Cell and T Cell Markers Concentration|B cell Facs panels were used to measure changes over the course of therapy in B cell subsets such as transitional, naïve, memory and plasma B cell compartments by percent of the B cell compartments and absolute numbers. T cell Facs panel were used to measure changes in T cell subsets, such as T regs and CD4+ and CD8+ T cells, in terms of numbers and expression of activation markers to establish if B cell targeting with belimumab affects the T cell compartment perhaps through limiting B cell antigen presentation or cytokine release. Baseline is defined as Day 0 value and change from Baseline was calculated as ratio of post-Baseline value divided by the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and up to Week 128/6 month post last dose|ITT Population||Ratio||Geometric Coefficient of Variation|Geometric Mean
848557|NCT01610492|Secondary|Change From Baseline in Urine Membrane Attack Complex (MAC)|Urine membrane attack complex will be assayed quantitatively by ELISA method. Urine MAC samples are being collected at Day 0 and Weeks 8, 28, 52, 76 and 4 week post last dose. Results will be normalized using urine creatinine concentration to adjust for urine dilution, before calculation of the ratio as value at time point divided by value at Baseline (Day 0). Endpoint was changed to 'exploratory' as risk of availability of functioning assay for urine membrane attack complex was noted. No assay was subsequently found and samples were not analyzed.|Baseline and up to 4 week post last dose|ITT Population|||||
848558|NCT01610492|Secondary|Urine Membrane Attack Complex (MAC) Levels|Urine membrane attack complex was assayed quantitatively by ELISA method. Urine MAC samples were collected at Day 0 and Weeks 8, 28, 52, 76 and 4 week post last dose. Results were normalized using urine creatinine concentration to adjust for urine dilution. Endpoint was moved to ‘Exploratory’ in Protocol amendment 5 as risk of availability of functioning assay for urine membrane attack complex was noted. No assay was subsequently found and samples were not analyzed|Baseline and up to 4 week post last dose|ITT Population|||||
848559|NCT01610492|Secondary|Number of Participants With Positive Immunogenicity Findings|Blood samples of participants were collected pre-dose on Weeks 0, 12, 28, 40, 52, 76, 4 week post last dose and 16 week post last dose visit for belimumab immunogenicity assay. No participants showed positive immunogenicity findings.|Baseline and up to Week 116/16 week follow-up visit|ITT Population||Participants|||Number
848560|NCT01610492|Secondary|Change From Baseline in Temperature|Temperature was measured from Baseline throughout the treatment period up to Week 116/ 16 week follow-up visit. The Baseline value was taken at Day 0 pre dose and change from Baseline was defined as post dose visit value minus Baseline value. Mean and standard deviation (SD) were measured and presented for Week 12, 28, 52, 76, 104 withdrawn visit, 4 Week post last dose and 16 week post last dose visits. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and up to Week 116/16 week follow-up visit|ITT Population||Celsius||Standard Deviation|Mean
848561|NCT01610492|Secondary|Change From Baseline in Pulse Rate|Pulse rate was measured from Baseline throughout the treatment period up to Week 116/ 16 week follow-up visit. The Baseline value was taken at Day 0 pre dose and change from Baseline was defined as post dose visit value minus Baseline value. Mean and standard deviation (SD) were measured and presented for Week 12, 28, 52, 76, 104 withdrawn visit, 4 Week post last dose and 16 Week post last dose visits. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and up to Week 116/16 week follow-up visit|ITT Population||Beats per minute||Standard Deviation|Mean
848562|NCT01610492|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|SBP and DBP were measured from Baseline throughout the treatment period up to Week 116/ 16 week follow-up visit. The Baseline value was taken at Day 0 pre dose and change from Baseline was defined as post dose visit value minus Baseline value. Mean and standard deviation (SD) were measured and presented for Week 12, 28, 52, 76, 104 withdrawn visit, 4 Week post last dose and 16 Week follow-up visit. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and up to week 116/16 week follow-up visit|ITT Population||millimeter of mercury (mmHg)||Standard Deviation|Mean
848563|NCT01610492|Secondary|Number of Participants With Urinalysis Dipstick Findings|Urine samples were collected for urinalysis by dipstick method from Baseline up to Week 116/16 months follow up and number of participants with findings were presented for Baseline, Week 12, 28, 52, 76, 104/4 weeks post last-dose and Week 116/16 week follow up (WF). The urinalysis parameters included occult blood, glucose, ketones, protein. The findings were presented as trace or 1/10 g/100 milliliter (dL), trace, negative, 4+, 3+, 3+ or 1 g/dL, 2+ or 1/2 g/dL, 2+, 1+ or 1/4 g/dL and 1+. Only participants present at the specific time points were presented (represented by n=X in the category titles).|Baseline and up to Week 116/16 Week follow up|ITT Population||Participants|||Number
848564|NCT01610492|Secondary|Number of Participants With Abnormal Clinical Chemistry and Hematology Values|Blood samples were collected from participants for evaluation of clinical chemistry and hematology parameters. The clinical chemistry parameters included albumin, alkaline phosphatase (alk.phosph.), alanine amino transferase (ALT), aspartate amino transferase (AST), total and direct bilirubin, calcium, cholesterol, chloride, carbon dioxide, creatinine, gamma glutamyl transferase (GGT), glucose, potassium, lactate dehydrogenase (LD), magnesium, sodium, phosphorus, total protein, blood urea nitrogen (BUN) and uric acid. The hematology parameters included basophils, eosinophil, hemoglobin, hematocrit, lymphocytes, monocytes, total neutrophils, platelets, red blood cells (RBC) count and white blood cells (WBC) count. Participants were counted in the category that their value changes to (low or high) for the specific time points. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|Baseline and up to Week 116/16 week follow-up visit|ITT Population||Participants|||Number
848565|NCT01610492|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The analysis was performed on Safety Population which comprised of all participants who were randomized into the study. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, Requires hospitalization or prolongation of existing hospitalization, Results in disability/incapacity, is a congenital anomaly/birth defect, may require medical or surgical intervention, is associated with liver injury and impaired liver function.|Baseline and up to Week 128/6 month follow up|ITT Population||Participants|||Number
848566|NCT01610492|Secondary|Change From Baseline in Short Form (SF)-36 v2 Quality of Life (QoL) Questionnaire Score|Health-related quality of life was assessed through participant self-completion of the short form health survey (SF-36 version [v2]), a general health related quality of life metrics. Norm-based Scores (NBS) for physical functioning, role emotional, role physical were assessed. The remaining SF-36 component scores require re-scaling and therefore will be added at a later date. SF-36 was administered prior to any procedures at Weeks 12, 28, 52, 76 and 104/4 week post last dose. Item score were recorded and higher score represented better health status. Baseline is defined as Day 0 pre dose value and change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. Only those participants available at the specified time points were analyzed (represented by n=X in category titles).|Baseline and up to Week 104/4 week post last dose|ITT Population||Scores on a scale||Standard Deviation|Mean
848567|NCT01610492|Secondary|Summary of Total Amount of Urine Excreted Ae(0-24)|PK parameters from the urine concentration data: urine Ae(0-24) were assessed. 24 h urine collections for PK analysis were collected after the Day 0 and Weeks 12, 28, 52, 76 doses and at the 4 week post last dose visit. A population approach was undertaken to characterize the population PK parameters and associated variability of belimumab in nephrotic participants. The population approach could have provided derived clearance of belimumab for each participant after the first dose. The population PK analysis was conducted using nonlinear mixed-effect modeling (NONMEM) or appropriate nonlinear mixed-effect analysis software. Several samples were taken pre-dose at Day 0 and some at week 12 incorrectly which affects interpretation.|Baseline and Up to 4 week post last dose|PK Population||ng/hour||Standard Deviation|Mean
848568|NCT01610492|Secondary|Summary of Area Under the Serum Concentration-time Curve to the Last Quantifiable Concentration (AUC[0-2])|The AUC(0-2) was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. Blood samples for PK analysis were collected at the following time points: pre-dose (on dosing days): Days 0, 1, 4, 7, 14 and Week 4, 8, 12, 28, 40, 52, 76 and 4 week post last dose. Post-dose (5 minutes after dosing complete): Days 0 and 28. The results will be posted at later date following post hoc analysis.|Baseline and up to 4 week post last dose|PK Population|||||
848569|NCT01610492|Secondary|Summary of Minimum Observed Concentration (Cmin) of Belimumab at the Indicated Time Points|Trough concentration (Cmin) samples collected on the specified days are being used to assess attainment whether there was sufficient belimumab despite it being lost in the urine from the proteinuria and to check if it improved as proteinuria resolved. Analysis was performed on pre-infusion samples at weeks 2,4,8,12,28,40,52,76 and the 4 week post last-dose.|Baseline and up to 4 week post last dose|PK Population||ng/mL||Standard Deviation|Mean
848570|NCT01610492|Secondary|Summary of Maximum Observed Serum Concentration (Cmax) of Belimumab at the Indicated Time Points|The first occurrence of Cmax was determined directly from the serum concentration-time data. The pharmacokinetic (PK) parameters were calculated by standard non-compartmental analysis and all calculations of non-compartmental parameters are being based on actual sampling times.|Baseline and up to 4 week post last dose|PK Population: all participants in the ITT Population for whom a PK sample was obtained and analyzed.||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
848571|NCT01610492|Secondary|Number of Participants With Edema and Edema Extending Beyond Calf|Reduction of proteinuria lessens the risk of thromboembolic and cardiovascular effects and reduces the edema in participants. Investigators physically reviewed participants for clinical manifestations of idiopathic membranous glomerulonephropathy (IMGN) (e.g. edema extending beyond calf) during study and analysis was performed at Week 12, 28, 52, 76 Week 104. Only those participants available at the specified time points were analyzed (represented by n=X in category titles).|Baseline and Weeks 12, 28, 52, 76, and 104|ITT Population||Participants|||Number
848572|NCT01610492|Secondary|Change From Baseline in Serum IgG at the Indicated Time Points|Serum IgG was assessed as a clinical chemistry laboratory parameter from Baseline up to Week 128/6 month follow-up visit. Baseline for serum IgG is defined as the pre-dose Day 0 value and change from Baseline was calculated as ratio of post-Baseline value divided by the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow up|ITT Population||Ratio||Standard Deviation|Mean
848573|NCT01610492|Secondary|Serum Immunoglobulin G (IgG) Levels at Indicated Time Points|Serum IgG was assessed as a clinical chemistry laboratory parameter from Baseline up to Week 128/6 month follow-up visit. Baseline for serum IgG is defined as the pre-dose Day 0 value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up|ITT Population||g/L||Standard Deviation|Mean
848574|NCT01610492|Secondary|Change From Baseline in Serum Cholesterol at the Indicated Time Points|Serum cholesterol was assessed as a clinical chemistry laboratory parameter from Baseline up to Week 128/6 month follow-up visit. Baseline for serum cholesterol is defined as the mean of the Screening and Day 0 values and change from Baseline was calculated as ratio of post-Baseline value divided by the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up|ITT Population||mmol/L||Geometric Coefficient of Variation|Geometric Mean
848575|NCT01610492|Secondary|Serum Cholesterol Levels at Indicated Time Points|Serum cholesterol was assessed as a clinical chemistry laboratory parameter from Baseline up to Week 128/6 month follow-up visit. Baseline for serum cholesterol is defined as the mean of the Screening and Day 0 values. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up|ITT Population||millimoles per liter (mmol/L)||Geometric Coefficient of Variation|Geometric Mean
848576|NCT01610492|Secondary|Change From Baseline in Levels of Serum Albumin at the Indicated Time Points|Serum albumin was assessed as a clinical chemistry laboratory parameter from Baseline up to Week 128/6 month follow-up visit. Baseline for serum albumin is defined as the mean of the Screening and Day 0 values and change from Baseline was calculated as ratio of post-Baseline value divided by the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up|ITT Population||ratio||Geometric Coefficient of Variation|Geometric Mean
854468|NCT00923351|Primary|Toxicity|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|49.5 months|||Participants|||Count of Participants
848578|NCT01610492|Secondary|Change From Baseline in Serum Creatinine Levels at the Indicated Time Points|Serum creatinine was assessed as a clinical chemistry laboratory parameter from Baseline up to Week 128/6 month follow-up visit. Baseline for serum creatinine is defined as the mean of the Screening and Day 0 values and change from Baseline was calculated as ratio of post-Baseline value divided by the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up|ITT Population||Ratio||Geometric Coefficient of Variation|Geometric Mean
848579|NCT01610492|Secondary|Serum Creatinine Levels at the Indicated Time Points|Serum creatinine was assessed as a clinical chemistry laboratory parameter from Baseline up to Week 128/6 month follow-up visit. Baseline for serum creatinine is defined as the mean of the Screening and Day 0 values. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up|ITT Population||micromoles/liter (µmol/L)||Geometric Coefficient of Variation|Geometric Mean
848580|NCT01610492|Secondary|Change From Baseline in eGFR Levels at the Indicated Time Points|eGFR was assessed from levels of creatinine using the 4 variable version of the modification of diet in renal disease (MDRD) equation as recommended by national kidney foundation-chronic kidney disease (NKF-CKD) guidelines. Baseline for eGFR is defined as the mean of the Screening and Day 0 values and change from Baseline was calculated as ratio of post-Baseline value divided by the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and up to Week 128/6 month follow up|ITT Population||Ratio||Geometric Coefficient of Variation|Geometric Mean
848581|NCT01610492|Secondary|eGFR Levels at the Indicated Time Points|eGFR was assessed from levels of creatinine using the 4 variable version of the modification of diet in renal disease (MDRD) equation as recommended by National Kidney Foundation-Chronic Kidney Disease (NKF-CKD) guidelines. Baseline for eGFR is defined as the mean of the screening and Day 0 values. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up.|ITT Population||milliliter/minute (mL/min/1.73meter^2)||Geometric Coefficient of Variation|Geometric Mean
848582|NCT01610492|Secondary|Number of Participants With Anti-PLA2R Autoantibody Relapse|Incidence of anti-PLA2R autoantibody relapse defined as antibody detectable after previously undetectable. Anti-PLA2R autoantibody blood samples were evaluated at Week 12, 28, 52, 76, 104/4 week post last dose, Only those participants available at the specified time points were analyzed (represented by n=X in category titles).|Baseline and up to Week 128/6 month follow up|ITT Population||Participants|||Number
848583|NCT01610492|Secondary|Time to Anti-PLA2R Autoantibody Remission|Time to anti-PLA2R autoantibody remission was estimated using Kaplan-Meier method for full response and partial response full response with antibody undetectable and partial response with reduction in titers by 50 percent.|Baseline and up to Week 128/6 month follow up|ITT Population||Weeks||95% Confidence Interval|Median
848584|NCT01610492|Secondary|Number of Participants With PLA2R Autoantibody Remission|Incidence of anti-PLA2R autoantibody remission were evaluated by full response and partial response. Full response is defined as antibody undetectable, partial response is defined as reduction in titers by 50 percent. For anti PLA2R autoantibody data, log transformation was applied before the formal analyses. Anti-PLA2R autoantibody blood samples were evaluated at Week 12, 28, 52, 76, 104 and 128/6 week post last-dose. Only those participants available at the specified time points were analyzed (represented by n=X in category titles).|Baseline and Weeks 12, 28, 52, 76, 104 and 128|ITT Population||Participants|||Number
848585|NCT01610492|Secondary|Duration of Complete or Partial Remission|Complete remission is defined as PCR <30 mg/mmol (proteinuria <0.3g/24 h) with no worsening in renal function (eGFR reduction from Baseline <15percent). Partial remission is defined as PCR <350 mg/mmol (proteinuria <3.5 g/24 h) but >= 30 mg/mmol (proteinuria >= 0.3g/24h) and decrease of >50% from Day 0 Baseline, together with no consistent worsening in renal function (eGFR reduction from Baseline <15percent). Only those participants available at the specified time points were analyzed (represented by n=X in category titles). NA indicates that data was not available as only 1 participant reached complete remission. Hence, standard deviation for complete remission was not calculated.|Baseline and up to Week 128/6 month follow up|ITT Population||Days||Standard Deviation|Mean
848586|NCT01610492|Secondary|Time to Complete or Partial Remission|Time to complete or partial remission was estimated using the Kaplan-Meier method. Complete remission is defined as PCR <30 mg/mmol (proteinuria <0.3g/24 h) with no worsening in renal function (eGFR reduction from Baseline <15 percent ). Partial remission is defined as PCR <350 mg/mmol (proteinuria <3.5 g/24 h) but >= 30 mg/mmol (proteinuria >= 0.3g/24h) and decrease of >50 percent from Day 0 Baseline, together with no consistent worsening in renal function (eGFR reduction from Baseline <15 percent). Only 1 participant reached complete remission. Hence, statistical analysis for complete remission was not performed.|Baseline and up to Week 128/6 month follow up|ITT Population||Weeks||95% Confidence Interval|Median
848587|NCT01610492|Secondary|Number of Participants With Complete or Partial Remission|Complete remission is defined as PCR <30 mg/mmol (proteinuria <0.3grams [g]/24 h) with no worsening in renal function (estimated glomerular filtration rate [eGFR] reduction from Baseline <15 percent). Partial remission is defined as PCR <350 mg/mmol (proteinuria <3.5 g/24 h) but >= 30 mg/mmol (proteinuria >= 0.3g/24h) and decrease of >50 percent from Day 0 Baseline, together with no consistent worsening in renal function (eGFR reduction from Baseline <15percent). Only those participants available at the specified time points were analyzed (represented by n=X in category titles).|Baseline and Weeks 12, 28, 52, 76, 104 and 128|ITT Population||Participants|||Number
848588|NCT01610492|Secondary|Change From Baseline in Anti-PLA2R Autoantibody Titers at the Indicated Time Points|Anti-PLA2R autoantibody titers in serum were analyzed by means of a validated anti- PLA2R enzyme linked immunosorbent assay (ELISA) from Euroimmun. Baseline is defined as the Day 0 value and change from Baseline was calculated as ratio of post-Baseline value divided by the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and Weeks 12, 28, 52, 76, 104 and 128.|ITT Population||Ratio||Geometric Coefficient of Variation|Geometric Mean
848716|NCT00602836|Secondary|Time to Disease Progression (TTP)|Time to disease progression (TTP) was defined as the time from registration to the earliest date documentation of disease progression. Participants were followed for a maximum of 5 years from registration. The median TTP with 95% CI was estimated using the Kaplan Meier method.|time from registration to progression (up to 5 years)||||||
848589|NCT01610492|Secondary|Anti-phospholipase A2 Receptor (PLA2R) Autoantibody Levels at Indicated Time Points|Anti-PLA2R autoantibody titers in serum were analyzed by means of a validated anti-PLA2R enzyme linked immunosorbent assay (ELISA) assay from Euroimmun. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and Week 12, 28, 52, 76, 104 and 128/6 month follow-up|ITT Population.||relative units per milliliter (RU/mL)||Geometric Coefficient of Variation|Geometric Mean
848590|NCT01610492|Secondary|Change From Baseline in Proteinuria Levels at the Indicated Time Points|Proteinuria based on urinary protein creatinine ratio (PCR) measured from 2 consecutive 24h urine collections at Baseline and Week 28, from a pre-intervention spot urine sample and 24 hour urine collection after visit at Weeks 12, 52, 76 and 104, and from a spot urine sample at week 128. Mean PCR was calculated at each time point where there were 2 samples. Baseline is defined as Day 0 value and change from Baseline was calculated as ratio of post-Baseline value divided by the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and Week 12, 28, 52, 76, 104 and Week 128/6 month follow up|ITT Population.||Ratio||Geometric Coefficient of Variation|Geometric Mean
848591|NCT01610492|Secondary|Proteinuria Levels at the Indicated Time Points|Proteinuria based on urinary protein creatinine ratio (PCR) measured from 2 consecutive 24h urine collections at Baseline and Week 28, from a pre-intervention spot urine sample and 24 hour urine collection after visit at Weeks 12, 52, 76 and 104, and from a spot urine sample at week 128. Mean PCR was calculated at each time point where there were 2 samples. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and Week 12, 28, 52, 76, 104 and 128/6 month follow-up|ITT Population||milligrams per millimole (mg/mmol)||Geometric Coefficient of Variation|Geometric Mean
848592|NCT01610492|Primary|Change From Baseline in Anti-phospholipase A2 Receptor (PLA2R) Autoantibody Titers at Week 28|PLA2R autoantibody titers in serum were analyzed at Baseline and Week 28 by means of a validated anti- PLA2R enzyme linked immunosorbent assay (ELISA) from EuroImmun. Baseline is defined as the Day 0 value and change from Baseline was calculated as ratio to Baseline by dividing the Week 28 values with the Baseline values. Ratio to Baseline: Estimated value = 0.27, 2-sided 95% CI=0.12 to 0.58. The geometric mean method was used to calculate the CI.|Baseline and Week 28|ITT Population. Only those participants available at the indicated time point (Week 28) were analyzed.||Ratio||Geometric Coefficient of Variation|Geometric Mean
848593|NCT01610492|Primary|Change From Baseline in Proteinuria Levels at Week 28|Proteinuria based on urinary protein creatinine ratio (PCR) was measured from 2 consecutive 24 hour (h) urine collection pre and post dosing at Baseline and Week 28 and the mean PCR was determined at each time point. Baseline is defined as the mean of the pre and post dosing Day 0 values. The ratio is defined as the Week 28 value divided by the Baseline value. Ratio to Baseline: Estimated value = 0.76, 2-sided 95% confidence interval (CI)=0.57 to 1.01. The geometric mean method was used to calculate the CI. The analysis was performed on Intent-to-treat (ITT) Population which comprised of all eligible participants who received at least one dose of investigational drug. Only those participants available at the indicated time point (Week 28) were analyzed.|Baseline and Week 28|Intent-to-Treat (ITT) Population||Ratio||Geometric Coefficient of Variation|Geometric Mean
848594|NCT01575106|Primary|fMRI Signal Changes in the Dorsal Anterior Cingulate Cortex|We used fMRI to investigate the signal changes associated with administration of identical pain stimuli before (pre) and after the treatment (post) with different creams in session 3. It is important to note that the subjects had multiple weeks to complete the study, but this measure was only taken during one session. The change was calculated from two time points as the value at the later time point (post treatment) minus the value at the earlier time point (pre treatment).|Week 4|The neutral cream is omitted from the data table below because we were only concerned about the direct comparison between positive expectancy (“Lidocaine”) and negative expectancy (“Capsaicin”) conditions. Data were only collected for the Lidocaine and Capsaicin creams.||Post-Pre treatment peak beta||Standard Deviation|Mean
848595|NCT01575106|Primary|Subjective Response to Pain (0-20 Visual Analogue Scale)|Subjects received heat pain before and after the application of a neutral cream (told one application of neutral cream was lidocaine, one was capsaicin, and one was neutral) and rated pain intensity on a 0-20 Visual Analogue Scale (0-no pain, 20-intolerable pain). We only measure this outcome measure in session 3. The pain intensity for each cream was averaged amongst all participants for both the pre and post treatment in session 3. Subjects have up to 3 weeks to complete the 3 sessions.|Weeks 1-3|||units on a scale||Standard Error|Mean
848596|NCT01539759|Secondary|Women's Satisfaction With IUDs||0-6 months postpartum|||percentage of participants satisfied|||Number
848597|NCT01539759|Secondary|IUD Expulsion||0-6 months postpartum|||participants|||Number
848598|NCT01539759|Primary|IUD Use|The use of an IUD at 6 months postpartum is the primary outcome measure|6 months postpartum|||participants|||Number
848599|NCT01506479|Other Pre-specified|Number of Days of Exercise Per Week|The number of days the participant exercised per week|9 to 26 weeks|Participants were analyzed in the group to which they were assigned. Participants were not included if they did not start the intervention.||Number of days per week||95% Confidence Interval|Mean
848600|NCT01506479|Secondary|6 Month Change in Unified Parkinson's Disease Rating Scale (UPDRS) Motor Score|Participants were assessed at baseline and at 6 months on their UPDRS. If a participant initiated Parkinson disease medication prior to the 6 month assessment, the UPDRS score from the clinical visit assessment prior to this initiation was used as the score for the individual at 6 months. The change in the UPDRS motor score at 6 months was used as the measure for the futility component of the trial. The change at 6 months was measured as the 6 month value minus the baseline score. A positive change represents worsening of motor symptoms; 0 represents no change; negative values represent improvement. The minimum score on the UPDRS motor is 0 and the maximum is 108 at baseline and 6 months with higher scores representing worse motor symptoms.|Baseline and 6 months|Intention to treat; participants were analyzed in the group to which they were assigned. If a participant started medication, the UPDRS measure prior to initiating medication was used even if the 6 month data were not collected. Participants who did not start medications and were missing the 6 month assessment were not included.||units on the UPDRS Motor scale||95% Confidence Interval|Mean
848717|NCT00602836|Secondary|Overall Survival (OS)|Overall Survival (OS) was defined as the time from registration to death of any cause. Participants were followed for a maximum of 5 years from registration. The median OS with 95% CI was estimated using the Kaplan Meier method.|time from registration to death (up to 5 years)||||||
848602|NCT01262898|Secondary|Change From Baseline in Whole Bowel Transit Time, 100 % Gastric Emptying Time (Truncated at 240 Minutes), Small Bowel Transit Time, Colonic Transit Time as Determined by Wireless Motility Capsule (WMC)|WMC is an ingestible telemetric capsule which measures pH, pressure and temperature to assess total gastric emptying time, small and large bowel transit time, colonic transit time, and whole gut transit time. The WMC was ingested immediately following the standard test meal for the oral breath test. Data was collected on a data logger, which was worn on a belt clip. The WMC passed naturally in the participant’s stools between 2 and 5 days after ingestion. The parameters Whole bowel transit time, 100 % gastric emptying time (truncated at 240 minutes), small bowel transit time, colonic transit time were analyzed. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline(Screening i.e., Day -30 to -1), Day 1 and 28|All Subjects Population. Only those participants available at specified time points were analyzed.||minutes||Standard Deviation|Mean
848603|NCT01262898|Secondary|Change From Baseline in Upper Gastrointestinal (GI) Symptoms as Assessed by Total Gastrointestinal Cardinal Symptom Index – Daily Diary (GCSI–DD)|GCSI–DD was measured on a 6-point scale. The Total GCSI-DD score was the mean of the following three subscales: Nausea/Vomiting Subscale = mean (nausea, retching, vomiting), Fullness/Early Satiety Subscale = mean (feeling excessively full after meals, not able to finish a normal-sized meal, stomach fullness, loss of appetite), Bloating Subscale = mean (bloating, stomach or belly visibly larger). Each subscale was scored on a severity scale of 0 (none) to 5 (very severe), with lower scores representing less symptom severity. The change from Baseline to each study week in average score was derived and if it improved by 1 point or more, that participant was defined as “responder” for that symptom and on that particular week. Baseline was Screening2/Baseline values (Day -30 to -1). Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Up to 14 days post last dose (Day 28)|All Subjects Population. Only those participants available at specified time points were analyzed.||Score on a scale||Standard Deviation|Mean
848604|NCT01262898|Secondary|Daily Average Stool Consistency|Stool consistency was determined on a scale of 1 to 5 (1 = Very hard, 2 = Hard, 3 = Formed, 4 = Loose, 5 = Watery). Following dosing with study medication, stool monitoring was performed up to Day 28. Participants who entered their time of first instance of bowel movement before taking first dose were excluded from the summary statistics.|Up to Week 4 (Day 28)|All Subjects Population. Only those participants available at specified time points were analyzed.||Bowel Movements/ 24 hours||Standard Deviation|Mean
848605|NCT01262898|Secondary|Daily Bowel Movement Frequency|Daily bowel movement frequency analyzed number of times passed stools in 24 hours of duration. Following dosing with study medication, stool monitoring was performed up to Day 28. Seventeen participants who entered their time of first instance of bowel movement before taking first dose were excluded from the summary statistics.|Up to Week 4 (Day 28)|All Subjects Population. Only those participants available at specified time points were analyzed.||Bowel movements/24 hours||Standard Deviation|Mean
848606|NCT01262898|Secondary|Time to First Bowel Movement After First Dose|The time to first bowel movement was calculated as the time of the first bowel movement after the first dose in hours (floored) for each participant. If a participant had fewer than 5 days worth of data then the daily mean for that week was set to missing for the following two parameters: Bowel Movement Count and Stool Consistency. Seventeen participants who entered their time of first instance of bowel movement before taking first dose were excluded from the summary statistics of time to first bowel movement.|Up to Day 28|All Subjects Population. Only those participants available at specified time points were analyzed.||hours||Standard Deviation|Mean
848607|NCT01262898|Secondary|Apparent Terminal Elimination Half-life (t1/2) at Specified Time Points|This outcome measure was not analyzed in results.|Pre-dose and 1.5, 2.5, 3.5, 4.5, and 5.5 hours post dose on Day 1 and 28||||||
848608|NCT01262898|Secondary|Apparent Volume of Distribution (V/F) at Specified Time Points|The apparent volume of distribution V/F = CL/F × MRT, where MRT is the mean residence time. The parameter was planned to be analyzed using samples collected at Pre-dose and 1.5, 2.5, 3.5, 4.5, and 5.5 hours post dose on Day 1 and 28. But, this outcome measure was not analyzed in results.|Pre-dose and 1.5, 2.5, 3.5, 4.5, and 5.5 hours post dose on Day 1 and 28||||||
848609|NCT01262898|Secondary|Apparent Clearance Following Oral Dosing (CL/F) at Specified Time Points|CL/F was calculated as dose/AUC. The parameter was planned to be analyzed from samples collected at Pre -dose and 1.5, 2.5, 3.5, 4.5, and 5.5 hours post dose on Day 1 and 28.This outcome measure was not analyzed in results.|Pre-dose and 1.5, 2.5, 3.5, 4.5, and 5.5 hours post dose on Day 1 and 28||||||
848610|NCT01262898|Secondary|Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ct) at Specified Time Points|Analysis of pre-dose (trough) concentration at the end of the dosing interval (Ct) was planned to be performed from the samples collected at Pre -dose and 1.5, 2.5, 3.5, 4.5, and 5.5 hours post dose on Day 1 and 28.|Pre-dose and 1.5, 2.5, 3.5, 4.5, and 5.5 hours post dose on Day 1 and 28|PK population.||Liters||Standard Deviation|Mean
848611|NCT01262898|Secondary|Time of Occurrence of Cmax (Tmax) at Specified Time Points|Tmax is defined as the time to reach the observed maximum concentration. Samples were collected at the following times: Tmax was determined directly from the raw concentration-time data. Pre-dose and 1.5, 2.5, 3.5, 4.5, and 5.5 hours post dose.|Pre-dose and 1.5, 2.5, 3.5, 4.5, and 5.5 hours post dose on Day 1 and 28|PK population. Only those participants available at specified time points were analyzed.||Hour||Standard Deviation|Mean
848612|NCT01262898|Secondary|Maximum Observed Concentration (Cmax) at Specified Time Points|Cmax is defined as the maximum observed drug concentration after administration. Cmax was determined directly from the raw concentration-time data. Samples were collected at the following times: Pre-dose and 1.5, 2.5, 3.5, 4.5, and 5.5 hours post dose.|Pre-dose and 1.5, 2.5, 3.5, 4.5, and 5.5 hours post dose on Day 1 and 28|PK population. Only those participants available at specified time points were analyzed.||Nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
848625|NCT01262898|Secondary|Number of Participants Outside the Normal Range for Heart Rate|Heart rate measurements were taken at pre-dose and at 120 min (completion of meal) on Day 1 and Day 28. The CCR for heart rate was Increase or decrease by less than or equal to (>=) 15 and >= 30. Data for semi-supine position has been presented. Baseline was Screening2/Baseline values.|Screening2/Baseline (Day -30 to -1), Day 1 and 28|All Subjects Population. Only those participants available at specified time points were analyzed.||Participants|||Number
848718|NCT00602836|Secondary|Number of Participants With a Response (CR, nPR, PR)|Response criteria described in above outcomes|During treatment (up to 5 years)||||||
848613|NCT01262898|Secondary|Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration AUC(0-t) at Specified Time Points|AUC(0-t) was derived from GSK962040 plasma concentration-time data. AUC was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations.Only participants who received GSK962040 drug were analyzed.|Pre-dose and 1.5, 2.5, 3.5, 4.5, and 5.5 hours post dose on Day 1 and 28|The ‘PK Population' was defined as participants in the ‘All subjects’ population for whom a pharmacokinetic sample was obtained and analyzed. Only those participants available at specified time points were analyzed.||Nanograms.hour/milliliter (ng.h/mL)||Geometric Coefficient of Variation|Geometric Mean
848614|NCT01262898|Secondary|Mean Change From Baseline in Hematology Parameters : Red Blood Cell Count, Reticulocytes|Red Blood Cell count, Reticulocytes measurements were taken at Baseline (Day 1 pre-dose) and Day 28. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline (Day 1 pre-dose) and Day 28|All Subjects Population. Only those participants available at specified time points were analyzed.||Tera (10^12) cells per liter (TI/L)||Standard Deviation|Mean
848615|NCT01262898|Secondary|Mean Change From Baseline in Hematology Parameters : Mean Corpuscle Volume|Mean Corpuscle Volume measurements were taken at Baseline (Day 1 pre-dose) and Day 28. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline (Day 1 pre-dose) and Day 28|All Subjects Population. Only those participants available at specified time points were analyzed.||Femtoliters (FL)||Standard Deviation|Mean
848616|NCT01262898|Secondary|Mean Change From Baseline in Hematology Parameters : Hemoglobin, Mean Corpuscle Hemoglobin Concentration|Hemoglobin, Mean Corpuscle Hemoglobin concentration measurements were taken at Baseline (Day 1 pre-dose) and Day 28. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline (Day 1 pre-dose) and Day 28|All Subjects Population. Only those participants available at specified time points were analyzed.||g/L||Standard Deviation|Mean
848617|NCT01262898|Secondary|Mean Change From Baseline in Hematology Parameters : Mean Corpuscle Hemoglobin|Mean Corpuscle Hemoglobin measurements were taken at Baseline (Day 1 pre-dose) and Day 28. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline (Day 1 pre-dose) and Day 28|All Subjects Population. Only those participants available at specified time points were analyzed.||Picograms (Pg)||Standard Deviation|Mean
848618|NCT01262898|Secondary|Mean Change From Baseline in Hematology Parameters : Hematocrit|Hematocrit measurements were taken at Baseline (Day 1 pre-dose) and Day 28. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline (Day 1 pre-dose) and Day 28|All Subjects Population. Only those participants available at specified time points were analyzed.||Ratio||Standard Deviation|Mean
848619|NCT01262898|Secondary|Mean Change From Baseline in Hematology Parameters : Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total ANC - Total Absolute Neutrophil Count), Platelet Count, White Blood Cell Count|Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total ANC - Total Absolute Neutrophil Count), Platelet count, White Blood cell count measurements were taken at Baseline (Day 1 pre-dose) and Day 28. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline (Day 1 pre-dose) and Day 28|All Subjects Population. Only those participants available at specified time points were analyzed.||Giga (10^9) cells per liter (GI/L)||Standard Deviation|Mean
848620|NCT01262898|Secondary|Mean Change From Baseline in Clinical Chemistry : Calcium, Chloride, Glucose, Potassium, Sodium, Urea/BUN, Carbon Dioxide Content/Bicarbonate|Calcium, Chloride, Glucose, Potassium, Sodium, Urea/BUN, Carbon dioxide content/Bicarbonate measurements were taken at Baseline (Day 1 pre-dose) and Day 28. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline (Day 1 pre-dose) and Day 28|All Subjects Population. Only those participants available at specified time points were analyzed.||Millimoles per liter (MMOL/L)||Standard Deviation|Mean
848621|NCT01262898|Secondary|Mean Change From Baseline in Clinical Chemistry : Albumin, Total Protein|Albumin, Total Protein measurements were taken at Baseline (Day 1 pre-dose), and Day 28. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline (Day 1 pre-dose) and Day 28|All Subjects Population. Only those participants available at specified time points were analyzed.||Grams per liter (g/L)||Standard Deviation|Mean
848622|NCT01262898|Secondary|Mean Change From Baseline in Clinical Chemistry: Direct Bilirubin, Total Bilirubin, Creatinine, Uric Acid|Direct Bilirubin, Total Bilirubin, Creatinine, Uric acid measurements were taken at Baseline (Day 1 pre-dose), Day 5, 10, 14, 21 and 28. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline (Day 1 pre-dose), Day 5, 10, 14, 21 and 28|All Subjects Population. Only those participants available at specified time points were analyzed.||Unit moles per litre (UMOL/L)||Standard Deviation|Mean
848623|NCT01262898|Secondary|Mean Change From Baseline in Clinical Chemistry: Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Gamma Glutamyl Transferase, Creatine Kinase, Lactate Dehydrogenase|Alkaline phosphatase, alanine amino transferase, aspartate amino transferase, gamma glutamyl transferase, creatine kinase, lactate dehydrogenase measurements were taken at Baseline (Day 1 pre-dose), Day 5, 10, 14, 21 and 28. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline (Day 1 pre-dose), Day 5, 10, 14, 21 and 28|All Subjects Population. Only those participants available at specified time points were analyzed.||International units per liter (IU/L)||Standard Deviation|Mean
848624|NCT01262898|Secondary|Number of Participants Outside the Normal Range for 12-lead ECG|ECG measurements were taken at pre-dose and 0 min (completion of meal) on Day 1 and Day 28. The CCR for ECG parameters were: PR interval (<110 and >220), QRS interval (<75 and >110), Absolute QTc interval (>450 to =< 480) respectively. Baseline was the pre-dose reading for Day 1. Data for abnormal- clinically significant (ACS) and abnormal- not clinically significant (ANCS) has been presented.|Baseline (Day 1 pre-dose), Day 1, Day 14 and Day 28|All Subjects Population. Only those participants available at specified time points were analyzed.||Participants|||Number
848626|NCT01262898|Secondary|Number of Participants Outside the Normal Range for SBP and DBP|Blood pressure measurements were taken at pre-dose and at 120 min (completion of meal) on Day 1 and Day 28. The clinical concern range (CCR) for SBP was greater than (<) 85 and less than (>) 160 and for DBP the range was <45 and >100. Data for semi-supine position has been presented. Baseline was Screening2/Baseline values.|Screening2/Baseline (Day -30 to -1), Day 1 and 28|All Subjects Population. Only those participants available at specified time points were analyzed.||Participants|||Number
848627|NCT01262898|Secondary|Change From Baseline in Electrocardiography Parameters (12-lead ECG)|ECG measurements were taken at pre-dose and 0 min (completion of meal) on Day 1 and Day 28. The Baseline value was the Day 1 pre-dose value. ECG parameters included PR interval, QRS duration, QT interval, QTcB, QTcF and RR interval.|Baseline, Day 1 and Day 28|All Subjects Population. Only those participants available at specified time points were analyzed.||Milliseconds (msec)||Standard Deviation|Mean
848628|NCT01262898|Secondary|Change From Baseline in Heart Rate at Specified Time Points in Semi-supine Position|Heart rate measurements were taken at pre-dose and 120 min (completion of meal) on Day 1 and Day 28. The Baseline value was Day 1 Pre-Dose values . Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline, Day 1, and Day 8|All Subjects Population. Only those participants available at specified time points were analyzed.||Beats per minute (BPM)||Standard Deviation|Mean
848629|NCT01262898|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure(DBP) at Specified Time Points in Semi-supine Position|Blood pressure measurements were taken at pre-dose and at 120 min (completion of meal) on Day 1 and Day 28. The Baseline value was Day 1 Pre-Dose values. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline, Day 1, and Day 8|All Subjects Population. Only those participants available at specified time points were analyzed.||Millimeters of mercury (mmHg)||Standard Deviation|Mean
848630|NCT01262898|Secondary|Number of Participants With On-treatment Adverse Events (AES) and Serious Adverse Events(SAEs)|An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. An SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Data for on-treatment adverse events is reported.|Up to follow-up (5-10 days post last dose)|All Subjects population.||Participants|||Number
848631|NCT01262898|Primary|Gastric Half Emptying Time (GEt1/2)|Gastric half emptying time is the time taken for half the contents of the stomach to empty. Gastric emptying was measured using the 13C-oral breath test, which is a tracer method that utilizes 13C, a non-radioactive isotope. Basal breath samples were obtained after an overnight fast or otherwise after 4 hours of fasting following a light meal. On Day 1 and Day 28, participants were then dosed with GSK962040 and additional breath test samples were taken prior to administration of a 13C-labelled test meal. The test meal was consumed approximately 80 minutes(min) later. After consumption of the test meal, breath samples were collected at pre-specified time points over an approximately 4 hour period following the test meal. For the duration of the breath test, no food or drink were allowed. The 13C breath content was determined by isotope ratio mass spectrometry. GE t1/2 was determined by using the cumulative percentage of the administered dose of 13C excreted in breath over 4 hours.|Screening2/Baseline (Day -30 to -1) , Day 1, and Day 28|The ‘All Subjects Population’ compromised of all participants who received at least one dose of study medication. Only those participants available at specified time points were analyzed.||Minutes||Standard Deviation|Mean
848632|NCT01257750|Secondary|Corneal Vessel Length|Change in Vessel Length: defined as the mean measurement of the extent of vessels from end to end.|12 Weeks||||||
848633|NCT01257750|Secondary|Corneal Invasion Area|Change in invasion area: measuring the fraction of the total corneal area invaded by the vessels.|12 Weeks||||||
848634|NCT01257750|Secondary|Corneal Vessel Caliber|Change in vessel caliber: measuring the mean diameter of the corneal vessels.|12 Weeks||||||
848635|NCT01257750|Primary|Non-Ocular (Systemic) Adverse Events|Incidence and severity of other adverse events, as identified by physical examination, subject reporting, and changes in vital signs (blood pressure and heart rate) through week 12|12 Weeks|All enrolled patients were analyzed.||participants|||Number
848636|NCT01257750|Secondary|Corneal Neovascular Area|Changes in neovascular area: measuring the area of the corneal vessels.|Through 12 weeks of Follow-Up||||||
848637|NCT01257750|Primary|Ocular Adverse Events|Incidence and severity of ocular adverse events, as identified by eye examination and visual acuity testing through week 12|12 Weeks of follow-up|All enrolled patients were analyzed.||participants|||Number
848638|NCT01256840|Primary|Telomere Length|This study is not a clinical trial, but the UCSF Committee on Human Research requires registration with clinicaltrials.gov. It is a ONE TIME POINT study, where we get a simple blood draw from people from three groups - calorie restricting, normal eating, and obese. Therefore, there IS NO FOLLOW UP/time frame. The outcome measure is assessed on the day of the study. Telomere length is a marker of cellular aging and is used to understand how the cells are aging. We will investigate whether long-term caloric restriction is associated cross-sectionally with longer telomere length (less aging).|One day|||ratio||Standard Deviation|Mean
848639|NCT01213329|Secondary|Identify Development of Donor-specific Hyperactivity|Identify, by studying recipients for development of donor specific hyperactivity and through immunopathologic analysis of renal allograft biopsies, immunologically stable renal transplant patients in whom immunosuppression can be safely minimized.|Pre-transplant, 6mo & 12mo post-transplant||||||
848640|NCT01213329|Primary|The Effect of T Cell Depletion on Phenotypic & Functional Profiles of Peripheral Blood Mononuclear Cells in Steroid-free Kidney Transplant Recipients.|Blood was collected to assess peripheral blood leukocytes prior to kidney transplant, 6 months & 12 months post-transplant as follows: to obtain absolute count of circulating CD4, CD8 positive T cells, B cells & NK cells, naive & memory cells (CD45RA, CD45RO), activated T cells (CD4/CD38, CD8/CD38), regulatory cells (CD4+ CD25+). To also obtain quantification of donor specific antibody cells for class I & class II donor HLA antigens, and measurement of C-reactive protein cells(marker of inflammation). 50cc of urine also obtained for measurement of urinary cytokines & markers of inflammation.|Pre-transplant, 6months & 12 months post-transplant|samples from 26 recipient/donor pairs were collected = 52 analyzed. Some samples were discarded due to processing inconsistencies.|||||
848641|NCT01154101|Secondary|Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) as an Indicator of the Pharmacodynamic Effects of SRT2104|The pharmacodynamic effects of SRT2104 was measured by biomarkers of psoriatic disease activity and/or sirtuin pathway activation (hsCRP and FGF21) in blood samples. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Day 1) and Days 28, 56 and 84|EAS population. Only those participants available at the specified time points were analyzed.||mg per Liter||Standard Deviation|Mean
848642|NCT01154101|Secondary|Change From Baseline in Fibroblast Growth Factor 21 (FGF21) as an Indicator of the Pharmacodynamic Effects of SRT2104|The pharmacodynamic effects of SRT2104 was measured by biomarkers of psoriatic disease activity and/or sirtuin pathway activation (hsCRP and FGF21) in blood samples. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Day 1) and Days 28, 56 and 84|EAS population. Only those participants available at the specified time points were analyzed.||Picogram per milliliter||Standard Deviation|Mean
848643|NCT01154101|Secondary|Maximum Plasma Concentration (Cmax) of 12 Weeks of Dosing With 250 Milligrams (mg), 500 mg and 1000 mg SRT2104 in the Fed State in Participants|A total of five blood samples (6 mL each) were obtained from each participant at any Visit 4 (Day 28 or Week 4), Visit 6 (Day 56 or Week 8) or Visit 8 (Day 84 or Week 12), for determination of SRT2104 plasma concentrations. No two samples were separated by less than an hour. One pre-dose sample was collected prior to taking study medication (30 minutes or less before dosing) at any Visit 4 (Day 28 or Week 4), Visit 6 (Day 56 or Week 8) or Visit 8 (Day 84 or Week 12). A single pharmacokinetic (PK) sample was collected in the time interval of 0.5 to 2 hours post-dose and also 3 to 6 hours post-dose at any Visit 4 (Day 28 or Week 4), Visit 6 (Day 56 or Week 8) or Visit 8 (Day 84 or Week 12). Two PK samples were collected in the time interval of 6 to 22 hours post dose at any Visit 4 (Day 28 or Week 4), Visit 6 (Day 56 or Week 8) or Visit 8 (Day 84 or Week 12).|One sample: Pre-dose (30 minutes or less before dosing), One sample: 0.5 to 2 hours post-dose and 3 to 6 hours post-dose and 2 samples 6 to 22 hours post dose, at any Visit 4 (Day 28 or Week 4), Visit 6 (Day 56 or Week 8) or Visit 8 (Day 84 or Week 12)|PK population.||ng/mL||Standard Deviation|Mean
848644|NCT01154101|Secondary|Area Under Curve (AUC) of 12 Weeks of Dosing With 0.25 g, 0.5 g and 1.0 g SRT2104 in the Fed State in Participants|A total of five blood samples (6 milliliter [mL] each) were obtained from each participant up to Week 12, for determination of SRT2104 plasma concentrations. No two samples were separated by less than an hour. One pre-dose sample was collected prior to taking study medication (30 minutes or less before dosing) at any Visit 4 (Week 4), Visit 6 (Week 8) or Visit 8 (Week 12). A single pharmacokinetic (PK) sample was collected in the time interval of 0.5 to 2 hours post-dose and also 3 to 6 hours post-dose at any Visit 4 (Week 4), Visit 6 (Week 8) or Visit 8 (Week 12). Two PK samples were collected in the time interval of 6 to 22 hours post dose at any Visit 4 (Week 4), Visit 6 (Week 8) or Visit 8 (Week 12).|Pre-dose (30 minutes or less before dosing: 1 sample), 0.5 to 2 hours and 3 to 6 hours post-dose (1 sample), 6 to 22 hours post-dose (2 samples) up to Week 12|PK population which comprised of all participants who received at least one dose of SRT2104 for whom a PK sample was obtained and analyzed.||Nanogram x hour/milliliter (ng*h/mL)||Standard Deviation|Mean
848645|NCT01154101|Secondary|Summary of Physician’s Global Assessment (PGA) Score After 4, 8 and 12 Weeks of Exposure|The severity of psoriatic lesions over the whole body were assessed by the investigator using the PGA scoring system. A 0 to 6 point rating scale was used, as follows: 0 = Clear (no signs of psoriasis), 1 = Almost clear (slight elevation, scale and/or erythema), 2 = Mild (mild plaque elevation, scale and/or erythema), 3 = Mild to moderate (mild plaque elevation with moderate erythema and/or scale), 4 = Moderate (moderate plaque elevation, scale and/or erythema), 5 = Moderate to severe (marked plaque elevation, scale and/or erythema), 6 = Severe (very marked plaque elevation, scale and/or erythema). Higher scores indicated worse psoriasis. Participants in the SRT2104 0.25 g dose group inadvertently used an incorrect version of the PGA scale and thus do not have PGA data available. Participants in the SRT2104 0.25 g dose group inadvertently used an incorrect version of the PGA scale and thus do not have PGA data available.|Weeks 4, 8 and 12|EAS Population. Only those participants available at the specified time points were analyzed.||Participants|||Count of Participants
848646|NCT01154101|Secondary|Number of Participants With Clinical Activity in Psoriasis Area and Severity Index (PASI) Score After 4, 8, and 12 Weeks of Exposure|PASI score was determined by evaluation of body surface area (BSA) covered by plaque psoriasis in 4 areas (head/neck, arms, trunk and legs with area score of 0.1, 0.2, 0.3 and 0.4 respectively). This test included combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale such that 0=0% involvement, 1=1-9%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89% and 6=90-100%) and severity (evaluated individually using a 5-point scale that ranged as 0=No evidence of sign, 1=slight evidence, 2=moderate evidence, 3=marked evidence and 4=very marked, most severe evidence of sign) of erythema, induration and desquamation in each of the same 4 areas. PASI score ranges from 0 (no psoriasis) to 72 (worse psoriasis). Final PASI=(sum of severity score for each area)x(% body affected score x area score).|Weeks 4, 8 and 12|Efficacy Analysis Set (EAS) population. Only those participants available at the specified time points were analyzed.||Participants|||Count of Participants
848647|NCT01154101|Primary|Number of Participants With Vital Signs of Potential Clinical Importance|Vital sign assessments included measurements of resting heart rate and blood pressure. Potential clinical concern range for systolic blood pressure: <85 and >160 millimeter of mercury (mmHg), for diastolic: <45 and >100 mmHg and heart rate: <40 and >110 beats per minute. Number of participants with vital signs of potential clinical importance are presented.|Up to Follow-up (Day 114)|SAF Population.||Participants|||Count of Participants
848648|NCT01154101|Primary|Number of Participants With Abnormal Electrocardiogram (ECG) Values|12-lead ECG was performed in the rested state with the participant in the supine position with ECG leads on for at least 5 minutes prior to ECG recording. ECGs included PR (PQ), QRS, QT and QT corrected by Bazett's formula (QTcB), QT corrected by Fridericia's formula (QTcF) intervals. Identification of any conduction abnormalities were recorded in the eCRF. If a participant’s QTc intervals were prolonged, then the ECG was done in triplicate with results reported as an average of the three ECGs. Number of participants with abnormal electrocardiogram (ECG) values are presented.|Up to Follow-up (Day 114)|SAF Population.||Participants|||Count of Participants
848693|NCT00685516|Secondary|Prostate Specific Antigen (PSA) After the Consumption of Green Tea (GT) and Black Tea (BT).||6 weeks|Pre and post blood samples unavailable for: 4 participants in Arm I (GT group), 3 participants in Arm II (control/water group) and 3 participants in Arm III (BT group).||ng/mL||Standard Deviation|Mean
848649|NCT01154101|Primary|Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance|The potential clinical concern range for clinical chemistry parameters were: Albumin:(low: <0.86 gram/Liter x LLN), Calcium:(low: <0.91 millimol/Liter [mmol/L] x LLN and high: >1.06 mmol/L x ULN), Creatinine: (high: >1.3 mmol /L x ULN), Glucose: (low: <0.71 mmol/L x LLN, high: >1.41 mmol/L x ULN), Magnesium: (low: <0.63 mmol/L x LLN, high: >1.03 mmol/L x ULN), Phosphorus: (low: <0.8 mmol/L x LLN, high: >1.14 mmol/L x ULN), Sodium: (low: <0.96 mmol/L x LLN, high: >1.03 mmol/L x ULN), Urea: (high: >1.5 mmol/L x ULN), Gamma glutamyl transferase: (high: >2 International units per L x ULN), Total bilirubin (high: 1.5 x ULN), both alanine amino transferase and aspartate amino transferase (high:≥ 2x ULN Units/L) and Bicarbonate: (low: <18 mmol/L and high: >32 mmol/L). Number of participants with clinical chemistry abnormalities of potential clinical importance are presented.|Up to Follow-up (Day 114)|SAF Population. Only those participants available at the specified time points were analyzed.||Participants|||Count of Participants
848650|NCT01154101|Primary|Number of Participants With Hematology and Coagulation Abnormalities of Potential Clinical Concern|Hematology parameters included hemoglobin, hematocrit, red blood cell count, red cell distribution width, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelets, white blood cell count and complete white blood cell count differential. Coagulation parameters included activated partial thromboplastin time and prothrombin time/international normalized ratio. The potential clinical concern range for hematology parameters were: white blood cell count (low: <0.67x10^9/Liter x lower limit of normal [LLN] and high: >1.82x10^9/L x upper limit of normal [ULN]), neutrophil count: (low: <0.83x10^9/Liter x LLN), hemoglobin (low: <0.85 gram/Liter x LLN and high: >1.03 gram/Liter x ULN for males and >1.13 gram/Liter x ULN for females), hematocrit with units ratio (high: >1.02 x ULN for males and >1.17 x ULN for females), platelet count (low: <0.67x10^9/Liter x LLN and high >1.57x10^9/Liter x ULN) and lymphocytes (low: <0.81x10^9/Liter x LLN).|Up to Follow-up (Day 114)|SAF Population.||Participants|||Count of Participants
848651|NCT01154101|Primary|Number of Participants With Any Adverse Events (AE) and Serious Adverse Events (SAE)|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant. The AE category in the data table includes participants who experienced serious or non-serious adverse events or both.|Up to Follow-up (Day 114)|Safety Analysis Set (SAF) population which comprised of all participants who received at least one dose of study medication.||Participants|||Count of Participants
848652|NCT01154101|Primary|Assessment of Clinical Activity by Improvement Score (Using Krueger Criteria): Number of Participants With Good or Excellent Improvement Score Based on Histological Assessments of Skin Biopsies After 12 Weeks of Exposure|According to the Krueger criteria, improvement score is classified as Good improvement defined as reduction in epidermal thickness by at least 30% normalized keratinocyte differentiation but most keratinocytes still express K16. Excellent improvement defined as reduction in epidermal thickness to normal or almost normal normalized keratinocyte differentiation and absent keratinocyte expression of K16. No improvement defined as no improvement in epidermal thickness keratinocyte differentiation or K16 expression on keratinocytes. A binomial response was defined for each participant according to whether the participant had an improvement score of “good or excellent improvement” (response=1) or not (response=0). Number of participants with good or excellent improvement score are presented.|12 weeks|The Efficacy Analysis Set (EAS) population comprised of all randomized participants who took at least one dose of study medication, had at least one activity measurement at Baseline, at least one post-Baseline study visit. Only those participants available at the specified time points were analyzed.||Participants|||Count of Participants
848653|NCT01130493|Secondary|Subject Preference|Subjects who completed both treatments were asked to indicate a preference for Treatment Period 1 or Treatment Period 2 or no preference. Preferences for a particular treatment period were mapped to the associated treatment and reported.|End of Study (week 11)|Participants who completed both treatment periods||Participants|||Count of Participants
848654|NCT01130493|Secondary|UPDRS Part II Plus Part III|"Unified Parkinson’s Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) and Part III (Motor Examination). Part II consists of 14 questions, each ranges from 0 (Normal/None) - 4 (Worst) with a total score of 0 - 72. Part III consists of 27 questions, each ranges from 0 (Normal/None) - 4 (Worst) with a total score of 0 - 108.
The UPDRS Part II Plus Part III scores ranged from 0 (no problems with daily living or mobility) to 180 (severe problems with daily living and mobility."|End of each double-blind treatment period.|Participants who completed both treatment periods||Scores on a scale||Standard Deviation|Mean
848655|NCT01130493|Secondary|"Total On With No Troublesome Dyskinesia"|"Using a Parkinson's disease diary, subjects recorded a state of “asleep”, ”OFF”, “ON without dyskinesia,” “ON with non-troublesome dyskinesia,” or “ON with troublesome dyskinesia” every 30 minutes over a 24-hour day for the last 3 days of each double-blind crossover treatment period.
Mean Total On with No Troublesome Dyskinesia was calculated. On Time is when medication is providing benefit with regard to mobility, slowness, and stiffness."|3 days of data immediately prior to the end of each 2 week treatment period|Participants who completed both treatment periods and completed PD diary for both Period 1 and Period 2||hours||Standard Deviation|Mean
848656|NCT01130493|Secondary|Total “OFF” Time During Waking Hours|"Using a Parkinson's disease diary, subjects recorded a state of “asleep”, ”OFF”, “ON without dyskinesia,” “ON with non-troublesome dyskinesia,” or “ON with troublesome dyskinesia” every 30 minutes over a 24-hour day for the last 3 days of each double-blind crossover treatment period.
Mean Total Off Time During Waking Hours was calculated. Off Time is Time when medication has worn off and is no longer providing benefit with regard to mobility, slowness, and stiffness."|3 days of data immediately prior to the end of each 2 week treatment period|Participants who completed both treatment periods and completed PD diary for both Period 1 and Period 2||hours||Standard Deviation|Mean
848657|NCT01130493|Primary|Percentage of “OFF” Time During Waking Hours|"Using a Parkinson's disease diary, subjects recorded a state of “asleep”, ”OFF”, “ON without dyskinesia,” “ON with non-troublesome dyskinesia,” or “ON with troublesome dyskinesia” every 30 minutes over a 24-hour day for the last 3 days of each double-blind crossover treatment period.
Mean percentage of “OFF” Time During Waking Hours was calculated. Off Time is Time when medication has worn off and is no longer providing benefit with regard to mobility, slowness, and stiffness."|3 days of data immediately prior to the end of each 2 week treatment period|Participants who completed both treatment periods and completed PD diary for both Period 1 and Period 2||Percent||Standard Deviation|Mean
848658|NCT01118741|Secondary|Clinical Response|To assess the clinical response measured by prostate specific antigen (PSA) progression at 6 months after treatment with the defined dose of disulfiram in prostate cancer (PCa) patients with evidence of biochemical relapse after local therapy. Reported as number of participants with PSA progression by 6 months.|Up to 6 months|||participants|||Number
848659|NCT01118741|Primary|Proportion of Subjects With a Demethylation Response at Each Dose Level|For both of the doses explored (i.e. disulfiram 250 mg PO daily and 500 mg PO daily) the proportion of subjects with a demethylation response was computed. A demethylation response was defined as a >=10% decrease from baseline in global 5-methyl cytosine content as assessed from peripheral blood mononuclear cells.|24 months|||proportion of participants||95% Confidence Interval|Number
848660|NCT01057862|Secondary|Gambling Symptom Assessment Scale (G-SAS)|The G-SAS is a 12-item self-rated scale designed to assess gambling symptom severity and change during treatment. Each item on the 12-item scale has a score ranging from 0 – 4. All items ask for an average symptom based on the past 7 days. Total score ranges from 0 – 48: extreme = 41 – 48, severe = 31 – 40, moderate = 21 – 30, mild = 8 – 20.|Weekly/bi-weekly visits|Enrollment was lower than expected and due to the low numbers of subjects completing the study (8 subjects completed all interventions) the numbers were not powerful enough to conduct a full analysis or provide any meaningful statistical analyses.||units on a scale||Standard Deviation|Mean
848661|NCT01057862|Primary|Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling (YBOCS-PG)|The Yale Brown Obsessive Compulsive Scale adapted for Pathological Gambling (PG-YBOCS) was developed to measure the severity and change in severity of pathological gambling symptoms.The PG-YBOCS is a 10-item clinician-administered questionnaire that measures the severity of PG over a specified time interval. Scores of 0 through 4 are assigned to each question according to the severity of the response (0 = least severe response, 4 = most severe response). The first five questions assess urges and thoughts associated with pathological gambling, whereas the last five questions assess the behavioral component of the disorder. Each set of questions is totaled separately as well as together for a total score. The total score can range from 0 (low) to 40 (most severe) with higher numbers representing a more severe form of pathological gambling.|Weekly/bi-weekly visits|Enrollment was lower than expected and due to the low numbers of subjects completing the study (7 subjects completed all interventions - 5 naltrexone and 2 placebo) the numbers were not powerful enough to conduct a full analysis or provide any meaningful statistical analyses.||units on a scale||Standard Deviation|Mean
848662|NCT00992264|Primary|Treatment Utilization for Smoking Cessation|confirmed use of pharmacotherapy or enrollment in health plan-sponsored counseling program|12 months|Twenty-seven participants were excluded for not being enrolled in the health plan during the study period and not having access to the provided adjunct treatment.||% of participants using adjunct treatmen|||Number
848663|NCT00992264|Primary|Smoking Abstinence|7 day point prevalent abstinence|12 months|Missing data imputed, so all enrolled participants were included in the final intent to treat analytic sample.||percentage of abstinent participants|||Number
848664|NCT00972478|Secondary|Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL|Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|Up to week 26|Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 4.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.||Participants|||Number
848665|NCT00972478|Secondary|Response Rate (Complete Response [CR]+Partial Response [PR]) (Phase II)|Objective disease status is evaluated according to the 2007 revised Cheson et al. criteria. Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow (BM) must be negative if positive at baseline. Normalization of markers. Partial Response (PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.|Up to week 26|Eligible patients who received the protocol treatment in the Phase II portion of the study||percentage of participants||95% Confidence Interval|Number
848666|NCT00972478|Secondary|Overall Survival (Phase II)|From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Up to 2 years|Eligible patients who received the protocol treatment in the Phase II portion of the study.||percentage of participants||95% Confidence Interval|Number
848667|NCT00972478|Primary|Progression-free Survival (Phase II)|From date of registration to date of first documentation of progressive disease, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact.|Up to 2 years|Eligible patients who received the protocol treatment in the Phase II portion of the study.||percentage of participants||95% Confidence Interval|Number
848668|NCT00972478|Primary|Safe Dose of Vorinostat to be Used in Combination With R-CHOP Assessed by CTCAE Version 4.0 (Phase I)|Safe dose of Vorinostat (in combination with R-CHOP) at which 3/10 or fewer patients have doselimiting toxicities (DLT). Toxicities graded according to the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE 4.0). DLT apply only during cycle 1 and should be drug-related (possible, probable, or definite).|21 days|Phase I eligible patients receiving any amount of the assigned dose during Cycle 1 (1 Cycle = 21 days) or whom developed a dose-limiting toxicity (DLT).||mg PO Once daily Days 1-9|||Number
848708|NCT00644995|Primary|Minutes Per Week of Moderate Physical Activity|Mean change from baseline as assessed using International Physical Activity Questionnaire (IPAQ)|6 months|||mean change in minutes per week of PA||Full Range|Mean
848709|NCT00644995|Primary|Days Walk Per Week|Mean change in days walk per week from baseline|6 months|||mean change in days walked per week||Full Range|Mean
848673|NCT00896441|Secondary|Hamilton Anxiety Scale|Hamilton Anxiety Scale (HAMA) was utilized. Scores range from 0-56, with higher scores indicating more anxiety. The change score utilized baseline and Day 56 (week 8) scores. The change scores was HAMA day 1 less Ham A day 56 / HAMA Day 1. Thus, larger numbers equal a greater reduction in anxiety.|% change in anxiety from Day 1 to Day 56 (week 8)|Only participants completing the protocol are included in the analysis. Only participants in the Depressed group were analyzed for change in anxiety symptoms.||percentage of change in anxiety||Standard Deviation|Mean
848674|NCT00896441|Primary|Voxel-wise Changes in Resting State Functional Connectivity to the Posterior Cingulate Cortex|The dependent variable, measured in more than 30,000 voxels across the whole brain, was the functional connectivity between the posterior cingulate cortex seed region and each voxel. This is derived as the correlation coefficient between the blood-oxygen-level dependent (BOLD) signal timeseries in the seed region and the BOLD signal timeseries in each voxel.|baseline and week 8|Owing to the limited sample size, we first examined this measure in the depressed subjects using a paired-sample t-test at each of the 30,000+ voxels. No significant voxels were detected in this analysis and so subsequent analyses combining the depressed subjects and the healthy control subjects in a single model were not performed.||significant voxels|||Number
848675|NCT00896441|Primary|Hamilton Depression Rating Scale Percent Change From Day 0 to D56|Utilized the Hamilton Depression Rating Scale (HAM), 21-item version to assess depressive symptoms, with a range of 0-63. Higher scores indicate more depression. For the change score, it is Baseline less Day 56 HAM total / Baseline. Thus, larger values mean a greater decrease in the level of depression|% change from baseline to Day 56 ( week 8)|Only participants completing the protocol are included in the analysis; thus, the N = 12. Only participants in the Depressed group were analyzed for change in depressive symptoms.||percentage of change in depression||Standard Deviation|Mean
848676|NCT00880048|Secondary|Change From Baseline in the MSFQ Total Score in Females|MSFQ included five items with a score ranging from 1 to 6 (1 = greater than normal; 2 = normal; 3 = minimally diminished; 5 = markedly diminished; and 6 = totally absent). The following areas of sexual functioning were included: diminished/absent libido; arousal difficulties; orgasm difficulties/anorgasmia; erectile dysfunction (males only) and degree of sexual satisfaction. A total score was used as a global measure of sexual dysfunction. The Baseline MSFQ requested the participant reflect back over the past month. For the treatment period, the follow-up MSFQ requested the participant reflect back over the past week. Change from Baseline was the value at post-Baseline visit minus Baseline value.|Baseline and up to Week 6|All Subject Population (female). Only those participants available at the specified time points were analyzed.||scores on a scale||Standard Error|Least Squares Mean
848677|NCT00880048|Secondary|Change From Baseline in the Massachusetts Sexual Function Questionnaire (MSFQ) Total Score in Males|MSFQ included five items with a score ranging from 1 to 6 (1 = greater than normal; 2 = normal; 3 = minimally diminished; 5 = markedly diminished; and 6 = totally absent). The following areas of sexual functioning were included: diminished/absent libido; arousal difficulties; orgasm difficulties/anorgasmia; erectile dysfunction (males only) and degree of sexual satisfaction. A total score was used as a global measure of sexual dysfunction. The Baseline MSFQ requested the participant reflect back over the past month. For the treatment period, the follow-up MSFQ requested the participant reflect back over the past week. Change from Baseline was the value at post-Baseline visit minus Baseline value.|Baseline and up to Week 6|All subjects Population (males). Only those participants available at the specified time points were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
848678|NCT00880048|Secondary|Number of Incidences of Discontinuation Emergent Signs and Symptoms Using the Discontinuation-Emergent Signs and Symptoms (DESS)|The DESS scale consisted of 43 signs and symptoms, scored as ‘new symptom’, ‘old symptom but worse’, ‘old symptom but improved’ or ‘symptom not present/old symptom but unchanged’. The total number of new signs and symptoms, old symptoms but worse, old symptoms but improved and the total number of new or old-but-worse signs and symptoms were calculated for each treatment and visit. n = number of subjects who had at least one of the 43 symptoms in the specified category. The summary for a specified category are of the number of symptoms the n subjects had in that category. Treatment period was up to Week 6.|Up to 17 days post-treatment|All subjects Population. Only those participants available at the specified time points were analyzed.||Number of Incidences||Standard Deviation|Mean
848710|NCT00644995|Primary|Abstinent From Smoking|self-reported 7 day point prevalent abstinence with non-responders coded as smokers|6 months|||percentage of participants|||Number
848679|NCT00880048|Secondary|Number of Participants With Suicide-Related Events Based on the Columbia Suicidality Severity Rating Scale (CSSRS)|Assessment of suicidality were done through use of the CSSRS for suicidal ideation and suicidal behavior. For suicidal ideation ratings were 1 to 5, where 1. Wish to be dead, 2. Non-specific active suicidal thoughts, 3. Active suicidal ideation without intent to act, 4. Active suicidal ideation with any methods (not plan) without intent to act, 5. Active suicidal ideation with specific plan and intent and for suicidal behavior ratings were 6 to 12, Where 6. Actual attempt, 7. Engaged in non-suicidal self-injurious behavior, 8. Interrupted attempt, 9. Aborted attempt, 10. Preparatory acts or behavior, 11. Suicidal behavior, 12. Completed suicide. n= number participants with at least one CSSRS assessment after the first dose of study medication (i.e. on treatment or post treatment). Only those categories from CSSRS (1-12) are presented for which symptoms were actually observed in the participants. Categories with null values for all the arms have not been presented.|Up to 17 days post-treatment|The All Subjects Population was defined as all participants who received at least one dose of study medication. Only those participants with data available at the indicated time points were analyzed.||Participants|||Count of Participants
848680|NCT00880048|Secondary|Number of HAM-D Remitters|A HAMD remitter was defined as a participant who had a HAMD Total Score <=7. The HAMD total score was calculated for each participant at each time point. Those participants with no missing value for HAMD total score were categorized as having a HAMD total score of <=7 or >7.|Up to Week 6|ITT Population. Only those participants available at the specified time points were analyzed.||Participants|||Count of Participants
848681|NCT00880048|Secondary|Change From Baseline in the MSQ Sleep Quality and Refreshing Value of Sleep|The MSQ was a self-rated scale designed to assess effects on sleep and effects on next day functioning. The following variables were assessed in order to determine effects on sleep: total sleep time, sleep onset latency, number of nocturnal awakenings, wake time after sleep onset and sleep quality (from poor, assigned a score of 1, to excellent, assigned a score of 10). The refreshing value of the sleep was also determined (poor assigned a score of 1, to excellent, assigned a score of 10). Value at randomization was the Baseline value. Change from Baseline was calculated for each domain separately. Change from Baseline was the difference between score at the time point being analyzed to randomization. If no post- randomization scores were available, change from Baseline was set to missing.|Baseline and up to Week 6|ITT Population. Only those participants available at the specified time points were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
848682|NCT00880048|Secondary|Change From Baseline in the MSQ Number of Nocturnal Awakenings|The MSQ was a self-rated scale designed to assess effects on sleep and effects on next day functioning. The following variables were assessed in order to determine effects on sleep: total sleep time, sleep onset latency, number of nocturnal awakenings, wake time after sleep onset and sleep quality (from poor, assigned a score of 1, to excellent, assigned a score of 10). The refreshing value of the sleep was also determined (poor assigned a score of 1, to excellent, assigned a score of 10). Value at randomization was the Baseline value. Change from Baseline was calculated for each domain separately. Change from Baseline was the difference between score at the time point being analyzed to randomization. If no post- randomization scores were available, change from Baseline was set to missing.|Baseline and upto Week 6|ITT Population. Only those participants available at the specified time points were analyzed.||Number of awakenings||Standard Error|Least Squares Mean
848683|NCT00880048|Secondary|Change From Baseline in Morning Sleep Questionnaire (MSQ) Total Sleep Time, Sleep Onset Latency and Wake Time After Sleep Onset|The MSQ was a self-rated scale designed to assess effects on sleep and effects on next day functioning. The following variables were assessed in order to determine effects on sleep: total sleep time, sleep onset latency, number of nocturnal awakenings, wake time after sleep onset and sleep quality (from poor, assigned a score of 1, to excellent, assigned a score of 10). The refreshing value of the sleep was also determined (poor assigned a score of 1, to excellent, assigned a score of 10). Value at randomization was the Baseline value. Change from Baseline was calculated for each domain separately. Change from Baseline was the difference between score at the time point being analyzed to randomization. If no post- randomization scores were available, change from Baseline was set to missing.|Baseline and up to Week 6|ITT Population. Only those participants available at the specified time points were analyzed.||minutes (min)||Standard Error|Least Squares Mean
848684|NCT00880048|Secondary|Change From Baseline in the Cognitive and Physical Function Questionnaire (CPFQ) Total Score|CPFQ was a brief self-report scale which was designed to measure cognitive and executive dysfunction in mood and anxiety disorders. The CPFQ comprised of 7 questions assessing each of the most common complaints of depressed participants reporting fatigue or cognitive/executive problems. Each question was rated on a scale of 1 to 6, with 1 indicating greater than normal functioning, 2, indicating normal functioning, and with higher numbers indicating poorer functioning. Two versions of the CPFQ were utilized during the study. The Baseline CPFQ requested the participant reflect back over the past month. For the treatment period, the CPFQ requested the participant reflect back over the past week. Value at randomization was the Baseline value. Change from Baseline in Total Score was the difference between CPFQ Score at the time point being analyzed to randomization. If no post- randomization scores were available, change from Baseline was set to missing.|Baseline and up to Week 6|ITT Population. Only those participants available at the specified time points were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
848685|NCT00880048|Secondary|Change From Baseline in the Clinical Global Impression-Severity of Illness (CGI-S) Score|The CGI-S assessed scores range from 1 – Very much Improved to 7 – Very much worse, with 0 representing a participant that was not assessed. For the CGI-S, remote, blinded MedAvante, raters assessed the participant’s severity of illness considering their total clinical experience with the particular population being studied and information obtained during the Baseline HAMD interview with the participant. Value at randomization was the Baseline value. Change from Baseline in total score was the difference between CGI-S Score at the time point being analyzed to randomization. If no post- randomization scores were available, change from Baseline was set to missing.|Baseline and up to Week 6|ITT Population. Only those participants available at the specified time points were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
848711|NCT00644995|Primary|Depression Score|% with significant change (50% reduction in SCL [Symptom Checklist] depression score)|6 months|||percentage of participants|||Number
848712|NCT00602836|Secondary|Number of Participants With FISH Testing at Baseline Who Also Had a Clinical Response (CR, nPR, or PR).|Response categories described in above outcome measures. FISH status describe in baseline characteristics section.|During treatment (up to 5 years)||||||
848686|NCT00880048|Secondary|Percentage of Participants With Clinical Global Impression- Global Improvement (CGI-I) Score|The CGI-I assessed scores range from 1 – Very much Improved to 7 – Very much worse, with 0 representing a participant that was not assessed. The assessed scores were dichotomized. Scores of 1 or 2 was in the first category, scoring 1. All other scores (except zero which was regarded as missing) was in the second category, scoring 0. The percentage of participants in the first category was calculated for each assessment.|Up to Week 6|ITT Population. Only those participants available at the specified time points were analyzed.||Percentage of participants|||Number
848687|NCT00880048|Secondary|Change From Baseline in the HAM-D Anxiety Factor Score (Sum of Items 10, 11, 12, 13, 15 and 17)|The anxiety score was extracted from the HAM-D-17 and comprises of items 10, 11, 12, 13 and 15 from the HAM-D scale. The anxiety score was calculated by summing the individual response scores to these questions. It was a checklist of items that were ranked on a scale of 0-4 or 0-2. The lowest possible score was 0 (absence of depression) and the highest possible score was 18 (most severe measure of depression). Due to the small number of items, missing data was not imputed for the anxiety score. If either of the anxiety items was missing, the total score was not calculated at that visit. Value at randomization was the Baseline value. Change from Baseline in anxiety score was the difference between the anxiety score at the time point being analyzed to randomization. If no post- randomization scores were available, change from Baseline was set to missing.|Baseline and up to Week 6|ITT Population. Only those participants available at the specified time points were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
848688|NCT00880048|Secondary|Change From Baseline in the 16-item Quick Inventory of Depressive Symptomatology (QIDS-SR 16) Total Score|QIDS-SR assessed symptoms severity of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnostic criterion for major depressive disorder. It consisted of 16 separate items, defining 9 DSM-IV symptom criterion domains. A total score was obtained by summing scores on each domain. The lowest possible score was 0, which represented an absence of depression; the highest possible score was 27, which represented the most severe measure of depression. Due to the small number of items, missing data was not imputed for the QIDS-SR total score. If any of the 9 domains above were missing, the total score was not calculated at that visit. Value at randomization was the Baseline value. Change from Baseline in total score was the difference between QIDS total score at the time point being analyzed to randomization. If no post- randomization scores were available, change from Baseline was set to missing.|Baseline and up to Week 6|ITT Population. Only those participants available at the specified time points were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
848689|NCT00880048|Secondary|Change From Baseline in the Bech Melancholia Scale Total Score (Sum of Items 1, 2, 7, 8, 10, and 13 of the 17-item HAM-D Scale)|The BECH scale was extracted from the HAMD-17 and comprised the 6 items (sum of items 1, 2, 7, 8, 10, and 13 of the 17-item HAM-D scale): Depressed Mood, Feelings of Guilt, Work and Activities, Retardation, Anxiety Psychic and Somatic Symptoms General. The BECH Total Score was calculated by summing the individual response scores. It was a checklist of items that were ranked on a scale of 0-4 or 0-2. The lowest possible score was 0 (absence of depression) and the highest possible score was 22 (most severe measure of depression). Due to the small number of items , missing data was not imputed for the BECH Total Score. If any of the 6 items above were missing, the total score was not calculated at that visit. Value at randomization was the Baseline value. Change from Baseline in BECH Total Score was the difference between BECH Total Score at the time point being analyzed to randomization.|Baseline and up to Week 6|ITT Population. Only those participants available at the specified time points were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
848690|NCT00880048|Secondary|Number of Participants Who Maintained Clinical Response by Week 6|The start of the ‘maintained antidepressant response’ was the time at which a participant demonstrates a 50% reduction from randomization in their HAM-D total score and where this response was maintained until the end of the treatment phase (week 6). Participants who met the 50% reduction at week 6 without having met it at week 4 were considered to have reached a maintained response, and therefore were censored at week 6. Where a participant met the criteria for maintained antidepressant response, the “time (in days) to maintained antidepressant response” was calculated as: (Date of assessment at which the maintained response commences minus Date of randomization) plus 1. Where a participant did not met the criteria for maintained antidepressant response, their time to response was censored at the last on-treatment assessment they undertake, up to and including the week 6 assessment.|Up to Week 6|ITT Population.||Participants|||Number
848691|NCT00880048|Secondary|Percentage of Participants With a >=50% Reduction From Baseline in HAM-D Total Score|"HAM-D was use to measure the severity of depressive symptoms in participants with primary depressive illness. It was a checklist of items that were ranked on a scale of 0-4 or 0-2. The HAM-D Total Score was calculated by summing the individual response scores. The lowest possible score was 0 (absence of depression) and the highest possible score was 52 (most severe measure of depression). For the last observation carried forward analyses, the most recent post randomization total score (as opposed to individual responses) was carried forward and used in the calculation of the change from randomization value. If the responses to more than 1 question were missing for a participant at a particular time point, the total score was not calculated. Data was presented as percent of HAM-D responders which was defined as participants who has a >=50% reduction from randomization in HAM-D total score."|Up to Week 6|ITT Population. Only those participants available at the specified time points were analyzed.||Percentage of participants|||Number
848692|NCT00880048|Primary|Change From Baseline in the 17-item Hamilton Depression Rating Scale (HAM-D) Total Score|"HAM-D was use to measure the severity of depressive symptoms in participants with primary depressive illness. It was a checklist of items that were ranked on a scale of 0-4 or 0-2. Items with quantifiable severity were scored 0 (lowest severity) to 4 (greatest severity); The HAM-D total score was calculated by summing the individual response scores. The lowest possible score was 0 (absence of depression) and the highest possible score was 52 (most severe measure of depression). For the last observation carried forward analyses, the most recent post randomization total score (as opposed to individual responses) was carried forward and used in the calculation of the change from randomization (Baseline) value. If the responses to more than 1 question were missing for a participant at a particular time point, the total score was not calculated. Change from Baseline in total score was the difference between HAM-D total score at the time point being analyzed and randomization."|Baseline and up to Week 6|ITT Population. Only those participants available at the specified time points were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
848694|NCT00685516|Secondary|Concentration of Tea Polyphenols and Methyl-metabolites in Urine After the Consumption of Green Tea (GT) and Black Tea (BT).|Concentration of tea polyphenols and methyl-metabolites in urine after the consumption of GT and BT. No polyphenols were found after water consumption|6 weeks|"Urine concentration of (-)-epigallocatechin-3-gallate (EGCG), (-)-epicatechin-3-gallate (ECG), (-)-epigallocatechin (EGC) , (-)-epicatechin (EC), 4'-O-methylEGC (4'-MeEGC), 4-O-methylEGCG (4-OmethylEGCG)."||umol/g creatinine||Standard Deviation|Mean
848695|NCT00685516|Secondary|Concentration of Tea Polyphenols, Their Metabolites, and Colonic Metabolites in Prostate Tissue|Examine levels of tea polyphenols and methylated tea polyphenol metabolites in fresh frozen radical prostatectomy tissue and urine, urinary oxidative DNA damage (8OHdG) and serum prostate-specific antigen (PSA) levels.|6 weeks|"Concentration of tea polyphenols and methyl-metabolites in prostate tissue after the consumption of GT and BT. No polyphenols were found after water consumption.
(-)-epigallocatechin-3-gallate (EGCG), (-)-epicatechin-3-gallate (ECG), (-)-epigallocatechin (EGC) , (-)-epicatechin (EC), 4'-O-methylEGC (4'-MeEGC), 4-O-methylEGCG (4-OmethylEGCG)."||(pmol/g tissue)||Standard Deviation|Mean
848696|NCT00685516|Primary|Effect of Green Tea (GT) and Black Tea (BT) Consumption on Percentage of Cells With Positive Staining for Apoptosis, Proliferation, Oxidation, and Inflammation in Malignant Radical Prostatectomy Tissue Compared to Water Control Using Immunohistochemistry.|To determine the effect of Green Tea and Black Tea consumption on Prostate cancer tissue by examining programmed cell death, cell proliferation, cell oxidation, and cellular inflammation in that malignant radical prostatectomy tissue compared to water control using immunohistochemistry.|6 weeks|subjects that completed study||percent positive of total cells||Standard Deviation|Mean
848697|NCT00659230|Secondary|Clinician Administered PTSD Scale Subscale C Score|The Clinician Administered PTSD Subscale C (CAPS-C) measures the Avoidance and emotional numbing cluster of PTSD symptoms. Higher scores indicate greater severity. Range for CAPS-C is zero to 56. The CAPS has acceptable test-retest reliability (0.98), sensitivity (0.84), specificity (0.95), internal consistency (0.76-0.88) and validity (κ=0.78).|Baseline, week 2, 4, and 6|Participants who returned for at least one post-randomization visit and had source documentation (in placebo group 2 did not return and the source documentation for 5 participants was lost; for nepicastat group 3 did not return and the source documentation for 4 participants was lost).||units on a scale||Standard Deviation|Mean
848698|NCT00659230|Secondary|Clinician Administered PTSD Scale Subscale B Score|The Clinician Administered PTSD Subscale B (CAPS-B) measures the re-experiencing cluster of PTSD symptoms. Higher scores indicate greater severity. Range for CAPS-B is zero to 40. The CAPS has acceptable test-retest reliability (0.98), sensitivity (0.84), specificity (0.95), internal consistency (0.76-0.88) and validity (κ=0.78). Blake, D.D., Weathers, F.W., Nagy, L.M., Kaloupek, D.G., Gusman, F.D., Charney, D.S., Kean, T.M., 1995, The development of a clinician-administered PTSD scale. Journal of Traumatic Stress, 8:75-90.|6 weeks|Participants who returned for at least one post-randomization visit and had source documentation (in placebo group 2 did not return and the source documentation for 5 participants was lost; for nepicastat group 3 did not return and the source documentation for 4 participants was lost).||units on a scale||Standard Deviation|Mean
848699|NCT00659230|Secondary|Clinician Administered PTSD Scale Total Score|The Clinician Administered PTSD Scale (CAPS) measures the full spectrum of PTSD symptoms. Higher scores indicate greater severity. Range for CAPS is zero to 136. The CAPS has acceptable test-retest reliability (0.98), sensitivity (0.84), specificity (0.95), internal consistency (0.76-0.88) and validity (κ=0.78).|Baseline, week 2,4, and 6|Participants who returned for at least one post-randomization visit and had source documentation (in placebo group 2 did not return and the source documentation for 5 participants was lost; for nepicastat group 3 did not return and the source documentation for 4 participants was lost).||units on a scale||Standard Deviation|Mean
848700|NCT00659230|Primary|Clinician Administered PTSD Scale Subscore D (Hyperarousal)|The Clinician Administered PTSD Scale subscore D (CAPS-D) measures the hyperarousal cluster for PTSD symptoms (5 items). Higher scores indicate greater severity. Range for CAPS-D is zero to 40. The CAPS has acceptable test-retest reliability (0.98), sensitivity (0.84), specificity (0.95), internal consistency (0.76-0.88) and validity (κ=0.78).|Baseline, week 2, 4 and 6|Participants who returned for at least one post-randomization visit and had source documentation (in placebo group 2 did not return and the source documentation for 5 participants was lost; for nepicastat group 3 did not return and the source documentation for 4 participants was lost).||units on a scale||Standard Deviation|Mean
848705|NCT00644995|Secondary|Quit Attempt|% who made a quit attempt, defined as intentionally not smoking for at least 24 hours|6 months|||percent of participants|||Number
848706|NCT00644995|Secondary|Number of Cigarettes Smoked Per Day|Mean change in cigarettes smoked per day from baseline|4 months|||mean change in number of cigs/day smoked||Full Range|Mean
848707|NCT00644995|Primary|Minutes Per Week of Vigorous Physical Activity|Mean change from baseline assessed using IPAQ physical activity scale|6 months|||minutes per week||Full Range|Mean
848720|NCT00602836|Secondary|Number of Participants Who Convert From a CR With Minimal Residual Disease (MRD) Positive Status After PCR to a CR With MRD-negative Status After 6 Courses of Consolidation With Lenalidomide|MRD refers to small number of leukemic cells that remain in the participant during treatment or after treatment when the participant has achieved CR. For all participants who achieved CR, the follow-up bone marrow sample was tested for malignant B cells to determine if there was any MRD.|12 months||||||
848721|NCT00602836|Secondary|Number of Participants Who Convert From a Nodular Partial Response (nPR), Partial Response (PR), or Stable Disease (SD) After Pentostatin, Cyclophosphamide, and Rituximab (PCR) to a Complete Response (CR) After 6 Courses of Consolidation With Lenalidomide|"According to the NCIWG criteria, response is defined as follows:
nPR: Meets all criteria for CR, as described above, except the presence of residual clonal nodules in the bone marrow PR: 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence/absence of constitutional symptoms; plus ≥1 of the following: ≥1500/μL polymorphonuclear leukocytes, >100000/μL platelets, >11.0 g/dL hemoglobin or 50% improvement for these parameters without transfusions SD: participant who does not meet any of the criteria described above"|12 months||||||
848722|NCT00602836|Primary|Number of Participants With Complete Response (CR)|"A complete response, as defined by the National Cancer Institute Working Group (NCIWG), requires all of the following for a period of at least 2 months:
- CR: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count; confirmed by bone marrow (BM) aspirate & biopsy"|12 months|||participants|||Number
848723|NCT00485953|Secondary|Markers of Bone Resorption and Bone Formation||at 24 months|||percentage change||Standard Error|Mean
848724|NCT00485953|Secondary|BMD by DXA at the Femoral Neck and Total Hip|BMD is the bone mineral density of the femoral neck and total hip measured using the dual-energy x-ray absorptiometry (DXA) scan.|at 24 months|||percentage change||Standard Error|Mean
848725|NCT00485953|Primary|BMD of Spine by DXA|BMD is the bone mineral density of the lumbar spine measured using the dual-energy x-ray absorptometry (DXA) scan.|at 24 months|||percentage change||Standard Error|Mean
848726|NCT00325819|Secondary|Parent Time Lost From Work|Parents were asked to report whether they were scheduled to work on the day of the vaccination visit (but following that visit) or the next day and, if so, whether they had to miss work to care for their infant because of fever, fussiness, or possible vaccine reaction on those days.|Through the day after vaccination|Refers to the number of participants for whom parents reported that they were scheduled to work on the day of the vaccination visit or the day following the child's vaccination visit.||percentage of participants|||Number
848727|NCT00325819|Secondary|Infant Time Lost From Sleep|Parents were asked about their infant's sleep on the night following the vaccinations. They were asked to report whether their infant slept much less than usual, less than usual, about the usual amount, more than usual, or much more than usual on that night.|On the night following vaccinations|||percentage of participants|||Number
848728|NCT00325819|Secondary|Parent Time Lost From Sleep|Parents were asked about their sleep on the night following the vaccinations. They were asked to report whether they slept much less than usual, less than usual, about the usual amount, more than usual, or much more than usual on that night.|On the night following vaccinations|||percentage of participants|||Number
848729|NCT00325819|Secondary|Infant Fussiness|Parents were asked to record level of fussiness (compared with the child’s usual) within 32 hours of vaccination, using the categories much less than usual, less than usual, about usual, more than usual, and much more than usual.|Within 32 hours of vaccination|||percentage of participants|||Number
848730|NCT00325819|Secondary|Medical Utilization|Telephone calls to the consulting nurse or the child’s physician that were made due to concerns regarding an acute illness, fever, or possible vaccine reaction and outpatient, urgent care, and emergency room visits that were for evaluation of an acute illness, fever, or a possible vaccine reaction, within 32 hours of vaccination.|Within 32 hours of vaccination.|||percentage of participants|||Number
848731|NCT00325819|Secondary|Study Assignment Unblinded|The need for unblinding at any time during the study|At any time during participation in the study|||percentage of participants|||Number
848732|NCT00325819|Secondary|Fever >=39C Within 32 Hours of Vaccination.|Fever, defined as rectal temperature >=39C within 32 hours of vaccination.|Fever within 32 hours following vaccination|Temperature values were missing for one subject in the acetaminophen group and two subjects in the placebo group.||percentage of participants|||Number
848733|NCT00325819|Primary|Fever >=38C Within 32 Hours of Vaccination.|Fever, defined as rectal temperature >=38C within 32 hours of vaccination.|Fever within 32 hours following vaccination|Temperature values were missing for one subject in the acetaminophen group and two subjects in the placebo group.||percentage of participants|||Number
848734|NCT00287365|Secondary|% Decrease in FVC in Asthmatics Between Subjects With GSTM1 Null Genotype Compared to GSTM1 Sufficient Subjects||6 hours post exposure|||percentage of FVC predicted||Standard Error|Mean
848735|NCT00287365|Secondary|Secondary Endpoints Include Post Ozone Airway PMN Influx Between Subjects With GSTM1 Null Genotype Compared to GSTM1 Sufficient Subjects||6 hours post exposure|||percentage of cells||Standard Error|Mean
848736|NCT00287365|Primary|Post Ozone Change in Lung Function (FEV1) Between Subjects With GSTM1 Null Genotype Compared to GSTM1 Sufficient Subjects||6 hours post exposure|Mild asthmatics exposed to ozone||percentage of FEV1 predicted||Standard Error|Mean
848737|NCT00245518|Primary|Social Functioning Due to Emotional Role Functioning as Assessed by the Short Form 36 Questionnaire|The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perception, Physical role functioning, Emotional role functioning, Social role functioning, Mental health|baseline, 6 weeks, 12 weeks|||units on a scale||Standard Deviation|Mean
848738|NCT00245518|Primary|Role Limitations Due to Emotional Role Functioning as Assessed by the Short Form 36 Questionnaire|The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perception, Physical role functioning, Emotional role functioning, Social role functioning, Mental health|baseline, 6 weeks, 12 weeks|||units on a scale||Standard Deviation|Mean
848739|NCT00245518|Primary|Role Limitations Due to Physical Health as Assessed by the Short Form 36 Questionnaire|The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perception, Physical role functioning, Emotional role functioning, Social role functioning, Mental health|baseline, 6 weeks, 12 weeks|||units on a scale||Standard Deviation|Mean
848740|NCT00245518|Primary|General Health Perceptions as Assessed by the Short Form 36 Questionnaire|The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perception, Physical role functioning, Emotional role functioning, Social role functioning, Mental health|baseline, 6 weeks, 12 weeks|||units on a scale||Standard Deviation|Mean
848741|NCT00245518|Primary|Body Pain as Assessed by the Short Form 36 Questionnaire|The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perception, Physical role functioning, Emotional role functioning, Social role functioning, Mental health|baseline, 6 weeks, 12 weeks|||units on a scale||Standard Deviation|Mean
848742|NCT00245518|Primary|Physical Functioning as Assessed by the Short Form 36 Questionnaire|The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perception, Physical role functioning, Emotional role functioning, Social role functioning, Mental health|baseline, 6 weeks, 12 weeks|||units on a scale||Standard Deviation|Mean
848743|NCT00245518|Primary|Fatigue as Assessed by the Short Form 36 Questionnaire|The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perception, Physical role functioning, Emotional role functioning, Social role functioning, Mental health|baseline, 6 weeks, 12 weeks|||units on a scale||Standard Deviation|Mean
848744|NCT00245518|Primary|Physical Health as Assessed by the Short Form 36 Questionnaire|The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perception, Physical role functioning, Emotional role functioning, Social role functioning, Mental health|baseline, 6 weeks, 12 weeks|||units on a scale||Standard Deviation|Mean
848745|NCT00245518|Primary|Mental Health as Assessed by the Short Form 36 Questionnaire|The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perception, Physical role functioning, Emotional role functioning, Social role functioning, Mental health|baseline, 6 weeks, 12 weeks|||units on a scale||Standard Deviation|Mean
848746|NCT00245518|Primary|Hot Flashes as Assessed by the Blatt-Kuppermann Index (Hot Flash Component)|Hot flashes were assessed using symptom severity 0= none, slight=1, moderate=2, and severe = 3. Hot flashes have a weighting factor of 4 on the overall Blatt-Kuppermann index, making score ranges 0-12, with 12 being the most severe hot flashes.|baseline, 6 weeks, 12 weeks|||units on a scale||Standard Deviation|Mean
848747|NCT00245518|Primary|Daytime Sleepiness as Assessed by Epworth Sleepiness Scale (ESS)|The ESS is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. Most people engage in those activities at least occasionally, although not necessarily every day. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person’s average sleep propensity in daily life (ASP), or their ‘daytime sleepiness’.|baseline, 6 weeks, 12 weeks|||units on a scale||Standard Deviation|Mean
848748|NCT00245518|Primary|Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Overall Sexual Satisfaction|IIEF Questionnaire is used for the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials, one domain being sexual satisfaction. A score of 0-5 is awarded to each of the 2 questions which refer to the past 4 weeks only. The score rangers from 2-10, with a score of 2 indicating very dissatisfied and 10 being very satisfied.|baseline, 6 weeks, 12 weeks|||units on a scale||Standard Deviation|Mean
848749|NCT00245518|Primary|Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Sexual Desire|IIEF Questionnaire is used for the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials, one domain being sexual desire. A score of 0-5 is awarded to each of the 2 questions which refer to the past 4 weeks only. The score rangers from 2-10, with a score of 2 indicating very low or none at all, and 10 representing almost always/very high.|baseline, 6 weeks, 12 weeks|||units on a scale||Standard Deviation|Mean
848750|NCT00245518|Primary|Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Orgasmic Function|IIEF Questionnaire is used for the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials, one domain being satisfaction with orgasm. A score of 0-5 is awarded to each of the 2 questions which refer to the past 4 weeks only. The score rangers from 1-10, with a score of 0 indicating that no sexual stimulation or intercourse was attempted in the last 4 weeks, 1= almost never or never ejaculated, 10= almost always or always|baseline, 6 weeks, 12 weeks|||units on a scale||Standard Deviation|Mean
848751|NCT00245518|Primary|Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Intercourse Satisfaction|IIEF Questionnaire is used for the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials, one domain being satisfaction with intercourse. A score of 0-5 is awarded to each of the 3 questions which refer to the past 4 weeks only. The score rangers from 0-15, with a score of 0 indicating that no intercourse was attempted in the last 4 weeks, 1= almost or little to no sanctification, 15= very highly satisfied.|baseline, 6 weeks, 12 weeks|||units on a scale||Standard Deviation|Mean
848752|NCT00245518|Primary|Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Erectile Function|IIEF Questionnaire is used for the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials. Erectile function is one domain, making up 6 out of 15 questions. The score ranges from 1-30, with the lowest score representing minimal erectile function.|baseline, 6 weeks, 12 weeks|||units on a scale||Standard Deviation|Mean
848753|NCT00245518|Primary|Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Total Score|IIEF Questionnaire is used for the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials. A score of 0-5 is awarded to each of the 15 questions which refer to the past 4 weeks only. The questions are split into the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction. The total score ranges from 6-75 with 6 being minimal erectile function and 75 representing maximal erectile function.|baseline, 6 weeks, 12 weeks|||units on a scale||Standard Deviation|Mean
848754|NCT00245518|Primary|Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Sanctification|The domains of satisfaction (3 items), is assessed using a five-point Likert-type scale ranging from “always” to “never” to generate the score, ranging from 3-15. The higher the number, the higher the level of satisfaction with sexual function.|baseline, 6 weeks, 12 weeks|||units on a scale||Standard Deviation|Mean
848755|NCT00245518|Primary|Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Arousal|The domains of arousal (1 item subscale of the WSFQ), is assessed using a five-point Likert-type scale ranging from “always” to “never” to generate the score for arousal. The higher the number (range 1-5), the more the participant is able to experience arousal.|baseline, 6 weeks, 12 weeks|||units on a scale||Standard Deviation|Mean
848756|NCT00245518|Primary|Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Erectile Function|The domain of erectile function/orgasm consists of 7 items. A five-point Likert-type scale ranging from “always” to “never” is used to generate a score, ranging from 7-35. Higher scores indicate increased erectile function/achievement of orgasm.|baseline, 6 weeks, 12 weeks|||units on a scale||Standard Deviation|Mean
848757|NCT00245518|Primary|Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Libido|The domain of sexual desire/libido consists of 6 items. A five-point Likert-type scale ranging from “always” to “never” is used to generate a score, ranging from 6-30. Higher scores indicate increased libido/sexual desire.|baseline, 6 weeks, 12 weeks|||units on a scale||Standard Deviation|Mean
848758|NCT00245518|Primary|Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Total Score|The WSFQ contains 17 items that assess the domains of sexual desire/libido (6 items), arousal (1 item), orgasm/erectile function (7 items), and satisfaction(3 items). A five-point Likert-type scale ranging from “always” to “never” is used to generate a total score and four domain scores. The possible range of total sexual function scores is 17 to 85. Higher scores indicate better sexual function.|baseline, 6 weeks, 12 weeks|||units on a scale||Standard Deviation|Mean
848759|NCT00245518|Primary|Cognition as Assessed by the Rex Complex Figure Test (RCFT), Delayed Recall|"The test measures recognition memory for the elements of the Rey complex figure, and assesses the respondent’s ability to use cues to retrieve information after 25-30 minutes. Scoring of drawings is based on the widely used 36-point scoring system. Each of the 18 scoring units is scored based on accuracy and placement criteria. Items of the figure can earn points:
Correct Image: placed properly (2 points), placed poorly (1 point)
Distorted or Incomplete Image, but recognizable: placed properly (1 point), placed poorly (1/2) point
Absent or not recognizable: 0 points
Scale ranges 0-36, with 36 representing maximum cognition ."|baseline, 6 weeks, 12 weeks|||units on a scale||Standard Deviation|Mean
848760|NCT00245518|Primary|Cognition as Assessed by the Rex Complex Figure Test (RCFT), Immediate Recall|"The test measures recognition memory for the elements of the Rey complex figure, and assesses the respondent’s ability to use cues to retrieve information. Scoring of drawings is based on the widely used 36-point scoring system. Each of the 18 scoring units is scored based on accuracy and placement criteria. Items of the figure can earn points:
Correct Image: placed properly (2 points), placed poorly (1 point)
Distorted or Incomplete Image, but recognizable: placed properly (1 point), placed poorly (1/2) point
Absent or not recognizable: 0 points
Scale ranges 0-36. with 36 being greatest cognitive function."|baseline, 6 weeks, 12 weeks|||units on a scale||Standard Deviation|Mean
848761|NCT00245518|Primary|Cognition as Assessed by the Grooved Pegboard Test (GPT) , Number of Non- Dominant Hand Drops|The GPT assesses eye–hand coordination and motor speed and thus requires sensory motor integration and a high level of motor processing. The test apparatus consists of a square metal surface (10.1 cm2) with a 5 × 5 matrix of keyhole shaped holes in various orientations. The task requires the examinee to pick up the keyhole shaped peg (3 mm in diameter) individually from the well just above the 5 × 5 matrix of holes from left to right and top to bottom as quickly as possible using the dominant hand. Because the holes are in various orientations, examinees must manipulate each peg in their hand (usually between the index finger and thumb) so that the peg aligns with the orientation of the hole.|baseline, 6 weeks, 12 weeks|||number of times peg dropped||Standard Deviation|Mean
848762|NCT00245518|Primary|Cognition as Assessed by the Grooved Pegboard Test (GPT) , Number of Dominant Hand Drops|The GPT assesses eye–hand coordination and motor speed and thus requires sensory motor integration and a high level of motor processing. The test apparatus consists of a square metal surface (10.1 cm2) with a 5 × 5 matrix of keyhole shaped holes in various orientations. The task requires the examinee to pick up the keyhole shaped peg (3 mm in diameter) individually from the well just above the 5 × 5 matrix of holes from left to right and top to bottom as quickly as possible using the dominant hand. Because the holes are in various orientations, examinees must manipulate each peg in their hand (usually between the index finger and thumb) so that the peg aligns with the orientation of the hole.|baseline, 6 weeks, 12 weeks|||number of times peg dropped||Standard Deviation|Mean
848763|NCT00245518|Primary|Cognition as Assessed by the Grooved Pegboard Test (GPT) , Non-dominant Hand Time (Seconds)|The GPT assesses eye–hand coordination and motor speed and thus requires sensory motor integration and a high level of motor processing. The test apparatus consists of a square metal surface (10.1 cm2) with a 5 × 5 matrix of keyhole shaped holes in various orientations. The task requires the examinee to pick up the keyhole shaped peg (3 mm in diameter) individually from the well just above the 5 × 5 matrix of holes from left to right and top to bottom as quickly as possible using the non-dominant hand. Because the holes are in various orientations, examinees must manipulate each peg in their hand (usually between the index finger and thumb) so that the peg aligns with the orientation of the hole.|baseline, 6 weeks, 12 weeks|||time in seconds||Standard Deviation|Mean
848764|NCT00245518|Primary|Cognition as Assessed by the Grooved Pegboard Test (GPT) , Dominant Hand Time (Seconds)|The GPT assesses eye–hand coordination and motor speed and thus requires sensory motor integration and a high level of motor processing. The test apparatus consists of a square metal surface (10.1 cm2) with a 5 × 5 matrix of keyhole shaped holes in various orientations. The task requires the examinee to pick up the keyhole shaped peg (3 mm in diameter) individually from the well just above the 5 × 5 matrix of holes from left to right and top to bottom as quickly as possible using the dominant hand. Because the holes are in various orientations, examinees must manipulate each peg in their hand (usually between the index finger and thumb) so that the peg aligns with the orientation of the hole. A faster time, indicates greater cognitive functioning.|baseline, 6 weeks, 12 weeks|||time in seconds||Standard Deviation|Mean
848765|NCT00245518|Primary|Cognitive Function as Assessed by the F-A-S Test|The F-A-S Test, a subtest of the Neurosensory Center Comprehensive Examination for Aphasia (NCCEA), is a measure of phonemic word fluency, which is a type of verbal fluency. It assesses phonemic fluency by requesting an individual to orally produce as many words as possible that begin with the letters F, A, and S within a prescribed time frame (1 minute)|baseline, 6 weeks, 12 weeks|||seconds||Standard Deviation|Mean
848766|NCT00245518|Primary|Cognitive Function as Assessed by the Hopkins Verbal Learning Test (HVLT), Percent Retained|The test consists 12 nouns, four words each from one of three semantic categories (e.g., precious gems, articles of clothing, vegetables, etc.), to be learned over the course of three learning trials. Approximately 20–25 min later, a delayed recall trial and a recognition trial are completed. The delayed recall requires free recall of any words remembered. The recognition trial is composed of 24 words, including the 12 target words and 12 false-positives, 6 semantically related, and 6 semantically unrelated. When scoring the HVLT, the three learning trials are combined to calculate a total recall score (0-36); the delayed recall trial creates the delayed recall score ( -12) ; the retention (%) score (0-100%) is calculated by dividing the delayed recall trial by the higher of learning trial 2 or 3; and the recognition discrimination index is comprised by subtracting the total number of false positives from the total number of true positives.A higher score= higher cognitive function.|baseline, 6 weeks, 12 weeks|||units on a scale||Standard Deviation|Mean
848767|NCT00245518|Primary|Cognitive Function as Assessed by the Hopkins Verbal Learning Test (HVLT), Recognition Discrimination Index|The test consists 12 nouns, four words each from one of three semantic categories (e.g., precious gems, articles of clothing, vegetables, etc.), to be learned over the course of three learning trials. Approximately 20–25 min later, a delayed recall trial and a recognition trial are completed. The delayed recall requires free recall of any words remembered. The recognition trial is composed of 24 words, including the 12 target words and 12 false-positives, 6 semantically related, & 6 semantically unrelated. When scoring the HVLT, the three learning trials are combined to calculate a total recall score (0-36); the delayed recall trial creates the delayed recall score ( -12) ; the retention (%) score (0-100%) is calculated by dividing the delayed recall trial by the higher of learning trial 2 or 3; and the recognition discrimination index is comprised by subtracting the total number of false positives from the total number of true positives. A higher score= higher cognitive function.|baseline, 6 weeks, 12 weeks|||units on a scale||Standard Deviation|Mean
848768|NCT00245518|Primary|Cognitive Function as Assessed by the Hopkins Verbal Learning Test (HVLT), Total Recall Score|The test consists 12 nouns, four words each from one of three semantic categories (e.g., precious gems, articles of clothing, vegetables, etc.), to be learned over the course of three learning trials. Approximately 20–25 min later, a delayed recall trial and a recognition trial are completed. The delayed recall requires free recall of any words remembered. The recognition trial is composed of 24 words, including the 12 target words and 12 false-positives, 6 semantically related, & 6 semantically unrelated. When scoring the HVLT, the three learning trials are combined to calculate a total recall score (0-36); the delayed recall trial creates the delayed recall score ( -12) ; the retention (%) score (0-100%) is calculated by dividing the delayed recall trial by the higher of learning trial 2 or 3; and the recognition discrimination index is comprised by subtracting the total number of false positives from the total number of true positives. A higher score = higher cognition.|baseline, 6 weeks, 12 weeks|||units on a scale||Standard Deviation|Mean
848769|NCT00245518|Primary|Cognitive Function as Assessed by the National Adult Reading Test (NART)|the NART estimates intelligence levels of English-speaking patients. It consists of 50 short words with irregular spelling or phonetic appearance which the participant must read and pronounce. The higher the score, the higher number of correct responses. Scores are 0-50.|baseline, 6 weeks, 12 weeks|||units on a scale||Standard Deviation|Mean
857722|NCT00156013|Secondary|Toxicity|most common toxicity|5 years|||Participants|||Count of Participants
857723|NCT00156013|Primary|Phase II Overall Response||5 years|||Participants|||Count of Participants
857724|NCT00156013|Primary|Phase I Maximum Tolerated Dose|Maximum Tolerated Dose for Clofarabine. Cohorts of 3 patients each will receive doses of clofarabine increased in increments as follows: 4, 6, 8, 10, 12,…etc mg/m2/day for 5 days. The dose level immediately below the MTD will be used to treat patients in the Phase II part of the study. Starting dose of 4 mg/m2.|days 1 -28, maximum 6 cycles|Per protocol guidelines for accrual to the cohorts.||mg/m^2|||Number
857733|NCT00116428|Secondary|Percentage of Subjects Responded to Each of the Four Health Status Categories.|At the 2 year follow-up visit, Atrial Fibrillation recurrence was assessed by subject interview without documentation.|During the two years of post procedure|Subjects who completed the two-year health survey.||Percentage of Participants|||Number
858607|NCT00742963|Primary|Maximum Tolerated Dose (MTD) Measured of TH-302 When Used in Combination With Doxorubicin and Prophylactic Growth Factor Support in Subjects With Advanced Soft Tissue Sarcoma||Two years|||mg/m2|||Number
858608|NCT00742859|Secondary|Exposure-adjusted Incidence Rate of Any Bleeding (Major, Clinically Relevant Non-major, or Minimal)|The time to the first occurrence of any bleeding event. This was presented as the exposure adjusted incidence rate which was calculated as number of subjects experiencing the event divided by total person years across all subjects, where if a patient experiencing the event, year was from first dose date to the first occurrence of the event, and to last study date if not. The confidence interval was calculated via the exact Poisson distribution.|A maximum of 1 year|All randomized patients who took at least 1 dose of study medication after randomization.||Number of Patients per 100 Patient years||95% Confidence Interval|Number
858609|NCT00742859|Primary|Exposure-adjusted Incidence Rate of Major or Clinically Relevant Non-major Bleeding Episode|The primary endpoint is the time to the first occurrence of major or clinically relevant non-major bleeding. This was presented as the exposure adjusted incidence rate which was calculated as number of subjects experiencing the event divided by total person years across all subjects, where if a patient experiencing the event, year was from first dose date to the first occurrence of the event, and to last study date if not. The confidence interval was calculated via the exact Poisson distribution.|A maximum of 1 year|All randomized patients who took at least 1 dose of study medication after randomization.||Number of Patients per 100 Patient years||95% Confidence Interval|Number
858610|NCT00740870|Secondary|Functional Assessment (NYHA Classification)|Improvement in Functional Assessment (NYHA Classification) at 6 months post implant.|6 Months|The Implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours and had paired data from pre-implant to 6 months post-implant.||Participants|||Count of Participants
858611|NCT00740870|Secondary|Kaplan-Meier Freedom From Death (All-cause, Procedural and Device-related)|Deaths (all-cause, procedural and device-related) at 5 years|5 years|The catheterized cohort consists of all subjects who underwent catheterization for possible implantation of the Melody TPV.||percentage of subjects||95% Confidence Interval|Number
858612|NCT00740870|Secondary|Kaplan-Meier Freedom From Surgical Replacement of the RVOT Conduit|Freedom From Surgical Replacement of the RVOT Conduit|5 years|The Implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.||percentage of subjects||95% Confidence Interval|Number
858613|NCT00740870|Secondary|Kaplan-Meier Freedom From Catheter Re-intervention on TPV|All Catheter Re-intervention on TPV at 5 years|5 years|The Implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.||percentage of subjects||95% Confidence Interval|Number
858614|NCT00740870|Secondary|Kaplan-Meier Freedom From Major Stent Fracture at 5 Years|Major stent fracture is defined as a stent fracture requiring intervention to prevent permanent impairment of a body function or permanent damage to a body structure.|5 years|The Implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.||percentage of subjects||95% Confidence Interval|Number
858615|NCT00740870|Secondary|Serious Device-related Adverse Event|A device-related event is defined as an event that is associated with the TPV by the chronology or physiology and was caused by the the TPV (e.g. embolization of the TPV and any adverse events which follow).|5 years|The implanted cohort consists of all subjects who underwent catheterization and a Melody TPV was implanted.||percentage of subjects|||Number
858616|NCT00740870|Secondary|Serious Procedural Adverse Event (AE)|A procedure-related event is defined as an event that is associated with the implant procedure by the chronology or physiology and was caused by the implant procedure (e.g. rupture of the conduit or damage to an intra-cardiac or intravascular structure by the delivery system).|5 years|The catheterized cohort consists of all subjects who underwent catheterization for possible implantation of the Melody TPV.||percentage of subjects|||Number
858617|NCT00740870|Secondary|Procedural Success|"Procedural success is a composite outcome defined as:
Melody TPV fixated within the desired location
Right Ventricle (RV) - Pulmonary Artery (PA) peak-to-peak gradient (measured in the catheterization lab) less than 35 mmHg post-implant
Less than mild pulmonary regurgitation by angiography post-implant
Free of explant at 24 hours post-implant"|Within 24 Hours post implant|The attempted implant cohort consists of all subjects who underwent catheterization and a Melody TPV implantation was attempted (Melody TPV valve opened).||percentage of subjects|||Number
858618|NCT00740870|Primary|Kaplan-Meier Freedom From TPV Dysfunction|"To assess whether long-term functionality of implantation of the Medtronic Melody TPV at 5 years is no worse than the historical control established through literature review. This study is designed to test the null hypothesis that the true freedom from TPV dysfunction at 5 years after Melody implantation (PMelody) is less than or equal to 36% (PControl). To reject the null hypothesis means that freedom from TPV dysfunction at 5 years after Melody implantation (PMelody) is greater than 36% (PControl). The null (H0) and alternative (HA) hypotheses are written as follows:H0: PMelody ≤ PControl and HA: PMelody > PControl. TPV dysfunction is a composite outcome defined as the following:
Hemodynamic dysfunction of the TPV
Moderate or greater pulmonary regurgitation, and/or
Mean Right Ventricular Outflow Tract (RVOT) gradient greater than 40 mmHg
RVOT reoperation for conduit dysfunction or device-related reasons
Catheter re-intervention on the TPV"|5 years|The Implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.||percentage of subjects||95% Confidence Interval|Number
858619|NCT00731731|Secondary|Incidence of Adverse Events, as Per NCI CTCAE Version 3.0 (Phase II)|"The maximum grade for each type of treatment-related adverse event will be recorded for each patient, and frequency tables for each arm will be reviewed to determine patterns. In addition, we will review all adverse event data that is graded as 3, 4, or 5 and classified as either unrelated or unlikely to be related to study treatment in the event of an actual relationship developing."|Up to 5 years|||participants evaluable for toxicity|||Number
858620|NCT00731731|Secondary|Time to Tumor Progression (Phase II)|Progression free survival time will be defined from date of registration to date of progression or death.|Up to 5 years|||months||95% Confidence Interval|Median
859148|NCT01141712|Secondary|Cumulative Incidence of Neutrophil Recovery|Neutrophil recovery is defined as two consecutive days of absolute neutrophil count (ANC) > 500 neutrophils/μL following the expected nadir.|Day 28|||percentage of participants||95% Confidence Interval|Number
850249|NCT01856686|Secondary|Frontal Midline Theta Activity- Frequency at 3 Months|Frontal midline theta activity- frequency during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.|3 months|||Hz||Standard Deviation|Mean
850250|NCT01856686|Secondary|Mu Wave Frequency at 3 Months|Mu wave frequency during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.|3 months|||Hz||Standard Deviation|Mean
850251|NCT01856686|Other Pre-specified|Weight at 3 Months|Weight after 3 months of dietary approach.|3 months|||kilograms||Standard Deviation|Mean
850252|NCT01856686|Secondary|Parietal Alpha Waves-frequency at 3 Months|Parietal alpha waves-frequency during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.|3 months|||Hz||Standard Deviation|Mean
849998|NCT02675634|Primary|Fit to Body|"Subjects will evaluate the fit to body for each product by answering the question how was the baseplates ability to fit the body contours in the area around the stoma? The question is answered using an ordinal 5 point scale ranging from very poor to very good. The result shown below shows the fraction of subject who answered 'Good' or' Very Good' to the question."|14 +/- 2 days|||percentage of good or very good|||Number
849999|NCT02651194|Secondary|Percentage of Participants With Post-treatment Relapse|Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment, excluding reinfection.|From the end of treatment through 12 weeks after the last dose of study drug|All participants who received at least 1 dose of study drug, completed treatment, and had HCV RNA <LLOQ at the final treatment visit.||percentage of participants||95% Confidence Interval|Number
850000|NCT02651194|Secondary|Percentage of Participants With On-treatment Virologic Failure|On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.|up to 12 weeks|All participants who received at least 1 dose of study drug (ITT population).||percentage of participants||95% Confidence Interval|Number
850001|NCT02651194|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug|12 weeks after the last actual dose of study drug|Intent-to-treat population: all participants who received at least 1 dose of study drug; participants with missing data after backwards imputation were imputed as nonresponders.||percentage of participants||95% Confidence Interval|Number
850009|NCT02482805|Primary|Salivary Testosterone Levels|Saliva sample taken before posture manipulation and 20 minutes after. Outcome is the change from pre- to post-manipulation in testosterone levels.|Baseline and 20 minutes after posture manipulation|||pg/mL||Standard Deviation|Mean
850010|NCT02482805|Primary|Subjective Units of Distress Scale (SUDs)|"Peak (max) SUDS ratings (0 to 100 scale) during treatment exposure and 1 week post-treatment exposure.
Peak Subjective Units of Distress Scale (SUDS) is the maximum amount of fear experienced rated on a 0 to 100 point scale, where 0 indicates no anxiety and 100 indicates the maximum level of anxiety."|Change from baseline to 1 week|8 individuals did not complete the post-treatment exposure; accordingly the analyses were conducted with only 66 individuals (versus the total sample size of 73) who had complete data.||units on a scale||Standard Deviation|Mean
850011|NCT02482805|Primary|LSAS-performance Subscale|"Liebowitz Social Anxiety Scale (LSAS)-Performance Subscale at pre- and 1-week post-treatment.
The Liebowitz Social Anxiety Scale (LSAS) - Performance Subscale is a subscale of a common measure of social anxiety symptom severity. This subscale consists of only 13 (of the total 24) items related to performance situations. Participants rate both their fear (0 to 3) and avoidance (0 to 3) of these 13 situations, where higher scores indicate worse social anxiety severity. The minimum possible score on this subscale is 0 and the maximum possible score is 78."|Change from baseline to 1 week|4 individuals did not complete LSAS at post-treatment; accordingly the analyses were conducted with only 69 individuals (versus the total sample size of 73) who had complete data.||units on a scale||Standard Deviation|Mean
850026|NCT02442284|Secondary|Percentage of Participants With Post-treatment Relapse|Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment.|From the end of treatment through 12 weeks after the last dose of study drug|All participants who received at least 1 dose of study drug, completed treatment, and had HCV RNA <LLOQ at the final treatment visit.||percentage of participants||95% Confidence Interval|Number
850012|NCT02474901|Other Pre-specified|Number of Participants With PCR-diagnosed Influenza and Clinically-diagnosed Influenza Like Illness.|Compare numbers of participants with influenza diagnosed by PCR and with clinically-diagnosed influenza between the two groups. Data was taken from Influenza Infection Questionnaires #1 and #2. The last questionnaire (#2) was administered between May 15 and June 10, 2014 (after the vaccine). Data is reported as PCR-confirmed influenza and clinically-diagnosed influenza (subject told had influenza without confirmatory testing).|August 2014 through June 2014, 11 months|Number of participants analyzed reflects the number of subjects who participated in the end-of-season interview.||Participants|||Count of Participants
850013|NCT02474901|Secondary|Number of Participants Reaching Seroprotection (HAI ≥ 40) Within the HIV-positive and Control Groups.|The investigators will measure hemagglutinin inhibition (HAI) on blood samples #2 (14-21 days after vaccination) for all participants. The investigators will also compare the number of participants reaching HAI ≥ 40 for each virus sub-type contained in the vaccine.|14-21 days|The total number of participants analyzed reflect the number of subjects for whom there was a blood sample from the 4th visit at day 14-21.||Participants|||Count of Participants
850014|NCT02474901|Secondary|Number of Participants With Adverse Events Within 14 Days After Vaccination|The investigators will compare the number of adverse events (AE) reported by AE category within 14 days after vaccination as reported by each participant. Data will reflect whether a participant ever reported the AE, and not the number of times the AE was reported.|14 days after vaccination for AEs; up to 30 days for unscheduled visits|||Participants|||Count of Participants
850015|NCT02474901|Primary|Number of Participants With Shedding for at Least One of the Influenza Strains Included in the QLAIV Vaccine at Each of the 4 Study Visits, Days 0 (Baseline), 2-5, 7-10, and 14-21 in HIV-positive and Control Groups.|Measure PCR positivity for any of the influenza subtypes included in QLAIV at visit 1 (day 0), visit 2 (days 2-5), visit 3 (days 7-10) and visit 4 (days 14-21). Compare number of participants with shedding for any subtype in each patient group. (The study was powered based on the 7-10 day data.)|day 0-21 post-vaccine|Subjects with data for any of the visits||Participants|||Count of Participants
850016|NCT02474901|Primary|Number of Participants With Shedding for at Least One of the Influenza Strains Included in the QLAIV in the First 21 Days After Vaccine Administration Days in HIV-positive and Control Groups.|Measure PCR positivity for any of the influenza subtypes included in QLAIV between baseline (day 0) and the last study visit at 14-21 days after vaccine. Compare number of participants with PCR positivity for any of the vaccine-strain influenza virus strains in each patient group.|21 days|HIV-infected and uninfected recipients of QLAIV; one HIV-uninfected subject was lost-to-follow-up after the first follow-up visit following vaccination.||Participants|||Count of Participants
850025|NCT02442284|Secondary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) Among Participants With Ongoing Psychiatric Disorders|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug. Participants with missing data after backwards imputation were imputed as nonresponders.|12 weeks after the last actual dose of study drug|All participants who received at least 1 dose of study drug (ITT population) and with ongoing psychiatric disorders.||percentage of participants||95% Confidence Interval|Number
850027|NCT02442284|Secondary|Percentage of Participants With Virologic Failure During Treatment|On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment.|up to 12 weeks (for 12-week treatment group) or up to 24 weeks (for 24-week treatment group|Intent-to-treat (ITT) population: all participants who received at least 1 dose of study drug.||percentage of participants||95% Confidence Interval|Number
850028|NCT02442284|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug. Participants with missing data after backwards imputation were imputed as nonresponders.|12 weeks after the last actual dose of study drug|Intent-to-treat (ITT) population: all participants who received at least 1 dose of study drug.||percentage of participants||95% Confidence Interval|Number
850041|NCT02345642|Primary|Peak Venous Velocity|Ultrasound of the venous system just below the saphenofemoral junction to assess the venous velocity will be taken before and after application the VenaFlow and the ActiveCare+S.F.T pneumatic compression devices. Change from Baseline in Peak Venous Velocity 30 minutes after Device is applied is recorded.|Change from Baseline in Peak Venous Velocity 30 minutes after Device is Applied|||cm/s||Full Range|Mean
850042|NCT02279082|Primary|Number of Participants With Treatment Emergent Adverse Events||6 months|||Participants|||Count of Participants
850043|NCT02277769|Secondary|Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Treatment Discontinuation From Baseline Through Week 16|Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to the end of study [Week 28]). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.|Baseline up to Week 16|Safety analysis set (SAF) which included all randomized participants who received any study drug, and was analyzed as treated.||percentage of participants|||Number
850044|NCT02277769|Secondary|Percentage of Participants With Treatment Emergent Serious Adverse Events (TESAEs) From Baseline Through Week 16|Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to the end of study [Week 28]). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.|Baseline up to Week 16|Safety analysis set which included all randomized participants who received any study drug, and was analyzed based on the treatment received.||percentage of participants|||Number
850055|NCT02277769|Secondary|Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score to Week 16|The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.|Baseline to Week 16|Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.||percent change||Standard Deviation|Mean
850045|NCT02277769|Secondary|Percentage of Participants With Skin Infection Treatment Emergent Adverse Events (TEAEs) Requiring Systemic Treatment|Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to the end of study [Week 28]). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs. Statistical significance in the hierarchical testing of secondary hypotheses was broken at this endpoint. Therefore, subsequent secondary efficacy endpoints were not tested for statistical significance.|Baseline up to Week 16|Safety analysis set (SAF) which included all randomized participants who received any study drug, and was analyzed as treated.||percentage of participants|||Number
850046|NCT02277769|Secondary|Percent Change From Baseline in Weekly Average of Peak Daily Pruritus NRS Score to Week 2|Pruritus NRS was an assessment tool that was used to report the intensity of a participant’s pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 – 10 [0 = no itch; 10 = worst itch imaginable]).|Baseline to Week 2|Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.||percent change||Standard Deviation|Mean
850047|NCT02277769|Secondary|Percent Change From Baseline in Global Individual Signs Score (GISS) to Week 16|Individual components of the AD lesions (erythema, infiltration/ papulation, excoriations, and lichenification) were rated globally (each assessed for the whole body, not by anatomical region) on a 4-point scale (0= none, 1= mild, 2= moderate and 3= severe) using the EASI severity grading criteria. Total score ranges from 0 (absent disease) to 12 (severe disease).|Baseline to Week 16|Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.||percent change||Standard Deviation|Mean
850048|NCT02277769|Secondary|Change From Baseline in Hospital Anxiety Depression Scale (HADS) to Week 16|HADS is a fourteen item scale. Seven of the items relate to anxiety and seven items relate to depression. Each item on the questionnaire is scored from 0 (minimum score) - 3 (maximum score) and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression. Cut-offs for identifying psychiatric distress has been reported as 7 to 8 for possible presence, 10 to 11 for probable presence, and 14 to 15 for severe anxiety or depression.|Baseline to Week 16|Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.||units on a scale||Standard Deviation|Mean
850049|NCT02277769|Secondary|Change From Baseline in Patient Oriented Eczema Measure (POEM) to Week 16|The POEM is a 7-item questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease) (high score indicative of poor quality of life [QOL]).|Baseline to Week 16|Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.||units on a scale||Standard Deviation|Mean
850050|NCT02277769|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 16|The DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life (QOL). The 10 questions assessed QOL over the past week, with an overall scoring of 0 (absent disease) to 30 (severe disease); a high score was indicative of a poor QOL.|Baseline to Week 16|Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.||units on a scale||Standard Deviation|Mean
850051|NCT02277769|Secondary|Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Score to Week 16|SCORAD is a clinical tool for assessing the severity of AD developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index). Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology (Basel) 186 (1): 23–31. 1993. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease).|Baseline to Week 16|Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.||percent change||Standard Deviation|Mean
850052|NCT02277769|Secondary|Change From Baseline in Percent Body Surface Area (BSA) to Week 16|BSA affected by AD was assessed for each section of the body (the possible highest score for each region was: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]). It was reported as a percentage of all major body sections combined.|Baseline to Week 16|Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.||percentage of body surface area||Standard Deviation|Mean
850053|NCT02277769|Secondary|Percentage of Participants With Eczema Area and Severity Index-90 (EASI-90) (≥90% Improvement From Baseline) at Week 16|The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-90 responders were the participants who achieved ≥90% overall improvement in EASI score from baseline to Week 16. Values after first rescue treatment were set to missing and participants with missing EASI-90 scores at Week 16 were considered as non-responders.|Week 16|Full analysis set (FAS) included all randomized participants.||percentage of particpants|||Number
850054|NCT02277769|Secondary|Percentage of Participants With Eczema Area and Severity Index-50 (EASI-50) (≥50% Improvement From Baseline) at Week 16|The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-50 responders were the participants who achieved ≥50% overall improvement in EASI score from baseline to Week 16. Values after first rescue treatment were set to missing and participants with missing EASI-50 scores at Week 16 were considered as non-responders.|Week 16|Full analysis set (FAS) included all randomized participants.||percentage of participants|||Number
850056|NCT02277769|Secondary|Change From Baseline in Peak Daily Pruritus Numerical Rating Scale (NRS) Score to Week 16|Pruritus NRS was an assessment tool that was used to report the intensity of a participant’s pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 – 10 [0 = no itch; 10 = worst itch imaginable]).|Baseline to Week 16|Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.||units on a scale||Standard Deviation|Mean
850057|NCT02277769|Secondary|Percentage of Participants With Improvement (Reduction ≥4 Points) of Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 2|Pruritus NRS was an assessment tool that was used to report the intensity of a participant’s pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 – 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 2 were reported. Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 2 were considered as non-responders.|Baseline to Week 2|Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with baseline peak pruritus NRS ≥4.||percentage of participants|||Number
850058|NCT02277769|Secondary|Percentage of Participants With Improvement (Reduction ≥4 Points) of Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 4|Pruritus NRS was an assessment tool that was used to report the intensity of a participant’s pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 – 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 4 were reported. Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 4 were considered as non-responders.|Baseline to Week 4|Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with baseline peak pruritus NRS ≥4.||percentage of participants|||Number
850059|NCT02277769|Secondary|Percent Change From Baseline in Weekly Average of Peak Pruritus Numerical Rating Scale (NRS) Score to Week 16|Pruritus NRS was an assessment tool that was used to report the intensity of a participant’s pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 – 10 [0 = no itch; 10 = worst itch imaginable]).|Baseline to Week 16|Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.||percent change||Standard Deviation|Mean
850060|NCT02277769|Secondary|Percentage of Participants With Improvement (Reduction ≥3 Points) in Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16|Pruritus NRS was an assessment tool that was used to report the intensity of a participant’s pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 – 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥3 points from baseline in weekly average of peak daily pruritus NRS score at Week 16 were reported. Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 16 were considered as non-responders.|Baseline to Week 16|Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with baseline peak pruritus NRS ≥3.||percentage of participants|||Number
850061|NCT02277769|Secondary|Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16|Pruritus NRS was an assessment tool that was used to report the intensity of a participant’s pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 – 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 16 were reported. Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 16 were considered as non-responders.|Baseline to Week 16|Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with baseline peak pruritus NRS ≥4.||percentage of participants|||Number
850062|NCT02277769|Secondary|Percentage of Participants With Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) at Week 16|The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-75 responders were the participants who achieved ≥75% overall improvement in EASI score from baseline to Week 16. Values after first rescue treatment use were set to missing and participants with missing EASI score at Week 16 were considered as non-responders.|Week 16|Full analysis set included all randomized participants.||percentage of participants|||Number
850063|NCT02277769|Primary|Percentage of Participants With Investigator’s Global Assessment (IGA) Score of “0” or “1” and Reduction From Baseline of ≥2 Points at Week 16|IGA is an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response is an IGA score of 0 (clear) or 1 (almost clear). Participants with IGA score of “0” or “1” and a reduction from baseline of ≥2 points at Week 16 were reported. Values after first rescue treatment were set to missing and participants with missing IGA scores at Week 16 were considered as non-responders.|Week 16|Full analysis set included all randomized participants.||percentage of participants|||Number
852153|NCT00855413|Secondary|Maximum Etravirine Exposure in Semen Among Participants Who Consented to an Optional Collection of Semen||Weeks 0-4 and weeks 12, 48|Four participants consented to provide a semen sample for measurement of drug levels.||ng/mL|||Number
850253|NCT01856686|Primary|Occipital Alpha Brainwaves Amplitudes at 3 Months|occipital alpha waves amplitudes during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.|3 months|||microvolts||Standard Deviation|Mean
850115|NCT02197247|Secondary|Assessment of Tss,Max for Rifampicin|Rate and extent of absorption of rifampicin by assessment of tss,max. AZD9291 dosing in combination with rifampicin (Period 2).|Samples collected on Day 49 (following AZD9291 and rifampicin) at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.||h||Full Range|Median
850114|NCT02197247|Secondary|Assessment of Css,Min for AZD9291, and AZ5104 and AZ7550 (Metabolites)|Rate and extent of absorption of AZD9291, and AZ5104 and AZ7550 (metabolites) by assessment of minimum plasma concentration at steady state (Css,min). AZD9291 dosing alone and in combination with rifampicin (all periods).|Samples collected on Day 28 and 77 (following AZD9291 alone) and Day 49 (following AZD9291 and rifampicin) at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.||nM||Geometric Coefficient of Variation|Geometric Mean
850106|NCT02240654|Primary|The Proportion of Potential Off-label Use Estimated Among New Users of Dabigatran Etexilate in Each of the Data Sources.|"Definition of off-label use of oral dabigatran etexilate (DE) was based on use for a disease/medical condition other than labelled indications,asdescribed/documented in the data source used in the respective countries, taking into account the changes in the label within the study period. The prevalence of potential off-label use among new users of DE during the overall study period is calculated as the proportion of patients meeting the definition of off-label use by dividing the number of index prescriptions that represented off-label use by the total number of index prescriptions.
Two definitions were applied to estimate potential off-label use based on either recorded diagnoses or proxies: a broad definition of on-label prescribing using codes for disease indication e.g.atrial fibrillation(AF) and a restrictive definition excluding patients with conditions for which the drug is not indicated e.g.valvular AF.
SPAF:Stroke & systemic embolism in adult patients with non-valvular AF"|Time period since approval of the SPAF indication in, France: 01 August 2011 to 30 June 2014; Denmark: 01 August 2011 to 30 November 2013; UK: 01 August 2011 to 30 August 2015.|The study population included new users of dabigatran etexilate in the study period. New users were defined as those patients who initiated treatment with dabigatran etexilate during the study period and who had not used it during the previous year.||percentage of participants||95% Confidence Interval|Number
850109|NCT02197247|Secondary|Assessment of the Metabolic Ratios of AUCtau for AZ5104 and AZ7550 (MRAUCtau)|Assessment of the metabolite to parent ratio (calculated as AZ5104 to AZD9291 and AZ7550 to AZD9291) for AUCtau (MRAUCtau). AZD9291 dosing alone and in combination with rifampicin (all periods).|Samples collected on Day 28 and 77 (following AZD9291 alone) and Day 49 (following AZD9291 and rifampicin) at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.||Ratio||Geometric Coefficient of Variation|Geometric Mean
850110|NCT02197247|Secondary|Assessment of the Metabolic Ratios of Css,Max for AZ5104 and AZ7550 (MRCss,Max)|Assessment of the metabolite to parent ratio (calculated as AZ5104 to AZD9291 and AZ7550 to AZD9291) for Css,max (MRCss,max). AZD9291 dosing alone and in combination with rifampicin (all periods).|Samples collected on Day 28 and 77 (following AZD9291 alone) and Day 49 (following AZD9291 and rifampicin) at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.||Ratio||Geometric Coefficient of Variation|Geometric Mean
850111|NCT02197247|Secondary|Assessment of CLss/F for Rifampicin|Rate and extent of absorption of rifampicin by assessment of CLss/F. AZD9291 dosing in combination with rifampicin (Period 2).|Samples collected on Day 49 (following AZD9291 and rifampicin) at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.|||L/h||Geometric Coefficient of Variation|Geometric Mean
850112|NCT02197247|Secondary|Assessment of CLss/F for AZD9291|Rate and extent of absorption of AZD9291 by assessment of the apparent plasma clearance following oral administration and multiple dosing (CLss/F). AZD9291 dosing alone and in combination with rifampicin (all periods).|Samples collected on Day 28 and 77 (following AZD9291 alone) and Day 49 (following AZD9291 and rifampicin) at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.|||Litre per hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
850113|NCT02197247|Secondary|Assessment of Css,Min for Rifampicin|Rate and extent of absorption of rifampicin by assessment of minimum plasma concentration at steady state (Css,min). AZD9291 dosing in combination with rifampicin (Period 2).|Samples collected on Day 49 (following AZD9291 and rifampicin) at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
850116|NCT02197247|Secondary|Assessment of Tss,Max for AZD9291, and AZ5104 and AZ7550 (Metabolites)|Rate and extent of absorption of AZD9291, and AZ5104 and AZ7550 (metabolites) by assessment of time to reach maximum plasma concentration at steady state (tss,max). AZD9291 dosing alone and in combination with rifampicin (all periods).|Samples collected on Day 28 and 77 (following AZD9291 alone) and Day 49 (following AZD9291 and rifampicin) at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.||h||Full Range|Median
850117|NCT02197247|Secondary|Assessment of AUCtau for Rifampicin|Rate and extent of absorption of rifampicin by assessment of AUCtau. AZD9291 dosing in combination with rifampicin (Period 2).|Samples collected on Day 49 (following AZD9291 and rifampicin) at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
850118|NCT02197247|Secondary|Assessment of AUCtau for AZ7550 (Metabolite)|Rate and extent of absorption of AZ7550 (metabolite) by assessment of AUCtau. AZD9291 dosing alone and in combination with rifampicin (all periods).|Samples collected on Day 28 and 77 (following AZD9291 alone) and Day 49 (following AZD9291 and rifampicin) at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.||nM*h||Geometric Coefficient of Variation|Geometric Mean
850119|NCT02197247|Secondary|Assessment of AUCtau for AZ5104 (Metabolite)|Rate and extent of absorption of AZ5104 (metabolite) by assessment of AUCtau. AZD9291 dosing alone and in combination with rifampicin (all periods).|Samples collected on Day 28 and 77 (following AZD9291 alone) and Day 49 (following AZD9291 and rifampicin) at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.||nM*h||Geometric Coefficient of Variation|Geometric Mean
850120|NCT02197247|Secondary|Assessment of AUCtau for AZD9291 Before and After Rifampicin|Rate and extent of absorption of AZD9291 by assessment of AUCtau. AZD9291 alone before rifampicin (Period 1) and AZD9291 alone after rifampicin (Period 3).|Samples collected on Day 28 and 77 following AZD9291 alone at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.||nM*h||Geometric Coefficient of Variation|Geometric Mean
850121|NCT02197247|Secondary|Assessment of Css,Max for Rifampicin|Rate and extent of absorption of rifampicin by assessment of Css,max. AZD9291 dosing in combination with rifampicin (Period 2).|Samples collected on Day 49 (following AZD9291 and rifampicin) at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.||nanogram per millilitre (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
850122|NCT02197247|Secondary|Assessment of Css,Max for AZ7550 (Metabolite)|Rate and extent of absorption of AZ7550 (metabolite) by assessment of Css,max. AZD9291 dosing alone and in combination with rifampicin (all periods).|Samples collected on Day 28 and 77 (following AZD9291 alone) and Day 49 (following AZD9291 and rifampicin) at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.||nM||Geometric Coefficient of Variation|Geometric Mean
850123|NCT02197247|Secondary|Assessment of Css,Max for AZ5104 (Metabolite)|Rate and extent of absorption of AZ5104 (metabolite) by assessment of Css,max. AZD9291 dosing alone and in combination with rifampicin (all periods).|Samples collected on Day 28 and 77 (following AZD9291 alone) and Day 49 (following AZD9291 and rifampicin) at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.||nM||Geometric Coefficient of Variation|Geometric Mean
850124|NCT02197247|Secondary|Assessment of Css,Max for AZD9291 Before and After Rifampicin|Rate and extent of absorption of AZD9291 by assessment of Css,max. AZD9291 alone before rifampicin (Period 1) and AZD9291 alone after rifampicin (Period 3).|Samples collected on Day 28 and 77 following AZD9291 alone at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.||nM||Geometric Coefficient of Variation|Geometric Mean
850125|NCT02197247|Primary|Assessment of Area Under the Plasma Concentration-time Curve During the Dosing Interval for AZD9291 After Dosing Alone and in Combination With Rifampicin (AUCtau)|Rate and extent of absorption of AZD9291 by assessment of AUCtau. AZD9291 doses were first without, then with rifampicin (Periods 1 and 2, respectively).|Samples collected on Day 28 following AZD9291 alone and Day 49 following AZD9291 and rifampicin at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.||nM * hour (nM*h)||Geometric Coefficient of Variation|Geometric Mean
850126|NCT02197247|Primary|Assessment of Maximum Plasma Concentration for AZD9291 After Dosing Alone and in Combination With Rifampicin (Css,Max)|Rate and extent of absorption of AZD9291 by assessment of maximum plasma concentration at steady state (Css,max). AZD9291 doses were first without, then with rifampicin (Periods 1 and 2, respectively).|Samples collected on Day 28 following AZD9291 alone and Day 49 (following AZD9291 and rifampicin) at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.||nanomolar (nM)||Geometric Coefficient of Variation|Geometric Mean
850132|NCT02105688|Secondary|Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After the End of All Study Therapy (SVR24): Immediate Treatment Arm|Blood is drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® AmpliPrep/COBAS® Taqman HCV Test, v2.0, which has an LLOQ of 15 IU/mL. SVR24 is defined as HCV RNA <LLOQ at 24 weeks after the end of all study therapy. The Clopper-Pearson method is used to construct 95% confidence intervals for the SVR24 rate. As pre-specified in the protocol, the Deferred Treatment Arm will not be included in the secondary efficacy analysis.|24 weeks after end of all therapy (Study Week 36)||05/2019||||
850133|NCT02105688|Primary|Percentage of Participants Discontinued From Study Therapy Due to AEs During the DB Treatment Period|An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol -specified procedure, whether or not considered related to the medicinal product or protocol -specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an adverse event. For this study, the primary safety analysis compared the safety data in the Immediate Treatment Arm during the double-blinded treatment period to those of the Deferred Treatment Arm during the double-blinded placebo treatment period.|DB Treatment period (up to 12 weeks)|APaT Population; all participants who received at least one dose of study treatment.||percentage of participants|||Number
850134|NCT02105688|Primary|Percentage of Participants Experiencing at Least One Adverse Event (AE) During the DB Treatment Period and First 14 Follow-up Days|An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol -specified procedure, whether or not considered related to the medicinal product or protocol -specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an adverse event. For this study, the primary safety analysis compared the safety data in the Immediate Treatment Arm during the double-blinded treatment period to those of the Deferred Treatment Arm during the double-blinded placebo treatment period.|DB Treatment period plus first 14 follow-up days (up to 14 weeks)|All Participants as Treated (APaT) Population; all participants who received at least one dose of study treatment.||percentage of participants|||Number
850135|NCT02105688|Primary|Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After the End of All Study Therapy (SVR12): Immediate Treatment Arm|Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS® AmpliPrep/COBAS® Taqman HCV Test, v2.0, which had a lower limit of quantification of 15 IU/mL. SVR12 was defined as HCV RNA below the lower limit of detection (<LLOQ) at 12 weeks after the end of all study therapy. The Clopper-Pearson method was used to construct 95% confidence intervals for the SVR12 rate. As pre-specified in the protocol, the Deferred Treatment Arm was not included in the primary efficacy analysis.|12 weeks after end of all therapy (Study Week 24)|Modified FAS (mFAS): All randomized participants in the Immediate Treatment Arm receiving ≥1 dose of study treatment and excluding participants for study discontinuation for reasons unrelated to treatment regimen, response to HCV treatment, or BL genotype (GT)2, GT3, or GT5. Deferred Treatment Arm was not included in primary efficacy analysis.||percentage of participants||95% Confidence Interval|Number
850254|NCT01856686|Secondary|Occipital Alpha Waves-frequency at 3 Months|occipital alpha waves-frequency during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.|3 months|||Hz||Standard Deviation|Mean
850255|NCT01856686|Primary|Comission Errors at 3 Months|comission errors during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.(Test duration: 22 minutes)|3 months|||errors||Standard Deviation|Mean
850180|NCT02004236|Secondary|P3b Wave Amplitude After tRNS|ERP and behaviour Changes in ASD children after tRNS|During 3 months of intensive speech therapy during tRNS sessions|||MicroVolts||Standard Deviation|Mean
850181|NCT02004236|Secondary|Commission Errors After tRNS|ERP and behaviour Changes in ASD children after tRNS|During 3 months of intensive speech therapy during tRNS sessions|||number of errors during ECPT task||Standard Deviation|Mean
850182|NCT02004236|Secondary|Ommision Errors After tRNS|ERP and behaviour Changes in ASD children after tRNS|During 3 months of intensive speech therapy during tRNS sessions||12/2017||||
850183|NCT02004236|Secondary|Reaction Time After tRNS|ERP and behaviour Changes in ASD children after tRNS|During 3 months of intensive speech therapy during tRNS sessions|||Milliseconds||Standard Deviation|Mean
850184|NCT02004236|Secondary|P3b Wave Amplitude Before tRNS|ERP and behaviour Changes in ASD children before tRNS|During 3 months of intensive speech therapy during tRNS sessions|||MicroVolts||Standard Deviation|Mean
850185|NCT02004236|Secondary|Commission Errors Before tRNS|ERP and Behaviour changes in ASD children before tRNS|During 3 months of intensive speech therapy during tRNS sessions|||number of errors during ECPT task||Standard Deviation|Median
850186|NCT02004236|Secondary|Omission Errors Before tRNS|ERP and behaviour changes in ASD children before tRNS|During 3 months of intensive speech therapy during tRNS sessions|||number of errors during ECPT task||Standard Deviation|Mean
850187|NCT02004236|Secondary|Reaction Time in ECPT Before tRNS|ERP & Behaviour changes in ASD children after tRNS|During 3 months of intensive speech therapy during tRNS sessions|||Milliseconds||Standard Deviation|Mean
850188|NCT02004236|Secondary|Theta Amplitude in T5 After tRNS|Evaluate QEEG (brainwave changes in frequency bandfs and amplitude) after tRNS intervention in ASD children between 5 and 12 years old|During 3 months of intensive speech therapy during tRNS sessions|||MicroVolts||Standard Deviation|Mean
850189|NCT02004236|Secondary|Ratio Theta/Beta After tRNS|The purpose of the present study was to determine if the theta/beta ratio, and theta and beta separately, correlate with behavioral parameters, and if these measures discriminate between children a with Autism Spectrum disorder (ASD) and normal gender- and age-matched controls before and after tRNS intervention in ASD children between 5 and 12 years old.|During 3 months of intensive speech therapy during tRNS sessions|||Ratio theta/beta after tRNS||Standard Deviation|Mean
850190|NCT02004236|Secondary|Theta Amplitude in T5 Before tRNS|The purpose of the present study was to determine if the theta/beta ratio, and theta and beta separately, correlate with behavioral parameters, and if these measures discriminate between children a with Autism Spectrum disorder (ASD) and normal gender- and age-matched controls before and after tRNS intervention in ASD children between 5 and 12 years old.|During 3 months of intensive speech therapy during tRNS sessions|||MicroVolts||Standard Deviation|Mean
850191|NCT02004236|Secondary|Ratio Theta/Beta Before tRNS|The purpose of the present study was to determine if the theta/beta ratio, and theta and beta separately, correlate with behavioral parameters, and if these measures discriminate between children a with Autism Spectrum disorder (ASD) and normal gender- and age-matched controls before and after tRNS intervention in ASD children between 5 and 12 years old.|During 3 months of intensive speech therapy during tRNS sessions|||Ratio theta/beta before tRNS||Standard Deviation|Mean
850192|NCT02004236|Primary|Sociability|"Goal: Evaluate emphaty with CARS scale in autism spectrum disorder children between 5 and 12 years after tRNS sessions.
CARS (Childhood Autism Rating Scale) by Shopler & Reichler (1971) in Spanish version EVAI (Escala de Valoración de Autismo Infantil) by Leal-Soto, F.; Aguirre, L.P. y Williams, E.E.
Description: 15 items in the scale that evaluate: Relating to people, Imitative Behavior, Emotional Response, Body Use, Object Use, Adaptation to Change, Visual Response, Listening Response, Perceptive Response, Fear or Anxiety, Verbal Communication, Non-Verbal Communication, Activity level, Level and consistency of Intellective Relations and General Impressions.
Values: The CARS scores range from 15 to 60, with lower scores indicating better outcome. It classifies the child as not autistic (below 30), moderately autistic (30-36.5) or severely autistic (above 36.5)"|During 3 months of intensive speech therapy during tRNS sessions|Time frame: Baseline Before treatment and after completing 3 months of intensive speech therapy during tRNS sessions.||units on a scale||Standard Deviation|Mean
850256|NCT01856686|Primary|Omission Errors at 3 Months|Omission errors during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach. (Test duration: 22 minutes)|3 months|||errors||Standard Deviation|Mean
850257|NCT01856686|Primary|Reaction Time at 3 Months|Reaction time during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.|3 months|||milliseconds||Standard Deviation|Mean
850193|NCT02004236|Primary|Verbal Fluency|"Goal: Improve in verbal fluency in ASD children between 5 and 12 years. We use D-KEFS (Delis-Kaplan Executive Function System Delis Kaplan Sorting Test), Verbal Fluency Subtest - Category Condition.
Description: The verbal fluency Category test evaluates fluent productivity in the verbal domain by asking participants to generate exemplars belonging to the category animals, and subsequently, boys´ names. Participants were given 60 s to do it.
Values: Category scores were based on the average number of items generated in the two categories (animals and boys´names) during 60 s.
Time Frame: Baseline (Before treatment) and 1 day Post-treatment (after completing 3 months of intensive speech therapy during tRNS sessions)"|During 3 months of intensive speech therapy during tRNS sessions|Time frame: Baseline Before treatment and after completing 3 months of intensive speech therapy during tRNS sessions.||units on a scale||Standard Deviation|Mean
850194|NCT01995071|Secondary|Percentage of Participants With Post-treatment Relapse|Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants completing combination treatment with HCV RNA levels < LLOQ at the end of treatment.|From the end of treatment through 12 weeks after the last dose of combination study drug|Combination Treatment Analysis Set: all participants who receive at least 1 dose of the combination regimen of ABT-450/r/ABT-267 + ABT-333 + RBV, completed treatment, and had HCV RNA <LLOQ at the final treatment visit.||percentage of participants||95% Confidence Interval|Number
850195|NCT01995071|Secondary|Percentage of Participants With On-treatment Virologic Failure|On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during combination treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during combination treatment; or HCV RNA ≥ LLOQ at end of combination treatment with at least 6 weeks of combination treatment.|Up to 87 days|Combination Treatment Analysis Set: all participants who receive at least 1 dose of the combination regimen of ABT-450/r/ABT-267 + ABT-333 + RBV.||participants||95% Confidence Interval|Number
850196|NCT01995071|Secondary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of combination study drug.|12 weeks after last actual dose of combination study drug|Combination Treatment Analysis Set: all participants who receive at least 1 dose of the combination regimen of ABT-450/r/ABT-267 + ABT-333 + RBV; participants with missing data after backwards imputation were counted as nonresponders.||percentage of participants|||Number
850197|NCT01995071|Primary|Maximal Decrease From Baseline in log10 HCV RNA Levels During ABT-493 or ABT-530 Monotherapy Treatment|Maximal decrease from baseline in log10 HCV RNA levels during ABT-493 or ABT-530 monotherapy treatment. The baseline value was the last measurement before the first dose of monotherapy on Day 1.|Day 1 through prior to first dose of the combination regimen on Study Day 4|Monotherapy Analysis Sets for Substudy 1 (Arms 1-5, 11) and SubStudy 2 (Arms 6-10, 12) are defined as all participants who received at least 1 dose of monotherapy and have a baseline and at least 1 postbaseline measurement of HCV RNA during monotherapy. Data for subjects who received the same treatment (Arms 4+5; Arms 7+10) were analyzed together.||Log10 IU/mL||Standard Deviation|Mean
850206|NCT01951963|Other Pre-specified|Pain Scale Rating Agreement Among Patient, Parent, and Research Staff|"FLACC scores were assessed on the patient using the FLACC scale (0-10) by the parent, treating RN/trained research assistant.
FLACC – Parents 30 Minutes Post dose
FLACC – Staff 30 Minutes Post dose
Wong-Baker Faces scale is a self-assessment of pain Scale of 1-10 pain."|Up to 3 hours post pain medication administration|Wong-Baker Faces scale is a self-assessment of pain Scale. FLACC Score (FLACC = Face, Legs, Activity, Crying and Consolability) is a behavioral observational pain rating scale that looks for specific behaviors and scores them. Both scales are scored 0-10 with 0 representing no pain. Lower scores are better outcomes.||Scores on a scale||Standard Deviation|Mean
850207|NCT01951963|Primary|Adverse Drug Reaction|Rate of pain medication related adverse events during their ED stay and at 24 hours post discharge from the ED. the research team will complete the Adverse Event case report form to determine any adverse events occurring during the study period. Family members will be contacted via telephone 24 hours (±8 hours) following their visit in the Emergency Department to complete the Discharge Adverse Event case report form.|3 hours post study drug administration|Rate of pain medication related adverse events during their ED stay and at 24 hours post discharge from the ED will be compared using unadjusted Fisher’s exact of a composite measure (≤ 1 events vs. > 1).||Participants|||Count of Participants
850208|NCT01951963|Primary|Cumulative Narcotic Consumption|All opioids administered were converted to morphine equivalents in milligrams (eq. mg) via standard equianalgesic calculations. Pre-study drug opioids information was also collected.The number of subjects who received a morphine dose after administration of the study drug, both within one hour or at all was included in the outcome measure results.|3 hours post study drug administration|The number of subjects in each group who received at least one dose of opioids post study drug.||Participants|||Count of Participants
850537|NCT01278394|Secondary|Mycological Evaluations (Negative KOH and Negative Fungal Culture) Compared to Baseline|Number of subjects with negative KOH, and number of subjects with negative fungal cultures.|Day 270|Efficacy data were analyzed for the ITT population. For efficacy variables, the LOCF was used to impute missing observations.||participants|||Number
850238|NCT01905423|Secondary|Filarial Antigenemia in Blood and Worm Parasite Eggs in Stool by Microscopy|Secondary outcomes for the study include prevalence of filarial antigenemia (detected with the Binax Filariasis Now card test) and prevalence of worm eggs in stool detected by the Kato-Katz test. Both of these prevalence outcomes are qualitative with no units of measure (positive or negative). Prevalence date are expressed as % positive. Other secondary outcome measures will be intensity of parasite infections (microfilariae per ml of blood and the number of worm eggs per gram of stool).|4 years|Not all participants were tested for antigen or provided stool to determine prevalence of worm eggs.||Participants|||Count of Participants
850239|NCT01905423|Primary|Microfilaria Prevalence in Blood by Microscopy|Microfilariae (filarial parasites) will be detected in blood smears by microscopy. Samples will be collected in annual community surveys. Microfilaremia is a categorical variable (positive or negative). Prevalence rates are expressed as % positive.|4 years|Analysis excludes participants from Pekalongan study site that were dropped after the first follow-up due to lower than expected filariasis prevalence.||Participants|||Count of Participants
850240|NCT01856686|Secondary|Inattention Score|Inattention assessed by clinical questionnaire after 3 months of nutritional approach. Range: minimum value: 0 and maximum value: 9. Higher values represent a worse outcome.|3 months|||units on a scale||Standard Deviation|Mean
850241|NCT01856686|Secondary|Impulsivity Score|Impulsivity assessed by clinical questionnaire after 3 months of nutritional approach. Range: minimum value: 0 and maximum value: 8. Higher values represent a worse outcome.|3 months|||units on a scale||Standard Deviation|Mean
850242|NCT01856686|Secondary|Hyperactivity Score|Hyperactivity assessed by clinical questionnaire after 3 months of nutritional approach. Range: minimum value: 0 and maximum value: 8. Higher values represent a worse outcome.|3 months|||units on a scale||Standard Deviation|Mean
850243|NCT01856686|Other Pre-specified|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Number of Participants with Adverse Events as a Measure of Safety and Tolerability of Brain Proteins Supplements|Up to 8 months|||participants|||Number
850244|NCT01856686|Other Pre-specified|Body Mass Index at 3 Months|Body mass index after 3 months of dietary approach.|3 months|||kg/m2||Standard Deviation|Mean
850245|NCT01856686|Secondary|Behavior|"Behavior assessed by total score of clinical questionnaire (sum of Hyperactivity, Impulsivity and Inattention scores), after 3 months of nutritional approach.
Range: minimum value: 0 and maximum value: 25. Higher values represent a worse outcome."|3 months|||units on a scale||Standard Deviation|Mean
850246|NCT01856686|Primary|Frontal Midline Theta Activity- Amplitude at 3 Months|Frontal midline theta activity- amplitude during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.|3 months|||microvolts||Standard Deviation|Mean
850247|NCT01856686|Secondary|Monastra Ratio at 3 Months|Monastra ratio during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.|3 months|||ratio||Standard Deviation|Mean
850248|NCT01856686|Primary|Mu Waves-amplitude at 3 Months|Mu waves-amplitude during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.|3 months|||microvolts||Standard Deviation|Mean
850265|NCT01847885|Post-Hoc|30% Reduction in Pain Interference From Baseline to End of Treatment (EOT)|The degree to which shoulder pain interferes with daily activities was assessed using Question 9 of the Brief Pain Inventory (BPI-9) collected from the BPI Short Form administered during clinic visits. This question asks the subject to rate the degree to which their pain has interfered with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life on a scale of 0 to 10, where 0 is “does not interfere” and 10 is “completely interferes” within the last week. The mean of these seven scores was calculated to obtain the pain interference score. The score at End of Treatment (EOT) was compared to the baseline score to determine the percentage of subjects who had a clinically significant (30% or greater) reduction in pain interference.|4 weeks (from baseline visit to EOT visit)|Per protocol set (Subjects in the full analysis set who also were implanted with a Smartpatch Lead, had an adequate number of worst pain intensity (BPI3) scores in the End of Treatment subject diary period, and continued to meet all eligibility criteria throughout treatment)||Participants|||Count of Participants
850266|NCT01847885|Post-Hoc|Composite 30% Reduction in Pain Intensity or Pain Interference From Baseline to End of Treatment (EOT)|"Subjects who reported an reduction of at least 30% in either pain intensity or pain interference from baseline to End of Treatment (EOT) using the Brief Pain Inventory (BPI) Short Form.
The pain intensity score is excerpted from BPI question 3, worst pain, taken from 7-day diaries. This scale ranges from 0 representing no pain to 10 representing worst pain. The median diary score at EOT was compared to the median baseline diary score to calculate the percentage of subjects who had at least a 30% reduction in pain intensity.
Pain interference was assessed using BPI question 9. Subjects rated the degree to which their pain interfered with seven facets of daily life on a scale of 0 to 10, where 0 is “does not interfere” and 10 is “completely interferes”. The mean of these 7 scores was calculated to obtain the pain interference score. The score at EOT was compared to the baseline score to determine the percentage of subjects who had at least a 30% reduction in pain interference."|4 weeks (from baseline visit to EOT visit)|Per protocol set (Subjects in the full analysis set who also were implanted with a Smartpatch Lead, had an adequate number of worst pain intensity (BPI3) scores in the End of Treatment subject diary period, and continued to meet all eligibility criteria throughout treatment)||Participants|||Count of Participants
850267|NCT01847885|Other Pre-specified|Performance of the Smartpatch System|A sponsor-developed Clinician Satisfaction Survey was administered to the Investigator(s) at each site performing lead placement and included questions pertaining to use of the Smartpatch device as well as the overall impression of the therapy.|At completion of study, approximately 2.5 years|"Count of participants represents Investigators responding to the survey rather than study participants."||Participants|||Count of Participants
850268|NCT01847885|Other Pre-specified|User Satisfaction With The Smartpatch System at 12-weeks Beyond Treatment|Subjects completed the sponsor-developed Subject Satisfaction Survey at the end of the 12-week post-treatment period. The results of these surveys demonstrate the usability of the Smartpatch System and subject satisfaction with treatment.|12-week post-treatment|Safety set (Subjects who were implanted with a Smartpatch Lead)||Participants|||Count of Participants
850269|NCT01847885|Other Pre-specified|User Satisfaction With The Smartpatch System at End of Treatment|Subjects completed the sponsor-developed Subject Satisfaction Survey at the End of Treatment (EOT) visit. The results of these surveys demonstrate the usability of the Smartpatch System and subject satisfaction with treatment.|End of Treatment (4-weeks of Treatment/Control)|Safety set (Subjects who were implanted with a Smartpatch Lead)||Participants|||Count of Participants
850270|NCT01847885|Secondary|Clinical Global Impression of Improvement at End of Treatment|The Blinded Evaluator rated each subject enrolled at their site using a question adapted from the Clinical Global Impression (CGI) scale, known as the Clinical Global Impression-Improvement scale (CGI-I). For the CGI-I, a Blinded Evaluator was asked to rate the subject’s total improvement compared to their condition at baseline. The CGI-I uses a 7-point scale (centered at 4) that ranges from “very much worse” to “very much improved”.|End of Treatment (4-weeks of Treatment/Control)|Per protocol set (Subjects in the full analysis set who also were implanted with a Smartpatch Lead, had an adequate number of worst pain intensity (BPI3) scores in the End of Treatment subject diary period, and continued to meet all eligibility criteria throughout treatment). The CGI-I was not completed for one subject in the treatment group.||Participants|||Count of Participants
850271|NCT01847885|Secondary|Change in Pain Medication Usage at End of Treatment|Subjects completed 7-day diaries, in which they listed all pain medications they took during the 7 days. A blinded third party medication committee reviewed medications collected for each 7-day diary period and scored medication changes, in comparison to the baseline diary medications as “no change” (no change in dosage or change is not clinically meaningful to impact pain outcomes), “increase” (clinically meaningful increase in medication that would impact pain outcomes), or “decrease” (clinically meaningful decrease in medication that would impact pain outcomes).|End of Treatment (4-weeks of Treatment/Control)|Per protocol set (Subjects in the full analysis set who also were implanted with a Smartpatch Lead, had an adequate number of worst pain intensity (BPI3) scores in the End of Treatment subject diary period, and continued to meet all eligibility criteria throughout treatment)||Participants|||Count of Participants
850272|NCT01847885|Secondary|Patient Global Impression of Change at End of Treatment|The Patient Global Impression of Change (PGIC) scale was administered at EOT to assess subject perception of overall improvement and patient preferences. The PGIC scale asks subjects to rate their improvement with treatment on a 7-point scale (centered at 4) that ranges from “very much worse” to “very much improved” relative to baseline.|End of Treatment (4-weeks of Treatment/Control)|Per protocol set (Subjects in the full analysis set who also were implanted with a Smartpatch Lead, had an adequate number of worst pain intensity (BPI3) scores in the End of Treatment subject diary period, and continued to meet all eligibility criteria throughout treatment)||Participants|||Count of Participants
850273|NCT01847885|Secondary|Change From Baseline Average Pain Intensity at End of Treatment|"A diary was used in the study to capture daily average shoulder pain intensity over a 7-day period. The diary included a pain intensity question asked each day to the subject. The pain intensity question is excerpted from the Brief Pain Inventory - Short Form Question 5 (BPI-5) and is stated as please rate your pain by circling the one number that best describes your pain on the average. BPI-5 is a scale of 0 to 10 where 0 represents no pain and 10 represents worst pain. The mean scores were calculated for each diary period. The mean diary score at End of Treatment (EOT) was compared to the mean baseline diary score to calculate the change in pain intensity."|Baseline, End of Treatment (4-weeks of Treatment/Control)|Per protocol set (Subjects in the full analysis set who also were implanted with a Smartpatch Lead, had an adequate number of worst pain intensity (BPI3) scores in the End of Treatment subject diary period, and continued to meet all eligibility criteria throughout treatment)||scores on a scale||Standard Deviation|Mean
850274|NCT01847885|Secondary|Change From Baseline Quality of Life at End of Treatment|The Medical Outcomes Study Short Form (SF-36v2) was administered at clinic visits to assess the impact of peripheral nerve stimulation on the subject’s health-related quality of life. The SF-36v2 is a generic health survey designed to assess basic physical functioning and emotional well-being regardless of the disease or treatment. The 36 questions were grouped into two components: physical and mental. The survey was scored using norm-based scoring algorithm where a score of 0 indicates maximum disability and a score of 100 indicates no disability. Change in each component score was derived from End of Treatment score minus baseline score.|Baseline, End of Treatment (4-weeks of Treatment/Control)|Per protocol set (Subjects in the full analysis set who also were implanted with a Smartpatch Lead, had an adequate number of worst pain intensity (BPI3) scores in the End of Treatment subject diary period, and continued to meet all eligibility criteria throughout treatment)||scores on a scale||Standard Deviation|Mean
850275|NCT01847885|Secondary|Durability of Change From Baseline Shoulder Pain Intensity at 12-weeks Beyond Treatment|"A diary was used in the study to capture daily worst shoulder pain intensity over a 7-day period. The diary included a pain intensity question asked each day to the subject. The pain intensity question is excerpted from the Brief Pain Inventory - Short Form Question 3 (BPI-3) and is stated as please rate your pain by circling the one number that best describes your pain at its worst in the last 24 hours. BPI-3 is a scale of 0 to 10 where 0 represents no pain and 10 represents worst pain. The median scores were calculated for each diary period. The median diary score at 12 weeks post-treatment was compared to the median baseline diary score to calculate the change in pain intensity. The group mean of the median scores for 12 weeks post-treatment was compared to the group mean of the median scores for the control group at baseline."|Baseline, 12-wks post-treatment|Full analysis set||scores on a scale||Standard Deviation|Mean
850276|NCT01847885|Secondary|Change From Baseline Shoulder Pain Interference at End of Treatment|The degree to which shoulder pain interferes with daily activities was assessed using Question 9 of the Brief Pain Inventory (BPI-9) collected from the BPI Short Form administered during clinic visits. This question asks the subject to rate the degree to which their pain has interfered with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life on a scale of 0 to 10, where 0 is “does not interfere” and 10 is “completely interferes” within the last week. The mean of these seven scores will be calculated to obtain the pain interference score.|Baseline, End of Treatment (4-weeks of Treatment/Control)|Per protocol set (Subjects in the full analysis set who also were implanted with a Smartpatch Lead, had an adequate number of worst pain intensity (BPI3) scores in the End of Treatment subject diary period, and continued to meet all eligibility criteria throughout treatment).||scores on a scale||Standard Deviation|Mean
850277|NCT01847885|Primary|Number of Participants With Device Related Adverse Event Rates in Treatment and Control Groups|At each study visit following the baseline assessment, subjects were questioned if any changes in their medical status or condition had occurred. If the change was an adverse event, an adverse event form was completed by the site.|16 weeks total - 4 weeks from baseline visit to EOT visit, followed by 12 weeks post-treatment|Safety set||device related adverse events|||Number
850278|NCT01847885|Primary|Change From Baseline Shoulder Pain Intensity at End of Treatment (EOT)|A diary was used in the study to capture daily worst shoulder pain intensity over a 7-day period. The diary included a pain intensity question asked each day to the subject. The pain intensity question is excerpted from the Brief Pain Inventory – Short Form Question 3 (BPI-3) and is stated as “please rate your pain by circling the one number that best describes your pain at its worst in the last 24 hours”. BPI-3 is a scale of 0 to 10 where 0 represents no pain and 10 represents worst pain. The median scores were calculated for each diary period. The median diary score at End of Treatment (EOT) was compared to the median baseline diary score to calculate the change in pain intensity. The group mean of the median scores for treatment was compared to the group mean of the medians scores for the control group at baseline and at EOT.|Baseline, End of Treatment (4-weeks of Treatment/Control)|Full analysis set||scores on a scale||Standard Deviation|Mean
850285|NCT01801449|Primary|Number of Subjects Who Maintained Inflammatory Remission With Rilonacept|Inflammatory remission criteria remission criteria were defined as meeting all of the following criteria: a diary score of <0.5 (reflecting no fever, skin rash or bone pain), normal acute phase reactants (C-reactive protein (CRP) <0.5 mg/dL), no objective skin rash or radiological evidence of active bone lesions on x-ray.|6 months|Analysis included all subjects||Participants|||Count of Participants
850286|NCT01801449|Secondary|Pediatric Quality of Life Inventory (PedsQL)|Pediatric Quality of Life Inventory (PedsQL)-assess functional impairment and change in treatment and health-related quality of life respectively. Responses on this scale are transformed into a 0-100 scale, with 0 being the worst value for health-related quality of life and 100 being the best possible value for health-related quality of life.|Baseline|Analysis included all subjects||Units on a scale||Standard Deviation|Mean
850287|NCT01801449|Secondary|Pediatric Quality of Life Inventory (PedsQL)|Pediatric Quality of Life Inventory (PedsQL)-assess functional impairment and change in treatment and health-related quality of life respectively. Responses on this scale are transformed into a 0-100 scale, with 0 being the worst value for health-related quality of life and 100 being the best possible value for health-related quality of life.|24 months after rilonacept initiation|Analysis included all subjects||Units on a scale||Standard Deviation|Mean
850288|NCT01801449|Secondary|Dual-energy X-ray Absorptiometry (DEXA) Scores|Mean z-scores of anteroposterior lumbar (AP) spine were used for comparisons|Baseline|Analysis included all subjects||z-score||Standard Deviation|Mean
850289|NCT01801449|Secondary|Dual-energy X-ray Absorptiometry (DEXA) Scores|Mean z-scores of anteroposterior lumbar (AP) spine were used for comparisons|12 months after rilonacept initiation|Analysis included all subjects||z-score||Standard Deviation|Mean
850290|NCT01801449|Secondary|Childhood Health Assessment Questionnaire (CHAQ)|The Childhood Health Assessment Questionnaire (CHAQ) is a patient self-assessment (or parent assessment) tool for how illness affects ability to function in daily life. Includes overall score, overall pain rating, overall global evaluation, subcategories for dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities. Measured on scale of 0-3 from 'Without any difficulty' (0) to 'Unable to do' (3). The scores are summed and divided by the number of total categories answered to arrive at a final value.|Baseline|Analysis included all subjects||Units on a scale||Standard Deviation|Mean
850759|NCT00984165|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events, see the adverse event module.|36 months|||Participants|||Count of Participants
850291|NCT01801449|Secondary|Childhood Health Assessment Questionnaire (CHAQ)|The Childhood Health Assessment Questionnaire (CHAQ) is a patient self-assessment (or parent assessment) tool for how illness affects ability to function in daily life. Includes overall score, overall pain rating, overall global evaluation, subcategories for dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities. Measured on scale of 0-3 from 'Without any difficulty' (0) to 'Unable to do' (3). The scores are summed and divided by the number of total categories answered to arrive at a final value.|24 months after rilonacept initiation|Analysis included all subjects||Units on a scale||Standard Deviation|Mean
850292|NCT01801449|Secondary|Weight|Antropometric measurements - Weight z-score|Baseline|Analysis included all subjects||z-score||Standard Deviation|Mean
850293|NCT01801449|Secondary|Weight|Antropometric measurements - Weight z-score|24 months after rilonacept initiation|Analysis included all subjects||z-score||Standard Deviation|Mean
850294|NCT01801449|Secondary|Height|Antropometric measurements - Height z-score|Baseline|Analysis included all subjects||z-score||Standard Deviation|Mean
850295|NCT01801449|Secondary|Height|Antropometric measurements - Height z-score|24 months after rilonacept initiation|Analysis included all subjects||z-score||Standard Deviation|Mean
850341|NCT01646762|Secondary|Overall Response Rate|"Overall response rate (percentage) is defined as the percentage of patients with a partial response (PR) or better. A PR or better will be considered synonymous with success and is defined to be a stringent complete response (sCR = complete response (CR) + Normal serum FLC ratio + Absence of clonal cells in bone marrow), CR (= Negative immunofixation of the serum and urine + <5%plasma cells in bone marrow + Disappearance of any soft tissue plasmacytomas + normalization of FLC ratio), very good partial response (VGPR = PR + Serum and urine M-component detectable by immunofixation but not on electrophoresis ), or PR (≥ 50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥ 90% or to <200 mg per 24 h) noted as the objective status. The percentage of successes (PR or better) will be estimated by the number of successes divided by the total number of evaluable patients times 100. PR or better will be evaluated using all cycles of treatment."|Up to 3 years|||percentage of patients||95% Confidence Interval|Number
850342|NCT01646762|Secondary|Incidence of Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0|Toxicity is defined as a grade 3 or higher adverse events that is classified as either possibly, probably, or definitely related to study treatment. The assignment of attribution to study treatment and grade (or degree of severity) of the adverse event are classified using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. The percentage of patients with a maximum grade 3 or higher adverse event at least possibly related to the study treatment are reported below.|Up to 3 years|||percentage of patients|||Number
850343|NCT01646762|Secondary|Duration of Response of All Evaluable Patients Who Have Achieved a Partial Response or Better|Duration of response is defined for all evaluable patients who have achieved a partial response or better (stringent complete response (sCR = complete response (CR) + Normal serum FLC ratio + Absence of clonal cells in bone marrow), CR (= Negative immunofixation of the serum and urine + <5%plasma cells in bone marrow + Disappearance of any soft tissue plasmacytomas + normalization of FLC ratio), very good partial response (VGPR = partial response (PR) + Serum and urine M-component detectable by immunofixation but not on electrophoresis ), or PR (≥ 50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥ 90% or to <200 mg per 24 h) ) as the date at which the patients earliest best objective status is first noted to be at least a partial response or better to the earliest date of progression is documented. The distribution of duration of response will be estimated using the method of Kaplan-Meier.|Date at which the patient’s earliest best objective status is first noted to be at least a partial response or better to the earliest date progression is documented, assessed up to 3 years|All evaluable patients who have achieved a (unconfirmed or confirmed) partial response or better at the earliest best objective status are included in this analysis||months||Full Range|Median
850344|NCT01646762|Secondary|Progression Free Survival at 3 Months|"The distribution of time to progression will be estimated using the method of Kaplan-Meier and the 3 month progression-free rate (percentage) will be provided. Progression is defined as:
Any one or more of the following: Increase of 25% from lowest value in:
Serum M-component (absolute increase must be ≥ 0.5 g/dl
Serum M-component increase ≥ 1 g/dl, if lowest M component was ≥ 5 g/dl
Urine M-component (absolute increase must be ≥ 200 mg/24 h)
If at on study, the only measurable non-bone marrow parameter was free light chain (FLC), the difference between involved and uninvolved FLC levels (absolute increase must be >10 mg/dl)
Bone marrow plasma cell percentage (absolute % must be ≥10%) Or any one or more of the following felt related to the underlying clonal plasma cell proliferative disorder
Development of new soft tissue plasmacytomas or bone lesions
Hypercalcemia (≥11.5 mg/dl)
Decrease in hemoglobin of ≥2 g/dl
Serum creatinine level ≥2 mg/dl"|Time from registration to the earliest date of documentation of disease progression, assessed up to 3 years|||percentage of patients|||Number
850345|NCT01646762|Secondary|Survival Time|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.|Time from registration to death due to any cause, assessed up to 3 years|||months||95% Confidence Interval|Median
850346|NCT01646762|Primary|Percentage of Patients Who Have a Confirmed Partial Response or Better|"A confirmed partial response or better will be considered synonymous with success and is defined to be a stringent complete response (sCR = complete response (CR) + Normal serum FLC ratio + Absence of clonal cells in bone marrow), CR (= Negative immunofixation of the serum and urine + <5%plasma cells in bone marrow + Disappearance of any soft tissue plasmacytomas + normalization of FLC ratio), very good partial response (VGPR = partial response (PR) + Serum and urine M-component detectable by immunofixation but not on electrophoresis ), or PR (≥ 50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥ 90% or to <200 mg per 24 h) noted as the objective status on two consecutive evaluations. The percentage of successes (confirmed PR or better) will be estimated by the number of successes divided by the total number of evaluable patients times 100. Confirmed PR or better will be evaluated using all cycles of treatment."|Up to 3 years|||percentage of patients||95% Confidence Interval|Number
850451|NCT01462565|Secondary|Number of Participants With Abnormal Hematology|Values for hemoglobin, hematocrit, and platelet count were analyzed. Participants with abnormal values have been reported. The low and high value concern were as follows: hemoglobin (Males < 98, >180.0) (females <91, >161.0)grams per litre (g/L); hematocrit (Males < 32.0, >54.0) (females <29.0, >50.6) fraction (1); platelet count (< 100, > 500) gram international units per litre (gI/L).|Up to 1 week after Week 4 (Follow-up)|ITT population. Only those participant available at the indicated time points were analyzed.||Participants|||Count of Participants
850398|NCT01561976|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A serious adverse event is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect, medically significant or possible drug-induced liver injury.|Up to approximately 24 days (during treatment and washout) after initiation of study|PK Population.||Participants|||Count of Participants
850399|NCT01561976|Secondary|Terminal Phase Half Life (t1/2)|PK blood samples for estimation of t1/2 were collected at 0.0 (pre-dose) and 0.5,1,2,2.5,3,3.5,4,4.5,5,6,7,8,10, 12, 16,24 and 30 hours after dosing. Point estimates and corresponding 90% confidence interval was constructed for the ratio of the geometric mean of the test treatment (fed condition) to the geometric mean of the reference treatment (fasting condition).|0.0 (pre-dose) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 10, 12, 16, 24 and 30 hours after dosing|PK Population. Only those participants available at the indicated time points were analyzed.||Hour||Full Range|Median
850400|NCT01561976|Secondary|Elimination Constant (Kel)|PK blood samples for estimation of Kel were collected at 0.0 (pre-dose) and 0.5,1,2,2.5,3,3.5,4,4.5,5,6,7,8,10, 12, 16,24 and 30 hours after dosing. Point estimates and corresponding 90% confidence interval was constructed for the ratio of the geometric mean of the test treatment (fed condition) to the geometric mean of the reference treatment (fasting condition).|0.0 (pre-dose) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 10, 12, 16, 24 and 30 hours after dosing|PK Population. Only those participants available at the indicated time points were analyzed.||Fraction/hour||Full Range|Median
850401|NCT01561976|Secondary|PK Lag Time (Tlag)|PK blood samples for estimation of Tlag were collected at 0.0 (pre-dose) and 0.5,1,2,2.5,3,3.5,4,4.5,5,6,7,8,10, 12, 16,24 and 30 hours after dosing. Point estimates and corresponding 90% confidence interval was constructed for the ratio of the geometric mean of the test treatment (fed condition) to the geometric mean of the reference treatment (fasting condition).|0.0 (pre-dose) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 10, 12, 16, 24 and 30 hours after dosing|PK Population. Only those participants available at the indicated time points were analyzed.||Hour||Full Range|Median
850402|NCT01561976|Secondary|Time of Occurrence of Cmax (Tmax)|PK blood samples for estimation of Tmax were collected at 0.0 (pre-dose) and 0.5,1,2,2.5,3,3.5,4,4.5,5,6,7,8,10, 12, 16,24 and 30 hours after dosing. Point estimates and corresponding 90% confidence interval was constructed for the ratio of the geometric mean of the test treatment (fed condition) to the geometric mean of the reference treatment (fasting condition).|0.0 (pre-dose) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 10, 12, 16, 24 and 30 hours after dosing|PK Population. Only those participants available at the indicated time points were analyzed.||Hour||Full Range|Median
850403|NCT01561976|Secondary|AUC From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration Within a Participant Across All Treatments [AUC (0-t)]|PK blood samples for estimation of AUC (0-t) were collected at 0.0 (pre-dose) and 0.5,1,2,2.5,3,3.5,4,4.5,5,6,7,8,10, 12, 16,24 and 30 hours after dosing. Point estimates and corresponding 90% confidence interval was constructed for the ratio of the geometric mean of the test treatment (fed condition) to the geometric mean of the reference treatment (fasting condition).|0.0 (pre-dose) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 10, 12, 16, 24 and 30 hours after dosing|PK Population. Only those participants available at the indicated time points were analyzed.||µ.hr/mL||Geometric Coefficient of Variation|Geometric Mean
850404|NCT01561976|Primary|Area Under Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time [AUC (0-infinity)]|PK blood samples for estimation of AUC (0-infinity) were collected at 0.0 (pre-dose) and 0.5,1,2,2.5,3,3.5,4,4.5,5,6,7,8,10, 12, 16,24 and 30 hours after dosing. Point estimates and corresponding 90% confidence interval was constructed for the ratio of the geometric mean of the test treatment (fed condition) to the geometric mean of the reference treatment (fasting condition).|0.0 (pre-dose) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 10, 12, 16, 24 and 30 hours after dosing|PK Population. Only those participants available at the indicated time points were analyzed.||Micrograms hour per milliliter (µ.hr/mL)||Geometric Coefficient of Variation|Geometric Mean
850429|NCT01470599|Secondary|Percentage of Participants With an IBDQ Total Score of Greater Than or Equal to (≥) 170 at Week 48/ET Visit|The IBDQ is a psychometrically validated PRO instrument for measuring disease-specific QoL in participants with IBD. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). Total score is the sum of each item score, and ranged from 32 to 224 with a higher score indicating a better QoL. A score ≥170 corresponds to clinical remission. 95% Clopper-Pearson exact confidence interval reported for the proportions.|Week 48/ET|Participants in the FAS who had non-missing data at Week 48/ET visit||Percentage of participants||95% Confidence Interval|Number
850405|NCT01561976|Primary|Maximum Observed Concentration (Cmax)|Pharmacokinetic (PK) blood samples for estimation of Cmax were collected at 0.0 (pre-dose) and 0.5,1,2,2.5,3,3.5,4,4.5,5,6,7,8,10, 12, 16,24 and 30 hours after dosing. Point estimates and corresponding 90% confidence interval was constructed for the ratio of the geometric mean of the test treatment (fed condition) to the geometric mean of the reference treatment (fasting condition).|0.0 (pre-dose) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 10, 12, 16, 24 and 30 hours after dosing|PK Population included participants who received study medication. Only those participants available at the indicated time points were analyzed.||Nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
850406|NCT01535001|Other Pre-specified|Exploratory Outcomes|"Pain intensities on a 100 mm VAS with terminal descriptors of 'no pain' and 'worst pain possible' in various situations.
Number of sites with pain in the previous 24 hours shaded on a region-divided body chart
Pain location and type assessed using the Knee Pain Map.
Maximum isometric muscle strength measured bilaterally in knee flexion and knee extension in a make test using a handheld dynamometer (Powertrack II TM Commander).
Pressure pain thresholds measured bilaterally using a handheld algometer (Algometer Type II) at five sites at the knee and the m. tibialis anterior muscle and the m. extensor carpi radialis longus.
Postural balance assessed using an instrumented force platform (Good Balance), measuring the centre of pressure excursion.
Self-efficacy in improving pain, function and QOL in various situations using a 100 mm VAS with terminal descriptors of 'very unsure' and 'very sure'."|Baseline, 3months, 6months, 12months and 24months|Since this is exploratory outcomes they will be analyzed in future publications.|||||
850407|NCT01535001|Secondary|Change From Baseline in Time From the Timed Up and Go||Primary: 12 months.|||sec||95% Confidence Interval|Mean
850408|NCT01535001|Secondary|Number of Serious Adverse Events Reported at Index Knee|Adverse events (AE) and seriously adverse events (SAE) will be registered in three ways and divided into index knee or sites other than index knee. The project physiotherapist will record any adverse events that the participant experiences or tells them about. For the participants allocated to, or crossing over to, TKA, a project worker will look through hospital records to register if any pre-defined perioperative and postoperative adverse events occurred. At all follow-ups, the assessor will use open-probe questioning to assess adverse events in all participants.|Primary: 12months.|||Serious adverse events related to knee|||Number
850409|NCT01535001|Secondary|Proportion of Users of Pain Medication|With possible answers being yes and no|Baseline and 12months.|||proportion of participants||95% Confidence Interval|Number
850410|NCT01535001|Secondary|Weight Change in kg From Baseline|Weight change in kg measured without shoes at the same time of day and on the same scale|Primary: 12months.|Only patients with a BMI equal to or >25 were included in this analysis.||kg||95% Confidence Interval|Mean
850411|NCT01535001|Secondary|Change in the Five KOOS Subscale Scores From Baseline|Range of all subscales are 0 to 100 (worst to best).|Primary: 12 months.|||units on a scale||95% Confidence Interval|Number
850412|NCT01535001|Secondary|Change From Baseline in 20-meter Walk||Primary: 12months.|||sec||95% Confidence Interval|Mean
850413|NCT01535001|Secondary|Change From Baseline in EQ-5D|"Between groups comparisons of the change from baseline to the 1 year follow-up in all secondary endpoint will be handled similar to the primary endpoint. See statistical analysis plan for further description (available under Links).
Range of EQ-5D Descriptive Index is -0.59 to 1.00 (worst to best), while the EQ VAS goes from 0 to 100 (worst to best)."|Primary: 12months.|||units on a scale||95% Confidence Interval|Mean
850414|NCT01535001|Primary|Change From Baseline in KOOS4 (Knee Injury and Osteoarthritis Outcome Score)|"The average score for four of the five KOOS subscales, covering pain, symptoms, difficulties in functions of daily living, and quality of life (KOOS4), with scores ranging from 0 (worst) to 100 (best).
Between group comparisons of treatment effect (change in KOOS4 from baseline to 1 year follow-up) will be dependent on data distribution. We expect the change to be normally distributed and analysis will be made using a mixed model ANOVA with subject being a random factor and visit (baseline, 3, 6 and 12 months), treatment arm (TKA + MEDIC, MEDIC) and site (Frederikshavn, Farsoe) being fixed factors. Baseline KOOS4 will be a covariate. Furthermore interactions between the fixed factors will be included in the model. P-values and 95% CI will be presented to assess superiority."|Primary: 12months.|||units on a scale||95% Confidence Interval|Mean
850415|NCT01528592|Primary|Correlation Coefficient Between UPDRS III Score and Independent Components Analysis Network Strength in Left Parietal Cortex.|Correlation coefficient between UPDRS III score and independent components analysis network strength in left parietal cortex. UPDRS III is the Unified Parkinson's Disease Rating Scale composite motor score.|1 hour|||unitless|||Number
850416|NCT01470599|Secondary|Length of Hospitalizations Due to Crohn’s Disease|The length of hospitalizations due to Crohn's disease were recorded at every study visit.|From baseline to Week 52/follow-up|SAS||Percentage of participnats|||Number
850417|NCT01470599|Primary|Adjudicated Interstitial Lung Disease (ILD) Events|Pre-specified ILD events were adjudicated by committees of external experts who were blinded to treatment assignment. pEoI were identified by searches of the clinical, safety & laboratory databases (AEs coded to the MedDRA ILD SMQ and events nominated by the study clinician or clinical lead). The IRs determined if the pEoI met the criteria for EoI classification by assessment of the ILD event (probably ILD, possible ILD, alternative diagnosis likely, other or insufficient information to classify).|From baseline to Week 52|Participants in the SAS who had pEoI and were adjudicated by IRs|||||
850418|NCT01470599|Primary|Adjudicated Gastrointestinal (GI) Perforation Events|Pre-specified GI perforation events were adjudicated by committees of external experts who were blinded to treatment assignment. The pEoI were identified via search of AE/SAE listings using the MedDRA GI Perforation SMQ. The IRs determined if the pEoI met the criteria for EoI classification based on whether a GI perforation occurred and if yes, the location within the GI tract, possible contributing medical conditions and/or concomitant medications.|From baseline to Week 52|Participants in the SAS who had pEoI and were adjudicated by IRs||Number of events meeting criteria|||Number
850448|NCT01462565|Secondary|Breathlessness After 6MWD – Borg Dyspnoea Index (BDI)|The BDI was calculated by using a 10-point scale (0 = None, 10 = Maximum) and indicates the degree of breathlessness after completion of the 6-minute walk test. The BDI scale was assessed by each participant. Change from Baseline = score at observation minus score at Baseline. Baseline visit was Visit 2 i.e. Day-14 (+ or - 7 days).|Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) to Week 4|ITT population.||Score on a scale||Standard Deviation|Mean
850419|NCT01470599|Primary|Adjudicated Opportunistic Infection Events|Pre-specified opportunistic infection events were adjudicated by blinded committees of external experts. pEoI were identified by investigator, sponsor & search of SAE listings for serious infections coded to MedDRA infections & infestations SOC &/or events meeting pre-specified criteria for IR pre-screening to determine if adjudication is required. IRs determined if the pEoI met the criteria for EoI classification according to definitions for opportunistic infections (invasive fungal infections per the European Organization for Research & Treatment of Cancer/Invasive Fungal Infections Cooperative Group & the National Institute of Allergy & Infectious Diseases Mycoses Study Group [EORTC/MSG] Consensus Group definitions, endemic fungal infections per the EORTC/MSG Consensus Group definitions, other fungal infections, viral, bacterial & parasitic infections & vaccine dissemination) & special interest infections (actinomycosis, Legionella & mononucleosis-like toxoplasmosis).|From baseline to Week 52|Participants in the SAS who had pEoI and were adjudicated by IRs||Number of events meeting criteria|||Number
850420|NCT01470599|Primary|Adjudicated Hepatic Injury Events|Pre-specified liver injury events were adjudicated by blinded committees of external experts. pEoI were identified by investigator, sponsor & search of clinical, safety & laboratory databases (potential Hy's law event, ALT/AST ≥5 x ULN, events meeting hepatic discontinuation criteria, SAEs coded to MedDRA hepatobiliary system organ class (SOC), AEs/SAEs coded to MedDRA liver infections or infectious biliary disorders SMQ, AEs coded to MedDRA drug-induced liver injury (DILI) preferred term or any death with ALT or AST ≥3xULN, bilirubin ≥2xULN or jaundice). IRs determined if the pEoI met the criteria for EoI classification by assessing DILI (definite, highly likely, probable, possible, unlikely, unrelated or undetermined), pattern (hepatocellular, mixed, cholestatic or undetermined), likely, competing or alternative cause(s), severity (mild, moderate, severe, fatal/transplantation or undetermined), Hy’s law case, recovery & liver failure (all yes, no or undetermined).|From baseline to Week 52|Participants in the SAS who had pEoI and were adjudicated by IRs||Number of events meeting criteria|||Number
850421|NCT01470599|Secondary|Percentage of Participants Hospitalized Due to Crohn’s Disease|The number of participants hospitalized due to Crohn's disease were recorded at every study visit.|From baseline to Week 52/follow-up|SAS||Percentage of participants|||Number
850422|NCT01470599|Secondary|Change From Baseline EQ-5D VAS Scores at Week 8/ET Visit|EQ5D is a participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline and Week 48/ET visit|Participants in the FAS who had non-missing data at Week 48/ET visit||mm||Standard Deviation|Mean
850423|NCT01470599|Secondary|EQ-5D Visual Analogue Scale (VAS) Scores at Baseline and Week 8/ET Visit|EQ5D is a participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeters (mm) (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. n = number of participants with non-missing data.|Baseline and Week 48/ET visit|FAS||mm||Standard Deviation|Mean
850424|NCT01470599|Secondary|Change From Baseline EQ-5D Utility Scores at Week 48/ET Visit|"EQ5D is a participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, selfcare, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range from 0.594 to 1.000; a higher score indicates a better health state."|Baseline and Week 48/ET visit|Participants in the FAS who had non-missing data at Week 48/ET visit||Score on a scale||Standard Deviation|Mean
850425|NCT01470599|Secondary|EuroQoL 5 Dimensions Questionnaire (EQ-5D) Utility Scores at Baseline and Week 48/ET Visit|"EQ5D is a participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, selfcare, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range from 0.594 to 1.000; a higher score indicates a better health state. n = number of participants with non-missing data."|Baseline and Week 48/ET visit|FAS||Score on a scale||Standard Deviation|Mean
850426|NCT01470599|Secondary|Change From Baseline SF-36 Component and Domain Scores at Week 48/ET Visit|The component and domain scores were scored using the US 1998 general population norms. The resulting norm-based T scores for both the SF36 version 2 and SF36 health domain scales and component summary measures have means of 50 and standard deviations of 10. Higher scores indicate better health-related QoL. n = number of participants with non-missing data.|Baseline and Week 48/ET visit|FAS||Score on a scale||Standard Deviation|Mean
850427|NCT01470599|Secondary|Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 48/ET Visit|The component and domain scores were scored using the United States (US) 1998 general population norms. The resulting norm-based T scores for both the SF36 version 2 and SF36 health domain scales and component summary measures have means of 50 and standard deviations of 10. Higher scores indicate better health-related QoL. n = number of participants with non-missing data.|Baseline and Week 48/ET visit|FAS||Score on a scale||Standard Deviation|Mean
850428|NCT01470599|Secondary|Percentage of Participants With a Response to the Patient-Reported Treatment Impact (PRTI) Assessment at Week 48/ET Visit by Category|The IBD PRTI modified questionnaire comprises 3 individual questions administered to the participant: participant satisfaction with study treatment; participant preference for study drug over prior treatment (this question on participant preference for study drug is prefaced by a simple question of previous treatment/s for IBD received in order to place the preference question into context) and participant willingness to reuse the study treatment again. Each of these questions (except the question on previous treatment, which is informational only) is scored on a 5 point Likert scale. PSA = Patient Satisfaction Assessment; PPTA = Patient Previous Treatment Assessment; PPA = Patient Preference Assessment; PWA = Patient Willingness Assessment.|Week 48/ET visit|Participants in the FAS who had a response to PRTI assessment at Week 48/ET visit||Percentage of participants|||Number
850430|NCT01470599|Secondary|Change From Baseline IBDQ Total Score and Domain Scores (Bowel Function, Emotional Status, Systemic Symptoms, and Social Function) at Week 48/ET Visit|The IBDQ is a psychometrically validated PRO instrument for measuring disease-specific QoL in participants with IBD. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). The 32 items are grouped into 4 domains: bowel function, emotional status, systemic symptoms and social function. The 4 domains are scored as follows: bowel symptoms 10 to 70; systemic symptoms 5 to 35; emotional function 12 to 84; social function 5 to 35. For each domain, a higher score indicates better QoL. Total score is the sum of each item score, and ranged from 32 to 224 with a higher score indicating a better QoL. Positive change in total score indicated improvement in QoL.|Baseline and Week 48/ET|Participants in the FAS who had non-missing data at Week 48/ET visit||Score on a scale||Standard Deviation|Mean
850431|NCT01470599|Secondary|Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score and Domain Scores (Bowel Function, Emotional Status, Systemic Symptoms, and Social Function) at Baseline and Week 48/ET Visit|The IBDQ is a psychometrically validated patient reported outcome (PRO) instrument for measuring disease-specific quality of life (QoL) in participants with inflammatory bowel disease (IBD). IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). The 32 items are grouped into 4 domains: bowel function, emotional status, systemic symptoms and social function. The 4 domains are scored as follows: bowel symptoms 10 to 70; systemic symptoms 5 to 35; emotional function 12 to 84; social function 5 to 35. For each domain, a higher score indicates better QoL. Total score is the sum of each item score, and ranged from 32 to 224 with a higher score indicating a better QoL. Positive change in total score indicated improvement in QoL. n = number of participants with non-missing data.|Baseline and Week 48/early termination (ET)|FAS||Score on a scale||Standard Deviation|Mean
850432|NCT01470599|Secondary|Observed Change From Baseline in High Sensitivity C-reactive Protein (CRP) by Week|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. n = number of participants with non-missing data.|Baseline and Weeks 8, 16, 24, 36, 48 and 52/follow-up|FAS||mg per liter (mg/L)||Standard Deviation|Mean
850433|NCT01470599|Secondary|Observed Change From Baseline in Fecal Calprotectin by Week|Fecal calprotectin is an inflammatory marker for the gastrointestinal tract and considered as a measurement of neutrophil migration to the gastrointestinal tract. Higher values indicate more serious inflammation. n = number of participants with non-missing data.|Baseline and Weeks 8, 16, 24, 36, 48 and 52/follow-up|FAS||mg per kilogram (mg/kg)||Standard Deviation|Mean
850434|NCT01470599|Secondary|Percentage of Participants Switching From 5 mg BID to 10 mg BID or 10 mg BID to 5 mg BID After Initial Assignment by Visit|There was a single study treatment dose adjustment allowed, at the discretion of the Investigator, from 5 mg BID to 10 mg BID or from 10 mg BID to 5 mg BID, after the initial 8 weeks of fixed open label treatment and for the remaining treatment period of 40 weeks. Percentage of participants whose study treatment were switched from 5 mg BID to 10 mg BID or 10 mg BID to 5 mg BID after initial assignment was reported.|From baseline to Week 48|FAS||Percentage of participants|||Number
850435|NCT01470599|Secondary|Corticosteroid Use Over Time|Use of corticosteroids (yes or no) was recorded at baseline and throughout the study. Percentage of participants taking corticosteriod at each visit was reported.|Weeks 8, 16, 24, 36 and 48|SAS||Percentage of participants|||Number
850436|NCT01470599|Secondary|Percentage of Participants Achieving a Steroid-Free Clinical Remission at Week 48 - Among Subjects on Steroids at A3921086 Baseline|Steroid-free clinical remission at Week 48 was a CDAI <150 points in participants who were steroid-free at Week 48. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, intensity of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.|Week 48|Participants in FAS who were on steroids at baseline of this study||Percentage of participants||95% Confidence Interval|Number
850437|NCT01470599|Secondary|Change From Baseline Observed CDAI Score by Week|CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, intensity of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity. n = number of participants with non-missing data.|Weeks 8, 16, 24, 36, 48 and 52/follow-up|FAS||Score on a scale||Standard Deviation|Mean
850438|NCT01470599|Secondary|Observed CDAI Score by Week|CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, intensity of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity. n = number of participants remaining at risk.|Baseline and Weeks 8, 16, 24, 36, 48 and 52/follow-up|FAS||Score on a scale||Standard Deviation|Mean
850439|NCT01470599|Secondary|Time to Relapse Among Participants in Clinical Remission at Baseline|"Relapse was defined as an increase in CDAI of more than (>) 100 points from the baseline and an absolute CDAI score of >220 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, intensity of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity. Data presented are rates estimated from Kaplan-Meier curves.
n = number of participants remaining at risk."|From baseline to Week 52|Participants in the FAS who met clinical remission criteria at baseline of this study||Percentage of participants||95% Confidence Interval|Number
850449|NCT01462565|Secondary|Change From Baseline in Six Minute Walk Distance Test (6MWD) After 4-weeks of Treatment|This assessment was a non-encouraged test that measures the distance walked for a duration of 6 minutes. Change from Baseline was calculated as value at observation minus value at Baseline. Baseline visit was Visit 2 i.e. Day-14 (+ or - 7 days).|Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) and Week 4|ITT population.||meters||Standard Deviation|Mean
850440|NCT01470599|Secondary|Percentage of Participants in Clinical Remission and Sustained Clinical Remission Among Participants in Clinical Response (CDAI-100 Response) or Clinical Remission at Baseline of This Study|CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, intensity of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity. Clinical remission was defined as a CDAI score of <150. Sustained clinical remission was defined as being in clinical remission (CDAI score <150) at both Week 24 and Week 48. Clinical response was defined as a CDAI score reduction of at least 100 points from the A3921083 study baseline value. 95% Clopper-Pearson exact confidence interval reported for the proportions. n = number of participants with non-missing data.|Baseline and Weeks 8, 16, 24, 36, 48 and 52/follow-up|Participants in the FAS who met clinical response or clinical remission criteria at baseline of this study||Percentage of participants||95% Confidence Interval|Number
850441|NCT01470599|Secondary|Percentage of Participants in Clinical Remission and Sustained Clinical Remission Among Participants in Clinical Remission at Baseline of This Study|CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, intensity of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity. Clinical remission was defined as a CDAI score of <150. Sustained clinical remission was defined as being in clinical remission (CDAI score <150) at both Week 24 and Week 48. 95% Clopper-Pearson exact confidence interval reported for the proportions. n = number of participants with non-missing data.|Baseline and Weeks 8, 16, 24, 36, 48 and 52/follow-up|Participants in the FAS who met clinical remission criteria at baseline of this study||Percentage of participants||95% Confidence Interval|Number
850442|NCT01470599|Secondary|Percentage of Participants in Clinical Remission and Sustained Clinical Remission at Week 48|CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, intensity of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity. Clinical remission was defined as a CDAI score of less than (<) 150. Sustained clinical remission was defined as being in clinical remission (CDAI score <150) at both Week 24 and Week 48. 95 percent (%) Clopper-Pearson exact confidence interval reported for the proportions. n = number of participants with non-missing data.|Week 48|Full analysis set (FAS) - consisted of all participants enrolled in this OL extension study.||Percent||95% Confidence Interval|Number
850443|NCT01470599|Primary|Adjudicated Malignancy Events|Pre-specified malignancy events were adjudicated by committees of external experts who were blinded to treatment assignment. pEoI were identified by the investigator, sponsor, potential primary event notifications (i.e. malignancies excluding non-melanoma skin cancers) for a specific protocol, events submitted for histopathology review for potential malignancies which met the criteria for potential malignancies, and by search of AE/SAE listings for events coded to Malignant tumors Standard Medical Dictionary for Regulatory Activities (MedDRA) Queries (SMQ) (20000194). IRs determined if the pEoI met the criteria for EoI classification according to the International Classification of Diseases for Oncology, a ten-digit multi-axial classification of the site (4 characters), morphology (4 digits), behavior (1 digit), and grading (1 digit) of neoplasms.|From baseline to Week 52|Participants in the SAS who had pEoI and were adjudicated by IRs||Number of events meeting criteria|||Number
850444|NCT01470599|Primary|Adjudicated Potential Cardiovascular Events|Pre-specified cardiovascular events were adjudicated by committees of external experts who were blinded to treatment assignment. Potential events of interest (pEoI) were identified by the investigator, sponsor, review of alerts from central electrocardiogram assessments, and by search of adverse events (AE)/serious adverse event (SAE) listings for events coded to death (coronary and non-coronary), myocardial infarction (non-fatal), all coronary revascularization, unstable angina, stroke (fatal and non-fatal), transient ischemic attack, congestive heart failure, peripheral arterial vascular disease, dyspnoea, and chest pain. The independent reviewers (IRs) determined if the pEoI met the criteria for EoI classification according to the definitions summarized from the Clinical Data Interchange Standards Consortium ‘Standardized Definitions for End Point Events in Cardiovascular Trials’ published October 2010.|From baseline to Week 52|Participants in the SAS who had pEoI and were adjudicated by IRs||Number of events meeting criteria|||Number
850445|NCT01462565|Secondary|Number of Participants With Urine Pregnancy Test Positive|Urine samples were collected for urine pregnancy test. Urine samples were collected at up to the treatment follow up (1 week after Visit 3 [Week 4]). Number of participants with urine pregnancy test positive has been reported.|up to the treatment follow up (1 week after Visit 3 [Week 4])|ITT population. Only those participants with data available at the indicated time point were analyzed.||Participants|||Count of Participants
850446|NCT01462565|Secondary|Mean Oxygen Saturation in Blood Over Time|Pulse oximetry (oxygen saturation) was analyzed. Data for Pulse oximetry (oxygen saturation) was analyzed up to the treatment follow up (1 week after Visit 3 [Week 4]).|up to the treatment follow up (1 week after Visit 3 [Week 4])|ITT population. Only those participant available at the indicated time points were analyzed.||Percentage of oxygen in blood||Standard Deviation|Mean
850447|NCT01462565|Secondary|World Health Organization [WHO] Functional Class at Baseline and After 4- Weeks of Treatment|World Health Organization functional class was analyzed as class I, class II, class III and class IV. World Health Organization functional class was analyzed at Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) and Week 4. The classed were defined as Class I: No symptoms of pulmonary arterial hypertension with exercise or at rest, Class II: No symptoms at rest but uncomfortable and short of breath with normal activity, Class III: May not have symptoms at rest but activities greatly limited by shortness of breath, fatigue, or near fainting and Class IV: Symptoms at rest and severe symptoms with any activity. Hence the severity increased from class I (better) to Class IV (worse).|Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) and Week 4|ITT population. Only those participants with data available at the specified time point were analyzed.||Participants|||Count of Participants
850450|NCT01462565|Secondary|Number of Participants With Abnormal Urinalysis|Dipstick method was used to measure blood, glucose and protein. Data was analyzed up to 1 week after Week 4 (Follow-up visit).|Up to 1 week after Week 4 (Follow-up)|ITT population.||Participants|||Count of Participants
850452|NCT01462565|Secondary|Number of Participants With Abnormal Clinical Chemistry|Abnormal clinical chemistry was analyzed as follows: serum alanine aminotransferase (ALT/SGPT) >= 3 x upper limit of normal (ULN) , aspartate aminotransferase (AST/SGOT) >= 3 x ULN , total bilirubin >= 34.2, creatinine >= 176.8.|Up to 1 week after Week 4 (Follow-up)|ITT population.||Participants|||Count of Participants
850453|NCT01462565|Secondary|Change From Baseline in Vital Signs at Week 4: Heart Rate|Summary mean change in heart rate measured in beats per minute (beats/min or BPM). Change from Baseline was calculated as the value at the indicated time points minus the value at Baseline. Baseline was Visit 2 i.e. Day-14 (+ or - 7 days).|Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) to Week 4|ITT population.||beats/min||Standard Deviation|Mean
850454|NCT01462565|Secondary|Change From Baseline in Vital Signs at Week 4 : Systolic and Diastolic Blood Pressure|Systolic blood pressure is a measure of blood pressure while the heart is beating. Diastolic blood pressure is a measure of blood pressure while the heart is relaxed. Change from Baseline was calculated as the value at the indicated time points minus the value at Baseline. Baseline was Visit 2 i.e. Day-14 (+ or - 7 days).|Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) and Week 4(Visit 3)|ITT population.||Millimeter of mercury (mmHg)||Standard Deviation|Mean
850455|NCT01462565|Secondary|Number of Participants With Infusion Site Reactions During Treatment Period|Infusion site reactions were reported during the treatment period. Infusion site was inspected for erythema, excoriation, induration, skin necrosis or signs of local sepsis.|Baseline visit (Visit 2) to Week 4 (Visit 3)|ITT population.||Participants|||Count of Participants
850456|NCT01462565|Secondary|Number of Participants With Any Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events(SAEs)|An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. An SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, congenital anomaly/birth defect and medically significant and all events of possible drug-induced liver injury with hyperbilirubinaemia. Only treatment emergent AEs and SAEs were reported in this outcome measure. Specifically, this study reported 2 SAEs, but only 1 was categorized as treatment emergent.|Up to visit 3 (Week 4)|ITT population.||Participants|||Count of Participants
850457|NCT01462565|Primary|Change From Baseline in Dose of Thermo Stable Epoprostenol Sodium at Week 4|Dose titration requirement was assessed at the time of discharge. Change from Baseline was calculated as score at observation minus score at Baseline. Units- nanogram per kilogram per minute (ng/kg/min). Baseline was Visit 2 i.e . Day-14 (+ or - 7 days).|Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) and Week 4|ITT population.||ng/kg/min||Standard Deviation|Mean
850458|NCT01462565|Primary|Change From Baseline in Study Specific Participant Acceptance Survey|Study-specific questionnaire comprised the pre-defined15 questions which included activities of daily living assessment. Participants rated the question on a scale of 1 to 10, where 1 was do not agree and 10 was strongly agree. Change from Baseline was calculated as score at observation minus score at Baseline. Changes from Baseline was assessed for Questions 2 to 12. Baseline was defined as Visit 2 i.e. Day-14 (+ or - 7 days).|Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) and Week 4 (Visit 3).|ITT population.||Score on a scale||Standard Deviation|Mean
850459|NCT01462565|Primary|Change From Baseline in Medical Outcomes Study Short Form 36 (SF-36)|Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health), 2 summary scores (physical component and mental component), and a self-evaluated change in health status. Subscale and summary scores range: 0-100. Higher subscale and summary scores was considered as better health status. Change from Baseline was calculated as score at observation minus score at baseline. Baseline was defined as Visit 2 i.e. Day-14 (+ or - 7 days).|Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) and Week 4 (Visit 3)|Intent-to-Treat (ITT) population consisted of all participants who received at least one dose of epoprostenol sodium during the Run-in period (either currently marketed epoprostenol sodium or the study drug).||Score on a scale||Standard Deviation|Mean
850460|NCT01462292|Secondary|Assessment of Functional Outcome by : Physician Assessment of Daily Living|This was conducted by the physician, which helped to assess and document observed changes in the participant by the physician reported by the participant or his family or caregiver. This was reported as any worsening and any improvement up to week 24.|Week 24 and Week 48|ITT population. Only those participants available at the specified time points were analyzed.||Participants|||Count of Participants
850461|NCT01462292|Secondary|Assessment of Functional Outcome by : Functional Outcomes Survey During Treatment Period|This was conducted by the family or caregiver. This helped to document the observed changes in the participant’s functional outcome like the day to day activities; general health, mobility, and other general daily activities. The data for Week 24 has been reported as improved, not improved and not applicable.|Up to Week 24|ITT population. Only those participants available at that particular time points were analyzed.||Participants|||Count of Participants
850462|NCT01462292|Secondary|Number of Clinician Global Impression of Improvement (CGI-I) Responders|Single item question designed to provide a brief, stand-alone assessment of the clinician’s view of the participant’s global functioning after initiating a study medication, compared to their global functioning just prior to initiating treatment. Evaluated by an expert physician or evaluator familiar with DMD and who could make an expert clinical global judgement about severity of illness across various time points within context of clinical experience. The CGI-I reflects the clinician’s judgment about the total picture of the participant : the illness severity, the level of distress and other aspects of impairment, and impact of illness on functioning. The CGI-I is rated without regard to clinician’s belief that any clinical changes are or are not due to medication and without consideration of etiology of symptoms. It is measured on 7-point Likert scale (1 = ‘very much improved’, 2 = ‘much improved’, 4 = ‘no change’, 5 = ‘minimally worse’, 6 = ‘much worse’, 7 = ‘very much worse’).|Week 24 and Week 48|ITT population. Only those participants available at the specified time points were analyzed.||Participants|||Count of Participants
850463|NCT01462292|Secondary|Number of Participants With Change From Baseline in Dystrophin Expression at Week 24 by Immunofluorescence Assay (IFA)|A muscle biopsy from the tibialis anterior muscle was taken to assess the expression of dystrophin. The muscle biopsy samples were collected by open biopsy or with the conchotome method according to standard hospital procedures for obtaining muscle biopsies from children. The minimum amount of muscle tissue required is a small piece of muscle of at least 0.5 x 0.5 x 0.5 centimeters. The muscle tissue was immediately frozen in liquid nitrogen-cooled 2-methylbutane and stored at -80°Celsius (C) or -70°C till shipment. In case of DMD participants , there is defect in the dystrophin producing gene or absence. Data for number of participants with change from baseline in dystrophin expression, was diagnosed using IFA and was categorized as strong increase, increase, and no change, decrease.|Baseline (Week 0) and Week 24|ITT population. Only those participants available at the specified timepoints were analyzed.||Participants|||Count of Participants
850464|NCT01462292|Secondary|Change From Baseline in Sniff Pressure Test at Week 24|This was one of the pulmonary function test which was a non-invasive procedure. It measured the inspiratory muscle strength by transdiaphragmatic (Pdi) and esophageal pressures (Pes) generated during volitional and nonvolitional maneuvers. Change from Baseline, was defined as the post-randomization value minus the baseline value. Baseline was defined as Week 0.|Baseline (Week 0) and Week 24|ITT Population. Only those participants available at the specified time points were analyzed||Centimeter of water||Standard Deviation|Mean
850465|NCT01462292|Secondary|Change From Baseline in Peak Expiratory Flow at Week 24|The peak expiratory flow is a measure of the amount of air that can be pushed through the airways in a single rapid exhalation. The peak expiratory flow was measured using spirometry. Change from Baseline, was defined as the post-randomization value minus the baseline value. Baseline was defined as Week 0.|Baseline (Week 0) and Week 24|ITT population. Only those participants available at the specified time points were analyzed||Litres per minute||Standard Deviation|Mean
850466|NCT01462292|Secondary|Change From Baseline in Peak Cough Flow at Week 24|The peak cough flow was conducted using a spirometer. Change from Baseline, was defined as the post-randomization value minus the Baseline value. Baseline was defined as Week 0.|Baseline (Week 0) and Week 24|ITT population. Only those participants available at the indicated timepoints were used for analysis||Litres per minute||Standard Deviation|Mean
850467|NCT01462292|Secondary|Change From Baseline in Forced Vital Capacity (FVC) at Week 24|FVC is defined as the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Change from Baseline, was defined as the post-randomization value minus the baseline value. Baseline was defined as Week 0.|Baseline (Week 0) and Week 24|ITT population. Only those participants available at the indicated timepoints were used for analysis.||Litres||Standard Deviation|Mean
850468|NCT01462292|Secondary|Change From Baseline in Forced Expiratory Volume in the First Second of Exhalation (FEV1) at Week 24|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change from Baseline, was defined as the post-randomization value minus the Baseline value. Baseline was defined as Week 0.|Baseline (Week 0) and Week 24|ITT Population. Only those participants available at the indicated timepoints were used for analysis||Litres||Standard Deviation|Mean
850469|NCT01462292|Secondary|Change From Baseline in Creatinine Kinase Serum Concentrations|Creatine kinase (CK) is a muscle-specific enzyme; its level in plasma is considered to reflect the extent of muscle damage. In the blood samples drawn to this purpose, the plasma level of CK was measured. Change from Baseline, was defined as the post-randomization value minus the baseline value. Baseline was defined as Week 0.|Baseline (Week 0) and Week 48|ITT population. Only those participants available at the specified time points were analyzed.||International units per liter||Standard Error|Least Squares Mean
850470|NCT01462292|Secondary|Number of Participants With Accidental Falls During 6 Minute Walk Distance Test|The participants during the 6 minute walk distance were asked to walk, at their own preferred speed, up and down a fixed distance until they were told to stop after 6 minutes. The participants were warned of the time and were told to stop earlier if they feel unable to continue. The total distance walked within the duration of 6 minutes (or until the participant stopped in case of early termination of the test), was recorded in metersThe number of accident falls during the 6 minute walk distance were reported. Data is reported for the number of participants with accidental falls of 0, 1 and 2.|Baseline (Week 0), Week 24, Week 36 and Week 48|ITT Population. Only those participants available at the specified timepoints were analyzed||Participants|||Number
850471|NCT01462292|Secondary|Change From Baseline in the North Star Ambulatory Assessment (NSAA) Total Score|The NSAA was a functional scale devised from Hammersmith Scale of Motor Ability specifically for use in ambulant children with DMD. It consists of 17 activities graded 0 (unable to perform), 1 (performs with modifications), 2 (normal movement). The scale assessed activities that required for ambulatory activity and included items that were rarely achieved in untreated DMD (jump, hop, raise head) as well as items that are known to progressively deteriorate over time (stand from a chair, walk). A standardized manual is available within the SPM with specific instructions for grading. Video snaps used in training program to ensure evaluator reliability. The total score ranged from 0-34 where the highest score of 34 implies absence of symptoms and lower score implies more severe symptoms. Change from Baseline, was defined as the post-randomization value minus the baseline value. Baseline was defined as Week 0.|Baselie (Week 0) and Week 24|ITT Population||Scores on scale||Standard Error|Least Squares Mean
850472|NCT01462292|Secondary|Change From Baseline in Muscle Strength Tests For-Knee Extensor, Knee Flexor, Hip Flexor, Elbow Flexor, Elbow Extensor, Shoulder Abductor at Week 24|The muscle strength was recorded by handheld myometry using a microFET2 myometer. Upper and lower limb proximal muscles were evaluated including knee flexors, knee extensors, elbow flexors, elbow extensors, shoulder abductors and hip flexors. Change from Baseline, was defined as the post-randomization value minus the Baseline value. Baseline was defined as Week 0.|Baseline (Week 0) and Week 24|ITT population.||lbs||Standard Deviation|Mean
850502|NCT01314118|Secondary|Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in Prostate-Specific Antigen (PSA) Levels After 3 Cycles of Treatment|Percentage of participants with greater than or equal to 50 percent decrease in PSA levels was assessed. Decrease in PSA levels represented improvement.|End of Cycle 3 (Approximately Month 3)|Efficacy evaluable set included all participants who received at least 1 dose of study drug, completed at least 1 cycle of treatment and had at least 1 post-baseline PSA assessment.||Percentage of Participants||95% Confidence Interval|Number
850473|NCT01462292|Secondary|Change From Baseline in Muscle Strength Total Score at Week 24|The muscle strength was recorded by handheld myometry using a microFET2 myometer. Upper and lower limb proximal muscles were evaluated including knee flexors, knee extensors, elbow flexors, elbow extensors, shoulder abductors and hip flexors. Total score was calculated by summing up all individual scores. If data for any of the individual muscle strength tests was missing, the total score were set to missing for that visit. Change from Baseline, was defined as the post-randomization value minus the Baseline value. Baseline was defined as Week 0.|Baseline (Week 0) and Week 24|ITT Population. Only those participants available at the specified timepoints were analyzed||Pounds (lbs)||Standard Error|Least Squares Mean
850474|NCT01462292|Secondary|Change From Baseline in 10 Meter Walk/Run at Week 24|The participants during this assessment were asked to traverse marked 10-meter measured walkway as quickly as he safely can. Time was recorded to one tenth of a second with a stop watch from when his first foot crossed the start line until when the second foot crossed the finish line. How often the participant , touched the wall was to be noted. Care was taken to ensure that the participants were safe when completing this test. The assessor was allowed to walk nearby to provide ‘emergency’ help if needed, but must not support or provide manual assistance for the participant in any way. If the participant was unable to complete the 10-meter walk, the total distance was recorded. The participants were to perform the test in bare feet. No aids or orthoses were allowed. Change from Baseline, was defined as the post-randomization value minus the Baseline value. Baseline was defined as Week 0.|Baseline (Week 0) and Week 24|ITT population.||Seconds||Standard Error|Least Squares Mean
850475|NCT01462292|Secondary|Change From Baseline in 4 Stair Climb Ascent/Descent Time at Week 24|During this assessment, the participants were asked to ascend and descend four steps. The time for this was recorded with a stopwatch from the initiation of movement until the participant stands on the fourth step, (going up and going down separately). A flight of steps with handrail were used for this test. Change from Baseline, was defined as the post-randomization value minus the Baseline value. Baseline was defined as Week 0.|Baseline (Week 0) and Week 24|ITT Population||seconds||Standard Error|Least Squares Mean
850476|NCT01462292|Secondary|Change From Baseline in Rise From Floor Time at Week 24|The rise from floor was assessed, when the participants stood from a standardized supine position as quickly as possible when told to go. Time was recorded with a stopwatch from the initiation of movement until the assumption of upright standing. No aids or orthoses were allowed. Change from Baseline, was defined as the post-randomization value minus the Baseline value. Baseline was defined as Week 0.|Baseline (Week 0) and Week 24|ITT Population||Seconds||Standard Error|Least Squares Mean
850477|NCT01462292|Primary|Mean Change From Baseline in Muscle Function Using the 6 Minute Walking Distance|The participants during this assessment were asked to walk, at their own preferred speed, up and down a fixed distance until they were told to stop after 6 minutes. The participants were warned of the time and were told to stop earlier if they feel unable to continue. The total distance walked within the duration of 6 minutes (or until the participant stopped in case of early termination of the test), was recorded in meters. Change from Baseline, was defined as the post-randomization value minus the Baseline value. Baseline was defined as Week 0.|Baseline (Week 0) and Week 24|Intent to Treat (ITT) Population was defined as all participants who were randomized to the study, received at least one dose of study medication and have at least one post-Baseline efficacy assessment||Meters||Standard Error|Least Squares Mean
850478|NCT01435174|Primary|Pharmacokinetic Parameters of Ranolazine|Peak Plasma Concentration (Cmax) with a 500 mg dose of ranolazine|At hours post-dose: 0, 2, 4, 8, 12, 15, 18, 20, 22, 23, 26, 30, 65|||mcg/mL||Standard Deviation|Mean
850479|NCT01410409|Other Pre-specified|Exploratory Outcomes|"Pain intensities on a 100 mm VAS with terminal descriptors of 'no pain' and 'worst pain possible' in various situations.
Number of sites with pain in the previous 24 hours shaded on a region-divided body chart
Pain location and type assessed using the Knee Pain Map.
Maximum isometric muscle strength (converted to Nm using the length of the lower leg) measured bilaterally in knee flexion and knee extension in a make test using a handheld dynamometer (Powertrack II TM Commander from JTech Medical Industries, Salt Lake City, Utah, USA)
Pressure pain thresholds measured bilaterally using a handheld algometer (Algometer Type II, Somedic AB, Hoerby, Sweden)) at five sites at the knee and the m. tibialis anterior muscle.
Self-efficacy in improving pain, function and QOL in various situations using a 100 mm VAS with terminal descriptors of 'very unsure' and 'very sure'.
Further exploratory objectives may be added later on."|Baseline, 3months, 6months, 12months and 24 months.|Will be reported in later publications, as it is exploratory outcomes|||||
850480|NCT01410409|Secondary|Serious Adverse Events Related to the Index Knee|Adverse events (AE) and seriously adverse events (SAE) will be registered in three ways and divided into index knee or sites other than index knee. The project physiotherapist will record any adverse events that the participant experiences or tells them about. For the participants allocated to, or crossing over to, TKA, a project worker will look through hospital records to register if any pre-defined perioperative and postoperative adverse events occurred. At all follow-ups, the assessor will use open-probe questioning to assess adverse events in all participants|Primary: 12months|||Serious adverse events related to knee|||Number
850481|NCT01410409|Secondary|Proportion of Users of Pain Medication|With possible answers being yes and no|Baseline and 12months.|||proportion of participants||95% Confidence Interval|Number
850482|NCT01410409|Secondary|Weight Change in kg From Baseline|Weight change in kg measured without shoes at the same time of day and on the same scale|Primary: 12months.|Only patients with a BMI equal to or >25 were included in the analysis||kg||95% Confidence Interval|Mean
850483|NCT01410409|Secondary|Change in the Five Subscales of KOOS From Baseline|All subscales going from 0 to 100 (worst to best)|Primary: 12months.|||units on a scale||95% Confidence Interval|Mean
850484|NCT01410409|Secondary|Change in 20-meter Walk From Baseline||Primary: 12months.|||sec||95% Confidence Interval|Mean
850485|NCT01410409|Secondary|Change in Timed Up & Go (TUG) From Baseline||Primary: 12months.|||sec||95% Confidence Interval|Mean
850486|NCT01410409|Secondary|Change in EQ-5D From Baseline|"Between groups comparisons of the change from baseline to the 1 year follow-up in all secondary endpoint will be handled similar to the primary endpoint. See Statistical analysis plan for further description (Links)
Range of EQ-5D Descriptive Index is -0.59 to 1.00 (worst to best), while the EQ VAS goes from 0 to 100 (worst to best)."|Primary: 12months.|||units on a scale||95% Confidence Interval|Mean
850487|NCT01410409|Primary|Change in KOOS4 From Baseline (Knee Injury and Osteoarthritis Outcome Score)|The average score for four of the five KOOS subscales, covering pain, symptoms, difficulties in functions of daily living, and quality of life (KOOS4), with scores ranging from 0 (worst) to 100 (best). Between group comparisons of treatment effect (change in KOOS4 from baseline to 1 year follow-up) will be dependent on data distribution. Between group comparisons of treatment effect (change in KOOS4 from baseline to 1 year follow-up) will be dependent on data distribution. We expect the change to be normally distributed and analysis will be made using a mixed model ANOVA with subject being a random factor and visit (baseline, 3, 6 and 12 months), treatment arm (TKA + MEDIC, MEDIC) and site (Frederikshavn, Farsoe) being fixed factors. Baseline KOOS4 will be a covariate. Furthermore interactions between the fixed factors will be included in the model. P-values and 95% CI will be presented to assess superiority.|Primary: 12months.|||units on a scale||95% Confidence Interval|Mean
850536|NCT01278394|Secondary|Mycological Evaluations (Negative KOH and Negative Fungal Culture) Compared to Baseline|Number of subjects with negative KOH, and number of subjects with negative fungal cultures.|Day 360|Efficacy data were analyzed for the ITT population. For efficacy variables, the LOCF was used to impute missing observations.||participants|||Number
850503|NCT01314118|Secondary|Time to Prostate-Specific Antigen (PSA) Progression|Time to PSA progression is defined as the time interval from the date of enrollment (Day 1) to the date of first evidence of PSA progression. A participant was considered to have a PSA progression if the PSA level had a 25 percent (%) or greater increase and an absolute increase of 2 nanogram (ng)/milliliter (mL) or more, which is confirmed by a second value obtained in 3 or more weeks.|Maximum up to Month 30.5|All enrolled set included all participants who received at least 1 dose of study drug.||Months||95% Confidence Interval|Median
850504|NCT01314118|Secondary|Time to Radiographic Evidence of Disease Progression (TTRP)|Time to radiographic evidence of disease progression is defined as the time interval from the date of enrollment (Day 1) to the date of disease progression. A participant was considered as progressed by bone scan if: 1) The appearance of greater than or equal to (>=) 2 new lesions, and, following the first assessment, a confirmatory scan performed 6 or more weeks later that shows a minimum of 2 or more additional new lesions, 2) If >=2 new lesions are seen on scans following the first assessment, the confirmation is still required after 6 weeks; however, 2 addition lesions are not required to confirm progression, and 3) The date of progression is the date of the first scan that shows the changes.|Maximum up to Month 30.5|All enrolled set included all participants who received at least 1 dose of study drug.||Months||95% Confidence Interval|Median
850505|NCT01314118|Primary|Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in Prostate-Specific Antigen (PSA) During the Core Study|Percentage of participants with greater than or equal to 50 percent decrease in PSA levels was assessed.|End of core study visit (Approximately at Month 6)|Efficacy evaluable set included all participants who received at least one dose of study drug, completed at least 1 cycle of treatment and had at least 1 post-baseline PSA assessment.||Percentage of participants||95% Confidence Interval|Number
850506|NCT01311024|Secondary|Outpatient Antibiotic Treatment|Register follow-up up to 8 years after the vaccination of the younger sibling in the family|Up to 8 years||||||
850507|NCT01311024|Secondary|Tympanostomy Tube Surgery|Register follow-up up to 8 years after the vaccination of the younger sibling in the family|Up to 8 years||||||
850508|NCT01311024|Secondary|Hospital-diagnosed Pneumonia|Register follow-up up to 8 years after the vaccination of the younger sibling in the family|Up to 8 years||||||
850509|NCT01311024|Secondary|Invasive Pneumococcal Disease|Register follow-up up to 8 years after the vaccination of the younger sibling in the family|Up to 8 years||||||
850510|NCT01311024|Secondary|Carriage Due to Haemophilus Influenzae|Nasopharyngeal and oropharyngeal swabs taken once at 3 to 7 years of age when the vaccinated sibling is at least 12 months of age|one sampling at 3 to 7 years of age||||||
850511|NCT01311024|Secondary|Carriage Due to Any Pneumococcal Serotype|Nasopharyngeal and oropharyngeal swabs taken once at 3 to 7 years of age when the vaccinated sibling is at least 12 months of age|one sampling at 3 to 7 years of age||||||
850512|NCT01311024|Primary|Carriage Due to Any Pneumococcal Serotype Included in the Ten-valent Pneumococcal Conjugate Vaccine (PCV10) Vaccine in Older Siblings of Children Vaccinated With Infant Schedules|Carriage due to any pneumococcal serotype included in the ten-valent pneumococcal conjugate vaccine (PCV10) vaccine in older siblings of children vaccinated with infant schedules. Nasopharyngeal swabs taken once at 3 to 7 years of age when the vaccinated sibling is at least 12 months of age|one sampling at 3 to 7 years of age|||percentage of subjects|||Number
852907|NCT01596283|Secondary|Postoperative Length of Stay|Assess the impact of GDT compared to standard fluid therapy on net fluid balance for the total admission time|Postoperatively for the total admission time, up to 8 days|||days||Full Range|Median
852908|NCT01596283|Secondary|Total Volume of Fluid Used Postoperatively|Postoperative fluid volume|Postoperatively for the total admission time, up to 8 days|||liter||Standard Deviation|Mean
852909|NCT01596283|Secondary|Total Volume of Fluid Used Perioperatively|Assess the impact of GDT compared to standard fluid therapy on the total volume of fluid given intraoperatively|Up to the first 72 hours postoperatively|||liter||Standard Deviation|Mean
852910|NCT01596283|Secondary|Low Cardiac Output Time|Assess the impact of GDT compared to standard fluid therapy on the total time patients experience low cardiac output perioperatively|Up to the first 24 postoperative hours|||minutes||Standard Deviation|Mean
852911|NCT01596283|Primary|Postoperative Complications|The incidence of overall 30-day postoperative complications will be recorded. These are defined in the MSKCC Adverse Events Program and organized by categories reflecting organ systems and further subdivided into specific complications within those and graded.|30 days post procedure|||Participants|||Count of Participants
852912|NCT01594385|Other Pre-specified|Would Complication|Tracking of wound infection, dehiscence, hernia, or any other would-related complication of complaint|Up to 1 year follow-up period|||Wound complication|||Number
852913|NCT01594385|Other Pre-specified|Patient Functional Outcomes|"Assessment of Glasgow Outcome Scale (GOS) and the Functional Outcome Measures (FOM) during the available follow-up period.
FOM Source: [1] Ohio Dept of Public Safety. Ohio Trauma Registry Data Dictionary. Columbus: 2004.
FOM Scale range: 1 (worst) to 4 (best); GOS Scale: 1 (worst) to 5 (best)
FOM Feeding Subscale
Fully dependent
Partially dependent
Independent w/device
Fully independent
FOM Locomotion Subscale
Fully dependent
Partially dependent
Independent w/device
Fully independent
FOM Expression/Communication Subscale
Fully dependent
Partially dependent
Independent w/device
Fully independent"|Up to 1 year follow-up|Please see Outcome Measure Description [above] for exact measure(s) utilized, including measurement scale(s).||units on a scale||Standard Deviation|Mean
852914|NCT01594385|Other Pre-specified|Bowel Obstruction|Determination of bowel obstruction during the entire available study follow-up period|Up to 1 year follow-up|||Bowel obstruction|||Number
852915|NCT01594385|Other Pre-specified|Infection / Abscess / Sepsis|Assessment of any infection, abscess, or sepsis during the initial and the follow-up periods|Up to 1 year|||Total events|||Number
852916|NCT01594385|Other Pre-specified|Ventral Hernia|Determination of ventral hernia presence during follow-up visits|Up to 1 year follow-up|||Hernia|||Number
852917|NCT01594385|Other Pre-specified|Enterocutaneous and Other Fistula|Determination of enterocutaneous/other fistula among study patients during the hospitalization and the follow-up interval|Up to 1 year post-injury|||Total events|||Number
852918|NCT01594385|Other Pre-specified|Patient Mortality|Assessment of patient mortality at 28 days, with subsequent determination of survival (i.e., patient status at last known follow-up)|28 days & end of follow-up|Note: Both mortalities in the Seprafilm group involved withdrawal of care as per previously stated patient wishes.||Mortalities|||Number
850522|NCT01299610|Secondary|Pharmacodynamics Endpoint: Skin Thickness and Other Markers of Atopic Dermatitis|A 4 millimeter (mm) punch skin biopsy was taken pre- and post-treatment (Day 1 and Day 21) from each of the 3 index lesions. The results were not analyzed for this outcome measure.|Day 1 and Day 22|Efficacy Population|||||
850523|NCT01299610|Secondary|Pharmacokintics Parameter: Area Under Curve (AUC) of GW870086|The area under the plasma concentration-time curve to the last quantifiable concentration (AUC[0-t]) and area under the plasma concentration-time curve over the dosing interval (AUC[0-tou]) was planned to be determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. The pharmacokinetic parameters were planned to be calculated by standard non-compartmental analysis using Win-Nonlin Pro-Version 5.2 or higher. AUC was not analysed because the plasma concentrations were not quantifiable.|Day 7, 14 and 21|Pharmacokinetics population|||||
850524|NCT01299610|Secondary|Pharmacokinetic Parameter: Time of Occurrence of Cmax (Tmax) of GW870086|Tmax was planned to be determined directly from the raw concentration-time data. The pharmacokinetic parameters were planned to be calculated by standard non-compartmental analysis using Win-Nonlin Pro-Version 5.2 or higher. Tmax was not analysed because the plasma concentrations were not quantifiable.|Day 7, 14 and 21|Pharmacokinetics population|||||
850525|NCT01299610|Secondary|Pharmacokinetic Parameters: Maximum Observed Concentration (Cmax) of GW870086X|Cmax was planned to be determined directly from the raw concentration-time data. The pharmacokinetic parameters were planned to be calculated by standard non-compartmental analysis using Win-Nonlin Pro-Version 5.2 or higher. Cmax was not analysed because the plasma concentrations were not quantifiable.|Day 7, 14 and 21|Pharmacokinetic population was defined as participants in the All Subjects population for whom a pharmacokinetic sample was obtained and analyzed.|||||
850526|NCT01299610|Secondary|Number of Participants With Abnormal Vital Signs (Systolic and Diastolic Blood Pressure and Pulse Rate) of PCI|The PCI ranges (low and high) of the vital sign parameters were for systolic blood pressure (<85 and >160 millimeter of mercury [mmHg]), diastolic blood pressure (<45 and >100 mmHg) and heart rate (<40 and >110 beats per minute). Only those parameters for which at least one value of PCI was reported are summarized. There were no values of PCI in vital signs parameters over the course of the study.|Up to Day 21|All subject population||Participants|||Number
850527|NCT01299610|Secondary|Number of Participants With Abnormal Electrocardiogram (ECG) of PCI|12-lead ECG was obtained. The standard ECG criteria of PCI were 1) absolute QTc Interval, > 450 milliseconds (msec), 2) increase from Baseline in QTc > 60 msec 3) absolute PR Interval, <110 and >220 msec, 4) absolute QRS Interval, < 75 and >110 msec. The number of participants with PCI ECG findings at any visit during the treatment and follow-up were reported.|Up to Day 21|All subject population||Participants|||Number
850528|NCT01299610|Secondary|Number of Participants With Abnormal Hematology and Clinical Chemistry Parameters of Potential Clinical Importance (PCI)|Laboratory ranges of PCI represented as multiplier of lower limit of normal [LLN]; Multipliers of upper limit of normal (ULN). Laboratory ranges of PCI for white blood cell count (0.67×LLN; 1.82×ULN), neutrophil count (0.83×ULN), hemoglobin for male (1.03×ULN) and for female (1.13×ULN), hematocrit for male (1.02×ULN) for female (1.17×ULN), platelet count (0.67×LLN; 1.57), lymphocytes (0.81×LLN), albumin (0.86 ×LLN), calcium (0.91×LLN; 1.06×ULN), glucose (0.71×LLN; 1.41×ULN), potassium (0.86×LLN; 1.10×ULN), sodium (0.96×LLN; 1.03×ULN), aspartate amino transferase (>= 2x ULN), alanine transaminase (>=2x ULN), alkaline Phosphatase (>=2x ULN), total bilirubin (>=1.5x ULN). Only those parameters for which at least one value of PCI was reported are summarized. The number of participants with PCI hematology and clinical chemistry findings at any visit during the treatment and follow-up were reported.|Up to Day 21|All subject population||Participants|||Number
850529|NCT01299610|Secondary|Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE was defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE include AEs those result in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. No SAEs were reported in this study. Number of participants with AEs and SAEs were reported.|Upto Day 21|All Subjects Population was defined as all participants who had at least one application of placebo, GW870086X 0.2%, GW 870086X 2% or FP 0.05% cream.||Participants|||Number
850530|NCT01299610|Secondary|Number of Investigators Global Assessment (IGA) Responders on Days 2, 3, 7, 14 and 22|Three target lesions were selected and each of the 3 target lesions were assessed separately using the IGA. The IGA was carried out by a trained dermatologist and score ranged from 0 to 5. The detailed IGA scale is as: 0-Clear: No inflammatory signs of atopic dermatitis, 1- Almost clear: Just perceptible erythema and just perceptible apulation/infiltration, 2-Mild: Mild erythema and mild papulation/infiltration, 3-Moderate: Moderate erythema, and moderate papulation/infiltration, 4-Severe: Severe erythema and severe papulation/infiltration, 5-Very Severe: Very severe erythema, and very severe papulation/infiltration with oozing/crusting. The participant was considered as responder if each lesion at timepoint, IGA score reduced by 1 grade and improved from Baseline by 2 grades.|Days 2, 3, 7, 14 and 22|Efficacy population||Participants|||Number
850531|NCT01299610|Secondary|Change From Baseline TIS Scores Between GW870086X (0.2% and 2%) Versus Placebo on Days 2, 3, 7 and 14|Three target lesions were selected and each of the 3 target lesions were assessed separately using the TIS for erythema, oedema/papulation, and excoriation using a score of 0 - 3 as 0 = absent, 1 = mild, 2 = moderate, 3 = severe. Each participant had at least 3 index lesions (=> 1square centimeter in size) with a sum score of =>4 and =< 6 for erythema, oedema/populations and excoriations using the TIS rating scale at screening. The index lesions represented common lesions i.e. not the most or least severe lesions. The total TIS score for a lesion was calculated as the sum of each of the component scores i.e. may range from 0 (no symptoms) to 9 (severe symptoms). The values of Day 1 assessments were considered as Baseline values. The change from Baseline was calculated by subtracting the Baseline TIS score from Day 22 values TIS score.|Days 2, 3, 7, and 14 of each treat|Efficacy Population||Score on scale||Standard Error|Least Squares Mean
850532|NCT01299610|Primary|Change From Baseline Three Item Severity (TIS) Scores Between GW870086 (0.2% and 2%) Versus Placebo at Day 22|Three target lesions were selected and each of the 3 target lesions were assessed separately using the TIS for erythema, oedema/papulation, and excoriation using a score of 0 - 3 as 0 = absent, 1 = mild, 2 = moderate, 3 = severe. Each participant had at least 3 index lesions (=> 1square centimeter in size) with a sum score of =>4 and =< 6 for erythema, oedema/populations and excoriations using the TIS rating scale at screening. The index lesions represented common lesions i.e. not the most or least severe lesions. The total TIS score for a lesion was calculated as the sum of each of the component scores i.e. ranging from 0 (no symptoms) to 9 (severe symptoms). The values of Day 1 assessments were considered as Baseline values. The change from Baseline was calculated by subtracting the Baseline TIS score from Day 22 TIS score.|Baseline (Day 1) and Day 22|The Efficacy Population was defined as participants in the ‘All Subjects’ population with at least one post dose TIS assessment.||Score on scale||Standard Error|Least Squares Mean
850535|NCT01278394|Secondary|Length of Time to Clinical Evaluation of Clear or at Least 5 mm of CNG|Length of time to clinical evaluation of clear or at least 5 mm of CNG.|Baseline to 360|Efficacy data were analyzed for the ITT population. For efficacy variables, the LOCF was used to impute missing observations.||days||95% Confidence Interval|Mean
850538|NCT01278394|Secondary|Mycological Evaluations (Negative KOH and Negative Fungal Culture) Compared to Baseline|Number of subjects with negative KOH, and number of subjects with negative fungal cultures.|Day 180|Efficacy data were analyzed for the ITT population. For efficacy variables, the LOCF was used to impute missing observations.||participants|||Number
850539|NCT01278394|Secondary|Mycological Evaluations (Negative Potassium Hydroxide (KOH) and Negative Fungal Culture) Compared to Baseline|Number of subjects with negative KOH, and number of subjects with negative fungal cultures.|Day 90|Efficacy data were analyzed for the ITT population. For efficacy variables, the LOCF was used to impute missing observations.||participants|||Number
850540|NCT01278394|Secondary|Clear Nail Growth of the Targeted Toenail|Clear nail was measured on digital images as the distance in millimeters from the proximal nail fold to the proximal limit of the disease as marked by the Investigator. New Clear Nail Growth (CNG) was calculated from the clear nail measurements.|Day 360|Efficacy data were analyzed for the ITT population. For efficacy variables, the LOCF was used to impute missing observations.||millimeters||95% Confidence Interval|Mean
850541|NCT01278394|Primary|Clinical Evidence of Complete Clearance of the Treatment-targeted Great Toenail Plus a Negative Fungal Culture at Day 360|Proportion of subjects with a clinical assessment of a clear (completely normal) nail unit plus a negative fungal culture from the treatment-targeted toenail at Day 360.|Day 360|Efficacy data were analyzed for the ITT population. For efficacy variables, the last observation was carried forward (LOCF) to impute missing observations.||participants|||Number
850665|NCT01128621|Primary|Number of Participants With Relationship Between GSK1292263 Drug Exposures and Pharmacodynamic Parameters (Part B)|Data was not collected for this outcome measure.|At pre-breakfast on Days -1 and 14, and then at 0.5, 1, 1.5, 2 and 3 hours post dose|PD Population. No data was collected for this outcome measure.|||||
853671|NCT00069238|Secondary|Clinical Response|Response was measured by the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas. Complete remission (CR) is complete disappearance of all detectable clinical and radiographic evidence of disease. Complete response unconfirmed (Cru)is as per complete remission criterion except that if a residual node is greater than 1.5cm, it must have decreased by greater than 75% in the sum of the products of the perpendicular diameters (SPD). Partial response (PR) is ≥50% decrease in the SPD of 6 largest dominant nodes or nodal masses. Progressive disease (PD) is ≥50% increase from the nadir in the SPD of any previously identified abnormal node for PRS or non-responders. Stable disease (SD) is less than a PR but not progressive disease.|For patients with response:Restage sites of disease every (q) 3 months for the first year, then q4 months for the second year, and then q6 months for the next 3 years, and yearly thereafter. The timing for these visits may be adjusted + 2 months.|||Participants|||Count of Participants
853672|NCT00069238|Primary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|67 months and 9 days|||Participants|||Count of Participants
853673|NCT00069238|Primary|Maximum Tolerated Dose (MTD) of Alemtuzumab|MTD was achieved by increasing doses of Alemtuzumab on three cohorts. Cohort 1 received 30mg of Alemtuzumab, cohort 2 received 60mg of Alemtuzumab, and cohort 3 received 90mg of Alemtuzumab intravenously every 3 weeks for up to 6 cycles. The MTD reflects the highest dose of Alemtuzumab in which no more than 1 of 6 participants entered at a specific dose level experienced a dose limiting toxicity (DLT).|Evaluation of dose limiting toxicity was done at the end of each cycle or every 21 days.|||mg|||Number
853674|NCT00064753|Secondary|Renal Artery Revascularization|censored at 3 months after return to dialysis|Up to 6 years (mean 4 years)|||participants|||Number
853675|NCT00064753|Secondary|Abdominal Aortic Aneurysm Repair|censored at 3 months after return to dialysis|Up to 6 years (mean 4 years)|||participants|||Number
853676|NCT00064753|Secondary|Carotid Endarterectomy or Angioplasty|censored at 3 months after return to dialysis|Up to 6 years (mean 4 years)|||participants|||Number
853677|NCT00064753|Secondary|Lower Extremity Peripheral Arterial Disease (PAD)|censored at 3 months after return to dialysis|Up to 6 years (mean 4 years)|||participants|||Number
853678|NCT00064753|Secondary|Coronary Artery Revascularization|censored at 3 months after return to dialysis|Up to 6 years (mean 4 years)|||participants|||Number
853679|NCT00064753|Secondary|CVD Death|censored at 3 months after return to dialysis|Up to 6 years (mean 4 years)|P was calculated with stratified proportional hazards models stratified by country||participants|||Number
853680|NCT00064753|Secondary|Resuscitated Sudden Death (RSD)|censored at 3 months after return to dialysis|Up to 6 years (mean 4 years)|||participants|||Number
853681|NCT00064753|Secondary|Fatal/Non-fatal Stroke|censored at 3 months after return to dialysis|Up to 6 years (mean 4 years)|||participants|||Number
853682|NCT00064753|Secondary|Fatal/Non-fatal Myocardial Infarction (MI)|censored at 3 months after return to dialysis|Up to 6 years (mean 4 years)|||participants|||Number
853683|NCT00064753|Secondary|Mortality (All-cause)|censored at 3 months after return to dialysis|Up to 6 years (mean 4 years)|||participants|||Number
853684|NCT00064753|Secondary|Renal Graft Failure||Up to 6 years (mean 4 years)|Intention-to-treat||participants|||Number
853685|NCT00064753|Primary|Recurrent or de Novo Arteriosclerotic Cardiovascular Disease (CVD) Defined as the Occurrence of Non-fatal or Fatal Arteriosclerotic Outcomes Including Coronary Heart, Cerebrovascular, and Peripheral Vascular Disease Events||Up to 6 years (mean 4 years)|Censored at 3 months after return to dialysis||participants|||Number
853690|NCT00045708|Secondary|Percent of Subjects With 6M Progression Free Survival at the Phase 2 Arm of Study|subjects who are progression free at 6 month scan|6 months|19 patients treated at the MTD from during Phase 2 and 4 patients treated at the MTD during the Phase 1 nonP450 arm 2 were included in the response analysis.||percent of patients||95% Confidence Interval|Number
853691|NCT00045708|Secondary|The Duration of Progression Free Survival (Phase 2)|only patients treated on the nonP450 MTD|1.5 years|19 patients treated at the MTD from during Phase 2 and 4 patients treated at the MTD during the Phase 1 nonP450 arm 2 were included in the response analysis.||months||95% Confidence Interval|Median
853692|NCT00045708|Secondary|Duration of Overall Survival||1.5 years|||months||95% Confidence Interval|Median
853693|NCT00045708|Primary|Grade 3 and 4 Toxicity (NCI Common Terminology Criteria for Adverse Events Associated With BMS-247550 Treatment in at Least 5% of Patients|Proportion of patients with serious or life threatening toxicities in at least 5% of patients|Up to 30 days post treatment|||Participants|||Count of Participants
853766|NCT02287025|Primary|Proportion of Patients Who Discontinue Prior to Documented Progression of Disease (PD) or Death||Up to 1 year|The study was pre-maturely terminated. No data were collected from participants for this assessment.|||||
850686|NCT01128621|Primary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings (Part B)|ECGs were taken at Screening, pre-breakfast on Day -1 and at Follow-up. On Days 1, 7 and 14 ECGs were taken pre-breakfast (fasting) and at 1, 2, 4, 6, 8, 12 and 24hours post-dose. Triplicate ECGs were taken at the pre-breakfast time point, and single assessments were taken at all other times. ECGs were taken in supine position. The data has been presented as abnormal- not clinically significant (NCS) and abnormal-clinically significant (CS).|Up to 10 days after discharge (Day 15) in Part B|Safety Population. Only those participants available at the specified time points were analyzed.||Participants|||Count of Participants
850634|NCT01204255|Secondary|Side Effects||3 months|||Side effects|||Number
850635|NCT01204255|Primary|Lorazepam, Diphenyhydramine, Haloperidol Absorption|Level of lorazepam absorption measured by the serum concentration of the drug|4 hours|||ng/ml||Standard Deviation|Mean
850687|NCT01128621|Primary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings (Part A)|ECGs were taken at Screening, pre-breakfast on Day -1, on Day 1 (pre-breakfast, 1 hour, 2, 3, 4, 6, 8, 13, 24hours post-dose), and at follow-up. Assessments were made in triplicate on Day 1 at the pre-breakfast time point, and single assessments were made at all other times. ECGs were taken in supine position. The data has been presented as abnormal- not clinically significant (NCS) and abnormal-clinically significant (CS).|Up to 10 days after discharge (Day 2) in Part A|Safety Population.||Participants|||Count of Participants
850653|NCT01177735|Secondary|Gene Expression Profiling (GEP) Changes Exerted Within 48 Hours of Initiation 3 Concurrent Days of Exposure to Lenalidomide.|Gene expression profiling at 48 hours after initiation of lenalidomide|48 hours||||||
850654|NCT01177735|Secondary|Gene Expression Profiling (GEP) Changes Exerted Within 48 Hours of Initiation of Daily Pomalidomide Dosing.|Gene expression profiling at baseline and at 48 hours after initiation of pomalidomide|48 hours||||||
850655|NCT01177735|Secondary|Response Rate (CR, n-CR, VGPR) and Duration of Response After Pomalidomide Therapy.|Response rate (CR, n-CR, VGPR) Duration of response rate after initiation of pomalidomide therapy|1 year following initiation of pomalidomide therapy||||||
850656|NCT01177735|Primary|Progression-free Survival (PFS) After Initiation of Pomalidomide Therapy|Progression -free survival (PFS) after initiation of pomalidomide therapy. Progressive disease is defined as increase of > 25% from lowest response value in any one or more of the following: Serum M-component and/or (the absolute increase must be > 0.5 g/dL); Urine M-component and/or (the absolute increase must be > 200 mg/24 h); Only in patients without measurable serum and urine M-protein levels; the difference between involved and uninvolved FLC levels. The absolute increase must be > 10 mg/dL; Bone marrow plasma cell percentage; the absolute percentage must be > 10%; Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcaemia (corrected serum calcium > 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder.|1 year following initiation of pomalidomide therapy|||percentage of participants|||Number
850666|NCT01128621|Primary|Change From Baseline in Weighted Mean for Insulin Value (Part B)|Baseline was considered to be Day -1 pre-breakfast value. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value was missing, the change from Baseline is set to missing as well. If measurements were taken in triplicate, then the mean of the triplicate measurements was used as the Baseline. AUC with respect to that time interval was calculated using the linear trapezoidal rule. The weighted mean was determined by dividing the AUC by the observed length of the collection interval (time of last assessment – time of first assessment in hours). In order for the AUC to be calculated, the first and last time points and at least one additional assessment falling between the two must be non-missing.|Baseline and at pre-breakfast on Days -1 and 14, and then at 0.5, 1, 1.5, 2 and 3 hours post dose.|PD Population||pmol/L||95% Confidence Interval|Mean
850667|NCT01128621|Primary|Change From Baseline in Weighted Mean for Glucose Value (Part B)|Baseline was considered to be Day -1 pre-breakfast value. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value was missing, the change from Baseline is set to missing as well. If measurements were taken in triplicate, then the mean of the triplicate measurements was used as the Baseline. Weighted mean were assessed for (0-12) and (0-24). AUC with respect to that time interval was calculated using the linear trapezoidal rule. The weighted mean was determined by dividing the AUC by the observed length of the collection interval (time of last assessment – time of first assessment in hours). In order for the AUC to be calculated, the first and last time points and at least one additional assessment falling between the two must be non-missing.|Baseline and at pre-breakfast on Days -1 and 14, and then at 0.5, 1, 1.5, 2 and 3 hours post dose.|PD Population.||mmol/L||95% Confidence Interval|Mean
850668|NCT01128621|Primary|Mean Post Meal Insulin Value (Part B)|Blood samples were collected on Days -1 and 14, post-breakfast at 0.5, 1, 1.5, 2 and 3 hours post dose. For lunch (approximately 4 hours post morning dose) samples were collected at the following times after starting each meal: 0.5, 1, 1.5, 2 and 3 hours. For the evening meal (approximately 10 hours post morning dose), samples were taken at 0.5, 1, 1.5, 2 and 3 hours post dinner.|At pre-breakfast on Days -1 and 14, and then at 0.5, 1, 1.5, 2 and 3 hours post dose.|PD Population.||pmol/L||95% Confidence Interval|Mean
850669|NCT01128621|Primary|Mean Post Meal Glucose Value (Part B)|Blood samples were collected on Days -1 and 14, post-breakfast at 0.5, 1, 1.5, 2 and 3 hours post dose. For lunch (approximately 4 hours post morning dose) samples were collected at the following times after starting each meal: 0.5, 1, 1.5, 2 and 3 hours. For the evening meal (approximately 10 hours post morning dose), samples were taken at 0.5, 1, 1.5, 2 and 3 hours post dinner.|At pre-breakfast on Days -1 and 14, and then at 0.5, 1, 1.5, 2 and 3 hours post dose.|PD Population.||mmol/L||95% Confidence Interval|Mean
850670|NCT01128621|Primary|Change From Baseline in Mean Fasted Insulin Value (Part B)|Baseline was considered to be Day -1 pre-breakfast value. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value was missing, the change from Baseline is set to missing as well. If measurements were taken in triplicate, then the mean of the triplicate measurements was used as the Baseline.|Baseline and at pre-breakfast on Days -1 and 14, and then at 0.5, 1, 1.5, 2 and 3 hours post dose.|PD Population.||pmol/L||95% Confidence Interval|Mean
850671|NCT01128621|Primary|Change From Baseline in Mean Fasted Glucose Value (Part B)|Baseline was considered to be Day -1 pre-breakfast value. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value was missing, the change from Baseline is set to missing as well. If measurements were taken in triplicate, then the mean of the triplicate measurements was used as the Baseline.|Baseline and at pre-breakfast on Days -1 and 14, and then at 0.5, 1, 1.5, 2 and 3 hours post dose.|PD Population.||mmol/L||95% Confidence Interval|Mean
850672|NCT01128621|Primary|Change From Baseline in Mean Fasted Insulin Value (Part A)|Baseline was considered to be Day 1 pre-breakfast. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value was missing, the change from Baseline is set to missing as well. If measurements were taken in triplicate, then the mean of the triplicate measurements was used as the Baseline.|Baseline and at pre-breakfast on Day 1 and 24 hours post-dose.|PD Population. Only those participants with data available at the indicated time points were analyzed.||picomoles per liter (pmol/L)||Geometric Coefficient of Variation|Geometric Mean
850673|NCT01128621|Primary|Change From Baseline in Mean Fasted Glucose Value (Part A)|Baseline was considered to be Day 1 pre-breakfast. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value was missing, the change from Baseline is set to missing as well. If measurements were taken in triplicate, then the mean of the triplicate measurements was used as the Baseline.|Baseline and at pre-breakfast on Day 1 and 24 h post-dose.|The Pharmacodynamic (PD) Population included participants from the Safety Population who had any PD parameter estimated. Only those participants with data available at the indicated time points were analyzed.||millimoles per liter (mmol/L)||Geometric Coefficient of Variation|Geometric Mean
850674|NCT01128621|Primary|Mean Accumulation Ratio by AUC (0-10), AUC (0-24) and Cmax for GSK1292263 (Part B)|Accumulation ratio (Ro) was derived as: Ro = Day 14 morning AUC(0-10)/Day 1 morning AUC(0-10) (for BID regimens only). Ro = Day 14 AUC(0-24)/Day 1 AUC(0-24) (for both BID and once daily regimens). Accumulation ratio (RCmax)= Day 14 Cmax/Day 1 Cmax. RCmax was not computed for each dosing period (morning and evening).|On Days 1 and 14, at immediately pre-morning dose, 1, 2, 4, 6, 8, 10, 11, 12, 14, 16, 18, 24 and 48 hours post-morning dose.|PK Population. Only those participants with data available at the indicated time points were analyzed.||Ratio||90% Confidence Interval|Mean
850675|NCT01128621|Primary|T1/2 Following Repeat Dose of GSK1292263 (Part B)|"Outcome measure was added with caveat as data permits. The data for T1/2 was not collected."|On Days 1 and 14, at immediately pre-morning dose, 1, 2, 4, 6, 8, 10, 11, 12, 14, 16, 18, 24 and 48 hours post-morning dose. On Day 7, at pre-dose (post-breakfast), 1, 2, 4 (pre-lunch), 6 and 10 (immediately post-dinner, pre-dose for BID regimen).|PK population|||||
850676|NCT01128621|Primary|AUC From Time Zero (Pre-dose) to 10 Hours [AUC (0-10)] and AUC (0-24) Following Repeat Dose of GSK1292263 (Part B)|Serial blood samples for the determination of the PK of GSK1292263 were collected on Days 1, 7 and 14. Blood samples for PK were collected on Days 1 and 14, at immediately pre-morning dose, 1, 2, 4, 6, 8, 10, 11, 12, 14, 16, 18, 24 and 48 hours post-morning dose. On Day 7, blood samples for PK were collected at pre-dose (post-breakfast), 1, 2, 4 (pre-lunch), 6 and 10 (immediately post-dinner, pre-dose for BID regimen). When planned PK sampling resulted in multiple samples at the same time point, only one sample was collected. The PK parameters were calculated by standard non-compartmental analysis. AUC (0-10) and AUC (0-24) were determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations.|On Days 1 and 14, at immediately pre-morning dose, 1, 2, 4, 6, 8, 10, 11, 12, 14, 16, 18, 24 and 48 hours post-morning dose. On Day 7, at pre-dose (post-breakfast), 1, 2, 4 (pre-lunch), 6 and 10 (immediately post-dinner, pre-dose for BID regimen).|PK Population. Only those participants available at the specified time points were analyzed.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
850677|NCT01128621|Primary|Tmax and Tlag Following Repeat Dose of GSK1292263 (Part B)|Serial blood samples for the determination of the PK of GSK1292263 were collected on Days 1, 7 and 14. Blood samples for PK were collected on Days 1 and 14, at immediately pre-morning dose, 1, 2, 4, 6, 8, 10, 11, 12, 14, 16, 18, 24 and 48 hours post-morning dose. On Day 7, blood samples for PK were collected at pre-dose (post-breakfast), 1, 2, 4 (pre-lunch), 6 and 10 (immediately post-dinner, pre-dose for BID regimen). When planned PK sampling resulted in multiple samples at the same time point, only one sample was collected. The PK parameters were calculated by standard non-compartmental analysis. Tmax was determined directly from the raw concentration-time data. Tlag was determined as the time of the sample preceding the first quantifiable concentration, on Day 1 only.|On Days 1 and 14, at immediately pre-morning dose, 1, 2, 4, 6, 8, 10, 11, 12, 14, 16, 18, 24 and 48 hours post-morning dose. On Day 7, at pre-dose (post-breakfast), 1, 2, 4 (pre-lunch), 6 and 10 (immediately post-dinner, pre-dose for BID regimen).|PK Population. Only those participants available at the specified time points were analyzed.||hour||Full Range|Median
850678|NCT01128621|Primary|Cmax Following Repeat Dose of GSK1292263 (Part B)|Serial blood samples for the determination of the PK of GSK1292263 were collected on Days 1, 7 and 14. Blood samples for PK were collected on Days 1 and 14, at immediately pre-morning dose, 1, 2, 4, 6, 8, 10, 11, 12, 14, 16, 18, 24 and 48 hours post-morning dose. On Day 7, blood samples for PK were collected at pre-dose (post-breakfast), 1, 2, 4 (pre-lunch), 6 and 10 (immediately post-dinner, pre-dose for BID regimen). When planned PK sampling resulted in multiple samples at the same time point, only one sample was collected. The PK parameters were calculated by standard non-compartmental analysis. Cmax was determined directly from the raw concentration-time data.|On Days 1 and 14, at immediately pre-morning dose, 1, 2, 4, 6, 8, 10, 11, 12, 14, 16, 18, 24 and 48 hours post-morning dose. On Day 7, at pre-dose (post-breakfast), 1, 2, 4 (pre-lunch), 6 and 10 (immediately post-dinner, pre-dose for BID regimen).|PK Population. Only those participants available at the specified time points were analyzed.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
850679|NCT01128621|Primary|Terminal Phase Half-life (t1/2) Following a Single Dose of GSK1292263 (Part A)|"Outcome measure was added with caveat as data permits. The data for t1/2 was not collected."|On Day 1 Immediately pre-dose (time 0) and at 0.5, 1, 2, 3, 4, 6, 8, 13, 24 and 48 hours post-dose.|PK Population|||||
850680|NCT01128621|Primary|Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC [0-inf]) Following a Single Dose of GSK1292263 (Part A)|"Outcome measure was added with caveat as data permits. The data for AUC (0-inf) was not collected."|On Day 1 Immediately pre-dose (time 0) and at 0.5, 1, 2, 3, 4, 6, 8, 13, 24 and 48 hours post-dose.|PK Population|||||
850681|NCT01128621|Primary|Volume of Distribution (V/F) (Part A)|"Outcome measure was added with caveat as data permits. The data for V/F was not collected."|On Day 1 Immediately pre-dose (time 0) and at 0.5, 1, 2, 3, 4, 6, 8, 13, 24 and 48 hours post-dose.|PK Population|||||
850682|NCT01128621|Primary|Apparent Clearance Following Oral Dosing (CL/F) of GSK1292263 (Part A)|"Outcome measure was added with caveat as data permits. The data for CL/F was not collected."|On Day 1 Immediately pre-dose (time 0) and at 0.5, 1, 2, 3, 4, 6, 8, 13, 24 and 48 hours post-dose.||||||
850683|NCT01128621|Primary|Lag Time Before Observation of Drug Concentrations in Sampled Matrix (Tlag) and Time of Occurrence of Cmax (Tmax) Following a Single Dose of GSK1292263 (Part A)|Blood samples for the determination of PK were collected on Day 1 Immediately pre-dose (time 0) and at 0.5, 1, 2, 3, 4, 6, 8, 13, 24 and 48 hours post-dose. PK samples for 2 participants were not analyzed. The PK parameters were calculated by standard non-compartmental analysis. Tmax was determined directly from the raw concentration-time data. Tlag was determined as the time of the sample preceding the first quantifiable concentration, on Day 1 only.|On Day 1 Immediately pre-dose (time 0) and at 0.5, 1, 2, 3, 4, 6, 8, 13, 24 and 48 hours post-dose.|PK Population. Only those participants with data available at the indicated time points were analyzed.||hour||Full Range|Median
850684|NCT01128621|Primary|Maximum Observed Concentration (Cmax) Following a Single Dose of GSK1292263 (Part A)|Blood samples for the determination of PK were collected on Day 1 Immediately pre-dose (time 0) and at 0.5, 1, 2, 3, 4, 6, 8, 13, 24 and 48 hours post-dose. PK samples for participants were not analyzed. The PK parameters were calculated by standard non-compartmental analysis. Cmax was determined directly from the raw concentration-time data.|On Day 1 Immediately pre-dose (time 0) and at 0.5, 1, 2, 3, 4, 6, 8, 13, 24 and 48 hours post-dose.|PK Population. Only those participants with data available at the indicated time points were analyzed.||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
850685|NCT01128621|Primary|Area Under the Concentration-time Curve From Zero (Pre-dose) to 24 Hours [AUC (0-24)] and AUC From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC [0-last)] Following a Single Dose of GSK1292263 (Part A)|Blood samples for the determination of pharmacokinetics (PK) were collected on Day 1 Immediately pre-dose (time 0) and at 0.5, 1, 2, 3, 4, 6, 8, 13, 24 and 48 hours post-dose. PK samples for 2 participants were not analyzed. The PK parameters were calculated by standard non-compartmental analysis. AUC (0-last) and AUC (0-24) were determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations.|On Day 1 Immediately pre-dose (time 0) and at 0.5, 1, 2, 3, 4, 6, 8, 13, 24 and 48 hours post-dose.|The PK Population included participants from the Safety Population who had any PK parameter estimated. Only those participants with data available at the indicated time points were analyzed.||nanograms hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
850688|NCT01128621|Primary|Number of Participants With Abnormal Vital Signs of PCI (Part B)|Assessment of vital signs (including systolic and diastolic blood pressure and heart rate) was performed at Screening, pre-breakfast on Days -1 to 14 in a fasting state early in the morning (prior to morning dosing on Days 1-14), and at Follow-up. On Days 1, 7 and 14, they were taken at 1, 3, 6, 9, 12 and 24 hours after the morning dose. At each time point, assessment was performed after resting in a supine or semi-supine position for at least 10 minutes.|Up to 10 days after discharge (Day 15) in Part B|Safety Population.||Participants|||Count of Participants
850689|NCT01128621|Primary|Number of Participants With Abnormal Vital Signs of PCI (Part A)|Assessment of vital signs (including systolic, diastolic blood pressure and heart rate) was performed at one time point at Screening, at follow-up and pre-breakfast on Day -1. On Day 1, they were taken at pre-breakfast, 1 hour, 3, 4, 6, 10, 16 and 24 hours post-dose. Assessments were made in triplicate at the pre-breakfast time point, and single assessments were made at all other times. Assessments were performed after resting in a supine or semi-supine position for at least 10 minutes. PCI value of systolic blood pressure: <85 and >160 millimeter of mercury (mmHg). PCI value of diastolic blood pressure: <45 and >100 mmHg. PCI value of heart rate: <40 and >110 beats per minute.|Up to 10 days after discharge (Day 2) in Part A|Safety Population||Participants|||Count of Participants
850690|NCT01128621|Primary|Mean Value of Urine Specific Gravity (Part B)|Urine samples were collected at screening, on Day -2, and on Days 1, 7, 15 and at follow-up. Urinalysis parameter include urine specific gravity. Urinary specific gravity is a measure of the concentration of solutes in the urine . It measures the ratio of urine density compared with water density and provides information on the kidney's ability to concentrate urine .|Up to 10 days after discharge (Day 15) in Part B|Safety Population. Only those participants available at the specified time points were analyzed.||Ratio||Standard Deviation|Mean
850691|NCT01128621|Primary|Mean Value of Urine Specific Gravity (Part A)|Urine samples were collected at screening, Day -1, at 24hr post- dose (Day 2), and at follow-up. Urinalysis parameter include urine specific gravity. Urinary specific gravity is a measure of the concentration of solutes in the urine . It measures the ratio of urine density compared with water density and provides information on the kidney's ability to concentrate urine .|Up to 10 days after discharge (Day 2) in Part A|Safety Population. Only those participants with data available at the indicated time points were analyzed.||Ratio||Standard Deviation|Mean
850692|NCT01128621|Primary|Mean Value of Urine pH (Part B)|Urine samples were collected at screening, on Day -2, and on Days 1, 7, 15 and at follow-up. Urinalysis parameters included urine pH assessed using dipstick analysis. pH is calculated on a scale of 0 to 14, such that, the lower the number, more acidic the urine and higher the number, more alkaline the urine with 7 being neutral.|Up to 10 days after discharge (Day 15) in Part B|Safety Population. Only those participants available at the specified time points were analyzed.||pH||Standard Deviation|Mean
850693|NCT01128621|Primary|Mean Value of Urine pH (Part A)|Urine samples were collected at screening, Day -1, at 24hr post- dose (Day 2), and at follow-up. Urinalysis parameters included urine pH assessed using dipstick analysis. pH is calculated on a scale of 0 to 14, such that, the lower the number, more acidic the urine and higher the number, more alkaline the urine with 7 being neutral.|Up to 10 days after discharge (Day 2) in Part A|Safety Population||pH||Standard Deviation|Mean
850694|NCT01128621|Primary|Mean Value of Urine Albumin (Part B)|Urine samples were collected at screening, on Day -2, and on Days 1, 7, 15 and at follow-up. Urine albumin was assessed using quantitative analysis.|Up to 10 days after discharge (Day 15) in Part B|Safety Population. Only those participants available at the specified time points were analyzed.||mg/L||Standard Deviation|Mean
850695|NCT01128621|Primary|Mean Value of Urine Albumin at Follow up (Part A)|Urine samples were collected at screening, Day -1, at 24hr post- dose (Day 2), and at follow-up. Urine albumin was assessed using quantitative analysis.|Up to 10 days after discharge (Day 2) in Part A|Safety Population. Only those participants with data available at the indicated time points were analyzed.||milligrams per liter (mg/L)||Standard Deviation|Mean
850696|NCT01128621|Primary|Number of Participants With Abnormal Urinalysis Data Values (Part B)|Urinalysis parameters: Urine occult blood, Urine glucose, Urine ketones, Urine protein, White blood cells were assessed for abnormal findings by dipstick analysis. The abnormal findings were presented as trace, 1+, 2+ and 3+. Trace indicates lowest concentration of the mentioned parameters in urine and 3+ indicates highest concentration. Concentration of 3+ indicates worse outcome.|Up to 10 days after discharge (Day 15) in Part B|Safety Population. Only those participants available at the specified time points were analyzed.||Participants|||Count of Participants
850697|NCT01128621|Primary|Number of Participants With Abnormal Urinalysis Data Values by Dipstick Method (Part A)|Urinalysis parameters: Urine occult blood, Urine Glucose, Urine ketones and Urine protein were assessed for abnormal findings by dipstick analysis. The abnormalities were presented as trace, 1+, 2+ and 3+. Trace indicates lowest concentration of the mentioned parameters in urine and 3+ indicates highest concentration. Concentration of 3+ indicates worse outcome.|Up to 10 days after discharge (Day 2) in Part A|Safety Population||Participants|||Count of Participants
850698|NCT01128621|Primary|Number of Participants With Abnormal Clinical Chemistry Values of PCI (Part B)|Blood samples for chemistry assessments were collected at screening, on Day -2 (non-fasting), and prior to breakfast (early in the morning, fasting) on Days 1, 7, and on Day 15 prior to checkout, (=24hrs post-dose), and at follow-up. Clinical chemistry parameters: Aspartate amino transferase (unit: international unit per liter [IU/L]) and Total bilirubin (unit: micromoles per liter (µmol/L) were assessed for abnormal values of PCI. For aspartate aminotransferase the PCI range was >=2 x ULN (high). For total bilirubin the PCI range was >=1.5 x ULN (high).|Up to 10 days after discharge (Day 15) in Part B|Safety Population||Participants|||Count of Participants
850699|NCT01128621|Primary|Number of Participants With Abnormal Clinical Chemistry Values of PCI (Part A)|"Blood samples for chemistry assessments were collected at screening, fasting (Day -1), at 24hr post- dose (morning of Day 2), and at follow-up.
Clinical chemistry parameter: Glucose (unit: millimoles per liter [mmol/L]) was assessed for abnormal high value of PCI. The normal range was 3.6 to 5.5 mmol/L"|Up to 10 days after discharge (Day 2) in Part A|Safety Population||Participants|||Count of Participants
850715|NCT01029691|Secondary|NICU Admission|Number of mothers who had one (or more) babies admitted to NICU|at delivery (within 6 months of enrollment)|||Participants|||Count of Participants
850716|NCT01029691|Secondary|Birth Weight||At delivery (within 6 months of enrollment)|There is one extra baby in each arm to represent the twins born in each group.||grams|babies|Standard Deviation|Mean
850700|NCT01128621|Primary|Number of Participants With Abnormal Hematology Values of PCI (Part B)|Blood samples for hematology assessments were collected at screening, on Day -2 (non-fasting), and prior to breakfast (early in the morning, fasting) on Days 1, 7, and on Day 15 prior to checkout, (=24hrs post-dose), and at follow-up. Hematology parameters: Hematocrit (unit: ratio) and hemoglobin (unit: grams per liter [g/L]), were assessed for abnormal values of PCI. The PCI range for hematocrit was: >0.075 decrease from Baseline (low), >1.02 x upper limit normal (ULN) (high-male), >1.17 x ULN (high-female). The PCI range for hemoglobin was: >25 decrease from Baseline (low), >1.03 x ULN (high-male), >1.13 x ULN (high-female). Data has been presented for the number of participants with hematology data values high from the PCI range in a consolidated format.|Up to 10 days after discharge (Day 15) in Part B|Safety Population||Participants|||Count of Participants
850701|NCT01128621|Primary|Number of Participants With Abnormal Hematology Values of Potential Clinical Importance (PCI) (Part A)|Blood samples for hematology assessments were collected at screening, fasting (Day -1), at 24hr post- dose (morning of Day 2), and at follow-up. Hematology parameter: Total Neutrophil count was assessed for abnormal value of PCI. The range of PCI value was: <0.83 x lower limit normal (LLN) with unit x10^9 per liter|Up to 10 days after discharge (Day 2) in Part A|Safety Population||Participants|||Count of Participants
850702|NCT01128621|Primary|Number of Participants With Any AEs and Serious Adverse Events SAEs (Part B)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury.|Up to 10 days after discharge (Day 15) in Part B|Safety Population||Participants|||Count of Participants
850703|NCT01128621|Primary|Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) (Part A)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury.|Up to 10 days after discharge (Day 2) in Part A|Safety Population consisted of all participants enrolled in the study and who had received at least one dose of study drug.||Participants|||Count of Participants
850717|NCT01029691|Secondary|Gestational Age at Delivery||At delivery (within 6 months of enrollment).|||weeks||Standard Deviation|Mean
850718|NCT01029691|Primary|Number of Participants With Sleep-disordered Breathing (SDB)|Presence or absence of SDB (defined as an apnea/hypopnea index; AHI>=5)|Baseline night 1|This reflects only the n=43 women who underwent baseline sleep study (n=7 of whom did not go on to receive APAP therapy) prior to assignment to PAP therapy. The standard of care group did not have a baseline sleep study and are therefore not represented here. Of these n=43 women, n=36 received PAP therapy (n=20 were adherent and n=16 were not).||Participants|||Count of Participants
850719|NCT01029691|Primary|Severity of Sleep Disordered Breathing|Severity of sleep disordered breathing, using the apnea/hypopnea index (number of respiratory evens per hour of sleep), among participants who have or do not have nocturnal hypertension. Obstructive sleep apnea is typically considered present if the AHI is at least 5.|at baseline|This reflects only the n=43 women who underwent baseline sleep study (n=7 of whom did not go on to receive APAP therapy) prior to assignment to PAP therapy. The standard of care group did not have a baseline sleep study and are therefore not represented here. Of these n=43 women, n=36 received PAP therapy (n=20 were adherent and n=16 were not).||apnea/hypopnea index||Standard Deviation|Mean
850720|NCT01029691|Primary|Number of Participants With Worsening of Hypertension|This outcome measure's purpose was to look at the impact of the APAP on blood pressure. This was done categorically by looking at worsening of hypertension with or without escalation of antihypertensive medications.|1-6 months after enrollment.|One woman in the standard of care group died during pregnancy and is therefore not included in this analysis.||participants|||Number
850721|NCT01029691|Primary|Nocturnal Blood Pressure|measured by a 24 hour cuff, averaged across the night;|baseline and 1 week after PAP treatment.|The standard of care group did not have nocturnal blood pressure monitoring as they were not assigned to use a positive airway pressure device||mmHg||Standard Deviation|Mean
854668|NCT00374140|Secondary|Objective Response Rate|Number of patients for which response to treatment was observed / total number of patients.|From beginning of treatment up to 60 months|Evaluable for response included patient had completed at least one cycle of therapy with everolimus.||percentage of participants||95% Confidence Interval|Number
854669|NCT00374140|Secondary|Progression-free Survival||From entry into trial to up to 60 months|||months||95% Confidence Interval|Median
854670|NCT00374140|Secondary|Overall Survival||From entry in trial to up to 60 months|||months||95% Confidence Interval|Median
854671|NCT00374140|Primary|Determine the Proportion of Previously Treated Small Cell Lung Cancer (SCLC) Patients Whose Disease Has Not Progressed Following 6-weeks (2 Cycles) of Treatment With RAD001.||Two cycles of treatment with RAD001 (~6 weeks)|||percentage of participants||95% Confidence Interval|Number
854688|NCT00056160|Primary|Time to Tumor Progression (TTP)|Time to progression (TTP) was calculated as the time from randomization to the first documentation of progressive disease based on the myeloma response determination criteria developed by Bladé et. al., Br J Haematol 1998; 102:1115-1123.|60 weeks (median Time To Progression of CC-5013/Dex treatment group)|Analysis conducted on the Intent-To-Treat (ITT) Population. The ITT Population was defined as all subjects randomized.||Weeks||95% Confidence Interval|Median
850760|NCT00984165|Primary|Response to Graft Versus Host Disease (GVHD) Treatment|The following criteria is used to determine response to GVHD treatment. Complete response (CR) is complete resolution of all clinical signs and symptoms of acute GVHD. Partial response (PR) is 50% reduction in skin rash, stool volume or frequency, and/or total bilirubin. Failure to maintain adequate performance status (Karnofsky Score >/= 70%). Non-responder (NR) <50% reduction in skin rash, stool volume or frequency, and/or total bilirubin. Failure to maintain adequate performance status (Karnofsky Score </= 70%). Progressive disease (PD) is further progression of signs and symptoms of acute GVHD, and/or decline in performance status after the initiation of therapy.|Up to 100 days|"No results were collected on the Donor Lymphocyte Infusion-Donor Arm. This arm allowed for collection of the lymphocytes on healthy donors for infusion on the DLI/Radiation Arm or the DLI/Control Group."||participants|||Number
850761|NCT00957723|Primary|Implant Survivorship||10 years||||||
850762|NCT00957723|Secondary|Patient Outcome Long Term Follow-up Questionnaire Over Time||6,7,8,9,10 years||||||
850763|NCT00957723|Secondary|Patellar Subluxation, Dislocation and Fracture Rate|The incidence of patellar subluxation, dislocation or fracture is reported.|5 years|Participants with available data.||percentage of knees|knees||Number
850764|NCT00957723|Secondary|Change in Lower-Extremity Activity Scale (LEAS) Over Time|The LEAS is completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level.|preoperative, 1,2,3,4,5 years|Participants with available data: A total of 439 knees had a preoperative LEAS evaluation, 380 had 1 year, 304 had 2 year, 273 had 3 year, 222 had 4 year, and 201 had 5 year LEAS evaluations.||units on a scale|knees|Standard Deviation|Mean
850765|NCT00957723|Secondary|Change in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Over Time|The WOMAC collects information specific to osteoarthritis outcomes. The questionnaire uses a visual analog scale for pain, measuring factors of general pain, stiffness, and physical findings. Pain is scored from 0 to 100 for each set of factors, with 0 indicating no pain and 100 indicating extreme pain. Total WOMAC scores range from 0 to 300. Lower values represent better outcomes.|preoperative,1,2,3,4 and 5 years|Participants with available data: Data for the WOMAC is only available at the 2,3,4 and 5 year intervals in limited numbers due to typographical errors noted on earlier interval forms rendering them invalid for comparison. One knee completed the validated WOMAC at 2 & 3 years, 51 at 4 years and 97 at 5 years.||units on a scale|knees|Standard Deviation|Mean
850766|NCT00957723|Secondary|Change in SF-36 Health Survey Over Time|The SF-36 Health Survey is a 36 item patient completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.|preoperative, 1,2,3,4,5 years|Participants with available data: A total of 433 knees completed a preoperative SF-36 evaluation, 379 completed a 1 year, 303 completed a 2 year, 270 completed a 3 year, 223 completed a 4 year, and 195 completed a 5 year SF-36 evaluation.||units on a scale|knees|Standard Deviation|Mean
850767|NCT00957723|Secondary|Number of Knees With Radiographic Failure Assessed Via the Knee Society Total Knee Arthroplasty Roentgenographic Score|Parameters for radiographic failures will follow the guidelines that have been set by the Knee Society. The scoring system for each of the three components is determined by measuring the width of the radiolucent lines for each of the zones in millimeters for each of the three components. The total widths in millimeters are added for each zone for each of the three prostheses. The total produces a numerical score for each component. Failure is defined as a score of 10 or greater, regardless of symptoms.|1,2,5 years|Participants with available data: A total of 371 knees were assessed radiographically at 1 year, 313 at 2 years, and 199 at 5 years.||Total number of knees|knees||Number
850768|NCT00957723|Secondary|Active Flexion, Passive Flexion, Active Extension, and Passive Extension Range of Motion (ROM)|Knee range of motion is measured by the number of degrees flexion and extension observed. Active motion is the number of degrees that a participant can extend and flex their knee independently. Passive motion is the number of degrees that an examiner is able to extend and flex the knee without the assistance of the participant. The Knee Society Score range of motion utilized for this study defines the range from 0 degrees of extension to 125 degrees of flexion.|1,2,5 years|Participants with available data: A total of 386 knees had 1 year active flexion/extension measurements, 317 had 2 year, and 201 had 5 year active flexion/extension measurements.A total of 385 knees had 1 year passive flexion/extension measurements, 312 had 2 year, and 197 had 5 year passive flexion/extension measurements.||degrees|knees|Standard Deviation|Mean
850769|NCT00957723|Secondary|Change in Knee Society Score (KSS) Over Time|The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, ROM and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as “excellent,” “good,” “fair,” or “poor,” a higher value represents a better outcome.|preoperative, 1, 2, 5 years|Participants with available data: For the pain/motion sub-score 415 knees had a preoperative evaluation, 364 had a 1 year, 298 had a 2 year and 190 had a 5 year evaluation. For the function sub-score 440 knees had a preoperative evaluation, 385 had a 1 year, 309 had a 2 year and 203 had a 5 year evaluation.||units on a scale|knees|Standard Deviation|Mean
850770|NCT00957723|Primary|Active Range of Motion||2 Years|Per protocol||Degrees|Knee Implants|Standard Deviation|Mean
850771|NCT00943722|Secondary|Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (Lot Consistency Study)|Serum antibody titers for HPV virus-like particles (VLPs), Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post- vaccination 3 using cLIA. The serostatus cutoffs (milli Merck U/mL) for HPV types were as follows: HPV Type 6: ≥30, HPV Type 11: ≥16; HPV Type 16: ≥20, HPV Type 18: ≥24, HPV Type 31: ≥10, HPV Type 33: ≥8, HPV Type 45: ≥8, HPV Type 52: ≥8, and HPV Type 58: ≥8.|4 weeks post-vaccination 3 (Month 7)|9- to 15-year-old females who received 3 vaccinations from Lots 1, 2, and 3 and met following criteria for at least 1 of the 9 HPV types: no general protocol violations, received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), and had a Month 7 serum sample collected within an acceptable day range||Percentage of Participants||95% Confidence Interval|Number
850772|NCT00943722|Secondary|Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Males [Lot 1] Versus 16- to 26-Year-Old Females [Lot 1])|Serum antibody titers for HPV VLPs, Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using cLIA. The serostatus cutoffs (milli Merck U/mL) for HPV types were as follows: HPV Type 6: ≥30, HPV Type 11: ≥16; HPV Type 16: ≥20, HPV Type 18: ≥24, HPV Type 31: ≥10, HPV Type 33: ≥8, HPV Type 45: ≥8, HPV Type 52: ≥8, and HPV Type 58: ≥8.|4 weeks post-vaccination 3 (Month 7)|9-15-year-old males and 16-26-year-old females who received 3 vaccinations from Lot 1 and met following criteria for at least 1 of the 9 HPV types: no general protocol violations, received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), and had a Month 7 serum sample collected within an acceptable day range||Percentage of Participants||95% Confidence Interval|Number
850773|NCT00943722|Secondary|Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Females [Lot 1] Versus 16- to 26-Year-Old Females [Lot 1])|Serum antibody titers for HPV virus-like particles (VLPs), Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using cLIA. The serostatus cutoffs (milli Merck U/mL) for HPV types were as follows: HPV Type 6: ≥30, HPV Type 11: ≥16; HPV Type 16: ≥20, HPV Type 18: ≥24, HPV Type 31: ≥10, HPV Type 33: ≥8, HPV Type 45: ≥8, HPV Type 52: ≥8, and HPV Type 58: ≥8.|4 weeks post-vaccination 3 (Month 7)|9-15-year-old females and 16-26-year-old females who received 3 vaccinations from Lot 1 and met following criteria for at least 1 of the 9 HPV types: no general protocol violations, received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), and had a Month 7 serum sample collected within an acceptable day range||Percentage of Participants||95% Confidence Interval|Number
850774|NCT00943722|Primary|Percentage of Participants With Body Temperature ≥100.0°F (≥37.8ºC)|Participants collected their oral body temperature in the evening of their vaccination day and at the same time each day thereafter for 4 days. The maximum body temperature obtained within 5 days of any of the 3 vaccinations was recorded. The percentage of participants who had at least 1 oral body temperature reading that was ≥100.0°F (≥37.8ºC) was summarized.|up to 5 days after any vaccination|All participants who received at least one dose of 9vHPV vaccine and had available follow-up data. Data from 9- to 15-year-old females were pooled regardless of lot administered.||Percentage of Participants|||Number
850775|NCT00943722|Primary|Percentage of Participants With Systemic AEs|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Systemic AEs were those not categorized as injection-site AEs.|up to 15 days after any vaccination|All participants who received at least one dose of 9vHPV vaccine and had available follow-up data. Data from 9- to 15-year-old females were pooled regardless of lot administered.||Percentage of Participants|||Number
850776|NCT00943722|Primary|Percentage of Participants With Injection Site Adverse Experiences (AEs)|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. AEs such as redness, swelling, and pain/tenderness/soreness at the injection site were recorded.|up to 5 days after any vaccination|All participants who received at least one dose of 9vHPV vaccine and had available follow-up data. Data from 9- to 15-year-old females were pooled regardless of lot administered.||Percentage of Participants|||Number
850777|NCT00943722|Primary|GMTs for Each of the HPV Types Contained in the Vaccine (Lot Consistency Study)|Serum antibody titers for HPV VLPs, Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using cLIA. Titers are reported in milli Merck Units/mL.|4 weeks post-vaccination 3 (Month 7)|9- to 15-year-old females who received 3 vaccinations from Lots 1, 2, and 3 and met following criteria for at least 1 of the 9 HPV types: no general protocol violations, received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), and had a Month 7 serum sample collected within an acceptable day range||milli Merck Units/mL||95% Confidence Interval|Geometric Mean
850778|NCT00943722|Primary|GMTs for Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Males [Lot 1] Versus 16- to 26-Year-Old Females [Lot 1])|Serum antibody titers for HPV VLPs, Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using a competitive luminex immunoassay (cLIA). Titers are reported in milli Merck Units/mL.|4 weeks post-vaccination 3 (Month 7)|9-15-year-old males and 16-26-year-old females who received 3 vaccinations from Lot 1 and met following criteria for at least 1 of the 9 HPV types: no general protocol violations, received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), and had a Month 7 serum sample collected within an acceptable day range||milli Merck Units/mL||95% Confidence Interval|Geometric Mean
850779|NCT00943722|Primary|Geometric Mean Titers (GMTs) for Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Females [Lot 1] Versus 16- to 26-Year-Old Females [Lot 1])|Serum antibody titers for HPV virus-like particles (VLPs), Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using a competitive luminex immunoassay (cLIA). Titers are reported in milli Merck Units/mL.|4 weeks post-vaccination 3 (Month 7)|9-15-year-old females and 16-26-year-old females who received 3 vaccinations from Lot 1 and met following criteria for at least 1 of the 9 HPV types: no general protocol violations, received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), and had a Month 7 serum sample collected within an acceptable day range||milli Merck Units/mL||95% Confidence Interval|Geometric Mean
850780|NCT00887458|Secondary|To Determine the Proportion of Men With ≥ 50% PSA Reduction From Baseline.|Will be reported as the percentage of men with ≥ 50% PSA reduction from baseline.|Baseline and approximately 2 years from open enrollment|One subject in the high dose arm was not evaluable on account of subject discontinuing study drug during cycle 1 due to clinical progression.||percentage||95% Confidence Interval|Number
850781|NCT00887458|Primary|To Determine the Proportion of Patients With Metastatic CRPC Who do Not Have Prostate Specific Antigen (PSA) Progression After 24 Weeks of Therapy With One of Two Dose-levels of Itraconazole: 200 mg or 600 mg Daily.|"To Determine the Proportion of Patients With Metastatic CRPC Who do Not Have Prostate Specific Antigen (PSA) Progression After 24 Weeks of Therapy. PSA progression is defined as a 25% increase in PSA over baseline [or nadir (lowest)] and an increase in absolute PSA level by at least 2 ng/mL, both confirmed by a second value at least 4 weeks later."|Up to 24 weeks|Based on how many participants were evaluable for the study primary endpoint||percent of patients||95% Confidence Interval|Number
850849|NCT00846651|Secondary|Incidence of Maternal Nausea and Vomiting||participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby|||percentage of participants|||Number
850850|NCT00846651|Secondary|APGAR Scores|The Apgar score is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10 with higher scores being better than lower scores. The five criteria are summarized using words chosen to form an acronym (Appearance, Pulse, Grimace, Activity, Respiration).|Apgar scores were assessed at 1 amd 5 min after delivery of the baby|||units on a scale||Full Range|Median
850851|NCT00846651|Secondary|Fetal Cord Blood pH||delivery of the baby|Physician policy changes resulted in blood gas values not being ordered and thus data was not available for the outcome measure.|||||
850852|NCT00846651|Secondary|Incidence of Maternal Bradycardia||participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby|||percentage of participants|||Number
850853|NCT00846651|Secondary|Dosage of Phenylephrine Used||participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby|||mcg of phenylephrine||Standard Deviation|Mean
850854|NCT00846651|Primary|Incidence of Maternal Hypotension||participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby|||percentage of participants|||Number
850855|NCT00833989|Secondary|Serum Levels of the S100β Protein|The serum sample for S100β collected on Day 1 (predose, 1, 6, 12 and 24 hour) and Day 5 and was analyzed for levels. Serum levels of S100β protein were recorded as log transformed values therefore the negative values are reported.|Day 1 (Pre-dose, Post dose 1, 6, 24 hour), Day 5|All Subjects population. Only those participants with data available at the indicated time points were analyzed.||ug per litre||Standard Deviation|Mean
850856|NCT00833989|Secondary|Mean Change in Transcranial Magnetic Stimulations (TMS) Evaluated by Peak to Peak MEP by % Stimulation Level|TMS is an electrophysiological technique that was used to measure neurologic changes associated with recovery from stroke via alterations in the excitability of the motor system. Motor threshold measures reflect global excitability of the corticospinal pathway, including large pyramidal cells, excitatory/inhibitory interneurons, and spinal motorneurons. Motor threshold was recorded as the lowest stimulus intensity (in percent) eliciting motor evoked potentials (MEPs). Baseline assessments were recorded at Day 1 of the study. The change from Baseline was calculated by subtracting the Baseline values from the individual post -randomization values. If either the Baseline or post-randomization value was missing, the change from Baseline was set to missing as well.|Baseline (Day 1), Day 30 and 112|All subjects population. Only those participants with data available at the indicated time points were analyzed.||Percent change in stimulation||Standard Deviation|Mean
850857|NCT00833989|Secondary|Mean Geriatric Depression Scale (GDS)|The short form GDS is a measure of depression developed specifically for use in elderly population and is sensitive and valid in the stroke population. The GDS was a participant-completed, 15 item questionnaire where each question referenced how the participant felt over the past week. Each question was answered with either a ‘yes’ or ‘no’ response. Of the 15 questions, 10 of them indicate depression when answered ‘yes’ (questions 2-4, 6, 8-10, 12, 14-15) and 5 indicate depression when answered ‘no’ (questions 1, 5, 7, 11, 13). Each question received a score of 1 point when the response was indicative of depression. Total score ranged from 0 to 15. the total score ranged from 0-15, where 0 implies no symptoms and higher score implies more severity of symptoms.|Day 5 and 90|All Subjects population. Only those participants with data available at the indicated time points were analyzed.||Score on scale||Standard Deviation|Mean
850874|NCT00833989|Primary|Number of Participants With Abnormal Hematological Parameters|The clinical chemistry parameters analyzed were white blood cell count, neutrophil count, hemoglobin, platelet count, lymphocytes. Only those parameters for which at least one abnormal value was reported are summarized. The number of participants with abnormal hematology findings at specified visit were reported.|Up to Day 112|All Subjects population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.||Participants|||Count of Participants
850858|NCT00833989|Secondary|Mean Total Montreal Cognitive Assessment (MoCA) Score|MoCA was an examiner-administered, screening instrument with good validity, reliability, sensitivity and specificity for mild cognitive dysfunction. The MoCA had been studied in stroke participants and was recommended as a tool to monitor and measure cognitive changes post stroke as part of the 2006 National Institute of Neurological Disorders and Stroke – Canadian Stroke Network Vascular Cognitive Impairment Harmonization Standards. The MoCA assesses eight cognitive domains of visuospatial skills, executive function, language, attention, concentration, working memory, memory, and orientation. Participants were asked to complete 14 activities which the examiner scored according to the standardized scoring instructions. While there was no set time limit imposed on a participant. The total MoCA score ranges from 0-30, where 0= worsening and 30 reflects normal cognitive function.|Day 5 and 90|All Subjects population. Only those participants with data available at the indicated time points were analyzed.||Score on scale||Standard Deviation|Mean
850859|NCT00833989|Secondary|Mean Barthel Total Score|The Barthel was a staff-assessed, 10 item activities of daily living index that evaluated feeding, grooming, dressing, excretion (bowels, bladder and toilet skills), bathing, and mobility (transfers, walking, stairs). The total Barthel score ranged from either 0-20 or 0-100 depending on which scoring algorithm was used where 0= unable or dependent and 20 or 100= independent to perform daily activities. For this study, the 100 point scoring algorithm was used. The Barthel takes approximately 5-10 minutes to complete with the participant.|Day 30 and 90|All subjects population. Only those participants with data available at the indicated time points were analyzed.||Score on scale||Standard Deviation|Mean
850860|NCT00833989|Secondary|Change From Baseline of National Institutes of Health Stroke Scale (NIHSS)|The NIHSS is a staff-assessed, 15 item, standardized, disease-specific, deficit scale which measures neurological impairment and is used to quantify participant status by measuring the severity of the stroke. The total NIHSS score ranged from 0 (No impairment) to 42 (severe impairment). Approximately 15 minutes were needed to complete the NIHSS. The NIHSS will be collected as part of the eligibility requirements to exclude participants who have a deficit that is either too mild or too severe. Only NIHSS certified study personnel recorded the NIHSS. Baseline assessments were recorded at Day 1 of the study. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value was missing, the change from Baseline was set to missing as well.|Baseline (Day 1), Day 10, 30 and 90|All Subjects population. Only those participants with data available at the indicated time points were analyzed.||Score on scale||Standard Deviation|Mean
850861|NCT00833989|Secondary|Number of Participants With Modified Rankin Scale (mRS)|The mRS was a 6 point scale that measured participant handicap by evaluating limitations in activity and changes in lifestyle. The mRS was staff-assessed and scored from 0=no symptoms at all, 1=no significant disability, 2=slight disability, 3=moderate disability, 4=moderate severe disability, 5=severe disability (severe disability, bedridden, incontinent and requiring constant nursing care and attention). The structured interview was used to administer the mRS. The mRS took approximately 15 minutes to complete when using the structured interview. Number of participants with mRS were reported as per the category of the score.|Day 30 and 90|All subjects population. Only those participants with data available at the indicated time points were analyzed.||Participants|||Count of Participants
850862|NCT00833989|Secondary|Mean Change in Grip Strength on Affected Side|Grip strength is an objective measure of arm motor recovery in stroke participants and correlate with functional status and predict recovery. Grip strength was evaluated by a hand grip dynamometer. Three replicate trials was collected for both the impaired and normal hand, starting with the normal hand. Each trial was separated by a resting period of approximately 15-30 seconds. Participants was instructed to squeeze as hard as possible while using a standardized position of grip and the resulting dynamometer reading (in kg) was recorded. The grip strength measures was conducted within approximately 5 minutes. Baseline assessments were recorded at Day 1 of the study. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value was missing, the change from Baseline was set to missing as well.|Baseline (Day 1), Day 30, 60, 90 and 112|All Subjects population. Only those participants with data available at the indicated time points were analyzed.||Kg||Standard Deviation|Mean
850863|NCT00833989|Secondary|Mean Change in Total Box and Blocks Transferred on Affected Side|The Box and Blocks test is an objective, gross manual dexterity test that is reliable and valid in individuals with upper limb impairments. Box and Blocks was a staff-assessed, participant completed test that required the participant to move small wooden blocks from one side of a partitioned box to the other. The score was determined by the number of blocks transferred within a 60 second time period. More number of blocks transferred as compared to Baseline indicated improvement. Both the impaired and normal limbs were tested, starting with the normal limb. The number of blocks transferred were recorded. Baseline assessments were recorded at Day 1 of the study. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value was missing, the change from Baseline was set to missing as well.|Baseline (Day 1), Day 30, 60, 90 and 112|All subjects population. Only those participants with data available at the indicated time points were analyzed.||Blocks||Standard Deviation|Mean
850864|NCT00833989|Secondary|Mean Change in Total Fugl-Meyer Motor (FM) Assessment|The FM assessment is a staff-assessed, disease specific, quantitative measure of impairment that is used to assess recovery of sensorimotor function post stroke. The FM is designed to assess the domains of motor function, balance, sensation and joint function. For this study, only the motor function domain was assessed. The motor domain scale takes approximately 30 minutes to complete and evaluates both the upper and lower extremities by direct observation of the participant’s performance of 50 items that measure movement, coordination, and reflex action. Each item was scored from 0-2 for a minimum total score of 0 (hemiplegia) and a maximum total score of 100 (normal motor performance). Baseline assessments were recorded at Day 5 of the study. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value was missing, the change from Baseline was set to missing as well.|Baseline (Day 5), Day 30 and 112|All subjects population. Only those participants with data available at the indicated time points were analyzed.||Score on Scale||Standard Deviation|Mean
850865|NCT00833989|Secondary|Mean Change in Berg Balance Scale (BBS) Total Score|BBS is a performance based measure of balance. It is reliable, valid and responsive to change in the stroke population. BBS is a staff-assessed measure that requires the participant to perform 14 activities that evaluate ability to maintain balance. The BBS typically takes 10-15minute to complete. Participants were not allowed to use assistive devices while performing the activities. Each activity was evaluated by direct observation of the participant’s performance and was scored on a 5-point ordinal scale (0-4) where a score of 0 represents inability to perform the activity and a score of 4 represents independence in the activity. The minimum total score on the BBS was 0 and maximum was 56. Baseline assessments were recorded at Day 5 of the study. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value was missing, the change from Baseline was set to missing as well.|Baseline (Day 5), Day 30, 60, 90 and 112|All Subjects population. Only those participants with data available at the indicated time points were analyzed.||Score on Scale||Standard Deviation|Mean
850866|NCT00833989|Secondary|Mean Change in Mean Gait Velocity|Gait velocity is an objective, quantitative, reliable, valid and sensitive measure of lower extremity motor recovery in the stroke population. Changes in gait velocity correlates with physical functioning and quality of life. Gait velocity was assessed over a level, indoor 10 meter distance. The time (in seconds) it takes the participant to travel the 10 meter distance was recorded. Participants was asked to walk at their usual or normal pace and may use their normal assistive devices. Baseline assessments were recorded at Day 5 of the study. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value was missing, the change from Baseline was set to missing as well.|Baseline (Day 5), Day 30, 60, 90, 112|All Subjects population. Only those participants with data available at the indicated time points were analyzed.||Meters/second||Standard Deviation|Mean
850867|NCT00833989|Secondary|Mean Clearance of GSK249320|The pharmacokinetic parameters were calculated by standard non-compartmental analysis using Win Nonlin Pro 4.1. All calculations of non-compartmental parameters were based on actual sampling times. The clearance was calculated as Dose/ AUC(0-inf).|Day 1 (Pre-dose, 1, 3, 6, 12 and 24 hour) and Day 10 (Pre-dose, 1, 3 hour)|Pharmacokinetics population. Only those participants with data available for analysis were analyzed.||mL/hour/killogram (kg)||Standard Deviation|Mean
850868|NCT00833989|Secondary|Mean Terminal Phase Rate Constant ( Lambda-Z)|The pharmacokinetic parameters were calculated by standard non-compartmental analysis using Win Nonlin Pro 4.1. All calculations of non-compartmental parameters were based on actual sampling times. Lambda-Z is the terminal phase rate constant estimated by linear regression analysis of the log transformed concentration-time data.|Day 1 (Pre-dose, 1, 3, 6, 12 and 24 hour) and Day 10 (Pre-dose, 1, 3 hour)|Pharmacokinetics population. Only those participants with data available for analysis were analyzed.||1/ hour||Standard Deviation|Mean
850869|NCT00833989|Secondary|Mean Terminal Phase Half-life (t1/2)|The pharmacokinetic parameters were calculated by standard non-compartmental analysis using Win Nonlin Pro 4.1. All calculations of non-compartmental parameters were based on actual sampling times. The apparent t1/2 obtained as the ratio of natural log (ln)^2/ lambda-Z, where lambda-Z is the terminal phase rate constant estimated by linear regression analysis of the log transformed concentration-time data.|Day 1 (Pre-dose, 1, 3, 6, 12 and 24 hour) and Day 10 (Pre-dose, 1, 3 hour)|Pharmacokinetics population. Only those participants with data available for analysis were analyzed.||Day||Standard Deviation|Mean
850870|NCT00833989|Secondary|Mean Time of Occurrence of Cmax (Tmax) and Time of Last Observed Quantifiable Concentration (Tlast)|The pharmacokinetic parameters were calculated by standard non-compartmental analysis using Win Nonlin Pro 4.1. All calculations of non-compartmental parameters were based on actual sampling times. Tmax and tlast were determined directly from the raw concentration-time data.|Day 1 (Pre-dose, 1, 3, 6, 12 and 24 hour) and Day 10 (Pre-dose, 1, 3 hour)|Pharmacokinetics population. Only those participants with data available for analysis were analyzed.||hour||Standard Deviation|Mean
850871|NCT00833989|Secondary|Mean Maximum Observed Concentration (Cmax) and Last Observed Quantifiable Concentration (Ct)|The pharmacokinetic parameters were calculated by standard non- compartmental analysis using Win Nonlin Pro 4.1. All calculations of non-compartmental parameters were based on actual sampling times. Cmax and Ct were determined directly from the raw concentration-time data.|Day 1 (Pre-dose, 1, 3, 6, 12 and 24 hour) and Day 10 (Pre-dose, 1, 3 hour)|Pharmacokinetic population. Only those participants with data available for analysis were analyzed.||microgram (ug) per mL||Standard Deviation|Mean
850872|NCT00833989|Secondary|Mean Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC 0-inf) and Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC0-t)|The pharmacokinetic parameters were calculated by standard non-compartmental analysis using Win Nonlin Pro 4.1. All calculations of non-compartmental parameters were based on actual sampling times. AUC0-t was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. AUC(0-inf) were calculated, where data permit, as the sum of area under the concentration-time curve over the dosing interval from 0 to Day 10 ±1 day (AUC0-10d) and C10d/z, where C10d is the observed plasma concentration at day 10 and z is the terminal phase rate constant calculated after the second dose.|Day 1 (Pre-dose, 1, 3, 6, 12 and 24 hour) and Day 10 (Pre-dose, 1, 3 hour)|Pharmacokinetic population comprised of participants from the ‘All Subjects’ population for whom a pharmacokinetic sample was obtained and analyzed. Only those participants with data available for analysis were analyzed.||Hour*mg/millilitre (mL)||Standard Deviation|Mean
850873|NCT00833989|Secondary|Number of Participants With Positive Antibodies to GSK249320|Presence of antibodies to GSK249320 were assessed in serum samples of participants using immunoelectro-chemiluminescent assay. Number of participants with positive antibodies to GSK249320 were reported. Only visits where the true positive antibody detection was observed were reported.|Day 1, 5, 10, 30, 60, 90 and 112|All Subjects population. Only those participants with data available at the indicated time points were analyzed.||Participants|||Count of Participants
850875|NCT00833989|Primary|Number of Participants With Abnormal Clinical Chemistry Parameters|The clinical chemistry parameters analyzed were albumin, calcium, creatinine, glucose, potassium, sodium, total CO2, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, and total bilirubin. Only those parameters for which at least one abnormal value was reported are summarized. The number of participants with abnormal clinical chemistry findings at specified visit were reported.|Up to Day 112|All Subjects population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.||Participants|||Count of Participants
850876|NCT00833989|Primary|Number of Participants With White Matter Changes and Demyelination Assessed by Magnetic Resonance Imaging (MRI)|Whole brain MRI scans were performed by appropriately qualified personnel at those specified visits (Day 1, 10 and 60 or at early withdrawal [if participant withdrew from study before Day 60 MRI]). Required pulse sequences of diffusion weighted imaging (DWI), T1, and T2 FLAIR was performed to measure lesion volume and to look for the presence of any new acute inflammatory lesions. The investigator or other medically qualified study team member evaluated the Day 10 and 60 scans for any new abnormalities or clinically significant worsening. Digital data for each MRI was sent to a central MRI laboratory for an over-read of the MRI scan and calculation of the lesion volume. Number of participants with change in white matter and demyelination on Day 10 compared to Day 1, Day 60 compared to Day 1 and Day 60 compared to Day 10 were reported.|Up to Day 60|All Subjects population. Only those participants with data available at the indicated time points were analyzed.||Participants|||Count of Participants
850877|NCT00833989|Primary|Number of Participants With Nerve Conduction Testing (NCT) Values|NCT (electrode placement technique) of sensory and motor function was performed on the unaffected side (i.e., side that is not affected by the stroke) by appropriately qualified personnel at specified visits (Day 5 and 30 and at early withdrawal). Qualified technician performed the testing; however the same neurologist interpreted the NCT data within a single participant. Both upper and lower extremity nerves were tested and the data was recorded. Number of participants with normal and abnormal NCT data were reported.|Day 5 and 30 and at early withdrawal|All Subject population. Only those participants with data available at the indicated time points were analyzed.||Participants|||Count of Participants
850878|NCT00833989|Primary|Number of Participants With Electrocardiogram (ECG) Values Outside Range of Potential Clinical Importance|Single 12-lead ECGs was obtained. The standard ECG criteria of potential clinical importance were uncorrected QT interval <300 and >600 milliseconds (msec), absolute QTc interval >500 msec, increase from Baseline QTc >60 msec, RR Interval <90 and >2000 msec, PR Interval <110 and >220 msec, QRS Interval <75 and >110 msec. The number of participants with potentially clinically significant ECG abnormality were reported.|Up to 112 days|All Subjects population. Only those participants with data available at the indicated time points were analyzed.||Participants|||Count of Participants
850879|NCT00833989|Primary|Number of Participants With Vital Signs Changes of Potential Clinical Importance|The potential clinical importance ranges (low and high) of the vital sign parameters were for systolic blood pressure (SBP) (<85 and >200 millimeter of mercury [mmHg]), diastolic blood pressure (DBP) (<45 and >110 mmHg) and heart rate (HR) (<40 and >110 beats per minute). Only those parameters for which at least one value of potential clinical importance was reported are summarized. The number of participants with potential clinical important vital parameter findings at any visit were reported.|Up to 112 days|All Subjects population. Only those participants with data available at the indicated time points were analyzed.||Participants|||Count of Participants
850880|NCT00833989|Primary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|AE was defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE include AEs those result in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.|Up to 112 days|All Subjects population was defined as all participants who receive at least one dose of study medication.||Participants|||Count of Participants
850932|NCT00692770|Secondary|Time to Recurrence (TTR) by Independent Assessment|"TTR was defined as the time from randomization to the first documented disease recurrence by independent radiological assessment. For subjects who had not recurred at the time of analysis, TTR was censored at their last date of evaluable scan before withdrawal for any other reason than recurrence. NA in the reported data indicates values could not be estimated due to censored data."|From randomization up to 4 years or until disease recurrence whichever came first|FAS included participants who were randomized to study treatments.||Days||95% Confidence Interval|Median
850893|NCT00739752|Primary|Number of Participants Administered Hepatitis B Vaccine|Number of participants administered hepatitis B vaccine on the day of research visit.|Day of research visit|||Participants|||Count of Participants
850894|NCT00725764|Secondary|Apparent Volume of Distribution|Blood samples were planned to be obtained during indicated time points: Day 1, 5, 19, 33, 43, 47 (approximately 15 minutes before dosing, and at 4 hours (±30 minutes) after dosing). Data for apparent volume of distribution was not derived as pharmacokinetic analysis was not completed. Data was not collected for PK analysis.|Day 1, 5, 19, 33, 43, 47 (pre-dose15 min) and 4 h (± 30 min) post-dose|Safety population. Data was not collected for this endpoint.|||||
850895|NCT00725764|Secondary|Apparent Oral Clearance|Blood samples were planned to be obtained during indicated time points: Day 1, 5, 19, 33, 43, 47 (approximately 15 minutes before dosing, and at 4 hours (±30 minutes) after dosing). Data for apparent oral clearance was not derived as pharmacokinetic analysis was not completed. Data was not collected for this endpoint.|Day 1, 5, 19, 33, 43, 47 (pre-dose15 min) and 4 h (± 30 min) post-dose|Safety population. Data was not collected for this endpoint.|||||
850896|NCT00725764|Secondary|Elimination Half-life (t1/2) of Foretinib in Participants With SCCHN|t1/2 was defined as the time to when half of the total amount of a particular substance is eliminated from the body. Blood samples were planned to be obtained during indicated time points: Day 1, 5, 19, 33, 43, 47 (approximately 15 minutes before dosing, and at 4 hours (±30 minutes) after dosing). However these analyses were not completed. Data was not collected for this endpoint.|Day 1, 5, 19, 33, 43, 47 (pre-dose15 min) and 4 h (± 30 min) post-dose|Safety population. Data was not collected for this endpoint.|||||
850897|NCT00725764|Secondary|Area Under the Concentration-time Curve (AUC) of Foretinib in Participants With SCCHN|AUC was defined as area under the plasma concentration vs. time curve. Blood samples were planned to be collected on time points: Day 1, 5, 19, 33, 43, 47 (approximately 15 minutes before dosing, and at 4 hours (±30 minutes) after dosing). However these analyses were not completed. Data was not collected for this endpoint.|Day 1, 5, 19, 33, 43, 47 (pre-dose15 min) and 4 h (± 30 min) post-dose|Safety population. Data was not collected for this endpoint.|||||
850898|NCT00725764|Secondary|Time to Maximum Plasma Concentration (Tmax) of Foretinib in Participants With SCCHN|tmax was defined as the time to the maximum or “peak” concentration of a drug observed after multiple administration. Blood samples were planned to be obtained during the time points: Day 1, 5, 19, 33, 43, 47 (approximately 15 minutes before dosing, and at 4 hours (±30 minutes) after dosing). However these analyses were not completed. Data was not collected for this endpoint.|Day 1, 5, 19, 33, 43, 47 (pre-dose15 min) and 4 h (± 30 min) post-dose|Safety population. Data was not collected for this endpoint.|||||
850899|NCT00725764|Secondary|Maximum Plasma Concentration (Cmax) of Foretinib in Participants With Squamous Cell Carcinoma of the Head and Neck (SCCHN)|Plasma samples for pharmacokinetic analysis were planned to be drawn at time points: Day 1, 5, 19, 33, 43, 47 (approximately 15 minutes before dosing, and at 4 hours (±30 minutes) after dosing) of each treatment cycle, however these analyses were not completed. Cmax was defined as maximal measured plasma concentration over the time span specified. Data was not collected for this endpoint.|Day 1, 5, 19, 33, 43, 47 (pre-dose15 min) and 4 h (± 30 min) post-dose|Safety population. Data was not collected for this endpoint.|||||
850900|NCT00725764|Secondary|Percentage Participants With Disease Stabilization Rate|Disease stabilization rate was defined as the proportion of participants for whom the best overall response was a PR, CR, or stable disease. percentage participants with disease stabilization rate were presented.|Approximately up to 1 year|Safety Population||percentage of participants||95% Confidence Interval|Number
856953|NCT02542072|Secondary|Lens Centration|Lens centration will be recorded by degree and direction in the primary position. 0=Centered -optimal, 1=Decentered slightly, 2=Substantially decentered (>0.5mm)|Baseline, 2 weeks, 4 weeks|||Eyes|Eyes||Number
856954|NCT02542072|Secondary|Visual Acuity (VA)|Visual acuity (VA) for comfilcon A and samfilcon A lens wear is assessed using Snellen.|Baseline, 2 weeks, 4 weeks|||LogMAR||Standard Deviation|Mean
856955|NCT02542072|Secondary|White Spot Deposits|Number of white spot deposits for comfilcon A and samfilcon A lenses.|2 weeks and 4 weeks|||number of white spots|Eyes|Standard Deviation|Mean
856956|NCT02542072|Secondary|Film Deposits|Front surface film deposits for comfilcon A and samfilcon A lenses. Scale 0-4, 0=No film, 1=Slight film visible only under magnification, 2=Moderate film only under magnification, 3=Moderate film visible to the naked eye, 4=Heavy film visible to the naked eye.|2 weeks and 4 weeks|||units on a scale|Eyes|Standard Deviation|Mean
856957|NCT02542072|Secondary|Lens Surface Wetting|Lens surface wettability assessment for comfilcon A and samfilcon A lenses. Scale 0-4 in 0.5 steps, 0=very poor, 4=excellent|Baseline, 2 weeks, 4 weeks|||units on a scale|Eyes|Standard Deviation|Mean
856958|NCT02542072|Secondary|Biomicroscopy Scores|Biomicroscopy for comfilcon A and samfilcon A lens assessed. Scale 0-4 in 0.5 steps 0=none, 1=trace, 2=mild, 3=moderate, 4=severe|Baseline, 2 weeks, 4 weeks|||units on a scale|Eyes|Standard Deviation|Mean
856959|NCT02542072|Secondary|Overall Lens Handling|Handling (ease of insertion and ease of removal) for comfilcon A and samfilcon A lenses. Scale 0-10, 0=very difficult to handle, 10=very easy to handle.|Baseline, 2 weeks, 4 weeks|||units on a scale||Standard Deviation|Mean
856960|NCT02542072|Secondary|Vision Quality|Vision quality of comfilcon A and samfilcon A lenses. Scale 0-10, 0=completely dissatisfied, 10=completely satisfied.|Baseline, 2 weeks, 4 weeks|Number of participants analyzed differ from participant flow due to protocol deviations.||units on a scale||Standard Deviation|Mean
856961|NCT02542072|Secondary|Deterioration in Comfort|Deterioration of comfortable wearing time for habitual, comfilcon A, samfilcon A lenses. Subjects answered 'yes' or 'no' to the following question 'does contact lens comfort deteriorate during wear?'. Yes=deterioration in comfort present, No=deterioration in comfort absent|Baseline, 2 weeks, 4 weeks|||participants|||Number
856962|NCT02542072|Secondary|Wearing Times|Average wear time and comfortable wearing times (WTs) in hours for habitual, comfilcon A, and samfilcon A lenses.|Baseline, 2 weeks, 4 weeks|||hours||Standard Deviation|Mean
856963|NCT02542072|Secondary|Comfortable Wearing Time Via SMS (Short Message Service)|Comfortable wearing times (WTs) via SMS (Short Message Service) for comfilcon A and samfilcon A lenses assessed at days 3, 12, and 26 at hours 8:00 am, 12:00 pm, 4:00 pm, and 8:00 pm. Scale of 0-10 (0=painful, 10=can't feel the lenses).|Days 3, 12, 26|Number of participants analyzed may differ from participant flow due to protocol deviations.||units on a scale||Standard Deviation|Mean
850901|NCT00725764|Secondary|Duration of Stable Disease|Per RECIST v1.0 for target lesions and assessed by MRI: CR, Disappearance of all target lesions; Partial Response PR, >=30% decrease in the sum of the longest diameter of target lesions; OR = CR + PR. Duration of stable disease was defined as the time between the date of first dose of study drug and the first occurrence of 1 of the events: Tumor progression per RECIST as assessed by the investigator, Termination of study drug because of disease progression, Death due to disease progression, Disease progression as documented on the participant follow-up status form, Initiation of subsequent anticancer therapy.|Approximately up to 1 year|Safety Population. Analysis set included only participants whose best overall response was not disease progression.||Months||Full Range|Median
850902|NCT00725764|Secondary|Duration of Overall Survival|Overall survival was defined as the duration from the date of the first dose to the date of death. The start of a confounding anticancer therapy was treated as a censoring event. Every effort made to follow participant’s until death. Time to death was censored at the date of the latest participant contact or at the analysis cutoff date, if earlier. Kaplan-Meier method was used to estimate the overall survival distribution.|Approximately up to 1 year|Safety Population.||Months||Full Range|Median
850903|NCT00725764|Secondary|Duration of Progression-free Survival|Progression-free survival was defined as the duration from the date of first dose to the date of disease progression or date of death without documented progression or date of study termination + 1. The start of confounding anticancer therapy was not treated as a censoring event. Time to progression or death was censored at the study termination date or at the analysis cutoff date, if earlier.|Approximately up to 1 year|Safety Population.||Months||Full Range|Median
850904|NCT00725764|Primary|Number of Participants With Abnormalities in Urinalysis|Urinalysis parameters like appearance, color, pH, specific gravity, ketones, protein, glucose, bilirubin, nitrite, urobilinogen, and occult blood were performed. Number of participants with abnormalities are reported. In case of no abnormalities observed then it is reported as zero.|Week 5 [Day 29]|Safety population.||Participants|||Count of Participants
850905|NCT00725764|Primary|Number of Participants With Abnormalities of Common Toxicity Criteria for Adverse Events (CTCAE) Grade 3 in Laboratory Parameters (Clinical Chemistry and Hematology)|The National Cancer Institute -CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on the following general guideline: Grade 1: Mild AE, Grade 2: Moderate AE, Grade 3: Severe AE, Grade 4: Life-threatening or disabling AE and Grade 5: Death related to AE. Number of participants with abnormalities of CTCAE grade 3 in clinical chemistry parameters: alanine aminotransferase (ALT), γ-glutamyl transferase (GGT), phosphate, low sodium and hematology parameters: Leukocyte and Lymphocytes were presented.|Up to 20 months|Safety Population. Only those participants available at the specified time points were analyzed.||Participants|||Count of Participants
850906|NCT00725764|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Data for number of participants who presented one or more adverse events (serious or non serious) was reported. An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.|Up to 20 months|Safety Population.||Participants|||Count of Participants
850907|NCT00725764|Primary|Percentage of Participants With Objective Response Rate (ORR)|ORR was defined as the proportion of participants achieving best overall response of confirmed CR or PR divided by the total number of participants who received treatment. Per RECIST v1.0 for target lesions and assessed by MRI: CR, Disappearance of all target lesions; Partial Response PR, >=30% decrease in the sum of the longest diameter of target lesions; OR = CR + PR. Participants were evaluated for tumor response per RECIST. Percentage of participants with ORR were reported.|Approximately up to 1 year|Safety Population.||Percentage of participants||95% Confidence Interval|Number
850908|NCT00725764|Primary|Number of Participants Achieving Best Overall Response|Best overall response was assessed by the investigator per response evaluation criteria in solid tumors (RECIST). Per RECIST v1.0 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Tumor size was recorded at Baseline, and tumor response were recorded approximately every 8 weeks. Tumor response were classified by the investigator using RECIST criteria participant’s best response whether observed in the study treatment period or the treatment extension period was considered. The best overall response was the best response recorded from the start of treatment until disease progression/recurrence. Number of participants who achieved best overall response were recorded.|Approximately up to 1 year|safety population comprised of all participants who passed the screening criteria, enrolled in the study, and received at least 1 dose of study drug.||Participants|||Count of Participants
850914|NCT00715520|Secondary|Aim 3: Mean Peak Acceleration of Wrist Extension Movements|Mean peak acceleration was measured across study drug conditions prior to treatment (baseline), immediately after the treatment (post-training 1), 30 minutes after the treatment (post-training 2) and 60 minutes after the treatment (post-training 3). Increases in the mean peak acceleration of the trained wrist extension movements indicate motor learning. Acceleration was measured in g; a symbol for the average acceleration produced by gravity at the Earth's surface.|Baseline, Post-Training 1(Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes)|No sufficient data collected.|||||
850915|NCT00715520|Secondary|Aim 3: Mean Parameter Estimate for Maximal Motor Evoked Potential (MEPmax) Derived From Stimulus Response Curves (SRC)|Motor evoked potential (MEP) amplitudes were measured prior to treatment (baseline), immediately after the treatment (post-training 1), 30 minutes after the treatment (post-training 2), and 60 minutes after the treatment (post-training 3).The MEP is elicited by transcranial magnetic stimulation (TMS) at increased intensity. Its amplitude is measured from peak to peak and expressed in millivolts (mV). Measured MEP amplitudes were plotted against the intensity to create a stimulus response curve (SRC). SRCs were modeled by a 3- parameter sigmoid function and MEPmax was extracted. Long-lasting increases in MEP amplitude indicate increases in motor cortex excitability and are associated with motor learning.|Baseline, Post-Training 1(Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes)|No sufficient data collected.|||||
850916|NCT00715520|Secondary|Aim 2: Mean Peak Acceleration for rTMS Treatment With Respect to Frequency|Mean peak acceleration for the different frequencies of rTMS treatment (placebo, 0.1 Hz, 0.25 Hz, 0.5 Hz) prior to treatment (baseline), immediately after the treatment (post-training 1), 30 minutes after the treatment (post-training 2) and 60 minutes after the treatment (post-training 3). Increases in the mean peak acceleration of the trained wrist extension movements indicate motor learning. Acceleration was measured in g; a symbol for the average acceleration produced by gravity at the Earth's surface.|Baseline, Post-Training 1(Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes)|Analysis was completed in Aim 2 participants per protocol.||g||Standard Deviation|Mean
850917|NCT00715520|Secondary|Aim 2: Mean Sum of Normalized Motor Evoked Potentials (MEPs) for rTMS Treatment With Respect to Frequency|Mean sum of normalized MEP for the different frequencies of rTMS treatment (placebo at 0.1 Hz, 0.1 Hz, 0.25 Hz, 0.5 Hz) prior to treatment (baseline), immediately after the treatment (post-training 1), 30 minutes after the treatment (post-training 2) and 60 minutes after the treatment (post-training 3). Increases in the mean peak acceleration of the trained wrist extension movements indicate motor learning.|Baseline, Post-Training 1(Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes)|Analysis was completed in Aim 2 participants per protocol.||millivolts||Standard Deviation|Mean
850918|NCT00715520|Secondary|Aim 2: Mean Peak Acceleration of Wrist Extension Movements With Respect to Pulse|Mean peak acceleration of wrist movements for repeated TMS (rTMS) conditions with respect of the TMS pulse (-100, +300, placebo, zero) prior to treatment (baseline), immediately after the treatment (post-training 1), 30 minutes after the treatment (post-training 2) and 60 minutes after the treatment (post-training 3). Increases in the mean peak acceleration of the trained wrist extension movements indicate motor learning. Acceleration was measured in g; a symbol for the average acceleration produced by gravity at the Earth's surface.|Baseline, Post-Training 1(Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes)|Analysis was completed in Aim 2 participants per protocol.||g||Standard Deviation|Mean
850919|NCT00715520|Secondary|Aim 2: Mean Sum of Normalized Motor Evoked Potentials (MEPs) With Respect to Pulse|Mean sum of normalized MEP for repeated TMS (rTMS) conditions with respect to the pulse (-100, +300, placebo, zero) prior to treatment (baseline), immediately after the treatment (post-training 1), 30 minutes after the treatment (post-training 2) and 60 minutes after the treatment (post-training 3). Its amplitude is measured from peak to peak and expressed in mV. Long- lasting increases in MEP amplitude indicate increases in motor cortex excitability and are associated with motor learning.|Baseline, Post-Training 1(Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes)|Analysis was completed in Aim 2 participants per protocol.||millivolts||Standard Deviation|Mean
850920|NCT00715520|Primary|Aim 1: Mean Peak Acceleration of Wrist Extension Movements|Mean peak acceleration was measured across study drug conditions prior to treatment (baseline), immediately after the treatment (post-training 1), 30 minutes after the treatment (post-training 2) and 60 minutes after the treatment (post-training 3). Increases in the mean peak acceleration of the trained wrist extension movements indicate motor learning. Acceleration was measured in g; a symbol for the average acceleration produced by gravity at the Earth's surface.|Baseline, Post-Training 1 (Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes)|Analysis was completed in Aim 1 participants per protocol. One subject was not included in the analysis due to corrupt data.||g||Standard Deviation|Mean
850921|NCT00715520|Primary|Aim 1: Mean Parameter Estimate for Maximal Motor Evoked Potential (MEPmax) Derived From Stimulus Response Curves (SRC)|Motor evoked potential (MEP) amplitudes were measured prior to treatment (baseline), immediately after the treatment (post-training 1), 30 minutes after the treatment (post-training 2), and 60 minutes after the treatment (post-training 3).The MEP is elicited by transcranial magnetic stimulation (TMS) at increased intensity. Its amplitude is measured from peak to peak and expressed in millivolts (mV). Measured MEP amplitudes were plotted against the intensity to create a stimulus response curve (SRC). SRCs were modeled by a 3- parameter sigmoid function and MEPmax was extracted. Long-lasting increases in MEP amplitude indicate increases in motor cortex excitability and are associated with motor learning.|Baseline, Post-Training 1 (Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes)|Analysis was completed in Aim 1 participants per protocol for the placebo condition. One subject was not included in the analysis due to corrupt data.||mV||Standard Error|Mean
850924|NCT00692770|Other Pre-specified|The Correlation Between Plasma Biomarker Levels at Baseline With RFS to Determine Prognostic Value of Biomarkers - MET|Biomarker was analyzed at baseline [i.e., before treatment] as a dichotomized variable based on median biomarker levels, and dichotomized into “high” and “low” groups using an optimal max chi cut-off approach - not per intervention. As such, results were analyzed according to this stratification. Max-chi square methodology was used to search for the optimal cut point for dichotomization of each plasma biomarker and Kaplan-Meier curves were generated using the optimal cut point for each possible association examined. These biomarker analyses were retrospective and exploratory and of signal generating nature only.|At Baseline|Plasma biomarker analysis was done in 858 (77%) of the all enrolled subjects.||Days||95% Confidence Interval|Median
850925|NCT00692770|Other Pre-specified|The Correlation Between Plasma Biomarker Levels at Baseline With RFS to Determine Prognostic Value of Biomarkers - AFP|Biomarker was analyzed at baseline [i.e., before treatment] as a dichotomized variable based on median biomarker levels, and dichotomized into “high” and “low” groups using an optimal max chi cut-off approach - not per intervention. As such, results were analyzed according to this stratification. Max-chi square methodology was used to search for the optimal cut point for dichotomization of each plasma biomarker and Kaplan-Meier curves were generated using the optimal cut point for each possible association examined. These biomarker analyses were retrospective and exploratory and of signal generating nature only.|At Baseline|Plasma biomarker analysis was done in 858 (77%) of the all enrolled subjects.||Days||95% Confidence Interval|Median
850926|NCT00692770|Other Pre-specified|The Correlation Between Plasma Biomarker Levels at Baseline With RFS to Determine Prognostic Value of Biomarkers - ANG-2|Biomarker was analyzed at baseline [i.e., before treatment] as a dichotomized variable based on median biomarker levels, and dichotomized into “high” and “low” groups using an optimal max chi cut-off approach - not per intervention. As such, results were analyzed according to this stratification. Max-chi square methodology was used to search for the optimal cut point for dichotomization of each plasma biomarker and Kaplan-Meier curves were generated using the optimal cut point for each possible association examined. These biomarker analyses were retrospective and exploratory and of signal generating nature only.|At Baseline|Plasma biomarker analysis was done in 858 (77%) of the all enrolled subjects.||Days||95% Confidence Interval|Median
850927|NCT00692770|Other Pre-specified|Patient Reported Outcomes: Functional Assessment of Cancer Therapy (FACT)- General (G) Total Score|The PWB, FWB, SWB and EWB were summed to form the FACT-G total score. Subjects responded to each item on a 5-point Likert-type scale ranging from 0 (not at all) to 4 (very much). FACT-G scores ranged from 0 to 108 and the higher scores represented a better quality of life. The MID for the FACT-G total score was in the range of 6 to 7. The results on the ANCOVA analysis of time-adjusted AUC for the FACT-G score were reported.|Cycle (C) Day (D)1, C2D1, C3D1 and subsequent cycles up to C18, end of intervention visit|FAS included participants who were randomized to study treatments.||Unit on a scale||95% Confidence Interval|Least Squares Mean
850928|NCT00692770|Other Pre-specified|Patient Reported Outcomes: Functional Assessment of Cancer Therapy (FACT)- Hepatobiliary Subscale (HEP) Score|The FACT-HEP is a 45 item, self-administered, multi-dimensional, psychometrically sound questionnaire used extensively in oncology clinical trials. FACT-HEP consisted of five subscales: Physical Well-Being (PWB), Social Well-Being (SWB), Emotional Well-Being (EWB), Functional Well-Being (FWB), and Hepatobiliary Cancer Subscale (HCS). The PWB, FWB, SWB and EWB were summed to form the FACTGeneral (FACT-G) total score. The FACT-G and HCS scores were summed to form the FACT-HEP total score. FACT-HEP scores ranged from 0 to 180 and the higher scores represented a better quality of life. Subjects responded to each item on a 5-point Likert-type scale ranging from 0 (not at all) to 4 (very much). The minimally important difference (MID) for the FACT-Hep total score was in the range of 8 to 9. The results on the ANCOVA analysis of time-adjusted AUC for the FACT-HEP score were reported.|Cycle (C) Day (D)1, C2D1, C3D1 and subsequent cycles up to C18, end of intervention visit|FAS included participants who were randomized to study treatments.||Unit on a scale||95% Confidence Interval|Least Squares Mean
850929|NCT00692770|Other Pre-specified|Patient Reported Outcomes: Euroqol-5 Dimensions (EQ-5D) - Visual Analogue Scale (VAS) Score|The EQ-5D is a generic quality of life preference based on a validated instrument used in cancer and in general population, with 2 parts: Index and Visual Analogue Scale. The EQ-5D VAS is a measure that represents health status as a single value. It is a 20-centimetre vertical graduated visual analogue scale with scores that ranged from 0 (worst imaginable health state) to 100 (best imaginable health state). The respondent rated his/her current health state by drawing a line from the box marked ‘your own health state today’ to the appropriate point on the EQ-5D VAS. A 3-digit number (including leading zeros) was read off the scale from the point where the respondent’s line crossed the scale, which was the EQ-5D VAS score. A change of at least 7 points on the VAS was considered as minimally important. The results on the ANCOVA analysis of time-adjusted AUC for the EQ-5D VAS score were reported.|Cycle (C) Day (D)1, C2D1, C3D1 and subsequent cycles up to C18, end of intervention visit|FAS included participants who were randomized to study treatments.||Unit on a scale||95% Confidence Interval|Least Squares Mean
850930|NCT00692770|Other Pre-specified|Patient Reported Outcomes: Euroqol-5 Dimensions (EQ-5D) - Index Score|The EQ-5D is a generic quality of life preference based on a validated instrument used in cancer and in general population, with 2 parts: Index and Visual Analogue Scale. The EQ-5D Index is a descriptive system of the following health dimensions: mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression. Subjects were asked to choose any one of the 3 response levels for each dimension: no problems, some problems, and severe problems. The 5 health dimensions were summarized into a single score, the EQ-5D Index score which ranged from -0.59 to 1 with higher scores representing better health states (0=death, 1= perfect health, and -0.59=a health state worse than death). A change of at least 0.10 to 0.12 points was considered a minimally important difference using Eastern Cooperative Oncology Group Performance Status as the anchor. The results on the Analysis of covariance of timeadjusted Area under curve for the EQ-5D index score were reported.|Cycle (C) Day (D)1, C2D1, C3D1 and subsequent cycles up to C18, end of intervention visit|FAS included participants who were randomized to study treatments.||Unit on a scale||95% Confidence Interval|Least Squares Mean
850931|NCT00692770|Secondary|Overall Survival (OS)|"OS was defined as the time from randomization to date of death due to any cause. OS for subjects alive at the time of analysis was censored at their last date of contact. NA in the reported data indicates values could not be estimated due to censored data."|From randomization of the first subject until 4 years later.|FAS included participants who were randomized to study treatments.||Days||95% Confidence Interval|Median
850933|NCT00692770|Primary|Recurrence Free Survival (RFS) by Independent Assessment|Disease recurrence of HCC (intra or extra hepatic) was defined as the appearance of a new intrahepatic lesions fulfilling the American Association for the Study of Liver Diseases (AASLD) criteria of diagnosis of HCC or a new extra-hepatic lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.0. In addition to investigator assessment, all images were reviewed by an independent panel of radiologists. The calculation of the RFS was based on the independent evaluation of the scans. RFS was defined as the time from randomization to the first documented disease recurrence by independent radiological assessment or death due to any cause whichever occurred first. For subjects who had not recurred or died at the time of analysis, RFS was censored at their last date of evaluable scan before drop-out for any other reason than recurrence or death.|From randomization up to 4 years or until disease recurrence whichever came first|Full analysis set (FAS) included participants who were randomized to study treatments.||Days||95% Confidence Interval|Median
850934|NCT00657553|Secondary|Response Rate of Participants Given Bortezomib Alone|Fraction of participants on the pre-emptive institution of bortezomib (PIB) arm who convert from Partial Response(PR) to very good Partial Response (VGPR)or Complete Response (CR) and those in VGPR to CR|Three Years||||||
850935|NCT00657553|Primary|Effect of Maintenance Therapy With Bortezomib on the Length of Remission in Participants Currently Receiving Maintenance Therapy as Part of Total Therapy 2|"The number of patients on Bortezomib that have maintained event-free survival, compared to the patients on observation was not analyzed due to low attrition rates.
Event-free survival is a measure of the proportion of people who remain free of a particular complication of disease (called an event) after treatment that is designed to prevent or delay that particular complication."|three years||||||
850938|NCT00616200|Secondary|Sickness Impact Profile|Units of measurement on the Sickness Impact Profile were ordinal rated scored. Information on scoring use and interpretation of the Sickness Impact Profile, readers are encouraged to read Bergner et. al. 1981 - Bergner, M., Bobbit, R.A., Carter, W.B. et all (1981) the Sickness Impact Profile: Development and final revision of a health status measure. Medical Care, 19:787-805 The SIP measures sickness-related dysfunction based on behavior in order to provide a measure of health status that will aid in assessing the outcome of health care services.|At the end of four week VLCD|The scoring range is from no impairment with a score of 0, to significant impairment, with 5. Changes in score of 3.5 are considered clinically significant.||Scores on a scale||Standard Deviation|Mean
850939|NCT00616200|Secondary|Impact of Very Low Carbohydrate Diet on Stool Frequency|Stool Frequency was measured as number of stools per day|6 Weeks|Analysis was per protocol analysis||Stools Per day||Standard Deviation|Mean
850940|NCT00616200|Primary|"Number of Subjects Reporting Adequate Relief From IBS Symptoms for the Previous Week. Adequate Relief Was a True/False Item."|"Adequate relief was measured as the primary endpoint via a single item Adequate Relief Question asking Over the past week have you had adequate relief of your symptom experience. Higher scores represent greater levels of adequate relief over the week prior to the assessment. Participants completed this 1-item questionnaire at the end of each of weeks of the study, assessing whether they had adequate relief of their IBS symptoms for the week.
A responder was defined as reporting adequate relief in at least 2 of the 4 weeks on the VLCD."|At the end of each of 6 study weeks|||Participants|||Number
850941|NCT00612924|Primary|Freedom From Major Adverse Events|"The reported values represent the patients that did not experience a Major Adverse Event.
Participants did NOT experience:
All-Cause Mortality
Myocardial Infarction (MI)
Cerebrovascular Accident (CVA)
Renal Failure
Respiratory Failure
Paralysis or Paraplegia, or
Bowel Ischemia"|30 days|One Anaconda patient is not included in the analysis because their 30 day data was not reported.||percentage of patients||95% Confidence Interval|Number
850942|NCT00612924|Secondary|Secondary Effectiveness, Technical Success|Introduction and deployment of the Stent Graft in the absence of mortality, conversion to surgical repair, failed patency of both limbs, and evidence of a Type I or III endoleak through the first 24 hour post-operative period. The table below indicates the subjects who met the criteria for technical success based on Core Lab imaging evaluations.|24 hours|151 subjects (81 Anaconda and 70 ONE-LOK) had imaging available for core lab review and determination of technical success.||participants|||Number
850943|NCT00612924|Primary|Successful Aneurysm Treatment|"defined as a composite endpoint of subjects who have successful delivery and deployment of the Anaconda™ Stent Graft at the initial procedure and at ≤365 days post-procedure and absence of:
Aneurysm growth ≥ 5 mm as evaluated by the core laboratory
Post-operative interventions to correct type I or III endoleaks
Conversion to open surgical repair
Failed patency of both limbs
Migration requiring secondary procedure or intervention
Significant fracture
Aneurysm rupture"|365 days|In the ONE-LOK™ population, 85 subjects had efficacy endpoints and 9 subjects are missing due to withdrawal prior to 365-day follow-up. For the Anaconda population, 95 subjects had efficacy endpoints and 6 are missing data due to withdrawal prior to the 365-day follow-up.||percentage of patients||95% Confidence Interval|Number
850970|NCT00545844|Other Pre-specified|Patient Global Allergic Rhinitis Symptoms Assessment|At week 0 and week 8, patients were asked to complete one question describing their perception of their allergic rhinitis symptoms.|8 weeks (from Week 0 to Week 8)|319 patients advanced to the treatment phase and 313 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. The following results are based on the 301 patients who completed week 8.||Participants|||Number
850971|NCT00545844|Other Pre-specified|Physician Global Satisfaction|At week 0 and week 8, physicians were asked to complete a single question describing how satisfied they were regarding their patient’s asthma controller medication.|8 weeks (from Week 0 to Week 8)|319 patients advanced to the treatment phase and 313 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. The following results are based on the 301 patients who completed week 8.||Participants|||Number
850972|NCT00545844|Other Pre-specified|Patient Global Satisfaction|At week 0 and week 8, patients were asked to complete a single question describing how satisfied they were regarding their asthma controller medication.|8 weeks (from Week 0 to Week 8)|319 patients advanced to the treatment phase and 313 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. The following results are based on the 301 patients who completed week 8.||Participants|||Number
850973|NCT00545844|Secondary|Effectiveness of Montelukast Therapy Used in Combination With Inhaled Corticosteroids or Inhaled Corticosteroids / Long-Acting Beta 2-Agonist in Improving the Symptoms of Asthma Using the Asthma Control Questionnaire (ACQ)|The Asthma Control Questionnaire consists of 7 specific questions that were used to assess patient asthma control at week 0 and week 8. The mean score per question is used to determine the level of control, with a final score ranging from 0 (well-controlled) to 6 (extremely poorly controlled) units on a scale.|8 weeks (from Week 0 to Week 8)|There were 313 patients who qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit; of these, 300 patients completed the ACQ at week 8.||Units on a Scale||Standard Deviation|Mean
850974|NCT00545844|Secondary|The Mean Change in Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) Overall Score|Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) consists of 14 questions to assess patient's overall quality of life related to allergic rhinitis on a scale of 0 (least impairment) to 6 (greatest impairment). The score is the mean of the 14 questions, ranging from 0 to 6. Change is computed as Week 8 score – Week 0 score|8 weeks (from Week 0 to Week 8)|Based on ITT population; there were 286 patients with available data regarding the mean change in MiniRQLQ at week 8.||Units on a Scale||Standard Deviation|Mean
850975|NCT00545844|Primary|Asthma Control|Asthma control was assessed by the Canadian Asthma Consensus Guidelines at week 0 and week 8. Patients were considered uncontrolled if they answered “yes” to at least 2 of the 8 asthma control parameters.|8 weeks (from Week 0 to Week 8)|319 patients advanced to the treatment phase and 313 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. The following results are based on the 301 patients who completed week 8.||Participants|||Number
850976|NCT00534209|Secondary|Correlative Immunological Studies in Study Participants (Phase 2)|The time course of patients’ adaptive immune response to B7 vaccination as compared to control vaccine will be characterized by their CD8, CD4, and NK response (measured by ELI-spots for interferon-gamma (IFN-γ), interleukin 4 (IL-4), and granzyme B secretion) measured prior to vaccination (i.e. at baseline) and over two courses of vaccination (measurements at week 7 and 13).|Baseline, Week 7 and Week 13|This was an outcome measure for the Phase 2 portion of the study, which was never opened to accrual. No participants were enrolled in Phase 2 therefore no data were available.|||||
850977|NCT00534209|Secondary|Overall Survival (Phase 2)|The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that study participants are still alive.|Date of randomization to the recorded date of death|This was an outcome measure for the Phase 2 portion of the study, which was never opened to accrual. No participants were enrolled in Phase 2 therefore no data were available.|||||
850978|NCT00534209|Secondary|Response to Second-line Chemotherapy After Disease Progression (Phase 2)|The percentage of patients experiencing a clinical response (complete response (CR), partial response (PR), stable disease (SD)) on second-line chemotherapy will be characterized for B7-vaccinated patients and controls.|From Week 1 of Study Therapy until Death or Withdrawal of Consent|This was an outcome measure for the Phase 2 portion of the study, which was never opened to accrual. No participants were enrolled in Phase 2 therefore no data were available.|||||
850979|NCT00534209|Secondary|Safety Profile (Phase 2)|The rate of patients experiencing toxicity over the course of treatment will be characterized by type of toxicity and grade, and by the time of toxicity onset in relation to day of vaccination.|About 13 weeks|This was an outcome measure for the Phase 2 portion of the study, which was never opened to accrual. No participants were enrolled in Phase 2 therefore no data were available.|||||
850980|NCT00534209|Secondary|Relationship of CD8 Response in B7-vaccinated Patients to Their Progression-free Survival.(Phase 2)|Relationship of CD8 response in B7-vaccinated patients to their progression-free survival. Summarized by the median and range of follow up time for patients grouped according to disease status (progression/no progression) and vital status (died/alive at last contact).|From Week 1 of Study Therapy until Death or Withdrawal of Consent|This was an outcome measure for the Phase 2 portion of the study, which was never opened to accrual. No participants were enrolled in Phase 2 therefore no data were available.|||||
850981|NCT00534209|Secondary|Immune Response (CD8) in B7-vaccinated Participants as Compared to Controls. (Phase 2)|Rate of immune response (CD8) in B-7 vaccinated participants reported for measurements taken immediately prior to vaccination (week 0) and throughout the two courses.|About 13 weeks|This was an outcome measure for the Phase 2 portion of the study, which was never opened to accrual. No participants were enrolled in Phase 2 therefore no data were available.|||||
850982|NCT00534209|Primary|Progression-free Survival (Phase 2)||Date of randomization to the earliest date of documented progression.|This was an outcome measure for the Phase 2 portion of the study, which was never opened to accrual. No participants were enrolled in Phase 2 therefore no data were available.|||||
850983|NCT00534209|Primary|Preliminary Safety Profile (Phase 1)|This will include the number of patients experiencing toxicity over the course of treatment, characterized by type of toxicity and grade, and by the time of toxicity onset in relation to day of vaccination.|Up to 13 weeks|||participants|||Number
850992|NCT00494442|Secondary|Progression-Free Survival (PFS)|Progression-Free Survival (PFS) is defined as the time from first dose to the earlier date of radiologic progression (as per RECIST criteria) or death by any cause in the absence of objective progression.|End of study|||Days||95% Confidence Interval|Median
850993|NCT00494442|Secondary|Best Percentage Change in Tumour Size|The best % change (reduction) from baseline in tumour size (defined as the sum of the longest diameters as measured among all target lesions).|End of study|||Percentage||Full Range|Median
850994|NCT00494442|Secondary|Duration of Response|Duration of response to olaparib|End of study|||Days||Full Range|Median
850995|NCT00494442|Secondary|Clinical Benefit (CB)|Clinical Benefit (CB) is defined as the percentage of patients with a RECIST tumour response of confirmed complete response, partial response or stable disease for ≥8 weeks)|End of study|||Percentage of participants||95% Confidence Interval|Number
850996|NCT00494442|Primary|Confirmed Objective Tumour Response (According to Response Evaluation Criteria In Solid Tumors (RECIST)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease from baseline in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Baseline, every 8 also at study termination or initiation of confounding anti-cancer therapy.|||Participants|||Number
850997|NCT00218296|Primary|Percent Prolonged Abstinence From Tobacco at Week 32|Continuous Abstinence from quit date through Week 32 (Assessed at Week 32 for Usual Care and Week 26 for Reduction Group, Reduction Group's quit date is 6 weeks later than Usual Care).|32 Weeks|||percentage of randomized|||Number
850998|NCT00218296|Primary|Percent Abstinent From Tobacco at Week 32 (7 Day Point Prevalence)|Abstinence from tobacco 7 days prior to Week 26 (Assessed at Week 32 for Usual Care and Week 26 for Reduction Group. Reduction Group's quit date is 6 weeks later than Usual Care).|32 Weeks|||percentage of randomized|||Number
850999|NCT00218296|Primary|Percent Prolonged Abstinence From Tobacco at Week 26|Continuous Abstinence from quit date through Week 26 (Assessed at Week 26 for Usual Care and Week 20 for Reduction Group, Reduction Group's quit date is 6 weeks later than Usual Care).|26 weeks|Intent to treat||percentage of randomized|||Number
851000|NCT00218296|Primary|Percent Abstinent From Tobacco at Week 26 (7 Day Point Prevalence)|Abstinence from tobacco 7 days prior to Week 26 (Assessed at 26 weeks for Usual Care and 20 weeks for Reduction Group post-quit date)|26 week|||percentage of randomized|||Number
851001|NCT00218296|Primary|Percent Prolonged Abstinence From Tobacco at Week 12|Continuous tobacco cessation from quit date through Week 12 verified by biomarkers (urine, cotinine and CO)|12 weeks|||percentage of randomized|||Number
851002|NCT00218296|Primary|Percent Abstinent From Tobacco at Week 12 (7 Day Point Prevalence)|No tobacco use 7 days prior to Week 12 verified by biomarkers (urine, cotinine and CO)|12 weeks|Intent to treat||percentage of randomized|||Number
851013|NCT00189540|Secondary|Change in Hemodynamic Measurements - Mean Change in Toe Brachial Index (TBI)||Baseline, Month 3, Month 6|Population is per protocol - Efficacy Evaluable (EE)||mm Hg / mm Hg||Standard Error|Mean
851014|NCT00189540|Secondary|Change in Hemodynamic Measurements - Mean Change in Ankle Brachial Index (ABI)||Baseline, Month 3, Month 6|Population is per protocol - Efficacy Evaluable (EE)||mm Hg / mm Hg||Standard Error|Mean
851015|NCT00189540|Secondary|Number of Subjects Who Undergo a Major Amputation||Month 3 and Month 6|||participants|||Number
851016|NCT00189540|Secondary|Change in Pain at Rest as Measured on the Visual Analog Scale (VAS)|The mean VAS score where 0 = no pain; 10 = worst possible pain.|Baseline, Month 3 and Month 6|"Per protocol population or Efficacy Evaluable EE"||cm||Standard Error|Mean
851017|NCT00189540|Secondary|Percentage of Participants Where All Ulcers Healed|This outcome is a percentage of participants where all of their baseline ulcers healed.|Month 3 and Month 6|"Per protocol population Efficacy Evaluable EE"||Percentage of Participants|||Number
851018|NCT00189540|Primary|Wound Healing (Change in Total Wound Area of All Ischemic Ulcers)|Wound healing measured by change in mean total wound area of all ischemic ulcers at Month 3 and Month 6|Baseline, Month 3, Month 6|Per protocol population - Efficacy Evaluable or EE||total wound area (cm^2)||Standard Error|Mean
851025|NCT00151411|Secondary|Change in Insulin Sensitivity Index After 6 Months of Treatment||baseline and 6 months|||indice||95% Confidence Interval|Least Squares Mean
851026|NCT00151411|Secondary|Ovulation Rate|Ovulation is defined as a binary outcome; ovulated at least once vs. did not ovulate during the treatment period.|6 months|A total of 76 patients with daily urine collections.||Participants|||Count of Participants
851027|NCT00151411|Primary|Change in Testosterone After 6 Months of Treatment||baseline and 6 months|||ng/dL||95% Confidence Interval|Least Squares Mean
851028|NCT00130728|Secondary|Duration of Objective Response|Duration of objective response was defined as the period from the date of the initial partial or complete response until the date of disease progression or death on study treatment from any cause. For patients who had not died, data was censored at the date of last contact.|Period from Objective response until disease progression or death on study treatment. (Up to 29.5 months)|Patients with an objective response||months||95% Confidence Interval|Median
851029|NCT00130728|Secondary|Percentage of Participants With Objective Response|Objective response was defined as a complete or partial response determined by RECIST on two consecutive occasions >= 4 weeks apart.|The median duration of Objective response was up to 9.7 months|Only patients with measurable disease at baseline were included in the analysis of the objective response. Patients without a post-baseline tumor assessment were considered non-responder.||Percentage of participants||95% Confidence Interval|Number
851030|NCT00130728|Secondary|Progression-free Survival (PFS)|PFS was defined as the time from randomization to documented disease progression, as determined by the investigator using the Response Evaluation Criteria in Solid Tumors (RECIST), or death on study treatment, whichever occurred first.|From randomization to documented disease progression or death on study treatment, whichever occurred first. (Up to 3.1 years)|Randomized patients||months||95% Confidence Interval|Median
851031|NCT00130728|Primary|Overall Survival (OS) Among All Randomized Patients|Overall Survival was defined as the period from the date of randomization until the date of patient death from any cause. For patients who had not died, survival data was censored at the date of last contact.|From the date of randomization until the date of patient death from any cause, or the date of last contact. (Up to 3.1 years)|Randomized patients||months||95% Confidence Interval|Median
851032|NCT00113919|Primary|Maximal Dose of Busulfex® Given in a 2, 3, or 4 Day Period With Acceptable Toxicity to Myeloma Patients|maximal dose of Busulfex® that can be given in a two, three, or four day period with acceptable toxicity to myeloma patients, who either are > or = 65 years of age or have renal insufficiency, defined as creatinine > 3g/dL or creatinine clearance < 30 ml/min|three years||||||
851033|NCT00105560|Secondary|Overall Survival|the percentage of participants surviving after five and seven years and at the end of follow-up in the overall population. Survival is shown by risk and histological group.|5 years, 7 years, 10 years|Follow-up for the 10 year follow-up is still ongoing and the data is not yet available.||percentage of participants surviving||95% Confidence Interval|Number
851034|NCT00105560|Secondary|Progression Free Survival|The percentage of participants with progression free survival after five, seven, and ten years in the overall population and by risk and histological group.|5 years, 7 years, 10 years|Follow-up is ongoing and data is not yet available for the 10 year follow-up time point.||percentage of participants surviving||95% Confidence Interval|Number
851035|NCT00105560|Secondary|Mean Change Per-Year in Neurocognitive Outcomes|The mean change per-year in neurocognitive outcomes as assessed by Wechsler Intelligence Scale for Children version 4 (WISC-IV). The test measures the Full Scale Intelligence Quotient (FSIQ) of children with the use of four indices; the Verbal Comprehension Index (VCI), Perceptual Reasoning Index (PRI), working memory test, and a processing speed test. FSIQ and the four indices are all assessed on a bell curve scale that has an average score of 100 and standard deviation of 15 points in the general population, meaning on average 68% of test takers would be within +/- 15 points of 100 and 95% within +/- 30 points. Higher scores represent higher intelligence and lower score represent reduced intelligence. Participants were assessed for changes in score with the use of repeated testing during a median follow-up time of 5.2 years. Repeated measures were taken at baseline, 1, 3, 5, and 7 years or until the participant was not available for evaluation (whichever comes first).|Baseline, 1, 3, 5, 7 years|The study participants that were evaluated for changes in neurocognitive outcomes||units on a scale||95% Confidence Interval|Mean
851036|NCT00105560|Secondary|Cumulative Incidence of Endocrine Dysfunction (Neuroendocrine and End Organ Defects) at 10 Years|percentage of participants who experienced endocrine dysfunction (neuroendocrine and end organ defects) by the end of study follow-up (as determined by CTCAE 3.0) by hormone type and risk group.|End of follow-up||12/2021||||
851037|NCT00105560|Secondary|Cumulative Incidence of Endocrine Dysfunction (Neuroendocrine and End Organ Defects) at 7 Years|Percentage of participants who experienced endocrine dysfunction (neuroendocrine and end organ defects) after 7 years of follow-up, as determined by CTCAE 3.0. Incidence is shown by hormone type and risk group|7 years|||percentage of participants||95% Confidence Interval|Number
851038|NCT00105560|Secondary|Cumulative Incidence of Endocrine Dysfunction (Neuroendocrine and End Organ Defects) at 5 Years|Percentage of participants who experienced endocrine dysfunction (neuroendocrine and end organ defects) after 5 years of follow-up (as determined by CTCAE 3.0). Incidence is shown by hormone type and risk group.|5 years|||percentage of participants||95% Confidence Interval|Number
851039|NCT00105560|Secondary|Cumulative Incidence of Endocrine Dysfunction (Neuroendocrine and End Organ Defects) at 3 Years|Percentage of participants who experienced endocrine dysfunction (neuroendocrine and end organ defects) after 3 years of follow-up (as determined by CTCAE 3.0). Incidence is grouped by hormone type and risk group|3 years|||percentage of participants||95% Confidence Interval|Number
851040|NCT00105560|Primary|Cumulative Incidence of Ototoxicity|Percentage participants who experienced ototoxicity as measured by Common Toxicity Criteria for Adverse Events (CTCAE) v3.0 after the completion of radiation therapy in the overall participant population and by baseline measure subgroups. Incidence is shown after follow-up of 3 years, 5 years, 7 years, and 10 years.|3 Years, 5 years, 7 years, 10 years|The overall study population after the stated durations of follow-up. Follow-up is ongoing and data is not yet available for the 10 year time point.||percentage of participants||95% Confidence Interval|Number
851041|NCT00083915|Secondary|Side Effects With DT PACE-Melphalan vs Side Effects With Melphalan Alone|Compare side effects with the new regimen of DT PACE-Melphalan, compared to melphalan alone|3 years depending on start date||||||
851042|NCT00083915|Primary|Transplant With DT PACE-Melphalan Regimen of Chemotherapy vs. Transplant With Melphalan Alone.|Compare a new regimen of chemotherapy called DT PACE-Melphalan (new experimental therapy) is better than transplant with Melphalan alone (standard therapy)|3 years depending on start date|only 2 participants in high dose (HD) melphalan group completed the study and only 8 from the Mel-DT Pace group completed the study. No analysis done.|||||
851061|NCT00054353|Secondary|Response Rate|Number of subjects who achieved CR post-transplant. Response rate will be summarized using cumulative incidence estimates.|Up to 5 years|||Participants|||Count of Participants
851062|NCT00054353|Secondary|Relapse Rate|Number of subjects who relapsed after achieving CR post-transplant. Relapse rate will be summarized using cumulative incidence estimates.|Up to 5 years|||Participants|||Count of Participants
851063|NCT00054353|Secondary|Engraftment|Number of subjects who engrafted post-transplant. Engraftment will be monitored in a sequential fashion.|Up to 5 years|||Participants|||Count of Participants
851064|NCT00054353|Secondary|OS|Number of subjects surviving. OS will be estimated by the method of Kaplan and Meier. Confidence intervals will be estimated.|At 6 months and then every year thereafter, up to 5 years|||Participants|||Count of Participants
851065|NCT00054353|Primary|Incidence of Chronic (Extensive) GVHD|Number of subjects with chronic extensive GVHD post-transplant. Severe GVHD will be monitored in a sequential fashion.|Up to 5 years|||Participants|||Count of Participants
851066|NCT00054353|Primary|Incidence of Acute GVHD (Grades III-IV)|Number of patients with Grade III-IV acute GVHD post-transplant. Severe GVHD will be monitored in a sequential fashion.|Up to 5 years|||Participants|||Count of Participants
851067|NCT00054353|Primary|Non-relapse Mortality|Early NRM will be monitored in a sequential fashion.|At day 100|||Participants|||Count of Participants
851068|NCT00054353|Primary|PFS|PFS will be calculated for all patients from the date of transplant until the time of progression, relapse, death, or the date the patient was last known to be in remission. Progressive disease is defined as greater than 25% increase in serum or urine M proteins compared to best response status after autologous transplant and/or appearance of new lytic bone lesions or plasmocytomas.|At 1 year post-transplant|There were 4 patients who, although they did not have progression/relapse, died before the 1 year mark, and thus are not included in the 1 year PFS count.||Participants|||Count of Participants
851082|NCT00001596|Secondary|Change in 6 Minute Walk Test (12 Months)|Change from baseline of the 6 minute walk test (6MWT) at 12 months. The 6MWT measures the distance that a patient can quickly walk on a flat hard surface in a period of six minutes.|Measured at baseline and 12 months|Participants from the Intent to Treat population for whom data is available at baseline and 12 months.||meters||Standard Deviation|Mean
851083|NCT00001596|Secondary|Change in 6 Minute Walk Test (36 Months)|Change from baseline of the 6 minute walk test (6MWT) at 36 months. The 6MWT measures the distance that a patient can quickly walk on a flat hard surface in a period of six minutes.|Measured at baseline and 36 months|Participants from the Intent to Treat population for whom data is available at baseline and 36 months.||meters||Standard Deviation|Mean
851084|NCT00001596|Secondary|Change in Adjusted Diffusing Capacity of the Lung for Carbon Monoxide (12 Months)|Change from baseline in adjusted Diffusing Capacity of the lung for carbon monoxide (DLCOa) measured at 12 months. DLCOa measures gas uptake during a single inspiration in a standard time, adjusted for subject's hemoglobin levels.|Measured at baseline and 12 months|Participants from the Intent to Treat population for whom data is available at baseline and 12 months.||% of predicted volume||Standard Deviation|Mean
851085|NCT00001596|Secondary|Change in Adjusted Diffusing Capacity of the Lung for Carbon Monoxide (36 Months)|Change from baseline in adjusted Diffusing Capacity of the lung for carbon monoxide (DLCOa) measured at 36 months. DLCOa measures gas uptake during a single inspiration in a standard time, adjusted for subject's hemoglobin levels.|Measured at baseline and 36 months|Participants from the Intent to Treat population for whom data was available at baseline and 36 months.||% of predicted volume||Standard Deviation|Mean
851086|NCT00001596|Secondary|Change in Total Lung Capacity (12 Months)|Change from baseline in Total Lung Capacity (TLC) measured at 12 months. TLC is the volume in the lungs at maximal inflation. TLC is recorded as the percentage of predicted volume based on subject's height, age, sex, and weight.|Measured at baseline and 12 months|Participants from the Intent to Treat population for whom data was available at baseline and 12 months.||% of predicted volume||Standard Deviation|Mean
851087|NCT00001596|Secondary|Change in Total Lung Capacity (36 Months)|Change from baseline in Total Lung Capacity (TLC) measured at 36 months. TLC is the volume in the lungs at maximal inflation. TLC is recorded as the percentage of predicted volume based on subject's height, age, sex, and weight.|Measured at baseline and 36 months|Participants from the Intent to Treat population for whom data is available at baseline and 36 months.||% of predicted volume||Standard Deviation|Mean
851088|NCT00001596|Secondary|Change in Forced Vital Capacity (12 Months)|Change from baseline in the Forced Vital Capacity (FVC) measurement at 12 months. FVC is the volume of air that can be forcibly blown out from the lungs after full inspiration. FVC is recorded as the percentage of predicted volume (predicted FVC volume is calculated based on subject's height, age, sex, and weight).|Measured at baseline and 12 months|Participants from the Intent to Treat population for whom data was available at baseline and 12 months.||% of predicted volume||Standard Deviation|Mean
851089|NCT00001596|Primary|Change in Forced Vital Capacity (36 Months)|Change from baseline in the Forced Vital Capacity (FVC) measurement at 36 months. FVC is the volume of air that can be forcibly blown out from the lungs after full inspiration. FVC is recorded as the percentage of predicted volume (predicted FVC volume is calculated based on subject's height, age, sex, and weight).|Measured at baseline and 36 months|Participants from the Intent to Treat population for whom data was available at baseline and 36 months.||% of predicted volume||Standard Deviation|Mean
851090|NCT02847260|Secondary|Change From Baseline to Week 16 in HemodynamicParameters: Pulmonary Vascular Resistance Index (PVRI) (mmHg*Min*m^2/L)|Pulmonary Vascular Resistance Index (PVRI) is calculated using Mean Pulmonary Arterial Pressure(PAPm), Pulmonary Capillary Wedge Pressure (PCWP) and Cardiac Index (CI ), to provide information about right ventricular load. The PVRI values and their respective changes from Baseline to Week 16 were measured by SwanGanz right heart catheterization.|Baseline to week 16|Only 29 of the 32 subjects that completed the 16 week treatment period completed these hemodynamic assessments.||mmHg*min*m^2/L||Standard Deviation|Mean
851091|NCT02847260|Secondary|Change From Baseline to Week 16 in Hemodynamic Parameters: Cardiac Index (CI) (L/Min/m^2)|Cardiac Index (CI) relates the cardiac output (CO) to body surface area (BSA), thus relating heart performance to the size of the individual. The CI values and their respective changes from Baseline to Week 16 were measured by SwanGanz right heart catheterization and summarized.|Baseline to week 16|Only 29 of the 32 subjects that completed the 16 week treatment period completed these hemodynamic assessments.||L/min/m^2||Standard Deviation|Mean
851092|NCT02847260|Secondary|Change From Baseline to Week 16 in Hemodynamic Parameters: Mean Pulmonary Artery Pressure (PAPm), Mean Right Atrial Pressure (RAPm) and Mean Pulmonary Capillary Wedge Pressure (PCWPm).|Pulmonary hypertension, an increase in pressure in the pulmonary vasculature defined as a mean pulmonary artery pressure (PAPm) greater than 25 mmHg at rest or greater than 30 mmHg with exercise, as measured by Swan-Ganz right heart catheterization. The PAPm, RAPm and PCWPm values and their respective changes from Baseline to Week 16 were measured by SwanGanz right heart catheterization and summarized.|Baseline to week 16|Only 29 of the 32 subjects that completed the 16 week treatment period completed these hemodynamic assessments.||mmHG||Standard Deviation|Mean
851093|NCT02847260|Secondary|Change in Quality of Life (QoL) Assessment: Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) From Baseline to Week 16.|The CAMPHOR is a health related quality of life instrument validated for pulmonary hypertension that assesses impairment (symptoms), disability (activities) and quality of life. The questionnaire is divided into three sections; Symptoms (Scores 0-25; high scores indicate more symptoms), Activity (Score 0-30; low score indicates good functioning) and Quality of Life (0-25; high scores indicate poor QoL). The sum of these scores equates to the Total score (0-80). In the CAMPHOR scores, negative change scores indicate improvements.|Baseline to week 16|Scores could not be tabulated for one subject due to missing responses to individual questions||units on a scale||Full Range|Median
851094|NCT02847260|Secondary|Number of Participants With a Change From Baseline World Health Organization (WHO) Functional Classification at Week 16.|The WHO Functional Class of pulmonary hypertension is a physical activity rating scale as follows: Class I: No limitation of physical activity. Class II: Slight limitation of physical activity. Class III: Marked limitation of physical activity. Class IV: Inability to carry out any physical activity without symptoms.|Baseline to week 16|||Participants|||Count of Participants
851095|NCT02847260|Secondary|Change in N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) Concentrations From Baseline to Week 16.|The level of this biomarker of the (NT-proBNP) serum concentration was assessed to compare the severity of heart failure at Baseline and Week 16.|Baseline to week 16|||pg/mL||Full Range|Median
851096|NCT02847260|Secondary|Change in Borg Dyspnea Score (Following 6MWT) From Baseline to Week 16|The Borg dyspnea score is a 10 point scale rating the maximum level of dyspnea (difficulty in breathing) experienced during the 6MWT. The Borg dyspnea score was assessed immediately following the 6MWT. Scores range from 0 (for no shortness of breath) to 10 (for the greatest shortness of breath ever experienced).|Baseline to week 16|Two subjects that completed the treatment period did not complete the six minute walk test at week 16. As such, the evaluable data for the six minute walk test at Week 16 was summarized using an N of 30 subjects.||units on a scale||Full Range|Median
851097|NCT02847260|Secondary|Change From Baseline in Six Minute Walk Distance at Week 16.|The purpose of the six minute walk test (6MWT) was to evaluate exercise capacity associated with carrying out activities of daily living. Patients were instructed to walk down a corridor at a comfortable speed as far as they could manage for six minutes, resting whenever they needed. Distance <500 meters suggests considerable exercise limitation; Distance 500 - 800 meters suggests moderate limitation; Distance >800 meters (with no rests) suggests mild or no limitation.|Baseline to week 16|Two subjects that completed the treatment period did not complete the six minute walk test at week 16. As such, the evaluable data for the six minute walk test at Week 16 was summarized using an N of 30 subjects.||meters||Full Range|Median
851098|NCT02847260|Primary|Number of Participants With Successful Completion of the 16 Week Treatment Period.|Successful completion was defined as completion of the 16 week treatment period of the study without experiencing any serious adverse events considered by the investigator to be possibly related to Remodulin.|Baseline to week 16|||participants|||Number
851099|NCT02829983|Secondary|Probing Depth|Distance from the bottom of sulcus/pocket to gingival margin|6 months|||milimeter||Standard Deviation|Mean
851100|NCT02829983|Primary|Clinical Attachment Level|Distance from bottom of pocket to the cement-enamel junction (CEJ).|6 months|||milimeter||Standard Deviation|Mean
851107|NCT02596022|Primary|Number of Choices to Self-administer Cocaine (Out of 5 Choices)|Participants provided 5 choices (cocaine 25 mg now vs. $11 later), with choices spaces 15 minutes apart over the course of the session.|24 hours post-infusion|||number of cocaine choices||Standard Deviation|Mean
851108|NCT02556333|Primary|HIV RNA Change From Baseline to Day 10|An HIV RNA decline of >=0.5 log by day 10 will be considered to be an adequate virologic response, to proceed to the second phase of the study.|10 days|One patient with multiple drug resistant HIV infection enrolled into this study.||log HIV RNA copies/mL|||Number
851126|NCT02461966|Primary|Serum Aflatoxin Level in Liver Cancer Patients|Serum aflatoxin level in liver cancer patients in comparison to liver cirrhosis and controls.|6 months|||ng\ml||Standard Deviation|Mean
851143|NCT02359890|Secondary|Rate of Acute Success|Acute success is defined as confirmation of entrance block in all Pulmonary veins (PV).|End of procedure|Safety Population (SP), which is defined as the enrolled subjects who had the study catheter inserted.||Percentage of participants||95% Confidence Interval|Number
851144|NCT02359890|Secondary|Incidence of Non-Primary Serious Adverse Events (SAEs)|This secondary safety endpoint includes non-primary serious adverse events (SAEs) within 7 days post-procedure and serious adverse events from 8 days to 30 days post-procedure|Up to 30 days post Procedure|Safety Population (SP), which is defined as the enrolled subjects who had the study catheter inserted.||Percentage of Participants|||Number
851145|NCT02359890|Primary|Incidence of Early Onset Primary Adverse Events|Early onset is defined as within 7 days of the atrial fibrillation (AF) ablation procedure. Primary adverse events (AE) include Death, Myocardial infarction (MI), Pulmonary vein (PV) stenosis, Diaphragmatic paralysis, Atrio-esophageal fistula, Transient Ischemic Attack (TIA), Stroke / Cerebrovascular accident (CVA), Thromboembolism, Pericarditis, Cardiac Tamponade / Perforation, Pneumothorax, Major Vascular Access Complications / Bleeding, Pulmonary edema (Respiratory Insufficiency), and Heart block.|Seven days post ablation procedure|The modified intent-to-treat (mITT) population was used, which consisted of enrolled subjects who met the eligibility criteria and had the study catheter inserted.||Percentage of participants||95% Confidence Interval|Number
851191|NCT02260986|Other Pre-specified|Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score to Week 16|ACQ-5 questionnaire was a validated questionnaire comprising of 5 questions for asthma symptoms: woken at night by symptoms, wake in the mornings with symptoms, limitation of daily activities, shortness of breath, and wheeze. Participants were asked to rate their asthma symptoms during the previous week on a 7-point scale as 0=no impairment, 6=maximum impairment. ACQ-5 score was the mean of the 5 questions and range between 0 (totally controlled) and 6 (severely uncontrolled) (a higher score indicated lower asthma control). The ACQ-5 questionnaire was administered only to the participants with a medical history of asthma.|Baseline to Week 16|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with ACQ-5 value at baseline.||units on a scale||Standard Error|Least Squares Mean
851192|NCT02260986|Other Pre-specified|Change From Baseline in Sinonasal Outcome Test (SNOT-22) Score to Week 16|The SNOT 22 was a validated measure of health related quality of life in sinonasal disease. It was a 22 item questionnaire with each item assigned a score ranging from 0-5. The total score may range from 0 (no disease) -110 (worst disease) (lower scores represent better health related quality of life). The SNOT-22 was administered only to participants with chronic inflammatory conditions of the nasal mucosa and/or paranasal sinuses.|Baseline to Week 16|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with available data for this endpoint.||units on a scale||Standard Error|Least Squares Mean
851193|NCT02260986|Secondary|Number of Skin Infection Treatment Emergent Adverse Events (TEAEs) (Excluding Herpetic Infections) Requiring Systemic Treatment From Baseline Through Week 52|Any untoward medical occurrence in a participant who received IMP was considered an AE without regard to possibility of causal relationship with this treatment. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to end of treatment at Week 52). Any TEAE included participants with both serious and non-serious AEs. Skin infection TEAEs were identified based on blinded adjudication of all reported TEAEs under the 2 primary System Organ Classes (SOC): SOC = “Infection and Infestations” or SOC = “Skin and Subcutaneous Tissue Disorders”. Blinded adjudication was performed and finalized by the study medical monitor before database lock.|Baseline up to Week 52|All safety analysis were performed on SAF that included all randomized participants who received any study drug, and was analyzed as-treated.||events|||Number
851194|NCT02260986|Secondary|Percentage of Participants With Skin Infection Treatment Emergent Adverse Events (TEAEs) (Excluding Herpetic Infections) Requiring Systemic Treatment From Baseline Through Week 52|Any untoward medical occurrence in a participant who received IMP was considered an AE without regard to possibility of causal relationship with this treatment. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to end of treatment at Week 52). Any TEAE included participants with both serious and non-serious AEs. Skin infection TEAEs were identified based on blinded adjudication of all reported TEAEs under the 2 primary System Organ Classes (SOC): SOC = “Infection and Infestations” or SOC = “Skin and Subcutaneous Tissue Disorders”. Blinded adjudication was performed and finalized by the study medical monitor before database lock.|Baseline up to Week 52|All safety analysis were performed on SAF that included all randomized participants who received any study drug, and was analyzed as-treated.||percentage of participants|||Number
851195|NCT02260986|Secondary|Number of Skin Infection TEAEs (Excluding Herpetic Infections) From Baseline Through Week 52|Any untoward medical occurrence in a participant who received IMP was considered an AE without regard to possibility of causal relationship with this treatment. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to end of treatment at Week 52). Any TEAE included participants with both serious and non-serious AEs. Skin infection TEAEs were identified based on blinded adjudication of all reported TEAEs under the 2 primary System Organ Classes (SOC): SOC = “Infection and Infestations” or SOC = “Skin and Subcutaneous Tissue Disorders”. Blinded adjudication was performed and finalized by the study medical monitor before database lock.|Baseline up to Week 52|All safety analysis were performed on SAF that included all randomized participants who received any study drug, and was analyzed as-treated.||events|||Number
851196|NCT02260986|Secondary|Percentage of Participants With Skin Infection Treatment Emergent Adverse Events (TEAEs) (Excluding Herpetic Infections) From Baseline Through Week 52|Any untoward medical occurrence in a participants who received IMP was considered an AE without regard to possibility of causal relationship with this treatment. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to end of treatment at Week 52). Any TEAE included participants with both serious and non-serious AEs. Skin infection TEAEs were identified based on blinded adjudication of all reported TEAEs under the 2 primary System Organ Classes (SOC): SOC = “Infection and Infestations” or SOC = “Skin and Subcutaneous Tissue Disorders”. Blinded adjudication was performed and finalized by the study medical monitor before database lock.|Baseline up to Week 52|All safety analysis were performed on SAF that included all randomized participants who received any study drug, and was analyzed as-treated.||percentage of participants|||Number
851197|NCT02260986|Secondary|Number of Serious Treatment Emergent Adverse Events (TEAEs) Leading to Study Drug Discontinuation Through Week 52|Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. A Serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.|Baseline up to Week 52|All safety analysis were performed on SAF that included all randomized participants who received any study drug, and was analyzed as-treated.||events|||Number
851198|NCT02260986|Secondary|Number of Flares Through Week 52|Atopic dermatitis (AD) flares were defined as worsening of the disease that required escalation/intensification of AD treatment. Number of flares occurred in the participants starting from first dose through Week 52 were reported.|Baseline up to Week 52|All safety analysis were performed on safety analysis set (SAF) that included all randomized participants who received any study drug, and were analyzed as-treated.||flares|||Number
851199|NCT02260986|Secondary|Change From Baseline in Hospital Anxiety Depression Scale (HADS) to Week 52|HADS is a fourteen item scale. Seven of the items relate to anxiety and seven items relate to depression. Each item on the questionnaire is scored from 0 (minimum score) - 3 (maximum score) and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression. Cut-offs for identifying psychiatric distress has been reported as 7 to 8 for possible presence, 10 to 11 for probable presence, and 14 to 15 for severe anxiety or depression.|Baseline to Week 52|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with available data for this endpoint.||units on a scale||Standard Error|Least Squares Mean
851200|NCT02260986|Secondary|Change From Baseline in Patient Oriented Eczema Measure (POEM) to Week 52|The POEM was a 7-item questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease) (high score indicative of poor quality of life [QOL]).|Baseline to Week 52|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with available data for this endpoint.||units on a scale||Standard Error|Least Squares Mean
851201|NCT02260986|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 52|The DLQI was a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life (QOL). The 10 questions assessed QOL over the past week, with an overall scoring of 0 (absent disease) to 30 (severe disease); a high score was indicative of a poor QOL.|Baseline to Week 52|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with available data for this endpoint.||units on a scale||Standard Error|Least Squares Mean
851202|NCT02260986|Secondary|Percent Change From Baseline in Global Individual Signs Score (GISS) to Week 52|Individual components of the AD lesions (erythema, infiltration/ papulation, excoriations, and lichenification) were rated globally (each assessed for the whole body, not by anatomical region) on a 4-point scale (0= none, 1= mild, 2= moderate and 3= severe) using the EASI severity grading criteria. Total score ranges from 0 (absent disease) to 12 (severe disease).|Baseline to Week 52|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with available data for this endpoint.||percent change||Standard Error|Least Squares Mean
851203|NCT02260986|Secondary|Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Score to Week 52|SCORAD was a clinical tool for assessing the severity of AD developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index). Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology (Basel) 186 (1): 23–31. 1993. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) were assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease).|Baseline to Week 52|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with available data for this endpoint.||percent change||Standard Error|Least Squares Mean
851204|NCT02260986|Secondary|Change From Baseline in Percent Body Surface Area (BSA) Affected by Atopic Dermatitis to Week 52|BSA affected by AD was assessed for each section of the body (the possible highest score for each region was: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]). It was reported as a percentage of all major body sections combined.|Baseline to Week 52|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with available data for this endpoint.||Percentage of BSA||Standard Error|Least Squares Mean
851205|NCT02260986|Secondary|Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score to Week 52|The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.|Baseline to Week 52|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with available data for this endpoint.||percent change||Standard Error|Least Squares Mean
851206|NCT02260986|Secondary|Percent Change From Baseline in Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score to Week 2|Pruritus NRS was an assessment tool that was used to report the intensity of a participant’s pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 – 10 [0 = no itch; 10 = worst itch imaginable]).|Baseline to Week 2|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).||percent change||Standard Error|Least Squares Mean
851207|NCT02260986|Secondary|Proportion of Topical Atopic Dermatitis Medication-Free Days Through Week 52|Proportion of topical AD medication-free days through Week 52 was calculated as the number of days that a participant used neither topical corticosteroid (TCS)/ topical calcineurin inhibitors (TCI) nor system rescue therapy divided by the study days of each period.|Baseline to Week 52|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).||days||Standard Deviation|Mean
851208|NCT02260986|Secondary|Percent Change From Baseline in Total Global Individual Signs Score (GISS) to Week 16|Individual components of the AD lesions (erythema, infiltration/ papulation, excoriations, and lichenification) were rated globally (each assessed for the whole body, not by anatomical region) on a 4-point scale (0= none, 1= mild, 2= moderate and 3= severe) using the EASI severity grading criteria. Total score ranges from 0 (absent disease) to 12 (severe disease).|Baseline to Week 16|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).||percent change||Standard Error|Least Squares Mean
851209|NCT02260986|Secondary|Change From Baseline in Hospital Anxiety Depression Scale (HADS) to Week 16|HADS is a fourteen item scale. Seven of the items relate to anxiety and seven items relate to depression. Each item on the questionnaire scored from 0 (minimum score) - 3 (maximum score) and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression. Cut-offs for identifying psychiatric distress has been reported as 7 to 8 for possible presence, 10 to 11 for probable presence, and 14 to 15 for severe anxiety or depression.|Baseline to Week 16|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).||units on a scale||Standard Error|Least Squares Mean
851210|NCT02260986|Secondary|Change From Baseline in Patient Oriented Eczema Measure (POEM) to Week 16|The POEM was a 7-item questionnaire that assessed disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease) (high score indicative of poor quality of life [QOL]).|Baseline to Week 16|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).||units on a scale||Standard Error|Least Squares Mean
851211|NCT02260986|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 16|The DLQI was a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life (QOL). The 10 questions assessed QOL over the past week, with an overall scoring of 0 (absent disease) to 30 (severe disease); a high score was indicative of a poor QOL.|Baseline to Week 16|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).||units on a scale||Standard Error|Least Squares Mean
851212|NCT02260986|Secondary|Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Score to Week 16|SCORAD was a clinical tool for assessing the severity of AD developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index). Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology (Basel) 186 (1): 23–31. 1993. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) were assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease).|Baseline to Week 16|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).||percent change||Standard Error|Least Squares Mean
851213|NCT02260986|Secondary|Change From Baseline in Percent Body Surface Area (BSA) Affected by Atopic Dermatitis to Week 16|BSA affected by AD was assessed for each section of the body (the possible highest score for each region was: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]). It was reported as a percentage of all major body sections combined.|Baseline to Week 16|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).||Percentage of BSA||Standard Error|Least Squares Mean
851214|NCT02260986|Secondary|Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score to Week 16|The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.|Baseline to Week 16|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).||percent change||Standard Error|Least Squares Mean
851215|NCT02260986|Secondary|Change From Baseline in Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score to Week 16|Pruritus NRS was an assessment tool that was used to report the intensity of a participant’s pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 – 10 [0 = no itch; 10 = worst itch imaginable]).|Baseline to Week 16|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).||units on a scale||Standard Error|Least Squares Mean
851216|NCT02260986|Secondary|Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 2|Pruritus NRS was an assessment tool that was used to report the intensity of a participant’s pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 – 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 2 were reported.|Baseline to Week 2|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with baseline peak pruritus NRS score ≥4.||percentage of participants|||Number
851217|NCT02260986|Secondary|Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 4|Pruritus NRS was an assessment tool that was used to report the intensity of a participant’s pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 – 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 4 were reported.|Baseline to Week 4|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with baseline peak pruritus NRS score ≥4.||percentage of participants|||Number
851218|NCT02260986|Secondary|Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 24|Pruritus NRS was an assessment tool that was used to report the intensity of a participant’s pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 – 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 24 were reported.|Baseline to Week 24|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with baseline peak pruritus NRS score ≥4.||percentage of participants|||Number
851219|NCT02260986|Secondary|Percentage of Participants With Improvement (Reduction ≥3 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 52|Pruritus NRS was an assessment tool that was used to report the intensity of a participant’s pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 – 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥3 points from baseline in weekly average of peak daily pruritus NRS score at Week 52 were reported.|Baseline to Week 52|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with baseline peak pruritus NRS score ≥3.||percentage of participants|||Number
851220|NCT02260986|Secondary|Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 52|Pruritus NRS was an assessment tool that was used to report the intensity of a participant’s pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 – 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 52 were reported.|Baseline to Week 52|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with baseline peak pruritus NRS score ≥4.||percentage of participants|||Number
851221|NCT02260986|Secondary|Percent Change From Baseline in Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score to Week 16|Pruritus NRS was an assessment tool that was used to report the intensity of a participant’s pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 – 10 [0 = no itch; 10 = worst itch imaginable]).|Baseline to Week 16|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).||percent change||Standard Error|Least Squares Mean
851222|NCT02260986|Secondary|Percentage of Participants With Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) at Week 52|The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-75 responders were the participants who achieved ≥75% overall improvement in EASI score from baseline to Week 52.|Baseline to Week 52|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with available data for this endpoint.||percentage of participants|||Number
851223|NCT02260986|Secondary|Percentage of Participants With Investigator’s Global Assessment (IGA) Score of “0” or “1” and Reduction From Baseline of ≥2 Points at Week 52|IGA is an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response is an IGA score of 0 (clear) or 1 (almost clear). Participants with IGA score of “0” or “1” and a reduction from baseline of ≥2 points at Week 52 were reported.|Baseline to Week 52|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with available data for this endpoint.||percentage of participants|||Number
851224|NCT02260986|Secondary|Percentage of Participants With Improvement (Reduction ≥3 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16|Pruritus NRS was an assessment tool that was used to report the intensity of a participant’s pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 – 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥3 points from baseline in weekly average of peak daily pruritus NRS score at Week 16 were reported.|Baseline to Week 16|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with baseline peak pruritus NRS score ≥3.||percentage of participants|||Number
851225|NCT02260986|Secondary|Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16|Pruritus NRS was an assessment tool that was used to report the intensity of a participant’s pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 – 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 16 were reported.|Baseline to Week 16|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with baseline peak pruritus NRS score ≥4.||percentage of participants|||Number
851226|NCT02260986|Secondary|Percentage of Participants With Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) at Week 16|The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-75 responders were the participants who achieved ≥75% overall improvement in EASI score from baseline to Week 16.|Baseline to Week 16|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).||percentage of participants|||Number
851227|NCT02260986|Primary|Percentage of Participants With Investigator’s Global Assessment (IGA) Score of “0” or “1” and Reduction From Baseline of ≥2 Points at Week 16|"IGA is an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response is an IGA score of 0 (clear) or 1 (almost clear). Participants with IGA score 0 or 1 and a reduction from baseline of ≥2 points at Week 16 were reported."|Baseline to Week 16|All efficacy analyses were performed on the Full Analysis Set (FAS), which included all randomized participants. Efficacy analyses were based on the treatment allocated by interactive voice response system/ interactive web response system (IVRS/IWRS) at randomization (as randomized).||percentage of participants|||Number
851228|NCT02251990|Other Pre-specified|Percentage of Participants Achieving Sustained Virologic Response 4 Weeks After the End of All Study Therapy (SVR4)|Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® AmpliPrep/COBAS® Taqman HCV Test, v2.0, which had a LLOQ of 15 IU/mL. SVR4 was defined as HCV RNA <LLOQ at 4 weeks after the end of all study therapy. As pre-specified in the protocol, the Deferred Treatment Group was not included in this efficacy analysis.|4 weeks after end of all therapy (Study Week 16)|All randomized participants in the Immediate Treatment Group who received at least one dose of study treatment. The Deferred Treatment Group was not included in this efficacy analysis.||percentage of participants||95% Confidence Interval|Number
851229|NCT02251990|Secondary|Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After the End of All Study Therapy (SVR24)|Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® AmpliPrep/COBAS® Taqman HCV Test, v2.0, which had a LLOQ of 15 IU/mL. SVR24 was defined as HCV RNA <LLOQ at 24 weeks after the end of all study therapy. As pre-specified in the protocol, the Deferred Treatment Group was not included in the secondary efficacy analysis.|24 weeks after end of all therapy (Study Week 36)|All randomized participants in the Immediate Treatment Group who received at least one dose of study treatment. The Deferred Treatment Group was not included in the secondary efficacy analysis.||percentage of participants||95% Confidence Interval|Number
851230|NCT02251990|Primary|Percentage of Participants That Discontinued From Study Therapy Due to AEs During the DB Treatment Period|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that is temporally associated with the use of the Sponsor’s product, is also an AE. A participant could discontinue from treatment but continue to participate in the study as long as consent was not withdrawn. The primary safety analysis compared the safety data of the Immediate Treatment Group during the active treatment period to those of the Deferred Treatment Group during the placebo treatment period.|DB Treatment period (up to 12 weeks)|All randomized participants who received at least one dose of study treatment during the double-blind treatment period.||percentage of participants|||Number
851231|NCT02251990|Primary|Percentage of Participants Experiencing at Least One Adverse Event (AE) During the DB Treatment Period and First 14 Follow-up Days|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that is temporally associated with the use of the Sponsor’s product, is also an AE. The primary safety analysis compared the safety data of the Immediate Treatment Group during the active treatment period to those of the Deferred Treatment Group during the placebo treatment period.|DB Treatment period plus first 14 follow-up days (up to 14 weeks)|All randomized participants who received at least one dose of study treatment during the double-blind treatment period.||percentage of participants|||Number
851232|NCT02251990|Primary|Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After the End of All Study Therapy (SVR12)|Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS® AmpliPrep/COBAS® Taqman HCV Test, v2.0, which had a lower limit of quantification (LLOQ) of 15 IU/mL. SVR12 was defined as HCV RNA below the lower limit of detection (<LLOQ) at 12 weeks after the end of all study therapy. As pre-specified in the protocol, the Deferred Treatment Group was not included in the primary efficacy analysis.|12 weeks after end of all therapy (Study Week 24)|All randomized participants in the Immediate Treatment Group who received at least one dose of study treatment. The Deferred Treatment Group was not included in the primary efficacy analysis.||percentage of participants||97.5% Confidence Interval|Number
851280|NCT02119650|Secondary|Participants With Treatment-emergent Adverse Events (TEAEs)|A treatment-emergent AE was defined as an event occurring (or worsening of any pre-existing) after exposure to at least 1 dose of study drug. A treatment-related AE was defined as an event with a definite, probable, or possible causality to study medication. A serious AE is an event resulting in death, hospitalization, persistent or significant disability/incapacity, or is life threatening, a congenital anomaly/birth defect or requires medical or surgical intervention to prevent 1 of the outcomes above. The intensity of an AE was graded according to the National Cancer Institute common terminology criteria for adverse events (NCI-CTCAE) version 4.03: Grade 1 (Mild); Grade 2 (Moderate); Grade 3 (Severe); Grade 4 (life-threatening).|Baseline through approximately 30 days post treatment discontinuation; up to 16 months or to the data cutoff 11FEB2016.|The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.||Participants|||Count of Participants
851281|NCT02119650|Secondary|Duration of Response|For objective responders, the duration of response is defined as the difference of the end of response and the start of response. The start of a response was the first visit where the subject achieves PR or better based on RECIST v1.1 criteria. The end of response was the first visit after PD based on RECIST v1.1 criteria.|From the start of response to the end of response; up to 16 months or to the data cutoff 11FEB2016.|The intent-to-treat (ITT) population consisted of participants that were randomized in the study.||weeks||80% Confidence Interval|Median
851282|NCT02119650|Secondary|Objective Response Rate (ORR)|Objective response rate determined by radiographic disease assessments per RECIST (v1.1), by investigator assessment and was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) by Response Evaluation Criteria in Solid Tumours (RECIST) at any post baseline visit. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI) : Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions with no worsening of non-target lesions and no new lesions; Overall Response (OR) = CR + PR.|Baseline through end of study; up to 16 months or to the data cutoff 11FEB2016.|The intent-to-treat (ITT) population consisted of participants that were randomized in the study.||Participants|||Count of Participants
851283|NCT02119650|Secondary|Progression-free Survival (PFS)|PFS is defined as the time from randomization until the earliest date of disease progression determined by investigator assessment of objective radiographic disease assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause if sooner. Progressive Disease (PD) is defined using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum Longest Diameter (LD) recorded since the treatment started or the appearance of one or more new lesions, unequivocal progression of non-target lesions or increase in disease burden for subjects with only nonmeasurable disease.|Randomization to disease progression, or death due to any cause if sooner; up to 16 months or to the data cutoff 11FEB2016.|The intent-to-treat (ITT) population consisted of participants that were randomized in the study.||Months||95% Confidence Interval|Median
851284|NCT02119650|Primary|Overall Survival (OS)|Overall survival is defined as the time from randomization to death due to any cause. Participants without death observed at the time of the analysis were censored at last date known to be alive. The median overall survival time was estimated using the Kaplan-Meier method. Overall survival was compared between treatment groups using log-rank test.|Randomization until death due to any cause; up to 16 months or data cutoff 11FEB2016.|The intent-to-treat (ITT) population consisted of participants that were randomized in the study.||months||80% Confidence Interval|Median
851305|NCT02075255|Secondary|Inspiratory Capacity|Change from baseline in inspiratory capacity|From baseline to Week 28|Global Sputum Substudy||Liter||Standard Deviation|Mean
851306|NCT02075255|Secondary|Functional Residual Capacity|Change from baseline in functional residual capacity|From baseline to Week 28|Global Sputum Substudy||Liter||Standard Deviation|Mean
851307|NCT02075255|Secondary|Vital Capacity|Change from baseline in vital capacity|From baseline to Week 28|Global Sputum Substudy||Liter||Standard Deviation|Mean
851308|NCT02075255|Secondary|Residual Volume|Change from baseline in residual volume|From baseline to Week 28|Global Sputum Substudy||Liter||Standard Deviation|Mean
851309|NCT02075255|Secondary|Total Lung Capacity|Change from baseline in total lung capacity|From baseline to Week 28|Global Sputum Substudy||Liter||Standard Deviation|Mean
851310|NCT02075255|Secondary|Percent Change From Baseline in Blood Eosinophil Counts|Percent change from baseline in blood eosinophil counts at week 28|Change from baseline at Week 28|Full analysis set. Number of participants analyzed contains number of participants who had value at Week 28.||percent change||Standard Deviation|Mean
851311|NCT02075255|Secondary|Anti-drug Antibody Response|Number and percentage of patients in different ADA response categories|From baseline to follow-up Week 36|Safety analysis set||Participants|||Count of Participants
851312|NCT02075255|Secondary|Serum Concentration of Benralizumab|Pre-dose serum concentrations at each visit|Pre-first dose to Week 36|PK analysis set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
851313|NCT02075255|Secondary|Extent of Exposure|Duration of exposure from first dose date to last dose date.|From first dose to Week 24|Safety analysis set||Days||Standard Deviation|Mean
851314|NCT02075255|Secondary|AQLQ(s)+12 Responders (Improvement) at Week 28|"AQLQ(S)+12 overall score is defined as the average of all 32 questions in the AQLQ(S)+12 questionnaire. Improvement is defined as AQLQ(S)+12 (End of treatment - baseline)>=0.5. No change is defined as AQLQ(S)+12 (End of treatment - baseline) >-0.5 and <0.5. Deterioration is defined as AQLQ(S)+12 (End of treatment - baseline) <= -0.5.
Baseline is defined as the last AQLQ(S)+12 score prior to randomisation. End of treatment is defined as week 28. Patients with missing or non-evaluable score at week 28 are considered as non-responder."|Week 28|Full analysis set||Participants|||Number
851315|NCT02075255|Secondary|Change From Baseline at Week 28 in AQLQ(S)+12 (Overall)|AQLQ(S)+12 overall score is defined as the average of all 32 questions in the AQLQ(S)+12 questionnaire. AQLQ(S)+12 is a 7-point scale questionnaire, ranging from 7 (no impairment) to 1 (severe impairment). Total or domain score change of >=0.5 are considered clinically meaningful.|Change from baseline at week 28|Full analysis set. Number of participants analyzed contains number of participants who had value at Week 28.||Scores on a scale||Standard Deviation|Mean
851316|NCT02075255|Secondary|ACQ-6 Responders (Improvement) at Week 28|"Improvement is defined as ACQ-6 (End of treatment - baseline) <= -0.5. No change is defined as ACQ-6 (End of treatment - baseline) >-0.5 and <0.5. Deterioration is defined as ACQ-6 (End of treatment - baseline) >= 0.5. ACQ-6 score is defined as the average of the first 6 items of the ACQ questionnaire on symptoms, activity limitations and rescue medication.Scores range from 0 (totally controlled) to 6 (severely uncontrolled).
Baseline is defined as the last non-missing value prior to randomisation. End of treatment is defined as week 28. Patients with missing or non-evaluable ACQ-6 at week 28 are considered non-responder."|Week 28|Full analysis set||Participants|||Number
851317|NCT02075255|Secondary|Change From Baseline to Week 28 in ACQ-6|ACQ-6 contains one bronchodilator question and 5 symptom questions. Questions are rated from 0 (totally controlled) to 6 (severely uncontrolled). Mean ACQ-6 score is the average of the responses. Mean scores of <=0.75 indicates well-controlled asthma, scores between 0.75 to <=1.5 indicate partly controlled asthma, and >1.5 indicates not well controlled asthma.|Change from baseline at week 28|Full analysis set. Number of participants analyzed contains number of participants who had value at Week 28.||Scores on a scale||Standard Deviation|Mean
851318|NCT02075255|Secondary|Change From Baseline to Week 28 in the Proportion of Nights With Awakening Due to Asthma Requiring Rescue Medication|Baseline is defined as the proportion of nights from the evening of study day -14 to the morning of study day 1.Each timepoint is calculated as bi-weekly proportions based on daily diary data. If more than 50% of data are missing in a 14 day period then this will be considered as missing.Proportion of nights with noctural awakenings is defined as the number of nights with awakenings due to asthma and requiring rescue medication divided by number of nights with data.|Change from baseline at week 28|Full analysis set. Number of participants analyzed contains number of participants who had value at Week 28.||Proportion||Standard Deviation|Mean
851319|NCT02075255|Secondary|Change From Baseline to Week 28 in Home Lung Function (Evening Peak Expiratory Flow)|Evening peak expiratory flow change from baseline to week 28. Baseline is defined as the average of data collected from the evening of study day -14 to the morning of study day 1. Each timepoint is calculated as bi-weekly means based on daily diary data|Change from baseline at week 28|Full analysis set. Number of participants analyzed contains number of participants who had value at Week 28.||Liter/min||Standard Deviation|Mean
851320|NCT02075255|Secondary|Change From Baseline to Week 28 in Home Lung Function (Morning Peak Expiratory Flow)|Morning peak expiratory flow change from baseline to week 28. Baseline is defined as the average of data collected from the evening of study day -14 to the morning of study day 1. Each timepoint is calculated as bi-weekly means based on daily diary data.|Change from baseline at week 28|Full analysis set. Number of participants analyzed contains number of participants who had value at Week 28.||Liter/min||Standard Deviation|Mean
851321|NCT02075255|Secondary|Change From Baseline to Week 28 in Rescue Medication Use|Baseline is defined as the average of data collected from the evening of study day -14 to the morning of study day 1. Each timepoint is calculated as bi-weekly means based on daily diary data. If more than 50% of scores are missing in a 14 day period then this will be considered as missing. The number of inhalations (puffs) per day will be calculated as follows: Number of night inhaler puffs + 2 x [number of night nebulizer times] + number of day inhaler puffs + 2 x [number of day nebulizer times].|Change from baseline at week 28|Full analysis set. Number of participants analyzed contains number of participants who had value at Week 28.||number of puffs per day||Standard Deviation|Mean
851322|NCT02075255|Secondary|Change From Baseline to Week 28 in Asthma Symptom Scores (Nighttime)|Asthma symptoms during night time are recorded by the patient in the asthma daily diary. Symptom score values are from 0 (No asthma symptom) to 3 (unable to sleep because of asthma, or unable to do normal activities due to asthma). Lower score (0) is indicating better asthma symptom, while higher score (3) is indicating worse asthma symptom. Baseline is defined as the average of data collected from the evening of study day -14 to the morning of study day 1. Each time point is calculated as bi-weekly means based on daily diary data. If more than 50% of scores are missing in a 14 day period then this is considered as missing. Symptom score lower is better.|Change from baseline at week 28|Full analysis set. Number of participants analyzed contains number of participants who had value at Week 28.||Scores on a scale||Standard Deviation|Mean
851323|NCT02075255|Secondary|Change From Baseline to Week 28 in Asthma Symptom Scores (Daytime)|Asthma symptoms during daytime are recorded by the patient in the asthma daily diary. Symptom score values are from 0 (No asthma symptom) to 3 (unable to sleep because of asthma, or unable to do normal activities due to asthma). Lower score (0) is indicating better asthma symptom, while higher score (3) is indicating worse asthma symptom. Baseline is defined as the average of data collected from the evening of study day -14 to the morning of study day 1. Each time point is calculated as bi-weekly means based on daily diary data. If more than 50% of scores are missing in a 14 day period then this is considered as missing. Symptom score lower is better.|Change from baseline at week 28|Full analysis set. Number of participants analyzed contains number of participants who had value at Week 28.||Scores on a scale||Standard Deviation|Mean
851324|NCT02075255|Secondary|Change From Baseline to Week 28 in Asthma Symptom Scores (Total)|Asthma symptoms during night time and daytime are recorded by the patient in the asthma daily diary. Symptom score values are from 0 (No asthma symptom) to 3 (unable to sleep because of asthma, or unable to do normal activities due to asthma), and total asthma symptom score is the sum of the daytime and night time score (0 to 6). Lower score (0) is indicating better asthma symptom, while higher score (6) is indicating worse asthma symptom. Baseline is defined as the average of data collected from the evening of study day -14 to the morning of study day 1. Each time point is calculated as bi-weekly means based on daily diary data. If more than 50% of scores are missing in a 14 day period then this is considered as missing. Symptom score lower is better.|Change from baseline at week 28|Full analysis set. Number of participants analyzed contains number of participants who had value at Week 28.||Scores on a scale||Standard Deviation|Mean
851325|NCT02075255|Secondary|Change From Baseline to Week 28 in Pre-bronchodilator FEV1|Baseline is defined as the last non-missing value prior to the first dose of study treatment. Change from baseline to Week 28 in two treatment groups is compared to placebo group.|Change from baseline at week 28|Full analysis set. Number of participants analyzed contains number of participants who had value at Week 28.||Liter||Standard Deviation|Mean
851326|NCT02075255|Secondary|Number of Days in Hospital Due to Asthma|Number of days in hospital due to asthma, if none, 0 day is considered|The time from randomisation to the date of week 28 visit (end of treatment) or last contact if the patient is lost to follow up|Full analysis set||Days||Standard Deviation|Mean
851327|NCT02075255|Secondary|The Annualized Rate of Asthma Exacerbations That Are Associated With an Emergency Room Visit or a Hospitalization|The annualized exacerbation rate is based on unadjudicated exacerbation reported by the investigator that are associated with an emergency room visit or a hospitalization adjusted by the time of follow-up.|The time from randomisation to the date of week 28 visit (end of treatment) or last contact if the patient is lost to follow up|Full analysis set||events/year||95% Confidence Interval|Least Squares Mean
851328|NCT02075255|Secondary|The Annualized Rate of Asthma Exacerbation|The annualized exacerbation rate is based on unadjudicated exacerbation reported by the investigator adjusted by the time of follow-up.|The time from randomisation to the date of week 28 visit (end of treatment) or last contact if the patient is lost to follow up|Full analysis set||events/year||95% Confidence Interval|Least Squares Mean
851329|NCT02075255|Secondary|Time to the First Asthma Exacerbation Requiring Hospitalization or ER Visit|Time to the first exacerbation requiring hospitalization or ER visit post randomisation|The time from randomisation to the date of first asthma exacerbation associated with hospitalization or ER over 28 weeks.|Full analysis set||Days||95% Confidence Interval|Median
851330|NCT02075255|Secondary|Time to the First Asthma Exacerbation|Time to the first occurrence of asthma exacerbation post randomisation|The time from randomisation to the date of first asthma exacerbation over 28 weeks|Full analysis set||Days||95% Confidence Interval|Median
851331|NCT02075255|Secondary|Number and Percentage of Patients With ≥1 Asthma Exacerbation|Number and percentage of patients with at least one post randomisation asthma exacerbation.|Immediately following the randomisation through Study Week 28|Full analysis set||Participants|||Count of Participants
851332|NCT02075255|Secondary|The Proportion of Patients With Average Final OCS Dose ≤5.0 mg Daily at Visit 14, While Maintaining Asthma Control|Final OCS dose is the dose at Week 28. If a patient discontinues from the study during a given dose reduction period, or the patient experiences an exacerbation between Weeks 24 and 28 or immediately before discontinuation, then the final OCS dose will be 1 dose level higher than that which directly preceded the event.|Week 28|Full analysis set||Participants|||Number
851333|NCT02075255|Secondary|The Proportion of Patients With ≤5.0 mg Reduction on Daily OCS Dose at Visit 14 Compared With Baseline Dose at Visit 6, While Maintaining Asthma Control.|Baseline OCS dose is the dose upon which the patient is stabilised at randomisation (Week 0). Final OCS dose is the dose at Week 28. If a patient discontinues from the study during a given dose reduction period, or the patient experiences an exacerbation between Weeks 24 and 28 or immediately before discontinuation, then the final OCS dose will be 1 dose level higher than that which directly preceded the event.|Week 28|Full analysis set||Participants|||Number
851334|NCT02075255|Secondary|The Proportion of Eligible Patients With ≥100% Reduction in Average Daily OCS Dose at Visit 14 Compared With Baseline Dose at Visit 6, While Maintaining Asthma Control|Baseline OCS dose is the dose upon which the patient is stabilised at randomisation (Week 0). Final OCS dose is the dose at Week 28. The percentage reduction from baseline is defined as: {(Baseline dose–final dose)/baseline dose}*100%. If a patient discontinues from the study during a given dose reduction period, or the patient experiences an exacerbation between Weeks 24 and 28 or immediately before discontinuation, then the final OCS dose will be 1 dose level higher than that which directly preceded the event.|Week 28|Full analysis set, eligible for 100% reduction (ie, patients with baseline OCS dose <= 12.5 mg)||Participants|||Number
851335|NCT02075255|Secondary|The Percentage of Patients With ≥50% Reduction in Average Daily OCS Dose at Visit 14 Compared With Baseline Dose at Visit 6, While Maintaining Asthma Control|Baseline OCS dose is the dose upon which the patient is stabilised at randomisation (Week 0). Final OCS dose is the dose at Week 28. The percentage reduction from baseline is defined as: {(Baseline dose–final dose)/baseline dose}*100%. If a patient discontinues from the study during a given dose reduction period, or the patient experiences an exacerbation between Weeks 24 and 28 or immediately before discontinuation, then the final OCS dose will be 1 dose level higher than that which directly preceded the event.|Week 28|Full analysis set||Participants|||Count of Participants
851336|NCT02075255|Secondary|Percentage Reduction in Final OCS Dose Compared With Baseline While Maintaining Asthma Control for Patients With Baseline Eosinophils >=300/uL|Baseline OCS dose is the dose upon which the patient is stabilised at randomisation (Week 0). Final OCS dose is the dose at Week 28. The percentage reduction from baseline is defined as: {(Baseline dose–final dose)/baseline dose}*100%. If a patient discontinues from the study during a given dose reduction period, or the patient experiences an exacerbation between Weeks 24 and 28 or immediately before discontinuation, then the final OCS dose will be 1 dose level higher than that which directly preceded the event.|Week 28|Full analysis set, baseline blood eosinophil >=300/uL||Percent||95% Confidence Interval|Median
851337|NCT02075255|Secondary|Number and Percentage of Patients in Different Categories of Percent Reduction From Baseline in Final OCS Dose While Maintaining Asthma Control|Number and percentage of patients in different categories of percent reduction from baseline in final OCS dose.|Week 28|Full analysis set||Participants|||Count of Participants
851338|NCT02075255|Primary|Percentage Reduction in Final OCS Dose Compared With Baseline While Maintaining Asthma Control|Baseline OCS dose is the dose upon which the patient is stabilised at randomisation (Week 0). Final OCS dose is the dose at Week 28. The percentage reduction from baseline is defined as: {(Baseline dose–final dose)/baseline dose}*100%. If a patient discontinues from the study during a given dose reduction period, or the patient experiences an exacerbation between Weeks 24 and 28 or immediately before discontinuation, then the final OCS dose will be 1 dose level higher than that which directly preceded the event.|Week 28|Full analysis set||Percent||95% Confidence Interval|Median
851341|NCT02015481|Secondary|SWAL-QOL, Swallowing Quality of Life Questionnaire|Summary of Quality of Life in Swallowing Disorders total symptom score results over time, change from baseline at weeks 12 and 24 This is a 100 point scale. The higher the number the better the quality of life.|28 weeks|||percentage change from baseline||Standard Deviation|Mean
851342|NCT02015481|Secondary|Videofluoroscopy (VFS) Score|Penetration aspiration score results assessed by VFS comparing baseline, prior to treatment, to week 24. This is an 8 point scale. The higher the number the greater the risk of aspiration. The result reported is the difference from the baseline scores.|24 Weeks|11 patients had valid baseline data and week 24 data||Points on an 8 point scale||Standard Deviation|Mean
851343|NCT02015481|Secondary|Drinking Test Score|Change from baseline in ice water drinking time, in seconds, at week 24. Times greater than 8 seconds to complete the drinking test are considered abnormal.|24 weeks|22 patients had data available for analysis at week 24||percentage change from baseline||Standard Deviation|Mean
851344|NCT02015481|Primary|Safety Lab Evaluations|Change from baseline in safety labs including hematology, coagulation, chemistry, renal function, and liver function tests at week 24 .|24 weeks|24 patients were available for analysis at week 24. Not all patients had all labs performed. Missing data accounts for the differing number of patients with specific lab values.||percentage change from baseline||Standard Deviation|Mean
851433|NCT01916941|Primary|Number of Standard Alcoholic Drinks Consumed Per Week (Drinks Per Week)||from 2-4 weeks and from 4-6 weeks|||drinks per week||Standard Deviation|Mean
851603|NCT01602016|Secondary|Improved Stereotyped Behavior and Improved Social Skills|Stereotyped behavior (as measured by the OACIS (not at 6 weeks), ASQ, RBS-R, and ABC) and social skills (as measured by the Vineland (not at 6 weeks), ASQ, and SRS) will be the secondary outcomes.|(baseline, 6, and 12 weeks)|No data because no patients were analyzed.|||||
851465|NCT01762943|Secondary|Change in Inventory of Depression and Anxiety Symptoms (IDAS) Dysphoria Score|"The IDAS Dysphoria Scale consists of 10 items and uses a 5-point Likert-type scale, ranging from 1 to 5 with 1 indicating not at all and 5 indicating extremely. As such, the range of possible scores is 10 to 50. The Dysphoria scale includes items assessing feelings of depression, inadequacy, psychomotor agitation, guilt, discouragement, anhedonia, poor concentration, difficulty with decision-making, psychomotor retardation, and worry. Higher scores indicate greater dysphoria."|Assessed at baseline and post-treatment|Of the 36 women who enrolled in the study, 6 (4 PPD, 2 controls) were withdrawn prior to the second fMRI session. For the purpose of this group x time analysis, their data have been excluded. All 30 subjects who completed the protocol were included in this analysis.||units on a scale||Standard Deviation|Mean
851466|NCT01762943|Primary|Blood-oxygen-level-dependent (BOLD) Response During Functional Magnetic Resonance Imaging (fMRI) z Statistic|fMRI data collected during a Monetary Incentive Delay (MID) Task. For both tasks, the BOLD response was examined within the nucleus accumbens. The contrast of interest was win versus non-win outcomes in the MID Task. The z statistic reported represents the maximum contrast between win versus non-win outcomes during the MID task in the nucleus accumbens, averaged across the participants in each group. Individual z scores were generated using the Oxford Centre for Functional Magnetic Resonance Imaging of the Brain (FMRIB) software library (FSL), which is a library of brain imaging analysis tools for fMRI.|baseline and hormone withdrawal|Of the 36 women who enrolled in the study, 6 were withdrawn prior to the second fMRI session. For the purpose of this group x time analysis, their data have been excluded. In addition, one participant had significant motion artifact (>4mm) during one run of the MID, and as such, her data were excluded from the analyses.||z score||Standard Deviation|Mean
851467|NCT01751412|Secondary|6-Month Progression-Free Survival|The number of participants surviving without disease progression six months after the start of treatment|6 Months|||Participants|||Count of Participants
851468|NCT01751412|Secondary|6-Month Overall Survival|The number of participants surviving six months after starting treatment|6 Months|||Participants|||Count of Participants
851469|NCT01751412|Secondary|Late Toxicities|Late toxicities including clinical and sub-clinical heart disease, pulmonary fibrosis, esophageal stricture, myelopathy, thyroid dysfunction and secondary cancers.|5 years|The trial was terminated before the study endpoint was met. The data is not available for analysis.|||||
851470|NCT01751412|Secondary|Acute Toxicities|Acute toxicities including pericarditis, pneumonitis, Lhermitte's, dermatitis, mucositis, esophagitis, leukopenia, xerostomia, and thrombocytopenia. Data is shown as the number of participants that experienced the given toxicities.|90 Days|||participants|||Number
851471|NCT01751412|Secondary|Local Control|The number of participants who maintained local control for the duration of their followup. Local control is defined as the lack of disease progression. Progression is the increased growth of cancer cells or the spread of the cancer cells to another location within the body.|2 years|||Participants|||Count of Participants
851472|NCT01751412|Primary|Radiation Dose to the Normal Tissue of the Lungs|The percentage of the lung volume which received radiation does of 20 Gray (Gy) or more. The lung volume percentages for the 12 participants were averaged and presented separately for the left and right lungs.|6 Weeks|||Percentage of Lung Volume||Full Range|Mean
851473|NCT01751412|Primary|Mean Radiation Dose to Normal Heart Tissue|The mean radiation dose to the heart in Gy RBE (Gray relative biological effectiveness).|6 weeks|||Gy(RBE)||Full Range|Mean
851554|NCT01658228|Other Pre-specified|FC-SRT||Week 0 Screening||||||
851555|NCT01658228|Other Pre-specified|WMS-R Logical Memory||Week 0 Screening||||||
851556|NCT01658228|Other Pre-specified|MRI Scan|Images will be obtained using a GE Signa 3 Tesla whole body scanner. T1-weighted sagittal fspgr and T2 FLAIR are the pulse sequences used in order to obtain the MRI images.|Within 1 month of Screen Visit (Week 0)||||||
851557|NCT01658228|Other Pre-specified|University of Pennsylvania Smell Identification Test (UPSIT)|"The subject will scratch and sniff 40 common odorants embedded in microcapsules on a separate page. The subject will choose the answer from a 4-item multiple choice list. Scores will range from 0-40."|Screen (Week 0)||||||
851558|NCT01658228|Other Pre-specified|Apolipoprotein E Genotype|Using a standard protocol, DNA is amplified by the polymerase chase reaction (PCR). The genotypes are determined blind to subject status (patient or control) by the sizes of DNA fragments present.|Week 2||||||
851559|NCT01658228|Other Pre-specified|Boston Naming||Screen (Week 0), Week 16, Week 40, Week 64, Week 78||||||
851560|NCT01658228|Other Pre-specified|COWAT||Screen (Week 0), Week 16, Week 40, Week 64, Week 78||||||
851561|NCT01658228|Other Pre-specified|WAIS-III Block Design Subtest||Screen (Week 0), Week 16, Week 40, Week 64, Week 78||||||
851562|NCT01658228|Other Pre-specified|WAIS-III Digit Symbol Subtest||Screen (Week 0), Week 16, Week 40, Week 64, Week 78||||||
851563|NCT01658228|Other Pre-specified|Stroop||Screen (Week 0), Week 16, Week 40, Week 64, Week 78||||||
851564|NCT01658228|Other Pre-specified|Trails A and B|Parts A and B are composed of 25 circles. Patients are asked to scan the entire page and identify the next number or letter in a sequence.|Screen (Week 0), Week 16, Week 40, Week 64, Week 78||||||
851565|NCT01658228|Other Pre-specified|WMS-III Visual Reproduction Subtest||Screen (Week 0), Week 16, Week 40, Week 64, Week 78||||||
851566|NCT01658228|Secondary|Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog)|The modified ADAS-Cog is a cognitive battery that assesses learning, memory, language production, language comprehension, constructional praxis, ideational praxis, and orientation. Subjects' scores represent the total number of errors made throughout the various tasks. The total number of possible errors is between 0-85.|Week 16|||number of errors on a scale from 0-85||Standard Deviation|Mean
851567|NCT01658228|Primary|Selective Reminding Test (SRT) Delayed Recall|The 12-item, 6-trial SRT is a memory measure used to assess verbal list learning and memory. The total number of words learned over six trials (total immediate recall) and delayed recall (after a 15-minute delay) was obtained.|Week 16|||Words||Standard Deviation|Mean
851568|NCT01658228|Primary|Selective Reminding Test (SRT) Total Recall|The 12-item, 6-trial SRT is a memory measure used to assess verbal list learning and memory. The total number of words learned over six trials (total immediate recall) was obtained.|Week 16|||Words||Standard Deviation|Mean
851604|NCT01602016|Primary|Language Improvement|Language (measured by the receptive and expressive CELF language index, and preschool language scale (PLS), as needed) will be the primary outcome for the study. Both preliminary studies have suggested that the folinic acid intervention will be associated with receptive and expressive language improvements.|(baseline and 12 weeks )|The study sponsor (UAMS) was unable to completely monitor the study or resolve outstanding queries. The study data cannot be fully validated by the sponsor. The study was placed on Full Clinical Hold by the FDA and terminated by the sponsor as a result of investigator non-compliance.|||||
851619|NCT01590394|Primary|Large Plastic Biliary Stents Will Have a Longer Patency Time Than Conventionally Used 10 Fr Stents in Subjects as Compared to Well-known Published Historical Control Data.||6 months|Data were not analyzed, because there were too few subjects to make the outcome measure meaningful. Principal investigator retired before any analysis could be performed.|||||
851725|NCT01305941|Secondary|Functional Assessment Cancer Therapy- Breast (FACT-B) From Baseline to 9 Weeks of Treatment to Assess Impact of Everolimus in Combination With Trastuzumab and Vinorelbine on Quality of Life|The FACT-B is a 10-question self-report questionnaire subscale administered with the Functional Assessment of Cancer Therapy- General (FACT-G) which contains concerns relevant to patients with breast cancer. Each question has a value 0-4. For some questions a higher indicates better outcome and others are the opposite. The former are summed as is, the latter are reversed in value before adding, such that each domain ranges from 0 to 4 times the number of questions in the domain, with 0 indicating worst and the highest possible value indicating best outcome. Total scores on the FACT-B subscale range from 0 to 40 with lower scores indicating declining quality of life. The change from baseline is the difference in scores between the baseline and 9 week assessments.|9 weeks|Quality of life was an optional assessment for patients, so results are only reported for subjects who completed questionnaires at each timepoint||units on a scale||Inter-Quartile Range|Median
851726|NCT01305941|Secondary|Functional Assessment of Cancer Therapy- Brain (FACT-Br) Change From Baseline to Assess Impact of Everolimus in Combination With Trastuzumab and Vinorelbine on Quality of Life|The FACT-Br is a 23-question self-report questionnaire subscale administered with the Functional Assessment of Cancer Therapy- General (FACT-G) which contains concerns relevant to patients with brain tumors . Each question has a value 0-4. For some questions a higher indicates better outcome and others are the opposite. The former are summed as is, the latter are reversed in value before adding, such that each domain ranges from 0 to 4 times the number of questions in the domain, with 0 indicating worst and the highest possible value indicating best outcome. Total scores on the FACT-Br subscale range from 0 to 92 with lower scores indicating declining quality of life. The change from baseline is the difference in scores between the baseline and 9 week assessments.|9 weeks|Quality of life was an optional assessment for patients, so results are only reported for subjects who completed questionnaires at each timepoint||units on a scale||Inter-Quartile Range|Median
851727|NCT01305941|Secondary|Overall Survival|Overall survival (OS) after administration of everolimus in combination with trastuzumab and vinorelbine|3 years|||years||95% Confidence Interval|Median
851728|NCT01305941|Secondary|Extracranial Time to Progression|"To evaluate the extracranial time to progression as determined by RECIST 1.1 criteria after administration of everolimus in combination with trastuzumab and vinorelbine.
Progressive Disease (PD) - at least a 20% increase in the sum LD of target lesions, taking as reference the smallest sum of the longest diameter recorded since the treatment started AND an absolute increase in size of at least 5 mm in at least one target lesion OR the appearance of one or more new lesions of at least 6 mm in size."|3 years|Seven subjects were not evaluable for extra-cranial response due to no follow-up disease assessments due to poor clinical status; 12 subjects were excluded since they did not have extra-cranial disease at baseline; 1 subject was non compliant for follow-up scans; and 1 subject was excluded due to intracranial progression prior to extracranial.||months||Full Range|Median
851729|NCT01305941|Secondary|Extracranial Response|"Extracranial response was measured using RECIST 1.1 criteria and defined as the number of subjects achieving CR or PR.
Complete Response (CR) - Disappearance of all target and nontarget lesions Partial Response (PR) - at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum longest diameter AND an absolute decrease of at least 5mm in at least one target lesion.
Stable Disease (SD) - neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum of the longest diameter since the treatment started.
Progressive Disease (PD) - at least a 20% increase in the sum LD of target lesions, taking as reference the smallest sum of the longest diameter recorded since the treatment started AND an absolute increase in size of at least 5 mm in at least one target lesion OR the appearance of one or more new lesions of at least 6 mm in size."|3 years|Seven subjects were not evaluable for extra-cranial response because there was no follow-up disease assessment done due to poor clinical status of subjects. An additional 12 subjects were excluded since they did not have extra-cranial disease at baseline and one additional subject was non compliant for follow-up scans.||Participants|||Count of Participants
851730|NCT01305941|Secondary|Time to Intracranial Progression.|"Time to intracranial progression after administration of everolimus in combination with trastuzumab and vinorelbine as defined via modified RECIST criteria.
Progressive Disease (PD) - at least a 20% increase in the sum LD of target lesions, taking as reference the smallest sum of the longest diameter recorded since the treatment started AND an absolute increase in size of at least 5 mm in at least one target lesion OR the appearance of one or more new lesions of at least 6 mm in size."|3 years|||months||95% Confidence Interval|Median
851731|NCT01305941|Secondary|Toxicity|"Grade 3 or higher toxicities of interest are reported. Toxicity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.
The NCI CTCAE is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE."|24 weeks|||Participants|||Count of Participants
851732|NCT01305941|Secondary|Intracranial Response Rate- MacDonald Criteria|"Intracranial tumor lesions were evaluated via gadolinium-enhanced brain MRI using the MacDonald criteria. Measurable disease is defined as at least 1 measurable brain lesion accurately measured in at least 2 dimensions (longest diameter) as ≥5.0 mm. Tumor size is the product of the 2 longest bi-dimensional lines.
Complete Response (CR)- Disappearance of all tumor on consecutive CT or MRI scans at least 1 month apart, off steroids for treatment of neurological symptoms, and neurologically stable or improved.
Partial Response (PR)- ≥50% reduction in size of tumor on consecutive CT or MRI scans at least 1 month part, steroids stable or reduced, and neurologically stable or improved.
Progressive Disease (PD)- ≥25% increase in size of tumor or any new tumor on CT or MRI scans, or neurologically worse, and steroids stable or increased due to neurologic symptoms.
Stable Disease (SD)- all other situations Overall Response Rate (ORR) is the sum of partial responses (PRs) and CRs."|3 years|Six subjects were not evaluable for response because there was no follow-up disease assessment done due to poor clinical status of subjects||Participants|||Count of Participants
851733|NCT01305941|Primary|Intracranial Objective Response Rate- Modified RECIST Criteria|"response will be evaluated via gadolinium-enhanced brain MRI using modified RECIST criteria.
Complete Response (CR) - Disappearance of all target and nontarget lesions
Partial Response (PR) - at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum longest diameter AND an absolute decrease of at least 5mm in at least one target lesion.
Stable Disease (SD) - neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum of the longest diameter since the treatment started.
Progressive Disease (PD) – at least a 20% increase in the sum LD of target lesions, taking as reference the smallest sum of the longest diameter recorded since the treatment started AND an absolute increase in size of at least 5 mm in at least one target lesion OR the appearance of one or more new lesions of at least 6 mm in size."|3 years|Six subjects were not evaluable for response because there was no follow-up disease assessment done due to poor clinical status of subjects||Participants|||Count of Participants
852154|NCT00855413|Secondary|Minimum Ritonavir Exposure Range in Cerebrospinal Fluid Among Participants Who Consented to an Optional Lumbar Puncture||Week 4 and week 48|Four participants consented to 7 optional lumbar puncture to provide CSF sample for measurement of drug levels.||ng/mL|||Number
851809|NCT01275053|Primary|Leptin Signaling|"Leptin signaling is assessed before and 30 minutes after in vivo metreleptin administration.
The primary outcome was p-STAT3/STAT3 in biopsies (fat tissue) before and 30 minutes after in vivo metreleptin administration.
The p-STAT3/STAT3 before metreleptin administration was given the value 1, and the p-STAT3/STAT3 30 minutes after in vivo metreleptin administration was given the value showing the fold change compared to p-STAT3/STAT3 before metreleptin administration."|Baseline and 30 minutes|All subjects received biopsies before and 30 min after leptin administration.||fold change||Full Range|Mean
852155|NCT00855413|Secondary|Maximum Ritonavir Exposure in Cerebrospinal Fluid Among Participants Who Consented to an Optional Lumbar Puncture||Week 4 and Week 48|Four participants consented to 7 optional lumbar puncture to provide CSF sample for measurement of drug levels.||ng/mL|||Number
851818|NCT01249404|Other Pre-specified|Mean Change From Baseline in Lower Limb Pain at Weeks 1, 4 and 12|The intensity of lower limb pain was evaluated using the Scale of Pain Intensity (SPIN) which provided a pictorial representation of pain in a 6-point graphic scale with the degree of red shading inside a circle representing the intensity of pain. The bottom and top of the scale are anchored by two extremes: ‘no pain’ (circle with no red shading and scored as 0) and ‘pain as bad as it could be’ (circle completely red and scored as 5), marked with either verbal or visual cues. The intervening points are represented by red circles increasing proportionally in size. The subject marks the circle that best indicates their pain intensity. The SPIN assessments were obtained prior to the study treatment at baseline, and then after injection at Weeks 1, 4 and 12, and at discretionary visits when needed at Weeks 16, 20 and 24 and at end of study. The mean change from baseline at Weeks 1, 4 and 12 are reported.|Baseline and Weeks 1, 4 and 12|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.||units on a scale||95% Confidence Interval|Least Squares Mean
851819|NCT01249404|Other Pre-specified|Mean Change From Baseline in the Range of Active Dorsiflexion at Weeks 1, 4 and 12 (Knee Extended and Flexed)|Range of active dorsiflexion of the ankle joint, both with the knee flexed (90°) and extended (measured by goniometry) was used to assess treatment response. The measurements were made prior to the study treatment at baseline, and then after injection at Weeks 1, 4 and 12, and at discretionary visits when needed at Weeks 16, 20 and 24 and at end of study. The mean change from baseline at Weeks 1, 4 and 12 are reported.|Baseline and Weeks 1, 4 and 12|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.||Degrees||95% Confidence Interval|Least Squares Mean
851820|NCT01249404|Other Pre-specified|Mean Change From Baseline in the Tardieu Scale in the Soleus (Knee Flexed) at Weeks 1, 4 and 12: Spasticity Grade (Y)|The Tardieu Scale in the soleus was used to assess spasticity with the knee flexed. The spasticity grade (Y) assesses quality of muscle reaction on a 5-point scale (measured at fast speed): 0 = no resistance throughout passive movement; 1 = slight resistance throughout passive movement; 2 = clear catch at precise angle, interrupting passive movement, followed by release; 3 = fatigable clonus (less than 10 seconds when maintaining pressure) occurring at a precise angle, followed by release; 4 = unfatigable clonus (more than 10 seconds when maintaining pressure) occurring at precise angle. The Tardieu Scale ratings were made prior to the study treatment at baseline, and then after injection at Weeks 1, 4 and 12, and at discretionary visits if required at Weeks 16, 20 and 24 and at end of study. The mean change from baseline for spasticity grade at Weeks 1, 4 and 12 are reported.|Baseline and Weeks 1, 4 and 12|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.||units on a scale||95% Confidence Interval|Least Squares Mean
851821|NCT01249404|Other Pre-specified|Mean Change From Baseline in the Tardieu Scale in the Soleus (Knee Flexed) at Weeks 1, 4 and 12: Angle of Arrest (XV1), Angle of Catch (XV3) and Spasticity Angle (X)|The Tardieu Scale in the soleus was used to assess spasticity with the knee flexed. Assessments were made at slow (V1) and fast (V3) speeds of stretch. Slow speed of muscle stretch measures the range of passive motion. During a slow stretching movement, the examiner determines the angle of movement arrest (XV1), either due to subject discomfort or a mechanical resistance. The same movement is repeated at a fast speed to determine the angle of catch and release (XV3). The spasticity angle (X) was calculated as the difference between XV1 and XV3. The Tardieu Scale ratings were made prior to the study treatment at baseline, and then after injection at Weeks 1, 4 and 12, and at discretionary visits if required at Weeks 16, 20 and 24 and at end of study. The mean change from baseline at Weeks 1, 4 and 12 are reported.|Baseline and Weeks 1, 4 and 12|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.||Degrees||95% Confidence Interval|Least Squares Mean
851822|NCT01249404|Other Pre-specified|Mean Change From Baseline in the Tardieu Scale in the GSC (Knee Extended) at Weeks 1, 4 and 12: Spasticity Grade (Y)|The Tardieu Scale in the GSC was used to assess spasticity with the knee extended. The spasticity grade (Y) assesses quality of muscle reaction on a 5-point scale (measured at fast speed): 0 = no resistance throughout passive movement; 1 = slight resistance throughout passive movement; 2 = clear catch at precise angle, interrupting passive movement, followed by release; 3 = fatigable clonus (less than 10 seconds when maintaining pressure) occurring at a precise angle, followed by release; 4 = unfatigable clonus (more than 10 seconds when maintaining pressure) occurring at precise angle. The Tardieu Scale ratings were made prior to the study treatment at baseline, and then after injection at Weeks 1, 4 and 12, and at discretionary visits if required at Weeks 16, 20 and 24 and at end of study. The mean change from baseline for spasticity grade at Weeks 1, 4 and 12 are reported.|Baseline and Weeks 1, 4 and 12|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.||units on a scale||95% Confidence Interval|Least Squares Mean
851823|NCT01249404|Other Pre-specified|Mean Change From Baseline in the Tardieu Scale in the GSC (Knee Extended) at Weeks 1, 4 and 12: Angle of Arrest (XV1), Angle of Catch (XV3) and Spasticity Angle (X)|The Tardieu Scale in the GSC was used to assess spasticity with the knee extended. Assessments were made at slow (V1) and fast (V3) speeds of stretch. Slow speed of muscle stretch measures the range of passive motion. During a slow stretching movement, the examiner determines the angle of movement arrest (XV1), either due to subject discomfort or a mechanical resistance. The same movement is repeated at a fast speed to determine the angle of catch and release (XV3). The spasticity angle (X) was calculated as the difference between XV1 and XV3. The Tardieu Scale ratings were made prior to the study treatment at baseline, and then after injection at Weeks 1, 4 and 12, and at discretionary visits if required at Weeks 16, 20 and 24 and at end of study. The mean change from baseline at Weeks 1, 4 and 12 are reported.|Baseline and Weeks 1, 4 and 12|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.||Degrees||95% Confidence Interval|Least Squares Mean
851824|NCT01249404|Other Pre-specified|Mean Change From Baseline in Average Step Length With Maximal Barefoot Walking Speed at Weeks 1, 4 and 12|Average step length was assessed during the 10-metre walking speed test at maximal walking speed and barefoot. The evaluator walked beside the subject during the test and counted the number of steps taken during the 10-metre walk. The gait parameters were measured at baseline, Weeks 1, 4 and 12, discretionary visits at Weeks 16, 20 and 24 and at end of study. The mean change from baseline at Weeks 1, 4 and 12 are reported.|Baseline and Weeks 1, 4 and 12|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.||m/step||95% Confidence Interval|Least Squares Mean
851825|NCT01249404|Other Pre-specified|Mean Change From Baseline in Cadence With Maximal Barefoot Walking Speed at Weeks 1, 4 and 12|Cadence was assessed during the 10-metre walking speed test at maximal walking speed and barefoot. The evaluator walked beside the subject during the test and counted the number of steps taken during the 10-metre walk. The gait parameters were measured at baseline, Weeks 1, 4 and 12, discretionary visits at Weeks 16, 20 and 24 and at end of study. The mean change from baseline at Weeks 1, 4 and 12 are reported.|Baseline and Weeks 1, 4 and 12|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.||steps/s||95% Confidence Interval|Least Squares Mean
851826|NCT01249404|Other Pre-specified|Mean Change From Baseline in Average Step Length With Maximal Walking Speed With Shoes at Weeks 1, 4 and 12|Average step length was assessed during the 10-metre walking speed test at maximal walking speed and with shoes. The evaluator walked beside the subject during the test and counted the number of steps taken during the 10-metre walk. The gait parameters were measured at baseline, Weeks 1, 4 and 12, discretionary visits at Weeks 16, 20 and 24 and at end of study. The mean change from baseline at Weeks 1, 4 and 12 are reported.|Baseline and Weeks 1, 4 and 12|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.||m/step||95% Confidence Interval|Least Squares Mean
851835|NCT01249404|Other Pre-specified|Mean Change From Baseline in Comfortable Barefoot Walking Speed at Weeks 1 and 12|Comfortable walking speed was assessed as a measure of functional ability and gait over 10 metres. Evaluations were made barefoot, without walking aids, at baseline and Weeks 1, 4 and 12 and discretionary visits at Weeks 16, 20 and 24 and at end of study. The mean change from baseline at Weeks 1 and 12 are reported.|Baseline and Weeks 1 and 12|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.||m/s||95% Confidence Interval|Least Squares Mean
851827|NCT01249404|Other Pre-specified|Mean Change From Baseline in Cadence With Maximal Walking Speed With Shoes at Weeks 1, 4 and 12|Cadence was assessed during the 10-metre walking speed test at maximal walking speed and with shoes. The evaluator walked beside the subject during the test and counted the number of steps taken during the 10-metre walk. The gait parameters were measured at baseline, Weeks 1, 4 and 12, discretionary visits at Weeks 16, 20 and 24 and at end of study. The mean change from baseline at Weeks 1, 4 and 12 are reported.|Baseline and Weeks 1, 4 and 12|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.||steps/s||95% Confidence Interval|Least Squares Mean
851828|NCT01249404|Other Pre-specified|Mean Change From Baseline in Average Step Length With Comfortable Barefoot Walking Speed at Weeks 1, 4 and 12|Average step length was assessed during the 10-metre walking speed test at comfortable walking speed and barefoot. The evaluator walked beside the subject during the test and counted the number of steps taken during the 10-metre walk. The gait parameters were measured at baseline, Weeks 1, 4 and 12, discretionary visits at Weeks 16, 20 and 24 and at end of study. The mean change from baseline at Weeks 1, 4 and 12 are reported.|Baseline and Weeks 1, 4 and 12|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.||m/step||95% Confidence Interval|Least Squares Mean
851829|NCT01249404|Other Pre-specified|Mean Change From Baseline in Cadence With Comfortable Barefoot Walking Speed at Weeks 1, 4 and 12|Cadence was assessed during the 10-metre walking speed test at comfortable walking speed and barefoot. The evaluator walked beside the subject during the test and counted the number of steps taken during the 10-metre walk. The gait parameters were measured at baseline, Weeks 1, 4 and 12, discretionary visits at Weeks 16, 20 and 24 and at end of study. The mean change from baseline at Weeks 1, 4 and 12 are reported|Baseline and Weeks 1, 4 and 12|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.||steps/s||95% Confidence Interval|Least Squares Mean
851830|NCT01249404|Other Pre-specified|Mean Change From Baseline in Average Step Length With Comfortable Walking Speed With Shoes at Weeks 1, 4 and 12|Average step length was assessed during the 10-metre walking speed test at comfortable walking speed and with shoes. The evaluator walked beside the subject during the test and counted the number of steps taken during the 10-metre walk. The gait parameters were measured at baseline, Weeks 1, 4 and 12, discretionary visits at Weeks 16, 20 and 24 and at end of study. The mean change from baseline at Weeks 1, 4 and 12 are reported.|Baseline and Weeks 1, 4 and 12|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.||m/step||95% Confidence Interval|Least Squares Mean
851831|NCT01249404|Other Pre-specified|Mean Change From Baseline in Cadence With Comfortable Walking Speed With Shoes at Weeks 1, 4 and 12|Cadence was assessed during the 10-metre walking speed test at comfortable walking speed and with shoes. The evaluator walked beside the subject during the test and counted the number of steps taken during the 10-metre walk. The gait parameters were measured at baseline, Weeks 1, 4 and 12, discretionary visits at Weeks 16, 20 and 24 and at end of study. The mean change from baseline at Weeks 1, 4 and 12 are reported.|Baseline and Weeks 1, 4 and 12|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.||steps/s||95% Confidence Interval|Least Squares Mean
851832|NCT01249404|Other Pre-specified|Mean Change From Baseline in Maximal Walking Speed With Shoes at Weeks 1, 4 and 12|Maximal walking speed was assessed as a measure of functional ability and gait over 10 metres. Evaluations were made with shoes, without walking aids, at baseline and Weeks 1, 4 and 12 and discretionary visits at Weeks 16, 20 and 24 and at end of study. The mean change from baseline at Weeks 1, 4 and 12 are reported.|Baseline and Weeks 1, 4 and 12|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.||m/s||95% Confidence Interval|Least Squares Mean
851833|NCT01249404|Other Pre-specified|Mean Change From Baseline in Maximal Barefoot Walking Speed at Weeks 1, 4 and 12|Maximal walking speed was assessed as a measure of functional ability and gait over 10 metres. Evaluations were made barefoot, without walking aids, at baseline and Weeks 1, 4 and 12 and discretionary visits at Weeks 16, 20 and 24 and at end of study. The mean change from baseline at Weeks 1, 4 and are reported.|Baseline and Weeks 1, 4 and 12|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.||m/s||95% Confidence Interval|Least Squares Mean
851834|NCT01249404|Other Pre-specified|Mean Change From Baseline in Comfortable Walking Speed With Shoes at Weeks 1, 4 and 12|Comfortable walking speed was assessed as a measure of functional ability and gait over 10 metres. Evaluations were made with shoes, without walking aids, at baseline and Weeks 1, 4 and 12 and discretionary visits at Weeks 16, 20 and 24 and at end of study. The mean change from baseline at Weeks 1, 4 and 12 are reported.|Baseline and Weeks 1, 4 and 12|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.||m/s||95% Confidence Interval|Least Squares Mean
851836|NCT01249404|Other Pre-specified|PGA of Treatment Response at Week 12|An assessment of overall treatment response was conducted at Weeks 4 and 12, and discretionary visits at Weeks 16, 20 and 24 and at end of study by an investigator who had not assessed the MAS. The investigator rated the response to treatment in the subject's lower limb after injection of Dysport® relative to the status at the baseline. Answers were made on a 9 point rating scale: -4=markedly worse, -3=much worse, -2=worse, -1=slightly worse, 0=no change, +1=slightly improved, +2=improved, +3=much improved, +4=markedly improved. The mean PGA scores at Week 12 are reported.|At Week 12|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data at Week 12 are included in the analysis.||units on a scale||95% Confidence Interval|Least Squares Mean
851837|NCT01249404|Other Pre-specified|Mean Change From Baseline in MAS Score in the Soleus (Knee Flexed) at Weeks 1, 4 and 12|Muscle tone in the treated limb was assessed by MAS in the soleus (with the knee flexed) at baseline, at Weeks 1, 4 and 12, at discretionary visits at Weeks 16, 20 and 24, and at end of study. The MAS consists of 6 grades: 0 (no increase in muscle tone), 1 (slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the ROM), 1+ (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM), 2 (more marked increase in muscle tone), 3 (considerable increase in muscle tone) or 4 (affected part(s) rigid in flexion or extension), and can be applied to muscles of both the upper and lower limbs. The mean change from baseline at Weeks 1, 4 and 12 are reported.|Baseline and Weeks 1, 4 and 12|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.||units on a scale||95% Confidence Interval|Least Squares Mean
851838|NCT01249404|Other Pre-specified|Mean Change From Baseline in MAS Score in the GSC (Knee Extended) at Weeks 1 and 12|Muscle tone in the treated limb was assessed by MAS in the GSC (with the knee extended) at baseline, at Weeks 1, 4 and 12, at discretionary visits at Weeks 16, 20 and 24, and at end of study. The MAS consists of 6 grades: 0 (no increase in muscle tone), 1 (slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the ROM), 1+ (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM), 2 (more marked increase in muscle tone), 3 (considerable increase in muscle tone) or 4 (affected part(s) rigid in flexion or extension), and can be applied to muscles of both the upper and lower limbs. The mean change from baseline at Weeks 1 and 12 are reported.|Baseline and Weeks 1 and 12|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.||units on a scale||95% Confidence Interval|Least Squares Mean
851839|NCT01249404|Secondary|Mean Change From Baseline to Week 4 in Comfortable Barefoot Walking Speed|Comfortable walking speed was assessed as a measure of functional ability and gait over 10 metres. Evaluations were made barefoot, without walking aids, at baseline and Weeks 1, 4 and 12 and discretionary visits at Weeks 16, 20 and 24 and at end of study. The mean change from baseline at Week 4 is reported.|Baseline and Week 4|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data at baseline and Week 4 are included in the analysis.||m/s||95% Confidence Interval|Least Squares Mean
851840|NCT01249404|Secondary|Physician's Global Assesment (PGA) of Treatment Response at Week 4|An assessment of overall treatment response was conducted at Weeks 4 and 12, and discretionary visits at Weeks 16, 20 and 24 and at end of study by an investigator who had not assessed the MAS. The investigator rated the response to treatment in the subject's lower limb after injection of Dysport® relative to the status at the baseline. Answers were made on a 9 point rating scale: -4=markedly worse, -3=much worse, -2=worse, -1=slightly worse, 0=no change, +1=slightly improved, +2=improved, +3=much improved, +4=markedly improved. The mean PGA score at Week 4 is reported.|At Week 4|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data at Week 4 are included in the analysis.||units on a scale||95% Confidence Interval|Least Squares Mean
851841|NCT01249404|Primary|Mean Change From Baseline to Week 4 in the MAS Score in the Gastrocnemius-soleus Complex (GSC) (Knee Extended)|Muscle tone in the treated limb was assessed by MAS in the GSC (with the knee extended) at baseline, at Weeks 1, 4 and 12, at discretionary visits at Weeks 16, 20 and 24, and at end of study. The MAS consists of 6 grades: 0 (no increase in muscle tone), 1 (slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion (ROM)), 1+ (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM), 2 (more marked increase in muscle tone), 3 (considerable increase in muscle tone) or 4 (affected part(s) rigid in flexion or extension), and can be applied to muscles of both the upper and lower limbs. The mean change from baseline at Week 4 is reported.|Baseline and Week 4|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4.||units on a scale||95% Confidence Interval|Least Squares Mean
852156|NCT00855413|Secondary|Minimum Darunavir Exposure in Cerebrospinal Fluid Among Participants Who Consented to an Optional Lumbar Puncture||Week 4 and week 48|Four participants consented to 7 optional lumbar puncture to provide CSF sample for measurement of drug levels.||ng/mL|||Number
852157|NCT00855413|Secondary|Maximum Darunavir Exposure in Cerebrospinal Fluid Among Participants Who Consented to an Optional Lumbar Puncture||Week 4 and week 48|Four participants consented to 7 optional lumbar puncture to provide CSF sample for measurement of drug levels.||ng/mL|||Number
852035|NCT01098071|Primary|Number of Participants Referred to Surgery (Adenoidectomy) Within 12 Weeks of Start of Therapy||Baseline to 12 weeks|Evaluable population (per protocol population, ie, those participants without protocol violation of inclusion or exclusion criteria)||Participants|||Number
852015|NCT01147172|Primary|Pigmentation Changes at Site of Injection|Percentage of subjects with pigmentation changes at site of injection at End of Study|24 Weeks|Safety Population||Percentage (%) of subjects|||Number
852016|NCT01147172|Primary|Pigmentation Changes at Site of Injection|Percentage of Subjects with pigmentation changes at site of injection|12 Weeks|Safety Population||Percentage (%) of subjects|||Number
852017|NCT01147172|Primary|Pigmentation Changes at Site of Injection|Percentage of Subjects with pigmentation changes at site of injection|6 Weeks|Safety Population||Percentage (%) of subjects|||Number
852018|NCT01147172|Primary|Pigmentation Changes at Site of Injection|Percentage of Subjects with pigmentation changes at site of injection|2 Weeks|Safety Population||Percentage (%) of subjects|||Number
852019|NCT01147172|Primary|Keloid Formation at Site of Injection|Percentage of subjects with keloid formation at the site of injection at End of Study|24 Weeks|Safety Population||Percentage (%) of subjects|||Number
852020|NCT01147172|Primary|Keloid Formation at Site of Injection|Percentage of Subjects with keloid formation at the site of injection|12 Weeks|Safety Population||Percentage (%) of subjects|||Number
852021|NCT01147172|Primary|Keloid Formation at Site of Injection|Percentage of Subjects with keloid formation at the site of injection|6 Weeks|Safety Population||Percentage (%) of subjects|||Number
852022|NCT01147172|Primary|Keloid Formation at Site of Injection|Percentage of Subjects with keloid formation at the site of injection|2 Weeks|Safety Population||percentage of participants|||Number
852030|NCT01098071|Secondary|Severity of Eye Symptoms at Baseline and Week 12|Eye symptoms are a symptom of allergic rhinitis. Eye symptoms were assessed using a 3-point scale (0 = no symptoms [best score] and 3 = symptom interferes with daily life activity [worst score]).|Baseline and Week 12|Participants suspected to have allergic rhinitis||Score on a scale||Full Range|Mean
852031|NCT01098071|Secondary|Severity of Sneezing at Baseline and Week 12|Sneezing is a symptom of allergic rhinitis. Sneezing was assessed using a 3-point scale (0 = no symptoms [best score] and 3 = symptom interferes with daily life activity [worst score]).|Baseline and Week 12|Participants suspected to have allergic rhinitis||Score on a scale||Full Range|Mean
852032|NCT01098071|Secondary|Severity of Nasal Itching at Baseline and Week 12|Nasal itching is a symptom of allergic rhinitis. Nasal itching was assessed using a 3-point scale (0 = no symptoms [best score] and 3 = symptom interferes with daily life activity [worst score]).|Baseline and Week 12|Participants suspected to have allergic rhinitis||Score on a scale||Full Range|Mean
852033|NCT01098071|Secondary|Severity of Nasal Congestion at Baseline and Week 12|Nasal congestion is a symptom of allergic rhinitis. Nasal congestion was assessed using a 3-point scale (0 = no symptoms [best score] and 3 = symptom interferes with daily life activity [worst score]).|Baseline and Week 12|Participants suspected to have allergic rhinitis||Score on a scale||Full Range|Mean
852034|NCT01098071|Secondary|Severity of Rhinorrhea at Baseline and Week 12|Rhinorrhea is a symptom of allergic rhinitis. Rhinorrhea was assessed using a 3-point scale (0 = no symptoms [best score] and 3 = symptom interferes with daily life activity [worst score]).|Baseline and Week 12|Participants suspected to have allergic rhinitis||Score on a scale||Full Range|Mean
852036|NCT01098071|Primary|Degree of Posterior Choana Obstruction at Baseline and Week 12|The degree of obstruction of the posterior choana was assessed by endoscopy. Endoscopy grading consisted of Grade I (minimum), Grade II and Grade III (maximum). Grade I was defined as <50% obstruction, Grade II was defined as 50-75% obstruction, and Grade III was defined as >75% obstruction.|Baseline and Week 12|Only participants that completed the study are included.||Percent obstruction||Full Range|Mean
852037|NCT01098071|Primary|Severity of Nasal Obstruction Symptoms at Baseline and Week 12 as Measured by the Total Clinical Score|Clinical score (based on a 5 point grading system) was assessed for each of 5 nasal obstruction symptoms (oral/mouth breathing, snoring, restless sleep, frequent waking-ups during the night, and obstructive breathing during sleep). Each nasal obstruction symptom was estimated by the parent/guardian of the participant and scored on a scale of 0 (best) to 1 (worst). Total clinical score is a score on a scale (0 = no symptoms [best score] and 5 = worst symptoms [worst score]).|Baseline and Week 12|||Score on a scale||Full Range|Mean
852050|NCT01033227|Secondary|Secondary End Point|a) reduced the duration and intensity of pain; b) reduced total narcotic analgesic consumption; and c) reduced length of hospitalization.|48 hours|Data were *not collected* and the Outcome was never analyzed, study terminated|||||
852051|NCT01033227|Primary|48 Hour Sodium Nitrite Infusion Safety as Determined by Number of Participants With No Adverse Events|The primary end points will be to determine if a) a 48-hour sodium nitrite infusion is tolerated without a decrease in mean arterial blood pressure by 15mmHg for greater than 2 hours or development of methemoglobin greater than 5% and b) a 48-hour sodium nitrite infusion is safe as determined by monitoring for adverse events|48 hours from start of infusion|||Participants|||Count of Participants
852158|NCT00855413|Secondary|Minimum Etravirine Exposure in Cerebrospinal Fluid Among Participants Who Consented to an Optional Lumbar Puncture||Week 4 and week 48|4 participants consented to 7 optional lumbar puncture to provide CSF sample for measurement of drug levels.||ng/mL|||Number
852084|NCT00989781|Other Pre-specified|Follicle Count on 3-D Ultrasound in PCOS Women and Normal Controls|3-D ultrasound was not assessed; instead 2-D ultrasound was performed|baseline|||Antral Follicle Count||Standard Error|Mean
852085|NCT00989781|Secondary|Anti-Mullerian Hormone (AMH)||Baseline|||ng/ml||Standard Error|Mean
852086|NCT00989781|Secondary|17-hydroxyprogesterone Response to hCG in the Setting of Reduced Insulin Secretion in PCOS Women|We were unable to recruit sufficient numbers of subjects for this study. Therefore, none of the subjects had data for analysis as no hormone measurements were performed.|Baseline and 24 after hCG||||||
852087|NCT00989781|Secondary|Adrenal 17-hydroxyprogesterone Response to ACTH in PCOS Women and Normal Controls|17-hydroxyprogesterone response to ACTH infusion in women with PCOS and normal women. Response is reported as a single value generated by summing the data at end time frame.|Baseline and 1, 2, 3, 4, 5, and 6 hours after ACTH|||ng/ml||Standard Error|Mean
852088|NCT00989781|Primary|17-hydroxyprogesterone Responses to hCG in PCOS Women and Normal Controls|Change from baseline in 17-hydroxyprogesterone at 24 hours after hCG injection|Baseline and 24 hours after hCG|||ng/ml||Standard Error|Mean
852134|NCT00855413|Secondary|Change in Overall Neurocognitive Impairment From Baseline to Week 24 or 48|Change in overall z score from baseline to week 24 or 48. A negative z score denotes below-average performance relative to a US normative comparison population. A higher z score is a better outcome.|Baseline to Week 24 or 48|Participants who underwent neurocognitive assessment at baseline and Week 24 and/or 48.||z score||Standard Deviation|Mean
852126|NCT00859573|Secondary|Vital Signs||thrice weekly||||||
852127|NCT00859573|Secondary|Attentional Neurophysiological Measures||week 0, 2, 10||||||
852128|NCT00859573|Secondary|Pre-attentional Neurophysiological Measures||week 0, week 2, week 10||||||
852129|NCT00859573|Primary|Withdrawal Symptoms||thrice weekly||||||
852130|NCT00859573|Primary|Mean Treatment Effectiveness Scores|Number of negative drug screens for methamphetamine during the study (every negative drug screen obtained is counted as 1 negative drug screen)divided by the total possible number of drug screens during the 6 week post residential phase of trial(participants provided 3 drug screens per week so the expected number of drug screens total is 18.This does include week 8. Missing drug screens are counted as positive.# negative drug screens/18. Minimum score is 0 and maximum score is 1. The higher the score the better the outcome. The mean of the individual treatment effectiveness scores is reported.|thrice weekly from week 3 through week 8|Participants that completed the 2 week residential treatment and entered the outpatient phase with intent to treat and missing urines treated as positive urines.||scores on a scale||Standard Deviation|Mean
852131|NCT00855413|Secondary|HIV RNA Detection in Ileal Biopsy Specimens|Average HIV RNA detected in the ileal biopsy specimens per participant over weeks 4 and 48.|Weeks 4 and 48|Study stopped prior to target enrollment by sponsor. Given insufficient ileal biopsy samples, correlation of HIV viremia in ileal biopsies with time to suppression was not performed due to inadequate power to analyze the outcome.||copies/mL||Full Range|Mean
852132|NCT00855413|Secondary|Correlation of Time to HIV RNA Levels <200 Copies/mL With Improvement in Neurocognitive Functioning From Baseline to Week 24 and 48||Baseline to Week 24 and 48|Participants who consented to optional neurocognitive assessments at baseline and week 24 or 48||r value|||Number
852133|NCT00855413|Secondary|Correlation of HIV RNA Levels in CSF and Drug Levels With Neurocognitive Functioning||From enrollment through Week 48|Participants who consented to neurocognitive assessments at baseline and week 24 or 48. Sponsor stopped study prior to target enrollment.||r value|||Number
852135|NCT00855413|Secondary|Overall Neurocognitive Impairment at Week 48|Neuropsychological performance was assessed at baseline (week 2 or 4), week 24 and week 48 in the following domain (measures): Premorbid/language (Wide Range Achievement Test (WRAT) 4 - Reading Subtest), Learning (HVLT-R, Hopkins Verbal Learning Test – Revised), Memory (HVLT-R), Speed of Processing (Trailmaking A (Army Individual Test Battery, 1944), 1974, Stroop color, Attention (WAIS-III Symbol Search; Stroop word, Fine motor, Executive (Trailmaking B, Stroop interference, Letter, Category Fluency. An overall summary score of neurocognitive functioning was created by averaging all tests. Participants also completed the self-reported functional status Patient's Assessment of Own Functioning Inventory (PAOFI) and the Activities of Daily Living Scale (ADLS). Best available demographically corrected normative data were utilized to create z scores. A negative z score denotes below-average performance relative to a US normative comparison population. A higher z score is a better outcome.|Week 48|participants who underwent neurocognitive assessment at baseline and week 48||z score||Standard Deviation|Mean
852136|NCT00855413|Secondary|Overall Neurocognitive Impairment at Week 24|Neuropsychological performance was assessed at week 2 or 4, week 24 and week 48 in the following measures: Premorbid/language (Wide Range Achievement Test 4 -Reading Subtest), Learning (Hopkins Verbal Learning Test – Revised), Memory (HVLT-R), Speed of Processing (Trailmaking A (Army Individual Test Battery, 1944), 1974, Stroop color, Attention (WAIS-III Symbol Search; Stroop word, Fine motor, Executive (Trailmaking B, Stroop interference, Letter, Category Fluency. An overall summary score of neurocognitive functioning was created by averaging all tests. Participants also completed Patient's Assessment of Own Functioning Inventory (PAOFI) and the Activities of Daily Living Scale (ADLS). Best available demographically corrected normative data were utilized to create z scores. A negative z score denotes below-average performance relative to a US normative comparison population. A higher z score is a better outcome.|Week 24|participants who underwent neurocognitive assessment at baseline and week 24||z score||Standard Deviation|Mean
852137|NCT00855413|Secondary|Overall Neurocognitive Impairment Score at Week 2 or 4|Neuropsychological performance was assessed at Week 2 or 4, Week 24 and Week 48 in the following measures: Premorbid/language (Wide Range Achievement Test 4 -Reading Subtest), Learning (HVLT-R, Hopkins Verbal Learning Test–Revised), Memory (HVLT-R), Speed of Processing (Trailmaking A (Army Individual Test Battery, 1944), 1974, Stroop color, Attention (WAIS-III Symbol Search; Stroop word, Fine motor, Executive (Trailmaking B, Stroop interference, Letter, Category Fluency. An overall summary score was created by averaging all tests. Participants also completed the self-reported functional status Patient's Assessment of Own Functioning Inventory (PAOFI) and the Activities of Daily Living Scale (ADLS). Best available demographically corrected normative data were utilized to create z scores. A negative z score denotes below-average performance relative to a US normative comparison population. A higher z score is a better outcome.|Week 2 or 4|participants who underwent neurocognitive assessment at week 2 or 4||z score||Standard Deviation|Mean
852138|NCT00855413|Secondary|Number of Participants With Neurocognitive Impairment at Week 48||Week 48|Participants who consented to optional procedure of neurocognitive assessment at week 48||Participants|||Count of Participants
852139|NCT00855413|Secondary|Number of Participants With Neurocognitive Impairment at Week 24||Week 24|Participants who consented to optional procedure of neurocognitive assessment at week 24||Participants|||Count of Participants
852140|NCT00855413|Secondary|Number of Participants With Neurocognitive Impairment at Baseline||Week 2 or 4|Participants who consented to optional procedure of neurocognitive assessment at baseline||Participants|||Count of Participants
852141|NCT00855413|Secondary|Number of Participants With HIV RNA Measurement Above the Limits of Detection in Cerebrospinal Fluid||Week 4 and Week 48|Four participants provided 7 CSF samples for measurement of HIV RNA level||participants|||Number
852142|NCT00855413|Secondary|Minimum Ritonavir Exposure Range in Ileal Tissue Among Participants Who Consented to an Optional Gut Biopsy Procedure||between week 4-12 and between weeks 36-48|Six participants consented to ileal biopsy for measurement of drug levels||ng/g|||Number
852143|NCT00855413|Secondary|Maximum Ritonavir Exposure Range in Ileal Tissue Among Participants Who Consented to an Optional Gut Biopsy Procedure||between week 4-12 and between Weeks 36-48|Six participants consented to ileal biopsy for measurement of drug levels||ng/g|||Number
852144|NCT00855413|Secondary|Minimum Darunavir Exposure Range in Ileal Tissue Among Participants Who Consented to an Optional Gut Biopsy Procedure||between week 4-12 and between weeks 36-48|Six participants consented to ileal biopsy for measurement of drug levels||ng/g|||Number
852145|NCT00855413|Secondary|Maximum Darunavir Exposure Range in Ileal Tissue Among Participants Who Consented to an Optional Gut Biopsy Procedure||between Week 4-12 and between Weeks 36-48|Six participants consented to ileal biopsy for measurement of drug levels||ng/g|||Number
852146|NCT00855413|Secondary|Minimum Etravirine Exposure Range in Ileal Tissue Among Participants Who Consented to an Optional Gut Biopsy Procedure||between Week 4-12 and between Weeks 36-48|Six participants consented to ileal biopsy for measurement of drug levels||ng/g|||Number
852147|NCT00855413|Secondary|Maximum Etravirine Exposure in Ileal Tissue Among Participants Who Consented to an Optional Gut Biopsy Procedure||between Week 4-12 and between Weeks 36-48|Six participants consented to ileal biopsy for measurement of drug levels||ng/g|||Number
852148|NCT00855413|Secondary|Minimum Ritonavir Exposure in Semen Among Participants Who Consented to an Optional Collection of Semen||Weeks 0-4 and Weeks 12, 48|Four participants consented to provide a semen sample for measurement of drug levels.||ng/mL|||Number
852149|NCT00855413|Secondary|Maximum Ritonavir Exposure in Semen Among Participants Who Consented to an Optional Collection of Semen||Weeks 0-4 and Weeks 12, 48|Four participants consented to provide a semen sample for measurement of drug levels.||ng/mL|||Number
852150|NCT00855413|Secondary|Minimum Darunavir Exposure Range in Semen Among Participants Who Consented to an Optional Collection of Semen||Weeks 0-4 and weeks 12, 48|Four participants consented to provide a semen sample for measurement of drug levels.||ng/mL|||Number
852151|NCT00855413|Secondary|Maximum Darunavir Exposure in Semen Among Participants Who Consented to an Optional Collection of Semen||Weeks 0-4 and weeks 12, 48|Four participants consented to provide a semen sample for measurement of drug levels.||ng/mL|||Number
852152|NCT00855413|Secondary|Minimum Etravirine Exposure in Semen Among Participants Who Consented to an Optional Collection of Semen||Weeks 0-4 and weeks 12, 48|Four participants consented to provide a semen sample for measurement of drug levels.||ng/mL|||Number
852159|NCT00855413|Secondary|Maximum Etravirine Exposure in Cerebrospinal Fluid Among Participants Who Consented to an Optional Lumbar Puncture||Week 4 and week 48|4 participants consented to 7 optional lumbar punctures to provide CSF samples for measurement of drug levels.||ng/mL|||Number
852160|NCT00855413|Secondary|Adverse Events Possibly or Definitely Related to Study Treatment Through Week 48|Total number of adverse events observed that were possibly or definitely related to study treatment through week 48|Enrollment to week 48|||adverse events|||Number
852161|NCT00855413|Secondary|Number of Participants Who Stopped Study Treatment Due to Adverse Event or Intolerance||Enrollment to Week 48|||Participants|||Count of Participants
852162|NCT00855413|Secondary|HIV RNA Detection in Semen|Total cumulative levels of HIV RNA detected in the semen of participants from enrollment through week 48.|From enrollment through 48 weeks|Study stopped prior to target enrollment by sponsor. Given insufficient semen samples, correlation of HIV viremia in semen with time to suppression was not performed due to inadequate power to analyze the outcome.||copies/mL||Full Range|Mean
852163|NCT00855413|Secondary|Median Time to HIV RNA Suppression to <200 Copies/mL||From enrollment to the date of HIV RNA suppression, assessed up to Week 48|||days||Full Range|Median
852164|NCT00855413|Secondary|HIV RNA Levels Immediately Prior to Initiating Study Treatment.||HIV RNA level at enrollment|||copies/mL||Full Range|Median
852165|NCT00855413|Secondary|Median Change in CD4 Cell Count From Week 0 to Week 48.||48 weeks from enrollment|12 participants with a week 48 study visit were included in analysis||cells/mm^3||Full Range|Median
852166|NCT00855413|Secondary|Median Change in CD4 Cell Count From Week 0 to Week 24.||week 0, week 24|All participants enrolled were included in this analysis||cells/mm^3||Full Range|Median
852167|NCT00855413|Secondary|Number of Participants With Virologic Response|Virologic response to study treatment defined as plasma HIV RNA measurement <50 copies/mL at week 48|48 weeks from enrollment|All participants retained on study through week 48 were included in the analysis of virologic efficacy at week 48||Participants|||Count of Participants
852168|NCT00855413|Primary|Number of Participants With Virologic Response|Virologic response defined as plasma HIV RNA measurement <200 copies/mL at week 24|24 weeks|All participants enrolled were included in analysis of virologic response||Participants|||Count of Participants
852250|NCT00577512|Secondary|Duration of Response||12 months||||||
852251|NCT00577512|Primary|Number of Subjects Treated With (HD DTPACE Obtain a Complete Response or Near Complete Response That Lasts for 6 Months or Longer.|"Complete Response (CR) defined as all of the following for a minimum of 2 months: a) absence of urine and serum M-components by immunofixation; b) bone marrow should be adequately cellular (>20%); c) normal serum calcium; d) no new bone lesions or enlargement of existing lesions.
Near Complete Response included all elements of CR except immunofixation studies remained positive."|12 months|||participant response|||Number
852252|NCT00574080|Secondary|Side Effects With Both Transplant Regimens|side effects from adding three drugs, bortezomib, thalidomide, and dexamethasone (VTD) to the high dose chemotherapy regimen immediately before transplant (DPACE/Melphalan)vs. side effects of treatment with high-dose chemotherapy not containing these drug|24 months||||||
852253|NCT00574080|Primary|Event Free Survival|Time from study registration until disease progression or death.|Up to 3 years 8 months|no analysis, participants either died or were withdrawn by PI. study terminated with <10% of target accrual enrolled.|||||
852254|NCT00568178|Primary|Open Label Extension: Change From Baseline in Glomerular Filtration Rate (GFR) at Month 36|"The outcome measure of glomerular filtration rate was based on mL/min/1.73m^2, as determined by the Schwartz formula:
GFR = _____0.55 x height (cm)_______ divided by serum creatinine (mg/dL)
GFR values were compared to the baseline GFR measure.
[Note: For male participants, ages 13 to 17 years, 0.70 was used as
the multiplier in place of 0.55]
Baseline in regard to the extension is defined as the last value obtained in the double-blind treatment phase."|Baseline and Month 36|Data for analysis was obtained only from participants who had: 1) Baseline measure of Pr/Cr, 2) At least one dose of study drug, and 3) Post randomization measure of Pr/Cr. The number of participants was determined by including only individuals who satisfied the criteria.||Change in GFR mL/min1.73m^2||95% Confidence Interval|Least Squares Mean
852255|NCT00568178|Primary|Open Label Extension: Percent Change From Baseline of Urinary Pr/Cr Ratio (gm/gm) at Month 36|"Change in urinary protein excretion, determined as urinary Pr/Cr ratio compared to baseline*, after approximately three years of treatment.
*The baseline for efficacy data in the extension was defined as the last value obtained in the double-blind treatment phase."|Baseline and Month 36|Data for analysis was obtained only from participants who had: 1) Baseline measure of Pr/Cr, 2) At least one dose of study drug, and 3) Post randomization measure of Pr/Cr. The number of participants was determined by including only the individuals who satisfied the criteria.||Percent Change in Pr/Cr||95% Confidence Interval|Geometric Mean
852256|NCT00568178|Secondary|Double-Blind Treatment Phase: Change From Baseline in Diastolic Blood Pressure in Hypertensive Participants at Week 12||Baseline and Week 12|All-Participants-As-Treated population which included all randomized participants who received at least 1 dose of study therapy, and each participant was counted in the treatment group of the drug they actually received||mm Hg||95% Confidence Interval|Least Squares Mean
852257|NCT00568178|Secondary|Double-Blind Treatment Phase: Change From Baseline in Systolic Blood Pressure in Hypertensive Participants at Week 12||Baseline and Week 12|All-Participants-As-Treated population which included all randomized participants who received at least 1 dose of study therapy, and each participant was counted in the treatment group of the drug they actually received.||mm Hg||95% Confidence Interval|Least Squares Mean
852258|NCT00568178|Primary|Double-Blind Treatment Phase: Percent Change From Baseline in Urinary Protein/Creatinine (Pr/Cr) Ratio (gm/gm) at Week 12|"Change in urinary protein excretion, determined as urinary Pr/Cr ratio compared to baseline*, after approximately twelve weeks of treatment.
Baseline is defined as values obtained at Visit 3, Week (-1) during the Single Blind Run-in period."|Baseline and Week 12|Full Analysis Set included all randomized participants who took at least one dose of study drug and had baseline and post randomization measurements available||Percent Change in Pr/Cr||95% Confidence Interval|Geometric Mean
852259|NCT00560755|Secondary|Percentage of Participants Experiencing a Systemic AE After ProQuad® Dose 1|Systemic AEs were monitored for up to 28 days after the first ProQuad® injection.|Up to Day 28 (28 days after ProQuad® Dose 1)|All participants who received the first ProQuad® dose and had safety follow-up data available are included.||Percentage of Participants||95% Confidence Interval|Number
852260|NCT00560755|Secondary|Percentage of Participants With ≥ 1 Rectal Temperature Reading ≥ 38.0° C After ProQuad® Dose 1|The percentage of participants with at least 1 rectal temperature reading ≥ 38.0° C was determined.|Up to Day 28 (28 days after ProQuad® Dose 1)|All participants who received the first ProQuad® dose and had safety follow-up data available are included.||Percentage of Participants|||Number
852261|NCT00560755|Secondary|Percentage of Participants Experiencing a Unsolicited Injection-site AE After ProQuad® Dose 1|Unsolicited injection-site AEs were monitored for up to 28 days after the first ProQuad® injection.|Up to Day 28 (28 days after ProQuad® Dose 1)|All participants who received the first ProQuad® dose and had safety follow-up data available are included.||Percentage of Participants||95% Confidence Interval|Number
852262|NCT00560755|Secondary|Percentage of Participants Experiencing a Solicited Injection-site AE After ProQuad® Dose 1|The solicited injection-site AEs erythema, swelling, and pain were monitored for 4 days after administration of ProQuad® Dose 1.|From Day 1 to Day 4 (for 4 days following ProQuad® Dose 1)|All participants who received the first ProQuad® dose and had safety follow-up data available are included.||Percentage of Participants||95% Confidence Interval|Number
852263|NCT00560755|Primary|Percentage of Participants Experiencing a Vaccine-related SAE After ProQuad® Dose 2|Vaccine-related SAEs were defined as any untoward consequence that results in death, is life-threatening, requires hospitalization or prolongs existing hospitalization, is a congenital anomaly/birth defect, or is any other medically important event.|Up to Day 84 (up to 42 days after ProQuad® Dose 2)|All participants who received the first ProQuad® dose and had safety follow-up data available are included.||Percentage of Participants||95% Confidence Interval|Number
852264|NCT00560755|Primary|Percentage of Participants Experiencing a Serious AE (SAE) After ProQuad® Dose 2|Serious AEs ere defined as any untoward consequence that results in death, is life-threatening, requires hospitalization or prolongs existing hospitalization, is a congenital anomaly/birth defect, or is any other medically important event.|Up to Day 84 (up to 42 days after ProQuad® Dose 2)|All participants who received the first ProQuad® dose and had safety follow-up data available are included.||Percentage of Participants||95% Confidence Interval|Number
852265|NCT00560755|Primary|Percentage of Participants Experiencing a Mumps-like Illness After ProQuad® Dose 2|The percentage of participants experiencing a mumps-like illness for up to 28 days after the second ProQuad® injection was determined.|Up to Day 70 (up to 28 days after ProQuad® Dose 2)|All participants who received the second ProQuad® dose and had safety follow-up data available are included.||Percentage of Participants||95% Confidence Interval|Number
852266|NCT00560755|Primary|Percentage of Participants Experiencing a Non-injection-site Rash of Interest AE After ProQuad® Dose 2|Non-injection-site rashes of interest, including measles-like, rubella-like, varicella-like, and zoster-like rashes, were monitored for up to 28 days after the second ProQuad® injection.|Up to Day 70 (up to 28 days after ProQuad® Dose 2)|All participants who received the second ProQuad® dose and had safety follow-up data available are included.||Percentage of Participants||95% Confidence Interval|Number
852267|NCT00560755|Primary|Percentage of Participants Experiencing a Vaccine-related Systemic AE After ProQuad® Dose 2|Vaccine-related systemic AEs were monitored for up to 28 days after the second ProQuad® injection.|Up to Day 70 (up to 28 days after ProQuad® Dose 2)|All participants who received the second ProQuad® dose and had safety follow-up data available are included.||Percentage of Participants||95% Confidence Interval|Number
852268|NCT00560755|Primary|Percentage of Participants Experiencing a Systemic AE After ProQuad® Dose 2|Systemic AEs were monitored for up to 28 days after the second ProQuad® injection.|Up to Day 70 (up to 28 days after ProQuad® Dose 2)|All participants who received the second ProQuad® dose and had safety follow-up data available are included.||Percentage of Participants||95% Confidence Interval|Number
852269|NCT00560755|Primary|Percentage of Participants Experiencing a Injection-site Rash of Interest AE After ProQuad® Dose 2|Injection-site rashes of interest, including measles-like, rubella-like, and vesicular, were monitored for up to 28 days after the second ProQuad® injection.|Up to Day 70 (up to 28 days after ProQuad® Dose 2)|All participants who received the second ProQuad® dose and had safety follow-up data available are included.||Percentage of Participants||95% Confidence Interval|Number
852270|NCT00560755|Primary|Percentage of Participants Experiencing a Unsolicited Injection-site AE After ProQuad® Dose 2|The percentage of participants experiencing a unsolicited injection-site AE(s) were monitored for up to 28 days after the second ProQuad® injection.|Up to Day 70 (up to 28 days after ProQuad® Dose 2)|All participants who received the second ProQuad® dose and had safety follow-up data available are included.||Percentage of Participants||95% Confidence Interval|Number
852271|NCT00560755|Primary|Percentage of Participants Experiencing a Solicited Injection-site AE After ProQuad® Dose 2|The solicited injection-site AEs erythema, swelling, and pain were monitored for 4 days after administration of ProQuad® Dose 2.|Up to Day 46 (for 4 days following ProQuad® Dose 2)|All participants who received the second ProQuad® dose and had safety follow-up data available are included.||Percentage of Participants||95% Confidence Interval|Number
852272|NCT00560755|Primary|Percentage of Participants Experiencing a Vaccine-related AE After ProQuad® Dose 2|The percentage of participants experiencing a vaccine-related AEs for up to 28 days after the second ProQuad® injection was determined.|Up to Day 70 (up to 28 days after ProQuad® Dose 2)|All participants who received the second ProQuad® dose and had safety follow-up data available are included.||Percentage of Participants||95% Confidence Interval|Number
852273|NCT00560755|Primary|Percentage of Participants Experiencing an Adverse Event (AE) After ProQuad® Dose 2|The percentage of participants experiencing an AE(s) for up to 28 days after the second ProQuad® injection was determined.|Up to Day 70 (up to 28 days after ProQuad® Dose 2)|All participants who received the second ProQuad® dose and had safety follow-up data available are included.||Percentage of Participants||95% Confidence Interval|Number
852274|NCT00499746|Secondary|Peak Change From Baseline Stimulant Effects Assessed by the Visual Analog Scale (VAS)|"The Visual Analog Scale (VAS) measures subjective ratings of stimulant effects. The scale on this measure ranges from 0 being Not at all to 100 being Extremely. On this scale, higher scores indicate a stronger drug effect. The outcome measure illustrates a difference from peak (120 min) to baseline measure."|Measure at 120 min after drug administration|||units on a scale||Standard Error|Mean
852275|NCT00499746|Secondary|Peak Change From Baseline Opioid Agonist Effects Assessed by the Visual Analog Scale (VAS)|"The Visual Analog Scale (VAS) measures subjective ratings of opioid agonist effects. The scale on this measure ranges from 0 being Not at all to 100 being Extremely. On this scale, higher scores indicate a stronger drug effect. The outcome measure illustrates a difference from peak (120 min) to baseline measure on VAS."|Measure at 120 min after drug administration|||units on a scale||Standard Error|Mean
852276|NCT00499746|Secondary|Physiological Effects Assessed by Peak Change From Baseline Pupil Diameter|Change in pupil diameter (mm) at peak (120 min) compared to baseline measure of pupil diameter|Measure at 120 min after drug administration|||mm||Standard Error|Mean
852277|NCT00499746|Secondary|Physiologic Effects Assessed by the Pharmacological Class Questionnaire|"During the peak (assessed at 120 min) of each drug administration, participants were asked to complete the pharmacological class questionnaire. The pharmacological class questionnaire had volunteers indicate which drug class was most similar to the drug condition they received. Ten drug classes were listed with descriptive labels and examples of each: placebo, opiates (or opioid agonist), phenothiazines, barbiturates, antidepressants, opiate antagonists, hallucinogens, benzodiazepines, stimulants, and other. Of these choices, participants chose 3: placebo, opioid agonist, and stimulant.
The outcome measure represents the percentage of participants who chose either placebo, opioid agonist, or stimulant across each drug condition."|Measure at 120 min after drug administration|||percentage of drug identification|||Number
852278|NCT00499746|Primary|Discrimination Effects Assessed by Discrete Choice|"During discrete choice, volunteers were given three choices (placebo, hydromorphone, methylphenidate) and were asked to choose which of the training drugs they thought they received. The outcome measure illustrates the percentage of participants who chose either placebo, hydromorphone, or methylphenidate during each drug condition (i.e., Placebo, Hydromorphone 8 mg, Tramadol 50 mg, etc.), ranging from 0-100.
The outcome measure represents the percentage of participants who chose either placebo, opioid agonist, or stimulant across each drug condition."|1 day|||percentage of drug identification|||Number
852279|NCT00499746|Primary|Discrimination Effects Assessed by Point Distribution|In point distribution, volunteers distributed 50 points among three training drug letters depending on how certain they were of the identity of the administrated drug. Maximum total is 50 points.|1day|||Points distributed||Standard Error|Mean
852280|NCT00499746|Primary|Discrimination Effects Assessed by Operant Responses|Volunteers emitted operant responses on computer keys that corresponded to the training letter, on a fixed interval 1 second schedule for 8.5 minutes. The range is from 0 to 500 operant responses.|1 day|||Responses||Standard Error|Mean
852281|NCT00499746|Primary|Acquisition of Discrimination Assessed by Accuracy of the Discrimination Test|The acquisition of discrimination was to test whether volunteers could identify each training drug condition by the correct letter code. Results are the percentage of correct responses with a range of 0% to 100%.|1 day|||percent of correct response||Full Range|Mean
852323|NCT00081939|Primary|Percentage of Participants With Progression-Free Survival (PFS) at 3 Years From Initiation of Study Treatment|In patients with no confirmed Partial Response, Near Complete Response, or Complete Response, progression was defined as a >25% increase from baseline in myeloma protein production or other signs of disease progression such as hypercalcemia, etc.|3 years|||percentage of participants|||Number
852327|NCT00068406|Primary|Treatment-Related Adverse Effects (Grade 3 or Higher) During Study Treatment Period|Number of participants with a maximum grade of 3 or higher during the treatment period. Adverse events are graded and categorized using Common Terminology Criteria for Adverse Events Version 2.0|Assessed every cycle while on treatment, 30 days after the last cycle of treatment. Up to eleven weeks from the start of study treatment|Eligible and treated patients||Participants|||Number
852328|NCT00068406|Primary|Complete Clinical and Pathologic Response|Complete clinical and pathologic response is defined as the disappearance of all gross tumor during chemoradiation with no residual tumor present in the surgical specimen.|Seven weeks after initiating treatment for clinical response and up to fifteen weeks for assessment of pathologic response.|Eligible and treated patients||Percentage of Participants||90% Confidence Interval|Number
852355|NCT00016718|Primary|Proportion of Participants With Suppression of HIV Viral Load to Less Than 50 Copies/ml at Week 16|Proportion was calculated as number of participants with HIV-1 RNA <= 50 copies/ml relative to the number of participants with HIV-1 RNA measured at that time point.|At week 16|All Participant who enrolled in the study and with available HIV-RNA at week 16||proportion of participants||95% Confidence Interval|Number
852356|NCT00016718|Primary|Proportion of Participants With Suppression of HIV Viral Load to Less Than 400 Copies/ml at Week 16|Proportion was calculated as number of participants with HIV-1 RNA <= 400 copies/ml relative to the number of participants with HIV-1 RNA measured at that time point.|At week 16|All Participant who enrolled in the study and with available HIV-RNA at week 16||proportion of participants||95% Confidence Interval|Number
852357|NCT00016718|Primary|Proportion of Participants Who Developed Grade 3 or 4 Adverse Events Attributed to the Study Treatment.|"Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004, Clarification August 2009, which is available on the RCC website at (http://rcc.tech-res.com/). Adverse Events of Grade 3 or 4 laboratory abnormalities or signs and symptoms that were judged by the study team to be possibly or probably related to the study treatment.
Comparisons between age groups were not required as per protocol."|At study entry, weeks 2 and 4, every 4 weeks up to week 96 and every 6 weeks thereafter for Group 1 participants and at study entry, weeks 2 and 4, every 4 weeks up to week 144 and every 12 weeks thereafter for Groups 2 and 3|All Participant who enrolled in the study||proportion of participants||95% Confidence Interval|Number
852362|NCT02609659|Secondary|Percentage of Participants With Post-treatment Relapse|Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug, excluding reinfection, among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment.|From the end of treatment through 12 weeks after the last dose of study drug|All participants who received at least 1 dose of study drug, completed treatment, and had HCV RNA <LLOQ at the final treatment visit.||percentage of participants|||Number
852363|NCT02609659|Secondary|Percentage of Participants With On-treatment Virologic Failure|On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; or all on-treatment values of HCV RNA ≥ LLOQ with at least 6 weeks of treatment.|Up to 12 weeks|All participants who received at least 1 dose of study drug (ITT population).||percentage of participants|||Number
852364|NCT02609659|Primary|Mean Change in Hemoglobin Values From Baseline to End of Treatment|The mean change in hemoglobin (g/L) from baseline to each study visit and to the final treatment visit (up to 12 weeks) is provided.|Baseline (Day 1) to Weeks 2, 4, 8, and 12, and the Final Treatment Visit (up to 12 weeks)|All participants who received at least 1 dose of study drug (ITT population) with a hemoglobin value at baseline and at given timepoint.||g/L||Standard Deviation|Mean
852365|NCT02609659|Primary|Percentage of Participants With Hemoglobin < 10 g/dL During Treatment|The percentage of participants with hemoglobin <10 g/dL during treatment is provided.|up to 12 weeks|All participants who received at least 1 dose of study drug (ITT population) with at least one post-baseline hemoglobin value through the final treatment value.||percentage of participants|||Number
852366|NCT02609659|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug. The primary efficacy endpoint was noninferiority of the percentage of participants who achieved SVR12 in participants in the treatment arm 3-DAA + RBV 600 mg) for 12 weeks compared with the historical control rate for subjects treated with 3-DAA + weight-based RBV for 12 weeks.|12 weeks after the last actual dose of study drug|Intent-to-treat population: all participants who received at least 1 dose of study drug; participants with missing data after flanking imputation were counted as nonresponders.||percentage of participants||95% Confidence Interval|Number
852390|NCT02475395|Secondary|Number of Accurate and Inaccurate Results Obtained by Healthcare Professionals Performing Trak Assays on Subjects' Samples.|Healthcare professions obtained a categorical sperm concentration result by performing assay on aliquot obtained from Lay User's sample. Positive (for subfertility) results are less than or equal to 15 M/mL threshold. Reference result using gold standard (CASA) was measured and compared to Trak. True positive and true negative matched Reference category result and false negative, false positive did not match reference category result.|Participants will be followed for one visit for up to 2 hours|One fewer was analyzed in this population because a sample did not have enough sample to allow the HCP to run the test.||Participants|||Count of Participants
852391|NCT02475395|Secondary|Number of Accurate and Inaccurate Subfertility Results as Obtained by Healthcare Professionals Observing Assays Result Performed by Untrained Lay Users.|Healthcare professions obtained a categorical sperm concentration result by observing completed assay outputs as performed by Lay Users. Positive (for subfertility) results are less than or equal to 15 M/mL threshold. Reference result using gold standard (CASA) was measured and compared to Trak. True positive and true negative matched Reference category result and false negative, false positive did not match reference category result.|Participants will be followed for one visit for up to 2 hours|||Participants|||Count of Participants
852392|NCT02475395|Primary|Number of Untrained Lay Users That Obtained Accurate and Inaccurate Subfertility Results From the TRAK Device When Compared to Results Obtained From the Gold Standard|Lay users obtained categorical sperm concentration result. Positive (for subfertility) results are less than or equal to 15 M/mL threshold. Gold standard reference (analysis by Computer-aided Semen Analysis [CASA]) result was measured and compared to Trak. True positive and true negative matched Reference category result and false negative, false positive did not match gold standard reference category result.|Participants will be followed for one visit for up to 2 hours|||Participants|||Count of Participants
852393|NCT02450383|Secondary|Wound Healing, Measured Using a Standardized Visual Wound Healing Index|Wound healing status was evaluated by the same calibrated clinician using a standardized visual wound healing index at different time points A simple wound healing scoring system including 3 categories was used: 1- uneventful wound healing, 2- slight gingival edema, erythema or discomfort, 3- poor wound healing|2 weeks|||units on a scale||Standard Deviation|Mean
852394|NCT02450383|Secondary|Patient-perceived Discomfort, Measured by VAS|Patient-reported outcome measures of perceived discomfort using a visual analog scale (VAS) from 0 (no pain) to 100 (maximum pain) were recorded|2 weeks|||units on a scale||Standard Deviation|Mean
852395|NCT02450383|Secondary|Changes in Peri-implant Keratinized Mucosa Width (Apico-coronal) at 16 Weeks After Surgery||Baseline to 16 weeks after baseline|||millimeters||Standard Deviation|Mean
852396|NCT02450383|Primary|Change in Buccal Peri-implant Mucosa Thickness Between Baseline and 16 Weeks After Surgery|Buccal mucosa thickness measurements were obtained by a calibrated, masked examiner using a custom-made stent and an endo file for precision and reproducibility between different time points|Baseline and 16 weeks after baseline|||millimeters||Standard Deviation|Mean
852400|NCT02419521|Secondary|Cardiac Death and TVMI||8 Months|||Participants|||Count of Participants
852401|NCT02419521|Secondary|Stent Thrombosis (ST)||8 Months|||Participants|||Count of Participants
852402|NCT02419521|Secondary|Target Vessel Failure (TVF)||8 Months|||Participants|||Count of Participants
852403|NCT02419521|Secondary|Target Lesion Failure (TLF)||8 Months|||Participants|||Count of Participants
852404|NCT02419521|Secondary|Major Adverse Cardiac Event (MACE)|Defined as death, myocardial infarction (Q wave and non-Q wave), emergent coronary bypass surgery, or clinically-driven repeat target lesion revascularization by percutaneous or surgical methods|8 Months|||Participants|||Count of Participants
852405|NCT02419521|Secondary|Target Lesion Revascularization (TLR)||8 Months|||Participants|||Count of Participants
852406|NCT02419521|Secondary|Target Vessel Myocardial Infarction (TVMI)||8 Months|||Participants|||Count of Participants
852407|NCT02419521|Secondary|Cardiac Death||8 Months|||Participants|||Count of Participants
852408|NCT02419521|Primary|In-stent Late Lumen Loss as Measured by Quantitative Coronary Angiography|In-stent late lumen loss at 8-months post-procedure as measured by quantitative coronary angiography|8 Months|||mm||Standard Deviation|Mean
852530|NCT02207803|Primary|Zarit Burden Interview|22-item measure of caregiver self-reported burden. Response options for each item range from 0-4, and total scores range from 0-88, with higher scores indicating greater self-reported burden. Only total scores are reported here.|2 months post-hospital discharge|Data are from caregivers only, hence not the full sample.||units on a scale||Standard Deviation|Mean
852529|NCT02207803|Secondary|Exemplary Care Scale-Provide Subscale|4-item measure of the patient's report of the quality of care they receive from their caregiver. Response options for each item range from 1-4, and total scores range from 4-16, with higher scores indicating a higher quality of informal care received. Only Provide subscale scores of the Exemplary Care Scale are reported here.|2 months post-hospital discharge|This is patient-report only at post-test, hence it does not use the full sample.||units on a scale||Standard Deviation|Mean
852601|NCT02102464|Other Pre-specified|Mean Change in Comfortable Contact Lens Wear Time From Baseline at 1 Month|Subjects reported how long they wore their contact lenses per day (total contact lens wear time) and how long the contact lenses were comfortable (comfortable contact lens wear time). The mean change in comfortable contact lens wear time from Baseline was also evaluated at 1 Month post-LipiFlow treatment for the LipiFlow and Crossover LipiFlow Groups. The LipiFlow Group was assessed at the 1-Month visit. The Crossover LipiFlow Group was assessed at the 4-Month visit (one month after receiving cossover LipiFlow treatment). There was no planned statistical analysis comparison between the LipiFlow and Crossover LipiFlow groups at 1 Month.|1 Month|Intent to Treat (all randomized subjects)||hours per day|Eyes|95% Confidence Interval|Mean
852602|NCT02102464|Other Pre-specified|Mean Change in Dry Eye Questionnaire From Baseline at 1 Month|The mean change in dry eye symptoms from Baseline based on the SPEED questionnaire score was also evaluated at 1 Month post-LipiFlow treatment for the LipiFlow and Crossover LipiFlow Groups. The LipiFlow Group was assessed at the 1-Month visit. The Crossover LipiFlow Group was assessed at the 4-Month visit (one month after receiving cossover LipiFlow treatment). There was no planned statistical analysis comparison between the LipiFlow and Crossover LipiFlow groups at 1 Month. Dry eye symptoms evaluated were dryness, grittiness or scratchiness; soreness or irritation; burning or watering; and eye fatigue. Symptom frequency and severity were assessed. The SPEED score is the sum of frequency and severity scores with a range from 0 to 28. A lower SPEED score represents less frequent and/or less severe symptoms.|1 Month|Intent to Treat (All randomized subjects)||units on a scale|Eyes|95% Confidence Interval|Mean
852603|NCT02102464|Other Pre-specified|Mean Change in Meibomian Gland Score From Baseline at 1 Month|The mean change in meibomian gland score from Baseline was also evaluated at 1 Month post-LipiFlow treatment for the LipiFlow and Crossover LipiFlow Groups. The LipiFlow Group was assessed at the 1-Month visit. The Crossover LipiFlow Group was assessed at the 4-Month visit (one month after receiving crossover LipiFlow treatment). There was no planned statistical analysis comparison between the LipiFlow and Crossover LipiFlow groups at 1 Month. To determine the meibomian gland score, secretion characteristics of 15 meibomian glands along the lower eyelid were evaluated including five glands each in the temporal, central and nasal regions of the lower eyelid. For each gland, secretion characteristics were graded as 3 (clear liquid), 2 (cloudy liquid), 1 (inspissated/ toothpaste consistency) and 0 (no secretion). The total meibomian gland score is the sum of the grades for all 15 glands with a range between 0 and 45. A higher score reflects less meibomian gland dysfunction.|1 Month|Intent to Treat (All randomized subjects)||units on a scale|Eyes|95% Confidence Interval|Mean
852604|NCT02102464|Other Pre-specified|Mean Change in Comfortable Contact Lens Wear Time From Baseline at 3 Months|Subjects reported how long they wore their contact lenses per day (total contact lens wear time) and how long the contact lenses were comfortable (comfortable contact lens wear time). A pre-specified exploratory analysis was to compare the mean change in comfortable contact lens wear time between Baseline and 3 Months for the LipiFlow group vs. untreated control.|3 Months|Intent to Treat (ITT) of all randomized subjects||hours per day||95% Confidence Interval|Mean
852605|NCT02102464|Secondary|Mean Change in Dry Eye Questionnaire Score From Baseline at 3 Months|The Secondary Endpoint was intended to assess for reduction in dry eye symptoms in symptomatic contact lens after LipiFlow treatment in comparison to an untreated control using the Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire. The Secondary Endpoint was defined as the mean change in SPEED score in the LipiFlow Treatment group compared to Untreated Control group from Baseline to 3 Months. Dry eye symptoms evaluated were dryness, grittiness or scratchiness; soreness or irritation; burning or watering; and eye fatigue. Symptom frequency and severity were assessed. The SPEED score is the sum of frequency and severity scores with a range from 0 to 28. A lower SPEED score represents less frequent and/or less severe symptoms.|3 Months|Intent to Treat (ITT) Population of all randomized subjects.||units on a scale||95% Confidence Interval|Mean
852606|NCT02102464|Primary|Mean Change in Meibomian Gland Score From Baseline at 3 Months|The Primary Endpoint was intended to assess for improvement in meibomian gland function in symptomatic contact lens wearers after LipiFlow treatment in comparison to an untreated control.The Primary Endpoint was defined as the mean change in meibomian gland score in the LipiFlow Treatment group compared to Untreated Control group from Baseline to 3 Months. To determine the meibomian gland score, secretion characteristics of 15 meibomian glands along the lower eyelid were evaluated including five glands each in the temporal, central and nasal regions of the lower eyelid. For each gland, secretion characteristics were graded as 3 (clear liquid), 2 (cloudy liquid), 1 (inspissated/ toothpaste consistency) and 0 (no secretion). The total meibomian gland score is the sum of the grades for all 15 glands with a range between 0 and 45. A higher score reflects less meibomian gland dysfunction.|3 Months|Intent to Treat (ITT) Population of all randomized subjects.||units on a scale|Eyes|95% Confidence Interval|Mean
852723|NCT01916967|Secondary|Change From Baseline in the Rash Score Assessed by Investigator at Day 3, Week 1 and Week 2|The Investigator assessed the severity of participant rash (erythema: 0=no symptom to 3=intensive redness, and wheal: 0=no symptom to 3=significant ridge). The sum score for erythema plus wheal could range from 0 to 6, with a higher score indicating greater severity. The changes from Baseline in the sum score for erythema plus wheal at the Day 3, Week 1 and Week 2 clinic visits were calculated.|Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit|The FAS population consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post-Baseline assessment for this outcome measure.||Score on a Scale||95% Confidence Interval|Least Squares Mean
852694|NCT01986686|Secondary|Recurrence and Treatment|Data will be collected on recurrence and treatment for recurrent diverticulitis|2 years||||||
852695|NCT01986686|Secondary|Post Operative Complications|Data will be collected on percent and type of complications for the surgery arm.|30 days||||||
852696|NCT01986686|Secondary|Readmission|Data will be collected on percent of patients who are readmitted for recurrence or postoperative complications during the follow-up period after enrollment.|30 days||||||
852697|NCT01986686|Secondary|Mortality|Data will be collected on percent of patients who die during the follow-up period after enrollment.|4 years||||||
852698|NCT01986686|Secondary|Measure Length of Hospital Stay for Surgery vs Non Surgery Patients|Data collected will include length of hospital stay from the date of admission to discharge day for nonoperative management of the first episode of Hinchey II diverticulitis.|4 years||||||
852699|NCT01986686|Primary|Primary Study Endpoint|The primary outcome measure is recurrent diverticulitis of the colon defined as an acute episode confirmed at CT scan and requiring hospitalization with IV antibiotics.|Minimum of 1 year after enrollment|||Participants|||Count of Participants
852706|NCT01956435|Secondary|Subject Self-reported Assessment of Re-pigmentation for Treated Lesions|"Subject reported level of re-pigmentation for treated lesions was assessed by improvement from baseline using the following scale:
1 = Worsening of the light spots that were treated (the light spots seem to have gotten lighter or I have more light spots in the areas that were treated); 2 = No Improvement of the light spots (light spots have not changed since starting this study); 3 = Mild improvement of the light spots (there is some darkening of the light spots, but not in more than half of them); 4 = Moderate improvement (there is some darkening of the light spots in more than half of the light spots, but not more than 75% of them)."|12 weeks|healthy adult patients with bilateral IGH lesions on lower extremities||units on a scale||Standard Deviation|Mean
852707|NCT01956435|Primary|Efficacy Outcome|Effectiveness will be graded by the blinded observer scal via photographic comparisons at the end of the study. Efficacy was assessed by improvement from baseline using the following scale: -1 = Worsening of IGH; 0 = No Improvement (IGH remained stable); 1 = Mild improvement of IGH (some re-pigmentation on <50% IGH); 2 = Moderate improvement (some re-pigmentation on >50% or full re-pigmentation on <75% IGH); 3 = Full re-pigmentation on >75% IGH.|12 weeks|healthy adult patients with bilateral IGH lesions on lower extremities||units on a scale||95% Confidence Interval|Mean
852718|NCT01916967|Secondary|Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score Reported by Participants at Week 1 and Week 2|The DLQI is a 10-item questionnaire that measures how much participant skin problems have affected their life. Responses to questions about the effect of participant skin problems on life ranged from 0=Not at all to 3=Very much. The DLQI is broken down into 6 subscales: Symptoms and feelings (range 0-6), Daily activities (range 0-6), Leisure (range 0-6), Work and school (range 0-3), Personal relationships (range 0-6), and Treatment (range 0-3). DLQI subscales were summed to yield the DLQI total score, which could range from 0 to 30. For both DLQI subscales and DLQI total score, a higher score indicated a greater negative impact on life. Participants >=16 years of age completed the DLQI questionnaire about the condition of their skin over the previous week. The changes from Baseline in the DLQI total score at the Week 1 and Week 2 clinic visits were calculated.|Baseline Visit and Week 1 Visit, Week 2 Visit|The FAS population consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post-Baseline assessment for DLQI||Score on a Scale||95% Confidence Interval|Least Squares Mean
852719|NCT01916967|Secondary|Change From Baseline in the Rash Score Reported in Participant Diaries at Day 3, Week 1 and Week 2|Participants assessed the severity of their rash (erythema: 0=no symptom to 3=intensive redness, and wheal: 0=no symptom to 3=significant ridge). The sum score for erythema plus wheal could range from 0 to 6, with a higher score indicating greater severity. The changes from Baseline in the sum score for erythema plus wheal at the Day 3, Week 1 and Week 2 clinic visits were calculated.|Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit|The FAS population consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post-Baseline assessment for this outcome measure.||Score on a Scale||95% Confidence Interval|Least Squares Mean
852720|NCT01916967|Secondary|Change From Baseline in Pruritus/Itch on a Visual Analog Scale (VAS) Reported by Participants at Day 3, Week 1 and Week 2|Participants assessed the degree of their pruritus/itching using a 100-mm visual analog scale (VAS) (0 mm=No itch to 100 mm=Worst imaginable itch), with a higher score indicating more severe itching. The changes from Baseline in participant-assessed pruritus/itch at the Day 3, Week 1 and Week 2 clinic visits were calculated.|Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit|The FAS population consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post-Baseline assessment for this outcome measure.||Score on a Scale||95% Confidence Interval|Least Squares Mean
852721|NCT01916967|Secondary|Change From Baseline in the Pruritus/Itch Score Reported in Participant Diaries at Day 3, Week 1 and Week 2|Participants assessed the severity of their pruritus/itch during the daytime and nighttime (0=asymptomatic to 4=severe). The sum of the daytime and nighttime pruritus/itch scores could range from 0 to 8, with a higher score indicating greater severity. The changes from Baseline in the sum of the daytime and nighttime scores at the Day 3, Week 1 and Week 2 clinic visits were calculated.|Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit|The FAS population consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post-Baseline assessment for this outcome measure.||Score on a Scale||95% Confidence Interval|Least Squares Mean
852722|NCT01916967|Secondary|Number of Participants With a Moderate or Remarkable Improvement in the Global Improvement Rate of Both Pruritus/Itch and Rash (Erythema and Wheal) Assessed by the Investigator at Day 3, Week 1 and Week 2|The global improvement judgment criteria were used to assess overall improvement in pruritus/itch and rash. The Investigator assessed participant global improvement according to 5 grades (Grade 1=Remarkable improvement to Grade 5=Aggravated). The number of participants with moderate or remarkable improvements was calculated. Remarkable improvement (Grade 1) was defined as both pruritus/itch and rash (erythema and wheal) disappeared, or pruritus/itch disappeared and rash (erythema and wheal) was apparently improved. Moderate improvement (Grade 2) was defined as both pruritus/itch and rash (erythema and wheal) were greatly improved.|Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit|The FAS population consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post-Baseline assessment for this outcome measure.||Participants|||Number
852724|NCT01916967|Secondary|Change From Baseline in the Pruritus/Itch Score Assessed by Investigator at Day 3, Week 1 and Week 2|The Investigator assessed the severity of participant pruritus/itch during the daytime and nighttime (0=Asymptomatic to 4=Severe). The sum of the daytime and nighttime pruritus/itch scores could range from 0 to 8, with a higher score indicating greater severity. The changes from Baseline in the sum of the daytime and nighttime scores at the Day 3, Week 1 and Week 2 clinic visits were calculated.|Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit|The FAS population consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post-Baseline assessment for this outcome measure.||Score on a Scale||95% Confidence Interval|Least Squares Mean
852725|NCT01916967|Secondary|Change From Baseline in the Sum Score of Pruritus/Itch and Rash Assessed by Investigator at Day 3 and Week 1|The Investigator assessed the severity of participant pruritus/itch during the daytime (0=Virtually no itching to 4=Cannot relax because of constant itching) and nighttime (0=Virtually no itching to 4=Cannot sleep because of itching). The score used for pruritus/itch was the higher of the day or night scores (0=Asymptomatic to 4=Severe). The Investigator also assessed the severity of participant rash using the overall rash score (0=No rash to 3=Looks very bad). The sum of the pruritus/itch score (0-4) and rash score (0-3) could range from 0 to 7, with a higher sum score indicating greater severity. The changes from Baseline in the sum of the pruritus/itch and overall rash scores at the Day 3 and Week 1 clinic visits were calculated.|Baseline Visit and Day 3 Visit, Week 1 Visit|The FAS population consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post-Baseline assessment for this outcome measure.||Score on a Scale||95% Confidence Interval|Least Squares Mean
852726|NCT01916967|Primary|Number of Participants Who Discontinued Study Drug Due to an AE|An AE is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug, is also an AE.|Up to 2 weeks|The Safety Population consisted of all participants who received at least one dose of study drug. One Placebo group participant took the wrong study drug. This participant was analyzed separately.||Participants|||Number
852727|NCT01916967|Primary|Number of Participants Who Experienced at Least One Adverse Event (AE)|An AE is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug, is also an AE.|Up to 4 weeks (Up to 2 weeks after last dose of study drug)|The Safety Population consisted of all participants who received at least one dose of study drug. One Placebo group participant took the wrong study drug. This participant was analyzed separately.||Participants|||Number
852728|NCT01916967|Primary|Change From Baseline in the Sum Score of Pruritus/Itch and Rash Assessed by Investigator at Week 2|The Investigator assessed the severity of participant pruritus/itch during the daytime (0=Virtually no itching to 4=Cannot relax because of constant itching) and nighttime (0=Virtually no itching to 4=Cannot sleep because of itching). The score used for pruritus/itch was the higher of the day or night scores (0=Asymptomatic to 4=Severe). The Investigator also assessed the severity of participant rash using the overall rash score (0=No rash to 3=Looks very bad). The sum of the pruritus/itch score (0-4) and rash score (0-3) could range from 0 to 7, with a higher sum score indicating greater severity. The change from Baseline in the sum of the pruritus/itch and overall rash scores at the Week 2 clinic visit was calculated.|Baseline Visit and Week 2 Visit|The Full Analysis Set (FAS) population consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and a Week 2 assessment for this outcome measure.||Score on a Scale||95% Confidence Interval|Least Squares Mean
852729|NCT01916980|Secondary|Change From Baseline in the Pruritus/Itch Visual Analog Scale (VAS) Score Recorded by Participants at Day 3, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 12|Participants assessed the degree of their pruritus using a 100-mm visual analog scale (VAS; 0mm=No itch, 100mm=Worst imaginable itch) at Baseline and subsequent clinic visits. Pruritus/itch VAS scores could range from 0 to 100, with a higher score indicating more severe pruritus/itching. The changes from Baseline in the VAS scores for pruritus/itch at the Day 3, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 12 clinic visits were calculated.|Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit, Week 4 Visit, Week 6 Visit, Week 8 Visit, Week 12 Visit|The FAS population consisted of all participants who received at least one dose of study drug and had a Baseline or at least one post-Baseline observation for participant-assessed pruritus/itch VAS score.||Score on a Scale||95% Confidence Interval|Least Squares Mean
852730|NCT01916980|Secondary|Percentage of Participants With Moderate or Remarkable Improvement in the Global Improvement Rate of Pruritus/Itch Assessed by the Investigator at Day 3, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 12|The global improvement judgment criteria were used to assess overall improvement in pruritus/itch. The Investigator assessed the degree of severity of pruritus/itch based on 5 grades (1=Remarkably improved to 5=Aggravated) at Baseline and subsequent clinic visits. The percentages of participants who were remarkably improved (Grade 1=Pruritus/itch disappeared) or moderately improved (Grade 2=Pruritus/itch was greatly improved) at the Day 3, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 12 clinic visits were calculated.|Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit, Week 4 Visit, Week 6 Visit, Week 8 Visit, Week 12 Visit|The FAS population consisted of all participants who received at least one dose of study drug and had a Baseline or at least one post-Baseline observation for Investigator-assessed Global Improvement.||Percentage of Participants|||Number
852742|NCT01854710|Primary|Maximum Effect of ADASUVE on Cardiac Repolarization (QTc Interval Duration) at the Maximum Clinical Dose Compared to Placebo|Time-matched differences in QTcI values between the maximum of the mean difference from baseline of the QTcI interval after time-matched placebo subtraction for ADASUVE treatment at 12 post-inhalation times.|Predose, 2 min, 1, 1.5 hr, 2 hr 2 min, 2 hr 5 min, 2.5, 3, 5, 8, 12, and 24 hr|QT population -- LSM and CI statistics were based on the individual (within subject) corrected differences between Adasuve and placebo exposures per ICH Guideline E14 for a thorough QT study.||msec||95% Confidence Interval|Least Squares Mean
852731|NCT01916980|Secondary|Change From Baseline in Pruritus/Itch Score (Sum of Daytime and Nighttime Scores) Assessed by the Investigator at Day 3, Week 1, Week 4, Week 6, Week 8 and Week 12|The Investigator assessed the severity of participant pruritus/itch during the daytime (0=Virtually no itching to 4=Cannot relax because of constant itching) and nighttime (0=Virtually no itching to 4=Cannot sleep because of itching). The sum of the daytime and nighttime pruritus/itch scores could range from 0 to 8, with a higher sum score indicating greater severity. The changes from Baseline in the sum of the daytime and nighttime pruritus/itch scores at the Day 3, Week 1, Week 4, Week 6, Week 8 and Week 12 clinic visits were calculated.|Baseline Visit and Day 3 Visit, Week 1 Visit, Week 4 Visit, Week 6 Visit, Week 8 Visit, Week 12 Visit|The FAS population consisted of all participants who received at least one dose of study drug and had a Baseline or at least one post-Baseline observation for Investigator-assessed pruritus/itch score.||Score on a Scale||95% Confidence Interval|Least Squares Mean
852732|NCT01916980|Primary|Percentage of Participants Who Discontinued Study Drug Due to an AE|An AE is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug is also an AE.|Up to 12 weeks|The APaT population consisted of all participants who received at least one dose of study drug.||Percentage of Participants|||Number
852733|NCT01916980|Primary|Percentage of Participants Who Experienced at Least One Adverse Event (AE)|An AE is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug is also an AE.|Up to 14 weeks (Up to 2 weeks after last dose dose of study drug)|The All-Participants-as-Treated (APaT) population consisted of all participants who received at least one dose of study drug.||Percentage of Participants|||Number
852734|NCT01916980|Primary|Change From Baseline in Pruritus/Itch Score (Sum of Daytime and Nighttime Scores) Assessed by the Investigator at Week 2|The Investigator assessed the severity of participant pruritus/itch during the daytime (0=Virtually no itching to 4=Cannot relax because of constant itching) and nighttime (0=Virtually no itching to 4=Cannot sleep because of itching). The sum of the daytime and nighttime pruritus/itch scores could range from 0 to 8, with a higher sum score indicating greater severity. The change from Baseline in the sum of the daytime and nighttime pruritus/itch scores at Week 2 clinic visit was calculated.|Baseline Visit and Week 2 Visit|The Full Analysis Set (FAS) population consisted of all participants who received at least one dose of study drug and had a Baseline or at least one post-Baseline observation for Investigator-assessed pruritus/itch score.||Score on a Scale||95% Confidence Interval|Least Squares Mean
852736|NCT01854710|Other Pre-specified|Maximum Effect of Moxifloxacin on Cardiac Repolarization (QTc Interval Duration) Compared to Placebo (Study Assay Sensitivity)|A thorough QT/QTc study may be considered to have demonstrated assay sensitivity if 1 or more of the lower 95% CI values exceeds 5 msec|Predose, 2 min, 1, 1.5 hr, 2 hr 2 min, 2 hr 5 min, 2.5, 3, 5, 8, 12, and 24 hr|QT population -- LSM and CI statistics were based on the individual (within subject) corrected differences between moxifloxacin and placebo exposures per ICH Guideline E14 for a thorough QT study.||msec||95% Confidence Interval|Least Squares Mean
852737|NCT01854710|Secondary|Subjects With QTcI Increase > 60 ms From Baseline|Numbers of Subjects with QTcI Increase > 60 ms From Baseline at any time point|Predose, 2 min, 1, 1.5 hr, 2 hr 2 min, 2 hr 5 min, 2.5, 3, 5, 8, 12, and 24 hr|QT population -- Comparisons were based on corrected differences between Adasuve and placebo (excluding moxifloxacin) exposure per ICH Guideline E14 for a thorough QT study.||Participants|||Count of Participants
852738|NCT01854710|Secondary|Subjects With QTcI Increase > 30 ms From Baseline|Numbers of Subjects with QTcI Increase > 30 ms from Baseline at any time point|Predose, 2 min, 1, 1.5 hr, 2 hr 2 min, 2 hr 5 min, 2.5, 3, 5, 8, 12, and 24 hr|QT population -- Comparisons were based on corrected differences between Adasuve and placebo (excluding moxifloxacin) exposure per ICH Guideline E14 for a thorough QT study.||Participants|||Count of Participants
852739|NCT01854710|Secondary|Subjects With QTcI > 480 ms|Numbers of Subjects with QTcI > 480 ms (or 500 ms) at any time point|Predose, 2 min, 1, 1.5 hr, 2 hr 2 min, 2 hr 5 min, 2.5, 3, 5, 8, 12, and 24 hr|QT population -- Comparisons were based on corrected differences between Adasuve and placebo (excluding moxifloxacin) exposure per ICH Guideline E14 for a thorough QT study.||Participants|||Count of Participants
852740|NCT01854710|Secondary|Subjects With QTcI > 450 ms|Numbers of Subjects with QTcI > 450 ms at any time point|Predose, 2 min, 1, 1.5 hr, 2 hr 2 min, 2 hr 5 min, 2.5, 3, 5, 8, 12, and 24 hr|QT population -- Comparisons were based on corrected differences between Adasuve and placebo (excluding moxifloxacin) exposure per ICH Guideline E14 for a thorough QT study.||Participants|||Count of Participants
852741|NCT01854710|Secondary|QTc Versus Loxapine Concentration|QTc @ Cmax based on linear and nonlinear regression of QTcI versus time matched serum loxapine concentrations|Predose, 2 min, 1, 1.5 hr, 2 hr 2 min, 2 hr 5 min, 2.5, 3, 5, 8, 12, and 24 hr|QT population -- LSM and CI statistics were based on the individual (within subject) corrected differences between Adasuve and placebo exposures per ICH Guideline E14 for a thorough QT study.||msec||95% Confidence Interval|Least Squares Mean
852756|NCT01819311|Secondary|Screen for Child Anxiety Related Emotional Disorders - Child Version|The Screen for Child Anxiety Related Emotional Disorders - Child Version (SCARED-C) assesses anxiety symptom severity in youth ages 6-17 years. The child rates his or her anxiety symptoms on 41 items; each item is rated from 0 to 2. Total scores range from 0 to 82, with higher scores indicating greater anxiety severity.|8-week follow-up|||units on a scale||Standard Deviation|Mean
852757|NCT01819311|Secondary|Screen for Child Anxiety Related Emotional Disorders - Parent Version|The Screen for Child Anxiety Related Emotional Disorders - Parent Version (SCARED-P) assesses anxiety symptom severity in youth ages 6-17 years. The parent rates youth anxiety symptoms on 41 items; each item is rated from 0 to 2. Total scores range from 0 to 82, with higher scores indicating greater anxiety severity.|8-week follow-up|||units on a scale||Standard Deviation|Mean
852758|NCT01819311|Secondary|Screen for Child Anxiety Related Emotional Disorders - Child Version|The Screen for Child Anxiety Related Emotional Disorders - Child Version (SCARED-C) assesses anxiety symptom severity in youth ages 6-17 years. The child rates his or her anxiety symptoms on 41 items; each item is rated from 0 to 2. Total scores range from 0 to 82, with higher scores indicating greater anxiety severity.|post-treatment (within one week of completing the final of 8 semi-weekly sessions of Attention Bias Modification)|||units on a scale||Standard Deviation|Mean
852759|NCT01819311|Secondary|Screen for Child Anxiety Related Emotional Disorders - Parent Version|The Screen for Child Anxiety Related Emotional Disorders - Parent Version (SCARED-P) assesses anxiety symptom severity in youth ages 6-17 years. The parent rates youth anxiety symptoms on 41 items; each item is rated from 0 to 2. Total scores range from 0 to 82, with higher scores indicating greater anxiety severity.|post-treatment (within one week of completing the final of 8 semi-weekly sessions of Attention Bias Modification)|||units on a scale||Standard Deviation|Mean
852760|NCT01819311|Primary|Clinician Rating on the Pediatric Anxiety Rating Scale|The Pediatric Anxiety Rating Scale (PARS) assesses global anxiety severity across social anxiety disorder, separation anxiety disorder, and generalized anxiety disorder in youth ages 6-17 years. An independent evaluator rates anxiety symptoms on 7 dimensions (i.e., number of symptoms, severity of distress, severity of physical symptoms, frequency, avoidance, interference at home, and interference out of home). Each dimension is rated from 0 to 5. Total scores range from 0 to 35, with higher scores indicating greater anxiety severity.|8-week follow-up|||units on a scale||Standard Deviation|Mean
852761|NCT01819311|Primary|Clinician Rating on the Pediatric Anxiety Rating Scale|The Pediatric Anxiety Rating Scale (PARS) assesses global anxiety severity across social anxiety disorder, separation anxiety disorder, and generalized anxiety disorder in youth ages 6-17 years. An independent evaluator rates anxiety symptoms on 7 dimensions (i.e., number of symptoms, severity of distress, severity of physical symptoms, frequency, avoidance, interference at home, and interference out of home). Each dimension is rated from 0 to 5. Total scores range from 0 to 35, with higher scores indicating greater anxiety severity.|post-treatment (within one week of completing the final of 8 semi-weekly sessions of Attention Bias Modification)|||units on a scale||Standard Deviation|Mean
852765|NCT01765530|Secondary|ETT Microbiology|For each patient a quantitative culture will be obtained from the ETT after extubation. Secretions will be retrieved from the ETT after CT scan and quantitative standard cultures will be performed. Microbial molecular diversity analysis and antibacterial resistance patterns will also be studied.|At extubation (An expected average of 5 days)|||Log colony form unit (CFU)/ mL||Standard Error|Mean
852766|NCT01765530|Primary|Percentage of Occlusion Assessed Using a High Definition Computed Tomography Imaging of the Extubated ETTs|The investigators will measure percentage of occlusion determined by the accumulation of secretion within the lumen of each ETT using a high definition Computed Tomography (CT) imaging of the extubated ETTs. The whole ETT will be analyzed through high-definition CT slices. 100% of occlusion means total occlusion of the lumen of the ETT and 0% means absence of any occlusion.|At extubation (An expected average of 5 days)|||percentage of occlusion||Standard Deviation|Mean
852845|NCT01732445|Primary|Best Overall Response Rate as Determined by International Working Group Criteria|Best overall response rate as determined by International Working Group criteria: An evaluable patient will be classified as a responder for the primary endpoint if the patient’s best overall response is CR, PR or CI (Clinical Improvement) as determined by International Working Group Criteria over all cycles of study treatment. The percentage of successes will be estimated by the number of successes (defined as complete response, partial response, or clinical improvement) divided by the total number of evaluable patients times 100. Confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.|Up to 2 years|||percentage of patients with CR, PR or CI||95% Confidence Interval|Number
852842|NCT01732445|Other Pre-specified|Patient-reported Symptoms Assessed Using the MPN-SAF, as Measured by the Percentage of Patients With a Decrease in MPN-SAF TSS Greater Than 50% From Baseline|Patient-reported symptoms will be described at each time point using the mean, confidence interval, median, and range. The Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) will be analyzed using published scoring algorithms. MPN-SAF includes 27 items scored on a scale of 0 to 10. The MPN-SAF Total Symptom Score (TSS) (range 0-100) was computed according to the published scoring algorithm. Higher scores represent worse symptom burden. The percentage of patients with a decrease in MPN-SAF TSS greater than 50% from baseline and 95% confidence interval are reported below.|Baseline to up to 2 years|||percentage of patients||95% Confidence Interval|Number
852843|NCT01732445|Secondary|Toxicity, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (v4)|"The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns within patient groups. In addition, we will review all adverse event data that is graded as 3, 4, or 5 and classified as either unrelated or unlikely to be related to study treatment in the event of an actual relationship developing. The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment are reported below."|Up to 2 years|||percentage of patients|||Number
852844|NCT01732445|Secondary|Survival Time|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier. The median and 95% confidence interval are reported below.|From registration to death due to any cause, assessed up to 2 years|||months||95% Confidence Interval|Median
852851|NCT01687712|Secondary|Number of Subjects With Detectable Specific Serum Binding to FSH by Surface Plasmon Resonance - Cycle 3|Measurement of the number of subjects with detectable specific serum binding to FSH by surface Plasmon resonance during Cycle 3.|Immunogenicity samples were taken at baseline, Visit 5 (8 days after start of treatment), Visit 9 (5 days after the end of FSH treatment), Visit 10 (18 +/- 1 days after oocyte retrieval), and Visit 11 (42 +/- 1 days after embryo transfer).|Safety population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization. Percentages are based on the number of subjects in the safety population with data at the respective visit.||Participants|||Count of Participants
852852|NCT01687712|Secondary|Number of Subjects With Detectable Specific Serum Binding to FSH by Surface Plasmon Resonance - Cycle 2|Measurement of the number of subjects with detectable specific serum binding to FSH by surface Plasmon resonance during Cycle 2.|Immunogenicity samples were taken at baseline, Visit 5 (8 days after start of treatment), Visit 9 (5 days after the end of FSH treatment), Visit 10 (18 +/- 1 days after oocyte retrieval), and Visit 11 (42 +/- 1 days after embryo transfer).|Safety population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization. Percentages are based on the number of subjects in the safety population with data at the respective visit.||Participants|||Count of Participants
852853|NCT01687712|Secondary|Number of Subjects With Detectable Specific Serum Binding to FSH by Surface Plasmon Resonance - Cycle 1|Measurement of the number of subjects with detectable specific serum binding to FSH by surface Plasmon resonance during Cycle 1.|Immunogenicity samples were taken at baseline, Visit 5 (8 days after start of treatment), Visit 9 (5 days after the end of FSH treatment), Visit 10 (18 +/- 1 days after oocyte retrieval), and Visit 11 (42 +/- 1 days after embryo transfer).|Safety population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization. Percentages are based on the number of subjects in the safety population with data at the respective visit.||Participants|||Count of Participants
852854|NCT01687712|Secondary|Adverse Events of Special Interest: Ovarian Hyperstimulation Syndrome (OHSS) - Cycle 3|Summary of the number of subjects with mild, moderate and severe OHSS. The total number of subjects with OHSS is also included.|Measured either 3 days after ooctye pick up (Visit 9) or 18 +/- 1 days after oocyte pick up (Visit 10).|Safety population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.||Participants|||Count of Participants
852855|NCT01687712|Secondary|Adverse Events of Special Interest: Ovarian Hyperstimulation Syndrome (OHSS) - Cycle 2|Summary of the number of subjects with mild, moderate and severe OHSS. The total number of subjects with OHSS is also included.|Measured either 3 days after ooctye pick up (Visit 9) or 18 +/- 1 days after oocyte pick up (Visit 10).|Safety population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.||Participants|||Count of Participants
852856|NCT01687712|Secondary|Adverse Events of Special Interest: Ovarian Hyperstimulation Syndrome (OHSS) - Cycle 1|Summary of the number of subjects with mild, moderate and severe OHSS. The total number of subjects with OHSS is also included.|Measured either 3 days after ooctye pick up (Visit 9) or 18 +/- 1 days after oocyte pick up (Visit 10).|Safety population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.||Participants|||Count of Participants
852857|NCT01687712|Secondary|Overall Summary of Adverse Events (AEs) - Cycle 1|"Summary of AEs, including the number of subjects experiencing to following during Cycle 1:
At least one AE At least one treatment related AE At least one serious AE At least one AE leading to discontinuation of study drug At least one AE due to pregnancy complication"|Measured from the start of r-hFSH treatment to either end of r-hFSH treament +30 days or end of pregnancy if applicable|Safety population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.||Participants|||Count of Participants
852858|NCT01687712|Secondary|Local and Systemic Adverse Events: Dermal Response to Injection by Severity - Cycle 1|Dermal response to r-hFSH injection as assessed by the investigator and categorized according to severity of reaction|Measure recorded in the Patient Diary which is maintained through entire FSH treatment|Safety population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.||Participants|||Count of Participants
852859|NCT01687712|Secondary|Local and Systemic Adverse Events: Dermal Response to Injection - Cycle 1|Number of subjects reporting at least one dermal response to r-hFSH injection and number of subjects reporting no dermal responses.|Measure recorded in the Patient Diary which is maintained through entire FSH treatment|Safety population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.||Participants|||Count of Participants
852860|NCT01687712|Secondary|Number of Oocytes Retrieved - Cycle 1|The number of oocytes retrieved per subject, following hCG administration in Cycle 1.|Visit 8, 34-36 hours after hCG administration|Intention to treat population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.||Oocytes retrieved||Standard Deviation|Mean
852861|NCT01687712|Secondary|Exposure to r-hFSH Injections: Daily Dose of r-hFSH (IU) - Cycle 1|The mean dose of r-hFSH that subjects received in a day during Cycle 1.|Measured at discretionary visits between Days 9 and 15 after FSH starts.|Intention to treat population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.||international unit (IU)||Standard Deviation|Mean
852862|NCT01687712|Secondary|Exposure to r-hFSH Injections: Total Dose of r-hFSH (IU) - Cycle 1|The total dose of r-hFSH that subjects received during Cycle 1.|Measured at discretionary visits between Days 9 and 15 after FSH starts.|Intention to treat population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.||international unit (IU)||Standard Deviation|Mean
852863|NCT01687712|Secondary|Exposure to r-hFSH Injections: Days of r-hFSH Stimulation - Cycle 1|The number of days of r-hFSH stimulation a subject received during Cycle 1.|Measured at discretionary visits between Days 9 and 15 after FSH starts|Intention to treat population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.||days||Standard Deviation|Mean
852864|NCT01687712|Primary|Clinical Pregnancy Rate After One Cycle of Treatment - PP Population|Clinical pregnancy was defined as presence of at least one intrauterine gestational sac and fetal heart activity as demonstrated by vaginal ultrasound at six weeks (42 +/- 1 day) post ET (Visit 11). The clinical pregnancy rate is the proportion of subjects who achieve clinical pregnancy, relative to the number of patients in the PP population of the respective treatment arm.|Six weeks post embryo transfer|Per-protocol population, defined as a subset of the ITT population composed of all patients without any major protocol deviation (i.e. one which would affect the primary efficacy endpoint assessment).||Participants|||Count of Participants
852905|NCT01611792|Primary|Change From Baseline to 6 Months in Oswestry Disability Scale (0-100%)|Disability; Sacle 0-100% Lower score is considered better/improved; Negative value indicates improvement|Baseline and 6 Months|Based on data reported and available||units on a scale||Standard Deviation|Mean
852865|NCT01687712|Primary|Clinical Pregnancy Rate After One Cycle of Treatment - ITT Population|Clinical pregnancy was defined as presence of at least one intrauterine gestational sac and fetal heart activity as demonstrated by vaginal ultrasound at six weeks (42 +/- 1 day) post ET (Visit 11). The clinical pregnancy rate is the proportion of subjects who achieve clinical pregnancy, relative to the number of patients in the ITT population of the respective treatment arm.|Six weeks post embryo transfer|Intention to treat population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.||Participants|||Count of Participants
852866|NCT01641042|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Month 0 until the end of the ESFU (at Month 8)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.||Participants|||Count of Participants
852867|NCT01641042|Secondary|Number of Subjects Reporting Any Unsolicited AEs|An unsolicited AE covers any untoward medical occurrence in a clinical subject investigation temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an AE reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited AE.|During the 31-day (Days 0-30) post second vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.||Participants|||Count of Participants
852868|NCT01641042|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)|An unsolicited adverse event (AE) covers any untoward medical occurrence in a clinical subject investigation temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an AE reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited AE.|During the 31-day (Days 0-30) post first vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.||Participants|||Count of Participants
852869|NCT01641042|Secondary|Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs)|NOCIs include autoimmune disorders, asthma, type 1 diabetes and allergies.|From Month 0 until the end of the Extended Safety Follow-Up [ESFU] (at Month 8)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.||Participants|||Count of Participants
852870|NCT01641042|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache and fever. Gastrointestinal symptoms include nausea, vomiting, diarrhoea and/or abdominal pain. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptoms = symptoms which prevented normal everyday activities. Grade 3 fever = oral temperature >39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 4-day (Days 0-3) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and with their symptom sheet filled in.||Participants|||Count of Participants
852871|NCT01641042|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptoms = symptoms which prevented normal everyday activities. Grade 3 fever = oral temperature >39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 4-day (Days 0-3) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and with their symptom sheet filled in.||Participants|||Count of Participants
852872|NCT01641042|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 6-17 Years|Assessed solicited local symptoms were pain, redness and swelling. Any was defined as occurrence of the symptom regardless of intensity grade. Grade 3 pain was defined as cried when limb was moved/spontaneously painful. Grade 3 redness/swelling was defined as redness/swelling spreading beyond 30 millimeters (mm) of injection site.|During the 4-day (Days 0-3) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and with their symptom sheet filled in.||Participants|||Count of Participants
852873|NCT01641042|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 1-5 Years|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.|During the 4-day (Days 0-3) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and with their symptom sheet filled in.||Participants|||Count of Participants
852874|NCT01641042|Secondary|Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens|Antibody titers were measured in geometric mean concentrations (GMCs), calculated on all subjects.|Pre-primary vaccinarion (Month 0), post first vaccine dose (Month 1) and post second vaccine dose (Month 3)|The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who complied with the blood sample schedule for Visit 2 (Month 1) and Visit 4 (Month 3), for whom data concerning immunogenicity endpoint measures were available for at least one antigen component of the vaccine.||Titers||95% Confidence Interval|Geometric Mean
852875|NCT01641042|Secondary|Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentration ≥ the Cut-off Values|The cut-off value for the assay was ≥ 2.0 μg/mL.|Pre-primary vaccinarion (Month 0), post first vaccine dose (Month 1) and post second vaccine dose (Month 3)|The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who complied with the blood sample schedule for Visit 2 (Month 1) and Visit 4 (Month 3), for whom data concerning immunogenicity endpoint measures were available for at least one antigen component of the vaccine.||Participants|||Count of Participants
852876|NCT01641042|Secondary|Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations ≥ the Cut-off Values|The cut-off value for the assay was ≥ 0.3 micrograms per milliliter (μg/m).|Pre-primary vaccinarion (Month 0), post first vaccine dose (Month 1) and post second vaccine dose (Month 3)|The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who complied with the blood sample schedule for Visit 2 (Month 1) and Visit 4 (Month 3), for whom data concerning immunogenicity endpoint measures were available for at least one antigen component of the vaccine.||Participants|||Count of Participants
852877|NCT01641042|Secondary|Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens|Antibody titers were measured in Geometric mean titers (GMTs), calculated on all subjects.|Pre-primary vaccination at Month 0, post first vaccine dose at Month 1 and post second vaccine dose at Month 3|The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who complied with the blood sample schedule for Visit 2 (Month 1) and Visit 4 (Month 3), for whom data concerning immunogenicity endpoint measures were available for at least one antigen component of the vaccine.||Titres||95% Confidence Interval|Geometric Mean
852878|NCT01641042|Secondary|Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values|The cut-off value for the assay ≥ 1:8.|Pre-primary vaccinarion (Month 0), post first vaccine dose (Month 1) and post second vaccine dose (Month 3)|The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who complied with the blood sample schedule for Visit 2 (Month 1) and Visit 4 (Month 3), for whom data concerning immunogenicity endpoint measures were available for at least one antigen component of the vaccine.||Participants|||Count of Participants
852879|NCT01641042|Secondary|Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values|The cut-off value for the assay was ≥ 1:4.|Pre-primary vaccinarion (Month 0), post first vaccine dose (Month 1) and post second vaccine dose (Month 3)|The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who complied with the blood sample schedule for Visit 2 (Month 1) and Visit 4 (Month 3), for whom data concerning immunogenicity endpoint measures were available for at least one antigen component of the vaccine.||Participants|||Count of Participants
852880|NCT01641042|Secondary|Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Meningococcal Antigens|Antibody titers were measured in geometric mean titers (GMTs), calculated on all subjects.|At pre-primary vaccination (Month 0), post first vaccine dose (Month 1) and post second vaccine dose (Month 3)|The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who complied with the blood sample schedule for Visit 2 (Month 1) and Visit 4 (Month 3), for whom data concerning immunogenicity endpoint measures were available for at least one antigen component of the vaccine.||Titers||95% Confidence Interval|Geometric Mean
852881|NCT01641042|Secondary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values|The cut-off value for the assay was ≥ 1:128.|Pre-primary vaccination at Month 0, post first vaccine dose at Month 1 and post second vaccine dose at Month 3|The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who complied with the blood sample schedule for Visit 2 (Month 1) and Visit 4 (Month 3), for whom data concerning immunogenicity endpoint measures were available for at least one antigen component of the vaccine.||Participants|||Count of Participants
852882|NCT01641042|Secondary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values|The cut-off value for the assay was ≥ 1:8.|At pre-primary vaccination (Month 0), at post first vaccine dose (Month 1) and post second vaccine dose (Month 3)|The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who complied with the blood sample schedule for Visit 2 (Month 1) and Visit 4 (Month 3), for whom data concerning immunogenicity endpoint measures were available for at least one antigen component of the vaccine.||Participants|||Count of Participants
852883|NCT01641042|Secondary|Number of Subjects With a Vaccine Response to hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies|Vaccine response was defined as: hSBA antibody titers ≥ 1:8, for initially seronegative subjects (i.e. pre-vaccination rSBA antibody titers < 1:4) and at least a 4-fold increase in hSBA antibody titers from pre to post-vaccination, for initially seropositive subjects (i.e. pre-vaccination rSBA antibody titers ≥ 1:4).|One month after the second vaccine dose (At Month 3)|The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who complied with the blood sample schedule for Visit 2 (Month 1) and Visit 4 (Month 3), for whom data concerning immunogenicity endpoint measures were available for at least one antigen component of the vaccine.||Participants|||Count of Participants
852884|NCT01641042|Secondary|Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies|Vaccine response was defined as: rSBA antibody titers ≥ 1:32, for initially seronegative subjects (i.e. pre-vaccination rSBA antibody titers < 1:8) and at least a 4-fold increase in rSBA antibody titers from pre to post-vaccination, for initially seropositive subjects (i.e. pre-vaccination rSBA antibody titers ≥ 1:8).|One month after the second vaccine dose (At Month 3)|The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who complied with the blood sample schedule for Visit 2 (Month 1) and Visit 4 (Month 3), for whom data concerning immunogenicity endpoint measures were available for at least one antigen component of the vaccine.||Participants|||Count of Participants
852885|NCT01641042|Primary|Number of Subjects With a Vaccine Response for Serum Bactericidal Assay Using Human Complement Against N. Meningitides Serogroups A, C, W-135 and Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135, hSBA-MenY) Antibodies|Vaccine response was defined as: hSBA antibody titers ≥ 1:8, for initially seronegative subjects (i.e. pre-vaccination rSBA antibody titers < 1:4) and at least a 4-fold increase in hSBA antibody titers from pre to post-vaccination, for initially seropositive subjects (i.e. pre-vaccination rSBA antibody titers ≥ 1:4).|One month after the first vaccine dose (at Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who complied with the blood sample schedule for Visit 2 (Month 1) and Visit 4 (Month 3), for whom data concerning immunogenicity endpoint measures were available for at least one antigen component of the vaccine.||Participants|||Count of Participants
852906|NCT01611792|Primary|Change From Baseline to 11 Weeks in Oswestry Disability Scale (0-100%)|Disability; Scale 0-100% Lower score is considered better/improved Negative value indicates improvement|Baseline and 11 weeks|Based on data reported and available||units on a scale||Standard Deviation|Mean
852886|NCT01641042|Primary|Number of Subjects With a Vaccine Response for Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY) Antibodies|Vaccine response was defined as: rSBA antibody titers greater than or equal to (≥) 1:32, for initially seronegative subjects [i.e. pre-vaccination rSBA antibody titers below (<) 1:8] and at least a 4-fold increase in rSBA antibody titers from pre to post-vaccination, for initially seropositive subjects (i.e. pre-vaccination rSBA antibody titers ≥ 1:8).|One month after the first vaccine dose (at Month 1)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all eligible subjects who complied with the blood sample schedule for Visit 2 (Month 1) and Visit 4 (Month 3), for whom data concerning immunogenicity endpoint measures were available for at least one antigen component of the vaccine.||Participants|||Count of Participants
852887|NCT01626352|Secondary|Progression-free Survival|Defined as the time from first treatment until objective tumor progression, relapse from complete response, or death from any cause|after cycles 3 and 6 of each 21-day cycle, and every 3 months thereafter until progression|All enrolled patients who have received study treatment.||months||90% Confidence Interval|Median
852888|NCT01626352|Secondary|Number of Patients With Treatment-Related Adverse Events (AEs) as a Measure of Safety|A treatment-related adverse event was any untoward medical occurrence in a participant which was considered to have a relationship with the study drug (suspected to be possibly or probably related to the study drug per the Investigator’s assessment). Adverse events were evaluated using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0.|after cycles 3 and 6 of each 21-day cycle, and up to 30 days after last dose, projected 24 weeks|All enrolled patients who received the study treatment.||Participants|||Count of Participants
852889|NCT01626352|Secondary|Overall Response (OR)|Overall response is the number of patients with observed complete or partial response (CR or PR) as assessed using the International Working Group (IMW) revised response criteria for malignant lymphoma. Complete response requires disappearance of all evidence of disease. Partial response requires regression of measurable disease and no new sites.|after cycles 3 and 6 of each 21-day cycle, and every 3 months thereafter, projected 18 months|All patients treated with study drugs and having a post baseline response assessment.||Participants|||Count of Participants
852890|NCT01626352|Secondary|Overall Survival (OS)|Defined as the time from Day 1 of study drug administration to date of death from any cause.|every 3 cycles during treatment and every 3 months thereafter until progression or death from any cause, projected 18 months|All enrolled patients who have received study treatment.||months||90% Confidence Interval|Median
852891|NCT01626352|Secondary|Time to Progression (TTP)|Defined as the time from date of first treatment to the date of first documented disease progression or relapse from complete response.|after cycles 3 and 6 of each 21-day cycle, and every 3 months thereafter until progression|All enrolled patients who have received study treatment.||months||95% Confidence Interval|Median
852892|NCT01626352|Secondary|Duration of Response|Defined as the time from date of first documented confirmed response to date of disease progression or relapse from complete response. Patients who are alive and free from disease progression will be censored at the date of last tumor assessment. Patients who begin further anticancer therapy prior to disease progression will be censored at the date of last tumor assessment prior to the start date of the anticancer therapy.|after cycles 3 and 6 of each 21-day cycle and every 3 months thereafter|All patients treated with study drugs and having a post baseline response assessment.||months||90% Confidence Interval|Median
852893|NCT01626352|Primary|Number of Patients With a Complete Response|Disease response assessments will be performed using the International Working Group (IMW)-revised response criteria for malignant lymphoma. Complete response requires a disappearance of all evidence of disease.|18 months|All patients treated with study drugs and having a post baseline response assessment.||Participants|||Count of Participants
852901|NCT01611792|Primary|Change From 11 Weeks to 6 Months in Numeric Pain Rating Scale (0-10 Points)|Current Pain Scale 0-10 Lower score is better/improved; Negative value indicates improvement|11 weeks and 6 months|Based on data reported and available||units on a scale||Standard Deviation|Mean
852902|NCT01611792|Primary|Change From Baseline to 6 Months in Numeric Pain Rating Scale (0-10 Points)|Current Pain Scale 0-10 Lower score is better/improved; Negative value indicates improvement|Baseline and 6 months|Based on data reported and available||units on a scale||Standard Deviation|Mean
852903|NCT01611792|Primary|Change From Baseline to 11 Weeks in Numeric Pain Rating Scale (0-10 Points)|Current Pain Scale 0-10 Lower score is better/improved; Negative value indicates improvement|Baseline and 11 weeks|Based on data reported and available||units on a scale||Standard Deviation|Mean
852904|NCT01611792|Primary|Change From 11 Weeks to 6 Months in Oswestry Disability Scale (0-100%)|Disability; Sacle 0-100% Lower score is considered better/improved; Negative value indicates improvement|11 Weeks and 6 Months|Based on data reported and available||units on a scale||Standard Deviation|Mean
852919|NCT01594385|Secondary|Wound Healing Characteristics|There will not be a fixed duration of outpatient follow-up (fixed follow-up in trauma patients is not practical due to the unpredictable nature of trauma population), an average (mean) follow-up will be determined for the entire cohort of patients for the purposes of the study, up to a maximum of 1 year (if available) following hospital discharge.|Participants will be followed until their open abdomen is closed. Depending on the nature and severity of the wound, this period may last as long as 1 year after the patient has been discharged.|"Wound areas for Seprafilm and No Seprafilm groups were obtained serially, by measuring each wound horizontally and vertically and multiplying measurements (in centimeters) to determine the estimated area in cm squared."||Square Centimeters (cm2)||Standard Deviation|Mean
852920|NCT01594385|Primary|Adhesion Characteristics|"Zuhlke adhesion score (1 - minimum to 4 - maximum)
= filmy adhesions, easy to separate by blunt dissection
= stronger adhesions; blunt dissection possible, partly sharp dissection necessary; beginning of vascularization
= strong adhesions; lysis possible by sharp dissection only; clear vascularization
= very strong adhesions; lysis possible by sharp dissection only; organs strongly attached with severe adhesions; damage to organs hardly preventable"|Up to 1 year|||Scores on a scale|Zuhlke Adhesion Score|Standard Error|Mean
853022|NCT01369641|Primary|Efficacy of Intratympanic Sodium Thiosulfate (STS)|"To assess the efficacy of intratympanic sodium thiosulfate (STS) on reducing the degree or incidence of hearing loss in patients receiving systemic cisplatin therapy using puretone and speech audiometry, and distortion product otoacoustic emissions (DPOAE).
Pure tone and speech audiometry: hearing will be assessed prior to any initiation of cisplatin therapy, again at three weeks, 6 weeks, 12 weeks, and every 6 months thereafter for up to one year."|Through 1 year post-treatment||||||
853023|NCT01364090|Secondary|Behavioral and Quality of Life|Evaluate changes in illicit drug use, opiate substitution therapy, depression, suicidal ideations and health-related quality of life in participants treated with PEG-IFN alfa-2b in combination with self-administered ribavirin for 12 weeks in participants with non-quantifiable HCV RNA or undetectable HCV RNA on qualitative assay at week 4 of therapy and for 24 weeks in participants with quantifiable HCV RNA or detectable HCV RNA at week 4 of therapy.|48 weeks||||||
853024|NCT01364090|Secondary|Treatment Response (ETR & SVR24)|Evaluate the percentage with undetectable HCV RNA at end of treatment (ETR) and 24 weeks post end of treatment (SVR24) in participants treated with PEG-IFN alfa-2b in combination with self-administered ribavirin for 12 weeks in participants with non quantifiable HCV RNA or undetectable HCV RNA at week 4 of therapy and for 24 weeks in participants with quantifiable HCV RNA or detectable HCV RNA at week 4 of therapy.|48 weeks||||||
853025|NCT01364090|Secondary|Treatment Adherence|Evaluate the adherence (>80 of PEG-IFN, >80% of RBV, >80% of time) to directly observed PEG-IFN alfa-2b in combination with self-administered ribavirin for 12 weeks in participants with non-quantifiable HCV RNA or undetectable HCV RNA on qualitative assay at week 4 of therapy and for 24 weeks in participants with quantifiable HCV RNA or detectable HCV RNA on qualitative assay at week 4 of therapy.|48 weeks||||||
853026|NCT01364090|Secondary|Safety and Tolerability|Evaluate the safety and tolerability of directly observed PEG-IFN alfa-2b in combination with self-administered ribavirin for 12 weeks in participants with non-quantifiable HCV RNA or undetectable HCV RNA on qualitative assay at week 4 of therapy and for 24 weeks in participants with quantifiable HCV RNA or detectable HCV RNA on qualitative assay at week 4 of therapy.|48 weeks||||||
853027|NCT01364090|Primary|Treatment Efficacy|The primary outcome measure is the proportion of patients with undetectable HCV RNA at 12 weeks post end of treatment (SVR12) following directly observed PEG-IFN alfa-2b in combination with self-administered ribavirin for 12 weeks in participants with non-quantifiable (<15 IU/ml detected and <15 IU/ml undetected) HCV RNA or undetectable HCV RNA on qualitative assay at week 4 of therapy and for 24 weeks in participants with quantifiable (≥15 IU/ml) HCV RNA or detectable HCV RNA on qualitative assay at week 4 of therapy.|36 weeks|||participants|||Number
853037|NCT01323387|Secondary|Oswestry Disability Index (ODI) Summary|The Oswestry Disability Index (ODI) is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain. The scores can range from 0 to 100 with 0 equating to No Disability and 100 equating to the Maximum Disability Possible|Baseline and 24 Months|||Units on a scale||Standard Deviation|Mean
853038|NCT01323387|Secondary|SF-12 Mental Composite Score (MCS) Summary|The MCS (Mental Component Score) is a measurement of health status with a range of 0 to 100. A higher score indicates less disability.|Baseline and 24 Months|||Units on a scale||Standard Deviation|Mean
853039|NCT01323387|Secondary|SF-12 Physical Composite Score (PCS) Summary|The PCS (Physical Component Score) is a measurement of health status with a range of 0 to 100. A higher score indicates less disability.|Baseline and 24 Months|||Units on a scale||Standard Deviation|Mean
853040|NCT01323387|Secondary|Quality of Life Using SF-12 Scale (MCS): Number of Subjects Who Achieved 15% Improvement in MCS Compared to Baseline|The outcome measure is the number of subjects who achieved a 15% improvement in MCS compared to baseline. The MCS (Mental Component Score) is a measurement of health status with a range of 0 to 100. A higher score indicates less disability.|Baseline and 24 Months|||Count of subjects|||Number
853041|NCT01323387|Secondary|Oswestry Disability Index (ODI): Number of Subjects Who Achieved a 15% Improvement in ODI Compared to Baseline|The outcome measure is the number of subjects who achieved a 15% improvement in ODI compared to baseline. The ODI is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain. ODI scores range from 0 to 100 with 0 equating to No Disability and 100 equating to the Maximum Disability Possible|24 Months|||Count of subjects|||Number
853042|NCT01323387|Secondary|Pain Scores on the Numeric Rating Scale (NRS)|The Numeric Rating Scale (NRS) is a measurement of pain from a value of 0 (no pain) to a value of 10 (worst pain)|Baseline and 24 Months|||units on a scale||Standard Deviation|Mean
853043|NCT01323387|Secondary|Quality of Life Using the SF-12 Scale Physical Health Component Score (PCS). Number of Subjects Who Achieved 15% Improvement in PCS Compared to Baseline.|Quality of Life using the SF-12 Scale Physical Health Component Score (PCS). The PCS is a measurement of health status with a range of 0-100. A higher score indicates less disability.|24 Months|||Count of subjects|||Number
853044|NCT01323387|Primary|Number of Subjects With Successful Radiographic Fusion|CT Scans and plain film x-rays will be evaluated. Demonstration of bridging trabecular bone through or external to the allograft spacer will be the measure of success.|24 Months|||Count of subjects|||Number
853045|NCT01295112|Secondary|The Secondary Efficacy Endpoint is the Visual Acuity Score Based on Best Corrected Visual Acuity (BCVA) at Week 24|Change in BCVA at Week 24 from baseline|24 weeks|||letters||Standard Deviation|Mean
853046|NCT01295112|Primary|The Primary Efficacy Endpoint is the Total Number of PRN Bevacizumab Intravitreal Injections Through 24 Weeks||24 weeks|||Participants|||Count of Participants
853246|NCT01196416|Secondary|Change in Protein Levels by Immunohistochemistry (Phase Ib)|"Pre and post-treatment protein levels will be compared by Wilcoxon signed-rank test (for paired samples).
Data is not yet available, as it's currently being analyzed."|Baseline up to 2 weeks||||||
853127|NCT01256671|Primary|Long-term Safety of Intravaginal Prasterone (DHEA): Endometrium|The long-term safety of intravaginal prasterone has been evaluated on different parameters including the endometrium. For this purpose, endometrial biopsies were performed at screening and at the end of the study (52 weeks) or at discontinuation visit for women who were exposed to intravaginal DHEA (prasterone) for at least 12 weeks. At screening, the endometrium had to be atrophic/inactive for women to be enrolled in the study. Only the end-of-study data are presented.|Baseline and Week 52 (or discontinuation)|Only subjects in the Safety Population who had an end-of-study endometrial biopsy are included in the analysis.||Participants|||Count of Participants
853120|NCT01256671|Primary|Long-term Safety of Intravaginal Prasterone (DHEA): Serum Steroid Levels|The long-term safety of intravaginal prasterone has been evaluated on different parameters including the serum levels of DHEA and its metabolites. For this purpose, blood samples were collected at Baseline and different post-Baseline timepoints for the determination of serum steroid levels by a central laboratory using validated liquid chromatography tandem mass spectrometry (LC-MS/MS) methods. The serum levels of dehydroepiandrosterone (DHEA), estradiol (E2) and testosterone (TESTO) obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented.|Baseline and Week 52|Data are presented for subjects in the Safety Population who have steroid data at both baseline and Week 52.||pg/mL||Standard Error|Mean
853121|NCT01256671|Secondary|Change From Baseline to Week 52 of Self-assessment of VVA Symptom Irritation/Itching|The severity of irritation/itching was evaluated by a questionnaire. The severity of irritation/itching recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented.|Baseline and Week 52|"Overall, 476 subjects met vulvovaginal atrophy (VVA) criteria by having moderate/severe (MS) dyspareunia, dryness and/or irritation/itching. The analysis MS only includes subjects having MS irritation/itching (being or not most bothersome (MBS)) (n=86); the analysis MBS/MS only includes subjects with MS irritation/itching being MBS (n=23)."||units on a scale||Standard Error|Mean
853122|NCT01256671|Secondary|Change From Baseline to Week 52 of Self-assessment of VVA Symptom Vaginal Dryness|The severity of vaginal dryness was evaluated by a questionnaire. The severity of vaginal dryness recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented.|Baseline and Week 52|"Overall, 476 subjects met vulvovaginal atrophy (VVA) criteria by having moderate/severe (MS) dyspareunia, dryness and/or irritation/itching. The analysis MS only includes subjects having MS dryness (being or not most bothersome (MBS)) (n=251); the analysis MBS/MS only includes subjects with MS dryness being MBS (n=81)."||units on a scale||Standard Error|Mean
853123|NCT01256671|Secondary|Change From Baseline to Week 52 of Self-assessment of VVA Symptom Dyspareunia|The severity of dyspareunia was evaluated by a questionnaire. The severity of dyspareunia recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented.|Baseline and Week 52|"Overall, 476 subjects met vulvovaginal atrophy (VVA) criteria by having moderate/severe (MS) dyspareunia, dryness and/or irritation/itching. The analysis MS dyspareunia only includes subjects having MS dyspareunia (being or not most bothersome (MBS)) (n=240); the analysis MBS/MS only includes subjects with MS dyspareunia being MBS (n=183)."||units on a scale||Standard Error|Mean
853124|NCT01256671|Secondary|Change From Baseline to Week 52 of Vaginal pH.|A pH strip fixed on an Ayre spatula (or equivalent) was applied directly to the lateral wall of the vagina. The change in color of the pH indicator strip was compared to the color chart for pH evaluation. The corresponding pH value (with one decimal) was recorded. Data obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented.|Baseline and Week 52|"Subgroups of the Safety Population were used for analysis. The subgroup identified ALL includes subjects meeting or not the vulvovaginal atrophy (VVA) criteria at Baseline while the subgroup VVA only includes subjects meeting VVA criteria (pH ˃5, superficial cells ≤ 5% and moderate/severe VVA symptom being most bothersome (MBS))."||pH||Standard Error|Mean
853125|NCT01256671|Secondary|Change From Baseline to Week 52 of Vaginal Cell Maturation (Percentage of Superficial Cells).|The percentage of superficial cells was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented.|Baseline and Week 52|"Subgroups of the Safety Population were used for analysis. The subgroup identified ALL includes subjects meeting or not the vulvovaginal atrophy (VVA) criteria at Baseline while the subgroup VVA only includes subjects meeting VVA criteria (pH ˃5, superficial cells ≤ 5% and moderate/severe VVA symptom being most bothersome (MBS))."||percentage of superficial cells||Standard Error|Mean
853126|NCT01256671|Secondary|Change From Baseline to Week 52 of Vaginal Cell Maturation (Percentage of Parabasal Cells).|The percentage of parabasal cells was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented.|Baseline and Week 52|"Subgroups of the Safety Population were used for analysis. The subgroup identified ALL includes subjects meeting or not the vulvovaginal atrophy (VVA) criteria at Baseline while the subgroup VVA only includes subjects meeting VVA criteria (pH ˃5, superficial cells ≤ 5% and moderate/severe VVA symptom being most bothersome (MBS))."||percentage of parabasal cells||Standard Error|Mean
853128|NCT01239394|Secondary|Toxicity: Infusion Reactions, Grade 3-4 Infections, and Neutropenia|Evaluate safety of ofatumumab monotherapy in this patient population Toxicities are graded 1 (mild), 2 (moderate), 3 (severe), and 4 (life-threatening)|2 years|||Participants|||Count of Participants
853129|NCT01239394|Secondary|Progression-free Survival (PFS)|Percentage of patients with progression-free survival during 12 months post-treatment progression-free survival: patients live with the disease, but it does not get worse|12 months|||percentage of patients||95% Confidence Interval|Number
853130|NCT01239394|Secondary|Overall Response Rate (ORR)|"Evaluate clinical efficacy of ofatumumab in previously untreated indolent B-cell lymphomas, as measured by overall response rate (ORR).
Overall response = Complete response (CR) + Partial response (PR) CR = all previously enlarged fluorodeoxyglucose (FDG)-avid or positron emission tomography (PET)-positive lymph nodes regressed to normal size (<=1.5cm in greatest diameter) PR = >=50% decrease in SPD of up to six largest dominant masses, no increase in size of other nodes; FDG avid or PET positive before therapy, one or more nodes PET positive at previously involved site, or variably FDG avid or PET negative with regression at CT"|1-month post-treatment|||percentage of patients|||Number
853131|NCT01239394|Primary|Efficacy: Complete Response Rate (CRR)|"Evaluate clinical efficacy of ofatumumab in previously untreated indolent B-cell lymphomas, as measured by complete response rate (CRR).
Complete response = all previously enlarged fluorodeoxyglucose (FDG)-avid or positron emission tomography (PET)-positive lymph nodes regressed to normal size (<=1.5 cm in greatest diameter)"|1-month post-treatment|||percentage of patients|||Number
853247|NCT01196416|Primary|Maximum Tolerated Dose for RO4929097|based on the incidence of dose-limiting toxicity as assessed the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase IB)|21 days|||mg/day|||Number
853187|NCT01212770|Secondary|Number of Participants With Adverse Events||Up to 5 years||12/2017||||
853188|NCT01212770|Secondary|Percentage of Participants Achieving a Dactylitis Score of Zero at Week 52|"Percentage of participants with pre-existing dactylitis whose dactylitis severity score improves to zero after 52 weeks.
Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.
Two-sided 95% confidence interval is based on the Clopper-Pearson method."|Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; Participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) and who had sufficient data for a definitive determination of response status at Week 52 are included.||percentage of participants||95% Confidence Interval|Number
853189|NCT01212770|Secondary|Percentage of Participants Achieving a MASES Score of Zero at Week 52|"Percentage of participants with pre-existing enthesopathy whose MASES improves to 0 after 24 weeks. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):
1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right.
The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.
Two-sided 95% confidence interval is based on the Clopper-Pearson method."|Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants with a baseline value > 0 (i.e., pre-existing enthesopathy) and who had sufficient data for a definitive determination of response status at Week 52 are included.||percentage of participants||95% Confidence Interval|Number
853190|NCT01212770|Secondary|Percentage of Participants With an ACR 70 Response at Week 52|"Percentage of participants with an American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:
≥ 70% improvement in 78 tender joint count;
≥ 70% improvement in 76 swollen joint count; and
≥ 70% improvement in at least 3 of the 5 following parameters:
Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
Patient's global assessment of disease activity (measured on a 100 mm VAS);
Physician's global assessment of disease activity (measured on a 100 mm VAS);
Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));
C-Reactive Protein.
Two-sided 95% confidence interval is based on the Clopper-Pearson method."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.||percentage of participants||95% Confidence Interval|Number
853191|NCT01212770|Secondary|Percentage of Participants With an ACR 50 Response at Week 52|"Percentage of participants with an American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:
≥ 50% improvement in 78 tender joint count;
≥ 50% improvement in 76 swollen joint count; and
≥ 50% improvement in at least 3 of the 5 following parameters:
Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
Patient's global assessment of disease activity (measured on a 100 mm VAS);
Physician's global assessment of disease activity (measured on a 100 mm VAS);
Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));
C-Reactive Protein.
Two-sided 95% confidence interval is based on the Clopper-Pearson method."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.||percentage of participants||95% Confidence Interval|Number
853248|NCT01196416|Primary|Overall Survival (Phase II)|Overall response rate (complete [CR] or partial response [PR]) according to RECIST version 1.1|Up to 2 years|||participants|||Number
853192|NCT01212770|Secondary|Percentage of Participants Achieving Good or Moderate EULAR Response at Week 52|"A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score.
A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 3.2.
A Moderate Response is defined as either:
an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 score of less than or equal to 5.1 or,
an improvement (decrease) in the DAS28 of more than 1.2 and attainment of a DAS28 score of greater than 3.2.
Two-sided 95% confidence interval is based on the Clopper-Pearson method."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.||percentage of participants|||Number
853193|NCT01212770|Secondary|Percentage of Participants With Dactylitis Improvement ≥ 1 Point at Week 52|"Percentage of participants with pre-existing dactylitis whose dactylitis severity score improved by ≥ 1 after 52 weeks.
Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.
Two-sided 95% confidence interval is based on the Clopper-Pearson method."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; Participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) and who had sufficient data for a definitive determination of response status at Week 52 are included.||percentage of participants||95% Confidence Interval|Number
853194|NCT01212770|Secondary|Percentage of Participants With MASES Improvement ≥ 20% at Week 52|"Percentage of participants with pre-existing enthesopathy whose MASES improved by ≥ 20% from Baseline after 52 weeks. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):
1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right.
The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.
Two-sided 95% confidence interval is based on the Clopper-Pearson method."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) and who had sufficient data for a definitive determination of response status at Week 52 are included.||percentage of participants||95% Confidence Interval|Number
853195|NCT01212770|Secondary|Change From Baseline in the FACIT-Fatigue Scale Score at Week 52|"The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue. A positive change from baseline score indicates an improvement."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.||units on a scale||Standard Deviation|Mean
853196|NCT01212770|Secondary|Change From Baseline in the DAS28 at Week 52|"The DAS28 measures the severity of disease at a specific time and is derived from the following variables:
28 tender joint count
28 swollen joint count, which do not include the DIP joints, the hip joint, or the joints below the knee;
C-reactive protein (CRP)
Patient's global assessment of disease activity.
DAS28(CRP) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.||units on a scale||Standard Deviation|Mean
853197|NCT01212770|Secondary|Change From Baseline in the CDAI Score at Week 52|"The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:
28 tender joint count (TJC),
28 swollen joint count (SJC),
Patient's Global Assessment of Disease Activity measured on a 10 cm visual analog scale (VAS), where 0 cm = lowest disease activity and 10 cm = highest;
Physician's Global Assessment of Disease Activity -measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest.
The CDAI score ranges from 0-76 where lower scores indicate less disease activity.
The following thresholds of disease activity have been defined for the CDAI: Remission: ≤ 2.8 Low Disease Activity: > 2.8 and ≤ 10 Moderate Disease Activity: > 10 and ≤ 22 High Disease Activity: > 22."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.||units on a scale||Standard Deviation|Mean
853198|NCT01212770|Secondary|Change From Baseline in the Dactylitis Severity Score at Week 52|Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet will be rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a baseline value > 0 (i.e., pre-existing dactylitis) and a Week 52 value are included.||units on a scale||Standard Deviation|Mean
853199|NCT01212770|Secondary|Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 52|"The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):
1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right.
The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a baseline value > 0 (i.e., pre-existing enthesopathy) and a Week 52 value are included.||units on a scale||Standard Deviation|Mean
853200|NCT01212770|Secondary|Change From Baseline in the Patient Assessment of Pain at Week 52|"The participant was asked to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents no pain, and the right-hand boundary (score = 100 mm) represents pain as severe as can be imagined. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.||mm||Standard Deviation|Mean
853201|NCT01212770|Secondary|Percentage of Participants Achieving a ≥ 75% Improvement in Psoriasis Area and Severity Index Score (PASI75) at Week 52|"The percentage of participants with Baseline psoriasis body surface area (BSA) involvement ≥ 3% who achieved 75% or greater improvement from Baseline in Psoriasis Area and Severity Index (PASI) score after 52 weeks.
The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by erythema (reddening), induration (plaque thickness) and desquamation (scaling) scored on a scale from 0 (none) to 4 (very severe), together with the percentage of the area affected, rated on a scale from 0 (no involvement) to 6 (90% to 100% involvement). PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.
Two-sided 95% confidence interval is based on the Clopper-Pearson method."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with Baseline Psoriasis Body Surface Area ≥ 3% and a Week 52 value are included.||percentage of participants||95% Confidence Interval|Number
853202|NCT01212770|Secondary|Percentage of Participants With a Modified PsARC Response at Week 52|"Modified PsARC response is defined as improvement in at least 2 of the 4 measures, at least one of which must be tender joint count or swollen joint count, and no worsening in any of the 4 measures:
78 tender joint count,
76 swollen joint count,
Patient global assessment of disease activity, measured on a 100 mm visual Analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest;
Physician global assessment of disease activity, measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest.
Improvement or worsening in joint counts is defined as decrease or increase, respectively, from baseline by ≥ 30%, and improvement or worsening in global assessments is defined as decrease or increase, respectively, from baseline by ≥ 20 mm VAS.
Two-sided 95% confidence interval is based on the Clopper-Pearson method."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.||percentage of participants||95% Confidence Interval|Number
853203|NCT01212770|Secondary|Change From Baseline in the SF-36 Physical Functioning Scale Score at Week 52|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.||units on a scale||Standard Deviation|Mean
853204|NCT01212770|Secondary|Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 52|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.||units on a scale||Standard Deviation|Mean
853205|NCT01212770|Secondary|Percentage of Participants With an ACR 20 Response at Week 52|"Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:
≥ 20% improvement in 78 tender joint count;
≥ 20% improvement in 76 swollen joint count; and
≥ 20% improvement in at least 3 of the 5 following parameters:
Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
Patient's global assessment of disease activity (measured on a 100 mm VAS);
Physician's global assessment of disease activity (measured on a 100 mm VAS);
Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));
C-Reactive Protein.
Two-sided 95% confidence interval is based on the Clopper-Pearson method."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population consists of all participants who were randomized or re-randomized to apremilast at any time during the study. Only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.||percentage of participants||95% Confidence Interval|Number
853206|NCT01212770|Secondary|Percentage of Participants Achieving a Dactylitis Score of Zero at Week 24|"Percentage of participants with pre-existing dactylitis whose dactylitis severity score improves to zero after 24 weeks of treatment.
Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present."|Week 24|Full analysis set; participants with a baseline dactylitis severity score > 0 are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
853249|NCT01196416|Primary|Maximum-tolerated Dose for Cisplatin, Vinblastine and TMZ|"based on the incidence of dose-limiting toxicity as assessed the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase IB)
Data is not yet available, as it's currently being analyzed."|21 days|||mg/m2|||Number
853207|NCT01212770|Secondary|Percentage of Participants Achieving a MASES Score of Zero at Week 24|"Percentage of participants with pre-existing enthesopathy whose MASES improves to 0 after 24 weeks of treatment. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):
1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right.
The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses."|Week 24|Full analysis set; participants with a baseline MASES > 0 are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
853208|NCT01212770|Secondary|Percentage of Participants Achieving a Dactylitis Score of Zero at Week 16|"Percentage of participants with pre-existing dactylitis whose dactylitis severity score improves to zero after 16 weeks of treatment.
Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present."|Week 16|Full analysis set; participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
853209|NCT01212770|Secondary|Percentage of Participants Achieving a MASES Score of Zero at Week 16|"Percentage of participants with pre-existing enthesopathy whose MASES improves to 0 after 16 weeks of treatment. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):
1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right.
The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses."|Week 16|Full analysis set; participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
853210|NCT01212770|Secondary|Percentage of Participants With a ACR 70 Response at Week 24|"Percentage of participants with an American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:
≥ 70% improvement in 78 tender joint count;
≥ 70% improvement in 76 swollen joint count; and
≥ 70% improvement in at least 3 of the 5 following parameters:
Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
Patient's global assessment of disease activity (measured on a 100 mm VAS);
Physician's global assessment of disease activity (measured on a 100 mm VAS);
Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));
C-Reactive Protein."|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
853211|NCT01212770|Secondary|Percentage of Participants With an ACR 50 Response at Week 24|"Percentage of participants with an American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:
≥ 50% improvement in 78 tender joint count;
≥ 50% improvement in 76 swollen joint count; and
≥ 50% improvement in at least 3 of the 5 following parameters:
Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
Patient's global assessment of disease activity (measured on a 100 mm VAS);
Physician's global assessment of disease activity (measured on a 100 mm VAS);
Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));
C-Reactive Protein."|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
853212|NCT01212770|Secondary|Percentage of Participants With an ACR 70 Response at Week 16|"Percentage of participants with an American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:
≥ 70% improvement in 78 tender joint count;
≥ 70% improvement in 76 swollen joint count; and
≥ 70% improvement in at least 3 of the 5 following parameters:
Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
Patient's global assessment of disease activity (measured on a 100 mm VAS);
Physician's global assessment of disease activity (measured on a 100 mm VAS);
Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));
C-Reactive Protein."|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
853213|NCT01212770|Secondary|Percentage of Participants With a ACR 50 Response at Week 16|"Percentage of participants with an American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:
≥ 50% improvement in 78 tender joint count;
≥ 50% improvement in 76 swollen joint count; and
≥ 50% improvement in at least 3 of the 5 following parameters:
Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
Patient's global assessment of disease activity (measured on a 100 mm VAS);
Physician's global assessment of disease activity (measured on a 100 mm VAS);
Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));
C-Reactive Protein."|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
853214|NCT01212770|Secondary|Percentage of Participants With Good or Moderate EULAR Response at Week 24|"EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score.
A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 3.2.
A Moderate Response is defined as either:
an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 score of less than or equal to 5.1 or,
an improvement (decrease) in the DAS28 of more than 1.2 and attainment of a DAS28 score of greater than 3.2."|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
853215|NCT01212770|Secondary|Percentage of Participants With Dactylitis Improvement ≥ 1 Point at Week 24|"Percentage of participants with pre-existing dactylitis whose dactylitis severity score improved by ≥ 1 after 24 weeks of treatment.
Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present."|Baseline and Week 24|Full analysis set; participants with a baseline dactylitis severity score > 0 are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
853216|NCT01212770|Secondary|Percentage of Participants With MASES Improvement ≥ 20% at Week 24|"Percentage of participants with pre-existing enthesopathy whose MASES improved by ≥ 20% from Baseline after 24 weeks of treatment. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):
1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right.
The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses."|Baseline and Week 24|Full analysis set; participants with a baseline MASES > 0 are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
853217|NCT01212770|Secondary|Percentage of Participants With Good or Moderate European League Against Rheumatism (EULAR) Response at Week 16|"A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score.
A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 3.2.
A Moderate Response is defined as either:
an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 score of less than or equal to 5.1 or,
an improvement (decrease) in the DAS28 of more than 1.2 and attainment of a DAS28 score of greater than 3.2."|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
853218|NCT01212770|Secondary|Percentage of Participants With Dactylitis Improvement ≥ 1 Point at Week 16|"Percentage of participants with pre-existing dactylitis whose dactylitis severity score improved by ≥ 1 after 16 weeks of treatment.
Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present."|Baseline and Week 16|Full analysis set; participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
853219|NCT01212770|Secondary|Percentage of Participants With MASES Improvement ≥ 20% at Week 16|"Percentage of participants with pre-existing enthesopathy whose MASES improved by ≥ 20% from Baseline after 16 weeks of treatment. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):
1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right.
The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses."|Baseline and Week 16|Full analysis set; participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
853220|NCT01212770|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 24|"The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue. A positive change from baseline score indicates an improvement."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||units on a scale||Standard Error|Least Squares Mean
853221|NCT01212770|Secondary|Change From Baseline in the Disease Activity Score (DAS28) at Week 24|"The DAS28 measures the severity of disease at a specific time and is derived from the following variables:
28 tender joint count
28 swollen joint count, which do not include the DIP joints, the hip joint, or the joints below the knee;
C-reactive protein (CRP)
Patient's global assessment of disease activity.
DAS28(CRP) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||units on a scale||Standard Error|Least Squares Mean
853222|NCT01212770|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 24|"The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:
28 tender joint count (TJC),
28 swollen joint count (SJC),
Patient's Global Assessment of Disease Activity measured on a 10 cm visual analog scale (VAS), where 0 cm = lowest disease activity and 10 cm = highest;
Physician's Global Assessment of Disease Activity -measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest.
The CDAI score ranges from 0-76 where lower scores indicate less disease activity.
The following thresholds of disease activity have been defined for the CDAI: Remission: ≤ 2.8; Low Disease Activity: > 2.8 and ≤ 10; Moderate Disease Activity: > 10 and ≤ 22; High Disease Activity: > 22."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||units on a scale||Standard Error|Least Squares Mean
853223|NCT01212770|Secondary|Change From Baseline in Dactylitis Severity Score at Week 24|Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet will be rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Baseline and Week 24|Full analysis set. Participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) and at least 1 postbaseline value at or prior to Week 24 are included. LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||units on a scale||Standard Error|Least Squares Mean
853224|NCT01212770|Secondary|Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 24|"The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):
1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right.
The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses."|Baseline and week 24|Full analysis set; participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||units on a scale||Standard Error|Least Squares Mean
853225|NCT01212770|Secondary|Change From Baseline in Patient’s Assessment of Pain at Week 24|"The participant was asked to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents no pain, and the right-hand boundary (score = 100 mm) represents pain as severe as can be imagined. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||mm||Standard Error|Least Squares Mean
853226|NCT01212770|Secondary|Percentage of Participants Achieving a ≥ 75% Improvement in Psoriasis Area and Severity Index Score (PASI75) at Week 24|"The percentage of participants with Baseline psoriasis body surface area (BSA) involvement ≥ 3% who achieved 75% or greater improvement from Baseline in Psoriasis Area and Severity Index (PASI) score after 24 weeks of treatment.
The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by erythema (reddening), induration (plaque thickness) and desquamation (scaling) scored on a scale from 0 (none) to 4 (very severe), together with the percentage of the area affected, rated on a scale from 0 (no involvement) to 6 (90% to 100% involvement). PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease."|Baseline and Week 24|Full analysis set; participants with baseline psoriasis involvement ≥ 3% of BSA are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
853227|NCT01212770|Secondary|Percentage of Participants With a Modified Psoriatic Arthritis Response Criteria (PsARC) Response at Week 24|"Modified PsARC response is defined as improvement in at least 2 of the 4 measures, at least one of which must be tender joint count or swollen joint count, and no worsening in any of the 4 measures:
78 tender joint count,
76 swollen joint count,
Patient global assessment of disease activity, measured on a 100 mm visual Analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest;
Physician global assessment of disease activity, measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest.
Improvement or worsening in joint counts is defined as decrease or increase, respectively, from baseline by ≥ 30%, and improvement or worsening in global assessments is defined as decrease or increase, respectively, from baseline by ≥ 20 mm VAS."|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
853228|NCT01212770|Secondary|Change From Baseline in 36-item Short Form Health Survey (SF-36) Physical Functioning Domain at Week 24|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||units on a scale||Standard Error|Least Squares Mean
853229|NCT01212770|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 16|"The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included. LOCF was used.||units on a scale||Standard Error|Least Squares Mean
853230|NCT01212770|Secondary|Change From Baseline in the Disease Activity Score (DAS28) at Week 16|"The DAS28 measures the severity of disease at a specific time and is derived from the following variables:
28 tender joint count
28 swollen joint count, which do not include the distal interphalangeal (DIP) joints, the hip joint, or the joints below the knee;
C-reactive protein (CRP)
Patient's global assessment of disease activity.
DAS28(CRP) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included. LOCF was used.||units on a scale||Standard Error|Least Squares Mean
853231|NCT01212770|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 16|"The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:
28 tender joint count (TJC),
28 swollen joint count (SJC),
Patient's Global Assessment of Disease Activity measured on a 10 cm visual analog scale (VAS), where 0 cm = lowest disease activity and 10 cm = highest;
Physician's Global Assessment of Disease Activity -measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest.
The CDAI score ranges from 0-76 where lower scores indicate less disease activity.
The following thresholds of disease activity have been defined for the CDAI: Remission: ≤ 2.8 Low Disease Activity: > 2.8 and ≤ 10 Moderate Disease Activity: > 10 and ≤ 22 High Disease Activity: > 22."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included. LOCF was used.||units on a scale||Standard Error|Least Squares Mean
853232|NCT01212770|Secondary|Change From Baseline in Dactylitis Severity Score at Week 16|Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Baseline and Week 16|Full analysis set. Participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) and at least 1 postbaseline value at or prior to Week 16 are included. LOCF was used.||units on a scale||Standard Error|Least Squares Mean
853233|NCT01212770|Secondary|Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 16|"The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):
1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right.
The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses."|Baseline and Week 16|Full analysis set; participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) and at least 1 postbaseline value at or prior to Week 16 are included; LOCF was used.||units on a scale||Standard Error|Least Squares Mean
853234|NCT01212770|Secondary|Change From Baseline in Patient’s Assessment of Pain at Week 16|"The participant was asked to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents no pain, and the right-hand boundary (score = 100 mm) represents pain as severe as can be imagined. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included; LOCF was used.||mm||Standard Error|Least Squares Mean
853235|NCT01212770|Secondary|Percentage of Participants Achieving a ≥ 75% Improvement in Psoriasis Area and Severity Index Score (PASI75) at Week 16|"The percentage of participants with Baseline psoriasis body surface area (BSA) involvement ≥ 3% who achieved 75% or greater improvement from Baseline in Psoriasis Area and Severity Index (PASI) score after 16 weeks of treatment.
The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by erythema (reddening), induration (plaque thickness) and desquamation (scaling) scored on a scale from 0 (none) to 4 (very severe), together with the percentage of the area affected, rated on a scale from 0 (no involvement) to 6 (90% to 100% involvement). PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease."|Baseline and Week 16|Full analysis set; participants with a baseline psoriasis involvement ≥ 3% of BSA are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
853236|NCT01212770|Secondary|Percentage of Participants With a Modified Psoriatic Arthritis Response Criteria (PsARC) Response at Week 16|"Modified PsARC response is defined as improvement in at least 2 of the 4 measures, at least one of which must be tender joint count or swollen joint count, and no worsening in any of the 4 measures:
78 tender joint count,
76 swollen joint count,
Patient global assessment of disease activity, measured on a 100 mm visual Analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest;
Physician global assessment of disease activity, measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest.
Improvement or worsening in joint counts is defined as decrease or increase, respectively, from baseline by ≥ 30%, and improvement or worsening in global assessments is defined as decrease or increase, respectively, from baseline by ≥ 20 mm VAS."|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
853237|NCT01212770|Secondary|Change From Baseline in 36-item Short Form Health Survey (SF-36) Physical Functioning Domain at Week 16|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included; LOCF was used.||units on a scale||Standard Error|Least Squares Mean
853238|NCT01212770|Secondary|Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 24|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||units on a scale||Standard Error|Least Squares Mean
853239|NCT01212770|Secondary|Percentage of Participants With an ACR 20 Response at Week 24|"Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:
≥ 20% improvement in 78 tender joint count;
≥ 20% improvement in 76 swollen joint count; and
≥ 20% improvement in at least 3 of the 5 following parameters:
Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
Patient's global assessment of disease activity (measured on a 100 mm VAS);
Physician's global assessment of disease activity (measured on a 100 mm VAS);
Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));
C-Reactive Protein."|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
853240|NCT01212770|Secondary|Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 16|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included; Last observation carried forward (LOCF) imputation was used.||units on a scale||Standard Error|Least Squares Mean
853241|NCT01212770|Primary|Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 16|"Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:
≥ 20% improvement in 78 tender joint count;
≥ 20% improvement in 76 swollen joint count; and
≥ 20% improvement in at least 3 of the 5 following parameters:
Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
Patient's global assessment of disease activity (measured on a 100 mm VAS);
Physician's global assessment of disease activity (measured on a 100 mm VAS);
Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));
C-Reactive Protein."|Baseline and Week 16|Full analysis set consisting of all participants randomized as specified in the protocol. Participants who withdrew early or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
853242|NCT01196416|Secondary|Toxicity as Assessed by NCI CTCAE v. 4.0|Reported by type, frequency and severity.- Please see adverse events section.|Up to 30 days post-treatment||||||
853243|NCT01196416|Secondary|Progression-free Survival (Phase II)|Progression-free survival curves will be generated using Kaplan-Meier methodology.|Time from start of treatment to time of progression or death, whichever occurs first, assessed up to 2 years||||||
853244|NCT01196416|Secondary|Presence or Absence of Markers of Pathway Inhibition in Patient Tumors (Phase Ib)|The association of response or clinical benefit with the presence or absence of markers of pathway inhibition in patient tumors will be tested using Fisher's exact test.|2 weeks||||||
853245|NCT01196416|Secondary|Pharmacokinetics of Gamma-secretase Inhibitor RO4929097 in Combination With Temozolomide (Phase IB)||At baseline, and at days 1, 2, and 3 of courses 1 and 2||||||
853250|NCT01196416|Primary|Overall Objective Response|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression|From the time measurement criteria are met for CR or PR until the first date that recurrent or progressive disease is objectively documented, assessed up to 2 years|||Participants|||Count of Participants
853251|NCT01192295|Secondary|Pharmacokinetics (PK) Data of Oxycodone Hydrochloride Controlled-release Tablets|Plasma concentration data were characterized for a population PK model of oxycodone hydrochloride controlled-release tablets in opioid tolerant pediatric patients. Plasma samples were collected after the first dose on day 1 (one sample 2 to 4 hours after the dose and 1 sample 4 to 6 hours after the dose with approximately 2 hours between the samples), and immediately predose (morning or evening dose) and 2 to 4 hours after that dose at visit 2 and/or visit 3; a total of 4 to 6 samples were collected.|Day 1, week 2, and week 4||||||
853252|NCT01192295|Secondary|Parent/ Caregiver Assessed Functional Disability Inventory (FDI) for Patients Aged ≥ 12 to ≤ 16 Years|The FDI is a validated tool used to evaluate the degree to which children have reduced physical and psychosocial functioning because of their pain difficulties in the previous 2 weeks. The FDI comprises 15 items. Responses to each item were scored using a 5-point Likert scale. The individual scores are: (0) no trouble, (1) a little trouble, (2) some trouble, (3) a lot of trouble, and (4) impossible. A total score (ranging from 0 to 60) for the 15 items was calculated, with lower scores indicating less functional disability. The FDI was performed by the parent/ caregiver.|Baseline to week 4|The safety population was the group of patients who received at least 1 dose of study drug during the study.||units on a scale||Standard Deviation|Mean
853253|NCT01192295|Secondary|Parent/ Caregiver Assessed Functional Disability Inventory (FDI) for Patients Aged 6 to < 12 Years|The FDI is a validated tool used to evaluate the degree to which children have reduced physical and psychosocial functioning because of their pain difficulties in the previous 2 weeks. The FDI comprises 15 items. Responses to each item were scored using a 5-point Likert scale. The individual scores are: (0) no trouble, (1) a little trouble, (2) some trouble, (3) a lot of trouble, and (4) impossible. A total score (ranging from 0 to 60) for the 15 items was calculated, with lower scores indicating less functional disability. The FDI was performed by the parent/ caregiver.|Baseline to week 4|The safety population was the group of patients who received at least 1 dose of study drug during the study.||units on a scale||Standard Deviation|Mean
853254|NCT01192295|Secondary|Parent/ Caregiver-Assessed Global Impression of Change (PGIC)|The PGIC rating score variable was collected on a 7-point scale ranging from 1 to 7 (where 1 = very much improved; and 7 = very much worse). The PGIC is designed to assess overall satisfaction with the treatment. The number and percent of parent/caregivers reporting each category of PGIC response at the final visit was summarized for the safety population within age group.|Baseline to week 4 or early discontinuation|The safety population was the group of patients who received at least 1 dose of study drug during the study.||participants|||Number
853255|NCT01192295|Secondary|Use of Supplemental Pain Medication|Supplemental opioid and nonopioid pain medications were permitted during the study as deemed appropriate by the investigator. The dose of supplemental analgesic medication allowed was at the discretion of the investigator and within appropriate dose ranges for age and weight.|Baseline to week 4|The safety population was the group of patients who received at least 1 dose of study drug during the study.||participants|||Number
853256|NCT01192295|Secondary|Pain Right Now Assessment by Patients Aged ≥ 12 to ≤ 16 Years|Pain right now was assessed by patients aged ≥ 12 to ≤ 16 years using the 100-mm visual analogue scale (VAS). The 100-mm VAS is a 100-mm line with 1 end marked “no pain” and the opposite end marked as “pain as bad as it could be.” The patient was asked to make a mark on that line indicating his or her level of pain. The pain right now 100-mm VAS score was defined as the distance (in mm) from the “no pain” end to the patient’s mark. The scale is measured on a 100 mm line: a 0 means no pain and bigger numbers indicate more pain. Pain right now was assessed by the patient at screening; after the first dose; and, thereafter, twice daily during the AM and PM, approximately at the time of each (morning and evening) dose of oxycodone HCl CR tablets during the study treatment.|Baseline to week 4|The safety population was the group of patients who received at least 1 dose of study drug during the study.||units on a scale||Standard Deviation|Mean
853257|NCT01192295|Secondary|Pain Right Now Assessment by Patients Aged 6 to < 12 Years|Pain right now was assessed by patients aged 6 to <12 years using the Faces of Pain Scale-Revised (FPS-R). The FPS-R is a horizontal row of 6 faces representing pain intensity, with “no hurt” at the far left and “hurts worst” at the far right; the 6 intensities are scored as 0, 2, 4, 6, 8, or 10 (the patient was not shown the numbers associated with the faces). A score of 0 means no pain, and a 10 means very much pain. Pain right now was assessed by the patient at screening; after the first dose; and, thereafter, twice daily during the AM and PM, approximately at the time of each (morning and evening) dose of oxycodone HCl CR tablets during the study treatment.|Baseline to week 4|The safety population was the group of patients who received at least 1 dose of study drug during the study.||units on a scale||Standard Deviation|Mean
853258|NCT01192295|Primary|The Number of Participants With Adverse Events as a Measure of Safety.|Safety assessments consisted of reports of AEs, physical examinations, clinical laboratory test results, vital signs measurements, pulse oximetry (SpO2), and somnolence assessments. Safety variables were summarized descriptively within age group for the safety population.|Up to 4 weeks (during the study) and 7-10 days poststudy (safety follow-up assessment).|The safety population was the group of patients who received at least 1 dose of study drug during the study.||participants|||Number
853325|NCT01108757|Primary|Number of Participants With Urinary Tract Infection|Urinary tract infection diagnosis was obtained after confirmation with urine culture microbiology report. Infection was defined as >100,000 colony forming units/mL|7 days following catheter removal|Study terminated early.||Participants|||Count of Participants
853354|NCT01009515|Secondary|Time to Progression|The time from treatment initiation to disease progression or death by any cause. Progression is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by physical exam or computerized tomography (CT): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|2 years|The 16 patients who completed treatment were evaluable for progression-free survival.||weeks||95% Confidence Interval|Median
853355|NCT01009515|Secondary|Safety Profile|All toxicities encountered during the study by patients who receive at least one on-study treatment will be graded according to the NCI CTCAE (Version 3.0). The number of patients experiencing adverse events will be reported according to grade.|Up to 30 days after last on-study treatment, for up to 2 years|All patients who had received at least one dose of on-study treatment were evaluable for toxicity.||participants|||Number
853356|NCT01009515|Secondary|Overall Survival|The time from treatment initiation to death by any cause.|2 years|The 16 patients who completed treatment were evaluable for survival analysis.||weeks||95% Confidence Interval|Median
853357|NCT01009515|Primary|Objective Response Rate (ORR)|Tumor response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by physical exam and/or computerized tomography (CT): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The Objective Response Rate (ORR) is the sum of the percentages of patients achieving CR or PR.|6 months|The 16 patients who completed treatment were evaluable for the endpoint of overall response rate.||participants|||Number
853360|NCT00996840|Secondary|Maximum Observed Concentration (Cmax) of SB-681323|Absolute values of the Cmax of SB-681323 were reported. PK samples were collected for cohort 1 and 3 at Day 1 (pre-dose, 4, 4.25, 5, 6, 8, 12, 18h), Day 2 (pre-dose and 4h), Day 3 (0, 4, 24, 48h) and for cohort 2 and 4 at Day 1 (pre-dose), Day (pre-dose), Day 3 (pre-dose, 24h 10 min, 24h 45min, 27, 34, 40, 80 h since doing on Day 3).|For cohort 1 and 3: Day 1 (pre-dose, 4, 4.25, 5, 6, 8, 12, 18h), Day 2 (pre-dose and 4h), Day 3 (0, 4, 24, 48h). For cohort 2 and 4: Day 1 (pre-dose), Day (pre-dose), Day 3 (pre-dose, 24h 10 min, 24h 45min, 27, 34, 40, 80 h since doing on Day 3)|PK population. Only those participants available at the specified time points were analyzed.||ng/mL||95% Confidence Interval|Geometric Mean
853361|NCT00996840|Secondary|Mean Average Concentration (Cavg) of SB-681323|Absolute values of mean Cavg of SB-681323 were reported. PK samples were collected for cohort 1 and 3 at Day 1 (pre-dose, 4, 4.25, 5, 6, 8, 12, 18h), Day 2 (pre-dose and 4h), Day 3 (0, 4, 24, 48h) and for cohort 2 and 4 at Day 1 (pre-dose), Day (pre-dose), Day 3 (pre-dose, 24h 10 min, 24h 45min, 27, 34, 40, 80 h since doing on Day 3).|For cohort 1 and 3: Day 1 (pre-dose, 4, 4.25, 5, 6, 8, 12, 18h), Day 2 (pre-dose and 4h), Day 3 (0, 4, 24, 48h). For cohort 2 and 4: Day 1 (pre-dose), Day (pre-dose), Day 3 (pre-dose, 24h 10minutes [min], 24h 45min, 27, 34, 40, 80 h since doing on Day 3)|PK Population. Only those participants available at the specified time points were analyzed.||ng/mL||95% Confidence Interval|Geometric Mean
853362|NCT00996840|Secondary|Mean Area Under the Concentration-time Curve From Zero (Pre-dose) to 24 Hours (AUC0-24)|Absolute values of the mean AUC 0-24 of SB-681323 were reported. PK samples were collected for cohort 1 and 3 at Day 1 (pre-dose, 4, 4.25, 5, 6, 8, 12, 18h), Day 2 (pre-dose and 4h), Day 3 (0, 4, 24, 48h) and for cohort 2 and 4 at Day 1 (pre-dose), Day (pre-dose), Day 3 (pre-dose, 24h10minutes [min], 24h45min, 27, 34, 40, 80 h since doing on Day 3).|For cohort 1 and 3: Day 1 (pre-dose, 4, 4.25, 5, 6, 8, 12, 18h), Day 2 (pre-dose and 4h), Day 3 (0, 4, 24, 48h). For cohort 2 and 4: Day 1 (pre-dose), Day (pre-dose), Day 3 (pre-dose)|Pharmacokinetic (PK) population was defined as patients in the ‘All Subjects’ population for whom a pharmacokinetic sample was obtained and analyzed. Note: Due to some placebo patients PK samples being assayed in error, the above PK population definition was adjusted to also exclude any patient receiving Placebo.||h*ng/mL||95% Confidence Interval|Geometric Mean
853363|NCT00996840|Secondary|Markers of Lung Epithelial Cell Injury: Mean Myeloperoxidase (MPO) Levels|Serum samples were collected at 6, 12, 18, 24, 48, 72 and 96 h since first dose on Day 1. Mean absolute values of MPO levels at these specified time points were reported.|6, 12, 18, 24, 48, 72 and 96 h since first dose on Day 1|PD Population. Only those participants available at the specified time points were analyzed.||pg/mL||95% Confidence Interval|Geometric Mean
853364|NCT00996840|Secondary|Markers of Endothelial Cell/Neutrophil Interaction: Mean Soluble Tumor Necrosis Factor Receptors-I|Samples were collected at 6, 12, 18, 24, 48, 72 and 96 h since first dose on Day 1. Mean absolute values of soluble tumor necrosis factor receptors-I levels at these specified time points were reported.|6, 12, 18, 24, 48, 72 and 96 h since first dose on Day 1|PD Population. Only those participants available at the specified time points were analyzed.||pg/mL||95% Confidence Interval|Geometric Mean
853365|NCT00996840|Secondary|Mean Serum C-Reactive Protein (CRP) Levels|Serum samples were collected at 6, 12, 18, 24, 48, 72 and 96 h since first dose on Day 1. Mean absolute values of serum CRP levels at these specified time points were reported.|6, 12, 18, 24, 48, 72 and 96 h since first dose on Day 1|PD Population. Only those participants available at the specified time points were analyzed.||mg/L||95% Confidence Interval|Geometric Mean
853366|NCT00996840|Secondary|Mean Serum CXCL8 (Interleuin-8) Levels|Serum samples were collected at 6, 12, 18, 24, 48, 72 and 96 h since first dose on Day 1. Mean absolute values of Serum CXCL8 (Interleuin-8) levels at these specified time points were reported.|6, 12, 18, 24, 48, 72 and 96 h since first dose on Day 1|PD Population. Only those participants available at the specified time points were analyzed.||pg/ml||95% Confidence Interval|Geometric Mean
853367|NCT00996840|Secondary|Mean Serum Interleukin-6 Levels|Serum samples were collected at 6, 12, 18, 24, 48, 72 and 96 h since first dose on Day 1. Mean absolute values of Serum interleukin-6 levels at these specified time oints were reported.|6, 12, 18, 24, 48, 72 and 96 h since first dose on Day 1|Pharmacodynamic (PD) Population was defined as patients in the ‘All Subjects’ population for whom a pharmacodynamic sample was obtained and analysed (Flow Cytometry data were excluded from the definition of pharmacodynamic sample). Only those participants available at the specified time points were analyzed.||Picogram per milliliter (pg/mL)||95% Confidence Interval|Geometric Mean
853368|NCT00996840|Primary|Number of Participants With Any Adverse Events (AE) and Serious Adverse Events (SAE)|AE was defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE include AEs those result in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.|Up to Follow-up (Day 7)|All subject population.||Participants|||Count of Participants
853369|NCT00996840|Primary|Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals|12-lead ECGs were obtained at each timepoint during the study using an ECG machine that automatically calculated the heart rate and measures RR, PR, QRS, QT, and QTc intervals. Absolute mean values of PR, QRS, QT, and QTcB, QTcF, RR intervals were reported.|Day 2, pre-dose, Day 3, pre-dose, Day 3, 24 h and Follow-up (Day 7)|All subject population. Only those participants available at the specified time points were analyzed.||Milliseconds||Standard Deviation|Mean
853370|NCT00996840|Primary|Vital Signs: Mean Oxygen Requirement (FiO2) Via Pulse Oximetry|Assessment of mean FiO2 via pulse oximetry was planned for cohort 1 and 3 at Day 1 (4 h), Day 2 (pre-dose) and Day 3 (pre-dose and 24 h) and for cohort 2 and 4: Day 2 (pre-dose) and Day 3 (pre-dose and 24 h). However, the analyzable data was not collected for this parameter.|For Cohort 1 and 3: “Day 1, 4 h”, “Day 2, pre-dose”, “Day 3, pre-dose and 24 h”; for Cohort 2 and 4: “Day 2, pre-dose”, and “Day 3, pre-dose and 24 h”|All subject population. Data was not collected for this parameter.|||||
853371|NCT00996840|Primary|Vital Signs: Mean Level of Peak and Plateau Ventilator Pressures|Assessment of mean level of peak and plateau ventilator pressures was planned for cohort 1 and 3 at Day 1 (4 h), Day 2 (pre-dose) and Day 3 (pre-dose and 24 h) and for cohort 2 and 4: Day 2 (pre-dose) and Day 3 (pre-dose and 24 h). However, the analyzable data was not collected for this parameter.|For Cohort 1 and 3: “Day 1, 4 h”, “Day 2, pre-dose”, “Day 3, pre-dose and 24 h”; for Cohort 2 and 4: “Day 2, pre-dose”, and “Day 3, pre-dose and 24 h”|All subject population. Data was not collected for this parameter.|||||
853372|NCT00996840|Primary|Vital Signs: Mean Level of Positive End Expiratory Pressure|Assessment of level of positive end expiratory pressure was planned for cohort 1 and 3 at Day 1 (4 h), Day 2 (pre-dose) and Day 3 (pre-dose and 24 h) and for cohort 2 and 4: Day 2 (pre-dose) and Day 3 (pre-dose and 24 h). However, the analyzable data was not collected for this parameter.|For Cohort 1 and 3: “Day 1, 4 h”, “Day 2, pre-dose”, “Day 3, pre-dose and 24 h”; for Cohort 2 and 4: “Day 2, pre-dose”, and “Day 3, pre-dose and 24 h”|All subject population. Data was not collected for this parameter.|||||
853373|NCT00996840|Primary|Vital Signs: Mean Oxygen Saturation (SaO2) Via Pulse Oximetry|Assessment of SaO2 via pulse oximetry was planned for cohort 1 and 3 at Day 1 (4 h), Day 2 (pre-dose) and Day 3 (pre-dose and 24 h) and for cohort 2 and 4: Day 2 (pre-dose) and Day 3 (pre-dose and 24 h). However, the analyzable data was not collected for this parameter.|For Cohort 1 and 3: “Day 1, 4 h”, “Day 2, pre-dose”, “Day 3, pre-dose and 24 h”; for Cohort 2 and 4: “Day 2, pre-dose”, and “Day 3, pre-dose and 24 h”|All subject population. Data was not collected for this parameter.|||||
853374|NCT00996840|Primary|Vital Sign: Mean Percent Oxygen (O2) in Blood|Absolute values of mean percent O2 in blood were reported.|"For Cohort 1 and 3: “Day 1, 4 h”, “Day 2, pre-dose”, “Day 3, pre-dose and 24 h” and Follow up (Day 7); for Cohort 2 and 4: “Day 2, pre-dose”, “Day 3, pre-dose and 24 h”, and Follow up (Day 7)"|All subject population. Only those participants available at the specified time points were analyzed.||Percent O2||Standard Deviation|Mean
853375|NCT00996840|Primary|Vital Parameter: Mean Heart Rate|Absolute values of mean heart rate were reported.|"For Cohort 1 and 3: “Day 1, 4 h”, “Day 2, pre-dose”, “Day 3, pre-dose and 24 h” and Follow up (Day 7); for Cohort 2 and 4: “Day 2, pre-dose”, “Day 3, pre-dose and 24 h”, and Follow up (Day 7)"|All subject population. Only those participants available at the specified time points were analyzed.||Beats per minute||Standard Deviation|Mean
853376|NCT00996840|Primary|Vital Parameter- Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Absolute values of SBP and DBP were reported.|"For Cohort 1 and 3: “Day 1, 4 h”, “Day 2, pre-dose”, “Day 3, pre-dose and 24 h” and Follow up (Day 7); for Cohort 2 and 4: “Day 2, pre-dose”, “Day 3, pre-dose and 24 h”, and Follow up (Day 7)"|All subject population. Only those participants available at the specified time points were analyzed.||Millimeter of Mercury (mmHg)||Standard Deviation|Mean
853377|NCT00996840|Primary|Mean Clinical Chemistry Parameters-Blood pH at Screening|Absolute values of Blood pH at screening were reported as clinical chemistry parameter.|Screening|All subject population. Only those participants available at the specified time points were analyzed.||pH Units||Standard Deviation|Mean
853378|NCT00996840|Primary|Mean Clinical Chemistry Parameters-estradiol|Absolute values of Estradiol were reported. If sample for clinical chemistry test had been obtained for standard of care within ± 4 h of the planned assessment then it was not collected at the planned assessment time point.|Day 1 (pre-dose) and Day 3 (24 h)|All subject population. Only those participants available at the specified time points were analyzed. Data were not collected from participants in Cohort 2-SB-681323, 7.5 mg, 24 h, Cohort 3-SB-681323, 7.5 mg, 4 h, and Cohort 4-SB-681323, 10 mg, 24 h.||Picomole per liter||Standard Deviation|Mean
853379|NCT00996840|Primary|Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)|Absolute values of calcium, chloride, glucose, bicarbonate, potassium, sodium and Urea/BUN were reported. If sample for clinical chemistry test had been obtained for standard of care within ± 4 h of the planned assessment then it was not collected at the planned assessment time point.|"“Day 2, pre-dose, Day 3, pre-dose, Day 3, 24 h and Follow up (Day 7)"|All subject population. Only those participants available at the specified time points were analyzed.||Millimole per liter||Standard Deviation|Mean
853380|NCT00996840|Primary|Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid|Absolute values of direct bilirubin, total bilirubin, creatinine and uric acid were reported. If sample for clinical chemistry test had been obtained for standard of care within ± 4 h of the planned assessment then it was not collected at the planned assessment time point.|"“Day 2, pre-dose, Day 3, pre-dose, Day 3, 24 h and Follow up (Day 7)"|All subject population. Only those participants available at the specified time points were analyzed.||Micromol per liter||Standard Deviation|Mean
853381|NCT00996840|Primary|Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase|Absolute values of alkaline phosphatase, alanine amino transferase, aspartate amino transferase, creatine kinase and gamma glutamyl transferase were reported. If sample for clinical chemistry test had been obtained for standard of care within ± 4 h of the planned assessment then it was not collected at the planned assessment time point.|"“Day 2, pre-dose, Day 3, pre-dose, Day 3, 24 h and Follow up (Day 7)"|All subject population. Only those participants available at the specified time points were analyzed.||International units per liter (IU/L)||Standard Deviation|Mean
853382|NCT00996840|Primary|Mean Clinical Chemistry Parameters- Albumin and Total Protein|Absolute values of albumin and total protein were reported. If sample for clinical chemistry test had been obtained for standard of care within ± 4 h of the planned assessment then it was not collected at the planned assessment time point.|"“Day 2, pre-dose, Day 3, pre-dose, Day 3, 24 h and Follow up (Day 7)"|All subject population. Only those participants available at the specified time points were analyzed.||g/L||Standard Deviation|Mean
853383|NCT00996840|Primary|Mean Hematology Parameters-reticulocytes, Red Blood Cell Count|Absolute values of reticulocytes and red blood cell count were reported. If sample for hematology test had been obtained for standard of care within ± 4 h of the planned assessment then it was not collected at the planned assessment time point.|"“Day 2, pre-dose, Day 3, pre-dose, Day 3, 24 h and Follow up (Day 7)"|All subject population. Only those participants available at the specified time points were analyzed.||Trillion cells per liter (TI/L)||Standard Deviation|Mean
853384|NCT00996840|Primary|Hematology Parameters-Mean Corpuscle Volume|Absolute values of mean corpuscle volume were reported. If sample for hematology test had been obtained for standard of care within ± 4 h of the planned assessment then it was not collected at the planned assessment time point.|"“Day 2, pre-dose, Day 3, pre-dose, Day 3, 24 h and Follow up (Day 7)"|All subject population. Only those participants available at the specified time points were analyzed.||Femtoliter||Standard Deviation|Mean
853385|NCT00996840|Primary|Mean Hematology Parameters- Mean Corpuscle Hemoglobin|Hematology parameter mean corpuscle hemoglobin was reported. If sample for hematology test had been obtained for standard of care within ± 4 h of the planned assessment then it was not collected at the planned assessment time point.|"“Day 2, pre-dose, Day 3, pre-dose, Day 3, 24 h and Follow up (Day 7)"|All subject population. Only those participants available at the specified time points were analyzed.||Picogram (pg)||Standard Deviation|Mean
853386|NCT00996840|Primary|Mean Hematology Parameters- Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC)|Mean hematology parameters including hemoglobin, MCHC were reported. If sample for hematology test had been obtained for standard of care within ± 4 h of the planned assessment then it was not collected at the planned assessment time point.|"“Day 2, pre-dose, Day 3, pre-dose, Day 3, 24 h and Follow up (Day 7)"|All subject population. Only those participants available at the specified time points were analyzed.||Grams per liter (g/L)||Standard Deviation|Mean
853387|NCT00996840|Primary|Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count|Mean hematology parameters including basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count, white blood cell count were reported. If sample for hematology test had been obtained for standard of care within ± 4 h of the planned assessment then it was not collected at the planned assessment time point.|"“Day 2, pre-dose, Day 3, pre-dose, Day 3, 24 h and Follow up (Day 7)"|All subject Population comprised of as all participant who received at least one dose of study medication. Only those participants available at the specified time points were analyzed.||Giga cells per liter||Standard Deviation|Mean
853432|NCT00866359|Secondary|Pain of Genital Ulcers as Measured by Visual Analog Scale (VAS) at Day 169|A 100-mm VAS pain scale for genital ulcers was completed by the participant at timepoints specified in the protocol. Each 100-mm VAS was presented to the participant on a single sheet of bond paper. The participant was asked to draw a single line perpendicular to the VAS line at the point that represented the severity of their pain during the previous week, with 0 mm (the left-hand end of the scale) representing no pain and 100 mm (the right-hand end of the scale) representing the worst pain imaginable. The distance of the perpendicular line from the left-hand end of the scale was measured by ruler and recorded. When responding to a VAS item, participants specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.|Day 1 to Day 169|Not analyzed due to low numbers of genital ulcers; not considered meaningful.|||||
853424|NCT00866359|Secondary|Summary of Treatment Emergent Adverse Events During the Active Treatment-Extension Phase|A Treatment Emergent Adverse Event (TEAE) is as any AE occurring or worsening on or after the first treatment of any study drug, and within 28 days after the last dose of the last study drug. A treatment related toxicity was considered by the investigator to be not suspected or suspected. Severity grades according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE) on a 1-5 scale: Grade 1= Mild AE, Grade 2= Moderate AE, Grade 3= Severe AE, Grade 4= Life-threatening or disabling AE, Grade 5=Death related to AE.|Day 1 to Day 197; maximum exposure was 25.1 weeks|Safety analyses for the apremilast-exposure period was based on the apremilast participants as treated (AAT) Population, and included those who were randomized (at the randomization visit) or switched (at the Day 85 visit) to apremilast 30 mg BID, and received at least one dose of apremilast after the initial randomization or switch to 30 mg BID.||particpants|||Number
853425|NCT00866359|Secondary|Change From Baseline in the Disease Activity as Measured by BD Current Activity Form/Index Score on Day 197|The Behçet's Disease Current Activity Index consists of three component scores, a participant's perception of disease activity, a clinician's overall perception of disease activity and a Behçet's Disease Current Activity Index Score. The score ranges from 0 to 12. A higher score indicates higher level of disease activity (worsening) and a negative change from baseline indicates improvement.|Day 1 to Day 197|Includes participants who entered the Observational Follow-up Phase from either the Treatment Phase or the Extension Phase||units on a scale||Standard Deviation|Mean
853426|NCT00866359|Secondary|Pain of Genital Ulcers as Measured by Visual Analog Scale (VAS) at Day 197|A 100-mm VAS pain scale for genital ulcers was completed by the participant at timepoints specified in the protocol. Each 100-mm VAS was presented to the participant on a single sheet of bond paper. The participant was asked to draw a single line perpendicular to the VAS line at the point that represented the severity of their pain during the previous week, with 0 mm (the left-hand end of the scale) representing no pain and 100 mm (the right-hand end of the scale) representing the worst pain imaginable. The distance of the perpendicular line from the left-hand end of the scale was measured by ruler and recorded. When responding to a VAS item, participants specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.|Day 1 to Day 197|Not analyzed due to low numbers of genital ulcers; not considered meaningful.|||||
853427|NCT00866359|Other Pre-specified|Percentage of Participants Who Were Genital Ulcer-free (Complete Response)|The percentage of participants who were genital ulcer-free (complete response: free from active genital ulcers)|Day 1 to Day 197|Intent to Treat (ITT) = all randomized participants with at least one genital ulcer at baseline. A Last Observation Carried Forward (LOCF) approach was applied for participants terminated early. If a participant had no post-baseline genital ulcer assessment, the baseline value was carried forward for calculation.||percentage of participants|||Number
853428|NCT00866359|Secondary|Pain of Oral Ulcers as Measured by VAS (VAS Score) at Day 197|A 100-mm VAS pain scale for oral ulcers was completed by the participant at timepoints specified in the protocol. Each 100-mm VAS was presented to the participant on a single sheet of bond paper. The participant was asked to draw a single line perpendicular to the VAS line at the point that represented the severity of their pain during the previous week, with 0 mm (the left-hand end of the scale) representing no pain and 100 mm (the right-hand end of the scale) representing the worst pain imaginable. The distance of the perpendicular line from the left-hand end of the scale was measured by ruler and recorded. When responding to a VAS item, participants specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.|Day 197|Includes participants who entered the Observational Follow-up Phase from either the Treatment Phase or the Extension Phase.||units on a scale||Standard Deviation|Mean
853429|NCT00866359|Secondary|Number of Oral Ulcers at Day 197|The number of oral ulcers were counted at each visit and at the end of the treatment period (starting point was at baseline).|Day 197|Includes participants who entered the Observational Follow-up Phase from either the Treatment Phase or the Extension Phase||ulcers/participants||Standard Deviation|Mean
853430|NCT00866359|Secondary|Number of New Manifestations of Behçet’s Disease or Flare That Were Not Present at Day 1|"A flare was defined as the development of new manifestations of BD or worsening of existing disease, meeting the following criteria:
Organ involvement: any major organ involvement (eg, central nervous system, gastrointestinal tract);
Oral/genital ulcers: ≥ 100% increase in the number of oral or genital ulcers from Day 1 or a minimum increase of 3 in the number of oral or genital ulcers, whichever is greater;
Arthritis: ≥ 50% increase in the number of swollen joints, or a minimum increase of 3 swollen joints, whichever is greater;
Skin lesions (non-oral/genital ulcers): ≥ 50% increase in the total score of the Physician’s Global Assessment of Skin Lesions, or a minimum increase of 2 in the total score of the Physician’s Global Assessment of Skin Lesions, whichever is greater;
New onset or worsening of existing Behçet Disease-related inflammatory eye disease requiring initiation of immunosuppressive therapy (uveitis)."|Day 1 to Day 169|The ITT population included all randomized participants with at least one oral ulcer evaluation (including the baseline evaluation). A LOCF approach was applied for participants terminated early from the study. If a participant had no post-baseline oral ulcer assessment, the baseline value was carried forward for calculation.||participants|||Number
853431|NCT00866359|Secondary|Behçet's Disease (BD) Current Activity Index Form Score at Day 169|The Behçet's Disease Current Activity Index consists of three component scores, a participant's perception of disease activity, a clinician's overall perception of disease activity and a Behçet's Disease Current Activity Index Score. The score ranges from 0 to 12. A higher score indicates higher level of disease activity (worsening) and a negative change from baseline indicates improvement.|Day 169|The ITT population included all randomized participants with at least one oral ulcer evaluation (including the baseline evaluation). A LOCF approach was applied for participants terminated early from the study. If a participant had no post-baseline oral ulcer assessment, the baseline value was carried forward for calculation.||units on a scale||Standard Deviation|Mean
853433|NCT00866359|Other Pre-specified|Percentage of Participants Who Were Genital Ulcer-free (Complete Response) at Day 169|The percentage of participants who were genital ulcer-free (complete response: free from active genital ulcers)|Day 1 to Day 169|Intent to Treat (ITT) = all randomized participants with at least one genital ulcer at baseline visit. A Last Observation Carried Forward (LOCF) approach was applied for participants terminated early. If a participant had no post-baseline genital ulcer assessment, the baseline value was carried forward for calculation.||percentage of participants|||Number
853434|NCT00866359|Secondary|Pain of Oral Ulcers as Measured by VAS (VAS Score) at Day 169|A 100-mm VAS pain scale for oral ulcers was completed by the participant at timepoints specified in the protocol. Each 100-mm VAS was presented to the participant on a single sheet of bond paper. The participant was asked to draw a single line perpendicular to the VAS line at the point that represented the severity of their pain during the previous week, with 0 mm (the left-hand end of the scale) representing no pain and 100 mm (the right-hand end of the scale) representing the worst pain imaginable. The distance of the perpendicular line from the left-hand end of the scale was measured by ruler and recorded. When responding to a VAS item, participants specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.|Day 169|The ITT population included all randomized participants with at least one oral ulcer evaluation (including the baseline evaluation). A LOCF approach was applied for participants terminated early from the study. If a participant had no post-baseline oral ulcer assessment, the baseline value was carried forward for calculation.||units on a scale||Standard Deviation|Mean
853435|NCT00866359|Secondary|Number of Oral Ulcers at Day 169|The number of oral ulcers were counted at Day 169 in reference to the participants’ first day of active treatment (Day 1 or Day 85).|Day 169|The ITT population included all randomized participants with at least one oral ulcer evaluation (including the baseline evaluation). A LOCF approach was applied for participants terminated early from the study. If a participant had no post-baseline oral ulcer assessment, the baseline value was carried forward for calculation.||ulcers/participant||Standard Deviation|Mean
853436|NCT00866359|Secondary|Number of New Manifestations of Behçet’s Disease or Flare During the Placebo Controlled Treatment Phase|"A flare was defined as the development of new manifestations of BD or worsening of existing disease, meeting the following criteria:
Organ involvement: any major organ involvement (eg, central nervous system, gastrointestinal tract);
Oral/genital ulcers: ≥ 100% increase in the number of oral or genital ulcers from Day 1 or a minimum increase of 3 in the number of oral or genital ulcers, whichever is greater;
Arthritis: ≥ 50% increase in the number of swollen joints, or a minimum increase of 3 swollen joints, whichever is greater;
Skin lesions (non-oral/genital ulcers): ≥ 50% increase in the total score of the Physician’s Global Assessment of Skin Lesions, or a minimum increase of 2 in the total score of the Physician’s Global Assessment of Skin Lesions, whichever is greater'
New onset or worsening of existing Behçet Disease-related inflammatory eye disease requiring initiation of immunosuppressive therapy (uveitis)."|Day 1 to Day 85|Safety population included all participants who were randomized and received at least 1 dose of Investigational Product.||participants|||Number
853437|NCT00866359|Secondary|Number of Treatment Emergent Adverse Events (TEAE) During the Placebo Controlled Treatment Phase|A Treatment Emergent Adverse Event (TEAE) was defined as any AE occurring or worsening on or after the first treatment of any study drug, and within 28 days after the last dose of the last study drug. A treatment related toxicity was considered by the investigator to be not suspected or suspected. Severity grades according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE) on a 1-5 scale: Grade 1= Mild AE, Grade 2= Moderate AE, Grade 3= Severe AE, Grade 4= Life-threatening or disabling AE, Grade 5=Death related to AE.|Day 1 to Day 85; maximum exposure to study drug was 13 weeks during treatment phase|Safety Population defined as all participants who were randomized and received at least 1 dose of Investigational Product.||participants|||Number
853438|NCT00866359|Secondary|Change From Baseline in the Disease Activity as Measured by BD Current Activity Form/Index Score on Day 85|The Behçet's Disease Current Activity Index consists of three component scores, a participant's perception of disease activity, a clinician's overall perception of disease activity and a Behçet's Disease Current Activity Index Score. The score ranges from 0 to 12. A higher score indicates higher level of disease activity (worsening) and a negative change from baseline indicates improvement.|Day 1 to Day 85 or to early termination visit|The ITT population included all randomized participants with at least one oral ulcer evaluation (including the baseline evaluation). A LOCF approach was applied for participants terminated early from the study. If a participant had no post-baseline oral ulcer assessment, the baseline value was carried forward for calculation.||units on a scale||Standard Error|Least Squares Mean
853439|NCT00866359|Secondary|Percentage of Participants Who Were Oral Ulcer-free (Complete Response), or Whose Oral Ulcers Were Reduced by ≥ 50%, (Partial Response)|Comparison of the percentage of participants who were oral ulcer-free (complete response: free from active oral ulcers), or whose oral ulcers were reduced by ≥ 50%, (partial response) between the apremilast-treated and the placebo-treated groups. In this case, partial response also includes complete response.|Baseline and Day 85|The ITT population included all randomized participants with at least one oral ulcer evaluation (including the baseline evaluation). A LOCF approach was applied for participants terminated early from the study. If a participant had no post-baseline oral ulcer assessment, the baseline value was carried forward for calculation.||percentage of participants|||Number
853440|NCT00866359|Secondary|Sum of the Number Oral Ulcers, Genital Ulcers or Oral Plus Genital Ulcers at Day 85|Sum of the number oral ulcers, genital ulcers or oral plus genital ulcers at Day 85|Day 85|The ITT population included all randomized participants with at least one oral ulcer evaluation (including the baseline evaluation). A LOCF approach was applied for participants terminated early from the study. If a participant had no post-baseline oral ulcer assessment, the baseline value was carried forward for calculation.||Ulcers/participants||Standard Error|Least Squares Mean
853441|NCT00866359|Secondary|Area Under the Curve (AUC) for the Number of Oral Plus Genital Ulcers From Day 1 to 85|Area under curve (AUC) from Day 1 to Day 85 (AUC^85) for the number of oral plus genital ulcers per day was determined using the trapezoidal rule and divided by the days between the date of the last observation and baseline. The AUC was determined using the LOCF approach to impute missing values.|Day 1 to Day 85|The ITT population included all randomized participants with at least one oral ulcer evaluation (including the baseline evaluation). A LOCF approach was applied for participants terminated early from the study. If a participant had no post-baseline oral ulcer assessment, the baseline value was carried forward for calculation.||total AUC (#ulcers*days)||Standard Deviation|Mean
853442|NCT00866359|Secondary|Area Under the Curve for the Number of Genital Ulcers From Day 1 to 85|Area under curve (AUC^85) from Day 1 to Day 85 for the number of genital ulcers per day was not analyzed.|Day 1 to Day 85|No population analyzed due to small number of participants with genital ulcers; not considered meaningful.|||||
853454|NCT00832520|Primary|Change in Weight||8 weeks|There will be no publication, as this study was terminated after the original PI left employment with the institution, and because enrollment was low (13 of a target 59) which rendered planned statistical analyses impossible.|||||
853443|NCT00866359|Secondary|Area Under the Curve (AUC) for the Number of Oral Ulcers From Day 1 to 85|Area under curve (AUC^85) from Day 1 to Day 85 for the number of oral ulcers per day was determined using the trapezoidal rule and divided by the days between the date of the last observation and baseline. The AUC was determined using the LOCF approach to impute missing values.|Day 1 to Day 85|The ITT population included all randomized participants with at least one oral ulcer evaluation (including the baseline evaluation). A LOCF approach was applied for participants terminated early from the study. If a participant had no post-baseline oral ulcer assessment, the baseline value was carried forward for calculation.||total AUC (#ulcers*days)||Standard Error|Least Squares Mean
853444|NCT00866359|Secondary|Pain of Genital Ulcers as Measured by Visual Analog Scale (VAS) Scores at Day 85|A 100-mm VAS pain scale for genital ulcers was completed by the participant at timepoints specified in the protocol. Each 100-mm VAS was presented to the participant on a single sheet of bond paper. The participant was asked to draw a single line perpendicular to the VAS line at the point that represented the severity of their pain during the previous week, with 0 mm (the left-hand end of the scale) representing no pain and 100 mm (the right-hand end of the scale) representing the worst pain imaginable. The distance of the perpendicular line from the left-hand end of the scale was measured by ruler and recorded. When responding to a VAS item, participants specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.|Baseline to Day 85|Not analyzed due to low numbers of genital ulcers; not considered meaningful.|||||
853445|NCT00866359|Other Pre-specified|Percentage of Participants Who Were Genital Ulcer-free (Complete Response) at Day 85|The percentage of participants who were genital ulcer-free (complete response: free from active genital ulcers)|Baseline to Day 85|Intent to Treat (ITT) = all randomized participants with at least one genital ulcer at baseline. A Last Observation Carried Forward (LOCF) approach was applied for participants terminated early. If a participant had no post-baseline genital ulcer assessment, the baseline value was carried forward for calculation.||percentage of participants|||Number
853446|NCT00866359|Secondary|Pain of Oral Ulcers as Measured by Visual Analog Scale (VAS) at Day 85|A 100-mm VAS pain scale for oral ulcers was completed by the participant at timepoints specified in the protocol. Each 100-mm VAS was presented to the participant on a single sheet of bond paper. The participant was asked to draw a single line perpendicular to the VAS line at the point that represented the severity of their pain during the previous week, with 0 mm (the left-hand end of the scale) representing no pain and 100 mm (the right-hand end of the scale) representing the worst pain imaginable. The distance of the perpendicular line from the left-hand end of the scale was measured by ruler and recorded. When responding to a VAS item, participants specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.|Day 85|The ITT population included all randomized participants with at least one oral ulcer evaluation (including the baseline evaluation). A LOCF approach was applied for participants terminated early from the study. If a participant had no post-baseline oral ulcer assessment, the baseline value was carried forward for calculation.||units on a scale||Standard Error|Least Squares Mean
853447|NCT00866359|Primary|Number of Oral Ulcers at Day 85|The number of oral ulcers were counted at each visit and at the end of the treatment period (starting point was at baseline).|Day 85|Intent to Treat (ITT) = all randomized participants with at least one oral ulcer evaluation (including the baseline visit). A Last Observation Carried Forward (LOCF) approach was applied for participants terminated early. If a participant had no post-baseline oral ulcer assessment, the baseline value was carried forward for calculation.||ulcers/participants||Standard Error|Least Squares Mean
853448|NCT00832637|Secondary|Toxicity|Toxicity will be evaluated per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 4.0. Frequency and severity of adverse events will be tabulated using counts of frequently occurring, serious and severe events of interest (i.e. Grade 3 and Grade 4 adverse events).|Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition. An average of 24 weeks|||participants|||Number
853449|NCT00832637|Secondary|Median Survival Time (MST)|Survival is defined as the time from treatment initiation to death by any cause|2 years|||weeks||95% Confidence Interval|Median
853450|NCT00832637|Secondary|Time to Tumor Progression (TTP)|The time from treatment initiation to disease progression. Progression is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI): Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|2 years|||weeks||95% Confidence Interval|Median
853451|NCT00832637|Secondary|Overall Response Rate|"Overall response rate is defined as the percentage of patients achieving a complete response (CR) + partial response (PR) at 24 weeks following treatment.
Response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions."|24 weeks|||percentage of evaluable participants|||Number
853452|NCT00832637|Primary|Tumor Control Rate|"Rate of tumor control is defined as the percentage of patients achieving a complete response (CR) + partial response (PR) + stable disease (SD) at 24 weeks following treatment.
Response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions."|24 weeks|||percentage of evaluable participants|||Number
853453|NCT00832520|Secondary|To Determine if the Quality of Life Improves After Starting Mirtazapine||8 weeks||||||
853486|NCT00722865|Secondary|Safety|Toxicities are graded 1 (mild), 2 (moderate), 3 (severe), and 4 (life-threatening)|2 years|||Participants|||Count of Participants
853487|NCT00722865|Secondary|Overall Survival|Overall survival: patients are still alive.|2 years|||Participants|||Count of Participants
853488|NCT00722865|Secondary|Progression-free Survival|Progression-free survival: a patient lives with the disease but it does not get worse.|2 years and medium follow-up of 18 months|||percentage of participants||90% Confidence Interval|Number
853489|NCT00722865|Secondary|Overall Response Rate Using the Modified Cheson Criteria|Overall response = Complete response (CR) + Partial response (PR) CR = all previously enlarged fluorodeoxyglucose (FDG)-avid or positron emission tomography (PET)-positive lymph nodes regressed to normal size (<=1.5cm in greatest diameter) PR = >=50% decrease in SPD of up to six largest dominant masses, no increase in size of other nodes; FDG avid or PET positive before therapy, one or more nodes PET positive at previously involved site, or variably FDG avid or PET negative with regression at CT|2 years|||percentage of participants||90% Confidence Interval|Number
853490|NCT00722865|Primary|Failure-free Survival|Failure-free survival: the absence of relapse, non-relapse mortality or addition of another systemic therapy|2 years and median follow-up of 18 months|||percentage of participants||90% Confidence Interval|Number
853491|NCT00704496|Secondary|Improvement of Daytime Somnolence With Pseudoephedrine as Compared to Placebo|daytime sleepiness by subjective questionnaires|3 years|data disposed of and no longer in existence|||||
853492|NCT00704496|Primary|Improvement of Sleep Associated With the Use of Pseudoephedrine as Compared to the Placebo|sleep improvement by subjective questionnaires|3 years|data disposed of and no longer in existence|||||
853705|NCT02616250|Primary|Efficacy Variable: Percentage of Patients Defined as Success on the Global Rosacea Severity Grading Scale Called Investigator’s Global Assessment (IGA):|Percentage of patients defined as success as per scores of IGA; ie: clear (score=0) or almost clear (score=1)|week 12/Hour 3|Intent To Treat (ITT) Population||Participants|||Count of Participants
853565|NCT00619112|Secondary|Toxicity Associated With the Dose-intense Temozolomide Treatment Schedule as Assessed by NCI CTCAE v3.0||Study start was 10.31.2007. Enrollment was completed on 12/22/2011||||||
853566|NCT00619112|Primary|Efficacy, as Measured by 6-month Progression-free Survival, of the Dose-intense Temozolomide Treatment Schedule; This Endpoint Was Measured From the First Day of Treatment Until Progression or 6month Mark From Treatment Initiation.||Study start was 10.31.2007. Enrollment was completed on 12/22/2011|||percentage of participants|MRI of brain||Number
853654|NCT00208026|Secondary|Liver Function Tests||Each visit||||||
853655|NCT00208026|Secondary|Blood Urea Nitrogen and Creatinine||Each visit||||||
853656|NCT00208026|Secondary|Blood Electrolytes and Fasting Glucose||Each visit||||||
853657|NCT00208026|Secondary|Complete Blood Count With Differential||Each visit||||||
853658|NCT00208026|Primary|Transepidermal Water Loss||Each visit||||||
853659|NCT00208026|Primary|Pruritus Severity Assessment||Each visit||||||
853660|NCT00208026|Primary|Investigator's Global Evaluation of Disease (IGED)||Each visit||||||
853661|NCT00208026|Primary|Netherton Area and Severity Assessment (NASA)||Each visit||||||
853662|NCT00208026|Primary|Eczema Area and Severity Index (EASI)||Each visit||||||
853663|NCT00208026|Primary|Highest Peak Blood Concentration of Pimecrolimus Over All Study Visits|At each scheduled visit, blood concentration of pimecrolimus were obtained. This value reflects the amount of pimecrolimus in the blood. This is measured directly from the blood and provides an estimate of the degree of absorption of the treatment medication through the skin into the blood. Analysis was performed as intent-to-treat with last value carried forward, but no data points were missing.|Each visit up to 18 months|Only the highest peak level documented for the group is reported||ng/mL|||Number
853664|NCT00194129|Secondary|Change in Rate of Cocaine Use Disorders After Open-label Treatment With Lithium and Divalproex||Baseline to Month 6||||||
853665|NCT00194129|Secondary|Change in Rate of Cannabis Use Disorders After Open-label Treatment With Lithium and Divalproex||Baseline to Month 6||||||
853666|NCT00194129|Secondary|Change in Rate of Alcohol Use Disorders After Open-label Treatment With Lithium and Divalproex||Baseline to Month 6||||||
853667|NCT00194129|Secondary|Time to Treatment for Emerging Symptoms of a Depressive Episode||Up to 6 months||||||
853668|NCT00194129|Secondary|Time to Treatment for Emerging Symptoms of a Manic/Hypomanic/Mixed Episode||Up to 6 months||||||
853669|NCT00194129|Primary|Time to Treatment for Emerging Symptoms of a Mood Relapse|A relapse is a return to either a depressive, manic, hypomanic or mixed episode after a period of not have any symptoms.|Up to 6 months|||weeks||95% Confidence Interval|Median
853694|NCT00045708|Primary|Response Rate of Patients at the MTD|"Complete Response: Complete disappearance of all tumor on MRI scan, off all glucocorticoids with stable/improving neurologic exam for min4 wks.
Partial Response: Greater than or equal to 50% reduction in tumor size on volumetric MRI scan, on a stable/decreasing dose of glucocorticoids, with stable/improving neurologic examination for min 4 wks.
Progressive Disease: Progressive neurologic abnormalities not explained by causes unrelated to tumor progression (e.g. anticonvulsant or corticosteroid toxicity, electrolyte abnormalities, hyperglycemia, etc.) or a greater than 25% increase in the volume of the tumor by MRI scan. If neurologic status deteriorates, on stable/increasing dose of steroids, or if new lesions appear on serial MRI, further study treatment will be discontinued.
Stable Disease: A patient whose clinical status and MRI volumetrics do not meet the criteria for Complete Response, Partial Response or Progressive Disease."|3 years|no objective responses observed. 19 patients treated at the MTD from during Phase 2 and 4 patients treated at the MTD during the Phase 1 nonP450 arm 2 were included in the response analysis.||participants|||Number
853695|NCT00045708|Primary|Measure Pharmacokinetic Parameters Using Volume of Distribution at Steady State as Related to BMS-247550 and Anticonvulsants|Vss = volume of distribution at steady-state (how widely distributed in the body the drug gets)|Course 1, Day 1 (pre-infusion, midpoint of infusion, 5min prior to end of infusion, 15min, 30min, 1hr, 2hr, 3hr, 4hr and 6hr post infusion|13 of the 21 samples for P450 collected day 1 sample set and 16 of the 17 samples for the nonP40 collected day 1 sample set||l/m2||Standard Deviation|Mean
853696|NCT00045708|Primary|Measure Pharmacokinetic Parameters Using Clearance as Related to BMS-247550 and Anticonvulsant Measurements|CL = clearance (how much volume of blood is cleared of the drug per unIT of time|Course 1, Day 1 (pre-infusion, midpoint of infusion, 5min prior to end of infusion, 15min, 30min, 1hr, 2hr, 3hr, 4hr and 6hr post infusion|13 of the 21 samples for P450 collected day 1 sample set and 16 of the 17 samples for the nonP40 collected day 1 sample set||l/h/m2||Standard Deviation|Mean
853697|NCT00045708|Primary|Measure Pharmacokinetic Parameters Using Estimation of Half-lives Related to BMS-247550 and Anticonvulsants|T1/2,z = terminal half-life (T1/2) --- for a 2 or 3 compartment drug, idea of how long drugs stick around|Course 1, Day 1 (pre-infusion, midpoint of infusion, 5min prior to end of infusion, 15min, 30min, 1hr, 2hr, 3hr, 4hr and 6hr post infusion|13 of the 21 samples for P450 collected day 1 sample set and 16 of the 17 samples for the nonP40 collected day 1 sample set||h||Standard Deviation|Mean
853698|NCT00045708|Primary|Group A (P450) Estimated MTD and Group B (nonP450) Estimated MTD of BMS-247550 in Patients With Recurrent or Progressive Malignant Glioma|Starting dose for both Group A and Group B was 5mg/m2/day. A continuing reassessment method (CRM) was employed independently for each group to estimate the maximum tolerated dose. Only toxicity observed during 1st cycle of treatment (21 days) was used for dose finding. Dose limiting toxicity (DLT) defined as: ANC<500/ul, platelets<25,000, febrile neutropenia or treatment-related grade 3 or 4 non-hematologic toxicity with the exception of nausea and vomiting.|21 days (1 cycle)|||mg/m2/day|||Number
853699|NCT00045708|Primary|Number of Dose Limiting Toxicity to Determine Maximum Tolerated Dose (MTD) of BMS-247550 in Patients With Recurrent or Progressive Malignant Glioma|Starting dose for both Group A and Group B was 5mg/m2/day. A continuing reassessment method (CRM) was employed independently for each group to estimate the maximum tolerated dose. Only toxicity observed during 1st cycle of treatment (21 days) was used for dose finding. Dose limiting toxicity (DLT) defined as: ANC<500/ul, platelets<25,000, febrile neutropenia or treatment-related grade 3 or 4 non-hematologic toxicity with the exception of nausea and vomiting.|21 days (1 cycle)|4 subjects from Group B (Phase 1) were included in Group 3 (Phase 2). Only those on non-anticonvulsants at the dose of 6.8mg/m2/day were treated in Phase 2. No subjects treated at the MTD for P450, as the accrual goal for phase 2 reached before MTD for p450 was determined. P450 MTD determined as 9.6mg/m2 per CRM after all enrollment of phase 2||DLTs|||Number
853742|NCT02345226|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-defined Snapshot Algorithm|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Full Analysis Set: all participants who (1) were randomized into the study, (2) received at least 1 dose of study drug, and (3) were on EFV/FTC/TDF FDC prior to the screening visit||percentage of participants|||Number
853729|NCT02447848|Secondary|PI at Each Evaluation Time Point|Pain intensity at each evaluation time point after the first dose of study drug up through 5 hours is evaluated using an 11-point NRS where 0 equals no pain and 10 equals worst possible pain. The score was obtained at Baseline, 15- , 30-, 45- minutes, 1-hour, and 2-hours after the first dose for all patients, and at hours 3, 4, and 5 for cohort 2 (patients 41-76). Scores ranged from 0 -10 for the first two hours, and 2 - 10 for hours three to five.|5 hours|The first cohort of patients (N=40) received one dose of study drug and the study was completed at two hours. The second cohort of patients (N=36) had the option of remaining in the study through five hours; most patients discontinued the study at 2 hours.||units on a scale||Standard Error|Mean
853730|NCT02447848|Secondary|TOTPAR1 (Time-weighted)|"The total pain relief (TOTPAR) is the time-weighted sum of the pain relief scores over the first hour (15 minutes, 30 minutes, 45 minutes and 1-hour after the first dose of study drug is taken) of the study period.
The minimum score is 0.00 and the maximum score is 4.00. A higher score indicates greater pain relief."|1-hour|||units on a scale||Standard Error|Mean
853731|NCT02447848|Primary|Time-weighted Summed Pain Intensity Difference (SPID) Over the 1-hour (SPID1).|"The primary efficacy endpoint is the time-weighted SPID1 evaluated from the patient questionnaire data. Pain intensity (PI) will be measured using an 11-point numerical rating scale (NRS) with 0 (no pain) and 10 (worst possible pain).
The patient’s rating of PI will be measured at baseline and at 0.25 (15 min), 0.5 (30 min), 0.75 (45 min), 1, 2, 3, 4, and 5 hours following the first dose of study drug.
The PID at each evaluation time point after the initiation of the first dose is the difference in PI at the specific evaluation time point and baseline pain intensity [PID (evaluation time after the first dose) = PI(baseline) – PI(evaluation time after the first dose)]. The time-weighted SPID1 is the time-weighted summed PID over the 1-hour study period.
The observed SPID scores ranged from -.70 to 8.00. A negative score indicates an increase in pain intensity and a positive score indicates a decrease in pain intensity."|One hour|||units on a scale||Standard Error|Mean
853736|NCT02345226|Secondary|Change From Baseline in HIV Symptoms Index Score (HIVSI)|The HIV Symptoms Index was a 20-item, self-reported measure that addressed presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. Twenty HIV symptoms including Fatigue, Fever, Dizziness, Hand/Foot Pain, Memory Loss, Nausea, Diarrhea, Sadness, Nervous/anxious, Sleep Trouble, Skin Problems, Cough, Headache, Appetite Loss, Stomach Pain, Muscle/Joint Pain, Sex Problems, Change in Fat Deposits, Weight Loss, and Hair Loss were assessed. There were 5 possible responses (0 = I don’t have this symptom; 1 = It doesn’t bother me; 2 = It bothers me a little; 3 = It bothers me; and 4 = It bothers me a lot) for each HIV symptom. Total HIV Symptoms Index Score was derived from all 20 HIV symptoms by counting the number of bothersome symptoms. Total score would be missing if any of the individual items were missing.|Week 48; Week 96|"Participants in the Safety Analysis Set with available data were analyzed.
The data presented are for the Week 48 analysis."||units on a scale||Standard Deviation|Mean
853737|NCT02345226|Secondary|Percent Change From Baseline in Spine Bone Mineral Density (BMD)|Spine BMD was assessed by dual energy x-ray absorptiometry (DXA) scan.|Week 48; Week 96|"Participants in the Spine DXA Analysis Set (all randomized participants, received at least 1 dose of study drug, and had nonmissing baseline spine BMD values) with available data were analyzed.
The data presented are for the Week 48 analysis."||percentage change in spine BMD||Standard Deviation|Mean
853738|NCT02345226|Secondary|Percent Change From Baseline in Hip Bone Mineral Density (BMD)|Hip BMD was assessed by dual energy x-ray absorptiometry (DXA) scan.|Week 48; Week 96|"Participants in the Hip DXA Analysis Set (all randomized participants received at least 1 dose of study drug, and had nonmissing baseline hip BMD value) with available data were analyzed.
The data presented are for the Week 48 analysis."||percentage change in hip BMD||Standard Deviation|Mean
853739|NCT02345226|Secondary|Change From Baseline in CD4+ Cell Count||Week 48; Week 96|"Participants in the Full Analysis Set with on-treatment data were analyzed.
The data presented are for the Week 48 analysis."||cells/uL||Standard Deviation|Mean
853740|NCT02345226|Secondary|Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-defined Snapshot Algorithm||Week 96||||||
853741|NCT02345226|Secondary|Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Weeks 48 and 96 as Defined by the US FDA-defined Snapshot Algorithm||Week 48; Week 96|"Full Analysis Set: all participants who (1) were randomized into the study, (2) received at least 1 dose of study drug, and (3) were on EFV/FTC/TDF FDC prior to the screening visit
The data presented are for the Week 48 analysis."||percentage of participants|||Number
853757|NCT02301364|Secondary|Overall Response Rate|This study will use the Macdonald criteria. Specific lesions must be evaluated serially, and comparative analysis of changes in the area of contrast enhancement, as well as the non-enhancing component, should be performed. Complete Response: Complete disappearance of all measurable and non-measurable disease. No new lesions. Partial Response: Great than or equal to 50% decrease over the baseline in the sum of products of perpendicular diameters of all measurable lesions. no progression of non-measurable disease. No new lesions. Stable/No Response: Does not qualify for CT, PR, or progression. Progressive Disease: 25% increase in the sum of products of all measureable lesions over smallest sum observes (or baseline if no decrease), OR clear clinical worsening of any non-measurable disease, OR appearance of any new lesion/site, OR clear clinical worsening or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).|2 years|||Participants|||Count of Participants
853758|NCT02301364|Secondary|Overall Survival|Overall survival time is defined as the time from treatment start to the date of death due to any cause.|2 years|||days||Full Range|Median
853759|NCT02301364|Secondary|Number of Participants With Adverse Events|Adverse events be summarized based on the Common Toxicity Criteria version 4.0.|2 years|||Participants|||Count of Participants
853760|NCT02301364|Primary|Progression Free Survival|Progression-free survival (PFS) is defined as the time from the date of treatment start to the date of the first documented PD or death due to any cause. PFS will be based on the investigator’s assessment of MRI, CSF studies and clinical presentation.|2 years|||days||Full Range|Median
853761|NCT02287025|Secondary|Satisfaction of Investigator/Nurse With Enhanced Drug-specific Information Via SMART Questionnaire|Investigator comfort of managing adverse events, adjusting dosing schedule, and satisfaction with SMART application measured by a questionnaire; 10 categories were answered on a 1 - 7 scale.|Up to 1 year|The study was pre-maturely terminated. No data were collected from participants for this assessment.|||||
853762|NCT02287025|Secondary|Investigator Comfort With the Use of Regorafenib and Management of AEs as Measured by Questionnaire|Investigator comfort of managing adverse events, adjusting dosing schedule, and satisfaction with SMART application measured by a questionnaire; 10 categories were answered on a 1 - 7 scale.|Up to 1 year|The study was pre-maturely terminated. No data were collected from participants for this assessment.|||||
853763|NCT02287025|Secondary|Incidence of Grade 3 Hand-foot-skin Reaction (HFSR), Fatigue, Diarrhea, Hypertension|Documented during visits as part of the interval history. All AEs will be reported in the CRF with a diagnosis, start/stop dates, action taken.|Up to 1 year|The study was pre-maturely terminated. No data were collected from participants for this assessment.|||||
853764|NCT02287025|Secondary|Dose Intensity as Percentage of Planned Dose|Dose level 0 (standard starting dose) @ 160mg po qd. Dose level - 1 @ 120 mg po qd. Dose level - 2 @ 80 mg po qd. This schedule reflects the FDA-approved dosing specified in the prescribing information.|Up to 1 year|The study was pre-maturely terminated. No data were collected from participants for this assessment.|||||
853765|NCT02287025|Secondary|Duration of Treatment||Up to 1 year|The study was pre-maturely terminated. No data were collected from participants for this assessment.|||||
854924|NCT00907218|Secondary|Exhaled CO Levels|At baseline and all weekly study visits,exhaled carbon monoxide (CO) levels were read.|Weekly over 7 weeks|Data was not collected due to study termination, 2 subjects were recruited however their data was not analyzed|||||
853785|NCT02281773|Secondary|Change in Psychopathology Symptoms as Assessed by Positive and Negative Syndrome Scale (PANSS)|Change in psychopathology symptoms as assessed by Positive and Negative Syndrome Scale (PANSS). It contains 30-items including seven positive symptom items, seven negative symptom items and 16 general psychopathology symptom items. Each item was scored on the same seven point severity scale. Fourteen of the PANSS items required input from an informant. Total score ranges from 30 to 210 (minimum is better). The descriptive statistics of change from baseline (CFB) in PANSS score at week 6 (W6) and week 12 (W12) are presented.|Baseline, Week 6 and Week 12|TS||Unit on Scale||Standard Deviation|Mean
853786|NCT02281773|Secondary|Change From Baseline in PANSS Negative Symptom Factor Score After 12 Weeks of Treatment (for Subset of Patients Diagnosed With Negative Symptom)|Change from baseline in PANSS negative symptom factor score after 12 weeks of treatment (for subset of patients diagnosed with negative symptom). This outcome measure was not analysed due to low number of patients in the PANSS negative symptom subgroup. The PANSS negative symptom scale has 7 items. Each was rated from one to 7 points. The total factor score was the summation of the 7 points for each item, leading the total score ranging from 7 to 49.|Baseline and Week 12|This endpoint was not analysed because as per internal Boehringer Ingelheim rules, descriptive statistics are not calculated if data is available for less than 2/3rds of participants.|||||
853787|NCT02281773|Secondary|Patient Global Impressions-Improvement (PGI-I) Scale Score Measured After 12 Weeks of Treatment|Patient Global Impressions-Improvement (PGI-I) scale score measured after 12 weeks of treatment. The PGI of improvement is a simple evaluation completed by the patient to assess the patient’s overall evaluation of his/her status. The PGI of improvement was rated ordinally from one to 7. Higher scores indicate more severe symptoms.|Up to 12 weeks|FAS||Unit on Scale||Standard Deviation|Mean
853788|NCT02281773|Secondary|Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Scale Score After 12 Weeks of Treatment|Change from baseline in Clinical Global Impressions-Severity (CGI-S) scale score after 12 weeks of treatment. The CGI-S is a one-item evaluation completed by the clinician on the patient’s severity of psychopathology. The CGI-S was rated ordinally from one to 7. Higher scores indicate more severe symptoms.|Baseline and Week 12|The full analysis set (FAS) was to consist of all randomisation patients who were treated with at least one dose of study drug and had a baseline and at least one post baseline on treatment primary endpoint MCCB composite score.||Unit on Scale||Standard Error|Least Squares Mean
853789|NCT02281773|Secondary|Change From Baseline in Everyday Functional Capacity as Measured by Schizophrenia Cognition Rating Scale (SCoRS) Global Ratings After 12 Weeks of Treatment|Change from baseline in everyday functional capacity as measured by Schizophrenia Cognition Rating Scale (SCoRS) global ratings after 12 weeks of treatment. SCoRS is a 20-item interview-based assessment of cognitive deficits and the degree to which they affect day-to-day functions. Each item was rated on a 4-point scale. Higher ratings reflected a greater degree of impairment. The SCoRS global total scores is the sum of the 20 items and it varies from 20 to 80 with 20 being the best outcome and 80 being the worst. If any individual item was missing, it was imputed with the average of that patient's non missing responses. If >5 items were missing, the total score was missing.|Baseline and Week 12|The full analysis set (FAS) was to consist of all randomisation patients who were treated with at least one dose of study drug and had a baseline and at least one post baseline on treatment primary endpoint MCCB composite score.||Unit on Scale||Standard Error|Least Squares Mean
853790|NCT02281773|Primary|Suicidality as Assessed by Columbia Suicidal Severity Rating Scale (C-SSRS)|"C-SSRS: Number (%) of subjects with an event of Suicidal Ideation (Wish to be dead, Non−specific active suicidal thoughts, Active suicidal ideation with any methods (not plan) without intent to act, Active suicidal ideation with some intent to act without specific plan, Active suicidal ideation with specific plan and intent) or Suicidal Behavior (Preparatory acts or behavior, Aborted attempt, Interrupted attempt, Non−fatal suicide attempt, Completed suicide) or Self−injurious behavior without suicidal intent is presented. C-SSRS used only to evaluate whether the patient developed suicidal ideation or behavior and no composite score will be used. Questions in the 1st section of suicidal ideation and suicidal behavior assessments in C-SSRS are yes and no type questions. If patient had suicidal ideation or behavior, 2nd section will be performed to evaluate the details with the scale from 0 to 5 or 0 to 2 and the larger number means the more severe condition."|Up to 12 weeks|TS (Number of subjects with a post baseline C−SSRS)||Percentage of Participants|||Number
853791|NCT02281773|Primary|Dramatic Worsening of Disease State as Assessed by Positive and Negative Syndrome Scale (PANSS)|Dramatic worsening of disease state as assessed by Positive and Negative Syndrome Scale (PANSS). It contains 30-items including seven positive symptom items, seven negative symptom items and 16 general psychopathology symptom items. Each item was scored on the same seven point severity scale. Fourteen of the PANSS items required input from an informant. Total score ranges from 30 to 210 (minimum is better). The descriptive statistics of change from baseline (CFB) in PANSS score at week 6 (W6) and week 12 (W12) are presented.|Baseline, Week 6 and Week 12|TS||Unit on Scale||Standard Deviation|Mean
853792|NCT02281773|Primary|Occurrence of Protocol-specified Adverse Events of Special Interest (AESI)|Occurrence of Protocol-specified adverse events of special interest (AESI).|Up to 20 weeks|The treated set (TS) was to consist of all patients who were randomised and treated with at least one dose of study drug.||Percentage of Participants|||Number
853793|NCT02281773|Primary|Occurrence of Serious Adverse Events (SAEs) (Including the Abnormalities of Physical Examination, Vital Signs, Electrocardiogram (ECG) Test and Laboratory Tests)|Occurrence of serious adverse events (SAEs) (including the abnormalities of physical examination, vital signs, electrocardiogram (ECG) test and laboratory tests).|Up to 20 weeks|The treated set (TS) was to consist of all patients who were randomised and treated with at least one dose of study drug.||Percentage of Participants|||Number
853794|NCT02281773|Primary|Change From Baseline in the Composite Score of Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) After 12 Weeks of Treatment|MCCB comprises 10 tests, which assess 7 cognitive domains, including speed of processing, attention vigilance, working memory, verbal learning, visual learning, reasoning problem solving, and social cognition. The composite score was calculated by summing over the standardised score of each domain for analysis and it varies from -20 to 99 with higher score indicating better outcome. The trial was set up as “learn and confirm” model including 2 stages. Stage 1 analysis was conducted to identify the meaningful cognition endpoint(s) (CANTAB domain(s)) and the selected endpoint(s) were to be pre-specified as the primary endpoint(s) for Stage 2 analysis. Since none of the CANTAB outcome measures was selected in the Stage 1 analysis at planned time based on the pre-specified criteria, the MCCB composite score was chosen as the primary endpoint in the Stage 2 analysis, as pre-defined.|Baseline and Week 12|The full analysis set (FAS) was to consist of all randomisation patients who were treated with at least one dose of study drug and had a baseline and at least one post baseline on treatment primary endpoint MCCB composite score.||Unit on Scale||Standard Error|Least Squares Mean
853811|NCT02249065|Secondary|Inflammatory Lesions|Change from baseline in facial inflammatory lesion count|14 days|ITT Population, Subjects who received at least 1 application of study drug, and completed at least 1 assessment||lesions||Standard Deviation|Mean
853812|NCT02249065|Secondary|Facial Redness Visual Analog Scale (VAS)|The number and percent of subjects in each transformed response category for the in-office subject reported facial redness VAS|14 days|ITT Population, Subjects who received at least 1 application of study drug, and completed at least 1 assessment||Participants|||Count of Participants
853813|NCT02249065|Secondary|Subject Treatment Satisfaction Questionnaire|Mean Subject Treatment Satisfaction at Day 14 (Average Response Across 12 Questions)|14 days|ITT Population, Subjects who received at least 1 application of study drug, and completed at least 1 assessment||Participants||Standard Deviation|Mean
853814|NCT02249065|Secondary|Subject Facial Redness Questionnaire|Facial Redness Questionnaire at Day 1 and Day 14 (Mean Number of Subjects Who's Responses Indicate They Were/Were Not Bothered By Facial Redness, Across All 11 Facial Redness Questions)|14 days|ITT Population, Subjects who received at least 1 application of study drug, and completed at least 1 assessment||Participants||Standard Deviation|Mean
853815|NCT02249065|Primary|Pre-Treatment Clinician Erythema Assessment (CEA)|The number and percent of subjects in each CEA score category at each visit. CEA was conducted at the screening/baseline visit and all subsequent visits prior to the study drug application.|14 days|Intent-to-treat (ITT) Population; Subjects who received at least 1 application of study drug, and completed at least 1 assessment||Participants|||Count of Participants
853840|NCT02207231|Secondary|Percentage of Participants Who Achieved a Psoriasis Symptom and Sign Diary (PSSD) Symptom Score of 0 in the Guselkumab Group Compared to the Adalimumab Group at Week 24|The PSSD (24-hour version) is a patient-reported outcome (PRO) questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items (>=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that Symptom [or Sign] score = average value*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease.|Week 24|PSSD analysis set included all those participants who were randomized at Week 0 and had baseline PSSD score greater than 0.||percentage of participants|||Number
853841|NCT02207231|Secondary|Change From Baseline in Psoriasis Symptom and Sign Diary (PSSD) Symptom Score at Week 16 in the Guselkumab Group Compared to the Placebo Group|The PSSD (24-hour version) is a patient-reported outcome (PRO) questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items (>=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that Symptom [or Sign] score = average value*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease. This secondary outcome measure was planned to include only the placebo and guselkumab arms.|Baseline and Week 16|PSSD analysis set included all those participants who had baseline PSSD scores as the average score of at least 4 days out of the 7 days prior to the Week 0 visit.||units on a scale||Standard Deviation|Mean
853842|NCT02207231|Secondary|Percentage of Participants Who Achieved a Scalp-specific Investigator's Global Assessment (Ss-IGA) Score of 0 or 1 and at Least a 2-Grade Improvement From Baseline at Week 16 in the Guselkumab Group Compared to the Placebo Group|The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. The lesions were assessed in terms of the clinical signs of redness, thickness, and scaliness, which are scored on a 5-point scale ranging from 0 = absence of disease, 1 = very mild disease, 2 = mild disease, 3 = moderate disease, and 4 = severe disease. This secondary outcome measure was planned to include only the placebo and guselkumab arms.|Week 16|Population analyzed included only randomized participants at Week 0 who had an ss-IGA score greater than or equal to (>=) 2 at baseline.||percentage of participants|||Number
853843|NCT02207231|Secondary|Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response in the Guselkumab Group Compared to the Adalimumab Group at Week 16|The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 percent improvement from baseline in the PASI score.|Week 16|Randomized analysis set include all participants randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 16 or who did not come for evaluation at week 16 were considered nonresponders) was used to impute missing values.||percentage of participants|||Number
853844|NCT02207231|Secondary|Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Adalimumab Group at Week 16|The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.|Week 16|Randomized analysis set include all participants randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 16 or who did not come for evaluation at week 16 were considered nonresponders) was used to impute missing values.||percentage of participants|||Number
853845|NCT02207231|Secondary|Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Adalimumab Group at Week 16|The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants’ psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).|Week 16|Randomized analysis set include all participants randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 16 or who did not come for evaluation at week 16 were considered nonresponders) was used to impute missing values.||percentage of participants|||Number
853846|NCT02207231|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16 in the Guselkumab Group Compared to the Placebo Group|The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants. This secondary outcome measure was planned to include only the placebo and guselkumab arms.|Baseline, Week 16|Randomized analysis set included all participants who were randomized at Week 0 and have a baseline DLQI score.||units on a scale||Standard Deviation|Mean
853847|NCT02207231|Secondary|Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Adalimumab Group at Week 24 and 48|The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.|Week 24 and 48|Randomized analysis set included all participants randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 24 or Week 48 or who did not come for evaluation at Week 24 or Week 48 were considered nonresponders, respectively, for Week 24 or Week 48 outcome measures) was used to impute missing values.||percentage of participants|||Number
853848|NCT02207231|Secondary|Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Adalimumab Group at Week 24 and 48|The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants’ psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).|Week 24 and 48|Randomized analysis set included all participants randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 24 or Week 48 or who did not come for evaluation at Week 24 or Week 48 were considered nonresponders, respectively, for Week 24 or Week 48 outcome measures) was used to impute missing values.||percentage of participants|||Number
853849|NCT02207231|Secondary|Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) in the Guselkumab Group Compared to the Adalimumab Group at Week 24 and 48|The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants’ psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).|Week 24 and 48|Randomized analysis set included all participants randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 24 or Week 48 or who did not come for evaluation at Week 24 or Week 48 were considered nonresponders, respectively, for Week 24 or Week 48 outcome measures) was used to impute missing values.||percentage of participants|||Number
853850|NCT02207231|Primary|Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Placebo Group at Week 16|The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.|Week 16|Randomized analysis set include all participants randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 16 or who did not come for evaluation at week 16 were considered nonresponders) was used to impute missing values.||percentage of participants|||Number
853851|NCT02207231|Primary|Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Placebo Group at Week 16|The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants’ psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).|Week 16|Randomized analysis set include all participants randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 16 or who did not come for evaluation at week 16 were considered nonresponders) was used to impute missing values.||percentage of participants|||Number
853873|NCT02132468|Secondary|Objective Response Rate|ORR is per investigator assessment of RECIST 1.1 criteria|4 months|||Participants|||Count of Participants
853874|NCT02132468|Primary|Change From Baseline Serotonin Biomarker Levels|Mean change from baseline in biomarker level with a 25% reduction = improved and a 25% increase = worsened;|4 months|||Participants|||Count of Participants
853875|NCT02132468|Primary|Change From Baseline 5-HIAA Biomarker Levels|Mean change from baseline in biomarker level with a 25% reduction = improved and a 25% increase = worsened;|4 months|||Participants|||Count of Participants
853876|NCT02132468|Primary|Change From Baseline CgA Biomarker Levels|Mean change from baseline in biomarker level with a 25% reduction = improved and a 25% increase = worsened;|4 months|||Participants|||Count of Participants
853922|NCT02096081|Secondary|Subject Perception of Treatment Peak Effect|Assessment of subject perception of date of treatment peak effect using a take-home diary|Open-ended time frame for the 4 month study duration. Data for onset and peak effect is recorded in the subject diary.|This endpoint was analyzed using observed cases in the per protocol set (PPS), defined as the subset of subjects in the FAS from whom no major protocol deviations were identified.||participants|||Number
853923|NCT02096081|Secondary|Subject Perception of Treatment Onset|Assessment of subject perception of date of treatment onset using a take-home diary|Open-ended time frame for the 4 month study duration. Data for onset and peak effect is recorded in the subject diary.|This endpoint was analyzed using observed cases in the per protocol set (PPS), defined as the subset of subjects in the FAS from whom no major protocol deviations were identified.||days||Full Range|Median
853924|NCT02096081|Secondary|Subject Satisfaction|"Assessment of subject treatment satisfaction by subject questionnaire and diary at 4 months from treatment. Extremely satisfied, satisfied, and slightly satisfied were categorized as Satisfaction and extremely dissatisfied, dissatisfied, and slightly dissatisfied were categorized as Dissatisfaction. Subjects with missing data were categorized as Missing."|4 months from baseline|This endpoint was analyzed using observed cases in the per protocol set (PPS), defined as the subset of subjects in the FAS from whom no major protocol deviations were identified.||participants|||Number
853925|NCT02096081|Secondary|Subject Satisfaction|"Assessment of subject treatment satisfaction by subject questionnaire and diary at 3 months from treatment. Extremely satisfied, satisfied, and slightly satisfied were categorized as Satisfaction and extremely dissatisfied, dissatisfied, and slightly dissatisfied were categorized as Dissatisfaction. Subjects with missing data were categorized as Missing."|3 months from baseline|This endpoint was analyzed using observed cases in the per protocol set (PPS), defined as the subset of subjects in the FAS from whom no major protocol deviations were identified.||participants|||Number
853926|NCT02096081|Secondary|Subject Satisfaction|"Assessment of subject treatment satisfaction by subject questionnaire and diary at 2 months from treatment. Extremely satisfied, satisfied, and slightly satisfied were categorized as Satisfaction and extremely dissatisfied, dissatisfied, and slightly dissatisfied were categorized as Dissatisfaction. Subjects with missing data were categorized as Missing."|2 months from baseline|This endpoint was analyzed using observed cases in the per protocol set (PPS), defined as the subset of subjects in the FAS from whom no major protocol deviations were identified.||participants|||Number
853927|NCT02096081|Secondary|Subject Satisfaction|"Assessment of subject treatment satisfaction by subject questionnaire and diary at 1 month from treatment. Extremely satisfied, satisfied, and slightly satisfied were categorized as Satisfaction and extremely dissatisfied, dissatisfied, and slightly dissatisfied were categorized as Dissatisfaction. Subjects with missing data were categorized as Missing."|1 month from baseline|This endpoint was analyzed using observed cases in the per protocol set (PPS), defined as the subset of subjects in the FAS from whom no major protocol deviations were identified.||participants|||Number
853928|NCT02096081|Secondary|Response at Maximum Frown Rated by Treating Physician|Response defined as ≥ 1 point improvement from baseline on the Facial Wrinkle Scale (0=None to 3=severe) at maximum frown as rated by the treating physicians using subject photographs at 4 months from treatment.|4 months from baseline|All efficacy analyses were performed on the per protocol set (PPS) defined as the subset of subjects in the FAS for whom no major protocol deviations were identified.||percentage of participants|||Number
853929|NCT02096081|Secondary|Response at Maximum Frown Rated by Treating Physician|Response defined as ≥ 1 point improvement from baseline on the Facial Wrinkle Scale (0=None to 3=severe) at maximum frown as rated by the treating physicians using subject photographs at 3 months from treatment.|3 months from baseline|All efficacy analyses were performed on the per protocol set (PPS) defined as the subset of subjects in the FAS for whom no major protocol deviations were identified.||percentage of participants|||Number
853930|NCT02096081|Secondary|Response at Maximum Frown Rated by Treating Physician|Response defined as ≥ 1 point improvement from baseline on the Facial Wrinkle Scale (0=None to 3=severe) at maximum frown as rated by the treating physicians using subject photographs at 2 months from treatment.|2 months from baseline|All efficacy analyses were performed on the per protocol set (PPS) defined as the subset of subjects in the FAS for whom no major protocol deviations were identified.||percentage of participants|||Number
853931|NCT02096081|Secondary|Response at Maximum Frown Rated by Treating Physician|Response defined as ≥ 1 point improvement from baseline on the Facial Wrinkle Scale (0=None to 3=severe) at maximum frown as rated by the treating physicians using subject photographs at 1 month from treatment.|1 month from baseline|All efficacy analyses were performed on the per protocol set (PPS) defined as the subset of subjects in the FAS for whom no major protocol deviations were identified.||percentage of participants|||Number
853932|NCT02096081|Secondary|Response at Maximum Frown Rated by Independent Rater|Response defined as ≥ 1 point improvement from baseline on the Facial Wrinkle Scale (0=None to 3=severe) at maximum frown as rated by an independent masked panel of physicians specifically qualified to assess study photographs using subject photographs at 4 months from baseline.|4 months from baseline|All efficacy analyses were performed on the per protocol set (PPS) defined as the subset of subjects in the FAS for whom no major protocol deviations were identified.||percentage of participants|||Number
853933|NCT02096081|Secondary|Response at Maximum Frown Rated by Independent Rater|Response defined as ≥ 1 point improvement from baseline on the Facial Wrinkle Scale (0=None to 3=severe) at maximum frown as rated by an independent masked panel of physicians specifically qualified to assess study photographs using subject photographs at 3 months from baseline.|3 months from baseline|All efficacy analyses were performed on the per protocol set (PPS) defined as the subset of subjects in the FAS for whom no major protocol deviations were identified.||percentage of participants|||Number
853934|NCT02096081|Secondary|Response at Maximum Frown Rated by Independent Rater|Response defined as ≥ 1 point improvement from baseline on the Facial Wrinkle Scale (0=None to 3=severe) at maximum frown as rated by an independent masked panel of physicians specifically qualified to assess study photographs using subject photographs at 2 months from baseline.|2 months from baseline|All efficacy analyses were performed on the per protocol set (PPS) defined as the subset of subjects in the FAS for whom no major protocol deviations were identified.||percentage of participants|||Number
853935|NCT02096081|Primary|Efficacy, Measured as the Percentage of Participants Who Responded to Treatment|Response defined as ≥ 1 point improvement from baseline (prior to treatment) on the Facial Wrinkle Scale at maximum frown as rated by an independent masked panel of physicians specifically qualified to assess study photographs using subject photographs at 1 month from treatment.|1 Month from baseline|All efficacy analyses were performed on the per protocol set (PPS) defined as the subset of subjects in the FAS for whom no major protocol deviations were identified.||percentage of participants|||Number
853966|NCT02023983|Secondary|Complications Associated With the Puncture Site Requiring Treatment in 30 Days After Myocardial Infarction (MI)|Fischer´s exact test was used for comparison of qualitative variables between two groups. For comparison of quantitative variables we applied Mann-Whitney U test, respectively Student´s t-test (age). Normality of data was assessed with Shapiro-Wilk test. Values of p < 0.05 were considered as statistically significant.|30 days|||Participants|||Count of Participants
853967|NCT02023983|Primary|Composite of Incidence of Death, Reinfarction, Unstable Angina Pectoris, Stroke, Unplanned Rehospitalization, Repeat Target Vessel Revascularization and Stent Thrombosis in 90 Days After Myocardial Infarction (MI)|Fischer´s exact test was used for comparison of qualitative variables between two groups. For comparison of quantitative variables we applied Mann-Whitney U test, respectively Student´s t-test (age). Normality of data was assessed with Shapiro-Wilk test. Values of p < 0.05 were considered as statistically significant.|90 days|||Participants|||Count of Participants
853968|NCT02001714|Secondary|Group Behavioral Treatment Cost-effectiveness|Measure resource use and utilities and compare the difference in incontinence management costs and utilities between treatment and control group.|12 months||||||
853969|NCT02001714|Primary|Group Behavioral Treatment Effectiveness as Shown by Changes From Baseline to 3 Months in Urinary Incontinence Severity.|The primary outcome is the self-reported urinary incontinence severity as measured by the International Consultation on Incontinence questionnaire-short form (ICI-Q). This short and simple questionnaire is used to screen for incontinence (urine leakage) to obtain a brief yet comprehensive summary of the level, impact and perceived cause of symptoms of incontinence. The ICI-Q consists of four questions and numeric scales: 1. How much do you leak urine? (0-5); never - all the time, 2. How much urine do you usually leak? (0-6); none - large amount, 3. Overall, how much does leaking urine interfere with your everyday life? (0-10); not at all - a great deal, 4. When does urine leak? Multiple choices. The ICI-Q score is the sum of questions 1-3 and ranges from 0-21. The higher the score, the greater severity of incontinence. Baseline data is compared to the 3 month data for the primary outcome.|Baseline and 3 months|The Group Behavioral Treatment group population at baseline is 232. At the 3 month follow-up visit 16 had withdrawn and 7 missed the appointment, leaving 209 for the total number analyzed. For the No Treatment group, the number at baseline is 231 and by the 3 month visit 8 had withdrawn and another 11 missed the appointment, leaving 212.||units on a scale||Inter-Quartile Range|Median
854009|NCT01966003|Secondary|Overall Survival|"Overall survival (OS) was defined as the time from the randomization date to date of death. Participants alive at the end of study were censored at the last date known to be alive, derived from dates collected within the study that implied a participant was alive.
Participants were followed for survival status during the treatment phase and thereafter every 9 weeks until the end of the clinical study, consent was withdrawn, they were lost to follow-up, died, or had proscribed therapy (eg, commercial bevacizumab, non-study anti-cancer treatment)."|From randomization until the end of study; The mean actual follow-up time from randomization was 4.7 and 5.0 months for ABP 215 and bevacizumab, respectively.|Safety analysis population||months||95% Confidence Interval|Median
854010|NCT01966003|Secondary|Number of Participants Who Developed Anti-drug Antibodies|Two validated assays were used to detect the presence of anti-ABP 215 antibodies. Samples were first tested in an electrochemiluminescence (ECL)- based bridging immunoassay to detect antibodies capable of binding to ABP 215 (Binding Antibody Assay). Samples confirmed to be positive for binding antibodies were subsequently tested in a non-cell based target binding assay to determine neutralizing activity against ABP 215 (Neutralizing Antibody Assay). If a post-dose sample was positive for binding antibodies and demonstrated neutralizing activity at the same time point, the sample was defined as positive for neutralizing antibodies.|44 weeks (6 months after end of treatment)|Safety analysis population with available data||participants|||Number
854011|NCT01966003|Secondary|Number of Participants With Adverse Events|"Adverse events (AEs) were graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4, and according to the following scale: Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death due to AE.
A serious adverse event (SAE) is defined as an AE that meets at least 1 of the following serious criteria:
fatal
life-threatening
required inpatient hospitalization or prolongation of existing hospitalization
resulted in persistent or significant disability/incapacity
congenital anomaly/birth defect
other medically important serious event"|up to 19 weeks|Safety analysis population consisted of all participants who received any amount of study drug.||participants|||Number
854012|NCT01966003|Secondary|Progression-free Survival|"Progression-free survival (PFS) was defined as the time from the randomization date to the date of disease progression using RECIST v1.1 based on the central, independent, blinded radiologists’ review, or death. Participants who were alive and did not meet the criteria for progression by the end of the study were censored at their last evaluable disease assessment date. Participants with no evaluable tumor assessments after randomization who did not die by the end of the study were censored on the randomization date.
Progressive Disease was defined as at least a 20% increase in the sum of diameters of target lesions with an absolute increase of at least 5 mm, or, unequivocal progression of existing non-target lesions, or any new lesions."|From randomization until the end of study; The mean actual follow-up time from randomization was 4.7 and 5.0 months for ABP 215 and bevacizumab, respectively.|Intent-to-treat population||months||95% Confidence Interval|Median
854013|NCT01966003|Secondary|Duration of Response|"Duration of response (DOR) was calculated as the time from the first objective response (PR or CR) to disease progression per RECIST v1.1 based on the central, independent, blinded radiologists’ review.
DOR was only calculated for participants with an objective response. For responders not meeting the criterion for progression by the end of the study, DOR was censored at the date of the last evaluable tumor assessment.
Progressive Disease was defined as at least a 20% increase in the sum of diameters of target lesions with an absolute increase of at least 5 mm, or, unequivocal progression of existing non-target lesions, or any new lesions."|Disease assessments were performed at weeks 1, 7, 13, 19, and approximately every 9 weeks thereafter. The mean actual follow-up time from randomization was 4.7 and 5.0 months for ABP 215 and bevacizumab, respectively.|Intent-to-treat population with an objective response||months||95% Confidence Interval|Median
854026|NCT01832090|Secondary|Global Aesthetic Improvement Scale (GAIS) Ratings, by Subject, Among All Treated Subjects With and Without Retreatment|To evaluate the efficacy of Radiesse for hand treatment as measured by live, subject-completed Global Aesthetic Improvement Scale (GAIS) scores between baseline and 3, 6, 9, and 12 months, by subject, among treated subjects with and without retreatment|3, 6, 9, and 12 months from baseline|Single withdrawn subject did not receive treatment and is not included in this analysis.||percentage of participants|Hands||Number
854174|NCT01503164|Secondary|Glucose Effectiveness (SG)|Glucose effectiveness is the ability for glucose to move intracellularly in the absence of insulin. It is a parameter that results from the MINMOD analysis of the serum glucose and insulin levels derived from the frequently sampled intravenous glucose tolerance test. Low SG indicates a lower predisposition for glucose disposal independent of any effects of insulin.|Baseline|55 randomized to PAP (2 dropout); 56 randomized to lifestyle (1 dropout)||[min]^-1||Standard Deviation|Mean
854014|NCT01966003|Primary|Percentage of Participants With an Objective Response|"Tumor assessments were performed by central, independent, blinded radiologists according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 using computed tomography (CT) or magnetic resonance imaging (MRI) scans of the chest and abdomen. Objective response is defined as a best overall response of partial response (PR) or complete response (CR) as defined by RECIST v1.1. All participants who did not meet the criteria for CR or PR by the end of the study were considered non-responders.
CR: Disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes must be reduced in short axis to < 10 mm.
PR: Disappearance of all target lesions with persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits, and no new lesions, or, at least a 30% decrease in the sum of diameters of target lesions, with no progression of existing non-target lesions and no new lesions."|Disease assessments were performed at weeks 1, 7, 13, 19, and approximately every 9 weeks thereafter. The mean actual follow-up time from randomization was 4.7 and 5.0 months for ABP 215 and bevacizumab, respectively.|Intent-to-treat population which consisted of all randomized participants.||percentage of participants|||Number
854015|NCT01946529|Secondary|Local Failure Rate|Loco-regional failure is defined as the time interval from date of start of local therapy to date of loco-regional failure. Distant failure or death prior to loco-regional failure will be considered competing events in the analyses. The cumulative incidence of loco-regional failure will be estimated using methods described in Kalbfleisch and Prentice.|Maximum of 11 years after the start of therapy||||||
854016|NCT01946529|Secondary|Time to Progression|Median time to progression of group B patients will be estimated from the Kaplan-Meier curve.|Maximum of 11 years after the start of therapy||||||
854017|NCT01946529|Secondary|Progression-free Survival|Progression free survival (PFS) is defined as the time interval from the date on study to the date of disease progression or death or the date if last follow-up. PFS will be estimated using the method of Kaplan-Meier for group A and B participants, respectively.|Maximum of 11 years after the start of therapy||||||
854018|NCT01946529|Secondary|Overall Survival|Overall survival (OS) is defined as the time interval from the date on study to the date of death or the date of last follow-up. OS will be estimated using the method of Kaplan-Meier for group A and B participants, respectively.|Maximum of 11 years after the start of therapy||||||
854019|NCT01946529|Primary|Response to Window Therapy (2 Courses) for Group B (High-risk) - ESFT Participants|Response rate will be defined as the proportion of patients who achieved complete response or partial response (CR+PR) using the World Health Organization (WHO) criteria evaluated after two initial courses of temsirolimus, temozolomide and irinotecan in previously untreated patients with high risk Ewing Sarcoma Family of Tumor (ESFT). Participants who are treated in Group B with Desmoplastic Small Round Cell Tumor (DSRCT) or those who do not receive window therapy will not be included in this analysis.|at 6 weeks after start of therapy (after 2 initial courses)|Of the 17 Group B participants with high-risk ESFT, 12 received window therapy and are considered evaluable for this outcome.||participants|||Number
854027|NCT01832090|Secondary|≥ 1-point Change on the Merz Hand Grading Scale (MHGS), by Subject, Among All Treated Subjects With and Without Retreatment|"To evaluate the efficacy of Radiesse for hand treatment as measured by ≥ 1-point change on the 5-point Merz Hand Grading Scale (MHGS) between baseline and 3, 6, 9, and 12 months, by subject, among treated subjects with and without retreatment. A measure of successful or improved treatment effect is demonstrated by a decrease in MHGS score.
MHGS categories are as follows:
0 = no loss of fatty tissue;
1 = mild loss of fatty tissue; slight visibility of veins; 3 = moderate loss of fatty tissue; mild visibility of veins and tendons; 4 = severe loss of fatty tissue; moderate visibility of veins and tendons; and 5 = very severe loss of fatty tissue; marked visibility of veins and tendons."|3, 6, 9, and 12 months from baseline|Single withdrawn subject did not receive treatment and is not included in this analysis.||percentage of participants|||Number
854028|NCT01832090|Secondary|≥ 1-point Change on the Merz Hand Grading Scale (MHGS), by Hand, Among All Treated Subjects With and Without Retreatment|"To evaluate the efficacy of Radiesse for hand treatment as measured by ≥ 1-point change on the 5-point Merz Hand Grading Scale (MHGS) between baseline and 3, 6, 9 and 12 months, by hand, among treated subjects with and without retreatment. A measure of successful or improved treatment effect is demonstrated by a decrease in MHGS score.
MHGS categories are as follows:
0 = no loss of fatty tissue;
1 = mild loss of fatty tissue; slight visibility of veins; 3 = moderate loss of fatty tissue; mild visibility of veins and tendons; 4 = severe loss of fatty tissue; moderate visibility of veins and tendons; and 5 = very severe loss of fatty tissue; marked visibility of veins and tendons."|3, 6, 9, and 12 months from baseline|Single withdrawn subject did not receive treatment and is not included in this analysis.||% hands with ≥ 1 point MHGS change|Hands||Number
854029|NCT01832090|Secondary|Mean Change on the Merz Hand Grading Scale (MHGS), by Hand, Among All Treated Subjects With Retreatment|"To evaluate the efficacy of Radiesse for hand treatment as measured by mean change on the 5-point Merz Hand Grading Scale (MHGS) between baseline and 3, 6, 9, and 12 months, by hand, among all treated subjects receiving retreatment. A measure of successful or improved treatment effect is demonstrated by a decrease in MHGS score.
MHGS categories are as follows:
0 = no loss of fatty tissue;
1 = mild loss of fatty tissue; slight visibility of veins; 3 = moderate loss of fatty tissue; mild visibility of veins and tendons; 4 = severe loss of fatty tissue; moderate visibility of veins and tendons; and 5 = very severe loss of fatty tissue; marked visibility of veins and tendons."|3, 6, 9, and 12 months from baseline|Single withdrawn subject did not receive treatment and is not included in this analysis.||units on a scale|Hands|Standard Deviation|Mean
854030|NCT01832090|Secondary|Mean Change on the Merz Hand Grading Scale (MHGS), by Hand, Among All Treated Subjects Without Retreatment|"To evaluate the efficacy of Radiesse for hand treatment as measured by mean change on the 5-point Merz Hand Grading Scale (MHGS) between baseline and 3, 6, 9, and 12 months, by hand, among all treated subjects without retreatment. A measure of successful or improved treatment effect is demonstrated by a decrease in MHGS score.
MHGS categories are as follows:
0 = no loss of fatty tissue;
1 = mild loss of fatty tissue; slight visibility of veins; 3 = moderate loss of fatty tissue; mild visibility of veins and tendons; 4 = severe loss of fatty tissue; moderate visibility of veins and tendons; and 5 = very severe loss of fatty tissue; marked visibility of veins and tendons."|3, 6, 9, and 12 months from baseline|Single withdrawn subject did not receive treatment and is not included in this analysis.||units on a scale|Hands|Standard Deviation|Mean
854031|NCT01832090|Secondary|Global Aesthetic Improvement Scale (GAIS) Ratings Among the Original Treatment Group Only|To evaluate the efficacy of Radiesse for hand treatment by evaluating subject-reported, live Global Aesthetic Improvement Scale (GAIS) ratings at 3 months when compared to baseline among the original treatment group only|3 months from baseline|"Single withdrawn subject imputed as no change"||percentage of participants|Hands||Number
854032|NCT01832090|Secondary|Evenness in the Left Hand Versus the Right Hand Using the Merz Hand Grading Scale (MHGS) Among the Original Treatment Group Only|"To evaluate the efficacy of Radiesse for hand treatment by comparing the evenness in the left hand versus the right hand at 3 months using the 5-point Merz Hand Grading Scale (MHGS) among the original treatment group only. A measure of successful or improved treatment effect is demonstrated by a decrease in MHGS score.
MHGS categories are as follows:
0 = no loss of fatty tissue;
1 = mild loss of fatty tissue; slight visibility of veins; 3 = moderate loss of fatty tissue; mild visibility of veins and tendons; 4 = severe loss of fatty tissue; moderate visibility of veins and tendons; and 5 = very severe loss of fatty tissue; marked visibility of veins and tendons."|3 months from baseline|"Single withdrawn subject imputed as no change"||percentage of participants|||Number
854033|NCT01832090|Secondary|≥ 1-point Change on Merz Hand Grading Scale (MHGS), by Subject, With Subjects Stratified by Age < 60 Years or ≥ 60 Years|"To evaluate the efficacy of Radiesse for hand treatment as measured by a ≥ 1-point change on the 5-point Merz Hand Grading Scale (MHGS) between baseline and 3 months, by subject, among treated subjects and untreated controls, stratified by age < 60 years or ≥ 60 years. A measure of successful or improved treatment effect is demonstrated by a decrease in MHGS score.
MHGS categories are as follows:
0 = no loss of fatty tissue;
1 = mild loss of fatty tissue; slight visibility of veins; 3 = moderate loss of fatty tissue; mild visibility of veins and tendons; 4 = severe loss of fatty tissue; moderate visibility of veins and tendons; and 5 = very severe loss of fatty tissue; marked visibility of veins and tendons."|3 months from baseline|"Single withdrawn subject imputed as no change"||percentage of participants|||Number
854034|NCT01832090|Secondary|≥ 1-point Change on Merz Hand Grading Scale (MHGS), by Hand, With Subjects Stratified by Age < 60 Years or ≥ 60 Years|"To evaluate the efficacy of Radiesse for hand treatment as measured by a ≥ 1-point change on the 5-point Merz Hand Grading Scale (MHGS) between baseline and 3 months, by hand, among treated subjects and untreated controls, stratified by age < 60 years or ≥ 60 years. A measure of successful or improved treatment effect is demonstrated by a decrease in MHGS score.
MHGS categories are as follows:
0 = no loss of fatty tissue;
1 = mild loss of fatty tissue; slight visibility of veins; 3 = moderate loss of fatty tissue; mild visibility of veins and tendons; 4 = severe loss of fatty tissue; moderate visibility of veins and tendons; and 5 = very severe loss of fatty tissue; marked visibility of veins and tendons."|3 months from baseline|"Single withdrawn subject imputed as no change"||percentage of hands|Hand||Number
854117|NCT01703169|Secondary|Characterization of the PK Profile of Eltrombopag in Patients With Moderate to Very Severe Aplastic Anemia. Evaluated With AUC, Cmax, Cmin, Tmax.|Samples will for PK analysis will collected as a trough level weeks 2, 6 and 12, prior to dose of eltrombopag. Additional PK level drawn at 2, 4 and 6 hours post-dose at the scheduled week 2 visit.|Weeks 2, 6 and 12|Data was not collected for this outcome variable.|||||
854035|NCT01832090|Secondary|Mean Change on Merz Hand Grading Scale (MHGS), by Hand, With Subjects Stratified by Age < 60 Years or ≥ 60 Years|"To evaluate the efficacy of Radiesse for hand treatment as measured by mean change on the 5-point Merz Hand Grading Scale (MHGS) between baseline and 3 months, by hand, among treated subjects and untreated controls, stratified by age < 60 years or ≥ 60 years. A measure of successful or improved treatment effect is demonstrated by a decrease in MHGS score.
MHGS categories are as follows:
0 = no loss of fatty tissue;
1 = mild loss of fatty tissue; slight visibility of veins; 3 = moderate loss of fatty tissue; mild visibility of veins and tendons; 4 = severe loss of fatty tissue; moderate visibility of veins and tendons; and 5 = very severe loss of fatty tissue; marked visibility of veins and tendons."|3 months from baseline|"Single withdrawn subject imputed as no change"||units on a scale|Hands|Standard Deviation|Mean
854036|NCT01832090|Primary|≥ 1-point Change on the 5-point Merz Hand Grading Scale (MHGS), by Subject|"To evaluate the efficacy of Radiesse for hand treatment as measured by a ≥ 1-point change on the 5-point Merz Hand Grading Scale (MHGS) between baseline and 3 months, by subject, among treated subjects and untreated controls. A measure of successful or improved treatment effect is demonstrated by a decrease in MHGS score.
MHGS categories are as follows:
0 = no loss of fatty tissue;
1 = mild loss of fatty tissue; slight visibility of veins; 3 = moderate loss of fatty tissue; mild visibility of veins and tendons; 4 = severe loss of fatty tissue; moderate visibility of veins and tendons; and 5 = very severe loss of fatty tissue; marked visibility of veins and tendons."|3 months from baseline|All primary effectiveness analyses were performed based on the intent-to-treat (ITT) population. This population includes all subjects randomized. One subject was randomized but did not receive treatment and was imputed as “No change” for the primary endpoint.||percentage of participants|||Number
854037|NCT01832090|Primary|≥ 1-point Change on the 5-point Merz Hand Grading Scale (MHGS), by Hand|"To evaluate the efficacy of Radiesse for hand treatment as measured by a ≥ 1-point change on the 5-point Merz Hand Grading Scale (MHGS) between baseline and 3 months, by hand, among treated subjects and untreated controls. A measure of successful or improved treatment effect is demonstrated by a decrease in MHGS score.
MHGS categories are as follows:
0 = no loss of fatty tissue;
1 = mild loss of fatty tissue; slight visibility of veins; 3 = moderate loss of fatty tissue; mild visibility of veins and tendons; 4 = severe loss of fatty tissue; moderate visibility of veins and tendons; and 5 = very severe loss of fatty tissue; marked visibility of veins and tendons."|3 months from baseline|All primary effectiveness analyses were performed based on the intent-to-treat (ITT) population. This population includes all subjects randomized. One subject was randomized but did not receive treatment and was imputed as “No change” for the primary endpoint.||percentage of hands|Hands||Number
854038|NCT01832090|Primary|Mean Change on Merz Hand Grading Scale (MHGS), by Hand|"To evaluate the efficacy of Radiesse for hand treatment as measured by a mean change on the 5-point Merz Hand Grading Scale (MHGS) between baseline and 3 months, by hand, among treated subjects and untreated controls. A measure of successful or improved treatment effect is demonstrated by a decrease in MHGS score.
MHGS categories are as follows:
0 = no loss of fatty tissue;
1 = mild loss of fatty tissue; slight visibility of veins; 3 = moderate loss of fatty tissue; mild visibility of veins and tendons; 4 = severe loss of fatty tissue; moderate visibility of veins and tendons; and 5 = very severe loss of fatty tissue; marked visibility of veins and tendons."|3 months from baseline|All primary effectiveness analyses were performed based on the intent-to-treat (ITT) population. This population includes all subjects randomized. One subject was randomized but did not receive treatment and was imputed as “No change” for the primary endpoint.||units on a scale|Hands|Standard Deviation|Mean
854039|NCT01786902|Other Pre-specified|Changes in Anti-growth Hormone Antibody||baseline and 26 weeks|||ng/mL||Standard Deviation|Mean
854040|NCT01786902|Secondary|Changes in Height Standard Deviation Score After 26 Weeks|The Height Standard Deviation Score was calculated as height minus reference mean height divided by the standard deviation of the reference mean height, both given by a reference growth table for the corresponding chronological age at the height measurement. Greater Height Standard Deviation Score indicates greater height.|26 weeks|||ratio||Standard Deviation|Mean
854041|NCT01786902|Primary|Annualized Height Velocity(cm/Year) After 26 Weeks|Height Velocity calculated with height measured at Baseline and after 26 weeks was converted to annual growth rate.|26 weeks|||cm/year||Standard Deviation|Mean
854118|NCT01703169|Secondary|Number of Patients With AE to Measure Toxicity, Using NCI CTCAE|Evaluated weekly, up to 12 weeks. Association between eltrombopag use, dose, and tolerability in patients with moderate to very severe aplastic anemia|12 weeks|Data was not collected for this outcome variable.|||||
854076|NCT01732458|Primary|Percentage of Participants Discontinuing Study Due to an AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR’s product, whether or not considered related to the use of the product. Any worsening of a pre-existing condition which is temporally associated with the use of the SPONSOR’s product, was also an AE. Changes resulting from normal growth and development which did not vary significantly in frequency or severity from expected levels were not to be considered adverse events. Vomiting and retching were not defined as AEs during the period of data collection (24 hours following the end of surgery) unless they met the definition of an SAE. The percentage of participants discontinuing study due to an AE was reported by dose group.|From pre-operative phase up to Follow-up (Day 1 to Day 15)|All randomized participants who received at least one dose of study treatment were analyzed.||percentage of participants|||Number
854077|NCT01732458|Primary|Percentage of Participants Experiencing at Least One Adverse Event (AE)|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR’s product, whether or not considered related to the use of the product. Any worsening of a pre-existing condition which is temporally associated with the use of the SPONSOR’s product, was also an AE. Changes resulting from normal growth and development which did not vary significantly in frequency or severity from expected levels were not to be considered adverse events. Vomiting and retching were not defined as AEs during the period of data collection (24 hours following the end of surgery) unless they met the definition of an SAE. The percentage of participants experiencing ≥1 AE was reported by dose group.|From pre-operative phase up to Follow-up (Day 1 to Day 15)|All randomized participants who received at least one dose of study treatment were analyzed.||percentage of participants|||Number
854078|NCT01732458|Primary|Apparent Terminal Half-life (t ½) of Aprepitant Following Administration of Single Dose|Plasma for aprepitant t ½ assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. t ½ data were to be log transformed and analyzed via a linear mixed-effects model containing fixed effects for age for each dose level tested.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Due to the lack of samples beyond 8 hours after dose, the assessment of the terminal elimination phase of the PK profiles was limited and derivation of parameters dependent on lambda (e.g. t ½) was not possible.|||||
854079|NCT01732458|Primary|Apparent Total Clearance (CL/F) of Aprepitant From Plasma Following Administration of Single Dose|Plasma for aprepitant CL/F assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. CL/F data were to be log transformed and analyzed via a linear mixed-effects model containing fixed effects for age for each dose level tested.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Due to the lack of samples beyond 8 hours after dose, the assessment of the terminal elimination phase of the PK profiles was limited and derivation of parameters dependent on lambda (e.g. CL/F) was not possible.|||||
854080|NCT01732458|Primary|Area Under the Concentration-time Curve of Aprepitant From Time 0 to Infinity (AUC0-inf) Following Administration of Single Dose|Plasma for aprepitant AUC0-inf assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. AUC0-inf data were to be log transformed and analyzed via a linear mixed-effects model containing fixed effects for age for each dose level tested.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Due to the lack of samples beyond 8 hours after dose, the assessment of the terminal elimination phase of the PK profiles was limited and derivation of parameters dependent on lambda (e.g. AUC0-inf) was not possible.|||||
854119|NCT01703169|Secondary|Hematology Labs|Association between eltrombopag use and response in hemoglobin, hematocrit, total white blood cell count, and absolute neutrophil count to be evaluate by maximal hemoglobin, hematocrit, total white blood cell count, and absolute neutrophil counts achieved in patients with moderate to very severe aplastic anemia|12 weeks|Data was not collected for this outcome variable.|||||
854081|NCT01732458|Primary|Tmax of Aprepitant Following Administration of 10 mg Dose Equivalent in Birth to <2 Year Age Group|Tmax was analyzed independently for participants in the 10 mg dose equivalent arm aged from birth to <2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged birth to <2 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.||hr||Geometric Coefficient of Variation|Geometric Mean
854082|NCT01732458|Primary|Cmax of Aprepitant Following Administration of 10 mg Dose Equivalent in Birth to <2 Year Age Group|Cmax was analyzed independently for participants in the 10 mg dose equivalent arm aged from birth to <2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged birth to <2 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
854083|NCT01732458|Primary|AUC0-last of Aprepitant Following Administration of 10 mg Dose Equivalent in Birth to <2 Year Age Group|AUC0-last was analyzed independently for participants in the 10 mg dose equivalent arm aged from birth to <2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged birth to <2 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
854084|NCT01732458|Primary|Tmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 2 to <6 Year Age Group|Tmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 2 to <6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 2 to <6 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.||hr||Geometric Coefficient of Variation|Geometric Mean
854085|NCT01732458|Primary|Cmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 2 to <6 Year Age Group|Cmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 2 to <6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 2 to <6 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
854086|NCT01732458|Primary|AUC0-last of Aprepitant Following Administration of 10 mg Dose Equivalent in 2 to <6 Year Age Group|AUC0-last was analyzed independently for participants in the 10 mg dose equivalent arm aged 2 to <6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 2 to <6 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
854120|NCT01703169|Secondary|Platelet Count Twice Baseline.|Proportion of subjects who achieve platelet counts at least twice their baseline value at any point while on study medication, in patients with moderate to very severe aplastic anemia.|Between weeks 1-12.|Data was not collected for this outcome variable.|||||
854087|NCT01732458|Primary|Tmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 6 to <12 Year Age Group|Tmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 6 to <12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 6 to <12 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.||hr||Geometric Coefficient of Variation|Geometric Mean
854088|NCT01732458|Primary|Cmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 6 to <12 Year Age Group|Cmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 6 to <12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 6 to <12 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
854089|NCT01732458|Primary|AUC0-last of Aprepitant Following Administration of 10 mg Dose Equivalent in 6 to <12 Year Age Group|AUC0-last was analyzed independently for participants in the 10 mg dose equivalent arm aged 6 to <12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 6 to <12 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
854090|NCT01732458|Primary|Tmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 12 to 17 Year Age Group|Tmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 12 to 17 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.||hr||Geometric Coefficient of Variation|Geometric Mean
854091|NCT01732458|Primary|Cmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 12 to 17 Year Age Group|Cmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 12 to 17 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
854092|NCT01732458|Primary|AUC0-last Following Administration of 10 mg Dose Equivalent in 12 to 17 Year Age Group|AUC0-last was analyzed independently for participants in the 10 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 12 to 17 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
854121|NCT01703169|Primary|Proportion of Participants With Platelet Response|Defined as a stable platelet count of 50,000/μl or more during any 4 week period within the possible 12 weeks while on study,and including maximal platelet counts achieved in patients with moderate to very severe aplastic anemia.|up to 12 weeks|||proportion of participants||95% Confidence Interval|Number
854093|NCT01732458|Primary|Tmax of Aprepitant Following Administration of 40 mg Dose Equivalent in Birth to <2 Year Age Group|Tmax was analyzed independently for participants in the 40 mg dose equivalent arm aged birth to <2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged birth to <2 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed.||hr||Geometric Coefficient of Variation|Geometric Mean
854094|NCT01732458|Primary|Cmax of Aprepitant Following Administration of 40 mg Dose Equivalent in Birth to <2 Year Age Group|Cmax was analyzed independently for participants in the 40 mg dose equivalent arm aged birth to <2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged birth to <2 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed. One participant was excluded from the analysis due aprepitant concentration in the pre-dose sample.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
854095|NCT01732458|Primary|AUC0-last of Aprepitant Following Administration of 40 mg Dose Equivalent in Birth to <2 Year Age Group|AUC0-last was analyzed independently for participants in the 40 mg dose equivalent arm aged birth to <2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged birth to <2 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed. One participant was excluded from the analysis due aprepitant concentration in the pre-dose sample.||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
854096|NCT01732458|Primary|Tmax of Aprepitant Following Administration of 40 mg Dose Equivalent in 2 to <6 Year Age Group|Tmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 2 to <6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 2 to <6 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed.||hr||Geometric Coefficient of Variation|Geometric Mean
854097|NCT01732458|Primary|Cmax of Aprepitant Following Administration of 40 mg Dose Equivalent in 2 to <6 Year Age Group|Cmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 2 to <6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 2 to <6 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
854098|NCT01732458|Primary|AUC0-last of Aprepitant Following Administration of 40 mg Dose Equivalent in 2 to <6 Year Age Group|AUC0-last was analyzed independently for participants in the 40 mg dose equivalent arm aged 2 to <6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 2 to <6 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed.||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
854099|NCT01732458|Primary|Tmax of Aprepitant Following Administration of 40 mg Dose Equivalent in 6 to <12 Year Age Group|Tmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 6 to <12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 6 to <12 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed.||hr||Geometric Coefficient of Variation|Geometric Mean
854100|NCT01732458|Primary|Cmax of Aprepitant Following Administration of 40 mg Dose Equivalent in 6 to <12 Year Age Group|Cmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 6 to <12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 6 to <12 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
854101|NCT01732458|Primary|AUC0-last of Aprepitant Following Administration of 40 mg Dose Equivalent in 6 to <12 Year Age Group|AUC0-last was analyzed independently for participants in the 40 mg dose equivalent arm aged 6 to <12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 6 to <12 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed.||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
854102|NCT01732458|Primary|Tmax Following Administration of 40 mg Dose Equivalent in 12 to 17 Year Age Group|Tmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 12 to 17 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed.||hr||Geometric Coefficient of Variation|Geometric Mean
854103|NCT01732458|Primary|Cmax Following Administration of 40 mg Dose Equivalent in 12 to 17 Year Age Group|Cmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 12 to 17 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
854104|NCT01732458|Primary|AUC0-last Following Administration of 40 mg Dose Equivalent in 12 to 17 Year Age Group|AUC0-last was analyzed independently for participants in the 40 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 12 to 17 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed.||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
854105|NCT01732458|Primary|Tmax of Aprepitant Following Administration of 125 mg Dose Equivalent in Birth to <2 Year Age Group|Tmax was analyzed independently for participants in the 125 mg dose equivalent arm aged birth to <2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged birth to <2 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed.||hr||Geometric Coefficient of Variation|Geometric Mean
854106|NCT01732458|Primary|Cmax of Aprepitant Following Administration of 125 mg Dose Equivalent in Birth to <2 Year Age Group|Cmax was analyzed independently for participants in the 125 mg dose equivalent arm aged birth to <2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged birth to <2 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed. One participant was excluded from the analysis due to aprepitant concentration in the pre-dose sample.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
854107|NCT01732458|Primary|AUC0-last of Aprepitant Following Administration of 125 mg Dose Equivalent in Birth to <2 Year Age Group|AUC0-last was analyzed independently for participants in the 125 mg dose equivalent arm aged birth to <2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged birth to <2 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed. Two participants were excluded from the analysis, due to a missing 8-hour post-dose sample and aprepitant concentration in the pre-dose sample, respectively.||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
854108|NCT01732458|Primary|Tmax of Aprepitant Following Administration of 125 mg Dose Equivalent in 2 to <6 Year Age Group|Tmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 2 to <6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 2 to <6 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed.||hr||Geometric Coefficient of Variation|Geometric Mean
854109|NCT01732458|Primary|Cmax of Aprepitant Following Administration of 125 mg Dose Equivalent in 2 to <6 Year Age Group|Cmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 2 to <6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 2 to <6 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
854110|NCT01732458|Primary|AUC0-last of Aprepitant Following Administration of 125 mg Dose Equivalent in 2 to <6 Year Age Group|AUC0-last was analyzed independently for participants in the 125 mg dose equivalent arm aged 2 to <6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 2 to <6 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed.||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
854111|NCT01732458|Primary|Tmax of Aprepitant Following Administration of 125 mg Dose Equivalent in 6 to <12 Year Age Group|Tmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 6 to <12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 6 to <12 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed.||hr||Geometric Coefficient of Variation|Geometric Mean
854112|NCT01732458|Primary|Cmax of Aprepitant Following Administration of 125 mg Dose Equivalent in 6 to <12 Year Age Group|Cmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 6 to <12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 6 to <12 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
854113|NCT01732458|Primary|AUC0-last of Aprepitant Following Administration of 125 mg Dose Equivalent in 6 to <12 Year Age Group|AUC0-last was analyzed independently for participants in the 125 mg dose equivalent arm aged 6 to <12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 6 to <12 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed.||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
854114|NCT01732458|Primary|Time to Maximum Concentration (Tmax) of Aprepitant Following Administration of 125 mg Dose Equivalent in 12 to 17 Year Age Group|Tmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 12 to 17 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed.||hour (hr)||Geometric Coefficient of Variation|Geometric Mean
854115|NCT01732458|Primary|Maximum Concentration (Cmax) of Aprepitant Following Administration of 125 mg Dose Equivalent in 12 to 17 Year Age Group|Cmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 12 to 17 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
854116|NCT01732458|Primary|Area Under the Concentration-time Curve of Aprepitant From Time 0 to the Last Measurable Concentration (AUC0-last) Following Administration of 125 mg Dose Equivalent in 12 to 17 Year Age Group|AUC0-last was analyzed independently for participants in the 125 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using a noncompartmental analysis (NCA). The limit of quantitation (LOQ) value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 12 to 17 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed.||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
854133|NCT01520207|Primary|Determine the Efficacy of Mannitol Administration in Reducing the Frequency of Intra-dialytic Hypotension During the First Three Hemodialysis Initiation Sessions.|BP decline during first three sessions|First three hemodialysis sessions (5 days)|SBP decline||mmHg||Standard Deviation|Mean
854173|NCT01503164|Secondary|Glucose Effectiveness (SG)|Glucose effectiveness is the ability for glucose to move intracellularly in the absence of insulin. It is a parameter that results from the MINMOD analysis of the serum glucose and insulin levels derived from the frequently sampled intravenous glucose tolerance test. Low SG indicates a lower predisposition for glucose disposal independent of any effects of insulin.|2 months after intervention|55 randomized to PAP (2 dropout); 56 randomized to lifestyle (1 dropout)||[min]^-1||Standard Deviation|Mean
854960|NCT00790569|Primary|Rates of Smoking Cessation Continuous From First Quit Day to 6 Months|Number of participants who self-reported continuous abstinence from their initial quit day (study day 14) to 6 Months|6-Months|||participants|||Number
854165|NCT01503164|Secondary|Area Under the Curve Assessed by Oral Glucose Tolerance Test (OGTT)|Results of the oral glucose tolerance test will be analyzed using indices derived from the serial glucose and insulin levels over a 2 hour period 2 months post intervention. This will be the area under the glucose/ insulin curves|2 month after intervention|55 randomized to PAP (2 dropout); 56 randomized to lifestyle (1 dropout)||mg/dL per 120 min||Standard Deviation|Mean
854166|NCT01503164|Secondary|Area Under the Curve Assessed by Oral Glucose Tolerance Test|Results of the oral glucose tolerance test will be analyzed using indices derived from the serial glucose and insulin levels over the 2 hour period. This will be the area under the glucose/ insulin curves|Baseline|55 randomized to PAP (2 dropout); 56 randomized to lifestyle (1 dropout)||mg/dL per 120 min||Standard Deviation|Mean
854167|NCT01503164|Secondary|Endothelial Function|Endothelial function will be assessed using peripheral arterial tonometry using the Endo-PAT device. Using the EndoPat device, the relative vasoconstriction of occluded versus non-occluded arms was derived and provided the relative hyperemic index.|2 month after intervention|Data was not collected for all participants for this outcome measure. Participants for whom data was available are included in analysis.||ratio||Standard Deviation|Mean
854168|NCT01503164|Secondary|Endothelial Function|Endothelial function will be assessed using peripheral arterial tonometry using the Endo-PAT device. Using the EndoPat device, the relative vasoconstriction of occluded versus non-occluded arms was derived and provided the relative hyperemic index.|Baseline|Data was unable to be collected for all participants in this outcome measure.||ratio of occluded versus non-occluded||Standard Deviation|Mean
854169|NCT01503164|Secondary|Acute Insulin Response to Glucose (AIRG)|The acute insulin response to glucose (AIRG) value is derived from the MINMOD analysis of the glucose and insulin levels obtained during the frequently sampled intravenous glucose tolerance test. A low AIRG indicates decreased ability of the pancreas to secrete insulin.|2 months after intervention|55 randomized to PAP (2 dropout); 56 randomized to lifestyle (1 dropout)||[mU/L-min]||Standard Deviation|Mean
854170|NCT01503164|Secondary|Acute Insulin Response to Glucose (AIRG)|The acute insulin response to glucose (AIRG) value is derived from the MINMOD analysis of the glucose and insulin levels obtained during the frequently sampled intravenous glucose tolerance test. A low AIRG indicates decreased ability of the pancreas to secrete insulin.|Baseline|55 randomized to PAP (2 dropout); 56 randomized to lifestyle (1 dropout)||[mU/L-min]||Standard Deviation|Mean
854171|NCT01503164|Secondary|Disposition Index (DI)|The disposition index is the mathematical product of insulin sensitivity (SI) and acute insulin response to glucose (AIRG) both of which are derived from the MINMOD analysis of the frequently sampled intravenous glucose tolerance test data.|2 months after intervention|55 randomized to PAP (2 dropout); 56 randomized to lifestyle (1 dropout)||[mU/L]^-1 x [min]^-1] x [mU/L-min]||Standard Deviation|Mean
854172|NCT01503164|Secondary|Disposition Index (DI)|The disposition index is the mathematical product of insulin sensitivity (SI) and acute insulin response to glucose (AIRG) both of which are derived from the MINMOD analysis of the frequently sampled intravenous glucose tolerance test data. A low DI is indicative of a higher risk of developing diabetes.|Baseline|55 randomized to PAP (2 dropout); 56 randomized to lifestyle (1 dropout)||[mU/L]^-1 x [min]^-1] x [mU/L-min]||Standard Deviation|Mean
854961|NCT00790569|Primary|Carbon Monoxide (CO)-Confirmed 7-day Abstinence|Number of participants reporting 7-day abstinence at 6-months, confirmed with CO measurement.|6-Months|||participants|||Number
854962|NCT00790569|Secondary|Reinforcing Effects of Smoking||12 months||||||
854175|NCT01503164|Primary|Insulin Sensitivity (SI)|"Insulin sensitivity will be determined with the insulin-modified frequently sampled intravenous glucose tolerance test (IVGTT) before and 2-months after study intervention. This test requires administration of a weight-adjusted dose of D50W as an IV bolus at time zero. After the glucose bolus, blood samples are drawn at the scheduled times for 3-hours. At the 20-minute mark, a weight-adjusted dose of regular insulin is administered. The resulting serum is analyzed for glucose and insulin and the minimal model (MINMOD) will be used to derive insulin sensitivity. A low SI signifies low insulin sensitivity and high SI represents high insulin sensitivity."|2 months after intervention|55 randomized to PAP (2 dropout); 56 randomized to lifestyle (1 dropout)||[mU/L]^-1 x [min]^-1||Standard Deviation|Mean
854176|NCT01503164|Primary|Insulin Sensitivity (SI)|"Insulin sensitivity will be determined with the insulin-modified frequently sampled intravenous glucose tolerance test (IVGTT) before and 2-months after study intervention. This test requires administration of a weight-adjusted dose of D50W as an IV bolus at time zero. After the glucose bolus, blood samples are drawn at the scheduled times for 3-hours. At the 20-minute mark, a weight-adjusted dose of regular insulin is administered. The resulting serum is analyzed for glucose and insulin and the minimal model (MINMOD) will be used to derive insulin sensitivity. A low SI signifies low insulin sensitivity and high SI represents high insulin sensitivity."|Baseline|55 randomized to PAP (2 dropout); 56 randomized to lifestyle (1 dropout)||[mU/L]^-1 x [min]^-1||Standard Deviation|Mean
854963|NCT00790569|Secondary|Use of Illicit Drugs as Measured by Urine Toxicologies||12 months||||||
854964|NCT00790569|Secondary|Methadone Dose Changes||12 months||||||
854965|NCT00790569|Secondary|Retention in Methadone Maintenance||12 months||||||
854966|NCT00790569|Secondary|Withdrawal Symptoms||12 months||||||
854967|NCT00790569|Secondary|Smoking Urges||12 months||||||
854222|NCT01451463|Other Pre-specified|Six Condition Romberg Test|The Six Condition Romberg Test is used assess static balance. Subjects are tested standing with their arms crossed over their chests and are assessed for 30 seconds in the following six conditions: 1) feet together, 2) feet together eyes closed, 3) feet aligned in tandem heel-to-toe position eyes open, 4) feet aligned in tandem heel-to-toe position eyes closed, 5) standing in tandem position while counting backwards by 3's from 100 with eyes open, 6) standing in tandem position while counting backwards by 3's from 100 with eyes closed. Comparison of performances were made when off stable dose of tetrabenazine for 20 hours to performance 2 hours after resumption of tetrabenazine. If a participant could not hold a stance for the full 30 seconds, then that component of the Romberg test ended at that point with the time of that component scored in seconds; 30 seconds being the maximum score for each of the 6 tests. The total score was calculated as a sum of all of the 6 subset scores.|2 hours|||Six Condition Romberg Test score||Standard Deviation|Mean
854223|NCT01451463|Secondary|Five Times Sit to Stand Test|Subjects are asked to sit in a chair with their arms across their chests and asked to stand and sit five times in a row. The time it takes to complete 5 sit to stand cycles is timed with a stop watch. Comparison is made when off stable dose of tetrabenazine for 18 hours to performance two hours after resumption of tetrabenazine. Lower time scores are associated with better balance.|18-20 hours|||seconds to complete 5 sit to stand cycle||Standard Deviation|Mean
854224|NCT01451463|Primary|Tinetti Mobility Test Score|The Tinetti Mobility Test is a clinical test used to assess balance and gait. The Balance sub-score ranges from 0-16 (with 16 reflecting better balance) while the Gait sub-score ranges from 0-12 (with 12 reflecting better gait parameters). The Total Tinetti Mobility Test Score (TMT) is a sum of the two sub-scores with a maximum score of 28. The higher the score the better the gait and balance performance. A comparison of scores off regular stable dose of tetrabenazine for >18 hours with the performance two hours after resuming tetrabenazine was made.|18-20 hours|||Total Tinetti Mobility Test Score (TMT)||Standard Deviation|Mean
854239|NCT01285310|Secondary|Percentage of Participants Who Achieve the European League Against Rheumatism (EULAR) Response Criteria Using CRP at Year 2|"EULAR response criteria classify each participant as a good, moderate or non-responder to treatment based on the degree of improvement from baseline and the level of disease activity at the endpoint. EULAR response is derived using the individual subject's DAS28 as the measure of severity of disease.
Good or moderate response is defined as follows: Good response: DAS28 at the time point ≤ 3.2 and improvement from baseline > 1.2 Moderate response: DAS28 at the time point > 3.2 and improvement from baseline > 1.2, or DAS28 at the time point ≤ 5.1 and improvement from baseline > 0.6 and ≤ 1.2
The study was terminated before the 2–year time point was reached due to lack of clinical efficacy."|Baseline and Year 2|Analysis not performed.|||||
854437|NCT01101880|Primary|Duration of Remission|With 50 patients, the rates of these endpoints will be estimated with a standard error of 5 to 7 percentage points, depending on the observed rates. Remission is defined as less than 5% blasts in the bone marrow, no appearance of blasts in the peripheral blood, and no extramedullary disease (appearance of leukemic cells in other tissues).|Up to 5 years|||weeks||Full Range|Median
854240|NCT01285310|Secondary|Percentage of Participants Who Achieve an Improvement of at Least 4 Units From Baseline in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) at Year 2|"The FACIT-Fatigue scale was a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue.
The study was terminated before the 2–year time point was reached due to lack of clinical efficacy."|Baseline and Year 2|Analysis not performed.|||||
854241|NCT01285310|Secondary|Percentage of Participants With an American College of Rheumatology 70% Improvement (ACR 70) Response at Year 2|"Percentage of participants with an American College of Rheumatology 70% Improvement (ACR 70) response. A participant was a responder if the following 3 criteria for improvement from baseline were met:
≥ 70% improvement in 68 tender joint count;
≥ 70% improvement in 66 swollen joint count; and
≥ 70% improvement in at least 3 of the 5 following parameters: Subject's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Subject's global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Subject's self-assessment of physical function (Health Assessment Questionnaire - Disability Index ([HAQ-DI]); C-Reactive Protein
The study was terminated before the 2–year time point was reached due to lack of clinical efficacy."|Baseline and Year 2|Analysis not performed.|||||
854242|NCT01285310|Secondary|Percentage of Participants With an American College of Rheumatology 50% Improvement (ACR 50) Response at Year 2|"Percentage of participants with an American College of Rheumatology 50% Improvement (ACR 50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:
≥ 50% improvement in 68 tender joint count;
≥ 50% improvement in 66 swollen joint count; and
≥ 50% improvement in at least 3 of the 5 following parameters: Subject's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Subject's global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Subject's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [(HAQ-DI)]); C-Reactive Protein.
The study was terminated before the 2–year time point was reached due to lack of clinical efficacy."|Baseline and Year 2|Analysis not performed.|||||
854243|NCT01285310|Secondary|Percentage of Participants Who Achieve an Improvement of ≥ 0.22 Units From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Year 2|"The Health Assessment Questionnaire - Disability Index (HAQ-DI) was a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.
The study was terminated before the 2–year time point was reached due to lack of clinical efficacy."|Baseline and Year 2|Analysis not performed.|||||
854244|NCT01285310|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy –Fatigue (FACIT-Fatigue) at Year 2|"The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means “not at all,” and 4 means “very much.” The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue.
A positive change from baseline score indicates an improvement.
The study was terminated before the 2–year time point was reached due to lack of clinical efficacy."|Baseline and Year 2|Analysis not performed.|||||
854245|NCT01285310|Secondary|Percentage Change From Baseline in the Individual American College of Rheumatology Components at Year 2|"The Individual ACR Components were defined as follows:
Tender Joint Count (out of 68 joints)
Swollen Joint Count (out of 66 joints)
Subject Assessment of Pain (0 to 100 mm VAS)
Subject Global Assessment of Disease Activity (0 to 100 mm VAS)
Physician Global Assessment of Disease Activity (0 to 100 mm VAS)
HAQ-DI Score
Acute Phase Reactant High Sensitivity C-Reactive Protein (hsCRP, mg/dL) Erythrocyte Sedimentation Rate (ESR)
The study was terminated before the 2–year time point was reached due to lack of clinical efficacy."|Baseline and Year 2|Analysis not performed.|||||
854246|NCT01285310|Secondary|Change From Baseline in Disease Activity Score 28 (DAS28) (Using C-Reactive Protein) (CRP) at Year 2|"The DAS 28 measures the severity of disease at a specific time and is derived from the following variables:
28 tender joint count (TJC28)
28 swollen joint count (SJC28), which do not include the distal interphalangeal (DIP) joints, the hip joint, or the joints below the knee;
C-reactive protein (CRP)
Subject's global assessment of disease activity (SGA ). A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission.
DAS28 values range from 2.0 to 10.0 while higher values mean a higher disease activity.
The study was terminated before the 2–year time point was reached due to lack of clinical efficacy."|Baseline and Year 2|Analysis not performed.|||||
854247|NCT01285310|Secondary|Percentage of Participants Who Achieve Low Disease Activity or Remission Based on the Clinical Disease Activity Index (CDAI) ≤ 10 at Year 2|"The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:
28 tender joint count (TJC),
28 swollen joint count (SJC),
Subject's Global Assessment of Disease Activity measured on a 10 mm visual analog scale (VAS), where 0 mm = lowest disease activity and 10 mm = highest;
Physician's Global Assessment of Disease Activity -measured on a 10 mm VAS, where 0 mm = lowest disease activity and 10 mm = highest.
The CDAI score ranges from 0-76 where lower scores indicate less disease activity. The following thresholds of disease activity have been defined for the CDAI:
Remission: ≤ 2.8 Low Disease Activity: > 2.8 and ≤ 10 Moderate Disease Activity: > 10 and ≤ 22 High Disease Activity: > 22
The study was terminated before the 2–year time point was reached due to lack of clinical efficacy."|Baseline and Year 2|Analysis not performed.|||||
854248|NCT01285310|Secondary|Change From Baseline in the Clinical Disease Activity Index (CDAI) at Year 2|"The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:
28 tender joint count (TJC),
28 swollen joint count (SJC),
Subject's Global Assessment of Disease Activity measured on a 10 mm visual analog scale (VAS), where 0 mm = lowest disease activity and 10 mm = highest;
Physician's Global Assessment of Disease Activity -measured on a 10 mm VAS, where 0 mm = lowest disease activity and 10 mm = highest.
The CDAI score ranges from 0-76 where lower scores indicate less disease activity. The following thresholds of disease activity have been defined for the CDAI:
Remission: ≤ 2.8 Low Disease Activity: > 2.8 and ≤ 10 Moderate Disease Activity: > 10 and ≤ 22 High Disease Activity: > 22
The study was terminated before the 2–year time point was reached due to lack of clinical efficacy."|Baseline and Year 2|Analysis not performed.|||||
854249|NCT01285310|Secondary|Change From Baseline in the Medical Outcome Study Short Form 36-item (SF-36) Physical Functioning Domain at Year 2|"The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) was a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The concepts measured by the SF-36 are not specific to any age, disease, or treatment group, allowing comparison of relative burden of different diseases and the relative benefit of different treatments. Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from baseline score indicates an improvement.
The study was terminated before the 2–year time point was reached due to lack of clinical efficacy."|Baseline and Year 2|Analysis not performed.|||||
854250|NCT01285310|Secondary|Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Year 2|"The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.
The study was terminated before the 2–year time point was reached due to lack of clinical efficacy."|Baseline and Year 2|Analysis not performed.|||||
854251|NCT01285310|Secondary|Percentage of Participants With an American College of Rheumatology 20% Improvement (ACR 20) Response at Year 2|"Percentage of participants with an American College of Rheumatology 20% Improvement (ACR 20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:
≥ 20% improvement in 68 tender joint count;
≥ 20% improvement in 66 swollen joint count; and
≥ 20% improvement in at least 3 of the 5 following parameters: Subject's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Subject's global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Subject's self-assessment of physical function (Health Assessment Questionnaire - Disability Index ([HAQ-DI]); C-Reactive Protein.
The study was terminated before the 2–year time point was reached due to lack of clinical efficacy."|Baseline and Year 2|Analysis not performed.|||||
854252|NCT01285310|Secondary|Percentage of Participants Who Achieve the European League Against Rheumatism (EULAR) Response Criteria Using CRP at Week 52|"The EULAR response criteria classify each subject as a good, moderate or non-responder to treatment based on the degree of improvement from baseline and the level of disease activity at the endpoint. EULAR response is derived using the individual subject's DAS28 as the measure of severity of disease.
Good or moderate response is defined as follows: Good response: DAS28 at the time point ≤ 3.2 and improvement from baseline > 1.2 Moderate response: DAS28 at the time point > 3.2 and improvement from baseline > 1.2, or DAS28 at the time point ≤ 5.1 and improvement from baseline > 0.6 and ≤ 1.2"|Baseline and Week 52|The Apremilast Participants as Randomized/ Transitioned (AAR) Population; only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.||percentage of participants||95% Confidence Interval|Number
854253|NCT01285310|Secondary|Percentage of Participants Who Achieve an Improvement of at Least 4 Units From Baseline in the Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-Fatigue) at Week 52|"The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue. A positive change from baseline score indicates an improvement."|Baseline and Week 52|The Apremilast participants as Randomized/Transitioned (AAR) Population; participants with a Baseline value and a Week 52 value are included.||percentage of participants||95% Confidence Interval|Number
854254|NCT01285310|Secondary|Percentage of Participants With an American College of Rheumatology 70% Improvement (ACR 70) Response at Week 52|"Percentage of participants with an American College of Rheumatology 70% Improvement (ACR 70) response. A participant was a responder if the following 3 criteria for improvement from baseline were met:
≥ 70% improvement in 68 tender joint count;
≥ 70% improvement in 66 swollen joint count; and
≥ 70% improvement in at least 3 of the 5 following parameters: Subject's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Subject's global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Subject's self-assessment of physical function (Health Assessment Questionnaire - Disability Index ([HAQ-DI]); C-Reactive Protein"|Baseline and Week 52|Apremilast participants as randomized/transitioned (AAR Population); population consists of all participants who were randomized or transitioned to apremilast at any time during the study. Only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.||percentage of participants||95% Confidence Interval|Number
854968|NCT00790569|Primary|Self- Reported 7-day Abstinence|Number of participants with self-reported, 7-day abstinence at 6-months|6 Months|||participants|||Number
854255|NCT01285310|Secondary|Percentage of Participants With an American College of Rheumatology 50% Improvement (ACR 50) Response at Week 52|"Percentage of participants with an American College of Rheumatology 50% Improvement (ACR 50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:
≥ 50% improvement in 68 tender joint count;
≥ 50% improvement in 66 swollen joint count; and
≥ 50% improvement in at least 3 of the 5 following parameters:
Subject's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Subject's global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Subject's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [(HAQ-DI)]); C-Reactive Protein."|Baseline and Week 52|Apremilast participants as randomized during the apremilast exposure period.||percentage of participants||95% Confidence Interval|Number
854256|NCT01285310|Secondary|Percentage of Participants Who Achieve an Improvement of ≥ 0.22 Units From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 52|The Health Assessment Questionnaire - Disability Index (HAQ-DI) was a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 52|The Apremilast Participants as Randomized/Transitioned (AAR) Population; participants with a Baseline value and a Week 52 value are included.||percentage of participants||95% Confidence Interval|Number
854257|NCT01285310|Secondary|Change From Baseline in the FACIT-Fatigue Scale Score at Week 52|"The FACIT-Fatigue scale was a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue.
A positive change from baseline score indicates an improvement."|Baseline and Week 52|The Apremilast Participants as Randomized/ Transitioned (AAR) Population; participants with a Baseline value and a Week 52 value are included.||units on a scale||Standard Deviation|Mean
854258|NCT01285310|Secondary|Percentage Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 52|"The erythrocyte sedimentation rate (ESR) is a blood test that can reveal inflammatory activity. The subject's blood is placed in a tall, thin tube, red erythrocytes gradually settle to the bottom. Inflammation can cause the cells to clump together. Because these clumps of cells are denser than individual cells, they settle to the bottom more quickly.
The ESR test measures the distance red blood cells fall in a test tube in one hour. The farther the red blood cells have descended, the greater the inflammatory response."|Baseline and Week 52|The Apremilast Participants as Randomized/ Transitioned (AAR) Population; participants with a Baseline value and a Week 52 value are included.||percent change||Standard Deviation|Mean
854259|NCT01285310|Secondary|Percentage Change From Baseline in the High Sensitivity C-Reactive Protein (CRP) at Week 52|"C-Reactive Protein (CRP) is a substance produced by the liver that increases in the presence of inflammation in the body. An elevated CRP level is identified with blood tests and is considered a non-specific marker for disease."|Baseline and Week 52|The Apremilast Participants as Randomized/Transitioned (AAR) Population; participants with a Baseline value and a Week 52 value are included.||percent change||Standard Deviation|Mean
854260|NCT01285310|Secondary|Percentage Change From Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 52|The Health Assessment Questionnaire - Disability Index (HAQ-DI) was a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 52|The Apremilast Participants as Randomized/Transitioned (AAR) Population; participants with a Baseline value and a Week 52 value are included.||percent change||Standard Deviation|Mean
854261|NCT01285310|Secondary|Percentage Change From Baseline in the Physician Global Assessment of Disease Activity at Week 52|"The Physician Global Assessment of Disease Activity was measured asking the physician to assess the subject's current arthritis disease activity by placing a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents  lowest disease activity, and the right-hand boundary (score = 100 mm) represents  highest disease activity. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 52|The Apremilast participants as Randomized/Transitioned (AAR) Population; participants with a Baseline value and a Week 52 value are included.||percent change||Standard Deviation|Mean
854262|NCT01285310|Secondary|Percentage Change From Baseline in the Subject Global Assessment of Disease Activity at Week 52|"The Subject Global Assessment of Disease Activity was measured asking the participant to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents  lowest disease activity, and the right-hand boundary (score = 100 mm) represents  highest disease activity. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 52|The Apremilast participants as Randomized/Transitioned (AAR) Population; participants with a Baseline value and a Week 52 value are included.||percent change||Standard Deviation|Mean
854263|NCT01285310|Secondary|Percentage Change From Baseline in the Subject Assessment of Pain at Week 52|"The Subject Assessment of Pain was measured asking the participant to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents no pain, and the right-hand boundary (score = 100 mm) represents pain as severe as can be imagined. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 52|The Apremilast participants as Randomized/Transitioned (AAR) Population; participants with a Baseline value and a Week 52 value are included.||percent change||Standard Deviation|Mean
854264|NCT01285310|Secondary|Percentage Change From Baseline in the Swollen Joint Count at Week 52|Joint swelling is soft tissue swelling that is detectable along the joint margins and is assessed by inspection and direct palpation of the joint, by the examiner. The ACR 66 swollen joint count evaluates the following joints: upper-temporomandibular, sternoclavicular, acromioclavicular, shoulder, elbow, wrist, metacarpophalangeal, proximal interphalangeal and distal interphalangeal; lower: knee, ankle, midtarsal, metatarsophalangeal and proximal interphalangeal.|Baseline and Week 52|The Apremilast participants as Randomized/Transitioned (AAR) Population; participants with a Baseline value and a Week 52 value are included..||percent change||Standard Deviation|Mean
854265|NCT01285310|Secondary|Percentage Change From Baseline in the Tender Joint Count at Week 52|Joint tenderness is the presence of pain in a joint when pressure is applied by the examiner to elicit tenderness. The 68 tender joint count evaluates the following joints: upper-temporomandibular, sternoclavicular, acromioclavicular, shoulder, elbow, wrist, meta-carpophalangeal, proximal interphalangeal and distal interphalangeal; lower: hip, knee, ankle, midtarsal, metatarsophalangeal and proximal interphalangeal.|Baseline and Week 52|The Apremilast participants as Randomized/Transitioned (AAR) Population; participants with a Baseline value and a Week 52 value are included.||percent change||Standard Deviation|Mean
854266|NCT01285310|Secondary|Change From Baseline in the Disease Activity Score 28 (DAS 28) Using CRP at Week 52|"The DAS28 measures the severity of disease at a specific time and is derived from the following variables:
28 tender joint count (TJC28)
28 swollen joint count (SJC28), which do not include the distal interphalangeal (DIP) joints, the hip joint, or the joints below the knee;
C-reactive protein (CRP)
Subject’s global assessment of disease activity (SGA).
DAS28 values range from 2.0 to 10.0 while higher values mean a higher disease activity.
A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission."|Baseline and Week 52|The Apremilast participants as Randomized/Transitioned (AAR) Population; participants with a Baseline value and a Week 52 value are included.||units on a scale||Standard Deviation|Mean
854267|NCT01285310|Secondary|Percentage of Participants Who Achieve Low Disease Activity or Remission Based on the Clinical Disease Activity Index (CDAI) ≤ 10 at Week 52|"The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:
28 tender joint count (TJC),
28 swollen joint count (SJC),
Subject’s Global Assessment of Disease Activity measured on a 100 mm visual analog scale (VAS),, where 0 mm = lowest disease activity and 100 mm = highest;
Physician's Global Assessment of Disease Activity -measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest.
The CDAI score ranges from 0-76 where lower scores indicate less disease activity. The following thresholds of disease activity have been defined for the CDAI:
Remission: ≤ 2.8; Low Disease Activity: > 2.8 and ≤ 10; Moderate Disease Activity: > 10 and ≤ 22; High Disease Activity: > 22"|Baseline and Week 52|The Apremilast participants as Randomized/Transitioned (AAR) Population; participants with a Baseline value and a Week 52 value are included.||percentage of participants||95% Confidence Interval|Number
854268|NCT01285310|Secondary|Change From Baseline in the Clinical Disease Activity Index (CDAI) at Week 52|"The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:
28 tender joint count (TJC),
28 swollen joint count (SJC),
Subject’s Global Assessment of Disease Activity measured on a 100 mm visual analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest;
Physician's Global Assessment of Disease Activity -measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest.
The CDAI score ranges from 0-76 where lower scores indicate less disease activity. The following thresholds of disease activity have been defined for the CDAI:
Remission: ≤ 2.8; Low Disease Activity: > 2.8 and ≤ 10; Moderate Disease Activity: > 10 and ≤ 22; High Disease Activity: > 22"|Baseline and Week 52|The Apremilast participants as Randomized/Transitioned (AAR) Population; participants with a Baseline value and a Week 52 value are included.||units on a scale||Standard Deviation|Mean
854269|NCT01285310|Secondary|Change From Baseline in the Medical Outcome Study Short Form 36-item (SF-36) Physical Functioning Domain at Week 52|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.|Baseline and Week 52|The Apremilast participants as Randomized/Transitioned (AAR) Population; participants with a Baseline value and a Week 52 value are included.||units on a scale||Standard Deviation|Mean
854270|NCT01285310|Secondary|Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 52|The Health Assessment Questionnaire - Disability Index (HAQ-DI) was a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 52|The Apremilast participants as Randomized/Transitioned (AAR) Population; participants with a Baseline value and a Week 52 value are included.||units on a scale||Standard Deviation|Mean
854271|NCT01285310|Secondary|Percentage of Participants With an American College of Rheumatology 20% Improvement (ACR 20) Response at Week 52|"Percentage of participants with an American College of Rheumatology 20% Improvement (ACR 20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:
≥ 20% improvement in 68 tender joint count;
≥ 20% improvement in 66 swollen joint count; and
≥ 20% improvement in at least 3 of the 5 following parameters: Subject's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Subject's global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Subject's self-assessment of physical function (Health Assessment Questionnaire - Disability Index ([HAQ-DI]); C-Reactive Protein."|Baseline and Week 52|"The Apremilast participants as Randomized/Transitioned (AAR) Population; participants with a Baseline value and a Week 52 value are included.
Reporting Groups"||percentage of participants||95% Confidence Interval|Number
854272|NCT01285310|Secondary|Percentage of Participants Who Achieve the European League Against Rheumatism (EULAR) Response Criteria Using CRP at Week 24|"EULAR response criteria classify each participant as a good, moderate or non-responder to treatment based on the degree of improvement from baseline and the level of disease activity at the endpoint. EULAR response is derived using the individual subject's DAS28 as the measure of severity of disease.
Good or moderate response is defined as follows: Good response: DAS28 at the time point ≤ 3.2 and improvement from baseline > 1.2 Moderate response: DAS28 at the time point > 3.2 and improvement from baseline > 1.2, or DAS28 at the time point ≤ 5.1 and improvement from baseline > 0.6 and ≤ 1.2"|Baseline and Week 24|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
854273|NCT01285310|Secondary|Percentage of Participants Who Achieve an Improvement of at Least 4 Units From Baseline in the Functional Assessment of Chronic Illness Therapy –Fatigue (FACIT-Fatigue) at Week 24|"The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue.
A positive change from baseline score indicates an improvement."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||percentage of participants|||Number
854274|NCT01285310|Secondary|Percentage of Participants Who Achieve an Improvement of ≥ 0.22 Units From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 24|The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
854275|NCT01285310|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 24|"The FACIT-Fatigue scale was a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue.
A positive change from baseline score indicates an improvement."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||units on a scale||Standard Error|Least Squares Mean
854276|NCT01285310|Secondary|Percentage Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 24|"The erythrocyte sedimentation rate (ESR) is a blood test that can reveal inflammatory activity. The subject's blood is placed in a tall, thin tube, red erythrocytes gradually settle to the bottom. Inflammation can cause the cells to clump together. Because these clumps of cells are denser than individual cells, they settle to the bottom more quickly.
The ESR test measures the distance red blood cells fall in a test tube in one hour. The farther the red blood cells have descended, the greater the inflammatory response."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||percent change||Standard Error|Least Squares Mean
854277|NCT01285310|Secondary|Percentage Change From Baseline in the High Sensitivity C-Reactive Protein (CRP) at Week 24|"C-Reactive Protein (CRP) is a substance produced by the liver that increases in the presence of inflammation in the body. An elevated CRP level is identified with blood tests and is considered a non-specific marker for disease."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||percent change||Standard Error|Least Squares Mean
854278|NCT01285310|Secondary|Percentage Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24|The Health Assessment Questionnaire - Disability Index (HAQ-DI) was a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||percent change||Standard Error|Least Squares Mean
854279|NCT01285310|Secondary|Percentage Change From Baseline in the Physician Global Assessment of Disease Activity at Week 24|"The Physician Global Assessment of Disease Activity was measured asking the physician to assess the subject's current arthritis disease activity by placing a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents  lowest disease activity, and the right-hand boundary (score = 100 mm) represents  highest disease activity. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||percent change||Standard Error|Least Squares Mean
854280|NCT01285310|Secondary|Percentage Change From Baseline in the Subject Global Assessment of Disease Activity at Week 24|"The Subject Global Assessment of Disease Activity was measured asking the participant to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents  lowest disease activity, and the right-hand boundary (score = 100 mm) represents  highest disease activity. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||percent change||Standard Error|Least Squares Mean
854281|NCT01285310|Secondary|Percentage Change From Baseline in the Subject Assessment of Pain at Week 24|"The Subject Assessment of Pain was measured asking the participant to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents no pain, and the right-hand boundary (score = 100 mm) represents pain as severe as can be imagined. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||percent change||Standard Error|Least Squares Mean
854282|NCT01285310|Secondary|Percentage Change From Baseline in the Swollen Joint Count at Week 24|Joint swelling is soft tissue swelling that is detectable along the joint margins and is assessed by inspection and direct palpation of the joint, by the examiner. The ACR 66 swollen joint count evaluates the following joints: upper-temporomandibular, sternoclavicular, acromioclavicular, shoulder, elbow, wrist, metacarpophalangeal, proximal interphalangeal and distal interphalangeal; lower: knee, ankle, midtarsal, metatarsophalangeal and proximal interphalangeal.|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||percent change||Standard Error|Least Squares Mean
854283|NCT01285310|Secondary|Percentage Change From Baseline in the Tender Joint Count at Week 24|Joint tenderness is the presence of pain in a joint when pressure is applied by the examiner to elicit tenderness. The 68 tender joint count evaluates the following joints: upper-temporomandibular, sternoclavicular, acromioclavicular, shoulder, elbow, wrist, meta-carpophalangeal, proximal interphalangeal and distal interphalangeal; lower: hip, knee, ankle, midtarsal, metatarsophalangeal and proximal interphalangeal.|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||percent change||Standard Error|Least Squares Mean
854284|NCT01285310|Secondary|Change From Baseline in Disease Activity Score 28 (DAS28) Using CRP at Week 24|"The DAS28 measures the severity of disease at a specific time and is derived from the following variables:
28 tender joint count
28 swollen joint count, which do not include the DIP joints, the hip joint, or the joints below the knee;
C-reactive protein (CRP)
Subject's Global Assessment of Disease Activity.
DAS28 values range from 2.0 to 10.0 while higher values mean a higher disease activity.
A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission."|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders. LOCF imputation was used.||units on a scale||Standard Error|Least Squares Mean
854285|NCT01285310|Secondary|Percentage of Participants Who Achieve Low Disease Activity or Remission Based on the Clinical Disease Activity Index (CDAI) ≤ 10 at Week 24|"The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:
28 tender joint count (TJC),
28 swollen joint count (SJC),
Subject’s Global Assessment of Disease Activity measured on a 100 mm visual analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest;
Physician's Global Assessment of Disease Activity -measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest.
The CDAI score ranges from 0-76 where lower scores indicate less disease activity.The following thresholds of disease activity have been defined for the CDAI:
Remission: ≤ 2.8; Low Disease Activity: > 2.8 and ≤ 10; Moderate Disease Activity: > 10 and ≤ 22; High Disease Activity: > 22"|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||percentage of participants|||Number
854286|NCT01285310|Secondary|Change From Baseline in the Clinical Disease Activity Index (CDAI) at Week 24|"The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:
28 tender joint count (TJC),
28 swollen joint count (SJC),
Subject’s Global Assessment of Disease Activity measured on a 100 mm visual analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest;
Physician's Global Assessment of Disease Activity -measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest.
The CDAI score ranges from 0-76 where lower scores indicate less disease activity.The following thresholds of disease activity have been defined for the CDAI:
Remission: ≤ 2.8; Low Disease Activity: > 2.8 and ≤ 10; Moderate Disease Activity: > 10 and ≤ 22; High Disease Activity: > 22"|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders. LOCF imputation was used.||units on a scale||Standard Error|Least Squares Mean
854287|NCT01285310|Secondary|Change From Baseline in the Medical Outcome Study Short Form 36-item (SF-36) Physical Functioning Domain at Week 24|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||units on a scale||Standard Error|Least Squares Mean
854288|NCT01285310|Secondary|Percentage of Participants With an American College of Rheumatology 70% Improvement (ACR 70) Response at Week 24|"Percentage of participants with an American College of Rheumatology 70% Improvement (ACR 70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:
≥ 70% improvement in 68 tender joint count;
≥ 70% improvement in 66 swollen joint count; and
≥ 70% improvement in at least 3 of the 5 following parameters:
Subject’s assessment of pain (measured on a 100 mm visual analog scale [VAS]); Subject’s global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Subject’s self-assessment of physical function (Health Assessment Questionnaire - Disability Index [(HAQ-DI)]); C-Reactive Protein."|Baseline and Week 24|Full Analysis Set = The FAS consisted of all participants who were randomized as specified per protocol during the placebo controlled period. The last observed joint assessment (at baseline or post-baseline) was used for joints unassessed at Week 24.||percentage of participants|||Number
854289|NCT01285310|Secondary|Percentage of Participants With an American College of Rheumatology 50% Improvement (ACR 50) Response at Week 24|"Percentage of participants with an American College of Rheumatology 50% Improvement (ACR 50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:
≥ 50% improvement in 68 tender joint count;
≥ 50% improvement in 66 swollen joint count; and
≥ 50% improvement in at least 3 of the 5 following parameters:
Subject’s assessment of pain (measured on a 100 mm visual analog scale [VAS]); Subject’s global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Subject’s self-assessment of physical function (Health Assessment Questionnaire - Disability Index [(HAQ-DI)]); C-Reactive Protein."|Baseline and Week 24|Full Analysis Set = The FAS consisted of all participants who were randomized as specified per protocol during the placebo controlled period. The last observed joint assessment (at baseline or post-baseline) was used for joints unassessed at Week 24.||percentage of participants|||Number
854290|NCT01285310|Secondary|Percentage of Participants With an American College of Rheumatology 70% Improvement (ACR 70) Response at Week 16|"Percentage of participants with an American College of Rheumatology 70% Improvement (ACR70) response. A participant was a responder if the following 3 criteria for improvement from baseline were met:
≥ 70% improvement in 68 tender joint count;
≥ 70% improvement in 66 swollen joint count; and
≥ 70% improvement in at least 3 of the 5 following parameters: Subject’s assessment of pain (measured on a 100 mm visual analog scale [VAS]); Subject’s global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Subject’s self-assessment of physical function (Health Assessment Questionnaire - Disability Index ([HAQ-DI]); C-Reactive Protein"|Baseline and Week 16|Full Analysis Set = The FAS consisted of all participants who were randomized as specified per protocol during the placebo controlled period. The last observed joint assessment (at baseline or post-baseline) was used for joints unassessed at Week 16.||percent of participants|||Number
854291|NCT01285310|Secondary|Percentage of Participants With an American College of Rheumatology 50% Improvement (ACR 50) Response at Week 16|"Percentage of participants with an American College of Rheumatology 50% Improvement (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:
≥ 50% improvement in 68 tender joint count;
≥ 50% improvement in 66 swollen joint count; and
≥ 50% improvement in at least 3 of the 5 following parameters:
Subject’s assessment of pain (measured on a 100 mm visual analog scale [VAS]); Subject’s global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Subject’s self-assessment of physical function (Health Assessment Questionnaire - Disability Index [(HAQ-DI)]); C-Reactive Protein."|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
854292|NCT01285310|Secondary|Percentage of Participants Who Achieve the European League Against Rheumatism (EULAR) Response Criteria Using CRP at Week 16|"EULAR response criteria classify each participant as a good, moderate or non-responder to treatment based on the degree of improvement from baseline and the level of disease activity at the endpoint. EULAR response is derived using the individual subject's DAS28 as the measure of severity of disease.
Good or moderate response is defined as follows: Good response: DAS28 at the time point ≤ 3.2 and improvement from baseline > 1.2 Moderate response: DAS28 at the time point > 3.2 and improvement from baseline > 1.2, or DAS28 at the time point ≤ 5.1 and improvement from baseline > 0.6 and ≤ 1.2"|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
854293|NCT01285310|Secondary|Percentage of Participants Who Achieve an Improvement of at Least 4 Units From Baseline in the Functional Assessment of Chronic Illness Therapy –Fatigue (FACIT-Fatigue) at Week 16|"The FACIT-Fatigue scale was a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue.
A positive change from baseline score indicates an improvement."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 16 are included; LOCF imputation was used.||percentage of participants|||Number
854294|NCT01285310|Secondary|Percentage of Participants Who Achieve an Improvement of ≥ 0.22 Units From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 16|The Health Assessment Questionnaire - Disability Index (HAQ-DI) was a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 16 are included; Last observation carried forward (LOCF) imputation was used.||percentage of participants|||Number
854295|NCT01285310|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 16|"The FACIT-Fatigue scale was a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue.
A positive change from baseline score indicates an improvement."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 16 are included. LOCF imputation was used.||units on a scale||Standard Error|Least Squares Mean
854296|NCT01285310|Secondary|Percentage Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 16|"The erythrocyte sedimentation rate (ESR) is a blood test that can reveal inflammatory activity. The subject’s blood is placed in a tall, thin tube, red erythrocytes gradually settle to the bottom. Inflammation can cause the cells to clump together. Because these clumps of cells are denser than individual cells, they settle to the bottom more quickly.
The ESR test measures the distance red blood cells fall in a test tube in one hour. The farther the red blood cells have descended, the greater the inflammatory response."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 16 are included; LOCF imputation was used.||percent change||Standard Error|Least Squares Mean
854297|NCT01285310|Secondary|Percentage Change From Baseline in the High Sensitivity C-Reactive Protein (CRP) at Week 16|"C-Reactive Protein (CRP) is a substance produced by the liver that increases in the presence of inflammation in the body. An elevated CRP level is identified with blood tests and is considered a non-specific marker for disease."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 16 are included; LOCF imputation was used.||percent change||Standard Error|Least Squares Mean
854298|NCT01285310|Secondary|Percentage Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 16|The Health Assessment Questionnaire - Disability Index (HAQ-DI) was a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 16 are included; LOCF imputation was used.||percent change||Standard Error|Least Squares Mean
854299|NCT01285310|Secondary|Percentage Change From Baseline in the Physician Global Assessment of Disease Activity at Week 16|"The Physician Global Assessment of Disease Activity was measured asking the physician to assess the subject’s current arthritis disease activity by placing a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents  lowest disease activity, and the right-hand boundary (score = 100 mm) represents  highest disease activity. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 16 are included; Last observation carried forward (LOCF) imputation was used.||percent change||Standard Error|Least Squares Mean
854300|NCT01285310|Secondary|Percentage Change From Baseline in the Subject Global Assessment of Disease Activity at Week 16|"The Subject Global Assessment of Disease Activity was measured asking the participant to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents  lowest disease activity, and the right-hand boundary (score = 100 mm) represents  highest disease activity. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 16 are included; LOCF imputation was used.||percent change||Standard Error|Least Squares Mean
854301|NCT01285310|Secondary|Percentage Change From Baseline in the Subject Assessment of Pain at Week 16|"The Subject Assessment of Pain was measured asking the participant to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents no pain, and the right-hand boundary (score = 100 mm) represents pain as severe as can be imagined. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 16 are included; LOCF imputation was used.||percent change||Standard Error|Least Squares Mean
854302|NCT01285310|Secondary|Percentage Change From Baseline in the Swollen Joint Count at Week 16|Joint swelling is soft tissue swelling that is detectable along the joint margins and is assessed by inspection and direct palpation of the joint, by the examiner. The ACR 66 swollen joint count evaluates the following joints: upper-temporomandibular, sternoclavicular, acromioclavicular, shoulder, elbow, wrist, metacarpophalangeal, proximal interphalangeal and distal interphalangeal; lower: knee, ankle, midtarsal, metatarsophalangeal and proximal interphalangeal.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 16 are included; LOCF imputation was used.||percent change||Standard Error|Least Squares Mean
854303|NCT01285310|Secondary|Percentage Change From Baseline in the Tender Joint Count at Week 16|Joint tenderness is the presence of pain in a joint when pressure is applied by the examiner to elicit tenderness. The 68 tender joint count evaluates the following joints: upper-temporomandibular, sternoclavicular, acromioclavicular, shoulder, elbow, wrist, meta-carpophalangeal, proximal interphalangeal and distal interphalangeal; lower: hip, knee, ankle, midtarsal, metatarsophalangeal and proximal interphalangeal.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 16 are included; LOCF imputation was used.||percent change||Standard Error|Least Squares Mean
854304|NCT01285310|Secondary|Change From Baseline in Disease Activity Score 28 (DAS28) (Using C-Reactive Protein) (CRP) at Week 16|"The DAS28 measures the severity of disease at a specific time and is derived from the following variables:
28 tender joint count (TJC28)
28 swollen joint count (SJC28), which do not include the distal interphalangeal (DIP) joints, the hip joint, or the joints below the knee;
C-reactive protein (CRP)
Subject’s global assessment of disease activity (SGA )
DAS28 values range from 2.0 to 10.0 while higher values mean a higher disease activity.
A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 16 are included. LOCF imputation was used.||units on a scale||Standard Error|Least Squares Mean
854305|NCT01285310|Secondary|Percentage of Participants Who Achieve Low Disease Activity or Remission Based on the Clinical Disease Activity Index (CDAI) ≤ 10 at Week 16|"The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:
28 tender joint count (TJC),
28 swollen joint count (SJC),
Subject’s Global Assessment of Disease Activity measured on a 100 mm visual analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest;
Physician's Global Assessment of Disease Activity -measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest.
The CDAI score ranges from 0-76 where lower scores indicate less disease activity. The following thresholds of disease activity have been defined for the CDAI:
Remission: ≤ 2.8; Low Disease Activity: > 2.8 and ≤ 10; Moderate Disease Activity: > 10 and ≤ 22; High Disease Activity: > 22"|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 16 are included. LOCF imputation was used.||percentage of participants|||Number
854306|NCT01285310|Secondary|Change From Baseline in the Clinical Disease Activity Index (CDAI) at Week 16|"The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:
28 tender joint count (TJC),
28 swollen joint count (SJC),
Subject’s Global Assessment of Disease Activity measured on a 100 mm visual analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest;
Physician's Global Assessment of Disease Activity -measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest.
The CDAI score ranges from 0-76 where lower scores indicate less disease activity. The following thresholds of disease activity have been defined for the CDAI:
Remission: ≤ 2.8; Low Disease Activity: > 2.8 and ≤ 10; Moderate Disease Activity: > 10 and ≤ 22; High Disease Activity: > 22"|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 16 are included. LOCF imputation was used.||units on a scale||Standard Deviation|Mean
854307|NCT01285310|Secondary|Change From Baseline in the Medical Outcome Study Short Form 36-item (SF-36) Physical Functioning Domain at Week 16|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The concepts measured by the SF-36 are not specific to any age, disease, or treatment group, allowing comparison of relative burden of different diseases and the relative benefit of different treatments. Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from baseline score indicates an improvement.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 16 are included; LOCF imputation was used.||units on a scale||Standard Deviation|Mean
854308|NCT01285310|Secondary|Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 24|The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||units on a scale||Standard Deviation|Mean
854309|NCT01285310|Secondary|Percentage of Participants With an American College of Rheumatology 20% Improvement (ACR 20) Response at Week 24|"Percentage of participants with an American College of Rheumatology 20% Improvement (ACR 20) response. A participant was a responder if the following 3 criteria for improvement from baseline were met:
≥ 20% improvement in 68 tender joint count;
≥ 20% improvement in 66 swollen joint count; and
≥ 20% improvement in at least 3 of the 5 following parameters: Subject’s assessment of pain (measured on a 100 mm visual analog scale [VAS]); Subject’s global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Subject’s self-assessment of physical function (Health Assessment Questionnaire - Disability Index ([HAQ-DI]); C-Reactive Protein"|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
854310|NCT01285310|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 16|The Health Assessment Questionnaire - Disability Index (HAQ-DI) was a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 16 are included; Last observation carried forward (LOCF) imputation was used.||units on a scale||Standard Deviation|Mean
854311|NCT01285310|Primary|Percentage of Participants With an American College of Rheumatology 20% Improvement (ACR 20) Response at Week 16|"Percentage of participants with an American College of Rheumatology 20% Improvement (ACR 20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:
≥ 20% improvement in 68 tender joint count;
≥ 20% improvement in 66 swollen joint count; and
≥ 20% improvement in at least 3 of the 5 following parameters: Subject’s assessment of pain (measured on a 100 mm visual analog scale [VAS]); Subject’s global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Subject’s self-assessment of physical function (Health Assessment Questionnaire - Disability Index ([HAQ-DI]); C-Reactive Protein."|Baseline and Week 16|Full analysis set consisting of all participants randomized as specified in the protocol; participants who were randomized in error and did not receive any dose of study drug were excluded. Participants who withdrew early or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
854463|NCT00932152|Secondary|To Evaluate Biomarkers (ERa, ERb, PR, VEGF and Aromatase Expression) in Baseline, Archival Tumor Tissue and Correlate Their Expression With Progression-free Survival, Time to Progression, and Overall Survival.||1.5 years|No data displayed because Outcome Measure has zero total participants analyzed.|||||
854464|NCT00932152|Secondary|To Evaluate the Levels of 17b-estradiol, VEGF, E-selectin, Thrombospondin-1 and IGF-1, and Other Biomarkers in the Plasma.||1.5 years|No data displayed because Outcome Measure has zero total participants analyzed.|||||
854465|NCT00932152|Secondary|To Evaluate the Time to Overall Survival, Time to Progression, and Toxicities||1.5 years|No data displayed because Outcome Measure has zero total participants analyzed.|||||
854466|NCT00932152|Primary|To Evaluate the Progression-free Survival.||1.5 years|Analysis was not completed because the trial was stopped prematurely due to slow accrual.|||||
854433|NCT01101880|Primary|Overall Survival|With 50 patients, the rates of these endpoints will be estimated with a standard error of 5 to 7 percentage points, depending on the observed rates.|Up to 5 years|||months||95% Confidence Interval|Median
854434|NCT01101880|Primary|Treatment-related Mortality (TRM)|Treatment-related mortality (TRM) data was not collected.|Up to 5 years|Treatment-related mortality (TRM) data was not collected.|||||
854435|NCT01101880|Primary|Event Free Survival|Number of patients in remission at a median follow up of 15 months.|Up to 5 years|||Participants|||Count of Participants
854436|NCT01101880|Primary|Time to Progression|With 50 patients, the rates of these endpoints will be estimated with a standard error of 5 to 7 percentage points, depending on the observed rates.|Up to 5 years|||weeks||Full Range|Median
854467|NCT00923351|Primary|Overall Survival|Overall survival is defined as the time between the first day of treatment to the day of death.|At time of patients death||02/2018||||
854438|NCT01101880|Primary|Rates of Complete Remission and Complete Remission With Incomplete Recovery of Counts|With 50 patients, the rates of these endpoints will be estimated with a standard error of 5 to 7 percentage points, depending on the observed rates. Complete remission is defined as less than 5% blast cells present in the bone marrow and count recovery (absolute neutrophil count greater than 1000/microL and platelet count greater than 100,000/microL). Complete remission with incomplete recovery of counts is defined as less than 5% blast cells present in the bone marrow without compete count recovery (absolute neutrophil count less than 1000/microL and platelet count less than 100,000/microL).|Up to 5 years|CR achieved with no AHD only applies to those who did not have AHD.||Participants|||Count of Participants
854446|NCT01079806|Secondary|Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormality (Grades 1-4) (Continued)|Toxicities graded per Division of AIDS criteria, Version 1.0, and modified World Health Organization criteria. ALT=alanine aminotransferase; AST=aspartate aminotransferase; BUN=blood urea nitrogen; ULN=upper limit of normal; LLN=lower limit of normal. ALT, AST (*ULN): Grade 1=1.25-2; Grade 2=2.6-5; Grade 3=5.1-10; Grade 4= >10. Bilirubin (*ULN): Grade 1=1.1-1.5; Grade 2=1.6-2.5; Grade 3=2.6-5; Grade 4= >5. Albumin (g/dL): Grade 1=3- <LLN; Grade 2=2-2.9; Grade 3= <2. Lipase (*ULN): Grade 1=1.1-1.5; Grade 2=1.6-3; Grade 3=3.1-5; Grade 4= >5. BUN/urea (*ULN): Grade 1=1.25-<2.6; Grade 2=2.6-<5.1; Grade 3=5.1-10; Grade 4= >10. Chloride, high (mEq/L): Grade 1=113-<117; Grade 2=117-<121; Grade 3=121-125; Grade 4= >125. Potassium, low (mEq/L): Grade 1=3-3.4; Grade 2=2.5-<3; Grade 3=2-<2.5; Grade 4=<2. Potassium, high (mEq/L): : Grade 1= 5.6-<6.1; Grade 2=6.1-<6.6; Grade 3=6.6-7; Grade 4= >7. Sodium, high (mEq/L): Grade 1=146<151; Grade 2=151-<155; Grade 3=155-<160; Grade 4= >=160.|Day 1 through Week 48 on blinded therapy|All randomized participants who received at least 1 dose of study medication; n=number of participants with laboratory results available||Participants|||Number
854447|NCT01079806|Secondary|Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormality (Grades 1-4)|Toxicities graded per Division of AIDS criteria, Version 1.0, and modified World Health Organization criteria. INR=international normalization ratio of prothrombin time; ULN=upper limit of normal. Hemoglobin (g/dL): Grade 1=10-10.9; Grade 2=9-9.9; Grade 3=7-8.9; Grade 4= <7. Platelets (/mm^3): Grade 1=100,000-124,999; Grade 2=50,000-99,999; Grade 3=25,000-49,999; Grade 4= <25,000. INR (*ULN): Grade 1=1.1-1.5; Grade 2=1.6-2; Grade 3=2.1-3; Grade 4= >3. WBC (/mm^3): Grade 1=2000-2500; Grade 2=1500-1999; Grade 3=1000-1499; Grade 4= <1000. Neutrophils (/mm^3): Grade 1=1000-1300; Grade 2=750-999; Grade 3=500-749; Grade 4= <500.|Day 1 through Week 48 on blinded therapy|All randomized participants who received at least 1 dose of study medication; n=number of participants with laboratory results available||Participants|||Number
854448|NCT01079806|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Related AEs, Grade 2-4 Related AEs, Grade 3-4 AEs, Malignancies, ALT Flares, and Hepatic Disease Progression|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or unknown relationship to study drug. Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death. ALT=alanine aminotransferase.|Day 1 through Week 48 on blinded therapy|All randomized participants who received at least 1 dose of study drug||Participants|||Number
854449|NCT01079806|Secondary|Percentage of Participants With Hepatitis B e (HBe) Seroconversion at Week 48|HBe seroconversion=undetectable HBe antigen and detectable anti-HBe antibodies. While the analysis of the primary endpoint was based on a randomized sample size of 123 participants (the Primary Cohort), the size of the overall study population was augmented to 180 randomized participants to meet global regulatory requirements.|At Week 48|The first 123 participants who were randomized and received treatment (referred to as the Primary Cohort)||Percentage of participants|||Number
854450|NCT01079806|Secondary|Percentage of Participants With Serum Alanine Aminotransferase ≤1*Upper Limit of Normal at Week 48|While the analysis of the primary endpoint was based on a randomized sample size of 123 participants (the Primary Cohort), the size of the overall study population was augmented to 180 randomized participants to meet global regulatory requirements.|At Week 48|The first 123 participants who were randomized and received treatment (referred to as the Primary Cohort)||Percentage of participants|||Number
854451|NCT01079806|Secondary|Percentage of Participants With Hepatitis B Virus DNA <Limit of Quantitation (LOQ) at Week 48|LOQ=29 IU/mL. While the analysis of the primary endpoint was based on a randomized sample size of 123 participants (the Primary Cohort), the size of the overall study population was augmented to 180 randomized participants to meet global regulatory requirements.|At Week 48|The first 123 participants who were randomized and received treatment (referred to as the Primary Cohort)||Percentage of participants|||Number
854452|NCT01079806|Secondary|Percentage of Participants With Hepatitis B Virus (HBV) DNA <50 IU/mL at Week 48|While the analysis of the primary endpoint was based on a randomized sample size of 123 participants (the Primary Cohort), the size of the overall study population was augmented to 180 randomized participants to meet global regulatory requirements.|At Week 48|The first 123 participants who were randomized and received treatment (referred to as the Primary Cohort)||Percentage of participants|||Number
854453|NCT01079806|Primary|Percentage of Participants Who Achieved a Combination of Hepatitis B Virus (HBV) DNA Suppression and Hepatitis B e Antigen (HBeAg) Seroconversion at Week 48|Suppression=HBV DNA<50 IU/mL (approximately 300 copies/mL) using the Roche COBAS TaqMan HBV Test for use with the High Pure System assay; seroconversion=undetectable HBeAg and detectable anti-hepatitis B e antibodies. While the analysis of the primary endpoint was based on a randomized sample size of 123 participants (the Primary Cohort), the size of the overall study population was augmented to 180 randomized participants to meet global regulatory requirements.|At Week 48|The first 123 participants who were randomized and received treatment (referred to as the Primary Cohort)||Percentage of participants|||Number
854454|NCT01062425|Secondary|Incidence of Grade 3+ Toxicities|The number of patients with reported grade 3 and higher treatment-related toxicities as assessed by Common Terminology Criteria for Adverse Events version 4.0|From randomization to six months.|All randomized and eligible patients who started protocol treatment.||participants|||Number
854455|NCT01062425|Secondary|Progression-free Survival (PFS)|Progression-free survival time is defined as time from randomization to date of first progression or death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive without progression are censored at the date of last contact. Progression is defined as any of the following: ≥ 25% increase in sum of the products of perpendicular diameters of enhancing lesions; any new lesion; or clinical deterioration.|From randomization to time of first progression or death due to any cause. Patients are followed until death. Analysis occurs after all patients have been potentially followed for six months.|All randomized and eligible patients.||Months||95% Confidence Interval|Median
854456|NCT01062425|Secondary|Overall Survival (OS)|OS will be estimated using the Kaplan-Meier method and differences between treatment arms will be tested using the log rank test. Multivariate analyses with the Cox proportional hazard model for OS will be performed with the stratification variables as fixed variables to assess the treatment effect adjusting patient-specific risk factors.|From randomization to time of death due to any cause. Patients are followed until death. Analysis occurs after all patients have been potentially followed for six months.|All randomized and eligible patients.||Months||95% Confidence Interval|Median
854457|NCT01062425|Primary|6-month Progression-free Survival Rate|Six-month progression-free survival is the rate of patients who have NOT progressed at six months, where progressive disease is defined as any of the following: ≥ 25% increase in sum of the products of perpendicular diameters of enhancing lesions; any new lesion; or clinical deterioration. Progression will be determined by central review of MRI exams, assessed using MacDonald criteria for progression versus response on 2D T1 and T2 weighted images.|From randomization to 6 months.|Randomized eligible patients with evaluable data at six months. (From the randomized eligible patients, 2 patients withdrew prior to 6 months and 1 did not have an evaluable scan on the placebo arm, while 4 withdrew before 6 months, 3 did not have an evaluable scan, and 2 did not receive protocol treatment on the cediranib arm.)||percentage of participants||95% Confidence Interval|Number
854469|NCT00923351|Primary|Number of Participants With a Positive Immune Response as Evidenced by the Delayed Type of Hypersensitivity (DTH) Reaction Assay|"A positive response to the tumor vaccine requires a positive reaction in at least one of the two assays below (immune responses to tumor lysates using ex vivo and delayed type of hypersensitivity (DTH).
The presence of a positive delayed type of hypersensitivity (DTH) reaction to the tumor lysate in a patient who did not show a positive DTH reaction prior to immunotherapy. A positive reaction is induration of at least 0.5 cm.
Immunotherapy administered to patients with recurrent or metastatic pediatric solid tumors such as Ewing's sarcoma, rhabdomyosarcoma, or neuroblastoma. Each vaccine is given as 6 separate injections. Three intradermal on one arm or leg and three subcutaneous on the other arm or leg."|Week 8, 14, 20 (Arm A) and on Days 42, 84 and 126 (± 7 days) (Arm B)|Five of the original six participants from Arm A were analyzed because one subject was changed to a special exemption.||Participants|||Count of Participants
854470|NCT00920439|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Day 0 to Month 1)|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with documented administration of the study vaccine.||Subjects|||Number
854471|NCT00920439|Primary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 31-day (Days 0-30) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with documented administration of the study vaccine.||Subjects|||Number
854472|NCT00920439|Primary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were temperature [defined as axillary temperature equal to or above (≥) 37.1 degrees Celsius (°C)], drowsiness, irritability and loss of appetite. Any = all reports of the specified symptom irrespective of intensity grade and relationship to vaccination. Grade 3 drowsiness= drowsiness that prevented normal activity. Grade 3 irritability= crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite= subject did not eat at all. Grade 3 fever = fever above (>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with documented administration of the study vaccine.||Subjects|||Number
854473|NCT00920439|Primary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = all reports of the specified symptom irrespective of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with documented administration of the study vaccine.||Subjects|||Number
854474|NCT00912509|Secondary|Time to Resolution of Stromal Infiltration||day 1, day 2, day 3, day 4, day 5, day 6, day 7, week 2, week 3 (weekly assessment) until infiltrate is completely resolved|||days||Inter-Quartile Range|Median
854475|NCT00912509|Primary|Time to Re-epithelialization||Day 1, Day 2, Day 3, (daily assessment) after study treatment until re-epithelialization is complete|||Days||Inter-Quartile Range|Median
854525|NCT00689936|Secondary|Improvement of Infection Rate by Observing the Historical Data Compared to the Clinical Data Base|Improvement of infection rate by observing historical data compared to the data within clinical database as not analyzed.|From randomization to 24 May 2013||||||
854772|NCT02105324|Secondary|Mean Nausea Index Score Using a Visual Analogue Scale (VAS)|Participants rated their nausea using a 0 to 10 centimeter (cm) VAS where 0=least severe nausea to 10=most severe nausea. The average nausea index scores from Day 1 to Day 5 were calculated|Day 1, Days 1-5, and Days 2-5 in each period|All randomized participants who completed both periods of the study.||cm||Standard Deviation|Mean
854526|NCT00689936|Secondary|Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase.|Improvement in platelets was assessed for participants from baseline grade to most extreme severity grade using the NCI CTCAE v 3.0 grading scale.|Randomization to end of treatment or the data cut off of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm|Safety population; Includes participants with baseline and postbaseline platelet laboratory test grade information||participants|||Number
854527|NCT00689936|Secondary|Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase|Hemoglobin was assessed for participants from baseline grade to most extreme severity grade using the NCI CTCAE v 3.0 grading scale.|Randomization to end of treatment or the data cut off of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm|Safety Population; Includes participants with baseline and postbaseline hemoglobin laboratory test grade information||participants|||Number
854528|NCT00689936|Secondary|Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase|Neutrophil counts was assessed for participants from baseline grade to most extreme severity grade using the NCI CTCAE v 3.0 grading scale.|Randomization to end of treatment or the data cut off of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm|Safety Population; includes participants with baseline and postbaseline absolute neutrophil laboratory test grade information||participants|||Number
854529|NCT00689936|Secondary|Shift From Baseline to Most Extreme Postbaseline Value in Creatinine Clearance (CrCl) During the Active Treatment Phase|Renal function was assessed for participants from baseline to the most extreme value in creatinine clearance calculated using the Cockcroft-Gault estimation.|Randomization to end of treatment or the data cut off of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm|Safety Population with baseline and postbaseline CrCl data.||participants|||Number
854530|NCT00689936|Secondary|Number of Participants With Adverse Events (AEs) During the Active Treatment Phase|A TEAE is any AE occurring or worsening on or after the first treatment of any study drug, and within 30 days after the last dose of the last study drug. Severity grades according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE) on a 1-5 scale: Grade 1= Mild AE, Grade 2= Moderate AE, Grade 3= Severe AE, Grade 4= Life-threatening or disabling AE, Grade 5=Death related to AE. A serious AE is any AE occurring at any dose that: • Results in death; • Is life-threatening; • Requires or prolongs existing inpatient hospitalization; • Results in persistent or significant disability/incapacity; • Is a congenital anomaly/birth defect; • Constitutes an important medical event.|From first dose of study drug through 28 days following the discontinuation visit from active treatment phase; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm|Safety population included all participants who received at least one dose treatment dose of treatment in any arm||Participants|||Number
854531|NCT00689936|Secondary|Healthcare Resource Utilization (HRU): Rate of Inpatient Hospitalizations Per Year|HRU was defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient. HRU Analysis may help in evaluating potential costs and budget impact of new treatments from a payer perspective. The rate of inpatient hospitalizations per patient year was calculated as the total number of hospitalizations divided by the total number of patient-years followed in the study period. Patient-years (PY) were calculated as the duration from baseline to last available HRQL assessment for each patient.|Day 1 (randomization) up to last visit completed 25 July 2016|Healthcare Resource Utilization not analyzed.|||||
854532|NCT00689936|Secondary|Change From Baseline in the European Quality of Life-5 Dimensions (EQ-5D) Health Utility Index Score|EQ-5D is a self-administered questionnaire that assesses health-related quality of life. The EQ-5D descriptive health profile comprises five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension has 3 levels of response: No problem (1), some problems (2), and extreme problems (3). A unique EQ-5D health state is defined by combining one level from each of the five dimensions into a single utility index score. EQ-5D index values range from -0.59 to 1.00 where higher EQ-5D scores represent better health status. A positive change from baseline score indicates improvement in health status and better health state.|Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit|ITT population with available data.||units on a scale||Standard Deviation|Mean
854533|NCT00689936|Secondary|Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Body Image Scale|EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used a 4-point scale (from 1 'Not at All' to 4 'Very Much'). Scores were averaged, and transformed to a 0-100 scale; for the body image scale, a higher score indicates a better body image.|Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit|ITT population with available data.||units on a scale||Standard Deviation|Mean
854534|NCT00689936|Secondary|Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Future Perspective Scale|EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used a 4-point scale (from 1 'Not at All' to 4 'Very Much'). Scores were averaged, and transformed to a 0-100 scale; for the future perspective scale, a higher score indicates a better perspective of the future.|Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit|ITT population with available data.||units on a scale||Standard Deviation|Mean
854535|NCT00689936|Secondary|Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Side Effects Treatment Scale|EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used a 4-point scale (from 1 'Not at All' to 4 'Very Much'). Scores were averaged, and transformed to a 0-100 scale; a higher score represents a more severe overall side effect of treatment.|Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit|ITT population with available data.||units on a scale||Standard Deviation|Mean
854536|NCT00689936|Secondary|Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale|EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used a 4-point scale (from 1 'Not at All' to 4 'Very Much'). Scores were averaged, and transformed to a 0-100 scale; a higher score indicates more severe disease symptom(s).|Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit|ITT population with available data.||units on a scale||Standard Deviation|Mean
854537|NCT00689936|Secondary|Change From Baseline in the EORTC QLQ-C30 Financial Difficulties Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Financial Difficulties Scale is scored between 0 and 100, with a high score indicating a higher level of financial difficulties. Negative change from Baseline values indicate improvement in financial difficulties and positive values indicate worsening of financial difficulties.|Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit|ITT population with available data.||units on a scale||Standard Deviation|Mean
854538|NCT00689936|Secondary|Change From Baseline in the EORTC QLQ-C30 Diarrhea Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Diarrhea Scale is scored between 0 and 100, with a high score indicating a higher level of diarrhea. Negative change from Baseline values indicate improvement in diarrhea and positive values indicate worsening of diarrhea.|Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit|ITT population with available data.||units on a scale||Standard Deviation|Mean
854539|NCT00689936|Secondary|Change From Baseline in the EORTC QLQ-C30 Constipation Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Constipation Scale is scored between 0 and 100, with a high score indicating a higher level of constipation. Negative change from Baseline values indicate improvement in constipation and positive values indicate worsening of constipation.|Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit|ITT population with available data.||units on a scale||Standard Deviation|Mean
854540|NCT00689936|Secondary|Change From Baseline in the EORTC QLQ-C30 Appetite Loss Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Appetite Loss Scale is scored between 0 and 100, with a high score indicating a higher level of appetite loss. Negative change from Baseline values indicate improvement in appetite and positive values indicate worsening of appetite.|Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit|ITT population with available data.||units on a scale||Standard Deviation|Mean
854541|NCT00689936|Secondary|Change From Baseline in the EORTC QLQ-C30 Insomnia Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Insomnia Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms.|Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit|Intent to Treat (ITT) population with available data.||units on a scale||Standard Deviation|Mean
854542|NCT00689936|Secondary|Change From Baseline in the EORTC QLQ-C30 Dyspnea Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Dyspnoea Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms.|Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit|ITT population includes all participants with available data.||units on a scale||Standard Deviation|Mean
854574|NCT00674583|Secondary|Number of Subjects Between 2 and 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms assessed were drowsiness, fever [defined as oral temperature ≥ 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the general symptom regardless of intensity grade and relationship to vaccination. Grade 3 Symptom = symptom that prevented normal activity. Grade 3 Loss of appetite = did not eat at all. Grade 3 Fever = fever > 39.5°C. Related = general symptoms assessed by the investigator as causally related to vaccination|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with their symptom sheets filled in, for whom data were available.||Participants|||Count of Participants
854543|NCT00689936|Secondary|Change From Baseline in the EORTC QLQ-C30 Nausea/Vomiting Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Nausea/Vomiting Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms.|Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit|Intent to Treat (ITT) population with available data.||units on a scale||Standard Deviation|Mean
854544|NCT00689936|Secondary|Change From Baseline in the EORTC QLQ-C30 Pain Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Pain Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms.|Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit|Intent to Treat (ITT) population with available data.||units on a scale||Standard Deviation|Mean
854545|NCT00689936|Secondary|Change From Baseline in the EORTC QLQ-C30 Fatigue Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms.|Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation|Intent to Treat (ITT) population with available data.||units on a scale||Standard Deviation|Mean
854546|NCT00689936|Secondary|Change From Baseline in the EORTC QLQ-C30 Social Functioning Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Social Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.|Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit|Intent to Treat (ITT) population with available data.||units on a scale||Standard Deviation|Mean
854547|NCT00689936|Secondary|Change From Baseline in the EORTC QLQ-C30 Cognitive Functioning Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Cognitive Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.|Cycle 1 Day 1, (Baseline) then Months 1, 3, 6, 12, 18 and Discontinuation visit|Intent to Treat (ITT) population with available data.||units on a scale||Standard Deviation|Mean
854548|NCT00689936|Secondary|Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Emotional Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.|Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit|Intent to Treat (ITT) population with available data.||units on a scale||Standard Deviation|Mean
854549|NCT00689936|Secondary|Change From Baseline in the EORTC QLQ-C30 Role Functioning Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Role Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.|Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit|Intent to Treat (ITT) population with available data.||units on a scale||Standard Deviation|Mean
854575|NCT00674583|Secondary|Number of Subjects Between 6 and 10 Years of Age With Any and Grade 3 Solicited Local Symptoms|Solicited symptoms assessed were: pain, redness and swelling. Any = occurrence of any local symptom regardless of their intensity grade. Grade 3 Pain = pain that prevented normal activity. Grade 3 Redness and Swelling= redness/swelling spreading beyond (>) 50 millimeters (mm).|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with their symptom sheets filled in, for whom data were available.||Participants|||Count of Participants
854550|NCT00689936|Secondary|Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Physical Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.|Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit|Intent to Treat (ITT) population with available data.||units on a scale||Standard Deviation|Mean
854551|NCT00689936|Secondary|Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Health Status Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status/QOL scale is scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in QOL or functioning and positive values indicate improvement.|Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit|Intent to Treat (ITT) population with available data.||units on a scale||Standard Deviation|Mean
854552|NCT00689936|Secondary|Percentage of Participants With a Myeloma Response by Uncertain Risk Cytogenetic Risk Category Based on IRAC Review|Participants were placed in adverse and non-adverse cytogenetic risk categories at baseline and response rates evaluated. Adverse Risk: t(4;14), t(14;16), del(13q) or monosomy 13, del(17p), 1q gain Favorable Hyperdiploidy: : t(11;14), gains of 5/9/15; Normal: a normal result, gains other than 5/9/15, IgH deletion Uncertain risk: probes used for analysis cannot place participant in any of the other risk categories. Objective response = best overall response including CR, VGPR or PR based on the IRAC Review; A CR is negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPRis serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas.|Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm|ITT population with a Cytogenetic Risk of Uncertain Risk||percentage of participants|||Number
854553|NCT00689936|Secondary|Percentage of Participants With a Myeloma Response by Normal Risk Cytogenetic Risk Category Based on IRAC Review|Participants were placed in adverse and non-adverse cytogenetic risk categories at baseline and response rates evaluated. Adverse Risk: t(4;14), t(14;16), del(13q) or monosomy 13, del(17p), 1q gain Favorable Hyperdiploidy: : t(11;14), gains of 5/9/15; Normal: a normal result, gains other than 5/9/15, IgH deletion Uncertain risk: probes used for analysis cannot place participant in any of the other risk categories. Objective response = best overall response including CR, VGPR or PR based on the IRAC Review; A CR is negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPRis serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas.|Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm|ITT population with a cytogenetic risk of normal||percentage of particpants|||Number
854554|NCT00689936|Secondary|Percentage of Participants With a Myeloma Response by Favorable Hyperdiploidy Risk Cytogenetic Risk Category Based on IRAC Review|Participants were placed in adverse and non-adverse cytogenetic risk categories at baseline and response rates evaluated. Adverse Risk: t(4;14), t(14;16), del(13q) or monosomy 13, del(17p), 1q gain Favorable Hyperdiploidy: : t(11;14), gains of 5/9/15; Normal: a normal result, gains other than 5/9/15, IgH deletion Uncertain risk: probes used for analysis cannot place participant in any of the other risk categories. Objective response = best overall response including CR, VGPR or PR based on the IRAC Review; A CR is negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPRis serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas.|Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm|ITT population with a Cytogenetic Risk of Favorable Hyperploidy||percentage of participants|||Number
854565|NCT00689936|Secondary|Percentage of Participants With an Objective Response Based on Investigator Assessment at Time of Final Analysis|Objective response according to IMWG Uniform Response Criteria was defined as a best overall response including a complete response (CR), very good partial response (VGPR) or partial response (PR) based on the IRAC Review. A CR is defined s: negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPR is serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is: ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas.|Disease response was assessed every 28 days until end of treatment or the data cut-off date of 21 January 2016; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm|ITT population includes all participants who were randomized, independent of whether they received study treatment or not.||percentage of participants|||Number
854555|NCT00689936|Secondary|Percentage of Participants With a Myeloma Response by Adverse Risk Cytogenetic Risk Category Based on IRAC Review.|Participants were placed in adverse and non-adverse cytogenetic risk categories at baseline and response rates evaluated. Adverse Risk: t(4;14), t(14;16), del(13q) or monosomy 13, del(17p), 1q gain Favorable Hyperdiploidy: : t(11;14), gains of 5/9/15; Normal: a normal result, gains other than 5/9/15, IgH deletion Uncertain risk: probes used for analysis cannot place participant in any of the other risk categories. Objective response = best overall response including CR, VGPR or PR based on the IRAC Review; A CR is negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPRis serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas.|Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm|ITT population with Cytogenetic risk of Adverse Risk||Percentage of participants|||Number
854556|NCT00689936|Secondary|Percentage of Participants With an Objective Response After Second-line Anti-myeloma Treatment at the Time of Final Analysis|Objective response according to IMWG Uniform Response Criteria was defined as a best overall response including a complete response (CR), very good partial response (VGPR) or partial response (PR) based on the IRAC Review. A CR is defined s: negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPR is serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is: ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas.|Disease response was assessed every 28 days until end of treatment; data cut-off date of 21 January 2016; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm|ITT population; Participants with second line AMT.||percentage of participants|||Number
854557|NCT00689936|Secondary|Kaplan Meier Estimates of Time to Second Line Therapy AMT at the Time of Final Analysis|Time to second-line anti-myeloma therapy is defined as time from randomization to the start of another non-protocol anti-myeloma therapy. Those who do not receive another anti-myeloma therapy were censored at the last assessment or follow-up visit known to have received no new therapy.|From date of randomization until the data cut-off of date 21 January 2016; median follow-up for all participants was 23.0 months|ITT population includes all participants who were randomized, independent of whether they received study treatment or not.||months||Full Range|Median
854558|NCT00689936|Secondary|Kaplan Meier Estimates for Time to Second-line Anti-myeloma Treatment (AMT)|Time to second-line anti-myeloma therapy was defined as time from randomization to the start of another non-protocol anti-myeloma therapy.|From date of randomization until the data cut-off of 24 May 2013; median follow-up for all participants was 23.0 months|ITT population includes all participants who were randomized, independent of whether they received study treatment or not||months||95% Confidence Interval|Median
854559|NCT00689936|Secondary|Kaplan Meier Estimates of Time to Treatment Failure (TTF) at the Time of Final Analysis|TTF is defined as the time between the randomization and discontinuation of study treatment for any reason, including disease progression (determined by the investigators assessment based on the IMWG response criteria), treatment toxicity, start of another anti-myeloma therapy (AMT) or death.|From date of randomization until the data cut-off date of 21 January 2016; median follow up for all participants was 16.1 months.|ITT population includes participants who were randomized, independent of whether they received study treatment or not||months||95% Confidence Interval|Median
854560|NCT00689936|Secondary|Kaplan Meier Estimates of Time to Treatment Failure (TTF)|TTF is defined as the time between the randomization and discontinuation of study treatment for any reason, including disease progression (determined by IRAC based on the IMWG response criteria), treatment toxicity, start of another anti-myeloma therapy (AMT) or death.|From date of randomization until the data cut-off of 24 May 2013; median follow-up for all participants was 16.1 months.|ITT population includes participants who were randomized, independent of whether they received study treatment or not||months||95% Confidence Interval|Median
854561|NCT00689936|Secondary|Time to First Response Based on the Investigator Assessment at the Time of Final Analysis|The time to first myeloma response was defined as the time from randomization to the time when the response criteria for at least a PR was first met based on the IMWG criteria assessed by the investigator.|Disease response was assessed every 28 days until end of treatment or the data cut-off date of 21 January 2016; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm.|Participants who had at least a PR.||months||Full Range|Median
854562|NCT00689936|Secondary|Time to First Response Based on the Review by the IRAC|The time to first myeloma response was defined as the time from randomization to the time when the response criteria for at least a PR was first met based on the IMWG criteria.|Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm|Participants who had at least a PR.||months||Full Range|Median
854563|NCT00689936|Secondary|Kaplan Meier Estimates of Duration of Myeloma Response as Determined by an Investigator Assessment at Time of Final Analysis|Duration of response was defined as the duration from the time when the response criteria were first met for CR or VGPR or PR based on IMWG criteria until the first date the response criteria were met for progressive disease or until the participant died from any cause, whichever occurred first.|Disease response was assessed every 28 days until end of treatment; data cut-off date of 21 January 2016; median follow-up for responders was 19.9 months|Study participants with at least a PR||months||95% Confidence Interval|Median
854564|NCT00689936|Secondary|Kaplan Meier Estimates of Duration of Myeloma Response as Determined by the IRAC|Duration of response was defined as the duration from the time when the response criteria were first met for CR or VGPR or PR based on IMWG criteria until the first date the response criteria were met for progressive disease or until the participant died from any cause, whichever occurred first.|Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median follow-up for responders was 20.1 months|Study participants with at least a PR||months||95% Confidence Interval|Median
854566|NCT00689936|Secondary|Percentage of Participants With an Objective Response Based on IRAC Review|Objective response according to IMWG Uniform Response Criteria was defined as a best overall response including a complete response (CR), very good partial response (VGPR) or partial response (PR) based on the IRAC Review. A CR is defined as: negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPR is serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is: ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas.|Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm|ITT population includes all participants who were randomized, independent of whether they received study treatment or not.||percentage of participants|||Number
854567|NCT00689936|Secondary|Kaplan Meier Estimates of Overall Survival at the Time of Final Analysis (OS)|Overall survival was defined as the time between randomization and death. Participants, who died, regardless of the cause of death, were considered to have had an event. All participants who were lost to follow-up prior to the end of the trial or who were withdrawn from the trial were censored at the time of last contact. Participants who were still being treated were censored at the last available date the participant was known to be alive.|From date of randomization to date of data cut-off date of 21 January 2016; median follow-up for all participants was 48.3 months|ITT population included all participants who were randomized, independent of whether they received study treatment or not.||months||95% Confidence Interval|Median
854568|NCT00689936|Primary|Kaplan-Meier Estimates of PFS Based on the Response Assessment by the Investigator At the Time of Final Analysis|PFS was calculated as the time from randomization to the first documented PD or death due to any cause during the study, which ever occurred first based on the International Myeloma Working Group Uniform Response criteria (IMWG). Those who withdrew for any reason or received another anti-myeloma therapy without documented PD were censored on the date of their last response assessment, prior to receiving any other anti-myeloma therapy. Censoring rules for PFS: - No baseline assessments and no progression or death documented within the 2 scheduled assessments; Death within the lst two assessments without any adequate response assessment; Progression documented between scheduled assessments; Death between adequate assessments; no progression; study discontinuations for reasons other than PD or death; new anti-myeloma started prior to PD; death or PD after an extended lost to follow-up time period (2 or more missed scheduled assessment's).|From date of randomization to date of data cut-off date of 21 January 2016; median follow-up for all participants was 17.7 months|The intent to treat population included all participants who were randomized, independent of whether they received study treatment or not.||months||95% Confidence Interval|Median
854569|NCT00689936|Primary|Kaplan-Meier Estimates of Progression-free Survival (PFS) Based on the Response Assessment by the Independent Review Adjudication Committee (IRAC)|PFS was calculated as the time from randomization to the first documented PD or death due to any cause during the study, which ever occurred first based on the International Myeloma Working Group Uniform Response criteria (IMWG). Those who withdrew for any reason or received another anti-myeloma therapy without documented PD were censored on the date of their last response assessment, prior to receiving any other anti-myeloma therapy. Censoring rules for PFS: - No baseline assessments and no progression or death documented within the 2 scheduled assessments; Death within the lst two assessments without any adequate response assessment; Progression documented between scheduled assessments; Death between adequate assessments; no progression; study discontinuations for reasons other than PD or death; new anti-myeloma started prior to PD; death or PD after an extended lost to follow-up time period (2 or more missed scheduled assessment's).|From date of randomization until the data cut-off date of 24 May 2013. Median follow-up time for all participants was 17.1 months.|The intent to treat (ITT) population included all participants who were randomized, independent of whether they received study treatment or not.||months||95% Confidence Interval|Median
854570|NCT00674583|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Up to six months after vaccination (Month 6)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Participants|||Count of Participants
854571|NCT00674583|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Days 0-30) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Participants|||Count of Participants
854572|NCT00674583|Secondary|Number of Subjects Reporting Specific Adverse Events|"Specific AEs included:
rash (hives, idiopathic thrombocytopenic purpura, petechiae);
new onset of chronic illness(es) (NOCI) (e.g. autoimmune disorders, asthma, type I diabetes and allergies);
conditions prompting emergency room (ER) visits."|Up to 6 months after vaccination (Month 6)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Participants|||Count of Participants
854573|NCT00674583|Secondary|Number of Subjects Between 6 and 10 Years of Age With Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms assessed were drowsiness, fever [defined as oral temperature ≥ 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the general symptom regardless of intensity grade and relationship to vaccination. Grade 3 Symptom = symptom that prevented normal activity. Grade 3 Loss of appetite = did not eat at all. Grade 3 Fever = fever > 39.5°C. Related = general symptoms assessed by the investigator as causally related to vaccination|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with their symptom sheets filled in, for whom data were available.||Participants|||Count of Participants
854576|NCT00674583|Secondary|Number of Subjects Between 2 and 5 Years of Age With Any and Grade 3 Solicited Local Symptoms|Solicited symptoms assessed were: pain, redness and swelling. Any = occurrence of any local symptom regardless of their intensity grade. Grade 3 Pain = cried when limb was moved/spontaneously painful. Grade 3 Redness and Swelling= redness/swelling spreading beyond (>) 30 millimeters (mm).|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with their symptom sheets filled in, for whom data were available.||Participants|||Count of Participants
854577|NCT00674583|Secondary|Anti-meningococcal Serogroup Polysaccharides (Anti-PS) Antibody Concentrations|Anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY antibody concentrations were presented as geometric mean concentrations (GMCs) and tabulated as micrograms per milliliter (μg/mL).|Prior to (Month 0) and one month after vaccination (Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.||μg/mL||95% Confidence Interval|Geometric Mean
854578|NCT00674583|Secondary|Meningococcal Serogroup A (rSBA) Antibody Titers|Antibody titers were presented as geometric mean titers (GMTs).|Prior to (Month 0) and one month after vaccination (Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.||Titers||95% Confidence Interval|Geometric Mean
854579|NCT00674583|Primary|Number of Subjects With Vaccine Response to Meningococcal Serogroup C Serum Based on a Bactericidal Assay Using Baby Rabbit Complement (rSBA-MenC) Antibody|"Vaccine response to MenC was defined as:
for initially seronegative subjects [i.e. rSBA-MenC titer below (<) 1:8], antibody titer greater than or equal to (≥) 1:32;
for initially seropositive (i.e. rSBA-MenC titer ≥ 1:8), antibody titer post-vaccination ≥ 4-fold the pre-vaccination antibody titer."|One month after vaccination (Month 1)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.||Participants|||Count of Participants
854580|NCT00651794|Secondary|Neonatal Resuscitation Program (NRP) Quality as Assessed by Resuscitation Duration|Resuscitation duration is time required to complete the resuscitation. The total duration for each resuscitation was calculated from the start of the instructor’s reading of the scenario to the team’s statement that the infant should be transferred to the NICU. When any teaching moments occurred during the simulation, the total teaching time was subtracted from the resuscitation duration.|During the megacode, which was performed about 1 hour after the training|||seconds||Standard Deviation|Mean
854581|NCT00651794|Secondary|Neonatal Resuscitation Program (NRP) Quality as Assessed by NRP Performance Score|We analyzed 2 measures of NRP quality: performance score and resuscitation duration. The performance score was calculated by averaging the scores (ranging from 0 to 2 - higher values represent a better outcome) for each NRP step (some of which occurred multiple times). Those scores were summed and divided by the total possible score (2 times the number of steps that should have been performed). When a step was not indicated for the specific resuscitation scenario (e.g., meconium aspiration), that step was not scored by the observers and it was not included in the denominator for performance calculation. This produced a measure of performance percentage ranging from 0 percent to 100 percent (higher values represent a better outcome) for each resuscitation.|During the megacode, which was performed about 1 hour after the training|||performance percentage||Standard Deviation|Mean
854582|NCT00651794|Secondary|Percentage of Time Spent on Vigilance|Vigilance percentage was calculated by summing the total time the team demonstrated vigilance behavior and dividing by the total resuscitation time.|During the megacode, which was performed about 1 hour after the training|||percentage of time||Standard Deviation|Mean
854583|NCT00651794|Secondary|Percentage of Time Spent on Workload Management|Workload management percentage was calculated by summing the total time the team demonstrated workload management behavior and dividing by the total resuscitation time.|During the megacode, which was performed about 1 hour after the training|||percentage of time||Standard Deviation|Mean
854584|NCT00651794|Primary|Teamwork Event Rate|The teamwork event rate was calculated by summing the number of scored teamwork events (sharing information, inquiry, assertion, teaching/advising, and evaluation of plans) and dividing by the total resuscitation time (in minutes).|During the megacode, which was performed about 1 hour after the training|||teamwork events per minute||Standard Deviation|Mean
854634|NCT00424047|Post-Hoc|Kaplan-Meier Estimate of Duration of Response (Cut-off at a Later Date of 03 March 2008)|Duration of response was calculated for responders and defined as the time from the first observation of a response (e.g., the first time that the appropriate decrease in M-protein level was observed for confirmed responders) to the first documented progression or relapse. Response duration was censored at the last adequate assessment showing evidence of no progression.|Up to data cut off of 03 Mar 2008; up to 51 months|Intent to Treat population includes all participants who were randomized to study drug.||weeks||95% Confidence Interval|Median
854635|NCT00424047|Secondary|Time to First Worsening on the Eastern Cooperative Oncology Group (ECOG) Performance Scale (Later Cut-off Date of 02 March 2008)|The time to first worsening of the ECOG performance status was calculated as the time from randomization to the date of the first worsening compared with the last ECOG evaluation obtained prior to randomization. Data were censored at the last date that the participant was known to be unchanged or improved from before randomization for the participants who had not had worsened at the time of the analysis and for the patients who were lost to follow-up before worsening in the ECOG performance status was documented.|Randomization to cut off date of 02 March 2008; up to 51 months|Intent to Treat includes all participants who were randomized to study drug; six ECOG scores were missing at the March 2008 cut-off.||weeks||95% Confidence Interval|Median
854636|NCT00424047|Secondary|Time to First Worsening on the Eastern Cooperative Oncology Group (ECOG) Performance Scale|The time to first worsening of the ECOG performance status was calculated as the time from randomization to the date of the first worsening compared with the last ECOG evaluation obtained prior to randomization. Data were censored at the last date that the participant was known to be unchanged or improved from before randomization for the participants who had not had worsened at the time of the analysis and for the patients who were lost to follow-up before worsening in the ECOG performance status was documented.|Randomization to cut off date of 03 August 2005; up to 24 months|Intent to Treat includes all participants who were randomized to study drug; a total of six ECOG scores were missing at the time of the Aug 2005 cut-off.||weeks||95% Confidence Interval|Median
854637|NCT00424047|Primary|Kaplan-Meier Estimate of Time to Tumor Progression (TTP) (Later Cut-off Date of 02 Mar 2008)|Time to progression was calculated as the time from randomization to the first occurrence of disease progression, as determined by a detailed review of all the myeloma response assessment data using the Bladé criteria (Bladé, 1998). Disease progression was also based on bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia.|From randomization up to cut-off date of 02 March 2008; up to 51 months|Intent to treat included all participants who were randomized.||weeks||95% Confidence Interval|Median
854638|NCT00424047|Post-Hoc|Kaplan-Meier Estimate of Duration of Response|Duration of response was calculated for responders and defined as the time from the first observation of a response (e.g., the first time that the appropriate decrease in M-protein level was observed for confirmed responders) to the first documented progression or relapse. Response duration was censored at the last adequate assessment showing evidence of no progression.|Up to data cut off of 03 August 2005; up to 24 months|Intent to Treat population includes all participants who were randomized to study drug.||weeks||95% Confidence Interval|Median
854639|NCT00424047|Secondary|Time to First Symptomatic Skeletal-related Event (SRE) (Clinical Need for Radiation or Surgery to Bone)|Time from randomization to the date of the first occurrence of a symptomatic SRE (clinical need for radiotherapy or surgery to bone).|Up to unblinding data cut off of 03 August 2005; up to 24 months|Analysis not performed due to an insufficient number of participants with SRE||participants|||Number
854640|NCT00424047|Secondary|Number of Participants With Adverse Events (AE)|"An AE is any sign, symptom, illness, or diagnosis that appears or worsens during the course of the study. Treatment-emergent AEs (TEAEs) are any AE occurring or worsening on or after the first treatment of the study drug and within 30 days after the last cycle end date of study drug. A serious AE = any AE which results in death; is life-threatening; requires or prolongs existing inpatient hospitalization; results in persistent or significant disability is a congenital anomaly/birth defect; constitutes an important medical event.
The severity of AEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE, Version 2.0): Grade 1 = Mild (no limitation in activity or intervention required); Grade 2 = Moderate (some limitation in activity; no/minimal medical intervention required); Grade 3 = Severe (marked limitation in activity; medical intervention required, hospitalization possible); Grade 4 = Life-threatening; Grade 5 = Death."|From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 25 June 2013; up to 90 months|The safety population includes all participants who received at least one dose of study drug regimen||participants|||Number
854641|NCT00424047|Secondary|Myeloma Response Rates Based on the Reviewers Best Response Assessment (Later Cut-off Date of 02 March 2008)|Complete Response (CR): Disappearance of monoclonal paraprotein and maintained for ≥ 6 weeks . Remission Response (RR):75-99% reduction in the level of the serum monoclonal paraprotein compared to baseline; 90-99% reduction in 24-hr urinary light chain excretion. Partial Response (PR): 50-74% reduction in the level of monoclonal paraprotein compared to baseline; 50-89% reduction in 24-hr urinary light chain excretion. Stable Disease (SD): Criteria for PR or PD have not been met. Plateau Phase: If PR, stable monoclonal paraprotein values (within 25% above or below nadir)/stable soft tissue plasmacytomas maintained for at least 3 months. Progressive Disease (PD): Reappearance of serum or urinary monoclonal paraprotein on immunofixation or electrophoresis on two consecutive occasions at least one week apart. Increase of percentage of plasma cells in bone marrow aspirate or biopsy to ≥ 5%. Development of at least one new lytic bone lesion or soft tissue plasmacytoma.|Randomization to data cut-off of 02 Mar 2008; up to 51 months|Intent to Treat Population includes all participants who were randomized||percentage of participants|||Number
854642|NCT00424047|Secondary|Summary of Myeloma Response Rates Based on Best Response Assessment|Complete Response (CR): Disappearance of monoclonal paraprotein and maintained for ≥ 6 weeks . Remission Response (RR):75-99% reduction in the level of the serum monoclonal paraprotein compared to baseline; 90-99% reduction in 24-hr urinary light chain excretion. Partial Response (PR): 50-74% reduction in the level of monoclonal paraprotein compared to baseline; 50-89% reduction in 24-hr urinary light chain excretion. Stable Disease (SD): Criteria for PR or PD have not been met. Plateau Phase: If PR, stable monoclonal paraprotein values (within 25% above or below nadir)/stable soft tissue plasmacytomas maintained for at least 3 months. Progressive Disease (PD): Reappearance of serum or urinary monoclonal paraprotein on immunofixation or electrophoresis on two consecutive occasions at least one week apart. Increase of percentage of plasma cells in bone marrow aspirate or biopsy to ≥ 5%. Development of at least one new lytic bone lesion or soft tissue plasmacytoma.|Randomization to 03 August 2005; up to 24 months|Intent to Treat Population includes all participants who were randomized||percentage of participants|||Number
854643|NCT00424047|Secondary|Kaplan-Meier Estimate of Overall Survival (OS) (Later Cut-off Date of 02 March 2008)|OS was calculated as the time from randomization to death from any cause. OS was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented.|Randomization to data cut off of 02 March 2008; up to 51 months|Intent to Treat population includes all participants who were randomized.||weeks||95% Confidence Interval|Median
854644|NCT00424047|Secondary|Kaplan-Meier Estimate of Overall Survival (OS)|OS was calculated as the time from randomization to death from any cause. OS was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented.|Randomization to data cut off of 03 August 2005; up to 24 months|Intent to Treat population includes all participants who were randomized.||weeks||95% Confidence Interval|Median
854645|NCT00424047|Primary|Kaplan-Meier Estimate of Time to Tumor Progression (TTP)|Time to progression was calculated as the time from randomization to the first occurrence of disease progression, as determined by a detailed review of all the myeloma response assessment data using the Bladé criteria (Bladé, 1998). Disease progression was also based on bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia.|From randomization up to cut-off date of 03 August 2005; up to 24 months|Intent to treat included all participants who were randomized.||weeks||95% Confidence Interval|Median
854679|NCT00304187|Primary|Gastric Emptying Rate||Measured at Week 7||||||
854680|NCT00304187|Primary|Binge Frequency|Binge frequency wass assessed by patient diary. All patients were asked to keep a diary of the number of daily binge eating and vomiting episodes which was collected at each weekly visit.|Measured at Week 7|Participants for analysis included 13 patients in the erythromycin and 13 patients in the placebo group who completed at least 5 weeks of drug treatment.||Binge Episodes/Week||Standard Deviation|Mean
854685|NCT00056160|Secondary|Time to First Worsening of Eastern Cooperative Oncology Group (ECOG) Performance Status Scale (Best Score=0, Fully Active, Able to Carry on All Pre-disease Performance Without Restriction; Worst Score=5, Dead.)|The time to first worsening on the ECOG Performance Scale was calculated as the time from randomization to the date of the first worsening compared to the last ECOG evaluation obtained prior to randomization.|30 weeks (mean time to first worsening of ECOG performance status for CC-5013/Dex treatment group)|Analysis conducted on the Intent-To-Treat (ITT) Population. The ITT Population was defined as all subjects randomized.||Weeks||Standard Deviation|Mean
854686|NCT00056160|Secondary|Myeloma Response|The overall confirmed response that was maintained for ≥6 weeks. Complete Response (CR):Disappearance of monoclonal paraprotein. Remission Response (RR):75-99% reduction in monoclonal paraprotein/90-99% reduction in 24-hr urinary light chain excretion. Partial Response (PR):50-74% reduction in monoclonal paraprotein/50-89% reduction in 24-hr urinary light chain excretion. Stable Disease (SD):Criteria for PR or PD not met. Plateau Phase:If PR, stable monoclonal paraprotein (within 25% above or below nadir)/stable soft tissue plasmacytomas. Progressive Disease (PD):Disease worsens.|Up to Unblinding (07 Jun 2005)|Analysis conducted on the Intent-To-Treat (ITT) Population. The ITT Population was defined as all subjects randomized. Results reported (Response) are numbers of subjects.||Participants|||Number
854687|NCT00056160|Secondary|Overall Survival|Overall survival was calculated as the time from randomization to death from any cause.|170 weeks (median overall survival of CC-5013/Dex treatment group)|Analysis conducted on the Intent-To-Treat (ITT) Population. The ITT Population was defined as all subjects randomized.||Weeks||95% Confidence Interval|Median
854691|NCT02730819|Secondary|Investigator Assessment of Global Improvement From Baseline|The investigator compared the extent of melasma at 20 weeks to a full-face photograph obtained in a standardized manner at baseline. It is a dynamic 7-point scale (0=completely clear to 7=worse).|baseline, 20 weeks|19 participants were enrolled, but 9 participants were lost to follow-up over the course of the study.||Participants|||Count of Participants
854692|NCT02730819|Secondary|Change in Melasma Quality of Life Scale (MELASQOL)|The Melasma Quality of Life Scale has 10 items, with responses ranging from 0 (no response) to 7 (bothered all the time. The range of possible scores is 0-70, with a higher score indicating a worse melasma-related quality of life.|baseline, 20 weeks|19 participants were enrolled, but 9 participants were lost to follow-up over the course of the study.||units on a scale||Full Range|Median
854693|NCT02730819|Primary|Change in Melasma Area and Severity Index (MASI) Score|"Severity of melasma in each of the four regions (forehead, right malar region, left malar region and chin) is assessed on % of the total area involved (A), darkness (D), and homogeneity (H).
Scoring for % area involved: 0=none; 1=<10%; 2=10-29%; 3=30-49%; 4=50-69%; 5=70-89%; and 6=90-100%. Darkness scoring (hyperpigmentation): 0=normal skin; 1=barely visible; 2=mild; 3=moderate; 4=severe. Homogeneity scoring: 0=normal skin color; 1=specks of involvement; 2=small patchy areas of involvement <1.5 cm diameter; 3=patches of involvement >2 cm diameter; 4=uniform skin involvement without any clear areas).
To calculate the MASI score, the sum of the severity grade for darkness (D) and homogeneity (H) is multiplied by the numerical value of the areas (A) involved and by the percentages of the four facial areas (10-30%). Total MASI score: Forehead 0.3 (D+H)A + right malar 0.3 (D+H)A + left malar 0.3 (D+H)A + chin 0.1 (D+H)A. The total score can range from 0 (normal) to 48 (severe)."|Baseline, 20 weeks|19 participants were enrolled, but 9 participants were lost to follow-up over the course of the study.||units on a scale||Full Range|Median
854694|NCT02584790|Secondary|The Sensitivity, Specificity, Positive Predicted Valve and Negative Predicted Valve of Detecting Mucosal Residual NPC Using NBI Suspicious/ Non Suspicous Pattern|"Non suspicious pattern = grade A + grade B Suspicious pattern = grade C + D
The sensitivity, specificity, positive predicted valve and negative predicted valve of detecting mucosal residual NPC using NBI suspicious/ non suspicous pattern can be thus calculated."|Post-radiotherapy eight weeks|NBI non suspicious pattern = 36 NBI suspcious pattern = 4 Total = 40||Percentage|||Number
854695|NCT02584790|Secondary|Assocication of Residual NPC With NBI Non Suspicious Pattern Group and NBI Suspicious Pattern Group|"Non suspicious pattern = grade A + grade B Suspicious pattern = grade C + D
The sensitivity, specificity, positive predicted valve and negative predicted valve of detecting mucosal residual NPC using NBI suspicious/ non suspicous pattern can be thus calculated."|Post-radiotherapy eight weeks|NBI non suspicious pattern = 36 NBI suspcious pattern = 4 Total = 40||Participants|||Count of Participants
854696|NCT02584790|Primary|Positive Nasopharynx Biopsy Results Detected by NBI System in Those Post-radiotherapy 8th Week NPC Patient|"4 grading of NBI vessel patterns can be identified in those post-radiotherapy 8 weeks NPC patients.
Grade A: normal vessel size and length, regular pattern Grade B: normal vessel size, short, regular spiderweb like pattern Grade C: irregular vessel size and length, distorted and irregular pattern Grade D: thickened vessel size, elongated, distorted, and earthworm pattern"|Post-radiotherapy 8th week|||participants|||Number
854697|NCT02480621|Primary|Pain Levels on a Visual Analog Scale ( VAS)|A Visual Analog Scale (VAS) ranging from 0 to 10 in increments of 1 was used to both qualitatively and quantitatively assess the level and severity of pain during the time points ranging from the immediate post-operative period through 72 hours post-operative. Each number on the scale is accompanied by a visual facial expression that indicates the level of pain, discomfort, and distress appropriate to the number on the scale. The more severe the level of pain, the higher the corresponding number and more distressing the accompanying facial expression. A VAS score of 0 indicates no active pain level and is accompanied by a pleasantly smiling face whereas a VAS score of 10 indicates the most severe active pain level and is accompanied by a visibly-distraught face that is frowning, grimacing, and sweating. The combination of facial expressions and numbers is supposed to provide a language-independent, validated means of assessing pain levels.|Immediate post-operative period until 72 hours post-operatively|||units on a scale||Standard Deviation|Mean
854698|NCT02478632|Secondary|Change From Baseline in Lumbar Spine and Total Hip BMD T-scores and Z-scores by Baseline Third Agent|Change from Baseline to Wk 48 in total hip and lumbar spine BMD expressed as T and Z-scores assessed by third agent class. Change from Baseline was calculated as value at Wk 48 minus Baseline. T-score is the number of standard deviations above or below mean BMD of a 30-year-old of the same sex. T and Z score calculations utilised caucasian reference values and score ranges are generally diverse/wide. T-scores can be positive (above mean) or negative (below mean). T- scores ≥ -1.0 are considered normal. Z-score is the number of standard deviations above or below mean BMD for a reference population of same age and sex. Z-scores can be positive (above mean) or negative (below mean) and the range depends on extreme values representing subject data. An ANCOVA model adjusted for Baseline T/Z-score value was used to compare change from Baseline to Wk 48 in total hip BMD or in lumbar spine BMD between the arms by third agent class: INSTI, NNRTI or PI. Mean and 95 percent CI were estimated.|Baseline and Week 48|ITT-ED Population||Score on a scale||95% Confidence Interval|Mean
854699|NCT02478632|Secondary|Percent Change From Baseline in Lumbar Spine and Total Hip BMD by Baseline Third Agent|Percent change from Baseline (Day 1) to Week 48 in total hip and lumbar spine BMD (expressed as areal density in g/cm2) assessed by third agent class at Baseline. Percent change from Baseline was calculated as value at Week 48 minus Baseline value divided by Baseline value multiplied by 100. An ANCOVA model adjusted for Baseline BMD values was used to compare the difference in percent change from Baseline to Week 48 in total hip BMD or in lumbar spine BMD between the DTG+RPV and CAR arms by third agent class: integrase inhibitor (INSTI), non-nucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI). Mean and 95 percent CI were estimated. For BMD expressed as areal density (g/ cm2 ), most BMD values, statistically, would fall within + or – 3 standard deviations of what is considered normal. Only those participants with evaluable DEXA scans at Baseline and Week 48 were included.|Baseline and Week 48|ITT-ED Population||g/cm^2||95% Confidence Interval|Mean
854700|NCT02478632|Secondary|Change From Baseline in Lumbar Spine and Total Hip BMD Assessed by T-score and Z-score|Change from Baseline in lumbar spine and total hip BMD was assessed by T-scores and Z-scores at Baseline and Week (Wk) 48. Change from Baseline (Day 1) was calculated as the value at Wk 48 minus Baseline. T-score is the number of standard deviations above or below the mean BMD of a 30-year-old of the same sex. T and Z score calculations utilised caucasian reference values and score ranges are generally diverse/wide. T-scores can be positive (above mean) or negative (below mean).T- scores ≥ -1.0 are considered normal. The Z-score is the number of standard deviations above or below the mean BMD for a reference population of same age and sex. Z-scores can be positive (above mean) or negative (below mean) and the range depends on extreme values representing subject data. An ANCOVA model adjusted for Baseline T-score/Z-score, age at study entry, Baseline BMI was used to compare the difference in change from Baseline at Wk 48 in total hip BMD and in lumbar spine BMD between arms.|Baseline and up to Week 48|ITT-ED Population||Score on a scale||95% Confidence Interval|Mean
854701|NCT02478632|Secondary|Percent Change From Baseline in Lumbar Spine BMD|Percent change in BMD as specified by DEXA scans of the 'lumbar spine' which included the first lumbar vertebra (L1) to the fourth lumbar vertebra (L4) was assessed by areal density at Baseline and Week 48. The difference is adjusted percent change from Baseline to Week 48 between treatment groups. The estimated value in the statitical analysis is this difference and the upper and lower limit values shown are the 95% confidence intervals. The Baseline was considered as Visit 1 value and percent change from Baseline was calculated as Value at Week 48 minus Baseline value divided by Baseline value multiplied by 100. An ANCOVA model adjusted for the Baseline BMD value, age at study entry and Baseline BMI was used to compare the difference in percentage change from Baseline at week 48 in lumbar spine BMD between the DTG+RPV and CAR arms. Mean and 95 percent CI were estimated.|Baseline and Week 48|ITT-ED Population||g/cm^2||95% Confidence Interval|Mean
854702|NCT02478632|Primary|Percent Change From Baseline in Total Hip Bone Mineral Density (BMD)|Percent change in BMD (expressed as areal density in g/cm2) as specified by dual energy X-ray absorptiometry (DEXA) scans of the left ‘total hip’ which included the femoral neck, trochanter and inter-trochanter areas was assessed by areal density at Baseline and Week 48. The difference is adjusted percent change from Baseline to Week 48 between treatment groups. The estimated value in the statistical analysis is this difference and the upper and lower limit values shown are the 95% confidence intervals. The Baseline was considered as Visit 1 and percent change from Baseline was calculated as Value at Week 48 minus Baseline value divided by Baseline value multiplied by 100. An analysis of covariance (ANCOVA) model was used to compare the difference. The analysis was performed on Intent-to-Treat exposed DEXA (ITT-ED) Population which comprised of all participants in the ITT-E Population who received at least one dose of study treatment, and who were registered for the 202094 study.|Baseline and Week 48|ITT-ED Population||gram per centimeter square (g/cm^2)||95% Confidence Interval|Mean
854703|NCT02404103|Primary|Impulse Oscillometry (IOS) Resistance 5 (R5)|Resistance of the respiratory system at 5 Hz is a measure of total airway resistance. Elevated value is indicative of respiratory dysfunction.|initial visit and six week followup|Only data for subjects who completed study are presented.||cmH2O(L/s)||Standard Deviation|Mean
854704|NCT02404103|Primary|Spirometry Forced Expiratory Flow 25-75% (FEF 25-75%)|Indirectly assess small airway function.|baseline and six week followup|Those subjects that completed the study protocol.||% of predicted||Standard Deviation|Mean
854705|NCT02404103|Primary|Impulse Oscillometry (IOS) Area of Reactance (AX) After Flunisolide Treatment|A composite measure of small airway dysfunction. A reduction in IOS scores indicate an improvement.|Baseline and six week followup|Those subjects that completed the study protocol.||cmH2O/L||Standard Deviation|Mean
854706|NCT02404103|Primary|Spirometry Forced Expiratory Volume 1 (FEV1) After Flunisolide|the most used outcome in respiratory studies|Before and after treatment at baseline and six week followup|Those subjects that completed the study protocol.||% of predicted||Standard Deviation|Mean
854707|NCT02317016|Secondary|Assessment of the Metabolite to Parent Ratios of AUCtau (MRAUCtau) for AZ5104 and AZ7550 Following Administration of AZD9291 and Rosuvastatin Together|Assessment of MRAUCtau for AZ5104 and AZ7550 (calculated as AZ5104 to AZD9291 and AZ7550 to AZD9291) after multiple dosing. AZD9291 doses were first without, then with rosuvastatin (Days 4 to 31; Period 2 and Day 32; Period 3, respectively).|Blood samples collected pre-dose on Days 11, 18, and 25 and on Day 32 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post AZD9291 dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.||Ratio||Geometric Coefficient of Variation|Geometric Mean
854708|NCT02317016|Secondary|Assessment of the Metabolite to Parent Ratios of Css,Max (MRCss,Max) for AZ5104 and AZ7550 Following Administration of AZD9291 and Rosuvastatin Together|Assessment of MRCss,max for AZ5104 and AZ7550 (calculated as AZ5104 to AZD9291 and AZ7550 to AZD9291) after multiple dosing. AZD9291 doses were first without, then with rosuvastatin (Days 4 to 31; Period 2 and Day 32; Period 3, respectively).|Blood samples collected pre-dose on Days 11, 18, and 25 and on Day 32 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post AZD9291 dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.||Ratio||Geometric Coefficient of Variation|Geometric Mean
854709|NCT02317016|Secondary|Assessment of Apparent Plasma Clearance at Steady State (CLss/F) for AZD9291 Following Administration of AZD9291 and Rosuvastatin Together|Rate and extent of absorption for AZD9291 by assessment of CLss/F after multiple dosing. AZD9291 doses were first without, then with rosuvastatin (Days 4 to 31; Period 2 and Day 32; Period 3, respectively).|Blood samples collected pre-dose on Days 11, 18, and 25 and on Day 32 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post AZD9291 dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.||L/h||Geometric Coefficient of Variation|Geometric Mean
854737|NCT02135848|Secondary|Relationship of Pharmacokinetic Parameters to the Pharmacodynamic Assessments Performed in This Study|A formal pharmacokinetic /pharmacodynamic analysis and pharmacokinetic /pharmacodynamic modelling for exposure relationships to endpoints was planned. The data for this outcome was not collected.|Visit 2 (Day 1): pre-dose, 1 hour, 2 hours and 3.5 hours post-dose, Visit 3 (Day 2)-post acute, Visit 4 (Day 16)-rescreen, Visit 5 (Day 23)-Baseline chronic and end of treatment (14 days after Visit 5) or early termination (between Visit 2 and 6)|The data for this outcome measure was not collected.|||||
854710|NCT02317016|Secondary|Assessment of Minimum Plasma Concentration at Steady State (Css,Min) for AZD9291, and AZ5104 and AZ7550 (Metabolites) Following Administration of AZD9291 and Rosuvastatin Together|Rate and extent of absorption for AZD9291, and AZ5104 and AZ7550 (metabolites) by assessment of Css,min over the dosing interval. AZD9291 doses were first without, then with rosuvastatin (Days 4 to 31; Period 2 and Day 32; Period 3, respectively).|Blood samples collected pre-dose on Days 11, 18, and 25 and on Day 32 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post AZD9291 dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.||nM||Geometric Coefficient of Variation|Geometric Mean
854711|NCT02317016|Secondary|Assessment of Time to Reach Maximum Plasma Concentration at Steady State (Tss,Max) for AZD9291, and AZ5104 and AZ7550 (Metabolites) Following Administration of AZD9291 and Rosuvastatin Together|Rate and extent of absorption for AZD9291, and AZ5104 and AZ7550 (metabolites) by assessment of tss,max after multiple dosing. AZD9291 doses were first without, then with rosuvastatin (Days 4 to 31; Period 2 and Day 32; Period 3, respectively).|Blood samples collected pre-dose on Days 11, 18, and 25 and on Day 32 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post AZD9291 dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.||h||Full Range|Median
854712|NCT02317016|Secondary|Assessment of Maximum Plasma Concentration at Steady State (Css,Max) for AZD9291, and AZ5104 and AZ7550 (Metabolites) Following Administration of AZD9291 and Rosuvastatin Together|Rate and extent of absorption for AZD9291, and AZ5104 and AZ7550 (metabolites) by assessment of Css,max after multiple dosing. AZD9291 doses were first without, then with rosuvastatin (Days 4 to 31; Period 2 and Day 32; Period 3, respectively).|Blood samples collected pre-dose on Days 11, 18, and 25 and on Day 32 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post AZD9291 dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.||nM||Geometric Coefficient of Variation|Geometric Mean
854713|NCT02317016|Secondary|Assessment of Area Under the Plasma Concentration-time Curve During the Dosing Interval (AUCtau) for AZD9291, and AZ5104 and AZ7550 (Metabolites) Following Administration of AZD9291 and Rosuvastatin Together|Rate and extent of absorption for AZD9291, and AZ5104 and AZ7550 (metabolites) by assessment of AUCtau. AZD9291 doses were first without, then with rosuvastatin (Days 4 to 31; Period 2 and Day 32; Period 3, respectively).|Blood samples collected pre-dose on Days 11, 18, and 25 and on Day 32 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post AZD9291 dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.||nanomolar * h (nM*h)||Geometric Coefficient of Variation|Geometric Mean
854714|NCT02317016|Secondary|Assessment of Terminal Elimination Half-life (t1/2[lambda_z]) for Rosuvastatin After a Single Dose Alone and in Combination With AZD9291|Rate and extent of absorption of rosuvastatin by assessment of t1/2(lambda_z). Single rosuvastatin doses were first without, then with AZD9291 (Day 1; Period 1 and Day 32; Period 3, respectively).|Blood samples collected on Days 1 and 32 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, and 72 hours post rosuvastatin dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.||h||Geometric Coefficient of Variation|Geometric Mean
854715|NCT02317016|Secondary|Assessment of Apparent Volume of Distribution (Vz/F) for Rosuvastatin After a Single Dose Alone and in Combination With AZD9291|Rate and extent of absorption of rosuvastatin by assessment of Vz/F. Single rosuvastatin doses were first without, then with AZD9291 (Day 1; Period 1 and Day 32; Period 3, respectively).|Blood samples collected on Days 1 and 32 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, and 72 hours post rosuvastatin dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.||L||Geometric Coefficient of Variation|Geometric Mean
854716|NCT02317016|Secondary|Assessment of Apparent Plasma Clearance (CL/F) for Rosuvastatin After a Single Dose Alone and in Combination With AZD9291|Rate and extent of absorption of rosuvastatin by assessment of CL/F. Single rosuvastatin doses were first without, then with AZD9291 (Day 1; Period 1 and Day 32; Period 3, respectively).|Blood samples collected on Days 1 and 32 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, and 72 hours post rosuvastatin dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.||Litre / h (L/h)||Geometric Coefficient of Variation|Geometric Mean
854717|NCT02317016|Secondary|Assessment of Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration at Time “t” (AUC0-t) for Rosuvastatin After a Single Dose Alone and in Combination With AZD9291|Rate and extent of absorption of rosuvastatin by assessment of AUC0-t. Single rosuvastatin doses were first without, then with AZD9291 (Day 1; Period 1 and Day 32; Period 3, respectively).|Blood samples collected on Days 1 and 32 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, and 72 hours post rosuvastatin dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
854718|NCT02317016|Secondary|Assessment of Time to Maximum Plasma Concentration (Tmax) for Rosuvastatin After a Single Dose Alone and in Combination With AZD9291|Rate and extent of absorption of rosuvastatin by assessment of tmax. Single rosuvastatin doses were first without, then with AZD9291 (Day 1; Period 1 and Day 32; Period 3, respectively).|Blood samples collected on Days 1 and 32 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, and 72 hours post rosuvastatin dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.||h||Full Range|Median
854969|NCT00625404|Secondary|Participant Report of Change in Number of Sexual Partners|Difference in mean number of reported sexual partners between final study visit and enrollment visit|Up to 52 weeks|Women reporting on sexual behavior during follow-up||mean number of sexual partners||Standard Deviation|Mean
854719|NCT02317016|Primary|Assessment of AUC From Time Zero Extrapolated to Infinity for Rosuvastatin After a Single Dose Alone and in Combination With AZD9291|Rate and extent of absorption of rosuvastatin by assessment of AUC from time zero extrapolated to infinity. Single rosuvastatin doses were first without, then with AZD9291 (Day 1; Period 1 and Day 32; Period 3, respectively).|Blood samples collected on Days 1 and 32 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, and 72 hours post rosuvastatin dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.||ng * h o u r per mL (ng*h/mL )||Geometric Coefficient of Variation|Geometric Mean
854720|NCT02317016|Primary|Assessment of Maximum Plasma Concentration (Cmax) for Rosuvastatin After a Single Dose Alone and in Combination With AZD9291|Rate and extent of absorption of rosuvastatin by assessment of Cmax. Single rosuvastatin doses were first without, then with AZD9291 (Day 1 [Period 1] and Day 32 [Period 3], respectively).|Blood samples collected on Days 1 and 32 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, and 72 hours post rosuvastatin dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.||nanogram per millilitre (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
854721|NCT02260791|Other Pre-specified|Trough Adalimumab Concentration|Blood samples for the quantification of adalimumab concentration in serum were collected at Baseline (Week 0), prior to dosing at Weeks 2, 4, 12 and 20, and Week 24. Samples were taken prior to dosing (trough samples).|Week 24|The Pharmacokinetic Analysis Set (PKAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and had at least 1 serum adalimumab concentration result after receiving randomised treatment.||ng/mL||95% Confidence Interval|Geometric Least Squares Mean
854722|NCT02260791|Other Pre-specified|Percentage of Patients Developing Anti-drug Antibodies (ADAs)|Blood samples for the assessment of ADA activity were collected at Baseline (Week 0), prior to dosing at Weeks 2, 4, 12, and 24.|Week 24|The Safety Analysis Set was defined as the set of patients who received at least 1 dose of randomised treatment. The Safety Analysis Set was used for all safety analyses. Patient safety data were analysed according to treatment actually received.||percentage of patients|||Number
854723|NCT02260791|Secondary|DAS28 Score Based on Erythrocyte Sedimentation Rate (DAS28-ESR)|The DAS28 score is a combined index that has been developed to measure the disease activity in patients with RA and has been extensively validated for its use in clinical studies. The DAS28-ESR assessment involved evaluating the number of tender (TJC) and swollen (SJC) joints (out of 28 specified joints), serum ESR, and patient global assessment of disease activity (VAS from 0 to 100, very well to extremely bad). The individual results are summed using a formula. The DAS28 is a number on a scale from 0 to 10 indicating the current activity of the patient's RA. A higher score indicates higher disease activity.|Baseline, Week 12 and Week 24|The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.||units on a scale||Standard Deviation|Mean
854724|NCT02260791|Secondary|DAS28-CRP Score Over Time|The DAS28 score is a combined index that has been developed to measure the disease activity in patients with RA and has been extensively validated for its use in clinical studies. The DAS28-CRP assessment involved evaluating the number of tender (TJC) and swollen (SJC) joints (out of 28 specified joints), serum CRP, and patient global assessment of disease activity (VAS from 0 to 100, very well to extremely bad). The individual results are summed using a formula. The DAS28 is a number on a scale from 0 to 10 indicating the current activity of the patient's RA. A higher score indicates higher disease activity.|Baseline and Week 24|The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.||units on a scale||Standard Deviation|Mean
854725|NCT02260791|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI)|The HAQ-DI is a 20-question, self-administered instrument that measures the patient's functional ability on a 4-level difficulty scale (0 to 3, with 0 representing normal or no difficulty and 3 representing inability to perform). Eight categories of functioning are included: dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. This scale is sensitive to change and is a good predictor of future disability. HAQ-DI is a value of the individual ACR core set variables.|Week 24|The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.||units on a scale||Standard Deviation|Mean
854726|NCT02260791|Secondary|Patient's Assessment of Pain|An injection site pain visual analogue score (VAS) will be administered to the patient. To determine the extent of the pain, patients will be asked to place a small vertical mark on a horizontal scale from 0 to 100, the ends of which are labelled with the extreme responses to be measured (“No pain” at 0 and “Intolerable pain” at 100). Patient's assessment of pain is a value of the individual ACR core set variables.|Week 24|The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.||units on a scale||Standard Deviation|Mean
854727|NCT02260791|Secondary|Physician Assessment of Disease Activity|Physician assessment of disease activity visual analogue scale (VAS) will be assessed on 100-point scale (ranging from very low (0) to very high (100)). The physician assessment of disease activity VAS will contribute to the calculation of ACR20, ACR50 and ACR70 response.|Week 24|The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.||units on a scale||Standard Deviation|Mean
854970|NCT00625404|Primary|Confirmed Grade 3 or Higher AST Elevation|Grade 3 or higher AST elevation was defined as ≥ 2.6 times the upper limit of normal|Through 52 weeks on product and 4 weeks post-product|||participants|||Number
854728|NCT02260791|Secondary|Patient Assessment of Disease Activity|Patient assessment of disease activity visual analogue scale (VAS) will be assessed on 100-point scales (ranging from very well (0) to extremely bad (100)).The patient assessment of disease activity VAS will contribute to the calculation of the DAS28 score. The patient assessment of disease activity VAS will contribute to the calculation of ACR20, ACR50 and ACR70 response.|Week 24|The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.||units on a scale||Standard Deviation|Mean
854729|NCT02260791|Secondary|Analysis of Serum C-Reactive Protein (CRP) Concentration|Analysis of serum C-Reactive Protein (CRP) concentrations for inclusion in the ACR20/50/70 and DAS28-CRP scores was performed by a central laboratory. Elevation of CRP is a nonspecific marker of inflammation. Values above 10 mg/L were considered to be abnormally high. Decrease in level of CRP indicates reduction in inflammation.|Week 24|The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.||mg/L||Standard Deviation|Mean
854730|NCT02260791|Secondary|Tender Joint Count|Counts of tender joints from amongst 68 selected joints were performed by a trained and qualified joint assessor using standardised techniques recommended by the European League Against Rheumatism (EULAR). Joints were classified as tender/not tender giving a total possible tender joint count score of 0 to 68 with higher scores indicating severe disease.Tender joint count is a value of the individual ACR core set variables.|Week 24|The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.||Count / Score||Standard Deviation|Mean
854731|NCT02260791|Secondary|Swollen Joint Count|Counts of swollen joints from amongst 66 selected joints performed by a trained and qualified joint assessor using standardised techniques recommended by the European League Against Rheumatism (EULAR). Joints were classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66 with higher scores indicating severe disease. Swollen joint count is a value of the individual ACR core set variables.|Week 24|The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.||Count / Score||Standard Deviation|Mean
854732|NCT02260791|Secondary|ACR70 Response Rates Over Time|"An ACR70 response meant that the patient achieved a 70% improvement in Tender Joint Count and Swollen Joint Count and in at least 3 of the other 5 Core Data Set elements listed below.
Acute phase reactant (CRP)
Patient global assessment of disease activity
Physician global assessment of disease activity
Patient pain scale
Disability/functional questionnaire (patient completed Health AssessmentQuestionnaire Disability Index [HAQ-DI])"|Week 24|The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.||percentage of responders||95% Confidence Interval|Number
854733|NCT02260791|Secondary|ACR50 Response Rates Over Time|"An ACR50 response meant that the patient achieved a 50% improvement in Tender Joint Count and Swollen Joint Count and in at least 3 of the other 5 Core Data Set elements listed below.
Acute phase reactant (CRP)
Patient global assessment of disease activity
Physician global assessment of disease activity
Patient pain scale
Disability/functional questionnaire (patient completed Health AssessmentQuestionnaire Disability Index [HAQ-DI])"|Week 24|The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.||percentage of responders||95% Confidence Interval|Number
854734|NCT02260791|Secondary|ACR20 Response Rates Over Time|"An ACR20 response meant that the patient achieved a 20% improvement in Tender Joint Count and Swollen Joint Count and in at least 3 of the other 5 Core Data Set elements listed below.
Acute phase reactant (CRP)
Patient global assessment of disease activity
Physician global assessment of disease activity
Patient pain scale
Disability/functional questionnaire (patient completed Health Assessment Questionnaire Disability Index [HAQ-DI])"|Week 24|The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment.Patients were analysed according to the randomised treatment in the primary analysis.||percentage of responders||95% Confidence Interval|Number
854735|NCT02260791|Secondary|Disease Activity Score 28 (DAS28) Based on C-reactive Protein (DAS28-CRP) Score|The DAS28-CRP assessment involved evaluating the number of tender (TJC) and swollen (SJC) joints (out of 28 specified joints), serum CRP, and patient global assessment of disease activity (VAS from 0 to 100, very well to extremely bad). The DAS28-CRP is a number on a scale from 0 to 10 indicating the current activity of the patient’s RA. A higher score indicates higher disease activity.|Week 24|The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.||units on a scale||Standard Deviation|Mean
854736|NCT02260791|Primary|American College of Rheumatology (ACR) 20 Response Rate|"The primary efficacy endpoint was the ACR20 response rate at Week 24.
An ACR20 response meant that the patient achieved a 20% improvement in Tender Joint Count and Swollen Joint Count and in at least 3 of the other 5 Core Data Set elements listed below.
Acute phase reactant (CRP)
Patient global assessment of disease activity
Physician global assessment of disease activity
Patient pain scale
Disability/functional questionnaire (patient completed Health Assessment Questionnaire Disability Index [HAQ-DI])"|Week 24|The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.||Percentage of participants||95% Confidence Interval|Number
854738|NCT02135848|Secondary|Derived Plasma GSK1278863 Pharmacokinetic Parameter - Time to Maximum Plasma Concentration (T-max) and Last Time Point Where the Concentration is Above the Limit of Quantification (T-last)|Blood samples for pharmacokinetic analysis of GSK1278863 and selected metabolites were collected at the following time points: Visit 2-Baseline acute: pre-dose, 1 hour, 2 hours and 3.5 hours post-dose, Visit 3-post acute, Visit 4-rescreen, Visit 5-Baseline chronic and end of treatment or early termination. The actual date and time of each blood sample collection was recorded.|Visit 2 (Day 1): pre-dose, 1 hour, 2 hours and 3.5 hours post-dose, Visit 3 (Day 2)-post acute, Visit 4 (Day 16)-rescreen, Visit 5 (Day 23)-Baseline chronic and end of treatment (14 days after Visit 5) or early termination (between Visit 2 and 6)|Pharmacokinetic concentration population. Only those participants available at the specified time points were analyzed.||Hour||Full Range|Median
854739|NCT02135848|Secondary|Derived Plasma GSK1278863 Pharmacokinetic Parameter -Area Under the Curve (AUC [0-t])|Blood samples for pharmacokinetic analysis of GSK1278863 and selected metabolites were collected at the following time points: Visit 2-Baseline acute: pre-dose, 1 hour, 2 hours and 3.5 hours post-dose, Visit 3-post acute, Visit 4-rescreen, Visit 5-Baseline chronic and end of treatment or early termination. The actual date and time of each blood sample collection was recorded.|Visit 2 (Day 1): pre-dose, 1 hour, 2 hours and 3.5 hours post-dose, Visit 3 (Day 2)-post acute, Visit 4 (Day 16)-rescreen, Visit 5 (Day 23)-Baseline chronic and end of treatment (14 days after Visit 5) or early termination (between Visit 2 and 6)|Pharmacokinetic concentration Population. Only those participants available at the specified time points were analyzed.||Nanogram x hour/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
854740|NCT02135848|Secondary|Derived Plasma GSK1278863 Pharmacokinetic Parameter- Maximum Plasma Concentration (Cmax) and Trough Concentration (Ctau)|Blood samples for pharmacokinetic analysis of GSK1278863 and selected metabolites were collected at the following time points: Visit 2-Baseline acute: pre-dose, 1 hour, 2 hours and 3.5 hours post-dose, Visit 3-post acute, Visit 4-rescreen, Visit 5-Baseline chronic and end of treatment or early termination. The actual date and time of each blood sample collection was recorded.|Visit 2 (Day 1): pre-dose, 1 hour, 2 hours and 3.5 hours post-dose, Visit 3 (Day 2)-post acute, Visit 4 (Day 16)-rescreen, Visit 5 (Day 23)-Baseline chronic and end of treatment (14 days after Visit 5) or early termination (between Visit 2 and 6)|Pharmacokinetic concentration population comprised of all participants from whom a pharmacokinetic sample had been obtained and analyzed. Only those participants available at the specified time points were analyzed.||Nanogram/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
854741|NCT02135848|Secondary|Change From Baseline in Lipids (Total Cholesterol [TC], Triglycerides [TG], High Density Lipoprotein Cholesterol [HDLc] and Low Density Lipoprotein Cholesterol [LDLc])|Blood samples for analysis of fasting levels of lipid panel (TC, TG, HDLc and LDLc) was collected up to end of treatment or early termination. Baseline acute was Day 1 and Baseline chronic was Day 21. Change from Baseline was post-Baseline values minus Baseline values.|Baseline (Day 1) to Day 39|Pharmacodynamic population. Only those participants available at the specified time points were analyzed.||Millimoles/Liter (MMOL/L)||Standard Deviation|Mean
854742|NCT02135848|Secondary|Change From Baseline in High Sensitivity C-reactive Protein (hsCRP)|Blood samples for analysis of fasting levels of hsCRP, was collected up to end of treatment or early termination. Baseline acute was Day 1 and Baseline chronic was Day 21. Change from Baseline was post-Baseline values minus Baseline values.|Baseline (Day 1) to Day 39|Pharmacodynamic population. Only those participants available at the specified time points were analyzed.||Milligrams/Liter (mg/L)||Standard Deviation|Mean
854743|NCT02135848|Secondary|Change From Baseline in Hematocrit|Blood samples for analysis of fasting levels of hematocrit was collected up to end of treatment or early termination. Baseline acute was Day 1 and Baseline chronic was Day 21. Change from Baseline was post-Baseline values minus Baseline values.|Baseline (Day 1) to Day 39|Pharmacodynamic population. Only those participants available at the specified time points were analyzed.||Fraction||Standard Deviation|Mean
854744|NCT02135848|Secondary|Change From Baseline in Hemoglobin|Blood samples for analysis of fasting levels of hemoglobin was collected up to end of treatment or early termination. Baseline acute was Day 1 and Baseline chronic was Day 21. Change from Baseline was post-Baseline values minus Baseline values.|Baseline (Day 1) to Day 39|Pharmacodynamic population. Only those participants available at the specified time points were analyzed.||Grams per Liter||Standard Deviation|Mean
854745|NCT02135848|Secondary|Change From Baseline in Erythropoietin Concentration|Blood samples for analysis of fasting levels of erythropoietin, was collected up to end of treatment or early termination. Baseline acute was Day 1 and Baseline chronic was Day 21. Change from Baseline was post-Baseline values minus Baseline values.|Baseline (Day 1) to Day 39|Pharmacodynamic Population. Only those participants available at the specified time points were analyzed.||Units per Liter||Standard Deviation|Mean
854746|NCT02135848|Secondary|Change From Baseline in the Maximal Distance Covered During a Six-Minute Walk Test|The Six-Minute Walk Test was performed by the participant walking at a self-selected pace for 6 minutes through a pre-defined walking course. When the Six-Minute Walk Test and Bilateral Heel Raise Test were conducted at the same study visit, the participant was allowed to rest a minimum of one hour between these tests. Baseline was Day 1. Change from Baseline was post-Baseline values minus Baseline values.|Baseline (Day 1) to Day 39|Pharmacodynamic Population. Only those participants available at the specified time points were analyzed.||Feet||Standard Deviation|Mean
854747|NCT02135848|Secondary|Change From Baseline in Total Exercise Time to Claudication-limited Maximal Muscle Performance|BHRT is a method to assess muscle performance in participants with claudication. Participants with PAD and claudication experience reproducible symptoms of leg pain during walking exercise. The symptom of claudication is due to exercise-induced ischemia of muscles in legs, most commonly in calf muscles. At Visit 1 (-21 to -10 days), the participant was introduced to the BHRT. Test familiarization consisted of the participant performing heel raises to the onset of claudication. The BHRT was conducted with an electrogoniometer instrumented on the index leg (the leg that met the inclusion symptomatic and hemodynamic criteria [ABI ≤ 0.90] with the lowest ABI considered if both legs were affected). Successive heel raise repetitions were performed once every other second until the participant stopped due to intolerable claudication pain or fatigue, or other criteria for stopping the test were met. Baseline was Day 1. Change from Baseline was post-Baseline values minus Baseline values.|Baseline (Day 1) to Day 39|Pharmacodynamic population. Only those participants available at the specified time points were analyzed.||seconds||Standard Deviation|Mean
854748|NCT02135848|Secondary|Change From Baseline in Total Work Performed to Claudication-limited Maximal Muscle Performance|BHRT is a method to assess muscle performance in participants with claudication. Participants with PAD and claudication experience reproducible symptoms of leg pain during walking exercise. The symptom of claudication is due to exercise-induced ischemia of muscles in legs, most commonly in calf muscles. At Visit 1 (-21 to -10 days), the participant was introduced to the BHRT. Test familiarization consisted of the participant performing heel raises to the onset of claudication. The BHRT was conducted with an electrogoniometer instrumented on the index leg (the leg that met the inclusion symptomatic and hemodynamic criteria [ABI ≤ 0.90] with the lowest ABI considered if both legs were affected). Successive heel raise repetitions were performed once every other second until the participant stopped due to intolerable claudication pain or fatigue, or other criteria for stopping the test were met. Baseline was Day 1. Change from Baseline was post-Baseline values minus Baseline values.|Baseline (Day 1) to Day 39|Pharmacodynamic population. Only those participants available at the specified time points were analyzed.||kilogram-meters||Standard Deviation|Mean
854749|NCT02135848|Secondary|Change From Baseline in Total Number of Contractions to Claudication-limited Maximal Muscle Performance|BHRT is a method to assess muscle performance in participants with claudication. Participants with PAD and claudication experience reproducible symptoms of leg pain during walking exercise. The symptom of claudication is due to exercise-induced ischemia of muscles in legs, most commonly in calf muscles. At Visit 1 (-21 to -10 days), the participant was introduced to the BHRT. Test familiarization consisted of the participant performing heel raises to the onset of claudication. The BHRT was conducted with an electrogoniometer instrumented on the index leg (the leg that met the inclusion symptomatic and hemodynamic criteria [ABI ≤ 0.90] with the lowest ABI considered if both legs were affected). Successive heel raise repetitions were performed once every other second until the participant stopped due to intolerable claudication pain or fatigue, or other criteria for stopping the test were met. Baseline was Day 1. Change from Baseline was post-Baseline values minus Baseline values.|Baseline (Day 1) to Day 39|Pharmacodynamic population. Only those participants available at the specified time points were analyzed.||Contractions||Standard Deviation|Mean
854750|NCT02135848|Secondary|Change From Baseline in Total Exercise Time to Onset of Claudication|BHRT is a method to assess muscle performance in participants with claudication. Participants with PAD and claudication experience reproducible symptoms of leg pain during walking exercise. The symptom of claudication is due to exercise-induced ischemia of muscles in legs, most commonly in calf muscles. At Visit 1 (-21 to -10 days), the participant was introduced to the BHRT. Test familiarization consisted of the participant performing heel raises to the onset of claudication. The BHRT was conducted with an electrogoniometer instrumented on the index leg (the leg that met the inclusion symptomatic and hemodynamic criteria [ABI ≤ 0.90] with the lowest ABI considered if both legs were affected). Successive heel raise repetitions were performed once every other second until the participant stopped due to intolerable claudication pain or fatigue, or other criteria for stopping the test were met. Baseline was Day 1. Change from Baseline was post-Baseline values minus Baseline values.|Baseline (Day 1) to Day 39|Pharmacodynamic population. Only those participants available at the specified time points were analyzed.||Seconds||Standard Deviation|Mean
854751|NCT02135848|Secondary|Change From Baseline in Total Work Performed to Onset of Claudication|BHRT is a method to assess muscle performance in participants with claudication. Participants with peripheral artery disease (PAD) and claudication experience reproducible symptoms of leg pain during walking exercise. The symptom of claudication is due to exercise-induced ischemia of muscles in legs, most commonly in calf muscles. At Visit 1 (-21 to -10 days), the participant was introduced to BHRT. Test familiarization consisted of the participant performing heel raises to onset of claudication. BHRT was conducted with an electrogoniometer instrumented on the index leg (leg that met the inclusion symptomatic and hemodynamic criteria [ABI ≤ 0.90] with the lowest ABI considered if both legs were affected). Successive heel raise repetitions were performed once every other second until participant stopped due to intolerable claudication pain/fatigue, or other criteria for stopping the test were met. Baseline was Day 1. Change from Baseline was post-Baseline values minus Baseline values.|Baseline (Day 1) to Day 39|Pharmacodynamic population. Only those participants available at the specified time points were analyzed.||kilogram-meters||Standard Deviation|Mean
854752|NCT02135848|Secondary|Change From Baseline in Total Number of Contractions to Onset of Claudication|At Visit 1 (-21 to -10 days), the participant was introduced to the bilateral heel raise test (BHRT). Test familiarization consisted of the participant performing heel raises to the onset of claudication. The BHRT was conducted with an electrogoniometer instrumented on the index leg. Successive heel raise repetitions were performed once every other second until the participant stopped due to intolerable claudication pain or fatigue, or other criteria for stopping the test were met. The index leg was defined as the leg that met the inclusion symptomatic and hemodynamic criteria (ankle brachial index [ABI] ≤ 0.90) with the lowest ABI considered if both legs were affected. Baseline was Day 1. Change from Baseline was post-Baseline values minus Baseline values.|Baseline (Day 1) to Day 39|Pharmacodynamic population comprised of all participants who provided pharmacodynamic data, i.e. bilateral heel-raise data or six-minute-walk-test data. Only those participants with data available at the indicated time points were analyzed.||Contractions||Standard Deviation|Mean
854753|NCT02135848|Primary|Number of Participants With Clinical Hematology Abnormalities of Potential Clinical Importance|Hematology parameters included platelet count, red blood cell (RBC) count, white blood cell WBC count (absolute), hemoglobin, hematocrit, Mean corpuscular volume (MCV), Mean corpuscular hemoglobin (MCH), Mean corpuscular hemoglobin concentration (MCHC), neutrophils, lymphocytes, monocytes, eosinophils and basophils. Number of participants with clinical hematology abnormalities of potential clinical importance are presented.|Up to 67 days|Safety Population.||Participants|||Count of Participants
854754|NCT02135848|Primary|Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance|Clinical chemistry analyte of potential clinical concern included albumin, calcium, creatinine, glucose, magnesium, phosphorus, potassium, sodium and bicarbonate. Number of participants with clinical chemistry abnormalities of potential clinical importance are presented.|Up to 67 days|Safety Population.||Participants|||Count of Participants
854755|NCT02135848|Primary|Number of Participants With Vital Signs of Potential Clinical Importance|Vital signs included heart rate, systolic and diastolic blood pressure and were performed with the participant in a supine position after the participant had rested for at least 5 minutes. Number of participants with vital signs of potential clinical importance are presented.|Up to 39 days|Safety Population.||Participants|||Count of Participants
854756|NCT02135848|Primary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings|Twelve lead ECGs were recorded with the participant lying supine, having rested in this position for at least 5 minutes before each recording. Full 12 lead ECGs were recorded using an ECG device that automatically calculated the heart rate and measured PR, QRS, RR, QT and QT, QT corrected by Bazett's formula (QTcB) and QT corrected by Fridericia's formula (QTcF) intervals. Number of participants with abnormal (not clinically significant [NCS] and clinically significant [CS]) ECG findings are presented.|Up to 39 days|Safety Population. Only those participants with data available at the indicated time points were analyzed.||Participants|||Count of Participants
854757|NCT02135848|Primary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant.|Up to 67 days|Safety population which comprised of all participants who received at least one dose of study medication.||Participants|||Count of Participants
854758|NCT02108977|Primary|Cost Analysis|Labor (including training) and non-labor (e.g., equipment cost) inputs required to provide counseling via telephone versus videoconferencing. Patient travels costs will be included via self-report.|Cost analysis will be conducted in months 10-12 of grant period (projected January 1-March 31, 2015)|||Loss of Productivity Cost in US Dollars||Inter-Quartile Range|Median
854759|NCT02108977|Primary|Qualitative Assessment of Genetic Counseling Experience, Barriers and Facilitators by GENETIC COUNSELORS|Five counselors agreed to be interviewed. We asked them to discuss specific aspects of each modality including the ease of use, navigation, and adaptability of each modality, conveying and comprehending genetic and numeric information, and perceived advantages and disadvantages of each modality.|Within 4 weeks after study data collection was completed||||||
854760|NCT02108977|Primary|Qualitative Assessment of Genetic Counseling Experience, Barriers and Facilitators by PATIENTS|We asked the subjects to discuss specific aspects of each modality including the ease of use, navigation, and adaptability of each modality, conveying and comprehending genetic and numeric information, and perceived advantages and disadvantages of each modality.|Within six weeks of receiving genetic counseling|A subsample of patients in each modality was interviewed to qualitatively assess the satisfaction with the counseling they received, and the benefits and limitations of the modality, whether it was by phone or video.||participants|||Number
854761|NCT02108977|Primary|Satisfaction With Genetic Counseling Session Using the Genetic Counseling Satisfaction Scale|6-question Genetic Counseling Satisfaction Scale using 5-point Likert scale responses Strongly Disagree (1) to Strongly Agree (5)|Within two weeks of receiving genetic counseling|||points on a scale of 30 (most satisfied)||Standard Deviation|Mean
854762|NCT02108977|Primary|Assessment of Knowledge Retention of Genetic Counseling Information Via 8-Question Pre- and Post-Counseling Assessment|Subjects will be asked 8 True/False genetics-related questions before and after counseling to assess improvement and retention of genetic counseling knowledge and information|Pre- and post- (within 2 weeks) genetic counseling|||Number of correct answers (out of 8)||Standard Deviation|Mean
854763|NCT02105324|Secondary|Percentage of Participants Using Pramlintide During the Usual Care Period|The percentage of participants who used pramlintide to manage their diabetes during the Usual Care period.|5 days|All participants who completed both periods of the study. Results are reported for the Usual Care period only.||percentage of participants|||Number
854764|NCT02105324|Secondary|Percentage of Participants Using a Glucagon-Like Peptide-1 (GLP-1) Agonist During the Usual Care Period|The percentage of participants who used a GLP-1 agonist to manage their diabetes during the Usual Care period.|5 days|All participants who completed both periods of the study. Results are reported for the Usual Care period only.||percentage of participants|||Number
854765|NCT02105324|Secondary|Number of Unscheduled CGM Sensor Changes|The number of time a CGM sensor was replaced due to falling out or failing to report a glucose value.|5 days|All randomized participants who completed both periods of the study.||CGM sensor changes|||Number
854766|NCT02105324|Secondary|List of Technical Faults Associated With the Bionic Pancreas Including Cause and Resolution||5 days|Data was not collected and analyzed to this level of detail.|||||
854767|NCT02105324|Secondary|Reliability Index|Reliability index was calculated as the percentage of time values were actually recorded by CGM.|Day 1, Days 1-5, and Days 2-5 in each period|All randomized participants who completed both periods of the study.||percentage of time||Standard Deviation|Mean
854768|NCT02105324|Secondary|Change From Baseline in Body Weight|The change in body weight collected at Day 5 of each period relative to Baseline. A negative change from Baseline indicates a reduction in body weight and a positive change from Baseline indicates an increase in body weight.|5 days|All randomized participants who completed both periods of the study.||kg||Standard Deviation|Mean
854769|NCT02105324|Secondary|Percentage of Time Without CGM Monitoring Data|Percentage of time without CGM monitoring data is the time when the participant's CGM device lost its CGM signal.|5 days|All randomized participants who completed both periods of the study.||percentage of time||Standard Deviation|Mean
854770|NCT02105324|Secondary|Percentage of Time Participants Were Not Under Bionic Pancreas Control During the Bionic Pancreas Period|Percentage of time that the Bionic pancreas was not functioning properly due to loss of wireless connectivity.|5 days|All randomized participants who completed both periods of the study. Reported for the Bionic Pancreas period only.||percentage of time||Standard Deviation|Mean
854771|NCT02105324|Secondary|Number of Severe Hypoglycemic Events|A severe hypoglycemic event is an event where the participant is unable to self-treat and requires the assistance of another person.|Day 1, Days 1-5 and Days 2-5|All randomized participants who completed both periods of the study.||severe hypoglycemic events|||Number
854971|NCT00625404|Primary|Confirmed Grade 3 or Higher ALT Elevation|Grade 3 or higher ALT elevation was defined as ≥ 2.6 times the upper limit of normal|Through 52 weeks on product and 4 weeks post-product|||participants|||Number
854773|NCT02105324|Secondary|Number of Bionic Pancreas Local Infusion Site Reactions|Local infusion site reactions are defined as pain at the infusion site of the Bionic Pancreas. Itching and redness may have also been present.|Day 1, Days 1-5 and Days 2-5|All randomized participants who completed both periods of the study. Results are reported for the Bionic Pancreas period only.||infusion site reactions|||Number
854774|NCT02105324|Secondary|Number of Unscheduled Infusion Set Changes|Infusion sets for administering insulin and glucagon were placed under the skin the in the abdomen, buttocks, arms, or legs. Infusion set changes due to pain, infusion set falling out or infusion set failure are reported. Camp policy was to suspect failure of the infusion set whenever ketonemia occurred, so failures may not have actually been set failures, but rather failure to deliver enough insulin.|Days 2-5|All randomized participants who completed both periods of the study.||unscheduled infusion set changes|||Number
854775|NCT02105324|Secondary|Number of Unscheduled Infusion Set Changes|Infusion sets for administering insulin and glucagon were placed under the skin the in the abdomen, buttocks, arms, or legs. Infusion set changes due to pain, infusion set falling out or infusion set failure are reported. Camp policy was to suspect failure of the infusion set whenever ketonemia occurred, so failures may not have actually been set failures, but rather failure to deliver enough insulin.|Days 1-5|All randomized participants who completed both periods of the study.||unscheduled infusion set changes|||Number
854776|NCT02105324|Secondary|Number of Unscheduled Infusion Set Changes|Infusion sets for administering insulin and glucagon were placed under the skin the in the abdomen, buttocks, arms, or legs. Infusion set changes due to pain, infusion set falling out or infusion set failure are reported. Camp policy was to suspect failure of the infusion set whenever ketonemia occurred, so failures may not have actually been set failures, but rather failure to deliver enough insulin.|Day 1|All randomized participants who completed both periods of the study.||unscheduled infusion set changes|||Number
854777|NCT02105324|Secondary|Carbohydrate Intake|Carbohydrate intake included meals, snacks and unscheduled carbohydrates administered when a participant's blood glucose was <80 mg/dl (or for symptoms at any glucose level). Carbohydrate intake per day was averaged and is reported in grams (g) per kilogram (kg) per day (g/kg/day).|Day 1, Days 1-5 and Days 2-5|All randomized participants who completed both periods of the study.||g/kg/day||Standard Deviation|Mean
854778|NCT02105324|Secondary|Daily Bolus Insulin Dose in the Bionic Pancreas Period|The first time the bionic pancreas was used in each participant, a partial meal-priming bolus based on the participant’s body mass (0.05 units/kg) was delivered. After the first use, the size of the meal-priming bolus was adapted by the bionic pancreas to 75% of the 4-hour prandial insulin used for that meal type and size. Daily bolus insulin dose is reported in units per kilogram (kg) per day (U/kg).|Day 1 through Day 5|All participants who completed both periods of the study. Results are reported for the Bionic Pancreas period only.||U/kg/day||Standard Deviation|Mean
854779|NCT02105324|Secondary|Daily Basal Insulin Dose in the Bionic Pancreas Period|The bionic pancreas automatically adapted insulin dosing to each individual’s needs. When CGM data were not available (because of sensor failure or during the warm-up time after sensor replacement), the bionic pancreas automatically delivered a dose of basal insulin based on the mean basal dosing it had calculated at that time on previous days. Daily basal insulin dose is reported in units per kilogram (kg) per day (U/kg).|Day 1 through Day 5|All participants who completed both periods of the study. Results are reported for the Bionic Pancreas period only.||U/kg/day||Standard Deviation|Mean
854780|NCT02105324|Secondary|Glucagon Total Daily Dose Levels in the Bionic Pancreas Arm|Glucagon dose level is reported in micrograms per kilogram of body mass per day (µg/kg/day).|Day 1, Days 1-5, and Days 2-5 of each period|All participants who completed both periods of the study. Results are reported for the Bionic Pancreas period only.||µg/kg/day||Standard Deviation|Mean
854781|NCT02105324|Secondary|Insulin Total Daily Dose|Insulin total daily dose is reported in units per kilogram per day (U/kg/day).|11 days|All randomized participants who completed both periods of the study.||U/kg/day||Standard Deviation|Mean
854782|NCT02105324|Secondary|Grams of Carbohydrate Taken for Hypoglycemia When Plasma Glucose <70 mg/dL|Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). Participants were given 15 grams (g) of simple carbohydrates if their plasma glucose concentration dropped below 4.4 mmol/L. These simple carbohydrates were counted as interventions for study outcomes if the plasma glucose concentration was less than 3.9 mmol/L. A second intervention of 15 g of carbohydrate was given if a repeat measurement in 15–20 min was less than 3.9 mmol/L.|Day 1, Days 1-5, and Days 2-5 of each period|All randomized participants who completed both periods of the study.||grams of carbohydrate||Full Range|Median
854783|NCT02105324|Secondary|Number of Carbohydrate Interventions for Hypoglycemia When Plasma Glucose <70 mg/dL|Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). Participants were given 15 grams (g) of simple carbohydrates if their plasma glucose concentration dropped below 4.4 mmol/L. These simple carbohydrates were counted as interventions for study outcomes if the plasma glucose concentration was less than 3.9 mmol/L. A second intervention of 15 g of carbohydrate was given if a repeat measurement in 15-20 min was less than 3.9 mmol/L. The total number of carbohydrate interventions are reported.|Day 1, Days 1-5, and Days 2-5 of each period|All randomized participants who completed both periods of the study.||carbohydrate interventions||Full Range|Median
854784|NCT02105324|Secondary|Percentage of Days That CGM Data Was Used by Participants as Part of Their Usual Care|The percentage of days during the Usual Care period that participants used CGM data as part of their diabetes management.|Day 1, Days 1-5, and Days 2-5 of the Usual Care Period|All randomized participants who completed both periods of the study.||percentage of days|||Number
854785|NCT02105324|Secondary|Number of Plasma Glucose Reported Hypoglycemic Events (< 70 mg/dL, < 60 mg/dL, <50 mg/dL)|A series of hypoglycemic measurements is defined as a single event until there is a break of ≥ 30 minutes between measurements below the defined thresholds of < 70, < 60, and <50 mg/dL.|Days 1-5|||times below threshold||Standard Deviation|Mean
854786|NCT02105324|Secondary|Percentage of Participants With Mean Plasma Glucose <183 mg/dL|Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). The plasma glucose readings were averaged. 183 mg/dL was the estimated average glucose corresponding to a Hemoglobin A1C of 8.0%.|Day 1, Days 1 to 5, and Days 2 to 5 of each period|All randomized participants who completed both periods of the study.||percentage of participants|||Number
854787|NCT02105324|Secondary|Percentage of Participants With Mean Plasma Glucose <169 mg/dL|Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). The plasma glucose readings were averaged. 169 mg/dL was the estimated average glucose corresponding to a Hemoglobin A1C of 7.5%.|Day 1, Days 1 to 5, and Days 2 to 5 of each period|All randomized participants who completed both periods of the study.||percentage of participants|||Number
854788|NCT02105324|Secondary|Percentage of Participants With Mean Plasma Glucose <154 mg/dL|Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). The plasma glucose readings were averaged. 154 mg/dL was the estimated average glucose corresponding to a Hemoglobin A1C of 7.0%.|Day 1, Days 1 to 5, and Days 2 to 5 of each period|All randomized participants who completed both periods of the study.||percentage of participants|||Number
854789|NCT02105324|Secondary|Percentage of Time With Plasma Glucose Values by Ranges on Days 2 to 5|Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). The percentage of time that the plasma glucose concentration was less than the following ranges were calculated: < 70 mg/dl (3.9 mmol/L), < 60 mg/dL (3.3 mmol/L), < 50 mg/dl (2.8 mmol/L).|Days 2 to 5 of each period|All randomized participants who completed both periods of the study.||percentage of values||Standard Deviation|Mean
854790|NCT02105324|Secondary|Percentage of Time With Plasma Glucose Values by Ranges on Days 1 to 5|Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). The percentage of time that the plasma glucose concentration was less than the following ranges were calculated: < 70 mg/dL (3.9 mmol/L), < 60 mg/dL (3.3 mmol/L), < 50 mg/dL (2.8 mmol/L).|Days 1 to 5 of each period|All randomized participants who completed both periods of the study.||percentage of values||Standard Deviation|Mean
854791|NCT02105324|Secondary|Percentage of Time With Plasma Glucose Values by Ranges on Day 1|Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). The percentage of time that the plasma glucose concentration was less than the following ranges were calculated: < 70 mg/dl (3.9 mmol/L), < 60 mg/dL (3.3 mmol/L), < 50 mg/dl (2.8 mmol/L).|Day 1 of each period|All randomized participants who completed both periods of the study.||percentage of values||Standard Deviation|Mean
854792|NCT02105324|Secondary|Mean Plasma Glucose Values|Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). The plasma glucose readings were averaged. The plasma glucose results on Day 1, Days 1 to 5 and Days 2 to 5 were averaged.|Day 1, Days 1 to 5, and Days 2 to 5 of each period|All randomized participants who completed both periods of the study.||mg/dL||Standard Deviation|Mean
854793|NCT02105324|Secondary|Number of CGMG Reported Hypoglycemic Events (< 70 mg/dL, < 60 mg/dL, <50 mg/dL)|A series of hypoglycemic measurements is defined as a single event until there is a break of ≥ 30 minutes between measurements below the defined thresholds of < 70, < 60, and <50 mg/dL.|Days 1-5|||times below threshold||Standard Deviation|Mean
854794|NCT02105324|Secondary|Percentage of Participants With Mean CGMG Glucose <183 mg/dL|Glucose reading were taken every 5 minutes by the CGM. The glucose readings were averaged. 183 mg/dL was the estimated average glucose corresponding to a Hemoglobin A1C of 8.0%.|Day 1, Days 1-5, and Days 2-5 of each period|All randomized participants who completed both periods of the study.||percentage of participants|||Number
854795|NCT02105324|Secondary|Percentage of Participants With Mean CGMG Glucose <169 mg/dL|Glucose reading were taken every 5 minutes by the CGM. The glucose readings were averaged. 169 mg/dL was the estimated average glucose corresponding to a Hemoglobin A1C of 7.5%.|Day 1, Days 1-5, and Days 2-5 of each period|All randomized participants who completed both periods of the study.||percentage of participants|||Number
854796|NCT02105324|Secondary|Percentage of Participants With Mean CGMG Glucose <154 mg/dL|Glucose reading were taken every 5 minutes by the CGM. The glucose readings were averaged. 154 mg/dL was the estimated average glucose corresponding to a Hemoglobin A1C of 7.0%.|Day 1, Days 1-5, and Days 2-5 of each period|All randomized participants who completed both periods of the study.||percentage of participants|||Number
854797|NCT02105324|Secondary|Percentage of Time With CGMG Concentration by Ranges During Days 2 to 5|Glucose readings were taken every 5 minutes by the CGM. The percentage of time that the glucose concentration was less than the following ranges were calculated: < 50 mg/dl (2.8 mmol/L), < 70 mg/dl (3.9 mmol/L), 70-180 mg/dl (3.9 to 10.0 mmol/L), > 180 mg/dL (10.0 mmol/L).|Days 2 to 5 of each period|All randomized participants who completed both periods of the study.||percentage of time||Standard Deviation|Mean
854798|NCT02105324|Secondary|Percentage of Time With CGMG Concentration by Ranges During Days 1 to 5|Glucose readings were taken every 5 minutes by the CGM. The percentage of time that the glucose concentration was less than the following ranges were calculated: < 50 mg/dl (2.8 mmol/L), < 70 mg/dl (3.9 mmol/L), 70-180 mg/dl (3.9 to 10.0 mmol/L), > 180 mg/dL (10.0 mmol/L).|Days 1 to 5 of each period|All randomized participants who completed both periods of the study.||percentage of time||Standard Deviation|Mean
854799|NCT02105324|Secondary|Percentage of Time With CGMG Concentration by Ranges During Day 1|Glucose readings were taken every 5 minutes by the CGM. The percentage of time that the glucose concentration was less than the following ranges were calculated: < 50 mg/dL(2.8 mmol/L), < 70 mg/dL (3.9 mmol/L), 70-180 mg/dL (3.9 to 10.0 mmol/L), > 180 mg/dL (10.0 mmol/L).|Day 1 of each period|All randomized participants who completed both periods of the study.||percentage of time||Standard Deviation|Mean
854800|NCT02105324|Secondary|Mean CGMG Values|Glucose reading were taken every 5 minutes by the CGM. The glucose results for each time frame were averaged.|Day 1 and Days 1-5 in each period|All randomized participants who completed both periods of the study.||mg/dL||Standard Deviation|Mean
854801|NCT02105324|Primary|Percentage of Time Spent With CGMG Concentration < 60 mg/dL During Days 2 to 5|Glucose reading were taken every 5 minutes by the CGM. The percentage of time that the glucose concentration was less than 60 mg/dL [3.3 millimoles/liter (mmol/L)] during Days 2 through 5 was calculated.|Days 2 to 5 of each period|All randomized participants who completed both periods of the study.||percentage of time||Standard Deviation|Mean
854802|NCT02105324|Primary|Mean Continuous Glucose Monitoring Glucose (CGMG) Values During Days 2 to 5|Glucose reading were taken every 5 minutes by the CGM. The CGM glucose results during Days 2 through 5 were averaged.|Days 2 to 5 of each period|All randomized participants who completed both periods of the study.||milligrams/deciliter (mg/dL)||Standard Deviation|Mean
854803|NCT02092220|Other Pre-specified|CGM Mean Absolute Relative Differences (MARD) Versus Time-stamped Blood Glucose (BG) Values From Meter Downloads|This outcome measure compares the time stamped PG values from the glucose meter to the corresponding CGM glucose value to determine the overall accuracy of the CGM.|11 days|All randomized participants who completed both periods.||percent difference||Standard Deviation|Mean
854804|NCT02092220|Other Pre-specified|Mean Daily Bolus Insulin Dose|Daily bolus insulin dose reported in Units per kilogram per day (U/kg/day).|Day 1, Days 1 to 11, Days 2 to 11, each individual day 2 to 11 of each period|All randomized participants who completed both periods of the study.||U/kg/day||Standard Deviation|Mean
854805|NCT02092220|Other Pre-specified|Mean Daily Basal Insulin Dose|Daily basal insulin dose reported in Units per kilogram per day (U/kg/day).|Day 1, Days 2 to 11, each individual day 2 to 11 of each period|All randomized participants who completed both periods of the study.||U/kg/day||Standard Deviation|Mean
854806|NCT02092220|Other Pre-specified|Number of Unscheduled Infusion Set Replacements||11 days|All randomized participants who completed both periods of the study. Glucagon infusion sets are not applicable to the Usual Care arm.||Infusion Set Relacements|||Number
854807|NCT02092220|Other Pre-specified|Reliability Index, Calculated as Percent of Possible Values Actually Recorded by CGM||11 days|All randomized participants who completed both periods.||percentage of possible values||Standard Deviation|Mean
854808|NCT02092220|Secondary|Number of Participants With Skin Rash||11 days of each period|All randomized participants who completed both periods of the study.||Participants|||Count of Participants
854809|NCT02092220|Secondary|Change From Baseline in Hemoglobin|The change in the value of hemoglobin collected at Day 12 relative to Baseline. A negative change from Baseline indicates a reduction in hemoglobin and a positive change from Baseline indicates an increase in hemoglobin.|Baseline and Day 12 of each period|All randomized participants who completed both periods of the study.||grams/deciliter (mg/dL)||Standard Deviation|Mean
854810|NCT02092220|Secondary|Change From Baseline in Body Weight|The change in body weight collected at Day 12 relative to Baseline. A negative change from Baseline indicates a reduction in body weight and a positive change from Baseline indicates an increase in body weight.|Baseline and Day 12 of each period|All participants who completed both periods of the study.||kilograms||Standard Deviation|Mean
854811|NCT02092220|Secondary|Mean Nausea Index Score Using a Visual Analog Scale (VAS)|Participants rated their nausea using a 0 to 10 centimeter (cm) VAS where 0=least severe nausea to 10=most severe nausea. The average nausea index scores during Days 1 to 11 and Days 2 to 11 were calculated.|Day 1, Days 1 to 11, Days 2 to 11 and each individual day 2 to 11 of each period|All randomized participants who completed both periods of the study.||cm||Standard Deviation|Mean
854812|NCT02092220|Secondary|Percentage of Time Bionic Pancreas Off-line or Not Functioning Properly|Not functioning properly includes issues due to system crash, communication problems between CGM and bionic pancreas, communication problems between bionic pancreas and pumps and pump malfunction.|11 days|All randomized participants who completed both periods of the study. Reported for the Bionic pancreas arm only||percentage of time||Standard Deviation|Mean
854813|NCT02092220|Secondary|Mean Glucose Target Set by User (Time-weighted Average Over Study Period) in the Bionic Pancreas Arm||Day 1, Days 2 to 11, Days 1 to11, Overall, Daytime, Nighttime of each period|All randomized participants who completed both periods of the study.||mg/dL||Standard Deviation|Mean
854814|NCT02092220|Secondary|Glucagon Total Daily Dose Levels in the Bionic Pancreas Arm|Glucagon dose level is reported in micrograms per kilogram of body mass per day (µg/kg/day).|Day 1, Days 2 to 11, Days 1 to 11 of each period|All participants who completed both periods of the study. Results are reported for the Bionic Pancreas period only.||µg/kg/day||Standard Deviation|Mean
854815|NCT02092220|Secondary|Insulin Total Daily Dose|Insulin total daily dose is reported in units per kilogram per day (U/kg/day).|Day 1, Days 1 to 11, Days 2 to 11 of each period|All participants who completed both periods of the study.||U/kg/day||Standard Deviation|Mean
854816|NCT02092220|Secondary|Total Grams of Carbohydrate Taken for Hypoglycemia|"The total grams of carbohydrate taken for hypoglycemia as reported daily by the participant were averaged.
The total number of grams of carbohydrate taken for hypoglycemia were reported daily by the participant. The total number of grams of carbohydrate taken are reported."|Day 1, Days 1 to 11 and Days 2 to 11 of each period|All participants who completed both periods of the study.||grams of carbohydrate per day||Standard Deviation|Mean
854817|NCT02092220|Secondary|Number of Reported Carbohydrate Interventions for Hypoglycemia|The number of carbohydrate interventions for hypoglycemia were reported daily by the participant. The average number of carbohydrate interventions per day is reported.|Day 1, Days 1 to 11 and Days 2 to 11 of each period|All participants who completed both periods of the study.||interventions per day||Standard Deviation|Mean
854818|NCT02092220|Secondary|Number of Episodes of Symptomatic Hypoglycemia|The number of episodes of symptomatic hypoglycemia were reported daily by the participant. The average number of episodes of symptomatic hypoglycemia per day was calculated.|Day 1, Days 1 to 11 and Days 2 to 11 of each period|All participants who completed both periods of the study.||episodes per day||Standard Deviation|Mean
854819|NCT02092220|Secondary|Number of Participants With Severe Hypoglycemic Events|A severe hypoglycemic event is an event where the participant is unable to self-treat and requires the assistance of another person.|11 days of each period|All participants who completed both periods of the study.||Participants|||Count of Participants
854820|NCT02092220|Secondary|Anti-Insulin and Anti-Glucagon Antibodies on Day 12||Day 12 of each period|No data was collected for Anti-Insulin and Anti-Glucagon Antibodies.|||||
854821|NCT02092220|Secondary|1,5-anhydroglucitol on Day 12||Day 12 of each period|No data was collected for 1,5-anhydroglucitol.|||||
854822|NCT02092220|Secondary|Glycated Albumin on Day 12||Day 12 of each period|No data was collected for Glycated Albumin.|||||
854823|NCT02092220|Secondary|Percentage of Days That CGM Was Used by Participants as Part of Their Usual Care|The percentage of days that participants reported the CGM device was being worn and working properly is reported.|Days 1-11 of each period|All randomized participants who completed both periods of the study. This outcome measure applies only to the Usual Care arm.||percentage of days|||Number
854881|NCT01336413|Secondary|Beck Depression Inventory-II (BDI-II)|21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression. Scores range from 0 (no depression) to 63 (severe depression).|Baseline, 4 Weeks, and 8 Weeks|3 subjects in Arm 1, and 1 subject in Arm 2, withdrew prior to the final visit of the study.||Total Score||Standard Error|Mean
854824|NCT02092220|Secondary|Number of Hypoglycemic Events (< 70 mg/dL, < 60 mg/dL, <50 mg/dL)|A series of hypoglycemic measurements is defined as a single event until there is a break of ≥ 30 minutes between measurements below the defined thresholds of < 70, < 60, and <50 mg/dL. This outcome measure was not calculated. As the study progressed, the principal investigator determined that this particular analysis would not adequately reflect the amount of hypoglycemia subjects experienced and would not be a clinically significant result. This outcome measure was not calculated. Our co-primary outcome, #2, and other secondary outcomes, #4 5 and 6, are more valid and clinically relevant measures of hypoglycemia.Those outcomes quantify the amount of time subjects spent below each hypoglycemic threshold, which better reflects the degree of risk exposure the subjects experienced related to hypoglycemia. The number of times the CGM crosses below the hypoglycemia threshold, which is what this outcome measures, is a less relevant piece of information per the principal investigator.|Days 1-11|||times below threshold||Standard Deviation|Mean
854825|NCT02092220|Secondary|Percentage of Participants With Mean CGMG < 154 mg/dl|Glucose reading were taken every 5 minutes by the CGM. The glucose readings were averaged. 154 mg/dL was the estimated average glucose corresponding to a Glycosylated Hemoglobin A1C of 7%.|Day 1, Days 2 to11, Days 1 to11 of each period|All randomized participants who completed both periods of the study.||percentage of participants|||Number
854826|NCT02092220|Secondary|Percentage of Time With CGMG Concentration by Ranges During Days 2 to 11|"Glucose reading were taken every 5 minutes by the CGM.The percentage of time that the glucose concentration was less than the following ranges were calculated:
< 50 mg/dL (2.8 mmol/L) < 70 mg/dL (3.9 mmol/L) 70 to 120 mg/dL (3.9 to 6.7 mmol/L) 70 to180 mg/dl (3.9 to 10.0 mmol/L) > 180 mg/dL (10.0 mmol/L) > 250 mg/dL (13.9 mmol/L)"|Days 2 to 11 of each period|All randomized participants who completed both periods of the study.||percentage of time||Standard Deviation|Mean
854827|NCT02092220|Secondary|Percentage of Time With CGMG Concentration by Ranges During Days 1 to 11|"Glucose reading were taken every 5 minutes by the CGM.The percentage of time that the glucose concentration was less than the following ranges were calculated:
< 50 mg/dL (2.8 mmol/L) < 70 mg/dL (3.9 mmol/L) 70 to 120 mg/dL (3.9 to 6.7 mmol/L) 70 to180 mg/dl (3.9 to 10.0 mmol/L) > 180 mg/dL (10.0 mmol/L) > 250 mg/dL (13.9 mmol/L)"|Days 1 to 11 of each period|All randomized participants who completed both periods of the study.||percentage of time||Standard Deviation|Mean
854828|NCT02092220|Secondary|Percentage of Time With CGMG Concentration by Ranges During Day 1|"Glucose reading were taken every 5 minutes by the CGM.The percentage of time that the glucose concentration was less than the following ranges were calculated:
< 50 mg/dL (2.8 mmol/L) < 60 mg/dL (3.3 mmol/L) < 70 mg/dL (3.9 mmol/L) 70 to 120 mg/dL (3.9 to 6.7 mmol/L) 70 to180 mg/dl (3.9 to 10.0 mmol/L) > 180 mg/dL (10.0 mmol/L) > 250 mg/dL (13.9 mmol/L)"|Day 1 of each period|All randomized participants who completed both periods of the study.||percentage of time||Standard Deviation|Mean
854829|NCT02092220|Secondary|Mean CGMG Values|Glucose reading were taken every 5 minutes by the CGM. The glucose results on Days 1 and Days 1 to 11 were averaged.|Day 1 and Days 1 to 11 in each period|All randomized participants who completed both periods of the study.||mg/dL||Standard Deviation|Mean
854830|NCT02092220|Primary|Percentage of Time Spent With CGMG Concentration < 60 mg/dL During Days 2 to 11|Glucose reading were taken every 5 minutes by the CGM.The percentage of time that the glucose concentration was less than 60 mg/dL [3.3 millimoles/liter (mmol/L)] during Days 2 to 11 was calculated.|Days 2 to 11 of each period|All randomized participants who completed both periods of the study.||percentage of time||Standard Deviation|Mean
854831|NCT02092220|Primary|Mean Continuous Glucose Monitoring Glucose (CGMG) Values During Days 2 to 11|Glucose reading were taken every 5 minutes by the CGM. The glucose results on Days 2 to 11 were averaged.|Days 2 to 11 of each period|All randomized participants who completed both periods of the study.||milligrams/deciliter (mg/dL)||Standard Deviation|Mean
854832|NCT02037607|Primary|Number of Participants With Post-operative Ultrasound Without Evidence of Thromboembolism|The number of participants with post-operative ultrasound without evidence of thromboembolism|within 72 hours after surgery|||Participants|||Count of Participants
854833|NCT01939223|Secondary|Overall Survival (OS)|Overall survival (OS) is defined as the time (days) from randomization to death due to any cause. The OS time for subjects alive at the time of analysis was censored at their last date known to be alive.|Subjects who experienced disease recurrence (either during treatment or during Active Follow-up), or otherwise withdrew from the study for any reason other than death, were followed for overall survival unless consent was withdrawn.|Number of Participants Analyzed is 0 because this study was prematurely terminated and data were not collected for this endpoint.|||||
854834|NCT01939223|Primary|Disease Free Survival (DFS) as Assessed by the Investigator|Disease free survival was evaluated by CT / MRI scans as assessed by the investigator, which was defined as the time (in days) from date of randomization to date of first observed radiographic disease recurrence (RECIST 1.1 criteria for measurable and non-measurable disease) or death due to any cause, if death occurred before disease recurrence was documented. For subjects without documented disease recurrence or death at the time of analysis, the DFS time was censored at the date of the last evaluable CT / MRI scan.|From date of randomization to date of first observed radiographic disease recurrence (RECIST 1.1 criteria for measurable and non-measurable disease) or death due to any cause, if death occurred before disease recurrence was documented.|Number of Participants Analyzed is 0 because this study was prematurely terminated and data were not collected for this endpoint.|||||
854835|NCT01938573|Secondary|Incidence of Adverse Events Including Any Unfavorable and Unintended Sign, Symptom, Diagnosis, or Disease Temporally Associated With the Use of a Medicinal Product, Whether or Not Related to the Medicinal Product (Phase I and II)|Graded according to the NCI CTCAE version 4.0. Safety will be assessed through summaries of adverse events, vital signs, physical examinations, and clinical laboratory test data (including change from baseline). All adverse events resulting in discontinuation, dose modification, dosing interruption, and/or treatment delay of study drug will also be listed and tabulated by preferred term.|Up to 28 days after completion of study treatment|||Number of events|||Number
854836|NCT01938573|Primary|Percent of Patients With Pathologic Complete Response (Phase II)|The study will follow an optimal two-stage Simon design based on pathologic complete response rate.|12 weeks|Patients treated in phase 2||Participants|||Count of Participants
854837|NCT01938573|Primary|Patients With Dose Limiting Toxicity|Safety will be assessed through summaries of adverse events, vital signs, physical examinations, and clinical laboratory test data (including change from baseline).|Up to 28 days|||Participants|||Count of Participants
854838|NCT01916824|Primary|Money Earned|"Change in amount of money earned between baseline and after 6 weeks of antidepressant treatment is determined through a summary score from a variety of decision-making tasks. Participants received between $5 and $40 per visit, depending on the outcomes of the decisions made on the computerized tasks. Variable payment ensured that the decision-making tasks were approached realistically, as opposed to using hypothetical “points” that do not have meaning in the real world. Greater earnings indicate better financial decision-making.
The specific tasks were:
risk task
balloon analogue risk task
temporal discounting task
ultimatum game
continuous performance task"|Baseline, Week 6|The population at each time point includes the number of participants completing the each visit.||US Dollars||Standard Deviation|Mean
854845|NCT01748890|Primary|The Number of Core Biopsies in These Targeted Regions|From elastography-prostatectomy pathology correlation, the following data will be obtained, 1) The number of planned core biopsies that would intersect foci of prostate carcinoma, 2) The Gleason Score that would be obtained, assuming that elastographically targeted biopsies sample the targeted region.|Participants will be followed until prostatectomy pathology is available (average 1 week)|insufficient recruitment for analysis|||||
854846|NCT01748292|Secondary|Mean Change in Central Foveal Thickness|Mean change in central foveal thickness by SD-OCT from baseline to weeks 48-57, baseline to week 104 and baseline to week 156.|12, 24, and 36 months|All participants were included in analysis. Due to participant attrition, missed visits, and variable follow-up intervals in the Treat and Extend arm, the population analyzed at each time point is equal to or smaller than the population still enrolled at that time point.||microns||Standard Error|Mean
854847|NCT01748292|Secondary|CNVM Lesion Size|CNVM lesion size at baseline, compared to baseline to weeks 24-28, baseline to weeks 48-56, baseline to weeks 72-82, baseline to week 104, baseline to weeks 128-132 and baseline to week 156, as determined by fluorescein angiography.|6, 12, 18, 24, 30, and 36 months||06/2018||||
854848|NCT01748292|Secondary|Percentage of Patients With Persistent Leakage on Fluorescein Angiography|Percentage of subjects with persistent leakage on fluorescein angiography from baseline through weeks 24-28, baseline to weeks 48-56, baseline to weeks 72-82, baseline to week 104, baseline to weeks 128- 132 and baseline to week 156.|6, 12, 18, 24, 30, and 36 months||06/2018||||
854849|NCT01748292|Secondary|Percentage of Subjects With Persistent Active Exudation on SD-OCT|Percentage of subjects with persistent active exudation on SD-OCT from baseline through weeks 48-57 (week closest to week 52), baseline through week 104 and baseline through week 156.|12, 24, and 36 months|All participants were included in analysis. Due to participant attrition, missed visits, and variable follow-up intervals in the Treat and Extend arm, the population analyzed at each time point is equal to or smaller than the population still enrolled at that time point.||Participants|||Count of Participants
854882|NCT01336413|Primary|Tower of London (Subscale Test of BAC) - PRIMARY COGNITIVE OUTCOME MEASURE|Subscale test asking subjects to determine the minimum number of moves that will be required to make convert one image of colored balls on pegs into a second different image. The test administers 20 items/images, with 2 additional items if all of the first 20 are answered correctly. Thus, scores range from 0-22, with lower scores representing greater impairment. Raw scores are converted to z scores that generally range from -3 to 3, with lower scores again representing greater impairment.|Baseline, 4 Weeks, and 8 Weeks|3 subjects in Arm 1, and 1 subject in Arm 2, withdrew prior to the final visit of the study.||z Score||Standard Error|Mean
854850|NCT01748292|Secondary|Total Number of Office Visits and Imaging Studies Performed During Study Period|Total number of office visits and imaging studies performed from baseline through weeks 24-28 (week closest to week 26), baseline through weeks 48-56 (week closest to week 52), baseline through weeks 72-82 (week closest to week 78), baseline through week 104, baseline through weeks 128-132 (week closest to week 132) and baseline through week 156|6, 12, 18, 24, 30, and 36 months|Per protocol, imaging was conducted at each study visit and is assumed to be perfectly correlated with the number of visits. Therefore, only visits were specifically analyzed. Additionally, given the high correlation between number of visits and injections administered (reported previously), this analysis was performed only at M12, M24, and M36.||scheduled visits completed|||Number
854851|NCT01748292|Secondary|Total Number of Intravitreal Injections Required|Total number of intravitreal injections required from baseline through weeks 48-57 (week closest to week 52), baseline through week 104 and baseline through week 156.|12, 24, and 36 months|All participants were included in analysis. Due to participant attrition, missed visits, and variable follow-up intervals in the Treat and Extend arm, the population analyzed at each time point is equal to or smaller than the population still enrolled at that time point.||injections||Full Range|Mean
854852|NCT01748292|Secondary|Incidence and Severity of Adverse Events (Ocular and Non-ocular)|Incidence and severity of adverse events both ocular and non-ocular|36 months|||Participants|||Count of Participants
854853|NCT01748292|Primary|Mean Change in BCVA by ETDRS Letter Score From Baseline|Mean change in Best-Corrected Visual Acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score from baseline through weeks 24-28, baseline through weeks 48-56, baseline through weeks 72-82, baseline to week 104, baseline through weeks 128-132 and baseline to week 156. The ETDRS protocol is a widely accepted international standard for macular laser photocoagulation treatment. A higher score represents better functioning. The scale ranges from 0 to 100 letters|6, 12, 18, 24, 30, and 36 months|All participants were included in analysis. Due to participant attrition, missed visits, and variable follow-up intervals in the Treat and Extend arm, the population analyzed at each time point is equal to or smaller than the population still enrolled at that time point.||ETDRS BCVA Letters||Standard Error|Mean
854854|NCT01736397|Secondary|Change in Hemoglobin Levels From Baseline to End of Treatment|The difference in hemoglobin levels between the value at the end of treatment (week 12) minus the baseline measurement.|12 Weeks|The efficacy analyses were based on the ITT population. The Intent-to-Treat (ITT) population consisted of all subjects who were randomized into the study, had a baseline laboratory value, had taken at least 1 dose of study drug, and had at least 1 post-baseline laboratory value. ANCOVA with LOCF methodology was used.||g/dL||Standard Deviation|Mean
854855|NCT01736397|Secondary|Change in Ferritin Levels From Baseline to End of Treatment|The difference in ferritin levels between the value at the end of treatment (week 12) minus the baseline measurement.|12 Weeks|The efficacy analyses were based on the ITT population. The Intent-to-Treat (ITT) population consisted of all subjects who were randomized into the study, had a baseline laboratory value, had taken at least 1 dose of study drug, and had at least 1 post-baseline laboratory value. ANCOVA with LOCF methodology was used.||ng/mL||Standard Deviation|Mean
854856|NCT01736397|Primary|Change in Serum Phosphorus Levels From Baseline to End of Treatment|The difference in serum phosphorus between the value at the end of treatment (week 12) minus the baseline measurement.|12 Weeks|The efficacy analyses were based on the ITT population. The Intent-to-Treat (ITT) population consisted of all subjects who were randomized into the study, had a baseline laboratory value, had taken at least 1 dose of study drug, and had at least 1 post-baseline laboratory value. ANCOVA with LOCF methodology was used.||mg/dL||Standard Deviation|Mean
854857|NCT01736397|Primary|Change in Transferrin Saturation (TSAT) From Baseline to End of Treatment|The difference in TSAT between the value at the end of treatment (week 12) minus the baseline measurement.|12 Weeks|Efficacy analyses were based on Intent-to-Treat (ITT) population, which consisted of all randomized subjects who had a baseline laboratory value, had taken at least 1 dose of study drug, & had at least 1 post-baseline laboratory value. ANCOVA with Last observation carried forward (LOCF) methodology was used.||% saturation||Standard Deviation|Mean
854858|NCT01623739|Secondary|Radiographic Bone Level|Secondary outcome measures will be recorded at 3, 6, 12, 24, 36, 48, 60 months after crown delivery.|Up to 5 years after baseline||||||
854859|NCT01623739|Secondary|Modified Bleeding Index|Secondary outcome measures will be recorded at 3, 6, 12, 24, 36, 48, 60 months after crown delivery.|Up to 5 years after baseline||||||
854860|NCT01623739|Secondary|Modified Plaque Index|Secondary outcome measures will be recorded at 3, 6, 12, 24, 36, 48, 60 months after crown delivery.|Up to 5 years after baseline||||||
854861|NCT01623739|Secondary|Probing Depth|Secondary outcome measures will be recorded at 3, 6, 12, 24, 36, 48, 60 months after crown delivery.|Up to 5 years after baseline||||||
854862|NCT01623739|Secondary|PES/WES (Pink Esthetic Score, White Esthetic Score).|Secondary outcome measures will be recorded at 3, 6, 12, 24, 36, 48, 60 months after crown delivery.|Up to 5 years after baseline||||||
854863|NCT01623739|Primary|Mid Facial Mucosal Level at Implant Site|Baseline will be at the time of crown delivery. Thereafter, the mid facial mucosal level at implant site will be recorded at 3, 6, 12, 24, 36, 48, 60 months after crown delivery.|3 months after crown delivery|||mm||Standard Deviation|Mean
854864|NCT01617460|Primary|Mean Change From Baseline at the Final Assessment in Aberrant Behavior Checklist Japanese Version (ABC-J) Irritability Subscale Score|The ABC-J Irritability subscale consists of 15 items. Each item scores range from 0 to 3: 0 = No problem, 1 = Mild aberrant behavior, 2 = Moderate aberrant behavior, and 3 = Severe aberrant behavior. Individual scores were summed, therefore, the overall score range was between 0-45. Higher scores represent worse condition.|Baseline, the final administration|||units on a scale||Standard Deviation|Mean
854865|NCT01572298|Secondary|Percentage of New Bone Formation (Histologic)||5 months after surgery||||||
854866|NCT01572298|Primary|Gain in Horizontal Ridge Dimension||5 months after surgery|||gain in ridge width (mm)||Standard Deviation|Mean
854904|NCT01114724|Secondary|Subjects With Coverage of Primary Tear||At implant|Based on number of ITT subjects with available data||participants|||Number
854905|NCT01114724|Secondary|Subjects With Successful Delivery and Deployment of the Device.||At implant.|Based on number of ITT subjects with available data||participants|||Number
854972|NCT00625404|Primary|Confirmed Grade 3 or Higher Reduction in Phosphorus|Repeat specimens were collected to confirm chemistry toxicities. Grade 3 phosphorus reduction was defined as ≤2.4mg/dL|Through 52 weeks on product and 4 weeks post-product|||participants|||Number
854867|NCT01536197|Secondary|Changes on Emotional, External and Restricted Eating Behavior and Food Craving After Bariatric Surgery-induced Weight Loss (Roux-en-Y Gastric Bypass and Laparoscopic Adjustable Gastric Banding).|-Eating behavior will be measured with validated questionnaires including among others the Dutch Eating Behavior Questionnaire (DEBQ) and the Food Craving Inventory (FCI). The DEBQ measures three common psychological dimensions of eating behavior: 1) emotional eating , 2) external eating (an inclination to eat in response to external food cues such as the smell and taste of food), and 3) restrained eating (an inclination to consciously restrict food intake to control body weight). The FCI is a validated measure of the frequency of overall food cravings as well as cravings for specific types of foods (high fats, sweets, carbohydrates/ starches, and fast-food fats) during the past month. For the DEBQ and the FCI, subjects score their answers by using a 5-point Likert scale (1=never, 5=very often/always).Therefore, lower numbers means having less frequent food cravings (for FCI), or engaging less frequently in the particular type of eating behavior (for DEBQ).|we will measure the above outcomes before surgery and at 20% weight loss post surgery, which on average we expect will occur around 3 months post-surgery|||units on a scale||Standard Deviation|Mean
854868|NCT01536197|Primary|Changes on Taste Detection Thresholds After Bariatric Surgery-induced Weight Loss (Roux-en-Y Gastric Bypass and Laparoscopic Adjustable Banding).|-Taste detection thresholds measures the lowest concentration of a tastant that can be detected (mili molar amounts).|we will measure the above outcomes before surgery and at 20% weight loss post surgery, which on average we expect will occur around 3 months post-surgery|||mmol/L||Inter-Quartile Range|Median
854869|NCT01514357|Primary|Changes in Systolic Blood Pressure (BP)|The change in BP with treatment over 7 days was assessed by the mean BP on admission, (treatment day 1) mean BP 23 hours after the first injection of BNP, and mean BP 23 hours after the second injection of BNP (treatment day 2). Treatment day 2 was 7 days after admission.|baseline, treatment day 1, treatment day 2|||mmHg||Standard Deviation|Mean
854870|NCT01420926|Secondary|Adverse Events|Adverse Events: Incidence of adverse events, assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Adverse events were collected every cycle during treatment and up to one month after treatment. Adverse events were summarized using summary statistics and frequency tables for each separate cohort. Per protocol, analysis was descriptive in nature. In this section, the number of patients that reported a grade 4 or higher event are summarized. A complete listing of Adverse Events is provided in the Adverse Events section below.|Duration of treatment|The 4 participants were not evaluated for adverse events were excluded from this analysis.||participants|||Number
854871|NCT01420926|Secondary|Progression-free Survival|Progression free survival (PFS) was defined as the time from study entry to progression or death. Progression free and surviving patients were censored at the date of last follow-up. The median DFS with 95% CI was estimated using the Kaplan Meier method.|Time from study entry to progression and/or death (up to 10 years)|||months||95% Confidence Interval|Median
854872|NCT01420926|Secondary|Disease-free Survival (DFS)|Disease free survival (DFS) was defined as the time from CR to relapse or death. Relapse free and surviving patients were censored at the date of last follow-up. The median DFS with 95% CI was estimated using the Kaplan Meier method. Relapse is defined as the reappearance of blood blasts or >= 5% marrow blasts after achieving a CR or CRi.|Time from study entry to relapse and/or death (up to 10 years)|Only participants who achieved a CR are included in this analysis.||months||95% Confidence Interval|Median
854873|NCT01420926|Secondary|Complete Remission Rate (CR and CRi)|Defined as the number of patients who achieve a CR or CRi divided by the total number of evaluable patients. A Complete remission (CR) requires: <5% marrow blast, > 200 nucleated cells, no blasts with auer rods, no extramedullary disease, ANC >1,000/mm^3 and platelets > 100,000/mm^3. A CR with incomplete blood count recovery (CRi) is defined as CR with exception of ANC < 1,000/mm^3 or platelets < 100,000/mm^3.|Duration of study up to 10 years|||percentage of participants||95% Confidence Interval|Number
854874|NCT01420926|Primary|Overall Survival (OS) Time|Overall survival (OS) was defined as the time from study entry to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% CI was estimated using the Kaplan Meier method.|Time from study entry to death assessed up to 10 years|||months||95% Confidence Interval|Median
854875|NCT01336413|Other Pre-specified|Quantitative Susceptibility Mapping/Susceptibility Tensor Imaging (Exploratory Neuroimaging Outcome)|Quantitative Susceptibility Mapping/Susceptibility Tensor Imaging (QSM/STI) to assess possible myelin brain changes related to the intervention.|10 weeks||02/2018||||
854876|NCT01336413|Other Pre-specified|Diffusion Tensor Imaging (Exploratory Neuroimaging Outcome)|Diffusion Tensor Imaging (DTI) to assess possible white matter brain changes associated with intervention.|10 weeks||02/2018||||
854877|NCT01336413|Other Pre-specified|Functional Magnetic Resonance Imaging (Exploratory Neuroimaging Outcome)|Functional Magnetic Resonance Imaging (fMRI) to assess possible functional brain changes related to attention and emotion circuits associated with the intervention.|10 weeks||02/2018||||
854878|NCT01336413|Secondary|Connor-Davidson Resilience Scale (CD-RISC)|The CD-RISC was developed and tested as (i) a measure of degree of resilience, (ii) as a predictor of outcome to treatment with medication or psychotherapy, stress management and resilience-building, (iii) as a marker of progress during treatment, and (iv) as a marker of biological changes in the brain. The scale comprises 25 items, each rated on a 5-point scale (0-4) for a total range of 0-100, with higher scores reflecting greater resilience.|Baseline, 4 Weeks, and 8 Weeks|3 subjects in Arm 1, and 1 subject in Arm 2, withdrew prior to the final visit of the study.||Total Score||Standard Error|Mean
854879|NCT01336413|Secondary|CAPS Total Scores|Mean scores in posttraumatic stress disorder symptoms. Scores may range from 0 (no symptoms) to 136 (severe symptoms; score of 136 is based on the first 17 CAPS items administered). A reduced CAPS score indicates a reduction in (improvement) PTSD symptoms, while and increase in CAPS score indicates an increase (worsening) in PTSD symptoms.|Baseline, 4 Weeks, and 8 Weeks|3 subjects in Arm 1, and 1 subject in Arm 2, withdrew prior to the final visit of the study.||Total Score||Standard Error|Mean
854880|NCT01336413|Secondary|BAC Composite|Composite z scores (allowing comparison from week 2 to week 10) to assess cognitive changes. The BAC includes brief assessments of executive functions, verbal fluency, attention, verbal memory, working memory and motor speed. z scores are calculated from composite scores. Higher z scores are indicative of better cognitive performance, lower z scores are indicative of lower cognitive performance. Range of z scores anticipated to be between -3 and 3.|Baseline, 4 Weeks, and 8 Weeks|3 subjects in Arm 1, and 1 subject in Arm 2, withdrew prior to the final visit of the study.||Composite z Score||Standard Error|Mean
854883|NCT01336413|Primary|CAPS (Cluster D Symptoms) - PRIMARY BEHAVIORAL OUTCOME MEASURE|"The CAPS-IV criterion D is defined by persistent symptoms of increasing arousal (not present before the trauma), indicated by at least two of the following: difficulty falling or staying asleep, irritability or outbursts of anger, difficulty concentrating, hyper-vigilance, and exaggerated startle response There are two scales, frequency and intensity. Frequency scores range from 0 = none of the time to 4 = most or all of the time and intensity scores range from 0 = none to 4 = extreme. Severity scores are calculated from the sum of frequency and intensity scores. Five items are included in criterion D, thus the range of severity scores is 0-45. Higher scores are indicative of more symptoms."|Baseline, 4 Weeks, and 8 Weeks|3 subjects in Arm 1, and 1 subject in Arm 2, withdrew prior to the final visit of the study||Score||Standard Error|Mean
854884|NCT01187381|Secondary|Percentage of Participants by the Site of First Disease Progression||Baseline up to 5 years|Number of participants analyzed=participants who presented disease progression||percentage of participants|||Number
854885|NCT01187381|Secondary|Progression Free Survival|Progression free survival was defined as the time from first dose of trastuzumab to disease progression as assessed by treating physician. Due to observational nature of the study, there was no specific method of assessment used to define progressive disease. Progressive disease was confirmed by treating physician, based on his/her assessment according to local practice.|Baseline uo tp 5 years|Number of participants analyzed=participants who presented progression of disease||days||Full Range|Median
854886|NCT01187381|Secondary|Percentage of Participants Who Received Trastuzumab as Adjuvant Therapy of HER2 Positive Breast Cancer||Baseline up to 5 years|All enrolled participants||percentage of participants|||Number
854887|NCT01187381|Secondary|Percentage of Participants Who Had Surgical Procedure for Breast Cancer|Percentage of participants who underwent different types of surgical procedures for breast cancer are reported. Different types of surgical procedures included: breast-conserving surgery; mastectomy; and other (any other surgical procedure except breast-conserving surgery and mastectomy).|Baseline up to 5 years|Number of participants analyzed=participants who were evaluable for this outcome measure||percentage of participants|||Number
854888|NCT01187381|Secondary|Percentage of Participants Who Received Previous Neoadjuvant Therapy|As a neoadjuvant therapy, participants received chemotherapy alone, radiotherapy alone, hormonal therapy alone or combination of these therapies. Percentage of participants who received these therapies is reported.|Baseline up to 5 years|Number of participants analyzed=participant with data available for this outcome||percentage of participants|||Number
854889|NCT01187381|Secondary|Percentage of Participants Who Discontinued Trastuzumab Therapy According to Reasons for Discontinuation||Baseline up to 5 years|All enrolled participants||percentage of participants|||Number
854890|NCT01187381|Primary|Treatment Duration With Trastuzumab in the Routine Clinical Practice||Baseline up to 5 years|Number of participant analyzed=participants with data available for this outcome measure.||Days||Standard Deviation|Mean
854891|NCT01126801|Secondary|Improvement of Mood, Measured by the Self-rated Beck Depression Inventory (BDI) From Baseline to Study End.||one month|No participants were analyzed since the study was terminated due to difficulty recruiting subjects. Because data from only one subject per arm were collected, these data are not reported to preserve subject privacy.|||||
854892|NCT01126801|Primary|Improvement of Mood, Measured by the Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) From Baseline to Study End.||one month|No participants were analyzed since the study was terminated due to difficulty recruiting subjects. Because data from only one subject per arm were collected, these data are not reported to preserve subject privacy.|||||
854893|NCT01114724|Secondary|Subjects With Device, Procedure and/or Aortic Related Serious Adverse Events.||at 12 months|Based on number of ITT subjects with available data. Subjects were considered unevaluable if they were withdrawn or were lost to follow-up before the lower limit of the 12 mos follow-up window.One subject was lost to follow-up and one withdrew before 12 mos. One of these subjects experienced an AE before study exit and was included in the analysis,||participants|||Number
854894|NCT01114724|Secondary|Subjects With Device, Procedure and/or Aortic Related Serious Adverse Events.||at 30 days|Based on number of ITT subjects with available data.||participants|||Number
854895|NCT01114724|Secondary|Aortic Remodeling: Subjects With Stable (+/- 5mm) or Decrease in False Lumen (>5mm) Compared to First Post-procedural CT Over the Stent Graft||at 12 months|Based on number of ITT subjects with evaluable imaging data.||participants|||Number
854896|NCT01114724|Secondary|Aortic Remodeling: Subjects With Stable (+/- 5mm) or Decrease in False Lumen (>5mm) Compared to First Post-procedural CT Over the Stent Graft||at 6 months|Based on number of ITT subjects with evaluable imaging data.||participants|||Number
854897|NCT01114724|Secondary|Aortic Remodeling: Subjects With Stable (+/- 5mm) or Increase in True Lumen (>5mm) Compared to First Post-procedural CT Over the Stent Graft||at 12 months|Based on number of ITT subjects with evaluable imaging data.||participants|||Number
854898|NCT01114724|Secondary|Aortic Remodeling: Subjects With Stable (+/- 5mm) or Increase in True Lumen (>5mm) Compared to First Post-procedural CT Over the Stent Graft||at 6 months|Based on number of ITT subjects with evaluable imaging data.||participants|||Number
854899|NCT01114724|Secondary|Aortic Remodeling: Subjects With Complete/Partial Thrombosis of the False Lumen Over the Stented Segment||At 12 months|Based on number of ITT subjects with evaluable imaging data.||participants|||Number
854900|NCT01114724|Secondary|Aortic Remodeling: Subjects With Partial/Complete False Lumen Thrombosis Over the Stented Segment||At 6 months|Based on number of ITT subjects with evaluable imaging data.||participants|||Number
854901|NCT01114724|Secondary|Subjects With Secondary Endovascular Procedures||Through12 months|Based on number of ITT subjects with available data. Subjects were considered unevaluable if they were withdrawn before the lower limit of the 12 months follow-up window or were lost to follow-up before the lower limit of the 12 months follow-up window. (One patient withdrew and one was lost to follow-up)||participants|||Number
854902|NCT01114724|Secondary|Aortic Rupture||Within 12 months|Based on number of ITT subjects with available data. Subjects were considered unevaluable if they were withdrawn before the lower limit of the 12 months follow-up window or were lost to follow-up before the lower limit of the 12 months follow-up window. (One patient withdrew and one was lost to follow-up)||participants|||Number
854903|NCT01114724|Secondary|Aortic Rupture||Within 30 days|Based on number of ITT subjects with available data.||participants|||Number
854906|NCT01114724|Secondary|All-cause Mortality||at 12 months|Based on number of ITT subjects with available data. Subjects were considered unevaluable if they were withdrawn before the lower limit of the 12 months follow-up window or were lost to follow-up before the lower limit of the 12 months follow-up window. (One patient withdrew and one was lost to follow-up)||participants|||Number
854907|NCT01114724|Primary|All Cause Mortality.||Up to 30 days after the stent graft implant.|Based on number of ITT subjects with available data||participants|||Number
854908|NCT01094743|Secondary|Subjective Assessment of Lens Comfort|Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.|10 minutes after lens insertion at time of initial lens fitting|||units on a scale||Standard Deviation|Mean
854909|NCT01094743|Primary|Subjective Assessment of Quality of Vision|Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.|after 1 week of lens wear|||units on a scale||Standard Deviation|Mean
854910|NCT01094743|Secondary|Bulbar Redness|Scale of 0 to 4, where 0=None, 2=Trace, 3=Mild, 4=Moderate, 5=Severe.|after 1 week of lens wear|||eyes|eyes||Number
854911|NCT01094743|Secondary|Limbal Redness|Scale of 0 to 4, where 0=None, 2=Trace, 3=Mild, 4=Moderate, 5=Severe.|after 1 week of lens wear|||eyes|eyes||Number
854912|NCT01094743|Primary|Subjective Assessment of Lens Comfort|Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.|after 1 week of lens wear|Completed subjects||units on a scale||Standard Deviation|Mean
854913|NCT01094743|Primary|Visual Acuity Binocular|Snellen binocular visual acuity measurement|after 1 week of lens wear|All completed subjects||participants|||Number
854914|NCT01094743|Primary|Visual Acuity Monocular|Snellen monocular visual acuity measurement|after 1 week of lens wear|All completed subjects||eyes|eyes||Number
854915|NCT01035606|Secondary|Change to Attention and Executive Functioning Composite Scores|"Participants completed the following neuropsychological measures of attention and executive functions before and after Arms 1 and 2, but not Arm 3.
Letter Number Sequencing from WIAT-III; Auditory Consonant Trigram: 9,18, 36 seconds; Digit Vigilance Test (Time and Errors); DKEFS subtests: Design Fluency, Verbal Fluency Switching, Inhibition (Time and Errors); and Inhibition/Switching (Time and Errors); and Trails B. Performance on these measures were scored based upon age, and when available, educational and repeated administration norms. Resultant scores were transformed into z-scores and aggregated to form a composite measure. Higher z-scores reflect better functioning.
The unit of analysis for this outcome was the change score from baseline to post-training. Positive change scores reflect improved performance over time[post-training - baseline], whereas negative change scores reflect worsening performance over time."|5 weeks (After completion of Arm 1 and Arm 2)|||Aggregate Z-scores||Standard Deviation|Mean
854916|NCT01035606|Secondary|Change From Baseline to Post-training for Task Errors on a Functional Performance Measure|Participants completed a functional assessment task, the modified Multiple Errands Task (MET). The MET is an unstructured functional task that permits assessment of participants' abilities to follow outlined rules and complete multiple 'real-world' tasks in a limited time period. Participants were provided written instructions and a map of the hospital where the assessment took place, and were instructed to complete 12 subtasks in 40 minutes while following 9 specified rules. Participants completed this at task at baseline and following Training (Arms 1 & 2, but not 3). Outcome measure was computed as post-training - baseline (negative value reflects less errors made post-training).|5 weeks (After completion of Arm 1 and Arm 2)|||Number of task failures||Standard Deviation|Mean
854917|NCT01035606|Primary|Self-report|Responses to goal processing questionnaire relating to areas of personal goal-based functioning. This scale measured participants self-perceived changes to their cognitive and emotional functioning. Participants indicated the degree to which they perceived changes to 11 questions after receiving trainings in Arm 1 and Arm 3 on a 10-point scale (1=domain became worse, 5 = no change, 10 = domain improved). Participants did not complete this measure after Arm 2.|5 Weeks (After completion of active trainings in Arm 1 and Arm 3)|||units on a scale||Standard Deviation|Mean
854918|NCT01005576|Secondary|Secondary Objectives: Incidence of Transplant-related Outcomes for 2 Years.|Development of graft versus host disease (GVHD)|2 years|||Participants|||Count of Participants
854919|NCT01005576|Primary|Primary Objective: Event-free Survival at 1 Year.||1 year|||Participants|||Count of Participants
854920|NCT00907218|Secondary|Spontaneous Reports of Adverse Effects|Reports of adverse events were completed at baseline and weekly visits throughout the trial.|Weekly for 7 weeks|Data was not collected due to study termination, 2 subjects were recruited however their data was not analyzed|||||
854921|NCT00907218|Secondary|Vital Signs|Vital signs were collected at each study visit, including height, weight, blood pressure, and heart rate.|Weekly for 7 weeks|Data was not collected due to study termination, 2 subjects were recruited however their data was not analyzed|||||
854922|NCT00907218|Secondary|ADHD Clinical Global Impressions Scale Improvement (CGI-I) and Severity (CGI-S)|The Clinical Global Impression Scale of ADHD for Improvement and Severity assess overall severity and change in severity of ADHD. The CGI-I scale is rated from 1 to 7 (1=very much improved; 7=very much worse). The CGI-S is rated from 1 to 7 as well (1=not ill; 7=extremely ill).|Weekly for 7 weeks|Data was not collected due to study termination, 2 subjects were recruited however their data was not analyzed|||||
854923|NCT00907218|Secondary|Rates of Smoking Cessation|Varenicline has efficacy in smoking sensation; therefore smoking cessation was measured at baseline and at all study visits.|Weekly for 7 weeks|Data was not collected due to study termination, 2 subjects were recruited however their data was not analyzed|||||
854925|NCT00907218|Primary|Time Line Follow Back of Cigarette Smoking|The reduction in cigarette smoking, defined as the change from baseline on the amount of cigarettes per day smoked (cpd), using the time-line follow back method. This method involves asking subjects to retrospectively estimate their cigarette use 7 days to 2 years prior to the interview date.|Weekly for 7 weeks|Data was not collected due to study termination, 2 subjects were recruited however their data was not analyzed|||||
854926|NCT00907218|Primary|The DSM-IV Based Adult ADHD Investigator Symptom Rating Scale (AISRS)|The AISRS is an 18-item questionnaire administered by the clinician assessing each of the individual DSM-IV symptoms of ADHD. Each symptom is rated on a scale of severity from 0 (none) to 3 (severe), and the 18 symptom questions are summed to calculate a total score. The minimum total score is a 0, while the maximum total score is a 54.|Weekly for 7 weeks|Data was not collected due to study termination, 2 subjects were recruited however their data was not analyzed|||||
854927|NCT00899847|Secondary|Overall Survival (OS)|To evaluate the graft versus myeloma effect by monitoring rate of overall survival (OS)|2 years after the last participant is enrolled|Includes all study participants||percentage of participants||95% Confidence Interval|Number
854928|NCT00899847|Secondary|Event-free Survival (EFS)|To evaluate the graft versus myeloma effect by monitoring rate of event-free survival (EFS)|2 years after the last participant is enrolled|Includes all study participants||percentage of participants||95% Confidence Interval|Number
854929|NCT00899847|Secondary|Partial Response Rate (PRR)|"Partial response rate (PRR) was assessed as
> 50% reduction in serum M-protein plus urine M-protein reduction by 90% or < 200 mg/24 hr
If serum M-protein is not measurable, then > 50% reduction in the involved serum free light chain
If involved serum free light chain is not measurable, then > 50% reduction in the bone marrow plasma cell percentage + > 50% reduction in the size of any soft tissue plasmacytoma."|1 year|Includes all study participants||Participants|||Count of Participants
854930|NCT00899847|Secondary|Complete Response Rate (CRR)|"Complete response rate (CRR) was assessed as all of:
Negative immunoflixation on the serum and urine
Disappearance of any soft tissue plasmacytomas
< 5% plasma cells in bone marrow"|1 year|Includes all study participants||Participants|||Count of Participants
854931|NCT00899847|Secondary|Overall Response Rate (ORR)|Overall response rate (ORR) = Complete Response Rate (CRR) + Partial Response Rate (PRR)|1 year|Includes all study participants||Participants|||Count of Participants
854932|NCT00899847|Secondary|Median Time to Engraftment After Allo-PBSC Transplant|"Engraftment is assessed as:
Neutrophil engraftment is > 0.5 x 10⁹/L after cytopenia
Platelet engraftment is > 20 x 10⁹/L after cytopenia"|1 month|Due to the less intensive conditioning before allo-PBSC, only 2 participants experienced cytopenia, and thus only 2 participants could be evaluated for engraftment after allo-PBSC.||Days||Full Range|Median
854933|NCT00899847|Secondary|Median Time to Engraftment After Auto-PBSC Transplant|"Engraftment is assessed as:
Neutrophil engraftment is > 0.5 x 10⁹/L after cytopenia
Platelet engraftment is > 20 x 10⁹/L after cytopenia"|1 month|Includes all study participants||Days||Full Range|Median
854934|NCT00899847|Primary|Incidence of Graft Versus Host Disease (GvHD)|To evaluate the incidence acute GvHD of this tandem autologous/allogeneic transplant setting|2 years after the last participant is enrolled.|Due to the significance of the allo-PBSC transplant as a component to the treatment plan, participants who did not receive allo-PBSC are not included.||Participants|||Count of Participants
854935|NCT00888628|Secondary|Number of Participants With Severe Hypoglycemic Events|Subjects will have a decrease in severe hypoglycemic events|1 year after subject's first transplant|||Participants|||Count of Participants
854936|NCT00888628|Secondary|Measures of Metabolic Control||1 year after the subject's first islet transplant||||||
854937|NCT00888628|Secondary|Renal Impact Measures Including Renal Allograft Survival||1 year after the subject's first islet transplant||||||
854938|NCT00888628|Secondary|Impact on Vision||1 year after the subject's first islet transplant||||||
854939|NCT00888628|Secondary|Number of Cardiovascular Events, Cerebral Vascular Accident, and Myocardial Infarction||1 year after the subject's first islet transplant||||||
854940|NCT00888628|Secondary|Change in Urinary Albumin and Creatinine Ratio and Serum Creatinine||1 year after subjects initial islet transplant||||||
854941|NCT00888628|Secondary|Number of Participants With a Decrease in HbA1c|Subjects will have a decrease in HbA1c|1 year after subject's first islet transplant|||Participants|||Count of Participants
854942|NCT00888628|Primary|Insulin Independence With Both an HbA1c ≤ 6.5% and no Severe Hypoglycemic Events at 1 Year After the First Islet Transplant or a Reduction in HbA1c of at Least 1 Point and no Severe Hypoglycemic Events at 1 Year After the First Islet Transplant.||1 year after the subject's first islet transplant|||participants|||Number
854943|NCT00805194|Secondary|Incidence and Intensity of Adverse Events|"Incidence and intensity of adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The worst CTCAE grade per patient is reported and MedDRA version 15.1 used.
Serious signs and symptoms of progressive disease were reported as an adverse event in analysis of this endpoint."|From the first drug administration until 28 days after the last drug administration, up to 42 months|Treated set- all randomised patients who were documented to have taken at least 1 dose of study medication . Patients were allocated to the treatment groups according to the treatment actually received.||% of participants|||Number
854944|NCT00805194|Secondary|Dose Normalised Predose Plasma Concentration at Steady State (Cpre,ss,Norm) of Nintedanib and of Its Metabolites BIBF 1202 and BIBF 1202 Glucuronide|Geometric mean of dose normalised predose plasma concentration (Cpre,ss,norm) of nintedanib and of its metabolites BIBF 1202 and BIBF 1202 glucuronide evaluated at steady state based on course 2 and 3. If only one value was available and valid, then this value was used for calculation of Cpre,ss,norm.|Before the administration of nintedanib or placebo and between a window of 30 mins to an hour after administration of trial drug during Course 2 and between 1 and 3 hours after administration of trial drug during Course 3|Pharmacokinetic set- all patients in the treated set who were documented to have received at least 1 dose of nintedanib and who had at least 1 valid drug plasma concentration available||ng/mL/mg||Geometric Coefficient of Variation|Geometric Mean
854973|NCT00625404|Secondary|Pill Counts and Participant Report of Adherence to Once-daily Pill Taking|Pill counts and participant report of adherence to once-daily pill taking reported as mean days study product could have been used according to pill counts|Up to 52 weeks|All randomized participants who completed at least one follow-up visit, excluding women found to have been infected at enrollment||percentage of days||Standard Deviation|Mean
854945|NCT00805194|Secondary|Quality of Life (QoL)|"QoL was measured by standardised questionnaires (EQ-5D, EORTC QLQ-C30, EORTC QLQ-LC13). The EORTC QLQ-C30 comprises of 30 questions, using both multi-item scales and single-item measures. EORTC LC-13 comprises of 13 questions incorporating 1 multi-item scale and a series of single items.
The following were the main points of interest:
Time to deterioration of cough (QLQ-LC13 question 1), Time to deterioration of dyspnoea (QLQ-LC13, composite of questions 3 to 5), Time to deterioration of pain (QLQ- C30, composite of questions 9 and 19).
Time to deterioration of cough, dyspnoea and pain was defined as the time to a 10-point increase from the baseline score.
Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve"|From randomisation until cut-off date 15 February 2013|Randomised set||months||Inter-Quartile Range|Median
854946|NCT00805194|Secondary|Clinical Improvement|"Clinical improvement was defined as the time from randomisation to deterioration in body weight and/or Eastern Cooperative Oncology group performance score (ECOG PS) whichever occurred first.
Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve."|From randomisation until cut-off date 15 February 2013|Randomised set||months||Inter-Quartile Range|Median
854947|NCT00805194|Secondary|Change From Baseline in Tumour Size|"Percentage change from baseline in tumour size is defined as decrease in the sum of the longest diameter of the target lesion.
Presented means are in fact adjusted best means percentage changes generated from ANOVA model adjusted for baseline ECOG PS (0 vs. 1), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)
This endpoint was analysed based on the central independent reviewer as well as the investigator."|From randomisation until cut-off date 15 February 2013|Randomised Set||percentage of change in tumor size in mm||95% Confidence Interval|Mean
854948|NCT00805194|Secondary|Duration of Disease Control|"The duration of disease control was defined as the time from randomisation to the date of disease progression or death (which ever occurs first) for patients with disease control.
Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.
This endpoint was analysed based on the central independent reviewer as well as the investigator."|From randomisation until cut-off date 15 February 2013|Randomised Set||months||Inter-Quartile Range|Median
854949|NCT00805194|Secondary|Disease Control|"Disease control was defined as a best overall response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) and evaluated according to the modified RECIST criteria version 1.0.
This endpoint was analysed based on the central independent reviewer as well as the investigator."|From randomisation until cut-off date 15 February 2013|Randomised Set||% of participants|||Number
854950|NCT00805194|Secondary|Time to Confirmed Objective Tumour Response|"Time to confirmed objective response is defined as time from randomisation to the date of first documented (CR) or (PR) and evaluated according to the modified RECIST criteria version 1.0.
Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.
This endpoint was analysed based on the central independent reviewer as well as the investigator."|From randomisation until cut-off date 15 February 2013|Randomised Set||months||Inter-Quartile Range|Median
854951|NCT00805194|Secondary|Duration of Confirmed Objective Tumour Response|"The duration of objective response is the time from first documented (CR) or (PR) to the time of progression or death and evaluated according to the modified RECIST criteria version 1.0.
Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.
This endpoint was analysed based on the central independent reviewer as well as the investigator."|From randomisation until cut-off date 15 February 2013|Randomised Set||months||Inter-Quartile Range|Median
854952|NCT00805194|Secondary|Objective Tumour Response|"Confirmed objective response is defined as confirmed Complete Response (CR) and Partial Response (PR) and evaluated according to the modified RECIST criteria version 1.0.
This endpoint was analysed based on the central independent reviewer as well as the investigator."|From randomisation until cut-off date 15 February 2013|Randomised Set||% of participants|||Number
854953|NCT00805194|Secondary|Follow-up Analysis of Progression Free Survival (PFS) as Assessed by Investigator|"Follow-up analysis was conducted at the time of overall survival analysis. Progression Free Survival (PFS) as assessed by investigator according to the modified RECIST (version 1.0) criteria.
Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve."|From randomisation until cut-off date 15 February 2013|Randomised Set||months||Inter-Quartile Range|Median
854954|NCT00805194|Secondary|Follow-up Analysis of Progression Free Survival (PFS) as Assessed by Central Independent Review|"Follow-up analysis was conducted at the time of overall survival analysis. Progression Free Survival (PFS) as assessed by central independent review according to the modified RECIST (version 1.0) criteria.
Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve."|From randomisation until cut-off date 15 February 2013|Randomised Set||months||Inter-Quartile Range|Median
854955|NCT00805194|Secondary|Overall Survival (Key Secondary Endpoint)|"Overall Survival (OS) defined as the duration from randomisation to death (irrespective of the reason of death). Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.
A fixed-sequence-testing was implemented for key secondary endpoint if both the primary and the follow-up analysis showed a treatment benefit (P<0.05) of nintedanib over placebo. In this case, the OS would be tested using hierarchical testing of statistical hypotheses in (1) patients with adenocarcinoma and <9 months since start of first-line therapy, (2) patients with adenocarcinoma, and (3) all patients. Each hypothesis could be only tested at the pre-specified alpha level if the previous null hypothesis in the testing sequence had been."|From randomisation until cut-off date 15 February 2013 (approximately 48 months or 1151 deaths among all patients )|Randomised Set||months||Inter-Quartile Range|Median
854956|NCT00805194|Primary|Progression Free Survival (PFS) as Assessed by Central Independent Review|"Progression Free Survival (PFS) as assessed by central independent review according to the modified RECIST (version 1.0) criteria. Progression free survival (PFS) is defined as the duration of time from date of randomisation to date of progression or death (whatever occurs earlier).
Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve."|From randomisation until cut-off date 2 November 2010 (when 713 PFS events were observed)|Randomised Set||months||Inter-Quartile Range|Median
854957|NCT00790569|Primary|CO-confirmed 7-day Abstinence|Number of participants reporting 7-day abstinence at 12-months, confirmed with CO measurement.|12 Months|||participants|||Number
854958|NCT00790569|Primary|Self-reported 7-day Abstinence|Number of participants with self-reported 7-day abstinence at 12-months|12 Months|||participants|||Number
854959|NCT00790569|Secondary|Reduction in Cigarettes Per Day|Change in mean cigarettes per day|6-Months|||cigarettes/day||Standard Deviation|Mean
854974|NCT00625404|Secondary|Pregnancy Complications|Reported complications during pregnancy, including spontaneous abortion, vaginal or uterine bleeding, emergency c-section and other complications|up to 60 weeks|Women becoming pregnant during regular follow-up in the study (70 in Truvada group and 45 in placebo group)||participants|||Number
854975|NCT00625404|Secondary|FTC and/or Tenofovir Resistance|"Genotypic resistance to FTC and/or tenofovir at the time of HIV diagnosis and 4 weeks later. If resistance was present, testing was repeated at weeks 12, 24, 36 and 52 as necessary (resistance testing will stop if no resistance is detected).
participants were classified as having resistance if they had one or more visits in which resistance was detected, even if the resistance became undetectable over time."|up to 52 weeks|All women who seroconverted were assessed for possible resistance.||participants|||Number
854976|NCT00625404|Secondary|CD4+ T-cell Count|CD4+ T-cell Count at the Time of HIV Seroconversion through 16 weeks|Up to 16 weeks|||cells/mL||Standard Deviation|Mean
854977|NCT00625404|Secondary|Plasma HIV RNA Level (HIV-1 Viral Load)|Viral load at the time of HIV detection, HIV conversion and through 16 weeks|up to 16 weeks|68 women who became infected post-enrollment were included in viral load analyses. Only 48 of these women (27 on Truvada and 21 on placebo) contributed a specimen sample for analysis at the 16-weeks post seroconversion visit||log copies/mL||Standard Deviation|Log Mean
854978|NCT00625404|Primary|Frequency and Nature of Adverse Events (AEs) During and Within 4 Weeks After Study Product Administration||10-26 months per site||||||
854979|NCT00625404|Primary|Confirmed Grade 2 or Higher Serum Creatinine Toxicity|Repeat specimens were collected to confirm chemistry toxicities. Grade 2 or higher serum creatinine toxicity was defined as ≥1.4 times the upper limit of normal|cumulative toxicity through 52 weeks of product use and 4 weeks post product|The Safety Population consisted of all women who were randomized and who had at least one follow-up visit and did not return all of their product un-used. Only women assessed for a particular safety outcome were included in analysis of that outcome.||participants|||Number
854980|NCT00625404|Primary|HIV Infection|HIV Seroconversion, with time to infection refined based on PCR results obtained from stored specimens.|Cumulative HIV infection between enrollment and 52 weeks|All randomized participants who made at least one follow-up visit and were not HIV-positive at enrollment were included in the analysis population||participants|||Number
854981|NCT00601900|Secondary|Treatment Related Toxicity|Graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Tabulated by type, grade, and arm.|Up to 5 years||||||
854982|NCT00601900|Secondary|Time-to-treatment Failure|From randomization until first disease progression, early termination of protocol therapy due to toxicity or withdrawn consent, or going onto non-protocol therapy. Defined by RECIST criteria. The proportional hazards model will be used to compare the arms on time-to-treatment-failure|Up to 5 years||||||
854983|NCT00601900|Secondary|Site of Progression||Up to 5 years||||||
854984|NCT00601900|Secondary|Probability of Surviving Until 36 Months||At 36 months||||||
854985|NCT00601900|Secondary|Duration of Tumor Response|Defined by RECIST criteria.|From the time measurement criteria are met for CR/PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 5 years||||||
854986|NCT00601900|Secondary|Overall Survival (OS)|OS is defined as the time from study entry to death from any cause. The median OS was estimated using the Kaplan-Meier method.|Assessed up to 5 years|Per protocol, the analysis of the primary endpoint was restricted to patients that elected letrozole as endocrine therapy. Of the 348 patients electing Letrozole, 5 did not receive treatment (1 on Arm I, and 4 on Arm II). This left 343 patients (173 on the Arm I and 170 on Arm II) evaluable for the primary endpoint.||months||95% Confidence Interval|Median
854987|NCT00601900|Secondary|Objective Response Rate|Response was defined using RECIST criteria: Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions.|Assessed up to 5 years|Per protocol, the analysis of this endpoint was restricted to patients that elected letrozole as endocrine therapy and began treatment with measureable disease. A total of 213 patients (Arm A:106; Arm B:107) had measureable disease. Of the 213, 197 (Arm A:98, Arm B:99) patients were assessed for response during treatment.||percentage of participants|||Number
854988|NCT00601900|Secondary|6 Month Progression-Free Survival Rate|The 6 month progression-free survival rate was defined as the proportion of patients who were alive progression-free 6 months after registration into the study.|At 6 months|Per protocol, the analysis of the primary endpoint was restricted to patients that elected letrozole as endocrine therapy. Of the 348 patients electing Letrozole, 5 did not receive treatment (1 on Arm I, and 4 on Arm II). This left 343 patients (173 on the Arm I and 170 on Arm II) evaluable for the primary endpoint.||percentage of participants||95% Confidence Interval|Number
854989|NCT00601900|Secondary|12 Month Progression Free Survival Rate|The 12 month progression-free survival rate was defined as the proportion of patients who were alive progression-free 12 months after registration into the study.|At 12 months|Per protocol, the analysis of the primary endpoint was restricted to patients that elected letrozole as endocrine therapy. Of the 348 patients electing Letrozole, 5 did not receive treatment (1 on Arm I, and 4 on Arm II). This left 343 patients (173 on the Arm I and 170 on Arm II) evaluable for the primary endpoint.||percentage of participants||95% Confidence Interval|Number
854990|NCT00601900|Primary|Progression-free Survival|The Primary Endpoint for this study was to compare the progression-free survival of letrozole therapy alone with the combination of letrozole therapy plus bevacizumab as first-line treatment in women with estrogen- and/or progesterone-receptor-positive advanced breast cancer. Progression-free survival (PFS) was defined as the time from randomization until disease progression or death, whichever occurs first. The median PFS was estimated using the Kaplan-Meier method. Progression was assessed per RECIST criteria, and defined as at least a 20% increase in the sum of the longest diameters of target lesions from baseline or the appearance of new lesions.|From randomization until disease progression or death whichever occurs first, assessed up to 5 years|Per protocol, the analysis of the primary endpoint was restricted to patients that elected letrozole as endocrine therapy. Of the 348 patients electing Letrozole, 5 did not receive treatment (1 on Arm I, and 4 on Arm II). This left 343 patients (173 on the Arm I and 170 on Arm II) evaluable for the primary endpoint.||months||95% Confidence Interval|Median
855035|NCT00383760|Secondary|Overall Survival|Estimated using the Kaplan-Meier method.|At 1 year|||participants|||Number
855036|NCT00383760|Secondary|Overall Survival|Estimated using the Kaplan-Meier method.|At 6 months|||percentage of participants||95% Confidence Interval|Number
854991|NCT00573833|Other Pre-specified|Median International Prostate Symptom Total Score|Quality of life will be assessed with the MSKCC prostate quality of life instrument. International prostate symptom score index (IPSS). The IPSS index is a seven item questionnaire designed to assess urinary functioning, specifically urinary frequency, nocturia, weak urinary stream, hesitancy, intermittence, incomplete emptying, and urgency. Questions are rated on a six point Likert scale with higher scores indicating more difficulty in urinary functioning. This measure demonstrated a high internal consistency (Cronbach’s alpha = 0.84) with excellent test-retest reliability (r = 0.92).|week 12 reported|||scores on a scale||Full Range|Median
854992|NCT00573833|Other Pre-specified|Number of Participants Having an International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score Greater Than or Equal to 26 Through 12-Week Endpoint|Self-reported erectile function over the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Data presented are the number of participants who return to normal erectile function (IIEF-EF domain score ≥26)|week 12 reported|||participants|||Number
854993|NCT00573833|Primary|Number of Patients With an Acceptable Level of Treatment Related Urinary and Rectal Toxicity as Defined at < Grade 3 CTC Toxicity|urinary and rectal toxicity-see the adverse event tables|Within 90 days of treatment (early toxicities) or after 90 days (late toxicities)|||participants|||Number
854994|NCT00573833|Primary|Number of Patients With an Acceptable Level of Severe Toxicity as Defined at < Grade 3 CTC Toxicity|Feasibility will be defined as an acceptable level of severe toxicity (both acute and late effects), and adequate dosimetric coverage. Severe toxicity will be defined as > or = grade 3 NCI CTC toxicity|At scheduled 3 month intervals for one year|||participants|||Number
854995|NCT00573872|Primary|Access Local Tumor Control|Lack of tumor growth by CT or MRI at last follow-up|2 years|||Participants|||Count of Participants
854996|NCT00573872|Primary|Assess the Acute and Late Toxicity of Spinal Radiosurgery|CTCAE version 3. Acute toxicity will be recorded if toxicity occurs early phase or within 3 months, and late toxicity would be any toxicity that follows those 3 months.|2 years|||events|||Number
854997|NCT00573872|Primary|Estimate the Palliative Response (Pain or Relief of Neurologic Symptoms) From Single Fraction Radiosurgery Delivered With Tomotherapy|"Physician's subjective report of palliative pain relief. The maximal benefit patient received (best response) is reported. Scale is pain described as worse, stable, better, or completely resolved. In the reporting better or completely resolved indicates response to treatment."|2 years|||Participants|||Count of Participants
854998|NCT00432159|Secondary|Average Radiographic Disc Height (mm) - Change From Post-op||24 months|As Treated. The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).||mm||Standard Deviation|Mean
854999|NCT00432159|Secondary|Global Cervical Range of Motion - Change From Baseline||24 months|As Treated. The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).||degrees||Standard Deviation|Mean
855000|NCT00432159|Secondary|Subject Satisfaction|Subject Satisfaction (Would you have this procedure again?)|24 months|Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).||participants|||Number
855001|NCT00432159|Secondary|Activity|Clinical Assessment of Activity|24 months|Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).||participants|||Number
855002|NCT00432159|Secondary|Return to Work|Estimated Proportion of Subjects Returning to Work|24 months|Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).||% of subjects who returned to work|||Number
855003|NCT00432159|Secondary|Work Status Assessment||24 months|Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).||participants|||Number
855004|NCT00432159|Secondary|SF-36 - Mental Composite Scores (MCS) - Change From Baseline|Change from baseline in Quality of Life - Mental Composite Scores. SF-36 is based on units on a scale; where 0 is severe disability and 100 is no disability. The scores are scaled (based on weighted sum of the questions)|24 months|Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).||Units on a scale||Standard Deviation|Mean
855005|NCT00432159|Secondary|SF-36 - Physical Composite Scores (PCS) - Change From Baseline|Change from baseline in Quality of Life - Physical Composite Scores. SF-36 is based on units on a scale; where 0 is severe disability and 100 is no disability. The scores are scaled (based on weighted sum of the questions)|24 months|Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).||Units on a scale||Standard Deviation|Mean
855037|NCT00383760|Secondary|Median Survival Time|Estimated using the Kaplan-Meier method.|Up to 3 years|||months||95% Confidence Interval|Median
855006|NCT00432159|Secondary|Dysphagia Disability Index - Change From Baseline|Change from baseline in Dysphagia Disability Index (DDI). The DDI is designed to evaluate dysphagia, difficulty in swallowing, using a 25-item questionnaire. Responses from the questionnaire were scored as “always” 4, “sometimes” 2, or “never” 0, and summed to provide a total score (range 0-100). Higher DDI scores suggest greater subjective signs of dysphagia.|24 months|Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).||Units on a scale||Standard Deviation|Mean
855007|NCT00432159|Secondary|Average Shoulder Pain VAS - Change From Baseline|Change from baseline in Average of the left and right shoulder VAS scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their shoulder.|24 months|Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).||Units on a scale||Standard Deviation|Mean
855008|NCT00432159|Secondary|Maximum Shoulder Pain VAS - Change From Baseline|Change from baseline in Maximum value of the left and right shoulder VAS scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their shoulder.|24 months|Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).||Units on a scale||Standard Deviation|Mean
855009|NCT00432159|Secondary|Average Arm Pain VAS - Change From Baseline|Change from baseline in average of the left and right arm VAS scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their arm.|24 months|Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).||Units on a scale||Standard Deviation|Mean
855010|NCT00432159|Secondary|Maximum Arm Pain VAS - Change From Baseline|Change from baseline in maximum value of the left and right arm VAS scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their arm.|24 months|Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).||Units on a scale||Standard Deviation|Mean
855011|NCT00432159|Secondary|Neck Pain VAS Scores - Change From Baseline|Change from baseline of the Neck Pain VAS Scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their neck.|24 months|Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).||Units on a scale||Standard Error|Mean
855012|NCT00432159|Secondary|NDI - Change From Baseline|Change from baseline of the Neck Disability Index. NDI has a minimum score of 0 (no disability) and a maximum score of 50 (complete disability) , which is calculated based on the 6 answers to each of the 10 questions. Each answer within a question is given a numerical value 0 to 5.|24 months|Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).||NDI Score||Standard Deviation|Mean
855013|NCT00432159|Secondary|Device-Related SAE Component of Success|no device related serious adverse events|24 months|Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).||participants who are successes|||Number
855014|NCT00432159|Secondary|Subsequent Secondary Surgery Component of Success|no subsequent secondary surgical intervention at the index level|24 months|Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).||participants who are successes|||Number
855015|NCT00432159|Secondary|Neurological Component of Success|no new clinically significant permanent abnormalities in neurological function|24 months|Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).||participants who are successes|||Number
855038|NCT00383760|Secondary|Stable Disease Rate, Evaluated Using RECIST Criteria|Stable disease is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Up to 3 years|||percentage of participants||95% Confidence Interval|Number
855016|NCT00432159|Secondary|NDI Success|15 point improvement in NDI. NDI has a max score of 50, which is calculated based on the 6 answers to each of the 10 questions. Each answer within a question is given a numerical value 0 to 5.|24 months|Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).||participants who are successes|||Number
855017|NCT00432159|Primary|Overall Success|Subject must show 15 point improvement in the Neck Disability Index from baseline to 24 months post operative as well as have no device related SAE, Secondary Surgical Interventions at the index level or any new permanent neurological deterioration.|24 months|The primary outcome was analyzed with an Intent to Treat (As Randomized) analysis. The difference between the number of treated patients and the number of participants analyzed for each group at the 24 month visit is due to: death of one randomized ACDF patient and patients with no data for NDI and Neurological function (missing data).||participants who are successes|||Number
855018|NCT00414726|Primary|Primary Efficacy Outcome Measure is a Comparison of the Change in National Institutes of Health Stroke Scale (NIHSS) Scores From Baseline to 4 Hours (During Therapy) in the Two Groups.|The NIHSS score ranges from 0 (best score) to 42 (worst score).|4 hours after starting treatment|||0-4 hour change in NIHSS score||95% Confidence Interval|Mean
855019|NCT00414726|Primary|Primary Safety Outcome Measure is a Comparison of the Change in National Institutes of Health Stroke Scale (NIHSS) Scores From Baseline to 24 Hours (After Therapy) in the Two Groups.|The NIHSS score ranges from 0 (best score) to 42 (worst score).|24 hours|||0-24 hour change in NIHSS score||95% Confidence Interval|Mean
855020|NCT00409565|Secondary|Disease Control Rate (DCR) ((Clinical Benefit Rate (CBR))|"Disease Control Rate (DCR) (or Clinical Benefit Rate (CBR)), is defined as the percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response and stable disease to cetuximab and bevacizumab.
DCR = number of patients with (at least) partial response or stable disease / total number of evaluable patients"|At 12 weeks|Patients that were evaluable for 'best response' to treatment.||percentage of participants|||Number
855021|NCT00409565|Secondary|Change in Serum Cytokine Concentrations|Ratio of serum cytokines concentration after treatment with cetuximab and bevacizumab to baseline serum cytokines concentration, in picogram/milliliter (pg/ml) for 13 different cytokines. [post-treatment (pg/ml) / baseline (pg/ml)]|Up to 5 years|Patients treated with cetuximab and bevacizumab who provided baseline and post-treatment serum samples.||post-treatment/baseline pg/ml ratio|||Number
855022|NCT00409565|Secondary|Overall Survival (OS)|The length of time from the start of study/treatment that diagnosed patients are still alive.|Up to 5 years|||months||95% Confidence Interval|Median
855023|NCT00409565|Secondary|Progression-free Survival (PFS)|PFS is the length of time during and after treatment that patients are alive with the disease but it does not get worse. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI), Progressive Disease is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Up to 5 years|All patients included in study are assessed for response to treatment, per protocol. Of 46 eligible patients, 45 were evaluable for response.||Months||95% Confidence Interval|Median
855024|NCT00409565|Primary|Objective Response Rate (ORR)|ORR is the percentage of patients whose cancer shrunk or disappeared after study treatment. ORR was determined per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI) : Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR; Progressive Disease (PD): at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Up to 5 years|Assess all patients included in this study for response to treatment, per protocol. Of 46 eligible patients, 45 were evaluable for response.||percentage of participants||95% Confidence Interval|Number
855025|NCT00401817|Secondary|Overall Survival|"The percentage of patients who have survived at the three year time point.
The 3-year OS rate was estimated based on the Kaplan-Meier analysis."|3 years|Evaluable Patients||percentage of patients||95% Confidence Interval|Number
855026|NCT00401817|Secondary|Progression-Free Survival|"The percentage of patients who have not progressed at the three year time point.
The 3-year PFS rate was estimated based on the Kaplan-Meier analysis."|3 years|Evaluable patients||percentage of patients||95% Confidence Interval|Number
855027|NCT00401817|Secondary|Overall Response Rate|"Overall Response Rate measured using Kaplan-Meier survival analysis
Response criteria were those reported by Cheson et al. (1999)"|38 Months (min 33 months, max 62 months)|Evaluable patients||percentage of participants||95% Confidence Interval|Number
855028|NCT00401817|Primary|Number of Participants With Toxicity|Number of patients with reversible myelosuppression (Primary toxicity was reversible myelosuppression) Toxicities were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0.|38 months|||participants|||Number
855029|NCT00383760|Secondary|Objective Stable Disease Rate|Objective stable disease rate Using RECIST|Upto 3 years|Data was not collected|||||
855030|NCT00383760|Secondary|Toxicity|Types of Gr 3 or greater adverse events that are atleast possibly related to study drug|All patients will be evaluable for toxicity from the time of their first treatment with E7389.|||Types of adverse event|||Number
855031|NCT00383760|Secondary|Response Duration||From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 3 years|Data were not collected|||||
855032|NCT00383760|Secondary|Time to Progression|Estimated using the Kaplan-Meier method.|At 1 year|Time to progression at 1 year not analyzed|||||
855033|NCT00383760|Secondary|Time to Progression|"Estimated using the Kaplan-Meier method.
Median time to progression"|At 6 months|||months||95% Confidence Interval|Median
855034|NCT00383760|Secondary|Median Time to Disease Progression|Estimated using the Kaplan-Meier method.|Duration of time from start of treatment until the criteria for progression are met, assessed up to 3 years|||months||95% Confidence Interval|Median
855039|NCT00383760|Primary|Objective Response (Complete and Partial) Evaluated Using RECIST Criteria|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.|Up to 3 years|||participants|||Number
855040|NCT00272844|Secondary|Number of Participants With Improved Neuropsychological Development|Improved neuropsychological development is defined as progressively achieving developmental milestones|Every 3-6 months for an approximate median of 5 years|||Participants|||Count of Participants
855041|NCT00272844|Secondary|Number of Growth Responders|Growth response was defined as an increase in general health, growth, and behavior.|Every 3-6 months for an approximate median of 5 years|||Participants|||Count of Participants
855042|NCT00272844|Primary|Number of Responders|Responders was defined as an increase in total serum cholesterol and a decrease in 7-DHC (7-Dehydrocholesterol), and 8-DHC (8-Dehydrocholesterol) were measured on all participants.|Every 3-6 months for an approximate median of 5 years|||Participants|||Count of Participants
855043|NCT00142506|Primary|Assessment of Erectile Dysfunction|The International Index of Erectile Function (IIEF) is used for the evaluation of male sexual function and diagnostic evaluation of Erectile Dysfunction (ED) severity. There are 5 domains of the IIEF: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. A score of 0-5 is awarded to each question of the IIEF. Total IIEF scores range from 0-75. Lower scores indicate severe erectile dysfunction (0=severe erectile dysfunction), while higher scores indicate less erectile dysfunction (75=no erectile dysfunction).|Baseline, 6 months, 12 months, 24 months|||units on a scale||Inter-Quartile Range|Median
855044|NCT00006184|Primary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|9 years|||Participants|||Count of Participants
855045|NCT00006184|Primary|Immune Response|Immune cell depletion is defined as immunosuppression of participants T cells prior to transplant measured by cluster of differentiation 4 (CD4) counts (i.e. cells) > 50 cells per ul.Immune T-cell depletion helps to reduce the ability to reject allogeneic cells in participants and is required for engraftment. Engraftment is the body's ability to accept donor cells.|105 days|This outcome measure was only pre-specified to be measured in the recipient Arm/Group.||Particpants|||Number
855727|NCT02637804|Primary|Comfort|Subjective ratings of comfort (right after insertion, right before removal, all day long) for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. (Scale 0-10, 0=very poor comfort, 10=very good comfort).|1 week|||units on a scale||Standard Deviation|Mean
855697|NCT02696317|Secondary|Pre-Lens Tear Film MPA After 10 ± 3 Days of Wear and After 3 Hours Exposure to Reduced Humidity (Post RH)|MPA is the minimum area of the contact lens surface (expressed in %) that is protected by the tear film during the entire interblink period. Pre-lens tear film MPA was assessed following 6 hours of wear including 3 hours in a reduced humidity environment (20% RH).. Higher values indicate less dry and more eye comfort.|Day 10 ± 3 days, each product|Full Analysis Set. Number Analyzed is the number of eyes with non-missing response.||percentage of contact lens surface area|Eyes|Standard Deviation|Mean
855698|NCT02696317|Secondary|Pre-Lens Tear Film Minimum Protected Area (MPA) in a Normal Environment After 10 ± 3 Days of Wear (Pre RH)|MPA is the minimum area of the contact lens surface (expressed in %) that is protected by the tear film during the entire interblink period. Pre-lens tear film MPA was assessed in a normal environment following 3 hours of wear. Higher values indicate less dry and more eye comfort.|Day 10 ± 3 days, each product|Full Analysis Set. Number Analyzed is the number of eyes with non-missing response.||percentage of contact lens surface area|Eyes|Standard Deviation|Mean
855699|NCT02696317|Secondary|Tear Film Evaporation Rate After 10 ± 3 Days of Wear and After 3 Hours Exposure to Reduced Humidity (Post RH)|Tear film evaporation rate (amount of tears that evaporates over a surface area per seconds) assessment was performed using the Oregon Health Sciences University Evaporometer. Measurements were taken on both the right and left eyes after 6 hours of lens wear, including 3 hours of wear in a 20% reduced humidity environment (20% RH), after 10 ± 3 days of lens wear. The temperature and humidity were measured within an air chamber around the ocular surface with the eyes opened and closed. The evaporation from the ocular surface was calculated as the difference between the evaporation rate of the skin taken during the closed eye measurement and the evaporation rate taken during the open eye measurement. The rate of evaporation was measured in g/cm2/sec for 2 humidity ranges. A higher evaporation rate can be a contributing factor to eye irritation and lens intolerance.|Day 10 ± 3 days, each product|Full Analysis Set. Number Analyzed is the number of eyes with non-missing response.||10^-7g/cm^2/s|Eyes|Standard Deviation|Mean
855700|NCT02696317|Primary|Tear Film Evaporation Rate in a Normal Environment After 10 ± 3 Days of Wear (Pre RH)|Tear film evaporation rate (amount of tears that evaporates over a surface area per seconds) assessment was performed using the Oregon Health Sciences University Evaporometer. Measurements were taken on both the right and left eyes after 3 hours of wear in a normal environment after 10 ± 3 days of lens wear. The temperature and humidity were measured within an air chamber around the ocular surface with the eyes opened and closed. The evaporation from the ocular surface was calculated as the difference between the evaporation rate of the skin taken during the closed eye measurement and the evaporation rate taken during the open eye measurement. The rate of evaporation was measured in g/cm2/sec for 2 humidity ranges. A higher evaporation rate can be a contributing factor to eye irritation and lens intolerance.|Day 10 ± 3 days, each product|Full Analysis Set. Number Analyzed is the number of eyes with non-missing response.||10^-7g/cm^2/s|Eyes|Standard Deviation|Mean
855703|NCT02640482|Secondary|Percentage of Participants With SVR12 in Arm A DB Active Drug With Prior SOF + RBV ± pegIFN Failure|SVR12 was defined as HCV RNA level <LLOQ 12 weeks after the last dose of active study drug.|12 weeks after the last actual dose of active study drug|All randomized participants who received at least one dose of study drug in Arm A DB with prior SOF + RBV ± pegIFN failures.||percentage of participants|||Number
855704|NCT02640482|Secondary|Percentage of Participants With Post-treatment Relapse in Arm A DB Active Drug Excluding Prior SOF + Ribavirin (RBV) ± pegIFN Failures|Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of DB treatment and 12 weeks after the last dose of active study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment, excluding reinfection.|Between End of Treatment (Week 12) and 12 weeks after the last dose of Arm A DB active drug (up to Week 24)|All randomized participants who received at least 1 dose of study drug in Arm A DB with HCV RNA < LLOQ at the final treatment visit who completed the DB treatment, excluding participants with prior SOF + RBV ± pegIFN failures.||percentage of participants||95% Confidence Interval|Number
855705|NCT02640482|Secondary|Percentage of Participants With On-treatment Virologic Failure in Arm A DB Active Drug Excluding Prior SOF + Ribavirin (RBV) ± pegIFN Failures|On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value of post-baseline HCV RNA during treatment; confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.|Up to Week 12 post baseline|All randomized participants who received at least one dose of study drug in Arm A DB excluding participants with prior SOF + RBV ± pegIFN failures.||percentage of participants||95% Confidence Interval|Number
855726|NCT02637804|Primary|Vision|Subjective ratings of vision (right after insertion, right before removal, all day long) for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. (Scale 0-10, 0=very poor vision, 10=very good vision).|1 week|||units on a scale||Standard Deviation|Mean
855706|NCT02640482|Secondary|Percentage of Participants With SVR12 in Arm A DB Active Drug Excluding Prior SOF + Ribavirin (RBV) ± pegIFN Failures: Superiority Analysis|SVR12 was defined as plasma HCV RNA level <LLOQ 12 weeks after the last dose of study drug. The secondary efficacy endpoint was the superiority of the percentage of participants who achieved SVR12 in Arm A Double Blind (DB) Active Drug excluding prior SOF + RBV ± pegIFN failures compared with the historical control rate for patients treated with the current standard of care (SOF + RBV for 12 weeks). As pre-specified in the study protocol, the primary outcome measure and the secondary outcome measure are not tested independently from each other. Rather, the two measures are ranked in a fixed sequential testing procedure that only if success was demonstrated for the primary outcome (i.e. non-inferiority test of Arm A SVR12 rate to the standard of care) did we test the first secondary outcome (i.e. superiority test of Arm A SVR12 rate to the standard of care).|12 weeks after the last actual dose of active study drug|All randomized participants who received at least one dose of study drug in Arm A DB excluding participants with prior SOF + RBV ± pegIFN failures.||percentage of participants|||Number
855707|NCT02640482|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Arm A DB Active Drug Excluding Prior SOF + Ribavirin (RBV) ± pegIFN Failures: Noninferiority Analysis|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of active study drug. The primary efficacy endpoint was the noninferiority of the percentage of participants who achieved SVR12 in Arm A Double Blind (DB) Active Drug excluding prior sofosbuvir (SOF) + ribavirin (RBV) ± pegylatedinterferon (pegIFN) failures compared with the historical control rate for patients treated with the current standard of care (SOF + RBV for 12 weeks).|12 weeks after the last actual dose of active study drug|All randomized participants who received at least one dose of study drug in Arm A DB excluding participants with prior SOF + RBV ± pegIFN failures.||percentage of participants|||Number
855708|NCT02637804|Secondary|Papillary Conjunctivitis|Papillary conjunctivitis for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe)|1 week|||Eyes|Eyes||Number
855709|NCT02637804|Secondary|Corneal Oedema|Corneal oedema for for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe)|1 week|||Eyes|Eyes||Number
855710|NCT02637804|Secondary|Conjunctival Staining|Conjunctival staining for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe)|1 week|||Eyes|Eyes||Number
855711|NCT02637804|Secondary|Corneal Neovascularization|Corneal neovascularization for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe)|1 week|||Eyes|Eyes||Number
855712|NCT02637804|Secondary|Corneal Staining|Corneal staining for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe)|1 week|||Eyes|Eyes||Number
855713|NCT02637804|Secondary|Limbal Redness|Limbal redness for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe)|1 week|||Eyes|Eyes||Number
855714|NCT02637804|Secondary|Conjunctival Redness|Conjunctival redness for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe)|1 week|||Eyes|Eyes||Number
855715|NCT02637804|Secondary|Lens Fit Overall|Lens fit evaluation overall for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Optimum, Good, Acceptable, Not acceptable (cannot wear))|1 week|||Eyes|Eyes||Number
855716|NCT02637804|Secondary|Lens Fit Overall|Lens fit evaluation overall for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at baseline. (Optimum, Good, Acceptable, Not acceptable (cannot wear))|Baseline|||Eyes|Eyes||Number
855717|NCT02637804|Secondary|Lens Fit - Post-blink Movement|Lens fit evaluation of post-blink movement for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Tight, Little tight, Optimal, Little loose, Loose)|1 week|||Eyes|Eyes||Number
855718|NCT02637804|Secondary|Lens Fit - Post-blink Movement|Lens fit evaluation of post-blink movement for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at baseline. (Tight, Little tight, Optimal, Little loose, Loose)|Baseline|||Eyes|Eyes||Number
855719|NCT02637804|Secondary|Lens Fit - Vertical Centration|Lens fit evaluation of vertical centration for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Upper, Little upper, Centered, Little lower, Lower)|1 week|||Eyes|Eyes||Number
855720|NCT02637804|Secondary|Lens Fit - Vertical Centration|Lens fit evaluation of vertical centration for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at baseline. (Upper, Little upper, Centered, Little lower, Lower)|Baseline|||Eyes|Eyes||Number
855721|NCT02637804|Secondary|Lens Fit - Horizontal Centration|Lens fit evaluation of horizontal centration for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. (Temporal, Little temporal, Centered, Little nasal, Nasal)|1 week|||Eyes|Eyes||Number
855722|NCT02637804|Secondary|Lens Fit - Horizontal Centration|Lens fit evaluation of horizontal centration for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at baseline. (Temporal, Little temporal, Centered, Little nasal, Nasal)|Baseline|||Eyes|Eyes||Number
855723|NCT02637804|Primary|Lens Preference - Stenfilcon A/Delefilcon A (Group 2)|Subjective ratings of lens preference for stenfilcon A/narafilcon A assessed at 1 week. (5 possible ratings: Prefer stenfilcon A, Little Prefer stenfilcon A, No preference, little prefer delefilcon A, prefer delefilcon A).|1 week|||Participants|||Count of Participants
855724|NCT02637804|Primary|Lens Preference - Stenfilcon A/Narafilcon A (Group 1)|Subjective ratings of lens preference for stenfilcon A/narafilcon A assessed at 1 week. (5 possible ratings: Prefer stenfilcon A, Little Prefer stenfilcon A, No preference, little prefer narafilcon A, prefer narafilcon A).|1 week|||Participants|||Count of Participants
855725|NCT02637804|Primary|Handling|Subjective ratings of handling (lens insertion and lens removal) for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. (Scale 0-10, 0=very poor handling, 10=very good handling.|1 week|||units on a scale||Standard Deviation|Mean
855728|NCT02637804|Primary|Dryness|Subjective ratings of dryness (right after insertion, right before removal, all day long) for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. (Scale 0-10, 0=very dry, 10=no dryness at all.|1 week|||units on a scale||Standard Deviation|Mean
855729|NCT02637804|Primary|Red Eye Sensation|Subjective ratings of red eye sensation for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. Grade 0-3, 0=No sensation, 1=Slightly: sometimes felt sensation without any trouble in wearing contact lenses, 2=Mild: always felt sensation without any trouble in wearing contact lenses, 3=Heavy: could not wear contact lense due to sensation|1 week|||Eyes|Eyes||Number
855730|NCT02637804|Primary|Itching Sensation on Removal|Subjective ratings of itching sensation on insertion for each lens pair assessed at 1 week. Grade 0-3, 0=No sensation, 1=Slightly: sometimes felt sensation without any trouble in wearing contact lenses, 2=Mild: always felt sensation without any trouble in wearing contact lenses, 3=Heavy: could not wear contact lense due to sensation|1 week|||Eyes|Eyes||Number
855731|NCT02637804|Primary|Pain and Foreign Body Sensation|Subjective ratings of pain and foreign body sensation for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. Grade 0-3, 0=No sensation, 1=Slightly: sometimes felt sensation without any trouble in wearing contact lenses, 2=Mild: always felt sensation without any trouble in wearing contact lenses, 3=Heavy: could not wear contact lense due to sensation|1 week|||eyes|Eyes||Number
855732|NCT02610634|Other Pre-specified|Geriatric Depression Scale (GDS-15)|This involves 15 questions about the mood of the subjects. Scores of 0 to 4 to be in the normal range, 5 to 9 to indicate mild depression, and 10 to 15 to indicate moderate to severe depression.|Session 1 (full session lasts approx. 3 hours)||||||
855733|NCT02610634|Other Pre-specified|Addenbrookes Cognitive Examination (ACE-R)|The ACE-R involves testing of attention, orientation, memory, fluency, language and visuospatial abilities.|Session 1 (full session lasts approx. 3 hours)||||||
855734|NCT02610634|Other Pre-specified|Montreal Cognitive Assessment (MoCA)|Different cognitive domains are assessed (attention and concentration, executive functions, memory, language, visuo-constructional skills, conceptual thinking, calculations, and orientation).|Session 1 (full session lasts approx. 3 hours)||||||
855735|NCT02610634|Other Pre-specified|Falls Efficacy Scale – International (FES-I)|Fear of falling will be measured using the falls efficacy scale – international version. This is a short and valid measure of fear of falling in older adults, which assesses basic and demanding activities (both physical and social). It consists of 16 scenarios (e.g. cleaning the house) and subjects must rate their fear of falling on a scale from 1 (Not at all concerned) to 4 (Very concerned).|Session 1 (full session lasts approx. 3 hours)||||||
855736|NCT02610634|Other Pre-specified|Freezing of Gait (FOG) Questionnaire|This is a 10 item questionnaire intended to classify freezing of gait. The questionnaire has 3 parts; distinction of freezers from non-freezers, Freezing severity, frequency and duration and impact of freezing on daily life.|Session 1 (full session lasts approx. 3 hours)||||||
855737|NCT02610634|Other Pre-specified|Hoehn & Yahr (H & Y) Scale|The Hoehn and Yahr rating scale is a widely used clinical rating scale, which defines broad categories of motor function in Parkinson’s disease (PD). All participants’ will be tested who are in H &Y stages I-III.|Session 1 (full session lasts approx. 3 hours)||||||
855738|NCT02610634|Other Pre-specified|The Unified Parkinson's Disease Rating Scale (UPDRS)|The Unified Parkinson's Disease Rating Scale will be used to assess motor and non-motor features of PD and disease severity. The UPDRS is scored from a total of 195 points; higher scores reflect worsening disability.|Session 1 (full session lasts approx. 3 hours)||||||
855739|NCT02610634|Other Pre-specified|Contrast Sensitivity|CS will be measured using the Mars CS sheets placed on an adjustable holder. The sheet consists of 48 Latin letters of uniform height; the contrast from the white background decreases with subsequent letters. Room illumination is adjusted so that average CS sheet luminance is between 80 and 120cd/m² (measured via a luminance meter). Assessment is done binocularly with the average distance from the patients eyes being 50cm. Participants read aloud down the sheet starting at the top left. Errors are recorded on the pre-set score sheet and testing is terminated after 2 consecutive errors.|Session 1 (full session lasts approx. 3 hours)||||||
855740|NCT02610634|Other Pre-specified|Visual Acuity|VA is measured binocularly used a standard LogMAR chart. Participants will be seated at a distance of 4m from the chart. Participants will be instructed to read aloud down the chart starting from the top left.|Session 1 (full session lasts approx. 3 hours)||||||
855741|NCT02610634|Other Pre-specified|Visual Object and Space Perception Battery (VOSP)|This study will use a selection of these tests; incomplete letters, dot counting and position discrimination.|Session 1 (full session lasts approx. 3 hours)||||||
855742|NCT02610634|Other Pre-specified|Clock Copying (CLOX 1 and 2)|Participants are required to draw a clock with the numbers and arrows pointed at a particular time. Then the subjects have to copy a clock drawn by the researcher.|Session 1 (full session lasts approx. 3 hours)||||||
855743|NCT02610634|Other Pre-specified|Benton’s Judgement of Line Orientation (JLO) Test|JLO is a test of visuospatial ability, which involves a subject viewing a set of numbered lines and then being shown two lines of the same orientation. Participants then have to name the numbers that the shown lines correspond to.|Session 1 (full session lasts approx. 3 hours)||||||
855744|NCT02610634|Other Pre-specified|CDR Attention Battery (Cognitive Drug Research – CDR, United Biosource Corporation, UK)|The Attention CDR involves a series of computerised tests, which the subjects respond to by pressing one of two buttons. Scores for sub-sections of Simple reaction time, Digit vigilance and Choice reaction time will be obtained.|Session 1 (full session lasts approx. 3 hours)||||||
855745|NCT02610634|Secondary|Visual Sampling Parameter: Number of Blinks During Gait|Number of blinks observed when walking, measured via EOG and Dikablis mobile eye-tracker. Walking conditions include; single task, dual task, through a doorway, whilst turning and with a visual cue in place.|Session 1: observation during gait assessments (lasting approx. 90mins) and one week later in Session 2 for a sub-group (PD and controls n = upto 25) (lasting approx. 60mins)||||||
855746|NCT02610634|Secondary|Visual Sampling Parameter: Saccade Duration During Gait|Duration (ms) of fast eye movements observed when walking, measured via EOG and Dikablis mobile eye-tracker. Walking conditions include; single task, dual task, through a doorway, whilst turning and with a visual cue in place.|Session 1: observation during gait assessments (lasting approx. 90mins)||||||
855747|NCT02610634|Secondary|Visual Sampling Parameter: Fixation Duration During Gait|Duration (ms) of pauses (fixations) between fast eye movements observed when walking, measured via EOG and Dikablis mobile eye-tracker. Walking conditions include; single task, dual task, through a doorway, whilst turning and with a visual cue in place.|Session 1: observation during gait assessments (lasting approx. 90mins)||||||
855748|NCT02610634|Secondary|Visual Sampling Parameter: Fixation Number During Gait|Number of pauses (fixations) between fast eye movements observed when walking, measured via EOG and Dikablis mobile eye-tracker. Walking conditions include; single task, dual task, through a doorway, whilst turning and with a visual cue in place.|Session 1: observation during gait assessments (lasting approx. 90mins)||||||
855749|NCT02610634|Secondary|Visual Sampling Parameter: Saccade Acceleration During Gait|Acceleration (degrees per second squared) of fast eye movements observed when walking, measured via EOG and Dikablis mobile eye-tracker. Walking conditions include; single task, dual task, through a doorway, whilst turning and with a visual cue in place.|Session 1: observation during gait assessments (lasting approx. 90mins)||||||
855750|NCT02610634|Secondary|Visual Sampling Parameter: Saccade Amplitude During Gait|Distance (degrees) of fast eye movements observed when walking, measured via EOG and Dikablis mobile eye-tracker. Walking conditions include; single task, dual task, through a doorway, whilst turning and with a visual cue in place.|Session 1: observation during gait assessments (lasting approx. 90mins)||||||
855751|NCT02610634|Secondary|Visual Sampling Parameter: Saccade Velocity During Gait|Velocity (degrees per second) of fast eye movements observed when walking, measured via EOG and Dikablis mobile eye-tracker. Walking conditions include; single task, dual task, through a doorway, whilst turning and with a visual cue in place.|Session 1: observation during gait assessments (lasting approx. 90mins)||||||
855752|NCT02610634|Secondary|Visual Sampling Parameter: Saccade Number During Gait|Number of fast eye movements observed when walking, measured via EOG and Dikablis mobile eye-tracker. Walking conditions include; single task, dual task, through a doorway, whilst turning and with a visual cue in place.|Session 1: observation during gait assessments (lasting approx. 90mins) and one week later in Session 2 for a sub-group (PD and controls n = upto 25) (lasting approx. 60mins)||||||
855753|NCT02610634|Secondary|Gait Parameter: Double Support Time|Measured in seconds recorded via Vicon 3D motion capture. Observed during the following walking conditions; single task, dual task, through a doorway, whilst turning and with a visual cue in place.|Session 1: observation during gait assessments (lasting approx. 90mins)||||||
855754|NCT02610634|Secondary|Gait Parameter: Single Support Time|Measured in seconds recorded via Vicon 3D motion capture. Observed during the following walking conditions; single task, dual task, through a doorway, whilst turning and with a visual cue in place.|Session 1: observation during gait assessments (lasting approx. 90mins)||||||
855755|NCT02610634|Secondary|Gait Parameter: Step Time|Measured in seconds recorded via Vicon 3D motion capture. Observed during the following walking conditions; single task, dual task, through a doorway, whilst turning and with a visual cue in place.|Session 1: observation during gait assessments (lasting approx. 90mins) and one week later in Session 2 for a sub-group (PD and controls n = upto 25) (lasting approx. 60mins)||||||
855756|NCT02610634|Secondary|Gait Parameter: Step Length|Measured in meters recorded via Vicon 3D motion capture. Observed during the following walking conditions; single task, dual task, through a doorway, whilst turning and with a visual cue in place.|Session 1: observation during gait assessments (lasting approx. 90mins)||||||
855757|NCT02610634|Secondary|Gait Parameter: Gait Speed|Measured in meters per second observed when walking recorded via Vicon 3D motion capture. Walking conditions include; single task, dual task, through a doorway, whilst turning and with a visual cue in place.|Session 1: observation during gait assessments (lasting approx. 90mins)||||||
855758|NCT02610634|Primary|Visual Sampling Parameter: Saccade Frequency During Gait|Number of fast eye movements made per second observed when walking, measured via EOG and Dikablis mobile eye-tracker. Walking conditions include; single task, dual task, through a doorway, whilst turning and with a visual cue in place.|Session 1: observation during gait assessments (lasting approx. 90mins)|||Saccade frequency (sacc/sec)||Standard Deviation|Mean
855777|NCT02540356|Secondary|Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Questionnaire|QoL will be assessed using EORTC QLQ-C30.|Weekly from the baseline visit to the last week of safety follow-up (8 weeks or longer, if additional treatment will be implemented)|Study was terminated early with only one participant dosed. No statistical analysis was performed on this outcome measure. Additionally, due to concerns that the participant would be at risk of being re-identified, study results are not posted.|||||
855778|NCT02540356|Secondary|Imalumab (BAX69) Plasma Pharmacokinetic (PK) Parameter: Volume of Distribution (V)||Predose; and post-dose at 1.5, 4, 8, 24, and 72 hours|Study was terminated early with only one participant dosed. No statistical analysis was performed on this outcome measure. Additionally, due to concerns that the participant would be at risk of being re-identified, study results are not posted.|||||
855779|NCT02540356|Secondary|Imalumab (BAX69) Plasma Pharmacokinetic (PK) Parameter: Apparent Systemic Clearance (CL)||Predose; and post-dose at 1.5, 4, 8, 24, and 72 hours|Study was terminated early with only one participant dosed. No statistical analysis was performed on this outcome measure. Additionally, due to concerns that the participant would be at risk of being re-identified, study results are not posted.|||||
855780|NCT02540356|Secondary|Imalumab (BAX69) Plasma Pharmacokinetic (PK) Parameter: Half-life (t1/2)||Predose; and post-dose at 1.5, 4, 8, 24, and 72 hours|Study was terminated early with only one participant dosed. No statistical analysis was performed on this outcome measure. Additionally, due to concerns that the participant would be at risk of being re-identified, study results are not posted.|||||
855781|NCT02540356|Secondary|Imalumab (BAX69) Plasma Pharmacokinetic (PK) Parameter: Area Under the Concentration vs Time Curve (AUC)||Predose; and post-dose at 1.5, 4, 8, 24, and 72 hours|Study was terminated early with only one participant dosed. No statistical analysis was performed on this outcome measure. Additionally, due to concerns that the participant would be at risk of being re-identified, study results are not posted.|||||
855782|NCT02540356|Secondary|Imalumab (BAX69) Plasma Pharmacokinetic (PK) Parameter: Minimum Observed Concentration (Cmin)||Predose; and post-dose at 1.5, 4, 8, 24, and 72 hours|Study was terminated early with only one participant dosed. No statistical analysis was performed on this outcome measure. Additionally, due to concerns that the participant would be at risk of being re-identified, study results are not posted.|||||
855783|NCT02540356|Secondary|Imalumab (BAX69) Plasma Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax)||Predose; and post-dose at 1.5, 4, 8, 24, and 72 hours|Study was terminated early with only one participant dosed. No statistical analysis was performed on this outcome measure. Additionally, due to concerns that the participant would be at risk of being re-identified, study results are not posted.|||||
855784|NCT02540356|Secondary|Occurrence of Binding and/or Neutralizing Anti-imalumab (BAX69) Antibodies Following Treatment With Imalumab (BAX69)||Throughout the study period of approximately 22 months|Study was terminated early with only one participant dosed. No statistical analysis was performed on this outcome measure. Additionally, due to concerns that the participant would be at risk of being re-identified, study results are not posted.|||||
855785|NCT02540356|Secondary|Occurrence of Serious Adverse Events (SAEs) and/or Treatment-emergent Adverse Events (TEAEs), Regardless of Causality or Relationship to Study Drug||Throughout the study period of approximately 22 months|Study was terminated early with only one participant dosed. No statistical analysis was performed on this outcome measure.||Participants|||Count of Participants
855896|NCT02410200|Primary|Change in the Number of New or Newly Enlarging T2 Hyperintense Lesions on Brain Magnetic Resonance Imaging (MRI) Scans From the Baseline Period to On-Treatment Assessment Period||Baseline Period (Week -8 to Day 0), On-Treatment Assessment Period (Week 16 to Week 24)|Primary Analysis Population: participants having new or newly enlarging T2 lesions during the Baseline period with a post-baseline assessment.||lesions||Standard Deviation|Mean
855786|NCT02540356|Secondary|Changes in Ascites-related Symptoms|Ascites related symptoms: anorexia, nausea, early satiety, vomiting, abdominal pain, abdominal swelling, dyspnea, fatigue, swollen ankles, heartburn|Baseline, weekly during the treatment period, and every 2 weeks during the safety follow-up period, up to approximately 6 months)|Study was terminated early with only one participant dosed. No statistical analysis was performed on this outcome measure. Additionally, due to concerns that the participant would be at risk of being re-identified, study results are not posted.|||||
855787|NCT02540356|Secondary|Change in Ascites Volume Per Unit Time With Treatment|The volume of ascites from the last dose of Imalumab to the first post-treatment paracentesis per unit time will be compared to the volume of the last pre-treatment paracentesis per unit time. At each paracentesis, the volume of fluid that can be removed safely (measured by ultrasound-guided paracentesis) to achieve close to dryness should be withdrawn, measured, and documented.|Up to 4 weeks|Study was terminated early with only one participant dosed. No statistical analysis was performed on this outcome measure. Additionally, due to concerns that the participant would be at risk of being re-identified, study results are not posted.|||||
855788|NCT02540356|Secondary|Ratio of Time to First Paracentesis Post-treatment Over Puncture-free Interval at Baseline|Time to first paracentesis post-treatment is calculated as the time between the last dose of Imalumab to subsequent first therapeutic paracentesis.|4 weeks|Study was terminated early with only one participant dosed. No statistical analysis was performed on this outcome measure. Additionally, due to concerns that the participant would be at risk of being re-identified, study results are not posted.|||||
855789|NCT02540356|Primary|The Ratio of Puncture Free Survival (PuFS) Over Puncture-free Interval at Baseline|"PuFS is defined as the time from the last dose of Imalumab to the first therapeutic paracentesis after that, or death, whichever occurs first.
Puncture-free interval at baseline is calculated as the time between the last 2 therapeutic paracenteses immediately before the first dose of Imalubmab."|4 weeks|Study was terminated early with only one participant dosed. No statistical analysis was performed on this outcome measure. Additionally, due to concerns that the participant would be at risk of being re-identified, study results are not posted.|||||
855790|NCT02540356|Primary|The Occurrence of Dose-limiting Toxicity (DLT)|"DLT is defined as any drug related treatment-emergent adverse event that occurs during the 28-day period after the first dose of Imalumab and that meets any of these criteria:
Any ≥ grade 3 non-hematologic toxicity assessed by the investigator as related to study drug (except: single lab value out of normal range not necessarily translating or considered a feature of clinical diagnosis requiring an intervention per investigator's interpretation and resolves to ≤ Grade 2 with adequate measure in 7 days; Transient grade 3 elevations of hepatic transaminases in the absence of simultaneous increase in serum bilirubin; Alopecia)
Any toxicity resulted in dose delay for ≥14 days
Any grade 4 hematologic toxicity (except lymphopenia)
Grade 3 febrile neutropenia
Grade 3 thrombocytopenia associated with bleeding
Any life-threatening complication/abnormality not covered in the NCICTCAE v4.03"|4 weeks|Study was terminated early with only one participant dosed. No statistical analysis was performed on this outcome measure.||Participants|||Count of Participants
855791|NCT02514473|Secondary|Average Pre-dose Concentration (Ctrough,Ave) and Average 3 to 6 Hours Post-dose Concentration (C3-6h,Ave) For Lumacaftor and Ivacaftor|Ctrough,ave is average of individual pre-dose observed concentrations across Week 4 and 24. C3-6h,ave is average of individual 3 to 6 hours post-dose observed concentrations across Day 1, 15 and Week 4. This outcome was not planned to be assessed in Placebo arm.|For Ctrough,ave: before morning dose on Week 4 and 24; For C3-6h,ave: 3 to 6 hours after morning dose on Day 1, 15 and Week 4|Pharmacokinetic (PK) set included all randomized participants who received any amount of study drug and had a PK assessment. Here, 'Number of participants analyzed' = those participants who were evaluable for this endpoint and 'Number Analyzed' = those participants who were evaluable at the specified time points for each arm, respectively.||Nanogram per milliliter (ng/mL)||Standard Deviation|Mean
855792|NCT02514473|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. AE includes serious as well as non-serious AEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, inpatient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Any AE that increased in severity or newly developed at or after initial dosing of study drug to Week 28 was considered treatment-emergent.|Baseline up to Week 28|Safety Set included all participants who were exposed to any amount of study drug.||participants|||Number
855793|NCT02514473|Secondary|Time-to-first Pulmonary Exacerbation|Time-to-first pulmonary exacerbation was analyzed using the Kaplan-Meier estimates. Pulmonary exacerbation was defined as the treatment with new or changed antibiotic therapy (intravenous, inhaled, or oral) for greater than or equal to 4 sinopulmonary signs/symptoms.|Baseline through Week 24|FAS.||Days||Inter-Quartile Range|Median
855794|NCT02514473|Secondary|Percentage of Participants With At Least 1 Pulmonary Exacerbation Event|Pulmonary exacerbation was defined as the treatment with new or changed antibiotic therapy (intravenous, inhaled, or oral) for greater than or equal to 4 sinopulmonary signs/symptoms.|Baseline through Week 24|FAS.||Percentage of participants|||Number
855795|NCT02514473|Secondary|Number of Pulmonary Exacerbation Events|Pulmonary exacerbation was defined as the treatment with new or changed antibiotic therapy (intravenous, inhaled, or oral) for greater than or equal to 4 sinopulmonary signs/symptoms. The number of events were reported.|Baseline through Week 24|FAS.||Pulmonary exacerbation events|||Number
855796|NCT02514473|Secondary|Absolute Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Domains Through Week 24|The TSQM is a 14-item self-administered questionnaire which measures participants’ experiences with their medication on four dimensions: effectiveness, side effects, convenience and global satisfaction. For each dimension, responses are added and transformed to a scale from 0 to 100, where higher scores indicate greater satisfaction.|Baseline, Through Week 24|FAS. Here, ‘Number of participants analyzed’ = those participants who were evaluable for this endpoint and ‘Number Analyzed’ = those participants who were evaluable at the specified time points for each arm, respectively.||Units on a scale||Standard Error|Least Squares Mean
855797|NCT02514473|Secondary|Absolute Change From Baseline in Height-for-age Z-score at Week 24|Z-score is a statistical measure to evaluate how a single data point compares to a standard. It describes whether a mean was above or below the standard. Height, adjusted for age and sex, was analyzed as height-for-age z-score (height z-score). The height-for-age z-scores were calculated using National Center for Health Statistics growth charts.|Baseline, Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.||Z-score||Standard Error|Least Squares Mean
855798|NCT02514473|Secondary|Absolute Change From Baseline in Height at Week 24||Baseline, Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.||Centimeter (cm)||Standard Error|Least Squares Mean
855799|NCT02514473|Secondary|Absolute Change From Baseline in Weight-for-age Z-score at Week 24|Z-score is a statistical measure to evaluate how a single data point compares to a standard. It describes whether a mean was above or below the standard. Weight, adjusted for age and sex, was analyzed as weight-for-age z-score (weight z-score). The weight-for-age z-scores were calculated using National Center for Health Statistics growth charts.|Baseline, Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.||Z-score||Standard Error|Least Squares Mean
855800|NCT02514473|Secondary|Absolute Change From Baseline in Weight at Week 24||Baseline, Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.||Kg||Standard Error|Least Squares Mean
855801|NCT02514473|Secondary|Absolute Change From Baseline in BMI-for-age Z-score at Week 24|BMI was defined as weight in kg divided by height in m^2. z-score is a statistical measure to evaluate how a single data point compares to a standard. It describes whether a mean was above or below the standard. BMI, adjusted for age and sex, was analyzed as BMI-for-age z-score (BMI z-score). The BMI-for-age z-scores were calculated using National Center for Health Statistics growth charts.|Baseline, Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.||Z-score||Standard Error|Least Squares Mean
855802|NCT02514473|Secondary|Relative Change From Baseline in ppFEV1 Through Week 24|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Wang standards were used to calculate ppFEV1 (for age, gender, race, and height).|Baseline, Through Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.||Percent change||Standard Error|Least Squares Mean
855803|NCT02514473|Secondary|Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Through Week 24|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Wang standards were used to calculate ppFEV1 (for age, gender, race, and height).|Baseline, Through Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.||Percent predicted of FEV1||Standard Error|Least Squares Mean
855804|NCT02514473|Secondary|Absolute Change From Baseline in Sweat Chloride at Week 24|Sweat samples were collected using an approved collection device.|Baseline, Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.||mmol/L||Standard Error|Least Squares Mean
855805|NCT02514473|Secondary|Absolute Change From Baseline in Lung Clearance Index 5.0 (LCI5.0) Through Week 24|LCI is a measure of ventilation inhomogeneity that is derived from a multiple breath washout test using Nitrogen (N2). LCI5.0 represents the number of lung turnovers required to reduce the end tidal inert gas concentration to 1/20th of its starting value.|Baseline, Through Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.||Ratio||Standard Error|Least Squares Mean
855806|NCT02514473|Secondary|Absolute Change From Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score Through Week 24|The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.|Baseline, Through Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.||Units on a scale||Standard Error|Least Squares Mean
855807|NCT02514473|Secondary|Absolute Change From Baseline in Body Mass Index (BMI) at Week 24|BMI was defined as weight in kg divided by height in square meter (m^2).|Baseline, Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.||Kg/m^2||Standard Error|Least Squares Mean
855808|NCT02514473|Secondary|Average Absolute Change From Baseline in Sweat Chloride at Day 15 and Week 4|Sweat samples were collected using an approved collection device. Baseline was defined as the average of the measurements at screening and on Day 1 pre-dose. Change from Baseline in sweat chloride at Day 15 and Week 4 was calculated. The average of the 2 values (Change at Day 15 and Week 4) was reported.|Baseline, Day 15 and Week 4|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.||Millimole per liter (mmol/L)||Standard Error|Least Squares Mean
855809|NCT02514473|Primary|Absolute Change From Baseline in Lung Clearance Index 2.5 (LCI2.5) Through Week 24|Lung clearance index (LCI) is a measure of ventilation inhomogeneity that is derived from a multiple breath washout test using Nitrogen (N2). LCI2.5 represents the number of lung turnovers required to reduce the end tidal inert gas concentration to 1/40th of its starting value.|Baseline, Through Week 24|Full Analysis Set (FAS) included all randomized participants who received any amount of study drug. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.||Ratio||Standard Error|Least Squares Mean
855829|NCT02476032|Secondary|Verbal Rating Scale: Mean Reduction in Sensitivity Between Groups|"An analysis of covariance model was used to compare mean reduction in sensitivity scores (SAS and VRS) between groups at each post-treatment time point. A linear mixed effect model with group, time and baseline score as fixed effects and a random subject effect was used to compare the sensitivity outcomes between groups across time. The effect of location was also examined using this model.
Verbal Rating Scale 0-10 Measurement of Participant's Perception of Pain
0 = No pain 1-3 = Mild Pain 4-6 = Moderate Pain 7-10 = Severe Pain"|30 Minutes Post, 4 Weeks Post, 8 Weeks Post Baseline|||units on a scale||Standard Error|Mean
855830|NCT02476032|Primary|Schiff Air Test: Mean Reduction in Sensitivity Between Groups|"An analysis of covariance model was used to compare mean reduction in sensitivity scores (SAS and VRS) between groups at each post-treatment time point. A linear mixed effect model with group, time and baseline score as fixed effects and a random subject effect was used to compare the sensitivity outcomes between groups across time. The effect of location was also examined using this model.
Schiff Air Scale 0-3 Measurement of Dentinal Hypersensitivity
0 Tooth/Patient did not respond to the air stimulus
Tooth/Patient responded to the air stimulus but did not request discontinuation of the stimulus
Tooth/Patient responded to the air stimulus and request discontinuation or moved from the stimulus
Tooth/Patient responded to the air stimulus, considered the stimulus painful, and requested discontinuation of the stimulus"|30 Minutes Post, 4 Weeks Post, 8 Weeks Post Baseline|||units on a scale||Standard Error|Mean
855895|NCT02410200|Secondary|Maximum Observed Plasma Concentration (Cmax)||Day 8|All participants who received at least 1 dose of BG00012 and had at least 1 pharmacokinetic parameter available.||ng/mL||Standard Deviation|Mean
855871|NCT02411578|Post-Hoc|Clinical Grading - Initial Treatment Correct|2 graders, blinded to treatment arm, independently graded each hypoglycemic event as a clinical failure or success based on all available BG concentrations within 1 hour of initial treatment. All BG values, along with corresponding time elapsed since treatment, were reviewed to determine whether the response would be considered a treatment success, in a clinical setting. There were no specific cut points; instead, it was a clinical assessment of the BG response. Discordant gradings (6% of events) were adjudicated by the graders to achieve a consensus grading. The number of events graded as a treatment success were reported out of the total number of hypoglycemic events, for each treatment arm.|60 minutes|"This analysis included all hypoglycemic events in which the initial treatment and dose were correct, irrespective of the timing of the BG measurements.
8 hypoglycemic events were deemed Indeterminate by the graders during the glucagon period and 4 during the glucose tabs period."||Hypoglycemic Events|Hypoglycemic Events||Count of Units
855872|NCT02411578|Post-Hoc|Clinical Grading - Initial and 15-min Treatment Correct|2 graders, blinded to treatment arm, independently graded each hypoglycemic event as a clinical failure or success based on all available BG concentrations within 1 hour of initial treatment. All BG values, along with corresponding time elapsed since treatment, were reviewed to determine whether the response would be considered a treatment success, in a clinical setting. There were no specific cut points; instead, it was a clinical assessment of the BG response. Discordant gradings (6% of events) were adjudicated by the graders to achieve a consensus grading. The number of events graded as a treatment success were reported out of the total number of hypoglycemic events, for each treatment arm.|60 minutes|"Analysis was limited to hypoglycemic events where Initial and 15-min Treatment were correct.
4 hypoglycemic events were deemed Indeterminate by the graders during the glucagon period."||Hypoglycemic Events|Hypoglycemic Events||Count of Units
855873|NCT02411578|Post-Hoc|Clinical Grading - Limited to Events in Primary Analysis|2 graders, blinded to treatment arm, independently graded each hypoglycemic event as a clinical failure or success based on all available BG concentrations within 1 hour of initial treatment. All BG values, along with corresponding time elapsed since treatment, were reviewed to determine whether the response would be considered a treatment success, in a clinical setting. There were no specific cut points; instead, it was a clinical assessment of the BG response. Discordant gradings (6% of events) were adjudicated by the graders to achieve a consensus grading. The number of events graded as a treatment success were reported out of the total number of hypoglycemic events, for each treatment arm.|60 minutes|Analysis was limited to hypoglycemic events included in the primary analysis. 3 hypoglycemic events were deemed Indeterminate by the graders during the glucagon period.||Hypoglycemic Events|Hypoglycemic Events||Count of Units
855874|NCT02411578|Secondary|CGM Coefficient of Variation|Coefficient of Variation from CGM data computed over entire 3 weeks of treatment period|3 weeks|Limited to participants who had at least 72 hours of CGM data during each period||percentage coefficient of variation||Inter-Quartile Range|Median
855875|NCT02411578|Secondary|CGM Time Below 70|Percentage of time <70 mg/dL from CGM data computed over entire 3 weeks of treatment period|3 weeks|Limited to participants who had at least 72 hours of CGM data during each period||percentage of time||Inter-Quartile Range|Median
855876|NCT02411578|Secondary|CGM Time in Range|Percentage of time 70-180 mg/dL from CGM data computed over entire 3 weeks of treatment period|3 weeks|Limited to participants who had at least 72 hours of CGM data during each period||percentage of time||Inter-Quartile Range|Median
855877|NCT02411578|Secondary|CGM Mean Glucose|Median (IQR) reported for mean glucose from CGM data computed over entire 3 weeks of treatment period|3 weeks|Limited to participants who had at least 72 hours of CGM data during each period||mg/dL||Inter-Quartile Range|Median
855878|NCT02411578|Secondary|CGM Time Below 70 mg/dL|Percentage of time <70 mg/dL from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first 2 hours after start of hypoglycemic event|120 Minutes|A participant had to have sufficient calibrations using study BGM to compare BGM and CGM data to ensure matching dates and times. Event level requirements: 1) initial treatment and dose had to be correct, 2) ≥6 CGM readings within 1 hour after initial treatment, and 3) first CGM glucose after the start of the hypoglycemic event had to be <80 mg/dL||percentage of time|Hypoglycemic Events|Inter-Quartile Range|Median
855879|NCT02411578|Secondary|CGM Time in Range, Event Level|Percentage of time 70-180 mg/dL from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first 2 hours after start of hypoglycemic event|120 Minutes|A participant had to have sufficient calibrations using study BGM to compare BGM and CGM data to ensure matching dates and times. Event level requirements: 1) initial treatment and dose had to be correct, 2) ≥6 CGM readings within 1 hour after initial treatment, and 3) first CGM glucose after the start of the hypoglycemic event had to be <80 mg/dL||percentage of time|Hypoglycemic Events|Inter-Quartile Range|Median
855880|NCT02411578|Secondary|CGM Mean Glucose, Event Level|Median (IQR) reported for mean glucose from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first 2 hours after start of hypoglycemic event|120 Minutes|A participant had to have sufficient calibrations using study BGM to compare BGM and CGM data to ensure matching dates and times. Event level requirements: 1) initial treatment and dose had to be correct, 2) ≥6 CGM readings within 1 hour after initial treatment, and 3) first CGM glucose after the start of the hypoglycemic event had to be <80 mg/dL||mg/dL|Hypoglycemic Events|Inter-Quartile Range|Median
855881|NCT02411578|Secondary|CGM Maximum Glucose, Event Level|Maximum glucose from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first 2 hours after start of hypoglycemic event|120 Minutes|A participant had to have sufficient calibrations using study BGM to compare BGM and CGM data to ensure matching dates and times. Event level requirements: 1) initial treatment and dose had to be correct, 2) ≥6 CGM readings within 1 hour after initial treatment, and 3) first CGM glucose after the start of the hypoglycemic event had to be <80 mg/dL||mg/dL|Hypoglycemic Events|Inter-Quartile Range|Median
855882|NCT02411578|Secondary|CGM Minimum Glucose, Event Level|Minimum glucose from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first 2 hours after start of hypoglycemic event|120 Minutes|A participant had to have sufficient calibrations using study BGM to compare BGM and CGM data to ensure matching dates and times. Event level requirements: 1) initial treatment and dose had to be correct, 2) ≥6 CGM readings within 1 hour after initial treatment, and 3) first CGM glucose after the start of the hypoglycemic event had to be <80 mg/dL||mg/dL|Hypoglycemic Events|Inter-Quartile Range|Median
855883|NCT02411578|Secondary|CGM Time Below 70 mg/dL, Event Level|Percentage of time <70 mg/dL from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first hour after start of hypoglycemic event|60 Minutes|A participant had to have sufficient calibrations using study BGM to compare BGM and CGM data to ensure matching dates and times. Event level requirements: 1) initial treatment and dose had to be correct, 2) ≥6 CGM readings within 1 hour after initial treatment, and 3) first CGM glucose after the start of the hypoglycemic event had to be <80 mg/dL||percentage of time|Hypoglycemic Events|Inter-Quartile Range|Median
855884|NCT02411578|Secondary|CGM Time in Range, Event Level|Percentage of time 70-180 mg/dL from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first hour after start of hypoglycemic event|60 Minutes|A participant had to have sufficient calibrations using study BGM to compare BGM and CGM data to ensure matching dates and times. Event level requirements: 1) initial treatment and dose had to be correct, 2) ≥6 CGM readings within 1 hour after initial treatment, and 3) first CGM glucose after the start of the hypoglycemic event had to be <80 mg/dL||percentage of time|Hypoglycemic Events|Inter-Quartile Range|Median
855885|NCT02411578|Secondary|CGM Mean Glucose, Event Level|Median (IQR) reported for mean glucose from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first hour after start of hypoglycemic event|60 Minutes|A participant had to have sufficient calibrations using study BGM to compare BGM and CGM data to ensure matching dates and times. Event level requirements: 1) initial treatment and dose had to be correct, 2) ≥6 CGM readings within 1 hour after initial treatment, and 3) first CGM glucose after the start of the hypoglycemic event had to be <80 mg/dL||mg/dL|Hypoglycemic Events|Inter-Quartile Range|Median
855886|NCT02411578|Secondary|CGM Maximum Glucose, Event Level|Maximum glucose from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first hour after start of hypoglycemic event|60 Minutes|A participant had to have sufficient calibrations using study BGM to compare BGM and CGM data to ensure matching dates and times. Event level requirements: 1) initial treatment and dose had to be correct, 2) ≥6 CGM readings within 1 hour after initial treatment, and 3) first CGM glucose after the start of the hypoglycemic event had to be <80 mg/dL||mg/dL|Hypoglycemic Events|Inter-Quartile Range|Median
855887|NCT02411578|Secondary|Continuous Glucose Monitor (CGM) Minimum Glucose, Event Level|Minimum glucose from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first hour after start of hypoglycemic event|60 Minutes|A participant had to have sufficient calibrations using study BGM to compare BGM and CGM data to ensure matching dates and times. Event level requirements: 1) initial treatment and dose had to be correct, 2) ≥6 CGM readings within 1 hour after initial treatment, and 3) first CGM glucose after the start of the hypoglycemic event had to be <80 mg/dL||mg/dL|Hypoglycemic Events|Inter-Quartile Range|Median
855888|NCT02411578|Primary|Number of Hypoglycemic Events ≥50 mg/dl 15 Minutes AND ≥ 70 mg/dl 30 Minutes After Initial Treatment||30 minutes|Limited to events with starting BG of 50-69 mg/dL||Hypoglycemic Events|Hypoglycemic Events||Count of Units
855889|NCT02410200|Secondary|Number of Participants Who Experienced Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: any untoward medical occurrence that does not necessarily have a causal relationship with treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above.|Up to Week 28|All participants who received at least 1 dose of BG00012.||participants|||Number
855890|NCT02410200|Secondary|Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf)||Day 8|All participants who received at least 1 dose of BG00012 and had at least 1 pharmacokinetic parameter available.||h*mcg/mL||Standard Deviation|Mean
855891|NCT02410200|Secondary|Half-Life Lambda z||Day 8|All participants who received at least 1 dose of BG00012 and had at least 1 pharmacokinetic parameter available.||hours||Standard Deviation|Mean
855892|NCT02410200|Secondary|Apparent Volume of Distribution (V/F)||Day 8|All participants who received at least 1 dose of BG00012 and had at least 1 pharmacokinetic parameter available.||L||Standard Deviation|Mean
855893|NCT02410200|Secondary|Apparent Clearance (CL/F)||Day 8|All participants who received at least 1 dose of BG00012 and had at least 1 pharmacokinetic parameter available.||L/h||Standard Deviation|Mean
855894|NCT02410200|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||Day 8|All participants who received at least 1 dose of BG00012 and had at least 1 pharmacokinetic parameter available.||hours||Standard Deviation|Mean
855902|NCT02317692|Secondary|Effects of Socioeconomic Status and Parental Acculturation on Treatment Outcomes (Parental Report)|Socioeconomic status computed based on parental report of education and occupation (assessed on demographic form). Acculturation based on parental report on the Acculturation Rating Scale for Mexican Americans-II and the Mexican American Cultural Values for Adolescents and Adults.|8 weeks|We did not examine this outcome measure due to a lack of variability on the SES and acculturation measure.|||||
855903|NCT02317692|Secondary|Change in Parental Functioning (Maternal Parenting Stress)|Pre-treatment to post-treatment change on summary score of Parenting Stress Index-Short Form (completed by mothers) Range=0-144; the larger the number, the greater stress Difference in mean pre and post scores for each group, so SD was not calculated.|8 weeks|Only mothers completed.||units on a scale|Families||Number
855904|NCT02317692|Secondary|Change in ADHD Symptoms (Inattention Subscale of Disruptive Behavior Disorders Rating Scale)|Pre-treatment to post-treatment change on inattention subscale of Disruptive Behavior Disorders Rating Scale (completed by parent) Range=0-3; the larger the number, the greater the symptoms Difference in mean pre and post scores for each group, so SD was not calculated.|Baseline to 8 weeks|||units on a scale|Families||Number
855905|NCT02317692|Primary|Acceptability of Treatment (Summary Score of Therapy Attitude Inventory)|Parental report of satisfaction with treatment (summary score of Therapy Attitude Inventory) Range=10-50; higher scores represent greater satisfaction (a better outcome)|8 weeks|||units on a scale|Families|Standard Deviation|Mean
855906|NCT02317692|Primary|Engagement in Treatment - Homework Completion (% of Completed Homework)|(recorded by clinician - homework was assigned every week and was expected to be returned at the next week's session)|8 weeks|||percentage of completed homework|Families|Standard Deviation|Mean
855907|NCT02317692|Primary|Engagement in Treatment - Sessions Attended|Number of sessions attended by each family (recorded by clinician)|8 weeks|||sessions|Families|Standard Deviation|Mean
855908|NCT02317692|Primary|Engagement in Treatment - Treatment Completion (Number of Families Who Completed Treatment)|Number of families who completed treatment (recorded by clinician)|8 weeks|||Families|Families||Count of Units
856062|NCT01942590|Secondary|Change in 6 Minute Walk Test|Assess exercise tolerance in study patients; test administered by physical therapist. Subjects were asked to walk for 6 minutes, unassisted. The distance walked was recorded in meters.|Baseline, week 18|Participants who completed 6 minute walk test||meters||Standard Deviation|Mean
855920|NCT02283268|Secondary|Pharmacokinetics: Volume of Distribution at Steady State (Vss)|"This assessment is only required for subjects undergoing major surgery. Subjects will receive a PK infusion at a dose of 50±5 IU/kg rVWF:RCo within 42 days prior to surgery. Vss will be calculated as the clearance multiplied with the mean residence time.
PK analysis was performed for the following analytes:
VWF Ristocetin Cofactor Activity (VWF:RCo), VWF Antigen Activity (VWF:Ag), VWF Collagen Binding Activity (VWF:CB), VWF Activity Measured INNOVANCE VWF Ac Assay (VWF:Ac)"|PK measurements were done within 30 minutes pre-infusion, and post infusion at 30 (± 5) minutes, 60 (± 5) minutes, 6 (± 1) hours, 12 (± 1) hours, 24 (± 2) hours, 48 (± 2) hours and 72 (± 2) hours.|The PK analysis data set, including all participants who underwent PK assessment with data collected at the relevant time points, was used for analysis of this outcome measure.||dL/kg||Geometric Coefficient of Variation|Geometric Mean
855921|NCT02283268|Secondary|Pharmacokinetics: Elimination Phase Half-life (T1/2)|"This assessment is only required for subjects undergoing major surgery. Subjects will receive a PK infusion at a dose of 50±5 IU/kg rVWF:RCo within 42 days prior to surgery. Terminal or disposition half-life (T1/2) will be calculated as ln2/λz where λz is the terminal elimination rate constant as calculated in WinNonlin NCA using at least three quantifiable concentrations.
PK analysis was performed for the following analytes:
VWF Ristocetin Cofactor Activity (VWF:RCo), VWF Antigen Activity (VWF:Ag), VWF Collagen Binding Activity (VWF:CB), VWF Activity Measured INNOVANCE VWF Ac Assay (VWF:Ac)"|PK measurements were done within 30 minutes pre-infusion, and post infusion at 30 (± 5) minutes, 60 (± 5) minutes, 6 (± 1) hours, 12 (± 1) hours, 24 (± 2) hours, 48 (± 2) hours and 72 (± 2) hours.|The PK analysis data set, including all participants who underwent PK assessment with data collected at the relevant time points, was used for analysis of this outcome measure.||hours||Geometric Coefficient of Variation|Geometric Mean
855929|NCT02283268|Secondary|Occurrence of Severe Allergic Reactions (eg, Anaphylaxis)|Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) will be evaluated for severe allergic reactions.|From first infusion of investigational product through study completion (ie, 14 (± 2) days post surgery)|The safety analysis data set, including all participants who received any amount of investigational product, was used for analysis of this outcome measure.||Adverse Events|||Number
855930|NCT02283268|Secondary|Occurrence of Thrombotic Events|Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) will be evaluated for thrombotic events.|From first infusion of investigational product through study completion (ie, 14 (± 2) days post surgery)|The safety analysis data set, including all participants who received any amount of investigational product, was used for analysis of this outcome measure.||Adverse Events|||Number
855922|NCT02283268|Secondary|Pharmacokinetics: Incremental Recovery (IR)|"This assessment is only required for subjects undergoing major surgery. Subjects will receive a PK infusion at a dose of 50±5 IU/kg rVWF:RCo within 42 days prior to surgery. Incremental recovery will be calculated as (Cmax minus Cpreinfusion) divided by the dose (IU/kg) where kg refers to the body weight at the time of dosing and Cmax is the observed maximum concentration before correction for pre-infusion values.
PK analysis was performed for the following analytes:
VWF Ristocetin Cofactor Activity (VWF:RCo), VWF Antigen Activity (VWF:Ag), VWF Collagen Binding Activity (VWF:CB), VWF Activity Measured INNOVANCE VWF Ac Assay (VWF:Ac)"|PK measurements were done within 30 minutes pre-infusion, and post infusion at 30 (± 5) minutes, 60 (± 5) minutes, 6 (± 1) hours, 12 (± 1) hours, 24 (± 2) hours, 48 (± 2) hours and 72 (± 2) hours.|The PK analysis data set, including all participants who underwent PK assessment with data collected at the relevant time points, was used for analysis of this outcome measure.||IU/dL||Standard Deviation|Mean
855923|NCT02283268|Secondary|Pharmacokinetics: Clearance (CL)|"This assessment is only required for subjects undergoing major surgery. Subjects will receive a PK infusion at a dose of 50±5 IU/kg rVWF:RCo within 42 days prior to surgery. Clearance will be calculated as dose (IU/kg) divided by the area under the curve time 0 to infinity.
PK analysis was performed for the following analytes:
VWF Ristocetin Cofactor Activity (VWF:RCo), VWF Antigen Activity (VWF:Ag), VWF Collagen Binding Activity (VWF:CB), VWF Activity Measured INNOVANCE VWF Ac Assay (VWF:Ac)"|PK measurements were done within 30 minutes pre-infusion, and post infusion at 30 (± 5) minutes, 60 (± 5) minutes, 6 (± 1) hours, 12 (± 1) hours, 24 (± 2) hours, 48 (± 2) hours and 72 (± 2) hours.|The PK analysis data set, including all participants who underwent PK assessment with data collected at the relevant time points, was used for analysis of this outcome measure.||dL/hour/kg||Geometric Coefficient of Variation|Geometric Mean
855924|NCT02283268|Secondary|Pharmacokinetics: Mean Residence Time (MRT)|"This assessment is only required for subjects undergoing major surgery. Subjects will receive a PK infusion at a dose of 50±5 IU/kg rVWF:RCo within 42 days prior to surgery. Mean residence time will be calculated as area under the first moment curve from time 0 to infinity divided by the area under the curve time 0 to infinity minus T/2 where T is the duration of the infusion.
PK analysis was performed for the following analytes:
VWF Ristocetin Cofactor Activity (VWF:RCo), VWF Antigen Activity (VWF:Ag), VWF Collagen Binding Activity (VWF:CB), VWF Activity Measured INNOVANCE VWF Ac Assay (VWF:Ac)"|PK measurements were done within 30 minutes pre-infusion, and post infusion at 30 (± 5) minutes, 60 (± 5) minutes, 6 (± 1) hours, 12 (± 1) hours, 24 (± 2) hours, 48 (± 2) hours and 72 (± 2) hours.|The PK analysis data set, including all participants who underwent PK assessment with data collected at the relevant time points, was used for analysis of this outcome measure.||hours||Geometric Coefficient of Variation|Geometric Mean
855925|NCT02283268|Secondary|Pharmacokinetics: Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity (AUC 0-∞ /Dose)|"This assessment is only required for subjects undergoing major surgery. Subjects will receive a PK infusion at a dose of 50±5 IU/kg rVWF:RCo within 42 days prior to surgery. The area under the plasma concentration/time curve from time 0 to infinity and the area under the first moment curve from time 0 to infinity will be calculated as the sum of AUC or AUMC from time 0 to the time of last quantifiable concentration plus a tail area correction calculated as Ct/λz and Ct/λz(t+1/λz), respectively, where Ct is the last quantifiable concentration, t is the time of last quantifiable concentration and λz is the terminal or disposition rate constant.
PK analysis was performed for the following analytes:
VWF Ristocetin Cofactor Activity (VWF:RCo), VWF Antigen Activity (VWF:Ag), VWF Collagen Binding Activity (VWF:CB), VWF Activity Measured INNOVANCE VWF Ac Assay (VWF:Ac), FVIII Coagulation Activity (FVIII:C)"|PK measurements were done within 30 minutes pre-infusion, and post infusion at 30 (± 5) minutes, 60 (± 5) minutes, 6 (± 1) hours, 12 (± 1) hours, 24 (± 2) hours, 48 (± 2) hours and 72 (± 2) hours.|The PK analysis data set, including all participants who underwent PK assessment with data collected at the relevant time points, was used for analysis of this outcome measure.||hours*IU/dL||Geometric Coefficient of Variation|Geometric Mean
855926|NCT02283268|Secondary|Pharmacokinetics: Area Under the Plasma Concentration Versus Time Curve From 0 to 72 Hours Post-infusion (AUC 0-72 h/Dose)|"This assessment is only required for subjects undergoing major surgery. Subjects will receive a PK infusion at a dose of 50±5 IU/kg rVWF:RCo within 42 days prior to surgery. The area under the plasma concentration/time curve from 0 to 72 hours post-infusion will be computed using the linear trapezoidal rule. For the calculation of AUC(0-72h) the levels at 72 hours will be linearly interpolated/extrapolated from the 2 nearest sampling time points.
PK analysis was performed for the following analytes:
VWF Ristocetin Cofactor Activity (VWF:RCo), VWF Antigen Activity (VWF:Ag), VWF Collagen Binding Activity (VWF:CB), VWF Activity Measured INNOVANCE VWF Ac Assay (VWF:Ac), FVIII Coagulation Activity (FVIII:C)"|PK measurements were done within 30 minutes pre-infusion, and post infusion at 30 (± 5) minutes, 60 (± 5) minutes, 6 (± 1) hours, 12 (± 1) hours, 24 (± 2) hours, 48 (± 2) hours and 72 (± 2) hours.|The PK analysis data set, including all participants who underwent PK assessment with data collected at the relevant time points, was used for analysis of this outcome measure.||hours*IU/dL||Geometric Coefficient of Variation|Geometric Mean
855927|NCT02283268|Secondary|Number of Participants Who Developed Antibodies to Chinese Hamster Ovary (CHO) Proteins, Mouse Immunoglobulin G (IgG) or Recombinant Furin (rFurin)|Participants were treated with recombinant van Willebrand Factor (rVWF) with or without ADVATE.|Testing occurred throughout the study at screening, prior PK infusion, pre-surgery, post surgery in case of excessive bleeding or unexplained bleeding, at postoperative day 7 and at study completion visit (ie. 14 (± 2) days post surgery).|The safety analysis data set, including all participants who received any amount of investigational product, was used for analysis of this outcome measure.||Participants|||Count of Participants
855928|NCT02283268|Secondary|Number of Participants Who Developed Inhibitory and Total Binding Antibodies to Von Willebrand Factor (VWF) and Inhibitory Antibodies to Factor VIII (FVIII)|Participants were treated with recombinant van Willebrand Factor (rVWF) with or without ADVATE.|Testing occurred throughout the study at screening, prior PK infusion, pre-surgery, post surgery in case of excessive bleeding or unexplained bleeding, at postoperative day 7 and at study completion visit (ie. 14 (± 2) days post surgery).|The safety analysis data set, including all participants who received any amount of investigational product, was used for analysis of this outcome measure.||Participants|||Count of Participants
856362|NCT01485796|Primary|Rate of Related Systemic Adverse Events (Excluding Infections) Per Infusion|A point estimate and 95% confidence interval for the rate of related systemic adverse events per infusion was derived using a Poisson model.|7 months (per subject)|||adverse events||95% Confidence Interval|Number
855931|NCT02283268|Secondary|Occurrence of Adverse Events|Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) will be evaluated.|From first infusion of investigational product through study completion (ie, 14 (± 2) days post surgery)|The safety analysis data set, including all participants who received any amount of investigational product, was used for analysis of this outcome measure.||Adverse Events|||Number
855932|NCT02283268|Secondary|Daily Intra- and Postoperative Weight-adjusted Dose of rVWF With or Without ADVATE||Daily, from day of surgery through postoperative Day 14 (± 2 days)|Number of participants analyzed is different for the time points according to individual treatment. The full analysis data set, including all participants who received investigational product and have at least 1 hemostatic assessment, was used for analysis.||IU/kg||Inter-Quartile Range|Median
855933|NCT02283268|Secondary|Intraoperative Hemostatic Efficacy Score as Assessed by the Operating Surgeon|"Hemostatic efficacy will be rated on a scale of excellent - good - moderate - none.
Excellent: Intraoperative hemostasis achieved with rVWF with our without ADVATE was as good or better than that expected for the type of surgical procedure performed in a hemostatically normal subject.
Good: Intraoperative hemostasis achieved with rVWF with or without ADVATE was probably as good as that expected for the type of surgical procedure performed in a hemostatically normal subject.
Moderate: Intraoperative hemostasis with rVWF with or without ADVATE was clearly less than optimal for the type of procedure performed but was maintained without the need to change the rVWF concentrate.
None: Participant experienced uncontrolled bleeding that was the result of inadequate therapeutic response despite proper dosing, necessitating a change of rVWF concentrate."|Day 0 (at completion of surgery)|Number of participants with major, minor and oral surgery and number of participant with Von Willebrand Type 1, 2A, 2B, 2M and 3 do sum up to the overall number of participants analyzed. The full analysis data set, including all participants who received investigational product and have at least 1 hemostatic assessment, was used for analysis.||Participants|||Count of Participants
855934|NCT02283268|Secondary|Intraoperative Actual Versus Predicted Blood Loss Score as Assessed by the Operating Surgeon|"Hemostatic efficacy will be rated on a scale of excellent - good - moderate - none.
Excellent: Intraoperative blood loss was less than or equal to the maximum blood loss expected for the type of procedure performed in a hemostatically normal subject (≤ 100%).
Good: Intraoperative blood loss was up to 50% more than the maximum expected blood loss for the type of procedure performed in a hemostatically normal subject (101-150%) Moderate: Intraoperative blood loss was more than 50% of the maximum expected blood loss for the type of procedure performed in a hemostatically normal subject (>150%).
None: Uncontrolled hemorrhage that was the result of inadequate therapeutic response despite proper dosing, necessitating a change of clotting factor replacement regimen."|Day 0 (at completion of surgery)|Number of participants with major, minor and oral surgery and number of participant with Von Willebrand Type 1, 2A, 2B, 2M and 3 do sum up to the overall number of participants analyzed. The full analysis data set, including all participants who received investigational product and have at least 1 hemostatic assessment, was used for analysis.||Participants|||Count of Participants
855935|NCT02283268|Secondary|Intraoperative Actual Blood Loss Relative to Predicted Blood Loss|Actual blood loss relative to predicted blood loss will be calculated as [Actual Blood loss (mL)] divided by [Predicted Blood Loss (mL) multiplied by 100.|Day 0 (at completion of surgery)|Number of participants analyzed is 11, as for 3 participants the actual and the predicted blood loss was zero and for 1 participant the predicted blood loss was not collected. Therefore 'actual blood loss relative to predicted blood loss' could not be calculated. The full analysis data set was used for the analysis of this outcome measure.||Percent||Standard Deviation|Mean
855936|NCT02283268|Secondary|Intraoperative Actual Versus Predicted Blood Loss as Assessed by the Operating Surgeon|"The predicted blood loss will be estimated preoperatively by the operating surgeon based on a hemostatically normal individual of the same sex, age, stature and co-morbidities as the participant.
The actual blood loss will be assessed consisting of the estimated blood loss, including into swabs, towels and suction during the procedure, per the anesthesiologist's record."|Day 0 (at completion of surgery)|For predicted blood loss the number of participants analyzed is 14 as for one participant (included in the major surgery reporting group) the predicted blood loss was not collected. The full analysis data set, including all participants who received investigational product and have at least 1 hemostatic assessment, was used for analysis.||mL||Standard Deviation|Mean
855937|NCT02283268|Primary|Overall Hemostatic Efficacy as Assessed by the Investigator (Hemophilia Physician)|"Hemostatic efficacy will be rated on a scale of excellent - good - moderate - none.
Excellent: Intra-, and postoperative hemostasis achieved with rVWF with our without ADVATE was as good or better than that expected for the type of surgical procedure performed in a hemostatically normal subject.
Good: Intra-, and postoperative hemostasis achieved with rVWF with or without ADVATE was probably as good as that expected for the type of surgical procedure performed in a hemostatically normal subject.
Moderate: Intra-, and postoperative hemostasis with rVWF with or without ADVATE was clearly less than optimal for the type of procedure performed but was maintained without the need to change the rVWF concentrate.
None: Participant experienced uncontrolled bleeding that was the result of inadequate therapeutic response despite proper dosing, necessitating a change of rVWF concentrate."|24 hours after last peri-operative infusion or at completion of Day 14 (± 2 days) visit, whichever occurs earlier|Number of participants with major, minor and oral surgery and number of participant with Von Willebrand Type 1, 2A, 2B, 2M and 3 do sum up to the overall number of participants analyzed. The full analysis data set, including all participants who received investigational product and have at least 1 hemostatic assessment, was used for analysis.||Participants|||Count of Participants
856063|NCT01942590|Primary|Number of Participants With a Change in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Bilirubin Representing Liver Toxicity|Liver toxicity, as defined by a >3x increase in AST or ALT from the respective baseline values and/or an increase in direct, indirect or total bilirubin of >3x the upper limit of normal|Baseline, week 18, and week 52|||participants|||Number
856064|NCT01942590|Primary|Number of Participants With a Change in Creatine Kinase (CK) Reflecting Worsening of Muscle Involvement|Worsening muscle involvement, as defined by >3x increase in CK from baseline that is >2x the upper limit of normal|Baseline, week 18, and week 52|||participants|||Number
855964|NCT02210091|Post-Hoc|Pharmacokinetics (PK): Plasma Half-life Ratio of BAX 855 to ADVATE|This is a descriptive summary of the ratio of plasma half-life in the same subject for BAX 855 compared to ADVATE based on the final covariate model (first observation tabulation).|(1) within 30 min pre-infusion; (2) 15-30 min post-infusion; (3) Day 0 either 4 or 7 hours post-infusion; Day 1 am; Day 1 pm; (4) Day 2; Day 3; or Day 4|Pharmacokinetic (PK) Analysis Set||hours (hr)||Full Range|Mean
855965|NCT02210091|Secondary|Pharmacokinetics (PK): Incremental Recovery (IR) of BAX 855 Over Time - Chromogenic Assay|"Pre- and post-infusion levels of Factor VIII (FVIII) following infusion of BAX 855 were used to determine IR.
For participants who underwent PK evaluation, baseline IR was determined from the IR measurement used in the PK analysis. Refer to data in Outcome measure 21- Pharmacokinetics (PK): Incremental Recovery (IR), for the category Chromogenic assay - BAX 855
For participants who did not undergo a PK evaluation, baseline IR was determined at the baseline visit prior to the prophylactic treatment phase and is included in this outcome measure.
Category title includes number of participants [n] < 6 yrs; ≥6 to <12 yrs and the Full Analysis Set, respectively."|Baseline, Week 5 (or 10-15 Exposure Days [EDs], whichever occurs last), Week 12, and Month 6 (Completion/Termination)|Participants from the Full Analysis Set who provided at least data from baseline, Week 5 (or 10-15 EDs, whichever occurred last), Week 12 or Month 6.||IU/dL : IU/kg||Standard Deviation|Mean
855966|NCT02210091|Secondary|Pharmacokinetics (PK): Incremental Recovery (IR) of BAX 855 Over Time - One Stage Clotting Assay|"Pre- and post-infusion levels of Factor VIII (FVIII) following infusion of BAX 855 were used to determine IR.
For participants who underwent PK evaluation, baseline IR was determined from the IR measurement used in the PK analysis. Refer to data in Outcome measure 21- Pharmacokinetics (PK): Incremental Recovery (IR), for the category One stage clotting assay - BAX 855
For participants who did not undergo a PK evaluation, baseline IR was determined at the baseline visit prior to the prophylactic treatment phase and is included in this outcome measure.
Category title includes number of participants [n] < 6 yrs; ≥6 to <12 yrs and the Full Analysis Set, respectively."|Baseline, Week 5 (or 10-15 EDs, whichever occurs last), Week 12, and Month 6 (Completion/Termination)|Participants from the Full Analysis Set who provided at least data from baseline, Week 5 (or 10-15 EDs, whichever occurred last), Week 12 or Month 6||IU/dL : IU/kg||Standard Deviation|Mean
856363|NCT01485796|Primary|Number of Related Systemic Adverse Events (Excluding Infections)||7 months (per subject)|||adverse events|||Number
855967|NCT02210091|Secondary|Pharmacokinetics (PK): Incremental Recovery (IR)|"The first PK infusion was ADVATE and the second PK infusion was BAX 855. All participants undergoing PK assessment had a 72-hour washout period before administration of ADVATE and BAX 855. There were 4 blood draws for PK analysis-1 pre-infusion and 3 post infusion. The timing of the infusion (morning [am] or afternoon [pm]) and the timing of Blood Draws 3 and 4 (3 groups for each blood draw) were determined at randomization.
The sequence was as follows:- Blood Draw 1. within 30 minutes pre-infusion [Day 0]; PK INFUSION - am or pm [Day 0]; Blood Draw 2. 15-30 minutes post-infusion [Day 0]; Blood Draw 3. 3 groups:- 7 hours post-infusion (if am PK infusion) or 4 hours post-infusion (if pm PK infusion) [Day 0], Day 1 am or Day 1 pm; Blood Draw 4. 3 groups:- Day 2, Day 3 or Day 4. A non-compartmental model approach was implemented to analyze IR data. A one-stage clotting assay was used as the primary assay and a chromogenic assay was used to provide supportive data."|(1) within 30 min pre-infusion; (2) 15-30 min post-infusion; (3) Day 0 either 4 or 7 hours post-infusion; Day 1 am; Day 1 pm; (4) Day 2; Day 3; or Day 4|Pharmacokinetic (PK) Analysis Set||IU/dL : IU/kg||Standard Deviation|Mean
855968|NCT02210091|Secondary|Pharmacokinetics (PK): Volume of Distribution at Steady State (Vss)|"The first PK infusion was ADVATE and the second PK infusion was BAX 855. All participants undergoing PK assessment had a 72-hour washout period before administration of ADVATE and BAX 855. There were 4 blood draws for PK analysis-1 pre-infusion and 3 post infusion. The timing of the infusion (morning [am] or afternoon [pm]) and the timing of Blood Draws 3 and 4 (3 groups for each blood draw) were determined at randomization.
The sequence was as follows:- Blood Draw 1. within 30 minutes pre-infusion [Day 0]; PK INFUSION - am or pm [Day 0]; Blood Draw 2. 15-30 minutes post-infusion [Day 0]; Blood Draw 3. 3 groups:- 7 hours post-infusion (if am PK infusion) or 4 hours post-infusion (if pm PK infusion) [Day 0], Day 1 am or Day 1 pm; Blood Draw 4. 3 groups:- Day 2, Day 3 or Day 4. A nonlinear mixed effects model approach (population PK) was implemented to analyze PK data. A one-stage clotting assay was used as the primary assay and a chromogenic assay was used to provide supportive data."|(1) within 30 min pre-infusion; (2) 15-30 min post-infusion; (3) Day 0 either 4 or 7 hours post-infusion; Day 1 am; Day 1 pm; (4) Day 2; Day 3; or Day 4|Pharmacokinetic (PK) Analysis Set||litre (L)||Standard Deviation|Mean
855969|NCT02210091|Secondary|Pharmacokinetics (PK): Plasma Half-life (T1/2)|"The first PK infusion was ADVATE and the second PK infusion was BAX 855. All participants undergoing PK assessment had a 72-hour washout period before administration of ADVATE and BAX 855. There were 4 blood draws for PK analysis-1 pre-infusion and 3 post infusion. The timing of the infusion (morning [am] or afternoon [pm]) and the timing of Blood Draws 3 and 4 (3 groups for each blood draw) were determined at randomization.
The sequence was as follows:- Blood Draw 1. within 30 minutes pre-infusion [Day 0]; PK INFUSION - am or pm [Day 0]; Blood Draw 2. 15-30 minutes post-infusion [Day 0]; Blood Draw 3. 3 groups:- 7 hours post-infusion (if am PK infusion) or 4 hours post-infusion (if pm PK infusion) [Day 0], Day 1 am or Day 1 pm; Blood Draw 4. 3 groups:- Day 2, Day 3 or Day 4. A nonlinear mixed effects model approach (population PK) was implemented to analyze PK data. A one-stage clotting assay was used as the primary assay and a chromogenic assay was used to provide supportive data."|(1) within 30 min pre-infusion; (2) 15-30 min post-infusion; (3) Day 0 either 4 or 7 hours post-infusion; Day 1 am; Day 1 pm; (4) Day 2; Day 3; or Day 4|Pharmacokinetic (PK) Analysis Set||hours (hr)||Standard Deviation|Mean
855970|NCT02210091|Secondary|Pharmacokinetics (PK): Clearance (CL)|"The first PK infusion was ADVATE and the second PK infusion was BAX 855. All participants undergoing PK assessment had a 72-hour washout period before administration of ADVATE and BAX 855. There were 4 blood draws for PK analysis-1 pre-infusion and 3 post infusion. The timing of the infusion (morning [am] or afternoon [pm]) and the timing of Blood Draws 3 and 4 (3 groups for each blood draw) were determined at randomization.
The sequence was as follows:- Blood Draw 1. within 30 minutes pre-infusion [Day 0]; PK INFUSION - am or pm [Day 0]; Blood Draw 2. 15-30 minutes post-infusion [Day 0]; Blood Draw 3. 3 groups:- 7 hours post-infusion (if am PK infusion) or 4 hours post-infusion (if pm PK infusion) [Day 0], Day 1 am or Day 1 pm; Blood Draw 4. 3 groups:- Day 2, Day 3 or Day 4. A nonlinear mixed effects model approach (population PK) was implemented to analyze PK data. A one-stage clotting assay was used as the primary assay and a chromogenic assay was used to provide supportive data."|(1) within 30 min pre-infusion; (2) 15-30 min post-infusion; (3) Day 0 either 4 or 7 hours post-infusion; Day 1 am; Day 1 pm; (4) Day 2; Day 3; or Day 4|Pharmacokinetic (PK) Analysis Set||L/hr||Standard Deviation|Mean
855971|NCT02210091|Secondary|Pharmacokinetics (PK): Mean Residence Time (MRT)|"The first PK infusion was ADVATE and the second PK infusion was BAX 855. All participants undergoing PK assessment had a 72-hour washout period before administration of ADVATE and BAX 855. There were 4 blood draws for PK analysis-1 pre-infusion and 3 post infusion. The timing of the infusion (morning [am] or afternoon [pm]) and the timing of Blood Draws 3 and 4 (3 groups for each blood draw) were determined at randomization.
The sequence was as follows:- Blood Draw 1. within 30 minutes pre-infusion [Day 0]; PK INFUSION - am or pm [Day 0]; Blood Draw 2. 15-30 minutes post-infusion [Day 0]; Blood Draw 3. 3 groups:- 7 hours post-infusion (if am PK infusion) or 4 hours post-infusion (if pm PK infusion) [Day 0], Day 1 am or Day 1 pm; Blood Draw 4. 3 groups:- Day 2, Day 3 or Day 4. A nonlinear mixed effects model approach (population PK) was implemented to analyze PK data. A one-stage clotting assay was used as the primary assay and a chromogenic assay was used to provide supportive data."|(1) within 30 min pre-infusion; (2) 15-30 min post-infusion; (3) Day 0 either 4 or 7 hours post-infusion; Day 1 am; Day 1 pm; (4) Day 2; Day 3; or Day 4|Pharmacokinetic (PK) Analysis Set||hours (hr)||Standard Deviation|Mean
855972|NCT02210091|Secondary|Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve From 0 to ∞ Hours Post-infusion Per Dose, (AUC0-∞/Dose)||(1) within 30 min pre-infusion; (2) 15-30 min post-infusion; (3) Day 0 either 4 or 7 hours post-infusion; Day 1 am; Day 1 pm; (4) Day 2; Day 3; or Day 4|The PK parameters were derived using a non-compartmental estimation approach using a flexible sampling design to provide point and interval estimates for summary PK parameter using a batch method. AUC/Dose is not a standard output parameter so this calculation was not done.|||||
856015|NCT01987908|Secondary|Brief Pain Inventory (BPI): Interference of Pain With Aspects of Life (General Activity) During Post-treatment Observation Period - Change From Baseline|"Participants rated the degree to which their pain interfered with various daily functions by using the BPI short form. Interference with general activity was rated on a scale from 0 (does not interfere) to 10 (completely interferes).
Baseline was defined as the most recent value obtained prior to the start of the dosing on Day 1 of the double-blind dosing period."|At baseline and Day 49 during the post-treatment observation period|Participants who provided baseline data and at least one other data point for this outcome measure.||score on a scale||Standard Deviation|Mean
855973|NCT02210091|Secondary|Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve From 0 to ∞ Hours Post-infusion (AUC0-∞)|"The first PK infusion was ADVATE and the second PK infusion was BAX 855. All participants undergoing PK assessment had a 72-hour washout period before administration of ADVATE and BAX 855. There were 4 blood draws for PK analysis-1 pre-infusion and 3 post infusion. The timing of the infusion (morning [am] or afternoon [pm]) and the timing of Blood Draws 3 and 4 (3 groups for each blood draw) were determined at randomization.
The sequence was as follows:- Blood Draw 1. within 30 minutes pre-infusion [Day 0]; PK INFUSION - am or pm [Day 0]; Blood Draw 2. 15-30 minutes post-infusion [Day 0]; Blood Draw 3. 3 groups:- 7 hours post-infusion (if am PK infusion) or 4 hours post-infusion (if pm PK infusion) [Day 0], Day 1 am or Day 1 pm; Blood Draw 4. 3 groups:- Day 2, Day 3 or Day 4. A nonlinear mixed effects model approach (population PK) was implemented to analyze PK data. A one-stage clotting assay was used as the primary assay and a chromogenic assay was used to provide supportive data."|(1) within 30 min pre-infusion; (2) 15-30 min post-infusion; (3) Day 0 either 4 or 7 hours post-infusion; Day 1 am; Day 1 pm; (4) Day 2; Day 3; or Day 4|Pharmacokinetic (PK) Analysis Set.||IU•hr/L||Standard Deviation|Mean
855974|NCT02210091|Secondary|Positive Post-baseline Binding Antibodies to Factor VIII (FVIII), Polyethylene Glycol-Factor VIII (PEG-FVIII), PEG and Chinese Hamster Ovary (CHO) Proteins|"Binding antibodies to FVIII and PEG-FVIII, as well as to PEG, were measured using enzyme-linked immunosorbent assay (ELISA). Both immunoglobulin G (IgG) and immunoglobulin M (IgM) binding antibodies for FVIII, BAX 855, and PEG were tested at each study visit. Testing for binding antibodies to CHO was performed on citrate-anti-coagulated plasma using an ELISA employing polyclonal anti-human IgG antibodies.
This outcome measure includes antibodies that were transient (antibody developed after exposure to BAX 855 but not present at study termination/completion) and pre-existent (antibody originally present before exposure to BAX 855)."|After first exposure to BAX 855 until completion of study - approx. 6 months per participant.|BAX 855 Safety Analysis Set: Data not available for 1 participant in the 6 to <12 years group as participant was prematurely withdrawn from study.||participants|||Number
855975|NCT02210091|Secondary|Number of Clinically Significant Changes in Clinical Laboratory Parameters (Hematology, Clinical Chemistry, Lipids)|"The HEMATOLOGY PANEL consisted of complete blood count: hemoglobin, hematocrit, erythrocytes (ie, red blood cell count), leukocytes (ie, white blood cell count) with differential (ie, basophils, eosinophils, lymphocytes, monocytes, and neutrophils), mean corpuscular volume, mean corpuscular hemoglobin concentration, and platelet count.
The CLINICAL CHEMISTRY PANEL consisted of sodium, potassium, chloride, bicarbonate, total protein, albumin, ALT, aspartate aminotransferase (AST), total bilirubin, alkaline phosphatase, blood urea nitrogen, creatinine, and glucose.
The LIPID PANEL consisted of cholesterol, very low density lipoprotein, low density lipoprotein, high density lipoprotein, and triglycerides.
For each laboratory parameter value that changed from normal at baseline to abnormal at any subsequent study visit, the Investigator determined if the value was clinically significant, or not."|After first exposure to BAX 855 until completion of study - approx. 6 months per participant.|BAX 855 Safety Analysis Set.||clinically significant findings|||Number
855976|NCT02210091|Secondary|Number of Participants With Clinically Significant Changes in Vital Signs|Vital signs: body temperature (°C), respiratory rate (breaths/min), pulse rate (beats/min), and systolic and diastolic blood pressure (mmHg). For each vital sign value that changed from normal at baseline to abnormal at any subsequent study visit, the Investigator determined if the value was clinically significant (i.e. and adverse event), or not.|After first exposure to BAX 855 until completion of study - approx. 6 months per participant.|BAX 855 Safety Analysis Set.||participants|||Number
855977|NCT02210091|Secondary|Non-serious Adverse Events Possibly or Probably Related to BAX 855||After first exposure to BAX 855 until completion of study - approx. 6 months per participant.|BAX 855 Safety Analysis Set.||adverse events|||Number
855978|NCT02210091|Secondary|Serious Adverse Events (SAEs) Possibly or Probably Related to BAX 855||After first exposure to BAX 855 until completion of study - approx. 6 months per participant.|BAX 855 Safety Analysis Set.||serious adverse events|||Number
855979|NCT02210091|Secondary|Hemostatic Efficacy Rating for Bleeding Episodes Treated With BAX 855 at Resolution of Bleed|"Rating Scale for Treatment of Bleeding Episodes (BEs) (4-point ordinal scale):
Excellent: Full relief of pain and cessation of objective signs of bleeding (eg, swelling, tenderness, and decreased range of motion in the case of musculoskeletal hemorrhage) after a single infusion. No additional infusion required for the control of bleeding. Administration of further infusions to maintain hemostasis did not affect this scoring.
Good: Definite pain relief and/or improvement in signs of bleeding after a single infusion. Possibly requires more than 1 infusion for complete resolution.
Fair: Probable and/or slight relief of pain and slight improvement in signs of bleeding after single infusion. Required more than 1 infusion for complete resolution.
None: No improvement or condition worsens."|After first exposure to BAX 855 until completion of study - approx. 6 months per participant.|Participants in the Full Analysis Set who had treated bleeding episodes.||bleeding episodes|bleeding episodes||Number
855980|NCT02210091|Secondary|Consumption of BAX 855: Weight-adjusted Dose Per Bleeding Episode||During prophylaxis period of 6 months or ≥ 50 EDs, whichever occurs last|Participants in the BAX 855 Safety Analysis Set who had treated bleeding episodes.||IU/kg|bleeding episodes|Standard Deviation|Mean
855981|NCT02210091|Secondary|Consumption of BAX 855: Number of Infusions Per Bleeding Episode||During prophylaxis period of 6 months or ≥ 50 EDs, whichever occurs last|Participants in the BAX 855 Safety Analysis Set who had treated bleeding episodes.||infusions||Standard Deviation|Mean
855982|NCT02210091|Secondary|Consumption of BAX 855: Weight-adjusted Dose of Prophylactic Infusions Per Year (Annualized) Per Participant||During prophylaxis period of 6 months or ≥ 50 EDs, whichever occurs last|BAX 855 Safety Analysis Set.||IU/kg||Standard Deviation|Mean
855983|NCT02210091|Secondary|Consumption of BAX 855: Weight-adjusted Dose of Prophylactic Infusions Per Month Per Participant||During prophylaxis period of 6 months or ≥ 50 EDs, whichever occurs last|BAX 855 Safety Analysis Set.||IU/kg||Standard Deviation|Mean
855984|NCT02210091|Secondary|Consumption of BAX 855: Number of Prophylactic Infusions Per Year (Annualized) Per Participant||During prophylaxis period of 6 months or ≥ 50 EDs, whichever occurs last|BAX 855 Safety Analysis Set.||infusions per year||Standard Deviation|Mean
855985|NCT02210091|Secondary|Consumption of BAX 855: Number of Prophylactic Infusions Per Month Per Participant||During prophylaxis period of 6 months or ≥ 50 EDs, whichever occurs last|BAX 855 Safety Analysis Set.||infusions per month||Standard Deviation|Mean
855986|NCT02210091|Secondary|Annualized Bleeding Rate (ABR)|"The annualized bleeding rate (ABR) during the prophylaxis period was assessed based upon each individual bleeding episode, spontaneous or traumatic, recorded in the participant´s diary and/or recorded in the physician/nurse/study site notes.
The annualized bleeding rate was analyzed using a generalized linear model framework assuming a negative binomial distribution with a logarithmic link function and presence or absence of target joints and age cohort as covariates and duration of the observation period in years as offset. Point estimates for the mean and 95% confidence intervals are presented."|During prophylaxis period of 6 months or ≥ 50 EDs, whichever occurs last|Full Analysis Set: All participants who received at least 1 dose of BAX 855 in either PK or prophylaxis part of study||bleeding episodes per year||95% Confidence Interval|Mean
855987|NCT02210091|Primary|Number of Participants With Inhibitory Antibodies to Factor VIII (FVIII)|Inhibitory antibodies to FVIII were measured using the Nijmegen modification of the Bethesda assay. Incidence of an FVIII inhibitory antibody was defined as an inhibitor level ≥0.6 Bethesda units [BU].|After first exposure to BAX 855 until completion of study - approx. 6 months per participant.|Participants in the BAX 855 Safety Analysis Set who developed an inhibitor at any time plus participants who did not develop an inhibitor, had 50 or more exposure days (EDs) to BAX 855 and had FVIII Inhibitory test results after 50 EDs.||participants|||Number
856059|NCT01942590|Secondary|Change in Forced Vital Capacity (FVC) in Pulmonary Function Testing|Forced vital capacity (FVC) is the total amount of air exhaled during the lung function test.|Baseline, Week 52|participants who completed FVC testing||change in FVC measured as % expected||Standard Deviation|Mean
856006|NCT02071420|Primary|Change in Occupational Physical Activity From Baseline to 16 Weeks|Occupational physical activity (primary outcome) will be measured objectively with the GENEActiv physical activity monitor. The monitor will be worn on the right ankle and will be worn for 5 working days during all non-bathing hours. The outcome measure will be change in occupational activity (average counts/work day) from baseline to 16 weeks. The measure will be calculated as follows: 16 weeks value - baseline value.|Baseline and 16 weeks|||Average counts/work day||95% Confidence Interval|Mean
856008|NCT01989156|Primary|Levels of Carboxyhemoglobin (COHb)|Carboxyhemoglobin (COHb) is assayed from whole blood. Expressed as % of saturation of hemoglobin. Blood measurements performed in the evening of Day 5, for the smokers of all arms (mTHS, mCC and SA). Geometric Least Squares means are provided as descriptive statistics.|5 days|The analysis was performed on the Per Protocol set (PP) which included all randomized subjects who had no major protocol deviation impacting the evaluability during the confinement period.||% of saturation of hemoglobin||95% Confidence Interval|Geometric Mean
856009|NCT01989156|Primary|Levels of Total 4-(Methylnitrosamino)-1-(3- Pyridyl)-1-butanol (Total NNAL)|Concentrations measured in urine, adjusted for creatinine, at Day 90 for the smokers of all arms (mTHS, mCC and SA). Geometric Least Squares means are provided as descriptive statistics.|90 days|The analysis was performed on the Per Protocol set (PP) which included all randomized subjects who had no major protocol deviation impacting the evaluability during the confinement period.||pg/mg creat||95% Confidence Interval|Geometric Mean
856010|NCT01989156|Primary|Concentration of S-phenylmercapturic Acid (S-PMA)|Concentrations measured in urine, adjusted for creatinine, at Day 5 for the smokers of all arms (mTHS, mCC and SA). Geometric Least Squares means are provided as descriptive statistics.|5 days|The analysis was performed on the Per Protocol set (PP) which included all randomized subjects who had no major protocol deviation impacting the evaluability during the confinement period.||pg/mg creat||95% Confidence Interval|Geometric Mean
856011|NCT01989156|Primary|Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA)|Concentrations measured in urine, adjusted for creatinine, at Day 5 for the smokers of all arms (mTHS, mCC and SA). Geometric Least Squares means are provided as descriptive statistics.|5 days|The analysis was performed on the Per Protocol set (PP) which included all randomized subjects who had no major protocol deviation impacting the evaluability during the confinement period.||ng/mg creat||95% Confidence Interval|Geometric Mean
856012|NCT01989156|Primary|Concentration of Monohydroxybutenylmercapturic Acid (MHBMA)|Concentrations measured in urine, adjusted for creatinine, at Day 5 for the smokers of all arms (mTHS, mCC and SA). Geometric Least Squares means are provided as descriptive statistics.|5 days|The analysis was performed on the Per Protocol set (PP) which included all randomized subjects who had no major protocol deviation impacting the evaluability during the confinement period.||pg/mg creat||95% Confidence Interval|Geometric Mean
856013|NCT01987908|Secondary|Reduction in Sickle Cell-specific Complications||Throughout the study period (approximately 9 weeks)|Data not collected for this outcome measure. Study terminated early.|||||
856014|NCT01987908|Secondary|Analgesic Use|Analgesic use assessed with pain levels by numerical pain rating scale (NPRS) and brief pain inventory (BPI).|Throughout the study period (approximately 9 weeks)|Data not collected for this outcome measure. Study terminated early.|||||
856016|NCT01987908|Secondary|Brief Pain Inventory (BPI): Interference of Pain With Aspects of Life (General Activity) During Double-blind Treatment Period - Change From Baseline|"Participants rated the degree to which their pain interfered with various daily functions by using the BPI short form. Interference with general activity was rated on a scale from 0 (does not interfere) to 10 (completely interferes).
Baseline was defined as the most recent value obtained prior to the start of the dosing on Day 1 of the double-blind dosing period.
Category title includes number of participants with available data (n) for participants treated with study product, followed by participants treated with placebo."|At baseline, Day 7 and Day 28 during the double-blind treatment period|Participants who provided baseline data and at least one other data point for this outcome measure.||score on a scale||Standard Deviation|Mean
856017|NCT01987908|Secondary|Brief Pain Inventory (BPI): Worst Pain Level in Last 24 Hours (Post-treatment Observation Period) - Change From Baseline|"Participants rated the severity of their pain by using the BPI short form. Pain was rated on a scale from 0 (no pain) to 10 (pain as bad as you can imagine). A negative mean change denotes a pain decrease. A positive mean change denotes an increase in pain.
Baseline was defined as the most recent value obtained prior to the start of the dosing on Day 1 of the double-blind dosing period."|At baseline and Day 49 during the post-treatment observation period|Participants who provided baseline data and at least one other data point for this outcome measure.||score on a scale||Standard Deviation|Mean
856018|NCT01987908|Secondary|Brief Pain Inventory (BPI): Worst Pain Level in Last 24 Hours (Double-blind Treatment Period) - Change From Baseline|"Participants rated the severity of their pain by using the BPI short form. Pain was rated on a scale from 0 (no pain) to 10 (pain as bad as you can imagine). A negative mean change denotes a pain decrease. A positive mean change denotes an increase in pain.
Baseline was defined as the most recent value obtained prior to the start of the dosing on Day 1 of the double-blind dosing period.
Category title includes number of participants with available data (n) for participants treated with study product, followed by participants treated with placebo."|At baseline, Day 7 and Day 28 during the double-blind treatment period|Participants who provided baseline data and at least one other data point for this outcome measure.||score on a scale||Standard Deviation|Mean
856019|NCT01987908|Secondary|Brief Pain Inventory (BPI): Average Pain Level in Last 24 Hours (Double-blind Treatment Period) - Change From Baseline|"Participants rated the severity of their pain by using the BPI short form. Pain was rated on a scale from 0 (no pain) to 10 (pain as bad as you can imagine). A negative mean change denotes a pain decrease. A positive mean change denotes an increase in pain.
Baseline was defined as the most recent value obtained prior to the start of the dosing on Day 1 of the double-blind dosing period.
Category title includes number of participants with available data (n) for participants treated with study product, followed by participants treated with placebo."|At baseline, Day 7 and Day 28 during the double-blind treatment period|Participants who provided baseline data and at least one other data point for this outcome measure.||score on a scale||Standard Deviation|Mean
856020|NCT01987908|Secondary|Numerical Pain Rating Scale (NPRS): Worst Pain (Weekly Average) in the Post-treatment Observation Period - Change From Last Day of Double-blind Treatment Period (Day 28) - AUC|Participants assessed their pain levels by using the 0-10 Numeric Rating Scale: 0 = No pain 1-3 = Mild pain (nagging, annoying, interfering little with activities of daily living [ADLs]) 4-6 = Moderate pain (interferes significantly with ADLs) 7-10 = Severe pain (disabling; unable to perform ADLs A negative mean change denotes a pain decrease. A positive mean change denotes an increase in pain. Baseline was defined as the most recent value obtained on the last day of the double-blind dosing period (Day 28). Area under the curve (AUC) was computed using change from baseline (Day 28) in weekly average values at Day 35, Day 42 and Day 49.|Participants assessed and recorded their pain level daily. Weekly averages were calculated for the Day 35, Day 42 and Day 49 assessments|||NPRS score*week||Standard Deviation|Mean
856021|NCT01987908|Secondary|Numerical Pain Rating Scale (NPRS): Worst Pain (Weekly Average) in the Post-treatment Observation Period - Change From Last Day of Double-blind Treatment Period (Day 28)|"Participants assessed their pain levels by using the 0-10 Numeric Rating Scale: 0 = No pain 1-3 = Mild pain (nagging, annoying, interfering little with activities of daily living [ADLs]) 4-6 = Moderate pain (interferes significantly with ADLs) 7-10 = Severe pain (disabling; unable to perform ADLs A negative mean change denotes a pain decrease. A positive mean change denotes an increase in pain. Baseline was defined as the most recent value obtained on the last day of the double-blind dosing period (Day 28).
Category title includes number of participants with available data (n) for participants treated with study product, followed by participants treated with placebo."|Participants assessed and recorded their pain level daily. Weekly averages were calculated for the Day 35, Day 42 and Day 49 assessments|||score on a scale||Standard Deviation|Mean
856022|NCT01987908|Secondary|Numerical Pain Rating Scale (NPRS): Worst Pain (Weekly Average) in the Post-treatment Observation Period - AUC|Participants assessed their pain levels by using the 0-10 Numeric Rating Scale: 0 = No pain 1-3 = Mild pain (nagging, annoying, interfering little with activities of daily living [ADLs]) 4-6 = Moderate pain (interferes significantly with ADLs) 7-10 = Severe pain (disabling; unable to perform ADLs A negative mean change denotes a pain decrease. A positive mean change denotes an increase in pain. Baseline was defined as the average of all measures taken from screening through the period prior to start of dosing on Day 1. Area under the curve (AUC) was computed using change from baseline in weekly average values at Day 7, Day 14, Day 21, Day 28, Day 35, Day 42 and Day 49.|Participants assessed and recorded their pain level daily. Weekly averages were calculated for the Day 35, Day 42 and Day 49 assessments|||NPRS score*week||Standard Deviation|Mean
856023|NCT01987908|Secondary|Numerical Pain Rating Scale (NPRS): Worst Pain (Weekly Average) in the Post-treatment Observation Period - Change From Baseline|"Participants assessed their pain levels by using the 0-10 Numeric Rating Scale: 0 = No pain 1-3 = Mild pain (nagging, annoying, interfering little with activities of daily living [ADLs]) 4-6 = Moderate pain (interferes significantly with ADLs) 7-10 = Severe pain (disabling; unable to perform ADLs A negative mean change denotes a pain decrease. A positive mean change denotes an increase in pain. Baseline was defined as the average of all measures taken from screening through the period prior to start of dosing on Day 1.
Category title includes number of participants with available data (n) for participants treated with study product, followed by participants treated with placebo."|Participants assessed and recorded their pain level daily. Weekly averages were calculated for the Day 35, Day 42 and Day 49 assessments|||score on a scale||Standard Deviation|Mean
856024|NCT01987908|Secondary|Numerical Pain Rating Scale (NPRS): Worst Pain (Weekly Average) in the Double-blind Treatment Period - AUC|Participants assessed their pain levels by using the 0-10 Numeric Rating Scale: 0 = No pain 1-3 = Mild pain (nagging, annoying, interfering little with activities of daily living [ADLs]) 4-6 = Moderate pain (interferes significantly with ADLs) 7-10 = Severe pain (disabling; unable to perform ADLs A negative mean change denotes a pain decrease. A positive mean change denotes an increase in pain. Baseline was defined as the average of all measures taken from screening through the period prior to start of dosing on Day 1. Area under the curve (AUC) was computed using change from baseline in weekly average values at Day 7, Day 14, Day 21. and Day 28.|Participants assessed and recorded their pain level daily. Weekly averages were calculated for the Day 7, Day 14, Day 21, and Day 28 assessments|||NPRS score*week||Standard Deviation|Mean
856025|NCT01987908|Secondary|Numerical Pain Rating Scale (NPRS): Worst Pain (Weekly Average) in the Double-blind Treatment Period - Change From Baseline|"Participants assessed their pain levels by using the 0-10 Numeric Rating Scale: 0 = No pain 1-3 = Mild pain (nagging, annoying, interfering little with activities of daily living [ADLs]) 4-6 = Moderate pain (interferes significantly with ADLs) 7-10 = Severe pain (disabling; unable to perform ADLs A negative mean change denotes a pain decrease. A positive mean change denotes an increase in pain. Baseline was defined as the average of all measures taken from screening through the period prior to start of dosing on Day 1.
Category title includes number of participants with available data (n) for participants treated with study product, followed by participants treated with placebo."|Participants assessed and recorded their pain level daily. Weekly averages were calculated for the Day 7, Day 14, Day 21, and Day 28 assessments|||score on a scale||Standard Deviation|Mean
856026|NCT01987908|Secondary|Patients´ Global Impression of Change (PGIC) During the Post-treatment Observation Period - Change From Last Day of Double-blind Treatment Period|"Participants assessed the change in activity limitations, symptoms, emotions, and overall quality of life by using the 1- to 7-point PGIC scale. The question and scale was as follows: Since beginning treatment at this clinic, how would you describe the change in your sickle cell condition? Please circle the number that matches your overall judgment. -3 - much worse -2 - moderately worse -1 - minimally worse 0 - no change +1 - minimally improved +2 - moderately improved +3 - much improved.
Baseline was defined as the most recent value obtained on the last day of the double-blind treatment period.
Categories contain Category title includes number of participants with available data (n) for participants treated with study product, followed by participants treated with placebo."|At baseline and once weekly on Days 35, 42, and 49 during the post-treatment observation period|||score on a scale||Standard Deviation|Mean
856027|NCT01987908|Secondary|Patients´ Global Impression of Change (PGIC) During the Post-treatment Observation Period - Change From Baseline|"Participants assessed the change in activity limitations, symptoms, emotions, and overall quality of life by using the 1- to 7-point PGIC scale. The question and scale was as follows: Since beginning treatment at this clinic, how would you describe the change in your sickle cell condition? Please circle the number that matches your overall judgment. -3 - much worse -2 - moderately worse -1 - minimally worse 0 - no change +1 - minimally improved +2 - moderately improved +3 - much improved.
Baseline defined as the most recent value obtained prior to the start of dosing on Day 1 of the double-blind treatment period.
Category title includes number of participants with available data (n) for participants treated with study product, followed by participants treated with placebo."|At baseline and once weekly on Days 35, 42, and 49 during the post-treatment observation period|||score on a scale||Standard Deviation|Mean
856028|NCT01987908|Secondary|Patients´ Global Impression of Change (PGIC) During the Double-blind Treatment Period - Change From Baseline|"Participants assessed the change in activity limitations, symptoms, emotions, and overall quality of life by using the 1- to 7-point PGIC scale. The question and scale was as follows: Since beginning treatment at this clinic, how would you describe the change in your sickle cell condition? Please circle the number that matches your overall judgment. -3 - much worse -2 - moderately worse -1 - minimally worse 0 - no change +1 - minimally improved +2 - moderately improved +3 - much improved.
Baseline defined as the most recent value obtained prior to the start of dosing on Day 1 of the double-blind treatment period. No values available for placebo group for Day 28.
Category title includes number of participants with available data (n) for participants treated with study product, followed by participants treated with placebo."|At baseline and once weekly on Days 7, 14, 21, and 28 during the double-blind treatment period|||score on a scale||Standard Deviation|Mean
856029|NCT01987908|Secondary|Exercise Tolerance: Cardiopulmonary Exercise Test [CPET]|CPET was optional, based on capacity of participant to complete the test.|On last day of double-blind treatment period (Day 28)|Following an external review and report of CPET capabilities of the external service provider, all CPET testing was suspended and the decision made to not collect or analyze CPET data.|||||
856030|NCT01987908|Secondary|Exercise Tolerance: 6-Minute Walk Distance on Day 49 of the Post-treatment Observation Period - Change From Last Day of Double-blind Treatment Period (Day 28)|Functional exercise capacity was evaluated by using the 6-minute walk test (6MWT) which measures the distance that a subject can quickly walk on a flat, hard surface in a period of 6 minutes. Guidelines developed by the American Thoracic Society were used for conducting the test and interpreting the results.|On last day of double-blind treatment period (Day 28) and on Day 49 of the post-treatment observation period|Participants who provided baseline data and at least one other data point for this outcome measure.||meters||Standard Deviation|Mean
856031|NCT01987908|Secondary|Exercise Tolerance: 6-Minute Walk Distance on Day 49 of the Post-treatment Observation Period - Change From Baseline|"Functional exercise capacity was evaluated by using the 6-minute walk test (6MWT) which measures the distance that a subject can quickly walk on a flat, hard surface in a period of 6 minutes. Guidelines developed by the American Thoracic Society were used for conducting the test and interpreting the results.
Baseline defined as the most recent value obtained prior to the start of dosing on Day 1."|Prior to dosing at baseline and on Day 49 of the post-treatment observation period|Participants who provided baseline data and at least one other data point for this outcome measure.||meters||Standard Deviation|Mean
856060|NCT01942590|Secondary|Change in Forced Vital Capacity (FVC) in Pulmonary Function Testing|Forced vital capacity (FVC) is the total amount of air exhaled during the lung function test.|Baseline, Week 18|participants who completed FVC testing||change in FVC measured as % expected||Standard Deviation|Mean
856996|NCT02454608|Primary|Subjective Sinonasal Symptoms on Sinonasal Outcomes Test-22(SNOT-22)|Minimun Score: 0 Maximum Score: 110 A higher score indicates a worse outcome|baseline to week 8|Intention-to-treat analysis||units on a scale||Standard Error|Least Squares Mean
856032|NCT01987908|Secondary|Exercise Tolerance: 6-Minute Walk Distance During the Double-blind Treatment Period - Change From Baseline|"Functional exercise capacity was evaluated by using the 6-minute walk test (6MWT) which measures the distance that a subject can quickly walk on a flat, hard surface in a period of 6 minutes. Guidelines developed by the American Thoracic Society were used for conducting the test and interpreting the results.
Baseline defined as the most recent value obtained prior to the start of dosing on Day 1.
Category title includes number of participants with available data (n) for participants treated with study product, followed by participants treated with placebo."|Prior to, during and after the end of dosing in the double-blind treatment period, i.e., at baseline, Day 4, Day 7, Day 14 and Day 28|||meters||Standard Deviation|Mean
856033|NCT01987908|Secondary|Body Weight - Change From Baseline|"A negative change in body weight denotes a weight decrease, a positive change in body weight denotes a weight increase.
Category title includes number of participants with available data (n) for participants treated with study product, followed by participants treated with placebo."|Prior to, during and after the end of dosing in the double-blind treatment period, i.e., at baseline, Day 1, Day 4, Day 7, Day 14, Day 21 and Day 28|||kg||Standard Deviation|Mean
856034|NCT01987908|Secondary|N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) Levels- Change From Baseline|Category title includes number of participants with available data (n) for participants treated with study product.|At baseline, Day 1, Day 7, Day 14 and Day 28 during the double-blind treatment period|Participants who provided baseline data and at least one other data point for this outcome measure. Summary tables for placebo group not done as data not collected. Study terminated early.||pmol/L||Standard Deviation|Mean
856035|NCT01987908|Secondary|Serum Ferritin Levels - Change From Baseline||At baseline, Day 1 and Day 7 during the double-blind treatment period|Participants who provided baseline data and at least one other data point for this outcome measure. Summary tables for placebo group not done as data not collected. Study terminated early.||mircograms/L||Standard Deviation|Mean
856036|NCT01987908|Secondary|C Reactive Protein Levels - Change From Baseline|Category title includes number of participants with available data (n) for participants treated with study product.|At baseline, Day 1 and Day 7 during the double-blind treatment period|Participants who provided baseline data and at least one other data point for this outcome measure. Summary tables for placebo group not done as data not collected. Study terminated early.||mg/L||Standard Deviation|Mean
856037|NCT01987908|Secondary|LDH Isoform - Change From Baseline||Prior to, during and after the end of dosing in the double-blind treatment period, i.e., at baseline, Day 1, Day 7, Day 14 and Day 28|Summary tables for this outcome measure were not done as baseline data missing. Study terminated early.|||||
856038|NCT01987908|Secondary|Direct Bilirubin - Change From Baseline|Category title includes number of participants with available data (n) for participants treated with study product, followed by participants treated with placebo.|Prior to, during and after the end of dosing in the double-blind treatment period, i.e., at baseline, Day 1, Day 7, Day 14, Day 21 and Day 28|||mircomoles/L||Standard Deviation|Mean
856039|NCT01987908|Secondary|Reticulocyte Percent- Change From Baseline|Category title includes number of participants with available data (n) for participants treated with study product.|At baseline, Day 1 and Day 7 during the double-blind treatment period|Participants who provided baseline data and at least one other data point for this outcome measure. Summary tables for placebo group not done as data not collected. Study terminated early.||percent||Standard Deviation|Mean
856040|NCT01987908|Secondary|Hemoglobin Levels - Change From Baseline|"A clinical laboratory endpoint that reflects the amount of red blood cells present in the blood. Baseline defined as the most recent value obtained prior to the start of dosing on Day 1 of the double-blind treatment period.
Category title includes number of participants with available data (n) for participants treated with study product, followed by participants treated with placebo."|Prior to, during and after the end of dosing in the double-blind treatment period, i.e., at baseline, Day 1, Day 4, Day 7, Day 14, Day 21 and Day 28|||g/L||Standard Deviation|Mean
856041|NCT01987908|Secondary|Lactate Dehydrogenase (LDH) Levels - Change From Baseline|"LDH levels were measured as a biomarker for intravascular hemolysis. The results are based on the LDH Total measurement. Baseline defined as the most recent value obtained prior to the start of dosing on Day 1 of the double-blind treatment period.
Category title includes number of participants with available data (n) for participants treated with study product, followed by participants treated with placebo."|Prior to, during and after the end of dosing in the double-blind treatment period, i.e., at baseline, Day 1, Day 7, Day 14 and Day 28|||U/L||Standard Deviation|Mean
856042|NCT01987908|Secondary|Hematocrit Levels - Change From Baseline|"Baseline defined as the most recent value obtained prior to the start of dosing on Day 1 of the double-blind treatment period.
Category title includes number of participants with available data (n) for participants treated with study product, followed by participants treated with placebo."|Prior to, during and after the end of dosing in the double-blind treatment period, i.e., at baseline, Day 1, Day 7, Day 14 and Day 28|||L/L||Standard Deviation|Mean
856043|NCT01987908|Secondary|Plasma Erythropoietin (EPO) Levels - Change From Baseline|"Erythropoietin (EPO) is a hormone produced by the kidney that promotes the formation of red blood cells by the bone marrow. EPO can be detected and measured in the blood.
Baseline defined as the most recent value obtained prior to the start of dosing on Day 1 of the double-blind treatment period.
Category title includes number of participants with available data (n) for participants treated with study product, followed by participants treated with placebo."|At baseline and Day 28 during the double-blind treatment period|Participants who provided baseline data and at least one other data point for this outcome measure.||U/L||Standard Deviation|Mean
856044|NCT01987908|Secondary|Oxygen Binding p50/p20 Value - Change From Baseline|"A measure of the ability of hemoglobin to bind oxygen. The p50 is the oxygen level at which 50% of the hemoglobin contains oxygen. The p20 is the oxygen level at which 20% of the hemoglobin contains oxygen. Baseline is defined as the most recent value obtained prior to start of dosing on Day 1 of the double-blind treatment period.
Category title includes number of participants with available data (n) for participants treated with study product, followed by participants treated with placebo."|During the double-blind treatment period at baseline, Day 1, Day 4 and Day 7|||ratio||Standard Deviation|Mean
856061|NCT01942590|Secondary|Change in 6 Minute Walk Test|Assess exercise tolerance in study patients; test administered by physical therapist. Subjects were asked to walk for 6 minutes, unassisted. The distance walked was recorded in meters.|Baseline, week 52|Participants who completed 6 minute walk test||meters||Standard Deviation|Mean
856045|NCT01987908|Secondary|Resting Oxygen Saturation as Measured by Oximetry (SpO2) - Change From Baseline|"A measure of the amount of oxygen in the blood. Oxygen saturation was determined by pulse oximetry. A pulse oximeter was placed over a nail polish-free finger nail to determine peripheral oxygen saturation (SpO2).
Baseline was defined as the most recent value obtained prior to the start of dosing on Day 1 of the double-blind treatment period. A mean change from baseline >0 indicates an increase in oxygen saturation, a mean change <0 indicates a decrease in oxygen saturation.
Category title includes number of participants with available data (n) for participants treated with study product, followed by participants treated with placebo."|Prior to, during and after the end of dosing in the double-blind treatment period, i.e., at baseline, Day 4, Day 7, Day 14 and Day 28|||percent saturation||Standard Deviation|Mean
856046|NCT01987908|Primary|PK: - Plasma AUC, Cmax, Tmax, and T1/2 of Aes-103 and Its Metabolite, HMFA - RBC Hemolysate AUC (0-8h), Cmax, Tmax, and T1/2 of Aes-103 - Percentage of Hemoglobin Bound to Aes-103|"Pharmacokinetic endpoints in the study protocol were as follows:-
Plasma Area under curve (AUC), Maximum plasma concentration (Cmax), time at which Cmax observed (Tmax), and terminal half-life (T1/2) of Aes-103 and its metabolite, 5-hydroxymethyl-2-furoic acid (HMFA)
red blood cell (RBC) hemolysate Area under curve between 0 and 8 hours (AUC [0-8h]), Cmax, Tmax, and T1/2 of Aes-103
Percentage of hemoglobin bound to Aes-103"|PK blood samples were to be taken within 10 minutes before dosing and 0.5, 1, 2, 4, and 6 hours after the first dose of study product on Days 1 and 7 and at the same time points on Day 28 (or early termination)|PK data were not determined as the assay collection method was found to be faulty rendering all samples unevaluable.|||||
856047|NCT01987908|Primary|Number of Clinically Significant Observations of Vital Signs, 12-lead ECGs, Clinical Laboratory Assessments, and Physical and Neurological Examinations|Vital signs, 12-lead ECGs, clinical laboratory assessments, and physical and neurological examinations that were deemed clinically significant by the investigator in agreement with the sponsor study director.|Throughout the study period (approximately 9 weeks)|safety analysis dataset||clinically significant observations|||Number
856048|NCT01987908|Primary|Number of Participants With Sickle-Cell Disease-related Symptoms||Placebo lead-in period of 14 days (Day -14 to Day -1), double-blind treatment period of 28 days (Day 1 to Day 28) and post-treatment observation period of 21 days (Day 29 to Day 49)|||participants|||Number
856049|NCT01987908|Primary|Number of Participants With Adverse Events, Including Sickle-cell Specific Symptoms, During the Post-treatment Observation Period|Number of participants with adverse events (AEs) reported during the post-treatment observation period. AEs included clinically-significant changes in vital signs, ECG, clinical laboratory assessments, physical and neurological examinations. Sickle cell-specific symptoms included the development of new skin ulcers, hospitalization or ambulatory acute care, intravenous analgesics visit for pain episodes (i.e., sickle-cell disease related pain), acute chest syndrome, priapism, and stroke.|Post-treatment observation period of 21 days (Day 29 to Day 49)|||participants|||Number
856050|NCT01987908|Primary|Number of Participants With Adverse Events, Including Sickle-cell Specific Symptoms, During the Placebo lead-in Period|Number of participants with adverse events (AEs) reported during the placebo lead-in period. AEs included clinically-significant changes in vital signs, ECG, clinical laboratory assessments, physical and neurological examinations. Sickle cell-specific symptoms included the development of new skin ulcers, hospitalization or ambulatory acute care, intravenous analgesics visit for pain episodes (i.e., sickle-cell disease related pain), acute chest syndrome, priapism, and stroke.|Placebo lead-in period of 14 days (Day -14 to Day -1)|||participants|||Number
856051|NCT01987908|Primary|Number of Participants With Adverse Events, Including Sickle Cell-specific Symptoms, During the Double-blind Treatment Period|Number of participants with adverse events (AEs) reported during the double-blind treatment period. AEs included clinically-significant changes in vital signs, ECG, clinical laboratory assessments, physical and neurological examinations. Sickle cell-specific symptoms included the development of new skin ulcers, hospitalization or ambulatory acute care, intravenous analgesics visit for pain episodes (i.e., sickle-cell disease related pain), acute chest syndrome, priapism, and stroke.|Double-blind treatment period of 28 days (Day 1 to Day 28)|||participants|||Number
856052|NCT01942590|Secondary|Maximum Expiratory Pressure (MEP)|MEP reflects the strength of the abdominal muscles and other expiratory muscles.|Baseline, Week 18, and Week 52|Participants who completed the MEP testing||percentage of MEP||Standard Deviation|Mean
856053|NCT01942590|Secondary|Predicted Maximum Inspiration Pressure (MIP)|MIP is a measurement of inspiratory muscle weakness, including weakness of the diaphragm. MIP is decreased in Pompe disease and reflects weakness of respiratory muscles.|Baseline, Week 18, and Week 52|Participants who completed the MIP testing||percentage of MIP||Standard Deviation|Mean
856054|NCT01942590|Secondary|Late-Life Function and Disability Instrument (LLFDI)|The Late-Life Function & Disability Instrument (Late-Life FDI) is an evaluative outcome instrument for community-dwelling older adults. Highest score 240 = normal function and no disability, lowest score 0 = low levels of frequency of participating in life tasks.|Baseline, Week 18, Week 52|Participants who completed LLFDI at the visit. Data was not collected from any participants in the placebo group.||units on a scale||Standard Deviation|Mean
856055|NCT01942590|Secondary|Quick Motor Function Test (QMFT)|The QMFT is a criterion referenced assessment designed to measure functional status and change in gross motor function over time and, in particular, to measure clinically relevant change. Consists of 16 motor function tests. Lowest score 0 = unable to perform motor function tests, highest score 64 = normal muscle function.|Baseline, Week 18, and Week 52|||units on a scale||Standard Deviation|Mean
856056|NCT01942590|Secondary|GSGC (Gait, Stairs, Gowers, Arising From a Chair.)|The GSGC is a criterion referenced assessment designed to measure functional status and change in gross motor function over time and, in particular, to measure clinically relevant change. Consists of 4 components: Gait, Climbing Stairs, Gower’s Manuever, Arising From a Chair. Lowest score 4 = normal muscle function, highest score 27 = unable to perform motor function tests.|Baseline, Week 18, and Week 52|participants who completed GSGC testing||units on a scale||Standard Deviation|Mean
856057|NCT01942590|Secondary|Change in Urinary Glc4 Biomarker||Baseline, Week 52|participants who completed urinary Glc4 biomarker collection||mmol/mol CN||Standard Deviation|Mean
856058|NCT01942590|Secondary|Change in Urinary Glc4 Biomarker|The Glc4 biomarker is measured in urine and correlates with muscle glycogen content. It is a noninvasive measurement that serves as a biomarker for Pompe disease.|Baseline, Week 18|||mmol/mol CN||Standard Deviation|Mean
856111|NCT01790659|Secondary|Percentage of Subjects With All Lesions Cured|• Percentage of subjects with all lesions cured, defined as: Final clinical cure as defined in primary objective (which is based solely on the index lesion); AND, Cure of all other lesions by nominal Day 168 (100% re-epithelialization of all ulcerated lesions and resolution of all other types of lesions)|168 ± 14 days|||percentage of participants|||Number
856093|NCT01828983|Primary|Spouse Self Report of Depression|Patient Health Questionnaire - Depression (PHQ)-9 measured at baseline, 6 and 12 months. Scores range from 0-27 with higher scores indicating more depressive symptoms.|Baseline, 6 months|Participants with data at baseline and 6 months||units on a scale||Standard Error|Mean
856094|NCT01828983|Primary|Spouse Self Report of Anxiety|Generalized Anxiety Disorder (GAD-7) measured at baseline, 6 and 12 months. Scores range from 0 to 21; higher scores equal more anxiety.|baseline, and 6 months|Participants who had data at baseline and 6 months||units on a scale||Standard Error|Mean
856095|NCT01828983|Primary|Spouse Self-report of Resilience|Connor-Davidson Resilience Scale (CD-RISC) measured at baseline, 6 and 12 months. Scores range from 0-100. Higher scores equal greater resilience.|Baseline, 6 months|Participants who had data at baseline and 6 months||units on a scale||Standard Error|Mean
856096|NCT01800162|Secondary|Future Fertility|Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.|6 weeks||||||
856097|NCT01800162|Secondary|Acceptability|Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.|6 weeks||||||
856098|NCT01800162|Secondary|Patients' Preferences|Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.|6 weeks||||||
856099|NCT01800162|Secondary|Time to Resolution|Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.|6 weeks||||||
856100|NCT01800162|Secondary|Number of Visits|Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.|6 weeks||||||
856101|NCT01800162|Secondary|Number of Procedures (Lab Tests, Ultrasounds)|Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.|6 weeks||||||
856102|NCT01800162|Secondary|Treatment Complications and Adverse Events|Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.|42 days after the last dose of study medication||||||
856103|NCT01800162|Secondary|Quantification of Re-interventions Needed to Manage a Woman With a PPUL|"Outcomes include:
number of interventions beyond that of intended initial strategy in each group
additional number of MTX injections
additional surgical procedures
uterine evacuation (or dilation and curettage)
laparoscopy
laparotomy"|6 weeks||||||
856104|NCT01800162|Secondary|Number of Ruptured Ectopic Pregnancies in Each Group|Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.|6 weeks||||||
856105|NCT01800162|Primary|Frequency of Clinical Resolution for the 3 Different Management Arms for a Persisting PUL.|Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.|Outcome will be assessed within 6 weeks of randomization|Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.|||||
856106|NCT01790659|Secondary|Median Time to Initial Clinical Cure for Index Lesions|Median time to initial clinical cure for index lesions (100% re-epithelialization of the index lesion)|When 100% re-epithelialization of the index lesion is observed at any visit Study Days (20, 35 ± 2 days, 49 ± 4 days, 63 ± 7 days, 100 ± 14 days, and 168 ± 14 days|Evaluable subjects||Days||95% Confidence Interval|Median
856107|NCT01790659|Secondary|Number of All Lesions Meeting Criteria for Clinical Cure|Number of all lesions meeting criteria for clinical cure at each visit - evaluable subjects. Cure is defined as 100% re-epithelialization of an ulcerated lesion|baseline (before the start of treatment), and on Study Days 20, 35 ± 2 days, 49 ± 4 days, 63 ± 7 days, 100 ± 14 days, and 168 ± 14 days|Evaluable subjects||Lesions|||Number
856108|NCT01790659|Secondary|Area of Ulceration (mm^2) All Treated Lesions at Each Measurement Time Point|Area of ulceration (mm^2) of all treated lesions from baseline (before the start of treatment), and on Study Days 20, 35 ± 2 days, 49 ± 4 days, 63 ± 7 days, 100 ± 14 days, and 168 ± 14 days for mITT subjects. Data presented is as presented in the Final Clinical Study Repot; any inconsistencies can't be changed.|baseline (before the start of treatment), and on Study Days 20, 35 ± 2 days, 49 ± 4 days, 63 ± 7 days, 100 ± 14 days, and 168 ± 14 days|All lesions for mITT Subjects||mm^2|Number of lesions|Standard Deviation|Mean
856109|NCT01790659|Secondary|Area of Ulceration (mm^2) of the Index Lesion at Each Measurement Time Point|Area of ulceration (mm^2) of the index lesion at each measurement time point for mITT subjects|baseline (before the start of treatment), and on Study Days 20, 35 ± 2 days, 49 ± 4 days, 63 ± 7 days, 100 ± 14 days, and 168 ± 14 days|mITT subjects||mm^2||Standard Deviation|Mean
856110|NCT01790659|Secondary|Percentage of All Lesions Cured at Day 168 (Ignores Per Subject Cure Rate)|Percentage of all lesions meeting criteria for clinical cure during the study at 168 day mark for mITT subjects|Day 168|Cure rates of all lesions over time without regard to subject for mITT subjects||percentage of lesions|||Number
856112|NCT01790659|Primary|Final Clinical Cure Change From Baseline|"The primary efficacy endpoint is number of subjects with final clinical cure. Final clinical cure is defined as follows:
Subject has initial clinical cure (100% re-epithelialization of index lesion by nominal Day 63); OR,
Subject has initial clinical improvement (> 50% re-epithelialization of index lesion by nominal Day 63) followed by 100% re-epithelialization of the index lesion on or before nominal Day 100; AND,
Subject has no relapse of index lesion."|baseline (before the start of treatment), and on Study Days 20, 35 ± 2 days, 49 ± 4 days, 63 ± 7 days, 100 ± 14 days, and 168 ± 14 days|||Participants|||Count of Participants
856122|NCT01757405|Secondary|Percentage of Participants With Inhibitor Development to FVII|Development of rFVII inhibitors or FVIIa binding antibodies during the study.|6 months (throughout study period)|Safety Analysis Dataset||percent of participants|||Number
856123|NCT01757405|Secondary|Safety and Tolerability of Treatment Regimens by Clinical Assessment of Adverse Events (AEs)|"Safety was determined by the number of AEs (both serious AEs [SAEs] and non-serious AEs [nsAE]).
Tolerability was determined by the number of AEs related to rFVIIa BI (both SAEs and nsAEs) as determined by causality assessment of the AEs by the investigator. An AE was deemed Related if the investigator judges the AE to be possibly related or probably related to rFVIIa BI.
The percentage of AEs were presented by seriousness (SAE, nsAE), severity (Mild, Moderate or Severe) and causality (Related or Not Related [to rFVIIa BI])."|6 months (throughout study period)|Safety Analysis Dataset||percent of AEs|adverse events||Number
856124|NCT01757405|Secondary|Safety and Tolerability of Treatment Regimens by Clinical Assessment of Percentage of Participants With Adverse Events (AEs)|"Safety was determined by the number of AEs (both serious AEs [SAEs] and non-serious AEs [nsAE]).
Tolerability was determined by the number of AEs related to rFVIIa BI (both SAEs and nsAEs) as determined by causality assessment of the AEs by the investigator. An AE was deemed Related if the investigator judged the AE to be possibly related or probably related to rFVIIa BI.
The percentage of participants with AEs were presented by seriousness (SAE, nsAE), severity (Mild, Moderate or Severe) and causality (Related or Not Related to rFVIIa BI)."|6 months (throughout study period)|Safety Analysis Dataset||percent of participants with AEs|||Number
856125|NCT01757405|Secondary|Percentage of Clinical Responders (Sustained Bleeding Control) for All Acute Bleeding Episodes|Clinical responders defined as sustained bleeding control, (no additional hemostatic medication including rFVIIa BI required between 12 and 24 hours after first infusion of the successfully treated bleeding episode).|24 hours post infusion|Full Analysis Dataset||percent of bleeding episodes|Bleeding Episodes|95% Confidence Interval|Number
856126|NCT01757405|Secondary|Treatment Response for Each Bleeding Episode|"Participants rated the treatment of each bleeding episode. If treatment occurred under direct supervision of treating physician, the physician rated the response.
Ratings based on a 4 point scale; EXCELLENT - full relief of pain and cessation of objective signs of bleeding (swelling, tenderness, decrease in range of motion [for muscle bleeds]) within 9 hours of treatment initiation. No additional infusion required to control bleeding, other than prescribed dosing regimen.
GOOD - Substantial relief of pain and/or cessation of objective signs of bleeding within 9 hours of treatment initiation. No additional infusion required to control bleeding, other than prescribed dosing regimen.
MODERATE - slight relief of pain and slight improvement of signs of bleeding within 9 hours of treatment initiation. Requires additional infusion beyond treatment regimen.
NONE - No improvement or condition worsens. SUCCESSFUL = EXCELLENT or GOOD."|within 24 hours of infusion|Full Analysis Dataset||percent of bleeding episodes|Bleeding Episodes|95% Confidence Interval|Number
856127|NCT01757405|Primary|"Percentage of Bleeding Episode With Treatment Success"|No additional hemostatic product required within 12 hours of first dose other than the prescribed dosing regimen.|within 12 hours of first dose|Full Analysis Dataset||percent of bleeding episodes|Bleeding Episodes|95% Confidence Interval|Number
856128|NCT01749501|Secondary|Timing of Entire Procedure (Stopwatch)and Recording Number of Attempts to Successful Intubation Recorded.||24 hours after intubation procedure|||minutes||Standard Deviation|Mean
856129|NCT01749501|Primary|Present the Percentage of Participants With an Excellent Ease of Intubation Rating|"percentage of participants with an excellent ease of intubation rating based on Scale of 1-4 (1 Being Excellent, 4 Being Poor),"|24 hours after intubation period|||% reported as excellent|||Number
856155|NCT01736579|Secondary|Volumetric MRI|Volumetric MRI measurements were obtained to assess rate of whole brain atrophy and ventricular enlargement. Additional volumetric measurements may be analyzed when specific hypotheses and methods are defined. Additional volumetric MRI analysis may include (but may not be limited to) one or more of the following: rate of hippocampal atrophy, entorhinal cortical thickness, and/or regional cortical thinning.|6 months|This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality.|||||
856156|NCT01736579|Secondary|Time to Skilled Nursing Facility Placement|Time to skilled nursing facility placement is defined as permanent admission to a skilled nursing facility. Time will be defined as the number of months between enrollment into this clinical study and placement in a skilled nursing facility placement.|6 months|This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality.|||||
856157|NCT01736579|Secondary|Caregiver Burden Questionnaire|The Caregiver burden questionnaires is a self-administered questionnaire that has been developed to measure the emotional, physical, and social impact of caregiving on Alzheimer's Disease caregivers. A Total score is calculated from this measure by summing the responses across the items. The Total score may range from 9-45, with higher scores indicating greater burden.|6 months|This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality.|||||
856158|NCT01736579|Secondary|Healthcare Resource Utilization Questionnaire (HRUQ)|The HRUQ determines if there is a difference in healthcare utilization and health-related expenditures, most notably nursing home (ie, skilled nursing facility) admissions, when subjects are treated with study product. This assessment is performed with the primary caregiver. This assessment is descriptive and does not contain specific scores.|6 months|This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality.|||||
856159|NCT01736579|Secondary|EQ-5D Questionnaire (Proxy Version)|"EQ-5D is a participant answered questionnaire scoring 5 dimensions - mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ-5D total score ranges from 0 (worst health state) to 1 (perfect health state) and 1 reflects the best outcome.
The EQ-5D also includes a standard vertical 20 cm visual analogue scale (VAS) ranging from best imaginable health state [100] to worst imaginable health state [0].
Caregivers are asked to describe how they believe a participant would rate his/her health state that day."|6 months|This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality.|||||
856160|NCT01736579|Secondary|Logsdon Quality of Life in Alzheimer's Disease (QOL-AD)|The QOL-AD is a validated, 13-item instrument developed specifically for individuals with dementia. The assessment rates the participant’s quality of life for physical, emotional, interpersonal, and environmental domains. The QOL-AD total score ranged 13-52. Lower scores on the QOL-AD are associated with a lower quality of life.|6 months|This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality.|||||
856161|NCT01736579|Secondary|Neuropsychiatric Inventory (NPI) Score|The NPI is a validated instrument used to assess behavioral psychopathology in Alzheimer's Disease; it evaluates the frequency and severity of 12 neuropsychiatric features including delusions, hallucinations, dysphoria, anxiety, agitation/aggression, euphoria, disinhibition, irritability/lability, apathy, aberrant motor activity, sleep and night-time behavior change, and appetite and eating change. The NPI total score ranged 0-144, with higher scores indicating greater impairment.|6 months|This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality.|||||
856322|NCT01488994|Secondary|Health Resource Use: Length of Hospitalization|The length of hospitalization per participant. Number of participants contributing data (N) for this outcome measure is included in the category title in the order: pediatric participants < 6 years of age; pediatric participants 6 to <12 years of age; Full Analysis Set.|Baseline (Pharmacokinetic [PK] assessment), Week 5, Week 13 and Week 26|||Days||Full Range|Median
856162|NCT01736579|Secondary|Mini Mental State Examination (MMSE)|The MMSE is a test for cognitive dysfunction. The test provides a 30-point composite rating for spatial and temporal orientation, verbal recall, simple attention, working memory, naming, repetition, comprehension, writing and constructional abilities. The total score can range from 0 to 30 with a higher score indicating better function.|6 months|This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality.|||||
856163|NCT01736579|Secondary|Alzheimer's Disease Cooperative Study (ADCS) - Activities of Daily Living (ADL) Inventory (ADCS-ADL/ ADCS-ADL-severe)|"The ADCS-ADL scale is a validated tool to assess instrumental and basic activities of daily living based on a 23 item structured interview of the caregiver or qualified study partner.
Scores on the ADCS-ADL range from 0-78 with lower scores indicating greater impairment; hence decreases from baseline reflect potential functional deterioration."|6 months|This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality.|||||
856164|NCT01736579|Secondary|Total Score of the Cognitive Subscale of the Severe Impairment Battery (SIB)|The SIB is a 40-item psychometric assessment that is composed of simple one-step commands combined with gestures. The scoring range is from 0 to 100 with a lower score indicating greater cognitive impairment.|6 months|This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality.|||||
856165|NCT01736579|Secondary|Total Score of the Cognitive Subscale of the Alzheimer's Disease Assessment Scale (ADAS-Cog)|"The ADAS-Cog is a validated psychometric instrument that evaluates memory (word recall, word recognition), attention, reasoning (following commands), language (naming, comprehension), orientation, ideational praxis (placing letter in envelope) and constructional praxis (copying geometric designs). This test was administered by experienced raters certified by Alzheimer’s Disease Cooperative Study (ADCS) at the site.
Scores on the ADAS-Cog range from 0-70 with higher scores indicating greater impairment."|6 months|This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality.|||||
856166|NCT01736579|Primary|Number of Infusions Discontinued, Slowed or Interrupted Due to an Adverse Event (AE) or Serious Adverse Event (SAE)||6 months|||infusions|Infusions||Number
856167|NCT01736579|Primary|Number of Infusions Causally Associated With Adverse Events (AEs) and Serious Adverse Events (SAEs)||6 months|||infusions|Infusions||Number
856168|NCT01736579|Primary|Number of Infusions Temporally Associated With Adverse Events (AEs) and Serious Adverse Events (SAEs)||6 months|||infusions|Infusions||Number
856169|NCT01736579|Primary|Number and Severity of Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)||6 months|||adverse events|||Number
856170|NCT01725126|Secondary|Tmax of Metformin During the Double-blind Treatment Period of Part C|Blood samples were planned to be collected on Day -1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4 (pre-lunch), 5.5, 6, 8, 10 (pre-dinner), 11.5, 12, 14 and 24 hours post-dose. The time at which Cmax was observed was planned to be determined directly from the raw concentration-time data. The data for PK parameters of metformin during Part C was not collected due to variations in formulation and regimen.|Day -1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4 (pre-lunch), 5.5, 6, 8, 10 (pre-dinner), 11.5, 12, 14 and 24 hours post-dose|Metformin PK Population in Part C. The data for PK parameters of metformin during Part C was not collected due to variations in formulation and regimen.|||||
856171|NCT01725126|Secondary|Cmax of Metformin During the Double-blind Treatment Period of Part C|Blood samples were planned to be collected on Day -1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4 (pre-lunch), 5.5, 6, 8, 10 (pre-dinner), 11.5, 12, 14 and 24 hours post-dose. The first occurrence of the Cmax was planned to be determined directly from the raw concentration-time data. The data for PK parameters of metformin during Part C was not collected due to variations in formulation and regimen.|Day -1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4 (pre-lunch), 5.5, 6, 8, 10 (pre-dinner), 11.5, 12, 14 and 24 hours post-dose|Metformin PK Population in Part C. The data for PK parameters of metformin during Part C was not collected due to variations in formulation and regimen.|||||
856172|NCT01725126|Secondary|AUC From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC [0-t]) of Metformin During the Double-blind Treatment Period of Part C|Blood samples were planned to be collected on Day -1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4 (pre-lunch), 5.5, 6, 8, 10 (pre-dinner), 11.5, 12, 14 and 24 hours post-dose. The AUC 0-t was planned to be determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. The data for PK parameters of metformin during Part C was not collected due to variations in formulation and regimen.|Day -1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4 (pre-lunch), 5.5, 6, 8, 10 (pre-dinner), 11.5, 12, 14 and 24 hours post-dose|Metformin PK Population in Part C comprised of all participants in the All Subjects Population for whom a PK sample was obtained and analyzed for metformin. The data for PK parameters of metformin during Part C was not collected due to variations in formulation and regimen.|||||
856173|NCT01725126|Secondary|Tmax of Metformin During the Double-blind Treatment Period of Part A|Blood samples were collected on Day 1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4 (pre-lunch), 5.5, 6, 8 and 10 (pre-dinner) hours post-dose. The time at which Cmax was observed was determined directly from the raw concentration-time data.|Day 1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4, 5.5, 6, 8 and 10 hours post-dose|Metformin PK Population in Part A. Only those participants available at the specified time points were analyzed.||Hours||Full Range|Median
856174|NCT01725126|Secondary|Cmax of Metformin During the Double-blind Treatment Period of Part A|Blood samples were collected on Day 1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4 (pre-lunch), 5.5, 6, 8 and 10 (pre-dinner) hours post-dose. The first occurrence of the Cmax was determined directly from the raw concentration-time data.|Day 1 and Day 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4, 5.5, 6, 8 and 10 hours post-dose|Metformin PK Population in Part A. Only those participants available at specified time points were analyzed. The results from the descriptive summary used the PK Population. However, the results of the statistical analysis compared Day 42 to Day 1 PK only in the GSK2890457 group who were in the PK Population.||Nanograms/mL||Geometric Coefficient of Variation|Geometric Mean
856175|NCT01725126|Secondary|AUC of Metformin From Time 0 to 10 Hours Post-dose (AUC [0-10 Hour]) During the Double-blind Treatment Period of Part A|Blood samples were collected on Day 1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4 (pre-lunch), 5.5, 6, 8 and 10 (pre-dinner) hours post-dose. The AUC (0-10 hour) was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. The analysis population included Metformin PK Population in Part A comprising of all participants in All Subjects Population for whom a PK sample was obtained and analyzed for metformin.|Day 1 and Day 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4, 5.5, 6, 8 and 10 hours post-dose|Metformin PK Population in Part A. Only those participants available at specified time points were analyzed. The results from the descriptive summary used the PK Population. However, the results of the statistical analysis compared Day 42 to Day 1 PK only in the GSK2890457 group who were in the PK Population.||Hour*nanograms/mL||Geometric Coefficient of Variation|Geometric Mean
856176|NCT01725126|Secondary|Time of Occurrence of Cmax (Tmax) of Liraglutide During the Double-blind Treatment Period of Part B|Blood samples were collected on Day -1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4 (pre-lunch), 5.5, 6, 8, 10 (pre-dinner), 11.5, 12, 14 and 24 hours post-dose. The time at which Cmax was observed was determined directly from the raw concentration-time data.|Day -1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4, 5.5, 6, 8, 10, 11.5, 12, 14 and 24 hours post-dose|Liraglutide PK Population in Part B. Only those participants available at the specified time points were analyzed.||Hours||Full Range|Median
856177|NCT01725126|Secondary|Maximum Observed Concentration (Cmax) of Liraglutide During the Double-blind Treatment Period of Part B|Blood samples were collected on Day -1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4 (pre-lunch), 5.5, 6, 8, 10 (pre-dinner), 11.5, 12, 14 and 24 hours post-dose. The first occurrence of the Cmax was determined directly from the raw concentration-time data.|Day -1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4, 5.5, 6, 8, 10, 11.5, 12, 14 and 24 hours post-dose|Liraglutide PK Population in Part B. Only those participants available at the specified time points were analyzed. Results from descriptive summary used Liraglutide PK Population. However, results of statistical analysis compared Day 42 to Day -1 PK in GSK2890457+Liraglutide group who were in the Liraglutide PK Population.||Nanograms/mL||Geometric Coefficient of Variation|Geometric Mean
856178|NCT01725126|Secondary|Area Under Plasma Concentration From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC [0-t]) of Liraglutide During the Double-blind Treatment Period of Part B|Blood samples were collected on Day -1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4 (pre-lunch), 5.5, 6, 8, 10 (pre-dinner), 11.5, 12, 14 and 24 hours post dose. The AUC (0-t) was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. The analysis population included Liraglutide Pharmacokinetic (PK) Population in Part B comprising of all participants in All Subjects Population for whom a PK sample was obtained and analyzed for Liraglutide.|Day -1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4, 5.5, 6, 8, 10, 11.5, 12, 14 and 24 hours post-dose|Liraglutide Pharmacokinetic (PK) Population in Part B. Only those participants available at specified time points were analyzed. Results from descriptive summary used Liraglutide PK Population. However, results of statistical analysis compared Day 42 to Day -1 PK in GSK2890457+Liraglutide group who were in the Liraglutide PK Population.||Hour*nanograms/mL||Geometric Coefficient of Variation|Geometric Mean
856179|NCT01725126|Primary|Change From Baseline in Fasting Plasma Glucose (Safety Laboratory) Values During the Double-blind Treatment Period of Part B and C|The assessments were done at Day -1, Day 7, Day 14, Day 28, Day 42 and Follow-up Visit. Baseline was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline (Day -1) values from the post-Baseline (Day 7, 14, 28, 42 and Follow-up visit) values.|Baseline (Day -1) up to Follow-up (Day 56)|PD Population. Only those participants available at the specified time points were analyzed.||mmol/L||Standard Deviation|Mean
856180|NCT01725126|Primary|Change From Baseline in Matsuda Index During the Double Blind-treatment Period of Part B and C|The matsuda index was calculated from the Day -1 and Day 42 glucose and insulin results as 10,000 divided by (fasting plasma glucose x fasting plasma insulin x mean glucose at 0-2 hour post-dose x mean insulin at 0-2 hour post dose)^1/2, where glucose was measured in mmol/L and insulin in pmol/L. Baseline was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline (Day -1) values from the post-Baseline value (Day 42). Data for Part C of the study was not collected because fasting glucose and insulin were not available at the specified time points.|Baseline (Day -1) and Day 42|PD Population. Only those participants available at the specified time points were analyzed. Data for Part C of the study was not collected because fasting glucose and insulin were not available at the specified time points.||Deciliter*mL/mg*mU||Standard Deviation|Mean
856181|NCT01725126|Primary|Change From Baseline in Homeostasis Model of Assessment–Insulin Resistance (HOMA-IR]) During the Double-blind Treatment Period of Part B and C|HOMA-IR was calculated from the Day -1 and Day 42 fasting glucose and insulin values using dataset generated from the HOMA-2 model. It contained the estimates for HOMA-% insulin sensitivity (S) for pairs of fasting glucose and fasting insulin values. Study data was merged with the HOMA dataset by glucose and insulin. HOMA-IR was calculated as 100/HOMA-%S. HOMA-IR was not determined for any values outside the ranges of plasma glucose 3.5 to 25.0 mmol/L (63 – 450 mg/dL) and plasma insulin 20 to 400 pmol/L. Baseline was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline (Day -1) values from the post-Baseline value (Day 42). Data for Part C of the study was not collected because fasting glucose and insulin were not available at the specified time points.|Baseline (Day -1) and Day 42|PD Population. Only those participants available at the specified time points were analyzed. Data for Part C of the study was not collected because fasting glucose and insulin were not available at the specified time points.||mU*mmol/L^2||Standard Deviation|Mean
856182|NCT01725126|Primary|Change From Baseline in Glycated Hemoglobin (HbA1c) During the Double-blind Treatment Period of Part B and C|Baseline was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline (Day -1) values from the post-Baseline value (Day 42). Adjusted mean is reported as LS mean.|Baseline (Day -1) and Day 42|PD Population. Only those participants available at the specified time points were analyzed.||Percent of TL hemoglobin||Standard Error|Least Squares Mean
856183|NCT01725126|Primary|Change From Baseline in Fasting Insulin and Weighted Mean Insulin AUC (0-4 Hour) and AUC (0-24 Hour) During the Double-blind Treatment Period of Part B and C|Two fasting samples 5 minutes apart were taken for insulin. Baseline insulin level was the average of the 2 fasting samples. For insulin weighted mean AUC (0-4 hour) and weighted mean AUC (0-24 hour) was calculated for Baseline (Day -1) and end of treatment (Day 42). AUC was calculated using the linear trapezoid method that is the sum of the areas between each chronological pair of assessments at the time points (at Day -1 and Day 42). The weighted mean was then calculated by dividing the AUC by the length of the time interval over which it was calculated. Baseline was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline (Day -1) values from the post-Baseline value (Day 42). Data is reported for weighted mean insulin AUC (0-4 hour) post-breakfast and AUC (0-24 hour) post-breakfast.|Baseline (Day -1) and Day 42|PD Population. Only those participants available at the specified time points were analyzed.||pmol/L||Standard Deviation|Mean
856184|NCT01725126|Primary|Change From Baseline in Fasting Glucose During the Double-blind Treatment Period of Part B and C|Baseline was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline (Day -1) values from the post-Baseline value (Day 42). Adjusted mean is reported as LS mean.|Baseline (Day -1) and Day 42 of Part B and C|PD Population. Only those participants available at the specified time points were analyzed.||mmol/L||Standard Error|Least Squares Mean
856185|NCT01725126|Primary|Change From Baseline in Weighted Mean Glucose Area Under the Curves From Time 0 to 24 Hours (AUC [0-24 Hours]) During the Double-blind Treatment Period of Part B and C|AUC was calculated using the linear trapezoid method that is the sum of the areas between each chronological pair of assessments at the time points (at Day -1 and Day 42). The weighted mean was then calculated by dividing the AUC by the length of the time interval over which it was calculated. Baseline was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline (Day -1) values from the post-Baseline value (Day 42). Data is reported for weighted mean glucose AUC (0-4 hour) post-breakfast and AUC (0-24 hour) post-breakfast. Adjusted mean is reported as least square (LS) mean.|Baseline (Day -1) and Day 42|PD Population. Only those participants available at the specified time points were analyzed.||mmol/L||Standard Error|Least Squares Mean
856186|NCT01725126|Primary|Percent Change From Baseline in In-clinic Body Weight During the Double-blind Treatment Period of Part B and C|During the assessment of body weight in the unit, the participant wore lightweight indoor clothing and removed shoes. The assessments were done pre-dose at Day -1, Day 1, Day 7, Day 14, Day 28, Day 42 and Day 43. Baseline value was defined as the average of Day -1 and Day 1 values. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. Percent change was calculated by multiplying the change from Baseline value with 100. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing. Day 42 value was the average of Day 42 and Day 43 values.|Baseline (Day -1 and Day 1) up to Day 42|PD Population. Only those participants available at the specified time points were analyzed.||Percent change||Standard Deviation|Mean
856187|NCT01725126|Primary|Change From Baseline in In-clinic Body Weight During the Double-blind Treatment Period of Part B and C|During the assessment of body weight in the unit, the participant wore lightweight indoor clothing and removed shoes. The assessments were done pre-dose at Day -1, Day 1, Day 7, Day 14, Day 28, Day 42 and Day 43. Baseline value was defined as the average of Day -1 and Day 1 values. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing. Day 42 value was the average of Day 42 and Day 43 values.|Baseline (Day -1 and Day 1) up to Day 42|Pharmacodynamic (PD) Population comprised of all participants in the All Subjects Population who had Baseline and at least one post-Baseline assessment of the endpoint. Only those participants available at the specified time points were analyzed.||Kilograms (kg)||Standard Deviation|Mean
856188|NCT01725126|Primary|Change From Baseline in the Overall GSRS Score During the Double-blind Treatment Period of Part B and C|The impact of GI symptoms on health-related quality of life was assessed using the GSRS. The GSRS is a 15-item related to abdominal pain, reflux, indigestion, diarrhea and constipation syndromes, self-administered questionnaire that assesses the impact of gastrointestinal symptoms during the past week on a scale from 1 (no discomfort at all) to 7 (very severe discomfort). Overall GSRS was the mean of items 1 to 15. Possible overall scores range from 1 to 7, with lower scores indicating a better quality of life with respect to GI symptoms and higher scores indicating a lower quality of life with respect to GI symptoms. Baseline was defined as the assessment done on Day -2. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, 14, 28 and 41) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day -2) up to Day 41|All Subjects Population. Only those participants available at the specified time points were analyzed.||Scores on scale||Standard Deviation|Mean
856189|NCT01725126|Primary|Change From Baseline in the Overall Gastrointestinal (GI) Symptoms Rating Scale (GSRS) Score During the Double-blind Treatment Period of Part A|The impact of GI symptoms on health-related quality of life was assessed using the GSRS. The GSRS is a 15-item related to abdominal pain, reflux, indigestion, diarrhea and constipation syndromes, self-administered questionnaire that assesses the impact of gastrointestinal symptoms during the past week on a scale from 1 (no discomfort at all) to 7 (very severe discomfort). Overall GSRS was the mean of items 1 to 15. Possible overall scores range from 1 to 7, with lower scores indicating a better quality of life with respect to GI symptoms and higher scores indicating a lower quality of life with respect to GI symptoms. Baseline was defined as the assessment done on Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, 14 and 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day 1, Randomization) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.||Scores on scale||Standard Deviation|Mean
856323|NCT01488994|Secondary|Health Resource Use: Number of Hospitalizations|The number of hospitalizations per participant. Number of participants contributing data (N) for this outcome measure is included in the category title in the order: pediatric participants < 6 years of age; pediatric participants 6 to <12 years of age; Full Analysis Set.|Baseline (Pharmacokinetic [PK] assessment), Week 5, Week 13 and Week 26|||Hospitalizations||Full Range|Median
856190|NCT01725126|Primary|Change From Baseline in ECG Intervals During Part B and C|Single 12-lead ECGs was obtained after participants rested in a supine position for at least 10 minutes using an ECG machine that automatically calculated the HR and measured PR, QRS, QT, QTcB, QTcF and RR intervals. The assessments were done at Day -1 (pre-dose, triplicate), Day 42 (pre-dose) and Follow-up Visit. Baseline value was defined as the average of the triplicate pre-dose assessments done on Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 42 and Follow-up) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day -1) up to Follow-up (Day 56)|All Subjects Population. Only those participants available at the specified time points were analyzed.||Milliseconds||Standard Deviation|Mean
856191|NCT01725126|Primary|Change From Baseline in Electrocardiogram (ECG) Intervals During Part A|Single 12-lead ECGs was obtained after participants rested in a supine position for at least 10 minutes using an ECG machine that automatically calculated the HR and measured PR, QRS, QT, QT duration corrected for HR by Fridericia’s formula (QTcF) and QT duration corrected for HR by Bazett’s formula (QTcB intervals. The assessments were done at Day 1 (pre-dose, triplicate), Day 42 (pre-dose) and Follow-up Visit. Baseline value was defined as the average of the triplicate pre-dose assessments done on Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 42 and Follow-up) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day 1, Randomization) up to Follow-up (Day 56)|All Subjects Population. Only those participants available at the specified time points were analyzed.||Milliseconds||Standard Deviation|Mean
856192|NCT01725126|Primary|Change From Baseline in Vital Sign Parameter of HR During the Double-blind Treatment Period of Part B and C|Vital sign assessments were performed after resting in a supine or semi-supine position for at least 10 minutes. The assessments were done pre-dose at Day -1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day -1) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.||Beats per minute||Standard Deviation|Mean
856193|NCT01725126|Primary|Change From Baseline in Vital Sign Parameter of Heart Rate (HR) During the Double-blind Treatment Period of Part A|Vital sign assessments were performed after resting in a supine or semi-supine position for at least 10 minutes. The assessments were done pre-dose at Day 1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day 1, Randomization) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.||Beats per minute||Standard Deviation|Mean
856194|NCT01725126|Primary|Change From Baseline in Vital Sign Parameter of SBP and DBP During the Double-blind Treatment Period of Part B and C|Vital sign assessments were performed after resting in a supine or semi-supine position for at least 10 minutes. The assessments were done pre-dose at Day -1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day -1) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.||mmHg||Standard Deviation|Mean
856195|NCT01725126|Primary|Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) During the Double-blind Treatment Period of Part A|Vital sign assessments were performed after resting in a supine or semi-supine position for at least 10 minutes. The assessments were done pre-dose at Day 1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day 1, Randomization) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.||Millimeters of mercury (mmHg)||Standard Deviation|Mean
856196|NCT01725126|Primary|Mean pH Values of Urine During the Double-blind Treatment Period of Part B and C|Urinalysis parameter included urine pH. pH was calculated on a scale of 0 to 14, such that, the lower the number, more acidic the urine and higher the number, more alkaline the urine with 7 being neutral. The assessments were done pre-dose on Day -1, Day 7, Day 14, Day 28 and Day 42.|Up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.||pH||Standard Deviation|Mean
856197|NCT01725126|Primary|Mean pH Values of Urine During the Double-blind Treatment Period of Part A|Urinalysis parameter included urine pH. pH was calculated on a scale of 0 to 14, such that, the lower the number, more acidic the urine and higher the number, more alkaline the urine with 7 being neutral. The assessments were done pre-dose on Day 1, Day 7, Day 14, Day 28 and Day 42.|up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.||pH||Standard Deviation|Mean
856198|NCT01725126|Primary|Mean Specific Gravity Values of Urine During the Double-blind Treatment Period of Part B and C|Urinary specific gravity is a measure of the concentration of solutes in urine. It measures the ratio of urine density compared with water density and provides information on the kidney's ability to concentrate urine. The assessments were done pre-dose at Day -1, Day 7, Day 14, Day 28 and Day 42.|Up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.||Ratio||Standard Deviation|Mean
856199|NCT01725126|Primary|Mean Specific Gravity Values of Urine During the Double-blind Treatment Period of Part A|Urinary specific gravity is a measure of the concentration of solutes in urine. It measures the ratio of urine density compared with water density and provides information on the kidney's ability to concentrate urine. The assessments were done pre-dose at Da y 1, Day 7, Day 14, Day 28 and Day 42.|Up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.||Ratio||Standard Deviation|Mean
856200|NCT01725126|Primary|Number of Participants With Abnormal Urinalyisis Dipstick and Microscopic Results During the Double-blind Treatment Period of Part C|The assessments were done pre-dose at Day -1, Day 7, Day 14, Day 28 and Day 42. The participants were categorized as few, many, moderate, trace, +1, 2+, 3+, 0-3, 10-20, 0-5, 6-10, 20-40, 40-60. Protein and ketone ranged from trace to 1+, trace indicated lowest and 1+ indicated highest concentration. Bacteria and uric acid crystals ranged from few to moderate, few indicated lowest and moderate indicated highest concentration. Trace was the highest concentration of occult blood. Epithelial cells ranged from 0-5 to >10, 0-5 indicated lowest and >10 indicated highest concentration. Glucose ranged from trace to 3+, trace indicated lowest and 3+ indicated highest concentration. 0-1 was highest concentration for hyaline casts. RBC and WBC ranged from 0-3 to 40-60, 0-3 indicated lowest and 20-40 indicated highest concentration. Highest concentration indicated worse outcome.|Up to Day 42|All Subjects Population.||Participants|||Count of Participants
856201|NCT01725126|Primary|Number of Participants With Abnormal Urinalyisis Dipstick and Microscopic Results During the Double-blind Treatment Period of Part B|The assessments were done pre-dose at Day -1, Day 7, Day 14, Day 28 and Day 42. Only those parameters for which at least one value of abnormal urinalysis result was reported are summarized. The participants were categorized as few, trace, +1, 2+, 3+, 0-3, 10-20, 0-5, 6-10, and 20-40. Few was the highest concentration of bacteria. Occult blood ranged from trace to 1+, trace indicated lowest and 1+ indicated highest concentration. Epithelial cell ranged from 0-5 to 10-20, 0-5 indicated lowest and 10-20 indicated highest concentration. Glucose ranged from trace to 3+, trace indicated lowest and 3+ indicated highest concentration. 0-5 was highest concentration for hyaline casts. Ketone ranged from trace to 1+, trace indicated lowest and 1+ indicated highest concentration. RBC and WBC ranged from 0-3 to 20-40, 0-3 indicated lowest and 20-40 indicated highest concentration. Highest concentration indicated worse outcome.|Up to Day 42|All Subjects Population.||Participants|||Count of Participants
856202|NCT01725126|Primary|Number of Participants With Abnormal Urinalyisis Dipstick and Microscopic Results During the Double-blind Treatment Period of Part A|The assessments were done pre-dose at Day 1, Day 7, Day 14, Day 28 and Day 42. Only those parameters for which at least one value of abnormal urinalysis result was reported are summarized. The participants were categorized as rare, trace, +1, 2+, RBC’s and WBC’s as <1, 1, 2, 3 and 4. Protein concentration ranged from trace to 1+, where trace indicated lowest concentration and 1+ indicated highest concentration. Trace was the highest concentration for occult blood. Bacteria concentration ranged from rare to moderate, where rare indicated lowest concentration and moderate indicated highest concentration. Ketones ranged from trace to 1+, where trace indicated lowest concentration and 1+ indicated highest concentration. RBC and WBC ranged from <1 to 4, where <1 indicated lowest concentration and 4 indicated highest concentration. Highest concentration indicated worse outcome.|Up to Day 42|All Subjects Population.||Participants|||Count of Participants
856203|NCT01725126|Primary|Change From Baseline in Hematology Parameter of MCV During the Double-blind Treatment Period of Part B and C|The assessments were done pre-dose at Day -1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day -1) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.||Femtoliters||Standard Deviation|Mean
856204|NCT01725126|Primary|Change From Baseline in Hematology Parameter of Mean Corpuscle Volume (MCV) During the Double-blind Treatment Period of Part A|The assessments were done pre-dose at Day 1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day 1, Randomization) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.||Femtoliters||Standard Deviation|Mean
856205|NCT01725126|Primary|Change From Baseline in Hematology Parameter of MCH During the Double-blind Treatment Period of Part B and C|The assessments were done pre-dose at Day -1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day -1) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.||Picograms||Standard Deviation|Mean
856206|NCT01725126|Primary|Change From Baseline in Hematology Parameter of Mean Corpuscle Hemoglobin (MCH) During the Double-blind Treatment Period of Part A|The assessments were done pre-dose at Day 1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day 1, Randomization) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.||Picograms||Standard Deviation|Mean
856207|NCT01725126|Primary|Change From Baseline in Hematology Parameter of Hematocrit During the Double-blind Treatment Period of Part B and C|The assessments were done pre-dose at Day -1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day -1) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.||Ratio||Standard Deviation|Mean
856208|NCT01725126|Primary|Change From Baseline in Hematology Parameter of Hematocrit During the Double-blind Treatment Period of Part A|The assessments were done pre-dose at Day 1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day 1, Randomization) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.||Ratio||Standard Deviation|Mean
856209|NCT01725126|Primary|Change From Baseline in Hematology Parameters of RBC Count and Reticulocytes During the Double-blind Treatment Period of Part B and C|The assessments were done pre-dose at Day -1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day -1) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.||TI/L||Standard Deviation|Mean
856210|NCT01725126|Primary|Change From Baseline in Hematology Parameters of Red Blood Cell (RBC) Count and Reticulocytes During the Double-blind Treatment Period of Part A|The assessments were done pre-dose at Day 1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day 1, Randomization) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.||Trillion cells (TI)/L||Standard Deviation|Mean
856211|NCT01725126|Primary|Change From Baseline in Hematology Parameters of Hemoglobin and MCHC During the Double-blind Treatment Period of Part B and C|The assessments were done pre-dose at Day -1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day -1) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.||g/L||Standard Deviation|Mean
856212|NCT01725126|Primary|Change From Baseline in Hematology Parameters of Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) During the Double-blind Treatment Period of Part A|The assessments were done pre-dose at Day 1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day 1, Randomization) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.||g/L||Standard Deviation|Mean
856213|NCT01725126|Primary|Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count During the Double-blind Treatment Period of Part B and C|The assessments were done pre-dose at Day -1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day -1) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.||GI/L||Standard Deviation|Mean
856214|NCT01725126|Primary|Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count During the Double-blind Treatment Period of Part A|The assessments were done pre-dose at Day 1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day 1, Randomization) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.||Giga cells (GI)/L||Standard Deviation|Mean
856215|NCT01725126|Primary|Change From Baseline in Clinical Chemistry Parameters of Thyroid Stimulating Hormone During the Double-blind Treatment Period of Part B and C|The assessments were done pre-dose at Day -1, Day 7 and Day 42. Baseline value was defined as the assessment done Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day -1) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.||Milliunits (mu/L)||Standard Deviation|Mean
856216|NCT01725126|Primary|Change From Baseline in Clinical Chemistry Parameters of Total Thyroxine and Total T3 During the Double-blind Treatment Period of Part B and C|The assessments were done pre-dose at Day -1 and Day 42. Baseline value was defined as the assessment done Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 42) value. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day -1) and Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.||Nanomoles (nmol)/L||Standard Deviation|Mean
856217|NCT01725126|Primary|Change From Baseline in Clinical Chemistry Parameter of Triiodothyronine (T3) Uptake During the Double-blind Treatment Period of Part B and C|The assessments were done pre-dose at Day -1 and Day 42. Baseline value was defined as the assessment done Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 42) value. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day -1) and Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.||Ratio||Standard Deviation|Mean
856218|NCT01725126|Primary|Change From Baseline in Clinical Chemistry Parameters of Amylase and Lipase the Double-blind Treatment Period of Part B of Study|The assessments were done pre-dose at Day -1 and Day 42. Baseline value was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 42) value. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day -1) and Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.||Units (U)/L||Standard Deviation|Mean
856358|NCT01485796|Secondary|Rate of Related Local Adverse Events (Excluding Infections) Per Infusion|A point estimate and 95% confidence interval for the rate of related local adverse events per infusion was derived using a Poisson model.|7 months (per subject)|||adverse events||95% Confidence Interval|Number
856219|NCT01725126|Primary|Change From Baseline in Clinical Chemistry Parameters of Insulin During the Double-blind Treatment Period of Part B and C|The assessments were done pre-dose at Day -1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day -1) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.||pmol/L||Standard Deviation|Mean
856220|NCT01725126|Primary|Change From Baseline in Clinical Chemistry Parameters of Insulin During the Double-blind Treatment Period of Part A|The assessments were done pre-dose at Day 1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day 1, Randomization) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.||Picomoles (pmol)/L||Standard Deviation|Mean
856221|NCT01725126|Primary|Change From Baseline in Clinical Chemistry Parameters of Albumin and Total Protein During the Double-blind Treatment Period of Part B and C|The assessments were done pre-dose at Day -1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day -1) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.||g/L||Standard Deviation|Mean
856222|NCT01725126|Primary|Change From Baseline in Clinical Chemistry Parameters of Albumin and Total Protein During the Double-blind Treatment Period of Part A|The assessments were done pre-dose at Day 1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day 1, Randomization) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.||g/L||Standard Deviation|Mean
856223|NCT01725126|Primary|Change From Baseline in Clinical Chemistry Parameters of Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid During the Double-blind Treatment Period of Part B and C|The assessments were done pre-dose at Day -1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day -1) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.||umol/L||Standard Deviation|Mean
856224|NCT01725126|Primary|Change From Baseline in Clinical Chemistry Parameters of Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid During the Double-blind Treatment Period of Part A|The assessments were done pre-dose at Day 1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day 1, Randomization) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.||Micromoles (umol)/L||Standard Deviation|Mean
856225|NCT01725126|Primary|Change From Baseline in Clinical Chemistry Parameters of Electrolytes, Glucose Phosphorus Inorganic, BUN and Cholesterol During the Double-blind Treatment Period of Part B and C|The electrolytes include calcium, chloride, carbon dioxide content/bicarbonate, potassium, magnesium and sodium. Assessments were done pre-dose at Day -1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day -1) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.||mmol/L||Standard Deviation|Mean
856226|NCT01725126|Primary|Change From Baseline in Clinical Chemistry Parameters of Electrolytes, Glucose Phosphorus Inorganic and Urea/Blood Urea Nitrogen (BUN) During the Double-blind Treatment Period of Part A|The electrolytes include calcium, chloride, carbon dioxide content/bicarbonate, potassium, magnesium and sodium. Assessments were done pre-dose at on Day 1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day 1, Randomization) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.||Millimoles (mmol)/L||Standard Deviation|Mean
856227|NCT01725126|Primary|Change From Baseline in Clinical Chemistry Parameters of ALP, ALT, AST and GGT During the Double-blind Treatment Period of Part B and C|The assessments were done pre-dose at Day -1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day -1) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.||IU/L||Standard Deviation|Mean
856228|NCT01725126|Primary|Change From Baseline in Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), ALT, Aspartate Aminotransferase (AST) and Gamma Glutamyltransferase (GGT) During Double-blind Treatment Period of Part A|The assessments were done pre-dose at Day 1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day 1, Randomization) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.||International unit per liter (IU/L)||Standard Deviation|Mean
856229|NCT01725126|Primary|Number of Participants With Any Hypoglycemic Events During Part B and Part C|Hypoglycemia is defined as symptoms consistent with hypoglycemia (e.g. dizziness, light-headedness, shakiness) which are confirmed by glucometer measurement of CBG or plasma glucose value of <50 mg/dL for Part A or <70 mg/dL for Parts B and C (when possible, CBG values were confirmed with a laboratory measurement). In situations when no glucose sample could be measured at the time of the event, the investigator, at his or her discretion, characterized an event as ‘hypoglycemia’ based on reported signs and symptoms alone. Healthy participant also had asymptomatic blood glucose values <70 mg/dL as a physiological response to altered food intake (e.g., fasting).|Up to Follow-up (8 weeks)|All Subjects Population.||Participants|||Count of Participants
856230|NCT01725126|Primary|Number of Participants With Any Hypoglycemic Events During Part A|Hypoglycemia is defined as symptoms consistent with hypoglycemia (e.g. dizziness, light-headedness, shakiness) which are confirmed by glucometer measurement of complete blood count (CBG) or plasma glucose value of <50 milligram per deciliter (mg/dL) for Part A or <70 mg/dL for Parts B and C (when possible, CBG values were confirmed with a laboratory measurement). In situations when no glucose sample could be measured at the time of the event, the investigator, at his or her discretion, characterized an event as ‘hypoglycemia’ based on reported signs and symptoms alone. Healthy participant also had asymptomatic blood glucose values <70 mg/dL as a physiological response to altered food intake (e.g., fasting).|Up to Follow-up (8 weeks)|All Subjects Population.||Participants|||Count of Participants
856231|NCT01725126|Primary|Number of Participants With Any AE, SAE or Death During Part B and Part C|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, associated with liver injury and impaired liver function defined as ALT >=3 x ULN, and total bilirubin >=2 x ULN or international normalized ratio >1.5.|Up to Follow-up (8 weeks)|All Subjects Population.||Participants|||Count of Participants
856232|NCT01725126|Primary|Number of Participants With Any Adverse Event (AE), Serious Adverse Event (SAE) or Death During Part A|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, associated with liver injury and impaired liver function defined as alanine aminotransferase (ALT) >=3 x upper limit of normal (ULN), and total bilirubin >=2 x ULN or international normalized ratio >1.5.|Up to Follow-up (8 weeks)|All Subjects Population comprised of all randomized participants who received at least one dose of study medication (placebo or GSK2890457).||Participants|||Count of Participants
856359|NCT01485796|Secondary|Number of Related Local Adverse Events (Excluding Infections)||7 months (per subject)|||adverse events|||Number
856253|NCT01614093|Primary|Food Consumption After Intervention|"We hypothesize that participants will have greater satiety signaling, indicated by less consumption of the Test Meal consumed 90 minutes after the preload."|90 minutes|||Grams||Standard Deviation|Mean
856288|NCT01507896|Primary|Incremental Recovery (IR) at 15±5 Minutes Following Loading Dose Prior to Surgery|IR was defined as (C post-infusion - C pre-infusion) / Dose, where C post-infusion is the measured concentration achieved at 15±5 minutes for the loading dose.|Within 60 minutes prior to surgery and 15 ± 5 minutes after loading dose/rebolus, if applicable.|"Participants in the Full Analysis Set (exposed to BAX326 and provided suitable hemostatic efficacy data) who provided data for incremental recovery (IR) after the loading dose prior to surgery.
Note: a unique participant could have more than one surgical procedure."||[IU/dL] : [IU/kg]|surgeries with IR data|Standard Deviation|Mean
856360|NCT01485796|Secondary|Proportion of Subjects Who Maintain a Treatment Interval of 3 or 4 Weeks in Epoch 2 for 24 Weeks||6 months (per subject)|||subjects|||Number
856361|NCT01485796|Secondary|Proportion of Subjects Who Achieve a Treatment Interval of 3 or 4 Weeks in Epoch 2||6 months (per subject)|||subjects|||Number
856282|NCT01508910|Secondary|Percentage of Participants With at Least One Serious Adverse Event (SAE) From Randomization Until the End of the 24 Month Follow-up Period||From randomization until the end of the 24 month follow-up period|Safety Population as Treated.||percent|||Number
856283|NCT01508910|Secondary|Percentage of Participants With Incidences of MACE From Randomization Until the End of the 24 Month Follow-up Period|"Major adverse cardiac events (MACE) defined as death, cardiac hospitalization, non-fatal myocardial infarction and stroke, as adjudicated by an independent clinical endpoint classification (CEC) committee.
The category Total MACE includes death, cardiovascular hospitalization, myocardial infarction or stroke."|From randomization until the end of the 24 month follow-up period|Participants in the safety population as Treated.||percent||95% Confidence Interval|Number
856284|NCT01508910|Secondary|Angina Frequency (Episodes Per Week) at the 6 Month Follow-up Visit||6 month visit|Participants in the Intent to Treat population defined as participants randomized to Treatment or Active Control arms. For participants not receiving intramyocardial injections, the missing values were imputed i.e. replaced with substituted values from the baseline.||angina episodes per week||Standard Deviation|Mean
856285|NCT01508910|Secondary|Change From Baseline in Total Exercise Time on Exercise Tolerance Test (ETT) at the 6 Month Follow-up Visit|Baseline (BL) is the average of the two total exercise times measured during the screening period.|Baseline and 6 month visit|Participants in the Intent to Treat population defined as participants randomized to Treatment or Active Control arms. For participants not receiving intramyocardial injections, the missing values were imputed i.e. replaced with substituted values from the baseline.||seconds||Standard Deviation|Mean
856286|NCT01508910|Secondary|Angina Frequency (Episodes Per Week) at the 12 Month Follow-up Visit|Participants self-reported angina episodes utilizing an electronic diary for 4 weeks at baseline (screening period) and in the 4 weeks before the 3, 6 and 12 month follow-up visits.|Baseline and 12 month visit|Participants in the Intent to Treat population defined as participants randomized to Treatment or Active Control arms. For participants not receiving intramyocardial injections, the missing values were imputed i.e. replaced with substituted values from the baseline.||angina episodes per week||Standard Deviation|Mean
856287|NCT01508910|Primary|Change From Baseline in Total Exercise Time on Exercise Tolerance Test (ETT) Using the Modified Bruce Protocol|Baseline (BL) is the average of the two total exercise times measured during the screening period.|Baseline and 12 month visit|Participants in the Intent to Treat population defined as participants randomized to Treatment or Active Control arms. For participants not receiving intramyocardial injections, the missing values were imputed i.e. replaced with substituted values from the baseline.||seconds||Standard Deviation|Mean
856289|NCT01507896|Primary|Pre-Surgical Pharmacokinetics (PK): Volume of Distribution at Steady State (Vss)|Vss was computed as CL·MRT.|Within 30 mins pre-infusion and post-infusion timepoints of 30 minutes, 6 hr, 24 hr, 48 hr and 72 hr|"Participants in the Full Analysis Set (exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) who underwent a pre-surgical PK assessment in this study i.e.not participants who underwent a PK assessment in the pivotal study (250901).
Note: a unique participant could have a pre-surgical PK assessment for more than one surgery."||dL/kg|pre-surgical PK assessments|Standard Deviation|Mean
856290|NCT01507896|Primary|Pre-Surgical Pharmacokinetics (PK): Elimination Phase Half-life (T 1/2)|T1/2 was determined as ln2 / λz.|Within 30 mins pre-infusion and post-infusion timepoints of 30 minutes, 6 hr, 24 hr, 48 hr and 72 hr|"Participants in the Full Analysis Set (exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) who underwent a pre-surgical PK assessment in this study i.e.not participants who underwent a PK assessment in the pivotal study (250901).
Note: a unique participant could have a pre-surgical PK assessment for more than one surgery."||hours (hr)|pre-surgical PK assessments|Standard Deviation|Mean
856291|NCT01507896|Primary|Pre-Surgical Pharmacokinetics (PK): Incremental Recovery (IR) at 30 Min|IR was defined as (C post-infusion - C pre-infusion) / Dose, where C post-infusion is the measured concentration achieved at 30±5 minutes for pre-surgical PK.|Within 30 mins pre-infusion and post-infusion at 30 minutes|"Participants in the Full Analysis Set (exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) who underwent a pre-surgical PK assessment in this study i.e.not participants who underwent a PK assessment in the pivotal study (250901).
Note: a unique participant could have a pre-surgical PK assessment for more than one surgery."||IU/dL : IU/kg|pre-surgical PK assessments|Standard Deviation|Mean
856292|NCT01507896|Primary|Pre-Surgical Pharmacokinetics (PK): Factor IX (FIX) Clearance (CL)|CL is the volume of plasma which is completely cleared of study product per unit time and is calculated as the dose divided by the total area under the curve from 0 to infinity (AUC0-inf).|Within 30 mins pre-infusion and post-infusion timepoints of 30 minutes, 6 hr, 24 hr, 48 hr and 72 hr|"Participants in the Full Analysis Set (exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) who underwent a pre-surgical PK assessment in this study i.e.not participants who underwent a PK assessment in the pivotal study (250901).
Note: a unique participant could have a pre-surgical PK assessment for more than one surgery."||dL/(kg•hr)|pre-surgical PK assessments|Standard Deviation|Mean
856293|NCT01507896|Primary|Pre-Surgical Pharmacokinetics (PK): Mean Residence Time (MRT)|The MRT is the average time that the study product stays in the body (or plasma) and is calculated as: AUMC 0-inf / AUC 0-inf, where AUMC 0-inf was determined in a similar manner as AUC 0-inf.|Within 30 mins pre-infusion and post-infusion timepoints of 30 minutes, 6 hr, 24 hr, 48 hr and 72 hr|"Participants in the Full Analysis Set (exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) who underwent a pre-surgical PK assessment in this study i.e.not participants who underwent a PK assessment in the pivotal study (250901).
Note: a unique participant could have a pre-surgical PK assessment for more than one surgery."||hours (hr)|pre-surgical PK assessments|Standard Deviation|Mean
856294|NCT01507896|Primary|Pre-Surgical Pharmacokinetics (PK): Total Area Under the Plasma Concentration Versus Time Curve Per Dose (Total AUC/Dose)|Total AUC/Dose is also AUC0-inf (area under the plasma concentration/time curve from time 0 to infinity) and was defined as AUC0-t + Ct / λz, where t is the time of last quantifiable concentration, Ct is the last quantifiable concentration and λz is the terminal rate constant.|Within 30 mins pre-infusion and post-infusion timepoints of 30 minutes, 6 hr, 24 hr, 48 hr and 72 hr|"Participants in the Full Analysis Set (exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) who underwent a pre-surgical PK assessment in this study i.e.not participants who underwent a PK assessment in the pivotal study (250901).
Note: a unique participant could have a pre-surgical PK assessment for more than one surgery."||[IU•hour (hr)/dL] : IU/kg|pre-surgical PK assessments|Standard Deviation|Mean
856295|NCT01507896|Primary|Pre-Surgical Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve (AUC) From 0 to 72 Hours Post-infusion Per Dose|AUC0-72h (area under the plasma concentration/time curve from time 0 to 72 hours) was computed using the linear trapezoidal method. The concentration at 72 hours was interpolated from the two nearest sampling time points or extrapolated using the last quantifiable concentration and the terminal rate constant λz. λz was estimated from the slope of natural log-linear fitting to latter quantifiable concentrations, with largest adjusted R2.|Within 30 mins pre-infusion and post-infusion timepoints of 30 minutes, 6 hr, 24 hr, 48 hr and 72 hr|"Participants in the Full Analysis Set (exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) who underwent a pre-surgical PK assessment in this study i.e.not participants who underwent a PK assessment in the pivotal study (250901).
Note: a unique participant could have a pre-surgical PK assessment for more than one surgery."||[IU•hour (hr)/dL] : IU/kg|pre-surgical PK assessments|Standard Deviation|Mean
856296|NCT01507896|Primary|Safety: Occurence of a Thrombotic Event||Throughout the study period (approximately 2 years 5 months)|"All participants in the Safety Analysis Set (participants exposed to BAX326 during the study).
Note: a unique participant could be treated with BAX326 for more than one surgical procedure."||surgeries|treatments with BAX326 before surgery||Number
856297|NCT01507896|Primary|Safety: Number of Adverse Events Related to BAX326||Throughout the study period (approximately 2 years 5 months)|"All participants in the Safety Analysis Set (participants exposed to BAX326 during the study).
Note: a unique participant could be treated with BAX326 for more than one surgical procedure."||adverse events|treatments with BAX326 before surgery||Number
856298|NCT01507896|Primary|Safety: Number of Participants Who Developed Total Binding Antibodies to Factor IX (FIX)|If there was more than 2-dilution increase as compared to pre-study level at screening.|Throughout the study period (approximately 2 years 5 months)|"All participants in the Safety Analysis Set (participants exposed to BAX326 during the study).
Note: a unique participant could be treated with BAX326 for more than one surgical procedure."||participants|treatments with BAX326 before surgery||Number
856299|NCT01507896|Primary|Safety: Number of Participants Who Developed Inhibitory Antibodies to Factor IX (FIX)||Throughout the study period (approximately 2 years 5 months)|"All participants in the Safety Analysis Set (participants exposed to BAX326 during the study).
Note: a unique participant could be treated with BAX326 for more than one surgical procedure."||participants|treatments with BAX326 before surgery||Number
856300|NCT01507896|Primary|Volume of Blood Product Transfused|Blood product transfusions consisted of packed red blood cells (PRBC) or fresh frozen plasma (FFP) or both.|From initiation of surgery until discharge from hospital (from 1-3 days postoperatively for minor surgery and approximately 2 weeks postoperatively for major surgery)|"Participants in the Full Analysis Set (exposed to BAX326 and provided suitable hemostatic efficacy data) who received blood product infusions during the intraoperative and/or postoperative period.
Note: a unique participant could have more than one surgical procedure."||mL|surgery where blood transfusion given|Standard Deviation|Mean
856301|NCT01507896|Primary|Number of Units of Blood Product Transfused|Blood product transfusions consisted of packed red blood cells (PRBC) or fresh frozen plasma (FFP) or both.|From initiation of surgery until discharge from hospital (from 1-3 days postoperatively for minor surgery and approximately 2 weeks postoperatively for major surgery)|"Participants in the Full Analysis Set (exposed to BAX326 and provided suitable hemostatic efficacy data) who received blood product infusions during the intraoperative and/or postoperative period.
Note: a unique participant could have more than one surgical procedure."||units|surgery where blood transfusion given|Standard Deviation|Mean
856302|NCT01507896|Primary|Total Weight-Adjusted Dose of BAX326 Per Participant|Assessed for the intra- and postoperative periods.|From initiation of surgery until discharge from hospital (from 1-3 days postoperatively for minor surgery and approximately 2 weeks postoperatively for major surgery)|"All participants in the Full Analysis Set (participants exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) treated with BAX326 per surgical procedure.
Note: a unique participant could have more than one surgical procedure."||IU/kg|surgeries|Standard Deviation|Mean
856303|NCT01507896|Primary|Daily Weight-Adjusted Dose of BAX326 Per Participant|"Daily weight-adjusted doses of BAX326 per participant were recorded from the day of surgery until postoperative Days 11+.
Each category in outcome measure includes number of all, major and minor surgeries, respectively, if different from the totals."|From initiation of surgery until discharge from hospital (from 1-3 days postoperatively for minor surgery and approximately 2 weeks postoperatively for major surgery)|"All participants in the Full Analysis Set (participants exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) treated with BAX326 per surgical procedure.
Note: a unique participant could have more than one surgical procedure."||IU/kg|surgeries|Standard Deviation|Mean
856304|NCT01507896|Primary|Actual Postoperative Blood Loss Compared to Average and Maximum Blood Loss Predicated Preoperatively by the Operating Surgeon|"Predicted average/maximum blood loss minus actual blood loss for participants who had a drain placed during surgery.
Prior to the surgery, the surgeon will predict the estimated volume (mL) of the expected average and maximum blood loss for the planned surgical intervention in a hemostatically normal individual of the same sex, age, and stature as the study subject for the postoperative period until drain removal."|At postoperative day 3 (approximately 72 hours postoperatively)|"Participants in the Full Analysis Set (participants exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) who had a drain placed during surgery (major surgeries only).
Note: a unique participant could have more than one surgical procedure."||mL|surgeries with drain placed|Standard Deviation|Mean
856305|NCT01507896|Primary|Actual Postoperative Blood Loss|Postoperative blood loss was based on the drainage fluid and was only assessed for participants who had a drain placed during surgery.|At drain removal (from 1-3 days postoperatively)|"Participants in the Full Analysis Set (participants exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) who had a drain placed during surgery (major surgeries only).
Note: a unique participant could have more than one surgical procedure."||mL|surgeries with drain placed|Standard Deviation|Mean
856306|NCT01507896|Primary|Postoperative Hemostatic Efficacy on Day of Discharge|"Assessment by the operating surgeon on a 4 point ordinal scale:
Excellent: Postoperative hemostasis achieved with BAX326 was as good or better than that expected for the type of surgical procedure performed in a hemostatically normal participant
Good: Postoperative hemostasis achieved with BAX326 was probably as good as that expected for the type of surgical procedure performed in a hemostatically normal participant
Fair: Postoperative hemostasis with BAX326 was clearly less than optimal for the type of procedure performed but was maintained without the need to change the Factor IX concentrate
None: Participant experienced uncontrolled bleeding that was the result of inadequate therapeutic response despite proper dosing, necessitating a change of Factor IX concentrate"|At discharge from hospital (from 1-3 days postoperatively for minor surgery and approximately 2 weeks postoperatively for major surgery)|"All participants in the Full Analysis Set (participants exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) treated with BAX326 per surgical procedure.
Note: a unique participant could have more than one surgical procedure."||surgeries|surgeries||Number
856307|NCT01507896|Primary|Postoperative Hemostatic Efficacy at Postoperative Day 3|"Assessment by the operating surgeon on a 4 point ordinal scale:
Excellent: Postoperative hemostasis achieved with BAX326 was as good or better than that expected for the type of surgical procedure performed in a hemostatically normal participant
Good: Postoperative hemostasis achieved with BAX326 was probably as good as that expected for the type of surgical procedure performed in a hemostatically normal participant
Fair: Postoperative hemostasis with BAX326 was clearly less than optimal for the type of procedure performed but was maintained without the need to change the Factor IX concentrate
None: Participant experienced uncontrolled bleeding that was the result of inadequate therapeutic response despite proper dosing, necessitating a change of Factor IX concentrate"|At postoperative day 3 (approximately 72 hours postoperatively)|"Participants in the Full Analysis Set who were provided with a hemostatic efficacy assessment by the operating surgeon at post operative day 3 where no drain was employed.
Note: a unique participant could have more than one surgical procedure."||surgeries|surgeries||Number
856320|NCT01488994|Secondary|Health Resource Use: Emergency Room Visits|The number of Emergency Room visits per participant. Number of participants contributing data (N) for this outcome measure is included in the category title in the order: pediatric participants < 6 years of age; pediatric participants 6 to <12 years of age; Full Analysis Set.|Baseline (Pharmacokinetic [PK] assessment), Week 5, Week 13 and Week 26|||Visits||Full Range|Median
856321|NCT01488994|Secondary|Health Resource Use: Unscheduled Doctor's Office Visits|The number of unscheduled doctor's Office visits per participant. Number of participants contributing data (N) for this outcome measure is included in the category title in the order: pediatric participants < 6 years of age; pediatric participants 6 to <12 years of age; Full Analysis Set.|Baseline (Pharmacokinetic [PK] assessment), Week 5, Week 13 and Week 26|Participants who had unscheduled visits to a doctor's office||Visits||Full Range|Median
856308|NCT01507896|Primary|Postoperative Hemostatic Efficacy at Drain Removal|"The postoperative hemostatic efficacy was to be assessed by the operating surgeon according to the following criteria (4-point ordinal scale):
Excellent: Volume in drain was less than or equal than that expected for the type of procedure performed in a hemostatically normal participant (≤ 100% )
Good: Volume in drain was up to 50% more than expected for the type of procedure performed in a hemostatically normal participant (101% - 150%)
Fair: Volume in drain was more than 50% of that expected for the type of procedure performed in a hemostatically normal participant (> 150%)
None: Uncontrolled bleeding that was the result of inadequate therapeutic response despite proper dosing, necessitating a change of Factor IX concentrate"|At drain removal (from 1-3 days postoperatively)|"Participants in the Full Analysis Set (participants exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) who had a drain placed during surgery (major surgeries only).
Note: a unique participant could have more than one surgical procedure"||major surgeries with drain placed|major surgeries with drain placed||Number
856309|NCT01507896|Primary|Actual Intraoperative Blood Loss Compared to Average and Maximum Blood Loss Predicted Preoperatively by the Operating Surgeon|Predicted average/maximum blood loss minus actual blood loss. Prior to the surgery, the surgeon predicted the estimated volume (mL) of the expected average and maximum blood loss for the planned surgical intervention in a hemostatically normal individual of the same sex, age, and stature as the study participant for the intraoperative period.|On day of surgery|"All participants in the Full Analysis Set (participants exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) treated with BAX326 per surgical procedure.
Note: a unique participant could have more than one surgical procedure."||mL|surgeries|Standard Deviation|Mean
856310|NCT01507896|Primary|Actual Intraoperative Blood Loss|Actual intraoperative blood loss was determined by the drainage volume, if a drain was placed, and the estimated blood loss into swabs and towels during the procedure.|On day of surgery|"All participants in the Full Analysis Set (participants exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) treated with BAX326 per surgical procedure.
Note: a unique participant could have more than one surgical procedure."||mL|surgeries|Standard Deviation|Mean
856311|NCT01507896|Primary|Intraoperative Hemostatic Efficacy|"Assessment by the operating surgeon on a 4 point ordinal scale (according to the definitions provided below):
Excellent: Intraoperative blood loss was less than or equal to that expected for the type of procedure performed in a hemostatically normal participant (≤ 100% )
Good: Intraoperative blood loss was up to 50% more than expected for the type of procedure performed in a hemostatically normal participant (101 – 150%)
Fair: Intraoperative blood loss was more than 50% of that expected for the type of procedure performed in a hemostatically normal participant (> 150%)
None: Uncontrolled hemorrhage that was the result of inadequate therapeutic response despite proper dosing, necessitating a change of Factor IX concentrate"|On day of surgery|"All participants in the Full Analysis Set (participants exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) treated with BAX326 and had surgery.
Note: a unique participant could have more than one surgical procedure."||surgeries|surgeries||Number
856319|NCT01488994|Secondary|Health Resource Use: Days Lost From School|The number of days lost from school per participant. Number of participants contributing data (N) for this outcome measure is included in the category title in the order: pediatric participants < 6 years of age; pediatric participants 6 to <12 years of age; Full Analysis Set.|Baseline (Pharmacokinetic [PK] assessment), Week 5, Week 13 and Week 26|Participants who missed days from school||Days||Full Range|Median
856324|NCT01488994|Secondary|Health-related Quality of Life (HRQoL): Haemo-QoL, Change From Baseline in Total Score|The Haemo-QoL is a quality of life (QoL) assessment instrument for children and adolescents with haemophilia. As a hemophilia-specific instrument, this measure assesses very specific aspects of dealing with hemophilia. For the Haemo-QoL, higher scores indicate a worse quality of life. Scores on a scale range between 0 and 100.|Baseline and 6 months|Participants in the Full Analysis Set who had Haemo-QoL data for baseline and 6 months||Scores on a scale||Standard Deviation|Mean
856325|NCT01488994|Secondary|Health-related Quality of Life (HRQoL): PedsQL™ Change From Baseline in Total Score|"For this study, the PedsQL™ questionnaires for participants 2 to 7 years of age (parent-proxy versions for age groups 2-4 years and 5-7 years) and PedsQL™ Child version for participants 8 to 12 years of age were used.
The Peds-QL is a generic Health-Related Quality of Life (HR QoL) instrument designed specifically for a pediatric population. It captures the following domains: general health/activities, feelings/emotional, social functioning, school functioning. A 5-point score is used for each domain: from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0 so that higher scores indicate better quality of life (QoL). The total score is the mean (average) of all scores from the 4 domains.
The change from baseline in total score is reported- a positive score indicates a better QoL compared to baseline and a negative score indicates a poorer QoL compared to baseline."|Baseline and 6 months|Participants in the Full Analysis Set who had PedsQL™ data for baseline and 6 months||Scores on a scale||Standard Deviation|Mean
856326|NCT01488994|Secondary|Safety: Number of Participants Who Developed Antibodies to Chinese Hamster Ovary (CHO) Proteins and Recombinant Furin (rFurin)|If more than 2-dilution increase as compared to pre-study level at screening and titers verified for specificity in the confirmatory assay.|Throughout study period (approximately 17 months)|||Participants|||Number
856327|NCT01488994|Secondary|Safety: Number of Participants With Clinically Significant Changes in Routine Laboratory Parameters (Haematology and Clinical Chemistry), and Vital Signs|"Categories consist of Clinically Significant (CS) changes in haemaotology parameters, clinical chemistry parameters and vital signs.
Abbreviations in categories; Clin=clinical; params=parameters"|Throughout study period (approximately 17 months)|||Participants|||Number
856328|NCT01488994|Secondary|Safety: Number of Participants With Thrombotic Events||Throughout study period (approximately 17 months)|||Participants|||Number
856329|NCT01488994|Secondary|Safety: Number of Participants With Severe Allergic Reactions, e.g. Anaphylaxis||Throughout study period (approximately 17 months)|||Participants|||Number
856330|NCT01488994|Secondary|Safety and Immunogenicity: Number of Participants Who Developed Total Binding Antibodies to Factor IX (FIX)|"If more than 2-dilution increase as compared to pre-study level at screening and titers verified for specificity in the confirmatory assay.
AB=antibodies in category for outcome measure data."|Throughout study period (approximately 17 months)|||Participants|||Number
856331|NCT01488994|Secondary|Safety and Immunogenicity: Number of Participants Who Developed Inhibitory Antibodies to Factor IX (FIX)||Throughout study period (approximately 17 months)|||Participants|||Number
856332|NCT01488994|Secondary|Consumption of BAX326: Weight-adjusted Consumption Per Event|Event includes prophylactic infusions of study product and infusions of study product for treatment of bleeding episodes (BEs).|Throughout study period (approximately 17 months)|||IU/kg||Standard Deviation|Mean
856333|NCT01488994|Secondary|Consumption of BAX326: Weight-adjusted Consumption Per Year (Annualized)||Throughout study period (approximately 17 months)|||IU/kg per year||Standard Deviation|Mean
856334|NCT01488994|Secondary|Consumption of BAX326: Weight-adjusted Consumption Per Month||Throughout study period (approximately 17 months)|||IU/kg per month||Standard Deviation|Mean
856335|NCT01488994|Secondary|Consumption of BAX326: Number of Infusions Per Year||Throughout study period (approximately 17 months)|||Infusions per year||Standard Deviation|Mean
856336|NCT01488994|Secondary|Consumption of BAX326: Number of Infusions Per Month||Throughout study period (approximately 17 months)|||Infusions per month||Standard Deviation|Mean
856337|NCT01488994|Secondary|Hemostatic Efficacy: Prophylaxis: Annualized Bleeding Rate (ABR)|"The annualized bleeding rate (ABR) during prophylaxis was calculated only for participants who had adequate treatment time for bleeding rate assessment (i.e., more than 3 months of prophylaxis treatment). The observation period for prophylaxis was to be the time between the first and the last prophylactic infusions. The treatment period for surgery was to be excluded from the bleed rate calculation.
ABR calculated as (Number of bleeding episodes/observed treatment period in days) * 365.25."|Throughout study period (approximately 17 months)|||Bleeding episodes per year||Standard Deviation|Mean
856338|NCT01488994|Secondary|Hemostatic Efficacy: Treatment of Bleeding Episodes: Overall Hemostatic Efficacy Rating at Resolution of Bleed|"Rating Scale for Treatment of bleeding episodes (4-point ordinal scale):
Excellent: Full relief of pain and cessation of objective signs of bleeding (eg, swelling, tenderness, and decreased range of motion in the case of musculoskeletal hemorrhage) after a single infusion. No additional infusion required for the control of bleeding. Administration of further infusions to maintain hemostasis did not affect this scoring.
Good: Definite pain relief and/or improvement in signs of bleeding after a single infusion. Possibly requires more than 1 infusion for complete resolution.
Fair: Probable and/or slight relief of pain and slight improvement in signs of bleeding after single infusion. Required more than 1 infusion for complete resolution.
None: No improvement or condition worsens."|Throughout study period (approximately 17 months)|Participants in the Full Analysis Set who had bleeding episodes||Bleeding Episodes|Bleeding Episodes||Number
856339|NCT01488994|Secondary|Hemostatic Efficacy: Treatment of Bleeding Episodes: Number of Infusions Per Bleeding Episode||Throughout study period (approximately 17 months)|Participants in the Full Analysis Set who had bleeding episodes||Bleeding Episodes|||Number
856340|NCT01488994|Secondary|Pharmacokinetics (PK): Incremental Recovery (IR) Over Time|"IR calculated as follows: (FIX activity at post-infusion minus FIX activity at pre-infusion) divided by weight-adjusted dose. IR is determined at baseline (PK analysis), Week 5, Week 13 and Week 26 timepoints.
Number of participants contributing data (N) for this outcome measure is included in the category title in the order: pediatric participants > 6 years of age; pediatric participants 6 to <12 years of age; pharmacokinetic Full Analysis Set (PKFAS)."|Within 30 mins pre-infusion and 30 mins post-infusion at baseline, Week 5, Week 13 and Week 26.|||IU/dL : IU/kg||Standard Deviation|Mean
856341|NCT01488994|Secondary|Pharmacokinetics (PK): Volume of Distribution at Steady State (Vss)|Computed as Clearance (CL) * Mean residence time (MRT)|Within 30 mins pre-infusion and 4 post-infusion timepoints. Refer to Population Description below for more details.|"All participants randomized to 2 groups:
Group 1 - BAX326 infusion in the morning PK timepoints: Pre-infusion and post-infusion at 15-30 minutes, then 7, 28 and 52 hours Group 2 - BAX326 infusion in the afternoon PK timepoints: Pre-infusion and post-infusion of 15-30 minutes, then 4, 24 and 69 hours"||dL/kg||Standard Deviation|Mean
856342|NCT01488994|Secondary|Pharmacokinetics (PK): Elimination Phase Half-life (T 1/2)|Calculated as log_e2/λ, where λ is the regression slope in the terminal phase of the least absolute deviations regression model|Within 30 mins pre-infusion and 4 post-infusion timepoints. Refer to Population Description below for more details.|"All participants randomized to 2 groups:
Group 1 - BAX326 infusion in the morning PK timepoints: Pre-infusion and post-infusion at 15-30 minutes, then 7, 28 and 52 hours Group 2 - BAX326 infusion in the afternoon PK timepoints: Pre-infusion and post-infusion of 15-30 minutes, then 4, 24 and 69 hours"||hours (hr)||Standard Deviation|Mean
856343|NCT01488994|Secondary|Pharmacokinetics (PK): Incremental Recovery (IR)|The rise in FIX activity in IU/dL per unit dose administered in IU/kg. Calculated as follows: (FIX activity at post-infusion minus FIX activity at pre-infusion) divided by weight-adjusted dose|Within 30 mins pre-infusion and 30 mins post-infusion|||IU/dL : IU/kg||Standard Deviation|Mean
856344|NCT01488994|Secondary|Pharmacokinetics (PK): Factor IX (FIX) Clearance (CL)|Computed as the dose divided by total Area under the curve (AUC)|Within 30 mins pre-infusion and 4 post-infusion timepoints. Refer to Population Description below for more details.|"All participants randomized to 2 groups:
Group 1 - BAX326 infusion in the morning PK timepoints: Pre-infusion and post-infusion at 15-30 minutes, then 7, 28 and 52 hours Group 2 - BAX326 infusion in the afternoon PK timepoints: Pre-infusion and post-infusion of 15-30 minutes, then 4, 24 and 69 hours"||dL/(kg*hr)||Standard Deviation|Mean
856345|NCT01488994|Secondary|Pharmacokinetics (PK): Mean Residence Time (MRT)|Computed as total area under the first moment curve (total AUMC) divided by the total area under the concentration versus time curve (total AUC)|Within 30 mins pre-infusion and 4 post-infusion timepoints. Refer to Population Description below for more details.|"All participants randomized to 2 groups:
Group 1 - BAX326 infusion in the morning PK timepoints: Pre-infusion and post-infusion at 15-30 minutes, then 7, 28 and 52 hours Group 2 - BAX326 infusion in the afternoon PK timepoints: Pre-infusion and post-infusion of 15-30 minutes, then 4, 24 and 69 hours"||hours (hr)||Standard Deviation|Mean
856346|NCT01488994|Secondary|Pharmacokinetics (PK): Total Area Under the Plasma Concentration Versus Time Curve From 0 to Infinity Post-infusion Per Dose (Total AUC/Dose)||Within 30 mins pre-infusion and 4 post-infusion timepoints. Refer to Population Description below for more details.|"All participants randomized to 2 groups:
Group 1 - BAX326 infusion in the morning PK timepoints: Pre-infusion and post-infusion at 15-30 minutes, then 7, 28 and 52 hours Group 2 - BAX326 infusion in the afternoon PK timepoints: Pre-infusion and post-infusion of 15-30 minutes, then 4, 24 and 69 hours"||IU*hour (hr)/dL||Standard Deviation|Mean
856347|NCT01488994|Secondary|Pharmacokinetics (PK): Total Area Under the Plasma Concentration Versus Time Curve From 0 to 72 Hours Post-infusion Per Dose (AUC 0-72h/Dose)||Within 30 mins pre-infusion and 4 post-infusion timepoints|On completion of the study, prospective changes to the planned statistical analysis were made not to analyze AUC 0-72h due to the different time points for the last PK blood sample. Only total AUC [i.e. AUC 0-infinity] was included in the PK analysis.|||||
856348|NCT01488994|Primary|Adverse Events (AEs) Possibly or Probably Related to BAX326||Throughout study period (approximately 17 months)|Full analysis set||AEs considered related to BAX326|||Number
856349|NCT01485796|Secondary|Number of Weeks to Reach Final 3 or 4-week Dose Interval|Non-parametric descriptive statistics (median, range) are provided.|7 months (per subject)|Of 36 participants treated with study drug in Epoch 2, 6 reached a final dose interval of 3 weeks and 30 reached a final dose interval of 4 weeks.||weeks||Full Range|Median
856350|NCT01485796|Secondary|Maximum Infusion Rate in Epoch 1 and Epoch 2|Non-parametric descriptive statistics (median, range) are provided.|7 months (per subject)|The number of participants analyzed for Epoch 1 is 37, as 37 participants were treated with study drug in Epoch 1. The number of participants analyzed for Epoch 2 is 36, as 36 participants were treated with study drug in Epoch 2.||mL/h||Full Range|Median
856351|NCT01485796|Secondary|Duration of Infusion in Epoch 1 and Epoch 2|Non-parametric descriptive statistics (median, range) are provided.|7 months (per subject)|The number of participants analyzed for Epoch 1 is 37, as 37 participants were treated with study drug in Epoch 1. The number of participants analyzed for Epoch 2 is 36, as 36 participants were treated with study drug in Epoch 2.||hours||Full Range|Median
856352|NCT01485796|Secondary|Number of Infusion Sites (Needle Sticks) Per Month in Epoch 1 and Epoch 2|Non-parametric descriptive statistics (median, range) are provided.|7 months (per subject)|The number of participants analyzed for Epoch 1 is 37, as 37 participants were treated with study drug in Epoch 1. The number of participants analyzed for Epoch 2 is 36, as 36 participants were treated with study drug in Epoch 2.||infusion sites (needle sticks)||Full Range|Median
856353|NCT01485796|Secondary|Number of Infusions Per Month in Epoch 1 and Epoch 2|Non-parametric descriptive statistics (median, range) are provided.|7 months (per subject)|The number of participants analyzed for Epoch 1 is 37, as 37 participants were treated with study drug in Epoch 1. The number of participants analyzed for Epoch 2 is 36, as 36 participants were treated with study drug in Epoch 2.||infusions||Full Range|Median
856354|NCT01485796|Secondary|Trough Levels of Immunoglobulin G (IgG)|IgG trough levels at the beginning of Study Epoch 1 (previous immunoglobulin treatment) and at the end of Study Epoch 2 were analyzed.|7 months (per subject)|At screening, data (ie, IgG trough levels) were available for analysis from 36 participants. At the end of Epoch 2, data were available for analysis from only 33 participants.||g/L||95% Confidence Interval|Geometric Mean
856355|NCT01485796|Secondary|Number of Subjects Who Develop Neutralizing Antibodies to rHuPH20||7 months (per subject)|||subjects|||Number
856356|NCT01485796|Secondary|Rate of All Adverse Events (Excluding Infections) Per Infusion|A point estimate and 95% confidence interval for the rate of adverse events per infusion was derived using a Poisson model.|7 months (per subject)|||adverse events||95% Confidence Interval|Number
856357|NCT01485796|Secondary|Number of All Related Adverse Events (Excluding Infections)||7 months (per subject)|||adverse events|||Number
856517|NCT01218438|Secondary|Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 72 Hours of Completion of Infusion Per Participant|Number of AEs that begin during or within 72 hours of completion of infusion divided by number of participants|Within 72 hours of completion of infusion|Safety Analysis Set||Adverse events per participant|||Number
856409|NCT01345669|Secondary|Health Related Quality of Life (HRQOL) Scores Over Time|HRQoL questionnaires focused on 3 scales: Pain scale from H&N35, Swallowing scale from H&N35 and Global health status/QoL scale from C30. Scoring of the symptom scales/items followed the European Organisation for Research and Treatment of Cancer (EORTC) scoring manual and a linear transformation of the scores to a 0-100 point scale. Higher values are better.|Baseline and 5 years|Randomised Set (RS): Included all patients who were randomised, regardless of taking investigational treatment (as randomised)||Unit on Scale||Standard Error|Least Squares Mean
856407|NCT01390389|Secondary|To Determine Effects of CoQ 10 on Bioenergetics (PCr and Beta NTP) in Older Adults With Bipolar Depression.|Changes in PCr and beta NTP will be demonstrated in Geri BD group challenged with CoQ10.|4-week trial|Healthy controls with no evidence of current or past psychiatric disorders, and subjects with Bipolar disorder who received CoQ10 therapy for 4 weeks. Subjects in the CoQ10 group started at 400 mg of CoQ10 a day, and increased to 800 mg a day at 2 weeks.||Integration Expressed as Arbitrary Unit||Standard Error|Least Squares Mean
856408|NCT01390389|Primary|Mean Concentrations of Cerebral Energetic Metabolites in Geriatric BPD and Older Controls at Baseline|Tissue-specific (gray or white matter) concentrations of of Phosphocreatine (PCr), Beta-Nucleoside Triphosphate (bNTP), and Inorganic Phosphate (Pi) in geriatric BPD compared with healthy controls at baseline. Concentrations were measured using CSI P MRS scan at 4T. The analysis of signal intensity is done through integration of the area under the curve and is expressed in arbitrary units.|Baseline|||Integration Expressed as Arbitrary Unit||Standard Error|Mean
856518|NCT01218438|Secondary|Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Regardless of Relationship to the Investigational Product Per Infusion|Number of all SAEs and AEs divided by number of infusions|Up to 20 months per subject (throughout entire study)||08/2017||||
856410|NCT01345669|Secondary|Time to Deterioration in Health Related Quality of Life (HRQOL)|HRQoL questionnaires focused on 3 scales: Pain scale from H&N35, Swallowing scale from H&N35 and Global health status/QoL scale from C30. Time to deterioration was defined as the time from randomisation to the first 10-point worsening on the 0-100 point scale. Patients with no deterioration (including those with disease recurrence/SPT) were censored at the last available HRQoL assessment date. Patients with no post-baseline assessments were censored on the day of randomisation.|Up to 5 years|Randomised Set (RS): Included all patients who were randomised, regardless of taking investigational treatment (as randomised)||Months||Inter-Quartile Range|Median
856411|NCT01345669|Secondary|Patients With Improved Health Related Quality of Life (HRQOL)|HRQoL questionnaires focused on 3 scales: Pain scale from H&N35, Swallowing scale from H&N35 and Global health status/QoL scale from C30. Improvement was defined as a score that improved from baseline by at least 10 points (on the 0-100 point scale) at any time during the study. If a patient had not improved, worsening was defined as a 10-point worsening at any time during the study. Patients who had neither improved nor worsened were considered as stable. Percentages of patients with improvement in HRQoL are presented.|Up to 5 years|Randomised Set (RS): Included all patients who were randomised, regardless of taking investigational treatment (as randomised)||Percentage of Patients|||Number
856412|NCT01345669|Secondary|Percentage of Patient Deaths (Overall Survival (OS))|Overall survival (OS), defined as the time from randomisation until death (regardless of cause). Due to the small event rate in both treatment arms caused by the early termination of the trial, the hazard estimate is not interpretable. Hence presented the total randomized and the percentage of patients died.|Up to 5 years|Randomised Set (RS): Included all patients who were randomised, regardless of taking investigational treatment (as randomised)||Percentage of patients|||Number
856413|NCT01345669|Secondary|Disease Free Survival (DFS) Rate at 2 Years|Disease Free Survival (DFS) rate at 2 years. Probability of being disease free at 2 years in percentage is provided based on Kaplan-Meier method.|Up to 2 years|Randomised Set (RS); ‘Overall number of participants analyzed’ are the number of patients at risk.||Probability (%)||95% Confidence Interval|Number
856414|NCT01345669|Primary|Disease Free Survival (DFS)|Disease Free Survival defined as the time from randomisation until documented tumour recurrence/ second primary tumour (SPT) or death from any cause, whichever occurred first.|Up to 5 years|Randomised Set (RS): Included all patients who were randomised, regardless of taking investigational treatment (as randomised)||Months||Inter-Quartile Range|Median
856415|NCT01308567|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P):Trial Outcome Index (TOI) as a Measure of HRQoL|FACT-P was a 39-item participant rated questionnaire that measures the concerns of participants with prostate cancer. It consisted of 5 sub-scales assessing physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and prostate-specific concerns (12 items). Physical well being, functional well being, and prostate-specific concerns sub-scales of the FACT-P questionnaire were combined to calculate TOI. Total TOI score ranges from 0 to 104, with higher scores representing a better quality of life with fewer symptoms.|Baseline, Day 1 of each cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 (each cycle 21-day); post-treatment follow up 1, 2, 3, 4, 5, 6 (each up to 12 weeks)|Analysis was performed on FACT-P population that included all participants with evaluable individual FACT-P subscale score at baseline and post-baseline on at least 1 of the subscale domains.||units on a scale||95% Confidence Interval|Least Squares Mean
856416|NCT01308567|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Total Score as a Measure of Health Related Quality of Life (HRQoL)|FACT-P was a 39-item participant rated questionnaire that measures the concerns of participants with prostate cancer. It consisted of 5 sub-scales assessing physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and prostate-specific concerns (12 items). FACT-P total score was the sum of all 5 subscale scores. It ranged from 0 to156 with higher score indicated better quality of life with fewer symptoms.|Baseline, Day 1 of each cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 (each cycle 21-day); post-treatment follow up 1, 2, 3, 4, 5, 6 (each up to 12 weeks)|Analysis was performed on FACT-P population that included all participants with evaluable individual FACT-P subscale score at baseline and post-baseline on at least 1 of the subscale domains.||units on a scale||95% Confidence Interval|Least Squares Mean
856417|NCT01308567|Secondary|Skeletal Related Events (SRE) Free Survival|SRE free survival was defined as the time interval between the date of randomization and the date of the occurrence of the first event defining a SRE or death due to any cause, whichever was earlier. SRE were assessed by clinical evaluation. Occurrence of SRE was defined as: pathological fracture(s) and/or spinal cord compression; need for bone irradiation, including radioisotopes or bone surgery; and change of antineoplastic therapy (including introduction of bisphosphonates or denosumab in the setting of increased pain) to treat bone pain. Analysis was performed by Kaplan-Meier method.|Baseline until occurrence of first SRE or death (maximum duration: 51 months)|Analysis was performed on ITT population which included all randomized participants.||months||95% Confidence Interval|Median
856418|NCT01308567|Secondary|Percentage of Participants With Pain Response|Pain response was defined as either a ≥2-point decrease from baseline median PPI score without increase in analgesic score, or a ≥50% decrease in analgesic use from baseline mean analgesic score (only in participants with baseline mean analgesic score≥10) without increase in the pain. Either criterion was maintained for 2 consecutive evaluations at least 3 weeks apart. PPI was rated by participant in a diary using a scale of 0=no pain, 1=mild, 2=discomforting, 3=distressing, 4=horrible 5=excruciating. Analgesic use was recorded by the participant in a diary. Analgesic score was calculated from the analgesic use data based on a table of analgesic medications, with non-narcotic medications assigned a value of 1 point and narcotic medications assigned a value of 4 points.|Baseline until pain progression, death or study cut-off date (maximum duration: 51 months)|Analysis was performed on ITT population. Number of participants analyzed=participants with pain score with median PPI ≥2 and/or mean analgesic score≥10 points at baseline and at least one valid post-baseline value for specified outcome measure.||percentage of participants||95% Confidence Interval|Number
856430|NCT01305213|Secondary|Incidence of Adverse Events (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 4.0|Toxicities will be characterized by their frequency and severity. Differences in the level of toxicities by treatment regimen will be assessed by classifying them as severe or not severe and examining the relative proportion of severe toxicities.|Up to 5 years|All eligible and treated patients||Participants|||Count of Participants
856419|NCT01308567|Secondary|Time to Pain Progression Free Survival (Pain PFS)|Time to pain PFS was defined as the time interval between date of randomization and the date of the first occurrence of pain progression or death, whichever was earlier. Pain progression was defined as an increase of ≥1 point in the median present pain intensity (PPI) score from the nadir confirmed by a second assessment at least 3 weeks later or ≥25 % increase in the mean analgesic score from baseline, due to cancer related pain confirmed by a second assessment at least 3 weeks later or requirement for local palliative radiotherapy. PPI was rated by participant in a diary using a scale of 0=no pain, 1=mild, 2=discomforting, 3=distressing, 4=horrible 5=excruciating. Analgesic use was recorded by the participant in a diary. Analgesic score was calculated from the analgesic use data based on a table of analgesic medications, with non-narcotic medications assigned a value of 1 point and narcotic medications assigned a value of 4 points. Analysis was performed by Kaplan-Meier method.|Baseline until disease progression, death or study cut-off date (maximum duration: 51 months)|Analysis was performed on ITT population which included all randomized participants.||months||95% Confidence Interval|Median
856420|NCT01308567|Secondary|Percentage of Participants With PSA Response|PSA response was defined as ≥50% decrease from baseline in serum PSA levels, confirmed by a second PSA value at least 3 weeks later in participants with baseline PSA value ≥10 ng/mL.|Baseline up to PSA progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 51 months)|Analysis was performed on ITT population. Number of participants analyzed=participants with PSA value ≥10 ng/mL at baseline and at least one valid post-baseline value for specified outcome measure.||percentage of participants||95% Confidence Interval|Number
856421|NCT01308567|Secondary|Time to Prostate Serum Antigen Progression Free Survival (PSA-PFS)|Time to PSA-PFS: time interval between date of randomization & first occurrence of PSA progression/ death, whichever was earlier. PSA progression:1) In PSA responders(≥50% decline from baseline PSA of ≥10 ng/mL):increase of ≥25%(at least 2 ng/mL)over nadir value, confirmed by second PSA value at least 3 weeks later;2)In PSA non-responders(not achieved ≥50% decline from baseline PSA ≥10 ng/mL):increase of ≥25% (at least 2 ng/mL) over baseline value, confirmed by second PSA value at least 3 weeks later;3)In participants not eligible for PSA response(baseline PSA <10 ng/mL):(a)in participants with baseline PSA>0 ng/mL&<10 ng/mL: increase in PSA by 25% (at least 2 ng/mL) above baseline level, confirmed by second PSA value at least 3weeks apart;(b)in participants with baseline value=0ng/mL: a post baseline PSA value ≥2ng/mL.Early rise in PSA only indicated progression if it was associated with another sign of DP or if it continued beyond 12 weeks. Analysis performed by Kaplan-Meier method.|Baseline up to PSA progression or death due to any cause or study cut-off date, whichever was earlier ((maximum duration: 51 months)|Analysis was performed on ITT population which included all randomized participants.||months||95% Confidence Interval|Median
856422|NCT01308567|Secondary|Percentage of Participants With Overall Objective Tumor Response|Overall objective tumor response was defined as having a partial response (PR) or complete response (CR) according to the RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|Baseline up to DP or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 51 months)|Analysis was performed on ITT population. Number of participants analyzed=participants with measurable disease at baseline and at least one valid post-baseline value analyzed for specified outcome measure.||percentage of participants||95% Confidence Interval|Number
856423|NCT01308567|Secondary|Time to Tumor Progression Free Survival|Time to tumor progression free survival was defined as the time interval between randomization and the date of first occurrence of tumor progression (assessed using RECIST version 1.1) or death, whichever was earlier. Analysis was performed by Kaplan-Meier method.|Baseline up to tumor progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 51 months)|ITT population included all randomized participants.||months||95% Confidence Interval|Median
856424|NCT01308567|Secondary|Progression Free Survival (PFS)|PFS: time interval between date of randomization to date of first occurrence of any of following events: tumor progression according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1; Prostate Specific Antigen (PSA) progression; pain progression or death due to any cause. Analysis was performed by Kaplan-Meier method.|Baseline up to tumor progression, PSA progression, pain progression or death (maximum duration: 51 months)|ITT population included all randomized participants.||months||95% Confidence Interval|Median
856425|NCT01308567|Primary|Overall Survival (OS)|OS was defined as the time interval from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, survival time was censored at the last date participant was known to be alive, or at the cut-off date if the participant’s last contact was after the cut-off date. The study cut-off date for the final analysis of OS was the date when the 774th death had been observed. Analysis was performed by Kaplan-Meier method.|Baseline up to death or study cut-off date, whichever was earlier (maximum duration: 51 months)|ITT population included all randomized participants.||months||95% Confidence Interval|Median
856426|NCT01305213|Secondary|Response by CA-125|The effects of treatment on the proportion responding by CA125 will be examined.|Up to 5 years|||Percentage of Participants||95% Confidence Interval|Number
856427|NCT01305213|Secondary|Overall Survival (OS)|Differences between measurable versus non-measurable disease status on PFS and OS will be examined with plots of survival curves, estimates of quartiles and hazard ratios.|Up to 5 years|||months||90% Confidence Interval|Median
856428|NCT01305213|Secondary|Tumor Response|Complete and Partial Tumor Response by RECIST 1.0|for those patients whose disease can be evaluated by physical examination, response wa assessed prior to each 21 day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle, up to 5 years|Patients with measurable disease||percentage of participants||90% Confidence Interval|Number
856429|NCT01305213|Secondary|Measurable Disease by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria and Progression Free Survival (PFS)|Differences between measurable versus non-measurable disease status on PFS and OS will be examined with plots of survival curves, estimates of quartiles and hazard ratios.|Up to 5 years|||months||95% Confidence Interval|Median
856431|NCT01305213|Primary|Progression-free Survival (PFS)|The time from randomization until disease progression, death, or date of last contact. Endpoints are progression or death. Patients who are not observed with an endpoint are censored.|For those patients whose disease can be evaluated by physical examination, progression was assessed prior to each 21 day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle, up to 5 years|All intent to treat patients||months||95% Confidence Interval|Median
856498|NCT01218438|Secondary|Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older|The PCS is a summary scale of the dimensions physical functioning, role physical, bodily pain, and general health. The component score is normalized to a standard population. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both sub-scores and summary scores.|Up to 20 months (throughout entire study)|Safety Analysis Set participants aged 14 years and older with scores at each respective time point.||Scores on a scale||95% Confidence Interval|Median
856587|NCT01175213|Secondary|Number of Participants With AEs Related to Anti-rHuPH20 Titers||Throughout entire study period for 160603 (1 year 11 months) and 160902 (2 years 11 months)|All participants who had been exposed to recombinant human hyaluronidase (rHuPH20) in studies 160603 or 160902.||Number of participants|||Number
856494|NCT01218438|Secondary|Life Quality Index - 13 Years and Older|"For the age group 13 years and older the respondent will be the participant.
Each of the four domains has a separate score, each has a different range as follows:
Treatment Interference Score Range: 6-42, Therapy-related Problems Score Range: 4-28, Therapy Setting Score Range: 3-21, Cost Score Range: 2-14. Higher scores represent more satisfaction with various aspects of treatment."|Up to 20 months per subject (throughout entire study)|Safety Analysis Set - participants aged 13 years and older with data (scores) at relevant time points||Score on a scale||95% Confidence Interval|Median
856495|NCT01218438|Secondary|Life Quality Index - 2 to 12 Years Old|"For the age group 2 to 12 years the respondent will be a parent.
Each of the four domains has a separate score, each has a different range as follows:
Treatment Interference Score Range: 6-42, Therapy-related Problems Score Range: 4-28, Therapy Setting Score Range: 3-21, Cost Score Range: 2-14. Higher scores represent more satisfaction with various aspects of treatment."|Up to 20 months (throughout entire study)|Safety Analysis Set - participants aged 2-12 years old with data (scores) at relevant time points||Score on a scale||95% Confidence Interval|Median
856496|NCT01218438|Secondary|Treatment Satisfaction Questionnaire for Medication (TSQM) - 13 Years and Older|"TSQM; for the age group 13 years and older the observer will be the participant.
Treatment Satisfaction Questionnaire for Medication (TSQM) is a global satisfaction scale used to assess the overall level of participant’s satisfaction or dissatisfaction with their medications. The following 3 domain were included: effectiveness, convenience, and global satisfaction.
The score of each of the 3 domains is based on an algorithm to create a score of 0 to 100. Higher score indicated greater satisfaction in that domain."|Up to 20 months per subject (throughout entire study)|Safety Analysis Set - participants aged 13 years and older with data (scores) at relevant time points||Score on a scale||95% Confidence Interval|Median
856497|NCT01218438|Secondary|Treatment Satisfaction Questionnaire for Medication (TSQM) - 2 to 12 Years Old|"TSQM; for the age group 2 to 12 years the observer will be a parent.
Treatment Satisfaction Questionnaire for Medication (TSQM) is a global satisfaction scale used to assess the overall level of participant’s satisfaction or dissatisfaction with their medications. The following 3 domain were included: effectiveness, convenience, and global satisfaction.
The score of each of the 3 domains is based on an algorithm to create a score of 0 to 100. Higher score indicated greater satisfaction in that domain."|Up to 20 months per subject (throughout entire study)|Safety Analysis Set - participants aged 2-12 years old with data (scores) at relevant time points||Score on a scale||95% Confidence Interval|Median
856516|NCT01218438|Secondary|Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 72 Hours of Completion of Infusion Per Infusion|Number of AEs that begin during or within 72 hours of completion of infusion divided by the number of infusions|Within 72 hours of completion of infusion|Safety Analysis Set||Adverse events per infusion|Infusions||Number
856499|NCT01218438|Secondary|Quality of Life- PEDS-QL^TM (Observer: Participant) for the Age Group 8 to 13 Years of Age|The Peds-QL is a generic Health-Related Quality of Life (HR QoL) instrument designed specifically for a pediatric population. It captures the following domains: general health/activities, feelings/emotional, social functioning, school functioning. Higher scores indicate better quality of life (QoL) for all domains of the Peds-QL. This modular instrument uses a 5-point scale: from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. 4 dimensions (physical, emotional, social, & school functioning) are scored. 2 summary scores (Psychosocial Health Summary, and Physical Health Summary) are presented, along with a total score.|Up to 20 months (throughout entire study)|Safety Analysis Set participants aged 8 to 13 with scores at each respective time point.||Score on a scale||95% Confidence Interval|Median
856500|NCT01218438|Secondary|Quality of Life- Pediatric Quality of Life Inventory^TM (PEDS-QL^TM) (Observer: Parent) for the Age Group 2 to 7 Years|The Peds-QL is a generic Health-Related Quality of Life (HR QoL) instrument designed specifically for a pediatric population. It captures the following domains: general health/activities, feelings/emotional, social functioning, school functioning. Higher scores indicate better quality of life (QoL) for all domains of the Peds-QL. This modular instrument uses a 5-point scale: from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. 4 dimensions (physical, emotional, social, & school functioning) are scored. 2 summary scores (Psychosocial Health Summary, and Physical Health Summary) are presented, along with a total score.|Up to 20 months (throughout entire study)|Safety Analysis Set (subset of participants aged 2 to 7 years)||Score on a scale||95% Confidence Interval|Median
856501|NCT01218438|Secondary|Number of Participants With Laboratory Confirmed Hemolysis That Occurred Following Investigational Product Administration|Laboratory tests for confirmation of potential hemolysis include Coomb’s test, haptoglobin, free hemoglobin, reticulocyte count, lactate dehydrogenase (LDH), and urine hemosiderin.|Epoch 1: 3 week IV interval- weeks 0, 10. Epoch 1: 4 week IV interval- weeks 0, 9. Epoch 3: Subcutaneous (SC) week 9. Epoch 4: SC weeks 17, 18, 40|Safety Analysis Set||Participants|||Number
856502|NCT01218438|Secondary|Short Term Tolerance - Change in Body Temperature||Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion at first 3 infusions in Epoch 1 & 2||08/2017||||
856503|NCT01218438|Secondary|Short Term Tolerance - Change in Respiratory Rate||Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion at first 3 infusions in Epoch 1 & 2||08/2017||||
856504|NCT01218438|Secondary|Short Term Tolerance - Change in Heart Rate (Pulse)||Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion at first 3 infusions in Epoch 1 & 2||08/2017||||
856505|NCT01218438|Secondary|Short Term Tolerance - Change in Blood Pressure||Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion at first 3 infusions in Epoch 1 & 2||08/2017||||
856506|NCT01218438|Secondary|Percentage of Infusions Tolerated With Intravenous or Subcutaneous Administration|"An infusion will be deemed as tolerated unless one of the following occurs:
Any serious related AE(s)
Any non-serious local or systemic related AE(s) that prevent(s) completion of infusion
Any severe non-serious local or systemic related AE(s) that occur within 60 minutes of completion of the infusion"|Up to 20 months (throughout entire study)|Safety Analysis Set||Percent of infusions|Infusions||Number
856507|NCT01218438|Secondary|Percentage of Participants for Whom the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Due to Tolerability Concerns or AEs||Up to 20 months (throughout entire study)|Safety Analysis Set||Percent of participants|||Number
856508|NCT01218438|Secondary|Number of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Due to Tolerability Concerns or AEs||Up to 20 months (throughout entire study)|Safety Analysis Set||Infusions|Infusions||Number
856509|NCT01218438|Secondary|Percentage of Participants Reporting One or More Local Non-serious Adverse Events (Non-SAEs)||Up to 20 months (throughout entire study)|Safety Analysis Set||Percent of participants|||Number
856510|NCT01218438|Secondary|Percentage of Infusions Associated With One or More Local Non-serious Adverse Events (Non-SAEs)|The number of infusions associated with local non-SAEs divided by the total number of infusions.|Up to 20 months (throughout entire study)|Safety Analysis Set||Percent of infusions|Infusions||Number
856511|NCT01218438|Secondary|Causally Related and/or Temporally Associated Adverse Events (AEs) Per Infusion|"The total number of all AEs (including and excluding infections) that begin during infusion or within 72 hours of completion of an infusion (temporally associated) plus the total number of AEs (including and excluding infections) starting more than 72 hours following the completion of an infusion determined by the investigator to be at least possibly related to the study drug(related), divided by the total number of infusions"|Within 72 hours post infusion for Temporally Associated AEs; End of each Study Epoch (Epoch 1, Epoch 2, Epoch 3, and Epoch 4) for Causally Related AEs|Safety Analysis Set||Adverse events per infusion|Infusions||Number
856512|NCT01218438|Secondary|Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 1 Hour of Completion of Infusion|Number of AEs that begin during or within 1 hour of completion of infusion divided by number of infusions|Within 1 hour of completion of infusion|Safety Analysis Set||Adverse events per infusion|Infusions||Number
856513|NCT01218438|Secondary|Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 1 Hour of Completion of Infusion Per Participant|Number of AEs that begin during or within 1 hour of completion of infusion divided by number of participants|Within 1 hour of completion of infusion|Safety Analysis Set||Adverse events per participant|||Number
856514|NCT01218438|Secondary|Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 24 Hours of Completion of Infusion Per Infusion|Number of AEs that begin during or within 24 hours of completion of infusion divided by number of infusions|Within 24 hours of completion of infusion|Safety Analysis Set||Adverse events per infusion|Infusions||Number
856515|NCT01218438|Secondary|Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 24 Hours of Completion of Infusion Per Participant|Number of AEs that begin during or within 24 hours of completion of infusion divided by number of participants|Within 24 hours of completion of infusion|Safety Analysis Set||Adverse events per participant|||Number
856519|NCT01218438|Secondary|Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Regardless of Relationship to the Investigational Product Per Participant|Number of all SAEs and AEs divided by number of participants|Up to 20 months per subject (throughout entire study)|Safety Analysis Set||Adverse events per participant|||Number
856520|NCT01218438|Secondary|Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Deemed Related to the Investigational Product Per Infusion|Number of related SAEs and AEs divided by number of subjects and divided by number of infusions|Up to 20 months per subject (throughout entire study)|Safety Analysis Set||Adverse events per infusion|Infusions||Number
856521|NCT01218438|Secondary|Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Deemed Related to the Investigational Product Per Participant|Number of related SAEs and AEs divided by number of participants|Up to 20 months per subject (throughout entire study)|Safety Analysis Set||Adverse events per participant|||Number
856522|NCT01218438|Secondary|Correction Factor to Determine the Individually Adapted Dose in Study 170904 Epoch 4 (Dose Adjustment Table)|"There is a high degree of variability in catabolism of immunoglobulin G (IgG) between individuals.
To address this, trough levels immediately prior to the 9th weekly infusion in Epoch 3 were measured.
The ratio of the measured trough levels on subcutaneous (SC) (Epoch 3) and intravenous (IV) administration (Epoch1) were compared to the expected trough level determined in Epoch 2. This was used to determine the Individually Adapted Dose to be used in Epoch 4.
This was an interim study analysis."|29 weeks|Pharmacokinetics interim analysis set to determine the Individually Adapted Dose for Epoch 4||Correction factor|||Number
856523|NCT01218438|Secondary|Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Minimum Concentration (Cmin)|The minimum concentration (Cmax) following administration of study drug (either immune globulin administered intravenously (IGIV) or immune globulin administered subcutaneously (IGSC).|Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18|Safety Analysis Set - sub-groups with data at relevant time points||mg/L||95% Confidence Interval|Median
856524|NCT01218438|Secondary|Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Time to Maximum Concentration (Tmax)|The minimum time (Tmax) to reach the maximum concentration (Cmax)|Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18|Safety Analysis Set - sub-groups with data at relevant time points||Hours (s)||95% Confidence Interval|Geometric Mean
856525|NCT01218438|Secondary|Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Maximum Concentration (Cmax)|The maximum concentration (Cmax) following administration of study drug (either immune globulin administered intravenously (IGIV) or immune globulin administered subcutaneously (IGSC).|Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18|Safety Analysis Set - sub-groups with data at relevant time points||mg/L||95% Confidence Interval|Geometric Mean
856526|NCT01218438|Secondary|Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Clearance (CL) for Immune Globulin Administered Intravenously (IGIV) and Apparent Clearance (CL/F) for Immune Globulin Administered Subcutaneously|Clearance (CL) or apparent clearance (CL/F) for IV and SC administration, respectively, will be determined by the formula: CL or CL/F = (Dose (mg/kg)) / (AUC 0- τ). (F= bioavailability)|Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18|Safety Analysis Set - sub-groups with data at relevant time points||mL/kg/days||95% Confidence Interval|Geometric Mean
856527|NCT01218438|Secondary|Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Dose Per Weight-adjusted Area Under the Curve (AUC)|The AUC between adjacent infusions will be calculated by the trapezoidal rule . Linear interpolation/extrapolation will be used to calculate the AUC for exact duration of the infusion intervals (21 or 28 days for IV administration and 7 days for SC administration). To allow for comparisons between Epochs 1, 2 and 4, AUC 0-τ will be standardized for the infusion intervals (3 or 4 weeks vs. 1 week) adjusted for the dose per weight.|Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18|Safety Analysis Set - sub-groups with data at relevant time points||(mg*days/L)/(g/kg)||95% Confidence Interval|Geometric Mean
856528|NCT01218438|Secondary|Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Area Under the Curve (AUC)|The AUC between adjacent infusions will be calculated by the trapezoidal rule . Linear interpolation/extrapolation will be used to calculate the AUC for exact duration of the infusion intervals (21 or 28 days for IV administration and 7 days for SC administration). To allow for comparisons between Epochs 1, 2 and 4, AUC 0-τ will be standardized for the infusion intervals (3 or 4 weeks vs. 1 week )|Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18|Safety Analysis Set - sub-groups with data at relevant time points||mg*days/L||95% Confidence Interval|Geometric Mean
856529|NCT01218438|Secondary|Pharmacokinetics Parameters for Immunoglobulin G (IgG): Minimum Concentration (Cmin)|The minimum concentration (Cmax) following administration of study drug (either immune globulin administered intravenously (IGIV) or immune globulin administered subcutaneously (IGSC).|Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18|Safety Analysis Set - sub-groups with data at relevant time points||g/L||95% Confidence Interval|Geometric Mean
856530|NCT01218438|Secondary|Pharmacokinetics Parameters for Immunoglobulin G (IgG): Time to Maximum Concentration (Tmax)|The minimum time (Tmax) to reach the maximum concentration (Cmax)|Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18|Safety Analysis Set - sub-groups with data at relevant time points||hours (h)||95% Confidence Interval|Geometric Mean
856531|NCT01218438|Secondary|Pharmacokinetics Parameters for Immunoglobulin G (IgG): Maximum Concentration (Cmax)|The maximum concentration (Cmax) following administration of study drug (either immune globulin administered intravenously (IGIV) or immune globulin administered subcutaneously (IGSC).|Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18|Safety Analysis Set - sub-groups with data at relevant time points||g/L||95% Confidence Interval|Geometric Mean
856532|NCT01218438|Secondary|Pharmacokinetics Parameters for Immunoglobulin G (IgG): Clearance (CL) for Immune Globulin Administered Intravenously (IGIV) and Apparent Clearance for Immune Globulin Administered Subcutaneously (IGSC)|Clearance (CL) or apparent clearance (CL/F) for IV and SC administration, respectively, will be determined by the formula: CL or CL/F = (Dose (mg/kg)) / (AUC 0-τ). (F= bioavailability)|Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18|Safety Analysis Set - sub-groups with data at relevant time point||mL/kg/days||95% Confidence Interval|Geometric Mean
856533|NCT01218438|Secondary|Pharmacokinetics Parameters for Immunoglobulin G (IgG): Dose Per Weight-adjusted Area Under the Curve (AUC)|The AUC between adjacent infusions will be calculated by the trapezoidal rule. Linear interpolation/extrapolation will be used to calculate the AUC for exact duration of the infusion intervals (21 or 28 days for IV administration and 7 days for SC administration). To allow for comparisons between Epochs 1, 2 and 4, AUC0-τ will be standardized for the infusion intervals (3 or 4 weeks vs. 1 week) adjusted for the dose per weight.|Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18|Safety Analysis Set - sub-groups with data at relevant time points||(g*days/L)/(g/kg)||95% Confidence Interval|Geometric Mean
856534|NCT01218438|Secondary|Pharmacokinetics Parameters for Immunoglobulin G (IgG): Area Under the Curve (AUC)|The AUC between adjacent infusions will be calculated by the trapezoidal rule. Linear interpolation/extrapolation will be used to calculate the AUC for exact duration of the infusion intervals (21 or 28 days for IV administration and 7 days for SC administration). To allow for comparisons between Epochs 1, 2 and 4, AUC0-τ will be standardized for the infusion intervals (3 or 4 weeks vs. 1 week)|Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18|Safety Analysis Set - sub-groups with data at relevant time points||g*days/L||95% Confidence Interval|Geometric Mean
856535|NCT01218438|Secondary|Trough Levels of Anti-Hepatitis B Antibody||"Epoch 1: 3 week IV interval- weeks 1, 4, 7, 10, 13. Epoch 1: 4 week IV interval- weeks 1, 5, 9, 13. Epochs 2 & 3: Subcutaneous (SC) weeks 5, 9. Epoch 4: SC weeks 1, 9, 17, 29, 40 (week dependent on time to establish Adjusted Dose in Epoch 2)"|Safety Analysis Set - sub-groups with data at relevant time points||mIU/mL||95% Confidence Interval|Geometric Mean
856536|NCT01218438|Secondary|Trough Levels of Anti-Haemophilus Influenza B Antibody||"Epoch 1: 3 week IV interval- weeks 1, 4, 7, 10, 13. Epoch 1: 4 week IV interval- weeks 1, 5, 9, 13. Epochs 2 & 3: Subcutaneous (SC) weeks 5, 9. Epoch 4: SC weeks 1, 9, 17, 29, 40 (week dependent on time to establish Adjusted Dose in Epoch 2)"|Safety Analysis Set - sub-groups with data at relevant time points||mg/L||95% Confidence Interval|Geometric Mean
856537|NCT01218438|Secondary|Trough Levels of Anti-Tetanus Antibody||"Epoch 1: 3 week IV interval- weeks 1, 4, 7, 10, 13. Epoch 1: 4 week IV interval- weeks 1, 5, 9, 13. Epochs 2 & 3: Subcutaneous (SC) weeks 5, 9. Epoch 4: SC weeks 1, 9, 17, 29, 40 (week dependent on time to establish Adjusted Dose in Epoch 2)"|Safety Analysis Set - sub-groups with data at relevant time points||IU/mL||95% Confidence Interval|Geometric Mean
856538|NCT01218438|Secondary|Trough Levels of IgG (Total), and IgG Subclasses at the End of the Treatment Intervals||"Epoch 1: 3 week IV interval- weeks 0, 1, 4, 7, 10, 13. Epoch 1: 4 week IV interval- weeks 0, 1, 5, 9, 13. Epochs 2 & 3: Subcutaneous (SC) weeks 5, 9. Epoch 4: SC weeks 1, 9, 17, 29, 40 (week dependent on time to establish Adjusted Dose in Epoch 2)"|Safety Analysis Set - sub-groups with data at relevant time points||g/L||95% Confidence Interval|Geometric Mean
856539|NCT01218438|Secondary|Bioavailability of IGSC, 20% as Measured by the Ratio of the Geometric Means of Immunoglobulin G (IgG) AUCSC (Epoch 4) to IgG AUCIV,0-τ (Standardized to 1 Week) (Epoch 1) Adjusted for Dose and Dosing Frequency (Participants ≥12 Years Old)|"IGSC, 20% = Immune Globulin Subcutaneous (Human), 20% Solution;
AUCSC = area under the concentration-time curve following subcutaneous administration;
AUCIV,0-τ = area under the concentration-time curve following intravenous administration over a dosing interval"|Epoch 1: 3 week IV administration interval: Week 10, 11, 12, 13. Epoch 1: 4 week IV interval: Week 9, 10, 11, 12, 13. Epoch 4 Subcutaneous administration weeks 17, 18|Safety Analysis Set with correctly administered IGIV 10% dose in Epoch 1||Ratio||90% Confidence Interval|Geometric Mean
856540|NCT01218438|Secondary|Annual Rate of Acute (Urgent or Unscheduled) Physician Visits, or Visits to the Emergency Room for Illness or Infection Per Participant||1 year|Safety Analysis Set||Estimated visits/participant||95% Confidence Interval|Number
856541|NCT01218438|Secondary|Annual Rate of Days of Hospitalizations for Illness or Infection Per Participant||1 year|Safety Analysis Set||Estimated days/participant||95% Confidence Interval|Number
856542|NCT01218438|Secondary|Annual Rate of Hospitalizations for Illness or Infection Per Participant||1 year|Safety Analysis Set||Estimated hospitalizations/participant||95% Confidence Interval|Number
856543|NCT01218438|Secondary|Annual Rate of Days on Antibiotics Per Participant||1 year|Safety Analysis Set||Estimated days/particpant||95% Confidence Interval|Number
856544|NCT01218438|Secondary|Annual Rate of Days Off School/Work or Days Unable to Perform Normal Daily Activities Due to Illness or Infection Per Participant||1 year|Safety Analysis Set||Estimated days off/participant||95% Confidence Interval|Number
856545|NCT01218438|Secondary|Annual Rate of Fever Episodes Per Participant||1 year|Safety Analysis Set||Estimated episodes/year||95% Confidence Interval|Number
856546|NCT01218438|Secondary|Annual Rate of Sinus Infections Per Participant||1 year|Safety Analysis Set||Estimated infections/year||99% Confidence Interval|Number
856547|NCT01218438|Secondary|Annual Rate of All Infections Per Participant||1 year|Safety Analysis Set||Estimated infections/year||95% Confidence Interval|Number
856548|NCT01218438|Primary|Rate of Acute Serious Bacterial Infections Per Year (ASBI)|"Annual rate of validated acute serious bacterial infections was calculated using a Poisson model to account for the different lengths of observation per participant.
The observation period for each participant starts with the day of the first subcutaneous (SC) infusion in Study Epoch 2 and ends with the day of the End of Study visit."|1 year|Safety Analysis Set||Estimated infections/ year|||Number
856554|NCT01178294|Secondary|Number of Participants Who Developed an Anti-host Cell Protein Baby Hamster Kidney (BHK) Antibody Titer||Through 90 days ± 7 days following final OBI-1 dose|21 subjects in the ITT population (n=29) with available baseline and follow-up test results||participants|||Number
856555|NCT01178294|Secondary|Number of Participants Who Developed de Novo Anti-OBI-1 Antibody Titers||Through 90 days ± 7 days following final OBI-1 dose|28 eligible subjects with acquired hemophilia A in the ITT population (n=29), of whom 18 had no detectable anti-porcine FVIII inhibitor titers at baseline (<0.6 BU) and 10 had detectable anti-porcine FVIII antibody titers at baseline (>=0.6 BU)||participants|||Number
856556|NCT01178294|Other Pre-specified|Anti-human Factor VIII Antibody Titer||Through 90 days ± 7 days following final OBI-1 dose|Anti-human factor VIII antibody titer data were presented in subject data listings. No statistical test was planned for anti-human factor VIII antibody titer.|||||
856557|NCT01178294|Secondary|PK Analysis- Terminal Half-life|Participation in the PK sampling was optional. PK parameters obtained from the non-bleeding state were summarized with descriptive statistics. Half-life was calculated as the time it took to reduce percent activity by half.|Pre-infusion 15-20 minutes, Post-infusion 1, 3, 6, 12, 18, 24 hours|PK population||hours||Standard Deviation|Mean
856558|NCT01178294|Secondary|PK Analysis- Area Under the Concentration-time Curve (AUC) From Time 0 to the Last Measurable Concentration|Participation in the PK sampling was optional. PK parameters obtained from the non-bleeding state were summarized with descriptive statistics. AUC was calculated as area under the percent activity-time curve.|Pre-infusion 15-20 minutes, Post-infusion 1, 3, 6, 12, 18, 24 hours|PK population||percent activity*hours||Standard Deviation|Mean
856559|NCT01178294|Secondary|PK Analysis- Volume of Distribution (Vd) at Steady State|Participation in the PK sampling was optional. PK parameters obtained from the non-bleeding state were summarized with descriptive statistics.|Pre-infusion 15-20 minutes, Post-infusion 1, 3, 6, 12, 18, 24 hours|PK population||U/percent activity||Standard Deviation|Mean
856560|NCT01178294|Secondary|Pharmacokinetics (PK) Analysis- Plasma Clearance|Participation in the PK sampling was optional. PK parameters obtained from the non-bleeding state were summarized with descriptive statistics.|Pre-infusion 15-20 minutes, Post-infusion 1, 3, 6, 12, 18, 24 hours|PK population (= all subjects in the ITT population who consent to PK draws and have factor VIII levels measured at the central reference laboratory)||U/(percent activity*hours)||Standard Deviation|Mean
856561|NCT01178294|Secondary|Correlation Between the Pre-infusion Anti-OBI-1 Antibody Titers, the Total Dose of OBI-1, the Outcome at 24 Hours and the Eventual Control of the Bleeding Episode||Through 90 days ± 7 days following final OBI-1 dose|Because of expected sparseness of positive anti-OBI-1 antibody titers, formal statistical analyses of correlation were not performed.|||||
856562|NCT01178294|Secondary|Correlation Between Response to OBI-1 Therapy at Specified Time Points and Eventual Control of Serious Bleeding Episodes at 24 Hours||24 hours|29 subjects (ITT population) had responses available at 24 hours after initial infusion of OBI-1.||participants with bleeds controlled|||Number
856563|NCT01178294|Secondary|Correlation Between Response to OBI-1 Therapy at 16 Hours and Eventual Control of Serious Bleeding Episodes at 24 Hours||24 hours|All 19 subjects in the ITT population (n=29) who had responses available at 16 hours after initial infusion of OBI-1 had a positive response.||subjects with eventual bleed control|||Number
856564|NCT01178294|Secondary|Correlation Between Positive Response to OBI-1 Therapy at 8 Hours and Eventual Control of Serious Bleeding Episodes at 24 Hours||24 hours|Of 21 subjects in the ITT population (n=29) with responses available at 8 hours after initial infusion of OBI-1, 20 had a positive response.||subjects with eventual bleed control|||Number
856565|NCT01178294|Secondary|Total Number of Infusions of OBI-1 Required to Successfully Control 'Qualifying' Bleeding Episodes|'Qualifying bleeding episode' was defined as the 'initial, serious bleeding episode'. A serious bleeding episode was considered 'successfully controlled' if the investigator had checked 'completed OBI-1 therapy as treatment success' on the eCRF.|Time of successful control of qualifying bleeding episode (varied from participant to participant)|The analysis was performed in 25 of 29 participants in the ITT population whose 'qualifying' bleeding episode was controlled successfully.||infusions per participant||Standard Deviation|Mean
856566|NCT01178294|Secondary|Total Dose of OBI-1 Required to Successfully Control 'Qualifying' Bleeding Episodes|'Qualifying bleeding episode' was defined as the 'initial, serious bleeding episode'.|Time of successful control of qualifying bleeding episode (varied from participant to participant)|The analysis was performed in 25 of 29 participants in the ITT population whose 'qualifying' bleeding episode was controlled successfully.||dose in U/kg||Standard Deviation|Mean
856567|NCT01178294|Secondary|Frequency of Infusions of OBI-1 Required to Successfully Control Qualifying Bleeding Episodes|'Frequency of infusions' was calculated as the 'average number of infusions per day'. 'Qualifying bleeding episode' was defined as the 'initial, serious bleeding episode'.|Time of successful control of qualifying bleeding episode (varied from participant to participant)|The analysis was performed in 25 of 29 participants in the ITT population whose 'qualifying' bleeding episode was controlled successfully.||average number of infusions per day||Standard Deviation|Mean
856568|NCT01178294|Secondary|Percentage of Serious Bleeding Episodes Responsive to OBI-1 Therapy at Designated Assessment Time Points After the Initiation of Therapy, as Assessed by the Investigator|A 'positive response' is defined as 'effective' (bleeding stopped with clinical control and FVIII levels of 50% or higher ) or 'partially effective' (bleeding reduced with clinical stabilization and FVIII levels of 20% or higher) control of bleeding, as determined by the investigator using a 4-point rating scale (effective - partially effective - poorly effective - not effective). 'Poorly effective' is defined as 'bleeding slightly reduced or unchanged and FVIII levels of less than 50%'. 'Not effective' is defined as 'bleeding worsening and FVIII levels of less than 50%'.|16 hours|19 subjects of the ITT population (n=29) had responses available at 16 hours after initial infusion of OBI-1.||percentage of serious bleeding episodes|Responses Available at 16 hrs|95% Confidence Interval|Number
856569|NCT01178294|Secondary|Percentage of Serious Bleeding Episodes Responsive to OBI-1 Therapy at Designated Assessment Time Points After the Initiation of Therapy, as Assessed by the Investigator|A 'positive response' is defined as 'effective' (bleeding stopped with clinical control and FVIII levels of 50% or higher ) or 'partially effective' (bleeding reduced with clinical stabilization and FVIII levels of 20% or higher) control of bleeding, as determined by the investigator using a 4-point rating scale (effective - partially effective - poorly effective - not effective). 'Poorly effective' is defined as 'bleeding slightly reduced or unchanged and FVIII levels of less than 50%'. 'Not effective' is defined as 'bleeding worsening and FVIII levels of less than 50%'.|8 hours|21 subjects of the ITT population (n=29) had responses available at 8 hours after initial infusion of OBI-1.||percentage of serious bleeding episodes|Responses Available at 8 hrs|95% Confidence Interval|Number
856570|NCT01178294|Secondary|Overall Percentage of Serious Bleeding Episodes Successfully Controlled With OBI-1 Therapy, as Assessed by the Investigator|Treatment success was defined as control of qualifying bleeding episode at the time of final treatment dosing. A serious bleeding episode was considered 'successfully controlled' if the investigator had checked 'completed OBI-1 therapy as treatment success' on the eCRF.|At the time of final treatment dosing (varied from participant to participant depending on bleeding episodes)|ITT population = 29 subjects with initial serious bleeding episodes (BEs)||percentage of serious bleeding episodes|Initial Serious Bleeding Episodes|95% Confidence Interval|Number
856571|NCT01178294|Primary|Percentage of Serious Bleeding Episodes Responsive to OBI-1|"The initial serious (qualifying) bleeding episode for each subject was analyzed for the primary efficacy outcome measure. A 'positive response' is defined as 'effective' (bleeding stopped with clinical control and FVIII levels of 50% or higher ) or 'partially effective' (bleeding reduced with clinical stabilization and FVIII levels of 20% or higher) control of bleeding, as determined by the investigator using a 4-point rating scale (effective - partially effective - poorly effective - not effective). 'Poorly effective' is defined as 'bleeding slightly reduced or unchanged and FVIII levels of less than 50%'. 'Not effective' is defined as 'bleeding worsening and FVIII levels of less than 50%'."|24 hours after initiation of treatment|Intent to Treat (ITT) population = 29 subjects with initial serious bleeding episodes||percentage of serious bleeding episodes|Initial Serious Bleeding Episodes|95% Confidence Interval|Number
856572|NCT01175213|Secondary|Percentage of Infusions Associated With One or More Local AEs (Including and Excluding Infections), at Any Time During the Study||Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.|Safety Analysis Set||Percentage of infusions|Infusions||Number
856573|NCT01175213|Secondary|Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion|"Categories presented as adverse event (AE) type : Total, Local, Systemic including infections, Systemic excluding infections, Seriousness: Serious AE (SAE), non-serious AE (non-SAE) and Severity (Mild, Moderate, Severe, Total).
All of these adverse events are non-serious AEs."|Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.|Safety Analysis Data Set||Number of AEs per infusion|Infusions||Number
856574|NCT01175213|Secondary|Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion|"Categories presented as adverse event (AE) type : Total, Local, Systemic including infections, Systemic excluding infections, Seriousness: Serious AE (SAE), non-serious AE (nsAE) and Severity (Mild, Moderate, Severe, Total).
All of these adverse events are non-serious AEs."|Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.|Safety Analysis Data Set||Number of AEs per participant|||Number
856575|NCT01175213|Secondary|Rate of AEs Per Infusion (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (“Related”)|"Categories presented as adverse event (AE) type : Total, Local, Systemic including infections, Systemic excluding infections, and Severity (Mild, Moderate, Severe, Total).
All of these adverse events are non-serious AEs."|Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.|Safety Analysis Data Set||Number of AEs per infusion|Infusions||Number
856576|NCT01175213|Secondary|Rate of AEs Per Participant (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (“Related”)|"Categories presented as adverse event (AE) type : Total, Local, Systemic including infections, Systemic excluding infections, and Severity (Mild, Moderate, Severe, Total).
All of these adverse events are non-serious AEs."|Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.|Safety Analysis Data Set||Number of AEs per participant|||Number
856577|NCT01175213|Secondary|Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z).|"Categories presented as Preferred term-Seriousness-Severity. The following codes are to be used:
Seriousness: non-SAE-non-serious AE; SAE-serious AE Severity: Mild; Mod (Moderate); Sev (Severe)"|Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.|Safety Analysis Data Set||Number of AEs per infusion|Infusions||Number
856578|NCT01175213|Secondary|Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M).|"Categories presented as Preferred term-Seriousness-Severity. The following codes are to be used:
Seriousness: non-SAE-non-serious AE; SAE-serious AE Severity: Mild; Mod (Moderate); Sev (Severe)"|Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.|Safety Analysis Data Set||Number of AEs per infusion|Infusions||Number
856579|NCT01175213|Secondary|Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F).|"Categories presented as Preferred term-Seriousness-Severity. The following codes are to be used:
Seriousness: non-SAE-non-serious adverse event; SAE- serious adverse event Severity: Mild; Mod (Moderate); Sev (Severe)
Preferred terms abbreviated:
ADHD - Attention Deficit/Hyperactivity Disorder COPD - Chronic Obstructive Pulmonary Disease
Other abbreviations:
Inc. - Increased Dis. - Disease"|Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.|Safety Analysis Data Set||Number of AEs per infusion|Infusions||Number
856580|NCT01175213|Secondary|Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z).|"Categories presented as Preferred term-Seriousness-Severity. The following codes are to be used:
Seriousness: non-SAE-non-serious AE; SAE-serious AE Severity: Mild; Mod (Moderate); Sev (Severe)"|Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.|Safety Analysis Data Set||Number of AEs per participant|||Number
856581|NCT01175213|Secondary|Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M).|"Categories presented as Preferred term-Seriousness-Severity. The following codes are to be used:
Seriousness: non-SAE-non-serious AE; SAE-serious AE Severity: Mild; Mod (Moderate); Sev (Severe)"|Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.|Safety Analysis Data Set||Number of AEs per participant|||Number
856582|NCT01175213|Secondary|Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F).|"Categories presented as Preferred Term-Seriousness-Severity. The following codes are to be used:
Seriousness: non-SAE-non-serious AE; SAE-serious AE Severity: Mild; Mod (Moderate); Sev (Severe)
Preferred terms abbreviated:
ADHD - Attention Deficit/Hyperactivity Disorder COPD - Chronic Obstructive Pulmonary Disease
Other abbreviations:
Inc. - Increased Dis. - Disease"|Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.|Safety Analysis Data Set||Number of AEs per participant|||Number
856583|NCT01175213|Secondary|Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z).|"Categories presented as Preferred Term-Seriousness, Relatedness, Severity. The following codes are to be used:
Seriousness: non-SAE-non-serious AE; SAE-serious AE Relatedness to study drug: R (related to either study drug); NR (not related to either or both study drugs). Study drugs are Immune Globulin Subcutaneous Solution, 10% (IGSC, 10%) and recombinant human hyaluronidase (rHuPH20) Severity: Mild; Mod (Moderate); Severe
Preferred terms abbreviated:
Infection - Inf."|Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.|Safety Analysis Data Set||Number of AEs|||Number
856584|NCT01175213|Secondary|Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M).|"Categories presented as Preferred Term-Seriousness-Relatedness-Severity. The following codes are to be used:
Seriousness: non-SAE-non-serious AE; SAE-serious AE Relatedness to study drug: R (related to either study drug); NR (not related to either or both study drugs). Study drugs are Immune Globulin Subcutaneous Solution, 10% (IGSC, 10%) and recombinant human hyaluronidase (rHuPH20) Severity: Mild; Mod (Moderate); Severe"|Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.|Safety Analysis Data Set||Number of AEs|||Number
856585|NCT01175213|Secondary|Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F).|"Categories presented as Preferred Term-Seriousness-Relatedness-Severity. The following codes are to be used:
Seriousness: non-SAE-non-serious AE; SAE-serious AE Relatedness to study drug: R (related to either study drug); NR (not related to either or both study drugs). Study drugs are Immune Globulin Subcutaneous Solution, 10% (IGSC, 10%) and recombinant human hyaluronidase (rHuPH20) Severity: Mild; Mod (Moderate); Severe
Preferred terms abbreviated:
ADHD - Attention Deficit/Hyperactivity Disorder COPD - Chronic Obstructive Pulmonary Disease
Other abbreviations:
CPK - Creatinine Phosphokinase Inc. - Increased Dis - Disease Sml- small"|Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.|Safety Analysis Data Set||Number of AEs|||Number
856586|NCT01175213|Secondary|Percentage of Participants With AEs Related to Anti-rHuPH20 Titers||Throughout entire study period for 160603 (1 year 11 months) and 160902 (2 years 11 months)|All participants who had been exposed to recombinant human hyaluronidase (rHuPH20) in studies 160603 or 160902.||Percentage of participants|||Number
856588|NCT01175213|Secondary|Percentage of Participants Who Develop Antibodies and Neutralizing Antibodies to rHuPH20|"Participants who develop binding antibodies and/or neutralizing antibodies to recombinant human hyaluronidase (rHuPH20) from study 160603 and/ or from this study (160902) are included here.
This study (160902) is an extension of study 160603. Study 160603 was divided into 2 study epochs. In epoch 1 of study 160603 participants were treated with intravenous (IV) administration of Immune Globulin Subcutaneous Solution (IGSC), 10%. In epoch 2 of study 160603 participants were treated with subcutaneous (SC) administration of IGSC, 10% after SC administration of rHuPH20. Only participants who completed study 160603 were eligible to be screened and enrolled in this study (160902).
In this study, participants started on same doses of IGSC, 10% and rHuPH20 that were used for the last infusions in epoch 2 of study 160603."|Throughout entire study period for 160603 (1 year 11 months) and 160902 (2 years 11 months)|Participants from study 160603 and this study (160902) who have received at least one infusion of rHuPH20||Percentage of participants|||Number
856589|NCT01175213|Secondary|Number of Participants Who Develop Antibodies and Neutralizing Antibodies to rHuPH20|"Participants who develop binding antibodies and/or neutralizing antibodies to recombinant human hyaluronidase (rHuPH20) from study 160603 and/ or from this study (160902) are included here.
This study (160902) is an extension of study 160603. Study 160603 was divided into 2 study epochs. In epoch 1 of study 160603 participants were treated with intravenous (IV) administration of Immune Globulin Subcutaneous Solution (IGSC), 10%. In epoch 2 of study 160603 participants were treated with subcutaneous (SC) administration of IGSC, 10% after SC administration of rHuPH20. Only participants who completed study 160603 were eligible to be screened and enrolled in this study (160902).
In this study, participants started on same doses of IGSC, 10% and rHuPH20 that were used for the last infusions in epoch 2 of study 160603."|Throughout entire study period for 160603 (1 year 11 months) and 160902 (2 years 11 months)|Participants from study 160603 and this study (160902) who have received at least one infusion of rHuPH20||Number of participants|||Number
856590|NCT01175213|Secondary|Percentage of Infusions Associated With One or More Moderate or Severe AEs (Including and Excluding Infections) That Begin During or Within 72 Hours of Completion of an Infusion||Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.|Safety Analysis Set||Percentage of infusions|Infusions||Number
856591|NCT01175213|Secondary|Percentage of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Interrupted or Stopped for Tolerability Concerns or for AEs||Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.|Safety Analysis Set||Percentage of infusions|Infusions||Number
856592|NCT01175213|Secondary|The Annual Rate of Serious Adverse Events (SAEs), Related and Not Related to Study Drugs|"Separated into age groups as described below and into related (related to either study drug) and not related (not related to either or both study drugs).
Study drugs are Immune Globulin Subcutaneous Solution (IGSC), 10% and recombinant human hyaluronidase (rHuPH20)."|Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.|Safety Analysis Set||SAEs/year|||Number
856593|NCT01175213|Primary|Trough Levels of IgG Maintained During the Study Period in Relation to Dose Frequency|"Immunoglobulin (IgG) steady state trough levels were measured in relation to dose frequency by measuring in relation to treatment interval (2-, 3- or 4-week intervals).
Initially participants were administered subcutaneous (SC) infusions of Immune Globulin Subcutaneous Solution (IGSC), 10%, after SC administration of human recombinant hyaluronidase (rHuPH20) [or IV infusions of IGSC, 10% only] at the treatment intervals and dose determined by epoch 2 of study 160603 (3- or 4-week intervals).
After 3 treatment intervals (either 3- or 4- week intervals), participants changed to a 2-week treatment interval, if agreed with participant and investigator, with the dose adjusted to 1/2 of the 4-week dose or 2/3 of the 3-week dose, whichever was applicable. The rHuPH20 dose was adjusted relative to the new IGSC, 10% dose in order to achieve a dose ratio of 75 U/g IgG.
This efficacy outcome measure was only applicable prior to the safety follow-up i.e. before discontinuation of rHuPH20."|Throughout the efficacy period only (from 60 to 729 days)|Safety Analysis Set||g/L||95% Confidence Interval|Median
856594|NCT01175213|Primary|Annual Rate of All Infections|"Annualized rate of infections per participant as defined by MedDRA system organ class (SOC) infections and infestations.
The point estimate of the annual rate of all infections was provided during subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10%, after SC administration of human recombinant hyaluronidase (rHuPH20).
This efficacy outcome measure was only applicable prior to the safety follow-up i.e. before discontinuation of rHuPH20."|Throughout the efficacy period only (from 60 to 729 days)|Safety Analysis Set excluding the 3 participants who were treated with intravenous (IV) administration of IGSC, 10% without rHuPH20||Number of infections/year||95% Confidence Interval|Number
856595|NCT01175213|Primary|Annual Rate of Serious Bacterial Infections|"The point estimate of the annual rate of validated acute serious bacterial infections (VASBIs) per participant per year was provided during subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10%, after SC administration of human recombinant hyaluronidase (rHuPH20).
This efficacy outcome measure was only applicable prior to the safety follow-up i.e. before discontinuation of rHuPH20."|Throughout the efficacy period only (from 60 to 729 days)|Safety Analysis Set excluding the 3 participants who were treated with intravenous (IV) administration of IGSC, 10% without rHuPH20||Estimated infections/year|||Number
856596|NCT01162499|Secondary|Peak Glucagon Concentration During Infusion|To examine the effect of Exendin-(9-39) on plasma glucagon levels, samples were collected at various 3 hours after the start of the infusion. The mean peak glucagon concentration for both Exendin-(9-39) doses were compared with the peak glucagon during vehicle infusion.|60 minutes before the start of the infusion, again at the start of the infusion (time 0), and then every 30 minutes until 3 hours after the start of the infusion|Differences in peak glucagon concentration were compared between the two dose levels of Exendin-(9-39) of 300pmol/kg/min (3 subjects) and 500pmol/kg/min (3 subjects) were compared to the vehicle infusion (all 6 subjects).||pg/ml||Standard Error|Mean
856700|NCT00835731|Secondary|Ease of Further Mechanical Dilation in Women Following Exposure to Either Ripening Agent, as Per MD Report|"Scale:
None needed (score of 0) Very easy (score 1) Somewhat easy (score of 2) Moderate (score of 3) Somewhat difficult (score of 4) Very difficult (score of 5)"|3-4 hours after placement of ripening agent|||Participants|||Count of Participants
856597|NCT01162499|Secondary|Peak Plasma Glucagon-like Peptide-1 (GLP-1) Concentration During Infusion|To examine the effect of Exendin-(9-39) on plasma glucagon-like peptide-1 levels, samples were collected at various time points before and during the infusion [Exendin-(9-39) or vehicle] including: 60 minutes before the start of the infusion, again at the start of the infusion (time 0), and then every 30 minutes until 3 hours after the start of the infusion. The mean peak glucagon-like peptide-1 concentration for both Exendin-(9-39) doses were compared with the peak glucagon-like peptide-1 during vehicle infusion.|60 minutes before the start of the infusion, again at the start of the infusion (time 0), and then every 30 minutes until 3 hours after the start of the infusion|Differences were compared between the two dose levels of Exendin-(9-39) of 300pmol/kg/min (3 subjects) and 500pmol/kg/min (3 subjects) were compared to the vehicle infusion (all 6 subjects).||pmol/l||Standard Error|Mean
856598|NCT01162499|Secondary|Mean Acetaminophen Plasma Concentration Area Under the Curve (AUC 0-3h)|The effect of gastric emptying was examined using the acetaminophen method whereby acetaminophen (30mg/kg or maximum of 1500mg) was mixed into the Pediasure/formula during the meal tolerance testing. Blood samples were collected every 30 minutes and the absorption of acetaminophen was determined by the gastric emptying rate, as the serum concentrations correlate with gastric emptying of liquids. Mean acetaminophen levels for each group at each time point were used to calculate the Area Under the Concentration versus Time Curve (AUC expressed in μg*min/l) after the consumption of formula for each of the two Exendin-(9-39) dose levels and normal saline vehicle.|3 hours|AUC were compared between the two dose levels of Exendin-(9-39) of 300pmol/kg/min (3 subjects) and 500pmol/kg/min (3 subjects) were compared to the vehicle infusion (all 6 subjects).||μg*min/l||Standard Error|Mean
856599|NCT01162499|Secondary|Mean Plasma Insulin Area Under the Curve (AUC 0-3h)|To examine the effect of Exendin-(9-39) on plasma insulin levels, samples were collected at various time points before and during the infusion [Exendin-(9-39) or vehicle] including: 60 minutes before the start of the infusion, again at the start of the infusion (time 0), and then every 30 minutes until 3 hours after the start of the meal. Using this information, the mean plasma insulin area under the curve (AUC) from the start of the infusion to the end of the infusion (3 hours) was calculated for both doses of Exendin-(9-39) [300pmol/kg/min & 500pmol/kg/min] and compared with the vehicle.|3 hours|Changes were compared between the two dose levels of Exendin-(9-39) of 300pmol/kg/min (3 subjects) and 500pmol/kg/min (3 subjects) were compared to the vehicle infusion (all 6 subjects).||pmol*min/l||Standard Error|Mean
856600|NCT01162499|Primary|Mean Plasma Glucose Area Under the Curve (AUC 0-3h)|To examine the effect of Exendin-(9-39) on plasma glucose levels samples were collected at various time points before and during the infusion [Exendin-(9-39) or vehicle] including: 60 minutes before the start of the infusion, again at the start of the infusion (time 0), and then every 30 minutes until 3 hours after the start of the meal. Using this information, the mean plasma glucose area under the curve (AUC) from the start of the infusion to the end of the infusion (3 hours) was calculated for both doses of Exendin-(9-39) [300pmol/kg/min & 500pmol/kg/min] and compared with the vehicle.|3 hours|Changes were compared between the two dose levels of Exendin-(9-39) of 300pmol/kg/min (3 subjects) and 500pmol/kg/min (3 subjects) were compared to the vehicle infusion (all 6 subjects).||mg*min/dl||Standard Error|Mean
856601|NCT01154816|Secondary|Serum Concentration of Alisertib on the Seventh Day of Administration Prior to the Administration of the Day 7 Dose.|Serum concentration of alisertib on the seventh day of administration prior to the administration of the day 7 dose in nanograms/milliliter.|day 7 of protocol therapy|Of all eligible patients enrolled, 31 provided a seventh day of administration prior to the administration of the day 7 dose sample for analysis.||ng/ml||Standard Deviation|Mean
856602|NCT01154816|Secondary|Serum Concentration of Alisertib on the Fourth Day of Administration Prior to the Administration of the Day 4 Dose|Serum concentration of alisertib on the fourth day of administration prior to the administration of the day 4 dose in nanograms/milliliter.|day 4 of protocol therapy|Of all eligible patients enrolled, 30 provided a fourth day of administration prior to the administration of the day 4 dose sample for analysis.||ng/ml||Standard Deviation|Mean
856603|NCT01154816|Secondary|Serum Concentration of Alisertib on the First Day of Administration Six Hours After Administration|Serum concentration of alisertib on the first day of administration six hours after administration in nanograms/milliliter.|day 1 of protocol therapy|Of all eligible patients enrolled, 16 provided a first day of administration six hours after administration sample for analysis.||ng/ml||Standard Deviation|Mean
856604|NCT01154816|Secondary|Serum Concentration of Alisertib on the First Day of Administration Three Hours After Administration|Serum concentration of alisertib on the first day of administration three hours after administration in nanograms/milliliter.|day 1 of protocol therapy|Of all eligible patients enrolled, 16 provided a first day of administration three hours after administration sample for analysis.||ng/ml||Standard Deviation|Mean
856605|NCT01154816|Secondary|Serum Concentration of Alisertib on the First Day of Administration One Hour After Administration|Serum concentration of alisertib on the first day of administration one hour after administration in nanograms/milliliter.|day 1 of protocol therapy|Of all eligible patients enrolled, 16 provided a first day of administration one hour after administration infusion sample for analysis.||ng/ml||Standard Deviation|Mean
856606|NCT01154816|Secondary|Serum Concentration of Alisertib Prior to the First Day of Administration|Serum concentration of alisertib prior to the first day of administration in nanograms/milliliter.|day 1 of protocol therapy|Of all eligible patients enrolled, 32 provided a prior to the first day of administration sample for analysis.||ng/ml||Standard Deviation|Mean
856607|NCT01154816|Secondary|Number of Patients Cycles With Grade 3 or Higher Adverse Event|The number of patient-cycles in which the adverse event considered grade 3 or higher AE according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 considered by the treating physician to be possibly, probably or definitely related to alisertib.|Up to 24 months|116 patients contributed 360 patient-cycles to the analysis.||Patient-cycle|||Number
856608|NCT01154816|Primary|Number of Participants With Overall Response|For patients with recurrent solid tumors a patient who experienced a complete or partial response according to RECIST version 1.1 criteria is considered a responder. For patients with recurrent acute lymphoblastic leukemia a patient who experiences a bone marrow evaluation with < 5% blast cells on morphological evaluation of bone marrow will be considered a responder. For patients with recurrent acute myelogenous leukemia a patient who experiences a complete remission or complete remission with partial recovery of platelet count according to the AML International Working Group Criteria will be considered a responder.|From first dose of alisertib through 6 cycles of protocol therapy or until removal from protocol therapy whichever occurred first.|Of the 118 enrolled patients, two were not evaluable for the primary outcome measure. Neither received protocol therapy. One was enrolled in arm 11, one was enrolled in Arm 1.||Patients|||Number
856701|NCT00835731|Primary|Cervical Dilation in Women Following Exposure to Either Ripening Agent||3-4 hours after placement of ripening agent|||mm||Standard Deviation|Mean
856642|NCT01104402|Secondary|Serious Adverse Events (SAE)|Adverse event rates will be coded by body system and MedDRA classification term. Adverse events will be tabulated by treatment group and will include the number of subjects for whom the event occurred, the rate of occurrence, and the severity and relationship to study participation or study procedures.|12 months|||proportion of participants with SAEs|||Number
856643|NCT01104402|Secondary|Change in Prevalence of Resistant Species of Bacteria|Change in prevalence of resistant species of bacteria (Methicillin Resistant S. aureus, Pseudomonas aeruginosa, Burkolderia cepacia, Stenotrophomona maltophilia, Achromobacterxylosoxidans) in sputum between baseline and final visit (Visit 5 or early withdrawal) will be summarized by treatment group.|12 months|||percentage of subjects with new MRPA|||Number
856644|NCT01104402|Secondary|Treatment Burden|Change in treatment burden as measured by the Cystic Fibrosis Questionnaire revised (CFQ-R)will be analyzed using a linear mixed effects model incorporating baseline randomization factors FEV1 (<50%, 50-75%, and >75% predicted) and age (14-18 & 19+), treatment group, time (in weeks) and the interaction between treatment and time. Scores range from 0-100 with higher scores indicating less treatment burden.|Change from baseline to 12 months|||units on a scale||Standard Deviation|Mean
856665|NCT00939393|Primary|Mean Intra-patient Change in SNOT-20 Score at 24 Weeks Post-procedure Compared to Baseline|The 20 question Sino-Nasal Outcome Test (SNOT-20) will be used to evaluate sinus symptoms and sinus-symptom related quality of life (QOL) at baseline, 1 week, 4 weeks, 24 weeks and 52 weeks post-procedure. The change in SNOT-20 score at each post-procedure time point will be evaluated compared to baseline SNOT-20 score. Each of the 20 questions in the SNOT-20 survey is scored on a scale of 0 to 5, where '0' represents 'no problem' and '5' represents 'problem as bad as it can be'. The 20 questions are expressed as a mean of the scores. Therefore, the minimum mean score is zero and the maximum mean score is 5.|24 weeks|Eleven (11) In-Office subjects and 10 Operating Room subjects were missing data for this outcome measure.||scores on a scale||Standard Deviation|Mean
856645|NCT01104402|Secondary|Change in Health Related Quality of Life Scores as Assessed by the Cystic Fibrosis Questionnaire Revised (CFQ-R) (Respiratory Subscale Only(|Change in health related quality of life as measured by the Cystic Fibrosis Questionnaire revised (CFQ-R)will be analyzed using a linear mixed effects model incorporating baseline randomization factors FEV1 (<50%, 50-75%, and >75% predicted) and age (14-18 & 19+), treatment group, time (in weeks) and the interaction between treatment and time. The CFQ-R measures functioning in a variety of domains, including Physical Functioning, Vitality, Health Perceptions, Respiratory Symptoms, Treatment Burden, Role Functioning, Emotional Functioning, and Social Functioning. Only the respiratory subscale of the the CFQ-R was evaluated. This ranges from 0 to 100 with higher scores indicating better respiratory quality of life. A negative number indicates a decrease in respiratory quality of life.|Change from baseline to 12 months|||units on a scale||Standard Deviation|Mean
856646|NCT01104402|Secondary|Pulmonary Exacerbations|Percentage of participants who experienced at least one acute pulmonary exacerbation|12 months|||percentage of participants|||Number
856647|NCT01104402|Secondary|Cystic Fibrosis Respiratory Symptom Diary (CFRSD)|Change in CF respiratory symptoms as measured by the CFRSD. The CFRSD consists of 8 items which quantify symptom severity for the previous 24 hours to capture the magnitude of symptoms in stable CF, during medically treated CF exacerbations, and during recovery from an exacerbation. The CFRSD also includes emotional and activity impacts. Emotional impacts include frustration, sadness/depression, irritability, worry, and difficulty sleeping. Activity impacts include time spent sitting or lying down, reduction of usual activities, and missing school or work. will be analyzed using a linear mixed effects model incorporating baseline randomization factors FEV1 (<50%, 50-75%, and >75% predicted) and age (14-18 & 19+), treatment group, time (in weeks) and the interaction between treatment and time. The range of scores is 8 to 40 with higher scores indicating more severe symptoms.|12 months|||units on a scale||Standard Deviation|Mean
856648|NCT01104402|Primary|Change in FEV1|The primary outcome variable is FEV1 which will be obtained at quarterly study visits. The primary analysis will use a linear mixed effects model incorporating all FEV1 measurements to estimate the 52-week change in FEV1|12 months|||Liters||95% Confidence Interval|Mean
856649|NCT01101867|Secondary|1,5-anhydroglucitol Change|change in short-term measure of glycemia|day 1 to day 3||||||
856650|NCT01101867|Secondary|Treatment Satisfaction|treatment satisfaction questionnaire validated in-hospital|day 3||||||
856651|NCT01101867|Secondary|Rate of Change in Glucose||72 hour||||||
856652|NCT01101867|Secondary|Hypoglycemia|Number of patients with any hypoglycemic event (<70 mg/dl or <40 mg/dl)|72 hour|||participants|||Number
856653|NCT01101867|Secondary|Postprandial Glucose|Mean postprandial glucose was calculated per participant from the average of glucose values (post-breakfast, lunch, dinner) at day 3.|day 3|Data were only available in 79 subjects on day 3 due to hospital discharge or NPO status.||mg/dl||Standard Deviation|Mean
856654|NCT01101867|Primary|Mean Glucose|Mean glucose was calculated per participant from the average of glucose values over the 7-point (pre- and post-breakfast, lunch, dinner, and bed) glucose profile at day 3|day 3|Data were only available in 79 subjects on day 3 due to hospital discharge or NPO status.||mg/dl||Standard Deviation|Mean
856660|NCT01015807|Primary|Wound Hyperalgesia Index (WHA) Assessed 48 Hrs After Block Placement in the Different Groups|Determine which of three different TAP formulations (Placebo, TAP, Clo-TAP) has the most beneficial effect on the postoperative area of hyperalgesia 48hrs after the start of the cesarean section. The smaller the area of WHA, assessed in cm2, the better the outcome. Area sizes may range from 0 to any size.|48hrs after CS|||cm^2||Inter-Quartile Range|Mean
856666|NCT00939393|Secondary|Mean Intra-patient Change in SNOT-20 Score at 52 Weeks Post-procedure Compared to Baseline|The 20 question Sino-Nasal Outcome Test (SNOT-20) will be used to evaluate sinus symptoms and sinus-symptom related quality of life (QOL) at baseline, 1 week, 4 weeks, 24 weeks and 52 weeks post-procedure. The change in SNOT-20 score at each post-procedure time point will be evaluated compared to baseline SNOT-20 score. Each of the 20 questions in the SNOT-20 survey is scored on a scale of 0 to 5, where '0' represents 'no problem' and '5' represents 'problem as bad as it can be'. The 20 questions are expressed as a mean of the scores. Therefore, the minimum mean score is zero and the maximum mean score is 5.|52 weeks|Sixteen (16) In-Office subjects and 24 Operating Room subjects were missing data for this outcome measure.||scores on a scale||Standard Deviation|Mean
856667|NCT00939393|Secondary|Mean Intra-patient Change in SNOT-20 Score at 4 Weeks Post-procedure Compared to Baseline|The 20 question Sino-Nasal Outcome Test (SNOT-20) will be used to evaluate sinus symptoms and sinus-symptom related quality of life (QOL) at baseline, 1 week, 4 weeks, 24 weeks and 52 weeks post-procedure. The change in SNOT-20 score at each post-procedure time point will be evaluated compared to baseline SNOT-20 score. Each of the 20 questions in the SNOT-20 survey is scored on a scale of 0 to 5, where '0' represents 'no problem' and '5' represents 'problem as bad as it can be'. The 20 questions are expressed as a mean of the scores. Therefore, the minimum mean score is zero and the maximum mean score is 5.|4 weeks|Six (6) In-Office subjects and 2 Operating Room subjects were missing data for this outcome measure.||scores on a scale||Standard Deviation|Mean
856668|NCT00939393|Secondary|Mean Intra-patient Change in SNOT-20 Score at 1 Week Post-procedure Compared to Baseline|The 20 question Sino-Nasal Outcome Test (SNOT-20) will be used to evaluate sinus symptoms and sinus-symptom related quality of life (QOL) at baseline, 1 week, 4 weeks, 24 weeks and 52 weeks post-procedure. The change in SNOT-20 score at each post-procedure time point will be evaluated compared to baseline SNOT-20 score. Each of the 20 questions in the SNOT-20 survey is scored on a scale of 0 to 5, where '0' represents 'no problem' and '5' represents 'problem as bad as it can be'. The 20 questions are expressed as a mean of the scores. Therefore, the minimum mean score is zero and the maximum mean score is 5.|1 week|Five (5) In-Office subjects and 2 Operating Room subjects were missing data for this outcome measure.||scores on a scale||Standard Deviation|Mean
856669|NCT00939393|Secondary|Proportion of Participants With Post-operative Sinus Infections|Investigators reported the sinus infections as secondary to chronic rhinosinusitis (CRS) or other pre-existing conditions such as allergies. The rates of these sinus infections are consistent with the disease burden of the subjects and consistent with post procedure symptomatology associated with endoscopic sinus surgery (ESS).|52 weeks|||participants|||Number
856670|NCT00939393|Secondary|Proportion of Participants With Revisions (IO Only)|After sinus surgery, the patient may require a subsequent sinus procedure (a revision procedure) to address recurrence of disease. These revision procedures are assessed in this outcome measure.|52 weeks|||participants|||Number
856671|NCT00939393|Secondary|Mean Number of Debridements Per Participant (IO Only)|A debridement is a procedure to remove post-surgical crusts, mucus, and fibrin from obstructed nasal and sinus cavities after functional endoscopic sinus surgery. Each physician visit in which a debridement was performed was counted as one debridement.|52 weeks|||debridements||Standard Deviation|Mean
856672|NCT00939393|Secondary|Proportion of Participants Reporting No Pain or Pain of Low Intensity (IO Only)|Participants evaluated the per-procedural pain of their balloon dilation in office (IO = In Office) procedure on a scale from zero to 5, where '0' represented 'no pain' and '5' represented 'intense pain'. Scores of 0 through 2 were considered ratings of no pain or pain of low intensity. The endpoint reports the proportion of participants reporting no pain or pain of low intensity.|Day 0|One (1) In-Office subject was missing data for this outcome measure.||participants|||Number
856673|NCT00939393|Secondary|Proportion of Participants Rating Procedure as Tolerable (IO Only)|Participants evaluated the tolerability of their balloon dilation in office (IO = In Office) procedure on a scale from zero to 5, where '0' represented 'not tolerated' and '5' represented 'highly tolerable'. Scores of 3 through 5 were consdered tolerable ratings. The endpoint reports the proportion of participants rating the procedure as tolerable.|Day 0|Eight (8) In-Office subjects were missing data for this outcome measure.||participants|||Number
856674|NCT00939393|Secondary|Mean Intra-patient Change in Lund-MacKay CT Score [24 Weeks]|The Lund-MacKay (LMK) CT (computed tomography) score is a scoring system to evaluate radiographic opacification of the paranasal sinuses. The LMK score will be evaluated at 24 weeks post-procedure compared to baseline. The LMK scoring system rates each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses on a scale of 0 to 2, where '0' is 'no opacification' and '2' is 'complete opacification'. The scores for a given subject are totaled and expressed as the LMK score, where zero is the minimum score, and 24 is the maximum score. A higher score represents greater sinus disease burden.|24 weeks|Eight (8) In-Office subjects and 15 Operating Room subjects were missing data for this outcome measure.||Scores on a scale||Standard Deviation|Mean
856695|NCT00835731|Secondary|Women's Satisfaction With Cervical Ripening Method|"Scale:
1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied, 5 = very satisfied"|5 hours after placement of ripening agent|||units on a scale||Inter-Quartile Range|Median
856696|NCT00835731|Secondary|Subject Pain During Dilation and Evacuation|"Measure assesses subject pain during dilation and evacuation. Pain was assessed immediately after the D&E procedure. Subjects were asked to rate pain on a 6 point Likert scale:
0 = no pain 1-2 = mild pain 3 = moderate pain 4-5 = severe pain
Higher values represent a worse outcome."|3-4 hours after placement of ripening agent|||Scores on a scale||Inter-Quartile Range|Median
856697|NCT00835731|Secondary|Subject Pain During Ripening|"Measure assesses patient pain during cervical preparation. Pain was assessed after cervical ripening was complete, immediately before D&E procedure. Subjects were asked to rate pain on a 6 point Likert scale:
0 = no pain 1-2 = mild pain 3 = moderate pain 4-5 = severe pain
Higher values represent a worse outcome."|3-4 hours after placement of ripening agent|||Scores on a scale||Inter-Quartile Range|Median
856698|NCT00835731|Secondary|Number of Patients for Whom Physician Was Able to Complete Dilation and Evacuation Procedure on First Attempt||3-4 hours after placement of ripening agent|||participants|||Number
856699|NCT00835731|Secondary|Procedure Time for Dilation and Evacuation||3-4 hours after placement of ripening agent|||minutes||Inter-Quartile Range|Median
856733|NCT00781898|Primary|Relapse|A relapse event was defined as 10 or more days of opioid use in a 28-day (4-week) period as assessed by self-report or by testing of urine samples obtained every 2 weeks; a positive or missing sample was computed as 5 days of opioid use.|6 months|||Participants|||Count of Participants
856757|NCT00661427|Secondary|Safety|Terminology Criteria Version 3.0 or study specific toxicity tables provided in the protocol define severity.|at least weekly||||||
856758|NCT00661427|Primary|Number of Patients With Overall Objective Response|Patients will be evaluated for response according to a modified version of the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines|Approximately every 8 weeks with imaging up to two years|||participants|||Number
856776|NCT00571324|Secondary|Mean Plasma Insulin Area Under the Curve (AUC 0-6h)|To examine the effect of Exendin-(9-39) on plasma insulin levels, samples were collected at various time points before and during the infusion [Exendin-(9-39) or vehicle] including: 60 minutes before the start of the infusion, again at the start of the infusion (Time 0), and then every 20 minutes until 6 hours after the start of the infusion. Using this information, the mean plasma insulin area under the curve (AUC) from the start of the infusion to the end of the infusion (360 minutes) was calculated for each both Exendin-(9-39) and vehicle and compared.|6 hours|Subjects served as their own control for comparison between effects of Exendin-(9-39) and the normal saline vehicle.||pmol*min/L||Standard Error|Mean
856777|NCT00571324|Primary|Mean Blood Glucose Area Under the Curve (AUC 0-6h)|To examine the effect of Exendin-(9-39) on fasting blood glucose levels, samples were collected at various time points before and during the infusion [Exendin-(9-39) or vehicle] including: 60 minutes before the start of the infusion, again at the start of the infusion (Time 0), and then every 20 minutes until 6 hours after the start of the infusion. Using this information, the mean blood glucose area under the curve (AUC) from the start of the infusion to the end of the infusion (360 minutes) was calculated for each both Exendin-(9-39) and vehicle and compared.|6 hours|Subjects served as their own control for comparison between effects of Exendin-(9-39) and the normal saline vehicle.||mmol*min/L||Standard Error|Mean
856778|NCT00570089|Secondary|Seattle Angina Questionnaire (SAQ)|"Questionnaires will be completed (SAQ - Seattle Angina Questionnaire) at the end of each treatment period.
The Seattle Angina Questionnaire (SAQ) is a self-administered, 19-item questionnaire, a cardiac disease-related quality-of-life measure. The SAQ is well validated and sensitive to clinical changes. It has five subscales: physical limitation, angina stability, angina frequency, treatment satisfaction, and disease perception. The possible range of scores for each of the five subscales is 0 to 100, with higher scores indicating better quality of life. A change of 10 points in any of the subscales is considered to be clinically important.
Each final SAQ domain ranges from 0-100, where higher is a better outcome score. Subscales are not combined. Median, SD and range are calculated for each domain."|4 weeks and 10 weeks|||units on a scale||Full Range|Median
856779|NCT00570089|Primary|Cardiac Magnetic Resonance (CMRs)|Cardiac Magnetic Resonance (CMRs) (CMR 1 and CMR 2) end of the 4th week of treatment 1 and treatment 2 respectively, 4 hours after the morning dose of study drug was performed to measure myocardial perfusion defect in percentage.|4 weeks and 10 weeks|||Percentage of ischemic myocardium||Full Range|Median
856780|NCT00496964|Secondary|Muscle Activation During Maximal Contractions and Fatigue Contractions|muscle activation as EMG ratios of VMO/VL at 30 degrees maximal isometric contraction at 30degrees|4, 6, 12 weeks|||ratio VMO EMG to VL EMG||Standard Deviation|Mean
856781|NCT00496964|Secondary|Knee Extensor Fatigue|This is not available due to data collection errors|4, 6, 12 weeks|This is not available due to data collection errors|||||
856782|NCT00496964|Secondary|Maximal Knee Extensor Force During Concentric and Isometric Contractions||4, 6, 12 weeks|||Nm||Standard Deviation|Mean
856783|NCT00496964|Primary|Lower Extremity Functional Scale|The lower extremity functional scale (LEFS) is a self report questionnaire. Subjects rate 19 items related to general activities that require the lower extremities on a scale of 0 - 4. 0 = extreme difficulty or unable to perform the activity, 4 = No difficulty performing the activity. The total of all rankings are summed and divided by the maximum score (76). The score is reported as a percentage. 100% = no difficulty in performing any of the tasks. 0% = extreme difficulty or unable to perform all of the tasks.|4, 6, 12 weeks|No statistical analysis due to small number of subjects||percentage of total possible score||Standard Deviation|Mean
856784|NCT00496964|Primary|Functional Index Questionnaire|The Functional Index Questionnaire (FIQ) is a self report functional rating scale. Individuals rate eight-activities. Each activity is rated from 0 - 2 with ) being unable to perform the activity and 2 being able to perform the activity without difficulty. The total score is summed for a final score of 0 - 16. 0 indicates that the individual is ubable to perform any of the tasks, 16 indicates that the subject is able to perform all tasks without difficulty. The eight items include: walking (1 block and 1 mile), climbing stairs (2 flights and 4 flights), squatting, kneeling, prolonged sitting, and running|4, 6, 12 weeks|No statistical analysis due to small number of subjects||units on a scale||Standard Deviation|Mean
856785|NCT00496964|Primary|Change in Anterior Knee Pain Scale.|"Anterior Knee Pain Scale: a 13-item questionnaire; a TOTAL score of 0 = severe disability; a score of 100 = no pain or disability. (items are scored 0-5 or 0-10).
Change scores at 12 wks are reported. Inverted so positive values reflect improvement.
Included items: difficulty with: weight bearing, walking, stairs, squat, run, jump, prolonged sitting; presence of limp, swelling, patellar subluxation, atrophy of thigh, reduced knee flexion. Reference: Kujala et al: Scoring of Patellofemoral Disorders. J Arthroscopic Rel Surg, 9(2)159-163, 1993"|4, 6, 12 weeks|The Anterior Knee Pain Scale is a 13-item questionnaire; a score of 0 = severe disability; a score of 100 = no pain or disability. Change scores are reported. Positive values = improvement in symptoms.||Units on Scale||Standard Deviation|Mean
856786|NCT00496964|Primary|Visual Analog Scale Pain Ratings (VAS)|Visual Analog Scale pain rating (VAS). 10 cm line with anchors at 0 (no pain) and 10 cm (worst imaginable pain). Scores are in cm (0 - 10) 0 no pain, higher values greater pain. Results given are for change at 12 weeks compared to baseline (week 12 score - baseline score)|4, 6, 12 weeks|analysis per protocol. Drop out not included in analysis. mean reduction in Visual Analog Scale for Pain (VAS) from start to 12 weeks.||cm||Standard Deviation|Mean
856792|NCT00464568|Secondary|Mean Levels of Total Vasodilator Stimulated Phosphoprotein (VASP) Protein, Phosphorylated(Phospho)157 VASP (pVASP) and phospho239 VASP in Lavage Cells|Nasal lavage were taken 2 to 3 hour post morning dose; bilateral nasal lavage was conducted before the scrape. Nasal lavage samples were analyzed to explore the effects of GSK256066 on novel protein biomarkers including pVASP. Markers indicative of PDE4 inhibition such as VASP protein levels and phospho157 VASP were also measured in this study, in lavage cells, following positive data in an enabling study which showed increases in such protein levels in participants with allergic rhinitis following a single intranasal dose of salbutamol. Nasal lavage data from earlier studies showed that pVASP157 is the best marker and not pVASP239. pVASP239 was therefore not collected or analyzed as planned.|Day 1|All subjects population. Only those participants available at the specified time points were analyzed.||Percentage||Standard Deviation|Mean
856793|NCT00464568|Secondary|Nasal Lavage Concentrations of GSK256066|Nasal lavage samples were taken 2 -3 hour post morning dose and analyzed for GSK256066. Quantifiable levels of GSK256066 were observed in nasal lavage samples obtained 2-3 hours post-dose.|Day 1|PK concentration population.||Picogram/milliliter (pg/mL)||Geometric Coefficient of Variation|Geometric Mean
856794|NCT00464568|Secondary|Tmax and Tlast of Active Metabolite GSK614917|The PK of GSK614917 were assessed in plasma by determining Tmax and Tlast. All participants who received at least one dose of the study drug provided at least one sample for plasma PK analysis. Tmax and Tlast could not be determined for any participant at the 1 mcg GSK256066 dose.|Pre-dose, 15 minutes, 30 minutes, 1, 2, 3 and 4 hours post-dose on Day 1|PK parameter population.||Hour||Full Range|Median
856795|NCT00464568|Secondary|Time to Maximum Observed Plasma Drug Concentration (Tmax) and Time to Last Observed Plasma Drug Concentration (Tlast) of GSK256066|The PK of GSK256066 were assessed in plasma by determining Tmax and Tlast. All participants who received at least one dose of the study drug provided at least one sample for plasma PK analysis. Blood samples for PK were collected pre-dose, 15 minutes, 30 minutes, 1, 2, 3 and 4 hours post-dose and analyzed for GSK256066.|Pre -dose, 15 minutes, 30 minutes, 1, 2, 3 and 4 hours post-dose on Day 1|PK Parameter population. Only those participants with data available at the indicated time points were analyzed.||Hour||Full Range|Median
856796|NCT00464568|Secondary|Cmax of Active Metabolite GSK614917|The PK of GSK614917 were assessed in plasma by determining AUC(0-last). All participants who received at least one dose of the study drug provided at least one sample for plasma PK analysis. C max was not calculable for any participant at the 1 mcg GSK256066 dose.|Pre-dose, 15 minutes, 30 minutes, 1, 2, 3 and 4 hours post-dose on Day 1|PK parameter population. Only those participants with data available at the indicated time points were analyzed.||pg/mL||Geometric Coefficient of Variation|Geometric Mean
856797|NCT00464568|Secondary|Maximum Observed Plasma Drug Concentration (Cmax) of GSK256066|The PK of GSK256066 were assessed in plasma by determining Cmax. All participants who received at least one dose of the study drug provided at least one sample for plasma PK analysis. Blood samples for PK were collected pre-dose, 15 minutes, 30 minutes, 1, 2, 3 and 4 hours post-dose and analyzed for GSK256066.|Pre-dose, 15 minutes, 30 minutes, 1, 2, 3 and 4 hours post-dose on Day 1|PK Parameter population. Only those participants with data available at the indicated time points were analyzed.||Picogram per mililiter (pg/mL)||Geometric Coefficient of Variation|Geometric Mean
856798|NCT00464568|Secondary|AUC (0-last) of Active Metabolite GSK614917|The PK of GSK256066 were assessed in plasma by determining AUC(0-last). All participants who received at least one dose of the study drug provided at least one sample for plasma PK analysis. AUC (0-last) was not calculable in any participant at the 1, 10 or 50 mcg GSK256066 dose.|Pre-dose, 15 minutes, 30 minutes, 1, 2, 3 and 4 hours post-dose on Day 1|PK parameter population. Only those participants with data available at the indicated time points were analyzed.||pg * hr/mL||Geometric Coefficient of Variation|Geometric Mean
856799|NCT00464568|Secondary|Area Under the Plasma Drug Concentration Versus Time Curve (AUC0-last) of GSK256066|The pharmacokinetics (PK) of GSK256066 were assessed in plasma by determining AUC(0-last). All participants who received at least one dose of the active investigational product provided at least one sample for plasma PK analysis. Blood samples for PK were collected pre-dose, 15 minutes, 30 minutes, 1, 2, 3 and 4 hours post-dose and analyzed for GSK256066. AUC (0-last) was not calculable for any participant at 1 mcg GSK256066 dose.|Pre-dose, 15 minutes, 30 minutes, 1, 2, 3 and 4 hours post-dose on Day 1|PK parameter population comprised of all participants from the PK Concentration population (comprised of all participants from the All Subjects population for whom blood or nasal samples were taken for assaying study drug) for whom PK parameters were available. Only those participants with data available at the indicated time points were analyzed.||Picogram*hour per milliliter (pg*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
856800|NCT00464568|Secondary|Number of Participants With Clinical Chemistry Values of Potential Clinical Concern|Blood samples for clinical chemistry were taken before dosing. Whole blood samples were collected and processed according to the local procedures at site. The samples were transferred to the local laboratory for analysis. The participants with clinical chemistry values of potential clinical concern are reported. The potential clinical concern ranges (low and high) were given as: for total bilirubin levels (clinical concern upper value: >31 micromole/liter) and inorganic phosphorus level (normal range: 0.7-1.5 millimole/liter).|Up to 9 weeks|All subjects population.||Participants|||Number
856801|NCT00464568|Secondary|Number of Participants With Hematology Values of Potential Clinical Concern|Blood samples for hematology were taken before dosing. Whole blood samples were collected and processed according to the local procedures at site. The samples were transferred to the local laboratory for analysis. The participants with hematology of potential clinical concern are reported. The potential clinical concern ranges (low and high) were given as: for white blood cell count (clinical concern range: 3 to 20 giga cells/liter), neutrophils (normal range: 2.1 to 10.0 giga cells/liter), hemoglobin (clinical concern upper value: >180 grams/liter). Only those parameters for which at least one value of potential clinical concern was reported are summarized.|Up to 9 weeks|All subjects population.||Participants|||Number
856802|NCT00464568|Secondary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant.|Up to 9 weeks|All subjects population.||Participants|||Number
856803|NCT00464568|Secondary|Change From Baseline in Electrocardiogram (ECG) Values|Electrocardiogram variables evaluated included PR interval, QRS duration, QT interval, QT corrected by Bazett's formula (QTcB), QT corrected by Fridericia's formula (QTcF) and RR interval. ECG was performed pre-dose, one hour and four hour post-dose. The ECG measurements were made with the participant in a supine position having rested in this position for at least 10 minutes before each time-point. Baseline was defined as the pre-dose measurement on Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values|Baseline (Day 1) to 9 weeks|All subjects population.||Millisecond (msec)||Standard Deviation|Mean
856804|NCT00464568|Secondary|Mean Heart Rate Over Study Period|Vital signs included heart rate. Heart rate was measured pre-dose. The measurements were taken at 5 minutes interval during each treatment period. Vital signs measurements were made with the participant in a supine position having rested in this position for at least 5 minutes before the first reading at each time point. Measurements that deviated substantially from previous readings were repeated immediately.|Up to 9 weeks|All subjects population.||Beats/minute||Standard Deviation|Mean
856805|NCT00464568|Secondary|Mean Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Over Study Period|Vital signs included SBP and DBP. SBP and DBP were measured pre-dose. The measurements were taken at 5 minutes interval during each treatment period. Vital signs measurements were made with the participant in a supine position having rested in this position for at least 5 minutes before the first reading at each time point. Measurements that deviated substantially from previous readings were repeated immediately.|Up to 9 weeks|All subjects population.||Millimetres of mercury (mmHg)||Standard Deviation|Mean
856806|NCT00464568|Secondary|Mean Forced Expiratory Volume in One Second (FEV1)|The FEV1 is the volume of air forcefully exhaled in 1 second. The highest FEV1 value amongst the three recorded FEV1 readings was used for all FEV1 calculations. FEV1 was recorded pre-dose and at follow-up.|Up to 9 weeks|All subjects population.||Liters (L)||Standard Deviation|Mean
856807|NCT00464568|Primary|Mean Messenger Ribonucleic Acid (mRNA) Concentrations as a Measure of Gene Expression|The effect of GSK256066 on ribonucleic acid (RNA) levels indicative of Phosphodiesterase-4 (PDE4) inhibition in nasal scrape samples and on protein biomarkers of PDE4 inhibition in lavage samples was evaluated. Nasal lavage and scrapes were taken 2 to 3 hour post morning dose; bilateral nasal lavage was conducted before the scrape. Nasal scrape samples were taken from alternate nostrils. The novel RNA markers presented are cAMP responsive element modulator (CREM), dual specificity phosphatase 1(DUSP1), fos-like antigen 2(FOSL2), insulin receptor substrate 2 (IRS2), nuclear receptor subfamily 4, group A, member 2 (NR4A2), Phosphodiesterase-4A (PDE4A), Regulator of G-protein signalling 1 (RGS1), Serine/threonine protein kinase SNF1 like kinase (SNF1LK). Nasal lavage cytospins were stained with a SNF1LK specific monoclonal antibody by indirect immunofluorescence. Adjusted Geometric Mean and Standard error logs are presented.|Day 1|All Subjects population comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).||COPIES/50 nanogram (NG)||Standard Error|Geometric Mean
856809|NCT00381797|Secondary|Progression-free Survival Hazard Ratio by VEGF-R2 Expression|The association of VEGF-R2 expression with progression-free survival will be investigated for those strata that have a sufficient number of participants with VEGF-R2 measurements.|From start of treatment until the earliest of progressive disease, death, second malignancy or off study|Only the number of patients in strata E was sufficient to perform the analysis exploring the association of VEGF-R2 expression with progression-free survival.||Hazard Ratio||95% Confidence Interval|Number
856810|NCT00381797|Secondary|Progression-free Survival Hazard Ratio by VEGF-A Expression|The association of VEGF-A expression with progression-free survival will be investigated for those strata that have a sufficient number of participants with VEGF-A measurements.|From start of treatment until the earliest of progressive disease, death, second malignancy or off study|Only the number of patients in strata E was sufficient to perform the analysis exploring the association of VEGF-A expression with progression-free survival.||Hazard Ratio||95% Confidence Interval|Number
856811|NCT00381797|Secondary|Progression-free Survival Hazard Ratio by Carbonic Anhydrase 9 (CA9) Expression|The association of CA9 expression with progression-free survival will be investigated for those strata that have a sufficient number of participants with CA9 measurements.|From start of treatment until the earliest of progressive disease, death, second malignancy or off study|Only the number of patients in strata E was sufficient to perform the analysis exploring the association of carbonic anhydrase 9 (CA9) expression with progression-free survival.||Hazard Ratio||95% Confidence Interval|Number
856812|NCT00381797|Secondary|Progression-free Survival Hazard Ratio by Hypoxia Inducible Factor-2alpha Expression|The association of hypoxia inducible factor-2alpha expression with progression-free survival will be investigated for those strata that have a sufficient number of participants with hypoxia inducible factor-2alpha measurements. The hazard ratio was reported for patients who had hypoxia inducible factor-2alpha expression.|From start of treatment until the earliest of progressive disease, death, second malignancy or off study|The number of patients in strata C and D was not sufficient to perform the analysis exploring the association of hypoxia inducible factor-2alpha expression with progression-free survival. Thus the association analysis was performed for the patients in Stratum E only.||Hazard Ratio||95% Confidence Interval|Number
856813|NCT00381797|Secondary|Number of Patients With High VEGF-R2 Expression at Baseline|The expression of Hypoxia inducible factor-2α, carbonic anhydrase IX (CA9), VEGF-A, and VEGF-R2 will be estimated by immunohistochemistry of paraffin sections in the medulloblastoma,ependymoma and low grade glioma strata. Reported separately for each stratum.|Baseline|Only strata were reported, in which the patients had tissue samples available.||participants|||Number
856814|NCT00381797|Secondary|Number of Patients With High VEGF-A Expression at Baseline|The expression of Hypoxia inducible factor-2α, carbonic anhydrase IX (CA9), VEGF-A, and VEGF-R2 will be estimated by immunohistochemistry of paraffin sections in the medulloblastoma,ependymoma and low grade glioma strata. Reported separately for each stratum.|Baseline|Only strata were reported, in which the patients had tissue samples available.||participants|||Number
856815|NCT00381797|Secondary|Number of Patients With High Carbonic Anhydrase 9 Expression at Baseline|The expression of Hypoxia inducible factor-2α, carbonic anhydrase IX (CA9), VEGF-A, and VEGF-R2 will be estimated by immunohistochemistry of paraffin sections in the medulloblastoma,ependymoma and low grade glioma strata. Reported separately for each stratum.|Baseline|Only strata were reported, in which the patients had tissue samples available.||participants|||Number
856816|NCT00381797|Secondary|Number of Patients With High Hypoxia Inducible Factor-2alpha Expression at Baseline|The expression of Hypoxia inducible factor-2α, carbonic anhydrase IX (CA9), VEGF-A, and VEGF-R2 will be estimated by immunohistochemistry of paraffin sections in the medulloblastoma,ependymoma and low grade glioma strata. Reported separately for each stratum.|Baseline|Only strata were reported, in which the patients had tissue samples available.||participants|||Number
856817|NCT00381797|Secondary|Correlation of the Change in Vascular Endothelial Growth Factor Receptor-2 (VEGF-R2) Expression in Peripheral Blood Mononuclear Cells (PBMC) From Baseline With the Change in Perfusion From Magnetic Resonance Imaging|Spearman correlation coefficient is used to measure the correlation of the changes in VEGF-R2 with the changes in perfusion ratios. The changes are calculated by values at Day 15 minus values at baseline for VEGF-2 in Section 17 above and perfusion in Section 18 above, respectively. The correlation coefficients are reported in each stratum separately.|Baseline and Day 15 (after 2 doses of Bevacizumab) of course 1|The analyses are performed for the patients who had the changes in both VEGF-R2 and perfusion.||Correlation Coefficient|||Number
856818|NCT00381797|Secondary|Descriptive Statistics for the Change of Perfusion in Magnetic Resonance Imaging Concurrently Measured With the Change in Vascular Endothelial Growth Factor Receptor-2 (VEGF-R2) Expression in Peripheral Blood Mononuclear Cells (PBMC)|The change of perfusion in magnetic resonance imaging is calculated by taking the difference between the Day-15 measurements and the Baseline measurements for patients who had the changes of VEGF-R2. The purpose of reporting the descriptive statistics is to provide the information for the correlation coefficients reported in the next section, Section 19. MR perfusion ratio is the ratio of the perfusion measurements in the tumor and the perfusion measurerement in comparative frontal while matter, which is the comparative healthy part of the brain.|Baseline and Day 15 (after 2 doses of Bevacizumab) of course 1|The analyses are performed for the patients who had the changes in both VEGF-R2 and perfusion.||Ratio||Standard Error|Mean
856819|NCT00381797|Secondary|Descriptive Statistics for the Changes in Vascular Endothelial Growth Factor Receptor-2 (VEGF-R2) Expression in Peripheral Blood Mononuclear Cells (PBMC) Concurrently Measured With the Changes in Perfusion From Magnetic Resonance Imaging|The changes in VEGF-R2 are calculated by values at Day 15 minus values at baseline for the patients who had the changes in perfusion from magnetic resonance perfusion imaging. The purpose of reporting descriptive statistics of changes of VEGF-R2 is to provide the information for the correlation coefficients in Section 19.|Baseline and Day 15 (after 2 doses of Bevacizumab) of course 1|The analyses are performed for the patients who had the changes in both VEGF-R2 and perfusion.||Ratio||Standard Error|Mean
856820|NCT00381797|Secondary|Change in Vascular Endothelial Growth Factor Receptor-2 (VEGF-R2) Expression in Peripheral Blood Mononuclear Cells (PBMC) From Baseline to Day-15|The change in VEGF-R2 was calculated from baseline to the time of the 2nd dose (values of 24-48 hours after the 2nd dose at Day 15 - values of pre-dose 1 Day1, i.e., baseline). VEGF-R2 is measured in the relative phosphorylation score which is generated as a ratio of normalized phosphorylated VEGF-R2 versus normalized total VEGF-R2 protein.|Baseline and 24-48 hours after the 2nd dose of Bevacizumab in course 1|||Ratio||Full Range|Median
856821|NCT00381797|Secondary|Terminal Half-life|"Blood specimens were collected on the days listed for pharmacokinetic studies for Bevacizumab. These specimens were analyzed to produce steady-state plasma Bevacizumab concentration-time data in study participants. The concentration-time data were analyzed to provide an estimate of the PK parameters. The data were collected but the analyses of the PK data were conducted by Genentech using a broader cohort of pediatric patients from multiple trials in the paper Bevacizumab dosing strategy in paediatric cancer patients based on population pharmacokinetic analysis with external validation published by British Journal of Clinical Pharmacology,2016 volume 81(1):148-160. The estimates of the terminal half-life were calculated by the method described in the paper."|Baseline, Course 1 Day 1, Course 1 Day 15, Course 2 Day 1, Course 3 Day 1, Course 4 Day 1, and Course 5 Day 1|The study participants across the strata (stratum A, stratum B, stratum C, stratum D, and stratum E) were combined for this secondary objective. The number of participants with data was available.||hours||Standard Deviation|Mean
856822|NCT00381797|Secondary|Systemic Clearance|"Blood specimens were collected on the days listed for pharmacokinetic studies for Bevacizumab. These specimens were analyzed to produce steady-state plasma Bevacizumab concentration-time data in study participants. The concentration-time data were analyzed to provide an estimate of the systemic clearance. The data were collected but the analyses of the PK data were conducted by Genentech using a broader cohort of pediatric patients from multiple trials in the paper Bevacizumab dosing strategy in paediatric cancer patients based on population pharmacokinetic analysis with external validation published by British Journal of Clinical Pharmacology, 2016 volume 81(1):148-160. The estimates of the systemic clearance were calculated by the model described in the paper."|Baseline, Course 1 Day 1, Course 1 Day 15, Course 2 Day 1, Course 3 Day 1, Course 4 Day 1, and Course 5 Day 1|The study participants across the strata (stratum A, stratum B, stratum C, stratum D, and stratum E) were combined for this secondary objective. The number of participants with data was available.||ml/h||Standard Deviation|Mean
856948|NCT02542072|Secondary|Overall Fit Acceptance|Overall fit acceptance for comfilcon A and samfilcon A lenses. Scale 0-4, 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimum acceptable, early review, 3=Not perfect but okay to dispense, 4=Perfect|Baseline, 2 weeks, 4 weeks|||units on a scale||Standard Deviation|Mean
856823|NCT00381797|Secondary|Volume of Distribution|"Blood specimens were collected on the days listed for pharmacokinetic studies for Bevacizumab. These specimens were analyzed to produce steady-state plasma Bevacizumab concentration-time data in study participants. The concentration-time data were analyzed to provide an estimate of the volume of distribution. The data were collected but the analyses of the PK data were conducted by Genentech using a broader cohort of pediatric patients from multiple trials in the paper Bevacizumab dosing strategy in paediatric cancer patients based on population pharmacokinetic analysis with external validation published by British Journal of Clinical Pharmacology ,2016 volume 81(1):148-160. The estimates of the volume of distribution were calculated by the model described in the paper."|Baseline, Course 1 Day 1, Course 1 Day 15, Course 2 Day 1, Course 3 Day 1, Course 4 Day 1, and Course 5 Day 1|The study participants across the strata (stratum A, stratum B, stratum C, stratum D, and stratum E) were combined for this secondary objective. The number of participants with data was available.||ml||Standard Deviation|Mean
856824|NCT00381797|Secondary|Association of Log-transformed Tumor Perfusion Ratio With Progression-free Survival (PFS) Using Hazard Ratio Estimates|Using Cox Proportional Hazards Models, the association of tumor perfusion ratio with progression-free survival will be investigated. Magnetic resonance (MR) perfusion imaging is performed to investigate surrogate markers of tumor growth. Tumor perfusion ratios were longitudinal. As we are not comparing the strata or study arms, analyses will be done in each stratum separately, and thus we cannot report the Cox model results in the Statistical Analysis section. We consider these estimates 'descriptive' within each stratum. In this analysis, the hazard ratio is a relative measure of likelihood that a study participant experiences the event of interest compared to another participant who has a one-unit lower Log-transformed tumor volume perfusion ratio. The Cox survival model provides the mean hazard ratio along with its 95% confidence interval, which we report below.|From start of treatment until the earliest of progressive disease, death, second malignancy or off study, OR up to 2 years|The analyses cannot be performed with the Cox proportional hazard model since there are no sufficient measurements of perfusion ratio and events.|||||
856825|NCT00381797|Secondary|Association of Log-transformed Tumor Diffusion Ratio With Progression-free Survival (PFS) Using Hazard Ratio Estimates|Using Cox Proportional Hazards Models, the association of tumor diffusion ratios with progression-free survival will be investigated. Magnetic resonance (MR) diffusion imaging is performed to investigate surrogate markers of tumor growth. Tumor diffusion ratios were longitudinal. As we are not comparing the strata or study arms, analyses will be done in each stratum separately, and thus we cannot report the Cox model results in the Statistical Analysis section. And we consider these estimates 'descriptive' within each stratum. In this analysis, the hazard ratio is a relative measure of likelihood that a study participant experiences the event of interest compared to another participant who has a one-unit lower Log-transformed tumor diffusion ratio. The Cox survival model provides the mean hazard ratio along with its 95% confidence interval, which we report below.|From start of treatment until the earliest of progressive disease, death, second malignancy or off study|Patients had diffusion ratio at pre-treatment scans and at least one on treatment scans.||Hazard Ratio||95% Confidence Interval|Mean
856826|NCT00381797|Secondary|Association of Log-transformed Volume of Cystic Necrosis With Progression-free Survival (PFS) Using Hazard Ratio Estimates|Using Cox Proportional Hazards Models, the association of cystic necrosis with progression-free survival will be investigated. Volumetric magnetic resonance (MR) imaging is performed to investigate surrogate markers of tumor growth. Volumes of cystic necrosis were longitudinal. As we are not comparing the strata or study arms, analyses will be done in each stratum separately, and thus we cannot report the Cox model results in the Statistical Analysis section and we consider these estimates 'descriptive' within each stratum. In this analysis, the hazard ratio is a relative measure of likelihood that a study participant experiences the event of interest compared to another participant who has a one-unit lower Log-transformed tumor volume based on cystic necrosis. The Cox survival model provides the mean hazard ratio along with its 95% confidence interval, which we report below.|From start of treatment until the earliest of progressive disease, death, second malignancy or off study, OR up to 2 years|Patients had volume of cystic necrosis at Pre-treatment and at least one on treatment.||Hazard Ratio||95% Confidence Interval|Mean
856827|NCT00381797|Secondary|Association of Log-transformed Tumor Enhancing Volume With Progression-free Survival (PFS) Using Hazard Ratio Estimates|Using Cox Proportional hazards Models, the association of Log-transformed tumor enhancing volume with progression-free survival will be investigated. Volumetric magnetic resonance (MR) imaging is performed to investigate surrogate markers of tumor growth. Tumor enhancing volumes were longitudinal. As we are not comparing the strata or study arms, analyses will be done in each stratum separately, and thus we cannot report the Cox model results in the Statistical Analysis section and we consider these estimates 'descriptive' within each stratum. In this analysis, the hazard ratio is a relative measure of likelihood that a study participant experiences the event of interest compared to another participant who has a one-unit lower Log-transformed tumor enhancing volume. The Cox survival model provides the mean hazard ratio along with its 95% confidence interval, which we report below.|From start of treatment until the earliest of progressive disease, death, second malignancy or off study, OR up to 2 years|Patients had tumor enhancing volume at Pre-treatment and at least one on treatment.||Hazard Ratio||95% Confidence Interval|Mean
856828|NCT00381797|Secondary|Association of Log-transformed Tumor Volume Based on FLAIR With Progression-free Survival (PFS) Using Hazard Ratio Estimates|Using Cox proportional hazards models, the association of tumor volume based on FLAIR images with PFS will be investigated for those strata that have a sufficient number of participants with volume FLAIR measurements. Volumetric magnetic resonance imaging is performed to investigate surrogate markers of tumor growth. Volume FLAIR measurements were longitudinal. As we are not comparing the strata, analyses will be done in each stratum separately, and thus we cannot report the Cox model results in the Statistical Analysis section. We consider these estimates 'descriptive' within each stratum. In this analysis, the hazard ratio is a relative measure of likelihood that a study participant experiences the event of interest compared to another participant who has a one-unit lower Log-transformed tumor volume based on FLAIR. The Cox survival model provides the mean hazard ratio along with its 95% confidence interval, which we report below.|From start of treatment until the earliest of progressive disease, death, second malignancy or off study OR up to 2 years|Patients had Flair volume at Pre-treatment and at least one on treatment.||Hazard Ratio||95% Confidence Interval|Mean
856829|NCT00381797|Secondary|Change in Diffusion Ratio Between the Baseline and Day 15 Brain Image|Diffusion ratio obtained from magnetic resonance (MR) diffusion imaging may explain changes in the tumor after therapy. Changes in the diffusion ratio will be reported for those strata that have a sufficient number of participants with MR diffusion imaging. The change was calculated from diffusion ratio at Baseline to diffusion ratio at Day 15 (values of diffusion ratio at Day 15 -values of diffusion ration at baseline). The higher of diffusion ratio is better. MR diffusion ratio is the diffusion solid part of tumor divided by the diffusion frontal white matter. There is no a unit available.|Baseline and day 15|There are no sufficient data for the analyses in the Medulloblastoma arm.||Ratio||Full Range|Median
856830|NCT00381797|Secondary|Change in Perfusion Ratio Between the Baseline and Day 15 Brain Imaging|"Perfusion ratio obtained from magnetic resonance(MR) diffusion imaging may explain changes in the tumor after therapy. Changes in the perfusion ratio will be reported for those strata that have a sufficient number of participants with MR diffusion imaging. The change was calculated from perfusion ratio at Baseline to perfusion ratio at Day 15(values of perfusion ratio at Day 15 - values of perfusion ratio at baseline). The higher of perfusion ratio is worse.
MR perfusion ratio is perfusion solid part of tumor from CBV divided by perfusion frontal while matter. There is no a unit available."|Baseline and day 15|There are no sufficient data for the analyses in the Medulloblastoma arm and Ependymoma arm.||Ratio||Full Range|Median
856831|NCT00381797|Secondary|Progression-free Survival|Progression-Free survival is the interval of time between of protocol treatment and minimum date of documentation of progressive Disease,second malignancy,death due to any cause, or date of last follow-up. Progressive neurologic abnormalities or worsening neurologic status not explained by causes unrelated to tumor progression,OR the appearance of new tumor OR a > 25% increase in the sum of the products of two longest perpendicular diameters of all measurable tumors. K-M method was used to estimate progression-free survival.|From start of treatment up to 2 years|The patients were treated with any dose treatment.||Months||95% Confidence Interval|Median
856832|NCT00381797|Secondary|Cumulative Incidence of Sustained Objective Responses|Cumulative incidence of sustained objective response provides a percentage of participants experiencing the event of interest at a given follow-up time point (for example, 6-months, 1-year, etc.) in the presence of competing events such as progressive disease or death, and it is estimated using the event data for both the event of interest and the competing events experienced by the study participants. In this sense, it is different than the incidence rates estimated in epidemiological studies in terms of 'incidences per 1000 person years. 6-month Cumulative incidence of sustained objective responses will be reported separately for each stratum.|From the first imaging after treatment up to 2 years|Two patients in the Stratum A,one patient in the Stratum C, and one patient in the Stratum D were inevaluable for this outcome measure.||Percentage of Participants|||Number
856833|NCT00381797|Secondary|Number of Study Participants With Grade 3 or 4 Treatment-related Toxicity|Adverse events are monitored and graded according to the Common Terminology Criteria for Adverse Events. The grade 1 = mild, grade 2=moderate, grade 3 =severe, grade 4=life threatening/disabling, grade 5=death.|From day 1 of treatment until off study|The patients were treated with any dose treatment.||participants|||Number
856834|NCT00381797|Primary|Sustained Disease Stabilization Rate Associated With Bevacizumab and Irinotecan in Patients With Recurrent or Progressive Low-grade Glioma (Stratum E)|Disease stabilization is defined as a complete response(CR) or partial response(PR) observed during the first four courses and sustained for 8 weeks; or stable disease (SD) sustained for 6 courses characterized by SD at the end of course 2, at the end of course 4 and at the end of course 6. CR is complete disappearance of all enhancing tumor. PR is >= 50% reduction in tumor size. SD is at least stable and maintenance corticosteroid dose not increased in neurologic examination.|From day 1 of treatment up to 24 weeks|Patients with recurrent or progressive low grade glioma were treated with any courses.||participants||95% Confidence Interval|Number
856835|NCT00381797|Primary|Objective Response Rate Sustained for ≥ 8 Weeks|Objective response is either a complete response or a partial response observed during the first four courses of treatment and sustained for 8 weeks. The objective response rate will be reported separately for patients with recurrent/progressive malignant glioma(Stratum A), recurrent/progressive instrinsic brain stem tumors(Stratum B), recurrent/progressive medulloblastoma(Stratum C), and recurrent/progressive ependymoma(Stratum D). CR is complete disappearance of all enhancing tumor. PR is >= 50% reduction in tumor size. This outcome measures is not defined for the Stratum E in the protocol.|From day 1 of treatment up to 24 weeks|Two patients in the Stratum A,one patient in the Stratum C, and one patient in the Stratum D were inevaluable for this outcome measure.||participants|||Number
856836|NCT00376688|Primary|Clinical Benefit Rate (Complete Response, Partial Response, or Stable Disease)|"Response evaluation criteria in solid tumors (RECIST) criteria version 1.0 was used for response evaluation. Clinical benefit rate is defined as the proportion of subjects experiencing a complete response (CR), partial response (PR), or stable disease (SD) for at least 24 weeks.
Evaluation of target lesions: Complete Response (CR)-- Disappearance of all target lesions; Partial Response (PR)-- At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Stable Disease (SD)-- Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started;
Evaluation of non-target lesions: Complete Response (CR)-- Disappearance of all non-target lesions and normalization of tumor marker level; Incomplete Response/ Stable Disease (SD)-- Persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits"|Up to 24 months|||percentage of participants|||Number
856837|NCT00357656|Secondary|Incidence of Factor VIII Inhibitory Antibody (≥0.4 Bethesda Units Using the Nijmegen Modification of the Bethesda Assay Formation)|Number of participants that developed Factor VIII inhibitory antibody during the study.|Throughout the study period of approximately 9-26 weeks per participant|Participants in the Safety Analysis Set treated with at least one ADVATE infusion.||Participants|||Number
856838|NCT00357656|Secondary|Number of Adverse Events Related to the Administration of the Study Product.|All AEs from the first study drug exposure until the study completion/discontinuation date were to be recorded. Each AE was to be evaluated by the investigator for causal relationship (i.e., unrelated, possibly related or probably related) to the study product.|From first study drug exposure until study completion/discontinuation (approximately 9-26 weeks per subject)|Participants in the Safety Analysis Set treated with at least one ADVATE infusion.||Adverse Events|||Number
856839|NCT00357656|Secondary|Number of Units of Packed Red Blood Cells Transfused||During the first postoperative 24 hours|"All subjects who were randomized to receive BI or CI and have observed drainage volumes up to 24 hours including hematocrit results for these drainage fluids.
The overall number of participants treated by BI and CI comprises the number of participants in Stratum A, B and C for BI and CI."||PRBC Units||Standard Deviation|Mean
856840|NCT00357656|Secondary|Number of Bleeding Episodes During Treatment With Continuous or Bolus Infusion|To simplify the results below: Bleeding episodes were reported for 4 subjects (3 subjects on bolus infusion: 2 in Stratum A and 1 in Stratum B, and 1 subject on continuous infusion/Stratum B). The 4 subjects had 1 bleeding episode each. No bleeding episodes were reported for Stratum C.|Through Postoperative Day 7|"All subjects who were randomized to receive BI or CI and have observed drainage volumes up to 24 hours including hematocrit results for these drainage fluids.
The overall number of participants treated by BI and CI comprises the number of participants in Stratum A, B and C for BI and CI."||Bleeding Episodes||Standard Deviation|Mean
856841|NCT00357656|Secondary|Actual Postoperative Blood Loss Compared to the Expected Average Blood Loss Until Drain Removal as Predicted Preoperatively by the Surgeon|"The total blood loss for the postoperative period (from end of surgery until drain removal) was adjusted for the expected blood loss by applying a log-transformation of the blood loss data.
The drainage volume was measured every 8 hours +/- 30 minutes during the first 24 hours. If the drainage continued beyond 24 hours, the PRBC volume and hemoglobin was to be measured cumulatively every 24 hours or whenever the drainage bottle was emptied and at the time of drain removal. Prior to surgery, the operating surgeon was to predict the estimated duration of surgery and the volume (mL) of the estimated expected blood loss for the surgery in a hemostatically normal individual of the same sex, age, and stature as the study subject for the first 24 hours postoperatively, and for the postoperative period until drain removal, if drainage continued beyond 24 hours.
Units: Milliliter of blood"|From end of surgery (application of compressive dressing and release of tourniquet, if applicable) until drain removal (up to postoperative day 7).|"All subjects who were randomized to receive BI or CI and have observed drainage volumes up to 24 hours including hematocrit results for these drainage fluids.
The overall number of participants treated by BI and CI comprises the number of participants in Stratum A, B and C for BI and CI."||Milliliter||Standard Deviation|Mean
856842|NCT00357656|Secondary|Actual Postoperative Blood Loss During the First 24 Hours Compared With the Average Blood Loss as Predicted Preoperatively by the Operating Surgeon|"Drainage fluid volume was to be measured cumulatively and recorded every 8 hours ± 30 minutes during the first 24 hours following surgery. Prior to surgery, the operating surgeon was to predict the estimated duration of surgery and the volume (mL) of the estimated expected blood loss for the surgery in a hemostatically normal individual of the same sex, age, and stature as the study subject 1) for the intraoperative procedure (defined as the time period from incision to application of compressive dressing and release of tourniquet, if applicable), 2) for the first 24 hours postoperatively, and 3) for the postoperative period until drain removal, if drainage continued beyond 24 hours.
Units: Milliliter of blood"|During the first 24 postoperative hours blood loss was measured every 8 hours ± 30 minutes|"All subjects who were randomized to receive BI or CI and have observed drainage volumes up to 24 hours.
The overall number of participants treated by BI and CI comprises the number of participants in Stratum A, B and C for BI and CI."||Milliliter||Standard Deviation|Mean
856843|NCT00357656|Primary|Cumulative Packed Red Blood Cell (PRBC) Volume in the Drainage Fluid During the First 24 Hours Following Surgery in Subjects Receiving ADVATE (rAHF-PFM) by Bolus (BI) or Continuous Infusion (CI)|"Drainage fluid volume was to be measured cumulatively and recorded every 8 hours ± 30 minutes during the first 24 hours following surgery.
Unit of measure: Tera per Liter is the PRBC concentration in 10^12 units per 1 liter of drainage fluid."|During the first postoperative 24 hours every 8 hours ± 30 minutes the drainage fluid was to be recorded..|"All subjects who were randomized to receive BI or CI and have observed drainage volumes up to 24 hours including hematocrit results for these drainage fluids.
The overall number of participants treated by BI and CI comprises the number of participants in Stratum A, B and C for BI and CI."||Tera per Liter||Standard Deviation|Mean
856949|NCT02542072|Secondary|Lens Tightness Push-up|"Investigator assessment of lens tightness push-up for comfilcon A and samfilcon A lenses.
Scale 0%-100% continuous scale, 100%=No movement, 50%=Optimum, 0%=Falls from cornea without lid support"|Baseline, 2 weeks, 4 weeks|||percentage of mean lens tightness|Eyes|Standard Deviation|Mean
856950|NCT02542072|Secondary|Primary Gaze Lag|Investigator assessment of primary gaze lag for comfilcon A and samfilcon A lenses. Scale 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement|Baseline, 2 weeks, and 4 weeks|||units on a scale|Eyes|Standard Deviation|Mean
856951|NCT02542072|Secondary|Post-Blink Movement|Post-blink movement for comifilcon A and samfilcon A lenses are assessed. 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement|Baseline, 2 weeks, 4 weeks|||units on a scale|Eyes|Standard Deviation|Mean
856947|NCT02542072|Secondary|Dryness|Subjective response of dryness for comfilcon A and samfilcon A lenses during a typical day of wear and prior to removal. Scale of 0-10, 10=No dryness, 0=Extremely dry|Baseline, 2 weeks, 4 weeks|||units on a scale||Standard Deviation|Mean
856964|NCT02542072|Primary|Comfort|Subjective ratings of comfort (comfort after insertion, typical comfort just prior to removal, and overall comfort) for comfilcon A and samfilcon A assessed at baseline, 2 weeks, and 4 weeks. Scale of 0-10 (0=painful, 10=can't feel the lenses).|Baseline, 2 weeks, 4 weeks|Number of participants analyzed is different from participant flow due to protocol deviations.||units on a scale||Standard Deviation|Mean
856995|NCT02454608|Primary|Subjective Sinonasal Symptoms on 10cm Visual Analogue Scale(VAS)|Minimum Score: 0 Maximum Score: 100 A higher score indicates a worse outcome.|baseline to week 8|Intention-to-treat analysis||units on a scale||Standard Error|Least Squares Mean
856990|NCT02454608|Other Pre-specified|Diastolic Blood Pressure||Mean change between baseline and week 8 measurements|||mmHg||Standard Deviation|Mean
856991|NCT02454608|Other Pre-specified|Systolic Blood Pressure||Mean change between baseline and week 8 measurements|||mmHg||Standard Deviation|Mean
856992|NCT02454608|Other Pre-specified|Heart Rate||Mean change between baseline and week 8 measurements.|||beats per minute||Standard Deviation|Mean
856993|NCT02454608|Secondary|Objective Sinonasal Symptoms on Lund-McKay Score(LMS)|Minimum Score: 0 Maximum Score: 24 Higher value represents worse outcome.|Week 8|Intention-to-treat analysis||units on a scale||Standard Deviation|Mean
856994|NCT02454608|Secondary|Objective Sinonasal Symptoms on Lund-Kennedy Score(LKS)|Minimum Score: 0 Maximum Score: 12 Higher value represents worse outcome.|baseline to week 8|Intention-to-treat analysis||units on a scale||Standard Error|Least Squares Mean
857006|NCT02422797|Secondary|Change From Baseline Treatment Satisfaction Using the HIV Treatment Satisfaction Questionnaire (HIV TSQ) at Weeks 4, 24 and 48 or Withdrawal From the Study|The HIV TSQ is a 10-item self-reported scale that measures overall satisfaction with treatment and by specific domains e.g., convenience, flexibility. Each item is scored 0-6 where a higher score indicates the greater improvement in the past few weeks. These items are summed up to produce a treatment satisfaction total score (0 to 60) and 2 subscales: general satisfaction/clinical and lifestyle/ease subscales (0 to 30). The HIV TSQ was administered as a paper questionnaire. Between and within treatment group comparisons were assessed on change from Baseline treatment satisfaction using the HIV TSQ at Weeks 4, 24 and 48 or withdrawal from the study. Total score, lifestyle/ease score and General satisfaction/clinical sub-score (CS) have been summarized. LOCF was used as primary method of analysis. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to Week 48|ITT-E Population||Score on a scale||Full Range|Median
857007|NCT02422797|Secondary|Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 4, 24 and 48 or Withdrawal From the Study|The Symptom Distress Module, also called the HIV Symptom Index or Symptoms Impact Questionnaire, is a 20-item self-reported measure that addresses the presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. Between and within treatment group comparisons were assessed on change from Baseline in pre-specified treatment symptoms using the Symptom Distress Module at Weeks 4, 24 and 48 or withdrawal from the study. Change from Baseline in Symptom count and symptom bother score have been summarized. The symptom bother score is based on the score for each symptom present ranging from 1 (it doesn't bother me) to 4 (it bothers me a lot). The symptom bother score ranges from 0 to 80. Last observation carried forward (LOCF) was used as primary method of analysis. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to Week 48|ITT-E Population||Scores on a scale||Standard Deviation|Mean
857008|NCT02422797|Secondary|Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class|Blood samples were collected at Baseline (Day 1), 24 and 48 to assess fasting lipids which included total cholesterol (CHO), LDL cholesterol, HDL cholesterol and triglycerides. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 48|Safety Population||mmol/ L||Standard Deviation|Mean
857009|NCT02422797|Secondary|Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class|For all participants who meet virologic withdrawal criteria, plasma samples with HIV-1 RNA level >=200 c/mL were to be analyzed in an attempt to obtain phenotype data on as many samples as possible. Samples for drug resistance testing (phenotypic) were to be collected at Day 1. Number of participants with phenotypic resistance to CAR and to DTG or RPV for those meeting virologic withdrawal criteria in subgroups stratified based on Baseline third agent treatment class (INSTI, NNRTI, PI) were to be summarized. This outcome was not analyzed as the number of participants was low (1 CVW per arm) and summaries by Baseline third agent were not provided. Therefore, data are not available for this outcome measure due to the insufficient number of participants with events.|Week 48|CVW Population|||||
857010|NCT02422797|Secondary|Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class|For all participants who meet virologic withdrawal criteria, plasma samples with HIV-1 RNA level >=200 c/mL were to be analyzed in an attempt to obtain genotype data on as many samples as possible. Samples for drug resistance testing (genotypic) were to be collected at Day 1. Number of participants with genotypic resistance to CAR and to DTG or RPV for those meeting virologic withdrawal criteria in subgroups stratified based on Baseline third agent treatment class (INSTI, NNRTI, PI) were to be summarized. This outcome has not been analyzed as the number of participants was low (1 CVW per arm) and summaries by Baseline third agent were not provided. Therefore, data are not available for this outcome measure due to the insufficient number of participants with events.|Week 48|CVW Population|||||
857011|NCT02422797|Secondary|Number of Participants With Maximum Post-baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class|Blood samples were collected at Baseline (Day 1) and at Week 4, 8, 12, 24, 36 and 48 to evaluate hemoglobin, hematocrit, basophils, eosinophils, lymphocytes, monocytes, neutrophils, MCV, RBC count, WBC count and platelet count. Change from Baseline was calculated as value at indicated time point minus Baseline value. Number of participants who experienced maximum toxicity grade post-baseline in hematology parameters over 48 weeks by Baseline third agent treatment class (INSTI, NNRTI, PI) was summarized.|Up to 48 weeks|Safety Population||Participants|||Number
857012|NCT02422797|Secondary|Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class|Blood samples were collected at Baseline (Day 1) and at Week 4, 8, 12, 24, 36 and 48 to evaluate ALT, albumin, ALP, AST, total bilirubin, chloride, creatinine, glucose, potassium, phosphate, sodium, BUN, total carbon dioxide, lipase, creatine phosphokinase and creatinine clearance. Change from Baseline was calculated as value at indicated time point minus Baseline value. Number of participants who experienced maximum toxicity grade post-baseline in chemistry parameters over 48 weeks by Baseline third agent treatment class (INSTI, NNRTI, PI) was summarized.|Up to 48 weeks|Safety Population||Participants|||Number
857013|NCT02422797|Secondary|Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants with any AE, AELD or AE with maximum grade toxicity experienced by any one participant over 48 weeks by Baseline third agent class (INSTI, NNRTI, or PI) was summarized. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to 48 weeks|Safety Population||Participants|||Number
857014|NCT02422797|Secondary|Changes From Baseline in Cluster Designation (CD)4+ Lymphocyte Count at Week 48 by Baseline Third Agent Treatment Class|Blood for CD4 cell count assessment by flow cytometery was carried out at Baseline (Day 1), Week 4, 8, 12, 24, 36 and 48 to assess the impact of Baseline third agent class (INSTI, NNRTI, or PI) on efficacy, safety and tolerability of DTG +RPV compared to continuation of CAR. The full set of lymphocyte sub sets was not evaluated. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 48|ITT-E Population||Cells per mm^3||Standard Deviation|Mean
857015|NCT02422797|Secondary|Percentage of Participants With Plasma HIV 1 RNA <50 c/mL at Week 48 Using Snapshot Algorithm by Baseline Third Agent Treatment Class|Percentage of participants with plasma HIV 1 RNA < 50 c/mL at Week 48 using the FDA snapshot algorithm was assessed by Baseline third agent class to assess the impact of Baseline third agent class (INSTI, NNRTI, or PI) on efficacy, safety and tolerability of DTG +RPV compared to continuation of CAR. Plasma samples were collected for HIV-1 RNA at Baseline (Day 1), Week 4, 8, 12, 24, 36 and 48. The analysis was done using cochran-mantel haenszel test stratified by current antiretroviral third-agent class. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to Week 48|ITT-E Population||Percentage of participants|||Number
857016|NCT02422797|Secondary|Pre-dose Concentrations of DTG and RPV at Weeks 2, 4 and 8 in the First 20 Participants Who Switch From Efavirenz (EFV) or Nevirapine (NVP) to DTG + RPV|Two blood samples were collected pre-dose for DTG and RPV at Weeks 2 and 8 only for the first 20 participants who switch from EFV or NVP to DTG+RPV, in addition to the pre-dose blood sample collected at Week 4 for all subjects. One blood sample was collected pre-dose for EFV or NVP at Week 2 for the first 20 participants who switch from EFV or NVP to DTG + RPV. PK Parameter NNRTI Subset Extra Sampling Population consisted of the first approximately 20 participants in the PK Parameter NNRTI Subset population who have extra PK samples at weeks 2 and 8. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Pre-dose at Week 2, 4 and 8|PK Parameter NNRTI Subset extra sampling Population||ug/ L||Standard Deviation|Mean
857017|NCT02422797|Secondary|Pre-dose Concentrations of DTG and RPV at Weeks 4, 24 and 48 or Withdrawal in Participants Switching to DTG + RPV|Two separate blood samples for DTG and RPV were collected pre-dose at Weeks 4, 24 and 48. Pre-dose concentrations of DTG and RPV at Weeks 4, 24 and 48 or withdrawal were summarized for the participants switching to DTG + RPV in the early switch phase. Pharmacokinetic (PK) Parameter Population consisted of all participants who received DTG +RPV and provided at least one evaluable estimate of predose concentration (C0). Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Pre-dose at Week 4, 24 and 48 or at withdrawal visit|PK Parameter Population||ug/ L||Standard Deviation|Mean
857018|NCT02422797|Secondary|Phenotypic Resistance Data for Drugs Received for Participants Meeting Confirmed Virologic Withdrawal Criteria|Phenotypic resistance data for drugs received for participants meeting confirmed virologic withdrawal criteria are presented below. Confirmed Virologic Withdrawal (CVW) Population consisted of all participants in the ITT-E Population who met CVW (1 CVW per arm). NA indicates Not applicable based on drugs were not received. Phenotypic Resistance Data only shown for Drugs Received for Participants Meeting Confirmed Virologic Withdrawal Criteria.|Week 48|CVW Population||Participants|||Number
857019|NCT02422797|Secondary|Genotypic Resistance Data for Drugs Received for Participants Meeting Confirmed Virologic Withdrawal Criteria|Genotypic resistance data for drugs received for participants meeting confirmed virologic withdrawal criteria are presented below. Confirmed Virologic Withdrawal (CVW) Population consisted of all participants in the ITT-E Population who met CVW (1 CVW per arm). NA indicates Not applicable based on drugs were not received. Genotypic Resistance Data only shown for Drugs Received for Participants Meeting Confirmed Virologic Withdrawal Criteria.|Week 48|CVW Population||Participants|||Number
857020|NCT02422797|Secondary|Mean Change From Baseline in Fasting Lipids at Weeks 24 and 48|Blood samples were collected at Baseline (Day 1), Week 24 and Week 48 to assess fasting lipids which included total cholesterol, low density lipoprotein (LDL) cholesterol, high density lipoprotein (HDL) cholesterol and triglycerides. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to Week 48|Safety Population||Millimoles (mmol)/ L||Standard Deviation|Mean
857021|NCT02422797|Secondary|Mean Change From Baseline in Insulin Resistance Based on Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) at Week 48|Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess insulin resistance. Change from Baseline was calculated as value at indicated time point minus Baseline value. The homeostatic model assessment (HOMA) of insulin resistance (HOMA-IR ) index , the product of basal glucose and insulin levels divided by 22.5, is regarded as a simple , inexpensive , and reliable surrogate measure of insulin resistance.|Up to Week 48|Safety Population||HOMA-IR Score||Standard Deviation|Mean
857022|NCT02422797|Secondary|Mean Change From Baseline in Interleukin 6 (IL-6) at Week 48|Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess IL-6. Change from Baseline was calculated as value at indicated time point minus Baseline value.|Up to Week 48|Safety Population||Nanograms (ng)/L||Standard Deviation|Mean
857023|NCT02422797|Secondary|Mean Change From Baseline in Bone-specific Alkaline Phosphatase, Procollagen 1 N-terminal Propeptide, Osteocalcin, Type 1 Collagen C-telopeptides and Soluble Vascular Cell Adhesion Molecule (sVCAM) at Week 48|Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess bone-specific alkaline phosphatase, procollagen 1 N-terminal propeptide, osteocalcin, Type 1 Collagen C-telopeptides and sVCAM. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles). For bone-specific alkaline phosphatase, procollagen 1-N-propeptide, osteocalcin and type 1 collagen C-telopeptide, analyses of changes from Baseline were performed on log-transformed data. Results were transformed back via exponential transformation such that treatment comparisons are assessed via odds ratios.|Up to Week 48|Safety Population||Microgram (ug)/ L||Standard Deviation|Mean
857024|NCT02422797|Secondary|Mean Change From Baseline in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio at Week 48|Urine biomarker samples were collected at Baseline (Day 1) and Week 48 to assess urine albumin/creatinine ratio and urine protein/creatinine ratio. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to Week 48|Safety Population||Grams (g)/ mol||Standard Deviation|Mean
857025|NCT02422797|Secondary|Mean Change From Baseline in Beta-2-microglobulin (B2M) (Blood and Urine), Urine RBP and 25 Hydroxy-vitamin D at Week 48|Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess B2M and 25 hydroxy-vitamin D. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles). For 25 hydroxy-vitamin D, analysis of changes from Baseline was performed on log-transformed data. Results were transformed back via exponential transformation such that treatment comparisons are assessed via odds ratios.|Up to Week 48|Safety Population||Nanomoles (nmol)/ L||Standard Deviation|Mean
857026|NCT02422797|Secondary|Mean Change From Baseline in Urine Phosphate at Week 48|Urine biomarker samples were collected to at Baseline (Day 1) and Week 48 to assess urine phosphate. Change from Baseline was calculated as value at indicated time point minus Baseline value.|Up to Week 48|Safety Population||Millimoles (mmol)/ L||Standard Deviation|Mean
857027|NCT02422797|Secondary|Mean Change From Baseline in Retinol Binding Protein (RBP), Serum Creatinine and Glucose at Week 48|Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess RBP, serum creatinine and glucose. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to Week 48|Safety Population||mg/ deciliter (dL)||Standard Deviation|Mean
857028|NCT02422797|Secondary|Mean Change From Baseline in Soluble CD163 and Oxidized Low Density Lipoprotein (LDL) at Week 48|Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess soluble CD163 and oxidized LDL. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to Week 48|Safety Population||Microgram/Liter||Standard Deviation|Mean
857029|NCT02422797|Secondary|Mean Change From Baseline in Fatty Acid Binding Protein 2 (FABP) and Soluble CD14 at Week 48|Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess FABP and soluble CD14. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to Week 48|Safety Population||Nanogram/milliliter||Standard Deviation|Mean
857030|NCT02422797|Secondary|Mean Change From Baseline in D-Dimer at Week 48|Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess D-Dimer. Change from Baseline was calculated as value at indicated time point minus Baseline value.|Up to Week 48|Safety Population||Nanomole (nmol)/L FEU||Standard Deviation|Mean
857031|NCT02422797|Secondary|Mean Change From Baseline in Cystatin C at Week 48|Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess cystatin C. Change from Baseline was calculated as value at indicated time point minus Baseline value.|Up to Week 48|Safety Population||mg/L||Standard Deviation|Mean
857032|NCT02422797|Secondary|Mean Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 48|Blood biomarker samples were collected at Baseline (Day 1) and 48 to assess hs-CRP. Change from Baseline was calculated as value at indicated time point minus Baseline value.|Up to Week 48|Safety Population||mg/ Liter (L)||Standard Deviation|Mean
857033|NCT02422797|Secondary|Number of Participants With Maximum Post-baseline Emergent Hematology Toxicities Over 48 Weeks|Blood samples were collected at Baseline (Day 1) and at Week 4, 8, 12, 24, 36 and 48 to evaluate hemoglobin, hematocrit, basophils, eosinophils, lymphocytes, monocytes, neutrophils, mean corpuscular volume (MCV), red blood cell (RBC) count, white blood cell (WBC) count and platelet count. Change from Baseline was calculated as value at indicated time point minus Baseline value. Number of participants who experienced maximum grade toxicity post-baseline in hematology over 48 weeks was summarized.|Up to 48 weeks|Safety Population||Participants|||Number
857034|NCT02422797|Secondary|Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks|Blood samples were collected at Baseline (Day 1) and at Week 4, 8, 12, 24, 36 and 48 to evaluate alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), total bilirubin, chloride, creatinine, glucose, potassium, phosphate, sodium, blood urea nitrogen (BUN), total carbon dioxide, lipase, creatine phosphokinase and creatinine clearance. Value obtained at Day 1 was considered as Baseline value. Change from Baseline was calculated as value at indicated time point minus Baseline value. Number of participants who experienced maximum grade toxicity post-baseline in clinical chemistry over 48 weeks was summarized. Participants were graded using the Division of AIDS Table for Grading Severity of Adult and Pediatric Adverse Events. Grade 1=mild; grade and grade 4=potentially life-threatening. For all laboratory parameters, one assessment out of range was sufficient to be considered a chemistry toxicity.|Up to 48 weeks|Safety Population||Participants|||Number
857035|NCT02422797|Secondary|Number of Participants With Common Non-serious Adverse Event (AE), Any Serious AE (SAE), AE of Maximum Toxicity Grade 1, 2, 3 or 4 and AE Leading to Discontinuation (AELD)|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention were categorized as SAE. Number of participants with common non-serious AE, SAE, drug related AE or SAE, AELD or AE with maximum grade toxicity was summarized. Common AEs were those with >5 percent incidence for either treatment. Safety Population included all randomly assigned participants who have received at least one dose of study drug.|Up to Week 52|Safety Population||Participants|||Number
857036|NCT02422797|Secondary|Percentage of Participants With Plasma HIV 1 RNA <50 c/mL at Week 24 Using Snapshot Algorithm|Percentage of participants with plasma HIV 1 RNA < 50 c/mL at Week 24 using the FDA snapshot algorithm was assessed to evaluate the antiviral activity of DTG +RPV once daily compared to continuation of CAR. Virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the window of the visit of interest. Plasma samples were collected for HIV-1 RNA at Baseline(Day 1), Week 4, 8, 12 and 24.|Week 24|ITT-E Population||Percentage of participants|||Number
857037|NCT02422797|Secondary|Changes From Baseline in Cluster Designation (CD)4+ Lymphocyte Count at Weeks 24 and 48|Blood was collected and CD4+ cell count assessment by flow cytometery was carried out at Baseline (Day 1), Week 4, 8, 12, 24, 36 and 48 to evaluate the immunological activity of DTG + RPV once daily compared to continuation of CAR. The full set of lymphocyte sub sets was not evaluated. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Week 24 and 48|ITT-E Population||Cells per millimeter (mm)^3||Standard Deviation|Mean
857059|NCT02255097|Secondary|OS in Strong PD-L1-Positive Participants|Participants with a strong PD L-1 expression status were evaluated for OS. The expression of PD L-1 was determined by IHC and strong PD-L1 positive was defined as a PD-L1 tumor proportion score ≥50% by IHC. OS was defined as the time from the first day of study treatment to death due to any cause. OS was analyzed by the Kaplan-Meier method for censored data and reported in months.|Up to 3 years|All participants who received at least one dose of study medication with a Tumor Proportion Score ≥50%||Months||95% Confidence Interval|Median
857038|NCT02422797|Primary|Percentage of Participants With Plasma Human Immunodeficiency Virus (HIV) 1 Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) at Week 48 Using Snapshot Algorithm|Percentage of participants with plasma HIV 1 RNA < 50 c/mL at Week 48 using the Food and Drug Administration (FDA) snapshot algorithm was assessed to demonstrate the non-inferior antiviral activity of switching to DTG+RPV once daily compared to continuation of CAR over 48 weeks in HIV-1 infected antiretroviral therapy (ART)-experienced participants. Virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the window of the visit of interest. Plasma samples were collected for HIV-1 RNA at Week 0 (Day 1), Week 4, 8, 12, 24, 36 and 48. Treatment with DTG + RPV were declared non-inferior to CAR if the lower end of a two-sided 95% confidence interval for the difference between the two groups in response rates at Week 48 lies above -10% by Cochran-Mantel Haenszel test. The Intent-to-Treat Exposed (ITT-E) population consisted of all randomly assigned participants who received at least one dose of study drug.|Week 48.|ITT-E Population||Percentage of participants|||Number
857048|NCT02302716|Secondary|Percentage of Participants With Hypoglycemic Events|The percentage of participants (with at least 1 hypoglycemic event (total, severe, nocturnal, and others) or incidence during the study was analyzed using Fisher's exact test. A hypoglycemic event is defined as any time a participant has a blood glucose (BG) level of ≤70 milligrams per deciliter (mg/dL) even if the event was not associated with signs, symptoms, or treatment consistent with current guidelines (American Diabetes Association 2005). Nocturnal hypoglycemia is defined as any hypoglycemic event that occurs between bedtime and waking. Severe hypoglycemia is defined as a hypoglycemic event requiring assistance of another person to actively administer carbohydrates, glucagons, or other resuscitative actions. Severe Hypoglycemic events may or may not have a reported BG ≤70 mg/dL. These events may be associated with sufficient neuroglycopenia to induce seizure or coma.|Endpoint [up to 24 weeks]|All randomized participants who had a post-baseline measurement for Hypoglycemic Events; last observation carried forward (LOCF).||Percentage of participants|||Number
857116|NCT02147184|Primary|Osteocalcin to C-terminal Telopeptide Ratio|Osteocalcin (ng/mL) is a bone formation marker and C-terminal telopeptide (ng/mL) a marker of bone resorption.|At baseline and every 4 months up to 2 years.|The figures below may be lower based on availability of serum, performance of the assay, and premature attrition.||Ratio||Standard Deviation|Mean
857049|NCT02302716|Secondary|Rate of Hypoglycemic Events Adjusted Per 1 Year|The rate of hypoglycemic events were analyzed at baseline, titration, maintenance, and overall study periods and at endpoint using the Wilcoxon test. In addition, a negative binomial model was used as a sensitivity analysis. A hypoglycemic event is defined as any time a participant has a blood glucose (BG) level of ≤70 milligrams per deciliter (mg/dL) even if the event was not associated with signs, symptoms, or treatment consistent with current guidelines (American Diabetes Association 2005). Nocturnal hypoglycemia is defined as any hypoglycemic event that occurs between bedtime and waking. Severe hypoglycemia is defined as a hypoglycemic event requiring assistance of another person to actively administer carbohydrates, glucagons, or other resuscitative actions. Severe Hypoglycemic events may or may not have a reported BG ≤70 mg/dL. These events may be associated with sufficient neuroglycopenia to induce seizure or coma.|Baseline through Endpoint [up to 24 weeks]|All randomized participants who received at 1 dose of study drug with Baseline at least 1 post-Baseline hypoglycemic event; last observation carried forward (LOCF).||Hypoglycemic events per 1 year||Standard Deviation|Mean
857050|NCT02302716|Secondary|Percentage of Participants With Detectable Anti-Drug Antibodies to LY2963016 or LANTUS®|The percentage of participants with detected insulin antibodies were summarized as counts and percentages at baseline, at each visit, at the 24-week endpoint (LOCF), and overall for the 24-week treatment period.|Endpoint [up to 24 weeks]|All randomized participants who received at least 1 dose of study drug and with a Baseline and at least 1 post-Baseline with detectable anti-drug antibodies; last observation carried forward (LOCF).||Percentage of participants|||Number
857051|NCT02302716|Secondary|Insulin Treatment Satisfaction Questionnaire (ITSQ) Score|ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. Items divided into 5 domains of satisfaction: Inconvenience of Regimen [(IR) 5 items: domain scores range (DSR) 5-35], Lifestyle Flexibility [(LF) 3 items: DSR 3-21], Glycemic Control [(GC) 3 items: DSR 3-21], Hypoglycemic Control [(HC) 5 items: DSR 5-35], Insulin Delivery Device [(IDD) 6 items: DSR 6-42]. All items measured on a 7-point scale: 1 (no bother at all) to 7 (a tremendous bother), with lower scores reflecting better outcomes. ITSQ Total Overall Raw Scores range from 22-154. Both raw domain and overall scores are transformed on a scale of 0-100, where transformed score=100*[(7-mean raw score)/6]. Higher scores indicate better treatment satisfaction. LS means was determined by MMRM with baseline of response, baseline HbA1c, country, sulfonylurea use, basal insulin status at study entry, visit, treatment and visit*treatment in the model.|Week 4 and Week 24|All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline ITSQ measure.||units on a scale||Standard Error|Least Squares Mean
857052|NCT02302716|Secondary|Change From Baseline to 24 Weeks in Body Weight|Change from baseline in body weight. Least Squares (LS) means was determined by mixed model repeated measures (MMRM) methodology with baseline of response, baseline HbA1c, country, sulfonylurea use, basal insulin status at study entry, visit, treatment and visit*treatment in the model.|Baseline, 24 Weeks|All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline body weight measure.||Kilogram (kg)||Standard Error|Least Squares Mean
857053|NCT02302716|Secondary|Basal Insulin Dose Per Body Weight (U/kg/Day)|Basal Insulin dose in units (U) per body weight in kilograms (kg) per day. Least Squares (LS) means was determined by mixed model repeated measures (MMRM) methodology with baseline of response, baseline HbA1c, country, sulfonylurea use, basal insulin status at study entry, visit, treatment and visit*treatment in the model.|Week 24|All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline Basal Insulin Dose per Body Weight measure.||units per kilogram per day (U/kg/day)||Standard Error|Least Squares Mean
857054|NCT02302716|Secondary|Basal Insulin Dose Units Per Day|Units of Basal Insulin dose taken per day (U/day). Least Squares (LS) means was determined by mixed model repeated measures (MMRM) methodology with baseline of response, baseline HbA1c, country, sulfonylurea use, basal insulin status at study entry, visit, treatment and visit*treatment in the model.|Week 24|All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline Basal Insulin Dose.||Units per day (U/day)||Standard Error|Least Squares Mean
857055|NCT02302716|Secondary|Intra-Participant Variability in Fasting Blood Glucose (FBG)|Fasting blood glucose (FBG) is a test to determine how much glucose (sugar) is in a blood sample after an overnight fast. Intra-Participant FBG variability was calculated based on the standard deviation (SD) of the morning pre-meal BG value. Least Squares (LS) means was determined by mixed model repeated measures (MMRM) methodology with baseline HbA1c, country, sulfonylurea use, basal insulin status at study entry, visit, treatment and visit*treatment in the model.|Week 24|All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline fasting blood glucose measure.||mmol/L||Standard Error|Least Squares Mean
857056|NCT02302716|Secondary|Change From Baseline in 7-point Self-Monitored Blood Glucose (SMBG) Values|Seven-point SMBG are completed at the following timepoints: Before Morning Meal, 2 Hours After Morning Meal, Before Mid-Day Meal, 2 Hours After Mid-Day Meal, Before Evening Meal, Bed Time and 03:00 AM hours. Least Squares (LS) means was determined by mixed model repeated measures (MMRM) methodology with baseline HbA1c, country, sulfonylurea use, basal insulin status at study entry, visit, treatment and visit*treatment in the model.|Baseline, Week 24|All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline SMBG measure.||Millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
857057|NCT02302716|Secondary|Percentage of Participants With HbA1c <7% and ≤6.5%|Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time.|Endpoint [up to 24 weeks]|All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline HbA1c measure; last observation carried forward (LOCF).||Percentage of participants|||Number
857058|NCT02302716|Primary|Change From Baseline to 24 Weeks in Hemoglobin A1c (HbA1c)|"HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time.
Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with baseline of response, treatment (LY2963016, LANTUS), pooled country, basal insulin at entry (yes/no), sulfonylurea (SU) use (yes/no), visit, treatment and visit*treatment in the model."|Baseline, 24 weeks|All randomized participants who received at least 1 dose of study drug and with a Baseline and at least 1 post-Baseline HbA1c measure.||Percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
857060|NCT02255097|Secondary|OS in PD-L1-Positive Participants|Participants with a positive PD L-1 expression status were evaluated for OS. The expression of PD L-1 was determined by IHC and PD-L1 positive was defined as a PD-L1 tumor proportion score ≥1% by IHC. OS was defined as the time from the first day of study treatment to death due to any cause. OS was analyzed by the Kaplan-Meier method for censored data and reported in months.|Up to 3 years|All participants who received at least one dose of study medication with a Tumor Proportion Score ≥1%||Months||95% Confidence Interval|Median
857061|NCT02255097|Secondary|Overall Survival (OS) in All Participants|OS was defined as the time from the first day of study treatment to death due to any cause. OS was analyzed by the Kaplan-Meier method for censored data and reported in months.|Up to 3 years|All participants who received at least one dose of study medication||Months||95% Confidence Interval|Median
857062|NCT02255097|Secondary|PFS in Strong PD-L1-Positive Participants|Participants with a strong PD L-1 expression status were evaluated for PFS by modified RECIST 1.1. The expression of PD L-1 was determined by IHC and strong PD-L1 positive was defined as a PD-L1 tumor proportion score ≥50% by IHC. PFS was defined as the time from the first day of study treatment to the first documented PD per RECIST 1.1 or death due to any cause, whichever occurred first. Using RECIST 1.1, PD was defined as either a 20% relative increase in the sum of diameters of target lesions, taking as reference the smallest sum on study OR an absolute increase of >5 mm the sum of lesions, OR the appearance of new lesions. PFS was analyzed by the Kaplan-Meier method for censored data and reported in months.|Up to 3 years|All participants who received at least one dose of study medication with a Tumor Proportion Score ≥50%||Months||95% Confidence Interval|Median
857063|NCT02255097|Secondary|PFS in PD-L1-Positive Participants|Participants with a positive PD L-1 expression status were evaluated for PFS. The expression of PD L-1 was determined by IHC and PD-L1 positive was defined as a PD-L1 tumor proportion score ≥1% by IHC. PFS was defined as the time from the first day of study treatment to the first documented PD per RECIST 1.1 or death due to any cause, whichever occurred first. Using RECIST 1.1, PD was defined as either a 20% relative increase in the sum of diameters of target lesions, taking as reference the smallest sum on study OR an absolute increase of >5 mm the sum of lesions, OR the appearance of new lesions. PFS was analyzed by the Kaplan-Meier method for censored data and reported in months.|Up to 3 years|All participants who received at least one dose of study medication with a Tumor Proportion Score ≥1%||Months||95% Confidence Interval|Median
857064|NCT02255097|Secondary|Progression-free Survival (PFS) in All Participants|PFS was defined as the time from the first day of study treatment to the first documented PD per RECIST 1.1 or death due to any cause, whichever occurred first. Using RECIST 1.1, PD was defined as either a 20% relative increase in the sum of diameters of target lesions, taking as reference the smallest sum on study OR an absolute increase of >5 mm the sum of lesions, OR the appearance of new lesions. PFS was analyzed by the Kaplan-Meier method for censored data and reported in months.|Up to 3 years|All participants who received at least one dose of study medication||Months||95% Confidence Interval|Median
857065|NCT02255097|Secondary|DOR in Strong PD-L1-Positive Participants|Participants with a strong PD L-1 expression status were evaluated for DOR based n RECIST 1.1. The expression of PD L-1 was determined by IHC and strong PD-L1 positive was defined as a PD-L1 tumor proportion score ≥50% by IHC. DOR was measured from the time measurement criteria were first met for CR/PR (whichever was first recorded) until the first date that recurrent or PD was objectively documented (taking as reference for PD the smallest measurements recorded on study). DOR was censored at the last tumor assessment date if a responder did not have PD or death. Non-responders were not included in the analysis. The lower and upper limits were estimated at the time of data cutoff. DOR was analyzed by the Kaplan-Meier method for censored data and reported in months.|Up to 3 years|All participants who received at least one dose of study medication with a Tumor Proportion Score ≥50% and a best overall response as confirmed complete response or partial response||Months||Full Range|Median
857066|NCT02255097|Secondary|DOR in PD-L1-Positive Participants|Participants with a positive PD L-1 expression status were evaluated for DOR based on RECIST 1.1. The expression of PD L-1 was determined by IHC and PD-L1 positive was defined as a PD-L1 tumor proportion score ≥1% by IHC. DOR was measured from the time measurement criteria were first met for CR/PR (whichever was first recorded) until the first date that recurrent or PD was objectively documented (taking as reference for PD the smallest measurements recorded on study). DOR was censored at the last tumor assessment date if a responder did not have PD or death. Non-responders were not included in the analysis. The lower and upper limits were estimated at the time of data cutoff. DOR was analyzed by the Kaplan-Meier method for censored data and reported in months.|Up to 3 years|All participants who received at least one dose of study medication with a Tumor Proportion Score ≥1% and a best overall response as confirmed complete response or partial response||Months||Full Range|Median
857067|NCT02255097|Secondary|Response Duration (DOR) in All Participants|DOR was based on RECIST 1.1 and measured from the time measurement criteria were first met for CR/PR (whichever was first recorded) until the first date that recurrent or PD was objectively documented (taking as reference for PD the smallest measurements recorded on study). DOR was censored at the last tumor assessment date if a responder did not have PD or death. Non-responders were not included in the analysis. The lower and upper limits were estimated at the time of data cutoff. DOR was analyzed by the Kaplan-Meier method for censored data and reported in months.|Up to 3 years|All participants who received at least one dose of study medication with a best overall response as confirmed complete response or partial response||Months||Full Range|Median
857068|NCT02255097|Secondary|ORR by Modified RECIST Version 1.1 in Strong PD-L1-Positive Participants|Participants with a strong PD L-1 expression status were evaluated for ORR by modified RECIST 1.1. The expression of PD L-1 was determined by IHC and strong PD-L1 positive was defined as a PD-L1 tumor proportion score ≥50% by IHC. ORR was assessed by performing study imaging every 6-9 weeks after the first dose of study treatment. ORR was defined as the proportion of participants in the analysis population who had a CR defined as a disappearance of all target lesions with pathological lymph nodes having a reduction in short axis to <10 mm) or PR defined as at least a 30% decrease in the sum of diameters of target lesions, using the baseline sum diameters as a reference. If imaging shows disease progression (PD) imaging was repeated 4 weeks later to confirm progression. PD was defined as at least a 20% increase in the sum of diameters of target lesions and new measurable lesions, taking as reference the smallest sum recorded since treatment started.|Up to 3 years|All participants who received at least one dose of study medication with a Tumor Proportion Score ≥50%||Percentage of participants||95% Confidence Interval|Number
857069|NCT02255097|Secondary|ORR by Modified RECIST Version 1.1 in PD-L1-Positive Participants|Participants with a positive PD L-1 expression status were evaluated for ORR by modified RECIST 1.1. The expression of PD L-1 was determined by IHC and PD-L1 positive was defined as a PD-L1 tumor proportion score ≥1% by IHC. ORR was assessed by performing study imaging every 6-9 weeks after the first dose of study treatment. ORR was defined as the proportion of participants in the analysis population who had a CR defined as a disappearance of all target lesions with pathological lymph nodes having a reduction in short axis to <10 mm) or PR defined as at least a 30% decrease in the sum of diameters of target lesions, using the baseline sum diameters as a reference. If imaging shows disease progression (PD) imaging was repeated 4 weeks later to confirm progression. PD was defined as at least a 20% increase in the sum of diameters of target lesions and new measurable lesions, taking as reference the smallest sum recorded since treatment started.|Up to 3 years|All participants who received at least one dose of study medication with a Tumor Proportion Score ≥1%||Percentage of participants||95% Confidence Interval|Number
857070|NCT02255097|Secondary|ORR by Modified RECIST Version 1.1 in All Participants|ORR was assessed by modified RECIST 1.1 by performing study imaging every 6-9 weeks after the first dose of study treatment. ORR was defined as the proportion of participants in the analysis population who had a CR defined as a disappearance of all target lesions with pathological lymph nodes having a reduction in short axis to <10 mm) or PR defined as at least a 30% decrease in the sum of diameters of target lesions, using the baseline sum diameters as a reference. If imaging shows disease progression (PD) imaging was repeated 4 weeks later to confirm progression. PD was defined as at least a 20% increase in the sum of diameters of target lesions and new measurable lesions, taking as reference the smallest sum recorded since treatment started.|Up to 3 years|All participants who received at least one dose of study medication||Percentage of participants||95% Confidence Interval|Number
857071|NCT02255097|Secondary|ORR by RECIST Version 1.1 in Human Papilloma Virus (HPV)-Positive Tumors|Participants with a HPV-positive tumor biopsy were evaluated for ORR by RECIST 1.1. ORR was assessed by performing study imaging every 6-9 weeks after the first dose of study treatment. ORR was defined as the proportion of participants in the analysis population who had a CR defined as a disappearance of all target lesions with pathological lymph nodes having a reduction in short axis to <10 mm) or PR defined as at least a 30% decrease in the sum of diameters of target lesions, using the baseline sum diameters as a reference.|Up to 3 years|All participants who received at least one dose of study medication with a HPV-positive tumor||Percentage of participants||95% Confidence Interval|Number
857072|NCT02255097|Secondary|ORR by RECIST 1.1 in PD-L1-Positive Participants|Participants with a positive PD L-1 expression status were evaluated for ORR by RECIST 1.1. The expression of PD L-1 was determined by IHC and PD-L1 positive was defined as a PD-L1 tumor proportion score ≥1% by IHC. ORR was assessed by performing study imaging every 6-9 weeks after the first dose of study treatment. ORR was defined as the proportion of participants in the analysis population who had a CR defined as a disappearance of all target lesions with pathological lymph nodes having a reduction in short axis to <10 mm) or PR defined as at least a 30% decrease in the sum of diameters of target lesions, using the baseline sum diameters as a reference.|Up to 3 years|All participants who received at least one dose of study medication with a Tumor Proportion Score ≥1%||Percentage of participants||95% Confidence Interval|Number
857073|NCT02255097|Primary|Number of Participants Discontinuing Study Drug Due to an AE|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol-specified procedure, whether or not considered related to the medicinal product/protocol-specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE. A serious adverse event (SAE) was an AE that resulted in death, was life threatening, resulted in persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a cancer, was associated with an overdose, was another important medical event.|From first dose to last dose of treatment; up to 25 months|All participants who received at least one dose of study medication||Participants|||Number
857074|NCT02255097|Primary|Number of Participants Experiencing an Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol-specified procedure, whether or not considered related to the medicinal product/protocol-specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE. A serious adverse event (SAE) was an AE that resulted in death, was life threatening, resulted in persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a cancer, was associated with an overdose, was another important medical event.|From first dose to last dose of treatment plus 2 months of follow-up, up to 27 months|All participants who received at least one dose of study medication||Participants|||Number
857075|NCT02255097|Primary|ORR by RECIST Version 1.1 in Strong Programmed Cell Death Ligand 1 (PD-L1)-Positive Participants|Participants with a strong PD L-1 expression status were evaluated for ORR by RECIST 1.1. The expression of PD L-1 was determined by immunohistochemistry (IHC) and strong PD-L1 positive was defined as a PD-L1 tumor proportion score ≥50% by IHC. ORR was assessed by performing study imaging every 6-9 weeks after the first dose of study treatment. ORR was defined as the proportion of participants in the analysis population who had a CR defined as a disappearance of all target lesions with pathological lymph nodes having a reduction in short axis to <10 mm) or PR defined as at least a 30% decrease in the sum of diameters of target lesions, using the baseline sum diameters as a reference.|Up to 3 years|All participants who received at least one dose of study medication with a Tumor Proportion Score ≥50%||Percentage of participants||95% Confidence Interval|Number
857076|NCT02255097|Primary|Overall Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants|ORR was assessed by RECIST 1.1 by performing study imaging every 6-9 weeks after the first dose of study treatment. ORR was defined as the proportion of participants in the analysis population who had a Complete Response (CR) defined as a disappearance of all target lesions with pathological lymph nodes having a reduction in short axis to <10 mm) or Partial Response (PR) defined as at least a 30% decrease in the sum of diameters of target lesions, using the baseline sum diameters as a reference.|Up to 3 years|All participants who received at least one dose of study medication||Percentage of participants||95% Confidence Interval|Number
857078|NCT02229396|Secondary|Change in Systolic Blood Pressure From Baseline to Week 28|To compare the change from baseline to Week 28 in systolic blood pressure between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.|Baseline to Week 28|All randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.||mmHg||95% Confidence Interval|Least Squares Mean
857079|NCT02229396|Secondary|Percentage of Patients Achieving HbA1c <7% at Week 28|To compare the percentage of patients achieving HbA1c <7% at 28 weeks between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.|Baseline to Week 28|All randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.||% of patients||95% Confidence Interval|Number
857080|NCT02229396|Secondary|Change in Fasting Plasma Glucose From Baseline to Week 2|To compare the change from baseline to Week 2 in fasting plasma glucose between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.|Baseline to Week 2|All randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.||mg/dL||95% Confidence Interval|Least Squares Mean
857081|NCT02229396|Secondary|Percentage of Patients Achieving Weight Loss ≥5.0% at Week 28|To compare the percentage of patients achieving weight loss ≥5.0% at 28 weeks between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.|Baseline to Week 28|All randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.||% of patients||95% Confidence Interval|Number
857082|NCT02229396|Secondary|Change From Baseline to Week 28 in 2-hour Postprandial Glucose After a Standard Meal Tolerance Test|To compare the change from baseline to Week 28 in 2-hour postprandial glucose after a standard Meal Tolerance Test between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.|Baseline to Week 28|All randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.||mg/dL||95% Confidence Interval|Least Squares Mean
857083|NCT02229396|Secondary|Change in Fasting Plasma Glucose From Baseline to Week 28|To compare the change from baseline to Week 28 in fasting plasma glucose between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.|Baseline to Week 28|All randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment||mg/dL||95% Confidence Interval|Least Squares Mean
857084|NCT02229396|Secondary|Change in Body Weight From Baseline to Week 28|To compare the change from baseline to Week 28 in body weight between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.|Baseline to Week 28|All randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.||kg||95% Confidence Interval|Least Squares Mean
857085|NCT02229396|Primary|Change in HbA1c From Baseline to Week 28|To compare the change from baseline to Week 28 in HbA1c between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.|Baseline to Week 28|All randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.||% HbA1c||95% Confidence Interval|Least Squares Mean
857111|NCT02147184|Other Pre-specified|The Moderating Effect of the Short Allele of the Serotonin Transporter-Linked Polymorphic Region (5HTTLPR) Gene on the Association Between SSRI Use and the Primary Outcomes||2 years||12/2019||||
857112|NCT02147184|Secondary|Cortical Thickness at 20% Radius|This is cortical thickness as measured by pQCT.|At baseline and every 4 months up to 2 years.|The figures below may be lower than the overall numbers above due to exclusions for movement artifacts and premature drop outs.||mm||Standard Deviation|Mean
857113|NCT02147184|Secondary|Cortical Volumetric BMD at 20% Radius||At baseline and every 4 months up to 2 years.|This was the original sample size per group but the figures below reflect attrition and data exclusion due to movement artifacts.||mg/cm^3||Standard Deviation|Mean
857114|NCT02147184|Secondary|Lumbar Spine Bone Mineral Density (BMD) Z-score|This is a Z-score adjusted for sex, age, race, and height.|At baseline and every 8 months up to 2 years.|This was the initial sample size per group but the figures below reflect attrition or data excluded due to artifact.||Z-score (Age-Sex-Height-Race Specific)||Standard Deviation|Mean
857115|NCT02147184|Primary|Bone-specific Alkaline Phosphatase to C-terminal Telopeptide Ratio|Bone-specific alkaline phosphatase (ng/mL) is a marker of bone formation while C-terminal telopeptide (ng/mL) is a marker of bone resorption.|At baseline and every 4 months up to 2 years.|The figures below might be less than the stated numbers above depending on availability of serum samples, the performance of the assay, and premature attrition.||Ratio||Standard Deviation|Mean
857117|NCT02147184|Primary|Trabecular Volumetric Bone Mineral Density at the Ultradistal Radius|Volumetric bone mineral density (vBMD) at the nondominant radius (4% and 20% sites) was measured, at study entry and every four months, with peripheral quantitative computed tomography (pQCT), using a Stratec XCT‐2000 scanner (Stratec, Inc., Pforzheim, Germany). Image analysis was performed using the manufacturer’s software package, version 6.0. pQCT scans compromised by movement were rejected. Quality control and calibration of the equipment were performed daily.|At baseline and every 4 months up to 2 years.|This was the starting sample size. However, the figures below reflect participant attrition and exclusion of scans due to movement artifact.||mg/cm^3||Standard Deviation|Mean
857118|NCT02147184|Primary|Total Body Less Head Bone Mineral Content (TBLH BMC) Z-score (Adjusted for Age-sex-height-race)|Whole-body dual energy x-ray absorptiometry (DXA) scan was obtained using a Hologic QDR DELPHI-4500A unit or a Hologic Discovery A unit (Hologic, Inc, Bedford, MA). The two DXA units were cross-calibrated.|At baseline and every 8 months up to 2 years.|These are the starting sample size but the figures below reflect participant attrition.||Z score (age-sex-height-race specific)||Standard Deviation|Mean
857119|NCT02133508|Secondary|Percentage of Participants With Adverse Events (AEs)|An AE is an unfavorable and unintended sign, symptom, or disease temporally associated with a clinical study, regardless of causality.|Up to 8 months|All eligible participants||percentage of participants|||Number
857120|NCT02133508|Secondary|Overall Survival|Overall survival was defined as the time from the beginning of therapy with erlotinib to death from any cause.|Up to 8 months|All eligible participants||months||95% Confidence Interval|Median
857121|NCT02133508|Secondary|Progression-free Survival (PFS) According to RECIST v1.1|PFS was defined as the time from the beginning of therapy with erlotinib to the first occurrence of disease progression, as determined by the investigator using RECIST v1.1 criteria, or death from any cause. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.|Up to 8 months|All eligible participants||days||95% Confidence Interval|Median
857122|NCT02133508|Primary|Duration of SD or Objective Response According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1|The duration of SD or objective response (CR+PR) was defined as the time from first occurrence of SD or objective response to the time of PD, or death for any cause. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Objective response was defined as having a CR or PR. CR was defined as disappearance of all target and non-target lesions and no new lesions, and all pathological lymph nodes must have decreased to <10 mm in short axis. PR was defined as at least 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. PD was defined as at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and an absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.|Up to 8 months|All eligible participants||percentage of participants|||Number
857123|NCT02133508|Primary|Percentage of Participants With Stable Disease (SD) or Objective Response (Complete and Partial Response [CR + PR] According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1|SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. Objective response was defined as having a CR or PR. CR was defined as disappearance of all target and non-target lesions and no new lesions, and all pathological lymph nodes must have decreased to <10 millimeters (mm) in short axis. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. PD was defined as at least a 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and an absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.|Up to 8 months|All eligible participants||percentage of participants|||Number
857186|NCT01788358|Secondary|Blood Pressure Response Rate at Weeks 28 and 52|Response rate was defined as the percentage of subjects who achieved a systolic blood pressure response (MSSBP of <140 mmHg or a reduction of MSSBP of more than (>) 20 mmHg from baseline value), or a diastolic blood pressure response (MSDBP of <90 mmHg or a reduction of MSDBP of >10 mmHg from baseline value).|Weeks 28 and 52|mITT||percentage of subjects|||Number
857187|NCT01788358|Secondary|Blood Pressure Control Rate at Weeks 28 and 52|Control rate was defined as the percentage of subjects that reached a predetermined blood pressure (BP) target of BP less than (<) 140/90 mmHg.|Weeks 28 and 52|mITT||percentage of subjects|||Number
857188|NCT01788358|Secondary|Change From Baseline in Mean Seated Diastolic Blood Pressure (MSDBP) at Weeks 28 and 52||Baseline (Week 0), Weeks 28 and 52|mITT||millimeter of mercury (mmHg)||Standard Deviation|Mean
857189|NCT01788358|Secondary|Change From Baseline In Mean Seated Systolic Blood Pressure (MSSBP) At Weeks 28 And 52||Baseline (Week 0), Weeks 28 and 52|Modified intention-to-treat analysis set (mITT): All the subjects enrolled into the open-label treatment period and took at least one unit of the study medication.||millimeter of mercury (mmHg)||Standard Deviation|Mean
857190|NCT01788358|Secondary|Number of Subjects With Clinically Relevant Changes in Laboratory Parameters|Laboratory evaluations of blood and urine samples were performed, including hematology (hematocrit, hemoglobin, red blood cells count, white blood cells count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets), blood chemistry (sodium, potassium, chloride, bicarbonate, uric acid, total protein, albumin, calcium, blood urea nitrogen, creatinine, aspartate transaminase, alanine transaminase, lactate dehydrogenase, gamma glutamyl transferase, alkaline phosphatase, creatine kinase, total bilirubin, direct bilirubin, total cholesterol, low density lipoprotein cholesterol, high density lipoprotein cholesterol, triglycerides, fasting glucose), urinalysis (pH, blood, specific gravity, glucose, protein, cells/sediment). A laboratory test abnormality considered clinically relevant, for example, causing withdrawal by subject, requiring treatment or causing apparent clinical manifestations, or judged relevant by the investigator, were reported as AEs.|Baseline (Week 0) up to Week 52/EOS|SAF||Subjects|||Number
857191|NCT01788358|Primary|Number of Subjects With Treatment-emergent Adverse Events (TEAEs) of Special Interest up to Week 52/End of Study (EOS)|An AE is any untoward medical occurrence (that is, any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study. AEs were considered to be treatment-emergent if they had started or worsened after first application of study medication. TEAEs of special interest included the incidence of symptomatic hypotension and the incidence and severity of vasodilatory adverse events (such as oedema, headache, and flushing). Only subjects who had TEAEs of special interest as mild, moderate or severe were reported.|From the time of study treatment up to Week 52/EOS|SAF||Subjects|||Number
857192|NCT01788358|Primary|Number of Subjects With All Treatment-emergent Adverse Events (TEAEs) and Drug-related TEAEs up to Week 52/End of Study (EOS)|An AE is any untoward medical occurrence (that is, any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study. AEs were considered to be treatment-emergent if they had started or worsened after first application of study medication.|From the time of first study drug administration up to Week 52/EOS|SAF||Subjects|||Number
857193|NCT01788358|Primary|Number of Subjects With Treatment-emergent Adverse Events (TEAEs) of Special Interest up to Week 28|An AE is any untoward medical occurrence (that is, any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study. AEs were considered to be treatment-emergent if they had started or worsened after first application of study medication. TEAEs of special interest included the incidence of symptomatic hypotension and the incidence and severity of vasodilatory adverse events (such as oedema, headache, and flushing). Only subjects who had TEAEs of special interest as mild, moderate or severe were reported.|From the time of first study drug administration up to Week 28|SAF||Subjects|||Number
857194|NCT01788358|Primary|Number of Subjects With All Treatment-emergent Adverse Events (TEAEs) and Drug-related TEAEs up to Week 28|An adverse event (AE) is any untoward medical occurrence (that is, any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study. AEs were considered to be treatment-emergent if they had started or worsened after first application of study medication.|From the time of first study drug administration up to Week 28|Safety Analysis Set (SAF): All the subjects enrolled into the open-label treatment period and took at least one unit of the study medication.||Subjects|||Number
857229|NCT01692691|Secondary|Median Survival of Patients Treated With Combination.||8 weeks||||||
857230|NCT01692691|Secondary|Median Duration of Response||8 weeks||||||
857231|NCT01692691|Secondary|Response Rate||8 weeks|||percentage of participants||95% Confidence Interval|Number
857232|NCT01692691|Primary|Progression Free Survival of Patients With Stage IV Melanoma Who Have Had Disease Progression on at Least One Prior Systemic Therapy||8 weeks|||participants|||Number
857250|NCT01658813|Secondary|Median Survival|Median survival was measured from date of entry on study until date of death|up to 2 years|all 18 patients were analyzed.||months||Full Range|Median
857251|NCT01658813|Secondary|Median Duration of Response|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by radiographic imaging: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up tp 2 years|2 partial responses were seen.||months||Full Range|Median
857252|NCT01658813|Secondary|Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by radiographic imaging: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|up to 2 years|||percentage of patients responding||95% Confidence Interval|Number
857253|NCT01658813|Secondary|Number of Responses|Radiographic studies to evaluate for response were done at 8 weeks (after 1 cycle). Standard RECIST response criteria were utilized. Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|up to 2 years.|||number of patients responding|||Number
857254|NCT01658813|Primary|Progression Free Survival|Progression Free Survival (PFS) was calculated as the time (months) from date of the start of treatment to the date of first observed disease progression (per standard Response Evaluation Criteria In Solid Tumors [RECIST] or date of death from any cause, whichever came first, assessed up to 2 years. The actual date of tumor assessments was used for this calculation. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of one or more new lesions.|Assessed up tp 2 years|||months||Full Range|Median
857340|NCT01452529|Primary|"Mean Pain Intensity for Average Pain Over the Last 24 Hours Score"|"Mean pain intensity for average pain over the last 24 hours score (on an 11-point numerical rating scale where 0 = no pain and 10 = pain as bad as you can imagine)."|Week 12|The full analysis population (N = 588) was the group of subjects who were randomized and received at least 1 dose of double-blind study drug||units on a scale||Standard Error|Mean
857670|NCT00470366|Secondary|Progression-free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Up to 8 years|||years||Full Range|Median
857308|NCT01515189|Secondary|Overall Survival of Participants With Brain Metastases at Baseline|OS for each participant with brain metastases at baseline was measured as the time between randomization date and death due to any cause. The survival time for participants who had not died was censored at the last known alive date. Median OS, and associated 2-sided 95% confidence intervals were calculated using the Brookmeyer and Crowley method.|From date of randomization until 540 death events occurred (approximately 48 months)|All randomized participants with brain metastases at baseline||months||95% Confidence Interval|Median
857309|NCT01515189|Secondary|Rate of Overall Survival|OS is defined for each participant as the time between randomization date and death due to any cause. The survival time for participants who had not died was censored at the last known alive date. Survival rates were calculated based on Kaplan-Meier estimation with log-log transformed confidence intervals. The survival rate at x year(s) is defined as the probability that a subject is alive at x year(s) following randomization.|From date of randomization until 5 years (ongoing)|All randomized participants||percentage of participants||95% Confidence Interval|Number
857320|NCT01495988|Secondary|Overall Survival|Compare overall survival (OS) of patients with stage IV, BRAFV600E/K melanoma treated with vemurafenib/cobimetinib versus vemurafenib/cobimetinib and bevacizumab.|Time between randomization and death due to any cause (overall survival rates also to be assessed at 12 and 18 months)|The trial was terminated prematurely during the phase Ib safety lead-in and outcome measures were not analyzed due to significantly underpowered data and the MTD being undetermined.|||||
857310|NCT01515189|Secondary|Duration of Stable Disease by mWHO Criteria|Duration of stable disease was defined for participants whose BOR was SD as the time between when SD was first documented and the date of PD or death (whichever occurred first). For a participant who underwent tumor resection following Week 12 but prior to disease progression, duration of stable disease was censored on the date of the last evaluable tumor assessment prior to resection. For participants who had BOR of SD at Week 12, the date of PD following thereafter (where available) was used in the analysis of duration of stable disease. For participants with BOR of SD who had not subsequently progressed and who remained alive, duration of stable disease was censored on the date of last evaluable tumor assessment. Median and associated 2-sided 95% confidence intervals were calculated using the Brookmeyer and Crowley method.|From date of randomization until 540 death events occurred (approximately 48 months)|All randomized participants||months||95% Confidence Interval|Median
857311|NCT01515189|Secondary|Duration of Response by mWHO Criteria|Duration of response for participants whose BOR was CR or PR was defined as the time between the date measurement criteria were first met for overall response of PR or CR (whichever status was recorded first) and the date of disease progression or death (whichever occurred first). For participants who underwent tumor resection following response but prior to disease progression, duration of response was censored on the date of last evaluable tumor assessment prior to resection. For participants who had BOR of SD, PR or CR at Week 12, or a confirmed response of PR or CR before Week 12, the date of PD following thereafter (where available) was used in the analysis of duration of response. For those participants who remained alive and had not progressed following response, duration of response was censored on the date of last evaluable tumor assessment. Median and associated 2-sided 95% confidence intervals were calculated using the Brookmeyer and Crowley method.|From date of randomization until 540 death events occurred (approximately 48 months)|All randomized participants||months||95% Confidence Interval|Median
857312|NCT01515189|Secondary|Disease Control Rate (DCR) by mWHO Criteria|DCR by treatment arm was defined as the total number of randomized participants in the arm whose BOR is CR, PR or SD, divided by the total number of randomized participants in the arm. Any participant who was unevaluable for Disease Control (DC), (e.g. on account of missing or “not evaluable” assessments), was included in the denominator of the calculation (i.e. was considered a non-responder with respect to the DCR endpoint). 95% 2-sided exact confidence intervals were computed using the Clopper and Pearson method.|From date of randomization until 540 death events occurred (approximately 48 months)|All randomized participants||percentage of participants with DC||95% Confidence Interval|Number
857313|NCT01515189|Secondary|Best Overall Response Rate (BORR) by mWHO Criteria|BORR by treatment arm was defined as the total number of randomized participants in the arm whose BOR is CR or PR, divided by the total number of randomized participants in the arm. Any participant who was unevaluable for BOR, e.g. on account of missing or “not evaluable” assessments, was included in the denominator of the calculation (i.e. was considered a non-responder with respect to the BORR endpoint). 95% 2-sided exact confidence intervals were computed using the method of Clopper and Pearson.|From date of randomization until 540 death events occurred (approximately 48 months)|All randomized participants||percentage of participants with BORR||95% Confidence Interval|Number
857314|NCT01515189|Secondary|Progression Free Survival (PFS) by mWHO Criteria|PFS was defined as the time between randomization date and the date of progression or death, whichever occurred first. A participant who died without reported prior progression was considered to have progressed on the date of death. For a participant who underwent resection post randomization, PFS was censored on last tumor assessment date prior to resection. For those who remained alive and had not progressed, PFS was censored on last evaluable tumor assessment date. Participants who had not died and had no recorded post-baseline tumor assessment were censored at the day of randomization. For participants who had Progressive Disease (PD) prior to Week 12 and a subsequent assessment of Stable Disease (SD), Partial Response (PR), or Complete Response (CR), the date of PD following response was used in the analysis of PFS; otherwise these participants were censored on the date of their last tumor assessment. Median and 2-sided 95% CIs were calculated with Brookmeyer Crowley method.|From date of randomization until 540 death events occurred (approximately 48 months)|All randomized participants.||months||95% Confidence Interval|Median
857315|NCT01515189|Primary|Overall Survival (OS)|OS is defined for each participant as the time between randomization date and death due to any cause. The survival time for participants who had not died was censored at the last known alive date. Median and associated 2-sided 95% confidence intervals were calculated using the method of Brookmeyer and Crowley.|From date of randomization until 540 death events occurred (approximately 48 months)|All randomized participants||months||95% Confidence Interval|Median
857316|NCT01495988|Secondary|Correlate Blood Markers of B-RAFV600 Mutation With Treatment Efficacy|Assess the effectiveness of blood reverse transcription polymerase chain reaction (RT-PCR) assay for BRAFV600 as a surrogate biomarker for tumor response and resistance in patients receiving vemurafenib/cobimetinib +/- bevacizumab.|Upon completion of the protocol (3 years)|The trial was terminated prematurely during the phase Ib safety lead-in and outcome measures were not analyzed due to significantly underpowered data and the MTD being undetermined.|||||
857317|NCT01495988|Secondary|Effects of the Addition of Bevacizumab on Tumor Angiogenesis, Resistance Mechanisms and Immune Function|Perform a variety of correlative studies aimed at understanding the effects of vemurafenib/cobimetinib, and bevacizumab administration relative to vemurafenib/cobimetinib on tumor angiogenesis, resistance mechanisms and immune function.|Upon completion of the protocol (3 years)|The trial was terminated prematurely and outcome measures were not analyzed.|||||
857318|NCT01495988|Secondary|Toxicity and Safety Profile|Describe the toxicity and safety profile of treatment with vemurafenib/cobimetinib versus vemurafenib/cobimetinib and bevacizumab in patients with stage IV, BRAFV600E/K melanoma.|Until study completion|The trial was terminated prematurely during the phase Ib safety lead-in and outcome measures were not analyzed due to significantly underpowered data and the MTD being undetermined.|||||
857319|NCT01495988|Secondary|Response Rates|Compare response rate (RR) of patients with stage IV, BRAFV600E/K melanoma treated with vemurafenib/cobimetinib versus vemurafenib/cobimetinib and bevacizumab.|From time of randomization to time of disease progression (restaging for tumor response to occur every 8 wks until wk 48, then every 12 wks thereafter)|The trial was terminated prematurely during the phase Ib safety lead-in and outcome measures were not analyzed due to significantly underpowered data and the MTD being undetermined.|||||
857321|NCT01495988|Primary|Median Progression-free Survival|To compare median progression-free survival (PFS) of patients with stage IV, BRAFV600E or BRAFV600K melanoma treated with vemurafenib/cobimetinib versus vemurafenib/cobimetinib and bevacizumab.|Time between randomization and disease progression (~10-15 months)|The trial was terminated prematurely during the phase Ib safety lead-in and outcome measures were not analyzed due to significantly underpowered data and the MTD being undetermined.|||||
857322|NCT01495988|Primary|Maximum Tolerated Dose|To establish the maximum tolerated dose (MTD) of bevacizumab in combination with vemurafenib and cobimetinib.|Until MTD determined (up to 6 months)|The trial was terminated prematurely during the phase Ib safety lead-in and outcome measures were not analyzed. MTD could not be determined.|||||
857323|NCT01455519|Secondary|Change in NRS After Box Lift|Numeric Rating Scale (NRS) pain score was given verbally after completing functional box lift test on a scale 0-10 (0=none, and 10=the worst).|Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention|||NRS pain score||Standard Error|Mean
857324|NCT01455519|Secondary|Change in NRS After Sit to Stand Repetitions|Numeric Rating Scale (NRS) pain score was given verbally after completing functional sit to stand test on a scale 0-10 (0=none, and 10=the worst).|Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention|||NRS pain score||Standard Error|Mean
857325|NCT01455519|Secondary|Change in NRS After Treadmill Walk|Numeric Rating Scale (NRS) pain score was given verbally after completing functional treadmill walk test on a scale 0-10 (0=none, and 10=the worst).|Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention|||NRS pain score||Standard Error|Mean
857326|NCT01455519|Secondary|Change in NRS After Stair Climb|Numeric Rating Scale (NRS) pain score was given verbally after completing functional stair climb test on a scale 0-10 (0=none, and 10=the worst).|Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention|||NRS pain score||Standard Error|Mean
857327|NCT01455519|Secondary|Change in Time to Lift Box|Time to lift 13 pound box to floor and back up to table.|Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention|||seconds per lift||Standard Error|Mean
857328|NCT01455519|Secondary|Change in Distance to Floor|Distance from fingers to Floor when bending forward. A functional test of flexibility|Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention|||centimeters||Standard Error|Mean
857329|NCT01455519|Secondary|Change in Sit to Stand Repetitions|Sit to stand repetitions completed in 1 minute|Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention|||number of repetitions||Standard Error|Mean
857330|NCT01455519|Secondary|Change in Treadmill Distance Walked|Treadmill distance walked in 6 minutes|Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention|||miles||Standard Error|Mean
857331|NCT01455519|Secondary|Change in Stair Climb Time|Time to climb 1 flight of stairs|Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention|||seconds||Standard Error|Mean
857332|NCT01455519|Secondary|Change in Pain Disability|The Pain Disability Index (PDI) is a seven-item, validated instrument that assesses perceived disability in seven key life areas. It provides a total disability score, and is an indirect measure of self efficacy. The Pain Disability Scale is a scale from 0 - 70, where 0 = no Disability and 70 = the most Disability.|Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention|||units on a scale||Standard Error|Mean
857333|NCT01455519|Secondary|Change in PASS|Anxiety scores were collected at least two data points. The Pain Anxiety Symptoms Scale (PASS) is a scale from 0 - 100, where 0 = no anxiety and 100 = the most anxiety.|Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention|||units on a scale||Standard Error|Mean
857334|NCT01455519|Primary|Change in VAS|Visual Analogue Scale is a self report pain scale on a scale 0(no pain) to 100 (the worst pain imaginable).|Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention|||units on a scale||Standard Error|Mean
857335|NCT01455519|Primary|Change in McGill Pain Questionnaire – Short Form|The McGill Pain Questionnaire – Short Form (MPQ-SF) is a well-validated pain measure that permits separation of the sensory and affective components of pain, which are added together to compute a total score. The scale ranges from 0-45 (0=no pain, 45=the most pain).|Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention|||units on a scale||Standard Error|Mean
857336|NCT01452529|Secondary|Responder Analysis for Subjects With a ≥ 50% Reduction in Pain Compared to Baseline|A subject’s response to treatment was defined as the percentage reduction from the screening mean pain score to the mean pain intensity at week 12 of the double-blind period.|Week 12||||||
857337|NCT01452529|Secondary|Responder Analysis for Subjects With a ≥ 30% Reduction in Pain Compared to Baseline|A subject’s response to treatment was defined as the percentage reduction from the screening mean pain score to the mean pain intensity at week 12 of the double-blind period.|Week 12||||||
857338|NCT01452529|Secondary|Patient Global Impression of Change (PGIC)|"The PGIC observational scale was completed by the subject. Subjects were asked to assess the change in overall status relative to the start of the study. The scale has only 1 item, which measures global change of overall status by the subject on a 7-point scale (Very much improved, Much improved, Minimally improved, No change, Minimally worse, Much worse, Very much worse), where 1 = very much improved and 7 = very much worse. The proportion of subjects responding much improved and very much improved was summarized by treatment group and compared between groups using an exact test."|Week 12||||||
857339|NCT01452529|Secondary|Medical Outcome Study Sleep Scale - Revised (MOS Sleep-R)|The scale consists of 12 individual items categorized into a sleep problems index and 6 subscales: 4 sleep disturbance, 2 sleep adequacy, 1 quantity of sleep, 3 daytime somnolence, 1 snoring, 1 shortness of breath. Scores range from 0 to 100, where higher scores indicate greater sleep disturbance.|Weeks 4, 8, and 12||||||
858146|NCT01665599|Secondary|Pharmacokinetics of Total Testosterone Measuring Minimum Concentration Observed (Cmin)|A validated LC/MS/MS method was used to determine the levels of total testosterone.|Day 1; Day 90|ITT population was used which comprised of all participants who received at least one dose of IMP.||ng/dL||Standard Deviation|Mean
858408|NCT01245062|Secondary|Overall Survival in All Participants|Overall survival was defined as the time from the date of randomization to the date of death due to any cause.|Day 1 until death due to any cause (average of 4.8 months)|ITT Population||Months||95% Confidence Interval|Median
857357|NCT01400139|Secondary|Treatment Satisfaction Questionnaire (TSQ) - Part II|The TSQ is a self-administered questionnaire that consists of 2 parts. Part II has 2 questions that measure the subject's willingness to continue the use of study drug as pain medication (Q1), and to recommend the study drug to someone else (Q2). Question 1 consists of 6 categories of response rated on a scale from 1 (very willing to continue) to 6 (very unwilling to continue): 1=Very willing to continue; 2=Willing to continue; 3=Somewhat willing to continue; 4=Somewhat unwilling to continue; 5=Unwilling to continue; 6=Very unwilling to continue. Question 2 consists of 3 categories of response: 1=yes; 2=no; 3=undecided.|At Week 52 or upon early discontinuation at or before Week 4 in maintenance and at Week 24 in extension||||||
857358|NCT01400139|Secondary|Treatment Satisfaction Questionnaire (TSQ) - Part I|The TSQ is a self-administered questionnaire that consists of 2 parts. Part I has 6 questions (Q1 to Q6) that ask the subject to rate the experience with use of the study drug in comparison to the prestudy pain medication regarding ease of use, convenience, frequency, pain control, and overall satisfaction. Each question was rated on a scale from 1 (extremely satisfied) to 6 (extremely dissatisfied): Q1=Satisfaction with study drug; Q2=Ease of study drug use to treat pain; Q3=Convenience of study drug to treat pain; Q4=Overall drug satisfaction managing pain; Q5=Satisfaction with frequency of use; Q6=Ease of planning study drug use. TSQ - Part I was not administered in the extension period.|At Week 52 or upon early discontinuation at or before Week 4 in maintenance||||||
857359|NCT01400139|Secondary|Patient Global Impression of Change (PGIC)|The PGIC is an ordinal scale of global evaluation that assesses the change in overall status relative to the start of the study. The scale has only 1 item that measures global change of overall status (improvement or worsening) by the subject on a 7-point scale (Very much improved, Much improved, Minimally improved, No change, Minimally worse, Much worse, Very much worse. The proportion of subjects with a response of “much improved” (category 2) and “very much improved” (category 1), is provided along with 95% confidence intervals for the proportion.|At Week 52 in maintenance and at Week 24 in extension||||||
857360|NCT01400139|Secondary|Medical Outcomes Study 36-item Short Form (SF-36)|The SF-36 is a generic health survey with 36 items that measure functional health and well-being from the subject’s perspective. The 36 questions are grouped into 11 sections. Some of the sections consist of multiple questions. The survey is summarized into 8 dimensions/scales: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. From the 8 health dimensions, physical component summary, and mental component summary measures are derived. For SF-36, a higher score indicates a better perception of health.|Up to 52 weeks in maintenance and up to 24 weeks in extension||||||
857361|NCT01400139|Secondary|Brief Pain Inventory Short Form (BPI-SF) - Pain Interference|The BPI-SF questionnaire was used to assess the severity of pain and the interference of pain on daily functions. It consists of 9 sections that measure pain location, intensity, pain treatment, and functional interference of pain on mood and every day activities. Four of the items (questions 3 through 6) assess the severity of pain and 7 items (questions 9A through 9G) assess the interference of pain. The pain severity subscale was determined by calculating the arithmetic mean of the responses to items 3, 4, 5 and 6. For BPI, a lower score indicates a lower pain.|Up to 52 weeks in maintenance and up to 24 weeks in extension||||||
857362|NCT01400139|Secondary|Medical Outcomes Study (MOS) Sleep Scale - Revised (MOS Sleep-R)|The MOS Sleep-R is a brief, self-administered 12-item assessment designed to measure key aspects of sleep: sleep problems index II and 6 subscale scores – sleep disturbance, sleep adequacy, daytime somnolence, snoring, awaken short of breath or with headache, and quantity of sleep. For the derived scores in the MOS Sleep-R, a higher score indicates a better sleep pattern.|Up to 52 weeks in the Core Study maintenance period, and up to 24 weeks in the Extension Period||||||
857363|NCT01400139|Secondary|"Pain Right Now Score"|"“Pain right now” scores were collected using an 11-point scale where 0 = no pain and 10 = pain as bad as you can imagine. The pain right now scores were only collected during the Core Study. “Pain right now” scores were not assessed during the Extension Period."|Week 12||||||
857364|NCT01400139|Primary|"Daily Average Pain Over the Last 24 Hours"|"Average pain over the last 24 hours score (on an 11-point numerical rating scale where 0 = no pain and 10 = pain as bad as you can imagine)."|Core study: from start to end of maintenance period (up to 52 weeks); Extension study: from start of maintenance to end of extension (up to 76 weeks)|The Core Study population analyzed (N=727) was the group of subjects who received at least 1 dose of study drug during the maintenance period. The Extension Period population analyzed (N=106) was the group of core study safety population subjects who entered the extension period and received at least 1 dose of study drug in the extension period.||units on a scale||Standard Deviation|Mean
857365|NCT01400139|Primary|The Number of Participants With Adverse Events as a Measure of Safety|Safety assessments included AEs, clinical laboratory test results, vital sign measurements, ECG findings, and audiology assessments.|Up to 84 weeks|The Core Study safety population (N=922) was defined as the group of subjects who received at least 1 dose of study drug during the study. The Extension Period safety population (N=106) was the group of core study safety population subjects who entered the extension period and received at least 1 dose of study drug in the extension period.||participants|||Number
857392|NCT01288534|Secondary|Frequency of Required Interventions.|To assess the frequency of required interventions (interruptions) based on real-time prostate translations and rotations to verify that the proposed planning target volume(PTV) margins and action level are appropriate and practical. This will be assessed by the percentage of patients with no interventions for any fraction, the percentage of patients with 1-2 fractions interrupted and the percentage of patients with more than two fractions interrupted and the percentage of patients that had an interruption of the beam at least once for all 5 fractions.|5 years|||percentage of participants|||Number
857393|NCT01288534|Secondary|Relation Between Reconstructed Delivered Dose Distributions.|To determine the relation between reconstructed delivered dose distributions, accounting for prostate translation and rotation, and tumor control probabilities.|5 years|Data was not collected in full by some centers for their patients and these endpoints couldn't be analyzed|||||
857394|NCT01288534|Secondary|Relation Between Dose Distribution and Toxicities.|To look at the relation between dose distribution and toxicities and to determine if reconstructed delivered doses are more predictive of toxicity than planned doses.|5 years|Data was not collected in full by some centers for their patients and these endpoints couldn't be analyzed.|||||
857395|NCT01288534|Secondary|Percentage of Patients With a PSA Nadir of <3.35 ng/ml at 12 Months|To estimate one year prostate specific antigen (PSA)control of prostate cancer when treated with stereotactic body radiotherapy (SBRT) using continuous real-time evaluation of prostate motion.|1 Year|||percentage of patients|||Number
857396|NCT01288534|Primary|Percentage of Patients With a Minimally Detected Decline (MDD) in Quality of Life (QOL)|"To evaluate the safety of the proposed hyperfractionation regimen of 5 fractions of radiation to treat prostate cancer with guidance of radiation using the Calypso 4D Treatment System (Calypso, and to compare it to that expected from conventional treatment, which would involve 40-42 smaller radiation fractions over 8-9 weeks.
Percentage of patients with a MDD in Quality of Life (QOL) surveys for urinary incontinence (UI), urinary obstructive (UO), bowel (BS), and sexual (SS) domains were reviewed at 6 months and 24 months."|24 months|||percentage of patients|||Number
857467|NCT01147653|Post-Hoc|Change in Whole Brain Connectivity Measured by Diffusion Tensor Magnetic Resonance Imaging (MRI) of All Subjects 1 Year Post-infusion With Autologous UCB|Change in whole brain connectivity measured by diffusion tensor magnetic resonance imaging (MRI). Changes in connectivity are normalized to white matter volume.|1 year post-infusion with autologous umbilical cord blood|This group combines patients who received Autologous Umbilical Cord Blood whether at baseline or 1 year post-infusion with Placebo and is limited to patients without morphologic brain abnormalities that prevented accurate anatomical image parcellation. Low/High dose is defined as the median dose infused in all 63 enrolled patients, 2x10e7 TNCC/kg.||Number of connections x10e5||Standard Deviation|Mean
857454|NCT01223352|Other Pre-specified|Number of Patients With Treatment-emergent Hemoglobin Abnormalities|"Number of patients with marked hemoglobin decreases (absolute values below 10 g/dL). The worst post-baseline value was considered.
The treatment-emergent period was defined as study treatment start date up to 7 calendar days after study treatment end date."|24 Weeks on average|All randomized patients who received at least one dose of study drug and with available data.||Participants|||Number
857455|NCT01223352|Other Pre-specified|Number of Patients With Treatment-emergent Liver Function Abnormalities|Number of patients with increase in alanine aminotransferase (ALT) and / or aspartate aminotransferase (AST) above 3 times upper limit of normal (ULN). The worst post-baseline value was considered. The treatment-emergent period was defined as study treatment start date up to 7 calendar days after study treatment end date.|24 Weeks on average|All randomized patients who received at least one dose of study drug and with available data.||Participants|||Number
857456|NCT01223352|Other Pre-specified|Change From Baseline in Global Clincial Impression Scale (GCIS) at End of Study|The GCIS is an assessment tool providing a single global assessment of the patient’s current overall clinical condition: Very Good, Good, Neither Good or Bad, Bad and Very Bad. The assessment was performed both by the physician and the parents / legal representatives independently. Global clinical impression (GCI) at end of study was compared to GCI at baseline and the number of patients with clinical condition considered as worsened, improved or unchanged are determined.|Baseline, up to Week 24 on average|All-randomized set. Because all 64 randomized patients were treated with at least one dose of study drug, the All-randomized set was identical to the All-treated set.||Participants|||Number
857457|NCT01223352|Other Pre-specified|Change From Baseline in WHO Functional Class at End of Study|"The World Health Organization (WHO) defines 4 classes to classify the functional status of patients with pulmonary hypertension (PH):
Class I (FC I): No limitation of physical activity. Class II (FC II): Slight limitation of physical activity. Class IIII (FC III): Marked limitation of physical activity. Class IV (FC IV): Inability to carry out any physical activity without symptoms.
Number of patients with improvement (shift from a higher to a lower class), worsening (shift from a lower to a higher class) or no change in WHO functional class at end of study compared to baseline are determined."|Baseline, up to Week 24 on average|All-randomized set. Because all 64 randomized patients were treated with at least one dose of study drug, the All-randomized set was identical to the All-treated set.||Participants|||Number
857507|NCT01012492|Secondary|The Rate of Grades III-IV Acute GVHD at 2 Years.|The rates of Grades III-IV acute GVHD were measured at 2 years according to standard Glucksberg criteria, which was 10%.|2 years after transplant|||percentage of participants|||Number
857458|NCT01223352|Other Pre-specified|Dose-corrected Daily Exposure [AUC(0-24c)] to Bosentan Metabolites (Ro 478634, Ro 485033, Ro 641056)|Concentrations of the metabolites were measured directly in blood samples collected prior to study drug administration and up to 8 hours or up to 12 hours post-dose for the t.i.d and b.i.d. dosing regimen, respectively. Daily exposure to the metabolites corresponds to the area under the concentration-time curve [AUC(0-24)] of the corresponding metabolite over a period of 24 hours, and was calculated in the same manner as the primary endpoint. AUC(0-24c) was corrected to 2 mg/kg (target dose) [AUC(0-24c)].|0, 0.5, 1, 3, 5 (or 7.5), 8 (or 12 hours) post-dose at Week 4, after at least 2 weeks of stable study drug treatment|Per protocol PK analysis set (PK set): All patients included in the bosentan 2 mg/kg b.i.d. and bosentan 2 mg/kg t.i.d. groups who received at least one dose of bosentan and who were able to provide at least 5 blood samples for PK assessments and who did not violate the protocol in a way that might affect the evaluation of the PK main endpoint.||h*ng/mL||95% Confidence Interval|Geometric Mean
857459|NCT01223352|Other Pre-specified|Time to Reach Cmax [Tmax] of Bosentan|"Concentrations of bosentan were measured directly in blood samples collected prior to study drug administration and up to 8 hours or up to 12 hours post-dose for the t.i.d and b.i.d. dosing regimen, respectively.
tmax was obtained directly from the measured plasma concentrations."|0, 0.5, 1, 3, 5 (or 7.5), 8 (or 12 hours) post-dose at Week 4, after at least 2 weeks of stable study drug treatment|Per protocol PK analysis set (PK set): All patients included in the bosentan 2 mg/kg b.i.d. and bosentan 2 mg/kg t.i.d. groups who received at least one dose of bosentan and who were able to provide at least 5 blood samples for PK assessments and who did not violate the protocol in a way that might affect the evaluation of the PK main endpoint.||hours||Full Range|Median
857460|NCT01223352|Other Pre-specified|Dose-corrected Maximum Plasma Concentration [Cmaxc] of Bosentan|"Concentrations of bosentan were measured directly in blood samples collected prior to study drug administration and up to 8 hours or up to 12 hours post-dose for the t.i.d and b.i.d. dosing regimen, respectively.
The peak plasma concentration (Cmax) of bosentan was directly obtained from the measured plasma concentrations and was dose-corrected to the target dose of 2 mg/kg (Cmaxc)."|0, 0.5, 1, 3, 5 (or 7.5), 8 (or 12 hours) post-dose at Week 4, after at least 2 weeks of stable study drug treatment|Per-protocol PK analysis set (PK set): All patients included in the bosentan 2 mg/kg b.i.d. and bosentan 2 mg/kg t.i.d. groups who received at least one dose of bosentan and who were able to provide at least 5 blood samples for PK assessments and who did not violate the protocol in a way that might affect the evaluation of the PK main endpoint.||ng/mL||95% Confidence Interval|Geometric Mean
857461|NCT01223352|Primary|Dose-corrected Daily Exposure [AUC(0-24c)] to Bosentan|"Daily exposure was measured by the area under the plasma concentration-time curve over a period of 24 hours [AUC(0-24)].
Concentrations of bosentan were measured directly in blood samples collected prior to study drug administration and up to 8 hours or up to 12 hours post-dose for the t.i.d and b.i.d. dosing regimen, respectively. AUC(0-24) was calculated as a multiple of AUCtau, which is the AUC over a dosing interval (AUCtau x 2 for the b.i.d. dosing regimen and AUCtau x 3 for the t.i.d. regimen). As the smallest dose unit was 8 mg (1/4 tablet), it was not possible to achieve the exact target dose of 2 mg/kg. Therefore, AUC(0-24) was corrected to 2 mg/kg (target dose) [AUC(0-24c)]."|0, 0.5, 1, 3, 5 (or 7.5), 8 (or 12 hours) post-dose at Week 4, after at least 2 weeks of stable study drug treatment|Per-protocol PK analysis set (PK set): All patients included in the bosentan 2 mg/kg b.i.d. and bosentan 2 mg/kg t.i.d. groups who received at least one dose of bosentan and who were able to provide at least 5 blood samples for PK assessments and who did not violate the protocol in a way that might affect the evaluation of the PK main endpoint.||h*ng/mL||95% Confidence Interval|Geometric Mean
857508|NCT01012492|Primary|Percentage of Participants With Grade III-IV Acute GVHD by Day 100.|Grade III-IV Acute GVHD by Day 100. The incidence of Gr III-IV acute GVHD was measured by the modified Glucksburg scale.|Day 100 post-transplant|||percentage of participants|||Number
857468|NCT01147653|Post-Hoc|Peabody Gross Motor Quotient Change Score 1 Year After Receiving Autologous UCB.|The Peabody Developmental Motor Scales - Second Edition (PDMS-2), Gross Motor Quotient change score was calculated for each patient at 1 year after infusion with autologous umbilical cord blood. Analyzed by infused dose, above or below the median. The Gross Motor Quotient score from the PDMS-2 was used in this study to evaluate gross motor function. The Gross Motor Quotient measures the ability to use large muscle systems for locomotion, maintain a stable posture when not moving, and throw/catch objects. The range of possible scores is 41 to 164. High scores indicate better gross motor function. Lower scores indicate less gross motor function ability.|1 year post-infusion with autologous umbilical cord blood|This group combines patients who received Autologous Umbilical Cord Blood at baseline or 1 year post-infusion with Placebo, and who are within the age range specified for the PDMS-2. The threshold defining Low/High dose is the median dose infused in all 63 enrolled patients, 2x10e7 TNCC/kg.||units on a scale||Full Range|Median
857469|NCT01147653|Post-Hoc|Observed Minus Expected GMFM-66 Change Score of All Subjects Receiving Autologous UCB and Who Are Greater Than or Equal to 2 Years of Age|Validated functional curves were used to identify the expected 1-year change in GMFM-66 score given each child's age and Gross Motor Function Classification System (GMFCS) Level at baseline. The difference between observed change (in this study) and expected change was then calculated for each participant. The threshold defining Low/High dose is the median dose infused in all 63 enrolled patients, 2x10e7 TNCC/kg.|1 year post-infusion with autologous umbilical cord blood|Patients who received cord blood at baseline and 1 year post-infusion with Placebo, and who are >=2 years old (to allow calculation of expected GMFM-66 change scores from published data). An additional 6 are excluded because change scores were not observable due to subject withdrawal (5) or inability to comply due to a broken leg (1).||units on a scale||Full Range|Median
857470|NCT01147653|Post-Hoc|Gross Motor Function Measure 66 (GMFM-66) Change Score at 1 Year by Infused Dose|Gross Motor Function Measure 66 (GMFM-66) Change Score at 1 Year. Analyzed by infused dose, above or below the median. The GMFM-66 is a clinical tool used to evaluate gross motor function in children with cerebral palsy and is scored using a propriety software program called the Gross Motor Ability Estimator (GMAE) that produces an interval level continuous score ranging from 0 to 100. Higher scores indicate better motor function. A negative change in GMFM-66 score indicates a reduction in motor function, a positive change indicates improvement in motor function, and zero indicates no change in motor function.|1 Year|Patients randomized to Autologous Umbilical Cord Blood were divided into two groups for this analysis: Low and High dose. The median dose infused in these 32 patients was used as the cut point to define Low and High doses: 1.98x10e7 total nucleated cells per kilogram of patient weight (TNCC/kg).||units on a scale||Full Range|Median
857471|NCT01147653|Other Pre-specified|Change in Barry-Albright Dystonia Total Score From Baseline to Year 1|The Barry-Albright Dystonia Scale measures generalized dystonia in eight body regions (eyes, mouth, neck, trunk, and the four extremities) using an ordinal scale (0=no dystonia, 1=slight dystonia, 2=mild dystonia, 3=moderate dystonia, and 4=severe dystonia). Individual scores for each region are summed to obtain a total score. The total score can range from 0 to 32 and higher scores indicate an overall greater degree of dystonia. The change in Barry-Albright Dystonia Total Score was evaluated from Baseline to Year 1. Positive numbers indicate increasing dystonia, negative numbers indicate a decrease in dystonia, and zero indicates no change.|Baseline to Year 1|||units on a scale||Full Range|Median
857472|NCT01147653|Secondary|Parent Experience of Child Illness|This outcome measure was not used in this study because it had not been validated for children with Cerebral Palsy.|Baseline to Year 1||||||
857473|NCT01147653|Secondary|Change in Bruininks-Oseretsky-2 Total Motor Composite From Baseline to Year 1|The Bruininks-Oseretsky Test of Motor Proficiency, Second Edition, (BOT-2) evaluates motor function in four areas: stability, mobility, strength, coordination, and object manipulation. A Total Motor Composite is then calculated and expressed on a normal distribution with mean 50 and standard deviation of 10. Higher scores indicate better motor function. The BOT-2 Total Motor Composite was used to measure motor function in children at age 6 in this study. The study intended to evaluate change in the BOT-2 Total Motor Composite from Baseline to Year 1, where positive change indicates improvement in motor function, negative change indicates decrease in motor function, and zero indicates no change.|Baseline to Year 1|The BOT-2 Total Motor Composite was available at Baseline and Year 1 in only 1 subject. The change score for that subject is reported here.||units on a scale|||Number
857474|NCT01147653|Secondary|Modified Ashworth Scale at Year 1|The Modified Ashworth Scale uses a 6 point scale (range 0, 1, 1+, 2, 3, or 4) to measure spasticity in 5 body regions (central, right upper extremity, left upper extremity, right lower extremity, and left lower extremity). Scores of 0 indicate no increase in muscle tone whereas a score of 4 indicates rigidity in flexion or extension.|Year 1|Patients are classified by their maximum score, regardless of body region.||Participants|||Count of Participants
857475|NCT01147653|Secondary|Modified Ashworth Scale at Baseline|The Modified Ashworth Scale uses a 6 point scale (range 0, 1, 1+, 2, 3, or 4) to measure spasticity in 5 body regions (central, right upper extremity, left upper extremity, right lower extremity, and left lower extremity). Scores of 0 indicate no increase in muscle tone whereas a score of 4 indicates rigidity in flexion or extension.|Baseline|Patients are classified by their maximum score, regardless of body region.||Participants|||Count of Participants
857476|NCT01147653|Secondary|Change in Difficult Child Score From Baseline to Year 1|Parent stress was evaluated with the Parenting Stress Index - Short Form for children aged 0-12 years, which measures stress in three domains: Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child. Results in each domain are expressed as percentiles. Scores from the 15th-80th percentile are considered to be within the normal range. Scores at or above the 85th percentile considered high distress. Scores greater than the 89th percentile indicate clinically significant levels of distress. Analysis focused on changes in percentile scores between Baseline and Year 1. Positive numbers represent an increase in distress, negative numbers represent a decrease in distress, and zero indicates no change.|Baseline to Year 1|No participants were outside the age range for this test but change scores could not be calculated for some participants due either to missing data at the Baseline or Year 1 visit.||units on a scale||Standard Error|Mean
857477|NCT01147653|Secondary|Change in Parent-Child Dysfunctional Interaction From Baseline to Year 1|Parent stress was evaluated with the Parenting Stress Index - Short Form for children aged 0-12 years, which measures stress in three domains: Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child. Results in each domain are expressed as percentiles. Scores from the 15th-80th percentile are considered to be within the normal range. Scores at or above the 85th percentile considered high distress. Scores greater than the 89th percentile indicate clinically significant levels of distress. Analysis focused on changes in percentile scores between Baseline and Year 1. Positive numbers represent an increase in distress, negative numbers represent a decrease in distress, and zero indicates no change.|Baseline to Year 1|No participants were outside the age range for this test but change scores could not be calculated for some participants due either to missing data at the Baseline or Year 1 visit.||units on a scale||Full Range|Median
857478|NCT01147653|Secondary|Change in Parental Distress From Baseline to Year 1|"Parent stress was evaluated with the Parenting Stress Index – Short Form for children aged 0-12 years, which measures stress in three domains: Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child. Results in each domain are expressed as percentiles. Scores from the 15th-80th percentile are considered to be within the normal range.
Scores at or above the 85th percentile considered high distress. Scores greater than the 89th percentile indicate clinically significant levels of distress. Analysis focused on changes in percentile scores between Baseline and Year 1. Positive numbers represent an increase in distress, negative numbers represent a decrease in distress, and zero indicates no change."|Baseline to Year 1|No participants were outside the age range for this test but change scores could not be calculated for some participants due either to missing data at the Baseline or Year 1 visit.||Change in percentile score||Standard Error|Mean
857479|NCT01147653|Secondary|Change in Child Behavior Checklist (CBCL) Z-score Total Problems From Baseline to Year 1|Two versions of the CBCL exist for children ages 1.5 to 5 years and ages 6-18 years. The CBCL evaluates internalizing and externalizing behaviors and total problems using 99-item assessments that are scored on an ordinal scale as 0 for “not true of the child,” 1 for “somewhat or sometimes true of the child,” and 2 for “very true or often true of the child” based on behavior in the preceding two months. Scores are expressed on a standard normal distribution with mean 50 and standard deviation 10. Z scores were created for analysis. A Z-score represents the distance from the population mean in terms of the number of standard deviations. The change in Z-score from Baseline to Year 1 was calculated for each patient. A positive number indicates an increase in the behavior, a negative number indicates a decrease in the behavior, and a zero indicates no change.|Baseline to Year 1|Evaluations done outside the age ranges specified for the assessments were excluded, the majority being assessments that were done on patients who were not yet 1.5 years of age.||units on a scale||Full Range|Median
857480|NCT01147653|Secondary|Change in Child Behavior Checklist (CBCL) Z-score Externalizing Problems From Baseline to Year 1|Two versions of the CBCL exist for children ages 1.5 to 5 years and ages 6-18 years. The CBCL evaluates internalizing and externalizing behaviors and total problems using 99-item assessments that are scored on an ordinal scale as 0 for “not true of the child,” 1 for “somewhat or sometimes true of the child,” and 2 for “very true or often true of the child” based on behavior in the preceding two months. Scores are expressed on a standard normal distribution with mean 50 and standard deviation 10. Z scores were created for analysis. A Z-score represents the distance from the population mean in terms of the number of standard deviations. The change in Z-score from Baseline to Year 1 was calculated for each patient. A positive number indicates an increase in the behavior, a negative number indicates a decrease in the behavior, and a zero indicates no change.|Baseline to Year 1|Evaluations done outside the age ranges specified for the assessments were excluded, the majority being assessments that were done on patients who were not yet 1.5 years of age.||units on a scale||Standard Error|Mean
857481|NCT01147653|Secondary|Change in Child Behavior Checklist (CBCL) Z-score Internalizing Problems From Baseline to Year 1|Two versions of the CBCL exist for children ages 1.5 to 5 years and ages 6-18 years. The CBCL evaluates internalizing and externalizing behaviors and total problems using 99-item assessments that are scored on an ordinal scale as 0 for “not true of the child,” 1 for “somewhat or sometimes true of the child,” and 2 for “very true or often true of the child” based on behavior in the preceding two months. Scores are expressed on a standard normal distribution with mean 50 and standard deviation 10. Z scores were created for analysis. A Z-score represents the distance from the population mean in terms of the number of standard deviations. The change in Z-score from Baseline to Year 1 was calculated for each patient. A positive number indicates an increase in the behavior, a negative number indicates a decrease in the behavior, and a zero indicates no change.|Baseline to Year 1|Evaluations done outside the age ranges specified for the assessments were excluded, the majority being assessments that were done on patients who were not yet 1.5 years of age.||units on a scale||Full Range|Median
857482|NCT01147653|Secondary|Change in Pediatric Evaluation of Disability (PEDI) Social Function Score|The Pediatric Evaluation of Disability is used to evaluate functional skills in children aged 6 months to 7 years in three areas: Self Care, Mobility, and Social Function. The score in each area can range from 10-90. Higher scores indicate higher function. The change from Baseline to Year 1 in the Social Function score is presented here. Positive scores indicate increased function, negative scores indicate a decrease, and zero indicates no change.|Baseline to Year 1|Patients were excluded if change scores were not observable due to missing data at Baseline or Year 1.||units on a scale||Standard Error|Mean
857483|NCT01147653|Secondary|Change in Pediatric Evaluation of Disability (PEDI) Mobility Score|The Pediatric Evaluation of Disability is used to evaluate functional skills in children aged 6 months to 7 years in three areas: Self Care, Mobility, and Social Function. The score in each area can range from 10-90. Higher scores indicate higher function. The change from Baseline to Year 1 in the Mobility score is presented here. Positive scores indicate increased function, negative scores indicate a decrease, and zero indicates no change.|Baseline to Year 1|Patients were excluded if change scores were not observable due to missing data at Baseline or Year 1.||units on a scale||Full Range|Median
857484|NCT01147653|Secondary|Change in Pediatric Evaluation of Disability (PEDI) Self Care Score|The Pediatric Evaluation of Disability is used to evaluate functional skills in children aged 6 months to 7 years in three areas: Self Care, Mobility, and Social Function. The score in each area can range from 10-90. Higher scores indicate higher function. The change from Baseline to Year 1 in the Self Care score is presented here. Positive scores indicate increased function, negative scores indicate a decrease, and zero indicates no change.|Baseline to Year 1|Patients were excluded if change scores were not observable due to missing data at Baseline or Year 1.||units on a scale||Standard Error|Mean
857485|NCT01147653|Secondary|Change in Assisting Hand Assessment (AHA) Score From Baseline to Year 1|The Assisting Hand Assessment (AHA) measures the use of hemiplegic cerebral palsy patients' involved hand in tasks involving two hands. The test is valid for ages 18 months to 12 years. The score is an interval scale ranging from 22 to 88 with higher numbers indicating more effective use of the affected hand in performance of bimanual tasks. Change in this score was evaluate between Baseline and Year 1. Positive numbers indicate more effective use of the affected hand, negative numbers indicate a reduction in the effective use of the affected hand, and a zero indicates no change.|Baseline to Year 1|Participants who were less than 18 months old, or had diplegia or quadriplegia were excluded. For those with unspecified typography, AHA scores were excluded if scores on either the Modified Ashworth Scale or Barry-Albright Dystonia scale indicated neither or both of the upper extremities were involved.||units on a scale||Standard Error|Mean
857486|NCT01147653|Secondary|Change in Cognitive Z-Score From Baseline to Year 1|Because patients in this study were evaluated with different cognitive assessments based on their age at the time of assessment (The Bayley-III Cognitive Composite, the WPSSI-III Full Scale IQ, and the WISC-IV Full Scale IQ Composite), with some patients being assessed using different tools at subsequent visits during the trial, a method for combining the assessments was employed to evaluate change in cognitive function over time in as many patients as possible. A cognitive Z-score was calculated for each participant at Baseline and Year 1 by adjusting each score by the relevant assessments’ population mean and standard deviation. The Z-scores represent the distance from the population mean, as measured by standard deviations. The analysis presented here summarizes the change in Z-score between Baseline and Year 1. A positive number indicates an increase in cognitive function, a negative number indicates a decrease, and zero indicates no change.|Baseline to Year 1|When using all available cognitive assessments, the change in cognitive Z-score was available for 42 of the 63 participants.||Z scores||Standard Error|Mean
857487|NCT01147653|Secondary|Change in the Wechsler Intelligence Scale for Children (WISC-IV) From Baseline to Year 1.|Cognitive function was assessed in English-speaking study participants using one of three different tools depending on the age of the patient at the time of assessment: The Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III), the Wechsler Intelligence Scale for Children (WISC-IV), and the Wechsler Preschool and Primary Scale of Intelligence (WPPSI-III). Some patients were assessed with different tools at subsequent visits as they aged during the conduct of the trial. The WISC-IV is designed for children 6 years 0 months to 16 years 11 months. This study used the Full Scale IQ, which ranges from 45 to 155 with a mean of 100 and standard deviation of 15. Higher scores indicate stronger cognitive function. Scores between 90 and 110 are considered to be within the range of average IQ.|Baseline to Year 1|Only one patient in this trial was evaluated with the WISC-IV and thus change over time could not be evaluated using this outcome measure. The single value for this patient is reported here.||Full Scale IQ Points|||Number
857488|NCT01147653|Secondary|Change in Wechsler Preschool and Primary Scale of Intelligence (WPPSI) III Full Scale Intelligence Quotient (IQ) for Younger Children (Ages 2 Years & 6 Months to 3 Years & 11 Months) From Baseline to Year 1.|Cognitive function was assessed in English-speaking study participants using one of three different tools depending on the age of the patient at the time of assessment: The Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III), the Wechsler Intelligence Scale for Children (WISC-IV), and the Wechsler Preschool and Primary Scale of Intelligence (WPPSI-III). Some patients were assessed with different tools at subsequent visits as they aged during the conduct of the trial. There are two versions of the WPPSI-III for two different age ranges: 2 years & 6 months to 3 years & 11 months, and 4 years to 7 years & 3 months. The Full Scale IQ is calculated for both age ranges and provides a continuous score with an average of 100 and a standard deviation of 15. Change from Baseline to Year 1 was evaluated, with positive numbers indicating an increase in cognitive ability, negative numbers indicating a decrease in cognitive ability, and zero indicating no change.|Baseline to Year 1|Change scores were evaluable in only 2 subjects who were assessed with the WPPSI-III at both Baseline and Year 1. One subject was randomized to Autologous Cord Blood and the other to Placebo.||units on a scale|||Number
857489|NCT01147653|Secondary|Change in Bayley Scales of Infant and Toddler Development-III, Cognitive Composite From Baseline to Year 1|Cognitive function was assessed in English-speaking study participants using one of three different tools depending on the age of the patient at the time of assessment: The Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III), the Wechsler Intelligence Scale for Children (WISC-IV), and the Wechsler Preschool and Primary Scale of Intelligence (WPPSI-III). Some patients were assessed with different tools at subsequent visits as they aged during the conduct of the trial. The Bayley-III is designed to assess developmental functioning of infants and toddlers. Scores for the Cognitive Composite range from 1 to 19 and results in the range of 8 to 12 are considered average. The outcome measure reported here is the change in Cognitive Composite between Baseline to Year 1. Positive numbers indicate increases in cognitive functioning, negative numbers indicate a decrease, and zero indicates no change.|Baseline to Year 1|The Bayley III is an age-specific test and was used for 42 patients at Baseline. A total of 27 of these patients were also scored with the Bayley III at Year 1. The results here represent change from Baseline to Year 1 in the 27 participants assessed with the Bayley III at both time points.||units on a scale||Standard Error|Mean
857490|NCT01147653|Secondary|Correlation Between Clinical Response and RNA Expression of Neural, Endothelial and Inflammatory Cytokines Measured by RNA Arrays in Cord Blood Cells Given to These Patients.|Various pre-selected neural, angiogenic, and anti-inflammatory markers expressed by UCB cells and clinical response will be evaluated.|2 years||01/2022||||
857491|NCT01147653|Secondary|Change in Loes Score of Functional MRI From Baseline to Year 1 and From Year 1 to Year 2|No data were collected from this procedure because enrolled subjects who were eligible to receive fMRI were unable to comply with the procedure.|Baseline, Year 1, Year 2|No data was available.|||||
857492|NCT01147653|Secondary|Change in Whole Brain Connectivity Measured by Diffusion Tensor Magnetic Resonance Imaging (MRI)|Change in number of connections in the brain as measured by diffusion tensor magnetic resonance imaging (MRI). Changes in connectivity are normalized to white matter volume of the brain. A positive number indicates an increase in connections, a negative number indicates a decrease, and zero indicates no change. The number of connections is expressed in terms of 10e5. For example, a change of 1 indicates an increase of 1x10e5 or 100,000 connections.|Baseline to Year 1|Patients without substantial morphologic brain abnormalities that prevented accurate anatomical image parcellation.||Number of connections x10e5||Full Range|Median
857493|NCT01147653|Secondary|Change in CP-QOL Score|Children age four years or older at study entry were assessed using the disease-specific “CP-QOL Child” assessment tool as completed by a parent. The CP-QOL Child primary-caregiver proxy form is designed for children 4 – 12 with cerebral palsy and contains 66 items which assess physical, emotional, and social well being as well as access to services and acceptance by others. Scores are summarized in seven topic areas. Scores in each area range from 0 (worst health) to 100 (best health). The change score from Baseline to Year 1 is summarized here for each item. Negative scores indicated a decrease in quality of life, positive scores indicate an increase and zero indicates no change.|Baseline, Year 1|The analysis includes patients whose parents reported scores on each item at both Baseline and Year 1 and whose children met the age criteria for the questionnaire at both time points.||units on a scale||Full Range|Median
857494|NCT01147653|Secondary|Change in IT-QOL Questionnaire Score|The Infant and Toddler Quality of Life Questionnaire (IT-QOL) was utilized for children ages one to three years at study entry.This 97-item questionnaire is completed by the parents and covers 12 concepts related to the physical, mental, and social well being of the child and the impact of their illness on the family. Scores range from 0 (worst health) to 100 (best health). The change from Baseline to Year 1 is summarized here for each of the 12 items on the questionnaire. Negative values indicate a decline in quality of life over time, positive values indicate an improvement, and zero indicates no change.|Baseline to Year 1|The analysis includes patients whose parents reported scores on each item at both Baseline and Year 1 and whose children met the age criteria for the questionnaire at both time points.||units on a scale||Full Range|Median
857495|NCT01147653|Secondary|Change in Peabody Gross Motor Quotient From Baseline to Year 1|The Peabody Developmental Motor Scales - Second Edition (PDMS-2) measures gross and fine motor skills in children from birth through five years of age. The Gross Motor Quotient score from the PDMS-2 was used in this study to evaluate gross motor function. The Gross Motor Quotient measures the ability to use large muscle systems for locomotion, maintain a stable posture when not moving, and throw/catch objects. The range of possible scores is 41 to 164. High scores indicate better gross motor function. Lower scores indicate less gross motor function ability. The change in Gross Motor Quotient from Baseline to Year 1 was evaluated in this study. Positive numbers indicate an increase in gross motor ability, negative numbers indicate decreases in gross motor function, and a zero indicates no change.|Baseline to Year 1|Participants outside of the applicable age range for the PDMS-2 at Baseline or Year 1 were excluded from the analysis.||units on a scale||Full Range|Median
857496|NCT01147653|Primary|Change in Gross Motor Function Measure 66 (GMFM-66) Score|Change in Gross Motor Function Measure 66 (GMFM-66) Score from Baseline to Year 1. The GMFM-66 is a clinical tool used to evaluate gross motor function in children with cerebral palsy and is scored using a propriety software program called the Gross Motor Ability Estimator (GMAE) that produces an interval level continuous score ranging from 0 to 100. Higher scores indicate better motor function. A negative change in GMFM-66 score indicates a reduction in motor function, a positive change indicates improvement in motor function, and zero indicates no change in motor function.|Baseline to Year 1|All enrolled patients were analyzed as randomized from Baseline to Year 1.||units on a scale||Standard Deviation|Mean
857505|NCT01012492|Secondary|Protective Immunity||3 years after transplant||||||
857506|NCT01012492|Secondary|Immunology||3 years||||||
857527|NCT00924729|Secondary|Disk Diffusion Assay of Collected Aqueous Humor|A disk diffusion assay was performed to determine the relative antimicrobial activity of the study drug in the aqueous humor. The reference organism used was a clinical isolate of S. epidermidis that will be grown and adjusted to a 0.5 MacFarland turbidity standard. The standardized suspension was inoculated onto a Mueller-Hinton II agar. A sample of the aqueous humor was applied to 6 mm sterile disks, dried, and then placed onto the inoculated Mueller-Hinton II agar plates. The plates were incubated for 24 hours at 35° C. The zone sizes were then recorded.|Approximately 3-4 months.|The amount of aqueous concentration of antibiotic agent was not enough to perform a secondary analysis|||||
857528|NCT00924729|Primary|Aqueous Humor Concentration of Study Drug|Patients were randomly assigned to receive one drop of either moxifloxacin or besifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30 minutes prior to the time of the cataract incision. The aqueous humor was corrected through the paracentesis site. The specimen was transferred immediately to a polypropylene tube and stored upright at ≤ 20° C. Moxifloxacin and besifloxacin concentrations in the aqueous humor were determined using a validated high performance liquid chromatography (HPLC)-tandem mass spectrometry method.|approximately 3 to 4 months|||µg/ml||Standard Deviation|Mean
857550|NCT00853112|Secondary|Change From Baseline in Mean Pulmonary Artery Pressure (mPAP), Systolic Pulmonary Artery Pressure (sPAP), Diastolic Pulmonary Artery Pressure (dPAP), Right Atrial Pressure (RAP) at Hour 1, 2, 3 and 4 Post Dose|Hourly changes from baseline in hemodynamic parameters were reported. Hemodynamic parameters including mPAP, sPAP, dPAP and RAP were measured using a pressure transducer positioned at the mid-axillary line with the participant in the supine position. All hemodynamic pressure measurements were performed as triplicate measurements and average was used.|Baseline, 1, 2, 3, 4 hours post-dose on Day 1|FAS included all randomized participants who received study medication. Here, 'Number Analyzed' = participants who were evaluable at given time points for each group.||millimeters of mercury (mmHg)||Standard Deviation|Mean
857543|NCT00853112|Secondary|Plasma Concentration of PF-00489791 and Sildenafil||1, 2, 3, 4, 5, 6, 8 hours post-dose on Day 1, follow up (Day 3 to 5)|Data was not reported for this outcome measure because the study was terminated and as per change in planned analysis, the pharmacokinetic parameters were not to be summarized.|||||
857544|NCT00853112|Secondary|Change From Baseline in Mean Partial Pressure of Oxygen (PaO2) and Carbon Dioxide (PaCO2) at Hour 1 and 4 Post Dose|Arterial blood samples for PaO2 and PaCO2 collected via an arterial line were assessed. PaO2 is the measure of oxygen level in the arterial blood and PaCO2 is the measure of carbon dioxide level in the arterial blood.|Baseline; 1, 4 hours post-dose on Day 1|Safety analysis set included all randomized participants who received study medication. Here, N (overall number of participants analyzed) = participants evaluable for this measure and 'Number Analyzed' = participants who were evaluable at given time points for each group.||mmHg||Standard Deviation|Mean
857545|NCT00853112|Secondary|Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Values|Criteria for clinically significant changes (changes of potential clinical concern) in ECG parameters: increase from baseline of >=30 to <60 milliseconds (msec) or >=60 msec in corrected QT interval (QTc), QT interval corrected using Fridericia’s correction (QTcF) and QT interval corrected using Bazett’s correction (QTcB); Increase from baseline of >= 25% (when baseline was >200 msec) or increase from baseline of >=50% (when baseline was <=200 msec) in PR interval; and Increase from baseline of >= 25% (when baseline was >100 msec) or increase from baseline of >=50% (when baseline was <=100 msec) in QRS interval. Number of participants with any clinically significant change in ECG values were reported.|Baseline up-to follow up (Day 3 to 5)|Safety analysis set included all randomized participants who received study medication.||Participants|||Count of Participants
857546|NCT00853112|Secondary|Number of Participants With Clinically Significant Laboratory Values|Criteria for clinically significant laboratory values:hemoglobin, hematocrit and red blood cells(less than[<]0.8*lower limit of normal[LLN]); leucocytes (<0.6*LLN/greater than[>]1.5*upper limit of normal[ULN]);platelets (<0.5*LLN></0>1.75* ULN);neutrophils, lymphocytes(<0.8*LLN></0>1.2* ULN); eosinophils, basophils, monocytes (>1.2*ULN);bilirubin (>1.5*ULN);aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase(>3*ULN);creatinine, blood urea nitrogen (>1.3*ULN);glucose(<0.6*LLN></0>1.5* ULN); uric acid(>1.2*ULN);sodium(<0.95*LLN></0>1.05*ULN); potassium, chloride, calcium(<0.9*LLN></0>1.1* ULN); albumin, total protein(<0.8></0>1.2* ULN); creatine kinase(>2.0*ULN);urine red blood cells(RBCs), urine white blood cells(WBCs)(>=6 per high-powered field);qualitative urine glucose, urine ketones, urine protein, urine blood/hemoglobin(>=1); urine bacteria(>20 per high-powered field); pregnancy test, urine protein, quantitative random serum pregnancy test (>=1).|Baseline up-to follow up (Day 3 to 5)|Safety analysis set included all randomized participants who received study medication.||Participants|||Count of Participants
857547|NCT00853112|Secondary|Mean Change From Baseline in Heart Rate (HR) at Hour 1, 2, 3 and 4 Post Dose|Hourly changes from baseline in HR were reported.|Baseline, 1, 2, 3, 4 hours post-dose on Day 1|FAS included all randomized participants who received study medication.||beats per minute (bpm)||Standard Deviation|Mean
857548|NCT00853112|Secondary|Mean Change From Baseline in Pulmonary Vascular Resistance (PVR) and Systemic Vascular Resistance (SVR) at Hour 1, 2, 3 and 4 Post Dose|Hourly changes from baseline in PVR and SVR were reported. PVR was calculated by: PVR (Wood units) = (mean PAP minus PCWP) divided by CO (taken as the average of the triplicate measurements). SVR (Wood units) = (mean SAP minus RAP) divided by CO (taken as the average of the triplicate measurements).|Baseline, 1, 2, 3, 4 hours post-dose on Day 1|FAS included all randomized participants who received study medication. Here, 'Number Analyzed' = participants who were evaluable at given time points for each group.||Wood units||Standard Deviation|Mean
857549|NCT00853112|Secondary|Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP), Mean Systemic Arterial Pressure (SAP), Systolic Systemic Arterial Pressure (sSAP) and Diastolic Systemic Arterial Pressure (dSAP) at Hour 1, 2, 3 and 4 Post Dose|Hourly changes from baseline in hemodynamic parameters were reported. Hemodynamic parameters including PCWP, SAP, sSAP and dSAP were measured using a pressure transducer positioned at the mid-axillary line with the participant in the supine position. All hemodynamic pressure measurements (except PCWP for which 1 measurement is sufficient) were performed as triplicate measurements and average was used.|Baseline, 1, 2, 3, 4 hours post-dose on Day 1|FAS included all randomized participants who received study medication. Here, 'Number Analyzed' = participants who were evaluable at given time points for each group.||mmHg||Standard Deviation|Mean
857551|NCT00853112|Secondary|Change From Baseline in Cardiac Index (CI) at Hour 1, 2, 3 and 4 Post Dose|CI was calculated as: CI (liters per minute per square meter [L/min/m^2]) = CO (taken as the average of the triplicate measurements) divided by BSA. BSA (m^2) = (0.007184) multiplied by (height in cm)^0.725 multiplied by (weight in kg)^0.425.|Baseline, 1, 2, 3, 4 hours post-dose on Day 1|FAS included all randomized participants who received study medication. Here, N (overall number of participants analyzed) = participants evaluable for this measure and 'Number Analyzed' = participants who were evaluable at given time points for each group.||L/min/m^2||Standard Deviation|Mean
857552|NCT00853112|Secondary|Change From Baseline in Systemic Vascular Resistance Index (SVRI) at Hour 1, 2, 3 and 4 Post Dose|SVRI is the product of SVR and BSA. SVR equals to (mean SAP subtracted by RAP) divided by CO (taken as the average of the triplicate measurements). BSA (m^2) equals to 0.007184 times height (cm)^0.725 times weight (kilogram) ^0.425. Wood unit equals to 79.9 dyne*second/cm^5. Hourly changes from baseline in SVRI was reported.|Baseline, 1, 2, 3, 4 hours post-dose on Day 1|FAS included all randomized participants who received study medication. Here, N (overall number of participants analyzed) = participants evaluable for this measure and 'Number Analyzed' = participants who were evaluable at given time points for each group.||(dyne*s*m^2)/cm^5||Standard Deviation|Mean
857553|NCT00853112|Secondary|Change From Baseline in Pulmonary Vascular Resistance Index (PVRI) at Hour 1, 2, 3 and 4 Post Dose|PVRI was calculated as: PVR multiplied by BSA. PVR = (mean PAP minus PCWP) divided by CO (taken as the average of the triplicate measurements). BSA (m^2) = 0.007184 times height (cm)^0.725 times weight (kilogram)^0.425. Wood unit equals to 79.9 dyne*second/cm^5. Hourly changes from baseline in PVRI was reported.|Baseline, 1, 2, 3, 4 hours post-dose on Day 1|FAS included all randomized participants who received study medication. Here, N (overall number of participants analyzed) = participants evaluable for this measure and 'Number Analyzed' = participants who were evaluable at given time points for each group.||(dyne*s*m^2)/cm^5||Standard Deviation|Mean
857554|NCT00853112|Secondary|Mean Change From Baseline in Systemic Vascular Resistance Index (SVRI) Over 4 Hours Post Dose|SVRI was calculated as: SVRI (Wood units*m^2) = SVR multiplied by BSA. SVR (Wood units) = (mean SAP minus RAP) divided by CO (taken as the average of the triplicate measurements). BSA (m^2) = (0.007184) multiplied by (height in cm)^0.725 multiplied by (weight in kg)^0.425. SVRI values were converted to dyne*s*m^2/cm^5 from Woods units by multiplying by a factor of 79.9. The change from baseline in SVRI over 4-hour interval was calculated as the average of the change from baseline values at 1, 2, 3, and 4 hours post dose on Day 1.|Baseline, up to 4 hours post-dose on Day 1|FAS included all randomized participants who received study medication. Here, N (overall number of participants analyzed) = participants evaluable for this measure.||(dyne*s*m^2)/cm^5||Standard Deviation|Mean
857555|NCT00853112|Secondary|Greatest Reduction From Baseline in Pulmonary Vascular Resistance Index (PVRI) and Systemic Vascular Resistance Index (SVRI) Over 4 Hours Post Dose|PVRI was calculated as: PVRI (in Wood units*m^2) = PVR multiplied by BSA. PVR (in Wood units) = (mean PAP minus PCWP) divided by CO (taken as the average of the triplicate measurements). SVRI was calculated as: SVRI (Wood units*m^2) = systemic vascular resistance (SVR) multiplied by BSA. SVR (Wood units) = (mean systemic arterial pressure [mean SAP] minus right atrial pressure [RAP]) divided by CO (taken as the average of the triplicate measurements). BSA (m^2) = (0.007184) multiplied by (height in cm)^0.725 multiplied by (weight in kg)^0.425. PVRI and SVRI values were converted to dyne*s*m^2/cm^5 from Woods units by multiplying by a factor of 79.9. For each participant the greatest reduction (GR) from baseline in PVRI and SVRI over 4-hour interval was defined as the maximum reduction (greatest decrease or smallest increase) observed at 1, 2, 3, and 4 hours post dose on Day 1.|Baseline, up to 4 hours post-dose on Day 1|Full analysis set (FAS) included all randomized participants who received study medication. Here, N (overall number of participants analyzed) = participants evaluable for this measure and 'Number Analyzed' = participants who were evaluable at given time points for each group.||(dyne*s*m^2)/cm^5||Standard Deviation|Mean
857556|NCT00853112|Primary|Mean Change From Baseline in Pulmonary Vascular Resistance Index (PVRI) Over 4 Hours Post Dose|PVRI was calculated as: PVRI (in Wood units*meter^2 [m^2]) = pulmonary vascular resistance (PVR) multiplied by body surface area (BSA). PVR (in Wood units) = (mean pulmonary artery pressure [mean PAP] minus pulmonary capillary wedge pressure [PCWP]) divided by cardiac output (CO, taken as the average of the triplicate measurements). BSA (m^2) = (0.007184) multiplied by (height in centimeters [cm])^0.725 multiplied by (weight in kilograms [kg])^0.425. PVRI values were converted to dyne*second (s)*m^2/centimeter (cm)^5 from Woods units by multiplying by a factor of 79.9. The change from baseline in PVRI over 4-hour interval was calculated as the average of the change from baseline values at 1, 2, 3, and 4 hours post dose on Day 1.|Baseline, up to 4 hours post-dose on Day 1|Full analysis set (FAS) included all randomized participants who received study medication. Here, N (overall number of participants analyzed) = participants evaluable for this measure and 'Number Analyzed' = participants who were evaluable at given time points for each group.||(dyne*s*m^2)/cm^5||Standard Deviation|Mean
857582|NCT00788697|Secondary|Specific Diagnosis of Malignant FLLs|"SonoVue-enhanced versus unenhanced ultrasound for specific diagnosis of malignant FLLs, using the diagnosis provided by each of the 3 off-site assessors (blinded to patient data) for the ITD population. Unit of analysis was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized.
Among the 124 ITD participants with malignant lesions based on the truth standard, only 115 participants (lesions) were characterized as either hepatocellular carcinoma (HCC) lesions or metastatic lesions.
Truth standard: CE-CT and /or CE-MRI examination OR tissue pathology/histology from surgical resection/biopsy OR 6-month follow up. Calculated as (number of correctly characterized lesions/number of lesions per truth standard) x 100."|24 hours to 6 months|||Malignant lesions|Malignant lesions to be characterized||Number
857583|NCT00788697|Secondary|Negative Predictive Value (NPV)|"Negative Predictive Value of SonoVue-enhanced versus unenhanced ultrasound for characterization of FLLs, using the diagnosis provided by each of the 3 off-site assessors (blinded to patient data) for the ITD population. Unit of analysis was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized.
True negative: subject with a target lesion characterized as benign by both ultrasonography and the truth standard.
Among the 240 ITD participants, the number of participants (lesions) assessed as benign varied based on the evaluation of the UE-US and CE-US made by each off-site Reader.
Truth standard: CE-CT and /or CE-MRI examination OR tissue pathology/histology from surgical resection/biopsy OR 6-month follow up. Calculated as (number of true negative lesions/number of benign lesions per ultrasound) x 100."|24 hours to 6 months|||Percent negative lesions by ultrasound|Negative lesions|95% Confidence Interval|Number
857584|NCT00788697|Secondary|Positive Predictive Value (PPV)|"Positive Predictive Value of SonoVue-enhanced versus unenhanced ultrasound for characterization of FLLs, using the diagnosis provided by each of the 3 off-site assessors (blinded to patient data) for the ITD population. Unit of analysis was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized.
True positive: subject with a target lesion characterized as malignant by both ultrasonography and the truth standard.
Among the 240 ITD participants, the number of participants (lesions) assessed as malignant varied based on the evaluation of the UE-US and CE-US made by each off-site Reader.
Truth standard: CE-CT and /or CE-MRI examination OR tissue pathology/histology from surgical resection/biopsy OR 6-month follow up. Calculated as (number of true positive lesions/number of malignant lesions per ultrasound) x 100."|24 hours to 6 months|||Percent positive lesions by ultrasound|Positive lesions|95% Confidence Interval|Number
857585|NCT00788697|Secondary|Accuracy|"The Accuracy of SonoVue-enhanced versus unenhanced ultrasound for characterization of malignant and benign FLLs, using the diagnosis provided by each of the 3 off-site assessors (blinded to patient data) for the ITD population Unit of analysis was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized.
True positive: subject with a target lesion characterized as malignant by both ultrasonography and the truth standard.
True negative: subject with a target lesion characterized as benign by both ultrasonography and the truth standard.
Truth standard: CE-CT and /or CE-MRI examination OR tissue pathology/histology from surgical resection/biopsy OR 6-month follow up. Calculated as (number of true positive and true negative lesions/number of total lesions per truth standard) x 100."|24 hours to 6 months|||Percent true positive and negative lesio|Total lesions|95% Confidence Interval|Number
857586|NCT00788697|Primary|Specificity|"Specificity of SonoVue-enhanced versus unenhanced ultrasound for characterization of benign FLLs, using the diagnosis provided by each of the 3 off-site assessors (blinded to patient data) for the ITD population. Unit of analysis was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized.
True negative: subject with a target lesion characterized as benign by both ultrasonography and the truth standard.
Among the 240 ITD participants, only 116 participants (lesions) were benign based on the truth standard.
Truth standard: CE-CT and /or CE-MRI examination OR tissue pathology/histology from surgical resection/biopsy OR 6-month follow up. Calculated as (number of true negative lesions/number of benign lesions per truth standard) x 100."|24 hours to 6 months|||Percentage of true negative lesions|Benign lesions|95% Confidence Interval|Number
857587|NCT00788697|Primary|Sensitivity|"Sensitivity of SonoVue-enhanced ultrasound (SonoVue CE-US) versus unenhanced ultrasound (UE-US) for characterization of malignant focal liver lesions (FLLs), using the diagnosis provided by each of the 3 off-site assessors (blinded to patient data) for the Intent-to-Diagnose (ITD) population. Unit of analysis was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized.
True positive: subject with a target lesion characterized as malignant by both ultrasonography and the truth standard.
Among the 240 ITD participants, only 124 participants (lesions) were malignant based on the truth standard.
Truth standard: contrast-enhanced computed tomography (CE CT) and /or contrast-enhanced magnetic resonance imaging (CE-MRI) examination OR tissue pathology/histology from surgical resection/biopsy OR 6-month follow up. Calculated as (number of true positive lesions/number of malignant lesions per truth standard) x 100."|24 hours to 6 months|||Percentage of true positive lesions|Malignant lesions|95% Confidence Interval|Number
857671|NCT00470366|Primary|Rate of Complete Response|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions|3 years|||Participants|||Count of Participants
857627|NCT00596011|Other Pre-specified|Effect of Polyphenon E on the Fundamental Molecular Pathways|Explore the effects of Polyphenon E on the fundamental molecular pathways contributing to chemopreventive activity of Polyphenon E in the prostate. This exploratory aim is ongoing.|12 months||||||
857628|NCT00596011|Other Pre-specified|Change in Scores - Lower Urinary Tract Symptom (LUTS)|Change in score from baseline to 1 year. LUTS represent a common conglomeration of storage, voiding, and post-micturition symptoms with reported debilitating effect on quality of life. Symptom severity related to urinary frequency, nocturia, weak urinary stream, hesitancy, intermittency, incomplete bladder emptying and urinary urgency are assessed. We utilized the American Urological Association Symptom Score for the evaluation LUTS in this patient population. Symptom Frequency Scores: 0 = Not at all, 1 = Less than 1 time in 5, 2 = Less than half the time, 3 = About half the time, 4 = More than half the time, 5 = Almost always. Total Symptom Score = Sum of individual scores of the 7 symptoms. (minimum possible score=0; maximum possible score =35; Range of scores and significance: 0-7 mild symptoms; 8-19 moderate symptoms; 20-35 severe symptoms.|1 year|Participants with LUTS symptom scores available at baseline and at one year||units on a scale||Standard Deviation|Mean
857629|NCT00596011|Secondary|Median Serum Total Prostatic Specific Antigen (tPSA)|Median ng/mL serum tPSA post treatment, per treatment arm.|12 months|All participants||ng/mL||95% Confidence Interval|Median
857630|NCT00596011|Secondary|Occurrence of Grade 3 or Higher Adverse Events (AEs)|Number of participants with AEs grade 3 or higher, per treatment arm.|12 months|All participants||participants|||Number
857631|NCT00596011|Secondary|Treatment Emergent Adverse Events (AEs)|Safety of Polyphenon E (200 mg EGCG bid for one year) in men with HGPIN or ASAP. Number of participants with AEs Possibly or Probably related to treatment.|12 months|All participants||participants|||Number
857632|NCT00596011|Primary|Rate of Progression From HGPIN to ASAP or PCa|Analyses of participants reaching a definitive endpoint. Number of baseline HGPIN participants who progressed to ASAP or PCa.|12 months|Baseline HGPIN participants||participants|||Number
857633|NCT00596011|Primary|Rate of Progression to Prostate Cancer (PCa)|Number of participants with diagnosis of high-grade prostatic intraepithelial neoplasia (HGPIN) or atypical small acinar proliferation (ASAP) who progressed to prostate cancer (PCa) at one year.|12 months|All participants||participants|||Number
857669|NCT00470366|Secondary|Participants' Overall Response|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions|3 years|Of the 60 participants, 56 were evaluable for response.||Participants|||Count of Participants
857665|NCT00575042|Secondary|Quality of Life According to NIDDK Questionnaire||1 year||||||
857666|NCT00575042|Primary|Serum Level of Alkaline Phosphatase|We analyzed whether there was a difference in median ALP at 1 year compared to baseline values.|1 year|||U/L||Full Range|Median
857667|NCT00470366|Secondary|Number of Patients With Treatment Related Toxicity|Toxicity evaluated and graded according to the National Cancer Institute, Version 3.0|3 years|||Participants|||Count of Participants
857668|NCT00470366|Secondary|Percentage of Participants With Progression Free Survival|Progression Free Survival at 3 years. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|3 years|||percentage of patients||95% Confidence Interval|Number
857734|NCT00116428|Secondary|Percentage of Subjects Who Experienced Atrial Fibrillation Recurrence During the Two-year Follow up.|At the 2 year follow-up visit, Atrial Fibrillation recurrence was assessed by subject interview without documentation.|During the two years of post procedure|Subjects who completed two years follow up||Percentage of Participants|||Number
857735|NCT00116428|Secondary|The Percentage of Subjects Who Achieved Acute Success.|Acute success was defined as confirmation of entrance block in all targeted pulmonary veins. The study protocol considered subjects that had more than 2 AF ablation procedures within the 90 day blanking period immediately following their index study procedure or subjects that had additional ablation procedures greater than 80 days following their original study ablation procedure as acute failures.|90 days post study procedure|This analysis population is based on the first study ablation procedure.||Percentage of participants|||Number
857736|NCT00116428|Primary|The Percentage of Subjects Who Experienced Incidences of Early Onset (Within 7 Days of Ablation Procedure) Serious Catheter-related Adverse Events|Catheter-related adverse events include death, myocardial infarction, pulmonary vein stenosis,diaphragmatic paralysis, atrio-esophageal fistula,transient ischemic attack,stroke,cerebrovascular accident, thromboembolism, pericarditis, cardiac tamponade,pericardial effusion,pneumothorax,atrial perforation,vascular access complications,pulmonary edema,hospitalization (initial and prolonged), and heart block.|Within 7 Days of Ablation Procedure|Analysis population includes those enrolled subjects undergoing a study ablation procedure. A total of 139 underwent the procedure, including 36 AAD (control) group subjects who underwent the procedure after failing the effectiveness endpoint. The remaining 25 AAD (control) subjects didn't have the ablation procedure.||Percentage of Participants|||Number
857737|NCT00116428|Primary|The Percentage of Chronic Success of the NAVISTAR THERMOCOOL Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (PAF)|Chronic success was defined as freedom of documented symptomatic Atrial Fibrillation episodes based on electrocardiographic data and no changes in antiarrhythmic drugs (AAD) regimen during comparable evaluation periods for the THERMOCOOL and AAD (Control) groups through 12 and 9 months of follow-up, respectively.|The evaluation time frame for the THERMOCOOL catheter subjects is 91-361 days (12 months) post procedure; for Antiarrhythmic Drug Therapy subjects the time frame is 15-285 days (9 months) post procedure.|||Percentage of participants|||Number
858147|NCT01665599|Secondary|Pharmacokinetics of Total Testosterone Measuring Average Steady State Concentration (Cave)|A validated LC/MS/MS method was used to determine the levels of total testosterone.|Day 1; Day 90|ITT population was used which comprised of all participants who received at least one dose of IMP.||ng/dL||Standard Deviation|Mean
859178|NCT01002742|Secondary|Incidence of GVHD Flares Requiring Increased Therapy|Flares are defined as any progression of acute GVHD after an initial response (i.e., earlier CR or PR) that requires re-escalation of steroid dosing, or initiation of additional topical or systemic therapy.|Day 90|||participants|||Number
859179|NCT01002742|Secondary|Percentage of Surviving Participants With Complete Response (CR)|CR is defined as a score of 0 for the GVHD grading in all evaluable organs.|Days 14, 28, and 56|||percentage of participants|||Number
859180|NCT01002742|Primary|GVHD-free Survival|Success is defined as alive and free of GVHD at day 56 after randomization, all others are considered to be a study failure.|Day 56|||participants|||Number
859181|NCT00912223|Secondary|Serum Rituximab (RTX) Levels|RTX concentration levels within participants|Baseline, Days 28 and 365|Serum RTX concentrations were collected at baseline (n=57), day +28 (n=56), and day +365 (n=44) for a compliance rate of 92%, 90%, and 80% at the assigned time points.||ng/mL||Full Range|Median
859182|NCT00912223|Secondary|Incidence of Toxicities|Number of participants that experiences at least one grade 3 - 5 toxicity during the first two years, where grade 5 is worst. Toxicity grades are based on the NCI CTCAE Version 3.0.|Year 2|||participants|||Number
859183|NCT00912223|Secondary|Immunologic Reconstitution|Quantitative immunoglobulins (IgG)|Year 1|||mg/dL||Full Range|Median
859184|NCT00912223|Secondary|Quality of Life||Year 2|No data collected|||||
859185|NCT00912223|Secondary|Infections||Year 2|no data collected|||||
859186|NCT00912223|Secondary|Treatment-related Mortality (TRM)|The event is death occurring in patients in continuous complete remission. The TRM distribution will be estimated by the Kaplan-Meier curve.|Year 3|||percentage of participants||95% Confidence Interval|Number
859187|NCT00912223|Secondary|Overall Survival|The event is death from any cause.|Years 2 and 3|||percentage of participants||95% Confidence Interval|Number
859188|NCT00912223|Secondary|Chronic GVHD|The event is the incidence and severity of chronic GVHD from day of transplant, a cumulative incidence curve will be computed along with a 95% confidence interval at two years post-transplant. Death prior to occurrence of chronic GVHD will be considered as a competing risk.|Year 2|||percentage of participants||95% Confidence Interval|Number
859189|NCT00912223|Secondary|Acute Graft-versus-Host Disease (GVHD)|The event is the incidence of grades II-IV acute GVHD from day of transplant, where grade IV is worst. The first day of acute GVHD onset at a certain grade will be used to calculate a cumulative incidence curve for that acute GVHD grade. GVHD should be monitored in accordance with BMT CTN manual of procedures guidelines. Acute GVHD grading was based on the consensus conference criteria (Przepiorka, et. al., 1994) and the Center for International Blood and Marrow Transplant Research (CIBMTR) grading criteria.|Day 100|||percentage of participants||95% Confidence Interval|Number
859190|NCT00912223|Secondary|Time to Neutrophil Recovery|Neutrophil Recovery is defined as ANC > 500/mm^3 for 3 consecutive days.|Day 60|||days||Full Range|Median
859191|NCT00912223|Secondary|Donor Cell Engraftment|Donor engraftment is defined as > 5% donor peripheral blood T cell chimerism by Day +30 post-transplant in the setting of Absolute Neutrophil Count (ANC) recovery (ANC >500/mm^3 for 3 consecutive days).|Days 30 and 100|||percentage of donor T-cell chimerism||Full Range|Median
859192|NCT00912223|Secondary|Graft Failure|Primary graft failure is defined as a donor peripheral blood T cell chimerism < 5% at Day +30 post-transplant. Secondary Graft Failure is defined as documented engraftment followed by loss of graft as defined by donor peripheral blood T cell chimerism < 5%.|Day 30|||participants|||Number
859193|NCT00912223|Primary|Progression-Free Survival (PFS)|Patients are considered a failure for this endpoint if they die, or if they relapse/progress or receive anti-lymphoma therapy not including planned post-transplant radiation.|Year 2|||percentage of participants||95% Confidence Interval|Number
859194|NCT00910962|Secondary|Mean Hyperenhancement Score Index at Week 12|The myocardium was divided into 17 segments. A score ranging from 0 to 4 was visually attributed to each of the 17 segments according to the transmural extent of the hyperenhancement: score 0=0%, 1=>0-25%, 2=>25-50%, 3=>50-75% and 4=>75-100%. All these 17 scores were summed. The resulting summed score ranged in theory from 0 to 68 and was thereafter expressed as a percentage of the maximum possible score of 68. Cardiac MRIs were performed at qualified sites on participants who agree to participate in the MRI sub-study. A total of 15 participants out of 93 MRI ITT participants were excluded from the analysis due to missing Baseline cTnI (10 participants) and onset chest pain duration (9 participants). Four participants had both covariate values missing. Statistical analysis was performed on LS mean value using repeated measures ANCOVA.|At week 12|MRI ITT Population. Only those participants with data available at week 12 were analyzed.||Scores on a scale||Standard Deviation|Mean
859195|NCT00910962|Secondary|Mean Regional Wall Motion Score Index at Week 12|Wall motion score index is a semi-quantitative analysis of regional systolic function. Each segment is analyzed individually and scored on the basis of its motion and systolic thickening. This score is a 5-level score defines as: 1=normokinesis or hyperkinesis, 2=hypokinesi, 3=akinesis, 4=dyskinesis, 5=aneurysm. Wall motion score index is derived as a sum of all scores divided by the number of segments visualized. Larger score index indicates higher degree of abnormalities. Cardiac MRIs were performed at qualified sites on participants who agree to participate in the MRI sub-study. A total of 15 participants out of 93 MRI ITT participants were excluded from the analysis due to missing Baseline cTnI (10 participants) and onset chest pain duration (9 participants). Four participants had both covariate values missing.|At Week 12|MRI ITT Population. Only those participants with data available at the indicated time points were analyzed.||Scores on a scale||Standard Deviation|Mean
859196|NCT00910962|Secondary|Mean Left Ventricular Mass at Week 12|Statistical analyses of the treatment differences was performed to compare the left ventricular mass (via MRI) at Week 12, and for the change from Day 3 to Week 12 via repeated measures ANCOVA between study drug and placebo.Cardiac MRIs were performed at qualified sites on participants who agree to participate in the MRI sub-study. A total of 15 participants out of 93 MRI ITT participants were excluded from the analysis due to missing Baseline cTnI (10 participants) and onset chest pain duration (9 participants). Four participants had both covariate values missing.|At Week 12|MRI ITT Population. Only those participants with data available at the indicated time points were analyzed.||grams (gm)||Standard Deviation|Mean
857774|NCT00003659|Secondary|Overall Survival Status|The 5 year survival rate. The survival of patients with this disease is dependent on the stage of disease. Two useful staging systems are: Three-stage Rai System Clinical Feature and the Binet System.|up to 5 years|All assessable patients as indicated in the protocol.||participants|||Number
857775|NCT00003659|Secondary|Utilize Flow Cytometry and Polymerase Chain Reaction as Sensitive Measures of Minimal Residual Disease|The flow cytometric response and the molecular polymerase chain reaction (PCR) response was captured as indicated in the protocol. Immunophenotypic analysis of bone marrow and/ or peripheral blood demonstrate a normal k:λ ratio and a normal number of CD5/CD19 (or CD5/CD20) dual staining cells (<5% of the lymphocyte gate).|3 years|All assessable patients as indicated in the protocol||participants|||Number
857776|NCT00003659|Primary|Overall Response Rate|Response was determined as indicated in the protocol. The categories are: complete response, nodular partial response, partial response and failure. The major criteria for determination of response to therapy in patients with CLL include physical examination and examination of the peripheral blood and bone marrow. The laboratory and radiographic studies which were abnormal pre-study, will be repeated to document the degree of maximal response.|3 years|There were 36 assessable patients as described in the protocol||participants|||Number
857777|NCT00038727|Secondary|Quality of Life and Economic Analyses|Quality of life measurements include Beck, SF-36, and QWB.|2002-2013||||||
857778|NCT00038727|Secondary|Subclinical Atherosclerosis|Measured using coronary artery calcification.|2012||||||
857779|NCT00038727|Secondary|Aging Related Outcomes - Cognitive and Physical Function|Cognitive function defined as a composite measure constructed from tests of memory (English Spanish Verbal Learning Test) and executive function (word fluency and Digit Symbol Substitution Test ). Physical function assessed with the same two well-validated composite measures : the Short Physical Performance Battery (SPPB) and the Cardiovascular Health Study Frailty criteria. The SPPB is comprised of measures of 1) time to walk 3-4 meters, 2) balance, i.e., side-by-side stand, semi-tandem stand, and tandem stand, and 3) repeated chair stands. Frailty is classified based on 5 frailty characteristics: slow walking speed, low energy expenditure, exhaustion, weak grip strength, and unintentional weight loss.|2010 and 2012||||||
857780|NCT00038727|Secondary|Microvascular and Cardiovascular Disease Risk Factors|Blood pressure, lipids, medication use, weight, insulin resistance, HbA1c, physical activity by MAQ.|2021||04/2022||||
857781|NCT00038727|Primary|MACE|Defined as MI, stroke and CVD death|1996-2025||06/2025||||
857782|NCT00038727|Primary|Total Cancer Except Non-melanoma Skin Cancer|All primary incident cancers except non-melanoma skin cancer|1996-2021||06/2021||||
857783|NCT00038727|Primary|Prevalence of Aggregate Microvascular Complication|Aggregate microvascular disease is defined as the average prevalence of 3 components: (1) retinopathy measured by photography (ETDRS of 20 or greater); (2) neuropathy detected by Semmes Weinstein 10 gram monofilament, and (3) nephropathy based on eGFR by CKD-Epi (<45 ml/min, confirmed) and albumin-to-creatinine ratio in spot urine (> 30mg/gm, confirmed).|2012-2013|Number with microvascular outcome data and included in the primary outcome analysis||average percentage of participants||95% Confidence Interval|Number
857784|NCT00038727|Primary|Development of Diabetes.|Primary outcome for years 2002-2008 defined according to American Diabetes Association criteria (fasting plasma glucose level >= 126 mg/dL [7.0 mmol/L] or 2-hour plasma glucose >= 200 mg/dL [11.1 mmol/L], after a 75 gram OGTT, and confirmed with a repeat test).|2008|||diabetes incidence (cases per 100 person||95% Confidence Interval|Number
857785|NCT03044431|Other Pre-specified|Number of Participants With Interstitial Lung Disease Reporting an Improvement in 6 Month-Post Treatment QOL Scores|Number of patients with a diagnosis of Interstitial Lung Disease who reported an improved perceived quality of life 6 months post-treatment as measured by the Clinical COPD Questionnaire (CCQ).|Measurements for ILD pre-treatment and then at 6 months post-treatment|23 patients with ILD completed a 6 month post-treatment QOL survey||Participants|||Count of Participants
857786|NCT03044431|Other Pre-specified|Number of Participants With Interstitial Lung Disease Reporting an Improvement in 3 Month-Post Treatment QOL Scores|Number of patients with a diagnosis of Interstitial Lung Disease who reported an improved perceived quality of life 3 months post-treatment as measured by the Clinical COPD Questionnaire (CCQ).|Measurements for ILD pre-treatment and then at 3 months post-treatment|28 patients with ILD completed a 3 month post-treatment QOL survey||Participants|||Count of Participants
857787|NCT03044431|Other Pre-specified|Number of Participants With COPD Reporting an Improvement in 6 Month-Post Treatment QOL Scores|Number of patients with a diagnosis of COPD who reported an improved perceived quality of life 6 months post-treatment as measured by the Clinical COPD Questionnaire (CCQ).|Measurements for COPD pre-treatment and then at 6 months post-treatment|101 patients with COPD completed a 6 month post-treatment QOL survey||Participants|||Count of Participants
857788|NCT03044431|Other Pre-specified|Number of Participants With COPD Reporting an Improvement in 3 Month-Post Treatment QOL Scores|Number of patients with a diagnosis of COPD who reported an improved perceived quality of life 3 months post-treatment as measured by the Clinical COPD Questionnaire (CCQ).|Measurements for COPD pre-treatment and then at 3 months post-treatment|120 patients with COPD completed a 3 month post-treatment QOL survey||Participants|||Count of Participants
857789|NCT03044431|Primary|Number of Participants Reporting an Improvement in 6 Month-Post Treatment QOL Scores, All Diagnoses|Number of patients in the total sample who reported an improved perceived quality of life 6 months post-treatment as measured by the Clinical COPD Questionnaire (CCQ).|Measurements pre-treatment and then at 6 months post-treatment among all diagnoses|124 patients completed a 6 month post-treatment QOL survey||Participants|||Count of Participants
857790|NCT03044431|Primary|Number of Participants Reporting an Improvement in 3 Month-Post Treatment QOL Scores, All Diagnoses|Number of patients in the total sample who reported an improved perceived quality of life 3 months post-treatment as measured by the Clinical COPD Questionnaire (CCQ).|Measurements pre-treatment and then at 3 months post-treatment for all diagnoses|148 of 207 enrolled participants completed the 3 month post-treatment QOL survey||Participants|||Count of Participants
857791|NCT03044431|Primary|Change in FEV1 From Baseline Among COPD Patients|Change from baseline (among COPD patients only) as measured by pulmonary function testing/spirometry at baseline and again at 6 months post- treatment|Measurements pre-treatment and then at 6 months post- treatment|All patients with COPD were asked to provide a 6 month post-treatment pulmonary function test. 5 participants completed and returned the test.||percentage of change in FEV1||Full Range|Mean
857792|NCT02798289|Primary|Tear Meniscus Height Captured by Optical Coherence Tomography|Tear meniscus Height was measured before and after stimulation with Oculeve Intranasal Neurostimulator using Optical Coherence Tomography.|Day 1|Safety population included all subjects who received device intervention.||µm||Standard Deviation|Mean
857793|NCT02750943|Secondary|Number of Participants With Visible Blood in Expectorate (Presence [Trace, Substantial]/Absence) at Week4 and Week 12|Visible blood in expectorate for each participant was classified as (i) Present (Trace or Substantial) (ii) Absent. The number of participants with blood ‘Present’ (Trace or Substantial) or ‘absent’ in expectorate was analyzed.|Week 4, Week 12|Intent to treat (ITT) population which included all participants who were randomized, received at least one dose of study product and had at least one post-baseline efficacy measurement. Number of participants analyzed is the number of participants from ITT population evaluated for this outcome at specific time points for respective treatment arm.||number of participants|||Number
857794|NCT02750943|Secondary|Modified Gingival Index (MGI) at Week 4 and Week 12|MGI was assessed on facial and lingual surfaces at two sites on each tooth (papillae and margin). The scoring of the MGI was performed under dental office conditions using a standard dental light for illuminating the oral cavity. This procedure was performed by a single examiner. The MGI scoring system is as follows: 0 = absence of inflammation; 1 = mild inflammation; slight change in color, little change in color; little change in texture of any portion of the marginal or papillary gingival unit; 2 = mild inflammation; criteria as above but involving the entire marginal or papillar gingival units; 3= moderate inflammation; glazing, redness, edema, and/ or hypertrophy of the marginal or papillary gingival unit; 4 = severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration.|Week 4, Week 12|Intent to treat (ITT) population which included all participants who were randomized, received at least one dose of study product and had at least one post-baseline efficacy measurement. Number of participants analyzed is the number of participants from ITT population evaluated for this outcome at specific time points for respective treatment arm.||score on a scale||Standard Error|Least Squares Mean
857795|NCT02750943|Secondary|Bleeding Index (BI) at Week 4 and Week 12|BI was assessed by a single examiner using a color coded periodontal probe. The probe was engaged approximately 1mm into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system to be used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed|Week 4, Week 12|Intent to treat (ITT) population which included all participants who were randomized, received at least one dose of study product and had at least one post-baseline efficacy measurement. Number of participants analyzed is the number of participants from ITT population evaluated for this outcome at specific time points for respective treatment arm.||score on a scale||Standard Error|Least Squares Mean
857796|NCT02750943|Secondary|Number of Bleeding Sites at Week 4|Number of bleeding sites was measured as BI via a single examiner using a color coded periodontal probe. The probe was engaged approximately 1 mm into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI was assessed on the facial and lingual gingival surfaces of each scorable tooth (7-7 in each arch). The BI scoring system used to measure bleeding sites is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed. Bleeding sites were assessed as the number of bleeding sites with a BI score of 1 or 2.|Week 4|Intent to treat (ITT) population which included all participants who were randomized, received at least one dose of study product and had at least one post-baseline efficacy measurement. Number of participants analyzed is the number of participants from ITT population evaluated for this outcome at Week 4 for respective treatment arm.||number of bleeding sites||Standard Error|Least Squares Mean
857797|NCT02750943|Primary|Number of Bleeding Sites at Week 12|Number of bleeding sites was measured as bleeding index (BI) via a single examiner using a color coded periodontal probe. The probe was engaged approximately 1 millimetre (mm) into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI was assessed on the facial and lingual gingival surfaces of each scorable tooth (7-7 in each arch). The BI scoring system used to measure bleeding sites is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed. Bleeding sites were assessed as the number of bleeding sites with a BI score of 1 or 2.|Week 12|Intent to treat (ITT) population which included all participants who were randomized, received at least one dose of study product and had at least one post-baseline efficacy measurement. Number of participants analyzed is the number of participants from ITT population evaluated for this outcome at Week 12 for respective treatment arm.||number of bleeding sites||Standard Error|Least Squares Mean
857808|NCT02643862|Secondary|Sustained Unresponsiveness to Increased Doses Measured by Proportion of FA Participants Who Pass a DBPCFC to 4,000 mg Each of 2 Allergens at Week 36|"Proportion of FA participants who pass a DBPCFC to 4,000 mg each of 2 allergens at week 36.
Greater than 3 foods at 36 weeks for
Xolair: 21/26 (80.8%) Placebo: 2/7 (28.6%)"|36 weeks|We analyzed an ITT||Participants|||Count of Participants
857809|NCT02643862|Primary|Tolerance Measured by Proportion of Food Allergic (FA) Participants Who Pass a DBPCFC to 2,000 mg Protein for Each of 2 Allergens at Week 36|"Proportion of food allergic (FA) participants who pass a DBPCFC to 2,000 mg protein for each of 2 allergens at week 36.
Xolair arm: 30/36 (83.3%) Placebo arm: 4/12 (33.3%)"|36 weeks|this is an ITT population||Participants|||Count of Participants
857810|NCT02642432|Secondary|Percentage of Participants With Post-treatment Relapse|Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment, excluding reinfection.|From the end of treatment through 12 weeks after the last dose of study drug|All participants who received at least 1 dose of study drug, completed treatment, and had HCV RNA <LLOQ at the final treatment visit.||percentage of participants||95% Confidence Interval|Number
857811|NCT02642432|Secondary|Percentage of Participants With On-treatment Virologic Failure|On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.|Treatment Weeks 1, 2, 4, 8, and 12 (end of treatment) or premature discontinuation from treatment|All participants who received at least 1 dose of study drug (ITT population).||percentage of participants||95% Confidence Interval|Number
857812|NCT02642432|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of study drug|Intent-to-treat (ITT) population: all participants who received at least 1 dose of study drug; participants with missing data after backwards imputation were imputed as nonresponders.||percentage of participants||95% Confidence Interval|Number
857833|NCT02513160|Secondary|Participants With Treatment-Emergent Adverse Events (TEAE)|An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an inability to carry out usual activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly/birth defect, or an important medical event that may not result in death, be life-threatening, or require hospitalization, but may jeopardize the patient and may require medical intervention to prevent one of the outcomes listed in this definition.|Day 0 to Week 6|The safety analysis set included all randomly assigned patients (ITT analysis set) who received at least 1 dose of study drug. In this analysis set, treatment was assigned based on the treatment patients actually received, regardless of the treatment to which they were randomly assigned.||Participants|||Count of Participants
857834|NCT02513160|Secondary|Count of Participants Withdrawn From Study Drug Treatment Due to Meeting Stopping Criteria for Worsening Asthma|"Number of participants who were withdrawn from study drug due to worsening asthma. Alert criteria for individual patients with worsening asthma were designed to ensure patient safety. The investigator determined whether the patient’s overall clinical picture was consistent with worsening asthma and if the patient should be withdrawn from study drug treatment (but not the study) and be placed on appropriate asthma therapy in the interest of patient safety. An example of an alert criteria is:
Morning FEV1 by handheld spirometer as measured at home falls below the FEV1 stability limit (FEV1 <80%) as calculated at the screening visit for the Run-in Period and at the randomization visit (Day 0) for the Treatment Period on 4 or more days out of any 7-day period."|Day 0 to Week 6|The modified intent-to-treat (mITT) analysis set included all patients in the ITT analysis set and included the available data for those patients until they discontinued study drug treatment at treatment visit week 6 or last available study visit.||Participants|||Count of Participants
857835|NCT02513160|Secondary|Change From Baseline in Weekly Average of Total Daily Asthma Symptom Score Over the 6-Week Treatment Period|Asthma symptom scores were recorded in the patient’s diary each morning and evening before determining FEV1 and PEF and before administration of study or rescue medications. The Daytime Symptom Score was recorded in the evening on a scale of 0 (No symptoms during the day) to 5 (Symptoms so severe that I could not go to work or perform normal daily activities) plus the Nighttime Symptom Score in the morning on a scale of 0 (No symptoms during the night) to 4 (Symptoms so severe that I did not sleep at all) for a total score range of 0-9. Baseline was defined as the average of recorded daily asthma symptom scores (average of daytime and nighttime score) over the 7 days prior to the first dose of double-blind study treatment, including the morning assessment at the randomization visit. The LS means, difference of LS means and its 95% CI, and p value are obtained from the mixed model for repeated measures analysis with covariate adjustment for baseline, sex, age, current asth|Baseline (Day -7 to Day 0 which is part of the Run-in Period); Treatment Period from Day 0 up to 6 weeks|The modified intent-to-treat (mITT) analysis set included all patients in the ITT analysis set and included the available data for those patients until they discontinued study drug treatment at treatment visit week 6 or last available study visit.||units on a scale||Standard Error|Least Squares Mean
857836|NCT02513160|Secondary|Change From Baseline in Weekly Average of Total Daily (24-Hour) Rescue Medication Use Over the 6-Week Treatment Period|Change from baseline in the weekly average of total daily (24-hour) use of albuterol/salbutamol inhalation aerosol over weeks 1 through 6. Patients recorded the number of inhalations (puffs used) of rescue medication (albuterol/salbutamol HFA MDI [90 mcg ex-actuator] or equivalent) each morning and evening in the diary. The average number of daily inhalations over the 7 days before the randomization visit was the baseline value and was compared with the rescue medication use during the 6-week treatment period.|Baseline (Day -7 to Day 0 which is part of the Run-in Period); Treatment Period from Day 0 up to 6 weeks|The modified intent-to-treat (mITT) analysis set included all patients in the ITT analysis set and included the available data for those patients until they discontinued study drug treatment at treatment visit week 6 or last available study visit.||number of inhalations||Standard Error|Least Squares Mean
857837|NCT02513160|Secondary|Change From Baseline in Weekly Average of Daily Trough Morning Forced Expiratory Volume in One Minute (FEV1) Rate Over the 6-Week Treatment Period|Change from baseline in the weekly average of daily trough morning (pre-dose and pre-rescue bronchodilator) FEV1 by handheld spirometer over the 6-week treatment period. FEV1 were determined twice daily, in the morning and in the evening, before administration of study drug or rescue medications. A handheld spirometer was provided to patients and used to determine the morning and evening FEV1 throughout the study. The spirometer was programmed to record the highest FEV1 obtained from 3 valid attempts. Baseline was defined as the average of recorded trough morning FEV1 assessments over the 7 days prior to the first dose of double-blind study treatment, including the morning assessment at the randomization visit. The LS means, difference of LS means and its 95% confidence interval, and p value are obtained from the mixed model for repeated measures analysis with covariate adjustment for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Baseline (Day -7 to Day 0 which is part of the Run-in Period); Treatment Period from Day 0 up to 6 weeks|The modified intent-to-treat (mITT) analysis set included all patients in the ITT analysis set and included the available data for those patients until they discontinued study drug treatment at treatment visit week 6 or last available study visit.||milliliters||Standard Error|Least Squares Mean
857838|NCT02513160|Secondary|Change From Baseline in Weekly Average of Daily Trough Morning Peak Expiratory Flow (PEF) Rate Over the 6-Week Treatment Period|Change from baseline in the weekly average of daily trough morning (pre-dose and pre-rescue bronchodilator) PEF by handheld spirometer over the 6-week treatment period. PEF were determined twice daily, in the morning and in the evening, before administration of study drug or rescue medications. A handheld spirometer was provided to patients and used to determine the morning and evening PEF throughout the study. The spirometer was programmed to record the highest PEF obtained from 3 valid attempts. Baseline was defined as the average of recorded trough morning PEF assessments over the 7 days prior to the first dose of double-blind study treatment, including the morning assessment at the randomization visit. The LS means, difference of LS means and its 95% confidence interval, and p value are obtained from the mixed model for repeated measures analysis with covariate adjustment for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Timeframes: Baseline (Day -7 to Day 0 which is part of the Run-in Period); Treatment Period from Day 0 up to 6 weeks|The modified intent-to-treat (mITT) analysis set included all patients in the ITT analysis set and included the available data for those patients until they discontinued study drug treatment at treatment visit week 6 or last available study visit.||liters/minute||Standard Error|Least Squares Mean
857839|NCT02513160|Primary|Standardized Baseline-Adjusted Trough Morning Forced Expiratory Volume in One Minute (FEV1) Area Under the Effect Curve From Time Zero to 6 Weeks (AUEC(0-6wk))|The primary efficacy variable was the standardized baseline-adjusted trough morning (pre-dose and pre-rescue bronchodilator) FEV1 AUEC(0-6wk). Pulmonary function measurements such as FEV1 were obtained electronically by spirometry at the randomization visit, each treatment visit (Weeks 2, 4 and 6) and any unscheduled visit (such as the early termination visit). The highest FEV1 value from 3 acceptable and 2 repeatable maneuvers (maximum of 8 attempts) was used. The least-square (LS) means, difference of LS means and its 95% confidence interval (CI), and p-value represent the results obtained from the analysis of covariance with covariate adjustment for baseline, sex, age, current asthma therapy, and treatment.|Baseline (Day 0 of Treatment Period), weeks 2, 4, 6|The modified intent-to-treat (mITT) analysis set included all patients in the ITT analysis set and included the available data for those patients until they discontinued study drug treatment at treatment visit week 6 or last available study visit.||milliliters||Standard Error|Least Squares Mean
857840|NCT02487771|Secondary|Adaptive Regulation Assessment|The Parent Rating Scales of the Behavior Assessment System for Children 2nd Edition measures different aspects of a child’s behaviors as reported by a parent. Externalizing Problems is a measure of Aggression and Hyperactivity. Internalizing Problems is a measure of Anxiety, Depression, and Somatization. The Behavioral Symptoms Index is a more global measure of behavior problems and combines Externalizing Problems with the measure of Depression from Internalizing Problems, and additional measures of Atypicality, Withdrawal, and Attention Problems. Adaptive Skills is a measure of Adaptability, Social Skills, Activities of Daily Living, Functional Communication, and at age 6 years Leadership. All scores are derived from the general, combined sex normative tables of T-Scores. For Adaptive Skills higher T-Scores reflect a more optimal outcome. For all other measures lower T-Scores reflect a more optimal outcome. All T-Scores were standardized with a Mean = 50, St Dev = 10.|72 Months|Missing data due to attrition, missed appointments, refusals.||T-scores||Standard Deviation|Mean
857841|NCT02487771|Secondary|Adaptive Regulation Assessment|The Parent Rating Scales of the Behavior Assessment System for Children 2nd Edition measures different aspects of a child’s behaviors as reported by a parent. Externalizing Problems is a measure of Aggression and Hyperactivity. Internalizing Problems is a measure of Anxiety, Depression, and Somatization. The Behavioral Symptoms Index is a more global measure of behavior problems and combines Externalizing Problems with the measure of Depression from Internalizing Problems, and additional measures of Atypicality, Withdrawal, and Attention Problems. Adaptive Skills is a measure of Adaptability, Social Skills, Activities of Daily Living, Functional Communication, and at age 6 years Leadership. All scores are derived from the general, combined sex normative tables of T-Scores. For Adaptive Skills higher T-Scores reflect a more optimal outcome. For all other measures lower T-Scores reflect a more optimal outcome. All T-Scores were standardized with a Mean = 50, St Dev = 10.|60 Months|Missing data due to attrition, missed appointments, refusals.||T-scores||Standard Deviation|Mean
857842|NCT02487771|Secondary|Adaptive Regulation Assessment|The Parent Rating Scales of the Behavior Assessment System for Children 2nd Edition measures different aspects of a child’s behaviors as reported by a parent. Externalizing Problems is a measure of Aggression and Hyperactivity. Internalizing Problems is a measure of Anxiety, Depression, and Somatization. The Behavioral Symptoms Index is a more global measure of behavior problems and combines Externalizing Problems with the measure of Depression from Internalizing Problems, and additional measures of Atypicality, Withdrawal, and Attention Problems. Adaptive Skills is a measure of Adaptability, Social Skills, Activities of Daily Living, Functional Communication, and at age 6 years Leadership. All scores are derived from the general, combined sex normative tables of T-Scores. For Adaptive Skills higher T-Scores reflect a more optimal outcome. For all other measures lower T-Scores reflect a more optimal outcome. All T-Scores were standardized with a Mean = 50, St Dev = 10.|48 Months|Missing data due to attrition, missed appointments, refusals.||T-scores||Standard Deviation|Mean
857843|NCT02487771|Secondary|Adaptive Regulation Assessment|The Parent Rating Scales of the Behavior Assessment System for Children 2nd Edition measures different aspects of a child’s behaviors as reported by a parent. Externalizing Problems is a measure of Aggression and Hyperactivity. Internalizing Problems is a measure of Anxiety, Depression, and Somatization. The Behavioral Symptoms Index is a more global measure of behavior problems and combines Externalizing Problems with the measure of Depression from Internalizing Problems, and additional measures of Atypicality, Withdrawal, and Attention Problems. Adaptive Skills is a measure of Adaptability, Social Skills, Activities of Daily Living, Functional Communication, and at age 6 years Leadership. All scores are derived from the general, combined sex normative tables of T-Scores. For Adaptive Skills higher T-Scores reflect a more optimal outcome. For all other measures lower T-Scores reflect a more optimal outcome. All T-Scores were standardized with a Mean = 50, St Dev = 10.|36 Months|Missing data due to attrition, missed appointments, refusals.||T-scores||Standard Deviation|Mean
858019|NCT01981057|Secondary|Carbohydrates|"Prescriptions for carbohydrates in parenteral nutrition solutions will be ordered individually and flipped with Numeta or vice versa. This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations"|6 weeks||||||
857844|NCT02487771|Primary|Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Verbal IQ|The Verbal IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child’s verbal ability based upon assessments of vocabulary, general knowledge, and reasoning. At three years the Verbal IQ score has a range of 49 (poorest performance) to 150 (best performance). For the older ages the score can range from 46 to 155. For all ages the assessment is normed to a Mean = 100, St Dev = 15.|72 Months|Missing data due to attrition, missed appointments, refusals, or questionable test||units on a scale||Standard Deviation|Mean
857845|NCT02487771|Primary|Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Verbal IQ|The Verbal IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child’s verbal ability based upon assessments of vocabulary, general knowledge, and reasoning. At three years the Verbal IQ score has a range of 49 (poorest performance) to 150 (best performance). For the older ages the score can range from 46 to 155. For all ages the assessment is normed to a Mean = 100, St Dev = 15.|48 Months|Missing data due to attrition, missed appointments, refusals, or questionable test||units on a scale||Standard Deviation|Mean
857846|NCT02487771|Primary|Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Verbal IQ|The Verbal IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child’s verbal ability based upon assessments of vocabulary, general knowledge, and reasoning. At three years the Verbal IQ score has a range of 49 (poorest performance) to 150 (best performance). For the older ages the score can range from 46 to 155. For all ages the assessment is normed to a Mean = 100, St Dev = 15.|36 Months|Missing data due to attrition, missed appointments, refusals, or questionable test||units on a scale||Standard Deviation|Mean
857847|NCT02487771|Primary|Cognitive Function Score - Test of Preschool Early Literacy|The Test of Preschool Early Literacy provides a standardized Early Literacy Index score, a measure of general, early literacy skills that relate to later reading and writing skill acquisition. The score is based on assessments of vocabulary, print knowledge, and phonological awareness. The score can range from 40 (poorest performance) to 144 (best performance) and has been normed to a Mean = 100, St Dev = 15.|42 Months|Missing data due to attrition, missed appointments, refusals, or questionable test.||units on a scale||Standard Deviation|Mean
857848|NCT02487771|Primary|Cognitive Function Score - Peabody Picture Vocabulary Test|The Peabody Picture Vocabulary Test, 3rd Edition provides a standardized assessment of a person’s receptive vocabulary. The Standard Score can range from 40 (poorest performance) to 160 (best performance) and has been normed to a Mean = 100, St Dev = 15.|60 Months|Missing data due to attrition, missed appointments, refusals, or questionable test.||units on a scale||Standard Deviation|Mean
857849|NCT02487771|Primary|Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ|The Full Scale IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child’s general intellectual ability based upon assessments of verbal, cognitive, and performance domains. At three years the Full Scale IQ score has a range of 41 (poorest performance) to 155 (best performance). For the older ages the score can range from 40 to 160. For all ages the assessment is normed to a Mean = 100, St Dev = 15.|72 Months|Missing data for participants dues to attrition, missed appointments, refusals, or questionable test.||units on a scale||Standard Deviation|Mean
857850|NCT02487771|Primary|Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ|The Full Scale IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child’s general intellectual ability based upon assessments of verbal, cognitive, and performance domains. At three years the Full Scale IQ score has a range of 41 (poorest performance) to 155 (best performance). For the older ages the score can range from 40 to 160. For all ages the assessment is normed to a Mean = 100, St Dev = 15.|48 Months|Missing data for participants dues to attrition, missed appointments, refusals, or questionable test.||units on a scale||Standard Deviation|Mean
857851|NCT02487771|Primary|Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ|The Full Scale IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child’s general intellectual ability based upon assessments of verbal, cognitive, and performance domains. At three years the Full Scale IQ score has a range of 41 (poorest performance) to 155 (best performance). For the older ages the score can range from 40 to 160. For all ages the assessment is normed to a Mean = 100, St Dev = 15.|36 Months|Missing data for participants dues to attrition, missed appointments, refusals, or questionable test.||units on a scale||Standard Deviation|Mean
857852|NCT02478580|Secondary|The Aldrete Score|Aldrete score used for readiness of PACU discharge by assigning numeric values to the criteria including activity, respiration, circulation, consciousness, and color. Each criterion is rated from 0 to 2, with a maximum score of 10. Scores in the range of 9 to 10 are considered satisfactory for PACU discharge.|2 hours after extubation|||units on a scale||Standard Error|Mean
857853|NCT02478580|Primary|Postoperative Care Unit (PACU) Recovery Time|Participants will be followed for the duration of PACU stay, an expected average of 3 hours.|Immediate postoperative period (up to 3 hours)|Patient with obstructive sleep apnea undergoing surgery||Minutes||Standard Deviation|Mean
857890|NCT02345772|Primary|Pathological Complete Remission Rate|To determine pathological complete remission rate at the time of surgery in ER-positive and HER2-positive breast cancer patients undergoing neoadjuvant chemoimmunotherapy (docetaxel, trastuzumab, pertuzumab) concurrently with neoadjuvant hormonal therapy with fulvestrant. Note: pCR, defined as the absence of invasive neoplastic cells of the primary tumor in the breast, remaining in-situ lesions are allowed, ypT0-is;|one year||||||
858020|NCT01981057|Secondary|Energy|"Prescriptions for energy in parenteral nutrition solutions will be ordered individually and flipped with Numeta or vice versa. This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations"|6 weeks||||||
857869|NCT02464163|Secondary|Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine|Unsolicited adverse events (UAEs) Days 0-42.|42 Days|Safety Population||Participants|||Count of Participants
857870|NCT02464163|Secondary|Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination||13 months|Safety Population||Participants|||Count of Participants
857871|NCT02464163|Secondary|Reactogenicity Immediately After Each Injection, Extending to Day 7|Solicited events of local and systemic reactogenicity Days 0-7|7 Days|Reactogenicity Population||Participants|||Count of Participants
857872|NCT02464163|Primary|Demonstrate That the Immunogenicity of Adjuvanted Panblok H7 rHA is Sufficient to Support Emergency Use Authorization in the Event of a Declared Pandemic.|The primary endpoint will be “seroprotection rate” to the selected dose of adjuvanted H7 rHA, defined by a post-vaccination HAI titer ≥40 on Day 42. The definition of success will be a lower bound of the two-sided 95% CI ≥ 70% for adults <65 and ≥60% for adults ≥65 years of age.|42 Days|Modified Per Protocol Population||Participants|||Count of Participants
857873|NCT02434146|Primary|Time to Onset of Grade 3 Oral Mucositis|Will be analyzed using a parametric (one-parameter exponential) cure rate model. Will be performed in both the extended cohort as well as in the historical controls.|Time between the first date of radiation or cyclophosphamide treatment to the date of the onset of grade 3 oral mucositis, assessed up to 3 months|This study was closed prematurely due to decreased numbers of eligible subjects. The full target accrual number was not achieved, and time to onset of grade 3 oral mucositis could not be analyzed.|||||
857874|NCT02434146|Primary|Time to Onset of Grade 2 Oral Mucositis|Will be analyzed using a parametric (one-parameter exponential) cure rate model. Will be performed in both the extended cohort as well as in the historical controls.|Time between the first date of radiation or cyclophosphamide treatment to the date of the onset of grade 2 oral mucositis, assessed up to 3 months|This study was closed prematurely due to decreased numbers of eligible subjects. The full target accrual number was not achieved, and time to onset of grade 2 oral mucositis could not be analyzed.|||||
857875|NCT02434146|Primary|Recommended Phase IIa Dose|The dose of topical phenylephrine solution which will be recommended for a larger follow-up phase II efficacy study will be established after the dose cohort at the MTD has been expanded to a total of 12 patients.|During the conditioning regimen (radiation and cyclophosphamide treatment), which is anticipated to last 1 week.|This study was closed prematurely due to decreased numbers of eligible subjects. The full target accrual number was not achieved, and the dose of topical phenylephrine solution for a larger follow-up phase II efficacy study could not be recommended.|||||
857876|NCT02434146|Primary|Maximum Tolerated Dose (MTD), Defined as the Highest Dose Level of Phenylephrine Applied to the Oral Mucosa Where 0/3, 0/6, or 1/6 Patients Experience a Dose-limiting Toxicity|Determine Maximum Tolerated Dose (MTD), the highest dose level of phenylephrine applied to the oral mucosa|During the conditioning regimen (radiation and cyclophosphamide treatment), which is anticipated to last 1 week.|This study was closed prematurely due to decreased numbers of eligible subjects. The full target accrual number was not achieved, and MTD could not be determined.|||||
857877|NCT02434146|Primary|Incidence of Adverse Events, Graded According to the Common Terminology Criteria for Adverse Events Version 4.0|Adverse events (AEs) will be presented in the summary tables by preferred term nested within the System Organ Class. Verbatim description, preferred term, and system organ class for all AEs will be contained in the patient data listings. All AEs occurring after enrollment and throughout the study period will be recorded. Each toxicity event will be assigned an attribution: unrelated, unlikely, possibly, probably, or definitely phenylephrine treatment related.|Up to 3 months|This study was closed prematurely due to decreased numbers of eligible subjects. The full target accrual number was not achieved, and no study conclusions could be made.|||||
857878|NCT02434146|Primary|Efficacy Response Rate for Preventing Oral Mucositis With Sufficient Accuracy|If a patient experiences no higher than grade 2 oral mucositis, then s/he will be defined as a responder. If a patient experiences grade >= 3 oral mucositis, s/he will be defined as a non-responder. Specifically, the efficacy response rate will be estimated with a standard error of less than 15% and the length of the 95% confidence interval will be less than 50%. The efficacy response rate will be summarized in tabular format. The Wilson score method will be used to calculate the 95% confidence interval for the efficacy response rate for the extended cohort.|Up to 3 months|This study was closed prematurely due to decreased numbers of eligible subjects. The full target accrual number was not achieved, and the efficacy response rate could not be estimated.|||||
857879|NCT02434146|Primary|Duration of Grade 3 Oral Mucositis|If the grade 3 oral mucositis has not been resolved (to a grade < 3) by the last day of toxicity assessment, then the duration will be censored at the last date of toxicity assessment. Will be analyzed using the Kaplan-Meier method. The median duration of grade 2/grade 3 oral mucositis will be calculated and reported along with the corresponding 95% confidence interval. This analysis will be performed in both the extended cohort as well as in the historical controls.|Date of onset of grade 3 oral mucositis to the date of resolution to grade < 3 oral mucositis, assessed up to 3 months|This study was closed prematurely due to decreased numbers of eligible subjects. The full target accrual number was not achieved, and the median duration of oral mucositis could not be analyzed.|||||
857880|NCT02434146|Primary|Duration of Grade 2 Oral Mucositis|If the grade 2 oral mucositis has not been resolved (to a grade < 2) by the last day of toxicity assessment, then the duration will be censored at the last date of toxicity assessment. Will be analyzed using the Kaplan-Meier method. The median duration of grade 2/grade 3 oral mucositis will be calculated and reported along with the corresponding 95% confidence interval. This analysis will be performed in both the extended cohort as well as in the historical controls.|Date of onset of grade 2 oral mucositis to the date of the resolution of the grade 2 oral mucositis, assessed up to 3 months|This study was closed prematurely due to decreased numbers of eligible subjects. The full target accrual number was not achieved, and the median duration of oral mucositis could not be analyzed.|||||
857881|NCT02434146|Primary|Area Under the Curve (AUC) for the Oral Mucositis Severity|The mucositis AUC will be estimated using the trapezoid method and summarized in terms of means, standard deviation, median and range. This analysis will be performed in both the extended cohort as well as in the historical controls.|Up to 3 months|This study was closed prematurely due to decreased numbers of eligible subjects. The full target accrual number was not achieved, and AUC could not be estimated or analyzed.|||||
857882|NCT02408692|Secondary|Maximum Serum Concentration Between Obese BMI Women Ingesting 1.5mg of Levonorgestrel and Then the Same Obese BMI Women Ingesting 3mg Levonorgestrel|Pharmacokinetic sampling at 0, 0.5, 1, 1.5, 2, and 2.5 hours were performed after ingestion of 3mg of levonorgestrel|Follicular phase of menstrual cycle|||ng/mL||Standard Deviation|Mean
857883|NCT02408692|Primary|Maximum Serum Concentration Between Normal and Obese BMI Women Ingesting 1.5mg Levonorgestrel|Pharmacokinetic sampling at 0, 0.5, 1, 1.5, 2, and 2.5 hours were performed after ingestion of 1.5mg of levonorgestrel|Follicular phase of menstrual cycle and PK sampling at 0, 0.5, 1, 1.5, 2, 2.5|||ng/mL||Standard Deviation|Mean
857884|NCT02395653|Secondary|Number Of Participants To Experience Clinically Relevant Respiratory Depression (CRRD)|Respiratory function and occurrence of CRRD was defined as simultaneous occurrence of bradypnoea (respiratory rate <10 breaths per minute for participants 9-15 years of age and sustained for 1 minute, or <8 breaths per minute for participants 16-17 years of age), with excessive sedation (that is, the participant is not easily aroused).|From the time of application of the first system through 7 days following end of study drug administration.|The Evaluable Population consists of all participants who received fentanyl from the SSEC for at least 3 hours.||participants|||Number
857885|NCT02395653|Secondary|Change From Baseline To 1 Hour And 24 Hours In Skin Irritation Score After SSEC Removal|Skin irritation at the SSEC application site was to be assessed immediately prior to placement of the study system and at 1 and 24 hours after removal of each study system. The application site was to be scored using the following scale: 0=No evidence of irritation; 1=Minimal erythema, barely perceptible; 2=Definite erythema, readily visible, minimal edema, or minimal papular response; 3=Erythema and papules; 4=Definite edema; 5=Erythema, edema, and papules; 6=Vesicular eruption; 7=Strong reaction spreading beyond the application site.|Baseline, 1 hour and 24 hours after SSEC removal.|The Evaluable Population consists of all participants who received fentanyl from the SSEC for at least 3 hours.||units on a scale||Standard Deviation|Mean
857886|NCT02395653|Primary|Assessment Of Adherence Of The SSEC System To Skin|The adhesion of each SSEC was evaluated immediately prior to removal at each 24-hour time point, or at early withdrawal. Adhesion was recorded using the following classification: System adhered to at least 90% of the application area with no edges unattached; System adhered between 75% and 89%; System was <75% adhered and not taped; System was secured with tape. The number of SSEC systems for all time points in each category is presented. Because of the descriptive nature of this study, no formal statistical hypothesis testing was performed.|Immediately prior to removal at each 24-hour time point, or at early withdrawal, for up to 3 consecutive days (up to 72 hours)|The Evaluable Population consists of all participants who received fentanyl from the SSEC for at least 3 hours.||SSEC systems|SSEC systems used by 61 participants||Number
857887|NCT02395653|Primary|Assessment Of Participant's Ability To Use The SSEC|Investigator's assessment of participant's ability to use the SSEC system safely and effectively. The assessment consisted of a 4-level categorical evaluation (poor, fair, good, and excellent). Because of the descriptive nature of this study, no formal statistical hypothesis testing was performed.|Completed at the time of the participant’s termination of study treatment (up to 72 hours after study drug administration)|The Evaluable Population consists of all participants who received fentanyl from the SSEC for at least 3 hours.||participants|||Number
857888|NCT02345772|Secondary|QTA (Quantitative Texture Analysis)|QTA (Quantitative Texture Analysis): will be obtained from baseline mammogram and the correlation with clinical outcome after neoadjuvant therapy will be performed.|One year||||||
857889|NCT02345772|Secondary|Partial Pathological Response Rate|Partial pathological response rate at the time of surgery and biomarker changes in breast cancer (biopsy vs residual tumor) before and after neoadjuvant chemotherapy Note: pPR, defined as residual invasive disease of 1cm, ypT1a-b.|One Year||||||
857925|NCT02241720|Primary|Disease Stability at Eight Weeks Post the End of Treatment Visit||5 months - 3 months treatment and 8 weeks post end of treatment visit|3 subjects did not complete an 8 week EOT visit for: Death, Patient W/D, AE.||Participants|||Count of Participants
857944|NCT02166476|Secondary|Pharmacokinetic (PK) Characterization Of Plasma Exposure Of Meropenem/Vaborbactam|This outcome measure focused on PK assessment of participants in the meropenem/vaborbactam group who met MITT criteria and had at least 1 plasma PK sample drawn. PK samples on Day 1 were taken 3-3.5 hours and 5-6 hours after the start of the first 3-h IV study drug infusion. Samples were not collected around the 30-minute infusions. Samples were collected from both groups to maintain the blind; however, only PK samples for the meropenem/vaborbactam group were analyzed. The area under the concentration-time curve during 24 hours (AUC0-24) for Day 1 and at steady-state are presented in micrograms (ug)·hour/mL.|Day 1|PK Population: Participants in the MITT Population (all participants screened, randomized, and received at least one dose of study drug) and had at least one plasma PK sample drawn. Due to renal impairment, 28 participants received a reduced dose of the study drug (1 g meropenem/1 g vaborbactam).||ug·hour/mL||Standard Deviation|Mean
857945|NCT02166476|Secondary|Per-Pathogen Microbiological Outcome (EMA) In The ME Population|This secondary outcome measure focused on the per-pathogen (E. cloacae, E. faecalis, E. coli, K. pneumoniae) microbiological outcome of Eradication in the ME population at 5 time points: Day 3, EOIVT, EOT, TOC, and LFU. Eradication was defined per the EMA criteria as a reduction in baseline bacterial pathogen(s) to <10^3 CFU/mL of urine culture and a negative blood culture for an organism that was identified as an uropathogen (if repeated after positive at baseline blood culture).|Day 3, EOIVT (Days 5-14), EOT (Days 10-14), TOC (Days 15-23), and LFU (Days 22-30)|ME Population||Participants|||Count of Participants
857946|NCT02166476|Secondary|Per-Pathogen Microbiological Outcome (EMA) In The m-MITT Population|This secondary outcome measure focused on the per-pathogen (E. cloacae, E. faecalis, E. coli, K. pneumoniae) microbiological outcome of Eradication in the m-MITT population at 5 time points: Day 3, EOIVT, EOT, TOC, and LFU. Eradication was defined per the EMA criteria as a reduction in baseline bacterial pathogen(s) to <10^3 CFU/mL of urine culture and a negative blood culture for an organism that was identified as an uropathogen (if repeated after positive at baseline blood culture).|Day 3, EOIVT (Days 5-14), EOT (Days 10-14), TOC (Days 15-23), and LFU (Days 22-30)|m-MITT Population||Participants|||Count of Participants
857947|NCT02166476|Secondary|Per-Pathogen Microbiological Outcome (FDA) In The ME Population|This secondary outcome measure focused on the per-pathogen (E. cloacae, E. faecalis, E. coli, K. pneumoniae) microbiological outcome of Eradication in the ME population at 5 time points: Day 3, EOIVT, EOT, TOC, and LFU. Eradication was defined per the FDA criteria as a reduction in baseline bacterial pathogen(s) to <10^4 CFU/mL of urine culture and a negative blood culture for an organism that was identified as an uropathogen (if repeated after positive at baseline blood culture).|Day 3, EOIVT (Days 5-14), EOT (Days 10-14), TOC (Days 15-23), and LFU (Days 22-30)|ME Population||Participants|||Count of Participants
857948|NCT02166476|Secondary|Per-Pathogen Microbiological Outcome (FDA) In The m-MITT Population|This secondary outcome measure focused on the per-pathogen (Enterobacter cloacae [E. cloacae], Enterococcus faecalis [E. faecalis], Escherichia coli [E. coli], Klebsiella pneumoniae [K. pneumoniae]) microbiological outcome of Eradication in the m-MITT population at 5 time points: Day 3, EOIVT, EOT, TOC, and LFU. Eradication was defined per the FDA criteria as a reduction in baseline bacterial pathogen(s) to <10^4 CFU/mL of urine culture and a negative blood culture for an organism that was identified as an uropathogen (if repeated after positive at baseline blood culture).|Day 3, EOIVT (Days 5-14), EOT (Days 10-14), TOC (Days 15-23), and LFU (Days 22-30)|m-MITT Population||Participants|||Count of Participants
857949|NCT02166476|Secondary|Proportion Of Participants With A Clinical Outcome Of Cure In The ME Population|This secondary outcome measure focused on a clinical outcome of Cure in the ME population. A clinical outcome of Cure was defined as the following: at EOIVT, the complete resolution or significant improvement of the baseline signs and symptoms of cUTI or AP; at EOT, TOC, and LFU, the complete resolution or significant improvement of the baseline signs and symptoms of cUTI or AP such that no further antimicrobial therapy was warranted. Symptom resolution did not necessarily include baseline symptoms associated with anatomic abnormalities that predisposed to cUTI, such as symptoms associated with the presence of an indwelling urinary catheter. The clinical outcome of Cure was reported only at the EOIVT, EOT, TOC, and LFU visits, and improvement was reported only at the Day 3, EOIVT, and EOT visits.|Day 3, EOIVT (Days 5-14), EOT (Days 10-14), TOC (Days 15-23), and LFU (Days 22-30)|ME Population||Participants|||Count of Participants
857950|NCT02166476|Secondary|Proportion Of Participants With A Clinical Outcome Of Cure In The Clinical Evaluable (CE) Population|This secondary outcome measure focused on a clinical outcome of Cure in the CE population. A clinical outcome of Cure was defined as the following: at EOIVT, the complete resolution or significant improvement of the baseline signs and symptoms of cUTI or AP; at EOT, TOC, and LFU, the complete resolution or significant improvement of the baseline signs and symptoms of cUTI or AP such that no further antimicrobial therapy was warranted. Symptom resolution did not necessarily include baseline symptoms associated with anatomic abnormalities that predisposed to cUTI, such as symptoms associated with the presence of an indwelling urinary catheter. The clinical outcome of Cure was reported only at the EOIVT, EOT, TOC, and LFU visits, and improvement was reported only at the Day 3, EOIVT, and EOT visits.|Day 3, EOIVT (Days 5-14), EOT (Days 10-14), TOC (Days 15-23), and LFU (Days 22-30)|CE Population||Participants|||Count of Participants
857951|NCT02166476|Secondary|Proportion Of Participants With A Clinical Outcome Of Cure In The m-MITT Population|This secondary outcome measure focused on a clinical outcome of Cure in the m-MITT Population. A clinical outcome of Cure was defined as the following: at EOIVT, the complete resolution or significant improvement of the baseline signs and symptoms of cUTI or AP; at EOT, TOC, and LFU, the complete resolution or significant improvement of the baseline signs and symptoms of cUTI or AP such that no further antimicrobial therapy was warranted. Symptom resolution did not necessarily include baseline symptoms associated with anatomic abnormalities that predisposed to cUTI, such as symptoms associated with the presence of an indwelling urinary catheter. The clinical outcome of Cure was reported only at the EOIVT, EOT, TOC, and LFU visits, and improvement was reported only at Day 3, EOIVT, and EOT visits.|Day 3, EOIVT (Days 5-14), EOT (Days 10-14), TOC (Days 15-23), and LFU (Days 22-30)|m-MITT Population||Participants|||Count of Participants
857952|NCT02166476|Secondary|Proportion Of Participants In The ME Population Who Achieved A Microbiologic Outcome Of Eradication|This secondary outcome measure focused on a microbiological outcome of Eradication in the ME population at 5 time points: Day 3, EOIVT, EOT, TOC, and LFU. Eradication was defined as a reduction in baseline bacterial pathogen(s) to <10^4 CFU/mL of urine culture (FDA) or <10^3 CFU/mL (EMA), and a negative blood culture for an organism that was identified as an uropathogen (if repeated after positive at baseline blood culture).|Day 3, EOIVT (Days 5-14), EOT (Days 10-14), TOC (Days 15-23), and LFU (Days 22-30)|ME Population||Participants|||Count of Participants
857953|NCT02166476|Secondary|Proportion Of Participants In The m-MITT Population Who Achieved A Microbiologic Outcome Of Eradication|This secondary outcome measure focused on a microbiological outcome of Eradication in the m-MITT population at 5 time points: Day 3, EOIVT, end of treatment (EOT), TOC, and late follow up (LFU). Eradication was defined as a reduction in baseline bacterial pathogen(s) to <10^4 CFU/mL of urine culture (FDA) or <10^3 CFU/mL (EMA), and a negative blood culture for an organism that was identified as a uropathogen (if repeated after positive at baseline blood culture).|Day 3, EOIVT (Days 5-14), EOT (Days 10-14), TOC (Days 15-23), and LFU (Days 22-30)|m-MITT Population||Participants|||Count of Participants
857954|NCT02166476|Secondary|Proportion Of Participants In The ME Population With Overall Success|This secondary outcome measure focused on the overall success in the ME population at the EOIVT and TOC visits. Overall success was defined as a clinical outcome of Cured or Improvement and a microbiologic outcome of Eradication. Cured was defined as the complete resolution or significant improvement of the baseline signs and symptoms of cUTI or AP. Improvement was defined as lessening, incomplete resolution, or no worsening of the baseline signs and symptoms of cUTI or AP, but continued IV therapy was warranted. Eradication was defined using the FDA's CFU/mL criteria that the bacterial pathogen(s) found at baseline was/were reduced to <10^4 CFU/mL of urine culture and a negative blood culture for an organism that was identified as an uropathogen (if repeated after positive at baseline blood culture).|EOIVT (Days 5-14) and TOC (Days 15-23)|ME Population||Participants|||Count of Participants
857955|NCT02166476|Secondary|Proportion Of Participants In The m-MITT Population With Overall Success|This secondary outcome measure focused on the overall success in the ME population at the EOIVT and TOC visits. Overall success at TOC was defined as a clinical outcome of Cured and a microbiologic outcome of Eradication. Overall success at EOIVT was defined as a clinical outcome of Cured or Improvement and a microbiologic outcome of Eradication. Cured was defined as the complete resolution or significant improvement of the baseline signs and symptoms of cUTI or AP. Improvement was defined as lessening, incomplete resolution, or no worsening of the baseline signs and symptoms of cUTI or AP, but continued IV therapy was warranted. Eradication was defined using the FDA's CFU/mL criteria that the bacterial pathogen(s) found at baseline was/were reduced to <10^4 CFU/mL of urine culture and a negative blood culture for an organism that was identified as an uropathogen (if repeated after positive at baseline blood culture).|EOIVT (Days 5-14) and TOC (Days 15-23)|m-MITT Population||Participants|||Count of Participants
857956|NCT02166476|Primary|Proportion Of Participants In The Microbiological Evaluable (ME) Population Who Achieved A Microbiologic Outcome Of Eradication At The TOC Visit|This was the primary outcome measure for the EMA. For this measure, a microbiologic outcome of Eradication was defined using the EMA’s CFU/mL criteria: bacterial pathogen(s) found at baseline was reduced to <10^3 CFU/mL of urine culture and a negative blood culture for an organism that was identified as an uropathogen (if repeated after positive at baseline blood culture). The ME population included all participants who met m-MITT criteria and had a clinical outcome and microbiologic outcome at EOIVT or earlier; received <80% or >120% of expected IV doses; missed no more than 1 IV dose in the first 48 h, missed no more than 2 consecutive IV doses; received no less than 6 doses for failure or no less than 9 doses for cure.|TOC (Days 15-23)|ME Population||Participants|||Count of Participants
857957|NCT02166476|Primary|Proportion Of Participants In The m-MITT Population Who Achieved A Microbiologic Outcome Of Eradication At The Test Of Cure Visit|This was the primary outcome measure for the European Medicines Agency (EMA). For this measure, a microbiologic outcome of Eradication was defined using the EMA’s CFU/mL criteria: bacterial pathogen(s) found at baseline was reduced to <10^3 CFU/mL of urine culture and a negative blood culture for an organism that was identified as an uropathogen (if repeated after positive at baseline blood culture).|Test of cure (TOC) (Days 15-23)|m-MITT Population||Participants|||Count of Participants
857958|NCT02166476|Primary|Proportion Of Participants In The Microbiological Modified Intent-To-Treat (m-MITT) Population Who Achieved Overall Success At The End Of Intravenous Treatment Visit|This was the primary outcome measure for the Food and Drug Administration (FDA). For this composite outcome measure, overall success was achieved with a clinical outcome of Cure or Improvement and microbiologic outcome of Eradication at the end of intravenous treatment (EOIVT). Cure was defined as the complete resolution or significant improvement of the baseline signs and symptoms. Improvement was defined as lessening, incomplete resolution, or no worsening of the baseline signs and symptoms. Eradication was defined using the FDA's CFU/mL criteria that the bacterial pathogen(s) found at baseline was/were reduced to <10^4 colony-forming units (CFU)/mL of urine culture and a negative blood culture for an organism that was identified as an uropathogen (if repeated after positive at baseline blood culture).|EOIVT (Days 5-14)|The m-MITT population included all participants who were randomized, received at least 1 dose of study drug, and had a baseline bacterial pathogen(s) of ≥10^5 CFU/mL of urine at baseline urine culture or the same bacterial pathogen present in concurrent blood and urine cultures.||Participants|||Count of Participants
857959|NCT02149264|Secondary|Pharmacokinetic Parameter - Minimum Concentration Observed (Cmin) for Total Testosterone and Dihydrotestosterone|A validated LC/MS/MS method was used to determine the levels of total testosterone and dihydrotestosterone.|Samples collected at pre-dose, 2, 4, 6, 8 & 24 hours post-dose on Days 14, 35 & 56, and at pre-dose, 2, 4, 6, 8, 10, 12, 18 & 24 hours post-dose on Day 90|FAS population was used and included subjects who had sufficient pharmacokinetic data to determine a Cave(0-24) on Days 14, 35, 56, or 90, or discontinued the study early due to medical or safety reasons. Of 155 subjects, one subject discontinued due to an adverse event after Day 14 visit and not included in the analysis.||ng/dL||Standard Deviation|Mean
857960|NCT02149264|Secondary|Pharmacokinetic Parameter - Maximum Concentration Observed (Cmax) for Total Testosterone and Dihydrotestosterone|A validated LC/MS/MS method was used to determine the levels of total testosterone and dihydrotestosterone.|Samples collected at pre-dose, 2, 4, 6, 8 & 24 hours post-dose on Days 14, 35 & 56, and at pre-dose, 2, 4, 6, 8, 10, 12, 18 & 24 hours post-dose on Day 90|FAS population was used and included subjects who had sufficient pharmacokinetic data to determine a Cave(0-24) on Days 14, 35, 56, or 90, or discontinued the study early due to medical or safety reasons. Of 155 subjects, one subject discontinued due to an adverse event after Day 14 visit and not included in the analysis.||ng/dL||Standard Deviation|Mean
857961|NCT02149264|Secondary|Pharmacokinetic Parameter - Time at Which the Maximum Concentration Occurs (Tmax) for Total Testosterone and Dihydrotestosterone|A validated LC/MS/MS method was used to determine the levels of total testosterone and dihydrotestosterone.|Samples collected at pre-dose, 2, 4, 6, 8 & 24 hours post-dose on Days 14, 35 & 56, and at pre-dose, 2, 4, 6, 8, 10, 12, 18 & 24 hours post-dose on Day 90|FAS population was used and included subjects who had sufficient pharmacokinetic data to determine a Cave(0-24) on Days 14, 35, 56, or 90, or discontinued the study early due to medical or safety reasons. Of 155 subjects, one subject discontinued due to adverse event after Day 14 visit and not included in the analysis.||hr||Full Range|Median
857962|NCT02149264|Secondary|Pharmacokinetic Parameter - Area Under the Concentration-time Curve (AUCτ) for Total Testosterone and Dihydrotestosterone|A validated LC/MS/MS method was used to determine the levels of total testosterone and dihydrotestosterone.|Samples collected at pre-dose, 2, 4, 6, 8 & 24 hours post-dose on Days 14, 35 & 56, and at pre-dose, 2, 4, 6, 8, 10, 12, 18 & 24 hours post-dose on Day 90|FAS population was used and included subjects who had sufficient pharmacokinetic data to determine a Cave(0-24) on Days 14, 35, 56, or 90, or discontinued the study early due to medical or safety reasons. Number of subjects was less than 155 in some group(s) as parameter could not be calculated due to missing concentrations for that time-point.||ng*hr/dL||Standard Deviation|Mean
857963|NCT02149264|Secondary|Pharmacokinetic Parameter - Average Concentration (Cave) for Total Testosterone and Dihydrotestosterone|A validated high pressure liquid chromatography with tandem mass spectrometry detection (LC/MS/MS) method was used to determine the levels of total testosterone and dihydrotestosterone.|Samples collected at pre-dose, 2, 4, 6, 8 & 24 hours post-dose on Days 14, 35 & 56, and at pre-dose, 2, 4, 6, 8, 10, 12, 18 & 24 hours post-dose on Day 90|FAS population was used and included subjects who had sufficient pharmacokinetic data to determine a Cave(0-24) on Days 14, 35, 56, or 90, or discontinued the study early due to medical or safety reasons. Number of subjects was less than 155 in some group(s) as parameter could not be calculated due to missing concentrations for that time-point.||ng/dL||Standard Deviation|Mean
857964|NCT02149264|Secondary|Change From Baseline in Short Form-12 Health Survey (SF-12) Score|"Data collected from the SF-12 questionnaire, based on the norm-based scores was used to assess improvement in the psychometrically-based physical component summary (PCS) and mental component summary (MCS). Both PCS and MCS contained four sub-domains:
PCS:
Physical Functioning (2 items, questions 2-3)
Role-Physical (2 items, questions 4-5)
Bodily Pain (1 item, question 8)
General Health (1 item, question 1)
MCS:
Vitality (1 item, question 10)
Social Functioning (1 item, question 12)
Role-Emotional (2 items, questions 6-7)
Mental Health (2 items, questions 9 and 11)
PCS and MCS composite scores are computed using the scores of the 12 questions and range from 0-100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. Positive change from baseline indicated improvement in physical and mental health."|At Days 35 and 90|FAS population was used and included subjects who had sufficient pharmacokinetic data to determine a Cave(0-24) on Days 14, 35, 56, or 90, or discontinued the study early due to medical or safety reasons.||units on a scale||Standard Deviation|Mean
857965|NCT02149264|Secondary|Change From Baseline in Multidimensional Assessment of Fatigue (MAF) Score|"The MAF contains four sub-domains:
Severity (2 items, questions 1-2) (Score range: 2-20)
Distress (1 item, question 3) (Score range: 1-10)
Degree of interference in activities of daily living (11 items, questions 4-14) (Score range: 11-110)
Timing (2 items, questions 15-16) (Score range: 5-20)
A score of 1-10 is awarded to each of the 14 questions across the 3 domains. The timing domain (categorical in nature) are scored from 1-4. The scores are converted to 1-10 scale by multiplying each score by 2.5. Lower score in each domain indicates improvement in fatigue.
To calculate GFI : Score of question 15 is converted to a 0-10 scale by multiplying each score by 2.5 and then sum questions 1, 2, 3, average of 4-14, and newly scored question 15. A score of zero is assigned to question 2-16, if patient select 'no fatigue' to question 1. Question 16 is not included in GFI calculation. The GFI ranged from 1 (no fatigue) to 50 (severe fatigue)."|At Days 35 and 90|FAS population was used and included subjects who had sufficient pharmacokinetic data to determine a Cave(0-24) on Days 14, 35, 56, or 90, or discontinued the study early due to medical or safety reasons.||units on a scale||Standard Deviation|Mean
857966|NCT02149264|Secondary|Change From Baseline in International Index of Erectile Function (IIEF) Score|"Data collected from the five domains of sexual functions were summarized by descriptive statistics. The domains were:
Erectile function (6 items, questions 1-5 and 15) (Score range:1-30)
Orgasmic function (2 items, questions 9-10) (Score range: 0-10)
Sexual desire (2 items, questions 11-12) (Score range: 2-10)
Intercourse satisfaction (3 items, questions 6-8) (Score range: 0-15)
Overall satisfaction (2 items, questions 13-14) (Score range: 2-10)
A score of 0-5 is awarded to questions 1 to 10 and a score of 1-5 is awarded to questions 11 to 15. Total score was calculated by summing up scores of each domain and ranged from 5 to 75. Low score indicates severe dysfunction and a high score indicates no dysfunction in sexual function."|At Days 35 and 90|FAS population was used and included subjects who had sufficient pharmacokinetic data to determine a Cave(0-24) on Days 14, 35, 56, or 90, or discontinued the study early due to medical or safety reasons.||units on a scale||Standard Deviation|Mean
857967|NCT02149264|Secondary|The Percentage of Subjects Whose Cave(0-24) Serum Total Testosterone Levels Are ≥300 and ≤1050 ng/dL|The data were presented using descriptive statistics. No statistical analysis was performed.|At 14, 35 and 56|FAS population was used and included subjects who had sufficient pharmacokinetic data to determine a Cave(0-24) on Days 14, 35, 56, or 90, or discontinued the study early due to medical or safety reasons.||percentage of subjects|||Number
857968|NCT02149264|Primary|The Percentage of Subjects Whose Average Concentration (Cave(0-24)) Serum Total Testosterone Levels Are ≥300 and ≤1050 ng/dL|The data were presented using descriptive statistics. The 95% confidence interval (CI) of the proportion (response) was estimated using the normal approximation to the binomial distribution. The study was considered to have met its efficacy criteria if the percentage was ≥ 75% and the lower bound of the 95% CI was ≥ 65%.|At Day 90|Full Analysis Set (FAS) population was used and included subjects who had sufficient pharmacokinetic data to determine a Cave(0-24) on Days 14, 35, 56, or 90, or discontinued the study early due to medical or safety reasons.||percentage of subjects||95% Confidence Interval|Number
858018|NCT01981057|Secondary|Fat|"Prescriptions for fat in parenteral nutrition solutions will be ordered individually and flipped with Numeta or vice versa. This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations"|6 weeks||||||
857991|NCT02076243|Secondary|Safety and Tolerability|number of participants with adverse events as a measure of safety and tolerability|up to 5 years|||Participants|||Count of Participants
857992|NCT02076243|Secondary|Treatment Response|correlation of response to first line treatment with Nab-Paclitaxel with SPARC expression, with target lesions measured at the longest diameter of each non-lymph node lesion and the short axis for target lymph nodes|at week 8 post treatment|study terminated, results not collected|||||
857993|NCT02076243|Secondary|Prevalence of SPARC Expression|prevalence of SPARC expression in advanced squamous cell cancer of the skin. The tumor specimen used to determine SPARC expression wll be obtained from a biopsy previously performed as standard of care (such as to establish the diagnosis).|at baseline|study terminated, results not collected|||||
857994|NCT02076243|Secondary|Median Progression Free Survival|every eight weeks will reassess efficacy by imaging and can continue treatment if no progression and expect will be up to an average 5 years|average 5 years|study terminated, results not collected|||||
857995|NCT02076243|Primary|Response Rate|the percentage of subjects who develop Complete Response (CR) or Partial Response (PR)|at week 8 post treatment|study terminated, results not collected|||||
858007|NCT02035553|Primary|Antipsychotic Efficacy|Change from Baseline to Day 43 in the Neuropsychiatric Inventory-Nursing Home Version (NPI-NH) psychosis score (Delusions [Domain A]+Hallucinations [Domain B]) in the Full Analysis Set (FAS). The NPI-NH is a questionnaire that quantifies behavioral changes in dementia in nursing home patients and evaluates 12 behavioral domains. For each of the 12 behavioral domains the Frequency (scale:1=occasionally to 4=very frequently) is multiplied by the Severity (scale:1=Mild to 3=Severe) to obtain a domain score (frequency x severity), The NPI-NH Psychosis Subscale consists of the two domains of Delusions and Hallucinations, calculated by adding the Individual domain scores, to yield a possible total score of 0 to 24. Lower scores correspond to less severity. A negative change score from baseline indicates improvement.|Day 43|All randomized subjects who received at least one dose of study treatment and have both a Baseline and at least one post-Baseline NPI-NH psychosis score evaluation.||Score on the NPI-NH scale||95% Confidence Interval|Least Squares Mean
858008|NCT02019472|Secondary|Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Week 24|The ACR 20 Response is defined as >= 20% improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=20% improvement in 3 of following 5 assessments: subject’s assessment of pain using VAS (0-10 mm, 0 mm=no pain and 10 mm=worst possible pain), subject’s global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, subject’s assessment of physical function measured by HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and serum CRP.|Week 24|Full analysis set was defined as all randomized participants who received at least 1 (partial or complete) dose of study agent.||Percentage of participants|||Number
858009|NCT02019472|Secondary|Percentage of Participants With Disease Activity Index Score 28 (DAS28) Using Erythrocyte Sedimentation Rate (ESR) Remission at Week 24|"The Disease Activity Index Score 28 using ESR [DAS28 (ESR)] is a derived score combining tender joints (28 joints), swollen joints (28 joints), ESR, and Patient’s Global Assessment of Disease Activity. The 28 joints evaluated for swelling and tenderness were shoulder, elbow, wrist, MCP1, MCP2, MCP3, MCP4, MCP5, PIP1, PIP2, PIP3, PIP4, PIP5 joints of the upper right and upper left extremities as well as the knee joints of the lower right and lower left extremities. The DAS28-ESR is expressed on a score range of 0-10, with the minimum score= 0 (best) to maximum score= 10 (worst). The DAS28 (ESR) remission is defined as a DAS28 (ESR) value of less than 2.6 at a visit."|Week 24|Full analysis set was defined as all randomized participants who received at least 1 (partial or complete) dose of study agent.||Percentage of participants|||Number
858010|NCT02019472|Primary|Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Week 24|The ACR 50 Response is defined as greater than or equal to (>=) 50 percent (%) improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >= 50% improvement in 3 of following 5 assessments: subject’s assessment of pain using Visual Analog Scale (VAS) (0-10 millimeter [mm], 0 mm=no pain and 10 mm=worst possible pain), subject’s global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS (the scale ranges from 0 to 10, [0=no arthritis activity to 10=extremely active arthritis]), participant’s assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI) (the scale ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and serum C-Reactive Protein (CRP).|Week 24|Full analysis set was defined as all randomized participants who received at least 1 (partial or complete) dose of study agent.||Percentage of participants|||Number
858011|NCT02019472|Primary|Change From Baseline in Disease Activity Index Score 28 (DAS28) Erythrocyte Sedimentation Rate (ESR) at Week 24|"The Disease Activity Index Score 28 using ESR [DAS28 (ESR)] is a derived score combining tender joints (28 joints), swollen joints (28 joints), ESR, and Patient’s Global Assessment of Disease Activity. The 28 joints evaluated for swelling and tenderness were shoulder, elbow, wrist, MCP1, MCP2, MCP3, MCP4, MCP5, PIP1, PIP2, PIP3, PIP4, PIP5 joints of the upper right and upper left extremities as well as the knee joints of the lower right and lower left extremities. The DAS28-ESR is expressed on a score range of 0-10, with the minimum score= 0 (best) to maximum score= 10 (worst)."|Baseline and Week 24|Full analysis set was defined as all randomized participants who received at least 1 (partial or complete) dose of study agent. Participants with missing DAS28 (ESR) at baseline were excluded from the analysis.||units on a scale||Standard Deviation|Mean
858012|NCT01981057|Secondary|Osmolarity|"Osmolarity in parenteral nutrition solutions will be calculated individually and flipped with Numeta or vice versa. This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations"|6 weeks||||||
858013|NCT01981057|Secondary|Phosphorous|"Prescriptions for phosphorous in parenteral nutrition solutions will be ordered individually and flipped with Numeta or vice versa. This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations"|6 weeks||||||
858014|NCT01981057|Secondary|Magnesium|"Prescriptions for magnesium in parenteral nutrition solutions will be ordered individually and flipped with Numeta or vice versa. This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations"|6 weeks||||||
858015|NCT01981057|Secondary|Calcium|"Prescriptions for calcium in parenteral nutrition solutions will be ordered individually and flipped with Numeta or vice versa. This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations"|6 weeks||||||
858016|NCT01981057|Secondary|Potassium|"Prescriptions for Potassium in parenteral nutrition solutions will be ordered individually and flipped with Numeta or vice versa. This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations"|6 weeks||||||
858017|NCT01981057|Secondary|Sodium|"Prescriptions for sodium in parenteral nutrition solutions will be ordered individually and flipped with Numeta or vice versa. This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations"|6 weeks||||||
858021|NCT01981057|Primary|Protein|"Prescriptions for protein in parenteral nutrition solutions will be ordered individually and flipped with Numeta or vice versa. This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations."|6 weeks|||g/kg/d||Full Range|Median
858022|NCT01972568|Primary|Percentage of Subjects With Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response at Week 24 Using Day 1 as Baseline|SRI response, a composite measure of reduced SLE disease activity, was defined as a reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) disease activity score of greater than or equal to (>=) 4 points; no significant worsening in Physician’s Global Assessment (PGA) score (<10 % increase, defined as <0.3 point increase for statistical analyses); no new British Isles Lupus Assessment Group (BILAG) A organ domain scores and <=1 (defined as no more than one) new BILAG B organ domain score.|Week 24|mITT analysis set included all randomized subjects who had received at least 1 dose of IMP.||percentage of subjects|||Number
858023|NCT01972568|Post-Hoc|High Disease Activity Subpopulation (SLEDAI-2K >=10 at Screening): Logistic Regression of Percentage of Subjects With SRI-6 Response at Week 24|SRI-6 response, a composite measure of reduced SLE disease activity, was defined as a reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) disease activity score of greater than or equal to (>=) 6 points; no significant worsening in Physician’s Global Assessment (PGA) score (<10 % increase, defined as <0.3 point increase for statistical analyses); no new British Isles Lupus Assessment Group (BILAG) A organ domain scores and <=1 (defined as no more than one) new BILAG B organ domain score. Logistic regression of number of subjects with SRI-6 response was analyzed by using Logistic regression model.|Week 24|mITT_HDA analysis set included mITT population with high disease activity (HDA) defined as screening SLE Disease Activity Index (SLEDAI) >=10.||percentage of subjects|||Number
858024|NCT01972568|Secondary|Change From Week 0 (Day 1) in SF-36 Components at Week 24|The 36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical and mental component summary scores. Total of 10 variables were analyzed (8 aspects, 2 component summary scores). The score for each of the 8 aspects and 2 component summary scores was scaled from 0 to 100, where 0 = lowest level of functioning and 100 = highest level of functioning.|Week 0 (Day 1) and Week 24|"mITT analysis set included all randomized subjects who had received at least 1 dose of IMP. Here Number Analyzed signifies those subjects who were evaluable for this outcome measure at specified categories."||units on a scale||Standard Deviation|Mean
858025|NCT01972568|Secondary|Percentage of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs|An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious AE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent are events between first dose of study drug and up to 48 weeks. TEAEs include both Serious TEAEs and non-serious TEAEs.|Baseline up to 24 weeks after last dose of study drug (assessed up to maximum of 48 weeks)|Safety analysis set included all randomized subjects who received at least 1 dose of IMP.||percentage of subjects|||Number
858026|NCT01972568|Secondary|Percentage of Subjects With British Isles Lupus Assessment Group (BILAG)-Based Combined Lupus Assessment (BICLA) Response at Week 24|The BICLA response is defined as BILAG-2004 improvement (all screening visit BILAG A improving to B/C/D, all screening visit BILAG B to C/D, and <=1 new BILAG B and no new BILAG A); no deterioration in SLEDAI total score; PGA increase by <10% (defined as <0.3 point increase for the statistical analyses) and no nonpermitted medication/treatment.|Week 24|mITT analysis set included all randomized subjects who had received at least 1 dose of IMP. Here “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure.||percentage of subjects|||Number
858027|NCT01972568|Secondary|Time From Randomization to First SRI Response During Treatment Period|SRI response, a composite measure of reduced SLE disease activity, was defined as a reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) disease activity score of greater than or equal to (>=) 4 points; no significant worsening in Physician’s Global Assessment (PGA) score (<10 % increase, defined as <0.3 point increase for statistical analyses); no new British Isles Lupus Assessment Group (BILAG) A organ domain scores and <=1 (defined as no more than one) new BILAG B organ domain score. Time to first SRI response during treatment period was presented.|Baseline up to 24 Weeks|mITT analysis set included all randomized subjects who had received at least 1 dose of IMP.||weeks||95% Confidence Interval|Median
858028|NCT01972568|Secondary|Change From Screening in Prednisolone-Equivalent Corticosteroid (CS) Daily Dose at Week 24|Change From screening visit to Week 24 of prednisolone-equivalent CS daily dose was presented.|Screening and Week 24|mITT analysis set included all randomized subjects who had received at least 1 dose of IMP.||mg per day||Standard Deviation|Mean
858029|NCT01972568|Secondary|Percentage of Subjects With Patient Global Impression of Change (PGIC) Categories at Week 24|The PGIC is self-rated scale that asks the subject to describe the change in activity limitations, symptoms, emotions, and overall Quality of life (QoL) related to the subject's painful condition on the following scale: 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse) and 7 (very much worse). Percentage of subjects in the PGIC categories of very much or much improved (1 or 2), minimally improved or no change or minimally worse (3 or 4 or 5) and much or very much worse (6 or 7) at Week 24 were presented.|Week 24|mITT analysis set included all randomized subjects who had received at least 1 dose of IMP.||percentage of subjects|||Number
858059|NCT01871805|Secondary|Maximum Observed Plasma Concentration (Cmax) After Single Dose of Alectinib: Phase I|Cmax was expressed in nanograms per milliliter (ng/mL).|Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 24, 32 and 48 hours post-dose on Cycle 1 Day -3|Pharmacokinetic (PK) Evaluable Population included all participants who received any dose of alectinib and who had at least one post-baseline PK sample available. Here, number of participants analyzed = participants available for the analysis for this outcome measure.||ng/mL||Standard Deviation|Mean
858030|NCT01972568|Secondary|Percentage of Subjects at Week 24 Whose Prednisone-Equivalent Corticosteroid (CS) Dose Reduced From Screening by >=25% and to a Dose of =<7.5mg/Day, and no British Isles Lupus Assessment Group (BILAG) A or 2B Flare in Disease Activity|BILAG A or 2B flare is defined by 1 new BILAG A organ domain score and/or 2 new BILAG B organ domain scores compared to the Screening Visit. The BILAG disease activity index evaluates systemic lupus erythematosus (SLE) activity in 8 organ systems, using a separate alphabetic score (A to E) assigned to each organ system defined as follows. BILAG A: Disease sufficiently active requiring disease-modifying treatment (prednisone >20 mg daily or immunosuppressants); BILAG B: moderate disease activity requiring treatment with systemic low-dose oral glucocorticoids, intramuscular or intra-articular or soft tissue CS injection, topical CS or immunosuppressants, or symptomatic therapy such as antimalarials or NSAIDs. BILAG C: mild disease; BILAG D: system previously affected but now inactive and BILAG E: system never involved.|Week 24|mITT analysis set included all randomized subjects who had received at least 1 dose of IMP. Here “Number of Participants Analyzed” signifies those subjects whose CS dose >=10 mg at Screening.||percentage of subjects|||Number
858031|NCT01972568|Primary|Percentage of Subjects With Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response at Week 24 Using Screening Visit as Baseline|SRI response, a composite measure of reduced SLE disease activity, was defined as a reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) disease activity score of greater than or equal to (>=) 4 points; no significant worsening in Physician’s Global Assessment (PGA) score (<10 % increase, defined as <0.3 point increase for statistical analyses); no new British Isles Lupus Assessment Group (BILAG) A organ domain scores and <=1 (defined as no more than one) new BILAG B organ domain score.|Week 24|mITT analysis set included all randomized subjects who had received at least 1 dose of IMP.||percentage of subjects|||Number
858032|NCT01944098|Primary|Postoperative Pain|Analysis of patient outcome will involve a series of visual analogue scale pain evaluations during mobilization, coughing, and resting. VAS, 0 cm as no pain - 10 cm as maximum pain|24 hours post-surgery|||units on a scale||Full Range|Median
858033|NCT01944098|Primary|Postoperative Pain|Analysis of patient outcome will involve a series of visual analogue scale (VAS, 0 cm as no pain – 10 cm as maximum pain) pain evaluations during mobilization, coughing, and resting|18 hours post-surgery|||units on a scale||Full Range|Median
858034|NCT01944098|Primary|Postoperative Pain|Analysis of patient outcome will involve a series of visual analogue scale (VAS, 0 cm as no pain – 10 cm as maximum pain) pain evaluations during mobilization, coughing, and resting|12 hours post-surgery|||units on a scale||Full Range|Median
858035|NCT01944098|Primary|Postoperative Pain|Analysis of patient outcome will involve a series of visual analogue scale pain evaluations during mobilization, coughing, and resting. VAS, 0 cm as no pain - 10 cm as maximum pain|6 hours post-surgery|||units on a scale||Full Range|Median
858039|NCT01936974|Primary|Progression-free Survival|Evaluate progression-free survival between the two regimens.|One Year|Data were not collected|||||
858148|NCT01665599|Secondary|Pharmacokinetics of Total Testosterone Measuring Maximum Concentration Observed (Cmax)|A validated LC/MS/MS method was used to determine the levels of total testosterone.|Day 1; Day 90|ITT population was used which comprised of all participants who received at least one dose of IMP.||ng/dL||Standard Deviation|Mean
858060|NCT01871805|Secondary|Percentage of Participants With CNS Progression According to RANO by IRC: Phase II|CNS disease progression was defined as a new CNS lesion or progression of pre-existing CNS lesions according to RANO criteria . As per RANO criteria, progression was defined as 25% or more increase in SPD of measurable enhancing (measurable) compared to the best response after initiation of therapy or Screening; increase (significant) in non-enhancing T2/FLAIR lesions, not attributable to other non-tumor causes; any new lesions; and clinical deterioration (not attributable to other non-tumor causes and not due to steroid decrease).|Every 6 weeks from Cycle 1 Day 1 at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to Week 60; data cutoff date of 24 October 2014)|Safety Population in Phase II.||percentage of participants|||Number
858052|NCT01877564|Primary|IHC-based Tissue Markers of Proliferation||1 year|data were not collected|||||
858053|NCT01871805|Secondary|Change From Baseline in EORTC QLQ-LC13: Phase II|EORTC QLQ-LC13: consisted of 13 questions with one symptom scale for dyspnea of 3 items and 10 single items (cough, haemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm/shoulder, other pain, pain medication). Questions used 4-point scale (1 'Not at all' to 4 'Very much'. Scores were averaged and transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms.|Baseline, Weeks 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 42, 48, last visit (Week 60; data cutoff date of 24 October 2014)|Safety Population. Here, number of participants analyzed = participants available for the analysis for this outcome measure. Here, n = number of participants available for the analysis at specified timeframe for this outcome measure.||units on a scale||Standard Deviation|Mean
858054|NCT01871805|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4-point scale (1 ‘Not at all’ to 4 ‘Very much’; 2 questions used 7-point scale [1 ‘very poor’ to 7 ‘Excellent’]). Scores were averaged and transformed to lie between 0-100 scale; for each of the symptom scales, higher score=better level of functioning or greater degree of symptoms and lower score indicates lower level of that particular symptom.|Baseline, Weeks 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 42, 48, last visit (Week 60; data cutoff date of 24 October 2014)|Safety Population. Here, number of participants analyzed = participants available for the analysis for this outcome measure. Here, n = number of participants available for the analysis at specified timeframe for this outcome measure.||units on a scale||Standard Deviation|Mean
858055|NCT01871805|Secondary|Ctrough After Multiple Dose of Alectinib: Phase II||Pre-dose (0 hour) on Day 1 of Cycles 2, Cycle 3, Cycle 4, Cycle 5|PK Evaluable Population. Here, number of participants analyzed = participants available for the analysis for this outcome measure. Here, n = number of participants available for the analysis at specified timeframe in specified group.||ng/mL||Standard Deviation|Mean
858056|NCT01871805|Secondary|AUC From Time Zero to Last Measurable Concentration (AUClast) After Multiple Dose of Alectinib: Phase I||Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 8 and 10 hours post-dose on Cycle 2 Day 1|PK Evaluable Population. Here, number of participants analyzed = participants available for the analysis for this outcome measure.||hour*ng/mL||Standard Deviation|Mean
858057|NCT01871805|Secondary|Area Under the Plasma Concentration (AUC) Versus Time Curve Extrapolated to Infinity (AUCinf) After Single Dose of Alectinib: Phase I|AUCinf = AUC from time zero (pre-dose) to extrapolated infinite time. It is obtained from AUC (0- t) plus AUC (t-inf). AUC is expressed in hour*ng/mL.|Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 24, 32 and 48 hours post-dose on Cycle 1 Day -3|PK Evaluable Population. Here, number of participants analyzed = participants available for the analysis for this outcome measure.||hour*ng/mL||Standard Deviation|Mean
858058|NCT01871805|Secondary|Cmax After Multiple Dose of Alectinib: Phase I||Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 8 and 10 hours post-dose on Cycle 2 Day 1|PK Evaluable Population. Here, number of participants analyzed = participants available for the analysis for this outcome measure.||ng/mL||Standard Deviation|Mean
858061|NCT01871805|Secondary|Percentage of Participants With CNS Progression According to RECIST v1.1 by IRC: Phase II|CNS disease progression was defined as a new CNS lesion or progression of pre-existing CNS lesions according to RECIST 1.1. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.|Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to Week 60; data cut-off date 24 October 2014)|Safety Population in Phase II.||percentage of participants|||Number
858062|NCT01871805|Secondary|CDOR According to RANO by IRC: Phase II|CDOR was defined as the time from the first observation of a CNS response of CR or PR according to RANO criteria until first observation of CNS progression or death from any cause. An analysis by RANO criteria was performed. Definitions of CR or PR as per RANO was included in description of Outcome Measure 15. As per RANO criteria, progression was defined as 25% or more increase in SPD of measurable enhancing (measurable) compared to the best response after initiation of therapy or Screening; increase (significant) in non-enhancing T2/FLAIR lesions, not attributable to other non-tumor causes; any new lesions; and clinical deterioration (not attributable to other non-tumor causes and not due to steroid decrease) and clear worsening of neurological status with respect to the previous timepoint. DOR curves and the median time to the event was estimated using the methodology of Kaplan and Meier and 95% CI for median was computed using the method of Brookmeyer and Crowley.|Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to Week 60; data cut-off date 24 October 2014)||09/2017||||
858063|NCT01871805|Secondary|CNS Duration of Response (CDOR) According to RECIST v1.1 by IRC: Phase II|CDOR was defined for CNS responders as the time from the first observation of a CNS response of CR or PR until first observation of CNS progression or death from any cause. An analysis by IRC using RECIST v1.1 was performed. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. Refer “Outcome Measure 2” for the definition of CR and PR. DOR curves and the median time to the event was estimated using the methodology of Kaplan and Meier and 95% CI for median was computed using the method of Brookmeyer and Crowley.|Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to Week 60; data cut-off date 24 October 2014)||09/2017||||
858064|NCT01871805|Secondary|Percentage of Participants With COOR According to Response Assessment in Neuro-Oncology (RANO) by IRC: Phase II|CORR was defined as the proportion of participants who had a CR or PR according to RANO criteria of the baseline CNS lesions. As per RANO criteria, CR was defined as disappearance of all enhancing measurable and non-measurable disease, and no new lesions along with stable or clinically improved status, participants off corticosteroids (or on physiologic replacement doses only) and stable or improved non enhancing T2/FLAIR lesions; PR was defined as 50% or more decrease in sum of the products of the diameters (SPD) of measurable enhancing measurable lesions, no new lesion along with stable or clinically improved status, participants off corticosteroids (or on physiologic replacement doses only) and no progression of non-measurable disease (enhancing and non-enhancing T2/FLAIR lesions. Clopper and Pearson method was used to calculate 95% CI.|Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to Week 60; data cut-off date 24 October 2014)|Safety population. Here number of participants analyzed = participants with measurable CNS lesions at baseline based on RANO according to IRC.||percentage of participants||95% Confidence Interval|Number
858065|NCT01871805|Secondary|Percentage of Participants With Central Nervous System Objective Response Rate (CORR) Among Participants With Measurable Central Nervous System Lesions at Baseline According to RECIST v1.1 by IRC: Phase II|CORR was defined as the proportion of participants who had a CR or PR of the baseline CNS lesions, based on RECIST v.1.1. CNS responses according to RECIST v1.1 did not have to be confirmed. Refer “Outcome Measure 2” for the definition of CR and PR. 95% CI for median was computed using the method of Brookmeyer and Crowley.|Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to Week 60; data cut-off date 24 October 2014)|Safety population. Number of participants analyzed = participants with measurable CNS lesions at baseline based on RECIST according to IRC.||percentage of participants||95% Confidence Interval|Number
858066|NCT01871805|Secondary|DOR Assessed by Investigator: Phase II|DOR was defined for responders (CR or PR) as the time from when response was first documented, to first documented disease progression according to RECIST 1.1 or death (whichever occurred first). Participants who did not progress or did not die after they had a confirmed response were censored at the date of their last tumor measurement. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. Refer “Outcome Measure 2” for the definition of CR and PR. DOR curves and the median time to the event was estimated using the methodology of Kaplan and Meier and 95% CI for median was computed using the method of Brookmeyer and Crowley.|Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to Week 60; data cut-off date 24 October 2014)|Investigator RE Population who had best overall response of CR or PR were included for analysis.||months||95% Confidence Interval|Median
858067|NCT01871805|Secondary|DOR Assessed by IRC: Phase II|DOR was defined for responders (CR or PR) as the time from when response was first documented, to first documented disease progression according to RECIST 1.1 or death (whichever occurred first). Participants who did not progress or did not die after they had a confirmed response were censored at the date of their last tumor measurement. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. Refer “Outcome Measure 2” for the definition of CR and PR. DOR curves and the median time to the event was estimated using the methodology of Kaplan and Meier and 95% CI for median was computed using the method of Brookmeyer and Crowley.|Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to Week 60; data cut-off date 24 October 2014)|IRC RE Population who had best overall response of CR or PR were included for analysis.||months||95% Confidence Interval|Median
858139|NCT01665599|Secondary|Pharmacokinetics of DHT Measuring Tmin|A validated LC/MS/MS method was used to determine the levels of DHT.|Day 1; Day 90|ITT population was used which comprised of all participants who received at least one dose of IMP.||hour||Full Range|Median
858068|NCT01871805|Secondary|Overall Survival (OS) Time: Phase II|OS was defined as the time between date of first dose and date of death due to any cause. Participants without an event were censored at the date last known to be alive. Participants without any follow up information were censored at the date of first dose. OS curves and the median time to the event was estimated using the methodology of Kaplan and Meier and 95% CI for median was computed using the method of Brookmeyer and Crowley.|Baseline up to death (any cause) (data cutoff 24 October 2014, maximum follow up 60 weeks)|Safety Population||months||95% Confidence Interval|Median
858069|NCT01871805|Secondary|PFS by Investigator: Phase II|PFS was defined as the time between first dose of alectinib and date of first documented disease progression according to RECIST 1.1 or death, whichever occurred first. Participants who have neither progressed nor died at the time of the last clinical cut-off or who lost to follow-up were censored at the date of the last tumor assessment showing no progression of disease either during the study treatment or during follow-up. Participants with no post-baseline assessments were censored at the date of first dose. Progression of disease is defined as at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. PFS curves and the median time to the event was estimated using the methodology of Kaplan and Meier and 95% CI for median was computed using the method of Brookmeyer and Crowley.|Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to Week 60; data cut-off date 24 October 2014)|RE Population||months||95% Confidence Interval|Median
858070|NCT01871805|Secondary|Percentage of Participants With Disease Progression or Death by IRC: Phase II|Participants who have neither progressed according to RECIST 1.1 nor died at the time of the last clinical cut-off or who lost to follow-up were censored at the date of the last tumor assessment showing no progression of disease either during the study treatment or during follow-up. Participants with no post-baseline assessments were censored at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.|Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to Week 60; data cut-off date 24 October 2014)|Safety Population||percentage of participants|||Number
858071|NCT01871805|Secondary|Progression-Free Survival (PFS) by IRC: Phase II|PFS was defined as the time between first dose of alectinib and date of first documented disease progression according to RECIST 1.1 or death, whichever occurred first. Participants who have neither progressed nor died at the time of the last clinical cut-off or who lost to follow-up were censored at the date of the last tumor assessment showing no progression of disease either during the study treatment or during follow-up. Participants with no post-baseline assessments were censored at the date of first dose. Progression of disease is defined as at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. PFS curves and the median time to the event was estimated using the methodology of Kaplan and Meier and 95% CI for median was computed using the method of Brookmeyer and Crowley.|Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to Week 60; data cut-off date 24 October 2014)|Safety Population||months||95% Confidence Interval|Median
858072|NCT01871805|Secondary|Percentage of Participants With Disease Control by Investigator: Phase II|Disease control rate assessed according to RECIST 1.1 was defined as the percentage of participants with a best overall response of CR, PR, or stable disease (SD) lasting for at least 12 weeks, after the first dose of alectinib. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum of diameters on study. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. Refer “Outcome Measure 2” for the definition of CR and PR. 95% CI for rates were constructed using Clopper-Pearson method.|Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to Week 60; data cut-off date 24 October 2014)|RE Population comprised all participants with measurable disease at baseline according to the investigator who had a baseline tumor assessment and received at least one dose of alectinib.||percentage of participants||95% Confidence Interval|Number
858073|NCT01871805|Secondary|Percentage of Participants With Objective Response According to RECIST v1.1 by Investigator: Phase II|The objective response rate was defined as the proportion of responders in the response evaluable population, where responders were defined as participants determined to have a best overall response of CR or PR based on the RECIST 1.1 criteria. Refer “Outcome Measure 2” for the definition of CR and PR. CR and PR were to be confirmed by repeat assessments ≥4 weeks after initial documentation. Clopper-Pearson method was used to calculate 95% CI.|Every 6 weeks from Cycle 1 Day 1 at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to Week 60; data cut-off date 24 October 2014)|RE Population comprised all participants with measurable disease at baseline according to the investigator who had a baseline tumor assessment and received at least one dose of alectinib.||percentage of participants||95% Confidence Interval|Number
858074|NCT01871805|Secondary|Duration of Response (DOR) Assessed by Investigator: Phase I|DOR was defined for responders (CR or PR) as the time from when response was first documented, to first documented disease progression (according to RECIST 1.1) or death (whichever occurred first). Participants who did not progress or did not die after they had a CR were censored at date of their last tumor measurement. Progressive disease (PD): at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. Refer “Outcome Measure 2” for the definition of CR and PR. DOR curves and the median time to the event was estimated using the methodology of Kaplan and Meier and Brookmeyer and Crowley method was used to calculate 95% CI.|Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to Week 105; data cut-off date 24 October 2014)||09/2017||||
858140|NCT01665599|Secondary|Pharmacokinetics of DHT Measuring Cmin|A validated LC/MS/MS method was used to determine the levels of DHT.|Day 1; Day 90|ITT population was used which comprised of all participants who received at least one dose of IMP.||ng/dL||Standard Deviation|Mean
858075|NCT01871805|Secondary|Percentage of Participants With Objective Response According to RECIST v1.1 by Investigator: Phase I|The objective response rate was defined as the proportion of responders in the response evaluable population, where responders were defined as participants determined to have a best overall response of CR or PR based on the RECIST v1.1 criteria. Refer “Outcome Measure 2” for the definition of CR and PR. Clopper-Pearson method was used to calculate 95% CI.|Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to Week 105; data cut-off date 24 October 2014)|RE Population comprised all participants with measurable disease at baseline according to the investigator who had a baseline tumor assessment and received at least one dose of alectinib.||percentage of participants||95% Confidence Interval|Number
858076|NCT01871805|Primary|Percentage of Participants With Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) by Independent Review Committee (IRC): Phase II|The objective response rate assessed by IRC was defined as the proportion of responders in the response evaluable population, where responders were defined as participants determined to have a best overall response of complete response (CR) or partial response (PR) based on the RECIST 1.1 criteria. CR: disappearance of all target and non-target lesions (TLs) and normalization of tumor markers. Pathological lymph nodes must have short axis measures less than (<) 10 millimeter (mm). PR: at least a 30 percent (%) decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of TLs, taking as reference the baseline sum of diameters. CR and PR were to be confirmed by repeat assessments ≥4 weeks after initial documentation. Clopper-Pearson method was used to calculate 95% confidence interval (CI).|Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to Week 60; data cut-off date 24 October 2014)|Response Evaluable (RE) Population comprised all participants with measurable disease at baseline according to the IRC who had a baseline tumor assessment and received at least one dose of alectinib.||percentage of participants||95% Confidence Interval|Number
858077|NCT01871805|Primary|Number of Participants With Dose Limiting Toxicities (DLTs) - Phase I|The DLTs were defined as any which included Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding or Grade 4 neutropenia continuing for greater than equal to (>=) 7 consecutive days, non-hematological toxicity of Grade 3 or higher (excluding transient electrolyte abnormalities, diarrhea, nausea, and vomiting that recovers to Grade 2 or lower with appropriate treatment and participants having Grade 2 aspartate transaminase (AST) and/or alanine transaminase (ALT) at baseline must have Grade 3 AST/ALT for 7 days or Grade 4 AST/ALT to be considered a DLT), and adverse events (AEs) that required suspension of treatment for a total of >=7 days which the Investigator could not rule out as been related to alectinib.|Cycle 1 of Phase I (21 days)|Safety Population||participants|||Number
858080|NCT01860040|Primary|Rate of Pathologic Complete Responses (pCR) at the Time of Definitive Surgical Resection of Non-small Cell Lung Cancer|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by Magnetic Resonance Imagery (MRI): Complete Response (CR), Disappearance of all target lesions|One year||||||
858081|NCT01744483|Primary|Percentage of Patients With Tracheal Bacterial Colonization|The percentage of patients with quantitative culture growth from tracheal aspirate specimens of >1,000,000 CFU between Day 2 and Day 4 of tracheal intubation/mechanical ventilation. Percentage of patients will be compared between the three study arms.|Tracheal colonization by Day 4 or extubation|||percentage of tracheal colonization|||Number
858082|NCT01741259|Secondary|American Pain Society Patient Outcome Questionnaire #9|On a 0-10 scale, how satisfied are you with the results of your pain treatment with 0 being extremely dissatisfied and 10 being extremely satisfied. 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.|Survey day epidural stopped|||units on a scale||Standard Error|Mean
858083|NCT01741259|Secondary|American Pain Society Patient Outcome Questionnaire #8|On a 0-10 scale, were you allowed to participate in decisions about your pain treatment as much as you wanted to with 0 being not at all and 10 being entirely. 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.|Survey day epidural stopped|||units on a scale||Standard Error|Mean
858084|NCT01741259|Secondary|American Pain Society Patient Outcome Questionnaire #7|Select the percentage (from 0%-100%) of pain relief you received from all medical and non-medical treatments in the first 24 hours. 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.|Survey day epidural stopped|||percentage of pain relieved||Standard Error|Mean
858141|NCT01665599|Secondary|Pharmacokinetics of DHT Measuring Cave|A validated LC/MS/MS method was used to determine the levels of DHT.|Day 1; Day 90|ITT population was used which comprised of all participants who received at least one dose of IMP.||ng/dL||Standard Deviation|Mean
858085|NCT01741259|Secondary|American Pain Society Patient Outcome Questionnaire #6d|On a 0-10 scale, how severe was your dizziness where 0 is not at all and 10 is extremely. 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.|Survey day epidural stopped|||units on a scale||Standard Error|Mean
858086|NCT01741259|Secondary|American Pain Society Patient Outcome Questionnaire #6c|On a 0-10 scale, how severe was your itching where 0 is none and 10 is severe. 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.|Survey day epidural stopped|||units on a scale||Standard Error|Mean
858087|NCT01741259|Secondary|American Pain Society Patient Outcome Questionnaire #6b|On a 0-10 scale, how severe was your drowsiness where 0 is none and 10 is severe. 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.|Survey day epidural stopped|||units on a scale||Standard Error|Mean
858088|NCT01741259|Secondary|American Pain Society Patient Outcome Questionnaire #6a|On a scale of 0-10, what was the severity of your nausea where 0 is none and 10 is severe. 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.|Survey day epidural stopped|||units on a scale||Standard Error|Mean
858089|NCT01741259|Secondary|American Pain Society Patient Outcome Questionnaire #5d|How much, on a scale of 0-10, did the pain cause you to feel helpless where 0 is not at all and 10 is extremely. 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.|Survey day epidural stopped|||units on a scale||Standard Error|Mean
858090|NCT01741259|Secondary|American Pain Society Patient Outcome Questionnaire #5c|How much, on a scale of 0-10, did the pain cause you to feel frightened where 0 is not at all and 10 is extremely. 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.|Survey day epidural stopped|||units on a scale||Standard Error|Mean
858091|NCT01741259|Secondary|American Pain Society Patient Outcome Questionnaire #5b|On a scale of 0-10, how much did pain cause you to feel depressed where 0 is not al all and 10 is extremely. 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.|Survey day epidural stopped|||units on a scale||Standard Error|Mean
858092|NCT01741259|Secondary|American Pain Society Patient Outcome Questionnaire #5a|On a scale of 0-10, how much did the pain cause you to feel anxious where 0 is not at all anxious and 10 is extremely anxious. 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.|Survey day epidural stopped|||units on a scale||Standard Error|Mean
858093|NCT01741259|Secondary|American Pain Society Patient Outcome Questionnaire #4d|How much, on a scale of 0-10, did pain interfere with staying asleep where 0 is does not interfere and 10 is completely interferes. 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.|Survey day epidural stopped|||units on a scale||Standard Error|Mean
858094|NCT01741259|Secondary|American Pain Society Patient Outcome Questionnaire #4c|How much, on a 0-10 scale, did pain interfere with falling asleep where 0 is does not interfere and 10 is completely interferes. 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.|Survey day epidural stopped|||units on a scale||Standard Error|Mean
858095|NCT01741259|Secondary|American Pain Society Patient Outcome Questionnaire #4b|How much, on a 0-10 scale, did pain interfere with doing activities out of bed (walking, sitting in chair, standing at sink) where 0 is does not interfere and 10 is completely interferes. 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.|Survey day epidural stopped|||units on a scale||Standard Error|Mean
858096|NCT01741259|Secondary|American Pain Society Patient Outcome Questionnaire #4a|How much, on 0-10 scale, did pain interfere with doing activities in bed (turning, sitting up, repositioning) where 0 is does not interfere and 10 is completely interferes. 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.|Survey day epidural stopped|||units on a scale||Standard Error|Mean
858142|NCT01665599|Secondary|Pharmacokinetics of DHT Measuring Cmax|A validated LC/MS/MS method was used to determine the levels of DHT.|Day 1; Day 90|ITT population was used which comprised of all participants who received at least one dose of IMP.||ng/dL||Standard Deviation|Mean
858097|NCT01741259|Secondary|American Pain Society Patient Outcome Questionnaire #3|How often were you in severe pain in the first 24 hours (percentage 0-100%). 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.|Survey day epidural stopped|||percentage of time||Standard Error|Mean
858098|NCT01741259|Secondary|American Pain Society Patient Outcome Questionnaire #2|On 0-10 scale, indicate the worst pain you had in first 24 hours. 0 represents no pain and 10 represents the worst pain possible. 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.|Survey day epidural stopped|||units on a scale||Standard Error|Mean
858099|NCT01741259|Secondary|American Pain Society Patient Outcome Questionnaire #1|Please indicate on 0-10 scale the least pain you had in first 24 hours. 0 represents no pain and 10 represents the worst pain possible. 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.|Survey day epidural stopped|||units on a scale||Standard Error|Mean
858100|NCT01741259|Secondary|Total Drug Dose|Pharmacy will generate a report of the drug total from the pump on return to pharmacy.|48 hours post-op or when the epidural is stopped|||milligrams of drug per hour||Standard Deviation|Mean
858101|NCT01741259|Secondary|Adverse Outcomes|Adverse outcomes such as seizures or respiratory depression will be reported to anesthesia personnel by nursing if they occur. Patients are monitored for respiratory rate and sedation every 1 hour for 24 hours, then every 2 hours for 24 hours. Pulse, blood pressure, and neurocirculatory checks are performed every 2 hours for 24 hours and then every 4 hours per our nursing protocol.|36-48 hours post-op (until the epidural is stopped)|||participants|||Number
858102|NCT01741259|Secondary|Inadequate Analgesia|Patients routinely get scheduled ibuprofen as an adjunct to the epidural infusion. The record will be reviewed to see if ketorolac is substituted for ibuprofen or other pain medications such as acetaminophen either alone or in combination with oxycodone or other narcotic pain relievers are administered. The record will also be reviewed if an epidural is discontinued earlier than the morning of the second post-operative day to find out if inadequate analgesia was the cause.|36-48 hours post-op (until the epidural is stopped)|||participants|||Number
858103|NCT01741259|Secondary|Dysphoria|The incidence of dysphoria will be captured when a nurse calls the anesthesia team to alert them. This information is tracked on the physician rounding sheet. The record will also be reviewed if an epidural is discontinued earlier than the morning of the second post-operative day to find out if dysphoria was the cause.|36-48 hours post-op (until epidural is stopped)|||participants|||Number
858104|NCT01741259|Secondary|Pruritus|The incidence of pruritus will be estimated by the administration of diphenhydramine or nalbuphine during the study period as recorded in the patient record.|36-48 hours post-op (until the epidural is stopped)|||participants|||Number
858105|NCT01741259|Secondary|Nausea and Vomiting|The incidence of nausea and vomiting will be estimated by the administration of ondansetron during the study period as recorded in the patient record.|36-48 hours post-op (until epidural is stopped)|||participants|||Number
858106|NCT01741259|Primary|Verbal Pain Score With Movement|Verbal Pain Score on a 0-10 scale is recorded by the nurse at 0, 4, 8, 12, 16, 20, 24, 28, 32, 36,40, 44, and 48 hours after transfer to the post-partum floor. On this scale, 0 represents no pain at all and 10 represents the worst pain imaginable. Because we were relying on nurses to capture this data in the course of normal patient care, scores within 1 hour before or after the goal time were accepted. For each patient, the average of all pain scores was taken and this was considered to be the average pain score while the epidural meperidine was being given.|36-48 hours post-op (until epidural is stopped)|||units on a scale||Standard Deviation|Mean
858107|NCT01709409|Secondary|Curosurf-01|7. Mortality prior to discharge|36 weeks GA||||||
858108|NCT01709409|Secondary|Curosurf-01|6. Bronchopulmonary dysplasia, defined as oxygen or respiratory support requirement at 36 weeks corrected GA|36 Weeks GA||||||
858109|NCT01709409|Secondary|Curosurf-01|5. Adverse events during or after administration of surfactant|36 weeks GA||||||
858110|NCT01709409|Secondary|Curosurf-01|4. Number of doses of surfactant received|36 weeks GA||||||
858111|NCT01709409|Secondary|Curosurf-01|3. Total duration of respiratory support (ventilator and nCPAP) and total number of days of oxygen requirement|36 weeks GA||||||
858112|NCT01709409|Secondary|Curosurf-01|2. Duration of first intubation (in hours/days)|36 weeks GA||||||
858113|NCT01709409|Secondary|To Compare the Duration of Respiratory Support, Extubation Failure Rates, Need for Additional Surfactant Doses, Adverse Events (During and Following Administration), Survival and Pulmonary Morbidities During Hospital Admission Between the Two Groups.|1. Extubation failure|36 weeks GA||||||
858114|NCT01709409|Primary|The Primary Objective of the Study is to Compare Between the Two Groups, the Number of Subjects Alive and Extubated at 48 Hours Post Surfactant Administration. Extubation|"rate on ventilator ≤40 per minute and
mean airway pressure ≤ 10 cm H20 and
fi02 ≤ 30%"|48 hours|||Participants|||Count of Participants
858143|NCT01665599|Secondary|Pharmacokinetics of DHT Measuring Tmax|A validated LC/MS/MS method was used to determine the levels of DHT.|Day 1; Day 90|ITT population was used which comprised of all participants who received at least one dose of IMP.||hour||Full Range|Median
858144|NCT01665599|Secondary|Pharmacokinetics of DHT (Dihydrotestosterone) Measuring AUCτ|A validated LC/MS/MS method was used to determine the levels of DHT.|Day 1; Day 90|ITT population was used which comprised of all participants who received at least one dose of IMP.||ng*hr/dL||Standard Deviation|Mean
858145|NCT01665599|Secondary|Pharmacokinetics of Total Testosterone Measuring Time of Minimum Observed Concentration (Tmin)|A validated LC/MS/MS method was used to determine the levels of total testosterone.|Day 1; Day 90|ITT population was used which comprised of all participants who received at least one dose of IMP.||hour||Full Range|Median
858136|NCT01665599|Secondary|Change From Baseline in the SF-12 Health Questionnaire|"Data collected from the SF-12 questionnaire was used to assess improvement in the psychometrically-based physical component summary (PCS) and mental component summary (MCS). Both PCS and MCS contains four sub-domains:
PCS: General Health (1 item), Physical Functioning (2 items), Role-Physical (2 items), Bodily Pain (1 item)
MCS: Role-Emotional (2 items), Mental Health (2 items), Vitality (1 item), Social Functioning (1 item)
The scale scores are calculated by summing responses across scale items and then transforming these raw scores to a 0–100 scale. Computerized scoring algorithms are used to produce norm-based scores for each scale (mean of 50 and standard deviation of 10) as well as the PCS and MCS summary scores. A zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
The data were presented using descriptive statistics."|Day 91|ITT population was used which comprised of all participants who received at least one dose of IMP.||units on a scale||Standard Deviation|Mean
858137|NCT01665599|Secondary|Change From Baseline in the Multidimensional Assessment of Fatigue (MAF) Questionnaire|"The MAF contains four sub-domains:
Severity (2 items, questions 1-2) (Score range: 2-20)
Distress (1 item, question 3) (Score range: 1-10)
Degree of interference in activities of daily living (11 items, questions 4-14) (Score range: 11-110)
Timing (2 items, questions 15-16) (Score range: 5-20)
A score of 1-10 is awarded to each of the 14 questions across the 3 domains. The timing domain is categorical and was converted to 1-10 scale by multiplying each score by 2.5. Lower score in each domain indicates improvement in fatigue.
To calculate GFI : Score of question 15 is converted to a 0-10 scale by multiplying each score by 2.5 and then sum questions 1, 2, 3, average of 4-14, and newly scored question 15. A score of zero is assigned to question 2-16, if patient select 'no fatigue' to question 1. Question 16 is not included in GFI calculation. Range of GFI: 1 (no fatigue) to 50 (severe fatigue).
The data were presented using descriptive statistics."|Day 91|ITT population was used which comprised of all participants who received at least one dose of IMP.||units on a scale||Standard Deviation|Mean
858138|NCT01665599|Secondary|Change From Baseline in the International Index of Erectile Dysfunction (IIEF) Questionnaire|"Data collected from the five domains of sexual functions were summarized by descriptive statistics. The domains are:
Erectile function (6 items, questions 1-5 and 15) (Score range: 1-30)
Orgasmic function (2 items, questions 9-10) (Score range: 0-10)
Sexual desire (2 items, questions 11-12) (Score range: 2-10)
Intercourse satisfaction (3 items, questions 6-8) (Score range: 0-15)
Overall satisfaction (2 items, questions 13-14) (Score range: 2-10)
A score of 0-5 is awarded to questions 1 to 10 and a score of 1-5 is awarded to questions 11 to 15. Total score was calculated by summing up scores of each domain and ranged from 5 to 75. Low score indicates severe dysfunction and a high score indicates no dysfunction in sexual function."|Day 91|ITT population was used which comprised of all participants who received at least one dose of IMP.||units on a scale||Standard Deviation|Mean
858149|NCT01665599|Secondary|Pharmacokinetics of Total Testosterone Measuring Time of Maximum Observed Concentration (Tmax)|A validated LC/MS/MS method was used to determine the levels of total testosterone.|Day 1; Day 90|ITT population was used which comprised of all participants who received at least one dose of IMP.||hour||Full Range|Median
858150|NCT01665599|Secondary|Pharmacokinetics of Total Testosterone Measuring Area Under the Concentration-time Curve From the Last Dose and 24 Hours Post-dose (AUCτ)|A validated high pressure liquid chromatography with tandem mass spectrometry detection (LC/MS/MS) method was used to determine the levels of total testosterone.|Day 1; Day 90|ITT population was used which comprised of all participants who received at least one dose of IMP.||ng*hr/dL||Standard Deviation|Mean
858151|NCT01665599|Secondary|The Percentage of Participants on Day 1 Whose Serum Cavg (0-24) Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL|The data were presented using descriptive statistics. No statistical analysis was performed.|Day 1|FAS population was used which comprised of subjects who had any available PK data for testosterone on Day 90.||percentage of participants|||Number
858152|NCT01665599|Primary|The Percentage of Subjects on Day 90 Whose Cavg (0-24) Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL|The data were presented using descriptive statistics. No statistical analysis was performed.|Day 90|Full Analysis set (FAS) population was used which comprised of subjects who had any available pharmacokinetic (PK) data for testosterone on Day 90.||percentage of participants|||Number
858153|NCT01655719|Other Pre-specified|Lipid Accumulation in Tumor|Determine (by MRI) if pioglitazone induces lipid accumulation in follicular-patterned thyroid carcinomas that contain the PAX8-PPARgamma fusion gene.|24 weeks||||||
858154|NCT01655719|Other Pre-specified|Sensitization to Radioiodine Therapy|Determine if pioglitazone induces a clinically significant level of radioiodine uptake in the residual thyroid carcinoma, and if so, whether there is a therapeutic response to radioiodine. This will be addressed in a separate follow-up protocol available to subjects completing this study.|24 weeks||||||
858155|NCT01655719|Other Pre-specified|Biomarkers|Define predictive markers of response or insensitivity to pioglitazone. Unstained tumor tissue slides from archival paraffin blocks, fresh biopsy specimens from measurable metastases, and blood samples (serum and peripheral blood cells) will be collected on enrolled patients who consented for the optional correlative studies. These will be used to identify factors that predict efficacy of pioglitazone. Analyses may include measures of expression of specific RNAs and proteins, and DNA sequence analysis.|24 weeks||||||
858156|NCT01655719|Secondary|Toxicity|Toxicities experienced by patients with PAX8-PPARgamma fusion gene-positive follicular-patterned thyroid carcinomas treated with pioglitazone are indicated by presence of Serious Adverse Events (that show relatedness).|24 weeks|||serious adverse events|||Number
858157|NCT01655719|Secondary|Change in Serum Thyroglobulin|Determine if pioglitazone decreases serum thyroglobulin in patients with follicular-patterned thyroid carcinomas that contain the PAX8-PPARgamma fusion gene.|Baseline and 24 weeks|||ng/mL|||Number
858158|NCT01655719|Primary|Tumor Response (Change)|Response is measured by change in Tumor size (cm)|Baseline and 24 weeks|||cm|||Number
858159|NCT01650545|Secondary|Cytokine Analysis From BAL Fluid in Lung|This is a surrogate marker of lung inflammation that may be used in addition to biopsy data|2 years||||||
858160|NCT01650545|Primary|Number Of Participants With Chronic Rejection Who Expired||up to 5 years|||Participants|||Count of Participants
858161|NCT01650545|Primary|The Number of Lung Allograft Recipients Randomized With Bronchiolitis Obliterans Whom Had Progression of Disease in the L-CsA Arm Versus the Standard of Care Arm Receiving Conventional Immune Suppression Exclusively.|Bronchiolitis obliterans syndrome (BOS) progression of disease defined by >= 20% decline in FEV1 from randomization or re-transplant of the lung allograft or death|1 year post randomization|||Participants|||Count of Participants
858168|NCT01624233|Secondary|Number of Participants Achieving ACR20|ACR20 response is defined as ≥20% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: participant's assessment of Joint Pain VAS, Patient’s Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, participant's assessment of physical function using the HAQ-DI, or CRP or the ESR.|Wk 100 and Wk 292||09/2018||||
858169|NCT01624233|Secondary|Change From Baseline in Participants Assessment of Joint Pain VAS|The pain VAS is a participant-administered single-item scale designed to measure current joint pain from PsA using a 100-mm horizontal VAS. Overall severity of participant's joint pain from PsA is indicated by placing a single mark on the horizontal 100-mm scale from 0mm (no pain) to 100 mm (pain as severe as you can imagine).|Baseline, Wk 100; Baseline, Wk 292||09/2018||||
858170|NCT01624233|Secondary|Change From Baseline in DLQI Score|DLQI is a participant-administered, 10-question, validated, quality-of-life questionnaire that covers 6 domains, including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include 0 (not at all), 1 (a little), 2 (a lot), and 3 (very much) and unanswered (“not relevant”) responses were scored as “0.” Total scores range from 0 to 30, with higher scores indicating greater quality of life impairment. A 5-point increase in total score from baseline is considered clinically relevant.|Baseline, Wk 100; Baseline, Wk 292||09/2018||||
858171|NCT01624233|Secondary|Change From Baseline in Itch NRS Score|The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 (no itch) and 10, (worst itch imaginable). Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours.|Baseline, Wk 100; Baseline, Wk 292||09/2018||||
858172|NCT01624233|Secondary|Change From Baseline in QIDS-SR16 Score|QIDS-SR16 is a participant-administered, 16-item instrument intended to assess the existence and severity of symptoms of depression. A participant is asked to consider each statement as it relates to the way they have felt for the past 7 days and rate each on a 4-point scale: 0 (best) to 3 (worst) scale. The sum of the 16 items corresponding to 9 depression domains [sad mood, concentration, self-criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance (initial, middle and late insomnia or hypersomnia), decrease/increase in appetite/weight, and psychomotor agitation/retardation] give a single total scores range from 0 to 27, with higher scores indicating greater symptom severity.|Baseline, Wk 100; Baseline, Wk 292||09/2018||||
858173|NCT01624233|Secondary|Change From Baseline in PSSI|The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (<10%) to 6 (90%-100%) with a total scores range from 0 to 72, with lower scores indicating less severity.|Baseline, Wk 100; Baseline, Wk 292||09/2018||||
858174|NCT01624233|Secondary|Change From Baseline in NAPSI|The NAPSI is a numeric, reproducible, objective tool for evaluation of fingernail Ps. This scale is used to evaluate the severity of fingernail bed Ps and fingernail matrix Ps by area of involvement in the fingernail unit. The fingernail is divided with imaginary horizontal and longitudinal lines into quadrants. Each fingernail is given a score for fingernail bed Ps 0 (none) to 4 (Ps in 4 quadrants of the fingernail) and fingernail matrix Ps 0 (none) to 4 (Ps in 4 quadrants in matrix), depending on the presence (score of 1) or absence (score of 0) of any of the features of fingernail bed or matrix Ps in each quadrant. The NAPSI score of a fingernail is the sum of scores in fingernail bed and fingernail matrix from each quadrant (maximum of 8). Each fingernail is evaluated, then the sum of all the fingernails equals the total NAPSI score with a range 0 to 80. Higher scores indicate more severe psoriasis.|Baseline, Wk 100; Baseline, Wk 292||09/2018||||
858175|NCT01624233|Secondary|Change From Baseline in Percent of BSA Involvement|BSA is a physician rating of the percentage of involvement of Ps for each participant. BSA is assessed on a continuous scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participants hand (includes the palm, fingers and thumb).|Baseline, Wk 100; Baseline, Wk 292||09/2018||||
858176|NCT01624233|Secondary|Percentage of Participants With sPGA (0 or 1) and sPGA (0)|The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear) or 1 (minimal).|Wks 100 and 292||09/2018||||
858177|NCT01624233|Secondary|Percent of Participants Achieving PASI 75%, 90% and/or 100% Improvement|The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated: 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling, with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI=sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).|Wks 100 and 292||09/2018||||
858178|NCT01624233|Secondary|Change From Baseline in Participants Assessment of Joint Pain Visual Analog Scale (VAS) (Efficacy of Ixekizumab in Participants With PsA Pain VAS)|The pain VAS is a participant-administered single-item scale designed to measure current joint pain from PsA using a 100-mm horizontal VAS. Overall severity of participant's joint pain from PsA is indicated by placing a single mark on the horizontal 100-mm scale from 0 mm (no pain) to 100 mm (pain as severe as you can imagine).|Baseline, Wk 12; Baseline, Wk 52|Participants with PsA who had 3 or more tender joints and 3 or more swollen joints at screening and baseline.||mm||Standard Deviation|Mean
858179|NCT01624233|Secondary|Number of Participants Achieving American College of Rheumatology 20% (ACR20) Improvement [Efficacy of Ixekizumab in Participants With Psoriatic Arthritis (PsA) as Measured by ACR20]|ACR20 response is defined as a ≥20% improvement from baseline for tender joint count (TJC) and swollen joint count (SJC) and in at least 3 of the following 5 criteria: participant's assessment of Joint Pain visual analog scale (VAS), Patient’s Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, participant's assessment of physical function using the Health Assessment Questionnaire Disability Index (HAQ-DI), or C-reactive protein (CRP) or the erythrocyte sedimentation rate (ESR).|Wks 12, 24 and 52|Participants with PsA who had 3 or more tender joints and 3 or more swollen joints at screening and baseline.||participants|||Number
858180|NCT01624233|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Score|DLQI is a participant-administered, 10-question, validated, quality-of-life questionnaire that covers 6 domains, including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include 0 (not at all), 1 (a little), 2 (a lot), and 3 (very much) and unanswered (“not relevant”) responses were scored as “0.” Total scores range from 0 to 30, with higher score indicating greater quality of life is impairment. A 5-point increase in total score from baseline is considered clinically relevant.|Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52|Participants with Plaques Ps who had DLQI at baseline and at least 1 post-dose result. Participants with missing DLQI at Wks 12 and 52 were imputed by LOCF.||units on a scale||Standard Deviation|Mean
858181|NCT01624233|Secondary|Change From Baseline in Itch Numeric Rating Scale (NRS) Score|The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 (no itch) and 10 (worst itch imaginable). Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours.|Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52|Participants with Plaque Ps who had Itch NRS at baseline and at least 1 post-dose result. Participants with missing Itch NRS at Wks 12 and 52 were imputed by LOCF.||units on a scale||Standard Deviation|Mean
858182|NCT01624233|Secondary|Change From Baseline in Quick Inventory of Depressive Symptomatology-Self Reported 16 Items (QIDS-SR16) Score [Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO)]|QIDS-SR16 is a participant-administered, 16-item instrument intended to assess the existence and severity of symptoms of depression. A participant is asked to consider each statement as it relates to the way they have felt for the past 7 days and rate each on a 4-point scale: 0 (best) to 3 (worst). The sum of the 16 items corresponding to 9 depression domains [sad mood, concentration, self-criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance (initial, middle and late insomnia or hypersomnia), decrease/increase in appetite/weight, and psychomotor agitation/retardation] to give a single total scores range from 0 to 27, with higher scores indicating greater symptom severity.|Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52|Participants with Plaque Ps who had QIDS-SR16 at baseline and at least 1 post-dose result. Participants with missing QIDS-SR16 at Wks 12 and 52 were imputed by LOCF.||units on a scale||Standard Deviation|Mean
858183|NCT01624233|Secondary|Change From Baseline in Psoriasis Scalp Severity Index (PSSI)|The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (<10%) to 6 (90%-100%) with a total scores range from 0 to 72, with lower scores indicating less severity.|Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52|All participants with Plaque Ps with a PSSI baseline and at least 1 post-dose result. Participants with missing PSSI at Wks 12 and 52 were imputed by LOCF.||units on a scale||Standard Deviation|Mean
858184|NCT01624233|Secondary|Change From Baseline in Nail Psoriasis Severity Index (NAPSI)|The NAPSI is a numeric, reproducible, objective tool for evaluation of fingernail Ps. This scale is used to evaluate the severity of fingernail bed Ps and fingernail matrix Ps by area of involvement in the fingernail unit. The fingernail is divided with imaginary horizontal and longitudinal lines into quadrants. Each fingernail is given a score for fingernail bed Ps 0 (none) to 4 (Ps in 4 quadrants of the fingernail) and fingernail matrix Ps 0 (none) to 4 (Ps in 4 quadrants in matrix), depending on the presence (score of 1) or absence (score of 0) of any of the features of fingernail bed or matrix Ps in each quadrant. The NAPSI score of a fingernail is the sum of scores in fingernail bed and fingernail matrix from each quadrant (maximum of 8). Each fingernail is evaluated, then the sum of all fingernails equals the total NAPSI score with a range from range 0 to 80. Higher scores indicated more severe psoriasis.|Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52|All participants Plaque Ps with NAPSI at baseline and at least 1 post dose result. Participants with missing NAPSI at Wks 12 and 52 were imputed by LOCF.||units on a scale||Standard Deviation|Mean
858185|NCT01624233|Secondary|Change From Baseline in Percent of Body Surface Area (BSA) Involvement|BSA is a physician rating of the percentage of involvement of Ps for each participant. BSA is assessed on a continuous scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participants hand (includes the palm, fingers and thumb).|Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52|All participants with Plaque Ps with a baseline and at least 1 post-dose result. Participants with missing BSA at Wks 12 and 52 were imputed by last observation carried forward (LOCF).||percentage of BSA||Standard Deviation|Mean
858186|NCT01624233|Secondary|Percentage of Participants With Static Physician Global Assessment (sPGA) (0 or 1) or sPGA (0) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis Measure: sPGA)|The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear) or 1 (minimal).|Wks 12, 24 and 52|All participants with Plaque Ps who received at least 1 dose of study drug and had at least 1 post-dose measurement of sPGA after study treatment. Participants who discontinued treatment at any time prior to the specified time points were defined as non-responders for NRI analysis for Wks 12 and 52.||percentage of participants|||Number
858187|NCT01624233|Secondary|Percent of Participants Achieving PASI 90% and 100% Improvement|The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI=sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).|Wks 12, 24 and 52|All participants with Plaque Ps who received at least 1 dose of study drug and had at least 1 post-dose measurement of PASI after study treatment. Participants who discontinued treatment at any time prior to the specified time points were defined as non-responders for NRI at Wks 12 and 52.||percentage of participants|||Number
858188|NCT01624233|Secondary|Number of Participants With Anti-Ixekizumab Antibodies|Treatment-emergent immunogenicity is defined as any occurrence of a 4-fold or 2-dilution increase in titer over the pretreatment baseline titer. In the case of a negative result at baseline, treatment-emergent immunogenicity is defined as an increase in titer to ≥1:10.|Baseline through Wk 52|All participants with Plaque Ps, Pustular Ps or Erythrodermic Ps who received at least 1 dose of study drug.||participants|||Number
858189|NCT01624233|Secondary|Pharmacokinetics (PK): Ctrough at Steady State (Ctrough ss) of Ixekizumab|PK samples were from 1 or 2 sampling cohorts. Ctrough is the minimum observed concentration of ixekizumab at steady state. Steady-state ixekizumab trough concentrations were summarized for the induction dosing period at week 12, the time of the primary efficacy assessment. Steady-state ixekizumab trough concentrations were summarized for the maintenance dosing period at week 24.|Wks 12 and 24|All participants with Plaque Ps, Pustular Ps or Erythrodermic Ps who had at least 1 dose of study drug and evaluable Ctrough data at the specified time points.||micrograms/milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
858190|NCT01624233|Secondary|Percentage of Participants Achieving ≥75% Improvement in PASI|The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region, the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI=sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).|Wks 24 and 52|All participants with Plaque Ps who received at least 1 dose of study drug and had at least 1 measurement of PASI after study treatment. Non-responders and participants who discontinued at any time prior to Wk 52 were defined as non-responders for NRI analysis.||percentage of participants|||Number
858191|NCT01624233|Primary|Percentage of Participants Achieving ≥75% Improvement in Psoriasis Area and Severity Index (PASI) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis. Measure: PASI)|The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI=sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).|Week (Wk) 12|All participants with Plaque Ps who received at least one dose of study drug and had at least 1 measurement of PASI after study treatment. Non-responders and participants who discontinued at any time prior to specified time points were defined as non-responders for Non-Responder Imputation (NRI) analysis.||percentage of participants|||Number
858213|NCT01531374|Secondary|Prosthetic Valve Dysfunction (PVD)|"PVD was defined according to VARC using the site reported echocardiography assessments including aortic regurgitation (AR) and aortic stenosis (AS) evaluations. Total AR reported as moderate or severe was considered PVD. AS was defined as significant stenosis and considered PVD if one of the following was met:
Peak velocity >4 m/s
Mean gradient >35 mmHg
EOA < 0.8 cm2
TVIV1 / TVIV2 < 0.25"|30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.|Participant Population = Consisted of all subjects with a valve implanted.||Percentage of participants|||Number
858214|NCT01531374|Secondary|Procedural Success|Defined as device success and absence of in-hospital MACCE.|Number of days from admission to discharge|Participant Population = Consisted of all subjects with an index procedure who were evaluable for procedural success.||percentage of participants|||Number
858215|NCT01531374|Secondary|Device Success|"Defined as:
Successful vascular access, delivery and deployment of the device, and successful retrieval of the delivery system,
Correct position of the device in the proper anatomical location (placement in the annulus with no impedance on device function),
Intended performance of the prosthetic valve (aortic valve area > 1.2 cm2 for 26, 29 and 31mm valves, ≥ 0.9 cm2 for 23mm valve (by echocardiography using the continuity equation) and mean aortic valve gradient < 20 mmHg or peak velocity < 3 m/sec, without moderate or severe prosthetic valve aortic regurgitation)
Only one valve implanted in the proper anatomical location"|Number of days from admission to discharge|Participant Population= Consisted of all subjects with a TAVR index procedure who were evaluable for device success.||percentage of participants|||Number
858216|NCT01531374|Secondary|Length of Index Procedure Hospital Stay||Number of days from admission to discharge|Participant Population = Consisted of all subjects with an attempted implant procedure.||days||Standard Deviation|Mean
858217|NCT01531374|Secondary|Index Procedure Related MAEs||Procedure|Participant Population = Consisted of all subjects with an attempted implant procedure.||percentage of participants|||Number
858218|NCT01531374|Secondary|Strokes and Transient Ischemic Attacks (TIAs)|Strokes (of any severity) and TIAs|30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.|Participant Population = Consisted of all subjects with an attempted implant procedure.||percentage of participants, Kaplan-Meier|||Number
858219|NCT01531374|Secondary|Cardiovascular Deaths and Valve-Related Deaths||30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.|Participant Population = Consisted of all subjects with an attempted implant procedure.||percentage of participants, Kaplan-Meier|||Number
858220|NCT01531374|Secondary|Aortic Valve Hospitalizations||30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.|Participant Population = Consisted of all subjects with an attempted implant procedure.||percentage of participants, Kaplan-Meier|||Number
858221|NCT01531374|Secondary|Echocardiographic Assessment of Valve Performance|"Using the following measure:
- Degree of Aortic Valve Regurgitation (Transvalvular and Paravalvular) analyzed overall per Extreme Risk or High Risk. Iliofemoral access and non-iliofemoral access are not reported separate because this is a valve performance measurement."|30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.|Participant Population = Consisted of all subjects with a valve implanted.||percentage of participants|||Number
858222|NCT01531374|Secondary|Echocardiographic Assessment of Valve Performance|"Using the following measure:
• Transvalvular Mean Gradient analyzed overall per Extreme Risk or High Risk. Iliofemoral access and non-iliofemoral access are not reported separate because this is a valve performance measurement."|30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.|Participant Population= Consisted of all subjects with a valve implanted.||mmHg||Standard Deviation|Mean
858223|NCT01531374|Secondary|Echocardiographic Assessment of Valve Performance|"Using the following measure:
• Effective Orifice Area (EOA) analyzed overall per Extreme Risk or High Risk. Iliofemoral access and non-iliofemoral access are not reported separate because this is a valve performance measurement."|30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.|Participant Population = Consisted of all subjects with a valve implanted.||cm^2||Standard Deviation|Mean
858224|NCT01531374|Secondary|Quality of Life (QoL) Change|"QoL summary score change from baseline using the following measures:
Kansas City Cardiomyopathy Questionnaire (KCCQ): Quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
12 Item Short Form Health Survey (SF-12): Measures functional health and well-being. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
European QoL (EQ-5D): Measures 5 domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that can be converted to utilities using an algorithm. Utilities range from 0 to 1, with 1 representing perfect health, and 0 corresponding to the worst imaginable health state."|30 day, 6 month, 1 year. The 2-5 year outcome data will be reported once data set is complete.|Participant Population = Consisted of all subjects with an attempted implant procedure.||units on a scale||Standard Deviation|Mean
858225|NCT01531374|Secondary|Ratio of Days Alive Out of Hospital at 365 Days Post Procedure Versus Total Days Alive||1 year|Participant Population= Consisted of all subjects with an attempted implant procedure.||ratio of days alive and out of hospital||Standard Deviation|Mean
858226|NCT01531374|Secondary|Change From Baseline in Distance Walked During 6-Minute Walk Test (6MWT)|Change in distance walked during 6MWT from baseline|Baseline to 30 days, baseline to 1 year|Participant Population = Consisted of all subjects with an attempted implant procedure.||meters||Standard Deviation|Mean
858227|NCT01531374|Secondary|Change From Baseline in NYHA Class|"Change from baseline (continuous variable). A positive number corresponds to NYHA worsening; a negative number corresponds to NYHA improvement.
NYHA Classification:
Class I: Subjects with cardiac disease but without resulting limitations of physical activity.
Class I: Subjects with cardiac disease resulting in slight limitation of physical activity.
Class III: Subjects with cardiac disease resulting in marked limitation of physical activity.
Class IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort."|Baseline to 30 days, baseline to 6 months, baseline to 1 year. The 2-5 year outcome data will be reported once data set is complete.|Participant Population = Consisted of all subjects with an attempted implant procedure.||average classification level change||Standard Deviation|Mean
858228|NCT01531374|Secondary|Conduction Disturbance Requiring Permanent Pacemaker Implantation||30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.|Participant Population = Consisted of all subjects with an attempted implant procedure.||percentage of participants, Kaplan-Meier|||Number
858229|NCT01531374|Secondary|Major Adverse Events (MAEs)|"MAEs Include:
MACCE
Acute Kidney Injury
Cardiac Tamponade
Prosthetic Valve Dysfunction
Cardiogenic Shock
Valve Endocarditis
Life-Threatening, Disabling or Major Bleeding
Major Vascular Complication
Cardiac Perforation
Device Migration/Valve Embolism"|30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.|Participant Population = Consisted of all subjects with an attempted implant procedure.||percentage of participants, Kaplan-Meier|||Number
858230|NCT01531374|Secondary|The Occurrence of Individual MACCE Components|"Individual MACCE Components Include:
All Cause Mortality
MI
All stroke
Reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)"|30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.|Participant Population = Consisted of all subjects with an attempted implant procedure.||percentage of participants, Kaplan-Meier|||Number
858231|NCT01531374|Secondary|Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)|"MACCE is defined as a composite of:
All-Cause Death
Myocardial Infarction (MI)
All Stroke
Reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)"|30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.|Participant Population = Consisted of all subjects with an attempted implant procedure.||percentage of participants, Kaplan-Meier|||Number
858232|NCT01531374|Primary|Extreme Risk: All-cause Death or Major Stroke; High Risk Surgical: All-cause Mortality|All-cause Death or Major Stroke (Extreme Risk- Medtronic CoreValve® System); All-cause Mortality (High Risk Surgical- Medtronic CoreValve® System vs. Surgical Valve)|1 year|Participant Population = Consisted of all subjects with an attempted implant procedure.||percentage of participants, Kaplan-Meier|||Number
858244|NCT01449929|Secondary|Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Convenience Score at Week 4, Week 24, and Week 48|Participant treatment satisfaction was measured using the self-reported scale (HIVTSQ), which consists of 10 items (1-satisfaction, 2-HIV control, 3-adverse effects, 4-level of demand, 5-convenience, 6-flexibility, 7-knowledge, 8-life habits, 9-recommendability, and 10-willingness to continue). Items are scored from 0 (very dissatisfied) to 6 (very satisfied), other than item 4, which has an inverted score from 6 (very demanding) to 0 (very undemanding). The convenience score is the score for item 5 (range: 0-6).|Week 4, Week 24, and Week 48|HIVTSQ mITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different visits, so the overall number of participants analyzed reflects everyone in the HIVTSQ mITT-E population.||Scores on a scale||Standard Deviation|Mean
858245|NCT01449929|Secondary|Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Lifestyle/Ease Sub Score at Week 4, Week 24, and Week 48|Participant treatment satisfaction was measured using the self-reported scale (HIVTSQ), which consists of 10 items (1-satisfaction, 2-HIV control, 3-adverse effects, 4-level of demand, 5-convenience, 6-flexibility, 7-knowledge, 8-life habits, 9-recommendability, and 10-willingness to continue). Items are scored from 0 (very dissatisfied) to 6 (very satisfied), other than item 4, which has an inverted score from 6 (very demanding) to 0 (very undemanding). The lifestyle/ease score is the sum of items 4, 5, 6, 7 and 8 (range: 0-30).|Week 4, Week 24, and Week 48|HIVTSQ mITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different visits, so the overall number of participants analyzed reflects everyone in the HIVTSQ mITT-E population.||Scores on a scale||Standard Deviation|Mean
858246|NCT01449929|Secondary|Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Total Score at Week 4, Week 24, and Week 48|Participant treatment satisfaction was measured using the self-reported scale (HIVTSQ), which consists of 10 items (1-satisfaction, 2-HIV control, 3-adverse effects, 4-level of demand, 5-convenience, 6-flexibility, 7-knowledge, 8-life habits, 9-recommendability, and 10-willingness to continue). Items are scored from 0 (very dissatisfied) to 6 (very satisfied), other than item 4, which has an inverted score from 6 (very demanding) to 0 (very undemanding). The treatment satisfaction score (range: 0-60) was the sum of the individual items. HIVTSQ mITT-E Population=Only participants from USA, France, Germany, Italy, Spain for whom valid translations were available from the mITT-E Population.|Week 4, Week 24, and Week 48|HIVTSQ mITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different visits, so the overall number of participants analyzed reflects everyone in the HIVTSQ mITT-E population.||Scores on a scale||Standard Deviation|Mean
858247|NCT01449929|Secondary|Change From Baseline in EQ-5D Thermometer Scores at Week 24 and Week 48|The European Quality of Life -5 Dimensions (EQ-5D) is a 5-question quality of life instrument that provides a utility score and visual analogue scale score that describes the participants’ health status. The primary reason for including the EQ-5D is to elicit utility values for potential cost-effectiveness analysis for submission to health technology assessment agencies. Thermometer score is based on a visual analogue scale (VAS) ranging from 100 (best imaginable health state) to 0 (worst imaginable health state).Values represented are for adjusted mean. Estimates are calculated from an ANCOVA model adjusting for age, sex, race, Baseline viral load, background dual NRTI therapy and Baseline EQ-5D thermometer score. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline, Week 24, and Week 48|mITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different visits, so the overall number of participants analyzed reflects everyone in the mITT-E Population.||Scores on a scale||Standard Error|Mean
858248|NCT01449929|Secondary|Change From Baseline in EQ-5D Utility Scores at Week 24 and Week 48|The European Quality of Life -5 Dimensions (EQ-5D) is a 5-question quality of life instrument that provides a utility score and visual analogue scale score that describes the participants’ health status. The primary reason for including the EQ-5D is to elicit utility values for potential cost-effectiveness analysis for submission to health technology assessment agencies. The EQ-5D total score ranges from 0 (worst health state) to 1 (perfect health state) and 1 reflects the best outcome. Values represented are for adjusted mean. Estimates are calculated from an ANCOVA model adjusting for age, sex, race, baseline viral load, background dual NRTI therapy and Baseline EQ-5D utility score. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline, Week 24, and Week 48|mITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different visits, so the overall number of participants analyzed reflects everyone in the mITT-E Population.||Scores on a scale||Standard Error|Mean
858249|NCT01449929|Secondary|Change From Baseline in Acquired Immune Deficiency Syndrome (AIDS) Clinical Trials Group (ACTG) Symptom Distress Module (SDM) Bother Score at Week 4, Week 24, and Week 48|SDM is a 20-item self-reported measure that addresses the presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. Each item is rated from 0 to 4 where 0 (complete absence of symptom) and 4 (very bothersome symptom). Overall score calculated as the sum of the scores for each of the 20 items of the questionnaire and ranged from 0 (best health) and 80 (worst health). Values represented are for adjusted mean. Estimates are calculated from an ANCOVA model adjusting for age, sex, race, baseline viral load, background dual NRTI therapy and baseline symptom bother score. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. A positive change from Baseline indicates a decline in a participant’s quality of life over that period.|Baseline, Week 4, Week 24, and Week 48|mITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different visits, so the overall number of participants analyzed reflects everyone in the mITT-E Population.||Scores on a scale||Standard Error|Mean
858250|NCT01449929|Secondary|Number of Participants (Par.) With Detectable Virus That Has Genotypic or Phenotypic Evidence of Treatment-emergent Resistance to DTG, DRV+RTV and Other On-study ART at Time of Protocol Defined Virology Failure (PDVF)|An assessment was made of every change across all amino acids within the integrase (IN), reverse transcriptase (RT), and Protease (PRO) encoding region at Baseline and at time of suspected PDVF. PDVF is defined as the confirmed plasma HIV-1 RNA >200 c/mL >=Week 24.|Baseline until PDVF up to Week 48|PDVF Genotypic Population: all participants in the mITT-E population with available on-treatment genotypic resistance data, at time of PDVF. Only those participants with data available at the specified time points were analyzed.||Participants|||Number
858251|NCT01449929|Secondary|Number of Participants With the Indicated Grade 3 and Grade 4 Maximum Post-Baseline Chemistry and Hematology Laboratory Toxicities|Hematology and clinical chemistry data were summarized according to the division of AIDS (DAIDS) table for grading the Severity of adverse events, version 1.0. Grade 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to Grade 3 or Grade 4 occurred.|From Baseline through Week 48|mSafety Population||Participants|||Number
858252|NCT01449929|Secondary|Percentage of Participants With Grade 2 or Higher Abnormalities in Fasting LDL Cholesterol Through Week 48|Hematology and clinical chemistry data were summarized according to the division of AIDS (DAIDS) table for grading the Severity of adverse events, version 1.0. Grade 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for which an increase in fasting LDL cholesterol to Grade 2 or higher occurred.|From Baseline through Week 48|mSafety Population. Only those participants with data available at the specified time points were analyzed.||Percentage of Participants|||Number
858253|NCT01449929|Secondary|Change From Baseline in Fasting Low-density Lipoprotein (LDL) Cholesterol Through Week 48|Fasting LDL cholesterol change from Baseline was analyzed. Values represented are for adjusted means. Estimates are calculated from a repeated measures model including the following covariates: treatment, visit, Baseline plasma HIV-1 RNA, background dual NRTI therapy, Baseline LDL cholesterol, treatment*visit interaction and Baseline LDL cholesterol*visit interaction. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|From Baseline through Week 48|mSafety Population. Only those participants with data available at the specified time points were analyzed.||millimoles per liter (mmol/L)||Standard Error|Mean
858254|NCT01449929|Secondary|Number of Participants With HIV-1 Associated Disease Progression With the Indicated Shift to CDC Class C, or New CDC Class C or Death at Week 48|The number of participants with HIV-1 disease progression (AIDS or death) was assessed per the Centers for Disease Control and Prevention (CDC) 1993 revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescents and adults. The CDC classifies HIV infection as Category A (participants with asymptomatic HIV infection, acute HIV infection with accompanying illness, or persistent generalized lymphadenopathy), Category B (participants with symptomatic non-AIDS condition, i.e., conditions that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or conditions are considered by physicians to have a clinical course or to require management that is complicated by HIV infection), and Category C (includes AIDS indicator conditions as defined by diagnostic or presumptive measures).|Week 48|mITT-E Population||Participants|||Number
858255|NCT01449929|Secondary|Change From Baseline in CD4+ and CD8+ Cell Counts|Change from Baseline in CD4+ cell counts was assessed at Weeks 4, 8, 12, 16, 36 and 48. Change from Baseline in CD8+ cell counts was assessed at Weeks 4, 12, 24 and 48. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Weeks 4, 8, 12, 16, 36 and 48 for CD4+ and Baseline and Weeks 4, 12, 24 and 48 for CD8+|mITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different visits and parameters, so the overall number of participants analyzed reflects everyone in the mITT-E Population.||Cells per millimeters cubed (cells/mm^3)||Standard Deviation|Mean
858256|NCT01449929|Secondary|Change From Baseline in Plasma HIV-1 RNA (log10 c/mL) at Weeks 4, 8, 12, 16, 24, 36 and 48|Change from Baseline in plasma HIV-1 RNA (log10 c/mL) was assessed at Weeks 4, 8, 12, 16, 24, 36 and 48 . Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline, Weeks 4, 8, 12, 16, 24, 36 and 48|mITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different visits, so the overall number of participants analyzed reflects everyone in the mITT-E Population.||Log10 copies per mL||Standard Deviation|Mean
858257|NCT01449929|Secondary|Percentage of Participants With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <400 c/mL at Week 48|"The percentage of participants with Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) <400 c/mL at Week 48 was assessed using Missing, Switch or Discontinuation = Failure (MSDF), as codified by the Food and Drug Administration (FDA) snapshot algorithm. This algorithm treated all participants without HIV-1 RNA data at Week 48 as nonresponders, as well as participants who switched their concomitant ART prior to Week 48 as follows: background ART substitutions non-permitted per protocol (one background ART substitution was permitted for safety or tolerability); background ART substitutions permitted per protocol unless the decision to switch was documented as being before or at the first on-treatment visit where HIV-1 RNA was assessed. Otherwise, virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment in the snapshot window (Week 48 +/- 6 weeks)."|Week 48|mITT-E Population||Percentage of participants|||Number
858258|NCT01449929|Secondary|Time to Virologic Suppression (<50 Copies/mL) Through Week 48|The time to viral suppression (i.e. first viral load value <50 copies/mL) through Week 48 was derived and summarized using Kaplan-Meier plots. Participants who withdrew for any reason without having suppressed prior to the analysis were censored. Confidence intervals were estimated using the Brookmeyer-Crowley method.|From Baseline through Week 48|mITT-E Population||Days||95% Confidence Interval|Median
858259|NCT01449929|Primary|Percentage of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) at Week 48|"The percentage of participants with Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) <50 c/mL at Week 48 was assessed using Missing, Switch or Discontinuation = Failure (MSDF), as codified by the Food and Drug Administration (FDA) snapshot algorithm. This algorithm treated all participants without HIV-1 RNA data at Week 48 as nonresponders, as well as participants who switched their concomitant ART prior to Week 48 as follows: background ART substitutions non-permitted per protocol (one background ART substitution was permitted for safety or tolerability); background ART substitutions permitted per protocol unless the decision to switch was documented as being before or at the first on-treatment visit where HIV-1 RNA was assessed. Otherwise, virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment in the snapshot window (Week 48 +/- 6 weeks)."|Week 48|Modified Intent-To-Treat Exposed (mITT-E) Population: all randomized participants who received at least one dose of investigational product excluding one participant at one site, which was closed due to Good Clinical Practice (GCP) non-compliance issues in another ViiV Healthcare sponsored trial.||Percentage of participants|||Number
858349|NCT01311687|Secondary|Time to First Worsening of Quality of Life (QOL) Domains|"Time to worsening in quality of life domains was calculated as the time from Baseline to the first worsened minimally important difference (MID), defined as the smallest change in a QOL score considered important to patients that would lead the patient or clinician to consider a change in therapy. MID thresholds were calculated in Standard Error of Measurement (SEM) units using the Baseline QOL data. Based on the MID, participants were classified as worsened according to the following:
For the EORTC QLQ-C30 global health status and functional scales and the EQ-5D health utility score, participants were classified as worsened if their change from Baseline score was less than -1 SEM.
For the EORTC QLQ-C30 symptom scores (fatigue and pain) and EORTC QLQ-MY20 disease symptoms and side effects scales, participants were classified as worsened if their change from Baseline score was greater than 1 SEM.
See previous outcome measures for definitions of each scale."|Assessed on Day 1 of the first 6 treatment cycles.|PRO population||days||95% Confidence Interval|Median
858350|NCT01311687|Primary|Progression-free Survival (PFS) With a Later Cut-off Date|"Progression-free survival was calculated as the time from randomization to disease progression as determined by the Independent Response Adjudication Committee based on the International Myeloma Working Group Uniform Response criteria (IMWG), or death on study, whichever occurred earlier.
Progressive disease requires 1 of the following:
Increase of ≥ 25% from nadir in:
Serum M-component (absolute increase ≥ 0.5 g/dl);
Urine M-component (absolute increase ≥ 200 mg/24 hours);
Bone marrow plasma cell percentage (absolute % ≥ 10%);
Development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas;
Development of hypercalcemia (corrected serum calcium > 11.5 mg/dl) attributed solely to plasma cell proliferative disease."|From randomization until the data cut-off date of 01 March 2013. Maximum duration of follow-up for PFS assessments was 74 weeks.|Intent-to-treat population||weeks||95% Confidence Interval|Median
858351|NCT01311687|Secondary|Change From Baseline in the European Quality of Life-5 Dimensions (EQ-5D) Utility Index Score|EQ-5D is a self-administered questionnaire that assesses health-related quality of life (QOL). The EQ-5D descriptive health profile comprises five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension has 3 levels of response: No problem (1), some problems (2), and extreme problems (3). A unique EQ-5D health state is defined by combining one level from each of the five dimensions into a single utility index score. EQ-5D index values range from -0.59 to 1.00 where an EQ-5D score of 1.00 equals “perfect health”, a score of 0 equals “death” and a score of -0.59 equals worst imaginable health state. A positive change from Baseline score indicates improvement in health status. A negative change from Baseline score indicates worsening in health status. Negative scores represent the possible though unlikely situation that a patient's QOL is worse than death, i.e. they would rather be dead than living with that QOL|Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6|"PRO population with available data at Baseline and each time point (indicated by n)."||units on a scale||Standard Deviation|Mean
858409|NCT01245062|Secondary|PFS in BRAF V600E Mutation-positive Participants Without a History of Brain Metastases and With Prior Chemotherapy as Assessed by the Investigator|PFS is defined as the time from the date of randomization to the first documented occurrence of PD or death. Investigator-assessed PFS was summarized per RECIST, Version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions, or the worsening of non-target lesions significant enough to require study treatment discontinuation.|Day 1 until the earliest date of disease progression or death due to any cause (average of 4.8 months)|Primary Efficacy Population. Only those participants with prior chemotherapy were analyzed.||Months||95% Confidence Interval|Median
858352|NCT01311687|Secondary|Change From Baseline in the EORTC QLQ-MY20 Side Effects Domain|"The European Organization for Research and Treatment of Cancer QoL Questionnaire for Patients with Multiple Myeloma (EORTC QLQ-MY20) is a 20-question tool used in clinical research to assess health-related quality of life in multiple myeloma patients. The QLQ-MY20 includes four domains (Disease Symptoms, Side-Effects of Treatment, Body Image and Future Perspective).
The EORTC QLQ-MY20 Side Effects Scale is scored between 0 and 100, with a high score reflecting a higher level of symptoms. Negative change from Baseline values indicate reduction in side effects (i.e.improvement in symptom) and positive values indicate increase in side effects (i.e. worsening of symptom)."|Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6|"PRO population with available data at Baseline and each time point (indicated by n)."||units on a scale||Standard Deviation|Mean
858353|NCT01311687|Secondary|Change From Baseline in the European Organization for Research and Treatment of Cancer QoL Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms|"The European Organization for Research and Treatment of Cancer QoL Questionnaire for Patients with Multiple Myeloma (EORTC QLQ-MY20) is a 20-question tool used in clinical research to assess health-related quality of life in multiple myeloma patients. The QLQ-MY20 includes four domains (Disease Symptoms, Side-Effects of Treatment, Body Image and Future Perspective).
The EORTC QLQ-MY20 Disease Symptoms Scale is scored between 0 and 100, with a high score reflecting a higher level of symptoms. Negative change from Baseline values indicate reduction (i.e. improvement) in symptoms and positive values indicate increase (i.e. worsening) of symptoms."|Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6|"PRO population with available data at Baseline and each time point (indicated by n)."||units on a scale||Standard Deviation|Mean
858354|NCT01311687|Secondary|Change From Baseline in the EORTC QLQ-C30 Pain Domain|"The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).
The EORTC QLQ-C30 Pain Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reductions in pain (i.e. improvement in symptom) and positive values indicate increases in pain (i.e. worsening of symptom)."|Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6|"PRO population with available data at Baseline and each time point (indicated by n)."||units on a scale||Standard Deviation|Mean
858355|NCT01311687|Secondary|Change From Baseline in the EORTC QLQ-C30 Fatigue Domain|"The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).
The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reduction in fatigue (i.e. improvement in symptom) and positive values indicate increases in fatigue (i.e. worsening of symptom)."|Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6|"PRO population with available data at Baseline and each time point (indicated by n)."||units on a scale||Standard Deviation|Mean
858356|NCT01311687|Secondary|Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Domain|"The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).
The EORTC QLQ-C30 Emotional Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement."|Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6|"PRO population with available data at Baseline and each time point (indicated by n)."||units on a scale||Standard Deviation|Mean
858357|NCT01311687|Secondary|Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain|"The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).
The EORTC QLQ-C30 Physical Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement."|Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6|"PRO population with available data at Baseline and each time point (indicated by n)."||units on a scale||Standard Deviation|Mean
858358|NCT01311687|Secondary|Change From Baseline in the European Organization for Research and Treatment of Cancer Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Health Status Domain|"The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).
The EORTC QLQ-C30 Global Health Status/QOL scale is scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in QOL or functioning and positive values indicate improvement."|Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6|"The Patient Reported Outcomes (PRO) study population includes any intent-to-treat study participants with 1 active treatment and 1 PRO measurement item completed. Only participants with available data at Baseline and each time point (indicated by n) are included."||units on a scale||Standard Deviation|Mean
858359|NCT01311687|Secondary|Time to Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status|"Time to improvement in ECOG performance status defined as the time from randomization until at least a one category improvement from Baseline in ECOG performance status score.
The categories of the ECOG Performance Status Scale are as follows:
0: Fully active, able to carry on all pre-disease performance without restriction;
1: Restricted in physically strenuous activity but ambulatory and able to carry our work of a light or sedentary nature, e.g., light housework, office work;
2: Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.
Patients with a score of 3, 4 or 5 were excluded from participating in the study."|From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks.|Intent-to-treat population with improvement in ECOG performance status during the study||weeks||Full Range|Median
858360|NCT01311687|Secondary|Time to Improvement in Renal Function|"Time to improvement in renal function is defined as the time from randomization to at least one category improvement from Baseline in renal function.
Renal Function was categorized as (from best to worst):
Normal: creatinine clearance ≥80 mL/min;
Grade 1: creatinine clearance ≥60 to <80 mL/min;
Grade 2 : creatinine clearance ≥45 to < 60 mL/min.
Participants with creatinine clearance < 45 mL/min at baseline were be excluded from the study."|From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks.|Intent-to-treat population with improvement in renal function||weeks||Full Range|Median
858361|NCT01311687|Secondary|Time to Improvement in Bone Pain|"Time to improvement in bone pain is defined as the time from randomization to at least one category improvement from Baseline in bone pain category.
Bone pain was categorized (from best to worst) according to answers to the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for patients with Multiple Myeloma Module (QLQ-MY20), Question 1, “Have you had bone aches or pain?”:
Not at all,
A little,
Quite a bit, or
Very much."|From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks.|Intent-to-treat population with improvement in bone pain||weeks||Full Range|Median
858362|NCT01311687|Secondary|Time to the First Hemoglobin Improvement|"Time to increased hemoglobin, defined as the time from randomization to at least one category improvement from Baseline in common terminology criteria for adverse events (CTCAE) grade for hemoglobin level. Hemoglobin categories are:
Normal;
CTCAE Grade 1: < lower limit of normal (LLN) to 10.0 g/dL;
CTCAE Grade 2: < 10.0 to <8.0 g/dL.
Participants with CTCAE Grade 3 anemia or worse at Baseline were excluded from the study."|From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks.|Intent-to-treat population with improvement in hemoglobin during the study||weeks||Full Range|Median
858363|NCT01311687|Secondary|Duration of Response|Duration of response (calculated for responders only) is defined as time from the initial documented response (partial response or better) to confirmed disease progression, based on IMWG criteria assessed by the Independent Response Adjudication Committee.|From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks.|Intent-to-treat responder population||weeks||95% Confidence Interval|Median
858364|NCT01311687|Secondary|Time to Response|"Time to response is calculated as the time from randomization to the initial documented response (partial response or better) based on IMWG criteria.
SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. If present at baseline a ≥ 50% reduction in size of soft tissue plasmacytomas is also required."|From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks.|Intent-to-treat responder population||weeks||Full Range|Median
858365|NCT01311687|Secondary|Time to Progression|"Time to progression (TTP) is calculated as the time from randomization to the first documented progression confirmed by a blinded, independent Response Adjudication Committee and based on the International Myeloma Working Group Uniform Response criteria (IMWG).
Progressive disease requires 1 of the following:
Increase of ≥ 25% from nadir in:
Serum M-component (absolute increase ≥ 0.5 g/dl);
Urine M-component (absolute increase ≥ 200 mg/24 hours);
Bone marrow plasma cell percentage (absolute % ≥ 10%);
Development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas;
Development of hypercalcemia (corrected serum calcium > 11.5 mg/dl) attributed solely to plasma cell proliferative disease."|From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks.|Intent-to-treat population||weeks||95% Confidence Interval|Median
858366|NCT01311687|Secondary|Percentage of Participants With Objective Response According to European Group for Blood and Marrow Transplantation (EBMT) Criteria|"Objective response defined as a best overall response of complete response (CR) or partial response (PR) based on the Independent Response Adjudication Committee:
CR requires all of the following:
Absence of original monoclonal paraprotein in serum and urine by immunofixation maintained at least 42 days.
<5% plasma cell in bone marrow aspirate and on bone marrow biopsy, if performed.
No increase in size or number of lytic bone lesions.
Disappearance of soft tissue plasmacytomas.
PR requires all of the following:
≥ 50% reduction in level of serum monoclonal paraprotein, maintained at least 42 days.
Reduction in 24-hour urinary light chain extraction by ≥ 90% or to < 200 mg, maintained at least 42 days.
For patients with non-secretory myeloma, ≥ 50% reduction in plasma cells in bone marrow aspirate and on biopsy, if performed, for at least 42 days.
≥ 50% reduction in the size of soft tissue plasmacytomas.
No increase in size or number of lytic bone lesions."|From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks.|Intent-to-treat population||percentage of participants|||Number
858410|NCT01245062|Secondary|PFS in BRAF V600E Mutation-positive Participants Without a History of Brain Metastases and Without Prior Chemotherapy as Assessed by the Investigator|PFS is defined as the time from the date of randomization to the first documented occurrence of PD or death. Investigator-assessed PFS was summarized per RECIST, Version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions, or the worsening of non-target lesions significant enough to require study treatment discontinuation.|Day 1 until the earliest date of disease progression or death due to any cause (average of 4.8 months)|Primary Efficacy Population. Only those participants without prior chemotherapy were analyzed.||Months||95% Confidence Interval|Median
858367|NCT01311687|Secondary|Percentage of Participants With an Objective Response According to International Myeloma Working Group (IMWG) Uniform Response Criteria|"Objective response is defined as a best overall response of stringent complete response (SCR), complete response (CR), very good partial response (VGPR) or partial response (PR) based on the Independent Response Adjudication Committee:
SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. In addition to the above, if present at baseline a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required."|From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks.|Intent-to-treat population||percentage of participants|||Number
858368|NCT01311687|Secondary|Overall Survival With a Later Cut-off Date|Overall survival is calculated as the time from randomization to death from any cause. Overall survival was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented.|From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up for survival was 93 weeks.|Intent-to-treat||weeks||95% Confidence Interval|Median
858369|NCT01311687|Secondary|Overall Survival|Overall survival is calculated as the time from randomization to death from any cause. Overall survival was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented.|From randomization until the data cut-off date of 07 September 2012. Maximum time on follow-up for survival was 70 weeks.|Intent-to-treat||weeks||95% Confidence Interval|Median
858370|NCT01311687|Secondary|Number of Participants With Adverse Events (AEs)|"An adverse event is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. A serious AE is any AE occurring at any dose that:
Results in death;
Is life-threatening;
Requires or prolongs existing inpatient hospitalization;
Results in persistent or significant disability/incapacity;
Is a congenital anomaly/birth defect;
Constitutes an important medical event.
The Investigator assessed the relationship of each AE to study drug and graded the severity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0):
Grade 1 = Mild (no limitation in activity or intervention required); Grade 2 = Moderate (some limitation in activity; no/minimal medical intervention required);-Grade 3 = Severe (marked limitation in activity; medical intervention required, hospitalization possible); Grade 4 = Life-threatening; Grade 5 = Death."|From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 01 March 2013. Maximum time on treatment was 93 weeks.|Safety population (all randomized participants who received at least one dose of study drug (either Pomalidomide or Dexamethasone)).||participants|||Number
858371|NCT01311687|Primary|Progression-free Survival (PFS)|"Progression-free survival was calculated as the time from randomization to disease progression as determined by the Independent Response Adjudication Committee based on the International Myeloma Working Group Uniform Response criteria (IMWG), or death on study, whichever occurred earlier.
Progressive disease requires 1 of the following:
Increase of ≥ 25% from nadir in:
Serum M-component (absolute increase ≥ 0.5 g/dl);
Urine M-component (absolute increase ≥ 200 mg/24 hours);
Bone marrow plasma cell percentage (absolute % ≥ 10%);
Development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas;
Development of hypercalcemia (corrected serum calcium > 11.5 mg/dl) attributed solely to plasma cell proliferative disease."|From randomization until the data cut-off date of 07 September 2012. Maximum duration of follow-up for PFS assessments was 57 weeks.|Intent-to-treat population||weeks||95% Confidence Interval|Median
858372|NCT01307891|Secondary|Progression-free Survival|Progression is defined using the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) as a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.|Baseline through 24 months|||months||95% Confidence Interval|Median
858373|NCT01307891|Secondary|Number of Participants With Serious Adverse Events|Patients will be assessed throughout the study for Grade 4 or 5 toxicities utilizing the Common Toxicity Criteria for Adverse Events (CTCAE) v4.0.|Baseline to 6 months|||Participants|||Count of Participants
858374|NCT01307891|Primary|Objective Response Rate|Patient response rates will be measured by the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI. Responses include the following: Complete Response (CR) disappearance of all target lesions; Partial Response (PR) at least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) best response from the start of treatment until disease progression.|Baseline to 6 months|||percentage of patients||95% Confidence Interval|Number
858382|NCT01264601|Secondary|Influence of Atopic Co-morbidities on Severe Reactivity to Vaccine as it Was Administered|"Rates of co-morbid allergic disease, size and magnitude of egg skin and ImmunoCAP tests, presence of other food allergy, and tolerance of baked egg will be assessed through a screening questionnaire and chart review, and compared between the groups to assess for any significant differences that may predict TIV tolerance."|6 months|Because no participants had systemic/severe reactivity, there were no participants who were TIV intolerant, and therefore no meaningful analysis of correlation of baseline characteristics to intolerance could be performed. All Baseline Characteristics collected for the original purpose of such correlation are reported in Baseline Characteristics.|||||
858383|NCT01264601|Primary|Categorical Reactivity to Vaccine as it Was Administered|"After randomization, group 1 will receive a 10%/90% (or 20%/80% for 0.25ml) graded challenge of the age appropriate TIV dose, separated by 30 minutes for observation. Group 2 will receive a first dose consisting of normal saline at a volume equal to 10% of their age appropriate dose, and the second dose will consist of their full age appropriate dose as the 90% equivalent, also separated by 30 minutes of observation. For children receiving a 0.25ml dose, a 20%/80% split will be used for ease of administration in drawing up the dose. All parties will report any adverse reactions occurring in the next 48 hours after vaccination that were not observed at the time of in office observation."|48 hours|||Participants|||Count of Participants
858384|NCT01247324|Secondary|Number of Participants With Anti-Drug Antibodies (ADAs) to Ocrelizumab|Number of participants positive for anti-drug antibodies (ADAs) to ocrelizumab is the number of post- baseline evaluable participants determined to have treatment-induced ADA or treatment-enhanced ADA during the study period.|Baseline up to week 96|Baseline evaluable participants with an ADA assay result from a baseline sample(s). The safety population included all participants who received any study drug. Here, n signifies the number of participants evaluable at the specified time points.||Participants|||Number
858385|NCT01247324|Secondary|Exposure to Ocrelizumab (Area Under the Concentration - Time Curve, AUC)|AUC represents total drug exposure for one dosing interval after the 4th dose.|Pre-infusion at Weeks 1, 24, 48, 72; and 30 minutes post-infusion at Week 72; at any time during Weeks 84 and 96|The pharmacokinetics (PK) population included all participants in the ocrelizumab group who had at least 1 measurable concentration value.||micrograms per milliliter*day||Standard Deviation|Mean
858386|NCT01247324|Secondary|Number of Participants With Adverse Events (AEs)|AEs included infusion related reactions (IRRs) and serious MS relapses, but excluded non-serious MS relapses. Serious Adverse Events (SAEs) included serious MS relapses and serious IRRs.|Baseline up to Week 96|The safety population included all participants who received any study drug.||Participants|||Number
858387|NCT01247324|Secondary|Percentage of Participants Who Have No Evidence of Disease Activity (NEDA) up to Week 96|NEDA was defined only for participants with a baseline EDSS score >=2.0. The EDSS scale ranges from 0 (normal neurological exam) to 10 (death due to multiple sclerosis). Participants who completed the 96- week treatment period were considered as having evidence of disease activity if at least one protocol- defined relapse (PDR), a confirmed disability progression (CDP) event or at least one MRI scan showing MRI activity (defined as Gd-enhancing T1 lesions, or new or enlarging T2 lesions) was reported during the 96-week treatment period, otherwise the participant was considered as having NEDA.|Week 96|ITT population included all randomized participants in the study. Here, number of participants analyzed signifies number of participants who were evaluable for this outcome measure.||percentage of participants||95% Confidence Interval|Number
858388|NCT01247324|Secondary|Change From Baseline in Short Form Health Survey-36 (SF-36) Physical Component Summary (PCS) Score at Week 96|The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and mental composite t-score (MCS). The range for all 8 domains as well as for the composite t- scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.|Baseline, Week 96|Descriptive statistics at baseline include participants with assessment at baseline and at least one post- baseline value. ITT population included all randomized participants in the study. Here, n signifies the number of participants evaluable at specified time points.||t-score||Standard Error|Mean
858389|NCT01247324|Secondary|Percent Change in Brain Volume as Detected by Brain Magnetic Resonance Imaging (MRI) From Week 24 to Week 96|"Brain volume was recorded as an absolute normalized value at the baseline visit then recorded at subsequent visits as a percentage change relative to the absolute value at the baseline visit. Therefore, brain volume at Week 24 was calculated as the brain volume at the baseline visit multiplied by 1 + ([percentage change in brain volume from baseline visit to Week 24]/100). Estimates are from analysis based on mixed-effect model of repeated measures (MMRM) using unstructured covariance matrix: Percentage Change = Brain Volume at Week 24 + Geographical Region (US vs. ROW) + Baseline EDSS (< 4.0 vs. >= 4.0) + Week + Treatment + Treatment*Week (repeated values over Week) + Brain Volume at Week 24*Week."|From Week 24 up to Week 96|ITT population included all randomized participants in the study. Here, number of participants analyzed signifies number of participants who were evaluable for this outcome measure.||percent change||Standard Error|Mean
858439|NCT01186692|Secondary|Changes in NYHA Functional Classification|Change in NYHA functional class from pre-implant to 6 month post-implant|6 Months|The implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours. Of this population those with evaluable paired NYHA data were included in the analysis.||participants|||Number
858390|NCT01247324|Secondary|Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Score to Week 96|MSFC score consists of: A) Timed 25-Foot walk; B) 9-Hole Peg Test (9-HPT); and C) Paced Auditory Serial Addition Test (PASAT-3 version). The MSFCS is based on the concept that scores for these three dimensions (arm, leg, and cognitive function) are combined to create a single score (the MSFC) that can be used to detect change over time in a group of participants with MS. Since the three primary measures differ in what they actually measure, a common composite score for the three different measures i.e., Z- score was selected for the purpose. MSFC Score = {Z arm, average + Z leg, average + Z cognitive} / 3.0. The results from each of these three tests are transformed into Z-scores and averaged to yield a composite score for each participant at each time point. A score of +1 indicates that, on average, an individual scored 1 standard deviation (SD) better than the reference population and a score of -1 indicates that an individual scored 1 SD worse than the reference population.|Baseline, Week 96|ITT population included all randomized participants in the study. Here, n signifies the number of participants evaluable at specified time points.||Z-score||Standard Error|Mean
858391|NCT01247324|Secondary|Number of T1 Hypointense Lesions During the Double-Blind Treatment|The total number of new T1-Hypo-Intense Lesions (Chronic Black Holes) for all participants in the treatment group was calculated as the sum of the individual number of new lesions at Weeks 24, 48, and 96.|Baseline up to Week 96|ITT population included all randomized participants in the study.||lesions|||Number
858392|NCT01247324|Secondary|Time to Onset of Confirmed Disability Progression (CDP) for at Least 24 Weeks During the Double-Blind Treatment Period|Disability progression was defined as an increase in the Expanded Disability Status Scale (EDSS) score of: A) >=1.0 point from the baseline EDSS score when the baseline score was less than or equal to (<=) 5.5 B) >=0.5 point from the baseline EDSS score when the baseline score was >5.5 The EDSS scale ranges from 0 (normal neurological exam) to 10 (death due to multiple sclerosis). This outcome measure was considered confirmatory only when results of both studies WA21092 and WA21093 were combined. Disability progression was considered confirmed when the increase in the EDSS was confirmed at a regularly scheduled visit at least 24 weeks after the initial documentation of neurological worsening. Participants who had initial disability progression with no confirmatory EDSS assessment and who were on treatment at time of clinical cut-off date were censored at the date of their last EDSS assessment.|Week 108|ITT population included all randomized participants in the study.||weeks||Full Range|Median
858393|NCT01247324|Secondary|Percentage of Participants With Confirmed Disability Improvement (CDI) for at Least 12 Weeks|Disability improvement was assessed only for the subgroup of participants with a baseline EDSS score of >= 2.0. It was defined as a reduction in EDSS score of: A) >=1.0 from the baseline EDSS score when the baseline score was >=2 and <=5.5 B) >= 0.5 when the baseline EDSS score > 5.5. The EDSS scale ranges from 0 (normal neurological exam) to 10 (death due to multiple sclerosis). This outcome measure was considered confirmatory only when results of both studies WA21092 and WA21093 were combined.|Week 96|ITT population included all randomized participants in the study. Here, number of participants analyzed signifies number of participants who were evaluable for this outcome measure.||percentage of participants||95% Confidence Interval|Number
858394|NCT01247324|Secondary|Number of New, and/or Enlarging T2 Hyperintense Lesions as Detected by Brain Magnetic Resonance Imaging (MRI) During the Double Blind Treatment|The total number of new and/or enlarging T2 lesions for all participants in the treatment group was calculated as the sum of the individual number of lesions at Weeks 24, 48, and 96.|Baseline up to Week 96|ITT population included all randomized participants in the study.||lesions|||Number
858395|NCT01247324|Secondary|Number of T1 Gadolinium (Gd)-Enhancing Lesions as Detected by Brain Magnetic Resonance Imaging (MRI) During the Double-Blind Treatment|The total number of T1 gadolinium-enhancing lesions for all participants in the treatment group was calculated as the sum of the individual number of lesions at Weeks 24, 48, and 96.|Baseline up to Week 96|ITT population included all randomized participants in the study.||lesions|||Number
858396|NCT01247324|Secondary|Time to Onset of Confirmed Disability Progression (CDP) for at Least 12 Weeks During the Double-Blind Treatment Period|Disability progression was defined as an increase in the Expanded Disability Status Scale (EDSS) score of: A) >=1.0 point from the baseline EDSS score when the baseline score was less than or equal to (<=) 5.5 B) >=0.5 point from the baseline EDSS score when the baseline score was >5.5 The EDSS scale ranges from 0 (normal neurological exam) to 10 (death due to multiple sclerosis). This outcome measure was considered confirmatory only when results of both studies WA21092 and WA21093 were combined. Disability progression was considered confirmed when the increase in the EDSS was confirmed at a regularly scheduled visit at least 12 weeks after the initial documentation of neurological worsening. EDSS assessment and who were on treatment at time of clinical cut-off date were censored at the date of their last EDSS assessment.|Week 108|ITT population included all randomized participants in the study.||weeks||Full Range|Median
858397|NCT01247324|Primary|Annualized Relapse Rate (ARR) in Participants With Relapsing Multiple Sclerosis (MS) at 96 Weeks|ARR was protocol-defined and calculated as the total number of relapses for all participants in the treatment group divided by the total participant-years of exposure to that treatment.|Week 96|Intent-to-treat (ITT) population included all randomized participants in the study.||relapses/participant year of treatment||95% Confidence Interval|Number
858398|NCT01245062|Secondary|PFS Following Cross-over to Trametinib as Assessed by the Investigator|PFS is defined as the time from the first dose of cross-over therapy to the first documented occurrence of PD or death. PFS was summarized per RECIST, Version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions, or the worsening of non-target lesions significant enough to require study treatment discontinuation.|Day 1 of cross-over therapy until the earliest date of disease progression or death due to any cause (average of 2.72 months)|Cross-over Population||Months||95% Confidence Interval|Median
858411|NCT01245062|Secondary|Progression-free Survival in All Participants|PFS is defined as the time from the date of randomization to the first documented occurrence of PD or death. Investigator-assessed and BRIC-assessed PFS were summarized per RECIST, Version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions, or the worsening of non-target lesions significant enough to require study treatment discontinuation.|Day 1 until the earliest date of disease progression or death due to any cause (average of 4.8 months)|ITT Population: all randomized participants regardless of whether or not treatment was administered||Months||95% Confidence Interval|Median
858399|NCT01245062|Secondary|DR for All Responders (CR or PR) Following Cross-over to Trametinib as Assessed by the Investigator|DR is defined as the time from the first documented evidence of CR (disappearance of all extranodal lesions. Any pathological lymph node must be less than 10 mm in the short axis) or PR (at least a 30% decrease in the sum of the diameters of target lesions) until PD or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions, or the worsening of non-target lesions significant enough to require study treatment discontinuation. DR data were summarized per RECIST, Version 1.1.|Day 1 of cross-over therapy until the earliest date of disease progression or death due to any cause (average of 2.72 months)|Cross-over Population. Only those participants with confirmed response (CR and PR) were analyzed.||Months||95% Confidence Interval|Median
858400|NCT01245062|Secondary|DR for All Confirmed Responders (CR or PR) as Assessed by the Investigator or Independent Review|DR is defined as thetime from the first documented evidence of CR (disappearance of all target lesions. Any pathological lymph node must be less than 10 mm in the short axis) or PR (at least a 30% decrease in the sum of the diameters of target lesions) until PD or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions, or the worsening of non-target lesions significant enough to require study treatment discontinuation. DR for the INVA and INDA response data was summarized per RECIST, Version 1.1.|Day 1 until the earliest date of disease progression or death due to any cause (average of 4.8 months)|"ITT Population. Only those participants with confirmed response (CR and PR) were analyzed. The n in the category title reflects the number of participants with a confirmed response assessed by the Investigator and by Independent Review. The same participants were not necessarily assessed by both."||Months||95% Confidence Interval|Median
858401|NCT01245062|Secondary|Duration of Response (DR) for All BRAF V600E Mutation-positive Participants Without a Prior History of Brain Metastases Classifed as Confirmed Responders (CR or PR) as Assessed by the Investigator and Independent Review|DR is defined as the time from the first documented evidence of CR (disappearance of all target lesions. Any pathological lymph node must be less than 10 mm in the short axis) or PR (at least a 30% decrease in the sum of the diameters of target lesions) until PD (at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions, or the worsening of non-target lesions significant enough to require study treatment discontinuation) or death due to any cause. DR for the investigator-assessed (INVA) and independently-assessed (INDA) response data were summarized per RECIST, Version 1.1.|Day 1 until the earliest date of disease progression or death due to any cause (average of 4.8 months)|"Primary Efficacy Population. Only those participants (par.) with a confirmed response (CR and PR) were analyzed. The n in the category title reflects the par. assessed by the Investigator and by Independent Review; the same par. were not necessarily assessed by both."||Months||95% Confidence Interval|Median
858402|NCT01245062|Secondary|Number of Participants With OR Following Cross-over to Trametinib|OR is defined as the number of participants with evidence of CR (disappearance of all target lesions. Any pathological lymph node must be less than 10 millimeters in the short axis) or PR (at least a 30% decrease in the sum of the diameters of target lesions) evaluated by the Investigator in participants following cross-over to Trametinib. The evaluation was carried out by the Investigator per RECIST, Version 1.1.|Day 1 of cross-over therapy until the earliest date of disease progression or death due to any cause (average of 2.72 months)|Cross-over Population: the subset of participants who were randomized to CT and who elected to cross-over to Trametinib following disease progression on CT. Only participants who received at least one dose of Trametinib were included in this population.||Participants|||Number
858403|NCT01245062|Secondary|Number of BRAF V600K Mutation-positive Participants Classified as Confirmed Responders (CR and PR) as Assessed by the Investigator|OR is defined as the number of participants with evidence of complete response (CR; disappearance of all extranodal lesions. Any pathological lymph node must be less than 10 mm in the short axis) or partial response (PR: at least a 30% decrease in the sum of the diameters of target lesions) evaluated by the Investigator per RECIST, Version 1.1.|Day 1 until the earliest date of disease progression or death due to any cause (average of 4.8 months)|ITT Population: only those participants withV600K mutation-positive melanoma were assessed.||Participants|||Number
858404|NCT01245062|Secondary|Number of BRAF V600E Mutation-positive Participants Classified as Confirmed Responders (CR and PR) as Assessed by the Investigator|OR is defined as the number of participants with evidence of complete response (CR; disappearance of all extranodal lesions. Any pathological lymph node must be less than 10 mm in the short axis) or partial response (PR: at least a 30% decrease in the sum of the diameters of target lesions) evaluated by the Investigator per RECIST, Version 1.1.|Day 1 until the earliest date of disease progression or death due to any cause (average of 4.8 months)|ITT Population: only those participants withV600E mutation-positive melanoma were assessed.||Participants|||Number
858405|NCT01245062|Secondary|Number of Participants With OR as Assessed by the Investigator and Independent Review|OR is defined as the number of participants with evidence of complete response (CR; disappearance of all target lesions. Any pathological lymph node must be less than 10 mm in the short axis) or partial response (PR: at least a 30% decrease in the sum of the diameters of target lesions) evaluated by the Investigator and an independent review per RECIST, Version 1.1.|Day 1 until the earliest date of disease progression or death due to any cause (average of 4.8 months)|ITT Population||Participants|||Number
858406|NCT01245062|Secondary|Number of BRAF V600E Mutation-positive Participants Without a History of Brain Metastases With Overall Response (OR) as Assessed by the Investigator and Independent Review|OR is defined as the number of participants with evidence of complete response (CR; disappearance of all target lesions. Any pathological lymph node must be less than 10 mm in the short axis) or partial response (PR: at least a 30% decrease in the sum of the diameters of target lesions) evaluated by the Investigator and an independent review per RECIST, Version 1.1.|Day 1 until the earliest date of disease progression or death due to any cause (average of 4.8 months)|Primary Efficacy Population||participants|||Number
858407|NCT01245062|Secondary|Overall Survival in BRAF V600E Mutation-positive Participants Without a History of Brain Metastases|Overall survival was defined as the time from the date of randomization to the date of death due to any cause.|Day 1 until death due to any cause (average of 4.8 months)|Primary Efficacy Population||Months||95% Confidence Interval|Median
858412|NCT01245062|Primary|Progression-free Survival in BRAF V600E Mutation-positive Participants Without a History of Brain Metastases as Assessed by the Investigator and Independent Review|Progression-free survival (PFS) is defined as the time from randomization to the first documented occurrence of disease progression or death. PFS for investigator-assessed and blinded, independent, central review committee (BRIC)-assessed responses was summarized per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1, which is a set of published rules defining when cancer patients improve (respond), stay the same (stabilize), or worsen (progress) during treatment. Disease progression is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 millimeters (mm) or the appearance of at least 1 new lesion, or the worsening of non-target lesions significant enough to require study treatment discontinuation.|Day 1 until the earliest date of disease progression or death due to any cause (average of 4.8 months)|Primary Efficacy Population: All participants with BRAF V600E mutation-positive melanoma without a history of brain metastases||Months||95% Confidence Interval|Median
858413|NCT01243177|Primary|Number of Subjects With at Least One Treatment-emergent Serious Adverse Event (SAE) During the Treatment Phase (up to 113 Weeks)|"An Adverse Event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
A Serious Adverse Event must meet 1 or more predefined criteria like death, life-threatening, etc. Treatment-emergent AEs were defined as AEs that started on or after the date of first dose of study medication and within 30 days following the date of final study medication administration, or AEs whose intensity worsened on or after the date of first dose of study medication and within 30 days following the date of last dose."|Duration of the Treatment Phase (up to 113 weeks)|Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.||Participants|||Number
858414|NCT01243177|Secondary|Proportion of Subjects Remaining Seizure Free for 12 Consecutive Months (52 Consecutive Weeks) Following Stabilization at the Last Evaluated Dose for Each Subject|The proportion of subjects remaining seizure free for 12 months (52 weeks) was estimated using Kaplan-Meier methods.|12 consecutive months of treatment following stabilization at the last evaluated dose for each subject|Full Analysis Set (FAS), consisting of all randomized subjects who took at least 1 dose of study medication.||percentage of subjects||95% Confidence Interval|Number
858415|NCT01243177|Primary|Number of Subjects Who Withdraw From the Study Due to a Treatment-emergent Adverse Event (AE) During the Treatment Phase (up to 113 Weeks)|An Adverse Event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Treatment-emergent AEs were defined as AEs that started on or after the date of first dose of study medication and within 30 days following the date of final study medication administration, or AEs whose intensity worsened on or after the date of first dose of study medication and within 30 days following the date of last dose.|Duration of the Treatment Phase (up to 113 weeks)|Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.||Participants|||Number
858416|NCT01243177|Primary|Number of Subjects With at Least One Treatment-emergent Adverse Event (AE) During the Treatment Phase (up to 113 Weeks)|An Adverse Event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Treatment-emergent AEs were defined as AEs that started on or after the date of first dose of study medication and within 30 days following the date of final study medication administration, or AEs whose intensity worsened on or after the date of first dose of study medication and within 30 days following the date of last dose.|Duration of the Treatment Phase (up to 113 weeks)|Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.||Participants|||Number
858417|NCT01243177|Primary|Proportion of Subjects in the Per Protocol Set (PPS) Remaining Seizure Free for 6 Consecutive Months (26 Consecutive Weeks) of Treatment Following Stabilization at the Last Evaluated Dose for Each Subject|The proportion of subjects remaining seizure free for 6 months (26 weeks) was estimated using Kaplan-Meier methods.|6 consecutive months (26 consecutive weeks) of treatment|The Per Protocol Set (PPS) was defined as containing all subjects in the Full Analysis Set (FAS) who did not have any important protocol deviations determined to impact the interpretation of primary efficacy.||percentage of subjects||95% Confidence Interval|Number
858418|NCT01243177|Primary|Proportion of Subjects in the Full Analysis Set (FAS) Remaining Seizure Free for 6 Consecutive Months (26 Consecutive Weeks) of Treatment Following Stabilization at the Last Evaluated Dose for Each Subject|The proportion of subjects remaining seizure free for 6 months (26 weeks) was estimated using Kaplan-Meier methods.|6 consecutive months (26 consecutive weeks) of treatment following stabilization at the last evaluated dose for each subject|Full Analysis Set (FAS), consisting of all randomized subjects who took at least 1 dose of study medication.||percentage of subjects||95% Confidence Interval|Number
858419|NCT01240902|Secondary|Prosthetic Valve Dysfunction (PVD)|"PVD was defined according to VARC I using the Core Lab Echocardiography assessments including aortic regurgitation (AR) and aortic stenosis (AS) evaluations. Total AR reported as moderate or severe was considered PVD. AS was defined as significant stenosis and considered PVD if one of the following was met:
Peak velocity >4 m/s
Mean gradient >35 mmHg
EOA < 0.8 cm2
TVIV1 / TVIV2 < 0.25"|30 day, 6 month, 1 year, 2 year|Participant Population= Consisted of all subjects with a valve implanted.||percentage of participants|||Number
858420|NCT01240902|Secondary|Procedural Success|"Medtronic CoreValve® System subjects only.
Defined as device success and absence of in-hospital MACCE."|Number of days from admission to discharge|Participant Population= Consisted of all subjects with a TAVR index procedure who were evaluable for procedural success.||percentage of participants|||Number
858421|NCT01240902|Secondary|Device Success|"Medtronic CoreValve® System subjects only.
Defined as:
Successful vascular access, delivery and deployment of the device, and successful retrieval of the delivery system,
Correct position of the device in the proper anatomical location (placement in the annulus with no impedance on device function),
Intended performance of the prosthetic valve (aortic valve area > 1.2 cm2 for 26, 29 and 31mm valves, ≥ 0.9 cm2 for 23mm valve (by echocardiography using the continuity equation) and mean aortic valve gradient < 20 mmHg or peak velocity < 3 m/sec, without moderate or severe prosthetic valve aortic regurgitation)
Only one valve implanted in the proper anatomical location"|Number of days from admission to discharge|Participant Population= Consisted of all subjects with a TAVR index procedure who were evaluable for device success.||percentage of participants|||Number
858422|NCT01240902|Secondary|Length of Index Procedure Hospital Stay||Number of days from admission to discharge|Participant Population= Consisted of all subjects with an attempted implant procedure.||days||Standard Deviation|Mean
858423|NCT01240902|Secondary|Index Procedure Related MAEs||Procedure|Participant Population= Consisted of all subjects with an attempted implant procedure.||percentage of participants|||Number
858424|NCT01240902|Secondary|Strokes and Transient Ischemic Attacks (TIAs)|Strokes (of any severity) and TIAs|30 day, 6 month, 1 year, 2 year|Participant Population= Consisted of all subjects with an attempted implant procedure.||percentage of participants, Kaplan-Meier|||Number
858425|NCT01240902|Secondary|Cardiovascular Deaths and Valve Related Deaths||30 day, 6 month, 1 year, 2 year|Participant Population= Consisted of all subjects with an attempted implant procedure.||percentage of participants, Kaplan-Meier|||Number
858426|NCT01240902|Secondary|Aortic Valve Hospitalizations||30 day, 6 month, 1 year, 2 year|Participant Population= Consisted of all subjects with an attempted implant procedure||percentage of participants, Kaplan-Meier|||Number
858427|NCT01240902|Secondary|Echocardiographic Assessment of Valve Performance|"Using the following measure:
- Degree of Aortic Valve Regurgitation (Transvalvular and Paravalvular)"|30 day, 6 month, 1 year, 2 year|Participant Population= Consisted of all subjects with a valve implanted.||percentage of participants|||Number
858428|NCT01240902|Secondary|Echocardiographic Assessment of Valve Performance|"Using the following measures:
- Transvalvular Mean Gradient"|30 day, 6 month, 1 year, 2 year|Participant Population= Consisted of all subjects with a valve implanted.||mmHg||Standard Deviation|Mean
858429|NCT01240902|Secondary|Echocardiographic Assessment of Valve Performance|"Using the following measures:
- Effective Orifice Area (EOA)"|30 day, 6 month, 1 year, 2 year|Participant Population= Consisted of all subjects with a valve implanted.||cm^2||Standard Deviation|Mean
858430|NCT01240902|Secondary|Quality of Life (QoL) Change|"QoL summary score change from baseline using the following measures:
Kansas City Cardiomyopathy Questionnaire (KCCQ): Quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
12 Item Short Form Health Survey (SF-12): Measures functional health and well-being. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
European QoL (EQ-5D): Measures 5 domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that can be converted to utilities using an algorithm. Utilities range from 0 to 1, with 1 representing perfect health, and 0 corresponding to the worst imaginable health state."|30 day, 6 month, 1 year, 2 year|Participant Population= Consisted of all subjects with an attempted implant procedure.||units on a scale||Standard Deviation|Mean
858431|NCT01240902|Secondary|Ratio of Days Alive Out of Hospital Versus Total Days Alive||1 year|Participant Population= Consisted of all subjects with an attempted implant procedure.||ratio of days alive and out of hospital||Standard Deviation|Mean
858432|NCT01240902|Secondary|Change in Distance Walked During 6-Minute Walk Test (6MWT)|Change in distance walked during 6MWT from baseline|30 day, 1 year|Participant Population= Consisted of all subjects with an attempted implant procedure.||meters||Standard Deviation|Mean
858433|NCT01240902|Secondary|Change in NYHA Class|"Change from baseline (continuous variable). A positive number corresponds to NYHA worsening; a negative number corresponds to NYHA improvement.
New York Heart Association (NYHA) Classification:
Class I: Subjects with cardiac disease but without resulting limitations of physical activity.
Class I: Subjects with cardiac disease resulting in slight limitation of physical activity.
Class III: Subjects with cardiac disease resulting in marked limitation of physical activity.
Class IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort."|30 day, 6 month, 1 year, 2 year|Participant Population= Consisted of all subjects with an attempted implant procedure.||average classification level change||Standard Deviation|Mean
858434|NCT01240902|Secondary|Conduction Disturbance Requiring Permanent Pacemaker Implantation||30 day, 6 month, 1 year, 2 year|Participant Population= Consisted of all subjects with an attempted implant procedure.||percentage of participants, Kaplan-Meier|||Number
858435|NCT01240902|Secondary|Major Adverse Events (MAEs)|"MAEs Include:
MACCE
Acute Kidney Injury
Cardiac Tamponade
Prosthetic Valve Dysfunction
Cardiogenic Shock
Valve Endocarditis
Life-Threatening, Disabling or Major Bleeding
Major Vascular Complication
Cardiac Perforation
Device Migration/Valve Embolism"|30 day, 6 month, 1 year, 2 year|Participant Population= Consisted of all subjects with an attempted implant procedure.||percentage of participants, Kaplan-Meier|||Number
858436|NCT01240902|Secondary|The Occurrence of Individual MACCE Components|"Individual MACCE Components Include:
All Cause Mortality
MI
All stroke
Reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)"|30 day, 6 month, 1 year, 2 year|Participant Population= Consisted of all subjects with an attempted implant procedure.||percentage of participants, Kaplan-Meier|||Number
858437|NCT01240902|Secondary|Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)|"MACCE is defined as a composite of:
All Cause Mortality
Myocardial infarction (MI)
All Stroke
Reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)"|30 day, 6 month, 1 year, 2 year|Participant Population= Consisted of all subjects with an attempted implant procedure.||percentage of participants, Kaplan-Meier|||Number
858438|NCT01240902|Primary|Extreme Risk: All-cause Death or Major Stroke; High Risk Surgical: All-cause Mortality|All-cause Death or Major Stroke (Extreme Risk- Medtronic CoreValve® System); All-cause Mortality (High Risk Surgical- Medtronic CoreValve® System vs. Surgical Valve)|1 year|Participant Population= Consisted of all subjects with an attempted implant procedure.||percentage of participants, Kaplan-Meier|||Number
858440|NCT01186692|Secondary|Serious Device-related Adverse Events|A device-related event is defined as an event that is associated with the TPV by the chronology or physiology and was caused by the the TPV (e.g. embolization of the TPV and any adverse events which follow).|6 months|The implanted cohort consists of all subjects who underwent catheterization and a Melody TPV was implanted.||percentage of patients|||Number
858441|NCT01186692|Secondary|Serious Procedural Adverse Events|A procedure-related event is defined as an event that is associated with the implant procedure by the chronology or physiology and was caused by the implant procedure (e.g. rupture of the conduit or damage to an intra-cardiac or intravascular structure by the delivery system).|6 Months|The catheterized cohort consists of all subjects who underwent catheterization for possible implantation of the Melody TPV.||percentage of patients|||Number
858442|NCT01186692|Secondary|Procedural Success|"Procedural success is defined as a composite of the following:
The TPV is fixated within the desired location, and
The RV-PA peak-to-peak gradient measured in the catheterization lab after TPV implantation is less than 35 mmHg, and
There is no more than trivial pulmonary regurgitation by angiography
The subject is free from explantation of the TPV at 24 hours post-implant"|6 Months|The attempted implant cohort consists of all subjects who underwent catheterization and a Melody TPV implantation was attempted (Melody TPV valve opened).||percentage of patients|||Number
858443|NCT01186692|Primary|Acceptable TPV Hemodynamic Function at Six Months After Successful TPV Implantation|"Acceptable TPV hemodynamic function at six months after successful TPV implantation is determined as a composite of the following:
Mean RVOT gradient is less than or equal to 30 mmHg as measured by CW Doppler, and
Severity of pulmonary regurgitation is less than moderate by Doppler echocardiography, and
Free from RVOT conduit reoperation or catheter re-intervention at six months after TPV implantation.
The endpoint is defined as the percentage of subjects with acceptable TPV hemodynamic function at six months after Melody valve implantation."|6 months|The implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours. Of this population those with evaluable echo data at 6 months post implant were included in the analysis.||percentage of patients||95% Confidence Interval|Number
858444|NCT01144455|Primary|Progression-free Survival (PFS)|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first|||days||95% Confidence Interval|Median
858461|NCT01129245|Secondary|Change in Luteal Phase Progesterone Levels|progesterone levels during study|completion of study (1 year)||||||
858462|NCT01129245|Primary|Menstrual Length When Taken After Ovulation: Extended Luteal Phase|average menstrual cycle length in days during active drug exposure|Completion of study (1 year)|||days||Standard Deviation|Mean
858468|NCT01071512|Secondary|Change Over Time in Normalized Hippocampal Volume|Measured on MRI scan|Baseline, 48 weeks, 96 weeks|Summary statistics are based on subjects completing all treatment||mL||Standard Deviation|Mean
858469|NCT01071512|Secondary|Change Over Time in Normalized Thalamic Volume|Measured on MRI scan|Baseline, 48 weeks, 96 weeks|Summary statistics are based on subjects completing all treatment||mL||Standard Deviation|Mean
858470|NCT01071512|Secondary|Change Over Time in Brain Parenchymal Fraction|Measured based on MRI scan on a 3T Phillips scanner. This is a measure of brain atrophy (i.e., brain volume loss) with lower values indicating greater atrophy (possible range 0-1).|Baseline, 48 weeks, 96 weeks|Summary statistics are based on subjects completing treatment||units on a scale||Standard Deviation|Mean
858471|NCT01071512|Secondary|Change Over Time in Retinal Nerve Fiber Layer Thickness|Retinal Nerve Fiber Layer (RNFL) thickness was measured using spectral domain OCT scans by a trained technician. Scans were performed without pupil dilation.|Baseline, 24, 48, 72, and 96 weeks|Summary statistics are provided based on subjects completing all treatment||micrometer||Standard Deviation|Mean
858472|NCT01071512|Primary|Change in Cognitive Function Over Time|Cognitive function was assessed using the oral version of the Symbol Digit Modalities Test (SDMT). The number of correct responses in 90 seconds was recorded (possible range 0-110). For analysis, SDMT scores were converted to z-scores using published age and education based norms. A negative z-score indicates a SDMT score below the mean based on the age and education based norms, for example a z-score of -2 = 2 standard deviations below the mean; a positive z-score indicating a score above the mean. Higher scores indicate better cognitive function.|Baseline, 48 weeks, 96 weeks|Summary statistics are based on the 15 subjects who completed treatment||units on a scale||Standard Deviation|Mean
858479|NCT01004003|Secondary|Overall Survival|Overall survival was defined as the duration from date of randomisation to the date of death.|From randomization until data cut-off (15 July 2014); Up to 1031 days|Treated set, only phase II participants||months||Inter-Quartile Range|Median
858480|NCT01004003|Secondary|Progression Free Survival (PFS)|PFS by RECIST 1.0 was defined as the duration from date of randomisation to date of progression or death, whichever occurred earlier, based on central independent review.|From randomization until data cut-off (15 July 2014); Up to 1031 days|Treated set, only phase II participants||months||Inter-Quartile Range|Median
858481|NCT01004003|Secondary|Objective Tumour Response by RECIST|"Objective RECIST 1.0 tumour response was defined as Complete Response (CR) or Partial Response (PR) and was derived from the patient's best objective RECIST 1.0 response based on central independent review.
95% Confidence Interval presented below are computed by Clopper and Pearson method."|From randomization until data cut-off (15 July 2014); Up to 1031 days|Treated set, phase II participants only||percentage of participants||95% Confidence Interval|Number
858482|NCT01004003|Secondary|Incidence of Dose Limiting Toxicity in Phase I|Number of patients with dose limiting toxicity are presented|4 weeks|Treated set (Phase I patients from the dose escalation part that were not replaced for MTD determination).||participants|||Number
858483|NCT01004003|Primary|Time to Progression (TTP) in Phase II|TTP according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.0 criteria based on central independent review. TTP RECIST 1.0 was defined as the time from randomisation to disease progression according to RECIST 1.0.|From randomization until data cut-off (15 July 2014); Up to 1031 days|Treated set, only phase II participants.||months||Inter-Quartile Range|Median
858484|NCT01004003|Primary|Maximum Tolerated Dose in Phase I|The MTD was defined as the highest dose studied for which the incidence of dose limiting toxicities (DLTs) was 0/3 or less than 2/6 patients during the first treatment course.|4 weeks|Treated set which included all patients who received at least one single dose of trial medication, including phase I patients from the dose escalation part that were not replaced for MTD determination.||mg bid|||Number
858500|NCT00937937|Secondary|Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs|Adverse Events (AEs) are reported by CTCAE Version 3.0. Only adverse events that are possibly, probably or definitely related to study drug are reported. The outcome measure here is different from Serious Adverse Event, whose definition could be more strict and specific. The number of patients who suffers the certain adverse event listed here could be larger than the number listed in following serious adverse event.|Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.|Eligible patients who had received the protocol treatments were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.||Participants|||Number
858621|NCT00731731|Secondary|Incidence of Adverse Events, Based on CTC (Common Toxicity Criteria) Severity Grade|Safety variables will be summarized by descriptive statistics. Adverse Events (AEs) that occur will be reported for each phase and dose level and described in terms of incidence and severity. Parameters will be described based on the CTC severity grading. Distribution by CTC severity grade and clinical relevance will be given.|Up to 5 years|||participants evaluable for toxicity|||Number
858501|NCT00937937|Secondary|Response Rate (Confirmed and Unconfirmed Complete and Partial Responses) Assessed by RECIST|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Disease assessments for response were performed every 6 weeks, up to 3 years|||percentage of participants||95% Confidence Interval|Mean
858502|NCT00937937|Secondary|Progression-free Survival Assessed by Response Evaluation Criteria for Solid Tumors (RECIST)|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The duration from the date of randomization to the date of first documentation of progressive disease, symptomatic deterioration, or death dure to any cause.|Disease assessment was performed every 6 weeks, up to 3 years.|||months||95% Confidence Interval|Median
858503|NCT00937937|Primary|Overall Survival|From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Weekly, up to 3 years|||months||95% Confidence Interval|Median
858504|NCT00931632|Secondary|Severity of Bronchopulmonary Dysplasia||36 weeks|Number of subjects within the Intent-to-treat population with available data||Participants|||Count of Participants
858505|NCT00931632|Secondary|Number of Days of Oxygen Use||Birth to hospital discharge|Number of subjects within the Intent-to-treat population with available data||Days||Standard Deviation|Mean
858506|NCT00931632|Secondary|Systemic Use of Postnatal Corticosteroids for Any Medical Reason||Start of drug through hospital discharge|Intent-to-treat population||Participants|||Count of Participants
858507|NCT00931632|Secondary|Use of Postnatal Corticosteroids for Any Medical Reason||Start of drug through hospital discharge|Intent-to-treat population||Participants|||Count of Participants
858508|NCT00931632|Secondary|Use of Postnatal Corticosteroids for Bronchopulmonary Dysplasia||Start of drug through hospital discharge|Intent-to-treat population||Participants|||Count of Participants
858509|NCT00931632|Secondary|Length of Birth Hospitalization||Baseline to hospital discharge|Number of subjects within the Intent-to-treat population with available data||Days||Standard Deviation|Mean
858510|NCT00931632|Secondary|Days of Airway Pressure Support - Intent-to-treat Population|Airway pressure support includes conventional mechanical ventilation, conventional, high frequency oscillatory ventilation, jet, continuous positive airway pressure, and other.|during birth hospitalization|||Days||Standard Deviation|Mean
858511|NCT00931632|Primary|Survival Without BPD at 36 Weeks||Baseline, 36 weeks PMA|Subjects with missing primary outcome or who crossed over to open-label iNO during the blinded treatment period were considered as failures||participants|||Number
858604|NCT00811317|Secondary|Percentage of Time Spent Within 70-180 mg/dl||24 hours|||percentage of time||Standard Deviation|Mean
858605|NCT00811317|Primary|Average Blood Glucose Over the Closed-loop Control Period||24 hours|||mg/dl||Standard Deviation|Mean
858569|NCT00857220|Secondary|Change From Baseline in Pediatric Quality of Life Scale|The SF-10™ Health Survey for Children is a 10-item care-giver completed assessment designed to measure children's health-related quality of life. The scale asked questions about the child's physical wellness, feelings, behavior, and activities at school and with family and friends. The SF-10 physical and psychosocial summary measures were scored such that higher scores indicated more favorable functioning. The Physical Summary Score is computed by summing values for questions 1, 2a, 2b, 3 and 5 and standardizing scores by normalizing to a total possible score of 0-100 with higher scores representing more positive indications. The Psychosocial Summary Score is computed by summing questions 4, 6, 7, 8, and 9 and standardizing scores by normalizing to a total possible score of 0-100 with higher scores representing more positive indications.|Baseline and 12 Months (from the 1st dose to the end of study)|Intent to treat population||units on a scale||Standard Deviation|Mean
858570|NCT00857220|Secondary|Change From Baseline at Month 12 in Subjective Total Sleep Time (TST).|The sleep questionnaire, a Sponsor produced questionnaire used in previous eszopiclone studies, asked the subject or parent/guardian to report information about the subject’s sleep and daytime functioning since the last visit. This questionnaire provided a subjective assessment of the subject’s sleep over a predefined time period. TST was assessed based on the responses to the sleep questionnaire.|Baseline and 12 Months (from the 1st dose to the end of study)|Intent to treat population||Minutes||Standard Deviation|Mean
858571|NCT00857220|Secondary|Change From Baseline at Month 12 in Subjective Number of Awakening After Sleep Onset (NAASO)|The sleep questionnaire, a Sponsor produced questionnaire used in previous eszopiclone studies, asked the subject or parent/guardian to report information about the subject’s sleep and daytime functioning since the last visit. This questionnaire provided a subjective assessment of the subject’s sleep over a predefined time period. NAASO was assessed based on the responses to the sleep questionnaire.|Baseline and 12 Months (from the 1st dose to the end of study)|Intent to treat population||Number of Awakenings||Standard Deviation|Mean
858572|NCT00857220|Secondary|Change From Baseline at Month 12 in Subjective Wake Time After Sleep Onset (WASO)|The sleep questionnaire, a Sponsor produced questionnaire used in previous eszopiclone studies, asked the subject or parent/guardian to report information about the subject’s sleep and daytime functioning since the last visit. This questionnaire provided a subjective assessment of the subject’s sleep over a predefined time period. WASO was assessed based on the responses to the sleep questionnaire.|Baseline and 12 Months (from the 1st dose to the end of study)|Intent to treat population||Minutes||Standard Deviation|Mean
858573|NCT00857220|Secondary|Change From Baseline in Conners’ Continuous Performance Test II (CCPT II)|The CCPT-II is a computer-based 14-minute, visual-performance task. During an administration, respondents were required to press the space bar or click the mouse whenever any letter except the target letter appears on the screen. The speed at which the letters were presented varied during the administration. There were 6 blocks, with 3 sub-blocks, each containing 20 trials (letter presentations). The interstimulus intervals (ISIs) were 1, 2, and 4 seconds with a display time of 250 milliseconds. The order in which the different ISIs were presented varied between blocks. Conners’ CCPT-II provides the following measures:% Omissions,% Commissions, Hit Reaction Time, Hit Reaction Time Standard Error,Variability of Standard Error, Detectability (d’), Response Style (beta), Perseverations, Hit Reaction Time Block Change (Vigilance Measure), Hit Standard Error Block Change (Vigilance Measure), Hit Reaction Time ISI change, and Hit Standard Error ISI Change, Confidence Index.|Baseline and 12 Months (from the 1st dose to the end of study)|Intent to treat population||percentage of score||Standard Deviation|Mean
858574|NCT00857220|Secondary|Change From Baseline in Pediatric Daytime Sleepiness Scale (PDSS)at Month 12|The PDSS total score ranges from a low of 0 where the individual is endorsing each item at the lowest level of daytime sleepiness to a high of 32 where the individual is endorsing each item at the highest level of daytime sleepiness.|Baseline and 12 Months (from the 1st dose to the end of study)|Intent to Treat Population||units on a scale||Standard Deviation|Mean
858575|NCT00857220|Secondary|Change From Baseline in Child Behavior Checklist (CBCL)|CBCL was completed by parents or guardians who saw the child in home-like settings. It includes several competence items, open-ended items for describing the child's illnesses, disabilities, concerns about the child, best things about the child, and several items to rate behavioral, emotional, and social problems. Responses are recorded on a Likert scale: 0 = Not True, 1 = Somewhat or Sometimes True, 2 = Very True or Often True. The checklist contains 120 questions. The standardized score is computed by determining the z-score by subtracting the mean for the subject’s age group and gender from the raw score and then dividing this by the standard deviation for the subject’s age group and gender. Next, multiply the zscore by 15 and then add 100. For activities scale, social scale, school scale, and total competence scale, higher values indicate higher competencies. For Internalizing problems, externalizing problems, and total problems, higher values indicate more problems.|Baseline and 12 Months (from the 1st dose to the end of study)|Intent to treat population||units on a scale||Standard Deviation|Mean
858576|NCT00857220|Secondary|Change From Baseline at Month 12 in Subjective Sleep Latency (SL)|Sleep latency is the amount of time it takes to fall asleep after the lights have been turned off.|Baseline and 12 Months (from the 1st dose to the end of study)|Intent to treat population||Minutes||Standard Deviation|Mean
858577|NCT00857220|Secondary|Clinical Global Impression (CGI) Improvement Score as Assessed by Parent/Caregiver or Child at Month 12|A 7-point scale was used for improvement with numeric values assigned to each of the responses: very much improved (1), much improved (2), minimally improved (3), no change (4), minimally worse (5), much worse (6), and very much worse (7).|Baseline and 12 Months (from the 1st dose to the end of study)|Intent to treat population||units on a scale||Standard Deviation|Mean
858606|NCT00780715|Primary|HbA1c Change|Units are absolute difference in %HbA1c (HbA1c being the percentage of glycated Haemoglobin, reflecting glucose exposure over the last 3 months)|6 months|Modified Intention to treat||absolute change in %HbA1c||Standard Deviation|Mean
858669|NCT00658814|Primary|30-Day Survival|Patients surviving more than 30 days after study registration|30 days|||percentage of participants||95% Confidence Interval|Number
858578|NCT00857220|Secondary|Change From Baseline in Coding Copy Subtest A or B, or Digit Symbol Substitution Test (DSST)at Month 12|These tests are standardized information processing tasks to assess recognition and recoding of sensory information. The subject was given 90 seconds to complete as many substitutions of symbols as possible according to a code provided on top of the sheet. The Coding Copy Subtest A was used for subjects 6 to 7 years of age, the Coding Copy Subtest B was used for subjects 8 to 16 years of age, and the DSST was used for subjects 17 years of age. The DSST consists of rows containing small blank squares, each paired with a randomly assigned numbers 1-9. Above the rows is a key that pairs each number with a symbol. The subject must fill in the blank spaces with the matching symbol that is in the key. For the Subcopy tests the subject simply copies the symbol above each empty square. Scaled scores are used to account for age differences among test takers. Scaled scores range from 1 to 19, and higher scores indicate higher cognitive function.|Baseline and 12 Months (from the 1st dose to the end of study)|Intent to Treat Population||score||Standard Deviation|Mean
858579|NCT00857220|Secondary|Columbia-Suicide Severity Rating Scale (C-SSRS) Item Responses|The C-SSRS is a physician-completed scale to assess any suicidal ideation and suicidal behavior. The C-SSRS contained questions about suicidal behavior and suicidal ideation. Subjects were placed into categories for suicidal behavior and for suicidal ideation based on their responses to various questions. Any suicidality was defined as suicidal behavior or suicidal ideation. The suicidal behavior categories were determined based on the response to the questions under suicidal behavior (Completed Suicide, Actual Attempt, Interrupted Attempt, Aborted Attempt, Preparatory Acts or Behavior).The suicidal ideation categories were determined by examining the response to 5 questions under suicidal ideation (Wish to be Dead, Nonspecific Active Suicidal Thoughts, Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act, Active Suicidal Ideation with Some Intent to Act, without Specific Plan, Active Suicidal Ideation with Specific Plan and Intent).|12 Months|Intent to treat population||Subjects|||Number
858580|NCT00857220|Secondary|Overall Incidence of Skin Reactions: Number of Participant Affected||12 Months (from the 1st dose to the end of study)|Intent to treat population||participants|||Number
858581|NCT00857220|Secondary|Overall Incidence of Skin Reactions: Number of Events||12 Months (from the 1st dose to the end of study)|Intent to treat population||Events|||Number
858582|NCT00857220|Primary|Overall Incidence of Adverse Events||12 Months (from the 1st dose to the end of study)|The intent-to-treat (ITT) population consisted of all enrolled subjects who had taken any study medication. One subject did not receive study medication||participants|||Number
858583|NCT00811317|Secondary|Insulin and Glucagon Levels During Closed Loop and Open Loop Admissions of Diabetic Subjects Compared to the Comparable 24 Hour Period During the Admission of Non-diabetic Subject||24 hours|This outcome was not analyzed. There were no experiments in non-diabetic subjects that we were able to make a comparison with|||||
858584|NCT00811317|Secondary|Set Point Using CGM Data as the Input to the Controller for Future Studies|The algorithm in the Bionic Pancreas must have a pre-specified target glucose it is trying to achieve in order to make dosing decisions. Using data from this study, investigators planned to determine what an appropriate glucose target should be for future studies.|24 hours|||mg/dl|||Number
858585|NCT00811317|Secondary|Sensitivity for Hypo- and Hyperglycemia of the CGM Devices Using the BG Measurement as the Standard|Mean absolute relative difference (MARD) of CGM and BG glucose readings in hypoglycemia (< 70 mg/dl) and hyperglycemia (>180 mg/dl) in three different CGM devices: Dexcom, Navigator and Guardian|24 hours|||percent absolute difference||Standard Deviation|Mean
858586|NCT00811317|Secondary|Insulin and Glucagon Levels During the Closed-loop Admission as Compared to the Comparable 24 Hour Period During the Open Loop Admission of Diabetic Subjects||24 hours|This outcome was not analyzed. There were no open loop experiments in diabetic subjects that we were able to make a comparison with|||||
858587|NCT00811317|Secondary|Average Glucose and Glycemic Variability During Closed Loop Control in Diabetic Subjects Compared to the Comparable 24 Hour Period in Non-diabetic Subjects||24 hours|This outcome was not analyzed. There were no experiments in non-diabetic subjects that we were able to make a comparison with|||||
858588|NCT00811317|Secondary|Accuracy of the Continuous Glucose Monitor (CGM) Using Blood Glucose Measurement as the Standard|Measuring the mean absolute relative difference (MARD) between the blood glucose measurement and CGM glucose readings, on three different CGM devices: Dexcom, Guardian and Navigator|24 hours|||percent absolute difference||Standard Deviation|Mean
858589|NCT00811317|Secondary|Number of Participants Achieving a Stable Glucose Response to Insulin Dosing Around Idle Times Prior to Meals||24 hours|||participants|||Number
858590|NCT00811317|Secondary|Number of Participants Achieving a Stable Glucose Response to Insulin Dosing||24 hours|||participants|||Number
858591|NCT00811317|Secondary|Number of Carbohydrate Interventions||24 hours|||number of interventions|||Number
858592|NCT00811317|Secondary|Average Glucose and Glycemic Variability (MAGE) During Closed Loop Control in Diabetic Subjects Compared to the Comparable 24-hour Period the Day Prior to Admission as Measured by Navigator CGM Data||24 hours|Navigator CGM data from the day prior to admission was not obtained|||||
858593|NCT00811317|Secondary|Blood Glucagon Levels||24 hours|||microgram/kg||Standard Deviation|Mean
858594|NCT00811317|Secondary|Total Glucagon Dose||24 hours|||mcg/kg||Standard Deviation|Mean
858595|NCT00811317|Secondary|Glucagon T-max|Time to maximum peak glucagon concentration|24 hours|||minutes||Standard Deviation|Mean
858596|NCT00811317|Secondary|Total Insulin Dose||24 hours|||u/kg||Standard Deviation|Mean
858597|NCT00811317|Secondary|Percentage of Time Spent With BG > 180 mg/dl||24 hours|||percentage of time||Standard Deviation|Mean
858598|NCT00811317|Secondary|Nadir Blood Glucose Level for Each Hypoglycemic Event||24 hours|||mg/dl|||Number
858599|NCT00811317|Secondary|Number of Hypoglycemic Events|This outcome captures the number of hypoglycemic events that occurred throughout the entire study|24 hours|||Number of events|||Number
858600|NCT00811317|Secondary|Percentage of Time Spent With BG < 70 mg/dl||24 hours|||percentage of time||Standard Deviation|Mean
858601|NCT00811317|Secondary|Percentage of Peak Post-prandial Hyperglycemias < 180 mg/dl (ADA Target)||24 hours|||percentage of blood glucose measurements|||Number
858602|NCT00811317|Secondary|Percentage of Time Spent in Hyperglycemia (BG> 180 mg/dl) After Meals||After each of 3 meals|||percentage of time||Standard Deviation|Mean
858603|NCT00811317|Secondary|Peak Hyperglycemia Following Each Meal||After each of 3 meals|||mg/dl||Standard Deviation|Mean
858622|NCT00731731|Primary|Overall Survival at 15 Months (Phase II)|The primary endpoint will be survival status at 15 months (OS15). In addition, survival will be estimated using a Kaplan-Meier curve. For this analysis, patients who are still alive at the time of analysis have survival time censored at the last contact date.|Time from study registration to the date of death from any cause, assessed up to 5 years|||percentage of phase II patients||95% Confidence Interval|Number
858623|NCT00731731|Primary|Maximum Tolerated Dose of Vorinostat, Defined as the Dose at Which Fewer Than One-third of Patients Experience DLTs, Graded According to NCI CTCAE (Common Toxicity Criteria for Adverse Effects) Version 3.0 (Phase I)|"The Maximum Tolerated Dose (MTD) will be based on the assessment of Dose Limiting Toxicity (DLT) during the first 10 weeks of treatment only, and will be defined as the dose at which fewer than one-third of patients experience a DLT to vorinostat. The MTD is the dose level at which 0/3 or 1/6 patients experience DLT with the next higher dose having at least 2/3 or 2/6 patients encountering DLT.
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DLT will be defined as any of the following events occurring during treatment with vorinostat and temozolomide and attributable to one or both study drugs:
Grade 3 or 4 thrombocytopenia, grade 4 anemia or grade 4 neutropenia lasting > 7 days
Any non-hematologic grade 3 or greater adverse event, excluding alopecia and venous thromboembolism
Grade 4 radiation-induced skin changes
Failure to recover from toxicities to be eligible for re-treatment with vorinostat and temozolomide ≤ 14 days of the last dose of the two drugs"|10 weeks|||number of patients with DLT|||Number
858624|NCT00725322|Secondary|NRS Score Three Weeks After Injection|The NRS scores range from 0-100, where 0 indicated no pain and 100 indicated the worst pain.|Three weeks after injection|Although 27 participants completed the study, 3 participants were excluded from analysis of the NRS score because they had missing data.||Units on a scale||Standard Deviation|Mean
858625|NCT00725322|Primary|Time Until Analgesic Failure|Participants made daily NRS reports via Palm Pilot, and “failure” was defined as (Pre-injection baseline NRS) – (Mean NRS for any 3 preceding days) ≤ 0; or 9 months|Each participant was assessed for up to 224 days per intervention (injection) or until they returned to NRS baseline|||Days||Standard Deviation|Mean
858626|NCT00699816|Secondary|Cancer-specific Survival Rate|Cancer-specific survival rate was measured from the date of randomization until death resulting from HCC.|Every 3 months from baseline for 24 months, and then every 3-6 months until the data cut-off date, up to LSLV(Last Subject Last Visit)|||percentage of participants|||Number
858627|NCT00699816|Secondary|Overall Survival(OS) Rate|Overall survival rate was measured from the date of randomization until death from any cause.|Every 3months from the baseline for 24 months, and then every 3-6 months until the data cut-off date, up to LSLV(Last Subject Last Visit)|||percentage of participants|||Number
858628|NCT00699816|Primary|Recurrence Free Survival(RFS) Rate|RFS rate was measured from the date of randomization to the first recurrence or to death from any cause.|Every 3months from the baseline for 24 months, and then every 3-6 months until the data cut-off date, up to LSLV(Last Subject Last Visit)|||percentage of participants|||Number
858629|NCT00699816|Secondary|Cancer-specific Survivals|Cancer-specific survival was measured from the date of randomization until death resulting from HCC.|Every 3 months from baseline for 24 months, and then every 3-6 months until the data cut-off date, up to LSLV(Last Subject Last Visit)|||months||95% Confidence Interval|Median
858630|NCT00699816|Secondary|Overall Survival(OS)|Overall survival was measured from the date of randomization until death from any cause.|Every 3months from the baseline for 24 months, and then every 3-6 months until the data cut-off date, up to LSLV(Last Subject Last Visit)|||months||95% Confidence Interval|Median
858631|NCT00699816|Primary|Recurrence Free Survival(RFS)|RFS was measured from the date of randomization to the first recurrence or to death from any cause.|Every 3months from the baseline for 24 months and then every 3-6 months until the data cut-off date, up to LSLV(Last Subject Last Visit)|||months||95% Confidence Interval|Median
858670|NCT00658814|Primary|Complete Response|Morphologic complete remission (CR): ANC >=1,000/mcL, platelet count >=100,000/mcL, <5% bone marrow blasts, no Auer rods, no evidence of extramedullary disease. Morphologic complete remission with incomplete blood count recovery (CRi): Same as CR but ANC may be <1,000/mcL and/or platelet count <100,000/mcL.|Up to 60 days|||percentage of participants||95% Confidence Interval|Number
858793|NCT00126581|Other Pre-specified|Overall Response Rate by EGFR Mutation Status|Response and EGFR mutation status are defined in previous outcome measures.|Duration of study (up to 3 years)|EGFR mutation analysis was successfully performed in 164 participants; 17 participants had insufficient material or DNA for analysis.||percentage of participants|||Number
858671|NCT00658814|Secondary|Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Up to 5 years|Eligible patients who received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.||Participants|||Number
858661|NCT00676715|Secondary|Total Number of Gadolinium-Enhancing T1 Lesions at Weeks|Total number of gadolinium-enhancing T1 lesions at weeks were reported.|Weeks 4 to Week 24|The intent-to-treat population includes all randomized participants who had received any study drug. Here, number of participants analysed signifies the participants who were evaluable for the outcome.||Lesions||Standard Deviation|Mean
858662|NCT00676715|Secondary|Total Number of New Gadolinium-Enhancing T1 Lesions Observed by MRI Scans of the Brain|Total number of new gadolinium-enhancing T1 lesions observed by MRI scans of the brain were reported.|Weeks 4 to Week 24|The intent-to-treat population includes all randomized participants who had received any study drug. Here, number of participants analysed signifies the participants who were evaluable for the outcome.||Lesions||Standard Deviation|Mean
858663|NCT00676715|Secondary|Change From Baseline in Total Volume of T2 Lesions on MRI Scans of the Brain at Week 24|Change from baseline in total volume of T2 lesions on MRI scans of the Brain at week 24 was reported.|Baseline, Week 24|The intent-to-treat population includes all randomized participants who had received any study drug. Here, n signifies the number of participants evaluated at specified time points.||Cubic Millimeter (mm^3)||Standard Deviation|Mean
858664|NCT00676715|Secondary|Percentage of Participants Who Remained Relapse Free at Week 24|Percentage of participants who remained relapse free at week 24 were reported.|Week 24|The intent-to-treat population includes all randomized participants who had received any study drug.||percentage of participants||95% Confidence Interval|Number
858665|NCT00676715|Secondary|Annualized Protocol Defined Relapse Rate at Week 24|Adjusted annualized relapse rate for geographical region.|Week 24|The intent-to-treat population includes all randomized participants who had received any study drug.||Number of relapses||95% Confidence Interval|Number
858666|NCT00676715|Primary|Total Number of Gadolinium-Enhancing T1 Lesions Observed on MRI Scans of the Brain|Mean of total number of gadolinium-enhancing T1 lesions observed on MRI scans of the brain at Weeks 12, 16, 20, 24 was determined using average imputation method.|Week 12 to Week 24|The intent-to-treat population includes all randomized participants who had received any study drug. Here, number of participants analysed signifies the participants who were evaluable for the outcome.||Lesion||Standard Deviation|Mean
858667|NCT00672204|Primary|The Proportion of Insulin-independent Subjects With Full Islet Graft Function|"Islet transplant recipients will be considered insulin-independent with full islet graft function if they are able to titrate off insulin therapy for at least 1 week and all of the following criteria are met:
HbA1c < 7.0% or a ≥2.5% decrease from baseline;
fasting capillary glucose level should not exceed 140 mg/dL (7.8 mmol/L) more than three times in the past week (based on measuring capillary glucose levels a minimum of 7 times in a seven day period);
2-hour post-prandial capillary glucose should not exceed 180 mg/dl (10.0 mmol/L) more than three times in the past week (based on measuring capillary glucose levels a minimum of 21 times in a seven day period);
fasting serum glucose level ≤126 mg/dL (7.0 mmol/L); if the fasting serum glucose level is >126 mg/dL (7.0 mmol/L), it must be confirmed in an additional one out of two measurements;
evidence of endogenous insulin production defined as fasting or stimulated C-peptide levels ≥0.5 ng/mL (0.16 nmol/L)."|1 year following the first islet transplant|Raptiva was removed from market after 3 subjects were transplanted||participants|||Number
858668|NCT00658814|Secondary|Relapse-free Survival|Relapse-free survival (RFS) is defined for all patients who achieve CR or CRi. RFS is measured from the date CR or CRi is first achieved until relapse or death form any cause, with observation censored on the date of last contact for patients last known to be alive without report of relapse. Relapse from CR/CRi is defined as reappearance of leukemic blasts in the peripheral blood; or > 5% blasts in the bone marrow not attributable to another cause; or appearance or reappearance of extramedullary disease.|Up to 5 years|||months||95% Confidence Interval|Median
858672|NCT00616759|Primary|Wechsler Memory Scale-III (WMS-III) Auditory Delayed Index|WMS-III Auditory Delayed Index is a measure of memory functioning. The results given are the post-ECT testing results. A smaller number indicates less memory disturbance on this scale. The range of scores is between 0-140 with higher scores indicating better memory function.|Pre-tesing within 36 hours before first ECT; Post-testing within 36 hours of 6th ECT.|The measurements listed are post-ECT testing for both groups||units on a scale||Standard Deviation|Mean
858673|NCT00616759|Secondary|California Verbal Learning Test (CVLT)|CVLT consists of a number of individual subtests of various aspects of memory. Higher scores indicate better memory function.|Within one week pre-ECT and within 48 hours after the 6th ECT||||||
858674|NCT00586339|Primary|CMI (B-cell Responses) Related to HPV 16/18 Virus-like Particles (VLPs) Measured by Flow Cytometry|The CMI response is expressed by the number of subjects with B-cell response to VLP-16 and VLP-18 above (>) 0 as measured by Flow cytometry.|At Month 12|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available at the considered time points.||Participants|||Count of Participants
858675|NCT00586339|Primary|CMI (B-cell Responses) Related to HPV 16/18 Virus-like Particles (VLPs) Measured by Flow Cytometry|The CMI response is expressed by the number of subjects with B-cell response to VLP-16 and VLP-18 above (>) 0 as measured by Flow cytometry.|At Month 7|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available at the considered time points.||Participants|||Count of Participants
858676|NCT00586339|Primary|CMI B-cell Responses Related to HPV 16/18 Virus-like Particles (VLPs) Measured by Flow Cytometry|The CMI response is expressed by the number of subjects with B-cell response to VLP-16 and VLP-18 above (>) 0 as measured by Flow cytometry.|At Month 2|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available at the considered time points.||Participants|||Count of Participants
858677|NCT00586339|Primary|Cell Mediated Immune Response (CMI) (B-cell Responses) Related to HPV 16/18 Virus-like Particles (VLPs) Measured by Flow Cytometry|The CMI response is expressed by the number of subjects with B-cell response to VLP-16 and VLP-18 above (>) 0 as measured by Flow cytometry.|At Month 0|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available at the considered time points.||Participants|||Count of Participants
858678|NCT00586339|Primary|Cell Mediated Immune Response (CMI) (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellullar Cytokine Staining (ICS)|The CMI response is the measure of the cytokines production (i.e. Cluster of Differentiation 40 Ligand (CD40L), Interferon gamma (IFN-γ), interleukin-2 (IL-2) and tumor necrosis factor alpha (TNF-α) by HPV-antigen specific T lymphocytes and measured by intracellular cytokine staining assay. The results were expressed as a frequency of positive CD4 or CD8 T cell producing at least 1 cytokine within the CD4 or CD8 T cell sub-population. All doubles= T cell expressing at least 2 cytokines.|At Months 0, 2, 7 and 12|The According-To-Protocol cohort for immunogenicity included evaluable subjects (i.e. those HPV DNA- subjects during the vaccination phase) for whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post-vaccination.||Cells||Inter-Quartile Range|Geometric Mean
858679|NCT00586339|Primary|Concentrations for HPV-16 and HPV-18 Antibodies|"Concentrations were expressed as geometric mean antibody concentrations (GMCs) and were given in EL.U/mL.
The antibody concentrations against HPV-16 and HPV-18 were determined by Enzyme-linked immunosorbent assay (ELISA). The cut-off values of the assay were 8 EL.U/mL for anti-HPV-16 and 7 EL.U/mL for anti-HPV-18."|At Month 12|The According-To-Protocol cohort for immunogenicity included evaluable subjects (i.e. those HPV DNA- subjects during the vaccination phase) for whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post-vaccination.||EL.U/mL||95% Confidence Interval|Geometric Mean
858680|NCT00586339|Primary|Concentrations for HPV-16 and HPV-18 Antibodies|"Concentrations were expressed as geometric mean antibody concentrations (GMCs) and were given in EL.U/mL.
The antibody concentrations against HPV-16 and HPV-18 were determined by Enzyme-linked immunosorbent assay (ELISA). The cut-off values of the assay were 8 EL.U/mL for anti-HPV-16 and 7 EL.U/mL for anti-HPV-18."|At Months 0, 2 and 7|The According-To-Protocol cohort for immunogenicity included evaluable subjects (i.e. those HPV DNA- subjects during the vaccination phase) for whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post-vaccination.||EL.U/mL||95% Confidence Interval|Geometric Mean
858681|NCT00586339|Primary|Number of Seroconverted Subjects for HPV-16 and HPV-18 Antibodies|"Seroconversion was defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (anti-HPV-16 titers ≥ 8 ELISA units per milliliter (EL.U/mL) and anti-HPV-18 titers ≥ 7 EL.U/mL) in the serum of subjects seronegative before vaccination.
A seronegative subject was a subject whose antibody titres are below the cut-off value.
Due to the high proportion of initially seropositive subjects in the study population, seroconversion rates were considered for all subjects in the ATP cohort for immunogenicity regardless of baseline serostatus."|At Month 12|The According-To-Protocol cohort for immunogenicity included evaluable subjects (i.e. those HPV DNA- subjects during the vaccination phase) for whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post-vaccination.||Participants|||Count of Participants
858682|NCT00586339|Primary|Number of Seroconverted Subjects for HPV-16 and HPV-18 Antibodies.|"Seroconversion was defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (anti-HPV-16 titers ≥ 8 ELISA units per millilitre (EL.U/mL) and anti-HPV-18 titers ≥ 7 EL.U/mL) in the serum of subjects seronegative before vaccination.
A seronegative subject was a subject whose antibody titres are below the cut-off value.
Due to the high proportion of initially seropositive subjects in the study population, seroconversion rates were considered for all subjects in the ATP cohort for immunogenicity regardless of baseline serostatus."|At Months 2 and 7|The According-To-Protocol cohort for immunogenicity included evaluable subjects (i.e. those HPV DNA- subjects during the vaccination phase) for whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post-vaccination.||Participants|||Count of Participants
858683|NCT00586339|Primary|HIV Viral Load at Each Time Point in All HIV+ Subjects|The viral load was calculated by estimating the amount of virus in blood samples and was given in number of Ribonucleic acid (RNA) copies per milliliter.|At Month 10 and Month 12|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||RNA copies/mL (in log10)||Inter-Quartile Range|Median
858684|NCT00586339|Primary|HIV Viral Load at Each Time Point in All HIV+ Subjects|The viral load was calculated by estimating the amount of virus in blood samples and was given in number of Ribonucleic acid (RNA) copies per milliliter.|At pre-vaccination and at Months 1, 2, 4, 6 and 7|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||RNA copies/mL (in log10)||Inter-Quartile Range|Median
858685|NCT00586339|Primary|Number of CD4+ Cells Per Cubic Millimeter at Each Time Point in All HIV+ Subjects|The number of CD4+ cells per cubic millimeter at each time point in all HIV+ subjects is reported.|At Month 10 and Month 12|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||cells/mm^3||Inter-Quartile Range|Median
858686|NCT00586339|Primary|Number of CD4+ Cells Per Cubic Millimeter at Each Time Point in All HIV+ Subjects|The number of CD4+ cells per cubic millimeter at each time point in all HIV+ subjects is reported.|At pre-vaccination and at Months 1, 2, 4, 6 and 7|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||cells/mm^3||Inter-Quartile Range|Median
858687|NCT00586339|Primary|Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage at Each Time Point by Cluster of Differentiation 4 (CD4+) Cell Count Category at Baseline in All HIV+ Subjects.|CD4+ cell count categories, at baseline, assessed were (i) below 200 CD4+ cells per cubic millimetre (mm^3), (ii) between 200 and 500 CD4+ cells/mm^3 and (iii) above 500 CD4+ cells/mm^3. WHO classification of HIV-associated clinical disease: 1 = Asymptomatic HIV-associated symptoms = WHO clinical stage 1 2 = Mild HIV-associated symptoms = WHO clinical stage 2 3 = Advanced HIV-associated symptoms = WHO clinical stage 3 4 = Severe HIV-associated symptoms = WHO clinical stage 4|At Month 10 and Month 12|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Participants|||Count of Participants
858688|NCT00586339|Primary|Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage at Each Time Point by Cluster of Differentiation 4 (CD4+) Cell Count Category at Baseline in All HIV+ Subjects.|"CD4+ cell count categories, at baseline, assessed were (i) below 200 CD4+ cells per cubic millimetre (mm^3), (ii) between 200 and 500 CD4+ cells/mm^3 and (iii) above 500 CD4+ cells/mm^3.
WHO classification of HIV-associated clinical disease:
= Asymptomatic HIV-associated symptoms = WHO clinical stage 1
= Mild HIV-associated symptoms = WHO clinical stage 2
= Advanced HIV-associated symptoms = WHO clinical stage 3
= Severe HIV-associated symptoms = WHO clinical stage 4"|At Months 1, 2, 4, 6 and 7|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Participants|||Count of Participants
858689|NCT00586339|Primary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.|Laboratory parameters assessed were alanine aminotransferase (ALAT), creatinine (CREA), white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), red blood cells (RBC), haemoglobin (Hgb), haematocrit (Hct) and platelets (PLA). For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated). Parameters presented in this table are NEU, PLA, RBC and WBC.|At Month 10 and Month 12|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Participants|||Count of Participants
858690|NCT00586339|Primary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.|Laboratory parameters assessed were alanine aminotransferase (ALAT), creatinine (CREA), white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), red blood cells (RBC), haemoglobin (Hgb), haematocrit (Hct) and platelets (PLA). For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated). Parameters presented in this table are ALAT, BAS, CREA, EOS, Hct, Hgb, LYM and MON.|At Month 10 and Month 12|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Participants|||Count of Participants
858691|NCT00586339|Primary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.|"Laboratory parameters assessed were alanine aminotransferase (ALAT), creatinine (CREA), white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), red blood cells (RBC), haemoglobin (Hgb), haematocrit (Hct) and platelets (PLA).
For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated).
The parameter presented in this table is alanine aminotransferase (ALAT)."|At Day 7 and at Months 1, 2, 4, 6 and 7|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Participants|||Count of Participants
858692|NCT00586339|Primary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.|"Laboratory parameters assessed were alanine aminotransferase (ALAT), creatinine (CREA), white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), red blood cells (RBC), haemoglobin (Hgb), haematocrit (Hct) and platelets (PLA).
For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated).
Parameters presented in this table are eosinophils (EOS), basophils (BAS) and creatinine (CREA)."|At Day 7 and at Months 1, 2, 4, 6 and 7|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Participants|||Count of Participants
858731|NCT00392236|Primary|Percent of Prescribed Medication Taken as Assessed by the Medication Event Monitoring System (MEMS)|Estimated percent of prescribed medication taken during month 6 of the study was calculated using all available data sources (MEMS supplemented by subject interview and pill counts).|Measured at Month 6|||percentage of prescribed medication take||Standard Deviation|Mean
858732|NCT00390429|Secondary|Correlation of EGFR Polymorphisms With Treatment Response and Clinical Outcome||Completion of study||||||
858693|NCT00586339|Primary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.|"Laboratory parameters assessed were alanine aminotransferase (ALAT), creatinine (CREA), white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), red blood cells (RBC), haemoglobin (Hgb), haematocrit (Hct) and platelets (PLA).
For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated).
Parameters presented in this table are lymphocytes (LYM) and monocytes (MON)."|At Day 7 and at Months 1, 2, 4, 6 and 7|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Participants|||Count of Participants
858694|NCT00586339|Primary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.|"Laboratory parameters assessed were alanine aminotransferase (ALAT), creatinine (CREA), white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), red blood cells (RBC), haemoglobin (Hgb), haematocrit (Hct) and platelets (PLA).
For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated).
Parameters presented in this table are white blood cells (WBC) and neutrophils (NEU)."|At Day 7 and at Months 1, 2, 4, 6 and 7|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Participants|||Count of Participants
858695|NCT00586339|Primary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed|"Laboratory parameters assessed were alanine aminotransferase (ALAT), creatinine (CREA), white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), red blood cells (RBC), haemoglobin (Hgb), haematocrit (Hct) and platelets (PLA).
For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated).
Parameters presented in this table are red blood cells (RBC) and platelets (PLA)."|At Day 7 and at Months 1, 2, 4, 6 and 7|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Participants|||Count of Participants
858696|NCT00586339|Primary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed|Laboratory parameters assessed were alanine aminotransferase (ALAT), creatinine (CREA), white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), red blood cells (RBC), haemoglobin (Hgb), haematocrit (Hct) and platelets (PLA). For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated). Parameters presented in this table are haemoglobin (Hgb) and haematocrit (Hct).|At Day 7 and at Months 1, 2, 4, 6 and 7|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Participants|||Count of Participants
858697|NCT00586339|Primary|Number of Subjects With Pregnancies and Their Outcome|Pregnancy outcome with live infant having no apparent congenital anomaly.|From Day 0 up to Month 12|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Participants|||Count of Participants
858698|NCT00586339|Primary|Number of Subjects Reporting Serious Adverse Events|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or a congenital anomaly/birth defect in the offspring of a study subject.|From Day 0 up to Month 12|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Participants|||Count of Participants
858699|NCT00586339|Primary|Number of Subjects With Medically Significant Conditions|"MSCs were collected regardless of causal relationship to vaccination and intensity.
Medically significant conditions were defined as adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or serious adverse events (SAEs) that were not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury."|From Day 0 up to Month 12|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Participants|||Count of Participants
858700|NCT00586339|Primary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or a congenital anomaly/birth defect in the offspring of a study subject.|From Day 0 up to Month 7|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Participants|||Count of Participants
858701|NCT00586339|Primary|Number of Subjects With Medically Significant Conditions (MSCs)|"Medically significant conditions (MSCs) were collected regardless of causal relationship to vaccination and intensity.
Medically significant conditions were defined as adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or serious adverse events (SAEs) that were not related to common diseases.
Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury."|From Day 0 up to Month 7|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Participants|||Count of Participants
858733|NCT00390429|Secondary|Correlation of Phospho-EGFR With Increased p27 and Clinical Outcome||Completion of study||||||
858734|NCT00390429|Secondary|Correlation of Basal Levels of p27 With Response Rate and Overall Survival||Completion of study (up to 36 months)||||||
858735|NCT00390429|Secondary|Correlation of Baseline EGFR Levels With Clinical Outcome||Completion of study (up to 36 months)||||||
858736|NCT00390429|Secondary|Prognostic Significance of Epithelial Growth Factor Receptor (EGFR) Expression||Completion of study (up to 36 months)||||||
858737|NCT00390429|Secondary|Frequency and Severity of Toxicities (Phase II)|Treatment-related adverse events Grade ≥3 by NCI CTCAE 2.0.|Completion of study (up to 36 months)|||participants|||Number
858702|NCT00586339|Primary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Symptoms|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|Within 30 days (Days 0-29) after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Participants|||Count of Participants
858703|NCT00586339|Primary|Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms|"Solicited general symptoms assessed were arthralgia, fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], gastrointestinal, headache, myalgia, rash and urticaria.
Any = occurrence of any solicited general symptom regardless of their intensity grade or relationship.
Grade 3 Symptom = symptom that prevented normal activity. Grade 3 Urticaria = Urticaria distributed on at least 4 body areas. Related = symptom assessed by the investigator as causally related to the vaccination."|Within 7 days (Days 0-6) after each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Participants|||Count of Participants
858704|NCT00586339|Primary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms|"Solicited local symptoms assessed were pain and swelling. Any = occurrence of any solicited local regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 swelling = swelling spreading beyond 50 millimeters (mm) of injection site.
Solicited local symptoms were assessed as related to the study vaccination."|Within 7 days (Days 0-6) after each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Participants|||Count of Participants
858738|NCT00390429|Secondary|Progression-free Survival (Phase II)||Completion of study (up to 65 months)|||months||Full Range|Median
858739|NCT00390429|Secondary|Overall Survival (Phase II)||Up to 65 months|||months||Full Range|Median
858740|NCT00390429|Secondary|Maximum Tolerated Dose of Two Different Schedules of Erlotinib Hydrochloride and Docetaxel (Phase I [Completed as of 12/01/2004])|Maximum tolerated dose (MTD) defined as the highest dose level at which no more than one patient experienced DLT when at least 6 patients were treated at that dose level and were assessable for toxicity, graded according to NCI CTCAE 2.0.|up to 36 months|"Phase I, arm A, MTD: erlotinib 600-1000 mg d 2, 9, and 16; and docetaxel 70 mg/m^2 d 1 on a 21-d cycle.
Phase I, arm B, MTD: erlotinib 150-300 mg d 2 and 16; and docetaxel 70 mg/m^2 d 1 on a 21-d cycle."||mg|||Number
858741|NCT00390429|Secondary|Comparison of Toxicity of Two Different Schedules of Erlotinib Hydrochloride and Docetaxel (Phase I [Completed as of 12/01/2004])||up to 36 months|||participants|||Number
858742|NCT00390429|Primary|Response Rate (Phase II)|Per Response Evaluation Criteria In Solid Tumors Criteria for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 36 months|All participants for whom response evaluation measurements were recorded at Baseline and after 2 cycles.||Participants|||Count of Participants
858743|NCT00390429|Primary|Safety and Toxicity of Erlotinib Hydrochloride and Docetaxel as Measured by NCI CTC v3.0 on Day 8 of Course 1 and on Day 1 of Every Subsequent Course (Phase I [Completed as of 12/01/2004])||Up to 36 months|||Participants|||Count of Participants
858744|NCT00331409|Secondary|Number of Participants With Adverse Events|"Toxicity assessments will be obtained as follows:
Cycle 1: Weeks 1,2,3 Cycle 2: Weeks 6,9 Cycle 3: Weeks 12, 15 Cycle 4: Weeks 18, 21 Cycle 5: Weeks 24, 27 Cycle 6+: Every visit during these cycles
Safety assessments will consist of evaluating adverse events and serious adverse events."|Duration of study, Up to 4 years|||participants|||Number
858745|NCT00331409|Secondary|Number of Subjects That Demonstrated a Reduction in Tumor Measurements.|Number of subjects that received at least one post-baseline scan that demonstrated a reduction in sum target lesions per Response Evaluation Criteria in Solid Tumors (RECIST) criteria.|Up to 4 years|2 subjects were not evaluable. Reduction in target lesion sum did not meet the criteria for Partial Response (PR) for any of the subjects. Partial Response, per RECIST, includes at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.||Participants|||Count of Participants
858746|NCT00331409|Secondary|Median Time to Progression||Time to progression|||months||95% Confidence Interval|Median
858747|NCT00331409|Primary|Overall Number of Participants Who Achieve a Response Rate (Complete Response, Partial Response, and Stable Disease) at 3 Months||Up to 4 years|||participants|||Number
858748|NCT00331409|Primary|Progression-free Survival at 3 Months||3 months post 1st dose|||months||95% Confidence Interval|Median
858754|NCT00321685|Secondary|5-year Recurrence-free Survival Rate|Recurrence free survival is defined as time from surgery to disease recurrence or death without recurrence (whichever occurred first) among resected patients. 5-year recurrence-free survival rate is estimated using Kaplan-Meier method, with 90% confidence interval calculated using Greenwood's formula.|recurrence follow-up began after post-operative chemotherapy, assessed every 3 months for patients 3-5 years from registration, every 6 months for patients 5-10 years from registration and every 12 months for patients 10 years from registration|Eligible and treated patients who underwent surgery after neoadjuvant therapy||percentage of participants||90% Confidence Interval|Number
858755|NCT00321685|Secondary|5-year Overall Survival Rate|Overall survival is defined as time from registration to death from any cause. 5-year overall survival rate is estimated using Kaplan-Meier method.|survival follow-up began after post-operative chemotherapy, assessed every 3 months for patients 3-5 years from registration, every 6 months for patients 5-10 years from registration and every 12 months for patients 10 years from registration|Eligible and treated patients||percentage of participants||90% Confidence Interval|Number
858756|NCT00321685|Secondary|Resection Rate for T4 Rectal Cancers|Resection rate is defined as number of patients with T4 rectal cancer who underwent curative surgical resection among all eligible and treated patients with T4 rectal cancers|Assessed at surgery time|eligible and treated patients with T4 rectal cancers||percentage of participants||90% Confidence Interval|Number
858757|NCT00321685|Secondary|Resection Rate for T3 Rectal Cancers|Resection rate is defined as number of patients with T3 rectal cancer who underwent curative surgical resection among all eligible and treated patients with T3 rectal cancers|Assessed at surgery time|eligible and treated patients with T3 rectal cancers||percentage of participants||90% Confidence Interval|Number
858758|NCT00321685|Primary|Pathologic Complete Response Rate|Pathologic complete response to preoperative therapy was determined at the time of surgical resection. Pathologic complete response (pCR) is defined as no evidence of invasive cells on pathologic examination of the primary rectal cancer (or tissue from the area where the tumor had been if there is a complete clinical response). Pathologic complete response rate is calculated as number of patients achieving pathologic complete response divided by all eligible and treated patients|Assessed at surgery time|Eligible and treated patients||percentage of participants||90% Confidence Interval|Number
858759|NCT00310401|Secondary|Chest X-ray Findings|Chest radiographs were scored using a radiographic score that scored each quadrant for extent of radiographic infiltrates on a scale of 0 to 4, then summed each quadrant for a total score from 0 (no infiltrates) to 16 (extensive infiltrates in all 4 radiographic quadrants).|change from enrollment to organ procurement (about ~40h after enrollment)|||units on a scale||Standard Deviation|Mean
858760|NCT00310401|Secondary|Pulmonary Vascular Resistance||72 hours|Insufficient data available to analyze this outcome|||||
858761|NCT00310401|Secondary|Lung Compliance||baseline and at organ procurement (about ~40h after enrollment)|||ml/cmH2O||Standard Deviation|Mean
858762|NCT00310401|Secondary|Donor Lung Utilization||72 hours|||Participants|||Count of Participants
858763|NCT00310401|Primary|Donor Oxygenation|The primary outcome was the change in oxygenation as measured by change in the PaO2/FiO2 ratio from study enrollment to organ procurement|Change from enrollment to organ procurement (about ~40h after enrollment)|||cmH2O||Inter-Quartile Range|Median
858769|NCT00249444|Primary|Depression Score on Hamilton - Depression 25 Item|Participants those who had a 50% decrease in HAM-D scores from baseline at end of study. The outcome measured is 50% drop in Hamilton score at week 8 or last week of study participation compared to baseline. We looked at the difference between baseline score and score at week 8 or last week of study participation.|End of 8 week study or last week of participation|||participants|||Number
858770|NCT00249444|Primary|Cocaine Abstinence During Last Three Weeks of Study|measured daily by self report and confimed by urine toxicology for 8 weeks of the trial or length of study participation|measured daily by self report and confimed by urine toxicology for 8 weeks of the trial or length of study participation|||participants|||Number
858771|NCT00233324|Secondary|Cerebral Palsy||18-22 months||||||
858772|NCT00233324|Secondary|Necrotizing Enterocolitis (NEC)||120 days||||||
858773|NCT00233324|Secondary|Received Postnatal Steroids||120 days||||||
858774|NCT00233324|Secondary|Blindness in at Least One Eye||18-22 months||||||
858775|NCT00233324|Secondary|Pulse Oximetry Values > 90%||120 days||||||
858776|NCT00233324|Secondary|Duration of Oxygen Supplementation||120 days||||||
858777|NCT00233324|Secondary|Endotracheal Intubation||Before 10 minutes of age||||||
858778|NCT00233324|Secondary|Threshold ROP Requiring Surgery||120 days||||||
858779|NCT00233324|Secondary|Periventricular Leukomalacia (PVL)||120 days||||||
858780|NCT00233324|Secondary|Severe Intraventricular Hemorrhage (IVH)||120 days||||||
858781|NCT00233324|Secondary|Death||18-22 months||||||
858782|NCT00233324|Secondary|Bronchopulmonary Disease (Using the Physiologic Definition of BPD)||36 weeks||||||
858783|NCT00233324|Secondary|Incidence of Air Leaks||120 days||||||
858784|NCT00233324|Secondary|Received Surfactant Treatment||120 days||||||
858785|NCT00233324|Secondary|Survival Without Ventilation||By day 7||||||
858786|NCT00233324|Secondary|Duration of Mechanical Ventilation||During entire NICU stay||||||
858787|NCT00233324|Secondary|Death or Neurodevelopmental Impairment||18-22 months|||participants|||Number
858788|NCT00233324|Other Pre-specified|Apgar Score||5 minutes||||||
858789|NCT00233324|Primary|Survival Without Severe Retinopathy of Prematurity (ROP) (Threshold Disease or the Need for Surgery)||55 weeks|49 infants in the lower oxygen saturation group and 46 infants in the higher oxygen saturation group that had unknown retinopathy of prematurity outcome||participants|||Number
858790|NCT00233324|Primary|Survival Without Bronchopulmonary Dysplasia (BPD)||36 weeks|||Participants|||Number
858791|NCT00126581|Other Pre-specified|Overall Response Rate With KRAS Mutational Status|Overall response is defined in previous outcome measures. GIven the small number of KRAS mutant participants in each treatment arm, the analysis combines data from both arms.|Duration of study (up to 3 years)|||percentage of participants||95% Confidence Interval|Number
858792|NCT00126581|Other Pre-specified|Progression Free Survival With KRAS Mutation Status|Progression free survival is defined in previous outcome measures. GIven the small number of KRAS mutant participants, the analysis combines data from both arms.|Duration of study (up to 3 years)|||months||95% Confidence Interval|Median
858794|NCT00126581|Other Pre-specified|Progression Free Survival (PFS) by Epidermal Growth Factor Receptor (EGFR) Mutation Status|"PFS was defined as the time from registration until disease progression or death, whichever occurs first. The median PFS with 95% CI was estimated using the Kaplan-Meier method. Progression is defined as in the primary outcome measure.
EGFR mutations were performed at the Dana-Farber Cancer Institute using a sensitive heteroduplex method coupled with enzymatic digestion as previously reported (Janne PA, et al: A rapid and sensitive enzymatic method for epidermal growth factor receptor mutation screening. Clin Cancer Res 12:751-758, 2006). All positive findings were independently verified and subjected to sequencing. The mutation analyses were blinded to the participants' clinical outcome."|Duration of treatment (up to 3 years)|EGFR mutation analysis was successfully performed in 164 participants; 17 participants had insufficient material or DNA for analysis.||months||95% Confidence Interval|Median
858795|NCT00126581|Other Pre-specified|Overall Survival|Overall survival (OS) is defined as the time from patient randomization (arm assignment) to death from any cause. The median OS with 95% CI was estimated using the Kaplan-Meier method.|Time from randomization to death (up to 3 years)|||months||95% Confidence Interval|Median
858796|NCT00126581|Secondary|Number of Participants With Grade 3, 4 or 5 Adverse Event at Least Possibly Related to Treatment.|"The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.
Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life Threatening; Grade 5: Death."|Duration of study (up to 3 years)|||participants|||Number
858797|NCT00126581|Secondary|Overall Response Rate|"The proportion of patients who respond (completely or partially) to each combination regimen will be estimated. An exact binomial confidence interval will be computed for these estimates.
Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria:
Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions"|Duration of Study (up to 3 years)|||percentage of participants||95% Confidence Interval|Number
858798|NCT00126581|Primary|18 Weeks Progression Free Survival (PFS) Rate|"The product limit estimator developed by Kaplan Meier will be used to graphically describe progression free survival for patients randomized to each study arm.
The 18 week progression-free survival rate was defined as the proportion of patients that were alive progression-free 18 weeks after registration into the study. Disease progression was assessed per modified RECIST criteria, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, in either primary or nodal lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of new lesions. Kaplan-Meier estimate of 18-week progression-free survival was calculated."|At 18 weeks|||percentage of participants||95% Confidence Interval|Number
858801|NCT00114101|Post-Hoc|Number of Participants With Progression, Death or Diagnosis of Second Primary Malignancy|Patients who develop progression (defined in primary outcome measure), died or develop a new primary malignancy (cancer) will summarized in this outcome.|Duration of study (up to 10 years)|||participants|||Number
858802|NCT00114101|Other Pre-specified|Overall Survival|Overall Survival was measured from the date of randomization to date of death due to any cause. OS was estimated using the Kaplan Meier method.|Duration of study (up to 10 years)|||months||95% Confidence Interval|Median
858803|NCT00114101|Secondary|Response to Autologous Hematopoietic Stem-cell Transplant (HSCT) at Day 100|"Response was defined according to International Myeloma Working Group criteria (2006)
Complete Response: Complete disappearance of M-protein from serum & urine on immunofixation, normalization of Free Light Chain (FLC) ratio & <5% plasma cells in bone marrow (BM)
Partial Response: >= 50% reduction in serum M-Component and/or Urine M-Component >= 90% reduction or <200 mg per 24 hours; or >= 50% decrease in difference between involved and uninvolved FLC levels
Marginal Response: 25-49% reduction in serum M-component & urine M-component by 50-89% which still exceeds 200mg/24hour
Progressive Disease: Defined in primary outcome measure
Stable Disease: Not meeting any of the criteria above"|Day 100|||participants|||Number
858804|NCT00114101|Primary|Time to Progression|"Time to progression (TTP) was defined as the date of transplant to date of progression or death due to any cause, whichever occurs first. TTP was estimated using the Kaplan Meier method.
Progression was defined per the International Myeloma Working Group definition as one more of the following:
25% increase in serum M-component (absolute increase >= 0.5g/dl)
25% increase in urine M-component (absolute increase >= 200mg/24hour
25% increase in the difference between involved and uninvolved Free Light Chain levels (absolute increase >= 10mg/dl)
25 % increase in bone marrow plasma cell percentage (absolute increase of >=10%)
Definite development of new bone lesion or soft tissue plasmacytomas
Development of hypercalcemia"|Duration of study (up to 10years)|||months||95% Confidence Interval|Median
858805|NCT00098475|Secondary|Proportion of Patients With Objective Response (First Phase, Step 2)|"Objective response is defined as either complete response (CR) or partial response (PR). Patients who have complete disappearance of an M-protein and no evidence of myeloma in the bone marrow are considered to have CR. PR requires all the following: (1) ≥50% reduction in the level of the serum monoclonal paraprotein. (2) Reduction in 24-hour urinary light chain excretion either by ≥90% or to <200 mg. (3)For patients with non-secretory (or oligosecretory) myeloma only, a ≥50% reduction in plasma cells in a bone marrow aspirate and on trephine biopsy must be documented. (4)50% reduction in size of soft tissue plasmacytoma (by radiography or clinical examination). (5) No increase in the number or size of lytic bone lesions (development of a compression fracture does not exclude response).
As the expansion phase was a substudy terminated early with only 7 patients enrolled, the clinical results presented are mainly for the first phase only."|Assessed every 4 weeks for 16 weeks during Step 2|Only eligible patients were included in this analysis.||Proportion of patients||95% Confidence Interval|Number
858806|NCT00098475|Primary|Proportion of Patients With Objective Response (First Phase, Step 1)|"Objective response is defined as either complete response (CR) or partial response (PR). Patients who have complete disappearance of an M-protein and no evidence of myeloma in the bone marrow are considered to have CR. PR requires all the following: (1) ≥50% reduction in the level of the serum monoclonal paraprotein. (2) Reduction in 24-hour urinary light chain excretion either by ≥90% or to <200 mg. (3)For patients with non-secretory (or oligosecretory) myeloma only, a ≥50% reduction in plasma cells in a bone marrow aspirate and on trephine biopsy must be documented. (4)50% reduction in size of soft tissue plasmacytoma (by radiography or clinical examination). (5) No increase in the number or size of lytic bone lesions (development of a compression fracture does not exclude response).
As the expansion phase was a substudy terminated early with only 7 patients enrolled, the clinical results presented are mainly for the first phase only."|Assessed every 4 weeks for 16 weeks during Step 1|Only eligible patients were included in this analysis.||Proportion of patients||95% Confidence Interval|Number
858807|NCT00095784|Secondary|Hemoglobin F|"Percentage of hemoglobin F as a proportion of total Hb (%HbF) measured by HPLC on peripheral blood samples.
Midpoint of 0.5% imputed for values reported as below limit of detection (1.0%). Hemoglobin F has been previously shown to be upregulated by decitabine in other hematologic disorders- sickle cell disease specifically. The rationale for exploring it in this study was to evaluate its potential utility as a biomarker of drug effect/PD marker."|Cycle 2, Day 12|Seven patients had missing data.||percentage of HbF||95% Confidence Interval|Mean
858808|NCT00095784|Secondary|Hemoglobin F|"Percentage of hemoglobin F as a proportion of total Hb (%HbF) measured by HPLC on peripheral blood samples.
Midpoint of 0.5% imputed for values reported as below limit of detection (1.0%). Hemoglobin F has been previously shown to be upregulated by decitabine in other hematologic disorders- sickle cell disease specifically. The rationale for exploring it in this study was to evaluate its potential utility as a biomarker of drug effect/PD marker."|Cycle 2, Day 5|Seven patients had missing data.||percentage of HbF||95% Confidence Interval|Mean
858809|NCT00095784|Secondary|Hemoglobin F|"Percentage of hemoglobin F as a proportion of total Hb (%HbF) measured by HPLC on peripheral blood samples.
Midpoint of 0.5% imputed for values reported as below limit of detection (1.0%). Hemoglobin F has been previously shown to be upregulated by decitabine in other hematologic disorders- sickle cell disease specifically. The rationale for exploring it in this study was to evaluate its potential utility as a biomarker of drug effect/PD marker."|Cycle 2, Day 1|Nine patients had missing data.||percentage of HbF||95% Confidence Interval|Mean
858810|NCT00095784|Secondary|Hemoglobin F|"Percentage of hemoglobin F as a proportion of total Hb (%HbF) measured by HPLC on peripheral blood samples.
Midpoint of 0.5% imputed for values reported as below limit of detection (1.0%). Hemoglobin F has been previously shown to be upregulated by decitabine in other hematologic disorders- sickle cell disease specifically. The rationale for exploring it in this study was to evaluate its potential utility as a biomarker of drug effect/PD marker."|Cycle 1, Day 12|Three patients had missing data.||percentage of HbF||95% Confidence Interval|Mean
858811|NCT00095784|Secondary|Hemoglobin F|"Percentage of hemoglobin F as a proportion of total Hb (%HbF) measured by HPLC on peripheral blood samples.
Midpoint of 0.5% imputed for values reported as below limit of detection (1.0%). Hemoglobin F has been previously shown to be upregulated by decitabine in other hematologic disorders- sickle cell disease specifically. The rationale for exploring it in this study was to evaluate its potential utility as a biomarker of drug effect/PD marker."|Cycle 1, Day 5|Three patients had missing data.||percentage of HbF||95% Confidence Interval|Mean
858812|NCT00095784|Secondary|Hemoglobin F|"Percentage of hemoglobin F as a proportion of total Hb (%HbF) measured by HPLC on peripheral blood samples.
Midpoint of 0.5% imputed for values reported as below limit of detection (1.0%). Hemoglobin F has been previously shown to be upregulated by decitabine in other hematologic disorders- sickle cell disease specifically. The rationale for exploring it in this study was to evaluate its potential utility as a biomarker of drug effect/PD marker."|Cycle 1, Day 1|Four patients had missing data.||percentage of HbF||95% Confidence Interval|Mean
858813|NCT00095784|Secondary|CXCR4|CXCR4 gene expression level measured by real-time RT_PCR. Ratio of CXCR4 vs a housekeeping gene (i.e., ABL)|Cycle 2, Day 12|Eleven patients had missing data.||ratio||95% Confidence Interval|Geometric Mean
858814|NCT00095784|Secondary|CXCR4|CXCR4 gene expression level measured by real-time RT_PCR. Ratio of CXCR4 vs a housekeeping gene (i.e., ABL)|Cycle 2, Day 5|Seven patients had missing data.||ratio||95% Confidence Interval|Geometric Mean
858815|NCT00095784|Secondary|CXCR4|CXCR4 gene expression level measured by real-time RT_PCR. Ratio of CXCR4 vs a housekeeping gene (i.e., ABL)|Cycle 2, Day 1|Seven patients had missing data.||ratio||95% Confidence Interval|Geometric Mean
858816|NCT00095784|Secondary|CXCR4|CXCR4 gene expression level measured by real-time RT_PCR. Ratio of CXCR4 vs a housekeeping gene (i.e., ABL)|Cycle 1, Day 12|Three patients had missing data.||ratio||95% Confidence Interval|Geometric Mean
858817|NCT00095784|Secondary|CXCR4|CXCR4 gene expression level measured by real-time RT_PCR. Ratio of CXCR4 vs a housekeeping gene (i.e., ABL)|Cycle 1, Day 5|Three patients had missing data.||ratio||95% Confidence Interval|Geometric Mean
858818|NCT00095784|Secondary|CXCR4|CXCR4 gene expression level measured by real-time RT_PCR. Ratio of CXCR4 vs a housekeeping gene (i.e., ABL)|Cycle 1, Day 1|Four patients had missing data.||ratio||95% Confidence Interval|Geometric Mean
858819|NCT00095784|Secondary|CD34+ Cells|CD34 positive(+) cells are determined by flow immunostaining and light scatter in peripheral blood. Samples are then analyzed by flow cytometry, and CD34+ cells quantitated after 75,000 CD45 events are studied. (At least 75,000 CD45 events must be studied to ensure accuracy of the assay). Absolute numbers are determined by multiplying the % CD34+ cells by the total white blood cell count obtained on a CBC that is processed simultaneously.|Cycle 2, Day 12|Six patients had missing data.||cells x 10^6/L||95% Confidence Interval|Geometric Mean
858820|NCT00095784|Secondary|CD34+ Cells|CD34 positive(+) cells are determined by flow immunostaining and light scatter in peripheral blood. Samples are then analyzed by flow cytometry, and CD34+ cells quantitated after 75,000 CD45 events are studied. (At least 75,000 CD45 events must be studied to ensure accuracy of the assay). Absolute numbers are determined by multiplying the % CD34+ cells by the total white blood cell count obtained on a CBC that is processed simultaneously.|Cycle 2, Day 5|Six patients had missing data.||cells x 10^6/L||95% Confidence Interval|Geometric Mean
858821|NCT00095784|Secondary|CD34+ Cells|CD34 positive(+) cells are determined by flow immunostaining and light scatter in peripheral blood. Samples are then analyzed by flow cytometry, and CD34+ cells quantitated after 75,000 CD45 events are studied. (At least 75,000 CD45 events must be studied to ensure accuracy of the assay). Absolute numbers are determined by multiplying the % CD34+ cells by the total white blood cell count obtained on a CBC that is processed simultaneously.|Cycle 2, Day 1|Five patients had missing data.||cells x 10^6/L||95% Confidence Interval|Geometric Mean
858822|NCT00095784|Secondary|CD34+ Cells|CD34 positive(+) cells are determined by flow immunostaining and light scatter in peripheral blood. Samples are then analyzed by flow cytometry, and CD34+ cells quantitated after 75,000 CD45 events are studied. (At least 75,000 CD45 events must be studied to ensure accuracy of the assay). Absolute numbers are determined by multiplying the % CD34+ cells by the total white blood cell count obtained on a CBC that is processed simultaneously.|Cycle 1, Day 12|Three patients had missing data.||cells x 10^6/L||95% Confidence Interval|Geometric Mean
858823|NCT00095784|Secondary|CD34+ Cells|CD34 positive(+) cells are determined by flow immunostaining and light scatter in peripheral blood. Samples are then analyzed by flow cytometry, and CD34+ cells quantitated after 75,000 CD45 events are studied. (At least 75,000 CD45 events must be studied to ensure accuracy of the assay). Absolute numbers are determined by multiplying the % CD34+ cells by the total white blood cell count obtained on a CBC that is processed simultaneously.|Cycle 1, Day 5|One patient had missing data.||cells x 10^6/L||95% Confidence Interval|Geometric Mean
858824|NCT00095784|Secondary|CD34+ Cells|CD34 positive(+) cells are determined by flow immunostaining and light scatter in peripheral blood. Samples are then analyzed by flow cytometry, and CD34+ cells quantitated after 75,000 CD45 events are studied. (At least 75,000 CD45 events must be studied to ensure accuracy of the assay). Absolute numbers are determined by multiplying the % CD34+ cells by the total white blood cell count obtained on a CBC that is processed simultaneously.|Cycle 1, Day 1|One patient had missing data.||cells x 10^6/L||95% Confidence Interval|Geometric Mean
858825|NCT00095784|Primary|Incidence of Toxicities, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0|Percentage of patients experiencing any toxicity, any grade level. Additional details on adverse events are reported in Adverse Events section.|Up to 30 days of last dose of decitabine|||percentage of patients||95% Confidence Interval|Number
858826|NCT00095784|Primary|Response Rate (Complete Response, Partial Response, or Hematologic Improvement.|"Complete response is normalization of counts and transfusion-independence.
Partial response is hemoglobin increase to normal levels, multilineage improvement including absolute neutrophil count (ANC) and/or platelets.
Hematologic improvement is red cell transfusion-independence or >50% increase in platelet levels."|Up to 36 weeks (6 cycles)|Two patients were non-evaluable for response.||percentage of participants||90% Confidence Interval|Number
858827|NCT00070499|Secondary|Toxicity|Number of patients with Grade 3-5 adverse events that are related to study drug by given type of adverse event|Patients were assessed for adverse events monthly every 4 weeks for the first year, every 6 months for years 2 and 3, and annually for years 4 and 5.|Eligible patients who started therapy||Participants with a given type of AE|||Number
858828|NCT00070499|Secondary|Two Year Relapse-free Survival|Relapse-free survival is measured from the date of documented (possibly unconfirmed) hematologic complete remission until loss of hematologic complete remission or death from any cause. Observations are censored at the date of last contact for patients last known to be alive with report of loss of hematologic complete remission.|every 3 months for the first year, every six months for years 2 and 3, annually for years 4 and 5|Eligible, treated patients who achieved a hematologic complete remission||Percent of population|||Number
858829|NCT00070499|Secondary|2-year Overall Survival (OS)|Overall survival was measured from the date of registration to study until death from any cause with observations censored at the date of last contact for patients last known to be alive.|Every three months for the first year, every six months in years 2 and 3, and annually for years 4 and 5|All eligible patients who were treated||Percent of population|||Number
858830|NCT00070499|Secondary|Hematologic Response|Hematologic response assesses whether patients' blood counts return to normal|1 month after starting treatment|Eligible, treated patients who were evaluable for hematologic response||participants|||Number
858831|NCT00070499|Primary|Molecular Response Rate at 12 Months|Median value of baseline bcr-abl/bcr ratio from pretreatment was used as the baseline value for assessing each patient's molecular response. Molecular response criteria were: 1) not failed treatment on or before 12-month evaluation; 2) met criteria for hemalotogic response; 3) bcr-abl/bcr ration at 12-months must be 10,000 times smaller than the pretreatment ratio.|pretreatment and after 12 months of treatment|Patients with follow-up specimens assayed by reverse transcription polymerase chain reaction (RT-PCR)||participants|||Number
858832|NCT00060528|Secondary|The Number of Participants With Adverse Events|Here are the total number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|77.5 months|||Participants|||Count of Participants
858833|NCT00060528|Secondary|Overall Survival|Overall survival is defined as the date of on-study to the date of death from any cause or last follow-up.|50 months|||Months||Full Range|Median
858834|NCT00060528|Secondary|Number of Participants With an Objective Response|Objective response is determined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria defined as: measurable disease (at least one measurable lesion), measurable lesions (lesions that can be accurately measured in at least one dimension with longest diameter >/= 20 mm using conventional techniques or >/= 10 mm with spiral CT scan. Non-measurable lesions (all other lesions, including small lesions (longest diameter < 20 mm with conventional techniques or < 10 mm with spiral CT scan), i.e. bone lesions, leptomeningeal disease, ascites, pleural/pericardial effusion...|53 months|All 12 participants with measurable disease were evaluated.||Participants|||Count of Participants
858835|NCT00060528|Secondary|Percent of Participants With a Decrease (i.e. Greater Than or Equal to 30%) in PSA Levels|PSA level at the time treatment is initiated compared to the PSA level at Day 85 and monthly thereafter while the patient continues on trial)|53 months|PSA was taken at multiple time points and proportion of patients (pts) who had a decrease in PSA of at least 30% was reported. This is standard reporting procedures for tumor markers (proportion of patients with a response);similar to RECIST reporting where there may be multiple scans obtained but one reports the proportion of pts with a response||Percentage of participants|||Number
858836|NCT00060528|Primary|Number of Participants With an Immune Response|Immune response is defined as an enhanced PSA specific T-cell immune response greater than or equal to twofold post-vaccination. Peripheral blood mononuclear cells (PBMCs) were collected by apheresis prior to treatment with vaccination and after approximately three months of therapy.|48 months|||Participants|||Count of Participants
858837|NCT02647944|Secondary|Gastric Accommodation Volume at 16 Weeks|Change between postprandial and fasting whole gastric volume by 99mTc-SPECT Imaging. A noninvasive SPECT method was used to measure gastric volume during fasting and 32 min after a liquid nutritional supplement meal. Subjects reported to the clinic after an overnight fast. 99mTC was given by an intravenous injection in the forearm. The first fasting scan was obtained, and the study medication was given s.c. After 10 min, a 2nd fasting post medication scan was obtained, and the meal consumed; then two serial postprandial scans were obtained. Each scan required 9-12 min. Tomographic images of the gastric wall were obtained throughout the long axis of the stomach using a dual-head gamma camera that rotates around the body. This allows assessment of the radiolabeled circumference of the gastric wall, rather than the intragastric content.|16 weeks (approximately 1 hour after 99mTC injection)|Intent to treat analysis; data were imputed for the 5 participants who dropped out.||mL||Inter-Quartile Range|Median
858838|NCT02647944|Secondary|Gastric Postprandial Volume at 16 Weeks|Gastric fasting volume was measured by single photon emission computed tomography (SPECT) imaging of the stomach after intravenous injection of 99mTC-pertechnetate, which is taken up by the gastric mucosa.|16 weeks|Intent to treat analysis; data were imputed for the 5 participants who dropped out.||mL||Inter-Quartile Range|Median
858839|NCT02647944|Secondary|Gastric Fasting Volume at 16 Weeks|Gastric fasting volume was measured by single photon emission computed tomography (SPECT) imaging of the stomach after intravenous injection of 99mTC-pertechnetate, which is taken up by the gastric mucosa.|16 weeks|Intent to treat analysis; data were imputed for the 5 participants who dropped out.||mL||Inter-Quartile Range|Median
858840|NCT02647944|Secondary|Satiation Maximum Tolerated Volume at 16 Weeks|After drinking Ensure, participants recorded their sensations every 5 minutes using a numerical scale from 0 to 5, with level 0 being no symptoms, level 3 corresponding to fullness sensation after a typical meal and level 5 corresponding to the maximal tolerated volume (maximum or unbearable fullness/satiation).|16 weeks|Intent to treat analysis; data were imputed for the 5 participants who dropped out.||mL||Inter-Quartile Range|Median
858841|NCT02647944|Secondary|Satiation Volume to Fullness at 16 Weeks|After drinking Ensure, participants recorded their sensations every 5 minutes using a numerical scale from 0 to 5, with level 0 being no symptoms, level 3 corresponding to fullness sensation after a typical meal and level 5 corresponding to the maximal tolerated volume (maximum or unbearable fullness/satiation).|16 weeks|Intent to treat analysis; data were imputed for the 5 participants who dropped out.||mL||Inter-Quartile Range|Median
858842|NCT02647944|Secondary|Satiety by Buffet Meal, Total Calories Ingested at 16 Weeks|"Satiety (a measure of appetite) was appraised by free feeding buffet meal consisting of standard foods of known nutrient composition. The total amount of food consumed was analyzed by the study dietitian."|16 weeks|Intent to treat analysis; data were imputed for the 5 participants who dropped out.||kcal||Inter-Quartile Range|Median
858843|NCT02647944|Secondary|Weight Change at 16 Weeks|Body weight in kg was measured at 16 weeks and compared to baseline.|baseline, 16 weeks|Intent to treat analysis; data were imputed for the 5 participants who dropped out.||kg||Inter-Quartile Range|Median
858844|NCT02647944|Secondary|Weight Change at 5 Weeks|Body weight in kg was measured at 5 weeks and compared to baseline.|baseline, 5 weeks|Intent to treat analysis; data were imputed for the 5 participants who dropped out.||kg||Inter-Quartile Range|Median
858845|NCT02647944|Primary|Gastric Emptying of Solids Half-time (T1/2) at 16 Weeks|Gastric emptying of solids was assessed by scintigraphy using a 320 Kcal 99mTc-radiolabeled egg, solid-liquid meal. Gastric Emptying Half-time was the linear interpretation of time to when 50% of radiolabeled meal emptied from the stomach.|16 weeks|Intent to treat analysis; data were imputed for the 5 participants who dropped out.||minutes||Inter-Quartile Range|Median
858846|NCT02647944|Primary|Gastric Emptying of Solids Half-time (T1/2) at 5 Weeks|Gastric emptying of solids was assessed by scintigraphy using a 320 Kcal 99mTc-radiolabeled egg, solid-liquid meal. Gastric Emptying Half-time was the linear interpretation of time to when 50% of radiolabeled meal emptied from the stomach.|5 weeks|Intent to treat analysis; data were imputed for the 5 participants who dropped out.||minutes||Inter-Quartile Range|Median
858847|NCT02609672|Secondary|Change in Cardiovascular Fitness|Cardiovascular fitness will be calculated using the Single Stage Treadmill Walking Test. Predictions of VO2max will be made from heart rate (measured with a heart rate monitor), walking speed, age and gender.|Week 1 and Week 13|Due to equipment problems, 2 participants from the Exercise Group were not able to complete the Single Stage Treadmill Walking Test.||Change in ml/kg/min||Standard Deviation|Mean
858848|NCT02609672|Secondary|Change in Isometric Knee and Hip Extensor and Flexor Strength|The peak torque developed during knee and hip extension and flexion during a maximum isometric contraction will be measured by use of a Biodex System 2 isokinetic dynamometer. Data will be presented as Nm/kg (torque/body mass).|Week 1 and Week 13|||Change in Nm/kg||Standard Deviation|Mean
858849|NCT02609672|Secondary|Change in Grip Strength (Relative)|Grip strength will be assessed using a Jamar hand dynamometer. The hand dynamometer will be set to a fixed position and all values of grip force will be expressed in kg/kg (grip force/body mass).|Week 1 and Week 13|||Change in kg/kg||Standard Deviation|Mean
858850|NCT02609672|Secondary|Change in Grip Strength (Absolute)|Grip strength will be assessed using a Jamar hand dynamometer. The hand dynamometer will be set to a fixed position and all values of grip force will be expressed in kg.|Week 1 and Week 13|||Change in kg||Standard Deviation|Mean
858851|NCT02609672|Secondary|Change in Depression Status|Depression will be assessed with the Centre of Epidemiological Studies Depression (CES-D) Scale, a 20-item scale developed for the general population with emphasis on affect. Elements of affect include mood, guilt, worthlessness, helplessness, appetite, and sleep. Each item is scored from 0 (rarely or none of the time), to 3 (most of the time). The items are summed to produce a total score between 0 and 60 with a score of 16 or higher indicating depression.|Week 1 and Week 13|||Change in scores on a scale||Standard Deviation|Mean
858896|NCT02302092|Secondary|Number of Participants With Clinically Significant Change in Vital Signs|Vital signs included body temperature (axillary measurement), diastolic and systolic blood pressure (5 minutes), respiratory rate, and pulse (bpm).|Day 1 up to Day 21|The safety population included all participants who received any dose of planned study medication.||participants|||Number
858852|NCT02609672|Secondary|Change in Arthritis-related Self-efficacy|The Arthritis Self-Efficacy Scale (ASES) measures arthritis-specific beliefs regarding perception of performance on certain tasks to cope with the disease. The ASES is measured using 20 questions on a 10-100 scale with respect to three main areas: pain management (5 questions), physical function (9 questions), and other symptoms (6 questions). Each question is scored from 10 (very uncertain), to 100 (very certain), in 10-point increments. The minimum score for each subscale is 10, and the maximum score for each subscale is 100. The scores from each subscale are averaged to produce a normalized total score. Scores closer to 100 indicate greater certainty that a participant can cope with a particular task as a consequence of their disease.|Week 1 and Week 13|||Change in scores on a scale||Standard Deviation|Mean
858853|NCT02609672|Secondary|Change in Mobility Performance (Timed Up and Go Test)|Mobility performance will be measured using the Timed Up and Go Test. This test measures the time taken to rise from a standard chair with arm rests, walk 3 metres, and return to a seated position. This measure has produced reliable and valid data in persons with knee OA.|Week 1 and Week 13|||Change in Seconds||Standard Deviation|Mean
858854|NCT02609672|Secondary|Change in Mobility Performance (30-second Chair Stand Test)|Mobility performance will be measured using the 30-second Chair Stand Test. This test measures the number of times participants can rise and lower from a standard height chair, without using arm rests, in a 30-second period.This measure has produced reliable and valid data in persons with knee OA.|Week 1 and Week 13|||Change in number of sit-to-stand cycles||Standard Deviation|Mean
858855|NCT02609672|Secondary|Change in Mobility Performance (Stair Descent)|Mobility performance will be measured using the Stair Descent Test. For this test, the time taken to descend nine stairs is recorded in seconds. This measure has produced reliable and valid data in persons with knee OA.|Week 1 and Week 13|||Change in Seconds||Standard Deviation|Mean
858856|NCT02609672|Secondary|Change in Mobility Performance (Stair Ascent)|Mobility performance will be measured using the Stair Ascent Test. For this test, the time taken to ascend nine stairs is recorded in seconds. This measure has produced reliable and valid data in persons with knee OA.|Week 1 and Week 13|||Change in Seconds||Standard Deviation|Mean
858857|NCT02609672|Secondary|Change in Mobility Performance (40 Metre Walk Test)|Mobility performance will be measured using the 40 Metre Walk Test. This test measures the time taken to complete a fast-paced 40 metre walk. The time taken to walk 40 metres is recorded in seconds. This measure has produced reliable and valid data in persons with knee OA.|Week 1 and Week 13|||Change in Seconds||Standard Deviation|Mean
858858|NCT02609672|Secondary|Change in Mobility Performance (Six-Minute Walk Test)|Mobility performance will be measured using the Six-Minute Walk Test (6MWT). For this test, participants are instructed to walk as far as possible in 6 minutes. The distance covered in 6 minutes is recorded in metres. This measure has produced reliable and valid data in persons with knee OA.|Week 1 and Week 13|||Change in Metres||Standard Deviation|Mean
858859|NCT02609672|Secondary|Change in Resilience|Resilience will be measured using the Resilience Scale 25 Survey, which is a 25-item questionnaire designed to evaluate a participants ability to adapt to stress and adversity. The test is scored out of 175 (scores ranging from 25 to 175), with higher scores indicating higher resilience.|Week 1 and Week 13|||Change in scores on a scale||Standard Deviation|Mean
858860|NCT02609672|Secondary|Change in Self-reported Knee and Hip Pain|Change in self-reported knee and hip pain will be assessed with 3 valid and reliable questionnaires: the Knee injury and Osteoarthritis Outcome Score (KOOS), the Hip disability and Osteoarthritis Outcome Score (HOOS), and the Intermittent and Constant Osteoarthritis Pain (ICOAP) score. The KOOS and HOOS pain scores represent a normalized score from 0 (extreme symptoms) to 100 (no symptoms). KOOS and HOOS scores closer to 100 indicate fewer symptoms. The ICOAP consists of two sub-scales: constant pain (5 items) and intermittent pain (6 items). The score from each subscale represents a normalized score from 0 (no pain) to 100 (extreme pain). ICOAP scores closer to 0 indicate less pain. The items from each subscale are averaged to produce a normalized ICOAP total score, ranging from 0 (no pain) to 100 (extreme pain).|Week 1 and Week 13|||Change in scores on a scale||Standard Deviation|Mean
858861|NCT02609672|Primary|Change in Lower Extremity Function|The Lower Extremity Function Scale (LEFS) consists of 20 items, on an adjectival scale, that assess difficulty during mobility tasks ranging from transfers to running. Each item is scored from 0 (extreme difficulty or unable to perform activity), to 4 (no difficulty to perform activity). The minimum possible score is 0, and the maximum possible score is 80. Scores closer to 80 represent better self-reported physical function. It is reliable and valid in knee OA and has superior sensitivity to change compared to similar measures.|Week 1 and Week 13|||Change in scores on a scale||Standard Deviation|Mean
858862|NCT02517515|Secondary|Percentage of Participants With Post-treatment Relapse by Post-treatment Week 24|Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 24 weeks after the last dose of active study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment.|From the end of treatment through 24 weeks after the last dose of active study drug|All participants who received at least 1 dose of active study drug, completed treatment, and had HCV RNA <LLOQ at the final treatment visit, who had HCV RNA data available during the SVR24 period.||percentage of participants||95% Confidence Interval|Number
858863|NCT02517515|Secondary|Percentage of Participants With Post-treatment Relapse by Post-treatment Week 12|Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of active study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment.|From the end of treatment through 12 weeks after the last dose of active study drug|All participants who received at least 1 dose of active study drug, completed treatment, and had HCV RNA <LLOQ at the final treatment visit, who had HCV RNA data available during the SVR12 period.||percentage of participants||95% Confidence Interval|Number
858864|NCT02517515|Secondary|Percentage of Participants With On-treatment Virologic Failure|On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during active treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during active treatment; or all on-treatment values of HCV RNA ≥ LLOQ with at least 6 weeks of active treatment.|up to 12 weeks|All participants who received at least 1 dose of active study drug.||percentage of participants||95% Confidence Interval|Number
858865|NCT02517515|Primary|Percentage of Participants With Sustained Virologic Response 24 Weeks Post-treatment (SVR24)|SVR24 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of active study drug. The primary efficacy endpoint was superiority of the percentage of treatment-naïve and treatment-experienced HCV subgenotype 1b (GT1b)-infected participants treated with 3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 once daily] and dasabuvir [250 mg twice daily]) who achieved SVR24 compared with the historical control rate for comparable patients treated with telaprevir (TVR) plus pegylated interferon (pegIFN) and RBV.|24 weeks after the last actual dose of active study drug|All treatment-naïve and treatment-experienced participants who received at least 1 dose of active study drug; participants with missing data after backward imputation were counted as nonresponders.||percentage of participants||95% Confidence Interval|Number
858866|NCT02517515|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of active study drug. The primary efficacy endpoint was superiority of the percentage of treatment-naïve and treatment-experienced HCV subgenotype 1b (GT1b)-infected participants treated with 3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 once daily] and dasabuvir [250 mg twice daily]) who achieved SVR12 compared with the historical control rate for comparable patients treated with telaprevir (TVR) plus pegylated interferon (pegIFN) and RBV.|12 weeks after the last actual dose of active study drug|All treatment-naïve and treatment-experienced participants who received at least 1 dose of active study drug; participants with missing data after backward imputation were counted as nonresponders.||percentage of participants||95% Confidence Interval|Number
858867|NCT02474082|Secondary|Percentage of Participants With Short Form 36 (SF-36) Response at Week 4, 16 and 24|"SF-36 is a generic indicator of health status for use in population surveys and evaluative studies of health policy. The SF-36 included 36 items in a Likert-type or forced-choice format measured on eight dimensions. The scores for each domain range from 0 to 100, with high scores indicating a better status. SF-36 responder is defined as subject reaching at least an improvement of minimum important difference (MID). The SF-36 measure dimensions and their MID includes:
Physical Functioning:4.3
Role-Physical: 3.4
Bodily Pain: 6.2
General Health: 7.2
Vitality: 6.2
Social Functioning: 6.9
Role-Emotional: 4.5
Mental Health: 6.2
Two component scores and their MID which were derived from the above mentioned 8 domains includes-:
Physical component summary: 3.4
Mental component summary: 4.6"|Week 4, 16 and 24|The analysis was performed on FAS population. Here 'number analyzed' signifies the participants evaluable for SF-36 response at week 4, 16 and 24||Percentage of participants|||Number
858868|NCT02474082|Secondary|Percentage of Participants With DLQI 0/1 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|DLQI is a 10-item general dermatology disability index designed to assess health-related quality of life in adult subjects with skin diseases such as eczema, psoriasis, acne, and viral. The measure was self-administered and included domains of daily activities, leisure, personal relationships, symptoms and feelings, treatment, and work/school. Each item had four response categories ranging from 0 (not at all) to 3 (very much). “Not relevant” was also a valid response and was scored as 0. The DLQI total score was a sum of the 10 questions. Scores ranged from 0 to 30, with higher scores indicating greater impairment in health related quality of life. DLQI 0/1 response was the achievement of a DLQI score of 0 or 1.|Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|The analysis was performed on FAS population.||Percentage of participants|||Number
858869|NCT02474082|Secondary|Dermatology Life Quality Index (DLQI) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|DLQI is a 10-item general dermatology disability index designed to assess health-related quality of life in adult subjects with skin diseases such as eczema, psoriasis, acne, and viral. The measure was self-administered and included domains of daily activities, leisure, personal relationships, symptoms and feelings, treatment, and work/school. Each item had four response categories ranging from 0 (not at all) to 3 (very much). “Not relevant” was also a valid response and was scored as 0. The DLQI total score was a sum of the 10 questions. Scores ranged from 0 to 30, with higher scores indicating greater impairment in health related quality of life.|Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|The analysis was performed on FAS population. Here 'number analyzed' signifies the participants evaluable for DLQI at week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24.||Score on a scale||Standard Deviation|Mean
858870|NCT02474082|Secondary|Percentage of Participants With IGA Mod. 2011 0/1-response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|The IGA mod 2011 scale has been developed based on a previous version of the scale used in secukinumab phase II studies in collaboration with health authorities, in particular the FDA. The explanations/descriptions of the points on the scale have been improved to ensure appropriate differentiation between the points. The IGA mod 2011 used in this study is static, i.e. it refers exclusively to the subject’s disease state at the time of the assessments, and does not attempt a comparison with any of the subject’s previous disease states, whether at baseline or at a previous visit.IGA mod 2011 has a scale of 0-4 with the lower scores correlating to better performance. A score of 0= clear skin, 1= almost clear skin, 2=mild, 3=moderate,4=severe. IGA 0/1 responders: who achieved score of 0/1 and improved by at least 2 points on the IGA scale compared to baseline.|Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|The analysis was performed on FAS population.||Percentage of participants|||Number
858871|NCT02474082|Secondary|Number of Participants With Investigator’s Global Assessment (IGA Mod 2011) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|IGA mod 2011 is a global static severity rating scale referring exclusively to the participant’s disease state at the time of the assessments and don’t attempt comparison with participant’s any previous disease states at baseline or visit. IGA mod 2011 has a scale of 0-4 with the lower scores correlating to better performance. Scores used were: 0/Clear: no signs of psoriasis, Post-inflammatory hyperpigmentation may be present; 1/almost clear: Normal to pink coloration of lesions/no thickening/no to minimal focal scaling; 2/Mild: Pink to light red coloration/just detectable to mild thickening/predominantly fine scaling; 3/Moderate: Dull bright red, clearly distinguishable erythema/clearly distinguishable to moderate thickening/moderate scaling; 4/Severe: Bright to deep dark red coloration/severe thickening with hard edges/severe or coarse scaling covering almost all or all lesions.|Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|The analysis was performed in FAS population. Here 'number analyzed' signifies the participants evaluable for IGA mod 2011 at week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24.||Participants|||Count of Participants
858872|NCT02474082|Secondary|Percentage of Participants Achieving Nail Psoriasis Severity Index (NAPSI) 100 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|NAPSI was used to assess psoriatic nail involvement in participants with nail psoriasis. NAPSI score was calculated as total of nail matrix and nail bed score, ranging from 0-8 per nail. Total NAPSI score ranges from 0 to 80 for all fingernails. Each nail was divided with imaginary horizontal and longitudinal lines into quadrants. Each nail was given a score of 0 - 4 for nail matrix and nail bed psoriasis 0–4 (0: for none, 1: for 1 quadrant, 2: for 2 quadrants, 3: for 3 quadrants, 4: for all 4 quadrants), based on presence of any feature of nail psoriasis in that quadrant. Nail matrix psoriasis feature includes: pitting, leukonychia red spots in lunula, crumbling. Nail bed psoriasis feature includes: onycholysis, splinter hemorrhages, subungual hyperkeratosis, “oil drop” (salmon patch dyschroma). NPASI 100 responders were participants who PASI 100 responders were participants who achieved complete clearance of psoriasis.|Baseline, Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|The analysis was performed on FAS population. Here 'number analyzed' signifies the participants evaluable for NAPSI 100 response at week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24.||Percentage of participants|||Number
858873|NCT02474082|Secondary|Percentage of Participants Achieving Nail Psoriasis Severity Index (NAPSI) 90 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|NAPSI was used to assess psoriatic nail involvement in participants with nail psoriasis. NAPSI score was calculated as total of nail matrix and nail bed score, ranging from 0-8 per nail. Total NAPSI score ranges from 0 to 80 for all fingernails. Each nail was divided with imaginary horizontal and longitudinal lines into quadrants. Each nail was given a score of 0 - 4 for nail matrix and nail bed psoriasis 0–4 (0: for none, 1: for 1 quadrant, 2: for 2 quadrants, 3: for 3 quadrants, 4: for all 4 quadrants), based on presence of any feature of nail psoriasis in that quadrant. Nail matrix psoriasis feature includes: pitting, leukonychia red spots in lunula, crumbling. Nail bed psoriasis feature includes: onycholysis, splinter hemorrhages, subungual hyperkeratosis, “oil drop” (salmon patch dyschroma). NPASI 90 responders were participants who achieved >=90% improvement (reduction) in NPASI score compared to baseline.|Baseline, Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|The analysis was performed on FAS population. Here 'number analyzed' signifies the participants evaluable for NAPSI 90 response at week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24.||Percentage of participants|||Number
858874|NCT02474082|Secondary|Percentage of Participants Achieving Nail Psoriasis Severity Index (NAPSI) 75 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|NAPSI was used to assess psoriatic nail involvement in participants with nail psoriasis. NAPSI score was calculated as total of nail matrix and nail bed score, ranging from 0-8 per nail. Total NAPSI score ranges from 0 to 80 for all fingernails. Each nail was divided with imaginary horizontal and longitudinal lines into quadrants. Each nail was given a score of 0 - 4 for nail matrix and nail bed psoriasis 0–4 (0: for none, 1: for 1 quadrant, 2: for 2 quadrants, 3: for 3 quadrants, 4: for all 4 quadrants), based on presence of any feature of nail psoriasis in that quadrant. Nail matrix psoriasis feature includes: pitting, leukonychia red spots in lunula, crumbling. Nail bed psoriasis feature includes: onycholysis, splinter hemorrhages, subungual hyperkeratosis, “oil drop” (salmon patch dyschroma). NPASI 75 responders were participants who achieved >=75% improvement (reduction) in NPASI score compared to baseline.|Baseline, Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|The analysis was performed on FAS population. Here 'number analyzed' signifies participants evaluable for NAPSI 75 at week 1, 2, 3, 4, 5, 6, 8,12,16, 20 and 24.||Percentage of participants|||Number
858875|NCT02474082|Secondary|Percentage of Participants Achieving Nail Psoriasis Severity Index (NAPSI) 50 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|NAPSI was used to assess psoriatic nail involvement in participants with nail psoriasis. NAPSI score was calculated as total of nail matrix and nail bed score, ranging from 0-8 per nail. Total NAPSI score ranges from 0 to 80 for all fingernails. Each nail was divided with imaginary horizontal and longitudinal lines into quadrants. Each nail was given a score of 0 - 4 for nail matrix and nail bed psoriasis 0–4 (0: for none, 1: for 1 quadrant, 2: for 2 quadrants, 3: for 3 quadrants, 4: for all 4 quadrants), based on presence of any feature of nail psoriasis in that quadrant. Nail matrix psoriasis feature includes: pitting, leukonychia red spots in lunula, crumbling. Nail bed psoriasis feature includes: onycholysis, splinter hemorrhages, subungual hyperkeratosis, “oil drop” (salmon patch dyschroma). NPASI 50 responders were participants who achieved >=50% improvement (reduction) in NPASI score compared to baseline.|Baseline, Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|The analysis was performed on FAS population. Here ‘number analyzed’ signifies participants evaluable for NAPSI 50 at week 1, 2, 3, 4, 5, 6, 7,12,16, 20 and 24.||Percentage of participants|||Number
858876|NCT02474082|Secondary|Body Surface Area (BSA) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|The Body surface area (BSA) affected by plaque-type psoriasis was the total of percentages of areas affected, including head, trunk, upper limbs and lower limbs. Each reported percentage was multiplied by its respective body region corresponding factor (head = 0.1, trunk = 0.3, upper limbs = 0.2, lower limbs = 0.4). The resulting four percentages were added to estimate the total BSA affected by plaque-type psoriasis.|Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|The analysis was performed in FAS population. Here 'number analyzed' signifies participants evaluable for BSA at week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24.||Percentage of area||Standard Deviation|Mean
858877|NCT02474082|Secondary|Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 100 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|PASI score is an average degree of severity of signs in head [H], trunk [T], upper limbs [U] and lower limbs [L], assessed separately for erythema [E], thickening (plaque elevation, induration) [I], and scaling (desquamation) [D]. Area [A] covered by lesions on each body region was estimated as a percentage (%) of total area of that particular body region and was assigned a score of 0=0%; 1=1-9%; 2=10-29%; 3=30-49%; 4=50-69%; 5=70-89%; 6=90-100%. The head and neck, upper limbs, trunk and lower limbs correspond to approximately 10%, 20%, 30% and 40% of the body surface area, respectively. PASI score was calculated as: PASI = 0.1(EH+IH+DH) AH + 0.2(EU+IU+DU) AU + 0.3(ET+IT+DT) AT + 0.4(EL+IL+DL) AL. PASI scores can range from 0 (no signs) to a maximum of 72.0. PASI 100 responders were participants who achieved complete clearance of psoriasis (PASI=0).|Baseline, Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|The analysis was performed in FAS population. Here 'number analyzed' signifies participants evaluable for PASI 100 at week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24.||Percentage of participants|||Number
858897|NCT02302092|Secondary|Number of Participants With Clinically Significant Abnormal Laboratory Values|The number of participants with any markedly abnormal (above or below normal ranges) standard safety laboratory values was collected throughout study.|Day 21|The safety population included all participants who received any dose of planned study medication.||participants|||Number
858878|NCT02474082|Secondary|Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 90 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|PASI score is an average degree of severity of signs in head [H], trunk [T], upper limbs [U] and lower limbs [L], assessed separately for erythema [E], thickening (plaque elevation, induration) [I], and scaling (desquamation) [D]. Area [A] covered by lesions on each body region was estimated as a percentage (%) of total area of that particular body region and was assigned a score of 0=0%; 1=1-9%; 2=10-29%; 3=30-49%; 4=50-69%; 5=70-89%; 6=90-100%. The head and neck, upper limbs, trunk and lower limbs correspond to approximately 10%, 20%, 30% and 40% of the body surface area, respectively. PASI score was calculated as: PASI = 0.1(EH+IH+DH) AH + 0.2(EU+IU+DU) AU + 0.3(ET+IT+DT) AT + 0.4(EL+IL+DL) AL. PASI scores can range from 0 (no signs) to a maximum of 72.0. PASI 90 responders were participants who achieved >=90% improvement (reduction) in PASI score compared to baseline.|Baseline, Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|The analysis was performed in FAS population. Here 'number analyzed' signifies participants evaluable for PASI 90 at week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24.||Percentage of participants|||Number
858879|NCT02474082|Secondary|Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 75 Response at Week 1, 2, 3, 4, 6, 8, 12, 16 and 20|PASI score is an average degree of severity of signs in head [H], trunk [T], upper limbs [U] and lower limbs [L], assessed separately for erythema [E], thickening (plaque elevation, induration) [I], and scaling (desquamation) [D]. Area [A] covered by lesions on each body region was estimated as a percentage (%) of total area of that particular body region and was assigned a score of 0=0%; 1=1-9%; 2=10-29%; 3=30-49%; 4=50-69%; 5=70-89%; 6=90-100%. The head and neck, upper limbs, trunk and lower limbs correspond to approximately 10%, 20%, 30% and 40% of the body surface area, respectively. PASI score was calculated as: PASI = 0.1(EH+IH+DH) AH + 0.2(EU+IU+DU) AU + 0.3(ET+IT+DT) AT + 0.4(EL+IL+DL) AL. PASI scores can range from 0 (no signs) to a maximum of 72.0. PASI 75 responders were participants who achieved >=75% improvement (reduction) in PASI score compared to baseline.|Baseline, Week 1, 2, 3, 4, 6, 8, 12, 16 and 20|The analysis was performed in FAS population. Here 'number analyzed' signifies participants evaluable for PASI 75 at week 1, 2, 3, 4, 6, 8, 12, 16 and 20.||Percentage of participants|||Number
858880|NCT02474082|Secondary|Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 50 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|PASI score is an average degree of severity of signs in head [H], trunk [T], upper limbs [U] and lower limbs [L], assessed separately for erythema [E], thickening (plaque elevation, induration) [I], and scaling (desquamation) [D]. Area [A] covered by lesions on each body region was estimated as a percentage (%) of total area of that particular body region and was assigned a score of 0=0%; 1=1-9%; 2=10-29%; 3=30-49%; 4=50-69%; 5=70-89%; 6=90-100%. The head and neck, upper limbs, trunk and lower limbs correspond to approximately 10%, 20%, 30% and 40% of the body surface area, respectively. PASI score was calculated as: PASI = 0.1(EH+IH+DH) AH + 0.2(EU+IU+DU) AU + 0.3(ET+IT+DT) AT + 0.4(EL+IL+DL) AL. PASI scores can range from 0 (no signs) to a maximum of 72.0. PASI 50 responders were participants who achieved >=50% improvement (reduction) in PASI score compared to baseline.|Baseline, Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|The analysis was performed in FAS population. Here 'number analyzed' signifies participants evaluable for PASI 50 at week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24.||Percentage of participants|||Number
858881|NCT02474082|Primary|Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 75 Response at Week 24|PASI score is an average degree of severity of signs in head [H], trunk [T], upper limbs [U] and lower limbs [L], assessed separately for erythema [E], thickening (plaque elevation, induration) [I], and scaling (desquamation) [D]. Area [A] covered by lesions on each body region was estimated as a percentage (%) of total area of that particular body region and was assigned a score of 0=0%; 1=1-9%; 2=10-29%; 3=30-49%; 4=50-69%; 5=70-89%; 6=90-100%. The head and neck, upper limbs, trunk and lower limbs correspond to approximately 10%, 20%, 30% and 40% of the body surface area, respectively. PASI score was calculated as: PASI = 0.1(EH+IH+DH) AH + 0.2(EU+IU+DU) AU + 0.3(ET+IT+DT) AT + 0.4(EL+IL+DL) AL. PASI scores can range from 0 (no signs) to a maximum of 72.0. PASI 75 responders were participants who achieved >=75% improvement (reduction) in PASI score compared to baseline.|Baseline, Week 24|The analysis was performed in Full analysis set (FAS) population, defined as all randomized participants who received at least one dose of study drug.||Percentage of participants|||Number
858882|NCT02312713|Secondary|Change From Baseline to Month 4 and Change From Baseline to 12 Month in Additional Self-Report Physical Activity Items|Number of minutes per week, on average, they are completing strengthening, stretching, and aerobic exercises. The minimum score is 0, and there is no maximum score; higher scores indicate more weekly activity.|baseline, 4 months, and 12 months|||minutes per week||95% Confidence Interval|Least Squares Mean
858883|NCT02312713|Secondary|Change From Baseline to Month 4 and Change From Baseline to 12 Month in the Physical Activity Scale for the Elderly (PASE)|"The Physical Activity Scale for the Elderly (PASE) is a self-report, 12-item scale that measures level occupational, household, and leisure activity during a one-week period. This scale was particularly developed for use among older adults; although all participants in the proposed study will not be age 65 or over, patients with knee OA typically have more limited physical activity than the general population. Therefore we believe this scale will be more applicable to our participant group than scales that were developed for younger adults.
The typical range for the total PASE score is 0-400, with higher scores indicating greater activity."|baseline, 4 months, and 12 months|||units on a scale||95% Confidence Interval|Least Squares Mean
858884|NCT02312713|Secondary|Change From Baseline to Month 4 and Change From Baseline to 12 Month in the The Brief Fear of Movement Scale|The Brief Fear of Movement Scale is a six item scale for assessing fear of movement in OA. The scale specifically assesses activity avoidance due to pain-related fear of movement. All items are measured on a 4-point scale from “strongly agree” to “strongly disagree.” The score ranges from 0-24 with higher scores indicating more fear of movement.|baseline, 4 months, and 12 months|||units on a scale||95% Confidence Interval|Least Squares Mean
858895|NCT02302092|Secondary|Number of Participants With Clinically Significant Change in Physical Examination Findings|Physical examination consists of examinations of the following body systems: (1) cardiovascular system; (2) dermatologic system (3) ears, nose, throat; (4) extremities; (5) eyes; (6) gastrointestinal system; (7) genitourinary system; (8) lymph nodes; (9) musculoskeletal system; (10) nervous system; (11) respiratory system.|Day 1 up to Day 21|The safety population included all participants who received any dose of planned study medication.||participants|||Number
858885|NCT02312713|Secondary|Change From Baseline to Month 4 and Change From Baseline to 12 Month in The PROMIS Fatigue Instrument|The PROMIS Fatigue instruments evaluate a range of self-reported symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one’s ability to execute daily activities and function normally in family or social roles. Fatigue is divided into the experience of fatigue (frequency, duration, and intensity) and the impact of fatigue on physical, mental, and social activities. It assesses fatigue over the past seven days, This scale includes 8 items, each measured on a 5-point Likert scale. Per PROMIS scoring instructions, raw scores are converted into standardized t-scores with a mean of 50 and standard deviation of 10. T-scores can range from 33.1-77.8; higher scores indicate worse fatigue.|baseline, 4 months, and 12 months|||units on a scale||95% Confidence Interval|Least Squares Mean
858886|NCT02312713|Secondary|Change From Baseline to Month 4 and Change From Baseline to 12 Month in The PROMIS Sleep-related Impairment Instrument|The PROMIS adult sleep related impairment item bank focuses on self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours, and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness. It assesses sleep-related impairment over the past seven days. This scale includes 8 items, each measured on a 5-point Likert scale. Per PROMIS scoring instructions, raw scores are converted into standardized t-scores with a mean of 50 and standard deviation of 10. T-scores can range from 30.5-77.6; higher scores indicate worse sleep impairment.|baseline, 4 months, and 12 months|||units on a scale||95% Confidence Interval|Least Squares Mean
858887|NCT02312713|Secondary|Change From Baseline to Month 4 and Change From Baseline to Month 12 in The Knee Injury and Osteoarthritis Outcome Score (KOOS)|The KOOS is a patient-reported outcome measurement instrument, developed to assess the patient’s opinion about their knee and associated problems. Five KOOS subscale scores were administered: Pain (9 items), Function in daily living (17 items), Function in Sport and Recreation (5 items), and knee-related Quality of Life (4 items). All items are scored on 5-point Likert scales. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale|baseline, 4 months, and 12 months|||units on a scale||95% Confidence Interval|Least Squares Mean
858888|NCT02312713|Secondary|Change From Baseline to Month 4 and Change From Baseline to 12 Month in the Patient Health Questionnaire-8|Depressive symptoms and severity will be assessed using the PHQ-8, a reliable and valid measure of depression71. The PHQ-8 is an eight-item survey derived from the Primary Care Evaluation of Mental Disorders (PRIME-MD) diagnostic tool, and consists of items corresponding to the depression criteria listed in the Diagnostic and Statistics Manual Fourth Edition (DSM-IV). Each of the eight questions is scored as 0 (not at all) to 3 (nearly every day), so that total scores range from 0 to 24, with higher scores indicating more depressive symptoms.|baseline, 4 months, and 12 months|||units on a scale||95% Confidence Interval|Least Squares Mean
858889|NCT02312713|Secondary|Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function- Timed Up and Go|One of 4 tests that objectively assessed physical function. These 4 tests included: unilateral stand time; time to rise from a chair and return to the seated position for 30 seconds; timed up and go- rise from a seated position, walk a short distance and return to seated position; and a 2 minute step test. For this outcome measure, the timed up and go, there are no minimum or maximum scores (participants complete the task as quickly as they are able); shorter (lower) times indicate better function.|baseline, 4 months, and 12 months|||seconds||95% Confidence Interval|Least Squares Mean
858890|NCT02312713|Secondary|Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function - 30 Second Chair Stand|One of 4 tests that objectively assessed physical function. These 4 tests included: unilateral stand time; time to rise from a chair and return to the seated position for 30 seconds; timed up and go- rise from a seated position, walk a short distance and return to seated position; and a 2 minute step test. For this outcome measure, the 30 second chair stand test, the minimum is 0 stands and there is no maximum scale score (participants complete as many stands as they can in 30 seconds; greater numbers of stands indicate better function.|baseline, 4 months, and 12 months|||number of stands from a chair in 30 sec||95% Confidence Interval|Least Squares Mean
858891|NCT02312713|Secondary|Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function- Unilateral Stand Time|One of 4 tests that objectively assessed physical function. These 4 tests included: unilateral stand time; time to rise from a chair and return to the seated position for 30 seconds; timed up and go- rise from a seated position, walk a short distance and return to seated position; and a 2 minute step test. For this outcome measure, the unilateral stand test, scores scan range from 0-10 seconds, with higher time indicating better balance.|baseline, 4 months, and 12 months|||seconds||95% Confidence Interval|Least Squares Mean
858892|NCT02312713|Secondary|Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function - 2 Minute Step Test|One of 4 tests that objectively assessed physical function. These 4 tests included: unilateral stand time; time to rise from a chair and return to the seated position for 30 seconds; timed up and go- rise from a seated position, walk a short distance and return to seated position; and a 2 minute step test. For this outcome measure, the 2 minute step test, the minimum is 0 steps and there is no maximum scale score (participants complete as many steps as they can in 2 minutes); greater steps indicate better function.|baseline, 4 months, and 12 months|||number of steps taken in 2 minutes||95% Confidence Interval|Least Squares Mean
858893|NCT02312713|Secondary|Change From Baseline to Month 4 and Change From Baseline to 12 Month in the Satisfaction With Physical Function Scale|This is a validated, 5-item questionnaire that assesses patients’ satisfaction with their ability to complete basic functional tasks that are often affected by lower extremity OA, including stair-climbing, walking, doing housework (light and heavy, and lifting and carrying). All 5 items are rated on a 7 point scale ranging from Very Dissatisfied (-3) Very Satisfied (+3). The total scale ranges from -15 to +15,with higher scores indicating greater satisfaction with function.|baseline, 4 months, and 12 months|||units on a scale||95% Confidence Interval|Least Squares Mean
858894|NCT02312713|Primary|Change From Baseline to Month 4 and Change From Baseline to 12 Month in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Index Score|Change over time in the primary outcome measure for this study, the WOMAC is a measure of lower extremity pain (5 items), stiffness (2 items), and function (17 items). The scale ranges from 0-96 with higher scores indicating worse symptoms and function.|baseline, 4 months, and 12 months|||units on a scale||95% Confidence Interval|Least Squares Mean
858898|NCT02302092|Secondary|Number of Participants With Serious Adverse Events (SAEs) and Treatment-Emergent-Adverse Events (TEAEs)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A Serious Adverse Event (SAE) A serious is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.|Baseline up to Day 30|The safety population included all participants who received any dose of planned study medication.||participants|||Number
858899|NCT02302092|Secondary|Percentage of Participants With a Superinfection at the EOT and TOC Visits|A urine sample was collected from the participants at the EOT (Days 7 to 14) and TOC (Days 14 to 21) visits to determine the level of uropathogen. Cultures of the urine sample were processed by using a calibrated loop to identify a quantitative count of bacteria, with a lower limit of 10^4 CFU/mL. A superinfection was defined as growth of a uropathogen other than the original pathogen at a level greater than or equal to 10^4 CFU/mL at any time during the course of active therapy.|Baseline, Day 7 to 14 and 14 to 21|Due to premature trial termination and small sample size, data for superinfection due to particular pathogen numbers in different time periods was not determined.|||||
858900|NCT02302092|Secondary|Percentage of Participants With a New Infection at the EOT and TOC Visits|A urine sample was collected from the participants at the EOT (Days 7 to 14) and TOC (Days 14 to 21) visits to determine the level of uropathogen. Cultures of the urine sample were processed by using a calibrated loop to identify a quantitative count of bacteria, with a lower limit of 10^4 CFU/mL. A new infection was defined as the isolation and growth of a uropathogen other than the original pathogen.|Baseline, Days 7 to 14 and 14 to 21|Due to premature trial termination and small sample size, data for new infection due to particular pathogen numbers in different time periods was not determined.|||||
858901|NCT02302092|Secondary|Percentage of Participants With Microbiologic Persistence of the Unique Pathogen at the EOT and TOC Visits|A urine sample was collected from the participants at the EOT (Days 7 to 14) and TOC (Days 14 to 21) visits to determine the level of uropathogen. Cultures of the urine sample was processed by using a calibrated loop to identify a quantitative count of bacteria, with a lower limit of 10^4 CFU/mL. Microbiological response at the TOC visit was be based on the same grades as for the EOT visit. The infection was considered to be persistent if the level of the uropathogen has increased by greater than or equal to 10^4 CFU/mL from the time of study entry to that of the EOT and TOC visits.|Baseline, Days 7 to 14 and 14 to 21|Due to premature trial termination and small sample size, data for persistence of particular pathogen numbers in different time periods was not determined.|||||
858902|NCT02302092|Secondary|Percentage of Participants With Microbiologic Eradication of the Unique Pathogen at the EOT and TOC Visits|A urine sample was collected from the participants at the EOT (Days 7 to 14) and TOC (Day 14 to 21) visits to determine the level of uropathogen. Cultures of the urine sample were processed by using a calibrated loop to identify a quantitative count of bacteria, with a lower limit of 10^4 CFU/mL. Microbiological response at the TOC visit was based on the same grades as for the EOT visit. The infection was considered to be eradicated if all uropathogens isolated at study entry at a level equal to or greater than 10^4 CFU/mL have decreased to less than 10^4 CFU/mL.|Baseline, Days 7 to 14 and 14 to 21|Due to premature trial termination and small sample size, data for eradication for particular pathogen numbers in different time periods was not determined.|||||
858903|NCT02302092|Secondary|Percentage of Participants Who Achieved Clinical Resolution of Symptoms of a cUTI at Visit 3, TOC and Late Follow-up (LFU) Visits|At Visit 3 (Day 3) and at the TOC (Days 14 to 21) and LFU visits (Day 30), the Investigator collected information about each symptom and performed a judgement about the participant's status. Clinical symptoms present at trial entry were considered to be resolved if the participant has no pyuria; no fever; no malaise, flank pain, back pain, and/or costo-vertebral angle pain or tenderness; and no symptoms of dysuria, urinary urgency, urinary frequency, suprapubic discomfort, new urinary incontinence, or worsening of pre-existing incontinence. Resolution of all clinical symptoms of cUTI were assessed relative to baseline.|Baseline, Days 3, 14 to 21 and 30|The micro-ITT population included all participants who were randomized and had a baseline bacterial pathogen on culture of urine that causes UTI against which the investigational drug has antibacterial activity.||percentage of participants|||Number
858904|NCT02302092|Secondary|Percentage of Participants With Microbiological Success at the EOT and Test-of-Cure (TOC) Visits|A urine sample was collected at EOT (Days 7 to 14) and TOC (Days 14 to 21) visits to determine level of uropathogen. Cultures of urine sample were processed by calibrated loop to identify a quantitative count of bacteria, with a lower limit of 10^4 colony forming units per milliliter (CFU/mL). Microbiological success was defined as bacterial uropathogen level of <10^4 CFU/mL. Microbiological response was categorized as:microbiological eradication/persistence/new infection/superinfection. An infection was eradicated if all uropathogens isolated at study entry at a level ≥10^4 CFU/mL have decreased to <10^4 CFU/mL, persistent if level of uropathogen has increased by ≥10^4 CFU/Ml. A new infection, if there is isolation and growth of a uropathogen other than original pathogen and superinfection if there is growth of a uropathogen other than original pathogen at a level ≥10^4 CFU/mL. Microbiological success was assessed relative to baseline.|Baseline, Days 7 to 14 and 14 to 21|The micro-ITT population included all participants who were randomized and had a baseline bacterial pathogen on culture of urine that causes UTI against which the investigational drug has antibacterial activity.||percentage of participants|||Number
858920|NCT02224846|Secondary|Percentage of Participants Achieving Normal Erectile Functioning|Participants achieving a normal erectile functioning (defined as having an IIEF-EF Domain score of >=26) at Month 1 and Month 3.|Month 1, Month 3|All enrolled subjects who fulfill the study entry criteria, receive at least one dose of tadalafil, and have both baseline and postbaseline data.||Percentage of partcipants|||Number
859149|NCT01141712|Secondary|Lymphoma Disease-free Survival|This will be assessed in patients with CR. Patients are considered failure for this end point if they die or if they relapse after complete remission. Patients with no history of relapse or death after complete remission are censored at time of last follow up.|Year 2|No data collected to analyze this outcome measure.|||||
858905|NCT02302092|Primary|Percentage of Participants Who Achieved Resolution of All Clinical Symptoms of a Complicated Urinary Tract Infection (cUTI) at the End of Treatment (EOT) Visit|At the EOT visit (Days 7 to 14), the Investigator collected information about each symptom and performed a judgement about the participant's status. Clinical symptoms present at trial entry were considered to be resolved if the participant has no pyuria; no fever; no malaise, flank pain, back pain, and/or costo-vertebral angle pain or tenderness; and no symptoms of dysuria, urinary urgency, urinary frequency, suprapubic discomfort, new urinary incontinence, or worsening of pre-existing incontinence. Resolution of all clinical symptoms of cUTI were assessed relative to baseline.|Baseline and Days 7 to 14|The micro-intent to treat (ITT) population included all participants who were randomized and had a baseline bacterial pathogen on culture of urine that causes UTI against which the investigational drug has antibacterial activity.||percentage of participants|||Number
858906|NCT02285998|Secondary|Number of Participants With Systemic Reactogenicity|Solicited events of systemic reactogenicity reported during Day 0-7.|Days 0 through 7|Solicited systemic reactogenicity events include subjects who recorded any systemic reaction data.||participants|||Number
858907|NCT02285998|Secondary|Measure of Post-vaccination HAI GMTs|GMT titers for all four antigens in a preselected subset of subjects.|Days 0 through 28|The immunogenicity population includes all randomized subjects at the specific study sites pre-selected for serology who received study vaccine and provided serum samples on Days 0 and 28 for serologic testing.||titer||95% Confidence Interval|Geometric Mean
858908|NCT02285998|Secondary|Number of Participants With Serious Adverse Events (SAEs) and Medically-attended Adverse Events (MAEs)|"Serious adverse events (SAEs) and medically-attended adverse events (MAEs) occurring during the period of follow-up through the influenza season (at least 6 months post-vaccination).
A MAE is an event that prompts an unplanned visit to a medical professional for diagnosis and/or treatment."|Day 0 through and up to 32 weeks post vaccination|The safety population includes all randomized and vaccinated subjects who provided any safety data (solicited or unsolicited) following administration of study vaccine.||participants|||Number
858909|NCT02285998|Secondary|Number of Participants With Unsolicited Adverse Events|Unsolicited adverse events reported in the 28 days following vaccine administration.|Days 0 through 28|The safety population includes all randomized and vaccinated subjects who provided any safety data (solicited or unsolicited) following administration of study vaccine.||participants|||Number
858910|NCT02285998|Secondary|Number of Participants With Local Injection Site Reactogenicity|Solicited events of injection site reactogenicity reported during Day 0-7.|Days 0 through 7|Solicited local reactogenicity events include subjects who recorded any injection site reaction data.||participants|||Number
858911|NCT02285998|Secondary|Percentage of Participants With Seroconversion|Seroconversion rates (SCR) for all four antigens in a preselected subset of subjects.|Days 0 through 28|The immunogenicity population includes all randomized subjects at the specific study sites pre-selected for serology who received study vaccine and provided serum samples on Days 0 and 28 for serologic testing.||percentage of participants||95% Confidence Interval|Number
858912|NCT02285998|Secondary|Number of Participants With rtPCR-confirmed CDC-defined Influenza-Like Illness|rtPCR-confirmed CDC-defined ILI that begins at least 14 days post-vaccination caused by any influenza strain.|14 days post vaccination through and up to 32 weeks post vaccination|The efficacy population includes all randomized subjects who received study vaccine and provided any follow-up for ILI beginning at least 14 days following vaccine administration.||participants|||Number
858913|NCT02285998|Secondary|Number of Participants With Culture-confirmed CDC-defined Influenza-Like Illness|"Culture-confirmed CDC-defined Influenza-Like Illness (ILI) that begins at least 14 days post-vaccination caused by an influenza strain (identified from the same clinical sample) antigenically matched to those in the study vaccines.
CDC-defined ILI is defined as body temperature ≥100°F accompanied by cough and/or sore throat."|14 days post vaccination through and up to 32 weeks post vaccination|The efficacy population includes all randomized subjects who received study vaccine and provided any follow-up for ILI beginning at least 14 days following vaccine administration.||participants|||Number
858914|NCT02285998|Secondary|Number of Participants With Culture-confirmed Influenza-Like Illness|"Culture-confirmed protocol-defined Influenza-Like Illness (ILI) that begins at least 14 days post-vaccination caused by an influenza strain (identified from the same clinical sample) antigenically matched to those strains represented in the study vaccines.
Protocol-defined ILI is defined as at least one of the following respiratory symptoms accompanied by at least one of the following systemic symptoms:
Respiratory symptoms: sore throat, cough, sputm production, wheezing, difficulty breathing Systemic symptoms: fever, chills (shivering), tiredness (fatigue), headache, myalgia (muscle ache)"|14 days post vaccination through and up to 32 weeks post vaccination|The efficacy population includes all randomized subjects who received study vaccine and provided any follow-up for ILI beginning at least 14 days following vaccine administration.||participants|||Number
858915|NCT02285998|Primary|Number of Participants With rtPCR-confirmed Influenza-Like Illness|rtPCR-confirmed, protocol-defined Influenza-Like Illness (ILI) caused by any influenza strain that begins at least 14 days post-vaccination|14 days post vaccination through and up to 32 weeks post vaccination|The efficacy population includes all randomized subjects who received study vaccine and provided any follow-up for ILI beginning at least 14 days following vaccine administration.||participants|||Number
858916|NCT02224846|Secondary|"Percentage of Participants With Yes Responses to Global Assessment Questions(GAQ)1 and GAQ2"||Month 24||09/2018||||
858917|NCT02224846|Secondary|"Percentage of Participants With Yes Responses to Global Assessment Questions(GAQ)1 and GAQ2"|"Participants with “yes” responses to GAQ Question 1 (GAQ1) and GAQ Question 2 (GAQ2) of the GAQ questionnaire at Month 3 and Month 12.
GAQ1: Has the treatment you have been taking during this study improved your erections? GAQ-2: “If yes, has the treatment improved your ability to engage in sexual activity?”"|Month 3, Month12|All randomized participants who had evaluable data for Global Assessment Questions(GAQ)1 and GAQ2.||percentage of participants|||Number
858918|NCT02224846|Secondary|Percentage of Participants Achieving Normal Erectile Functioning of 5 mg Tadalafil Treatments||Month 18, Month 24||09/2018||||
858919|NCT02224846|Secondary|Percentage of Participants Achieving Normal Erectile Functioning of 5 mg Tadalafil Treatments|Participants achieving a normal erectile functioning (defined as having an IIEF-EF Domain score of >=26) at Month 6 and Month 12.|Month 6, Month 12|All enrolled subjects who fulfill the study entry criteria, receive at least one dose of tadalafil, and have both baseline and postbaseline data.||Percentage of participants|||Number
858921|NCT02224846|Secondary|"Percentage of Participants With Yes Responses to Sexual Encounter Profile (SEP) Diary"|Participant-assessed diary has 5 questions: 4 of the 5 questions were analyzed. Q2: successful penetration, Q3: successful intercourse, Q4: satisfied with erection, and Q5: satisfied with sexual experience) for each sexual encounter made over a specified period of time. SEP Q1-Q5 scores were determined as the percentage of 'Yes' responses to each of the 5 questions out of all sexual attempts recorded during the time period.|Month 1, Month 3|All enrolled subjects who fulfill the study entry criteria, receive at least one dose of tadalafil, and have both baseline and postbaseline data.||Percentage of participants||Standard Deviation|Mean
858922|NCT02224846|Secondary|Change From Baseline in the IIEF-EF Domain Questionnaire Score of 5 mg Tadalafil Treatments||Baseline, Month 18; Baseline, Month 24||09/2018||||
858923|NCT02224846|Secondary|Change From Baseline in the IIEF-EF Domain Questionnaire Score of 5 mg Tadalafil Treatments|IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Least Squares (LS) mean of the change from baseline is from Mixed effect Model Repeat Measurement (MMRM) model. The model included covariates baseline + visit + pooled investigator + baseline*visit, where participant is a random effect.|Baseline, Month 6; Baseline, Month 12|All enrolled participants who fulfill the study entry criteria, receive at least one dose of tadalafil, and have both baseline and postbaseline data.||units on a scale||Standard Error|Least Squares Mean
858924|NCT02224846|Secondary|Change From Baseline in the International Index of Erectile Function- Erectile Function (IIEF-EF) Domain Questionnaire Score|IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Least Squares (LS) mean of the change from baseline is from Mixed effect Model Repeat Measurement (MMRM) model.The model included covariates baseline + visit + pooled investigator + baseline*visit, where participant is a random effect.|Baseline, Month 1; Baseline, Month 3|All enrolled participants who fulfill the study entry criteria, receive at least one dose of tadalafil, and have both baseline and postbaseline data.||units on a scale||Standard Error|Least Squares Mean
858925|NCT02224846|Primary|Percentage of Participants Experiencing at Least One Treatment Emergent Adverse Event (Serious or Non-Serious)|A Treatment Emergent Adverse Event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline, regardless of causality or severity. The percentage of participants with TEAEs was calculated by dividing the number of participants with at least 1 TEAE over the 12-Month treatment period by the total number of participants analyzed, multiplied by 100%. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.|Baseline through Month 12|All enrolled participants who fulfill the study entry criteria and who receive at least one dose of tadalafil.||Percentage of participants|||Number
858926|NCT02211534|Secondary|Change in Pain Intensity - Average Pain Intensity|Pain Intensity (PI): a validated 11-point Numeric Pain Rating Scale (NPRS) with scores (0-10) collected as patient-reported outcomes on an electronic diary (ePRO).|At Days 75, 90, 150 and 240, as compared to Baseline|Data were not collected.|||||
858927|NCT02211534|Secondary|Change From Baseline in Peripheral Edema - Maximal Circumference of Calf (cm)|The maximal circumference of the calf and circumference of the thigh at 10 cm and 15 cm cranial to the superior pole of the patella of the index knee will be measured using a tape measure.|Day 75|Discrepancy in Numbers of Participants Analyzed is due to the number of subjects completing the Day 75 assessment. Not all subjects that were enrolled and had baseline data captured completed the Day 75 assessment. Subjects without a Day 75 assessment were left out of the analysis.||cm||Standard Deviation|Mean
858928|NCT02211534|Secondary|Change From Baseline in Range of Motion (ROM)|The degree of passive (movement of the knee with the aid of study personnel) and active (subject moving the knee) knee flexion and extension tolerated by the subject will be recorded. ROM will be assessed in the sitting position using a goniometer.|Days 0 (Baseline) and Day 75|||degrees of motion||Standard Deviation|Mean
858929|NCT02211534|Secondary|Analgesic Consumption|Consumption of opioid analgesics in the preceding 24 hours will be self-reported by the subject in the ePRO diary on a daily basis during the 10-day run-in period, treatment period and through Day 75. The results below display the difference in opioid analgesic consumption from baseline to Day 56-60. Subject recorded the number of tablets consumed.|Day 56 to Day 60 (compared to baseline)|Number of Participants Analyzed differs from numbers above due to the number of subjects reporting opioid analgesic consumption in their ePRO diary.||Number of tablets taken||Standard Deviation|Mean
858930|NCT02211534|Secondary|Patient Global Impression of Change (PGIC)|"Responder Analysis at Day 75 (patents stating they are Improved to Much Improved) using the Patient Global Impression of Change (PGIC). PGIC is a 7-point validated categorical scale of overall change in status since initiation of treatment with the study device. PGIC allows subjects to integrate into one overall evaluation the different aspects of their response to treatment, including pain reduction, improvement in functioning and side effects. Subjects select one of the following response at the end of treatment: Very Much Worse, Much Worse, Minimally Worse, No Change, Minimally Improved, Improved, or Much Improved."|Day 75|Discrepancy in Numbers of Participants Analyzed is due to the number of subjects completing the Day 75 assessment. Not all subjects that were enrolled and had baseline data captured completed the Day 75 assessment. Subjects without a Day 75 assessment were left out of the analysis.||Participants|||Count of Participants
858931|NCT02211534|Secondary|Beck Depression Inventory (BDI)|"Responders: Defined as subjects with a 5-point decrease in Beck Depression Inventory (BDI) score.
BDI is a validated self-reported assessment of current symptoms of depressive disorders, with total scores ranging from 0 to 63. The BDI scale consists of 21 groups of statements with each score/response ranging from 0 to 3. Higher scores represent greater depression. The BDI was conducted at baseline prior to study device treatments and again at Day 61."|Responders at Day 75 (compared to baseline)|Discrepancy in Numbers of Participants Analyzed is due to the number of subjects completing the Day 75 assessment. Not all subjects that were enrolled and had baseline data captured completed the Day 75 assessment. Subjects without a Day 75 assessment were left out of the analysis.||Participants|||Count of Participants
858932|NCT02211534|Secondary|Mean Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS)|Knee Injury and Osteoarthritis Outcome Score (KOOS): a validated knee-specific instrument that measures the short-term and long-term symptoms and function associated with knee injury. KOOS consists of 5 categories: pain, other symptoms, function in daily living, function in sport and recreation, and knee related quality of life. Patients are asked to answer questions relating to these categories and respond with Never/None/Not at all, Rarely/Monthly/Mild, Sometimes/Moderate/Weekly, Often/Severe/Daily or Always/Extreme/Totally/Constantly. Each response gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. The mean change in score from baseline to Day 75 is displayed below.|Mean change from Day 0 to Day 75|Discrepancy in Numbers of Participants Analyzed is due to the number of subjects completing the Day 75 assessment. Not all subjects that were enrolled and had baseline data captured completed the Day 75 assessment. Subjects without a Day 75 assessment were left out of the analysis.||units on a scale||Standard Deviation|Mean
858933|NCT02211534|Primary|Change in Pain Intensity|"Percent change from Baseline in Pain Intensity (PI): a validated 11-point Numeric Pain Rating Scale (NPRS) with scores (0-10) collected as patient-reported outcomes on an electronic diary (ePRO). A score of 0 represents 'No Pain' while a score of 10 represents Worst Pain Imaginable."|Assessed at Day 60 as compared to Baseline|Discrepancy in Numbers of Participants Analyzed is due to the number of subjects completing the Day 60 assessment. Not all subjects that were enrolled and had baseline data captured completed the Day 60 assessment. Subjects without a Day 60 assessment were left out of the analysis.||Units on a scale||Standard Deviation|Mean
858934|NCT02136004|Secondary|Procedure Success|Secondary efficacy endpoint - attainment of final arterial hemostasis using any method and freedom from major access site closure-related complications through 30 days|through 30 days +/- 7 days|All subjects enrolled.||Participants|||Count of Participants
858935|NCT02136004|Secondary|Rate of Combined Minor Access Site Closure-related Complications|Secondary safety endpoint - rate of combined minor access site closure-related complications|through 30 +/- 7 days|All subjects enrolled||complications|||Number
858936|NCT02136004|Secondary|Device Success|Secondary efficacy endpoint - the ability to deploy the system, deliver the implant, and achieve arterial hemostasis with the Closer VSS alone or with post-hemostasis adjunctive compression|procedural, usually within 15 minutes of enrollment|All subjects enrolled||Participants|||Count of Participants
858937|NCT02136004|Secondary|Time to Hospital Discharge|Secondary efficacy endpoint - elapsed time between Closer VSS delivery system removal and when subject is actually physically discharged from the hospital ward|through hospital discharge, usually within 24 hours|All subjects enrolled||hours||95% Confidence Interval|Mean
858938|NCT02136004|Secondary|Time to Discharge Eligibility|Secondary efficacy endpoint - elapsed time between Closer VSS delivery system removal and when subject's access site is assessed to be hemodynamically stable, as determined by the investigator or his/her designee(s)|prior to hospital discharge, usually within 24 hours|All subjects enrolled||hours||95% Confidence Interval|Mean
858939|NCT02136004|Secondary|Time to Ambulation|Secondary efficacy endpoint - elapsed time between the Closer VSS delivery system removal and when subject stands and walks 20 feet without evidence of arterial re-bleeding from the access site|prior to hospital discharge, usually within 24 hours|All subjects enrolled||hours||95% Confidence Interval|Mean
858940|NCT02136004|Primary|Rate of Combined Major Access Site Closure-related Complications|Primary safety endpoint - rate of combined major access site closure-related complications|Through 30 days +/- 7 days|All subjects enrolled||complications|||Number
858941|NCT02136004|Primary|Time to Hemostasis|Primary effectiveness endpoint - elapsed time between the Closer VSS delivery system removal and first observed and confirmed arterial hemostasis|procedural, usually within 15 minutes of enrollment|All subjects enrolled||minutes||95% Confidence Interval|Mean
858942|NCT02108951|Secondary|Mean M.D. Anderson Symptom Inventory - Chronic Myeloid Leukemia (MDASI-CML)|"Quality of life was assessed using the M.D. Anderson Symptom Inventory - Chronic Myeloid Leukemia (MDASI-CML) self-administered questionnaire for adult CML patients. The questionnaire consisted of 13 core questions in part I measuring the severity of symptoms, 6 questions in part 2 assessing the interference of symptoms on daily living. The CML component of the MDASI provided an additional 7 CML-specific symptom items: diarrhea, swelling, rash/skin change, muscle soreness/cramping, bruising/bleeding easily, malaise, and headache. In part I (13 questions) and the CML component (7 questions) each question was scored from 0 to 10 where 0 indicates a symptom is not present and 10 indicate the symptom is as bad as you can imagine. For part 1 the total score can therefore range from 0 to 130 and for CML 0 to 70. Part 2 is also recorded on a 0 to 10 scale, but 0 now indicates that the symptom “did not interfere” and 10 “interfered completely”. The total score can range from 0 to 60."|Baseline, week 12, 24, 48, 96|The full analysis set (FAS) consists of all patients enrolled into the study. 'n' in the categories represents the number of patients with evaluable data for MDASI part 1/MDASI part 2/CML component at different time points. Week 96 includes end of study results for patients that did not complete the study.||units on a scale||Standard Deviation|Mean
858943|NCT02108951|Secondary|Number of Patients With Events Reported at Baseline That Have Shown an Improvement in Non-hematological AE Severity Compared to Week 12 Visit|The total number of patients that have showed improvement with respect to CTCAE grades at the time of the 12-week visit are reported. Improved is defined as prior to, or at the time of the 12-week visit, the AE has completely resolved.|Baseline, week 12 (month 3)|The Safety Set (SS) consisted of all patients in the FAS who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.||Participants|||Count of Participants
858944|NCT02108951|Secondary|Time to Event Free Survival (EFS)|"EFS was defined as the time from date of baseline visit to the first occurrence of any of the following: Disease progression, treatment failure or death from any cause, whichever was earlier. Patients who did not have an event of interest were censored at earliest of the following:
the date of the 24-month visit;
the date of loss to follow-up;
the date of withdrawal from the study for any reason other than lack of efficacy/progressive disease, tolerance to reduced dose or death"|96 weeks (24 months)|There were no patients in the study who were recorded as experiencing treatment failure.|||||
858970|NCT01911169|Secondary|Change in Interferon Signature|This outcome was not measured as planned|from zero to sixteen weeks||||||
858945|NCT02108951|Secondary|Time to Progression-free Survival (PFS)|"PFS was defined as the time from the date of baseline visit to the date of earliest progression-defining event: namely progression (or withdrawal due to progression to blast crisis (BC) or accelerated phase (AP) disease), or death from any cause.
Patients who did not progress were censored at earliest of the following:
the date of the 24-month visit;
the date of loss to follow-up;
the date of discontinuation of study treatment for any reason other than progression to BC, or AP disease, or death"|96 weeks (24 months)|The FAS consists of all patients enrolled into the study. There were no withdrawals due to progression to BC or AP disease, and there were no recorded deaths during the study.|||||
858946|NCT02108951|Secondary|Kaplan-Meier Estimates of Time to Deep Molecular Response (MR4.5)|"Breakpoint cluster region - Abelson murine leukemia (BCR-ABL) levels is measured in patients by real-time quantitative polymerase chain reaction (RQ-PCR) testing of peripheral blood by the 24 months following the commencement of nilotinib therapy. MR4.5 corresponds to a
BCR-ABL ratio 0.0032% IS using RQ-PCR. The derivation of time to molecular response for patients in the study was measured from the date of first nilotinib use, defined as follows:
Days to MR4.5 = date of assessment where BCR-ABL ratio is 0.0032% IS - date of baseline + 1."|96 weeks (24 months)|The full analysis set (FAS) consists of all patients enrolled into the study. N represents all patients in FAS who achieved MR4.5.||days||95% Confidence Interval|Median
858947|NCT02108951|Secondary|Kinetics of Molecular Response: Percentage of Patients With MR4.5 Based on BCR-ABL Over Time After the Switch to Nilotinib|MR4.5 corresponds to a BCR-ABL ratio 0.0032% international scale (IS) using Real-time quantitative polymerase chain reaction (RQ-PCR).|Baseline, week 4, 8, 12, 24, 36, 48, 60, 72, 84, 96|Full analysis set. n = number of patients with evaluable data at the defined time point||percentage of patients|||Number
858948|NCT02108951|Secondary|Kinetics of Molecular Response: Percentage of Patients With MR4.0 Based on BCR-ABL Over Time After the Switch to Nilotinib|MR4.0 corresponds to a BCR-ABL ratio 0.01% international scale (IS) using Real-time quantitative polymerase chain reaction (RQ-PCR).|Baseline, week 4, 8, 12, 24, 36, 48, 60, 72, 84, 96|Full analysis set||percentage of patients|||Number
858949|NCT02108951|Secondary|Kinetics of Molecular Response: Percentage of Patients With MMR Based on BCR-ABL Over Time After the Switch to Nilotinib|MMR corresponds to a BCR-ABL ratio 0.1% international scale (IS) using Real-time quantitative polymerase chain reaction (RQ-PCR).|Baseline, week 4, 8, 12, 24, 36, 48, 60, 72 and 96|Full analysis set. n = number of patients with evaluable data at the defined time point||percentage of patients|||Number
858950|NCT02108951|Secondary|Kinetics of Molecular Response: Percentage of Patients With no Response Based on BCR-ABL Over Time After the Switch to Nilotinib|No response corresponds to a BCR-ABL ratio < 0.1% international scale (IS) using Real-time quantitative polymerase chain reaction (RQ-PCR).|Baseline, week 4, 8, 12, 24, 36, 48, 60, 72, 84, 96|Full analysis set. n = number of patients with evaluable data at the defined time point||percentage of patients|||Number
858951|NCT02108951|Primary|Number of Patients With MR4.5 Response by Baseline BCR-ABL Response Level Within 24 Months|"Deep Molecular Response (MR4.5) rate is defined as the percentage of patients who have achieved a 4.5 -log reduction in Breakpoint cluster region - Abelson murine leukemia (BCR-ABL) levels. BCR-ABL levels are measured in patients by real-time quantitative polymerase chain reaction (RQ-PCR) testing of peripheral blood by the 24 months following the commencement of nilotinib therapy.
MR4.5 corresponds to a BCR-ABL ratio 0.0032% international scale (IS) using RQ-PCR. If a post-baseline value for BCR-ABL is < 0.1 X the baseline value, the patient were classified as achieving a 1 log reduction in BCR-ABL."|Baseline, 96 weeks (24 months)|The full analysis set (FAS) consists of all patients enrolled into the study. 'n' in categories indicates patients achieved or did not achieve MR4.5 during 24 months||Participants|||Count of Participants
858952|NCT02108951|Primary|Duration of Prior TKI Therapy for Patients Based on MR4.5 Achievement Status Within 24 Months|"Breakpoint cluster region - Abelson murine leukemia (BCR-ABL) levels are measured in patients by real-time quantitative polymerase chain reaction (RQ-PCR) testing of peripheral blood by the 24 months following the commencement of nilotinib therapy.
Deep molecular response (MR4.5) rate was defined as the percentage of patients who have achieved a 4.5-log reduction (MR4.5) in BCR-ABL levels during the 24 months following the commencement of nilotinib therapy. MR4.5 corresponds to a BCR-ABL ratio 0.0032% IS using RQ-PCR. If a post-baseline value for BCR-ABL is < 0.1 X the baseline value, the patient were classified as achieving a 1 log reduction in BCR-ABL."|Baseline, 96 weeks (24 months)|The full analysis set (FAS) consists of all patients enrolled into the study.||months||Standard Deviation|Mean
858953|NCT02108951|Primary|Major Molecular Response (MMR) Rate: Percentage of Patients Who Have Achieved a 3 Log Reduction in BCR-ABL Levels Within 12 Months and 24 Months|Major Molecular Response (MMR) rate is defined as the percentage of patients who have achieved a 3 log reduction in BCR-ABL levels at 12 months and at 24 months following the commencement of nilotinib therapy. Breakpoint cluster region - Abelson murine leukemia (BCR-ABL) levels are measured in patients by real-time quantitative polymerase chain reaction (RQ-PCR) testing of peripheral blood at the 12 and 24 months following the commencement of nilotinib therapy. MMR corresponds to a BCR-ABL ratio 0.1% international scale (IS) using RQ-PCR. If a post-baseline value for BCR-ABL is < 0.1 * the baseline Value, the patient will be classified as achieving a 1 log drop.|Baseline, 48 weeks (12 months), 96 weeks (24 months)|The full analysis set (FAS) consists of all patients enrolled into the study.Analysis of MMR was undertaken on the subgroup of the FAS that was not at MMR at baseline.||Percentage of participants||95% Confidence Interval|Number
858954|NCT02108951|Primary|Molecular Response (MR4.0) Rate: Percentage of Patients Who Have Achieved a 4.0-log Reduction in BCR-ABL Level Within 12 Months and 24 Months|"Molecular Response (MR4.0) rate is defined as the percentage of patients who have achieved a 4-log reduction in BCR-ABL levels at 12 months and 24 months following the commencement of nilotinib therapy. Breakpoint cluster region - Abelson murine leukemia (BCR-ABL) levels are measured in patients by real-time quantitative polymerase chain reaction (RQ-PCR) testing of peripheral blood by the 24 months following the commencement of nilotinib therapy.
MR4.0 corresponds to a BCR-ABL ratio 0.01% international scale (IS) using RQ-PCR. If a post-baseline value for BCR-ABL is < 0.1 X the baseline value, the patients were classified as achieving a 1 log reduction in BCR-ABL."|Baseline, 48 weeks (12 months), 96 weeks (24 months)|The full analysis set (FAS) consists of all patients enrolled into the study. Analysis of MR4.0 was undertaken on the subgroup of the FAS that was not at MR4.0 at baseline.||Percentage of participants||95% Confidence Interval|Number
858955|NCT02108951|Primary|Deep Molecular Response (MR4.5) Rate: Percentage of Patients Who Have Achieved a 4.5-log Reduction in BCR-ABL Level Within 24 Month|"Deep Molecular Response (MR4.5) rate is defined as the percentage of patients who have achieved a 4.5 -log reduction in Breakpoint cluster region - Abelson murine leukemia (BCR-ABL) levels. BCR-ABL levels are measured in patients by real-time quantitative polymerase chain reaction (RQ-PCR) testing of peripheral blood by the 24 months following the commencement of nilotinib therapy.
MR4.5 corresponds to a BCR-ABL ratio 0.0032% international scale (IS) using RQ-PCR. If a post-baseline value for BCR-ABL is < 0.1 X the baseline value, the patient were classified as achieving a 1 log reduction in BCR-ABL."|Baseline, 96 weeks (24 months)|The full analysis set (FAS) consists of all patients enrolled into the study.||Percentage of participants||95% Confidence Interval|Number
858956|NCT02057952|Secondary|Diastolic Blood Pressure|Diastolic blood pressure. Measured using blood pressure cuff and sphygmomanometer. Units in Milometers of Mercury (mmHg). Scale range is based on participants' actual blood pressure (change baseline to 12 months; positive value indicates decrease in blood pressure).|12 Months|Participants who completed 12 month follow-up||mmHg||Standard Deviation|Mean
858957|NCT02057952|Secondary|Change in Baseline Blood Pressure at 12 Months||12 Months||||||
858958|NCT02057952|Secondary|Change in Baseline Blood Pressure at 6 Months||12 Months||||||
858959|NCT02057952|Secondary|Change From 6 Month SF 36 at 12 Months|The Short Form 36 survey or SF 36 is a patient report survey where the lower the score the more disability the patient reports having.|12 Months||||||
858960|NCT02057952|Secondary|Change From Baseline SF 36 at 6 Months|The Short Form 36 survey or SF 36 is a patient report survey where the lower the score the more disability the patient reports having.|12 Months||||||
858961|NCT02057952|Secondary|Cost-effectiveness|Cost effectiveness is a survey that measures how much money in US Dollars the participant has had to spend to take part in the program.|12 months||||||
858962|NCT02057952|Secondary|Systolic Blood Pressure|Systolic blood pressure. Measured using blood pressure cuff and sphygmomanometer. Units in Milometers of Mercury (mmHg). Scale range is based on participants' actual blood pressure (change baseline to 12 months). Positive value indicates decrease in blood pressure).|12 Months|Participants who completed 12 month follow-up||mmHg||Standard Deviation|Mean
858963|NCT02057952|Secondary|Short Form 36 Survey|The Short Form 36 survey or Short-Form 36 is a patient report survey. Scores range from 0 (worst) to 100 (best) and represent overall health-related quality of life.|Baseline to 12 Months|The analysis of change based on participants with complete Short Form 36 (SF36) scores at baseline and 12 months.||score on scale||Standard Deviation|Mean
858964|NCT02057952|Primary|Change in Body Weight From Baseline to 6 Months.|Pounds lost from baseline to 6 months.|12 months|Analysis are based on number of participants with complete weight data at baseline and 6 months.||pounds||Standard Deviation|Mean
858965|NCT02057952|Primary|Attendance Reported in Minutes|Minutes of participation in study sessions.|12 Months|Usual care participants didn't have access to the experimental treatments. In person and video conference arm participants were all eligible for participation.||minutes||Full Range|Median
858966|NCT02057952|Primary|Body Weight|Change in weight from baseline to 12 months reported in pounds.|Baseline to 12 Months|The number of participants analyzed is based on the number of participants who completed weight data at baseline and 12 months.||pounds||Standard Deviation|Mean
858967|NCT01943435|Other Pre-specified|Sense Wear Armband|Our secondary aim was to measure the change in physical activity between baseline and 8 weeks using the Sense Wear armband (SWA). The outcome measure was the average number of minutes spent daily performing physical activities >1.5 metabolic equivalents (METs).The SWA is a small device that collects information from multiple sensors: a triaxial accelerometer, heat flux, skin temperature, and galvanic signal. The information is integrated and processed by software using proprietary algorithms utilizing subjects' demographic characteristics (gender, age, height, and weight) to provide minute-by-minute estimates of physical activity. The SWA has shown good reliability and validity. The research participants in our study will wear the SWA for a week before and after they complete the treatment interventions.|Primary End-Point was analysis of between-group changes at 8 weeks ( 2 weeks after completion of 6-week intervention).|Intent to treat population. Analysis performed on all participants who attended at least one intervention session and had a follow-up examination at 8 weeks. Linear mixed models were used to account for missing data, which did not change the results of our multivariable linear regression models.||minutes per day||Standard Deviation|Mean
858968|NCT01943435|Secondary|Self Paced Walking Test (SPWT)|Our primary aim also included a performance-based outcome measure, which was the distance walked during the SPWT. The analysis was a comparison of between-group changes in SPWT between baseline and 8 weeks. The Self-Paced Walking Test (SPWT) is a validated objective measure of a patient's walking capacity, which is performed on a level walking surface. The patient is instructed to walk at their own pace and to stop when the symptoms are troublesome enough that s/he needs to sit down to rest. The total time and total distance walked are measured by the research assistant. Our unit of measure was the total distance walked, expressed in meters.|Primary end-point was analysis of between-group changes at 8 weeks ( 2 weeks after 6 week intervention is completed).|Intent to treat population. Analysis performed on all participants who attended at least one intervention session and had a follow-up examination at 8 weeks. Linear mixed models were used to account for missing data, which did not change the results of our multivariable linear regression models.||meters||Standard Deviation|Mean
858969|NCT01943435|Primary|Swiss Spinal Stenosis (SSS) Questionnaire Score (Symptom Severity Subscore)|Our primary aim included a primary outcome measure of self-reported pain/function, which was the change in SSS symptom severity subscore between baseline and 8 weeks. The Swiss Spinal Stenosis Questionnaire (SSS) is a validated 12-item condition-specific instrument for patients with lumbar spinal stenosis. It provides a patient self-report measure of pain and physical function. Higher scores represent worse symptoms and less physical function. The 12-item SSS consists of two subscores: 1) the 7-item symptom severity subscore (range 7-35) and 2) the 5-item physical function subscore (range 5-20). For our analysis, we compared the change in the 7-item symptom severity subscore from baseline to 8 weeks.|Primary End-Point was analysis of between-group changes at 8 weeks ( 2 weeks after completion of 6-week intervention).|Intent to treat population. Analysis performed on all participants who attended at least one intervention session and had a follow-up examination at 8 weeks. Linear mixed models were used to account for missing data, which did not change the results of our multivariable linear regression models.||scores on a scale||Standard Deviation|Mean
858971|NCT01911169|Primary|Change at Week 16 in % Flow Mediated Dilation in Those Who Did and Did Not Replete Vitamin D|Measures were be performed with a Phillips iU22 Ultrasound system and a L9-3 9 mHz probe in 2D mode by a single operator using EKG gating. Baseline measures of brachial artery diameter will be made after the 10 minutes of rest. The blood pressure cuff, placed on the ipsilateral forearm, was inflated to 50 mmHg above the patient's systolic blood pressure for five minutes and then released. Endothelium-dependent FMD was measured continuously during and for three minutes after cuff release. Subjects rested for 10 minutes. Then, endothelium-independent dilation was measured 3 minutes after administration of 0.4 mg of sublingual nitroglycerine. The outcome (%FMD) was the difference between the average endothelium dependent diameter after cuff deflation and the average baseline diameter. The absolute difference between the % FMD at baseline and 16 week follow up was reported.|from zero to sixteen weeks|||Absolute change in % FMD||Standard Deviation|Mean
858972|NCT01905683|Secondary|Changes in Gross Motor Function Measure (GMFM)-66 Score From Baseline to All Injection Visits and End of Study|The GMFM-66 is a standardized observational 66-item instrument designed and validated to measure change in gross motor function over time in participants with cerebral palsy. Score values represent the total GMFM-66 score. Total GMFM scores range from 0 (worst) to 100 (best).|Baseline to Day 1 of 2nd (V5), 3rd (V7), 4th (V9) IC and End of study (Week 44-68) (V11)|The FAS was the subset of participants in the SES for whom at least a baseline value (Day 1 of the first cycle, Visit 2) of AS score of PF was available. For participants from lead-in study at least one post-baseline value was available. Therefore all participants from lead-in study were included in FAS.||units on a scale||Standard Deviation|Mean
858973|NCT01905683|Secondary|Change in Scores of Pain Intensity (From Participants) and Frequency (From Parent/Caregiver) From Baseline to All Visits, From Day 1 of Each IC to Day 29 (Week 4), Day 57 (Week 8, 1st IC Cycle Only) and Day 99 (Week 14) of Respective Injection|The questionnaire on pain caused by Spasticity (QPS) is a participant-reported outcome for children and adolescents (2-17 years) with cerebral palsy on spasticity-related pain. Pain intensity (from participants) and pain frequency (from parent/caregiver) to be assessed with QPS. The QPS total score for pain intensity ranges from 0 (’No Hurt’) to 10 (’Hurt Worst’). The QPS total score for the observed pain frequency ranges from 0 (Never) to 4 (Always). V3 = Week 4 of 1st IC; V4 = Week 8 of 1st IC; V5= Day 1 of 2nd IC; V6 = Week 4 of 2nd IC; V7 = Day 1 of 3rd IC; V8 = Week 4 of 3rd IC; V9 = Day 1 of 4th IC; V10 = Week 4 of 4th IC; V11 = Week 14 of 4th IC = end of study visit.|Baseline (Day 1, Visit [V] 2) to all other visits (V3, V4, V5, V6, V7, V8, V9, V10, and V11); From Day 1 of Each IC to Day 29 (Week 4), Day 57 (Week 8, 1st IC cycle only) and Day 99 (Week 14) of the respective IC|The FAS was the subset of participants in the SES for whom at least a baseline value (Day 1 of the first cycle, Visit 2) of AS score of PF was available. For participants from lead-in study at least one post-baseline value was available.||units on a scale||Standard Deviation|Mean
858974|NCT01905683|Secondary|Changes in Modified Tardieu Scale (MTS) of Left and Right PF From Baseline to All Other Visits, From Day 1 of Each Injection Cycle (IC) to Day 29 (Week 4), Day 57 (Week 8, 1st IC Only) and Day 99 (Week 14) of the Respective Injection Cycle|"The MTS assesses spastic muscle tone by subtraction of two angles measured at different conditions of passive muscle stretch. R2 is the angle of passive range of motion with a passive movement at slow speed. R1 is the angle where a catch-and-release or clonus can be triggered at the fastest possible speed. Score values represent the measured (R2-R1) difference, that is, the dynamic tone component of the examined muscle(s). Decreases of (R2-R1) represent reductions in the dynamic component of spasticity, that is, improvement of dynamic muscle spasticity. V3 = Week 4 of 1st IC; V4 = Week 8 of 1st IC; V5 = Day 1 of 2nd IC; V6 = Week 4 of 2nd IC; V7 = Day 1 of 3rd IC; V8 = Week 4 of 3rd IC; V9 = Day 1 of 4th IC; V10 = Week 4 of 4th IC; V11 = Week 14 of 4th IC = end of study visit."|Baseline (Day 1, Visit [V] 2) to all other visits (V3, V4, V5, V6, V7, V8, V9, V10, and V11); From Day 1 of Each IC to Day 29 (Week 4), Day 57 (Week 8, 1st IC cycle only) and Day 99 (Week 14) of the respective IC|The FAS was the subset of participants in the SES for whom at least a baseline value (Day 1 of the first cycle, Visit 2) of AS score of PF was available. For participants from lead-in study at least one post-baseline value was available.||Degrees||Standard Deviation|Mean
858975|NCT01905683|Secondary|Investigator's Global Impression of Change of Plantar Flexor Spasticity Scale (GICS-PF) of Left and Right PF at Day 29 (Week 4) of Each Injection Cycle|The GICS are global outcomes to assess the impression of change due to treatment. GICS were assessed by the investigator, by the participant (if feasible) and by parents'/caregiver (if applicable). GICS is a 7-Point Likert Scale ranging from +3 (very much improved function) to -3 (very much worse function). For participants with bilateral pes equinus, the body side for efficacy analysis that is “primary body side” was decided by investigator at screening and was kept throughout the entire study.|Day 29 (Week 4) of 1st, 2nd, 3rd and 4th injection cycle|The FAS was the subset of participants in the SES for whom at least a baseline value (Day 1 of the first cycle, Visit 2) of AS score of PF was available. For participants from lead-in study at least one post-baseline value was available.||units on a scale||Standard Deviation|Mean
858976|NCT01905683|Secondary|Investigator's, Child's/Adolescent's, and Parent's/Caregiver's Global Impression of Change Scale (GICS) at Day 29 (Week 4) of Each Injection Cycle|The GICS are global outcomes to assess the impression of change due to treatment. GICS were assessed by the investigator, by the participant (if feasible) and by parents'/caregiver (if applicable). GICS is 7-Point Likert Scale ranging from +3 (very much improved function) to -3 (very much worse function).|Day 29 (Week 4) of 1st, 2nd, 3rd and 4th injection cycle|The FAS was the subset of participants in the SES for whom at least a baseline value (Day 1 of the first cycle, Visit 2) of AS score of PF was available. For participants from lead-in study at least one post-baseline value was available.||units on a scale||Standard Deviation|Mean
858987|NCT01695239|Secondary|Change From Baseline in the Nail Psoriasis Severity Index (NAPSI) Score Fingernail Involvement at Baseline|The NAPSI scale is used to evaluate the severity of fingernail bed Ps and fingernail matrix Ps by area of involvement. The fingernail is divided into quadrants. Each fingernail is given a score for fingernail bed Ps 0 (none) to 4 (Ps in 4 quadrants of the fingernail) and fingernail matrix Ps 0 (none) to 4 (Ps in 4 quadrants of the matrix), depending on the presence (score of 1) or absence (score of 0) of any of the features of fingernail bed or matrix Ps in each quadrant. The sum of all fingernails equals the total NAPSI score range is from 0 (no effect) to 80 (more severe psoriasis). LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.|Baseline, Week 24|All randomized participants who had baseline fingernail involvement, baseline NAPSI score and post baseline NAPSI score.||units on a scale||Standard Error|Least Squares Mean
858977|NCT01905683|Secondary|Changes in AS Score of Left and Right Plantar Flexors (PF) From Baseline to All Other Visits, From Day 1 of Each Injection Cycle to Day 29 (Week 4), Day 57 (Week 8, 1st Injection Cycle Only) and Day 99 (Week 14) of the Respective Injection Cycle|The Ashworth Scale (AS) is a well-known and commonly used scale in clinical trials with spasticity. In spastic muscles the resistance to passive movement is assessed. It is a 5-point scale that ranges from 0 (= no increase in tone) to 4 (=limb rigid in flexion or extension). For participants with bilateral pes equinus, the body side for efficacy analysis that is, “primary body side” was decided by investigator at screening and was kept throughout the entire study. V3 = Week 4 of 1st Injection Cycle; V4 = Week 8 of 1st Injection Cycle; V5 = Day 1 of 2nd Injection Cycle; V6= Week 4 of 2nd Injection Cycle; V7 = Day 1 of 3rd Injection Cycle; V8 = Week 4 of 3rd Injection Cycle; V9 = Day 1 of 4th Injection Cycle; V10 = Week 4 of 4th Injection Cycle; V11= Week 14th of 4th Injection Cycle = end of study visit.|Baseline (Day 1, Visit [V] 2) to all other visits (V3, V4, V5, V6, V7, V8, V9, V10, and V11); From Day 1 of Each Injection Cycle to Day 29 (Week 4), Day 57 (Week 8, 1st Injection Cycle only) and Day 99 (Week 14) of the respective Injection Cycle|The full analysis set (FAS) was the subset of participants in the SES for whom at least a baseline value (Day 1 of the first cycle, Visit 2) of AS score of PF was available. For participants from lead-in study at least one post-baseline value was available.||units on a scale||Standard Deviation|Mean
858978|NCT01905683|Secondary|Investigator’s Global Assessment of Tolerability at Day 99 (Week 14) of Each Injection Cycle|The investigator’s global assessment of tolerability was assessed on a 4-point ordinal scale where 1 = very good, 2 = good, 3 = moderate, and 4 = poor. Results for Day 99 (Week 14) of 4th injection cycles were collected at the end of study visit.|Day 99 (Week 14) of 1st, 2nd, 3rd and 4th injection cycle|The SES was the subset of all participants treated with IP at least once.||participants|||Number
858979|NCT01905683|Primary|Occurrence of Treatment-emergent Serious Adverse Events (TESAEs) Overall and Per Injection Cycle|TESAEs are events observed from the time point of first injection until end of study visit (Week 50-66). Values reported here refer to the number of participants affected.|From the timepoint of first injection until end of study visit (Week 50-66)|The SES was the subset of all participants treated with IP at least once.||participants|||Number
858980|NCT01905683|Primary|Occurrence of Treatment Emergent Adverse Events of Special Interest (TEAESI) Overall and Per Injection Cycle|TEAEs occurring after treatment that were thought to possibly indicate toxin spread throughout the trial conduct are defined as TEAESI. Values reported here refer to the number of participants affected.|From the timepoint of first injection until end of study visit (Week 50-66)|The SES was the subset of all participants treated with IP at least once.||participants|||Number
858981|NCT01905683|Primary|Occurrence of Treatment Emergent Adverse Events (TEAEs) Overall and Per Injection Cycle|TEAEs are events observed from the time point of first injection until end of study visit (Week 50-66). Values reported here refer to the number of participants affected.|From the timepoint of first injection up to end of study visit (Week 50-66)|The SES was the subset of all participants treated with IP at least once.||participants|||Number
858982|NCT01867710|Secondary|Percentage of Participants With Confirmed Prostate Specific Antigen (PSA) Response Rate [Greater Than or Equal to (>=) 50 Percent (%) Decline From Baseline] at Week 12|The PSA response is defined as a >= 50% decline from baseline according to the adapted Prostate Cancer Working Group 2 (PCWG2) criteria. For a PSA response to be confirmed, an additional PSA measurement obtained 4 or more weeks later has to show >=50% decline from baseline.|Week 12|Intent-to-treat (ITT) population included all randomized participants regardless of whether they received any study treatment. Here “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.||Percentage of Participants||95% Confidence Interval|Number
858983|NCT01867710|Primary|Percentage of Participants Experiencing Neither of the 2 Mineralocorticoid Excess Toxicity During the First 24 Weeks of Treatment|No mineralocorticoid excess is defined as experiencing neither of the 2 mineralocorticoid excess toxicities, that is, neither hypokalemia nor hypertension.|Week 24|Safety population included all randomized and treated participants. Here “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.||Percentage of Participants||95% Confidence Interval|Number
858984|NCT01695239|Secondary|Number of Participants With Treatment Emergent Anti-Ixekizumab Antibodies (TE-ADA) and Neutralizing Antibodies (NAb)|Number of participants with positive treatment emergent anti-ixekizumab antibodies and NAb was summarized by treatment group.|Baseline to Week 24|All randomized participants who received at least 1 dose of ixe and had evaluable anti-ixekizumab antibody measurement at baseline and postbaseline or had no evaluable baseline anti-ixekizumab antibody measurements. Immunogenicity data was not collected during the double-blind treatment period for participants in the adalimumab treatment group.||participants|||Number
858985|NCT01695239|Secondary|Change From Baseline in in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)|The BASDAI is a self-administered measure used to answer 6 questions with a 0 to 10 centimeter (cm) VAS pertaining to the 5 major symptoms of axial activity. To give each symptom equal weighting, the mean of the 2 scores relating to morning stiffness was taken. The resulting 0 to 50 score was divided by 5 to give a final 0 to 10 BASDAI Score. BASDAI ranges from 0-10. Higher scores represent greater disease activity. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.|Baseline, Week 24|All randomized participants who had baseline axial involvement defined as baseline BASDAI score >4, baseline BASDAI score and post baseline BASDAI score.||units on a scale||Standard Error|Least Squares Mean
858986|NCT01695239|Secondary|Change From Baseline in Leeds Dactylitis Index-Basic (LDI-B)|The LDI-B measures the severity of dactylitis. In each digit, the ratio of the circumference of the affected digit to the circumference of the digit on the opposite hand or foot measured in mm. Each dactylitic digit was defined by a minimum increase of 10% in circumference over the contra-lateral digit. If the same digits on each hand or foot were thought to be involved, the clinician referred to a table of normative values for a value which was used to provide the comparison. The calculated ratio was multiplied by a tenderness score of 0 (not tender) or 1 (tender). Tenderness was assessed in the area between the joints. The results of each digit were then added to produce a total score. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.|Baseline, Week 24|All randomized participants who had baseline dactylitis, baseline LDI-B score and post baseline LDI-B score.||units on a scale||Standard Error|Least Squares Mean
858988|NCT01695239|Secondary|Percent Change From Baseline in Body Surface Area (BSA)|The investigator evaluated the percentage involvement of psoriasis on each participant's BSA on a continuous scale from 0% = no involvement to 100% = full involvement, where 1% corresponded to the size of the participant’s handprint including the palm, fingers, and thumb. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.|Baseline, Week 24|All randomized participants who have plaque psoriasis at baseline and who had baseline and post baseline BSA data.||percent change in BSA||Standard Error|Least Squares Mean
858989|NCT01695239|Secondary|Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of 0 or 1 and With at Least a 2-point Improvement From Baseline|The sPGA is the physician’s determination of the severity of the participant’s psoriasis lesions overall at a given time point. Overall lesions were categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant’s psoriasis was assessed at a given time point on in which 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe.|Week 24|All randomized participants who have plaque psoriasis and sPGA ≥3 at baseline. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.||percentage of participants|||Number
858990|NCT01695239|Secondary|Percentage of Participants Meeting the Psoriatic Arthritis Response Criteria (PsARC Modified)|The PsARC is a composite criteria reported in terms of the percentage of participants achieving response according to the following criterion: TJC, SJC, PGA, and PatGA. Overall response is defined by improvement from baseline assessment in 2 of 4 criteria, 1 of which must be a joint count; there must not be worsening in any of the 4 criteria: at least 30% reduction in TJC, at least 30% reduction in SJC, at least a 20 millimeter (mm) reduction in PGA and at least a 20 mm reduction in PatGA which is equivalent to 20 mm reduction. The results from the 2 VAS measures were assessed as a difference from baseline in mm.|Week 24|All randomized participants. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.||percentage of participants|||Number
858991|NCT01695239|Secondary|Change From Baseline in Disease Activity Score (28 Diarthrodial Joint Count) Based on C-ReactiveProtein (DAS28-CRP) Measure: Non-Arthritic Disease|The DAS28-CRP is a measure of disease activity in 28 joints that consists of a composite numerical score with the following variables: TJC28, SJC28, hs-CRP (measured in mg/L), and Participant’s Global Assessment of Disease Activity recorded by participants on a 0 to 100 millimeter (mm) VAS. For DAS28-CRP, the Tender Joint Count 28 (TJC28) and Swollen Joint Count (SJC28) are a subset of TJC and SJC, and include 14 joints on each side of the body: 2 shoulders, 2 elbows, 2 wrists, 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. DAS28 values range from 0 to 9.4. Higher values indicate more severe symptoms and greater functional impairment. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit.|Baseline, Week 24|All randomized participants who had baseline and post baseline DAS28-CRP data.||units on a scale||Standard Error|Least Squares Mean
858992|NCT01695239|Secondary|Change From Baseline in Quick Inventory of Depressive Symptomatology-Self Reported 16 Items (QIDS-SR16) (Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes [PRO])|The QIDS-SR16 is a self-administered 16-item instrument intended to assess the existence and severity of symptoms of depression. A participant is asked to consider each statement as it relates to the way they have felt for the past 7 days. Each item scaled from 0 (no symptoms) to 3 (all symptoms). The 16 items corresponding to 9 depression domains are summed to give a single score ranging from 0 to 27, with higher scores denoting greater symptom severity. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.|Baseline, Week 24|All randomized participants who had baseline and post baseline QIDS-SR16 data.||units on a scale||Standard Error|Least Squares Mean
858993|NCT01695239|Secondary|Change From Baseline in Medical Outcomes Study 36-item Short Form Health Survey (SF-36): Physical Component Summary (PCS) and Mental Component Summary (MCS) (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO])|SF-36 is a standardized participant-administered measure designed to evaluate 8 domains of functional health and well being: physical and social functioning, physical and emotional role (role-physical, role-emotional) limitations, bodily pain, general health, vitality, mental health with 2 components (physical component score [PCS] and mental component score [MCS]). The PCS and MCS scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.|Baseline, Week 24|All randomized participants who had baseline and post baseline PCS data. All randomized participants who had baseline and post baseline MCS data.||units on a scale||Standard Error|Least Squares Mean
858994|NCT01695239|Secondary|Change From Baseline in Joint Space Narrowing Score (JSN) And Bone Erosion Score (BES)|JSN score (a component of the modified Total Sharp Score [mTSS]) measures the extent of joint space narrowing in peripheral joints. JSN (20 joints per hand and 6 joints per foot), with higher scores representing greater damage. JSN score range is 0 (no narrowing) to 208 (high narrowing). Increase from baseline represents disease progression and / or joint worsening. BES (a component of the [mTSS]) measures the extent of bone erosion in peripheral joints. BES measures the extent of joint erosions (20 joints per hand and 12 joints per foot), with higher scores representing greater damage. Erosion score range is from 0 (no erosion) to 320 (high erosion). LS mean was calculated using linear extrapolation for ANCOVA analysis with treatment, baseline score, geographic region, and baseline cDMARD experience.|Baseline, Week 24|All randomized participants who had baseline and post baseline JSN data. All randomized participants who had baseline and post baseline BES data. Linear extrapolation was used to impute missing data.||units on a scale||Standard Error|Least Squares Mean
859003|NCT01695239|Secondary|Percentage of Participants Achieving ACR20 Response at Week 12|ACR20 response is defined as a ≥20% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.|Week 12|All randomized participants. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.||percentage of participants|||Number
858995|NCT01695239|Secondary|Change From Baseline in Fatigue Severity Numeric Rating Scale (NRS) Score (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO])|The Fatigue Severity NRS is a participant-administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing “no fatigue” and 10 representing “as bad as you can imagine.” Participants rated their fatigue (feeling tired or worn out) by circling the 1 number that described their worst level of fatigue during the past 24 hours. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.|Baseline, Week 24|All randomized participants who had baseline and post baseline fatigue NRS data.||units on a scale||Standard Error|Least Squares Mean
858996|NCT01695239|Secondary|Change From Baseline in Itching Severity Using the Itch Numeric Rating Scale (NRS) (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO])|The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing “no itch” and 10 representing “worst itch imaginable.” Overall severity of a participant's itching from psoriasis was indicated by circling the number that best described the worst level of itching in the past 24 hours. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.|Baseline, Week 12|All randomized participants who had baseline psoriatic lesion(s) involving >=3% BSA, baseline itch NRS score and post baseline itch NRS score.||units on a scale||Standard Error|Least Squares Mean
858997|NCT01695239|Secondary|Change From Baseline in Leeds Enthesitis Index (LEI)|The LEI was developed specifically for use in PsA. It measures enthesitis at 6 sites (lateral epicondyle, left and right; medial femoral condyle, left and right; Achilles tendon insertion, left and right). Each site was assigned a score of 0 (absent) or 1 (present); the results from each site were then added to produce a total score (range 0 to 6). LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, treatment by visit interaction.|Baseline, Week 12|All randomized participants who had baseline enthesitis, baseline LEI score and post baseline LEI score.||units on a scale||Standard Error|Least Squares Mean
858998|NCT01695239|Secondary|Percentage of Participants Achieving Psoriasis Area and Severity Index 75%, 90%, 100% (PASI 75, 90, 100)|The PASI is an index that combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 75 were defined as having an improvement of at least 75% in the PASI compared to their baseline measures. Participants achieving PASI 90 were defined as having an improvement of ≥90% in the PASI score compared to baseline. Participants achieving PASI 100 were defined as having an improvement of 100% in the PASI score compared to baseline.|Week 12|All randomized participants with baseline psoriatic lesion(s) involving ≥3% BSA. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.||percentage of participants|||Number
858999|NCT01695239|Secondary|Change From Baseline in Modified Total Sharp Score (mTSS) (Efficacy of Ixekizumab in Participants With Active Psoriatic Arthritis. Measure: Modified Total Sharp Score [mTSS])|The mTSS measures the extent of bone erosions (20 joints per hand and 12 joints per foot) and joint space narrowing (20 joints per hand and 6 joints per foot), with higher scores representing greater damage. An increase from baseline represents disease progression and / or joint worsening. Scores range from 0-528. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, and baseline cDMARD experience, visit, treatment by visit interaction.|Baseline, Week 24|All randomized participants with baseline and post baseline mTSS data.||units on a scale||Standard Error|Least Squares Mean
859000|NCT01695239|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO])|HAQ-DI is a participant reported questionnaire that measures disease-associated disability (physical function). It consists of 24 questions with 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other daily activities. The disability section scores the participant’s self-perception on the degree of difficulty (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do), covering the 8 domains. The HAQ-DI is a composite ranging from 0-3 with lower scores indicating less functional disability. The reported use of special aids or devices and/or the need for assistance of another person to perform these activities is assessed. Least Square (LS) mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline score, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment-by-visit interaction.|Baseline, Week 24|All randomized participants with baseline and post baseline HAQ-DI data.||units on a scale||Standard Error|Least Squares Mean
859001|NCT01695239|Secondary|Percentage of Participants Achieving American College of Rheumatology 70 (ACR70) Score at Week 24|ACR70 response is defined as a ≥70% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.|Week 24|All randomized participants. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.||percentage of participants|||Number
859002|NCT01695239|Secondary|Percentage of Participants Achieving American College of Rheumatology 50 (ACR50) Response at Week 24|ACR50 response is defined as a ≥50% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.|Week 24|All randomized participants. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.||percentage of participants|||Number
859018|NCT01606124|Secondary|Tolerability as Estimated Using the Percent Dose of Treatment Received at 6 Months|Tolerability as estimated using the percent dose of treatment received for each patient by dividing the total dose received by the targeted (i.e., protocol specified) total dose.|6 months|||percentage of targeted dose||Standard Deviation|Mean
859004|NCT01695239|Primary|Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response at Week 24 (Efficacy of Ixekizumab in Participants With Active Psoriatic Arthritis. Measure: American College of Rheumatology 20 Index [ACR20])|ACR20 response is defined as a ≥20% improvement from baseline for tender joint count (TJC) and swollen joint count (SJC) and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain visual analog scale (VAS), Participant's Global Assessment of Disease Activity VAS (PatGA), Physician's Global Assessment of the Disease Activity VAS (PGA), Participant's Assessment of Physical Function using the Health Assessment Questionnaire Disability Index (HAQ-DI), or Acute Phase Reactant as measured by high sensitivity C-reactive protein (hs-CRP).|Week 24|All randomized participants. Nonresponder Imputation (NRI) is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.||percentage of participants|||Number
859005|NCT01639443|Secondary|Cost Comparisons|For cost comparisons, the investigators will aggregate total provider overtime costs for colonoscopies performed. Cost is reported per day.|After 12 months of running study in clinic|These 1672 patients are a subset of all patients who were enrolled in this study. We dropped data on a first wave of participants (69 Fast-tracked and 3294 Controls) because of problems incorporating recruitment strategy into clinic. However, data from these individuals was used to build predictive model.||dollars||Standard Deviation|Mean
859006|NCT01639443|Secondary|Length of Workday|Length of Workday in hours (comparing days with Fast-Tracked Appointments to Control days without)|After 12 months of running study in clinic|These 1672 patients are a subset of all patients who were enrolled in this study. We dropped data on a first wave of participants (69 Fast-tracked and 3294 Controls) because of problems incorporating recruitment strategy into clinic. However, data from these individuals was used to build predictive model.||hours||Standard Deviation|Mean
859007|NCT01639443|Secondary|Advanced Adenoma Detection/Cecal Intubation Rates|The investigators will compare daily advanced adenomatous polyp detection and daily cecal intubation rates between groups.|After 20 months of running study in clinic|We only collected data on polyp detection for the first half of our Fast-tracked participants and all Controls seen over the same time period (4897 in total).||Number of Polyps Detected per patient||Standard Deviation|Mean
859008|NCT01639443|Secondary|"Daily Service Denials (Bumps)"|The investigators will compare the number of patients bumped per day between scheduling approaches|After 12 months of running study in clinic|These 1672 patients are a subset of all patients who were enrolled in this study. We dropped data on a first wave of participants (69 Fast-tracked and 3294 Controls) because of problems incorporating recruitment strategy into clinic. However, data from these individuals was used to build predictive model.||participants|||Number
859009|NCT01639443|Secondary|Scheduling-to-procedure Lag Time|The investigators will calculate the mean daily lag time for all colonoscopy and upper endoscopies performed per day|After 12 months of running study in clinic|These 1672 patients are a subset of all patients who were enrolled in this study. We dropped data on a first wave of participants (69 Fast-tracked and 3294 Controls) because of problems incorporating recruitment strategy into clinic. However, data from these individuals was used to build predictive model.||days||Standard Deviation|Mean
859010|NCT01639443|Primary|Percentage of GI Clinic Capacity Filled|Investigators' primary objective will be to evaluate the impact of no-show predictive overbooking on percentage of the GI endoscopy clinic that are filled on a given day. Days where at least one Fast-tracked patient attended an appointment were compared to days where only Control patients attended appointments. Percentage of GI Clinic Capacity is calculated as the number of appointments completed divided by number of appointment spots available on a given day. This percentage was compared between Fast-tracked days and Control days, using data from 1672 patients.|After 12 months of running study in clinic|These 1672 patients are a subset of all patients who were enrolled in this study. We dropped data on a first wave of participants (69 Fast-tracked and 3294 Controls) because of problems incorporating recruitment strategy into clinic. However, data from these individuals was used to build predictive model.||percentage of clinic capacity filled||Standard Deviation|Mean
859011|NCT01618162|Secondary|Number of Adverse Events (AEs)|An AE was any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. Reported values are hypoglycemia event rate per 100 PYE.|After 26 weeks of treatment|Safety analysis set.||event rate per 100 PYE|||Number
859012|NCT01618162|Secondary|Number of Treatment Emergent (Confirmed) Hypoglycaemic Episodes|"An event was treatment emergent if the onset of the episode occurs after the first administration of trial product and no later than 7 days after last trial product administration.
Confirmed hypoglycaemic episodes were defined as hypoglycaemic episodes that were either severe or minor.
Minor hypoglycaemic episodes were defined as:
An episode with symptoms consistent with hypoglycaemia and confirmed by blood glucose value <2.8 mmol/L (50 mg/dL) or plasma glucose <3.1 mmol/L (56 mg/dL) and which was handled by the subject himself/herself.
Any asymptomatic PG value <3.1 mmol/L (56 mg/dL) or blood glucose value <2.8 mmol/L (50 mg/dL).
Severe hypoglycemia was defined as an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.
Reported values are hypoglycemia event rate per 100 patient-years of exposure (PYE)."|After 26 weeks of treatment|Safety analysis set included all subjects receiving at least one dose of the trial product.||event rate per 100 PYE|||Number
859013|NCT01618162|Secondary|Change From Baseline in Body Weight|Change from baseline in body weight at week 26.|Week 0, week 26|Full analysis set.||kilogram||Standard Deviation|Mean
859014|NCT01618162|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|Change from baseline in FPG at week 26.|Week 0, week 26|Full analysis set. Number of subjects analyzed=subjects with data available for FPG.||mmol/L||Standard Deviation|Mean
859015|NCT01618162|Secondary|Responders Achieving Pre-defined Target: HbA1c Below or Equal to 6.5% (48 mmol/Mol)|Percentage of subjects having HbA1c below 6.5% at week 26|Week 26|Full analysis set.||percentage of subjects|||Number
859016|NCT01618162|Secondary|Responders Achieving Pre-defined Target: HbA1c Below 7.0% (53 mmol/Mol)|Percentage of subjects having HbA1c below 7% at week 26.|Week 26|Full analysis set.||percentage of subjects|||Number
859017|NCT01618162|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Change in HbA1c from baseline to 26 weeks.|Week 0, Week 26|Full analysis set.||percentage of glycosylated haemoglobin||Standard Deviation|Mean
859066|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF)||6 months|||percent||Standard Deviation|Mean
859019|NCT01606124|Primary|Percent Change in Rectal ACF, Pre- and Post Intervention at 6 Months|The primary endpoint is based on a modified intent-to-treat procedure which includes all patients with baseline and 6-month ACF data. The percent change in rectal ACF (≤ 15 cm from the anal verge) for each patient is calculated as their Pre-Registration number of rectal ACF minus the number of rectal ACF present at the 6-month post-intervention exam, divided by the number of rectal ACF present at Pre-Registration times 100.|6 months|Patients with baseline and 6-month ACF data were included in this analysis.||percentage change||Standard Deviation|Mean
859020|NCT01544179|Secondary|Time to Worsening in Lung Cancer Subscale|A worsening is defined as a change from baseline of ≤ -2 (0-28 score range). Measured by the Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) questionnaire|At visits 2-8, then every 6 weeks until progression, at progression or treatment discontinuation, and every 8 weeks after progression until PFS analysis data cut off.|Evaluable-for-QoL||Weeks||95% Confidence Interval|Median
859021|NCT01544179|Secondary|Improvement in Lung Cancer Subscale|An improvement is defined as a change from baseline of ≥ +2 (0-28 score range). Measured by the Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) questionnaire|At visits 2-8, then every 6 weeks until progression, at progression or treatment discontinuation, and every 8 weeks after progression until PFS analysis data cut off.|Evaluable-for-QoL||Number of participants improving|||Number
859022|NCT01544179|Secondary|Time to Worsening in FACT-L Total Score|A worsening is defined as a change from baseline of ≤ -6 (0-136 score range). Measured by the Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) questionnaire|At visits 2-8, then every 6 weeks until progression, at progression or treatment discontinuation, and every 8 weeks after progression until PFS analysis data cut off.|Evaluable-for-QoL||Weeks||95% Confidence Interval|Median
859023|NCT01544179|Secondary|Improvement in FACT-L Total Score|An improvement is defined as a change from baseline of ≥ +6 (0-136 score range). Measured by the Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) questionnaire|At visits 2-8, then every 6 weeks until progression, at progression or treatment discontinuation, and every 8 weeks after progression until PFS analysis data cut off.|Evaluable-for-QoL||Number of patients improving|||Number
859024|NCT01544179|Secondary|Time to Worsening in Trial Outcome Index|A worsening is defined as a change from baseline of ≤ -6 (0-84 score range). Measured by the Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) questionnaire|At visits 2-8, then every 6 weeks until progression, at progression or treatment discontinuation, and every 8 weeks after progression until PFS analysis data cut off.|Evaluable-for-QoL||Weeks||95% Confidence Interval|Median
859025|NCT01544179|Secondary|Improvement in Trial Outcome Index|An improvement is defined as a change from baseline of ≥ +6 (0-84 score range). Measured by the Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) questionnaire.|At visits 2-8, then every 6 weeks until progression, at progression or treatment discontinuation, and every 8 weeks after progression until PFS analysis data cut off.|Evaluable-for-QoL||Number of participants improving|||Number
859026|NCT01544179|Secondary|Disease Control Rate (DCR)|DCR is the percentage of patients who achieve disease control at 6 weeks following randomisation. DCR is defined as a Best Objective Response (BOR) of Complete Response, Partial Response or Stable Disease, as defined by Response Evaluation Criteria in Solid Tumours (RECIST v1.1) for target lesions and assessed by CT or MRI. CR, Disappearance of all target lesions; PR, ≥30% decrease in the sum of the longest diameter of target lesions; SD, neither sufficient shrinkage to qualify for PR not sufficient increase to qualify for Progressive Disease (PD); PD, ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, and the sum must have shown an absolute increase of ≥5mm|Radiologic evaluations were carried out every 6 weeks from randomization until documented progression, withdrawal of consent, loss to follow up, death or the primary data cut off (DCO) for the analysis.|Full analysis set||Percentage of Participants|||Number
859027|NCT01544179|Secondary|Objective Response Rate (ORR) (Site Read Data)|ORR rate is defined as the number (%) of subjects with at least one visit response of Complete Response (CR) or Partial Response (PR) , as defined by Response Evaluation Criteria in Solid Tumours (RECIST v1.1) for target lesions and assessed by CT or MRI. CR, Disappearance of all target lesions; PR, ≥30% decrease in the sum of the longest diameter of target lesions. Data obtained up until progression, or last evaluable assessment in the absence of progression, was included in the assessment of ORR.|Radiologic evaluations were carried out every 6 weeks from randomization until documented progression, withdrawal of consent, loss to follow up, death or the primary data cut off (DCO) for the analysis.|Full analysis set||Percentage of Participants|||Number
859028|NCT01544179|Secondary|Median Overall Survival (OS) at Time of PFS Analysis||Baseline and then every 6 weeks after randomization until objective disease progression. OS is then assessed 8 weekly following PFS progression up to PFS analysis data cut off.|Full analysis set||Months||95% Confidence Interval|Median
859029|NCT01544179|Secondary|Overall Survival (OS)|OS is the time from the date of randomisation until death due to any cause. Any subject not known to have died at the time of analysis will be censored based on the last recorded date on which the subject was known to be alive.|Following progression survival data was collected every 8 weeks until documentation of death, withdrawal of consent, loss to follow-up or the final data cut-off, whichever occurs first.|Full analysis set||Number of patients with an OS event|||Number
859030|NCT01544179|Primary|Median Progression-Free Survival (Site Read, Investigator Assessment)|PFS is the time from randomisation until the date of objective disease progression as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) or death (by any cause in the absence of progression). Progression is defined using RECIST (v1.1), as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm.|Radiologic evaluations were carried out every 6 weeks from randomization until documented progression, withdrawal of consent, loss to follow up, death or the primary data cut off (DCO) for the analysis, assessed up to 50 weeks|Full analysis set (all treated patients)||Months||95% Confidence Interval|Median
859067|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF)||30 days|||percent||Standard Deviation|Mean
859150|NCT01141712|Secondary|Time to Progression After CR|This will be assessed in patients with CR. Patients are considered failure for this end point if they relapse after complete remission. Surviving patients with no history of relapse/progression are censored at time of last follow-up.|Year 2|No data collected to analyze this outcome measure|||||
859031|NCT01544179|Primary|Progression-Free Survival (Site Read, Investigator Assessment)|PFS is the time from randomisation until the date of objective disease progression as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) or death (by any cause in the absence of progression). Progression is defined using RECIST (v1.1), as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm.|Radiologic evaluations were carried out every 6 weeks from randomization until documented progression, withdrawal of consent, loss to follow up, death or the primary data cut off (DCO) for the analysis, assessed up to 50 weeks|Full analysis set (all treated patients)||Patients with a progression event|||Number
859032|NCT01512693|Secondary|Apparent Terminal Half-life (t1/2) of MK-0822 After Single Dose|Apparent terminal half-life is the time required to divide the plasma (serum) concentration by two after reaching pseudo-equilibrium. (Note: it is not the time required to eliminate half the administered dose.) For healthy and moderate hepatic insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of t1/2. Results are presented using harmonic mean and jackknife standard deviation.|Pre-dose and 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, 240, and 336 hours postdose|The per protocol population consisted of all participants who complied with the protocol sufficiently to ensure that results will likely exhibit the effects of treatment according to the underlying scientific model.||hr||Standard Deviation|Mean
859033|NCT01512693|Secondary|Time to Maximum Concentration (Tmax) of MK-0822 After Single Dose|For healthy and moderate hepatic insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of Tmax.|Pre-dose and 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, 240, and 336 hours postdose|The per protocol population consisted of all participants who complied with the protocol sufficiently to ensure that results will likely exhibit the effects of treatment according to the underlying scientific model.||hr||Full Range|Median
859034|NCT01512693|Secondary|Maximum Concentration (Cmax) of MK-0822 After Single Dose|For healthy and moderate hepatic insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of Cmax.|Pre-dose and 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, 240, and 336 hours postdose|The per protocol population consisted of all participants who complied with the protocol sufficiently to ensure that results will likely exhibit the effects of treatment according to the underlying scientific model.||nM||95% Confidence Interval|Least Squares Mean
859035|NCT01512693|Primary|Area Under the Concentration-time Curve of MK-0822 From Time 0 to Infinity (AUC0-∞) After Single Dose|For healthy and moderate hepatic insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of AUC0-∞ (Total AUC). AUC0-∞ is a measure of total drug exposure.|Pre-dose and 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, 240, and 336 hours postdose|The per protocol population consisted of all participants who complied with the protocol sufficiently to ensure that results will likely exhibit the effects of treatment according to the underlying scientific model.||μM*hr||95% Confidence Interval|Least Squares Mean
859036|NCT01468896|Secondary|Time to Disease Progression (Phase II)|The Kaplan-Meier method will be used to estimate time to progression distributions.|From date of registration to date of progression, assessed up to 1 year|||months||95% Confidence Interval|Median
859037|NCT01468896|Secondary|Proportion of Patients Who Are Progression-free (Phase I)|Summarized by simple descriptive summary statistics. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|6 months|||proportion of patients|||Number
859038|NCT01468896|Secondary|Overall Survival (Phase II)|The Kaplan-Meier method will be used to estimate overall survival distribution.|From the date of registration to date of death, assessed up to 1 year|||months||95% Confidence Interval|Median
859039|NCT01468896|Secondary|Number of Confirmed Clinical Responses (Phase I)|Summarized by simple descriptive summary statistics. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 6 months|||Participants|||Count of Participants
859040|NCT01468896|Secondary|Induction of Systemic Plasma Levels of Interferon-gamma|Explores graphically how changes in this marker differ between those with versus without an objective response to therapy as well as other potential factors.|Baseline up to day 50|Unable to compare the plasma levels of interferon-gamma between those with versus without an objective response to therapy due to no objective response seen for Phase I or Phase II patients.|||||
859041|NCT01468896|Primary|Proportion of Patients Who Have Any Response to Treatment (Complete Response or Partial Response), Determined According to Response Evaluation Criteria in Solid Tumors (Phase II)|The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Ninety percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 6 months|||proportion of patients|||Number
859042|NCT01468896|Primary|Number of Dose-limiting Toxicity Incidents to Determine the Maximum Tolerated Dose of IL-12, Evaluated Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase I)||14 days|||Dose limiting toxicities|||Number
859043|NCT01437098|Secondary|Quality of Life Assessment Using SF-36 Questionnaire - Physical Component Summary (Paired Change From Baseline) (Q of L)|The SF-36 assessment was used to evaluate subject Quality of life (QoL) by assessing change in physical function and general health status. The SF-36 v2TM Scoring Program2,3 was used to convert raw scores ranging from 0 to 100 into norm-based scores, allowing direct comparison to the reference values for the Japanese population. A norm-based score of less than 50 was interpreted as below average when compared to the Japanese population whereas norm-based scores greater than 50 were interpreted as above average.|Baseline to 36 Months|||Points||Inter-Quartile Range|Median
859171|NCT01002742|Secondary|Incidence of Epstein-Barr Virus (EBV)-Associated Lymphoma||12 months|||participants|||Number
859044|NCT01437098|Secondary|Quality of Life Assessment Using SF-36 Questionnaire - Physical Component Summary (Paired Change From Baseline) (Q of L)|The SF-36 assessment was used to evaluate subject Quality of life (QoL) by assessing change in physical function and general health status. The SF-36 v2TM Scoring Program2,3 was used to convert raw scores ranging from 0 to 100 into norm-based scores, allowing direct comparison to the reference values for the Japanese population. A norm-based score of less than 50 was interpreted as below average when compared to the Japanese population whereas norm-based scores greater than 50 were interpreted as above average.|Baseline to 24 Months|||Points||Inter-Quartile Range|Median
859045|NCT01437098|Secondary|Quality of Life Assessment Using SF-36 Questionnaire - Physical Component Summary (Paired Change From Baseline) (Q of L)|The SF-36 assessment was used to evaluate subject Quality of life (QoL) by assessing change in physical function and general health status. The SF-36 v2TM Scoring Program2,3 was used to convert raw scores ranging from 0 to 100 into norm-based scores, allowing direct comparison to the reference values for the Japanese population. A norm-based score of less than 50 was interpreted as below average when compared to the Japanese population whereas norm-based scores greater than 50 were interpreted as above average.|Baseline to 12 months|||Points||Inter-Quartile Range|Median
859046|NCT01437098|Secondary|Quality of Life Assessment Using SF-36 Questionnaire - Physical Component Summary (Paired Change From Baseline) (Q of L)|The SF-36 assessment was used to evaluate subject Quality of life (QoL) by assessing change in physical function and general health status. The SF-36 v2TM Scoring Program2,3 was used to convert raw scores ranging from 0 to 100 into norm-based scores, allowing direct comparison to the reference values for the Japanese population. A norm-based score of less than 50 was interpreted as below average when compared to the Japanese population whereas norm-based scores greater than 50 were interpreted as above average.|Baseline to 6 months|||Points||Inter-Quartile Range|Median
859047|NCT01437098|Secondary|Quality of Life Assessment Using SF-36 Questionnaire - Physical Component Summary (Paired Change From Baseline) (Q of L)|The SF-36 assessment was used to evaluate subject Quality of life (QoL) by assessing change in physical function and general health status. The SF-36 v2TM Scoring Program2,3 was used to convert raw scores ranging from 0 to 100 into norm-based scores, allowing direct comparison to the reference values for the Japanese population. A norm-based score of less than 50 was interpreted as below average when compared to the Japanese population whereas norm-based scores greater than 50 were interpreted as above average.|Baseline to 30 days|The implanted cohorts that had non-missing data at this time point were analyzed. Implanted subjects that had Q of L available at this visit were analyzed. Not everyone followed to this visit had this measurement. This is true of all other echo data results, and explains if the number is different from the Number of Participants Analyzed.||Points||Inter-Quartile Range|Median
859048|NCT01437098|Secondary|Valve-related Deaths||0 day to 36 months|||prob of freedom from event @ 1095 days|||Number
859049|NCT01437098|Secondary|Valve-related Deaths||0 day to 24 months|||prob of freedom from event @ 730 days|||Number
859050|NCT01437098|Secondary|Valve-Related Deaths||0 day to 12 months|||prob of freedom from event @ 365 days|||Number
859051|NCT01437098|Secondary|Valve-related Deaths||0 day to 6 months|||prob of freedom from event @ 183 days|||Number
859052|NCT01437098|Secondary|Valve-related Deaths||0 day to 30 days|||prob of freedom from event @ 30 days|||Number
859053|NCT01437098|Secondary|Repeat Hospitalization||0 day to 36 months|||prob of freedom from event @ 1095 days|||Number
859054|NCT01437098|Secondary|Repeat Hospitalization||0 day to 24 months|||prob of freedom from event @ 730 days|||Number
859055|NCT01437098|Secondary|Repeat Hospitalization||0 day to 12 months|||prob of freedom from event @ 365 days|||Number
859056|NCT01437098|Secondary|Repeat Hospitalization||0 day to 6 months|||prob of freedom from event @ 183 days|||Number
859057|NCT01437098|Secondary|Repeat Hospitalization||0 day to 30 days|||prob of freedom from event @ 30 days|||Number
859058|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Valve Regurgitation (Transvalvular & Paravalvular) (Total AR)||36 months|The implanted cohorts that had non-missing data at this time point were analyzed. Implanted subjects that had LVEF measurement available at 36 months were analyzed. Not everyone followed to 36 months had this measurement. This is true of all other echo data results, and explains if the number is different from the Number of Participants Analyzed.||percentage of participants|||Number
859059|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Valve Regurgitation (Transvalvular & Paravalvular) (Total AR)||24 months|The implanted cohorts that had non-missing data at this time point were analyzed. Implanted subjects that had Total AR available at 24 months were analyzed. Not everyone followed to 24 months had this measurement. This is true of all other echo data results, and explains if the number is different from the Number of Participants Analyzed.||percentage of participants|||Number
859060|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Valve Regurgitation (Transvalvular & Paravalvular) (Total AR)||12 months|||percentage of participants|||Number
859061|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Valve Regurgitation (Transvalvular & Paravalvular) (Total AR)||6 months|||percentage of participants|||Number
859062|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Valve Regurgitation (Transvalvular & Paravalvular) (Total AR)||30 days|||percentage of participants|||Number
859063|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF)||36 months|The implanted cohorts that had non-missing data at this time point were analyzed. Implanted subjects that had LVEF measurement available at 36 months were analyzed. Not everyone followed to 36 months had this measurement. This is true of all other echo data results, and explains if the number is different from the Number of Participants Analyzed.||percent||Standard Deviation|Mean
859064|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF)||24 months|The implanted cohorts that had non-missing data at this time point were analyzed. Implanted subjects that had LVEF measurement available at 24 months were analyzed. Not everyone followed to 24 months had this measurement. This is true of all other echo data results, and explains if the number is different from the Number of Participants Analyzed.||percent||Standard Deviation|Mean
859065|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF)||12 months|||percent||Standard Deviation|Mean
859068|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance- Effective Orifice Area (EOA)||36 months|The implanted cohorts that had non-missing data at this time point were analyzed. Implanted subjects that had LVEF measurement available at 36 months were analyzed. Not everyone followed to 36 months had this measurement. This is true of all other echo data results, and explains if the number is different from the Number of Participants Analyzed.||cm²||Standard Deviation|Mean
859069|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance- Effective Orifice Area (EOA)||24 months|The implanted cohorts that had non-missing data at this time point were analyzed. Implanted subjects that had EOA measurement available at 24 months were analyzed. Not everyone followed to 24 months had this measurement. This is true of all other echo data results, and explains if the number is different from the Number of Participants Analyzed.||cm²||Standard Deviation|Mean
859070|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance- Effective Orifice Area (EOA)||12 months|||cm²||Standard Deviation|Mean
859071|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance- Effective Orifice Area (EOA)||6 months|||cm²||Standard Deviation|Mean
859072|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance- Effective Orifice Area (EOA)||30 days|||cm²||Standard Deviation|Mean
859073|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Mean Gradient||36 months|The implanted cohorts that had non-missing data at this time point were analyzed. Implanted subjects that had LVEF measurement available at 36 months were analyzed. Not everyone followed to 36 months had this measurement. This is true of all other echo data results, and explains if the number is different from the Number of Participants Analyzed.||mmHg||Standard Deviation|Mean
859074|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Mean Gradient||24 months|The implanted cohorts that had non-missing data at this time point were analyzed. Implanted subjects that had mean gradients available at 24 months were analyzed. Not everyone followed to 24 months had this measurement. This is true of all other echo data results, and explains if the number is different from the Number of Participants Analyzed.||mmHg||Standard Deviation|Mean
859075|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Mean Gradient||12 months|||mmHg||Standard Deviation|Mean
859076|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance- Mean Gradient||6 months|||mmHg||Standard Deviation|Mean
859077|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Mean Gradient||30 days|||mmHg||Standard Deviation|Mean
859078|NCT01437098|Secondary|Procedural Success, Defined as Device Success and Absence of In-hospital MACCE.||after procedure or discharge|||percentage of participants|||Number
859079|NCT01437098|Secondary|Device Success as Defined in the Description.|"successful vascular access, delivery and deployment of the device, and successful retrieval of the delivery system
correct position of the device in the proper anatomical location (placement in the annulus with no impedance on device function)
Intended performance of the prosthetic valve (aortic valve area >1.2 cm² (by echocardiography using the continuity equation) and mean aortic valve gradient < 20 mmHg or peak velocity < 3 m/sec, without moderate or severe prosthetic valve AR)
Only one valve implanted in the proper anatomical location"|after procedure or discharge|The AT cohort that went through an index procedure were analyzed for Device Success. Also, all components that went into the success measures had to be non-missing. Therefore n=53.||percentage of participants|||Number
859080|NCT01437098|Secondary|Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)|"MACCE is defined as a composite of:
all-cause death
myocardial infarction (MI)
all stroke, and
reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)"|0 day to 36 months|The Kaplan-Meier Method was used to calculate the number.||prob of freedom from event at 1095 days|||Number
859081|NCT01437098|Secondary|Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)|"MACCE is defined as a composite of:
all-cause death
myocardial infarction (MI)
all stroke, and
reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)"|0 day to 24 months|The Kaplan-Meier Method was used to calculate the number.||prob of freedom from event at 730 days|||Number
859082|NCT01437098|Secondary|Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)|"MACCE is defined as a composite of:
all-cause death
myocardial infarction (MI)
all stroke, and
reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)"|0 day to 12 months|The Kaplan-Meier Method was used to calculate the number.||prob of freedom from event @ 365 days|||Number
859083|NCT01437098|Secondary|Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)|"MACCE is defined as a composite of:
all-cause death
myocardial infarction (MI)
all stroke, and
reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)"|0 day to 6 months|The Kaplan-Meier Method was used to calculate the number.||prob of freedom from event @ 183 days|||Number
859084|NCT01437098|Secondary|Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)|"MACCE is defined as a composite of:
all-cause death
myocardial infarction (MI)
all stroke, and
reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)"|0 day to 30 days|The Kaplan-Meier Method was used to calculate the number.||prob of freedom from event @ 30 days|||Number
859085|NCT01437098|Secondary|NYHA Classification Over Time|"NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA) Class I Subject with cardiac disease but without resulting limitations of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain.
Class II Subjects with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III Subjects with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation, dyspnea, or anginal pain.
Class IV Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|36 Months|||percentage of participants|||Number
859086|NCT01437098|Secondary|NYHA Classification Over Time|"NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA) Class I Subject with cardiac disease but without resulting limitations of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain.
Class II Subjects with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III Subjects with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation, dyspnea, or anginal pain.
Class IV Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|24 Months|||percentage of participants|||Number
859087|NCT01437098|Secondary|NYHA Classification Over Time|"NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA) Class I Subject with cardiac disease but without resulting limitations of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain.
Class II Subjects with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III Subjects with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation, dyspnea, or anginal pain.
Class IV Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|12 Months|||percentage of participants|||Number
859088|NCT01437098|Secondary|NYHA Classification Over Time|"NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA) Class I Subject with cardiac disease but without resulting limitations of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain.
Class II Subjects with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III Subjects with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation, dyspnea, or anginal pain. Class IV Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|6 months|||percentage of participants|||Number
859089|NCT01437098|Secondary|NYHA Classification Over Time|"NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA) Class I Subject with cardiac disease but without resulting limitations of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain.
Class II Subjects with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III Subjects with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation, dyspnea, or anginal pain. Class IV Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|30 days|NYHA denominators included deaths (n=2). Taken deaths out, you have n=51 at 30 days.||percentage of participants|||Number
859090|NCT01437098|Primary|Composite Success of Improvement in New York Heart Association (NYHA) Class and a Performance Goal for Effective Orifice Area (EOA).|The primary endpoint was defined as the proportion of implanted subjects with improvement of at least 1 NYHA class from baseline to 6 months and EOA greater than 1.2 cm² at 6 months.|baseline and 6 months|All subjects implanted with the MDT-2111 device.||percentage of participants|||Number
859091|NCT01392573|Secondary|Change in Body Weight|Observed mean change from baseline in body weight after 26 Weeks of treatment.|Week 0, week 26|Full analysis set. Missing data was imputed using LOCF.||kg||Standard Deviation|Mean
859092|NCT01392573|Primary|Change From Baseline in HbA1c (Glycosylated Haemoglobin)|Observed mean change from baseline in HbA1c after 26 Weeks of treatment.|Week 0, week 26|Full analysis set. Missing data was imputed using last observation carried forward (LOCF).||percentage of glycosylated haemoglobin||Standard Deviation|Mean
859093|NCT01387282|Secondary|Change in Body Weight|Change in body weight (BW) from baseline overall (i.e., over 12 weeks) for the MITT Population.|Change in Body Weight from Baseline Over 12 Weeks|Modified Intent-to-Treat Population||kg||Standard Error|Least Squares Mean
859094|NCT01387282|Secondary|Change in FACIT-F Fatigue Domain Score|"The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) fatigue domain is a 13-item scale that is part of the Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System. Each item is answered on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much).
The 13-items are summed together to obtain the domain score. Note that negatively phrased questions are reverse scored so that higher scores always represent improvement/less symptom burden. The total possible score for the FACIT-F fatigue domain ranges from 0 (worst) to 52 (best)."|Change in FACIT-F Fatigue Domain Score from Baseline Over 12 Weeks|Modified Intent-to-Treat Population||scores on a scale||Standard Error|Least Squares Mean
859095|NCT01387282|Secondary|Change in A/CS Domain Score|"The Functional Assessment of Anorexia/Cachexia Treatment (FAACT) Additional Concerns Subscale (A/CS domain) is a 12-item scale that is part of the Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System. Each item is answered on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much).
The 12-items are summed together to obtain the domain score. Note that negatively phrased questions are reverse scored so that higher scores always represent improvement/less symptom burden. The total possible score for the A/CS domain ranges from 0 (worst) to 48 (best)."|Change in FAACT A/CS Domain Score from Baseline Over 12 Weeks|Modified Intent-to-Treat Population||scores on a scale||Standard Error|Least Squares Mean
859126|NCT01352221|Secondary|Proportion of Subjects That Achieved ≥2 g/dL Change From Baseline in Hb Concentration at Week 12 (Full Analysis Set, FAS)|Logistic regression analysis of proportion of subjects that achieved ≥2 g/dL change from baseline in Hb concentration at Week 12 in the double-blind phase|Baseline to Week 12 - double-blind phase|FAS||Participants|||Count of Participants
859172|NCT01002742|Secondary|Incidence of Systemic Infections|Number of participants that experienced at least one infection.|6 Months|||participants|||Number
859096|NCT01387282|Primary|Change in Handgrip Strength|Change in Handgrip Strength (HGS) of the non-dominant hand from baseline over 12 weeks for the ITT Population. Change from baseline over 12 weeks was defined as the average of the change from baseline at Week 6 and the change from baseline at Week 12.|Change in Handgrip Strength of the Non-Dominant Hand from Baseline Over 12 Weeks|Intent-to-Treat Population. Some patients in the ITT population were excluded from the primary LBM/HGS analysis (i.e., multiple imputations/ranking method) if they survived to Week 12 but missed their baseline covariates including LBM, HGS, or ECOG OR had Week 6 and Week 12 outcomes that were outside the visit windows.||kg||95% Confidence Interval|Median
859097|NCT01387282|Primary|Change in Lean Body Mass|Change in Lean Body Mass (LBM) from baseline over 12 weeks for the ITT Population. Change from baseline over 12 weeks was defined as the average of the change from baseline at Week 6 and the change from baseline at Week 12.|Change in Lean Body Mass from Baseline Over 12 Weeks|Intent-to-Treat Population. Some patients in the ITT population were excluded from the primary LBM/HGS analysis (i.e., multiple imputations/ranking method) if they survived to Week 12 but missed their baseline covariates including LBM, HGS, or ECOG OR had Week 6 and Week 12 outcomes that were outside the visit windows.||kg||95% Confidence Interval|Median
859098|NCT01387269|Secondary|Change in Body Weight|Change in body weight (BW) from baseline overall (i.e., over 12 weeks) for the MITT Population.|Change in Body Weight from Baseline Over 12 Weeks|Modified Intent-to-Treat Population||kg||Standard Error|Least Squares Mean
859099|NCT01387269|Secondary|Change in FACIT-F Fatigue Domain Score|"The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) fatigue domain is a 13-item scale that is part of the Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System. Each item is answered on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much).
The 13-items are summed together to obtain the domain score. Note that negatively phrased questions are reverse scored so that higher scores always represent improvement/less symptom burden. The total possible score for the FACIT-F fatigue domain ranges from 0 (worst) to 52 (best)."|Change in FACIT-F Fatigue Domain Score from Baseline Over 12 Weeks|Modified Intent-to-Treat Population||scores on a scale||Standard Error|Least Squares Mean
859100|NCT01387269|Secondary|Change in A/CS Domain Score|"The Functional Assessment of Anorexia/Cachexia Treatment (FAACT) Additional Concerns Subscale (A/CS domain) is a 12-item scale that is part of the Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System. Each item is answered on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much).
The 12-items are summed together to obtain the domain score. Note that negatively phrased questions are reverse scored so that higher scores always represent improvement/less symptom burden. The total possible score for the A/CS domain ranges from 0 (worst) to 48 (best)."|Change in FAACT A/CS Domain Score from Baseline Over 12 Weeks|Modified Intent-to-Treat Population||scores on a scale||Standard Error|Least Squares Mean
859101|NCT01387269|Primary|Change in Handgrip Strength|Change in Handgrip Strength (HGS) of the non-dominant hand from baseline over 12 weeks for the ITT Population. Change from baseline over 12 weeks was defined as the average of the change from baseline at Week 6 and the change from baseline at Week 12.|Change in Handgrip Strength of the Non-Dominant Hand from Baseline Over 12 Weeks|Intent-to-Treat Population. Some patients in the ITT population were excluded from the primary LBM/HGS analysis (i.e., multiple imputations/ranking method) if they survived to Week 12 but missed their baseline covariates including LBM, HGS, or ECOG OR had Week 6 and Week 12 outcomes that were outside the visit windows.||kg||95% Confidence Interval|Median
859102|NCT01387269|Primary|Change in Lean Body Mass|Change in Lean Body Mass (LBM) from baseline over 12 weeks for the ITT Population. Change from baseline over 12 weeks was defined as the average of the change from baseline at Week 6 and the change from baseline at Week 12.|Change in Lean Body Mass from Baseline Over 12 Weeks|Intent-to-Treat Population. Some patients in the ITT population were excluded from the primary LBM/HGS analysis (i.e., multiple imputations/ranking method) if they survived to Week 12 but missed their baseline covariates including LBM, HGS, or ECOG OR had Week 6 and Week 12 outcomes that were outside the visit windows.||kg||95% Confidence Interval|Median
859103|NCT01352221|Other Pre-specified|Change From Baseline in Crohn's Disease Activity Index (CDAI) Score at Week 64 (Full Analysis Set, FAS)|"Change from baseline in Crohn's Disease Activity Index (CDAI) score at Week 64 (FAS), after 12-week double blind phase and 52 weeks open-label ST10 treatment (in participants with CD only).
The CDAI is a research tool used to quantify the symptoms of patients with Crohn's disease. CDAI score can range from 0 to approximately 600. Traditionally, for clinical trials, clinical remission is defined as a CDAI score <150, clinical response is a decrease in CDAI score of 70-100. Mildly active Crohn's disease is defined as a CDAI score 150–220, moderate–severe Crohn's is typically a CDAI 220–450, and severe disease is defined as a CDAI >450."|Baseline to Week 64 - open-label phase|FAS||score on a scale||Full Range|Median
859104|NCT01352221|Other Pre-specified|Change From Baseline in Crohn's Disease Activity Index (CDAI) Score at Week 12 (Full Analysis Set, FAS)|"Change from baseline (randomisation) in Crohn's Disease Activity Index (CDAI) score at Week 12 (FAS), end of double-blind phase (in subjects with CD).
The CDAI is a research tool used to quantify the symptoms of patients with Crohn's disease. CDAI score can range from 0 to approximately 600. Traditionally, for clinical trials, clinical remission is defined as a CDAI score <150, clinical response is a decrease in CDAI score of 70-100. Mildly active Crohn's disease is defined as a CDAI score 150–220, moderate–severe Crohn's is typically a CDAI 220–450, and severe disease is defined as a CDAI >450."|Baseline to Week 12 - double-blind phase|Full Analysis Set (FAS)||score on a scale||Full Range|Median
859105|NCT01352221|Other Pre-specified|Irritable Bowel Disease Questionnaire (IBDQ) Score at Week 64 (Full Analysis Set, FAS)|"Irritable Bowel Disease Questionnaire (IBDQ) score at Week 64 (FAS), after 12-week double-blind phase and 52 weeks of open-label ST10 treatment.
The IBDQ was developed as an activity index for determining the effect of Crohn's disease symptoms on perceived quality of life. It is a 32-item questionnaire with four dimensions: bowel function, emotional status, systemic symptoms and social function. Total IBDQ score ranges from 32 to 224, with higher scores indicating better quality of life. The score of patients in remission usually is between 170 and 190."|Week 64 - open-label phase|FAS||score on a scale||Standard Deviation|Mean
859127|NCT01352221|Secondary|Proportion of Subjects That Achieved ≥1 g/dL Change From Baseline in Hb Concentration at Week 12 (Full Analysis Set, FAS)|Logistic regression analysis of proportion of subjects that achieved ≥1 g/dL change from baseline in Hb concentration at Week 12 in the double-blind phase|Subjects that achieved ≥1 g/dL change from baseline in Hb concentration at Week 12 - double-blind phase|FAS||Participants|||Count of Participants
859106|NCT01352221|Other Pre-specified|Irritable Bowel Disease Questionnaire (IBDQ) Score at Week 12 (Full Analysis Set, FAS)|"Irritable Bowel Disease Questionnaire (IBDQ) score at Week 12 (FAS), end of double-blind phase.
The IBDQ was developed as an activity index for determining the effect of Crohn's disease symptoms on perceived quality of life. It is a 32-item questionnaire with four dimensions: bowel function, emotional status, systemic symptoms and social function. Total IBDQ score ranges from 32 to 224, with higher scores indicating better quality of life. The score of patients in remission usually is between 170 and 190."|Week 12 - double-blind phase|Full Analysis Set (FAS)||score on a scale||Standard Deviation|Mean
859107|NCT01352221|Other Pre-specified|Change in Serum TSAT% From Baseline to Week 64 (Full Analysis Set, FAS)|Change in serum TSAT% from Baseline to Week 64 (Full Analysis Set), after 12-week double-blind phase and 52 weeks open-label ST10 treatment|Baseline to Week 64 - open-label phase|FAS||percent||Standard Deviation|Mean
859108|NCT01352221|Other Pre-specified|Change in Serum Ferritin Concentration From Baseline to Week 64 (Full Analysis Set, FAS)|Change in serum Ferritin concentration from Baseline to Week 64 (FAS), after 12-week double-blind phase and 52 weeks open-label ST10 treatment|Baseline to Week 64 - open-label phase|FAS||μg/dL||Standard Deviation|Mean
859109|NCT01352221|Other Pre-specified|Change in Serum TSAT% From Baseline to Week 12 (Full Analysis Set, FAS)|Change in serum TSAT% from Baseline to Week 12 (FAS), after 12-week double-blind phase|Baseline to Week 12 - double-blind phase|Full Analysis Set (FAS)||percent||Standard Deviation|Mean
859110|NCT01352221|Other Pre-specified|Change in Serum Ferritin Concentration From Baseline to Week 12 (Full Analysis Set, FAS)|Change in serum Ferritin concentration from Baseline to Week 12 (Full Analysis Set), after 12-week double-blind phase|Baseline to Week 12 - double-blind phase|Full Analysis Set (FAS)||μg/dL||Standard Deviation|Mean
859111|NCT01352221|Secondary|Change in Haemoglobin Concentration From Baseline to Week 12 (Full Analysis Set [FAS] LOCF)|ANCOVA sensitivity analysis of the Primary efficacy endpoint analysis on the FAS LOCF - Change in Haemoglobin Concentration from Baseline to Week 12|Baseline to Week 12 - double-blind phase|Full Analysis Set (FAS)||g/dL||Standard Deviation|Mean
859112|NCT01352221|Secondary|Change in Haemoglobin Concentration From Baseline to Week 12 (Per Protocol Analysis Set, PPAS)|ANCOVA sensitivity analysis of the Primary efficacy endpoint analysis on the PPAS - Change in Haemoglobin Concentration from Baseline to Week 12|Baseline to Week 12 - double-blind phase|Full Analysis Set (FAS)||g/dL||Standard Deviation|Mean
859113|NCT01352221|Secondary|Proportion of Subjects That Achieved Haemoglobin Concentration Within Normal Range at Week 64 (Full Analysis Set, FAS)|Proportion of subjects that achieved Haemoglobin Concentration within normal range at Week 64 (Full Analysis Set), after 12-week double-blind phase and 52 weeks of open-label ST10 treatment|Baseline to Week 64 - open-label phase|FAS||Participants|||Count of Participants
859114|NCT01352221|Secondary|Proportion of Subjects That Achieved Haemoglobin Concentration Within Normal Range at Week 36 (Full Analysis Set, FAS)|Proportion of subjects that achieved Haemoglobin Concentration within normal range at Week 36 (Full Analysis Set), after 12-week double-blind phase and 24 weeks of open-label ST10 treatment|Baseline to Week 36 - open-label phase|FAS||Participants|||Count of Participants
859115|NCT01352221|Secondary|Proportion of Subjects That Achieved Haemoglobin Concentration Within Normal Range at Week 16 (Full Analysis Set, FAS)|Proportion of subjects that achieved Haemoglobin Concentration within normal range at Week 16 (Full Analysis Set), after 12-week double-blind phase and first 4 weeks of open-label ST10 treatment|Baseline to Week 16 - open-label phase|FAS||Participants|||Count of Participants
859116|NCT01352221|Secondary|Change in Haemoglobin Concentration From Baseline to Week 64 EOS (Full Analysis Set, FAS)|Change in Haemoglobin Concentration from Baseline to Week 64 EOS (FAS) - Week 64 was re-categorised as Week 64 EOS for those subjects who withdrew from the study early and the ‘Week 64’ visit was outside the visit window of 64 weeks ± 2 days|Baseline to Week 64 EOS - open-label phase|FAS||g/dL||Standard Deviation|Mean
859117|NCT01352221|Secondary|Change in Haemoglobin Concentration From Baseline to Week 64 (Full Analysis Set, FAS)|Change in Haemoglobin Concentration from Baseline to Week 64 (FAS), after 12-week double-blind phase and then 52 weeks of open-label ST10 treatment|Baseline to Week 64 - open-label phase|FAS||g/dL||Standard Deviation|Mean
859118|NCT01352221|Secondary|Change in Haemoglobin Concentration From Baseline to Week 48 (Full Analysis Set, FAS)|Change in Haemoglobin Concentration from Baseline to Week 48 (FAS), after 12-week double-blind phase and then 36 weeks of open-label ST10 treatment|Baseline to Week 48 - open-label phase|FAS||g/dL||Standard Deviation|Mean
859119|NCT01352221|Secondary|Change in Haemoglobin Concentration From Baseline to Week 36 (Full Analysis Set, FAS)|Change in Haemoglobin Concentration from Baseline to Week 36 (FAS), after 12-week double-blind phase and then 24 weeks of open-label ST10 treatment|Baseline to Week 36 - open-label phase|FAS||g/dL||Standard Deviation|Mean
859120|NCT01352221|Secondary|Change in Haemoglobin Concentration From Baseline to Week 24 (Full Analysis Set, FAS)|Change in Haemoglobin Concentration from Baseline to Week 24 (FAS), after 12-week double-blind phase and then 12 weeks of open-label ST10 treatment|Baseline to Week 24 - open-label phase|FAS||g/dL||Standard Deviation|Mean
859121|NCT01352221|Secondary|Change in Haemoglobin Concentration From Baseline to Week 20 (Full Analysis Set, FAS)|Change in Haemoglobin Concentration from Baseline to Week 20 (FAS), after 12-week double-blind phase and then 8 weeks of open-label ST10 treatment|Baseline to Week 20 - open-label phase|FAS||g/dL||Standard Deviation|Mean
859122|NCT01352221|Secondary|Change in Haemoglobin Concentration From Baseline to Week 16 (Full Analysis Set, FAS)|Change in Haemoglobin Concentration from Baseline to Week 16 (FAS), after 12-week double-blind phase and first 4 weeks of open-label ST10 treatment.|Baseline to Week 16 - open-label phase|FAS||g/dL||Standard Deviation|Mean
859123|NCT01352221|Secondary|Change in Hb Concentration From Baseline to Week 8 (Full Analysis Set, FAS)|ANCOVA analysis of Change in Hb concentration from Baseline to Week 8 of double-blind phase - FAS, multiple imputation|Baseline to Week 8 - double-blind phase|FAS||g/dL||Standard Deviation|Mean
859124|NCT01352221|Secondary|Change in Hb Concentration From Baseline to Week 4 (Full Analysis Set, FAS)|ANCOVA analysis of the change in Hb concentration from Baseline to Week 4 of the double-blind phase - Full Analysis Set, multiple imputation|Baseline to Week 4 - double-blind phase|||g/dL||Standard Deviation|Mean
859125|NCT01352221|Secondary|Proportion of Subjects That Achieved Hb Concentration Within Normal Range at Week 12 (Full Analysis Set, FAS)|Logistic regression analysis of proportion of subjects that achieved Hb concentration within normal range at Week 12 end of double-blind phase|Baseline to Week 12 - double-blind phase|FAS||Participants|||Count of Participants
859128|NCT01352221|Primary|Change in Haemoglobin (Hb) Concentration From Baseline to Week 12 (Full Analysis Set, FAS)|Primary efficacy endpoint, defined as the change in Hb concentration from Baseline to Week 12. Baseline was defined as the pre-dose Hb concentration measured at the Randomisation Visit (Week 0). Missing Randomisation Hb values were replaced by Screening Hb values, if the randomisation was within the protocol-specified window. Hb concentration (g/dL) was analysed by a central laboratory from blood samples collected at every clinic visit: Screening, Randomisation (Week 0), Weeks 4, 8, 12, 14, 16, 20, 24, 36, 48, 64, Weeks 14 to 64 were open-label. The baseline, absolute concentration and change from baseline in Hb at all post-randomisation visits were listed and summarised by week using descriptive statistics. An analysis of covariance (ANCOVA) was used to analyse the primary endpoint; this included treatment, gender and disease as factors and baseline Hb as a covariate.|Baseline to Week 12 - double-blind phase|Full Analysis Set (FAS)||g/dL||Standard Deviation|Mean
859129|NCT01320072|Secondary|Change in Forced Expiratory Volume in One Second (FEV1) in Aspirin Exacerbated Respiratory Disease (AERD) Patients|We will assess FEV1% change from baseline at 12 months in AERD patients who have been on aspirin treatment for 12 months (current standard of care)|12 months|AERD patients will continue aspirin treatment for 12 months and the change from baseline in their FEV1% predicted will be monitored during this time||change in percent predicted FEV1||Standard Error|Mean
859130|NCT01320072|Secondary|Treatment-Related Adverse Events|Adverse reactions defined as bronchospasm requiring endotracheal intubation. The adverse reactions will be assessed through a post challenge follow-up with the patient at baseline and 24 hours after the challenge|24 hours after the challenge|||participants|||Number
859131|NCT01320072|Primary|Eicosanoid Metabolites Concentration|eicosanoid metabolites concentration in plasma and urine 2 h post ASA challenge|2 hours|||log-pg/mg creatinine||Standard Error|Mean
859132|NCT01286012|Secondary|Iron Delivery to the Erythron as Estimated by Hemoglobin Generation in Response to Erythropoietin (ESA Response Index, or ERI, Calculated as ESA Dose/Hgb). The ERI Will Also be Divided by Body Weight in Kilograms to Obtain a Modified ERI (ERI/kg).||Hemoglobin measured weekly; ESA dose recorded at each visit for 36 weeks, pre-dialysis body weight recorded at each visit for the first four weeks of the study and then weekly for the rest of the study.||||||
859133|NCT01286012|Secondary|Markers of Inflammation and Oxidative Stress||measured pre and post-dialysis at Week 1 Visit 2 and pre-dialysis at Weeks 4, 12, 24, and 36 of the study.||||||
859134|NCT01286012|Secondary|The Amount of Supplemental Intravenous (IV) Iron Needed.||Recorded at every dialysis session for 36 weeks|||mg/week||Standard Deviation|Mean
859135|NCT01286012|Secondary|Stability of Hemoglobin Over Time (Maintenance of Hemoglobin Between 9.5-11.5 g/dL, and Variability in Hemoglobin [Hgb-var]).||measured weekly for 36 weeks.||||||
859136|NCT01286012|Secondary|"The Incidence of Patient Failures, Defined as ≥ 25% Increase From Baseline in ESA Dose Sustained Continuously for ≥ 8 Weeks."||ESA dose is monitored and recorded at each dialysis session for 36 weeks.||||||
859137|NCT01286012|Secondary|"The Incidence of Patient Responders Defined as ≥ 25% Decrease From Baseline in ESA Dose Sustained Continuously for ≥ 8 Weeks."||ESA dose is monitored and recorded at each dialysis session for 36 weeks.||||||
859138|NCT01286012|Primary|The Percent Change From Baseline in ESA Dose Required to Maintain Hemoglobin in the Target Range, Adjusted for Hgb.|The statistical endpoint is the change from baseline between groups at End of Treatment, where the baseline prescribed ESA dose (expressed as U/week epoetin) per subject is defined as the average weekly dose of ESA prescribed for administration over the two-week period of time immediately prior to randomization. The end-of-treatment prescribed ESA dose (expressed as U/week epoetin) per subject is defined as the average weekly dose of ESA prescribed for administration over the last two weeks of the treatment period.|Hemoglobin measured weekly and serum ferritin and Transferrin Saturation (TSAT) determined every other week; ESA dose recorded at each visit for 36 weeks.|MITT population: Randomized subjects who received at least one dose of study drug and also received ESA during the treatment period.||Percent change||Standard Error|Least Squares Mean
859139|NCT01141712|Secondary|Ig and Epstein-Barr Virus (EBV) DNA in Blood|The presence of clonal Ig DNA in plasma will be assessed, as will EBV copy number in plasma and in peripheral blood|Day 100, 180, and 365|No data collected to analyze this outcome measure.|||||
859140|NCT01141712|Secondary|Microbial Translocation Markers|Level of microbial translocation markers will be determined by nonparametric Mann-Whitney tests comparing the distribution of prior microbial translocation markers between patients.|Day 30 and 100|No data collected to analyze this outcome measure.|||||
859141|NCT01141712|Secondary|HIV Single-Copy Polymerase Chain Reaction (PCR)|HIV RNA assay will be performed at the specified time points and summarize the assessments of the viral copy number using descriptive statistics.|Baseline, Days 100, 180, 365, and 730|Participants with an undetectable (<50 copies/mL) viral load are not included in this analysis (Baseline = 32, Day 100 = 19, Day 180 = 20, Day 365 = 19, and Day 730 = 21)||copies/mL||Full Range|Median
859142|NCT01141712|Secondary|Immunologic Reconstitution|Immunologic Reconstitution will be assessed by quantitative immunoglobulin measurement (IgM, IgG and IgA)|Year 1|||mg/dL||Full Range|Median
859143|NCT01141712|Secondary|Treatment-Related Mortality (TRM)|TRM is defined as death occurring in a patient from causes other than relapse or progression. A cumulative incidence curve will be computed along with a 95% confidence interval at 100 days post-transplant.|Day 100|||percentage of participants||95% Confidence Interval|Number
859144|NCT01141712|Secondary|Number of Participants Experiencing Infections|Microbiologically documented infections will be reported by site of disease, date of onset, severity, and resolution, if any.|Year 1|||participants|||Number
859145|NCT01141712|Secondary|Number of Participants Experiencing Toxicity|Toxicities will be defined by using the version 3.0 NCI Common Terminology Criteria for Adverse Events (CTCAE) criteria. Only grade 3 and higher toxicities will be collected.|Year 2|||participants|||Number
859146|NCT01141712|Secondary|Hematologic Function|Hematologic function will be defined as ANC > 1500 neutrophils/μL, Hemoglobin> 10g/dL without transfusion support, and platelets > 100,000/μL|Days 100 and 365|||participants|||Number
859147|NCT01141712|Secondary|Cumulative Incidence of Platelet Recovery|Platelet recovery is defined as a platelet count greater than 20,000/μL for the first of two consecutive labs with no platelet transfusions 7 days prior.|Day 100|||percentage of participants||95% Confidence Interval|Number
859173|NCT01002742|Secondary|Incidence of Chronic GVHD||12 months post-randomization|||percentage of participants||95% Confidence Interval|Number
859151|NCT01141712|Secondary|Complete Remission (CR) and/or Partial Response (PR)|The frequencies and proportions of patients who have a CR or PR. CR is defined as the disappearance of all evidence of disease, and PR is defined as the regression of measurable disease and no new sites.|Day 100|One participant died at day 64 and was not included in analysis||participants|||Number
859152|NCT01141712|Secondary|Progression-Free Survival (PFS)|The time to this event is the time from enrollment until death, relapse/progression, receipt of anti-lymphoma therapy, or last follow up, whichever comes first. Progression-free survival (PFS) will be estimated using the Kaplan Meier product limit estimator. The PFS probability and confidence interval will be calculated at two years post-transplant.|Year 2|||percentage of participants||95% Confidence Interval|Number
859153|NCT01141712|Secondary|Relapse/Progression|Relapse is defined as the appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size. Progression is defined as a lymph node with a diameter of the short axis of less than 1.0 cm must increase by >= 50% and to a size of 1.5 x 1.5 cm or more than 1.5 cm in the long axis.|Year 2|||percentage of participants||95% Confidence Interval|Number
859154|NCT01141712|Primary|Overall Survival (OS)|Assess the OS after autologous hematopoietic stem cell transplantation (HCT) for chemotherapy-sensitive aggressive B cell lymphoma or Hodgkin's lymphoma in patients with HIV using BEAM for pre-transplant conditioning. The primary analysis will consist of estimating the 1 year OS probability from the time of transplantation based on the Kaplan-Meier product limit estimator. The 1 year and 2 year OS and confidence interval will be calculated.|Year 1 and 2|||percentage of participants||95% Confidence Interval|Number
859155|NCT01120782|Primary|Prescription Equivalence|Number of subjects whose prescription is the same for the two lenses tested.|after 15 minutes of lens wear|All completed subjects.||participants|||Number
859156|NCT01111305|Secondary|Proportion of Subjects Who Clear Blood Microfilariae||3, 7, and 28 days after initiation of treatment with DEC|||Participants|||Count of Participants
859157|NCT01111305|Secondary|Markers of Eosinophil Activation Including Levels of Eosinophil Surface Marker Expression and Serum Levels of Eosinophil Granule Proteins||through study completion||12/2017||||
859158|NCT01111305|Secondary|Frequency of AE's|Adverse events during the first week of DEC treatment|7 days following initiation of DEC treatment|Subjects who received DEC treatment||adverse events|||Number
859159|NCT01111305|Primary|Change in Peak Eosinophil Count Measure as a Percent of Baseline Count.|Peak absolute eosinophil count during the week following DEC treatment as a percent of baseline eosinophil count|during the first 7 days of DEC treatment|Subjects who received diethylcarbamazine treatment||percentage of baseline||Full Range|Geometric Mean
859160|NCT01042535|Other Pre-specified|Phase 2 - Change in Biomarker Level|Biomarkers include serum kynurenine, serum tryptophan, C reactive protein, and circulating T-regulatory cell levels (CD4+ 25+ CD127low forkhead box protein 3+ (FoxP3+). Appropriate t-tests and/or Wilcoxon test will be employed to study changes over time.|Baseline to week 16||||||
859161|NCT01042535|Secondary|Phase 2 – Median Progression Free Survival (PFS) in Weeks|Progressive Disease (PD): Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. PFS: Time from study entry to documentation of radiologic progressive disease or death, assessed up to 3 years.|Up to 3 years|All evaluable participants at time of analysis||weeks||Full Range|Median
859162|NCT01042535|Secondary|Phase 2 – Number of Participants With Clinical Benefit From Chemotherapy After Vaccination|Clinical response rate evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the diameter (LD) of target lesions, taking as reference the baseline sum LD. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Up to 3 years|All evaluable participants at time of analysis||participants|||Number
859163|NCT01042535|Secondary|Phase 1 - Number of Participants With Objective Response at 6 Weeks|Immunologic Response defined as Interferon-γ (IFN-γ) p53 T cell specific enzyme-linked immunospot (ELISPOT) assay count Summarized using both point estimates and the 95% exact confidence intervals based on the binomial distribution. Briefly, 2x10^5 mononuclear cells obtained from the peripheral blood of patients will be plated in quadruplicates in 96-well multiscreen mixed cellulose ester (HA) filtration plates, processed and incubated, spots will be visualized. The number of spots will be calculated per 10^6 cells. Untreated peripheral blood mononuclear cells (PBMNC) will represent a negative control and PBMNC stimulated with 10 µg/ml Concanavalin A (ConA) – positive control.|At 6 weeks|Phase I Participants who Received at Least 1 Dose of Ad.p53DC+indoximod||participants|||Number
859164|NCT01042535|Primary|Phase 2 – Number of Participants With Stable Disease In Response to Study Therapy|Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Up to 16 weeks|All evaluable participants at time of analysis||participants|||Number
859165|NCT01042535|Primary|Phase 1 - Maximum Tolerated Dose (MTD) in Milligrams (mg)|MTD of 1-methyl-d-tryptophan (indoximod) given by mouth (PO), twice a day (BID), with up to 6 fixed doses Ad.p53 DC vaccinations every 2 weeks (q2wks). This phase 1 study used a 3+3 design with 7 indoximod dose levels (DL) (100 mg, 200 mg, 400 mg, 800 mg daily (QD) then 800 mg, 1,200 mg, and 1,600 mg PO BID +up to 6 fixed dose Ad.p53 DC vaccinations q2wks. Toxicity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0. The MTD is the highest dose level below the maximally administered dose (MAD) that is safely tolerated among 6 treated patients, that is, 0 or 1 out of 6 patients experiences a dose limiting toxicity (DLT).|Up to 4 weeks|Phase I Participants who Received at Least 1 Dose of Ad.p53DC+indoximod||indoximod dose in mg|||Number
859166|NCT01002742|Secondary|Change in Patient Reported Outcomes From Enrollment to Day 56||Day 56|No data collected|||||
859167|NCT01002742|Secondary|Treatment Related Mortality (TRM)||Year 1|||percentage of participants||95% Confidence Interval|Number
859168|NCT01002742|Secondary|Disease-Free Survival (DFS) Post-Randomization|DFS includes death or progression/relapse of malignancy|Year 1|||percentage of participants||95% Confidence Interval|Number
859169|NCT01002742|Secondary|Cumulative Incidence of a Severe/Life-threatening/Fatal Infections||Year 1|||percentage of participants||95% Confidence Interval|Number
859170|NCT01002742|Secondary|Incidence of Cytomegalovirus (CMV) Reactivation||Year 1|||percentage of participants|||Number
859197|NCT00910962|Secondary|Mean Left Ventricular End-diastolic Volume (LVEDV) and Left Ventricular End-systolic Volume (LVESV) at Week 12|Statistical analyses of the treatment differences was performed to compare the LVEDV and LVESV (via MRI) at Week 12, and for the change from Day 3 to Week 12 via repeated measures ANCOVA between study drug and placebo. Cardiac MRIs were performed at qualified sites on participants who agree to participate in the MRI sub-study. A total of 15 participants out of 93 MRI ITT participants were excluded from the analysis due to missing Baseline cTnI (10 participants) and onset chest pain duration (9 participants). Four participants had both covariate values missing.|At Week 12|MRI ITT Population. Only those participants with data available at the indicated time points were analyzed.||mL||Standard Deviation|Mean
859198|NCT00910962|Secondary|Mean Percent Left Ventricular Ejection Fraction (LVEF) at Week 12|Statistical analyses of the treatment differences was performed to compare the LVEF (via MRI) at Week 12, and for the change from Day 3 to Week 12 via repeated measures ANCOVA between study drug and placebo. Cardiac MRIs were performed at qualified sites on participants who agree to participate in the MRI sub-study. A total of 15 participants out of 93 MRI ITT participants were excluded from the analysis due to missing Baseline cTnI (10 participants) and onset chest pain duration (9 participants). Four participants had both covariate values missing.|At Week 12|MRI ITT Population. Only those participants with data available at the indicated time points were analyzed.||Percent||Standard Deviation|Mean
859199|NCT00910962|Secondary|Mean Infarct Size Prior to Discharge From Hospital (Approximately Day 3) and at Week 12|Statistical analyses was performed to compare the infarct size (via MRI) at Week 12 via repeated measures ANOVA between study drug and placebo using Bayesian methods for inference. Myocardial infarct size was measured by delayed enhancement magnetic resonance imaging (MRI) as: Infarct size (% of left ventricular myocardium [% of LV]) for infarct 1. The infarct region 1 was the infarct region which the MRI interpretation process identified as the primary infarct region of the index hospitalization. Participants were included in the analyses, provided they have data for derivation of the measures of interest (MR infarct size). A total of 15 participants out of 93 MRI ITT participants were excluded from the analysis due to missing Baseline cTnI (10 participants) and onset chest pain duration (9 participants). Four participants had both covariate values missing.|Prior to discharge (visit 1) and at Week 12|MRI ITT Population was subset of participants in the ITT Population who had at least one MRI scan. Only those participants available at the specified time points were analyzed.||Percent of left ventricle||Standard Deviation|Mean
859200|NCT00910962|Secondary|Mean Brain Natriuretic Peptide (BNP) at Discharge and Week 12|Statistical analyses was performed to compare BNP levels between study drug and placebo. Log transformed ratio to Baseline BNP was analyzed using repeated measures ANCOVA including a term for treatment, adjusting for Baseline BNP as a covariate, and accounting for other covariates as appropriate to the study design.|At discharge and Week 12|ITT Population. Only those participants available at the specified time points were analyzed.||pg/mL||Geometric Coefficient of Variation|Geometric Mean
859201|NCT00910962|Secondary|Peak cTnI Over 72 Hours Post-randomization or Until Hospital Discharge (Whichever Comes First)|Statistical analyses was performed to compare cTnI levels between study drug and placebo. Log transformed ratio to Baseline cTnI was analyzed using repeated measures ANCOVA including a term for treatment, adjusting for Baseline cTnI as a covariate, and accounting for other covariates as appropriate to the study design.|Up to 72 hours|ITT Population. Only those participants with data available at the indicated time points were analyzed.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
859202|NCT00910962|Secondary|Mean Creatine Kinase (MB Isoenzyme) (CK-MB) AUC Over 72 Hours Post-randomization or Until Hospital Discharge (Whichever Comes First)|Statistical analyses was performed to compare CK-MB levels between study drug and placebo. Log transformed ratio to Baseline CK-MB was analyzed using repeated measures ANCOVA including a term for treatment, adjusting for Baseline CK-MB as a covariate, and accounting for other covariates as appropriate to the study design.|At pre-dose and at hours 8, 16, 24, 32, 40, 48, 56, 64 and 72|ITT Population. Only those participants available at the specified time points were analyzed.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
859203|NCT00910962|Secondary|Mean Interleukin-6 (IL-6) Value at 24 Hours Post-randomization and at Weeks 2 and 12|Statistical analyses was performed to compare IL-6 levels between study drug and placebo. Log transformed ratio to Baseline IL-6 was analyzed using repeated measures ANCOVA including a term for treatment, adjusting for Baseline IL-6 as a covariate, and accounting for other covariates as appropriate to the study design.|24 hours post-randomization and at Weeks 2 and 12|ITT Population. Only those participants available at the specified time points were analyzed.||picograms per milliliter (pg/mL)||Geometric Coefficient of Variation|Geometric Mean
859204|NCT00910962|Secondary|Mean hsCRP Over Hospitalization Period and Through Week 14|Analysis of hsCRP included all participants who provided data at Baseline and at least one post-Baseline measure. The sample had a collection window of +/- 8 hours. Statistical analyses was performed to compare hsCRP levels between study drug and placebo. Log transformed ratio to Baseline hsCRP was analyzed using ANCOVA including a term for treatment, adjusting for Baseline hsCRP as a covariate, and accounting for other covariates as appropriate to the study design.|Up to Week 14|ITT Population. Only those participants available at the specified time points were analyzed.||mg/L||Geometric Coefficient of Variation|Geometric Mean
859205|NCT00910962|Primary|Mean Cardiac Troponin I (cTnI) Area Under Concentration-time Curve (AUC) Over 72 Hours Post-randomization or Until Hospital Discharge (Whichever Comes First)|cTnI AUC was the average concentration of cTnI during hospital stay. Statistical analyses was performed to compare cTnI levels between study drug and placebo, via ANCOVA.|At pre-dose and at 8, 16, 24, 32, 40, 48, 56, 64 and 72 hours|ITT Population. Only those participants available at 72 hours were analyzed.||nonograms*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
859206|NCT00910962|Primary|Mean High-sensitive C-Reactive Protein (hsCRP) Value at Week 12|Analysis of hsCRP included all participants who provided data at Baseline and at least one post-Baseline measure. Statistical analyses was performed to compare hsCRP levels between study drug and placebo. Log transformed ratio to Baseline hsCRP was analyzed using repeated measures analysis of covariance (ANCOVA) including a term for treatment, adjusting for Baseline hsCRP as a covariate, and accounting for other covariates as appropriate to the study design.|At Week 12|Intent-to-treat (ITT) Population comprised all randomized participants who received at least one dose of study medication and at least one on treatment assessment. Only those participants with data available at Week 12 were analyzed.||mg per liter (mg/L)||Geometric Coefficient of Variation|Geometric Mean
859207|NCT00910962|Primary|Number of Participants With Vital Signs of PCI at Any Visit Post-Baseline|Vital signs (PCI range): Systolic blood pressure (SBP) (<75 and >200 millimeter of mercury [mmHg]), Diastolic blood pressure (DBP) (<40 and >120 mmHg) and Heart rate (<30 and >200 beats per minute [bpm]) were analyzed and were presented at any visit post-Baseline. Participants with both Normal and Low values were counted once under their worst case (Low). Participants with both Normal and High values were counted once under their worst case (High). Participants with both High and Low values were counted under both categories. All heart rate values were within normal range, hence not presented.|Up to Week 14|Safety Population. Number of participants with analyzable samples at the time of analysis were included.||Participants|||Count of Participants
859208|NCT00910962|Primary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings at Any Time Post-Baseline|A single 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QT corrected (QTc) intervals. ECG findings were presented as Normal, Abnormal - Not clinically significant and Abnormal – Clinically significant at any time post-Baseline.|Up to Week 14|Safety Population. Only those participants with data available at the indicated time points were analyzed.||Participants|||Count of Participants
859209|NCT00910962|Primary|Number of Participants With Liver Function Test Elevations at Any Time Post-Baseline|Liver function test parameters: Alanine aminotransferase (ALT), Total Bilirubin (T. Bilirubin), Aspartate aminotransferase (AST), Alkaline Phosphatase, Gamma glutamyl transferase (GGT) and Creatine Kinase were analyzed and presented as elevated test values at any time post-Baseline. The elevations were presented as >=2xULN, >=3xULN, >=5xULN, >=10xULN, and >=20xULN. n= number of participants with at least one non-missing result of the particular lab test post-Baseline.|Up to Week 14|Safety Population. Number of participants with analyzable samples at the time of analysis were included.||Participants|||Count of Participants
859210|NCT00910962|Primary|Number of Participants With Clinical Chemistry Data of PCI at Any Visit Post-Baseline|Clinical chemistry parameters (PCI range): Alanine Amino Transferase (ALT) (>=3x upper limit normal [ULN] units per liter [U/L]), Albumin (<25.6 or >60 g/L), Alkaline Phosphatase (>=2x ULN U/L), Aspartate Amino Transferase (AST) (>=3x ULN U/L), Calcium (<2.0776 or >2.6112 millimoles per liter [mmol/L]), Carbon dioxide content/Bicarbonate (CO2/HCO3) (<19.6 or >32.64 mmol/L), Chloride (<93.1 or >110.16 mmol/L), Creatinine (<39.6 or >136.4 micromole per liter [µmol/L]) , Glucose (<3.51 or >6.05 mmol/L), Potassium (<3.43 or >5.406 mmol/L), Sodium (<132.3 or >148.92 mmol/L), Total Bilirubin (T. bilirubin) (>=1.5xULN µmol/L) , Total Protein (<50 or >95 g/L), Urea/Blood urea nitrogen (BUN) (<2.25 or >11.55 mmol/L) and Uric acid (<135 or >495 µmol/L) were analyzed. The data was presented as High and low, at any visit post-Baseline. Only parameters with observed abnormal values were presented.|Up to Week 14|Safety Population. Number of participants with analyzable samples at the time of analysis were included.||Participants|||Count of Participants
859211|NCT00910962|Primary|Number of Participants With Hematology Data of Potential Clinical Importance (PCI) at Any Visit Post-Baseline|Hematology parameters (PCI range): Eosinophils (<0.045 or >0.605 Giga cells per liter [GI/L]), Hematocrit (<0.297 or >0.506 ratio), Hemoglobin (<85 or >200 grams per liter [g/L]), Lymphocytes (<0.765 or >4.51GI/L), Mean Corpuscle Hemoglobin (MCH) (<24.3 or >38.5 picograms [PG]), Mean Corpuscle Hemoglobin Concentration (MCHC) (<256 or >432 g/L), Mean Corpuscle Volume (MCV) (<70 or >115 femtoliter [FL]), Monocytes (<0.18 or >1.21 GI/L), Platelet count (<104 or >480 GI/L), Red Cell Distribution Width (RDW) (<7.2 or >18%), Red Blood Cell (RBC) count (<2.88 or >6.12 trillion per liter [TI/L] for females and <3.52 or >6.96 TI/L for males) , Reticulocytes (<22.5 or >93.5 10^9/L), Total Absolute Neutrophil Count (ANC) (<1.62 or >8.8 GI/L), White Blood Cell (WBC) count (<3.04 or >12 GI/L) were analyzed. The data was presented as High and low, at any visit post-Baseline. Only parameters with observed abnormal values were presented.|Up to Week 14|Safety Population. Number of participants with analyzable samples at the time of analysis were included.||Participants|||Count of Participants
859212|NCT00910962|Primary|Number of Participants With Any Pure MACE|Pure MACE was defined as all-cause death, adjudicated myocardial infarction or stroke/transient ischemic attack.|Up to Week 14|Safety Population.||Participants|||Count of Participants
859213|NCT00910962|Primary|Number of Participants With Any Major Adverse Cardiovascular Events (MACE)|MACE was defined as all-cause death, adjudicated myocardial infarction, stroke/transient ischemic attack, heart failure or recurrent ischemia requiring urgent revascularization.|Up to Week 14|Safety Population||Participants|||Count of Participants
859214|NCT00910962|Primary|Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE was any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE was any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment.|Up to Week 14|Safety Population consisted of all participants randomized to treatment, who had taken at least one dose of study medication.||Participants|||Count of Participants
859215|NCT00908388|Primary|Exclusion of Primary Entry Tear|Number of subjects with successful coverage of Primary Entry Tear as assessed by the Core Lab using contrast-enhanced CT imagery|1 month|||participants|||Number
859216|NCT00908388|Secondary|Additional Dissection Based Intervention Rate|Number of participants that required additional dissection-based interventions defined as interventions related to malperfusion, rupture, or both, as adjudicated by CEC or Sponsor. Additional dissection based interventions included: peripheral stenting, fenestration, implantation of additional endovascular stent-grafts or other surgeries.|Last available follow-up through 5 years|||participants|||Number
859217|NCT00908388|Secondary|Aortic Rupture|Number of participants with thoracic aortic rupture|Last available follow-up through 5 years|||participants|||Number
859218|NCT00908388|Secondary|False Lumen Thrombosis|Number of participants with partial or complete False Lumen Thrombosis in the region of the aorta covered by the Conformable TAG device.|Last available follow-up through 5 years|Participants with contrast-enhanced CT imagery performed during the specified follow-up period were included in this analysis||participants|||Number
859219|NCT00908388|Primary|All-cause Mortality Incidence Through 30 Days Post-treatment||30 Days Post-Treatment|All subjects were analyzed. One subject whose vital status could not be confirmed was included as a death in this analysis.||participants|||Number
859220|NCT00864227|Secondary|Platelet Recovery to 50K|Platelet recovery is defined as the first day of a minimum of three consecutive measurements on different days such that the patient has achieved a platelet count >50,000/mm3 with no platelet transfusions in the preceding seven days.|Measured at Days 56, 90, and 100|||percentage of participants||95% Confidence Interval|Number
859221|NCT00864227|Secondary|Incidence of Infections|Number of participants that experienced at least one infection.|Measured at Year 1|||Infections|||Number
859222|NCT00864227|Secondary|Treatment-related Mortality (TRM)||Measured at 6 months and 1 year|||percentage of participants||95% Confidence Interval|Number
859223|NCT00864227|Secondary|Progression-free Survival|Progression-free survival is defined as the minimum time interval to relapse/ recurrence/progression, to death or to last follow-up.|Measured at Year 1|||percentage of participants||95% Confidence Interval|Number
859224|NCT00864227|Secondary|Chronic GVHD||Measured at Year 1|||percentage of participants||95% Confidence Interval|Number
859225|NCT00864227|Secondary|Acute Graft-versus-host Disease (GVHD)||Measured at Day 100|||percentage of participants||95% Confidence Interval|Number
859226|NCT00864227|Secondary|Donor Cell Engraftment|Marrow or Blood Sample. Donor cell engraftment is defined as donor chimerism ≥ 5% on Day ≥ 56 after transplantation. Chimerism should be evaluated on Days ~28, ~56, ~180, and ~365 after transplantation. Chimerism may be evaluated in whole blood or mononuclear fraction.|Measured at Day 56|||participants|||Number
859227|NCT00864227|Secondary|Platelet Recovery to 20K|Platelet recovery is defined as the first day of a minimum of three consecutive measurements on different days such that the patient has achieved a platelet count >20,000/mm3 with no platelet transfusions in the preceding seven days.|Measured at Days 56, 90, and 100|||percentage of participants||95% Confidence Interval|Number
859228|NCT00864227|Secondary|Secondary Graft Failure|Secondary graft failure is defined initial recovery followed by neutropenia with < 5% donor chimerism.|Measured at Day 100|||participants|||Number
859229|NCT00864227|Secondary|Primary Graft Failure|Primary graft failure is defined as < 5% donor chimerism on all measurements prior to and day-100.|Measured at Day 100|||participants|||Number
859230|NCT00864227|Secondary|Neutrophil Recovery|Neutrophil recovery is defined as achieving an absolute neutrophil count ≥ 500/mm3 for three consecutive measurements on different days.|Measured at Days 28, 56, 90, and 100|||percentage of participants||95% Confidence Interval|Number
859231|NCT00864227|Primary|Overall Survival at 180 Days From the Time of Transplant||Measured at Month 6 and Year 1|||percentage of participants||95% Confidence Interval|Number
859232|NCT00859040|Secondary|Overall Survival|Percentage of participants alive 34 months after initiating study treatment. Median Overall Survival has not yet been reached for one study group; therefore, we are reporting Overall Survival rates by the end of the study time frame.|34 months|||percentage of participants|||Number
859233|NCT00859040|Secondary|Median Time to Progression|Per protocol, the study’s secondary objectives are to be evaluated “for the estimate of median ... PFS ... at time of interest.” At this time, all study participants have been followed for progression for a minimum of 34 months (final patient to accrue to study was registered to trial on 06/14/2011), and study manuscript is currently being written-up with this information.|34 months|"Time to progression only reported for the 32 patients who have progressed (either on treatment or in follow-up).
[NOTE: The other 2 patients who were treated on study each remain progression-free after > 1000 days.]"||days||Full Range|Median
859234|NCT00859040|Secondary|Median Progression-Free Survival||5 years|||weeks||95% Confidence Interval|Median
859235|NCT00859040|Secondary|Treatment-related Events|All Grade 3-4-5 adverse events with a treatment attribution of probable, possible or definite based on CTCAE (v3.0) as reported on case report forms|5 years|||events|||Number
859236|NCT00859040|Secondary|Response Rate|"Number of participants to experience complete or partial response on study treatment.
For response per Modified Macdonald Criteria, all measurable and evaluable lesions and sites must be assessed using the same techniques as baseline.
Complete Response (CR): Complete disappearance of all measurable and evaluable disease. No new lesions. No evidence of non-evaluable disease. Patients must be on no steroids.
Partial Response (PR): Greater than or equal to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions. The steroid dose at the time of the scan evaluation should be no greater than the maximum dose used in the first 8 weeks from initiation of therapy."|5 years|||participants|||Number
859237|NCT00859040|Primary|6 Month Progression Free Survival|Progression is defined using Modified Macdonald Criteria , using a >/= 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR clear clinical worsening or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).|6 months|||percentage of patients|||Number
859238|NCT00694551|Secondary|Number of Participants Who Did Not Have PSA Doubling|Number of participants who did not have a PSA doubling before their last study visit, median 458 days from baseline PSA (55-613).|Up to 48 months|29 patients who had serial PSA data, normalized by date and PSA.||participants|||Number
859239|NCT00694551|Secondary|Number of Participants With Prostatic Specific Antigen (PSA) Doubling|"Number of Participants Who Had a Doubling of the PSA or Proceeded to Another Therapy.
Assess the impact of the vaccine on the pattern of PSA change in patients with castrate testosterone level and in patients with non-suppressed testosterone level not on hormone therapy."|Up to 48 months|29 patients who had serial PSA data, normalized by date and PSA.||participants|||Number
859240|NCT00694551|Primary|Occurrence of Related Adverse Events - Grade 3 or Higher|Number of participants with related Grade 3 or higher adverse events. Establish the safety and toxicity of varying doses of polypeptide vaccines PSMA and TARP administered with a fixed dose of Poly IC-LC as an adjuvant.|Up to 48 months|All participants who received treatment.||participants|||Number
859241|NCT00678301|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/ incapacity.|Throughout the entire study period, from Month 0 to Month 3|The Total Vaccinated Cohort included all evaluable subjects.||Participants|||Count of Participants
859242|NCT00678301|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. “Any” was defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.|Within the 31-day (Days 0-30) follow-up periods post vaccination, across doses and across vaccines|The Total Vaccinated Cohort included all evaluable subjects.||Participants|||Count of Participants
859243|NCT00678301|Secondary|Number of Subjects With Fever (Temperature Measured Rectally) > the Cut-off|The cut-off for the assay was > 39.0°C.|Within the 4-day (Days 0 to 3) follow-up periods after each vaccination, across doses and across vaccines|The Total Vaccinated Cohort included all evaluable subjects.||Participants|||Count of Participants
859244|NCT00678301|Secondary|Number of Subjects With Any and Any Grade 3 and Related Solicited General Symptoms|Solicited general symptoms assessed include drowsiness, fever (defined as rectal temperature ≥ 38.0°C), irritability, and loss of appetite. “Any” was defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectal temperature) greater than (>) 40.0 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/ preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all.|Within the 4-day (Days 0 to 3) follow-up periods after each vaccination, across doses and across vaccines|The Total Vaccinated Cohort included all evaluable subjects.||Participants|||Count of Participants
859245|NCT00678301|Secondary|Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed included pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/ spontaneously painful. Grade 3 swelling/ redness was defined as swelling/ redness greater than (>) 30 millimeters (mm). “Any” was defined as incidence of the specified symptom regardless of intensity.|Within the 4-day (Days 0 to 3) follow-up periods after each vaccination, across doses and across vaccines|The Total Vaccinated Cohort included all evaluable subjects.||Participants|||Count of Participants
859246|NCT00678301|Secondary|Number of Subjects Seroprotected as Regards Anti-Hepatitis B Surface Antigen (HBs) Antibodies.|The seroprotection cut-off values considered for this endpoint were an anti-HBs antibody concentration ≥ 10 and 100 milli-international units per millliter (mIU/mL).|At Month 3, one month after the administration of the third dose of Tritanrix HepB/ Hiberix vaccine|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Participants|||Count of Participants
859247|NCT00678301|Secondary|Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations|The seroprotection cut-off for the endpoint was an anti-HBs antibody concentration ≥ 10 milli-international units per millliter (mIU/mL).|At Month 3, one month after the administration of the third dose of Tritanrix -HepB /Hiberix vaccine|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||mIU/mL||95% Confidence Interval|Geometric Mean
859248|NCT00678301|Secondary|Number of Subjects Seroprotected as Regards Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibodies ≥ the Cut-off|Anti-PRP antibody concentrations were expressed in microgram per milliliter (μg/mL). The seroprotection cut-off applied for the assay was ≥ 1 μg/mL.|At Month 3, one month after the administration of the third dose of Tritanrix -HepB/ Hiberix vaccine|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Participants|||Count of Participants
859249|NCT00678301|Secondary|Number of Subjects Seroprotected as Regards Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibodies ≥ the Cut-off.|Anti-PRP antibody concentrations were expressed in microgram per milliliter (μg/mL). The seroprotection cut-off applied for the assay was ≥ 0.15 μg/mL.|At Month 3, one month after the administration of the third dose of Tritanrix -HepB/ Hiberix vaccine|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Participants|||Count of Participants
859250|NCT00678301|Secondary|Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations|Anti-PRP antibody concentrations were measured and tabulated in microgram per milliliter (μg/mL). Cut-off for the assay was ≥ 0.15 μg/mL.|At Month 3, one month after the administration of the third dose of Tritanrix -HepB/ Hiberix vaccine|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||μg/mL||95% Confidence Interval|Geometric Mean
859251|NCT00678301|Secondary|Number of Subjects Seroprotected as Regards Anti-diphtheria (Anti D) and Anti-tetanus Toxoids (Anti TT) Antibodies|A seroprotected subject as regards anti-D/-TT antibodies was defined as a subject with an Anti-D/-TT antibody concentration ≥ 0.1 IU/mL.|At Month 3, one month after the administration of the third dose of Tritanrix -HepB/ Hiberix vaccine|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Participants|||Count of Participants
859252|NCT00678301|Secondary|Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations|The seroprotection cut-off for the assay was an anti-diphtheria toxoid or anti-tetanus toxoid antibody concentrations ≥ 0.1 international unit per millliter (IU/mL).|At Month 3, one month after the administration of the third dose of Tritanrix -HepB/ Hiberix vaccine|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||IU/mL||95% Confidence Interval|Geometric Mean
859253|NCT00678301|Secondary|Number of Subjects Seropositive as Regards Anti-Bordetella Pertussis (Anti-BPT) Antibodies|Seropositivity cut-off for the assay was defined as an anti-BPT antibody concentration ≥ 15 enzyme-linked immunosorbent assay (ELISA) unit per milliliter (EL.U/mL).|At Month 3, one month after the administration of the third dose of DTPw-HBV/Hib vaccine|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Participants|||Count of Participants
859254|NCT00678301|Secondary|Anti-Bordetella Pertussis (Anti-BPT) Antibody Concentrations|Anti-BPT antibody concentrations were expressed in enzyme-linked immunosorbent assay (ELISA) unit per millilitre (EL.U/mL). Seropositivity cut-off for the assay was defined as an anti-BPT antibody concentrations ≥ 15 EL.U/mL|At Month 3, one month after the administration of the third dose of Synflorix vaccine|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||EL.U/mL||95% Confidence Interval|Geometric Mean
859255|NCT00678301|Secondary|Number of Subjects Seropositive as Regards Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes|Pneumococcal serotypes assessed were cross-reactive pneumococcal serotypes 6A and 19A. Seropositivity status was defined as an opsonophagocytic activity against cross-reactive pneumococcal serotypes 6A and 19A (OPA-6A and 19A) ≥ 8.|At Month 3, one month after the administration of the third dose of Synflorix vaccine|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Participants|||Count of Participants
859256|NCT00678301|Secondary|Number of Subjects Seropositive as Regards Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes|Pneumococcal serotypes assessed were vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Seropositivity status was defined as an opsonophagocytic activity against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (OPA-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 8.|At Month 3, one month after the administration of the third dose of Synflorix vaccine|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Participants|||Count of Participants
859257|NCT00678301|Secondary|Number of Subjects Seropositive as Regards Antibodies Against Protein D (Anti-PD Antibodies)|Seropositivity cut-off for the assay was an anti-PD antibody concentrations ≥ 100 EL.U/mL.|At Month 3, one month after the administration of the third dose of Synflorix vaccine|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Participants|||Count of Participants
859258|NCT00678301|Secondary|Number of Subjects Seroprotected as Regards Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and -19A)|Serotypes assessed were cross-reactive pneumococcal serotypes 6A and 19 A. Seroprotection cut-off for the assay was an anti-6A/19A antibody concentrations ≥ 0.2 microgram per milliliter (μg/mL).|At Month 3, one month after the administration of the third dose of Synflorix vaccine|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Participants|||Count of Participants
859259|NCT00678301|Secondary|Number of Subjects Seropositive as Regards Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and -19A)|Serotypes assessed were cross-reactive pneumococcal serotypes 6A and 19A. Seropositivity status was defined as anti-pneumococcal cross-reactive serotypes 6A/19A antibody concentrations (Anti-6A/19A) ≥ 0.05 microgram per milliliter (μg/mL).|At Month 3, one month after the administration of the third dose of Synflorix vaccine|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Participants|||Count of Participants
859260|NCT00678301|Secondary|Number of Subjects Seroprotected as Regards Antibodies Against Vaccine Pneumococcal Serotypes|Pneumococcal serotypes assessed were vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Seroprotection cut-off for the assay was an anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) concentrations ≥ 0.2 microgram per milliliter (μg/mL).|At Month 3, one month after the administration of the third dose of Synflorix vaccine|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Participants|||Count of Participants
859261|NCT00678301|Secondary|Number of Subjects Seropositive for Antibodies Against Vaccine Pneumococcal Serotypes|Pneumococcal serotypes assessed were vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Seropositivity cut-off for the assay was an anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) concentrations ≥ 0.05 microgram per milliliter (μg/mL).|At Month 3, one month after the administration of the third dose of Synflorix vaccine|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Participants|||Count of Participants
859262|NCT00678301|Secondary|Titers for Opsonophagocytic Activity (OPA) Against Cross-reactive Pneumococcal Serotypes|Pneumococcal serotypes assessed were cross-reactive pneumococcal serotypes 6A and 19A. Seropositivity status was defined as an opsonophagocytic activity against cross-reactive pneumococcal serotypes 6A and 19A (OPA-6A and 19A) ≥ 8.|At Month 3, one month after the administration of the third dose of Synflorix vaccine|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Titres||95% Confidence Interval|Geometric Mean
859263|NCT00678301|Secondary|Titers for Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes|Pneumococcal serotypes assessed were vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Seropositivity status was defined as an opsonophagocytic activity against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (OPA-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 8.|At Month 3, one month after the administration of the third dose of Synflorix vaccine|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Titers||95% Confidence Interval|Geometric Mean
859264|NCT00678301|Secondary|Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and -19A)|Seropositivity status was defined as anti-pneumococcal cross-reactive serotypes 6A/19A antibody concentrations (Anti-6A/19A) ≥ 0.05 microgram per milliliter (μg/mL).|At Month 3, one month after the administration of the third dose of Synflorix vaccine|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||μg/mL||95% Confidence Interval|Geometric Mean
859265|NCT00678301|Primary|Antibody Concentrations Against Protein D (Anti-PD Antibodies)|Anti-PD antibody concentrations were expressed in enzyme-linked immunorbent assay (ELISA) units per milliliter (EL.U/mL). Seropositivity cut-off for the assay was an anti-PD antibody concentrations ≥ 100 EL.U/mL.|At Month 3, one month after the administration of the third dose of Synflorix vaccine|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||EL.U/mL||95% Confidence Interval|Geometric Mean
859266|NCT00678301|Primary|Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes|Pneumococcal serotypes assessed were vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Seropositivity cut-off for the assay was an anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) concentrations greater than or equal to (≥) 0.05 microgram per milliliter (μg/mL).|At Month 3, one month after the administration of the third dose of Synflorix vaccine|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||μg/mL||95% Confidence Interval|Geometric Mean
859267|NCT00581308|Secondary|Secondary Outcome: Days in Hospital for Procedure||Post Procedure|||Days||Full Range|Median
859268|NCT00581308|Secondary|Days in Hospital for Procedure||Post Procedure|||Days||Standard Deviation|Mean
859269|NCT00581308|Secondary|Secondary Outcome: Total Time Under Fluoroscopy||Procedure|||minutes||Full Range|Median
859270|NCT00581308|Secondary|Total Time Under Fluoroscopy||Procedure|||minutes||Standard Deviation|Mean
859271|NCT00581308|Secondary|Secondary Analyses Will be Performed on All Patients Enrolled With a Device Implanted, Regardless of Meeting Inclusion / Exclusion Criteria or Anatomic Suitability Criteria, Using Data From All Visit Evaluations.||1 year postprocedure||||||
859272|NCT00581308|Primary|Clinical Success Endpoint||12 months|Subjects with Successful Device Delivery||Participants|||Number
859273|NCT00554515|Post-Hoc|Objective Response Rate (Investigator Assessment)|The objective response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) on treatment based on World Health Organization (WHO) criteria. [Miller et al. Cancer 1981] Per WHO, evaluation of tumor measurements of measurable lesions centers on the percent change from baseline in the sum of the perpendicular diameters. Complete Response (CR) is disappearance of all clinical and laboratory evidence of disease; Partial Response (PR) is a >/= 50% decrease. PR status also requires no simultaneous increase in the size of any metastatic lesion, absence of one or more new metastatic lesions and/or unequivocal progression of existing non-target lesions. CR and PR status needs confirmation within 4 weeks. Response status was determined by investigator assessment of radiographs.|Disease was evaluated radiologically at baseline and during weeks 8 and 12 of each course. Participants received up to 3 courses of 12 weeks duration each. Median (range) days on treatment: 20 (1-262).|The analysis dataset is comprised of all treated patients.||proportion of participants||95% Confidence Interval|Number
859274|NCT00554515|Other Pre-specified|VHL Genotype Status|VHL genotype status will be determined based on establish methods.|Determined from baseline sample.||06/2018||||
859275|NCT00554515|Other Pre-specified|Serum Arginine Levels|Serum arginine levels will be determined based on establish immunohistochemical methods.|Determined from baseline sample.||06/2018||||
859276|NCT00554515|Other Pre-specified|KIR Genotype Status|Killer-immunoglobulin-like receptor (KIR) genotype status determined based on establish methods.|Determined from baseline sample.||06/2018||||
859277|NCT00554515|Secondary|Progression-Free Survival|Progression-free survival based on the Kaplan-Meier method is defined as the duration of time from treatment start to date of disease progression (PD) or death. Per WHO criteria: PD is a >/=25% increase in the sum of products of the perpendicular diameters of all measurable lesions. Further, PD is the appearance of one or more new metastatic lesions and/or unequivocal progression of existing non-target lesions. Participants who were event-free were censored at the date of their last disease evaluation.|Disease was evaluated radiologically at baseline and during weeks 8 and 12 of each course. Long-term follow-up occurred every 3 m for 2 yrs, semi-annually for yr 3 and annually for yrs 4 and 5. Median survival follow-up was X months (95% CI: ).|The analysis dataset is comprised of all treated patients.||months||95% Confidence Interval|Median
859278|NCT00554515|Secondary|Objective Response Rate by CA-9 SNP|The objective response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) on treatment based on World Health Organization (WHO) criteria. [Miller et al. Cancer 1981] Per WHO, evaluation of tumor measurements of measurable lesions centers on the percent change from baseline in the sum of the perpendicular diameters. Complete Response (CR) is disappearance of all clinical and laboratory evidence of disease; Partial Response (PR) is a >/= 50% decrease. PR status also requires no simultaneous increase in the size of any metastatic lesion, absence of one or more new metastatic lesions and/or unequivocal progression of existing non-target lesions. CR and PR status needs confirmation within 4 weeks. Response status was determined by independent assessment of radiographs.|Disease was evaluated radiologically at baseline and during weeks 8 and 12 of each course. Participants received up to 3 courses of 12 weeks duration each. Median (range) days on treatment: 20 (1-262).|The analysis dataset is comprised of all treated patients with available tumor tissue/data.||proportion of participants||95% Confidence Interval|Number
859279|NCT00554515|Secondary|Objective Response Rate by B7-H3 Tumor|The objective response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) on treatment based on World Health Organization (WHO) criteria. [Miller et al. Cancer 1981] Per WHO, evaluation of tumor measurements of measurable lesions centers on the percent change from baseline in the sum of the perpendicular diameters. Complete Response (CR) is disappearance of all clinical and laboratory evidence of disease; Partial Response (PR) is a >/= 50% decrease. PR status also requires no simultaneous increase in the size of any metastatic lesion, absence of one or more new metastatic lesions and/or unequivocal progression of existing non-target lesions. CR and PR status needs confirmation within 4 weeks. Response status was determined by independent assessment of radiographs.|Disease was evaluated radiologically at baseline and during weeks 8 and 12 of each course. Participants received up to 3 courses of 12 weeks duration each. Median (range) days on treatment: 20 (1-262).|The analysis dataset is comprised of all treated patients with available tumor tissue/data.||proportion of participants||95% Confidence Interval|Number
859280|NCT00554515|Secondary|Objective Response Rate by PD-L1 Tumor|The objective response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) on treatment based on World Health Organization (WHO) criteria. [Miller et al. Cancer 1981] Per WHO, evaluation of tumor measurements of measurable lesions centers on the percent change from baseline in the sum of the perpendicular diameters. Complete Response (CR) is disappearance of all clinical and laboratory evidence of disease; Partial Response (PR) is a >/= 50% decrease. PR status also requires no simultaneous increase in the size of any metastatic lesion, absence of one or more new metastatic lesions and/or unequivocal progression of existing non-target lesions. CR and PR status needs confirmation within 4 weeks. Response status was determined by independent assessment of radiographs.|Disease was evaluated radiologically at baseline and during weeks 8 and 12 of each course. Participants received up to 3 courses of 12 weeks duration each. Median (range) days on treatment: 20 (1-262).|The analysis dataset is comprised of all treated patients with available tumor tissue/data.||proportion of patients||95% Confidence Interval|Number
859281|NCT00554515|Secondary|Objective Response Rate by CA-9 Score (CAIX Classification)|The objective response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) on treatment based on World Health Organization (WHO) criteria. [Miller et al. Cancer 1981] Per WHO, evaluation of tumor measurements of measurable lesions centers on the percent change from baseline in the sum of the perpendicular diameters. Complete Response (CR) is disappearance of all clinical and laboratory evidence of disease; Partial Response (PR) is a >/= 50% decrease. PR status also requires no simultaneous increase in the size of any metastatic lesion, absence of one or more new metastatic lesions and/or unequivocal progression of existing non-target lesions. CR and PR status needs confirmation within 4 weeks. Response status was determined by independent assessment of radiographs.|Disease was evaluated radiologically at baseline and during weeks 8 and 12 of each course. Participants received up to 3 courses of 12 weeks duration each. Median (range) days on treatment: 20 (1-262).|The analysis dataset is comprised of all treated patients with available tumor tissue/data.||proportion of participants||95% Confidence Interval|Number
859282|NCT00554515|Secondary|Objective Response Rate by Clear Cell Histology Risk Group|The objective response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) based on World Health Organization (WHO) criteria. [Miller et al. Cancer 1981] Per WHO, evaluation of tumor measurements of measurable lesions centers on the percent change from baseline in the sum of the perpendicular diameters. Complete Response (CR) is disappearance of all clinical and laboratory evidence of disease; Partial Response (PR) is a >/= 50% decrease. PR status also requires no simultaneous increase in the size of any metastatic lesion, absence of one or more new metastatic lesions and/or unequivocal progression of existing non-target lesions. CR and PR status needs confirmation within 4 weeks.|Disease was evaluated radiologically at baseline and during weeks 8 and 12 of each course. Response status was confirmed by an independent assessment of radiographs. Participants received up to 3 courses of 12 weeks duration each.|The analysis dataset is comprised of all treated patients with available tumor tissue/data.||proportion of participants||95% Confidence Interval|Number
859283|NCT00554515|Secondary|Objective Response Rate by Tumor Type|The objective response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) on treatment based on World Health Organization (WHO) criteria. [Miller et al. Cancer 1981] Per WHO, evaluation of tumor measurements of measurable lesions centers on the percent change from baseline in the sum of the perpendicular diameters. Complete Response (CR) is disappearance of all clinical and laboratory evidence of disease; Partial Response (PR) is a >/= 50% decrease. PR status also requires no simultaneous increase in the size of any metastatic lesion, absence of one or more new metastatic lesions and/or unequivocal progression of existing non-target lesions. CR and PR status needs confirmation within 4 weeks. Response status was determined by independent assessment of radiographs.|Disease was evaluated radiologically at baseline and during weeks 8 and 12 of each course. Participants received up to 3 courses of 12 weeks duration each. Median (range) days on treatment: 20 (1-262).|The analysis dataset is comprised of all treated patients with available tumor tissue/data.||proportion of participants||95% Confidence Interval|Number
859284|NCT00554515|Secondary|Objective Response Rate by UCLA SANI Score|The objective response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) on treatment based on World Health Organization (WHO) criteria. [Miller et al. Cancer 1981] Per WHO, evaluation of tumor measurements of measurable lesions centers on the percent change from baseline in the sum of the perpendicular diameters. Complete Response (CR) is disappearance of all clinical and laboratory evidence of disease; Partial Response (PR) is a >/= 50% decrease. PR status also requires no simultaneous increase in the size of any metastatic lesion, absence of one or more new metastatic lesions and/or unequivocal progression of existing non-target lesions. CR and PR status needs confirmation within 4 weeks. Response status was determined by independent assessment of radiographs.|Disease was evaluated radiologically at baseline and during weeks 8 and 12 of each course. Participants received up to 3 courses of 12 weeks duration each. Median (range) days on treatment: 20 (1-262).|The analysis dataset is comprised of all treated patients with available tumor tissue/data.||proportion of participants||95% Confidence Interval|Number
859285|NCT00554515|Secondary|Objective Response Rate by MSKCC Risk Group|The objective response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) on treatment based on World Health Organization (WHO) criteria. [Miller et al. Cancer 1981] Per WHO, evaluation of tumor measurements of measurable lesions centers on the percent change from baseline in the sum of the perpendicular diameters. Complete Response (CR) is disappearance of all clinical and laboratory evidence of disease; Partial Response (PR) is a >/= 50% decrease. PR status also requires no simultaneous increase in the size of any metastatic lesion, absence of one or more new metastatic lesions and/or unequivocal progression of existing non-target lesions. CR and PR status needs confirmation within 4 weeks. Response status was determined by independent assessment of radiographs.|Disease was evaluated radiologically at baseline and during weeks 8 and 12 of each course. Participants received up to 3 courses of 12 weeks duration each. Median (range) days on treatment: 20 (1-262).|The analysis dataset is comprised of all treated patients with available tumor tissue/data.||proportion of participants||95% Confidence Interval|Number
859286|NCT00554515|Secondary|3-Year Progression-Free Survival Rate|3-year progression-free survival rate is defined as the proportion of patients absent death or progression based on WHO criteria by 3 years since time of treatment start. PD is a >/=25% increase in the sum of products of the perpendicular diameters of all measurable lesions. Further, PD is the appearance of one or more new metastatic lesions and/or unequivocal progression of existing non-target lesions.|Disease was evaluated radiologically at baseline and during weeks 8 and 12 of each course. Long-term follow-up occurred every 3 m for 2 yrs, semi-annually for yr 3 and annually for yrs 4 and 5. Relevant for this endpoint was disease status at 3 y.|The analysis dataset is comprised of all treated patients.||proportion of participants||95% Confidence Interval|Number
859287|NCT00554515|Secondary|Overall Survival|Overall survival based on the Kaplan-Meier method is defined as the time from treatment start to date of death or censored at the date of last documented contact.|Participants were followed for survival up to 7 years.|The analysis dataset is comprised of all treated patients.||months||95% Confidence Interval|Median
859288|NCT00554515|Secondary|Objective Response Rate (Independent Assessment)|The objective response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) on treatment based on World Health Organization (WHO) criteria. [Miller et al. Cancer 1981] Per WHO, evaluation of tumor measurements of measurable lesions centers on the percent change from baseline in the sum of the perpendicular diameters. Complete Response (CR) is disappearance of all clinical and laboratory evidence of disease; Partial Response (PR) is a >/= 50% decrease. PR status also requires no simultaneous increase in the size of any metastatic lesion, absence of one or more new metastatic lesions and/or unequivocal progression of existing non-target lesions. CR and PR status needs confirmation within 4 weeks.. Response status was determined by independent assessment of radiographs.|Disease was evaluated radiologically at baseline and during weeks 8 and 12 of each course. Participants received up to 3 courses of 12 weeks duration each. Median (range) days on treatment: 20 (1-262).|The analysis dataset is comprised of all treated patients.||proportion of participants||95% Confidence Interval|Number
859289|NCT00554515|Secondary|Objective Response Rate in ISM Poor Risk Group|The objective response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) based on treatment on World Health Organization (WHO) criteria. [Miller et al. Cancer 1981] Per WHO, evaluation of tumor measurements of measurable lesions centers on the percent change from baseline in the sum of the perpendicular diameters. Complete Response (CR) is disappearance of all clinical and laboratory evidence of disease; Partial Response (PR) is a >/= 50% decrease. PR status also requires no simultaneous increase in the size of any metastatic lesion, absence of one or more new metastatic lesions and/or unequivocal progression of existing non-target lesions. CR and PR status needs confirmation within 4 weeks. Response status was determined by independent assessment of radiographs.|Disease was evaluated radiologically at baseline and during weeks 8 and 12 of each course. Participants received up to 3 courses of 12 weeks duration each. Median (range) days on treatment: 20 (1-262).|The analysis dataset is comprised of all treated patients with available tumor tissue/data for ISM analysis and classified as ISM poor risk.||proportion of participants||95% Confidence Interval|Number
859290|NCT00554515|Primary|Objective Response in ISM Good Risk Group|The objective response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) on treatment based on World Health Organization (WHO) criteria. [Miller et al. Cancer 1981] Per WHO, evaluation of tumor measurements of measurable lesions centers on the percent change from baseline in the sum of the perpendicular diameters. Complete Response (CR) is disappearance of all clinical and laboratory evidence of disease; Partial Response (PR) is a >/= 50% decrease. PR status also requires no simultaneous increase in the size of any metastatic lesion, absence of one or more new metastatic lesions and/or unequivocal progression of existing non-target lesions. CR and PR status needs confirmation within 4 weeks. Response status was determined by investigator assessment of radiographs.|Disease was evaluated radiologically at baseline and during weeks 8 and 12 of each course. Participants received up to 3 courses of 12 weeks duration each. Median (range) days on treatment: 20 (1-262).|The analysis dataset is comprised of all treated patients with available tumor tissue/data for ISM analysis and classified as ISM good risk.||proportion of participants||95% Confidence Interval|Number
859291|NCT00483496|Secondary|Adverse Events||all over the study|||Participants|||Count of Participants
859292|NCT00483496|Primary|Assessment of the Minimal Urticaria Dose (MUD) on Each Test Site, After Application of the Test Products|"MUD was defined as the minimal dose for occurrence of objective signs of SU (wheal, flare) under exposure to the solar simulator. Results are expressed as photodermatosis protection factor (PPF), calculated by dividing the MUD of protected skin (sessions 2 to 5) by the MUD of the unprotected skin (session 1) in each treatment group.
Procedure: At baseline, 4 grids of 8 adjacent test areas on the patient back were defined. The defined test areas of each grid were applied with the respective test products by the investigating staff at the beginning of each session, according to a predefined randomisation schedule. Grids were sequentially irradiated one by one with 1 MUD (session 2) , 3 MUD (session 3) , 5 MUD (session 4), and 7 MUD (session 5), respectively. After product removal at each session, patients were observed for 30 min for the development of SU lesions. Final reading of all areas was performed at the end of each session, by the investigator masked to product site assignment."|During each one of the 5 sessions, at study day|||Photodermatosis Protection Factor||Full Range|Mean
859293|NCT00326417|Secondary|Overall Survival (OS)|OS is defined as alive at 1 year, the event is death from any cause. Patients alive at the time of last observation, for statistical purposes, will have a survival time which is censored.|Day 365|||percentage of participants||95% Confidence Interval|Number
859294|NCT00326417|Secondary|Chronic GVHD|Chronic GVHD is scored according to the BMT CTN MOP. The first day of chronic GVHD onset will be used to calculate cumulative incidence curves.|Day 365|||percentage of participants||95% Confidence Interval|Number
859295|NCT00326417|Secondary|Acute Graft vs Host Disease (GVHD)|All GVHD grades 2-4 will be graded according to the BMT CTN Manual of Procedures (MOP)|Day 100|||percentage of participants||95% Confidence Interval|Number
859296|NCT00326417|Secondary|Cumulative Incidence of Graft Failure|Primary and secondary graft failure are included, secondary graft failure is defined by initial neutrophil engraftment followed by subsequent decline in the ANC to less than 0.5 x 10^9/L for three consecutive measurements on different days, unresponsive to growth factor.|Day 365|||percentage of participants|||Number
859297|NCT00326417|Primary|Disease-free Survival (DFS)|DFS includes graft failure, regimen-related toxicity (RRT), and early death. Graft Failure is defined by lack of neutrophil engraftment (ANC less than 0.5 x 10^9/L for 3 consecutive days on different days). Major RRT is defined as severity of grade 4 in any organ system or grade 3 for pulmonary, cardiac, renal, oral mucosal or hepatic. Early death is defined as death prior to Day 100 post-transplant.|Day 100|||participants|||Number
859298|NCT00290693|Secondary|Rate of Toxicity in Study Participants|Rate of toxicity (serious adverse events or adverse events) in study participants receiving at least one cycle of protocol therapy.|Up to 1 year|Number of participants who received at least one dose of protocol therapy.||participants|||Number
859299|NCT00290693|Secondary|Rate of Participants Achieving a 50% or More Reduction in CA 19-9 Levels|Rate of participants achieving a 50% or more reduction in CA 19-9 levels after receiving protocol therapy. Baseline CA-19-9 will be compared to the lowest recorded value on patients receiving therapy on protocol. A 50% drop in CA 19-9 in patients with baseline levels above 100 U/ml will be recorded as a CA 19-9 response if the > 50% drop can be confirmed with at least one more CA 19-9 level thereafter with > 50% drop compared to baseline.|Up to 1 year|Participants who had available baseline CA19-9 levels above 100 U/ml.||participants|||Number
859300|NCT00290693|Secondary|Progression-free Survival (PFS)|Progression-free survival (PFS) is measured the time from the start of protocol therapy to disease progression or death from any cause.|Up to 1 year|Number of participants who completed at least one cycle of protocol therapy.||months||95% Confidence Interval|Median
859301|NCT00290693|Secondary|Overall Surival (OS)|Overall survival is measured from the time from date of initial protocol therapy to date of death. In the absence of confirmation of death, survival time will be censored to last date of follow-up.|Up to 1 year|Number of participants who completed at least one cycle of protocol therapy.||months||95% Confidence Interval|Median
859302|NCT00290693|Primary|Rate of Participants Achieving Complete Response or Partial Response to Therapy.|Rate of participants achieving complete response (CR) or partial response (PR) to Captere therapy according to RECIST criteria v 1.0. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.|Up to 1 year|Number of participants evaluable for response, that is, who completed at least one cycle of protocol therapy.||participants|||Number
859303|NCT00125762|Primary|Diagnostic Accuracy of VCTE for the Prediction of Metavir Fibrosis Scores by Differentiating no/Mild (F0/F1) From Severe Fibrosis (F2 - F4)|95% CI for Metavir Fibrosis stage 0 -1 consistent with no or mild fibrosis compared to Metavir 2 - 4 which represents significant fibrosis or cirrhosis|Liver Biopsy and VCTE within a time frame of 6 months|456 patients with matching liver biopsy and fibroscan||ROC area||95% Confidence Interval|Mean
859304|NCT00125762|Primary|Diagnosis Performance of VCTE for Determination of Cirrhosis (Metavir F4) in Patients With Chronic Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV)|VCTE was used to diagnose cirrhosis F4 in 748 patients undergoing liver biopsy and VCTE within a 28 day time period.|28 days|748 patients were eligible for analysis with matching valid liver biopsies and VCTE measurements.||ROC area||95% Confidence Interval|Mean
859909|NCT02507388|Primary|Concentration of RTH258 Obtained 24 Hours Post Day 56 Injection [C24hr (ng/mL)]|Serum concentration at the specified collection time point was quantitated, where possible, using a validated immunoassay method. The data were analyzed using a noncompartmental pharmacokinetic (PK) method.|Day 57|PK analysis set||ng/mL||Standard Deviation|Mean
859910|NCT02507388|Primary|Concentration of RTH258 Obtained 24 Hours Post Day 0 Injection [C24hr (ng/mL)]|Serum concentration at the specified collection time point was quantitated, where possible, using a validated immunoassay method. The data were analyzed using a noncompartmental pharmacokinetic (PK) method.|Day 1|PK analysis set||ng/mL||Standard Deviation|Mean
859911|NCT02507388|Primary|Elimination Half-life in Serum [t1/2 (h)]|Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental pharmacokinetic (PK) method.|Day 0 (predose), 6 hr, 24 hr, 72 hr, 168 hr, 336 hr, 504 hr, 672 hr|PK analysis set. Harmonic mean and jackknife estimate of the standard deviation are presented.||hours||Standard Deviation|Mean
859912|NCT02507388|Primary|Area Under the Concentration-time Curve From 0 to Infinity [AUC0-inf (ng*h/mL)]|Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental pharmacokinetic (PK) method.|Day 0 (predose), 6 hr, 24 hr, 72 hr, 168 hr, 336 hr, 504 hr, 672 hr|PK analysis set||ng*h/mL||Standard Deviation|Mean
859913|NCT02507388|Primary|Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC0-tlast (ng*h/mL)]|Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental pharmacokinetic (PK) method.|Day 0 (predose), 6 hr, 24 hr, 72 hr, 168 hr, 336 hr, 504 hr, 672 hr|PK analysis set||ng*h/mL||Standard Deviation|Mean
859914|NCT02507388|Primary|Time to Reach Maximum Analyte Serum Concentration [Tmax (h)]|Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental pharmacokinetic (PK) method.|Day 0 (predose), 6 hr, 24 hr, 72 hr, 168 hr, 336 hr, 504 hr, 672 hr|PK analysis set||hours||Standard Deviation|Mean
859915|NCT02507388|Primary|Maximum Analyte Serum Concentration [Cmax (ng/mL)]|Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental pharmacokinetic (PK) method.|Day 0 (predose), 6 hr, 24 hr, 72 hr, 168 hr, 336 hr, 504 hr, 672 hr|The PK analysis set included all subjects who received an intravitreal (IVT) injection with evaluable PK data and with no major protocol deviations that could have had an impact on the PK analysis.||ng/mL||Standard Deviation|Mean
859916|NCT02494076|Secondary|Rate of Inpatient Hospitalization|Count of patients admitted|After intervention or control and until follow-up phone call 72 hours after disposition|2 patients excluded due to missing data and protocol error||Participants|||Count of Participants
859917|NCT02494076|Secondary|Need for Additional Second Line Therapies After Administration of Intervention or Control|Second line therapies include: continuous albuterol, intravenous magnesium sulfate, subcutaneous or intravenous terbutaline, non-invasive ventilation (BiPAP or CPAP), and supplemental oxygen. The need for these second line therapies will be assessed by the child's treating team in the Emergency Department.|participants will be followed for the duration of ED stay, an expected average of 6-8 hours|2 subjects excluded from analysis due to missing data||Participants|||Count of Participants
859918|NCT02494076|Primary|Change in Pulmonary Asthma Score (PAS)|The primary outcome was the change in asthma severity as determined by change in Pulmonary Asthma Score (PAS) before and after administration of intervention (or control). The same trained, blinded physician assessor, who was not involved in the care of the patient, assessed PAS scores for study subjects before intervention (or control), and 15 minutes after completion of administration. The PAS is a pediatric asthma severity scoring system adapted from previously validated scores, and includes measures of respiratory rate, oxygen saturation, auscultory findings, retractions, and dyspnea. Values from each category are summed producing a total score between 5 and 15. Total scores < 7 correspond with mild asthma exacerbations, while scores ≥ 7 and < 12 indicate moderate asthma, and scores ≥12 to 15 indicate severe asthma.|0-30 minutes|2 patients in EzPAP group were excluded from analysis due to protocol error and missing data.||units on a scale||Standard Deviation|Mean
859919|NCT02493855|Primary|Slope of the Second Phase Decline in Plasma HCV Ribonucleic Acid (RNA) Levels During Treatment|HCV viral kinetics in plasma during therapy were modeled through non-linear mixed effect models, including a rapid first phase of initial decline and a slower second phase decline. The slope of the second phase decline was estimated for each treatment arm.|From Week 0 to Week 2|Participants with evaluable HCV RNA to calculate the slope of the second phase. Three participants were excluded due to algorithm non-convergence in the non-linear modeling process.||1/day||Full Range|Median
859920|NCT02480153|Primary|Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12 in the Intent-to-Treat (ITT) Population|ACR20 is a categorical variable indicating a 20% or greater improvement in tender and swollen joint counts and 20% or greater improvement in 3 of the 5 other ACR-core set measures: participant's assessment of arthritis pain; participant's global assessment of arthritis; physician's global assessment of arthritis; high sensitivity C-reactive protein (hs-CRP); and Health Assessment Questionnaire - Disability Index (HAQ-DI).|Week 0, week 2, week 4, week 6, week 8 and week 12|The Intent-to-Treat (ITT) population was defined as all participants who were randomized to study treatment. Non-responder imputation was applied.||percentage of participants|||Number
859921|NCT02471326|Secondary|Subjects Who Met Criteria to Restart Antiretroviral Therapy|The secondary endpoint was the number of subjects who met protocol defined virologic (sustained HIV RNA >1000 copies/mL by Abbott HIV RTPCR at 2 consecutive visits), immunologic (a confirmed >30% decline in CD4 cell count or an absolute CD4 cell count < 350 cells/mm3), or clinical criteria (HIV-related symptoms) to discontinue VRC01 infusions and restart Antiretroviral Therapy (ART).|From Day 3 post initial infusion until up to 28 weeks.|The analyses included all subjects who received at least one infusion of VRC-HIVMAB060-00-AB (VRCO1).||Participants|||Count of Participants
859922|NCT02471326|Primary|Number of Grade 3 or Higher Adverse Events|The primary endpoint was the number of grade 3 or higher adverse events, including serious adverse events, that were possibly related to VRC-HIVMAB060-00-AB (VRCO1).|From the start of the initial infusion until up to 48 weeks.|The analyses included all subjects who received at least one infusion of VRC-HIVMAB060-00-AB (VRCO1).||Events|||Number
859998|NCT01999920|Secondary|Change From Baseline Hamilton Rating Scale for Depression 17-item Total Score|This standard scale will be used to assess severity of depression, looking at change in total score from baseline to week 12, rating severity of depression on a scale from 0 (least depression) to 50 (greatest depression).|Up to 12 weeks|||units on a scale||Standard Deviation|Mean
859999|NCT01999920|Primary|Clinical Global Impression-Improvement Scale|"Clinical Global Impression-Improvement Scale rating at week 12 A quickly administered and widely used observer rating, with ratings from 1 (very much improved) to 7 (very much worse). Responder is a score of 1 or 2."|Up to 12 weeks|||Participants|||Count of Participants
860056|NCT01732822|Other Pre-specified|Major Amputation Caused by PAD|Participants with major amputation caused by PAD. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, death date)|From randomization to PACD, an average of 2.5 years|The population was the full analysis set, which included all randomized patients||Participant|||Number
859896|NCT03109769|Primary|Change in Gingival Index|Gingival index: 0, normal gingiva, 1, mild inflammation - slight change in color, slight edema and no bleeding on probing, 2, moderate inflammation - redness, edema and glazing and bleeding on probing, 3, severe inflammation - marked redness and edema, ulceration and tendency to spontaneous bleeding.|At baseline and after 4 weeks.|||units on a scale||Standard Deviation|Mean
859897|NCT03109769|Primary|Change in Plaque Index|Plaque index: 0, no plaque, 1, plaque seen on the tip of the explorer or with disclosing agent, 2. plaque seen with the naked eye, 3, abundance of plaque.|At baseline and after 4 weeks.|||units on a scale||Standard Deviation|Mean
859898|NCT02706327|Other Pre-specified|Vertical Jump Height Was Measured With a Special Mat|"Sensor mat was used in vertical jump measurement. The result is the distance (cm) that was jumped vertically and it is normalized by dividing the distance to length of subject in order to get percentage of jump distance.
Higher values mean better vertical jump performance. Participants were assessed after using the insoles for 8 weeks in order to get compliance.
Measurements were taken in the same day with and without insoles in shoes. Difference between with and without insole was calculated by subtracting the result with insole from the result without insole.
Therefore, positive changes mean better score with insole."|In the same session after 8 weeks|Two participants (1 CAD/CAM, 1 Semi-custom) did not bring their insole equipped shoes.||percentage of distance||Standard Deviation|Mean
859899|NCT02706327|Other Pre-specified|Six-minute Walk Physiological Cost Index Was Calculated|"Physiological cost index was calculated by taking heart rate with finger oximeter and walking distance after a six-minute walk test.
The result is calculated by dividing one minute heart rate (beat) to walking distance (meter).
Lower values mean better physiological cost. Participants were assessed after using the insoles for 8 weeks in order to get compliance.
Measurements were taken in the same day with and without insoles in shoes. Difference between with and without insole was calculated by subtracting the result with insole from the result without insole.
Therefore, negative changes mean better score with insole."|In the same session after 8 weeks|Two participants (1 CAD/CAM, 1 Semi-custom) did not bring their insole equipped shoes.||beat/meter||Standard Deviation|Mean
859900|NCT02706327|Other Pre-specified|Balance Was Assessed With a Dynamic Platform|"Dynamic platform was the equipment used in balance assessment. Participants were assessed after using the insoles for 8 weeks in order to get compliance.
Measurements were taken in the same day with and without insoles in shoes. The software calculates balance value between 0 and 5 that lower value means better balance score.
Difference between with and without insole was calculated by subtracting the result with insole from the result without insole.
Therefore, negative changes mean better balance score with insole."|In the same session after 8 weeks|Two participants (1 CAD/CAM, 1 Semi-custom) did not bring their insole equipped shoes.||units on a scale||Standard Deviation|Mean
859901|NCT02706327|Secondary|Change in Quality of Life Assessed With Short Form-36 Scale|"The scale scores the health related quality of life with 0 and 100, minimum and maximum levels.
Each question is scored between 0-100 and the total score is found by dividing to number of question.
Higher score or positive change mean better quality of life in the scale. We used physical health part of it.
Changes were calculated as the difference between 8-week follow-up and baseline results."|Baseline and week 8|||units on a scale||Standard Deviation|Mean
859902|NCT02706327|Primary|Change in Pain Intensity Measured by 100 mm Visual Analog Scale|"The scale scores the pain intensity with 0 and 100 mm, minimum and maximum levels.
Higher score means worse pain and also negative changes mean reduced pain. Participants were asked to rate the maximum level of foot pain they had in the last week.
Changes were calculated as the difference between 8-week follow-up and baseline results."|Baseline and week 8|||milimiters||Standard Deviation|Mean
859903|NCT02543398|Primary|Radiographic Bone Changes|The width and the height of the alveolar ridge will be measured (in mm) on the initial (i.e. following tooth extraction) Cone Beam CT and on the CBCT taken prior to implant placement (i.e. 3 months after tooth extraction)|3 months after tooth extraction|||millimeter||Standard Error|Mean
859904|NCT02526290|Other Pre-specified|Device-related Adverse Events|Number of subjects who experienced any device-related adverse events.|6 months|The safety population included all subjects who received an investigational device and initiated neurostimulation.||participants|||Number
859905|NCT02526290|Secondary|Slit Lamp Biomicroscopy|Number of subjects with clinically significant (CS) findings noted from the slit lamp biomicroscopy examinations. A slit lamp biomicroscopy examination of the eyelids, cornea, conjunctiva, anterior chamber, and lens was performed at each visit for each eye. The results were graded as normal, abnormal not clinically significant (NCS), or abnormal CS. In addition, the cornea was scored specifically for corneal edema using a 4-point scale (0=None, +1=Mild, +2=Moderate and +3=Severe). An increase in corneal edema grade of two or more was considered clinically significant and evaluated as a potential AE by the investigator.|6 months|The safety population included all subjects who received an investigational device and initiated neurostimulation.||participants|||Number
859906|NCT02526290|Secondary|Corrected Distance Visual Acuity|Change from baseline (Day 0) in corrected distance visual acuity at Day 180. Corrected visual acuity was obtained using the subject’s own glasses (for subjects that wear glasses) and measured in logMAR (log of the Minimum Angle of Resolution) units using an appropriate eye chart. A logMAR score of 0.0 is equivalent to a visual acuity of 20/20 and larger logMAR values indicate a poorer visual acuity (eg. A value of 0.3 corresponds to a visual acuity of 20/40).|Baseline and 6 months|The safety population included all subjects who received an investigational device and initiated neurostimulation.||LogMAR||Standard Deviation|Mean
859907|NCT02526290|Primary|Stimulated Acute Tear Production|Stimulated acute tear production in the study eye at Day 180 as measured by the difference between the Schirmer test score during stimulation and the test score before stimulation (basal). The Schirmer strip is placed just under the eyelid and wicks up the tears. It measures tear production on a linear scale of 0-35 mm.|The stimulated and prestimulation (basal) measures were both performed at Day 180.|The Full Analysis Set (FAS) population included all subjects who received an investigational device and initiated neurostimulation.||Scores on a scale||Standard Deviation|Mean
859908|NCT02507388|Secondary|Percentage of Subjects With Positive Anti-drug Antibody (ADA) Status (Test)|A positive ADA status is defined as induced ADA status with ADA negative at predose and with a post-dose titer value increase of 2 or more dilutions at any time point or boosted ADA status with ADA positive at predose and a post-dose titer value increase by more than 3-fold (1 dilution) at any time point.|Day 0 (predose), Day 28, Day 84|PK analysis set||percentage of participants|||Number
859923|NCT02452528|Secondary|Pharmacokinetics of Entecavir or Tenofovir: Time of Cmax (Tmax)||Through 24 hours post-dosing on Days 1 and 57|Pharmacokinetic evaluation was to be performed only on participants receiving ARC-520. At the time of study termination only 2 ARC-520 treated participants had been enrolled and therefore pharmacokinetic samples were not processed and no statistical analysis was performed.|||||
859924|NCT02452528|Secondary|Pharmacokinetics of Entecavir or Tenofovir: Cmax||Through 24 hours post-dosing on Days 1 and 57|Pharmacokinetic evaluation was to be performed only on subjects receiving ARC-520. At the time of study termination only 2 ARC-520 treated subjects had been enrolled and therefore pharmacokinetic samples were not processed and no statistical analysis was performed.|||||
859925|NCT02452528|Secondary|Pharmacokinetics of Entecavir or Tenofovir: AUClast||Through 24 hours post-dosing on Days 1 and 57|Pharmacokinetic evaluation was to be performed only on participants receiving ARC-520. At the time of study termination only 2 ARC-520 treated participants had been enrolled and therefore pharmacokinetic samples were not processed and no statistical analysis was performed.|||||
859926|NCT02452528|Secondary|Pharmacokinetics of Entecavir or Tenofovir: AUC0-24||Through 24 hours post-dosing on Days 1 and 57|Pharmacokinetic evaluation was to be performed only on participants receiving ARC-520. At the time of study termination only 2 ARC-520 treated participants had been enrolled and therefore pharmacokinetic samples were not processed and no statistical analysis was performed.|||||
859927|NCT02452528|Secondary|Pharmacokinetics of ARC-520: Terminal Elimination Half-Life (t1/2)||Through 48 hours post-dosing on Days 1 and 57|Pharmacokinetic evaluation was to be performed only on participants receiving ARC-520. At the time of study termination only 2 ARC-520 treated participants had been enrolled and therefore pharmacokinetic samples were not processed and no statistical analysis was performed.|||||
859928|NCT02452528|Secondary|Pharmacokinetics of ARC-520: Terminal Elimination Rate Constant (Kel)||Through 48 hours post-dosing on Days 1 and 57|Pharmacokinetic evaluation was to be performed only on participants receiving ARC-520. At the time of study termination only 2 ARC-520 treated participants had been enrolled and therefore pharmacokinetic samples were not processed and no statistical analysis was performed.|||||
859929|NCT02452528|Secondary|Pharmacokinetics of ARC-520: Apparent Volume of Distribution (V)||Through 48 hours post-dosing on Days 1 and 57|Pharmacokinetic evaluation was to be performed only on participants receiving ARC-520. At the time of study termination only 2 ARC-520 treated participants had been enrolled and therefore pharmacokinetic samples were not processed and no statistical analysis was performed.|||||
859930|NCT02452528|Secondary|Pharmacokinetics of ARC-520: Apparent Clearance (CL)||Through 48 hours post-dosing on Days 1 and 57|Pharmacokinetic evaluation was to be performed only on participants receiving ARC-520. At the time of study termination only 2 ARC-520 treated participants had been enrolled and therefore pharmacokinetic samples were not processed and no statistical analysis was performed.|||||
859931|NCT02452528|Secondary|Pharmacokinetics of ARC-520: Maximum Observed Plasma Concentration (Cmax)||Through 48 hours post-dosing on Days 1 and 57|Pharmacokinetic evaluation was to be performed only on participants receiving ARC-520. At the time of study termination only 2 ARC-520 treated participants had been enrolled and therefore pharmacokinetic samples were not processed and no statistical analysis was performed.|||||
859932|NCT02452528|Secondary|Pharmacokinetics of ARC-520: Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUCinf)||Through 48 hours post-dosing on Days 1 and 57|Pharmacokinetic evaluation was to be performed only on participants receiving ARC-520. At the time of study termination only 2 ARC-520 treated participants had been enrolled and therefore pharmacokinetic samples were not processed and no statistical analysis was performed.|||||
859933|NCT02452528|Secondary|Pharmacokinetics of ARC-520: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Quantifiable Plasma Concentration (AUClast)||Through 48 hours post-dosing on Days 1 and 57|Pharmacokinetic evaluation was to be performed only on participants receiving ARC-520. At the time of study termination only 2 ARC-520-treated participants had been enrolled and therefore pharmacokinetic samples were not processed and no statistical analysis was performed.|||||
859934|NCT02452528|Secondary|Pharmacokinetics of ARC-520: Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24)||Through 48 hours post-dosing on Days 1 and 57|Pharmacokinetic evaluation was to be performed only on participants receiving ARC-520. At the time of study termination only 2 ARC-520-treated participants had been enrolled and therefore pharmacokinetic samples were not processed and no statistical analysis was performed.|||||
859935|NCT02452528|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to Adverse Events (AEs)|An AE was defined as any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with treatment. An SAE was defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is a medically important event or reaction. An AE was classified as a TEAE if the AE was not present prior to the first study medication administration and started at or after the time of initiation of administration of study medication, or if the AE presented prior to initiation of administration of study medication, continued and increased in intensity after administration of study medication.|From time of informed consent through Day 147 ± 3 days|All participants who received at least 1 dose of ARC-520 or placebo||participants|||Number
859936|NCT02452528|Primary|Change From Baseline in Quantitative Hepatitis B Surface Antigen (Log qHBsAg) at Day 85||Baseline, Day 85|At the time of study termination only 2 ARC-520-treated and 2 placebo-treated participants had been enrolled. Due to the small sample size, analysis of this primary endpoint was not performed.|||||
859937|NCT02433483|Secondary|1-year Cumulative Incidence of Chronic Graft Versus Host Disease (GVHD)|All grades of GVHD will be reported.|From start of therapy through completion of therapy (approximately 1 year)|No patient survived long enough to evaluate chronic GVHD.|||||
859938|NCT02433483|Other Pre-specified|Percent Donor Chimerism|Percent donor chimerism in blood and bone marrow.|At weeks 1, 2, 3, and 4 after infusion of HPC-A|||Percentage of donor chimerism||Full Range|Mean
860057|NCT01732822|Other Pre-specified|Any Amputation Caused by PAD|Participants with any amputation caused by peripheral arterial disease (PAD). If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, death date)|From randomization to PACD, an average of 2.5 years|The population was the full analysis set, which included all randomized patients||Participant|||Number
859939|NCT02433483|Secondary|1-year Cumulative Incidence of Acute Graft Versus Host Disease (GVHD)|"Children’s Oncology Group (COG) Stem Cell Committee Consensus Guidelines for Establishing Organ Stage and Overall Grade of Acute Graft Versus Host Disease (GVHD) were used. Overall clinical grade was based on the highest stage obtained:
Grade 0: no stage 1-4 of any organ
Grade I: stage 1-2 skin and no liver or gut involvement
Grade II: stage 3 skin, or stage 1 liver involvement, or stage 1 GI
Grade III: stage 0-3 skin, with stage 2-3 liver, or stage 2-3 GI
Grade IV: stage 4 skin, liver or GI involvement"|From start of therapy through completion of therapy (approximately 1 year)|||Participants|||Count of Participants
859940|NCT02433483|Secondary|Time to Platelet Recovery|"The time to platelet recovery will be summarized using descriptive statistics. If there are no deaths prior to recovery of platelets, nonparametric confidence intervals for the median time to recovery will be computed by inverting the sign test. Otherwise, we will compute cumulative incidence curves to describe the time to platelet and neutrophil recovery while adjusting for competing events.
Due to the small number of patients enrolled, the data is presented by patient."|From start of therapy to completion of therapy (approximately 1 year)|Platelet recovery for Patient #1 could not be determined due to transfusions.||days|||Number
859941|NCT02433483|Secondary|Median Time to Neutrophil Recovery|The time to neutrophil recovery will be summarized using descriptive statistics. If there are no deaths prior to recovery of neutrophils, nonparametric confidence intervals for the median time to recovery will be computed by inverting the sign test. Otherwise, we will compute cumulative incidence curves to describe the time to platelet and neutrophil recovery while adjusting for competing events.|From start of therapy to completion of therapy (approximately 1 year)|||Days||Full Range|Median
859942|NCT02433483|Secondary|3-year Overall Survival (OS)|We will use the Kaplan-Meier method to describe overall survival. Overall survival will be defined as the time from enrollment to death, with living subjects’ time censored at the date of last follow-up|3 years after enrollment of the last participant|||Percentage of participants|||Number
859943|NCT02433483|Secondary|3-year Event Free Survival (EFS)|We will use the Kaplan-Meier method to describe event-free survival. EFS will be defined as the time from enrollment to death, relapse, or refractory disease with event-free subjects’ time censored at the date of last follow-up.|3 years after enrollment of the last participant|||Percentage of participants|||Number
859944|NCT02433483|Primary|Proportion of Participants Who Experience Therapeutic Success|"All patients will be counted towards this two-stage design. Therapeutic success for patients at time of enrollment is defined as:
Patients with fewer than 5% blasts, a ≥ 10-fold decrease in level of minimal residual disease after completion of 1 or 2 cycles of therapy.
Patients with greater than 5% in leukemic blasts in the marrow, achieving CR or CRi after completion of 1 or 2 cycles of therapy.
In terms of efficacy, patients who die before achieving therapeutic success will be counted as a failure, and all patients who receive ≥ 1 dose of protocol chemotherapy will be counted as a failure or success. Only subjects who withdraw or die prior to receiving the first dose of protocol chemotherapy will be considered inevaluable and replaced. The evaluation of tolerability and this phase II design will be performed concurrently, i.e., the first enrollees will be counted for both tolerability and efficacy."|At the end of therapy cycle 2 (approximately 2-3 months)|||proportion|||Number
859945|NCT02433483|Primary|Number of Participants by Stratum Who Complete 2 Cycles of Therapy|If two or more patients die from causes other than leukemia progression or experience ≥ Grade 3 GVHD that is associated with detectable donor chimerism due to this protocol, or demonstrate persistent engraftment defined as >5% donor chimerism at the time of count recovery (ANC > 0.3 x 10^9/L and platelet count > 30 x 10^/L), then the cohort will close due to intolerability. Any subject who transfers to transplant prior to completion of two courses without experiencing an unacceptable toxicity is considered inevaluable for purposes of evaluating tolerability. Accrual will be halted for intolerability if there are two or more failures in tolerability among the first six subjects who are evaluable for tolerability.|At the end of therapy cycle 2 (approximately 2-3 months)|||Participants|||Count of Participants
859946|NCT02390219|Secondary|Absolute Change From Baseline in Cystic Fibrosis Questionnaire – Revised (CFQ-R) Respiratory Domain Score Through Week 24|The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), the scaled score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life. Results were reported as planned, as a combined single LUM/IVA arm irrespective of permitted dose modification.|Baseline, Through Week 24|"FAS included all participants who were enrolled and administered any amount of study drug. Here, Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure."||Units on a scale||Standard Error|Least Squares Mean
859947|NCT02390219|Secondary|Absolute Change From Baseline in Sweat Chloride at Average of Day 15 and Week 4|Sweat samples were collected using an approved collection device. Baseline was defined as the average of the measurements at screening and on Day 1 pre-dose. The average absolute change from baseline in sweat chloride was derived as: (Average of Day 15 and Week 4 value) minus Baseline value. Results were reported as planned, as a combined single LUM/IVA arm irrespective of permitted dose modification.|Baseline, Day 15 and Week 4|"FAS included all participants who were enrolled and administered any amount of study drug. Here, Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure."||Millimoles per litre (mmol/L)||Standard Error|Median
859948|NCT02390219|Secondary|Number of Hospitalizations|Number of hospitalizations (all causes) through Week 24 was summarized. Results were reported as planned, as a combined single LUM/IVA arm irrespective of permitted dose modification.|Baseline through Week 24|"FAS included all participants who were enrolled and administered any amount of study drug. Here, Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure."||Hospitalizations|||Number
859949|NCT02390219|Secondary|Duration For Which Participants Received Intravenous (IV) Antibiotics|The duration for which participants received IV antibiotics for sinopulmonary signs and symptoms were reported. Results were reported as planned, as a combined single LUM/IVA arm irrespective of permitted dose modification.|Baseline through Week 24|"FAS included all participants who were enrolled and administered any amount of study drug. Here, Number of Participants Analyzed signifies those participants who received at least one IV antibiotic for sinopulmonary signs and symptoms."||Days||Standard Deviation|Mean
860142|NCT01641471|Primary|Narcotic Usage|Measured as the amount of pain medication and equianalgesic equivalents to morphine.|Through 6 weeks after surgery|||morphine equivalents||Standard Deviation|Mean
859950|NCT02390219|Secondary|Absolute Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Up to Week 24|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate FEV1 (for age, gender, race, and height). The Hankinson standard was used for male participants 18 years and older and female participants 16 years and older. The Wang standard was used for male participants aged 12 to 17 years and for female participants aged 12 to 15 years. Results were reported as planned, as a combined single LUM/IVA arm irrespective of permitted dose modification.|Baseline, Up to Week 24|"FAS included all participants who were enrolled and administered any amount of study drug. Here, Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure."||Liter (L)||Standard Error|Least Squares Mean
859951|NCT02390219|Secondary|Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Up to Week 24|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, and height). The Hankinson standard was used for male participants 18 years and older and female participants 16 years and older. The Wang standard was used for male participants aged 12 to 17 years and for female participants aged 12 to 15 years. Results were reported as planned, as a combined single LUM/IVA arm irrespective of permitted dose modification.|Baseline, Up to Week 24|"Full Analysis Set (FAS) included all participants who were enrolled and administered any amount of study drug. Here, Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure."||Percent predicted of FEV1||Standard Error|Least Squares Mean
859952|NCT02390219|Primary|Number of Participants With Treatment Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|AE: any untoward medical occurrence in a participant during the study; event does not necessarily have a causal relationship with treatment. This includes any newly occurring event/previous condition that has increased in severity/frequency after informed consent form is signed. AE includes serious as well as non-serious AEs. SAE (subset of AE): medical event, which falls into any of the following categories, regardless of its relationship to study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. TEAEs: AEs that started/ worsened on/after the start of study drug through the Safety Follow up Visit (4 weeks after the last dose of study drug). Results were reported as planned, as a combined single LUM/IVA arm irrespective of permitted dose modification.|Day 1 up to Week 28|Safety Set included all participants who were exposed to any amount of study drug.||Participants|||Number
859953|NCT02340715|Primary|Number of Participants Successfully Contributing MRI Data|We tested these Advanced MR protocols to evaluate which ones would best visualize the target region. This helped us determine the optimum MR SIM protocols for different sites that became clinical standard.|up to 4 weeks from imaging|||Participants|||Count of Participants
859954|NCT02301975|Secondary|Change From Baseline in PM PEF|PEF was measured using an electric flow meter each evening. Change from Baseline (defined as the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily PM PEF over the 24-week treatment period minus the Baseline value. Statistical analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age and treatment and least square mean and standard error were calculated.|Baseline and Weeks 1-24|ITT Population||L/min||Standard Error|Least Squares Mean
859955|NCT02301975|Secondary|Percentage of Participants With Asthma Control Test (ACT) Score Greater Than or Equal to 20|The ACT was a five-item questionnaire developed as a measure of participant’s asthma control. The percentage of participants controlled, defined as having ACT score greater than or equal to 20 at the end of Week 24 were analyzed using logistic regression model with covariates of Baseline ACT score, region, sex, age and treatment group.|Week 24|ITT Population||Percentage of participants|||Number
859956|NCT02301975|Secondary|Change From Baseline in Morning (Ante Meridiem [AM]) Peak Expiratory Flow (PEF)|PEF was measured using an electric flow meter each morning. Change from Baseline (defined as the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily AM PEF over the 24-week treatment period minus the Baseline value. Statistical analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age and treatment and least square mean and standard error were calculated.|Baseline and Weeks 1-24|ITT Population||Liter per minute (L/min)||Standard Error|Least Squares Mean
859957|NCT02301975|Secondary|Change From Baseline in the Percentage of Symptom-free 24-hour Periods|Change from Baseline in the percentage of symptom-free 24 hour period was evaluated. A 24-hour (hr) period in which a participant’s responses to both the morning and evening assessments indicated no symptoms was considered to be symptom free. The Baseline value was derived from the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 24-week treatment period minus the Baseline value.Statistical analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age and treatment and least square mean and standard error were calculated.|Baseline and Weeks 1-24|ITT Population||Percentage of symptom-free 24 hour perio||Standard Error|Least Squares Mean
859958|NCT02301975|Secondary|Change From Baseline in the Percentage of Rescue-free 24-hour Periods|The number of inhalations of rescue medication used during the day and night were recorded by participants using an electronic diary (e-diary). A 24-hour (hr) period in which a participant’s responses to both the morning and evening assessments indicated no use of rescue medication was considered to be rescue free. The Baseline value was derived from the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 24-week treatment period minus the Baseline value. Statistical analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of Baseline, region, sex, age and treatment and least square mean and standard error were calculated.|Baseline and Weeks 1-24|ITT Population||Percentage of rescue-free 24-hr periods||Standard Error|Least Squares Mean
859996|NCT01999920|Secondary|Change From Baseline in Quality of Life Enjoyment & Satisfaction Questionnaire|Measure Description: (10 min) Quality of Life Enjoyment & Satisfaction Questionnaire (Q-LES-Q, Endicott et al, 1993): self-rated assessment of quality of life. 16 items related to life quality, each rated on a score of 1 (very poor) to 5 (very good), with a minimum total score of 16, and a maximum total score of 80.|Up to 12 weeks|||units on a scale||Standard Deviation|Mean
859959|NCT02301975|Primary|Change From Baseline in PM FEV1 Using Per Protocol (PP) Population|FEV1 was defined as the volume of air that can be forced out in one second after taking a deep breath. FEV1 (pre-bronchodilator and pre-dose) was measured at Baseline up to Week 24 at evening using spirometry. Repeated Measures analysis was adjusted for Baseline, region, sex, age, treatment, visit, visit by Baseline interaction and visit by treatment interaction. Visit 3 values were taken as Baseline value and change from Baseline was defined as the difference between the value of the endpoint at the time point of interest and the Baseline value. Statistical analysis was performed using the MMRM models and least square mean and standard error were calculated. The analysis was performed on PP Population which comprised of all participants in the ITT Population who did not had any full protocol deviations.|Baseline and Week 24|PP Population||L||Standard Error|Least Squares Mean
859960|NCT02301975|Primary|Change From Baseline in Evening (Post Meridiem [PM]) Forced Expiratory Volume in One Second (FEV1) Using Intent-to-Treat (ITT) Population|FEV1 was defined as the volume of air that can be forced out in one second after taking a deep breath. FEV1 (pre-bronchodilator and pre-dose) was measured at Baseline up to Week 24 at evening using spirometry. Repeated Measures analysis was adjusted for Baseline, region, sex, age, treatment, visit, visit by Baseline interaction and visit by treatment interaction. Visit 3 values were taken as Baseline value and change from Baseline was defined as the difference between the value of the endpoint at the time point of interest and the Baseline value. Statistical analysis was performed using the mixed model repeated measures (MMRM) model and least square mean and standard error were calculated. The analysis was performed on ITT Population which comprised of all participants randomized to treatment and who received at least one dose of study medication.|Baseline and Week 24|ITT population||Liter (L)||Standard Error|Least Squares Mean
859961|NCT02229383|Secondary|Change in Seated SBP From Baseline to Week 28|To compare the change from baseline in seated systolic blood pressure achieved with EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment.|Baseline to Week 28|All randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.||mmHg||95% Confidence Interval|Least Squares Mean
859962|NCT02229383|Secondary|Percentage of Patients Achieving HbA1c <7.0% at Week 28, no Weight Gain at Week 28, and no Major Hypoglycemia Over 28 Weeks|To compare the percentage of patients achieving HbA1c <7.0% at Week 28, no weight gain at Week 28, and no major hypoglycemia over 28 weeks between EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin.|Baseline to Week 28|All randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.||% of patients||95% Confidence Interval|Number
859963|NCT02229383|Secondary|Change From Baseline to Week 28 in Daily Insulin Dose|To compare the change from baseline in daily insulin dose achieved with EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment.|Baseline to Week 28|All randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.||units||95% Confidence Interval|Least Squares Mean
859964|NCT02229383|Secondary|Percentage of Patients Achieving HbA1c <7.0% at Week 28|To compare the percentage of patients achieving HbA1c <7.0% between EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment.|Baseline to Week 28|All randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.||% of patients||95% Confidence Interval|Number
859965|NCT02229383|Secondary|Change From Baseline to Week 28 in 2-hour Postprandial Glucose After a Standard Meal Tolerance Test|To compare the change from baseline in 2-hour postprandial glucose after a standard Meal Tolerance Test achieved with EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment.|Baseline to Week 28|All randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.||mg/dL||95% Confidence Interval|Least Squares Mean
859966|NCT02229383|Secondary|Change in Body Weight From Baseline to Week 28|To compare the change from baseline in body weight achieved with EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment.|Baseline to Week 28|All randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.||kg||95% Confidence Interval|Least Squares Mean
859967|NCT02229383|Primary|Change in HbA1c From Baseline to Week 28|To compare the change from baseline in HbA1c achieved with EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment.|Baseline to Week 28|All randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.||% HbA1c||95% Confidence Interval|Least Squares Mean
859968|NCT02210000|Secondary|Trough Plasma Concentration of Camicinal on Day 28 and Day 84|A pre-dose blood sample was collected on Days 28 and 84 for pharmacokinetic analysis. This analysis was applicable only for Camicinal arm and thus, no participants from Placebo arm were analyzed.|Day 28 and Day 84|Safety Population. One participant randomized to Placebo arm had quantifiable concentration of Camicinal in blood and therefore was analyzed in the Camicinal group.||NANOGRAM PER MILLILITER (NG/ML)||Standard Deviation|Mean
859969|NCT02210000|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs), and Adverse Events Leading to Discontinuation of the Study Drug|An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Serious adverse event (SAE) is an adverse event that results in death, is life-threatening, requires inpatient hospitalization or extends a current hospital stay, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect. Medical events that do not result in death, are not life-threatening, or do not require hospitalization may be considered serious adverse events if they put the participant in danger or require medical or surgical intervention to prevent one of the results listed above. Any AE or SAE that led discontinuation of the study drug either by participant or by investigator was considered as an AE leading to discontinuation of the study drug.|Up to end of follow up (100 days)|Safety Population. One participant randomized to Placebo arm had quantifiable concentration of Camicinal in blood and therefore was analyzed in the Camicinal group.||Participants|||Count of Participants
859970|NCT02210000|Secondary|Number of Participants With Change From Baseline Clinical Chemistry Abnormalities of PCI by Treatment and Visit Over Period|Clinical chemistry laboratory analysis was performed at screening (fasted) and during the study at each indicated time point. Albumin low (<30 G/L), calcium low (<2 or >2.75 millimoles per Liter [mmol/L]), creatinine (>44 micromoles per Liter change from baseline), Glucose (<3 or >18 mmol/L), potassium (<3.0 or >5.5 mmol/L), sodium (<130 or >150 mmol/L), and carbon di oxide (CO2) (<18 or >35 mmol/L) were analyzed for their low (L) or high (H) values. Participants with abnormalities in changes from Baseline values were recorded. Change from Baseline is the post-Baseline value minus the Baseline value.|Up to 100 days|Safety Population. One participant randomized to Placebo arm had quantifiable concentration of Camicinal in blood and therefore was analyzed in the Camicinal group.||Participants|||Count of Participants
859971|NCT02210000|Secondary|Number of Participants With Change From Baseline in Hematological Abnormalities of PCI by Treatment and Visit Over Period|Hematology analysis was performed at screening (fasted) and during the study at each indicated time point. Participants with abnormalities in changes from Baseline values were recorded. Total absolute neutrophil count (tANC <1.5 Giga per Liter [G/L]), hemoglobin (<25 or >25 G/L), hematocrit (<0.075 or >0.075 %), platelet count (<100 or >500 G/L), lymphocytes low (<0.8 G/L), and white blood cells (WBC <3 G/L or >20G/L) were analyzed for their low (L) or high (H) values. Change from Baseline (CFB) was the post-Baseline value minus then Baseline value. Baseline was defined as last non-missing measurement prior to dosing. One participant was randomized to Placebo arm; however, was included within the Camicinal treatment group as they reported at least one PK trough concentration >53 nano-grams per milliliter (ng/mL).|Up to 100 days|Safety Population. One participant randomized to Placebo arm had quantifiable concentration of Camicinal in blood and therefore was analyzed in the Camicinal group.||Participants|||Count of Participants
859972|NCT02210000|Secondary|Number of Participants With Normal and Abnormal 12-lead Electrocardiogram (ECG) Measurements Over 100 Days|The 12-lead ECG was analyzed as a measure of safety and tolerability. Number of participants with normal ECG, abnormal clinically significant, and abnormal clinically not significant ECG were reported. PR interval of < 110 and > 220 milliseconds (msec), QRS interval of <75 and > 110 msec, absolute QTc interval of > 450 to ≤ 480 or > 480 to ≤ 500 or >500 msec, and increase from Baseline in QTc of > 30 to ≤ 60 msec or >60 msec was considered as of abnormal.|Up to 100 days|Safety Population. One participant randomized to Placebo arm had quantifiable concentration of Camicinal in blood and therefore was analyzed in the Camicinal group.||Participants|||Count of Participants
859973|NCT02210000|Secondary|Number of Participants With Change From Baseline (Day 1) in Heart Rate of PCI Over 100 Day|Abnormal values of heart rate over 100 days was analyzed and reported. Participants were counted only once per parameter. Participant may have had more than 1 abnormal parameter. Only worst post baseline CFB values were considered. The categories mentioned for data values indicate the heart rate ranges of clinical concern.|Up to 100 days|Safety Population. One participant randomized to Placebo arm had quantifiable concentration of Camicinal in blood and therefore was analyzed in the Camicinal group.||Participants|||Count of Participants
859974|NCT02210000|Secondary|Number of Participants With Change From Baseline (Day 1) in Blood Pressure of Potential Clinical Importance (PCI) Over 100 Days|Abnormal values of systolic and diastolic blood pressure were measured. If the value for a participant at a given visit was outside the PCI, the participants were further categorized as per the increase or decrease of systolic blood pressure (SBP) and diastolic blood pressure (DBP) from Baseline by 10, 20 and 40 millimeters of mercury (mm of Hg). Number of participants with absolute (ABS) SBP (>160 mm Hg) and ABS DBP (100 mm Hg) were also analyzed. Change from Baseline (CFB) is the post-Baseline value minus the Baseline value. Participants were counted only once per parameter. Participant may have had more than 1 abnormal parameter. Only worst post-Baseline CFB values were considered. The categories mentioned for data values indicate the blood pressure ranges of clinical concern.|Up to 100 days|Safety Population comprised of participants who received at least one dose of the study drug and were followed-up for at least one post-Baseline safety assessment; however, one participant randomized to Placebo arm had quantifiable concentration of Camicinal in blood and therefore was analyzed in the Camicinal group.||Participants|||Count of Participants
859975|NCT02210000|Secondary|Change From Baseline in Individual Items, Subscales and Total Score of GCSI-DD at Week 12|Items of GCSI-DD for gastroparesis (GP) symptom assessment included: 3-nausea, 4-feeling full after meals, 5-bloating, 6-unable to finish normal meal, 7-retching, 8-vomiting, 9-stomach visibly larger, 10-stomach fullness, 11-loss of appetite, 12-upper abdominal pain, 13-upper abdominal discomfort and 14-overall severity of GP symptoms. Each symptom was rated on a 6-point scale from 0 to 5 where 0 indicated absence of symptom and higher score indicated greater severity of symptom. Score of nausea/vomiting subscale was mean of items 3, 7 and 8, fullness/early satiety subscale was mean of items 4, 6, 10 and 11 and bloating subscale was mean of items 5 and 9; higher score indicated greater severity. Total GCSI-DD score was mean of 3 subscales; higher score indicated greater severity. Baseline was defined as weekly average of last 7 daily scores recorded during screening period. Change from Baseline was calculated by subtracting mean score for Baseline from weekly average score of Week 12.|Baseline (Screening) and Week 12|ITT Population. Only those participants available at the time of assessment were included in the analysis.||Scores on a scale||Standard Error|Least Squares Mean
859976|NCT02210000|Primary|Percentage of Responders Based on the Fullness/Early Satiety Subscale (Responders) as Assessed by Gastrointestinal Cardinal Symptom Index-Daily Diary (GCSI–DD) at Week 12|The GCSI-DD consists of nine symptom severity items covering the following domains: nausea/vomiting; fullness/early satiety, and bloating. In addition, the GCSI-DD contains two symptom severity items upper abdominal pain and overall rating of gastroparesis symptoms. Participants were asked to rate each symptom on a 6-point scale from 0 to 5 with lower scores representing less symptom severity and higher scores indicating more severe symptoms. Fullness/early satiety response is defined as an improvement from Baseline by at least one point in the weekly average for the subscale. A participant was defined as a responder if the participant's weekly average change from Baseline in the fullness/early satiety response score improved by at least 1 point. Percentage of participants showing response were presented.|Week 12|Intent-to-treat (ITT) Population comprised of all randomized participants.||Percentage of responders|||Number
860177|NCT01454076|Secondary|Number of Participants With Clinically Significant Vital Sign Abnormalities||Cycle 1 Day 1 up to 30 days after last dose of study drug (Arm 1 and 5: Cycle 19 Day 45; Arm 2: Cycle 7 Day 45; Arm 3: Cycle 22 Day 45; Arm 4: Cycle 25 Day 45|The safety population included all participants who received at least one dose of any study drug.||participants|||Number
859977|NCT02164916|Other Pre-specified|Overall Response Rate in Patients Who Register to Arm 3 (Crossover) After Disease Progression on Arm 1|Confirmed response (CR) is two or more objective statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration. Partial response (PR) is two or more objective statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration. Unconfirmed CR is one objective status of CR documented before progression or symptomatic deterioration but not qualifying as CR or PR. Unconfirmed PR is one objective status of PR documented before progression or symptomatic deterioration but not qualifying as CR, PR or unconfirmed CR.|Up to 3 years from randomization|Eligible and analyzable patients with measurable disease.||Participants|||Count of Participants
859978|NCT02164916|Other Pre-specified|Overall Survival in Patients Who Register to Arm 3 (Crossover) After Disease Progression on Arm 1|From date of randomization to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Up to 3 years from randomization|Eligible and analyzable patients||months||95% Confidence Interval|Median
859979|NCT02164916|Other Pre-specified|Progression-free Survival in Patients Who Register to Arm 3 (Crossover) After Disease Progression on Arm 1|From date of Step 3 Crossover registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive without report of progression are censored at date of last contact. Progression is defined as one or more of the following: 20% increase in the sum of appropriate diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline, as well as an absolute increase of at least 0.5 cm; unequivocal progression of non-measurable disease in the opinion of the treating physician; appearance of any new lesion/site; and/or death due to disease without prior documentation of progression and without symptomatic deterioration.|Up to 3 years from randomization|All eligible and analyzable patients.||months||95% Confidence Interval|Median
859980|NCT02164916|Other Pre-specified|Overall Response Rate|Confirmed response (CR) is two or more objective statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration. Partial response (PR) is two or more objective statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration. Unconfirmed CR is one objective status of CR documented before progression or symptomatic deterioration but not qualifying as CR or PR. Unconfirmed PR is one objective status of PR documented before progression or symptomatic deterioration but not qualifying as CR, PR or unconfirmed CR.|Up to 3 years from randomization|All eligible and analyzable patients with measurable disease.||Participants|||Count of Participants
859981|NCT02164916|Other Pre-specified|Overall Survival|From date of randomization to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Up to 3 years from randomization|Eligible and analyzable patients||months||95% Confidence Interval|Median
859982|NCT02164916|Secondary|Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Up to 3 years|Eligible patients who received any treatment and were assessed for adverse events are included in this summary.||Participants|||Number
859983|NCT02164916|Primary|Progression-free Survival|From date of randomization to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact. Progression is defined as one or more of the following: 20% increase in the sum of appropriate diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline, as well as an absolute increase of at least 0.5 cm; unequivocal progression of non-measurable disease in the opinion of the treating physician; appearance of any new lesion/site; and/or death due to disease without prior documentation of progression and without symptomatic deterioration.|Up to 3 years from randomization|Eligible and analyzable patients.||months||95% Confidence Interval|Median
859984|NCT02116309|Secondary|Number of Patients Who Developed Severe Post-ERCP Pancreatitis|Severity of PEP defined using the consensus grading as Mild PEP that results in hospitalization (or prolongation of existing hospitalization) for ≤3 days. Moderate PEP will be defined as PEP that results in hospitalization (or prolongation of existing hospitalization) for 4-10 days. Severe PEP will be defined as PEP that results in hospitalization (or prolongation of existing hospitalization) for > 10 days, or leads to the development of pancreatic necrosis or pseudocyst, or requires additional endoscopic, percutaneous, or surgical intervention.|up to 30 days after ERCP|||Participants|||Count of Participants
859985|NCT02116309|Primary|Number of Patients Who Developed Post-ERCP Pancreatitis|The primary outcome variable of interest is the incidence of post ERCP pancreatitis (PEP) as defined by the consensus guidelines as 1) New or increased abdominal pain that is clinically consistent with a syndrome of acute pancreatitis and 2) amylase or lipase ≥ 3x the upper limit of normal 24 hours after the procedure and 3) Hospitalization or prolongation of existing hospitalization for at least 2 days.|24 hours after ERCP|||Participants|||Count of Participants
859986|NCT02099110|Secondary|Change From Baseline in Sitting Systolic Blood Pressure at Week 26: Excluding Rescue Approach|This change from baseline reflects the Week 26 systolic blood pressure minus the Week 0 systolic blood pressure. Excluding recue approach data analysis excluded all data following the initiation of rescue therapy at any time point, in order to avoid the confounding influence of the rescue therapy.|Baseline and Week 26|The analysis population consisted of all randomized participants who received at least one dose of study treatment, had a baseline measurement or a post-randomization measurement for the systolic blood pressure change from baseline at Week 26 analysis endpoint subsequent to at least one dose of study treatment.||mm Hg||95% Confidence Interval|Least Squares Mean
859997|NCT01999920|Secondary|Change From Baseline in Attachment Style Questionnaire Score|Measure Description: (15 min) Attachment Style Questionnaire (Feeney at al., 1994) 40 items relating to quality of adult relationships. Questionnaire includes questions concerning Confidence (8 items, minimum score=8, maximum score=48), Discomfort (10 items, minimum score=10, maximum score=60), Relationships as Secondary (7 items, minimum score=7, maximum score=42), Need for Approval (7 items, minimum score=7, maximum score =42), and Preoccupation with Relationships (8 items, minimum score = 8, maximum score=48), each self-rated on a six-point scale, each self-rated from 1 (totally disagree) to 6 (totally agree).|Up to 12 weeks|||units on a scale||Standard Deviation|Mean
859987|NCT02099110|Secondary|Change From Baseline in Static Beta-Cell Sensitivity to Glucose Index at Week 26; Excluding Rescue Approach|Static beta-cell sensitivity to glucose index (SBCSGI) estimates the ratio of insulin secretion (expressed in pmol/min) related to above-basal glucose concentration (expressed in mmol/L * L) following a meal. Blood samples were collected before and after a standard meal and glucose, insulin, and C-peptide levels were analyzed. The C-peptides minimal model was used to estimate the insulin secretion rate (ISR). Analysis included both non-model-based [including insulinogenic index with C-peptide, glucose area under the curve (AUC)/insulin AUC] and model-based [beta cell function and insulin secretion rate at 9 mM glucose] testing. Analysis was performed with non-linear least squares using the Software Architecture Analysis Method (SAAM) II software. SBCSGI was expressed in units of 10^-9 min^-1. Excluding rescue approach data analysis excluded all data following the initiation of rescue therapy at any time point, in order to avoid the confounding influence of the rescue therapy.|30 min. before and 0, 15, 30, 60, 90, 120, and 180 minutes following the start of the standard meal at Baseline and Week 26|The analysis population consisted of all randomized participants who received at least one dose of study treatment, had a baseline measurement or a post-randomization measurement for the beta-cell responsivity static component change from baseline at Week 26 analysis endpoint subsequent to at least one dose of study treatment.||SBCSGI (10^-9min^-1)||95% Confidence Interval|Least Squares Mean
859988|NCT02099110|Secondary|Percentage of Participants Achieving a Hemoglobin A1C of <7% (<53 mmol/Mol) (Raw Proportions): Excluding Rescue Approach|A1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%). Excluding recue approach data analysis excluded all data following the initiation of rescue therapy at any time point, in order to avoid the confounding influence of the rescue therapy.|Week 26|The analysis population consisted of all randomized participants who received at least one dose of study treatment, had a post-randomization measurement for the A1C change from baseline at Week 26 analysis endpoint subsequent to at least one dose of study treatment.||Percentage of participants|||Number
859989|NCT02099110|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 - Excluding Rescue Approach|Blood glucose was measured on a fasting basis after at least a 10-hour fast. This change from baseline reflects the Week 26 FPG minus the Week 0 FPG. Excluding recue approach data analysis excluded all data following the initiation of rescue therapy at any time point, in order to avoid the confounding influence of the rescue therapy.|Baseline and Week 26|The analysis population consisted of all randomized participants who received at least one dose of study treatment, had a baseline measurement or a post-randomization measurement for the FPG change from baseline at Week 26 analysis endpoint subsequent to at least one dose of study treatment.||mg/dL||95% Confidence Interval|Least Squares Mean
859990|NCT02099110|Secondary|Change From Baseline in Body Weight at Week 26: Excluding Rescue Approach|This change from baseline reflects the Week 26 body weight minus the Week 0 body weight. Excluding recue approach data analysis excluded all data following the initiation of rescue therapy at any time point, in order to avoid the confounding influence of the rescue therapy.|Baseline and Week 26|The analysis population consisted of all randomized participants who received at least one dose of study treatment, had a baseline measurement or a post-randomization measurement for the body weight change from baseline at Week 26 analysis endpoint subsequent to at least one dose of study treatment.||Kilograms||95% Confidence Interval|Least Squares Mean
859991|NCT02099110|Primary|Percentage of Participants Who Discontinued Study Treatment Due to an AE: Including Rescue Approach|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Including rescue approach data analysis included data following the initiation of rescue therapy.|Up to 52 weeks|The analysis population consists of all randomized participants who received at least 1 dose of study treatment.||Percentage of participants|||Number
859992|NCT02099110|Primary|Percentage of Participants Who Experienced an Adverse Event (AE): Including Rescue Approach|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Including rescue approach data analysis included data following the initiation of rescue therapy.|Up to 54 weeks|The analysis population consists of all randomized participants who received at least 1 dose of study treatment.||Percentage of participants|||Number
859993|NCT02099110|Primary|Change From Baseline in A1C at Week 26: Excluding Rescue Approach|A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 26 A1C minus the Week 0 A1C. Excluding recue approach data analysis excluded all data following the initiation of rescue therapy at any time point, in order to avoid the confounding influence of the rescue therapy.|Baseline and Week 26|The analysis population consisted of all randomized participants who received at least one dose of study treatment, had a baseline measurement or a post-randomization measurement for the A1C change from baseline at Week 26 analysis endpoint subsequent to at least one dose of study treatment.||Percentage||95% Confidence Interval|Least Squares Mean
859994|NCT01999920|Secondary|Change From Baseline on Adult Separation Anxiety - 27 Scale|Measure Description: (15 min) Adult Separation Anxiety - 27 Scale 27 items pertaining to adult separation anxiety, each self-rated on a four-point scale, 0=best, 3=worse. Minimum Total Score=0 (better); Maximum Total Score = 81 (worse)|Up to 12 weeks|||units on a scale||Standard Deviation|Mean
859995|NCT01999920|Secondary|Change From Baseline on Structured Clinical Interview for Separation Anxiety Disorder|The Structured Clinical Interview for Separation Anxiety Disorder was modified for DSM-5. The eight separation anxiety disorder criteria are rated for both childhood (rated at baseline only) and past week time frames, scored as 0 (not at all), 1 (sometimes), 2 (often) or ? (don’t recall). In keeping with the DSM-5 guidelines, endorsement of three or more of the eight criterion symptoms (symptoms rated as ‘2’ or ‘often’) is used as a threshold to determine categorical (yes/no) diagnosis of separation anxiety disorder. Scores on each of the eight items are also summed to produce a continuous measure of separation anxiety symptoms experienced during childhood and adulthood (range for each scale=0–16).|Baseline and week 12|||units on a scale||Standard Deviation|Mean
860000|NCT01999322|Secondary|Number of Premature Infusion Set Changes|"A premature infusion set change was defined as not being a routine change. This was defined as an infusion set changed at home due to suspicion of occlusion, leakage, unexplained hyperglycaemic episode, infusion site reaction, technical reason, or other. The change of infusion set at a site visit was considered a routine change unless an occlusion was actually suspected at the site."|During 6 weeks of treatment|||Episodes|||Number
860001|NCT01999322|Secondary|Number of Episodes of Possible Infusion Set Occlusions|Episodes of possible infusion set occlusions were defined as infusion sets changed due to suspicion of occlusion, leakage or unexplained hyperglycaemic episode. Possible occlusion excluded technical reasons. This endpoint was calculated from the recorded date/times of changes of infusion set combined with the subjects’ own assessment.|During 6 weeks of treatment|||Episodes|||Number
860002|NCT01999322|Secondary|Number of Unexplained Episodes of Hyperglycaemia (Confirmed by Self-measured Plasma Glucose (SMPG))|Unexplained hyperglycaemia was defined as a confirmed plasma glucose value ≥ 16.7 mmol/L (300 mg/dL) and was unexplained (i.e., no apparent medical, dietary, insulin dosage or pump failure reason)|During 6 weeks of treatment|||events|||Number
860003|NCT01999322|Primary|Number of Microscopically Confirmed Episodes of Infusion Set Occlusions|The number of microscopically confirmed episodes of infusion set occlusions during 6 weeks of treatment. Episodes of infusion set occlusions were confirmed by microscopic examination of the infusion sets at each routine weekly visit and infusion sets that had been changed prematurely because of leakage, unexplained hyperglycaemia or suspicion of occlusion (observation of a plug).|During 6 weeks of treatment|FAS: included all randomised subjects. In exceptional cases subjects could be excluded from the full analysis set. In such cases the reason for exclusion was to be justified and documented. Subjects in the full analysis set contribute to the evaluation “as randomised”.||Episodes|||Number
860004|NCT01994395|Secondary|Berg Balance Scale (BBS)|The BBS is a 14-item objective measure designed to assess static balance and fall risk in adult populations and is a well-accepted measure in the stroke literature. The functional activities that are assessed include sitting and standing balance during transfers, altered base of support, reaching, turning, eyes open and closed. Each item is scored from 0 to 4 points. The maximum score is 56 points. A score from 0 to 20 represents balance impairment, 21 to 40 represents acceptable balance, and 41-56 represents good balance. The minimal detectable change score for individuals with acute stroke is 6.9 points16 and 4.66 points in chronic stroke17.|Baseline Assessment (Visit 1), Mid Training Assessment (Visit 10), Post Training Assessment (Visit 18), 3 Month Post Training Assessment (3 Month Follow-up)|One subject dropped out at baseline screening, prior to assignment to any group. One subject from SMA group and 2 from impairment based therapy group dropped due to scheduling conflicts prior to starting any training.||units on a scale, each item scored 0-4||Standard Deviation|Mean
860005|NCT01994395|Secondary|Change in 6 Minute Walk Test From Baseline in Distance (6MWT)|"The 6 Minute Walk Test (6MWT) is a test of endurance, by measuring the distance a subject can walk indoors on a flat, hard surface in a period of 6 minutes, using assistive devices, as necessary.The distance is measured with a measuring wheel. The instructions are Walk covering as much ground as you can in 6 min. You can stop to sit or stand if needed, but time will keep running. The change in the distance walked in the 6-minute walk can be used to evaluate the efficacy of an exercise-training program or to trace the natural history of change in exercise capacity over time. The 6MWT is measured in meters."|Baseline Assessment (Visit 1), Mid Training Assessment (Visit 10), Post Training Assessment (Visit 18), 3 Month Post Training Assessment (3 Month Follow-up)|One subject from SMA group and 2 from impairment based therapy group dropped due to scheduling conflicts prior to starting any training.||units on a scale||Standard Deviation|Mean
860006|NCT01994395|Secondary|Participants Receiving Transcranial Magnetic Stimulation (TMS)|To compare the effect of training on the connections between the brain and leg muscles (descending corticomotor drive) using a non-invasive brain stimulation called transcranial magnetic stimulation (TMS). TMS is a safe, non-invasive, painless method of brain stimulation that has been widely used to study the physiology of the representations of muscles in the motor cortex in healthy and neurologically disordered individuals13. Very short duration (< 1 ms) magnetic pulses are applied via an insulated wire coil placed on the intact scalp overlaying the motor cortical area projecting to a target muscle. Each pulse induces a motor evoked potential (MEP) in a target muscle that can be readily monitored by recording Electromyogram (EMG) from that muscle. A figure-of-eight or double cone coil is typically used to deliver focal magnetic pulses to a number of scalp sites over the cortical area representing a muscle of interest.|Session 0 (initial visit);Session 20 (between 6-8 weeks)|One subject dropped before being assigned to a group. One subject from SMA group and 2 from impairment based therapy group dropped due to scheduling conflicts prior to starting any training.||Participants|||Count of Participants
860007|NCT01994395|Secondary|Patient Health Questionnaire-9 (PHQ-9)|PHQ-9 is a 9-item self-report questionnaire designed to diagnose both the presence of depressive symptoms as well as to characterize the severity of depression. A single question rates how difficult problems have made it to do work, take care of things at home or get along with other people using a 4 level scale (not difficult at all to extremely difficult). Each item is scored from 0-3; total scores may be 0-27, with higher scores representing increased severity of depression.|Baseline Assessment (Visit 1), Mid Training Assessment (Visit 10), Post Training Assessment (Visit 18), 3 Month Post Training Assessment (3 Month Follow-up)|One subject dropped out at baseline screening, prior to assignment to any group. One subject from SMA group and 2 from impairment based therapy group dropped due to scheduling conflicts prior to starting any training.||units on a scale||Standard Deviation|Mean
860008|NCT01994395|Secondary|The Modified Falls Efficacy Scale (mFES)|14 item questionnaire assessing individuals' confidence in their ability to perform tasks without falling. Individuals rate their confidence from 0 (not confident at all) to 100 (completely confident).|Baseline Assessment (Visit 1), Mid Training Assessment (Visit 10), Post Training Assessment (Visit 18), 3 Month Post Training Assessment (3 Month Follow-up)|One subject dropped out at baseline screening, prior to assignment to any group. One subject from SMA group and 2 from impairment based therapy group dropped due to scheduling conflicts prior to starting any training.||units on a scale||Standard Deviation|Mean
860178|NCT01454076|Secondary|Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities||Cycle 1 Day 1 up to 30 days after last dose of study drug (Arm 1 and 5: Cycle 19 Day 45; Arm 2: Cycle 7 Day 45; Arm 3: Cycle 22 Day 45; Arm 4: Cycle 25 Day 45|The safety population included all participants who received at least one dose of any study drug.||participants|||Number
860009|NCT01994395|Secondary|Stroke Specific Quality of Life Scale (SS-QOL)|A 49 item assessment grouped into 12 domains of health-related quality of life in stroke survivors; including areas of mobility, energy, upper extremity function, work and productivity, mood, self-care, social roles, family roles, vision, language, thinking, personality. Each individual domain consists of 3 to 10 items that are averaged to generate an overall score, each item is rated on a 5- point Likert scale, with a minimum value of 1 (meaning the worst outcome) and a maximum value of 5 (meaning the best outcome). Domains scores (non-weighted average of item scores) and a summary score (non-weighted average of all 12 domain scores) are computed. Summary scores range from 49-245, with higher scores indicating better functioning.|Baseline Assessment (Visit 1), Mid Training Assessment (Visit 10), Post Training Assessment (Visit 18), 3 Month Post Training Assessment (3 Month Follow-up)|One subject dropped out at baseline screening, prior to assignment to any group. One subject from SMA group and 2 from impairment based therapy group dropped due to scheduling conflicts prior to starting any training.||units on a scale||Standard Deviation|Mean
860010|NCT01994395|Secondary|Numeric Pain Rating Scale (NPRS)|The NPRS is an 11-point scale from 0-10 where patients verbally select a value that is most in line with the intensity of pain that they have experienced in the last 24 hours from 0 (no pain) to 10 (the most intense pain imaginable).|Baseline Assessment (Visit 1), Mid Training Assessment (Visit 10), Post Training Assessment (Visit 18), 3 Month Post Training Assessment (3 Month Follow-up)|One subject dropped out at baseline screening, prior to assignment to any group. One subject from SMA group and 2 from impairment based therapy group dropped due to scheduling conflicts prior to starting any training.||units on a scale||Standard Deviation|Mean
860011|NCT01994395|Secondary|Activities-Specific Balance Confidence Scale (ABC)|ABC is a 16-item self-report measure in which patients rate their balance confidence in performing various ambulatory activities without falling. Items are rated on a scale ranging from 0-100, with zero representing no confidence and 100 representing complete confidence.|Baseline Assessment (Visit 1), Mid Training Assessment (Visit 10), Post Training Assessment (Visit 18), 3 Month Post Training Assessment (3 Month Follow-up)|One subject from SMA group and 2 from impairment based therapy group dropped due to scheduling conflicts prior to starting any training.||units on a scale||Standard Deviation|Mean
860012|NCT01994395|Primary|Change in 10 Meter Walk Test From Baseline in Gait Speed|"Measure of self selected and fast walking speeds by measuring the time it takes an individual to walk 10 meters. The test is performed using a flying start, patient walks 10 meters (33 ft) and the time is measured when the leading foot crosses the start line and the finish line. The instructions are: Please walk this distance at your normal pace when I say go. and repeated Please walk this distance as fast as you can safely when I say go."|Baseline Assessment (Visit 1), Mid Training Assessment (Visit 10), Post Training Assessment (Visit 18), 3 Month Post Training Assessment (3 Month Follow-up)|One subject from SMA group and 2 from impairment based therapy group dropped due to scheduling conflicts prior to starting any training.||meters per second||Standard Deviation|Mean
860013|NCT01945021|Secondary|Change From Baseline Scores on the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13|The QLQ-LC13 consisted of 1 multi-item scale and 9 single items that assessed specific symptoms (dyspnea, cough, hemoptysis, and site-specific pain), side effects (sore mouth, dysphagia, neuropathy, and alopecia), and pain medication use. Negative change from baseline scores indicated an improvement in symptoms, decreased functioning, or decreased global QOL, while positive change from baseline scores indicated an improvement in functioning, improvement in global QOL, or a worsening of symptoms. Scores on each sub-scale range from 0 - 100. A clinically meaningful change was defined as a >/= 10-point change in mean scores. Changes were described as statistically significant if the 95% CI for the change did not include 0.|From the date of informed consent every 8 weeks or 12 weeks until cycle 8|Number of participants that had both a baseline assessment and an assessment at cycle 8||units on a scale||Standard Deviation|Mean
860014|NCT01945021|Secondary|Change From Baseline Scores on the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QOL) Questionnaire Core 30 (QLQ-C30)|The QLQ-C30 consists of 30 questions which are incorporated into 5 functional domains (physical, role, cognitive, emotional, and social domains); a global health status/global QOL scale; 3 symptom scales (fatigue, pain, nausea and vomiting scales); and 6 single items that assess the additional symptoms (dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea) and the perceived financial burden of treatment. Scores for each sub-scale range from 0 to 100. Negative change from baseline scores indicated an improvement in symptoms, decreased functioning, or decreased global QOL, while positive change from baseline scores indicated an improvement in functioning, improvement in global QOL, or a worsening of symptoms. A clinically meaningful change was defined as a >/= 10-point change in mean scores. Changes were described as statistically significant if the 95% CI for the change did not include 0.|From the date of informed consent every 8 weeks or 12 weeks until cycle 8|Number of participants that had both a baseline assessment and an assessment at cycle 8||units on a scale||Standard Deviation|Mean
860015|NCT01945021|Secondary|Number of Patients With a Shift of Chemistry Laboratory Results From Grade </= 2 to Grade 3 or Grade 4|A summary of the number of patients in the safety population with available laboratory data whose chemistry laboratory results shifted from a baseline value of Grade </=2 to a post-baseline result of Grade 3 or Grade 4|From time of baseline screening test every 4, 8, or 12 weeks until 28 days from last dose of study treatment|||participants|||Number
860016|NCT01945021|Secondary|Number of Patients With a Shift in Hematology Laboratory Results From Grade </=2 to Grade 3 or Grade 4|A summary of the number of patients in the safety population with available laboratory data whose hematology laboratory results shifted from a baseline value of Grade </=2 to a post-baseline result of Grade 3 or Grade 4|From time of baseline screening test every 4, 8, or 12 weeks until 28 days from last dose of study treatment|||participants|||Number
860017|NCT01945021|Secondary|Type, Incidence, Severity, Seriousness and Relationship to Study Medications of Adverse Events (AE) and Any Laboratory Abnormalities|Incidence of patients experiencing a treatment emergent adverse events were summarized by type, incidence, severity, seriousness and relationship to study medication.|From the date of signed informed consent, then a minimum of every 4 weeks until 32 weeks, then a minimum of every 8 weeks, or until 4 weeks after last dose of treatment|||percentage of patients|||Number
860365|NCT00781937|Secondary|Change From Baseline in Blood Pressure||Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)||mmHg||Standard Error|Least Squares Mean
860018|NCT01945021|Secondary|Overall Survival||Assessed from date of date of the first dose of crizotinib until the date of death from any cause, assessed up to 6 months after the last subject is enrolled on the trial|OS is defined as the time from the date of the first dose of crizotinib to the date of death due to any cause. For patients still alive at the time of analysis, the OS time will be censored on the last date the patients were known to be alive.||months||95% Confidence Interval|Median
860019|NCT01945021|Secondary|Progression Free Survival Assessed by Independent Radiology Review|Progression Free Survival is defined as the time from the date of the first dose of crizotinib to first documentation of objective disease progression or to death on study due to any cause, whichever occurs first. Patients who had neither progression nor death without objective progression were censored at the time of data cut off.|From the date of first dose of crizotinib every 8 weeks or 12 weeks until the first documentation of objective disease progression or death|||months||95% Confidence Interval|Median
860020|NCT01945021|Secondary|Disease Control Rate at 8 Weeks by Independent Radiology Review|The Disease Control Rate at 8 weeks is defined as the number of patients with a confirmed CR, confirmed PR, or SD at 8 weeks, respectively, according to RECIST v1.1 (as determined by IRR), relative to the total population of response evaluable patients.|Measured once at 8 weeks after the start of study treatment|||participants|||Number
860021|NCT01945021|Secondary|Time to First Response|Time to response is defined as the time from the date of first dose to first documentation of objective tumor response (CR or PR), as assessed by Independent Radiology Review, that is subsequently confirmed. For patients proceeding from PR to CR, the onset of PR is taken as the onset of response.|From date of first dose of crizotinib every 8 weeks or 12 weeks until first documentation of objective response is observed, until 6 months after the last subject is enrolled on the trial|Analysis is based on 88 patients who achieved an objective response as assessed by Independent Radiology Review||months||Full Range|Median
860022|NCT01945021|Secondary|Duration of Response by Independent Review|The time from the first documentation of objective tumor response (CR or PR) according to Independent Review and that was subsequently confirmed to the first documentation of objective disease progression or to death due to any cause, whichever occurs first. It was calculated for the response evaluable population in the subgroup of patients with a confirmed objective response and who had a subsequent event of progression or death without progression. Patients who did not meet these criteria were censored on the date of the last on-study tumor assessment.|Every 8 or 12 weeks until 6 months after the last patient was enrolled in the trial|Duration of response was calculated for the response evaluable population in the subgroup of patients with a confirmed objective response by Independent Review and who either subsequently had objective progression or died, whichever occurred first.||months||Standard Deviation|Mean
860023|NCT01945021|Primary|Independent Radiology Reviewed Overall Objective Response (ORR)|Overall Objective Response (ORR) was defined as the number of patients with a best overall response of confirmed Complete Response or confirmed Partial Response according to RECIST v1.1 (as determined by Independent Radiology Review [IRR]), relative to the total population of response-evaluable patients (n=127). Confirmed responses were those that persisted on repeat imaging at least 4 weeks after the initial documentation of response.|Starting from the first dose study treatment until the first documented CR or PR.|||participants|||Number
860024|NCT01752712|Secondary|Brief Psychiatric Rating Scale (BPRS) Psychosis Score|"The psychosis score is calculated by adding the scores for scales #4 Conceptual Disorganization, #11 Suspiciousness, #12 Hallucinatory Behavior, and #15 Unusual Thought Content. Each scale ranges from 1=Not Present to 7=Very Severe. The minimum psychosis score is 4 and the maximum psychosis score is 28. A higher score indicates a more severe psychosis rating."|Every 4 weeks during the treatment phase, plus follow-up week 36|Only participants who were enrolled in the study and had completed a BPRS assessment were analyzed at each study time point.||units on a scale||Standard Deviation|Mean
860025|NCT01752712|Secondary|Brief Psychiatric Rating Scale (BPRS) Total Score|"The total BPRS score is calculated by adding the scores for scales #1-#18. Each scale ranges from 1=Not Present to 7=Very Severe. Total scores range from a minimum score of 18 to a maximum score of 126. A higher total score indicates a more severe psychiatric symptom rating."|Every 4 weeks during the treatment phase, plus follow-up week 36|Only participants who were enrolled in the study and had completed a BPRS assessment were analyzed at each study time point.||units on a scale||Standard Deviation|Mean
860026|NCT01752712|Secondary|Schedule for Assessment of Negative Symptoms (SANS) Total Score|SANS total score range = 0-85. Higher scores indicate more severe negative symptoms.|Every 4 weeks during the treatment phase, plus follow-up week 36|Only participants who were enrolled in the study and had completed a SANS assessment were analyzed at each study time point.||units on a scale||Standard Deviation|Mean
860027|NCT01752712|Secondary|Asocial Belief Scale (ABS) Total Score|Determine if CBSST + oxytocin compared to CBSST + placebo is associated with asocial beliefs. The total ABS score is calculated by adding the scores for items #1-#15. Each scale is provided a True/False response, with True responses equaling 1 point and False responses equaling 0 points. In calculating the ABS total score, four of the 15 items of the ABS were reverse scored. A lower total score indicates more severe asocial beliefs.|Treatment weeks 0, 12, and 24, plus follow-up week 36|Only participants who were enrolled in the study and had completed a ABS assessment were analyzed at each study time point.||units on a scale||Standard Deviation|Mean
860028|NCT01752712|Secondary|Defeatist Performance Attitudes Scale (DPAS) Total Score|"Determine if CBSST + oxytocin compared to CBSST + placebo is associated with defeatist performance beliefs. The total DPAS score is calculated by adding the scores for scales #1-#18. Each scale ranges from 1=Agree Totally to 7=Disagree Totally. Total scores range from a minimum score of 18 to a maximum score of 126. Reverse scoring was applied to make higher scores indicate a stronger defeatist attitude."|Treatment weeks 0, 12, and 24, plus follow-up week 36|Only participants who were enrolled in the study and had completed a DPAS assessment were analyzed at each study time point.||units on a scale||Standard Deviation|Mean
860029|NCT01752712|Primary|Birchwood Social Function Scale (BSFS) Total Score|Determine if CBSST + oxytocin compared to CBSST + placebo is associated with improved social function. The total BSFS score is calculated by adding the total scores from each of the 7 sections, with a maximum total score of 247. A lower total score indicates a lower social function rating.|Treatment weeks 0, 12, and 24, plus follow-up week 36|Only participants who were enrolled in the study and had completed a BSFS assessment were analyzed at each study time point.||units on a scale||Standard Deviation|Mean
860030|NCT01740427|Secondary|Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs; All Causalities)|An AE is any untoward medical occurrence in a clinical investigation patient administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. An SAE is any untoward medical occurrence at any dose that results in death; is life-threatening; requires hospitalization; results in persistent or significant disability or in congenital anomaly/birth defect. Severity will be graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0.|From the participant randomization up to 28 days after last dose of study drug, up to 2.5 years|AT population = ITT population because all the participants randomized were treated with study drugs per study design.||Percentage of Participants|||Number
860031|NCT01740427|Secondary|Change From Baseline Between Treatment Comparison in Functional Assessment of Cancer Therapy -Breast (FACT-B)|FACT is a modular approach to assess participant health-related quality of life using a ‘core’ set of questions (FACT-G) as well as a cancer site-specific module. The FACT-G is a 27-item compilation of general questions divided into 4 domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. The FACT-B consisted of the FACT-G (27-item) and a breast-specific module: a 10-item instrument designed to assess participant concerns relating to breast cancer. For all questions, participants were asked to respond to a five-level scale where 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much. FACT-B total score = Physical Well-Being + Social/Family Well-Being + Emotional Well-Being + Functional Well-Being + Breast Cancer Subscale. As each of the items ranges from 0-4, the range of possible scores is 0-144, with 0 being the worst possible score and 144 the best.|From Baseline up to 2.5 years|Patient Reported Outcome (PRO) Analysis Set is a subset of ITT participants, who had both baseline and at least one follow-up PRO assessment.||Units on a scale||95% Confidence Interval|Mean
860032|NCT01740427|Secondary|Change From Baseline Between Treatment Comparison in Euro Quality of Life (EQ-5D) Index|The EuroQol EQ-5D is a 6-item instrument designed to assess health status in terms of a single index value or utility score. It contains 5 descriptors of current health state (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression) with each dimension having 3 levels of function (1=no problem, 2=some problem, and 3=extreme problem). The scores on the 5 descriptors are summarized to create a single summary score. An overall utility score is calculated based on these domains, with a range score from 0 (worse health scenario) to a maximum of 1.0 (best health scenario).|From Baseline up to 2.5 years|Patient Reported Outcome (PRO) Analysis Set is a subset of ITT participants, who had both baseline and at least one follow-up PRO assessment.||Units on a scale||95% Confidence Interval|Mean
860033|NCT01740427|Secondary|Observed Plasma Trough Concentration (Ctrough) at Steady-State|Summary of Plasma Palbociclib Within-Patient Mean Steady-State Trough Concentrations.|0 hour (predose) on Day 14 of cycles 1 and 2|Pharmacokinetic analysis set was a subset of AT participants, who were treated with Palbociclib and had at least one measured plasma concentration.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
860034|NCT01740427|Secondary|Corrected QT Interval (QTc)|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and sent to a central laboratory for blinded manual adjudication. The average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR), by Bazette's formula (QTcB = QT divided by square root of RR) and corrected QT interval according to study-specific criteria (QTcS). Percentage of participants with post-baseline maximum absolute values and maximum increase from baseline were summarized for the safety analysis population.|For safety monitoring triplicate ECGs were obtained at 0 hour (pre-dose) on Day 1 of Cycle 1, Day 14 of Cycles 1 and Cycle 2, then on Day 1 of Cycles 4, 7, and 10. ECGs beyond Cycle 10 were performed as clinically indicated|The AT population or safety analysis set included all participants who received at least 1 dose of study medication, with treatment assignments designated according to actual study treatment received.||Percentage of participants|||Number
860035|NCT01740427|Secondary|Corrected QT Interval (QTc) Time-matched Change From Baseline on Cycle 1 Day 14|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and sent to a central laboratory for blinded manual adjudication. The average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR), by Bazette's formula (QTcB = QT divided by square root of RR) and corrected QT interval according to study-specific criteria (QTcS). Time-matched change from baseline values were reported for QTc analysis population.|Time-matched triplicate ECGs were collected at 0 (predose), 2, 4, 6 and 8 hours on Day 0 and on Cycle1 Day14|QTc analysis set is a subset of as treated (AT) population who were in Group 1; their QTc was used to study the effect of palbociclib on QT interval via serial triplicate ECGs with PK draws; and who had ≥ 1 pair of time-matched Day 0 and palbociclib postdose (Cycle1 Day14) measurements.||msec||90% Confidence Interval|Least Squares Mean
860036|NCT01740427|Secondary|Tumor Tissue Biomarkers, Including Genes (eg, Copy Numbers of CCND1, CDKN2A), Proteins (eg, Ki67, pRb), and RNA Expression (eg, cdk4, cdk6): Protein Biomarker Analyses by Using Immunohistochemistry Are Presented|"PFS survival by biomarker status by Investigator assessment. Progression is defined using RECIST v1.1, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Positive is defined as H-Score ≥1 and negative as H-Score <1. H-Score is calculated as the sum of the % of cells at each level of staining intensity (0, 1+, 2+, and 3+) multiplied by the staining intensity value: H-Score = (% at 0)*0 + (% at 1+)*1 + (% at 2+)*2 + (% at 3+)*3. H-Score values range from 0 to 300.
ER stands for estrogen receptor and Rb stands for retinoblastoma susceptibility gene product."|From randomization until end of treatment (up to approximately 24 Months)|ITT population or full analysis set included all participants who were randomized, with study medication, regardless of whether participants received study medication or received a different drug from that to which they were randomized.||Months||95% Confidence Interval|Median
860055|NCT01732822|Other Pre-specified|CV-related Hospitalization|Participants with hospitalization associated with CV death, hospitalization due to MI, ischemic stroke, lower extremity revascularization, major amputation due to PAD, transient ischemic attack (TIA), coronary revascularization or unstable angina. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, death date)|From randomization to PACD, an average of 2.5 years|The population was the full analysis set, which included all randomized patients||Participant|||Number
860037|NCT01740427|Secondary|Disease Control (DC)/Clinical Benefit Response (CBR)|DC is defined as the overall CR, PR, or stable disease (SD) ≥24 weeks according to the RECIST version 1.1. Disease Control Rate (DCR) is defined as the patients with CR, PR, or SD ≥24 weeks relative to all randomized participants. Participants who do not have on-study radiographic tumor reevaluation, who received anti-tumor treatment, a best response of SD≥24 weeks, or who died, progressed,or dropped out for any reason prior to achieving reaching a CR or PR and a best response of SD≥24 weeks was counted as non-responders in DCR. Per RECIST v1.1, CR: Complete disappearance of target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis <10mm). PR: ≥30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions. SD: neither sufficient shrinkage nor increase to qualify for disease progression|From randomization until end of treatment (up to approximately 2.5 years)|ITT population or full analysis set included all participants who were randomized, with study medication, regardless of whether participants received study medication or received a different drug from that to which they were randomized.||Percentage of participants||95% Confidence Interval|Number
860038|NCT01740427|Secondary|Duration of Response (DR)|DR is defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of disease progression or to death due to any cause, whichever occurs first. If tumor progression data included more than 1 date, the first date will be used. DR was calculated as [the date response ended (i.e. date of PD or death) – first CR or PR date + 1)]/30.4. DR would only be calculated for the subgroup of patients with an objective tumor response. Per RECIST v1.1, CR: Complete disappearance of target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis <10mm). PR: ≥30% decrease under baseline of the sum of diameters of all target measurable lesions.The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions. Stable Disease: neither sufficient shrinkage nor increase to qualify for disease progression.|From randomization until end of treatment (up to approximately 2.5 years)|Patients who had tumor response with CR or PR during study. A total of 206 and 85 patients had objective response in the palbociclib plus letrozole and placebo plus letrozole arms, respectively.||Months||95% Confidence Interval|Median
860039|NCT01740427|Secondary|Objective Response: Patients With Measurable Disease at Baseline as Assessed by the Investigator|The OR is defined as the overall CR or PR according to the RECIST v1.1. ORR is defined as proportion of patients with CR or PR relative to all randomized patients with measurable disease at baseline. Patients who do not have on-study radiographic tumor re-evaluation, who received anti-tumor treatment, or who died, progressed/ dropped out for any reason prior to reaching a CR or PR were counted as non-responders in the assessment of ORR. Per RECIST v1.1, CR: Complete disappearance of target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis <10mm). PR: ≥30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions. Stable Disease: neither sufficient shrinkage nor increase to qualify for disease progression.|From randomization until end of treatment (up to approximately 2.5 years)|Patients who had measurable disease at baseline. A total of 338 and 171 patients had measurable disease at baseline in the palbociclib plus letrozole and placebo plus letrozole arms, respectively.||Percentage of participants||95% Confidence Interval|Number
860040|NCT01740427|Secondary|Objective Response as Assessed by the Investigator|Objective Response (OR) is defined as the overall complete response (CR) or partial response (PR) according to the RECIST v1.1. Objective Response Rate (ORR) is defined as proportion of patients with CR or PR relative to all randomized patients with measurable disease at baseline. Patients who do not have on-study radiographic tumor re-evaluation, who received anti-tumor treatment, or who died, progressed/ dropped out for any reason prior to reaching a CR or PR were counted as non-responders in the assessment of ORR. Per RECIST v1.1, CR: Complete disappearance of target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis <10mm). PR: ≥30% decrease under baseline of the sum of diameters of all target measurable lesions.The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions. Stable Disease: neither sufficient shrinkage nor increase to qualify for disease progression.|From randomization until end of treatment (up to approximately 2.5 years)|ITT population or full analysis set included all participants who were randomized, with study medication, regardless of whether participants received study medication or received a different drug from that to which they were randomized.||Percentage of participants||95% Confidence Interval|Number
860041|NCT01740427|Primary|Progression-Free Survival (PFS) as Assessed by the Investigator.|PFS is defined as the time from the date of randomization to the date of the first documentation of objective tumor progression as per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) or death due to any cause in the absence of documented PD, whichever occurs first. If tumor progression data include more than 1 date, the first date will be used. PFS (in months) will be calculated as (first event date − randomization date +1)/30.4. Progression is defined using RECIST v1.1, as a 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm, or unequivocal progression of pre-existing non-target lesions, or the appearance of new lesions.|From randomization date to date of first documentation of progression OR death (up to approximately 2.5 years)|ITT population or full analysis set included all participants who were randomized, with study medication, regardless of whether participants received study medication or received a different drug from that to which they were randomized.||Months||95% Confidence Interval|Median
860042|NCT01737268|Secondary|Number of Participants With Adverse Events|An adverse event (AE) is defined as any undesirable or unintended sign (including abnormal laboratory test values), symptom, or disease occurring while the study drug was administered, regardless of whether or not there was a causal relationship with the study drug. A serious AE is defined as a an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, re quire d or prolonged hospitalization or was considered medically important.|From first dose of study drug up to week 52 (52 weeks)|Safely Analysis Set (SAF), which included participants who received at least one dose of study drug.||Participants|||Count of Participants
860043|NCT01737268|Secondary|CGI-BP-C: Mania|The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score.|Week 52 (or the time of last assessment for participants who discontinued earlier)|FAS population; last assessment value is used for participants who discontinued before week 52.||units on a scale||Standard Deviation|Mean
860044|NCT01737268|Secondary|CGI-BP-C: Depression|The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score.|Week 52 (or the time of last assessment for participants who discontinued earlier)|FAS population; last assessment value is used for participants who discontinued before week 52.||units on a scale||Standard Deviation|Mean
860045|NCT01737268|Secondary|Clinical Global Impression-Bipolar-Change (CGI-BP-C): Overall Bipolar Illness|The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score.|Week 52 (or the time of last assessment for participants who discontinued earlier)|FAS population; last assessment value is used for participants who discontinued before week 52.||units on a scale||Standard Deviation|Mean
860046|NCT01737268|Secondary|Change From Baseline to Last Assessment in Treatment Period in Hamilton Depression Scale (HAM-D17) in CGI-BP-S: Mania|The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from with the scale from 1 (Normal, not ill) to 7 (very severely ill).|Baseline and and week 52 (or the time of last assessment for participants who discontinued earlier)|FAS population; last assessment value is used for participants who discontinued before week 52.||units on a scale||Standard Deviation|Mean
860047|NCT01737268|Secondary|Change From Baseline to Last Assessment in Treatment Period in CGI-BP-S: Depression|The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from with the scale from 1 (Normal, not ill) to 7 (very severely ill).|Baseline and week 52 (or the time of last assessment for participants who discontinued earlier)|FAS population; last assessment value is used for participants who discontinued before week 52.||units on a scale||Standard Deviation|Mean
860048|NCT01737268|Secondary|Change From Baseline to Last Assessment in Treatment Period in Clinical Global Impression-Bipolar-Severity of Illness (CGI-BP-S): Overall Bipolar Illness|The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from with the scale from 1 (Normal, not ill) to 7 (very severely ill).|Baseline and week 52 (or the time of last assessment for participants who discontinued earlier)|FAS population; last assessment value is used for participants who discontinued before week 52.||units on a scale||Standard Deviation|Mean
860049|NCT01737268|Secondary|Change From Baseline to Last Assessment in Treatment Period in Hamilton Depression Scale (HAM-D17)|The HAM-D17 is a clinician-rated 17-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 52 with lower scores indicating less depressive symptoms.|Baseline and week 52 (or the time of last assessment for participants who discontinued earlier)|FAS population; last assessment value is used for participants who discontinued before week 52.||units on a scale||Standard Deviation|Mean
860050|NCT01737268|Primary|Change From Baseline to Last Assessment in Treatment Period in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms.|Baseline and week 52 (or the time of last assessment for participants who discontinued earlier)|FAS population; last assessment value is used for participants who discontinued before week 52.||units on a scale||Standard Deviation|Mean
860051|NCT01732822|Other Pre-specified|Premature Permanent Discontinuation of Study Drug Due to Any Bleeding Event|Participants with a permanent discontinuation of study drug due to any bleeding event. If no event, censoring occurs at the minimum of (last endpoint assessment date, death date, 7 days after last dose of study drug)|From the date of first dose and up to and including 7 days following the date of last dose of study drug|The population was the saftey analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or clopidogrel and for whom post-dose data are available||Participant|||Number
860052|NCT01732822|Other Pre-specified|PLATO Major Bleeding Events|Participants with PLATO major bleeding event. If no event, censoring occurs at the minimum of (last endpoint assessment date, death date, 7 days after last dose of study drug)|From the date of first dose and up to and including 7 days following the date of last dose of study drug|The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or clopidogrel and for whom post-dose data are available||Participant|||Number
860053|NCT01732822|Other Pre-specified|TIMI Major or Minor Bleeding Events|Participants with TIMI major or minor bleeding event. If no event, censoring occurs at the minimum of (last endpoint assessment date, death date, 7 days after last dose of study drug)|From the date of first dose and up to and including 7 days following the date of last dose of study drug|The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or clopidogrel and for whom post-dose data are available||Participant|||Number
860054|NCT01732822|Other Pre-specified|TIMI Major Bleeding Events|Participants with TIMI major bleeding event. If no event, censoring occurs at the minimum of (last endpoint assessment date, death date, 7 days after last dose of study drug)|From the date of first dose and up to and including 7 days following the date of last dose of study drug|The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or clopidogrel and for whom post-dose data are available||Participant|||Number
860058|NCT01732822|Other Pre-specified|Change in ABI/TBI From Baseline|"Change in ankle brachial index (ABI) / toe brachial index (TBI).
Ankle brachial index (ABI) is the ratio of blood pressures from the ankle and arm and is used for diagnosing peripheral arterial occlusive disease (PAOD):
Normal: 1 to 1.29 Borderline: 0.91 to 0.99 Mild PAOD: 0.71 to 0.90 Medium severe PAOD: 0.41 to 0.7 Severe PAOD: <0.4
Toe brachial index (TBI) is the ratio between the toe pressure and the higher brachial pressure, used for diagnosing PAOD when the ABI cannot be used:
Normal: >0.7 Mild: 0.5-0.7 Moderate: 0.35-0.5 Moderate-Severe: <0.35 and toe pressure 40 mmHg Severe: <0.35 and toe pressure < 30 mmHg"|From randomization to PACD, an average of 2.5 years|The population was the full analysis set, which included all randomized patients||Change in ABI/TBI||Standard Deviation|Mean
860059|NCT01732822|Other Pre-specified|Changes in Rutherford Classification|"Progression of the clinical/symptomatic status of the limb by changes in Rutherford classification.
Category 0 – Asymptomatic Category 1 – Mild claudication Category 2 – Moderate claudication – The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.
Category 3 – Severe claudication Category 4 – Rest pain Category 5 – Ischemic ulceration not exceeding ulcer of the digits of the foot Category 6 – Severe ischemic ulcers or frank gangrene"|From randomization to PACD, an average of 2.5 years|The population was the full analysis set, which included all randomized patients||Participant|||Number
860060|NCT01732822|Other Pre-specified|Changes in Fontaine Stage|"Progression of the clinical/symptomatic status of the limb by changes in Fontaine stage.
Stage I – Asymptomatic Stage IIa – Intermittent claudication after more than 200 meters of pain free walking Stage IIb – Intermittent claudication after less than 200 meters of walking Stage III – Rest pain Stage IV – Ischemic ulcers or gangrene"|From randomization to PACD, an average of 2.5 years|The population was the full analysis set, which included all randomized patients||Participant|||Number
860061|NCT01732822|Other Pre-specified|Non-CV Death|Participants with non-CV death. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, CV death)|From randomization to PACD, an average of 2.5 years|The population was the full analysis set, which included all randomized patients||Participant|||Number
860062|NCT01732822|Other Pre-specified|Net Clinical Benefit (Composite of All-cause Mortality/MI/Ischemic Stroke/ALI/Major Amputation/TIMI Major Bleeding)|Participants with all-cause death, MI, ischemic stroke, ALI, major amputation or Thrombolysis in Myocardial Infarction (TIMI) major bleeding. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date)|From randomization to PACD, an average of 2.5 years|The population was the full analysis set, which included all randomized patients||Participant|||Number
860063|NCT01732822|Other Pre-specified|Net Clinical Benefit (Composite of All-cause Mortality/MI/Ischemic Stroke/ALI/Major Amputation/Fatal Bleeding/Intracranial Bleeding)|Participants with all-cause death, MI, ischemic stroke, ALI, major amputation, fatal bleeding or intracranial bleeding. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date)|From randomization to PACD, an average of 2.5 years|The population was the full analysis set, which included all randomized patients||Participant|||Number
860064|NCT01732822|Other Pre-specified|Net Clinical Benefit (Composite of All-cause Mortality/MI/Ischemic Stroke/Fatal Bleeding/Intracranial Bleeding)|Participants with all-cause death, MI, ischemic stroke, fatal bleeding or intracranial bleeding. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date)|From randomization to PACD, an average of 2.5 years|The population was the full analysis set, which included all randomized patients||Participant|||Number
860065|NCT01732822|Other Pre-specified|Net Clinical Benefit (Composite of CV Death/MI/Ischemic Stroke/Fatal Bleeding/Intracranial Bleeding)|Participants with CV death, MI, ischemic stroke, fatal bleeding or intracranial bleeding. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, non-CV death date)|From randomization to PACD, an average of 2.5 years|The population was the full analysis set, which included all randomized patients||Participant|||Number
860066|NCT01732822|Secondary|Any Revascularisation (Coronary, Peripheral [Limb, Mesenteric, Renal, Carotid and Other])|Participants with any revascularization. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, death date)|From randomization to PACD, an average of 2.5 years|The population was the full analysis set, which included all randomized patients||Participant|||Number
860067|NCT01732822|Secondary|Lower Extremity Revascularization|Participants with lower extremity revascularization (LER). If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, death date)|From randomization to PACD, an average of 2.5 years|The population was the full analysis set, which included all randomized patients||Participant|||Number
860068|NCT01732822|Secondary|ALI|Participants with ALI. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, death date)|From randomization to PACD, an average of 2.5 years|The population was the full analysis set, which included all randomized patients||Participant|||Number
860069|NCT01732822|Secondary|Composite of CV Death, MI, and All-cause Stroke (Ischemic or Hemorrhagic)|Participants with CV death, MI or all-cause stroke. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, non-CV death date)|From randomization to PACD, an average of 2.5 years|The population was the full analysis set, which included all randomized patients||Participant|||Number
860070|NCT01732822|Secondary|All-cause Mortality|Participants with all-cause death. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date)|From randomization to PACD, an average of 2.5 years|The population was the full analysis set, which included all randomized patients||Participant|||Number
860071|NCT01732822|Secondary|MI|Participants with MI. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, death date)|From randomization to PACD, an average of 2.5 years|The population was the full analysis set, which included all randomized patients||Participant|||Number
860072|NCT01732822|Secondary|CV Death|Participants with CV death. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, non-CV death date)|From randomization to PACD, an average of 2.5 years|The population was the full analysis set, which included all randomized patients||Participant|||Number
860073|NCT01732822|Secondary|Composite of CV Death, MI, Ischemic Stroke, and ALI|Participants with CV death, MI, ischemic stroke or acute limb ischemia (ALI). If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, non-CV death date)|From randomization to PACD, an average of 2.5 years|The population was the full analysis set, which included all randomized patients||Participant|||Number
860074|NCT01732822|Primary|Composite of Cardiovascular (CV) Death/MI/Ischemic Stroke|Participants with CV death, myocardial infarction (MI) or ischemic stroke. If no event, censoring occurs at the minimum of (primary analysis censoring date (PACD), last endpoint assessment date, non-CV death date)|From randomization to PACD, an average of 2.5 years|The population was the full analysis set, which included all randomized patients.||Participants|||Number
860075|NCT01702909|Secondary|Median Survival|from time of study entry until death|measured from date of first dose until date of death|Data were not collected|||||
860076|NCT01702909|Secondary|Median Duration of Response|Duration of response is calculated as the time (months) from the date at which response is first observed (per standard Response Evaluation Criteria In Solid Tumors [RECIST] to the date of first observed disease progression or date of death from any cause, whichever came first, assessed up to 2 years. The actual date of tumor assessments was used for this calculation. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of one or more new lesions.|Measured from first response until Disease Progression or death from any cause up to 2 years|Data were not collected|||||
860077|NCT01702909|Primary|Number of Participants With Response Using RECIST Criteria|Radiographic studies to evaluate for response were done after every 2 cycles (6 weeks) until disease progression or death from any cause up to 2 years. Standard RECIST response criteria were utilized. Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response Rate (ORR) = 100%(CR + PR/total number of patients receiving Interleukin-2).|Measured until Disease Progression or death from any cause up to 2 year|||Participants|||Count of Participants
860078|NCT01688921|Secondary|Percentage of Subjects Who Received a PJ Stratis Injection Would Choose to Receive This Type of Injection Again||28 Days|Safety population||Percent of Participants|||Number
860079|NCT01688921|Secondary|Number of Subjects With Spontaneously Reported Adverse Events|"Subjects will be asked to report any other symptoms experienced in addition to the solicited immediate and vaccine reactogenicity events. Any other events reported will be tabulated as spontaneously reported adverse events."|28 days|The safety population included 1247 subjects (N=624 PJ Stratis, N=623 NS).||participants with spontaneous AEs|||Number
860080|NCT01688921|Secondary|Number of Subjects With Vaccine Reactogenicity Events|Vaccine reactogenicity will be collected on a patient-completed diary card during checkout from Day 0 and on the next six evenings post-vaccination. The following adverse events will be solicited on the diary card: pain at injection site, tenderness at injection site, redness where the injection is given; induration/swelling (lump) where the injection is given; bruising where the injection is given; itching where the injection is given; headache; tiredness/fatigue (asthenia, lethargy, malaise); general muscle ache (myalgia); chills; nausea; vomiting. Subjects will also record their oral temperature on the diary card each evening.|Day 0, 1, 2, 3, 4, 5, and 6|The safety population included 1247 subjects (N=624 PJ Stratis, N=623 NS). Eight subjects (624-616) in the PJ Stratis group and 16 (623-607) in the NS group did not return the 7-Day Diary Card.||participants|||Number
860081|NCT01688921|Secondary|Number of Subjects With Complaints Within 30 Minutes Following Vaccination||Within 30 minutes post-vaccination|The safety population included 1247 subjects (N=624 PJ Stratis, N=623 NS).||participants|||Number
860082|NCT01688921|Primary|Anti Influenza Type B Seroconversion|Seroconversion is defined as a 4-fold rise in HAI titer in post-immunization serum relative to pre-immunization serum, or if pre-immunization serum had an undetectable titer (<1:10), attainment of a post-immunization titer of ≥1:40.|28 days|The immunogenicity analyses were conducted using data from subjects in the Immunogenicity Population.||Percent of Participants|||Number
860083|NCT01688921|Primary|Anti Influenza Type A/H3N2 Seroconversion|Seroconversion is defined as a 4-fold rise in HAI titer in post-immunization serum relative to pre-immunization serum, or if pre-immunization serum had an undetectable titer (<1:10), attainment of a post-immunization titer of ≥1:40.|28 days|||Percent of Participants|||Number
860084|NCT01688921|Primary|Anti Influenza Type A/H1N1 Seroconversion|Seroconversion is defined as a 4-fold rise in HAI titer in post-immunization serum relative to pre-immunization serum, or if pre-immunization serum had an undetectable titer (<1:10), attainment of a post-immunization titer of ≥1:40.|28 days|The immunogenicity analyses were conducted using data from subjects in the Immunogenicity Population.||Percent of Participants|||Number
860085|NCT01688921|Primary|Anti Influenza Type B Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titer (GMT)|The GMT criterion for non-inferiority for the upper limit of the 95% CIs of the GMT ratio(GMT with NS / GMT with PJ Stratis) for each antigen to not exceed 1.5 fold.|28 days|The immunogenicity analyses were conducted using data from subjects in the Immunogenicity Population.||Titers||Standard Deviation|Geometric Mean
860086|NCT01688921|Primary|Anti Influenza Type A/H2N3 Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titer (GMT)|The GMT criterion for non-inferiority for the upper limit of the 95% CIs of the GMT ratio(GMT with NS / GMT with PJ Stratis) for each antigen to not exceed 1.5 fold.|28 days|The immunogenicity analyses were conducted using data from subjects in the Immunogenicity Population.||Titers||Standard Deviation|Geometric Mean
860087|NCT01688921|Primary|Anti Influenza Type A/H1N1 Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titer (GMT)|The GMT criterion for non-inferiority for the upper limit of the 95% CIs of the GMT ratio(GMT with NS / GMT with PJ Stratis) for A/H1N1 antigen will not exceed 1.5 fold.|28 days|The immunogenicity analyses were conducted using data from subjects in the Immunogenicity Population.||Titers||Standard Deviation|Geometric Mean
860088|NCT01684215|Secondary|Presence of Tumor Tissue Biomarkers- Estrogen Receptor (ER) H-Score, Retinoblastoma (Rb) H-Score, B-cell Lymphoma-1 (BCL-1) H-Score, P16 H-Score: Phase 2|Tumor tissue biomarkers ER, Rb, BCL-1 and P16 were analyzed to investigate possible associations with resistance or sensitivity to treatment with study drugs and were selected based on their known relevance to mechanisms involved in cell cycle regulation. Number of participants with positive ER (H-Score), Rb (H-Score), BCL-1 (H-Score) and P16 (H-Score) tumor tissue biomarkers were reported. The H-score is a method of assessing the extent of nuclear immunoreactivity, applicable to steroid receptors.|Baseline (Day 1)|Full analysis set included all enrolled participants who received at least 1 dose of study drug (PD-0332991).||participants|||Number
860089|NCT01684215|Secondary|Presence of Tumor Tissue Biomarker- Ki67: Phase 2|Tumor tissue biomarker, Ki67 was analyzed to investigate possible associations with resistance or sensitivity to treatment with study drugs and was selected based on its known relevance to mechanisms involved in cell cycle regulation. Number of participants with less than or equal to and greater than 20 percent of Ki67 tumor tissue biomarker were reported.|Baseline (Day 1)|Full analysis set included all enrolled participants who received at least 1 dose of study drug (PD-0332991).||participants|||Number
860090|NCT01684215|Secondary|Change From Baseline in Trial Outcome Index (TOI): Phase 2 at Day 1 of Cycle 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21 and End of Treatment|FACT is a modular approach to assess participant’s health-related quality of life. TOI total score was derived from the sum of these 3 sub-scale scores: physical well-being, functional well-being (both sub-scales consisting of 7 items ranging from 0 to 28, where higher scores indicating better quality of life) and breast cancer subscale (consists of 9 items and ranging from 0 to 36, where higher scores indicating better quality of life). Each individual item was rated on a 5-point Likert scale, ranging from 0 (not at all good) to 4 (very well), where higher scores indicating better quality of life. FACT-B total score range was of 0 (not at all good) to 92 (very well), where higher scores indicating better quality of life.|Baseline (Day 1 of Cycle 1), Day 1 of Cycle 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, End of treatment (Day 677)|"PRO analysis set was a subset of the full analysis set and included participants with both baseline and at least 1 complete post-baseline PRO assessment. Here, n signifies number of participants evaluable for specified time points."||units on a scale||95% Confidence Interval|Mean
860091|NCT01684215|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G): Phase 2 at Day 1 of Cycle 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21 and End of Treatment|FACT is a modular approach to assess participant’s health-related quality of life. FACT-G total score was derived from the sum of these 4 sub-scale scores: physical well-being, social/family well-being and functional well-being (all 3 sub-scales consisting of 7 items ranging from 0 to 28, where higher scores indicating better quality of life), emotional well-being (consists of 6 items and ranging from 0 to 24, where higher scores indicating better quality of life. Each individual item was rated on a 5-point Likert scale, ranging from 0 (not at all good) to 4 (very well), where higher scores indicating better quality of life. FACT-G total score range was of 0 (not at all good) to 108 (very well), where higher scores indicating better quality of life.|Baseline (Day 1 of Cycle 1), Day 1 of Cycle 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, End of treatment (Day 677)|"PRO analysis set was a subset of the full analysis set and included participants with both baseline and at least 1 complete post-baseline PRO assessment. Here, n signifies number of participants evaluable for specified time points."||units on a scale||95% Confidence Interval|Mean
860092|NCT01684215|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B): Phase 2 at Day 1 of Cycle 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21 and End of Treatment|The functional assessment of cancer therapy (FACT) is a modular approach to assess participant’s health-related quality of life. FACT-B total score was derived from the sum of these 5 sub-scale scores: physical well-being, social/family well-being and functional well-being (all 3 sub-scales consisting of 7 items ranging from 0 to 28, where higher scores indicating better quality of life), emotional well-being (consists of 6 items and ranging from 0 to 24, where higher scores indicating better quality of life, and a breast cancer subscale (consists of 9 items and ranging from 0 to 36, where higher scores indicating better quality of life). Each individual item was rated on a 5-point Likert scale, ranging from 0 (not at all good) to 4 (very well), where higher scores indicating better quality of life. FACT-B total score range was of 0 (not at all good) to 144 (very well), where higher scores indicating better quality of life.|Baseline (Day 1 of Cycle 1), Day 1 of Cycle 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, End of treatment (Day 677)|"Patient reported outcome (PRO) analysis set was a subset of the full analysis set and included participants with both baseline and at least 1 complete post-baseline PRO assessment. Here, n signifies number of participants evaluable for specified time points."||units on a scale||95% Confidence Interval|Mean
860093|NCT01684215|Secondary|Overall Survival (OS): Phase 2|Overall survival was defined as the time from first dose of study treatment to date of death due to any cause. In the absence of confirmation of death, survival time was censored to last date the participant was known to be alive. OS was estimated with Kaplan-Meier method.|From initiation of treatment up to follow-up period (up to 21 months)|Full analysis set included all enrolled participants who received at least 1 dose of study drug (PD-0332991).||months||95% Confidence Interval|Median
860094|NCT01684215|Secondary|Percentage of Participants With Disease Control (DC): Phase 2|Disease control was defined as CR, PR or stable disease for >=24 weeks according to the RECIST version 1.1 recorded in the time period between first dose of study treatment and disease progression or death to any cause. CR was defined as disappearance of all target lesions with the exception of nodal disease. All target nodes reduced to normal size (short axis <10 millimeter [mm]). PR was defined as >=30 percent decrease in sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. Stable disease was defined as not achieving an objective response with confirmed CR or PR according to RECIST version 1.1, as determined by the investigators, relative to the response evaluable population, but remained stable for at least 24 weeks after first dose, then the best overall response for such a participant was considered as stable disease. Percentage of participants with disease control were reported.|From initiation of treatment up to disease progression (up to 21 months)|Full analysis set included all enrolled participants who received at least 1 dose of study drug (PD-0332991).||percentage of participants|||Number
860095|NCT01684215|Secondary|Progression Free Survival (PFS): Part 2 Phase 1|PFS was defined as the time from first dose of study treatment to the date of the first documentation of objective progression of disease (PD) or death due to any cause in the absence of documented PD, whichever occurs first. PD was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|From initiation of treatment up to disease progression (up to 30 months)|Full analysis set included all enrolled participants who received at least 1 dose of study drug (PD-0332991). Data for this outcome measure was not summarized and individual participant's data was reported.||months|||Number
860096|NCT01684215|Secondary|Duration of Response (DOR): Phase 2|Duration of response was defined as the interval from the first documentation of objective tumor response in participants with CR (disappearance of all target lesions with the exception of nodal disease. All target nodes reduced to normal size (short axis <10 millimeter [mm]) or PR (a >=30 percent decrease in sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions) according to RECIST version 1.1 to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first.|From initiation of treatment up to disease progression (up to 21 months)|Full analysis set included all enrolled participants who received at least 1 dose of study drug (PD-0332991). Here, number of participants analyzed (N) signifies the participants evaluable for this outcome measure.||months||95% Confidence Interval|Median
860097|NCT01684215|Secondary|Duration of Response (DOR): Part 2 Phase 1|Duration of response was defined as the interval from the first documentation of objective tumor response in participants with CR (disappearance of all target lesions with the exception of nodal disease. All target nodes reduced to normal size (short axis <10 millimeter [mm]) or PR (a >=30 percent decrease in sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions) according to RECIST version 1.1 to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first.|From initiation of treatment up to disease progression (up to 30 months)|Full analysis set included all enrolled participants who received at least 1 dose of study drug (PD-0332991). Data for this outcome measure was not summarized and individual participant's data was reported. Here, number of participants analyzed (N) signifies the participants evaluable for this outcome measure.||months|||Number
860098|NCT01684215|Secondary|Percentage of Participants With Objective Response: Phase 2|Objective response was defined as a complete response (CR) or partial response (PR) according to the RECIST version 1.1 recorded from first dose of study treatment until disease progression or death due to any cause. CR was defined as disappearance of all target lesions with the exception of nodal disease. All target nodes reduced to normal size (short axis <10 millimeter [mm]). PR was defined as a >=30 percent decrease in sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. Percentage of participants with objective response (who achieved CR or PR) were reported.|From initiation of treatment up to disease progression (up to 21 months)|Full analysis set included all enrolled participants who received at least 1 dose of study drug (PD-0332991).||percentage of participants|||Number
860099|NCT01684215|Secondary|Percentage of Participants With Objective Response: Phase 1|Objective response was defined as a complete response (CR) or partial response (PR) according to the RECIST version 1.1 recorded from first dose of study treatment until disease progression or death due to any cause. CR was defined as disappearance of all target lesions with the exception of nodal disease. All target nodes reduced to normal size (short axis <10 millimeter [mm]). PR was defined as a >=30 percent decrease in sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. Percentage of participants with objective response (who achieved CR or PR) were reported.|From initiation of treatment up to disease progression (up to 30 months)|Full analysis set included all enrolled participants who received at least 1 dose of study drug (PD-0332991).||percentage of participants|||Number
860100|NCT01684215|Secondary|Pre-dose Plasma Concentration (Ctrough) of PD-0332991: Phase 2|Ctrough is pre-dose concentration during multiple dosing which is observed directly from the actual time-concentration data.|0 (pre-dose), 1, 2, 4, 6, 8, 10, 24 hours post dose on Cycle 1 Day 15|PK parameter analysis set included treated participants who had at least 1 of the PK parameters of primary interest in at least 1 PK sampling period.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
860101|NCT01684215|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PD-0332991: Phase 2|Tmax is time at which maximum plasma concentration (Cmax) was observed. It was observed directly from data as time of first occurrence.|0 (pre-dose), 1, 2, 4, 6, 8, 10, 24 hours post dose on Cycle 1 Day 15|PK parameter analysis set included treated participants who had at least 1 of the PK parameters of primary interest in at least 1 PK sampling period.||hour||Full Range|Median
860102|NCT01684215|Secondary|Maximum Observed Plasma Concentration (Cmax) Of PD-0332991: Phase 2|Cmax is maximum plasma concentration which is observed directly from the actual time-concentration data.|0 (pre-dose), 1, 2, 4, 6, 8, 10, 24 hours post dose on Cycle 1 Day 15|PK parameter analysis set included treated participants who had at least 1 of the PK parameters of primary interest in at least 1 PK sampling period.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
860103|NCT01684215|Secondary|Apparent Oral Clearance of PD-0332991: Phase 2|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. It was calculated by dividing the given oral dose by AUCtau. AUCtau is the area under the plasma concentration-time curve over dosing interval which is calculated by log-linear trapezoidal method.|0 (pre-dose), 1, 2, 4, 6, 8, 10, 24 hours post dose on Cycle 1 Day 15|PK parameter analysis set included treated participants who had at least 1 of the PK parameters of primary interest in at least 1 PK sampling period.||L/hr||Geometric Coefficient of Variation|Geometric Mean
860104|NCT01684215|Secondary|Area Under the Plasma Concentration Time Curve Over Dosing Interval (AUCtau) of PD-0332991: Phase 2|AUCtau is area under the plasma concentration-time curve over dosing interval which is calculated by log-linear trapezoidal method.|0 (pre-dose), 1, 2, 4, 6, 8, 10, 24 hours post dose on Cycle 1 Day 15|PK parameter analysis set included treated participants who had at least 1 of the PK parameters of primary interest in at least 1 PK sampling period.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
860105|NCT01684215|Secondary|Volume of Distribution (Vz/F) of PD-0332991 Following Single Dose: Part 1 Phase 1|Vz/F is apparent volume of distribution estimated from terminal phase, which is calculated as CL/F/kel. Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. It was calculated by dividing the given oral dose by area under the plasma concentration-time curve from 0 to infinity which is calculated by log-linear trapezoidal method (AUCinf). kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.|Single dose: 0 hour (pre-dose), 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose in Lead-in period (Day -7)|PK parameter analysis set included treated participants who had at least 1 of the PK parameters of primary interest in at least 1 PK sampling period.||liter||Geometric Coefficient of Variation|Geometric Mean
860106|NCT01684215|Secondary|Terminal Half-Life (t1/2) of PD-0332991: Part 1 Phase 1|t1/2 is terminal elimination half-life which is calculated by loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.|Single dose: 0 hour (pre-dose),1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose in Lead-in period (Day -7), Multiple dose: 0 hour (pre-dose), 1, 2, 4, 6, 8, 12, 24 hours post-dose on Cycle 1 Day 8|PK parameter analysis set included treated participants who had at least 1 of the PK parameters of primary interest in at least 1 PK sampling period.||hour||Standard Deviation|Mean
860107|NCT01684215|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PD-0332991: Part 1 Phase 1|Tmax is time at which maximum plasma concentration (Cmax) was observed. It was observed directly from data as time of first occurrence.|Single dose: 0 hour (pre-dose),1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose in Lead-in period (Day -7), Multiple dose: 0 hour (pre-dose), 1, 2, 4, 6, 8, 12, 24 hours post-dose on Cycle 1 Day 8|PK parameter analysis set included treated participants who had at least 1 of the PK parameters of primary interest in at least 1 PK sampling period.||hour||Full Range|Median
860108|NCT01684215|Secondary|Linearity (Rss) of PD-0332991 Following Multiple Dose: Part 1 Phase 1|Rss is the ratio of AUCtau (after multiple doses) to AUCinf (after single dose). AUCtau is area under the plasma concentration-time curve over dosing interval which is calculated by log-linear trapezoidal method. AUCinf is area under the plasma concentration-time curve from 0 to infinity which is calculated by log-linear trapezoidal method.|Single dose: 0 hour (pre-dose), 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose in Lead-in period (Day -7), Multiple dose: 0 hour (pre-dose), 1, 2, 4, 6, 8, 12, 24 hours post-dose on Cycle 1 Day 8|PK parameter analysis set included treated participants who had at least 1 of the PK parameters of primary interest in at least 1 PK sampling period.||ratio||Full Range|Median
860109|NCT01684215|Secondary|Accumulation Ratio (Rac) of PD-0332991 Following Multiple Dose: Part 1 Phase 1|Rac is the ratio of AUCtau (after multiple doses) to AUCtau (after single dose). AUCtau is area under the plasma concentration-time curve over dosing interval which is calculated by log-linear trapezoidal method.|Single dose: 0 hour (pre-dose), 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose in Lead-in period (Day -7), Multiple dose: 0 hour (pre-dose), 1, 2, 4, 6, 8, 12, 24 hours post-dose on Cycle 1 Day 8|PK parameter analysis set included treated participants who had at least 1 of the PK parameters of primary interest in at least 1 PK sampling period.||ratio||Full Range|Median
860110|NCT01684215|Secondary|Pre-dose Plasma Concentration (Ctrough) of PD-0332991 Following Multiple Dose: Part 1 Phase 1|Ctrough is pre-dose concentration during multiple dosing which is observed directly from the actual time-concentration data.|Multiple dose: 0 hour (pre-dose), 1, 2, 4, 6, 8, 12, 24 hours post-dose on Cycle 1 Day 8|PK parameter analysis set included treated participants who had at least 1 of the PK parameters of primary interest in at least 1 PK sampling period.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
860111|NCT01684215|Secondary|Cmax Dose Normalized to 125 mg of PD-0332991: Part 1 Phase 1|Cmax Dose Normalized to 125 mg is maximum plasma concentration dose normalized to 125 mg which is observed directly from the actual time-concentration data.|Single dose: 0 hour (pre-dose),1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose in Lead-in period (Day -7), Multiple dose: 0 hour (pre-dose), 1, 2, 4, 6, 8, 12, 24 hours post-dose on Cycle 1 Day 8|PK parameter analysis set included treated participants who had at least 1 of the PK parameters of primary interest in at least 1 PK sampling period.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
860112|NCT01684215|Secondary|Maximum Observed Plasma Concentration (Cmax) Of PD-0332991: Part 1 Phase 1|Cmax is maximum plasma concentration which is observed directly from the actual time-concentration data.|Single dose: 0 hour (pre-dose),1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose in Lead-in period (Day -7), Multiple dose: 0 hour (pre-dose), 1, 2, 4, 6, 8, 12, 24 hours post-dose on Cycle 1 Day 8|PK parameter analysis set included treated participants who had at least 1 of the PK parameters of primary interest in at least 1 PK sampling period.||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
860113|NCT01684215|Secondary|Apparent Oral Clearance of PD-0332991: Part 1 Phase 1|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. It was calculated by dividing the given oral dose by AUCinf. AUCinf is area under the plasma concentration-time curve from 0 to infinity which is calculated by log-linear trapezoidal method.|Single dose: 0 hour (pre-dose),1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose in Lead-in period (Day -7), Multiple dose: 0 hour (pre-dose), 1, 2, 4, 6, 8, 12, 24 hours post-dose on Cycle 1 Day 8|PK parameter analysis set included treated participants who had at least 1 of the PK parameters of primary interest in at least 1 PK sampling period.||liter per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
860114|NCT01684215|Secondary|AUClast Dose Normalized to 125 mg of PD-0332991 Following Single Dose: Part 1 Phase 1|AUClast Dose Normalized to 125 mg is area under the plasma concentration-time curve from 0 to time of last measurable concentration dose normalized to 125 mg which is calculated by log-linear trapezoidal method.|Single dose: 0 hour (pre-dose), 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose in Lead-in period (Day -7)|PK parameter analysis set included treated participants who had at least 1 of the PK parameters of primary interest in at least 1 PK sampling period.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
860115|NCT01684215|Secondary|Area Under the Plasma Concentration-Time Curve From 0 to Time of Last Measurable Concentration (AUClast) of PD-0332991 Following Single Dose: Part 1 Phase 1|AUClast is area under the plasma concentration-time curve from 0 to time of last measurable concentration which is calculated by log-linear trapezoidal method.|Single dose: 0 hour (pre-dose), 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose in Lead-in period (Day -7)|PK parameter analysis set included treated participants who had at least 1 of the PK parameters of primary interest in at least 1 PK sampling period.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
860116|NCT01684215|Secondary|AUCinf Dose Normalized to 125 mg of PD-0332991 Following Single Dose: Part 1 Phase 1|AUCinf Dose Normalized to 125 mg is area under the plasma concentration-time curve from 0 to infinity dose normalized to 125 mg which is calculated by log-linear trapezoidal method.|Single dose: 0 hour (pre-dose), 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose in Lead-in period (Day -7)|PK parameter analysis set included treated participants who had at least 1 of the PK parameters of primary interest in at least 1 PK sampling period.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
860117|NCT01684215|Secondary|Area Under the Plasma Concentration-Time Curve From 0 to Infinity (AUCinf) of PD-0332991 Following Single Dose: Part 1 Phase 1|AUCinf is area under the plasma concentration-time curve from 0 to infinity which is calculated by log-linear trapezoidal method.|Single dose: 0 hour (pre-dose), 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose in Lead-in period (Day -7)|PK parameter analysis set included treated participants who had at least 1 of the PK parameters of primary interest in at least 1 PK sampling period.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
860118|NCT01684215|Secondary|AUC24 Dose Normalized to 125 mg of PD-0332991 Following Single Dose: Part 1 Phase 1|AUC24 Dose Normalized to 125 mg is area under the plasma concentration-time curve from 0 to time 24 hours dose normalized to 125 mg which is calculated by log-linear trapezoidal method.|Single dose: 0 hour (pre-dose), 1, 2, 4, 6, 8, 12 and 24 hours post-dose in Lead-in period (Day -7)|PK parameter analysis set included treated participants who had at least 1 of the PK parameters of primary interest in at least 1 PK sampling period.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
860119|NCT01684215|Secondary|Area Under the Plasma Concentration-Time Curve From 0 to Time 24 Hours (AUC24) of PD-0332991 Following Single Dose: Part 1 Phase 1|AUC24 is area under the plasma concentration-time curve from 0 to time 24 hours which is calculated by log-linear trapezoidal method.|Single dose: 0 hour (pre-dose), 1, 2, 4, 6, 8, 12 and 24 hours post-dose in Lead-in period (Day -7)|PK parameter analysis set included treated participants who had at least 1 of the PK parameters of primary interest in at least 1 PK sampling period.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
860120|NCT01684215|Secondary|AUCtau Dose Normalized to 125 Milligram (mg) of PD-0332991 Following Multiple Dose: Part 1 Phase 1|AUCtau Dose Normalized to 125 mg is area under the plasma concentration-time curve over dosing interval dose normalized to 125 mg which is calculated by log-linear trapezoidal method.|Multiple dose: 0 hour (pre-dose), 1, 2, 4, 6, 8, 12, 24 hours post-dose on Cycle 1 Day 8|PK parameter analysis set included treated participants who had at least 1 of the PK parameters of primary interest in at least 1 PK sampling period.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
860121|NCT01684215|Secondary|Area Under the Plasma Concentration Time Curve Over Dosing Interval (AUCtau) of PD-0332991 Following Multiple Dose: Part 1 Phase 1|AUCtau is area under the plasma concentration-time curve over dosing interval which is calculated by log-linear trapezoidal method.|Multiple dose: 0 hour (pre-dose), 1, 2, 4, 6, 8, 12, 24 hours post-dose on Cycle 1 Day 8|Pharmacokinetic (PK) parameter analysis set included treated participants who had at least 1 of the PK parameters of primary interest in at least 1 PK sampling period.||nanogram*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
860122|NCT01684215|Secondary|Number of Participants With Clinically Significant Laboratory Abnormalities|Abnormality criteria: hemoglobin: <0.8*lower limit of normal [LLN], platelets: <0.5*LLN or >1.75*upper limit of normal [ULN], leukocytes: <0.6*LLN or >1.5*ULN, lymphocytes, total neutrophils: <0.8*LLN or >1.2*ULN, basophils, eosinophil,monocytes: >1.2*ULN); aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma glutamyl transferase (GT): >0.3*ULN, total protein, albumin: <0.8*LLN or >1.2*ULN, total bilirubin, direct bilirubin: >1.5*ULN; blood urea nitrogen, creatinine: >1.3*ULN, uric acid: >1.2*ULN; sodium: <0.95*LLN or >1.05*ULN, potassium, chloride, calcium, magnesium: <0.9*LLN or >1.1*ULN, phosphate: <0.8*LLN or >1.2*ULN; creatine kinase: >2.0*ULN, glucose fasting: <0.6*LLN or >1.5*ULN, glycosylated haemoglobin: >1.3*ULN;urinalysis dipstick (urine protein, urine blood >=1); urine protein 24 hour: >1.1*ULN; coagulation Activated partial thromboplastin time [APTT], Prothrombin, prothrombin international ratio: >1.1*ULN.|Lead- in period (Day -7) up to end of treatment (Day 677)|Safety analysis set included all enrolled participants who received at least 1 dose of study drug (PD-0332991).||participants|||Number
860123|NCT01684215|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) By Severity: Phase 1 (Part 1) and Phase 2|AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An AE was considered treatment emergent if occurred for the first time after the start of study treatment or occurred prior to the start of treatment but increased in NCI CTCAE grade during study treatment period. AE severity was defined to be the maximum toxicity grade of the TEAEs experienced by the participants during the study. AE was assessed according to severity as: Grade 1 (mild AE), Grade 2 (moderate AE), Grade 3 (severe AE), Grade 4 (life-threatening consequences) and Grade 5 (death related to AE).|Part 1 Phase 1: Lead-in period (Day -7) up to 28 days after last dose of study drug (Day 308), Phase 2: Baseline (Day 1) up to 28 days after last dose of study drug (Day 677)|Safety analysis set included all enrolled participants who received at least 1 dose of study drug (PD-0332991).||participants|||Number
860124|NCT01684215|Secondary|Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs): Phase 1 (Part 1) and Phase 2|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both serious and non-serious adverse events.|Part 1 Phase 1: Lead-in period (Day -7) up to 28 days after last dose of study drug (Day 308), Phase 2: Baseline (Day 1) up to 28 days after last dose of study drug (Day 677)|Safety analysis set included all enrolled participants who received at least 1 dose of study drug (PD-0332991).||participants|||Number
860125|NCT01684215|Primary|Percentage of Participants With 1 Year Progression Free Survival (PFS): Phase 2|PFS was defined as the time from first dose of study treatment to the date of the first documentation of objective progression of disease (PD) or death due to any cause in the absence of documented PD, whichever occurs first. PD was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.1-year PFS was defined as the percentage of participants without PFS events (PD or death due to any cause) at 12 months based on the Kaplan-Meier estimate. Percentage of participants with 1-year PFS with 90% confidence interval (CI) were reported.|From initiation of treatment up to follow-up period (up to 12 months)|Full analysis set included all enrolled participants who received at least 1 dose of study drug (PD-0332991).||percentage of participants||90% Confidence Interval|Number
860126|NCT01684215|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) By Severity: Part 2 Phase 1|AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An AE was considered treatment emergent if occurred for the first time after the start of study treatment or occurred prior to the start of treatment but increased in National Cancer Institute (NCI) CTCAE grade during study treatment period. AE severity was defined to be the maximum toxicity grade of the TEAEs experienced by the participants during the study. AE was assessed according to severity as: Grade 1 (mild AE), Grade 2 (moderate AE), Grade 3 (severe AE), Grade 4 (life-threatening consequences) and Grade 5 (death related to AE).|Baseline (Day 1) up to 28 days after last dose of study drug (Day 677)|Safety analysis set included all enrolled participants who received at least 1 dose of study drug (PD-0332991).||participants|||Number
860127|NCT01684215|Primary|Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs): Part 2 Phase 1|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both serious and non-serious adverse events.|Baseline (Day 1) up to 28 days after last dose of study drug (Day 677)|Safety analysis set included all enrolled participants who received at least 1 dose of study drug (PD-0332991).||participants|||Number
860128|NCT01684215|Primary|Number of Participants With Dose Limiting Toxicities (DLT): Part 1 Phase 1|DLT was classified as per common terminology criteria for adverse events (CTCAE) version 4.0 as any of the events occurring during 28 days of Cycle 1,attributed to study drug:grade 4 neutropenia(for a duration of greater than [>]7 days); febrile neutropenia (grade greater than or equal to [>=]3 neutropenia,body temperature >=38.5 degree Celsius);grade >=3 thrombocytopenia with bleeding episode;grade 4 thrombocytopenia;grade >=3 non-hematologic toxicity except grade 3 or more nausea, vomiting,electrolyte abnormality(if controllable by therapy);grade 3 QTc prolongation(>500 millisecond [msec])persist after correction of reversible cause such as electrolyte abnormalities or hypoxia. Lack of hematologic recovery (platelets less than [<]50,000/microliter [mcL],absolute neutrophil count <1,000/mcL,hemoglobin <8.0 gram/deciliter [g/dL]) or prolonged non hematologic toxicities that delays initiation of next dose by >7 days;receipt of <75 percent of planned dose in first cycle due to toxicity.|Lead-in period (Day -7) up to Day 28 (Cycle 1)|DLT analysis set included all participants whom DLTs were evaluable in Part 1 Phase 1.||participants|||Number
860129|NCT01668784|Secondary|Number of Participants With Abnormal Hematology and Serum Chemistry Laboratory Parameters by Worse CTC Grade - SI Units|Common Terminology Criteria (CTC) version 4.0 in International System of Units (SI); Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. Hematology parameters=Hemoglobin (Gr 3: < 8.0 g/dL), Platelet Count (Gr 3: 25.0 -< 50.0*10^9 c/L; Gr 4: < 25.0*10^9 c/L), Leukocyte Count (Gr 3: 1.0 -< 2.0*10^3 c/µL; Gr4: < 1.0*10^3 c/µL), Absolute Lymphocyte Count (Gr 3: 0.2 -< 0.5*10^3 c/µL; Gr 4: < 0.2*10^3 c/µL), Absolute Neutrophil Count (Gr 3: 0.5 - < 1.0*10^3 c/µL; Gr 4: < 0.5*10^3 c/µL). Liver Function parameters=Alkaline Phosphatase (Gr 3: > 5.0 - 20.0 U/L * ULN; Gr 4: > 20.0 U/L * ULN), AST (Gr 3: > 5.0 - 20.0 U/L * ULN; Gr 4: > 20.0 U/L * ULN), ALT (Gr 3: > 5.0 - 20.0 U/L * ULN; Gr 4: > 20.0 U/L * ULN), tBIL (Gr 3: > 3.0 - 10.0 mg/dL * ULN; Gr 4: > 10.0 mg/dL * ULN). Renal parameter=Creatinine (Grade: Gr3: > 3.0 - 6.0 mg/dL *ULN; Gr4: > 6.0 mg/dL *ULN). Cells per microliter (c/µL). Cells per Liter (c/L). Grams per deciliter (g/dL). Milligrams per deciliter (mg/dL).|Day 1 to 30 days post last dose, up to May 2015 (approximately 30 months)|All treated participants; all participants who received at least one dose of nivolumab or everolimus and at least one measureable on-treatment measurement of the corresponding laboratory parameter||participants|||Number
860130|NCT01668784|Secondary|Number of Participants Meeting Marked Laboratory Abnormality Criteria in Specific Liver and Thyroid Tests at Primary Endpoint|Aspartate aminotransferase, AST. Alanine aminotransaminase, ALT. Total bilirubin, tBIL. Thyroid stimulating hormone, TSH. Upper limit of normal (ULN). Units per Liter (U/L). Results reported in International System of Units (SI).|Day 1 to 30 days post last dose, up to May 2015 (approximately 30 months)|All treated participants who received at least one dose of nivolumab or everolimus and had at least one measureable on-treatment measurement of the corresponding laboratory parameters||participants|||Number
860131|NCT01668784|Secondary|Percentage of Participants With Disease-related Symptom Progression (DRSP) at Primary Endpoint|Disease-related symptom progression rate (DRSPR)=a decrease of two points in the Functional Assessment of Cancer Therapy-Kidney Symptom Index - Disease Related Symptoms (FKSI-DRS) questionnaire relative to the participant's baseline FKSI-DRS score with no later increase above this threshold observed during the course of the study. The 9 items of the FKSI-DRS were summarized into a symptom scale ranging in score from 0 to 36, with 0 being the worst possible score and 36 being the best possible score. A single measure reporting a decrease of at least 2 units was considered disease-related symptom progression only if it was the last one available for the participant. In order to consider a questionnaire received as valid, over 50% of the items were to be completed. Calculated by the Clopper-Pearson method for each treatment group.|Randomization until 398 deaths, up to May 2015 (approximately 30 months)|All randomized participants; any participants that was randomized to any treatment group in the study.||percentage of participants||95% Confidence Interval|Number
860132|NCT01668784|Secondary|Number of Participants With Serious Adverse Events, Death, Discontinuation Due to Adverse Events at Primary Endpoint|Adverse event (AE) defined: any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Serious adverse event (SAE) defined: a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|Day of first dose to 30 days post final dose, up to May 2015 (approximately 30 months)|All treated participants; all participants who received at least one dose of nivolumab or everolimus||participants|||Number
860179|NCT01454076|Secondary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)||Cycle 1 Day 1 up to 30 days after last dose of study drug (Arm 1 and 5: Cycle 19 Day 45; Arm 2: Cycle 7 Day 45; Arm 3: Cycle 22 Day 45; Arm 4: Cycle 25 Day 45)|The safety population included all participants who received at least one dose of any study drug.||participants|||Number
860133|NCT01668784|Secondary|Overall Survival (OS) by Programmed Death-Ligand 1 (PD-L1) Expression Level at Primary Endpoint|Quantifiable PD-L1 expression=percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per Dako PD-L1 IHC assay. If the PD-L1 staining could not be quantified it was classified as: indeterminate=tumor cell membrane staining hampered for reasons attributed to biology of tumor biopsy specimen and not due to improper sample preparation or handling; not evaluable=tumor biopsy specimen was not optimally collected or prepared. Not evaluable determined from H&E process before the tumor biopsy specimen was sent for evaluation or from H&E process during PD-L1 evaluation; baseline PD-L1 expression=if more than one tumor biopsy specimen was available, the most recently collected specimen with a quantifiable result. If all specimens for a given participant are either indeterminate or not evaluable, then the PD-L1 expression was considered indeterminate as long as at least one specimen is indeterminate. Otherwise, PD-L1 expression was considered not evaluable.|Randomization to date of death or date of last contact for patients without documentation of death, up to May 2015 (approximately 30 months)|PD-L1 quantifiable participants; All randomized participants with quantifiable PD-L1 expression at baseline||months||95% Confidence Interval|Median
860134|NCT01668784|Secondary|Investigator-assessed Time of Progression-free Survival (PFS) at Primary Endpoint|PFS=time from randomization to date of first documented tumor progression as determined by investigator (per RECIST 1.1 criteria or clinical) or death due to any cause, whichever occurred first. Participants who die without a reported prior progression and without subsequent anti-cancer therapy were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who did not have any on-study tumor assessments and did not die were censored on the date they were randomized. Participants who received any subsequent anti-cancer therapy without a prior reported progression were censored at the last evaluable tumor assessment prior to or on initiation date of the subsequent anti-cancer therapy. Progressive disease: >=20% increase in sum of target lesion diameters and sum must show absolute increase of >=5mm; smallest sum on study as reference. Based on Kaplan-Meier Estimates.|Randomization until 398 deaths, up to May 2015 (approximately 30 months)|All randomized participants; any participants that was randomized to any treatment group in the study.||months||95% Confidence Interval|Median
860135|NCT01668784|Secondary|Investigator-assessed Time to Objective Response at Primary Endpoint|Time to objective response is defined as the time from randomization to first response (complete response, CR or partial response, PR). CR=Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; PR=At least a 30% decrease in the sum of diameters of target lesions, the baseline sum diameters used as reference.|Randomization to date of first response, up to May 2015 (approximately 30 months)|All randomized participants with a response; any participants that was randomized to any treatment group in the study and that had a response.||months||Full Range|Median
860136|NCT01668784|Secondary|Investigator-assessed Duration of Objective Response at Primary Endpoint|Duration of objective response is defined as the time from first response (complete response, CR or partial response, PR) to the date of the first documented tumor progression as determined by the investigator (per RECIST 1.1 criteria or clinical) or death due to any cause, whichever occurred first. For participants who neither progress nor die, the duration of objective response were censored at the same time they were censored for the primary definition. CR=Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; PR=At least a 30% decrease in the sum of diameters of target lesions, the baseline sum diameters used as reference. Based on Kaplan-Meier Estimates.|From date of first response to date of disease progression or death or censoring if no progression or death occurred, up to May 2015 (approximately 30 months)|All randomized participants with a response; any participants that were randomized to any treatment group in the study and that had a response.||months||95% Confidence Interval|Median
860137|NCT01668784|Secondary|Investigator-assessed Objective Response Rate (ORR) at Primary Endpoint|ORR=number of participants with a best response of complete response (CR) or partial response (PR) divided by number of randomized participants. CR=Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; PR=At least a 30% decrease in the sum of diameters of target lesions, the baseline sum diameters used as reference. Tumor assessments began at 8 weeks following randomization and continued every 8 weeks for the first year, then every 12 weeks thereafter until disease progression or death. CIs used Clopper and Pearson.|At 8 weeks post randomization, every 8 weeks for 12 months, and every 12 weeks until date of disease progression or death, up to May 2015 (approximately 30 months)|All randomized participants; any participants that was randomized to any treatment group in the study.||percentage of participants||95% Confidence Interval|Number
860138|NCT01668784|Primary|Overall Survival (OS) at Primary Endpoint|"Overall Survival (OS) was defined as the time from randomization to the date of death. Participants that had not died were censored at last known date alive. Median OS time was calculated using Kaplan-Meier Estimates. Interim analysis for the Primary Endpoint occurred after 398 deaths (70% of the total OS events needed for final analysis). At that time the data monitoring committee noted that the pre-specified boundary for OS (nominal significance level p < 0.0148) was crossed while no new safety signals that would affect continuation of the study were found.
The study was stopped early by the Sponsor, Bristol-Myers Squibb (BMS) and the interim analysis became the final analysis. As a result, participants in the everolimus groups could be assessed for a crossover to nivolumab treatment if they met all inclusion criteria."|Randomization until 398 deaths, up to May 2015 (approximately 30 months)|All randomized participants; any participants that was randomized to any treatment group in the study.||months||95% Confidence Interval|Median
860139|NCT01641471|Secondary|Clinical Outcomes (Functional & General Health)|Measured from modified KOOS and SF-12 v2 questionnaires.|Within 30 days before surgery, 2 weeks (+/- 3 days) after surgery, 4 weeks (+/- 3 days) after surgery, 6 weeks (+/- 3 days) after surgery||||||
860140|NCT01641471|Secondary|Functional Assessments|Measured from ROM measurement and timed up and go (TUG) test.|Within 30 days before surgery, daily during hospital stay (an expected average of 4 days), 2 weeks (+/- 3 days) after surgery, 4 weeks (+/- 3 days) after surgery, 6 weeks (+/- 3 days) after surgery||||||
860141|NCT01641471|Secondary|Visual Analog Pain Score (VAS)||Within 30 days before surgery, daily during hospital stay (an expected average of 4 days), 2 weeks (+/- 3 days) after surgery, 4 weeks (+/- 3 days) after surgery, 6 weeks (+/- 3 days) after surgery||||||
860143|NCT01625182|Secondary|Change From Baseline for Rasch-Built Linearly Weighted Overall Disability Scale (R-ODS)|This questionnaire was constructed using the patients’ perception of their ability to perform daily and social activities. The questionnaire comprises 24 items ranging from ability to read a book or newspaper (as the easiest item to accomplish) to ability to run (most difficult item to accomplish). The obtained raw summed score was translated subsequently to a convenient centile metric score ranging from 0 (most severe disability) to 100 (no disability at all). A higher score indicated a better health status. A negative change from baseline indicates deterioration.|baseline, Month 6, Month 12|Only participants from the FAS, who had non-missing baseline values and the given post-baseline values, were included in the analysis. The FAS included all participants who were assigned randomly to receive treatment.||score on a scale||95% Confidence Interval|Least Squares Mean
860144|NCT01625182|Secondary|Change From Baseline for Grip Strength, Non-dominant Hand|Grip strength measurements were done using a vigorimeter. With this device, the pressure in the bulb exercised by the participant was registered on a manometer via a rubber junction tube. Both the dominant and non-dominant hands were tested. A negative change from baseline indicates deterioration.|baseline, Month 6, Month 12|Only participants from the FAS, who had non-missing baseline values and the given post-baseline values, were included in the analysis. The FAS included all participants who were assigned randomly to receive treatment.||kPa||95% Confidence Interval|Least Squares Mean
860145|NCT01625182|Secondary|Change From Baseline for Grip Strength, Dominant Hand|Grip strength measurements were done using a vigorimeter. With this device, the pressure in the bulb exercised by the participant was registered on a manometer via a rubber junction tube. Both the dominant and non-dominant hands were tested. A negative change from baseline indicates deterioration.|baseline, Month 6, Month 12|Only participants from the FAS, who had non-missing baseline values and the given post-baseline values, were included in the analysis. The FAS included all participants who were assigned randomly to receive treatment.||kPa||95% Confidence Interval|Least Squares Mean
860146|NCT01625182|Primary|Time to First Confirmed Worsening on the Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Scale|Confirmed worsening in CIDP was measured by the adjusted INCAT Disability Scale. The adjusted INCAT disability scale measures arm disability and leg disability. For arm disability the scale ranges from 0 (no upper limb problems) to 5 (inability to use either arm for any purposeful movement). The leg disability scale ranges from 0 (walking not affected) to 5 (restricted to wheelchair, unable to stand and walk a few steps with help). The total adjusted INCAT disability score is calculated by the sum of the arm and leg disability scores where the total score ranges from 0 to 10. A confirmed worsening was defined as an increase by 1 or more points on the adjusted INCAT disability scale from the value at baseline.|Month 12|The full analysis set, which included all participants who were assigned randomly to receive treatment, was analyzed.||Days||95% Confidence Interval|Median
860147|NCT01615731|Secondary|Adverse Events|uterine perforation, uterine injury, etc.|Intraoperatively and 2 weeks post operatively|||participants|||Number
860148|NCT01615731|Secondary|Overall Patient Experience|Used a Visual Analogue Scale to determine the patient's overall satisfaction with her experience. The VAS ranges from 0-100. 0 being a worse than expected experience, 50 being what the patient expected and 100 being a better than expected experience.|Measured post operatively (at least 30 minutes, on average 1.5 hours) prior to discharge|||units on a scale||Inter-Quartile Range|Median
860149|NCT01615731|Secondary|Pain Perceived by Patient|Used a Visual Analogue Scale to determine the pain perceived by the patient pre-operatively (after misoprostol, immediately before transport to OR) and post-operatively (in recovery room, on average 1.5 hours post-operatively). The VAS ranges from 0-100. 0 being no pain felt by the patient and 100 being the worst pain imaginable felt by the patient.|Measured pre-operatively (after misoprostol, immediately before transport to OR) and post-operatively (in recovery room, on average 1.5 hours post-operatively)|||units on a scale||Inter-Quartile Range|Median
860150|NCT01615731|Secondary|Ease of Procedure by Blinded Surgeon|Used a Visual Analogue Scale to determine the ease of procedure by blinded surgeon. The VAS ranges from 0-100. 0 being the easiest procedure the surgeon felt they had every performed and 100 being the most difficult procedure imaginable by the surgeon.|Measured Immediately after procedure|||units on a scale||Inter-Quartile Range|Median
860151|NCT01615731|Secondary|Adverse Events (EBL)|One adverse event: Estimated Blood Loss|Intraoperatively|||mL||Standard Deviation|Mean
860152|NCT01615731|Secondary|Maximum Cervical Dilation|Measured by estimate with bimanual exam and passage of largest dilator immediately prior to procedure.|Measured intra-operatively|"Data missing for one subject in Mifepristone plus one set of dilators arm."||participants|||Number
860153|NCT01615731|Primary|Procedure Time|Measured as time from speculum insertion to removal|Intraoperative Time|||minutes||Standard Deviation|Mean
860154|NCT01607346|Secondary|Change From Baseline in PVR Volume by Bladder Ultrasound at Visits 3, 4, 5 and 6|PVR is the the amount of urine left in the bladder after urination. Bladder ultrasound was performed to assess PVR at Baseline/Visit 2 (Day -1), Visit 3 (Day 21), Visit 4 (Day 35), Visit 5 (Day 49) and Visit 6 (follow-up visit within 14 days after the end-of-treatment eye examination). Change from Baseline was calculated by subtracting the Baseline value from the post-baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Up to Day 80 (Visit 6)|Safety Population||mL||Standard Deviation|Mean
860155|NCT01607346|Secondary|Cystometry Assessment at Visits 3, 4, 5 and 6|Cystometry is a test of bladder function in which pressure and volume of fluid in the bladder is measured during filling, storage, and voiding. Cystometry was assessed at Baseline visit 2 (Day -1) and on visit 3 (Day 21), visit 4 (Day 35), visit 5 (Day 49) and visit 6 (follow-up visit within 14 days after the end-of-treatment eye examination). The requirement for cystometry was discovered by the study monitor and discussed with the GSK medical monitor after the participants had completed the study.|Up to Day 80 (Visit 6)|Data were not collected, although 3 participants met at least 1 of the criteria for multichannel cystometry during the study, the assessment was not performed.|||||
860212|NCT01272232|Secondary|Change (%-Points) From Baseline in HbA1c (Glycosylated Haemoglobin A1c)|Change in HbA1c (%-points) was calculated as the difference between the HbA1c (%) at Week 0 and Week 56.|Week 0, week 56|Last Observation Carried Forward (LOCF) data. Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.||percentage point change of HbA1c||Standard Deviation|Mean
860156|NCT01607346|Secondary|Change From Baseline in American Urological Association Symptom Index (AUA SI) at Visits 3, 4, 5 and 6|The America Urological Association Symptom Index is a 7-item Likert-scored scale describing urinary bladder function. It is the sum of the responses to the 7 AUA symptom questions. Score ranges from 0 to 5 (0=not at all and 5=almost always for questions 1 to 6; 0=None and 5=five times or more for question 7). The total score ranges from 0-35 where higher scores indicate more severe symptoms. It was completed by the investigator at Baseline visit 2 (Day -1) and on visit 3 (Day 21), visit 5 (Day 49) and visit 6 (follow-up visit within 14 days after the end-of-treatment eye examination). Measurement at visit 2 (Day -1) was considered as Baseline value. Change from Baseline was calculated by subtracting the Baseline value from the post-baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline (Day -1) and up to Day 80 (Visit 6)|Safety Population||Scores on a scale||Standard Deviation|Mean
860157|NCT01607346|Secondary|Volume Voided as Recorded on the Voiding Diary for 2 Days Prior to Each Post-baseline Visit|The participants were asked to complete a voiding diary for two days preceding each visit. Volume voided for 2 days prior to each visit was defined as sum of urine recorded within 2 days prior to each post-baseline visit. Voiding diary was assessed at Baseline visit 2 (Day -1) and on visit 3 (Day 21), visit 4 (Day 35), visit 5 (Day 49) and visit 6 (follow-up visit within 14 days after the end-of-treatment eye examination). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline (Day -1) and up to Day 80 (Visit 6)|Safety Population||mL||Standard Deviation|Mean
860158|NCT01607346|Secondary|Frequency of Micturition as Recorded on the Voiding Diary for 2 Days Prior to Each Visit|The participants were asked to complete a voiding diary for two days preceding each visit. Frequency of micturition for 2 days prior to dach visit was defined as total number of entries recorded within 2 days prior to each post-baseline visit. Voiding diary was assessed at Baseline visit 2 (Day -1) and on visit 3 (Day 21), visit 4 (Day 35), visit 5 (Day 49) and visit 6 (follow-up visit within 14 days after the end-of-treatment eye examination). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline (Day -1) and up to Day 80 (Visit 6)|Safety Population||Micturition voided||Standard Deviation|Mean
860159|NCT01607346|Secondary|Change From Baseline in Average Flow Rate (Qmean) at Visits 3, 4, 5 and 6|Average flow rate was measured by uroflowmetry test. It is a non-invasive diagnostic test that measures the speed of urinary flow. Uroflowmetry was assessed at Baseline visit 2 (Day -1) and on visit 3 (Day 21), visit 4 (Day 35), visit 5 (Day 49) and visit 6 (follow-up visit within 14 days after the end-of-treatment eye examination). Measurement at visit 2 (Day -1) was considered as Baseline value. Change from Baseline was calculated by subtracting the Baseline value from the post-baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline (Day -1) and up to Day 80 (Visit 6)|Safety Population||mL per second||Standard Deviation|Mean
860160|NCT01607346|Secondary|Change From Baseline in Flow Time at Visits 3, 4, 5 and 6|Flow time was measured by uroflowmetry test. It is a non-invasive diagnostic test that measures the speed of urinary flow. Uroflowmetry was assessed at Baseline visit 2 (Day -1) and on visit 3 (Day 21), visit 4 (Day 35), visit 5 (Day 49) and visit 6 (follow-up visit within 14 days after the end-of-treatment eye examination). Measurement at visit 2 (Day -1) was considered as Baseline value. Change from Baseline was calculated by subtracting the Baseline value from the post-baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline (Day -1) and up to Day 80 (Visit 6)|Safety Population||Seconds||Standard Deviation|Mean
860161|NCT01607346|Secondary|Change From Baseline in Time to Maximum Flow at Visits 3, 4, 5 and 6|Time to maximum flow was measured by uroflowmetry test. It is a non-invasive diagnostic test that measures the speed of urinary flow. Uroflowmetry was assessed at Baseline visit 2 (Day -1) and on visits 3 (Day 21), visit 4 (Day 35), visit 5 (Day 49) and visit 6 (follow-up visit within 14 days after the end-of-treatment eye examination). Measurement at visit 2 (Day -1) was considered as Baseline value. Change from Baseline was calculated by subtracting the Baseline value from the post-baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline (Day -1) and up to Day 80 (Visit 6)|Safety Population||Seconds||Standard Deviation|Mean
860162|NCT01607346|Secondary|Change From Baseline in Voided Volume (VV) at Visits 3, 4, 5 and 6|The volume of urine voided was measured by uroflowmetry test. Uroflowmetry was assessed at Baseline visit 2 (Day -1) and on visits 3 (Day 21), visit 4 (Day 35), visit 5 (Day 49) and visit 6 (follow-up visit within 14 days after the end-of-treatment eye examination). Measurement at visit 2 (Day -1) was considered as Baseline value. Change from Baseline was calculated by subtracting the Baseline value from the post-baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline (Day -1) and up to Day 80 (Visit 6)|Safety Population||mL||Standard Deviation|Mean
860163|NCT01607346|Secondary|Change From Baseline in Percentage Residual Urinary Volume (RUV) at Visits 3, 4, 5 and 6|Percentage residual urinary volume is a standardized measure of post-residual volume and is defined as residual devided by residual plus voided multiplied by 100 where 'residual' is the post-void residual (PVR) volume collected on the bladder ultrasound and 'voided' is the voided volume collected on the uroflowmetry. Measurement at visit 2 (Day -1) was considered as Baseline value. Change from Baseline was calculated as post-baseline minus Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)|Baseline (Day -1) and up to Day 80 (Visit 6)|Safety Population||Percentage of residual urinary volume||Standard Deviation|Mean
860164|NCT01607346|Secondary|Percent Change From Baseline in Qmax at Visits 3, 4, 5 and 6|Maximum urine flow rate was measured by uroflowmetry test. It is a non-invasive diagnostic test that measures the speed of urinary flow. Uroflowmetry was assessed at Baseline visit 2 (Day -1) and on visits 3 (Day 21), visit 4 (Day 35), visit 5 (Day 49) and visit 6 (follow-up visit within 14 days after the end-of-treatment eye examination). Measurement at visit 2 (Day -1) was considered as Baseline value. The percentage change from Baseline was calculated as post-baseline value minus Baseline value divided by Baseline value multiplied by 100. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)|Baseline (Day -1) and up to Day 80 (Visit 6)|Safety Population||Percent change||Standard Deviation|Mean
860165|NCT01607346|Secondary|Change From Baseline in Maximum Flow Rate (Qmax) at Visits 3, 4 and 6|Maximum urine flow rate was measured by uroflowmetry test. It is a non-invasive diagnostic test that measures the speed of urinary flow. Uroflowmetry was assessed at Baseline visit 2 (Day -1) and on visits 3 (Day 21), visit 4 (Day 35), visit 5 (Day 49) and visit 6 (follow-up visit within 14 days after the end-of-treatment eye examination). Measurement at visit 2 (Day -1) was considered as Baseline value. Change from Baseline was calculated by subtracting the Baseline value from the post-baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline (Day -1) and up to Day 80 (Visit 6)|Safety Population||mL per second||Standard Deviation|Mean
860166|NCT01607346|Primary|Change From Baseline in Maximum Flow Rate (Qmax) at Visit 5.|Maximum urine flow rate was measured by uroflowmetry test. It is a non-invasive diagnostic test that measures the speed of urinary flow. Uroflowmetry was assessed at Baseline visit 2 (Day -1) and on visits 3, 4 and 5 (Days 21, 35 and 49 respectively). Measurement at visit 2 (Day -1) was considered as Baseline value. Change from Baseline was calculated by subtracting the Baseline value from the post-baseline value at Visit 5. Safety Population was defined as all participants who received more than or equal to one dose of study medication.|Baseline (Day -1) and on Day 49 (Visit 5)|Safety Population||Milliliter (mL) per second||Standard Deviation|Mean
860167|NCT01572389|Primary|Change in Patient Health Questionnaires-9 During Intervention|"The Patient Health Questionnaires-9 assesses depressive symptoms during the course of the intervention. The PHQ-9 ranges in score from 0 - 27; where higher numbers represent increase levels of depression. Scores from 5 - 9 represent minimal symptoms of depression; 10 - 14 represent minor depression, dysthymia, or major depression - mild; 15 - 19 represent major depression, moderately severe; and scores of 20 and above is considered major depression, severe. Participants with that scored a 10 or above were eligible for the study."|PHQ-9 will be assessed at baseline, 6-, and 12- months.|The number analyzed at each timepoint decreased due to non-completion of the assessment by participants.||units on a scale||Standard Deviation|Mean
860168|NCT01572389|Primary|Change in Hemoglobin A1C|Measures of Hemoglobin A1C will be taken to assess average blood glucose levels throughout the study as an indicator of diabetes control. Hemoglobin A1C is a blood test taken to assess average blood glucose levels in the body. Normal range of A1C level is below 5.7. Eligible participants had an A1C of 7.5 or higher. The higher the A1C the more a person's diabetes is uncontrolled.|Hemoglobin A1C levels will be measured at baseline, 6-, and 12- months.|The number analyzed at each timepoint decreased due to non-completion of the A1C blood draw by participants.||percentage of glycated hemoglobin||Standard Deviation|Mean
860169|NCT01557166|Secondary|Change From Baseline in Glycosylated Haemoglobin (HbA1c) (%)|Observed mean change from baseline in glycosylated haemoglobin (HbA1c) (%) after 32 weeks of treatment.|Week 0, week 32|Full analysis set (FAS) - included all randomised subjects. 345 subjects contributed to the statistical analysis||percentage of glycosylated haemoglobin||Standard Deviation|Mean
860170|NCT01557166|Secondary|Change From Baseline in Fasting Plasma Glucose|Observed mean change from baseline in fasting plasma glucose (mmol/L) after 32 weeks of treatment.|Week 0, week 32|Full analysis set (FAS) - included all randomised subjects. 355 subjects contributed to the statistical analysis.||mmol/L||Standard Deviation|Mean
860171|NCT01557166|Secondary|Change From Baseline in Body Weight (kg)|Observed mean change from baseline in fasting body weight (kg) after 32 weeks of treatment.|Week 0, week 32|Full analysis set (FAS) - included all randomised subjects. 353 subjects contributed to the statistical analysis.||kg||Standard Deviation|Mean
860172|NCT01557166|Primary|Change From Baseline in Apnoea-hypopnoea Index (AHI)|Observed mean change from baseline in AHI (events/hour) after 32 weeks of treatment. AHI (apnoea and hypopnoea events per hour of sleep) is a measure used for the diagnosis and severity classification of obstructive sleep apnoea. AHI severity category: none ≤4.9; mild 5.0−14.9; moderate 15.0−29.9; severe ≥30.0 events/hour.|Week 0, Week 32|Full analysis set (FAS) - included all randomised subjects. 334 subjects contributed to the statistical analysis.||events/hour||Standard Deviation|Mean
860173|NCT01496846|Secondary|Anesthetic Success Rate of an IANB With Articaine|Success rate of an IANB with articaine using a conventional IANB technique|15 min after injection|"All enrolled participants (N=201) received an IANB with Articaine. Two participants were excluded from data analysis due to inadequate lip numbness (IANB was considered missed block); thus N=199 were analyzed for success rate."||Participants|||Count of Participants
860174|NCT01496846|Primary|Anesthetic Success Rate of Supplemental Infiltration Injection|Following an unsuccessful IANB, supplemental infiltration anesthesia with either articaine or lidocaine was given to achieve complete pulpal anesthesia|5 min after injection|||Participants|||Count of Participants
860175|NCT01454076|Primary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Ixazomib||Arm 1:Days 1, 15 and Arm 5:Day 6 pre-dose and at multiple time points(up to 264 hrs)post-dose;Arm 2, 3:Days 1,15 pre-dose and at multiple time points(up to 216 hrs)post-dose;Arm 4:Day 8 pre-dose and at multiple time points(up to 168 hrs)post-dose|The PK-evaluable population included all participants who received protocol-specified dose in Cycle 1 without dose reductions/interruptions, did not receive any excluded concomitant medication during PK sampling, and had sufficient concentration-time data to permit estimation of PK parameters by noncompartmental analysis methods.||hours||Full Range|Median
860176|NCT01454076|Secondary|Percentage of Participants With Best Overall Response|Best overall response for a participant is best observed post-baseline disease response as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1: Complete response (CR) was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than (<) 10 millimeter [mm]). No new lesions. Partial response (PR) was defined as greater than or equal to (>=) 30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. Stable disease (SD) was defined as not qualifying for CR, PR, Progressive Disease (PD). An increase of >=20% from the nadir (or baseline, if it represents the point at which the sum of target disease was lowest) represents PD.|Baseline up to end of treatment (approximately 1.9 years)|The response-evaluable population included participants who had measurable disease at baseline, received at least 1 dose of any study drug, and had at least 1 postbaseline response assessment.||percentage of participants||95% Confidence Interval|Number
860180|NCT01454076|Primary|AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Ixazomib||Arm 1:Days 1, 15 and Arm 5:Day 6 pre-dose and at multiple time points(up to 264 hrs)post-dose;Arm 2, 3:Days 1,15 pre-dose and at multiple time points(up to 216 hrs)post-dose;Arm 4:Day 8 pre-dose and at multiple time points(up to 168 hrs)post-dose|The PK-evaluable population included all participants who received protocol-specified dose in Cycle 1 without dose reductions/interruptions, did not receive any excluded concomitant medication during PK sampling, and had sufficient concentration-time data to permit estimation of PK parameters by noncompartmental analysis methods.||nanogram*hour per milliliter (ng*hr/mL)]||Standard Deviation|Geometric Mean
860181|NCT01454076|Primary|Cmax: Maximum Observed Plasma Concentration for Ixazomib||Arm 1:Days 1, 15 and Arm 5:Day 6 pre-dose and at multiple time points(up to 264 hours[hrs])post-dose;Arm 2, 3:Days 1,15 pre-dose and at multiple time points(up to 216 hrs)post-dose;Arm 4:Day 8 pre-dose and at multiple time points(up to 168 hrs)post-dose|The pharmacokinetic (PK)-evaluable population included all participants who received protocol-specified dose in Cycle 1 without dose reductions/interruptions, did not receive any excluded concomitant medication during PK sampling, and had sufficient concentration-time data to permit estimation of PK parameters by noncompartmental analysis methods.||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
860182|NCT01416584|Other Pre-specified|Entered Methadone Treatment|Did the participant enter methadone treatment at any point in the 6-month treatment period?|6 months|We did not analyze this measure. This grant has ended and there is no funding to conduct more analyses.|||||
860183|NCT01416584|Other Pre-specified|In Methadone Treatment at End of Treatment|Was each participant in methadone treatment at the end of the 6-month intervention evaluation period?|6 months|We did not analyze this measure. This grant has ended and there is no funding to conduct more analyses.|||||
860184|NCT01416584|Other Pre-specified|Did Participant Inject Drugs?|Percent of months that participants reported injecting drugs.|6 months|We did not analyze this measure. This grant has ended and there is no funding to conduct more analyses.|||||
860185|NCT01416584|Other Pre-specified|Went to Shooting Gallery/House or Other Place Where Users go to Shoot-up?|The percent of months that participants reported going to a shooting gallery/hour or other place where users go to shoot-up.|6 months|Due to the very low rate of reports of going to a shooting gallery/house or other place where users go to shoot-up in all groups, we did not analyze this measure. This grant has ended and there is no funding to conduct more analyses.|||||
860186|NCT01416584|Other Pre-specified|Did Participant Share Needles or Works?|Percent of months that participants reported sharing needles or works.|6 months|Due to the very low rate of reports of sharing needles or works in all groups, we did not analyze this measure. This grant has ended and there is no funding to conduct more analyses.|||||
860187|NCT01416584|Secondary|Percentage of M,W,F Urine Samples Negative for Opiates|Was each participant's urine sample negative for opiates at each of the Monday, Wednesday, Friday urine samples scheduled throughout the intervention evaluation period?|6 months|intent to treat||percentage of M,W,F urine samples||Full Range|Mean
860188|NCT01416584|Secondary|Percentage of M,W,F Urine Samples Negative for Cocaine|Was each participant's urine sample negative for cocaine at each of the Monday, Wednesday, Friday urine samples scheduled throughout the intervention evaluation period?|6 months|intent to treat||percentage of urine samples||Full Range|Mean
860189|NCT01416584|Primary|Percentage of Monthly Urine Samples Negative for Cocaine|Was the participant's urine sample negative for cocaine at each of the six 30-day assessments scheduled throughout the intervention evaluation period?|6 months|intent to treat||percentage of cocaine negative||Full Range|Mean
860190|NCT01416584|Primary|Percentage of Monthly Urine Sample Negative for Opiates|Percentage of urine sample negative for opiates at each of the six 30-day assessments scheduled throughout the intervention evaluation|6 months|Intent to treat||percentage of opiate negative||Full Range|Mean
860191|NCT01416584|Primary|Percentage of Months in Methadone Treatment|The percentage of months in which participants were enrolled in methadone treatment during the 6-month intervention evaluation period?|6 months|Intent to treat||percent of months in methadone treatment||Full Range|Mean
860192|NCT01415232|Primary|Correlation Between Actual Epidural Needle Depth (ND) and Estimated Epidural Depth (Est-D)|Measured using the Pearson correlation coefficient between actual epidural needle depth (ND) and epidural depth as estimated by the epidural depth equation (EQ-US) followed by ultrasound (longitudinal and transverse planes) measurement.|at the time of labor epidural catheter insertion (an average of 5 minutes for ultrasound visualization)|per protocol||correlation coefficient||95% Confidence Interval|Number
860193|NCT01371110|Secondary|Percentage of Patients Who Meet Response and Remission|Percentage of patients who meet response (defined as 25% reduction in Y-BOCCS score) and remission (defined as Y-BOCS score ≤10) criteria at 24 hrs post-infusion and durability of efficacy up to two weeks after administration. Assessments will be performed 24, 48 and 72 hrs post-infusion and after 7, 10, and 14 days.|up to 14 days|||percentage of participants|||Number
860194|NCT01371110|Primary|Change in Yale-Brown Obsessive Compulsive Scale (Y-BOCCS) Rating OCD Symptom Severity From Baseline to 24-hours After Ketamine Administration|"The primary efficacy outcome is change in the Y-BOCCS rating score on a scale from baseline to 24 hrs post-administration of ketamine.
The 10 Y-BOCCS items are each scored on a four-point scale from 0 = no symptoms to 4 = extreme symptoms. The sum of the first five items is a severity index for obsessions. The sum of the last five an index for compulsions. A translation of total score into an approximate index of overall severity is: 0-7 - subclinical; 8-15 - mild; 16-23 - moderate; 24-31 - severe; 32-40 - extreme."|Baseline and 24 Hours|||Units on a scale||Full Range|Mean
860195|NCT01344824|Secondary|Subjects Experiencing Toxicity|Toxicity will be evaluated using CTCAE criteria, version 3, all grade 3 and 4 events.|90 days|All patients who received treatment were evaluated||participants|||Number
860196|NCT01344824|Secondary|Overall Survival|Time of enrollment to date of death.|1400 days|||months||95% Confidence Interval|Median
860197|NCT01344824|Primary|Progression-free Survival|Documented radiographic response per Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by imaging: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. criteria each year, until subject death|1400 days|||months||95% Confidence Interval|Median
860198|NCT01313676|Secondary|Number of Participants With First On-treatment Cardiovascular (CV) Composite Events Occured on or Before Common End Date|On-treatment CV composite event is comprised of the first event that is adjudicated as on-treatment CV death, myocardial infarction, stroke, unstable angina, or transient ischemic attack experienced by a participant. The events that occurred no more than 7 days after the participants last dose of IP are considered as on-treatment adverse events. Common end date is the study end date where approximately 1000 deaths would have occurred in the ITT-E Population. Cox PH Model was used to assess time to first on-treatment CV composite event. Cox PH Model was adjusted for age, gender and indicators of ischemic and vascular disease, including all four treatment arms. A hazard ratio less than 1 indicates a lower risk of a first CV event rate versus placebo or any arm.|From the start of IP to first on treatment CV event till 7 days after the last dose of IP (average of 2 study years)|ITT-E Population||Participants|||Number
860199|NCT01313676|Secondary|Decline in Forced Expiratory Volume in 1 Second (FEV1)|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The effect of treatment on decline of post bronchodilator FEV1 recorded during the treatment period was analyzed using a particular form of a mixed effect model - a random coefficients model. FEV1 was fitted as the response variable with treatment group, age, gender, baseline FEV1 and time on treatment as fixed effects. Time on treatment was treated as a continuous variable. This model allowed for an initial increase in FEV1, but then tested the difference in slopes from the first post-baseline measurement which was at 3 months. A negative slope indicates a decline. A positive treatment difference indicates a slower rate of decline vs Placebo or Component. Only participants with at least one on-treatment post-bronchodilator FEV1 measurement were analyzed.|From start date of IP until IP stop date + 1 (assessed up to 4 years)|ITT-E Population||milliliter/year||Standard Error|Least Squares Mean
860200|NCT01313676|Primary|Number of Participants With Death (Both on and Off Treatment) Due to Any Cause, Time up to or on the Pre-determined Common End Date|Death from any cause: which occurred from the day of starting IP until the Commone End Date (CED). Common End Date (CED) is the study end date that was pre determined where approximately 1000 deaths would have occurred in the Intent-toTreat Efficacy (ITT-E) Population. Only deaths which occurred on or before the CED were used for the primary analysis. Those who had not died by CED, but who were known to be alive on or after the CED, were censored at the CED. Cox Proportional Hazards (PH) Model was adjusted for age, and gender, including all 4 arms. A hazard ratio of less than 1 indicates a lower death rate versus placebo or other arm. ITT-E Population consisted of all participants in the Safety Population (i.e. randomized to IP and who received at least one dose of IP), with the exception of those recruited at sites that were closed.|From the date of randomization until date of death due to any cause (average of 2 study years)|ITT-E Population||Participants|||Number
860201|NCT01284504|Secondary|Surveys to Evaluate Patient Pain, Fatigue, and Quality of Recovery, Recorded From Day of Surgery to 30 Days Post-op.||30 days||||||
860202|NCT01284504|Primary|Blood Samples Taken Before Initiation of Study, Day of Surgery, Days 1 and 3 Post-op, and 30 Days Post-op. Analyzed for 50 Serum Cytokines, Cell-specific Gene Expression, and TCR Repertoire.||2 years||||||
860203|NCT01284504|Primary|Tumor Sample - Analyzed for TCR Repertoire and Global Transcription Profiling|One patient was accrued and withdrawn after signing consent; None was treated.|2 years||||||
860204|NCT01272232|Secondary|Incidence of Hypoglycaemic Episodes|Hypoglycaemic episodes were classified according to American Diabetes Association (ADA) definitions as well as to the Novo Nordisk definition of a minor hypoglycaemic event (blood glucose level below approximately 2.8 mmol/L [50 mg/dL] or plasma glucose level below 3.1 mmol/L [56 mg/dL]).|Weeks 0-56|Safety analysis set, comprising all randomised subjects who had been exposed to at least one dose of trial product.||Episodes/100 years of patient exposure|||Number
860205|NCT01272232|Secondary|Change From Week 56 to 68 in Waist Circumference||Week 56, week 68|Last Observation Carried Forward (LOCF) data. Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.||cm||Standard Deviation|Mean
860206|NCT01272232|Secondary|Change From Baseline in Waist Circumference||Week 0, week 68|Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.||cm||Standard Deviation|Mean
860207|NCT01272232|Secondary|Change (%) From Week 56 to 68 in Body Weight (Fasting)|Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial.|Week 56, week 68|Last Observation Carried Forward (LOCF) data. Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.||percent change||Standard Deviation|Mean
860208|NCT01272232|Secondary|Change (%) From Baseline in Body Weight (Fasting)|Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial.|Week 0, week 68|Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.||percent change||Standard Deviation|Mean
860209|NCT01272232|Secondary|Change From Baseline in Waist Circumference||Week 0, week 56|Last Observation Carried Forward (LOCF) data. Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.||cm||Standard Deviation|Mean
860210|NCT01272232|Secondary|Proportion of Subjects Reaching Target HbA1c Below or Equal to 6.5%||at 56 weeks|Last Observation Carried Forward (LOCF) data. Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.||percentage of subjects|||Number
860211|NCT01272232|Secondary|Proportion of Subjects Reaching Target HbA1c Below 7%||at 56 weeks|Last Observation Carried Forward (LOCF) data. Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.||percentage of subjects|||Number
860255|NCT01142297|Primary|Implant Stability Quotient (ISQ)|resonance frequency analysis employed to determine implant stability quotient on a 1-100 point scale with 100 representing the greatest stability.|4 months|||units on a scale||Standard Error|Mean
860213|NCT01272232|Primary|Proportion of Subjects Losing More Than 10% of Baseline Body Weight|Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial.|at 56 weeks|Last Observation Carried Forward (LOCF) data. Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.||percentage of subjects|||Number
860214|NCT01272232|Primary|Proportion of Subjects Losing at Least 5% of Baseline Body Weight|Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial.|at 56 weeks|Last Observation Carried Forward (LOCF) data. Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.||percentage of subjects|||Number
860215|NCT01272232|Primary|Change (%) From Baseline in Body Weight (Fasting)|Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial.|Week 0, week 56|Last Observation Carried Forward (LOCF) data. Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.||percent change||Standard Deviation|Mean
860216|NCT01272219|Secondary|Change From Baseline in Fasting Body Weight (%) (Re-randomised Subjects With No Pre-diabetes)|The observed mean change from baseline in fasting body weight (%) in re-randomised subjects (with no pre-diabetes at baseline) after 68 weeks of treatment (main + re-randomised treatment period).|Week 0, Week 68|The FAS included all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and who provided at least one post-baseline efficacy value. Missing data were imputed using LOCF.||percent change||Standard Deviation|Mean
860217|NCT01272219|Secondary|Change From Week 56 in Fasting Body Weight (%) (Re-randomised Subjects With No Pre-diabetes)|The observed mean change in fasting body weight (%) from week 56 to week 68 in re-randomised subjects (with no pre-diabetes at baseline) after 12-weeks of treatment (re-randomised treatment period).|Week 56, Week 68|The FAS included all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and who provided at least one post-baseline efficacy value. Missing data were imputed using LOCF.||percent change||Standard Deviation|Mean
860218|NCT01272219|Secondary|Proportion of Subjects Losing at Least 5% and Proportion of Subjects Losing More Than 10% of Baseline Fasting Body Weight (Subjects With Pre-diabetes at Baseline)|Percentage of subjects losing >=5% and percentage of subjects losing >10% of baseline fasting body weight (pre-diabetic subjects at baseline) after 160-weeks of treatment (main + extension treatment period). Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period).|At 160 weeks|Subjects included in the FAS, who were stratified to 160-weeks of treatment; all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and with at least one post-baseline efficacy measurement, who were stratified to 160-weeks of treatment. Missing data were imputed using LOCF.||percentage of subjects|||Number
860219|NCT01272219|Secondary|Mean Change From Baseline in Fasting Body Weight (Subjects With Pre-diabetes at Baseline)|The observed mean change from baseline in fasting body weight (subjects with pre-diabetes at baseline) after 160 weeks of treatment (main + extension treatment period). Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period).|Week 0, week 160|Subjects included in the FAS, who were stratified to 160-weeks of treatment; all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and with at least one post-baseline efficacy measurement, who were stratified to 160-weeks of treatment. Missing data were imputed using LOCF.||percent change||Standard Deviation|Mean
860220|NCT01272219|Secondary|Pre-diabetes Status in Subject With Pre-diabetes at Baseline After 160 Weeks of Treatment|Observed percentage of subjects (subjects with pre-diabetes at baseline) with pre-diabetes status after 160 weeks of treatment (main + extension treatment period). Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period).|Week 0, week 160|Subjects included in the FAS, who were stratified to 160-weeks of treatment; all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and with at least one post-baseline efficacy measurement, who were stratified to 160-weeks of treatment. Missing data were imputed using LOCF.||percentage of subjects|||Number
860221|NCT01272219|Secondary|Pre-diabetes Status After 56 Weeks of Treatment|Observed percentage of subjects with pre-diabetes status after 56 weeks of treatment (main treatment period).|Week 0, Week 56|The FAS included all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and who provided at least one post-baseline efficacy value. Missing data were imputed using LOCF.||percentage of subjects|||Number
860222|NCT01272219|Secondary|Change From Baseline in Waist Circumference (Subjects With Pre-diabetes at Baseline)|The observed mean change from baseline in waist circumference (subjects with pre-diabetes at baseline) after 160 weeks of treatment (main + extension treatment period). Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period).|Week 0, week 160|Subjects included in the FAS, who were stratified to 160-weeks of treatment; all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and with at least one post-baseline efficacy measurement, who were stratified to 160-weeks of treatment. Missing data were imputed using LOCF.||cm||Standard Deviation|Mean
860256|NCT01108445|Other Pre-specified|Changes in Copy Number, RNA Expression, and Immunohistochemical Profiles|To evaluate in an exploratory fashion changes in copy number, RNA expression, and immunohistochemical profiles by microarray between primary non-clear cell RCC tumors and metastatic samples|36 months||||||
860223|NCT01272219|Secondary|Change From Baseline in Waist Circumference (cm)|The observed mean change from baseline in waist circumference (cm) after 56-weeks of treatment (main treatment period).|Week 0, Week 56|The FAS included all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and who provided at least one post-baseline efficacy value. Missing data were imputed using LOCF.||cm||Standard Deviation|Mean
860224|NCT01272219|Primary|Proportion of Subjects With Onset of Type 2 Diabetes|Proportion of subjects with onset of Type 2 diabetes mellitus (T2DM) at week 160 (main + extension treatment period) among subjects with pre-diabetes at baseline - evaluated as time to onset of T2DM. Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period).|At 160 weeks|Subjects included in the FAS, who were stratified to 160-weeks of treatment; all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and with at least one post-baseline efficacy measurement, who were stratified to 160-weeks of treatment. Missing data were imputed using LOCF.||Subject|||Number
860225|NCT01272219|Primary|Proportion of Subjects Losing More Than 10% of Baseline Fasting Body Weight|Percentage of subjects losing >10% of baseline fasting body weight after 56-weeks of treatment (main treatment period).|At 56 weeks|The FAS) included all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and who provided at least one post-baseline efficacy value. Missing data were imputed using LOCF.||percentage of subjects|||Number
860226|NCT01272219|Primary|Proportion of Subjects Losing at Least 5% of Baseline Fasting Body Weight.|Percentage of subjects losing at least 5% of baseline fasting body weight after 56-weeks of treatment (main treatment period).|At Week 56|The FAS included all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and who provided at least one post-baseline efficacy value. Missing data were imputed using LOCF.||percentage of subjects|||Number
860227|NCT01272219|Primary|Change From Baseline in Fasting Body Weight|The observed mean change from baseline in fasting body weight (%) after 56-weeks of treatment (main treatment period).|Week 0, Week 56|The full analysis set (FAS) included all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and who provided at least one post-baseline efficacy value. Missing data were imputed using last observation carried forward (LOCF).||percent change||Standard Deviation|Mean
860228|NCT01263717|Secondary|Hemostatic Markers|Tissue plasminogen activator (tPA) and plasminogen activator inhibitor-1 (PAI-1) measured in serum.|6 months|Please note that we do not have data for these markers (neither PAI1 or tPA) because we did not have adequate funds to assess these.|||||
860229|NCT01263717|Secondary|Adiponectin|adiponectin.|6 months|All available data were used. Data were not available for 1 subject.||Change in ng/mL||Inter-Quartile Range|Median
860230|NCT01263717|Secondary|Glucose Tolerance|Glucose tolerance as measured by standard oral glucose tolerance test. 2-hour glucose is given.|6 months|All available data were used; data were not available for some subjects.||Change in 2-hour glucose, mg/dL||95% Confidence Interval|Mean
860231|NCT01263717|Secondary|Carotid Intimal Medial Thickness (cIMT)|Carotid Intimal Medial Thickness (cIMT).|6 months|All available data were used.||Change in mm||95% Confidence Interval|Mean
860232|NCT01263717|Secondary|Lipid Panel|Fasting lipids. Triglyceride value is given.|6 months|All available data were used; data were not available for one subject.||Change in triglyceride, mg/dL||Inter-Quartile Range|Median
860233|NCT01263717|Secondary|Insulin Like Growth Factor 1 (IGF-I)|Insulin Like Growth Factor 1 (IGF-I).|6 months|All available data were used; data were not available for one subject.||Change in ng/mL||Standard Deviation|Mean
860234|NCT01263717|Secondary|HbA1c|Hemoglobin A1c.|6 months|All available data were used; data were not available for one subject.||Change in %||95% Confidence Interval|Mean
860235|NCT01263717|Secondary|Insulin Sensitivity|In a subgroup of 1/2 of the subjects, euglycemic hyperinsulinemic clamp will be performed to assess insulin-stimulated glucose uptake. Insulin stimulated glucose uptake (M) calculated using the method of DeFronzo is shown.|6 months|All available data were used; data were not available for some subjects.||Change in mg/kg/min||95% Confidence Interval|Mean
860236|NCT01263717|Secondary|Endogenous Growth Hormone Secretion|Endogenous growth hormone (GH) concentrations measured by overnight frequent blood sampling every 20 minutes. Mean overnight GH concentration is given.|6 months|All available data were used; data were not available for some subjects.||Change in ng/mL||Inter-Quartile Range|Median
860237|NCT01263717|Secondary|Intramyocellular Lipid|Intramyocellular lipid (IMCL) as measured by magnetic resonance (MR) spectroscopy of the calf. Soleus IMCL normalized to creatinine (IMCL/Cr based on areas determined by spectroscopy) was measured. The change over 6 months is reported.|6 months|All available data were used; data were not available for some subjects. Data from 1 patient who was discontinued between the 3 and 6mo visits for adverse event are included. These data were obtained at a termination visit.||Change in ratio of IMCL/Cr||Inter-Quartile Range|Median
860238|NCT01263717|Primary|Visceral Adipose Tissue|Change in visceral adipose tissue area as measured by single-slice computed tomography (CT) scan at the L4 vertebra.|6 months|Data from 1 patient who was discontinued between the 3 and 6mo visits for adverse event are included. These data were obtained at a termination visit.||change in cm^2 after 6 months||95% Confidence Interval|Mean
860239|NCT01263717|Primary|Liver Fat|Hepatic fat as measured by magnetic resonance (MR) spectroscopy, and expressed by normalizing lipid to water and expressing as a percent (lipid-to-water percent).|6 months|All available data were used; data were not available for some subjects. Data from 1 patient who was discontinued between the 3 and 6mo visits for adverse event are included. These data were obtained at a termination visit.||Change in hepatic lipid-to-water %||Inter-Quartile Range|Median
860257|NCT01108445|Secondary|Change in Quality-of-life|To compare change in quality-of-life, as measured by the FACT-KSI scale at baseline and end of treatment per subject in each treatment arm. Functional Assessment of Cancer Therapy Kidney Symptom Index. FKSI is a questionnaire for FACT–Kidney Symptom Index used to assess QoL/participant-reported outcomes for participants diagnosed with renal cell cancer. The FKSI contained 15 questions each ranging from 0 (not at all) to 4 (very much) so that FKSI ranged between 0-60 where higher scores reflects better functioning and fewer symptoms.|baseline, up to 40 months|All participants who completed the End of treatment visit.||units on a scale||Standard Deviation|Mean
860240|NCT01243762|Secondary|Number of Participants Whose Best Response is a Partial Response (PR) or Complete Response (CR)|Best response was determined for the maximum tolerated dose from the start of treatment until disease progression, recurrence, or completion of 6 months of treatment. Lesions were measured by computed tomography (CT) scan or magnetic resonance imaging (MRI). Partial response (PR), defined as a tumor burden decrease of 30%, or complete response (CR) was determined using Response Criteria in Solid Tumors (RECIST) 1.1 for participants with at least one measurable target lesion at baseline.|Up to 7 months|All participants who received at least one dose of study therapy and had baseline data for those analyses that required baseline data. The analysis was planned to be performed on the 3 arms in Part 2 only. The study was terminated prior to completion of this analysis.||Participants|||Number
860241|NCT01243762|Primary|Number of Participants With Dose-limiting Toxicities (DLTs)|DLTs were defined as follows: 1) non-hematological toxicity ≥Grade 3 according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 except for Grade 3 nausea, vomiting, diarrhea, and/or dehydration; Grade 3 or 4 hyperglycemia; alopecia; inadequately treated hypersensitivity reactions; dalotuzumab infusion-related reactions; Grade 3 transaminases ≤1 week in duration; or clinically non-significant, treatable or reversible lab abnormalities; 2) Grade 4-5 hematologic toxicity, with the exception of Grade 4 neutropenia <6 days in duration; 3) Grade 3 or Grade 4 neutropenia with fever >38.5 degrees C; 4) Grade 4 thrombocytopenia ≤25.0 x 10^9/Liter; 5) drug-related adverse experience leading to a dose modification during Cycle 1; 6) unresolved drug-related toxicity that causes ≥3 week delay of the next scheduled dose of study medication; 7) persistent increases in QTc interval >60 milliseconds from baseline, or clinically significant bradycardia.|Cycle 1-28 Days|All participants who received at least one dose of study therapy in Cycle 1||Participants|||Number
860242|NCT01234831|Secondary|Rate of Recolonization or Documented Infection With MRSA|Prospective review of microbiological data for patients enrolled in the trial to determine rate of recolonization or documented infection. Subjects in the Intervention Arm of the study who had documented clearance of colonization and met criteria for discontinuation of contract precautions, and had CP discontinued by staff (N=69) were included. Subjects who had a visit at MGH through 12/31/2012 during which a microbiology sample was obtained and MRSA was recovered (clinical or surveillance) were included.|2 years|We reviewed the data on the 69 subjects who were enrolled in the intervention arm of the trial who were cleared of colonization based on the study intervention.||Participants|||Count of Participants
860243|NCT01234831|Secondary|Specificity of First PCR Assay.|Specificity of the first PCR assay for subjects enrolled in active arm of trial.|1 year|||percentage of true negatives||95% Confidence Interval|Number
860244|NCT01234831|Secondary|Sensitivity of First PCR Assay|Sensitivity of the first PCR assay for subjects enrolled in active arm of trial.|1 year|||percentage of true positives||95% Confidence Interval|Number
860245|NCT01234831|Secondary|Number of Subjects With a Single Positive PCR Result and at Least 1 Positive Culture Assay|This outcome is the positive predictive value of a single PCR assay for subjects with a history of prior MRSA infection or colonization who completed the 3 swab protocol.|1 year|Number of participants in the Active Screening arm who had completed the 3-swab protocol.||participants|||Number
860246|NCT01234831|Primary|Discontinuation of Contact Precautions in Both Trial Arms|"Patients known to have MRSA require Contact Precautions based on current recommendations from the Center for Disease Control and Prevention (CDC). Contact Precautions mean that hospitalized patients with a history of MRSA infection or colonization are isolated in a private room or together with patients who have the same Contact Precautions status (i.e. both with MRSA). Healthcare workers caring for such patients must wear protective gowns and gloves during interactions and use of equipment dedicated to that patient is recommended. For this study, Contact Precautions are discontinued refers to the practice of discontinuation of Contact Precautions once subjects meet criteria based on institutional infection control policy: history of MRSA but no positive culture in preceding 90 days and three negative nasal surveillance cultures obtained at least 24 hours apart in the absence of concurrent antibiotic use."|1 year|Analysis was performed on patients in both the Active Screening arm and Passive Screening arm who had completed the 3-swab protocol and all 3 swabs were negative.||percentage of MRSA CP discontinued|||Number
860247|NCT01234831|Primary|Completion of Screening Protocol in Both Trial Arms|Rate at which subjects in both trial arms complete the 3-swab protocol.|1 year|Participants in both the Active Screening arm and Passive Screening arm who completed the 3-swab protocol.||percentage of subjects completed 3 swabs|||Number
860248|NCT01234831|Primary|Number of Subjects With Single Negative Polymerase Chain Reaction (PCR) Result and 3 Negative Culture Assays|This outcome is the negative predictive value of a single PCR assay for subjects with a history of prior MRSA infection or colonization.|1 year|Only patients randomized to the Active Screening arm who had 3 pairs of completed nasal swabs could be analyzed for this outcome measure which is the negative predictive value of the first PCR sample compared to three culture samples for subjects with a history of prior MRSA infection or colonization.||percentage of participants||95% Confidence Interval|Number
860249|NCT01200355|Secondary|To Compare Overall Survival Rates at 6 Weeks||6 weeks from randomization between the two treatment arms.|||Participants|||Count of Participants
860250|NCT01200355|Secondary|Prophylaxis Failure of Study Medication for Any Reason Between Patients Who Receive Posaconazole and Those Who Receive Micafungin.||2 years|||Participants|||Count of Participants
860251|NCT01200355|Secondary|To Compare the Incidence of Possible, Probable or Proven Invasive Fungal Infections Between Patients Who Receive Posaconazole and Those Who Receive Micafungin During Treatment Phase||2 years|||Participants|||Count of Participants
860252|NCT01200355|Secondary|To Compare the Number of Days on Study Drug Between Patients Who Receive Posaconazole and Patients Who Receive Micafungin.||2 years|Results reflect patients who discontinued prophylaxis for suspected IFI (invasive fungal infection)||days||Inter-Quartile Range|Median
860253|NCT01200355|Primary|Time to Failure|Clinical failure is defined as: 1) need for systemic antifungal therapy (AmBisome) for > 3 consecutive days for presumptive fungal infection, toxicity or intolerance of study medication or 2) death.|2 years|Analysis based on a modified intention-to-treat (mITT) approach, with the use of data from patients who underwent randomization and received 2 or more doses of prophylaxis. Trial designed w/ power to detect absolute differences of ~25% of prophylaxis failure in the two groups with ~ 80% power and a significance level of 5% using a two-tail test.||Days||Inter-Quartile Range|Median
860254|NCT01142297|Secondary|Clinical Success of Implants||1 year||||||
860258|NCT01108445|Secondary|Change in Quality-of-life|To compare change in quality-of-life, as measured by the FACT-KSI scale at baseline and cycle 6 day1 per subject in each treatment arm. Functional Assessment of Cancer Therapy Kidney Symptom Index. FKSI is a questionnaire for FACT–Kidney Symptom Index used to assess QoL/participant-reported outcomes for participants diagnosed with renal cell cancer. The FKSI contained 15 questions each ranging from 0 (not at all) to 4 (very much) so that FKSI ranged between 0-60 where higher scores reflects better functioning and fewer symptoms.|baseline, cycle 6 day 1|All participants who completed the cycle 6 day 1 visit.||units on a scale||Standard Deviation|Mean
860259|NCT01108445|Secondary|Change in Quality-of-life|To compare change in quality-of-life, as measured by the FACT-KSI scale at baseline and cycle 3 day 1 per subject in each treatment arm. Functional Assessment of Cancer Therapy Kidney Symptom Index. FKSI is a questionnaire for FACT–Kidney Symptom Index used to assess QoL/participant-reported outcomes for participants diagnosed with renal cell cancer. The FKSI contained 15 questions each ranging from 0 (not at all) to 4 (very much) so that FKSI ranged between 0-60 where higher scores reflects better functioning and fewer symptoms.|baseline, cycle 3 day 1|All participants who completed the cycle 3 day 1 visit.||units on a scale||Standard Deviation|Mean
860260|NCT01108445|Secondary|Percentage of Participants With Adverse Events|To assess toxicities associated with everolimus or sunitinib using NCI CTC version 4.0 criteria|24 months|||percentage of participants||95% Confidence Interval|Number
860261|NCT01108445|Secondary|Time-to-new Metastatic Disease in Each Treatment Arm|To compare the time-to-new metastatic disease in each treatment arm, defined from the date of first study agent administration to the onset of a new evaluable site of disease, excluding the primary site and all sites documented at baseline|36 months|||months||95% Confidence Interval|Median
860262|NCT01108445|Secondary|Median OS|To compare the median OS in each treatment arm.|Up to 40 months|||months||95% Confidence Interval|Median
860263|NCT01108445|Secondary|Median Duration of Response (CR, PR, and SD)|To compare the median duration of response (CR, PR, and SD) in each treatment arm. According to RECIST 1.1, Complete Response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|24 months|||months||Inter-Quartile Range|Median
860264|NCT01108445|Secondary|Clinical Measures of Response and PFS With Baseline and Time-dependent Levels of Biomarkers|To correlate clinical measures of response and PFS with baseline and time-dependent levels of biomarkers. These biomarkers include plasma angiokine levels, tissue immunohistochemical and genomic profiles, copy number as assessed by array-based comparative genomic hybridization (CGH), and known mutations in non-clear cell RCC|36 months||||||
860265|NCT01108445|Secondary|Best Tumor Shrinkage as a Percentile in Each Arm|To compare the best tumor shrinkage as a percentile in each treatment arm. The percentile change at each follow up visit is calculated by measuring the percentage change in the Sum of lesion measurement from baseline. The best tumor shrinkage is lowest percentile change. A decrease is indicated by a negative percentage.|24 months|||percentile decrease||Inter-Quartile Range|Median
860266|NCT01108445|Secondary|Overall Survival Rates|To compare overall survival (OS) rates at 6, 12, 24, and 36 months and over time in each treatment arm.|6, 12, 24, 36 months|||percentage probability||95% Confidence Interval|Number
860267|NCT01108445|Secondary|12 Week Clinical Benefit Rate as Percentage|Rate of complete or partial response or stable disease by the RECIST 1.1 criteria lasting ≥ 12 weeks prior to progression. Benefit rate is defined as complete response [CR] and partial response [PR] and stable disease [SD] by RECIST 1.1 criteria in each treatment arm. Benefit rate = CR + PR + SD. Complete Response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|Baseline to 36 months|||percentage of particpants||95% Confidence Interval|Number
860268|NCT01108445|Secondary|Percentage of Participants With Stable Disease (SD)|Percentage of participants with stable disease during treatment is defined as stable disease [SD] by RECIST 1.1 criteria as calculated in each treatment arm. Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|Baseline to 36 months|||percentage of participants||95% Confidence Interval|Number
860269|NCT01108445|Secondary|Overall Response Rate|Defined as complete response [CR] and partial response [PR] by RECIST 1.1 criteria in each treatment arm.Overall Response Rate (ORR) = CR + PR. Complete Response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|24 months|||percentage of participants||95% Confidence Interval|Number
860270|NCT01108445|Secondary|PFS Expressed in Months|Progression-free survival (PFS) expressed in months as compared to an historic control (interferon-treated clear cell RCC control arm from the sunitinib phase III study). Progressive disease is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).|24 months|||Months||95% Confidence Interval|Median
860271|NCT01108445|Secondary|Progression Free Survival Rates|6-, 12-, and 24-month rates of PFS in each arm will be compared for each treatment arm. Progressive disease is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).|6, 12 and 24 months|||percentage of participants||95% Confidence Interval|Number
860299|NCT00981149|Primary|Pain.|From zero to 100 with 100 being the worst pain.|1, 3, 6 weeks|||units on a scale||Standard Deviation|Mean
860272|NCT01108445|Primary|Anti-tumor Activity as Measured by Median Progression Free Survival Time|The primary objective will be to compare the anti-tumor activity of everolimus and sunitinib in subjects with mRCC with non-clear cell pathology, as measured by progression-free survival (PFS) following treatment initiation according to RECIST 1.1 criteria. Progressive disease is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).|24 Months|||Months||80% Confidence Interval|Median
860273|NCT01078909|Secondary|Change in Lipid Mediators|0 Participants Analyzed; Lipid mediators were unable to be detected therefore there are no data to report.|1, 2, 3 and 5 days post LPS administration|Lipid mediators were unable to be detected; Data were not collected.|||||
860274|NCT01078909|Primary|Mean Concentrations of CRP Following 5 Months of Treatment||5 months|One individual was removed from the analysis due to having very high RBC EPA+DHA content at study entry (>8%)||mg/dL||95% Confidence Interval|Mean
860275|NCT01078909|Primary|Mean Concentrations of Inflammatory Markers (TNF-alpha and IL-6) Following 5 Months of Treatment||5 months|One individual was removed from the analysis due to having very high RBC EPA+DHA content at study entry (>8%)||pg/mL||95% Confidence Interval|Mean
860276|NCT01036321|Secondary|Biomarkers of Disease Progression - Total Testosterone|Median change from baseline to post intervention. Steroid hormones: pre-treatment (Pre:) versus post treatment (Post:).|Up to 6 weeks|All participants who were randomized to a study arm.||ng/dL||Full Range|Median
860277|NCT01036321|Secondary|Biomarkers of Disease Progression - Sex Hormone-binding Globulin (SHBG)|Median change from baseline to post intervention. Steroid hormones: pre-treatment (Pre:) versus post treatment (Post:).|Up to 6 weeks|All participants who were randomized to a study arm.||nmol/L||Full Range|Median
860278|NCT01036321|Secondary|Biomarkers of Disease Progression - IGF-1|Median change from baseline to post intervention. Steroid hormones: pre-treatment (Pre:) versus post treatment (Post:).|Up to 6 weeks|All participants who were randomized to a study arm.||ng/mL||Full Range|Median
860279|NCT01036321|Secondary|Biomarkers of Disease Progression - Insulin Like Growth Factor (IGF) Binding Protein -3|Median change from baseline to post intervention. Steroid hormones: pre-treatment (Pre:) versus post treatment (Post:).|Up to 6 weeks|All participants who were randomized to a study arm.||mg/L||Full Range|Median
860280|NCT01036321|Secondary|Biomarkers of Disease Progression - Free Testosterone|Median change from baseline to post intervention. Steroid hormones: pre-treatment (Pre:) versus post treatment (Post:).|Up to 6 weeks|All participants who were randomized to a study arm.||pg/ml||Full Range|Median
860281|NCT01036321|Secondary|Biomarkers of Disease Progression - Estradiol|Median change from baseline to post intervention. Steroid hormones: pre-treatment (Pre:) versus post treatment (Post:).|Up to 6 weeks|All participants who were randomized to a study arm.||pmo/L||Full Range|Median
860282|NCT01036321|Secondary|Change in Plasma Concentrations of Isoflavone|Plasma concentrations of isoflavone: Genistein from baseline to post intervention by study arm.|Up to 6 weeks|All participants who were randomized to a study arm.||mg||Full Range|Median
860283|NCT01036321|Secondary|Biomarkers of Disease Progression - Serum PSA|Median change from baseline to post intervention: Prostatic specific antigen (PSA). All Participants (ALL); Caucasian Men only (CM only); African American Men only (AAM only).|Up to 6 weeks|All participants who were randomized to a study arm.||ng/mL||Full Range|Median
860284|NCT01036321|Primary|Number of Toxicity Events by Final Attribution and Treatment Arm|Safety: Incidence of Adverse Events (AEs) occurring during intervention with either 20 mg purified isoflavones bid or placebo. Serious Adverse Event (SAEs) and other Adverse Event (AE) details are also reported in the Adverse Event sections.|Up to 6 weeks|All participants who were randomized to a study arm.||Toxicity Events|||Number
860285|NCT01036321|Primary|Median Change in Percent Ki-67 From Baseline|Efficacy: Change in percent Ki-67 evaluated in prostate cancer (PCa) tissue specimens after 3-6 weeks of intervention with purified isoflavones (40 mg daily) vs. Placebo.|Baseline to post intervention - up to 6 weeks|All participants who were randomized to a study arm.||percentage of tumor cells||Full Range|Median
860286|NCT01014533|Secondary|Relapse to Any Drinking|Relapse to any drinking is counted as participants who drank any beverage alcohol from end of sleep laboratory study (night 10) to twelve weeks later|12 weeks|||Participants|||Count of Participants
860287|NCT01014533|Primary|Changes in Sleep Laboratory Recordings Pre- and Post- Study Medication (WASO)|Wake time after sleep onset (WASO) (number of minutes awake throughout the night after initial sleep onset)|1 week|||minutes||Standard Deviation|Mean
860288|NCT01014533|Primary|Changes in Sleep Laboratory Recordings Pre- and Post-study Medication (Stage 2 Percent)|Electrophysiological measures of sleep stages: percent of total sleep time in stage 2 sleep|1 week|||percentage of total sleep time||Standard Deviation|Mean
860289|NCT01000506|Secondary|Mean Change From Baseline in Asthma Control Questionnaire (ACQ) Score Over the 52-week Treatment Period|The ACQ-6 is a six-item questionnaire. The six questions enquire about the frequency and/or severity of symptoms (nocturnal awakening on waking in the morning, activity limitation, shortness of breath, wheeze) and use of short-acting bronchodilator over the previous week. The response options for all these questions consist of a 0 (no impairment/limitation) to 6 (total impairment/ limitation) scale. The overall ACQ score is calculated as the mean of the 6 questions and therefore ranges between 0 (totally controlled) and 6 (severely uncontrolled). Change from BL is defined as the difference between the value of the endpoint at the time point of interest and BL value. Analysis was performed using mixed model repeated measures with covariates of BL, region, BL maintenance OCS therapy (OCS vs. no OCS), exacerbations in the year prior to the study (as an ordinal variable), BL % predicted FEV1, treatment and visit, plus interaction terms for visit by BL and visit by treatment group.|From Baseline up to Week 52 or EW|ITT Population. Only those participants available at the specified time points were analyzed for each treatment and represented as n=X, X, X, X respectively.||Scores on a scale||Standard Error|Least Squares Mean
860310|NCT00950300|Secondary|Tmax of Trastuzumab After Surgery|PK samples were obtained after surgery (Cycle 12). The Tmax during Cycle 12 was recorded, averaged among all participants, and expressed in days.|Pre-dose (0 hours) and at end of 30-minute infusion (Herceptin IV only) on Day 1 of Cycle 12; on Days 2, 4, 8, 15 of Cycle 12; pre-dose (0 hours) on Day 1 of Cycle 13 (cycle length of 21 days)|Secondary PKPP Population; only those participants who provided evaluable data were included.||days||Standard Deviation|Mean
860290|NCT01000506|Secondary|Mean Change From Baseline in Clinic Post-bronchodilator FEV1 Over the 52-week Treatment Period|FEV1 is defined as the volume of air forcefully expelled from the lungs in 1 second. Post-bronchodilator FEV1 measurements were taken by spirometry at Baseline, Week 16, Week 32 and Week 52. Post bronchodilator values were recorded following reversibility testing, using the maximum post bronchodilator method. Participants unable to achieve >=12% reversibility and 200 mL change at Visit 1, reversibility test was repeated at Visit 2. These procedures to achieve the maximum post-bronchodilator are generated by the Asthma Clinical Research Network. The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and the Baseline value. Analysis was performed using mixed model repeated measures with covariates of Baseline, region, Baseline maintenance OCS therapy (OCS vs. no OCS), exacerbations in the year prior to the study (as an ordinal variable), treatment and visit, plus interaction terms for visit by Baseline and visit by treatment|From Baseline up to Week 52 or EW|ITT Population. Only those participants available at the specified time points were analyzed for each treatment and represented as n=X, X, X, X respectively.||mL||Standard Error|Least Squares Mean
860291|NCT01000506|Secondary|Mean Change From Baseline in Clinic Pre-bronchodilator FEV1 Over the 52-week Treatment Period|FEV1 is defined as the volume of air forcefully expelled from the lungs in 1 second. Pre-bronchodilator FEV1 measurements were taken by spirometry at each clinic visit. The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and the Baseline value. Analysis was performed using mixed model repeated measures with covariates of Baseline, region, Baseline maintenance OCS therapy (OCS vs. no OCS), exacerbations in the year prior to the study (as an ordinal variable), treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|From Baseline up to Week 52 or EW|ITT Population. Only those participants available at the specified time points were analyzed for each treatment and represented as n=X, X, X, X respectively.||Milliliters (mL)||Standard Error|Least Squares Mean
860292|NCT01000506|Secondary|Time to First All Recorded Exacerbation|All recorded exacerbations are defined as those recorded by investigators, regardless of the outcome of the exacerbation review process. In the case, an event described as an exacerbation was not associated with a deterioration in at least one of the objectives of eDiary parameters, the investigator provided an explanation to support the decision for defining the event as an exacerbation. Kaplan-Meier estimates of the probability of an exacerbation is expressed as percentage of participants with an exacerbation over time (by week 16, week 32 and week 52).|From randomization (Week 0) to Week 52 or EW|ITT Population||Percentage of participants||95% Confidence Interval|Number
860293|NCT01000506|Secondary|Number of All Recorded Exacerbations Per Year|Clinically significant exacerbations (ex) of asthma are defined as worsening of asthma which required use of oral/systemic corticosteroids (for par. on maintenance OCS, an ex requiring OCS is defined as the use of oral/systemic corticosteroids at least double the existing maintenance dose for at least 3 days) and/or hospitalization and/or ED visit. In the case, an event described as an ex was not associated with a deterioration in >=1 of the objectives of eDiary parameters, the investigator (inv) provided an explanation to support the decision for defining the event as an ex. All recorded ex were defined as those recorded by inv, regardless of the outcome of the ex review process. Analysis was performed using Negative Binomial regression model with covariates of treatment group, BL maintenance OCS therapy (OCS vs. no OCS), region, ex in the year prior to the study (as an ordinal variable) and BL % predicted FEV1, and with logarithm of time on treatment as an offset variable.|From randomization (Week 0) to Week 52 or EW|ITT Population||Exacerbations per year|||Number
860294|NCT01000506|Secondary|Time to First Exacerbation Requiring Hospitalization or ED Visit|Exacerbations of asthma requiring hospitalization or ED visit were assessed. Kaplan-Meier estimates of the probability of an exacerbation is expressed as percentage of participants with an exacerbation over time (by Week 16, Week 32 and Week 52).|From randomization (Week 0) to Week 52 or EW|ITT Population||Percentage of participants||95% Confidence Interval|Number
860295|NCT01000506|Secondary|Number of Exacerbations Requiring Hospitalization (Including Intubation and Admittance to an Intensive Care Unit [ICU]) or ED Visit Per Year|The frequency of exacerbations of asthma requiring hospitalization (including intubation and admittance to an intensive care unit [ICU]) or ED visit over the 52-week treatment period is expressed as exacerbation rate per year. Analysis of the number of exacerbations was performed using a negative binomial regression model with covariates of treatment group, Baseline (BL) maintenance OCS therapy (OCS vs. no OCS), region, exacerbations in the year prior to the study (as an ordinal variable) and BL percent (%) predicted forced expiratory volume in 1 second (FEV1), and with logarithm of time on treatment as an offset variable.|From randomization (Week 0) to Week 52 or EW|ITT Population||Exacerbations per year|||Number
860296|NCT01000506|Secondary|Time to First Clinically Significant Exacerbation Requiring Oral or Systemic Corticosteroid, Hospitalization and/ or ED Visit|Clinically significant exacerbations of asthma are defined as worsening of asthma which required use of oral/systemic corticosteroids (for participants on maintenance OCS, an exacerbation requiring OCS is defined as the use of oral/systemic corticosteroids at least double the existing maintenance dose for at least 3 days) and/or hospitalization and/or ED visit. Kaplan-Meier estimates of the probability of an exacerbation is expressed as percentage of participants with an exacerbation over time (by Week 16, Week 32 and Week 52).|From randomization (Week 0) to Week 52 or EW|ITT Population||Percentage of participants||95% Confidence Interval|Number
860297|NCT01000506|Primary|Number of Clinically Significant Exacerbations of Asthma Per Year|Clinically significant exacerbations of asthma are defined as worsening of asthma which required use of oral/systemic corticosteroids (for participants on maintenance oral corticosteroids [OCS], an exacerbation requiring OCS is defined as the use of oral/systemic corticosteroids at least double the existing maintenance dose for at least 3 days) and/or hospitalization and/or emergency department (ED) visit. The frequency of clinically significant exacerbations of asthma over the 52-week treatment period is expressed as exacerbation rate per year. Analysis of the number of exacerbations was performed using a negative binomial regression model with covariates of treatment group, Baseline (BL) maintenance OCS therapy (OCS vs. no OCS), region, exacerbations in the year prior to the study (as an ordinal variable) and BL percent (%) predicted forced expiratory volume in 1 second (FEV1), and with logarithm of time on treatment as an offset variable|From randomization (Week 0) to Week 52 or early withdrawal (EW)|Intent-to-Treat (ITT) Population: all participants who were randomized and who received at least one dose of study medication.||Exacerbations per year|||Number
860298|NCT00981149|Secondary|Evoked Pain .|Digital palpation.|6 weeks||||||
860300|NCT00950300|Secondary|Percentage of Participants With ADAs Against Recombinant Human Hyaluronidase (rHuPH20)|Participants in the Herceptin SC arm provided samples for evaluation of anti-rHuPH20 antibodies. The cumulative percentage of participants with ADAs against rHuPH20 (an excipient unique to the SC formulation) at any time during or after treatment was reported.|Baseline; pre-dose (0 hours) on Day 1 of Cycles 2, 5, 13, 18 (cycle length of 21 days); and Months 3, 6, 12, 18, 24, 30, 36, 42, 48 from last dose of Cycle 18|Safety Population; only participants with evaluable Baseline and post-Baseline data for ADAs against rHuPH20 were included.||percentage of participants|||Number
860301|NCT00950300|Secondary|Percentage of Participants With Anti-Drug Antibodies (ADAs) Against Trastuzumab|Participants provided samples for evaluation of anti-trastuzumab antibodies. The cumulative percentage of participants with ADAs against trastuzumab at any time during or after treatment was reported.|Baseline; pre-dose (0 hours) on Day 1 of Cycles 2, 5, 13, 18 (cycle length of 21 days); and Months 3, 6, 12, 18, 24, 30, 36, 42, 48 from last dose of Cycle 18|Safety Population: All participants who received at least one dose of study medication. Only participants with evaluable Baseline and post-Baseline data for ADAs against trastuzumab were included.||percentage of participants|||Number
860302|NCT00950300|Secondary|Overall Survival (OS) as of Clinical Cutoff in January 2014|OS was estimated by Kaplan-Meier analysis and defined as the time from randomization to death from any cause. Participants who were alive at the time of analysis were censored at the day of last study drug administration, last recorded visit, or last survival follow-up information.|Continuously during treatment (up to 12 months); at Months 1, 3, 6 from last dose of Cycle 18 (cycle length of 21 days); then every 6 months until withdrawal for any reason (approximately 4 years as of January 2014 data cutoff)|ITT Population.||months||Full Range|Median
860303|NCT00950300|Secondary|Percentage of Participants Who Died as of Clinical Cutoff in January 2014|The percentage of participants who died at any time during the study was reported.|Continuously during treatment (up to 12 months); at Months 1, 3, 6 from last dose of Cycle 18 (cycle length of 21 days); then every 6 months until withdrawal for any reason (approximately 4 years as of January 2014 data cutoff)|ITT Population.||percentage of participants|||Number
860304|NCT00950300|Secondary|Event-Free Survival (EFS) as of Clinical Cutoff in January 2014|Protocol-defined events included local, regional, or distant recurrence, contralateral breast cancer, or death from any cause. After the last dose of treatment, imaging was performed at specified visits and participants were followed for survival status. EFS was estimated by Kaplan-Meier analysis and defined as the time from randomization to the first protocol-defined event. For participants without an event at the time of analysis, EFS was censored and the date of censoring was the date of last tumor assessment or last recorded visit for the participant.|Screening; Day 1 of Cycle 18 (cycle length of 21 days); and Months 6, 12, 24, 36, 48 from last dose of Cycle 18; then every 6 months until withdrawal for any reason (approximately 4 years as of January 2014 data cutoff)|ITT Population.||months||Full Range|Median
860305|NCT00950300|Secondary|Percentage of Participants Who Experienced a Protocol-Defined Event as of Clinical Cutoff in January 2014|Protocol-defined events included local, regional, or distant recurrence, contralateral breast cancer, or death from any cause. After the last dose of treatment, imaging was performed at specified visits and participants were followed for survival status. The percentage of participants who experienced a protocol-defined event at any time during the study was reported.|Screening; Day 1 of Cycle 18 (cycle length of 21 days); and Months 6, 12, 24, 36, 48 from last dose of Cycle 18; then every 6 months until withdrawal for any reason (approximately 4 years as of January 2014 data cutoff)|ITT Population.||percentage of participants|||Number
860306|NCT00950300|Secondary|Time to Response According to RECIST Version 1.0, Among Those With Measurable Disease at Baseline|Tumor response was assessed using RECIST version 1.0. CR was defined as disappearance of all target lesions and short-axis reduction of any pathological lymph nodes to <10 mm with no prior assessment of PD. PR was defined as ≥30% decrease from Baseline in sum diameter of target lesions with no prior assessment of PD. Time to response was defined as the time from first dose of study medication to the first assessment of CR or PR, which was the date the response was first documented by objective evidence, among participants with an overall response of CR or PR.|Tumor assessments at Baseline; on Day 1 Cycles 3, 5, 7 (cycle length of 21 days); and at time of surgery following eight cycles of chemotherapy (approximately 6 months overall)|EPP Population; only participants with measurable disease at Baseline and a response of CR or PR were included.||weeks||Full Range|Median
860307|NCT00950300|Secondary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0, Among Those With Measurable Disease at Baseline|Tumor response was assessed using RECIST version 1.0. CR was defined as disappearance of all target lesions and short-axis reduction of any pathological lymph nodes to less than (<) 10 millimeters (mm) with no prior assessment of progressive disease (PD). PR was defined as greater than or equal to (≥) 30% decrease from Baseline in sum diameter of target lesions with no prior assessment of PD. The percentage of participants with overall response of CR or PR at the end of neoadjuvant treatment was reported, and the 95% CI for one-sample binomial was constructed using the Pearson-Clopper method.|Tumor assessments at Baseline; on Day 1 of Cycles 3, 5, 7 (cycle length of 21 days); and at time of surgery following eight cycles of Herceptin + chemotherapy (approximately 6 months overall)|EPP Population; only participants with measurable disease at Baseline were included.||percentage of participants||95% Confidence Interval|Number
860308|NCT00950300|Secondary|Percentage of Participants With Total Pathological Complete Response (tpCR)|Participants were evaluated following eight cycles of treatment and after surgery to assess for tpCR, defined as absence of neoplastic invasive cells in the breast and axillary lymph nodes according to pathologist examination. The percentage of participants with tpCR was reported, and the 95% CI for one-sample binomial was constructed using the Pearson-Clopper method.|After surgery following eight cycles of Herceptin + chemotherapy (approximately 6 months from Baseline)|EPP Population.||percentage of participants||95% Confidence Interval|Number
860309|NCT00950300|Secondary|AUC21d of Trastuzumab After Surgery|PK samples were obtained after surgery (Cycle 12). Values were extrapolated beyond Day 15 to produce the area over the full 21-day cycle. The AUC21d value at Cycle 12 was calculated from trastuzumab concentration-time profiles using standard non-compartmental PK methods, averaged among all participants, and expressed in d*μg/mL.|Pre-dose (0 hours) and at end of 30-minute infusion (Herceptin IV only) on Day 1 of Cycle 12; on Days 2, 4, 8, 15 of Cycle 12; pre-dose (0 hours) on Day 1 of Cycle 13 (cycle length of 21 days)|Secondary PKPP Population; only those participants who provided evaluable data were included.||d*μg/mL||Standard Deviation|Mean
860311|NCT00950300|Secondary|Cmax of Trastuzumab After Surgery|PK samples were obtained after surgery (Cycle 12). The Cmax during Cycle 12 was recorded, averaged among all participants, and expressed in μg/mL.|Pre-dose (0 hours) and at end of 30-minute infusion (Herceptin IV only) on Day 1 of Cycle 12; on Days 2, 4, 8, 15 of Cycle 12; pre-dose (0 hours) on Day 1 of Cycle 13 (cycle length of 21 days)|Secondary PKPP Population; only those participants who provided evaluable data were included.||μg/mL||Standard Deviation|Mean
860312|NCT00950300|Secondary|Area Under the Concentration-Time Curve From 0 to 21 Days (AUC21d) of Trastuzumab Prior to Surgery|PK samples were obtained prior to surgery (Cycle 7). Values were extrapolated beyond Day 15 to produce the area over the full 21-day cycle. The AUC21d value at Cycle 7 was calculated from trastuzumab concentration-time profiles using standard non-compartmental PK methods, averaged among all participants, and expressed in days multiplied by micrograms per milliliters (d*μg/mL).|Pre-dose (0 hours) and at end of 30-minute infusion (Herceptin IV only) on Day 1 of Cycle 7; on Days 2, 4, 8, 15 of Cycle 7; pre-dose (0 hours) on Day 1 of Cycle 8 (cycle length of 21 days)|Primary PKPP Population; only those participants who provided evaluable data were included.||d*μg/mL||Standard Deviation|Mean
860313|NCT00950300|Secondary|Time of Maximum Serum Concentration (Tmax) of Trastuzumab Prior to Surgery|PK samples were obtained prior to surgery (Cycle 7). The Tmax during Cycle 7 was recorded, averaged among all participants, and expressed in days.|Pre-dose (0 hours) and at end of 30-minute infusion (Herceptin IV only) on Day 1 of Cycle 7; on Days 2, 4, 8, 15 of Cycle 7; pre-dose (0 hours) on Day 1 of Cycle 8 (cycle length of 21 days)|Primary PKPP Population; only those participants who provided evaluable data were included.||days||Standard Deviation|Mean
860314|NCT00950300|Secondary|Maximum Serum Concentration (Cmax) of Trastuzumab Prior to Surgery|PK samples were obtained prior to surgery (Cycle 7). The Cmax during Cycle 7 was recorded, averaged among all participants, and expressed in μg/mL.|Pre-dose (0 hours) and at end of 30-minute infusion (Herceptin IV only) on Day 1 of Cycle 7; on Days 2, 4, 8, 15 of Cycle 7; pre-dose (0 hours) on Day 1 of Cycle 8 (cycle length of 21 days)|Primary PKPP Population; only those participants who provided evaluable data were included.||μg/mL||Standard Deviation|Mean
860315|NCT00950300|Secondary|Number of Participants With Ctrough of Trastuzumab >20 μg/mL After Surgery|Pre-dose samples were obtained after surgery (Cycle 13). The number of participants who had an observed Ctrough >20 μg/mL was reported.|Pre-dose (0 hours) on Day 1 of Cycle 13 (cycle length of 21 days)|Secondary PKPP Population.||participants|||Number
860316|NCT00950300|Secondary|Number of Participants With Ctrough of Trastuzumab >20 μg/mL Prior to Surgery|Pre-dose samples were obtained prior to surgery (Cycle 8). The number of participants who had an observed Ctrough >20 μg/mL was reported.|Pre-dose (0 hours) on Day 1 of Cycle 8 (cycle length of 21 days)|Primary PKPP Population.||participants|||Number
860317|NCT00950300|Secondary|Predicted Ctrough of Trastuzumab After Surgery|Predicted Ctrough at pre-dose after surgery (Cycle 13) was determined on the basis of a population PK model from Study BP22023 (NCT00800436). The mean predicted Ctrough was expressed in μg/mL.|Pre-dose (0 hours) on Day 1 of Cycle 13 (cycle length of 21 days)|PKPP Population; only participants with a Cycle 13 pre-dose PK measurement were included in the analysis.||μg/mL||Standard Deviation|Mean
860318|NCT00950300|Secondary|Predicted Ctrough of Trastuzumab Prior to Surgery|Predicted Ctrough at pre-dose prior to surgery (Cycle 8) was determined on the basis of a population PK model from Study BP22023 (NCT00800436). The mean predicted Ctrough was expressed in μg/mL.|Pre-dose (0 hours) on Day 1 of Cycle 8 (cycle length of 21 days)|PKPP Population: All participants with at least one measurable trastuzumab serum concentration.||μg/mL||Standard Deviation|Mean
860319|NCT00950300|Secondary|Observed Ctrough of Trastuzumab After Surgery|Pre-dose samples were obtained after surgery (Cycle 13). The observed Ctrough was recorded, averaged among all participants, and expressed in μg/mL.|Pre-dose (0 hours) on Day 1 of Cycle 13 (cycle length of 21 days)|Secondary PKPP Population: All participants with at least one measurable trastuzumab serum concentration and who did not have any major protocol violations related to PK sampling for the secondary endpoint.||μg/mL||Standard Deviation|Mean
860320|NCT00950300|Primary|Percentage of Participants With Pathological Complete Response (pCR)|Participants were evaluated following eight cycles of treatment and after surgery to assess for pCR, defined as absence of neoplastic invasive cells in the breast according to pathologist examination. The percentage of participants with pCR was reported, and the 95% CI for one-sample binomial was constructed using the Pearson-Clopper method.|After surgery following eight cycles of Herceptin + chemotherapy (approximately 6 months from Baseline)|Efficacy (E) PP Population: All participants with at least one on-treatment efficacy assessment who received a full eight cycles of study treatment according to randomization and who met additional protocol-specified criteria.||percentage of participants||95% Confidence Interval|Number
860321|NCT00950300|Primary|Observed Serum Trough Concentration (Ctrough) of Trastuzumab Prior to Surgery|Pre-dose samples were obtained prior to surgery (Cycle 8). The observed Ctrough was recorded, averaged among all participants, and expressed in micrograms per milliliter (μg/mL).|Pre-dose (0 hours) on Day 1 of Cycle 8 (cycle length of 21 days)|Primary Pharmacokinetic (PK) Per Protocol (PP) Population: All participants with at least one measurable trastuzumab serum concentration and who did not have any major protocol violations related to PK sampling for the primary endpoint.||μg/mL||Standard Deviation|Mean
860322|NCT00868608|Secondary|Percentage of Participants With QTc Interval Corrected Using Fridericia’s Formula (QTcF) by Category (Safety Population)|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to the beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia’s formula (QTcF = QT divided by cube root of RR). Maximum QTcF was categorized as less than or equal to (≤) 450 msec, >450 msec to ≤480 msec, >480 msec to ≤500 msec and >500 msec. Participants are reported only once under the maximum QTcF interval observed at any of the time-points. Maximum increase from baseline was categorized as <30 msec, ≥30 to <60 msec (borderline) and ≥60 msec (prolonged) were summarized.|Screening; Cycle 1: pre-dose & 1 hour; Cycles 3 and 4: pre-dose, 1, 3, 48, and 168 hours; Cycle 6: pre-dose; end of treatment: 28 to 56 days post-last dose.|Safety Population||Percentage of Participants|||Number
860348|NCT00845182|Primary|HbA1c|change in HbA1c was measured before and after treatment in three groups|baseline and 6 months|There was a greater improvement in HbA1c from baseline after combined treatment with Pioglitazone and Exenatide when compared with either therapy alone.||percent point decrease from baseline||Standard Deviation|Mean
860323|NCT00868608|Secondary|Percentage of Participants With a Treatment Emergent Adverse Event (TEAE) (Safety Population)|Includes all TEAEs: any event that emerged after the first dose of the study treatment during the treatment period that was absent before administration of any study treatment, or worsened during the treatment period relative to the pre-treatment state.|Protocol reporting period: from informed consent to at least 28 days after the last dose.|Safety Population - includes all participants who received at least 1 dose of study medication. This population only excluded participants who never received any study medication.||Percentage of Participants|||Number
860324|NCT00868608|Secondary|Median Induced Change From Baseline of QT Study Specific Correction (QTcS) by Cycle Based on Median Maximum Calicheamicin Concentration (Cmax)|Triplicate 12-lead electrocardiogram (ECG) measurements were performed approximately 2 minutes apart. ECG assessments were pre-specified in the protocol to be time-matched with selected pharmacokinetic (PK) samples in order to conduct a concentration-QTc analysis. A study-specific QT correction factor was estimated using the un-averaged triplicate data and was used to calculate the study-specific corrected QT (QTcS). QTcS interval versus serum concentrations were modeled using a population analysis approach to identify potential effects of total calicheamicin exposure. Results for drug effects were based on the median Cmax for total calicheamicin across all participants: median Cmax was 61.3 ng/mL|Cycle 1: pre-dose, 1 hour; Cycle 3 & 4: pre-dose, 1, 3, 48, 168 hours; Cycle 6 (if applicable): pre-dose; end of treatment: during clinic visit|There were 80 participants in the analysis dataset, but time-matched PK-ECG data only existed for 73 participants (35 female).||Milliseconds (msec)||90% Confidence Interval|Median
860325|NCT00868608|Secondary|Kaplan-Meier Esitmates of the Probability of Survival at 6, 12 and 24 Months in Participants With Follicular NHL|Kaplan-Meier: a rule for calculating an estimate of survival. OS was defined as the time from enrollment to death from any cause. For participants without death, censorship occurred at the date of last contact.|6, 12 and 24 months|ITT population (participants with NHL type defined as follicular).||Probability||95% Confidence Interval|Number
860326|NCT00868608|Secondary|Kaplan-Meier Estimate of the OS in Participants With Follicular NHL|Kaplan-Meier: a rule for calculating an estimate of survival. OS was defined as the time from enrollment to death from any cause. For participants without death, censorship occurred at the date of last contact.|Any time up to 2 years after enrollment. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.|ITT population (participants with NHL type defined as follicular).||Months||95% Confidence Interval|Median
860327|NCT00868608|Secondary|Kaplan-Meier Estimates of the Probability of Survival at 6, 12 and 24 Months in Participants With Indolent NHL|Kaplan-Meier: a rule for calculating an estimate of survival. OS was defined as the time from enrollment to death from any cause. For participants without death, censorship occurred at the date of last contact.|6, 12 and 24 months|ITT population.||Probability||95% Confidence Interval|Number
860328|NCT00868608|Secondary|Kaplan-Meier Estimate of the Overall Survival (OS) in Participants With Indolent NHL|Kaplan-Meier: a rule for calculating an estimate of survival. OS was defined as the time from enrollment to death from any cause. For participants without death, censorship occurred at the date of last contact.|Any time up to 2 years after enrollment. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.|ITT population.||Months||95% Confidence Interval|Median
860329|NCT00868608|Secondary|Kaplan-Meier Estimate of the Probability of Being Alive and Free From PD or New Anticancer Therapy at 6, 12 and 24 Months in Participants With Follicular NHL|Kaplan-Meier: a rule for calculating an estimate of survival. PFS was defined as time from enrollment to progression of disease or death from any cause. Events were defined as death from any cause without progression, progression during and after treatment, and initiation of all new anti-cancer treatments for the lymphoma. For participants with no event, censorship occurred at the date of last valid disease assessment. PD was defined in accordance with the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.|6, 12 and 24 months|ITT population (participants with NHL type defined as follicular).||Percenr probability||95% Confidence Interval|Number
860330|NCT00868608|Secondary|Kaplan-Meier Estimate of the PFS in Participants With Follicular NHL|Kaplan-Meier: a rule for calculating an estimate of survival. PFS was defined as time from enrollment to progression of disease or death from any cause. Events were defined as death from any cause without progression, progression during and after treatment, and initiation of all new anti-cancer treatments for the lymphoma. For participants with no event, censorship occurred at the date of last valid disease assessment. PD was defined in accordance with the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.|Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.|ITT population (participants with NHL type defined as follicular).||Months||95% Confidence Interval|Median
860331|NCT00868608|Secondary|Kaplan-Meier Estimates of the Probability of Being Alive and Free From PD or New Anticancer Therapy at 6, 12 and 24 Months in Participants With Indolent NHL|Kaplan-Meier: a rule for calculating an estimate of survival. PFS was defined as time from enrollment to death from any cause without progression, progression during and after treatment, and initiation of all new anti-cancer treatments for the lymphoma. For participants with no event, censorship occurred at the date of last valid disease assessment. PD was defined in accordance with the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.|6, 12 and 24 months|ITT population.||Percent Probability||95% Confidence Interval|Number
860332|NCT00868608|Secondary|Kaplan-Meier Estimate of the Progression-Free Survival (PFS) in Participants With Indolent NHL|Kaplan-Meier: a rule for calculating an estimate of survival. PFS was defined as time from enrollment to death from any cause without progression, progression during and after treatment, and initiation of all new anti-cancer treatments for the lymphoma. For participants with no event, censorship occurred at the date of last valid disease assessment. PD was defined in accordance with the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.|Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.|ITT population.||Months||95% Confidence Interval|Median
860333|NCT00868608|Secondary|Probability of Maintaining a Response at 6, 12 and 24 Months in Participants With Follicular NHL|Duration of response was measured from the first date of response until the first date that the objective PD or symptomatic deterioration or initiation of new anticancer therapy for the lymphoma or death from any cause is documented. Participants without an event were censored at the date of the last valid tumor assessment. A valid tumor assessment visit was defined as the tumor assessment visit with overall response of CR, PR, stable disease (SD), or PD, but not ‘Not Done’ or ‘Unknown’. PD was defined according to the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.|6, 12 and 24 months|Participants with Follicular NHL who responded.||Probability||95% Confidence Interval|Number
860334|NCT00868608|Secondary|Duration of Response in Participants With Follicular NHL|Duration of response was measured from the first date of response until the first date that the objective PD or symptomatic deterioration or initiation of new anticancer therapy for the lymphoma or death from any cause is documented. Participants without an event were censored at the date of the last valid tumor assessment. A valid tumor assessment visit was defined as the tumor assessment visit with overall response of CR, PR, stable disease (SD), or PD, but not ‘Not Done’ or ‘Unknown’. PD was defined according to the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.|Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.|Participants with Follicular NHL who responded.||Months||95% Confidence Interval|Median
860335|NCT00868608|Secondary|Probability of Maintaining a Response at 6, 12 and 24 Months in Participants With Indolent NHL|Duration of response was measured from the first date of response until the first date that the objective PD or symptomatic deterioration or initiation of new anticancer therapy for the lymphoma or death from any cause is documented. Participants without an event were censored at the date of the last valid tumor assessment. A valid tumor assessment visit was defined as the tumor assessment visit with overall response of CR, PR, stable disease (SD), or PD, but not ‘Not Done’ or ‘Unknown’. PD was defined according to the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.|6, 12 and 24 months|Participants with Indolent NHL who responded.||Probability||95% Confidence Interval|Number
860336|NCT00868608|Secondary|Duration of Response in Participants With Indolent NHL|Duration of response was measured from the first date of response until the first date that the objective progression of disease (PD) or symptomatic deterioration or initiation of new anticancer therapy for the lymphoma or death from any cause is documented. Participants without an event were censored at the date of the last valid tumor assessment. A valid tumor assessment visit was defined as the tumor assessment visit with overall response of CR, PR, stable disease (SD), or PD, but not ‘Not Done’ or ‘Unknown’. PD was defined according to the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.|Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.|Participants with Indolent NHL who responded.||Months||95% Confidence Interval|Median
860337|NCT00868608|Secondary|Percentage of Participants With Follicular NHL Achieving a CR According to International Response Criteria for NHL|CR was defined as complete disappearance of all target lesions and disease-related symptoms; all nodes must have decreased to normal (≤1.5 cm in their greatest transverse diameter for nodes >1.5 cm before therapy) or ≤1 cm (short axis) in previously involved node; enlarged spleen prior to therapy must have regressed and be non-palpable; bone marrow lymphoma: infiltrate must have been cleared on repeat bone marrow aspirate and biopsy.|Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.|ITT population (participants with NHL type defined as follicular).||Percentage of Participants||95% Confidence Interval|Number
860349|NCT00845182|Primary|Effect of Pioglitazone, Exenatide and Combined Pioglitazone and Exenatide on Body Weight|Effect of Pioglitazone, Exenatide and combined Pioglitazone and Exenatide on body weight and beta cell function|baseline and 6 months|we analyzed the weight at the end of study completion||kg||Standard Deviation|Mean
860338|NCT00868608|Secondary|Percentage of Participants With Indolent NHL Achieving a CR According to International Response Criteria for NHL|CR was defined as complete disappearance of all target lesions and disease-related symptoms; all nodes must have decreased to normal (≤1.5 cm in their greatest transverse diameter for nodes >1.5 cm before therapy) or ≤1 cm (short axis) in previously involved node; enlarged spleen prior to therapy must have regressed and be non-palpable; bone marrow lymphoma: infiltrate must have been cleared on repeat bone marrow aspirate and biopsy.|Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.|ITT population.||Percentage of Participants||95% Confidence Interval|Number
860339|NCT00868608|Secondary|Percentage of Participants With Follicular NHL Achieving CR or PR According to International Response Criteria for NHL|CR was defined as complete disappearance of all target lesions and disease-related symptoms; all nodes must have decreased to normal (≤1.5 cm in their greatest transverse diameter for nodes >1.5 cm before therapy) or ≤1 cm (short axis) in previously involved node; enlarged spleen prior to therapy must have regressed and be non-palpable; bone marrow lymphoma: infiltrate must have been cleared on repeat bone marrow aspirate and biopsy. PR was defined as >50% decrease in the SPD of up to 6 index lesions. No increase in size of other nodes, liver or spleen. Splenic and hepatic nodules must have regressed by ≥50% in the SPD or greatest transverse diameter (for single nodules). With exception of splenic and hepatic nodules, involvement of other organs was usually assessable and no measurable disease should be present. No progression of non-target disease or new lesions.|Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.|ITT population (participants with NHL type defined as follicular).||Percentage of Participants||95% Confidence Interval|Number
860340|NCT00868608|Primary|Percentage of Participants With Indolent NHL Achieving CR or Partial Response (PR) According to International Response Criteria for NHL|CR was defined as complete disappearance of all target lesions and disease-related symptoms; all nodes must have decreased to normal (less than or equal to [≤]1.5 cm in their greatest transverse diameter [GTD] for nodes more than [>]1.5 cm before therapy) or ≤1 cm (short axis) in previously involved node; enlarged spleen prior to therapy must have regressed and be non-palpable; bone marrow lymphoma: infiltrate must have been cleared on repeat bone marrow aspirate and biopsy. PR was defined as >50% decrease in the sum of the product diameters (SPD) of up to 6 index lesions. No increase in size of other nodes, liver or spleen. Splenic and hepatic nodules must have regressed by greater than or equal to [≥]50% in the SPD or GTD (for single nodules). With exception of splenic and hepatic nodules, involvement of other organs was usually assessable and no measurable disease should be present. No progression of non-target disease or new lesions.|Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.|Intent to treat (ITT) population: all participants who were enrolled into the study.||Percentage of Participants||95% Confidence Interval|Number
860341|NCT00860743|Primary|Heart Rate Variability (Aim 2)|Heart rate variability (HRV) was measured before and after exposure to intermittent hypoxia following administration of a placebo or antioxidant cocktail. Heart rate variability refers to beat-to-beat alterations in heart rate. Under resting conditions, the electrocardiogram of healthy individuals reveals periodic variation in R-R intervals. To measure HRV, R-R interval data are presented in a graph, in which the y-axis plots the R-R intervals (ms2), and the x-axis the total number of beats. Spectral analysis of the graph transforms the signal from time to frequency on the x-axis (Hz), by representing the signal as a combination of sine and cosine waves, with different amplitudes and frequencies. The approach uses Fourier transforms. The heart rate spectrum contains a high frequency (0.15-0.4 Hz) component, which is synchronous with respiration and a low frequency (0.04 to 0.15 Hz) component that appears to be mediated by both the vagus and cardiac sympathetic nerves.|Within the same experimental session|Measurements were made before and after intermittent hypoxia following administration of a placebo or antioxidant cocktail. Please note that analysis of the heart rate variability measures for the healthy group have not been completed to date.||ms2/Hz||Standard Error|Mean
860342|NCT00860743|Primary|Ventilation (Aim 1)|Ventilation was measured before and after exposure to intermittent hypoxia in males and females. Ventilation was measured using a pneumotachograph, which is a flow measuring device.|Within the same experimental session|||fraction of baseline||Standard Error|Mean
860343|NCT00858494|Secondary|Parental Report of an Adverse Event After a Dose of Study Medication|After each dose of study medication parents reported the presence of any adverse events|data collected after doses occurring up to 10 days after index visit|Study logs were returned in 37 of 49 enrolled participants. After each dose of study medication, the participant's parent indicated in the study log whether any adverse events were noted.||doses|doses||Number
860344|NCT00858494|Primary|Relief of Upper Respiratory Tract Infection (URI) Symptoms (Cough, Runny Nose, Nasal Congestion, Sneezing)1 Hour After Dose of Homeopathic Remedy.|For each dose of study medication, parents indicated which of the symptoms were present (runny nose, cough, nasal congestion, sneezing). Parents rated change in each symptom present one hour after a dose of study medication for up to 6 doses in study logs. Responses were dichotomized as at least some improvement or better (improvement) vs. no improvement or worse. The outcome measure is number of times that improvement in a specific symptom was noted after a dose of the homeopathic remedy. Completed study logs were received from 37 of 49 enrolled participants.|up to 10 days from index visit|Some symptoms were not present at each dose of the homeopathic remedy. Number of doses at which symptom was present: runny nose: 135, nasal congestion: 152, cough: 154, sneezing 81. The outcome is number of times improvement in each symptom was noted.||doses|doses||Number
860345|NCT00858494|Secondary|Side Effects Related to the Study Medication||10 days||||||
860346|NCT00858494|Primary|Severity of Cold Symptoms||one hour after receiving dose||||||
860347|NCT00845182|Secondary|Effect Pioglitazone, Exenatide, and Pioglitazone Plus Exenatide on • Insulin Sensitivity • Inflammatory Cytokines • Glucagon and Free Fatty Acids • Plasma Lipids|"Effect pioglitazone, exenatide, and pioglitazone plus exenatide on
Insulin sensitivity
Inflammatory cytokines
glucagon and free fatty acids
plasma lipids measured over a 6 month period"|6 months||11/2017||||
860350|NCT00781937|Secondary|Binge Eating Scale Scores by Week and Severity|Binge Eating Scale (BES) scores are based on responses to the Binge Eating Scale Questionnaire, a 16-item self-reporting diagnostic tool scaled 0-46 (Non-binging: 0-17; Moderate: 17-26; Severe: 27-46)|Week 0, week 50 and week 57|Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)||scores on a scale||Standard Deviation|Mean
860351|NCT00781937|Secondary|Number of Subjects Using Concomitant Medications (Antihypertensive Medications, Lipid Lowering Medications, or Antipsychotic Medications)|Number of subjects using concomitant medications at Week 0 and Week 56, respectively|Week 0 and week 56|Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)||Subjects|||Number
860352|NCT00781937|Secondary|Change From Baseline in Glycaemic Control Parameter: HbA1c (Glycosylated Haemoglobin)|Change in HbA1c percent values from Week 0 (X%) to Week 56 (Y%) was calculated [X% - Y%].|Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)||percentage point||Standard Error|Least Squares Mean
860353|NCT00781937|Secondary|Change From Baseline in Glycaemic Control Parameter: Fasting Serum Insulin|Subjects were tested having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)||pmol/L||Standard Error|Least Squares Mean
860354|NCT00781937|Secondary|Change From Baseline in Glycaemic Control Parameter: Fasting Plasma Glucose (FPG)|Subjects were tested having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)||mmol/L||Standard Error|Least Squares Mean
860355|NCT00781937|Secondary|Change From Baseline in Glycaemic Control Parameter: HOMA-IR (Homeostasis Model Assessment - Insulin Resistance)|Change in insulin resistance values from Week 0 (X) to Week 56 (Y) was calculated [X - Y]. Insulin resistance was derived from fasting serum insulin levels in blood samples using the HOMA method, which is based on the assumption that normal-weight subjects without diabetes aged <35 years have median insulin resistance indexed at 1.00.|Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)||proportion||Standard Error|Least Squares Mean
860356|NCT00781937|Secondary|Change From Baseline in Glycaemic Control Parameter: HOMA-B (Homeostasis Model Assessment - Beta Cell Function)|Change in beta-cell function percent values from Week 0 (X%) to Week 56 (Y%) was calculated [X% - Y%]. Beta-cell function was derived from fasting plasma glucose readings in blood samples using the HOMA method, which is based on the assumption that normal-weight subjects without diabetes aged <35 years have median beta-cell function indexed at 100%.|Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)||percent change||Standard Error|Least Squares Mean
860357|NCT00781937|Secondary|Change From Baseline in Body Mass Index (BMI)||Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)||kg/m^2||Standard Error|Least Squares Mean
860358|NCT00781937|Secondary|Change From Baseline in Waist Circumference||Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)||cm||Standard Error|Least Squares Mean
860359|NCT00781937|Secondary|Percentage of Subjects Meeting Metabolic Syndrome Criteria: ATP (Adult Treatment Panel) III at Week 56|Metabolic syndrome status required at least 3 of 5 criteria met: Waist circumference (men ≥102cm, women ≥88cm); Triglycerides >1.7mmol/L; High density lipoprotein cholesterol (men <0.9mmol/L, women <1.1mmol/L) or on drug therapy; Blood pressure ≥130mmHg systolic or ≥85mmHg diastolic or on drug therapy; Fasting glucose ≥5.5mmol/L or on drug therapy.|Week 56|Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)||percentage of subjects|||Number
860360|NCT00781937|Secondary|Change From Baseline in Cardiovascular Biomarker: High Sensitivity C-reactive Protein (hsCRP)||Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)||nmol/L||Standard Error|Least Squares Mean
860361|NCT00781937|Secondary|Change From Baseline in Fasting Lipid Profile: Total Cholesterol|Subjects were tested having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)||mmol/L||Standard Error|Least Squares Mean
860362|NCT00781937|Secondary|Change From Baseline in Fasting Lipid Profile: Low Density Lipoprotein (LDL) Cholesterol|Subjects were tested having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)||mmol/L||Standard Error|Least Squares Mean
860363|NCT00781937|Secondary|Change From Baseline in Fasting Lipid Profile: Triglycerides|Subjects were tested having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)||mmol/L||Standard Error|Least Squares Mean
860364|NCT00781937|Secondary|Change From Baseline in Pulse||Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)||beats/minute||Standard Error|Least Squares Mean
860366|NCT00781937|Secondary|Change From Baseline in Fasting Weight for Subjects Completing the Main Trial Period and Entering the Follow-up Period|Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 68|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)||kg||Standard Error|Least Squares Mean
860367|NCT00781937|Secondary|Change From Baseline in Fasting Weight|Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)||kg||Standard Error|Least Squares Mean
860368|NCT00781937|Secondary|Percentage of Subjects With Greater Than 75% of Fasting run-in Weight Loss Maintained From Week 0|Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 56|Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)||percentage of subjects|||Number
860369|NCT00781937|Secondary|Percentage of Subjects With Greater Than 50% of Fasting run-in Weight Loss Maintained From Week 0|Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 56|Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)||percentage of subjects|||Number
860370|NCT00781937|Secondary|Percentage of Subjects With Weight Regain (Fasting) More Than or Equal to 10% From Week 0|Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 56|Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)||percentage of subjects|||Number
860371|NCT00781937|Secondary|Percentage of Subjects With Weight Regain (Fasting) More Than or Equal to 5% From Week 0|Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 56|Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)||percentage of subjects|||Number
860372|NCT00781937|Secondary|Percentage of Subjects Who Lost More Than 10% of Fasting Body Weight From Week 0|Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 56|Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)||percentage of subjects|||Number
860373|NCT00781937|Primary|Percentage of Subjects Who Lost More Than or Equal to 5% of Fasting Body Weight From Week 0|Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)||percentage of subjects|||Number
860374|NCT00781937|Primary|Percentage of Subjects Who Maintained Their run-in Fasting Weight Loss From Week 0|Subjects who had a weight regain less than or equal to 0.5% of weight from Week 0 were regarded as maintenance of run-in fasting weight loss. Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)||percentage of subjects|||Number
860375|NCT00781937|Primary|Mean Percentage Change in Fasting Body Weight From Baseline|Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)||percentage||Standard Error|Least Squares Mean
860376|NCT00721409|Secondary|Number of Participants With Treatment-Related Adverse Events at Phase 2|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Maximum treatment duration (approximately 41 months)|As treated set included all treated participants classified by the treatment actually received.||Participants|||Number
860377|NCT00721409|Secondary|Number of Participants With TEAEs (All Causalities) at Phase 2|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment emergent adverse events were those with initial onset or that worsen in severity after the first dose of study medication.|Maximum treatment duration (approximately 41 months)|As treated set included all treated participants classified by the treatment actually received.||Participants|||Number
860378|NCT00721409|Secondary|Percentage of Participants With Tumor Expression of CYP19A1 and CCND1 Genotypes at Phase 2|One 2-mL blood specimen was collected for the analysis of germline polymorphism in CYP19A1 and CCND1 genes. A single nucleotide polymorphism (SNP) rs4646 as defined in the National Center for Biotechnology Information (NCBI) database in the aromatase gene (CYP19A1) was analyzed. A germline polymorphism G/A870 (rs9344) in the CCND1 gene was analyzed.|Screening visit (≤ 28 Days prior to dosing)|Polymorphism analysis set included participants in the safety analysis set who had at least 1 polymorphism assessment.||Percentage of participants|||Number
860379|NCT00721409|Secondary|Summary of Copy Number for CCND1 (CCND1/CEP11) and p16/INK4A (p16/CEP9) at Phase 2|Gene copy number for CCND1 (CCND1/CEP11) and p16/INK4A (p16/CEP9) were evaluated. This analysis was done for Phase 2 combined group.|Screening visit (≤ 28 Days prior to dosing)|Copy number analysis set included participants in the Safety Analysis Set who had at least 1 of the biomarker assessments.||Copy number||Standard Deviation|Mean
860380|NCT00721409|Secondary|Presence or Absence of Tumor Tissue Biomarkers at Phase 2 - Tumor Retinoblastoma (RB) and CyclinD1|Presence or absence of tumor RB and CyclinD1 were evaluated. The following definitions of expression applied in the below table: Positive: any expression >0 and Negative: any expression=0.|Screening visit (≤ 28 Days prior to dosing)|Protein biomarkers analysis set included all participants in the safety analysis set who had at least protein biomarker assessment.||Participants|||Number
860381|NCT00721409|Secondary|Presence or Absence of Tumor Tissue Biomarkers at Phase 2 - Ki67|Frequency of tumor tissue biomarker Ki67 was evaluated in across treatment groups.|Screening visit (≤ 28 Days prior to dosing)|All participants in the Safety Analysis set who had a Ki67 protein biomarker assessment.||Participants|||Number
860382|NCT00721409|Secondary|Presence or Absence of Tumor Tissue Biomarkers at Phase 2 - p16/INK4A, CCND1|Tissue samples were used for retrospective biomarker analyses. For Phase 2 Part 2, the tissue samples were sent to a central laboratory for the assessment of participant selection biomarkers. For Phase 2 Part 1, the assessment of the biomarkers (CCND1 amplification and/or loss of p16) were performed retrospectively from the available samples.|Screening visit (≤ 28 Days prior to dosing)|Copy number analysis set included participants in the Safety Analysis Set who had at least 1 of the biomarker assessments.||Participants|||Number
860383|NCT00721409|Secondary|Change From Baseline in Modified Brief Pain Inventory in Pain Interference Scale (mBPI-sf) Questionnaire at Phase 2|The mBPI-sf is a validated and reliable self-report questionnaire which consists of 13 questions that assess the severity and impact of pain on daily function. The 13 items of the questionnaire make up two scales and two single items. The scales include the 4-item Pain Severity Scale (worst pain, least pain, average pain, and pain right now) and the 7-item Pain Interference Scale (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). Each item of the pain severity and pain interference scales are based on a 11-point numeric rating scale from 0 (“no pain” or “does not interfere”) to 10 (“pain as bad as you can imagine” or “completely interferes”).|Baseline, End of treatment (approximately 41 months)|Patient reported outcome evaluable participants included participants who had received at least 1 dose of study medication, had baseline data, and at least one post-baseline measurement.||Units on a scale||Standard Error|Mean
860384|NCT00721409|Secondary|Change From Baseline in Modified Brief Pain Inventory in Pain Severity Scale (mBPI-sf) Questionnaire at Phase 2|The mBPI-sf is a validated and reliable self-report questionnaire which consists of 13 questions that assess the severity and impact of pain on daily function. The 13 items of the questionnaire make up two scales and two single items. The scales include the 4-item Pain Severity Scale (worst pain, least pain, average pain, and pain right now) and the 7-item Pain Interference Scale (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). Each item of the pain severity and pain interference scales are based on a 11-point numeric rating scale from 0 (“no pain” or “does not interfere”) to 10 (“pain as bad as you can imagine” or “completely interferes”).|Baseline, End of treatment (approximately 41 months)|Patient reported outcome evaluable participants included participants who had received at least 1 dose of study medication, had baseline data, and at least one post-baseline measurement.||Units on a scale||Standard Error|Mean
860385|NCT00721409|Secondary|Time to Tumor Progression (TTP) at Phase 2-Investigator Assessment|Time in weeks, (months or years) from randomization or (start of study treatment for non-randomized studies) to first documentation of objective tumor progression. TTP was calculated as (first event date or last known progression-free date minus the date of randomization [or first dose of study medication for non-randomized studies] plus 1) divided by 7 or 30.44 if in months. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD] per RECIST).|From randomization up to the end of treatment (approximately 41 months)|ITT was used. This represented all randomized participants from Ph2P1or Ph2P2 or Ph2P1+Ph2P2, where participants were classified according to the randomized treatment regardless of what treatment, if any, was received.||Months||95% Confidence Interval|Median
860386|NCT00721409|Secondary|Number of Participants With CBR at Phase 2 - Investigator Assessment|CBR is defined as a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) for at least 24 weeks on study according to RECIST.|From randomization up to the end of treatment (approximately 41 months)|ITT was used. This represented all randomized patients from Ph2P1or Ph2P2 or Ph2P1+Ph2P2, where participants were classified according to the randomized treatment regardless of what treatment, if any, was received.||Percentage of participants||95% Confidence Interval|Number
860387|NCT00721409|Secondary|Duration of Response at Phase 2 - Investigator Assessment|Time in weeks, (months or years) from randomization or (start of study treatment for non-randomized studies) to first documentation of objective tumor progression. TTP was calculated as (first event date or last known progression-free date minus the date of randomization [or first dose of study medication for non-randomized studies] plus 1) divided by 7 or 30.44 if in months. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD] per RECIST).|From randomization up to the end of treatment (approximately 41 months)|A subset of ITT population i.e., participants who had response was used for this analysis.||Months||95% Confidence Interval|Median
860388|NCT00721409|Secondary|Objective Response Rate - Percentage of Participants With Confirmed Objective Response in Participants With Measurable Disease at Phase 2- Investigator Assessment|Percentage of participants with objective response based assessment of confirmed CR or PR according to RECIST. Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. Per RECIST v1.0: CR defined as disappearance of all target lesions and non-target lesions. PR defined as ≥30% decrease in sum of the LD of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non target lesions. Measurable disease referred to the lesions that was accurately measured in at least 1 dimension (longest diameter to be recorded) as ≥20 mm with conventional techniques or as ≥10-16 mm with spiral computer tomography scan (depending on reconstruction interval). Clinical lesions were only be considered measurable when they were superficial (eg, skin nodules, palpable lymph nodes).|From randomization up to the end of treatment (approximately 41 months)|Participants in ITT population with measurable disease were used.||Percentage of participants||95% Confidence Interval|Number
860389|NCT00721409|Secondary|Objective Response Rate - Percentage of Participants With Confirmed Objective Response at Phase 2- Investigator Assessment|Percentage of participants with objective response based assessment of confirmed CR or confirmed PR according to RECIST. Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. Per RECIST v1.0: CR defined as disappearance of all target lesions and non-target lesions. PR defined as ≥30% decrease in sum of the longest diameters (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non target lesions.|From randomization up to the end of treatment (approximately 41 months)|ITT was used. This represented all randomized participants from Ph2P1or Ph2P2 or Ph2P1+Ph2P2, where participants were classified according to the randomized treatment regardless of what treatment, if any, was received.||Percentage of participants||95% Confidence Interval|Number
860390|NCT00721409|Secondary|Overall Survival (OS) at Phase 2|Time in weeks or months from randomization to date of death due to any cause. OS was calculated as (the death date or last known alive date (if death date unavailable) minus the date of randomization plus 1) divided by 7 or 30.44 if in months.|From randomization until death (assessed up to 41 months)|ITT was used. This represented all randomized participants from Ph2P1or Ph2P2 or Ph2P1+Ph2P2, where participants were classified according to the randomized treatment regardless of what treatment, if any, was received.||Months||95% Confidence Interval|Median
860391|NCT00721409|Secondary|Number of Participants With Increase From Baseline in Corrected QT (QTc) Interval at Phase 1|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia’s formula (QTcF = QT divided by cube root of RR), by Bazette’s formula (QTcB = QT divided by square root of RR) and corrected QT interval according to study-specific criteria (QTcS). Participants with maximum increase from baseline of 30 to less than (<) 60 msec(borderline) and greater than or equal to (>=) 60 msec (prolonged) were summarized.|Cycle 1 Day 1 prior to dosing, Cycle 1 Day 14 (2, 4 [prior to meal], 8, 24, 48, and 96 hours after dosing of Palbociclib), Cycle 2 Day 1 and Day 14 (prior to and 4 hours after dosing of letrozole)|Safety analysis set included all participants who received at least 1 dose of any agent of the combination.||Participants|||Number
860392|NCT00721409|Secondary|Summary of Plasma Letrozole Pharmacokinetic Parameter Following Letrozole Alone and in Combination With Palbociclib: Tmax at Phase 1|On Cycle 2 Day 14, plasma pharmacokinetic samples for Palbociclib and letrozole were collected prior to and 1, 2, 4, 8, 12 and 24 hours after Palbociclib and letrozole dosing. On Cycle 2 Day 28, plasma pharmacokinetic samples were collected prior to and 1, 2, 4, 8, 12, and 24 hours after letrozole dosing.|Cycle 2 Day 14, and Cycle 2 Day 28|The pharmacokinetic concentration set included all participants who were treated and had at least 1 concentration measurement in at least 1 pharmacokinetic assessment day. The pharmacokinetic parameter analysis set consisted of all participants treated who had at least 1 of the pharmacokinetic parameters of primary interest.||Hour||Full Range|Median
860393|NCT00721409|Secondary|Summary of Plasma Letrozole Pharmacokinetic Parameter Following Letrozole Alone and in Combination With Palbociclib: Cmax at Phase 1|On Cycle 2 Day 14, plasma pharmacokinetic samples for Palbociclib and letrozole were collected prior to and 1, 2, 4, 8, 12 and 24 hours after Palbociclib and letrozole dosing. On Cycle 2 Day 28, plasma pharmacokinetic samples were collected prior to and 1, 2, 4, 8, 12, and 24 hours after letrozole dosing.|Cycle 2 Day 14, and Cycle 2 Day 28|The pharmacokinetic concentration set included all participants who were treated and had at least 1 concentration measurement in at least 1 pharmacokinetic assessment day. The pharmacokinetic parameter analysis set consisted of all participants treated who had at least 1 of the pharmacokinetic parameters of primary interest.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
860394|NCT00721409|Secondary|Summary of Plasma Letrozole Pharmacokinetic Parameter Following Letrozole Alone and in Combination With Palbociclib: AUC24 at Phase 1|On Cycle 2 Day 14, plasma pharmacokinetic samples for Palbociclib and letrozole were collected prior to and 1, 2, 4, 8, 12 and 24 hours after Palbociclib and letrozole dosing. On Cycle 2 Day 28, plasma pharmacokinetic samples were collected prior to and 1, 2, 4, 8, 12, and 24 hours after letrozole dosing.|Cycle 2 Day 14, Cycle 2 Day 28|The pharmacokinetic concentration set included all participants who were treated and had at least 1 concentration measurement in at least 1 pharmacokinetic assessment day. The pharmacokinetic parameter analysis set consisted of all participants treated who had at least 1 of the pharmacokinetic parameters of primary interest.||ng·hr/mL||Geometric Coefficient of Variation|Geometric Mean
860395|NCT00721409|Secondary|Summary of Plasma Palbociclib Steady-state Pharmacokinetic Parameter Following Palbociclib Alone and in Combination With Letrozole: Apparent Volume of Distribution (Vz/F) at Phase 1|On Cycle 1 Day 14, plasma pharmacokinetic samples were collected prior to and 1, 2, 4, 8, 12, 24, 48, 96 and 120 hours after Palbociclib dosing. On Cycle 2 Day 14, plasma pharmacokinetic samples for Palbociclib and letrozole were collected prior to and 1, 2, 4, 8, 12 and 24 hours after Palbociclib and letrozole dosing.|Cycle 1 Day 14, and Cycle 2 Day 14|The pharmacokinetic concentration set included all participants who were treated and had at least 1 concentration measurement in at least 1 pharmacokinetic assessment day. The pharmacokinetic parameter analysis set consisted of all participants treated who had at least 1 of the pharmacokinetic parameters of primary interest.||L||Geometric Coefficient of Variation|Geometric Mean
860396|NCT00721409|Secondary|Summary of Plasma Palbociclib Steady-state Pharmacokinetic Parameter Following Palbociclib Alone and in Combination With Letrozole: Apparent Clearance (CL/F) at Phase 1|On Cycle 1 Day 14, plasma pharmacokinetic samples were collected prior to and 1, 2, 4, 8, 12, 24, 48, 96 and 120 hours after Palbociclib dosing. On Cycle 2 Day 14, plasma pharmacokinetic samples for Palbociclib and letrozole were collected prior to and 1, 2, 4, 8, 12 and 24 hours after Palbociclib and letrozole dosing.|Cycle 1 Day 14, and Cycle 2 Day 14|The pharmacokinetic concentration set included all participants who were treated and had at least 1 concentration measurement in at least 1 pharmacokinetic assessment day. The pharmacokinetic parameter analysis set consisted of all participants treated who had at least 1 of the pharmacokinetic parameters of primary interest.||L/hr||Geometric Coefficient of Variation|Geometric Mean
860466|NCT00422058|Secondary|Change From Baseline in Blood Pressure at Week 104|Calculated as mean blood pressure at week 104-baseline.|Week 0, week 104|ITT (intention to treat) analysis set using (LOCF) last observation carried forward is all randomised and exposed subjects from the double-blind period, who have been exposed to at least one dose of trial product||mmHg||Standard Deviation|Mean
860397|NCT00721409|Secondary|Summary of Plasma Palbociclib Steady-state Pharmacokinetic Parameter Following Palbociclib Alone and in Combination With Letrozole: Terminal Plasma Half-life (t1/2) at Phase 1|On Cycle 1 Day 14, plasma pharmacokinetic samples were collected prior to and 1, 2, 4, 8, 12, 24, 48, 96 and 120 hours after Palbociclib dosing. On Cycle 2 Day 14, plasma pharmacokinetic samples for Palbociclib and letrozole were collected prior to and 1, 2, 4, 8, 12 and 24 hours after Palbociclib and letrozole dosing.|Cycle 1 Day 14, and Cycle 2 Day 14|The pharmacokinetic concentration set included all participants who were treated and had at least 1 concentration measurement in at least 1 pharmacokinetic assessment day. The pharmacokinetic parameter analysis set consisted of all participants treated who had at least 1 of the pharmacokinetic parameters of primary interest.||Hour||Standard Deviation|Mean
860398|NCT00721409|Secondary|Summary of Plasma Palbociclib Steady-state Pharmacokinetic Parameter Following Palbociclib Alone and in Combination With Letrozole: Time to Maximum Plasma Concentration (Tmax) at Phase 1|On Cycle 1 Day 14, plasma pharmacokinetic samples were collected prior to and 1, 2, 4, 8, 12, 24, 48, 96 and 120 hours after Palbociclib dosing. On Cycle 2 Day 14, plasma pharmacokinetic samples for Palbociclib and letrozole were collected prior to and 1, 2, 4, 8, 12 and 24 hours after Palbociclib and letrozole dosing.|Cycle 1 Day 14, and Cycle 2 Day 14|The pharmacokinetic concentration set included all participants who were treated and had at least 1 concentration measurement in at least 1 pharmacokinetic assessment day. The pharmacokinetic parameter analysis set consisted of all participants treated who had at least 1 of the pharmacokinetic parameters of primary interest.||Hour||Full Range|Median
860399|NCT00721409|Secondary|Summary of Plasma Palbociclib Steady-state Pharmacokinetic Parameter Following Palbociclib Alone and in Combination With Letrozole: Maximum Observed Plasma Concentration (Cmax) at Phase 1|On Cycle 1 Day 14, plasma pharmacokinetic samples were collected prior to and 1, 2, 4, 8, 12, 24, 48, 96 and 120 hours after Palbociclib dosing. On Cycle 2 Day 14, plasma pharmacokinetic samples for Palbociclib and letrozole were collected prior to and 1, 2, 4, 8, 12 and 24 hours after Palbociclib and letrozole dosing.|Cycle 1 Day 14, and Cycle 2 Day 14|The pharmacokinetic concentration set included all participants who were treated and had at least 1 concentration measurement in at least 1 pharmacokinetic assessment day. The pharmacokinetic parameter analysis set consisted of all participants treated who had at least 1 of the pharmacokinetic parameters of primary interest.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
860400|NCT00721409|Secondary|Summary of Plasma Palbociclib Steady-state Pharmacokinetic Parameter Following Palbociclib Alone and in Combination With Letrozole: Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours (AUC24) at Phase 1|On Cycle 1 Day 14, plasma pharmacokinetic samples were collected prior to and 1, 2, 4, 8, 12, 24, 48, 96 and 120 hours after Palbociclib dosing. On Cycle 2 Day 14, plasma pharmacokinetic samples for Palbociclib and letrozole were collected prior to and 1, 2, 4, 8, 12 and 24 hours after Palbociclib and letrozole dosing.|Cycle 1 Day 14, and Cycle 2 Day 14|The pharmacokinetic concentration set included all participants who were treated and had at least 1 concentration measurement in at least 1 pharmacokinetic assessment day. The pharmacokinetic parameter analysis set consisted of all participants treated who had at least 1 of the pharmacokinetic parameters of primary interest.||ng·hr/mL||Geometric Coefficient of Variation|Geometric Mean
860401|NCT00721409|Secondary|Percentage of Participants With Clinical Benefit Response (CBR) at Phase 1|CBR is defined as a confirmed CR, confirmed PR, or stable disease (SD) for at least 24 weeks on study according to RECIST. Confirmed responses are those that persisted on repeat imaging >= 4 weeks after initial response.|From Baseline up to end of study (assessed up to 55 months)|Efficacy analysis set included all enrolled participants with the disease under study, adequate baseline disease assessment, and who started study treatment.||Percentage of participants||95% Confidence Interval|Number
860402|NCT00721409|Secondary|Objective Response Rate - Percentage of Participants With Confirmed Objective Tumor Response at Phase 1|Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. Per RECIST v1.0: CR defined as disappearance of all target lesions and non-target lesions. PR defined as ≥30% decrease in sum of the longest diameters (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non target lesions.|From Baseline up to end of study (assessed up to 55 months)|Efficacy analysis set included all enrolled participants with the disease under study, adequate baseline disease assessment, and who started study treatment.||Percentage of participants||95% Confidence Interval|Number
860403|NCT00721409|Primary|Progression-Free Survival (PFS) at Phase 2 - Investigator Assessment|PFS was defined as the time from randomization (or the first dose of study treatment for non-randomized studies) to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first. PFS calculated as (Weeks or Months) = (first event date minus randomization or the first dose date plus 1) divided by 7 (or 30.44 if in months). PFS is usually characterized by the median, 25% percentile,75% percentile and their 95% Confidence Intervals (CIs).|From randomization date to date of first documentation of progression or death (assessed up to 41 months)|Intent-to-Treat (ITT) was used. This represented all randomized participants from Ph2P1 or Ph2P2 or Ph2P1+Ph2P2, where participants were classified according to the randomized treatment regardless of what treatment, if any, was received.||Months||95% Confidence Interval|Median
860404|NCT00721409|Primary|Number of Participants With Dose Limiting Toxicities at Phase 1|Dose limiting toxicity was defined as any of the following TEAEs occurring during the second cycle of treatment and possibly attributable to the combination of letrozole plus Palbociclib: 1. Grade 4 hematologic toxicity (including platelets <25,000/μL, ANC <500/μL). 2. Grade 3 neutropenia associated with a documented infection or fever ≥38.5°C. 3. Grade ≥3 non-hematologic toxicities, except those that have not been maximally treated (eg, nausea, vomiting, diarrhea, hypertension). 4. Delay by ≥1 week in receiving the next scheduled dose of either study treatment due to persisting treatment-related toxicities (platelet count <50,000/μL; ANC <1,000/μL; nonhematologic toxicities of Grade ≥3 severity). 5. Inability to deliver at least 80% of the planned Palbociclib or letrozole doses during Cycle 2 due to toxicity possibly attributable to the study treatment.|Cycle 2 (4 weeks)|Safety analysis set included all participants who received at least 1 dose of any agent of the combination.||Participants|||Number
860405|NCT00721409|Primary|Number of Participants With Treatment-Related Adverse Events at Phase 1|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Maximum treatment duration (approximately 55 months)|Safety analysis set included all participants who received at least 1 dose of any agent of the combination.||Participants|||Number
860406|NCT00721409|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs; All Causalities) at Phase 1|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Maximum treatment duration (approximately 55 months)|Safety analysis set included all participants who received at least 1 dose of any agent of the combination.||Participants|||Number
860407|NCT00719186|Secondary|Neonatal Complication Rate||September 2008 - December 2011|Neonatal complications reported per infant, an infant could have more than one complication.||participants|||Number
860408|NCT00719186|Secondary|Number of Serious Adverse Events||as few as 5 months, up to 16 months|||events|||Number
860409|NCT00719186|Secondary|Number of Ovulations||as few as 5 months, up to 16 months|||ovulations|||Number
860410|NCT00719186|Secondary|Number of Pregnancy||as few as 5 months, up to 16 months|||participants|||Number
860411|NCT00719186|Primary|Live Birth|The primary outcome measure is the occurrence of a live birth during the study period. Safety measures will be the number and type of reported adverse events in subjects and offspring.|as few as 5 months, up to 16 months|||participants|||Number
860412|NCT00690924|Primary|Grade III-IV Toxicities or Any Grade II Toxicities Lasting More Than 2 Weeks|"Number of participants with Adverse Events, Grade II lasting more than two weeks or Grade III or higher, graded according to CTEP Version 4 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
CTEP Version 4 of the CTCAE is identified and located at:
http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm."|3 months|All treated and eligible patients||participants|||Number
860413|NCT00581529|Secondary|Mean Percentage of Reference Volume Receiving 19.25 Gy and 38.5Gy for Patients With Acceptable and Unacceptable Cosmesis|One of the studies secondary outcomes was to evaluate the impact of short term accelerated partial breast radiation therapy on cosmetic results. To determine the association between dosimetric factors and cosmesis, the mean percentage of prescription dose received to WBV (Whole breast volume: corresponding region typically encompassed by traditional tangent fields) was compared among participants who developed fair/poor (F/P) cosmetic outcomes (unacceptable cosmesis) and participants who maintained excellent/good (E/G) cosmetic outcomes (acceptable cosmesis).|5 years|34 for patients were enrolled and treated. 2 patients were excluded from all analysis due to fair baseline cosmesis.||Percentage of reference volume||Full Range|Mean
860414|NCT00581529|Secondary|Dosimetric and Volumetric Differences Between Treatment Plans for Partial Breast Irradiation and Other Treatment Planning Methods|Dosimetric and volumetric differences between treatment plans for partial breast irradiation and other treatment planning methods for the target (partial breast) and organs at risk (e.g. heart, ipsilateral lung, contralateral breast)a subset of 20.|not specific|At the time the study was written, we planned to compare treatment methods. Over the course of the study, it was determined additional analysis was not needed due to the analysis and publication of this outcome by several other investigators.|||||
860415|NCT00581529|Primary|Percentage of Participants That Experience Cosmetic Adverse Events (AEs)|The primary outcome was to determine the rate of acute cosmetic adverse events and late cosmetic adverse events at follow-up visits over 5 years. To determine the rate of adverse events, the percentage of participants experiencing no cosmetic AEs, at least 1 grade 1 toxicity, at least 1 grade 2 toxicity, and at least 1 grade 3 toxicity were calculated.|5 years|34 for patients were enrolled and treated. 2 patients were excluded from all analysis due to fair baseline cosmesis. 2 additional patients underwent mastectomies and were therefore excluded from analysis (cosmesis could not be assessed at 5 years). 30 patients were analyzed.||percentage of participants|||Number
860416|NCT00581529|Primary|Rate of Local Control at 5 Years|The primary objective was to determine the rate of local control (the arrest of cancer growth at the site of origin) of cancer in the treated breast at 5 years following breast-conserving surgery and partial breast radiotherapy using IMRT.|5 years|34 for patients were enrolled and treated.||percentage of participants|||Number
860417|NCT00581256|Secondary|The Number of Participants That Experience Pericarditis and Pneumonitis|"To compare rates of pericarditis and pneumonitis by treatment arm.
Pericarditis (inflammation of the pericardium):
Grade1: Asymptomatic, ECG or physical exam; changes consistent with pericarditis Grade 2: Symptomatic pericarditis Grade 3: Pericarditis with physiologic consequences Grade 4: Life-threatening Pneumonitis (inflammation of the walls of the alveoli in the lungs) Grade 1: Asymptomatic, radiographic findings only Grade 2: Symptomatic, not interfering with ADL (activities of daily living) Grade 3: Symptomatic, interfering with ADL Grade 4: Life-threatening"|approx 1 year|||participants|||Number
860418|NCT00581256|Secondary|Number of Participants With New Lung Perfusion Defects|To compare changes in lung perfusion defects by treatment arm. Perfusion defects (PD) were assessed by comparing normalized perfusion distributions against our institution’s normal polar map databases for the left anterior descending artery (LAD).|baseline to approx 1 year|One patient randomized to the IMRT arm did not receive her post-RT lung SPECT scan therefore pre- and post-radiotherapy Lung SPECT scans were available for 53 patients.||participants|||Number
860419|NCT00581256|Secondary|Mean Percent Change in Ejection Fraction (LVEF)|To compare change in ejection fraction between treatment arms.|baseline to approx 1 year|||percent change||Full Range|Mean
860435|NCT00495469|Secondary|Number of Participants With Vital Signs of Potential Clinical Importance (PCI) at Any Time on Therapy|Systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR) were measured pre-dose in duplicate, after the participant has been lying quietly for 5 minutes, and then in duplicate 3 minutes after standing up. Participants were asked to refrain from smoking for at least 30 minutes prior to vital sign measurements.|Up to Week 12|Safety Population. Only those participants with data available at the indicated time points were analyzed.||Participants|||Count of Participants
860420|NCT00581256|Primary|The Number of Participants With a Significant Increase in Perfusion Defects (PD)|To compare the extent of new myocardial perfusion defects following breast cancer radiotherapy using the best standard 3-D radiotherapy technique, partially wide tangent fields, versus the best optimized technique. Perfusion defects (PD) were assessed by comparing normalized perfusion distributions against our institution’s normal polar map databases for the left anterior descending artery (LAD) using thresholds of 2.5-SD (standard deviation) and 1.5-SD below the normal mean. On the basis of interest variability, a PD increase greater than 5% or 10% was considered significant for 2.5- and 1.5-SD thresholds, respectively.|1 Year|||participants|||Number
860421|NCT00578331|Secondary|Average Number of Days of Rescue Medication Taken||Month 1 through Month 12|12 patients had missing average use of rescue medication data.||Days||Standard Deviation|Mean
860422|NCT00578331|Primary|Mean Response at Day 30 to the Patient-rated Relief Assessment Questionnaire|Mean Patient-Rated Relief Assessment at Day 30. The patient-rated relief assessment (PRRA) was a 4-point scale with 1=Complete Relief; 2=Moderate Relief; 3=Mild Relief; and 4=No Relief.|day 30|29 patients had missing mean patient-rated relief assessment data.||Unit on PRRA scale||Standard Deviation|Mean
860423|NCT00542425|Secondary|Change in Bone Mineral Density, Total Spine.|Total analyzable spine bone mineral density (BMD) was analyzed by DXA at Week 48.|12 months|The extension population included any patient who continued in the extended 24 weeks of treatment; N=55. 49 of the 55 extension patients had data available for analysis at Week 48.||Percent change from baseline||Standard Deviation|Mean
860424|NCT00542425|Secondary|Change in Bone Mineral Density, Total Hip.|Total analyzable hip bone mineral density (BMD) was analyzed by DXA at Week 24.|6 months|The intent to treat (ITT) population included any patient who received at least one dose of study medication; N=221. 182 of the 221 ITT patients had data available for analysis at Week 24.||Percent change from baseline||Standard Deviation|Mean
860425|NCT00542425|Secondary|Change in Bone Mineral Density, Femoral Neck.|Femoral neck bone mineral density (BMD) was analyzed by DXA at Week 24.|6 months|The intent to treat (ITT) population included any patient who received at least one dose of study medication; N=221. 182 of the 221 ITT patients had data available for analysis at Week 24.||Percent change from baseline||Standard Deviation|Mean
860426|NCT00542425|Primary|Change in Bone Mineral Density, Total Spine.|Total analyzable spine bone mineral density (BMD) was analyzed by DXA at Week 24.|6 months|The intent to treat (ITT) population included any patient who received at least one dose of study medication; N=221. 187 of the 221 ITT patients had data available for analysis at Week 24.||Percent change from baseline||Standard Deviation|Mean
860427|NCT00542425|Primary|Change in Marker of Bone Metabolism, PINP|PINP, N-terminal propeptide of type I procollagen, is a marker of anabolic bone growth.|6 months|The intent to treat (ITT) population included any patient who received at least one dose of study medication; N=221. 193 of the 221 ITT patients had data available for analysis at Week 24.||Percent change from baseline||Standard Deviation|Mean
860428|NCT00537290|Secondary|The Efficacy of Rituximab|Outcome measures scored as complete response(CR),partial(PR),and none(NR) at 24 weeks.For thrombocytopenia,CR defined as a platelet count of ≥150×109/μl,PR as 100–149,and NR as <100.For CVD,CR defined as the disappearance of cardiac lesions,PR as 50%improvement,and NR as no change.For skin ulcer,CR defined as disappearance,PR as 50% improvement,and NR as no change.For aPL nephropathy,CR defined as a normal serum creatinine level,inactive urinary sediment,and urinary protein:creatinine 0.5;PR as a serum cr level 15%above baseline,RBCs per high-power field 50%above baseline with no casts,50%improvement in the urinary prt:cr,and estimated GFR 10%above baseline;and NR as the absence of C/PR.For cognitive dysfunction,CR defined as normalization of the cognitive impairment index with 50%improvement,PR as abnormal index with 50%,and NR as no change.|24 weeks|All patients enrolled in the study||Participants|||Count of Participants
860429|NCT00537290|Primary|Number of Participants Experiencing Serious and Non Serious Adverse Events|Serious and non-serious adverse events were evaluated throughout 52 weeks + additional 4 months for the patients with low B cell counts.|52 weeks + additional 4 months if needed|All patients enrolled in the study.||Participants|||Count of Participants
860430|NCT00521885|Secondary|Deep Vein Thrombosis|Confirmed by Lower Extremity Ultra-sonogram|14 Days||||||
860431|NCT00521885|Primary|Bleeding Rate Study Day 1-14 (Minor vs Major) With 30 Day f/u|Bleeding Rate- Major bleeding defined as one or a combination of the following: Fatal; Bleeding at critical organ sites (intracranial, retroperitoneal, intraocular, pericardial, spinal or adrenal). Minor Bleeding defined as clinically overt bleeding that is not major bleeding.|14 days||||||
860432|NCT00495469|Secondary|Number of Participants With Abnormal Hematology Value of PCI at Any Time on Therapy|Hematology parameters: Hemoglobin, Hematocrit, Platelet count and White blood cells were assessed for abnormal PCI values. Participants were instructed to fast for at least 8 hours prior to all study visits for the collection of laboratory samples. Samples were collected at Baseline, Week 2, Week 4, Week 8, Week 12 and at Week 14 (follow up).|Up to Week 12|Safety population. Only those participants available at the specified time points were analyzed.||Participants|||Count of Participants
860433|NCT00495469|Secondary|Number of Participants With Abnormal Chemistry Value of PCI at Any Time on Therapy|Chemistry parameters: Albumin, Alkaline phosphatase, Alanine animotransferase, Aspartate aminotransferase, Total billirubin, Calcium, Carbon dioxide/Bicarbonate, Glucose, Potassium, Sodium, Phosphorus and Total protein were assessed for abnormal PCI values. Participants were instructed to fast for at least 8 hours prior to all study visits for the collection of laboratory samples. Samples were collected at Baseline, Week 2, Week 4, Week 8, Week 12 and at Week 14 (follow up).|Up to Week 12|Safety Population. Only those participants with data available at the indicated time points were analyzed.||Participants|||Count of Participants
860434|NCT00495469|Secondary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings at Any Time Post-Baseline|Full 12-lead ECGs were recorded at Randomization (Week 0), Week 4, and Week 12 or early withdrawal. If the QTc was >500 milliseconds on the locally read ECG recording, an additional 2 ECG recordings at 10 minute intervals were made at that visit. If the average QTc for the 3 recordings was >500 milliseconds, the participant was withdrawn from the study.|Up to Week 12|Safety Population. Only those participants with data available at the indicated time points were analyzed.||Participants|||Count of Participants
860436|NCT00495469|Secondary|Number of Participants With On-therapy Hypoglycemia|Participants were provided with a Daily Glucose Monitoring Log to record glucose meter readings and to record symptoms of hypoglycemia. A separate electronic case report form (eCRF) page was provided to capture events of hypoglycemia.|Up to Week 12|Safety Population.||Participants|||Count of Participants
860437|NCT00495469|Secondary|Number of Participants With Any On-therapy Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE was defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE was defined as any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment.|Up to Week 12|Safety Population consisted of all participants who received at least one dose of study medication.||Participants|||Count of Participants
860438|NCT00495469|Secondary|Mean Change From Baseline to Week 12 in Body Weight|Body weight measurement was taken at Baseline, Week 2, Week 4, Week 8, Week 12 and at Week 14 (follow up). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. Adjusted mean is presented as LS mean.|Baseline (Week 0) and Week 12|ITT Population with LOCF.||kilograms||Standard Error|Least Squares Mean
860439|NCT00495469|Secondary|Mean Change From Baseline to Week 12 in Total Cholesterol/HDL-c Ratio|Blood samples were collected at Baseline and at Week 12 (or early withdrawal). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. Adjusted mean is presented as LS mean.|Baseline (Week 0) and Week 12|ITT Population with LOCF. Only those participants with data available at the indicated time points were analyzed.||Ratio||Standard Error|Least Squares Mean
860440|NCT00495469|Secondary|Mean Change From Baseline to Week 12 in LDL-c/HDL-c Ratio|Blood samples were collected at Baseline and at Week 12 (or early withdrawal). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. Adjusted mean is presented as LS mean.|Baseline (Week 0) and Week 12|ITT Population with LOCF. Only those participants with data available at the indicated time points were analyzed.||Ratio||Standard Error|Least Squares Mean
860441|NCT00495469|Secondary|Mean Change From Baseline to Week 12 in High Density Lipoprotein Cholesterol (HDL-c)|Blood samples were collected at Baseline and at Week 12 (or early withdrawal). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. Adjusted mean is presented as LS mean.|Baseline (Week 0) and Week 12|ITT Population with LOCF. Only those participants with data available at the indicated time points were analyzed.||mmol/L||Standard Error|Least Squares Mean
860442|NCT00495469|Secondary|Mean Change From Baseline to Week 12 in Low Density Lipoprotein Cholesterol (LDL-c)|Blood samples were collected at Baseline and at Week 12 (or early withdrawal). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. Adjusted mean is presented as LS mean.|Baseline (Week 0) and Week 12|ITT Population with LOCF. Only those participants with data available at the indicated time points were analyzed.||mmol/L||Standard Error|Least Squares Mean
860443|NCT00495469|Secondary|Mean Change From Baseline to Week 12 in Total Cholesterol|Samples were collected at Baseline and at Week 12 (or early withdrawal). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. Adjusted mean is presented as LS mean.|Baseline (Week 0) and at Week 12|ITT Population with LOCF. Only those participants with data available at the indicated time points were analyzed.||mmol/L||Standard Error|Least Squares Mean
860444|NCT00495469|Secondary|Mean Change From Baseline to Week 12 in Triglycerides|Samples were collected at Baseline and at Week 12 (or early withdrawal). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. Adjusted mean is presented as LS mean.|Baseline (Week 0) and at Week 12|ITT Population with LOCF. Only those participants with data available at the indicated time points were analyzed.||mmol/L||Standard Error|Least Squares Mean
860445|NCT00495469|Secondary|Number of Participants Who Were Fasting Plasma Glucose (FPG) Responders at Week 12|Differences between treatment groups in the proportion of participants who achieved FPG targets of <7.0 millimoles per liter (mmol/L) (126 milligrams per deciliter [mg/dL]) and <7.8 mmol/L (140 mg/dL) at Week 12 in the ITT population with LOCF were assessed based on a logistic regression model with terms included for treatment and Baseline FPG. The proportion of participants who achieved the target of <5.5 mmol/L (100 mg/dL) at Week 12 within each treatment group were summarized only. Differences between treatment groups in the proportion of participants who achieved a clinically meaningful decreases from Baseline in FPG (1.7 mmol/L [>=30 mg/dL]) at Week 12 were assessed in the same manner.|Week 12|ITT Population. Only those participants with data available at the indicated time points were analyzed.||Participants|||Count of Participants
860446|NCT00495469|Secondary|Number of Participants Who Were HbA1c Responders at Week 12|Differences between treatment groups in the proportion of participants who achieved HbA1c targets of <=6.5% and <7% at Week 12 in the ITT population with LOCF were assessed based on a logistic regression model with terms included for treatment and Baseline HbA1c. Differences between treatment groups in the proportion of participants who achieved a clinically meaningful decreases from Baseline in HbA1c (>=0.7%) at Week 12 were assessed in the same manner.|Week 12|ITT Population. Only those participants with data available at the indicated time points were analyzed.||Participants|||Count of Participants
860465|NCT00425802|Primary|Overall Survival at 1 Year||1 year|Data for the remaining 10 patients was not fully collected or analyzed for publication||percentage of participants||95% Confidence Interval|Number
860447|NCT00495469|Secondary|Mean Change From Baseline to Week 12 in Fructosamine (Corrected)|The blood samples were collected at Baseline, Week 2, Week 4, Week 8, Week 12 and Week 14 (follow up). Participants were asked to be on fast for at least 8 hours prior to each study visits and collection of lab samples. Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. The primary analysis was performed on the ITT Population with LOCF. Adjusted mean is presented as LS mean.|Baseline (Week 0) and at Week 12|ITT Population. Only those participants with data available at the indicated time points were analyzed.||micromoles per liter (µmol/L)||Standard Error|Least Squares Mean
860448|NCT00495469|Secondary|Mean Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG)|The samples were collected at Baseline, Week 2, Week 4, Week 8, Week 12 and Week 14 (follow up). Participants were asked to be on fast for at least 8 hours prior to each study visits and collection of lab samples. Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. The primary analysis was performed on the ITT Population with LOCF. Adjusted mean is presented as LS mean.|Baseline (Week 0) and at Week 12|ITT Population. Only those participants with data available at the indicated time points were analyzed.||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
860449|NCT00495469|Secondary|Mean Change From Baseline in HbA1c at Weeks 4 and 8|The blood samples were collected at Baseline, Week 4, Week 8 and at Week 12 (or early withdrawal). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 4 and 8 minus Baseline value. The primary analysis was performed on the ITT Population with LOCF.|Baseline (Week 0) and at Week 4 nad 8|ITT Population. Only those participants available at the specified time points were analyzed.||Percentage||Standard Deviation|Mean
860450|NCT00495469|Primary|Mean Change From Baseline in Hemoglobin A1c (Glycosylated Hemoglobin) (HbA1c) at Week 12|The blood samples were collected at Baseline, Week 4, Week 8 and at Week 12 (or early withdrawal). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. The primary analysis was performed on the Intent-to-Treat (ITT) Population with Last observation carried forward (LOCF). Adjusted mean is presented as least square (LS) mean.|Baseline (Week 0) and at Week 12|ITT Population consisted of all randomized participants who received at least one dose of study medication, had a Baseline assessment, and had at least one corresponding on-therapy efficacy assessment. Only those participants with data available at the indicated time points were analyzed.||Percentage||Standard Error|Least Squares Mean
860451|NCT00442611|Secondary|Change in Scleroderma Health Assessment Questionnaire|"The HAQ Disability Index (HAQ-DI) includes 20 items in 8 functional domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities) assessing the patient’s usual abilities in the past seven days. Each item is scored on a 0-3 scale (0=without any difficulty; 1=with some difficulty; 2=with much difficulty; 3=unable to do). The use of assistive devices for any domain increases the domain score by 1 point to a maximum of 3. The overall score is calculated by summing the highest item score in each of the domains and dividing the sum by 8, with an overall score of 0 indicating no disability, and a score of 3 indicating severe disability.
The time points compared were 6 months to baseline (6 months minus baseline)."|6 months|Participants with available data were analyzed.||HAQ-DI score||Standard Deviation|Mean
860452|NCT00442611|Secondary|Change in Pulmonary Function Tests|FVC (Forced Vital Capacity) is the amount of air that can be forcibly exhaled from the lungs after taking the deepest possible breath. DLCO (Diffusing capacity of the lung for carbon monoxide) is the extent to which oxygen passes from the lungs to the blood.|6 months|Participants with available data were analyzed.||% Predicted||Standard Deviation|Mean
860453|NCT00442611|Secondary|Digital Ulcerations at Baseline and Month 6||Baseline; Month 6|||ulcers||Standard Deviation|Mean
860454|NCT00442611|Secondary|Hand Extension at Baseline and Month 6||Baseline; Month 6|||mm||Standard Deviation|Mean
860455|NCT00442611|Secondary|Oral Aperture at Baseline and Month 6||Baseline; Month 6|||mm||Standard Deviation|Mean
860456|NCT00442611|Primary|Change in Modified Rodnan Skin Score|Modified Rodnan Skin Score measures skin thickness and is the sum of scores from 17 surface anatomic areas rated on a 0–3 scale (0=normal skin; 1=mild thickness; 2=moderate thickness; 3=severe thickness with inability to pinch the skin into a fold). Total modified Rodnan Skin Score ranges from 0 (best possible outcome) to 51 (worst possible outcome).|6 months|||MRSS score||Standard Deviation|Mean
860457|NCT00425802|Secondary|Immune Reconstruction/CD4+ Count at 1 Year||1 year|Data for the remaining 10 patients was not fully collected or analyzed for publication||cells/microliter||Inter-Quartile Range|Median
860458|NCT00425802|Secondary|Immune Reconstruction/CD4+ Count at 6 Months||6 months|Data for the remaining 10 patients was not fully collected or analyzed for publication||cells/microliter||Inter-Quartile Range|Median
860459|NCT00425802|Secondary|Response to Treatment||2 years|Data for the remaining 10 patients was not fully collected or analyzed for publication||Participants|||Count of Participants
860460|NCT00425802|Secondary|Immune Reconstruction/CD4+ Count at 3 Months||3 months|Data for the remaining 10 patients was not fully collected or analyzed for publication||cells/microliters||Inter-Quartile Range|Median
860461|NCT00425802|Secondary|Incidence of Chronic GVHD at 1 Year||1 year|Data for the remaining 10 patients was not fully collected or analyzed for publication||percentage of participants||95% Confidence Interval|Number
860462|NCT00425802|Secondary|Incidence of Moderate to Severe Grades II to IV Graft Versus Host Disease (GVHD) at 100 Days||100 days|Data for the remaining 10 patients was not fully collected or analyzed for publication||percentage of patients||95% Confidence Interval|Number
860463|NCT00425802|Secondary|Time to Platelet Engraftment||1 year|Data for the remaining 10 patients was not fully collected or analyzed for publication||days||Full Range|Median
860464|NCT00425802|Secondary|Time to Neutrophil Engraftment||2 years|Data for the remaining 10 patients was not fully collected or analyzed for publication||days||Full Range|Median
860467|NCT00422058|Secondary|Change From Baseline in Blood Pressure at Week 20|Calculated as mean blood pressure at week 20-baseline.|Week 0, week 20|ITT (intention to treat) analysis set using (LOCF) last observation carried forward is all randomised and exposed subjects from the double-blind period, who have been exposed to at least one dose of trial product||mmHg||Standard Deviation|Mean
860468|NCT00422058|Secondary|Change From Baseline in Waist Circumference at Week 104|Calculated as mean waist circumference at week 104-baseline.|Week 0, week 104|ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).||cm||Standard Deviation|Mean
860469|NCT00422058|Secondary|Change From Baseline in Waist Circumference at Week 20|Calculated as mean waist circumference at week 20-baseline.|Week 0, week 20|ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).||cm||Standard Deviation|Mean
860470|NCT00422058|Secondary|Change From Baseline in Adiponectin at Week 104|Calculated as mean adiponectin at week 104-baseline. A low adiponectin level is associated with greater cardiovascular risk|Week 0, week 104|ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).||mcg/mL||Standard Deviation|Mean
860471|NCT00422058|Secondary|Change From Baseline in Adiponectin at Week 20|Calculated as mean adiponectin at week 20-baseline. A low adiponectin level is associated with greater cardiovascular risk|Week 0, week 20|ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).||mcg/mL||Standard Deviation|Mean
860472|NCT00422058|Secondary|Change From Baseline in Fibrinogen at Week 104|Calculated as mean fibrinogen at week 104 - baseline. High fibrinogen is associated with greater cardiovascular risk|Week 0, week 104|ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).||g/L||Standard Deviation|Mean
860473|NCT00422058|Secondary|Change From Baseline in Fibrinogen at Week 20|Calculated as mean fibrinogen at week 20 - baseline. High fibrinogen is associated with greater cardiovascular risk|Week 0, week 20|ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).||g/L||Standard Deviation|Mean
860474|NCT00422058|Secondary|Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 104|Calculated as mean PAI-1 (plasminogen activator inhibitor 1) at week 104-baseline. High PAI-1 is associated with greater cardiovascular risk|Week 0, week 104|ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).||U/mL||Standard Deviation|Mean
860475|NCT00422058|Secondary|Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 20|Calculated as mean PAI-1 (plasminogen activator inhibitor 1) at week 20-baseline. High PAI-1 is associated with greater cardiovascular risk|Week 0, week 20|ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).||U/mL||Standard Deviation|Mean
860476|NCT00422058|Secondary|Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 104|Calculated as mean hsCRP (highly sensitive C-reactive protein) at week 104- baseline. High hsCRP level is associated with greater cardiovascular risk|Week 0, week 104|ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).||mg/L||Standard Deviation|Mean
860477|NCT00422058|Secondary|Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 20|Calculated as mean hsCRP (highly sensitive C-reactive protein) at week 20-baseline. High hsCRP level is associated with greater cardiovascular risk|Week 0, week 20|ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).||mg/L||Standard Deviation|Mean
860478|NCT00422058|Secondary|Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 104|Calculated as mean HbA1c (glycosylated haemoglobin A1c) at week 104 - baseline|Week 0, week 104|ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).||percentage (%) of total haemoglobin||Standard Deviation|Mean
860479|NCT00422058|Secondary|Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 20|Calculated as mean HbA1c (glycosylated haemoglobin A1c) at week 20 - baseline|Week 0, week 20|ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).||percentage (%) of total haemoglobin||Standard Deviation|Mean
860480|NCT00422058|Secondary|Change From Baseline in Fasting Insulin at Week 104|Calculated as mean fasting insulin at week 104 - baseline|Week 0, week 104|ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).||pmol/L||Standard Deviation|Mean
860481|NCT00422058|Secondary|Change From Baseline in Fasting Insulin at Week 20|Calculated as mean fasting insulin at week 20 - baseline|Week 0, week 20|ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).||pmol/L||Standard Deviation|Mean
860482|NCT00422058|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 104|Calculated as mean fasting plasma glucose at week 104 - baseline|Week 0, week 104|ITT (intention to treat) analysis set using (LOCF) last observation carried forward is all randomised and exposed subjects from the double-blind period, who have been exposed to at least one dose of trial product||mmol/L||Standard Deviation|Mean
860483|NCT00422058|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 20|Calculated as mean fasting plasma glucose at week 20 - baseline|Week 0, week 20|ITT (intention to treat) analysis set using (LOCF) last observation carried forward is all randomised and exposed subjects from the double-blind period, who have been exposed to at least one dose of trial product||mmol/L||Standard Deviation|Mean
860484|NCT00422058|Secondary|Mean Change From Baseline in Body Weight at Week 104|Calculated as mean body weight at week 104 - baseline|Week 0, week 104|ITT (intention to treat) analysis set using LOCF (last observation carried forward) is all randomised and exposed subjects from the double-blind period, who have been exposed to at least one dose of trial product.||kg||Standard Deviation|Mean
860485|NCT00422058|Primary|Mean Change From Baseline in Body Weight at Week 20|Calculated as mean body weight at week 20 - baseline|Week 0, week 20|ITT (intention to treat) analysis set using LOCF (last observation carried forward) is all randomised and exposed subjects from the double-blind period, who have been exposed to at least one dose of trial product.||kg||Standard Deviation|Mean
860486|NCT00359736|Primary|Change in 6-minute Walk Test|Distance in meters -- Distance (meters) walked in 6 minutes|0 - 6 months|||meters||Standard Deviation|Mean
860487|NCT00359736|Secondary|Dyspnea Score (Borg Scale)|"The Dyspnea score or Borg Rating of Perceived Exertion (RPE) Scale score is a subjective rating of perceived exertion. In medicine this is used to document the patient's effort and exertion, breathlessness and fatigue during a physical test.
The Dyspnea score ranges from 0 (No breathlessness at all) to 10 (Maximum or extremely strong breathlessness).
IN this study the Specific Objective 2 was to assess and compare changes from baseline in pre- and post-exercise dyspnea in the sildenafil and placebo control groups."|0 - 6 months|||units on a scale||Standard Deviation|Mean
860488|NCT00331344|Secondary|Time to Progression (Phase II)|Measured from the start of protocol therapy until RECIST (Response Evaluation Criteria In Solid Tumors Criteria) v1.0 progression. Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Every 3 months until cancer progression/excessive toxicity or death|||months||95% Confidence Interval|Median
860489|NCT00331344|Primary|Dose Limiting Toxicities for Each Dose Level of Ixabepilone, Mitoxantrone Hydrochloride, and Prednisone in Patients With Hormone-refractory Metastatic Prostate Cancer That Progressed During or After Taxane-based Chemotherapy (Phase I).|Cohorts of 3 patients will be enrolled at each dose level; if 1 dose limiting toxicity (DLT) is observed then the cohort will be expanded to 6 patients. If a second DLT is observed, the previous dose level will be considered the maximum tolerated dose (MTD). If all observed DLT are due to neuropathy (specific to ixabepilone), then we would consider the previous dose level of Ixabepilone the MTD for that drug, and escalate mitoxantrone hydrochloride as described above to a maximum dose of 12 mg/m^2. Toxicities will be tabulated by grade for each dose cohort and overall for all patients accrued to the phase I study.|Course 1 (first 21 days)|Dose escalation safety study (Phase I)||Participants|||Count of Participants
860490|NCT00331344|Primary|Safety of the Combination of Ixabepilone, Mitoxantrone Hydrochloride, and Prednisone in Patients With Hormone-refractory Metastatic Prostate Cancer That Progressed During or After Taxane-based Chemotherapy (Phase I)|This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The cumulative grade 3 or higher adverse events for all dose levels are noted below and in the table of adverse events.|Every 21 days until cancer progression/excessive toxicity or death|Phase I dose escalation study participants||Adverse Events (above threshold)|||Number
860491|NCT00331344|Primary|Proportion Responding to Treatment With of the Combination of Ixabepilone and Mitoxantrone Hydrochloride With Prednisone in Hormone Refractory Prostate Cancer Patients Who Have Had Prior Taxane Chemotherapy Based Upon a PSA Decline of > 50% (Phase II)|"Descriptive statistics will be calculated to characterize the disease and treatment factors including the proportion responding with a 95% confidence interval. If accrual is completed and more than 15 of 58 patients show > 50% Prostate Specific Antigen (PSA) declines after 3 courses, then the null hypothesis of a 20% response proportion will be rejected. PSA declines for individual patients will be plotted in the form of a waterfall diagram of maximal PSA declines.
58 patients were enrolled for phase II, two were ineligible so 56 patients were analyzed."|Every 3 courses until cancer progression/excessive toxicity or death|||Participants|||Count of Participants
860492|NCT00266864|Secondary|Resting Energy Expenditure|Resting Energy Expenditure was obtained by the measurement of exhaled air from fractions of mixed expired oxygen and carbon dioxide by a process known as indirect calorimetry. Data was collected under steady state conditions. Participants arrived at the laboratory for testing between the hours of 8:00 and 10:00 in the morning, following a 12-h fast, with a minimum of 24 h free from any type of exercise.|12 months|||kcal/day||Standard Deviation|Mean
860493|NCT00266864|Primary|Dual Energy X-ray Absorptiometry (DXA) Assessment of Lean Tissue Mass (LTM)|Dual energy X-ray absorptiometry assessment of lean tissue mass (LTM) at 12 months. Total body scans were performed and the energy level used for each total body scan was based on subject thickness (e. g., thin, standard, or thick). To analyze the results of each total body scan, proprietary software algorithms were used to segment the body into trunk, pelvis, and upper and lower extremities using the standard regions of interest. In accordance with International Society for Clinical Densitometry guidelines, total body scans were repeated on 30 spinal cord injury subjects by the “on-and-off -the-table” method (i. e., subjects were repositioned between scans) and our precision error was equal to 1.2 % for LTM.|12 months|||kilograms||Standard Deviation|Mean
860494|NCT00249470|Secondary|HIV Risk Behaviors|Report no injection drug use or crack cocaine use.|every month for 6 months|The data represent the mean percentage of participants that reported no injection drug use or crack cocaine use. Missing assessments were considered positive (i.e., injection drug or crack cocaine use).||percentage of participants||Full Range|Mean
860495|NCT00249470|Secondary|Percent Opiate Negative|(total number of opiate-negative urine samples divided by the total number of urine samples provided)*100|every month for 6 months|intent to treat||percentage of opiate negative||Full Range|Mean
860496|NCT00249470|Primary|Cocaine Abstinence|Percentage of Monday, Wednesday, Friday urine samples that are negative for cocaine|6 months|||percentage of cocaine negative||Full Range|Mean
860497|NCT00223795|Primary|Peak Vertical Force on Affected Limb|An in-shoe dynamic, pressure distribution system (Pedar-X System, Novel Electronics, Inc., St. Paul, MN) was utilized to measure the vertical ground reaction force at the baseline visit and at the end of the first intervention period (two months) gait evaluations for both the control arm and cane user arm. The control arm was not given a cane to use at home during the two month intervention period. Peak vertical force on the affected limb was measured in the laboratory setting when both control group and cane user group walked with and without a cane at baseline and at the end of the first intervention period (2 months).|Baseline and end of first intervention period (2 months)|||N/kg||Standard Deviation|Mean
860498|NCT00005044|Secondary|Treatment-induced Morbidity (Highest Grade Toxicity Reported Per Patient)|Acute drug therapy and radiation (<= 90 days from start of RT) toxicity was graded using the Common Toxicity Criteria (CTC) v.2.0 criteria; late toxicity was graded using the Radiation Therapy Oncology Group (RTOG)/European Organisation for Research and Treatment of Cancer (EORTC) Late Radiation Morbidity Scoring schema. Grade refers to the severity of the toxicity. The CTC v2.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on this general guideline: Grade 1 Mild toxicity, Grade 2 Moderate toxicity, Grade 3 Severe toxicity, Grade 4 Life-threatening or disabling toxicity, Grade 5 Death related to toxicity. The highest grade acute and late toxicity was determined for each patient.|From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)|Eligible patients with adverse event data in corresponding time frame (during hormone therapy and <=90 days from RT start; > 90 days from RT start)||percentage of participants|||Number
860499|NCT00005044|Secondary|Time to Second Biochemical Failure (SBF) (10-year Rates Reported)|Time to SBF measured from date of randomization to the date of PSA increase of ≥1.0 ng/mL (from the nadir PSA after completion of protocol-specified therapy) after salvage androgen suppression was started; competing risks LRP, DM, and death without SBF; all others are censored. SBF is estimated using the cumulative incidence method. Ten-year rates are reported.|From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)|Eligible patients with follow-up data||percentage of participants||95% Confidence Interval|Number
860500|NCT00005044|Secondary|Time to First Biochemical Failure (BF) (10-year Rates Reported)|"Protocol definition: Time to BF measured from date of randomization to first of (1) the midway date between the last non-rising PSA and the first rising PSA of three consecutive rises or (2) the date of the initiation of salvage hormone therapy; competing risks are LRP, DM, and death without BF; all others are censored.
Phoenix definition: Time to BF measured from date of randomization to first of (1) the date of documented rise of 2 ng/ml above the post-treatment(RT end date) nadir or (2) the date of the initiation of salvage hormone therapy; competing risks are LRP, DM, and death without BF; all others are censored. For both definitions BF is estimated using the cumulative incidence method. Ten year rates reported."|From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)|Eligible patients with follow-up data||percentage of participants||95% Confidence Interval|Number
860501|NCT00005044|Secondary|Clinical Patterns of Tumor Recurrence: Time to Locoregional Progression (LRP) and Time to Distant Metastasis (DM) (10 Year Rates Reported)|Time to distant metastasis measured from date of randomization to date of documented distant metastasis; competing risks are BF, LRP, and death without DM; all others are censored. Time to locoregional progression measured from date of randomization to date of documented local or regional progression; competing risks are BF [protocol definition- first of (1) the midway date between the last non-rising PSA and the first rising PSA of three consecutive rises or (2) the date of the initiation of salvage hormone therapy], DM, and death without LRP; all others are censored. LRP and DM are estimated using the cumulative incidence method. Ten -year rates are reported.|From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)|Eligible patients with follow-up data||percentage of participants||95% Confidence Interval|Number
860502|NCT00005044|Secondary|Disease-free Survival (DFS) (10-year Rates Reported)|Disease-free survival time is defined as time from randomization to the date of disease progression or death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. Ten-year rate is reported.|From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)|Eligible patients without follow-up data||percentage of participants||95% Confidence Interval|Number
860503|NCT00005044|Secondary|Overall Survival (OS) (10-year Rates Reported)|Survival time is defined as time from randomization to the date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. Ten-year rate is reported.|From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)|Eligible patients with follow-up data||percentage of participants||95% Confidence Interval|Number
860504|NCT00005044|Primary|Disease-specific Survival (DSS) (10-year Rates Reported)|Disease-specific survival time is measured from date of randomization to death due to prostate cancer based on study chair review, with prostate-cancer death defined as (1) primary cause of death certified as due to prostate cancer, (2) complication of therapy, irrespective of disease status, (3) disease progression in the absence of any anti-tumor therapy, or (4) a 1.0 ng/ml-exceeding-rise in serum prostate-specific antigen (PSA) level on at least two consecutive occasions that occurs during or after salvage androgen suppression therapy. Death due to other causes is considered a competing risk. All others are censored. DSS is estimated using the cumulative incidence method. Ten-year rate is reported.|From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)|Eligible patients with follow-up data||percentage of participants||95% Confidence Interval|Number
